Mitral Spacer

• US 20090043382A1
• Filed: 11/15/2007
• Published: 02/12/2009
• Est. Priority Date: 10/26/2005
• Status: Active Grant

• Current Assignee: Cardiosolutions, Inc.
• Original Assignee: Cardiosolutions, Inc.
• Inventors: Wilson, Jonathan E., Maurer, Christopher W.
• Granted Patent: US 7,785,366 B2
• Time in Patent Office: Days
• US Class Current: 623/2.360
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/0441 the shaft being a rigid coil or spiral
• CPC Class Codes: A61B 2017/048 for reducing heart wall tension, e.g. sutures with a pad on each extremity
• 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 and an anchor configured to be coupled to an end of the shaft. A spacer may be coupled to a portion of the shaft and comprise a plurality of individual segments including a first and at least a second individual segment. The first segment may be coupled to the shaft. The second segment may be coupled to at least a portion of an exterior surface of the first segment and may have at least one cross-section dimension which is greater than an internal cross-sectional dimension of a delivery lumen. Additional segments may be coupled to an inner, adjacent segment. The segments may include a collapsible body portion to facilitate percutaneously delivery through a lumen. The segments may define an outer surface of the 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 the heart valve in a closed position.

Claims

1. A heart valve implant comprising:

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

a spacer comprising a plurality of individual segments including at least a first segment configured to be coupled to said shaft and at least a second segment configured to be coupled to at least a portion of an outer surface of said first segment, wherein said plurality of individual segments define an outer surface of 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

at least one anchor configured to be coupled to a first end region of said shaft.

2. A heart valve implant according to claim 1, wherein said at least a second segment is configured to be substantially concentric with said at least a first segment.

3. A heart valve implant according to claim 1, wherein said at least a second segment is configured to be substantially coextensive with said at least a first segment.

4. A heart valve implant according to claim 1, wherein said at least a first and a second segments are configured have a generally cylindrical shape.

5. A heart valve implant according to claim 1, wherein said at least a second segment defines a cavity configured to receive at least a portion of an inner, adjacent segment.

6. A heart valve implant according to claim 5, wherein said cavity is configured to provide an interference fit with said at least a portion of said inner, adjacent segment.

7. A heart valve implant according to claim 5, wherein said cavity is configured to substantially radially circumscribe said at least a portion of said inner, adjacent segment.

8. A heart valve implant according to claim 5, wherein said cavity is configured to be radially disposed about less than 360 degrees of an outer surface of said inner, adjacent segment.

9. A heart valve implant according to claim 1, wherein said at least a second segment comprises an expandable portion.

10. A heart valve implant according to claim 9, wherein said expandable portion comprises an inflatable bladder.

11. A heart valve implant according to claim 9, wherein said expandable portion comprises a shape memory material configured to recoverably deform.

12. A heart valve implant according to claim 1, wherein said at least a second segment is configured to be removeably coupled with an inner, adjacent segment.

13. A heart valve implant according to claim 1, wherein at least one of said plurality of individual segments includes a fastener for coupling with an adjacent segment.

14. A heart valve implant according to claim 13, wherein said fastener includes at least one detent configured to engage with said adjacent segment.

15. A heart valve implant according to claim 14, wherein said at least one detent comprises a resilient detent configured to resiliently deform and at least partially recover.

16. A heart valve implant according to claim 14, wherein said at least one detent comprises a spring-biased detent.

17. A heart valve implant according to claim 14, wherein said at least one detent comprises a substantially solid detent.

18. A heart valve implant according to claim 1, wherein said at least a second segment is configured to be coupled with an inner, adjacent segment using an adhesive.

19. A heart valve implant according to claim 1, wherein said spacer includes at least one outer cross-section dimension configured to be larger than an internal cross-section of delivery lumen.

23. A method according to claim 11, wherein percutaneously delivering said shaft and said serially aligned plurality of individual segments comprises reducing a volume of at least said second segment.

24. A method according to claim 23, further comprising expanding said at least a second, reduced volume segment after percutaneous delivery.

20. A method of introducing a heart valve implant with respect to a heart valve comprising:

providing a heart valve implant comprising a shaft, at least one anchor configured to be coupled to said shaft, and a spacer including a plurality of individual segments including a first and at least a second segment, wherein said plurality of individual segments define an outer surface of 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;

serially aligning said plurality of individual segments;

percutaneously delivering said shaft and said serially aligned plurality of segments proximate said heart;

coupling at least said first segment to said shaft;

coupling said at least a second segment to at least a portion of an outer surface of said first segment to define said spacer; and

securing said heart valve implant within said heart.

21. A method according to claim 20, wherein percutaneously delivering said shaft and said serially aligned plurality of individual segments comprises a catheterization intervention.

22. A method according to claim 20, wherein percutaneously delivering said shaft and said serially aligned plurality of individual segments comprises inserting said aligned plurality of individual segments and said shaft into a lumen of a catheter and delivering said aligned plurality of individual segments and said shaft to said left ventricle via said catheter.

25. A method according to claim 20, wherein coupling said at least a second segment to said at least a portion of said outer surface of said first segment comprises receiving at least a portion of said first segment at least partially within a cavity of said at least a second segment.

26. A method according to claim 25, further comprising forming an interference fit between said first segment and said cavity of said at least a second segment.

27. A method according to claim 25, further comprising coupling said at least one a second segment to said first segment using at least one detent disposed on at least one of said first and said at least a second segment.

28. A heart valve implant system comprising:

a catheter including a lumen; and

a heart valve implant comprising;

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

a spacer comprising a plurality of individual segments including at least a first segment configured to be coupled to said shaft and at least a second segment configured to be coupled to at least a portion of an outer surface of said first segment and having at least one cross-sectional dimension that is larger than an internal cross-section of said lumen, wherein said plurality of individual segments define an outer surface of 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

at least one anchor configured to be coupled to a first end region of said shaft.

29. A heart valve implant system according to claim 28, wherein said plurality of individual segments each include a body portion having a generally tubular shape.

30. A heart valve implant system according to claim 28, wherein at least said second segment comprises a cavity configured to at least partially receive at least a portion of said first segment.

31. A heart valve implant system according to claim 28, wherein said at least a second segment comprises a collapsible portion configured to received in said lumen.

32. A heart valve implant system according to claim 31, wherein said collapsed segment is configured to be expanded proximate said heart valve.