WO2025106332A1

WO2025106332A1 - Improved sharp for insertion of analyte sensor

Info

Publication number: WO2025106332A1
Application number: PCT/US2024/054947
Authority: WO
Inventors: Yi Wang; Peter Robinson; Vivek S. RAO
Original assignee: Abbott Diabetes Care Inc
Current assignee: Abbott Diabetes Care Inc
Priority date: 2023-11-13
Filing date: 2024-11-07
Publication date: 2025-05-22
Anticipated expiration: 2026-05-13

Abstract

Systems, devices and methods for the assembly and use of an applicator and a sensor control device with an improved sharp. The improved sharp has smooth outers surfaces, and comprises an elongated main body with a distal end configured to facilitate a proximal movement of the sharp through a skin surface of a user to approximately the particular insertion depth. The improved sharp also comprises a proximal end and a channel extending from the distal end to at least the proximal end within the elongated main body. The channel is configured to support and deploy a sensor at a particular insertion depth. The improved sharp further comprises a needle that extends past the distal end of the elongated main body and facilitates an initial penetration through the skin surface of the user.

Description

IMPROVED SHARP FOR INSERTION OF ANALYTE SENSOR FIELD

[0001] The subject matter described herein relates generally to systems, devices, and methods for using an applicator to insert at least a portion of an analyte sensor in a subject.

BACKGROUND

[0002] The detection and/or monitoring of analyte levels, such as glucose, ketones, lactate, oxygen, hemoglobin A1C, or the like, can be vitally important to the health of an individual having diabetes. Patients suffering from diabetes mellitus can experience complications including loss of consciousness, cardiovascular disease, retinopathy, neuropathy, and nephropathy. Diabetics are generally required to monitor their glucose levels to ensure that they are being maintained within a clinically safe range, and may also use this information to determine if and/or when insulin is needed to reduce glucose levels in their bodies, or when additional glucose is needed to raise the level of glucose in their bodies.

[0003] Growing clinical data demonstrates a strong correlation between the frequency of glucose monitoring and glycemic control. Despite such correlation, however, many individuals diagnosed with a diabetic condition do not monitor their glucose levels as frequently as they should due to a combination of factors including convenience, testing discretion, pain associated with glucose testing, and cost.

[0004] To increase patient adherence to a plan of frequent glucose monitoring, in vivo analyte monitoring systems can be utilized, in which a sensor control device may be worn on the body of an individual who requires analyte monitoring. To increase comfort and convenience for the individual, the sensor control device may have a small form-factor, and can be assembled and applied by the individual with a sensor applicator. The application process includes inserting at least a portion of a sensor that senses a user's analyte level in a bodily fluid located in a layer of the human body, using an applicator or insertion mechanism, such that the sensor comes into contact with a bodily fluid. The sensor control device may also be configured to transmit analyte data to another device, from which the individual or her health care provider ("HCP") can review the data and make therapy decisions.

[0005] While current sensors can be convenient for users, they are also susceptible to malfunctions. These malfunctions can be caused by user error, lack of proper training, poor user coordination, overly complicated procedures, physiological responses to the inserted sensor, and other issues. Some prior art systems, for example, may rely too much on the precision assembly and deployment of a sensor control device and an applicator by the individual user. Other prior art systems may utilize sharp insertion and retraction mechanisms that are susceptible to trauma to the surrounding tissue at the sensor insertion site, which can lead to inaccurate analyte level measurements. These challenges and others described herein can lead to improper insertion and/or suboptimal analyte measurements by the sensor, and consequently, a failure to properly monitor the patient's analyte level.

[0006] Thus, a need exists for more reliable sensor insertion devices, systems and methods, that are easy to use by the patient and less prone to error.

SUMMARY

[0007] Provided herein are example embodiments of systems, devices and methods for the assembly and use of an applicator and a sensor control device with an improved sharp module. For example, some embodiments are directed to a sharp comprising an elongated main body. The elongated main body further comprises a distal end configured to facilitate a proximal movement of the sharp through a skin surface of a user to approximately the particular insertion depth, a proximal end, a channel extending from the distal end to at least the proximal end within the elongated main body, the channel being configured to support and deploy a sensor at a particular insertion depth; and smooth outer surfaces. The sharp further comprises a needle that extends past the distal end of the elongated main body and facilitates an initial penetration through the skin surface of the user. Some embodiments are directed to a sensor deployment apparatus that facilitates the insertion of the sharp into the tissue of the user. Such embodiments include a hub portion secured to the sharp. The hub, sharp, and needle can be configured according to different embodiments described herein, including (i) a metal needle, metal sharp and metal hub, (ii) a metal needle, metal sharp, and over-molded hub, (iii) a metal needle and over-molded integrally formed sharp and hub, and/or (iv) a single-shot injected molded needle, sharp, and hub module. It should be appreciated that the different embodiments related to the improved sharp module(s) can be used with any of the other applicator and/or sensor control device embodiments described herein.

[0008] Other systems, devices, methods, features and advantages of the subject matter described herein will be or will become apparent to one with skill in the art upon examination of the following figures and detailed description. It is intended that all such additional systems, devices, methods, features, and advantages be included within this description, be within the scope of the subject matter described herein, and be protected by the accompanying claims. In no way should the features of the example embodiments be construed as limiting the appended claims, absent express recitation of those features in the claims. BRIEF DESCRIPTION OF THE FIGURES

[0009] The details of the subject matter set forth herein, both as to its structure and operation, may be apparent by the study of the accompanying figures, in which like reference numerals refer to like parts. The components in the figures are not necessarily to scale, emphasis instead being placed upon illustrating the principles of the subject matter. Moreover, all illustrations are intended to convey concepts, where relative sizes, shapes and other detailed attributes may be illustrated schematically rather than literally or precisely.

[0010] FIG. 1 is a system overview of a sensor applicator, reader device, monitoring system, network, and remote system.

[0011] FIG. 2 is a block diagram depicting an example embodiment of a reader device.

[0012] FIGS. 3A to 3G are progressive views of an example embodiment of the assembly and application of the system of FIG. 1 incorporating a two-piece architecture.

[0013] FIG. 4A is a side view depicting an example embodiment of an applicator device coupled with a cap.

[0014] FIG. 4B is a side perspective view depicting an example embodiment of an applicator device and cap decoupled.

[0015] FIG. 4C is a perspective view depicting an example embodiment of a distal end of an applicator device and electronics housing.

[0016] FIG. 5 is a proximal perspective view depicting an example embodiment of a tray with sterilization lid coupled.

[0017] FIG. 6 is a proximal perspective cutaway view depicting an example embodiment of a tray with sensor delivery components.

[0018] FIG. 7A is side view depicting an example embodiment of a housing.

[0019] FIG. 7B is a perspective view depicting an example embodiment of a distal end of a housing.

[0020] FIG. 7C is a side cross-sectional view depicting an example embodiment of a housing.

[0021] FIG. 8A is a side view depicting an example embodiment of a sheath.

[0022] FIG. 8B is a perspective view depicting an example embodiment of a proximal end of a sheath.

[0023] FIG. 8C is a perspective view depicting an example embodiment of an applicator having a compressible distal end.

[0024] FIG. 8D is a cross-sectional view depicting an example embodiment of an applicator having a compressible distal end. [0025] FIG. 9A is a proximal perspective view depicting an example embodiment of a sensor electronics carrier.

[0026] FIG. 9B is a distal perspective view depicting an example embodiment of a sensor electronics carrier.

[0027] FIG. 10 is a proximal perspective view of an example embodiment of a sharp carrier.

[0028] FIG. 11 is a side cross-section depicting an example embodiment of a sharp carrier.

[0029] FIGS. 12A to 12B are top and bottom perspective views, respectively, depicting an example embodiment of a sensor module.

[0030] FIGS. 13A and 13B are perspective and compressed views, respectively, depicting an example embodiment of a sensor connector.

[0031] FIG. 14 is a perspective view depicting an example embodiment of a sensor.

[0032] FIGS. 15A and 15B are bottom and top perspective views, respectively, of an example embodiment of a sensor module assembly.

[0033] FIGS. 16A and 16B are close-up partial views of an example embodiment of a sensor module assembly.

[0034] FIG. 17A is a perspective view depicting an example embodiment of a sharp module.

[0035] FIG. 17B is a perspective view depicting another example embodiment of a sharp module.

[0036] FIGS. 17C and 17D are a side view and a perspective view depicting another example embodiment of a sharp module.

[0037] FIG. 17E is a cross-sectional view depicting an example embodiment of an applicator.

[0038] FIG. 17F is a flow diagram depicting an example embodiment method for sterilizing an applicator assembly.

[0039] FIGS. 17G and 17H are photographs depicting example embodiments of sharp tips.

[0040] FIGS. 171 and 17J are perspective views depicting example embodiments of sharp modules.

[0041] FIGS. 17K-17P depict various views of various embodiments of sharp modules that further comprise a needle.

DETAILED DESCRIPTION

[0042] Before the present subject matter is described in detail, it is to be understood that this disclosure is not limited to the particular embodiments described, as such may, of course, vary. It is also to be understood that the terminology used herein is for the purpose of describing particular embodiments only, and is not intended to be limiting, since the scope of the present disclosure will be limited only by the appended claims. [0043] As used herein and in the appended claims, the singular forms "a," "an," and "the" include plural referents unless the context clearly dictates otherwise.

[0044] The publications discussed herein are provided solely for their disclosure prior to the filing date of the present application. Nothing herein is to be construed as an admission that the present disclosure is not entitled to antedate such publication by virtue of prior disclosure. Further, the dates of publication provided may be different from the actual publication dates which may need to be independently confirmed.

[0045] Generally, embodiments of the present disclosure include systems, devices, and methods for the use of analyte sensor insertion applicators for use with in vivo analyte monitoring systems. Accordingly, many embodiments include in vivo analyte sensors structurally configured so that at least a portion of the sensor is, or can be, positioned in the body of a user to obtain information about at least one analyte of the body. It should be noted, however, that the embodiments disclosed herein can be used with in vivo analyte monitoring systems that incorporate in vitro capability, as well as purely in vitro or ex vivo analyte monitoring systems, including systems that are entirely non-invasive.

[0046] Furthermore, for each and every embodiment of a method disclosed herein, systems and devices capable of performing each of those embodiments are covered within the scope of the present disclosure. For example, embodiments of sensor control devices are disclosed and these devices can have one or more sensors, analyte monitoring circuits (e.g., an analog circuit), memories (e.g., for storing instructions), power sources, communication circuits, transmitters, receivers, processors and/or controllers (e.g., for executing instructions) that can perform any and all method steps or facilitate the execution of any and all method steps. These sensor control device embodiments can be used and can be capable of use to implement those steps performed by a sensor control device from any and all of the methods described herein.

[0047] As mentioned, a number of embodiments of systems, devices, and methods are described herein that provide for the improved assembly and use of analyte sensor insertion devices for use with in vivo analyte monitoring systems. In particular, several embodiments of the present disclosure are designed to improve the method of sensor insertion with respect to in vivo analyte monitoring systems and, in particular, to minimize trauma to an insertion site during a sensor insertion process. Some embodiments, for example, include a powered sensor insertion mechanism configured to operate at a higher, controlled speed relative to a manual insertion mechanism, in order to reduce trauma to an insertion site. In other embodiments, an applicator having a compressible distal end can stretch and flatten the skin surface at the insertion site, and consequently, can reduce the likelihood of a failed insertion as a result of skin tenting. In still other embodiments, a sharp with an offset tip, or a sharp manufactured utilizing a plastic material or a coined manufacturing process can also reduce trauma to an insertion site. In sum, these embodiments can improve the likelihood of a successful sensor insertion and reduce the amount of trauma at the insertion site, to name a few advantages.

[0048] Before describing these aspects of the embodiments in detail, however, it is first desirable to describe examples of devices that can be present within, for example, an in vivo analyte monitoring system, as well as examples of their operation, all of which can be used with the embodiments described herein.

[0049] There are various types of in vivo analyte monitoring systems. "Continuous Analyte Monitoring" systems (or "Continuous Glucose Monitoring" systems), for example, can transmit data from a sensor control device to a reader device continuously without prompting, e.g., automatically according to a schedule. "Flash Analyte Monitoring" systems (or "Flash Glucose Monitoring" systems or simply "Flash" systems), as another example, can transfer data from a sensor control device in response to a scan or request for data by a reader device, such as with a Near Field Communication (NFC) or Radio Frequency Identification (RFID) protocol. In vivo analyte monitoring systems can also operate without the need for finger stick calibration.

[0050] In vivo analyte monitoring systems can be differentiated from "in vitro" systems that contact a biological sample outside of the body (or "ex vivo") and that typically include a meter device that has a port for receiving an analyte test strip carrying bodily fluid of the user, which can be analyzed to determine the user's blood sugar level.

[0051] In vivo monitoring systems can include a sensor that, while positioned in vivo, makes contact with the bodily fluid of the user and senses the analyte levels contained therein. The sensor can be part of the sensor control device that resides on the body of the user and contains the electronics and power supply that enable and control the analyte sensing. The sensor control device, and variations thereof, can also be referred to as a "sensor control unit," an "on-body electronics" device or unit, an "on-body" device or unit, or a "sensor data communication" device or unit, to name a few.

[0052] In vivo monitoring systems can also include a device that receives sensed analyte data from the sensor control device and processes and/or displays that sensed analyte data, in any number of forms, to the user. This device, and variations thereof, can be referred to as a "handheld reader device," "reader device" (or simply a "reader"), "handheld electronics" (or simply a "handheld"), a "portable data processing" device or unit, a "data receiver," a "receiver" device or unit (or simply a "receiver"), or a "remote" device or unit, to name a few. Other devices such as personal computers have also been utilized with or incorporated into in vivo and in vitro monitoring systems.

Example Embodiment of In Vivo Analyte Monitoring System

[0053] FIG. 1 is a conceptual diagram depicting an example embodiment of an analyte monitoring system 100 that includes a sensor applicator 150, a sensor control device 102, and a reader device 120. Here, sensor applicator 150 can be used to deliver sensor control device 102 to a monitoring location on a user's skin where an analyte sensor 104 is maintained in position for a period of time by an adhesive patch 105. Sensor control device 102 is further described in FIGS. 2B and 2C, and can communicate with reader device 120 via a communication path 140 using a wired or wireless technique. Example wireless protocols include Bluetooth, Bluetooth Low Energy (BLE, BTLE, Bluetooth SMART, etc.), Near Field Communication (NFC) and others. Users can monitor applications installed in memory on reader device 120 using display 122 and input component 121, and the device battery can be recharged using power port 123. While only one reader device 120 is shown, sensor control device 102 can communicate with multiple reader devices 120. Each of the reader devices 120 can communicate and share data with one another. More details about reader device 120 is set forth with respect to FIG. 2 below. Reader device 120 can communicate with local computer system 170 via a communication path 141 using a wired or wireless communication protocol. Local computer system 170 can include one or more of a laptop, desktop, tablet, phablet, smartphone, set-top box, video game console, or other computing device and wireless communication can include any of a number of applicable wireless networking protocols including Bluetooth, Bluetooth Low Energy (BTLE), Wi-Fi or others. Local computer system 170 can communicate via communications path 143 with a network 190 similar to how reader device 120 can communicate via a communications path 142 with network 190, by a wired or wireless communication protocol as described previously. Network 190 can be any of a number of networks, such as private networks and public networks, local area or wide area networks, and so forth. A trusted computer system 180 can include a server and can provide authentication services and secured data storage and can communicate via communications path 144 with network 190 by wired or wireless technique.

Example Embodiment of Reader Device

[0054] FIG. 2 is a block diagram depicting an example embodiment of a reader device 120 configured as a smartphone. Here, reader device 120 can include a display 122, input component 121, and a processing core 206 including a communications processor 222 coupled with memory 223 and an applications processor 224 coupled with memory 225. Also included can be separate memory 230, RF transceiver 228 with antenna 229, and power supply 226 with power management module 238. Further, reader device 120 can also include a multi-functional transceiver 232 which can communicate over Wi-Fi, NFC, Bluetooth, BTLE, and GPS with an antenna 234. As understood by one of skill in the art, these components are electrically and communicatively coupled in a manner to make a functional device.

Example Embodiments of Assembly Processes for Sensor Control Device

[0055] According to some embodiments, the components of sensor control device 102 can be acquired by a user in multiple packages requiring final assembly by the user before delivery to an appropriate user location. FIGS. 3A-3E depict an example embodiment of an assembly process for sensor control device 102 by a user, including preparation of separate components before coupling the components in order to ready the sensor for delivery. In other embodiments, such as those described with respect to FIGS. 17B to 17F, components of the sensor control device 102 and applicator 150 can be acquired by a user in a single package. FIGS. 3F-3G depict an example embodiment of delivery of sensor control device 102 to an appropriate user location by selecting the appropriate delivery location and applying device 102 to the location.

[0056] FIG. 3A depicts a sensor container or tray 810 that has a removable lid 812. The user prepares the sensor tray 810 by removing the lid 812, which acts as a sterile barrier to protect the internal contents of the sensor tray 810 and otherwise maintain a sterile internal environment. Removing the lid 812exposes a platform 808 positioned within the sensor tray 810, and a plug assembly 207 (partially visible) is arranged within and otherwise strategically embedded within the platform 808. The plug assembly 207 includes a sensor module (not shown) and a sharp module (not shown). The sensor module carries the analyte sensor 104 (FIG. 1), and the sharp module carries an associated sharp used to help deliver the analyte sensor 104 transcutaneously under the user's skin during application of the sensor control device 102 (FIG. 1).

[0057] FIG. 3B depicts the sensor applicator 150 and the user preparing the sensor applicator 150 for final assembly. The sensor applicator 150 includes a housing 702 sealed at one end with an applicator cap 708. In some embodiments, for example, an O-ring or another type of sealing gasket may seal an interface between the housing 702 and the applicator cap 708. In at least one embodiment, the O-ring or sealing gasket may be molded onto one of the housing 702 and the applicator cap 708. The applicator cap 708 provides a barrier that protects the internal contents of the sensor applicator 150. In particular, the sensor applicator 150 contains an electronics housing (not shown) that retains the electrical components for the sensor control device 102 (FIG. 1), and the applicator cap 708 may or may not maintain a sterile environment for the electrical components. Preparation of the sensor applicator 150 includes uncoupling the housing 702 from the applicator cap 708, which can be accomplished by unscrewing the applicator cap 708 from the housing 702. The applicator cap 708 can then be discarded or otherwise placed aside.

[0058] FIG. 3C depicts the user inserting the sensor applicator 150 into the sensor tray 810. The sensor applicator 150 includes a sheath 704 configured to be received by the platform 808 to temporarily unlock the sheath 704 relative to the housing 702, and also temporarily unlock the platform 808 relative to the sensor tray 810. Advancing the housing 702 into the sensor tray 810 results in the plug assembly 207 (FIG. 3A) arranged within the sensor tray 810, including the sensor and sharp modules, being coupled to the electronics housing arranged within the sensor applicator 150.

[0059] In FIG. 3D, the user removes the sensor applicator 150 from the sensor tray 810by proximally retracting the housing 702 with respect to the sensor tray 810.

[0060] FIG. 3E depicts the bottom or interior of the sensor applicator 150 following removal from the sensor tray 810 (FIGS. 3A and 3C). The sensor applicator 150 is removed from the sensor tray 810 with the sensor control device 102 fully assembled therein and positioned for delivery to the target monitoring location. As illustrated, a sharp 2502 extends from the bottom of the sensor control device 102 and carries a portion of the analyte sensor 104 within a hollow or recessed portion thereof. The sharp 2502 is configured to penetrate the skin of a user and thereby place the analyte sensor 104 into contact with bodily fluid.

[0061] FIGS. 3F and 3G depict example delivery of the sensor control device 102 to a target monitoring location 221, such as the back of an arm of the user. FIG. 3Fshows the user advancing the sensor applicator 150 toward the target monitoring location 221. Upon engaging the skin at the target monitoring location 221, the sheath 704 collapses into the housing 702, which allows the sensor control device 102 (FIGS. 3E and 3G) to advance into engagement with the skin. With the help of the sharp 2502 (FIG. 3E), the analyte sensor 104 (FIG. 3E) is advanced transcutaneously into the patient's skin at the target monitoring location 221.

[0062] FIG. 3G shows the user retracting the sensor applicator 150 from the target monitoring location 221, with the sensor control device 102 successfully attached to the user's skin. The adhesive patch 105(FIG. 1) applied to the bottom of sensor control device 102 adheres to the skin to secure the sensor control device 102 in place. The sharp 2502 (FIG. 3E) is automatically retracted when the housing 702 is fully advanced at the target monitoring location 221, while the analyte sensor 104 (FIG. 3E) is left in position to measure analyte levels.

[0063] According to some embodiments, analyte monitoring system 100, as described with respect to FIGS. 3A-3G and elsewhere herein, can provide a reduced or eliminated chance of accidental breakage, permanent deformation, or incorrect assembly of applicator components compared to prior art systems. Since applicator housing 702 directly engages platform 808 while sheath 704 unlocks, rather than indirect engagement via sheath 704, relative angularity between sheath 704 and housing 702 will not result in breakage or permanent deformation of the arms or other components. The potential for relatively high forces (such as in conventional devices) during assembly will be reduced, which in turn reduces the chance of unsuccessful user assembly. Further details regarding embodiments of applicators, their components, and variants thereof, are described in U.S. Patent Publication Nos. 2013/0150691, 2016/0331283, and 2018/0235520, all of which are incorporated by reference herein in their entireties and for all purposes.

Example Embodiment of Sensor Applicator Device

[0064] FIG. 4A is a side view depicting an example embodiment of an applicator device 150 coupled with screw cap 708. This is one example of how applicator 150 is shipped to and received by a user, prior to assembly by the user with a sensor. In other embodiments, applicator 150 can be shipped to the user with the sensor and sharp contained therein. FIG. 4B is a side perspective view depicting applicator 150 and cap 708 after being decoupled. FIG. 4C is a perspective view depicting an example embodiment of a distal end of an applicator device 150 with electronics housing 706 and adhesive patch 105 removed from the position they would have retained within sensor electronics carrier 710 of sheath 704, when cap 708 is in place.

Example Embodiment of Tray and Sensor Module Assembly

[0065] FIG. 5 is a proximal perspective view depicting an example embodiment of a tray 810 with sterilization lid 812 removably coupled thereto, which, in some embodiments, may be representative of how the package is shipped to and received by a user prior to assembly.

[0066] FIG. 6 is a proximal perspective, cutaway view depicting sensor delivery components within tray 810, according to some embodiments. Platform 808 is slidably coupled within tray 810. Desiccant 502 is stationary with respect to tray 810. Sensor module 504 is mounted within tray 810.

Example Embodiment of Applicator Housing

[0067] FIG. 7A is side view depicting an example embodiment of the applicator housing 702 that can include an internal cavity with support structures for applicator function. A user can push housing 702 in a distal direction to activate the applicator assembly process and then also to cause delivery of sensor control device 102, after which the cavity of housing 702 can act as a receptacle for a sharp. In the example embodiment, various features are shown including housing orienting feature 1302 for orienting the device during assembly and use. Tamper ring groove 1304 can be a recess located around an outer circumference of housing 702, distal to a tamper ring protector 1314 and proximal to a tamper ring retainer 1306. Tamper ring groove 1304 can retain a tamper ring so users can identify whether the device has been tampered with or otherwise used. Housing threads 1310 can secure housing 702 to complimentary threads on cap 708 (FIGS. 4A and 4B) by aligning with complimentary cap threads and rotating in a clockwise or counterclockwise direction. A side grip zone 1316 of housing 702 can provide an exterior surface location where a user can grip housing 702 in order to use it. Grip overhang 1318 is a slightly raised ridge with respect to side grip zone 1316 which can aid in ease of removal of housing 702 from cap 708. A shark tooth 1320 can be a raised section with a flat side located on a clockwise edge to shear off a tamper ring (not shown), and hold tamper ring in place after a user has unscrewed cap 708 and housing 702. In the example embodiment four shark teeth 1320 are used, although more or less can be used as desired.

[0068] FIG. 7B is a perspective view depicting a distal end of housing 702. Here, three housing guide structures (or "guide ribs") 1321 are located at 120 degree angles with respect to each other, and at 60 degree angles with respect to locking structures (or "locking ribs") 1340, of which there are also three at 120 degree angles with respect to each other. Other angular orientations, either symmetric or asymmetric, can be used, as well as any number of one or more structures 1321 and 1340. Here, each structure 1321 and 1340 is configured as a planar rib, although other shapes can be used. Each guide rib 1321 includes a guide edge (also called a "sheath guide rail") 1326 that can pass along a surface of sheath 704 (e.g., guide rail 1418 described with respect to FIG. 8A). An insertion hard stop 1322 can be a flat, distally facing surface of housing guide rib 1321 located near a proximal end of housing guide rib 1321. Insertion hard stop 1322 provides a surface for a sensor electronics carrier travel limiter face 1420 of a sheath 704(FIG. 8B) to abut during use, preventing sensor electronics carrier travel limiter face 1420 from moving any further in a proximal direction. A carrier interface post 1327 passes through an aperture 1510(FIG. 9A) of sensor electronics carrier 710 during an assembly. A sensor electronics carrier interface 1328 can be a rounded, distally facing surface of housing guide ribs 1321 which interfaces with sensor electronics carrier 710.

[0069] FIG. 7C is a side cross-section depicting an example embodiment of a housing. In the example embodiment, side cross-sectional profiles of housing guide rib 1321 and locking rib 1340 are shown. Locking rib 1340 includes sheath snap lead-in feature 1330 near a distal end of locking rib 1340 which flares outward from central axis 1346 of housing 702 distally. Each sheath snap lead-in feature 1330 causes detent snap round 1404 of detent snap 1402 of sheath 704 as shown in FIG. 8C to bend inward toward central axis 1346 as sheath 704 moves towards the proximal end of housing 702. Once past a distal point of sheath snap lead-in feature 1330, detent snap 1402 of sheath 704 is locked into place in locked groove 1332. As such, detent snap 1402 cannot be easily moved in a distal direction due to a surface with a near perpendicular plane to central axis 1346, shown as detent snap flat 1406 in FIG. 8C.

[0070] As housing 702 moves further in a proximal direction toward the skin surface, and as sheath 704 advances toward the distal end of housing 702, detent snaps 1402 shift into the unlocked grooves 1334, and applicator 150 is in an "armed" position, ready for use. When the user further applies force to the proximal end of housing 702, while sheath 704 is pressed against the skin, detent snap 1402 passes over firing detent 1344. This begins a firing sequence due to release of stored energy in the deflected detent snaps 1402, which travel in a proximal direction relative to the skin surface, toward sheath stopping ramp 1338 which is slightly flared outward with respect to central axis 1346 and slows sheath 704 movement during the firing sequence. The next groove encountered by detent snap 1402 after unlocked groove 1334 is final lockout groove 1336 which detent snap 1402 enters at the end of the stroke or pushing sequence performed by the user. Final lockout recess 1336 can be a proximally-facing surface that is perpendicular to central axis 1346 which, after detent snap 1402 passes, engages a detent snap flat 1406 and prevents reuse of the device by securely holding sheath 704 in place with respect to housing 702. Insertion hard stop 1322 of housing guide rib 1321 prevents sheath 704 from advancing proximally with respect to housing 702 by engaging sensor electronics carrier travel limiter face 1420.

Example Embodiment of Applicator Sheath

[0071] FIGS. 8A and 8B are a side view and perspective view, respectively, depicting an example embodiment of sheath 704. In this example embodiment, sheath 704 can stage sensor control device 102 above a user's skin surface prior to application. Sheath 704 can also contain features that help retain a sharp in a position for proper application of a sensor, determine the force required for sensor application, and guide sheath 704 relative to housing 702 during application. Detent snaps 1402 are near a proximal end of sheath 704, described further with respect to FIG. 8C below. Sheath 704 can have a generally cylindrical cross section with a first radius in a proximal section (closer to top of figure) that is shorter than a second radius in a distal section (closer to bottom of figure). Also shown are a plurality of detent clearances 1410, three in the example embodiment. Sheath 704 can include one or more detent clearances 1410, each of which can be a cutout with room for sheath snap lead-in feature 1330 to pass distally into until a distal surface of locking rib 1340 contacts a proximal surface of detent clearance 1410.

[0072] Guide rails 1418 are disposed between sensor electronics carrier traveler limiter face 1420 at a proximal end of sheath 704 and a cutout around lock arms 1412. Each guide rail 1418 can be a channel between two ridges where the guide edge 1326 of housing guide rib 1321 can slide distally with respect to sheath 704.

[0073] Lock arms 1412 are disposed near a distal end of sheath 704 and can include an attached distal end and a free proximal end, which can include lock arm interface 1416. Lock arms 1412 can lock sensor electronics carrier 710 to sheath 704 when lock arm interface 1416 of lock arms 1412 engage lock interface 1502 of sensor electronics carrier 710. Lock arm strengthening ribs 1414 can be disposed near a central location of each lock arm 1412 and can act as a strengthening point for an otherwise weak point of each lock arm 1412 to prevent lock arm 1412 from bending excessively or breaking.

[0074] Detent snap stiffening features 1422 can be located along the distal section of detent snaps 1402 and can provide reinforcement to detent snaps 1402. Alignment notch 1424 can be a cutout near the distal end of sheath 704, which provides an opening for user alignment with sheath orientation feature of platform 808. Stiffening ribs 1426 can include buttresses, that are triangularly shaped here, which provide support for detent base 1436. Housing guide rail clearance 1428 can be a cutout for a distal surface of housing guide rib 1321 to slide during use. [0075] By way of background, those of skill the art will appreciate that skin is a highly anisotropic tissue from a biomechanical standpoint and varies largely between individuals. This can affect the degree to which communication between the underlying tissue and the surrounding environment can be performed, e.g., with respect to drug diffusion rates, the ability to penetrate skin with a sharp, or sensor insertion into the body at a sharp-guided insertion site. [0076] In particular, the embodiments described herein are directed to reducing the anisotropic nature of the skin in a predetermined area by flattening and stretching the skin, and thereby improving upon the aforementioned applications. Smoothing the skin (e.g., flattening to remove wrinkles) before mating with a similarly shaped (e.g., a flat, round adhesive pad of a sensor control unit) can produce a more consistent surface area contact interface. As the surface profile of the skin approaches the profile specifications of the designed surface of the device (or, e.g., the designed area of contact for drug delivery), the more consistent contact (or drug dosing) can be achieved. This can also be advantageous with respect to wearable adhesives by creating a continuum of adhesive-to-skin contact in a predetermined area without wrinkles. Other advantages can include (1) an increased wear duration for devices that rely on skin adhesion for functionality, and (2) a more predictable skin contact area, which would improve dosing in transcutaneous drug/pharmaceutical delivery. [0077] In addition, skin flattening (e.g., as a result of tissue compression) combined with stretching can reduce the skin's viscoelastic nature and increase its rigidity which, in turn, can increase the success rate of sharp-dependent sensor placement and functionality.

[0078] With respect to sensor insertion, puncture wounds can contribute to early signal aberration (ESA) in sensors and may be mitigated when the skin has been flattened and stretched rigid. Some known methods to minimize a puncture wound include: (1) reducing the introducers' size, or (2) limiting the length of the needle inserted into the body. However, these known methods may reduce the insertion success rate due to the compliance of the skin. For example, when a sharp tip touches the skin, before the tip penetrates the skin, the skin deforms inward into the body, a phenomenon also referred to as "skin tenting." If the sharp is not stiff enough due to a smaller cross-sectional area and/or not long enough, the sharp may fail to create an insertion point large enough, or in the desired location due to deflection, for the sensor to pass through the skin and be positioned properly. The degree of skin tenting can vary between and within subjects, meaning the distance between a sharp and a skin surface can vary between insertion instances. Reducing this variation by stretching and flattening the skin can allow for a more accurately functioning and consistent sensor insertion mechanism.

[0079] FIGS. 8C and 8D are a perspective view and a cross-sectional view, respectively, depicting an applicator 150 having a compressible distal end 1450. As shown in FIGS. 8C and 8D, applicator 150 can also include applicator housing 702, sheath 704 to which compressible distal end 1450 is attached, sharp 2502, and analyte sensor 104.

[0080] According to some embodiments, in operation, the compressible distal end 1450 of applicator is first positioned on a skin surface of the subject. The subject then applies a force on the applicator, e.g., in a distal direction, which causes compressible distal end 1450 to stretch and flatten the portion of the skin surface beneath. In some embodiments, for example, compressible distal end 1450 can be comprised of an elastomeric material and biased in a radially inward direction. In other embodiments, compressible distal end 1450 can be biased in a radially outward direction. The force on the applicator can cause an edge portion of the compressible distal end 1450 in contact with the skin surface to be displaced in a radially outward direction, creating radially outward forces on the portion of the skin surface beneath the applicator, and causing the skin surface to be stretched and flattened.

[0081] Furthermore, according to some embodiments, applying the force on the applicator also causes a medical device, such as a sensor control unit, to advance from a first position within the applicator to a second position adjacent to the skin surface. According to one aspect of some embodiments, the compressible distal end 1450 can be in an unloaded state in the first position (e.g., before the force is applied on the applicator), and a loaded state in the second position (e.g., after the force is applied on the applicator). Subsequently, the medical device is applied to the stretched and flattened portion of the skin surface beneath the compressible distal end 1450. According to some embodiments, the application of the medical device can include placing an adhesive surface 105 of a sensor control unit 102 on the skin surface and/or positioning at least a portion of an analyte sensor under the skin surface. The analyte sensor can be an in vivo analyte sensor configured to measure an analyte level in a bodily fluid of the subject. In still other embodiments, the application of the medical device can include placing a drug-loaded patch on the skin surface. Those of skill in the art will appreciate that a compressible distal end can be utilized with any of the aforementioned medical applications and is not meant to be limited to use in an applicator for analyte sensor insertion.

Example Embodiments of Sensor Electronics Carriers

[0082] FIG. 9A is a proximal perspective view depicting an example embodiment of sensor electronics carrier 710 that can retain sensor electronics within applicator 150. It can also retain sharp carrier 1102 with sharp module 2500. In this example embodiment, sensor electronics carrier 710 generally has a hollow round flat cylindrical shape, and can include one or more deflectable sharp carrier lock arms 1524 (e.g., three) extending proximally from a proximal surface surrounding a centrally located spring alignment ridge 1516 for maintaining alignment of spring 1104. Each lock arm 1524 has a detent or retention feature 1526 located at or near its proximal end. Shock lock 1534 can be a tab located on an outer circumference of sensor electronics carrier 710 extending outward and can lock sensor electronics carrier 710 for added safety prior to firing. Rotation limiter 1506 can be a proximally extending relatively short protrusion on a proximal surface of sensor electronics carrier 710 which limits rotation of carrier 710. Sharp carrier lock arms 1524 can interface with sharp carrier 1102 as described with reference to FIGS. 10 and 11 below.

[0083] FIG. 9B is a distal perspective view of sensor electronics carrier 710. Here, one or more sensor electronics retention spring arms 1518 (e.g., three) are normally biased towards the position shown and include a detent 1519 that can pass over the distal surface of electronics housing 706 of device 102 when housed within recess or cavity 1521. In certain embodiments, after sensor control device 102 has been adhered to the skin with applicator 150, the user pulls applicator 150 in a proximal direction, i.e., away from the skin. The adhesive force retains sensor control device 102 on the skin and overcomes the lateral force applied by spring arms 1518. As a result, spring arms 1518 deflect radially outwardly and disengage detents 1519 from sensor control device 102 thereby releasing sensor control device 102 from applicator 150. Example Embodiments of Sharp Carriers

[0084] FIGS. 10 and 11 are a proximal perspective view and a side cross-sectional view, respectively, depicting an example embodiment of sharp carrier 1102. Sharp carrier 1102 can grasp and retain sharp module 2500 within applicator 150. Near a distal end of sharp carrier 1102 can be anti-rotation slots 1608 which prevent sharp carrier 1102 from rotating when located within a central area of sharp carrier lock arms 1524 (as shown in FIG. 9A). Anti-rotation slots 1608 can be located between sections of sharp carrier base chamfer 1610, which can ensure full retraction of sharp carrier 1102 through sheath 704 upon retraction of sharp carrier 1102 at the end of the deployment procedure.

[0085] As shown in FIG. 11, sharp retention arms 1618 can be located in an interior of sharp carrier 1102 about a central axis and can include a sharp retention clip 1620 at a distal end of each arm 1618. Sharp retention clip 1620 can have a proximal surface which can be nearly perpendicular to the central axis and can abut a distally facing surface of sharp hub 2516 (FIG. 17A).

Example Embodiments of Sensor Modules

[0086] FIGS. 12A and 12B are a top perspective view and a bottom perspective view, respectively, depicting an example embodiment of sensor module 504. Module 504 can hold a connector 2300(FIGS. 13A and 13B) and an analyte sensor 104(FIG. 14). Module 504 is capable of being securely coupled with electronics housing 706. One or more deflectable arms or module snaps 2202 can snap into the corresponding features 2010 of housing 706. A sharp slot 2208 can provide a location for sharp tip 2502 to pass through and sharp shaft 2504 to temporarily reside. A sensor ledge 2212 can define a sensor position in a horizontal plane, prevent a sensor from lifting connector 2300 off of posts and maintain analyte sensor 104 parallel to a plane of connector seals. It can also define sensor bend geometry and minimum bend radius. It can limit sensor travel in a vertical direction and prevent a tower from protruding above an electronics housing surface and define a sensor tail length below a patch surface. A sensor wall 2216 can constrain a sensor and define a sensor bend geometry and minimum bend radius.

[0087] FIGS. 13A and 13B are perspective views depicting an example embodiment of connector 2300 in an open state and a closed state, respectively. Connector 2300 can be made of silicone rubber that encapsulates compliant carbon impregnated polymer modules that serve as electrical conductive contacts 2302 between analyte sensor 104 and electrical circuitry contacts for the electronics within housing 706. The connector can also serve as a moisture barrier for analyte sensor 104 when assembled in a compressed state after transfer from a container to an applicator and after application to a user's skin. A plurality of seal surfaces 2304 can provide a watertight seal for electrical contacts and sensor contacts. One or more hinges 2208 can connect two distal and proximal portions of connector 2300.

[0088] FIG. 14 is a perspective view depicting an example embodiment of analyte sensor 104. A neck 2406 can be a zone which allows folding of the sensor, for example ninety degrees. A membrane on tail 2408 can cover an active analyte sensing element of the analyte sensor 104. Tail 2408 can be the portion of analyte sensor 104 that resides under a user's skin after insertion. A flag 2404 can contain contacts and a sealing surface. A biasing tower 2412 can be a tab that biases the tail 2408 into sharp slot 2208. A bias fulcrum 2414 can be an offshoot of biasing tower 2412 that contacts an inner surface of a needle to bias a tail into a slot. A bias adjuster 2416 can reduce a localized bending of a tail connection and prevent sensor trace damage. Contacts 2418 can electrically couple the active portion of the sensor to connector 2300. A service loop 2420 can translate an electrical path from a vertical direction ninety degrees and engage with sensor ledge 2212 (FIG. 12B).

[0089] FIGS. 15A and 15B are bottom and top perspective views, respectively, depicting an example embodiment of a sensor module assembly comprising sensor module 504, connector 2300, and analyte sensor 104. According to one aspect of the aforementioned embodiments, during or after insertion, analyte sensor 104 can be subject to axial forces pushing up in a proximal direction against analyte sensor 104 and into the sensor module 105, as shown by force, Fl, of FIG. 15A. According to some embodiments, this can result in an adverse force, F2, being applied to neck 2406 of analyte sensor 104 and, consequently, result in adverse forces, F3, being translated to service loop 2420 of analyte sensor 104. In some embodiments, for example, axial forces, Fl, can occur as a result of a sensor insertion mechanism in which the sensor is designed to push itself through the tissue, a sharp retraction mechanism during insertion, or due to a physiological reaction created by tissue surrounding analyte sensor 104 (e.g., after insertion).

[0090] FIGS. 16A and 16B are close-up partial views of an example embodiment of a sensor module assembly having certain axial stiffening features. In a general sense, the embodiments described herein are directed to mitigating the effects of axial forces on the sensor as a result of insertion and/or retraction mechanisms, or from a physiological reaction to the sensor in the body. As can be seen in FIGS. 16A and 16B, according to one aspect of the embodiments, sensor 3104 comprises a proximal portion having a hook feature 3106 configured to engage a catch feature 3506 of the sensor module 3504. In some embodiments, sensor module 3504 can also include a clearance area 3508 to allow a distal portion of sensor 3104 to swing backwards during assembly to allow for the assembly of the hook feature 3106 of sensor 3104 over and into the catch feature 3506 of sensor module 3504. [0091] According to another aspect of the embodiments, the hook and catch features 3106, 3506 operate in the following manner. Sensor 3104 includes a proximal sensor portion, coupled to sensor module 3504, as described above, and a distal sensor portion that is positioned beneath a skin surface in contact with a bodily fluid. As seen in FIGS. 16A and 16B, the proximal sensor portion includes a hook feature 3106 adjacent to the catch feature 3506 of sensor module 3504. During or after sensor insertion, one or more forces are exerted in a proximal direction along a longitudinal axis of sensor 3104. In response to the one or more forces, hook feature 3106 engages catch feature 3506 to prevent displacement of sensor 3104 in a proximal direction along the longitudinal axis.

[0092] According to another aspect of the embodiments, sensor 3104 can be assembled with sensor module 3504 in the following manner. Sensor 3104 is loaded into sensor module 3504 by displacing the proximal sensor portion in a lateral direction to bring the hook feature 3106 in proximity to the catch feature 3506 of sensor module 3504. More specifically, displacing the proximal sensor portion in a lateral direction causes the proximal sensor portion to move into clearance area 3508 of sensor module 3504.

[0093] Although FIGS. 16A and 16B depict hook feature 3106 as a part of sensor 3104, and catch feature 3506 as a part of sensor module 3504, those of skill in the art will appreciate that hook feature 3106 can instead be a part of sensor module 3504, and, likewise, catch feature 3506 can instead be a part of sensor 3106. Similarly, those of skill in the art will also recognize that other mechanisms (e.g., detent, latch, fastener, screw, etc.) implemented on sensor 3104 and sensor module 3504 to prevent axial displacement of sensor 3104 are possible and within the scope of the present disclosure.

Example Embodiments of Sharp Modules

[0094] FIG. 17A is a perspective view depicting an example embodiment of sharp module 2500 prior to assembly within sensor module 504 (FIG. 6B). Sharp 2502 can include a distal tip 2506 which can penetrate the skin while carrying sensor tail in a hollow or recess of sharp shaft 2504 to put the active surface of the sensor tail into contact with bodily fluid. A hub push cylinder 2508 can provide a surface for a sharp carrier to push during insertion. A hub small cylinder 2512 can provide a space for the extension of sharp hub contact faces 1622 (FIG. 11). A hub snap pawl locating cylinder 2514 can provide a distal-facing surface of hub snap pawl 2516 for sharp hub contact faces 1622 to abut. A hub snap pawl 2516 can include a conical surface that opens clip 1620 during installation of sharp module 2500. Further details regarding embodiments of sharp modules, sharps, their components, and variants thereof, are described in U.S. Patent Publication No. 2014/0171771, which is incorporated by reference herein in its entirety and for all purposes. [0095] FIGS. 17B, 17C, and 17D depict example embodiments of plastic sharp modules. By way of background, according to one aspect of the embodiments, a plastic sharp can be advantageous in at least two respects.

[0096] First, relative to a metallic sharp, a plastic sharp can cause reduced trauma to tissue during the insertion process into the skin. Due to their manufacturing process, e.g., chemical etching and mechanical forming, metallic sharps are typically characterized by sharp edges and burrs that can cause trauma to tissue at the insertion site. By contrast, a plastic sharp can be designed to have rounded edges and a smooth finish to reduce trauma as the sharp is positioned through tissue. Moreover, those of skill in the art will understand that reducing trauma during the insertion process can lead to reduced ESA and improve accuracy in analyte level readings soon after insertion.

[0097] Second, a plastic sharp can simplify the applicator manufacturing and assembly process. As with earlier described embodiments, certain applicators are provided to the user in two pieces: (1) an applicator containing the sharp and sensor electronics in a sensor control unit, and (2) a sensor container. This requires the user to assemble the sensor into the sensor control unit. One reason for a two-piece assembly is to allow for electron beam sterilization of the sensor to occur separately from the applicator containing the metallic sharp and the sensor electronics. Metallic sharps, e.g., sharps made of stainless steel, have a higher density relative to sharps made of polymeric or plastic materials. As a result, electron beam scatter from an electron beam striking a metallic sharp can damage the sensor electronics of the sensor control unit. By utilizing a plastic sharp, e.g., a sharp made of polymeric materials, and additional shielding features to keep the electron beam path away from the sensor electronics, the applicator and sensor can be sterilized and packaged in a single package, thereby reducing the cost to manufacture and simplifying the assembly process for the user.

[0098] Referring to FIG. 17B, a perspective view of an example embodiment of plastic sharp module 2550 is shown, and can include a hub 2562 coupled to a proximal end of the sharp, sharp shaft 2554, a sharp distal tip 2556 configured to penetrate a skin surface, and a sensor channel 2558 configured to receive at least a portion of an analyte sensor 104. Any or all of the components of sharp module 2550 can be comprised of a plastic material such as, for example, a thermoplastic material, a liquid crystal polymer (LCP), or a similar polymeric material. According to some embodiments, for example, the sharp module can comprise a polyether ether ketone material. In other embodiments, silicone or other lubricants can be applied to an external surface of the sharp module and/or incorporated into the polymer material of the sharp module, to reduce trauma caused during the insertion process. Furthermore, to reduce trauma during insertion, one or more of sharp shaft 2554, sharp distal tip 2556, or alignment feature 2568 (described below) can include filleted and/or smoothed edges.

[0099] According to some embodiments, when assembled, the distal end of the analyte sensor can be in a proximal position relative to the sharp distal tip 2556. In other embodiments, the distal end of the analyte sensor and the sharp distal tip 2556 are co-localized.

[0100] According to another aspect of some embodiments, plastic sharp module 2550can also include an alignment feature 2568 configured to prevent rotational movement along a vertical axis 2545 of sharp module 2550 during the insertion process, wherein the alignment feature 2568 can be positioned along a proximal portion of sharp shaft 2554.

[0101] FIGS. 17C and 17D are a side view and a perspective view, respectively, depicting another example embodiment of a plastic sharp module 2570. Like the embodiment described with respect to FIG. 17B, plastic sharp module 2570 can include a hub 2582 coupled to a proximal end of the sharp, a sharp shaft 2574, a sharp distal tip 2576 configured to penetrate a skin surface, and a sensor channel 2578configured to receive at least a portion of an analyte sensor 104. Any or all of the components of sharp module 2570 can be comprised of a plastic material such as, for example, a thermoplastic material, LCP, or a similar polymeric material. In some embodiments, silicone or other lubricants can be applied to an external surface of sharp module 2570 and/or incorporated into the polymer material of sharp module 2570, to reduce trauma caused during the insertion process.

[0102] According to some embodiments, sharp shaft 2574 can include a distal portion 2577 that terminates at distal tip 2576, in which at least a portion of sensor channel 2578 is disposed. Sharp shaft 2574 can also have a proximal portion 2575 that is adjacent to distal portion 2577, wherein the proximal portion 2575 is solid, partially solid, or hollow, and is coupled to hub 2582. Although FIGS. 17C and 17D depict sensor channel 2578 as being located only within distal portion 2577, those of skill in the art will understand that sensor channel 2578 can also extend through a majority of, or along the entire length of, sharp shaft 2574 (e.g., as shown in FIG. 17B), including through at least a portion of proximal portion 2575. In addition, according to another aspect of some embodiments, at least a portion of proximal portion 2575 can have a wall thickness that is greater than the wall thickness of distal portion 2577, to reduce the possibility of stress buckling of the sharp during the insertion process. According to another aspect of some embodiments, plastic sharp module 2570can include one or more ribs (not shown) adjacent to sharp hub portion 2582 to reduce the compressive load around hub 2582, and to mitigate stress buckling of the sharp during the insertion process. [0103] It should be appreciated, that in some embodiments, distal portion 2577 can comprise a bioabsorbable or bioresorbable material, wherein distal portion 2577 is configured to be inserted into the skin surface of the user and remain at approximately the desired insertion depth until the bioabsorbable or bioresorbable material is absorbed into surrounding tissue of the user, while the rest of the sharp module 2570 is removed from the skin or skin layers. In some instances, the sharp shaft 2574 is not pulled from the user until the bioabsorbable or bioresorbable material has been substantially absorbed into the tissue surrounding the insertion site. Alternatively, distal portion 2577 is configured to be detachable from proximal portion 2575, such that when the sharp shaft 2574 is pulled from the user, distal portion 2577 detaches from proximal portion 2575, and remains in the tissue until it is absorbed.

[0104] In some instances, distal portion 2577 and proximal portion 2575 both comprise a bio-absorbable or bioresorbable material, such that the sharp shaft 2574 is configured to be inserted into the skin surface of the user and remains at approximately the desired insertion depth until the bioabsorbable or bioresorbable material is absorbed into surrounding tissue of the user. In some instances, the sharp shaft 2574 is not pulled out of the skin until the bioabsorbable/bioresorbable portion or portions are absorbed. Alternatively, sharp shaft 2574 is configured to be detachable from hub 2562, such that when upward forces are exerted on the hub 2562 to remove the sharp module, the sharp shaft 2574 detaches from the hub 2562 and remains in the tissue until it is absorbed.

[0105] By utilizing a bioabsorbable or bioresorbable material, one or more portions of the sharp module are able to remain in the tissue after insertion. This reduces the trauma to the skin that is incurred when the sharp module is removed from the tissue after insertion, typically only leaving the sensor behind. Furthermore, because portions of the sharp shaft remain in the tissue until they are absorbed, the sensor may experience improved protection during and after insertion into the tissue.

[0106] FIG. 17E is a cross-sectional view depicting an example embodiment of an applicator 150 with a plastic sharp module during an electron beam sterilization process. As indicated by the rectangular area, A, an electron beam is focused on analyte sensor 104 and plastic sharp 2550 of applicator 150 during a sterilization process. According to some embodiments, a cap 708 has been secured to applicator housing 702 to seal sensor control device 102 within applicator 150. During the sterilization process, electron beam scatter, as indicated by the diagonal arrows originating from plastic sharp 2550, in the direction and path of sensor electronics 160 has been reduced because a plastic sharp 2550 has been utilized instead of a metallic sharp. Although FIG. 17E depicts a focused electron beam sterilization process, those of skill in the art will recognize that an applicator with a plastic sharp module embodiment can also be utilized during a nonfocused electron beam sterilization process.

[0107] FIG. 17F is a flow diagram depicting an example embodiment method 1100 for sterilizing an applicator assembly, according to the embodiments described above. At Step 1105, a sensor control device 102 is loaded into the applicator 150. Sensor control device 102 can include various components, including an electronics housing, a printed circuit board positioned within the electronics housing and containing processing circuitry, an analyte sensor extending from a bottom of the electronics housing, and a plastic sharp module having a plastic sharp that extends through the electronics housing. According to some embodiments, the plastic sharp can also receive the portion of the analyte sensor extending from the bottom of the electronics housing. As previously described, at Step 1110, a cap 708 is secured to the applicator housing 702 of applicator 150, thereby sealing the sensor control device 102 within applicator 150. At Step 1115, the analyte sensor 104 and plastic sharp 2550 are sterilized with radiation while sensor control device 102is positioned within applicator 150.

[0108] According to some embodiments, sensor control device 102 can also include at least one shield positioned within the electronics housing, wherein the one or more shields are configured to shield the processing circuitry from radiation during the sterilization process. In some embodiments, the shield can comprise a magnet that generates a static magnetic field to divert radiation away from the processing circuitry. In this manner, the combination of the plastic sharp module and the magnetic shields/deflectors can operate in concert to protect the sensor electronics from radiation during the sterilization process.

[0109] Another example embodiment of a sharp designed to reduce trauma during a sensor insertion and retraction process will now be described. More specifically, certain embodiments described herein are directed to sharps comprising a metallic material (e.g., stainless steel) and manufactured through a coining process. According to one aspect of the embodiments, a coined sharp can be characterized as having a sharp tip with all other edges comprising rounded edges. As previously described, metallic sharps manufactured through a chemical etching and mechanical forming process can result in sharp edges and unintended hook features. For example, FIG. 17G is a photograph depicting a metallic sharp 2502 manufactured by a chemical etching and mechanical forming process. As can be seen in FIG. 17G, metallic sharp 2502includes a sharp distal tip 2506 with a hook feature. These and other unintended transition features can result in increased trauma to tissue during a sensor insertion and retraction process. By contrast, FIG. 17H is a photograph depicting a coined sharp 2602, that is, a metallic sharp manufactured through a coining process. As can be seen in FIG. 17H, coined sharp 2602 also includes a sharp distal tip 2606. Coined sharp 2602, however, includes only smooth, rounded edges without any unintended sharp edges or transitions.

[0110] As with previously described sharp embodiments, the coined sharp 2602 embodiments described herein can also be assembled into a sharp module having a sharp portion and a hub portion. Likewise, the sharp portion comprises a sharp shaft, a sharp proximal end coupled to a distal end of the hub portion, and a sharp distal tip configured to penetrate a skin surface. According to one aspect of the embodiments, one or all of the sharp portion, the sharp shaft, and/or the sharp distal tip of a coined sharp 2602 can comprise one or more rounded edges.

[0111] Furthermore, it will be understood by those of skill in the art that the coined sharp 2602 embodiments described herein can similarly be used with any of the sensors described herein, including in vivo analyte sensors that are configured to measure an analyte level in a bodily fluid of a subject. For example, in some embodiments, coined sharp 2602 can include a sensor channel (not shown) configured to receive at least a portion of an analyte sensor. Likewise, in some embodiments of the sharp module assembly utilizing a coined sharp 2602, the distal end of the analyte sensor can be in a proximal position relative to the sharp distal tip 2606. In other embodiments, the distal end of the analyte sensor and the sharp distal tip 2606 are co-localized. [0112] Other example embodiments of sharps designed to reduce trauma during a sensor insertion process will now be described. Referring back to FIG. 17A, an example embodiment of sharp module 2500 (shown without analyte sensor) is depicted, and includes a sharp 2502 comprising a sensor channel having a U-shaped geometry configured to receive at least a portion of an analyte sensor, and a distal tip 2506 configured to penetrate a skin surface during the sensor insertion process.

[0113] In certain embodiments, sharp module can include a sharp having a distal tip with an offset geometry configured to create a smaller opening in the skin relative to other sharps (e.g., sharp 2502 depicted in FIG. 17A). Turning to FIG. 171, a perspective view of an example embodiment of a sharp module 2620 (with the analyte sensor 104) having an offset tip portion is shown. Similar to the previously described sharp modules, sharp module 2620 can include a sharp shaft 2624 coupled to hub 2632 at a proximal end, sensor channel 2628 configured to receive at least a portion of analyte sensor 104, and a distal tip 2626configured to penetrate a skin surface during the sensor insertion process.

[0114] According to one aspect of the embodiment, one or more sidewalls 2629 that form sensor channel 2628 are disposed along sharp shaft 2624 at a predetermined distance, Dsc, from distal tip 2626. In certain embodiments, predetermined distance, Dsc, can be between 1 mm and 8 mm. In other embodiments, predetermined distance, Dsc, can be between 2 mm and 5 mm. Those of skill in the art will recognize that other predetermined distances, Dsc, can be utilized and are fully within the scope of the present disclosure. In other words, according to some embodiments, sensor channel 2628 is in a spaced relation to distal tip 2626. In this regard, distal tip 2626 has a reduced cross-sectional footprint relative to, for example, distal tip 2506 of sharp module 2500, whose sensor channel is adjacent to distal tip 2506. According to another aspect of the embodiment, at the terminus of distal tip 2626 is an offset tip portion 2627 configured to prevent sensor tip 2408 from being damaged during insertion and to create a small opening in the skin. In some embodiments, offset tip portion 2627 can be a separate element coupled to a distal end of sharp shaft 2624. In other embodiments, offset tip portion 2627 can be formed from a portion of distal tip 2506 or sharp shaft 2624. During insertion, as the sharp moves into the skin surface, offset tip portion 2627can cause the skin surrounding the skin opening to stretch and widen in a lateral direction without further cutting of skin tissue. In this regard, less trauma results during the sensor insertion process.

[0115] Referring next to FIG. 17J, a perspective view of another example embodiment of a sharp module 2640 (with analyte sensor 104) having an offset tip portion is shown. Like the previous embodiments, sharp module 2640 can include a sharp shaft 2644 coupled to hub 2652 at a proximal end, sensor channel 2648 configured to receive at least a portion of analyte sensor 104, and a distal tip 2646 configured to penetrate a skin surface during the sensor insertion process. According to one aspect of the embodiment, sensor channel 2648 can comprise a first sidewall 2649 a and a second sidewall 2649 b, wherein first sidewall 2649 a extends to the distal tip 2646, wherein a terminus of first sidewall 2649 a forms the offset tip portion 2647, and wherein second sidewall 2649 b is disposed along sharp shaft 2644 at a predetermined distance from distal tip 2646, and wherein a terminus of second sidewall 2649 b is proximal to the terminus of first sidewall 2649 a. Those of skill in the art will appreciate that in other embodiments, second sidewall 2649 b can extend to the distal tip 2646 to form the offset tip portion 2647, instead of first sidewall 2649 a. In addition, offset tip portion 2647 can be formed from a third or fourth sidewall (not shown), and such geometries are fully within the scope of the present disclosure.

[0116] Attention will now be directed to Figs. 17K - 17P, which illustrates different embodiments of a sharp module comprising a sharp shaft and a needle. As shown in Fig. 17K- 17M, various embodiments are directed to different sharp modules comprising a metallic sharp shaft and metallic needle. As shown in Fig. 17N, some embodiments are directed to sharp modules comprising a single-shot injection molded sharp shaft, needle, and hub. As shown in Fig. 170, some embodiments are directed to sharp modules comprising a metallic needle with an over-molded hub and sharp shaft. As shown in Fig. 17P, additional embodiments are directed to alternate sharp modules comprising a single-shot injection molded needle, sharp shaft, and hub. [0117] It should be appreciated that needle(s) described in the embodiments presented below can be configured according to different variations. The needle is an integral component of the following sharp modules, designed to facilitate an initial breaking through the skin surface of the user. This initial penetration by the needle aids in the subsequent insertion of the sharp to the desired depth and reduces the trauma to the skin. The needle is configured in such a way that it can easily penetrate the skin surface, providing a pathway for the sharp to follow. This configuration is a result of careful design and selection of materials, ensuring that the needle is both strong enough to penetrate the skin surface and retain shape as the sharp is inserted to the desired depth and then removed. By reducing trauma to the skin, the user of the applicator device experiences a more comfortable insertion process. Additionally, by reducing trauma to the skin, the sensor that is deployed is able to begin reading analyte levels more accurately and in a faster time frame, than sensors that are deployed into traumatized skin tissue that must heal before being able to provide accurate analyte readings.

[0118] The needle can be made from a variety of materials, depending on the specific requirements of the sharp. In some cases, the needle may be made from a metal material. Metal materials are often chosen for their strength and durability, making them suitable for the task of penetrating the skin surface. One such metal material that may be used is stainless steel. Stainless steel is a suitable material due to its resistance to corrosion and its strength, as well as being able to be sterilized/remain sterilized easily. In embodiments where the needle is injection molded with other components of the sharp module, the needle comprises a micro-moldable material. [0119] The micro-moldable material can be composed of various substances. In some cases, the micro-moldable material may be a plastic material, polymer material, and/or polycarbonate material. Plastic materials are often chosen for their versatility and ease of molding, making them suitable for the formation of the sharp. The plastic material can be a biocompatible plastic, ensuring that the sharp is safe for use on or in the human body. Specific types of plastic that may be used include polystyrene (PS), polypropylene (PP), polyvinyl chloride (PVC), polyethylene (PE), polyurethane (PU), polycarbonate (PC), polyethylene terephthalate (PET), or polyetheretherketone (PEEK).

[0120] The type of needle used can also vary, depending on the specific application of the sharp. In some cases, the needle may be a hypodermic needle. Hypodermic needles are commonly used in medical applications and are designed to deliver substances under the skin. In other cases, the needle may be an acupuncture needle. Acupuncture needles are typically thinner and can be more flexible than hypodermic needles, making them suitable for applications that require a high degree of precision and control.

[0121] The diameter of the needle is another factor that can vary, depending on the specific requirements of the sharp. In some cases, the needle may have a diameter between ,4mm and 1.8mm. This range of diameters allows for a variety of applications, including performing precise, controlled insertions. In other cases, the needle may have a diameter between ,1mm and ,35mm. This smaller range of diameters may initially facilitate reduced trauma to the skin.

[0122] Fig. 17K is a perspective view depicting an example embodiment of sharp module

2700 without a hub and prior to assembly within a sensor module (e.g., sensor module 504). Sharp 2702 can include a distal tip 2706 that forms an end of the sharp that can penetrate the skin while carrying a sensor in a channel (i.e., hollow or recess) of sharp shaft 1704 in order to put the active surface of the sensor tail into contact with bodily fluid. Sharp module 1700 further comprises a needle 2718 that is disposed adjacent to sharp 2702, with a distal end of the needle 2718 extending past the distal end 2706 of the sharp 2702. In some instances, sharp 2702 comprises a metal material, such as stainless steel, that has been punched and formed to create the channel of sharp shaft 2704, while the hub components are comprised of a polycarbonate that has been over-molded over the sharp 2702 and needle 2718.

[0123] Fig. 17L is a perspective view depicting an example embodiment of sharp module

2701 (e.g., sharp module 2700 with a hub and prior to assembly within a sensor module). As shown in Fig. 17L, sharp module 2701 comprises a hub push cylinder 2708 can provide a surface for a sharp carrier to push during insertion. A hub small cylinder 2712 can provide a space for the extension of sharp hub contact faces (e.g., sharp hub contact faces 1622). A hub snap pawl locating cylinder 2714 can provide a distal-facing surface of the hub snap pawl 2716 for sharp hub contact faces to abut. The hub snap pawl 2716 can include a conical surface that opens a clip (e.g., clip 1620) during the installation of sharp module 2701. As shown in Fig. 17L, hub portion 2720 is over-molded over the needle and is configured to secure and support an end (opposite to the distal end of the needle) of the needle 2718.

[0124] In some instances, the needle 2718, as shown in Figs. 17K-17L, is disposed at an angle that is off-set from a central axis of the sharp 2702. In other instances, the needle 2718 is disposed parallel to the central axis of the sharp 2702. Additionally, or alternatively, the needle 2718 can extend directly from the distal end 2706 of sharp 2702. It should also be appreciated that while distal end 2706 is shown to be forming a square shape, the walls of the sharp 2702 are sharp and can facilitate penetration and insertion into the skin. However, in some embodiments, to further reduce trauma to the skin, the distal end 2706 of sharp 2702 can be formed into a point (i.e., a conical or pyramidal point).

[0125] As described above, by providing a needle as part of sharp module 2700/2701, the needle is able to facilitate an initial penetration of the skin creating a pathway into which the distal end 2706 of the sharp 2702 and subsequent body of the sharp 2702 can be inserted. Because the needle 2718 comprises a sharp pointed tip and small diameter, the needle 2718 is more easily able to pierce the surface and underlying layers of the skin than the sharp 2702. Additionally, because of the aforementioned attributes of the needle 2718, the needle 2718 is able to pierce the skin with reduced trauma to the skin. And, because a pathway has been initiated by the needle 2718, the subsequent insertion of the sharp 2702 also causes reduced trauma to the skin.

[0126] Attention will now be directed to Fig. 17M which illustrates an alternate embodiment of a sharp module comprising a metal sharp, metal needle, and over-molded hub. For example, Fig. 17M illustrates a perspective view of an example embodiment of sharp module 2730 that comprises a (i) sharp 2732 with distal end 2736 and sharp shaft 2734 and (ii) needle 2748. Like sharp module 2700/2701, the sharp 2732 is punched and formed from a metal, such as stainless steel. The needle 2748 also comprises a metallic material, such as stainless steel. As shown in Fig. 17M, the hub is only over-molded over the sharp 2732 and not the needle 2748. Instead, here, the needle 2748 is welded to an outer sidewall of the sharp 2732. This embodiment reduces the material and size needed for the hub and reduces the amount of over-molding required. Welding the needle 2748 to the sharp 2732 provides a secure attachment to the sharp 2732, such that the sharp 2732 can provide support to the needle 2748 during insertion into the skin.

[0127] As shown in Fig. 17M, the over-molded hub comprises a hub push cylinder 2738 that can provide a surface for a sharp carrier to push during insertion. The hub also comprises a hub small cylinder 2742 can provide a space for the extension of sharp hub contact faces (e.g., sharp hub contact faces 1622). A hub snap pawl locating cylinder 2744 can provide a distal-facing surface of the hub snap pawl 2746 for sharp hub contact faces to abut. The hub snap pawl 2746 can include a conical surface that opens a clip (e.g., clip 1620) during the installation of sharp module 2730.

[0128] Attention will now be directed to Fig. 17N, which illustrates a perspective view of a single-shot injection molded sharp module 2750. For example, sharp module 2750 comprises a hub 2762 coupled to a proximal end of the sharp, sharp shaft 2754, and a sharp distal tip 2756 configured to penetrate a skin surface. The sharp shaft 2754 further comprises a sensor channel 2759 configured to receive at least a portion of analyte sensor (e.g., analyte sensor 104). Sharp module 2750 is characterized by comprising components comprised of a plastic material, such as a thermoplastic material, a liquid crystal polymer (LCP), or a similar polymeric material. Similar to the sharp module in Fig. 17B, to further reduce trauma during insertion, one or more of sharp shaft 2754 or sharp distal tip 2756 can include filleted and/or smoothed edges. Because sharp module 2750 is a single-shot injection molded device, the components of the sharp module are formed integrally with one another. By forming the sharp shaft 2754 and needle 2768 in a plasticbased material, the manufacturing time and expense are both greatly reduced because of the ability to perform single-shot injection molding.

[0129] Sharp module 2750 also achieves similar technical benefits as other sharp module embodiments that utilize needles to initiate penetration into the skin. As shown in Fig. 17N, injection molded needle 2768 extends from sharp distal end 2756 to cause a first penetration of the skin and form an initial pathway through the skin into which the sharp shaft 2754 can be inserted, reducing trauma to the skin. In some instances, as shown in Fig. 17N, needle 2768 extends from sharp distal end 2756 (e.g., from a particular side-wall of the sharp shaft 2754) at an angle that is off-set from a central axis of the sharp shaft 2754. In other embodiments, needle 2768 extends from sharp shaft 2754 at an angle parallel to the central axis (either adjacent to the central axis, like extending from a side-wall, or along the central axis, for example, extending from a central point of the sharp distal end 2756).

[0130] In some instances, the sharp module 2750 is micro-molded in the axial direction. This beneficially provides smoother surfaces of the components of the sharp module, particularly in the hub. Because of the axial direction of the micro-molding, the hub is prevented from forming protruding artifacts. By preventing such artifacts on the surface(s) of the hub, sharp module housing (such as other applicator systems and components described herein) are able to make better seals with the hub, allowing the sharp module to be better protected and achieve a longer shelf life while remaining hermetically sealed.

[0131] Attention will now be directed to Fig. 170, which illustrates a perspective view of an example embodiment of a sharp module comprising an injection molded hub and sharp overmolded with a metal needle. For example, as shown in Fig. 170, sharp module 2770 comprises a molded hub 2782 and molded sharp shaft 2774. The molded sharp shaft 2774 forms a shaft channel 2778 ending at distal end 2776. The sharp module 2770 further comprises a needle 2788 that comprises a metal material. In some instances, needle 2788 is an insert within a sharp shaft 2774 that is an over-molded sharp shaft. Because the sharp shaft and hub have been integrally formed during the injection molding process, there is no leak path requiring an additional sealant. [0132] Attention will now be directed to Fig. 17P, which illustrates a perspective view of an alternate example embodiment of single-shot injection molded sharp module. For example, as shown in Fig. 17P, sharp module 2790 is a fully injection molded sharp module comprising a plastic-based material. Sharp module 2790 comprises hub 2802, sharp shaft 2794 forming distal end 2796 and sensor channel 2796. Sharp module 2790 also comprises needle 2808, which has been integrally formed with the sharp shaft 2794 and hub 2802 and extends from distal end 2796. [0133] It should be appreciated, that in any of the aforementioned sharp module embodiments comprising a needle, the needle and/or other portions of the sharp module may comprise a bioabsorbable or bioresorbable material. For example, in some instances, the needle comprises a bio-absorbable material, such that after insertion, the needle remains in the tissue until it is absorbed. In such instances, the sharp module is either not removed until the needle (or portion of the needle) is absorbed or the needle (or portion of the needle) is detachable such that when the sharp module is removed, the needle (or bio-absorbable portion of the needle) is detached from the rest of the sharp module. In such embodiments, portions of the sharp shaft may also comprise a bio-absorbable material (as described in more detail in reference to Figs. 17C-17D).

[0134] It should also be appreciated that any of the aforementioned sharp module embodiments with needles can also include one or more additional features described herein, such as an alignment feature, an external lubricant, a material slip agent, or another component or manufacturing feature that provides additional technical benefits described herein.

[0135] For example, regarding the alignment feature, in some instances, the elongated main body of the sharp may include an alignment feature. This alignment feature is disposed along a portion of a base surface of the elongated main body. The alignment feature is designed to guide the sharp during insertion, ensuring that it is inserted at the correct angle and direction. This is particularly beneficial in applications where precision is paramount, such as in medical procedures or in the deployment of sensors at a specific depth within the skin surface of the user. The alignment feature aids in the accurate positioning of the sharp, contributing to the overall effectiveness of the device.

[0136] In some instances, the alignment feature is integrally formed with the elongated main body. This means that the alignment feature and the main body are formed as a single, continuous piece, without any joints or connections between them. This integral formation contributes to the strength and stability of the sharp, ensuring that it can withstand the forces exerted on it during insertion into the skin surface of the user. [0137] The design and configuration of the alignment feature can be tailored to the specific requirements of the sharp. Factors such as the intended insertion depth, the type of sensor to be deployed, and the specific application of the sharp can all influence the design of the alignment feature.

[0138] Regarding the external lubricant, the sharp may also include an external lubricant applied to the smooth outer surfaces. This lubricant serves to further reduce friction during the insertion process, enhancing the comfort and ease of use for the user. The lubricant can be any suitable substance known in the art that reduces friction without adversely affecting the user or the functionality of the sharp. The choice of lubricant can be tailored to different embodiments of the sharp, taking into account factors such as the material of the sharp, the intended insertion depth, and the specific application of the sharp. The lubricant is applied to the smooth outer surfaces of the sharp, covering the elongated main body and the tip. This ensures that the sharp can move smoothly through the skin surface of the user, reducing discomfort and facilitating a precise and controlled insertion. The lubricant may be applied to either metallic or plastic-based materials.

[0139] Regarding the slip agents, in addition to the base material, the micro-moldable material may also include various additives. One such additive is a slip additive, which is configured to reduce a friction coefficient associated with the micro-moldable material. This reduction in friction can aid in the insertion of the sharp into the skin surface of the user, making the process more comfortable and efficient. The slip additive may include one or more fatty acid amides, which are known for their lubricating properties.

[0140] Additionally, it should be appreciated that other configurations of different sharp module components described herein may also be used in combination with any of the embodiments depicted in Figs. 17K-17P. For example, the dimensions of the hub, sharp/sharp shaft, sensor channel, and needle may be tailored to specific use cases and applicator systems. [0141] For example, in some instances, the sensor channel of the sharp extends from the distal end to at least the proximal end within the elongated main body, or alternatively along any length or portion of the sharp terminating in the distal end of the sharp. The channel is specifically configured to support and deploy a sensor at a particular insertion depth. This means that the channel is not just a hollow space within the main body, but a functional part of the sharp that plays a role in its operation. The sensor, when deployed, can provide valuable data or perform a specific function, depending on the design and purpose of the sharp.

[0142] The configuration of the channel can vary, depending on the specific requirements of the sharp. In some cases, the channel may be partially open along a top portion of the elongated main body. This configuration allows for easy access to the channel and facilitates the deployment of the sensor. In other cases, the channel may form a u-shaped hollow channel within the elongated main body. This u-shaped configuration provides a secure and stable set of sidewalls that provide support for the sensor, ensuring that it remains in place during the insertion and operation of the sharp.

[0143] In yet other cases, the channel may form a cylindrical hollow space within the elongated main body. This cylindrical configuration provides a large volume for the sensor, allowing for the deployment of larger or multiple sensors. Regardless of the specific configuration, the channel is designed to support and deploy a sensor at a particular insertion depth, providing a level of control and precision that is beneficial in many applications.

[0144] The dimensions of the sharp, including its length and the diameter of the elongated main body, are factors that can be tailored to the specific requirements of the sharp's application. The length of the sharp can vary, depending on the desired insertion depth and the specific function of the sharp. In some cases, the sharp may have a length between 1.5mm and 25mm. This range of lengths allows for a variety of applications, from shallow insertions to deeper penetrations into the skin surface of the user.

[0145] The diameter of the elongated main body is another dimension that can be adjusted according to the specific requirements of the sharp. The diameter of the main body can influence the size of the channel within the main body, as well as the overall size and profile of the sharp. In some cases, the elongated main body may have a diameter between 0.1mm and 0.5mm.

[0146] The choice of dimensions for the sharp, including its length and the diameter of the elongated main body, can be influenced by a variety of factors. These factors may include the intended insertion depth, the type and size of sensor to be deployed, the specific application of the sharp, and the material properties of the micro-moldable material. By adjusting these dimensions, the sharp can be tailored to meet the specific requirements of its application, ensuring that it performs its function effectively and efficiently.

[0147] Furthermore, it will be understood by those of skill in the art that any of the sharp and/or sharp module embodiments described herein can be used or combined with any of the sensors, sensor modules, sensor electronics carriers, sheaths, applicator devices, or any of the other analyte monitoring system components described herein.

[0148] Alternatively or in addition to the other examples described herein, examples include any combination of the following:

[0149] Clause 1. A sharp comprising: an elongated main body comprising: a distal end configured to facilitate a proximal movement of the sharp through a skin surface of a user to approximately a particular insertion depth; a proximal end; a channel extending from the distal end to at least the proximal end within the elongated main body, the channel being configured to support and deploy a sensor at the particular insertion depth; and smooth outer surfaces; and a needle that extends past the distal end of the elongated main body and facilitates an initial penetration through the skin surface of the user.

[0150] Clause 2. The sharp of clause 1, wherein the needle comprises a metal material.

[0151] Clause 3. The sharp of clause 1, wherein the metal material is stainless steel.

[0152] Clause 4. The sharp of clause 1, wherein the elongated main body comprises a metal material.

[0153] Clause 5. The sharp of any of clauses 1-4, wherein the needle comprises a diameter between ,4mm and 1.8mm.

[0154] Clause 6. The sharp of any of clauses 1-3, wherein the elongated main body comprises a micro-moldable material that is over-molded with respect to the needle.

[0155] Clause 7. The sharp of clause 1, wherein the elongated main body and the needle comprise a micro-moldable material, wherein the sharp is formed from a single-shot injection molding process.

[0156] Clause 8. The sharp of any of clauses 6-7, wherein the micro-moldable material further comprises a slip additive configured to reduce a friction coefficient associated with the micro- moldable material.

[0157] Clause 9. The sharp of clause 8, wherein the slip additive comprises one or more fatty acid amides.

[0158] Clause 10. The sharp of any of clauses 1-9, further comprising an external lubricant applied to the smooth outer surfaces of the sharp.

[0159] Clause 11. The sharp of any of clauses 6-10, wherein the sharp is formed from micromolding the micro-moldable material in an axial direction.

[0160] Clause 12. The sharp of any of clauses 1-11, wherein the channel is a partially open channel along a top portion of the elongated main body.

[0161] Clause 13. The sharp of clause 12, wherein the elongated main body comprises a rounded base and two opposing side walls extending upward from the rounded base, forming a u-shaped hollow channel within the elongated main body.

[0162] Clause 14. The sharp of any of clauses 1-13, wherein the elongated main body is cylindrical, and the channel forms a cylindrical hollow space within the elongated main body.

[0163] Clause 15. The sharp of clause 14, wherein the channel extends from the proximal end of the sharp to the distal end of the sharp. [0164] Clause 16. The sharp of any of clauses 1-15, the distal end further comprising a needle partially disposed within the distal end of the sharp such that the needle extends from the distal end.

[0165] Clause 17. The sharp of clause 1, wherein the needle is integrally formed with the elongated main body.

[0166] Clause 18. The sharp of any of clauses 1 or 17, wherein the micro-moldable material is a plastic material.

[0167] Clause 19. The sharp of any of clause 18, wherein the plastic material is a biocompatible plastic.

[0168] Clause 20. The sharp of clause 19, wherein the plastic material comprises one of: polystyrene (PS), polypropylene (PP), polyvinyl chloride (PVC), polyethylene (PE), polyurethane (PU), polycarbonate (PC), polyethylene terephthalate (PET), or polyetheretherketone (PEEK).

[0169] Clause 21. The sharp of any of clauses 17-20, wherein the elongated main body comprises a first material and the needle comprises a second material having a greater stiffness than the first material.

[0170] Clause 22. The sharp of any of clauses 17-21, wherein the sharp is formed from a bioabsorbable material, such that the sharp is configured to be inserted into the skin surface of the user and remain at approximately the particular insertion depth until the bioabsorbable material is absorbed into surrounding tissue of the user.

[0171] Clause 23. The sharp of any of clauses 1-22, wherein the sharp comprises a length between 1.5mm and 25mm.

[0172] Clause 24. The sharp of any of clauses 1-23, wherein the elongated main body comprises a diameter between 0.1mm and 0.5mm.

[0173] Clause 25. The sharp of any of clauses 1-24, wherein the elongated main body further comprises an alignment feature disposed along a portion of a base surface of the elongated main body.

[0174] Clause 26. The sharp of clause 25, wherein the alignment feature is integrally formed with the elongated main body.

[0175] Clause 27. The sharp of any of clauses 1-26, wherein the distal end comprises a conical shape such that the point is a conical point.

[0176] Clause 28. The sharp of any of clauses 1-26, wherein the distal end comprises a pyramidal shape such that the point is an apex of the pyramidal shape.

[0177] Clause 29. The sharp of clause 28, wherein an inner surface of the channel extends into a flat surface of the distal end. [0178] Clause 30. The sharp of clauses 13 and 29, wherein proximal ends of the two opposing side walls slope downward to the flat surface of the distal end.

[0179] Clause 31. A sensor deployment apparatus comprising: a hub; and a sharp integrally formed with the hub, the sharp comprising: an elongated main body comprising: a channel extending from a distal end of the elongated main body to at least a proximal end of the elongated main body, the channel being configured to support and deploy a sensor at a particular insertion depth; and a needle configured to facilitate an initial penetration through a skin surface of a user.

[0180] Clause 32. The sensor deployment apparatus of clause 31, wherein the needle and hub are integrally formed with the elongated main body of the sharp.

[0181] Clause 33. The sensor deployment apparatus of any of clauses 31-32, wherein the sharp and the hub comprise a plastic material.

[0182] Clause 34. The sensor deployment apparatus of any of clause 33, wherein the plastic material is a biocompatible plastic.

[0183] Clause 35. The sensor deployment apparatus of clause 34, wherein the plastic material comprises one of: polystyrene (PS), polypropylene (PP), polyvinyl chloride (PVC), polyethylene (PE), polyurethane (PU), polycarbonate (PC), polyethylene terephthalate (PET), or polyetheretherketone (PEEK).

[0184] Clause 36. The sensor deployment apparatus of any of clauses 31-35, wherein the elongated main body comprises a first material and the hub comprises a second material having a lesser stiffness than the first material.

[0185] Clause 37. The sensor deployment apparatus of any of clauses 31-36, wherein the sharp is formed from a bioabsorbable material, such that the sharp is configured to be inserted into the skin surface of the user and remain at approximately the particular insertion depth until the bioabsorbable material is absorbed into surrounding tissue of the user.

[0186] Clause 38. The sensor deployment apparatus of clause 37, wherein the sharp is detachable from the hub after insertion into the skin surface of the user.

[0187] Clause 39. The sensor deployment apparatus of any of clauses 31-38, wherein the sensor deployment apparatus comprises a micro-moldable material.

[0188] Clause 40. The sensor deployment apparatus of any of clauses 33-39, wherein the sensor deployment apparatus further comprises a slip additive configured to reduce a friction coefficient associated with an outer surface of the sensor deployment apparatus.

[0189] Clause 41. The sensor deployment apparatus of clause 40, wherein the slip additive comprises one or more fatty acid amides. [0190] Clause 42. The sensor deployment apparatus of any of clauses 31-41, further comprising an external lubricant applied to an outer surface of the sharp.

[0191] Clause 43. The sensor deployment apparatus of any of clauses 39-42, wherein the sensor deployment apparatus is formed from micro-molding the micro-moldable material in an axial direction.

[0192] Clause 44. The sensor deployment apparatus of any of clauses 31-43, wherein the channel is a partially open channel along a top portion of the elongated main body.

[0193] Clause 45. The sensor deployment apparatus of clause 44, wherein the elongated main body comprises a rounded base and two opposing side walls extending upward from the rounded base, forming a u-shaped hollow channel within the elongated main body.

[0194] Clause 46. The sensor deployment apparatus of clause 45, wherein the channel extends from a base portion of the hub to at least the proximal end of the elongated main body. [0195] Clause 47. The sensor deployment apparatus of clause 45, wherein the channel extends from a base portion of the hub to the distal end of the sharp.

[0196] Clause 48. The sensor deployment apparatus of any of clauses 31-43, wherein the elongated main body is cylindrical, and the channel comprises an enclosed cylindrical hollow space within the elongated main body.

[0197] Clause 49. The sensor deployment apparatus of clause 48, wherein the channel extends from the proximal end of the sharp to the distal end of the sharp.

[0198] Clause 50. The sensor deployment apparatus of clause 48, wherein the channel extends from a distal end of the hub to the proximal end of the elongated main body.

[0199] Clause 51. The sensor deployment apparatus of claim of clause 48, wherein the channel extends from a distal end of the hub to the distal end of the sharp.

[0200] Clause 52. The sensor deployment apparatus of any of clauses 31-51, the distal end further comprising a needle partially disposed within the distal end of the sharp such that the needle extends from the distal end of the sharp.

[0201] Clause 53. The sensor deployment apparatus of clause 52, wherein the needle comprises a metal material.

[0202] Clause 54. The sensor deployment apparatus of clause 53, wherein the metal material is stainless steel.

[0203] Clause 55. The sensor deployment apparatus of clause 52, wherein the needle is hypodermic needle.

[0204] Clause 56. The sensor deployment apparatus of any of clauses 52-55, wherein the needle comprises a diameter between ,4mm and 1.8mm. [0205] Clause 57. The sensor deployment apparatus of clause 56, wherein the needle is an acupuncture needle.

[0206] Clause 58. The sensor deployment apparatus of any of clauses 52-55, wherein the needle comprises a diameter between ,1mm and ,35mm.

[0207] Clause 59. The sensor deployment apparatus of any of clauses 31-58, wherein the elongated main body further comprises an alignment feature disposed along a portion of a base surface of the elongated main body.

[0208] Clause 60. The sensor deployment apparatus of clause 59, wherein the alignment feature is integrally formed with the elongated main body.

[0209] Clause 61. The sensor deployment apparatus of any of clauses 31-60, wherein the distal end of the sharp comprises a conical shape such that the point is a conical point.

[0210] Clause 62. The sensor deployment apparatus of any of clauses 31-60, wherein a distal end of the sharp comprises a pyramidal shape such that the point is an apex of the pyramidal shape.

[0211] Clause 63. The sensor deployment apparatus of any of clauses 61-62, wherein an inner surface of the channel extends into a flat surface of the distal end.

[0212] Clause 64. The sensor deployment apparatus of any of clauses 31-60, wherein the distal end is of the sharp comprises a rounded point.

[0213] Clause 65. The sensor deployment apparatus of any of clauses 31-64, wherein the sensor deployment apparatus comprises a central axis; and wherein the point of the sharp lies along the central axis.

[0214] Clause 66. A sensor deployment system comprising: a sensor; a sensor deployment apparatus comprising: a sharp comprising: an elongated main body comprising: a channel extending from a distal end of the elongated main body to at least a proximal end of the elongated main body, the channel being configured to support and deploy the sensor at a particular insertion depth under a skin surface of a user; and a needle configured to facilitate an initial penetration through the skin surface of the user; and a base coupled with the sensor and the sharp to facilitate insertion of the sharp, deployment of the sensor, and withdrawal of the sharp.

[0215] Clause 67. The sensor deployment system of clause 66, wherein the sharp and a hub are integrally formed from a micro-moldable material.

[0216] Clause 68. The sensor deployment system of clause 67, wherein the sharp and the hub are formed by micro-molding the micro-moldable material in an axial direction. [0217] Clause 69. The sensor deployment system of clause 68, further comprising a sensor puck.

[0218] Clause 70. The sensor deployment system of clause 69, wherein a first base portion of the hub forms a seal with a second base portion of the sensor puck, thereby forming a sealed barrier around the sharp and the sensor puck.

[0219] Clause 71. The sensor deployment system of clause 70, further comprising: an elastomer disposed along the seal between the first base portion of the hub and the second base portion of the sensor puck.

[0220] Clause 72. The sensor deployment system of any of clauses 66-71, wherein the sensor deployment apparatus comprises a central axis; and wherein the point of the sharp lies along the central axis.

[0221] Clause 73. The sensor deployment system of clause 72, wherein the needle is integrally formed with the elongated main body.

[0222] Clause 74. The sensor deployment system of any of clauses 72-73, wherein the sharp and the hub comprise a plastic material.

[0223] Clause 75. The sensor deployment system of clause 74, wherein the plastic material is a biocompatible plastic.

[0224] Clause 76. The sensor deployment system of clause 75, wherein the plastic material comprises one of: polystyrene (PS), polypropylene (PP), polyvinyl chloride (PVC), polyethylene (PE), polyurethane (PU), polycarbonate (PC), polyethylene terephthalate (PET), or polyetheretherketone (PEEK).

[0225] Clause 77. The sensor deployment system of any of clauses 72-76, wherein the elongated main body comprises a first material and the needle comprises a second material having a greater stiffness than the first material.

[0226] Clause 78. The sensor deployment system of any of clauses 72-77, wherein the sharp is formed from a bioabsorbable material, such that the sharp is configured to be inserted into the skin surface of the user and remain at approximately the particular insertion depth until the bioabsorbable material is absorbed into surrounding tissue of the user.

[0227] Clause 79. The sensor deployment system of clause 78, wherein the sharp is detachable from the hub after insertion into the skin surface of the user.

[0228] Clause 80. The sensor deployment system of any of clauses 72-79, wherein the sensor deployment apparatus comprises a micro-moldable material. [0229] Clause 81. The sensor deployment system of any of clauses 74-80, wherein the sensor deployment apparatus further comprises a slip additive configured to reduce a friction coefficient associated with an outer surface of the sensor deployment apparatus.

[0230] Clause 82. The sensor deployment system of clause 81, wherein the slip additive comprises one or more fatty acid amides.

[0231] Clause 83. The sensor deployment system of any of clauses 72-82, further comprising an external lubricant applied to an outer surface of the sharp.

[0232] Clause 84. The sensor deployment system of any of clauses 67-83, wherein the sensor deployment apparatus is formed from micro-molding the micro-moldable material in an axial direction.

[0233] Clause 85. The sensor deployment system of any of clauses 72-84, wherein the channel is a partially open channel along a top portion of the elongated main body.

[0234] Clause 86. The sensor deployment system of clause 85, wherein the elongated main body comprises a rounded base and two opposing side walls extending upward from the rounded base, forming a u-shaped hollow channel within the elongated main body.

[0235] Clause 87. The sensor deployment system of clause 86, wherein the channel extends from a base portion of the hub to at least the proximal end of the elongated main body.

[0236] Clause 88. The sensor deployment system of clause 86, wherein the channel extends from a base portion of the hub to the distal end of the sharp.

[0237] Clause 89. The sensor deployment system of any of clauses 72-84, wherein the elongated main body is cylindrical, and the channel comprises an enclosed cylindrical hollow space within the elongated main body.

[0238] Clause 90. The sensor deployment system of clause 89, wherein the channel extends from the proximal end of the sharp to the distal end of the sharp.

[0239] Clause 91. The sensor deployment system of clause 89, wherein the channel extends from a proximal end of the hub to the distal end of the elongated main body.

[0240] Clause 92. The sensor deployment system of claim of clause 89, wherein the channel extends from a distal end of the hub to the distal end of the sharp.

[0241] Clause 93. The sensor deployment system of any of clauses 72-92, the distal end further comprising the needle partially disposed within the distal end of the sharp such that the needle extends from the distal end of the sharp.

[0242] Clause 94. The sensor deployment system of clause 93, wherein the needle comprises a metal material. [0243] Clause 95. The sensor deployment system of clause 94, wherein the metal material is stainless steel.

[0244] Clause 96. The sensor deployment system of clause 93, wherein the needle is a hypodermic needle.

[0245] Clause 97. The sensor deployment system of any of clauses 93-96, wherein the needle comprises a diameter between ,4mm and 1.8mm.

[0246] Clause 98. The sensor deployment system of clause 97, wherein the needle is an acupuncture needle.

[0247] Clause 99. The sensor deployment system of any of clauses 93-96, wherein the needle comprises a diameter between ,1mm and ,35mm.

[0248] Clause 100. The sensor deployment system of any of clauses 72-99, wherein the elongated main body further comprises an alignment feature disposed along a portion of a base surface of the elongated main body.

[0249] Clause 101. The sensor deployment system of clause 100, wherein the alignment feature is integrally formed with the elongated main body.

[0250] Clause 102. The sensor deployment system of any of clauses 72-101, wherein the distal end comprises a conical shape such that the point is a conical point.

[0251] Clause 103. The sensor deployment system of any of clauses 72-101, wherein the distal end comprises a pyramidal shape such that the point is an apex of the pyramidal shape.

[0252] Clause 104. The sensor deployment system of any of clauses 72-103, wherein an inner surface of the channel extends into a flat surface of the distal end of the sharp.

[0253] Clause 105. The sensor deployment system of any of clauses 72-101, wherein the distal end comprises a rounded point.

[0254] Clause 106. A sharp comprising: an elongated main body comprising: a distal end; a proximal end; a channel extending from the distal end to at least the proximal end within the elongated main body, the channel being configured to support and deploy a sensor at a particular insertion depth; and smooth outer surfaces; wherein at least a portion of the sharp including the distal end is formed from a bioabsorbable material, such that the portion of the sharp is configured to be inserted into a skin surface of a user and remain at approximately the particular insertion depth until the bioabsorbable material is absorbed into surrounding tissue of the user. [0255] Clause 107. The sharp of clause 106, wherein the is integrally formed with the elongated main body. [0256] Clause 108. The sharp of any of clauses 106-107, wherein the distal end of the elongated main body comprises a first material and the proximal end of the elongated main body comprises a second material having a greater stiffness than the first material.

[0257] Clause 109. The sharp of any of clauses 106-108, wherein the sharp is formed from a micro-moldable material.

[0258] Clause 110. The sharp of any of clauses 106-109, wherein the micro-moldable material further comprises a slip additive configured to reduce a friction coefficient associated with the micro-moldable material.

[0259] Clause 111. The sharp of clause 110, wherein the slip additive comprises one or more fatty acid amides.

[0260] Clause 112. The sharp of any of clauses 106-111, further comprising an external lubricant applied to the smooth outer surfaces of the sharp.

[0261] Clause 113. The sharp of any of clauses 106-112, wherein the sharp is formed from micro-molding the micro-moldable material in an axial direction.

[0262] Clause 114. The sharp of any of clauses 106-113, wherein the channel is a partially open channel along a top portion of the elongated main body.

[0263] Clause 115. The sharp of clause 114, wherein the elongated main body comprises a rounded base and two opposing side walls extending upward from the rounded base, forming a u-shaped hollow channel within the elongated main body.

[0264] Clause 116. The sharp of any of clauses 106-115, wherein the elongated main body is cylindrical, and the channel forms a cylindrical hollow space within the elongated main body.

[0265] Clause 117. The sharp of clause 116, wherein the channel extends from the proximal end of the sharp to the distal end of the sharp.

[0266] Clause 118. The sharp of any of clauses 106-117, the sharp further comprising a needle partially disposed within the distal end of the sharp such that the needle extends from the distal end of the sharp.

[0267] Clause 119. The sharp of clause 118, wherein the needle comprises a metal material.

[0268] Clause 120. The sharp of clause 119, wherein the metal material is stainless steel.

[0269] Clause 121. The sharp of clause 120, wherein the needle is hypodermic needle.

[0270] Clause 122. The sharp of any of clauses 118-121, wherein the needle comprises a diameter between ,4mm and 1.8mm.

[0271] Clause 123. The sharp of clause 122, wherein the needle is an acupuncture needle.

[0272] Clause 124. The sharp of any of clauses 118-123, wherein the needle comprises a diameter between ,1mm and ,35mm. [0273] Clause 125. The sharp of clause 118, wherein the needle comprises a micro-moldable material.

[0274] Clause 126. The sharp of any of clauses 118, wherein the needle comprises a bioabsorbable material.

[0275] Clause 127. The sharp of any of clauses 118, wherein the needle comprises a plastic material.

[0276] Clause 128. The sharp of any of clauses 106-127, wherein the sharp comprises a length between 1.5mm and 25mm.

[0277] Clause 129. The sharp of any of clauses 106-128, wherein the elongated main body comprises a diameter between 0.1mm and 0.5mm.

[0278] Clause 130. The sharp of any of clauses 106-129, wherein the elongated main body further comprises an alignment feature disposed along a portion of a base surface of the elongated main body.

[0279] Clause 131. The sharp of clause 130, wherein the alignment feature is integrally formed with the elongated main body.

[0280] Clause 132. The sharp of any of clauses 106-131, wherein the distal end comprises a conical shape such that the point is a conical point.

[0281] Clause 133. The sharp of any of clauses 106-132, wherein the distal end comprises a pyramidal shape such that the point is an apex of the pyramidal shape.

[0282] Clause 134. The sharp of clause 133, wherein an inner surface of the channel extends into a flat surface of the distal end of the sharp.

[0283] Clause 135. The sharp of clauses 118 and 134, wherein proximal ends of the two opposing side walls slope downward to the flat surface of the distal end of the sharp.

[0284] It should be noted that all features, elements, components, functions, and steps described with respect to any embodiment provided herein are intended to be freely combinable and substitutable with those from any other embodiment. If a certain feature, element, component, function, or step is described with respect to only one embodiment, then it should be understood that that feature, element, component, function, or step can be used with every other embodiment described herein unless explicitly stated otherwise. This paragraph therefore serves as antecedent basis and written support for the introduction of claims, at any time, that combine features, elements, components, functions, and steps from different embodiments, or that substitute features, elements, components, functions, and steps from one embodiment with those of another, even if the following description does not explicitly state, in a particular instance, that such combinations or substitutions are possible. Thus, the foregoing description of specific embodiments of the disclosed subject matter has been presented for purposes of illustration and description. It is explicitly acknowledged that express recitation of every possible combination and substitution is overly burdensome, especially given that the permissibility of each and every such combination and substitution will be readily recognized by those of ordinary skill in the art.

[0285] While the embodiments are susceptible to various modifications and alternative forms, specific examples thereof have been shown in the drawings and are herein described in detail. It will be apparent to those skilled in the art that various modifications and variations can be made in the method and system of the disclosed subject matter without departing from the spirit or scope of the disclosed subject matter. Thus, it is intended that the disclosed subject matter include modifications and variations that are within the scope of the appended claims and their equivalents. Furthermore, any features, functions, steps, or elements of the embodiments may be recited in or added to the claims, as well as negative limitations that define the inventive scope of the claims by features, functions, steps, or elements that are not within that scope.

Claims

CLAIMS What is claimed is:

1. A sharp comprising: an elongated main body comprising: a distal end configured to facilitate a proximal movement of the sharp through a skin surface of a user to approximately a particular insertion depth; a proximal end; a channel extending from the distal end to at least the proximal end within the elongated main body, the channel being configured to support and deploy a sensor at the particular insertion depth; and smooth outer surfaces; and a needle that extends past the distal end of the elongated main body and facilitates an initial penetration through the skin surface of the user.

2. The sharp of claim 1, wherein the needle comprises a metal material.

3. The sharp of claim 1, wherein the metal material is stainless steel.

4. The sharp of claim 1, wherein the elongated main body comprises a metal material.

5. The sharp of any of claims 1-4, wherein the needle comprises a diameter between ,4mm and 1.8mm.

6. The sharp of any of claims 1-3, wherein the elongated main body comprises a micro-moldable material that is over-molded with respect to the needle.

7. The sharp of claim 1, wherein the elongated main body and the needle comprise a micro-moldable material, wherein the sharp is formed from a single-shot injection molding process.

8. The sharp of any of claims 6-7, wherein the micro-moldable material further comprises a slip additive configured to reduce a friction coefficient associated with the micro- moldable material.

9. The sharp of claim 8, wherein the slip additive comprises one or more fatty acid amides.

10. The sharp of any of claims 1-9, further comprising an external lubricant applied to the smooth outer surfaces of the sharp.

11. The sharp of any of claims 6-10, wherein the sharp is formed from micro-molding the micro-moldable material in an axial direction.

12. The sharp of any of claims 1-11, wherein the channel is a partially open channel along a top portion of the elongated main body.

13. The sharp of claim 12, wherein the elongated main body comprises a rounded base and two opposing side walls extending upward from the rounded base, forming a u-shaped hollow channel within the elongated main body.

14. The sharp of any of claims 1-13, wherein the elongated main body is cylindrical, and the channel forms a cylindrical hollow space within the elongated main body.

15. The sharp of claim 14, wherein the channel extends from the proximal end of the sharp to the distal end of the sharp.

16. The sharp of any of claims 1-15, the distal end further comprising a needle partially disposed within the distal end of the sharp such that the needle extends from the distal end.

17. The sharp of claim 1, wherein the needle is integrally formed with the elongated main body.

18. The sharp of any of claims 1 or 17, wherein the micro-moldable material is a plastic material.

19. The sharp of any of claim 18, wherein the plastic material is a biocompatible plastic.

20. The sharp of claim 19, wherein the plastic material comprises one of: polystyrene (PS), polypropylene (PP), polyvinyl chloride (PVC), polyethylene (PE), polyurethane (PU), polycarbonate (PC), polyethylene terephthalate (PET), or polyetheretherketone (PEEK).

21. The sharp of any of claims 17-20, wherein the elongated main body comprises a first material and the needle comprises a second material having a greater stiffness than the first material.

22. The sharp of any of claims 17-21, wherein the sharp is formed from a bioabsorbable material, such that the sharp is configured to be inserted into the skin surface of the user and remain at approximately the particular insertion depth until the bioabsorbable material is absorbed into surrounding tissue of the user.

23. The sharp of any of claims 1-22, wherein the sharp comprises a length between 1.5mm and 25mm.

24. The sharp of any of claims 1-23, wherein the elongated main body comprises a diameter between 0.1mm and 0.5mm.

25. The sharp of any of claims 1-24, wherein the elongated main body further comprises an alignment feature disposed along a portion of a base surface of the elongated main body.

26. The sharp of claim 25, wherein the alignment feature is integrally formed with the elongated main body.

27. The sharp of any of claims 1-26, wherein the distal end comprises a conical shape such that the point is a conical point.

28. The sharp of any of claims 1-26, wherein the distal end comprises a pyramidal shape such that the point is an apex of the pyramidal shape.

29. The sharp of claim 28, wherein an inner surface of the channel extends into a flat surface of the distal end.

30. The sharp of claims 13 and 29, wherein proximal ends of the two opposing side walls slope downward to the flat surface of the distal end.

31. A sensor deployment apparatus comprising: a hub; and a sharp integrally formed with the hub, the sharp comprising: an elongated main body comprising: a channel extending from a distal end of the elongated main body to at least a proximal end of the elongated main body, the channel being configured to support and deploy a sensor at a particular insertion depth; and a needle configured to facilitate an initial penetration through a skin surface of a user.

32. The sensor deployment apparatus of claim 31, wherein the needle and hub are integrally formed with the elongated main body of the sharp.

33. The sensor deployment apparatus of any of claims 31-32, wherein the sharp and the hub comprise a plastic material.

34. The sensor deployment apparatus of any of claim 33, wherein the plastic material is a biocompatible plastic.

35. The sensor deployment apparatus of claim 34, wherein the plastic material comprises one of: polystyrene (PS), polypropylene (PP), polyvinyl chloride (PVC), polyethylene (PE), polyurethane (PU), polycarbonate (PC), polyethylene terephthalate (PET), or polyetheretherketone (PEEK).

36. The sensor deployment apparatus of any of claims 31-35, wherein the elongated main body comprises a first material and the hub comprises a second material having a lesser stiffness than the first material.

37. The sensor deployment apparatus of any of claims 31-36, wherein the sharp is formed from a bioabsorbable material, such that the sharp is configured to be inserted into the skin surface of the user and remain at approximately the particular insertion depth until the bioabsorbable material is absorbed into surrounding tissue of the user.

38. The sensor deployment apparatus of claim 37, wherein the sharp is detachable from the hub after insertion into the skin surface of the user.

39. The sensor deployment apparatus of any of claims 31-38, wherein the sensor deployment apparatus comprises a micro-moldable material.

40. The sensor deployment apparatus of any of claims 33-39, wherein the sensor deployment apparatus further comprises a slip additive configured to reduce a friction coefficient associated with an outer surface of the sensor deployment apparatus.

41. The sensor deployment apparatus of claim 40, wherein the slip additive comprises one or more fatty acid amides.

42. The sensor deployment apparatus of any of claims 31-41, further comprising an external lubricant applied to an outer surface of the sharp.

43. The sensor deployment apparatus of any of claims 39-42, wherein the sensor deployment apparatus is formed from micro-molding the micro-moldable material in an axial direction.

44. The sensor deployment apparatus of any of claims 31-43, wherein the channel is a partially open channel along a top portion of the elongated main body.

45. The sensor deployment apparatus of claim 44, wherein the elongated main body comprises a rounded base and two opposing side walls extending upward from the rounded base, forming a u-shaped hollow channel within the elongated main body.

46. The sensor deployment apparatus of claim 45, wherein the channel extends from a base portion of the hub to at least the proximal end of the elongated main body.

47. The sensor deployment apparatus of claim 45, wherein the channel extends from a base portion of the hub to the distal end of the sharp.

48. The sensor deployment apparatus of any of claims 31-43, wherein the elongated main body is cylindrical, and the channel comprises an enclosed cylindrical hollow space within the elongated main body.

49. The sensor deployment apparatus of claim 48, wherein the channel extends from the proximal end of the sharp to the distal end of the sharp.

50. The sensor deployment apparatus of claim 48, wherein the channel extends from a distal end of the hub to the proximal end of the elongated main body.

51. The sensor deployment apparatus of claim of claim 48, wherein the channel extends from a distal end of the hub to the distal end of the sharp.

52. The sensor deployment apparatus of any of claims 31-51, the distal end further comprising a needle partially disposed within the distal end of the sharp such that the needle extends from the distal end of the sharp.

53. The sensor deployment apparatus of claim 52, wherein the needle comprises a metal material.

54. The sensor deployment apparatus of claim 53, wherein the metal material is stainless steel.

55. The sensor deployment apparatus of claim 52, wherein the needle is hypodermic needle.

56. The sensor deployment apparatus of any of claims 52-55, wherein the needle comprises a diameter between ,4mm and 1.8mm.

57. The sensor deployment apparatus of claim 56, wherein the needle is an acupuncture needle.

58. The sensor deployment apparatus of any of claims 52-55, wherein the needle comprises a diameter between ,1mm and ,35mm.

59. The sensor deployment apparatus of any of claims 31-58, wherein the elongated main body further comprises an alignment feature disposed along a portion of a base surface of the elongated main body.

60. The sensor deployment apparatus of claim 59, wherein the alignment feature is integrally formed with the elongated main body.

61. The sensor deployment apparatus of any of claims 31-60, wherein the distal end of the sharp comprises a conical shape such that the point is a conical point.

62. The sensor deployment apparatus of any of claims 31-60, wherein a distal end of the sharp comprises a pyramidal shape such that the point is an apex of the pyramidal shape.

63. The sensor deployment apparatus of any of claims 61-62, wherein an inner surface of the channel extends into a flat surface of the distal end.

64. The sensor deployment apparatus of any of claims 31-60, wherein the distal end is of the sharp comprises a rounded point.

65. The sensor deployment apparatus of any of claims 31-64, wherein the sensor deployment apparatus comprises a central axis; and wherein the point of the sharp lies along the central axis.

66. A sensor deployment system comprising: a sensor; a sensor deployment apparatus comprising: a sharp comprising: an elongated main body comprising: a channel extending from a distal end of the elongated main body to at least a proximal end of the elongated main body, the channel being configured to support and deploy the sensor at a particular insertion depth under a skin surface of a user; and a needle configured to facilitate an initial penetration through the skin surface of the user; and a base coupled with the sensor and the sharp to facilitate insertion of the sharp, deployment of the sensor, and withdrawal of the sharp.

67. The sensor deployment system of claim 66, wherein the sharp and a hub are integrally formed from a micro-moldable material.

68. The sensor deployment system of claim 67, wherein the sharp and the hub are formed by micro-molding the micro-moldable material in an axial direction.

69. The sensor deployment system of claim 68, further comprising a sensor puck.

70. The sensor deployment system of claim 69, wherein a first base portion of the hub forms a seal with a second base portion of the sensor puck, thereby forming a sealed barrier around the sharp and the sensor puck.

71. The sensor deployment system of claim 70, further comprising: an elastomer disposed along the seal between the first base portion of the hub and the second base portion of the sensor puck.

72. The sensor deployment system of any of claims 66-71, wherein the sensor deployment apparatus comprises a central axis; and wherein the point of the sharp lies along the central axis.

73. The sensor deployment system of claim 72, wherein the needle is integrally formed with the elongated main body.

74. The sensor deployment system of any of claims 72-73, wherein the sharp and the hub comprise a plastic material.

75. The sensor deployment system of claim 74, wherein the plastic material is a biocompatible plastic.

76. The sensor deployment system of claim 75, wherein the plastic material comprises one of: polystyrene (PS), polypropylene (PP), polyvinyl chloride (PVC), polyethylene (PE), polyurethane (PU), polycarbonate (PC), polyethylene terephthalate (PET), or polyetheretherketone (PEEK).

77. The sensor deployment system of any of claims 72-76, wherein the elongated main body comprises a first material and the needle comprises a second material having a greater stiffness than the first material.

78. The sensor deployment system of any of claims 72-77, wherein the sharp is formed from a bioabsorbable material, such that the sharp is configured to be inserted into the skin surface of the user and remain at approximately the particular insertion depth until the bioabsorbable material is absorbed into surrounding tissue of the user.

79. The sensor deployment system of claim 78, wherein the sharp is detachable from the hub after insertion into the skin surface of the user.

80. The sensor deployment system of any of claims 72-79, wherein the sensor deployment apparatus comprises a micro-moldable material.

81. The sensor deployment system of any of claims 74-80, wherein the sensor deployment apparatus further comprises a slip additive configured to reduce a friction coefficient associated with an outer surface of the sensor deployment apparatus.

82. The sensor deployment system of claim 81, wherein the slip additive comprises one or more fatty acid amides.

83. The sensor deployment system of any of claims 72-82, further comprising an external lubricant applied to an outer surface of the sharp.

84. The sensor deployment system of any of claims 67-83, wherein the sensor deployment apparatus is formed from micro-molding the micro-moldable material in an axial direction.

85. The sensor deployment system of any of claims 72-84, wherein the channel is a partially open channel along a top portion of the elongated main body.

86. The sensor deployment system of claim 85, wherein the elongated main body comprises a rounded base and two opposing side walls extending upward from the rounded base, forming a u-shaped hollow channel within the elongated main body.

87. The sensor deployment system of claim 86, wherein the channel extends from a base portion of the hub to at least the proximal end of the elongated main body.

88. The sensor deployment system of claim 86, wherein the channel extends from a base portion of the hub to the distal end of the sharp.

89. The sensor deployment system of any of claims 72-84, wherein the elongated main body is cylindrical, and the channel comprises an enclosed cylindrical hollow space within the elongated main body.

90. The sensor deployment system of claim 89, wherein the channel extends from the proximal end of the sharp to the distal end of the sharp.

91. The sensor deployment system of claim 89, wherein the channel extends from a proximal end of the hub to the distal end of the elongated main body.

92. The sensor deployment system of claim of claim 89, wherein the channel extends from a distal end of the hub to the distal end of the sharp.

93. The sensor deployment system of any of claims 72-92, the distal end further comprising the needle partially disposed within the distal end of the sharp such that the needle extends from the distal end of the sharp.

94. The sensor deployment system of claim 93, wherein the needle comprises a metal material.

95. The sensor deployment system of claim 94, wherein the metal material is stainless steel.

96. The sensor deployment system of claim 93, wherein the needle is a hypodermic needle.

97. The sensor deployment system of any of claims 93-96, wherein the needle comprises a diameter between ,4mm and 1.8mm.

98. The sensor deployment system of claim 97, wherein the needle is an acupuncture needle.

99. The sensor deployment system of any of claims 93-96, wherein the needle comprises a diameter between ,1mm and ,35mm.

100. The sensor deployment system of any of claims 72-99, wherein the elongated main body further comprises an alignment feature disposed along a portion of a base surface of the elongated main body.

101. The sensor deployment system of claim 100, wherein the alignment feature is integrally formed with the elongated main body.

102. The sensor deployment system of any of claims 72-101, wherein the distal end comprises a conical shape such that the point is a conical point.

103. The sensor deployment system of any of claims 72-101, wherein the distal end comprises a pyramidal shape such that the point is an apex of the pyramidal shape.

104. The sensor deployment system of any of claims 72-103, wherein an inner surface of the channel extends into a flat surface of the distal end of the sharp.

105. The sensor deployment system of any of claims 72-101, wherein the distal end comprises a rounded point.

106. A sharp comprising: an elongated main body comprising: a distal end; a proximal end; a channel extending from the distal end to at least the proximal end within the elongated main body, the channel being configured to support and deploy a sensor at a particular insertion depth; and smooth outer surfaces; wherein at least a portion of the sharp including the distal end is formed from a bioabsorbable material, such that the portion of the sharp is configured to be inserted into a skin surface of a user and remain at approximately the particular insertion depth until the bioabsorbable material is absorbed into surrounding tissue of the user.

107. The sharp of claim 106, wherein the is integrally formed with the elongated main body.

108. The sharp of any of claims 106-107, wherein the distal end of the elongated main body comprises a first material and the proximal end of the elongated main body comprises a second material having a greater stiffness than the first material.

109. The sharp of any of claims 106-108, wherein the sharp is formed from a micro- moldable material.

110. The sharp of any of claims 106-109, wherein the micro-moldable material further comprises a slip additive configured to reduce a friction coefficient associated with the micro- moldable material.

111. The sharp of claim 110, wherein the slip additive comprises one or more fatty acid amides.

112. The sharp of any of claims 106-111, further comprising an external lubricant applied to the smooth outer surfaces of the sharp.

113. The sharp of any of claims 106-112, wherein the sharp is formed from micromolding the micro-moldable material in an axial direction.

114. The sharp of any of claims 106-113, wherein the channel is a partially open channel along a top portion of the elongated main body.

115. The sharp of claim 114, wherein the elongated main body comprises a rounded base and two opposing side walls extending upward from the rounded base, forming a u-shaped hollow channel within the elongated main body.

116. The sharp of any of claims 106-115, wherein the elongated main body is cylindrical, and the channel forms a cylindrical hollow space within the elongated main body.

117. The sharp of claim 116, wherein the channel extends from the proximal end of the sharp to the distal end of the sharp.

118. The sharp of any of claims 106-117, the sharp further comprising a needle partially disposed within the distal end of the sharp such that the needle extends from the distal end of the sharp.

119. The sharp of claim 118, wherein the needle comprises a metal material.

120. The sharp of claim 119, wherein the metal material is stainless steel.

121. The sharp of claim 120, wherein the needle is hypodermic needle.

122. The sharp of any of claims 118-121, wherein the needle comprises a diameter between ,4mm and 1.8mm.

123. The sharp of claim 122, wherein the needle is an acupuncture needle.

124. The sharp of any of claims 118-123, wherein the needle comprises a diameter between ,1mm and ,35mm.

125. The sharp of claim 118, wherein the needle comprises a micro-moldable material.

126. The sharp of any of claims 118, wherein the needle comprises a bioabsorbable material.

127. The sharp of any of claims 118, wherein the needle comprises a plastic material.

128. The sharp of any of claims 106-127, wherein the sharp comprises a length between 1.5mm and 25mm.

129. The sharp of any of claims 106-128, wherein the elongated main body comprises a diameter between 0.1mm and 0.5mm.

130. The sharp of any of claims 106-129, wherein the elongated main body further comprises an alignment feature disposed along a portion of a base surface of the elongated main body.

131. The sharp of claim 130, wherein the alignment feature is integrally formed with the elongated main body.

132. The sharp of any of claims 106-131, wherein the distal end comprises a conical shape such that the point is a conical point.

133. The sharp of any of claims 106-132, wherein the distal end comprises a pyramidal shape such that the point is an apex of the pyramidal shape.

134. The sharp of claim 133, wherein an inner surface of the channel extends into a flat surface of the distal end of the sharp.

135. The sharp of claims 118 and 134, wherein proximal ends of the two opposing side walls slope downward to the flat surface of the distal end of the sharp.