Annuloplasty ring for mitral valve prolapse

• US 20060129236A1
• Filed: 02/02/2006
• Published: 06/15/2006
• Est. Priority Date: 04/29/2004
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: McCarthy, Patrick M.
• Granted Patent: US 7,951,196 B2
• Time in Patent Office: Days
• US Class Current: 623/2.360
• CPC Class Codes: A61F 2/2445 Annuloplasty rings in direct contact with the valve annulus
• CPC Class Codes: A61F 2/2448 D-shaped rings

Abstract

A mitral annuloplasty ring that has an outward and an upward posterior bow. The ring defines a closed, modified oval shape with a minor-major axis dimension ratio of between about 3.3:4 to 4:4. The ring is made of a material that will substantially resist distortion when subjected to the stress imparted thereon after implantation in the mitral valve annulus of an operating human heart. The outward and upward posterior bow of the annuloplasty ring corrects for pathologies associated with mitral valve prolapse, as seen with Barlow'"'"'s syndrome for instance, in which the leaflets tend to be elongated or floppy. Desirably, the outward bow includes a more pronounced outward bulge having an angular extent that approximately equals the angular extent of the upward bow. Sections adjacent the outward bulge may be relatively straight.

Claims

1. A mitral annuloplasty ring comprising a ring body arranged around a flow axis having an upward direction and a downward direction, the downward direction corresponding to the direction of blood flow through the mitral valve annulus when the annuloplasty ring is implanted, the ring body comprising:

an anterior segment generally defined between two trigones and adapted to be implanted against the anterior aspect of the mitral annulus;

a posterior portion opposite the anterior segment adapted to be implanted against the posterior aspect of the mitral annulus, and

wherein the ring body defines a modified D-shape in atrial plan view with the anterior segment defining a relatively straight side as compared with the posterior portion, and with a minor axis extending between and bisecting the anterior segment and posterior portion and a major axis extending perpendicularly thereto, the major and minor axes being generally perpendicular to the flow axis, and wherein the posterior portion of the ring body has an outward bow more pronounced than adjacent sections and an upward bow from adjacent sections that has an axial height h of between about 3-10 mm.

2. The mitral annuloplasty ring of claim 1, wherein the ring body is saddle-shaped such that the anterior segment also defines an upward bow from adjacent sections.

3. The mitral annuloplasty ring of claim 1, wherein the outward bow has an angular extent of between 90-130°

.

4. The mitral annuloplasty ring of claim 3, further including an outward bulge in the outward bow of the posterior portion that has a smaller radius of curvature than adjacent sections and spans an angular extent of between about 80-90°

.

5. The mitral annuloplasty ring of claim 4, wherein the upward bow in the posterior portion has an angular extent approximately equal to the outward bulge.

6. A method of correcting mitral valve prolapse wherein a posterior leaflet of the mitral valve is causing mitral regurgitation, comprising:

providing an annuloplasty ring having;

a rounded ring body arranged in atrial plan view around a 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 when the annuloplasty ring is implanted;

an anterior segment extending between two trigones and adapted to be implanted against the anterior aspect of the mitral annulus;

a posterior portion opposite the anterior segment adapted to be implanted against the posterior aspect of the mitral annulus, wherein the posterior portion defines an outward and an upward bow relative to adjacent sections of the ring; and

a suture-permeable exterior on the ring body for securing the annuloplasty ring to the mitral annulus;

delivering the annuloplasty ring to the mitral annulus; and

securing the annuloplasty ring to the mitral annulus using the suture-permeable exterior such that the posterior portion pulls the periphery of the posterior leaflet of the mitral valve outward and upward and reduces the mitral regurgitation.

7. The method of claim 6, wherein the ring body defines a modified D-shape in atrial plan view with the anterior segment defining a relatively straight side as compared with the posterior portion, and with a minor axis extending between and bisecting the anterior segment and posterior portion and a major axis extending perpendicularly thereto, the major and minor axes being generally perpendicular to the flow axis, and wherein the outward bow of the posterior portion creates a minor axis to major axis dimension ratio of between about 3.3:

4 (82.5%) and 4;

4 (100%).

8. The method of claim 7, wherein an axial height h of the upward bow of the posterior portion is between about 11%-28% of the major axis dimension.

9. The method of claim 6, wherein an axial height h of the upward bow of the posterior portion is between about 3-10 mm.

10. A mitral annuloplasty ring comprising a ring body arranged around a flow axis having an upward direction and a downward direction, the downward direction corresponding to the direction of blood flow through the mitral valve annulus when the annuloplasty ring is implanted, the ring body comprising:

an anterior segment generally defined between two trigones and adapted to be implanted against the anterior aspect of the mitral annulus;

a posterior portion opposite the anterior segment adapted to be implanted against the posterior aspect of the mitral annulus, and

wherein the ring body defines a modified D-shape in atrial plan view with the anterior segment defining a relatively straight side as compared with the posterior portion, and with a minor axis extending between and bisecting the anterior segment and posterior portion and a major axis extending perpendicularly thereto, the major and minor axes being generally perpendicular to the flow axis, and wherein the posterior portion of the ring body has an outward bow that creates a minor axis to major axis dimension ratio of between about 3.3;

4 (82.5%) and 4;

4 (100%).

11. The mitral annuloplasty ring of claim 10, wherein the ring body further includes an upward bow in the posterior portion.

12. The mitral annuloplasty ring of claim 11, wherein an axial height h of the upward bow is between about 11%-28% of the major axis dimension.

13. The mitral annuloplasty ring of claim 12, wherein the axial height h of the upward bow is between about 3-10 mm.

14. The mitral annuloplasty ring of claim 10, wherein the outward bow has an angular extent of between 90-130°

.

15. The mitral annuloplasty ring of claim 10, wherein the minor axis to major axis dimension ratio is between about 3.44:

4 (86%) and 3.6;

4 (90%).

16. The mitral annuloplasty ring of claim 10, further including an outward bulge in the outward bow of the posterior portion that has a smaller radius of curvature than adjacent sections.

17. The mitral annuloplasty ring of claim 16, wherein the sections adjacent the outward bulge are relatively straight.

18. The mitral annuloplasty ring of claim 16, wherein the ring body further includes an upward bow in the posterior portion that has an angular extent approximately equal to the outward bulge.

19. The mitral annuloplasty ring of claim 18, wherein the outward bow spans an angular extent of between about 90-130°

, and the outward bulge spans an angular extent of between about 80-90°

.

20. The mitral annuloplasty ring of claim 10, wherein the ring body defines a continuous, closed periphery.