IP Library › Granted Patent US 12,672,958
Granted Patent B2
US 12,672,958 · App. 17/502,018 · Granted Jul 7, 2026

Sealing member for prosthetic heart valve

Inventors: Ziv Yohanan (Kfar Hahoresh, IL); Tamir S. Levi (Zikhron Yaakov, IL); David Maimon (Atlit, IL); Michael G. Valdez (Riverside, CA); Tram Ngoc Nguyen (Santa Ana, CA)
Assignee: Edwards Lifesciences Corporation
A61F2/2418A61F2/2433A61F2/2436A61F2/246A61F2220/0016A61F2220/005A61F2220/0075A61F2250/0039A61F2250/006A61F2250/0069
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Quick Facts
Patent No.
US 12,672,958
App. No.
17/502,018
Granted
Jul 7, 2026
Kind
B2
Abstract

An implantable prosthetic valve can include an annular frame comprising an inflow end and an outflow end and being radially collapsible and expandable between a radially collapsed configuration and a radially expanded configuration. A leaflet structure can be positioned within the frame and secured thereto. An outer skirt can be positioned around an outer surface of the frame and secured to the frame and an annular sealing member can be positioned around an outer surface of the outer skirt and secured to the outer skirt.

Claims (33)

1 . An implantable prosthetic valve comprising:

an annular frame comprising an inflow end and an outflow end and being radially collapsible and expandable between a radially collapsed configuration and a radially expanded configuration;

a leaflet structure positioned within the frame and secured thereto;

an outer skirt positioned around an outer surface of the frame and secured thereto; and

an annular sealing member disposed around and secured to an outer surface of the outer skirt, wherein the annular sealing member is formed of a plurality of interconnected, angled projections that extend radially outward from the outer surface of the outer skirt, the plurality of interconnected, angled projections comprising a plurality of first angled portions having a first orientation with respect to the frame and a plurality of second angled portions having a second orientation with respect to the frame, wherein the sealing member is further formed of a plurality of apices, wherein each first angled portion is connected to a second angled portion at an apex of the plurality of apices such that there is an angle between each first angled portion and a connected second angled portion, wherein the angled projections are made of a material that is configured to absorb blood and expand, and wherein the angled projections form an outermost radially facing surface of the sealing member for sealing against native tissue, and

wherein the outer skirt has a plurality of openings that are axially aligned with a portion of apices of the plurality of apices at an end of the sealing member that is spaced away from the inflow end of the frame.

2 . The prosthetic valve of claim 1 , wherein the plurality of interconnected, angled projections forms a zig-zag shape.

3 . The prosthetic valve of claim 1 , wherein at least one of the plurality of apices has a relatively pointed edge.

4 . The prosthetic valve of claim 1 , wherein the angle is less than 90 degrees.

5 . The prosthetic valve of claim 1 , wherein the angle is greater than 90 degrees.

6 . The prosthetic valve of claim 1 , wherein the angle is 90 degrees.

7 . The prosthetic valve of claim 1 , wherein the sealing member undulates between an inflow end portion and an outflow end portion of the sealing member, around a circumference of the sealing member, wherein the inflow end portion is disposed at the inflow end of the frame.

8 . An implantable prosthetic valve comprising:

an annular frame comprising an inflow end and an outflow end and being radially collapsible and expandable between a radially collapsed configuration and a radially expanded configuration;

a leaflet structure positioned within the frame and secured thereto;

an outer skirt positioned around an outer surface of the frame, wherein the outer skirt has a lower edge secured to the frame and an upper edge stitched to the frame such that the outer skirt radially collapses around the outer surface of the frame when the frame is collapsed to the radially collapsed configuration and radially expands around the outer surface of the frame when the frame is expanded to the radially expanded configuration; and

an annular sealing member positioned around and conforming to an outer surface of the outer skirt such that an inner surface of the sealing member lies flat against the outer surface of the outer skirt from an inflow end portion to an outflow end portion of the sealing member when the frame is in the radially expanded configuration,

wherein the inflow end portion of the sealing member is located at the inflow end of the frame, and

wherein the annular sealing member comprises a plurality of interconnected, angled projections that form an outermost radial surface of the annular sealing member that can contact and seal against native tissue.

9 . The prosthetic valve of claim 8 , wherein the sealing member comprises a sponge or foam material.

10 . The prosthetic valve of claim 8 , wherein the sealing member comprises a material that is configured to absorb blood and expand.

11 . The prosthetic valve of claim 8 , wherein the inflow end portion of the sealing member is disposed at an inflow end of the outer skirt that is disposed at the inflow end of the frame, and wherein the outflow end portion of the sealing member is disposed away from the inflow end and toward an outflow end of the outer skirt.

12 . An implantable prosthetic valve comprising:

an annular frame comprising an inflow end and an outflow end and being radially collapsible and expandable between a radially collapsed configuration and a radially expanded configuration;

a leaflet structure positioned within the frame and secured thereto;

an outer skirt positioned around an outer surface of the frame, wherein the outer skirt has a lower edge secured to the frame and an upper edge secured to the frame via stitches such that the outer skirt radially collapses around the outer surface of the frame when the frame is collapsed to the radially collapsed configuration and radially expands around the outer surface of the frame when the frame is expanded to the radially expanded configuration; and

a sealing member disposed on and projecting radially outward from an outer surface of the outer skirt, wherein the sealing member is made of a material that absorbs blood and does not overlap itself when the annular frame is in the radially collapsed configuration.

13 . The prosthetic valve of claim 12 , wherein the outer skirt comprises a first material and the sealing member comprises a second material, wherein the second material is different than the first material.

14 . The prosthetic valve of claim 13 , wherein the first material is a fabric.

15 . The prosthetic valve of claim 14 , wherein the second material comprises a material that is configured to absorb blood and expand.

16 . The prosthetic valve of claim 12 , wherein the sealing member extends completely around the outer skirt.

17 . The prosthetic valve of claim 12 , wherein the sealing member is stitched to the outer skirt.

18 . The prosthetic valve of claim 12 , wherein the sealing member has an upper end spaced axially from the upper edge of the outer skirt.