Implantation of repair chords in the heart

• US 8,500,800 B2
• Filed: 09/21/2009
• Issued: 08/06/2013
• Est. Priority Date: 05/04/2009
• Status: Active Grant

• Current Assignee: Valtech Cardio Ltd (Edwards Lifesciences Corporation)
• Original Assignee: Valtech Cardio Ltd (Edwards Lifesciences Corporation)
• Inventors: Maisano, Francesco, Miller, Eran, Cabiri, Oz, Herman, Yaron, Weitzman, Yoseph, Gross, Yossi
• Primary Examiner(s): TYSON, MELANIE RUANO
• Application Number:
  US12/563,930
• Publication Number:
  US 20100280603A1
• Time in Patent Office: 1,415 Days
• Field of Search: 623/2.1, 623/2.11, 623/23.72, 606139-150, 606/151, 606/213, 606/232
• US Class Current: 623/2.11
• 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 17/122 Clamps or clips , e.g. for the umbilical cord for the vas deferens A61F6/206
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/0406 Pledgets
• CPC Class Codes: A61B 2017/0409 Instruments for applying suture anchors for applying suture clamps, clips or locks A61B2017/0488
• 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 2017/0441 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 2/2457 Chordae tendineae prostheses
• CPC Class Codes: A61F 2/2466 Delivery devices therefor
• CPC Class Codes: A61F 2/2487 Devices within the heart chamber, e.g. splints
• CPC Class Codes: A61F 2250/0007 for adjusting length

Abstract

Apparatus for use with at least one leaflet-engaging element, the apparatus including a delivery tool which includes an inner shaft, a surrounding shaft, and at least one leaflet-engaging element holder coupled to a portion of the surrounding shaft, the leaflet-engaging-element holder being shaped to define at least one coupling site for reversibly coupling the leaflet-engaging element to the tool. The surrounding shaft surrounds a portion of the inner shaft and is slidable along the inner shaft so as to position the leaflet-engaging holder in a vicinity of at least one leaflet of an atrioventricular valve of a patient. A distal end of the inner shaft is advanceable between leaflets of the atrioventricular valve and toward a tissue site of a ventricle of the patient. Other applications are also described.

Claims

1. A method, comprising:

advancing a distal end of an inner shaft of a delivery tool between leaflets of an atrioventricular valve of a patient and to a tissue site of a ventricle of the patient, the distal end of the inner shaft being reversibly coupled to a tissue anchor, at least a portion of the inner shaft being surrounded by a surrounding shaft coupled at a portion thereof to at least one leaflet-engaging element holder, the leaflet-engaging-element holder being shaped to define at least one coupling site for reversibly coupling at least one leaflet-engaging element to the tool;

anchoring the tissue anchor at the tissue site using the distal end of the inner shaft;

sliding the surrounding shaft of the delivery tool with respect to the distal end of the inner shaft, in a manner in which a distal portion of the surrounding shaft moves toward the leaflets, and the leaflet-engaging holder is positioned in a vicinity of at least one leaflet of the atrioventricular valve;

using the surrounding shaft, engaging at least one of the leaflets with the at least one leaflet-engaging element; and

after engaging, proximally withdrawing the distal end of the inner shaft from within the ventricle.

2. The method according to claim 1, further comprising transcatheterally advancing the delivery tool toward the leaflets, and wherein advancing the distal end of the inner shaft comprises transcatheterally advancing the distal end of the inner shaft.

3. The method according to claim 1, wherein engaging the at least one leaflet comprises engaging exactly one leaflet.

4. The method according to claim 1, wherein the at least one leaflet-engaging element is a butterfly clip, which includes a plurality of petals arranged around a needle, and wherein engaging the at least one leaflet comprises penetrating the needle and petals through a ventricular surface of the at least one leaflet until the needle and petals emerge from an atrial surface of the at least one leaflet, and the petals unfold and couple the clip to the at least one leaflet.

5. The method according to claim 1, wherein the at least one leaflet-engaging element is a clip, and wherein engaging the at least one of the leaflets comprises clamping the leaflet in the clip such that the clip engages atrial and ventricular surfaces of the leaflet.

6. The method according to claim 5, wherein the clip includes two clip jaws, and wherein clamping comprises holding the clip jaws within respective tool jaws of the surrounding shaft, and opening and closing the clip jaws using the tool jaws.

7. The method according to claim 1, wherein the at least one leaflet-engaging element is a non-continuous ring, and wherein engaging the at least one of the leaflets comprises engaging one of the leaflets with the non-continuous ring.

8. The method according to claim 7, wherein engaging the leaflet with the non-continuous ring comprises initially holding the non-continuous ring in an extended position using a deforming rod, positioning the non-continuous ring in a vicinity of the leaflet, and thereafter separating the deforming rod from the non-continuous ring such that the non-continuous ring assumes an annular position coupled to the leaflet.

9. The method according to claim 1, wherein the at least one leaflet-engaging element is at least one hook, and wherein engaging the at least one of the leaflets comprises puncturing the leaflet with the at least one hook.

10. The method according to claim 9, wherein puncturing the leaflet with the at least one hook comprises sliding the at least one hook proximally to an atrial surface of the leaflet and subsequently puncturing the leaflet by sliding the at least one hook distally.

11. The method according to claim 9, wherein puncturing the leaflet comprises sliding the at least one hook proximally to an atrial surface of the leaflet and allowing the leaflet to engage the at least one hook responsively to beating of the leaflet.

12. The method according to claim 1, wherein the sliding and the engaging occurs while maintaining the distal end of the inner shaft at the tissue site, and wherein the sliding comprises proximally withdrawing the surrounding shaft of the delivery tool with respect to the distal end of the inner shaft.

13. The method according to claim 12, wherein maintaining the inner shaft at the tissue site comprises securing the distal end of the inner shaft to the tissue site.

14. The method according to claim 13, wherein engaging the at least one of the leaflets comprises utilizing stability of the at least one leaflet-engaging element provided by the securing of the distal end of the inner shaft to the tissue site.

15. Apparatus for use with a tissue anchor and at least one leaflet-engaging element, the apparatus comprising:

a delivery tool which comprises;

an inner shaft;

a surrounding shaft; and

at least one leaflet-engaging element holder coupled to a portion of the surrounding shaft, the leaflet-engaging-element holder being shaped to define at least one coupling site for reversibly coupling the at least one leaflet-engaging element to the tool, wherein;

the surrounding shaft surrounds a portion of the inner shaft and is slidable along the inner shaft so as to position the leaflet-engaging element holder in a vicinity of at least one leaflet of an atrioventricular valve of a patient, and

a distal end of the inner shaft is (1) advanceable between leaflets of the atrioventricular valve and toward a tissue site of a ventricle of the patient, and (2) reversibly couplable to the tissue anchor.

16. The apparatus according to claim 15, further comprising a catheter, wherein the delivery tool is advanceable within the catheter.

17. The apparatus according to claim 15, wherein the surrounding shaft is configured to facilitate engaging of the at least one leaflet by sliding with respect to the distal end of the inner shaft.

18. The apparatus according to claim 15, further comprising the at least one leaflet-engaging element, and wherein the surrounding shaft is configured to engage facilitate engaging of exactly one of the leaflets with the at least one leaflet-engaging element.

19. The apparatus according to claim 15, wherein the tissue site includes tissue of an intraventricular site of the ventricle of the patient, and wherein the distal end of the inner shaft is configured to be coupled to tissue of the ventricle at the intraventricular site.

20. The apparatus according to claim 15, further comprising the at least one leaflet-engaging element, and wherein the at least one leaflet-engaging element comprises a butterfly clip, which comprises a plurality of petals arranged around a needle, which needle and petals are configured to penetrate through a ventricular surface of the at least one leaflet until the needle and petals emerge from an atrial surface of the at least one leaflet, and the petals unfold and couple the clip to the at least one leaflet.

21. The apparatus according to claim 15, further comprising the at least one leaflet-engaging element, and wherein the at least one leaflet-engaging element comprises at least one hook, which is configured to puncture the at least one leaflet.

22. The apparatus according to claim 15, further comprising the at least one leaflet-engaging element, and wherein the at least one leaflet-engaging element comprises at least one clip, which is configured to engage atrial and ventricular surfaces of the at least one leaflet.

23. The apparatus according to claim 22, wherein the clip comprises two clip jaws, and wherein the surrounding shaft comprises two tool jaws, which are configured to hold the two clip jaws, respectively, and to open and close the clip jaws.

24. The apparatus according to claim 15, further comprising the at least one leaflet-engaging element, and wherein the at least one leaflet-engaging element comprises at least one non-continuous ring, which is configured to be coupled to the at least one leaflet.

25. The apparatus according to claim 24, wherein the delivery tool further comprises a deforming rod, which is configured to initially hold the non-continuous ring an in extended position.

26. The apparatus according to claim 15, further comprising:

the at least one leaflet-engaging element;

an implant assembly, which is reversibly couplable to the distal end of the inner shaft of the delivery tool, and which comprises;

the tissue anchor;

a spool; and

at least one artificial chorda tendinea, which has opposite first and second end portions, which first end portion is coupled to the spool, and which second end portion is coupled to the at least one leaflet-engaging element; and

wherein the inner shaft of the delivery tool is configured to be removably coupled to the spool, and to couple the spool at an intraventricular site of the ventricle.

27. The apparatus according to claim 26, wherein the spool is implantable at the intraventricular site of the ventricle such that the spool is disposed within a ventricular lumen of the ventricle and at least a portion of the spool does not extend beyond a pericardium of a heart of the patient.

28. The apparatus according to claim 26, wherein the at least one artificial chorda tendinea and the spool are configured such that rotation of the spool winds the at least one artificial chorda tendinea around the spool, thereby drawing the at least one leaflet-engaging element toward the spool.

29. The apparatus according to claim 28, wherein the delivery tool further comprises a torque-delivering tool, wherein the inner shaft is shaped to define at least one lumen, and wherein the torque-delivering tool is disposed in the lumen and is configured to rotate the spool.

30. The apparatus according to claim 26, wherein the implant assembly further comprises a locking mechanism coupled to the spool and configured to restrict rotation of the spool.

31. The apparatus according to claim 26, wherein the delivery tool further comprises:

at least one guide wire coupled to the spool; and

a screwdriver housing, which is coupled to the inner shaft in a vicinity of a distal end thereof, and which is configured to be removably coupled to the spool and advanceable along the guide wire.

32. The apparatus according to claim 26, wherein the at least one artificial chorda tendinea is configured such that a length thereof is adjustable from a site outside of a body of the patient.

33. The apparatus according to claim 26,

wherein the at least one artificial chorda tendinea comprises first and second artificial chordae tendineae having respective first and second end portions,

wherein the spool is coupled to the first end portions of the first and second artificial chordae tendineae,

wherein the at least one leaflet-engaging element comprises first and second leaflet-engaging elements, which are coupled to the second end portion of the first artificial chorda tendinea and the second end portion of the second artificial chorda tendinea, respectively, and

wherein the coupling element holder is configured to couple the first and second leaflet-engaging elements to respective first and second leaflets.

34. The apparatus according to claim 33, wherein the implant assembly further comprises a bead, through which the first and second artificial chordae tendineae pass.

35. The apparatus according to claim 26, wherein the coupling element holder is configured to facilitate coupling of the at least one leaflet-engaging element to exactly one leaflet.

36. The apparatus according to claim 26, wherein the inner shaft, while coupled to the spool, is configured to provide a stabilizing force to the coupling element holder while the coupling element holder couples the at least one leaflet-engaging element to the at least one leaflet.

37. The apparatus according to claim 15, wherein the surrounding shaft is configured to engage the at least one leaflet with the at least one leaflet-engaging element while the distal end of the inner shaft is maintained in a vicinity of the tissue site, and in the ventricle.

38. The apparatus according to claim 15, further comprising the at least one leaflet-engaging element, and wherein the at least one leaflet-engaging element comprises a needle.

39. Apparatus for use with a sheath, which is configured to be advanced into an atrium of a patient in a transcatheter procedure, the apparatus comprising:

an implant assembly, which is configured to be passed through the sheath, and which comprises;

at least one leaflet-engaging element;

an adjustment mechanism; and

at least one longitudinal member, which has opposite first and second end portions, which first end portion is coupled to the adjustment mechanism, and which second end portion is coupled to the at least one leaflet-engaging element; and

a delivery tool, which is configured to be passed through the sheath, and which comprises;

an inner shaft, which is configured to be advanced between leaflets of an atrioventricular valve of the patient and into a ventricle of the patient, and which is configured to be removably coupled to the adjustment mechanism, and to couple the adjustment mechanism at an intraventricular site of the ventricle;

a surrounding shaft, which surrounds a portion of the inner shaft, and is slidable with respect to the inner shaft; and

a coupling element holder, which is coupled to the surrounding shaft, and which is configured to couple the at least one leaflet-engaging element to at least one leaflet of the atrioventricular valve.

40. The apparatus according to claim 39, wherein the adjustment mechanism comprises a spool.

41. The apparatus according to claim 39, wherein the at least one longitudinal member comprises at least one artificial chorda tendinea.