Deployment techniques for annuloplasty ring and over-wire rotation tool

• US 10,548,729 B2
• Filed: 03/30/2017
• Issued: 02/04/2020
• 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: Zipory, Yuval, Cabiri, Oz, Gross, Yossi, Hammer, Tal, Gross, Amir, Maisano, Francesco, Miller, Eran, Weitzman, Yoseph, Ayvazian, Aram
• Primary Examiner(s): Ton, Martin T
• Application Number:
  US15/474,632
• Publication Number:
  US 20170258588A1
• Time in Patent Office: 1,041 Days
• Field of Search: 623 211, 623 236- 241
• CPC Class Codes: A61B 17/00234 for minimally invasive surgery A61B17/0218, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence
• 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 17/064 Surgical staples, i.e. penetrating the tissue
• CPC Class Codes: A61B 17/068 Surgical staplers , e.g. containing multiple staples or clampsstaplers containing only one staple A61B17/10; magazines or containers for staples A61B17/105; for performing anastomosis A61B17/115; staplers in general B25C5/00
• CPC Class Codes: A61B 17/072 for applying a row of staples in a single action , e.g. the staples being applied simultaneously
• 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 2017/0441 the shaft being a rigid coil or spiral
• CPC Class Codes: A61B 2017/0443 the shaft being resilient and having a coiled or helical shape in the released state
• CPC Class Codes: A61B 2017/0464 for soft tissue
• CPC Class Codes: A61B 2017/0496 for tensioning sutures
• CPC Class Codes: A61B 2017/0647 having one single leg, e.g. tacks
• CPC Class Codes: A61B 2017/0648 threaded, e.g. tacks with a screw thread
• CPC Class Codes: A61B 2017/0649 Coils or spirals
• CPC Class Codes: A61B 2017/12095 Threaded connection
• CPC Class Codes: A61B 2017/2923 Toothed members, e.g. rack and pinion
• CPC Class Codes: A61F 2/2409 Support rings therefor, e.g. for connecting valves to tissue annuloplasty rings A61F2/2442
• CPC Class Codes: A61F 2/2412 with soft flexible valve members, e.g. tissue valves shaped like natural valves check valves with flexible valve members in general F16K15/14
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/2445 : Annuloplasty rings in direct contact with the valve annulus
• CPC Class Codes: A61F 2/2451 : Inserts in the coronary sinus for correcting the valve shape
• CPC Class Codes: A61F 2/2457 : Chordae tendineae prostheses
• CPC Class Codes: A61F 2/2466 : Delivery devices therefor
• CPC Class Codes: A61F 2002/30537 : adjustable
• CPC Class Codes: A61F 2220/0016 : with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2250/0004 : adjustable

Abstract

An implant structure includes a contracting mechanism, including a rotatable structure for contracting the implant structure, and a locking mechanism. A rotation tool is configured to engage and rotate the rotatable structure. A longitudinal guide member is removably coupled to the contracting mechanism, configured to guide the rotation tool to the rotatable structure, and includes a distal force applicator. The rotation tool is axially moveable with respect to the guide member. The contracting mechanism is arranged such that the locking mechanism is (a) unlocked when the guide member is coupled to the contracting mechanism in a first state, thereby allowing the rotatable structure to rotate, and (b) locked when (i) the guide member is coupled to the contracting mechanism in a second state, thereby restricting the rotation of the rotatable structure, and (ii) the guide member is not coupled to the contracting mechanism, thereby restricting the rotation of the rotatable structure.

Claims

1. An apparatus comprising:

an implant structure, which comprises a contracting mechanism, which comprises (a) a rotatable structure, arranged such that rotation of the rotatable structure contracts the implant structure, and (b) a locking mechanism;

a rotation tool, which is configured to engage the rotatable structure, and to rotate the rotatable structure in response to a rotational force applied to the rotation tool; and

a longitudinal guide member, which is (a) removably coupled to the contracting mechanism, (b) configured to guide the rotation tool to the rotatable structure, and (c) comprises a distal force applicator,

wherein the rotation tool and the longitudinal guide member are arranged such that the rotation tool is axially moveable with respect to the longitudinal guide member, and

wherein the contracting mechanism is arranged such that;

the locking mechanism is unlocked when the longitudinal guide member is coupled to the contracting mechanism in a first state, thereby allowing the rotatable structure to rotate,

the locking mechanism is locked when the longitudinal guide member is coupled to the contracting mechanism in a second state, thereby restricting the rotation of the rotatable structure, and

the locking mechanism is locked when the longitudinal guide member is not coupled to the contracting mechanism, thereby restricting the rotation of the rotatable structure.

2. The apparatus according to claim 1, wherein the contracting mechanism is arranged such that:

when in the first state, the longitudinal guide member is coupled to the contracting mechanism at a first level of distal advancement with respect to the contracting mechanism, thereby allowing the rotatable structure to rotate, and

when in the second state, the longitudinal guide member is coupled to the contracting mechanism at a second level of distal advancement with respect to the contracting mechanism, thereby restricting the rotation of the rotatable structure, the second level of distal advancement being less than the first level of distal advancement.

3. The apparatus according to claim 2, wherein the rotation tool comprises one or more tubes that are configured to pass over the longitudinal guide member, such that the longitudinal guide member is radially within the one or more tubes.

4. The apparatus according to claim 2, wherein an upper surface of the rotatable structure is shaped so as to define a threaded opening, and wherein a distal portion of the longitudinal guide member is shaped so as to define a screw thread that is removably screwed into the threaded opening.

5. The apparatus according to claim 4, wherein, when the longitudinal guide member is coupled to the contracting mechanism at the second level of distal advancement, the distal portion of the longitudinal guide member is in a state of being partially unscrewed from the threaded opening.

6. The apparatus according to claim 4, wherein the distal force applicator extends distally beyond the screw thread, and is configured to unlock the locking mechanism when the longitudinal guide member is coupled to the contracting mechanism at the first level of distal advancement.

7. The apparatus according to claim 2,

wherein the locking mechanism is shaped to provide a protrusion and a depressible portion,

wherein a lower surface of the rotatable structure is shaped to define one or more recesses, and

wherein the contracting mechanism is arranged such that:

when the longitudinal guide member is coupled to the contracting mechanism at the second level of distal advancement or the longitudinal guide member is not coupled to the contracting mechanism, the protrusion is positioned with one of the recesses, thereby locking the locking mechanism, and

when the longitudinal guide member is coupled to the contracting mechanism at the first level of distal advancement, the force applicator pushes against the depressible portion, thereby freeing the protrusion from the recess and unlocking the locking mechanism.

8. The apparatus according to claim 2, wherein the rotatable structure comprises a spool.

9. The apparatus according to claim 8,

wherein the locking mechanism is shaped to provide a protrusion and a depressible portion,

wherein a lower surface of the spool is shaped to define one or more recesses, and

wherein the contracting mechanism is arranged such that:

when the longitudinal guide member is coupled to the contracting mechanism at the second level of distal advancement or the longitudinal guide member is not coupled to the contracting mechanism, the protrusion is positioned with one of the recesses, thereby locking the locking mechanism, and

when the longitudinal guide member is coupled to the contracting mechanism at the first level of distal advancement, the force applicator pushes against the depressible portion, thereby freeing the protrusion from the recess and unlocking the locking mechanism.

10. The apparatus according to claim 2, wherein the longitudinal guide member has a diameter of between 0.1 and 1 mm.

11. The apparatus according to claim 2, wherein the contracting mechanism comprises a housing that houses the rotatable structure, and wherein the contracting mechanism is arranged such that when unlocked, the locking mechanism allows the rotatable structure to rotate with respect to the housing.

12. The apparatus according to claim 2, wherein the implant structure further comprises a flexible elongated contracting member separate and distinct from the longitudinal guide member, and wherein the contracting mechanism is configured to contract the implant structure by pulling on the contracting member.

13. The apparatus according to claim 12,

wherein the rotatable structure comprises a spool,

wherein the contracting member has a first portion wound around the spool, and a second portion that extends at least along a portion of the implant structure,

wherein the spool is arranged such that the rotation of the spool contracts the implant structure by winding the contracting member around the spool, and

wherein the rotation tool is configured to increase a number of times the contracting member is wound around the spool by rotating the rotatable structure in response to the rotational force applied to the rotation tool.

14. The apparatus according to claim 1, wherein an upper surface of the rotatable structure is shaped so as to define a threaded opening, and wherein a distal portion of the longitudinal guide member is shaped so as to define a screw thread that is removably screwed into the threaded opening.

15. The apparatus according to claim 1,

wherein the locking mechanism is shaped to provide a protrusion and a depressible portion,

wherein a lower surface of the rotatable structure is shaped to define one or more recesses, and

wherein the contracting mechanism is arranged such that:

when the longitudinal guide member is coupled to the contracting mechanism in the second state or the longitudinal guide member is not coupled to the contracting mechanism, the protrusion is positioned with one of the recesses, thereby locking the locking mechanism, and

when the longitudinal guide member is coupled to the contracting mechanism in the first state, the force applicator pushes against the depressible portion, thereby freeing the protrusion from the recess and unlocking the locking mechanism.

16. The apparatus according to claim 1, wherein the implant structure comprises a sleeve.

17. The apparatus according to claim 1, wherein the implant structure comprises a plurality of tissue anchors.

18. An apparatus comprising:

an implant structure, which comprises (a) a flexible elongated contracting member and (b) a contracting mechanism, which (i) is configured to contract the implant structure by pulling on the contracting member, and (ii) comprises a locking mechanism;

a rotation tool, which is configured to engage the contracting mechanism, and to actuate the contracting mechanism to pull on the contracting member; and

a longitudinal guide member, which (a) is separate and distinct from the flexible elongated contracting member (b) is removably coupled to the contracting mechanism, (c) is configured to guide the rotation tool to the contracting mechanism, and (d) comprises a distal force applicator,

wherein the rotation tool and the longitudinal guide member are arranged such that the rotation tool is axially moveable with respect to the longitudinal guide member, and

wherein the contracting mechanism is arranged such that;

the locking mechanism is unlocked when the longitudinal guide member is coupled to the contracting mechanism in a first state, thereby allowing actuation of the contracting mechanism,

the locking mechanism is locked when the longitudinal guide member is coupled to the contracting mechanism in a second state, thereby locking the contracting mechanism, and

the locking mechanism is locked when the longitudinal guide member is not coupled to the contracting mechanism, thereby locking the contracting mechanism.

19. The apparatus according to claim 18, wherein the contracting mechanism is arranged such that:

when in the first state, the longitudinal guide member is coupled to the contracting mechanism at a first level of distal advancement with respect to the contracting mechanism, thereby allowing actuation of the contracting mechanism, and

when in the second state, the longitudinal guide member is coupled to the contracting mechanism at a second level of distal advancement with respect to the contracting mechanism, thereby locking the contracting mechanism, the second level of distal advancement being less than the first level of distal advancement.

20. The apparatus according to claim 19, wherein the rotation tool comprises one or more tubes that are configured to pass over the longitudinal guide member, such that the longitudinal guide member is radially within the one or more tubes.

21. The apparatus according to claim 19, wherein an upper surface of the contracting mechanism is shaped so as to define a threaded opening, and wherein a distal portion of the longitudinal guide member is shaped so as to define a screw thread that is removably screwed into the threaded opening.

22. The apparatus according to claim 21, wherein, when the longitudinal guide member is coupled to the contracting mechanism at the second level of distal advancement, the distal portion of the longitudinal guide member is in a state of being partially unscrewed from the threaded opening.

23. The apparatus according to claim 21, wherein the distal force applicator extends distally beyond the screw thread, and is configured to unlock the locking mechanism when the longitudinal guide member is coupled to the contracting mechanism at the first level of distal advancement.

24. The apparatus according to claim 19, wherein the contracting mechanism comprises a housing.

25. The apparatus according to claim 19,

wherein the contracting mechanism comprises a rotatable structure, arranged such that rotation of the rotatable structure contracts the implant structure by pulling on the contracting member, and

wherein the rotation tool is configured to engage the rotatable structure, and to rotate the rotatable structure in response to a rotational force applied to the rotation tool.

26. The apparatus according to claim 25, wherein the contracting mechanism comprises a housing that houses the rotatable structure.

27. The apparatus according to claim 26, wherein the contracting mechanism is arranged such that when unlocked, the locking mechanism allows the rotatable structure to rotate with respect to the housing.

28. The apparatus according to claim 25, wherein the rotatable structure comprises a spool.

29. The apparatus according to claim 28,

wherein the contracting member has a first portion wound around the spool, and a second portion that extends at least along a portion of the implant structure,

wherein the spool is arranged such that the rotation of the spool contracts the implant structure by winding the contracting member around the spool, and

wherein the rotation tool is configured to increase a number of times the contracting member is wound around the spool by rotating the rotatable structure in response to the rotational force applied to the rotation tool.

30. The apparatus according to claim 19, wherein the longitudinal guide member has a diameter of between 0.1 and 1 mm.

31. The apparatus according to claim 18, wherein an upper surface of the contracting mechanism is shaped so as to define a threaded opening, and wherein a distal portion of the longitudinal guide member is shaped so as to define a screw thread that is removably screwed into the threaded opening.

32. The apparatus according to claim 18, wherein the implant structure comprises a sleeve.

33. The apparatus according to claim 18, wherein the implant structure comprises a plurality of tissue anchors.

34. An apparatus comprising:

an implant structure, which comprises (a) a flexible elongated contracting member configured to contract the implant structure when the contracting member is tightened, and (b) a locking mechanism configured to restrict tightening of the contracting member;

a rotation tool, which is configured to engage the implant structure and to tighten the contracting member; and

a longitudinal guide member, which (a) is separate and distinct from the flexible elongated contracting member, (b) is removably coupled to the implant structure, (c) is configured to guide the rotation tool to the implant structure, and (d) comprises a distal force applicator,

wherein the rotation tool and the longitudinal guide member are arranged such that the rotation tool is axially moveable with respect to the longitudinal guide member, and

wherein the locking mechanism is arranged such that;

the locking mechanism is unlocked when the longitudinal guide member is coupled to the implant structure in a first state, thereby allowing the tightening of the contracting member,

the locking mechanism is locked when the longitudinal guide member is coupled to the implant structure in a second state, thereby restricting the tightening of the contracting member, and

the locking mechanism is locked when the longitudinal guide member is not coupled to the implant structure, thereby restricting the tightening of the contracting member.

35. The apparatus according to claim 34, wherein the contracting mechanism is arranged such that:

when in the first state, the longitudinal guide member is coupled to the implant structure at a first level of distal advancement with respect to the locking mechanism, thereby allowing tightening of the contracting member, and

when in the second state, the longitudinal guide member is coupled to the implant structure at a second level of distal advancement with respect to the locking mechanism, thereby restricting the tightening of the contracting member, the second level of distal advancement being less than the first level of distal advancement.

36. The apparatus according to claim 35, wherein the locking mechanism is configured to reversibly restrict the tightening of the contracting member.