Kink resistant stent-graft

• US 6,520,986 B2
• Filed: 06/26/2001
• Issued: 02/18/2003
• Est. Priority Date: 12/14/1995
• Status: Expired due to Term

• Current Assignee: W. L. Gore & Associates (W.L. Gore & Associates)
• Original Assignee: Gore Enterprise Holdings Incorporated
• Inventors: Martin, Gerald Ray, Thornton, Troy, Lam, Sharon, Stonebrook, Scott N., Lau, Lilip
• Primary Examiner(s): Milano, Michael J.
• Assistant Examiner(s): HO, UYEN T
• Application Number:
  US09/888,499
• Publication Number:
  US 20020002397A1
• Time in Patent Office: 602 Days
• Field of Search: 623/1.1, 623/1--, 623/1.25, 623/1-7-, 623/1--, 606/108, 606/191, 606/198
• US Class Current: 623/1.13
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2/844 folded prior to deployment
• 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 2/89 the wire-like elements comprising two or more adjacent rings flexibly connected by separate members
• CPC Class Codes: A61F 2/90 characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61F 2002/075 the stent being loosely attached to the graft material, e.g. by stitching
• CPC Class Codes: A61F 2002/9511 the retaining means being filaments or wires
• CPC Class Codes: A61F 2002/9665 with additional retaining means
• CPC Class Codes: A61F 2210/0019 operated at only one temperature whilst inside or touching the human body, e.g. constrained in a non-operative shape during surgery, another temperature only occurring before the operation
• CPC Class Codes: A61F 2220/0075 sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61F 2220/0091 connected by a hinged linkage mechanism, e.g. of the single-bar or multi-bar linkage type
• CPC Class Codes: A61F 2230/0041 J-shaped
• CPC Class Codes: A61F 2230/006 Y-shaped
• CPC Class Codes: A61F 2230/0078 hyperboloidal
• CPC Class Codes: A61F 2250/0098 radio-opaque, e.g. radio-opaque markers

Abstract

A stent-graft including a stent member having an inner surface and an outer surface, a generally tubular graft member and a coupling member that couples the stent member to the graft member. The coupling member, which is the preferred embodiment is in the form of a ribbon, covers only a portion of the inner or outer surface of the stent member and secures the stent member and graft member to one another. Alternatively, the coupling member can be described as interconnecting less than entirely the inner or outer surface of the graft member to the stent member. With this construction, regions of the stent member do not interfere with the coupling member. Shear stresses between the stent member and the coupling member and the risk of tearing the graft or coupling member or delamination therebetween may be reduced as compared to a fully enveloped stent member. This construction also provides improved flexibility and kink resistance.

Claims

1. A stent-graft comprising:

a substantially tubular shaped stent member having an inner surface, an outer surface, and configured from multiple turns of an undulating element, said stent member having substantially in-phase undulations;

a generally tubular graft member arranged within said stent member; and

a ribbon adhered in contact with only a portion of at least one of the inner and outer surfaces of said stent member and securing the stent member and graft member to one another thereby permitting unrestrained movement of at least a portion of at least one of said undulations relative to at least said graft member.

2. The stent-graft of claim 1 wherein said undulating element is arranged in a helical configuration.

3. The stent-graft of claim 2 wherein said ribbon is arranged in a helical configuration with multiple turns, each turn being spaced from an adjacent turn.

4. The stent graft of claim 3 wherein the spacing between said turns is uniform.

5. The stent-graft of claim 3 wherein said ribbon covers a portion of at least one of said undulations.

6. The stent-graft of claim 3 wherein said ribbon is interwoven into a plurality of said undulations.

7. The stent graft of claim 3 further including a linking member threaded between adjacent turns to maintain undulation in adjacent turns generally in-phase with one another.

8. The stent-graft of claim 7 wherein a plurality of said undulations are configured to permit therein unrestrained movement of an undulation generally in-phase therewith.

9. The stent-graft of claim 3 wherein a group of said undulations forms a sinusoidal curve.

10. The stent-graft of claim 3 wherein said ribbon has a width less than or equal to about three-fourths the average amplitude, measured peak-to-peak, of at least one of said undulations.

11. The stent-graft of claim 10 wherein said ribbon has a width less than or equal to about two-thirds the average amplitude, measured peak-to-peak, of at least one of said undulations.

12. The stent-graft of claim 1 wherein said graft member has an average thickness of less than or equal to about 0.006 inch.

13. The stent-graft of claim 12 wherein said ribbon has an average thickness less than or equal to about 0.005 inch.

14. The stent-graft of claim 1 wherein said graft member comprises porous expanded polytetrafluoroethylene.

15. The stent-graft of claim 14 wherein said ribbon comprises porous expanded polytetrafluoroethylene.

16. The stent-graft of claim 1 wherein said graft member comprises radiopaque fibers.

17. The stent-graft of claim 1 wherein said stent member comprises nitinol.

18. The stent-graft of claim 1 wherein said ribbon is adhesively bonded to said graft member.

19. The stent-graft of claim 1 wherein said ribbon has a generally flat portion that faces said graft member.

20. A stent-graft comprising:

an undulating stent member with substantially in-phase undulations having an inner surface and an outer surface;

a generally tubular graft member having an inner surface and an outer surface, one of said stent and graft members surrounding at least a portion of the other; and

a discrete ribbon adhered to at least one of said inner and outer surfaces of said stent member to attach said stent member and graft member to one another.

21. The stent-graft of claim 20 wherein said ribbon is arranged to include multiple helical turns, at least one of said turns being spaced from a turn adjacent thereto.

22. The stent-graft of claim 20 wherein said ribbon has a generally flat portion that faces said graft member.

23. The stent-graft of claim 20 wherein said stent member is tubular, said stent and graft members are generally coaxial, and said graft member is disposed in said stent member.

24. A stent-graft comprising:

a generally tubular stent member having inner and outer circumferences, said stent member including a first member and second member, said first member being arranged in a helical configuration with multiple helical turns and having multiple undulations, each having an apex, said second member being threaded through adjacent apexes in adjacent turns to maintain undulations in adjacent turns generally in-phase with one anther;

a generally flat ribbon helically arranged and disposed to contact at least one of said inner and outer circumferences of said stent member and forming multiple windings spaced from one anther; and

a generally tubular graft member disposed between said stent member and said helically arranged ribbon and including portions secured to said ribbon.

25. The stent graft of claim 24 wherein said helically would ribbon is generally spaced from said apexes and forms therewith respective openings, said apexes being configured to permit unrestrained movement of said second member within said openings.

26. A method of deploying a stent graft comprising the steps of:

(a) providing a stent-graft having a substantially tubular stent member having an inner surface, an outer surface, and configured from multiple turns of an undulating element, said stent member having substantially in-phase undulations;

a generally tubular graft member arranged within said stent member; and

a ribbon adhered in contact with only a portion of at least one of the inner and outer surfaces of said stent member and securing the stent member and graft member to one another thereby permitting unrestrained movement of at least a portion of at least one undulation relative to at least said graft member;

(b) positioning said stent-graft at a site in a mammal; and

(c) deploying said stent-graft at said site.