Over-wire rotation tool

• US 8,545,553 B2
• Filed: 01/19/2010
• Issued: 10/01/2013
• 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: Zipory, Yuval, Hammer, Tal, Gross, Yossi, Gross, Amir, Cabiri, Oz, Maisano, Francesco, Miller, Eran
• Primary Examiner(s): Iwamaye, Andrew
• Assistant Examiner(s): COBURN, LESLIE ANN
• Application Number:
  US12/689,635
• Publication Number:
  US 20100280604A1
• Time in Patent Office: 1,351 Days
• Field of Search: 623/2.11, 623 236- 237, 623 238- 241, 623/23.65, 604/179
• US Class Current: 623/2.37
• 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
• 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 2017/0443 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

Apparatus is provided that includes an implant structure, which includes a contracting mechanism, which includes a rotatable structure, arranged such that rotation of the rotatable structure contracts the implant structure. A longitudinal member is coupled to the contracting mechanism. A tool for rotating the rotatable structure is configured to be guided along the longitudinal member, to engage the rotatable structure, and to rotate the rotatable structure in response to a rotational force applied to the tool. Other embodiments are also described.

Claims

1. Apparatus comprising:

an implant structure, which comprises a contracting mechanism, which comprises;

a rotatable structure, which comprises a spool; and

a flexible contracting member having 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 rotation of the spool contracts the implant structure by winding the contracting member around the spool;

a longitudinal member, which is coupled to the contracting mechanism; and

a tool for rotating the rotatable structure, the tool configured;

to be guided along the longitudinal member toward the contracting mechanism while the longitudinal member is coupled to the contracting mechanism,

after being guided along the longitudinal member, to contact and engage the rotatable structure while the longitudinal member is coupled to the contracting mechanism, and

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

2. The apparatus according to claim 1, wherein the longitudinal member comprises at least one wire, and wherein the tool is configured to be guided over the wire.

3. The apparatus according to claim 1, wherein the implant structure comprises an annuloplasty ring.

4. The apparatus according to claim 1, wherein the implant structure comprises at least one repair chord, which is configured to pull two portions of heart tissue toward each other upon contraction of the implant structure.

5. The apparatus according to claim 1, wherein the implant structure comprises one or more tissue anchors.

6. The apparatus according to claim 1, wherein the contracting mechanism comprises a housing that houses the spool, and wherein the tool is configured to engage and rotate the spool with respect to the housing.

7. The apparatus according to claim 6, wherein the tool comprises a tube, which, when passed over the longitudinal member and engaged with the housing, holds the housing rotationally stationary with respect to the tube.

8. The apparatus according to claim 1, wherein the longitudinal member is removably coupled to the contracting mechanism.

9. The apparatus according to claim 8, wherein a distal portion of the longitudinal member is shaped so as to define a screw thread, and wherein the contracting mechanism is shaped so as to define a threaded opening, into which the distal portion of the longitudinal member is screwed so as to removably couple the longitudinal member to the contracting mechanism.

10. The apparatus according to claim 8, wherein the contracting mechanism comprises a housing that houses the spool, wherein the tool is configured to engage and rotate the spool with respect to the housing, and wherein the contracting mechanism comprises a locking mechanism, and wherein the longitudinal member is shaped so as to define a distal force applicator, which is configured to unlock the locking mechanism when the longitudinal member is coupled to the contracting mechanism, thereby allowing the spool to rotate with respect to the housing.

11. The apparatus according to claim 8, wherein the longitudinal member is removably coupled to the rotatable structure of the contracting mechanism.

12. The apparatus according to claim 8, wherein the tool comprises a tube, which is configured to pass over the longitudinal member, and which is configured such that rotation of the tube decouples the longitudinal member from the contracting mechanism.

13. The apparatus according to claim 12, wherein the tube is a first tube, wherein the tool further comprises a second tube, wherein the first tube is positioned within the second tube, and wherein the second tube is configured to engage the rotatable structure, such that rotation of the second tube rotates the rotatable structure.

14. The apparatus according to claim 13,

wherein the tool further comprises a third tube,

wherein the first and second tubes are positioned within the third tube,

wherein the contracting mechanism comprises a housing that houses the spool,

wherein the implant structure is coupled to the spool, and arranged such that rotation of the spool winds a portion of the implant structure around the spool, and wherein the second tube is configured to engage and rotate the spool with respect to the housing, and

wherein the third tube, when engaged with the housing, holds the housing rotationally stationary with respect to the third tube.

15. The apparatus according to claim 13, further comprising a rotation handle, through which a proximal end of the longitudinal member at least partially passes, and which comprises:

a first-tube rotation knob, which is coupled to the first tube, such that rotation of the first-tube rotation knob rotates the first tube;

a second-tube rotation knob, which is coupled to the second tube, such that rotation of the second-tube rotation knob rotates the second tube; and

a control knob, which;

when in a first position, engages both first-tube and second-tube rotation knobs, and

when in a second position, engages the second-tube rotation knob but not the first-tube rotation knob.

16. The apparatus according to claim 15, wherein the rotation handle comprises a handle housing, and wherein the control knob, when in the second position, engages the handle housing, thereby rotationally fixing the control knob to the handle housing.

17. The apparatus according to claim 1, wherein a portion of the implant structure is shaped so as to define a rack, wherein a portion of the rotatable structure is shaped so as to define a pinion that mates with the rack, and wherein the implant structure is configured such that rotation of the rotatable structure causes the portion of the implant structure to move with respect to the rotatable structure.

18. The apparatus according to claim 1, wherein the longitudinal member comprises a tube, and wherein the tool is configured to be guided through the tube.

19. The apparatus according to claim 1, wherein the rotatable structure has an axis of rotation that is perpendicular to a central longitudinal axis of the implant structure in a vicinity of the rotatable structure.

20. The apparatus according to claim 1, wherein the rotatable structure has an axis of rotation that is perpendicular to a central longitudinal axis of the implant structure in a vicinity of the rotatable structure when the tool is engaged to the rotatable structure.

21. The apparatus according to claim 1,

wherein the implant structure further comprises a flexible sleeve,

wherein the contracting mechanism comprises a housing that houses the rotatable structure, and

wherein the housing is directly coupled to an external surface of the sleeve.

22. The apparatus according to claim 21, wherein the external surface of the sleeve is an external, lateral surface of the sleeve, and wherein the housing is directly coupled to the external, lateral surface of the sleeve.

23. Apparatus comprising:

an implant structure comprising (a) a flexible sleeve and (b) a contracting mechanism that comprises (i) a rotatable structure and (ii) a housing that houses the rotatable structure and is directly coupled to an external, lateral surface of the sleeve;

a longitudinal member, which is coupled to the contracting mechanism; and

a tool for rotating the rotatable structure, the tool configured;

to be guided along the longitudinal member toward the contracting mechanism while the longitudinal member is coupled to the contracting mechanism,

after being guided along the longitudinal member, to contact and engage the rotatable structure while the longitudinal member is coupled to the contracting mechanism, and

to rotate the rotatable structure in response to a rotational force applied to the tool.

24. The apparatus according to claim 23, wherein the implant structure comprises a flexible contracting member that is coupled to the rotatable structure, and is arranged such that rotation of the rotatable structure tightens the flexible contracting member, thereby contracting the implant structure.

25. The apparatus according to claim 23,

wherein the rotatable structure comprises a spool,

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

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

26. The apparatus according to claim 23,

wherein the longitudinal member is removably coupled to the contracting mechanism,

wherein a distal portion of the longitudinal member is shaped so as to define a screw thread, and

wherein the contracting mechanism is shaped so as to define a threaded opening, into which the distal portion of the longitudinal member is screwed so as to removably couple the longitudinal member to the contracting mechanism.

27. The apparatus according to claim 23, wherein the implant structure comprises a flexible contracting member that is coupled to the rotatable structure, and is arranged such that rotation of the rotatable structure tightens the flexible contracting member, thereby contracting the implant structure.

28. The apparatus according to claim 23, wherein the tool comprises a tube, which, when passed over the longitudinal member and engaged with the housing, holds the housing rotationally stationary with respect to the tube.

29. The apparatus according to claim 23, wherein the rotatable structure has an axis of rotation that is perpendicular to a central longitudinal axis of the implant structure in a vicinity of the rotatable structure.

30. The apparatus according to claim 23, wherein the rotatable structure has an axis of rotation that is perpendicular to a central longitudinal axis of the implant structure in a vicinity of the rotatable structure when the tool is engaged to the rotatable structure.

31. A method comprising:

providing (a) an implant structure, which includes a contracting mechanism that includes (i) a rotatable structure, which comprises a spool, and (ii) a flexible contracting member having a first portion wound around the spool, and a second portion that extends at least along a portion of the implant structure, and (b) a longitudinal member coupled to the contracting mechanism;

placing, into a body of a subject, the implant structure such that the longitudinal member extends outside of the body;

guiding a tool along the longitudinal member to the rotatable structure while the longitudinal member is coupled to the contracting mechanism;

after guiding the tool along the longitudinal member, contacting and engaging the rotatable structure with the tool while the longitudinal member is coupled to the contracting mechanism; and

contracting the implant structure by increasing a number of times the contracting member is wound around the spool by winding the contracting member around the spool by rotating the rotatable structure by applying a rotational force to the tool.

32. The method according to claim 31, wherein placing the implant structure comprises placing an annuloplasty ring into an atrium of the body in a vicinity of an annulus of an atrioventricular valve.

33. The method according to claim 31, wherein placing the implant structure comprises placing at least one repair chord into a ventricle of the body such that, upon contracting of the implant structure, the repair chord pulls two portions of heart tissue toward each other.

34. The method according to claim 31, further comprising decoupling the longitudinal member from the contracting mechanism after rotating the rotatable structure.

35. The method according to claim 34, wherein a distal portion of the longitudinal member is shaped so as to define a screw thread, wherein the contracting mechanism is shaped so as to define a threaded opening, into which the distal portion of the longitudinal member is initially screwed, and wherein decoupling comprises unscrewing the longitudinal member from the threaded opening.

36. The method according to claim 34, wherein the longitudinal member is removably coupled to the rotatable structure of the contracting mechanism, and wherein decoupling comprises decoupling the longitudinal member from the rotatable structure.

37. The method according to claim 34, wherein the contracting mechanism includes a housing that houses the spool, wherein winding comprises rotating the spool with respect to the housing, wherein the contracting mechanism includes a locking mechanism, and wherein the longitudinal member is shaped so as to define a distal force applicator, which is configured to unlock the locking mechanism when the longitudinal member is coupled to the contracting mechanism, thereby allowing the spool to rotate with respect to the housing.

38. The method according to claim 34, wherein the tool includes a tube, wherein guiding the tool over the longitudinal member comprises passing the tube over the longitudinal member, and wherein decoupling the longitudinal member from the contracting mechanism comprises rotating the tube.

39. The method according to claim 38,

wherein the tube is a first tube,

wherein rotating the tube comprises rotating the first tube,

wherein the tool further includes a second tube,

wherein the first tube is positioned within the second tube,

wherein engaging comprises engaging the rotatable structure with the second tube, and

wherein contracting the implant structure comprises rotating the rotatable structure by rotating the second tube.

40. The method according to claim 39, further comprising passing a proximal end of the longitudinal member at least partially through a rotation handle, which includes a first-tube rotation knob coupled to the first tube, a second tube-rotation knob coupled to the second tube, and a control knob, which (a) when in a first position, engages both the first-tube and second-tube rotation knobs, and (b) when in a second position, engages the second-tube rotation knob but not the first-tube rotation knob, and engages a housing of the handle, thereby rotationally fixing the control knob to the handle housing,

wherein contracting the implant structure comprises rotating the first and second tubes by rotating the control knob when in the first position, and

wherein decoupling the longitudinal member from the contracting mechanism comprises moving the control knob into the second position, and subsequently rotating the first tube by rotating the first-tube rotation knob.

41. The method according to claim 39,

wherein the tool further includes a third tube,

wherein the first and second tubes are positioned within the third tube,

wherein the contracting mechanism includes a housing that houses the spool,

wherein the implant structure is coupled to the spool, and

wherein contracting the implant comprises:

rotating a portion of the implant structure around the spool by rotating the spool with respect to the housing by rotating the second tube;

engaging the housing with the third tube; and

holding the housing rotationally stationary by holding the third tube rotationally stationary.

42. The method according to claim 31, wherein the longitudinal member includes at least one wire, and wherein guiding the tool comprises guiding the tool over the wire.

43. The method according to claim 31, wherein the contracting mechanism includes a housing that houses the spool, and wherein winding comprises rotating the spool with respect to the housing.

44. The method according to claim 43, wherein the tool includes a tube, and wherein guiding the tool over the longitudinal member comprises passing the tube over the longitudinal member and engaging the housing with the tube such that the housing is held rotationally stationary when the tube is held rotationally stationary.

45. The method according to claim 31, wherein a portion of the implant structure is shaped so as to define a rack, wherein a portion of the rotatable structure is shaped so as to define a pinion that mates with the rack, and wherein contracting the implant structure comprises moving the portion of the implant structure with respect to the rotatable structure by rotating the rotatable structure using the tool.

46. The method according to claim 31, wherein the longitudinal includes at least one tube, and wherein guiding the tool comprises guiding the tool through the tube.

47. A method comprising:

providing (a) an implant structure that includes (i) a flexible sleeve and (ii) a contracting mechanism that includes (x) a rotatable structure and (y) a housing that houses the rotatable structure and is directly coupled to an external, lateral surface of the sleeve, and (b) a longitudinal member coupled to the contracting mechanism;

placing, into a body of a subject, the implant structure such that the longitudinal member extends outside of the body;

guiding a tool along the longitudinal member to the contracting mechanism while the longitudinal member is coupled to the contracting mechanism;

after guiding the tool along the longitudinal member, contacting and engaging the rotatable structure with the tool while the longitudinal member is coupled to the contracting mechanism; and

rotating the rotatable structure by applying a rotational force to the tool.

48. The method according to claim 47, wherein the implant structure includes a flexible contracting member that is coupled to the rotatable structure, and wherein contracting the implant structure comprises tightening the flexible contracting member by rotating the rotatable structure using the tool.

49. The method according to claim 47,

wherein the rotatable structure includes a spool,

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

wherein engaging comprises engaging the spool with the tool, and

wherein contracting the implant structure comprises winding the contracting member around the spool by rotating the spool using the tool.