Methods and apparatus for endovascularly replacing a heart valve

• US 20050143809A1
• Filed: 11/05/2004
• Published: 06/30/2005
• Est. Priority Date: 12/23/2003
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Sadra Medical
• Inventors: Hildebrant, Daniel, Valencia, Hans F., Morejohn, Dwight P., Argento, Claudio, Haug, Ulrich R., Brandt, Brian D., Salahieh, Amr, Dueri, Jean-Pierre, Saul, Tom
• Granted Patent: US 7,959,666 B2
• Time in Patent Office: Days
• US Class Current: 623/2.110
• CPC Class Codes: A61F 2/2409 Support rings therefor, e.g. for connecting valves to tissue annuloplasty rings A61F2/2442
• CPC Class Codes: A61F 2/2412 with soft flexible valve members, e.g. tissue valves shaped like natural valves check valves with flexible valve members in general F16K15/14
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/243 Deployment by mechanical expansion
• CPC Class Codes: A61F 2/2433 using balloon catheter
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/2439 Expansion controlled by filaments
• CPC Class Codes: A61F 2/90 characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2002/9528 for retrieval of stents
• 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 2220/0058 soldered or brazed or welded
• CPC Class Codes: A61F 2230/005 Rosette-shaped, e.g. star-shaped
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2230/0078 hyperboloidal
• CPC Class Codes: A61F 2230/008 paraboloidal
• CPC Class Codes: A61F 2250/006 modular

Abstract

The invention includes methods of and apparatus for endovascularly replacing a heart valve of a patient. One aspect of the invention provides a method including the steps of endovascularly delivering a replacement valve and an expandable anchor to a vicinity of the heart valve in an unexpanded configuration; and applying an external non-hydraulically expanding or non-pneumatically expanding actuation force on the anchor to change the shape of the anchor, such as by applying proximally and/or distally directed force on the anchor using a releasable deployment tool to expand and contract the anchor or parts of the anchor. Another aspect of the invention provides an apparatus including a replacement valve; an anchor; and a deployment tool comprising a plurality of anchor actuation elements adapted to apply a non-hydraulically expanding or non-pneumatically expanding actuation force on the anchor to reshape the anchor.

Claims

1. Apparatus for endovascularly replacing a patient'"'"'s heart valve comprising:

a replacement valve;

an anchor; and

a deployment tool comprising a plurality of anchor actuation elements adapted to apply a non-hydraulically expanding or non-pneumatically expanding actuation force on the anchor to reshape the anchor.

2. The apparatus of claim 1 wherein the anchor actuation elements comprise a plurality of proximal anchor actuation elements adapted to apply an actuation force on a proximal portion of the anchor.

3. The apparatus of claim 1 wherein the anchor actuation elements comprise a plurality of distal anchor actuation elements adapted to apply an actuation force on a distal portion of the anchor.

4. The apparatus of claim 1 wherein the anchor actuation elements each comprise a first member attached to the anchor and a second member releasably attached to the first member.

5. The apparatus of claim 4 wherein the first members each comprise a post adapted to support the valve within the anchor.

6. The apparatus of claim 5 wherein at least one post comprises valve attachment structure, the replacement valve being attached to the post via the valve attachment structure.

7. The apparatus of claim 6 wherein the valve attachment structure comprises a plurality of holes formed in the post.

8. The apparatus of claim 7 wherein the valve attachment structure comprises a tab extending from the post.

9. The apparatus of claim 4 wherein the first members each comprise a lock element adapted to lock the anchor in a deployed shape.

10. The apparatus of claim 9 wherein the lock element is further adapted to engage an anchor element to lock the anchor in the deployed shape.

11. The apparatus of claim 9 wherein the apparatus further comprises anchor lock elements attached to the anchor and adapted to mate with the lock element of each first member to lock the anchor in the deployed shape.

12. The apparatus of claim 11 wherein the anchor lock elements each comprise a camming surface adapted to engage the first member and to move at least a portion of the anchor lock element in response to a lock actuation force.

13. The apparatus of claim 11 further comprising a lock actuator adapted to apply a locking force to move at least a portion of the anchor lock element.

14. The apparatus of claim 11 wherein at least one first member lock element and at least one anchor lock element are adapted to mate at a plurality of mating configurations.

15. The apparatus of claim 14 wherein the at least one first member lock element comprises a plurality of ratchets adapted to engage a tooth portion of the at least one anchor lock element.

16. The apparatus of claim 15 wherein the at least one first member further comprises valve support structure, at least a portion of the plurality of ratchets being disposed distal to the valve support structure.

17. The apparatus of claim 15 wherein the at least one first member further comprises valve support structure, at least a portion of the plurality of ratchets being disposed neither distal to nor proximal to the valve support structure.

18. The apparatus of claim 15 wherein the at least one first member further comprises valve support structure, substantially all of the plurality of ratchets being disposed proximal to the valve support structure.

19. The apparatus of claim 11 wherein the anchor lock elements each comprise a buckle.

20. The apparatus of claim 19 wherein the buckle is formed from a cut tube.

21. The apparatus of claim 19 wherein the buckle is formed from bent resilient material.

22. The apparatus of claim 11 wherein the first member lock element further comprises a lock alignment feature adapted to align the first member lock element with the anchor lock element.

23. The apparatus of claim 22 wherein the lock alignment feature comprises a hinge.

24. The apparatus of claim 22 wherein the lock alignment feature comprises an engagement portion of the anchor lock element adapted to engage the first member before engagement of the anchor lock element with the first member lock element.

25. The apparatus of claim 22 wherein the first member lock element and the anchor lock element define a lock width, the lock alignment feature comprising a first member lock element lock area substantially wider than the lock width.

26. The apparatus of claim 9 further comprising a lock actuator adapted to apply a locking force to lock the anchor in the deployed shape.

27. The apparatus of claim 26 wherein the distal anchor actuation element comprises the lock actuator.

28. The apparatus of claim 26 further comprising an unlocking actuator adapted to unlock the anchor.

29. The apparatus of claim 28 wherein the lock actuator comprises the unlocking actuator.

30. The apparatus of claim 28 wherein the unlocking actuator comprises a proximal pull actuator.

31. The apparatus of claim 28 wherein the unlocking actuator comprises a distal push actuator.

32. The apparatus of claim 26 further comprising a lock prevention mechanism.

33. The apparatus of claim 9 wherein the first members each comprise a spring adapted to permit axial lengthening of the anchor in response to radially inward compression.

34. The apparatus of claim 1 wherein the anchor actuation elements are adapted to apply a distally directed force on the anchor.

35. The apparatus of claim 1 wherein the anchor actuation elements are adapted to apply a proximally directed force on the anchor.

36. The apparatus of claim 1 wherein the anchor actuation elements are adapted to apply distally directed and proximally directed forces on the anchor.

37. The apparatus of claim 1 further comprising a releasable attachment mechanism adapted to releasably attach at least one anchor actuation element to the anchor.

38. The apparatus of claim 37 further comprising a movable release actuator adapted to actuate the releasable attachment mechanism.

39. The apparatus of claim 38 wherein the movable release actuator is adapted to prevent a release movement of the anchor attachment mechanism in a first position and to permit a release movement of the anchor attachment mechanism in a second position.

40. The apparatus of claim 39 wherein the release actuator comprises a cover covering at least a portion of the releasable attachment mechanism.

41. The apparatus of claim 38 wherein the release actuator comprises an elongated element movable within at least part of the releasable attachment mechanism.

42. The apparatus of claim 41 wherein the release actuator further comprises a camming surface adapted to resist actuation of the releasable attachment mechanism.

43. The apparatus of claim 41 wherein a distal portion of the elongated element is adapted to engage the anchor.

44. The apparatus of claim 38 wherein the release actuator comprises a friction surface.

45. The apparatus of claim 38 wherein the release actuator is adapted to move less than one inch to release the attachment mechanism.

46. The apparatus of claim 37 wherein the releasable attachment mechanism comprises a wrap portion adapted to wrap at least part way around an anchor element.

47. The apparatus of claim 46 wherein at least the wrap portion comprises shape memory material.

48. The apparatus of claim 46 wherein the wrap portion comprises an opening adapted to engage a release actuator.

49. The apparatus of claim 48 wherein the opening comprises a first opening, the releasable attachment mechanisms each comprising a second opening adapted to be aligned with the first opening and to engage the release actuator.

50. The apparatus of claim 49 wherein the releasable attachment mechanisms each comprise a spring element adapted to urge the first opening out of alignment with the second opening.

51. The apparatus of claim 37 wherein the releasable attachment mechanism comprises a first shape on an anchor actuation element adapted to mate with a second shape on an anchor attachment element to substantially prevent relative distal or proximal movement between the anchor actuation element and the anchor.

52. The apparatus of claim 51 further comprising a release actuator adapted to actuate the releasable attachment mechanism.

53. The apparatus of claim 52 wherein the release actuator is adapted to be moved to permit relative movement between the first shape and the second shape.

54. The apparatus of claim 52 wherein the release actuator is adapted to be moved to permit the first shape to change to a third shape permitting relative distal or proximal movement between the anchor actuation element and the anchor.

55. The apparatus of claim 52 wherein the release actuator is adapted to be moved to permit the second shape to change to a third shape permitting relative distal or proximal movement between the anchor actuation element and the anchor.

56. The apparatus of claim 51 wherein the anchor actuation element is adapted to separate from the anchor attachment element in response to relative movement between the anchor actuation element and the anchor attachment element.

57. The apparatus of claim 56 wherein the first shape comprises a camming surface.

58. The apparatus of claim 56 wherein the second shape comprises a camming surface.

59. The apparatus of claim 1 wherein the anchor actuation elements each comprise a curved portion.

60. The apparatus of claim 59 wherein the curved portion of each anchor actuation element is at a distal end of the anchor actuation element.

61. The apparatus of claim 1 wherein the anchor actuation elements comprise shaping features adapted to affect a shape of the anchor actuation elements when an anchor actuation force is applied.

62. The apparatus of claim 61 wherein the shaping features comprise reduced diameter portions of the anchor actuation elements.

63. The apparatus of claim 61 wherein the shaping features comprise reduced wall thickness portions of the anchor actuation elements.

64. The apparatus of claim 61 wherein the shaping features comprise slits formed in the anchor actuation elements.

65. The apparatus of claim 1 wherein the anchor actuation elements comprise a plurality of arms extending from a unitary structure.

66. The apparatus of claim 65 wherein each arm is adapted to move radially outward and radially inward with respect to other arms as the anchor reshapes.

67. The apparatus of claim 65 wherein the anchor actuation elements comprise a cut tube.

68. The apparatus of claim 1 wherein the deployment tool further comprises a catheter adapted to percutaneously communicate the anchor actuation elements with an operator exterior to the patient.

69. The apparatus of claim 68 wherein the catheter comprises a plurality of lumens, at least part of each anchor actuation element being disposed in one of the lumens.

70. The apparatus of claim 68 wherein the deployment tool further comprises a handle adapted to actuate the anchor actuation elements.

71. The apparatus of claim 1 wherein the deployment tool is further adapted to apply a non-hydraulically expanding or non-pneumatically expanding actuation force on the anchor without passing any portion of the deployment tool through a central opening in the replacement valve.

72. A method for endovascularly replacing a heart valve of a patient, the method comprising:

endovascularly delivering a replacement valve and an expandable anchor to a vicinity of the heart valve in a delivery configuration; and

applying an external non-hydraulically expanding or non-pneumatically expanding force on the anchor through a plurality of anchor actuation elements to change the shape of the anchor.

73. The method of claim 72 wherein the applying step comprises applying the external non-hydraulically expanding or non-pneumatically expanding force on a proximal portion of the anchor through the anchor actuation elements to change the shape of the anchor.

74. The method of claim 73 wherein the applying step comprises applying a distally directed external non-hydraulically expanding or non-pneumatically expanding force on a proximal portion of the anchor through the anchor actuation elements to change the shape of the anchor.

75. The method of claim 74 wherein the applying step comprises moving the proximal portion of the anchor distally.

76. The method of claim 73 wherein the applying step comprises applying a proximally directed external non-hydraulically expanding or non-pneumatically expanding force on a proximal portion of the anchor through the anchor actuation elements to change the shape of the anchor.

77. The method of claim 72 wherein the applying step comprises applying the external non-hydraulically expanding or non-pneumatically expanding force on a distal portion of the anchor through the anchor actuation elements to change the shape of the anchor.

78. The method of claim 77 wherein the applying step comprises applying a proximally directed external non-hydraulically expanding or non-pneumatically expanding force on a distal portion of the anchor through the anchor actuation elements to change the shape of the anchor.

79. The method of claim 78 wherein the applying step comprises moving the distal portion of the anchor proximally.

80. The method of claim 72 further comprising locking the anchor in a deployed shape.

81. The method of claim 80 wherein the locking step comprises mating first and second anchor lock elements.

82. The method of claim 81 wherein the locking step further comprises engaging first and second lock element camming surfaces.

83. The method of claim 81 wherein the locking step further comprises moving at least a portion of the first lock element or the second lock element.

84. The method of claim 81 further comprising aligning the first and second lock elements prior to the locking step.

85. The method of claim 81 wherein the locking step comprises engaging the first and second lock elements at one of a plurality of locking locations along the first or the second lock elements.

86. The method of claim 80 wherein the locking step comprises operating a lock actuator.

87. The method of claim 80 further comprising unlocking the anchor.

88. The method of claim 87 wherein the unlocking step comprises operating an unlocking actuator.

89. The method of claim 72 further comprising releasing at least a portion of the anchor actuation elements from the anchor.

90. The method of claim 89 wherein the releasing step comprising operating a release actuator.

91. The method of claim 90 wherein the step of operating a release actuator comprises moving the release actuator proximally.

92. The method of claim 91 wherein the moving step comprises moving the release actuator less than one inch.

93. The method of claim 72 wherein the applying step comprises applying an external non-hydraulically expanding or non-pneumatically expanding force on the anchor without passing any portion of an anchor actuation element through a central opening of the replacement valve.