Implantation of repair chords in the heart

• US 8,808,368 B2
• Filed: 08/27/2009
• Issued: 08/19/2014
• Est. Priority Date: 12/22/2008
• 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:
  US12/548,991
• Publication Number:
  US 20100161042A1
• Time in Patent Office: 1,818 Days
• Field of Search: 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

A method is provided, including positioning, at an intraventricular site of a ventricle of a patient, a spool coupled to a first end portion of a longitudinal member and coupling a second end portion of the longitudinal member to a portion of tissue facing a lumen of the ventricle. Other embodiments are also described.

Claims

1. A method, comprising:

positioning, within a lumen of a ventricle of a heart of a patient at an intraventricular site of the ventricle selected from the group consisting of;

a papillary muscle and a portion of the inner wall of the ventricle of the patient, a spool coupled to a first end portion of a longitudinal member;

coupling a second end portion of the longitudinal member to a portion of tissue facing the lumen of the ventricle; and

rotating the spool, and by the rotating, adjusting a distance between the selected intraventricular site and the portion of tissue facing the lumen of the ventricle.

2. The method according to claim 1, wherein positioning the spool comprises transcatheterally advancing the spool toward the intraventricular site.

3. The method according to claim 1, wherein coupling the second end portion of the longitudinal member to the portion of tissue facing the ventricular lumen comprises coupling the second end portion of the longitudinal member to a leaflet of an atrioventricular valve of the patient.

4. The method according to claim 1, wherein positioning the spool comprises implanting the spool within the lumen of the ventricle at the intraventricular site.

5. The method according to claim 4, wherein implanting the spool within the lumen of the ventricle at the intraventricular site comprises suturing the spool to tissue within the intraventricular site.

6. The method according to claim 4, wherein the spool is coupled to a tissue anchor, and wherein implanting the spool within the lumen of the ventricle at the intraventricular site comprises implanting the tissue anchor in tissue of the ventricle such that a distal end of the tissue anchor is disposed within the tissue of the ventricle and does not extend beyond a pericardium of the heart of the patient.

7. The method according to claim 4,

wherein the portion of tissue facing the lumen of the ventricle includes a portion of at least one leaflet of an atrioventricular valve of the patient,

wherein the longitudinal member is an artificial chorda tendinea, a first end portion of the artificial chorda tendinea defining the first end portion of the longitudinal member, and wherein the spool is coupled to the first end portion of the artificial chorda tendinea, and

wherein implanting the spool comprises:

advancing, between leaflets of the atrioventricular valve and into the ventricle, at least a shaft of a delivery tool, to which shaft the spool is removably coupled, and implanting the spool within the intraventricular site; and

while the shaft remains coupled to the spool after implanting the spool, coupling, using a coupling element holder of the delivery tool, at least one leaflet-engaging element to the portion of the at least one leaflet, wherein a second end portion of the artificial chorda tendinea is coupled to the at least one leaflet-engaging element, the second end portion of the artificial chorda tendineae defining the second end portion of the longitudinal member.

8. The method according to claim 7, wherein implanting the spool within the lumen of the ventricle at the intraventricular site comprises implanting the spool at the papillary muscle of the ventricle of the patient.

9. The method according to claim 7, wherein implanting the spool within the lumen of the ventricle at the intraventricular site comprises implanting the spool at the portion of the inner wall of the ventricle of the patient.

10. The method according to claim 7, wherein coupling the at least one leaflet-engaging element to the portion of the at least one leaflet comprises coupling the at least one leaflet-engaging element to exactly one leaflet.

11. The method according to claim 7, wherein coupling the at least one leaflet-engaging element to the portion of the at least one leaflet while the shaft remains coupled to the spool comprises using the shaft to provide a reference force to the leaflet-engaging element.

12. The method according to claim 7, wherein using the coupling element holder of the delivery tool comprises sliding the coupling element holder with respect to the shaft.

13. The method according to claim 7, wherein the at least one leaflet-engaging element is a butterfly clip, which includes a plurality of petals arranged around a needle, and wherein coupling 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.

14. The method according to claim 7, further comprising adjusting, from a site outside of a body of the patient, a length of the artificial chorda tendinea.

15. The method according to claim 7, wherein the at least one leaflet-engaging element is a clip, and wherein coupling comprises clamping the clip on the at least one leaflet such that the clip engages atrial and ventricular surfaces of the leaflet.

16. The method according to claim 15, wherein the clip includes two clip jaws, and wherein clamping comprises holding the clip jaws within respective tool jaws of the coupling element holder, and opening and closing the clip jaws using the tool jaws.

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

18. The method according to claim 17, wherein coupling the non-continuous ring to the at least one leaflet 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 at least one 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 at least one leaflet.

19. The method according to claim 7, wherein the at least one leaflet-engaging element is at least one hook, and wherein coupling comprises puncturing the at least one leaflet with the at least one hook.

20. The method according to claim 19, wherein puncturing the at least one leaflet with the at least one hook comprises sliding the at least one hook proximally to an atrial surface of the at least one leaflet and subsequently puncturing the leaflet by sliding the at least one hook distally.

21. The method according to claim 19, wherein puncturing the at least one leaflet comprises sliding the at least one hook proximally to an atrial surface of the leaflet and allowing the at least one leaflet to engage the at least one hook responsively to beating of the leaflet.

22. The method according to claim 1,

wherein adjusting the distance comprises:

by the rotating of the spool, winding a portion of the longitudinal member around the spool,

by the winding of the portion, shortening a length of the longitudinal member, and

by the shortening of the length of the longitudinal member, drawing together the selected intraventricular site and the portion of tissue facing the lumen of the ventricle.

23. The method according to claim 22, wherein adjusting comprises adjusting, from a site outside of a body of the patient, the length of the longitudinal member.

24. The method according to claim 22,

wherein positioning the spool within the lumen of the ventricle of the heart of the patient at the intraventricular site comprises implanting the spool at a first portion of the inner wall of the ventricle of the patient,

wherein coupling the second end portion of the longitudinal member to the portion of tissue comprises coupling the second end portion of the longitudinal member to a second portion of the inner wall of the ventricle of the patient, and

wherein drawing together the selected intraventricular site and the portion of tissue facing the lumen of the ventricle comprises drawing the first and second portions of tissue of the inner wall of the ventricle toward one another.

25. The method according to claim 22, wherein the longitudinal member defines a first longitudinal member, wherein positioning the spool coupled to the first end portion of the longitudinal member comprises positioning a spool coupled to at least the first longitudinal member and to at least a second longitudinal member at respective first end portions thereof, each longitudinal member having respective second end portions thereof, wherein coupling the second end portion of the longitudinal member to the portion of tissue facing the lumen of the ventricle comprises coupling the second end portion of the first longitudinal member to a first portion of heart tissue facing the ventricular lumen, and wherein the method further comprises:

coupling the second end portion of the second longitudinal member to a second portion of heart tissue facing the ventricular lumen; and

drawing the first and second portions of heart tissue toward one another.

26. The method according to claim 1, further comprising advancing the spool toward the intraventricular site by advancing a portion of a delivery tool that is reversibly coupled to the spool between leaflets of an atrioventricular valve having at least first and second leaflets thereof, and wherein positioning the spool within the lumen of the ventricle at the intraventricular site comprises manipulating the delivery tool to position the spool within the lumen of the ventricle at the intraventricular site.

27. The method according to claim 26, further comprising, after positioning the spool:

decoupling the delivery tool from the spool,

removing the delivery tool from the ventricle, and

subsequently to the removing, accessing the spool at the intraventricular site.

28. The method according to claim 27, wherein accessing the spool comprises recoupling the delivery tool to the spool by advancing the delivery tool along at least one guide wire coupled to the spool.

29. The method according to claim 27, wherein accessing the spool comprises coupling a torque-delivering tool to the spool by advancing the torque-delivering tool through an elongate tube coupled at a first end thereof to the spool and at a second end thereof configured to be coupled to a portion of subcutaneous tissue of the patient.

30. The method according to claim 26, further comprising, after coupling the second end portion of the longitudinal member to the portion of tissue facing the ventricular lumen:

sliding a shaft of the delivery tool with respect to a torque-delivering tool of the delivery tool, and sliding a proximal portion of the shaft into a lumen of a handle portion of the delivery tool; and

subsequently to the sliding, rotating the spool.

31. The method according to claim 30, wherein sliding the shaft comprises:

sliding the shaft until a distal portion of the shaft is disposed proximally to the atrioventricular valve, and

responsively, reducing a diameter of the portion of the delivery tool disposed between the leaflets of the valve.

32. The method according to claim 31, wherein reducing the diameter of the portion of the delivery tool disposed between the leaflets of the valve comprises reducing the diameter to between 0.8 mm and 1.5 mm.

33. The method according to claim 1,

wherein positioning the spool comprises positioning the spool coupled to a mechanical locking element having a surface coupled to a lower surface of the spool, and

wherein the method further comprises:

advancing an elongate tool through a channel provided by the spool;

unlocking the spool from the mechanical locking element by pushing a depressible portion of the surface of the locking element;

responsively to the pushing of the depressible portion, dislodging a protrusion protruding out of a plane of the surface of the mechanical element from within a recess defined by the spool; and

rotating the spool.

34. The method according to claim 33,

wherein, during a first period:

pushing the depressible portion comprises maintaining the protrusion in a position in which it is dislodged from the recess; and

rotating the spool;

wherein the method further comprises, during a second period;

removing the elongate tool from within the channel and facilitating positioning of the protrusion in the recess; and

restricting rotation of the spool.