Annuloplasty device having shape-adjusting tension filaments

• US 20070083259A1
• Filed: 10/11/2005
• Published: 04/12/2007
• Est. Priority Date: 10/11/2005
• Status: Active Grant

• Current Assignee: Medtronic Vascular, Inc. (Medtronic Plc)
• Original Assignee: Medtronic Vascular, Inc. (Medtronic Plc)
• Inventors: Rafiee, Nasser, Bloom, Eliot
• Granted Patent: US 7,695,510 B2
• Time in Patent Office: Days
• US Class Current: 623/2.110
• CPC Class Codes: A61F 2/2445 Annuloplasty rings in direct contact with the valve annulus
• CPC Class Codes: A61F 2/2454 Means for preventing inversion of the valve leaflets, e.g. chordae tendineae prostheses

Abstract

A system for treating mitral valve regurgitation includes a tensioning device having a flexible annuloplasty ring, a plurality of anchoring members and a tensioning filament attached to the flexible ring. One embodiment of the invention includes a method for attaching a flexible annuloplasty ring to the annulus of a mitral valve, and adjusting the lengths of segments of the tension filament attached to the flexible ring in order to exert force vectors on the annulus, thereby reshaping the mitral valve annulus so that the anterior and posterior leaflets of the mitral valve close completely during ventricular contraction.

Claims

1. A system for treating mitral valve regurgitation comprising:

a catheter;

a tensioning device received in a lumen of the catheter, the tensioning device including a flexible ring,

a plurality of anchoring members disposed about the flexible ring, and

a tensioning filament attached to the flexible ring;

wherein when the system is delivered proximate a mitral valve, the tensioning device is deployed, the anchoring members are fixed to an annulus of the mitral valve and the tensioning filament is adjusted to change the shape of the annulus.

2. The system of claim 1 wherein in the flexible ring has a D-shaped planar configuration and an elongated configuration.

3. The system of claim 1 wherein the anchoring members comprise barbs positioned at an angle to the plane of the flexible ring.

4. The system of claim 3 wherein the barbs embed into the mitral valve annulus and maintain the flexible ring in a supra-annular position adjacent to the mitral valve annulus.

5. The system of claim 3 further comprising a plurality of cleats disposed about the flexible ring wherein each cleat is paired with a barb and each cleat/barb pair is located at the same planar point on the flexible ring.

6. The system of claim 5 wherein the tensioning filament is slidably attached to each cleat.

7. The system of claim 6 wherein the tensioning filament is attached to each cleat using a double counter bored hole.

8. The system of claim 6 wherein, when the tensioning filament is adjusted at each cleat, force vectors are exerted on the mitral valve annulus and cause the shape of the mitral valve annulus to change.

9. The system of claim 1 wherein the delivery catheter comprises:

an outer sheath;

a delivery chamber within the sheath at a distal end of the catheter; and

a deployment device positioned within the sheath, wherein when the system is delivered adjacent to a mitral valve, the flexible ring is deployed from the delivery chamber and positioned adjacent to the annulus of the mitral valve.

10. The system of claim 9 further comprising an inflatable balloon at the distal tip of the catheter wherein, when the balloon is inflated, the flexible ring is seated against the annulus of the mitral valve.

11. A method of treating mitral valve regurgitation, the method comprising:

providing a tensioning device including a flexible ring, a plurality of anchoring members disposed about the flexible ring, and a tensioning filament attached to the flexible ring;

preloading the tensioning device into a lumen of a catheter;

deploying the tensioning device from the catheter adjacent to a mitral valve;

positioning the flexible ring against an annulus of the mitral valve;

embedding the anchoring members into the annulus;

adjusting a length of segments of the tensioning filament;

altering a shape of the flexible ring responsive to the adjustment of the segments of the length of the tensioning filament; and

reshaping the annulus in response to altering the shape of the flexible ring.

12. The method of claim 11 furthering comprising adjusting the tensioning filament so that force vectors are exerted on the mitral valve annulus and the shape of the mitral annulus is changed.

13. The method of claim 11 wherein reshaping the valve annulus reduces mitral valve regurgitation.

14. A tensioning device for treating mitral valve regurgitation comprising:

a flexible ring, a plurality of anchoring members disposed about the flexible ring, and a tensioning filament attached to the flexible ring;

wherein when the tensioning device is preloaded into a catheter, and delivered proximate the mitral valve, the tensioning device is deployed, the anchoring members are embedded into an annulus of the mitral valve and the tensioning filament is adjusted, the shape of the annulus is changed.

15. The device of claim 14 wherein the flexible ring has a D-shaped planar configuration and a constrained configuration.

16. The device of claim 14 wherein the anchoring members are barbs positioned between 10 and 45 degrees to the plane of the flexible ring.

17. The device of claim 16 further comprising a series of cleats disposed about the flexible ring wherein each cleat is paired with a barb and each cleat/barb pair is located at the same planar point on the flexible ring.

18. The device of claim 17 wherein the tensioning filament is slidably attached to each cleat.

19. The device of claim 18 wherein when the tensioning filament is adjusted at each cleat, force vectors are exerted on the mitral annulus and cause the shape of the mitral annulus to change.

20. The device of claim 17 wherein the tensioning filament is attached to each cleat using at least one hole through the cleat.