Deployment techniques for annuloplasty ring and over-wire rotation tool

• US 9,636,224 B2
• Filed: 05/04/2010
• Issued: 05/02/2017
• 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: Zipory, Yuval, Cabiri, Oz, Hammer, Tal, Ayvazian, Aram
• Primary Examiner(s): Templeton, Christopher L
• Assistant Examiner(s): PAEZ, LUCAS M
• Application Number:
  US13/319,030
• Publication Number:
  US 20120078355A1
• Time in Patent Office: 2,555 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

Apparatus is provided for use with a subject, including an implant comprising a sleeve shaped so as to define a lumen therein, the sleeve having first and second portions. A contracting mechanism is coupled to a portion of an outer surface of the sleeve in a vicinity of the first portion of the sleeve. An elongated contracting member is coupled at a first end portion thereof to the contracting mechanism, and coupled at a second end portion thereof to the sleeve in a vicinity of the second portion of the sleeve. The contracting mechanism comprises a driving interface that is positioned so as to be accessible from the portion of the outer surface of the sleeve. The contracting mechanism is configured such that rotation of the driving interface contracts the implant by tightening the elongated contracting member. Other applications are also described.

Claims

1. Apparatus for use with a subject, comprising:

an implant comprising;

(a) an adjustable partial annuloplasty ring comprising a sleeve having proximal and distal ends, the sleeve defining a lumen;

(b) a contracting mechanism which comprises a housing, which housing is disposed at an outer surface of the ring, wherein the distal end of the sleeve closes the lumen, and the housing is disposed entirely outside the lumen of the sleeve; and

(c) an elongated contracting member, a first end portion of the elongated contracting member being coupled to the contracting mechanism and being disposed within the housing, and a second end portion of the elongated contracting member being coupled to the ring,

wherein the contracting mechanism comprises a driving interface that is positioned so as to be accessible from outside the ring, and

wherein the contracting mechanism is configured such that rotation of the driving interface contracts the implant by tightening the elongated contracting member.

2. The apparatus according to claim 1, further comprising:

at least one anchor; and

an anchor deployment manipulator, configured to be removably positioned within the lumen of the sleeve, and, while so positioned, to deploy the anchor from a distal end of the deployment manipulator through a wall of the sleeve, by penetrating the wall of the sleeve, into tissue of the subject.

3. The apparatus according to claim 2, wherein the at least one anchor comprises a plurality of anchors comprising between 5 and 20 anchors.

4. The apparatus according to claim 2, wherein:

the at least one anchor is shaped so as to define a coupling head and a tissue coupling element, which tissue coupling element is shaped so as to define a longitudinal axis, and is configured to penetrate cardiac tissue of the subject in a direction parallel to the longitudinal axis; and

the anchor deployment manipulator is configured to deploy the tissue coupling element in the direction parallel to the longitudinal axis of the tissue coupling element and parallel to a central longitudinal axis of the deployment manipulator through the distal end of the deployment manipulator.

5. The apparatus according to claim 4, wherein the deployment manipulator is configured to deploy the at least one anchor from the distal end of the deployment manipulator through the wall of the sleeve into the cardiac tissue, while the distal end of the deployment manipulator is positioned such that the central longitudinal axis through the distal end of the deployment manipulator forms an angle of between 45 and 90 degrees with the wall of the sleeve at a point at which the anchor penetrates the wall.

6. The apparatus according to claim 1, further comprising a longitudinal guide member reversibly coupled to the contracting mechanism, wherein the guide member is configured to guide a tool configured to engage the contracting mechanism.

7. The apparatus according to claim 6, wherein a portion of the guide member is looped through a portion of the contracting mechanism in a manner in which both ends of the guide member extend outside a body of the subject.

8. The apparatus according to claim 6, wherein a distal portion of the guide 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 guide member is screwed so as to removably couple the guide member to the contracting mechanism.

9. The apparatus according to claim 6, wherein the contracting mechanism comprises a locking mechanism, wherein the guide member is shaped so as to define a distal force applicator, which is configured to unlock the locking mechanism when the guide member is coupled to the contracting mechanism, thereby allowing actuation of the contracting mechanism.

10. The apparatus according to claim 6, wherein the guide member comprises a wire, and wherein the tool is configured to be advanced toward the contracting mechanism along the wire.

11. The apparatus according to claim 6, wherein the guide member comprises a tube, and wherein the tool is configured to be advanced toward the contracting mechanism through the tube.

12. The apparatus according to claim 6, wherein the contracting mechanism comprises a rotatable structure, and wherein the tool is configured to engage the rotatable structure, and to rotate the rotatable structure in response to a rotational force applied to the tool.

13. The apparatus according to claim 12, wherein the rotatable structure comprises a spool, wherein rotation of the spool winds a portion of the contracting member around the spool, and wherein the tool is configured to engage and rotate the spool.

14. The apparatus according to claim 12, wherein the tool comprises a screwing tool, which comprises a head and a shaft, and wherein the screwing tool is configured to be guided along the longitudinal guide member, such that the head is removably coupled to the driving interface of the contracting mechanism.

15. The apparatus according to claim 1, wherein the housing is disposed at a portion of the outer surface of the ring that is intermediate the proximal and distal ends of the sleeve.

16. The apparatus according to claim 1, wherein the contracting mechanism comprises a rotatable structure.

17. The apparatus according to claim 1, wherein the housing is disposed at a portion of the outer surface of the ring that is in a vicinity of the distal end of the sleeve.

18. Apparatus for use with a subject, comprising:

an implant comprising;

(a) an adjustable partial annuloplasty ring comprising a sleeve having proximal and distal ends, the sleeve defining a lumen;

(b) a contracting mechanism which comprises a housing, which housing is disposed at an outer surface of the ring, wherein the distal end of the sleeve closes the lumen, and the housing is disposed entirely outside the lumen of the sleeve; and

(c) an elongated contracting member, a first end portion of the elongated contracting member being coupled to the contracting mechanism and being disposed within the housing, and a second end portion of the elongated contracting member being coupled to the ring,

wherein the contracting mechanism comprises a driving interface that is positioned so as to be accessible from outside the ring, and

wherein the contracting mechanism is configured such that actuation of the driving interface contracts the implant by tightening the elongated contracting member.

19. The apparatus according to claim 18, wherein the contracting mechanism comprises a rotatable structure.

20. The apparatus according to claim 18, wherein the housing is disposed at a portion of the outer surface of the ring that is in a vicinity of the distal end of the sleeve.

21. A method, comprising:

providing;

an implant including;

(a) an adjustable partial annuloplasty ring including a sleeve having proximal and distal ends, the sleeve defining a lumen;

(b) a contracting mechanism which includes a housing, which housing is disposed at an outer surface of the ring, wherein the distal end of the sleeve closes the lumen, and the housing is disposed entirely outside the lumen of the sleeve; and

(c) an elongated contracting member, a first end portion of the elongated contracting member being coupled to the contracting mechanism and being disposed within the housing, and a second end portion of the elongated contracting member being coupled to the ring;

accessing an interface of the contracting mechanism from the outer surface of the ring; and

actuating the interface of the contracting mechanism and by the actuating, contracting the implant by tightening the elongated contracting member.

22. A method, comprising:

providing;

an implant including;

(a) an adjustable partial annuloplasty ring including a sleeve having proximal and distal ends, the sleeve defining a lumen;

(b) a contracting mechanism which includes a housing, which housing is disposed at an outer surface of the ring, wherein the distal end of the sleeve closes the lumen, and the housing is disposed entirely outside the lumen of the sleeve; and

(c) an elongated contracting member, a first end portion of the elongated contracting member being coupled to the contracting mechanism and being disposed within the housing, and a second end portion of the elongated contracting member being coupled to the ring;

accessing an interface of the contracting mechanism from the outer surface of the ring; and

rotating the interface of the contracting mechanism and by the rotating, contracting the implant by tightening the elongated contracting member.