Annuloplasty Rings for Repair of Abnormal Mitral Valves

• US 20110301704A1
• Filed: 04/26/2011
• Published: 12/08/2011
• Est. Priority Date: 05/17/2001
• Status: Abandoned Application

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Alfieri, Ottavio, Carpentier, Alain F., Maisano, Francesco, McCarthy, Patrick, Redaelli, Alberto
• Application Number:
  US13/094,145
• Publication Number:
  US 20110301704A1
• Time in Patent Office: Days
• 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 labeled and indicated for implantation in a mitral valve annulus having a clinically measured native annulus “

size”

corresponding to a transverse dimension across its orifice along a transverse axis, the annulus further defining an anterior-posterior dimension across its orifice perpendicular to the transverse axis, the annuloplasty ring comprising;

a continuous, closed generally rigid body covered with a sewing cuff, wherein the rigid body forms a peripheral shape about an opening 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;

wherein in plan view as seen along the flow axis the opening defined by the ring body has a major axis perpendicular to a minor axis, the major and minor axes being generally perpendicular to the flow axis;

wherein the ring body is adapted for implantation in a mitral valve annulus having a transverse dimension and an anterior-posterior dimension, and a ratio of the minor axis dimension to the major axis dimension is smaller than a ratio of the anterior-posterior dimension to the transverse dimension of the mitral valve annulus, so as to constrict the native annulus and restore the coaptation between valve leaflets without reducing excessively the overall orifice area of the annuloplasty ring.

2. The annuloplasty ring of claim 1, wherein the ring body is “

downsized”

by reducing the minor axis dimension by between about 2-4 mm relative to the corresponding anterior-posterior dimension of the annulus.

3. The annuloplasty ring of claim 1, wherein the major axis dimension is smaller than the measured transverse dimension of the annulus.

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

4.

5. The annuloplasty ring of claim 4, 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.

6. The annuloplasty ring of claim 1, wherein the ring body comprises a metal.

7. The annuloplasty ring of claim 6, wherein the metal is titanium.

8. The annuloplasty ring of claim 1, wherein the sewing cuff around the ring body has an enlarged portion around the periphery of the ring body that can accommodate two radially adjacent rows of suture lines.

9. The annuloplasty ring of claim 8, further including markings provided on the sewing cuff to indicate placement of the two radially adjacent rows of suture lines.

10. A annuloplasty ring labeled and indicated for implantation in a mitral valve annulus having a clinically measured native annulus “

size”

given in even mm increments corresponding to a transverse dimension across its orifice along a transverse axis, the annulus further defining an anterior-posterior dimension across its orifice perpendicular to the transverse axis, the annuloplasty ring comprising;

a continuous, closed generally rigid body covered with a sewing cuff, wherein the rigid body forms a peripheral shape about an opening 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;

wherein in plan view as seen along the flow axis the opening defined by the ring body has a major axis perpendicular to a minor axis, the major and minor axes being generally perpendicular to the flow axis;

wherein the ring body is adapted for implantation in a mitral valve annulus having a transverse dimension and an anterio-posterior dimension and the ring body is “

downsized”

with the peripheral shape smaller than the measured annulus so as to constrict the native annulus when implanted, and wherein the ring body is reduced in size along the minor axis relative to the corresponding anterior-posterior dimension of the annulus a greater amount than the ring body is reduced in size along the major axis relative to the transverse dimension of the annulus.

11. The annuloplasty ring of claim 10, wherein the ring body is “

downsized”

by reducing the minor axis dimension by between about 2-4 mm relative to the corresponding anterior-posterior dimension of the annulus.

12. The annuloplasty ring of claim 10, wherein the ring body is “

downsized”

by reducing the major axis dimension by between about 1.0-1.5 mm relative to the corresponding transverse dimension of the annulus.

13. The annuloplasty ring of claim 10, wherein the ratio of the minor axis dimension to the major axis dimension is less than 3:

4.

14. The annuloplasty ring of claim 13, wherein the ratio of the minor axis dimension to the major axis dimension is less than or equal to 2.5:

4.

15. The annuloplasty ring of claim 10, wherein the ring body comprises a metal.

16. The annuloplasty ring of claim 15, wherein the metal is titanium.

17. The annuloplasty ring of claim 10, wherein the ring body comprises concentric metal bands.

18. The annuloplasty ring of claim 10, wherein the sewing cuff around the ring body has an enlarged portion around the periphery of the ring body that can accommodate two radially adjacent rows of suture lines.

19. The annuloplasty ring of claim 18, further including markings provided on the sewing cuff to indicate placement of the two radially adjacent rows of suture lines.

20. A method of performing annuloplasty of a mitral valve having valve leaflets comprising:

determining the approximate transverse dimension of the mitral valve annulus;

selecting for implantation to the mitral valve annulus a mitral valve annuloplasty ring, said ring 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

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

b) a ratio of the minor axis dimension to the major axis dimension is smaller than the ratio of an anterior-posterior dimension to the transverse dimension of the mitral valve annulus, and

implanting said ring so as to constrict the native annulus and restore the coaptation between the leaflets without reducing excessively the overall orifice area of the annuloplasty ring.