Intraluminal stent graft

• US 5,810,870 A
• Filed: 06/07/1995
• Issued: 09/22/1998
• 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): Buiz, Michael Powell
• Assistant Examiner(s): MULCARE, NANCY C
• Application Number:
  US08/479,931
• Time in Patent Office: 1,203 Days
• Field of Search: 606/191, 606/195, 606/198, 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 tubular covering of porous expanded polytetrafluoroethylene affixed to the exterior surface of the tubular diametrically adjustable stent, said tubular covering being less than about 0.10 mm thick, and said tubular cover having an exterior surface, a luminal surface and a seam extending from the exterior surface through to the luminal surface of the tubular covering.

2. A tubular intraluminal graft according to claim 1 wherein the tubular covering of porous expanded polytetrafluoroethylene is affixed to the exterior surface of the tubular diametrically adjustable stent by an adhesive.

3. A tubular intraluminal graft according to claim 2 wherein the adhesive is a thermoplastic adhesive.

4. A tubular intraluminal graft according to claim 3 wherein the thermoplastic adhesive is a thermoplastic fluoropolymer adhesive.

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

6. A tubular intraluminal graft according to claim 1 wherein the porous expanded polytetrafluoroethylene has a microstructure of nodes interconnected by uniaxially-oriented fibrils which are substantially parallel to each other, said uniaxially-oriented fibrils being oriented circumferentially with respect to the tubular, diametrically adjustable stent.

7. A tubular intraluminal graft according to claim 1 wherein the porous expanded polytetrafluoroethylene has a microstructure of nodes interconnected by uniaxially-oriented fibrils which are substantially parallel to each other, said uniaxially-oriented fibrils being oriented lengthwise with respect to the tubular, diametrically adjustable stent.

8. A tubular intraluminal graft according to claim 1 wherein the porous expanded polytetrafluoroethylene has a microstructure of nodes interconnected by fibrils which are oriented in two substantially perpendicular directions, said two substantially perpendicular directions being oriented circumferentially and 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 tubular covering to the exterior surface of the tubular, diametrically adjustable stent, said covering being less than 0.10 mm thick 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.

13. A method according to claim 12 wherein the tubular covering is affixed with an adhesive.

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

15. 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, said tubular, diametrically adjustable stent having a collapsed diameter and an enlarged diameter wherein said enlarged diameter is at least 1.5 times the collapsed diameter, wherein said tubular, diametrically adjustable stent has been diametrically adjusted to the enlarged diameter;

b) affixing a tubular covering to the tubular, diametrically adjustable stent; and

c) collapsing the tubular, diametrically adjustable stent to about the collapsed diameter

wherein the tubular covering is affixed to the exterior surface of the tubular, diametrically adjustable stent.

16. A method according to claim 15 wherein said tubular covering is less than about 0.10 mm thick.

17. A method according to claim 16 wherein said tubular covering is of porous expanded PTFE.

18. A method according to claim 17 wherein said tubular covering has an exterior surface, a luminal surface and a seam extending from the exterior surface through to the luminal surface of the tubular covering.

19. A method according to claim 16 wherein said tubular covering has an exterior surface, a luminal surface and a seam extending from the exterior surface through to the luminal surface of the tubular covering.

20. A method according to claim 15 wherein said tubular covering is of porous expanded PTFE.

21. A method according to claim 20 wherein said tubular covering has an exterior surface, a luminal surface and a seam extending from the exterior surface through to the luminal surface of the tubular covering.