BIMODAL TRICUSPID ANNULOPLASTY RING

• US 20110160849A1
• Filed: 12/21/2010
• Published: 06/30/2011
• Est. Priority Date: 12/22/2009
• Status: Abandoned Application

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Curtis, Alison S., Carpentier, Alain F.
• Application Number:
  US12/975,092
• Publication Number:
  US 20110160849A1
• Time in Patent Office: Days
• US Class Current: 623/2.19
• CPC Class Codes: A61F 2/2445 Annuloplasty rings in direct contact with the valve annulus

Abstract

A prosthetic remodeling tricuspid annuloplasty ring having two free ends can be configured to more accurately mimic native valve anatomy (e.g., shape) and movement during the cardiac cycle. A tricuspid ring can be provided with a substantially elliptical shape in the X-Y plane, and a bimodal saddle shape in the Z direction. The tricuspid ring can be configured to contract and expand during each cardiac cycle such that the area of the orifice and/or the diameter of the ring decrease with each contraction. Further, the elevation or non-planarity of the bimodal saddle shape can increase with each contraction. Movement of the tricuspid ring can vary in each different segment of the tricuspid ring. Tricuspid annuloplasty rings can be provided in a set, with changing ratios of diameter, changing out-of-plane static amplitudes, and changing amounts of dynamic movement in each different size of tricuspid ring.

Claims

1. A tricuspid annuloplasty ring for use in a tricuspid valve repair procedure, the tricuspid annulus having peripheral landmarks as viewed from above in a clockwise direction of an antero-septal commissure, anterior leaflet, posterior commissure, posterior leaflet, postero-septal commissure, and septal leaflet, comprising a core made of a relatively rigid material defined by:

a septal-anterior segment located around portions of the septal and anterior leaflets when implanted having a free first end and a second end;

an anterior-lateral segment located around portions of the anterior and posterior leaflets when implanted having a second end and a first end adjacent the second end of the septal-anterior segment;

a lateral-posterior segment located around the posterior leaflet when implanted having a second end and a first end adjacent the second end of the anterior-lateral segment; and

a posterior-septal segment located around the septal leaflet when implanted having a free second end and a first end adjacent the second end of the lateral-posterior segment,

wherein the ring is configured such that a gap exists between the free first end of the septal-anterior segment and the free second end of the posterior-septal segment, the ring having a bimodal saddle shape having a first and second high point and a first and second low point, the first high point being located within the septal-anterior segment, the second high point being located within the lateral-posterior segment, the first low point being located within the anterior-lateral segment, and the second low point being located within the posterior-septal segment.

2. The tricuspid annuloplasty ring according to claim 1, wherein the ratio of the greatest length between any two points on an interior surface of the ring to the greatest width between any two points on the interior of the ring is at least 1.56.

3. The tricuspid annuloplasty ring according to claim 1, further comprising a subvalvular apparatus.

4. The tricuspid annuloplasty ring according to claim 1, wherein the ring is configured to substantially restore the anatomically correct shape in all three dimensions of a native tricuspid valve in which the ring is designed to be implanted.

5. The tricuspid annuloplasty ring according to claim 1, wherein when the ring is positioned within a native tricuspid valve, the first high point of the ring is approximately positioned adjacent the septal-anterior commissure of the native tricuspid valve and the second high point of the ring is approximately positioned adjacent the center of the posterior leaflet of the native tricuspid valve.

6. The tricuspid annuloplasty ring according to claim 5, wherein the elevation of the first high point is from about 0.5 mm to about 4 mm.

7. The tricuspid annuloplasty ring according to claim 5, wherein the elevation of the second high point is from about 2 mm to about 4 mm.

8. The tricuspid annuloplasty ring according to claim 1, wherein when the ring is positioned within a native tricuspid valve, the first low point of the ring is approximately positioned adjacent the center of the anterior leaflet of the native tricuspid valve and the second low point of the ring is approximately positioned adjacent the center of the septal leaflet of the native tricuspid valve.

9. The tricuspid annuloplasty ring according to claim 8, wherein the elevation of the first low point is from about −

2 mm to about −

4 mm.

10. The tricuspid annuloplasty ring according to claim 8, wherein the elevation of the second low point is from about −

1 mm to about −

4 mm.

11. The tricuspid annuloplasty ring according to claim 1, wherein the ring is configured to move during the normal cardiac cycle once implanted in a native valve, such that a first elevation of one or more of the high points and a second elevation of one or more of the low points change during each cardiac cycle.

12. The tricuspid annuloplasty ring according to claim 1, wherein the ring is configured to move during the normal cardiac cycle once implanted in a native valve, such that the diameter of the ring changes during each cardiac cycle.

13. The tricuspid annuloplasty ring according to claim 1, wherein the ring is configured to move during the normal cardiac cycle once implanted in a native valve, such that the area of an orifice defined by the ring changes during each cardiac cycle.

22. The tricuspid annuloplasty ring according to claim 5, wherein the elevation of the local high point is from about 0.5 mm to about 4 mm.

23. The tricuspid annuloplasty ring according to claim 5, further including a second local high point located within the lateral-posterior segment and having an elevation of from about 2 mm to about 4 mm.

24. The tricuspid annuloplasty ring according to claim 8, wherein the elevation of the local low point is from about −

2 mm to about −

4 mm.

25. The tricuspid annuloplasty ring according to claim 8, further including a second local low point located within the posterior-septal segment and having an elevation of from about −

1 mm to about −

4 mm.

14. A set of a plurality of tricuspid annuloplasty rings of different sizes, each ring being adapted for use in a tricuspid valve repair procedure, the tricuspid annulus having peripheral landmarks as viewed from above in a clockwise direction of an antero-septal commissure, anterior leaflet, posterior commissure, posterior leaflet, postero-septal commissure, and septal leaflet, wherein each ring comprises a core made of a relatively rigid material defined by:

a septal-anterior segment located around portions of the septal and anterior leaflets when implanted having a free first end and a second end;

an anterior-lateral segment located around portions of the anterior and posterior leaflets when implanted having a second end and a first end adjacent the second end of the septal-anterior segment;

a lateral-posterior segment located around the posterior leaflet when implanted having a second end and a first end adjacent the second end of the anterior-lateral segment; and

a posterior-septal segment located around the septal leaflet when implanted having a free second end and a first end adjacent the second end of the lateral-posterior segment,

wherein the ring is configured such that a gap exists between the free first end of the septal-anterior segment and the free second end of the posterior-septal segment, the ring having a bimodal saddle shape having a first and second high point and a first and second low point, the first high point being located within the septal-anterior segment, the second high point being located within the lateral-posterior segment, the first low point being located within the anterior-lateral segment, and the second low point being located within the posterior-septal segment.

15. The set of tricuspid annuloplasty rings according to claim 14, wherein each ring has a ring ratio of the greatest length between any two points on an interior surface of the ring to the greatest width between any two points on the interior of the ring, and wherein the ratio is different for each ring in the set.

16. The set of tricuspid annuloplasty rings according to claim 15, wherein when the set of rings is ordered from the smallest ring to the largest ring, the change in the ring ratio from one ring to the next largest ring is not constant.

17. The set of tricuspid annuloplasty rings according to claim 14, wherein an elevation of the first and second high points varies with each different sized ring in the set.

18. The set of tricuspid annuloplasty rings according to claim 17, wherein each ring is configured to move during the normal cardiac cycle when implanted in an native valve such that the elevation of the first and second high points changes during each cardiac cycle, and wherein each ring is configured to undergo a larger change in the elevation of the first and second high points than the next smaller ring in the set.

19. The set of tricuspid annuloplasty rings according to claim 14, wherein the elevation of the first and second low points varies with each different sized ring in the set.

20. The set of tricuspid annuloplasty rings according to claim 19, wherein each ring is configured to move during the normal cardiac cycle when implanted in an native valve such that the elevation of the first and second low points changes during each cardiac cycle, and wherein each ring is configured to undergo a larger change in the elevation of the first and second low points than the next smaller ring in the set.

21. A tricuspid annuloplasty ring for use in a tricuspid valve repair procedure, the tricuspid annulus having peripheral landmarks as viewed from above in a clockwise direction of an antero-septal commissure, anterior leaflet, posterior commissure, posterior leaflet, postero-septal commissure, and septal leaflet, comprising a core made of a relatively rigid material defined by:

a septal-anterior segment located around portions of the septal and anterior leaflets when implanted having a free first end and a second end;

an anterior-lateral segment located around portions of the anterior and posterior leaflets when implanted having a second end and a first end adjacent the second end of the septal-anterior segment;

a lateral-posterior segment located around the posterior leaflet when implanted having a second end and a first end adjacent the second end of the anterior-lateral segment; and

a posterior-septal segment located around the septal leaflet when implanted having a free second end and a first end adjacent the second end of the lateral-posterior segment,

wherein the ring is configured such that a gap exists between the free first end of the septal-anterior segment and the free second end of the posterior-septal segment, the ring having an undulating contour with a local high point located within the septal-anterior segment at the antero-septal commissure when implanted, and a local low point located within the posterior-septal segment.