METHOD FOR GUIDE-WIRE BASED ADVANCEMENT OF A ROTATION ASSEMBLY

• US 20110301698A1
• Filed: 06/07/2010
• Published: 12/08/2011
• Est. Priority Date: 10/29/2009
• Status: Active Grant

• Current Assignee: Valtech Cardio Ltd (Edwards Lifesciences Corporation)
• Original Assignee: Valtech Cardio Ltd (Edwards Lifesciences Corporation)
• Inventors: MILLER, Eran, Cabiri, Oz
• Granted Patent: US 8,690,939 B2
• Time in Patent Office: Days
• US Class Current: 623/2.1
• 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 2017/00243 cardiac
• CPC Class Codes: A61B 2017/0441 the shaft being a rigid coil or spiral
• CPC Class Codes: A61B 2017/0464 for soft tissue
• CPC Class Codes: A61B 2017/0496 for tensioning sutures
• CPC Class Codes: A61F 2/2442 Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
• 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

Abstract

A method is provided including coupling a tissue-engaging element to a first portion of cardiac tissue of a heart of a patient and advancing toward the tissue-engaging element an adjustment mechanism along at least one guide member that is removably coupled to the tissue-engaging element. The adjustment mechanism engages a first portion of a first flexible longitudinal member. A second portion of the first flexible longitudinal member is coupled to a second portion of cardiac tissue. Following the coupling of the second portion of the first flexible longitudinal member to the second portion of cardiac tissue, the adjustment mechanism is slid further along the guide member and coupled to the tissue-engaging element. Using the adjustment mechanism, a length of the first flexible longitudinal member is adjusted between the first and second portions of cardiac tissue. Other applications are also described.

Claims

1. A method comprising:

coupling a tissue-engaging element to a first portion of cardiac tissue of a heart of a patient;

advancing toward the tissue-engaging element an adjustment mechanism along at least a portion of at least one guide member that is removably coupled to the tissue-engaging element, the adjustment mechanism engaging at least a first portion of at least a first flexible longitudinal member;

coupling a second portion of the first flexible longitudinal member to a second portion of cardiac tissue;

following the coupling of the second portion of the first flexible longitudinal member to the second portion of cardiac tissue;

sliding the adjustment mechanism further along the guide member; and

coupling the adjustment mechanism to the tissue-engaging element; and

using the adjustment mechanism, adjusting a length of the first flexible longitudinal member between the first and second portions of cardiac tissue.

2. The method according to claim 1, wherein coupling the tissue-engaging element to the first portion of cardiac tissue comprises coupling the tissue-engaging element to a papillary muscle of a ventricle of the patient.

3. The method according to claim 1, wherein coupling the tissue-engaging element to the first portion of cardiac tissue comprises coupling the tissue-engaging element to a portion of an inner wall of a ventricle of the patient.

4. The method according to claim 1, wherein adjusting the length of the flexible longitudinal member comprises adjusting a distance between the first and second portions of cardiac tissue.

5. The method according to claim 1, wherein adjusting the length of the flexible longitudinal member comprises adjusting the length of the flexible longitudinal member during beating of the heart of the patient.

6. The method according to claim 1, wherein adjusting the length of the flexible longitudinal member comprises adjusting the length of the flexible longitudinal member during a first period thereof, and wherein the method further comprises further adjusting the length of the flexible longitudinal member during a second period that is after the first period.

7. The method according to claim 1, wherein coupling the tissue-engaging element to the first portion of cardiac tissue comprises coupling the tissue-engaging element to an intracardiac portion of tissue in a manner in which a distal portion of the tissue-engaging element does not extend beyond an epicardium of the heart of the patient.

8. The method according to claim 1, wherein coupling the second portion of the flexible longitudinal member to the second portion of cardiac tissue comprises coupling the second portion of the flexible longitudinal member to at least one leaflet of an atrioventricular valve of the patient.

9. The method according to claim 1, wherein coupling the second portion of the flexible longitudinal member to the second portion of cardiac tissue comprises coupling the second portion of the flexible longitudinal member to exactly one leaflet of an atrioventricular valve of the patient.

10. The method according to claim 1, wherein coupling the second portion of the flexible longitudinal member to the second portion of cardiac tissue comprises coupling, to a leaflet of an atrioventricular valve, a clip that is coupled to the second portion of the flexible longitudinal member.

11. The method according to claim 1, wherein coupling the adjustment mechanism to the tissue-engaging element comprises locking the adjustment mechanism to a docking station coupled to the tissue-engaging element.

12. The method according to claim 1, wherein advancing the adjustment mechanism comprises transcatheterally advancing the adjustment mechanism.

13. The method according to claim 1, wherein advancing the adjustment mechanism comprises threading the guide member through an opening in the adjustment mechanism prior to the advancing.

14. The method according to claim 1, further comprising:

advancing a first portion of a second flexible longitudinal member, toward the tissue-engaging element; and

coupling a second portion of the second flexible longitudinal member to a third portion of cardiac tissue.

15. The method according to claim 14, further comprising coupling the first portion of the second flexible longitudinal member to the tissue-engaging element following the coupling of the second portion of the second flexible longitudinal member to the third portion of cardiac tissue.

16. The method according to claim 14, wherein:

the second portion of cardiac tissue includes a portion of tissue of a ventricle of the patient,

coupling the second portion of the first flexible longitudinal member to the second portion of cardiac tissue comprises coupling the second portion of the first flexible longitudinal member to the portion of tissue of the ventricle of the patient,

the third portion of cardiac tissue includes at least one leaflet of an atrioventricular valve of the heart of the patient, and

coupling the second portion of the second flexible longitudinal member to the third portion of cardiac tissue comprises coupling the second portion of the second flexible longitudinal member to the at least one leaflet of the atrioventricular valve.

17. The method according to claim 1, wherein coupling the tissue-engaging element to the first portion of tissue comprises coupling a tissue-engaging element coupled to at least first and second docking stations, the first and second docking stations being removably coupled to first and second guide members, respectively.

18. The method according to claim 17, wherein:

advancing the adjustment mechanism comprises;

advancing a first adjustment mechanism along the first guide member, the first adjustment mechanism engaging at least a first portion of at least a first flexible longitudinal member; and

coupling the first adjustment mechanism to the first docking station, and the method further comprises;

advancing a second adjustment mechanism along the second guide member, the second adjustment mechanism engaging at least a first portion of at least a second flexible longitudinal member; and

coupling the second adjustment mechanism to the second docking station.

19. The method according to claim 18, wherein coupling the second portion of the flexible longitudinal member to the second portion of cardiac tissue comprises coupling a second portion of the first flexible longitudinal member to the second portion of cardiac tissue, and wherein the method further comprises coupling a second portion of the second flexible longitudinal member to a third portion of cardiac tissue.

20. The method according to claim 19, wherein:

the second portion of cardiac tissue includes a portion of tissue of a ventricle of the patient,

coupling the second portion of the first flexible longitudinal member to the second portion of cardiac tissue comprises coupling the second portion of the first flexible longitudinal member to the portion of tissue of the ventricle of the patient,

the third portion of cardiac tissue includes at least one leaflet of an atrioventricular valve of the heart of the patient, and

coupling the second portion of the second flexible longitudinal member to the third portion of cardiac tissue comprises coupling the second portion of the second flexible longitudinal member to the at least one leaflet of the atrioventricular valve.

21. The method according to claim 1, wherein coupling the second portion of the flexible longitudinal member to the second portion of cardiac tissue comprises coupling the second portion of the flexible longitudinal member to a portion of a wall of a ventricle of the patient, and wherein adjusting the length of the flexible member comprises adjusting a distance between the portion of the wall and the first portion of cardiac tissue.

22. The method according to claim 21, wherein adjusting the distance between the portion of the wall and the first portion of cardiac tissue comprises adjusting a malpositioning of the heart wall of the patient.

23. The method according to claim 1, wherein the adjustment mechanism includes a spool coupled to the first portion of the flexible longitudinal member, and wherein adjusting the length of the flexible longitudinal member using the adjustment mechanism comprises rotating the spool.

24. The method according to claim 23, further comprising unwinding a portion of the at least one flexible longitudinal member from around the spool, and wherein adjusting the length of the flexible longitudinal member comprises applying tension to the flexible longitudinal member subsequently to the unwinding.

25. The method according to claim 23, wherein adjusting the length of the flexible longitudinal member comprises:

applying tension to the flexible longitudinal member by winding successive portions of the flexible longitudinal member around the spool by rotating the spool in a first rotational direction thereof, and

slackening the flexible longitudinal member by unwinding the successive portions of the flexible longitudinal member from around the spool by rotating the spool in a second rotational direction thereof opposite the first rotational direction.

26. The method according to claim 23, further comprising unlocking the spool prior to the adjusting the length of the flexible longitudinal member, and locking the spool following the adjusting the length of the flexible longitudinal member.

27. The method according to claim 1, wherein:

the second portion of tissue includes at least one leaflet of an atrioventricular valve of the patient,

the longitudinal member comprises an artificial chordea tendinea, and

coupling the adjustment mechanism to the tissue-engaging element comprises;

advancing, between leaflets of the atrioventricular valve and into the ventricle, at least one shaft of a delivery tool, to which shaft the adjustment mechanism is removably coupled; and

while the shaft remains coupled to the adjustment mechanism, coupling, using a coupling element holder of the delivery tool, at least one leaflet-engaging element to the at least one leaflet, wherein the second portion of the artificial chordea tendinea is coupled to the at least one leaflet-engaging element.

28. The method according to claim 27, wherein advancing the at least one shaft comprises transcatheterally advancing the at least one shaft.

29. The method according to claim 27, wherein coupling the at least one leaflet-engaging element to the at least one leaflet comprises coupling the at least one leaflet-engaging element to exactly one leaflet.

30. The method according to claim 27, wherein using the coupling element holder of the delivery tool comprises sliding the coupling element holder with respect to the guide member.

31. The method according to claim 1, wherein:

the at least one flexible longitudinal member includes first and second cord portions thereof, each of the first and second cord portions having respective free ends,

the first and second cord portions of the flexible longitudinal member extend from the adjustment mechanism, and

coupling the second portion of the flexible longitudinal member to the second portion of cardiac tissue comprises coupling each free end of the first and second cord portions to respective first and second leaflets of an atrioventricular valve of the patient.

32. The method according to claim 31, wherein adjusting the length of the flexible longitudinal member comprises:

adjusting a length of the first cord portion of the longitudinal member between the adjustment mechanism and the first leaflet;

adjusting a length of the second cord portion of the longitudinal member between the adjustment mechanism and the second leaflet; and

by the adjusting the lengths of the first and second portions of the longitudinal member, drawing together the first and second leaflets.

33. The method according to claim 32, wherein drawing together comprises drawing together the first and second leaflets using a bead through which the first and second portions of the longitudinal member pass.

34. The method according to claim 33, wherein using the bead comprises advancing the bead to ventricular surfaces of the first and second leaflets, and wherein advancing the bead to the ventricular surfaces comprises creating an edge-to-edge repair of the first and second leaflets.

35. (canceled)

36. (canceled)

37. (canceled)

38. (canceled)