IMPLANTATION OF REPAIR CHORDS IN THE HEART

• US 20100280603A1
• Filed: 09/21/2009
• Published: 11/04/2010
• 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: Cabiri, Oz, Maisano, Francesco, Gross, Yossi, Herman, Yaron, Miller, Eran, Weitzman, Yoseph
• Granted Patent: US 8,500,800 B2
• Time in Patent Office: Days
• 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
• CPC Class Codes: A61B 2017/0414 having a suture-receiving opening, e.g. lateral opening
• 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

A method is provided, including advancing a distal end of an inner shall of a delivery tool between leaflets of an atrioventricular valve, of a patient and into a ventricle of the patient. The method further includes, while maintaining the distal end of the inner shaft in place and within the ventricle, proximally withdrawing a surrounding shaft of the delivery tool with respect to the distal end of the inner shaft and toward the leaflets. This surrounding shaft surrounds a portion of the inner shaft. The method additionally includes using the surrounding shaft to engage at least one of the leaflets with at least one leaflet-engaging element. After engaging, the distal end of the inner shaft is proximally withdrawn from within the ventricle. 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, at least a portion of the inner shaft being surrounded by a surrounding shaft;

while maintaining the distal end of the inner shaft at the tissue site;

proximally withdrawing 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

using the surrounding shaft, engaging at least one of the leaflets with 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 maintaining the inner shaft at the tissue site comprises securing the distal end of the inner shaft to the tissue site.

4. The method according to claim 3, 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.

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

6. 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.

7. 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.

8. The method according to claim 7, 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.

9. 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.

10. The method according to claim 9, 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 lo the leaflet.

11. 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.

12. The method according to claim 11, 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.

13. The method according to claim 11, 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.

14. Apparatus, comprising:

at least one leaflet-engaging element; and

a delivery tool which comprises an inner shaft and a surrounding shaft that surrounds a portion of the inner shaft and is slidable along the inner shaft, a distal end of the inner shaft configured to be advanced between leaflets of an atrioventricular valve of a patient and to a tissue site of a ventricle of the patient.

wherein the surrounding shaft is configured to engage at least one of the leaflets with the at least one leaflet-engaging element while the distal end of the inner shaft is maintained at the tissue site.

15. The apparatus according to claim 14, further comprising a catheter, wherein the delivery tool is advanceable within the catheter.

16. The apparatus according to claim 14, wherein the surrounding shaft is configured to engage the at least one of the leaflets by sliding with respect to the distal end of the inner shaft.

17. The apparatus according to claim 14, wherein the surrounding shaft is configured to engage exactly one of the leaflets of the at least one leaflet-engaging element.

18. The apparatus according to claim 14, 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.

19. The apparatus according to claim 14, 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.

20. The apparatus according to claim 14, wherein the at least one leaflet-engaging element comprises at least one hook, which is configured to puncture the at least one of the leaflets.

21. The apparatus according to claim 14, 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 of the leaflets.

22. The apparatus according to claim 21, 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.

23. The apparatus according to claim 14, wherein the at least one leaflet-engaging element comprises at least one non-continuous ring, which is configured to be coupled to one of the leaflets.

24. The apparatus according to claim 23, wherein the delivery tool further comprises a deforming rod, which is configured to initially hold the non-continuous ring an in extended position.

25. The apparatus according to claim 14, further comprising:

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

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;

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; and

wherein the delivery tool further comprises 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.

26. The apparatus according to claim 25, wherein the spool is implantable at the intraventricular site of the ventricle such that the spool is disposed in 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.

27. The apparatus according to claim 25, 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.

28. The apparatus according to claim 27, wherein the delivery tool further comprises a torque-delivering tool, wherein the inner shaft is shaped to define al least one lumen, and wherein the torque-delivering tool is disposed in the lumen and is configured to rotate the spool.

29. The apparatus according to claim 25, wherein the implant assembly further comprises a locking mechanism coupled to the spool and configured to restrict rotation of the spool.

30. The apparatus according to claim 25, 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.

31. The apparatus according to claim 25, 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.

32. The apparatus according to claim 25,

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.

33. The apparatus according to claim 32, wherein the implant assembly further comprises a bead, through which the first and second artificial chordae tendineae pass.

34. The apparatus according to claim 25, wherein the coupling element holder is configured to couple the at least one leaflet-engaging element to exactly one leaflet.

35. The apparatus according to claim 25, wherein the inner shaft, while coupled lo 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.

36. Apparatus comprising:

a sheath, which is configured to be advanced into an atrium of a patient in a transcatheter procedure;

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

at least one leaflet-engaging element;

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

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

a 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 spool, and to couple the spool 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.

37. 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 into a ventricle of the patient, at least a portion of the inner shaft being surrounded by a surrounding shaft;

while not withdrawing the distal end of the inner shaft in a proximal direction;

proximally withdrawing 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

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

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