Over-wire implant contraction methods

• US 9,474,606 B2
• Filed: 09/16/2013
• Issued: 10/25/2016
• 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, Amir, Cabiri, Oz, Miller, Eran
• Primary Examiner(s): Iwamaye, Andrew
• Assistant Examiner(s): LOPEZ, LESLIE ANN
• Application Number:
  US14/027,934
• Publication Number:
  US 20140018914A1
• Time in Patent Office: 1,135 Days
• Field of Search: 623 236- 237, 623/2.38, 623/2.11, 623 239- 241, 623/23.65
• US Class Current: 1/1
• 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. A method comprising performing each of the following steps during a transcatheter procedure:

placing, into a body of a subject, an implant structure, which includes (a) exactly one continuous flexible sleeve, and (b) a contracting mechanism that is directly coupled to a flexible longitudinal member and includes a rotatable structure, such that the flexible longitudinal member extends outside of the body;

anchoring the implant structure to a tissue;

thereafter, guiding a tool along, over, and around the flexible longitudinal member to the rotatable structure by moving the tool;

thereafter, contacting and engaging the rotatable structure with the tool; and

thereafter, contracting the implant structure by rotating the rotatable structure using the tool, so as to contract the tissue.

2. The method according to claim 1, wherein the flexible longitudinal member includes an element selected from the group consisting of:

at least one wire, and a suture, and wherein guiding the tool along, over, and around the flexible longitudinal member comprises guiding the tool along, over, and around the selected element by moving the tool.

3. The method according to claim 2, further comprising decoupling the flexible longitudinal member from the contracting mechanism after rotating the rotatable structure.

4. The method according to claim 3, wherein a distal portion of the flexible 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 flexible longitudinal member is initially screwed, and wherein decoupling the flexible longitudinal member from the contracting mechanism comprises unscrewing the flexible longitudinal member from the threaded opening.

5. The method according to claim 3, wherein the flexible longitudinal member is removably coupled to the rotatable structure of the contracting mechanism, and wherein decoupling the flexible longitudinal member from the contracting mechanism comprises decoupling the flexible longitudinal member from the rotatable structure.

6. The method according to claim 3, wherein the tool includes a tube, wherein guiding the tool along, over, and around the selected element comprises passing the tube over and around the selected element, and wherein decoupling the flexible longitudinal member from the contracting mechanism comprises rotating the tube.

7. The method according to claim 6,

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 the rotatable structure with the tool 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.

8. The method according to claim 2, 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.

9. The method according to claim 2,

wherein the flexible sleeve has proximal and distal ends,

wherein the contracting mechanism is coupled to an external surface of the flexible sleeve within 1 cm of the distal end of the flexible sleeve,

wherein placing the implant structure into the body comprises deploying the distal end of the sleeve from a sheath and thereafter deploying the proximal end of the sleeve from the sheath, and

wherein guiding the tool along, over, and around the flexible longitudinal member comprises guiding the tool along, over, and around the selected element outside the flexible sleeve.

10. The method according to claim 2,

wherein the contracting mechanism includes a locking mechanism,

wherein the flexible longitudinal member is configured, when coupled to the contracting mechanism, to unlock the locking mechanism, thereby allowing the rotatable structure to rotate,

wherein contracting the implant structure by rotating the rotatable structure comprises rotating the rotatable structure when the locking mechanism is unlocked, and

wherein the method further comprises, after contracting the implant structure, locking the locking mechanism by decoupling the flexible longitudinal member from the contracting mechanism.

11. The method according to claim 1, wherein placing the implant structure into the body comprises placing an annuloplasty ring that includes the exactly one continuous flexible sleeve into an atrium of the body in a vicinity of an annulus of an atrioventricular valve.

12. The method according to claim 1, 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.

13. The method 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 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.

14. The method according to claim 1,

wherein the flexible sleeve has proximal and distal ends,

wherein the contracting mechanism is coupled to an external surface of the flexible sleeve within 1 cm of the distal end of the flexible sleeve,

wherein placing the implant structure into the body comprises deploying the distal end of the flexible sleeve from a sheath and thereafter deploying the proximal end of the flexible sleeve from the sheath, and

wherein guiding the tool along, over, and around the flexible longitudinal member comprises guiding the tool along, over, and around the flexible longitudinal member outside the flexible sleeve.

15. The method according to claim 1,

wherein the contracting mechanism includes a locking mechanism,

wherein the flexible longitudinal member is configured, when coupled to the contracting mechanism, to unlock the locking mechanism, thereby allowing the rotatable structure to rotate,

wherein contracting the implant structure by rotating the rotatable structure comprises rotating the rotatable structure when the locking mechanism is unlocked, and

wherein the method further comprises, after contracting the implant structure, locking the locking mechanism by decoupling the flexible longitudinal member from the contracting mechanism.

16. The method according to claim 1,

wherein the contracting mechanism includes a driving interface in a vicinity of a distal end of the implant structure,

wherein the tool is configured to engage the contracting mechanism via the driving interface, and

wherein placing the implant structure into the body comprises advancing the implant structure in a distal direction through a sheath.

17. The method according to claim 1, wherein placing comprises placing, into the body of the subject, the implant structure while the rotatable structure is directly coupled to the flexible longitudinal member.

18. A method comprising performing each of the following steps during a transcatheter procedure:

placing, into a body of a subject, an implant structure, which includes a contracting mechanism that (a) is coupled to a flexible longitudinal member and (b) includes a rotatable structure, such that the flexible longitudinal member extends outside of the body, wherein the flexible longitudinal member includes an element selected from the group consisting of;

at least one wire, and a suture, wherein a proximal end of the flexible longitudinal member passes at least partially through a rotation handle, which includes a first-tube rotation knob coupled to a first tube of a tool, a second-tube rotation knob coupled to a second tube of the tool, and a control knob, which (a) when in a first position, engages both the first-tube rotation knob and the second-tube rotation knob, 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 rotation handle, thereby rotationally fixing the control knob to the housing of the rotation handle;

anchoring the implant structure to a tissue;

thereafter, guiding the tool over the flexible longitudinal member to the rotatable structure by moving the tool, by passing the first tube over the flexible longitudinal member, wherein the first tube is positioned in the second tube;

thereafter, contacting and engaging the rotatable structure with the tool, by engaging the rotatable structure with the second tube;

thereafter, contracting the implant structure by rotating the rotatable structure using the tool, by rotating the first and second tubes by rotating the control knob when in the first position, so as to contact the tissue; and

after rotating the rotatable structure, decoupling the flexible longitudinal member from the contracting mechanism by moving the control knob into the second position, and subsequently rotating the first tube by rotating the first-tube rotation knob.

19. A method comprising performing each of the following steps during a transcatheter procedure:

placing, into a body of a subject, an implant structure, which includes (a) exactly one continuous flexible sleeve, and (b) a contracting mechanism directly coupled to a flexible longitudinal member, such that the flexible longitudinal member extends outside of the body;

anchoring the implant structure to a tissue;

thereafter, guiding a tool along, over, and around the flexible longitudinal member to the contracting mechanism by moving the tool;

thereafter, contacting and engaging the contracting mechanism with the tool; and

thereafter, using the tool, contracting the implant structure by actuating the contracting mechanism to pull on a flexible contracting member of the implant structure, which flexible contracting member is coupled to the contracting mechanism, so as to contact the tissue.

20. The method according to claim 19,

wherein the flexible sleeve has proximal and distal ends,

wherein the contracting mechanism is coupled to an external surface of the flexible sleeve within 1 cm of the distal end of the flexible sleeve,

wherein placing the implant structure into the body comprises deploying the distal end of the flexible sleeve from a sheath and thereafter deploying the proximal end of the flexible sleeve from the sheath, and

wherein guiding the tool along, over, and around the flexible longitudinal member comprises guiding the tool along, over, and around the flexible longitudinal member outside the flexible sleeve.

21. The method according to claim 19, wherein the flexible longitudinal member includes an element selected from the group consisting of:

at least one wire, and a suture, and wherein guiding the tool along, over, and around the flexible longitudinal member comprises guiding the tool along, over, and around the selected element by moving the tool.

22. The method according to claim 19, wherein placing the implant structure into the body comprises advancing the implant structure in a distal direction through a sheath while the flexible longitudinal member is coupled to the contracting mechanism in a vicinity of a distal end of the implant structure.

23. The method according to claim 19,

wherein the contracting mechanism includes a driving interface in a vicinity of a distal end of the implant structure,

wherein the tool is configured to engage the contracting mechanism via the driving interface, and

wherein placing the implant structure into the body comprises advancing the implant structure in a distal direction through a sheath.

24. A method comprising performing each of the following steps during a transcatheter procedure:

placing, into a body of a subject, an implant structure, which includes (a) exactly one continuous flexible sleeve, and (b) a contracting mechanism that is coupled to a flexible longitudinal member and includes a rotatable structure, such that the flexible longitudinal member extends outside of the body and terminates at the contracting mechanism;

anchoring the implant structure to a tissue;

thereafter, guiding a tool along, over, and around the flexible longitudinal member to the rotatable structure by moving the tool;

thereafter, contacting and engaging the rotatable structure with the tool; and

thereafter, contracting the implant structure by rotating the rotatable structure using the tool, so as to contract the tissue.

25. The method according to claim 24, wherein placing comprises placing, into the body of the subject, the implant structure while the flexible longitudinal member terminates at the rotatable structure.

26. The method according to claim 24, wherein the flexible longitudinal member includes an element selected from the group consisting of:

at least one wire, and a suture, and wherein guiding the tool along, over, and around the flexible longitudinal member comprises guiding the tool along, over, and around the selected element by moving the tool.

27. The method according to claim 26, further comprising decoupling the flexible longitudinal member from the contracting mechanism after rotating the rotatable structure.

28. The method according to claim 24, wherein placing the implant structure into the body comprises placing an annuloplasty ring that includes the exactly one continuous flexible sleeve into an atrium of the body in a vicinity of an annulus of an atrioventricular valve.

29. The method according to claim 24, 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.

30. A method comprising performing each of the following steps during a transcatheter procedure:

placing, into a body of a subject, an implant structure, which includes (a) exactly one continuous flexible sleeve, and (b) a contracting mechanism coupled to a flexible longitudinal member, such that the flexible longitudinal member extends outside of the body and terminates at the contracting mechanism;

anchoring the implant structure to a tissue;

thereafter, guiding a tool along, over, and around the flexible longitudinal member to the contracting mechanism by moving the tool;

thereafter, contacting and engaging the contracting mechanism with the tool; and

thereafter, using the tool, contracting the implant structure by actuating the contracting mechanism to pull on a flexible contracting member of the implant structure, which flexible contracting member is coupled to the contracting mechanisms, so as to contract the tissue.

31. The method according to claim 30, wherein the flexible longitudinal member includes an element selected from the group consisting of:

at least one wire, and a suture, and wherein guiding the tool along, over, and around the flexible longitudinal member comprises guiding the tool along, over, and around the selected element by moving the tool.