Leaflet engagement elements and methods for use thereof

• US 20050137698A1
• Filed: 10/21/2004
• Published: 06/23/2005
• Est. Priority Date: 12/23/2003
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Original Assignee: Sadra Medical, Inc. (Boston Scientific Corporation)
• Inventors: Morejohn, Dwight P., Brandt, Brian D., Salahieh, Amr, Saul, Tom, Gleshlider, Robert A.
• Granted Patent: US 7,748,389 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 2250/006 modular

Abstract

The present invention relates to apparatus for methods for endovascularly replacing a patient'"'"'s heart valve. The apparatus includes an expandable anchor with leaflet engagement elements on the proximal end of the anchor and a replacement valve. The leaflet engagement elements can be used to prevent distal migration and insure proper positioning of the apparatus.

Claims

1. Apparatus for endovascularly replacing a patient'"'"'s heart valve, the apparatus comprising an expandable anchor supporting a replacement valve, the anchor and replacement valve being adapted for percutaneous delivery and deployment to replace the patient'"'"'s heart valve, the anchor comprising leaflet engagement elements on a proximal end of the anchor adapted to engage leaflets of the patient'"'"'s heart valve.

2. The apparatus of claim 1 wherein the anchor is further adapted to be substantially distal to coronary ostia of the patient when the anchor is fully deployed.

3. The apparatus of claim 1 wherein the anchor is further adapted to be actively foreshortened during deployment.

4. The apparatus of claim 3 further comprising proximal anchor actuation elements adapted to apply an actuation force on a proximal portion of the anchor.

5. The apparatus of claim 3 further comprising distal anchor actuation elements adapted to apply an actuation force on a distal portion of the anchor.

6. The apparatus of claim 3 further comprising a lock adapted to lock the anchor in a deployed shape.

7. The apparatus of claim 1 wherein the proximal end of the anchor is adapted to resist distal movement during expansion of the anchor after engagement of the valve leaflets by the engagement elements.

8. The apparatus of claim 1 wherein the leaflet engagement elements are adapted to move radially apart as the anchor expands.

9. The apparatus of claim 1 wherein the leaflet engagement elements are integral with the anchor.

10. The apparatus of claim 9 wherein the anchor comprises a braid, the leaflet engagement elements being part of the braid.

11. The apparatus of claim 1 wherein the anchor and the replacement valve are further adapted to permit blood flow from a chamber of the heart through the replacement valve and to prevent blood flow to the chamber of the heart through the replacement valve during deployment of the anchor and replacement valve.

12. The apparatus of claim 1 further comprising a delivery catheter adapted to deliver the anchor and replacement valve to a vicinity of the heart, wherein the anchor and the replacement valve are further adapted to permit blood flow through the replacement valve and to prevent blood backflow through the replacement valve after the replacement valve exits the catheter and before final deployment of the anchor.

13. The apparatus of claim 12 wherein the anchor and the replacement valve are further adapted to permit blood flow through the replacement valve and to prevent blood backflow through the replacement valve after the replacement valve exits the catheter but before the anchor completely exits the catheter.

14. The apparatus of claim 12 wherein the anchor comprises a self-expanding anchor.

15. The apparatus of claim 12 wherein the anchor comprises a self-expanding anchor having a delivery configuration, an at-rest configuration and a deployed configuration, the at-rest configuration having a diameter larger than a diameter of the delivery configuration.

16. The apparatus of claim 12 wherein the anchor comprises a self-expanding anchor having a delivery configuration, an at-rest configuration and a deployed configuration, the at-rest configuration having a diameter larger than a diameter of the delivery configuration and smaller than a diameter of the deployed configuration.

17. The apparatus of claim 12 wherein the anchor and the replacement valve are further adapted to permit blood flow through the replacement valve and around the catheter after the replacement valve exits the catheter and before final deployment of the anchor.

18. The apparatus of claim 12 wherein the anchor and the replacement valve are further adapted to permit blood flow through the replacement valve and into coronary ostia of the heart after the replacement valve exits the catheter and before final deployment of the anchor.

19. The apparatus of claim 1 further comprising a seal adapted to prevent blood flow around the replacement valve when the anchor and replacement valve are fully deployed.

20. The apparatus of claim 19 wherein the seal comprises a pleated seal.

21. The apparatus of claim 19 wherein at least a portion of the seal is adapted to be captured between the leaflets of the patient'"'"'s heart valve and a wall of the patient'"'"'s heart when the anchor and replacement valve are fully deployed.

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

endovascularly delivering an anchor and a replacement valve supported within the anchor to a vicinity of the heart valve in a collapsed delivery configuration, the anchor comprising leaflet engagement elements on a proximal end of the anchor adapted to engage native valve leaflets;

expanding the anchor; and

engaging the leaflet engagement elements with native valve leaflets.

23. The method of claim 22 further comprising expanding the anchor into engagement with the patient'"'"'s heart such that the anchor is substantially distal to coronary ostia of the heart.

24. The method of claim 23 wherein the expanding step comprises actively foreshortening the anchor.

25. The method of claim 24 wherein the actively foreshortening step comprises actuating distal anchor actuation elements.

26. The method of claim 24 wherein the actively foreshortening step comprises actuating proximal anchor actuation elements.

27. The method of claim 24 further comprising locking the anchor in a deployed configuration.

28. The method of claim 22 further comprising resisting distal movement of the proximal end of the anchor after the engaging step.

29. The method of claim 22 further comprising moving the leaflet engagement elements further apart radially during the anchor expanding step.

30. The method of claim 22 further comprising permitting blood flow through the replacement valve and preventing blood backflow through the replacement valve during deployment of the anchor and replacement valve.

31. The method of claim 22 further comprising:

delivering the anchor and replacement valve to a vicinity of the heart in a delivery catheter;

removing the anchor and the replacement valve from the catheter; and

permitting blood flow through the replacement valve and preventing blood backflow through the replacement valve after the replacement valve exits the catheter and before final deployment of the anchor.

32. The method of claim 31 wherein the permitting and preventing steps are performed before the anchor completely exits the catheter.

33. The method of claim 31 wherein the permitting step comprises allowing the anchor to self-expand.

34. The method of claim 31 wherein the permitting step comprises permitting blood flow through the replacement valve and around the catheter after the replacement valve exits the catheter and before final deployment of the anchor.

35. The method of claim 31 wherein the permitting step comprises permitting blood flow through the replacement valve and into coronary ostia of the heart after the replacement valve exits the catheter and before final deployment of the anchor.

36. The method of claim 22 further comprising sealing between the replacement valve and the heart.

37. The method of claim 36 wherein the sealing step comprises pleating a seal.

38. The method of claim 36 wherein the sealing step comprises capturing at least a portion of a seal between the leaflets and a wall of the heart.

39. Apparatus for endovascularly replacing a patient'"'"'s heart valve, the apparatus comprising an expandable anchor supporting a replacement valve, the anchor and replacement valve being adapted for percutaneous delivery and deployment to replace the patient'"'"'s heart valve, the anchor comprising a braid, the braid comprising leaflet engagement elements adapted to engage leaflets of the patient'"'"'s heart valve.

40. The apparatus of claim 39 wherein the leaflet engagement elements extend from a proximal end of the anchor.

41. The apparatus of claim 39 wherein the anchor is further adapted to be substantially distal to coronary ostia of the patient when the anchor is fully deployed.

42. The apparatus of claim 39 wherein the anchor is further adapted to be actively foreshortened during deployment.

43. The apparatus of claim 42 further comprising proximal anchor actuation elements adapted to apply an actuation force on a proximal portion of the anchor.

44. The apparatus of claim 42 further comprising distal anchor actuation elements adapted to apply an actuation force on a distal portion of the anchor.

45. The apparatus of claim 42 further comprising a lock adapted to lock the anchor in a deployed shape.

46. The apparatus of claim 40 wherein the proximal end of the anchor is adapted to resist distal movement during expansion of the anchor after engagement of the valve leaflets by the engagement elements.

47. The apparatus of claim 40 wherein the leaflet engagement elements are adapted to move radially apart as the anchor expands.

48. The apparatus of claim 40 wherein the anchor and the replacement valve are further adapted to permit blood flow from a chamber of the heart through the replacement valve and to prevent blood flow through the replacement valve during deployment of the anchor and replacement valve.

49. The apparatus of claim 40 further comprising a delivery catheter adapted to deliver the anchor and replacement valve to a vicinity of the heart, wherein the anchor and the replacement valve are further adapted to permit blood flow through the replacement valve and to prevent blood backflow through the replacement valve after the replacement valve exits the catheter and before final deployment of the anchor.

50. The apparatus of claim 49 wherein the anchor and the replacement valve are further adapted to permit blood flow through the replacement valve and to prevent blood backflow through the replacement valve after the replacement valve exits the catheter and before the anchor completely exits the catheter.

51. The apparatus of claim 49 wherein the anchor comprises a self-expanding anchor.

52. The apparatus of claim 49 wherein the anchor comprises a self-expanding anchor having a delivery configuration, an at-rest configuration and a deployed configuration, the at-rest configuration having a diameter larger than a diameter of the delivery configuration.

53. The apparatus of claim 49 wherein the anchor comprises a self-expanding anchor having a delivery configuration, an at-rest configuration and a deployed configuration, the at-rest configuration having a diameter larger than a diameter of the delivery configuration and smaller than a diameter of the deployed configuration.

54. The apparatus of claim 49 wherein the anchor and the replacement valve are further adapted to permit blood flow through the replacement valve and around the catheter after the replacement valve exits the catheter and before final deployment of the anchor.

55. The apparatus of claim 49 wherein the anchor and the replacement valve are further adapted to permit blood flow through the replacement valve and into coronary ostia of the heart after the replacement valve exits the catheter and before final deployment of the anchor.

56. The apparatus of claim 40 further comprising a seal adapted to prevent blood flow around the replacement valve when the anchor and replacement valve are fully deployed.

57. The apparatus of claim 56 wherein the seal comprises a pleated seal.

58. The apparatus of claim 56 wherein at least a portion of the seal is adapted to be captured between the leaflets of the patient'"'"'s heart valve and a wall of the patient'"'"'s heart when the anchor and replacement valve are fully deployed.