US-12622616-B2 - Vascular access device blood draw system with septum access

Abstract

A system for blood draw including a catheter adapter having a catheter and a side inlet defining a fluid pathway into and out of the catheter. The system also includes a near-patient access port member having a main branch with a distal end couplable to the side inlet and a proximal end having a needle access connector coupled thereto. The system further includes a blood draw device removably couplable to the near-patient access port member, wherein the blood draw device includes a cannula configured to penetrate the needle access connector, a flow tube configured to be advanced and retracted through the cannula, and a tube advancement tab coupled to the flow tube and configured to linearly advance and retract the flow tube through the cannula such that the flow tube may be selectively directed through the blood draw device, the near-patient access port member, and the catheter adapter.

Inventors

• Jonathan Karl Burkholz

Assignees

• BECTON, DICKINSON AND COMPANY

Dates

Publication Date

20260512

Application Date

20230120

Claims (20)

1. 1 . A system for blood draw comprising: a catheter adapter comprising a catheter configured to be inserted into a patient's vasculature and a side inlet defining a fluid pathway into and out of the catheter; a near-patient access port member having a main branch comprising a distal end couplable to the side inlet of the catheter adapter and a proximal end having a needle access connector coupled thereto; and a blood draw device removably couplable to the near-patient access port member, wherein the blood draw device comprises: a cannula configured to penetrate the needle access connector of the near-patient access port member; a flow tube configured to be advanced and retracted through the cannula; and a tube advancement tab coupled to the flow tube and configured to linearly advance and retract the flow tube through the cannula such that the flow tube is selectively directable through the blood draw device, the near-patient access port member, and the catheter adapter when the cannula of the blood draw device penetrates the needle access connector of the near-patient access port member.
2. 2 . The system of claim 1 , wherein the needle access connector comprises a septum.
3. 3 . The system of claim 2 , wherein the septum is external to the main branch of the near-patient access port member.
4. 4 . The system of claim 2 , wherein the septum is integrated within the main branch of the near-patient access port member.
5. 5 . The system of claim 2 , wherein the septum comprises an angled distal face within an interior of the main branch.
6. 6 . The system of claim 1 , wherein the cannula is one of a sharp metal needle, a blunt metal needle, or a blunt plastic cannula.
7. 7 . The system of claim 1 , wherein the blood draw device further comprises a distal connector interface configured to removably couple the blood draw device to the near-patient access port member.
8. 8 . The system of claim 7 , wherein the distal connector interface comprises a pair of connector clips.
9. 9 . The system of claim 7 , wherein the distal connector interface is configured to at least partially surround the cannula and form a safety shield around at least a portion of the cannula.
10. 10 . The system of claim 1 , wherein the blood draw device further comprises a safety shield configured to surround the cannula and be selectively removable from the cannula.
11. 11 . The system of claim 1 , wherein the near-patient access port member further comprises a side branch and an extension set coupled to the near-patient access port member via the side branch.
12. 12 . The system of claim 11 , wherein the side branch is distally-directed relative to the main branch.
13. 13 . The system of claim 11 , wherein the side branch is proximally-directed relative to the main branch.
14. 14 . A system for blood draw comprising: a catheter adapter comprising a catheter configured to be inserted into a patient's vasculature and a side inlet defining a fluid pathway into and out of the catheter; a near-patient access port member having a main branch comprising a distal end portion couplable to the side inlet of the catheter adapter and a proximal end portion having integrated septum therein; and a blood draw device removably couplable to the near-patient access port member, wherein the blood draw device comprises: a cannula configured to penetrate the integrated septum of the near-patient access port member; a flow tube configured to be advanced and retracted through the cannula; and a tube advancement tab coupled to the flow tube and configured to linearly advance and retract the flow tube through the cannula such that the flow tube is selectively directable through the blood draw device, the near-patient access port member, and the catheter adapter when the cannula of the blood draw device penetrates the integrated septum of the near-patient access port member.
15. 15 . The system of claim 14 , wherein the integrated septum comprises an angled distal face within an interior of the main branch.
16. 16 . The system of claim 14 , wherein the cannula is one of a sharp metal needle, a blunt metal needle, or a blunt plastic cannula.
17. 17 . The system of claim 14 , wherein the blood draw device further comprises a distal connector interface configured to removably couple the blood draw device to the near-patient access port member, and wherein the distal connector interface comprises a pair of connector clips.
18. 18 . A system for blood draw comprising: a catheter adapter comprising: a catheter configured to be inserted into a patient's vasculature, a proximal access port having an integrated septum positioned therein, and a side inlet, wherein both the proximal access port and the side inlet define a fluid pathway into and out of the catheter; a near-patient access port member having a main branch comprising a distal end portion couplable to the side inlet of the catheter adapter and a proximal end portion; and a blood draw device removably couplable to the proximal access port of the catheter adapter, wherein the blood draw device comprises: a cannula configured to penetrate the integrated septum of the catheter adapter; a flow tube configured to be advanced and retracted through the cannula; and a tube advancement tab coupled to the flow tube and configured to linearly advance and retract the flow tube through the cannula such that the flow tube is selectively directable through the blood draw device and the catheter adapter when the cannula of the blood draw device penetrates the integrated septum of the catheter adapter.
19. 19 . The system of claim 18 , wherein the cannula is a blunt cannula.
20. 20 . The system of claim 18 , wherein the blood draw device further comprises a distal connector interface configured to removably couple the blood draw device to the proximal access port of the catheter adapter.

Description

CROSS-REFERENCE TO RELATED APPLICATION The present application claims priority to U.S. Provisional Application Ser. No. 63/301,749, entitled “Vascular Access Device Blood Draw System with Septum Access” filed Jan. 21, 2022, the entire disclosure of which is hereby incorporated by reference in its entirety. BACKGROUND OF THE INVENTION Field of the Invention The present disclosure generally relates to vascular access devices (VAD), blood draw devices, and related assemblies, systems, and methods for use with, e.g., a peripheral intravenous catheter (PIVC). The VAD and blood draw devices are each configured for needle access via, e.g., a septum-type needle access port on the VAD. Description of Related Art A catheter is commonly used to infuse fluids into vasculature of a patient. For example, the catheter may be used for infusing normal saline solution, various medicaments, or total parenteral nutrition. Furthermore, the catheter may also be used for withdrawing blood from the patient. The catheter may be an over-the-needle peripheral intravenous catheter (PIVC). In this case, the catheter may be mounted over an introducer needle having a sharp distal tip. The catheter and the introducer needle may be assembled so that the distal tip of the introducer needle extends beyond the distal tip of the catheter with the bevel of the needle facing up away from skin of the patient. The catheter and introducer needle are generally inserted at a shallow angle through the skin into vasculature of the patient. After proper placement of the needle, the clinician may temporarily occlude flow in the vasculature and remove the needle, leaving the catheter in place (i.e., “indwelled”) for future blood withdrawal and/or fluid infusion. While PIVCs may be used for blood withdrawal, they are not typically designed and optimized for such purposes. Accordingly, several blood draw devices have been developed for use with PIVCs to improve blood collection. These devices (such as, e.g. PIVO™ from Velano Vascular Inc.) are configured as single-use devices which temporarily attach to a PIVC to draw a blood sample. Using an existing peripheral intravenous line as a conduit to the vasculature, the blood draw device advances a flexible, internal flow tube through the PIVC, beyond the catheter tip, and into the vein to collect a blood sample. This flow tube is designed to extend beyond any suboptimal draw conditions around the indwelling line to reach vein locations where blood flow is optimal for aspiration. Once blood collection is complete, the flow tube is retracted, and the device is removed from the PIVC and discarded. In order to accommodate such blood draw devices, PIVCs having an integrated extension set have been developed. These integrated vascular access devices (VADs) typically may include extension tubing that is integrated at one end into a catheter adapter, an access port (e.g., a luer connector) coupled to the other end, and a side port to facilitate blood draw. One such integrated VAD is disclosed in U.S. patent application Ser. No. 17/143,979, which is incorporated herein by reference in its entirety. To attach the blood draw device to the integrated VAD, a coupler mechanism such as, e.g., a male luer fitting or luer lock threaded collar is generally utilized, with the blood draw device having a blunt plastic cannula and/or luer distal connector to provide the coupling. However, in certain regions of the world, the use of such coupler mechanisms (e.g., luer connectors, etc.) is not common in medical settings. Instead, these regions typically utilize needle access-type connectors, pro re nata (PRN) connectors, etc., which may be incompatible with many modern blood draw devices. SUMMARY OF THE INVENTION Accordingly, the present disclosure generally relates to assemblies, systems, and methods including integrated VADs having a near-patient access port with a needle access septum and a tubing advancement-compatible fluid path, as well as blood draw devices having a distal access port connector compatible with a septum-type needle access port of the VAD. In accordance with an embodiment of the present disclosure, a system for blood draw is disclosed including a catheter adapter having a catheter configured to be inserted into a patient's vasculature and a side inlet defining a fluid pathway into and out of the catheter, and a near-patient access port member having a main branch including a distal end couplable to the side inlet of the catheter adapter and a proximal end having a needle access connector coupled thereto. The system also includes a blood draw device removably couplable to the near-patient access port member, wherein the blood draw device includes a cannula configured to penetrate the needle access connector of the near-patient access port member, a flow tube configured to be advanced and retracted through the cannula, and a tube advancement tab coupled to the flow tube and configured to linearly advance and retrac