Implant deployment apparatus

• US 6,352,561 B1
• Filed: 12/23/1996
• Issued: 03/05/2002
• Est. Priority Date: 12/23/1996
• Status: Expired due to Term

• Current Assignee: W. L. Gore & Associates (W.L. Gore & Associates)
• Original Assignee: W. L. Gore & Associates (W.L. Gore & Associates)
• Inventors: Leopold, Eric W., Trautman, Joseph C., Breton, Thomas G., Pai, Suresh S., Chan, Randy S., Thornton, Troy
• Primary Examiner(s): Milano, Michael J.
• Application Number:
  US08/772,373
• Time in Patent Office: 1,898 Days
• Field of Search: 623/1, 623/12, 623/1.11, 623/1.23
• US Class Current: 623/1.23
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2/848 having means for fixation to the vessel wall, e.g. barbs
• 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 2/9522 Means for mounting a stent or stent-graft onto or into a placement instrument
• CPC Class Codes: A61F 2/9525 using a funnel
• CPC Class Codes: A61F 2/954 for placing stents or stent-grafts in a bifurcation
• CPC Class Codes: A61F 2/97 the outer sleeve being splittable
• CPC Class Codes: A61F 2002/067 modular
• CPC Class Codes: A61F 2002/075 the stent being loosely attached to the graft material, e.g. by stitching
• CPC Class Codes: A61F 2002/8486 provided on at least one of the ends
• CPC Class Codes: A61F 2002/9511 the retaining means being filaments or wires
• 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
• CPC Class Codes: A61F 2230/001 Figure-8-shaped, e.g. hourglass-shaped
• CPC Class Codes: A61F 2250/0059 temporary

Abstract

A delivery system including a restraining member maintains a collapsed implant in its collapsed state for delivery through a small passageway to a desired site in a mammalian body. Once the implant is positioned at the desired site, the restraining member is released so that the stent may expand or be expanded to its expanded state. In a preferred embodiment, the restraining member comprises a sheet of material that surrounds at least a portion of the collapsed stent. Portions of the restraining member are releasably coupled to one another with a low profile thread-like member or suture.

Claims

1. A device, comprising:

an expandable implant;

a sheet of material wrapped around said expandable implant, said sheet having first and second major surfaces and a plurality of openings extending from said first major surface to said second major surface; and

a coupling member cooperating with said openings for releasably coupling portions of the sheet to one another to maintain said expandable implant in a collapsed state.

2. The device of claim 1 wherein said sheet of material has a length and a width, said width being less than about 40 mm.

3. The device of claim 1, wherein said portions include side margins extending between longitudinal ends of said sheet of material, and at least two of said plurality of openings comprise eyelets disposed along at least one of said side margins.

4. The device of claim 3, wherein said eyelets are holes formed in said side margin.

5. The device of claim 3, including a loop coupled to said sheet, said loop forming said at least one of said eyelets.

6. The device of claim 3 wherein said coupling member comprises a thread adapted for threading through said eyelets.

7. The device of claim 1 wherein said implant comprises a stunt.

8. The device of claim 3, further including a reinforcing member, said reinforcing member being disposed between at least one of said eyelets and an outer perimeter of the side margin in which said at least one of said eyelets is disposed.

9. The device of claim 6, wherein at least one of said side margins comprises overlapping portions of said sheet, wherein a reinforcing member is positioned between said overlapping portions.

10. A device, comprising:

an expandable implant;

a sheet of material wrapped around said expandable implant;

a coupling member for releasably coupling portions of the sheet to one another to maintain said expandable implant in a collapsed state, wherein said portions include side margins extending between longitudinal ends of said sheet, and at least one opening is disposed along each of said side margins; and

a reinforcing member disposed between said at least one opening and an outer perimeter of the side margin.

11. A device, comprising:

an expandable implant;

a sheet of material wrapped around said expandable implant;

a reinforcing member; and

a coupling member for releasably coupling portions of the sheet to one another to maintain said expandable implant in a collapsed state, wherein said portions include side margins extending between longitudinal ends of said sheet of material, and at least one opening is disposed along each of said side margins, wherein at least one of said side margins comprises overlapping portions of said sheet, said reinforcing member being positioned between said overlapping portions.

12. The device of claim 11, wherein said coupling member comprises a thread adapted for threading through said at least one opening.

13. An assembly, comprising:

an implant having a collapsed state and an expanded state and including a stent; and

a sheet of material attached to said implant, said implant being in said collapsed state and having said sheet of material wrapped around at least a portion thereof, said sheet having ends and margin portions extending between said ends, said margin portions being releasably coupled to one another.

14. The assembly of claim 13 further including a discrete coupling member, said coupling member coupling said margin portions to one another.

15. The assembly of claim 13 wherein said sheet is arranged in generally tubular form to maintain said stent in said collapsed state.

16. The assembly of claim 13, wherein said sheet of material includes first and second major surfaces and a plurality of openings extending from said first major surface to said second major surface.

17. The assembly of claim 14, wherein the coupling member comprises a filament or thread-like element that forms at least one releasable knot.

18. A method for deploying a prosthesis in a lumen comprising the steps of:

(a) providing an expandable stent which is coupled to and restrained in a collapsed state by a restraining member,

(b) positioning said collapsed and restrained stent in a lumen having a wall,

(c) releasing said restraining member, and

(d) expanding said stent into a deployed configuration and urging said restraining member into a position against said wall.

19. The method of claim 18 wherein the stent is a self-expanding stent that is allowed to self-expand to urge the restraining member into a position against said wall.

20. The method of claim 18, wherein said restraining member includes first and second major surfaces and a plurality of openings extending from said first major surface to said second major surface.

21. The method of claim 18, wherein said restraining member includes side margins coupled together by a filament or thread-like element, which forms at least one releasable knot.

22. A method of assembling an implant, comprising the steps of:

placing a collapsed implant in a sheet of material having longitudinally extending side margins, said sheet having first and second major surfaces and a plurality of openings extending from said first major surface to said second major surface; and

coupling said side margins to each other to maintain said implant in a collapsed configuration.

23. The method of claim 22, wherein said coupling step comprises coupling said side margins with multiple elements such that multiple portions of the side margins may be released simultaneously.

24. A method of assembling an implant, comprising the steps of:

placing a collapsed implant in a sheet of material having longitudinally extending side margins; and

coupling said side margins to each other to maintain said implant in a collapsed configuration, wherein said coupling step comprises coupling said side margins with multiple elements such that multiple portions of the side margins may be released simultaneously.

25. A method for collapsing an expandable stent into a generally tubular restraining member comprising the steps of:

(a) pulling the stent through a tapered construct which radially collapses the stent, and

(b) positioning the stent into a restraining member, said restraining member having first and second major surfaces and a plurality of openings extending from said first major surface to said second major surface.

26. The method of claim 25 wherein a portion of said stent is folded before step (a).

27. A device, comprising:

a tubular support;

a sheet member attached to said tubular support and having at least one connectable free end; and

a coupling member for releasably connecting said at least one free end to said sheet member to maintain said support in a collapsed state.

28. The device of claim 27, wherein said sheet member has one free end.

29. The device of claim 27, wherein said sheet member has two free ends.

30. The device of claim 27, wherein said support includes a stent member.

31. The device of claim 28, wherein said support includes a graft member.

32. The device of claim 29, wherein sheet member is dimensioned to maintain said tubular support in a collapsed configuration when said free ends are connected to one another.

33. The device of claim 29, wherein said free ends include side margins extending between longitudinal ends, and at least one eyelet is disposed along each of said side margins.

34. The device of claim 33 wherein said coupling member extends through said eyelets to maintain said support in a collapsed configuration.

35. The device of claim 27 wherein the support comprises a stent-graft.

36. The device of claim 27, wherein said sheet member includes first and second major surfaces and a plurality of openings extending from said first major surface to said second major surface.

37. The device of claim 27, wherein said coupling member comprises a filament or thread-like element, which forms at least one releasable knot.

38. An assembly comprising:

a stent-graft having a collapsed and an expanded state; and

an attached restraining member,

said restraining member adapted to be wrapped around at least a portion of said stent-graft and having longitudinally extending side portions adapted to be releasibly coupled to each other to maintain said stent-graft in its collapsed state.

39. The assembly of claim 38 wherein said restraining member is a sheet of a polymeric material and has a length, width and thickness, said width being less than an expanded diameter of said stent-graft.

40. The assembly of claim 39 wherein said sheet has a width that is less than about 40 mm.

41. The assembly of claim 39 wherein the length of said restraining member, measured along a longitudinal axis thereof, is less than or equal to a length of said stent-graft.

42. The assembly of claim 38 further including a discrete member for releasibly coupling said portions to one another.

43. The assembly of claim 42, further including:

means for multidirectionally releasing the discrete member between said side portions.

44. The assembly of claim 38, wherein said side portions include side margins extending between respective ends of said stent-graft and contain at least one eyelet.

45. The assembly of claim 44 wherein said eyelet is formed by a hole formed in said margin.

46. The assembly of claim 44 wherein said eyelet comprises a loop coupled to said restraining member.

47. The assembly of claim 38, wherein said restraining member includes first and second major surfaces and a plurality of openings extending from said first major surface to said second major surface.

48. The assembly of claim 38, wherein said side portions are adapted to be releasably coupled by a coupling member comprising a filament or thread-like element, which forms at least one releasable knot.

49. A device, comprising:

an expandable implant;

a sheet of material wrapped around said expandable implant; and

a coupling member for releasably coupling portions of the sheet to one another to maintain said expandable implant in a collapsed state, wherein the coupling member comprises a filament or thread-like element that forms at least one releasable knot.

50. A device, comprising:

an expandable implant;

a sheet of material wrapped around and attached to said expandable implant; and

a coupling member for releasably coupling portions of the sheet to one another to maintain said expandable implant in a collapsed state.

51. A method of assembling an implant, comprising the steps of:

placing a collapsed implant in a sheet of material having longitudinally extending side margins; and

coupling said side margins to each other with a filament or thread-like element that forms at least one releasable knot to maintain said implant in a collapsed configuration.

52. A method of assembling an implant, comprising the steps of:

placing a collapsed implant in a sheet of material having longitudinally extending side margins;

coupling said side margins to each other to maintain said implant in a collapsed configuration; and

attaching said implant to said sheet of material.

53. A method for collapsing an expandable stent into a generally tubular restraining member comprising the steps of:

(a) pulling an expandable stent through a tapered construct which radially collapses the stent;

(b) positioning the stent into a restraining member having side margins; and

(c) coupling said side margins together with a filament or thread-like element and forming at least one releasable knot to maintain said stent in a collapsed configuration.

54. A method for collapsing an expandable implant into a generally tubular restraining member comprising the steps of:

(a) pulling an expandable implant through a tapered construct which radially collapses the implant;

(b) positioning the implant into a restraining member having side margins; and

(c) attaching the implant to said restraining member.