Everting heart valve

• US 7,780,725 B2
• Filed: 06/16/2004
• Issued: 08/24/2010
• Est. Priority Date: 06/16/2004
• 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., Haug, Ulrich R., Geshlider, Robert A., Michlitsch, Kenneth J., Salahieh, Amr, Saul, Tom
• Primary Examiner(s): Isabella; David
• Assistant Examiner(s): SCHILLINGER, ANN M
• Application Number:
  US10/870,340
• Publication Number:
  US 20050283231A1
• Time in Patent Office: 2,260 Days
• Field of Search: 623 11- 21, 623 211- 242, 128/898
• US Class Current: 623/2.17
• 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. 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 maintaining said replacement valve secured to said anchor;

expanding the anchor to a fully deployed configuration in which the expandable anchor is anchored against tissue; and

everting at least an everting portion of the replacement valve about the expandable anchor prior to expanding the expandable anchor to the fully deployed configuration.

2. The method of claim 1, wherein expanding the anchor to the fully deployed configuration further comprises holding the replacement valve between the anchor and patient tissue.

3. The method of claim 1, wherein expanding the anchor to the fully deployed configuration further comprises actively foreshortening the anchor.

4. The method of claim 1, wherein expanding the anchor to the fully deployed configuration further comprises expanding lip and skirt regions of the anchor into engagement with the patient'"'"'s heart valve.

5. The method of claim 1, further comprising moving the anchor and the replacement valve axially closer together.

6. The method of claim 1, 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.

7. The method of claim 6, further comprising using the replacement valve support to lock the anchor in the deployed configuration.

8. The method of claim 1, further comprising locking the anchor in the deployed configuration.

9. The method of claim 1, further comprising repositioning the replacement valve and the anchor.

10. The method of claim 1, further comprising retrieving the replacement valve and the anchor.

11. The method of claim 1 wherein everting at least an everting portion of the replacement valve about the anchor comprises everting at least an everting portion of the replacement valve about the distal end of the anchor.

12. 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 during the deployment of the anchor;

expanding the anchor to a deployed configuration; and

using the everting portion of the replacement valve as a seal between the anchor and patient tissue.

13. 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 during the deployment of the anchor;

expanding the anchor to a deployed configuration; and

wherein the delivering step comprises endovascularly delivering at least a portion of the replacement valve distal to the anchor.

14. The method of claim 13, wherein the delivering step comprises endovascularly delivering the entire replacement valve distal to the anchor.

15. The method of claim 13 wherein the replacement valve comprises replacement valve leaflets, and wherein the delivering step comprises endovascularly delivering the replacement valve leaflets distal to the anchor.

16. The method of claim 15 wherein the everting step comprises everting the replacement valve leaflets from a position distal to the anchor to a position within the anchor.

17. 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 during the deployment of the anchor; and

expanding the anchor to a deployed configuration.

18. The method of claim 17, wherein expanding the anchor to the deployed configuration further comprises holding the wrapping portion of the replacement valve between the anchor and patient tissue.

19. The method of claim 17, 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.

20. The method of claim 17 wherein endovascularly wrapping at least a wrapping portion of the replacement valve about the anchor comprises wrapping at least a wrapping portion of the replacement valve about the distal end of the anchor.

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;

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

expanding the anchor to a deployed configuration; and

using the wrapping portion of the replacement valve as a seal between the anchor and patient tissue.

22. 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.

23. The method of claim 22, further comprising using the replacement valve support to lock the anchor in the deployed configuration.

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 moving the anchor and the replacement valve axially closer together.

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

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

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

29. 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 during the deployment of the anchor;

expanding the anchor to a deployed configuration; and

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.

30. 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 during the deployment of the anchor;

expanding the anchor to a deployed configuration; and

wherein the delivering step comprises endovascularly delivering at least a portion of the replacement valve distal to the anchor.

31. The method of claim 30, wherein the delivering step comprises endovascularly delivering the entire replacement valve distal to the anchor.