Devices, systems, and methods for reshaping a heart valve annulus

• US 20060106456A9
• Filed: 10/01/2003
• Published: 05/18/2006
• Est. Priority Date: 10/01/2002
• Status: Abandoned Application

• Current Assignee: MVRx, Inc.
• Original Assignee: Ample Medical, Inc. (MVRx, Inc.)
• Inventors: Machold, Timothy R., Rahdert, David A., Chang, Robert T., Macoviak, John A., Soss, Rick A.
• Application Number:
  US10/677,104
• Publication Number:
  US 20040127982A1
• Time in Patent Office: Days
• US Class Current: 623/2.360
• CPC Class Codes: A61B 17/22012 in direct contact with, or very close to, the obstruction or concrement for removing obstructions in blood vessels by laser A61B18/245
• CPC Class Codes: A61B 18/1492 having a flexible, catheter-like structure, e.g. for heart ablation A61B18/1477 takes precedence
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/00247 Making holes in the wall of the heart, e.g. laser Myocardial revascularization
• CPC Class Codes: A61B 2017/22097 Valve removal in veins
• CPC Class Codes: A61B 2017/320052 Guides for cutting instruments by marking A61B2090/395
• CPC Class Codes: A61B 2018/00392 Transmyocardial revascularisation
• CPC Class Codes: A61B 90/00 Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges protective face masks A41D13/11; surgeon's or patient's gowns or dresses A41D13/12; devices for carrying-off, for treatment of, or for carrying-over, body liquids A61M1/00
• CPC Class Codes: A61B 90/50 Supports for surgical instruments, e.g. articulated arms
• 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 2/2445 Annuloplasty rings in direct contact with the valve annulus
• CPC Class Codes: A61F 2/2454 Means for preventing inversion of the valve leaflets, e.g. chordae tendineae prostheses
• CPC Class Codes: A61F 2/2466 Delivery devices therefor
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: Y10S 623/904 Heart

Abstract

Devices, systems, and methods employ an implant that is sized and configured to attach to the annulus of a dysfunctional heart valve annulus. In use, the implant extends across the major axis of the annulus above and/or along the valve annulus. The implant reshapes the major axis dimension and/or other surrounding anatomic structures. The implant restores to the heart valve annulus and leaflets a more functional anatomic shape and tension. The more functional anatomic shape and tension are conducive to coaptation of the leaflets, which, in turn, reduces retrograde flow or regurgitation. The implant improves function to the valve, without surgically cinching, resecting, and/or fixing in position large portions of a dilated annulus, or without the surgical fixation of ring-like structures.

Claims

1. An implant to reshape a heart valve annulus comprising a body sized and configured to rest near or within a heart valve annulus, including a portion of the body contacting and outwardly displacing tissue to reshape the heart valve annulus.

7. An implant according to claim 1 or 2 or 3 or 4 or 5 or 6

wherein the body comprises an annular shape.

8. An implant according to claim 1 or 2 or 3 or 4 or 5 or 6

wherein the body comprises a closed annular shape.

9. An implant according to claim 1 or 2 or 3 or 4 or 5 or 6

wherein the body comprises an open annular shape.

10. An implant according to claim 1 or 2 or 3 or 4 or 5 or 6

wherein the body comprises at least one rail.

11. An implant according to claim 1 or 2 or 3 or 4 or 5 or 6

wherein the body comprises a wire-form structure.

12. An implant according to claim 1 or 2 or 3 or 4 or 5 or 6

wherein the body is collapsible for placement within a catheter.

13. An implant according to claim 1 or 2 or 3 or 4 or 5 or 6

wherein the body includes at least one cusp sized and configured to permit folding of the body without permanent deformation.

14. An implant according to claim 1 or 2 or 3 or 4 or 5 or 6

wherein the body carries a tissue in-growth material.

15. An implant according to claim 1 or 2 or 3 or 4 or 5 or 6

further including at least one structure appended to the body and being sized and configured to contact tissue at, above, or below the heart valve annulus to stabilize the body.

16. An implant according to claim 1 or 2 or 3 or 4 or 5 or 6

wherein the body is sized and configured to extend close to the annulus.

17. An implant according to claim 1 or 2 or 3 or 4 or 5 or 6

wherein the body is sized and configured to extend above the annulus.

18. An implant according to claim 1 or 2 or 3 or 4 or 5 or 6

wherein the body is sized and configured to contact tissue above the annulus.

19. An implant according to claim 1 or 2 or 3 or 4 or 5 or 6

wherein the body is sized and configured to include one portion that extends close to the annulus and another portion that extends above the annulus.

20. An implant according to claim 1 or 2 or 3 or 4 or 5 or 6

wherein the body is sized and configured to include one portion that extends close to the annulus and another portion that contacts tissue above the annulus.

21. An implant according to claim 1 or 2 or 3 or 4 or 5 or 6

wherein the body comprises an elastic material.

22. An implant according to claim 1 or 2 or 3 or 4 or 5 or 6

wherein the body comprises a plastically deformable material.

23. An implant according to claim 1 or 2 or 3 or 4 or 5 or 6

wherein the body comprises a superelastic material.

24. An implant according to claim 1 or 2 or 3 or 4 or 5 or 6

and further including a retaining element appended to the body and extending over at least a portion of a native heart valve leaflet, the restraining element being shaped to restrain retrograde movement of the heart valve leaflet.

25. An implant according to claim 1 or 2 or 3 or 4 or 5 or 6

and further including a neoleaflet element appended to the body and occupying the space of at least one native heart valve leaflet, the neoleaflet element being shaped to provide a one-way valve function.

26. An implant according to claim 1 or 2 or 3 or 4 or 5 or 6

and further including a second heart valve treatment element appended to the body to affect a heart valve function.

27. An implant according to claim 26

wherein the second heart valve treatment element includes means for supplementing, repairing, or replacing a native heart valve leaflet.

28. An implant according to claim 26

wherein the second heart valve treatment element includes means for retaining a native heart valve leaflet.

34. A method for reshaping a heart valve annulus comprising the steps of

introducing an implant as defined in claim 1 or 2 or 3 or 4 into a heart, and

displacing tissue to reshape the heart valve annulus by locating the body of the implant as defined in claim 1 or 2 or 3 or 4 near or within a heart valve annulus.

35. A method according to claim 34

wherein the introducing step comprises using an open heart surgical procedure.

36. A method according to claim 34

wherein the introducing step comprises using a surgical procedure in which the implant is carried within a catheter.

37. A method according to claim 34

wherein the introducing step comprises using an intravascular surgical procedure.

38. A method according to claim 34

wherein the displacing tissue step comprises tethering the body of the implant as defined in claim 1 or 2 or 3 or 4 to at least one wire while locating the body near or within a heart valve annulus.

2. An implant to reshape a heart valve annulus comprising a body sized and configured to rest in net compression near or within a heart valve annulus, including a portion of the body contacting tissue to displace tissue to reshape the heart valve annulus.

3. An implant to reshape a heart valve annulus comprising

a body sized and configured to rest in net compression near or within a heart valve annulus, and

spaced-apart struts appended to the body to contact tissue near or within the heart valve annulus, the struts being sized and configured to displace tissue as a result of the net compression to reshape the heart valve annulus.

29. An implant according to claim 3 or 4 or 5 or 6

wherein at least one of the struts comprises a wire-form structure.

30. An implant according to claim 3 or 4 or 5 or 6

wherein the body and the struts each comprises a wire-form structure.

31. An implant according to claim 3 or 4 or 5 or 6

wherein at least one of the struts is collapsible onto the body.

32. An implant according to claim 3 or 4 or 5 or 6

wherein at least one of the struts carries a tissue in-growth material.

33. An implant according to claim 3 or 4 or 5 or 6

wherein at least one of the struts carries a structure sized and configured to increase a surface area of contact with tissue at, above, or below the annulus.

4. An implant to reshape a heart valve having an annulus and leaflet commissures comprising

a body sized and configured to rest in net compression near or within a heart valve annulus, and

spaced-apart struts appended to the body to contact tissue at or near the leaflet commissures, the struts being sized and configured to displace tissue as a result of the net compression to reshape the heart valve annulus.

5. An implant to reshape a heart valve annulus comprising

a body sized and configured to rest in net compression near or within a heart valve annulus, and

spaced-apart struts appended to the body to contact tissue near or within the heart valve annulus, the struts being sized and configured to apply tension to tissue as a result of the compression of the body to reshape the heart valve annulus.

39. A method for reshaping a heart valve annulus comprising the steps of

introducing an implant as defined in claim 5 into a heart, and

applying tension to reshape the heart valve annulus by locating the body of the implant as defined in claim 5 in net compression at or near a heart valve annulus with the struts in contact with and applying tension to tissue near or within the heart valve annulus.

41. A method according to claim 39 or 40

wherein the introducing step comprises using an open heart surgical procedure.

42. A method according to claim 39 or 40

wherein the introducing step comprises using a surgical procedure in which the implant is carried within a catheter.

43. A method according to claim 39 or 40

wherein the introducing step comprises using an intravascular surgical procedure.

44. A method according to claim 39 or 40

wherein the applying tension step comprises tethering the body of the implant as defined in claim 5 or 6, respectively, to at least one wire while locating the body in compression at or near a heart valve annulus.

6. An implant to reshape a heart valve having an annulus and leaflet commissures comprising

a body sized and configured to rest in net compression near or within the heart valve annulus, and

spaced-apart struts appended to the body to contact tissue at or near the leaflet commissures, the structures being sized and configured to apply tension to tissue at or near the leaflet commissures as a result of the compression of the body to shape and tension the heart valve annulus for leaflet coaptation.

40. A method for reshaping a heart valve having an annulus and leaflet commissures comprising the steps of

introducing an implant as defined in claim 6 into a heart, and

applying tension to shape and tension the heart valve annulus for leaflet coaptation by locating the body of the implant as defined in claim 6 in net compression at or near the leaflet commissures with the struts in contact with and applying tension to tissue at or near the leaflet commissures.