IP Library › Granted Patent US 10,820,996
Granted Patent B2
US 10,820,996 · App. 16/273,065 · Granted Nov 3, 2020

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

Inventor: Hanson Gifford, III (Woodside, CA)
Assignee: Twelve, Inc.
A61F2/246A61F2/2445A61F2/2454A61F2/2463A61F2/2466A61F2/2412A61F2/2487A61F2210/0014A61F2210/0061A61F2210/0085A61F2230/0004A61F2250/0003A61F2250/0063A61F2250/0069
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Quick Facts
Patent No.
US 10,820,996
App. No.
16/273,065
Granted
Nov 3, 2020
Kind
B2
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 (33)

1. 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, the repair device comprising:

a support having (a) a contracted configuration in which the support is sized to be inserted under the posterior leaflet between a wall of the left ventricle and chordae tendineae and (b) an extended configuration in which the support projects 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 sufficiently to improve coaptation of the posterior and anterior leaflets, wherein the support comprises a plurality of projections and a plurality of depressions, each depression being disposed between two of the projections, and wherein the plurality of projections and the plurality of depressions are configured to, when the support is in the extended configuration, engage chordae tendineae attached to the posterior leaflet; and

an appendage configured to, when the support is in the extended configuration, extend beyond an edge of the posterior leaflet toward the anterior leaflet.

2. The repair device of claim 1 , wherein the support comprises an extension unit configured to push at least a portion of the posterior leaflet towards the anterior leaflet of the native mitral valve, and wherein the extension unit is expandable from the contracted configuration to the extended configuration.

3. The repair device of claim 2 , wherein the extension unit comprises an inflatable or fillable member.

4. The repair device of claim 3 , further comprising a port in communication with the inflatable or fillable member for delivering a fluid thereto.

5. The repair device of claim 2 , wherein the support comprises an elongated spine, the extension unit being coupled to the spine.

6. The repair device of claim 5 , wherein the extension unit is substantially more flexible than the spine in the contracted configuration.

7. The repair device of claim 5 , wherein the spine has a longitudinal axis and the extension unit is configured to expand in a direction transverse to the longitudinal axis.

8. The repair device of claim 5 , wherein the spine is curved in an unconstrained state and the extension unit is configured to expand in a radial direction relative to the spine.

9. The repair device of claim 2 , wherein the extension unit comprises a flexible cover extending around the spine.

10. The repair device of claim 9 , wherein the flexible cover is inflatable or fillable with a fluid.

11. The repair device of claim 2 , wherein the extension unit is substantially more rigid in the expanded configuration.

12. The repair device of claim 2 , wherein the extension unit is preformed to include the plurality of projections when in the extended configuration.

13. The repair device of claim 2 , wherein the extension unit includes at least one bladder configured to receive filler material, and wherein the extension unit is expandable with the filler material to form the plurality of projections when the extension unit is in the extended configuration.

14. The repair device of claim 1 , wherein the support is configured to be held in the subannular position without penetrating the posterior leaflet or heart wall tissue.

15. The repair device of claim 1 , wherein the support is configured to reside substantially entirely on the subannular side of the posterior leaflet.

16. The repair device of claim 1 , wherein the support is configured to allow the posterior leaflet to move between a partially closed position and a completely closed position during a cardiac cycle.

17. The repair device of claim 1 , wherein the support maintains the posterior leaflet of the native mitral valve in a partially closed position so as to sealingly engage the anterior leaflet of the native mitral valve during a portion of a cardiac cycle.

18. The repair device of claim 1 , wherein the repair device has a triangular or polygonal cross-section.

19. The repair device of claim 1 , wherein the support comprises a spine and an extension unit coupled to the spine, and wherein:

the extension unit is expandable from the contracted configuration to the extended configuration;

the extension unit includes the plurality of projections and depressions; and

the projections expand between and engage chordae tendineae attached to the posterior leaflet.

20. The repair device of claim 1 , wherein the support expands to form a “C” shape to conform to a portion of the native mitral valve.

21. 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, the repair device comprising:

a support having (a) a contracted configuration in which the support is sized to be inserted under the posterior leaflet between a wall of the left ventricle and chordae tendineae and (b) an extended configuration in which the support projects 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 sufficiently to improve coaptation of the posterior and anterior leaflets, wherein the support comprises:

an extension unit configured to push at least a portion of the posterior leaflet towards the anterior leaflet of the native mitral valve, and wherein the extension unit is expandable from the contracted configuration to the extended configuration; and

an elongated spine coupled to the extension unit; and

an appendage configured to, when the support is in the extended configuration, extend beyond an edge of the posterior leaflet toward the anterior leaflet.

22. The repair device of claim 21 , wherein the extension unit is substantially more flexible than the spine in the contracted configuration.

23. The repair device of claim 21 , wherein the spine has a longitudinal axis and the extension unit is configured to expand in a direction transverse to the longitudinal axis.

24. The repair device of claim 21 , wherein the spine is curved in an unconstrained state and the extension unit is configured to expand in a radial direction relative to the spine.

Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded May 15, 2019
From: GIFFORD, HANSON, III
To: TWELVE, INC.
Reel/Frame 049183/0493 →
Continuity (3)
Continuation 15241155 · Aug 19, 2016
Provisional Application 62208458 · Aug 21, 2015
Related Publication 20190167427A1 · Jun 6, 2019
Cited By (1)
US 12,336,906