Active holder for annuloplasty ring delivery

• US 9,101,472 B2
• Filed: 02/07/2013
• Issued: 08/11/2015
• Est. Priority Date: 09/07/2007
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Keidar, Yaron, Adzich, W. Vaso, Rottenberg, Dan, Manash, Boaz, Nahshon, Alon
• Primary Examiner(s): ALEMAN, SARAH WEBB
• Application Number:
  US13/762,236
• Publication Number:
  US 20130150955A1
• Time in Patent Office: 915 Days
• Field of Search: 623/1.11, 623/1.12, 623/1.23, 623/2.11, 623/2.36, 623/2.37, 606/108, 606/144, 606/145
• US Class Current: 1/1
• 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 each having opposite ends attached to the template and a middle section passing through and holding the annuloplasty ring at the template peripheral edge; and

at least one severing tool partly incorporated into the template adapted to sever each suture between its ends without the need for a scalpel so as to release the annuloplasty ring from the template.

2. The holder of claim 1, further including a proximal handle, on a distal end of which is mounted the template, and wherein the handle includes a remote actuator that enables actuation of the severing tool.

3. The holder of claim 2, further including:

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

a handle detachment mechanism in the handle for detaching the sutures attaching the handle to the template, the handle detachment mechanism including a remote actuator in the handle.

4. The holder of claim 2, further including:

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

5. The holder of claim 2, 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.

6. The holder of claim 2, further including a pivot between the handle and the template so that the template can pivot to a variety of angles with respect to the handle.

7. The holder of claim 6, wherein the pivot enables approximately 180°

of rotation of the template with respect to the handle.

8. The holder of claim 6, further including a locking mechanism in the handle that permits a user to fix the angle of the template with respect to the handle.

9. The holder of claim 6, further including a pivoting actuator mounted on the handle that causes pivoting movement of the template.

10. The holder of claim 1, wherein the severing tool includes at least one hot wire that severs at least one of the sutures holding the annuloplasty ring to the template.

11. The holder of claim 10, wherein the hot wire is printed onto a circuit board that forms a part of the template.

12. The holder of claim 1, wherein the severing tool includes at least one blade that severs at least one of the sutures holding the annuloplasty ring to the template.

13. The holder of claim 1, wherein the severing tool includes at least one pull wire that severs at least one of the sutures holding the annuloplasty ring to the template.

14. The holder of claim 1, wherein the plurality of sutures are distributed around the template and extend generally radially inward to where a plurality of severing tools are located.

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

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

a handle attached to and extending proximally away from the template, the handle having a pivot on which the template pivots to a variety of angles with respect to the handle, the handle also having mounted therein a pivoting actuator that causes pivoting movement of the template;

at least one suture having opposite ends attached to the template and a middle section passing through and holding the annuloplasty ring at the template peripheral edge; and

a severing tool partly incorporated into the template adapted to sever the suture between its ends without the need for a scalpel so as to release the annuloplasty ring from the template.

16. The holder of claim 15, wherein the pivot enables approximately 180°

of rotation of the template with respect to the handle.

17. The holder of claim 15, further including a locking mechanism in the handle that permits a user to fix the angle of the template with respect to the handle.

18. The holder of claim 15, further including a pivoting mechanism between the pivoting actuator and the pivot selected from the group consisting of one of the following:

a gear train;

a pulley system; and

a push/pull rod linearly movable within the handle and connected to an eccentric projection of a pivot member on which the template mounts.

19. The holder of claim 15, wherein the pivoting actuator includes a rotation wheel that projects outward from a grip of the handle.

20. The holder of claim 15, wherein the handle also includes a remote actuator that enables actuation of the severing tool.

21. The holder of claim 15, wherein the severing tool includes a hot wire that severs the suture holding the annuloplasty ring to the template.

22. The holder of claim 15, wherein the severing tool includes a blade that severs the suture holding the annuloplasty ring to the template.

23. The holder of claim 15, wherein the severing tool includes a pull wire that severs the suture holding the annuloplasty ring to the template.

24. The holder of claim 15, wherein there are a plurality of sutures distributed around the template and extending generally radially inward to where a plurality of severing tools are located.