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

• US 20060253191A1
• Filed: 09/20/2005
• Published: 11/09/2006
• 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: Hildebrand, Daniel, Salahieh, Amr, Saul, Tom
• Granted Patent: US 8,828,078 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 2/2418 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

A method for endovascularly replacing a patient'"'"'s heart valve including the following steps: 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 having grasping elements adapted to grasp tissue in a vicinity of the heart valve; expanding the anchor, thereby rotating the grasping elements; and grasping the tissue with the rotating grasping elements.

Claims

1. 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 grasping elements adapted to grasp tissue in a vicinity of the heart valve;

expanding the anchor, thereby rotating the grasping elements; and

grasping the tissue with the rotating grasping elements.

2. The method of claim 1 further comprising locking the anchor in a deployment configuration after the expanding and grasping steps.

3. The method of claim 1, wherein grasping the tissue with the rotating grasping elements further comprises grasping valve leaflets of the patient'"'"'s heart valve with the grasping elements.

4. The method of claim 3, wherein grasping valve leaflets of the heart valve with the grasping elements further comprises pulling the valve leaflets toward the anchor during diastole.

5. The method of claim 1, wherein grasping the tissue with the rotating grasping elements further comprises grasping an annulus of the patient'"'"'s heart valve with the grasping elements.

6. The method of claim 1, wherein grasping the tissue with the rotating grasping elements further comprises grasping both an annulus and valve leaflets of the patient'"'"'s heart valve with the grasping elements.

7. The method of claim 1 further comprising sealing the grasping elements against the tissue.

8. The method of claim 7, wherein sealing the grasping elements further comprises capturing at least a portion of a seal between leaflets of the heart valve and a wall of the heart.

9. The method of claim 7, wherein sealing the grasping elements further comprises capturing at least a portion of a seal against an annulus of the heart valve.

10. The method of claim 7, wherein sealing the grasping elements further comprises reducing blood flow around the replacement valve when the anchor and replacement valve are fully deployed.

11. The method of claim 1, wherein rotating the grasping elements further comprises moving the grasping elements radially relative to one another.

12. The method of claim 1, wherein rotating the grasping elements further comprises moving the grasping elements laterally relative to one another.

13. The method of claim 1 wherein grasping the tissue with the grasping elements further comprises resisting movement of the anchor in at least one direction via the grasping elements.

14. The method of claim 1, wherein expanding the anchor further comprises:

removing a constraint on the anchor such that the anchor self-expands from a delivery configuration to a larger diameter at-rest configuration; and

actively expanding the anchor to an even larger diameter deployed configuration.

15. The method of claim 14, wherein removing the constraint on the anchor further comprises rotating the grasping elements from a position substantially parallel with the anchor in the delivery configuration to a position at a first angle with the anchor in the at-rest configuration.

16. The method of claim 15, wherein actively expanding the anchor further comprises rotating the grasping elements from a position at the first angle with the anchor in the at-rest configuration to a position at a second angle with the anchor in the deployed configuration.

17. The method of claim 16, wherein the first angle is larger than the second angle.

18. The method of claim 16, wherein the second angle is larger than the first angle.

19. The method of claim 16, wherein grasping the tissue with the rotating grasping elements further comprises grasping the tissue during transition of the anchor from the at-rest configuration to the deployed configuration.

20. The method of claim 15, wherein endovascularly delivering the anchor and the replacement valve further comprises endovascularly delivering the anchor and the replacement valve within a delivery sheath, and wherein removing the constraint on the anchor further comprises deploying the anchor and the replacement valve from the delivery sheath.

21. The method of claim 20 further comprising resheathing the anchor and the replacement valve within the delivery sheath after self-expansion of the anchor to the at-rest configuration.

22. The method of claim 1, wherein grasping the tissue with the rotating grasping elements further comprises distributing forces applied to the tissue amongst the grasping elements, thereby reducing a risk of misalignment.