Intraluminal stent graft

• US 5,735,892 A
• Filed: 08/18/1993
• Issued: 04/07/1998
• Est. Priority Date: 08/18/1993
• Status: Expired due to Term

• Current Assignee: W. L. Gore & Associates (W.L. Gore & Associates)
• Original Assignee: W. L. Gore & Associates (W.L. Gore & Associates)
• Inventors: House, Wayne D., Myers, David J., Lewis, James D., Schwarz, Karl E.
• Primary Examiner(s): Jackson, Gary
• Assistant Examiner(s): MULCARE, NANCY C
• Application Number:
  US08/109,214
• Time in Patent Office: 1,693 Days
• Field of Search: 606/198, 606/191, 606/195, 623/1, 623/12
• US Class Current: 623/1.13
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2/82 Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents stent-grafts for tubular structures of the body other than blood vessels A61F2/04; stent-grafts for blood vessels A61F2/07; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95; for closing wounds, or holding wounds closed A61B17/04 - A61B17/115; dilators A61M29/00
• CPC Class Codes: A61F 2/90 characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2002/072 Encapsulated stents, e.g. wire or whole stent embedded in lining
• CPC Class Codes: A61F 2002/075 the stent being loosely attached to the graft material, e.g. by stitching
• CPC Class Codes: A61F 2210/0014 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2240/001 Designing or manufacturing processes
• CPC Class Codes: A61L 31/10 Macromolecular materials
• CPC Class Codes: C08L 27/18 Homopolymers or copolymers or tetrafluoroethene
• CPC Class Codes: Y10T 156/1005 by inward collapsing of portion of hollow body
• CPC Class Codes: Y10T 156/1033 Flexible sheet to cylinder lamina
• CPC Class Codes: Y10T 29/4998 Combined manufacture including applying or shaping of fluent material
• CPC Class Codes: Y10T 29/49982 Coating

Abstract

A tubular intraluminal graft in the form of a tubular diametrically adjustable stent having a tubular covering of porous expanded polytetrafluoroethylene which is less than 0.10 mm thick. The covering may be on the exterior surface of the stent, or on the interior surface of the stent, or both. The covering may be affixed to the stent by an adhesive which is preferably fluorinated ethylene propylene.

Claims

1. A tubular intraluminal graft comprising:

a) a tubular, diametrically adjustable stent having an exterior surface, a luminal surface and a wall, and having a multiplicity of openings through the wall of the stent;

b) a first tubular covering of porous expanded polytetrafluoroethylene affixed to the exterior surface of the tubular, diametrically adjustable stent and having an exterior surface, a luminal surface and a seam extending from the exterior surface through to the luminal surface; and

c) a second tubular covering of porous expanded polytetrafluoroethylene affixed to the luminal surface of the tubular, diametrically adjustable stent, and having an exterior surface, a luminal surface and a seam extending from the exterior surface through to the luminal surface;

wherein the combined thickness of the first and second tubular coverings is less than about 0.10 mm,thick exclusive of the stent.

2. A tubular intraluminal graft according to claim 1 wherein the first tubular covering of porous expanded polytetrafluoroethylene is affixed to the second tubular covering of porous expanded polytetrafluoroethylene film through openings through the wall of the stent.

3. A tubular intraluminal graft according to claim 2 wherein the first tubular covering of porous expanded polytetrafluoroethylene is affixed to the second tubular covering of porous expanded polytetrafluoroethylene film by an adhesive.

4. A tubular intraluminal graft according to claim 3 wherein the adhesive is fluorinated ethylene propylene.

5. A tubular intraluminal graft according to claim 1 wherein the first and second tubular coverings of porous expanded polytetrafluoroethylene are affixed by an adhesive.

6. A tubular intraluminal graft according to claim 5 wherein the adhesive is fluorinated ethylene propylene.

7. A tubular intraluminal graft according to claim 1 wherein the first tubular covering of porous expanded polytetrafluoroethylene has a microstructure of nodes interconnected by uniaxially-oriented fibrils which are oriented circumferentially with respect to the tubular, diametrically adjustable stent, and wherein the second tubular covering of porous expanded polytetrafluoroethylene has a microstructure of nodes interconnected by uniaxially-oriented fibrils which are oriented longitudinally with respect to the tubular, diametrically adjustable stent.

8. A tubular intraluminal graft according to claim 2 wherein the first tubular covering of porous expanded polytetrafluoroethylene has a microstructure of nodes interconnected by uniaxially-oriented fibrils which are oriented circumferentially with respect to the tubular, diametrically adjustable stent, and wherein the second tubular covering of porous expanded polytetrafluoroethylene has a microstructure of nodes interconnected by uniaxially-oriented fibrils which are oriented longitudinally with respect to the tubular, diametrically adjustable stent.

9. A tubular intraluminal graft according to claim 1 wherein the tubular diametrically adjustable stent is a Nitinol stent.

10. A tubular intraluminal graft according to claim 1 wherein the stent is a balloon-expandable stent.

11. A tubular intraluminal graft according to claim 1 wherein the stent is a self-expanding stent of braided wire.

12. A method of making a tubular intraluminal graft comprising:

a) selecting at least one tubular, diametrically adjustable stent having an exterior surface, a luminal surface and a wall, and having a multiplicity of openings through the wall of the stent;

b) affixing a first tubular covering to the exterior surface and a second tubular covering to the luminal surface, said first and second tubular coverings being in combination less than about 0.10 mm thick and said first and second tubular coverings having an exterior surface, a luminal surface and a seam extending from the exterior surface through to the luminal surface of the tubular covering.

13. A method according to claim 12 wherein the first and second tubular coverings are affixed by an adhesive.

14. A method according to claim 13 wherein the adhesive is fluorinated ethylene propylene.

15. A tubular intraluminal graft comprising:

a) a tubular, diametrically adjustable stent having an exterior surface, a luminal surface, an end edge and a wall, and having a multiplicity of openings through the wall of the stent;

b) a tubular covering of porous expanded polytetrafluoroethylene affixed to the tubular, diametrically adjustable stent;

wherein the tubular covering of porous expanded polytetrafluoroethylene is folded over the end edge of the tubular, diametrically adjustable stent and is affixed to the exterior surface and the luminal surface of the tubular diametrically adjustable stent, and wherein the folded tubular covering has a thickness less than about 0.10 mm thick exclusive of the stent.

16. A tubular intraluminal graft according to claim 15 wherein the tubular covering is affixed by an adhesive.

17. A tubular intraluminal graft according to claim 15 wherein the tubular covering is affixed with sutures.

18. A tubular intraluminal graft comprising:

a) a tubular, diametrically adjustable stent having an exterior surface, a luminal surface and a wall, and having a multiplicity of openings through the wall of the stent;

b) a first tubular covering of porous expanded polytetrafluoroethylene affixed to the exterior surface of the tubular, diametrically adjustable stent, and having an exterior surface, a luminal surface and a seam extending from the exterior surface through to the luminal surface; and

c) a second tubular covering of porous expanded polytetrafluoroethylene affixed to the luminal surface of the tubular, diametrically adjustable stent, and having an exterior surface, a luminal surface and a seam extending from the exterior surface through to the luminal surface.

19. A tubular intraluminal graft according to claim 18 wherein the first tubular covering of porous expanded polytetrafluoroethylene is affixed to the second tubular covering of porous expanded polytetrafluoroethylene film through openings through the wall of the stent.

20. A tubular intraluminal graft according to claim 19 wherein the first tubular covering of porous expanded polytetrafluoroethylene has a microstructure of nodes interconnected by uniaxially-oriented fibrils which are oriented circumferentially with respect to the tubular, diametrically adjustable stent, and wherein the second tubular covering of porous expanded polytetrafluoroethylene has a microstructure of nodes interconnected by uniaxially-oriented fibrils which are oriented longitudinally with respect to the tubular, diametrically adjustable stent.

21. A tubular intraluminal graft according to claim 19 wherein the first tubular covering of porous expanded polytetrafluoroethylene is affixed to the second tubular covering of porous expanded polytetrafluoroethylene film by an adhesive.

22. A tubular intraluminal graft according to claim 21 wherein the adhesive is fluorinated ethylene propylene.

23. A tubular intraluminal graft according to claim 18 wherein the first and second tubular coverings of porous expanded polytetrafluoroethylene are affixed by an adhesive.

24. A tubular intraluminal graft according to claim 23 wherein the adhesive is fluorinated ethylene propylene.

25. A tubular intraluminal graft according to claim 18 wherein the first tubular covering of porous expanded polytetrafluoroethylene has a microstructure of nodes interconnected by uniaxially-oriented fibrils which are oriented circumferentially with respect to the tubular, diametrically adjustable stent, and wherein the second tubular covering of porous expanded polytetrafluoroethylene has a microstructure of nodes interconnected by uniaxially-oriented fibrils which are oriented longitudinally with respect to the tubular, diametrically adjustable stent.

26. A tubular intraluminal graft according to claim 18 wherein the tubular diametrically adjustable stent is a Nitinol stent.

27. A tubular intraluminal graft according to claim 18 wherein the stent is a balloon-expandable stent.

28. A tubular intraluminal graft according to claim 18 wherein the stent is a self-expanding stent of braided wire.

29. A tubular intraluminal graft comprising:

a) a tubular, diametrically adjustable stent having an exterior surface, a luminal surface, an end edge and a wall, and having a multiplicity of openings through the wall of the stent;

b) a tubular covering of porous expanded polytetrafluoroethylene affixed to the tubular, diametrically adjustable stent, and said tubular covering having an exterior surface, a luminal surface and a seam extending from the exterior surface through to the luminal surface of the tubular covering;

wherein the tubular covering of porous expanded polytetrafluoroethylene is folded over the end edge of the tubular, diametrically adjustable stent and is affixed to the exterior surface and the luminal surface of the tubular diametrically adjustable stent.

30. A tubular intraluminal graft according to claim 29 wherein the tubular covering is affixed by an adhesive.

31. A tubular intraluminal graft according to claim 29 wherein the tubular covering is affixed with sutures.

32. A tubular intraluminal graft comprising:

a) a tubular, diametrically adjustable stent having an exterior surface, a luminal surface and a wall, and having a multiplicity of openings through the wall of the stent;

b) a first tubular covering of porous expanded polytetrafluoroethylene affixed to the exterior surface of the tubular, diametrically adjustable stent; and

c) a second tubular covering of porous expanded polytetrafluoroethylene affixed to the luminal surface of the tubular, diametrically adjustable stent;

wherein the combined thickness of the first and second tubular coverings is less than about 0.10 mm thick exclusive of the stent.

33. A tubular intraluminal graft according to claim 32 wherein the first tubular covering of porous expanded polytetrafluoroethylene is affixed to the second tubular covering of porous expanded polytetrafluoroethylene film through openings through the wall of the stent.

34. A tubular intraluminal graft according to claim 33 wherein the first tubular covering of porous expanded polytetrafluoroethylene is affixed to the second tubular covering of porous expanded polytetrafluoroethylene film by an adhesive.

35. A tubular intraluminal graft according to claim 34 wherein the adhesive is fluorinated ethylene propylene.

36. A tubular intraluminal graft according to claim 32 wherein the first and second tubular coverings of porous expanded polytetrafluoroethylene are affixed by an adhesive.

37. A tubular intraluminal graft according to claim 36 wherein the adhesive is fluorinated ethylene propylene.

38. A tubular intraluminal graft according to claim 32 wherein the first tubular covering of porous expanded polytetrafluoroethylene has a microstructure of nodes interconnected by uniaxially-oriented fibrils which are oriented circumferentially with respect to the tubular, diametrically adjustable stent, and wherein the second tubular covering of porous expanded polytetrafluoroethylene has a microstructure of nodes interconnected by uniaxially-oriented fibrils which are oriented longitudinally with respect to the tubular, diametrically adjustable stent.

39. A tubular intraluminal graft according to claim 33 wherein the first tubular covering of porous expanded polytetrafluoroethylene has a microstructure of nodes interconnected by uniaxially-oriented fibrils which are oriented circumferentially with respect to the tubular, diametrically adjustable stent, and wherein the second tubular covering of porous expanded polytetrafluoroethylene has a microstructure of nodes interconnected by uniaxially-oriented fibrils which are oriented longitudinally with respect to the tubular, diametrically adjustable stent.

40. A tubular intraluminal graft according to claim 32 wherein the tubular diametrically adjustable stent is a Nitinol stent.

41. A tubular intraluminal graft according to claim 32 wherein the stent is a balloon-expandable stent.

42. A tubular intraluminal graft according to claim 32 wherein the stent is a self-expanding stent of braided wire.

43. A method of making a tubular intraluminal graft comprising:

a) selecting at least one tubular, diametrically adjustable stent having an exterior surface, a luminal surface and a wall, and having a multiplicity of openings through the wall of the stent;

b) affixing a first tubular covering to the exterior surface and a second tubular covering to the luminal surface, said first and second tubular coverings being in combination less than about 0.10 mm thick.

44. A method according to claim 43 wherein the first and second tubular coverings are affixed by an adhesive.

45. A method according to claim 44 wherein the adhesive is fluorinated ethylene propylene.

46. A method of making a tubular intraluminal graft comprising:

a) selecting at least one tubular, diametrically adjustable stent having an exterior surface, a luminal surface and a wall, and having a multiplicity of openings through the wall of the stent;

b) affixing a first tubular covering to the exterior surface and a second tubular covering to the luminal surface, and said first and second tubular coverings having an exterior surface, a luminal surface and a seam extending from the exterior surface through to the luminal surface of the tubular covering.

47. A method according to claim 46 wherein the first and second tubular coverings are affixed by an adhesive.

48. A method according to claim 47 wherein the adhesive is fluorinated ethylene propylene.