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

• US 20040260393A1
• Filed: 05/14/2004
• Published: 12/23/2004
• Est. Priority Date: 09/20/2000
• Status: Active Grant

• Current Assignee: MVRx, Inc.
• Original Assignee: Ample Medical, Inc. (MVRx, Inc.)
• Inventors: Machold, Timothy R., Rahdert, David A., Chang, Robert T., Macoviak, John A.
• Granted Patent: US 8,784,482 B2
• Time in Patent Office: Days
• US Class Current: 623/2.36
• CPC Class Codes: A61B 17/00234 for minimally invasive surgery A61B17/0218, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence
• CPC Class Codes: A61B 17/0401 Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors A61B17/0642 takes precedence; fixation devices for tendons or ligaments A61F2/0811
• CPC Class Codes: A61B 17/064 Surgical staples, i.e. penetrating the tissue
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/00783 Valvuloplasty
• CPC Class Codes: A61B 2017/00876 magnetic
• CPC Class Codes: A61B 2017/0412 having anchoring barbs or pins extending outwardly from suture anchor body
• CPC Class Codes: A61B 2017/0414 having a suture-receiving opening, e.g. lateral opening lateral eyelet for attaching suture to needle A61B2017/06019
• CPC Class Codes: A61B 2017/0417 T-fasteners
• CPC Class Codes: A61B 2017/0419 H-fasteners
• CPC Class Codes: A61B 2017/0427 having anchoring barbs or pins extending outwardly from the anchor body
• CPC Class Codes: A61B 2017/0437 the barbs being resilient or spring-like
• CPC Class Codes: A61B 2017/0464 for soft tissue
• CPC Class Codes: A61B 2017/0496 for tensioning sutures
• CPC Class Codes: A61B 2017/0641 having at least three legs as part of one single body
• CPC Class Codes: A61B 2017/0647 having one single leg, e.g. tacks
• CPC Class Codes: A61F 2/2445 Annuloplasty rings in direct contact with the valve annulus
• CPC Class Codes: A61F 2002/30079 magnetic
• CPC Class Codes: A61F 2210/009 magnetic
• CPC Class Codes: Y10S 623/904 Heart

Abstract

Devices, systems, and methods employ an implant that is sized and configured to attach in, on, or near the annulus of a dysfunctional heart valve. In use, the implant extends either across the minor axis of the annulus, or across the major axis of the annulus, or both. 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.

Claims

1. An implant system to affect a shape of a heart valve annulus comprising a first component sized and configured to engage tissue along a major axis of the annulus and a second component sized and configured, concurrent with the first component, to engage and inwardly displace tissue along a minor axis of the annulus.

2. An implant system according to claim 1, wherein the first component is sized and configured to outwardly displace along the major axis.

3. An implant system according to claim 1, wherein the first component is sized and configured to inwardly displace tissue along the major axis.

4. An implant system according to claim 1, wherein the first component is sized and configured to stabilize tissue along the major axis.

5. An implant system according to claim 1, wherein the first and second components comprise separate components.

6. An implant system according to claim 1, wherein the first and second components comprise an integrated body.

7. An implant according to claim 1, wherein the first component is sized and configured to engage tissue while in compression.

8. An implant according to claim 1, wherein the second component is sized and configured to engage tissue while in tension.

9. An implant according to claim 1, wherein the first component is sized and configured to engage tissue while in compression, and wherein the second component is sized and configured to engage tissue while in tension.

10. An implant according to claim 1, wherein at least one of the first and second components comprises a wire-form structure.

11. An implant according to claim 1, wherein at both of the first and second components comprise wire-form structures.

12. An implant according to claim 1, wherein at least one of the first and second components is collapsible for placement within a catheter.

13. An implant according to claim 1, wherein both of the first and second components are collapsible for placement within a catheter.

14. An implant system according to claim 1, wherein the first component comprises an elastic material.

15. An implant system according to claim 1, wherein the first component includes a fixation element that engages tissue at, near, or in a leaflet commissure of the annulus.

16. An implant system according to claim 1, wherein the first component includes a fixation element that engages tissue above and near a leaflet commissure of the annulus.

17. An implant system according to claim 1, wherein the second component comprises an elastic material.

18. An implant system according to claim 1, wherein the second component includes a fixation element that engages tissue at, near, or in the annulus.

19. An implant system according to claim 1, wherein the second component includes a fixation element that engages tissue above and near the annulus.

46. A method of treating a heart valve annulus having a major and minor axis comprising providing an implant system as defined in claim 1, placing the first component into engagement with tissue along the major axis, and placing the second component into engagement with tissue along the minor axis.

20. An implant to affect a shape of a heart valve annulus comprising a body including a first portion sized and configured to rest within a heart chamber near or within a heart valve annulus and a second portion joined to the first portion and sized and configured to extend through a septum to rest in another heart chamber.

21. An implant according to claim 20, wherein the body is generally aligned with a major axis of the annulus.

22. An implant according to claim 21, wherein the body outwardly displaces tissue to lengthen the major axis.

23. An implant according to claim 21, wherein the body inwardly displaces tissue to shorten the major axis.

24. An implant according to claim 21, wherein the body stablizes tissue adjacent the heart valve annulus.

25. An implant according to claim 20, wherein the body is generally aligned with a minor axis of the annulus.

26. An implant according to claim 25, wherein the body inwardly displaces tissue to shorten the minor axis.

27. An implant according to claim 25, wherein the body stabilizes tissue adjacent the heart valve annulus.

28. An implant according to claim 20, wherein the second portion includes a fixation element at or near the septum.

29. An implant according to claim 20, wherein the body comprises a wire-form structure.

30. An implant according to claim 20, wherein the body is collapsible for placement within a catheter.

31. An implant system according to claim 20, wherein the body comprises an elastic material.

32. An implant system according to claim 20, wherein the first portion includes a fixation element that engages tissue at, near, or in the annulus.

33. An implant system according to claim 20, wherein the first portion includes a fixation element that engages tissue above and near the annulus.

47. A method of treating a heart valve annulus comprising providing an implant as defined in claim 20, placing the first portion near or within the heart valve annulus, and placing the second portion through the septum at rest in another heart valve chamber.

34. An implant system to affect a shape of a heart valve annulus comprising a first magnetic or ferromagnetic component sized and configured to rest in tissue at or near a heart valve annulus and a second magnetic component sized and configured to rest in tissue at or near the heart valve annulus spaced from the first component, the first and second components generating between them a magnetic field.

35. An implant system according to claim 34, wherein the first and second components comprise opposing magnetic poles that generate an attracting magnetic field.

36. An implant system according to claim 34, wherein the first component comprises a soft ferromagnet material that is attracted to the second magnetic component.

37. An implant system according to claim 34, wherein the first and second components comprise like magnetic poles that generate a repelling magnetic field.

38. An implant system according to claim 34, wherein the first and second components occupy the same heart chamber.

39. An implant system according to claim 34, wherein the first and second components occupy different heart chambers.

40. An implant system according to claim 34, wherein one of the first and second components occupies a coronary sinus.

41. An implant system according to claim 34, wherein at least one of the first and second components comprises a leaflet retaining element.

48. A method of treating a heart valve annulus comprising providing an implant system as defined in claim 34, placing the first component in tissue at or near the heart valve annulus, and placing the second component in tissue at or near the heart valve annulus spaced from the first component sufficient to generate a magnetic field between the first and second components.

42. An implant comprising a body including a magnetic or ferromagnetic material that is sized and configured to rest in tissue at or near a heart valve annulus, the body including a leaflet retaining element.

49. A method of treating a heart valve annulus comprising providing an implant as defined in claim 42, and placing the body in tissue at or near a heart valve annulus so that the leaflet retaining element is located adjacent a heart valve leaflet.

43. An implant comprising a body sized and configured to rest near or within an annulus of a heart valve having leaflet commissures, the body including spaced-apart struts appended to the body to contact tissue at or near the leaflet commissures, the struts including elastic jaws that exert pulling forces on tissue at or near the commissures to squeeze the annulus together at the commissures to promote leaflet coaptation.

44. An implant according to claim 43, wherein at least one of the body, the struts, and the jaws comprises a wire-form structure.

45. An implant according to claim 43, wherein the body, the struts, and the jaws are collapsible for placement within a catheter.

50. A method of treating a heart valve annulus comprising providing an implant as defined in claim 43, placing the struts at or near the leaflet commissures, and placing the elastic jaws in contact with tissue at or near the commissures to squeeze the annulus together at the commissures.