Blood Access Device with Integrated Blood Diagnostics

Abstract

The blood sample collection system includes a blood access device having a fluid flow path and a diagnostic device configured to receive a sample of blood, the diagnostic device in fluid communication with the fluid flow path, and the diagnostic device configured to be disconnected from the blood access device.

Description

[Technical field]

[0001] The present disclosure relates to blood access devices with integrated blood diagnostics. [Background technology]

[0002] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to U.S. Provisional Application No. 63 / 317,304, entitled "BLOOD ACCESS DEVICE WITH INTEGRATED BLOOD DIAGNOSTICS," filed March 7, 2022, the entire disclosure of which is incorporated herein by reference in its entirety.

[0003] Catheters are frequently used to administer fluids to and from the body. Patients in a variety of settings, including hospitals and home care, receive fluids, medicines, and blood products via vascular access devices inserted into the patient's vascular system. Catheters of various types and sizes are widely used in a variety of procedures, including, but not limited to, treating infections, providing anesthesia or analgesia, providing nutritional support, treating cancerous growths, maintaining blood pressure and cardiac rhythm, and many other clinical applications. A common vascular access device is a plastic catheter that is inserted into a patient's vein. The length of the catheter can vary from a few centimeters for peripheral access to tens of centimeters for central access. Catheters are commonly incorporated into a catheter adapter to aid in the ease of use, accessibility, and usefulness of the catheter. The catheter adapter can be adapted to accommodate one end of the catheter such that one end of the catheter is supported by the catheter adapter and the body and tip of the catheter extend beyond the first end of the catheter adapter. The catheter adapter generally further includes a second end adapted to receive an additional infusion component for use with the catheter. For example, the second end of the catheter adapter may include a series of threads for attaching an intravenous line or for coupling a syringe to the catheter adapter, thereby providing access to the patient's vascular system via the attached catheter.

[0004] The catheter may be inserted percutaneously. When inserted percutaneously, insertion of the catheter is generally assisted by an introducer needle. The introducer needle is generally housed within the lumen of the catheter such that the gauge of the needle approximates the inner diameter of the catheter. The needle is positioned within the catheter such that the needle tip extends beyond the tip of the catheter, whereby the needle is used to pierce the patient's vein and provide an opening for insertion of the catheter.

[0005] To verify proper placement of the introducer needle and / or catheter within the blood vessel, the clinician will typically confirm that there is a "flashback" of blood within the flashback chamber of the catheter assembly. Once needle placement is confirmed, the clinician may temporarily occlude flow within the vasculature and remove the needle, leaving the catheter in place for subsequent blood draws, infusions or probe access.

[0006] Recent developments in the peripheral intravenous catheter (PIVC) field have led to the emergence of technologies designed to facilitate blood collection and indwelling PIVC. These devices focus on the ability to reliably collect high-quality blood samples and reduce hemolysis. The primary way these devices work is by inserting a guidewire, probe, tube, or other instrument into the lumen of the catheter. This placement creates a fluid pathway through any blood clots or fibrin that may be occluding the tip of the catheter. A syringe or evacuated blood collection tube can then be used to collect the blood sample without the need to expose the patient to an additional needlestick.

[0007] Point-of-care (POC) testing involves the use of portable testing systems that can rapidly provide results using small blood samples, such as glucose testing. Blood samples are typically collected via finger pricks or through existing vascular access. However, most vascular access devices are not optimized for the collection of small blood samples. The current field is moving toward personalized healthcare, with the goal of POC testing that can provide rapid diagnostic results with smaller blood volumes. In anticipation of the increase in POC diagnostic testing, there is a need to provide POC blood sample collection options from PIVCs.

[0008] The subject matter claimed herein is not limited to embodiments that solve any shortcomings or that operate only in such environments. Rather, this background is only provided to illustrate one example technology area where some implementations described herein may be practiced. [Prior art documents] [Patent documents]

[0009] [Patent Document 1] U.S. Pat. No. 11,090,461 [Patent Document 2] US Patent Application Publication No. 2021 / 10186394 Summary of the Invention

[0010] In one aspect or embodiment, a blood sample collection system includes a blood access device having a fluid flow path and a diagnostic device configured to receive a blood sample, the diagnostic device in fluid communication with the fluid flow path, and the diagnostic device configured to be disconnected from the blood access device.

[0011] The blood access device may include a housing, an instrument disposed within the housing, and an advancing element configured to advance the instrument beyond a distal end of the housing in response to movement of the advancing element relative to the housing.

[0012] The diagnostic device may be configured to receive a sample volume of 0.3 to 500 microliters. The diagnostic device may be configured to receive a sample volume of 0.3 to 100 microliters. The blood access device may be a peripheral intravenous catheter. The blood access device may include an extension tube. The diagnostic device may be a diagnostic test cartridge.

[0013] The blood access device may include one of the cannula and the septum, and the diagnostic test cartridge includes the other of the cannula and the septum, the cannula configured to extend through the septum and place the fluid flow path of the blood access device in fluid communication with the diagnostic test cartridge. The body of the diagnostic test cartridge may be cylindrical. The body of the diagnostic test cartridge may be planar.

[0014] The advancement element may include a cannula and the diagnostic device may include a septum, the cannula configured to extend through the septum and place the fluid flow path of the blood access device in fluid communication with the diagnostic device. The housing of the blood access device may include a distal opening configured to receive at least a portion of the diagnostic device. The instrument may include a flow tube or a helical coil. The diagnostic device may be a diagnostic test strip, a lateral flow assay, or a visual indicator.

[0015] In a further aspect or embodiment, a blood sample collection system includes a medical connector having a fluid flow path and a diagnostic device configured to receive a blood sample, the diagnostic device in fluid communication with the fluid flow path, and the diagnostic device configured to be detached from the medical connector.

[0016] The medical connector may include one of a male luer connector and a female luer connector, and the diagnostic device may include the other of the male luer connector and the female luer connector. The medical connector may be a needleless medical connector. The diagnostic device may be a diagnostic test cartridge. [Brief description of the drawings]

[0017] The above and other features and advantages of the present disclosure, as well as the manner in which they are accomplished, will become more apparent, and the disclosure itself will be better understood, by reference to the following description of embodiments of the disclosure taken in conjunction with the accompanying drawings, in which: [Figure 1] FIG. 1 is a top view of a blood access device and a diagnostic cartridge according to one aspect or embodiment of the present application. [Diagram 2] FIG. 2 is a top view of the blood access device and diagnostic cartridge of FIG. 1 showing a post-advance position of the blood access device. [Diagram 3] 3 is a top view of the blood access device and diagnostic cartridge of FIG. 1 showing the post-advance position of the blood access device and blood within the diagnostic cartridge. [Figure 4] FIG. 4 is a top view of the blood access device and diagnostic cartridge of FIG. 1 showing the stored position of the blood access device and removal of the diagnostic cartridge. [Diagram 5] FIG. 5 is a front view of a testing device according to one aspect or embodiment of the present application, showing a diagnostic cartridge being inserted into the testing device. [Figure 6A] FIG. 6A is a front view of the blood access device and diagnostic cartridge of FIG. 1, showing a post-advance position without the diagnostic cartridge. [Figure 6B] FIG. 6B is a front view of the blood access device of FIG. 1 showing an advanced position with a diagnostic cartridge. [Figure 6C]6C is a front view of the blood access device of FIG. 1 showing an advanced position with blood received within the diagnostic cartridge. [Figure 6D] FIG. 6D is a front view of the blood access device of FIG. 1 showing an advanced position with the diagnostic cartridge removed. [Figure 6E] FIG. 6E is a front view of the blood access device of FIG. 1 showing an advanced position with an additional diagnostic cartridge installed. [Figure 7] FIG. 7 is a front view of a blood access device and diagnostic cartridge according to one aspect or embodiment of the present application. [Figure 8] FIG. 8 is a front view of a blood access device and diagnostic cartridge according to a further aspect or embodiment of the present application. [Figure 9] FIG. 9 is a perspective view of a blood access device and diagnostic cartridge according to a further aspect or embodiment of the present application. [Figure 10] 10 is a cross-sectional view of the blood access device and diagnostic cartridge of FIG. [Figure 11] FIG. 11 is a perspective view of the blood access device and diagnostic cartridge of FIG. 9 showing blood in the diagnostic cartridge. [Figure 12A] FIG. 12A is a top view of a blood access device and a diagnostic test strip according to one aspect or embodiment of the present application. [Figure 12B] FIG. 12B is a top view of the blood access device and diagnostic test strip of FIG. 12A showing a post-advance position of the blood access device. [Figure 12C] FIG. 12C is a top view of the blood access device and diagnostic test strip of FIG. 12A showing the stored position of the blood access device and removal of the diagnostic test strip. [Figure 13A] FIG. 13A is a top view of a blood access device and a lateral flow assay according to one aspect or embodiment of the present application. [Figure 13B]FIG. 13B is a top view of the blood access device and lateral flow assay of FIG. 13A showing a post-advance position of the blood access device and showing blood present in the lateral flow assay. [Figure 14A] FIG. 14A is a top view of a blood access device and diagnostic test according to an aspect or embodiment of the present application showing a post-advance position of the blood access device. [Figure 14B] FIG. 14B is a top view of the blood access device and diagnostic test of FIG. 14A showing the stored position of the blood access device and with blood present in the diagnostic test. [Figure 15A] FIG. 15A is a perspective view of the diagnostic test of FIG. 14A. [Figure 15B] 1 is a schematic diagram of a diagnostic test result key according to one aspect or embodiment of the present application. [Figure 16] FIG. 16 is a top view of a blood access device and diagnostic cartridge according to one aspect or embodiment of the present application, showing the large sample collection fluid path. [Figure 17A] FIG. 17A is a perspective view of a medical connector and diagnostic cartridge according to one aspect or embodiment of the present application. [Figure 17B] FIG. 17B is a perspective view of a medical connector and diagnostic cartridge according to one aspect or embodiment of the present application. [Figure 18] FIG. 18 is a schematic diagram of a syringe-based blood collection and diagnostic device according to one aspect or embodiment of the present application. [Figure 19] FIG. 19 is a front view of a blood access device and a diagnostic device according to one aspect or embodiment of the present application. [Figure 20] FIG. 20 is a front view of a blood access device and a diagnostic test strip according to one aspect or embodiment of the present application. [Figure 21] FIG. 21 is a perspective view of a blood access device and a diagnostic device according to one aspect or embodiment of the present application. [Figure 22]FIG. 22 is a schematic diagram of a blood access device and a diagnostic device according to one aspect or embodiment of the present application. [Diagram 23] FIG. 23 is a perspective view of a medical connector and diagnostic cartridge according to one aspect or embodiment of the present application.

[0018] Corresponding reference characters indicate corresponding parts throughout the several views. The illustrations presented herein illustrate exemplary embodiments of the present disclosure, and such illustrations are not to be construed as limiting the scope of the present disclosure in any way. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0019] Spatial or directional terms such as "left," "right," "inner," "outer," "above," "below," etc. should not be considered limiting as the present invention may contemplate various alternative orientations.

[0020] For purposes of explanation hereinafter, the terms "top", "bottom", "right", "left", "vertical", "horizontal", "top", "bottom", "transverse", "length" and their derivatives shall refer to the invention as oriented in the drawings. It will be understood, however, that the 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 invention.

[0021] Unless otherwise indicated, all ranges or ratios disclosed herein should be understood to encompass the starting and ending values, and any and all subranges or subratios contained therein. For example, a specified range or ratio of "1 to 10" should be considered to include any and all subranges or subratios between (and including) the minimum value of 1 and the maximum value of 10, i.e., all subranges or subratios begin with a minimum value of 1 or greater and end with a maximum value of 10 or less.

[0022] The terms "first," "second," and the like are not intended to refer to any particular order or chronology, but rather to different conditions, properties, or elements.

[0023] As used herein, "at least one" is synonymous with "one or more." For example, the phrase "at least one of A, B, and C" means any one of A, B, or C, or any combination of any two or more of A, B, or C. For example, "at least one of A, B, and C" includes one or more A alone, or one or more B alone, or one or more C alone, or one or more A and one or more B, or one or more A and one or more C, or one or more B and one or more C, or all of A, B, and C.

[0024] 1-6E, in one aspect or embodiment of the present application, a blood sample collection system 10 includes a blood access device 12 having a fluid flow path and a diagnostic device 14 configured to receive a blood sample. The diagnostic device 14 is in fluid communication with the fluid flow path and is configured to be removed from the blood access device 12.

[0025] In one aspect or embodiment, the blood access device 12 includes a housing 16, an instrument 18 disposed within the housing 16, and an advancement element 20. In response to movement of the advancement element 20 relative to the housing 16, the instrument 18 is configured to advance beyond the distal end of the housing 16. The instrument 18 may be a flow tube, although other suitable arrangements may be utilized. The blood access device 12 may be configured to connect to a peripheral intravenous catheter, a peripherally inserted central catheter, or a midline catheter. In one aspect or embodiment, the blood access device 12 is coupled to an indwelling catheter via a needleless connector (not shown). In some aspects or embodiments, the blood access device 12 may be a PIVO™ blood collection device commercially available from Velano Vascular. In one embodiment, the blood access device 12 is the same as or similar to the blood collection device shown in U.S. Patent No. 6,399,323, which is incorporated herein by reference in its entirety.

[0026] 1-5, during use, the blood sample collection system 10 is connected to an indwelling catheter with the blood access device 12 initially in a pre-advance or retracted position (FIG. 1). The instrument 18 of the blood access device 12 is moved or advanced to a post-advance position (FIG. 2) as the instrument 18 enters the patient's vasculature. Direct blood delivery to the diagnostic device 14 occurs with direct transfer of blood from the patient's vasculature to the diagnostic device 14 via venous pressure, as well as aeration within the fluid flow paths of the diagnostic device 14 or blood access device 12 (FIG. 3). Capillary action may provide additional blood sample movement within the microfluidic pathway of the diagnostic device 14. In some aspects or embodiments, the instrument 18 of the blood access device 12 is moved to a retracted position and the diagnostic device 14 is removed (FIG. 4). The diagnostic device 14 can then be placed in a diagnostic test fixture 22 (FIG. 5). In some aspects or embodiments, diagnostic device 14 is a diagnostic test cartridge, which may be the same as or similar to the i-STAT™ Chem8+ diagnostic test cartridge available from Abbott. In some aspects or embodiments, diagnostic test instrument 22 may be the same as or similar to the i-STAT™ Alinity diagnostic test instrument available from Abbott.

[0027] 6A-6E, blood access device 12 is configured to be advanced without diagnostic device 14 (FIG. 6A) or with diagnostic device 14 (FIG. 6B). After diagnostic device 14 receives a blood sample (FIG. 6C), diagnostic device 14 can be removed while instrument 18 remains in an advanced position (FIG. 6D). An additional diagnostic device 14 can then be attached to blood access device 12 (FIG. 6E) to obtain a second or additional blood sample.

[0028] 7 and 8, in one aspect or embodiment, blood access device 12 includes one of a cannula 30 and a septum 32, and diagnostic device 14 includes the other of the cannula 30 and the septum 32, with the cannula 30 configured to extend through the septum 32 and place the fluid flow path of blood access device 12 in fluid communication with diagnostic device 14. In FIG. 7, diagnostic device 14 includes septum 32, and blood access device 12 includes cannula 30. In FIG. 8, diagnostic device 14 includes cannula 30, and blood access device 12 includes septum 32.

[0029] 9-11 , in one aspect or embodiment, the advancement element 20 of the blood access device 12 includes a cannula 38 and the diagnostic device 14 includes a septum 40, where the cannula 38 is configured to extend through the septum 32 and place the fluid flow path of the blood access device 12 in fluid communication with the diagnostic device 14. The advancement element 20 may include a connector or other feature for receiving and holding the diagnostic device.

[0030] 12A-12C, in one aspect or embodiment, the diagnostic device 14 is a diagnostic test strip that can be advanced with an advancement element 20 (FIG. 12A), receive a blood sample (FIG. 12B), and then removed for diagnostic testing (FIG. 12C).

[0031] 13A and 13B, in one aspect or embodiment, the diagnostic device 14 is a lateral flow assay. The lateral flow assay may advance through an advancement element 20 and receive a blood sample, which may be shown via a blood visualization flashback chamber (FIG. 13B).

[0032] 14A-15B, in one aspect or embodiment, diagnostic device 14 is a visual diagnostic indicator. The visual diagnostic indicator may be advanced with advancement element 20 to receive a blood sample (FIG. 14A). The visual diagnostic indicator may remain attached to blood access device 12 or may be removable from blood access device 12. The visual diagnostic indicator includes a plurality of indicators 42 (FIG. 15A) that can be compared to a diagnostic test key 44 (FIG. 15B) to determine the outcome of the test.

[0033] 16, in one aspect or embodiment, the blood access device 12 includes an extension tube 48 configured to receive a larger volume of a blood sample. The extension tube 48 may include a tube clamp and / or various medical connectors.

[0034] 17A and 17B, in further aspects or embodiments, the diagnostic device 14 is connected to a medical connector 60 having a fluid flow path. The medical connector 60 may be directly connected to a catheter, an access port of an indwelling catheter or extension set, a venipuncture blood collection device, or may be connected to a blood access device via an extension tube. In some aspects or embodiments, the medical connector 60 includes a fluid path geometry configured to prevent hemolysis of the blood sample. In one aspect or embodiment, the fluid path geometry reduces the flow rate of blood in the fluid path, which in turn can reduce the shear rate for hemolysis management. In some aspects or embodiments, the medical connector 60 includes one of the flow path geometries shown and described in U.S. Patent Application Publication No. 2009 / 0133994, which is incorporated herein by reference in its entirety. The diagnostic device 14 may be cylindrical (FIG. 17A) or planar (FIG. 17B), although other suitable shapes and configurations may be utilized. The medical connector 60 may include a female luer connector 62, and the diagnostic device 14 may include a male luer connector 64 configured to connect to the female luer connector 62. The medical connector 60 may be a needleless medical connector.

[0035] 18-22, in a further aspect or embodiment, the housing 16 of the blood access device 12 includes a distal opening 70 configured to receive at least a portion of the diagnostic device 14. The diagnostic device 14 is disposed in fluid communication with the blood access device 12 via the distal opening 70. As shown in FIG. 22, the instrument 18 can be a helical coil 74 configured to transport fluid from the patient's vasculature to the blood access device 12 and the diagnostic device 14.

[0036] 23 , in a further aspect or embodiment, diagnostic device 14 includes an advancing element 80 connected to a tube 82 configured to advance the tube 82 over diagnostic device 14 in a manner similar to the implements of blood access device 12. Advancing element 80 and tube 82 may be used in conjunction with medical connector 60 described above, where tube 82 is configured to be pushed through a valve of medical connector 60.

[0037] In one aspect or embodiment, diagnostic device 14 is configured to receive a blood sample volume between 0.3 and 500 microliters. In one aspect or embodiment, diagnostic device 14 is configured to receive a blood sample volume between 0.3 and 100 microliters.

[0038] While the present invention has been described in detail for purposes of illustration based on what are presently considered to be the most practical and preferred embodiments or aspects, it is to be understood that such detail is for this purpose only, and that the present invention is not limited to the disclosed embodiments or aspects, but on the contrary, is intended to cover modifications and equivalent arrangements within the spirit and scope of the appended claims. For example, it is to be understood that the present invention contemplates that, to the extent possible, one or more features of any embodiment may be combined with one or more features of any other embodiment.

Claims

1. 1. A blood sample collection system comprising: a blood access device having a fluid flow path; 1. A blood sample collection system comprising: a diagnostic device configured to receive a sample of blood, the diagnostic device in fluid communication with the fluid flow path, the diagnostic device configured to be disconnected from the blood access device.

2. The blood access device comprises: Housing and an instrument disposed within the housing; 10. The blood sample collection system of claim 1, comprising: an advancing element configured to advance the instrument beyond a distal end of the housing in response to movement of the advancing element relative to the housing.

3. The blood sample collection system of claim 1 , wherein the diagnostic device is configured to receive a sample volume of between 0.3 and 500 microliters.

4. The blood sample collection system of claim 3 , wherein the diagnostic device is configured to receive a sample volume of between 0.3 and 100 microliters.

5. The blood sample collection system of claim 1 , wherein the blood access device comprises a peripheral intravenous catheter.

6. The blood sample collection system of claim 1 , wherein the blood access device includes an extension tube.

7. The blood sample collection system of claim 1 , wherein the diagnostic device comprises a diagnostic test cartridge.

8. 8. The blood sample collection system of claim 7, wherein the blood access device includes one of a cannula and a septum, and the diagnostic test cartridge includes the other of the cannula and the septum, and the cannula is configured to extend through the septum and position the fluid flow path of the blood access device in fluid communication with the diagnostic test cartridge.

9. 8. The blood sample collection system of claim 7, wherein the body of the diagnostic test cartridge is cylindrical.

10. 8. The blood sample collection system of claim 7, wherein the body of the diagnostic test cartridge is planar.

11. 3. The blood sample collection system of claim 2, wherein the advancement element comprises a cannula, the diagnostic device comprises a septum, and the cannula is configured to extend through the septum and place the fluid flow path of the blood access device in fluid communication with the diagnostic device.

12. The blood sample collection system of claim 2 , wherein the housing of the blood access device comprises a distal opening configured to receive at least a portion of the diagnostic device.

13. The blood sample collection system of claim 2 , wherein the device comprises a flow tube or a helical coil.

14. The blood sample collection system of claim 1 , wherein the diagnostic device comprises a diagnostic test strip.

15. The blood sample collection system of claim 1 , wherein the diagnostic device comprises a lateral flow assay.

16. The blood sample collection system of claim 1 , wherein the diagnostic device comprises a visual indicator.

17. 1. A blood sample collection system comprising: a medical connector having a fluid flow path; 1. A blood sample collection system comprising: a diagnostic device configured to receive a sample of blood, the diagnostic device in fluid communication with the fluid flow path, the diagnostic device configured to be detached from the medical connector.

18. 18. The blood sample collection system of claim 17, wherein the medical connector includes one of a male luer connector and a female luer connector, and the diagnostic device includes the other of the male luer connector and the female luer connector.

19. The blood sample collection system of claim 17 , wherein the medical connector comprises a needleless medical connector.

20. 20. The blood sample collection system of claim 17, wherein the diagnostic device comprises a diagnostic test cartridge.

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