Deployment techniques for annuloplasty ring

• US 8,911,494 B2
• Filed: 01/19/2010
• Issued: 12/16/2014
• 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: Hammer, Tal, Zipory, Yuval, Weitzman, Yoseph, Gross, Amir, Cabiri, Oz, Ayvazian, Aram
• Primary Examiner(s): MCEVOY, THOMAS M
• Application Number:
  US12/689,693
• Publication Number:
  US 20100280605A1
• Time in Patent Office: 1,792 Days
• Field of Search: 606/232, 606301-320, 623/2.11, 623 236- 24, 811/761.5, 811/762, 814/51, 814/60, 814/61
• US Class Current: 623/2.11
• 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

An anchor driver is provided that includes a driver head having a flexible ring. An anchor is provided that includes a coupling head, which is shaped so as to define: (a) one or more mating elements that engage mechanical coupling elements of the driver head such that rotation of the mechanical coupling elements rotates the mating elements, which in turn rotate the coupling head, and (b) an outer coupling surface, sized to be inserted into and engage the flexible ring. The anchor also includes a tissue coupling element fixed to the coupling head. The rotation of the mechanical coupling elements causes the tissue coupling element of the anchor to screw itself into tissue, thereby causing separation of: (a) the outer coupling surface of the coupling head from the flexible ring, and (b) the mating elements of the coupling head from the corresponding mechanical coupling elements. Other embodiments are also described.

Claims

1. Apparatus for use with tissue of a subject, the apparatus comprising:

an anchor driver, which comprises a driver head, which is shaped so as to define one or more mechanical coupling elements, and which comprises a flexible ring; and

an anchor, which comprises;

a coupling head, which is shaped so as to define;

(a) one or more mating elements corresponding to the mechanical coupling elements, and configured to engage the mechanical coupling elements such that rotation of the mechanical coupling elements rotates the mating elements, which in turn rotate the coupling head, and (b) an outer coupling surface, sized and shaped to be inserted into and to be mechanically interlocked with the flexible ring; and

a tissue coupling element, which is fixed to the coupling head,

wherein the rotation of the mechanical coupling elements causes the tissue coupling element of the anchor to screw itself into the tissue, thereby causing separation of;

(a) the outer coupling surface of the coupling head from the flexible ring, and (b) the mating elements of the coupling head from the corresponding mechanical coupling elements, and

wherein the outer coupling surface of the coupling head is shaped so as to define a screw thread, such that rotation of the mechanical coupling elements causes the outer coupling surface to unscrew from the flexible ring.

2. The apparatus according to claim 1, wherein the driver head comprises:

an inner mating component, which is shaped so as to define the one or more mechanical coupling elements; and

an outer element, which at least partially surrounds the inner mating component and extends in a distal direction beyond a distal end of the inner mating component,

wherein the flexible ring is coupled to an inner surface of the outer element.

3. The apparatus according to claim 2, wherein the outer element is configured to rotate freely with respect to the inner mating component.

4. The apparatus according to claim 1, wherein the mechanical coupling elements of the driver head comprise protrusions, and wherein the mating elements of the coupling head comprise slots.

5. The apparatus according to claim 1, wherein the anchor driver further comprises a shaft, and wherein the driver head is coupled to a distal end of the shaft.

6. The apparatus according to claim 5, wherein the anchor driver comprises an inner mating component, which is shaped so as to define the one or more mechanical coupling elements, and wherein the inner mating component is coupled to the distal end of the shaft such that the inner mating component is rotationally fixed to the shaft.

7. The apparatus according to claim 1, further comprising an annuloplasty ring, which comprises a sleeve having a lumen, wherein the anchor driver is configured to be removably positioned within the lumen of the sleeve.

8. The apparatus according to claim 1, wherein the flexible ring comprises a material selected from the group consisting of:

rubber and silicone.

9. Apparatus comprising:

an annuloplasty ring, which comprises a sleeve having a lumen, the annuloplasty ring selected from the group consisting of;

a full annuloplasty ring and a partial annuloplasty ring;

an anchor deployment manipulator, which comprises;

(a) a deployment manipulator tube, which is removably positioned partially within the lumen of the sleeve, such that the deployment manipulator tube extends out of a proximal-most end of the sleeve; and

(b) an anchor driver, which is configured to be at least partially positioned within the deployment manipulator tube;

a pusher-tube unit, which comprises a pusher tube, which surrounds a portion of the deployment manipulator tube, such that (a) a distal-most end of the pusher tube is proximal to the proximal-most end of the sleeve, and (b) the pusher-tube unit removably contacts a proximal portion of the sleeve, such that distal movement of the pusher tube with respect to the deployment manipulator tube causes distal movement of the sleeve with respect to the deployment manipulator tube; and

at least one tissue anchor,

wherein the distal-most end of the pusher tube is removably coupled to the proximal-most end of the sleeve,

wherein the pusher-tube unit further comprises one or more coupling elements, which removably couple the pusher tube to the sleeve,

wherein the pusher-tube unit removably contacts the proximal portion of the sleeve by the one or more coupling elements removably contacting the proximal portion of the sleeve,

wherein the apparatus is configured such that;

when the deployment manipulator tube is positioned within the lumen of the sleeve, the deployment manipulator tube causes the coupling elements to engage the sleeve, thereby removably coupling the distal-most end of the pusher tube to the proximal-most end of the sleeve, and

when the deployment manipulator tube is withdrawn from the sleeve, the coupling elements disengage from the sleeve, thereby decoupling the distal-most end of the pusher tube from the proximal-most end of the sleeve,

wherein the coupling elements are configured to have a natural tendency to flex inwards toward a central longitudinal axis of the sleeve that passes through the proximal-most end of the sleeve, and

wherein the deployment manipulator tube, when positioned within the lumen of the sleeve, pushes the coupling elements outwards away from the central longitudinal axis, thereby causing the coupling elements to engage the sleeve.

10. The apparatus according to claim 9, further comprising an external control handle, which is coupled to a proximal portion of the deployment manipulator tube and to a proximal end of the pusher tube, and which is configured to controllably release the pusher tube in a distal direction as the sleeve is withdrawn from the deployment manipulator tube.

11. The apparatus according to claim 10, wherein the external control handle is configured to controllably release the pusher tube incrementally in the distal direction by one or more set distances.

12. The apparatus according to claim 9, wherein the anchor driver is configured, while at least partially positioned within the deployment manipulator tube, to deploy the at least one anchor through a wall of the sleeve.

13. The apparatus according to claim 9, wherein the pusher-tube unit removably contacts the proximal portion of the sleeve by the distal-most end of the pusher tube removably contacting the proximal-most end of the sleeve.

14. The apparatus according to claim 9, wherein the one or more coupling elements extend distally beyond the distal-most end of the pusher tube.

15. A method comprising:

advancing, into a body of a subject, (a) an anchor driver, which includes a driver head, which is shaped so as to define one or more mechanical coupling elements, and which comprises a flexible ring, and (b) an anchor, which includes (i) a coupling head, which is shaped so as to define;

(A) one or more mating elements corresponding to the mechanical coupling elements, and configured to engage the mechanical coupling elements such that rotation of the mechanical coupling elements rotates the mating elements, which in turn rotate the coupling head, and (B) an outer coupling surface, which is (1) sized and shaped to be inserted into and to be mechanically interlocked with the flexible ring, and (2) shaped so as to define a screw thread, and (ii) a tissue coupling element, which is fixed to the coupling head; and

rotating the mechanical coupling elements to cause (i) the tissue coupling element of the anchor to screw itself into tissue of the body, thereby causing separation of;

(a) the outer coupling surface of the coupling head from the flexible ring, and (b) the mating elements of the coupling head from the corresponding mechanical coupling elements, and (ii) the outer coupling surface to unscrew from the flexible ring.

16. The method according to claim 15, wherein the mechanical coupling elements of the driver head include protrusions, and wherein the mating elements of the coupling head include slots.

17. The method according to claim 15, wherein advancing the anchor driver comprises removably positioning the anchor driver within a lumen of a sleeve of an annuloplasty ring.

18. A method comprising:

removably positioning a deployment manipulator tube partially within a lumen of a sleeve of an annuloplasty ring, such that the deployment manipulator tube extends out of a proximal-most end of the sleeve, the annuloplasty ring selected from the group consisting of;

a full annuloplasty ring and a partial annuloplasty ring;

providing (a) an anchor driver, which is configured to be at least partially positioned within the deployment manipulator tube, and (b) at least one tissue anchor; and

placing a pusher tube of a pusher-tube unit over the deployment manipulator tube such that (a) a distal-most end of the pusher tube is proximal to the proximal-most end of the sleeve, and (b) the pusher-tube unit removably contacts a proximal portion of the sleeve, such that distal movement of the pusher tube with respect to the deployment manipulator tube causes distal movement of the sleeve with respect to the deployment manipulator tube, wherein the distal-most end of the pusher tube is removably coupled to the proximal-most end of the sleeve, wherein the pusher-tube unit further includes one or more coupling elements that removably couple the pusher tube to the sleeve, and wherein the pusher-tube unit removably contacts the proximal portion of the sleeve by the one or more coupling elements removably contacting the proximal portion of the sleeve,

wherein, when the deployment manipulator tube is positioned within the lumen of the sleeve, the deployment manipulator tube causes the coupling elements to engage the sleeve, thereby removably coupling the distal-most end of the pusher tube to the proximal-most end of the sleeve,

wherein, when the deployment manipulator tube is withdrawn from the sleeve, the coupling elements disengage from the sleeve, thereby decoupling the distal-most end of the pusher tube from the proximal-most end of the sleeve,

wherein the coupling elements are configured to have a natural tendency to flex inwards toward a central longitudinal axis of the sleeve that passes through the proximal-most end of the sleeve, and

wherein the deployment manipulator tube, when positioned within the lumen of the sleeve, pushes the coupling elements outwards away from the central longitudinal axis, thereby causing the coupling elements to engage the sleeve.

19. The method according to claim 18, wherein placing the pusher tube comprises placing the pusher tube over the deployment manipulator tube such that the pusher-tube unit removably contacts the proximal portion of the sleeve by the distal-most end of the pusher tube removably contacting the proximal-most end of the sleeve.

20. A method comprising:

advancing, into a body of a subject, (1) an annuloplasty ring selected from the group consisting of;

a full annuloplasty ring and a partial annuloplasty ring, the selected annuloplasty ring comprising a sleeve having a lumen, (2) a deployment manipulator tube of an anchor deployment manipulator, which deployment manipulator tube is removably positioned within the lumen of the sleeve such that the deployment manipulator tube extends out of a proximal-most end of the sleeve, and (3) a pusher tube of a pusher-tube unit, which pusher tube surrounds a portion of the deployment manipulator tube such that (a) a distal-most end of the pusher tube is proximal to the proximal-most end of the sleeve, and (b) the pusher-tube unit removably contacts a proximal portion of the sleeve, wherein the distal-most end of the pusher tube is removably coupled to the proximal-most end of the sleeve, wherein the pusher-tube unit further includes one or more coupling elements that removably couple the pusher tube to the sleeve, and wherein the pusher-tube unit removably contacts the proximal portion of the sleeve by the one or more coupling elements removably contacting the proximal portion of the sleeve;

removing at least part of the deployment manipulator tube from the lumen of the sleeve by pushing the pusher tube in a distal direction with respect to the deployment manipulator tube, so as to cause distal movement of the sleeve with respect to the deployment manipulator tube; and

driving at least one tissue anchor through a wall of the sleeve using an anchor driver of the anchor deployment manipulator, which anchor driver is at least partially positioned within the deployment manipulator tube,

wherein the presence of the anchor deployment manipulator within the sleeve maintains engagement of the coupling elements and the sleeve,

wherein the method further comprises decoupling the distal-most end of the pusher tube from the proximal-most end of the sleeve by withdrawing the deployment manipulator tube from the sleeve such that the coupling elements disengage from the sleeve,

wherein the coupling elements are configured to have a natural tendency to flex inwards toward a central longitudinal axis of the sleeve that passes through the proximal-most end of the sleeve, and

wherein withdrawing the deployment manipulator tube from the sleeve such that the coupling elements disengage from the sleeve comprises withdrawing the anchor deployment manipulator such that the coupling elements flex inwards toward the central longitudinal axis.

21. The method according to claim 20, wherein pushing the pusher tube comprises controllably pushing the pusher tube in the distal direction, using an external control handle to which is coupled a proximal portion of the deployment manipulator tube and a proximal-most end of the pusher tube.

22. The method according to claim 21, wherein controllably releasing comprises controllably releasing the pusher tube incrementally in the distal direction by one or more set distances.

23. The method according to claim 20, wherein the one or more coupling elements extend distally beyond the distal-most end of the pusher tube.

24. Apparatus for use with tissue of a subject, the apparatus comprising:

an anchor driver, which comprises a driver head, which is shaped so as to define one or more mechanical coupling elements, and which comprises a flexible ring, which comprises a material selected from the group consisting of;

rubber and silicone; and

an anchor, which comprises;

a coupling head, which is shaped so as to define;

(a) one or more mating elements corresponding to the mechanical coupling elements, and configured to engage the mechanical coupling elements such that rotation of the mechanical coupling elements rotates the mating elements, which in turn rotate the coupling head, and (b) an outer coupling surface, sized to be inserted into and engage the flexible ring; and

a tissue coupling element, which is fixed to the coupling head,

wherein the rotation of the mechanical coupling elements causes the tissue coupling element of the anchor to screw itself into the tissue, thereby causing separation of;

(a) the outer coupling surface of the coupling head from the flexible ring, and (b) the mating elements of the coupling head from the corresponding mechanical coupling elements, and

wherein the outer coupling surface of the coupling head is shaped so as to define a screw thread, such that rotation of the mechanical coupling elements causes the outer coupling surface to unscrew from the flexible ring.

25. A method comprising:

advancing, into a body of a subject, (a) an anchor driver, which includes a driver head, which is shaped so as to define one or more mechanical coupling elements, and which comprises a flexible ring, which comprises a material selected from the group consisting of;

rubber and silicone, and (b) an anchor, which includes (i) a coupling head, which is shaped so as to define;

(A) one or more mating elements corresponding to the mechanical coupling elements, and configured to engage the mechanical coupling elements such that rotation of the mechanical coupling elements rotates the mating elements, which in turn rotate the coupling head, and (B) an outer coupling surface, which is (1) sized to be inserted into and engage the flexible ring, and

(2) shaped so as to define a screw thread, and (ii) a tissue coupling element, which is fixed to the coupling head; and

rotating the mechanical coupling elements to cause (i) the tissue coupling element of the anchor to screw itself into tissue of the body, thereby causing separation of;

(a) the outer coupling surface of the coupling head from the flexible ring, and (b) the mating elements of the coupling head from the corresponding mechanical coupling elements, and (ii) the outer coupling surface to unscrew from the flexible ring.