Device and method for vascular access

• US 7,762,977 B2
• Filed: 08/31/2005
• Issued: 07/27/2010
• Est. Priority Date: 10/08/2003
• Status: Active Grant

• Current Assignee: Merit Medical Systems, Inc.
• Original Assignee: Hemosphere, Inc. (Cryolife Incorporated)
• Inventors: Porter, Christopher H., Doan, Tuan, Ziebol, Robert J., Lynch, Laurie E., Herrig, Judson A.
• Primary Examiner(s): Deak; Leslie R
• Application Number:
  US11/216,536
• Publication Number:
  US 20060064159A1
• Time in Patent Office: 1,791 Days
• Field of Search: 604/6.16, 604/8, 604/507, 604/508
• US Class Current: 604/6.16
• CPC Class Codes: A61B 17/00 Surgical instruments, devices or methods, e.g. tourniquets A61B18/00 takes precedence; contraceptive devices, pessaries, or applicators therefor A61F6/00; eye surgery A61F9/007; ear surgery A61F11/00
• CPC Class Codes: A61B 17/11 for performing anastomosis; Buttons for anastomosis
• CPC Class Codes: A61B 2017/1107 for blood vessels
• CPC Class Codes: A61B 2017/1132 End-to-end connections
• CPC Class Codes: A61B 2017/1135 End-to-side connections, e.g. T- or Y-connections Y-shaped blood vessel prostheses A61F2002/065
• CPC Class Codes: A61F 2/064 with special features to facilitate anastomotic coupling anastomosis of natural blood vessels A61B17/11
• CPC Class Codes: A61M 1/3653 Interfaces between patient blood circulation and extra-corporal blood circuit
• CPC Class Codes: A61M 1/3655 Arterio-venous shunts or fistulae
• CPC Class Codes: A61M 1/3659 Cannulae pertaining to extracorporeal circulation
• CPC Class Codes: A61M 1/3661 for haemodialysis
• CPC Class Codes: A61M 39/10 Tube connectors; Tube couplings A61M39/02 takes precedence; connecting needles to syringes or hubs A61M5/34; connecting catheter tubes to hubs A61M25/0014
• CPC Class Codes: A61M 60/113 in other functional devices, e.g. dialysers or heart-lung machines

Abstract

Vascular access systems for performing hemodialysis are disclosed. The vascular access system contemplates a catheter section adapted for insertion into a vein and a graft section adapted for attachment to an artery. The catheter section may have metal or polymer wall reinforcements that allow the use of thin-walled, small outer diameter conduits for the vascular access system. One or more of the adhered, embedded or bonded conduit reinforcement structures may be removable without significant damage to the conduit sections to facilitate attachment of the sections, or to a connector between the sections. Various self-sealing materials are provided for use in the vascular access system, as well as temporary access sites and flow control/sensor systems.

Claims

1. A method for treating a patient, comprising:

providing a first and second conduit of a vascular access system;

accessing a vein at a first access site;

inserting the first conduit of the vascular access system into the vein;

forming a subcutaneous pathway between the first access site and an intermediate access site;

accessing an artery at a second access site;

attaching the second conduit to an artery through the second access site; and

positioning the first conduit and second conduit of the vascular access system in the subcutaneous pathway;

accessing an end of the first conduit and an end of the second conduit through the intermediate access site;

connecting the end of the first conduit and the end of the second conduit and reinserting the connected ends of the first conduit and the second conduit through the intermediate access site.

2. The method for treating a patient as in claim 1, further comprising providing a connector and connecting the first conduit and second conduit of the vascular access system via the connector.

3. The method for treating a patient as in claim 1, wherein positioning the first conduit and second conduit in the subcutaneous pathway comprises passing an end of the first conduit from the first access site to the intermediate access site and passing an end of the second conduit from the second access site to the intermediate access site.

4. The method for treating a patient as in claim 1, wherein positioning the first conduit and second conduit in the subcutaneous pathway comprises passing an end of the first conduit from the intermediate access site to the first access site and passing an end of the second conduit from the intermediate access site to the second access site.

5. The method for treating a patient as in claim 1, wherein positioning the first conduit and second conduit in the subcutaneous pathway comprises passing an end of the first conduit from the first access site to the intermediate access site and passing an end of the second conduit from the intermediate access site to the second access site.

6. The method for treating a patient as in claim 1, wherein positioning the first conduit and second conduit in the subcutaneous pathway comprises passing an end of the first conduit from the intermediate access site to the first access site and passing an end of the second conduit from the second access site to the intermediate access site.

7. A method for treating a patient, comprising:

providing a blood pathway having a first section and a second section, the blood pathway for conveying blood between a vein and an artery;

accessing a vein at a first access site;

inserting an end portion of the first section of the blood pathway into the vein;

forming a subcutaneous pathway between the first access site and a second access site;

attaching an end portion of the second section of the blood pathway at the second access site; and

coupling the first section with the second section through an incision formed at a third access site disposed between the first and second access sites.

8. The method for treating a patient as in claim 7, further comprising closing each of the access sites such that the blood pathway is entirely subcutaneous.

9. The method for treating a patient as in claim 7, wherein coupling comprises positioning a connector between the first and second sections, wherein smooth transitions are provided at least at the junction between the first section and the connector and between the second section and the connector.

10. The method for treating a patient as in claim 9, wherein a smooth transition is provided along a change in circumference within the connector between the first and second sections.

11. The method for treating a patient as in claim 7, wherein coupling comprises positioning a connector between the first and second sections, wherein an internal lumen within the connector comprises a change in circumference within no more than one inflection point as seen in a longitudinal cross-section of the connector.

12. The method for treating a patient as in claim 7, further comprising providing a connector and inserting at least one of the first and second ends of the connector into lumens extending from ends of the first and second sections.

13. The method for treating a patient as in claim 12, further comprising causing a circumferential force to be applied through at least a portion of at least one of the first and second sections toward at least one of the first and second ends of the connector.

14. The method for treating a patient as in claim 12, further comprising advancing ends of at least one of the first and second sections over circumferential protrusions disposed on an outside surface of at least one of the first and second ends of the connector.

15. The method for treating a patient as in claim 14, wherein the protrusion comprises one or more barbs.

16. The method for treating a patient as in claim 15, wherein the circumferential compressive force is applied by applying a crimp ring to the outside of at least one of the first and second sections.

17. The method for treating a patient as in claim 12, further comprising causing a circumferential force to be applied through at least a portion of each of the first and second sections toward a corresponding one of the first and second ends of the connector.

18. The method for treating a patient as in claim 12, wherein the connector is pre-attached to the second section of the blood pathway.

19. The method for treating a patient as in claim 7, wherein the artery is a brachial artery.

20. The method for treating a patient as in claim 7, wherein the vein is a jugular vein.

21. The method for treating a patient as in claim 20, wherein the artery is a brachial artery.

22. The method for treating a patient as in claim 21, wherein the third access site is adjacent to the delto-pectoral groove.

23. The method for treating a patient as in claim 7, wherein the subcutaneous pathway is formed to minimize kinking of the blood pathway.

24. The method for treating a patient as in claim 23, wherein the subcutaneous pathway is formed to exceed a minimum bend radius to minimize kinking.

25. The method for treating a patient as in claim 7, wherein the blood pathway comprises a self-sealing area.

26. The method for treating a patient as in claim 25, wherein the self-sealing area comprises a self-sealing material.

27. The method for treating a patient as in claim 25, wherein the self-sealing area comprises a self-sealing layer.

28. The method for treating a patient as in claim 25, wherein the self-sealing area comprises an area of residual compressive stress.

29. The method for treating a patient as in claim 25, wherein the self-sealing area is elongate and flexible along its length to facilitate implantation.

30. The method for treating a patient as in claim 7, wherein the blood pathway comprises a needle access site comprising a self-sealing material or structure and further comprising positioning the needle access site subcutaneously.