Repositionable heart valve and method

• US 20050137688A1
• Filed: 12/23/2003
• 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: Krolik, Jeff, Valencia, Hans F., Morejohn, Dwight P., Haug, Ulrich R., Brandt, Brian D., Geshlider, Robert A., Salahieh, Amr, Dueri, Jean-Pierre
• Granted Patent: US 8,840,663 B2
• Time in Patent Office: Days
• US Class Current: 623/2.110
• 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 2/2415 Manufacturing methods
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2210/0014 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2220/0083 using hook and loop-type fasteners
• 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 2250/0039 differing in diameter

Abstract

A method for percutaneously replacing a heart valve of a patient. In some embodiments the method includes the steps of percutaneously delivering a replacement valve and an expandable anchor to a vicinity of the heart valve in an unexpanded configuration; expanding the anchor to a deployed configuration in which the anchor contacts tissue at a first anchor site; repositioning the anchor to a second anchor site; and deploying the anchor at the second anchor site.

Claims

1. 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 an unexpanded configuration;

expanding the anchor to a deployed configuration in which the anchor contacts tissue at a first anchor site;

repositioning the anchor to a second anchor site; and

deploying the anchor at the second anchor site.

2. The method of claim 1 wherein the repositioning step comprises contracting the anchor and re-expanding the anchor at the second anchor site.

3. The method of claim 2 wherein the contracting step comprises applying an external non-hydraulic or non-pneumatic actuation force on the anchor.

4. The method of claim 1 wherein the deploying step comprises releasing the anchor from a deployment tool.

5. The method of claim 1 wherein the delivering step comprises delivering the replacement heart valve coupled to the anchor.

6. The method of claim 1 wherein the delivering step comprises delivering the replacement valve separate from the anchor, the method further comprising attaching the replacement valve to the anchor.

7. The method of claim 1 wherein the heart valve comprises an aortic valve and wherein the delivering step comprises endovascularly delivering the expandable anchor and replacement valve to the vicinity of the aortic valve along a retrograde approach.

8. The method of claim 1 wherein the expanding step comprises applying an external non-hydraulic or non-pneumatic actuation force on the anchor.

9. The method of claim 1 wherein the deploying step comprises expanding a balloon within the anchor.

10. The method of claim 1 wherein the deploying step comprises locking the anchor in an expanded configuration.

11. The method of claim 1 further comprising registering the anchor with the first or second anchor site.

12. The method of claim 11 wherein the registering step comprises contacting tissue of the heart valve to resist movement of the anchor in at least a proximal or a distal direction prior to deploying the anchor.

13. The method of claim 1 wherein the anchor comprises a proximal region and a distal region and wherein the expanding step comprises expanding the proximal and distal regions separately.

37. The method of claim 1 wherein the deploying step comprises unlocking the anchor and adjusting its position in an expanded configuration before locking the anchor and releasing the anchor from a deployment tool.

38. The method of claim 1 wherein the deployment step comprises unlocking the anchor and adjusting its position in an expanded configuration.

39. The method of claim 1 wherein the deployment step comprises unlocking the anchor.

14. 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 an unexpanded configuration;

expanding the anchor to an expanded configuration in which the anchor contacts tissue at an anchor site;

visually observing the anchor location; and

releasing the anchor from a deployment tool.

15. The method of claim 14 wherein the expanding step comprises expanding the anchor to contact the tissue with a force of about 2 to 4 pounds.

16. The method of claim 14 wherein the anchor site comprises a first anchor site, the method further comprising repositioning the anchor to a second anchor site after the observing step and before the releasing step.

17. The method of claim 14 wherein the expanding step comprises applying an external non-hydraulic or non-pneumatic actuation force on the anchor.

18. The method of claim 14 further comprising expanding a balloon within the anchor after the observing step.

19. The method of claim 14 further comprising registering the anchor with the anchor site.

20. The method of claim 14 wherein the delivering step comprises delivering the replacement heart valve coupled to the anchor.

21. The method of claim 14 wherein the delivering step comprises delivering the replacement valve separate from the anchor, the method further comprising attaching the replacement valve to the anchor.

22. 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 an unexpanded configuration;

expanding the anchor to a deployed configuration in which the anchor contacts tissue at an anchor site at the vicinity of the heart valve;

repositioning the anchor in the anchor site; and

deploying the anchor at the anchor site.

23. The method of claim 22 wherein the reposition step comprises contacting the anchor and re-expanding the anchor at the anchor site.

24. The method of claim 23 wherein the contacting step comprises applying an external non-hydraulic or non-pneumatic actuation force on the anchor.

25. The method of claim 22 wherein the deploying step comprises releasing the anchor from a deployment tool.

26. The method of claim 22 wherein the delivering step comprises delivering the replacement heart valve coupled to the anchor.

27. The method of claim 22 wherein the delivering step comprises delivering the replacement valve separate from the anchor, wherein the method further comprised attaching the replacement valve to the anchor.

28. The method of claim 22 wherein the heart valve comprises an aortic valve and wherein the delivering step comprises endovascularly delivering the expandable anchor and replacement valve to the vicinity of the aortic valve along a retrograde approach.

29. The method of claim 22 wherein the expanding step comprises applying an external non-hydraulic or non-pneumatic actuation force on the anchor.

30. The method of claim 22 wherein the deploying step comprises expanding a balloon within the anchor.

31. The method of claim 22 wherein the deploying step comprises locking the anchor in an expanded configuration.

32. The method of claim 22 further comprising registering the anchor with the anchor site.

33. The method of claim 32 wherein the registering step comprises contacting tissue of the heart valve to resist movement of the anchor in at least a proximal or a distal direction prior to deploying the anchor.

34. The method of claim 22 wherein the anchor comprises a proximal region and a distal region and wherein the expanding step comprises expanding the proximal and distal regions separately.

35. The method of claim 22 further comprising visually observing the anchor location.

36. The method of claim 35 wherein the step of observing occurs prior to locking the anchor.

40. The method of claim 22 wherein the deploying step comprises unlocking the anchor and adjusting its position in an expanded configuration before locking the anchor and releasing the anchor from a deployment tool.

41. The method of claim 22 wherein the deployment step comprises unlocking the anchor and adjusting its position in an expanded configuration.

42. The method of claim 22 wherein the deployment step comprises unlocking the anchor.