Prosthetic mitral valve with improved anchors and seal

Patent metadata

Field	Value
Publication number	US-11051934-B2
Application number	US-201916286436-A
Country	US
Kind code	B2
Filing date	Feb 26, 2019
Priority date	Feb 28, 2018
Publication date	Jul 6, 2021
Grant date	Jul 6, 2021

Abstract

A mitral valve prosthesis includes an hourglass shaped inner frame and a bulbous outer frame. A valve body having a plurality of leaflets is positioned within an interior region of the inner frame. The leaflets are shaped to substantially conform to an interior surface of the inner frame when the leaflets are in an open position. As a result, the gap between the leaflets and the inner frame is decreased, thereby reducing the likelihood of thrombus formation. Ventricular anchors are preferably provided along a distal end of the inner frame. The anchors extend proximally for placement behind native mitral valve leaflets. A fabric skirt may extend along an inner or outer surface of the outer frame. In preferred embodiments, the fabric skirt extends distally beyond a distal end of the outer frame and is adapted for forming a seal along the mitral valve annulus.

First claim

What is claimed is:

1. A mitral valve prosthesis configured to transition between a compressed configuration and an expanded configuration, the prosthesis having a proximal end and a distal end, the prosthesis comprising:
an inner frame comprising:
a body comprising:
a plurality of circumferentially extendable struts with respect to a longitudinal axis of the inner frame; and
a plurality of longitudinally extending struts with respect to the longitudinal axis of the inner frame;
wherein the plurality of circumferentially extendable struts and the plurality of longitudinally extending struts form two or more rows of cells; and

a plurality of inner frame anchoring features extending distally from the body;
wherein the body of the inner frame tapers radially inward from a first larger diameter at a proximal end of the body to a narrowest diameter of an intermediate region of the body and then tapers radially outward from the narrowest diameter of the intermediate region of the body to a second larger diameter at a distal end of the body so as to form a curved hourglass shape when the prosthesis is in the expanded configuration;

an outer frame connected to the inner frame,
wherein a longitudinal length of the outer frame overlaps with at least the intermediate region of the body of the inner frame when the prosthesis is in the expanded configuration;

a valve body connected to a curved interior surface of the inner frame formed by the curved hourglass shape of the body of the inner frame, the valve body comprising a plurality of leaflets arranged to allow blood flow in a first direction and prevent blood flow in a second direction opposite the first direction, wherein the leaflets are adapted to have a longitudinal curvature when the valve body is in an open configuration that follows the curved hourglass shape of the body of the inner frame and conforms to and lies flush against the curved interior surface of the inner frame when the prosthesis is in the expanded configuration, thereby reducing a formation of thrombi between the plurality of leaflets and the curved interior surface of the inner frame; and
a fabric skirt connected to an inner surface of the outer frame and extending distally beyond a distal end of the outer frame, wherein the fabric skirt is adapted for contacting a mitral valve annulus and forming a seal between the prosthesis and the mitral valve annulus.

2. The mitral valve prosthesis of claim 1 , wherein the outer frame comprises a plurality of connected first v-shaped struts extending around a circumference of the outer frame; and a plurality of second v-shaped struts, each of the second v-shaped struts positioned within gaps formed between each of the connected first v-shaped struts and attached to adjacent pairs of the connected first v-shaped struts, wherein the plurality of second v-shaped struts are thinner than the plurality of connected first v-shaped struts.

3. The mitral valve prosthesis of claim 2 , wherein the outer frame comprises a plurality of proximally extending struts extending between connections of adjacent connected first v-shaped struts.

4. The mitral valve prosthesis of claim 1 , further comprising one or more sutures attached to the outer frame, the inner frame, and the plurality of inner frame anchoring features, the one or more sutures providing tension to the inner frame anchoring features when the prosthesis is in the expanded configuration and not providing tension to the inner frame anchoring features when the prosthesis is in the compressed configuration.

5. The mitral valve prosthesis of claim 1 , wherein the plurality of inner frame anchoring features extend radially outwardly and then proximally toward the proximal end of the prosthesis when the prosthesis is in the expanded configuration, wherein each of the plurality of inner frame anchoring features ends with an anchoring tip.

6. The mitral valve prosthesis of claim 5 , wherein each anchoring tip at the end of each of the plurality of inner frame anchoring features is located proximal to the distal end of the outer frame and is spaced radially outward of the outer frame when the prosthesis is in the expanded configuration such that native leaflets of the mitral valve are configured to be trapped in a space between at least one of the anchoring tips and the outer frame.

7. The mitral valve prosthesis of claim 1 , wherein the distal end of the outer frame ends proximal to a distal end of the two or more rows of cells of the body of the inner frame.

8. The mitral valve prosthesis of claim 1 , wherein the inner frame comprises a mushroom-shaped tab at a proximal end of at least one of the plurality of longitudinally extending struts.

9. The mitral valve prosthesis of claim 1 , wherein the inner frame comprises a plurality of apertures at or near a proximal end of the inner frame, wherein the outer frame comprises a plurality of apertures at or near a proximal end of the outer frame, and wherein each one of the plurality of apertures of the inner frame generally aligns with a respective one of the plurality of apertures of the outer frame.

10. The mitral valve prosthesis of claim 1 , wherein the outer frame comprises a circumferential shoulder spaced from a proximal end of the outer frame and the distal end of the outer frame, the circumferential shoulder being the radially outermost portion of the outer frame.

11. The mitral valve prosthesis of claim 1 , wherein the plurality of inner frame anchoring features comprises nine inner frame anchoring features.

12. The mitral valve prosthesis of claim 1 , wherein free edges of a distal end of each of the plurality of leaflets are spaced away from the inner frame.

13. The mitral valve prosthesis of claim 1 , wherein the fabric skirt is connected to an outer surface of the distal end of the body of the inner frame, and wherein the fabric skirt is held in tension between the outer frame and the inner frame.

14. The mitral valve prosthesis of claim 1 , wherein the fabric skirt has sufficient flexibility to conform against a mitral valve annulus.

15. A mitral valve prosthesis configured to transition between a compressed configuration and an expanded configuration, the prosthesis having a proximal end and a distal end, the prosthesis comprising:
an inner frame comprising:
a body comprising:
a plurality of circumferentially extendable struts; and
a plurality of longitudinally extending struts;
wherein the plurality of circumferentially extendable struts and the plurality of longitudinally extending struts form two or more rows of cells; and

a plurality of inner frame anchoring features extending distally from the body;
wherein the body of the inner frame comprises an upper region, an intermediate region, and a lower region,
wherein the intermediate region has a narrower diameter than both the upper region and the lower region when the prosthesis is in the expanded configuration so as to form an interior surface that tapers radially inward from the upper region toward the intermediate region and tapers radially outward from the intermediate region to the lower region;

an outer frame connected to the inner frame,
wherein, when the prosthesis is in the expanded configuration, the outer frame comprises a bulbous shape in which a circumferential shoulder of the outer frame is spaced from a proximal end of the outer frame and a distal end of the outer frame, the circumferential shoulder being the radially outermost portion of the outer frame,
wherein at least the intermediate region of the inner frame is positioned radially within a portion of a length of the outer fram

Assignees

• Edwards Lifesciences Corp

Inventors

• Cooper Alexander H
• Schwartz Juliet Laura
• Pham Wendy Vo
• Luong Hieu Minh
• Sanchez Julio Cesar
• Peterson Matthew A
• Ratz J Brent
• Ai Lisong

Classifications

• A61F2/2409 Primary

  Support rings therefor, e.g. for connecting valves to tissue (annuloplasty rings A61F2/2442) · CPC title

• A61F2/2418 Primary

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

• A61F2230/001

  Figure-8-shaped, e.g. hourglass-shaped · CPC title

• A61F2230/0054

  V-shaped · CPC title

• A61F2/2439

  Expansion controlled by filaments · CPC title