Annuloplasty ring for ischemic mitral valve insuffuciency

• US 7,935,145 B2
• Filed: 06/30/2004
• Issued: 05/03/2011
• Est. Priority Date: 05/17/2001
• Status: Expired due to Fees

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: McCarthy, Patrick, Maisano, Francesco, Alfieri, Ottavio, Redaelli, Alberto, Carpentier, Alain F.
• Primary Examiner(s): Isabella; David
• Assistant Examiner(s): SCHILLINGER, ANN M
• Application Number:
  US10/882,031
• Publication Number:
  US 20050131533A1
• Time in Patent Office: 2,498 Days
• Field of Search: 623 236- 242
• US Class Current: 623/2.36
• CPC Class Codes: A61F 2/2409 Support rings therefor, e.g. for connecting valves to tissue annuloplasty rings A61F2/2442
• CPC Class Codes: A61F 2/2448 D-shaped rings
• CPC Class Codes: A61F 2/246 Devices for obstructing a leak through a native valve in a closed condition

Abstract

A remodeling mitral annuloplasty ring with a reduced anterior-to-posterior dimension to restore coaptation between the mitral leaflets in mitral valve insufficiency (IMVI). The ring has a generally oval shaped body with a major axis perpendicular to a minor axis, both perpendicular to a blood flow axis. An anterior section lies between anteriolateral and posteriomedial trigones, while a posterior section defines the remaining ring body and is divided into P1, P2, and P3 segments corresponding to the three scallops of the same nomenclature in the posterior leaflet of the mitral valve. The anterior-to-posterior dimension of the ring body is reduced from conventional rings; such as by providing, in atrial plan view, a pulled-in P3 segment. Viewed another way, the convexity of the P3 segment is less pronounced than the convexity of the P1 segment. In addition, the ring body may have a downwardly deflected portion in the posterior section, preferably within the P2 and P3 segments. The downwardly deflected portion may have an apex which is the lowest elevation of the ring body and may be offset with respect to the center of the downwardly deflected portion toward the P1 segment. A sewing cuff may have an enlarged radial dimension of between 5-10 cm, or only a portion of the sewing cuff may be enlarged.

Claims

1. An annuloplasty ring for implantation in a mitral valve annulus designed to correct ischemic mitral valve insufficiency, the native mitral valve being located at the orifice between the left atrium and left ventricle and having two leaflets which coapt to form a one-way valve within an overall orifice area, the annuloplasty ring comprising:

a generally oval shaped ring body having a metallic core and oriented about a central flow axis, the flow axis defining an upward direction and a downward direction, the downward direction corresponding to the direction of blood flow through the mitral valve annulus from the left atrium to the left ventricle, and wherein in plan view as seen along the flow axis the ring body has a major axis perpendicular to a minor axis, the major and minor axes being perpendicular to the flow axis,

the ring body having, in atrial plan view, an anterior section generally defined between an anterolateral trigone and a posteromedial trigone, and a posterior section around the remaining periphery of the ring body and between trigones, the posterior section being divided into three sequential segments, (P1), (P2), and (P3), starting from the anterolateral trigone and continuing in a counterclockwise direction, wherein the minor axis intersects both the anterior section and the (P2) segment of the posterior section, and wherein a portion of the posterior section deflects downward with respect to the remaining sections of the ring body to a single apex; and

,

wherein, given a predetermined major axis dimension, the ratio of the minor axis dimension to the major axis dimension is less than 3;

4.

2. The annuloplasty ring of claim 1, wherein the ring body in plan view has an asymmetric configuration across the minor axis with the convexity of the (P1) segment of the posterior section being greater than the convexity of the (P3) segment.

3. The annuloplasty ring of claim 2, wherein the (P3) segment has a convexity that is pulled-in by about 89% in comparison to the convexity of the (P1) segment as measured along lines emanating between the closest points along the respective segments and a central reference point at the intersection of the anterior section and the minor axis.

4. The annuloplasty ring of claim 1, wherein the portion of the posterior section that is deflected downward is located exclusively within the (P2) and (P3) segments.

5. The annuloplasty ring of claim 1, wherein the portion of the posterior section that is deflected downward is located within the (P2) and (P3) segments, and wherein the apex in the downwardly deflected portion is the lowest elevation of the ring body, and wherein the apex is off-center in the downwardly deflected portion toward the (P1) segment of the ring body such that, in a posterior elevational view, a transition of the ring body between the (P1) segment and the apex extends along a shorter distance around the ring body than a transition of the ring body between the apex and the remaining portion of the (P3) segment.

6. The annuloplasty ring of claim 5, wherein in posterior elevational view the transition of the ring body between the apex and the remaining, generally planar portion of the (P3) segment is substantially linear.

7. The annuloplasty ring of claim 1, wherein in atrial plan view the (P3) segment is substantially linear.

8. The annuloplasty ring of claim 1, wherein the ring body is constructed to be more flexible in the posterior section than in the anterior section.

9. The annuloplasty ring of claim 1, wherein the dimension of the ring body is reduced along the minor axis by an inwardly deflected portion in the anterior section.

10. The annuloplasty ring of claim 1, further including a sewing cuff around the ring body having an enlarged portion around the periphery of the ring body that can accommodate two radially adjacent rows of suture lines.

11. The annuloplasty ring of claim 10, further including markings provided on the sewing cuff to indicate placement of the two radially adjacent rows of suture lines.

12. The annuloplasty ring of claim 10, wherein the enlarged portion of the sewing cuff extends around less than the entire periphery of the ring.

13. The annuloplasty ring of claim 12, wherein the enlarged portion is at least partly in the (P3) segment.

14. The annuloplasty ring of claim 1, wherein the ratio of the minor axis dimension to the major axis dimension is made less than 3:

4 by reducing the absolute value of the minor axis dimension by between about 2-4 mm from an exact 3;

4 ratio so as to restore the coaptation between the two leaflets without reducing excessively the overall orifice area of the annuloplasty ring.

15. The annuloplasty ring of claim 1, wherein the ratio of the minor axis dimension to the major axis dimension is about 3:

5.

16. The annuloplasty ring of claim 1, wherein the metallic core is titanium.

17. The annuloplasty ring of claim 1, wherein the metallic core comprises concentric bands.

18. An annuloplasty ring for implantation in a mitral valve annulus designed to correct ischemic mitral valve insufficiency, the native mitral valve being located at the orifice between the left atrium and left ventricle and having two leaflets which coapt to form a one-way valve within an overall orifice area, the annuloplasty ring comprising:

a generally oval shaped ring body having a metallic core and oriented about a central flow axis, the flow axis defining an upward direction and a downward direction, the downward direction corresponding to the direction of blood flow through the mitral valve annulus from the left atrium to the left ventricle, and wherein in plan view as seen along the flow axis the ring body has a major axis perpendicular to a minor axis, the major and minor axes being perpendicular to the flow axis,

the ring body having in atrial plan view an anterior section generally defined between an anterolateral trigone and a posteromedial trigone, and a posterior section around the remaining periphery of the ring body and between trigones, the posterior section being divided into three sequential segments, (P1), (P2), and (P3), starting from the anterolateral trigone and continuing in a counterclockwise direction, wherein the minor axis intersects both the anterior section and the (P2) segment of the posterior section; and

,

wherein a portion of the posterior section deflects downward with respect to the remaining sections of the ring body, and wherein the ring body in plan view has an asymmetric configuration across the minor axis with the convexity of the (P1) segment of the posterior section being the greater than the convexity of the (P3) segment.

19. The annuloplasty ring of claim 18, wherein the (P3) segment has a convexity that is pulled-in by about 89% in comparison to the convexity of the (P1) segment as measured along lines emanating between the closest points along the respective segments and a central reference point at the intersection of the anterior section and the minor axis.

20. The annuloplasty ring of claim 18, wherein the downwardly deflected portion of the ring body is located within the (P2) and (P3) segments.

21. The annuloplasty ring of claim 20, wherein the downwardly deflected portion including an apex which is the lowest elevation of the ring body, and wherein the apex is off-center in the downwardly deflected (P2) portion toward the (P1) segment of the ring body such that, in a posterior elevational view, a transition of the ring body between the non-downwardly-deflected (P1) segment and the apex extends along a shorter distance around the ring body than a transition of the ring body between the apex and a non-downwardly-deflected portion of the (P3) segment.

22. The annuloplasty ring of claim 21, wherein in posterior elevational view the transition of the ring body between the apex and the non-downwardly-deflected portion of the (P3) segment is substantially linear.

23. The annuloplasty ring of claim 21, wherein in atrial plan view the (P3) segment is substantially linear.

24. The annuloplasty ring of claim 18, wherein the ring body is rigid.

25. The annuloplasty ring of claim 18, wherein the ring body is constructed to be more flexible in the posterior section than around the remainder of the ring body.

26. The annuloplasty ring of claim 18, wherein the dimension of the ring body is reduced along the minor axis by an inwardly deflected portion in the anterior section.

27. The annuloplasty ring of claim 18, further including a sewing cuff around the ring body having an enlarged portion around the periphery of the ring body that can accommodate two radially adjacent rows of suture lines.

28. The annuloplasty ring of claim 27, further including markings provided on the sewing cuff to indicate placement of the two radially adjacent rows of suture lines.

29. The annuloplasty ring of claim 27, wherein the enlarged portion of the sewing cuff extends around less than the entire periphery of the ring.

30. The annuloplasty ring of claim 29, wherein the enlarged portion is at least partly in the (P3) segment.

31. The annuloplasty ring of claim 18, wherein the ratio of the minor axis dimension to the major axis dimension is less than 3:

4.

32. The annuloplasty ring of claim 31, wherein the ratio of the minor axis dimension to the major axis dimension is about 3:

5.

33. The annuloplasty ring of claim 18, wherein the metallic core is titanium.

34. The annuloplasty ring of claim 18, wherein the metallic core comprises concentric bands.

35. An annuloplasty ring for implantation in a mitral valve annulus designed to correct ischemic mitral valve insufficiency, the native mitral valve being located at the orifice between the left atrium and left ventricle and having two leaflets which coapt to form a one-way valve within an overall orifice area, the annuloplasty ring comprising:

a generally oval shaped ring body having a metallic core and oriented about a central flow axis, the flow axis defining an upward direction and a downward direction, the downward direction corresponding to the direction of blood flow through the mitral valve annulus from the left atrium to the left ventricle, and wherein in plan view as seen along the flow axis the ring body has a major axis perpendicular to a minor axis, the major and minor axes being perpendicular to the flow axis,

the ring body having in atrial plan view an anterior section generally defined between an anterolateral trigone and a posteromedial trigone, and a posterior section around the remaining periphery of the ring body and between trigones, the posterior section being divided into three sequential segments, (P1), (P2), and (P3), starting from the anterolateral trigone and continuing in a counterclockwise direction, wherein the minor axis intersects both the anterior section and the (P2) segment of the posterior section; and

,

wherein a portion of the posterior section located exclusively within the (P2) and (P3) segments deflects downward with respect to the remaining sections of the ring body.

36. The annuloplasty ring of claim 35, wherein the downwardly deflected portion including an apex which is the lowest elevation of the ring body, and wherein the apex is off-center in the downwardly deflected portion toward the (P1) segment of the ring body such that, in a posterior elevational view, a transition of the ring body between the non-downwardly-deflected (P1) segment and the apex extends along a shorter distance around the ring body than a transition of the ring body between the apex and a non-downwardly-deflected portion of the (P3) segment.

37. The annuloplasty ring of claim 36, wherein in posterior elevational view the transition of the ring body between the apex and the non-downwardly-deflected portion of the (P3) segment is substantially linear.

38. The annuloplasty ring of claim 36, wherein in atrial plan view the (P3) segment is substantially linear.

39. The annuloplasty ring of claim 35, wherein the metallic core is titanium.

40. The annuloplasty ring of claim 35, wherein the metallic core comprises concentric bands.