Methods for anchoring a device at a native heart valve annulus

• US 9,737,401 B2
• Filed: 07/12/2015
• Issued: 08/22/2017
• 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): Isabella, David
• Assistant Examiner(s): BARIA, DINAH N
• Application Number:
  US14/797,163
• Publication Number:
  US 20160367365A1
• Time in Patent Office: 772 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. A method of implanting a device at a native valve annulus, comprising:

providing a device comprising a central portion defining a periphery centered around a flow orifice with a fluid flow axis therethrough, a first curved anchor extending from a first fixed end secured to the central portion and being spaced away from and passing generally parallel to the periphery to a first free end so as to form a first leaflet-receiving slot, a second curved anchor extending from a second fixed end secured to the central portion and being spaced away from and passing generally parallel to the periphery to a second free end so as to form a second leaflet-receiving slot, the first and second curved anchors not overlapping one another, wherein the first and second curved anchors lie in the same plane as and radially outward from the central portion;

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 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 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.

2. The method of claim 1, wherein the resident valve annulus is a native mitral valve annulus, the first commissure is an anterior commissure of a native mitral valve, the first leaflet is a posterior leaflet of the native mitral valve;

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

3. The method of claim 2, wherein the fixed ends of the first and second curved anchors are spaced 120 degrees apart, and the first curved anchor is longer than the second curved anchor.

4. The method of claim 1, 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.

5. The method of claim 1, wherein the device comprises an annuloplasty ring, with the central portion forming a ring portion of the annuloplasty ring.

6. The method of claim 1, wherein each first and second curved anchor terminates in a rounded, enlarged end.

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

providing a device comprising a central portion defining a periphery centered around a flow orifice with a fluid flow axis therethrough, a first curved anchor extending from a first fixed end secured to the central portion and being spaced away from and passing generally parallel to the periphery to a first free end so as to form a first leaflet-receiving slot, a second curved anchor extending from a second fixed end secured to the central portion and being spaced away from and passing generally parallel to the periphery to a second free end so as to form a second leaflet-receiving slot, the first and second curved anchors not overlapping one another, wherein the first and second curved anchors lie in the same plane as and radially outward from the central portion;

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;

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

rotating the device 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;

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

rotating the device 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; and

stopping rotation of the device when the first and second resident valve leaflets are slidingly advanced respectively, into the first and second leaflet-receiving slots.

8. The method of claim 7, wherein the fixed ends of the first and second curved anchors are spaced at least 90 degrees apart.

9. The method of claim 8, wherein the fixed ends of the first and second curved anchors are spaced 120 degrees apart, and the first curved anchor is longer than the second curved anchor.

10. The method of claim 7, wherein one of the first and second curved anchors is longer than the other.

11. The method of claim 10, wherein the first anchor extends around the periphery of the central portion through an angle of at least 90 degrees while the second anchor extends around the periphery of the central portion through an angle of at least 120 degrees.

12. The method of claim 7, 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.

13. The method of claim 7, wherein the device comprises an annuloplasty ring, with the central portion forming a ring portion of the annuloplasty ring.

14. The method of claim 7, wherein each anchor terminates in a rounded, enlarged end.

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

providing a device comprising a central ring defining a periphery centered around a flow orifice with a fluid flow axis therethrough, the device having a plurality of anchors each having a proximal end fixed to the central ring and a distal end not connected to the central ring, each anchor extending in a continuous, unbroken fashion from the proximal end to the distal end substantially parallel to and spaced from the curved circumference of the central ring to form leaflet-receiving slots, and each anchor extending from a different angular position around the central ring and extending in the same angular direction, wherein the distal ends of each anchor terminate at different locations around the central ring the plurality of anchors being non-overlapping 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;

positioning the device with a first anchor and a second 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

rotating the device about the fluid flow axis thereof to advance the distal ends of the first and second anchors underneath resident valve leaflets and thereby slidingly advancing the resident valve leaflets into the leaflet-receiving slots.

16. The method of claim 15, wherein each anchor terminates in a rounded, enlarged end.

17. The method of claim 16, wherein the first and second anchors lie in the same plane as and radially outward from the central ring.

18. The method of claim 15, wherein the first and second anchors lie in the same plane as and radially outward from the central ring.

19. The method of claim 15, wherein the first and second anchors lie in a different plane than and axially spaced from the central ring.

20. The method of claim 15, wherein one of the anchors is longer than the other.

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

providing a device comprising a central portion defining a periphery centered around a flow orifice with a fluid flow axis therethrough, a first curved anchor extending from a first fixed end secured to the central portion and being spaced away from and passing generally parallel to the periphery to a first free end so as to form a first leaflet-receiving slot, a second curved anchor extending from a second fixed end secured to the central portion and being spaced away from and passing generally parallel to the periphery to a second free end so as to form a second leaflet-receiving slot, the first and second curved anchors not overlapping one another, wherein the device has three anchors that are spaced 120 degrees apart;

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;

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

rotating the device 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;

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

rotating the device 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; and

stopping rotation of the device when the first and second resident valve leaflets are slidingly advanced respectively, into the first and second leaflet-receiving slots.

22. The method of claim 21, 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.

23. The method of claim 21, wherein the anchors lie in a different plane than and axially spaced from the central portion.