Anchoring device and method for replacing or repairing a heart valve

• US 10,238,489 B2
• Filed: 04/07/2017
• Issued: 03/26/2019
• Est. Priority Date: 12/21/2011
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Conklin, Brian S.
• Primary Examiner(s): Baria, Dinah
• Application Number:
  US15/482,529
• Publication Number:
  US 20170209269A1
• Time in Patent Office: 718 Days
• 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 method and 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 prosthetic implant intended for implantation at a native heart valve annulus, the anchoring device being formed of a biocompatible material and comprising:

two ring portions each having an associated anchor extending therefrom, the ring portions each being planar and rotatable with respect to each other, each of the anchors having a proximal fixed end secured to an associated ring portion and terminating in a distal free end not connected to the associated ring portion, wherein each of the anchors is spaced slightly away from and runs in a continuous, unbroken fashion substantially parallel to a circumference of the associated ring portion so as to form a valve leaflet-receiving slot between the anchor and the associated ring portion.

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

3. The anchoring device of claim 1, wherein the anchors extend in the same angular direction to each other.

4. The anchoring device of claim 1, further comprising one or more radiopaque markers positioned at the distal free ends of each anchor.

5. The anchoring device of claim 1, wherein in an anchored configuration the proximal fixed ends of the anchors are spaced at least 90 degrees apart.

6. The anchoring device of claim 1, wherein in an anchored configuration the proximal fixed ends of the anchors are spaced at least about 120 degrees apart.

7. The anchoring device of claim 1, wherein the anchoring device has two anchors, one on each ring portion, and one anchor is longer than the other.

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

9. The anchoring device of claim 1, further comprising a cloth covering around each of the anchors.

10. The anchoring device of claim 1, wherein the prosthetic implant comprises a prosthetic heart valve having a support frame and a valve portion, wherein the anchoring device is secured to the support frame.

11. The anchoring device of claim 1, wherein each anchor lies in the same plane as and radially outward from the associated ring portion.

12. The anchoring device of claim 1, wherein each anchor lies in a different plane than and axially spaced from the associated ring portion.

13. The anchoring device of claim 1, further comprising a cloth covering around the entire anchoring device.

14. The anchoring device of claim 13, further comprising a lubricious coating held by the cloth covering.

15. The anchoring device of claim 1, further comprising a bioresorbable covering around the entire anchoring device.

16. A method of implanting a prosthetic implant at a native valve annulus having resident valve leaflets, comprising:

providing a prosthetic implant comprising the anchoring device of claim 1;

positioning the anchoring device with the anchors adjacent the native valve annulus, with a fluid flow axis of the prosthetic implant generally parallel to a fluid flow path through the native valve annulus; and

independently rotating each of the ring portions to advance the distal free ends of each anchor underneath a resident valve leaflet thereby slidingly advancing the resident valve leaflets into the leaflet-receiving slots.

17. The method of claim 16, wherein the prosthetic implant comprises a prosthetic heart valve having 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, and, wherein the anchoring device is secured to the support frame.

18. The method of claim 16, wherein each anchor lies in the same plane as and radially outward from the associated ring portion.

19. The method of claim 16, wherein each anchor lies in a different plane than and axially spaced from the associated ring portion.

20. The method of claim 16, wherein in an anchored configuration the proximal fixed ends of the anchors are spaced at least about 120 degrees apart.

21. The method of claim 16, wherein the anchoring device has two anchors, one on each ring portion, and one anchor is longer than the other.

22. The method of claim 16, further comprising a cloth covering around each of the anchors.