Apparatus and methods for positioning prostheses for deployment from a catheter

• US 7,182,779 B2
• Filed: 07/02/2004
• Issued: 02/27/2007
• Est. Priority Date: 12/03/2001
• Status: Expired due to Term

• Current Assignee: JW Medical Systems Ltd
• Original Assignee: XTENT, Inc.
• Inventors: Andreas, Bernard, Welk, Craig, Acosta, Pablo, Snow, David, Landreville, Steve, Sanderson, David, Kao, Stephen, Lang, Eric, Karratt, Joe
• Primary Examiner(s): HO, TAN-UYEN THI
• Application Number:
  US10/884,616
• Publication Number:
  US 20050010276A1
• Time in Patent Office: 970 Days
• Field of Search: 623/1.11
• 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. Apparatus for delivering a prosthesis into a target vessel comprising:

a flexible catheter shaft having a proximal end and a distal end;

an expandable member coupled with the catheter shaft near the distal end movable from a contracted configuration to an expanded configuration;

a tubular prosthesis selectively movable in an axial direction over the expandable member; and

a stop member axially fixed relative to the member and disposed near the distal end for stopping the prosthesis at a deployment position on the expandable member, the tubular prosthesis being axially movable in a distal direction up to but not distally of the stop member.

2. The apparatus of claim 1, wherein the stop member has a first shape when the expandable member is in the contracted configuration and a second shape when the expandable member is in the expanded configuration.

3. The apparatus of claim 2, wherein the stop member is resiliently biased into the first shape, whereby the stop member recoils from the second shape to the first shape when the expandable member contracts from the expanded configuration to the contracted configuration.

4. The apparatus of claim 1, wherein the stop member is movable relative to the expandable member from a first position when the expandable member is in the contracted configuration to a second position when the expandable member is in the expanded configuration.

5. The apparatus of claim 4, wherein the stop member is resiliently biased into the first position, whereby the stop member recoils from the second position to the first position when the expandable member contracts from the expanded configuration to the contracted configuration.

6. The apparatus of claim 4, further comprising an actuator for selectively moving the stop member between the first and second positions.

7. The apparatus of claim 1, wherein the expandable member has a deployment portion and a tapered portion tapering distally from the deployment portion, the stop member being adapted to stop the tubular prosthesis on the deployment portion proximal to the tapered portion.

8. The apparatus of claim 7, wherein the tapered portion is everted within the deployment portion in the contracted configuration.

9. The apparatus of claim 1, wherein the expandable member has a proximal end mounted at a first mounting point on the catheter shaft and a distal end mounted at a second mounting point that is movable relative to the first mounting point.

10. The apparatus of claim 9, wherein the first mounting point and the second mounting point are interconnected by a shaft, the shaft having an elongatable section which elongates upon expansion of the expandable member.

11. The apparatus of claim 1, further comprising a pusher slidably disposed over the catheter shaft and engaging the tubular prosthesis for positioning the tubular prosthesis over the expandable member.

12. The apparatus of claim 1, further comprising a sheath slidably disposed over the catheter shaft and the tubular prosthesis and being axially movable relative thereto.

13. The apparatus of claim 12, wherein the prosthesis self-expands to a shape suitable for engaging the target vessel when the sheath is retracted to expose the prosthesis.

14. The apparatus of claim 12, wherein the sheath is axially positionable relative to the expandable member and configured to restrain expansion of a selected portion of the expandable member.

15. The apparatus of claim 14, wherein the sheath is reinforced to prevent expansion thereof by the expandable member.

16. The apparatus of claim 12, wherein the tubular prosthesis comprises a plurality of prosthesis segments.

17. The apparatus of claim 16, wherein the sheath is axially movable relative to the prosthesis segments and configured to restrain expansion of a selectable number of prosthesis segments.

18. The apparatus of claim 1, wherein the stop member is external to the expandable member.

19. The apparatus of claim 1, wherein the stop member is within the expandable member.

20. The apparatus of claim 1, wherein the stop member is fixed to the expandable member.

21. The apparatus of claim 1, wherein the stop member comprises a sleeve having a proximal portion disposed over a distal end of the expandable member.

22. The apparatus of claim 21, wherein the sleeve has a compressible portion, wherein expanding the expandable member compresses the compressible portion thereby moving the proximal portion relative to the expandable member.

23. The apparatus of claim 1, wherein the stop member comprises a cone shaped member disposed over a tapered distal end of the expandable member.

24. The apparatus of claim 23, wherein the cone-shaped member is movable between a contracted shape and an expanded shape upon expansion of the expandable member.

25. The apparatus of claim 1, wherein the stop member comprises a tubular member disposed distally of the expandable member.

26. The apparatus of claim 1, wherein a distal end of the expandable member is everted such that when the expandable member is inflated the everted portion becomes a tapered portion.

27. The apparatus of claim 26, wherein the distal end of the expandable member is coupled to an elongatable shaft such that expanding the expandable member elongates the shaft.

28. The apparatus of claim 1, wherein the stop member comprises a cone shaped member coupled with the catheter shaft inside the expandable member.

29. The apparatus of claim 1, wherein the at least one stop member comprises:

a movable distal nose cone slidably disposed over the distal end of the catheter shaft from a first position over a distal end of the expandable member to a second position distal to the distal end of the expandable member; and

an inner shaft slidably coupled to the catheter shaft and attached to the nose cone.

30. The apparatus of claim 1, further comprising a nosecone disposed distally of the expandable member, wherein the stop member comprises a sleeve extending proximally from the nose cone to cover a distal end of the expandable member.

31. The apparatus of claim 30, wherein the sleeve is biased to position a proximal end of the sleeve between the expandable member and a sheath of the apparatus.

32. The apparatus of claim 31, wherein sleeve includes at least one flexible bend along its length to bias the sleeve.

33. The apparatus of claim 1, further comprising a nosecone disposed distally of the expandable member, wherein the stop member comprises a plurality of projections extending proximally from the nose cone to cover a distal end of the expandable member.

34. The apparatus of claim 33, wherein at least a proximal portion of each projection is sufficiently resilient to expand with expansion of the expandable member and contract when the expandable member is deflated.

35. The apparatus of claim 34, further comprising an inner sleeve disposed within a distal portion of the stop member, over the expandable member, to prevent expansion of a distal tapered portion of the expandable member.

36. The apparatus of claim 1, wherein the at least one stop member comprises one or more surface features on a distal portion of the expandable member.

37. The apparatus of claim 36, wherein the surface features are selected from the group consisting of bumps, ridges, spines, ribs, scales, pleats and wings.

38. The apparatus of claim 36, wherein the surface feature comprises a thickened distal portion of the expandable member, the thickened distal portion including a proximal abutment.

39. The apparatus of claim 36, wherein the surface features comprise at least one material selected from the group consisting of Dacron, C-flex, high friction materials, gels and adhesives.

40. Apparatus for delivering a prosthesis into a target vessel comprising:

a flexible catheter shaft having a proximal end and a distal end;

a plurality of separate tubular prostheses directly adjacent to each other and slidably disposed over the catheter shaft;

a sheath disposed over the catheter shaft and the tubular prostheses and being axially movable relative thereto; and

a stop member coupled with the catheter shaft near the distal end for stopping at least one of the tubular prostheses at a deployment position along the catheter shaft, the tubular prostheses being axially movable in a distal direction up to but not distally of the stop member.

41. The apparatus of claim 40, further comprising a pusher axially movable relative to the catheter shaft and being in engagement with at least one tubular prosthesis for positioning the tubular prosthesis over the expandable member.

42. The apparatus of claim 40, wherein the tubular prostheses self-expand upon being exposed out of the sheath.

43. The apparatus of claim 40, further comprising an expandable member coupled with the catheter shaft near the distal end movable from a contracted configuration to an expanded configuration.

44. The apparatus of claim 43, wherein the stop member has a first shape when the expandable member is in the contracted configuration and a second shape when the expandable member is in the expanded configuration.

45. The apparatus of claim 44, wherein the stop member is resiliently biased into the first shape, whereby the stop member recoils from the second shape to the first shape when the expandable member contracts from the expanded configuration to the contracted configuration.

46. The apparatus of claim 43, wherein the stop member is movable relative to the expandable member from a first position when the expandable member is in the contracted configuration to a second position when the expandable member is in the expanded configuration.

47. The apparatus of claim 46, wherein the stop member is resiliently biased into the first position, whereby the stop member recoils from the second position to the first position when the expandable member contracts from the expanded configuration to the contracted configuration.

48. The apparatus of claim 46, further comprising an actuator for selectively moving the stop member between the first and second positions.

49. The apparatus of claim 43, wherein the expandable member has a deployment portion and a tapered portion tapering distally from the deployment portion, the stop member being adapted to stop the tubular prosthesis on the deployment portion proximal to the tapered portion.

50. The apparatus of claim 49, wherein the tapered portion is everted within the deployment portion in the contracted configuration.

51. The apparatus of claim 43, wherein the expandable member has a proximal end mounted at a first mounting point on the catheter shaft and a distal end mounted at a second mounting point that is movable relative to the first mounting point.

52. The apparatus of claim 51, wherein the first mounting point and the second mounting point are interconnected by a shaft, the shaft having an elongatable section which elongates upon expansion of the expandable member.

53. The apparatus of claim 43, wherein the stop member is external to the expandable member.

54. The apparatus of claim 43, wherein the stop member is within the expandable member.

55. The apparatus of claim 43, wherein the stop member is fixed to the expandable member.

56. The apparatus of claim 43, wherein the at least one stop member comprises:

a movable distal nose cone slidably disposed over the distal end of the catheter shaft from a first position over a distal end of the expandable member to a second position distal to the distal end of the expandable member; and

an inner shaft slidably coupled to the catheter shaft and attached to the nose cone.

57. The apparatus of claim 43, further comprising a nosecone disposed distally of the expandable member, wherein the stop member comprises a sleeve extending proximally from the nose cone to cover a distal end of the expandable member.

58. The apparatus of claim 57, wherein the sleeve is biased to position a proximal end of the sleeve between the expandable member and a sheath of the apparatus.

59. The apparatus of claim 58, wherein sleeve includes at least one flexible bend along its length to bias the sleeve.

60. The apparatus of claim 43, wherein the at least one stop member comprises one or more surface features on a distal portion of the expandable member.

61. The apparatus of claim 60, wherein the surface features are selected from the group consisting of bumps, ridges, spines, ribs, scales, pleats and wings.

62. The apparatus of claim 60, wherein the surface feature comprises a thickened distal portion of the expandable member, the thickened distal portion including a proximal abutment.

63. The apparatus of claim 60, wherein the surface features comprise at least one material selected from the group consisting of Dacron, C-flex, high friction materials, gels and adhesives.

64. Apparatus for delivering a prosthesis into a target vessel comprising:

a flexible catheter shaft having a proximal end, a distal end and at least one lumen;

an expandable member coupled with the catheter shaft near the distal end, the expandable member having a deployment portion and a tapered portion tapering distally from the deployment portion;

a tubular prosthesis slidably disposed over the catheter shaft and axially slidable over the expandable member;

a sheath slidably disposed over the expandable member and the tubular prosthesis and being axially movable relative thereto; and

an actuator for moving the expandable member a set distance relative to the sheath from a retracted position in which the tubular prosthesis is over the tapered portion to an extended position in which the tubular prosthesis is disposed over and in contact with the deployment portion.

65. Apparatus as in claim 64, wherein the actuator is disposed on a handle at the proximal end of the catheter shaft for advancing the expandable member by the set distance.

66. Apparatus as in claim 64, wherein the actuator comprises a compressible spring member associated with an element selected from the sheath, the catheter shaft, or the expandable member, wherein retracting the expandable member compresses the spring member and releasing the expandable member causes the spring member to recoil, thus moving the expandable member by the set distance.

67. A method of delivering a prosthesis in a target vessel of a patient comprising:

advancing a tubular prosthesis along a delivery catheter having an expandable member;

stopping the prosthesis at a deployment location on the expandable member with a stop member, the stop member being axially fixed relative to the expandable member; and

expanding the expandable member to expand at least part of the tubular prosthesis into engagement with the target vessel.

68. The method of claim 67, wherein the tubular prosthesis comprises a plurality of prosthesis segments, and wherein advancing the tubular prosthesis comprises positioning a first selected number of the prosthesis segments on an expandable member of the delivery catheter for expansion therewith.

69. The method of claim 68, further comprising positioning a sheath of the delivery catheter to expose the first selected number of prosthesis segments and to constrain expansion of a second selected number of the prosthesis segments.

70. The method of claim 69, further comprising covering a proximal portion of the expandable member by the sheath to constrain the proximal portion from expansion while a distal portion of the expandable member expands.

71. The method of claim 69, wherein expanding at least part of the tubular prosthesis comprises exposing the first selected number of prosthesis segments by positioning the sheath, to allow the first selected number of segments to self-expand.

72. The method of claim 67, wherein advancing the tubular prosthesis comprises pushing the prosthesis using a pusher of the delivery catheter.

73. The method of claim 67, wherein stopping the tubular prosthesis with the stop member comprises abutting the distal end of the prosthesis against the stop member.

74. The method of claim 67, wherein stopping the tubular prosthesis with the stop member comprises advancing a distal end portion of the tubular prosthesis over the stop member.

75. The method of claim 67, wherein expanding the tubular prosthesis comprises expanding an expandable member on the delivery catheter.

76. The method of claim 75, wherein the stop member expands with the expandable member.

77. The method of claim 75, wherein the stop member moves from a first position to a second position as the expandable member expands.

78. The method of claim 77, further comprising retracting the expandable member after the tubular prosthesis is expanded, wherein the stop member recoils to the first position when the expandable member is contracted.

79. The method of claim 75, further comprising moving the stop member from a first position to a second position relative to the expandable member after stopping the tubular prosthesis.

80. A method of delivering a prosthesis in a target vessel of a patient comprising:

advancing a plurality of prostheses along a delivery catheter having an expandable member;

and

stopping a first selected number of the prostheses at a deployment location on the delivery catheter with a stop member thereon, the stop member being axially fixed relative to the expandable;

and

expanding the expandable member to expand the first selected number of prostheses into engagement with the target vessel.

81. The method of claim 80, wherein advancing the tubular prosthesis comprises positioning the first selected number of the prostheses on an expandable member for expansion therewith.

82. The method of claim 81, further comprising positioning a sheath of the delivery catheter to expose the first selected number of prostheses and to constrain expansion of a second selected number of the prostheses.

84. The method of claim 82, wherein the first selected number of tubular prostheses self-expand when the sheath is retracted.

85. The method of claim 80, wherein the tubular prostheses are self-expanding, the method further comprising positioning a sheath of the delivery catheter to expose the first selected number of prosthesis segments and to constrain expansion of a second selected number of the prosthesis segments.

86. The method of claim 80, further comprising, after the expanding step:

advancing a second selected number of prostheses along the delivery catheter;

stopping the second selected number of prostheses with the stop member; and

expanding the second selected number of prostheses into engagement with the target vessel.

87. The method of claim 86, wherein the first and second selected number of prostheses are expanded by expanding an expandable member of the delivery catheter.

88. The method of claim 86, wherein the first and second selected number of prostheses are self-expanding.

89. The method of claim 86, wherein advancing the tubular prosthesis comprises pushing the prosthesis using a pusher of the delivery catheter.

90. The method of claim 80, wherein expanding the first selected number of prostheses comprises expanding an expandable member on the delivery catheter.

91. The method of claim 90, wherein the stop member expands with the expandable member.

92. The method of claim 90, wherein the stop member moves from a first position to a second position as the expandable member expands.

93. The method of claim 92, further comprising retracting the expandable member after the tubular prosthesis is expanded, wherein the stop member recoils to the first position when the expandable member is contracted.

94. The method of claim 90, further comprising moving the stop member from a first position to a second position relative to the expandable member after stopping the tubular prosthesis.

83. A method of delivering a prosthesis in a target vessel of a patient comprising:

advancing a plurality of prostheses along a delivery catheter, wherein advancing the plurality of prostheses comprises positioning a first selected number of the prostheses on an expandable member for expansion therewith;

stopping the first selected number of the prostheses at a deployment location on the delivery catheter with a stop member thereon;

positioning a sheath of the delivery catheter to expose the first selected number of prostheses and to constrain expansion of a second selected number of the prostheses;

covering a proximal portion of the expandable member by the sheath to constrain the proximal portion from expansion while a distal portion of the expandable member expands; and

expanding the first selected number of prostheses into engagement with the target vessel.

95. Apparatus for delivering a prosthesis into a target vessel comprising:

a flexible catheter shaft having a proximal end and a distal end;

an expandable member coupled with the catheter shaft near the distal end movable from a contracted configuration to an expanded configuration and wherein at least a portion of the expandable member is covered by an outer sheath;

a tubular prosthesis selectively movable in an axial direction over and in contact with the expandable member; and

a stop member disposed on the catheter shaft near the distal end for stopping the prosthesis at a deployment position on the expandable member.

96. Apparatus for delivering a prosthesis into a target vessel comprising:

a flexible catheter shaft having a proximal end and a distal end;

an expandable member coupled with the catheter shaft near the distal end movable from a contracted configuration to an expanded configuration and wherein at least a portion of the expandable member is covered by an outer sheath;

a tubular prosthesis selectively movable in an axial direction over the expandable member;

a pusher for moving the tubular prosthesis, wherein the pusher is movable relative to the tubular prosthesis; and

a stop member disposed on the catheter shaft near the distal end for stopping the prosthesis at a deployment position on the expandable member.