Annuloplasty ring delivery system

• US 6,802,860 B2
• Filed: 04/08/2003
• Issued: 10/12/2004
• Est. Priority Date: 07/31/1989
• Status: Expired due to Fees

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Nguyen, Than, Cosgrove, Delos M.
• Primary Examiner(s): Willse, David H.
• Application Number:
  US10/410,458
• Publication Number:
  US 20030195619A1
• Time in Patent Office: 553 Days
• Field of Search: 623/2.11, 623/2.36, 623/2.37
• US Class Current: 623/2.11
• CPC Class Codes: A61B 17/0482 Needle or suture guides guides for drills, pins or wire A61B17/17; for puncturing needles A61B17/3403
• CPC Class Codes: A61B 50/20 Holders specially adapted for surgical or diagnostic appliances or instruments drapes with means to hold surgical instruments A61B46/23; for catheters A61M25/02
• CPC Class Codes: A61B 90/00 Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges protective face masks A41D13/11; surgeon's or patient's gowns or dresses A41D13/12; devices for carrying-off, for treatment of, or for carrying-over, body liquids A61M1/00
• CPC Class Codes: A61F 2/2445 Annuloplasty rings in direct contact with the valve annulus
• CPC Class Codes: A61F 2/2448 D-shaped rings
• CPC Class Codes: A61F 2/2466 Delivery devices therefor
• CPC Class Codes: Y10S 623/90 Stent for heart valve
• CPC Class Codes: Y10S 623/904 Heart

Abstract

An assembly for holding a substantially flexible suture guide of predetermined length in a substantially taut position used to achieve a suture line having a dimension equal to the length of the suture guide, such as the circumference about a heart valve annulus. The assembly includes a rigid suture guide holder having a surface against which the length of suture guide is releasably positioned. The guide holder can have a shape or geometry, such as a circumference or circumferential segment, equivalent to the shape or geometry of the intended suture line. The shape of the guide holder can therefore be selected to hold the suture guide in the shape most advantageous to placing the desired suture line. The assembly further includes a mechanism for releasably binding the suture guide to the surface of the holder and a detachable handle extendibly attached to the holder by means of a lanyard so that the handle can be detached to afford an unobstructed view of the surgical site, but cannot be removed from the surgical site until the holder has also been removed.

Claims

1. An annuloplasty ring delivery system, comprising:

an annuloplasty ring; and

a rigid template defining at least a partial circumferential edge about which the annuloplasty ring is fitted, the template having one or more cutting guides formed therein adjacent the partial circumferential edge, the annuloplasty ring being attached about the circumferential edge by one or more sutures, each suture being secured to the rigid template, threaded through the annuloplasty ring and passed over one of the cutting guides, wherein the template can be de-coupled from the annuloplasty ring by severing each suture at the respective cutting guide.

2. The system of claim 1, further comprising:

a handle coupled to the template;

a tethered connection between the handle and template.

3. The system of claim 2, wherein the handle comprises a spool having a tether wound therearound, one end of the tether being attached to the template.

4. The system of claim 3, wherein the handle removably attaches to the template with severable sutures.

5.The system of claim 1, wherein the partial circumferential edge is a circumferential groove defined by the template.

5. The system of claim 1, wherein the partial circumferential edge is a circumferential trough defined by the template.

6. The system of claim 1, wherein the partial circumferential edge is a circumferential depression defined by the template.

7. The system of claim 1, wherein the partial circumferential edge is a circumferential channel defined by the template.

8. The system of claim 1, wherein the partial circumferential edge is a circumferential flat surface defined by the template.

9. The system of claim 1, wherein the template has a visibility window defined within the circumferential edge for viewing a target annulus through the window.

13. The system of claim 1, wherein the rigid template is generally formed in a plane, and each cutting guide extends and has a groove formed therein such that the corresponding suture spans the groove and a cutting tool can be inserted into each groove to sever the sutures.

14. The system of claim 1, further including apertures formed in the rigid template and disposed so that the sutures extend directly therethrough into the annuloplasty ring and an outer periphery of the annuloplasty ring is un-obstructed for an implant procedure.

10. The system of claim 10, wherein the rigid template comprises a planar member extending generally in a plane defined by the circumferential edge, and wherein the visibility window comprises an opening formed in the planar member.

11. The system of claim 11, wherein there are a plurality of visibility windows formed in the planar member between spokes extending from the circumferential edge to a central location.

12. The system of claim 12, further including a hub joining the spokes at the central location, wherein a handle can be attached to the hub for manipulating the template.

15. A system of implanting an annuloplasty ring, comprising:

an annuloplasty ring; and

a rigid body having an outwardly facing surface against which the annuloplasty ring is positioned and held in a fixed shape using at least one suture that is fixed with respect to the rigid body, the suture passing through the ring, such that an outer periphery of the ring defines an outermost surface of a ring/rigid body assembly, wherein the rigid body can be detached from the annuloplasty ring by severing the suture and removing the rigid body and severed suture from the secured ring.

16. The system of claim 16, wherein the outwardly facing surface is a circumferential groove defined by the rigid body.

17. The system of claim 16, wherein the outwardly facing surface is a circumferential trough defined by the rigid body.

18. The system of claim 16, wherein the outwardly facing surface is a circumferential depression defined by the rigid body.

19. The system of claim 16, wherein outwardly facing surface is a circumferential channel defined by the rigid body.

20. The system of claim 16, wherein the outwardly facing surface is a circumferential flat surface defined by the rigid body.

21. The system of claim 16, wherein the rigid body has a visibility window defined within the outwardly facing surface for viewing a target annulus through the window.

25. The system of claim 16, wherein the rigid body is generally formed in a plane with one or more cutting guides formed therein, the annuloplasty ring being attached about the outwardly facing surface by one or more sutures, each suture being secured to the rigid body, threaded through the annuloplasty ring and gassed over one of the cutting guides, each cutting guide having a groove such that a middle portion of the corresponding suture spans the groove in a direction generally parallel to the plane and a cutting tool can be inserted into each groove to sever the sutures.

22. The system of claim 22, wherein the rigid body comprises a planar member, and wherein the visibility window comprises an opening formed in the planar member.

23. The system of claim 23, where are a plurality of visibility windows formed in the planar member between spokes extending from the outwardly facing surface to a central location.

24. The system of claim 24, further including a hub joining the spokes at the central location, wherein a handle can be attached to the hub for manipulating the rigid body.

26. The system of claim 26, further including apertures formed in the rigid body and disposed so that each suture extends directly therethrough into the annuloplasty ring and an outer periphery of the annuloplasty ring is un-obstructed for an implant procedure.

27. A system of implanting an annuloplasty ring, comprising:

an assembly of an annuloplasty ring and a rigid body, the rigid body having an outwardly facing surface against which the annuloplasty ring is held using one or more sutures through the ring and into apertures in the rigid body, the ring being positioned such that an outer periphery thereof defines an outermost surface of the ring/rigid body assembly, each suture being attached to the rigid body with a portion passing through the apertures and the ring, wherein the rigid body can be detached from the annuloplasty ring by severing the suture and removing the rigid body and severed suture from the secured ring.

28. The system of claim 28, wherein the outwardly facing surface is a circumferential groove defined by the rigid body.

29. The system of claim 28, wherein the outwardly facing surface is a circumferential trough defined by the rigid body.

30. The system of claim 28, wherein the outwardly facing surface is a circumferential depression defined by the rigid body.

31. The system of claim 28, wherein the outwardly facing surface is a circumferential channel defined by the rigid body.

32. The system of claim 28, wherein the outwardly facing surface is a circumferential flat surface defined by the rigid body.

33. The system of claim 28, wherein the rigid body has a visibility window defined within the outwardly facing surface for viewing a target annulus through the window.

37. The system of claim 28, wherein the rigid body is generally formed in a plane with one or more cutting guides formed therein, the annuloplasty ring being attached about the outwardly facing surface by one or more sutures, each suture being secured to the rigid body, threaded through the annuloplasty ring and passed over one of the cutting guides, each cutting guide having a groove such that the corresponding suture spans the groove and a cutting tool can be inserted into each groove to sever the sutures.

38. The system of claim 28, wherein the apertures are formed in the rigid body and disposed so that the sutures extend directly therethrough into the annuloplasty ring and an outer periphery of the annuloplasty ring is un-obstructed for an implant procedure.

34. The system of claim 34, wherein the rigid body comprises a planar member, and wherein the visibility window comprises an opening formed in the planar member.

35. The system of claim 35, wherein there are a plurality of visibility windows formed in the planar member between spokes extending from the outwardly facing surface to a central location.

36. The system of claim 36, further including a hub joining the spokes at the central location, wherein a handle can be attached to the hub for manipulating the rigid body.