Valve to myocardium tension members device and method

• US 8,226,711 B2
• Filed: 07/01/2005
• Issued: 07/24/2012
• Est. Priority Date: 12/17/1997
• Status: Expired due to Term

• Current Assignee: Edwards Lifesciences LLC (Edwards Lifesciences Corporation)
• Original Assignee: Edwards Lifesciences LLC (Edwards Lifesciences Corporation)
• Inventors: Mortier, Todd J., Schweich, Cyril J. Jr.
• Primary Examiner(s): Willse, David H.
• Application Number:
  US11/172,437
• Publication Number:
  US 20060052868A1
• Time in Patent Office: 2,580 Days
• Field of Search: 623/2.1, 623/2.36, 623/2.37, 623/3.1, 623/23.64, 623/904, 623/900, 600/37
• US Class Current: 623/2.36
• CPC Class Codes: A61B 2017/048 for reducing heart wall tension, e.g. sutures with a pad on each extremity
• CPC Class Codes: A61F 2/2445 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 2/2457 Chordae tendineae prostheses
• CPC Class Codes: A61F 2/2463 Implants forming part of the valve leaflets
• CPC Class Codes: A61F 2/2487 Devices within the heart chamber, e.g. splints
• CPC Class Codes: Y10S 623/90 Stent for heart valve

Abstract

A device for heart valve repair including at least one tension member having a first end and second end. A basal anchor is disposed at the first end of the tension member and a secondary anchor at the second end. The method includes the steps of anchoring the basal anchor proximate a heart valve and anchoring the secondary anchor at a location spaced from the valve such that the chamber geometry is altered to reduce heart wall tension and/or stress on the valve leaflets.

Claims

1. A method of treating an in situ mitral valve, comprising:

providing a valve repair device to be secured to a mitral valve annulus, the device including a basal anchor adapted to attach around at least a portion of the mitral valve annulus and having a pylon fixed thereto that extends through the mitral valve opening into the left ventricle associated with the mitral valve, the device further including tension members attached to the pylon within the left ventricle and each having a length sufficient to extend to a papillary muscle within the left ventricle, the device further including an anchor corresponding to each tension member for securing the tension member to the respective papillary muscle;

delivering the device to the mitral valve annulus;

anchoring the tension members to respective papillary muscles using the corresponding anchors;

securing the basal anchor to the mitral valve annulus; and

establishing tension in the tension members between the respective papillary muscles and the basal anchor.

2. The method of claim 1, wherein the basal anchor is crescent-shaped.

3. The method of claim 2, wherein the pylon is fixed to at least two points on the basal anchor and has a spanning portion that spans between the two points and across the mitral valve opening above the basal anchor, the pylon further including a descending portion that extends through the mitral valve opening into the left ventricle associated with the mitral valve and to which the tension members attach.

4. The method of claim 3, wherein the pylon further includes a perpendicular portion that bisects the spanning portion over the mitral valve opening and extends perpendicularly therefrom to a third point on the basal anchor, such that the descending portion is supported by a T-shaped structure over the mitral valve opening.

5. The method of claim 1, wherein establishing tension in the tension members reduces one or both of the transverse radius and vertical dimension of the left ventricle.

6. The method of claim 1, wherein establishing tension in the tension members draws the papillary muscles toward the basal anchor.

7. The method of claim 1, wherein the tension members are fixably attached to the basal anchor.

8. The method of claim 1, wherein the tension members are releasably attached to the basal anchor.

9. The method of claim 1, further including placing a transverse tension member across the ventricular cavity and between the papillary muscles to which the tension members anchor and establishing tension in the transverse tension member directly between the papillary muscles.

10. The method of claim 1, wherein the anchors for securing the tension members to the papillary muscles are transmural anchor pads.

11. The method of claim 1, wherein the anchors for securing the tension members to the papillary muscles are hook-shaped papillary muscle tissue loops.

12. The method of claim 1, wherein the anchors for securing the tension members to the papillary muscles are screw-shaped tissue anchors.

13. The method of claim 1, wherein the tension members are substantially flexible.

14. The method of claim 1, wherein the tension members are substantially rigid.

15. The method of claim 1, wherein securing the basal anchor to the mitral valve annulus comprises sewing the basal anchor to the mitral valve annulus.

16. The method of claim 15, wherein securing the basal anchor to the mitral valve annulus decreases the size of the annulus.

17. The method of claim 1, wherein the basal anchor is an annuloplasty ring.

18. A method of treating an in situ mitral valve, comprising:

providing a valve repair device to be secured to a mitral valve annulus, the device including a generally planar basal anchor adapted to attach around at least a portion of the mitral valve annulus and having a pylon fixed to at least two points on the basal anchor and having a spanning portion that spans between the two points and across the mitral valve opening above the planar basal anchor, the pylon further including a descending portion that extends through the mitral valve opening into the left ventricle associated with the mitral valve;

delivering the device to the mitral valve annulus;

tethering a distal end of the pylon descending portion within the left ventricle to a papillary muscle using a flexible elongate member;

securing the basal anchor to the mitral valve annulus; and

establishing tension in the flexible elongate member between the papillary muscle and the basal anchor.

19. The method of claim 18, wherein the basal anchor is crescent-shaped.

20. The method of claim 18, wherein the pylon further includes a perpendicular portion that bisects the spanning portion over the mitral valve opening and extends perpendicularly therefrom to a third point on the basal anchor, such that the descending portion is supported by a T-shaped structure over the mitral valve opening.

21. The method of claim 18, wherein establishing tension in the flexible elongate member reduces one or both of the transverse radius and vertical dimension of the left ventricle.

22. The method of claim 18, wherein establishing tension in the flexible elongate member draws the papillary muscle toward the basal anchor.

23. The method of claim 18, wherein the flexible elongate member is fixably attached to the basal anchor.

24. The method of claim 18, wherein the flexible elongate member is releasably attached to the basal anchor.

25. The method of claim 18, wherein there are two flexible elongate members attached to the pylon within the left ventricle and each having a length sufficient to extend to a papillary muscle within the left ventricle.

26. The method of claim 25, further including placing a transverse flexible elongate member across the ventricular cavity and between the papillary muscles to which the flexible elongate members anchor and establishing tension in the transverse flexible elongate member directly between the papillary muscles.

27. The method of claim 18, wherein the device further includes an anchor for securing the flexible elongate member to the papillary muscle.

28. The method of claim 27, wherein the anchor is a transmural anchor pad.

29. The method of claim 27, wherein the anchor is a hook-shaped papillary muscle tissue loop.

30. The method of claim 27, wherein the anchor is a screw-shaped tissue anchor.

31. The method of claim 18, wherein the flexible elongate member is substantially flexible.

32. The method of claim 18, wherein the flexible elongate member is substantially rigid.

33. The method of claim 18, wherein securing the basal anchor to the mitral valve annulus comprises sewing the basal anchor to the mitral valve annulus.

34. The method of claim 33, wherein securing the basal anchor to the mitral valve annulus decreases the size of the annulus.

35. The method of claim 18, wherein the basal anchor is an annuloplasty ring.