Methods and apparatus for endovascularly replacing a heart valve

• US 20050137699A1
• Filed: 11/05/2004
• Published: 06/23/2005
• Est. Priority Date: 12/23/2003
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Sadra Medical, Inc. (Boston Scientific Corporation)
• Inventors: Valencia, Hans F., Morejohn, Dwight P., Hildebrand, Daniel, Argento, Claudio, Haug, Ulrich R., Brandt, Brian D., Salahieh, Amr, Dueri, Jean-Pierre, Saul, Tom
• Granted Patent: US 7,824,442 B2
• Time in Patent Office: Days
• US Class Current: 623/2.110
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• 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 2002/9528 for retrieval of stents
• CPC Class Codes: A61F 2220/005 using adhesives
• CPC Class Codes: A61F 2220/0058 soldered or brazed or welded
• 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 in an unexpanded configuration within a sheath to a vicinity of the heart valve; deploying the anchor from the sheath; expanding the anchor with a deployment tool comprising a plurality of actuation elements to contact tissue at an anchor site; and retrieving the anchor into the sheath. Another aspect of the invention provides apparatus including a sheath; a deployment tool comprising a plurality of anchor actuation elements; a replacement valve configured to be disposed within the sheath for delivery to a vicinity of the heart valve; and an expandable anchor configured to be disposed within the sheath for delivery to the vicinity of the heart valve, to be deployed from the sheath, to be expanded by the deployment tool to contact tissue at an anchor site and to be retrieved back into the sheath after having been expanded.

Claims

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

a sheath;

a deployment tool comprising a plurality of anchor actuation elements;

a replacement valve configured to be disposed within the sheath for delivery to a vicinity of the heart valve; and

an expandable anchor configured to be disposed within the sheath for delivery to the vicinity of the heart valve, to be deployed from the sheath, to be expanded by the deployment tool to contact tissue at an anchor site and to be retrieved back into the sheath after having been expanded.

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 3 wherein the distal anchor actuation elements each comprises a first member attached to the distal portion of 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 35 wherein the anchor actuation elements are further adapted to retrieve the anchor into the sheath.

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

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

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

40. The apparatus of claim 39 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.

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

42. The apparatus of claim 39 wherein the release actuator comprises an elongated element movable within at least part of the attachment mechanism.

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

44. The apparatus of claim 42 wherein a distal portion of the elongated element is adapted to engage the anchor.

45. The apparatus of claim 39 wherein the release actuator comprises a friction surface.

46. The apparatus of claim 39 wherein the release actuator is adapted to move less than one inch to release the attachment mechanism.

47. The apparatus of claim 38 wherein the releasable attachment mechanism comprises a wrap portion adapted to wrap at least part way around an anchor element.

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

49. The apparatus of claim 47 wherein the wrap portion comprises an opening adapted to engage a release actuator.

50. The apparatus of claim 49 wherein the opening comprising 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.

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

52. The apparatus of claim 38 wherein the releasable attachment mechanisms each comprise 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.

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

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

55. The apparatus of claim 53 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.

56. The apparatus of claim 53 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.

57. The apparatus of claim 52 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.

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

59. The apparatus of claim 57 wherein the second shape comprises a camming surface.

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

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

62. 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.

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

64. The apparatus of claim 62 wherein the shaping features comprise reduced wall thickness portions of the anchor actuation elements.

65. The apparatus of claim 62 wherein the shaping features comprise slits formed in the anchor actuation elements.

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

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

68. The apparatus of claim 66 wherein the anchor actuation elements comprise a cut tube.

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

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

71. The apparatus of claim 69 wherein the deployment tool further comprises a handle adapted to actuate the anchor actuation elements.

72. The apparatus of claim 1 wherein the deployment tool is configured to expand the anchor without passing any portion of the deployment tool through a center opening of the replacement valve.

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

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

deploying the anchor from the sheath;

expanding the anchor with a deployment tool comprising a plurality of actuation elements to contact tissue at an anchor site; and

retrieving the anchor into the sheath.

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

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

77. The method of claim 74 wherein the applying step comprises applying a proximally directed force on a proximal portion of the anchor through the anchor actuation elements to change the shape of the anchor.

78. The method of claim 73 wherein the expanding step comprises applying a 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 applying a proximally directed force on a distal portion of the anchor through the anchor actuation elements to change the shape of the anchor.

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

81. The method of claim 73 further comprising locking the anchor in a deployed shape.

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

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

84. The method of claim 82 wherein the locking step further comprises moving at least a portion of the first lock element or the second lock element.

85. The method of claim 81 wherein the locking step comprises operating a lock actuator.

86. The method of claim 79 further comprising unlocking the anchor.

87. The method of claim 86 wherein the unlocking step comprises operating an unlocking actuator.

88. The method of claim 73 wherein the expanding step comprises expanding the anchor with the deployment tool without passing any portion of the deployment tool through a center opening of the replacement valve.