Expandable shielded vessel support

• US 6,010,529 A
• Filed: 12/03/1996
• Issued: 01/04/2000
• 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): Yu, Mickey
• Assistant Examiner(s): Koh, Choon P.
• Application Number:
  US08/759,877
• Time in Patent Office: 1,127 Days
• Field of Search: 623/1, 623/11, 623/12, 606/192, 606/194, 606/195, 606/198, 600/36
• US Class Current: 623/23.69
• 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. polytetrafluoroethylene (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 radially expandable polymer centrally in a stent body,

radially expanding a first portion of the tube,

folding back the radially expanded first portion of the tube over a second portion of the tube so the tube extends inside and outside the stent body and forms a cuff seamlessly and continuously enclosing at least one end of the stent body within a cocoon, and

coalescing the tube to seal the stent body within the cocoon.

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

3. The method of claim 1, including the step of increasing porosity of the radially expanded first portion of the tube.

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

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

folding the first end of the tube over a first end of the stent body to form a first cuff enclosing the first end of the stent body within a cocoon,

folding the second end of the tube over a second end of the stent body to form a second cuff enclosing the second end of the stent body within a cocoon, and

coalescing the 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.

5. The method of claim 4, wherein the step of coalescing includes the step of heating to contract and join the tube to the stent body.

6. The method of claim 4, further comprising the step of increasing porosity of the first end of the tube.

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

8. The method of claim 7, wherein the step of folding the second end includes the step of extending the second cuff to the middle of the tube adjacent the first cuff to form a middle seam therebetween.

9. The method of claim 7, wherein the step of folding the second end includes the step of extending the second cuff over the first cuff.

10. 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 second end of the polymer tube being folded over a second end of the radially expandable member to form a second cuff, wherein the second cuff overlaps the first cuff.

11. The stent of claim 10, wherein the first end of the polymer tube has a porosity greater than the porosity of the portion of the polymer tube positioned within the radially expandable member.

12. The stent of claim 10, wherein the first and second ends of the polymer tube have a porosity greater than the porosity of the portion of the polymer tube positioned within the radially expandable member.

13. The stent of claim 10, wherein the polymeric tube is constructed from polytetrafluoroethylene (PTFE).

14. The stent of claim 10, wherein the radially expandable member comprises a spiral-shaped, zig-zag wire body.

15. The stent of claim 10, wherein the radially expandable member comprises a plurality of spaced-apart expansion rings.

16. An expandable vessel support comprising:

a tube of polymeric material having first and second ends,

a first expansion ring positioned at the first end of the tube,

a second expansion ring position at the second end of the tube, and

a third expansion ring positioned between the first and second ends, the third expansion ring being expandable to a greater diameter than the first and second expansion rings.

17. The expandable vessel support of claim 16, wherein the first and second expansion rings are constructed from a heavier gauge material than the third expansion ring.

18. The expandable vessel support of claim 16, wherein the expansion rings are positioned within pockets formed in the tube of polymeric material.

19. The expandable vessel support of claim 16, wherein the polymeric material is PTFE.

20. An expandable vessel support comprising:

a tube of polymeric material having first and second ends,

a first expansion ring positioned at the first end of the tube,

a second expansion ring position at the second end of the tube, and

a third expansion ring positioned between the first and second ends, the first and second expansion rings being expandable to a greater diameter than the third expansion ring.

21. The vessel support of claim 20, wherein the third expansion ring is constructed from a heavier gauge material than the first and second expansion rings.

22. The vessel support of claim 20, wherein the expansion rings are positioned within pockets formed in the tube of polymeric material.

23. The vessel support of claim 20, wherein the polymeric material is PTFE.

24. An expandable vessel support comprising:

a tube of polymeric material having a first end and a second end, the first and second ends being constructed to have greater radial tensile strength than a portion of the tube between the first and second ends to permit increased expansion of the portion of the tube between the first and second ends, the tube having a radially tapered configuration when expanded.

25. The vessel support of claim 24, wherein the polymeric material is PTFE.

27. The vessel support of claim 24, wherein the polymeric material is PTFE.

26. An expandable vessel support comprising:

a tube of polymeric material having a first end and a second end, the first and second ends being constructed to have less radial tensile strength than a portion of the tube between the first and second ends to permit increased expansion of the first and second ends, the tube having a radially tapered configuration when expanded.

28. A method of fabricating an expandable vessel support having a radially tapered configuration when expanded, the method comprising the steps of:

forming a tube of polymeric material having a first and a second end,

sintering the first and second ends of the tube for a time period longer than a portion of the tube between the first and second ends to increase the radial tensile strength of the first and second ends and provide a radially tapered configuration to the tube when expanded.

29. The method of claim 28, wherein step of sintering occurs without restraining the tube.

30. A method of fabricating an expandable vessel support having a radially tapered configuration when expanded, the method comprising the steps of:

forming a tube of polymeric material having a first and a second end,

sintering the first and second ends of the tube for a time period shorter than a portion of the tube between the first and second ends to reduce the radial tensile strength of the first and second ends and provide a radially tapered configuration to the tube when expanded.

31. The method of claim 30, wherein step of sintering occurs without restraining the tube.