Implant deployment apparatus

• US 20020029077A1
• Filed: 11/05/2001
• Published: 03/07/2002
• Est. Priority Date: 12/23/1996
• Status: Abandoned Application

• Current Assignee: W. L. Gore & Associates (W.L. Gore & Associates)
• Original Assignee: W. L. Gore & Associates (W.L. Gore & Associates)
• Inventors: Trautman, Joseph C., Breton, Thomas G., Pai, Suresh S., Leopold, Eric W., Chan, Randy S., Thornton, Troy
• Application Number:
  US09/985,498
• Publication Number:
  US 20020029077A1
• Time in Patent Office: Days
• US Class Current: 623/1.11
• 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 delivery system for temporarily restraining an expandable implant in a collapsed state for delivery to a deployment site, said system comprising a sheet of material adapted and configured for wrapping around an expandable implant to maintain said implant in a collapsed state during delivery through a mammalian body lumen, and a coupling member for coupling portions of the sheet to one another to maintain said implant in said collapsed state.

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

3. The system of claim 1 wherein said sheet includes ends, side margins extending between said ends, and an eyelet disposed along each of said side margins.

4. The system of claim 3 wherein said eyelet is formed by a hole formed in said sheet.

5. The system of claim 3 including a loop coupled to said sheet, said loop forming said eyelet.

6. The system of claim 3 further including a reinforcing member, said reinforcing member being disposed between one of said eyelets and the outer perimeter of the side margin in which said eyelet is disposed.

7. The system of claim 1 wherein said coupling member comprises a thread adapted for threading through said eyelets.

8. The system of claim 7 wherein at least one of said side margins comprises overlapping portions of said sheet, said reinforcing member being positioned between said overlapping portions.

9. The system of claim 1 wherein said implant comprises a stent.

10. An assembly comprising a stent and a restraining member coupled to said stent, said stent having a collapsed and an expanded state, said restraining member comprising a sheet of material adapted to be wrapped around at least a portion of the stent when said stent is in said collapsed state, and portions of said sheet being adapted for coupling to one another to maintain said sheet wrapped around at least or portion of said stent in its collapsed state.

11. The assembly of claim 10 wherein said restraining member is fixedly secured to said stent.

12. The assembly of claim 10 wherein said restraining member is fixedly secured to said stent such that relative movement therebetween is substantially prevented.

13. The assembly of claim 10 wherein said sheet has a length, width and thickness, said width being less than the diameter of a portion of said stent when said stent is in said expanded state.

14. The assembly of claim 10 wherein said sheet has a width that is less than about 40 mm.

15. The assembly of claim 10 wherein the length of said restraining member, measured along the longitudinal axis thereof, is less than or equal to the length of said stent, measured along the longitudinal axis thereof.

16. The assembly of claim 10 further including a discrete member releasably coupling said portions to one another.

17. The assembly of claim 10 wherein said sheet includes ends and side margins extending between said ends, said side margins being releasably coupled to one another.

18. The assembly of claim 17 further including means for releasing the coupling between said side margins.

19. The assembly of claim 17 further including means for multidirectionally releasing the coupling between said side margins.

20. The assembly of claim 10 wherein said sheet includes ends, side margins extending between said ends, and at least one eyelet disposed along each of said side margins.

21. The assembly of claim 20 wherein said eyelet is formed by a hole formed in said sheet.

22. The assembly of claim 20 wherein said eyelet comprises a loop coupled to said sheet.

23. The assembly of claim 20 further including a member releasably coupling said eyelets to one another.

24. The assembly of claim 20 wherein each side margin includes multiple eyelets, said device further including a thread passing through said eyelets.

25. The assembly of claim 24 including multiple threads passing through said eyelets.

26. The assembly of claim 20 wherein each side margin includes multiple eyelets, said device further including a wire passing through said eyelets.

27. The assembly of claim 26 including multiple wires passing through said eyelets.

28. The assembly of claim 20 further including a reinforcing member, said reinforcing member being disposed between at least one of said eyelets and the outer perimeter of the side margin in which said eyelet is disposed.

29. The assembly of claim 28 wherein at least one of said side margins comprises overlapping portions of said sheet, said reinforcing member being positioned between said overlapping portions.

30. The assembly of claim 20 wherein the distance, measured along said sheet between said side margins, is less than the diameter of said stent when said stent is in said expanded state.

31. The assembly of claim 10 including multiple ones of said restraining member.

32. The assembly of claim 10 wherein said stent is generally cylindrical when in said expanded state.

33. The assembly of claim 10 wherein said stent has a bifurcated configuration when in said expanded state.

34. The assembly of claim 10 wherein said sheet of material is adapted for implantation within a human patient.

36. The assembly of claim 35 further including a discrete coupling member, said coupling member coupling said marginal side portions to one another.

37. The assembly of claim 35 wherein said sheet is arranged in generally tubular form to maintain said stent in said collapsed state.

38. The assembly of claim 35 wherein said sheet of material is adapted for implantation within a human patient.

40. The assembly of claim 39 wherein the relative circumferential position of said first and second stent portions changes when said stent moves between said collapsed to expanded state.

41. The assembly of claim 40 wherein the axial position of said first and second stent portions axially changes when said stent when said stent moves between said collapsed and expanded states.

35. An assembly comprising a stent and a sheet of material, said stent having a collapsed state and an expanded state, said stent being in said collapsed state and having said sheet of material wrapped around at least a portion thereof, said sheet having ends and marginal side portions extending between said ends, said marginal side portions being coupled to one another.

39. An assembly comprising a stent and a restraining member coupled to said stent, said stent having a collapsed and an expanded state, said stent having first and second portions that move relative to one another when said stent moves between said collapsed and expanded states, said restraining member comprising a sheet of material adapted to be wrapped around at least a portion of the stent when said stent is in said collapsed state, and portions of said sheet being adapted for coupling to one another to maintain said sheet wrapped around at least or portion of said stent in its collapsed state, said assembly further including a member having a first portion coupled to said restraining member and a second portion coupled to one of said stent first and second portions.

42. A method for delivering an expandable stent to a desired endolumenal site in a mammalian body comprising the steps of:

(a) positioning an expandable stent which is restrained in a collapsed state by a restraining member in a lumen having a wall,

(b) releasing said restraining member, and

(c) urging said restraining member into a position against said wall.

43. The method of claim 42 wherein the stent is a self-expanding stent and it is allowed to self-expand to urge the restraining member into a positions against said wall.

44. A method of preparing a stent for delivery to a desired site in a mammalian body comprising the steps of:

restraining a collapsed stent in a sheet of material having side margins; and

coupling said side margins to each other.

45. The method of claim 44 wherein said coupling step comprises coupling said side margins with multiple elements such that multiple portions of the coupling between said side margins may be released simultaneously.

47. The method of claim 46 wherein a portion of said stent is folded before step (a).

46. 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, and

(b) pulling the stent into a generally tubular restraining member.