Blood saving blood collection device

Abstract

A blood collection assembly coupleable to a vascular access device, the blood collection device having a first branch, a second branch, a third branch, and a channel configured for fluid communication therebetween, and a syringe having a syringe body, a plunger, and a stopper, the plunger and the stopper being compressible and retractable within the syringe body, the syringe being coupled to the first branch of the blood collection device. The assembly may also include a test sample collection device coupled to the second branch of the blood collection device, and an access portion coupled to the third branch of the blood collection device, configured to provide fluid communication between the vascular access device and the blood collection device.

Description

[Technical field]

[0001] The present invention relates to a blood saving (SAVING) blood collection device.

[0002] This application claims priority to U.S. Provisional Application No. 63 / 332,476, entitled "Blood Saving Blood Collection Device," filed April 19, 2022, the entire disclosure of which is incorporated herein by reference in its entirety.

[0003] The present disclosure relates generally to blood sampling using vascular access devices. More specifically, the present disclosure relates to blood sampling configurations that allow for the return of "waste blood" samples to a patient via vascular access devices such as, for example, IV catheters, midlines, and central lines. [Background technology]

[0004] Phlebotomy is a common medical procedure that involves drawing at least one drop of blood from a patient. Blood samples are typically taken from hospitalized, at-home, and emergency room patients by fingerstick, heel stick, or venipuncture. Once collected, the blood sample is analyzed via one or more blood test levels.

[0005] Despite rapid advances in point-of-care testing and diagnostics, blood collection technology has remained relatively unchanged. Blood samples are frequently taken using a hypodermic needle, or a vacuum tube coupled to the proximal end of a needle or catheter assembly (i.e., a vascular access device). In some instances, clinicians collect blood from the catheter assembly using a needle and syringe inserted into the catheter and then draw blood from the patient through the inserted catheter. Typically, blood collection using existing vascular access devices requires that a portion of "waste blood" be disposed of after collection. Such wasted blood loss may be undesirable for a variety of reasons, including patient size (e.g., neonates), severe anemia, frequency of blood collection, previous blood loss, and / or other complicating factors.

[0006] Therefore, to avoid wasting blood samples, some clinicians choose to collect samples via traditional venipuncture blood collection, which does not involve the collection of waste blood. However, venipuncture blood collection requires a needle prick each time a sample is collected, which can cause pain and anxiety to patients, especially when multiple samples are required over time. Summary of the Invention

[0007] Accordingly, the present disclosure generally relates to a blood collection device for use in drawing blood via a vascular access device and associated assemblies, systems, and methods configured to collect a waste blood sample, temporarily store the waste blood sample, and return the waste blood to a patient via the vascular access device.

[0008] According to an embodiment of the present disclosure, a blood collection assembly is disclosed that can be coupled to a vascular access device. The blood collection assembly may include a blood collection device having a first branch, a second branch, a third branch, and a channel configured for fluid communication between the branches of the first branch, the second branch, and the third branch, and a syringe having a syringe body, a plunger, and a stopper, the plunger and the stopper being compressible and retractable within the syringe body, and the syringe being coupled to the first branch of the blood collection device. The assembly may also include a test sample collection device coupled to the second branch of the blood collection device, and an access portion coupled to the third branch of the blood collection device and configured to provide fluid communication between the vascular access device and the blood collection device.

[0009] In some embodiments, the blood collection device further includes a valve member, where rotation of the rotatable valve member switches fluid communication of the channel from communication between the first branch and the third branch to communication between the second branch and the third branch.

[0010] In some embodiments, the channel is a T-shaped channel.

[0011] In some embodiments, the valve member is selectively rotatable via a rotatable knob.

[0012] In some embodiments, the test sample collection device comprises a luer lock access device.

[0013] In some embodiments, the test sample collection device comprises a male-male luer connector.

[0014] In some embodiments, the access portion comprises a flexible tube and a luer access connector disposed at a distal end of the flexible tube.

[0015] In some embodiments, the blood collection device further comprises a compressible bulb disposed proximate to the third branch and in fluid communication with the channel.

[0016] In some embodiments, the test sample collection device includes a compressible valve device, the compressible valve device being removably coupled to a second branch of the blood collection device.

[0017] In some embodiments, the compressible valve device includes a nozzle and a connection interface, the connection interface configured to couple the compressible valve device to an outer surface of the second branch, and the nozzle configured to extend into the second branch to be in fluid communication with the channel.

[0018] In some embodiments, the blood collection device further includes a one-way valve disposed in the second branch, the one-way valve configured to close when the compressible valve device is removed from the blood collection device and to open when the compressible valve device is attached to the blood collection device.

[0019] In some embodiments, the nozzle of the compressible valve device is configured to penetrate the one-way valve.

[0020] In some embodiments, the syringe includes an air trap portion.

[0021] According to another aspect of the present disclosure, a blood testing and diagnostic platform is disclosed, the blood testing and diagnostic platform including a point-of-care testing device configured to be fluidly coupled to a vascular access device, a coupling member extending between the point-of-care testing device and the vascular access device, and a waste blood reservoir disposed within the point-of-care testing device, the waste blood reservoir fluidly coupled to the coupling member via a first branch. The platform also includes a blood testing region disposed within the point-of-care testing device, the blood testing region fluidly coupled to the coupling member via a second branch, and may include a valve disposed on the coupling member, the valve switchable to selectively open and close the first branch and the second branch.

[0022] In some embodiments, the point-of-care testing device further includes an integrated blood testing portion.

[0023] In some embodiments, the integrated blood testing portion includes at least one of a chemical test and an electronic sensor-based test.

[0024] In some embodiments, the blood testing area is removable from the point-of-care device.

[0025] In some embodiments, the point-of-care device is configured to both draw a waste blood sample into a waste blood reservoir prior to collection of a test blood sample and to inject the waste blood sample into a patient after a test blood sample has been collected at a blood testing area.

[0026] According to another aspect of the present disclosure, a method of collecting a blood sample from a patient through a vascular access device is disclosed. The method may include providing a blood collection assembly, the blood collection assembly including a blood collection device including a first branch, a second branch, a third branch, and a channel configured for fluid communication between the branches of the first branch, the second branch, and the third branch, a syringe including a syringe body, a plunger, and a stopper, the plunger and the stopper being compressible and retractable within the syringe body, the syringe being coupled to the first branch of the blood collection device, the test sample collection device being coupled to the second branch of the blood collection device, and the access portion being coupled to the third branch of the blood collection device, configured to provide fluid communication between the vascular access device and the blood collection device. The method may further include retracting the plunger of the syringe to draw the effluent blood sample into the syringe body, collecting the test blood sample through the test sample collection device, and compressing the plunger of the syringe to inject the effluent blood sample into the patient.

[0027] In some embodiments, the method further includes switching a valve member in the blood collection device after drawing the waste blood sample into the syringe body and prior to collecting the test blood sample.

[0028] Further details and advantages of the present invention will become apparent from the following detailed description taken in conjunction with the accompanying drawings, in which like parts are designated with like reference numerals throughout. [Brief description of the drawings]

[0029] [Figure 1] FIG. 1 is a perspective view of a blood collection assembly according to an embodiment of the present disclosure. [Diagram 2] FIG. 2 is a perspective view of a blood collection device according to another embodiment of the present disclosure. [Diagram 3] FIG. 3 is a top view of the blood collection device of FIG. 2 in a first configuration. [Figure 4] FIG. 4 is a cross-sectional view of a blood collection assembly according to another embodiment of the present disclosure. [Diagram 5] 5 is a cross-sectional view of a compressible valve device that can be used in the blood collection assembly of FIG. [Figure 6] 6 is a cross-sectional view of a syringe usable in the blood collection assembly of FIG. [Figure 7] FIG. 7 is a schematic diagram of a blood testing and diagnostic platform according to another embodiment of the present disclosure. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0030] The following description is provided to enable a person skilled in the art to make and use the described embodiments contemplated for carrying out the invention. However, various modifications, equivalents, variations, and alternatives will remain readily apparent to those skilled in the art. Any and all such modifications, variations, equivalents, and alternatives are intended to be within the spirit and scope of the present disclosure.

[0031] For purposes of description hereinafter, the terms "top", "bottom", "right", "left", "vertical", "horizontal", "top", "bottom", "transverse", "vertical", and their derivatives shall refer to the present invention as oriented in the drawings. However, it will be understood that the present invention may be subject to various alternative modifications unless expressly specified to the contrary. It should also be understood that the specific devices illustrated in the accompanying drawings and described in the following specification are merely exemplary embodiments of the present invention. As such, specific dimensions and other physical characteristics relating to aspects disclosed herein are not to be considered as limiting.

[0032] In this disclosure, the distal end of a component or device means the end furthest from the user's hand when the component or device is in the position for use, i.e., when a user is holding the syringe in preparation for or during use, and the proximal end means the end closest to the user's hand. Similarly, in this application, the terms "distally" and "distally" mean a direction toward the vascular access device, and the terms "proximally" and "proximally" mean a direction away from the vascular access device.

[0033] Although not shown or described herein, it should be understood that the blood collection devices described below may be utilized to collect blood from any suitable vascular access device, such as, for example, the BD NEXIVA™ Closed IV Catheter System, the BD CATHENA™ Catheter System, the BD VENFLON™ Pro Safely Shielded IV Catheter System, the BD NEOFLON™ IV Cannula System, the BD INSYTE™ AUTOGUARD™ BC Shielded IV Catheter System, or another suitable vascular access device.

[0034] Embodiments of the present disclosure are described primarily in the context of a fluid transfer device for use with a PIVC, however, embodiments of the present disclosure extend equally to use with other catheter devices.

[0035] 1-3, a blood collection assembly 10 according to one embodiment of the present disclosure is shown. The blood collection assembly 10 includes a blood collection device 20 configured to be coupled to a vascular access device, such as, for example, a PIVC. As described in further detail below, the blood collection device 20 allows for the collection of a bleed blood sample, followed by a test blood sample via, for example, a Luer Lock Access Device (LLAD), a point-of-care testing device, or the like, and then the return of the bleed blood sample to the patient via the vascular access device.

[0036] As shown in FIGS. 1-3, blood collection device 20 may be configured as a T-shaped connector member having a first branch 24, a second branch 25, and a third branch 26. However, while blood collection device 20 is shown as a T-shape, it should be understood that other configurations (e.g., Y-shape) are possible and blood collection device 20 is not limited to three branches. Blood collection device 20 further includes a user-positionable valve member 22 disposed at the intersection of branches 24, 25, 26. Valve member 22 may be configured as a stopcock valve or any other suitable switchable valve. In some embodiments, valve member 22 includes a rotatable knob configured to rotate at least 90°, and rotation of valve member 22 is configured to rotate T-shaped channel 23 formed within valve member 22 between at least two positions, a first position fluidly coupling branches 24 and 26 (as shown in FIG. 3) and a second position fluidly coupling branches 24 and 25. 1-3 depict valve member 22 as a rotatable knob, it should be understood that any suitable valve configuration capable of selectively switching fluid access between branches 24, 25, 26 may be utilized in accordance with the present disclosure.

[0037] In some embodiments, the first branch 24 of the blood collection device 20 may be coupled to a length of flexible tubing 34 and disposed with a connector 36 at the distal end of the tubing 34. The connector 36 may be any suitable connector, such as, for example, a Luer access connector, capable of removably coupling the blood collection assembly 10 to a vascular access device (not shown) to allow fluid passage between the vascular access device and the blood collection device 20. In some embodiments, the tubing 34 may be adjusted in length and diameter to prevent hemolysis. Alternatively, in other embodiments, the tubing 34 may be omitted and the blood collection device 20 may be substantially directly coupled to the vascular access device.

[0038] The blood collection assembly 10 further includes a syringe 12 having a plunger 14 and a stopper 16 slidably disposed therein for manual actuation by a clinician or other user. The syringe 12 includes a tip portion 18 configured to provide an inlet / outlet from a fluid chamber formed within the syringe 12. Although not shown, the chamber of the syringe 12 may include a chemical stabilizer (e.g., heparin, citrate, etc.) to substantially prevent clotting of blood stored therein. The tip portion 18 is configured to be removably coupleable to a third branch 26 via any suitable connection method, such as, for example, a press-fit connection, a luer connection, etc. Additionally, although not shown, in some embodiments, the syringe 12 may include, for example, one or more mechanisms to prevent the plunger 14 from being completely removed, a mechanism to enable turbulent mixing of the blood and the chemical stabilizer, a mechanically actuated vacuum section to enable passive blood collection (draw), and / or a low pressure two-way septum / valve configured to isolate the chamber / reservoir of the syringe.

[0039] With reference to FIG. 1 , in some embodiments, the blood collection assembly 10 may also include a blood sample collection interface, such as, for example, a Luer lock access device 30. In some embodiments, the Luer lock access device 30 is removably coupleable to the second branch 25 of the blood collection device 20 via a Luer lock hub 28. However, in other embodiments, the Luer lock access device 30 may be integrated with the blood collection device 20. As shown, the Luer lock access device 30 is configured to receive a blood collection device, such as, for example, a BD VACUTAINER® blood collection tube. The Luer lock access device 30 includes a needle 31 in fluid communication with the Luer lock hub 28 to allow fluid to selectively pass from the blood collection device 20 to a blood collection tube disposed within the Luer lock access device 30. Although not shown, it should be understood that the needle 31 may be substantially surrounded by a rubber sheath to protect against needlestick injury. The Luer lock access device 30 may include a holder sized and configured to accommodate, for example, a BD VACUTAINER® blood collection tube. In response to the blood collection tube pushing the sheath distally toward the Luer lock hub 28, the needle 31 can pierce the sheath and the sharp proximal tip of the needle 31 can be inserted into the blood collection tube to receive a blood sample via the venous access device, with the patient's venous pressure being sufficient to draw the sample into the evacuated blood collection tube.

[0040] Alternatively, referring to FIG. 2, in some embodiments, the second branch 25 of the blood collection device 20 may be coupled to other fittings, such as, for example, a male-male Luer connector 29. In this way, the blood collection assembly 10 is not limited to blood collection via a Luer lock access device and associated blood collection tube, but may instead be coupled to other sample collection devices, such as, for example, a miniature sample dispenser for use in point-of-care testing, etc. To dispense a small amount of blood sample via the connector 29, the blood collection device 20 may include a compressible bulb 32. When the compressible bulb 32 is pressed by a clinician or other user, a small amount of blood may be dispensed from the second branch 25, which is deliverable, for example, to a point-of-care testing device coupled to (or otherwise located near) the connector 29. In this way, the blood collection device 20 may be usable for both large volume sample collection (via the Luer lock access device 30 and associated vacuum tube, as shown in FIG. 1) and small volume sample collection. In some embodiments, the compressible bulb 32 may include a valve (not shown) to better enable dispensing.

[0041] 1-3, the operation of blood collection assembly 10 when coupled to a vascular access device will be described. First, with valve member 22 positioned such that first branch 24 and third branch 26 are fluidly coupled to one another via channel 23 and second branch 25 isolated therefrom (i.e., the configuration shown in FIG. 3), a clinician or other user utilizes syringe 12 to withdraw a waste blood sample by retracting plunger 14 until a desired amount of waste blood is collected within the chamber of syringe 12. As noted above, syringe 12 may include a chemical stabilizer (e.g., heparin, citrate, etc.) so that waste blood stored therein does not coagulate during the procedure. Additionally and / or alternatively, syringe 12 and / or blood collection device 20 may include a mechanical or electrical time limit lock (not shown) to prevent the release / injection of any blood held within syringe 12 beyond a predetermined maximum time limit.

[0042] After a desired amount of waste blood has been drawn into the syringe 12, the clinician may then rotate or otherwise actuate the valve member 22 such that the first branch 24 and the second branch 25 of the blood collection device 20 are in fluid communication via the channel 23 while leaving the third channel 26 (and thus the waste blood retained within the syringe 12) isolated therefrom. The clinician may then initiate blood collection and sample collection from the vascular access device, such as into a collection tube via the Luer lock access device 30 or into a small sample collection device for use in point-of-care testing. As discussed above, in some embodiments, the clinician may compress a valve 32 integrated into the blood collection device 20 to dispense a small amount of sample from the second branch 25.

[0043] Once the desired test blood sample has been collected via any suitable means, the clinician may then rotate the valve member 22 to its initial position, with the first branch 24 and the third branch 26 fluidly coupled to one another via the channel 23 and the second branch 25 isolated therefrom. Once the valve member 22 has returned to this position, the clinician may then depress the plunger 14 of the syringe 12, which injects the waste blood retained within the syringe 12 through the blood collection device 20 and back into the patient via the vascular access device. In this manner, the waste blood retained within the syringe 12 does not need to be discarded, which may be desirable in a variety of situations where further loss of blood needs to be avoided, such as, for example, small patient size (e.g., neonates, infants, etc.), patients with severe anemia, frequent blood draws, previous blood loss, and / or other complicating factors.

[0044] 4-6, there is shown a blood collection assembly 50 according to another embodiment of the present disclosure. Unlike blood collection assembly 10 described above with respect to Figures 1-3, which utilized a valve member to selectively fluidly couple a syringe to a venous access device, blood collection assembly 50 does not require a user-actuable valve to separate waste blood retained within the syringe.

[0045] The blood collection assembly 50 includes a blood collection device 60 configured to be coupled to a vascular access device, such as, for example, a PIVC. The blood collection device 60 allows a waste blood sample to be collected, followed by a test blood sample, for example, via a removable compressible valve, and then the waste blood sample is returned to the patient via the vascular access device. The blood collection device 60 may be configured as a T-shaped connector member having a first branch 62, a second branch 64, and a third branch 67. However, while the blood collection device 60 is shown as a T-shape, it should be understood that other configurations (e.g., Y-shape) are possible and the blood collection device 60 is not necessarily limited to three branches. A channel 66 is formed in the blood collection device 60, the channel 66 providing a fluid connection between each of the first branch 62, the second branch 64, and the third branch 67.

[0046] In some embodiments, the second branch 64 of the blood collection device 60 may be coupled to a vascular access device (not shown) via a Luer access device 68, which allows for fluid passage between the vascular access device and the blood collection device 60. In some embodiments, a tube may extend between the Luer access device 68 and the vascular access device, and the tube may be adjusted in length and diameter to prevent hemolysis. Alternatively, in other embodiments, the tube may be omitted and the blood collection device 60 may be substantially directly coupled to the vascular access device via the Luer access device 68.

[0047] The blood collection assembly 50 further includes a syringe 52 having a plunger 54 and a stopper 56 slidably disposed therein for manual actuation by a clinician. The syringe 52 includes a tip portion 58 configured to provide an inlet / outlet from a fluid chamber formed within the syringe 52. Although not shown, the chamber of the syringe 52 may include a chemical stabilizer (e.g., heparin, citrate, etc.) to substantially prevent clotting of blood stored therein. The tip portion 58 is configured to be removably coupleable to a first branch 62 of the blood collection device 60 via any suitable connection method, such as, for example, a press-fit connection, a luer connection, etc. Additionally, although not shown, in some embodiments, the syringe 52 may include, for example, one or more mechanisms to prevent the plunger 54 from being completely removed, a mechanism to allow turbulent mixing of the blood and the chemical stabilizer, a mechanically actuated vacuum section to allow passive blood collection, and / or a low pressure two-way septum / valve configured to isolate the syringe chamber / reservoir.

[0048] 4 and 5 , blood collection assembly 50 further includes a compressible valve device 72. Compressible valve device 72 is configured to be removably couplable to third branch 67 of blood collection device 60 via a connection interface 74. Connection interface 74 may be any suitable interface, such as, for example, a luer fitting, a snap-fit ​​connection, a threaded connection, a press-fit connection, etc. Compressible valve device 72 includes a nozzle portion 73 extending from a distal end thereof, which provides an inlet and an outlet to compressible valve device 72.

[0049] As shown in Fig. 5, the third branch 67 may include a one-way valve 70 that is normally closed when the compressible valve device 72 is removed from connection with the third branch 67. In this manner, fluid can pass between the first branch 62 and the second branch 64 of the blood collection device 60 without leaking from the third branch 67. However, when the compressible valve device 72 is coupled to the third branch 67 (as shown in Fig. 4), the nozzle portion 73 of the compressible valve device 72 is configured to penetrate the one-way valve 70, thereby placing the interior chamber of the compressible valve device 72 in fluid communication with the channel 66 of the blood collection device 60.

[0050] The operation of the blood collection assembly 50 according to one embodiment of the present disclosure will now be described. First, when the compressible valve device 72 is removed from the third branch 67 such that the one-way valve is closed (as shown in FIG. 5), the clinician utilizes the syringe 52 to withdraw a waste blood sample by retracting the plunger 54 until a desired amount of waste blood is collected in the chamber of the syringe 52. As mentioned above, the syringe 52 may include a chemical stabilizer (e.g., heparin, citrate, etc.) so that the waste blood stored therein does not coagulate during the procedure. Additionally and / or alternatively, the syringe 52 and / or blood collection device 60 may include a mechanical or electrical timed lock to prevent the release / injection of any blood held in the syringe 52 beyond a predetermined maximum time limit.

[0051] After a desired amount of waste blood has been drawn into the syringe 52, the clinician can attach the compressible valve device 72 to the third branch 67 such that the compressible valve device 72 is in fluid communication with the channel 66. With the compressible valve device 72 attached, the clinician can then squeeze or otherwise compress the compressible valve device 72, allowing a vacuum to be applied to collect a small amount of blood from the venous access device within the compressible valve device 72. Due to the limited return flow from the chamber of the syringe 52, the waste blood stored therein is not drawn into the compressible valve device 72. The clinician can then remove the compressible valve device 72 from the blood collection device 60, allowing the compressible valve device 72 to immediately dispense a small amount of blood sample for point-of-care testing. Alternatively, in some embodiments, the compressible valve device 72 may be transported and stored for future testing. The clinician may obtain any desired number of blood samples using one or more removable compressible valve devices 72.

[0052] Once the desired test blood sample has been collected via one or more compressible valve devices 72, the clinician may remove the compressible valve device 72 such that the first branch 62 and the second branch 64 are again fluidly coupled to one another via the channel 66 and the third branch 67 is closed by the one-way valve 70. The clinician may then depress the plunger 54 of the syringe 52, which injects the waste blood retained within the syringe 52 through the blood draw device 60 and back into the patient via the vascular access device. In this manner, the waste blood retained within the syringe 52 does not need to be discarded, which may be desirable in a variety of situations where further loss of blood needs to be avoided, such as, for example, small patient size (e.g., neonates, infants, etc.), patients with severe anemia, frequent blood draws, previous blood loss, and / or other complicating factors.

[0053] 4 and 5, and with further reference to FIG. 6, the operation of the blood collection assembly 50 according to another aspect of the present disclosure will now be described. In some embodiments, the compressible valve device 72 may be pre-attached to the blood collection device 60 and is present even when the effluent blood sample is being collected. In such embodiments, the clinician again utilizes the syringe 52 to collect the effluent sample by retracting the plunger 54 until a desired amount of effluent has been collected within the chamber of the syringe 52. Retraction of the plunger 54 also acts to draw air from the attached compressible valve device 72 and into the syringe 52.

[0054] Once the desired amount of effluent blood has been collected, the clinician may stop retracting the plunger 54, which allows the compressible valve device 72 to automatically re-expand and fill with blood via the venous access device. The clinician may then remove the compressible valve device 72 from the blood collection device 60, allowing the compressible valve device 72 to immediately dispense a small blood sample for point-of-care testing or to be transported and stored for future testing. After removing the compressible valve device 72, the clinician may depress the plunger 54 of the syringe 52, which injects the effluent blood retained within the syringe 52 via the blood collection device 60 and into the patient via the vascular access device.

[0055] As noted above, retraction of plunger 54 while compressible valve device 72 is coupled to blood collection device 60 causes air within compressible valve device 72 to be drawn into the chamber of syringe 52. To prevent air from entering the patient's bloodstream when waste blood is returned to the patient via depression of plunger 54, syringe 52 (in conjunction with the shape of stopper 56) may be configured to have an air trapping portion 57, as shown in FIG. 6. Thus, when plunger 54 is fully depressed to return the waste blood sample to the patient's vasculature, air trapping portion 57 retains the air previously drawn from compressible valve device 72 within syringe 52, thereby preventing that air from entering the patient's bloodstream.

[0056] 7, a blood testing and diagnostic platform 100 according to another aspect of the present disclosure is shown. In some embodiments, blood testing and diagnostic platform 100 includes a point-of-care testing device 102 that is configured to be fluidly coupled to a vascular access device (not shown) via a coupling member 104. Coupling member 104 may be any suitable coupler or connector and / or tubing combination.

[0057] The point-of-care testing device 102 may include a waste blood reservoir 106, which is fluidly coupled to the coupling member 104 via a first branch 107. Additionally, the point-of-care testing device 102 may include a blood testing area 108. In some embodiments, the blood testing area 108 is integrated within the point-of-care testing device 102. In other embodiments, the blood testing area 108 is removable from the point-of-care testing device 102 and thus replaceable. The blood testing area 108 is fluidly coupled to the coupling member 104 via a second branch 109. A valve 112 is provided, which is selectively switchable to selectively open and close the first branch 107 and the second branch 109. In this manner, the fluid connection between the vascular access device, the waste blood reservoir 106, and the blood testing area 108 may alternate based on the position of the valve 112. Valve 112 may be actuated by any suitable method, including manual switching, automatic (electrical) switching, and the like.

[0058] The point-of-care testing device 102 adjacent to and / or coupled to the testing area 108 may include an integrated blood testing portion 110. The blood testing portion 110 may include any suitable point-of-care testing functionality, such as, for example, chemistry tests, electronic sensor-based tests, and / or other diagnostic tests.

[0059] The operation of the blood testing and diagnostic platform 100 according to one embodiment of the present disclosure will now be described. First, with the coupling member 104 connected to the vascular access device, the valve 112 is set such that the first branch 107 leading to the waste blood reservoir 106 is open and the second branch 109 leading to the blood testing area 108 is closed. A desired amount of the waste blood sample is then drawn into the waste blood reservoir 106 via any suitable method, e.g., pump, syringe, etc. The waste blood reservoir 106 may include a chemical stabilizer (e.g., heparin, citrate, etc.) so that the waste blood stored therein does not coagulate during the procedure. Additionally and / or alternatively, the blood testing and diagnostic platform 100 may include a mechanical or electrical time limit lock to prevent the release / injection of any blood held in the waste blood reservoir 106 beyond a predetermined maximum time limit.

[0060] After a desired amount of waste blood has been drawn into the waste blood reservoir 106, the valve 112 is switched such that the second branch 109 leading to the blood testing area 108 is opened while the first branch 107 is closed. A blood sample may then be collected in / on the blood testing area 108. In some embodiments, testing and / or diagnosis of the blood collected by the blood testing area 108 is performed in the integrated blood testing portion 100. In other embodiments, the blood testing area 108 may be removed from the blood testing and diagnostic platform 100 after testing via the integrated blood testing portion 100 and / or to perform testing remotely. If the blood testing area 108 is removable, the removed blood testing area 108 may be replaced after blood collection and testing.

[0061] Once the desired test blood sample has been collected in / on the blood testing area 108 and testing by the integrated blood testing portion 100 is completed, the valve 112 can be switched again such that the first branch 107 is open while the second branch 109 is closed. In this position, the waste blood retained in the waste blood reservoir 106 can be returned to the patient via the vascular access device. In this manner, the waste blood retained in the waste blood reservoir 106 does not need to be discarded, which may be desirable in various situations where further loss of blood needs to be avoided.

[0062] Although several embodiments of a blood collection assembly configured for the collection (and return) of waste blood have been described in the foregoing detailed description, those skilled in the art may make modifications and variations to these embodiments without departing from the scope and spirit of the invention. Accordingly, the foregoing description is intended to be illustrative rather than limiting. The invention described above is defined by the appended claims, and all changes to the invention that come within the meaning and range of equivalency of the claims are embraced within their scope.

Claims

1. 1. A blood collection assembly coupleable to a vascular access device, the blood collection assembly comprising: a blood collection device comprising a first branch, a second branch, a third branch, and a channel configured for fluid communication between the first branch, the second branch, and the third branch; a syringe comprising a syringe body, a plunger, and a stopper, the plunger and the stopper being compressible and retractable within the syringe body, the syringe being coupled to the first branch of the blood collection device; a test sample collection device coupled to the second branch of the blood collection device; an access portion coupled to the third branch of the blood collection device and configured to provide fluid communication between the vascular access device and the blood collection device; A blood collection assembly comprising:

2. 2. The blood collection assembly of claim 1, wherein the blood collection device further comprises a valve member, wherein rotation of the rotatable valve member switches fluid communication of the channel from communication between the first branch and the third branch to communication between the second branch and the third branch.

3. The blood collection assembly of claim 2 , wherein the channel is a T-shaped channel.

4. The blood collection assembly of claim 2 , wherein the valve member is selectively rotatable via a rotatable knob.

5. The blood collection assembly of claim 1 , wherein the test sample collection device comprises a luer lock access device.

6. The blood collection assembly of claim 1 , wherein the test sample collection device comprises a male-male Luer connector.

7. The blood collection assembly of claim 1 , wherein the access portion comprises a flexible tube and a luer access connector disposed at a distal end of the flexible tube.

8. The blood collection assembly of claim 1 , wherein the blood collection device further comprises a compressible valve disposed proximate to the third branch and in fluid communication with the channel.

9. The blood collection assembly of claim 1 , wherein the test sample collection device includes a compressible valve device, the compressible valve device being removably coupled to the second branch of the blood collection device.

10. 10. The blood collection assembly of claim 9, wherein the compressible valve device includes a nozzle and a connection interface, the connection interface configured to couple the compressible valve device to an outer surface of the second branch, and the nozzle configured to extend into the second branch so as to be in fluid communication with the channel.

11. 11. The blood collection assembly of claim 10, wherein the blood collection device further comprises a one-way valve disposed in the second branch, the one-way valve configured to close when the compressible valve device is removed from the blood collection device and to open when the compressible valve device is attached to the blood collection device.

12. The blood collection assembly of claim 11 , wherein the nozzle of the compressible valve device is configured to penetrate the one-way valve.

13. The blood collection assembly of claim 1 , wherein the syringe comprises an air trap portion.

14. 1. A blood testing and diagnostic platform comprising: a point-of-care testing device configured to be fluidly coupled to the vascular access device; a coupling member extending between the point-of-care testing device and the vascular access device; a waste blood reservoir disposed within the point-of-care testing device, the waste blood reservoir fluidly coupled to the coupling member via a first branch; a blood testing area disposed within the point-of-care testing device, the blood testing area fluidly coupled to the coupling member via a second branch; and a valve on the coupling member, the valve being switchable to selectively open and close the first branch and the second branch; and A blood testing and diagnostic platform comprising:

15. 15. The blood testing and diagnostic platform of claim 14, wherein the point-of-care testing device further comprises an integrated blood testing portion.

16. 16. The blood testing and diagnostic platform of claim 15, wherein the integrated blood testing portion includes at least one of a chemical test and an electronic sensor-based test.

17. 15. The blood testing and diagnostic platform of claim 14, wherein the blood testing area is detachable from the point-of-care device.

18. 15. The blood testing and diagnostic platform of claim 14, wherein the point-of-care device is configured to both draw a waste blood sample into the waste blood reservoir prior to collection of a test blood sample and to inject the waste blood sample into a patient after a test blood sample is collected at the blood testing area.

19. 1. A method of collecting a blood sample from a patient via a vascular access device, comprising: A blood collection assembly is provided, the blood collection assembly comprising: a blood collection device comprising a first branch, a second branch, a third branch, and a channel configured for fluid communication between the first branch, the second branch, and the third branch; a syringe comprising a syringe body, a plunger, and a stopper, the plunger and the stopper being compressible and retractable within the syringe body, the syringe being coupled to the first branch of the blood collection device; a test sample collection device coupled to the second branch of the blood collection device; an access portion coupled to the third branch of the blood collection device and configured to provide fluid communication between the vascular access device and the blood collection device; retracting the plunger of the syringe to draw a waste blood sample into the syringe body; collecting a test blood sample via the test sample collection device; compressing the plunger of the syringe to reinject the discarded blood sample into the patient; A method comprising:

20. 20. The method of claim 19, further comprising switching a valve member in the blood collection device after drawing the waste blood sample into the syringe body and before collecting the test blood sample.

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