Everting heart valve

• US 20050283231A1
• Filed: 06/16/2004
• Published: 12/22/2005
• Est. Priority Date: 06/16/2004
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Original Assignee: Sadra Medical, Inc. (Boston Scientific Corporation)
• Inventors: Valencia, Hans F., Morejohn, Dwight P., Haug, Ulrich R., Geshlider, Robert A., Michlitsch, Kenneth J., Salahieh, Amr, Saul, Tom
• Granted Patent: US 7,780,725 B2
• Time in Patent Office: Days
• US Class Current: 623/2.11
• 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 2/2433 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 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2220/0033 made by longitudinally pushing a protrusion into a complementary-shaped recess, e.g. held by friction fit
• CPC Class Codes: A61F 2220/005 using adhesives
• CPC Class Codes: A61F 2220/0058 soldered or brazed or welded
• 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 2230/005 Rosette-shaped, e.g. star-shaped
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2230/0065 toroidal, e.g. ring-shaped, doughnut-shaped
• CPC Class Codes: A61F 2230/0078 hyperboloidal

Abstract

The present invention provides methods and apparatus for endovascularly replacing a patient'"'"'s heart valve. The apparatus includes a replacement valve and an expandable anchor configured for endovascular delivery to a vicinity of the patient'"'"'s heart valve. In some embodiments, the replacement valve is adapted to wrap about the anchor, for example, by everting during endovascular deployment. In some embodiments, the replacement valve is not connected to expandable portions of the anchor. In some embodiments, the anchor is configured for active foreshortening during endovascular deployment. In some embodiments, the anchor includes expandable lip and skirt regions for engaging the patient'"'"'s heart valve during deployment. In some embodiments, the anchor comprises a braid fabricated from a single strand of wire. In some embodiments, the apparatus includes a lock configured to maintain anchor expansion. The invention also includes methods for endovascularly replacing a patient'"'"'s heart valve. In some embodiments, the method includes the steps of endovascularly delivering a replacement valve and an expandable anchor to a vicinity of the heart valve, wrapping at least a portion of the replacement valve about the anchor, and expanding the anchor to a deployed configuration.

Claims

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

a replacement valve; and

an expandable anchor,

wherein the replacement valve and the expandable anchor are configured for endovascular delivery to a vicinity of the patient'"'"'s heart valve, and

wherein at least an everting portion of the replacement valve is configured to evert about the anchor during endovascular deployment.

2. The apparatus of claim 1, wherein the everting portion of the replacement valve is configured to create a seal between the anchor and patient tissue.

3. The apparatus of claim 1, wherein the replacement valve is adapted to be held between the anchor and patient tissue upon eversion of the everting portion of the replacement valve about the anchor and expansion of the anchor.

4. The apparatus of claim 1 wherein at least a portion of the replacement valve is configured to be endovascularly delivered distal to the anchor.

5. The apparatus of claim 4 wherein substantially the entire replacement valve is configured to be endovascularly delivered distal to the anchor.

6. The apparatus of claim 1 further comprising a delivery system configured to endovascularly deliver the replacement valve and the anchor.

7. The apparatus of claim 6, wherein the delivery system is configured to evert the replacement valve.

8. The apparatus of claim 6, wherein the delivery system is configured to change the anchor'"'"'s shape.

9. The apparatus of claim 8, wherein the delivery system is configured to actively foreshorten the anchor.

10. The apparatus of claim 1, wherein the anchor and the replacement valve are telescoped relative to one another during endovascular delivery.

11. The apparatus of claim 1 further comprising a lock configured to maintain anchor expansion.

12. The apparatus of claim 1, wherein the anchor further comprises lip and skirt regions configured to expand and engage the patient'"'"'s heart valve.

13. The apparatus of claim 1, wherein the anchor further comprises a braid fabricated from a single strand of wire.

14. The apparatus of claim 1, wherein the replacement valve further comprises valve leaflets.

15. The apparatus of claim 14, wherein the everting segment comprises a material chosen from the group consisting of biologic materials, polymeric materials, fabric materials, permeable materials, impermeable materials, materials that promote tissue ingrowth, materials that retard tissue ingrowth, foam materials, sealing materials, and combinations thereof.

16. The apparatus of claim 1, further comprising a replacement valve support adapted to support the replacement valve in a deployed configuration.

17. The apparatus of claim 16, further comprising a supporting connection between the replacement valve and the replacement valve support.

18. The apparatus of claim 17, wherein the supporting connection is adapted to support replacement valve commissures.

19. The apparatus of claim 16, wherein the replacement valve support and at least a portion of the anchor are adapted to move with respect to each other during endovascular deployment of the anchor and replacement valve.

20. The apparatus of claim 16, wherein the replacement valve support comprises a lock adapted to lock configured to maintain anchor expansion.

21. A method for endovascularly replacing a patient'"'"'s heart valve, the method comprising:

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

everting at least an everting portion of the replacement valve about the anchor; and

expanding the anchor to a deployed configuration.

22. The method of claim 21, further comprising using the everting portion of the replacement valve as a seal between the anchor and patient tissue.

23. The method of claim 21, wherein expanding the anchor to the deployed configuration further comprises holding the replacement valve between the anchor and patient tissue.

24. The method of claim 21, wherein expanding the anchor to the deployed configuration further comprises actively foreshortening the anchor.

25. The method of claim 21, wherein expanding the anchor to the deployed configuration further comprises expanding lip and skirt regions of the anchor into engagement with the patient'"'"'s heart valve.

26. The method of claim 21, further comprising approximating the anchor and the replacement valve.

27. The method of claim 21, wherein the delivering step further comprises endovascularly delivering a replacement valve support, the method further comprising moving the replacement valve support and at least a portion of the anchor with respect to each other during deployment of the replacement valve.

28. The method of claim 27, further comprising using the replacement valve support to lock the anchor in the deployed configuration.

29. The method of claim 21, further comprising locking the anchor in the deployed configuration.

30. The method of claim 21, further comprising repositioning the replacement valve and the anchor.

31. The method of claim 21, further comprising retrieving the replacement valve and the anchor.

32. The method of claim 21, wherein the delivering step comprises endovascularly delivering at least a portion of the replacement valve distal to the anchor.

33. The method of claim 32, wherein the delivering step comprises endovascularly delivering the entire replacement valve distal to the anchor.

34. Apparatus for endovascularly replacing a patient'"'"'s heart valve, the apparatus comprising:

an anchor having a lip region and a skirt region; and

a replacement valve,

wherein at least an everting portion of the replacement valve is configured to evert about the skirt region of the anchor during endovascular deployment, and

wherein the lip and skirt regions of the anchor are configured for percutaneous expansion to engage the patient'"'"'s heart valve.

35. The apparatus of claim 34, wherein percutaneous expansion of the skirt region is configured to hold the everting portion of the replacement valve between the skirt region and the patient'"'"'s heart valve.

36. The apparatus of claim 34, wherein the everting portion of the replacement valve is configured to create a seal between the anchor and patient tissue.

37. The apparatus of claim 34, wherein the anchor further comprises a braid fabricated from a single strand of wire.

38. A method for endovascularly replacing a patient'"'"'s heart valve, the method comprising:

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

endovascularly wrapping at least a wrapping portion of the replacement valve about the anchor; and

expanding the anchor to a deployed configuration.

39. The method of claim 38, further comprising using the wrapping portion of the replacement valve as a seal between the anchor and patient tissue.

40. The method of claim 38, wherein expanding the anchor to the deployed configuration further comprises holding the wrapping portion of the replacement valve between the anchor and patient tissue.

41. The method of claim 38, wherein wrapping at least a portion of the replacement valve about the anchor further comprises everting at least a portion of the replacement valve about the anchor.

42. The method of claim 38 wherein endovascularly delivering the replacement valve and anchor further comprises delivering and deploying the valve and anchor without connecting the valve to expandable portions of the anchor.

43. The method of claim 38, wherein the delivering step comprises endovascularly delivering at least a portion of the replacement valve distal to the anchor.

44. The method of claim 43, wherein the delivering step comprises endovascularly delivering the entire replacement valve distal to the anchor.

45. The method of claim 39, wherein the delivering step further comprises endovascularly delivering a replacement valve support, the method further comprising moving the replacement valve support and at least a portion of the anchor with respect to each other during deployment of the replacement valve.

46. The method of claim 45, further comprising using the replacement valve support to lock the anchor in the deployed configuration.

47. The method of claim 39, wherein expanding the anchor to the deployed configuration further comprises actively foreshortening the anchor.

48. The method of claim 39, wherein expanding the anchor to the deployed configuration further comprises approximating the anchor and the replacement valve.

49. The method of claim 39 further comprising locking the anchor in the deployed configuration.

50. The method of claim 39 further comprising repositioning the replacement valve and the anchor.

51. The method of claim 39 further comprising retrieving the replacement valve and the anchor.

52. Apparatus for endovascularly replacing a patient'"'"'s heart valve, the apparatus comprising:

a replacement valve; and

an expandable anchor,

wherein the replacement valve and the anchor are configured for endovascular delivery to a vicinity of the patient'"'"'s heart valve with no portion of the replacement valve being wrapped about the anchor, and

wherein at least a wrapping portion of the replacement valve is configured to be wrapped about an end of the anchor in a deployed configuration.

53. The apparatus of claim 52, wherein the wrapping portion of the replacement valve is configured to create a seal between the anchor and patient tissue.

54. The apparatus of claim 52 wherein at least a portion of the replacement valve is configured to be endovascularly delivered distal to the anchor.

55. The apparatus of claim 54 wherein substantially the entire replacement valve is configured to be endovascularly delivered distal to the anchor.

56. The apparatus of claim 52, wherein the replacement valve is not connected to the expandable anchor.

57. The apparatus of claim 52, wherein at least a portion of the replacement valve is configured to evert about the anchor during endovascular deployment.

58. The apparatus of claim 52, wherein the wrapped portion of the replacement valve is configured to be held between the anchor and the patient tissue upon endovascular deployment.

59. The apparatus of claim 52, wherein the expandable anchor is configured for active foreshortening during endovascular deployment.

60. The apparatus of claim 52 further comprising a lock configured to maintain expansion of the anchor.

61. The apparatus of claim 52, wherein the lock is reversible.

62. The apparatus of claim 52, further comprising a replacement valve support adapted to support the replacement valve in a deployed configuration.

63. The apparatus of claim 62, further comprising a supporting connection between the replacement valve and the replacement valve support.

64. The apparatus of claim 63, wherein the supporting connection is adapted to support replacement valve commissures.

65. The apparatus of claim 62, wherein the replacement valve support is adapted to move with respect to the anchor during endovascular deployment of the anchor and replacement valve.

66. The apparatus of claim 62, wherein the replacement valve support comprises a lock adapted to lock configured to maintain anchor expansion.

67. The apparatus of claim 62, wherein the anchor comprises a braid fabricated from a single strand of wire.