Replacement heart valve prosthesis

Patent metadata

Field	Value
Publication number	US-11224507-B2
Application number	US-201916506886-A
Country	US
Kind code	B2
Filing date	Jul 9, 2019
Priority date	Jul 21, 2016
Publication date	Jan 18, 2022
Grant date	Jan 18, 2022

Abstract

A heart valve prosthesis for replacing a native mitral valve includes a self-expanding frame with a plurality of anchoring members disposed along the lower region. A valve body is positioned within the self-expanding frame and includes a plurality of leaflets configured to allow blood flow through the self-expanding frame in only one direction. A skirt surrounds the self-expanding frame and is spaced apart therefrom for contacting surrounding tissue and impeding blood flow around the self-expanding frame. The skirt may be reinforced with wires to help maintain a desired shape. The leaflets in the valve body are preferably connected to the self-expanding frame through one or more intermediate components such that the valve body is spaced radially inwardly from an inner surface of the self-expanding frame.

First claim

What is claimed is:

1. A heart valve prosthesis for replacing a native mitral valve, comprising:
a self-expanding frame having an upper region, an intermediate region and a lower region, the self-expanding frame comprising an inner frame and a supplemental outer frame, the self-expanding frame including a plurality of anchoring members extending outward from the lower region of the self-expanding frame and then upward toward the upper region of the self-expanding frame so as to facilitate capturing of the native mitral valve by at least some of the plurality of anchoring members;
a valve body positioned within the self-expanding frame, the valve body comprising a plurality of leaflets configured to allow blood flow through the self-expanding frame in a first direction and to prevent blood flow through the self-expanding frame in a second direction; and
a skirt surrounding and spaced apart from an outer surface of the self-expanding frame, the skirt configured to contact surrounding tissue and impede blood flow around the self-expanding frame;
wherein each of the plurality of leaflets has an arcuate proximal edge and a free distal edge, the plurality of leaflets being joined at commissures and wherein one or more intermediate components connect the plurality of leaflets to the self-expanding frame such that, when the self-expanding frame is in an expanded configuration, the one or more intermediate components allow the commissures to be spaced radially inwardly from an inner surface of the self-expanding frame, and
wherein the inner frame and the supplemental outer me are attached together at the upper region of the self-expanding frame.

2. The heart valve prosthesis of claim 1 , wherein the one or more intermediate components is formed from a material having a stiffness greater than that of the plurality of leaflets and less than that of the self-expanding frame.

3. The heart valve prosthesis of claim 1 , wherein the leaflets are made from pericardium.

4. The heart valve prosthesis of claim 1 , wherein a diameter of the valve body is smaller than a diameter of the inner frame.

5. The heart valve prosthesis of claim 1 , wherein the one or more intermediate components are made from fabric.

6. The heart valve prosthesis of claim 1 , further comprising locking tabs adjacent the upper region of the self-expanding frame.

7. The heart valve prosthesis of claim 1 , wherein the one or more intermediate components form one or more pockets between the valve body and the inner frame.

8. The heart valve prosthesis of claim 7 , wherein the pockets are fully enclosed.

9. The heart valve prosthesis of claim 8 , wherein the one or more intermediate components are formed of a porous material that allows blood to enter the pockets.

10. The heart valve prosthesis of claim 1 , wherein the skirt is formed from an upper component, a middle component and a lower component.

11. The heart valve prosthesis of claim 10 , wherein the upper component of the skirt is attached to the upper region of the self-expanding frame.

12. The heart valve prosthesis of claim 11 , wherein the lower component of the skirt is attached to the lower region of the self-expanding frame.

13. The heart valve prosthesis of claim 1 , wherein the skirt further comprises wires formed from a resilient material for allowing the skirt to retain a particular shape.

14. The heart valve prosthesis of claim 1 , wherein the supplemental outer frame is formed separately from the inner frame, and wherein the inner frame and the supplemental outer frame are attached together via sutures.

15. The heart valve prosthesis of claim 1 , wherein the self-expanding frame is non-cylindrical.

16. The heart valve prosthesis of claim 1 , wherein at least one of the plurality of anchoring members includes a tip portion formed from at least two prongs.

17. A heart valve prosthesis for replacing a native mitral valve, comprising:
a self-expanding frame having an upper region, an intermediate region and a lower region; a plurality of anchoring members extending radially outwardly from the lower region of the self-expanding frame and extending towards the upper region of the self-expanding frame so as to facilitate capturing of the native mitral valve by at least some of the plurality of anchoring members;
a valve body positioned within the self-expanding frame, the valve body comprising a plurality of leaflets configured to allow blood flow through the self-expanding frame in a first direction and to prevent blood flow through the self-expanding frame in a second direction,
wherein each of the plurality of leaflets has an arcuate proximal edge and a free distal edge, the plurality of leaflets being joined at commissures and wherein one or more intermediate components connect the plurality of leaflets to the self-expanding frame such that, when the frame is in an expanded configuration, the one or more intermediate components allow the commissures to be spaced radially inwardly from an inner surface of the self-expanding frame; and
a skirt at least partially surrounding and spaced radially away from an outer surface of the self-expanding frame so as to form a clearance between the outer surface of the self-expanding frame and the skirt, the skirt configured to impede blood flow around the self-expanding frame.

18. The heart valve prosthesis of claim 17 , wherein the self-expanding frame comprises an inner frame and a supplemental outer frame that is formed separately from the inner frame.

19. The heart valve prosthesis of claim 18 , wherein the inner frame and the supplemental outer frame are attached together via sutures.

20. A heart valve prosthesis for replacing a native heart valve, comprising:
a self-expanding frame having art upper region, an intermediate region and a lower region;
a plurality of anchoring members extending radially outwardly from the lower region of the self-expanding frame and extending towards the upper region of the self-expanding frame so as to facilitate capturing of the native valve by at least some of the plurality of anchoring members;
a valve body positioned within the self-expanding frame, the valve body comprising a plurality of leaflets configured to allow blood flow through the self-expanding frame in a first direction and to prevent blood flow through the self-expanding frame in a second direction,
wherein each of the plurality of leaflets has an arcuate proximal edge and a free distal edge, the plurality of leaflets being joined at commissures and wherein one or more intermediate components composed of fabric connect the plurality of leaflets to the self-expanding frame such that, when the frame is in an expanded configuration, the one or more intermediate components allow the commissures to be spaced radially inwardly from an inner surface of the self-expanding frame; and
a skirt at least partially surrounding and spaced radially away from an outer surface of the self-expanding frame, the skirt configured to impede blood flow around the self-expanding frame.

Assignees

• Edwards Lifesciences Corp

Inventors

• Peterson Matthew A
• Yi Seung-Beom
• Vad Siddharth
• Oba Travis Zenyo
• Freschauf Lauren R
• French Amanda
• Keidar Yaron
• Du Yuanlong
• Bak-Boychuk Gregory
• Golemo Kevin M
• Cooper Alexander H

Classifications

• A61F2250/0069

  Sealing means · CPC title

• A61F2250/0014

  having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis · CPC title

• A61F2/2427

  Devices for manipulating or deploying heart valves during implantation · CPC title

• A61F2/2418 Primary

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

• A61F2/2412 Primary

  with soft flexible valve members, e.g. tissue valves shaped like natural valves · CPC title