Apparatus, system, and method for delivering an annuloplasty ring

• US 20060217803A1
• Filed: 03/22/2006
• Published: 09/28/2006
• Est. Priority Date: 03/23/2005
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Ingle, Aaron S., Adzich, W. Vaso, Fann, Hilda Zhang
• Granted Patent: US 7,575,595 B2
• Time in Patent Office: Days
• US Class Current: 623/2.110
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61F 2/2448 D-shaped rings
• CPC Class Codes: A61F 2/2466 Delivery devices therefor

Abstract

An annuloplasty ring holder includes an angled post for improved visibility and access by the surgeon. The post may be configured to be adjusted in angle and rotation. The ring holder can include a relatively open lower template, including relatively narrow extending radial arms with short, generally arcuate ring-retaining distal portions. The invention includes placements of suture holes and cutting wells which, in combination with improved suture routing, afford the user improved access to cutting the suture that is used to retain the annuloplasty ring to the holder.

Claims

1. An annuloplasty ring and holder assembly combination, comprising:

an annuloplasty ring, the annuloplasty ring having a minor axis, a major axis, and a maximum height; and

a ring holder, the holder comprising;

a base structure;

a first radial arm extending from the base structure to a first radial arm inner edge of the annuloplasty ring, the first radial arm extending in a first radial arm direction;

a first arcuate segment secured to a distal end of the first radial arm, the first arcuate segment having a length less than the maximum height of the annuloplasty ring (less than ½

the major axis of the ring?);

a second radial arm extending from the base structure to a second radial arm inner edge of the annuloplasty ring, the second radial arm extending in a second radial direction;

a second arcuate segment secured to a distal end of the second radial arm, the second arcuate segment having a length less than the maximum height of the annuloplasty ring;

wherein the first radial direction is generally opposite to the second radial direction.

2. The combination of claim 1, the holder further comprising:

a first knob extending from the base structure to a first knob inner edge of the annuloplasty ring, the first knob extending in a first knob direction generally along the minor axis of the annuloplasty ring.

3. The combination of claim 2, wherein the base structure has a base width and a base height, and wherein the first knob has a first knob width less than the base width.

4. The combination of claim 2, the holder further comprising:

a second knob extending from the base structure to a second knob inner edge of the annuloplasty ring, the second knob extending in a second knob direction generally along the minor axis of the annuloplasty ring, wherein the second knob direction is generally opposite to the first knob direction.

5. The combination of claim 1, wherein the ring is rigid.

6. The combination of claim 1, wherein the ring is flexible

7. The combination of claim 1, wherein the ring comprises rigid and flexible sections.

8. The combination of claim 1, further comprising:

a handle releasably secured to the base structure.

9. An annuloplasty ring and holder assembly combination, comprising:

an annuloplasty ring, the annuloplasty ring having a minor axis, a major axis, and a maximum height; and

a ring holder, the holder comprising;

a base structure;

a first knob extending from the base structure to a first knob inner edge of the annuloplasty ring, the first knob extending in a first knob direction generally along the minor axis of the annuloplasty ring; and

a second knob extending from the base structure to a second knob inner edge of the annuloplasty ring, the second knob extending in a second knob direction generally along the minor axis of the annuloplasty ring, wherein the second knob direction is generally opposite to the first knob direction.

10. The combination of claim 9, wherein the base structure has a base width and a base height, and wherein the first knob has a first knob maximum width less than the base width.

11. The combination of claim 10, wherein the base structure has a base width and a base height, and wherein the second knob has a second knob maximum width less than the base width.

12. The combination of claim 9, wherein the first knob has a first knob distal width less than the base width.

13. The combination of claim 12, wherein the second knob has a second knob distal width less than the base width.

14. The combination of claim 9, wherein the first knob has a first knob minimum distal width less than the base width.

15. The combination of claim 14, wherein the second knob has a second knob distal width less than the base width.

16. The combination of claim 9, the holder further comprising:

a first radial arm extending from the base structure to a first radial arm inner edge of the annuloplasty ring, the first radial arm extending along the ring major axis in a first radial arm direction;

a first arcuate segment secured to a distal end of the first radial arm, the first arcuate segment having a length less than the maximum height of the annuloplasty ring (less than ½

the major axis of the ring?);

a second radial arm extending from the base structure to a second radial arm inner edge of the annuloplasty ring, the second radial arm extending along the ring major axis in a second radial direction;

a second arcuate segment secured to a distal end of the second radial arm, the second arcuate segment having a length less than the maximum height of the annuloplasty ring;

wherein the first radial direction is generally opposite to the second radial direction.

17. An annuloplasty ring holder, comprising:

a base structure;

a first radial arm extending from the base structure to a first radial arm inner edge of the annuloplasty ring, the first radial arm extending in a first radial arm direction and having a first radial arm length;

a first arcuate segment secured to a distal end of the first radial arm, the first arcuate segment having a length less than the first radial arm length;

a second radial arm extending from the base structure to a second radial arm inner edge of the annuloplasty ring, the second radial arm extending in a second radial direction and having a second radial arm length; and

a second arcuate segment secured to a distal end of the second radial arm, the second arcuate segment having a length less than the second radial arm length.

18. The annuloplasty ring holder of claim 17, wherein the first radial direction is generally opposite to the second radial direction.

19. The annuloplasty ring holder of claim 18, wherein the holder has a maximum width and a maximum height, wherein the maximum width is greater than the maximum height, and the first radial direction and the second radial direction are generally aligned with the maximum width.

20. The annuloplasty ring holder of claim 19, wherein the maximum width is at least twice as large as the maximum height.

21. An annuloplasty ring and holder assembly combination, comprising:

an annuloplasty ring, the annuloplasty ring having a minor axis and a major axis; and

a ring holder comprising a lower template structure, wherein the lower template structure comprises a first suture cutting well and four (4) adjoining first suture holes; and

a first suture line, the first suture line passing through each of the four (4) adjoining first suture holes, across the first suture cutting well, and within or around at least a portion of the annuloplasty ring.

22. The combination of claim 21, wherein the lower template structure comprises a first radially extending structure, the first radially extending structure comprising a first distal portion defining a maximum distance from the center of the lower template structure, and wherein the first cutting well is positioned on or in the first distal portion of the first radially extending structure.

23. The combination of claim 22, wherein the lower template is a generally solid template extending across the inner opening in the annuloplasty ring, and wherein the first radially extending structure comprises a portion of the generally solid lower template.

24. The combination of claim 22, wherein the first radially extending structure comprises a first radially extending arm, and the first distal portion of the first radially extending structure comprises a first generally arcuate section.

25. The combination of claim 21, wherein the ring holder lower template further comprises a second suture cutting well and four (4) adjoining second suture holes, and wherein the combination further comprises:

a second suture line, the second suture line passing through each of the four (4) adjoining second suture holes, across the second suture cutting well, and within or around at least a portion of the annuloplasty ring.

30. An annuloplasty ring and holder assembly combination, comprising:

an annuloplasty ring, the annuloplasty ring having a minor axis, a major axis, and a datum plane; and

an annuloplasty ring holder, the holder comprising;

a lower template structure with the annuloplasty ring releasably secured thereto;

a base post secured to the lower template portion, the base post having a longitudinal axis, wherein the base post longitudinal axis is positioned at an angle from a vertical plane normal to the datum plane of the annuloplasty ring, wherein the combination of claim 21, wherein the lower template structure comprises a first radially extending structure, the first radially extending structure comprising a distal portion defining a maximum distance from the center of the lower template structure, and wherein the first cutting well is positioned on or in the distal portion of the first radially extending structure.

31. The combination of claim 30, wherein the base post longitudinal axis is positioned at an angle between 10 and 15 degrees from the vertical plane normal to the datum plane of the annuloplasty ring.

32. The combination of claim 30, wherein the base post is secured to the lower template portion via an adjustable attachment mechanism, whereby the adjustable attachment mechanism is configured to permit adjustment of the angle between base post longitudinal axis and the vertical plane normal to the datum plane of the annuloplasty ring.

33. The combination of claim 32, wherein the adjustable attachment mechanism is configured to permit rotational adjustment.

34. The combination of claim 32, wherein the adjustable attachment mechanism comprises a releasable lock and one or more interlocking toothed fittings.

35. The combination of claim 32, further comprising:

a handle releasably secured to the base post, the handle comprising a adjustable attachment mechanism control configured to control the adjustable attachment mechanism.

36. The combination of claim 35, wherein the adjustable mechanism control is positioned on a proximal portion of the handle.

26. A ring holder, comprising:

a ring holder comprising a lower template structure, wherein the lower template structure comprises a first radially extending structure, the first radially extending structure comprising a first distal portion defining a maximum distance from the center of the lower template structure, the first distal portion of the first radially extending structure comprising a first suture cutting well and two (2) adjoining first suture holes.

27. The ring holder of claim 26, wherein the lower template structure further comprises a second radially extending structure, the second radially extending structure comprising a second distal portion defining a maximum distance from the center of the lower template structure, the second distal portion of the second radially extending structure comprising a second suture cutting well and two (2) adjoining second suture holes, and wherein the first radially extending structure extends from the center of the lower template in a first direction, the second radially extending structure extends from the center of the lower template structure in a second direction, and the first direction is opposite to the second direction.

28. The ring holder of claim 27, wherein the lower template is a generally solid template having a maximum height and a maximum width, and the first cutting well and the second cutting well are positioned on the solid template adjacent opposing ends of the maximum width.

29. The ring holder of claim 27, wherein the first radially extending structure comprises a first radially extending arm, and the first distal portion of the first radially extending structure comprises a first generally arcuate section, and wherein the second radially extending structure comprises a second radially extending arm, and the second distal portion of the second radially extending structure comprises a second generally arcuate section.