Annuloplasty ring delivery method

• US 6,558,416 B2
• Filed: 03/06/2001
• Issued: 05/06/2003
• 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:
  US09/800,074
• Publication Number:
  US 20010010018A1
• Time in Patent Office: 791 Days
• Field of Search: 673/2.11, 673/2.36, 673/2.37
• 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 way 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. A method of implanting an annuloplasty ring, comprising:

providing a rigid template defining at least a partial circumferential edge about which the annuloplasty ring may be fitted, the template having a plurality of cutting guides formed therein adjacent the partial circumferential edge, the annuloplasty ring being tautly attached about the circumferential edge by a plurality of sutures, both ends of each suture being secured to the rigid template with a middle portion threaded through the annuloplasty ring and passing over one of the cutting guides;

introducing the annuloplasty ring and template to an anatomical location;

implanting the annuloplasty ring at the anatomical location;

de-coupling the template from the annuloplasty ring by severing each suture middle portion at the respective cutting guide; and

removing the template from proximity with the anatomical location.

2. The method of claim 1, further comprising:

providing a handle coupled to the template;

providing a tethered connection between the handle and template; and

wherein the step of removing the template from proximity with the anatomical location includes using the tethered connection between the handle and template.

3. The method 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 method of claim 3, wherein the handle attaches to the template with sutures, and further including the step of severing the sutures attaching the handle to template.

5. The method claim 1, wherein the step of providing comprises positioning the annuloplasty ring in a circumferential groove defined by the template.

6. The method of claim 1, wherein the step of providing comprises positioning the annuloplasty ring in a circumferential trough defined by the template.

7. The method claim 1, wherein the step of providing comprises positioning the annuloplasty ring in a circumferential depression defined by the template.

8. The method claim 1, wherein the step of providing comprises positioning the annuloplasty ring in a circumferential channel defined by the template.

9. The method claim 1, wherein the step of providing comprises positioning the annuloplasty ring around a circumferential flat surface defined by the template.

10. The method claim 1, wherein the template has a visibility window defined within the circumferential edge, and the step of introducing the annuloplasty ring and template to an anatomical location includes viewing the anatomical location through the window.

11. The method 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.

12. The method 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, and the step of introducing the annuloplasty ring and template to an anatomical location includes viewing the anatomical location through the windows.

13. The method of claim 12, further including a hub joining the spokes at the central location, the method including attaching a handle to the hub for manipulating the template.

14. The method of claim 1, wherein the rigid template is generally formed in a plane, and the cutting guides extend and have a groove formed therein such that the middle portion of each suture spans the groove in a direction generally parallel to the plane, the method including passing a cutting tool into the groove to sever the suture.

15. The method 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 during the step of implantation.

16. A method of implanting an annuloplasty ring, comprising:

providing a rigid body having an outwardly facing surface against which the annuloplasty ring is positioned and held tautly 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;

delivering the ring/rigid body assembly to a valve annulus;

securing the ring to the annulus while the ring is held in the fixed shape on the rigid body; and

detaching the rigid body from the ring by severing the suture and removing the rigid body and severed suture from the secured ring.

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

18. The method claim 16, wherein the outwardly facing surface is a circumferential trough defined by the rigid body.

19. The method claim 16, wherein the outwardly facing surface is a circumferential depression defined by the rigid body.

20. The method claim 16, wherein outwardly facing surface is a circumferential channel defined by the rigid body.

21. The method claim 16, wherein the outwardly facing surface is a circumferential flat surface defined by the rigid body.

22. The method claim 16, wherein the rigid body has a visibility window defined within the outwardly facing surface, and the step of delivering the ring/rigid body assembly to a valve annulus includes viewing the annulus through the window.

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

24. The method of claim 23, 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, and the step of delivering the ring/rigid body assembly to a valve annulus includes viewing the annulus through the windows.

25. The method of claim 24, further including a hub joining the spokes at the central location, the method including attaching a handle to the hub for manipulating the rigid body.

26. The method of claim 16, wherein the rigid body is generally formed in a plane with a plurality of cutting guides formed therein, the annuloplasty ring being tautly attached about the outwardly facing surface by a plurality of the sutures, both ends of each suture being secured to the rigid body with a middle portion threaded through the annuloplasty ring and passing over one of the cutting guides, each cutting guide having a groove such that the middle portion of each suture spans the groove in a direction generally parallel to the plane, the method including passing a cutting tool into the groove to sever the suture.

27. The method of claim 26, further including apertures 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 during the step of securing the ring to the annulus.

28. A method of implanting an annuloplasty ring, comprising:

providing 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 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 two points on the rigid body with a portion passing through the apertures and the ring;

delivering the ring/rigid body assembly to a valve annulus;

securing the ring to the annulus while the ring is held on the rigid body; and

severing each suture between the two attached points and removing the rigid body and severed sutures from the secured ring.

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

30. The method claim 28, wherein the outwardly facing surface is a circumferential trough defined by the rigid body.

31. The method claim 28, wherein the outwardly facing surface is a circumferential depression defined by the rigid body.

32. The method claim 28, wherein the outwardly facing surface is a circumferential channel defined by the rigid body.

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

34. The method claim 28, wherein the rigid body has a visibility window defined within the outwardly facing surface, and the step of delivering the ring/rigid body assembly to a valve annulus includes viewing the annulus through the window.

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

36. The method 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, and the step of delivering the ring/rigid body assembly to a valve annulus includes viewing the annulus through the windows.

37. The method of claim 36, further including a hub joining the spokes at the central location, the method including attaching a handle to the hub for manipulating the rigid body.

38. The method of claim 28, wherein the rigid body is generally formed in a plane with a plurality of cutting guides formed therein, the annuloplasty ring being tautly attached about the outwardly facing surface by a plurality of said sutures, both ends of each suture being secured to the rigid body with a middle portion threaded through the annuloplasty ring and passing over one of the cutting guides, each cutting guide having a groove such that the middle portion of each suture spans the groove in a direction generally parallel to the plane, the method including passing a cutting tool into the groove to sever the suture.

39. The method 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 during the step of securing the ring to the annulus.