Implant heart valve devices, mitral valve repair devices and associated systems and methods

• US 10,238,490 B2
• Filed: 08/19/2016
• Issued: 03/26/2019
• Est. Priority Date: 08/21/2015
• Status: Active Grant

• Current Assignee: Twelve, Inc. (Medtronic Plc)
• Original Assignee: Twelve, Inc. (Medtronic Plc)
• Inventors: Gifford, III, Hanson
• Primary Examiner(s): Sharma, Yashita
• Assistant Examiner(s): Preston, Rebecca S
• Application Number:
  US15/241,155
• Publication Number:
  US 20170049571A1
• Time in Patent Office: 949 Days
• CPC Class Codes: A61F 2/2412 with soft flexible valve members, e.g. tissue valves shaped like natural valves check valves with flexible valve members in general F16K15/14
• 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
• CPC Class Codes: A61F 2/246 Devices for obstructing a leak through a native valve in a closed condition
• CPC Class Codes: A61F 2/2463 Implants forming part of the valve leaflets
• CPC Class Codes: A61F 2/2466 Delivery devices therefor
• CPC Class Codes: A61F 2/2487 Devices within the heart chamber, e.g. splints
• CPC Class Codes: A61F 2210/0014 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2210/0061 swellable
• CPC Class Codes: A61F 2210/0085 hardenable in situ, e.g. epoxy resins
• CPC Class Codes: A61F 2230/0004 Rounded shapes, e.g. with rounded corners
• CPC Class Codes: A61F 2250/0003 having an inflatable pocket filled with fluid, e.g. liquid or gas
• CPC Class Codes: A61F 2250/0063 Nested prosthetic parts
• CPC Class Codes: A61F 2250/0069 Sealing means

Abstract

Systems, devices and methods for repairing a native heart valve. In one embodiment, a repair device for repairing a native mitral valve having an anterior leaflet and a posterior leaflet between a left atrium and a left ventricle comprises a support having a contracted configuration and an extended configuration, and an appendage, such as a flap or apron extending from the support. In the contracted configuration, the support is sized to be inserted under the posterior leaflet between a wall of the left ventricle and chordae tendineae. In the extended configuration, the support is configured to project anteriorly with respect to a posterior wall of the left ventricle by a distance sufficient to position at least a portion of the posterior leaflet toward the anterior leaflet, and the appendage is configured to extend beyond an edge of the posterior leaflet toward the anterior leaflet.

Claims

1. A method of repairing a native mitral valve having an anterior leaflet and a posterior leaflet between a left atrium and a left ventricle, comprising:

positioning a repair device in the left ventricle under the posterior leaflet and between a wall of the left ventricle and chordae tendineae; and

engaging an underside of the posterior leaflet with a support of the repair device such that a portion of the posterior leaflet moves toward the anterior leaflet,

wherein, in the engaged arrangement, the repair device further includes a flap extending beyond an edge of the posterior leaflet toward the anterior leaflet.

2. A method for repairing a native valve of a patient, the method comprising:

positioning a heart valve repair device in a subannular position behind at least one leaflet connected to chordae tendineae, the repair device having a support in an unexpanded configuration; and

expanding the support in the subannular position such that the support engages an interior surface of a heart wall and a downstream-facing surface of the at least one leaflet,

wherein the repair device is configured to reposition the at least one leaflet into an at least partially closed position and brace the at least one leaflet such that the function of the native valve is improved,

wherein, in the expanded arrangement, the repair device further includes an appendage extending beyond an edge of the at least one leaflet toward another adjacent leaflet.

3. The method of claim 2 wherein the native valve is a mitral valve, and wherein the heart wall is a left ventricular wall and the at least one leaflet is a posterior mitral valve leaflet.

4. The method of claim 2 wherein prior to positioning the heart valve repair device the patient has mitral valve regurgitation, and wherein the repair device reduces the regurgitation after expanding the support in the subannular position.

5. The method of claim 2 wherein the support comprises an extension unit configured to expand along the downstream-facing surface of the at least one leaflet.

6. The method of claim 5 wherein the extension unit is configured to expand in a direction toward the edge of the at least one leaflet.

7. The method of claim 5 wherein tissue grows into the extension unit after the repair device braces the at least one leaflet in the at least partially closed position.

8. The method of claim 5 wherein the extension unit comprises a plurality of projections configured to extend between the chordae tendineae connected to the at least one leaflet.

9. The method of claim 5, further comprising injecting a filler material into the extension unit.

10. The method of claim 9 wherein the extension unit comprises a plurality of projections configured to extend between the chordae tendineae connected to the at least one leaflet and wherein the filler material fills and expands the plurality of projections so as to extend between the chordae tendineae.

11. The method of claim 2 wherein after expanding, the support is held in place by chordae tendineae attached to the at least one leaflet.

12. The method of claim 11 wherein the support is retained between the chordae tendineae and the at least one leaflet and the heart wall.

13. The method of claim 2 wherein the repair device is held in place without penetrating the at least one leaflet or heart wall tissue.

14. A method of repairing a native mitral valve having anterior leaflet and a posterior leaflet between a left atrium and a left ventricle, comprising

implanting a repair device having a support and an appendage under the posterior leaflet, wherein

the support comprises an extension unit, and

implanting the repair device under the posterior leaflet comprises implanting the extension unit under the posterior leaflet in an unexpanded state;

and

causing the support to press against a portion of an underside of the posterior leaflet and thereby push at least a portion of the posterior leaflet toward the anterior leaflet and extend the appendage beyond an edge of the posterior leaflet toward the anterior leaflet wherein causing the support to press against the underside of the posterior leaflet or engaging the underside of the posterior leaflet with the support comprises extending at least a portion of the extension unit such that the support presses against a wider portion of the posterior leaflet than in the unexpanded state.

15. The method of claim 14 wherein the extension unit comprises an inflatable bladder and extending the at least a portion of the extension unit comprises injecting an inflation medium into the inflatable bladder.

16. The method of claim 15 wherein the inflation medium comprises a biocompatible fluid.

17. The method of claim 15 wherein the inflation medium comprises a curable fluid that is injected into the inflatable bladder in a fluidic state and then cures to a hardened state.

18. The method of claim 14 wherein the extension unit comprises a self-expanding metal structure and the extending at least a portion of the extension unit comprises releasing the self-expanding metal structure from a collapsed state such that the self-expanding metal structure presses against the underside of the posterior leaflet.

19. A method of repairing a native mitral valve having an anterior leaflet and a posterior leaflet between a left atrium and a left ventricle, comprising:

implanting a repair device having a support and an appendage under the posterior leaflet, wherein the support comprises a plurality of projections and a plurality of depressions, each depression being disposed between two of the projections, and

causing the support to press against a portion of an underside of the posterior leaflet and thereby push at least a portion of the posterior leaflet toward the anterior leaflet and extend the appendage beyond an edge of the posterior leaflet toward the anterior leaflet, wherein causing the support to press against an underside of the posterior leaflet or engaging the underside of the posterior leaflet with the support comprises extending the projections along the underside of the posterior leaflet such that an upper side of the projections presses against the posterior leaflet and the chordae tendineae are positioned in at least some of the depressions.