CN109730697A - Device for collecting bodily fluid samples - Google Patents

Abstract

The present invention relates to the devices for collecting humoral sample.Described device includes: at least two sample collection paths, is configured for for the humoral sample being sucked into described device from the single end for the described device being in contact with the subject, so that fluid sample to be separated into the sample of two separation；Second part, it includes multiple sample vessel for receiving the humoral sample being collected in the sample collection path, the sample vessel can be operatively engaged to be in fluid communication with the sample collection path, then when establishing fluid communication, the vessel provide power so that the major part of described two isolated samples to be moved in the vessel from the access.

Description

Device for collecting bodily fluid samples

This application is the international application date of December 5, 2013, the international application number is PCT/US2013/000268, the application number entering the Chinese national phase is 201380072120.6, and the title is "Systems and devices for the collection, transportation and processing of body fluid samples. and method" of the divisional application for the invention patent application.

Background technique

Blood samples for laboratory testing are usually obtained by means of venipuncture, which usually involves inserting a hypodermic needle into a subject's vein. Blood drawn by the hypodermic needle can be drawn directly into a syringe or into one or more sealed vials for subsequent processing. When venipuncture may be difficult or impractical, such as in neonates, a non-venipuncture such as a heel stick or other alternative site puncture may be used to draw a blood sample for testing. After a blood sample is collected, the drawn sample is usually packaged and transferred to a processing center for analysis.

Unfortunately, conventional sample collection and detection techniques for bodily fluid samples have shortcomings. For example, in addition to the most basic tests, currently available blood tests typically require the drawing of a relatively large volume of blood from a subject. Due to the large volume of blood, drawing blood from an alternative sampling site on the subject (which can be less painful and/or less invasive) is often disadvantageous because it does not yield the volume of blood required for conventional testing methods . In some cases, patient anxiety associated with venipuncture may reduce patient compliance with the testing protocol. Additionally, transporting small volumes of sample fluid while still maintaining sample integrity can be problematic.

SUMMARY OF THE INVENTION

At least some or all of the embodiments described in this disclosure overcome at least some of the disadvantages associated with the prior art. While the embodiments herein are generally described in the context of obtaining a fluid sample, such as, but not limited to, a blood sample, it should be understood that the embodiments herein are not limited to blood samples, and may also be adapted to collect one or more Other fluids or one or more bodily samples for analysis.

In one embodiment described herein, a device for collecting a body fluid sample is provided. In embodiments, the body fluid may be blood. In embodiments where blood is collected, this embodiment may be useful for accurately collecting small volumes of bodily fluid samples typically associated with non-venous blood draws. In one non-limiting example, the sample volume is about 1 mL or less. Optionally, the sample volume is about 900 uL or less. Optionally, the sample volume is about 800 uL or less. Optionally, the sample volume is about 700 uL or less. Optionally, the sample volume is about 600 uL or less. Optionally, the sample volume is about 500 uL or less. Optionally, the sample volume is about 400 uL or less. Optionally, the sample volume is about 300 uL or less. Optionally, the sample volume is about 200 uL or less. Optionally, the sample volume is about 100 uL or less. Optionally, the sample volume is about 90 uL or less. Optionally, the sample volume is about 80 uL or less. Optionally, the sample volume is about 70 uL or less. Optionally, the sample volume is about 60 uL or less. Optionally, the sample volume is about 50 uL or less.

In one non-limiting example, the device may be used to directly divide the body fluid sample into two or more distinct portions, which are then deposited into their corresponding sample vessels. In one non-limiting example, the device includes a first portion having at least two sample collection channels configured to draw a fluid sample to the sample collection via a first type of power channels, wherein one of the sample collection channels has an inner coating designed to mix with a fluid sample, and the other of the sample collection channels has another inner coating that is chemically different from the inner coating coating. The sample collection device includes a second portion that includes a plurality of sample vessels for receiving the bodily fluid sample collected in the sample collection channel, the sample vessels operably engageable with The collection channels are in fluid communication such that when fluid communication is established, the vessel provides a second power, different from the first power, to move a substantial portion of the bodily fluid sample from the channel into the sample vessel . The sample vessels may be arranged such that mixing of the fluid sample between the vessels does not occur. The device can be used to collect blood or other bodily fluids. Collection of blood from a vein can be relatively quick; however, non-venous draws can take a longer period of time to obtain the desired volume of sample, and early introduction of channel-coatable materials, such as anticoagulants, can prevent the passage of blood during collection premature blockage.

In another embodiment described herein, a device for collecting a body fluid sample is provided. The device includes a first portion including a plurality of sample collection channels, wherein at least two of the channels are configured to simultaneously draw a fluid sample into the at least two sample collection channels via a power of a first type in each of them. The device may also include a second portion including a plurality of sample vessels for receiving the bodily fluid sample collected in the sample collection channel, wherein the sample vessels have a first condition and a second condition. two conditions, wherein the sample vessel is not in fluid communication with the sample collection channel in the first condition, and the sample vessel is operably engageable in fluid communication with the collection channel in the second condition, Then when fluid communication is established, the sample vessel provides a second power, different from the first power, to move the bodily fluid sample from the channel into the sample vessel. In embodiments, the power to move the bodily fluid may include derived from capillary action, reduced pressure (eg, a vacuum or partial vacuum that draws fluid into a location with reduced pressure), increased pressure ( For example, to force fluid out of a location with increased pressure), wicking material, or other means.

In still further embodiments described herein, there is provided a method comprising metering a minimum amount of sample into at least two channels by using a sample collection device having at least two of the sample collection channels Each of the sample collection channels is configured to simultaneously draw a fluid sample into each of the at least two sample collection channels via a power of the first type. After a desired amount of sample fluid has been confirmed to be in the collection channel, fluid communication is established between the sample collection channel and the sample vessel, whereupon the vessel provides a different first power than was used to collect the sample a second power to move the bodily fluid sample from the channel into the vessel. In some alternative embodiments, devices that use only a single channel to collect the bodily fluid or devices that have multiple channels but do not collect bodily fluid simultaneously are not excluded. Optionally, the collection of the sample fluid is performed without the use of a wicking material.

In one embodiment, there is a discrete amount of time between sample collection and introduction of the sample into the sample pretreatment device. In one non-limiting example, the process is a discontinuous process. The sample collection takes place at one processing station and the sample is then taken to a second station. This second station can be in the sample building. Alternatively, the second station may be located at another location, wherein the sample needs to be reached by foot, drive, air, transport, placement in a transport device, or in a transport container to reach the second location. In this way, there are discrete pauses in processing to allow for time associated with sample transport.

In another embodiment herein, one or more separation gels may also be included in the sample vessel such that the gels will separate the cell-free portion of the whole blood from the cellular portion of the sample or other solid or The semi-solid fraction was phase separated. Such a gel or other similar separation material may be contained in the sample vessel before, during or after introduction of the sample into the sample vessel. The separation material may have a density between the densities of the cells and the solution components so that the material passes during separation (such as by centrifugation) to a location between the solution sample layer and the non-solution sample layer , while separating the sample components. After centrifugation, the separation material stops flowing and remains as a soft barrier between the layers. In some embodiments, the separation material can be further processed to harden it into a more rigid barrier. In one non-limiting example, the release material may be a UV curable material such as, but not limited to, a thixotropic gel of a sorbitol-based gelling agent in a diacrylate oligomer. The sample vessel may expose the entire vessel, or alternatively the portion with the UV curable material, to UV light for a period of time such as, but not limited to, 10 to 30 seconds to harden the material. Such hardening may involve cross-linking of the material in the UV curable material. Alternatively, the UV curable material may be used in conjunction with conventional separation gel materials such that only one side (solution side or solid side) is in contact with the UV curable material. Alternatively, the UV curable material can be used with a third material such that the UV curable material is located between the two separate materials and is not in direct contact with the solution and non-solution portions of the sample.

Bodily fluid samples can be collected by the devices disclosed and described herein. Methods of collecting bodily fluids using these devices are disclosed and described herein. Bodily fluid samples, such as samples that have been collected by the devices and/or methods disclosed and described herein, can be transported from the sample collection site to one or more other sites.

In at least one embodiment described herein, a method for physically transporting a small volume of bodily fluid in liquid form from one location to another is provided. By way of non-limiting example, the sample is collected in liquid form at the collection site, transported in liquid form, and arrives in liquid form at the analysis site. In many embodiments, the liquid form during transport is not retained in a porous matrix, wicking material, webbing, or similar material that would prevent extraction of the sample in liquid form at the target site. In one embodiment, the small volume of sample in each sample vessel is in the range of about 1 ml to about 500 microliters. Alternatively, the small volume is in the range of about 500 microliters to about 250 microliters. Alternatively, the small volume is in the range of about 250 microliters to about 100 microliters. Optionally, the small volume is in the range of about 100 microliters to about 50 microliters. Alternatively, the small volume is in the range of about 80 microliters to about 40 microliters. Alternatively, the small volume is in the range of about 40 microliters to about 1 microliter. Alternatively, the small volume is in the range of about 1 microliter to about 0.3 microliter. Optionally, the small volume is in the range of about 0.3 microliters or less.

As disclosed and described herein, a shipping container can include components configured to receive and retain sample vessels. In embodiments, an assembly configured to receive and retain a sample vessel may be configured to receive and retain a plurality of sample vessels. In an embodiment, such an assembly may comprise a flat plate, such as a tray. In embodiments, such a component (e.g., a plate) can include an opening (e.g., a slot, hole, or receptacle) having an inner surface configured to receive a sample vessel. In embodiments, the shipping container may include an assembly that includes a plurality of openings (e.g., slots, holes, or receptacles), each of the plurality of openings having an inner surface configured to receive a sample vessel. In embodiments, such an inner surface may be substantially complementary, at least in part, to the outer surface of the sample vessel, or a portion thereof.

In another embodiment described herein, the shipping container can provide a high density of sample vessels per unit area that are held in a fixed manner during shipping but are removable at a target location. In one non-limiting example, the sample vessels are positioned in an array, wherein there are at least six sample vessels per square inch when the array is viewed from top to bottom. Optionally, there are at least eight sample vessels per square inch when the array is viewed from top to bottom. Optionally, there are at least ten sample vessels per square inch when the array is viewed from top to bottom. Any conventional technique for shipping multiple samples typically uses large bags, where the sample vessels are in a loose, unconstrained form. In some embodiments, the shipping container can accommodate certain sample vessels, such as those from the same subject, that are closer together than horizontally or otherwise spaced adjacent sample vessels so that they can be Visually identified as being from a common subject. Optionally, the transport container has an opening to receive a carrier that holds together one or more sample vessels, wherein those vessels have something in common, such as but not limited to being from the same subject.

In embodiments, the sample vessel is adapted to help retain the sample in liquid form. In embodiments, the sample is processed prior to reaching the sample vessel in a manner suitable for retaining the sample in liquid form. For example, the sample vessel can include an anticoagulant, or the sample can be treated with an anticoagulant before or during transport to or into the sample vessel. In embodiments, the anticoagulant may be selected from heparin (eg, lithium or sodium heparin), EDTA, 4-hydroxycoumarin, vitamin K antagonist (VKA) anticoagulants, anticoagulants, or other additives. In addition to high density per unit area, some embodiments of the shipping container also contain high density samples, including those from multiple different subjects. By way of non-limiting example, the shipping container may have four samples from one subject, two samples from another subject, etc., until most or all of the available openings in the shipping container are available. filling.

It will be appreciated that each sample can be sent individually for the selected analysis and, in at least one embodiment, is not grouped in the shipping container based on the assay to be performed. By way of non-limiting example, not all samples in a shipping container are collected for the same assay. Traditional testing systems can group together samples destined for identical testing just for shipping. In at least one embodiment herein, there are multiple samples, each designated to receive its own set of assays. In such embodiments, the grouping in the shipping container is not limited to only those samples for the same assay. This can further simplify sample handling as there is no need to further separate sample transport based on the assay to be performed. Some embodiments of the shipping container contain samples from at least three or more different patients. Some embodiments of the shipping container contain samples from at least five or more different patients. Some embodiments of the shipping container contain samples from at least ten or more different patients. Some embodiments of the shipping container contain samples from at least twenty or more different patients.

By way of non-limiting example, one embodiment described herein may optionally use one or more trays having slots for receiving the sample vessels and/or sample vessel holders. In one embodiment, the tray also doubles as a holding device during storage in a cooling chamber while awaiting more samples or shipping, and in one embodiment, the tray itself can also be cleaned and sterilized because In some embodiments, the pallet is removable from the shipping container. In some embodiments, the pallet in the shipping container may be held parallel to the covering of the shipping container. Optionally, the tray may be held inside the shipping container at an angle to the covering of the shipping container. Optionally, the tray is non-removably secured to the shipping container. Optionally, the tray is integrally formed with the shipping container itself. Optionally, multiple pallets of the same or different sizes or configurations may be placed inside the shipping container.

In yet another embodiment described herein, a method is provided for transporting small volume sample vessels using a shipping container having an integrated thermal control unit and/or material that provides active and/or passive cooling. In one embodiment, the thermal control material may be, but is not limited to, an embedded phase change material (PCM) that maintains the temperature at a previous or desired temperature. By way of non-limiting example, the phase change material can resist temperature changes around a critical temperature at which the material undergoes a phase change. If the PCM is embedded, the vessel and passive cooling element can be one and the same. Optionally, the shipping container may use an active cooling system. Optionally, the shipping container may use an active cooling system to maintain and/or extend the cooling time associated with passive cooling components. In embodiments, the shipping container may include a material having a high heat capacity (ie, having a high heat capacity as compared to materials such as plastic or polymeric materials), and may include a substantial amount of such a high heat capacity material, which is used for an extended period of time The segment is effective to maintain at least a portion of the shipping container at or near the desired temperature.

Optionally, the method includes a single step for transferring a plurality of sample vessels from different subjects from a temperature-controlled storage area into a shipping container. By way of non-limiting example, this single step can simultaneously transfer twenty-four or more sample vessels from a storage location to a fixed location in the shipping container. Optionally, this single step can simultaneously transfer thirty-six or more sample vessels from a storage location to a fixed location in the shipping container. Optionally, this single step can simultaneously transfer forty-eight or more sample vessels from a storage location to a fixed location in the shipping container. In such embodiments, the tray may initially be in a thermally controlled environment, such as, but not limited to, a refrigerator, wherein samples from various subjects are collected over time until a desired number is reached . In one such embodiment, the tray holding the one or more sample vessels in the transport container is the same tray holding the sample vessels in the storage area. Alternatively, the tray may be the same as a storage holder for containing the sample prior to loading the sample into the shipping container. Because the same tray containing the sample vessels will be used in the shipping container, the risk of losing samples during this transfer, missing samples in unregulated thermal environments, etc. is reduced. Since substantially all of the sample vessels in the tray are accumulated in the thermally controlled storage area and then transferred in a single step, the sample is transferred from the thermally controlled storage area to the transport container experience substantially the same thermal exposure at the same time. Because the sample vessels undergo substantially the same exposure, the sample-to-sample variability is reduced due to the different exposure times.

Optionally, the method includes using an individually addressable sample vessel configuration. Optionally, groups of sample vessels, such as those in a common carrier, can be addressed in predefined groups. Alternatively, even sample vessels in a common carrier can be individually addressable. Although this is not a requirement for all embodiments herein, it is particularly useful when loading and/or unloading samples, sample vessels and/or sample holders from the tray.

Some embodiments may use a further container ("outerbox") external to the shipping container to provide further physical protection and/or thermal control capabilities. One or more of the shipping containers can be placed within the outer carton and the combination can be transported from one location to a destination location. By way of non-limiting example, this may be in the form of a corrugated plastic outer box, wherein the outer box is configured to at least partially enclose or enclose the shipping container. In embodiments, the outer box provides thermal insulation for the shipping container enclosed therein. Some embodiments may use a closed cell extruded polystyrene foam carton. Some embodiments of the outer box may be formed from thermoformed sheets. In some embodiments, an outer case may have grips, handles, pads, wheels, latches, levers, and/or for holding, manipulating, securing, securing, transporting, or otherwise controlling the contents of the outer case location, orientation and/or other characteristics of entry. Some embodiments of the outer box may have its own active and/or passive thermal control unit. In embodiments, the outer box provides cooling and thermal insulation for one or more shipping containers enclosed therein. One or more embodiments of the outer box may be configured to house one or more shipping containers. Optionally, the container may also provide additional thermal control to one or more of the shipping containers by providing a thermally regulated environment between the desired temperature ranges. Optionally, the temperature range is between about 1°C and 10°C, optionally between 2°C and 8°C, or between 2°C and 6°C.

In yet another embodiment described herein, a method for thermally characterizing a shipping container after several cooling cycles is provided. By way of non-limiting example, after a certain number of cycles, the shipping container can be thermally characterized to ensure that the container continues to perform within the desired range.

Some embodiments of the container and/or tray may include thermal change indicators. In one non-limiting example, the indicator is integrated on the visible surface of the shipping container, pallet, and/or on the outer carton. In one non-limiting example, thermochromic inks can be used as indicators of thermal changes, especially if the thermal changes result in temperatures outside of the desired range. In one embodiment, the indicator may be configured to discolor the entire case and/or tray. The change can be reversible or irreversible. Optionally, the indicator is positioned only on selected portions of the shipping container and/or pallet, rather than the entire container or pallet.

In one embodiment described herein, there is provided a method comprising collecting a sample of bodily fluid on a surface of a subject, wherein the collected sample is stored in one or more sample vessels; providing a transport container to must receive at least two or more sample vessels upward; and arranging to transport the sample vessels in the transport container from a first position to a second position, wherein each sample vessel reaches the second position and holds the bulk of its non-wicking, non-matrix form of the body fluid sample that can be pipetted from the sample vessel in liquid form, and wherein the amount of sample in each sample vessel does not exceed about 2 ml. In embodiments, the amount of sample in each sample vessel is no more than about 1 ml, or no more than about 500 μL, or no more than about 250 μL, or no more than about 100 μL, or no more than about 50 μL or less.

In another embodiment described herein, there is provided a method for transporting a plurality of sample vessels, the method comprising: providing a container configured to receive at least five or more capillaries each comprising a capillary sample vessels for vascular blood; and arranging for transport of the sample vessels in the transport container from a first position to a second position, wherein each sample vessel arrives at the second position and contains its liquid, non-wicking The majority of capillary blood in the form of capillary blood that can be removed from the sample vessels for further processing, and wherein the amount of capillary blood in each sample vessel does not exceed about 2 ml. In embodiments, the amount of capillary blood in each sample vessel is no more than about 1 ml, or no more than about 500 μL, or no more than about 250 μL, or no more than about 100 μL, or no more than about 50 μL or less.

In another embodiment described herein, there is provided a method for transporting a plurality of sample vessels for containing biological samples, the method comprising: providing a container configured to receive the sample vessels at least five or more of, wherein the amount of sample in each sample vessel does not exceed about 2 ml; and transporting the container and sample vessel from a first location to a second location, wherein each sample vessel arrives at a Two positions and holds the bulk of the biological sample in its liquid, non-wicking form, which can be removed from the sample vessel for further processing. In embodiments, the amount of sample in each sample vessel is no more than about 1 ml, or no more than about 500 μL, or no more than about 250 μL, or no more than about 100 μL, or no more than about 50 μL or less.

In another embodiment described herein, there is provided a method for transporting a plurality of sample vessels containing capillary blood, the method comprising: providing a container having a thermally regulated interior region configured to receive at least five or more sample vessels in a controlled configuration such that at least one cooling surface of the container faces the sample vessel and delivers a controlled release of thermal cooling according to a temperature profile that is maintained during transport the interior region is at about 1 to 10°C without freezing the blood sample; and transporting the container from the first position to the second position, wherein each sample vessel reaches and contains its capillary in a liquid, non-wicking form The majority of the vascular blood, which capillary blood can be removed from the sample vessel for further processing.

In another embodiment described herein, a method for transporting a plurality of blood sample vessels is provided, the method comprising transporting a container having a thermally controlled interior configured to receive ten in an array configuration or more sample vessels, wherein each vessel holds the majority of its blood sample in free-flowing, non-wicking form, and wherein about 1 ml or less of blood is present in each vessel, and each vessel has an interior having at least a partial vacuum atmosphere; wherein sample vessels are held in an array configuration such that the sample vessels are positioned at a controlled distance and orientation from a cooling surface, wherein there is at least one preferential heat transfer from the surface to the sample vessels path.

In another embodiment described herein, there is provided a method for transporting a plurality of sample vessels of less than 1 ml, the method comprising mixing the sample with an anticoagulant prior to transferring the sample to each sample vessel associating each sample vessel with a subject and a desired set of sample assays; and transporting a thermally controlled container containing the plurality of sub-1 ml sample vessels in an array configuration, wherein each vessel Holds a majority of the sample in its free-flowing, non-wicking form, wherein the vessels are arranged such that there are at least two vessels in each vessel associated with each subject, wherein at least a first sample includes a first anticoagulant and the second sample includes a second anticoagulant in the matrix.

In another embodiment described herein, a method is provided, the method comprising: a) placing the plurality of sample vessels in a temperature-controlled transport container, the temperature-controlled transport container comprising being configured with A controlled uniform heat distribution, hyperthermic fusion material in thermal communication with the sample vessel, wherein the material does not cause freezing of the sample fluid in the sample vessel; b) placing the heat distribution shipping container in a in the product cavity defined by at least the top and bottom walls of the transport container; c) placing active cooling means in thermal communication with the cavity, whereby the cooling means are adapted to cool the cavity when activated, the The adsorption cooling device comprises an absorber positioned such that heat generated in the absorber is dissipated outside the product cavity; d) activating the cooling device to initiate cooling of the cavity; e) cooling all the transporting the transport container from the first location to the second location; and f) removing the product from the cavity.

In another embodiment described herein, there is provided a method of transporting a plurality of sub-1 ml sample vessels, the method comprising: transporting a thermally controlled container that houses the plurality of the plurality in an array configuration Sample vessels of less than 1 ml, wherein each vessel holds the majority of its sample in free-flowing, non-wicking form, and wherein the vessels are arranged such that at least two vessels are present in each vessel with each subject In association, wherein at least the first sample includes a first anticoagulant and the second sample includes a second anticoagulant in the matrix.

It should be understood that any of the embodiments herein may be adapted to have one or more of the following features. In one non-limiting example, the body fluid sample is blood. Optionally, the body fluid sample is capillary blood. Optionally, collecting the bodily fluid sample comprises performing at least one puncture of the subject to release the bodily fluid, wherein the puncture is not a venipuncture. Optionally, collecting includes at least one puncture of the subject using at least one microneedle. Optionally, collecting includes at least one puncture of the subject using at least one lancet. Optionally, the puncture is formed by a finger prick. Optionally, the puncture is formed by puncturing the skin on the subject's forearm. Optionally, the puncture is formed by puncturing the skin on the subject's limb. Optionally, the surface is the skin of the subject. Optionally, the shipping container has an interior that is initially at sub-atmospheric pressure. Optionally, the sub-atmospheric pressure is at least a partial vacuum. Optionally, the interior of the shipping container is at sub-atmospheric pressure at least below ambient pressure. Optionally, the sub-atmospheric pressure is selected to provide sufficient force to draw a desired volume of sample into the sample vessel. Optionally, the shipping container contains at least five or more sample vessels. Optionally, the shipping container transports bodily fluid samples from a plurality of different subjects. Optionally, the information associated with each sample vessel determines which tests will be performed on the bodily fluid sample therein. Optionally, the shipping container is placed in another container during shipping. Optionally, the method further comprises pre-treating the sample in the sample vessel prior to transport to the second location.

Optionally, the shipping container has a sample vessel array density of at least about 4 vessels per square inch. Optionally, a cooling surface in the shipping container provides a temperature profile within a desired range for the sample vessel in the vessel. Optionally, the sample vessels are individually addressable. Optionally, the method further comprises using a cooling tray to accommodate the sample vessels in the cooling chamber prior to loading the vessels into the container, and using the same tray to accommodate the sample vessels in the vessels, wherein the The sample is placed in the container along with the cooling tray. Optionally, the sample vessels are arranged such that there are at least two vessels in each vessel with bodily fluid samples from the same subject, wherein at least the first sample includes the first anticoagulant and the second sample includes the matrix. Secondary anticoagulant. Optionally, the fluid sample includes capillary blood for testing by FDA-licensed or FDA-certified assay devices and procedures, or testing by a CLIA-certified laboratory. Optionally, the fluid sample includes blood for testing by FDA-licensed or FDA-certified assay devices and procedures, or testing by a CLIA-certified laboratory. Optionally, the housing of the fusion material providing controlled heat distribution and high heat provides at least one cooling surface facing the vessel. Optionally, a high heat fusion material is embedded in the material used to form the vessel. Optionally, the controlled heat distribution, high heat fusion material is about 30% to 50%. Optionally, the controlled heat distribution, high heat fusion material is about 10% to 30%. Optionally, the method further comprises the housing of a metallic material, the material having a resting temperature below ambient temperature.

Optionally, the method further comprises scanning an information storage unit on each sample at the receiving site and automatically placing the vessel in a cartridge, optionally the method further comprising scanning the receiving site an information storage unit on each sample and automatically placing the vessel in the cartridge, optionally the method further comprises when the sample vessel is in a refrigeration unit prior to shipping and in the shipping container during shipping , the same tray is used to accommodate the sample vessel in the array configuration. Optionally, the method further includes using a tray for containing sample vessels comprising highly thermally conductive materials. Optionally, the tray includes a plurality of grooves shaped to hold the sample vessel holders in a preferential orientation. Optionally, the tray is configured to directly engage the sample vessel holder. Optionally, a tray locking mechanism is used to retain the tray within the vessel, wherein the tray locking mechanism only releases the tray when a magnetic force is applied. Optionally, the method includes maintaining the temperature in the range of 2°C to 8°C during transport. Optionally, the method further includes a temperature control material that is maintained above the freezing point during transport, but at about 10°C or less. Optionally, the method includes using a temperature threshold detection detector to indicate whether the sample vessel has reached a temperature outside a threshold level. Optionally, the method further comprises: scanning the vessels in the tray prior to shipping to determine whether processing steps have been performed on the sample; using a processor to perform or re-perform the steps. Optionally, the method further comprises a single step of loading the one or more sample vessels into the tray and a single step of loading the tray into the shipping container.

Optionally, the shipping container has a first surface configured to define a thermally conductive pathway to a controlled heat distribution, hyperthermic fusion material in the shipping container. Optionally, the first surface is configured to be in direct contact with another surface cooled by the adsorption cooling device. Optionally, the method includes simultaneously scanning the barcodes of the sample vessels in the tray. Optionally, the method includes simultaneously scanning barcodes on the bottom surfaces of the sample vessels in the tray. Optionally, the method includes barcode scanning of the row and column of sample vessels. Optionally, the method includes barcode scanning the bottom surfaces of the rows and columns of sample vessels. Optionally, the method includes transporting the plurality of sample vessels in reverse. Optionally, the method includes transporting a plurality of sample vessels, wherein blood cells and plasma are separated by a barrier material in the sample vessels. Optionally, the method includes opening the shipping container by unlocking and opening the container, wherein at least one hinge holds the two parts together. Optionally, the tray has at least one magnetic contact point for removing the tray from the vessel. Optionally, a computer-controlled end effector is used to load and/or unload sample vessels from the transport container, wherein before, during or after unloading, the reader reads at least one information from the sample vessel or vessels attached to it information in the storage unit. It will be appreciated that although the shipping container is typically used for shipping, it can also be used as a storage container for the trays and/or sample vessels when the shipping container is not used for shipping. Thus, the use of the container is not limited to transportation and does not preclude other suitable uses for any of the embodiments.

In yet another embodiment herein, there is provided a thermally controlled shipping container for transporting a plurality of sample vessels, the shipping container comprising: a container having at least a top wall, a bottom wall, and side walls that collectively define a cavity, wherein at least one of the top, bottom, and side walls includes a phase change material; a frame sized to fit within the cavity, and defining an opening configured to receive a plurality of sample vessels; and having a side wall configured to contact the side wall of the sample vessel, wherein the vessel is arranged such that each patient has at least a first sample comprising a first anticoagulant and a second anticoagulant in a matrix of the second sample.

In another embodiment described herein, there is provided a thermally controlled shipping container for transporting a plurality of sample vessels, the shipping container comprising: a) a bottom container portion including a bottom wall defining a cavity and at least a first a side wall in which the cavity is adapted to contain a product; b) a top container portion comprising a top surface and a floor and adapted to join the bottom container portion to define a product cavity, the top container portion being formed for the vessel The top wall; wherein at least one of the top wall, bottom wall and side wall comprises a phase change material.

In another embodiment described herein, there is provided a thermally controlled transport container for transporting a plurality of sample vessels, the transport container comprising: a) a bottom container portion comprising a bottom wall defining a cavity and at least a first a side wall in which the cavity is adapted to contain product; b) a top container portion comprising a top surface and a bottom surface and adapted to join with the bottom container portion to define a product cavity, the top container portion forming the vessel c) a holder for defining a plurality of sample vessel accommodating spaces to position the sample vessels in a predetermined direction; wherein at least one of the top wall, bottom wall and side wall includes a phase change material .

In another embodiment described herein, there is provided a shipping container for transporting sample vessels, the container comprising: a generally rectangular floor; generally parallel sides projecting from longitudinal edges of the floor ; generally parallel ends protruding from the end edges of the base plate and bridging the sides; coverings that fit over the sides and ends and form generally with the sides and ends and with the base plate is an enclosed space; a sample vessel holder removably coupled to a floor in the interior of the container and configured to define a vessel receiving space. Optionally, the vessel receiving space is configured to receive a vacuum blood collection tube having an internal volume of about 2 ml or less. In at least one embodiment, the vessel receiving space is configured to receive a vessel, such as, but not limited to, a vacuum collection tube having about 1 ml, or less than about 500 μL, or less than about 250 μL, or less than about 100 μL , or an internal volume of less than about 50 μL or less.

In another embodiment described herein, there is provided a thermally controlled transport container for transporting a plurality of sample vessels, the transport container comprising: means for holding the plurality of sample vessels in at least one fixed orientation ; means for thermally controlling the temperature of the sample vessel to be within a desired range of about 0°C to 10°C; wherein the means for containing the plurality of sample vessels is removable from the shipping container of. Optionally, the vessel receiving space is configured to receive a vacuum blood collection tube having an internal volume of about 2 ml or less. In embodiments, the vessel receiving space is configured to receive a vacuum collection tube having an interior of about 1 ml, or less than about 500 μL, or less than about 250 μL, or less than about 100 μL, or less than about 50 μL or less volume.

It should be understood that some embodiments may include a kit comprising a shipping container as set forth in any of the above embodiments. Optionally, the kit includes a shipping container and instructions for its use.

In one embodiment described herein, a method for providing a sample of whole blood and/or a portion thereof from a sender to a recipient is described. The method includes transporting a package including a sample vessel until at least when the whole blood sample and/or portion thereof reaches the recipient, the sample vessel including one or more channels comprising (a) having less than or equal to A fluidized whole blood sample and/or a portion thereof in a volume of about 200 microliters (ul) and (b) one or more for preservation of the whole blood sample and/or portion thereof for analysis A reagent for an analyte, and wherein said depositing results in delivery of said sample vessel to said recipient. By way of non-limiting example, shipping the sample vessel may occur using a parcel delivery service, courier or other shipping service.

In one embodiment described herein, a method for preparing a sample of whole blood for delivery to a sample processing station is described, the method comprising employing a delivery service to deposit a sample of whole blood in fluid form and less than or equal to A sample vessel of approximately 200 ul volume that the delivery service is used to deliver the sample vessel to a sample processing location for processing the whole blood sample. The sample vessel may be prepared by (a) withdrawing the whole blood sample from the subject by means of a capillary channel and (b) placing the whole blood sample in the sample vessel, wherein the whole blood sample Stored in fluid form with one or more reagents contained in the capillary channel and/or the sample vessel.

It should be understood that any of the embodiments herein may be adapted to have one or more of the following features. By way of non-limiting example, the sample in some embodiments may be in a semi-solid or gel state. This can occur after the sample is in the sample vessel. Optionally, the delivery service is a postal delivery service. Optionally, the blood sample is collected from a subject at a point-of-care location. Optionally, the point of care location is the subject's home. Optionally, the point of care location is the location of a healthcare provider.

In another embodiment described herein, a method for processing a whole blood sample comprises receiving a sample vessel from a package delivery service at a processing station, the sample vessel having a whole blood sample of less than or equal to about 200 ul, wherein the sample a vessel receives a whole blood sample in fluid form at the processing station; and performs at least one pre-analytical assay and/or an analytical assay on the fluid condition whole blood sample at the processing station.

It should be understood that any of the embodiments herein may be adapted to have one or more of the following features. By way of non-limiting example, the assay has one or more steps. Optionally, the sample vessel is contained in a housing having one or more environmental control zones. Optionally, the enclosure is adapted to control the humidity of each environmental control zone. Optionally, the enclosure is adapted to control the pressure of each environmental control zone.

In yet another embodiment described herein, a computer-implemented method for queuing a blood sample for processing at a processing location is provided. The method includes (a) identifying, with the aid of a geolocation system having a computer processor, a geographic location of a shipping container with a sample of blood or other body fluid; (b) estimating, with the aid of a computer processor, the shipping container to the processing a delivery time at the location; and (c) providing a notification of preparation for processing the sample at the processing location based on the estimated delivery time.

In yet another embodiment described herein, a method for preparing a whole blood sample for delivery to a sample processing station is described, the method comprising employing a delivery service to hold a sample vessel with a fluidized whole blood sample , the delivery service for delivering the sample vessel to a sample processing location for processing the whole blood sample, wherein the sample vessel by (a) using a device to draw the whole blood sample from the subject and (b) The whole blood sample is placed in the sample vessel for preparation.

Optionally, depositing may include picking up and/or putting down sample vessels. Alternatively, processing may include pre-analytical processing, analytical processing and post-analytical processing of the sample. Alternatively, the delivery service may include a subject's delivery service or a third-party delivery service. Optionally, the whole blood sample is stored in fluid form with one or more reagents contained in the capillary channel or the sample vessel.

In yet another embodiment described herein, a method for processing a whole blood sample at a processing station is provided. The method includes receiving a sample vessel with a whole blood sample at the processing station from a delivery service, wherein the sample vessel draws the whole blood sample from the subject by (a) using a collection device and (b) applying the whole blood sample to the sample vessel. A blood sample is placed in the sample vessel for preparation. The method also includes performing at least one pre-analytical assay or analytical assay on the whole blood sample at the processing station.

It should be understood that any of the embodiments herein may be adapted to have one or more of the following features. By way of non-limiting example, the time for completing the processing is provided by means of a computer processor from the estimated delivery time. Optionally, the method includes queuing the sample vessel for processing after estimating the delivery time of the sample vessel at the processing location. Optionally, the geographic location of the sample vessel is identified by means of a communication network.

In one embodiment described herein, a computer-implemented method for providing an estimated completion time for processing a blood sample is described. The method includes receiving information about a shipping container with a blood sample removed from the subject being transported by the delivery service to a processing station (for sample processing). The method also includes calculating, by means of a computer processor, at the processing station, the position of the blood sample in the processing queue, wherein the prediction is based on (i) the location of blood or other bodily fluid samples from other subjects at the processing station; information on the location in the treatment queue, and (ii) about other sample vessels (with blood samples from other subjects) associated with the sample vessel (with blood samples removed from the subject) geographic location information. The method includes predicting a time for processing the blood sample at the processing station after the sample vessel is delivered by the delivery service to the processing station; and transferring the sample vessel based on the prediction and the estimate The time of delivery to the processing station provides the subject or a healthcare provider associated with the subject with an estimated time for processing a blood sample from the subject, the estimated time from using The point in time measurement at which the delivery service deposited the sample vessel. Optionally, the sample is transported to multiple processing stations. It is to be understood that processing as used herein is to be construed broadly and may include one or more pre-analytical, analytical and/or post-analytical steps.

In yet another embodiment described herein, a computer-implemented method for providing an estimated completion time for processing a blood sample from a subject is described. The method includes receiving information about a shipping container having at least one blood or body fluid sample removed from the subject to be transported by a delivery service to a processing station (for sample processing). The method also includes calculating, by means of a computer processor, at the processing station, the position of the blood sample in a processing queue, wherein the prediction is based on (i) blood samples from other subjects in the processing queue and (ii) the geographic location of other sample vessels (with blood samples from other subjects) associated with the shipping container (with blood samples removed from the subject) Information. The method includes predicting a time for processing the blood sample at the processing station after the shipping container is delivered by the delivery service to the processing station; and transferring the shipping container based on the prediction and the estimated time The time of delivery to the processing station at which one or more resources are allocated for processing the blood sample after delivery of the blood sample to the processing station.

It should be understood that any of the embodiments herein may be adapted to have one or more of the following features. By way of non-limiting example, the shipping container has an information storage unit that allows the shipping container to be identified by the delivery service and/or the processing location. Optionally, the information storage unit is a radio frequency identification (RFID) tag. Optionally, the information storage unit is a barcode. Optionally, the information storage unit is a microchip. Optionally, the transport container includes one or more of the temperature for collecting the bodily fluid sample (eg, blood sample), the pressure of the sample vessel, the pH of the sample, the turbidity of the sample, the A sensor for one or more of the viscosity of the sample or other properties of the sample. Optionally, the processing location processes the collected bodily fluid samples on demand. Optionally, the shipping container includes a geolocation device for providing the location of the sample vessel. Optionally, the anticoagulant is selected from heparin, EDTA, anticoagulant or other additives. Optionally, the transport container (wherein the container receiving space is configured to receive a vacuum blood collection tube) is configured to receive a vacuum sample collection tube having a vacuum of at most about 30%, or a vacuum of at most about 30%. 40% vacuum, or up to about 50% vacuum, or up to about 60% vacuum, or up to about 70% vacuum, or up to about 80% vacuum, or up to about 90% vacuum partial vacuum.

In the embodiments described herein involving the first vessel and the second vessel, in certain embodiments, the internal volumes of the first vessel and the second vessel are each 1000 microliters, 750 microliters, 500 microliters liters, 400 microliters, 300 microliters, 250 microliters, 200 microliters, 150 microliters, 100 microliters, 90 microliters, 80 microliters, 70 microliters, 60 microliters, 50 microliters, 40 microliters, 30µl, 25µl, 20µl, 15µl, 10µl, 9µl, 8µl, 7µl, 6µl, 5µl, 4µl, 3µl, 2µl liters or less. In the embodiments described herein involving the first vessel and the second vessel, in certain embodiments, neither the first vessel nor the second vessel has an internal volume exceeding 1000 microliters, 750 microliters, 500 microliters microliters, 400 microliters, 300 microliters, 250 microliters, 200 microliters, 150 microliters, 100 microliters, 90 microliters, 80 microliters, 70 microliters, 60 microliters, 50 microliters, 40 microliters , 30µl, 25µl, 20µl, 15µl, 10µl, 9µl, 8µl, 7µl, 6µl, 5µl, 4µl, 3µl or 2 microliters. In embodiments described herein involving one or more vessels, in certain embodiments, each of the one or more vessels has an internal volume of 1000 microliters, 750 microliters, 500 microliters , 400 microliters, 300 microliters, 250 microliters, 200 microliters, 150 microliters, 100 microliters, 90 microliters, 80 microliters, 70 microliters, 60 microliters, 50 microliters, 40 microliters, 30 microliters, 25 microliters, 20 microliters, 15 microliters, 10 microliters, 9 microliters, 8 microliters, 7 microliters, 6 microliters, 5 microliters, 4 microliters, 3 microliters, 2 microliters or less. In embodiments described herein involving one or more vessels, in certain embodiments, none of the one or more vessels has an internal volume exceeding 1000 microliters, 750 microliters, 500 microliters, 400 microliters microliters, 300 microliters, 250 microliters, 200 microliters, 150 microliters, 100 microliters, 90 microliters, 80 microliters, 70 microliters, 60 microliters, 50 microliters, 40 microliters, 30 microliters , 25 microliters, 20 microliters, 15 microliters, 10 microliters, 9 microliters, 8 microliters, 7 microliters, 6 microliters, 5 microliters, 4 microliters, 3 microliters or 2 microliters.

In embodiments described herein involving a first vessel and a second vessel, each vessel contains a portion of the small volume of bodily fluid sample, in certain embodiments, neither the first vessel nor the second vessel contains With greater than 500 microliters, 400 microliters, 300 microliters, 250 microliters, 200 microliters, 150 microliters, 100 microliters, 90 microliters, 80 microliters, 70 microliters, 60 microliters, 50 microliters, 40µl, 30µl, 25µl, 20µl, 15µl, 10µl, 9µl, 8µl, 7µl, 6µl, 5µl, 4µl, 3µl A portion of the small volume body fluid sample in a volume of 1 or 2 μl.

In the embodiments described herein involving vessels containing small volumes of bodily fluid samples, in certain embodiments, the volume of the small volumes of bodily fluid samples in the vessel is no greater than 500 microliters, 400 microliters, 300 microliters , 250µl, 200µl, 150µl, 100µl, 90µl, 80µl, 70µl, 60µl, 50µl, 40µl, 30µl, 25µl, 20 microliters, 15 microliters, 10 microliters, 9 microliters, 8 microliters, 7 microliters, 6 microliters, 5 microliters, 4 microliters, 3 microliters or 2 microliters.

In the embodiments described herein involving one or more vessels containing a bodily fluid sample, in certain embodiments at least one of the one or more vessels contains at least 99% of the interior volume that fills the vessel %, 98%, 97%, 96%, 95%, 90%, 85%, 80%, 75%, 70%, 60%, 50%, 40%, 3%, 20%, 10%, or 5% body fluid samples. In embodiments described herein involving one or more vessels containing a bodily fluid sample, in certain embodiments, all of the one or more vessels contain at least a portion of the interior volume that fills the vessel. 99%, 98%, 97%, 96%, 95%, 90%, 85%, 80%, 75%, 70%, 60%, 50%, 40%, 3%, 20%, 10% or 5% body fluid samples.

In embodiments described herein involving a sample collection site and a sample reception site, in embodiments, the sample collection site and the sample reception site may be in the same room, building, campus, or group of buildings. In embodiments described herein involving sample collection sites and sample reception sites, in embodiments, the sample collection sites and sample reception sites may be in different rooms, buildings, campuses, or groups of buildings. In embodiments, the sample collection site and the sample receiving site may be separated by at least 1 meter, 5 meters, 10 meters, 50 meters, 100 meters, 500 meters, 1 kilometer, 5 kilometers, 10 kilometers, 15 kilometers, 20 kilometers km, 30 km, 50 km, 100 km or 500 km. In embodiments, the sample collection site and the sample receiving site may be separated by no more than 5 meters, 10 meters, 50 meters, 100 meters, 500 meters, 1 kilometer, 5 kilometers, 10 kilometers, 15 kilometers, 20 kilometers , 30 km, 50 km, 100 km, 500 km or 1000 km. In embodiments, the sample collection site and the sample receiving site may be separated by at least 1 meter, 5 meters, 10 meters, 50 meters, 100 meters, 500 meters, 1 kilometer, 5 kilometers, 10 kilometers, 15 kilometers, 20 kilometers kilometers, 30 kilometers, 50 kilometers, 100 kilometers, or 500 kilometers, but not more than 5 meters, 10 meters, 50 meters, 100 meters, 500 meters, 1 kilometer, 5 kilometers, 10 kilometers, 15 kilometers Kilometers, 20 kilometers, 30 kilometers, 50 kilometers, 100 kilometers, 500 kilometers, or 1000 kilometers. In an embodiment, the first location described herein can be a sample collection site, and the second location described herein can be a sample receiving site.

In embodiments described herein involving vessels that contain at least a portion of a small volume of bodily fluid sample transported from a sample collection site to a sample receiving site, in embodiments, the bodily fluid sample is in the vessel's Can remain in liquid form during transport. In embodiments described herein involving two or more vessels, each vessel containing at least a portion of a small volume of bodily fluid sample transported from a sample collection site to a sample receiving site, in embodiments, each vessel The bodily fluid sample in can remain in liquid form during transport of the vessel.

In embodiments described herein involving transport of one or more vessels from a sample collection site to a sample receiving site, in embodiments, the one or more vessels may be transported in a shipping container. In embodiments described herein involving one or more vessels transported in a shipping container, in embodiments, the one or more vessels may be positioned in the shipping container in an array, and when retrieved from the shipping container When viewed from top to bottom, the array may contain at least 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 20 per square inch , 25, 30, 35, 40, 50 or 100 vessels.

In embodiments described herein that relate to transporting one or more vessels in a shipping container, in embodiments, the shipping container may contain samples from at least 1, 2, 3, 4, 5, Body fluid samples from 6, 7, 8, 9, 10, 15, 20, 25, 30, 35, 40, 50 or 100 different subjects.

In embodiments described herein that relate to a vessel comprising at least a portion of a bodily fluid sample, in embodiments, the vessel may contain an anticoagulant. In embodiments involving two or more vessels each containing a portion of a body fluid sample from a subject, in embodiments at least one or all of the vessels may contain an anticoagulant. In embodiments, when two or more vessels each containing a portion of a body fluid sample from a subject also each contain an anticoagulant, the vessels may contain the same anticoagulant or different anticoagulants. The anticoagulant in the vessel can be, for example, heparin or EDTA.

In the methods described herein involving transport of a bodily fluid sample in one or more vessels from a sample collection site to a sample receiving site, in embodiments, the bodily fluid sample can be obtained from the subject at the time of obtaining the No more than 48 hours, 36 hours, 24 hours, 16 hours, 12 hours, 8 hours, 7 hours, 6 hours, 5 hours, 4 hours, 3 hours, 2 hours, 60 minutes, 45 minutes, 30 minutes, 20 minutes, 15 minutes, 10 minutes or 5 minutes to the sample receiving location.

In the methods described herein involving transporting at least one vessel from a sample collection site to a sample receiving site, in embodiments, the method may further comprise centrifuging the vessel prior to transporting it. In the methods described herein involving transporting a plurality of vessels from a sample collection site to a sample receiving site, in embodiments, the method may further comprise centrifuging the plurality of vessels prior to transporting them.

In the methods described herein involving transporting at least a first vessel from a sample collection site to a sample receiving site, in embodiments, at the sample receiving site and prior to removing the sample from the first vessel, The first vessel was inserted into a sample processing device containing an automated fluid processing device. In the methods described herein involving transporting at least a first vessel and a second vessel from a sample collection site to a sample receiving site, in embodiments, at the sample receiving site and during removal from the first vessel Before taking the sample, the first and second vessels were inserted into a sample processing device containing an automated fluid processing device. In embodiments, when a vessel containing a sample is inserted into a sample processing device comprising an automated fluid handling device, the sample can be removed from the vessel by the automated fluid handling device. In an embodiment, prior to inserting a vessel containing a sample into a sample processing device comprising an automated fluid processing device, the vessel is inserted into a cartridge, and then the cartridge is inserted into the sample processing device . The cartridge can hold any number of sample-containing vessels, such as at least 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 20 , 25, 50 or 100 vessels. The cartridge may also contain one or more reagents for performing one or more laboratory tests on the sample. In embodiments, a cartridge may contain all reagents necessary to perform all assays to be performed with one or more samples in the cartridge.

In embodiments, a portion of the portion of the body fluid sample in the vessel may be any amount. For example, in an embodiment, a portion of the portion of the body fluid sample in the first vessel may be a portion of the first vessel original sample or a portion of the first vessel diluted sample. In another example, in an embodiment, a portion of the portion of the body fluid sample in the second vessel may be a portion of the second vessel original sample or a portion of the second vessel diluted sample.

In embodiments provided herein involving the transport of one or more vessels, each vessel containing at least a portion of a bodily fluid sample from a sample collection site to a sample receiving site, in embodiments, the at least one of the vessels may be A portion of the portion of the body fluid sample performs one or more steps of any number of laboratory tests. For example, in embodiments, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 20, 25, 30, 40, 50 may be performed on a portion of the at least partial body fluid sample , 60, 70, 80, 90, 100, 200, 300, 400, 500 or 1000 or more steps of one or more different laboratory tests. Various different laboratory tests may use a single portion of the body fluid sample, or in embodiments, more than one different laboratory test may be performed with a particular portion of the body fluid sample. The different laboratory tests can be of the same type, of different types, or a mixture of the same and different types. The one or more vessels may be, for example, the first vessel, or the first vessel and the second vessel.

In embodiments, when bodily fluid samples from a subject transported according to the systems or methods provided herein are used for more than one laboratory test, each laboratory test may use no more than 50, 40, 30, 25, 20, 15, 10, 9, 8, 7, 6, 5, 4, 3, 2, 1, 0.5, 0.1, 0.05, or 0.01 equivalents of pure body fluid samples (eg, undiluted whole blood, saliva or urine).

In embodiments provided herein involving obtaining a plurality of vessels at a sample collection site, the plurality of vessels collectively contain a small volume of bodily fluid sample from a subject, in embodiments, in all vessels of the plurality of vessels The total volume of the small volume body fluid sample obtained from the subject in between may be no greater than 500 microliters, 400 microliters, 300 microliters, 250 microliters, 200 microliters, 150 microliters, 100 microliters liters, 90 microliters, 80 microliters, 70 microliters, 60 microliters, 50 microliters, 40 microliters, 30 microliters, 25 microliters, 20 microliters, 15 microliters, 10 microliters, 9 microliters, 8 microliters, 7 microliters, 6 microliters, 5 microliters, 4 microliters, 3 microliters or 2 microliters.

In the embodiments provided herein involving the transport of a vessel containing at least a portion of a bodily fluid sample from a sample collection site to a sample receiving site, the original sample is removed from the vessel at the sample receiving site, and then removed from the original sample A diluted sample is generated, and in embodiments, the dilution may be generated stepwise or continuously. In embodiments, the diluted sample may have no more than 1000 microliters, 900 microliters, 800 microliters, 700 microliters, 600 microliters, 500 microliters, 400 microliters, 300 microliters, 250 microliters, 200 microliters microliters, 150 microliters, 100 microliters, 90 microliters, 80 microliters, 70 microliters, 60 microliters, 50 microliters, 40 microliters, 30 microliters, 25 microliters, 20 microliters, 15 microliters , 10 microliters, 9 microliters, 8 microliters, 7 microliters, 6 microliters, 5 microliters, 4 microliters, 3 microliters or 2 microliters total volume. In embodiments, the diluted sample may be diluted at least 2-fold, 3-fold, 4-fold, 5-fold, 6-fold, 7-fold, 8-fold, 9-fold, 10-fold, 15-fold, 20-fold relative to the original sample times, 50 times, 100 times, 200 times, 300 times, 400 times, 500 times, 1000 times, 5,000 times, 10,000 times, 50,000 times, or 100,000 times.

In the embodiments provided herein involving transport of at least a first vessel and a second vessel from a sample collection site to a sample receiving site, the first and second vessels each contain a small volume obtained from the subject A portion of the bodily fluid sample, in embodiments, at the sample receiving site, a first vessel raw sample can be removed from the first vessel and a second vessel raw sample can be removed from the second vessel. A first vessel diluted sample may be generated from the first vessel original sample. A second vessel diluted sample can be generated from the second vessel original sample. The first vessel diluted sample and the second vessel diluted sample may have the same or different volumes and dilutions. In embodiments, a plurality of different diluted samples can be generated from one or both of the first vessel raw sample or the second vessel raw sample. The different diluted samples can be used for one or more different laboratory tests, which can be of different types. In embodiments, the first vessel diluted sample may be diluted at least 2 times, 3 times, 4 times, 5 times, 6 times, 7 times, 8 times, 9 times, 10 times, 15 times, 20 times, 50 times, 100 times, 200 times, 300 times, 400 times, 500 times, 1000 times, 5,000 times, 10,000 times, 50,000 times, or 100,000 times, and have no more than 1000 microliters, 900 microliters , 800 microliters, 700 microliters, 600 microliters, 500 microliters, 400 microliters, 300 microliters, 250 microliters, 200 microliters, 150 microliters, 100 microliters, 90 microliters, 80 microliters, 70 microliters, 60 microliters, 50 microliters, 40 microliters, 30 microliters, 25 microliters, 20 microliters, 15 microliters, 10 microliters, 9 microliters, 8 microliters, 7 microliters, 6 microliters , 5 microliters, 4 microliters, 3 microliters or 2 microliters total volume, and the second vessel diluted sample can be diluted at least 2 times, 3 times, 4 times, 5 times relative to the second vessel original sample , 6 times, 7 times, 8 times, 9 times, 10 times, 15 times, 20 times, 50 times, 100 times, 200 times, 300 times, 400 times, 500 times, 1000 times, 5,000 times, 10,000 times, 50,000 times times or 100,000 times and has no more than 1000 microliters, 900 microliters, 800 microliters, 700 microliters, 600 microliters, 500 microliters, 400 microliters, 300 microliters, 250 microliters, 200 microliters, 150 microliters, 100 microliters, 90 microliters, 80 microliters, 70 microliters, 60 microliters, 50 microliters, 40 microliters, 30 microliters, 25 microliters, 20 microliters, 15 microliters, 10 microliters , 9 microliters, 8 microliters, 7 microliters, 6 microliters, 5 microliters, 4 microliters, 3 microliters or 2 microliters total volume.

In embodiments provided herein involving obtaining a vessel at a sample collection site, the vessel contains a small volume of bodily fluid sample obtained from a subject, in embodiments, the volume of the small volume of bodily fluid sample in the vessel Can be no more than 500 microliters, 400 microliters, 300 microliters, 250 microliters, 200 microliters, 150 microliters, 100 microliters, 90 microliters, 80 microliters, 70 microliters, 60 microliters, 50 microliters , 40 microliters, 30 microliters, 25 microliters, 20 microliters, 15 microliters, 10 microliters, 9 microliters, 8 microliters, 7 microliters, 6 microliters, 5 microliters, 4 microliters, 3 microliters microliters or 2 microliters.

In the embodiments provided herein involving obtaining a vessel at a sample collection site and transporting the vessel from the sample collection site to the sample receiving site, the vessel contains a small volume of bodily fluid sample obtained from a subject, in embodiments , the small volume of body fluid sample can be divided into any number of parts, such as 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 20, 25, 30, 40, 50, 60, 70, 80, 90, 100, 200, 300, 400, 500 or 1000 different parts. The fractions can be diluted to the same or different amounts and can be used, for example, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 20, 25, 30, 40, 50 , 60, 70, 80, 90, 100, 200, 300, 400, 500 or 1000 or more different laboratory tests.

In embodiments provided herein involving obtaining at least one vessel containing at least a portion of a small volume of bodily fluid sample from a subject at a sample collection site, in embodiments, the obtaining step may comprise obtaining from the subject Alternatively (eg, from a finger stick or venous blood draw) the small volume of bodily fluid sample is collected.

In the embodiments provided herein that relate to performing at least a portion of a laboratory test in an assay unit, in an embodiment, the assay unit may be movable, such as by a fluid handling device. In embodiments comprising two or more assay units, in embodiments, the assay units may be independently movable.

In the embodiments provided herein involving the transport of one or more vessels containing a bodily fluid sample, in some embodiments, the vessel may have any of the characteristics of the vessels described herein or other vessels suitable for storing bodily fluids. In some embodiments, the vessel can be loaded with a bodily fluid sample by any of the devices or methods provided herein, or by other suitable techniques for loading vessels with small internal volumes. For example, in certain embodiments, vessels to be transported in accordance with the systems or methods provided herein may be loaded with sample through a syringe or pipette tip.

Optionally, at least one embodiment of the sample collection device herein can separate a single blood sample into different vessels for different pre-analytical processing. This can be accomplished through fluid passages in the device and/or through different inlet ports on the device.

This Summary is provided to introduce a selection of concepts in a simplified form that are further described below in the Detailed Description. This Summary is not intended to identify key features or essential features of the claimed subject matter, nor is it intended to be used to limit the scope of the claimed subject matter.

incorporated by reference

All publications, patents and patent applications mentioned in this specification are hereby incorporated by reference to the same extent as if each individual publication, patent or patent application was specifically and individually indicated to be incorporated by reference.

Description of drawings

1A-1B illustrate perspective views of a sample collection device according to one embodiment as described herein.

2A-2C illustrate perspective views of a sample collection device without a cap, according to one embodiment as described herein.

3A-3B illustrate side and cross-sectional views of a sample collection device according to one embodiment as described herein.

4A-4B illustrate side and cross-sectional views of a sample collection device according to one embodiment as described herein.

5A-5B illustrate perspective views of a sample collection device according to another embodiment as described herein.

6A-6B illustrate side views of a sample collection device according to one embodiment as described herein.

7A-8B illustrate side and cross-sectional views of a sample collection device according to one embodiment as described herein.

9A-9C illustrate side cross-sectional views of a sample collection device at various stages of use, according to one embodiment as described herein.

10A-10B illustrate perspective views of a sample collection device according to one embodiment as described herein.

11A-11Z illustrate views of various examples of sample collection devices according to embodiments as described herein.

Figure 12 shows a schematic diagram of the tip portion of the sleeve and the balance of associated forces associated with one embodiment as described herein.

Figures 13A-13D illustrate views of various collection devices with upward facing collection positions, according to embodiments as described herein.

Figures 14-15 show various views of a collection device having a single collection location, according to one embodiment as described herein.

16-17 illustrate perspective and end views of a sample collection device using a vessel with a marker, according to one embodiment as described herein.

18A-18G illustrate various views of a sample vessel according to embodiments as described herein.

Figures 19A-19C show views of various embodiments of the front end of the sample collection device.

20-21 illustrate various embodiments of a sample collection device with an integrated tissue penetrating member.

Figure 22 shows a perspective view of a collection device for use with a blood vessel or other tissue penetrator and a sample collector in accordance with embodiments described herein.

Figures 23-28 show various views of a collection device for use with various sample collectors in accordance with embodiments described herein.

29A-29C show schematic diagrams of various embodiments as described herein.

30-31 show schematic diagrams of methods according to embodiments described herein.

Figure 32 shows a schematic diagram of one embodiment of the system described herein.

Figures 33-37 illustrate yet another embodiment of the collection device described herein.

38A-39 illustrate various views of a thermally controlled shipping container transport device in accordance with at least one embodiment described herein.

40A-40C show schematic diagrams of various embodiments described herein.

Figure 41 shows a perspective view of a portion of a shipping container having a plurality of sample vessels therein, according to at least one embodiment described herein.

42 is an exploded perspective view of a portion of a shipping container having a plurality of sample vessels therein, according to at least one embodiment described herein.

Figure 43 shows a perspective view of a shipping container according to yet another embodiment described herein.

Figure 44 shows a schematic diagram of the sample collection and shipping process according to one embodiment described herein.

Figure 45 shows a schematic diagram of a sample collection and shipping process according to yet another embodiment described herein.

Figure 46 shows a sample collection device according to one embodiment described herein.

Figure 47 shows a schematic diagram of a system for unloading sample vessels from shipping containers, according to one embodiment described herein.

Figure 48 is a graph showing the stability of analytes in samples in vessels provided herein.

Figures 49-51 illustrate one non-limiting example of detection in accordance with at least one embodiment described herein.

Figures 52-55 illustrate various views of devices and systems according to embodiments herein.

56-59 illustrate various views of a sample transport device according to at least some embodiments herein.

Detailed ways

It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory only and are not restrictive of the invention as claimed. It may be noted that, as used in this specification and the appended claims, the singular forms "a," "an," and "the" include plural referents unless the context clearly dictates otherwise. Thus, for example, reference to "a material" may include a mixture of materials, reference to "a compound" may include multiple compounds, and the like. References cited herein are hereby incorporated by reference in their entirety, except to the extent that they conflict with the teachings expressly set forth in this specification.

In this specification and in the claims that follow, reference will be made to several terms which shall be defined as having the following meanings:

"Optional" or "optionally" means that the subsequently described event may or may not occur, such that the description includes instances where the event occurs and instances where it does not. For example, if a device optionally includes a feature for a sample collection hole, this means that the sample collection hole may or may not be present, and thus, the description includes both configurations in which the device is provided with the sample collection hole and in which the sample collection hole is not present The structure of the sample collection well.

As used herein, the term "substantially" means more than a minimal or insignificant amount; and "substantially" means more than a minimal or insignificant amount. Thus, by way of example, the phrase "substantially different" as used herein denotes a sufficiently high degree of difference between two values that one of ordinary skill in the art would consider the difference between the two values to be attributable to the stated Values are statistically significant within the context of the property being measured. Thus, as a function of the reference or comparison value, the difference between two values substantially different from each other is typically greater than about 10%, and may be greater than about 20%, preferably greater than about 30%, preferably greater than about 40%, preferably greater than about 50%.

As used herein, a "sample" may be, but is not limited to, a blood sample or a portion of a blood sample, and may be of any suitable size or volume, and preferably is a small size or volume. In some embodiments of the assays and methods disclosed herein, measurements can be made using a small volume of blood sample or a small volume fraction of no more than a blood sample, wherein the small volume includes no more than about 5 mL; alternatively includes no more than about 3 mL; or includes or include no more than about 2 mL; or include no more than about 1 mL; or include no more than about 500 μL; or include no more than about 250 μL; or include no more than about 100 μL; or include no more than about 75 μL; or include no more than about 50 μL; or includes not more than about 25 μL; or includes not more than about 20 μL; or includes not more than about 15 μL; or includes not more than about 10 μL; or includes not more than about 8 μL; or includes not more than about 6 μL; or includes not more than about 4 μL; or includes not more than about 3 μL; or includes not more than about 2 μL; or includes not more than about 1 μL; or includes not more than about 0.8 μL; or includes not more than about 0.5 μL; or includes not more than about 0.2 μL; or includes not more than about 0.1 μL; or includes not more than about 0.05 μL; or includes not more than about 0.01 μL.

As used herein, the term "point of service location" may include a location where a subject may receive services (eg, testing, monitoring, treatment, diagnosis, instruction, sample collection, ID verification, medical services, non-medical services, etc.), and may include, but is not limited to, the subject's residence, the subject's workplace, the location of a healthcare provider (eg, a doctor), a hospital, emergency room, operating room, clinic, healthcare professional's office, laboratory , retailers [eg pharmacies (eg, retail pharmacies, clinical pharmacies, hospital pharmacies), pharmacies, supermarkets, grocery stores, etc.], transportation (eg, cars, boats, trucks, buses, airplanes, motorcycles, ambulances) , mobile units, fire trucks/firetrucks, emergency vehicles, law enforcement vehicles, police vehicles, or other vehicles configured to transport subjects from one point to another, etc.), itinerant healthcare units, mobile units, schools, Day care centers, security screening sites, combat sites, medical assisted living residences, government offices, office buildings, tents, bodily fluid sample collection sites (e.g., blood collection centers), at or near entrances to sites where subjects may wish to enter A location, a location at or near a device that the subject may wish to access (eg, the location of a computer if the subject wishes to access the computer), the location where the sample processing device receives the sample, or any other location described elsewhere herein Service point location.

As used herein, a "body fluid" can be any fluid obtained or obtainable from a subject. The bodily fluid can be, for example, blood, urine, saliva, tears, sweat, bodily secretions, bodily excretions, or any other fluid derived from or obtained from the subject. Specifically, bodily fluids include, but are not limited to, blood, serum, plasma, bone marrow, saliva, urine, gastric fluid, spinal fluid, tears, feces, mucus, sweat, ear wax, oil, glandular secretions, cerebrospinal fluid, semen, vaginal fluid, source Interstitial fluid, ocular fluid, fetal fluid, amniotic fluid, umbilical cord blood, lymph fluid, cavity fluid, sputum, pus, meconium, breast milk and/or other secretions or excretions from tumor tissue.

As used herein, a "body fluid sample collector" or any other collection mechanism may be disposable. For example, bodily fluid collectors can be used once and thrown away. The bodily fluid collector may have one or more disposable components. Alternatively, the body fluid collector may be reusable. The body fluid collector can be reused any number of times. In some cases, the bodily fluid collector includes both reusable and disposable components.

As used herein, a "sample collection unit" and/or any other portion of the device may be capable of receiving a single type of sample or multiple types of samples. For example, the sample collection unit may be capable of receiving two different types of body fluids (e.g., blood, tears). In another example, the sample collection unit may be capable of receiving two different types of biological samples (e.g., urine samples, stool samples). Various types of samples may or may not be fluid, solid and/or semi-solid. For example, the sample collection unit may be capable of receiving one or more, two or more, or three or more of bodily fluids, secretions and/or tissue samples.

As used herein, "non-wicking, non-matrix form" means that a liquid or suspension is not absorbed or drawn into it by fabrics, meshes, fibrous pads, absorbent materials, absorbent structures, permeable networks of fibers, etc. Meshes, fibrous mats, absorbent materials, absorbent structures, osmotic networks of fibers that alter the form of a liquid or suspension or trap components of the sample therein to such an extent that the integrity of the sample in liquid form is altered and cannot remain Extract samples in liquid form for sample analysis while maintaining sample integrity.

As used herein, the term "sample processing system" refers to a device or system configured to assist in the imaging, detection, positioning, repositioning, retention, ingestion and storage of a sample. In one example, the robot with pipetting capabilities is a sample handling system. In another example, a pipette that may or may not have (other) robotic capabilities is a sample processing system. The sample processed by the sample processing system may or may not include fluid. The sample processing system may be capable of transporting bodily fluids, secretions or tissue. The sample processing system may be capable of transporting one or more substances within the device that are not necessarily a sample. For example, the sample processing system may be capable of delivering powders that can react with one or more samples. In some cases, the sample processing system is a fluid processing system. Fluid handling systems may include various types of pumps and valves or pipettes, which may include, but are not limited to, volumetric pipettes, vented pipettes, and aspiration pipettes. The sample processing system may transport samples or other substances with the aid of the robots described elsewhere herein.

As used herein, the term "health care provider" refers to a physician or other health care professional who provides medical treatment and/or medical advice to a subject. A healthcare professional may include a person or entity associated with a healthcare system. Examples of healthcare professionals may include doctors (including general practitioners and specialists), surgeons, dentists, audiologists, speech pathologists, physician assistants, nurses, midwives, pharmacists/pharmacists, nutritionists, therapists , psychologists, chiropractors, clinicians, physical therapists, phlebotomists, occupational therapists, optometrists, emergency medical technicians, paramedics, medical laboratory technicians, medical prosthetics technicians, radiology technologists, social workers, and Numerous other human resources trained to provide some types of health care services. Healthcare professionals may or may not be qualified to prescribe. Health care professionals may work in or be affiliated with hospitals, health care locations and other service delivery sites, or they may also work in academic training, research and administrative institutions. Some health care professionals may provide care and treatment to patients in private or public premises, community centers, or gathering places or mobile units. Community health workers can work outside of formal health care settings. Healthcare service administrators, medical records and health information technicians, and other support staff can also be healthcare professionals or affiliated with healthcare providers. A health care professional can be an individual or agency that provides preventive, curative, advocacy, or rehabilitative health care to an individual, family, or community.

In some embodiments, the healthcare professional may already be familiar with or have communicated with the subject. Subjects may be patients of healthcare professionals. In some cases, a health care professional may have asked the subject to perform a clinical test as ordered. A healthcare professional may have instructed or advised the subject to undergo clinical testing at the service store location or by a laboratory. In one example, the healthcare professional may be the subject's primary care physician. The healthcare professional may be any type of physician of the subject (including general practitioners, referred practitioners, or optionally the patient's own physician selected and contacted through telehealth services, and/or specialties) physician). A healthcare professional can be a healthcare professional.

As used herein, the term "rack" refers to a frame or enclosure for mounting multiple modules. The rack is configured to allow modules to be fastened to or engaged with the rack. In some cases, the dimensions of the rack are standardized. In one example, the spacing between modules is normalized to at least about 0.5 inches, or 1 inch, or 2 inches, or 3 inches, or 4 inches, or 5 inches, or 6 inches, or 7 inches, or 8 inches, or 9 inches, or 10 inches, or 11 inches, or multiples of 12 inches.

The term "cell" as used in the context of a biological sample includes samples that are substantially similar in size to a single cell, including but not limited to vesicles (such as liposomes), cells, virions, and cells such as beads, nanoparticles or microparticles. A substance that binds small particles such as balls. Properties include, but are not limited to, size; shape; temporal and dynamic changes such as cell movement or proliferation; granularity; whether cell membranes are intact; internal cellular inclusions, including but not limited to protein inclusions, protein modifications, nucleic acid inclusions, Nucleic acid modifications, organelle inclusions, nuclear structure, nuclear inclusions, internal cellular structures, contents of internal vesicles, ion concentrations, and the presence of other small molecules such as steroids or drugs; and cell surface (cell membrane) and cell wall) markers, including proteins, lipids, carbohydrates and their modifications.

As used herein, "sample" refers to the entire original sample or any portion thereof, unless the context clearly dictates otherwise.

The present invention provides systems and methods for multipurpose analysis of samples or health parameters. A sample can be collected and one or more sample preparation steps, assay steps, and/or detection steps can be performed on the device. The various aspects of the invention described herein may be applied to any of the specific applications, systems and devices set forth below. The present invention may be implemented as a stand-alone system or method, or as part of an integrated system, such as in systems involving point-of-service healthcare. In some embodiments, the system may include externally directed imaging techniques such as ultrasound or MRI, or be integrated with peripherals for integrated imaging and other health monitoring or services. It should be understood that various aspects of the invention may be understood and practiced individually, collectively or in combination with each other.

Referring to Figures 1A-1B, one embodiment of a sample collection device 100 will now be described. In this non-limiting example, the sample collection device 100 may include a collection device body 120, a holder 130, and a base 140. In some cases, cap 110 may optionally be provided. In one embodiment, the cap can be used to protect the opening, keep it clean, and to cover the bloody tip after collection. Optionally or alternatively, the cap may also be used to limit the flow rate during transfer of the sample fluid into the sample vessel by controlling the amount of discharge provided to the capillary. Some embodiments may include a vent hole passage in the cap (either permanently open or operably closed), while other embodiments do not. Optionally, the collection device body 120 may include a first portion of the device 100 having one or more collection passages (such as, but not limited to, collection channels 122a, 122b) therein, which first portion may be capable of receiving sample B. FIG. 1A shows that Sample B only partially fills the channels 122a, 122b, it should be understood that while partial filling is not excluded in some alternative embodiments, in most embodiments, when the filling process is complete, all The channel will be completely filled with sample B. In this embodiment, the base 140 may have one or more fill indicators 142a, 142b, such as, but not limited to, optical indicators, which may provide an indication of whether the sample has reached one or more of the fill indicators housed in the base. instructions for a utensil. It should be understood that although the indication may be by means of a visual indication, other indication methods such as audio, vibration or other indication methods may be used in place of or in combination with the indication methods described. The indicator may be located on at least one of the vessels. Variations and substitutions are possible for the embodiments described herein, and no single embodiment should be construed as encompassing the entire invention.

Although not shown for ease of illustration, stent 130 may also include one or more fill indicators that show whether a desired fill level has been achieved in channels 122a and 122b. This may be in place of or in addition to the fill indicators 142a, 142b. Of course, the one or more passage fill indicators may be positioned on different components and are not limited to the bracket 130. It should be understood that although such fill level indication in one or more of channels 122a and 122b may be by means of a visual indication, other indication methods such as audio, vibration or other indication methods may be used in place of the described Indicate method or in combination with it. The indicator may be located on at least one of the collection passages. Optionally, indicators are located on all collection paths.

In this embodiment, the bracket 130 may be used to couple the main body 120 and the base 140 to form an integrated device. It should be understood that although device body 120, bracket 130 and base 140 are illustrated as separate components, one or more of these components may be integrally formed to simplify manufacturing, and such integration is not precluded herein.

In some embodiments herein, a cap 110 may optionally be provided. In one non-limiting example, the cap may fit over a portion of the collection device body 120. The cap 110 may be removable from the collection device body 120 . In some cases, cap 110 may be completely detachable from collection device body 120, or may remain partially attached to the collection device body, such as, but not limited to, hinged or otherwise attached to the collection device. The cap 110 may cover a portion of the collection device body 120 in which the exposed end of the one or more channels is contained. When the cap is in place, the cap 110 can prevent materials such as air, fluid or particulates from entering the passageway within the body of the device. Alternatively, cap 110 may be attached to collection body 120 using any technique known in the art or hereafter developed. For example, the cap may snap fit, screw on, friction fit, clip on, have a magnetic portion, tie to, utilize a resilient portion, and/or may be removably attached to the collection device body. The cap may form a fluid-tight seal with the body of the collection device. The cap may be formed of opaque, transparent or translucent material.

In one embodiment, the collection device body 120 of the sample collection device may include therein at least a portion of one or more collection passages, such as, but not limited to, channels 122a, 122b. It should be understood that collection paths that are not channels are not excluded. The collection device body may be connected to a bracket 130 which may contain a portion of one or more channels therein. The collection device body may be permanently fixed to the support, or may be removable relative to the support. In some cases, the collection device body and bracket may be formed from a single unitary piece. Alternatively, the collection device body and bracket may be formed from separate pieces. During operation of the device, the collection device and the holder do not move relative to each other.

Alternatively, the collection device body 120 may be formed in whole or in part from a light transmissive material. For example, the collection device body may be formed from a transparent or translucent material. Optionally, only selected portions of the body are transparent or translucent to allow visualization of one or more fluid collection channels. Optionally, the body includes an opaque material, but openings and/or windows may be formed in the body to show the fill level therein. The collection device body may enable a user to view the channels 122a, 122b within and/or through the device body. The channel may be formed of a transparent or translucent material, which may allow the user to see whether sample B has passed through the channel. The channels may have substantially the same length. In some cases, the stent 130 may be formed from an opaque material, a transparent material, or a translucent material. The holder may or may not have the same optical properties as the collection device body. The bracket may be formed of a different material than the body of the collection device, or of the same material as the body of the collection device.

The collection device body 120 may have any shape or size. In some examples, the collection device body may have a circular, oval, triangular, quadrilateral (eg, square, rectangular, trapezoidal), pentagonal, hexagonal, octagonal, or any other cross-sectional shape. The cross-sectional shape may remain the same or may vary along the length of the collection device body. In some cases, the collection device body can have less than or equal to about 10 cm ² , 7 cm ² , 5 cm ² , 4 cm ² , 3 cm ² , 2.5 cm ² , 2 cm ² , 1.5 cm ² , 1 cm ² , 0.8 cm ² , 0.5 cm ² , 0.3 cm ² or 0.1 cm ² of cross-sectional area. Along the length of the collection device body 120, the cross-sectional area may vary or may remain the same. The collection device body may have a length of less than or equal to about 20 cm, 15 cm, 12 cm, 10 cm, 9 cm, 8 cm, 7 cm, 6 cm, 5 cm, 4 cm, 3 cm, 2 cm, 1 cm, 0.5 cm, or 0.1 cm. The collection device body 120 may have a greater or lesser length than the cap, bracket or base, or the same length as the cap, bracket or base. Variations and substitutions are possible for the embodiments described herein, and no single embodiment should be construed as encompassing the entire invention.

In one embodiment, collection passages such as, but not limited to, channels 122a, 122b, may also have a selected cross-sectional shape. Some embodiments of the channel may have the same cross-sectional shape along the entire length of the channel. Alternatively, the cross-sectional shape may remain the same or may vary along the length. For example, some embodiments may have one shape at one location along the length of the channel and a different shape at one or more different locations. Some embodiments may have one channel with one cross-sectional shape and at least one other channel with a different cross-sectional shape. By way of non-limiting example, some embodiments may have a circular, oval, triangular, quadrilateral (eg, square, rectangular, trapezoidal), pentagon, hexagonal, octagonal, or any other cross-sectional shape. The cross-sectional shape may be the same or may vary for the body, bracket and base. Some embodiments may select the shape to maximize the volume of liquid that can be contained in the channel for a particular channel width and/or height. Some embodiments may have one of the channels 122a, 122b having one cross-sectional shape and the other channel having a different cross-sectional shape. In one embodiment, the cross-sectional shape of the channel can help maximize the volume therein, but optionally it can also optimize capillary pull on the blood. This will allow for maximum fill rate. It should be understood that, in some embodiments, the cross-sectional shape of the channel can directly affect the capillary force. By way of non-limiting example, a volume of sample can be contained in a shallow, wide channel or a circular channel, both containing the same volume, but with respect to fill velocity, lower likelihood of entrapped air, or incompatibility with the channel. In terms of performance-related factors, one channel may be more desirable than another.

While the channel may have any shape or size, some embodiments are configured such that the channel exhibits capillary action when in contact with the sample fluid. In some cases, the channel may have less than or equal to about 10mm ² , 7mm ² , 5mm ² , 4mm ² , 3mm ² , 2.5mm ² , 2mm ² , 1.5mm ² , 1mm ² , 0.8mm ² , 0.5mm ² , 0.3mm 2 ^mm2 or 0.1mm2 cross ^- sectional area. Along the length, the cross-sectional size may remain the same or may vary. Some embodiments may be tailored for larger forces along one length and then smaller forces on another length. Along the length, the cross-sectional shape may remain the same or may vary. Some channels are straight in configuration. Some embodiments may have curved or other shaped path shapes alone or in combination with straight sections. Some embodiments may have different orientations within the device body 120 . For example, when the device remains substantially horizontal, the one or more channels may slope downward, slope upward, or not slope as they carry fluid away from the initial collection point on the device.

The channels 122a, 122b may be supported by the device body 120 and/or the stand 130. In some cases, the full length of the channel may be contained within the device body and bracket combination. In some cases, a portion of the channel may be located within the device body, and a portion of the channel may be located within the stent. The location of the channel can be fixed by the device body and/or the stand. In some embodiments, the channel may be defined as a lumen within the hollow needle. In some embodiments, the channel is defined on only three sides, with at least one side being open. Optionally, a cover layer separate from the body may define a side that would otherwise be open. Some embodiments may define different sides of the channel with different materials. These materials may all be provided by the main body, or they may be provided by different parts of the collection device. Some embodiments may have channels all in the same plane. Optionally, some embodiments may have shapes that bring at least a portion of the channel to a different plane and/or orientation. Optionally, some channels may be entirely in different planes and/or orientations.

In some cases, multiple channels may be provided. In some embodiments, a channel is divided into two or more channels. Optionally, some channels are divided into an even larger number of channels. Some channels may include control mechanisms, such as, but not limited to, valves for directing flow in one or more channels. At least a portion of the channels may be substantially parallel to each other. Alternatively, no part of the channel need be parallel to each other. In some cases, at least a portion of the channels are not parallel to each other. Optionally, the channel may be slightly curved. Alternatively, the channel may have one cross-sectional area at one location and a smaller cross-sectional area at different locations along the channel. Alternatively, the channel may have one cross-sectional area at one location and a larger cross-sectional area at different locations along the channel. For some embodiments of the Y-shaped design, it may be desirable that the channels will have drain holes appropriately positioned to define the sample for each vial so that there is no sample pulled from other channels or cross-contamination. By way of non-limiting example, one embodiment with vent holes is shown in Figure 11I.

A base 140 may be provided within the sample collection device. The base can be connected to the bracket 130. In some cases, a portion of the base may be insertable within the cradle, and/or a portion of the cradle may be insertable within the base. The base may be movable relative to the stand. In some cases, the sample collection device can have a longitudinal axis extending along the length of the sample collection device. The base and/or the stand are movable relative to each other in the direction of the longitudinal axis. The base and/or the stand may be capable of moving a limited distance relative to each other. Alternatively, the base may be fixed relative to the bracket. The base may be provided at one end of the sample collection device opposite the end of the sample collection device including the cap 110. Optionally, some embodiments may include an integrated base/vessel component so that there is no longer a separate vessel assembled into the base part. Variations and substitutions are possible for the embodiments described herein, and no single embodiment should be construed as encompassing the entire invention.

The base 140 may receive one or more vessels therein. The vessel can be in fluid communication with the channel and/or can be brought into fluid communication with the channel. One end of the channel can be located in the vessel, or can be brought into the vessel. The base can have one or more optical indicators 142a, 142b that can provide a visual indication of whether the sample has reached one or more vessels housed in the base. In some embodiments, the optical indicator may be an optical window that enables a user to view into the base. The optical window may be formed of transparent and/or translucent material. Alternatively, the optical window may be an opening without any material therein. The optical window allows the user to directly observe the vessel within the base. The vessel within the base may be formed of a transparent and/or translucent material that may enable the user to see whether the sample has reached the vessel of the base. For example, if blood is transported along the channel to the vessel, the vessel can visually indicate the presence of blood therein. In other embodiments, the optical indicator may include other features that may indicate that the vessel has been filled. For example, one or more sensors may be provided within the base or vessel that can determine whether a sufficient amount of sample has been provided within the vessel. The one or more sensors may provide a signal to an optical indicator on the base that may indicate whether and/or the amount of sample that has been provided to the vessel. For example, the optical sensor may include a display, such as, but not limited to, an LCD display, a light display (e.g., an LED display), a plasma screen display, which may provide an indication that the vessel has been sufficiently filled. In alternative embodiments, an optical indicator need not be provided, but alternative indicators may be provided, such as, but not limited to, an audio indicator or a temperature-controlled indicator that may be used to indicate when the vessel has been filled.

2A-2C provide views of the sample collection device 200 without the cap 110. FIG. The sample collection device 200 may include a body 220 , a holder 230 and a base 240 . The main body can be attached to the bracket. In this embodiment, the base 240 may be connected to the bracket at an end opposite to the end connected to the main body. The body may support and/or contain at least a portion of one, two or more channels 222a, 222b. The channels may be capable of receiving samples 224a, 224b from the sample receiving end 226 of the device.

The body 220 may have a hollow portion 225 therein. Alternatively, the body may be formed from a solid piece. The channels 222a, 222b may be integrally formed into the body. For example, they may be passages through solid parts of the body. The vias can be drilled through or formed using photolithographic techniques. Alternatively, the channel may be a separate structure that may be supported by the body. For example, the channel may be formed by one or more tubes that may be supported by the body. In some cases, channels may remain in place at certain solid portions of the body and may pass through one or more hollow portions of the body. Alternatively, the body 220 may be formed from two pieces joined together to define channels 222a and 222b therein.

The channels 222a, 222b may include one or more of the features or characteristics mentioned elsewhere herein. At least a portion of the channels may be substantially parallel to each other. Alternatively, the channels may be angled relative to each other. In some embodiments, the channel can have a first end that can be located at the sample receiving end 226 of the sample collection device. The first end of the channel may be an open end capable of receiving a sample. In some embodiments, the end of each channel may be provided at the sample receiving end of the sample receiving device. One, two or more channels may have a first end at the sample receiving end of the sample collection device. Separate channels can be used to minimize the risk of blood cross-contamination between one channel and the other. Alternatively, the channels may have an inverted Y-shaped configuration, wherein the channels start from a common channel and divide into two or more separate channels. Such a Y-shaped configuration can be useful where contamination is not an issue. Alternatively, an alternative to the Y-shaped configuration would be a straight channel and move the sample collection vessel to sequentially engage the same needle from the straight channel.

In some cases, multiple channels may be provided. The ends of the channel at the sample receiving end can be in close proximity to each other. The ends of the channels at the sample receiving end may be adjacent to each other. The ends of the channels at the sample receiving end may touch each other, or may be at about 0.5mm, 1mm, 2mm, 3mm, 4mm, 5mm, 6mm, 7mm, 8mm, 9mm, 10mm, 12mm, edge to edge or center to center of each other. Within 15mm or 20mm. The channels may diverge from each other from the sample receiving end. For example, the other end of the channel opposite the end of the channel at the sample receiving end may be further away from each other. They may be spaced from each other edge to edge or center to center by greater than or equal to about 3mm, 4mm, 5mm, 6mm, 7mm, 8mm, 9mm, 10mm, 12mm, 15mm, 20mm, 25mm or 30mm.

In some embodiments, the body 220 may have an elongated shape. The body may have one or more tapered portions 228 at or near the sample receiving end 226. The sides of the body can converge at the sample receiving end. The tapered portion and/or the sample receiving end may be curved. Alternatively, edges can be provided. The surface of the tapered portion may be provided at any angle relative to the longitudinal axis of the device. For example, the tapered portion may be at about 5, 10, 15, 30, 45, 60, or 75 degrees relative to the longitudinal axis.

The sample receiving end 226 of the device can contact the sample. The sample can be provided directly from the subject. The sample receiving end may be in contact with the subject or in contact with the subject or a sample exuding from the subject. For example, the sample receiving end may touch a drop of blood on the subject's finger. The blood can enter the channel. The blood can be transported through the channel via capillary action, differential pressure, gravity or any other force. The blood can pass from the sample receiving end through the channel to the sample delivery end. The sample delivery end can be in fluid communication with one or more vessels housed within the base of the device or can be brought into fluid communication with the vessels. The sample can be transferred from the channel to the vessel. The sample can be driven into the vessel via differential pressure, capillary action, gravity, friction and/or any other force. Alternatively, the sample may also be blood introduced with a pipette, syringe, or the like. It should be understood that although

Figure 2B shows that Sample B only partially fills the channels 222a, 222b, but in most embodiments the channels will be completely filled with Sample B when the filling process is complete.

3A-3B illustrate an example of the sample collection device 300 prior to bringing the channels 322a, 322b into fluid communication with one or more vessels 346a, 346b housed within the base 340 of the device. The sample collection device may include a cap 310, a body 320, a holder 330, and a base 340. The body and/or the stand may support and/or contain at least a portion of one, two or more channels. The base may support and/or contain one, two or more vessels.

In one embodiment, the body 320 and/or the holder 330 may support one or more channels 322a, 322b in the sample collection device. In one example, two channels are provided, but the description of the two-channel embodiment may apply to any number of channels, including but not limited to 1, 3, 4, 5, 6, or more channels . Each channel can have a first end 323a, 323b, which can be provided at the sample receiving end 326 of the device. The first end of each channel may be open. The channel may be open to ambient air. When the first end of the channel contacts a fluid, such as blood, the fluid can be drawn into the channel. Blood can be drawn via capillary action or any other technique described elsewhere herein. The blood may travel along the length of the channel to the respective second ends 325a, 325b of the channel. The channels may be fluidly isolated from each other. For example, fluid may enter the first channel 322a via the first end 323a, traverse the length of the channel, and exit the first channel at the second end 325a. Similarly, fluid may enter second channel 322b via first end 323b, travel the length of the channel, and exit the second channel at second end 325b. The first and second channels may be fluidly isolated such that fluid from the first channel does not pass into the second channel, and vice versa. In some embodiments, the fluid can pass to the second end of the channel without leaving first.

The channels 322a, 322b may have a diverging configuration. For example, the first ends 323a, 323b of the channel may be closer to each other than the second ends 325a, 325b of the channel. More space may be provided between the second ends of the channels than between the first ends of the channels. The first ends of the channels may or may not be in contact with each other. The first ends of the channels may be adjacent to each other.

The base 340 can be connected to the holder 330 of the sample collection device. The base 340 may or may not be in direct contact with the bracket. The base may be movable relative to the stand during use of the device. In some embodiments, the base is longitudinally slidable relative to the support. In some cases, the base can slide longitudinally relative to the stand without rotating. In some cases, the base can slide coaxially with the bracket without rotating. In some cases, the base may rotate while moving relative to the stand. A portion of the base may fit within a portion of the bracket, or vice versa. For example, a portion of the base may be insertable into a portion of the cradle, and/or a portion of the cradle may be insertable into the base. One or more stop features may be provided in the base and/or frame to provide a controlled degree of movement between the base and the stand. Limiting features may include shelves, protrusions or grooves.

The base 340 may be capable of supporting one or more vessels 346a, 346b. The base can have a housing that can at least partially surround one or more vessels. In some cases, when the base is engaged with the bracket 330, the vessel may be completely enclosed. The base may have one or more depressions, protrusions, grooves or shaped features to receive vessels. The base may be formed to have a shape complementary to the shape of the vessel. The vessel can be held in an upright position relative to the base.

The same number of vessels as the number of channels can be provided. For example, if N channels are provided, then N vessels may be provided, where N is a positive integer (e.g., 1, 2, 3, 4, 5, 6, 7, 8, or more). Each channel may correspond to a corresponding vessel. In one example, the sample collection device may have first and second channels, and corresponding first and second vessels. The first channel 322a may be in fluid communication with the first vessel 346a or may be configured to be brought into fluid communication with the first vessel 346a, and the second channel 322b may be in fluid communication with the second vessel 346b or may be configured to be brought into fluid communication with the second vessel 346b into fluid communication with the second vessel 346b.

In some embodiments, each vessel may have a body 349a, 349b and a cap 348a, 348b. In some cases, the vessel body may be formed from a transparent or translucent material. The vessel body may allow a sample provided within the vessel body to be visible when viewed from outside the vessel. The vessel body may have a tubular shape. In some cases, the vessel body may have a cylindrical portion. The bottom of the vessel may be flat, tapered, rounded, or any combination thereof. The vessel may include an open end and a closed end. The open end may be the top end of the vessel, which may be located at the end of the vessel closer to the one or more channels. The closed end may be the bottom end of the vessel, which may be located at the end of the vessel further away from the one or more channels. Various embodiments of the vessel can be described in greater detail elsewhere herein.

The base 340 may have one or more optical indicators, such as optical windows 342a, 342b. Optical windows may be positioned over the vessels 346a, 346b. In some cases, the optical window may be positioned over the vessel body. A single window can provide viewing of a single vessel or multiple vessels. In one example, the same number of optical windows as vessels can be provided. Each optical window may correspond to a corresponding vessel. Both the optical window and the vessel may be formed from a light transmissive material that allows a user to observe from the outside of the sample collection device whether the sample has reached the vessel.

In some embodiments, there may be optical windows for channels 322a and 322b so that a user can observe when a desired fill level has been achieved in the channels. In some embodiments where the body 320 is completely transparent or translucent, there may be markers or indicator markings along the channel to mark when the desired fill level has been achieved.

The vessel can be sized to accommodate small fluid samples. In some embodiments, the vessel can be configured to hold no more than about 5ml, 4ml, 3ml, 2ml, 1.5mL, 1mL, 900uL, 800uL, 700uL, 600uL, 500uL, 400uL, 300uL, 250uL, 200uL, 150uL, 100uL , 80uL, 50uL, 30uL, 25uL, 20uL, 10uL, 7uL, 5uL, 3uL, 2uL, 1uL, 750nL, 500nL, 250nL, 200nL, 150nL, 100nL, 50nL, 10nL, 5nL or 1nL. The vessel may be configured to contain no more than several drops of blood, one drop of blood, or no more than a portion of one drop of blood.

The vessel may include caps 348a, 348b. The plug can be configured to fit over the open end of the vessel. The cap blocks the open end of the vessel. The cap fluidly seals the vessel. The cap can form a fluid-tight seal with the vessel body. For example, the cap may be gas impermeable and/or liquid impermeable. Alternatively, the cap may allow certain gases and/or liquids to pass through. In some cases, the cap may be breathable and liquid-tight. The cap may be impermeable to the sample. For example, the cap may be impermeable to whole blood, serum or plasma. In some cases, a portion of the cap may fit into a portion of the vessel body. The cap may form a plug with the vessel body. The cap may include a flange or shelf that can overlie a portion of the vessel body. A flange or shelf prevents the cap from sliding into the vessel body. In some cases, a portion of the cap may overlie the top and/or sides of the vessel body. Any description of vessels herein may be applicable in combination with a sample collection device. Optionally, some embodiments may include additional components in the vessel assembly, such as cap holders. In one embodiment, the purpose of the cap retainer is to maintain a tight seal between the cap and the vessel. In one embodiment, the cap retainer engages an attachment, flange, recess or other attachment location on the exterior of the vessel to hold the cap in place. Alternatively, some embodiments may combine the functionality of both cap and cap retainer into one assembly.

One or more joint assemblies may be provided. The engagement assembly may include a channel retainer 350 and/or a force applying component, such as a spring 352 or a rubber band. In one embodiment, retainer 350 may hold adapter channel 354 secured to the bracket. As will be described elsewhere herein, the adapter channel 354 may be integrally formed with the collection channel, or may be a discrete element, which may be a separate piece, part of the collection channel, or part of the vessel. In one embodiment, the retainer 350 may prevent the adapter channel 354 from sliding relative to the bracket. Retainer 350 may optionally provide a bracket upon which a force-applying component, such as a spring, may rest.

In one example, the engagement assemblies can each include a spring 352 that can apply a force such that the base 340 is in an extended state when the spring is in its natural state. When the base is in its extended state, space may be provided between the vessels 346a, 346b and the engagement assembly. In some cases, the second end of the channel may or may not contact the cap of the vessel when the base 340 is in its extended state. The second ends of the channels 325a, 325b may be in a position where they are not in fluid communication with the interior of the vessel.

The sample collection device can have any number of engagement assemblies. For example, the same number of engagement assemblies may be provided as the number of channels. Each channel may have one engagement assembly. For example, if a first channel and a second channel are provided, the first channel may be provided with a first engagement assembly and the second channel may be provided with a second engagement assembly. The same number of joint assemblies and vessels can be provided.

In one embodiment, the engagement assembly can receive an adapter channel 354, such as, but not limited to, an elongated member having angled, tapered or sharpened ends 327a and 327b. It will be appreciated that, in some embodiments, the ends 327a and 327b are part of a needle formed separately from the channels 322a and 322b and then coupled to the channels 322a and 322b. The needle may be formed of the same or a different material from the body that defines the channels 322a and 322b. For example, some embodiments may use metal to form the needle, while a polymer or plastic material is used for the body that defines the channels 322a and 322b. Alternatively, some embodiments may form ends 327a and 327b on members integrally formed with channels 322a and 322b. In some cases, the second end of the channel may be configured to penetrate material, such as the caps 348a, 348b of the vessel. In some embodiments, a portion of the adapter channel 354 may be insertable within the collection channel, or a portion of the collection channel may be insertable within the adapter channel, or the two may be configured for flush alignment. Alternatively, some embodiments may have the adapter channel 354 integrally formed with the collection channel 322a. It should be understood that Figure 3B (and Figure 4B) shows that Sample B only partially fills the channels 122a, 122b, but in most embodiments the channels will be completely filled with Sample B when the filling process is complete. Variations and substitutions are possible for the embodiments described herein, and no single embodiment should be construed as encompassing the entire invention.

4A-4B illustrate an example of a sample collection device 400 having channels 422a, 422b in fluid communication with the interior of vessels 446a, 446b within the device. The sample collection device may include a cap 410, a body 420, a holder 430, and a base 440. The body and/or the bracket may support and/or contain at least a portion of one, two or more channels. The base may support and/or contain one, two or more vessels.

In one embodiment, the body 420 and/or the holder 430 can support one or more channels 422a, 422b in the sample collection device. For example, a first channel and a second channel may be provided. Each channel can have a first end 423a, 423b, which can be provided at the sample receiving end 426 of the device. The first end of each channel may be open. The channel may be open to ambient air. When the first end of the channel contacts a fluid, such as blood, the fluid can be drawn into the channel. The fluid may be drawn in via capillary action or any other technique described elsewhere herein. The fluid may travel along the length of the channel to the respective second ends 425a, 425b of the channel. In some embodiments, the fluid can reach the second end of the channel via capillary action or other techniques described herein. In other embodiments, the fluid need not reach the second end of the channel. The channels may be fluidly isolated from each other.

In some embodiments, when the channel is not in fluid communication with the interior of the vessel 446a, 446b, the fluid can pass to the second end of the channel without exiting. For example, fluid can be drawn into the channel via capillary action, which can cause the fluid to flow toward or near the end of the channel without causing the fluid to exit the channel.

The base 440 can be connected to the holder 430 of the sample collection device. The base may be movable relative to the stand during use of the device. In some embodiments, the base is longitudinally slidable relative to the bracket. In one example, the base may have (i) an extended position in which the channel is not in fluid communication with the interior of the vessel, and (ii) a compressed position in which the channel is in fluid communication with the interior of the vessel. The sample collection device may be initially provided in an extended state, as shown in Figure 3 . After the sample has been collected and flowed through the length of the channel, the user can push in the base to provide the sample collection device in its compressed state, as shown in Figure 4. Once the base has been pushed in, the base can naturally remain pushed in, or can spring back to an extended state once the push is removed. In some cases, the base can be pulled out to an extended state, or can be pulled out completely to provide access to the vessel therein.

The base 440 may be capable of supporting one or more vessels 446a, 446b. The base may have a housing that may at least partially surround the one or more vessels. In some cases, when the base is engaged with the bracket 430, the vessel may be completely enclosed. The base may have one or more depressions, protrusions, grooves or shaped features to receive vessels. The base may be formed to have a shape complementary to the shape of the vessel. The vessel can be held in an upright position relative to the base.

The same number of vessels as the number of channels can be provided. Each channel may correspond to a corresponding vessel. In one example, the sample collection device may have first and second channels, and corresponding first and second vessels. The first channel 422a may be in fluid communication with the first vessel 446a or may be configured to be brought into fluid communication with the first vessel, and the second channel 422b may be in fluid communication with the second vessel 446b or may be configured to be brought into fluid communication with the first vessel 446b into fluid communication with the second vessel. The first channel may initially be out of fluid communication with the first vessel, and the second channel may be initially out of fluid communication with the second vessel. The first and second channels can be brought into fluid communication with the interior of the first vessel and the second vessel, respectively, when the base is pushed in relative to the holder. The first channel and the second channel can be brought into fluid communication with the first vessel and the second vessel simultaneously. Alternatively, they need not be brought into fluid communication simultaneously. The timing of fluid communication may depend on the height of the vessel and/or the length of the channel. The timing of fluid communication may depend on the relative distance between the second end of the channel and the vessel.

In some embodiments, each vessel may have a body 449a, 449b and a cap 448a, 448b. The vessel body may have a tubular shape. In some cases, the vessel body may have a cylindrical portion. The bottom of the vessel may be flat, tapered, rounded, or any combination thereof. The vessel may include an open end and a closed end. The open end can be the top end of the vessel, which can be located at the end of the vessel closer to the one or more channels. The closed end may be the bottom end of the vessel, which may be located at the end of the vessel further away from the one or more channels.

The base 440 may have one or more optical indicators, such as optical windows 442a, 442b. Optical windows may be positioned over vessels 446a, 446b. In some cases, the optical window may be positioned over the vessel body. Both the optical window and the vessel may be formed from a light transmissive material that allows the user to observe from outside the sample collection device whether the sample has reached the vessel. In some embodiments, the vessel may contain markers on the vessel itself to indicate fill level requirements.

The vessel may include caps 448a, 448b. The cap can be configured to fit over the open end of the vessel. The cap blocks the open end of the vessel. The cap fluidly seals the vessel. The cap can form a fluid-tight seal with the vessel body. For example, the cap may be impermeable to whole blood, serum or plasma. In some cases, a portion of the cap may fit into a portion of the vessel body. The cap may include a flange or shelf that can overlie a portion of the vessel body. In some embodiments, the cap may have a hollow or dimple. The hollow or dimple can help guide the second end of the channel to the center of the cap. In some cases, the second ends of the channels 425a, 425b may be located above the cap of the vessel when the sample collection device is in the extended state. The second end of the channel may or may not contact the vessel cap. In some cases, the second end of the channel may be placed within the hollow or pocket of the cap. In some cases, the second end of the channel may partially penetrate the cap without reaching the interior of the vessel. Optionally, some embodiments of the cap may include a crimp to maintain a vacuum.

The second end of the channel may have angled, tapered or sharpened ends 427a and 427b. It will be appreciated that, in some embodiments, the ends 427a and 427b are part of a needle formed separately from the channels 422a and 422b and then coupled to the channels 422a and 422b. The needle may be formed of the same or a different material from the body that defines the channels 422a and 422b. For example, some embodiments may use metal to form the needle, while a polymer or plastic material is used for the body that defines the channels 422a and 422b. Alternatively, some embodiments may form ends 427a and 427b on members integrally formed with channels 422a and 422b. In some cases, the second end of the channel may be configured to penetrate material, such as the caps 448a, 448b of the vessel. The cap can be formed of a material that prevents the sample from passing through in the absence of a penetrating member. The cap may be formed from a single solid piece. Alternatively, the cap may include slits, openings, holes, thin sections, or any other feature that accepts a penetrating member. The slit or other opening may be capable of retaining the sample therein when the penetrating member is not in the slit or opening, or when the penetrating member is removed from the slit or opening. In some cases, the cap may be formed of a self-healing material such that when the penetrating member is removed, the opening formed by the penetrating member closes. The second end of the channel can be a penetrating member that can be passed through the cap and into the interior of the vessel. In some embodiments, it should be appreciated that the penetrating member may be a hollow needle that allows a sample to pass through, not just a needle for puncturing. In some embodiments, the piercing tip may be a non-coring design, such as, but not limited to, a tapered cannula that pierces without coring the cap material.

One or more joint assemblies may be provided. The engagement assembly may include a channel retainer 450 and/or a force applying component, such as a spring 452 or a rubber band. In one embodiment, retainer 450 may hold adapter channel 454 secured to the bracket. As will be described elsewhere herein, the adapter channel 454 may be integrally formed with the collection channel, or may be a discrete element, which may be a separate piece, part of the collection channel, or part of the vessel. In one embodiment, retainer 450 may prevent adapter channel 454 from sliding relative to the bracket. Retainer 450 may optionally provide a bracket upon which a force-applying component, such as a spring, may reside.

In one example, the engagement assembly can include a spring 452 that can apply a force such that when the spring is in its natural state, the base is in its extended state. When the base is in its extended state, space may be provided between the vessels 446a, 446b and the engagement assembly. The second ends of the channels 425a, 425b may be in a position where they are not in fluid communication with the interior of the vessel.

The sample collection device can have any number of engagement assemblies. For example, the same number of engagement assemblies may be provided as the number of channels. Each channel may have one engagement assembly. For example, if a first channel and a second channel are provided, the first channel may be provided with a first engagement assembly and the second channel may be provided with a second engagement assembly. In one embodiment, the same number of engagement assemblies and vessels may be provided.

When pressed into the base, the spring 452 may be compressed. The second ends 425a, 425b of the channel can penetrate the cap of the vessel. The second end of the channel can enter the interior of the vessel. In some cases, a force may be provided to drive fluid from the channel into the vessel. For example, a pressure differential can be created between the first end and the second end of the channel. Positive pressure may be provided at the first ends 423a, 423b of the channel and/or negative pressure may be provided at the second end of the channel. The positive pressure may be positive relative to the pressure of the air at the second end of the channel and/or surrounding air. The negative pressure may be negative relative to the pressure of the air at the first end of the channel and/or surrounding air. In one example, the vessel may have a vacuum therein. When the second end of the channel penetrates the vessel, the negative pressure within the vessel can pull the sample into the vessel. In alternative embodiments, the sample may be driven into the vessel by capillary force, gravity, or any other power. In embodiments, the vessel does not have a vacuum therein. Variations and substitutions are possible for the embodiments described herein, and no single embodiment should be construed as encompassing the entire invention.

In some cases, different types of power can be used at different stages of sample collection. Thus, one type of power can be used to draw the sample into the channel, and then a different type of power can be used to move the sample from the channel into the vessel. For example, capillary force can draw the sample into the channel, while differential pressure can drive the sample from the channel into the vessel. Any combination of power can be used to draw the sample into the channel neutralization vessel. In some embodiments, the one or more powers used to draw the sample into the channel are different from the one or more powers used to draw the sample into the vessel. In some alternative embodiments, the one or more powers may be the same for each stage. In some embodiments, one or more powers are applied sequentially or for a defined period of time. By way of non-limiting example, the power or powers to draw the sample into the vessel are not applied until at least one channel has reached a minimum fill level. Optionally, the power or powers to draw the sample into the vessel are not applied until at least two channels have each reached a minimum fill level for that channel. Optionally, the power or powers to draw the sample into the vessel are not applied until all channels have each reached a minimum fill level for that channel. In some embodiments, one or more powers are applied simultaneously.

Some embodiments may use a pressurized gas source coupled to the sample collection device and configured to push the collected bodily fluid from one or more channels into its corresponding vessel. Alternatively, some embodiments may use a vacuum source not associated with the vessel to pull the sample fluid toward the vessel.

Furthermore, some embodiments of the channel may be configured such that there is sufficient capillary force within the channel such that, once filled, the force is greater than gravity so that the sample does not escape from the channel based solely on gravity. The additional power is used to break the hold of the capillary action of one or more channels. Optionally, as described elsewhere herein, a device such as, but not limited to, a sleeve can contain bodily fluids from exiting the channel at the end closest to the vessel, thereby minimizing any losses until transfer to the vessel begins.

Alternatively, other materials such as, but not limited to, lyospheres, sponges, or other power providers, etc., may be used to provide the power to draw the sample into the vessel. When multiple forces are used, this can be the primary, secondary or tertiary power used to draw the sample into the vessel. Optionally, some embodiments may include a push power provider, such as but not limited to a plunger, to move the sample in a desired manner.

After the sample has been introduced into the channel, some time may elapse for the sample to travel the length of the channel. The user can introduce a sample into the sample collection device and can wait for the sample to travel the length of the channel. One or more optical indicators can be provided that can indicate whether the sample has reached a desired fill level, such as but not limited to reaching the end of the channel. In other embodiments, the user may wait a predetermined amount of time before pushing in the base. After the user has determined that the sample has traveled a sufficient length of the channel and/or that a sufficient amount of time has elapsed since the sample was introduced, the base can be pushed in. After the base is pushed in, the channel can be brought into fluid communication with the vessel and the sample can flow from the channel into the vessel. An optical indicator can be provided so that the user can know when the vessel is filled.

Once the vessel has been filled, it can be transferred to the desired location using the systems and methods described elsewhere herein. In some cases, the entire sample collection device can be transferred. A cap can be placed on the sample collection device for transfer. In other embodiments, the base portion and/or the stand portion may be removable from the rest of the device. In one example, the base can be removed from the sample collection device, and the vessel can be transferred along with the base. Alternatively, the base can be removed from the sample collection device to provide access to the vessel, and the vessel can be removed and transported from the device. Removal of the base may involve some disassembly of the sample collection device in order to remove the base. This may involve using sufficient force to overcome stops or stops built into the device to prevent accidental disengagement. Optionally, some other active action by the user, such as but not limited to disengaging a latch or other locking mechanism, may be performed by the user prior to removing the base. Alternatively, some embodiments may allow removal of the vessel without removing the base, but allow access to the vessel through openings in the base, access ports, or openable covers.

In some embodiments, one or more of the channels and/or vessels may include features described elsewhere herein, such as separation members, coatings, anticoagulants, beads, or any other feature. In one example, the sample introduced to the sample collection device can be whole blood. Two channels and corresponding vessels can be provided. In this non-limiting example, each channel has a coating, such as, but not limited to, an anticoagulant coating in the channel. Such anticoagulant coatings may perform one or more of the following functions. First, anticoagulants prevent whole blood from clotting in the channel during the sample collection process. Depending on the volume of whole blood to be collected, coagulation may prematurely block the channel before a sufficient amount of blood has been brought into the channel. Another function is to introduce anticoagulants into whole blood samples. By having the anticoagulant in the channel, the process can begin earlier in the collection process relative to some embodiments that may only have the anticoagulant in the vessel 446a or 446b. In situations where a whole blood sample will be directed along a pathway that may have a portion uncoated with anticoagulant, such as, but not limited to, the inner surface of a needle connected to channel 422a or 422b, such an anticoagulant Early introduction can also be advantageous. Optionally, some embodiments may include surfactants that can be used to modify the contact angle (wettability) of the surface.

In some embodiments, the inner surface of the channel and/or other surfaces along the fluid pathway, such as, but not limited to, the sample inlet to the interior of the sample collection vessel, may be coated with a surfactant and/or anticoagulant solution. The surfactant provides a wettable surface for the hydrophobic layer of the fluidic device and facilitates filling of the metering channel with a liquid sample such as blood. Anticoagulant solutions help prevent samples such as blood from clotting when provided to the fluidic device. Exemplary surfactants that can be used include, but are not limited to, Tween, 20. Sodium deoxycholate, Triton, X-100, Pluronic and/or other non-hemolytic detergents that provide the appropriate wetting properties of surfactants. EDTA and heparin are non-limiting anticoagulants that can be used. In one non-limiting example, an embodiment solution comprises 2% Tween, 25 mg/mL EDTA in 50% methanol/50% H2O, which is then air dried. The methanol/water mixture provides a means of dissolving EDTA and Tween, and also dries quickly from the surface of the plastic. The solution can be applied to the channel or other surface along the fluid flow path by any technique (eg, pipetting, spraying, printing, or wicking) that will ensure that a uniform film is applied to the surface.

It should also be understood that for any of the embodiments herein, the coating in the channel may extend along the entire path of the channel. Optionally, the coating may cover most but not all of the channel. Optionally, some embodiments may leave the channels uncovered in the area closest to the access opening to minimize the risk of cross-contamination, wherein by having all channels in simultaneous contact with the target sample fluid and thus having communicating fluid pathways, Coating material from one channel migrates into a nearby channel.

Although embodiments herein have been shown with two separate channels located in the sample collection device, it should be understood that some embodiments may use more than two separate channels. Alternatively, some embodiments may use less than two completely separate channels. Some embodiments may use only one separate channel. Alternatively, some embodiments may use an inverted Y-shaped channel that starts out as one channel and then splits into two or more channels. Any of these concepts may be adapted for use with the other embodiments described herein.

Collection device with self-supporting collection channel

5A-5B provide another example of a sample collection device 500 provided in accordance with embodiments described herein. The sample collection device may include a collection device body 520 , a holder 530 and a base 540 . In some cases, a cap may optionally be provided. The collection device body may contain one or more collection channels 522a, 522b defined by collection tubes that may be capable of receiving a sample. The base can have one or more optical indicators 542a, 542b that can provide a visual indication of whether the sample has reached one or more vessels housed in the base. The holder can have one or more optical indicators 532a, 532b that can provide a visual indication of whether a sample has reached or passed through a portion of the channel.

The collection device body 520 of the sample collection device may include at least a portion of one or more tubes having channels 522a, 522b therein. Optionally, the device collection body 520 may also define channels coupled to the channels 522a, 522b defined by the tubes. In some embodiments, a portion of the channel may extend beyond the body of the collection device. The channel may extend beyond one or both ends of the body of the collection device.

The collection device body 520 may be connected to the bracket 530 . The stent may contain a portion of one or more channels therein. The collection device body may be permanently affixed to the holder, or may be removable relative to the holder. In some cases, the collection device body and bracket may be formed from a single unitary piece. Alternatively, the collection device body and bracket may be formed from separate parts.

During operation of the device, the collection device body 520 and the bracket 530 are movable relative to each other. In some cases, a portion of the body 520 may be insertable within the bracket 530, and/or a portion of the bracket may be insertable within the body. The body may be movable relative to the stand. In some cases, the sample collection device may have a longitudinal axis extending along the length of the sample collection device. The body and/or the support are movable relative to each other in the direction of the longitudinal axis. The body and/or the stand may be capable of moving a limited distance relative to each other. The body and/or the stand can move coaxially without rotational movement. Alternatively, rotational motion may be provided.

The collection device body 520 may be formed of a light transmissive material. For example, the collection device body may be formed from a transparent or translucent material. Alternatively, the body may be formed from an opaque material. The bracket 530 may be formed of an optically opaque, translucent, or transparent material. The holder may or may not have the same optical properties as the collection device body. The bracket may be formed of a different material than the body of the collection device, or the same material as the body of the collection device. Variations and substitutions are possible for the embodiments described herein, and no single embodiment should be construed as encompassing the entire invention.

The collection device body, stand and/or base may have any shape or size. In some examples, the collection device body, bracket, and/or base may have a circular, oval, triangular, quadrilateral (eg, square, rectangular, trapezoidal), pentagon, hexagonal, octagonal, or any other shape cross-sectional shape. Along the length, the cross-sectional shape may remain the same or may vary. The cross-sectional shape may be the same or may vary for the body, bracket and/or base. In some cases, the collection device body, stand, and/or base can have a thickness of less than or equal to about 10 cm ² , 7 cm ² , 5 cm ² , 4 cm ² , 3 cm ² , 2.5 cm ² , 2 cm ² , 1.5 cm ² , 1 cm ² , A cross-sectional area of 0.8 cm ² , 0.5 cm ² , 0.3 cm ² or 0.1 cm ² . Along the length, the cross-sectional area may vary or may remain the same. The cross-sectional size may be the same or may vary for the collection body, holder and base. The collection device body, support, and/or base can have a length of less than or equal to about 20 cm, 15 cm, 12 cm, 10 cm, 9 cm, 8 cm, 7 cm, 6 cm, 5 cm, 4 cm, 3 cm, 2 cm, 1 cm, 0.5 cm, or 0.1 cm . The collection device body may have a greater or lesser length than the stand or base, or the same length as the stand or base.

Channels 522a, 522b may be supported by device body 520 and/or bracket 530. In some cases, the full length of the tube or channel therein may be contained within the device body and stent combination. Alternatively, the channel may extend beyond the device body and/or the stand, as seen in Figure 5. In some cases, the channel may extend beyond one end of the device body/support combination, or beyond both ends. In some cases, a portion of the channel may be within the body of the device, and a portion of the channel may be within the stent. The location of the channel can be fixed by the device body and/or the stand. In some cases, the channel may be fixed to the device body and/or not move relative to the device body. The channel may be movable relative to the stand. In some cases, multiple channels may be provided. At least a portion of the channels may be substantially parallel to each other. The channels may be parallel to each other and/or longitudinal axes extending along the length of the sample collection device. Alternatively, no part of the channel need be parallel to each other. In some cases, at least a portion of the channels are not parallel to each other. The channel can be slightly curved. Alternatively, they may be straight, but aligned closer to each other as they approach the sample collection point. It should be appreciated that the tubes defining channels 522a and 522b may be made of optically transparent materials, transmissive materials, or other materials sufficient to provide a detectable change in that the sample has reached a desired fill level in at least one channel. Alternatively, the detectable change can be used to detect when both channels have at least reached the desired fill level.

A base 540 may be provided within the sample collection device. The base can be connected to the bracket 530. In some cases, a portion of the base 540 may be insertable within the bracket 530, and/or a portion of the bracket may be insertable within the base. The base may be fixed relative to the bracket, or it may be movable relative to the bracket. The base may be provided at one end of the bracket opposite to one end of the bracket connected to the body. The base may be formed as a separate part from the bracket. The base may be detachable from the stand. Alternatively, the base may be affixed to and/or formed as an integral piece with the bracket.

The base 540 may receive one or more vessels therein. The vessel can be in fluid communication with the channel and/or can be brought into fluid communication with the channel. One end of the channel can be in the vessel, or it can be brought into the vessel. The base can have one or more optical indicators 542a, 542b that can provide a visual indication of whether the sample has reached one or more vessels housed in the base. In some embodiments, the optical indicator may be an optical window that enables a user to look into the base. The optical window may be formed of transparent and/or translucent materials. Alternatively, the optical window may be an opening without any material therein. The optical window allows the user to directly observe the vessel within the base. The vessel within the base may be formed of a transparent and/or translucent material that may enable a user to see whether a sample has reached the vessel of the base. For example, if blood is transported along the channel to the vessel, the vessel may show the blood therein. In other embodiments, the optical indicator may include other features to indicate that the vessel has been filled. For example, one or more sensors can be provided within the base or vessel that can determine whether a sufficient amount of sample has been provided within the vessel. The sensor can provide a signal to an optical indicator on the base that can indicate whether and/or how much sample has been provided to the vessel. For example, the optical sensor may include a display, such as an LCD display, a light display (e.g., an LED display), a plasma screen display, which may provide an indication that the vessel has been sufficiently filled. In alternative embodiments, an optical indicator need not be provided, but an alternative indicator may be provided, such as, but not limited to, an audio indicator that can indicate by a detectable signal (such as a signal detectable by a user) when the vessel has been filled , temperature control indicators or other devices.

The rack 530 can have one or more optical indicators 532a, 532b that can provide a visual indication of whether a sample has reached or passed through a portion of the channel contained by the rack. In some embodiments, the optical indicator may be an optical window that enables the user to look into the cradle. Optical windows may be formed from transparent and/or translucent materials. Alternatively, the optical window may be an opening without any material therein. The optical window may enable the user to directly view a portion of the channel within the cradle. The channel may be formed of transparent and/or translucent material, which may enable the user to see if the sample has reached the portion of the channel below the optical window. In other embodiments, the optical indicator may include other features that may indicate that the sample has passed through a portion of the channel, such as the sensors described elsewhere herein.

Referring now to Figures 6A-6B, additional views of a sample collection device 500 are provided in accordance with one embodiment described herein.

In some embodiments, a portion of the tube containing the channels 522a, 522b can extend beyond the collection device body 520. The portion of the channel that extends may include the portion of the channel that is configured to receive a sample from the subject. In one example, the channel may have first ends 523a, 523b, which may be the sample receiving end of the channel.

The channel may optionally be defined by a rigid material. Alternatively, the channel may be defined by a flexible material, or may have flexible components. Channels may or may not be designed to bend or bend. The channels may or may not be substantially parallel to each other. In some cases, the first ends of the channels may be spaced a distance apart when in the relaxed state. The first ends of the channels may remain separated by this distance during operation of the device. Alternatively, the first ends of the channels may be brought closer to each other. For example, the first ends of the channels may be squeezed together. Each open end of the channel can receive a sample individually. Samples can be received in sequence. The samples can be from the same subject. Alternatively, channels may be able to receive the same sample simultaneously.

The channels 522a, 522b may include one or more of the features or characteristics mentioned elsewhere herein. At least a portion of the channels may be substantially parallel to each other. Alternatively, the channels may be angled relative to each other. In some embodiments, the channel can have a first end that can be located at the sample receiving end 526 of the sample collection device. The first end of the channel may be an open end capable of receiving a sample. In some embodiments, the end of each channel may be provided at the sample receiving end of the sample receiving device. One, two or more channels may have a first end located at the sample receiving end of the sample collection device.

In some embodiments, the device body 520 may be movable relative to the stand 530. A portion of the device body may be insertable within the holder, or vice versa. In one example, the device body may have a flange 527 and an inner portion 529 . The flange may have a larger cross-sectional area than the inner portion. The inner part may be capable of being inserted into the bracket. The flange can act as a stop to prevent the entire body from being inserted into the bracket. The flange may be located on the shoulder of the bracket.

7A-7B illustrate partial cross-sectional views of an example of a sample collection device 700 provided in accordance with embodiments described herein. The sample collection device is in an extended state prior to bringing the channels 722a, 722b into fluid communication with one or more vessels 746a, 746b housed in the base 740 of the device. The sample collection device may include a body 720 , a holder 730 and a base 740 . The body and/or the stand may support and/or contain at least a portion of one, two or more channels. The base may support and/or contain one, two or more vessels. Variations and substitutions are possible for the embodiments described herein, and no single embodiment should be construed as encompassing the entire invention.

In one embodiment, the body 720 and/or the holder 730 can support one or more channels 722a, 722b in the sample collection device. In one example, two channels are provided, but the description of the two-channel embodiment may apply to any number of channels, including but not limited to 1, 3, 4, 5, 6, or more channels . Each channel can have a first end 723a, 723b, which can be the sample receiving end of the device. The first end of each channel may be open. The channel may be open to ambient air. When the first end of the channel contacts a fluid, such as blood, the fluid can be drawn into the channel. The fluid can be drawn in via capillary action or any other technique described elsewhere herein. The fluid can travel along the length of the channel to a respective second end of the channel. The channels may be fluidly isolated from each other. For example, fluid may enter the first channel 722a via the first end 723a, traverse the length of the channel, and exit the first channel at the second end. Similarly, fluid can enter the second channel 722b via the first end 723b, traverse the length of the channel, and exit the second channel at the second end. The first and second channels may be fluidly isolated so that fluid from the first channel does not pass into the second channel, and vice versa. In some embodiments, the fluid can pass to the second end of the channel without leaving first.

The channels 722a, 722b may have a parallel configuration. For example, the first ends 723a, 723b of the channels may be approximately the same distance apart as the second ends of the channels. The first ends of the channels may or may not be in contact with each other.

The bracket 730 may have one or more optical indicators, such as optical windows 732a, 732b. Optical windows may be positioned over the channels 722a, 722b. In some cases, an optical window may be positioned over a portion of the channel. A single window provides viewing of a single channel section or multiple channel sections. In one example, the same number of optical windows as channels can be provided. Each optical window may correspond to a corresponding channel. Both the optical window and the channel may be formed of a light transmissive material, which may allow a user to observe from outside the sample collection device whether a sample has reached and/or passed through the portion of the channel below. Such a determination can be used to determine when to compress the sample collection device.

The base 740 can be connected to the holder 730 of the sample collection device. The base may or may not be in direct contact with the bracket. During use of the device, the base may be fixed relative to the stand. In some cases, the base may be removable from the stand. A portion of the base may be insertable into the bracket, and/or vice versa. In some embodiments, the base can slide out of the stand in a longitudinal direction relative to the stand. In some cases, the base can slide coaxially with the bracket without rotating. In some cases, the base may rotate while moving relative to the stand.

The base 740 may be capable of supporting one or more vessels 746a, 746b. The base may have a housing that may at least partially surround the one or more vessels. In some cases, when the base is engaged with the bracket 730, the vessel may be completely enclosed. The height of the base can extend beyond the height of the vessel. Alternatively, the height of the base may extend to the same extent as the height of the vessel or less than the height of the vessel. The base may have one or more depressions, protrusions, grooves or shaped features to receive vessels. The base may be formed to have a shape complementary to the shape of the vessel. For example, the base may have one or more tubular recesses into which tubular vessels may snugly fit. The vessel can be friction fit into the base. The vessel can be held in an upright position relative to the base. Variations and substitutions are possible for the embodiments described herein, and no single embodiment should be construed as encompassing the entire invention.

The same number of vessels as the number of channels can be provided. For example, if N channels are provided, then N vessels may be provided, where N is a positive integer (e.g., 1, 2, 3, 4, 5, 6, 7, 8, or more). Each channel may correspond to a corresponding vessel. In one example, the sample collection device may have first and second channels, and corresponding first and second vessels. The first channel 722a may be in fluid communication with the first vessel 746a or may be configured to be brought into fluid communication with the first vessel, and the second channel 722b may be in fluid communication with the second vessel 746b or may be configured to be brought into fluid communication with the first vessel 746b into fluid communication with the second vessel.

In some embodiments, each vessel may have a body 749a, 749b and a cap 748a, 748b. The vessel may have any of the features or characteristics as described elsewhere herein.

The base 740 may have one or more optical indicators, such as optical windows 742a, 742b. Optical windows may be positioned over the vessels 746a, 746b. In some cases, the optical window may be positioned over the vessel body. A single window provides viewing of a single vessel or multiple vessels. In one example, the same number of optical windows as vessels can be provided. Each optical window may correspond to a corresponding vessel. Both the optical window and the vessel may be formed from a light transmissive material, which may allow the user to observe from the outside of the sample collection device whether the sample has reached the vessel. Such a visual assessment can be used to determine when the sample has reached the vessel and when the base can be removed from the sample collection device.

One or more joint assemblies may be provided. The engagement assembly may include a channel retainer 750 and/or a force applying component, such as a spring 752 or a rubber band. In one embodiment, retainer 750 may hold adapter channel 754 secured to the bracket. As will be described elsewhere herein, the adapter channel 754 may be integrally formed with the collection channel, or may be a discrete element, which may be a separate piece, part of the collection channel, or part of the vessel. In one embodiment, the retainer 750 can prevent the adapter channel 754 from sliding relative to the bracket. Retainer 750 may optionally provide a bracket upon which a force-applying component, such as a spring, may reside.

In one example, the engagement assembly can include a spring 752 that can apply a force such that when the spring is in its natural state, the body 720 is in an extended state. When the body is in its extended state, space may be provided between the vessels 746a, 746b and the engagement assembly. The inner portion 729 of the body may be exposed and/or uncovered by the bracket 730 when the body is in its extended state. In some cases, the second ends of the channels 722a, 722b may or may not contact the cap of the vessel when the body is in its extended state. The second ends of the channels may be in a position where they are not in fluid communication with the interior of the vessel. Variations and substitutions are possible for the embodiments described herein, and no single embodiment should be construed as encompassing the entire invention.

The sample collection device can have any number of engagement assemblies. For example, the same number of engagement assemblies may be provided as the number of channels. Each channel may have a joint assembly. For example, if a first channel and a second channel are provided, the first channel may be provided with a first engagement assembly, and the second channel may be provided with a second engagement assembly. The same number of joint assemblies and vessels can be provided.

8A-8B provide an example of a sample collection device 800 having channels 822a, 822b in fluid communication with the interior of vessels 846a, 846b within the device. The sample collection device may include a body 820 , a holder 830 and a base 840 . The body and/or the stand may support and/or contain at least a portion of one, two or more channels. The channel may extend beyond one end of the body. The base may support and/or contain one, two or more vessels.

In one embodiment, the body 820 and/or the holder 830 may support one or more channels 822a, 822b in the sample collection device. For example, a first channel and a second channel may be provided. Each channel can have a first end 823a, 823b that can be provided at a sample receiving end of the device that can extend beyond the body. The first end of each channel may be open. The channel may be open to ambient air. The channel may be rigid or may be flexible. In some embodiments, the channels may have a length that allows them to bend into contact with each other. When the first end of the channel contacts a fluid, such as blood, the fluid can be drawn into the channel. Each channel end can individually contact a fluid that can be drawn into the corresponding channel. This may involve adjusting the angle of the sample collection device so that only one opening in the access channel is in contact with the sample fluid at any one time. Alternatively, all channels can simultaneously contact the same sample, which is simultaneously drawn into the corresponding channels. Alternatively, multiple but not all channels may contact the same sample at the same time, which is then drawn into the corresponding channels simultaneously. The fluid may be drawn in via capillary action or any other technique described elsewhere herein. The fluid may travel along the length of the channel to a corresponding second end of the channel. In some embodiments, the fluid can reach the second end of the channel via capillary action or other techniques described herein. In other embodiments, the fluid need not reach the second end of the channel. The channels may be fluidly isolated from each other.

In some embodiments, when the channel is not in fluid communication with the interior of the vessel 846a, 846b, the fluid can pass to the second end of the channel without exiting. For example, fluid can be drawn into the channel via capillary action, which can cause the fluid to flow toward or near the end of the channel without causing the fluid to exit the channel.

The body 820 may be movable relative to the stand 830 during use of the device. In some embodiments, the body is slidable in the longitudinal direction relative to the support. In one example, the body may have (i) an extended position in which the channel is not in fluid communication with the interior of the vessel, and (ii) a compressed position in which the channel is in fluid communication with the interior of the vessel. The sample collection device may be initially provided in an extended state, as shown in FIG. 7 . After the sample has been collected and flowed through the length of the channel, the user can push in the body to provide the sample collection device in its compressed state, as shown in Figure 8 . In some cases, when the body is in the extended state, an interior portion of the body is exposed. The interior portion of the body may be covered by the stent when the body is in a compressed state. The flange of the body can contact the bracket. Once the body has been pushed in, the body may naturally remain pushed in, or it may spring back to an extended state once the pushing force is removed. In some cases, the body can be pulled out to an extended state, or can be pulled out completely to provide access to the vessel therein. Optionally, in some assemblies, removal of the body will not provide access to the vessel.

The base 840 can be connected to the holder 830 of the sample collection device. The base 840 may be capable of supporting one or more vessels 846a, 846b. The base can have a housing that can at least partially surround the one or more vessels. In some cases, when the base is engaged with the bracket 830, the vessel may be completely enclosed. The base may have one or more depressions, protrusions, grooves or shaped features to receive vessels. The base may be formed to have a shape complementary to the shape of the vessel. The vessel can be held in an upright position relative to the base.

The same number of vessels as the number of channels can be provided. Each channel may correspond to a corresponding vessel. In one example, the sample collection device may have first and second channels, and corresponding first and second vessels. The first channel 822a may be in fluid communication with the first vessel 846a or may be configured to be brought into fluid communication with the first vessel, and the second channel 822b may be in fluid communication with the second vessel 846b or may be configured to be brought into fluid communication with the first vessel 822b into fluid communication with the second vessel. The first channel may initially be out of fluid communication with the first vessel, and the second channel may be initially out of fluid communication with the second vessel. The first and second channels can be brought into fluid communication with the interior of the first vessel and the second vessel, respectively, when the body is pushed relative to the holder. The first channel and the second channel can be brought into fluid communication with the first vessel and the second vessel simultaneously. Alternatively, they need not be brought into fluid communication simultaneously. The timing of fluid communication may depend on the height of the vessel and/or the length of the channel. The timing of fluid communication may depend on the relative distance between the second end of the channel and the vessel.

In some embodiments, each vessel may have a body 849a, 849b and a cap 848a, 848b. The vessel body may have a tubular shape. In some cases, the vessel body may have a cylindrical portion. The bottom of the vessel may be flat, tapered, rounded, or any combination thereof. The vessel may include an open end and a closed end. The open end can be the top end of the vessel, which can be at the end of the vessel that is closer to the one or more channels. The closed end may be the bottom end of the vessel, which may be at the end of the vessel further away from the one or more channels. Variations and substitutions are possible for the embodiments described herein, and no single embodiment should be construed as encompassing the entire invention.

The bracket 830 may have one or more optical indicators, such as optical windows 832a, 832b. Optical windows may be positioned over portions of channels 822a, 822b. The optical window can provide an indication of whether the sample has reached and/or passed through the portion of the channel shown by the optical window. This can be used to assess whether the sample has flowed sufficiently for the user to push the body into the sample collection device. In some cases, it may be desirable for the sample to reach or near the second end of the channel before bringing the channel into fluid communication with the vessel. In some cases, the sample may need to reach a specific portion of the channel before being pushed into the body to bring the channel into fluid communication with the vessel. Certain portions of the channel may be located below the optical window.

Base 840 may have one or more optical indicators, such as optical windows 842a, 842b. Optical windows may be positioned over vessels 846a, 846b. In some cases, the optical window may be positioned over the vessel body. The optical window provides an indication of whether the sample has entered the vessel. The optical window shows how much sample has filled the vessel. This can be used to assess whether a sufficient amount of sample has entered the vessel. In some cases, it may be desirable for a certain amount of sample to enter the vessel before it is removed from fluid communication with the channel. A predetermined volume of sample in the vessel may be desired before the base of the device is removed to bring the vessel out of fluid communication with the channel.

The vessel and/or the interface to the channel may have any characteristics or characteristics, such as those described elsewhere herein. In some cases, the second end of the channel can penetrate the cap of the vessel, thereby bringing the channel into fluid communication with the vessel. In some cases, the channel can be withdrawn from the vessel, and the cap of the vessel can form a fluid-tight seal, allowing a fluid-tight environment within the vessel when the channel is brought out of fluid communication with the vessel.

One or more joint assemblies may be provided. The engagement assembly may include a channel retainer and/or a force applying component, such as a spring or rubber band. The retainer keeps the channel secured to the body. The retainer prevents the channel from sliding relative to the body. The retainer may optionally be provided with a bracket upon which a force-applying component such as a spring may rest.

In one example, the engagement assembly can include a spring that can apply a force such that when the spring is in its natural state, the body is in its extended state. A space may be provided between the vessels 846a, 846b and the bottom portion of the sample body 820 when the body is in its extended state. The second ends of the channels may be in positions where they are not in fluid communication with the interior of the vessel.

When pressed into the body, the spring 852 may be compressed (see also FIGS. 9A-9C ). The second end of the channel can penetrate the cap of the vessel. The second end of the channel can enter the interior of the vessel. In some cases, a force may be provided to drive fluid from the channel into the vessel. For example, a pressure differential can be created between the first end and the second end of the channel. Positive pressure may be provided at the first ends 823a, 823b of the channel and/or negative pressure may be provided at the second end of the channel. The positive pressure may be positive relative to the pressure of the air at the second end of the channel and/or surrounding air. The negative pressure may be negative relative to the pressure of the air at the first end of the channel and/or surrounding air. In one example, vessels 846a and 846b may each have a vacuum therein. When the second end of the channel penetrates the vessel, the negative pressure within the vessel can draw the sample into the vessel. In alternative embodiments, the sample may be driven into the vessel by capillary force, gravity, or any other power. Alternatively, there may be single or multiple combinations of forces to fill the vessel with fluid.

In some cases, different types of power can be used to draw the sample into the channel and from the channel into the vessel. For example, capillary force can draw the sample into the channel, while differential pressure can drive the sample from the channel into the vessel. Any combination of power can be used to aspirate the sample into the channel and into the vessel.

After the sample has been introduced into the channel, some time may elapse for the sample to travel the length of the channel. The user can introduce a sample into the sample collection device and can wait for the sample to travel the length of the channel. One or more optical indicators can be provided along the length of the channel, which can indicate whether the sample has reached the end of the channel. In other embodiments, the user may wait a predetermined amount of time before pushing the body. After the user has determined that the sample has traveled a sufficient length of the channel and/or that a sufficient amount of time has elapsed since the sample was introduced, the body can be pushed in. The body can have a flat surface that can be easily pushed by a user. In some cases, the flat surface may have a cross-sectional area that may be sufficient for a user's finger to press down on the body. After the body is pushed in, the channel can be brought into fluid communication with the vessel, and the sample can flow from the channel into the vessel. An optical indicator can be provided so that the user can know when the vessel is filled.

Once the vessel has been filled, it can be transferred to the desired location using the systems and methods described elsewhere herein. As previously described, the entire sample collection device can be transferred. In other embodiments, the base portion may be removable from the rest of the device. In one example, the base can be removed from the sample collection device, and the vessel can be transferred along with the base. Alternatively, the base can be removed from the sample collection device to provide access to the vessel, and the vessel can be removed and transported from the device.

Referring to Figures 9A-9B, an example of a sample collection device 900 and method of use will now be described. In one non-limiting example, the device may have a body 920 , a bracket 930 and a base 940 . The main body 920, the bracket 930 and the base 940 may be movable relative to each other. In some cases, various components of the device may be movable during different phases of use. Examples of stages of use may include when the device is in an extended state, a compressed state, and a disengaged state.

Figure 9A shows an example of the device 900 in an extended state. The body 920 is extendable relative to the stand. Channels 922a, 922b configured to transport the sample can be secured to the body. The first end of the channel may extend from the body and/or the remainder of the sample collection device. The second end of the channel may be located within or contained by a portion of the sample collection device. The channels can be fluidly isolated from corresponding vessels housed by the base 940 . Bracket 930 may be positioned between the body and the base. The stent may at least partially contain a portion of the channel. In some cases, the stent can include the second end of the channel.

When in the extended state, the device may have an extended length. The length of the device may be from the bottom of the base to the first end of the channel. Alternatively, the length of the device can be measured from the bottom of the base to the top of the body.

As seen in Figure 9A, the device 900 may be in an extended state when a sample is introduced into the device. For example, the sample can be contacted by at least the first end of the channel. The sample can be drawn into the channel via capillary action or any other technique or power described herein. The forces can act individually or in combination to draw the sample into the device. The device 900 can remain in an extended state while the sample is traversing the channel. The sample can fill the entire length of the channel, a portion of the channel length, or at least a minimum portion to meet the desired sample collection volume.

Figure 9B shows an example of the device 900 in a compressed state. The body 920 is compressible relative to the stent. Channels 922a, 922b may be secured to the body. The channels can be in fluid communication with their corresponding vessels. When the device is brought into a compressed state, the first channel can be brought into fluid communication with the interior of the first vessel, and the second channel can be brought into fluid communication with the interior of the second vessel.

By way of non-limiting example, the user may push the body 920 toward the bracket 930 (or vice versa) to bring the device to a compressed state. Relative motion between parts may involve movement of the two parts. Alternatively, moving may involve moving only one of them. In this example, the body 920 can be pushed all the way to the bracket 930 so that no interior portion of the body is exposed and/or the flange of the body contacts the bracket. Any detent mechanism that can engage when the device is fully compressed can be used. Alternatively, the body may be pushed only partially. For example, a portion of the interior portion of the body may be exposed. The bracket can be positioned between the main body and the base. The stent may at least partially contain a portion of the channel. In some cases, the second end of the channel can extend beyond the support of the device.

When in a compressed state, it should be understood that device 900 may have a compressed length. The length of the device 900 may be from the bottom of the base to the first end of the channel. Alternatively, the length of the device can be measured from the bottom of the base to the top of the body. The compressed length of the device may be less than the extended length of the device. In some embodiments, the compressed length of the device may be at least about 0.1 cm, 0.5 cm, 1.0 cm, 1.5 cm, 2.0 cm, 2.5 cm, 3.0 cm, 3.5 cm, 4.0 cm, or 5.0 cm less than the extended length of the device. The compressed length of the device may be less than or equal to about 50%, 60%, 70%, 75%, 80%, 85%, 90%, 95%, 97%, or 99% of the extended length of the device.

One or more engagement assemblies may be provided with device 900 . The engagement assembly may include a channel retainer 950 and/or a force applying component, such as a spring 952 or a rubber band. Retainer 950 may hold adapter channel 954 secured to the bracket. As will be described elsewhere herein, the adapter channel 954 may be integrally formed with the collection channel, or may be a discrete component, which may be a separate piece, part of the collection channel, or part of the vessel. In one embodiment, the retainer 950 can prevent the adapter channel 954 from sliding relative to the bracket. Retainer 950 may optionally provide a bracket upon which a force-applying component, such as a spring, may rest. When the device is in a compressed state, a force-applying component, such as a spring, may be in a compressed state. When the device is in a compressed state, the spring can apply a force to the body of the device.

The device may be in a compressed state when the sample is transferred from the channel to the corresponding vessel. In some examples, transfer can occur via a pressure differential between the channel and the vessel interior as they are brought into fluid communication. For example, the second end of the channel can be brought into fluid communication with the interior of the vessel. The vessel may have vacuum and/or negative pressure therein. When the channel is brought into fluid communication with the vacuum vessel, the sample can be drawn into the vessel. The device may remain compressed while the sample is being transferred to the vessel. The sample can fill the entire vessel or a portion of the vessel. The entire sample (and/or 90%, 95%, 97%, 98%, 99%, 99.5% or more of the sample) from the channel can be transferred to the vessel. Alternatively, only a portion of the sample from the channel can be transferred to the vessel.

Referring to Figure 9C, an example of the apparatus 900 in a detached state will now be described. Base 940 is detachable from the rest of device 900. Body 920 can expand or compress relative to bracket 930 . In one example, the extended state may be a natural state such that when the user no longer applies force to the body, the body may stretch back to the extended state. Channels 922a, 922b may be secured to the body.

When the device 900 is in the detached state, the base 940 can be detached from the stand 930 of the device. The channels 922a, 922b can be removed from fluid communication with their respective vessels 946a, 946b. When the device 900 is brought to the disengaged state, the first channel can be brought out of fluid communication with the interior of the first vessel, and the second channel can be brought out of fluid communication with the interior of the second vessel. This can happen sequentially or simultaneously. When the channel is removed from the vessel, the vessel may assume a sealed state to prevent unwanted material from entering the vessel. In some embodiments, the vessel may be fluid-tight after removal of the channel. Optionally, the vessel may be gas-tight after removal of the channel.

The user can detach the base 940 from the stand 930 to bring the device to a detached state to remove the vessel therein. In some embodiments, the base can be detached from the bracket, or vice versa. Detaching the base from the stand can expose vessels 946a, 946b supported by the base. The vessel may be press-fitted or otherwise retained within the base. The vessels 946a, 946b may be removable from the base. By way of non-limiting example, the removal of vessels 946a, 946b allows them to be placed with other vessels in a climate-controlled shipping container for transport to a receiving site, such as, but not limited to, an analysis site. Optionally, the vessels 946a, 946b may be removed to allow for pretreatment, such as, but not limited to, centrifugation, before being forwarded for processing at a receiving site, such as, but not limited to, an analytical site. Alternatively, the vessels 946a, 946b may remain with the base.

10A-10B provide additional views of the sample collection device 1000 in a separated state. When in the detached state, the base 1040 may be detached (partially or fully detached) from the stand 1030 and/or the body 1020 of the device. This allows vessels 1046a and 1046b to be removed through one end of base 1040 that was not previously exposed when device 1000 was not in a detached state.

One or more channels 1022a, 1022b may be fluidly isolated from one or more vessels 1046a, 1046b housed by base 1040 when the device is in the detached state. Vessels may be fluidly isolated from their environment. Vessels may contain therein a sample that has been transported through the collection channel, brought to a minimum fill level, and then substantially completely deposited into the corresponding vessel. The base 1040 may include one or more optical indicators 1046a, 1046b. The optical indicator can show a portion of the vessel within, so that the device 1000 is not moved to the detached state until a minimum fill level has been reached in the vessel. By way of non-limiting example, the vessel may have a light transmissive material that allows the user to view the sample within the vessel from outside the base.

In some embodiments, the base 1040 can contain at least a portion of the vessel. The base may have a hollow interior and walls surrounding the hollow interior. The base may have one or more shaped features that can support the vessel. Vessels may be provided within the hollow interior. The wall may surround the vessel. The base can have an open top through which the vessel can be exposed. Vessels may or may not be removed through the open top.

Collection device with multiple collection channels

Referring to Figures 11A-11F, further embodiments as described herein will now be described. This embodiment provides a bodily fluid sample collection device 1100 for collecting fluid samples that may be pooled or otherwise formed on a surface such as, but not limited to, a subject's skin or other target area. Although the present embodiment shows a device body having at least two collection channels of different volumes defined therein, it should be understood that devices with fewer or greater numbers of collection channels are not excluded. Embodiments using the same collection volume for one or more channels are also not excluded. Variations and substitutions are possible for the embodiments described herein, and no single embodiment should be construed as encompassing the entire invention.

Figure 11A illustrates a perspective view of one embodiment of a bodily fluid sample collection device 1100 having a distal end 1102 configured to engage a fluid sample on a surface. In this embodiment, the distal end 1102 may have a configuration designed to better engage a droplet or pool of bodily fluid or sample formed on a surface. In addition to the desired shape, some embodiments may have surface treatments at the distal end 1102 , such as, but not limited to, chemical treatments, textures, surface features, or coatings to facilitate fluid flow toward the distal end 1102 , to the device 1100 . One or more openings 1104 and 1106 of the channel in the flow.

As seen in Figure 11A, this embodiment of the sample collection device 1100 may have two openings 1104 and 1106 for receiving sample fluid. It should be understood that some embodiments may have more than two openings at the distal end. Some embodiments may have only one opening at the distal end. Optionally, some embodiments may have additional openings along a side or other surface leading away from the distal end 1102 of the device 1100. Openings 1104 and 1106 may have any cross-sectional shape. In some non-limiting examples, the opening may have a circular, oval, triangular, quadrilateral (eg, square, rectangular, trapezoidal), pentagonal, hexagonal, octagonal, or any other cross-sectional shape. The cross-sectional shape may remain the same or may vary along the length of the collection device body. In some cases, the opening may have a cross-sectional area of less than or equal to about 2 mm ² , 1.5 mm ² , 1 mm ² , 0.8 mm ² , 0.5 mm ² , 0.3 mm ² , or 0.1 mm ² . Some embodiments may have openings of the same shape. Other embodiments may use different shapes for one or more openings.

Sample filling portion 1120 may be the body of sample collection device 1100, which may be formed of a transparent and/or translucent material that enables a user to see whether a sample has entered one or more sample collection channels in sample filling portion 1120 ( See Figure 11B). In some embodiments, the entire sample filling portion 1120 is transparent or translucent. Alternatively, some embodiments may make only all regions on the channel or only selected portions of the channel or sample filling portion 1120 transparent or translucent to allow the user to see the filling of the sample into the sample collection device 1100. Optionally, the sample fill portion is made of an opaque material, but has openings or windows to allow visualization of fill levels therein. Device 1100 may further include one or more visualization windows 1112 and 1114 to allow a user to see when a desired fill level has been achieved. The visualization window may be formed of transparent and/or translucent material. Alternatively, the visualization window can be an opening without any material in it. Additional visualization windows can also be used to determine that all fluid in the collection channel has been emptied into vessels 1146a and 1146b (see Figure 11B).

11A also shows that some embodiments of the stand 1130 may have optical windows 1132 and 1134 positioned to show the fill level in the vessels 1146a and 1146b, thereby showing whether the vessel in the base 1140 has been moved to the location for receiving the sample fluid. Alternatively, windows 1132 and 1134 may be cutouts that act as guides for snap features of the base to define start and end positions during activation. It should be appreciated that the base may be configured to hold one or more sample vessels. By way of example and not limitation, the entire base 1140 may be removed from the sample collection device before or after sample filling. The base 1140 can be used as a holder to retain the sample vessel therein during shipping, and in such an embodiment, the base 1140 would be loaded into a shipping tray or other holder for shipping along with the sample vessel . Alternatively, some embodiments may remove the sample vessels from the base 1140 and then transport the vessels without the base 1140 holding them.

Figure 11B shows a cross-sectional view along section line B-B of the embodiment shown in Figure 11C. FIG. 11B shows channels 1126 and 1128 in section 1120 . The sample filling portion 1120 may be formed from two or more pieces joined together to define the portion 1120. Some embodiments may define the channel in one piece and then have another piece that cooperates with the first piece to define opposing wall or top wall surfaces of the channel. In terms of manufacture, this allows one part to have a channel moulded or otherwise formed in the body, and the opposing part will cooperate to act as a covering for, or may also include parts of, the channel. Channels 1126 and 1128 may be formed only in portion 1120, or may also extend into bracket 1130, which has features for connection with vessels held in base or carrier 1140. Some embodiments may have portion 1120 and portion 1130 integrally formed together. The bracket 1130 can also be configured to hold an adapter channel 1150 that will fluidly connect the channels 1126 and 1128 with their respective vessels 1146a and 1146b.

Although the embodiments herein are described as using two channels and two vessels, it should be understood that other numbers of channels and vessels are not excluded. Some embodiments may have more channels than vessels, some of which will be coupled to the same vessel. Some embodiments may have more vessels than channels, in which case multiple vessels may be operably coupled to the same channel.

As seen in Figure 11B, channels 1126 and 1128 may be of different sizes. This allows a different volume of fluid to be collected in each channel before it is transferred into vessels 1146a and 1146b simultaneously. Alternatively, some embodiments may have channels 1126 and 1128 sized to contain the same volume of fluid. In some embodiments, the fluid paths of channels 1126 and 1128 are shaped and/or angled so that the openings near the distal end 1102 are closer to each other than the proximal end, and the openings may be further spaced to align them with into vessels 1146a and 1146b. Variations and substitutions are possible for the embodiments described herein, and no single embodiment should be construed as encompassing the entire invention.

11B also shows that some embodiments may use needles for adapter channels 1150 and 1152 in body 1130 that communicate with channels 1126 and 1128. The needles each have a channel to allow fluid to pass therethrough from collection channels 1126 and 1128 to the tip of the needle. As seen in FIG. 11B, vessels 1146a and 1146b in base 1140 can slide relative to stand 1130, as indicated by arrow 1156. Relative movement between the bracket 1130 and the base 1140 can reduce the gap 1154 . Closing the gap 1154 brings the adapter channel 1150 into the cap 1148a of the vessel 1146a until there is fluid communication between the interior of the vessel 1146a and the collection channel 1126. At this point, pro forma power will then move the fluid in channel 1126 into vessel 1146a.

By way of example and not limitation, any combination of powers can be used to aspirate the sample into the vessel. Some embodiments may use the pulling force from the vacuum in the vessel 1146a to draw the sample into the vessel. Some embodiments may use thrust from external pressure to move fluid into the vessel. Some embodiments may use both forces simultaneously. Some embodiments may rely on capillary forces and/or gravity. In some embodiments, the one or more powers used to draw the sample into the channel are different from the one or more powers used to draw the sample into the vessel. In some alternative embodiments, the one or more powers may be the same for each stage. In some embodiments, the one or more powers are applied sequentially or for a defined period of time. By way of non-limiting example, the power or forces to draw the sample into the vessel are not applied until at least one channel has reached a minimum fill level. Optionally, the power or powers to draw the sample into the vessel are not applied until at least two channels have each reached a minimum fill level for that channel. Optionally, the power or powers to draw the sample into the vessel are not applied until all channels have each reached the minimum fill level for that channel. In some embodiments, one or more powers are applied simultaneously. These enumerated features may apply to any of the embodiments herein.

Referring now to FIG. 11E, an enlarged cross-sectional view of device 1100 is shown. This embodiment shows that the bracket 1130 has a flange portion 1136 sized to extend over the adapter channels 1150 and 1152 a sufficient amount to prevent a user from inserting a finger into the gap 1154 and the needle A finger pricked on one of them.

Furthermore, as shown in Figures 11B and 11E, the present embodiment has at least two channels in the sample collection device 1100. This allows each of channels 1128 and 1126 to introduce a different material into the sample. By way of non-limiting example, if the sample is whole blood, one channel may introduce heparin into the blood and the other channel may introduce ethylenediaminetetraacetic acid (EDTA). These anticoagulants not only prevent premature blockage of the channels during filling, but also introduce anticoagulants into the whole blood in preparation for transport in vessels 1146a and 1146b. Optionally, one or more channels may be plasma coated in addition to or in lieu of anticoagulant. The plasma coating reduces the flow resistance of the bodily fluid sample in the channel. Such coatings may be applied in a pattern such as, but not limited to, strips, rings, or other patterns along with any other coating or coatings to be used in the channel.

Optionally, a sufficient amount of anticoagulant is present in the respective channel such that the sample fluid will contain the desired level of anticoagulant in the sample fluid after only a single passage of the fluid through the channel. In traditional blood vials, the blood sample does not contain anticoagulant until it enters the vial, and once in the vial, the technician typically repeatedly tilts, shakes and/or agitates the vial to allow the anticoagulant in the vial to mix. In this embodiment, the sample fluid will contain the anticoagulant before entering the sample vessel, and it will do so without repeatedly tilting or agitating the sample collection device. In embodiments herein, a single pass provides sufficient time and sufficient concentration of additives, such as anticoagulants, into the sample fluid. In one embodiment, the EDTA channel has a volume of 54 uL, coated with 200 mg/mL EDTA; the heparin channel has a volume of about 22 uL, coated with 250 units/mL of heparin. In another embodiment, the EDTA channel has a volume of 70 uL and is coated with 300 mg/mL of EDTA; the heparin channel has a volume of about 30 uL and is coated with 250 units/mL of heparin. By way of non-limiting example, channels with volumes from 50 uL to 70 uL can be coated with EDTA ranging from about 200 mg/mL to 300 mg/mL of EDTA. Alternatively, channels with volumes from 70 uL to 100 uL can be coated with EDTA ranging from about 300 mg/mL to 450 mg/mL EDTA. Optionally, channels with volumes from 20uL to 30uL can be coated with heparin ranging from 250 units/mL of heparin. For example, the material can be a solution that is coated on the target surface for less than 1 hour and then dried overnight. Variations and substitutions are possible for the embodiments described herein, and no single embodiment should be construed as encompassing the entire invention.

Referring to Figure 11G, further embodiments will now be described. The embodiment of Figure 11G shows that at the distal end 1202 of the sample collection device 1200, the sample collection device 1200 combines two or more channels into a single channel, rather than having one opening 1204 for each channel. The embodiment of Figure 11G shows that the common channel portion exists before the common channel is divided into separate channels. As will be described below in Figure 11I, there may optionally be backflow preventers, such as, but not limited to, drain holes positioned along separate channels to reduce filling and flow of sample from the channels into the one or more vessels. /or the possibility of aspirating sample from one channel to another during draw.

As seen in Figure 11H, the use of such a common flow path can result in a reduced number of openings on the exterior of the sample collection device 1200, which can be aligned with the openings 1204 to engage the bodily fluid sample. It can also increase the capillary force used to draw the bodily fluid sample into the sample collection device 1200 by having more capillaries pulled on the same channel that the bodily fluid sample enters the collection device.

Referring to Figure 11I, a cross-sectional view of selected components of the sample collection device will now be described. Figure 11I shows that the sample collection device can have two channels 1182 and 1184 with a common portion 1186 leading to an inlet opening on the device. In some embodiments, common portion 1186 is a continuation of one of channels 1182 or 1184 in size, shape, and/or orientation. Optionally, common portion 1186 is not the same size, shape and/or orientation as any of passages 1182, 1184, or any other passages that may be in fluid communication with common portion 1186. FIG. 11I shows that in one non-limiting example, a baffle may be present at the interface 1188 between the channels 1182 and 1184 . The interface 1188 can be configured to ensure flow into both channels so that they will both reach full filling. In one embodiment, the interface 1188 has a larger dimension than the channel 1182 leading away from the interface 1188. Although other sizes are not excluded, a larger size of this port 1188 ensures that sufficient flow will enter passage 1182, which in this embodiment has a smaller diameter and reduced volume relative to passage 1184. Variations and substitutions are possible for the embodiments described herein, and no single embodiment should be construed as encompassing the entire invention.

Figure 11I also shows that there may be vent holes 1190 and 1192, which may be used to prevent cross flow between the channels, especially when the sample is being transferred into the sample vessel. In one embodiment, the vent holes 1190 and 1192 are always open. In another embodiment, the vent holes 1190 and 1192 may only be open at selected times, such as, but not limited to, after the channels 1182 and 1184 are filled or substantially filled. Some embodiments may plug the vent holes 1190 and 1192 with a dissolvable material until they come into contact with the sample fluid. Alternatively, some embodiments may use a slidable cover to cover one or more of the drain holes 1190 and 1192 so that they are only open at times selected by the user. In one embodiment, the cover is attached to the sample vessel such that movement of the sample vessel to move into fluid communication with the channel will also open one or more vent holes 1190 and 1192 to reduce cross flow between the channels risk. Alternatively, other anti-cross-flow mechanisms, such as, but not limited to, valves, gates, or plugs, may also be used to prevent fluid transfer between channels 1190 and 1192.

FIG. 11I also shows that there may be a leak containment device 1194 positioned over adapters 1150 and 1152. In this embodiment, the leak-prevention devices 1194 are frits that can be slidably moved from a first position in which they prevent the sample from leaking out of the adapters 1150 and 1152 to where they allow the adapters to deliver fluid into the sample vessel the second position. In one non-limiting example, the leak prevention device 1194 will slide when it is engaged by the sample vessel or the housing containing the sample vessel. Movement of the sample vessel or housing in this non-limiting example shows that movement of these elements will also result in movement of the containment device 1194.

Referring to Figure 11J, yet another embodiment of a sample collection device 1160 will now be described. This embodiment of the sample collection device 1160 shows the device 1160 having a sample entry location 1204 that leads to a plurality of channels 1162 and 1164 in the device 1160. Although FIG. 11J shows that channels 1162 and 1164 may have different shapes and/or sizes, some embodiments may be configured to have the same volume and/or shape. It should also be understood that the sample entry location 1204 may be on the surface of the device 1160, or alternatively, it may be part of a tip, nozzle, shaft end, or other protrusion extending from the body of the device 1160. The protrusion may be in the same plane as and aligned parallel to the body of the device, or alternatively, it may be angled such that the axis of the protrusion intersects the plane of the device 1160.

11J further shows that for some embodiments, sample flow features 1166 and 1168 may be present to aspirate or otherwise preferentially direct the sample in a desired direction. In some embodiments, features 1166 and 1168 are rails that operate to reduce channel dimensions (such as, but not limited to, width or height) in at least one axis, and thereby increase capillary action through those areas of reduced size. In one non-limiting example, these flow features 1166 and 1168 may assist fluid flow through the region of the channel located near the anti-cross flow feature 1170 during the entry of the sample into the channel. In one embodiment, flow features 1166 and 1168 are sized to preferentially improve flow in the inward direction when the flow is drawn primarily by capillary action. In one case, the outward flow is not based on capillary forces, but on vacuum pull forces (such as pull forces from adjacent channels), and the flow features 1166 and 1168 of this embodiment are not configured for use in those vacuum, non- Provides assistance under capillary flow conditions. Accordingly, some but not all embodiments of flow features 1166 and 1168 are configured to assist under at least one type of flow condition but not some other flow condition or conditions. Alternatively, some embodiments may use other techniques, such as, but not limited to, shaped features, one or more hydrophobic materials, one or more hydrophilic materials, or other techniques, alone or in combination with the rails, to orient Push/pull the sample in the desired direction.

FIG. 11J also shows that in one or more embodiments herein, there are angled sidewall features 1167 that conically or otherwise vary the cross-sectional area of the channel in a manner that brings the sample together. Narrow to minimize the amount of sample that can remain in the channel without being collected. Figure 11J also shows that one or more locating features 1169 may be present to assist in joining the components together in a defined location and orientation during manufacture.

FIG. 11K shows a side view of this embodiment of the sample collection device 1160 . The side view of device 1160 shows the presence of an embodiment in which one or more anti-cross flow features 1170 (such as, but not limited to, drain holes) are present to allow undesired sample crossover between channels 1162 and 1164 Flow is minimized, especially when the desired fill level has been reached in the respective channel. Anti-cross flow features 1170 and 1172 prevent cross flow due to the interruption in the fluid path created by the vent holes. The cross flow problem itself most often occurs when the vessel in holder 1140 is engaged and provides additional power to pull the sample from the channel into the vessel. Such a "pull" effect may inadvertently draw sample from one channel to an adjacent channel. To minimize cross-flow, the forces associated with pulling the sample from the channel into the vessel will pull from the fluid in the drain hole rather than the adjacent channel, thereby minimizing undesired mixing of the sample.

11K also shows that in some embodiments herein, there are common portions 1130 and 1140 that may be adapted for use with different sample filling portions 1120. Some embodiments may use different capillary fill portions 1120. Some embodiments may use filler portions that use different types of capture techniques, such as, but not limited to, samples collected from venous blood draws, arterial blood draws, or drawn from internal or target sites in the subject of other samples.

Referring now to Figure 11L, one embodiment of sample flow features 1166 and 1168 is shown. This cross-sectional view of the sample collection portion with channels 1162 and 1164 and sample flow features 1166 and 1168 near the common inlet passage 1165 shows that in one embodiment, the features are desired near where the sample enters the channel . 11L also shows that for channels of different volumes, it may be desirable to locate the inlet 1165 closer to the channel 1164 having a larger volume, as seen by the asymmetrical position of the inlet 1165. It can also be seen in some embodiments that one or more locations of the sample flow features 1166 and 1168 can also be selected to control the fill rate, fill volume, etc. in the sample collection device 1160. It will be appreciated that one or more of the described features may be adapted for use with other embodiments herein.

Referring now to Figure 11M, channels 1162 and 1164 with sample cross-flow prevention features are shown. In one embodiment, the sample anti-cross-flow features are vent holes 1170 and 1172 on at least one surface of channels 1162 and 1164. In one non-limiting example, these sample anti-cross flow features are located near any sample flow features 1166 and 1168 in the device. In one embodiment, these anti-cross flow features are configured to prevent flow between channels. These anti-cross-flow features can be located near the maximum fill position of each channel, such that when the channel is at or near its maximum sample capacity, the anti-cross-flow features 1170 and 1172 are positioned to prevent overfilled sample from causing The processed sample in one channel enters the other channel and undesirably mixes the samples from both channels together.

11N shows a perspective view of sample collection device 1160 with sample fill indicators 1112 and 1114. In one embodiment, these indicators 1112 and 1114 are openings or transparent portions of device 1160 that allow viewing of at least a portion of one or more channels 1162 or 1164. When the sample is visible in at least one of indicators 1112 and 1114, it provides a prompt to the user to then take another action, such as, but not limited to, engaging a sample vessel in holder 1140. In some embodiments, there is only one sample filling indicator, which is a surrogate for sufficient filling of the sample in two or more channels. In some embodiments, action is taken to engage the sample vessel only when indicated by indicators 1112 and 1114. In some embodiments, action is taken to engage the sample vessel only when indicated by only one of the indicators.

Referring now to Figures 11O, 11P and 11Q, cross-sections at various locations along one embodiment of the device 1160 in Figure 11J are shown. Figure 110 shows a cross-section showing sample flow characteristics 1166 and 1168. Anti-cross flow features 1170 and 1172 are also shown. Engagement features 1174 may also be provided to enable the parts to be mated together to form the device 160.

Figure 11P shows the positioning of adapter channels 1150 and 1152 to extend into or at least in fluid communication with sample channels 1162 and 1164. Optionally, some embodiments may have a multi-lumen adapter channel 1150 or 1152. Optionally, some embodiments may have multiple adapter channels per sample channel, wherein such additional channels may be parallel to each other, angled to each other, wrap around each other, or otherwise oriented relative to each other.

11Q shows that in some embodiments, vessel holder 1140 may be asymmetrically shaped (in cross-section) or otherwise shaped so that holder 1140 can only be received in device 1160 in one orientation. This may be particularly desirable when it is desired to direct a sample from a certain channel into a selected channel. If the holder 1140 can be inserted in various orientations, the sample from one channel may end up in the wrong vessel. Optionally, other features, such as alignment features, grooves, visual cues, texture cues, etc., may be used to facilitate preferred orientation of the sample vessel in the device.

Integrated tissue penetrating components

Referring to Figure 11R, yet another embodiment of a sample collection device will now be described. The sample collection device 1210 includes features similar to those shown in FIG. 11G except that it also includes a tissue penetrating member 1212 mounted to the sample collection device 1210. The tissue penetrating member can be fired using an actuation mechanism 1214, such as, but not limited to, a spring actuator. Figure 11R shows the actuation mechanism 1214 in a standby state, and shows that it may be a spring that can be compressed to launch the tissue penetrating member 1212 toward the target tissue. Tissue penetrating member 1212 may be housed within housing 1216 (shown in phantom). In one embodiment, the housing 1216 includes a portion that can be peeled, pierced, released, or otherwise opened to allow the tissue penetrating member 1212 to exit the housing but also keep the tissue penetrating member 1212 free prior to its use. Bacterial. In some embodiments, the portion may be a foil, cap, polymer layer, or the like. Variations and substitutions are possible for the embodiments described herein, and no single embodiment should be construed as encompassing the entire invention.

In one embodiment, the tissue penetrating member 1212 path can be controlled to be both "normal" (ie, the forward direction of the tissue penetrating member) and "orthogonal" (ie, perpendicular to the main motion vector) along the trajectory . Some embodiments may not have a hard stop or abrupt stop at the deepest point of penetration (i.e., the point of return), which is a major cause of spontaneous pain. Some embodiments may use cushions, cam channels, or other non-hard stop mechanisms to prevent pain associated with shock waves that stop suddenly. Such shock waves are detrimental even if the tissue penetrating member successfully avoids striking nerves near the site of the wound because the shock waves can activate such nerves even if direct contact is avoided. Optionally, some embodiments may have tissue penetrating members that follow a non-shaking path to prevent rough wound passages (residual pain). This may be achieved in some embodiments by tighter tolerances in any guide passages used with the tissue penetrating member or pins associated with the tissue penetrating member. This can be a non-jitter path when penetrating tissue. Alternatively, this may be a non-vibrating path for the tissue penetrating member when it is outside the tissue and when it is inside the tissue. This can reduce the overall motion "rocking" of the tissue penetrating member that can lead to residual pain, lasting trauma and scarring.

Some embodiments may have a controlled outward velocity to prevent slow and delayed wound closure and postoperative bleeding. By way of non-limiting example, the controlled outward velocity of the tissue penetrating member may be controlled by a mechanical mechanism such as, but not limited to, a cam or higher friction material.

Some embodiments may also include an anti-bounce mechanism to prevent accidental re-pricking that may be associated with uncontrolled tissue penetrating members that rebound into tissue after an initial wound is created. Some embodiments herein may have a "parking" or locking mechanism that will engage the tissue penetrating member or its attachment to prevent the tissue penetrating member once it is retracted from the tissue or any other Re-entry when desired distance.

The sharpness with which the lancet stops at maximum depth in the skin before it begins its outward movement and returns to its starting position is an inherent problem in this design. The greatest amount of force is applied to the skin when the lancet is at the deepest point of its penetration. The drive mechanism simply bounces off the end of the unit like a ball bounces off the floor. The lancet, which comes to a sudden stop at the end of its inward motion, transmits a shock wave into the skin, causing the firing of many pain receptors near the lancet, even though they are not directly impacted. This greatly magnifies spontaneous pain.

As previously mentioned, some embodiments may use mechanical cam actuation in place of simple spring actuated tissue penetrating members. A device with a cam actuated design can minimize "hard stops" of the tissue penetrating member. Cam mechanisms are usually spring actuated and generally provide better lead actuation. The trajectory of the tissue penetrating member is tightly controlled to a guided path through the tissue penetrating member holder via pins riding in the cams. The cam mechanism allows for a predetermined speed profile with a softer return and explicit speed control of the outward trajectory of the tissue penetrating member. The mechanism also effectively avoids recoil of the lancet into the skin when the mechanism reaches its end point of motion. In addition, mechanical oscillation (or jitter/wobble) of the lancet path is reduced in both directions when fired in air. Some embodiments herein may also minimize any mechanical wobble of the drive mechanism (eg, due to uneven or rough cam grooves) to prevent such drive mechanism wobble from being transmitted directly to the in the organization.

Alternatively, some embodiments may use electronic actuation through an electronically controlled drive mechanism. This technique uses miniaturized electronic motors (e.g., voice coils, solenoids) coupled with very accurate position sensors to move tissue-penetrating members in and out of the skin in precisely controlled motion and velocity. After rapid entry, the device decelerates the tissue penetrating member to an accurate, preset depth for a smooth, jitter-free, and relatively slow return. This allows rapid wound closure and avoids long-term trauma. With this device, the force required to penetrate the lancet into the skin is controlled as the tissue penetrating member is advanced. The benefit of the tightly controlled "curve" of tissue penetrating member actuation is reproducible, painless blood collection that yields a sufficient and consistent blood sample for detection.

For puncture site creation for blood sample draw, it may be desirable to select a suitable puncture site on a finger (ring or middle finger) on the patient's non-dominant hand. The puncture site can be on the side of the fingertip of the finger. In one non-limiting example, it may be desirable to hold the hand warmer against the patient's selected finger for 15 seconds. Optionally, some embodiments may warm one or more fingers of the patient for from 10 to 60 seconds. Other embodiments may warm the fingers for longer periods of time. This warmth will increase blood flow to the target site. To prepare the target site, it may be desirable to wipe the lateral tip of the selected finger or the surface of the subject with an alcohol wipe or similar cleanser to ensure that the selected puncture site is wiped. In some embodiments, it is desirable to wait until the skin is completely dry. Generally, do not use gauze or blow air on your fingertips to speed up drying.

After the puncture has been made, keep the fingers down, below the patient's waist, to allow blood flow. Gently massage your fingers from base to tip until blood droplets form. The blood collection device was carefully filled by touching the tip of the device to the bead of blood on the finger. Make sure the unit is completely filled. Once the blood collection device is filled, press the bleeding area of the finger against the gauze pad on the table. Transfer the blood sample to a collection vessel. Put a bandage on your finger. Place the vessel with the sample into the shipping box in the refrigerator. Discard all supplies into biohazard sharps containers. All supplies are for single use only.

If sufficient blood is not obtained from the first puncture, carefully place the blood collection device on the table surface, making sure the device is level. Put a bandage on the pierced finger. Choose the appropriate puncture site on different fingers on the same hand of the patient. If the ring finger was pierced first, a new piercing site was selected on the middle finger and vice versa. Hold the hand warmer against the patient's selected finger for 60 seconds. Optionally, some embodiments may warm one or more fingers of the patient for from 30 to 90 seconds. This will increase blood flow to the finger. These techniques for blood collection using a sample collection device, such as any of the sample collection devices herein, can support adequate sample collection of capillary blood for use in Clinical Laboratory Improvement Amendments (CLIA) certified facilities and /or laboratory testing under standard.

Referring to Figure 11S, yet another embodiment of a sample collection device 1220 will now be described. In this embodiment, the tissue penetrating member 1222 may be mounted at an angle relative to the sample collection device 1220. This angled configuration allows the tissue penetrating member to create a wound in alignment with one or more of the sample collection openings 1103 and 1105. Although a standard spring fired actuator is shown as the drive mechanism 1224 for the tissue penetrating member 1222, it should be understood that a cam and/or electric drive system may also be used in place of or in combination with a spring fired actuator. When the drive mechanism 1224 is a spring, the spring can be compressed to move the tissue penetrating member 1222 to the firing position and released to penetrate the target tissue. Figure 11S shows the tissue penetrating member 1222 in a standby position. Although the figures show a spring for the drive mechanism 1224, it should be understood that other drive mechanisms suitable for firing a tissue penetrating member to create a healable wound in a subject are not excluded. Variations and substitutions are possible for the embodiments described herein, and no single embodiment should be construed as encompassing the entire invention.

Shell 1226 may be formed around tissue penetrating member 1222 similar to that described for shell 1216. Although Figure 11S shows two tissue penetrating members 1222 mounted on the sample collection device, it should be understood that devices with more or fewer tissue penetrating members are not excluded. For example, some embodiments may have only one tissue penetrating member 1222 mounted to the sample collection device 1220. Variations and substitutions are possible for the embodiments described herein, and no single embodiment should be construed as encompassing the entire invention.

Referring to Figure 11T, another embodiment of a sample collection device 1230 will now be described. This embodiment shows that the tissue penetrating member 1232 is contained within the sample collection device 1230 and, as seen in Figure 11T, is substantially coaxially aligned with the central axis of the sample collection device. This positions the tissue penetrating member 1232 for extending outwardly from the sample collection device 1230 at a location proximate to where the openings 1103 and 1105 are positioned on the sample collection device 1230. Of course, devices with more or less openings are not excluded, and the embodiment of FIG. 11T is exemplary and non-limiting. FIG. 11T shows that in one embodiment of the sample collection device, a firing button 1234 may be mounted on the sample collection device 1230. Optionally, some embodiments may have a shaped front end 1236 that functions as an actuation button, wherein when tissue is pressed onto the front end 1236 to a certain depth and/or a certain pressure, the tissue penetrating member will is actuated.

Once fired, tissue penetrating member 1232 moves as indicated by arrow 1233. In some embodiments, tissue penetrating member 1232 is fully contained within sample collection device 1230 prior to actuation. Some embodiments may have a visual indicator 1235 on the device 1230 to help guide the user as to where the tissue penetrating member 1232 will exit the device and generally where a wound will be formed.

In this non-limiting example, the entire device 1230 may be in a sterile bag or package that is opened only before the device 1230 is used. In this manner, sterile conditions can be maintained for the tissue penetrating member and collection device prior to use. Such an outer sterile bag or package may also be suitable for use with any of the other embodiments herein. Figure 11L also shows a shaped front end 1236 (shown in phantom), which may be integrally formed or separately attachable to the sample collection device 1230. Such a shaped front end 1236 can provide suction to draw sample fluid into the sample collection device 1230. Optionally, the shaping tip 1236 can be used to stretch and/or force the target tissue into the shaping tip to apply pressure to increase the amount of sample fluid from the wound formed by the sample penetrating member 1232. It should be understood that any of the embodiments herein may be adapted to have a shaped front end 1236. Optionally, the shaped tip may have one or more selected hydrophobic regions to direct sample fluid toward one or more collection regions on the tip. Optionally, the shaped tip may have one or more selected hydrophilic regions to direct sample fluid toward one or more collection regions on the tip.

Referring to Figure 11U, yet another embodiment of a sample collection device will now be described. This embodiment is similar to the embodiment of Figure 11T, except that the embodiment of Figure 11T uses multiple tissue penetrating members 1242 rather than a single tissue penetrating member such as a lancet. In one embodiment, these tissue penetrating members are microneedles 1242 having a reduced diameter compared to conventional lancets. Multiple microneedles 1242 can be actuated simultaneously for device 1240 and create multiple wound sites on tissue. The spacing of the microneedles 1242 can result in more capillary loops being pierced and more channels available for blood to reach the tissue surface. This also allows for a more "square" penetration profile compared to lancets with sharp tips and tapered profiles. This enables the microneedles 1242 to engage more capillary loops over a larger area without penetrating too deeply into deeper tissue layers where nerve endings are more densely packed.

Referring to Figures 11V and 11W, further embodiments of the sample collection device will now be described. In the embodiments shown in these figures, the sample collection device 1100 may be mounted at an angle to a dedicated wound creation device 1250 having tissue penetration configured to extend outwardly from the device 1250 Member 1252. The sample collection device 1100 can optionally be configured with a shaped front end 1236 (with or without an opening to accommodate the tissue penetrating member 1252), which can be removably mounted to the wound creation device 1250. Alternatively, sample collection device 1100 may be mounted flat to device 1250. Optionally, there may be shaped cutouts on the device 1250 for press fit retaining the sample collection device 1100. It should be understood that other techniques for removably mounting the sample collection device 1100 are not excluded. Such decoupling of the collection device from the wound creation device allows the use of a more complex, possibly non-disposable, wound creation device 1250 that can create a more controlled, less painful wound creation experience.

Figure 11W shows that the sample collection device 1100 may be aligned approximately horizontally to remain neutral with respect to the gravitational effect on sample collection. Other mounting configurations of the device 1100 to the wound creation device 1250 are not excluded.

Referring to Figures 11X-11Z, further embodiments of various sample collection devices will now be described. 11X shows a sample collection device 1240 in which a shaped front end 1236 can be used with the device 1240. The shaped front end 1236 is similar to the previously described shaped front end. Vacuum source 1270 may be used to assist in drawing a bodily fluid sample into device 1240. The vacuum source 1270 may be attached to the body of the device 1240 and/or to the shaping front end 1236. It should be understood that any of the embodiments described in this disclosure may be adapted for use with sample acquisition aids such as, but not limited to, vacuum source 1270.

Figure 11Y shows yet another embodiment of a sample collection device. This embodiment uses a pipette system with a tip 1280 for collecting sample fluid. The tip may include a coaxially mounted tissue penetrating member 1282. Optionally, a side mounted or angled tissue penetrating member 1284 is shown to create a wound at the target site. A pipette system with tip 1280 can apply a vacuum to pull sample fluid from a subject. Optionally, the shaping tip 1236 can be used with the tip 1280 to assist in skin stretching or tissue remodeling at the target site.

Figure 11Z shows that some embodiments may use an actuation mechanism attached to the diaphragm 1291 to create a vacuum for drawing a blood sample. Such attachment allows the septum to create a vacuum on the return of the tissue penetrating member 1292 from the target site. In one embodiment, the tissue penetrating member 1292 is a microneedle. Actuation of the tissue penetrating member fires the tissue penetrating member 1292 as indicated by arrow 1294 and creates a vacuum on the return path due to the movement of the septum linked to the movement of the tissue penetrating member 1292. One or more vessels 1296 may be coupled to contain fluid collected by device 1290. Some embodiments may have only one vessel 1296. Some embodiments may have a set of vessels 1296. Some embodiments may have multiple sets of vessels 1296. Some embodiments may be externally mounted on device 1290. Some embodiments may be internally mounted in device 1290. Variations and substitutions are possible for the embodiments described herein, and no single embodiment should be construed as encompassing the entire invention.

Vertical outflow restrictor

11E also more clearly shows the presence of sleeve 1156 around adapters 1150 and 1152. Although only shown in Figures 11A-11F, it should be understood that a sleeve with or without a vent hole may be configured for use with any of the embodiments contemplated herein. As seen in the embodiment of Figure 1 IE, the channel may be defined by the needle. These sleeves 1156 prevent premature flow of fluid sample from adapter channels 1150 and 1152 before vessels 1146a and 1146b engage the needles. Due to the small volume of sample fluid collected, preventing premature flow reduces the amount of fluid loss associated with transfer of fluid from the channel to the vessel. In one embodiment, the sleeve 1156 can minimize fluid loss by providing a liquid impermeable but not air impermeable sleeve. If the sleeve is air-tight, it may prevent the capillary action of the channel from functioning properly. Alternatively, some embodiments may locate the vent near the base of the needle, away from the tip, so that the sleeve may contain the sample at a location remote from the vent.

FIG. 11F shows that in an exemplary embodiment, the sleeve 1156 is configured with an opening 1158 therethrough. This provides an improved embodiment compared to conventional sleeves that typically fit loosely over the needle. Due to the loose fit, in conventional sleeves, there is sleeve space in the tip and in the sidewall space between the needle and the sleeve in which the fluid sample can accumulate. Although a sleeve designed in this way can help prevent larger losses of fluid by limiting the loss to a limited amount compared to a needle without a sleeve that may continuously lose fluid, the sleeve area along the tip and sidewall The fluid accumulated in 1146a or 1146b is still lost and not collected by vessel 1146a or 1146b. The sleeve 1156 may also include a narrowed region 1176 to facilitate engagement of the sleeve with a device that provides fluid communication with the channels 1126 and 1128, such as, but not limited to, a needle, probe, tube, channel, or other adapter channel 1150.

In the embodiment of FIG. 11F, the openings 1158 are sized based on calculations sufficient to withstand the fluid pressure associated with capillary flow from the channels in the sample-filled portion 1120. This force allows opening 1158 to expel air from the channel where it is located, and also prevents fluid from exiting the sleeve until vessels 1146a and 1146b are pushed to engage adapter channels 1150 and 1152. Due to the vent created by opening 1158, the sleeve sidewalls and other areas can be made to engage the needle much more tightly than in conventional sleeves. This reduces the clearance space between the needle and the sleeve and therefore minimizes the amount of fluid that may be lost compared to a sleeve without a vent hole which has a much larger clearance space due to the looseness of the fit. In addition, the opening 1158 can also be sized so that once the fluid reaches the opening, the opening provides sufficient resistance to also stop outflow from the channel or needle, so that in any gap between the sleeve and needle tip here fluid loss is minimal.

The calculation used to set the opening size is shown in Figure 12. It is desirable to balance the forces so that there is sufficient leak-proof force associated with the hydrophobic material defining the vent hole to contain the outflow of the sample fluid outside the cartridge. In Figure 12, the sidewall of the sleeve 1156 may be in direct contact with the needle, or in some embodiments, there may be a gap along the sidewall of the sleeve. In one embodiment, the sleeve 1156 comprises a hydrophobic material such as, but not limited to, thermoplastic elastomer (TPE), butyl rubber, silicone, or other hydrophobic material. In one embodiment, the thickness of the sleeve will also determine the length of the sidewall of the opening in sleeve 1156 or vent hole 1158.

Openings 1158 may be located at one or more locations along sleeve 1156 . Some embodiments may have openings as shown in FIG. 12 . Alternatively, some embodiments may have openings 1158 in the side walls of the sleeve. Other locations are not excluded. Optionally, the sleeve 1156 may have openings that extend through the sleeve but are configured such that fluid does not exit the sleeve and the resistance from the openings is sufficient to prevent additional outflow from the channel until the vessel 1146a or 1146b engages and is in fluid communication with the channel.

Regarding how the device 1100 is used to collect a sample, in one technique, the sample collection device 1100 is kept engaged with the target body fluid and held in place until a desired fill level is reached. During this time, the device 1100 may be held horizontally to minimize the gravitational forces that would need to be overcome if the device 1100 were held more vertically. After the fill level is reached, the device 1100 can be disengaged from the target fluid, and then the vessels 1146a and 1146b can be engaged to draw the collected fluid into the vessels. Optionally, the device 1100 can be left in contact with the target fluid and the vessel engaged in fluid contact with the channel so that the fill will draw fluid in the channel and possibly any additional sample fluid remaining at the target site. This ensures that adequate body fluids are drawn into the vessel.

After the vessels 1146a and 1146b are filled, the container can be prepared for shipping. Optionally, they can be sent for pre-processing prior to shipping. Some embodiments of vessels 1146a and 1146b include a density of material in the vessel such that after pretreatment, such as centrifugation, the material, due to its selected density, will cause a portion of the centrifuged sample to be identical to the Another portion of the centrifuged sample in the vessel separates.

The container 1146a or 1146b may have a vacuum and/or negative pressure therein. When the channel is brought into fluid communication with the vacuum vessel, the sample can be drawn into the vessel. Alternatively, the vessel may take the form of a test tube-like device having the properties of those sold under the trademark "Vacutainer" by the Becton-Dickinson Company of East Rutherford, NJ. While the sample is being transferred into the vessel, the device can remain in a compressed state with the base 1140 closing the gap 1154. The sample can fill the entire vessel or a portion of the vessel. The entire sample from the channel (and/or 90%, 95%, 97%, 98%, 99%, 99.5% or more of the sample) can be transferred to the vessel. Alternatively, only a portion of the sample from the channel can be transferred to the vessel.

In one embodiment as described herein, the two-stage filling of the sample fluid into the sample collection device 1100 allows: i) a metered collection of the sample fluid to ensure that a sufficient amount is obtained in the collection channel treated to prevent premature coagulation , and in turn ii) an efficient way to transfer a high percentage of sample fluid into the vessel. This low-loss filling of the vessel from the pre-filled channel to meter the smallest amount of sample fluid into the vessel 1146 provides a number of advantages, especially when dealing with collecting small volumes of sample fluid. Prefilling the channel to the desired level ensures that sufficient volume is present in the vessel for the desired detection of the sample fluid.

As described herein, the entire device, including sample filling portion 1120, holder 1130, and base 1140, is fully transparent or translucent to allow visualization of the components therein. Optionally, only one of the sample filling portion 1120, the holder 1130 and the base 1140 is fully transparent or translucent. Optionally, only selected portions of the sample filling portion 1120, holder 1130, or base 1140 are transparent or translucent. The user can then more accurately determine when to perform various procedures based on the progress of the sample fluid fill and the engagement of the sample vessel to the channels in the sample fill portion 1120. Air bubbles in the collection channel can be visible during filling, and if bubbles are seen, the user can adjust the position of the sample collection device 1100 to better engage the target sample fluid, thereby minimizing air ingestion into the channel. It will also allow the user to know when to disengage or disengage parts such as the base or vessel holder 1140 when filling is complete.

It will be appreciated that other methods may be used to prevent sample flow outward from adapter channels 1150 and 1152 if the device is held at a non-horizontal angle, such as, but not limited to, downward in a vertical manner. In one embodiment, frit 1194 may be used with a needle having a central hole that serves as adapter channels 1150 and 1152. The frit can be located within the body of the sample collection device or on the collection container. In some embodiments, the frit comprises a material such as, but not limited to, PTFE. Alternatively, some embodiments may use tape/adhesive on the needles that function as adapter channels 1150 and 1152. In one embodiment, tape and/or adhesive may be used to cover the needle opening to prevent premature expulsion of the sample. Optionally, some embodiments may have adapter channels 1150 and 1152 with hydrophobic surfaces to prevent controlled outflow from the adapter channel openings leading to the sample vessel. In some embodiments, adapter channels 1150 and 1152 are needles with hydrophobic material only on the inner surface near the outlet. Optionally, the hydrophobic material is only on the outer surface of the needle near the outlet. Optionally, the hydrophobic material is located on the inner and outer surfaces of the needle. Alternatively, another method of preventing downward flow is to increase the surface area of the capillary by changing the cross-section. By way of non-limiting example, some embodiments may introduce teeth or fingers within the capillary in order to increase the surface area in the cross-section of the capillary. Optionally, some embodiments may include fins within the capillary towards and/or away from fluid flow in order to increase the surface area in the cross-section of the capillary. Variations and substitutions are possible for the embodiments described herein, and no single embodiment should be construed as encompassing the entire invention.

One sample collector location to multiple channels

Referring to Figures 13A-13B, yet another embodiment as described herein will now be described. 13A shows a top view of a sample filling portion 1320 having a single collection location 1322, such as but not limited to where two channels 1324 and 1326 meet to draw fluid away from the single sample collection location 1322 Collection holes. Alternatively, some embodiments may use a Y-shaped split channel configuration in which only a single channel leads away from collection location 1322 and then splits into channels 1324 and 1326 after having become a single common channel leading away from collection location 1322 . A member providing fluid communication to channels 1324 and 1326, such as, but not limited to, needles, probes, tubes, channels, hollow elongate members or other structures, etc., may be coupled to one end of sample filling portion 1320.

Figure 13B shows a side cross-sectional view showing collection location 1322 and in fluid communication with passage 1326, which in turn is in fluid communication with adapter passage 1352, such as, but not limited to, a fluid communication member. In some embodiments, the fluid communication member may have a sufficiently rigid and sufficiently penetrating tip to pierce a septum, cap, or other structure of the vessel. Some embodiments may have adapter channels 1352, 1150, etc. non-coring structures so as not to leave holes in the septum, cap or other structures of the vessel that will not seal.

As seen in Figure 13B, as indicated by droplet D, sample fluid may be applied or dropped into collection location 1322. Alternatively, some embodiments may directly apply or directly contact the collection location 1322 to apply the sample fluid. Although embodiments herein are shown using only a single collection location 1322, it should be understood that other embodiments are also contemplated in which multiple channels are coupled to a common sample collection point. By way of non-limiting example, one embodiment of a collection device may have two collection locations 1322, each with its own set of channels leading away from its respective collection location. Some embodiments may combine the common collection point channel shown in Figures 13A-13B with separate channels such as those shown in Figures 11A-11F. Other combinations of common collection location structures with other structures with separate channels are not excluded.

13B also shows that this embodiment may include one or more tissue penetrating members 1327 configured to extend outwardly from the collection location 1322. In one embodiment, this enables the user to place the target tissue at both the collection site 1322 and the wound creation site for fluid sample collection. Optionally, trigger 1323 can be positioned to fire the tissue penetrating member. Optionally, a trigger is built into the tissue interface of the device to support firing of the device upon contact with target tissue and/or when sufficient pressure or contact is in place. This overlap of the two positions allows the user to follow a simplified protocol for successful sample collection. One or more tissue penetrating members 1327 may be actuated by one or more actuation techniques such as, but not limited to, spring actuation, spring/cam actuation, electronic actuation, or any one or more of the foregoing. a combination. It should be understood that other auxiliary methods, such as, but not limited to, vacuum sources, tissue stretching devices, tissue engaging nozzles, etc., may also be used alone or in combination with any of the foregoing methods to improve sample collection.

Referring to Figure 13C, a further embodiment of the sample collection device will now be described. This embodiment shows a cartridge 1400 having a sample collection device 1402 integrated therein. There is a collection location 1322 and one or more sample openings 1325 and 1329, where sample collection can then be accessed at location 1322, such as but not limited to processing by a pipette tip (not shown). The sample from droplet D will travel, as indicated by the arrows, along passage 1326 towards openings 1325 and 1329, wherein any sample located in the openings and in passages 1324 and/or 1326 leading to their respective openings 1325 and 1329 is aspirated into pipette P. As indicated by the arrow near the pipette P, the pipette P is movable in at least one axis to support the delivery of the sample fluid to one or more desired locations. In this embodiment, the cartridge 1400 may have a plurality of holding vessels 1410 for reagents, flushing fluids, mixing areas, incubation areas, and the like. Optionally, some embodiments of the cartridge 1400 may not include any containment vessels, or alternatively, only one or two types of containment vessels. Alternatively, in some embodiments, the holding vessel may be a pipette tip. Optionally, in some embodiments, the holding vessel is a pipette tip that is treated to contain one or more reagents on the tip surface (typically the tip inner surface, but not to the exclusion of other surfaces). Alternatively, some embodiments of the cartridge 1400 may include only the sample collection device 1402 and no tissue penetrating member, or vice versa.

Referring now to Figure 13D, a side cross-sectional view of the embodiment of Figure 13C is shown. Optionally, a sample penetrating member 1327 may be included for use with the creation of a wound for sample fluid to be collected at location 1322.

14 shows that the sample filling portion 1320 can be coupled with the brackets 1330 and 1340 to form the sample collection device 1300. A visualization window 1312 may exist to see if the sample fluid has reached the desired fill level. A force application component, such as a spring 1356 or a rubber band, may be included. The channel retainer keeps the channel secured to the bracket. In one embodiment, the retainer prevents the channel from sliding relative to the stent. It may be coupled to the channel using a press fit, mechanical fastening, adhesive or other attachment techniques. The retainer may optionally be provided with a bracket upon which a force-applying component such as a spring may rest.

In one example, the engagement assembly can include a spring 1356 that can apply a force such that the base 1340 is in an extended state when the spring is in its natural state. When the base is in its extended state, space may be provided between the vessels 1346a, 1346b and the engagement assembly. In some cases, the second end of the channel may or may not contact the cap of the vessel when the base 1340 is in its extended state. The second ends of the fluid communication members 1352 can be in a position where they are not in fluid communication with the interior of the vessel.

Bringing the holder 1330 and base 1340 together will bring the channels 1324 and 1326 into fluid communication with the vessels 1346a and 1346b as the member 1352 penetrates the caps on the vessels and thereby draw sample fluid into the vessels 1346a and 1346b.

Vessel 1346a or 1346b may have vacuum and/or negative pressure therein. When the channel is brought into fluid communication with the vacuum vessel, the sample can be drawn into the vessel. The device can be held in a compressed state with the base 1340 positioned so that the vessel is in fluid communication with channels 1326 and 1328 when sample fluid is being transferred to the vessel. The sample can fill the entire vessel or a portion of the vessel. The entire sample (and/or 90%, 95%, 97%, 98%, 99%, 99.5% or more of the sample) from the channel can be transferred to the vessel. Alternatively, only a portion of the sample from the channel can be transferred to the vessel.

As seen in Figure 15, in one embodiment as described herein, the two-stage filling of sample fluid into sample collection device 1300 allows: i) metered collection of sample fluid to ensure that An efficient way to obtain a sufficient amount in the collection channel, and in turn ii) transfer a high percentage of the sample fluid into the vessel. This low-loss filling of the vessel from the pre-filled channel to meter the smallest amount of sample fluid into the vessel 1346 provides a number of advantages, especially when dealing with collecting small volumes of sample fluid. Prefilling the channel to the desired level ensures that sufficient volume is present in the vessel for the desired detection of the sample fluid.

16 and 17, further embodiments will now be described. 16 shows blood collection device 1300 with secondary collection area 1324 around collection location 1322. Secondary collection area 1324 may be used to direct any spilled, spilled or misdirected fluid sample towards collection location 1322.

Figure 17 further shows that vessels 1346a and 1346b may each have an identifier associated with vessels 1346a and 1346b. 17 shows that in one non-limiting example, the identifiers 1600 and 1602 may be at least one of: barcode (eg, 1-D, 2-D, or 3-D), quick response (QR ) codes, images, shapes, words, numbers, alphanumeric strings, colors, or any combination thereof, or any type of visual identifier. Other embodiments may use markers that are not in the visible spectrum. Other embodiments may use RFID tags, RF markers, IR light emitting tags, or other markers that do not rely on identification by signals sent over the visible spectrum.

Identifiers 1600 and 1602 may be used to identify the sample and/or sample type in the sample collection device. One or more identifiers may be present per vessel. Some embodiments may also use a marker on the vessel holder. The identifier may identify the sample collection device, one or more individual vessels within the device, or a component of the device. In some cases, the sample collection device, a portion of the sample collection device, and/or the vessel may be transported. In one example, the sample collection device, portions of the sample collection device, may be shipped via a delivery service or any other service described elsewhere herein. The sample can be delivered to perform one or more assays on the sample.

The identity of the sample and/or the identity of the individual providing the sample can be tracked. Information associated with the individual or individuals providing the sample (e.g., name, contact information, social security number, date of birth, insurance information, billing information, medical history) and other information of the sample provider can be included. In some cases, the type of sample (e.g., whole blood, plasma, urine, etc.) can be tracked. The types of reagents that the sample will encounter (eg, anticoagulants, labels, etc.) can also be tracked. Additional information regarding sample collection may be considered, such as the date and/or time of collection, the environment in which the sample was collected, the type of testing to be performed on the sample, insurance information, medical record information, or any other type of information.

Identifiers can aid in tracking such information. Identifiers can be associated with such information. Such information may be stored outside the sample collection device, within the sample collection device, or any combination thereof. In some cases, the information may be stored on one or more external devices, such as a server, computer, database, or any other device with memory. In some cases, the information may be stored on cloud computing infrastructure. One or more resources that store information can be distributed on the cloud. In some cases, peer-to-peer infrastructure can be provided. The information may be stored within the marker itself, or may be associated with the marker elsewhere, or any combination thereof.

Identifiers can provide unique identification, or can provide a high probability of providing unique identification. In some cases, the marker may have a visual component. The marker can be optically detectable. In some cases, the markers may be identifiable using visible light. In some examples, the identifiers may be barcodes (eg, 1-D, 2-D, or 3-D), quick response (QR) codes, images, shapes, words, numbers, alphanumeric strings, colors, or any combination thereof , or any type of visual identifier.

In other embodiments, the marker may be optically detectable via any other kind of radiation. For example, the marker may be detectable via infrared, ultraviolet, or any other type of wavelength of the electromagnetic spectrum. The marker may utilize luminescence, such as fluorescence, chemiluminescence, bioluminescence, or any other type of light emission. In some cases, the identifier may be a radio transmitter and/or receiver. The identifier may be a radio frequency identification (RFID) tag. The identifier can be any type of wireless transmitter and/or receiver. The marker may transmit one or more electrical signals. In some cases, GPS or other location-related signals may be used with the marker.

The markers may include audio components or acoustic components. The identifier may emit a sound, which may be recognizable, to uniquely identify the identified component.

The marker may be detectable via an optical detection device. For example, a barcode scanner may be able to read the identifier. In another example, a camera (e.g., a camera for still or video images) or other image capture device may be capable of capturing an image of the marker and analyzing the image to determine the marker.

Figures 16 and 17 illustrate examples of identifiers provided for use with sample collection device 1300, according to embodiments described herein. In one example, the sample collection device can include a base 1340, which can support and/or contain one or more vessels 1346a, 1346b. A sample can be provided to a sample collection device. A sample can be provided to a sample collection device via inlet 1322. The sample may travel to one or more vessels 1346a, 1346b within the device.

One or more markers 1600, 1602 may be provided on the sample collection device. In some embodiments, the identifier can be positioned on the base 1340 of the sample collection device. The marker can be positioned on the bottom surface of the base, the side surface of the base, or any other portion of the base. In one example, the base may have a flat bottom surface. The logo may be located on the flat bottom surface of the base. One or more recesses may be provided in the base. An identifier can be located within the recess. The recesses may be located on the bottom surface or the side surfaces of the base. In some embodiments, the base may include one or more protrusions. A marker can be located on the protrusion. In some cases, markers may be provided on the outer surface of the base. The marker may alternatively be positioned on the inner surface of the base. The marker can be detected from outside the sample collection device.

In some embodiments, markers may be provided on vessels 1346a, 1346b. The marker may be located on the outer surface of the vessel or on the inner surface of the vessel. The identifier may be detectable from outside the vessel. In some embodiments, a marker may be provided on the bottom surface of the vessel.

In one example, the base may include a light transmissive portion. The light-transmitting portion may be located on the bottom of the base or on the side of the base. For example, transparent or translucent windows can be provided. In another example, the light transmissive portion may be a windowless hole. The light transmissive portion may allow portions within the base to be visible. The marker may be provided on the outer surface of the base on the light transmissive portion, provided on the inner surface of the base but visible through the light transmissive portion, or provided on the outer or inner surface of the vessel but visible through the light transmissive portion partially visible. In some cases, the marker can be provided on the inner surface of the vessel, but the vessel can be light transmissive so that the marker can be viewed through the vessel and/or the light transmissive portion.

The identifier may be a QR code or other optical identifier that is optically visible from the outside of the sample collection device. The QR code can be visible through an optical window or hole in the bottom of the base of the sample collection device. The QR code can be provided on the base of the sample collection device or on a portion of the vessel that is visible through the base. Image capture devices such as cameras or scanners can be provided outside the sample collection device and can be capable of reading QR codes.

Single or multiple QR codes or other identifiers can be provided on the sample collection device. In some cases, each vessel may have at least one identifier, such as a QR code associated therewith. In one example, at least one window may be provided in the base for each vessel, and each window may allow a user to view a QR code or other identifier. For example, two vessels 1346a, 1346b can be housed within the base 1340, with each vessel having an associated identifier 1600, 1602 identifiable from outside the sample collection device.

Base 1340 may be detachable from holder 1330 or other parts of the sample collection device. The one or more identifiers may be detachable from the remainder of the sample collection device along with the base.

In some embodiments, the identifier may be provided with the vessel received by the base. Separating the base from the rest of the sample collection device can cause the vessel to separate from the rest of the sample collection device. The vessel can remain in the base or can be removed from the base. The marker can remain with the vessel even if the vessel is removed from the base. Alternatively, the marker may remain with the base even if the vessel is removed. In some cases, both the base and the vessel can have identifiers so that the vessel and base can be individually tracked and/or matched even when separated.

In some cases, any number of vessels may be provided within the sample collection device. The sample vessel may be capable of receiving a sample from the subject. Each sample vessel can have a unique identifier. A unique identifier can be associated with any information related to a sample, subject, device, or component of a device.

In some cases, each identifier for each vessel may be unique. In other embodiments, the identifier on the vessel need not be unique, but may be unique to the device, to the subject, or to the sample type.

A sample collection device can receive a sample from a subject. The subject may directly contact the sample collection device or provide a sample to the device. The sample may travel through the device to one or more vessels within the device. In some cases, the sample can be processed before it reaches the vessel. One or more coatings or substances can be provided within the sample collection unit and/or channel that can deliver the sample to the vessel. Alternatively, the sample is not provided for processing until it reaches the vessel. In some embodiments, the sample may or may not be processed within the vessel. In some cases, multiple different types of treatments may be provided to the sample before or while the sample reaches the vessel. Processing can be provided in a preselected order. For example, a first process is desired first, and it can be provided upstream of a second process. In some cases, samples were not processed at any point.

In some embodiments, the sample can be a blood sample. The first vessel can receive whole blood and the second vessel can receive plasma. The anticoagulant can be provided along the fluid path and/or in the vessel.

Once the vessel has been provided with a sample and the vessel has been sealed, the vessel can be sent to a separate location for sample analysis. The separate location may be a laboratory. The separate location may be a remote facility relative to the sample collection site. The entire sample collection device can be sent to a single location. One or more identifiers can be provided on the sample collection device and can be used to identify the sample collection device and/or vessels therein. Alternatively, the base 1340 can be removed from the sample collection device and sent to a separate location with the vessel therein. One or more identifiers can be provided on the base and can be used to identify the base and/or the vessel therein. In some cases, the vessel can be removed from the base and sent to a separate location. One or more markers can be provided on each vessel and can be used to identify the vessel.

The identifier can be read by any suitable technique. By way of example and not limitation, in some cases, an optical detector, such as an image capture device or barcode scanner, is used to read the identifier. In one example, the image capture device can capture an image of the QR code. Information about the vessel can be tracked. For example, when a vessel arrives at a location, the marker can be scanned and a record of the vessel's arrival can be kept. The progress and/or position of the vessel can be updated actively and/or passively. In some cases, it may be necessary to intentionally scan the marker in order to determine the location of the vessel. In other examples, the marker can actively emit a signal that can be picked up by a signal reader. For example, a signal reader can track the location of the marker as it passes through the building.

In some cases, reading the marker may allow the user to obtain additional information associated with the marker. For example, a user may use some kind of device to capture an image of the marker. The device or another device may display information about the sample, subject, device, components of the device, or any other information described elsewhere herein. Information about the test to be performed and/or the test results may be included. The user can perform subsequent tests or actions on the sample based on the information associated with the identifier. For example, the user can guide the vessel into place for inspection. In some cases, the vessel can be guided into place and/or the contents of the vessel can be subjected to appropriate sample processing (e.g., sample preparation, assay, detection, analysis) in an automated manner without human intervention.

Information about sample processing can be collected and associated with the markers. For example, if the vessel has an identifier, and sample processing has been performed on the contents of the vessel, one or more signals generated in response to the sample processing can be stored and/or associated with the identifier. Such updates can be performed in an automated manner without human intervention. Alternatively, the user may initiate the storage of the information, or the information may be entered manually. Thus, medical records about a subject can be aggregated in an automated manner. Identifiers can be used to index and/or access information about the subject.

sample vessel

18A-18B illustrate a non-limiting example of a sample vessel 1800 that can be used with a sample collection device, according to embodiments described herein. In some cases, the sample vessel may be supported by the sample collection device. Alternatively, the sample vessel may be contained or enclosed by a portion of the sample collection device. In one example, the sample collection device may have a first configuration in which the sample vessel is fully enclosed. A second configuration can be provided in which the sample collection device can be open and at least a portion of the sample vessel can be exposed. In some examples, the sample vessel may be supported and/or at least partially enclosed by the holder of the sample collection device. The holder may be separable from the rest of the sample collection device to provide access to the sample vessel therein.

In the case of bodily fluid sample collection, methods such as, but not limited to, US Patent Application Serial No. 61/697,797, filed September 6, 2012, and US Patent Application Serial No. 61/798,873, filed March 15, 2013, may be used. The described sample collection device, which draws a sample fluid from a patient, is hereby incorporated by reference in its entirety for all purposes. In a non-limiting example of a blood sample, some embodiments may collect a blood sample by collecting capillary blood from a subject. This can occur by means of a wound, penetration site, or other entry site to capillary blood from the subject. Alternatively, blood can also be collected by venipuncture or other vascular puncture to obtain a blood sample for loading into one or more sample vessels. For example, blood may be collected by a device configured for small volume blood collection by venipuncture. Such a device may, for example, comprise a hollow needle fluidly connected or capable of being fluidly connected to a vessel having a smaller internal volume. Said vessel with smaller internal volume may have, for example, equal to or not more than 5ml, 4ml, 3ml, 2ml, 1ml, 750l, 500l, 400l, 300l, 200l, 100l, 90l, 80l, 70l, 60l, 50l, 40l, Internal volume of 30l, 20l, 10l or 5l. Other types of devices and techniques for collecting bodily fluids are not excluded.

Bodily fluids can be drawn from a subject and provided to the device by a variety of means including, but not limited to: finger stick, incision, injection, aspiration, wiping, pipetting, phlebotomy, venipuncture and/or any other techniques described elsewhere herein. In some embodiments, the sample can be collected from the subject's breath. Bodily fluids can be provided using a bodily fluid collector. Bodily fluid collectors can include lancets, capillaries, tubes, pipettes, syringes, needles, microneedles, pumps, or any other collector described elsewhere herein. In some embodiments, the sample can be a tissue sample that can be provided from a subject. The sample may be removed from the subject or may have been discarded by the subject.

In one embodiment, the lancet pierces the skin of the subject and draws the sample, for example, using gravity, capillary action, suction, differential pressure, or vacuum force. The lancet or any other bodily fluid collector may be part of the device, part of the cartridge of the device, part of the system, or a separate component. When desired, the lancet or any other bodily fluid collector may be activated by a variety of mechanical, electrical, electromechanical or any other known activation mechanisms or any combination of such methods.

In one example, the subject's finger (or other part of the subject's body) can be punctured to obtain bodily fluids. Bodily fluids can be collected using capillaries, pipettes, swabs, drops, or any other mechanism known in the art. The capillary or pipette may be separate from the device and/or the cartridge of the device, or may be part of the device and/or the cartridge that can be inserted into or attached to the device. In another embodiment that does not require an enabling mechanism, the subject may simply provide the device and/or the cartridge with the bodily fluid, e.g., with a saliva sample to provide the bodily fluid.

Bodily fluids can be drawn from the subject and provided to the device in a variety of ways including, but not limited to, finger sticks, incisions, injections, and/or pipetting. Body fluids can be collected using intravenous or non-intravenous methods. Body fluids can be provided using a body fluid collector. Bodily fluid collectors may include lancets, capillaries, tubes, pipettes, syringes, phlebotomies, or any other collector described elsewhere herein. In one embodiment, the lancet pierces the skin and draws the sample, for example, using gravity, capillary action, suction, or vacuum force. The lancet may be part of the device, part of the cartridge of the device, part of the system, or a separate component. When desired, the lancet can be activated by a variety of mechanical, electrical, electromechanical or any other known activation mechanisms or any combination of such methods. In one example, the subject's finger (or other part of the subject's body) can be punctured to obtain bodily fluids. Examples of other parts of the subject's body may include, but are not limited to, the subject's hands, wrists, arms, torso, legs, feet, or neck. Bodily fluids can be collected using capillaries, pipettes, or any other mechanism known in the art. The capillary or pipette may be separate from the device and/or cartridge, or may be part of the device and/or cartridge. In another embodiment that does not require an enabling mechanism, the subject may simply provide the device and/or the cartridge with a bodily fluid, for example, with a saliva sample. The collected bodily fluid can be placed in the device. The bodily fluid collector may be attached to the device, removably attached to the device, or may be provided separately from the device.

A sample obtained from a subject can be stored in sample vessel 1800. In one embodiment described herein, the sample vessel 1800 includes a body 1810 and a cap 1820. In some cases, at least portions of the sample vessel body may be formed from a transparent or translucent material. The sample vessel body may allow a sample provided within the sample vessel body to be visible when viewed from outside the sample vessel. The sample vessel body may be light transmissive. The sample vessel body may be formed from a material that can allow electromagnetic radiation to pass therethrough. In some cases, the sample vessel body may be formed of a material that allows the passage of electromagnetic radiation of selected wavelengths and does not allow the passage of electromagnetic radiation of other non-selected wavelengths. In some cases, a portion or the entire body may be formed from a material that is opaque along selected wavelengths of electromagnetic radiation, such as wavelengths of visible light. Optionally, portions of the sample vessel body can be shaped to provide a certain optical path length. Optionally, portions of the sample vessel body may be shaped to provide flat surfaces (outer and/or inner surfaces) or other structures to allow analysis of the sample while it is in the sample vessel.

In one embodiment, an open end and a closed end may be provided on the sample vessel body 1810. The open end can be the top end 1812 of the sample vessel 1800, which can be at the end that can be configured for engagement with the cap. The closed end may be the bottom end 1814 of the sample vessel, which may be at the end of the sample vessel opposite the cap. In alternative embodiments, the bottom end may also be an open end that can be closed using a bottom plate. In some embodiments, the cross-sectional area and/or shape of the top and bottom ends may be substantially the same. Alternatively, the cross-sectional area of the top end may be greater than the cross-sectional area of the bottom end, or vice versa. Variations and substitutions are possible for the embodiments described herein, and no single embodiment should be construed as encompassing the entire invention.

In one embodiment, the sample vessel body may have an inner surface and an outer surface. The surface of the sample vessel body may be smooth, rough, textured, faceted, shiny, dull, contain grooves, contain ridges, or have any other feature. The surface of the sample vessel body can be treated to provide desired optical properties. The inner and outer surfaces may have the same properties or may be different. For example, the outer surface may be smooth and the inner surface rough.

Alternatively, the sample vessel body may have a tubular shape. In some cases, the sample vessel body may have a cylindrical portion. In some cases, the sample vessel may have a circular cross-sectional shape. Alternatively, the sample vessel may have any other cross-sectional shape, which may include oval, triangular, quadrilateral (eg, square, rectangle, trapezoid, parallelogram), pentagon, hexagon, heptagon, octagon shape or any other shape. The cross-sectional shape of the sample vessel may or may not have a convex and/or concave shape. The cross-sectional shape of the sample vessel may remain the same along the length of the sample vessel, or may vary. The sample vessel may have a prismatic shape along the length of the body. Prisms can have cross-sectional shapes as described herein.

Optionally, the bottom 1814 of the sample vessel can be flat, tapered, rounded, or any combination thereof. In some cases, the sample vessel may have a hemispherical bottom. In other embodiments, the sample vessel may have a rounded bottom with a flat portion. The sample vessel may or may not be able to stand on its own flat surface.

In one embodiment, the sample vessel 1800 can be sized to contain small fluid samples. In some embodiments, the sample vessel can be configured to contain no more than about 5ml, 4ml, 3ml, 2ml, 1.5mL, 1mL, 900uL, 800uL, 700uL, 600uL, 500uL, 400uL, 300uL, 250uL, 200uL, 150uL , 100uL, 80uL, 50uL, 30uL, 25uL, 20uL, 10uL, 7uL, 5uL, 3uL, 2uL, 1uL, 750nL, 500nL, 250nL, 200nL, 150nL, 100nL, 50nL, 10nL, 5nL, 1nL, 500pL, 300pL , 50pL, 10pL, 5pL or 1pL. By way of non-limiting example, the sample vessel may have an information storage unit thereon, such as discussed with respect to Figures 18F and 18G. In one non-limiting example, the sample vessel 100 can hold small volumes of sample fluid in liquid form without the use of wicking materials, sieves, solid matrices, etc. to hold the sample fluid during transport. This allows the sample fluid to be removed from the sample vessel substantially in liquid form without loss of sample or sample integrity due to absorption of the liquid by the wicking material or other material.

Alternatively, the sample vessel 1800 may be configured to contain no more than several drops of blood, a drop of blood, or a portion of no more than a drop of blood. For example, the sample vessel may have an interior volume no greater than the amount of fluid sample it is configured to contain. Having a small volume of sample vessels can advantageously allow storage and/or transportation of a large number of sample vessels in a small volume. This can reduce resources for storing and/or transporting sample vessels. For example, less storage space may be required. Additionally, sample vessels can be transported using less cost and/or fuel. For the same amount of effort, a greater number of sample vessels can be transported.

In some embodiments, the sample vessel 1800 may have a small length. For example, the sample vessel length can be no greater than 8cm, 7cm, 6cm, 5cm, 4cm, 3.5cm, 3cm, 2.5cm, 2cm, 1.7cm, 1.5cm, 1.3cm, 1.1cm, 1cm, 0.9cm, 0.8cm, 0.7cm , 0.6cm, 0.5cm, 0.4cm, 0.3cm, 0.2cm, 0.1cm, 700um, 500m, 300um, 100um, 70um, 50um, 30um, 10um, 7um, 5um, 30um or 1um. In some cases, the largest dimension (eg, length, width, or diameter) of the sample vessel may be no greater than 8 cm, 7 cm, 6 cm, 5 cm, 4 cm, 3.5 cm, 3 cm, 2.5 cm, 2 cm, 1.7 cm, 1.5 cm, 1.3 cm , 1.1cm, 1cm, 0.9cm, 0.8cm, 0.7cm, 0.6cm, 0.5cm, 0.4cm, 0.3cm, 0.2cm, 0.1cm, 700um, 500m, 300um, 100um, 70um, 50um, 30um, 10um, 7um , 5um, 30um or 1um.

The sample vessel 1800 can have any cross-sectional area. The cross-sectional area may be no greater than about 16 cm ² , 8 cm ² , 7 cm ² , 6 cm ² , 5 cm ² , 4 cm ² , 3.5 cm ² , 3 cm ² , 2.5 cm ² , 2 cm ² , 1.5 cm ² , 1 cm ² , 0.9 cm ² , 0.8cm ² , 0.7cm ² , 0.6cm ² , 0.5cm ² , 0.4cm ² , 0.3cm ² , 0.2cm ² , 0.1cm ² , 0.07cm ² , 0.05cm ² , 0.03cm ² , 0.02cm ² , 0.01cm ² , 0.5cm ² , 0.3cm ² or 0.1cm ² . The cross-sectional area may remain the same or may vary along the length of the sample vessel.

The sample vessel 1800 can have any thickness. The thickness may remain the same along the length of the sample vessel or may vary. In some cases, the thickness can be selected and/or can be varied to provide desired optical properties. In some cases, the thickness may be no greater than 5mm, 3mm, 2mm, 1mm, 700um, 500um, 300um, 200um, 150um, 100um, 70um, 50um, 30um, 10um, 7um, 5um, 3um, 1um, 700nm, 500nm, 300nm or 100nm.

In one embodiment, the sample vessel 1800 may have a shape that facilitates supporting centrifugation of small volume blood samples. This allows the collected sample in the sample vessel to be taken directly to the centrifuge without having to further transfer the sample fluid to yet another sample vessel used in the centrifuge device.

Optionally, the sample vessel may include a cap 1820. Cap 1820 can be configured to fit over the open end of the sample vessel. The cap can block the open end of the sample vessel. Caps can fluidly seal sample vessels. The cap may form a fluid-tight seal with the sample vessel body. For example, the cap may be gas and/or liquid impermeable. Alternatively, the cap may allow certain gases and/or liquids to pass through. In some cases, the cap may be breathable and liquid-impermeable. The cap can be impermeable to the sample. For example, the cap may be impermeable to whole blood, serum or plasma.

Optionally, the cap may be configured to engage the sample vessel body in any manner. For example, the cap may be press fit with the sample vessel body. A friction fit and/or an interference fit may allow the cap to rest on the body. In other examples, locking mechanisms may be provided, such as slide mechanisms, clamps, fasteners, or other techniques. In some cases, the cap and/or sample vessel body may be threaded to allow screw-type engagement. In other examples, the cap may be attached to the sample vessel body using adhesive, welding, soldering, brazing. The cap can be removably attached to the sample vessel body. Alternatively, the cap can be permanently affixed to the sample vessel body.

In some cases, a portion of the cap may fit into a portion of the sample vessel body. The cap may form a stopper with the sample vessel body. In some cases, a portion of the sample vessel body may fit into a portion of the cap. The plug can include a flange or shelf that can overlie a portion of the body of the sample vessel. A flange or shelf prevents the cap from sliding into the sample vessel body. In some cases, a portion of the cap may overlie the top and/or sides of the sample vessel body. Optionally, some embodiments may include additional components in the vessel assembly, such as cap holders. In one embodiment, the purpose of the cap retainer is to maintain a tight seal between the cap and the sample vessel. In one embodiment, the cap retainer engages an attachment, flange, recess, or other attachment location on the exterior of the sample vessel to hold the cap in place. Alternatively, some embodiments may combine the functionality of both cap and cap retainer into one assembly.

In some embodiments, the sample vessel body may be formed from a rigid material. For example, the sample vessel body may be formed from a polymer such as polypropylene, polystyrene, or acrylic. In alternative embodiments, the sample vessel body may be semi-rigid or flexible. The sample vessel body may be formed from a single unitary piece. Alternatively, multiple parts can be used. The plurality of parts may be formed from the same material or from different materials.

Alternatively, the sample vessel cap may be formed of an elastomeric material or any other material described elsewhere herein. In some cases, the cap may be formed of rubber, polymer, or any other material that may be flexible and/or compressible. Alternatively, the cap may be semi-rigid or rigid. The sample vessel cap may be formed of a high friction material. The sample vessel cap may be capable of a friction fit to engage the sample vessel body. When the sample vessel cap is engaged with the sample vessel body, a fluid-tight seal is formed. The interior of the sample vessel body may be fluidly isolated from the surrounding air. In some cases, at least one of the cap and/or the portion of the sample vessel body that contacts the cap may be formed of a high friction and/or compressible material.

In some embodiments, cap 1820 may be a needle and/or cannula penetrable self-sealing air-tight closure in sealing engagement in the open end of the sample vessel to maintain a vacuum and/or seal within the sample vessel atmosphere. In some embodiments, the interior of the sample vessel is only under partial vacuum rather than full vacuum. Excessive vacuum may damage formed blood components in the sample fluid. By way of non-limiting example, a partial vacuum can range from about 50% to 60% of a full vacuum. Optionally, the partial vacuum is no more than about 60% of the full vacuum. Optionally, the partial vacuum is no more than about 50% of the full vacuum. Optionally, the partial vacuum is no more than about 40% of the full vacuum. By way of non-limiting example, the partial vacuum can range from about 10% to about 90% of a full vacuum, or between about 20% and about 70% of a full vacuum, or between about 30% and 60% of a full vacuum. By way of non-limiting example, the partial vacuum ranges from about 10% to about 60% of the full vacuum, or between about 20% and about 50% of the full vacuum, or between about 30% and 50% of the full vacuum. In this manner, a reduced amount of force is applied to the bodily fluid sample to minimize problems with the integrity of the sample. Optionally, after sample transfer, the atmosphere is at ambient pressure. Optionally, after sample transfer, the atmosphere is under some partial vacuum. Optionally, only one sample vessel of the plurality of sample vessels is under partial vacuum, while other sample vessels are under higher vacuum or under full vacuum.

In some embodiments, cap 1820 may be a closure device with one end inside the sample vessel and the other end outside the sample vessel, wherein the inner end has a surface in continuous sealing contact with the sample vessel, the inner end having a surface extending from the surface toward the closed end An annular sleeve having a first notch extending through a wall of the annular sleeve and juxtaposed with the sample vessel. In one embodiment, the closure has a recessed ring formed around the first notch of the inner end, and the serrated ring engages the ridges of the tubular sample vessel.

Alternatively, the sample vessel cap may be formed from a single integral piece. Alternatively, multiple parts can be used. The plurality of parts may be formed from the same material or from different materials. The cap material may or may not be the same as the sample vessel body material. In one example, the sample vessel body may be formed from a light transmissive material and the cap is formed from an opaque material.

Optionally, cap 1820 may be removably engageable with the body. A portion of the cap may be insertable into the body. The cap may include a flange, which may be located on top of the body. The flange is not inserted into the body. In this non-limiting example, the flange prevents the cap from being fully inserted into the body. The flange may form a continuous flange around the cap. In some cases, a portion of the flange may overlap or overlie a portion of the body. A portion of the body may be insertable into a portion of the cap.

Alternatively, the portion, which may be a cap insertable into the body, may have a rounded bottom. Alternatively, the portion may be flat, tapered, curved, undulating, or have any other shape. The cap can be shaped so that it can be easily inserted into the body.

In some cases, a dimple may be provided at the top of the cap. The indentation may follow the portion of the cap that is inserted into the body. In some cases, a hollow or dimple may be provided in the cap. The well may be capable of accepting a portion of the channel that may be used to deliver the sample to the sample vessel. The dimples can assist in directing the channel to the desired portion of the cap. In one example, the channel may be positioned within the pocket prior to bringing the interior of the channel and sample vessel into fluid communication.

Alternatively, the channel and cap can be pressed together such that the channel penetrates the cap and into the interior of the sample vessel, thereby bringing the channel into fluid communication with the interior of the sample vessel. In some cases, the cap may have a slit through which the channel passes. Alternatively, the channel can puncture the uninterrupted cap material. The channel can be withdrawn from the sample vessel, thereby bringing the channel and sample vessel out of fluid communication. The cap may be capable of resealing when the channel is removed. For this example, the cap may be formed from a self-healing material. In some cases, the cap can have a slit that can be closed when the channel is removed, thereby forming a fluid-tight seal.

In some embodiments, the body may include one or more flanges or other surface features. Examples of surface features may include flanges, bumps, protrusions, grooves, ridges, threads, holes, facets, or any other surface feature. Flanges and/or other surface features can circumscribe the body. Flanges and/or other surface features may be at or near the top of the body. Flanges and/or other surface features can be located on the top half, top third, top quarter, top fifth, top sixth, top eighth of the body one or the top tenth. The surface features can be used for sample vessel support within the sample collection device. The surface features can be used to remove the sample vessel from and/or position the sample vessel within the sample collection device. The flange and/or other surface features may or may not engage the cap.

Alternatively, the cap may be of any size relative to the sample vessel body. In some cases, the cap and/or body may have similar cross-sectional areas. The cap may have the same or substantially similar cross-sectional area and/or shape as the top of the body. In some cases, the cap may have a smaller length than the body. For example, the cap may have a length that may be less than 60%, 50%, 40%, 30%, 25%, 20%, 15%, 10%, 7%, 5%, 3%, or 1% of the length of the body.

Referring now to Figures 18C-18E, further embodiments of the sample vessel 1800 may include a cap retainer 1830 that fits over the cap to secure the cap in place. By way of non-limiting example, cap retainer 1830 may also include an opening in cap retainer 1830 that allows a member such as an adapter to slide through and through cap 1820. Figure 18C shows the components in an exploded view.

18D shows a cross-sectional view showing an embodiment in which the sample vessel body 1810 has a cap 1820 covered by a cap holder 1830. As seen in Figure 18D, cap holder 1830 has locking features 1832 for securing cap holder 1830 to sample vessel body 1810 and/or cap 1820. In one embodiment, the locking features 1832 include internal ridges that will engage one or more of the ridges 1812 and 1814 on the sample vessel body 1810. 18E shows a side view of cap holder 1830 coupled to sample vessel body 1810.

In some cases, the surfaces (inner and/or outer) of the sample vessel may be coated or treated with a material. For example, the inner surface of the sample vessel can be coated with fixatives, antibodies, optical coatings, anticoagulants, sample additives and/or preservatives. These can be the same or different from any material coating in the channel. In one non-limiting example, the coating may be, but is not limited to, polytetrafluoroethylene, polyxylene, polysorbate surfactants (eg, polysorbate 20), or other materials as a treatment of the surface to reduce Surface Tension.

In embodiments, the sample vessel may contain a blood clotting activator (e.g., thrombin, silica particles, glass particles), an anti-glycolytic agent (e.g., sodium fluoride), or a gel to facilitate separation of blood cells from plasma. In an example, the sample vessel may contain sodium polyanethole sulfonate (SPS), acid citrate glucose additive, perchloric acid, or sodium citrate. Some embodiments may include at least one material from each of the above groupings. Optionally, it should also be understood that other additives or materials are not excluded, especially if the additives do not interfere with each other in function.

Optionally, the coating is applied to all inner surfaces of the sample vessel. Alternatively, some embodiments may apply the coating in a pattern that covers only selected areas in the sample vessel. Some embodiments may cover only the upper interior area of the sample vessel. Alternatively, some embodiments may cover only the lower interior area of the sample vessel. Optionally, some embodiments may cover strips, lines or other geometric patterns of the interior region of the sample vessel. Optionally, some embodiments may also coat the surface of the cap, plug, or cover for use with the sample vessel. Some embodiments may coat the surface from which the sample enters the sample vessel to provide smooth transfer of the sample away from the entry area and towards a destination point such as, but not limited to, the bottom portion of the vessel.

Alternatively, the coating may be a wet coating or a dry coating. Some embodiments may have at least one dry coating and at least one wet coating. In some cases, one or more reagents can be coated and dried on the inner surface of the sample vessel. The coating may alternatively be provided in a humid environment or may be a gel. Some embodiments may include a separation gel in the sample vessel to keep selected portions of the sample away from other portions of the sample. Some embodiments may include serum separation gels and plasma separation gels, such as, but not limited to, polyester-based separation gels available from Becton Dickinson.

Optionally, one or more solid matrices may be provided within the sample vessel. For example, one or more beads or particles can be provided within the sample vessel. The beads and/or particles can be coated with reagents or any other substance described herein. The beads and/or particles may be able to dissolve in the presence of the sample. Beads and/or particles may be formed from one or more reagents, or may assist in processing the sample. The reagents can be provided in the sample vessel in gaseous form. The sample vessel may be hermetically sealed. The sample vessel may remain sealed before the sample is introduced into the sample vessel, after the sample has been introduced into the sample vessel, and/or while the sample is introduced into the sample vessel. In one embodiment, the sample vessel may have a smooth surface and/or a rounded bottom. This helps to minimize stress on the blood sample, especially during centrifugation. Of course, in alternative embodiments, other shapes of the bottom of the sample vessel are not excluded.

In embodiments, the bodily fluid sample in the sealed sample vessel may retain dissolved gases in the bodily fluid sample such that the sample stored in the sealed sample vessel remains the same as a freshly drawn bodily fluid sample from the subject's body or fresh from a different sample Prepared samples (eg, freshly prepared plasma from whole blood) are of similar or identical dissolved gas composition. In embodiments, over a period of 10 minutes, 20 minutes, 30 minutes, 45 minutes, 1 hour, 2 hours, 4 hours, 6 hours, 8 hours, 12 hours, 16 hours, 24 hours, 48 hours, or 72 hours , the body fluid sample in the sealed sample vessel can retain at least 99%, 98%, 95%, 90%, 80%, 70%, 60%, 50%, 40%, 30% or 20% of dissolved gas. Typically, in such embodiments, the period of time begins when the sample is placed in the sample vessel or when the sample vessel is sealed. To facilitate retention of dissolved gases in body fluid samples, samples can be stored in a sealed container at a selected temperature such as 20°C, 15°C, 10°C, 4°C, etc., or at freezing temperatures below 0°C in the sample vessel. Other temperatures for sample storage are not excluded.

Similarly, in embodiments, the bodily fluid sample in the sealed sample vessel can retain analytes in the bodily fluid sample such that the sample stored in the sealed sample vessel remains the same as a freshly drawn or freshly prepared bodily fluid sample from the subject's body. A bodily fluid sample (eg, freshly prepared plasma from whole blood) has a similar or identical analyte composition. In embodiments, the sample is sealed for a period of 10 minutes, 20 minutes, 30 minutes, 45 minutes, 1 hour, 2 hours, 4 hours, 6 hours, 8 hours, 12 hours, 16 hours, 24 hours, or 48 hours The body fluid sample in the vessel may retain at least 99%, 98%, 95%, 90%, 80%, 70%, 60%, 50%, 40%, 30% or 20% of the analyte. Typically, in such embodiments, the period of time begins when the sample is deposited into the sample vessel or when the sample vessel is sealed. In order to promote retention of one or more analytes in the body fluid sample, at selected temperatures such as 20°C, 15°C, 10°C, 4°C, or at freezing temperatures below 0°C, Store samples in sealed sample vessels. Other temperatures for sample storage are not excluded. Optionally, the sample vessel can be centrifuged after the sample is introduced into the vessel. For example, 30 seconds, 1 minute, 2 minutes, 3 minutes, 4 minutes, 5 minutes, 10 minutes, 15 minutes, 20 minutes, 30 minutes, 45 minutes, 1 hour, 2 hours, 4 minutes of sample introduction into the vessel Sample vessels were centrifuged within 1 hour, 8 hours, 24 hours, 2 days, 3 days, 4 days, 5 days, 7 days, or 10 days. For example, in the case of a whole blood sample, centrifugation of the sample vessel containing the sample can facilitate the separation of blood cells from plasma to obtain plasma and pelleted cells. In some cases, centrifuging the sample increases the stability of one or more analytes in blood or plasma.

Figure 18F further shows that the sample vessels may each have at least one information storage unit associated with the sample vessel. Optionally, some embodiments may enable one information storage unit to transmit information about multiple sample vessels, particularly (but not limited to) where the sample vessels all contain samples from the same subject. Such an information storage unit may be located on a carrier holding a plurality of sample vessels, rather than on the sample vessels themselves.

Figure 18F shows a bottom view of the bottom surface of one of the sample vessels, in one non-limiting example, the information storage unit 1860 may be at least one of the following: a barcode (eg, 1-D, 2 -D or 3-D), Quick Response (QR) codes, images, shapes, words, numbers, alphanumeric strings, colors, or any combination thereof, or any type of visual information storage unit. Other embodiments may use information storage cells that are not in the visible spectrum. Other embodiments may use RFID tags, RF information storage units, IR light emitting tags, or other markers that do not rely on identification through signals sent over the visible spectrum. Of course, the information storage unit 1860 may also be positioned on the top surface of the sample vessel. Figure 18G shows that, optionally, an information storage unit 1860 may also be included on the side surface of the sample vessel. This may be in addition to or in place of one or more information storage units 1860 positioned at the top or bottom.

In one non-limiting example, the information storage unit 1860 may be used to identify the sample and/or sample type in the sample collection device. Optionally, there may be one or more information storage units per sample vessel. Some embodiments may also use an information storage unit on the sample vessel holder. A sample storage unit may identify a sample collection device, one or more individual sample vessels within a device, or a component of a device. In some cases, the sample collection device, a portion of the sample collection device, and/or the sample vessel may be transported. In one example, the sample collection device or portion of the sample collection device may be shipped via a delivery service or any other service described elsewhere herein. The sample vessel can be delivered so that one or more assays can be performed on the sample.

Optionally, the identity of the sample and/or the identity of the individual providing the sample can be tracked. By way of non-limiting example, information associated with one or more individuals providing the sample (eg, name, contact information, social security number, date of birth, insurance information, billing information, medical history) and the sample provider may be included other information. In some cases, the type of sample (e.g., whole blood, plasma, urine, etc.) can be tracked. Optionally, the type of reagents (e.g., anticoagulants, markers, etc.) that the sample will encounter can also be tracked. Additional information about sample collection may be considered, such as the date and/or time of collection, the environment in which the sample was collected, the type of testing to be performed on the sample, one or more settings for testing, testing protocols, insurance information, medical Log information or any other type of information.

In at least one or more embodiments described herein, an information storage unit may assist in tracking such information. An information storage unit may be associated with such information. Such information may be stored outside the sample collection device, within the sample collection device, or any combination thereof. In some cases, the information may be stored on one or more external devices, such as a server, computer, database, or any other device with memory. In some cases, the information may be stored on cloud computing infrastructure. The one or more resources storing information may be distributed on the cloud, from a remote server over the Internet, wirelessly connected to a remote computer processor, and the like. In some cases, peer-to-peer infrastructure can be provided. The information may be stored in the information storage unit itself, or may be associated with the information storage unit elsewhere, or any combination thereof.

Optionally, the information storage unit may provide a unique identification, or may provide a high probability of providing a unique identification. In some cases, the information storage unit may have a displayable component. The information storage unit may be optically detectable. In some cases, the information storage unit may be identifiable using visible light. In some examples, the information storage unit may be a barcode (eg, 1-D, 2-D, or 3-D), quick response (QR) code, image, shape, word, number, alphanumeric string, color, or any of these composition, or any type of visual information storage unit.

In other embodiments, the information storage unit may be optically detectable via any other kind of radiation. For example, the information storage unit may be detectable via infrared, ultraviolet, or any other type of wavelength of the electromagnetic spectrum. The information storage unit may utilize luminescence, such as fluorescence, chemiluminescence, bioluminescence, or any other type of light emission. In some cases, the information storage unit may be a radio transmitter and/or receiver. The information storage unit may be a radio frequency identification (RFID) tag. The information storage unit may be any type of wireless transmitter and/or receiver. The information storage unit may transmit one or more electrical signals. In some cases, GPS or other location related signals may be used with the information storage unit.

Optionally, the information storage unit may be and/or include an audio component or an acoustic component. The information storage unit may emit a sound, which may be recognizable, to uniquely identify the identified component.

Alternatively, the information storage unit may be detectable via optical detection means. For example, a barcode scanner may be able to read the information storage unit. In another example, a camera (e.g., for still or video images) or other image capture device may be capable of capturing an image of the information storage unit and analyzing the image to determine the identity.

Alternatively, the information storage unit may be located on the holder of one or more sample vessels. One or more recesses may be provided in the retainer. Information storage cells may be located within the recesses. The recesses may be located on the bottom surface or the side surfaces of the retainer. In some embodiments, the retainer may include one or more protrusions. An information storage unit may be located on the protrusion. In some cases, the information storage unit may be provided on the outer surface of the holder. The information storage unit may alternatively be positioned on the inner surface of the holder. The information storage unit can be detected from outside the sample collection device.

In some embodiments, the information storage unit may be located on the outer surface of the sample vessel or on the inner surface of the sample vessel. The information storage unit may be detectable from outside the sample vessel. In some embodiments, an information storage unit can be provided on the bottom surface of the sample vessel.

In one non-limiting example, the holder may include a light transmissive portion. The light-transmitting portion may be located on the bottom of the holder or on the side of the holder. For example, transparent or translucent windows can be provided. In another example, the light transmissive portion may be a hole that does not require a window. The light transmissive portion may allow portions within the holder to be visible. The information storage unit may be provided on the outer surface of the holder on the light transmissive portion, provided on the inner surface of the holder but visible through the light transmissive portion, or provided on the outer or inner surface of the sample vessel but accessible through the Partially visible through light transmission. In some cases, the information storage unit may be provided on the inner surface of the sample vessel, but the sample vessel may be light transmissive so that the information storage unit may be viewed through the sample vessel and/or the light transmissive portion.

Alternatively, the information storage unit may be a QR code, barcode or other optical information storage unit that may be optically visible, such as but not limited to being optically visible from outside the sample collection device. The QR code may be visible through an optical window, hole, etc. in the bottom of the holder of the sample collection device. A QR code can be provided on the sample collection device holder or on a portion of the sample vessel that is visible through the holder. Image capture devices such as cameras or scanners may be provided outside the sample vessel or shipping container and may be capable of reading QR codes.

In some embodiments, single or multiple QR codes or other information storage units may be provided on the sample collection device. In some cases, each sample vessel may have at least one information storage unit, such as a QR code associated therewith. In one example, at least one window may be provided in the holder for each sample vessel, and each window may allow a user to view a QR code or other information storage unit. For example, two sample vessels may be housed within the holder, each of the sample vessels having an associated information storage unit identifiable from outside the holder.

In some embodiments, the information storage unit may be provided with the sample vessel held by the holder. Separating the holder from the rest of the sample collection device can cause the sample vessel to separate from the rest of the sample collection device. The sample vessel can remain in the holder or can be removed from the holder. The information storage unit can remain with the sample vessel even if the sample vessel is removed from the holder. Alternatively, the information storage unit may remain with the holder even if the sample vessel is removed. In some cases, both the holder and the sample vessel can have an information storage unit so that the sample vessel and holder can be tracked and/or matched individually even when separated.

In some cases, any number of sample vessels may be provided within the sample collection device. Some embodiments may connect all of these sample vessels to the sample collection device all at once. Alternatively, the sample vessels can be coupled in a sequential manner or in other non-simultaneous manners. The sample vessel may be capable of receiving a sample received from the subject. Each sample vessel may optionally have a unique information storage unit. A unique information storage unit can be associated with any information related to a sample, subject, device, or components of a device.

In some cases, each information storage unit of each sample vessel may be unique, or contain unique information. In other embodiments, the information storage units on the sample vessel need not be unique. Optionally, some embodiments may have information that is unique to the device, to the subject, and/or to the sample type. In some embodiments, the information on the information storage unit can be used to associate several sample vessels with the same subject or the same information.

In some embodiments, the information storage unit is attached to or otherwise associated (physically or through a non-physical association such as a database pointer or link) to the sample vessel or group of sample vessels at the time of the collection appointment. If associated by group, the association can be based on all from the same user or other factors as set forth herein. Optionally, some embodiments may already have an information storage unit on the sample vessel or groups of sample vessels. In one non-limiting example, the information storage unit provides marker information, which in turn is associated with the subject at or near the time of sample collection. In this example, the information on the information storage unit remains unchanged but is then linked to the subject. In another embodiment, the information on the information storage unit is changed to include information about the subject. Optionally, some embodiments may be both, where some information is changed and some information is unchanged (but may then be associated with the subject or other information about the collection event, such as time and date).

Referring to Figures 19A-19C, various embodiments of the front end of the sample collection device will now be described. Figure 19A shows a top view of the front end of the sample collection device having openings 1103 and 1105 for its respective channels. In this embodiment, the openings 1103 and 1105 are placed in close proximity to each other, with a partition wall 1910 between the openings 1103 and 1105. In one non-limiting example, the thickness of the partition wall 1910 is set to a minimum thickness that can be reliably formed by the manufacturing process used to form the sample collection device. In one embodiment, the wall thickness should be about 1-10 mm. In some embodiments, openings 1103 and 1105 may be in an over-the-top configuration, a diagonal configuration, or other configuration in which the two openings are in close proximity to each other, instead of a side-by-side configuration.

Referring now to Figure 19B, this embodiment shows openings 1910 and 1912 configured to be coaxial with respect to each other. Such a coaxial configuration of openings 1910 and 1912 allows for greater overlap between the two openings.

Referring now to Figure 19C, this embodiment is similar to the embodiment of Figure 19B except that the openings 1920 and 1922 are circular rather than square. It should be understood that any of a variety of shapes may be used, including but not limited to circles, ovals, triangles, quadrilaterals (eg, squares, rectangles, trapezoids), pentagons, hexagons, octagons, or any other cross-sectional shape . Of course, it should be understood that different shapes may be used for each opening and the collection device need not have the same cross-sectional shape for all openings. Some embodiments may have one cross-sectional shape for the opening, but a different cross-sectional shape for the channel downstream of the opening.

Single channel sample collection device

Referring now to Figures 20A-20B, although embodiments herein are generally described as a sample collection device having two separate channels, it should be understood that some embodiments may use a single entry channel 2010. The single entry channel 2010 may or may not be coated. Suitable coatings include, but are not limited to, anticoagulants, plasmas, or other materials.

20A shows that in this embodiment of the sample collection device 2000, a tissue penetrating member 2112 can be installed coaxially within the single access passage 2010. This allows the wound at the target tissue to be formed in a manner that will align with the single access pathway 2010. The tissue penetrating member 2012 may be activated by one of a variety of techniques, such as, but not limited to, actuation when a trigger is depressed, actuation when the front end of the device is in contact with the target tissue, or once the device is depressed with sufficient pressure. On the target tissue it is actuated by pressure. After actuation, the tissue penetrating member 2012 can remain in the single access pathway 2010. Optionally, the tissue penetrating member 2012 can be retracted from the single access passage 2010.

Sample fluid entering the sample collection device 2000 may be split from a single entry passage 2010 into two or more separate passages 2014 and 2016. This enables the sample fluid to be divided into at least two parts from the sample collected at a single point of contact. The two parts may optionally be held in two separate holding chambers 2018 and 2020. These chambers may each have one or more adapter channels 2022 and 2024 to transfer sample fluids to vessels such as, but not limited to, vessels 1146a and 1146b. It should be appreciated that the holding chambers 2018 and 2020 and/or the vessels 1146a and 1146b may contain anticoagulants therein to prepare the sample fluid for processing.

Referring now to FIG. 20B , the present embodiment shows a single access pathway 2010 having a tissue penetrating member 2012 therein that is configured to remain in the single access pathway 2010 in whole or in part after actuation Inside. It should be understood that this embodiment may use a solid penetrating member or a hollow penetrating member having a lumen therein.

Referring to Figure 21, yet another embodiment of a sample collection device 2030 will now be described. This embodiment shows a single access passageway 2032 having a reduced length of tissue penetrating member 2012 configured to extend outwardly from passageway 2032. After actuation, the tissue penetrating member 2012 may be located in the passageway 2032, or alternatively, retracted out of the passageway 2032. Sample fluid entering the sample collection device 2030 may be split from a single entry passage 2032 into two or more separate passages 2034 and 2036. This enables the sample fluid to be divided into at least two parts from the sample collected at a single point of contact. This embodiment shows passages 2034 and 2036 remaining in a capillary channel configuration and not expanding to become chambers, such as the embodiment of Figures 20A-20B. It should be understood that any of the embodiments herein may include one or more fill indicators for the collection pathway and/or vessels on the device so that the user can know when an adequate fill level has been reached.

It will be appreciated that due to the small sample volumes collected with vessels such as, but not limited to, vessels 1146a and 1146b, the "pull" from reduced pressure in the vessels, such as but not limited to vacuum pressure, is minimally possible to make Either the vessel or other lumen from which the sample fluid is collected collapses or is detrimentally remodeled, or is not delivered to the subject. For example, pediatric patients and geriatric patients often have small and/or fragile veins that, when using traditional high volume vacuum vessels, due to the higher vacuum forces associated with drawing larger sample volumes into those traditional vessels, the Veins may collapse. In at least one embodiment of the device, since it does not apply a vacuum (suction) force to the vein, it will not have such a problem. In one embodiment, the amount of vacuum force draws no more than 120 uL of sample fluid into vessel 1146a. Optionally, the amount of vacuum force draws no more than 100 uL into vessel 1146a. Optionally, the amount of vacuum force draws no more than 80 uL into vessel 1146a. Optionally, the amount of vacuum force drawn into the vessel 1146a does not exceed 60 uL. Optionally, the amount of vacuum force drawn into the vessel 1146a does not exceed 40 uL. Optionally, the amount of vacuum force draws no more than 20 uL into vessel 1146a. In one embodiment, this type of aspiration is performed without the use of a syringe and is primarily based on the pulling force from the vessel and any force from the fluid exiting the subject. Optionally, shaped passages through the device to draw samples that have reached the interior of the device can assist in reducing force transmission from vessels 1146a and 1146b to the subject's blood vessels or other body lumens. Some embodiments may use about three-quarters vacuum or less in the small volume vessels listed above to minimize hemolysis of the sample and prevent the collapse of blood vessels in the subject. Some embodiments may use about one-half vacuum or less in the small volume vessels listed above to minimize hemolysis of the sample and prevent the collapse of blood vessels in the subject. Some embodiments may use about a quarter vacuum or less in the small volume vessels listed above to minimize hemolysis of the sample and prevent the collapse of blood vessels in the subject. The vacuum herein is a complete vacuum relative to atmospheric pressure.

It will be appreciated that in one embodiment, the cross-sectional area of the chamber in the device is greater than the cross-sectional diameter of the needle and/or flexible conduit used to draw bodily fluids from the subject. This further assists in reducing force transmission to the subject. The vacuum pull from the vessel most directly draws the liquid sample in the device and not directly the sample in the needle that is closer to the subject. The longer pathway is buffered by a larger volume chamber in the collection device, which inhibits pulling on the blood vessels in the subject. In addition, the initial peak pull force is greatly reduced in the small volume vessel relative to the larger volume vessel also under vacuum. The duration of the "pull" will also be longer to allow a larger amount of sample to enter the vessel. In smaller volumes, a significant portion of the sample to be collected is already in the device, and there is less sample drawn from the subject that was not already in the device before starting the sample pull.

Referring to Figure 22, yet another embodiment of a sample collection device will now be described. This embodiment shows a collection device 2100 having a connector 2102, such as, but not limited to, a Luer connector that allows connection to a variety of sample collection devices such as tissue penetrating members, needles, and the like. Some luer connectors may use a press fit to engage other connectors, while some embodiments of the connector 2102 may include threads to facilitate engagement. 22 shows that in this current embodiment, the butterfly needle 2104 is coupled to a fluid connection passage 2106, such as, but not limited to, a flexible tube leading to a connector 2108, to connect the sample acquisition feature to the sample collection device 2100. The flexible conduit 2106 allows the needle portion 2104 to be positioned away from the sample collection device 2100 but still be operatively fluidly coupled to the sample collection device 2100. This allows for more flexibility in the positioning of the needle 2104 to collect sample fluid without also having to move the sample collection device 2100. Alternatively, some embodiments may couple the tissue penetrating member directly to the device 2100 without the use of flexible tubing.

At least some or all embodiments may have a fill indicator, such as but not limited to a viewing window or opening, that shows when a sample is present within the collection device and thus indicates that it is acceptable to engage one or more sample vessels. Optionally, embodiments without a fill indicator are not excluded. Some embodiments may optionally include one or more vent holes, such as but not limited to ports, to allow air to escape when the channels in the collection device are filled with sample. In most embodiments, one or more filled sample vessels can be disconnected from the sample collection device after the desired fill level is reached. Optionally, one or more additional sample vessels may be coupled to the sample collection device to collect additional quantities of bodily fluid samples. Optionally, the internal condition of the sample vessel is such that the vessel has a reduced pressure and is thus configured to draw only a predetermined amount of sample fluid.

FIG. 23 shows an exploded view of one embodiment of a sample collection device 2100. In this non-limiting example, the portion 1130 may be configured to hold the vessel holder 1140 and the portion with the sampling device holder 2160. The device 2100 can include a leak prevention device 2162 that can engage the open ends of the adapter channels 2022 and 2024 to minimize sample loss through the open ends until the vessel in the holder 1140 is engaged to either or Aspirate samples from multiple vessels. In the current embodiment, the containment device 2162 covers the at least two adapter channels 2022 and 2024 and is configured to be removable. This embodiment of leak containment device 2162 is sized such that it can be moved to expose openings in adapter channels 2022 and 2024, while still allowing adapter channels 2022 and 2024 to engage one or more vessels in holder 1140.

Referring now to Figures 24 and 25, one embodiment of a sampling device holder 2160 is shown in greater detail. Figure 24 shows the sampling device holder 2160 as an assembled unit. FIG. 25 shows an exploded view of sampling device holder 2160 with first portion 2164 and second portion 2166. Adapter channels 2022 and 2024 are also shown as removable from second portion 2166. Although this embodiment of the sampling device holder 2160 is shown as two separate parts, it should be understood that some alternative embodiments may configure the sample device holder 2160 as a single integral unit. Alternatively, some embodiments may be configured with more than two sections that are assembled together to form the retainer 2160. Alternatively, some embodiments may create separate sections along the longitudinal axis 2165 or other axis of the retainer 2160 rather than along the lateral axis of the retainer 2160, as shown by the dividing line in FIG. 25 .

Referring now to Figures 26-28, various cross-sectional views of embodiments of sample device holder 2160 and device 2100 are shown. 26 shows a cross-sectional view of portion 2164 and portion 2166. While not being bound by any particular theory, the use of separate sections 2164 and 2166 may be chosen to simplify fabrication, particularly for forming the various internal channels and chambers in retainer 2160. For example, at least one wall 2167 of the chamber can be formed in the first portion 2164, while a complementary wall 2168 of the chamber can be formed in the second portion 2166. Figure 27 shows a top end view of portion 2166 from which wall 2168 can be seen.

Referring to Figure 28, a cross-sectional view of the assembly device 2100 will now be described. 28 shows that a sample entering the device through the connector 2102 will enter the common chamber 2170 before being passed to the adapter channels 2022 and 2024. From adapter channels 2022 and 2024, movement of holder 1140 in the direction indicated by arrow 2172 will operatively fluidly couple vessels 1146a and 1146b to adapter channels 2022 and 2024, thereby moving the sample from the channels into the vessels. In this embodiment, there is sufficient space 2174 to allow movement of the vessels 1146a and 1146b for the adapter channels 2022 and 2024 to penetrate the caps of the vessels 1146a and 1146b so that the adapter channels 2022 and 2024 communicate with the internal fluids of the vessels 1146a and 1146b Connected. Although only two sets of vessels and adapter channels are shown in the figures, it should be understood that other configurations with more or fewer sets of vessels and adapter channels may also be configured for use with devices such as those shown in FIG. 28 . use together.

Modular sample collection device

29A-29C, although embodiments herein generally describe a sample collection device as having an adapter channel for connecting the sample collection channel with a vessel, it should be understood that embodiments without such a configuration are not excluded.

Taking the non-limiting example in Figure 29A, as previously proposed herein, some embodiments may not have discrete, separate adapter channels. Here, the collection channel 2422 may be directly connected to the vessel 2446 by means of relative movement between one or both of these elements as indicated by arrow 2449.

By way of the non-limiting example in Figure 29B, one or more adapter channels 2454 may be discrete components that are not initially in direct fluid communication with either collection channel 2422 or vessel 2446. Here, the collection channel 2422 may be connected to the vessel 2446 by means of relative movement (sequentially or simultaneously) between the collection channel, one or more adapter channels 2454, or one or more of the vessels 2446 to create a secondary channel from the collection channel. A fluid pathway into the vessel through the one or more adapter channels.

By way of the non-limiting example in Figure 29C, the one or more adapter channels 2454 may be the elements that initially contact the vessel 2446. The adapter channel 2454 may not communicate directly with the interior of the vessel. Here, the collection channel 2400 may be connected to the vessel by means of relative movement between one or more of those elements (sequentially or simultaneously) to create access from the collection channel to the vessel through the one or more adapter channels in the fluid passage. Some embodiments may have a septum, sleeve, sleeve with drain or cover 2455 on one end of the collection channel that will be engaged by the adapter channel. Engagement of the various elements may also move the adapter channel 2454 into the interior of the vessel 2446, as the adapter channel 2454 may not be in fluid communication with the interior initially. Some embodiments herein may have more than one adapter channel, and some embodiments may use adapter channels with sharp ends at both ends of the channel. Variations and substitutions are possible for the embodiments described herein, and no single embodiment should be construed as encompassing the entire invention.

It should be understood that any of the embodiments herein may be modified to include the features set forth in the description with respect to Figures 29A-29C.

Sample processing

Referring to Figure 30, one embodiment of a body fluid sample collection and transport system will now be described. Figure 30 shows a body fluid sample B on a skin surface S of a subject. In the non-limiting example of Figure 30, body fluid sample B may be collected by one of a variety of devices. By way of non-limiting example, collection device 1530 may be, but is not limited to, those described in US Patent Application Serial No. 61/697,797, filed September 6, 2012, which is incorporated by reference in its entirety. This is for all purposes. In this embodiment, bodily fluid sample B is collected by one or more capillary channels and then directed into sample vessel 1540. By way of non-limiting example, at least one of the sample vessels 1540 may have an interior initially under partial vacuum for drawing a bodily fluid sample into the sample vessel 1540. Some embodiments may simultaneously draw the sample from the sample collection device into the sample vessel 1540 from the same or different collection channels in the sample collection device. Alternatively, some embodiments may simultaneously draw the sample into the sample vessel.

In this embodiment, the sample vessel 1540 in its holder 1542 (or alternatively, removed from its holder 1542) is loaded into the shipping container 1500 after the body fluid sample is within the sample vessel 1540. In this embodiment, there may be one or more slots sized for the sample vessel holder 1542, or slots for the sample vessels in the shipping container 1500. By way of non-limiting example, the wells may hold sample vessels in an array configuration and be oriented vertically or some other predetermined orientation. It will be appreciated that some embodiments of the sample vessels 1540 are configured such that they hold different amounts of sample in each vessel. By way of non-limiting example, this can be controlled based on the amount of vacuum force in each sample vessel, the amount of sample collected in one or more sample collection channels of the collection device, and/or other factors. Optionally, there may also be different pretreatments in the sample vessel, such as, but not limited to, different anticoagulants and the like.

As seen in Figure 30, the sample vessel 1540 is collecting a sample at a first location, such as but not limited to a sample collection site. By way of non-limiting example, the bodily fluid sample is then transported in shipping container 1500 to a second location, such as, but not limited to, a receiving site, such as, but not limited to, an analysis site. The shipping method can be by courier, postal courier or other shipping technology. In many embodiments, shipping can be accomplished by having a further vessel in which the shipping container is housed. In one embodiment, the sample collection site may be a point of care. Optionally, the sample collection site is a service point. Optionally, the sample collection site is remote from the sample analysis site.

Although the present embodiment of FIG. 30 shows the collection of bodily fluid samples from the surface of the subject, other alternative embodiments may use collection techniques for collecting samples from other areas of the subject, such as by venipuncture, to fill one or more sample vessels 1540. Such other collection techniques are not excluded from being used as an alternative to or in combination with surface collection. Surface collection can be on the outer surface of the subject. Alternatively, some embodiments may be collected from accessible surfaces in the subject. The presence of bodily fluid sample B on these surfaces can occur naturally or through wound creation or other techniques that make the bodily fluid surface accessible.

Referring now to Figure 31, there is described yet another embodiment in which a sample of bodily fluid can be collected from a subject as opposed to collecting a sample pooled on the subject's surface. This embodiment of Figure 31 shows a collection device 1550 having a hypodermic needle 1552 configured to collect a sample of bodily fluid, such as, but not limited to, venous blood. In one embodiment, a bodily fluid sample can fill chamber 1554 in device 1550, at which point one or more sample vessels 1540 can be engaged to draw the sample into the corresponding one or more vessels. Alternatively, some embodiments may have no chamber 1554, but instead one or more channels, one or more passages, or one or more tubes for directing the sample from the needle 1552 to the one or more sample vessels 1540. There is very little free space outside. For bodily fluid samples such as blood, the pressure from within the blood vessel is such that the blood sample can fill chamber 1554 without much (if any) assistance from the collection device. Such embodiments may optionally include one or more vent holes, such as but not limited to ports, to allow air to escape when the channels in the collection device are filled with sample. Optionally, some embodiments may have a direct needle attachment to the collection device 1550 (rather than a conduit connection to the needle), similar to that shown in Figure 44, where the needle is rigidly or substantially rigidly connected to the collection device. Some embodiments may have removable connections, releasable connections, Luer connections, threaded connections, or other pin connection technologies that may be developed in the future.

At least some or all embodiments may have a fill indicator, such as but not limited to a viewing window or opening, that shows when a sample is present within the collection device and thereby indicates that it is acceptable to engage one or more sample vessels 1540. Optionally, embodiments without a fill indicator are not excluded. After the desired fill level is reached, one or more filled sample vessels 1540 can be disconnected from the sample collection device. Optionally, one or more additional sample vessels 1540 can be coupled to the sample collection device 1550 (or 1530) to collect additional quantities of bodily fluid samples.

point of service system

Referring now to Figure 32, it should be understood that the processes described herein may be performed using automated techniques. Automated processing can be used in integrated, automated systems. In some embodiments, this may be a single instrument with multiple functional components therein and surrounded by a common housing. Treatment techniques and methods for settlement measures can be preset. Alternatively, it can be based on a protocol or procedure that can be dynamically changed in the manner described in U.S. Patent Application Serial Nos. 13/355,458 and 13/244,947, which are incorporated herein by reference in their entirety for all purposes.

In one non-limiting example, as shown in Figure 32, the integrated instrument 2500 may be equipped with a programmable processor 2502, which may be used to control various components of the instrument. For example, in one embodiment, the processor 2502 can control a single or multiple pipette system 2504 that can move in the X-Y and Z directions as indicated by arrows 2506 and 2508. The same processor or a different processor may also control other components 2512, 2514 or 2516 in the instrument. In one embodiment, the type of assembly 2512, 2514 or 2516 includes a centrifuge.

As seen in FIG. 32, control by the processor 2502 can allow the pipette system 2504 to collect a blood sample from the cartridge 2510 and move the sample to one of the assemblies 2512, 2514 or 2516. Such movement may involve dispensing samples into removable vessels in cartridge 2510, and then transporting the removable vessels to one of assemblies 2512, 2514, or 2516. Alternatively, the blood sample is dispensed directly into a vessel already mounted on one of the assemblies 2512, 2514 or 2516. In one non-limiting example, one of these components 2512, 2514, or 2516 may be a centrifuge with an imaging configuration to allow illumination and visualization of the sample in the vessel. Other components 2512, 2514 or 2516 perform other analysis, assay or detection functions.

All of the foregoing can be integrated into a single housing 2520 and configured for countertop or small footprint floor installation. In one example, a small footprint ground mounted system may occupy a floor area of about ^4m2 or less. In one example, a small footprint floor mounted system may occupy a floor area of about 3 m ² or less. In one example, a small footprint floor mounted system may occupy a floor area of about 2 ^m2 or less. In one example, a small footprint floor mounted system may occupy a floor area of about 1 m ² or less. In some embodiments, the instrument footprint may be less ^than or equal to about ^4m2 , 3m2, ^2.5m2 , ^2m2 , ^1.5m2 , ^1m2 , ^0.75m2 , ^0.5m2 , ^0.3m2 , ^0.2m2 , ^0.1m2 , ^0.08m2 , ^0.05m2 , ^0.03m2 , ^100cm2 , ^80cm2 , ^70cm2 , ^60cm2 , ^50cm2 , ^40cm2 , ^30cm2 , ^20cm2 , ^15cm2 or ^10cm2 . Some suitable systems in a point-of-service environment are described in US Patent Application Serial Nos. 13/355,458 and 13/244,947, all of which are hereby incorporated by reference in their entirety for all purposes. This embodiment can be configured for use with any of the modules or systems described in these patent applications.

Referring to Figures 33-37, further embodiments of the sample collection device will now be described. As seen in Figures 33 and 34, at least one embodiment shows a sample collection region 2600 having a capillary channel region and then a lower flow resistance region 2610 that increases the cross-sectional area of the channel to provide lower flow resistance and increased flow rate. In at least one embodiment, the lower flow resistance region 2610 is still a capillary channel, but a capillary channel with lower flow resistance. Alternatively, other embodiments may increase the size in which the sample flows, but not by capillary action. Channels of increased size can also be used to store samples therein. By way of non-limiting example, such storage may be temporary during collection, may be longer term, such as for transport from collection site to refrigeration, from collection site to receiving site, other location-to-location transport, or other Purpose. One embodiment can be configured to have caps mounted on both ends of the device so that the sample is contained therein without being transferred to vessels 1146a and 1146b.

This also reduces the amount of adhesive material used to join the items together, since the junction between regions 2600 and 2610 can be located across the midline 2620. It should be appreciated that embodiments may have channels 2612 and 2614 that have the same cross-sectional size and/or are configured to contain the same or substantially the same volume in the channels. Alternatively, channels 2612 and 2614 may be configured to accommodate different volumes. The same may be true for the channel as it continues into region 2610. Alternatively, some embodiments may have different sizes when in region 2610 and the same size in region 2600, or vice versa. Other size configurations are not excluded. Although the channels are shown here as straight, it should be understood that, for any of the embodiments disclosed herein, some embodiments may have curved or other non-straight portions of one or more of the channels.

Other components are similar to those previously described herein with respect to vessels 1146a and 1146b, adapter channels, frits, retainer 130, and the like. Wicking at the junction for both channels (fill time less than 6 seconds) was improved (steps removed) and blood easily entered the channel and passed through the junction area without tilting. Parts can be made of PMMA, PET, PETG, etc. In this embodiment, this can provide 7.5 times faster filling relative to a cross-sectional sized capillary channel, since increasing the channel size in region 2610 will allow easier flow into that region.

The flow resistance in region 2610 decreases to the fourth power based on the change in channel size, as seen in the following formula:

It will be appreciated that once there is a desired amount of sample in one or more channels, some embodiments can be configured such that the sample can be manipulated into a storage vessel. By way of non-limiting example, such movement of the sample may be by pulling, pushing, or both. In one embodiment, the pulling force may be provided by a vessel with a vacuum therein, a vessel with a plunger or other movable surface that moves to increase the volume and draw a sample therein, or an active vacuum force. In one embodiment, the thrust may be the pressure from air or other gas provided from behind a bolus or other fluid grouping. In embodiments, compressed gas, pressure from a cap with a seal around the device that slides over the collection device, a syringe coupled to one end and applying air pressure, or other force may be applied to urge the gas forward. The force provided can be different from the power used to collect the sample in one or more channels. Alternatively, some embodiments may use different powers per channel. Alternatively, some embodiments may use a different power in zone 2600 relative to zone 2610.

While the present teachings have been described and illustrated with reference to certain specific embodiments thereof, it will be apparent to those skilled in the art that various modifications, procedures and arrangements can be made without departing from the spirit and scope of the invention. Alter, modify, substitute, delete or add. For example, with respect to any of the above embodiments, it should be understood that the fluid sample may be whole blood, diluted blood, tissue fluid, a sample collected directly from a patient, a sample located on a surface, a sample after some pretreatment, and the like. Those skilled in the art will appreciate that alternative embodiments may have more than one vessel, which may be sequentially operably coupled to the needle or opening of the channel to draw fluid into the vessel. Optionally, some embodiments may have vessels configured to be operably coupled to the channels simultaneously. Some embodiments may integrate a lancing device or other wound creation device with a sample collection device to bring a target sample fluid to the tissue surface and then collect the sample fluid, all using a single device. By way of non-limiting example, a spring-actuated, mechanically-actuated, and/or electromechanically-actuated tissue penetrating member can be mounted to have a penetrating tip exiting near one end of the sample collection device near the sample collection channel opening. , so that the wound site created will also be along the same end of the device as the collection opening. Alternatively, the integrated device may have a collection opening on one surface of the device, and tissue penetrating elements along the other surface. In any of the embodiments disclosed herein, the first opening of the collection channel may have a blunt shape that is configured not to easily pierce human skin.

Additionally, the use of a heat patch on the finger or other target tissue can increase blood flow to the target area and thereby increase the rate at which sufficient blood or other body fluids can be drawn from the subject. Heating is used to raise the target tissue to about 40C to 50C. Optionally, the heat raises the target tissue to a temperature in the range of about 44 to 47C.

Furthermore, those skilled in the art will recognize that any of the embodiments as described herein may be applicable to the collection of sample fluids from humans, animals or other subjects. Some embodiments as described herein may also be suitable for the collection of non-biological fluid samples. Some embodiments may use vessels that are not removable from the carrier. Some embodiments may direct the fluid sample after being metered in the sample collection portion by the second power to a cartridge, which is then placed in the analyte or other analytical device. Optionally, it should be understood that while many embodiments show the vessel in a carrier, embodiments in which the vessel is bare or not mounted in the carrier are not excluded. Some embodiments may have a vessel separate from the device and only brought into fluid communication if the channel has reached a minimum fill level. For example, the vessel can be held in various locations and only accessed by a technician when a sufficient amount of blood or sample fluid is in the sample collection device. At this point, the vessels can be brought into fluid communication with one or more of the channels of the sample collection device simultaneously or sequentially.

Additionally, concentrations, amounts, and other numerical data may be presented herein in a range format. It is to be understood that such range format is used only for convenience and brevity, and is to be flexibly interpreted to include not only the values expressly stated as the limits of the range, but also the individual values or sub-ranges subsumed within the range , as if each value and subrange were explicitly stated. For example, a size range of about 1 nm to about 200 nm should be construed to include not only the expressly stated boundaries of about 1 nm and about 200 nm, but also individual sizes such as 2 nm, 3 nm, 4 nm, and subranges such as 10 nm to 50 nm, 20 nm to 100 nm, etc.

shipping container

Referring now to Figures 38A-38B, there are shown exploded perspective views of one non-limiting example of a shipping container 3200 provided in accordance with one embodiment described herein. It should be appreciated that the shipping container 3200 may be configured to have one or more features of any other shipping container described elsewhere herein. By way of non-limiting example, shipping container 3200 may facilitate shipping one or more sample vessels therein. In some embodiments, the transport container 3200 provides a thermally controlled interior area to minimize undesired thermal decomposition of the sample during transport of the sample to another location, such as, but not limited to, an analytical facility. It should be understood that the shipping container may be placed within one or more other vessels during shipping.

In one embodiment, the sample vessel may be provided from a sample collection device that collects a sample of the body fluid. By way of non-limiting example, the sample vessel may contain the sample in liquid form therein. In most embodiments, liquid forms also include embodiments that are suspensions.

By way of non-limiting example, shipping container 3200 may have any size. In some cases, the shipping container 3200 can have less than or equal to about 1 m ³ , 0.5 m ³ , 0.1 m ³ , 0.05 m ³ , 0.01 m ³ , 1000 cm ³ , 500 cm ³ , 300 cm ³ , 200 cm ³ , 150 cm ³ , 100 cm ³ , ^70cm3 , ^50cm3 , ^30cm3 , ^20cm3 , ^15cm3 , ^10cm3 , ^7cm3 , ^5cm3 , ^3cm3 , ^2cm3 , ^1.5cm3 , ^1cm3 , ^700mm3 , ^500mm3 , ^300mm3 , ^100mm3 , 50mm ³ , 30mm ³ , 10mm ³ , 5mm ³ or 1mm ³ total volume. The footprint and/or maximum cross-sectional area of the shipping container may be less than or equal to about 1 m ² , 0.5 m ² , 0.1 m ² , 0.05 m ² , 100 cm ² , 70 cm ² , 50 cm ² , 30 cm ² , 20 cm ² , 15 cm ² , 10cm ² , 7cm ² , 5cm ² , 3cm ² , 2cm ² , 1.5cm ² , 1cm ² , 70mm ² , 50mm ² , 30mm ² , 10mm ² , 5mm ² or 1 mm ² . In some cases, the shipping container can have a diameter of less than or equal to about 1 m, 75 cm, 50 cm, 30 cm, 25 cm, 20 cm, 15 cm, 12 cm, 10 cm, 9 cm, 8 cm, 7 cm, 6 cm, 5 cm, 4 cm, 3 cm, 2 cm, 1 cm, 0.7 cm Dimensions in cm, 0.5 cm, 0.3 cm or 1 mm (eg height, width, length, diagonal or perimeter). In some cases, the largest dimension of the shipping container may be no greater than about 1 m, 75 cm, 50 cm, 30 cm, 25 cm, 20 cm, 15 cm, 12 cm, 10 cm, 9 cm, 8 cm, 7 cm, 6 cm, 5 cm, 4 cm, 3 cm, 2 cm, 1 cm , 0.7cm, 0.5cm, 0.3cm or 1mm.

Optionally, the shipping container may be lightweight. In some embodiments, the weight of the shipping container with or without the sample vessel therein may be less than or equal to about 10 kg, 5 kg, 4 kg, 3 kg, 2 kg, 1.5 kg, 1 kg, 0.7 kg, 0.5 kg, 0.3 kg, 100g, 70g, 50g, 30g, 20g, 15g, 10g, 7g, 5g, 3g, 2g, 1g, 500mg, 300mg, 200mg, 100mg, 70mg, 50mg, 30mg, 10mg, 5mg or 1mg.

As seen in Figures 38A and 38B, one embodiment of a shipping container may have a top cover 3210, a housing 3220 for the thermal regulation device, one or more insertion trays 3230a, 3230b for the shipping container, and a bottom plate 3240 .

In one embodiment, the top cover 3210 has a substantially flat shape, although other shapes are not excluded. The top cover 3210 may cover thermal conditioning devices such as, but not limited to, heaters or coolers contained in the shipping container. The top cover may or may not have the same footprint as the housing 3220 for the thermal regulation device. A cooler, heater, or other thermal conditioning device 3220 may be provided within the shipping container 3200. Optionally, the device 3220 may be an active unit or a passive unit. The thermal conditioning device can maintain the sample vessel within the shipping container 3200 at a desired temperature or below a predetermined threshold temperature. Alternatively, the thermal regulation device may be any temperature control unit known in the art. Optionally, the thermal regulation device may be capable of heating and/or cooling. Alternatively, the thermal regulation device may be a thermoelectric cooler. Alternatively, the thermal regulation device may be enclosed between the top cover and the housing for the cooler.

Alternatively, the top cover and housing may or may not form an airtight seal. The top cover and/or housing may be formed from a material having the desired thermal conductivity. For example, housing 3220 may have selectable thermal conductivities. In one embodiment, the housing may include an embedded phase change material (PCM) within the case material, so that the temperature is substantially uniform everywhere. PCM has a very good temperature profile. It is desirable not to cause subcooling of the sample, such as associated with ice, which could create negative drops as low as -5°C. The PCM can be configured to control the temperature range above freezing. By way of non-limiting example, thermal conductivity may be in the range between about 100-250 W/m/K (Watts/meter/Kelvin). Optionally, each sample vessel will be in contact with the PCM. Some embodiments may have one PCM for each layer. PCM material can be flow molded into shipping container material. Optionally, there may be compartments of PCM material. Optionally, PCM can be used to fill the gaps in the tray. PCM can provide passive thermal control technology.

Alternatively, the PCM can be incorporated into the injection molding material. In such an embodiment, the entire vessel may be the cooling medium. This also prevents leakage of PCM from the compartment in the shipping container. The size of the shipping container can also be reduced when the PCM is directly integrated into the shipping container material. The energy density is greater due to the increased storage capacity per unit mass. Mixing plastic with PCM material can be configured to provide both strength and cooling. By way of non-limiting example, 30% of the material may be PCM and the remainder be plastic providing stiffness. By way of non-limiting example, between 20% and 40% of the material may be PCM, with the remainder being another material, such as, but not limited to, plastic that provides mechanical stiffness. Some embodiments may use a blow-molded exterior filled with PCM or other materials. The interior can be formed using different techniques, as it may not be critical that the interior is visually appealing. Alternatively, cast molding or other lower temperature molding processes may also be used in place of or in combination with injection molding of PCM-integrated shipping container materials. The embedded PCM can also be in a tray. Some embodiments may be trays that are much more thermally conductive to achieve a uniform, consistent cooling profile. Optionally, the PCM material is contained in a chamber within the chassis of the shipping container, wherein the walls of the chamber may be thinner than the wall thicknesses of other areas of the chassis of the shipping container.

In one embodiment, the shipping container 3200 can also configure each of the trays 3230a and 3230b so that any information storage units on the sample vessels can be easily read without having to remove the sample vessels from the trays 3230a and 3230b. In one example, the holder has an opening at the bottom that allows the information storage unit on the bottom to be visible while the sample vessels are still in trays 3230a and 3230b.

FIG. 39 shows various views of shipping container 3200 . Some views show that the sample vessel holder in tray 3230a or 3230b can have an open bottom so that any information storage units, such as But not limited to barcodes or other information storage units. Optionally, only certain portions of the shipping container 3200 (such as but not limited to layers, pallets, etc.) are removed to obtain the desired information. Optionally, a barcode or other information storage unit may be accessed through one or more openings in the tray. This allows barcode scanning of very small shipping containers. Alternatively, rows of sample vessels can be scanned individually, or the entire tray can be scanned all at once. Optionally, the user can see all sample vessel holders. Optionally, the computer vision system can also scan to see if steps such as centrifugation are complete. This can be at either end of the shipping process. The computer vision system can visualize the sample vessel and determine whether the sample there is in a form that confirms completion of the desired step. If it detects an error, the system may inform the user or the system of the problem and/or re-execute the missed and/or incorrectly performed steps. Alternatively, the holder may have a closed bottom and the information may be on the side or other surface of the shipping container 3200.

In some embodiments, the shape of the holder can also be designed to follow the contour of the sample vessel 3134 located therein, thereby increasing the contact surface area and improving thermal control of the sample vessel. Alternatively, thermal control of the sample vessel can occur through heat transfer with the tray and/or the PCM, but not in direct contact with the PCM. Optionally, some sample vessels 3134 may also be in direct contact with the vessel and/or the PCM. The sample vessel and/or holder openings can be in a straight row, in a honeycomb pattern, or in another pattern.

Referring now to Figures 40A and 40B, a fully assembled shipping container 3200 is shown. Figure 40B shows a plurality of sample vessels 3134, such as those associated with the sample collection device. The sample vessels 3134 may all be from samples associated with one subject, in which case the information storage unit associated with the tray 3230a may be used to provide information about the set of samples. Alternatively, the individual sample vessels may each still have the same information storage unit as that of the tray 3230a, or they may each be unique. Some embodiments may insert sample vessels from multiple subjects into the same tray 3230a. Alternatively, some embodiments may only partially fill each tray. Some embodiments may fill every opening in the tray, but not every sample vessel will have a sample therein (i.e., some sample vessels may be empty sample vessels that are inserted to provide uniform heat distribution). These stackable trays 3230a may have closures that couple the trays together using elements such as, but not limited to, magnets, mechanical latches, or other coupling mechanisms. In some embodiments, magnets may be used to engage trays containing sample vessels to support ease of opening during automated loading and unloading processes. Optionally, the user may not remove the pallet from the shipping container. Alternatively, the user may not remove the pallet from the shipping container without using a tool to release the pallet. Some embodiments have a key mechanism (magnetic or other technology). In this way, the patient service center can put in the sample but not take it out. Optionally, some embodiments may have selected shaped openings so that an individual cannot place the sample vessel and/or its holder in the wrong way, in order to prevent user error.

In one embodiment, loading and/or unloading may occur in a temperature-regulated room or chamber to maintain the sample in a desired temperature range. In one embodiment, it is desirable to have a temperature range between about 1°C and 10°C. Alternatively, it is desirable to have a temperature range between about 2°C and 8°C. Alternatively, it is desirable to have a temperature range between about 4°C to 5°C. Optionally, the material of trays 230a and 230b can be used to provide a temperature-controlled atmosphere for the sample vessel. Some embodiments use convection to control heat distribution within shipping container 200.

Figure 40B also shows that in this particular embodiment, there may be grooves 3232 for O-rings or other seals that may provide a tight connection between the layers of the shipping container. The system may also include a closure mechanism 3234, such as, but not limited to, a magnetic closure to hold the stackable insert tray in a desired position. It should be appreciated that some embodiments may have vias 3236 for routing one or more sensors to detect conditions experienced by the stackable insert tray during transport.

Figure 40C shows various perspective views of the embodiment of Figures 40A and 40B when the various components, such as stackable trays and lids, are joined together to form a shipping container 3200. As seen in Figure 40C, the shipping container may include multiple layers of sample vessels or trays with sample vessels. Alternatively, some embodiments may have only a single layer of sample vessels. Some embodiments may use active cooling or thermal control in one or more layers of the shipping container 3200. By way of non-limiting example, one embodiment may have a thermoelectric cooler in the top layer. Alternatively, some embodiments may use a combination of active thermal control and passive thermal control. By way of non-limiting example, an embodiment may have a thermal mass, such as, but not limited to, a phase change material (PCM) that is already at a desired temperature. An active thermal control unit may be included to maintain the PCM in a desired temperature range. Alternatively, some embodiments may use only thermal mass, such as, but not limited to, PCM, to maintain the temperature within the desired range.

Shipping Containers with Removable Pallets

Referring to Figure 41, yet another embodiment of a shipping container will now be described. 41 shows a shipping container 3300 having a thermally controlled interior 3302 that houses a tray 3304 that can hold a plurality of sample vessels 3306 in an array configuration, each of the vessels 3306 in a free-flowing, non-cored The suction format holds the bulk of its sample and has about 1 ml or less of sample fluid in each vessel. Optionally, about 2 ml or less of sample fluid is present in each vessel. Optionally, about 3 ml or less of sample fluid is present in each vessel. In one non-limiting example, the vessels are arranged such that in each transport container there are at least two vessels with sample fluid from the same subject, wherein at least a first sample includes a first anticoagulant and a second The sample includes the second anticoagulant in the matrix.

Although Figure 41 shows sample vessels held in an array configuration, other predetermined configurations are not excluded. Some embodiments may place the sample vessel in a hinged, swinging, or other retention mechanism in the tray, which may allow movement in one or two degrees of freedom. Some embodiments may place the sample vessel into a device that has a first configuration during loading and then assumes a second configuration during transport to hold the sample vessel. Some embodiments may place the sample vessel into a material that has a first material property during loading and then assumes a second configuration (such as, but not limited to, hardening) during transport to hold the sample vessel.

In some embodiments, the sample vessel is in the holder 3310, and the tray 3304 defines an opening and/or cavity sized to fit the holder 3310 rather than the sample vessel. By way of non-limiting example, holders 3310 may be used to physically hold associated vessels 3306 together when they are in trays 3304. Some embodiments have the holder 3310 in direct contact with the tray 3304 in order to protect the vessel from direct contact with the tray 3304. In one non-limiting example, the tray can hold at least 100 vessels, or alternatively, at least 50 holders each having two vessels.

Still referring to Figure 41, this embodiment of the shipping container 3300 may have some sort of retention mechanism 3320, such as, but not limited to, clips, magnetic areas, etc., to retain the tray 3306. The retention mechanism 3320 can be configured to retain the tray 3304 in a manner that can be released when desired. Optionally, retention mechanism 3320 may be configured to retain tray 3304 in a non-releasable manner. In the embodiment shown in FIG. 41 , the retention mechanism 3320 is shown as a magnetic and/or metallic member in the tray 3304 that is attracted to the metallic and/or magnetic member in the shipping container 3300. The pallets 3304 may be configured to be removed from the shipping container 3300 when the shipping container 3300 arrives at the processing facility. This can occur using one or more techniques including, but not limited to, the use of strong magnets to engage magnetic and/or metallic members in the tray 3304. Some embodiments may use clamps, hooks, or other mechanical mechanisms to remove tray 3304 from shipping container 3300. Some embodiments may use a combination of techniques to remove tray 3304. It should also be appreciated that some embodiments may choose to remove the vessel 3306 and/or the holder 3310 while the tray 3304 remains in the shipping container 3300. Some techniques may perform two or more of the foregoing techniques.

It should also be understood that the shipping container 3300 itself may be a cooling device, including thermal control materials such as, but not limited to, ice, PCM, and the like. Other embodiments may incorporate thermal management materials directly into the materials used to form shipping container 3300. As seen in Figure 41, some embodiments of the shipping container 3300 may have a substantially empty space 3324 in which one or more thermal control materials are housed or integrated.

Still referring to FIG. 41 , the shipping container 3300 may also include openings 3330 for attachment of hinges or other attachment means for covering or attachment to other layers of the shipping container 3300. For ease of illustration, the cover and/or connections to the cover or other layers are not shown in FIG. 41 . While some embodiments may use only a single layer, it should be understood that multi-layer embodiments are not excluded.

Referring to Figure 42, an exploded perspective view of yet another embodiment of a shipping container 3400 will now be described. The embodiment of Figure 42 is designed to hold the pallet 3402 within the shipping container interior 3404. The exploded perspective view shows a plurality of vessels 3406 in holders 3410 in tray 3402. Tray 3402 may be configured such that some or all portions of retention mechanism 3420 are similar to retention mechanism 3320 in tray 3402. It should also be appreciated that the tray 3402 may have one or more cutouts, protrusions or features to allow the tray 3402 to be inserted into the interior in a limited number of predetermined orientations. Some embodiments may be configured to support only one orientation of the tray in the vessel. Some embodiments may be configured to support only two possible orientations of the tray in the vessel.

Figure 42 shows that in one embodiment, the shipping container 3400 may be formed from two separate pieces 3430 and 3432. Alternatively, some embodiments may be formed from three or more pieces. Alternatively, some embodiments may be a single piece. Parts 3430 and 3432 may have openings filled by plugs 3434 and 3436. The interior 3438 of the shipping container 3400 can hold thermal control materials such as, but not limited to, ice, phase change materials, and the like. Other embodiments may incorporate thermal management materials directly into the materials used to form shipping container 3400.

In one instance, the interior 3433 of the part 3432 may be filled with a thermal control material such as, but not limited to, PCM. Alternatively, one embodiment may use active thermal control materials, such as but not limited to thermoelectric coolers, to cool the interior.

43, yet another embodiment of a shipping container 3500 will now be described. Figure 43 shows that the shipping container 3500 can include a cover 3502 for covering features and/or sample vessels located therein. In some embodiments, the cover plate 3502 may comprise thermally insulating material. Optionally, cover plate 3502 may include a thermal control unit to assist in maintaining the interior of shipping container 3500 within a desired temperature range. Optionally, some embodiments may configure the cover plate 3502 as a thermally conductive material that may help maintain the interior of the shipping container 3500 within a desired temperature range through heat transfer from an external thermal control source. By way of non-limiting example, the thermal control source may be a cooling source, a heating source, a thermoelectric heat exchanger, or other thermal control device. It should also be understood that similar thermal control sources, such as, but not limited to, PCM or active cooling devices, may also be included in the vacant space 3514 below the layer 3516.

It should be appreciated that the feature 3512 for holding the retainers 3310, 3410 or other shaped retainers for vessels may be located in a separate part from the shipping container, or it may be integrally formed within the shipping container. Alternatively, feature 3512 may be part of a tray, such as trays 3302 and 3402 shown in Figures 41 and 42. Such trays may be fixed or removable from the shipping container 3500. A retention mechanism 3520 can also be incorporated into the pallet to allow it to remain in place during transport.

Sample Collection and Shipping

In embodiments, provided herein are systems and methods for the collection or transport of small volumes of bodily fluid samples.

In embodiments, sample vessels containing small volumes of bodily fluid samples can be transported. The samples and sample vessels can have any of the corresponding characteristics described elsewhere herein. In embodiments, the sample vessel may contain less than or equal to 5ml, 3ml, 4ml, 2ml, 1.5ml, 1ml, 750l, 500l, 400l, 300l, 200l, 150l, 100l, 75l, 50l, 40l, 30l, 20l, 10l or 5l of body fluid sample. In embodiments, the sample vessel may have less than or equal to 5ml, 3ml, 4ml, 2ml, 1.5ml, 1ml, 750l, 500l, 400l, 300l, 200l, 150l, 100l, 75l, 50l, 40l, 30l, 20l, Internal volume of 10l or 5l. In embodiments, the sample vessel may have less than or equal to 5ml, 4ml, 3ml, 2ml, 1.5ml, 1ml, 750l, 500l, 400l, 300l, 200l, 150l, 100l, 75l, 50l, 40l, 30l, 20l, 10l or 5l internal volume and may contain at least 10%, 20%, 30%, 40%, 50%, 60%, 70%, 80%, 90%, 95%, 98%, 99% of the vessel filled or 100% of the internal volume of the body fluid sample. In embodiments, the sample vessel can be sealed, for example, with a cap, cover, or membrane. Any of the vessel interior dimensions or sample dimensions described herein may apply to the interior dimensions of a sealed sample vessel, or the dimensions of the sample contained therein, respectively. In embodiments, the sealed sample vessel may have less than or equal to 5ml, 4ml, 3ml, 2ml, 1.5ml, 1ml, 750l, 500l, 400l, 300l, 200l, 150l, 100l, 75l, 50l, 40l, 30l, 20l , 10l or 5l of internal volume and it may contain at least 10%, 20%, 30%, 40%, 50%, 60%, 70%, 80%, 90%, 95%, 98% of the vessel filled , 99% or 100% of the internal volume of the body fluid sample such that less than or equal to 2ml, 1.5ml, 1ml, 750l, 500l, 400l, 300l, 200l, 150l, 100l, 75l, 50l, 40l, 30l, 20l, 10l, 5l, 4l, 3l, 2l or 1l of air. Thus, for example, a sealed sample vessel may have an interior volume of less than or equal to 300 1, and it may contain a bodily fluid sample that fills at least 90% of the interior volume of the vessel, such that there is less than or equal to the interior volume of the sealed vessel Equal to 30ul of air. In another example, a sealed sample vessel may have an interior volume of less than or equal to 500 liters, and it may contain a bodily fluid sample that fills at least 80% of the interior volume of the vessel, such that there is less than or Equal to 100 ul of air. In another example, a sealed sample vessel may have an interior volume of less than or equal to 150 l, and others may contain a bodily fluid sample that fills at least 98% of the interior volume of the vessel, such that there is less than or equal to 3l of air.

In embodiments, the sample vessel containing the sample may also contain an anticoagulant. The anticoagulant can be dissolved in the sample or otherwise present in the vessel (e.g., dried on one or more interior surfaces of the vessel, or in solid form on the bottom of the vessel). The sample vessel containing the sample may have a "total anticoagulant content", wherein the total anticoagulant content is the total amount of anticoagulant present in the interior volume of the vessel and includes anticoagulant dissolved in the sample ( if any), and the anticoagulant (if any) in the vessel that was not dissolved in the sample. In embodiments, a sample vessel containing a sample may contain no more than 1 ml of sample and have a total anticoagulant content of no more than 3 mg EDTA, may contain no more than 750 1 of sample and have a total anticoagulant content of no more than 2.3 mg EDTA , may contain no more than 500 l of sample and have a total anticoagulant content of no more than 1.5 mg EDTA, may contain no more than 400 l of sample and have a total anticoagulant content of no more than 1.2 mg EDTA, may contain no more than 300 l of sample and have a total anticoagulant content of not more than 0.9mg EDTA, may contain a sample of not more than 200l and have a total anticoagulant content of not more than 0.6mg EDTA, may contain a sample of not more than 150l and have a sample of not more than 0.45mg EDTA Total anticoagulant content, may contain no more than 100l of sample and have a total anticoagulant content of no more than 0.3mg EDTA, may contain no more than 75l of sample and have a total anticoagulant content of no more than 0.23mg EDTA, may contain No more than 50l of sample and have a total anticoagulant content of no more than 0.15mg EDTA, may contain no more than 40l of sample and have a total anticoagulant content of no more than 0.12mg EDTA, may contain no more than 30l of sample and have no more than Total anticoagulant content of 0.09mg EDTA, may contain no more than 20l of sample and have a total anticoagulant content of no more than 0.06 mg EDTA, may contain no more than 10l of sample and have no more than 0.03mg EDTA of total anticoagulant content, or may contain no more than 5 liters of sample and have a total anticoagulant content of no more than 0.015 mg EDTA. In embodiments, a sample vessel containing a sample may contain no more than 1 ml of sample and have a total anticoagulant content of no more than 2 mg EDTA, may contain no more than 750 1 of sample and have a total anticoagulant content of no more than 1.5 mg EDTA , may contain no more than 500 l of sample and have a total anticoagulant content of no more than 1 mg EDTA, may contain no more than 400 l of sample and have a total anticoagulant content of no more than 0.8 mg EDTA, may contain no more than 300 l of sample and Has a total anticoagulant content of not more than 0.6mg EDTA, may contain a sample of not more than 200l and has a total anticoagulant content of not more than 0.4mg EDTA, may contain a sample of not more than 150l and has a total of not more than 0.3mg EDTA Anticoagulant content, may contain no more than 100 l of sample and have a total anticoagulant content of no more than 0.2 mg EDTA, may contain no more than 75 l of sample and have a total anticoagulant content of no more than 0.15 mg EDTA, may contain no more than 50l sample and have a total anticoagulant content of not more than 0.1 mg EDTA, may contain a sample of not more than 40l and have a total anticoagulant content of not more than 0.08 mg EDTA, may contain a sample of not more than 301 and have a total anticoagulant content of not more than 0.06 Total anticoagulant content of mg EDTA, may contain no more than 20l of sample and have a total anticoagulant content of no more than 0.04mg EDTA, may contain no more than 10l of sample and have a total anticoagulant content of no more than 0.02mg EDTA , or may contain no more than 5 liters of sample and have a total anticoagulant content of no more than 0.01 mg EDTA. In embodiments, a sample vessel containing a sample may contain no more than 1 ml of sample and have a total anticoagulant content of no more than 30 United States Pharmacopeia (USP) units heparin, may contain no more than 750 1 of sample and have no more than 23 USP units heparin of total anticoagulant content, may contain no more than 500 l of sample and have a total anticoagulant content of no more than 15 USP units heparin, may contain no more than 400 l of sample and have a total anticoagulant content of no more than 12 USP units heparin, may Contains no more than 300 l of sample and has a total anticoagulant content of no more than 9 USP units of heparin, may contain no more than 200 l of sample and has a total anticoagulant content of no more than 6 USP units of heparin, may contain no more than 150 l of sample and has a total anticoagulant content of no more than 6 USP units Total anticoagulant content of not more than 4.5USP units heparin, may contain not more than 100l of sample and have a total anticoagulant content of not more than 3 USP units of heparin, may contain not more than 75l of sample and have not more than 2.3 USP units of heparin total anticoagulant content, may contain no more than 50 liters of sample and have a total anticoagulant content of no more than 1.5 USP units heparin, may contain no more than 40 liters of sample and have a total anticoagulant content of no more than 1.2 USP units heparin, May contain no more than 30 l of sample and have a total anticoagulant content of no more than 0.9 USP units heparin, may contain no more than 20 l of sample and have a total anticoagulant content of no more than 0.6 USP units heparin, may contain no more than 10 l and have a total anticoagulant content of no more than 0.3 USP units of heparin, or may contain no more than 5 liters of sample and have a total anticoagulant content of no more than 0.15 USP units of heparin. In embodiments, a sample vessel containing a sample may contain no more than 1 ml of sample and have a total anticoagulant content of no more than 15 USP units of heparin, may contain no more than 750 liters of sample and have a total anticoagulant of no more than 11 USP units of heparin content, may contain no more than 500l of sample and have a total anticoagulant content of no more than 7.5USP units heparin, may contain no more than 400l of sample and have a total anticoagulant content of no more than 6USP units heparin, may contain no more than 300l sample and have a total anticoagulant content of no more than 4.5 USP units of heparin, may contain no more than 200 l of sample and have a total anticoagulant content of no more than 3 USP units of heparin, may contain no more than 150 l of sample and have no more than 2.3 Total anticoagulant content of USP units of heparin, may contain no more than 100 l of sample and have a total anticoagulant content of no more than 1.5 USP units of heparin, may contain no more than 75 l of sample and have no more than 1.2 USP units of heparin total anticoagulant content Coagulant content, may contain no more than 50 l of sample and have a total anticoagulant content of no more than 0.75 USP units heparin, may contain no more than 40 l of sample and have a total anticoagulant content of no more than 0.6 USP units heparin, may contain No more than 30l of sample and have a total anticoagulant content of no more than 0.45USP units of heparin, may contain no more than 20l of sample and have a total anticoagulant content of no more than 0.3USP units of heparin, may contain no more than 10l of sample and Have a total anticoagulant content of no more than 0.15 USP units of heparin, or may contain no more than 5 1 of the sample and have a total anticoagulant content of no more than 0.08 USP units of heparin.

In embodiments, two or more sample vessels containing samples from a single subject can be obtained or shipped. When two or more sample vessels containing samples from a single subject are obtained or transported, the two or more vessels may be stored in vessels with or without samples from other subjects or transportation. In embodiments, at least 2, 3, 4, 5, 6, 7, 8, 9, or 10 sample vessels containing a sample from a single subject can be obtained or shipped. In embodiments, no more than 2, 3, 4, 5, 6, 7, 8, 9, or 10 sample vessels containing samples from a single subject can be obtained or shipped. In embodiments, at least 2, 3, 4, 5, 6, 7, 8 or 9 sample vessels and no more than 3, 4, 5, 6, 7, 8, 9 or 10 sample vessels. In embodiments involving two or more sample vessels containing samples from the same subject, the samples in each sample vessel may be obtained from the subject at the same or different times. In some embodiments involving two or more sample vessels containing samples from the same subject, the sample in each sample vessel may be from the same location or source site on the subject. For example, two sample vessels can be obtained that contain whole blood from the same subject, wherein both sample vessels contain whole blood from the same finger stick site. In other embodiments involving two or more sample vessels containing samples from the same subject, the sample in each sample vessel is from a different location/origin on the subject. For example, two sample vessels may be obtained that contain whole blood from the same subject, with one sample vessel containing whole blood from a first finger stick site (eg, on a first finger/toe) and a second sample vessel Whole blood from the second finger stick site (eg, on the second finger/toe) is included. In embodiments involving two or more sample vessels containing samples from a single subject, the two or more sample vessels may contain different types of anticoagulants or other blood additives. For example, a first sample vessel may contain whole blood with EDTA and a second sample vessel may contain whole blood with heparin, wherein the samples are from the same subject. In another example, the first sample vessel and the second sample vessel may contain whole blood with EDTA and the third sample vessel may contain whole blood with heparin, wherein the samples are from the same subject. In another example, a first sample vessel may contain whole blood with EDTA, a second sample vessel may contain whole blood with heparin, and a third sample vessel may contain whole blood with sodium citrate, wherein the samples are from the same subject. In embodiments involving two or more sample vessels containing samples from a single subject, the two or more sample vessels may contain different types of samples from the subject. For example, a first sample vessel may contain whole blood and a second sample vessel may contain plasma from the same subject. In another example, the first sample vessel may contain whole blood and the second sample vessel may contain urine from the same subject. In another example, the first sample vessel and the second sample vessel may contain whole blood, while the third sample vessel may contain saliva from the same subject.

In the systems and methods provided herein, a total volume of bodily fluid samples can be obtained from a subject. The total volume of the body fluid sample can be transferred into a single sample vessel, or into two or more sample vessels. For example, a body fluid sample with a total volume of 500 microliters can be obtained from the subject and transferred into a single sample vessel, wherein the single sample vessel has a maximum internal volume of 600 microliters. In another example, a body fluid sample with a total volume of 500 microliters can be obtained from the subject and transferred into two sample vessels, where each sample vessel has a maximum internal volume of 300 microliters. In another example, a body fluid sample with a total volume of 500 microliters may be obtained from the subject and transferred into two sample vessels, one with a maximum internal volume of 400 microliters and one sample vessel with a maximum internal volume of 400 microliters. Has a maximum internal volume of 100 microliters. In the systems and methods provided herein, less than or equal to 5ml, 4ml, 3ml, 2ml, 1.5ml, 1ml, 750l, 500l, 400l, 300l, 200l, 150l, 100l, 75l, 50l, Body fluid samples in total volume of 40l, 30l, 20l, 10l, 5l or 1l. The total volume of bodily fluid sample from the subject can be distributed among 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 or more sample vessels, as described elsewhere herein. When the total volume of the bodily fluid sample from the subject is distributed between two or more sample vessels, portions of the total volume of the bodily fluid sample in some or all of the different sample vessels may contain different anticoagulants or other additives. For example, a total volume of 500 microliters of bodily fluid sample can be obtained from a subject and transferred into two sample vessels, one containing 250 microliters of bodily fluid sample mixed with EDTA and one containing A 250 microliter sample of body fluid mixed with heparin. Generally, as used herein, a total volume of bodily fluid sample means a single type of bodily fluid sample—e.g., whole blood or urine or saliva, and the like.

In an embodiment, a sample vessel containing whole blood may be centrifuged prior to its storage or shipment, such that the whole blood is separated into plasma and pelleted cells prior to shipment of the sample vessel. In other embodiments, the sample vessel containing whole blood is not centrifuged prior to its storage or shipping.

In some embodiments of the systems and methods provided herein, the bodily fluid sample may be dried after its collection and prior to its transport. In embodiments, the dried sample can be later reconstituted into a liquid form, such as during analysis or processing of the sample.

In embodiments of the systems and methods provided herein, the sample vessel can be transported from a first location to a second location. The first location can be a location where a sample is collected from a subject, and the second location can be a location where one or more steps are performed in order to process or analyze the sample. Samples and sample vessels can have any of the corresponding characteristics described elsewhere herein. For example, the sample can be in a liquid, non-matrix, non-wicking form. Sample vessels can be shipped in shipping containers as described herein or in other structures. For example, in some alternative embodiments, the sample vessel may be transported in a bag, pouch, envelope, box, capsule, or other structure. In embodiments, the first location and the second location may be within the same room, building, campus, or complex. In embodiments, the first location and the second location may be separated by at least 1 meter, 5 meters, 10 meters, 50 meters, 100 meters, 500 meters, 1 kilometer, 5 kilometers, 10 kilometers, 15 kilometers, 20 kilometers km, 30 km, 50 km, 100 km or 500 km. In embodiments, the first location and the second location may be separated by no more than 5 meters, 10 meters, 50 meters, 100 meters, 500 meters, 1 kilometer, 5 kilometers, 10 kilometers, 15 kilometers, 20 kilometers , 30 km, 50 km, 100 km, 500 km or 1000 km. In embodiments, the first location and the second location may be separated by at least 1 meter, 5 meters, 10 meters, 50 meters, 100 meters, 500 meters, 1 kilometer, 5 kilometers, 10 kilometers, 15 kilometers, 20 kilometers kilometer, 30 kilometers, 50 kilometers, 100 kilometers, or 500 kilometers and not more than 5 meters, 10 meters, 50 meters, 100 meters, 500 meters, 1 kilometer, 5 kilometers, 10 kilometers, 15 kilometers meters, 20 kilometers, 30 kilometers, 50 kilometers, 100 kilometers, 500 kilometers, or 1000 kilometers. In embodiments where the first location is the location where the sample is obtained from the subject, it may be at 48 hours, 36 hours, 24 hours, 12 hours, 8 hours, 6 hours, 4 hours, 3 hours after the sample is collected from the subject , 2 hours, 1 hour, 45 minutes, 30 minutes, 15 minutes, 10 minutes, 5 minutes, 1 minute, or 30 seconds to transport the sample vessel from the first location to the second location.

As used herein, a "sample receiving location" is a place where a transported sample can be received and where one or more steps can be performed on the sample. For example, a sample arriving at a sample receiving site may be processed, analyzed, or disposed of at the sample receiving site, for example, as part of a detection or assay of the sample. Samples can be transported, for example, in any vessel or device described herein. In embodiments, the sample receiving site may contain one or more sample processing devices that may be used to process or analyze the sample. The sample processing device may be, for example, as described in U.S. Patent Application Serial No. 13/244,947, filed September 26, 2011, or as described in any other document incorporated by reference elsewhere herein. During transport of the sample from the sample collection site to the sample receiving site, the sample may pass through any number of locations. In an embodiment, the first location may be a sample collection site and the second location may be a sample receiving site.

Referring to Figure 44, one embodiment of body fluid sample collection and transport will now be described. Figure 44 shows a body fluid sample B on a skin surface S of a subject. In the non-limiting example of Figure 44, the body fluid sample B may be collected by one of a variety of devices. By way of non-limiting example, collection device 3530 may be, but is not limited to, those described in US Patent Application Serial No. 61/697,797, filed September 6, 2012, which is incorporated by reference in its entirety. This is for all purposes. In this embodiment, bodily fluid sample B is collected by one or more capillary channels and then directed into sample vessel 3540. By way of non-limiting example, at least one of the sample vessels 3540 may have an interior initially under partial vacuum for drawing a bodily fluid sample into the sample vessel 3540. Some embodiments may simultaneously draw sample from the sample collection device into the sample vessel 3540 from the same or different collection channels in the sample collection device. Alternatively, some embodiments may simultaneously draw the sample into the sample vessel.

In this embodiment, the sample vessel 3540 in its holder 3542 (or alternatively, removed from its holder 3542) is loaded into the shipping container 3500 after the bodily fluid sample is within the sample vessel 3540. In this embodiment, there may be one or more slots sized for the sample vessel holder 3542, or slots for the sample vessels in the shipping container 3500. By way of non-limiting example, the wells may hold sample vessels in an array configuration and be oriented vertically or in some other predetermined orientation. It will be appreciated that some embodiments of the sample vessels 3540 are configured such that they hold different amounts of sample in each vessel. By way of non-limiting example, this can be controlled based on the amount of vacuum force in each sample vessel, the amount of sample collected in one or more sample collection channels of the collection device, and/or other factors. Optionally, there may also be different pretreatments in the sample vessel, such as, but not limited to, different anticoagulants and the like.

As seen in Figure 44, the sample vessel 3540 is collecting a sample at a first location, such as, but not limited to, a sample collection site. By way of non-limiting example, the bodily fluid sample is then transported in shipping container 3500 to a second location, such as, but not limited to, a receiving site, such as, but not limited to, an analysis site. The shipping method can be by courier, postal courier or other shipping technology. In many embodiments, shipping can be accomplished by having a further container in which the shipping container is housed. In one embodiment, the sample collection site may be a point of care. Optionally, the sample collection site is a service point. Optionally, the sample collection site is remote from the sample analysis site.

Although the present embodiment of Figure 44 illustrates the collection of bodily fluid samples from the surface of the subject, other alternative embodiments may use collection techniques for collecting samples from other areas of the subject, such as by venipuncture, to fill one or more sample vessels 3540. Such other collection techniques are not excluded from being used as an alternative to or in combination with surface collection. Surface collection can be on the outer surface of the subject. Alternatively, some embodiments may be collected from accessible surfaces in the subject. The presence of bodily fluid sample B on these surfaces can occur naturally or through wound creation or other techniques that make the bodily fluid surface accessible.

Referring now to Figure 45, yet another embodiment is described herein in which a bodily fluid sample can be collected from a subject as opposed to collecting a sample pooled on the subject's surface. This embodiment of Figure 45 shows a collection device 3550 having a hypodermic needle 3552 configured to collect a sample of bodily fluid, such as, but not limited to, venous blood. In one embodiment, a bodily fluid sample can fill the chamber 3554 in the device 3550, at which point one or more sample vessels 3540 can be engaged to draw the sample into the corresponding one or more vessels. Optionally, some embodiments may not have the chamber 3554, but instead have one or more channels, one or more passages, or one or more tubes for directing the sample from the needle 3552 to the one or more sample vessels 3540. There is very little free space outside. For bodily fluid samples such as blood, the pressure from within the blood vessel is such that the blood sample can fill chamber 554 without much (if any) assistance from the collection device. Such embodiments may optionally include one or more vent holes, such as but not limited to ports, to allow air to escape when the channels in the collection device are filled with sample.

At least some or all embodiments may have fill indicators, such as, but not limited to, viewing windows or openings that show when a sample is present within the collection device and thereby indicate that it is acceptable to engage one or more sample vessels 3540. Optionally, embodiments without a fill indicator are not excluded. After the desired fill level is reached, one or more filled sample vessels 3540 can be disconnected from the sample collection device. Optionally, one or more additional sample vessels 3540 can be coupled to the sample collection device 3550 (or 530) to collect additional quantities of bodily fluid samples.

FIG. 46 shows a further embodiment of a sample collection device 3570. The embodiment described herein has a tissue penetrating portion 3572, such as, but not limited to, a hypodermic needle with a gripping portion 3574. The grip portion 3574 may facilitate positioning of the tissue penetrating portion 3572 for more accurate patient access to a desired depth and location. In this embodiment, one or more sample collection vessels 3540 are located in a carrier 3576 that is not in direct physical contact with the tissue penetrating portion 3572. Fluid connection passages 3578, such as, but not limited to, flexible tubing, may be used to connect the tissue penetrating portion 3572 to one or more sample collection vessels 3540. Some embodiments have one or more sample vessels 3540 configured to be slidable to be in fluid communication with the tissue penetrating portion 3572 only under user control. At least some or all embodiments may have fill indicators, such as but not limited to viewing windows or openings, that show when a sample is present within the collection device and thereby indicate that it is acceptable to engage one or more sample vessels 3540. Optionally, embodiments without a fill indicator are not excluded. Some embodiments may optionally include one or more vent holes, such as but not limited to ports, to allow air to escape when the channels in the collection device are filled with sample. In most embodiments, one or more filled sample vessels 3540 can be disconnected from the sample collection device after the desired fill level is reached. Optionally, one or more additional sample vessels 3540 can be coupled to the sample collection device 3570 to collect additional quantities of bodily fluid samples.

Sample processing

Referring now to Figure 47, there is shown a system view of the shipping container 3500 having its contents unloaded by unloading the assembly 3600 after reaching the destination location. In one embodiment, after positioning the cover plate 3502 in the open position, the sample vessel located therein can be removed from the vessel 3500. By way of non-limiting example, the removal may be by removing the entire tray of sample vessels, removing holders of multiple sample vessels from the tray, and/or by removing the sample vessels individually. Some embodiments may use a robotic control structure 3602 that can move vertically as indicated by arrows 3604 and/or horizontally along a traverse bridge 3608 as indicated by arrows 3606 to remove transport from transport. Container 3500 removes the sample vessel. The position of the structure 3602 for manipulating the sample vessel can be controlled using the programmable processor 3610. In one embodiment, the structure 3602 includes a magnet for engaging a retention mechanism to remove the tray from the structure 3602. Other implementations using robotic arms and/or other types of programmable manipulators are not excluded and may be configured for use herein.

In embodiments, the sample can be removed from the sample vessel when the sample vessel containing the sample arrives at a location for processing or analysis of the sample. The sample vessel can be treated (e.g., shaken, spun, mixed, or centrifuged) prior to removing the sample from the sample vessel. The sample may be removed from the sample vessel by any suitable mechanism, such as suction (eg, by a fluid handling system or pipette), pouring, or mechanical force (eg, by reducing the size of the interior area of the sample vessel). Press the sample out of the vessel). In embodiments, when the sample is removed from the sample vessel, little or no sample remains in the vessel (e.g., as mechanical/transfer losses). For example, less than or equal to 501, 401, 301, 201, 151, 101, 51, 41, 31, 21, 11, or 01 of sample may remain in the sample vessel after the sample is removed from the vessel.

By way of non-limiting example, the sample in the sample vessel can then be processed using a system such as that described in US Patent Application Serial No. 13/244,947, filed September 26, 2011, which is incorporated by reference in its entirety used here for all purposes. The analysis system may be configured in a CLIA-compliant manner as described in U.S. Patent Application Serial No. 13/244,946, filed September 26, 2011, which is hereby incorporated by reference in its entirety for all purposes. In embodiments, a sample transported in accordance with the systems and methods provided herein may be divided into two or more smaller portions upon arrival at a location for processing or analysis, and various assays may be performed on the sample. For example, in embodiments, at least 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 20, 30, 40, or 50 samples transported according to the systems and methods provided herein can be performed Determination. The assays can include different types of assays (e.g., for assaying proteins, nucleic acids, or cells) and use one or more detection methods (e.g., cell counting, luminescence, or spectrophotometer-based methods). In an embodiment, two or more sample vessels containing a sample from a single subject can be transported, wherein the two or more sample vessels contain at least two different anticoagulants mixed with the sample (For example, one sample vessel contains EDTA-sample and one sample vessel contains heparin-sample). The sample from the EDTA-sample vessel can then be used for one or more assays that are heparin-sensitive or EDTA-insensitive. Similarly, samples from heparin-sample vessels can then be used in one or more assays that are EDTA-sensitive or heparin-insensitive. In embodiments, samples transported in accordance with the systems and methods provided herein may be divided into two or more portions upon arrival at the destination, and separated at 1, 2, 3, 4, 5, 6, 7, 8, 9 , 10 or more different samples were analyzed on the analyzer.

Referring now to Figures 49-51, it should be understood that at least any two of the assays on the list (Figures 49-51) can be performed using a sample from a subject prepared or transported according to the systems or methods provided herein. kind of detection. For example, at least two assays on the list can be performed using a body fluid sample from a subject, wherein the total volume of the body fluid sample used to conduct the assay does not exceed 300 microliters, and the total volume of the body fluid sample from the subject is at least 300 microliters. Liquid forms are shipped in sample vessels with an internal volume of 400 microliters or less. In another example, at least two assays on the list can be performed using a body fluid sample from a subject, wherein the total volume of the body fluid sample used to conduct the assay does not exceed 300 microliters, and the total volume from the subject The bodily fluid sample is transported in liquid form in a first sample vessel and a second sample vessel, each vessel having an internal volume of 200 microliters or less, the first sample vessel containing the bodily fluid sample mixed with the first anticoagulant And the second sample vessel contains the body fluid sample mixed with the second anticoagulant. In embodiments, at least 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13 on the list (FIGS. 49-51 ) can be performed using a body fluid sample from a subject , 14, 15, 20, 25, 30, 35, 40, 50, or 60 assays, the body fluid sample having no greater than or equal to 5ml, 4ml, 3ml, 2ml, 1.5ml, 1ml, 750l, 500l, 400l, 300l , 200l, 150l, 100l, 75l, 50l, 40l, 30l, 20l, 10l, 5l or 1l total volume. The total volume of bodily fluid sample can be stored in a single sample vessel or transported from the collection site to the analysis or processing location, or it can be , 14, 15, 20, 25 or more sample vessels. When the ensemble of body fluid samples from a single subject is integrated into two or more sample vessels, the sample portions in some or each sample vessel may contain different anticoagulants or other additives. In an example, a sample of bodily fluid from a subject in a total volume of no more than 300 microliters may be used to perform two or more assays, wherein at least a portion of the sample of no more than 300 microliters is admixed with the first anticoagulant, A second portion of the sample, up to 300 microliters, is mixed with a second anticoagulant different from the first anticoagulant. Optionally, each portion of the sample up to 300 microliters is in its own sample vessel. Alternatively, two or more assays can be performed with no more than 300 microliters of sample all shipped in a single vessel and containing a single anticoagulant. Alternatively, at least any three assays on the list can be performed using blood from the subject in a total volume of no more than 300 microliters for all assays. Optionally, at least any five tests on the list can be performed using blood from the subject in a total volume of no more than 300 microliters for all tests. Optionally, at least any seven tests on the list can be performed using blood from the subject in a total volume of no more than 300 microliters for all tests. Optionally, at least any ten tests on the list can be performed using blood from the subject in a total volume of no more than 300 microliters for all tests. Optionally, at least any fifteen tests on the list can be performed using blood from the subject in a total volume of no more than 300 microliters for all tests. Optionally, at least any twenty tests on the list can be performed using blood from the subject in a total volume of no more than 300 microliters for all tests. For any of the above, in at least some embodiments, at least one portion has a first anticoagulant and a second portion has a second anticoagulant that is different from the first anticoagulant.

Referring now to Figure 52, yet another embodiment of a device for bodily fluid sample collection is shown. Figure 52 shows a subject's body fluid sample B being collected by collection device 3710. As seen in Figure 52, the collection device 3710 may include a collection portion 3712, such as, but not limited to, a capillary or other collection structure. The collection portion 3712 draws fluid therein and ultimately directs the fluid toward the lumen 3714 of the device 3710. After the collection portion 3712 has collected the desired amount, the entire device 3710 can be oriented as shown in FIG. 52 so that gravity can then draw the sample into the cavity 3714. After all of the sample B has been moved into the cavity 3714, the collection portion 3712 can be removed from the device 3710. In one embodiment, the cap and collection portion 3712 is removed and replaced with a closed cap 3718. In one non-limiting example, cap 3718 may be a cap without any openings thereon. Optionally, some embodiments may have a septum or other closable opening in the cap where the collection portion 3712 may be removed without having to replace the cap with a new cap of a different configuration.

Modular sample collection device

53A-53C, although embodiments herein generally describe a sample collection device as having an adapter portion 3750 for connecting a sample collection portion 3740 with a sample storage vessel 3760, it should be understood that the absence of such a configuration is not excluded implementation.

By way of the non-limiting example in Figure 53A, one or more adapter portions 3750 may be discrete components that are not initially in direct fluid communication with either the collection portion 3740 or the sample storage vessel 3760. Here, the collection portion 3740 may be connected to the vessel 3760 by means of relative movement (sequentially or simultaneously) between one or more of the collection portion, the adapter portion 3750, or the one or more vessels 3760 to create a Collection channels lead to fluid passages in the vessel through the one or more adapter channels.

By way of the non-limiting example in Figure 53B, some embodiments may not have a discrete, separate adapter portion 3750, as previously set forth herein. Here, the collection portion 3740 may be directly connected to the vessel 3760 by means of relative movement between one or both of these elements as indicated by arrow 3770. As seen in Figure 53B, there may be fluid flow features 3780 with relative motion between one or both of these elements as indicated by arrows 3782. In one non-limiting example, the fluid flow feature 3780 may be a cap that engages one end of the collection portion 3740 to facilitate fluid flow into the vessel 3760. Alternatively, the fluid flow feature 3780 may be a cap with a front surface shaped to engage the collection portion 3740. Alternatively, the fluid flow feature 3780 may be a plunger, rod, and/or other device to facilitate flow toward the sample storage vessel 3760. Optionally, the fluid flow feature 3780 is not fully engaged until the sample collection portion 3740 is ready to engage the vessel 3760. Optionally, some embodiments may be configured such that the flow from the collection portion 3740 to the sample storage vessel 3760 does not use the fluid flow feature 3780, but is instead based on a different dynamic, such as, but not limited to, gravity, vacuum suction, or in the collection The blowing force provided at the appropriate end of the portion 3740.

By way of the non-limiting example in Figure 53C, one or more embodiments may use the collection portion 3740 as a storage vessel. Once the desired fill level is achieved, some embodiments may simply cover both ends with caps 3790 and 3792. As seen in the diagram in Figure 53C, caps 3790 and 3792 can retain fluid therein even when portion 3740 is in a vertical orientation.

Variations and substitutions are possible for the embodiments described herein, and no single embodiment should be construed as encompassing the entire invention. For example, two or more capillaries may be present in the collection section 3740. Alternatively, they may each be formed as separate tubes or channels. Alternatively, some embodiments may have a common initial section but separate outlet ports, such as but not limited to a Y-shaped configuration. It should be understood that any of the embodiments herein can be modified to include the features set forth in the description with respect to Figures 53A-53C.

Referring now to Figure 54, after the sample vessel 3800 reaches the desired processing destination, the sample in the vessel 3800 may be properly prepared. In one embodiment, vessel 3800 is similar to vessel 3710. As seen in Figure 54, the sample can be processed to aliquot into a processing device, such as, but not limited to, an inlet on cartridge 3802 and another inlet on another cartridge 3804. In one embodiment, both cartridges 3802 are microfluidic disks that process samples for blood chemistry assays such as, but not limited to: Comprehensive Metabolic Panel (ALB, ALP, ALT) , AST, BUN, Ca, Cl-, CRE, GLU, K+, Na+, TBIL, tCO2, TP); Basic Metabolic Panel (BUN, Ca, CRE, eGFR, GLU, Cl-, K+, Na+, tCO2); Lipid Panel (LipidPanel) (CHOL, HDL, CHOL/HDL, LDL, TRIG, VLDL, nHDLc); Lipid Panel Plus (tCHOL, HDL, CHOL/HDL ratio, LDL, TRIG) , VLDL, GLU, ALT, AST, nHDLc); LiverPanel Plus (ALB, ALP, ALT, AST, AMY, TBIL, TP, GGT); Electrolyte Panel (Cl-, K+, Na+, tCO2); General Chemistry (ALB, ALP, ALT, AMY, AST, BUN, Ca, CRE, eGFR, GGT, GLU, TBIL, TP, UA); General Chemistry 6 (General Chemistry 6) ( ALT, AST, CRE, eGFR, GLU, BUN, GGT); Renal Function Panel (ALB, BUN, Ca, CRE, eGFR, GLU, Cl-, K+, Na+, tCO2PHOS); Metlyte (Cl- , K+, Na+, tCO2, BUN, CK, CRE, eGFR, GLU); Kidney Function (BUN, CRE, eGFR); Hepatic Function Panel (ALB, ALP, ALT, AST, DBIL) , TBIL, TP); Basic Metabolic Panel (BUN, Ca, CRE, eGFR, GLU, Cl-, K+, Na+, tCO2, Mg, LDH); MetLyte Plus CRP (Cl-, K+, Na+) , tCO2, BUN, CK, CRE, eGFR, GLU, CRP); BioChemistry Panel Plus (ALB, ALP, ALT, AMY, AST, BUN, Ca, CRE, eGFR, CRP, GGT, GLU, TP, UA); MetLac (ALB, BUN, Ca, Cl-, CRE, GLU, K+, LAC, Mg, Na+, Phos, tCO2). It should be understood that other fluid handling techniques that may be developed in the future may also be suitable for use in at least one embodiment herein. In some embodiments, samples can be delivered to one or more general chemical microfluidics/centrifugation cartridges 3802 (and/or or 3804). At least one or more other cartridges, such as, but not limited to, open fluid mobility cartridges as described in the applications incorporated herein by reference, may also be used to improve the types of detection available. Although at least two destination cartridges are shown, it should be understood that embodiments with more than two cartridges (as shown in additional cartridges shown in phantom) are not excluded. Fluid transport can be via pipettes, via fluidic conduits, microfluidics, or via other fluid handling technologies that may be developed in the future.

Referring now to Figure 55A, it will be appreciated that some embodiments may use a sample processing system having one or more pipettes to draw samples from vessel 3800 in a tubeless fashion. Although one or more pipettes are described in this embodiment, it should be understood that other fluid handling techniques that may be developed in the future may also be suitable for use in at least one embodiment herein. Figure 55A shows an automated system that can be used to aliquot a sample. It should also be understood that in some embodiments, before, during, or after aliquoting, there may be sample dilution in order to increase the liquid volume of the sample. This can be beneficial for various purposes. Figure 55A also shows that in some embodiments, samples can be delivered to one or more general chemical microfluidics/centrifugation cartridges 3802 (and/or 3804). At least one or more other cartridges, such as, but not limited to, open fluid mobile cartridges as described in the applications incorporated herein by reference, may also be used to improve the types of detection available. Although at least two destination cartridges are shown, it should be understood that embodiments with more than two cartridges (as shown in additional cartridges shown in phantom) are not excluded. Fluid transport can be via pipettes, via fluidic conduits, microfluidics, or via other fluid handling technologies that may be developed in the future. Some embodiments may use the same technique to move the sample to the cartridge or one or more other destinations, or alternatively, some embodiments may use a combination of one or more techniques to move the sample. By way of example and not limitation, detection may involve the use of other detection techniques, such as, but not limited to, ELISA, nucleic acid amplification, microscopy, spectrophotometry, electrochemistry, and/or other detection techniques, to expand the use of cartridges Types of analysis performed by cassette 3806 other than general chemical detection. Optionally, it should be understood that more than one cartridge 3802 and/or individual unit cartridges 3806 may be used herein with the system for dispensing from vessel 3800.

Referring now to Figure 55B, a further embodiment is shown in which a vessel 3800 is shown with a sample fluid therein. In one example, the sample fluid therein may be "clean" or undiluted. Optionally, some embodiments may be configured such that the sample may be pretreated at the collection site and/or the receiving site to dilute the sample and/or provide certain chemical materials to the sample. As seen in Figure 55B, the fluid handling system can use pipette 3602 to aliquot the sample from vessel 3800 into one or more other vessels 3810, 3812 and/or 3814. By way of non-limiting example, these vessels 3810, 3812 or 3814 may be the same vessels as vessel 3800. Alternatively, they can be different types of vessels. Based on the barcode or other information about the sample, the processor is programmed to determine at least one desired sample dilution for the sample and at least one desired number of aliquots. In this non-limiting example, the aliquots are each transported to one sample processing unit 3820, 3822, and 3824. The processing units may all be the same type of processing units, each processing unit may be a different type from each other, or some processing units may be the same and some may be different. In at least one non-limiting example, a sample processing unit can be a single sample processor or a batch processor that can process multiple samples simultaneously.

Figure 55C shows a further embodiment in which a sample is collected at a collection site and then transported to a second site while the sample remains in liquid form. Figure 55C shows multiple vessels with samples that can be collected from a single wound on a subject. This allows the subject to provide multiple samples that can be treated with different types of chemicals in each vessel. Figure 55C shows a courier that can deliver a shipping container that can contain a sample from only one subject or multiple samples from multiple subjects to a receiving location. Although a human courier is shown, it should be understood that robotic transport, drones, or other transport technologies, systems or devices that may be developed in the future (including but not limited to transport of one or more "virtual" versions of samples) are not excluded. ). In this non-limiting example, the receiving site may load one or more vessels 1504 from a shipping container into a cartridge with independently movable reagent units and/or assay units. The cartridge can then be loaded into one or more processing modules 701-707. These units can be the same module. Optionally, at least one of the modules is different from the other modules. Similar to FIG. 55B, some embodiments can include a processor 3830 that can coordinate the processing of the vessel 1504 containing the sample and/or the pre-diluted sample, or one or more other vessels, prior to loading the vessel 1504 into the cartridge. 1504 Dilution and/or aliquoting of the sample (based on vessel ID or other associated information). In at least one embodiment herein, each module can receive at least one cartridge and at least one sample vessel. Optionally, more than one sample vessel may be placed in each cartridge. Alternatively, the sample vessels may contain different types of samples, such that the cartridge may have more than one type of sample loaded into it. Optionally, some embodiments may have a module with at least one receiving area for the cartridge and at least one receiving area for the sample.

Optionally, some embodiments may have only one location for receiving a cartridge, which in turn also contains at least one sample. In this way, the risk of the user having to load separate items into the module is reduced. Once loaded, at least one embodiment herein is configured such that once the sample is inserted into the module, there is no further user manipulation of the sample. This non-limiting example can be used to minimize errors associated with human factors once a sample is being processed in the module.

It should also be understood that some embodiments may use centrifugal or other forces to process multiple samples simultaneously to reduce the samples to sedimentation levels within the sample vessel. In one non-limiting example, this can be accomplished by means of a tray centrifuge, such as, but not limited to, a 384-well plate centrifuge.

Figure 55C shows a system 700 having a plurality of modules 701-706 and a cytometry station 707 in accordance with an embodiment of the present invention. The plurality of modules includes a first module 701, a second module 702, a third module 703, a fourth module 704, a fifth module 705, and a sixth module 706.

A cytometry station 707 is operably coupled to each of the plurality of modules 701-706 through a sample processing system 708. As described herein, the sample processing system 708 may include a pipette, such as a positive displacement, venting, or aspiration pipette.

As described above and in other embodiments of the present invention, cytometry station 707 includes a cytometer for performing cell counts on samples. Cell counting station 707 may perform cell counting on a sample while one or more of modules 701-706 perform other preparation and/or assay procedures on another sample. In some cases, cell counting station 707 performs a cell count on the sample after the sample has undergone sample preparation within one or more of modules 701-706.

System 700 includes a support structure 709 having a plurality of stations (or mounting stations). The plurality of stations are used to dock the modules 701 - 706 to the support structure 709 . As shown, the support structure 709 is a rack.

Each module is secured to the rack 709 by means of attachment members. In one embodiment, the attachment member is a hook that is fastened to the module or station. In such a case, the hook is configured to slide into the socket of the module or station. In another embodiment, the attachment member includes a fastener, such as a screw fastener. In another embodiment, the attachment member is formed from a magnetic material. In such a case, the module and station may include magnetic materials of opposite polarity to provide an attractive force to secure the module to the station. In another embodiment, the attachment member includes one or more rails or rails in the table. In such a case, the module includes one or more structures for cooperating with one or more rails or rails to secure the module to the rack 709. Alternatively, power may be provided by rails.

Examples of structures that may allow a module to mate with a rack may include one or more pins. In some cases, the modules receive power directly from the rack. In some cases, the module may be a power source that internally powers the device, such as a lithium-ion battery or a fuel cell powered battery. In the example, the modules are configured to mate with the rack by means of rails, and the power to the modules comes directly from the rails. In another example, the module mates with the rack by means of attachment members (rails, pins, hooks, fasteners), but provides power to the module wirelessly, such as inductively (i.e., inductively coupled). In some embodiments, the modules that mate with the rack do not necessarily require pins. For example, inductive electrical communication may be provided between the module and a rack or other support. In some cases, wireless communication may be used, such as by means of ZigBee communication or other communication protocols or protocols that may be developed in the future.

Each module is removable from rack 709 . In some cases, a module may be replaced with the same, similar or different module. In one embodiment, the module is removed from the rack by sliding the module out of the rack 709. In another embodiment, the module is removed from the rack 709 by twisting or rotating the module to disengage the module's attachment members from the rack 709. Removing the module from rack 709 may terminate any electrical connectivity between the module and rack 709 .

In one embodiment, the module is attached to the rack by sliding the module into the bay. In another embodiment, the module is attached to the rack by twisting or rotating the module so that the attachment members of the module engage the rack 709. Attaching the module to the rack 709 establishes an electrical connection between the module and the rack. The electrical connections may be used to provide power to or from the modules to racks or devices, and/or to provide a communication bus between the modules and one or more other modules or controllers of the system 700.

Can occupy or not occupy every position of the rack. As shown, all of the bays of rack 709 are occupied by modules. However, in some cases, one or more bays of rack 709 are not occupied by a module. In the example, the first module 701 has been removed from the rack. In such a case, the system 700 may operate without the removed module.

In some cases, bays may be configured to accommodate a subset of the types of modules that system 700 is configured to use. For example, a station can be configured to receive a module capable of running agglutination assays rather than cytometry assays. In such a case, the module may be "dedicated" to agglutination. Agglutination can be measured in a number of ways. One method is to measure time-dependent changes in sample turbidity. This can be accomplished by illuminating the sample with light and measuring the reflected light at 90 degrees with an optical sensor such as a photodiode or camera. Over time, the measured light will increase as more light is scattered by the sample. Measuring time-dependent changes in transmittance is another example. In the latter case, this can be achieved by illuminating the sample in the vessel and measuring the light passing through the sample with an optical sensor, such as a photodiode or camera. Over time, the measured light may decrease or increase as the sample agglutinates (e.g., depending on whether the agglutinated material remains in suspension or settles out of suspension). In other cases, the bays may be configured to receive all types of modules for which the system 700 is configured to be used, ranging from inspection stations to supporting electrical systems.

Each module can be configured to function (or execute) independently of the other modules. In an example, the first module 701 is configured to execute independently of the second module 702, the third module 703, the fourth module 704, the fifth module 705 and the sixth module 706. In other cases, a module is configured to execute in conjunction with one or more other modules. In such a case, the module may support parallel processing of one or more samples. In an example, while the first module 701 prepares the sample, the second module 702 performs assays on the same or a different sample. This can support the minimization and elimination of downtime between modules.

The support structure (or rack) 709 may have a server type configuration. In some cases, the dimensions of the rack are standardized. In an example, the spacing between modules 701-706 is normalized to at least about 0.5 inches, or 1 inch, or 2 inches, or 3 inches, or 4 inches, or 5 inches, or 6 inches, or 7 inches, or 8 inches , or 9 inches, or 10 inches, or 11 inches, or multiples of 12 inches.

Rack 709 may support the weight of one or more of modules 701-706. Additionally, the frame 709 has a selected center of gravity such that the modules 701 (top) are mounted on the frame 709 without creating a moment arm that could cause the frame 709 to rotate or tip over. In some cases, the center of gravity of rack 709 is arranged between the vertical midpoint of the rack and the bottom of the rack, the vertical center being 50% from the bottom of rack 709 to the top of the rack. In one embodiment, the center of gravity of the rack 709 is arranged to be at least about 0.1%, or 1%, or 10%, or 20%, or 30%, or 40%, or 50%, or 60%, or 70%, or 80%, or 90%, or 100%.

A rack may have multiple bays (or mounting stations) configured to receive one or more modules. In the example, rack 709 has six mounting stations for allowing each of modules 701-706 to be mounted to the rack. In some cases, the bays are on the same side of the rack. In other cases, the bays are located on alternating sides of the rack.

In some embodiments, system 700 includes electrical connectivity components for electrically connecting modules 701-706 to each other. The electrical connectivity component may be a bus, such as a system bus. In some cases, the electrical connectivity components also enable modules 701-706 to communicate with each other and/or with a controller of system 700.

In some embodiments, system 700 includes a controller (not shown) for facilitating processing of the sample via one or more of modules 701-706. In one embodiment, the controller facilitates parallel processing of samples in modules 701-706. In an example, the controller directs the sample processing system 708 to provide the sample in the first module 701 and the second module 702 to run different assays on the sample simultaneously. In another example, the controller directs the sample processing system 708 to provide a sample within one of the modules 701-706, and also provides a sample (eg, a portion of a limited volume of the sample) to the cytometry station 707, such that the sample is The cell counts and one or more other sample preparation procedures and/or assays are performed in parallel. In this manner, the system minimizes, if not eliminates, downtime between modules 701-706 and cell counting station 707.

Each individual module of the plurality of modules may include a sample processing system for providing and removing samples to and from each of the processing modules and assay modules of the single module. In addition, each module may include various sample processing and/or assay modules, in addition to other components for facilitating the processing and/or assaying of samples with the modules. The sample processing system of each module may be separate from the sample processing system 708 of the system 700 . That is, sample processing system 708 transfers samples to and from modules 701-706, while the sample processing system of each module transfers samples to and from the various sample processing and/or assay modules included within each module.

In the example of FIG. 55C , the sixth module 706 includes a sample processing system 710 that includes an aspiration pipette 711 and a volumetric pipette 712 . The sixth module 706 includes a centrifuge 713 , a spectrophotometer 714 , a nucleic acid assay (such as a polymerase chain reaction (PCR) assay) station 715 and a PMT 716 . An example of a spectrophotometer 714 is shown in Figure 55C (see below). The sixth module 706 also includes a cartridge 717 for holding a plurality of tips for facilitating sample transfer to and from each processing or assay module of the sixth module.

In one embodiment, aspirating pipettes 711 include 1 or more, or 2 or more, or 3 or more, or 4 or more, or 5 or more , or 6 or more, or 7 or more, or 8 or more, or 9 or more, or 10 or more, or 15 or more, or 20 or more, or 30 or more, or 40 or more, or 50 or more heads. In an example, aspirating pipette 711 is an 8-tip pipette with eight heads. The aspirating pipette 711 may be as described in other embodiments of the present invention.

In some embodiments, positive displacement pipette 712 has less than or equal to about 20%, 15%, 12%, 10%, 9%, 8%, 7%, 6%, 5%, 4%, 3%, Coefficient of variation of 2%, 1%, 0.5%, 0.3% or 0.1% or less. The coefficient of variation is determined as σ/μ, where "σ" is the standard deviation and "μ" is the average value over the entire sample measurement.

In one embodiment, all modules are identical to each other. In another embodiment, at least some of the modules are different from each other. In an example, the first, second, third, fourth, fifth, and sixth modules 701-706 include volumetric and aspiration pipettes and various assays, such as nucleic acid assays and spectrophotometers. In another example, at least one of the modules 701-706 may have a different assay and/or sample preparation station than the other modules. In an example, the first module 701 includes an agglutination assay but not a nucleic acid amplification assay, and the second module 702 includes a nucleic acid assay but not an agglutination assay. Modules may not include any assays.

In the example illustrated in Figure 55C, modules 701-706 include the same assay and sample preparation (or manipulation) station. However, in other embodiments, each module includes any number and combination of assay and processing stations described herein.

Modules can be stacked vertically or horizontally relative to each other. Two modules are oriented perpendicular to each other if they are oriented along a plane parallel, substantially parallel, or nearly parallel to the gravitational acceleration vector. Two modules are oriented horizontally with respect to each other if they are oriented along a plane orthogonal, substantially orthogonal, or nearly orthogonal to the gravitational acceleration vector.

In one embodiment, the modules are stacked vertically, i.e., one module is on top of the other. In the example illustrated in Figure 55C, the rack 709 is oriented such that the modules 701-706 are mounted perpendicularly with respect to each other. In other cases, however, the modules are arranged horizontally with respect to each other. In such a case, the rack 709 can be oriented such that the modules 701-706 can sit horizontally side by side with each other.

In yet another embodiment of system 730, the system is shown having a plurality of modules 701-704. This embodiment shows a horizontal configuration in which modules 701 to 704 are mounted to a support structure 732 on which transport device 734 is movable along the X-axis, Y-axis and/or optionally along the Z-axis to Elements such as, but not limited to, sample vessels, tips, tubes, etc. are moved within and/or between modules. By way of non-limiting example, modules 701-704 are oriented horizontally with respect to each other if they are oriented along a plane that is normal, substantially normal, or nearly normal to the gravitational acceleration vector.

It should be understood that, as with the embodiment of Figure 55C, modules 701-704 may all be identical modules to each other. In another embodiment, at least some of the modules are different from each other. In an example, the first, second, third and/or fourth modules 701-704 may be replaced by one or more other modules, which may occupy the position of the replaced module. Other modules may optionally provide different functions, such as, but not limited to, replacing one of modules 701-704 with one or more cytometry modules 707, communication modules, storage modules, sample preparation modules, slide preparation modules, tissue preparation modules etc. For example, one of the modules 701-704 may be replaced with one or more modules that provide a different hardware configuration, such as, but not limited to, providing a thermally controlled storage chamber for incubation, storage between assays, and/or after assays storage. Optionally, modules that replace one or more of modules 701-704 may provide non-measurement related functionality, such as, but not limited to, additional telecommunications equipment for system 730, additional imaging or user interface equipment, or additional power sources, such as But not limited to batteries, fuel cells, etc. Optionally, modules that replace one or more of modules 701-704 may provide storage for additional disposables and/or reagents or fluids. It should be understood that while some embodiments show only four modules mounted on the support structure, other embodiments having fewer or more modules are not excluded from this horizontal mounting configuration. It should also be understood that the described configuration may also operate where not every bay or slot is occupied by a module, especially in any scenario where one or more types of modules draw more power than the others run. In such a configuration, power that should be directed to empty bays can be used by modules that may draw more power than other modules.

It should be understood that, as with the embodiment of Figure 55C, modules 701-706 may all be identical modules to each other. In another embodiment, at least some of the modules are different from each other. In an example, the first, second, third and/or fourth modules 701-706 may be replaced by one or more other modules, which may occupy the position of the replaced module. Other modules may optionally provide different functions, such as, but not limited to, replacing one of modules 701-706 with one or more cytometry modules 707, communication modules, storage modules, sample preparation modules, slide preparation modules, tissue preparation modules etc.

It should be understood that while some embodiments show only six modules mounted on the support structure, other embodiments having fewer or more modules are not excluded from this horizontal and vertical mounting configuration. It should also be understood that the described configuration may also operate where not every bay or slot is occupied by a module, especially in any scenario where one or more types of modules draw more power than the others run. In such a configuration, power that should be directed to an empty bay can be used by modules that may draw more power than other modules.

Some embodiments may provide a system with multiple modules 701 , 702 , 703 , 704 , 706 and 707 . Such embodiments may have additional modules that may include one or more modules that provide different hardware configurations, such as, but not limited to, thermally controlled storage chambers for incubation, storage between assays or storage after detection. Optionally, modules that replace one or more of modules 701-704 may provide non-measurement related functionality, such as, but not limited to, additional telecommunications equipment for the system, additional imaging or user interface equipment, or additional power sources, such as but not limited to Not limited to batteries, fuel cells, and the like. Optionally, modules that replace one or more of modules 701-707 may provide storage for additional disposables and/or reagents or fluids.

It should be understood that although Figure 55C shows seven modules mounted on the support structure, other embodiments having fewer or more modules are not excluded from this mounting configuration. It should also be understood that the configuration can also operate where not every bay or slot is occupied by a module, especially in any scenario where one or more types of modules draw more power than the other modules. In such a configuration, power that should be directed to an empty bay can be used by modules that may draw more power than other modules.

In some implementations, modules 701-706 communicate with each other and/or with a controller of system 700 via a communication bus ("bus"), which may include electronics for facilitating communication between the modules and/or controllers circuits and components. The communication bus includes subsystems that transfer data between the modules and/or controllers of system 700. The bus may enable the various components of system 700 to enter into communication with the central processing unit (CPU), memory (e.g., internal memory, system cache), and storage locations (e.g., hard disk) of system 700.

A communication bus may include parallel wires with multiple connections, or any physical arrangement that provides logical functionality as a parallel electrical bus. Communication buses can include parallel connections and bit-serial connections, and can be wired in multidrop (i.e., electrical parallel) or daisy-chain topologies, or connected through switching hubs. In one embodiment, the communication bus may be a first-generation bus, a second-generation bus, or a third-generation bus. The communication bus allows communication between each module and other modules and/or controllers. In some cases, the communication bus supports communication among multiple systems, such as among multiple systems similar to or the same as system 700.

System 700 may include one or more serial buses, parallel buses, or self-healing buses. The bus may include a master scheduler that controls data traffic, such as traffic to or from modules (e.g., modules 701-706), controllers, and/or other systems. Buses may include external buses, which connect external devices and systems to a main system board (e.g., a motherboard), and internal buses, which connect internal components of the system to the system board. Internal buses connect internal components to one or more central processing units (CPUs) and internal memory.

In some implementations, the communication bus may be a wireless bus. The communication bus can be Firewire (IEEE 1394), USB (1.0, 2.0, 3.0 or others), Thunderbolt or other protocols (existing or future developed protocols).

In some embodiments, system 700 includes one or more buses selected from the group consisting of: a media bus, a computer automatic measurement and control (CAMAC) bus, an industry standard architecture (ISA) Bus, USB bus, Firewire, Thunderbolt, Extended ISA (EISA) bus, Low pin count bus, MBus, Microchannel bus, Multibus, NuBus or IEEE 1196, OPTi local bus, Peripheral Component Interconnect (PCI) bus, Parallel Advanced Technology Attachment (ATA) bus, Q-bus, S-100 bus (or IEEE 696), SBus (or IEEE 1496), SS-50 bus, STE bus, STD bus (for STD-80 [8-bit] and STD32[16-/32-bit]), single bus, VESA local bus, VME bus, PC/104 bus, PC/104 Plus bus, PC/104 Express bus, PCI-104 bus, PCIe-104 bus, 1- Wire bus, HyperTransport bus, Inter-Integrated Circuit (I2C) bus, PCI Express (or PCIe) bus, Serial ATA (SATA) bus, Serial Peripheral Interface bus, UNI/O bus, SMBus, 2-wire or 3-wire Line interfaces, self-healing resilient interface buses, and variants and/or combinations thereof.

In some cases, system 700 includes a serial peripheral interface (SPI), which is an interface between one or more microprocessors of system 700 and peripheral or I/O components (e.g., modules 701-706). SPI can be used to combine 2 or more, or 3 or more, or 4 or more, or 5 or more, or 6 or more, or 7 or more , or 8 or more, or 9 or more, or 10 or more, or 50 or more, or 100 or more SPI-compatible I/O assemblies attached to a Microprocessor or microprocessors. In other cases, system 700 includes RS-485 or other standards.

In one embodiment, an SPI is provided with an SPI bridge having a parallel and/or series topology. Such a bridge allows one of many SPI components on the SPII/O bus to be selected without proliferating chip selects. This is accomplished by applying appropriate control signals as described below to allow daisy chaining of devices on the SPI bus or chip select for devices. However, it does not maintain parallel data paths, so there is no daisy-chain data to transfer between the SPI components and the microprocessor.

In some embodiments, an SPI bridge component is provided between the microprocessor and multiple SPI/O components connected in a parallel and/or serial (or series) topology. The SPI bridge component supports parallel SPI using MISO and MOSI lines, as well as serial (daisy-chained) local chip select connections (CSL/) to other slave devices. In one embodiment, the SPI bridge components provided herein address any issues associated with multi-chip selection for multi-slave devices. In another embodiment, the SPI bridge components provided herein support 4, 8, 16, 32, 64 or more single chip selects for 4 SPI enabled devices (CS1/-CS4/) . In another embodiment, the SPI bridge components provided herein support 4x cascading with external address line settings (ADR0-ADR1). In some cases, the SPI bridge components provided herein provide the ability to control up to 8, 16, 32, 64 or more general output bits for control or data. The SPI bridge components provided herein support the control of up to 8, 16, 32, 64 or more general output bits for control or data in some cases, and can be used for devices on the master station Identification and/or diagnostic communication to the master.

One embodiment may use an SPI bridge scheme with a master bridge and a parallel series SPI slave bridge according to an embodiment of the present invention. The SPI bus is enhanced by adding local chip select (CSL/), module select (MOD_SEL), and select data input (DIN_SEL) to the SPI bridge, allowing the addition of a wide variety of system features including essential and non-essential system features Features such as cascading of multiple slave devices, virtual daisy chaining of device chip selects to keep module-to-module signal counts at acceptable levels, support for module identification and diagnostics, and compatibility with embedded SPI slaves Components communicate with non-SPI components on the module while maintaining compatibility. Figure 55C shows an example of an SPI bridge according to an embodiment of the present invention. The SPI bridge includes internal SPI control logic, a control register (8-bit as shown), and various input and output pins.

In a parallel series configuration each slave bridge is connected to a master (also referred to herein as an "SPI master" or "master bridge"). The MOSI pins of each slave bridge are connected to the MOSI pins of the master bridge, and the MOSI pins of the slave bridges are connected to each other. Similarly, the MISO pins of each slave bridge are connected to the MISO pins of the master bridge, and the MISO pins of the slave bridges are connected to each other.

Each slave bridge may be a module (e.g., one of modules 701-706 of Figure 55C) or a component within a module. In the example, the first slave bridge is the first module 701, the second slave bridge is the second module 702, and so on. In another example, the first slave bridge is a component of the module.

At least one non-limiting example may use a module component diagram with interconnected module pins and various components of master and slave bridges in accordance with embodiments of the present invention. According to embodiments of the present invention, the slave bridges may be connected to the master bridge. The MISO pin of each slave bridge is in electrical communication with the MOSI pin of the master bridge. The MOSI pin of each slave bridge is in electrical communication with the MISO pin of the master bridge. The DIN_SEL pin of the first slave bridge (left) is in electrical communication with the MOSI pin of the first slave bridge. The DOUT_SEL pin of the first slave bridge is in electrical communication with the DIN_SEL pin of the second slave bridge (right). An additional slave bridge can be connected as a second slave by bringing the DIN_SEL pin of each additional slave bridge into electrical communication with the DOUT_SEL pin of the previous slave bridge. In such a case, the slave bridges are connected in a parallel series configuration.

In some implementations, when the module select line (MOD_SEL) is asserted, a CLK pulse directed to a connected SPI bridge captures the state of the DIN_SEL bit shifted into the bridge. The number of DIN_SEL bits corresponds to the number of modules connected together on a parallel serial SPI link. In one example, if two modules are connected in a parallel series configuration (for example, RS486), the number of DIN_SELs is equal to 2.

In one embodiment, an SPI bridge that latches a "1" during a module selection sequence becomes a "selected module" that is set up to receive an 8-bit control word during a subsequent component selection sequence. Each SPI bridge can access up to 4 cascaded SPI slaves. Additionally, each SPI bridge can have an 8-bit GP receive port and an 8-bit GP transmit port. The "Component Select" sequence writes an 8-bit word to the "Selected Module" SPI Bridge Control Register to support subsequent transactions with a specific SPI device or to read and write data via the SPI Bridge GPIO port.

In one embodiment, component selection is performed by asserting the local chip select line (CSL/) and then clocking the first byte of the data word of the MOSI transfer into the control register. In some cases, the format of the control register is CS4 CS3 CS2 CS1 AD1 AD0R/W N. In another embodiment, the second byte is transmit or receive data. The loop completes when CSL/ is de-asserted.

In an SPI transaction, following the component selection sequence, a subsequent SPI slave data transaction begins. SPICS/ (which may be referred to as SS/) is routed to one of 4 possible bridge devices according to the true state of CS4, CS3, CS2 or CS1. Jumper bits AD0, AD1 are compared with AD0, AD1 in the control register, allowing up to 4 SPI bridges on the module.

One embodiment shows an apparatus according to an embodiment of the invention having a plurality of modules mounted on the SPI link of the communication bus of the apparatus. The figure shows 3 modules, namely module 1, module 2 and module 3. Each module includes one or more SPI bridges for bringing various components of the module into electrical connection with the SPI link, including a host controller (including one or more) in electrical communication with the SPI link. CPUs). Module 1 includes a plurality of SPI slave devices in electrical communication with each of SPI Bridge 00, SPI Bridge 01, SPI Bridge 10, and SPI Bridge 11. Additionally, each module includes a receive data controller, a transmit data controller, and a module ID jumper.

In other embodiments, modules 701-706 are configured to communicate with each other and/or with one or more controllers of system 700 by means of a wireless communication bus (or interface). In one example, modules 701-706 communicate with each other by means of a wireless communication interface. In another example, one or more of the modules 701-706 communicate with the controller of the system 700 via a wireless communication bus. In some cases, communication between the modules 701-706 and/or one or more controllers of the system is only via a wireless communication bus. This advantageously eliminates the need for wired interfaces in bays for receiving modules 701-706. In other cases, system 700 includes a wired interface that cooperates with the wireless interface of system 700.

Although system 700 is shown as having a single rack, systems such as system 700 may have multiple racks. In some embodiments, the system has at most 1, or 2, or 3, or 4, or 5, or 6, or 7, or 8, or 9, or 10, or 20 or 30 or 40 or 50 or 100 or 1000 or 10000 racks. In one embodiment, the system has multiple racks mounted in a side-by-side configuration.

In some embodiments, a user provides a sample to a system having one or more modules, such as system 700 of Figure 55C. The user provides this sample to the sample collection module of the system. In one embodiment, the sample collection module includes one or more lancets, needles, microneedles, phlebotomists, scalpels, cups, swabs, detergents, buckets, baskets, kits, permeable matrices, or Any other sample collection mechanism or method described elsewhere herein. Next, the system directs the sample from the sample collection module to one or more processing modules (e.g., modules 701-706) for sample preparation, assay, and/or detection. In one embodiment, the sample is directed from the acquisition module to the one or more processing modules by means of a sample processing system, such as a pipette. Next, the sample is processed in the one or more modules. In some cases, the sample is assayed in one or more modules and then subjected to one or more detection routines.

In some embodiments, after processing in one or more modules, the system communicates the results to a user or system (e.g., a server) in communication with the system. Other systems or users can then access the results to help treat or diagnose the subject.

In one embodiment, the system is configured for use with other systems, such as similar or identical systems (eg, racks, such as described in the context of FIG. 55C ) or other computer systems including servers— - Two-way communication.

The apparatus and methods provided herein can advantageously reduce the energy or carbon footprint of a point-of-service system by supporting parallel processing. In some cases, a system, such as system 700 of Figure 55C, has a footprint that is at most 10%, or 15%, or 20%, or 25%, or 30%, or 35%, of other point-of-service systems, or 40%, or 45%, or 50%, or 55%, or 60%, or 65%, or 70%, or 75%, or 80%, or 85%, or 90%, or 95%, or 99% .

In some embodiments, methods for detecting an analyte are provided. In one embodiment, the processing routine includes detecting the presence or absence of an analyte. This processing routine is facilitated by the systems and apparatus provided herein. In some cases, the analyte is associated with a biological process, physiological process, environmental condition, sample condition, disorder or stage of the disorder, such as autoimmune disease, obesity, hypertension, diabetes, neuronal and/or muscle degenerative diseases , one or more of heart disease and endocrine disease.

In some cases, the device processes one sample at a time. However, the system configuration provided here is for multiple sample processing. In one embodiment, the device processes multiple samples at once or at overlapping times. In one example, a user provides a sample to a device having multiple modules, such as system 700 of Figure 55C. The device then processes the sample by means of one or more modules of the device. In another example, a user provides multiple samples to a device having multiple modules. The device then processes the sample simultaneously with multiple modules by processing the first sample in the first module while processing the second sample in the second module.

The system can process the same type of samples or different types of samples. In one embodiment, the system processes one or more portions of the same sample simultaneously. This may be useful if various assays and/or detection protocols for the same sample are desired. In another embodiment, the system processes different types of samples simultaneously. In one example, the system processes blood and urine samples simultaneously in different modules of the system, or in a single module with processing stations for processing blood and urine samples.

In some embodiments, a method for processing a sample with a point-of-service system, such as system 700 of Figure 55C, includes accepting detection criteria or parameters, and determining a detection order or schedule based on the criteria. Detection criteria are accepted from users, systems, or servers that communicate with the point-of-service system. The criteria may be selected based on desired or predetermined effects such as: minimum time, cost, component usage, steps and/or energy. The point-of-service system processes samples according to the test sequence or schedule. In some cases, a feedback loop (coupled to the sensor) enables the point-of-service system to monitor the progress of sample processing and maintain or change the detection order or schedule. In one example, if the system detects that processing is taking longer than a predetermined amount of time set forth in the schedule, the system speeds up the processing or adjusts any parallel processing, such as sample processing in another module of the system . The feedback loop allows real-time or pseudo-real-time (eg, buffered) monitoring. In some cases, a feedback loop may provide for reflex detection, which may result in subsequent detections, assays, preparation steps, and/or other processes after initiation or completion of another detection and/or determination or sensing of one or more parameters. start. Such subsequent detections, assays, preparation steps and/or other processes can be initiated automatically without any human intervention. Optionally, reflection detection is performed in response to an assay result. That is, by way of non-limiting example, the cartridge is preloaded with reagents for Assay A and Assay B if reflection detection is scheduled. Assay A is a preliminary detection, and Assay B is a reflection detection. If the results of Assay A meet the predetermined criteria to initiate reflection detection, then Assay B is run with the same sample in the device. Plan the setup to take into account the possibility of running a reflection test. Some or all of the protocol steps of Assay B may be performed before the results of Assay A are complete. For example, sample preparation can be done ahead of time on the device. It is also possible to run reflection detection with a second sample from the patient. In some embodiments, the devices and systems provided herein can include components such that the same device can be used for reflection detection of multiple different assays and assay types. In some embodiments, multiple assays of clinical significance can be performed in a single device provided herein as part of a reflex detection protocol, where performing the same assay with known systems and methods requires two or more separate device. Thus, the systems and devices provided herein may, for example, allow reflection detection that is faster and requires less sample than known systems and methods. Furthermore, in some embodiments, for reflection detection with the apparatus provided herein, it is not necessary to know in advance which reflection detection will be performed.

In some embodiments, the point-of-service system may adhere to a predetermined detection order or schedule based on initial parameters and/or desired effects. In other embodiments, the schedule and/or detection order can be modified in real-time. May be based on one or more detected conditions, one or more additional processes to run, one or more processes no longer running, one or more processes to be modified, one or more resource/component utilization Modification, one or more detected error or alarm conditions, unavailability of one or more resources and/or components, one or more subsequent inputs or samples provided by the user, external data, or any other reason, while modifying the schedule Arrangement and/or detection sequence.

In some examples, one or more additional samples may be provided to the device after the one or more initial samples are provided to the device. Additional samples can be from the same subject or from different subjects. The additional sample can be the same type of sample as the original sample or a different type of sample (e.g., blood, tissue). Additional samples may be provided before, after, and/or concurrently with processing the one or more initial samples on the device. Additional samples may be provided with the same and/or different detection or desired criteria relative to each other and/or the initial sample. Additional samples can be processed sequentially and/or in parallel with the initial sample. Additional samples may use one or more of the same components as the original sample, or may use different components. Additional samples may or may not be required given one or more detected conditions of the initial sample.

In some embodiments, the system receives the sample by means of a sample collection module such as a lancet, scalpel, or fluid collection vessel. The system then loads or retrieves the schema for execution of one or more processing routines from the plurality of potential processing routines. In one example, the system loads a centrifugation protocol and a cell counting protocol. In some embodiments, the protocol can be loaded into the sample processing device from an external device. Alternatively, the protocol may already be on the sample processing device. Protocols can be generated based on one or more desired criteria and/or processing routines. In one example, generating a scheme may include generating a list of one or more subtasks for each input process. In some embodiments, each subtask is to be performed by a single component of one or more devices. The generation scheme may also include the order, timing and/or allocation of one or more resources to generate the list.

In one embodiment, the protocol provides processing details or instructions specific to the sample or components in the sample. For example, a centrifugation protocol can include spin rates and processing times suitable for predetermined sample densities that support density-dependent separation of the sample from other materials that may be present with the desired components of the sample.

Protocols are contained in the system, such as in the system's protocol repository, or retrieved from another system, such as a database, in communication with the system. In one embodiment, the system is in one-way communication with a database server that provides schemas to the system upon request from the system for one or more processing schemas. In another embodiment, the system is in two-way communication with the database server, which enables the system to upload user-specific processing routines to the database server for future use by the user or other users who may use the user-specific processing routines.

Referring now to Figures 56A and 56B, a shipping container 4000 may be configured to contain therein a plurality of bodily fluid samples from a plurality of subjects, such as a patient. In some embodiments, there are multiple vessels for samples from each subject. Optionally, at least two of the samples from the same subject have different chemical pretreatments, such as, but not limited to, different anticoagulants in each vessel. Alternatively, some embodiments may use a vessel having two or more separate chambers, where each chamber is configured to hold a portion of the fluid sample separate from the fluid sample in the other chamber. Some embodiments may contain the sample from the subject in a single-chambered vessel and/or a multi-chambered vessel.

As seen in FIGS. 56A and 56B , various views of one embodiment of a shipping container 4000 are shown wherein the cover panel 4010 has at least one deck portion 4012 sized to fit onto the bottom of the shipping container 4000 in the recess 4020, as seen in Figure 57A, so that the vessel 4000 can be stackable. Shipping container 4000 may have any of the features described herein for other embodiments of shipping containers described herein.

57B shows that in the shipping container 4000 there may be a pallet 4030 that is fixed and/or removable from the shipping container 4000. In one embodiment, the tray 4030 is held in place by a fixture, such as, but not limited to, a magnetic or metal portion 4032 that aligns with a metal or magnetic portion in the chassis of the shipping container 4000 to form a magnetic connection. In some embodiments, the aspect ratio of length to width is in the range of about 128:86 to 127:85. Optionally, the aspect ratio of length to width is in the range of about 130:90 to 120:80. Optionally, the length of the tray is in the range of about 130mm to 120mm and the width is in the range of about 90mm to 80mm. In some embodiments, the height or thickness of the tray is in the range of about 14 to 20 mm. The aspect ratio and/or size is configured to accommodate a tray sized to fit a slot, pocket or other holder on the plate centrifuge. In this manner, the entire tray 4030 can be centrifuged to prepare multiple samples located therein.

As seen in Figures 57A and 57B, the tray 4030 has a plurality of slots 4034, wherein the slots 4034 are sized to accommodate at least one sample storage vessel. At least one portion 4040 of the slot 4034 has a first shape and at least a second portion 4042 has a second shape different from the first shape, wherein the sample vessel can only be inserted into the slot 4034 in the desired orientation. said shape. As seen in Figure 58B, one end is semicircular and the other end is asymmetrically shaped. The tray 4030 may also be shaped with a cutout 4036 or other shape so that the tray 4030 can only be inserted into the shipping container 4000 in one orientation. It should also be appreciated that the tray 4030 can be held in the tray so that the user cannot use his or her fingers to remove the tray from the vessel 4000 without the use of tools or other tray removal devices. This minimizes the risk of user tampering. Pallet 4030 may be configured to remain within shipping container 4000 even when shipping container 4000 is upside down and to resist the pull of the earth's gravity.

Figures 59A and 59B illustrate yet another embodiment in which multiple slots 4100 are present in the tray 4102. The trays have different aspect ratios (closer to square) and have multiple shaped slots in the tray to accommodate sample vessels.

In at least some embodiments, a medical provider (or its staff where appropriate) may be the sample collector, the test result recipient, and/or both. For example, in one embodiment, a health care professional, such as, but not limited to, a dentist, may collect a sample as part of a dental procedure or independently of a dental procedure. Alternatively, some embodiments may collect samples from aspirated blood and/or saliva from a subject's dental procedure. The collected samples may be processed in the dental office and/or shipped to a receiving location that receives multiple samples for processing.

In embodiments, bodily fluid samples used in the systems, devices or methods provided herein may be diluted. In embodiments, the body fluid sample may be diluted prior to its transport from the first location to the second location. In embodiments, the bodily fluid sample may be diluted after it is transported from the first location to the second location. In embodiments, the bodily fluid sample can be diluted both before and after it is transported from the first location to the second location. In embodiments, the bodily fluid sample may be diluted after it is transported from the first location to the second location and prior to its use at the second location to perform one or more steps of laboratory testing. The original body fluid sample can be diluted, for example, by at least 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 20, 50, 100, 200, 300, 400, 500, 1000, 5,000, 10,000, 50,000 or 100,000 times. As used herein, "n-fold" dilution means the ratio by which the original sample is diluted - eg, a 5-fold diluted original sample contains the original sample at a concentration 1/5 of its original concentration after dilution (ie, the diluted sample The sample was included at a concentration 1/5 of the concentration of the sample in the original sample); similarly, the original sample diluted 500-fold contained the original sample at a concentration 1/500 of the original concentration after dilution. So, for example, if the original sample contains 5 mg protein/microliter, and it is diluted 2-fold, the diluted sample contains 2.5 mg protein/microliter. The bodily fluid sample can be divided into any number of fractions, and each fraction can be diluted to different dilutions, so that the original bodily fluid sample can be processed to obtain multiple diluted samples, each with a different dilution. Thus, for example, a raw body fluid sample may be divided into 5 parts, one part diluted 8-fold, another part 12-fold, another 3-fold, another 400-fold, and another 2,000-fold. Dilution of the sample can be performed continuously or in a single step. For a single step dilution, a selected amount of sample can be mixed with a selected amount of diluent to achieve the desired sample dilution. For serial dilution, two or more separate serial dilutions of the sample can be performed in order to achieve the desired sample dilution. For example, a first dilution of the sample can be performed and a portion of this first dilution can be used as input material for a second dilution to obtain a sample at a selected degree of dilution.

For the dilutions described herein, "original sample" and the like refers to the sample used at the beginning of a given dilution process. Thus, while a "raw sample" can be a sample obtained directly from a subject (eg, whole blood), it can also include any other sample (eg, that has been processed or used as a starting material for a given dilution process) samples that have been previously diluted in a separate dilution process).

In some embodiments, serial dilution of the sample can be performed as described below. A selected amount (e.g., volume) of the original sample can be mixed with a selected amount of diluent to obtain a first diluted sample. The first diluted sample (and any subsequent diluted samples) will have: i) a sample dilution factor (eg, the factor by which the original sample is diluted in the first diluted sample) and ii) an initial amount (eg, where the selected amount of the original sample is diluted) The total amount of the first diluted sample present after the sample is combined with the selected amount of diluent). For example, 10 microliters of the original sample can be mixed with 40 microliters of diluent to obtain a first diluted sample with a 5-fold sample dilution factor (compared to the original sample) and an initial amount of 50 microliters. Next, the selected amount of the first diluted sample can be mixed with the selected amount of diluent to obtain a second diluted sample. For example, 5 microliters of the first diluted sample can be mixed with 95 microliters of diluent to obtain a second diluted sample with a 100-fold dilution factor (compared to the original sample) and an initial amount of 100 microliters. For each of the above dilution steps, the original sample, one or more diluted samples, and the diluent can be stored or mixed in fluidly isolated vessels. Serial dilution can be continued as described above for several steps as needed to achieve the selected sample dilution level/dilution factor. For example, in embodiments, a sample can be diluted as described in U.S. Patent Application Serial No. 13/769,820, filed February 18, 2013, or any other document incorporated by reference elsewhere herein.

As used herein, an agent that is or can be used as a "diluent" is, for example, an agent that helps to increase the volume of a sample or a portion of a sample, or a liquid formulation (such as a formulation that is reconstituted after lyophilization) preparation, or reagents used to add to a sample, solution, or material for any other reason. In embodiments, the diluent can be buffered (e.g., to have a pH near pH 7 or near pH 7.4 or other desired pH) and can be pharmaceutically acceptable (safe and non-toxic for human administration). Diluents generally do not react or bind to analytes in the sample. Water can be the diluent, as can an aqueous saline solution, a buffered solution, a surfactant-containing solution, or any other solution. Exemplary diluents include sterile water, bacteriostatic water for injection (BWFI), pH buffered solutions (eg, phosphate buffered saline), sterile saline solution, Ringer's solution, or dextrose solution. In embodiments, the diluent may comprise an aqueous saline solution or buffer.

In embodiments, a bodily fluid sample, or portion thereof, collected, processed, or transported from a subject, eg, according to the systems or methods provided herein, may be divided into at least 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 20, 25, 30, 35, 40, 50, 100, 200, 300, 400, 500, 1000, 5,000, 10,000 or more different parts. For the purposes of the description provided herein of dividing a sample into portions, "original sample" and the like refers to the sample used at the beginning of a given sample dispensing process. Thus, while a "raw sample" may, for example, be a sample obtained directly from a subject (eg, whole blood), it may also include any other sample (eg, that has been processed) that is used as starting material for a given sample distribution process samples that have been or have previously been dispensed in a separate sample dispensing process). In an embodiment, the "raw sample" may be subjected to the sample distribution and dilution steps; in such cases, reference to the "raw sample" refers to the starting material used in the combined sample dilution/sample distribution process. When the sample is divided into different portions, the different portions may contain different amounts of the original sample. For example, if an original sample with a volume of 100 microliters is divided into 5 portions, one portion may contain 50 microliters of original sample, another portion may contain 25 microliters of original sample, and another portion may contain 15 microliters of original sample, Another portion may contain 8 microliters of original sample, and the last portion may contain 2 microliters of original sample. Likewise, when a sample is both diluted and divided into different portions, the different portions may have different dilutions relative to the original sample. For example, if the original sample is divided into three parts, one part can be diluted 5 times relative to the original sample, another part can be diluted 20 times relative to the original sample, and a third part can be diluted 200 times relative to the original sample.

Thus, in an example, a bodily fluid sample can be collected from a subject at a first location (eg, a sample collection site). A bodily fluid sample initially collected from a subject may be considered a "raw sample". Such a "raw sample" can be, for example, a small amount (e.g., less than 400, 300, 200 or 100 microliters) of whole blood from a subject. The "original sample" can be divided into at least a first portion and a second portion shortly after or concurrently with the collection of the "original sample" from the subject, after which the first portion is transferred to a first vessel and the second portion to a in two utensils. In embodiments, the first vessel may contain a first anticoagulant (eg, EDTA) and the second portion may contain a second anticoagulant (eg, heparin). The first and second vessels can be transported from a first location to a second location according to the systems or methods provided herein. In embodiments, at the second position, the sample or portion thereof in one or both of the vessels may be subjected to further processing or analysis steps. For example, a sample or portion thereof in one or both of the vessels may be divided into additional portions, diluted, and/or used to perform one or more assays.

In another example, a bodily fluid sample can be transported in a vessel from a first location to a second location in accordance with the systems and methods provided herein. The bodily fluid sample in the vessel can be the entire sample collected from the subject, or a portion thereof. At the second position, at least some of the bodily fluid sample in the vessel can be removed from the vessel and used for a sample dispensing and/or dilution process. The sample removed from the vessel and used in the sample distribution and/or dilution process may be considered the "original sample". The original sample may be, for example, whole blood, plasma, serum, saliva or urine, and may constitute all or part of the sample transported in the vessel. The original sample can be divided into any number of parts; each part can have different dilutions relative to the original sample. For example, the original sample removed from the shipping vessel may have less than or equal to 400, 300, 250, 200, 150, 100, 90, 80, 70, 60, 50, 40, 30, 25, 20, 15, 10, 9, 8, 7, 6, 5, 4, 3, 2, or 1 microliter volumes. The original sample removed from the shipping vessel can then be divided into at least 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 20, 25, 30, 35, 40, 50, 100, 200, 300 , 400, 500, 1000, 5,000, 10,000 or more different parts. In embodiments, the different fractions may have different dilutions relative to the original sample. For example, the different fractions can have at least 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 20, 25, 30, 35, 40, 50, 100, 200, 300, 400 relative to the original sample , 500, 1000, or 5,000 different dilutions, provided that the number of fractions with different dilutions does not exceed the total number of fractions prepared from the original sample. The different fractions can have any type of dilution relative to the original sample, including, for example, no dilution, at least 2-fold dilution, at least 3-fold dilution, at least 5-fold dilution, at least 10-fold dilution, at least 20-fold dilution, at least 50-fold dilution. At least 100-fold dilution, at least 100-fold dilution, at least 500-fold dilution, at least 1000-fold dilution, at least 5000-fold dilution, at least 10,000-fold dilution, at least 50,000-fold dilution, or at least 100,000-fold dilution. In embodiments, one or more different portions of the original sample may be used for laboratory testing. In embodiments, a portion of the original sample can be used for a laboratory test. A portion of the original sample for laboratory testing may be a diluted sample.

In embodiments, the original sample may be a whole blood sample obtained from a subject. The original sample can be obtained from the subject's finger/toe. The original sample may have no more than 400, 300, 200, 150, 100, 90, 80, 70, 60, 50, 40, 30, 25, 20, 15, 10, 9, 8, 7, 6, 5, 4, 3, 2 or 1 microliter volume. The original sample can be divided into multiple parts. The fractionation of the sample can occur before, after, or a combination of before and after the sample is transported from the first location to the second location according to the systems or methods provided herein. In embodiments, the original sample can be divided into at least 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 20, 25, 30, 35, 40, 50, 100, 200, 300, 400, 500, 1000, 5,000, 10,000 or more different parts and the different parts are used to perform at least 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 20, 25, 30, 35, 40, 50, 100, 200, 300, 400, 500, 1000, 5,000, 10,000 different laboratory tests. Different parts of the original sample may have diluted original samples. In embodiments, each laboratory test uses no more than 10, 9, 8, 7, 6, 5, 4, 3, 2, 1, 0.9, 0.8, 0.7, 0.6, 0.5, 0.4, 0.3, 0.2, 0.1 , 0.05 or 0.01 µl of the original sample.

In embodiments, the original sample may be plasma or serum obtained from a whole blood sample obtained from a subject. Whole blood can be obtained from the subject's fingers/toes. Whole blood from which plasma or serum is obtained may have no greater than 400, 300, 200, 150, 100, 90, 80, 70, 60, 50, 40, 30, 25, 20, 15, 10, 9, 8, 7, 6, 5, 4, 3, 2 or 1 microliter volumes. The plasma or serum original sample can have no more than 300, 200, 150, 100, 90, 80, 70, 60, 50, 40, 30, 25, 20, 15, 10, 9, 8, 7, 6, 5, 4 , 3, 2 or 1 microliter volume. The original sample can be divided into multiple parts. Fractionation of the sample can occur before, after, or a combination of both before and after the sample is transported from a first location to a second location in accordance with the systems or methods provided herein. In embodiments, the original sample can be divided into at least 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 20, 25, 30, 35, 40, 50, 100, 200, 300, 400, 500, 1000, 5,000, 10,000 or more different parts and the different parts are used to perform at least 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 20, 25, 30, 35, 40, 50, 100, 200, 300, 400, 500, 1000, 5,000, 10,000 different laboratory tests. Different portions of the original sample may have diluted original samples.

In embodiments, no more than 10, 9, 8, 7, 6, 5, 4, 3, 2, 1, 0.9, 0.8, 0.7, 0.6, 0.5, 0.4, 0.3, 0.2, 0.1, 0.05, or 0.01 microns are used The equivalent in liters of the original sample was used for laboratory testing. For example, if the original sample is whole blood, and the original sample is divided into multiple parts, and at least one part contains a diluted sample containing the original sample that has been diluted 100-fold, and 5 microliters of all Using the diluted sample described above to perform a laboratory assay, an equivalent of 0.05 microliters of the original sample (eg, whole blood) was used to perform the assay (5 microliters x 1/100 dilution). In another example, the original sample can be whole blood. The whole blood can be processed to obtain plasma [e.g., by separating the liquid components of the blood from the solid components of the blood (e.g., cells)]. A volume of plasma may be obtained from a volume of whole blood - for example, the volume of plasma obtainable from a volume of whole blood may be at least or about 30%, 40%, 50%, 60% of the volume of whole blood, for example % or 70%. Thus, for example, if the volume of plasma from whole blood is 50%, 1 ml of plasma can be obtained from 2 ml of whole blood. Plasma from whole blood can be further diluted, and one or more of the diluted portions of plasma can be used to perform one or more laboratory tests. In another example, the original sample can be whole blood. Whole blood can be processed to obtain plasma, where the volume of plasma from whole blood is 60% of the volume of whole blood (e.g., 60 microliters of plasma is obtained from 100 microliters of whole blood). Plasma can be diluted 10 times. Laboratory tests can be performed using 2 microliters of diluted plasma. Therefore, for this laboratory assay, an equivalent of approximately 0.33 microliters of the original sample (whole blood) was used to perform the assay (2 microliters x 1/10 dilution x 100/60 whole blood/plasma conversion). In another example, the original sample may be plasma, and the original sample may be divided into multiple portions, and at least one portion includes a diluted sample that includes the original sample that has been diluted 50-fold, and using 4 micron liters of this diluted sample to perform a laboratory assay, an equivalent of 0.08 microliters of the original sample (eg, plasma) was used to perform the assay (4 microliters x 1/50 dilution).

In embodiments, the original sample can be divided into at least 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 20, 25, 30, 35, 40, 50, 100, 200, 300, 400, 500, 1000, 5,000, 10,000 or more different parts, and the different parts can be used to perform at least 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 20, 25, 30, 35, 40, 50, 100, 200, 300, 400, 500, 1000, 5,000, 10,000 different laboratory tests. In some embodiments, at least as many sample portions are prepared as laboratory tests are performed on a portion of the sample (eg, to perform 10 laboratory tests with an original sample, the original sample may be divided into at least 10 portions, each detection using at least 1 part). In certain other embodiments, more than one laboratory test can be performed with a single sample. For example, in embodiments, an optical property of a sample (e.g., cell count in a blood sample) can be measured, and the same sample can then be used to determine an analyte in the blood. Thus, in some embodiments, more laboratory tests can be performed on a raw sample than the number of parts prepared from the same raw sample (e.g., 10 laboratory tests can be performed from a raw sample divided into only 8 parts).

When the original sample is divided into multiple parts, and the multiple parts are used to perform two or more laboratory tests, the laboratory tests may be the same type of laboratory tests, or they may be different types of laboratory tests . For example, if the original sample is divided into 10 parts, and the 10 parts are each used for a laboratory test, the laboratory test performed with each of the parts can be an immunoassay. In another example, if the original sample is divided into 5 parts, and each of the 5 parts is used for a laboratory test, the laboratory test performed with each of the parts may be a nucleic acid amplification-based test.

In other cases, when the original sample is divided into multiple parts, and the multiple parts are used to perform two or more laboratory tests, the at least two laboratory tests may be different types of laboratory tests. For example, if the original sample is divided into 5 parts, and each of the 5 parts is used for laboratory testing, then 2 of the parts can be used for immunoassays (eg, ELISA) and 3 of the parts can be used for nucleic acid amplification-based detection.

Bodily fluid samples, or portions thereof, transported according to the systems or methods provided herein can be used in various types of laboratory assays, such as immunoassays, nucleic acid amplification assays, general chemistry assays, or cytometry assays. In embodiments, bodily fluid samples, or portions thereof, transported according to the systems or methods provided herein may be used, for example, in US Patent Application Serial No. 13/769,820, filed February 18, 2013, or elsewhere herein incorporated by reference in any type of assay or laboratory test described in any other document.

In some embodiments, bodily fluid samples or portions thereof transported according to the systems or methods provided herein can be used in immunoassays. As used herein, "immunoassay" refers to any assay that involves the detection of an analyte with an antibody having affinity for the analyte. Immunoassays can include, for example, enzyme-linked immunosorbent (ELISA) assays, and can include competitive and non-competitive based assays. As used herein, the term "antibody" refers to immunoglobulin molecules and immunologically active portions of immunoglobulin molecules, ie, comprising antigen-binding units ("Abu" or plural numbers) that specifically bind ("immunoreactive" with) an antigen. "Abus"). Structurally, the simplest naturally occurring antibodies (e.g., IgG) comprise four polypeptide chains—two heavy (H) and two light (L) chains, connected by disulfide bonds. Immunoglobulins represent a large family of molecules that include several types of molecules, such as IgD, IgG, IgA, IgM and IgE. The term "immunoglobulin molecule" includes, for example, hybrid antibodies or altered antibodies, and fragments thereof. Based on their molecular structure, antigen-binding units can be broadly classified into "single-chain" ("Sc") and "non-single-chain" ("Nsc") types.

Also included in the terms "antibody" and "antigen binding unit" are immunoglobulin molecules and fragments thereof, which may be human, non-human (derived from vertebrates or invertebrates), chimeric or humanized. For a description of the concept of chimeric and humanized antibodies, see Clark et al., 2000 and references cited therein (Clark, (2000) Immunol. Today 21:397-402). In embodiments, an "immunoassay" as provided herein may also include wherein the analyte to be measured in the assay is an antibody, and the antibody is probed with a molecule having affinity for the antibody (eg, a target molecule of the antibody) measurement.

In some embodiments, bodily fluid samples or portions thereof transported according to the systems or methods provided herein can be used in nucleic acid amplification assays. As used herein, a "nucleic acid amplification assay" refers to an assay in which the copy number of a target nucleic acid can be increased. Nucleic acid amplification assays can include isothermal and temperature-variable amplification techniques, and include, for example, techniques such as polymerase chain reaction (PCR) and loop-mediated isothermal amplification (LAMP). Typically, nucleic acid amplification assays include at least i) a nucleic acid polymerase, ii) primers that can bind to target nucleic acid sequences, and iii) free nucleotides that can be incorporated into synthesized nucleic acids by the polymerase. Amplification of the target nucleic acid can be detected in various ways, such as measuring the fluorescence or turbidity of the reaction over a period of time.

In some embodiments, bodily fluid samples, or portions thereof, transported according to the systems or methods provided herein can be used in general chemical assays. General chemical assays may include, for example, analysis of the Basic Metabolic Panel [Glucose, Calcium, Sodium (Na), Potassium (K), Chloride (Cl), CO2 (Carbon Dioxide, Bicarbonate), Creatinine, Measurement of blood urea nitrogen (BUN)], measurement of Electrolyte Panel [sodium (Na), potassium (K), chloride (Cl), CO2 (carbon dioxide, bicarbonate)], measurement of Chem 14 panel /Comprehensive Metabolic Panel (Chem14Panel/Comprehensive Metabolic Panel) [Glucose, Calcium, Albumin, Total Protein, Sodium (Na), Potassium (K), Chloride (Cl), CO2 (Carbon Dioxide, Bicarbonate), Creatinine , blood urea nitrogen (BUN), alkaline phosphatase (ALP), alanine aminotransferase (ALT/GPT), aspartate aminotransferase (AST/GOT), determination of total bilirubin], blood lipid profile/blood lipid Panel (Lipid Profile/Lipid Panel) [LDL cholesterol, HDL cholesterol, total cholesterol and triglycerides] determination, liver panel/Liver Function (Liver Panel/Liver Function) [alkaline phosphatase (ALP), alanine Transaminase (ALT/GPT), aspartate aminotransferase (AST/GOT), total bilirubin, albumin, total protein, gamma-glutamyltransferase (GGT), lactate dehydrogenase (LDH), thrombin Proto-time (PT)], alkaline phosphatase (APase), hemoglobin, VLDL cholesterol, ethanol, lipase, pH, zinc protoporphyrin, direct bilirubin, blood typing (ABO, RHD), lead, phosphate , hemagglutination inhibition, magnesium, iron, iron uptake, fecal occult blood, etc., alone or in any combination.

In the general chemical assays provided herein, in some examples, the level of an analyte in a sample is determined by one or more assay steps involving the reaction of an analyte of interest with one or more reagents, Causes a detectable change in the reaction (eg, a change in the turbidity of the reaction, the production of luminescence in the reaction, a change in the color of the reaction, etc.). In some examples, the properties of the sample are determined by one or more assay steps involving the reaction of the sample of interest with one or more reagents, resulting in a detectable change in the reaction (eg, reaction turbidity) change in degree, luminescence in reaction, change in reaction color, etc.). Generally, "general chemistry" assays as used herein do not involve amplification of nucleic acids, imaging of cells at the microscopy stage, or determination of analyte levels in solution based on the use of labeled antibodies/conjugates to determine analyte levels in solution level determination. In some embodiments, general chemical assays are performed with all reagents in a single vessel—ie, in order to perform a reaction, all necessary reagents are added to the reaction vessel, and no material is removed from the reaction or the reaction vessel during the assay process (eg there is no wash step; it is a "mix and read" reaction). Common chemical assays can also be, for example, colorimetric assays, enzymatic assays, spectroscopic assays, turbidimetric assays, agglutination assays, coagulation assays, and/or other types of assays. Many common chemical assays can be analyzed by measuring the absorbance of light of one or more selected wavelengths by the assay reaction (e.g., with a spectrophotometer). In some embodiments, general chemical assays can be analyzed by measuring the turbidity of the reaction (e.g., with a spectrophotometer). In some embodiments, general chemical assays can be analyzed by measuring the chemiluminescence produced in the reaction, such as with a PMT, photodiode, or other optical sensor. In some embodiments, general chemistry assays can be performed computationally based on experimental values determined for one or more other analytes in the same or related assays. In some embodiments, the fluorescence of the reaction can be measured by measuring the fluorescence of the reaction (eg, with a detection unit comprising or connected to i) a light source of one or more specific wavelengths ("excitation wavelengths"); and ii) a sensor configured with General chemical assays are analyzed by detecting the emitted light at one or more specific wavelengths ("excitation wavelengths"). In some embodiments, general chemical assays can be analyzed by measuring agglutination in the reaction (e.g., by measuring the turbidity of the reaction with a spectrophotometer or by obtaining an image of the reaction with an optical sensor). In some embodiments, general chemical assays can be analyzed by imaging the reaction at one or more time points (e.g., imaging with a CCD or CMOS optical sensor) followed by image analysis. Alternatively, the analysis may involve prothrombin time, activated partial thromboplastin time (APTT), any of which may be measured by methods such as, but not limited to, turbidimetry. In some embodiments, general chemical assays can be analyzed by measuring the viscosity of the reaction (e.g., with a spectrophotometer, where an increase in the viscosity of the reaction changes the optical properties of the reaction). In some embodiments, the reaction can be measured by measuring complex formation between two non-antibody reagents (eg, a metal ion and a chromophore; such a reaction can be measured spectrophotometrically or by colorimetry using another device). Analytical General Chemistry Assays. In some embodiments, general chemical assays can be analyzed by non-ELISA or cytometry-based methods for determining cellular antigens (e.g., hemagglutination assays for blood group, which can be measured, e.g., by the turbidity of the reaction). In some embodiments, general chemical assays can be analyzed by means of electrochemical sensors, such as electrochemical sensors for carbon dioxide or oxygen. Additional methods can also be used to analyze general chemical assays.

In some embodiments, a spectrophotometer can be used to measure general chemical assays. In some embodiments, general chemistry assays can be measured at the end of the assay ("endpoint" assay) or at two or more times during the course of the assay ("time course" or "kinetic" assay).

In some embodiments, bodily fluid samples or portions thereof transported according to the systems or methods provided herein can be used in cytometric assays. Cytometric assays are commonly used to optically, electrically or acoustically measure characteristics of individual cells. For the purposes of this disclosure, a "cell" can include acellular samples that are generally similar in size to individual cells, including but not limited to vesicles (eg, liposomes), small populations of cells, virions, bacteria, protozoa, crystals, Entities formed by the polymerization of lipids and/or proteins, and substances bound to small particles such as beads or microspheres. Such characteristics include, but are not limited to, size; shape; granularity; light scattering pattern (or optical characteristic curve); whether cell membranes are intact; content, nucleic acid modifications, organelle content, nuclear structure, nuclear content, internal cell structure, internal vesicle content (including pH), ionic concentration and presence of other small molecules such as steroids or drugs; and cell surface (both cell membrane and cell wall) Markers, including proteins, lipids, carbohydrates, and modifications thereof. By using appropriate dyes, stains, or other labeling molecules, whether in pure form, conjugated to other molecules, or immobilized or bound to nanoparticles or microparticles, cell counting can be used to determine specific proteins, nucleic acids, lipids, carbohydrates The presence, amount and/or modification of a compound or other molecule. Cytometric analysis can be performed, for example, by flow cytometry or microscopy. Flow cytometry typically uses a flowing liquid medium, which in turn carries individual cells to optical, electrical, or acoustic wave detectors. Microscopy typically uses optical or acoustic means to detect fixed cells, usually by recording at least one magnified image. In embodiments, a cytometry assay may involve obtaining an image of one or more cells in a sample. In embodiments, the sample can be provided on or in a microscope slide or cuvette that can allow cells in the sample to settle in a desired configuration for imaging. Images of cells can be obtained with, for example, CCD or CMOS based cameras.

In some embodiments, the types of laboratory tests can be classified based on how the results of the tests were detected. Different types of laboratory test result detection can include, for example, i) luminescence detection; ii) fluorescence detection; iii) absorbance detection; iv) light scattering detection; and v) imaging. Each of these detection methods is described, for example, in U.S. Patent Application Serial No. 13/769,820, filed February 18, 2013, which is hereby incorporated in its entirety for all purposes. Briefly, luminescence can be detected from detection that produces a measurable light signal. Such a reaction may be, for example, a chemiluminescent reaction. To detect the result of the luminescent reaction, a light detector such as a PMT or photodiode can be used to detect the light from the assay unit containing the luminescent reaction. Fluorescence can be detected, for example, with an optical device comprising a light source and a light detector. A light source may emit light of one or more specific wavelengths. The assay cell containing the detection material can be positioned in the path of the light source such that the one or more specific wavelengths of light reach the contents of the assay cell (one or more "excitation wavelengths"). The assay unit may contain a molecule of interest that absorbs light at one or more specific wavelengths from a light source, at least in some cases, and subsequently emits light of a different wavelength. The photodetector can be configured to detect light (one or more "emission wavelengths") released by the molecule of interest. The light source and/or the light detector may include a bandpass filter after the light source or before the light detector in order to limit one or more wavelengths of light from the light source or reaching the light detector. The light source may be, for example, a light bulb, a laser or an LED, and the light detector may be, for example, a PMT or a photodiode. Absorbance can be detected, for example, with an optical device comprising a light source and a light detector. The light source and the photodetector can be in line with each other and configured such that an assay unit containing the detection material can be positioned between the light source and the photodetector so that some light can pass through the detection material to the photodetector and some light can be absorbed. Based on the results of the detection, different amounts of light can be absorbed by the detection material. Similarly, light transmission through the detection material can be determined. For absorption/transmission determination assays, one or more wavelengths of light emitted by the light source may be the same as one or more wavelengths of light detected by the light detector. The light source can be, for example, a light bulb, a laser or an LED, and the light detector can be, for example, a PMT or a photodiode. Light scattering can be detected, for example, with an optical device comprising a light source and a light detector. The light source and the photodetector may be angled relative to each other and configured such that the assay unit containing the detection material may be in line with both the light source and the photodetector so that light from the light source may reach the assay unit and be assayed by the detection material in the unit scattered to reach the photodetector. Based on the results of the detection, different amounts of light can be scattered by the detection material. The light source can be, for example, a light bulb, a laser or an LED, and the light detector can be, for example, a PMT or a photodiode. An image of the detection material can be obtained, for example, by a detector comprising an image sensor (e.g., a CCD or CMOS sensor). Typically, an image sensor will be included in the camera. The image of the inspection material can be analyzed, for example, by automated or manual image analysis, in order to determine the inspection result. The bodily fluid samples provided herein can also be used in laboratory testing to detect results by non-optical based detection methods (e.g., measuring conductivity, radioactivity, or temperature).

In an embodiment, in order to perform an assay/detection with a portion of the bodily fluid sample, the portion of the bodily fluid sample may be transferred to an assay unit for at least one step in the assay/detection. Assay units can have various form factors, such as pipette tips, tubes or microscope slides. The steps of an assay that can occur in an assay unit can include, for example, binding of an analyte in a sample to a binder (eg, an antibody) directed against the analyte, amplifying a target nucleic acid in a sample in a nucleic acid amplification reaction, based on a The addition of reagents or reagents to the sample coagulates the sample or adopts a configuration for optical analysis (eg, cells settle on the surface of a microscope slide to facilitate obtaining one or more images of the cells). As used herein, the terms "assay" and "detection" are used interchangeably unless the context clearly dictates otherwise.

Example

The following examples are offered for illustrative purposes only, and are not intended to limit the present disclosure in any way.

Example 1

Whole blood samples are obtained from subjects. The whole blood sample was centrifuged in a vessel to separate the whole blood into pelleted cells and plasma supernatant. The centrifuged vessel was moved to an argon purged glove box. Plasma was aspirated from the centrifuged vessel and then aliquoted into 5 separate sample vessels as provided herein, wherein the sample vessels each had an internal volume of no greater than 100 microliters, wherein no greater than 95 microliters of plasma was aliquoted. into each sample vessel, and wherein each sample vessel is the same size and receives the same volume of plasma. The vessels each have a removable butyl rubber cap. The 5 sample vessels were associated with the labels "0 hours", "1 hour", "2 hours", "8 hours" and "24 hours". Assays for bicarbonate were performed on the samples in each vessel at the corresponding time period associated with each sample vessel. The results of the assay are provided in Table 1 below.

Table 1

As shown in Table 1, in the sample vessels provided herein, the bicarbonate salts in the samples were stable for at least 24 hours.

Example 2

Whole blood samples are obtained from subjects. EDTA was mixed with the whole blood sample. Aliquot 80 microliters of EDTA-containing blood into each of 10 sample vessels as provided herein, wherein each sample vessel has an internal volume of no greater than 100 microliters and is the same size. The sample vessels were associated with the following tags for analysis: Real Time: Day 1, Day 2, Day 3, Day 4, Day 5 and Day 7; Pre-centrifuged: Day 1, Day 2, Days 4 and 7. Each "pre-centrifuged" vessel was centrifuged when the sample was aliquoted into the vessel to generate plasma and pelleted cells. Each "live" vessel was centrifuged on the corresponding day to generate plasma and pelleted cells. After aliquoting the sample into each sample vessel, cap it. On the corresponding day for each vessel, plasma was removed from the vessel and assayed for blood urea nitrogen (BUN). The BUN assay results are shown in the graph of FIG. 48 . As shown in this graph, in the sample vessels provided herein, BUN in the samples remained stable for at least 7 days, in both whole blood and plasma samples.

The publications discussed or described herein are provided for their disclosure prior to the filing date of the present application. Nothing herein should be construed as an admission that the present invention is not entitled to antedate such publication by virtue of prior invention. In addition, the date of publication provided may differ from the actual date of publication, which may need to be independently confirmed. All publications mentioned herein are incorporated herein by reference to disclose and describe the structures and/or methods in connection with which the publications are cited. The following applications are hereby incorporated by reference in their entirety for all purposes: US Provisional Patent Application No. 61/435,250 ("SYSTEMS AND METHODS FOR SAMPLE USEMAXIMIZATION") filed January 21, 2011 and US Patent Publication No. 2009/ 0088336 (“MODULAR POINT-OF-CARE DEVICES, SYSTEMS, AND USES THEREOF”). The following applications are also hereby incorporated by reference in their entirety for all purposes: US Patent Publication 2005/0100937; US Patent 8,380,541; US Patent Application Serial No. 61/766,113, filed February 18, 2013; US Patent Application Serial No. 13/769,798, filed February 18; US Patent Application Serial No. 13/769,779, filed February 18, 2013; US Patent Application Serial No. 13/769,820, filed February 18, 2013; US Patent Application Serial No. 13/244,947, filed September 26, 2011; PCT/US2012/57155, filed September 25, 2012; US Application Serial No. 13/244,946, filed September 26, 2011; US Patent Application No. 13/244,949, filed September 26, 2011; and US Application Serial No. 61/673,245, filed September 26, 2011, the disclosures of all of which are hereby incorporated by reference in their entirety here.

Implementation

In one embodiment described herein, there is provided an apparatus for collecting a bodily fluid sample from a subject, comprising: at least two sample collection paths configured for transferring the bodily fluid sample from and to the A single end of the device in contact with the subject is drawn into the device, thereby separating the fluid sample into two separate samples; a second portion comprising a second portion for receiving a sample collected in the sample collection channel; A plurality of sample vessels for the bodily fluid sample, the sample vessels being operably engageable in fluid communication with the sample collection passage, such that when fluid communication is established, the vessels provide power to separate the two separate vessels. The bulk of the sample moves from the passage into the vessel.

In another embodiment described herein, there is provided a device for collecting a bodily fluid sample, comprising: a first portion including at least one fluid collection location leading to at least two sample collection passages, the sample collection passages is configured to draw a fluid sample therein via a power of a first type; a second portion comprising a plurality of sample vessels for receiving the bodily fluid sample collected in the sample collection passage, the sample vessels may be operatively engaged in fluid communication with the sample collection passage, whereby when fluid communication is established, the vessel provides a second power different from the first power to move a substantial portion of the bodily fluid sample from the passage into the vessel; wherein at least one of the sample collection passages includes a fill indicator for indicating when a minimum fill level is reached and at least one of the sample vessels can be engaged for collection with the sample At least one of the passages is in fluid communication.

In another embodiment described herein, there is provided a device for collecting a bodily fluid sample, comprising: a first portion including at least two sample collection channels configured for via a first type Dynamically draws a fluid sample into the sample collection channels, wherein one of the sample collection channels has an internal coating designed to mix with the fluid sample and the other of the sample collection channels has a chemically different another inner coating on the inner coating; a second portion comprising a plurality of sample vessels for receiving the bodily fluid sample collected in the sample collection channel, the sample vessels being operable engages in fluid communication with the collection channel, whereby when fluid communication is established, the vessel provides a second power different from the first power to move a substantial portion of the bodily fluid sample from the channel to the in vessels; wherein the vessels are arranged such that mixing of the fluid sample between the vessels does not occur.

In another embodiment described herein, there is provided a device for collecting a bodily fluid sample, comprising: a first portion including a plurality of sample collection channels, wherein at least two of the channels are configured for use via A first type of power simultaneously draws a fluid sample into each of the at least two sample collection channels; a second portion includes a plurality of a sample vessel, wherein the sample vessel has a first condition in which the sample vessel is not in fluid communication with the sample collection channel and a second condition in which the sample vessel is not in fluid communication with the sample collection channel can be operably engaged in fluid communication with the collection channel such that when fluid communication is established, the vessel provides a second power different from the first power to move the bodily fluid sample from the channel to the vessel middle.

In another embodiment described herein, there is provided a sample collection device comprising: (a) a collection channel that includes a first opening and a second opening and is configured for wicking from the first opening via capillary action an opening for aspirating a bodily fluid sample toward the second opening; and (b) a sample vessel for receiving the bodily fluid sample, the vessel engageable with the collection channel, having an interior having a vacuum therein, and having a configured a cap for a receiving channel; wherein the second opening is defined by a portion of the collection channel, the portion being configured to penetrate the cap of the sample vessel, and providing the collection channel with the A fluid flow path between sample vessels, and the sample vessels have an interior volume no greater than ten times the interior volume of the collection channel.

In another embodiment described herein, there is provided a sample collection device comprising: (a) a collection channel that includes a first opening and a second opening and is configured for wicking from the first opening via capillary action an opening towards the second opening to aspirate a bodily fluid sample; (b) a sample vessel for receiving the bodily fluid sample, the vessel engageable with the collection channel, having an interior with a vacuum therein, and having an interior configured for a cap on the collection channel; and (c) an adapter channel configured to provide a fluid flow path between the collection channel and the sample vessel, having a first opening and a second opening, the first opening The second opening is configured to contact the collection channel, the second opening is configured to penetrate the cap of the sample vessel.

In another embodiment described herein, there is provided a sample collection device comprising: (a) a body comprising a collection channel comprising a first opening and a second opening and configured to pass through capillary action draws bodily fluid from the first opening towards the second opening; (b) a base comprising a sample vessel for receiving a sample of the bodily fluid, the sample vessel engageable with the collection channel, having having an interior with a vacuum therein, and having a cap configured to receive a channel; and (c) a bracket, wherein the body and the base are connected to opposite ends of the bracket and are configured to be relative to the bracket are moved relative to each other such that the sample collection device is configured to have an extended state and a compressed state, wherein at least a portion of the base is closer to the body in the extended state of the device than in the compressed state, so The second opening of the collection channel is configured to penetrate the cap of the sample vessel, in the extended state of the device, the second opening of the collection channel is not in contact with the sample vessel. the interiors are in contact, and in the compressed state of the device, the second opening of the collection channel extends through the cap of the vessel into the interior of the sample vessel, Fluid communication between the collection channel and the sample vessel is thereby provided.

In another embodiment described herein, there is provided a sample collection device comprising: (a) a body comprising a collection channel comprising a first opening and a second opening and configured to pass through capillary action draws bodily fluid from the first opening towards the second opening; (b) a base comprising a sample vessel for receiving a sample of bodily fluid, the sample vessel engageable with the collection channel, having therein an interior having a vacuum and having a cap configured to receive the channel; (c) a bracket, and (d) an adapter channel having a first opening and a second opening, the first opening configured to contact the the second opening of the collection channel, and the second opening is configured to penetrate the cap of the sample vessel, wherein the body and the base are connected to opposite ends of the holder, and are configured to be movable relative to each other such that the sample collection device is configured to have an expanded state and a compressed state, wherein at least a portion of the base is more in the expanded state of the device than in the compressed state Proximate the body, in the extended state of the device, the adapter channel is not in contact with either or both of the collection channel and the interior of the sample vessel, and in the device In the compressed state, the first opening of the adapter channel is in contact with the second opening of the collection channel, and the second opening of the adapter channel passes through the vessel's A cap extends into the interior of the sample vessel to provide fluid communication between the collection channel and the sample vessel.

In another embodiment described herein, there is provided a device for collecting a fluid sample from a subject, comprising: (a) a body comprising a collection channel comprising a first opening and a second two openings and configured to draw bodily fluids from the first opening towards the second opening via capillary action; (b) a base engageable with the body, wherein the base supports a sample vessel, The vessel is engageable with the collection channel, has an interior having a vacuum therein, and has a cap configured to receive the channel; wherein the second opening of the collection channel is configured to penetrate the the cap of the sample vessel, and providing a fluid flow path between the collection channel and the sample vessel.

In another embodiment described herein, there is provided a device for collecting a fluid sample from a subject, comprising: (a) a body comprising a collection channel comprising a first opening and a second two openings and configured to draw bodily fluids from the first opening towards the second opening via capillary action; (b) a base engageable with the body, wherein the base supports a sample vessel, The sample vessel is engageable with the collection channel, has an interior having a vacuum therein, and has a cap configured to receive the channel; and (c) an adapter channel having a first opening and a second opening, the The first opening is configured to contact the second opening of the collection channel, and the second opening is configured to penetrate the cap of the sample vessel.

It should be appreciated that one or more of the following features may be adapted for use with any of the embodiments described herein. By way of non-limiting example, the body may include two collection channels. Optionally, the interior of one or more of the collection channels is coated with an anticoagulant. Optionally, the main body includes a first collection channel and a second collection channel, and the inside of the first collection channel is coated with a different anticoagulant than the inside of the second collection channel. Optionally, the first anticoagulant is ethylenediaminetetraacetic acid (EDTA) and the second anticoagulant is different from EDTA. Optionally, the first anticoagulant is citrate and the second anticoagulant is different from citrate. Optionally, the first anticoagulant is heparin and the second anticoagulant is different from heparin. Optionally, one anticoagulant is heparin and the second anticoagulant is EDTA. Optionally, one anticoagulant is heparin and the second anticoagulant is citrate. Optionally, one anticoagulant is citrate and the second anticoagulant is EDTA. Optionally, the body is formed of a light transmissive material. Optionally, the device includes the same number of sample vessels as collection channels. Optionally, the device includes the same number of adapter channels as collection channels. Optionally, the base includes an optical indicator that provides a visual indication of whether the sample has reached the sample vessel in the base. Optionally, the base is a window that allows a user to view the vessel in the base. Optionally, the support includes a spring, and the spring applies a force such that when the device is in its natural state, the device is in the extended state. Optionally, the second opening of the collection channel or the adapter channel is capped by a sleeve, wherein the sleeve does not prevent movement of bodily fluids from the first opening towards the second opening via capillary action. Optionally, the sleeve includes a drain hole. Optionally, each collection channel can hold a volume no greater than 500 uL. Optionally, each collection channel can hold a volume of no more than 200 uL. Optionally, each collection channel can hold a volume no greater than 100 uL. Optionally, each collection channel can hold a volume no greater than 70 uL. Optionally, each collection channel can hold a volume no greater than 500 uL. Optionally, each collection channel can hold a volume no greater than 30 uL. Optionally, the inner perimeter of the cross-section of each collection channel is no greater than 16 mm. Optionally, the inner perimeter of the cross-section of each collection channel is no greater than 8 mm. Optionally, the inner perimeter of the cross-section of each collection channel is no greater than 4 mm. Optionally, the inner perimeter is a circumference. Optionally, the device includes a first collection channel and a second collection channel, and the opening of the first channel is adjacent to the opening of the second channel, and the opening is configured for simultaneous removal from a single drop of blood Blood collection. Optionally, the opening of the first channel and the opening of the second channel have a center-to-center spacing of less than or equal to about 5 mm. Optionally, each sample vessel has an interior volume no greater than twenty times the interior volume of the collection channel into which it can engage. Optionally, each sample vessel has an interior volume no greater than ten times the interior volume of the collection channel into which it can engage. Optionally, each sample vessel has an interior volume no greater than five times the interior volume of the collection channel into which it can engage. Optionally, each sample vessel has an interior volume no greater than twice the interior volume of the collection channel into which it can engage. Optionally, establishment of fluid communication between the collection channel and the sample vessel results in the transfer of at least 90% of the bodily fluid sample in the collection channel into the sample vessel.

It should be appreciated that one or more of the following features may be adapted for use with any of the embodiments described herein. Optionally, establishment of fluid communication between the collection channel and the sample vessel results in the transfer of at least 95% of the bodily fluid sample in the collection channel into the sample vessel. Optionally, establishment of fluid communication between the collection channel and the sample vessel results in the transfer of at least 98% of the bodily fluid sample in the collection channel into the sample vessel. Optionally, the establishment of fluid communication between the collection channel and the sample vessel results in the transfer of the bodily fluid sample into the sample vessel and causes no more than 10 uL of the bodily fluid sample to remain in the collection channel. Optionally, the establishment of fluid communication between the collection channel and the sample vessel results in the transfer of the bodily fluid sample into the sample vessel and causes no more than 5 uL of the bodily fluid sample to remain in the collection channel. Optionally, engagement of the collection channel with the sample vessel results in the transfer of the bodily fluid sample into the sample vessel and causes no more than 2 uL of the bodily fluid sample to remain in the collection channel.

In another embodiment described herein, there is provided a method comprising: contacting one end of a sample collection device with a bodily fluid sample for aspiration into at least two collection channels of the sample collection device via a first type of power the sample to divide the sample into at least two parts; after it has been confirmed that a desired amount of sample fluid is in at least one of the collection channels, establishing fluid between the sample collection channel and the sample vessel communication, the vessel then provides a second power, different from the first power, to move each portion of the bodily fluid sample into its corresponding vessel.

In another embodiment described herein, there is provided a method comprising: metering a minimum amount of sample into at least two channels by using a sample collection device having at least one of the sample collection channels Two, the at least two sample collection channels are configured to simultaneously draw a fluid sample into each of the at least two sample collection channels via a power of the first type; After being in the collection channel, fluid communication is established between the sample collection channel and the sample vessel, whereupon the vessel provides a second power, different from the first power used to collect the sample, to remove the bodily fluid sample from the sample. The channel moves into the vessel.

In another embodiment described herein, there is provided a method of collecting a bodily fluid sample comprising: (a) contacting the bodily fluid sample with a device including a collection channel including a first opening and a second opening , and is configured to aspirate body fluid from the first opening towards the second opening via capillary action such that the body fluid sample fills the collection channel from the first opening through the second opening; ( b) establishing a fluid flow path between the collection channel and the interior of a sample vessel, the sample vessel having an interior volume no greater than ten times the interior volume of the collection channel, and between the collection channel and the sample The establishment of the fluid flow path between the interior of the vessel is preceded by a vacuum so that the establishment of the fluid flow path between the collection channel and the interior of the sample vessel is at the second of the collection channel Negative pressure is generated at the opening and fluid sample is transferred from the collection channel to the interior of the sample vessel.

In another embodiment described herein, there is provided a method of collecting a bodily fluid sample comprising: (a) contacting the bodily fluid sample with any collection device as described herein such that the bodily fluid sample is removed from the a first opening of at least one of the one or more collection channels in the device fills the collection channel through a second opening; and (b) establishes a fluid flow path between the collection channel and the interior of the sample vessel , such that establishing a fluid flow path between the collection channel and the interior of the sample vessel generates a negative pressure at the second opening of the collection channel, and transfers the fluid sample from the collection channel to the the interior of the sample vessel.

It should be appreciated that one or more of the following features may be adapted for use with any of the embodiments described herein. Optionally, the collection channel is not in fluid communication with the interior of the sample vessel until bodily fluids reach the second opening of the collection channel. Optionally, the device includes two collection channels, and the collection channels are not brought into fluid communication with the interior of the sample vessel until bodily fluids reach the second openings of both collection channels. Optionally, the second opening of the collection channel in the device is configured to penetrate the cap of the sample vessel, and wherein the second opening of the collection channel is provided in contact with the sample vessel. relative movement between the sample vessels such that the second opening of the collection channel penetrates the cap of the sample vessel to establish a gap between the second opening of the collection channel and the sample vessel fluid flow path. Optionally, the device includes an adapter channel for each collection channel in the device, the adapter channel having a first opening and a second opening, the first opening configured to contact the collection channel the second opening, and the second opening is configured to penetrate the cap of the sample vessel, and wherein by providing (a) the second opening of the collection channel, (b) the Relative movement between two or more of the adapter channels and (c) the sample vessel such that the second opening of the adapter channel penetrates the cap of the sample vessel to establish the A fluid flow path between the collection channel and the sample vessel.

In another embodiment described herein, there is provided a method for collecting a bodily fluid sample from a subject, comprising: (a) connecting a device comprising a first channel and a second channel with a sample from the subject body fluids of a person are in fluid communication, each channel has an input opening configured for fluid communication with the body fluid, each channel has an output opening located downstream of the input opening of each channel, and each channel is configured to draw bodily fluid from the input opening towards the output opening via capillary action; (b) passing the output opening of each of the first channel and the second channel, causing the first channel Channels and said second channels are in fluid communication with first and second vessels, respectively; and (c) directing said bodily fluid within each of said first and second channels by means of To each of the first vessel and the second vessel: (i) a negative pressure relative to ambient pressure in the first vessel or the second vessel, wherein the negative pressure is sufficient to generate the body fluid Flow through said first channel or said second channel into its corresponding vessel, or (ii) positive pressure relative to ambient pressure upstream of said first channel or said second channel, wherein all The positive pressure is sufficient to induce flow of the whole blood sample through the first channel or the second channel into its corresponding vessel.

In another embodiment described herein, there is provided a method of manufacturing a sample collection device comprising: forming a portion of a sample collection device having at least two channels configured for simultaneous via a first type of power drawing a fluid sample into each of the at least two sample collection channels; forming a sample vessel, whereupon the vessel is configured to be coupled to the sample collection device to provide a different The second power of the first power, thereby moving the bodily fluid sample from the channel into the vessel.

In another embodiment described herein, computer-executable instructions are provided for performing a method comprising forming a portion of a sample collection device having at least two channels configured for A fluid sample is simultaneously drawn into each of the at least two sample collection channels via a power of the first type.

In another embodiment described herein, computer-executable instructions are provided for performing a method comprising: forming a sample vessel, whereupon the vessel is configured for coupling to the sample collection device, to provide a second power different from the first power used to collect the sample, thereby moving the bodily fluid sample from the channel into the vessel.

In yet another embodiment described herein, a device for collecting a sample of bodily fluid from a subject, the device comprising: a device for collecting a sample from a subject from a single end of the device in contact with the subject A device for aspirating the bodily fluid sample into the device to separate the fluid sample into two separate samples; a device for transferring the fluid sample into a plurality of sample vessels, wherein the vessel provides power to separate the two The bulk of the separated sample moves from the passage into the vessel.

While the above is a complete description of the preferred embodiment as described herein, it is possible to use various alternatives, modifications and equivalents. The scope of the invention should, therefore, be determined not with reference to the above description, but should instead be determined with reference to the appended claims, along with their full scope of equivalents. Any feature, whether preferred or not, may be combined with any other feature, whether preferred or not. The appended claims should not be construed to include means-plus-function limitations, unless such limitations are expressly recited in a given claim using the phrase "means for". It should be understood that, as used throughout the description herein and the claims that follow, the meanings of "a," "an," and "the" include plural referents unless the context clearly dictates otherwise. Further, as used throughout this description and the following claims, the meaning of "in" includes "in" and "on" unless the context clearly dictates otherwise. Finally, as used throughout the description herein and the claims that follow, the meanings of "and" and "or" include both conjoint and disjunctive, and are used interchangeably unless the context clearly dictates otherwise. Thus, in contexts where the terms "and" and "or" are used, the use of such conjunctions does not exclude the meaning of "and/or" unless the context clearly dictates otherwise. The following US patent applications are hereby incorporated by reference for all purposes: 61/733,886 filed on December 5, 2012, 61/875,030 filed on September 7, 2013, and 61/875,030 filed on September 8, 2013 of 61/875,107. This document contains copyrighted material. The copyright owner (the applicant here) has no objection to the facsimile facsimile reproduction of the patent document and disclosure as it appears in the USPTO patent file or records, but otherwise reserves all copyright rights whatsoever. The following statement shall apply: Copyright 2013 Theranos Incorporated.

Claims (43)

1. A device for collecting a bodily fluid sample from a subject, the device comprising:

at least two sample collection pathways configured to draw the bodily fluid sample into the device from a single end of the device in contact with the subject, thereby separating the fluid sample into two separate samples;

a second portion comprising a plurality of sample vessels for receiving the bodily fluid sample collected in the sample collection pathway, the sample vessels being operably engageable to be in fluid communication with the sample collection pathway, whereupon when fluid communication is established, the vessels provide motive force to move a majority of the two separated samples from the pathway into the vessels.

2. A device for collecting a bodily fluid sample, the device comprising:

a first portion comprising at least one fluid collection site leading to at least two sample collection pathways configured for drawing a fluid sample therein via a first type of motive force;

a second portion comprising a plurality of sample vessels for receiving the bodily fluid sample collected in the sample collection pathway, the sample vessels being operably engageable to be in fluid communication with the sample collection pathway whereupon, when fluid communication is established, the vessels provide a second motive force different from the first motive force to move a majority of the bodily fluid sample from the pathway into the vessels;

wherein at least one of the sample collection pathways includes a fill indicator for indicating when a minimum fill level is reached and may engage at least one of the sample vessels to be in fluid communication with at least one of the sample collection pathways.

3. A device for collecting a bodily fluid sample, the device comprising:

a first portion comprising at least two sample collection channels configured to draw a fluid sample into the sample collection channels via a first type of motive force, wherein one of the sample collection channels has an internal coating designed to mix with a fluid sample and another of the sample collection channels has another internal coating that is chemically different from the internal coating;

a second portion comprising a plurality of sample vessels for receiving the bodily fluid sample collected in the sample collection channel, the sample vessels operably engageable to be in fluid communication with the collection channel, whereupon when fluid communication is established, the vessels provide a second motive force different from the first motive force to move a majority of the bodily fluid sample from the channel into the vessels;

wherein the vessels are arranged such that mixing of the fluid sample between the vessels does not occur.

4. A device for collecting a bodily fluid sample, the device comprising:

a first portion comprising a plurality of sample collection channels, wherein at least two of the channels are configured to simultaneously draw a fluid sample into each of the at least two sample collection channels via a first type of motive force;

a second portion comprising a plurality of sample vessels for receiving the bodily fluid sample collected in the sample collection channel, wherein the sample vessels have a first condition in which the sample vessels are not in fluid communication with the sample collection channel and a second condition in which the sample vessels are operably engageable to be in fluid communication with the collection channel, whereupon when fluid communication is established, the vessels provide a second motive force different from the first motive force to move the bodily fluid sample from the channel into the vessels.

5. A sample collection device, comprising:

(a) a collection channel comprising a first opening and a second opening and configured to draw a bodily fluid sample from the first opening toward the second opening via capillary action; and

(b) a sample vessel for receiving the bodily fluid sample, the vessel being engageable with the collection channel, having an interior with a vacuum therein, and having a cap configured to receive a channel;

wherein the second opening is defined by a portion of the collection channel configured to penetrate the cap of the sample vessel and provide a fluid flow path between the collection channel and the sample vessel, and

the sample vessel has an internal volume no greater than ten times an internal volume of the collection channel.

6. A sample collection device, comprising:

(a) a collection channel comprising a first opening and a second opening and configured to draw a bodily fluid sample from the first opening toward the second opening via capillary action;

(b) a sample vessel for receiving the bodily fluid sample, the vessel being engageable with the collection channel, having an interior with a vacuum therein, and having a cap configured to receive a channel; and

(c) an adapter channel configured to provide a fluid flow path between the collection channel and the sample vessel, having a first opening configured to contact the second opening of the collection channel and a second opening configured to penetrate the cap of the sample vessel.

7. A sample collection device, comprising:

(a) a body containing a collection channel comprising a first opening and a second opening and configured for drawing in bodily fluid via capillary action from the first opening toward the second opening;

(b) a base comprising a sample vessel for receiving the bodily fluid sample, the sample vessel being engageable with the collection channel, having an interior with a vacuum therein, and having a cap configured to receive a channel; and

(c) a support frame is arranged on the base plate,

wherein,

the body and the base are connected to opposite ends of the stand and are configured to be movable relative to each other such that a sample collection device is configured to have an extended state and a compressed state, wherein at least a portion of the base is closer to the body in the extended state of the device than in the compressed state,

the second opening of the collection channel is configured to penetrate the cap of the sample vessel,

in the extended state of the device, the second opening of the collection channel is not in contact with the interior of the sample vessel, and

in the compressed state of the device, the second opening of the collection channel extends through the cap of the vessel into the interior of the sample vessel, thereby providing fluid communication between the collection channel and the sample vessel.

8. A sample collection device, comprising:

(a) a body containing a collection channel comprising a first opening and a second opening and configured for drawing in bodily fluid via capillary action from the first opening toward the second opening;

(b) a base comprising a sample vessel for receiving a bodily fluid sample, the sample vessel being engageable with the collection channel, having an interior with a vacuum therein, and having a cap configured to receive a channel;

(c) a stent, and

(d) an adapter channel having a first opening and a second opening, the first opening configured to contact the second opening of the collection channel and the second opening configured to penetrate the cap of the sample vessel,

wherein the body and the base are connected to opposite ends of the support and are configured to be movable relative to each other such that the sample collection device is configured to have an extended state and a compressed state, wherein at least a portion of the base is closer to the body in the expanded state of the device than in the compressed state, in the extended state of the device, the adapter channel is not in contact with one or both of the collection channel and the interior of the sample vessel, and in the compressed state of the device the first opening of the adapter channel is in contact with the second opening of the collection channel, and the second opening of the adapter channel extends through the cap of the vessel into the interior of the sample vessel, thereby providing fluid communication between the collection channel and the sample vessel.

9. A device for collecting a fluid sample from a subject, comprising:

(a) a body containing a collection channel comprising a first opening and a second opening and configured for drawing in bodily fluid via capillary action from the first opening toward the second opening;

(b) a base engageable with the body, wherein the base supports a sample vessel engageable with the collection channel, having an interior with a vacuum therein, and having a cap configured to receive a channel;

wherein

The second opening of the collection channel is configured to penetrate the cap of the sample vessel and provide a fluid flow path between the collection channel and the sample vessel.

10. A device for collecting a fluid sample from a subject, comprising:

(a) a body containing a collection channel comprising a first opening and a second opening and configured for drawing in bodily fluid via capillary action from the first opening toward the second opening;

(b) a base engageable with the body, wherein the base supports a sample vessel engageable with the collection channel, having an interior with a vacuum therein, and having a cap configured to receive a channel; and

(c) an adapter channel having a first opening and a second opening, the first opening configured to contact the second opening of the collection channel, and the second opening configured to penetrate the cap of the sample vessel.

11. The device of any one of the preceding claims, wherein the body comprises two collection channels.

12. The device of any one of the preceding claims, wherein the interior of one or more collection channels is coated with an anticoagulant.

13. The device of claim 10, wherein the body comprises a first collection channel and a second collection channel, and an interior of the first collection channel is coated with a different anticoagulant than an interior of the second collection channel.

14. The device of claim 11, wherein the first anticoagulant is ethylenediaminetetraacetic acid (EDTA) and the second anticoagulant is different from EDTA.

15. The device of claim 11, wherein the first anticoagulant is citrate and the second anticoagulant is different from citrate.

16. The device of claim 11, wherein the first anticoagulant is heparin and the second anticoagulant is different from heparin.

17. The device of any preceding claim, wherein the body is formed from a light transmissive material.

18. The device of any one of the preceding claims, wherein the device comprises the same number of sample vessels as collection channels.

19. The device of any of claims 4, 6, or 8-14, wherein the device comprises the same number of adapter channels as collection channels.

20. The device of any one of the preceding claims, wherein the base comprises an optical indicator that provides a visual indication of whether a sample has reached the sample vessel in the base.

21. The apparatus of claim 16, wherein the base is a window that allows a user to view the vessel in the base.

22. The device of any of claims 5, 6, or 9-17, wherein the stand comprises a spring, and the spring exerts a force such that the device is in the extended state when the device is in its natural state.

23. The device of any one of the preceding claims, wherein the second opening of the collection channel or the adapter channel is covered by a sleeve, wherein the sleeve does not prevent movement of bodily fluid from the first opening toward the second opening via capillary action.

24. The device of claim 19, wherein the sleeve includes a vent hole.

25. The device of any one of the preceding claims, wherein each collection channel can accommodate a volume of no more than 500 uL.

26. The device of any one of the preceding claims, wherein each collection channel can accommodate a volume of no more than 200 uL.

27. The device of any one of the preceding claims, wherein each collection channel can accommodate a volume of no more than 100 uL.

28. A device according to any one of the preceding claims, wherein the inner perimeter of the cross-section of each collection channel is no greater than 16 mm.

29. A device according to any one of the preceding claims, wherein the inner perimeter of the cross-section of each collection channel is no greater than 8 mm.

30. A device according to any one of the preceding claims, wherein the inner perimeter of the cross-section of each collection channel is no greater than 4 mm.

31. The device of any one of the preceding claims, wherein the inner perimeter is a circumference.

32. The device of any one of the preceding claims, wherein the device comprises a first collection channel and a second collection channel, and the opening of the first channel is adjacent to the opening of the second channel, and the openings are configured for simultaneously collecting blood from a single drop of blood.

33. The device of claim 28, wherein the opening of the first channel and the opening of the second channel have a center-to-center spacing of less than or equal to about 5 mm.

34. The device of any one of the preceding claims, wherein each sample vessel has an internal volume no greater than twenty times greater than the internal volume of the collection channel with which it is engageable.

35. The device of claim 30, wherein each sample vessel has an internal volume no greater than ten times the internal volume of the collection channel with which it is engageable.

36. The device of claim 31, wherein each sample vessel has an internal volume no greater than five times greater than the internal volume of the collection channel with which it is engageable.

37. The device of claim 32, wherein each sample vessel has an internal volume no greater than twice the internal volume of the collection channel with which it is engageable.

38. The device of any one of the preceding claims, wherein establishment of fluid communication between the collection channel and the sample vessel results in transfer of at least 90% of the bodily fluid sample in the collection channel into the sample vessel.

39. The device of claim 34, wherein establishment of fluid communication between the collection channel and the sample vessel results in transfer of at least 95% of the bodily fluid sample in the collection channel into the sample vessel.

40. The device of claim 35, wherein establishment of fluid communication between the collection channel and the sample vessel results in transfer of at least 98% of the bodily fluid sample in the collection channel into the sample vessel.

41. The device of any one of the preceding claims, wherein establishment of fluid communication between the collection channel and the sample vessel results in transfer of the bodily fluid sample into the sample vessel and results in retention of no more than 10uL of bodily fluid sample in the collection channel.

42. The device of any one of claims 37, wherein establishment of fluid communication between the collection channel and the sample vessel results in transfer of the bodily fluid sample into the sample vessel and results in retention of no more than 5uL of bodily fluid sample in the collection channel.

43. The device of any one of claims 39, wherein engagement of the collection channel with the sample vessel results in transfer of the bodily fluid sample into the sample vessel and results in no more than 2uL of bodily fluid sample remaining in the collection channel.