Delivery tool for implantation of spool assembly coupled to a helical anchor

• US 8,734,467 B2
• Filed: 12/02/2010
• Issued: 05/27/2014
• Est. Priority Date: 12/02/2009
• Status: Active Grant

• Current Assignee: Valtech Cardio Ltd (Edwards Lifesciences Corporation)
• Original Assignee: Valtech Cardio Ltd (Edwards Lifesciences Corporation)
• Inventors: Miller, Eran, Pomerantz, Uriel A., Maisano, Francesco, Cabiri, Oz, Herman, Yaron, Weitzman, Yoseph, Gross, Yossi
• Primary Examiner(s): McDermott, Corrine M
• Assistant Examiner(s): ORKIN, ALEXANDER J
• Application Number:
  US12/926,673
• Publication Number:
  US 20110282361A1
• Time in Patent Office: 1,272 Days
• Field of Search: 606/139, 606142-144, 606/232, 623/2.11
• US Class Current: 606/139
• 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 17/0469 Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery
• CPC Class Codes: A61B 2017/00243 cardiac
• 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 2017/044 with a threaded shaft, e.g. screws
• 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 2017/048 for reducing heart wall tension, e.g. sutures with a pad on each extremity
• CPC Class Codes: A61F 2/2427 Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: A61F 2/2457 Chordae tendineae prostheses
• CPC Class Codes: A61F 2/2466 Delivery devices therefor

Abstract

Apparatus is provided, including a tissue-adjusting member configured to be coupled to tissue of a patient, a rotatable structure that is configured to adjust a tension of the tissue-adjusting member, a tissue anchor coupled to the tissue-adjusting member and configured to screw into the tissue of the patient, and a delivery tool reversibly coupleable to the rotatable structure. The delivery tool comprises a first actuating element configured to rotate the tissue anchor so as to facilitate screwing of the tissue anchor into the tissue of the patient while not facilitating rotation of the rotatable structure, and a second actuating element configured to rotate the rotatable structure while not facilitating rotation of the tissue anchor. Other applications are also described.

Claims

1. Apparatus, comprising:

a tissue-adjusting member configured to be coupled to tissue of a patient, the tissue-adjusting member comprising a tissue-adjusting member selected from the group consisting of;

one or more artificial chordae tendineae and at least a portion of an annuloplasty ring structure, the tissue-adjusting member comprising;

a rotatable structure that is configured to adjust a tension of the tissue-adjusting member, in a manner in which during rotation of the rotatable structure in a first rotational direction in order to apply tension to the tissue-adjusting member, successive portions of the tissue-adjusting member advance with respect to and contact the rotatable structure;

a locking mechanism coupled to the rotatable structure, the locking mechanism being configured to restrict rotation of the rotatable structure; and

a tissue anchor coupled to the tissue-adjusting member and configured to screw into the tissue of the patient; and

a delivery tool reversibly coupleable to the rotatable structure, the delivery tool comprising;

at least a first actuating element configured to rotate the rotatable structure while not facilitating rotation of the tissue anchor; and

an elongate locking mechanism release which slides through a lumen of the tool in order to facilitate (1) locking of the rotatable structure to restrict rotation of the rotatable structure, and (2) maintaining the rotatable structure in an unlocked state in order to facilitate rotation of the rotatable structure by the first actuating element and thereby facilitate the applying of tension to the tissue-adjusting member.

2. The apparatus according to claim 1, wherein the delivery tool comprises a second actuating element, configured to rotate the tissue anchor so as to facilitate screwing of the tissue anchor into the tissue of the patient while not facilitating rotation of the rotatable structure.

3. The apparatus according to claim 2, wherein the tissue anchor comprises a helical tissue anchor.

4. The apparatus according to claim 2, wherein:

the first actuating element comprises a first rotatable knob,

the second actuating element comprises a second rotatable knob,

the delivery tool has a longitudinal axis, and

the first and second rotatable knobs are configured to rotate about the longitudinal axis of the delivery tool.

5. The apparatus according to claim 4, further comprising a housing surrounding the rotatable structure, and wherein the tissue anchor is coupled to the housing in a manner in which the rotatable structure and the tissue anchor are disposed along the longitudinal axis of the delivery tool.

6. The apparatus according to claim 4, wherein the tissue anchor and the rotatable structure are disposed along the longitudinal axis of the delivery tool.

7. The apparatus according to claim 6, wherein the tissue anchor has a tissue-anchor-axis-of-rotation that is along the longitudinal axis of the delivery tool, wherein the rotatable structure has a rotatable-structure-axis-of-rotation that is along the longitudinal axis of the delivery tool, and wherein the tissue-anchor-axis-of-rotation and the rotatable-structure-axis-of-rotation are identical.

8. The apparatus according to claim 4, wherein the delivery tool comprises a first helical groove and a first pin, and wherein the first pin is mechanically coupled to the first rotatable knob and advanceable within the first helical groove.

9. The apparatus according to claim 8, wherein the delivery tool comprises a first cylindrical element that is shaped so as to define the first helical groove, and wherein the first rotatable knob is coupled to the first cylindrical element in a manner in which, during rotation of the first rotatable knob, the first cylindrical element is configured to rotate about the longitudinal axis of the delivery tool, and the first helical groove advances helically with respect to the first pin.

10. The apparatus according to claim 9, wherein the first pin is coupled to a slidable numerical indicator, and wherein, in response to advancement of the first helical groove helically with respect to the first pin, the first pin is advanceable linearly with respect to the delivery tool so as to indicate a number of rotations of the tissue anchor into the tissue of the patient.

11. The apparatus according to claim 9, wherein:

the first cylindrical element is coupled to a proximal end of an elongate tube,

a distal end of the elongate tube is reversibly coupleable to the tissue anchor, and

during rotation of the first rotatable knob, the first cylindrical element rotates the elongate tube, and in turn, the elongate tube rotates the tissue anchor.

12. The apparatus according to claim 11, wherein:

the delivery tool further comprises a torque-delivering tool reversibly coupleable at a distal end thereof to the rotatable structure,

a proximal end of the torque-delivering tool is mechanically coupled to the second rotatable knob,

the torque-delivering tool is disposed at least in part within a lumen of the elongate tube,

during rotation of the first rotatable knob, the torque-delivering tool is not rotated within the elongate tube, and thus, the rotatable structure is not rotated.

13. The apparatus according to claim 12, wherein in response to rotation of the second rotatable knob, the torque-delivering tool is rotatable within the lumen of the elongate tube, and responsively to the rotation of the torque-delivering tool within the lumen of the elongate tool, the torque-delivering tool delivers torque to the rotatable structure in order to rotate the rotatable structure.

14. The apparatus according to claim 13, wherein the delivery tool comprises a second helical groove and a second pin, and wherein the second pin is mechanically coupled to the second rotatable knob and advanceable within the second helical groove.

15. The apparatus according to claim 14, wherein the delivery tool comprises a second cylindrical element that is shaped so as to define the second helical groove, and wherein the second rotatable knob is coupled to the second pin in a manner in which, during rotation of the second rotatable knob, the second pin is rotatable about the longitudinal axis of the delivery tool within the second helical groove.

16. The apparatus according to claim 15, wherein:

the delivery tool further comprises a rotator coupled to the proximal end of the torque-delivering tool,

the second rotatable knob is mechanically coupled to the rotator and configured to rotate the rotator in response to rotation of the second rotatable knob,

rotation of the rotator by the second rotatable knob rotates the torque-delivering tool, and

rotation of the torque-delivering tool rotates the rotatable structure.

17. The apparatus according to claim 15, wherein the second pin is coupled to a slidable indicator, and wherein, in response to rotation of the second pin within the second helical groove, the slidable indicator is advanceable linearly with respect to the delivery tool so as to indicate a number of rotations of the rotatable structure.

18. The apparatus according to claim 12, wherein the selected tissue-adjusting member comprises the one or more artificial chordae tendineae coupled at least in part to the rotatable structure, and wherein rotation of the rotatable structure adjusts a tension of the one or more chordae tendineae.

19. The apparatus according to claim 18, further comprising a housing surrounding the rotatable structure, and wherein the tissue anchor is coupled to the tissue-adjusting member via the housing.

20. The apparatus according to claim 18, wherein at least a portion of the one or more chordae tendineae is looped through a portion of the rotatable structure.

21. The apparatus according to claim 18, further comprising a tissue-coupling element, wherein each one of the one or more chordae tendineae has a free end, and wherein the free end is coupled to the tissue-coupling element.

22. The apparatus according to claim 21, wherein the delivery tool comprises a tissue-coupling element holder, and wherein the at least a portion of the tissue -coupling element is disposable within the tissue-coupling element holder during the screwing of the tissue anchor into the tissue of the patient.

23. The apparatus according to claim 18, wherein the rotatable structure comprises a spool, and wherein successive portions of the one or more chordae tendineae are configured to be wound around the spool responsively to rotation of the second knob in the first rotational direction, and to be unwound from around the spool responsively to rotation of the second knob in a second rotational direction that is opposite the first rotational direction.

24. The apparatus according to claim 23, wherein the delivery tool comprises a numerical indicator comprising a range of numbers configured to indicate a number of times the one or more chordae tendineae are wound around the rotatable structure.

25. The apparatus according to claim 24, wherein:

prior to the screwing of the tissue anchor, at least a portion of the one or more chordae tendineae is wound around a portion of the rotatable structure, and

the numerical indicator comprises a range of numbers indicating a number of times the one or more chordae tendineae are wound around the rotatable structure prior to the screwing of the tissue anchor.

26. The apparatus according to claim 12, wherein the delivery tool further comprises a rotatable-structure-manipulator, and wherein the rotatable-structure-manipulator is coupled to the distal end of the torque-delivering tool.

27. The apparatus according to claim 26, wherein a portion of the rotatable structure is shaped so as to define a first threaded portion, wherein a portion of the rotatable-structure-manipulator is shaped so as to define a second threaded portion, and wherein the rotatable-structure-manipulator is reversibly couplable to the rotatable structure when the second threaded portion is screwed with respect to the first threaded portion.

28. The apparatus according to claim 12, wherein the rotatable structure:

comprises a first end shaped to define a first opening,

comprises a second end having a lower surface shaped so as to define a second opening of the rotatable structure,

is shaped so as to define a channel extending from the first opening to the second opening, and

is shaped so as to define a first coupling at the lower surface of the second end thereof, and wherein the apparatus further comprises;

a mechanical element having a surface coupled to the lower surface of the rotatable structure, the mechanical element being shaped to provide;

a second coupling configured to engage the first coupling during a resting state of the mechanical element, in a manner that restricts rotation of the rotatable structure, and

a depressible portion coupled to the protrusion second coupling, the depressible portion being disposed in communication with the second opening of the lower surface, and configured to disengage the first and second couplings.

29. The apparatus according to claim 28, wherein the delivery tool elongate locking mechanism release comprises an elongate release rod configured to depress the depressible portion and to release the rotatable structure by disengaging the second coupling from the first coupling.

30. The apparatus according to claim 29, wherein the torque-delivering tool is shaped so as to define a torque-delivering tool lumen for slidable passage therethrough of the elongate release rod.

31. The apparatus according to claim 1, wherein the rotatable structure comprises a spool, and wherein the successive portions of the tissue-adjusting member are configured to be wound around the spool responsively to rotation of the spool in the first rotational direction, and to be unwound from around the spool responsively to rotation of the spool in a second rotational direction that is opposite the first rotational direction.

32. A method, comprising:

providing apparatus including;

a tissue-adjusting member configured to be coupled to tissue of a patient, the tissue-adjusting member including a tissue-adjusting member selected from the group consisting of;

one or more artificial chordae tendineae and at least a portion of an annuloplasty ring structure, the tissue-adjusting member including;

a rotatable structure that is configured to adjust a tension of the tissue-adjusting member, in a manner in which during rotation of the rotatable structure in a first rotational direction in order to apply tension to the tissue-adjusting member, successive portions of the tissue-adjusting member advance with respect to and contact the rotatable structure;

a locking mechanism coupled to the rotatable structure, the locking mechanism being configured to restrict rotation of the rotatable structure; and

a tissue anchor coupled to the tissue-adjusting member and configured to screw into the tissue of the patient; and

a tool reversibly coupleable to the rotatable structure, the tool including;

at least a first actuating element configured to rotate the rotatable structure while not facilitating rotation of the tissue anchor, and

an elongate locking mechanism release which slides through a lumen of the tool in order to facilitate (1) locking of the rotatable structure to restrict rotation of the rotatable structure, and (2) maintaining the rotatable structure in an unlocked state in order to facilitate rotation of the rotatable structure by the first actuating element and thereby facilitate the applying of tension to the tissue-adjusting member;

using the tool, rotating the rotatable structure by actuating the first actuating element of the tool, while not rotating the tissue anchor.

33. The method according to claim 32, wherein the rotatable structure includes a spool, and wherein rotating the rotatable structure comprises:

rotating the rotatable structure in the first rotational direction and responsively to the rotating in the first rotational direction, winding the successive portions of the tissue-adjusting member around the spool, and

rotating the rotatable structure in a second rotational direction that is opposite the first rotational direction, and responsively to the rotating in the second rotational direction, unwinding the successive portions from around the spool.

34. The method according to claim 32, further comprising, prior to the rotating, using the tool:

advancing toward the tissue of the patient the tissue-adjusting member coupled to the tissue anchor and the rotatable structure; and

implanting the tissue anchor in the tissue of the patient by screwing the tissue anchor into the tissue using the tool.

35. The method according to claim 34, wherein the tool includes a second actuating element, and wherein screwing the anchor into the tissue using the tool includes screwing the tissue anchor into the tissue by actuating the second actuating element of the tool while not rotating the rotatable structure.

36. The method according to claim 34, wherein the screwing of the tissue anchor and the rotating of the rotatable structure occur during a single advancing using the tool.

37. The method according to claim 34, wherein the screwing of the tissue anchor comprises screwing the tissue anchor along an axis of rotation, and wherein rotating the rotatable structure comprises rotating the rotating structure along the axis of rotation without moving the tool from the axis of rotation.

38. The method according to claim 34, wherein advancing toward the tissue of the patient comprises advancing at least a distal portion of the tool into a body cavity of the patient, and wherein the screwing of the tissue anchor and the rotating of the rotatable structure occur without extracting the distal portion of the tool from within the body cavity.

39. The method according to claim 34, wherein:

the selected tissue-adjusting member includes the one or more artificial chordae tendineae,

implanting the tissue anchor in the tissue comprises implanting the tissue anchor in a portion of tissue of a ventricle of a heart of the patient, and

the method further comprises coupling at least one free end of the one or more chordae tendineae to at least one native leaflet of a native atrioventricular valve.

40. The method according to claim 39, wherein rotating the rotatable structure comprises rotating the rotatable structure subsequently to the coupling to the at least one leaflet of the at least one free end of the one or more chordae tendineae.

41. The method according to claim 40, wherein rotating the rotatable structure comprises adjusting a tension of the one or more chordae tendineae.

42. The method according to claim 41, wherein advancing the tissue-adjusting member comprises advancing the tissue-adjusting member in a manner in which a portion of the one or more chordae tendineae is wound around a portion of the rotatable structure, and wherein adjusting the tension of the one or more chordae tendineae comprises unwinding the portion of the one or more chordae tendineae from around the rotatable structure subsequently to the coupling to the at least one leaflet of the at least one free end of the one or more chordae tendineae.

43. The method according to claim 42, wherein adjusting the tension of the one or more chordae tendineae comprises winding successive portions of the one or more chordae tendineae around the rotatable structure by rotating the rotatable structure in the first rotational direction.

44. The method according to claim 43, wherein adjusting the tension of the one or more chordae tendineae comprises unwinding the successive portions of the one or more chordae tendineae from around the rotatable structure by rotating the rotatable structure in a second rotational direction that is opposite the first rotational direction.