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

Patent metadata

Field	Value
Publication number	US-10016271-B2
Application number	US-201214352969-A
Country	US
Kind code	B2
Filing date	Oct 19, 2012
Priority date	Oct 19, 2011
Publication date	Jul 10, 2018
Grant date	Jul 10, 2018

Abstract

A prosthetic heart valve ( 100 ) includes a flexible anchoring member ( 110 ) at least partially surrounding and coupled to an inner valve support ( 120 ). The device can further include a prosthetic valve ( 130 ) coupled to, mounted within, or otherwise carried by the valve support. The valve support includes a plurality of posts ( 122 ) connected circumferentially by a plurality of struts ( 124 ), where the posts extend along an axial direction generally parallel to the longitudinal axis ( 101 ) and the struts extend circumferentially around and transverse to the longitudinal axis. The posts extend an entire longitudinal height HI of the valve support 120 . The device also includes one or more sealing members ( 140 ) and tissue engaging elements ( 170 ) like spikes.

First claim

We claim:

1. A prosthetic heart valve device for implantation at a native heart valve, the native heart valve having an annulus and leaflets, comprising:
an anchoring member positionable in a location between the leaflets, the anchoring member having a first portion and a second portion, wherein the first portion of the anchoring member is expandable to a deployed configuration having a dimension larger than a corresponding dimension of the annulus such that upstream movement of the anchoring member is blocked by engagement of the first portion of the anchoring member with tissue on or near the annulus on an inward-facing side of the leaflets, wherein the first portion of the anchoring member comprises an upstream portion and the second portion of the anchoring member comprises a downstream portion; and
a valve support coupled to the second portion of the anchoring member and configured to support a prosthetic valve, the valve support having an expanded configuration in which the prosthetic valve is competent,
wherein, when the valve support is in the expanded configuration and the anchoring member is in the deployed configuration, an upstream end of the valve support is spaced radially inward from and longitudinally aligned with the first portion of the anchoring member such that if the anchoring member is deformed inwardly the upstream end of the valve support remains substantially undeformed.

2. The device of claim 1 wherein the first portion of the anchoring member is configured to engage valve tissue selected from an inward-facing surface of the annulus and an inward facing surface of the leaflets under the annulus.

3. The device of claim 1 wherein the valve support extends around a longitudinal axis, and wherein the first portion of the anchoring member flares outward from the longitudinal axis by a taper angle.

4. The device of claim 3 wherein the taper angle continuously changes between the first portion and the second portion.

5. The device of claim 3 wherein the taper angle varies around a circumference of the first portion.

6. The device of claim 3 wherein the taper angle is between approximately 30° to about 75°.

7. The device of claim 3 wherein the taper angle is between approximately 40° to about 60°.

8. The device of claim 1 wherein the first portion of the anchoring member includes a flared portion and a vertical portion, the vertical portion is configured to radially expand and engage the annulus.

9. The device of claim 8 wherein the flared portion includes tissue engaging elements configured to engage subannular tissue.

10. The device of claim 1 wherein the first portion is radially separated from the valve support by a gap.

11. The device of claim 1 , further comprising a skirt overlying a surface of the anchoring member, the skirt configured to inhibit blood flow between the anchoring member and the valve support.

12. The device of claim 1 , further comprising a sealing member coupled to the anchoring member configured to inhibit blood flow between the anchoring member and the tissue.

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 wherein the first portion of the anchoring member has a first flexibility and the valve support has a second flexibility less than the first flexibility such that a region of the valve support remains substantially undistorted when the first portion of the anchoring member distorts to the native heart valve.

16. The device of claim 1 wherein:
the anchoring member is defined by a structure separate from the valve support; the valve support is coupled to the anchoring member at the second portion of
the anchoring member; and
the second portion of the anchoring member is longitudinally spaced apart from the first portion of the anchoring member.

17. The device of claim 1 wherein the anchoring member resists upstream migration of the device without any element of the device extending behind the leaflets of the native mitral valve.

18. The device of claim 1 , further comprising a plurality of tissue engaging elements configured to engage tissue of the annulus or leaflets.

19. The device of claim 18 wherein the tissue engaging elements have:
a piercing configuration in which the tissue engaging elements have a low profile for penetrating the tissue; and
a retaining configuration in which the tissue engaging elements have an expanded profile for maintaining the tissue engaging element within the tissue.

20. The device of claim 1 , further comprising a second anchoring structure coupled to the first portion of the anchoring member and extending outwardly so as to engage tissue on or near the annulus.

21. The device of claim 1 wherein:
the valve support comprises an inner frame having an outer surface and an inner surface, the inner surface configured to support a prosthetic valve; and
the anchoring member comprises an outer frame coupled to the inner frame, the outer frame having a first portion with a cross-sectional dimension greater than a corresponding cross-sectional dimension of an annulus of the mitral valve, wherein the first portion is configured to engage tissue at or below the annulus of the heart valve and prevent migration of the device in an upward direction during ventricular systole, and wherein at least the first portion of the frame is mechanically isolated from the inner frame.

22. A device for repair or replacement of a native valve of a heart, the native valve having an annulus and leaflets coupled to the annulus, comprising:
an anchoring member including a first portion and a second portion, wherein the first portion is configured to engage tissue on or under the annulus so as to inhibit movement of the device in an upstream direction and to deform into a non-circular shape to at least partially conform to the shape of the native valve; and
a valve support coupled to the second portion of the anchoring member and configured to support a prosthetic valve, wherein the valve support has a cross-sectional shape, wherein the anchoring member extends upwardly and flares outwardly apart from the valve support from a downstream portion of the valve support;
wherein, when the anchoring member and valve support are in a fully expanded configuration, the first portion of the anchoring member is longitudinally aligned with an upstream end of the valve support and mechanically isolated from the valve support such that the cross-sectional shape of the valve support remains sufficiently stable that the prosthetic valve remains competent when the anchoring member is deformed in the non-circular shape.

23. A prosthetic heart valve device for repair or replacement of a native heart valve of a patient, the heart valve having a native annulus and leaflets, comprising:
an anchoring member having an upstream portion having a first cross-sectional dimension and a downstream portion having a second cross-sectional dimension less than the first cross-sectional dimension, wherein the upstream portion is configured to engage cardiac tissue at the native annulus to restrain the anchoring member from movement in an upstream direction;
a valve support coupled to the downstream portion of the anchoring member and configured to support a prosthetic valve, wherein the valve support has an upstream region and a downstream region, and wherein, wit

Assignees

• Twelve Inc

Inventors

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

Classifications

• A61F2220/0075

  sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable · CPC title

• A61F2230/0054

  V-shaped · CPC title

• A61F2/246

  Devices for obstructing a leak through a native valve in a closed condition · CPC title

• A61F2230/0067

  conical · CPC title

• A61F2250/006

  modular · CPC title