Methods and apparatus for endovascular heart valve replacement comprising tissue grasping elements

• US 20060058872A1
• Filed: 09/20/2005
• Published: 03/16/2006
• 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: Hildebrand, Daniel, Salahieh, Amr, Saul, Tom
• Granted Patent: US 8,052,749 B2
• Time in Patent Office: Days
• US Class Current: 623/2.180
• 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 2/2427 Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: A61F 2/2433 using balloon catheter
• CPC Class Codes: A61F 2/2439 Expansion controlled by filaments
• CPC Class Codes: A61F 2/848 having means for fixation to the vessel wall, e.g. barbs
• CPC Class Codes: A61F 2/88 the wire-like elements formed as helical or spiral coils forming a net-like or mesh-like structure A61F2/90
• CPC Class Codes: A61F 2/90 characterised by a net-like or mesh-like structure
• 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 2220/0033 made by longitudinally pushing a protrusion into a complementary-shaped recess, e.g. held by friction fit
• CPC Class Codes: A61F 2220/0058 soldered or brazed or welded
• 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 2250/0069 Sealing means

Abstract

The present invention provides an apparatus for endovascularly replacing a patient'"'"'s heart valve. In some embodiments, the apparatus includes 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 having a braid having atraumatic grasping elements adapted to grasp tissue in a vicinity of the patient'"'"'s heart valve.

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 a braid having atraumatic grasping elements adapted to grasp tissue in a vicinity of the patient'"'"'s heart valve.

2. The apparatus of claim 1 further comprising a lock adapted to lock the anchor in a deployed configuration.

3. The apparatus of claim 1 wherein the grasping elements are stiffer than the braid.

4. The apparatus of claim 1, wherein the grasping elements are fabricated from a different material than a material from which the braid of the anchor is fabricated.

5. The apparatus of claim 1, wherein the grasping elements comprise a different cross-sectional profile than a cross-sectional profile of wires forming the braid of the anchor.

6. The apparatus of claim 1 wherein the grasping elements are integral with the braid.

7. The apparatus of claim 1 wherein the grasping elements are attached to the braid.

8. The apparatus of claim 1, wherein the tissue in the vicinity of the patient'"'"'s heart valve comprises valve leaflets of the patient'"'"'s heart valve.

9. The apparatus of claim 8 wherein the grasping elements extend from a proximal region of the anchor.

10. The apparatus of claim 9 wherein the proximal region of the anchor is adapted to resist distal movement of the anchor after grasping of the valve leaflets by the grasping elements.

11. The apparatus of claim 10 wherein the grasping elements are configured to pull the valve leaflets toward the braid during diastole.

12. The apparatus of claim 8, wherein the apparatus comprises at least three grasping elements adapted to grasp the valve leaflets.

13. The apparatus of claim 8, wherein the tissue further comprises valve commissures.

14. The apparatus of claim 1, wherein the tissue in the vicinity of the patient'"'"'s heart valve comprises a valve annulus of the heart valve.

15. The apparatus of claim 14 wherein the grasping elements extend from a distal region of the anchor.

16. The apparatus of claim 15 wherein the distal region of the anchor is adapted to resist proximal movement of the anchor after grasping of the valve annulus by the grasping elements.

17. The apparatus of claim 1, wherein the grasping elements extend from multiple locations along a length of the anchor.

18. The apparatus of claim 1, wherein the grasping elements are configured to grasp both an annulus and leaflets of the heart valve.

19. The apparatus of claim 1, 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.

20. The apparatus of claim 19, wherein the grasping elements are positioned substantially parallel with the braid of the anchor in the delivery configuration.

21. The apparatus of claim 20, wherein the grasping elements form a first angle with the braid of the anchor in the at-rest configuration.

22. The apparatus of claim 21, wherein the grasping elements form a second angle with the braid of the anchor in the deployed configuration.

23. The apparatus of claim 22, wherein the first angle is larger than the second angle.

24. The apparatus of claim 22, wherein the second angle is larger than the first angle.

25. The apparatus of claim 22, wherein the self-expanding anchor is configured for active expansion from the at-rest configuration to the deployed configuration.

26. The apparatus of claim 19, wherein the grasping elements are configured to grasp the tissue during transition from the at-rest configuration to the deployed configuration.

27. The apparatus of claim 19, wherein the anchor and replacement valve are adapted for percutaneous delivery with the anchor positioned in the delivery configuration within a delivery sheath, and wherein the anchor is configured to self-expand to the at-rest configuration upon deployment from the delivery sheath.

28. The apparatus of claim 27, wherein the apparatus is configured for resheathing upon deployment from the delivery sheath.

29. The apparatus of claim 1 wherein the grasping elements are adapted to move radially relative to one another during expansion of the anchor.

30. The apparatus of claim 1, wherein the grasping elements are adapted to move laterally relative to one another during expansion of the anchor.

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

32. The apparatus of claim 1 further comprising a seal around the grasping elements.

33. The apparatus of claim 32, wherein at least a portion of the seal is adapted to be captured between leaflets of the patient'"'"'s heart valve and a wall of the patient'"'"'s heart when the anchor and replacement valve are fully deployed.

34. The apparatus of claim 32, wherein at least a portion of the seal is adapted to be captured against an annulus of the patient'"'"'s heart valve.

35. The apparatus of claim 32, wherein the grasping elements comprise proximal grasping elements configured to grasp leaflets of the heart valve and distal grasping elements configured to grasp an annulus of the heart valve, and wherein the seal extends between the proximal and distal grasping elements to reduce blood flow around the replacement valve when the anchor and replacement valve are fully deployed.

36. The apparatus of claim 1, wherein the grasping elements are adapted to rotate about the anchor during expansion of the anchor.

37. 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 grasping elements adapted to grasp tissue in a vicinity of the patient'"'"'s heart valve,

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,

wherein the grasping elements are positioned substantially parallel with the anchor in the delivery configuration, at a first angle with the anchor in the at-rest configuration and at a second angle with the anchor in the deployed configuration.

38. The apparatus of claim 37 further comprising a lock adapted to lock the anchor in the deployed configuration.

39. The apparatus of claim 37, wherein the first angle is larger than the second angle.

40. The apparatus of claim 37, wherein the second angle is larger than the first angle.

41. The apparatus of claim 37, wherein the grasping elements are configured to grasp the tissue during transition from the at-rest configuration to the deployed configuration.

42. The apparatus of claim 37, wherein the self-expanding anchor is configured for active expansion from the at-rest configuration to the deployed configuration.

43. The apparatus of claim 37, wherein the anchor and replacement valve are adapted for percutaneous delivery with the anchor positioned in the delivery configuration within a delivery sheath, and wherein the anchor is configured to self-expand to the at-rest configuration upon deployment from the delivery sheath.

44. The apparatus of claim 43, wherein the apparatus is configured for resheathing upon deployment from the delivery sheath.

45. The apparatus of claim 37, wherein the grasping elements are adapted to rotate about the anchor during expansion of the anchor.