Apparatus and methods for positioning prostheses for deployment from a catheter

• US 8,083,788 B2
• Filed: 11/28/2006
• Issued: 12/27/2011
• Est. Priority Date: 12/03/2001
• Status: Active Grant

• Current Assignee: JW Medical Systems Ltd
• Original Assignee: XTENT, Inc.
• Inventors: Acosta, Pablo, Andreas, Bernard, Kao, Stephen, Karratt, Joe, Landreville, Steve, Lang, Eric, Sanderson, David, Welk, Craig, Snow, David W.
• Primary Examiner(s): Troung, Kevin T
• Application Number:
  US11/563,793
• Publication Number:
  US 20070100423A1
• Time in Patent Office: 1,855 Days
• Field of Search: 623/1.11, 623/1.12, 606191-198
• US Class Current: 623/1.11
• 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 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61F 2002/826 more than one stent being applied sequentially
• CPC Class Codes: A61F 2002/91508 the meander having a difference in amplitude along the band
• CPC Class Codes: A61F 2002/91516 the meander having a change in frequency along the band
• CPC Class Codes: A61F 2002/91525 within the whole structure different bands showing different meander characteristics, e.g. frequency or amplitude
• CPC Class Codes: A61F 2002/91533 characterised by the phase between adjacent bands
• CPC Class Codes: A61F 2002/9155 Adjacent bands being connected to each other
• CPC Class Codes: A61F 2002/91558 connected peak to peak
• CPC Class Codes: A61F 2002/9583 Means for holding the stent on the balloon, e.g. using protrusions, adhesives or an outer sleeve
• CPC Class Codes: A61F 2230/0013 Horseshoe-shaped, e.g. crescent-shaped, C-shaped, U-shaped

Abstract

Apparatus for delivering stents to body lumens include a flexible catheter shaft, an expandable member, a tubular prosthesis selectively movable in an axial direction over the expandable member, and a stop member disposed on the catheter shaft near the distal end of the catheter shaft for stopping the prosthesis at a deployment position on the expandable member. A variety of different stop members are provided according to various embodiments, such as stop members disposed outside the expandable member, stop members disposed inside the expandable member, movable stop members, and the like. Methods of delivering stents are also provided.

Claims

1. An apparatus for delivering a prosthesis into a target vessel of a patient'"'"'s body, said apparatus comprising:

a flexible catheter shaft having a distal end disposed in the target vessel and a proximal end disposed outside the body;

an expandable member disposed near the distal end of the catheter shaft, the expandable member being movable from a contracted configuration to an expanded configuration;

a tubular prosthesis axially positionable over and in contact with the expandable member, the prosthesis having an unexpanded configuration and being radially expandable to a deployed configuration for deployment in the target vessel, wherein the unexpanded tubular prosthesis is slidably disposed on the catheter shaft near the distal end of the catheter, and wherein the unexpanded prosthesis is selectively movable in an axial direction over the expandable member with a mechanism controllable from the proximal end of the catheter shaft; and

a stop member axially fixed relative to the catheter shaft near the distal end thereof, wherein the stop member inhibits axial displacement of the prosthesis distally of a deployment position along the expandable member when the prosthesis is in the unexpanded configuration, and wherein the prosthesis is expandable to the deployed configuration by the expandable member when disposed at the deployment position.

2. The apparatus of claim 1, wherein the stop member is attached to the catheter shaft.

3. The apparatus of claim 2, wherein the stop member comprises an annular structure around the catheter shaft.

4. The apparatus of claim 1, wherein the stop member is disposed outside of the expandable member.

5. The apparatus of claim 1, wherein the expandable member is disposed over the stop member.

6. The apparatus of claim 5, wherein the expandable member is attached to the stop member.

7. The apparatus of claim 1, wherein the stop member is disposed on a surface of expandable member.

8. The apparatus of claim 7, wherein the stop member comprises at least one surface feature on the expandable member configured to engage the prosthesis.

9. The apparatus of claim 1, further comprising a nosecone attached to the distal end of the catheter shaft, the stop member being attached to the nosecone.

10. The apparatus of claim 1, wherein the expandable member comprises a working portion having a generally constant outer diameter in the expanded configuration, and wherein the stop member is positioned to inhibit displacement of the tubular prosthesis distally of the working portion.

11. The apparatus of claim 10, wherein the expandable member further comprises a distal leg coupled to the catheter shaft and a distal taper which connects the working portion to the distal leg, the distal taper having, in the expanded configuration, a diameter which decreases between the working portion and the distal leg, and wherein the stop member is positioned to keep the prosthesis proximal to the distal taper.

12. The apparatus of claim 1, wherein the stop member imparts friction to an inner surface of the prosthesis.

13. The apparatus of claim 1, wherein the stop member has an abutment that engages a distal end of the prosthesis.

14. The apparatus of claim 1, wherein the mechanism comprises a pusher slidably coupled to the catheter shaft and adapted to move the prosthesis relative to the expandable member.

15. The apparatus of claim 1, wherein the mechanism comprises a retractable sheath, the prosthesis comprises at least one stent segment, and the sheath comprises a distal-most portion reinforced to resist radial expansion so as to prevent expansion of the prosthesis while allowing at least a distal portion of the expandable member to be expanded without expanding the prosthesis.

16. The apparatus of claim 15, wherein the length of the distal portion of the expandable member is selectively changeable from the proximal end of the catheter shaft.

17. The apparatus of claim 15, wherein the mechanism is operably coupled to the prosthesis so as to move the prosthesis onto the distal portion of the expandable member.

18. The apparatus of claim 17, wherein the mechanism for moving the prosthesis onto the expandable member comprises a pusher slidably coupled to the catheter shaft.

19. The apparatus of claim 15, wherein the mechanism is coupleable with the prosthesis so as to move the prosthesis off the distal portion of the expandable member.

20. The apparatus of claim 1, wherein the mechanism for moving the prosthesis off the distal portion of the expandable member comprises a retractable sheath slidably coupled to the catheter shaft and covering the expandable member and prosthesis.

21. The apparatus of claim 20, wherein the sheath has a separation member that engages the prosthesis such that the prosthesis is retractable in conjunction with the sheath.

22. The apparatus of claim 1, further comprising an additional quantity of tubular prostheses positionable over and in contact with the expandable member, each of the additional quantity of prostheses having an unexpanded configuration and being radially expandable to a deployed configuration for deployment in the target vessel.

23. The apparatus of claim 22, wherein at least a first prosthesis is positionable on the expandable member for expansion therewith while at least a second prosthesis is maintained in the unexpanded configuration.

24. The apparatus of claim 23, further comprising a mechanism controllable from the proximal end of the catheter shaft for selectively changing the number of prostheses that are positioned for expansion by the expandable member.

25. The apparatus of claim 24, wherein the mechanism for selectively changing the number of prostheses comprises a retractable sheath slidably coupled to the catheter shaft and covering the prostheses and expandable member.

26. The apparatus of claim 25, wherein the sheath is adapted to retract a selectable number of the prostheses proximally relative to the expandable member.

27. The apparatus of claim 25, wherein the sheath is adapted to expose a selectable number of the prostheses distally of the sheath for expansion with the expandable member.

28. The apparatus of claim 25, wherein the sheath is adapted to constrain expansion of a proximal portion of the expandable member and the prostheses disposed thereon which are covered by the sheath.

29. The apparatus of claim 25, further comprising a separation member on the sheath adapted to engage at least one prosthesis such that it is retractable in conjunction with the sheath.

30. The apparatus of claim 24, wherein the mechanism for selectively changing the number of prostheses comprises a pusher slidably coupled to the catheter shaft and adapted to apply a distally directed force to the prostheses.

31. An apparatus for delivering a prosthesis into a target vessel of a patient'"'"'s body, said apparatus comprising:

a flexible catheter shaft having a distal end disposed in the target vessel and a proximal end disposed outside the body;

an expandable member disposed at the distal end of the catheter, the expandable member being movable from a contracted configuration to an expanded configuration;

a tubular prosthesis axially positionable over and in contact with the expandable member, the prosthesis having an unexpanded configuration and being radially expandable to a deployed configuration for deployment in the target vessel, wherein the unexpanded tubular prosthesis is slidably disposed on the catheter shaft near the distal end of the catheter shaft, and wherein the unexpanded prosthesis is selectively movable in an axial direction over the expandable member;

a mechanism controllable from the proximal end of the catheter shaft for selectively moving the unexpanded prosthesis in an axial direction over the expandable member; and

a stop member axially fixed relative to the catheter shaft near the distal end thereof, wherein the stop member inhibits axial displacement of the prosthesis distally of a deployment position along the expandable member when the prosthesis is in the unexpanded configuration and wherein the prosthesis is expandable to the deployed configuration by the expandable member when disposed at the deployment position; and

wherein the prosthesis is expandable to the deployed configuration by the expandable member when disposed at the deployment position.

32. The apparatus of claim 31, wherein the stop member is attached to the catheter shaft.

33. The apparatus of claim 32, wherein the stop member comprises an annular structure around the catheter shaft.

34. The apparatus of claim 31, wherein the stop member is disposed outside of the expandable member.

35. The apparatus of claim 31, wherein the expandable member is disposed over the stop member.

36. The apparatus of claim 35, wherein the expandable member is attached to the stop member.

37. The apparatus of claim 31, wherein the stop member is disposed on a surface of the expandable member.

38. The apparatus of claim 37, wherein the stop member comprises at least one surface feature on the expandable member configured to engage the prosthesis.

39. The apparatus of claim 31, further comprising a nosecone attached to the distal end of the catheter shaft, the stop member being attached to the nosecone.

40. The apparatus of claim 31, wherein the expandable member comprises a working portion having a generally constant outer diameter in the expanded configuration, and wherein the stop member is positioned to inhibit displacement of the tubular prosthesis distally of the working portion.

41. The apparatus of claim 40, wherein the expandable member further comprises a distal leg coupled to the catheter shaft and a distal taper which connects the working portion to the distal leg, the distal taper having, in the expanded configuration, a diameter which decreases between the working portion and the distal leg, and wherein the stop member is positioned to keep the prosthesis proximal to the distal taper.

42. The apparatus of claim 31, wherein the stop member imparts friction to an inner surface of the prosthesis.

43. The apparatus of claim 31, wherein the stop member has an abutment that engages a distal end of the prosthesis.

44. The apparatus of claim 31, wherein the mechanism comprises a pusher slidably coupled to the catheter shaft and adapted to move the prosthesis relative to the expandable member.

45. The apparatus of claim 31, wherein the length of the distal portion of the expandable member is selectively changeable from the proximal end of the catheter shaft.

46. The apparatus of claim 31, wherein the mechanism is coupleable with the prosthesis so as to move the prosthesis onto the distal portion of the expandable member.

47. The apparatus of claim 46, wherein the mechanism for moving the prosthesis onto the expandable member comprises a pusher slidably coupled to the catheter shaft.

48. The apparatus of claim 31, wherein the mechanism is coupleable with the prosthesis so as to move the prosthesis off the distal portion of the expandable member.

49. The apparatus of claim 48, wherein the mechanism for moving the prosthesis off the distal portion of the expandable member comprises a retractable sheath slidably coupled to the catheter shaft and covering the expandable member and prosthesis.

50. The apparatus of claim 49, wherein the sheath has a separation member that engages the prosthesis such that the prosthesis is retractable in conjunction with the sheath.

51. The apparatus of claim 31, further comprising an additional quantity of tubular prostheses positionable over and in contact with the expandable member, each of the additional quantity of prostheses having an unexpanded configuration and being radially expandable to a deployed configuration for deployment in the target vessel.

52. The apparatus of claim 51, wherein at least a first prosthesis is positionable on the expandable member for expansion therewith while at least a second prosthesis is maintained in the unexpanded configuration.

53. The apparatus of claim 52, further comprising a mechanism controllable from the proximal end of the catheter shaft for selectively changing the number of prostheses that are positioned for expansion by the expandable member.

54. The apparatus of claim 53, wherein the mechanism for selectively changing the number of prostheses comprises a retractable sheath slidably coupled to the catheter shaft and covering the prostheses and expandable member.

55. The apparatus of claim 54, wherein the sheath is adapted to retract a selectable number of the prostheses proximally relative to the expandable member.

56. The apparatus of claim 54, wherein the sheath is adapted to expose a selectable number of the prostheses distally of the sheath for expansion with the expandable member.

57. The apparatus of claim 54, wherein the sheath comprises a reinforced distal-most portion adapted to resist radial expansion so as to constrain expansion of a proximal portion of the expandable member and the prostheses disposed thereon which are covered by the sheath.

58. The apparatus of claim 54, further comprising a separation member on the sheath adapted to engage at least one prosthesis such that it is retractable in conjunction with the sheath.

59. The apparatus of claim 53, wherein the mechanism for selectively changing the number of prostheses comprises a pusher slidably coupled to the catheter shaft and adapted to apply a distally directed force to the prostheses.