DEVICE AND METHOD FOR VASCULAR ACCESS

• US 20110060264A1
• Filed: 07/06/2010
• Published: 03/10/2011
• Est. Priority Date: 10/08/2003
• Status: Active Grant

• Current Assignee: Merit Medical Systems, Inc.
• Original Assignee: Hemosphere, Inc. (Cryolife Incorporated)
• Inventors: Ziebol, Robert J., Lynch, Laurie E., Herrig, Judson A., Porter, Christopher H.
• Granted Patent: US 8,690,815 B2
• Time in Patent Office: Days
• US Class Current: 604/8
• 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
• 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. An apparatus for providing needle access to a blood pathway comprising:

a graft conduit for attachment to an artery;

a catheter conduit for insertion in a vein; and

a self-sealing element, comprising;

a wall structure defining, at least in part, an internal passageway in fluid communication with said graft and catheter conduits so that, in use, said conduits and said passageway can form said blood pathway;

said wall structure being formed of a tubular material that can be punctured by a needle to permit needle access to said passageway and re-seals upon withdrawal of said needle,

wherein said self-sealing element is formed a wall of the catheter conduit or located between the graft conduit and catheter conduit.

2. The apparatus for providing needle access to a blood pathway as in claim 1, wherein said material being selected from the group consisting of:

material subject to compressive stress;

material having a porous structure enhancing microthrombosis;

low durometer materials, thixotropic materials and/or a gelatinous material.

3. The apparatus for providing needle access to a blood pathway as in claim 1, wherein said material comprises material subject to compressive stress.

4. The apparatus for providing needle access to a blood pathway as in claim 3, wherein said material comprises at least two layers subject to compressive stress of different orientations.

5. The apparatus for providing needle access to a blood pathway as in claim 1, wherein said material comprises material having a porous structure.

6. The apparatus for providing needle access to a blood pathway as in claim 1, wherein said material comprises gelatinous material.

7. The apparatus for providing needle access to a blood pathway as in claim 1, further comprising a conduit connector, wherein said conduit connector is adapted to join the graft conduit and the catheter conduit.

8. The apparatus for providing needle access to a blood pathway as in claim 7, wherein said conduit connector is pre-connected to the graft conduit at the point of manufacture or integral with the graft conduit.

9. The apparatus for providing needle access to a blood pathway as in claim 1, further comprising a strain relief tube about the catheter conduit, said strain relief tube having a first end and a second end, the second end comprising two or more flexural sections and two or more separations between the flexural sections.

10. The apparatus for providing needle access to a blood pathway as in claim 1, further comprising a means for controlling blood flow rate through the blood pathway.

11. The apparatus for providing needle access to a blood pathway as in claim 1, further comprising a means for monitoring blood flow rate through the blood pathway.

12. 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;

accessing an artery at a second access site;

forming a subcutaneous pathway between the first access site and the 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.

13. The method for treating a patient as in claim 12, further comprising connecting the first conduit and second conduit of the vascular access system.

14. The method for treating a patient as in claim 12, 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.

15. The method for treating a patient as in claim 14, further comprising connecting the end of the first conduit and the end of the second conduit and inserting the connected ends of the first conduit and second conduit back through the intermediate access site.

16. The method for treating a patient as in claim 12, 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.

17. The method for treating a patient as in claim 12, 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.

18. A method for inserting a catheter, comprising:

providing a catheter insert comprising an insert shaft with a guidewire lumen, and a collapsible distal tapered tip having an expanded configuration and a reduced configuration;

providing a catheter having a first end a second end, and a lumen therebetween;

inserting the catheter insert into the lumen of the catheter;

expanding the collapsible distal tapered tip to its expanded configuration;

passing the distal tapered tip of the catheter insert into a vein;

positioning the catheter and catheter insert into the vein; and

collapsing the collapsible distal tapered tip to its reduced configuration.

19. The method for inserting a catheter as in claim 18, further comprising sealing the second end of the catheter with the collapsible distal tapered tip in the expanded configuration.

20. The method for inserting a catheter as in claim 18, further comprising removing the catheter insert from the catheter lumen.