Annuloplasty ring delivery system

• US 6,283,993 B1
• Filed: 05/27/1998
• Issued: 09/04/2001
• Est. Priority Date: 07/31/1989
• Status: Expired due to Term

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Nguyen, Than, Cosgrove, Delos M.
• Primary Examiner(s): Willse, David H.
• Application Number:
  US09/085,944
• Time in Patent Office: 1,196 Days
• Field of Search: 623/2, 623/900, 623/2.11, 623/904
• 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. A holder in combination with an annuloplasty ring, comprising:

an annuloplasty ring;

a rigid body defining at least a partial circumferential edge about which the annuloplasty ring may be fitted, the body having a visibility window defined within the circumferential edge;

a plurality of cutting guides formed in the body adjacent the circumferential edge; and

a plurality of sutures tautly attaching the annuloplasty ring about the circumferential edge, both ends of each suture being secured to the rigid body with a middle portion threaded through the annuloplasty ring.

2. The combination of claim 1, wherein the plurality of cutting guides are evenly spaced about the rigid body circumferential edge so that the annuloplasty ring is tautly attached about the circumferential edge in a uniform manner.

3. The combination of claim 1, wherein the rigid body is generally formed in a plane, and the cutting guides extend generally normal to the plane.

4. The combination of claim 3, wherein the cutting guides each comprises a raised platform having a first groove formed therein across which one of the sutures passes.

5. The combination of claim 4, wherein the cutting guides each further comprises a second groove extending generally perpendicular to the first groove.

6. The combination of claim 5, wherein the second groove of each cutting guide is deeper than the first groove.

7. The combination of claim 1, further including apertures formed in the circumferential edge and disposed so that the sutures extend generally from the rigid body through an inner circumference of the annuloplasty ring so that the outer circumference of the annuloplasty ring is unobstructed to aid in implantation.

8. The combination of claim 1, wherein the rigid body comprises a planar member extending generally in a plane within the circumferential edge, and wherein the visibility window comprises an opening formed in the planar member.

9. The combination of claim 8, wherein there are a plurality of visibility windows formed in the planar member by spokes extending from the circumferential edge to a central location.

10. The combination of claim 9, further including a hub joining the spokes at the central location, the hub being adapted to attach to a handle for manipulating the holder.

11. The combination of claim 10, further including a handle coupled to the hub and formed to be gripped during the placement of sutures through the annuloplasty ring.

12. The combination of claim 11, further including a tether extendibly tethering the handle to the body.

13. The combination of claim 12, wherein the tether comprises a spool of a length of filamentous material secured at one end to the body and at an opposite end to the handle.

14. The combination of claim 13, wherein the handle includes a spool housing having a cavity for housing the spool.

15. The combination of claim 1, wherein the circumferential edge is a groove.

16. The combination of claim 1, wherein the circumferential edge is a trough.

17. The combination of claim 1, wherein the circumferential edge is a depression.

18. The combination of claim 1, wherein the circumferential edge is a channel.

19. The combination of claim 1, wherein the circumferential edge is generally flat.

20. A substantially rigid holder in combination with an annuloplasty ring, comprising:

a flexible annuloplasty ring;

a body having an outer edge for holding the flexible annuloplasty ring in a plane around the outer edge;

at least one thread releasably retaining the annuloplasty ring around the outer edge in a taut fashion;

a thread guide on the body spaced from the plane of the annuloplasty ring and including a surface supporting the thread, the thread guide having a cutting guide groove opening at the surface for insertion of a cutting tool therein to cut the thread and thereby release the annuloplasty ring from the holder.

21. The holder of claim 20, wherein the thread guide includes a raised platform having the thread supporting surface and the cutting guide groove.

22. The holder of claim 20, wherein the thread guide includes a second groove receiving the thread, the second groove being defined by surfaces including the thread supporting surface.

23. The holder of claim 22, wherein the cutting guide groove is deeper than the second groove.

24. The holder of claim 22, wherein the cutting guide groove and second groove are substantially perpendicular to each other.

25. The holder of claim 20, wherein an end of the cutting guide groove is closed to stop movement of the tool in an insertion direction.

26. The holder of claim 20, further including:

a plurality of apertures formed in the outer edge;

a plurality of the thread guides formed in the body adjacent the outer edge; and

wherein there are a plurality of the threads passing through the apertures and releasably attaching the annuloplasty ring about the outer edge.

27. The holder of claim 26, wherein the apertures are disposed so that the sutures extend generally from the body through an inner circumference of the annuloplasty ring so that the outer circumference of the annuloplasty ring is unobstructed to aid in implantation.

28. The holder of claim 26, wherein both ends of each thread are secured to the rigid body with a middle portion threaded through the annuloplasty ring.

29. The holder of claim 20, further including a ring mounting surface, the annuloplasty ring being tautly positioned against the ring mounting surface by the thread.

30. The holder of claim 29, wherein the ring mounting surface comprises an outwardly facing channel into which the annuloplasty ring is at least partially fitted.

31. The holder of claim 30, wherein the outwardly facing channel comprises a groove against which the annuloplasty ring is releasably retained by the thread, and wherein the thread is affixed at both ends to the body with a first portion passing through the annuloplasty ring and a second portion passing across the thread guide, the thread being subdivided into two pieces when a cutting tool is inserted in the thread guide, each piece of the thread remaining affixed at one end to the body, with a free portion being pulled from within the annuloplasty ring by displacing the holder away from the annuloplasty ring, thereby releasing the ring from the groove.

32. The holder of claim 20, further including a handle coupled to the body and formed to be gripped during the placement of sutures through the annuloplasty ring.

33. The holder of claim 32, wherein a second thread releasably couples the body to the handle.

34. The holder of claim 33, including a member positioned between the handle and the body and having a handle release groove accessible by a cutting tool to enable the tool to cut the second thread and un-couple the handle from the body.

35. The holder of claim 34, wherein the member includes a raised platform on the body, the platform including the handle release groove.

36. The holder of claim 32, further including a tether extendibly tethering the handle to the body.

37. The holder of claim 36, wherein the tether comprises a spool of a length of filamentous material secured at one end to the body and at an opposite end to the handle.

38. The holder of claim 37, wherein the handle includes a spool housing having a cavity for housing the spool.

39. The holder of claim 38, wherein the spool housing includes first and second opposed slots for receiving dog ears provided on the spool.

40. The combination of claim 20, wherein the outer edge is a groove.

41. The combination of claim 20, wherein the outer edge is a trough.

42. The combination of claim 20, wherein the outer edge is a depression.

43. The combination of claim 20, wherein the outer edge is a channel.

44. The combination of claim 20, wherein the outer edge is generally flat.

45. A holder in combination with an annuloplasty ring, comprising:

an annuloplasty ring;

a body having an outer circumferential edge shaped to match the shape of a healthy anatomical heart valve annulus;

a plurality of apertures in the body spaced around the circumferential edge;

a plurality of cutting guides spaced around the circumferential edge; and

a plurality of sutures securing the annuloplasty ring to the circumferential edge of the body, each suture being secured at both ends to the body and being threaded therebetween through a first aperture, through the annuloplasty ring, through a second aperture, across one of the cutting guides, through a third aperture, again through the annuloplasty ring, and through a fourth aperture.

46. The holder of claim 45, wherein the plurality of cutting guides are evenly spaced about the rigid body circumferential edge so that the annuloplasty ring is tautly attached about the circumferential edge in a uniform manner.

47. The holder of claim 45, further including a handle coupled to the body and formed to be gripped during the placement of sutures through the annuloplasty ring.

48. The holder of claim 47, further including a tether extendibly tethering the handle to the body.

49. The holder of claim 48, wherein the tether comprises a spool of a length of filamentous material secured at one end to the body and at an opposite end to the handle.

50. The holder of claim 49, wherein the handle includes a spool housing having a cavity for housing the spool.

51. The combination of claim 45, wherein the circumferential edge is a groove.

52. The combination of claim 45, wherein the circumferential edge is a trough.

53. The combination of claim 45, wherein the circumferential edge is a depression.

54. The combination of claim 45, wherein the circumferential edge is a channel.

55. The combination of claim 45, wherein the circumferential edge is generally flat.