Cardiac devices and methods for minimally invasive repair of ischemic mitral regurgitation

• US 8,292,884 B2
• Filed: 08/01/2003
• Issued: 10/23/2012
• Est. Priority Date: 08/01/2002
• Status: Active Grant

• Current Assignee: The General Hospital Corporation (Mass General Brigham, Inc.)
• Original Assignee: The General Hospital Corporation (Mass General Brigham, Inc.)
• Inventors: Levine, Robert A., Messas, Emmanuel
• Primary Examiner(s): ROANE, AARON F
• Application Number:
  US10/523,096
• Publication Number:
  US 20060095025A1
• Time in Patent Office: 3,371 Days
• Field of Search: 128/898, 606167-185, 600/564
• US Class Current: 606/41
• 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 17/221 Gripping devices in the form of loops or baskets for gripping calculi or similar types of obstructions surgical snare instruments A61B17/32056
• 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 18/24 with a catheter A61B18/26, A61B18/28 take precedence
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/003 Steerable
• CPC Class Codes: A61B 2017/00349 Needle-like instruments having hook or barb-like gripping means, e.g. for grasping suture or tissue A61B17/06066 takes precedence
• CPC Class Codes: A61B 2017/00867 shape memory effect for prostheses A61F2210/0014
• CPC Class Codes: A61B 2017/22035 for retrieving or repositioning foreign objects
• CPC Class Codes: A61B 2017/32004 having a laterally movable cutting member at its most distal end which remains within the contours of said end
• CPC Class Codes: A61F 2/2457 Chordae tendineae prostheses

Abstract

Novel apparatus and minimally invasive methods to treat atrioventricular valve regurgitation that is a result of tethering of chordae attaching atrioventricular valve leaflets to muscles of the heart, such as papillary muscles and muscles in the heart wall, thereby restricting the closure of the leaflets. Catheter embodiments for delivering and positioning chordal severing and elongating instruments are described.

Claims

1. An apparatus for treating atrioventricular valve regurgitation, comprising:

a cutting arrangement configured to sever at least one chord attaching an atrioventricular leaflet to an internal cardiac muscle;

a positioning catheter configured to position the cutting arrangement proximate the at least one chord; and

a grasping arrangement which is configured to at least partially constrain a movement of the at least one chord relative to the catheter,

wherein the catheter comprises an opening provided within a side wall in which the grasping arrangement constrains the movement of the at least one chord and in which the cutting arrangement is configured to sever the at least one chord, wherein the grasping and cutting arrangements are provided in the catheter, wherein the grasping arrangement comprises a grasping member configured to slide along a longitudinal direction relative to an extension axis of the catheter, and wherein the grasping member comprises a wire.

2. The apparatus of claim 1, wherein the cutting instrument comprises a blade having a cutting edge width that is approximately the same size as a diameter of the at least one chord.

3. The apparatus of claim 1, wherein the cutting instrument comprises an optical fiber for delivering ablative laser energy.

4. The apparatus of claim 1, wherein the cutting instrument comprises a radiofrequency electrode.

5. The apparatus of claim 1, wherein the catheter has a curved end suitable to allow engagement of chords attached to a posterior leaflet.

6. The apparatus of claim 1, wherein the catheter includes a steerable tip.

7. The apparatus of claim 6, wherein the catheter further comprises coaxial steering wires for steering the catheter tip.

8. The apparatus of claim 1, wherein the opening comprises a notch in the catheter having a cross-sectional notch area greater than the cross-sectional area of the at least one chord.

9. The apparatus of claim 8, wherein the notch includes at least one protruding edge defining a portion of the notch for limiting motion of the at least one chord when positioned within the notch.

10. The apparatus of claim 1, further comprising an introducer catheter for advancing the positioning catheter toward the at least one chord.

11. The apparatus of claim 10, wherein the introducer catheter further comprises a directing arm through which the positioning catheter is maneuvered to the position proximate the at least one chord.

12. The apparatus of claim 10, wherein the introducer catheter further comprises a means for temporarily stabilizing the position of the introducer catheter within the LV.

13. The apparatus of claim 12, wherein the stabilization means comprises:

one or more contact elements reversibly extendable from the introducer catheter so as to contact an internal surface of the heart cavity at one or more points.

14. The apparatus of claim 13, wherein the contact element is composed of, a shape memory elastic material that assumes the shape desired upon extension from the introducer catheter.

15. The apparatus of claim 10, further comprising an ultrasound transducer for imaging a region proximate the at least one chord located on the introducer catheter.

16. The apparatus of claim 10,

wherein the positioning catheter protrudes from within the introducer catheter through an opening in the introducer catheter;

and

further comprising a plurality of positioning wires similarly disposed within and protruding from the introducer catheter, the positioning wires attached to the positioning catheter so as to enable steering of the end of the positioning catheter by selectively tensioning on one or more of the wires.

17. The apparatus of claim 10, wherein the introducer catheter further comprises an imaging device oriented so as to image a region near the mitral valve including the at least one chord.

18. The apparatus of claim 17, wherein the imaging device is comprised of a imager selected from the group consisting of a two-dimensional matrix array of piezoelectric crystals, a linear phased array and means for rotating the array within the catheter so as to produce a three-dimensional image, a magnetic resonance coil, and fiber optics for transmitting and receiving near infrared energy.

19. The apparatus of claim 1, wherein the cutting arrangement is further configured to sever at least one chord while the grasping arrangement is at least partially constraining a movement of the at least one chord.

20. The apparatus of claim 1, wherein a. distal end of the wire is curved.

21. The apparatus of claim 1, wherein a distal end of the wire comprises a hook-shaped portion.

22. The apparatus of claim 1, wherein the wire comprises a shape-memory material.

23. The apparatus of claim 1, wherein the grasping arrangement comprises at least one pincer member which is rotatably coupled to the catheter and which is configured to surround at least a portion of the at least one chord.

24. The apparatus of claim 1, wherein the grasping arrangement comprises at least two pincer members which are rotatably coupled to the catheter and which are configured to surround at least a portion of the at least one chord.

25. The apparatus of claim 1, further comprising a stabilizing arrangement configured to at least partially constrain a motion of the catheter relative to a location within a chamber of a heart and extend longitudinally past an edge of the catheter to contact a ventricle.

26. The apparatus of claim 25, wherein the stabilizing arrangement comprises an extendable member which is configured to contact the location within the chamber.

27. The apparatus of claim 26, wherein the stabilizing arrangement comprises a shape memory material.

28. The apparatus of claim 25, wherein the stabilizing arrangement is further configured to extend longitudinally to an apex of the ventricle with respect to an extension of the catheter.

29. The apparatus of claim 1, further comprising a second catheter configured to advance the positioning catheter toward the at least one chord.

30. The apparatus of claim 1, wherein the grasping arrangement retracts the at least one chord into the catheter.

31. The apparatus of claim 30, wherein the grasping arrangement retracts the at least one chord into the opening of the catheter, and wherein the cutting arrangement severs the at least one chord.

32. The apparatus of claim 1, wherein the cutting arrangement is further configured to sever the at least one chord only within the opening.

33. The apparatus of claim 1 wherein the grasping arrangement and the cutting arrangement are longitudinally coupled to one another.

34. The apparatus of claim 1, wherein the cutting arrangement is further configured to move only approximately in parallel with respect to a motion of the grasping arrangement to facilitate the severing of the at least one chord in the opening.