Methods for repairing mitral valves

• US 10,166,101 B2
• Filed: 06/22/2016
• Issued: 01/01/2019
• Est. Priority Date: 05/17/2001
• Status: Expired due to Fees

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Alfieri, Ottavio, Carpentier, Alain F., Maisano, Francesco, Redaelli, Alberto, McCarthy, Patrick M.
• Primary Examiner(s): Schillinger, Ann
• Application Number:
  US15/190,076
• Publication Number:
  US 20160367366A1
• Time in Patent Office: 923 Days
• 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

Methods of remodeling an abnormal mitral valve with an annuloplasty ring having 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. 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. 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. The ring body may have a downwardly deflected portion in the posterior section. 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 P3 segment.

Claims

1. A method of performing annuloplasty of a native mitral valve having valve leaflets and a condition resulting in diminished valve leaflet coaptation, comprising:

determining that a posterior aspect of a native annulus of the native mitral valve includes an abnormality comprising a depression below a datum plane;

determining a transverse dimension and an anterior-posterior dimension of the native annulus;

selecting for implantation to the native annulus a mitral valve annuloplasty ring having a ring body covered by a suture-permeable sewing cuff, the ring body defining an orifice having a major axis perpendicular to a minor axis, the major and minor axes being generally perpendicular to a flow axis, wherein the ring body is continuous, closed around the orifice and generally rigid so that it retains its shape after implantation in opposition to the stresses that will be imparted by muscles of the heart throughout each beating cycle, and wherein

a) a major axis dimension of the ring body is less than the annulus transverse dimension, and

b) the ring body is configured to compensate for the depression of the posterior aspect of the native annulus and have a ratio of a minor axis dimension of the ring body to the major axis dimension less than the ratio of the anterior-posterior dimension to the transverse dimension of the mitral valve annulus; and

implanting the ring so as to constrict the native annulus and compensate for the depression, thereby restoring healthy coaptation between the leaflets.

2. The method of claim 1, wherein the abnormality comprises dilatation of the posterior aspect of the native annulus.

3. The method of claim 2, wherein the abnormality comprises an asymmetric dilatation of the posterior aspect of the native annulus.

4. The method of claim 1, wherein the continuous ring body is made of a metal selected from the group consisting of a cobalt-nickel alloy, titanium, or a nickel-titanium alloy.

5. The method of claim 1, wherein the minor axis dimension is smaller than the anterior-posterior dimension by about 2-4 mm more than the amount the major axis dimension is smaller than the annulus transverse dimension.

6. The method of claim 1, wherein the ratio of the minor axis dimension to the major axis dimension is less than 3:

4.

7. The method of claim 6, wherein the ratio of the minor axis dimension of the opening to the major axis dimension of the opening is less than or equal to 2.5:

4.

8. The method of claim 1, wherein the ring body has an anterior segment opposite a posterior segment which is divided into P1, P2, and P3 segments, with the minor axis bisecting the P2 segment, and wherein the posterior segment is asymmetric across the minor axis with the P3 segment being located closer to the anterior segment than is the P1 segment.

9. The method of claim 8, wherein the posterior segment has a downward bow.

10. The method of claim 8, wherein the sewing cuff has an enlarged portion around the periphery of the ring body in the P3 segment that can accommodate two radially adjacent rows of suture lines, the method including sewing the ring to the annulus using the sewing cuff and securing the ring with two rows of suture lines at the enlarged portion of the sewing cuff.

11. A method of performing annuloplasty of a mitral valve having valve leaflets and a condition resulting in diminished valve leaflet coaptation comprising:

determining a transverse dimension and an anterior-posterior dimension of the mitral valve annulus;

selecting for implantation to the mitral valve annulus a mitral valve annuloplasty ring having a ring body covered by a suture-permeable sewing cuff, the ring body defining an orifice having a major axis perpendicular to a minor axis, the major and minor axes being generally perpendicular to a flow axis, wherein the ring body is continuous, closed around the orifice and generally rigid so that it retains its shape after implantation in opposition to the stresses that will be imparted by muscles of the heart throughout each beating cycle, and wherein

a) a major axis dimension of the ring body is smaller than the annulus transverse dimension, and

b) wherein the ring body has an anterior segment opposite a posterior segment which is divided into P1, P2, and P3 segments, with the minor axis bisecting the P2 segment, and wherein the posterior segment is asymmetric across the minor axis with the P3 segment being located closer to the anterior segment than is the P1 segment; and

implanting the ring so as to constrict the native annulus and restore healthy coaptation between the leaflets; and

determining that the mitral valve annulus has an abnormality comprising an asymmetrical deformation of the mitral valve annulus caused by an increased distance between the mitral valve annulus and at least one of the papillary muscles, and wherein selecting for implantation to the mitral valve annulus the mitral valve annuloplasty ring comprises selecting a mitral valve annuloplasty ring configured to compensate for the asymmetrical deformation of the mitral valve annulus.

12. The method of claim 11, wherein the mitral valve annulus has an abnormality exhibiting primarily in asymmetric dilatation of a posterior aspect of the mitral annulus.

13. The method of claim 11, wherein the continuous ring body is made of a metal selected from the group consisting of a cobalt-nickel alloy, titanium, or a nickel-titanium alloy.

14. The method of claim 11, wherein the ratio of the minor axis dimension of the ring body to the major axis dimension is less than the ratio of the anterior-posterior dimension to the transverse dimension of the mitral valve annulus.

15. The method of claim 14, wherein the minor axis dimension is smaller than the anterior-posterior dimension by about 2-4 mm more than the amount the major axis dimension is smaller than the annulus transverse dimension.

16. The method of claim 14, wherein the ratio of the minor axis dimension to the major axis dimension is less than 3:

4.

17. The method of claim 16, wherein the ratio of the minor axis dimension of the opening to the major axis dimension of the opening is less than or equal to 2.5:

4.

18. The method of claim 11, wherein the posterior segment has a downward bow.

19. The method of claim 18, wherein a middle point of the downward bow is offset from the minor axis toward the P1 segment.

20. The method of claim 11, wherein the sewing cuff has an enlarged portion around the periphery of the ring body in the P3 segment that can accommodate two radially adjacent rows of suture lines, the method including sewing the ring to the annulus using the sewing cuff and securing the ring with two rows of suture lines at the enlarged portion of the sewing cuff.

21. The method of claim 11, wherein implanting the ring so as to constrict the native annulus and restore healthy coaptation between the leaflets comprises applying the mitral valve annuloplasty ring such that it compensates for the asymmetrical deformation of the mitral valve annulus to restore healthy coaptation.