Prosthetic vascular graft

• US 5,716,395 A
• Filed: 08/27/1996
• Issued: 02/10/1998
• Est. Priority Date: 12/11/1992
• Status: Expired due to Term

• Current Assignee: W. L. Gore & Associates (W.L. Gore & Associates)
• Original Assignee: WL Gore and Associates Incorporated (W.L. Gore and Associates)
• Inventors: Myers, David J., Lewis, James D.
• Primary Examiner(s): BRITTINGHAM, DEBRA
• Application Number:
  US08/705,912
• Time in Patent Office: 532 Days
• Field of Search: 623/1, 623/11, 623/12, 600/36, 606/191-200
• US Class Current: 623/1.5
• CPC Class Codes: A61F 2/06 Blood vessels
• CPC Class Codes: A61L 27/507 for artificial blood vessels apparatus for applying cells on a blood vessel prosthesis A61F2/062

Abstract

A vascular graft in the form of a tube or flat sheet of biocompatible material having an outer covering of deflectably secured material such as porous film, fibers, discrete pieces of material, or combinations thereof. The vascular graft may be of tubular form for replacing or bypassing entire segments of veins or arteries or alternatively may be in the form of a flat sheet useful for repairing portions of the circumference of veins or arteries. The tube or flat sheet of biocompatible material and the outer covering of deflectably secured material are preferably of porous polytetrafluoroethylene. The inventive vascular graft is useful for dialysis access in that it offers a reduction in blood leakage when the vascular graft is punctured by a dialysis needle and the needle is subsequently removed. It is also useful for reducing suture hole bleeding resulting from holes created through the graft by penetration of the graft with a suture needle.

Claims

1. A vascular graft comprising:

a) a biocompatible base substrate having a lumenal and ablumenal surface; and

b) a biocompatible material covering a substantial portion of the ablumenal surface of said substrate, said biocompatible material being secured to said ablumenal surface at at least one point and being deflectable with respect to said ablumenal surface,

wherein said biocompatible material comprises at least one fiber having a surface, wherein said at least one fiber is arranged such that various portions of the surface may be adjacent to each other, and wherein a substantial portion of said various adjacent surface portions are free to move with respect to each other.

2. The vascular graft of claim 1 in which said material covering said ablumenal surface comprises at least two fibers.

3. The vascular graft of claim 1 wherein said at least one fiber comprises a non-elastomeric fiber.

4. The vascular graft of claim 1 wherein said at least one fiber comprises a biocompatible material selected from the group consisting of polytetrafluoroethylene, polyethylene terephthalate and biologic material.

5. The vascular graft of claim 4 wherein said at least one fiber comprises porous polytetrafluoroethylene.

6. The vascular graft of claim 1 in which said base substrate is in the form of a tube.

7. The vascular graft of claim 6 wherein the at least one fiber is oriented parallel to the base substrate.

8. The vascular graft of claim 6 wherein said tube has a longitudinal axis and wherein said at least one fiber is oriented substantially perpendicular to the longitudinal axis.

9. The vascular graft of claim 8 wherein said at least one fiber is comprised of porous polytetrafluoroethylene.

10. The vascular graft of claim 6 wherein said tube has a longitudinal axis and wherein said at least one fiber is oriented substantially parallel to the longitudinal axis.

11. The vascular graft of claim 10 wherein said at least one fiber is comprised of porous polytetrafluoroethylene.

12. The vascular graft of claim 1 in which said material is secured to said ablumenal surface at at least one point by adhesive means.

13. The vascular graft of claim 12 in which said adhesive means comprises an adhesive selected from the group consisting of silicone, fluorinated ethylene propylene and perfluoroalkoxy.

14. The vascular graft of claim 1 wherein the at least one fiber is oriented parallel to the base substrate.

15. The vascular graft of claim 14 wherein the at least one fiber comprises a plurality of fibers oriented substantially parallel to each other.

16. The vascular graft of claim 1 wherein the at least one fiber is arranged in a construction selected from the group consisting of weaves, knits, braids and mats.

17. The vascular graft of claim 1 in which said material is secured to said ablumenal surface at at least one point by adhesive means.

18. The vascular graft of claim 17 in which said adhesive means comprises an adhesive selected from the group consisting of silicone, fluorinated ethylene propylene and perfluoroalkoxy.

19. The vascular graft of claim 1 wherein said biocompatible base substrate is selected from the group of biocompatible base substrates consisting of polytetrafluoroethylene, polyethylene terephthalate and biologic materials.

20. The vascular graft of claim 19 wherein said biocompatible base substrate comprises porous polytetrafluoroethylene.

21. The vascular graft of claim 20 wherein said biocompatible base substrate comprises a porous polytetrafluoroethylene tube.

22. The vascular graft of claim 21 wherein said porous polytetrafluoroethylene tube at ambient temperature is capable of being stretched and rapidly recovering more than about 10 percent of its stretched length.

23. The vascular graft of claim 19 wherein said biocompatible material is selected from the group of biocompatible materials consisting of polytetrafluoroethylene, polyethylene terephthalate and biologic materials.

24. The vascular graft of claim 23 wherein said biocompatible material comprises porous polytetrafluoroethylene.

25. The vascular graft of claim 1 wherein said biocompatible material is selected from the group of biocompatible materials consisting of polytetrafluoroethylene, polyethylene terephthalate and biologic materials.

26. The vascular graft of claim 25 wherein said biocompatible material comprises porous polytetrafluoroethylene.