Expandable shielded vessel support

• US 6,270,523 B1
• Filed: 10/15/1999
• Issued: 08/07/2001
• Est. Priority Date: 12/03/1996
• Status: Expired due to Term

• Current Assignee: Atrium Medical Corporation (Getinge AB)
• Original Assignee: Atrium Medical Corporation (Getinge AB)
• Inventors: Gingras, Peter, Martakos, Paul, Karwoski, Theodore, Herweck, Steve A.
• Primary Examiner(s): McDermott, Corrine
• Assistant Examiner(s): Koh, Choon P.
• Application Number:
  US09/419,467
• Time in Patent Office: 662 Days
• Field of Search: 623/1.13, 623/901, 606/194, 606/198, 606/191
• US Class Current: 623/1.13
• CPC Class Codes: A61F 2/06 Blood vessels
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2/105 Skin implants, e.g. artificial skin
• CPC Class Codes: A61F 2/88 the wire-like elements formed as helical or spiral coils forming a net-like or mesh-like structure A61F2/90
• CPC Class Codes: A61F 2002/072 Encapsulated stents, e.g. wire or whole stent embedded in lining
• CPC Class Codes: A61F 2240/001 Designing or manufacturing processes
• CPC Class Codes: A61L 31/04 Macromolecular materials
• CPC Class Codes: A61L 31/10 Macromolecular materials
• CPC Class Codes: C08L 27/18 Homopolymers or copolymers or tetrafluoroethene
• CPC Class Codes: Y10S 623/901 Method of manufacturing prosthetic device

Abstract

A radially expandable support body is enveloped within a cocoon. In a preferred construction, the support is a stent, and a tube of polymeric material, e.g., polytetraeluoroethylene (PTFE), passes through the interior of the stent body and is turned back upon itself over the stent to form a cuff. The assembly is then heated and the outer layer contacts and coalesces with the inner layer, closely surrounding the stent body within a folded envelope having a continuous and seamless end. In one embodiment, an end portion of the tube is expanded before folding back over the-stent. The end portion, which becomes an exterior surface of the finished product, thus acquires a greater degree of porosity. Each end of the central tube may be so expanded, and folded back to seal all surfaces and both ends. The stent body itself may be a ring, or a short series of spaced-apart rings, or a wire or web, or a sheet possessing a number of apertures extending entirely through the sheet. The spaces or apertures are covered over or bridged by both the inner and outer polymer layers. The apertures, which may comprise under five to over eighty percent of the surface area of the stent, constitute regions or a grid of points through which the material is coalesced and continuously bonded, and around which strain is distributed by the support. These points or regions remain tacked together so expansion of the assembly does not delaminate the polymer or create flaps and pockets. In another embodiment, a two tube construction is cuffed and assembled into a similarly unitized and seamless stent. One tube is cuffed back, and the other tube covers the cuffed stent. In this embodiment both the tube thicknesses and porosities may differ substantially. For example the inner porosity may be selected to enhance blood flow or intimal regeneration, and the outer surface may have a porosity to encourage anchoring to external muscle tissue.

Claims

1. A method of fabricating a stent, comprising the steps of;

positioning a tube formed of a polymer material within a stent body, the polymer tube having a first end and a second end;

folding the first end of the polymer tube over a first end of the stent body to form a first cuff enclosing the first end of the stent body;

folding the second end of the polymer tube over a second end of the stent body to form a second cuff enclosing the second end of the stent body and extending an amount at least sufficient to meet an end of said first cuff; and

coalescing the polymer tube to seal the first end of the stent body within the first cuff and the second end of the stent body within the second cuff such that said stent body is completely enclosed within a seamless cocoon of said polymer material.

2. The method of claim 1, wherein the step of coalescing includes the step of heating to contract and join the polymer tube to the stent body.

3. The method of claim 1, further comprising the step of increasing porosity of the first end of the polymer tube.

4. The method of claim 1, wherein the step of folding the first end includes the step of extending the first cuff to the middle of the polymer tube.

5. The method of claim 4, wherein the step of folding the second end includes the step of extending the second cuff to the middle of the polymer tube adjacent the first cuff to form a middle seam therebetween.

6. The method of claim 5, wherein the step of folding the second end includes the step of extending the second cuff over the first cuff.

7. The method of claim 1, wherein the polymer material is polytetrafluoroethylene (PTFE).

8. The method of claim 7, wherein the PTFE has a microstructure of nodes interconnected by fibrils.

9. The method of claim 1, further comprising the step of positioning a second tube over the stent.

10. The method of claim 9, wherein the first cuff encloses a first end of the second tube and the second cuff encloses a second end of the second tube.

11. The method of claim 9, wherein the second tube is positioned over the first cuff and over the second cuff.

12. The method of claim 9, further comprising the step of coalescing the second tube to the polymer tube.

13. The method of claim 9, wherein the second tube is formed of a fluoropolymer material.

14. The method of claim 9, wherein the second tube has a porosity different from the porosity of the polymer tube.

15. The method of claim 14, wherein the porosity of the second tube is greater than the porosity of the polymer tube.

16. The method of claim 9, wherein the second tube has a porosity suitable for promoting tissue ingrowth.

17. The method of claim 16, wherein the polymer tube has a porosity sufficient to inhibit tissue ingrowth.

18. The method of claim 1, further comprising

wrapping a layer of polymer material about the stent body.

19. The method of claim 18, wherein the first cuff encloses a first end of the layer and the second cuff encloses a second end of the layer.

20. The method of claim 18, further comprising coalescing the layer to the polymer tube.

21. A method of fabricating a stent, comprising the steps of;

positioning a tube formed of radially expandable polymer within a stent body, the polymer tube having a first end and a second end;

folding the first end of the polymer tube over a first end of the stent body to form a first cuff enclosing the first end of the stent body;

folding the second end of the polymer tube over a second end of the stent body and over the first cuff to form a second cuff enclosing the second end of the stent body; and

coalescing the polymer tube to seal the first end of the stent body within the first cuff and the second end of the stent body within the second cuff such that said stent body is completely enclosed within a seamless cocoon of said polymer material.

22. A stent comprising:

a radially expandable member; and

a polymer tube having first and second ends, a portion of the polymer tube being positioned within the radially expandable member, the first end of the polymer tube being folded over a first end of the radially expandable member to form a first cuff, the first end of the polymer tube being coalesced to the portion of the polymer tube within the radially expandable member to enclose the first end of the radially expandable member within the first cuff, the second end of the tube being folded over a second end of the radially expandable member extending an amount at least sufficient to meet an end of said first cuff to form a second cuff, the second end of the polymer tube being coalesced to the portion of the polymer tube within the radially expandable member to enclose the second end of the radially expandable member within the second cuff such that said stent body is completely enclosed within a seamless cocoon of said polymer material.

23. The stent of claim 22, wherein the first cuff extends to the middle of the polymer tube.

24. The stent of claim 23, wherein the second cuff extends to the middle of the polymer tube adjacent the first cuff to form a middle seam therebetween.

25. The stent of claim 22, wherein the polymer is a porous fluoropolymer material.

26. The stent of claim 25, wherein the fluoropolymer material is polytetrafluoroethylene (PTFE).

27. The stent of claim 26, wherein the PTFE has a microstructure of nodes interconnected by fibrils.

28. The stent of claim 22, wherein the polymer tube has a porosity sufficient to inhibit tissue ingrowth.

29. The stent of claim 22, further comprising a layer of polymer material positioned over at least a portion of the radially expandable member.

30. The stent of claim 29, wherein the first cuff encloses a first end of the layer and the second cuff encloses a second end of the layer.

31. The stent of claim 29, wherein the layer is positioned over the first cuff and over the second cuff.

32. The stent of claim 29, wherein the layer is joined to the portion of the polymer tube within the radially expandable member.

33. The stent of claim 29, wherein layer is formed of a fluoropolymer material.

34. The stent of claim 29, wherein the layer has a porosity different from the porosity of the portion of the polymer tube positioned within the radially expandable member.

35. The stent of claim 34, wherein the porosity of the layer is greater than the porosity of the portion of the polymer tube positioned within the radially expandable member.

36. The stent of claim 29, wherein the layer has a porosity suitable for promoting tissue ingrowth.

37. The stent of claim 36, wherein the polymer tube has a porosity sufficient to inhibit tissue ingrowth.

38. The stent of claim 29, wherein the layer comprises a tube of fluoropolymer material.

39. The stent of claim 29, wherein the layer comprise a wrap of fluoropolymer material.