Safety for Mitral Valve Plug

• US 20070265700A1
• Filed: 05/14/2007
• Published: 11/15/2007
• Est. Priority Date: 10/26/2005
• Status: Active Grant

• Current Assignee: Cardiosolutions, Inc.
• Original Assignee: Cardiosolutions, Inc.
• Inventors: Wilson, Jonathan, Eliasen, Kenneth, Maurer, Christopher, Tallarida, Steven
• Granted Patent: US 8,778,017 B2
• Time in Patent Office: Days
• US Class Current: 623/2.100
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61F 2/246 Devices for obstructing a leak through a native valve in a closed condition

Abstract

A heart valve implant may include a shaft extending generally along a longitudinal axis of the heart valve implant. A spacer may be coupled to the shaft between a first and a second end region of the shaft. The spacer may be configured to interact with at least a portion of at least one cusp of a heart valve to at least partially restrict a flow of blood through the heart valve in a closed position and at least one anchor may be configured to be coupled to the first end region of the shaft. At least one safety stop may extend generally radially outwardly from the longitudinal axis of the heart valve implant beyond at least a portion of an outer perimeter of the spacer. The safety stop may include a cross-section which is greater than a cross-section of the heart valve in at least one dimension. The safety stop may also be configured to at least partially restrict a movement of the heart valve implant with respect to the heart valve in at least one direction.

Claims

1. A heart valve implant comprising:

a shaft extending generally along a longitudinal axis of said heart valve implant;

a spacer coupled to said shaft between a first and a second end region of said shaft, said spacer configured to interact with at least a portion of at least one cusp of a heart valve to at least partially restrict a flow of blood through said heart valve in a closed position;

at least one anchor configured to be coupled to said first end region of said shaft; and

at least one safety stop extending generally radially outwardly from said longitudinal axis of said heart valve implant beyond at least a portion of an outer perimeter of said spacer, said at least one safety stop configured to at least partially restrict a movement of said heart valve implant with respect to said heart valve in at least one direction.

2. A heart valve implant according to claim 1, wherein a cross-section of said at least one safety stop is greater than a cross-section of said heart valve in at least one dimension.

3. A heart valve implant according to claim 1, wherein said at least one safety stop extends generally radially outwardly from said shaft between said spacer and said second end region of said shaft.

4. A heart valve implant according to claim 3, wherein said at least one safety stop is disposed proximate a distal most portion of said second end region of said shaft.

5. A heart valve implant according to claim 1, wherein said at least one safety stop extends generally radially outwardly from said shaft between said spacer and said first end region of said shaft.

6. A heart valve implant according to claim 1, wherein said at least one safety stop includes a first safety stop extending generally radially outwardly from said shaft between said spacer and said second end region of said shaft and a second safety stop extending generally radially outwardly from said shaft between said spacer and said first end region of said shaft.

7. A heart valve implant according to claim 1, wherein said at least one safety stop extends generally radially outwardly from said at least one anchor.

8. A heart valve implant according to claim 1, wherein said at least one safety stop includes a first safety stop extending generally radially outwardly from said shaft between said spacer and said second end region of said shaft and a second safety stop extending generally radially outwardly from said at least one anchor.

9. A heart valve implant according to claim 1, wherein said at least one safety stop includes a generally circular outer perimeter.

10. A heart valve implant according to claim 9, wherein said at least one safety stop includes at least one spoke extending generally radially outwardly from said heart valve implant to said generally circular outer perimeter.

11. A heart valve implant according to claim 9, wherein said at least one safety stop includes a substantially solid, disc-like geometry.

12. A heart valve implant according to claim 11, wherein said at least one safety stop includes at least one openings configured to allow fluid to flow through said substantially solid, disc-like geometry.

13. A heart valve implant according to claim 1, wherein said at least one safety stop include at least one segment extending generally radially outwardly less than 360 degrees along a radius of said heart valve implant.

14. A heart valve implant according to claim 13, wherein said at least one safety stop includes a plurality of individual segments, wherein each segment extends generally radially outwardly less than 360 degrees along a radius of said heart valve implant.

15. A heart valve implant according to claim 13, wherein said at least one segment is no larger than the interior, radial dimensions of a delivery catheter lumen in at least one direction.

16. A heart valve implant according to claim 15 wherein said at least one segment is configured to be coupled to said heart valve implant upon delivery via said delivery catheter lumen.

17. A heart valve implant according to claim 1 wherein said at least one safety stop comprises an expandable portion.

18. A heart valve implant according to claim 17, wherein said expandable portion comprises an inflatable bladder.

19. A heart valve implant according to claim 17, wherein said expandable portion comprises a shape memory material configured to recoverably deform.

20. A heart valve implant according to claim 1, wherein at least a portion of said at least one safety stop includes a coating material configured to promote cell growth between said at least one safety stop and at least a portion of tissue adjacent said heart valve implant.

21. A method of restricting movement of a heart valve implant with respect to a heart valve comprising:

providing a heart valve implant comprising a shaft, a spacer coupled to said shaft between a first and a second end region of said shaft, at least one anchor configured to be coupled to said first end region of said shaft, and at least one safety stop extending generally radially outwardly from said heart valve implant beyond at least a portion of an outer perimeter of said spacer;

at least partially collapsing said heart valve implant;

percutaneously inserting said at least partially collapsed heart valve implant into a heart;

securing said at least partially collapsed heart valve implant within said heart;

expanding said collapsed heart valve implant, wherein said at least one safety stop is configured to at least partially restrict a movement of said heart valve implant with respect to said heart valve in at least one direction.

22. A method according to claim 21, wherein percutaneously inserting said collapsed heart valve implant comprises a catheterization intervention.

23. A method according to claim 22, wherein percutaneously inserting said at least partially collapsed heart valve implant comprises inserting said heart valve implant into a lumen of a catheter and delivering said heart valve implant to said left ventricle via said catheter.

24. A method according to claim 21, wherein said at least one safety stop comprises an expandable structure.

25. A method according to claim 24, wherein said at least one safety stop comprises a shape memory material, and expanding said heart valve implant comprises raising a temperature of said at least one safety stop to a temperature equal to, or greater than, an activation temperature of said shape memory material.

26. A method of restricting the movement of a heart valve implant comprising:

engaging an anchor into coronary tissue;

providing a shaft coupled to said anchor;

providing a spacer coupled to said shaft, said spacer configured to interact with at least a portion of at least one cusp of a heart valve to at least partially restrict a flow of blood through said heart valve in a closed position; and

providing at least one safety stop extending generally radially outwardly from said heart valve implant beyond at least a portion of an outer perimeter of said spacer, said at least one safety stop configured to at least partially restrict a movement of said heart valve implant with respect to said heart valve in at least one direction.

27. The method according to claim 26, wherein said at least one safety stop comprises an expandable portion.

28. A heart valve implant comprising:

a shaft;

a spacer coupled to said shaft between a first and a second end region of said shaft, said spacer configured to interact with at least a portion of at least one cusp of a heart valve to at least partially restrict a flow of blood through said heart valve in a closed position;

at least one anchor configured to be coupled to said first end region of said shaft; and

at least one safety stop extending generally radially outwardly from a longitudinal axis of said heart valve implant, wherein said at least one safety stop is configured to have a cross-section greater than a cross-section of said heart valve in at least one dimension.

29. A heart valve implant according to claim 28 wherein said at least one safety stop is configured to at least partially restrict a movement of said heart valve implant with respect to said heart valve in at least one direction.