Prosthetic heart valve devices, prosthetic mitral valves and associated systems and methods

Patent metadata

Field	Value
Publication number	US-11197758-B2
Application number	US-201916375301-A
Country	US
Kind code	B2
Filing date	Apr 4, 2019
Priority date	Oct 19, 2011
Publication date	Dec 14, 2021
Grant date	Dec 14, 2021

Abstract

Devices and methods for implantation at a native mitral valve having a non-circular annulus and leaflets. One embodiment of the device includes a valve support having a first region configured to be attached to a prosthetic valve with a plurality of prosthetic leaflets and a second region. The device can further include an anchoring member having a longitudinal dimension and including a first portion configured to contact tissue at the non-circular annulus, a second portion configured to be attached to the valve support, and a lateral portion between the first portion and the second portion. The second portion of the anchoring member is attached to the second region of the valve support while in a low-profile configuration in which the anchoring member and the valve support are configured to pass through vasculature of a human. The lateral portion is transverse to the longitudinal dimension. The anchoring member and the valve support are configured to move from the low-profile configuration to an expanded configuration in which the first portion of the anchoring member at least partially adapts to the non-circular annulus of the native mitral valve and the first region of the valve support is spaced inwardly from the first portion of the anchoring member relative to the longitudinal dimension of the anchoring member such that a shape of the first region of the valve support is at least partially independent of a shape of the first portion of the anchoring member.

First claim

We claim:

1. A prosthetic heart valve device for treating a valve of a human heart having a native annulus and native leaflets, the device comprising:
an inner frame;
a prosthetic valve disposed within the inner frame; and
an anchoring member including a connection structure fixedly attached to the inner frame before deployment of the prosthetic heart valve device and an outer frame having interconnected struts that define an outwardly facing engagement surface configured to engage an inwardly facing surface of the native annulus, wherein, in a deployed state, the outer frame is spaced radially outward from the inner frame and the engagement surface exerts a radially outward force against an inner surface of the native annulus to affix the device to the native annulus.

2. The device of claim 1 wherein, at an elevation corresponding to an inflow region of the inner frame, the inflow region of the inner frame is separated from an inflow region of the outer frame by a gap.

3. The device of claim 2 wherein the inflow region of the outer frame is configured to deflect inwardly toward the inner frame when the engagement surface exerts the radially outward force against the inner surface of the native annulus.

4. The device of claim 1 wherein, in an expanded state, a portion of the outer frame has a cylindrical shape surrounding the inner frame.

5. The device of claim 1 wherein the outer frame has a plurality of tissue engaging elements projecting outwardly from the engagement surface in an upstream direction relative to a direction of blood flow during diastole.

6. The device of claim 1 , further comprising a fabric flexibly coupled between the inner frame and the outer frame proximate to an inlet region of the prosthetic valve.

7. The device of claim 1 , further comprising an atrial retainer coupled to the outer frame, wherein the atrial retainer extends laterally outward from an upstream end of the outer frame.

8. A prosthetic heart valve device for treating a valve of a human heart having a native annulus and native leaflets, the device comprising:
a valve support extending around a longitudinal axis, wherein the valve support has an upstream region and a downstream region, wherein the upstream region includes an upstream end of the valve support;
a prosthetic valve having a plurality of leaflets carried by the valve support; and
an anchoring member having an outer frame completely surrounding the upstream region of the valve support at a position along the longitudinal axis substantially the same as the upstream region of the valve support, wherein the anchoring member is resiliently biased to a deployed state in which the outer frame is spaced radially apart from the inner frame and is thereby configured to exert a radially outward force against an inner surface of the native annulus that secures the heart valve device to the native annulus.

9. The device of claim 8 wherein the outer frame comprises a plurality of interconnected struts that extend circumferentially about the outer frame.

10. The device of claim 9 wherein the interconnected struts have a diamond-like configuration.

11. The device of claim 8 wherein the outer frame has an outwardly-facing engagement surface configured to press against the inner surface of the native annulus, and the outer frame is configured to be positioned between the native annulus and the valve support in the deployed state when the engagement surface presses against the inner surface of the native annulus.

12. The device of claim 8 , further comprising an atrial retainer coupled to the outer frame, and wherein the atrial retainer extends laterally outward from an upstream end of the outer frame.

13. The device of claim 8 wherein the outer frame has an outwardly-facing engagement surface configured to press against the inner surface of the native annulus, and wherein the device further comprises a plurality of engagement elements projecting outwardly from the engagement surface.

14. The device of claim 8 , further comprising a web of flexible material extending between the valve support and the outer frame proximate to an inlet region of the prosthetic valve.

15. A prosthetic heart valve device for treating a valve of a human heart having a native annulus and native leaflets, the device comprising:
a valve support having an upstream region and a downstream region relative to a direction of blood flow during diastole, wherein the valve support is configured to retain a prosthetic valve in at least the upstream region; and
an anchoring member comprising an outer cylindrical frame having interconnected struts that define an outwardly-facing engagement surface configured to engage an inwardly-facing surface of the native annulus, wherein, in a deployed state, the outer frame is spaced radially outward from the valve support such that the engagement surface is configured to exert a radially outward force against the inwardly-facing surface of the native annulus that secures the device to the native annulus.

16. The device of claim 15 wherein, when the device is in an unbiased expanded state, the valve support has a first diameter and the outer frame has a second diameter greater than the first diameter at an elevation corresponding to the upstream region.

17. The device of claim 15 wherein the interconnected struts have a diamond-like configuration.

18. The device of claim 15 , further comprising an atrial retainer coupled to the anchoring member, wherein the atrial retainer extends laterally outward from an upstream portion of the outer frame and is configured to extend over a supra-annular surface of the native annulus.

19. The device of claim 18 wherein the atrial retainer is integrally formed with the outer frame.

20. The device of claim 18 wherein the atrial retainer comprises a plurality of ribs and a covering extending over at least a portion of the fingers.

21. The device of claim 1 , wherein the outer frame of the anchoring member completely surrounds an upstream region of the inner frame, and wherein an upstream region of the outer frame is cylindrical.

Assignees

• Twelve Inc

Inventors

• Mclean Matt
• Morriss John
• Gifford Iii Hanson

Classifications

• A61F2/2418 Primary

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

• A61F2220/0066

  stapled · CPC title

• A61F2220/0041

  using additional screws, bolts, dowels or rivets, e.g. connecting screws · CPC title

• A61F2230/0078

  hyperboloidal · CPC title

• A61F2/2436

  Deployment by retracting a sheath · CPC title