Active holder for annuloplasty ring delivery

• US 8,377,117 B2
• Filed: 09/08/2008
• Issued: 02/19/2013
• Est. Priority Date: 09/07/2007
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Keidar, Yaron, Adzich, Vaso, Rottenberg, Dan, Manash, Boaz, Nahshon, Alon
• Primary Examiner(s): Sonnett, Kathleen
• Assistant Examiner(s): ALEMAN, SARAH WEBB
• Application Number:
  US12/206,604
• Publication Number:
  US 20090093877A1
• Time in Patent Office: 1,625 Days
• Field of Search: 623/2.11, 623 236- 237, 606/108, 606/144, 606/148
• US Class Current: 623/2.11
• CPC Class Codes: A61F 2/2427 Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: A61F 2/2448 D-shaped rings
• CPC Class Codes: A61F 2/2466 Delivery devices therefor

Abstract

An active annuloplasty ring holder having a template that can be folded or pivoted to the side allowing the template to align longitudinally with the handle and enter the patient'"'"'s chest through a small incision. The holder may include a mechanism to remotely detach sutures fastening the ring to the holder, thereby detaching the ring while avoiding the risk associated with introducing a scalpel into the operating field. A detachment mechanism may include a movable pin actuated by a pull wire that releases a plurality of holding sutures, or a hot wire, knives, or pull wire that severs the sutures. The holder may have a built-in light source for better visualization of the ring inside the heart. The holder may also have an optical means of visualizing the inside of the heart from the proximal end of the handle.

Claims

1. A holder for delivering an annuloplasty ring, comprising:

a template having a peripheral edge sized to receive an annuloplasty ring;

a plurality of sutures attaching the annuloplasty ring to the template;

a handle having a pivot on which the template pivots to a variety of angles with respect to the handle;

a ring detachment mechanism for detaching the sutures attaching the annuloplasty ring to the template, the ring detachment mechanism being remotely actuated from the handle and including a release pin movable in a bore in the template between an extended position around which the plurality of sutures loop to attach the annuloplasty ring to the template and a retracted position that frees the suture loops to detach the annuloplasty ring from the template; and

a pivoting mechanism in the handle for pivoting the template.

2. The holder of claim 1, wherein the pivoting mechanism includes a gear train.

3. The holder of claim 1, wherein the pivoting mechanism includes a pulley system.

4. The holder of claim 1, wherein the pivoting mechanism includes a push/pull rod linearly movable within the handle and connected to an eccentric projection of a pivot member on which the template mounts.

5. The holder of claim 1, further including a locking mechanism in the handle that permits a user to fix the angle of the template with respect to the handle.

6. The holder of claim 1, wherein the pivoting mechanism enables approximately 180°

of rotation of the template.

7. The holder of claim 1, wherein the ring detachment mechanism includes a pull wire.

8. The holder of claim 7, wherein the pull wire connects to and displaces the release pin to detach the annuloplasty ring from the template.

9. The holder of claim 1, further including:

a plurality of sutures attaching the handle to the template; and

a handle detachment mechanism for detaching the sutures attaching the handle to the template, the detachment mechanism being remotely actuated from the handle.

10. A holder for delivering an annuloplasty ring, comprising:

a template having a peripheral edge sized to receive an annuloplasty ring;

a plurality of sutures attaching the annuloplasty ring to the template;

a handle attached to the template; and

a ring detachment mechanism for detaching the sutures attaching the annuloplasty ring to the template, the ring detachment mechanism being remotely actuated from the handle and including a release pin movable in a bore in the template between an extended position around which the plurality of sutures loop to attach the annuloplasty ring to the template and a retracted position that frees the suture loops to detach the annuloplasty ring from the template.

11. The holder of claim 10, further including:

an optic lens mounted on the handle and directed toward the template, and a viewer mounted at a proximal end of the handle that permits a user to visualize the template through the lens.

12. The holder of claim 11, further including:

a source of illumination mounted on the handle and directed toward the template.

13. The holder of claim 12, wherein the source of illumination is mounted at the end of a malleable wire extending along the handle, and wherein a portion of the handle is malleable.

14. The holder of claim 10, further including a pull wire in the handle connected on a distal end to the release pin and on a proximal end to a ring release button in the handle, such that a user may displace the release pin from the extended position to the retracted position by pulling the ring release button.

15. The holder of claim 14, wherein the pull wire connects on its proximal end to a pulley mounted to translate with the ring release button, wherein the pulley is free to rotate unless the user pulls the ring release button.

16. The holder of claim 10, further including:

a plurality of sutures attaching the handle to the template; and

a handle detachment mechanism for detaching the sutures attaching the handle to the template, the detachment mechanism being remotely actuated from the handle.

17. The holder of claim 10, further including:

a pull wire in the handle connected on a distal end to the release pin and on a proximal end to a ring release button in the handle, such that a user may displace the release pin from the extended position to the retracted position by actuating the ring release button; and

a handle detachment mechanism for detaching the handle from the template,

wherein the pull wire mounts in the handle in a manner that prevents application of tension sufficient to displace the release pin from the extended position to the retracted position when the handle detaches and is displaced away from the template unless the user actuates the ring release button.

18. The holder of claim 10, further including a pivoting mechanism in the handle for pivoting the template.

19. The holder of claim 18, further including a locking mechanism in the handle that permits a user to fix the angle of the template with respect to the handle.

20. The holder of claim 10, wherein each of the plurality of sutures is anchored at its free ends to the template and a mid-portion of each suture passes in two parallel threads outward through holes in the template and through the annuloplasty ring, and then inward through holes in the template to loop around the release pin.

21. The holder of claim 20, wherein the plurality of sutures are distributed around the template and the release pin is located generally centrally in the template.

22. The holder of claim 20, wherein the release pin projects beyond a distal face of the template in its extended position and the plurality of sutures each passes inward across the distal face of the template to loop around the release pin in its extended position.

23. The holder of claim 10, further including a removable release pin cover that prevents inadvertent deployment of the ring release pin from its extended position to its retracted position.

24. A holder for delivering an annuloplasty ring, comprising:

a template having a peripheral edge sized to receive an annuloplasty ring;

a plurality of sutures attaching the annuloplasty ring to the template;

a handle attached to the template; and

a ring detachment mechanism for detaching the sutures attaching the annuloplasty ring to the template, the ring detachment mechanism being remotely actuated from the handle, wherein the ring detachment mechanism includes a pull wire, and wherein the plurality of sutures attaching the annuloplasty ring to the template loop around a release pin movable in a bore in the template, and the pull wire connects to and displaces the release pin to detach the annuloplasty ring from the template.

25. The holder of claim 24, further including:

a plurality of sutures attaching the handle to the template; and

a handle detachment mechanism for detaching the sutures attaching the handle to the template, the detachment mechanism being remotely actuated from the handle.

26. The holder of claim 25, wherein the pull wire connects on a proximal end to a ring release button in the handle, such that a user may displace the release pin from the extended position to the retracted position by actuating the ring release button, wherein the pull wire mounts in the handle in a manner that prevents application of tension sufficient to displace the release pin from the extended position to the retracted position when the handle detaches and is displaced away from the template unless the user actuates the ring release button.

27. The holder of claim 26, wherein the pull wire connects on its proximal end to a pulley mounted to translate with the ring release button, wherein the pulley is free to rotate unless the user actuates the ring release button.

28. The holder of claim 24, further including a pivoting mechanism in the handle for pivoting the template.

29. The holder of claim 28, further including a locking mechanism in the handle that permits a user to fix the angle of the template with respect to the handle.

30. The holder of claim 24, wherein each of the plurality of sutures is anchored at its free ends to the template and a mid-portion of each suture passes in two parallel threads outward through holes in the template and through the annuloplasty ring, and then inward through holes in the template to loop around the release pin.

31. The holder of claim 30, wherein the plurality of sutures are distributed around the template and the release pin is located generally centrally in the template.

32. The holder of claim 30, wherein the release pin projects beyond a distal face of the template in its extended position and the plurality of sutures each passes inward across the distal face of the template to loop around the release pin in its extended position.

33. The holder of claim 24, further including a removable release pin cover that prevents inadvertent deployment of the ring release pin from its extended position to its retracted position.