Coiled sheet graft stent and methods of making and use

• US 5,824,054 A
• Filed: 03/18/1997
• Issued: 10/20/1998
• Est. Priority Date: 03/18/1997
• Status: Expired due to Term

• Current Assignee: Endotex Interventional Systems Incorporated (Boston Scientific Corporation)
• Original Assignee: Endotex Interventional Systems Incorporated (Boston Scientific Corporation)
• Inventors: Spiridigliozzi, John, Khosravi, Farhad, Hogendijk, Michael, Ross, Michael R.
• Primary Examiner(s): Prebilic, Paul B.
• Application Number:
  US08/820,213
• Time in Patent Office: 581 Days
• Field of Search: 623/1, 623/12, 606/191, 606/194, 606/198
• US Class Current: 623/1.44
• CPC Class Codes: A61F 2/07 Stent-grafts
• 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 2002/065 Y-shaped blood vessels
• CPC Class Codes: A61F 2002/075 the stent being loosely attached to the graft material, e.g. by stitching
• CPC Class Codes: A61F 2210/0076 multilayered, e.g. laminated structures
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2220/005 using adhesives
• CPC Class Codes: A61F 2220/0075 sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable

Abstract

A prosthesis is provided for treatment of aneurysms, occlusive disease of vessels and body organs, and arterio-venous fistulas, comprising an expandable coiled sheet portion having a biocompatible graft affixed thereto. The graft material, preferably a polytetrafluoroethylene ("PTFE") or polyesther material, is affixed to the coiled sheet portion by sintering, suturing, or bonding using a biocompatible adhesive. The coiled sheet portion comprises a lattice formed from a biocompatible material, and may include one or more rows of locking teeth adjacent one edge of the coiled sheet that interengage openings in an opposing edge of the coiled sheet portion to retain the prosthesis at a desired expanded diameter. The prosthesis has a small delivery profile, making it suitable for use in a variety of body vessels. Methods of making and deploying the prosthesis are also provided.

Claims

1. A prosthesis for treating a section of a body lumen, the prosthesis comprising:

a coiled sheet portion having a contracted state wherein the coiled sheet portion is wound to a first diameter to form a series of overlapping turns, and an expanded state wherein the coiled sheet portion forms a tubular member having a second diameter greater than the first diameter, the coiled sheet portion expandable to the expanded state when released from the contracted state; and

a graft material that is biocompatible affixed to the coiled sheet portion by a biocompatible adhesive, the graft material being wound within the overlapping turns of the coiled sheet portion when the coiled sheet portion is in the contracted state.

2. The prosthesis as defined in claim 1 wherein the coiled sheet portion further includes a plurality of teeth adjacent to an inner edge of the coiled sheet portion and a plurality of openings disposed on an opposing overlapping edge of the coiled sheet portion, the plurality of teeth interengaging the plurality of openings to lock the coiled sheet portion in the expanded state.

3. The prosthesis as defined in claim 2 wherein the coiled sheet portion further comprises a biocompatible material.

4. The prosthesis as defined in claim 1 wherein the graft material is also affixed to the coiled sheet portion by biocompatible sutures or stitches.

5. The prosthesis as defined in claim 1 wherein the graft material is affixed to an exterior surface of the coiled sheet portion.

6. The prosthesis as defined in claim 1 wherein the graft material is affixed to an interior surface of the coiled sheet portion.

7. The prosthesis as defined in claim 1 wherein the coiled sheet portion further includes a first end and a plurality of radially outwardly directed projections in a region disposed near a first end that engage an interior surface of the body lumen where the coiled sheet portion expands to the expanded state.

8. The prosthesis as defined in claim 1 wherein coiled sheet portion forms a tubular member having a longitudinal seam when the coiled sheet portion expands to the expanded state, the prosthesis further comprising a flap of graft material that extends from a longitudinal edge of the coiled sheet portion, the flap overlapping and sealing the longitudinal seam when the coiled sheet portion expands to the expanded state.

9. The prosthesis as defined in claim 1 wherein the coiled sheet portion further includes a portion defining a multiplicity of openings.

10. The prosthesis as defined in claim 9 wherein the multiplicity of openings includes openings of different sizes and orientations that improve the longitudinal flexibility of the coiled sheet portion.

11. The prosthesis as defined in claim 9 wherein the coiled sheet portion has an interior surface and an exterior surface, and the graft material is disposed on the interior surface, the prosthesis further comprising a layer of a biocompatible material disposed on the exterior surface.

12. The prosthesis as defined in claim 1 wherein the coiled sheet portion comprises first and second coiled sheet members, the graft material being interposed between the first and second coiled sheet portions.

13. The prosthesis as defined in claim 1 wherein the coiled sheet portion comprises a nickel-titanium alloy.

14. The prosthesis as defined in claim 1 wherein the graft material is polytetrafluoroethylene.

15. The prosthesis as defined in claim 1 wherein the biocompatible adhesive is a urethane compound.

16. The prosthesis as defined in claim 1 wherein the prosthesis has an overlapping edge and an exterior surface, the overlapping edge spiraling around the exterior surface in the expanded state.

17. The prosthesis as defined in claim 1 wherein the coiled sheet portion further includes a plurality of articulations that provide longitudinal flexibility of the prosthesis when transported through a tortuous body lumen.

18. The prosthesis as defined in claim 1 wherein the graft material is impregnated with at least one drug.

19. A prosthesis for treating a section of a body lumen, the prosthesis comprising:

a coiled sheet portion having a contracted state wherein the coiled sheet portion is wound to a first diameter to form a series of overlapping turns, and an expanded state wherein the coiled sheet portion forms a tubular member having a second diameter greater than the first diameter, the coiled sheet portion expandable to the expanded state when released from the contracted state; and

a graft material that is biocompatible affixed to the coiled sheet portion by biocompatible sutures or stitches, the graft material being wound within the overlapping turns of the coiled sheet portion when the coiled sheet portion is in the contracted state.

20. The prosthesis as defined in claim 19 wherein the coiled sheet portion further includes a plurality of teeth adjacent to an inner edge of the coiled sheet portion and a plurality of openings disposed on an opposing overlapping edge of the coiled sheet portion, the plurality of teeth interengaging the plurality of openings to lock the coiled sheet portion in the expanded state.

21. The prosthesis as defined in claim 20 wherein the coiled sheet portion further comprises a biocompatible material.

22. The prosthesis as defined in claim 19 wherein the graft material is also affixed to the coiled sheet portion by a biocompatible adhesive.

23. The prosthesis as defined in claim 19 wherein the graft material is affixed to an exterior surface of the coiled sheet portion.

24. The prosthesis as defined in claim 19 wherein the graft material is affixed to an interior surface of the coiled sheet portion.

25. The prosthesis as defined in claim 19 wherein the coiled sheet portion includes a first end and a plurality of radially outwardly directed projections in a region disposed near a first end that engage an interior surface of the body lumen when the coiled sheet portion expands to the expanded state.

26. The prosthesis as defined in claim 19 wherein coiled sheet portion forms a tubular member having a longitudinal seam when the coiled sheet portion expands to the expanded state, the prosthesis further comprising a flap of graft material that extends from a longitudinal edge of the coiled sheet portion, the flap overlapping and sealing the longitudinal seam when the coiled sheet portion expands to the expanded state.

27. The prosthesis as defined in claim 19 wherein the coiled sheet portion further includes a portion defining a multiplicity of openings.

28. The prosthesis as defined in claim 27 wherein the multiplicity of openings includes openings of different sizes and orientations that improve the longitudinal flexibility of the coiled sheet portion.

29. The prosthesis as defined in claim 27 wherein the coiled sheet portion has an interior surface and an exterior surface, and the graft material is disposed on the interior surface, the prosthesis further comprising a layer of a biocompatible material disposed on the exterior surface.

30. The prosthesis as defined in claim 19 wherein the coiled sheet portion comprises first and second coiled sheet members, the graft material being interposed between the first and second coiled sheet portions.

31. The prosthesis as defined in claim 19 wherein the coiled sheet portion comprises a nickel-titanium alloy.

32. The prosthesis as defined in claim 19 wherein the graft material is polytetrafluoroethylene.

33. The prosthesis as defined in claim 19 wherein the biocompatible adhesive is a urethane compound.

34. The prosthesis as defined in claim 19 wherein the prosthesis has an overlapping edge and an exterior surface, the overlapping edge spiraling around the exterior surface in the expanded state.

35. The prosthesis as defined in claim 19 wherein the coiled sheet portion further includes a plurality of articulations that provide longitudinal flexibility of the prosthesis when transported through a tortuous body lumen.

36. The prosthesis as defined in claim 19 wherein the graft material is impregnated with at least one drug.

37. A prosthesis for treating a section of a body lumen, the prosthesis comprising:

a coiled sheet portion having a contracted state wherein the coiled sheet portion is wound to a first diameter to form a series of overlapping turns, and an expanded state wherein the coiled sheet portion forms a tubular member having a longitudinal seam and a second diameter greater than the first diameter, the coiled sheet portion expandable to the expanded state when released from the contracted state; and

a graft material that is biocompatible affixed to the coiled sheet portion, the graft material having a portion comprising a flap that extends beyond longitudinal edge of the coiled sheet portion, the graft material being wound within the overlapping turns of the coiled sheet portion when the coiled sheet portion is in the contracted state, the graft material forming a permanent substantially fluid-tight lumen when the coiled sheet portion expands to the expanded state, wherein the flap overlaps and seals the longitudinal seam.

38. The prosthesis as defined in claim 37 wherein the coiled sheet portion further includes a plurality of teeth adjacent to an inner edge of the coiled sheet portion and a plurality of openings disposed on an opposing overlapping edge of the coiled sheet portion, the plurality of teeth interengaging the plurality of openings to lock the coiled sheet portion in the expanded state.

39. The prosthesis as defined in claim 38 wherein the coiled sheet portion further comprises a biocompatible material.

40. The prosthesis as defined in claim 37 wherein the graft material is affixed to the coiled sheet portion by a biocompatible adhesive.

41. The prosthesis as defined in claim 37 wherein the graft material is affixed to the coiled sheet portion by sintering.

42. The prosthesis as defined in claim 37 wherein the graft material is affixed to the coiled sheet portion by biocompatible sutures or stitches.

43. The prosthesis as defined in claim 37 wherein the graft material is affixed to an exterior surface of the coiled sheet portion.

44. The prosthesis as defined in claim 37 wherein the graft material is affixed to an interior surface of the coiled sheet portion.

45. The prosthesis as defined in claim 37 wherein the coiled sheet portion includes a first end and a plurality of radially outwardly directed projections in a region disposed near a first end that engage an interior surface of the body lumen when the coiled sheet portion expands to the expanded state.

46. The prosthesis as defined in claim 37 wherein the coiled sheet portion further includes a portion defining a multiplicity of openings.

47. The prosthesis as defined in claim 46 wherein the multiplicity of openings includes openings of different sizes and orientations that improve the longitudinal flexibility of the coiled sheet portion.

48. The prosthesis as defined in claim 46 wherein the coiled sheet portion has an interior surface and an exterior surface, and the graft material is disposed on the interior surface, the prosthesis further comprising a layer of a biocompatible material disposed on the exterior surface.

49. The prosthesis as defined in claim 48 wherein the graft material is sintered so that the first layer is fused to the second layer through the multiplicity of openings.

50. The prosthesis as defined in claim 37 wherein the coiled sheet portion comprises first and second coiled sheet members, the graft material being interposed between the first and second coiled sheet portions.

51. The prosthesis as defined in claim 37 wherein the coiled sheet portion comprises a nickel-titanium alloy.

52. The prosthesis as defined in claim 37 wherein the graft material is polytetrafluoroethylene.

53. The prosthesis as defined in claim 40 wherein the biocompatible adhesive is a urethane compound.

54. The prosthesis as defined in claim 37 wherein the prosthesis has an overlapping edge and an exterior surface, the overlapping edge spiraling around the exterior surface in the expanded state.

55. The prosthesis as defined in claim 37 wherein the coiled sheet portion further includes a plurality of articulations that provide longitudinal flexibility of the prosthesis when transported through a tortuous body lumen.

56. The prosthesis as defined in claim 37 wherein the graft material is impregnated with at least one drug.

57. A prosthesis for treating a section of a body lumen, the prosthesis comprising:

a coiled sheet portion having an interior surface, an exterior surface, and a multiplicity of openings, the coiled sheet portion having a contracted state wherein the coiled sheet portion is wound to a first diameter to form a series of overlapping turns, and an expanded state wherein the coiled sheet portion forms a tubular member having a second diameter greater than the first diameter, the coiled sheet portion expandable to the expanded state when released from the contracted state; and

a graft material that is biocompatible, the graft material comprising a first layer disposed on the interior surface and a second layer disposed on the exterior surface, the first and second layers sintered together so that the first layer is fused to the second layer through the multiplicity of openings, the graft material being wound within the overlapping turns of the coiled sheet portion when the coiled sheet portion is in the contracted state, the graft material forming a permanent substantially fluid-tight lumen when the coiled sheet portion expands to the expanded state.

58. The prosthesis as defined in claim 57 wherein the coiled sheet portion further includes a plurality of teeth adjacent to an inner edge of the coiled sheet portion and a plurality of openings disposed on an opposing overlapping edge of the coiled sheet portion, the plurality of teeth interengaging the plurality of openings to lock the coiled sheet portion in the expanded state.

59. The prosthesis as defined in claim 57 wherein the coiled sheet portion further comprises a biocompatible material.

60. The prosthesis as defined in claim 57 wherein the coiled sheet portion includes a first end and a plurality of radially outwardly directed projections in a region disposed near a first end that engage an interior surface of the body lumen when the coiled sheet portion expands to the expanded state.

61. The prosthesis as defined in claim 57 wherein coiled sheet portion forms a tubular member having a longitudinal seam when the coiled sheet portion expands to the expanded state, the prosthesis further comprising a flap of graft material that extends beyond a longitudinal edge of the coiled sheet portion, the flap overlapping and sealing the longitudinal seam when the coiled sheet portion expands to the expanded state.

62. The prosthesis as defined in claim 57 wherein the multiplicity of openings includes openings of different sizes and orientations that improve the longitudinal flexibility of the coiled sheet portion.

63. The prosthesis as defined in claim 57 wherein the coiled sheet portion comprises a nickel-titanium alloy.

64. The prosthesis as defined in claim 57 wherein the graft material is polytetrafluoroethylene.

65. The prosthesis as defined in claim 57 wherein the prosthesis has an overlapping edge and an exterior surface, the overlapping edge spiraling around the exterior surface in the expanded state.

66. The prosthesis as defined in claim 57 wherein the coiled sheet portion further includes a plurality of articulations that provide longitudinal flexibility of the prosthesis when transported through a tortuous body lumen.

67. The prosthesis as defined in claim 57 wherein the graft material is impregnated with at least one drug.