RU2823731C1 - Blood infusion and collection devices - Google Patents

Abstract

FIELD: medicine.

SUBSTANCE: invention relates to medical equipment, namely to devices for continuous introduction of liquid into a living body during pure blood collection processes. Embodiments include an intravenous device in which a first fluid channel is formed, configured to provide selective movement of intravenous fluid into a living body and removing the biological fluid from said body, and a connector configured to connect the catheter to said first fluid channel and having a concave far end. Second fluid channel is configured to provide a continuous supply of intravenous fluid into the lumen coaxially located inside the catheter. Concave surface is shaped to form a fluid flow path that enables fast and complete removal of the residual biological fluid remaining on the concave far end. Embodiments include a concave surface having the shape of an asymmetric funnel, the top of which is made at the centre of said first fluid channel.

EFFECT: implementation of the purpose.

20 cl, 52 dwg

Description

LINK TO RELATED APPLICATION

[0001] This international application claims priority under the Patent Cooperation Treaty from U.S. Provisional Patent Application No. 62/940,596, filed November 26, 2019, entitled “Blood Infusion and Collection Devices and Methods,” the contents of which are incorporated herein by reference.

FIELD OF INVENTION

[0002] The present invention relates to a device and method for infusion and collection of blood. In particular, the present invention relates to a device for infusion and collection of blood, which ensures clean collection of blood by means of an angiocatheter, pre-installed for introduction of intravenous media. The present invention also relates to a method of using the device for infusion and collection of blood for removal of blood from a patient by means of a pre-installed angiocatheter.

LEVEL OF TECHNOLOGY

[0003] U.S. Patent 3,610,226 (Albisser) discloses an instrument formed by a double-lumen cannula for collecting blood over a long period of time. The instrument has an inner lumen for collecting blood and an outer lumen for introducing an anticoagulant diluent. The relative positioning of the openings for the inner and outer lumens ensures mixing of the diluent with the blood being collected.

[0004] U.S. Patent 5,374,245 (Mahurkar) discloses an extruded reinforced multi-lumen catheter for use in medicine in which fluids are to be simultaneously passed to and from a patient. Blood is withdrawn for a medical procedure (e.g., dialysis) from a patient through one passage and returned to the patient through another passage located at a distance from said first passage.

[0005] U.S. Patent 5,607,401 (Humphrey) discloses reinforced polymeric hypodermic needles and lancets. The polymeric needles and lancets are reinforced with reinforcements that include a sliding guard or foam insert to ensure that they penetrate the skin. Without the reinforcements, the polymeric hypodermic lancet does not provide the ability to penetrate the skin.

[0006] U.S. Patent 5,637,399 (Yoshikawa et al.) discloses a needle made of extruded synthetic resin reinforced with flammable fibers. The needle provides a single pathway for introducing or withdrawing media from a patient.

[0007] The above-described solutions known from the prior art do not provide for a catheter assembly that would provide the possibility of long-term insertion into a patient for the simultaneous introduction of intravenous media and periodic blood collection without mixing the intravenous medium with the blood being collected.

[0008] U.S. Patent 6,758,835 (Klose et al.) discloses a microinjection molded replacement needle assembly having more than one passage formed therein to provide for the simultaneous withdrawal and introduction of media through separate passages. The microinjection molded replacement assembly contains one or more sensors located therein to measure and monitor one or more desired parameters of the body or environment. A method for producing a replacement needle from an elastomeric material by microinjection molding is also disclosed.

[0009] This invention is a continuation in part of the apparatus and method disclosed in U.S. Patent 6,758,835 (Klose et al.). Accordingly, the invention described in U.S. Patent 6,758,835 is incorporated herein by reference in its entirety.

[0010] The devices described in the above prior art documents are mainly devoted to catheter portions with needle assemblies that are designed to be inserted into patients over a long period of time for the simultaneous administration of intravenous fluids and the collection of blood without mixing the intravenous fluid with the blood being collected.

[0011] Unlike the above-described prior art, the present invention does not focus primarily on the catheter portion of the needle assembly. Instead, a device is provided that can be inserted between a standard, pre-installed intravenous catheter (e.g., a peripheral venous catheter) and a standard intravenous infusion line and allows for clean blood collection without interrupting intravenous therapy for the patient. For example, intravenous infusion pumps are typically stopped for 30 seconds or more during any blood collection from a peripheral catheter, and the connection between the intravenous catheter and the infusion line is disconnected to conduct a blood sample through the intravenous catheter and prevent mixing with the collected blood, which can lead to erroneous results. If the intravenous infusion pump is not stopped and a downstream valve (e.g., a two-, three-, or four-way stop valve) is used to stop the infusion of infusate, a pump alarm is triggered, requiring personnel attention, since the line is considered occluded. Such fluid infusion limitation alarms in intravenous infusion pumps are typically triggered when the pressure of the infused fluid is increased to more than 68.95 kPa (10 psi). By means of the device that prevents interruption of intravenous therapy, the intravenous infusion pump is prevented from stopping or triggering an infusion limitation alarm. In addition, the purpose of this device is to reduce the complexity of the flow transmission part of the commonly used infusion and blood collection devices. Thus, while in some of the above-described prior art devices for ensuring clean blood collection, the pressure is determined and regulated in an active mode, the present invention provides the ability to regulate the pressure in a passive mode or, alternatively or additionally, in an active mode.

[0012] When a patient is admitted to a hospital, emergency department, or other healthcare facility, in the vast majority of cases, the patient will have some type of intravenous catheter inserted into the patient. In some cases, the intravenous catheter is inserted immediately upon admission to provide the required therapy. In other cases, the intravenous catheter is inserted simply for risk reasons to prepare the catheter in case healthcare workers need to quickly administer medications or fluids to the patient. The cannula portion of the intravenous catheter is placed into a blood vessel, typically in the forearm, hand, or other location on the patient's body (i.e., on the body of any living organism, such as a human, dog, cat, horse, etc.), and the connecting portion of the intravenous catheter for providing the intravenous infusion is typically secured to the outside of the patient's body by any available means - tapes, adhesive bandages, straps, or other means.

[0013] The average hospital stay for a patient is about three days, during which time it has been found that on average two or more lab tests may be performed per day. This means that at least twice a day a medical technician must collect the patient's blood, which is then sent to the lab for testing and/or analysis. Typically, if the patient already has a catheter in one arm through which medications or fluids are administered, the health care worker must use the patient's other arm or another part of the body to collect the blood. This means that during an average three-day hospital stay there are at least six occasions when the patient may be repeatedly pricked with a needle, which means at least six opportunities for potential infections, bruises, missed injections, skin irritation from bandages, and other agents. Additionally, particularly in situations involving pediatric patients, patients with hemophilia, HIV-infected patients, patients with dementia and/or similar conditions, and/or other excitable patients who may suffer from needle stick anxiety or have other increased risks associated with additional needle insertions, a patient may be exposed to trauma at least six times during a hospital stay, complicating the blood collection process or creating other risks.

[0014] Additionally, in some situations, a healthcare professional may use a catheter already in place in a patient's body to withdraw blood for testing. In such situations, the professional must typically temporarily interrupt the administration of drugs or fluids and perform a lengthy, drawn-out series of washing steps to protect against accidental contamination of the blood sample with residual intravenous solutions, drugs, or fluids and to ensure the purity of the blood sample. Without such washing steps, the blood sample may, for example, be diluted with residual intravenous solution, resulting in erroneous test results. Similarly, for example, contamination of the blood sample with residual intravenous solution containing sodium and/or potassium compounds may result in false test results indicating higher concentrations of these substances.

ESSENCE OF THE INVENTION

[0015] As will be apparent from the following description, the device and method according to the invention described herein is considered to provide an advantage because it alleviates and solves all of the above problems and issues related to blood removal. The device takes advantage of the passage of an intravenous catheter already installed in the patient's body and provides a simple procedure for performing a clean blood removal without interrupting the administration of intravenous therapy after the initial placement of the catheter. The device further includes passive control of the volumetric flow rate of the blood collection to prevent contamination of the collected blood with intravenous therapy fluid simultaneously administered through this catheter. The device is simply installed by insertion into the intravenous catheter line already installed in the patient's body and performs the steps of removing blood samples almost automatically. Additionally, the advantage of this device is that it uses the vacuum in a standard blood collection container, such as a Vacutainer® tube (trade name Becton, Dickinson and Company, Franklin Lake, NJ) or Vacuette® tube (trade name Greiner Bio One, Monroe, NC), as the driving mechanism for drawing a blood sample from a patient.

[0016] In an illustrative embodiment of the device (indicating the far/near side of the device, not the patient's body), a medical tube (e.g., a microlumen) is inserted coaxially through the distal end of another medical tube (e.g., a catheter) inserted into the patient's body and protrudes from it at the distal end. The microlumen and the catheter are in fluid communication with a bypass valve and a valve body. The valve body receives intravenous therapy fluid from an infusion line and provides selective control in an infusion/non-collection mode and in an infusion/collection mode. In the infusion/non-collection mode, intravenous therapy fluid is supplied to both the microlumen and the catheter. In the infusion/blood collection mode, a blood collection component, such as a vacuum collection tube holder connected to the collection body, receives blood from the catheter, and the microlumen simultaneously continues to supply intravenous therapy fluid to the patient.

[0017] The length of the protrusion and the flow rate during blood collection are essential for the present invention to prevent mixing and thus contamination of the collected blood with intravenous fluids in the infusion/collection mode. For example, the difference in pressure between a vacuum blood collection tube and the pressure in a vein of a normal patient is approximately 2 orders of magnitude. For example, the vacuum in the tube can reach about 93.33 kPa (700 mmHg), and the pressure in the vein is about 933.26 Pa (7 mmHg). Thus, mixing of the collected blood with intravenous fluids at the collection point in the vein is prevented by the combination of 1) the device limiting the flow rate of the collected blood being withdrawn from the vein into the catheter, and 2) the distal end of the microlumen used to simultaneously infuse the infusate into the vein is located far enough in the vein from the distal end of the intravenous catheter where the blood is being withdrawn from the vein.

[0018] While an illustrative embodiment of the present invention relates to an angiocatheter (i.e., an intravenous catheter), it should be understood that, as provided herein, the invention may be applicable to other catheters known in the art, such as, for example, peripherally inserted cardiac catheters, a central catheter, and the like.

[0019] The object of the present invention is to provide a blood infusion and collection device that enables clean collection of blood from a patient through a previously placed catheter, such as a peripheral venous catheter, also known as an angiocatheter, without interrupting the administration of intravenous therapy after initial placement.

[0020] Another object of the present invention is to provide a blood infusion and collection device that enables the collection of clean blood from a patient through a previously installed catheter, without the need for repeated needle insertion into another location of the patient's body away from the already installed catheter.

[0021] Another object of the present invention is to provide a blood infusion and collection device that allows for clean collection of blood from a patient through a previously installed catheter without exposing the patient to an increased risk of infection from repeated and multiple needle sticks.

[0022] Another object of the present invention is to provide a blood infusion and collection device that enables clean blood collection from a patient through a previously inserted catheter, wherein the patient is a pediatric patient, a hemophiliac patient, an HIV patient, a patient with dementia and/or a similar condition and/or any patient who may be agitated or may suffer from needle stick anxiety or have other increased risks associated with additional needle insertions.

[0023] Another object of the present invention is to provide a blood infusion and collection device that enables clean collection of blood from a patient through a previously inserted catheter without the need to temporarily stop the administration of drugs or fluids and perform a lengthy, drawn-out series of flushing steps to protect against accidental contamination of the blood sample with residual intravenous infusion solutions, drugs or fluids.

[0024] Another object of the present invention is to provide a blood infusion and collection device that enables clean collection of blood from a patient through a previously installed catheter in order to reduce the time and demands on hospital staff to care for the patient.

[0025] The present invention relates to a device and method for removing blood that are used in conjunction with a previously installed peripheral venous catheter/intravenous infusion line in the patient's body. The device and method provide an advantage because they allow blood to be removed through a previously installed catheter without the need to interrupt the intravenous flow.

[0026] Another advantage of the device and method is the reduction in the number of venipunctures that need to be performed on a patient's body. This provides many potential benefits, such as reducing potential infection rates, reducing patient anxiety, reducing the time and patient care costs for hospital staff, and reducing the cost of disposing of biohazardous blood collection needle sets.

[0027] Another advantage is that the access passage of the blood collection device is closed to prevent the passage from opening and introducing bacteria from the outside environment that could either contaminate or damage the passage, which in turn could result in bodily injury.

[0028] One illustrative embodiment of a blood infusion and collection device for use with a patient catheter and an intravenous infusion line that provide intravenous administration of a therapeutic fluid into a patient's body comprises a blood collection component having an outlet inlet; a housing comprising a drive means and an intravenous infusion inlet connected to the intravenous infusion line, wherein the drive means provides at least an infusion/non-collection operating mode and an infusion/collection operating mode for the device; a microlumen aligned with the patient catheter and in fluid communication with the intravenous infusion inlet; a blood collection channel in fluid communication with the catheter, wherein the blood collection channel is configured to be directly accessible through the outlet inlet of the blood collection component; wherein in the infusion/non-collection mode, the drive means provides a flow communication between the blood collection channel and the intravenous infusion inlet, and in the infusion/collection mode, the drive means fluidly isolates the blood collection channel from the intravenous infusion inlet.

[0029] The blood collection channel may be self-flushing with intravenous therapy fluid in the infusion/non-collection mode. The device may further comprise a passive restriction means that limits the flow rate of blood withdrawn through the catheter in the infusion/collection mode, thereby preventing mixing of the withdrawn blood with the intravenous therapy fluid supplied through the micro-lumen. The blood collection component may be removably attached to said housing. The drive means may be actuated in the infusion/collection mode by interaction of the blood collection component with the housing, wherein the drive means is actuated in the infusion/non-collection mode by releasing the blood collection component from interaction with the housing. The interaction may include axial and rotational movement of the blood collection component relative to the housing, wherein the axial movement places the outlet inlet into flow communication with the blood collection component, and the rotational movement actuates the drive means.

[0030] The outlet inlet may include a needle positioned so as to pass into the blood collection channel in the infusion/collection mode. The blood collection component is configured to provide a fluid communication of the vacuum blood collection tube with the blood collection channel. The drive means may include a rotary valve. The rotary valve may be a two-way valve having two open passages and a third selective passage, wherein the valve restricts at least a portion of the blood collection channel. The outlet inlet of the blood collection component is configured to pass through the third selective passage into a portion of the blood collection channel formed by the rotary valve. The micro-lumen may extend beyond the distal end of the catheter so that the distal end of the micro-lumen is located further behind the distal end of the catheter. The micro-lumen may be inserted coaxially through the catheter. The patient catheter may include a catheter fluid connector. The housing may include a head fluid connector for connecting to the catheter connector. The micro-lumen may exit the housing inside the head connector. The blood collection channel may be in fluid communication with the head connector.

[0031] Another exemplary embodiment of a blood infusion and collection device for use with a patient catheter and an intravenous infusion line providing intravenous fluid therapy to a patient, comprises a blood collection component; a housing comprising a drive means and an intravenous infusion inlet coupled to the intravenous infusion line, wherein the drive means provides at least an infusion/non-collection operating mode and an infusion/collection operating mode for the device; a micro-lumen aligned with the patient catheter, wherein the micro-lumen is in fluid communication with the intravenous infusion inlet; a blood collection channel in fluid communication with the catheter, and a passive restriction means that limits the volumetric flow rate of blood withdrawn by the catheter in the infusion/collection mode, thereby preventing mixing of the withdrawn blood with the intravenous therapy fluid through the micro-lumen; wherein in the infusion/non-collection mode, the drive device provides a flow connection between the blood collection channel and the intravenous infusion inlet, and in the infusion/collection mode, the drive device flow isolates the blood collection channel from the intravenous infusion inlet.

[0032] The passive restriction means may be a thin elongated tube fluidly connecting the blood collection component and the blood collection channel. The micro-lumen may be located coaxially within the catheter, and the distal end of the micro-lumen extends further beyond the distal end of the catheter. The blood collection component is configured to fluidly connect the evacuated blood collection tube to the blood collection channel. The blood collection component may be removably attached to the housing. The drive means may be actuated in the infusion/blood collection mode by interaction of the blood collection component with the housing, while actuation of the drive means in the infusion/non-collection mode is ensured by removing the blood collection component from interactions with the housing. The interaction may include axial and rotational movement of the blood collection component relative to the housing, wherein the axial movement ensures placement of the elongated tube in fluid communication with the blood collection component, and the rotational movement actuates the drive means.

[0033] Another illustrative embodiment of a blood infusion and collection device for use with a patient catheter and an intravenous infusion line to provide fluid for intravenous therapy to a patient comprises a housing comprising a drive means and an intravenous infusion inlet coupled to the intravenous infusion line, wherein the drive means provides at least an infusion/non-collection operating mode and an infusion/collection operating mode for the device; a micro-lumen configured to extend coaxially through the patient catheter, wherein a distal end of the micro-lumen extends beyond the distal end of the catheter, wherein the micro-lumen is in fluid communication with the intravenous infusion inlet; a blood collection channel in fluid communication with the catheter, and a blood collection tube holder removably attached to the housing and comprising an exit needle that can be selectively in fluid communication with the blood collection channel in an infusion/collection mode, wherein the exit needle provides a restriction that limits the volumetric flow rate of blood withdrawn through the catheter in the infusion/collection mode, thereby preventing mixing of the withdrawn blood with the intravenous therapy fluid passing through the microlumen; wherein in the infusion/non-collection mode, the drive device provides a fluid connection of the blood collection channel with the intravenous infusion inlet, and in the infusion/collection mode, the drive device fluidly isolates the blood collection channel from the intravenous infusion inlet.

BRIEF DESCRIPTION OF DRAWINGS

[0034] The detailed description refers in particular to the accompanying drawings.

In the drawings:

[0035] Fig. 1 depicts an assembled perspective view of a first illustrative embodiment of a blood infusion and collection device used with an intravenous infusion line and a peripheral venous catheter;

[0036] Fig. 2A schematically depicts the fluid system of the device shown in Fig. 1 in an infusion/non-collection mode;

[0037] Fig. 2B and 2C schematically illustrate the fluid system of the device shown in Fig. 1 in an infusion/collection mode;

[0038] Fig. 3 shows in axonometric and disassembled form a part of the valve body of the device shown in Fig. 1;

[0039] Fig. 4 is a perspective and exploded view of a portion of the blood collection tube holder of the device shown in Fig. 1;

[0040] Fig. 5 is a top perspective view of the assembled device shown in Fig. 1 prior to use;

[0041] Fig. 6 is a bottom perspective view of the assembled device shown in Fig. 1 prior to use and with the protective cap over the micro-lumen removed;

[0042] Fig. 7A is an assembled perspective view of the device of Fig. 1 positioned with an intravenous infusion line and a peripheral venous catheter, the device being in an infusion/non-collection mode and the tube holder being prepared for engagement with the valve body;

[0043] Fig. 7B is a sectional view of the valve body and separated tube holder taken along section line 7B-7B shown in Fig. 7A and with the device in the infusion/non-collection mode;

[0044] Fig. 7C is a sectional view of the valve body taken along section line 7C-7C shown in Fig. 7B with the device in the infusion/non-collection mode;

[0045] Fig. 8A is an assembled perspective view of the device shown in Fig. 1, with the device in the infusion/non-collection mode and the tube holder connected to the valve body and not yet rotated;

[0046] Fig. 8B is a sectional view of the valve body and connected tube holder taken along section line 8B-8B shown in Fig. 8A with the device in the infusion/non-collection mode;

[0047] Fig. 8C is a sectional view of the valve body taken along section line 8C-8C shown in Fig. 8B with the device in the infusion/non-collection mode;

[0048] Fig. 9A is an assembled perspective view of the device shown in Fig. 1, wherein the device is in the infusion/collection mode and the tube holder is connected to the valve body and rotated, wherein the blood collection tube is connected to the tube holder;

[0049] Fig. 9B is a sectional view of the valve body and the connected tube holder and collection tube taken along section line 9B-9B shown in Fig. 9A with the device in the infusion/collection mode;

[0050] Fig. 9C is a sectional view of the valve body taken along section line 9C-9C shown in Fig. 9B with the device in the infusion/collection mode;

[0051] Fig. 10A is an assembled perspective view of the device shown in Fig. 1, with the device returned to the infusion/non-collection mode and the holder rotated back and detached from the valve body;

[0052] Fig. 10B is a cross-sectional view of the valve body and connected tube holder taken along section line 10B-10B shown in Fig. 10A with the device in the infusion/non-collection mode;

[0053] Fig. 10C is a sectional view of the valve body taken along section line 10C-10C shown in Fig. 10B with the device in the infusion/non-collection mode;

[0054] Fig. 11 is a perspective view of a second illustrative embodiment of a blood infusion and collection device according to the present invention, illustratively shown installed between an intravenous infusion line and a peripheral venous catheter;

[0055] Fig. 12 shows in axonometric view a transfer and collection unit according to a second embodiment of the device shown in Fig. 11;

[0056] Fig. 13 is a perspective view of a catheter head assembly according to a second embodiment of the device shown in Fig. 11;

[0057] Fig. 14 is a top perspective view of a transfer valve and a collection housing according to a second embodiment of the device shown in Fig. 11;

[0058] Fig. 15 is a bottom perspective view of a collection tube holder according to a second embodiment of the device shown in Fig. 11;

[0059] Fig. 16 is a top perspective view of the transfer valve housing according to a second embodiment of the device shown in Fig. 11;

[0060] Fig. 17 is a top perspective view of the transfer valve housing shown in Fig. 16 with the rotary valve actuator removed;

[0061] Fig. 18 is a translucent top view of the transfer valve housing of Fig. 17 showing the infusion and collection channels in the device;

[0062] Fig. 19 is a perspective view of the rotary valve and the drive means of the transfer valve housing shown in Fig. 17;

[0063] Fig. 20 is a translucent top view of the transfer valve housing of Fig. 17 in an infusion/non-collection mode and showing intravenous flow in all channels;

[0064] Fig. 21 is a translucent top view of the transfer valve housing of Fig. 17 in an infusion/collection mode and showing intravenous flow in the intravenous channel and blood flow in the blood collection channel;

[0065] Fig. 22 is a sectional view of the transfer valve housing and test tube holder shown in Fig. 12, taken along section line 22-22;

[0066] Fig. 23 is a sectional view of the head assembly for the catheter shown in Fig. 13 taken along section line 23-23;

[0067] Fig. 24 is a sectional view of the catheter head assembly shown in Fig. 13 taken along section line 24-24 and showing intravenous flow in the intravenous channel and blood flow in the blood collection channel within said assembly;

[0068] Fig. 25 is an enlarged sectional view of the catheter tip and the micro-lumen shown in Fig. 24, showing the micro-lumen tip protruding beyond the catheter tip;

[0069] Fig. 26 is a transparent top view of the transfer valve housing of Fig. 16 in an infusion/non-collection mode and showing intravenous flow in all channels;

[0070] Fig. 27 is a translucent sectional view of the transfer valve housing of Fig. 26 taken along section line 27-27 and showing the infusion/non-collection mode;

[0071] Fig. 28 is a translucent top view of the transfer valve housing of Fig. 16 in an infusion/collection mode and showing intravenous flow in the intravenous channel and blood flow in the blood collection channel;

[0072] Fig. 29 is a translucent sectional view of the transfer valve housing shown in Fig. 28 taken along section line 29-29 and showing the infusion/collection mode;

[0073] Fig. 30A is a cross-sectional view of the needle-free outlet passage of the device shown in Fig. 11 taken along section line 30A-30A shown in Fig. 31A with the device in an infusion/non-collection mode;

[0074] Fig. 30B is a cross-sectional view of a needle-free outlet passage connected to a needle-free outlet nozzle of the device shown in Fig. 11, taken along section line 30A-30A shown in Fig. 31A, with the device in an infusion/collection mode;

[0075] Fig. 31A is a bottom view in the axial direction of the needle-free outlet nozzle of the device shown in Fig. 11 when the device is in the infusion/non-collection mode;

[0076] Fig. 31B is a bottom view in the axial direction of a needle-free outlet passage connected to the needle-free outlet nozzle of the device shown in Fig. 11 when the device is in the infusion/collection mode;

[0077] Fig. 32 is a perspective view of a third illustrative embodiment of a blood infusion and collection device used with an intravenous infusion line and a peripheral venous catheter;

[0078] Fig. 33 is a perspective and exploded view of the device shown in Fig. 32;

[0079] Fig. 34 is a sectional view of the valve body and separated tube holder taken along section line 34-34 shown in Fig. 32 with the device in the infusion/non-collection mode;

[0080] Fig. 35 is a sectional view of the valve body and separated tube holder taken along section line 35-35 shown in Fig. 32 with the device in the infusion/non-collection mode;

[0081] Fig. 36 is a sectional view of the valve body and connected tube holder taken along section line 34-34 shown in Fig. 32 with the device in the infusion/collection mode;

[0082] Fig. 37 is a sectional view of the valve body and connected tube holder taken along section line 35-35 shown in Fig. 32 with the device in the infusion/collection mode;

[0083] Fig. 38 is a side view of the outlet needle of the blood infusion and collection device shown in Fig. 32;

[0084] Fig. 39 is a perspective view of the outlet needle of the blood infusion and collection device shown in Fig. 32;

[0085] Fig. 40 is an end view of the outlet needle of the blood infusion and collection device shown in Fig. 32;

[0086] Fig. 41 is a perspective view of the partitions of the blood infusion and collection device shown in Fig. 32;

[0087] Fig. 42 is a side view of the partition of the blood infusion and collection device shown in Fig. 32;

[0088] Fig. 43 is a cross-sectional view of the partition of the blood infusion and collection device shown in Fig. 32;

[0089] Fig. 44 is an end view of the partition of the blood infusion and collection device shown in Fig. 32;

[0090] Fig. 45 is a perspective view from below and from the front of the bypass valve of the blood infusion and collection device shown in Fig. 32;

[0091] Fig. 46 is a perspective view from below and behind the bypass valve of the blood infusion and collection device shown in Fig. 32;

[0092] Fig. 47 shows a sectional view of the valve body taken along section line 34-34 shown in Fig. 32;

[0093] Fig. 48 is a sectional view of the valve body taken along section line 48-48 shown in Fig. 35 with the device in the infusion/non-collection mode;

[0094] Fig. 49 is a sectional view of the valve body taken along section line 48-48 shown in Fig. 35 with the device in the infusion/collection mode;

[0095] Fig. 50 is a sectional view of the valve body, luer lock, catheter and catheter head taken along section line 34-34 shown in Fig. 32;

[0096] Fig. 51 is a sectional view of the valve body shown in Fig. 50 and having a micro-lumen formed along section line 34-34 shown in Fig. 32; and

[0097] Fig. 52 is an end view of the valve housing of the blood infusion and collection device shown in Fig. 32.

DETAILED DESCRIPTION OF ILLUSTRATIVE OPTIONS

IMPLEMENTATIONS

[0098] For an understanding of the operating principles of the invention, reference will be made to one or more embodiments, which may or may not be illustrated in the drawings, and specific language will be used to describe them. However, it will be understood that no limitation of the scope of the invention is intended; any changes and further modifications of the described or illustrated embodiments and any further applications of the operating principles of the illustrated embodiments of the invention are suggested as are generally apparent to those skilled in the art to which the invention pertains. At least one embodiment of the invention is shown in great detail, although it will be understood by those skilled in the art that some features or some combinations of features may not be shown for the sake of clarity.

[0099] Any reference to "invention" herein is a reference to an embodiment of a group of inventions, and no embodiment includes features that are necessarily included in all embodiments unless otherwise indicated. Furthermore, although useful results or advantages provided by some embodiments may be indicated, other embodiments may not have the same results or advantages or may have different results or advantages. Any useful results or advantages described herein should not be construed as limiting any claim.

[0100] Similarly, it is possible to describe "objectives" associated with some embodiments of the present invention, with the understanding that other embodiments may not be associated with these objectives or may include different objectives. Any advantages, objectives, or similar language stated herein should not be construed as limiting any claim. The use of words indicating preference, such as "preferably," refers to features and aspects that are present in at least one embodiment, but are optional for some embodiments.

[0101] Specific quantities (spatial dimensions, temperatures, pressures, times, forces, resistances, currents, voltages, concentrations, wavelengths, frequencies, heat transfer coefficients, dimensionless parameters, etc.) may be explicitly or implicitly stated in this document, but such specific quantities are provided only as examples and are approximate values unless otherwise stated. Portions of the description that refer to specific compositions of matter, if present, are provided only as examples and do not limit the possibility of using other compositions of matter, especially other compositions of matter with similar properties, unless otherwise stated.

[0102] Fig. 1-10 in the drawing section shows a first illustrative embodiment of a blood infusion and collection device, system and/or methods 100 according to the present invention. The device 100 is illustratively shown as being used such that it is connected between a standard intravenous infusion line 10 and a standard catheter 20, such as a peripheral venous catheter placed in a vein of the arm or hand of a patient. An example of such a standard catheter 20 is a shielded intravenous catheter 381534, also known by the trade name "BD Insyte Autoguard Winged 20-gauge catheter", manufactured by Becton, Dickson and Company (BD), Sandy, Utah.

[0103] It will be appreciated that in a typical situation requiring venous catheterization of a patient, such as in an emergency department or hospital, the intravenous infusion line 10 and the catheter 20 will be directly connected via a removable flow connector, typically a luer lock connector having a male portion (not shown) at the proximal end 24 of the catheter 20 and a female connector portion 11 at the proximal end 12 of the intravenous infusion line. The intravenous infusion line 10 is typically connected at the opposite, distal end to an intravenous therapy bag (not shown) and/or an infusion pump (not shown), and the distal end 22 of the catheter 20 is inserted into a blood vessel of the patient, such as into the arm or hand of the patient, as shown in Fig. 1 and 2A-2C, for example, by means of a sharp introducer for inserting a needle (not shown), the needle of which passes through the distal end 22 of the catheter 20 and passes beyond it, and is withdrawn from the catheter after the distal end is placed in the vein 23 of the patient. An example of such an introducer is article 384010, also known as BD Introsyte Autoguard Shielded Introducer, manufactured by Becton, Dickson and Company (BD), Sandy, Utah. After the catheter 20 is placed, the infusion and blood collection device 100 according to the present invention is simply installed between the intravenous infusion line 10 and the catheter 20 with connection using connectors 11 and 65, as described below.

[0104] An exemplary embodiment of a blood infusion and collection device 100 according to the present invention comprises the following main components, shown in Figs. 1, 3 and 6: a collection tube holder 30 designed to accommodate a standard vacuum collection tube 15, a valve body 40, a closing valve 80 and having an inlet 43 for intravenous infusion and a head 63 for a catheter, a rim 70 for connecting the tube holder 30 to the valve body 40 and additional retaining supports 90 for securing the intravenous infusion line 10 and the valve body 40 on the patient's arm.

[0105] Materials from which the test tube holder 30, the valve body 40, the rim 70, the valve 80 and the holding supports 90 can be made include, for example, medical grade plastics and engineering polymers such as acrylonitrile butadiene styrene, polyurethane, polycarbonate, polyethylene terephthalate, polyetherimide, polyetheretherketone, polypropylene, polyethylene terephthalate and the like. For example, the test tube holder 30, the valve body 40 and the rim 70 can be made of polycarbonate, and the valve 80 can be made of polypropylene.

[0106] The inlet 43 for intravenous infusion comprises a separate or integral male connector 42 for fluid connection with a female connector 11, for example a luer lock attachment, of the intravenous infusion line 10. The head 63 for the catheter comprises a female connector 65, for example a luer lock attachment, for fluid connection with the catheter 20. The head 63 for the catheter also comprises a microlumen 60 for intravenous infusion, which is fluidly connected to the channel 58 for intravenous infusion, and a channel 54 for collecting blood, the outlet 64 of which is fluidly connected to the catheter 20 (Fig. 6 and 1C).

[0107] Fig. 2A-2C schematically shows an exemplary fluid system 101 of the device 100 according to the present invention. With reference to the device 100, the blood collection channel 54 and the infusion channel 58 extend between the intravenous inlet 43 and the catheter head 63. As described above, the catheter head 63 is connected to an intravenous catheter 20 that has previously been placed in a peripheral vein 23 of a patient, wherein the catheter head 63 also comprises a micro-lumen 60. After connecting the catheter head 63 to the connector 24 of the catheter 20, the micro-lumen 60 is introduced coaxially into the interior of the catheter 20. For reasons described in more detail below, the relative lengths of the catheter 20 and the micro-lumen 60 are such that the distal end 62 of the micro-lumen 60 extends from the distal end 22 of the catheter 20 and extends beyond it, thus extending axially further along and inside the vein 23 of the patient, as shown in Fig. 2C. The micro-lumen 60 is in fluid communication with the infusion port 58. The catheter 20, or more particularly for the device 100, the radial space between the outer surface of the micro-lumen 60 and the inner surface of the catheter 20 is in fluid communication with the blood collection port 54 through the outlet 64 (Figs. 6 and 7C). It has been found that a micro-lumen 60 having at least a minimum stiffness, yet sufficiently flexible to be securely retained in the catheter 20 and the vein 23, provides an advantage when inserting the micro-lumen 60 into the connector 24 and the catheter 20. For example, a micro-lumen made of unbraided and uncoated polyimide has been found to have acceptable performance. As another example, a micro-lumen made of unbraided and uncoated polyimide, such as product code 165-111 available from Microlumen of Oldsmar, Florida, has been found to have acceptable performance. And in another example, a micro-lumen made of braided and coated (or uncoated) polyimide can also have acceptable parameters.

[0108] Advantageously, the device 100 provides selective operation in an infusion/non-collection mode and in an infusion/collection mode. As shown in Fig. 2A, in the infusion/non-collection mode, intravenous fluid 14 (i.e., any fluid entering the body) is supplied simultaneously from the intravenous inlet 43 to each of the infusion channel 58, including the microlumen 20, and the blood collection channel 54, including the catheter 20, of the fluid system 101. In the infusion/non-collection mode, intravenous fluid 14 flows into the fluid system through the intravenous inlet 43 and simultaneously enters the vein 23 at the respective distal ends 22 and 62 of the catheter 20 and the microlumen 60.

[0109] In contrast, as shown in Figs. 2B and 2C, in the infusion/collection mode, the blood collection channel 54 of the device 100 is blocked from the intravenous inlet 43 and thus from the supply of intravenous fluid 14. The isolation of the fluid in the intravenous inlet 43 from the blood channel 54 may be accomplished by any of various mechanical or electromechanical drive means known in the art. For example, in the illustrative first embodiment of the device 100, the three-way (including one selectively sealed outlet passage 81) two-way rotary valve 80 (Fig. 3) is rotated from a non-collecting position 83a, in which the valve passage 84a (Figs. 2A and 7C) is in fluid communication with both the intravenous inlet 43 and the blood channel 54, to a collecting position 83b, in which the valve passage 84a (Figs. 2B and 9C) is fluidly isolated from the intravenous inlet 43, but remains fluidly connected to the blood channel 54. Thus, the valve passage 84a forms part of the blood collection channel 54 in the valve position 83b. As used herein, the expression "actuating means", of which "valve" is an example, refers to a means that acts on a fluid flow, such as to start, stop, or otherwise regulate the flow of fluid.

[0110] As shown in Fig. 2B, when the blood collection channel 54 is blocked from the intravenous fluid 14, the vacuum blood collection tube is in fluid communication with the blood collection channel 54 through an outlet, such as the needle channel 84b. Due to the vacuum in the collection tube 15, blood 18 is collected into the catheter 20, or more precisely from the space between the catheter 20 and the micro-lumen 60, as shown in Fig. 2C, through the blood collection channel 54 and into the collection tube 15. The blood 18 is collected simultaneously and without interrupting the infusion of the intravenous therapy fluid 14 through the infusion channel 58 with an outlet into the vein 23 of the patient at the distal end 62 of the micro-lumen 60.

[0111] As blood 18 is drawn from vein 23 into catheter 20, the fluid entering collection tube 15 will initially be intravenous fluid 14, then a mixture of intravenous fluid 14 and blood 18, and only then blood 18. Thus, the first collection tube 15 filled from blood collection channel 54 is discarded, and the next blood collection tube 15 to be filled, containing only blood 18 without intravenous fluid 14, remains. After receiving a sufficient portion of blood 18 from the device 100, the collection tube 15 is fluidly disconnected from the blood collection channel 54, and if necessary, further collection tubes 15 are connected, filled and disconnected, and then the rotary valve 80 is returned to the non-collecting position 83a, resuming the fluid communication of the blood collection channel 54 with the therapeutic fluid 14 from the intravenous inlet 43, thereby again providing the infusion/non-collection mode shown in Fig. 2A, in which the intravenous fluid 14 is simultaneously supplied both through the catheter 20 and through the microlumen 60.

[0112] In Fig. 2C, the distal end 62 of the micro-lumen 60 extends further from the distal end 22 of the catheter 20. The length of the distal portion 62 of the micro-lumen 60 extending from the distal end 22 of the catheter 20 is illustratively approximately 10 mm, but may vary depending on various hydrodynamic characteristics of the device 100, including the type and model of the catheter 20 and the micro-lumen 62 used, as well as the desired flow rate during blood collection. The length of the protruding portion and the flow rate during blood collection are essential to the present invention to prevent mixing at the distal end 22 and thus contamination of the withdrawn blood 18 with intravenous fluids 14, as will become clear from the following description. For example, a typical 20 gauge intravenous catheter is 18 or 20 gauge, and a 60 gauge microlumen that provides the required functionality when inserted axially into a 20 gauge catheter is 24 to 25 gauge.

[0113] Fig. 3 illustrates an exploded perspective view of the valve body 40. The valve body 40 has an upper portion 44 and a lower portion 45 that together define a valve cavity 50, portions 58a and 58b of the intravenous infusion channel and a blood collection channel 54. The valve body 40 provides a continuous flow communication through the infusion channel 58a, thus providing a continuous supply of intravenous fluid 14 present in the intravenous inlet 43 to both the outlet 64 and the microlumen 60. A rotary valve 80 is sealed in the valve cavity 50, which, in the non-collecting mode, provides selective supply of intravenous fluid 14 to the blood collection channel 54. For example, the valve element 82 may comprise a sealing lip or other element 85 that prevents leakage of liquids, and the valve element 82 and/or the valve cavity 50 may be coated with a sealing and/or lubricating material prior to assembly, such as a silicone spray or gel, or may comprise an elastomeric sealing layer.

[0114] The rotary valve 80 comprises a valve member 82 which defines a valve passage 84a having openings connected to opposite sides of the valve body (Fig. 3 and 7C). The valve member 82 also defines an outlet passage 81 which is flow-sealed by means of a partition 76 and holds it (Fig. 3), and tube holder interaction elements 86, 87 which are described below.

[0115] The outlet passage 81 at the lower portion 77 of the septum 76 is in fluid communication with the passage 84a of the valve through the channel 84b of the needle (Fig. 7B). As shown in Figs. 7B and 7C, when the valve 80 is contained within the assembled upper portion 44 of the housing and the lower portion 45 of the housing, and the valve 80 is in the non-collecting position 83a (Fig. 7C), the passage 84a of the valve 80 provides a fluid communication between the portion 58b of the infusion channel and the blood collection channel 54, providing the supply of intravenous fluid 14 to the catheter head 63 and the catheter 20. As shown in Fig. 9C, when the valve 80 is rotated to the collection position 83b, the passage 84a of the valve 80 is fluidly isolated from the portion 58b of the infusion channel, but remains in fluid communication with the blood collection channel 54, thus providing a path for the blood 18 entering the distal end 22 of the catheter 20 to the passages 84a of the valve, the channel 84b of the needle and the lower portion 77 of the septum 76.

[0116] As shown in Fig. 4, the collection tube holder 30 provides an adapter for connecting the blood collection tube 15 to the valve body 40, and is operative to actuate the valve 80 between a non-collecting position 83a (Fig. 8C) for the infusion/non-collection mode and a position 83b (Fig. 9C) for the infusion/collection mode. The tube holder 30 comprises a handle 31 for insertion and rotation, a central receiving member 32, a tube stop 33 at the base of the receiving member, a mating portion 36 of the outlet passage, and an outlet needle 34. As shown in Fig. 7B, the withdrawal needle 34 passes through the limiter 33 of the tube and has an upper end 34a that passes over the limiter 33 and upward into the receiving element 32. The withdrawal needle 34 also passes downward under the limiter 33 and inside the central part 39, closed by the mating part 36 of the withdrawal passage. The mating part 36 of the withdrawal passage partially serves to surround and prevent injury from the sharp lower end 34b of the needle 34.

[0117] The mating portion 36 of the tube holder is configured to be mounted inside the opening 46 in the valve body 40 and to interact with the valve 80 and the body 40 when the tube holder 30 and the rim 70 are connected to the valve body 40. In the first illustrative embodiment of the device 100, when the tube holder 30 is connected to the valve body 40 and the valve 80, the axial position of the withdrawal needle 34 and the rotation of the valve 80 are ensured. In particular, the connection extends in the axial direction of the withdrawal needle 34 through the lower part 77 of the septum and the channel 84b of the needle and into the passage 84a of the valve, as shown in Fig. 9B. In addition, the connection allows the valve 80 and the valve body 40 to be rotated from the infusion/non-collection position 83a to the infusion/collection position 83b. Additionally, mechanical elements may be provided in the tube holder 30, housing 40, and/or valve 80 such that mechanical locks or other sensory feedback are provided indicating the range of full rotation and/or axial transmission limits to ensure proper use and operation.

[0118] As shown in Fig. 3, 4 and 7B, the mating portion 36 of the test tube holder forms various interaction elements, including axial output projections 37, rotary grooves 38 and a central portion 39. The valve body 40 forms various interaction elements, including an opening 46, receiving portions 47 for output projections and output platforms 48. The valve 80 forms various interaction elements, including a receiving portion 86 and rotary projections 37. The operation and interaction of the various interaction elements are described below in the operation of the device 100.

[0119] Figs. 7A-7C, 8A-8C, 9A-9C, and 10A-10C illustrate various stages and phases of operation in the infusion/non-collection mode, preparing the device 100 for blood withdrawal, withdrawing blood into the collection tube(s) 15 in the infusion/collection mode, and returning the device 100 to the infusion/non-collection mode.

[0120] As shown in Fig. 7A, in the following illustrative example of using the illustrative device 100, the installation of the device 100 for infusion and collection of blood for intravenous therapy of a patient is described. Before installing the device 100, following standard techniques known in the art, a peripheral venous catheter 20 is typically inserted into a vein of the patient, and the intravenous therapy tube 10 is connected using a Luer or other type of connection 11. To install the device 100 for infusion and collection of blood in line with the catheter 20 for periodically removing clean blood samples from the patient through the catheter 20, the flow 14 of the intravenous therapy fluid through the intravenous infusion line 10 is stopped, and the peripheral venous catheter 20 is disconnected from the intravenous infusion line 10. The valve body 40 of the device is connected to the intravenous infusion line 10 by connecting the connector 11 to the inlet 43, after which the flow 14 of fluid is resumed along the line 10, so that the intravenous fluid 14 (or, for example, heparin) entering the inlet passage 43 fills both the blood collection channel 54 and the infusion channel 58 in the body 40, until the intravenous fluid 14 flows out of the catheter head 63, thereby displacing all air from the channels 54 and 58. The protective cap 96 (Fig. 5) can be removed from the catheter head 63, opening the microlumen 60, for example, by activating the trigger 98.

[0121] The catheter head 63 can then be connected to the catheter 20 (which, for example, remains in the patient's body) by inserting the micro-lumen 60 through the catheter 20 and tightening the luer or other type connector 65 onto the male connector 63 of the catheter, which allows the infusion of the intravenous therapy fluid 14 into the patient's body from both the catheter 20 and the micro-lumen 60. Advantageously, the valve body 40 can be grasped from above and held in the palm of the hand while actuating the trigger 98, while the micro-lumen 60 is guided and rotated by the connector 65 with the help of the wing 66 of the free thumb and/or index finger of the hand holding the valve body 40, freeing the other hand to apply pressure to the vein 23 to prevent blood flow through the catheter 20 from the moment the intravenous line connector 11 is disconnected until the moment the connector is connected 65 of the device 100. When further connecting the retaining supports 90 in the clamps 92 with the receiving elements 94 of the valve body (Fig. 3), as shown in Fig. 1, a medical tape can be applied to the surface 91 and around the patient's hand to hold the valve body 40 in place. Advantageously, the valve body 40 can have ribs or other projections formed by the lower part 45 of the body to limit contact with the skin or the risk of tearing the skin. In addition, to ensure drainage of any liquids entering the opening 46 when the tube holder 30 is not installed in place, and to minimize the risk of microorganism growth, discharge channels 51 can be formed in the body 40, extending downwards from the interior of the opening 46.

[0122] As an option and advantage, the device 100 can also be installed in line with the catheter 20 when the catheter 20 is first deployed and before the intravenous infusion line 10 is connected to the catheter 20. For example, as described above, the device 100 can be connected to the intravenous infusion line 10 and purged of air using the intravenous fluid 14. Then, when the device 100 is prepared, the peripheral venous catheter 20 can be inserted into the patient's vein, and the catheter head 63 is connected to the catheter 20, as described above.

[0123] In Figs. 7A-7C, the device 100 is shown in the infusion/non-collection mode after being installed in line with the intravenous infusion line 10 and the catheter 20. In particular, the tube holder 30 and the rim 70 are disconnected from the valve body 40, and the rotary valve 80 is in the infusion/non-collection rotary position 83a (Fig. 7C), in which the intravenous fluid 14 supplied through the inlet 43 simultaneously passes into both the blood collection channel 54 and the infusion channel 58a and, thus, simultaneously flows into the patient's vein 23 from the catheter 20 and from the micro-lumen 60.

[0124] To prepare the device 100 for the infusion/collection mode, an alcohol or other sterilizing swab is used to clean the septum 76 and the area inside the opening 46 to remove any contaminants. Then, the tube holder 30 without the blood collection tube 15 attached is connected to the valve body 40. In particular, the axial outlet projections 37 are pivotally aligned with the receiving portions 47 for the outlet projections and the tube holder 30 is moved vertically downward in the direction shown in Figs. 7A and 7B, passing the projections 37 through the receiving portions 47 and into the outlet platforms 48 and with the engagement of the side flanges 72 around the valve body 40. The rim 70 and the tube holder 30 are detachably retained on the valve body 40 by the engagement of the projections 71 with the recesses 41 located on each side of the valve body 40. In addition, as shown in Fig. 8B and 8C, in this position, the lower end 34b of the withdrawal needle 34 does not penetrate the septum 76, and the rotary valve 80 remains in the rotary infusion/non-collection position 83a. As shown in Fig. 8A, the flanges 72 can form friction elements, such as ridges, to ensure that the device 100 is securely held during subsequent steps.

[0125] To complete the axial movement of the lower end 34b of the withdrawal needle 34 through the partition 76 and into the passage of the valve 84a of the valve, the tube holder 30 is rotated clockwise relative to the valve housing 40, as shown in Fig. 8A. With reference to Figs. 9B and 9C, which show the device 100 with the rotation completed, the rotation of the tube holder 30 causes the withdrawal projections 37 to rotate inside the withdrawal pads 48 of the housing 40. The withdrawal pads 48 are made in a downward spiral, so that as a result of the rotation, the mating part 36 of the tube holder moves in the axial direction downwardly further into the valve housing 40 to the position shown in Fig. 9B, in which the lower end 34b of the withdrawal needle 34 pierces the partition 76 and passes into the passage 84a of the valve. In addition, the rotation of the mating part 36 with the tube holder 30 provides for the rotation of the valve 80, since the ridges 87 are located inside the grooves 38 of the mating part 36. This rotation provides for the rotation of the valve 80 into the infusion/collection position 83b shown in Fig. 9C, in which the passage 84a (Fig. 2B and 9C) is fluidly isolated from the intravenous inlet 43, but remains fluidly connected to the blood channel 54. Mechanical stops (not shown), for example, the ends of the outlet pads 48, which are in contact with the outlet projections 37, prevent excessive rotation of the valve 80 clockwise and counterclockwise.

[0126] Additionally, the initial length of the terminal pads 48 formed in the valve body 40 and engaged with the terminal projections 37 may extend circumferentially without axial downward displacement to provide partial or complete rotation of the valve 80 before subsequent axial movement of the mating portion 36 and the needle 34, thus preventing fluid communication between the lower end 34b of the needle and the passage 84a of the valve until the passage 84a of the valve is closed from the portion 58b of the infusion channel and, thus, from the supply of the intravenous fluid 14.

[0127] As shown in Fig. 9A and 9B, after the blood collection channel 54 is closed from the intravenous fluid 14, the evacuated blood collection tube 15 is in fluid communication with the blood collection channel 54 through the needle channel 84b and the valve passage 84a. In particular, when the collection tube is pushed down into the receiving member 32 and toward the stop 33 of the tube holder 30, the septum 16 of the collection tube 15 causes the elastomeric cap 35 of the needle to be pushed down, exposing the upper end 34a of the needle and allowing this end to puncture the septum 16 of the collection tube. The vacuum in the collection tube 15 causes the blood 18 to be removed into the catheter 20, as shown in Fig. 2C, through channel 54 for blood collection, passage 84a of valve, needle 34 and into collection tube 15.

[0128] Preferably, the collection of blood 18 occurs simultaneously with and without interruption of the infusion of intravenous therapy fluid 14 through infusion channel 58 with an outlet into the patient's vein 23 at the distal end 62 of microlumen 60. Collection tube 15 is disconnected from holder 30 and, if necessary, subsequent tubes 15 are attached, filled and disconnected. Due to the lack of vacuum of passive fluid flow restriction provided by needle 34 and elastomeric cap 35 re-sealing upper end 34a of needle 34, the passage of blood 18 through needle 34 will be restricted in the absence of tube 15 in place. For example, flow restriction can be provided by a selected internal diameter of needle 34, as described below, by crimping needle 34 to a certain required cross-sectional area, or other mechanically passive means known in the art for flow restriction.

[0129] To return the device 100 to the infusion/non-collection mode, as shown in Figs. 10B and 10C, the tube holder 30 is rotated counterclockwise and the rim 70 and the tube holder 30 are separated from the valve housing 40, as shown in Fig. 10A. Rotating the tube holder 30 counterclockwise returns the rotary valve 80 to the non-collection position 83a, allowing the blood collection channel 54 to resume flow communication with the therapy fluid 14 from the intravenous inlet 43.

[0130] When the tube holder 30 is rotated counterclockwise, the mating portion 36 and the needle 34 also move axially upward, since the output projections 37 are arranged in a spiral upward within the output pads 48. When the output projections 37 are again aligned with the pads 47, the rotation is completed, and the mating portion 36 can be completely withdrawn from the opening 46, and the flanges 72 are withdrawn from the valve body 40, as shown in Fig. 10B. Advantageously, the septum 76 is self-sealing, so that when the needle 34 is removed, the intravenous fluid 14 flows through the valve passage 84a without leaking through the septum 76.

[0131] Again in the infusion/non-collection mode shown in Fig. 10C, the intravenous fluid 14 is simultaneously supplied to both the catheter 20 and the micro-lumen 60, ensuring the flushing of the blood collection channel 54 from the blood 18 previously removed through it, ensuring further use of the device 100. Thus, advantageously, the blood collection channel 54, including the valve passage 84a, is self-flushing, since when returning to the infusion/non-collection mode, all remaining blood is washed out through the catheter 20 with the flow of intravenous fluid 14, thereby preventing any coagulation and potential blockage or other dangers associated with the blood 18, when using the device 100. Since the withdrawal needle 34 associated with the tube holder 30 is not flushed, it is discarded, and if it is necessary to re-extract blood from the patient, a new tube holder 30 is used.

[0132] One aspect of the first embodiment of the invention relates to one of the novel features of the blood infusion and collection device 100 and the corresponding method, which consists in the ability to perform clean blood collections while simultaneously providing an intravenous therapeutic infusion to a patient without interrupting the flow of intravenous fluid. In one aspect, the device 100 is configured to prevent contamination of the withdrawn blood 18 with intravenous fluids 14. The ability of the device 100 to provide this function is partially due to two features of the device: 1) the passage of the tip of the micro-lumen 60 into the vein 23 an optimally minimal distance beyond the tip of the catheter 20 (see Fig. 2C); 2) a corresponding flow restriction in the collected blood 18 when the rotary valve 80 is rotated to the collection position 83b.

[0133] In an illustrative embodiment with the above features, for example, the distal tip 62 of the micro-lumen 60 extends 10 mm beyond the distal tip 22 of the catheter 20, in combination with the restriction of the blood collection channel 54 to reduce the flow rate for collecting blood to 30 ml/min or less, provides sufficient protection against intravenous fluids 14 flowing out of the distal tip 62 of the micro-lumen 60 from entering and mixing with the blood 18 entering the distal tip 22 of the catheter 20 for collection into the tube 15.

[0134] As provided herein, it should be understood that the length by which the tip of the micro-lumen protrudes relative to the tip of the catheter and the degree of restriction of the blood flow 18 can be varied up or down depending on various factors such as, for example, the particular caliber of the catheters 20 and 60 used, the vacuum pressure in a particular collection tube 15, the venous or arterial location of the catheter 20 in the patient and the rate of infusion of the intravenous therapy fluid 14 through the micro-lumen 60. Thus, for example, when protruding by a length of less than 10 mm, the flow rate should be accordingly further restricted and reduced, and when protruding by a length of more than 10 mm, the flow rate can be accordingly increased.

[0135] With respect to the restriction of the blood flow 18 to reduce the flow rate during blood collection to such an extent that the flow of intravenous fluid does not change in the vein and enters the blood collection catheter, this restriction can be accomplished in various ways known in the art and at various locations along the path of the blood flow 18 between the distal end 22 of the catheter 20 and the blood collection tube 15, either by an active restriction means, or a passive restriction means, or a combination of active and passive restriction means. In the above illustrative embodiment of the device 100, the flow rate limitation is accomplished passively by selecting the internal diameter and the length of the needle 34 passing into the end of the collection tube, wherein the needle is selected with a sufficiently small internal diameter to provide the desired restriction of the blood flow rate. In an exemplary device 100, in which the distal end 62 of the micro-lumen 60 extends 10 mm beyond the distal end 22 of the catheter 20, limiting the flow rate to about 30 ml/min ensures the desired absence of contamination of the collected blood sample. This desired limitation is passively ensured by using a piercing needle 34 having a gauge of about 24, for example, with an internal diameter of about 0.3 mm (0.012 inches). For example, such a needle 34 can be cut from a length of round 304 stainless steel hypodermic tubing, such as article number B00137QIWS, available from Amazon.com, LLC, Seattle, Washington.

[0136] The volumetric flow rate (Q) of the blood 18 is determined by the change in pressure (ΔP) for the blood 18 between the patient and the collection tube 15, and in particular, in the exemplary embodiment of the device 110, at the point of passive restriction of the blood 18 flow, in the outlet needle 34. To determine the gauge of the needle that will limit the volumetric flow rate (Q) to a desired value, for example, about 30 ml/min or less for the exemplary embodiment, it is possible to use the principles of fluid dynamics for laminar flow with an applied force and a boundary condition of no slip between the desired volumetric flow rate (Q) and the pressure gradient (ΔP). This relationship is represented in the Hagen-Poiseuille equation, which is given by: where a, L, p, μ are, in this example, the inner radius and length of the needle 136, as well as the density and viscosity of the blood, respectively.

[0137] Fig. 11 and 13 in the drawing section show a perspective view of a second illustrative embodiment of an illustrative blood infusion and collection device 110 according to the present invention, illustratively installed between a standard intravenous infusion line 10 and a standard catheter 20, such as a peripheral venous catheter. An example of such a standard catheter 20 is a shielded intravenous catheter 381703, also known as a BD Angiocath Autoguard 20 gauge manufactured by Becton, Dickson and Company (BD), Sandy, Utah.

[0138] An exemplary embodiment of a blood infusion and collection device 110 according to the present invention comprises the following main components, shown in Fig. 11. A tube holder 120 for receiving a standard vacuum collection tube 15, a transfer valve and a collection housing 140, an intravenous infusion inlet 143 (Fig. 12) for fluid communication with the intravenous infusion line 10, a blood collection lumen 150, an intravenous infusion lumen 160, and a catheter head assembly 200 for fluid communication with the catheter 20. The blood collection lumen 150 and the intravenous infusion lumen 160 connect the catheter head assembly 200 to the transfer valve and the collection housing 140.

[0139] Fig. 12 shows the tube holder 120, the vacuum collection tube 15, the transfer valve and the collection body 140 assembled together, and Fig. 13 shows the catheter head assembly 200, which includes a catheter head body 202. The distal end of the catheter head body 202 includes a connector 204 for connecting to the connector 83 (Fig. 23) on the proximal end 24 of the standard venous catheter 20. In addition, the assembly 200 includes an attached micro-lumen 210, which extends coaxially through the interior of the catheter 20.

[0140] The catheter head housing 202 provides fluid communication between the micro-lumen 210 and the blood collection lumen 150 and between the catheter 20 and the intravenous infusion lumen 160. Fig. 23 shows a side section of the assembly 200 and illustrates internal passages 250 and 260 defined by the housing 202. The blood collection passage 250 supports the blood collection lumen 150 and the catheter 20 and is in fluid communication with them, or more precisely, with the open space between the interior of the catheter 20 and the exterior of the micro-lumen 210. The infusion passage 260 supports the intravenous infusion lumen 160 and the micro-lumen 210 and is in fluid communication with them.

[0141] The blood collection channel is partially formed by a passage defined by the space between the catheter 20 and the micro-lumen 210, the passage 250 and the lumen 150. The infusion channel is partially formed by the micro-lumen 210, the passage 260 and the lumen 160. As discussed in more detail below, the blood collection channel 152 is used to provide an infusion flow to the patient when the device 110 is in the infusion/non-collection mode, and, as discussed below, for a reverse flow of blood 18 from the patient to the collection tube 15 when the device 110 is in the infusion/collection mode. On the other hand, the infusion channel 162 is used in any mode only for a one-way infusion flow to the patient, as discussed below.

[0142] Fig. 23-25 shows the distal end 212 of the micro-lumen 210 extending further from the distal end 22 of the catheter 20. Fig. 25 shows an enlarged partial view of a portion 22 of the distal end of the catheter 20 and more clearly illustrates the protruding distal portion 212 of the micro-lumen 210. The length of the distal portion 212 of the micro-lumen 210 that extends from the distal end 22 of the catheter 20 is illustratively about 10 mm, but may vary depending on the type and model of the catheter 20 used and the desired flow rate during blood collection. The length of the protrusion and the flow rate during blood collection are essential to the present invention to prevent mixing and thus contamination of the withdrawn blood 18 with intravenous fluids 14, as will become clear from the following description. For example, a commonly used 20 gauge catheter is 18 or 20 gauge, which provides a flow rate of about 65-100 ml/min, although the flow rate will vary with changes in internal diameter. A 210 micro lumen that provides the required functionality when inserted axially into a 20 gauge catheter is 25 to 26 gauge.

[0143] Fig. 11 and 13 also show a catheter head assembly 200 comprising a micro-lumen stabilization traction handle 206 (not shown in the views shown in Fig. 23 and 24). The traction handle 206 is connected to a wire or pin (not shown) that is inserted through the interior of the micro-lumen 210, providing rigidity to the micro-lumen 210 and the catheter 20 for inserting the respective distal ends 212 and 22 into the patient's body. After successful insertion into the patient's body, the traction handle 206 is actuated approximately along its axis, thereby providing for the withdrawal of the wire or pin (not shown) from the interior of the micro-lumen 210, reducing the rigidity. It is understood that the technique for inserting the catheter may correspond to a standard technique for inserting a catheter, well known in the art.

[0144] Referring again to Fig. 12, a close-up perspective view of the assembled tube holder 120, the vacuum collection tube 15, the transfer valve, and the collection housing 140 is illustrated. Figs. 14 and 15 show the transfer valve and the collection housing 140, the tube holder 120, respectively, separated from each other. Fig. 15 shows a perspective view of the tube holder 120 from below. The transfer valve and the collection housing 140 are enclosed in a transfer valve housing 142 (see Fig. 16 below) comprising a valve assembly 180 (partially shown in Fig. 19 and discussed in more detail below) and a locking mating portion with keyholes 141a and retaining flanges 141b for accommodating and retaining the tube holder 120 relative to the valve assembly 180. In particular, retaining wings 122 (Fig. 15) protruding radially from the receiving member 124 of the drive means on the lower part of the tube holder 120 pass through the keyholes 141a, and when the tube holder 120 is rotated relative to the transfer valve and the collection housing 140, the retaining wings 122 rotate under the retaining flanges 141b to firmly retain the tube holder 120 with the transfer valve and body 140 for collection.

[0145] As shown in Figs. 14, 19, 22, 27 and 29, the valve assembly 180 comprises a rotary valve 182, a valve actuator 184, an elastomeric valve layer 190 and a portion of an upper housing portion 144. The drive means 184 is spaced from the rotary valve 182 and is rotatably fixed with the said valve on the central shaft 181. The elastomeric valve layer 190 and a part of the upper part 144 of the housing are fixed relative to the housing 140 and, thus, their rotation with the rotary valve 182, the drive means 184 and the shaft 181 is prevented. The drive means 184 (Figs. 14 and 16) has an opening containing a receiving element 186 for the locking sleeve, which is designed to be placed with engagement of the locking sleeve 148 (shown in Fig. 17), and also has an elongated arcuate opening containing a receiving element 188 for the mating part of the outlet passage, which is designed to be placed with engagement of the mating part 130 of the outlet passage (Fig. 15) of the test tube holder 120.

[0146] The tube holder 120 also comprises a key 126 for ensuring the locking and an elongated arcuate mating portion 130 of the outlet passage, which are located inside the receiving element 124 of the drive means. The mating portion 130 of the outlet passage is located and has a size to ensure precise installation in the receiving element 188 of the mating portion of the outlet passage when the tube holder 120 is installed on the transfer valve and the housing 140 for collecting. Similarly, the key 126 for ensuring the locking is located and has a size to ensure precise installation in the receiving element 186 for the locking sleeve when the tube holder 120 is installed on the transfer valve and the housing 140 for collecting. The mating portion 130 of the outlet passage also contains a recessed swab 134 with alcohol or another disinfectant and a needle-free outlet nozzle 132.

[0147] Fig. 16 shows a perspective view from above of the transfer valve housing 142 when it is removed from the transfer valve and the housing 140 for assembly. The transfer valve housing 142 includes an upper housing portion 144 and a lower housing portion 145. The transfer valve housing 142 also houses a valve assembly 180, which includes a valve actuator 184 and a rotary valve 182 (not shown in Fig. 16), rigidly held together with a shaft 181, and an upper housing portion 144 and an elastomeric valve layer 190 between them (the valve assembly 180 is discussed in more detail below with reference to Fig. 19). The materials from which the body 142, the test tube holder 120, the drive means 184 and the valve 182 can be made include, for example, engineering polymeric materials such as acrylonitrile butadiene styrene, polyurethane, polycarbonate, polyethylene terephthalate, polyetherimide, polyetheretherketone, polypropylene, polyethylene terephthalate and the like. The materials from which the elastomer layer 190 can be made include, for example, thermoplastic urethane, thermoplastic vulcanizate, polyester block polyamide, thermoplastic polyethylene, adhesive sealant vulcanizing at room temperature, and the like.

[0148] The upper part 144 of the housing has an opening 146 for introducing therethrough the central shaft 181 of the valve assembly and a curved locking console 147, at the distal end of which a locking sleeve 148 is located. The locking sleeve 148 is configured to be connected to a receiving element 186 for the locking sleeve of the actuator 184 of the valve for rotary locking of the valve assembly 180 relative to the housing 142 and the elastomeric valve layer 190. The upper part 144 of the housing also contains a needle-free outlet passage 154, from which the flow 18 of the collected blood is supplied to the tube holder 120 during a certain operating mode described below.

[0149] Fig. 19 shows a valve assembly 180 with an actuator 184, a rotary valve 182 and a shaft 181. As described above, the valve actuator 184 defines a receiving element 186 of the locking sleeve and a receiving element 188 of the mating portion of the outlet passage for the outlet passage. The rotary valve 182 is shown in Fig. 19 and has a transfer channel 183. The valve 182 and the actuator 184 are spaced apart from each other for accurate installation on opposite sides of the upper portion 144 of the housing and the elastomeric valve layer 190, as best illustrated in Fig. 22, 27 and 29, wherein the upper part 144 of the housing is located between the driving means 184 and the elastomeric valve layer 190, wherein the elastomeric valve layer 190 is located between the upper part 144 of the housing and the rotary valve 182, and the rotary valve 182 is located between the elastomeric valve layer 190 and the lower part 145 of the housing. The exact size and arrangement of the various elements on the valve 182, the elastomeric valve layer 190, the driving means 184 and the elements of the upper part 144 of the housing are of significant importance, as described above and below.

[0150] Fig. 18 and the various subsequent drawings show a translucent view of the transfer valve housing 142 comprising fluid passages formed by portions of the upper housing 144, the elastomeric valve layer 190, the rotary valve 182. These fluid passages are in selective fluid communication with the incoming intravenous infusion line 10 via the inlet 143, the infusion lumen 160, the blood collection lumen 150, and the needle-free outlet passage 154. In particular, with reference to Fig. 21 and 28, the blood collection channel 152, partially described above, is also defined by a blood collection passage 194, including a blood collection transfer opening 195, and an outlet passage 154. The blood collection lumen 150, the passage 194, the transfer opening 195, and the outlet passage 154 are always in fluid communication in both modes of operation, namely, in the infusion/non-collection mode shown in Figs. 26-27 and in the infusion/collection mode shown in Figs. 28-29. In addition, the infusion channel 162, partially described above, is also limited by the infusion passage 197, including the infusion transfer port 196. The infusion lumen 160, the passage 197, the transfer port 196, the inlet 143 and the intravenous infusion line 10 are also always in flow communication in both modes of operation.

[0151] In contrast, selective flow communication is provided depending on the rotational position of the valve assembly 180 and the tube holder 120 relative to the housing 142 of the transfer valve. Before mounting the tube holder 120 on the transfer valve and the housing 140 for collection, the rotary valve 182 and the valve actuator 184 are in their extreme counterclockwise position, as shown in Figs. 16 and 26-28. This relative positioning provides an infusion/non-collection mode in which the transfer channel 183, defined by the rotary valve 182, is in the rotational position 183a, best shown in Fig. 27, and also shown in Figs. 20 and 26, so that unimpeded flow communication is provided between the infusion transfer port 196 and the blood collection port 195, the operation of which will be described below.

[0152] After mounting the tube holder 120 on the transfer valve and the collection housing 140, including the full possible clockwise rotation of the tube holder 120, the valve actuator 184 and the rotary valve 182, the infusion/collection mode is ensured, in which the transfer channel 183 is in the rotary position 183b shown in Fig. 21 and 28-29, which provides flow isolation between the infusion transfer port 196 and the blood collection port 195, and thus flow isolation throughout the blood collection channel 152 and the infusion channel 162. In addition, in the infusion/collection mode, the needle-free outlet nozzle 132 is in flow communication with the needle-free outlet passage 154, and thus the blood collection channel 152 in this mode of operation is also limited by the needle-free outlet nozzle 132 and the needle 136 for puncturing the tube.

[0153] The selection between the infusion/non-collection mode and the infusion/collection mode is performed by installing and rotating clockwise, and also by rotating counterclockwise and removing the tube holder 120 from the transfer valve and the collection body 140, including the corresponding function of the various interacting components as a result of installing and rotating.

[0154] When the tube holder 120 is mounted on the transfer valve and the collection body 140, the valve actuator 184 is inserted into the receiver 124 of the actuator (Fig. 15), and the key 126 for ensuring the locking passes downward into the receiver 186 of the locking sleeve from the side opposite to that from which the sleeve 148 of the console 147 passes upward into the receiver 186 of the locking sleeve, ensuring that the sleeve 148 is pressed downward and the receiver 186 of the locking sleeve is released. In addition, when the tube holder 120 is mounted on the transfer valve and the collection body 140, the mating portion 130 of the outlet passage is accurately positioned in the receiver 188 of the mating portion of the outlet passage. To install the tube holder 120 on the transfer valve and the collection body 140, they are connected by installing the mating and retaining elements as described above, and the holder 120 is rotated to attach the retaining wings 122 of the tube holder under the retaining flanges 141b.

[0155] Fig. 22 shows a cross-section of the tube holder 120 and the transfer valve and the collection body 140 assembled together. Fig. 22 also shows a needle 136 for piercing the collection tube connected to the tube holder 120, protruding upward into the central part of the tube receiving member 128, and fluidly communicating with the needle-free outlet nozzle 132. Fig. 22 also illustrates the piercing by the needle 136 of the tube piercing a part of the cap 17 of the collection tube 15, which is inserted in the axial direction into the tube receiving member 128, so that the blood sample 18 can be collected therein. The drawing shows the assembly in a normal mode without blood collection, wherein the needle-free outlet nozzle 132 does not block the needle-free outlet passage 154. In this infusion/non-collection mode, the valve assembly 180 functions to ensure the flow of intravenous fluid 14 entering the inlet 143 from the intravenous infusion line 10, into both channels 152 and 162 and, thus, into both lumens 150 and 160, as shown in Fig. 20, and then passing through both channels through the catheter 20 and the microlumen 210 and into the vein of the patient.

[0156] The following illustrative example of the use of the illustrative device 110 describes the process of installing the device 110 for infusion and collection of blood during intravenous therapy of a patient. Prior to installing the device 110, following standard techniques known in the art, the peripheral venous catheter 20 is typically inserted into a vein of the patient, and the tube 10 for intravenous therapy is connected using a Luer or other type of connection 11. To install the device 110 for infusion and blood collection in preparation for collecting clean blood samples from a patient through the catheter 20, the flow 14 of intravenous therapy fluid through the intravenous infusion line 10 is stopped, and the peripheral venous catheter 20 is disconnected from the line 10. The transfer valve and the housing 140 for collecting the device are connected to the intravenous infusion line 10 by connecting the connector 11 to the inlet passage 143.

[0157] Referring to Figs. 26-27, illustrating the use of the device 110 in the infusion/non-collection mode, the flow 14 of fluid through the line 10 is restarted, and the intravenous fluid 14 (or, for example, heparin) flowing into the inlet passage 143 fills both the blood collection channel 152 and the infusion channel 162 in the housing 142, the lumens 150 and 160, the passages 250 and 260 defined by the catheter head housing 202, until the intravenous fluid 14 flows out of the catheter head assembly 200, thereby displacing all air from the channels 152 and 162.

[0158] The catheter head assembly 200 can then be connected to the catheter 20 (which, for example, remains in the patient's body) by inserting the micro-lumen 210 through the catheter 20 and tightening the luer or other type connector 204 onto the male connector 83, as shown in Fig. 23. The micro-lumen stabilization pull handle 206 is then pulled, retracting the wire or pin from the inside of the micro-lumen 210, and intravenous therapy is resumed, thereby providing an infusion of intravenous therapy fluid 14 into the patient's body from both the catheter 20 and the micro-lumen 210 (not shown in detail).

[0159] The position 183a of the infusion/non-collection transfer channel operates to provide a flow 14 of intravenous fluid from the intravenous infusion line 10 both through the blood collection line/channel 150/152 and through the intravenous infusion line/channel 160/162. With reference to Figs. 20 and 26, the intravenous fluid 14 flows from the intravenous infusion line 10 through the infusion channel 197, where it is provided for its free flow into the infusion opening 196 and outflow through two passages: through the infusion line 160, as well as through the transfer channel 183, through the blood collection opening 195 into the blood collection channel 194 and from the blood collection line 150. Before connecting the tube holder 120 to the transfer valve and the infusion body 140, the transfer channel 183 on the valve assembly 180 is in the infusion/non-collection position 183a, and the blood collection passage 154 is blocked from the exit of fluid 14 from the passage.

[0160] More specifically, with reference to Figs. 30A and 30B, the blood collection passage 154 may be sealed by the design of the elastomeric central portion 155 having slits 157 and a bulge directed downwardly toward the source of the internal pressure of the fluid 14, wherein the internal pressure of the fluid 14 in combination with the geometry of the central portion 155 provides a tighter seal of the passage 154, preventing the formation of an opening 156 (Figs. 30B and 31B) between the slits 157. As an option or addition, the lower surface of the drive means 184, on which the upper surface 158 of the central portion 155 rests when the device 110 is in the infusion/non-collection mode, may act to seal or further seal the passage 154, preventing the formation of an opening 156 (Figs. 30B and 31B) between the slits 157.

[0161] The following illustrative example of using the illustrative device 110 describes the use of the device 110 for infusing and collecting blood for removing blood 18 from the body of a patient into a collection tube 15 without interrupting the intravenous therapy of the patient. The device 110 is installed between the line 10 for intravenous infusion therapy and the catheter 20 of the patient and is flushed of all air, as described above. The tube holder 120, disconnected from the transfer valve and the collection body 140, is held in one hand, and the thermally insulated projection (not shown) covering the mating portion 130 of the blood outlet passage is removed from the tube holder 120, exposing the portion 130 including the alcohol swab 134 and the pre-sterilized outlet nozzle 132.

[0162] Next, the retaining wings 122 of the tube holder 120 are aligned with the key holes 141a of the transfer valve and the housing 140 for collecting. This also ensures the alignment of the mating part 130 of the outlet passage with the receiving element 188 of the mating part, as well as the alignment of the receiving element 186 of the locking sleeve with the key 126 for ensuring fixation. The tube holder 120 is pressed to the stop in a position so that the valve drive means 184 is placed in the receiving element 124 of the drive means, which ensures the pressing of the key 126 for ensuring the locking into the receiving element 186 of the locking sleeve, with ensuring the deflection of the locking sleeve 148 (including the console 147) downwards, so that it is flush with the upper surface of the upper part 144 of the housing, and, thus, in the axial direction from the receiving element 186 of the locking sleeve, so that the possibility of rotation of the valve drive means 184 (including the rotary valve 182 and the elastomeric valve layer 190) is ensured. In this position, the mating part 130 of the outlet passage is also located inside the receiving element 188 of the mating part of the drive means 184 of the valve, so that it is provided with the possibility of rotating the drive means 184 and the rotary valve 182 as the test tube holder 120 rotates clockwise relative to the housing 140.

[0163] When the locking sleeve 148 is disconnected from the receiving member 186 of the locking sleeve, the tube holder 120 is allowed to rotate clockwise relative to the transfer valve and the collection body 140, ensuring that the holding wings 122 rotate under the holding flanges 141b until the wings 122 reach the rotation stop (not shown), holding the tube holder 120 in place on the transfer valve and the collection body 140.

[0164] During the clockwise rotation of the tube holder 120 relative to the transfer valve and the collection housing 140, several important events occur: (1) the needle-free outlet passage 154 formed on the side of the upper portion 144 of the housing passes under a portion of the platform 131 of the mating portion 130 of the outlet passage and through the alcohol swab 134, thereby wiping and cleaning the needle-free outlet passage 154; (2) the needle-free nozzle 154 moves into a position with axial alignment with the needle-free outlet passage 132, engaging to open and seal the outlet passage 132, allowing the collected blood 18 to flow therebetween; (3) the transfer channel 183 on the rotary valve 182 of the valve assembly 180 is rotated from the rotary position 183a for the infusion/non-collection mode, as shown in Fig. 26-27 (providing a connection between the blood collection channel 152 and the intravenous infusion channel 162), to the rotary position 183b for the infusion/collection mode, as shown in Fig. 28-29, isolating the blood collection channel 152 from the intravenous infusion channel 162.

[0165] This can be clearly seen by comparing Figs. 20 and 21 or Figs. 26 and 28, which show the flow pattern of intravenous fluid 14 through the transfer valve and the collection housing 140, with the transfer channel 183 connecting the channels 152 and 162 in the pivoted non-collecting position 183a, with Figs. 21 and 29, which show the flow pattern of intravenous fluid 14 and blood 18 through the transfer valve and the collection housing 140, with the transfer channel 183 moved to the collection position 183b, which provides isolation of the channels 152 and 162. As shown in Fig. 21, 24 and 28-29, when the transfer channel 183 is in the blood collection position 183b, the introduction of the intravenous therapy fluid 14 through the infusion channel 162 and from the micro-lumen 210 continues without obstruction, as shown in Fig. 25.

[0166] More specifically, with reference to Fig. 30A and 30B, the blood collection passage 154 can be sealed by the design of the elastomeric central portion 155 having slits 157 and a bulge directed downwardly toward the source of the internal pressure of the fluid 14, wherein the internal pressure of the fluid 14 in combination with the geometry of the central portion 155 provides a tighter seal of the passage 154, preventing the formation of an opening 156 (Fig. 30B and 31B) between the slits 157. As an option or in addition, the lower surface of the valve actuator 184, on which the upper surface 158 of the central portion 155 rests when the device 110 is in the infusion/non-collection mode, can act to seal or further seal the passage 154, preventing the formation of an opening 156 (Fig. 30B and 31B) between the slits 157.

[0167] The next step in this illustrative example of use includes placing the collection tube 15 in the tube receptacle 128 of the tube holder 120 and pressing downwards to the position shown in Fig. 22, causing the penetrating needle 136 to pierce the cap 32 of the collection tube, and drawing blood 18 by vacuum in the tube 30 through the blood collection channel 152, namely, through the needle 136 for piercing the collection tube, the needle-free nozzle 132, the needle-free outlet passage 154 sealed by the nozzle 132, the passage 194, the transfer opening 195, the lumen 150 of the outlet passage, the passage 250 defined by the body 202 of the catheter head, and between the catheter 20 and the micro-lumen 210, as shown in Fig. 24-25 and 28-29.

[0168] Referring to Fig. 30B and 31B, in the infusion/collection mode, the blood collection passage 154 is actuated by a beveled projection 133a formed at the distal end of the needle-free outlet nozzle 132 and sized and shaped to align with the opening of the blood collection passage 154. In particular, the upper surface 158 of the elastomeric central portion 155 is pressed axially downward by the projection 133a, deforming the central portion 155 and causing an opening 156 to form between the slits 157, thereby causing blood 18 to flow upward through the axial channel 133b in the nozzle 132 and then through the penetrating needle 136 and into the collection tube 130.

[0169] After the required volume of blood 18 has been collected in the collection tube 15, it is removed from the tube receiving member 128, the tube holder 120 is taken in one hand, and the transfer valve and the collection housing 140 are taken in the other, and the tube holder 120 is rotated counterclockwise relative to the housing 140 and separated from it. Such rotation and such separation ensure that the valve drive means 182 and the rotary valve 184 rotate to the counterclockwise position shown in Fig. 20 and 26-27, allowing the re-attachment of the locking sleeve 148 in the receiving member 186 of the locking sleeve, thereby re-locking the device 110 in the infusion/non-collection mode, in which the needle-free outlet nozzle 132 is also rotated out of alignment with the needle-free outlet passage 154, allowing the outlet passage 154 to be re-sealed, preventing the formation of the hole 156. In the infusion/non-collection mode, the blood collection channel 152 and the infusion channel 162 are again in fluid communication with the rotational position 183a of the transfer channel 182, and the intravenous therapy fluid 14 again flows into both channels 152 and 162 (Fig. 26), flushing the blood collection channel 152 of previously withdrawn blood 18 and allowing the device 110 to be reused with a new or with a sterilized 120 tube holder and a 15 collection tube.

[0170] With respect to the restriction of the blood flow 18 to reduce the flow rate during blood collection to such an extent that the flow of intravenous fluid does not change direction in the vein and is not discharged into the blood collection catheter, as in the case of the device 100, for the device 110 this restriction can be accomplished in various ways known in the art and at various locations along the blood collection channel 152 using an active restriction means, a passive restriction means, or a combination of active and passive restriction means. In the above-described illustrative embodiment of the device 110, the flow rate limitation was achieved passively by selecting the gauge of the needle 136 penetrating the end of the collection tube, wherein the needle is selected with a sufficiently small internal diameter to provide the desired restriction of the blood flow rate. In the illustrative device 110, where the microlumen 210 extends 10 mm beyond the entrance to the catheter 20, limiting the flow rate to about 30 ml/min ensures the desired absence of contamination of the blood sample being collected. This required restriction was provided passively by using a penetrating needle 136 having a gauge of about 24. In another embodiment, it is proposed that the required flow restriction during blood collection can be provided by a Tesla-type valve located anywhere along the blood collection channel 152, including the housing 142.

[0171] In another embodiment, it is proposed that the desired flow restriction during blood collection may be provided by a check valve with a set reverse flow rate instead of a known shut-off means located anywhere along the blood collection channel 152.

[0172] In another embodiment, it is proposed that the desired flow restriction during blood collection may be achieved by a length of reduced diameter channel to create the desired restriction, located anywhere along the blood collection channel 152.

[0173] In another embodiment, it is proposed that the required flow restriction for collecting blood can be achieved by reducing the gap between the outer portion of the micro-lumen 210 and the inner portion of the catheter 20.

[0174] In another embodiment, it is proposed that the required flow restriction for blood collection can be achieved by using a multi-lumen catheter (venous or arterial) instead of the known peripheral intravenous catheter 20 and micro-lumen 210, but with an offset outlet channel and a small enough diameter and length to restrict the flow and prevent dilute blood removal.

[0175] In another embodiment, it is proposed that the required flow restriction for collecting blood can be provided by an active means that is configured to restrict the flow of blood 18 to the collection means and is located at any location along the blood collection channel 152. Illustratively, the active means can include a pump that is configured to remove blood and supply it to the tube 15.

[0176] In another embodiment, it is proposed that the desired flow restriction for blood collection may be provided by a diaphragm, needle, or other similar valve, electronically or manually actuated, to create a restriction at any location along the blood collection channel 152.

[0177] Another embodiment of the invention relates to a novel feature of using a valve to separate two or more infusion channels into a blood collection channel 152 and a channel 162 for intravenous infusion therapy, as shown above. An illustrative embodiment of this feature is the use of a rotary valve, as shown above.

[0178] In another embodiment, it is proposed to use an alternative type of valve. Illustratively, the valve can be a shut-off type valve, a diaphragm type valve, an electrically driven electromagnetic type valve, or a magnetically driven valve.

[0179] In another embodiment, a rotary blood evacuation valve with blocking elements as illustrated herein is described to prevent access to the blood collection passage for patients, such as pediatric patients or agitated patients, or patients suffering from various forms of dementia or having other increased risks associated with additional needle insertions.

[0180] In another embodiment, a sliding blood bleed valve with blocking elements is described to prevent access to the blood collection passage for patients, such as pediatric patients or agitated patients, or patients suffering from various forms of dementia or having other increased risks associated with additional needle insertions.

[0181] Another embodiment describes a collection tube holder with an integral alcohol swab and a means for cleaning the blood collection access passage by sliding or rotating the tube holder in place before and after blood is removed, as described above.

[0182] It should be understood that although the exemplary embodiments of devices 100 and 110 are directed to use with an angiocatheter (i.e., an intravenous catheter) as proposed herein, various features or combinations of features disclosed herein may be applied to other catheters, such as peripherally inserted cardiac catheters, central catheters, and the like. With respect to use with a cardiac catheter, it is understood that the required rate of removal will differ due to the geometry of the vein and the rate of blood flow in the region; however, the same device 110 and system can be used to control the rate of blood collection, and an appropriate length of extension of the micro-lumen tip beyond the catheter tip can be easily determined and applied. In addition, it is understood that the features of one of devices 100 and 110 may be applied to the other device.

[0183] Figures 32-52 illustrate another exemplary embodiment of a blood infusion and collection device, system, and/or methods 300 according to the present invention. The system 300 generally comprises a holding component, a valve component, and an infusion component. The holding component is configured to connect to a collection tube holder 330 to accommodate a standard evacuated collection tube 315. The valve component comprises a valve body 340 (comprising an upper portion 340a and a lower portion 340b) that accommodates a movable element (e.g., a rotary valve 380). The valve component also comprises an inlet 343 for intravenous infusion, an outlet 364 for intravenous fluid, and an outlet 381. The infusion component is connected to a catheter 320, such as a short peripheral intravenous catheter (SPIC).

[0184] Materials from which the tube holder 330, the valve body 340 and the rotary valve 380 can be made include, for example, medical grade plastics and engineering polymers such as acrylonitrile butadiene styrene, polyurethane, polycarbonate, polyethylene terephthalate, polyetherimide, polyetheretherketone, polypropylene, polyethylene terephthalate and the like. For example, the tube holder 330 and the valve body 340 can be made of polycarbonate, and the rotary valve 380 can be made of polypropylene.

[0185] At one end of the valve body 340, the intravenous inlet 343 comprises a separate or integral male connector (not shown) for fluid communication with the female connector 311. At the other end of the valve body 340, the head 363 is connected to the valve body 340 via a luer lock 365 to provide fluid communication of the intravenous infusion channel 358 and the intravenous infusion/blood collection channel 354 with the catheter 320. The luer lock 365 is configured to connect to the outer surface (outer edge) of the body 340 adjacent to the outlet 364.

[0186] The catheter head 363 may have a micro-lumen 360 for intravenous infusion inserted into or through it, wherein the micro-lumen 360 is in fluid communication with an infusate tube 357 located in an intravenous infusion channel 358 in the valve body 340. In some embodiments, the infusate tube 357 is not required, since sufficient connection and sealing of the components for a sealed formation of the channel 358 is provided without it. By connecting to the valve body 340, the catheter head simultaneously connects to a blood tube 353 located in at least a portion of the intravenous infusion/blood collection channel 354, wherein the outlet 364 of the channel 354 is in fluid communication with the catheter 320, as shown in Fig. 48. In some embodiments, the blood tube 353 is not required, since sufficient connection and sealing of the components for the sealed formation of the channel 354 is achieved without it. In some embodiments, the microlumen 360 may comprise a coated tip 361, for example, coated with a fluoropolymer to reduce friction when inserting the microlumen 360 into the catheter 320.

[0187] The rotary valve 380 comprises a valve member 382 which defines a valve passage 389 having openings on the sides of the valve member 382 (see Fig. 45-49). The valve member 382 also defines an outlet passage 381 (see Fig. 33) which is flow-sealed by a partition 376 held in this passage, and receiving elements 606a/b into which the interaction elements 336a and 336b of the tube holder 330 are inserted, which will be described below.

[0188] The tube holder 330 comprises an outlet needle 334 and an elastomeric needle cap 335, wherein the outlet needle 334 is positioned so that it pierces the cap 335 and the septum 376 of the blood infusion and collection device 300, as well as the vacuum collection tube 315 placed in the holder 330 during use. When the tube holder is not in use, it may comprise an attachable cap 370 to prevent injury to the user caused by the opening of the outlet needle 334. The needle cap 335 shown in Fig. 33 is not shown in the remaining figures for clarity.

[0189] Referring to Figs. 33 and 48, intravenous infusion/blood collection channel 354 (which may be defined by portions of blood tube 353, portions of catheter 320, or portions of both) and intravenous infusion channel 358 (which may be defined by portions of infusate tube 357, portions of microlumen 360, or portions of both) extend between intravenous inlet 343 and outlet 362 of valve body 340. After connecting the catheter head 363 to the outlet 364 using the luer lock 365, the micro-lumen 360 is inserted coaxially into the catheter 320. For reasons described in more detail below, the relative lengths of the catheter 320 and the micro-lumen 360 are such that the distal end 362 of the micro-lumen 360 projects from the distal end 322 of the catheter 320 and extends further beyond it, thus extending axially further along and into the patient's vein.

[0190] The micro-lumen 360 is in fluid communication with the infusion channel 358. The radial space between the outer surface of the micro-lumen 360 and the inner surface of the catheter 320 is in fluid communication with the blood collection channel 354 through the outlet 364 (see Figs. 33 and 48). A microlumen 360 having at least a minimum stiffness while remaining flexible enough to be securely retained in the catheter 320 and the vein provides an advantage when inserting the microlumen 360 into the catheter 320. For example, a reinforced microlumen made of uncoated (or coated) polyimide and a braided (or non-braided) layer, such as stainless steel, such as product code 165-111 from Microlumen of Oldsmar, Florida, having an internal diameter of 419 μm (0.0165 inches), has been found to have acceptable properties.

[0191] With reference to Fig. 34, the tube holder 330 comprises a central tube receiving element 332, a tube stopper 333 at the base of the receiving element 332, tube holder interaction elements 336a and 336b, and a withdrawal needle 334. As shown in Figs. 33, 35, and 37, the tube holder interaction elements 336a and 336b, such as projections extending downwardly from the tube holder 330 and having inclined surfaces and locking interaction elements formed thereon, are configured to be installed inside the receiving elements 346a and 346b in the valve body 340 and to interact with the platforms 348a and 348b formed in the valve body 340 when the holder 330 is connected to the valve body 340. During the connection of the tube holder 330 to the valve body 340, the outlet needle 334 extends axially into the upper part 375 of the partition and into the sample chamber 377, ensuring the placement of the needle channel 384 in the internal passage 389 of the valve (see Figs. 34-37 and 47-49). In the illustrated embodiment, the entire tip of the needle 334 extends into the sample chamber 377, and all inclined surfaces of the tip of the needle 334 are in the sample chamber 377, as shown in Figs. 36 and 37.

[0192] The mating portions 336a and 336b of the tube holder in combination with the outlet needle 334 provide a connection of the blood collection tube 315 to the valve housing 340. The tube holder 330 also operates to rotate the rotary valve 380 between the non-collecting position 383a (see Fig. 48) and the collecting position 383b (see Fig. 49), which in the illustrated embodiment is a rotation of about 15 degrees relative to the valve housing 340. As the interaction members 336a and 336b slide through the receiving members 346a and 346b and when the tube holder 330 is axially connected to the valve housing 340, the needle 334 passes through the partition 376 located in the outlet passage 381 of the rotary valve 380.

[0193] The rotation of the rotary valve 380 is provided by continuously moving the interaction elements 336a and 336b downwardly through the receiving elements 346a and 346b contacting the platforms 348a and 348b, when the tube holder 340 is manually pushed out in the axial direction downwardly and directed into rotation relative to the valve body 340. The continued movement in the axial direction downwardly ensures contact of the opposite surfaces of the platform 348a and the interaction element 336a, as well as the platform 348b and the interaction element 336b, respectively, ensuring the direction of rotation of the interaction elements 336a and 336b and the rotation of the rotary valve element 382 through the receiving elements 346a and 346b formed in them relative to the valve body 340. The corresponding locking surfaces of the interaction elements 336a and 336b, corresponding to the locking surfaces of the valve body 340, limit the downward movement in the direction of the tube holder 330 and retention in position relative to the valve body 340, thus also maintaining the position of the rotary valve 380 relative to the valve body 340.

[0194] With respect to the tube holder 330, the withdrawal needle 334 passes through the tube stopper 333 and has an upper end 334a that passes over the stopper 333 and up into the tube receiving element 332 or directly through the needle cap 335 into the blood collection tube 315, if it is connected. The withdrawal needle 334 also passes downwardly under the tube stopper 333 and has a lower end 334b that passes under the tube stopper 333 and down into the central region 339 (Fig. 35) between the mating portions 336a and 336b of the withdrawal passage. Additionally, mechanical elements may be provided in the tube holder 330, the housing 340, and/or the rotary valve 380 such that mechanical projections engage with corresponding locking elements or other sensory feedback to establish a range of limits for full rotation and/or axial movement to ensure proper use and operation.

[0195] Figs. 34-37 illustrate the steps of collecting blood samples: preparing the system 300 for blood withdrawal (Figs. 34-35) and withdrawing the blood into the collection tube(s) 315 in the infusion/collection mode 383b when operating the system 300 in the infusion/collection configuration (Figs. 36-37).

[0196] Referring to Fig. 34-35, prior to connecting the tube holder 330 to the valve body 340, the rotary valve 380 is in the non-collecting position 383a (see Fig. 48). In this position, the passage 389 of the rotary valve 380 provides a fluid connection between the intravenous inlet 343 of the valve body 340 and the blood collection channel 354 of the valve body 340, providing for the delivery of intravenous fluid 314 to the catheter head 363 and the catheter 320 via the device.

[0197] With reference to FIG. 36, 37 and 45-49, when the rotary valve 380 is rotated to the collecting position 383b (see Fig. 49), for example, by introducing the interaction elements 336a and 336b and the outlet needle 334 into the valve body 340 and the partition 376, respectively, the passage 389 the rotary valve 380 moves away from the alignment position with the intravenous inlet 343 and becomes flow-isolated (flow-isolated from within the device 300) from the infusion channel portion 358, while maintaining flow communication (flow communication within the device 300) with the blood collection channel 354, thereby thereby providing a path for blood 318 entering the distal end 322 of catheter 320 to pass through blood tube 353 and enter valve passage 389, septum sample chamber 377 376 and the needle passage 384. In this position 383b, the collection chamber 377 for the sample of the septum 376 (which is located inside the outlet passage 381) is in fluid communication with the collection tube 315 via the needle passage 384.

[0198] When two locations are described as "flow-isolated," "flow-connected," "in flow communication," or the like, as in the above paragraph, it is understood that a fluid path external to the device 300 may exist between the two locations. For example, during rotation of the rotary valve 380 to the collection position 383b, as shown in Fig. 49, flow isolation is provided between the intravenous inlet 343 and the valve passage 389, wherein this flow isolation is provided within the device 300, and there is an allowable fluid path from the inlet 343 to the valve passage 389 through the infusion channel 358, the blood vessel, and the blood collection channel 354. When such a fluid path external to the device/system is provided, the meaning of such expressions as “flow-isolated,” “flow-connected,” and “in flow communication with” in this context implies that the isolation, connection, or communication relates to internal passages and functions of the device/system 300 or 100.

[0199] Once the blood has been collected, the collection tube 315 can be detached from the tube holder 330, and subsequent collection tubes 315 can be attached, filled, and detached as needed. In the absence of the collection tube 315, a lack of vacuum, a passive restriction of the fluid flow by the needle 334, and an additional seal by the elastomeric cap 335 covering the upper end 334a of the needle 334, the blood 3 will not pass through the needle 334. The appropriate flow restriction can be achieved by selecting the required internal diameter of the needle 334, by crimping the needle 334 to a certain required cross-sectional area, or by other mechanically passive means for restricting the flow.

[0200] To return the system 300 to the infusion/non-collection configuration and to the infusion/non-collection mode 383a (see Figs. 34-35), the tube holder 330 is rotated counterclockwise and separated axially from the valve housing 340. Rotating the holder 330 counterclockwise returns the rotary valve 380 to the non-collection position 383a, resuming flow communication of the blood collection channel 354 with the therapy fluid 314 from the intravenous inlet 343. Rotating the holder 330 counterclockwise also allows the mating portions 336a and 336b and the needle 334 to move upward axially. Preferably, the septum 376 is self-sealing and reusable such that upon repeated withdrawal of the needle 334, the intravenous fluid 314 passes through the valve passage 389 without leaking through the septum 376.

[0201] Preferably, the collection of blood 318 occurs simultaneously with and without interruption of the infusion of intravenous therapy fluid 314 through the infusion channel 358, with an outlet into the patient's vein at the distal end 362 of the microlumen 360. The ability of the system 300 to provide this function is due in part to two features of the device: the protrusion of the tip of the microlumen 360 in the vein to an optimally minimal distance beyond the tip of the catheter 320 (see Fig. 32); and a corresponding restriction of the flow of collected blood 318 when the rotary valve 380 is rotated to the collection position 383b.

[0202] When determining the precise dimensions of the components of the device, system and/or methods 300 for infusion and collection of blood (or device/system/method 100), a number of parameters can be taken into account to ensure effective operation of the device/system in various situations. These parameters include the type of patient (e.g., humans (including adults, adolescents, children and infants), dogs, cats, etc.), the location of the vein (arm, leg, etc.), the diameter of the normal vein being accessed, standard venous superficial velocities in the vein being accessed, the density and viscosity of the expected intravenous fluid, the standard density and viscosity of the blood, the thickness of the wall of the microlumen and the standard vacuum pressure in the blood collection device.

[0203] In one exemplary embodiment, the distal tip 362 of the micro-lumen 360 extends at least 9 mm (0.35 inches) beyond the distal tip 322 of the catheter 320, the inner diameter of the needle 334 is 0.30 mm (0.012 inches), and the length of the needle 334 is 3.3 cm (1.3 inches), which provides a maximum flow rate for collecting blood of 5 ml/min and prevents mixing of the intravenous fluid 314 flowing from the distal tip 362 of the micro-lumen 360 with the blood 318 entering the distal tip 322 of the catheter 320 for collection into the collection tube 315. The device/system/method with these features is effective when used in a standard adult forearm vein with a standard superficial venous blood velocity in the forearm, with a typical forearm vein diameter, an intravenous fluid flow rate greater than 1 ml/min, a minimum micro-lumen wall thickness, standard blood density and viscosity, typical intravenous fluid density and viscosity, and standard vacuum pressure (mmHg) in modern vacuum devices, such as Vacutainers® and Vacuettes®.

[0204] In another embodiment, the distal tip 362 of the micro-lumen 360 extends at least 3 mm (0.12 in) beyond the distal tip 322 of the catheter 320, and the inner diameter and length of the needle 334 are selected to provide a maximum blood collection flow rate of less than 5 ml/min to prevent mixing of the intravenous fluids 314 with the blood 318 collected through the catheter 320.

[0205] Additional embodiments include selecting the length of the micro-lumen and the size of the needle to remove blood without contamination of intravenous fluid from patients and veins of various sizes, such as veins in the arms or legs of adults, pediatric patients, or neonatal patients. As an example, a manufacturer may market a device/system in three sizes, one for adult patients, one for pediatric patients, and one for neonatal patients.

[0206] The general design of embodiments such as those shown in Figs. 1 and 32 allows for the device/system/method to be easily adapted to operate effectively in a variety of situations. As an example, by adjusting three parameters - the distance that the distal tip 362 of the micro-lumen 360 extends beyond the distal tip 322 of the catheter 320, the diameter of the lumen through the needle 334, and the length of the lumen through the needle 334 (which may be approximately equal to the length of the needle 334) - the device/system/method can be modified for use with different patients and in different situations, providing for the simultaneous infusion of intravenous fluid while drawing blood that is not mixed with the intravenous fluid.

[0207] Depending on the size of the catheter 320 used, the microlumen 360 may occupy from 5% to 95% of the internal diameter of the catheter 320. In other embodiments, the microlumen 360 occupies from 10% to 50%) of the internal diameter of the catheter 320, and in another embodiment, the microlumen 360 occupies from 15% to 30% of the internal diameter of the catheter 320.

[0208] The size of the micro-lumen 360 should be large enough that when the device transitions from a mode of infusing intravenous fluid through the micro-lumen 360 and the catheter 320 to a mode of infusing intravenous fluid only through the micro-lumen 360 (the catheter 320 is used to remove blood), the passage through the micro-lumen 360 does not create a back pressure in the intravenous fluid that exceeds the set value of the intravenous pump for detecting obstruction (e.g., greater than 68.9 kPa (10 psi)). If the pressure in the micro-lumen 360 is too high when intravenous fluid is being delivered only through the micro-lumen 360, the intravenous fluid pump will reach the set obstruction pressure (essentially detecting the presence of an obstruction) and will automatically turn off (essentially "assuming" the presence of an obstruction), thereby stopping the infusion of intravenous fluid into the patient's body and preventing blood from being flushed out of the catheter 320 when the healthcare professional stops collecting blood from the patient.

[0209] The catheter 320 in the exemplary embodiment 300 is an 18 gauge catheter, although other embodiments may include larger gauge catheters (e.g., 16, 14, and 12 gauge catheters) without significantly changing (by more than 20 percent (20%)) the dimensions of other portions of the device 300. Smaller gauge catheters (e.g., 24 and 26 gauge catheters) may also be used with the device 300 for compatibility with small patients (e.g., premature infants), although other portions of the device 300 will likely require sizing.

[0210] With respect to restricting the blood flow 318 to reduce the flow rate during blood collection to such an extent that the flow of intravenous fluid does not change direction in the vein and is not discharged into the catheter 320 and the blood collection tube 315, this restriction can be implemented at various locations along the path of blood flow 318 between the distal end 322 of the catheter 320 and the tube 315, either by an active restriction means (e.g., by means of a configurable valve, a worm gear, or a pump), or by a passive restriction means, or by a combination of active and passive restriction means.

[0211] In the above illustrative embodiment of the system 300, passive flow rate limitation is accomplished by selecting the gauge of the withdrawal needle 334 that enters the end of the collection tube 315. A needle with a sufficiently narrow inner diameter is selected to provide the desired flow rate limitation of the blood. If a larger inner diameter is used, this would require decreasing the vacuum in the tube 315 (otherwise expressed as less negative pressure, a weaker vacuum, or a higher absolute pressure), increasing the length of the needle (slowing down the fluid due to the surface area inside the needle), or using a combination of both. The advantages are that the entire length of the needle is used to slow the flow of blood being collected to the desired rate. While in some embodiments the flow rate may be limited by plugging or crimping, which provides a small opening a short distance in the direction of flow, caution must be exercised since this type of flow limitation increases the likelihood of negative consequences, such as damage to the blood sample (e.g., hemolysis due to blood shear or other physical forces).

[0212] In an exemplary device/system/method 300, in which the distal end 362 of the micro-lumen 360 extends, for example, about 10 mm beyond the distal end 322 of the catheter 320, limiting the flow rate to about 5 ml/min or less provides the desired prevention of contamination of the collected blood sample. This desired limitation is achieved by using an exit needle 334 having a gauge of about 24.

[0213] The volumetric flow rate (Q) of the blood 318 is achieved by changing the pressure (ΔP) of the blood 318 between the patient and the collection tube 315, and in particular, in the illustrative embodiment of the system 300, at the point of highest passive restriction of the blood flow 318, in the withdrawal needle 334. The principles of fluid flow with an applied force and a no-slip boundary condition between the desired volumetric flow rate (Q) and the pressure gradient (ΔP) are used to determine the gauge of the needle that will limit the volumetric flow rate (Q) to a desired value, such as about 30 ml/min or less, or about 15 ml/min or less, or 10 ml/min or less. In an illustrative embodiment, for example, using a 0.029 m (1.16 in) 18 gauge catheter and a 6 ml red collection tube 315, a typical blood flow rate 318 is about 7 ml/min.

[0214] Fig. 38-40 shows an example of an output needle 334 for placement within a tube holder 330 of a system 300 according to one embodiment of the present invention. The exemplary output needle 334 may have a body 400 cut from a round stainless steel hypodermic tube and may have tip ends 385a and 385b. In the illustrated embodiment, the tip 385a is configured to pierce the covering body 335 and the collection tube 315, while the tip 385b is configured to pierce the septum 376 of the system 300. The withdrawal needle 334 can have a total length 402 of about 0.033 m (1.3 inches), including, for example: a first portion 404 of about 0.007 m (0.28 inches) in length, which extends into the central region 339 of the tube holder 330, a second portion 406 of about 0.005 m (0.20 inches) in length, which connects the needle 334 to the tube holder 330 (for example, with glue), and a third portion of about 0.022 m (0.85 inches) in length, the tip of which extends into the central receiving element 332 of the tube. Each end 385a and 385b has a beveled portion and a lanceolate portion. The end 385a is configured to penetrate the seal of the vacuum container 315 and comprises a beveled portion 422 having a primary beveled angle 412 of about 11 degrees relative to the housing 400, and a second beveled portion 424 having a secondary beveled angle 416 of about 19 degrees relative to the longitudinal axis of the housing 400. The end 385b is configured to penetrate the partition 376 and comprises a beveled portion 418 having a primary beveled angle 410 of about 18 degrees relative to the longitudinal (long) axis of the housing 400, and a secondary beveled portion 420 having a secondary beveled angle 414 of about 32 degrees relative to the longitudinal axis of the housing 400. To ensure an optimal flow rate, as noted above, the needle 334 can have an inner diameter 426 of about 0.3 mm (0.012 in) and an outer diameter 428 about 0.9 mm (0.036 in).

[0215] As described herein, the withdrawal needle 334 is configured to puncture the septum 376 when the tube holder 330 is connected to the rotary valve 380 in the collection mode 383b, and the septum 376 provides a self-sealing of the puncture when the holder 330 and the rotary valve 380 are separated. To provide self-sealing, the septum 376 can be made of an elastomeric material. The septum 376 has a generally truncated cone shape, including a cylindrical body 500, a flat inlet surface 375 for entering the withdrawal needle 334, a flat outlet surface 502 for exiting the withdrawal needle 334 from the septum 376 and entering the sample chamber 377 (see Figs. 36-37) and a flat surface 504 that faces the intravenous infusion/blood collection channel 354 when the septum 376 is mounted on the rotary valve 380. The puncture surface 375 is flat, which allows for easier cleaning by simply wiping after collection has been made and the tube holder 330 has been removed.

[0216] The transition surface 506 and the puncture exit surface 502 together form the upper boundaries of the internal sample chamber 377 or vaults. Advantageously, after collection is performed using the exit needle 334 inside the sample chamber 377 and the exit needle 334 is removed from the chamber 377, the septum 376 ensures that any residual fluid (e.g., blood) remaining inside the chamber 377 is washed out into the intravenous infusion/collection channel 354 when the intravenous fluid 314 flows back through the channel 354 when the rotary valve 380 is rotated to the non-collecting position 383a. In other words, the shape of the lower part of the partition 376 can be designed such that the intravenous fluid 314 washes out any residual fluid remaining in the chamber 377 (for example, a medium adhered to the walls of the chamber 377) after collection from the second end of the housing, the end defining the chamber 377, and into the passage 354 for intravenous infusion/collection of blood after the rotary valve 380 provides a transition from the collection position 383b to the non-collection position 383a. To ensure flushing of the chamber 377, in some embodiments, it can extend less than half the entire length of the partition 376. Providing the partition 376 with a chamber 377 for insertion of the needle 334 provides an advantage, since the concave chamber 377 allows the channel 354 for intravenous infusion/collection to be made narrower (i.e., with a smaller cross-sectional diameter), and a smaller cross-sectional area can provide easier flushing. Also, the curved surface of the chamber 377 also provides for the insertion of the needle 334 and irrigation, and the truncated cone shape described herein provides a combination of space for the needle 334 and the possibility of irrigation.

[0217] In alternative embodiments, the partition 376 and the rotary valve 380 are formed together as a single continuous, integral piece. In these embodiments, the sample chamber 377 also represents a raised portion of the passage 389 formed by the rotary valve 380.

[0218] To provide the collection and washing described above, in at least one embodiment, the sample chamber 377 has the following approximate dimensions: a diameter 508 of 5.08 mm at the top surface 375; a height 510 of 4.8 mm; a diameter 512 of 4.76 mm at the bottom surface 504; a diameter 514 of 2.54 mm at the opening of the chamber 377; a diameter 516 of 1.0 mm at the exit surface 504 of the puncture in the chamber 377; a depth 518 of 1.91 mm of the chamber 377; a surface angle 520 of 92 degrees at the surface 500 of the body between the top 375 and bottom 504 surfaces relative to the normal of the top surface 375; and a surface angle 522 of 67.5 degrees at the transition surface 506 of the chamber relative to the normal of the surface 502 of the puncture. For example, in one embodiment, surface angle 522 is less than about 70 degrees, the ratio of diameter 514 to diameter 516 is greater than about 2.5, and the ratio of depth 518 to diameter 514 is less than about 1.0 or less than about 0.75.

[0219] Advantageously, the sample chamber 377 has a shape and dimensions that ensure that the entire edge of the withdrawal needle (for example, the beveled portion 418 of the withdrawal needle 334) is accommodated so that collection can be carried out without hindrance on any surface of the partition 376. The chamber 377 also advantageously has such a shape and dimensions, as well as an inclined (non-perpendicular) transition surface 506 relative to the normal of the puncture surface 502, due to which resistance is provided and, thus, the chamber 377 is prevented from turning over when the withdrawal needle 334 pierces the surface for one or more collections. In alternative embodiments of the chamber 377, it can have the shape of a rounded arch, rather than the shape of a truncated cone. However, the rounded arch can, under some circumstances, be turned over when the withdrawal needle 334 is inserted, thus blocking the gap of the needle 334 and preventing collection.

[0220] Additionally, having a concave lower surface for the withdrawal needle 334 (e.g., surfaces 502, 504, and 506) for collection provides the intravenous infusion/collection channel 354 and, ultimately, the valve body 340 is smaller than in embodiments that do not have a concave lower surface, while the sample chamber is smaller and provides for faster clearing of residual body fluid with the intravenous fluid.

[0221] In some embodiments, sample chamber 377 defines a central axis (e.g., an axis extending perpendicular from outlet surface 502) that is perpendicular to the general direction of fluid flow through valve passage 389, which is generally parallel to the lumen in blood tube 353.

[0222] Figs. 45-49 illustrate a rotary valve 380 according to one embodiment of the present invention. In use, the rotary valve 380 is inserted into the valve housing 340, wherein the outer rim 608 and the top 340a of the valve (see Fig. 33) form a flat surface. An opening 602 in the rotary valve 380 defines an entrance to a valve passage 389, which, when the device is in the intravenous infusion/non-collection mode 383a, connects the intravenous inlet 343 to the intravenous infusion/collection channel 354 defined by the valve housing 340. In particular, with reference to Fig. 48, the intravenous fluid 314 in the intravenous infusion/non-collecting mode 383a passes into the opening 602 of the passage and passes directly through the rotary valve 380 before exiting through the passage 604, into the blood collection channel 354 and to the catheter 320. Once the tube holder 330 and the corresponding vacuum collection tube 315 are inserted into the rotary valve 380, in particular by pressing the inclined members 336a and 336b of the tube holder 330 interaction into the receiving members 606a and 606b of the rotary valve, which causes the holder 330 and the rotary valve 380 to rotate, the valve 380 rotates from the non-collecting position 383a, in which the passage 389 of the valve is in fluid communication with both the intravenous inlet 343 and the blood collection channel 354 (see Fig. 48), to the collection position 383b, in which the passage 389 is fluidly isolated from the intravenous inlet 343, but remains fluidly connected to the blood collection channel 354 (see Fig. 49). As shown in Fig. 45, the seal 603 can surround the opening 602 to prevent leakage of fluids into the space between the valve member 382 and the valve body 340. For example, the seal 603 can be formed on the surface of the member 382, such as with a surface layer of medical grade silicone or another seal, gasket or ring.

[0223] At collection position 383b and with the vacuum collection tube installed in the tube holder 330, blood 318 enters the rotary valve 380 through passage 604 and ultimately into the collection tube 315 (see FIGS. 36-37). Valve passage 389 forms part of the infusion/non-collection passage as well as the blood collection passage at valve positions 383a and 383b, respectively. Advantageously, the passage 604 is extended so that when the rotary valve is rotated by about 15 degrees from the infusion/non-collection position 383a (Fig. 48) to the infusion/collection position 383b (Fig. 49), a flow communication is maintained between the passage 389 of the valve and the infusion/collection channel 354, while the passage 389 is disconnected from the intravenous inlet 343. As shown in Fig. 45, the seal 605 can surround the passage 604 to prevent leakage of fluids into the space between the member 382 and the valve body 340. For example, the seal 603 can be formed on the surface of the member 382, such as with a surface layer of medical grade silicone or another seal, gasket or ring.

[0224] Figs. 48 and 51 show a micro-lumen 360 positioned within an intravenous infusion channel 358. In Figs. 49, 50 and 52, the micro-lumen 360 is not shown for illustrative purposes. In one embodiment, the micro-lumen 360 and the infusate tube 357 are connected to the valve body 340 by initially positioning about 1-3 mm of the tip of the micro-lumen 360 within the infusate tube 357. (Referring to the orientation in Fig. 33, the left end of the micro-lumen 360 is initially positioned within the right end of the tube 357.) An adhesive is applied to the outer surfaces of the connected micro-lumen 360 and the tube 357, and the connected micro-lumen 360 and the tube 357 are inserted into the intravenous infusion channel 358. Once hardened, the adhesive holds the lumen 360 and tube 357 together, holding them within the channel 358 and providing a seal to any open portions between the lumen 360 and tube 357 where fluid might otherwise leak.

[0225] Figs. 50-51 are cross-sectional views of the connection between the valve body 340 (which contains the infusion/blood collection channel 354 and the intravenous infusion channel 358), the luer lock 365, the catheter head 363, and the catheter 320. Fig. 52 is an end view of the valve body 340 that is connected via the catheter head 363 to the catheter 320, but the head 363, the catheter 320, and the micro-lumen 360 are not present in this view. In the end view of Fig. 52 shows an intravenous outlet 364 including a first opening 702 into an intravenous infusion channel 358, which typically contains a micro-lumen 360, and a second opening 704 into an infusion/blood collection channel 354.

[0226] In particular, the valve body 340 comprises an intravenous outlet 364 that forms a receiving element that extends outwardly, wherein its distal end forms a distal surface 706 that is generally a concave surface that may have both curved and non-curved portions. The illustrated embodiment comprises a first portion 708 and a second portion 710 that together form an asymmetric funnel shape, for example, its "neck" is directed toward the center and is formed by a channel 354 for infusion/blood collection, and a channel 358 for intravenous infusion opens through its wall. The first part 708 forms a curved transverse surface, and the infusion/blood collection channel 354 passes through the valve body 340 and ends on the surface of the first part 708. The second part 710 forms a concave, convex or flat transverse surface, and the infusion channel (in which the microlumen 360 is located) passes through the valve body 340 and ends on the surface of the second part 710.

[0227] When operating in the infusion/non-collection mode 383a, intravenous fluid will be delivered to the patient via two pathways: through the intravenous infusion channel 358 to the micro-lumen 360, and through the blood tube 353 to the catheter 320. After switching to the infusion/collection mode 383b and with suction applied to the infusion/collection channel 354, intravenous fluid will continue to be delivered to the patient via the intravenous infusion channel 358 and the micro-lumen 360, and the blood tube 353 and catheter 320 will provide for the transfer of biological fluid (e.g., blood) from the patient. When switching back to the infusion/no collection mode 383a, the intravenous fluid will continue to flow to the patient through the intravenous infusion channel 358 and the microlumen 360, and the intravenous fluid will begin to flow through the infusion/blood collection channel 354, the blood tube 353 and the catheter 320, providing for the movement of biological fluid from the channel 354, the sample chamber 377, the blood tube 353 and the catheter 320 to the patient. As can be understood from this description of the self-flushing of the system 300, there is no need for the healthcare professional caring for the patient to flush the device 300 after the biological fluid has been removed.

[0228] The shape and height of the recessed roof of the sample chamber 377 affects the efficiency of removal of residual fluid (e.g., blood) remaining within the chamber by the flushing fluid (e.g., intravenous fluid). Taller roofs are generally less efficient at removing residual fluid, especially at low flow rates. However, roofs that are too short or too small will not provide sufficient clearance for the withdrawal needle 334 to enter the sample chamber.

[0229] Due to the shape of the chamber 377 for the sample septum 376, the intravenous fluid will move to all corners of the chamber 377 and will wash away all residual biological fluid on its own. Although the exact mechanism is not yet clear, it is believed that the chamber 377 of the septum 376 creates swirls (and/or turbulence) in the fluid flowing through the passage 389 when it reaches the chamber 377, providing for the circulation of the fluid near the surface 506 of the chamber 377 at an increased speed, causing sufficient friction with the surface to quickly wash away all biological fluid into the passage 389 and back to the patient.

[0230] Because the fluid loses the ability to effectively remove fluid from the passageway (e.g., the fluid may lose a significant portion of its turbulent flow) as it moves from the sample chamber 377 and approaches the distal end 705 of the valve body 340, the distal end 705 of the body 340 is carefully shaped to effectively remove (e.g., flush) all biological fluid remaining in the chamber between the end of the infusion/blood collection channel 354 and the beginning of the catheter 320 in the patient. In the embodiment shown in FIG. 48-52, the distal end 705 of the intravenous outlet 364 of the valve body 340 has an asymmetric shape, shown in the drawings as a surface 706. The asymmetric shape of the surface 706 resembles a truncated cone that generally converges at the opening of the infusion/blood collection channel 354 with a first portion 708 (which may be called the upper portion due to its orientation in Fig. 50) and a second portion 710 (which may be called the lower portion due to its orientation in Fig. 50), which are formed separately since their shapes may be different. In some embodiments, the asymmetric shape resembles the surface of an oblique cone. This asymmetric shape helps ensure that the intravenous fluid 314 flowing through the connecting region 703 completely and quickly washes out all residual biological fluid in the connecting region 703 and discharges it through the catheter 320. The exact mechanism of the process is unknown, but it appears that the asymmetric funnel-shaped shape of the concave surface 706 creates vortices (and/or turbulence) in places that cause sufficient movement of fluid near the concave surface 706 to quickly wash out the biological fluid from the surface 706 and back to the patient.

[0231] In the embodiment shown in Figs. 48-50, the apex of the surface 706 (the location where the curved surface of the concave surface 706 would converge if not for the gap formed by the infusion/blood collection channel 354) is recessed behind the opening of the infusion/blood collection channel 354. In other words, the apex may be located within the infusion/blood collection channel 354. In some embodiments, the apex is offset to one side from the central axis 355 of the infusion/blood collection channel 354 (in Fig. 50, the apex is offset "above" the central axis) and toward the outer edge of the valve body 340 adjacent to the outlet 364, in other words, toward the outer edge of that portion of the valve body 340 that is connected to the luer lock 365. In these embodiments, the maximum depth of the concave surface is offset to one side from the central axis 355.

[0232] The central axis 709 of the concave surface 706 originates at the apex in the infusion/blood collection channel 354 and is inclined at an angle 707 relative to the central axis 355 of the channel 354 (or relative to the longitudinal axis of the valve body 340). In some embodiments, the angle 707 is from 10 to 30 degrees, and the angle between the axis 709 and the surface of the concave surface 706 is from 15 to 40 degrees, in other words, the overall cone opening angle is from about 30 to 80 degrees. In other embodiments, the angle 707 is from 15 to 25 degrees, and the angle between the axis 709 and the surface of the concave surface 706 is from 20 to 25 degrees, in other words, the overall cone opening angle is from about 40 to 50 degrees. In other embodiments, angle 707 is approximately 20 degrees, and the angle between axis 709 and the surface of concave surface 706 is approximately 23 degrees, in other words, the overall cone opening angle is approximately 45 degrees.

[0233] Although at least one shape of the concave surface 706 has been described as approaching a cone with an apex, which may mean that the sides of the cone converge at a single point, the shapes in other embodiments generally resemble a cone, but its surfaces do not converge at a single point, but instead converge to form a line that may be straight (one-dimensional) or curved in two or three dimensions. In addition, while the concave surface 706 is generally shown in cross-section as a straight line, which provides an advantage in the manufacture of the device, in other embodiments the concave surface 706 is curved in cross-section. In other embodiments, the concave surface 706 has a conical cross-section, which may provide advantages in manufacture at least in part due to its relatively simple shape.

[0234] The intravenous infusion channel 358 intersects the concave end surface 706 at a location different from the location at which the infusion/blood collection channel 354 intersects the end surface 706. In some embodiments, the location where the intravenous infusion channel 358 intersects the concave end surface 706 and the apex are on opposite sides from the central axis 355 of the channel 354. Because the micro-lumen 360 passes through the intravenous infusion channel 358 and into the catheter 320, fluid entering or exiting the channel 354 is prevented from mixing with fluid in the micro-lumen 360.

[0235] As noted above, embodiments of the inventive system 300 provide for rapid and effective flushing of any remaining blood that may remain in the catheter 320, the infusion/blood collection channel 354, or the connecting region 703 between the catheter 320 and the valve body 340 after the blood has been removed, and directed back to the patient through the catheter 320 after switching the system 300 from the intravenous infusion/blood collection mode 383b back to the intravenous infusion/no collection mode 383a. In an exemplary embodiment, a minimum intravenous infusion rate of 10 ml/hour after switching from the intravenous infusion/collection mode is sufficient and provides for timely flushing of the system 300 to prevent accumulation of residual blood in the device, including areas in the connecting region 703 partially blocked by the microlumen 360.

[0236] Embodiments of the present invention include a device, system, or method for infusing and collecting blood that includes an intravenous infusion line, an intravenous catheter, or both, and an intravenous catheter, while other embodiments include a device or system for infusing and collecting blood independent of the intravenous infusion line and the intravenous catheter.

[0237] References that may be used in this document may generally refer to various directions (e.g., up, down, forward, and back), which are provided only to aid in understanding various embodiments of the invention and should not be construed as limiting. Other references may be used to describe various embodiments, for example, the direction of movement of a projectile when exiting a firearm may be upward, downward, backward, or in any other direction.

[0238] Although examples, one or more typical embodiments, and specific forms of the invention have been illustrated and discussed in detail in the foregoing description and with reference to the drawings, these are to be considered illustrative and not restrictive or limiting. The description of specific features in one embodiment does not mean that these specific features are necessarily limited to this one embodiment. Some or all of the features of one embodiment may be used in combination with some or all of the features of other embodiments, as will be apparent to those skilled in the art, regardless of whether this is expressly stated. One or more exemplary embodiments have been shown and described, and all changes and modifications within the spirit of the present invention are also included within the scope of the invention.

Claims (43)

1. A device for intravenous administration of fluid into a living organism and for collecting blood from it, containing: an intravenous device (300) in which a first channel (354) for liquid is provided, which is designed with the possibility of ensuring the selective movement of intravenous liquid (314) into a living organism and the selective removal of biological liquid (318) from said organism, and an outlet element (364) which has a concave surface (706) at the distal end, wherein said first fluid channel passes through the outlet element and ends at the concave surface of the distal end, wherein the maximum depth of the concave surface of the distal end is offset relative to the center of the outlet element to create a path for the flow of fluid that ensures the removal of residual biological fluid remaining on the concave surface of the distal end after the transition of the intravenous device from the removal of biological fluid from a living organism through said first fluid channel to the introduction of intravenous fluid into said organism through said first fluid channel. 2. The device according to claim 1, further comprising a passage (604) for a biological fluid and an outlet element (334) for a fluid, wherein in the first configuration of the intravenous device, the flow of intravenous fluid is ensured through said first channel for fluid from the passage (343) for the intravenous fluid to the passage for the biological fluid for introducing the intravenous fluid into a living organism, and in the second configuration of the intravenous device, the flow of biological fluid is ensured into said first channel for fluid and through the outlet element for fluid. 3. The device according to claim 1, wherein the center of said first fluid channel is on the same line with the point of maximum depth of the concave surface of the distal end. 4. The device according to claim 1, in which the outlet element has an outer edge, and the center of said first fluid channel is offset in the direction of the outer edge of the outlet element from the point of maximum depth of the concave surface of the distal end. 5. The device according to claim 1, comprising an outlet element (334) for liquid, intended for removing biological liquid from a living organism, wherein said outlet element comprises a channel (384) that passively limits the rate of flow of biological liquid through said outlet element. 6. The device according to claim 1, comprising a second channel (358) for liquid, made parallel to said first channel for liquid, wherein said second channel for liquid is made with the possibility of ensuring the transfer of intravenous liquid to a living organism before, during and after the transition of the intravenous device from the removal of biological liquid from a living organism through said first channel for liquid to the introduction of intravenous liquid into said organism through said first channel for liquid. 7. The device according to claim 6, comprising a medical tube (360) fluidly connected to said second fluid channel, and a catheter (320) connected to the outlet element, wherein the medical tube extends outward from the outlet element and into a passage inside the catheter for transferring intravenous fluid into a living organism. 8. The device according to item 6, which provides for the simultaneous removal of biological fluid from a living organism through said first channel for fluid and the introduction of intravenous fluid into said organism through said second channel for fluid. 9. The device according to claim 6, further comprising a valve body (340) and a valve element (380), wherein said second fluid passage is formed in the valve body, wherein said valve element and the valve body define said first fluid passage. 10. The device according to claim 1, wherein the concave surface of the distal end forms a surface (708, 710) in the form of an asymmetric funnel. 11. The device according to claim 10, wherein said surface in the form of an asymmetric funnel defines a central axis (709), a first part (708) of the surface and a second part (710) of the surface, wherein said first part of the surface is inclined relative to the central axis by a first angle, and said second part of the surface is inclined relative to the central axis by a second angle, wherein said first and second angles are different. 12. The device of claim 1, wherein said first fluid channel defines a central axis, and the concave surface of the distal end defines the central axis, wherein the central axis of the concave surface of the distal end is inclined from the central axis of said first fluid channel. 13. The device according to claim 1, wherein said first fluid channel defines a central axis, and the concave surface of the distal end defines a conical surface (708, 710) and a central axis (709), wherein the central axis of the concave surface is inclined from the central axis of said first fluid channel in the direction of the central axis of the second fluid channel. 14. The device according to claim 1, further comprising a sealing element (376), at the first end (504) of which a concave surface (506, 502) is formed, wherein said concave surface forms the surface of said first channel for liquid, wherein the sealing element is configured to: placing an outlet element (334) for liquid passing through the sealing element into said first channel for liquid through the concave surface, forming a seal around the liquid outlet element passing through the sealing element into said first liquid channel through the concave surface, and preventing the release of residual biological fluid and intravenous fluid from said first fluid channel through the sealing element after removal of the fluid outlet element from the sealing element. 15. The device according to item 14, wherein the sealing element is made of an elastomeric material. 16. The device according to claim 14, wherein the fluid outlet element comprises a channel (384) that passively limits the rate of flow of biological fluid through the fluid outlet element. 17. The device according to claim 1, further comprising a valve body, wherein said valve body forms said outlet element, wherein the outlet element is configured to be connected to a catheter. 18. A device for intravenous administration of fluid into a living organism and for collecting blood from it, comprising: an intravenous device (300) in which a first channel (354) for liquid is provided, configured to ensure selective movement of intravenous liquid into a living organism and removal of biological liquid from said organism, an outlet member (364) that has a concave surface (705) at the distal end, wherein said first fluid passage passes through the outlet member and terminates at the concave surface of the distal end, wherein the concave surface of the distal end has a shape that provides for the creation of a fluid flow path that provides for the removal of residual biological fluid remaining on the concave surface of the distal end, after the transition of the intravenous device from the removal of biological fluid from a living organism through said first fluid passage to the introduction of intravenous fluid into said organism through said first fluid passage, and a sealing element (376), at the first end (504) of which a concave surface (506, 502) is formed and which is connected to the intravenous device, wherein the concave surface forms the surface of the said first channel for liquid, wherein the sealing element is configured to: placing an outlet element (334) for liquid passing through the sealing element and into said first channel for liquid through the concave surface, forming a seal around the liquid outlet element passing through the sealing element and into said first liquid channel through the concave surface, and preventing the release of residual biological fluid and intravenous fluid from said first fluid channel through the sealing element after removal of the fluid outlet element from the sealing element. 19. The device according to claim 18, further comprising a second channel (358) for liquid, made parallel to said first channel for liquid, wherein said second channel for liquid is made with the possibility of ensuring the transfer of intravenous liquid into a living organism before and after the transition of the intravenous device from the removal of biological liquid from a living organism through said first channel for liquid to the introduction of intravenous liquid into said organism through said first channel for liquid. 20. An intravenous device (300) for introducing fluid into a living organism and collecting blood from it, comprising: valve body (340), a valve element (380), wherein said valve element and the valve body define a first channel (354) for fluid, which is designed to ensure the selective movement of intravenous fluid (314) into a living organism and the removal of biological fluid (318) from said organism, and an outlet element (364) connected to the valve body, configured to be connected to the catheter (320) and forming a concave surface (705) at the distal end, wherein said first fluid channel passes through the outlet element and ends at the concave surface of the distal end, wherein said concave surface has a shape that provides for the formation of a fluid flow path that provides for the removal of residual biological fluid remaining on said concave surface after the intravenous device has transitioned from removing biological fluid from a living organism through said first fluid channel to introducing intravenous fluid into said organism through said first fluid channel, and a sealing element (376), at the first end (504) of which a concave surface (506, 502) is formed, wherein the concave surface forms the surface of the said first channel for liquid, wherein the sealing element is designed with the possibility of: placing a liquid outlet element passing through the sealing element and into said first liquid channel through the concave surface, forming a seal around the liquid outlet element passing through the sealing element and into said first liquid channel through the concave surface, and preventing the release of residual biological fluid and intravenous fluid from said first fluid channel through the sealing element after removal of the fluid outlet element from the sealing element, and a second channel (358) for liquid, formed in the valve body parallel to the said first channel for liquid, a medical tube (360) fluidly connected to said second fluid channel, and a catheter (320) connected to the outlet member, wherein the medical tube extends outward from the outlet member and into a passage (703) inside the catheter for transferring intravenous fluid into a living organism, wherein said second fluid channel is configured to ensure the transfer of intravenous fluid into said organism before, during and after the transition of the intravenous device from the removal of biological fluid from said organism through said first fluid channel to the introduction of intravenous fluid into said organism through said first fluid channel.