Folding self-expandable intravascular stent-graft

• US 6,001,123 A
• Filed: 05/28/1996
• Issued: 12/14/1999
• Est. Priority Date: 04/01/1994
• Status: Expired due to Term

• Current Assignee: W. L. Gore & Associates (W.L. Gore & Associates)
• Original Assignee: Gore Enterprise Holdings Incorporated
• Inventors: Lau, Lilip
• Primary Examiner(s): Milano, Michael J.
• Application Number:
  US08/654,050
• Time in Patent Office: 1,295 Days
• Field of Search: 623/1, 623/11, 623/12, 604/108, 604/194, 604/198, 128/898
• US Class Current: 623/1.12
• 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 2/91 made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
• CPC Class Codes: A61F 2/915 with bands having a meander structure, adjacent bands being connected to each other
• CPC Class Codes: A61F 2/92 Stents in the form of a rolled-up sheet expanding after insertion into the vessel , e.g. with a spiral shape in cross-section
• CPC Class Codes: A61F 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61F 2002/061 provided with means for allowing access to secondary lumens
• 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 2002/3008 radio-opaque, e.g. radio-opaque markers
• CPC Class Codes: A61F 2002/30092 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2002/30462 retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61F 2002/91558 connected peak to peak
• CPC Class Codes: A61F 2002/91575 connected peak to trough
• CPC Class Codes: A61F 2002/9511 the retaining means being filaments or wires
• 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 2220/0058 soldered or brazed or welded
• CPC Class Codes: A61F 2230/0041 J-shaped
• CPC Class Codes: A61F 2230/006 Y-shaped
• CPC Class Codes: A61F 2250/0098 : radio-opaque, e.g. radio-opaque markers
• CPC Class Codes: A61F 2310/00017 : Iron- or Fe-based alloys, e.g. stainless steel
• CPC Class Codes: A61F 2310/00023 : Titanium or titanium-based alloys, e.g. Ti-Ni alloys
• CPC Class Codes: A61F 2310/00029 : Cobalt-based alloys, e.g. Co-Cr alloys or Vitallium
• CPC Class Codes: A61F 2310/00137 : Tungsten or W-based alloys
• CPC Class Codes: A61F 2310/00149 : Platinum or Pt-based alloys

Abstract

This invention is a medical device and a method of using it. The device is a foldable stent or stent-graft which may be percutaneously deliverable with (or on) an endovascular catheter or via other surgical or other techniques and then expanded. The expandable stent structure utilizes at least one torsional sector which allows it to be folded to a very small diameter prior to deployment as a stent The stent may be expanded with the use of an installation device such as a balloon but preferably is used as a self-expandable device. The stent may be flared on at least one of its ends to promote smooth blood flow at that flare and to assure that the stent will remain in the chosen position within the body. The stent'"'"'s configuration allows it to be folded or otherwise compressed to a very small diameter prior to deployment without changing the length of the stent. The graft component cooperating with the stent is tubular and preferably is a bloodcompatible collagenous material which may, if desired, be reinforced with fibers. The tubular member may be cast onto or otherwise attached or irnbedded into the stent structure to form a stent-graft.

Claims

1. A device comprising a self-expanding stent that is expandable from a folded state to an unfolded generally tubular state with an axis, wherein said stent is longitudinally folded along a fold line which is generally parallel to said axis, said stent having at least one member and a pair of laterally spaced arms extending from said member, said member extending approximately parallel to said axis when said stent is in its unfolded state, at least a portion of said member being substantially aligned with said fold line so that at least a portion of one of said pair of laterally spaced arms extends from said member along a different side of said fold line than the other of said pair of laterally spaced arms.

2. The device of claim 1 wherein said stent comprises an undulating member that circumferentially extends around said passageway, wherein said at least one member and said pair of laterally spaced arms form at least a part of said undulating member.

3. The device of claim 2 wherein said undulating member is arranged in the form of a ring.

4. The device of claim 3 including a pair of said undulating members.

5. The device of claim 4 wherein said undulating members do not overlap one another.

6. The device of claim 4 further including a tie member interconnecting said undulating members.

7. The device of claim 1 wherein said stent is releasably restrained in said folded state with at least a substantial portion of said at least one member being approximately parallel to said axis.

8. The device of claim 1 wherein said at least one member comprises multiple members, each having a pair of laterally spaced arms extending therefrom, said folded stent being folded along multiple fold lines with at least a portion of one of said multiple members being substantially aligned with each of said fold lines, respectively, such that at least a portion of one of said pair of arms extending from each respective member, extends on a different side of said respective fold line from the other of said pair of arms extending from each respective member, such that each of said members is under torsion and tends to urge said stent toward said unfolded state.

9. The device of claim 1 wherein said fold line is approximately parallel to the longitudinal axis of the unfolded stent.

10. The device of claim 1 wherein said stent comprises a stainless steel material.

11. The device of claim 10 wherein said stent comprises nitinol.

12. The device of claim 10 wherein said stent comprises a sheet material.

13. The device of claim 10 wherein said stent comprises a wire material.

14. The device of claim 10 wherein said stent is produced from tubing.

15. The device of claim 1 further comprising a tubular gaft member coupled to and generally coaxial with at least a portion of said stent.

16. The device of claim 15 wherein the tubular member comprises a polyethylene terephthalate material.

17. The device of claim 15 wherein the tubular member comprises a collagen-based material.

18. The device of claim 17 further comprising reinforcing fibers within said tubular graft member.

19. The device of claim 18 further comprising radiopaque fibers within said tubular graft member.

20. The device of claim 15 wherein the tubular member comprises a polymeric non-thrombogenic material.

21. The device of claim 1 further comprising a tubular member both interior to and exterior to said stent, and being generally coaxial therewith.

22. The device of claim 21 wherein the tubular member comprises polyethylene terephthalate.

23. The device of claim 21 wherein the tubular member comprises a collagen-based material.

24. The device of claim 23 further comprising reinforcing fibers within said tubular member.

25. The device of claim 24 further comprising radiopaque fibers within said tubular member.

26. The device of claim 21 wherein the tubular member comprises a polymeric non-thrombogenic material.

27. The device of claim 15 wherein the tubular member is frangible.

28. The device of claim 17 wherein the collagen-based material is cast.

29. The device of claim 17 where wherein the collagen-based material adheres to or partially encapsulates the stent.

30. The device of claim 17 wherein the collagen-based material adheres to the interior of the stent.

31. The device of claim 17 wherein the collagen-based material additionally adheres to or partially encapsulates the exterior of the stent.

32. The device of claim 10 wherein said stent comprises a cobalt chromium alloy material.

33. The device of claim 10 wherein said stent comprises a cobalt platinum/tungsten alloy material.

34. The device of claim 10 wherein said stent comprises a cobalt nickel-titanium alloy material.

35. The device of claim 15 wherein the tubular member comprises a polytetrafluoroethylene polymer.

36. The device of claim 15 wherein the tubular member comprises a polytetrafluoroethylene copolymer including hexafluoropropylene.

37. The device of claim 15 wherein the tubular member comprises a polyaramid material.

38. The device of claim 15 wherein the tubular member comprises a porous polyurethane material.

39. The device of claim 21 wherein the tubular member comprises a polytetrafluoroethylene polymer.

40. The device of claim 21 wherein the tubular member comprises a polytetrafluoroethylene copolymer including hexafluoropropylene.

41. The device of claim 21 wherein the tubular member comprises a polyaramid material.

42. The device of claim 21 wherein the tubular member comprises a porous polyurethane material.

43. A device, comprising:

a self-expanding stent that is expandable from a folded state to an unfolded state, said self-expanding stent having

a substantially cylindrical body when in the unfolded state,

a longitudinal axis,

multiple rings that make up said substantially cylindrical body, each of said multiple rings comprising undulations which undulate substantially in a direction of said longitudinal axis,

first and second loops on a circumference of said self-expanding stent and substantially aligned in a direction parallel to said longitudinal axis, said first and second loops formed by said undulations, and being substantially aligned for coupling when said self-expanding stent is in the folded state.

a releasing mechanism coupled to said self-expanding stent when said self-expanding stent is in the folded state, said releasing mechanism comprises a tether line which passes through said first and second loops to restrain said self-expanding stent in the folded state,

wherein, upon uncoupling said releasing mechanism from said self-expanding stent. said self-expanding stent self-expands from the folded state to the unfolded state.

44. A device, comprising:

a self-expanding stent that is expandable from a folded state to an unfolded state, said self-expanding stent having

a substantially cylindrical body when in the unfolded state,

a longitudinal axis,

multiple rings that make up said substantially cylindrical body, each of said multiple rings comprising undulations which undulate substantially in a direction of said longitudinal axis,

first and second loops on a circumference of said self-expanding stent and substantially aligned in a direction parallel to said longitudinal axis, said first and second loops connected to said undulations, and being substantially aligned for coupling when said self-expanding stent is in the folded state,

a releasing mechanism coupled to said self-expanding stent when said self-expanding stent is in the folded state, said releasing mechanism comprises a tether line which passes through said first and second loops to restrain said self-expanding stent in the folded state,

wherein, upon uncoupling said releasing mechanism from said self-expanding stent, said self-expanding stent self-expands from the folded state to the unfolded state.

45. A device, comprising:

a self-expanding stent that is expandable from a folded state to an unfolded state, said self-expanding stent having

a substantially cylindrical body when in the unfolded state,

a longitudinal axis,

first and second loops on a circumference of said self-expanding stent and substantially aligned in a direction parallel to said longitudinal axis, said first and second loops integrally formed in said substantially cylindrical body, and being substantially aligned for coupling when said self-expanding stent is in the folded state,

a releasing mechanism coupled to said self-expanding stent when said self-expanding stent is in the folded state, said releasing mechanism comprises a tether line which passes through said first and second loops to restrain said self-expanding stent in the folded state,

wherein, upon uncoupling said releasing mechanism from said self-expanding stent, said self-expanding stent self-expands from the folded state to the unfolded state.

46. A device, comprising:

a self-expanding stent that is expandable from a folded state to an unfolded state, said self-expanding stent having

a substantially cylindrical body when in the unfolded state,

a longitudinal axis,

first and second loops on a circumference of said self-expanding stent and substantially aligned in a direction parallel to said longitudinal axis, said first and second loops integrally formed in said substantially cylindrical body, and being substantially aligned for coupling when said self-expanding stent is in the folded state,

a releasing mechanism coupled to said self-expanding stent when said self-expanding stent is in the folded state, said releasing mechanism comprises a tether line which passes through said first and second loops to restrain said self-expanding stent in the folded state,

wherein, upon uncoupling said releasing mechanism from said self-expanding stent, said self-expanding stent self-expands from the folded state to the unfolded state.

47. A device for introduction into a body lumen, said device comprising a self-expanding stent, said stent comprising at least one undulating member arranged in a generally ring shaped configuration, said undulating member being expandable from a folded state, where said stent is folded along a line generally parallel a longitudinal axis of said stent, to an unfolded state, where said stent assumes a generally tubular configuration, a portion of said undulating member being substantially aligned with said fold line and extending approximately parallel to said longitudinal axis.

48. The device of claim 47 wherein said device is releasably restrained in said folded state.

49. The device of claim 47 wherein said stent comprises at least two of said ring-shaped-undulating members.

50. The device of claim 49 further including tie members that interconnect said undulating members.

51. The device of claim 49 wherein said undulating members are integrally formed.

52. The device of claim 47 wherein said undulating member includes two laterally spaced arms extending from said undulating member portion, a portion of each of said arms extending along a different side of said fold line than the other of said arms such that when said stent is in said folded state, said undulating member portion is placed under torsion and tends to urge the stent toward said unfolded state.

53. A device for introduction into a mammalian body comprising:

a self-expanding stent suitable for introduction into the mammalian body, said stent having two ends, a longitudinal axis, a passageway between said ends, said stent further comprising at least one ring assembly extending circumferentially about said passageway, at least a portion of at least one said ring assembly situated so that when said stent is folded along said longitudinal axis to form at least one fold, said at least a portion is twisted; and

a removable slip line extending between said two ends for holding said stent in position when folded.

54. The device of claim 53 which said self expanding stent comprises loops arranged generally in a line substantially parallel to said longitudinal axis, said loops generally aligning along said at least one fold upon folding said stent, for receiving said slip line;

wherein said slip line is introduced through said loops to maintain said stent in a folded configuration.

55. The device of claim 53 wherein said stent is metallic.

56. The device of claim 53 wherein said stent comprises a super-elastic alloy.

57. The device of claim 53 wherein said stent comprises nitinol.

58. The device of claim 53 wherein said at least one ring assembly comprises undulating elements defining a ring shape which forms at least a portion of said passageway.

59. The device of claim 58 wherein said stent further comprises at least one flexible link passing through at least one of said undulating elements, and maintaining said at least one of said undulating elements in an aligned position.

60. The device of claim 53 wherein at least one ring assembly comprises a plurality of ring assemblies, each of said plurality of ring assemblies comprising undulating elements defining a ring shape which forms at least a portion of said passageway;

said stent additionally comprising at least one flexible link passing through said undulating elements of at least two of said plurality of ring assemblies.

61. The device of claim 60 wherein said ring assemblies are arranged so that said undulating elements are in an intercooperating phased relationship.

62. The device of claim 60 wherein said at least one flexible link maintains said undulating elements in a phased relationship.

63. The device of claim 53 further comprising a tubular member attached to said stent.

64. The device of claim 63 wherein said tubular member comprises a polymeric nonthrombogenic material.

65. The device of claim 63 wherein said tubular member comprises a collagen-based material.

66. The device of claim 63 wherein said tubular member comprises a material selected from polyethylene terepthalate, polytetrafluoroethylene, polytetrafluoroethylene with hexafluoropropylene, polyaramids, and porous polyurethane.

67. The device of claim 63 wherein said tubular member further comprises reinforcing fibers.

68. The device of claim 63 wherein said tubular member further comprises radiopaque fibers.