ANCHORING DEVICE AND METHOD FOR REPLACING OR REPAIRING A HEART VALVE

• US 20130166022A1
• Filed: 11/13/2012
• Published: 06/27/2013
• Est. Priority Date: 12/21/2011
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Conklin, Brian S.
• Granted Patent: US 9,078,747 B2
• Time in Patent Office: Days
• US Class Current: 623/2.17
• CPC Class Codes: A61F 2/02 Prostheses implantable into the body closure means for urethra or rectum or for artificial body openings therefor A61F2/0004
• CPC Class Codes: A61F 2/2409 Support rings therefor, e.g. for connecting valves to tissue annuloplasty rings A61F2/2442
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2442 Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
• CPC Class Codes: A61F 2/2445 Annuloplasty rings in direct contact with the valve annulus
• CPC Class Codes: A61F 2/2457 Chordae tendineae prostheses
• CPC Class Codes: A61F 2/2463 Implants forming part of the valve leaflets
• CPC Class Codes: A61F 2220/0008 Fixation appliances for connecting prostheses to the body
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2230/0069 cylindrical
• CPC Class Codes: A61F 2250/0018 differing in elasticity, stiffness or compressibility

Abstract

A device for anchoring a prosthetic heart valve or annuloplasty ring to a valve annulus in a heart and a method of implanting same is disclosed. The device can include a prosthetic valve or annuloplasty ring with one or more anchors configured to be threaded or otherwise passed underneath a native leaflet and/or subvalvular tissue to secure the device at the native annulus.

Claims

1. An anchoring device for a device intended for implantation at a native heart valve annulus, said anchoring device comprising:

a central portion with one or more anchors extending therefrom, each of said one or more anchors having a proximal fixed end secured to the central portion and terminating in free end, said one or more anchors being spaced slightly away from and running substantially parallel to the circumference of the central portion in a curved fashion, forming valve leaflet-receiving slots between the anchors and the central portion.

2. The anchoring device of claim 1, wherein the anchors include a cross-section configured to have a different stiffness in-plane than the stiffness out-of-plane.

3. The anchoring device of claim 1, wherein the anchors are generally equidistantly positioned around the circumference central portion of the anchoring device.

4. The anchoring device of claim 1, wherein the anchors are formed of metal or polymer.

5. The anchoring device of claim 1, further comprising one or more radiopaque markers positioned thereon.

6. The anchoring device of claim 1, wherein the device has two anchors and the fixed ends of the anchors are spaced at least 90 degrees apart.

7. The anchoring device of claim 1, wherein the device has two anchors and the fixed ends of the anchors are spaced about 120 degrees apart.

8. The anchoring device of claim 1, wherein the device has two anchors, one of which is longer than the other.

9. The anchoring device of claim 1, wherein the device has three anchors.

10. The anchoring device of claim 1, wherein the slots have a length of about 0.25 to 3.5 inches.

11. The anchoring device of claim 1, further comprising a cloth covering.

12. The anchoring device of claim 1, wherein the central portion is substantially circular.

13. The anchoring device of claim 1, wherein the central portion is generally D-shaped.

14. The anchoring device of claim 1, further comprising a prosthetic valve comprising a support frame and a valve portion, wherein the anchoring device is secured to the support frame of the prosthetic valve.

15. The anchoring device of claim 14, wherein at least a portion of the prosthetic valve is substantially tubular and has an exterior surface forming a continuously curved surface, and said one or more anchors form a curve which parallels the curved surface of the exterior surface of the prosthetic valve.

16. The anchoring device of claim 1, further comprising an annuloplasty ring, wherein the anchoring device is secured to the ring such that the one or more anchors extend at least partially around a circumference of the ring and substantially parallel to an outer surface of the ring.

17. A method of implanting a device at a native valve annulus, comprising:

providing a device comprising a central portion, a first curved anchor extending from a first fixed end secured to the central portion and passing generally parallel to an outer surface thereof to a first free end of the first curved anchor to form a first leaflet-receiving slot, a second curved anchor extending from a second fixed end secured to the central portion and passing generally parallel to an outer surface thereof to a second free end to form a second leaflet-receiving slot, wherein the central portion defines a flow orifice with a fluid flow axis therethrough;

positioning the device with the first curved anchor and second curved anchor adjacent the native valve annulus, with the fluid flow axis of the device generally parallel to a fluid flow path through the native valve annulus, and with the first free end positioned adjacent a first commissure of a resident heart valve at the native valve annulus;

placing the first free end underneath a first resident valve leaflet;

rotating the device substantially about the fluid flow axis thereof to advance the first free end underneath the first resident valve leaflet and thereby slidingly advancing the first resident valve leaflet into the first leaflet-receiving slot;

monitoring the position of the second free end with respect to a second commissure of the resident heart valve;

stopping rotation of the device about the fluid flow axis once the second free end is adjacent the second commissure of the resident heart valve;

placing the second free end underneath a second resident valve leaflet;

recommencing rotating the device substantially about the fluid flow axis thereof to advance the second free end underneath the second resident valve leaflet and thereby slidingly advancing the second resident valve leaflet into the second leaflet-receiving slot while also further advancing the first free end underneath the first resident valve leaflet and further slidingly advancing the first resident valve leaflet into the first leaflet-receiving slot; and

stopping rotation of the device when the first resident valve leaflet is slidingly advanced into the first leaflet-receiving slot at a position adjacent the first fixed end, whereby deployment of the device is completed.

18. The method of claim 17, wherein the device comprises a prosthetic valve, wherein the prosthetic valve comprises a support frame and leaflets with the leaflets secured to the support frame to form a one-way valve structure controlling fluid flow along the flow axis.

19. The method of claim 17, wherein the resident valve annulus is a native mitral valve annulus, the first commissure is a PC commissure of a native mitral valve, the first leaflet is an anterior leaflet of the native mitral valve;

the second commissure is an AC commissure of the native mitral valve, and the second leaflet is a posterior leaflet of the native mitral valve.

20. The method of claim 17, wherein the device comprises an annuloplasty ring, with the central portion forming the ring portion of the annuloplasty ring.