Devices, systems and methods for heart valve replacement

Patent metadata

Field	Value
Publication number	US-9763780-B2
Application number	US-201214352964-A
Country	US
Kind code	B2
Filing date	Oct 19, 2012
Priority date	Oct 19, 2011
Publication date	Sep 19, 2017
Grant date	Sep 19, 2017

Abstract

A prosthetic heart valve device ( 100 ) for percutaneous replacement of a native heart valve includes an expandable retainer ( 110 ) at least partially surrounding and coupled to an inner valve support ( 120 ). The device can further include a prosthetic valve ( 130 ) coupled to the valve support. The retainer forms a donut-shaped flange ( 190 ) having an arcuate outer surface ( 142 ) for engaging tissue and an inner lumen defining a passage for blood to flow through the valve support. The retainer can include a plurality of circumferentially positioned, resiliency deformable and flexible ribs ( 114 ) which are coupled at their downstream ends 116 to the valve support 120 . The flexible ribs, in one embodiment, can have a general C-shape configuration with the tips ( 117 ) of the flexible ribs and an opening ( 119 ) of the C-shape configuration oriented toward a longitudinal axis ( 101 ) of the device.

First claim

We claim:

1. A device for repair or replacement of a native heart valve, the native heart valve having an annulus and native leaflets associated with the annulus, comprising:
a valve support having an inflow end and an outflow end extending along a longitudinal axis, the valve support having an outer surface and an inner surface, wherein the inner surface is configured to support a prosthetic valve, and wherein the valve support has a cross-sectional shape;
an expandable ring-shaped retainer positioned at the inflow end of the valve support, the retainer configured to engage and seal with tissue on or near the annulus on an inner or inflow side of the native leaflets;
wherein the inflow end of the valve support is radially inward from and longitudinally overlapping a portion of the retainer when the device is in a deployed configuration; and
wherein the valve support is mechanically isolated from the retainer such that the cross-sectional shape of the valve support remains substantially cylindrical such that the prosthetic valve remains competent when the retainer is deformed into a non-circular shape by engagement with the tissue.

2. The device of claim 1 wherein the retainer extends upstream and radially outward of the valve support.

3. The device of claim 1 wherein the retainer is configured to engage valve tissue selected from an inward-facing surface of the annulus and an inward facing surface of the leaflets downstream of the annulus.

4. The device of claim 1 wherein the device is moveable into a plurality of configurations including:
a first configuration in which the valve support and the retainer are radially contracted, and wherein the valve support has a first cross-sectional shape;
a second configuration in which the valve support and the retainer are radially expanded, and wherein the valve support has a second cross-sectional shape greater than the first cross-sectional shape; and
a third configuration in which the retainer is engaged with and at least partially deformed by tissue on or near the annulus while the valve support remains in the second cross-sectional shape.

5. The device of claim 4 wherein the retainer has an outer circumference, the outer circumference being generally circular in the second configuration and generally non-circular in the third configuration.

6. The device of claim 1 wherein at least a portion of the valve support is generally circular and the retainer is deformable to be generally non-circular when engaging the tissue.

7. The device of claim 1 wherein the valve support includes a plurality of posts connected circumferentially by a plurality of struts, and wherein the retainer includes a plurality of arcuate ribs extending outward from the valve support and in an upstream direction, the ribs being distributed about a perimeter of the valve support.

8. The device of claim 1 wherein the retainer includes a plurality of flexible ribs distributed around a perimeter of the valve support, and wherein one or more ribs bends or rotates in the deployed configuration.

9. The device of claim 1 , further comprising a plurality of arms coupled to the valve support and configured to engage an inward-facing surface of the leaflets downstream of the annulus.

10. The device of claim 9 wherein the arms include one or more tissue engaging elements for penetrating the inward-facing surface of the leaflets.

11. The device of claim 9 wherein the plurality of arms are configured to inhibit movement of the device toward an atrium by engagement of the annulus or the leaflets downstream of the annulus.

12. The device of claim 9 wherein the plurality of arms are moveable from an inward configuration for delivery of the device through vasculature of a patient to an outward configuration for engagement of the tissue on or near the annulus.

13. The device of claim 1 , further comprising a valve coupled to the valve support to inhibit retrograde blood flow.

14. The device of claim 13 wherein the valve is a tri-leaflet valve.

15. The device of claim 1 , further comprising a sealing membrane covering the expandable retainer.

16. The device of claim 1 , further comprising tissue engaging elements extending from the expandable retainer.

17. A device for repair or replacement of a native heart valve, the native heart valve having an annulus and native leaflets associated with the annulus, comprising:
a valve support having an inflow end and an outflow end extending along a longitudinal axis, the valve support having an outer surface and an inner surface, wherein the inner surface is configured to support a prosthetic valve, and wherein the valve support has a cross-sectional shape;
an expandable ring-shaped retainer coupled to the inflow end of the valve support, the retainer coupled to the inflow end of the valve support, the retainer configured to engage and seal with tissue on or near the annulus on an inner or inflow side of the native leaflets, wherein the retainer includes a plurality of flexible C-shaped ribs circumferentially positioned around an upper portion of the device, and wherein the retainer is a donut-shaped flange coupled to the inflow end of the valve support; and
wherein the valve support is mechanically isolated from the retainer such that the cross-sectional shape of the valve support remains substantially cylindrical such that the prosthetic valve remains competent when the retainer is deformed into a non-circular shape by engagement with the tissue.

18. The device of claim 17 wherein the C-shaped ribs have a first radius of curvature in an unbiased state, and wherein the C-shaped ribs are configured to be deformed in a deployed configuration such that the C-shaped ribs have a second radius of curvature, the second radius of curvature being smaller or greater than the first radius of curvature.

19. A prosthetic heart valve device for treating a mitral valve, comprising:
a valve support configured to support a valve;
a ring-shaped retainer coupled to the valve support and positioned at an inflow end of the device, wherein the retainer is positionable between the native valve leaflets at least partially along a subannular surface of a native mitral valve annulus, and wherein the retainer is configured to form a fluid seal with heart tissue and to inhibit upstream migration of the device;
wherein, when the prosthetic heart valve device is in a deployed configuration, the valve support is positioned radially inward from the retainer and an upstream region of the valve support overlaps a portion of the retainer along a longitudinal axis of the prosthetic heart valve device; and
wherein the retainer is coupled to the valve support so as to mechanically isolate the valve support from distorting force exerted on the retainer by native anatomy and thereby maintain the valve support in a substantially cylindrical shape when the retainer is formed into a non-circular shape by the distorting force applied to the retainer by the native anatomy.

20. The device of claim 19 wherein the retainer is configured to engage valve tissue selected from an inward-facing surface of the annulus and an inward facing surface of the leaflets downstream of the annulus.

21. The device of claim 19 wherein the device is moveable into a plurality of configurations including:
a first configuration in which the valve support and the retainer are radially contracted, and wherein the valve support has a first cross-sectional shape;
a second configuration in which the valve support an

Assignees

• Twelve Inc

Inventors

• Morriss John
• Gifford Iii Hanson
• Fann James I
• Dueri Jean-Pierre
• Gittings Darin
• Luna Michael
• Deem Mark
• Sutton Douglas

Classifications

• A61F2/2418 Primary

  Scaffolds therefor, e.g. support stents · CPC title

• A61F2/2436

  Deployment by retracting a sheath · CPC title

• A61F2250/006

  modular · CPC title

• A61F2220/0016

  with sharp anchoring protrusions, e.g. barbs, pins, spikes · CPC title

• A61F2220/0025

  Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements · CPC title