IP Library › Granted Patent US 12,201,519
Granted Patent B2
US 12,201,519 · App. 17/359,964 · Granted Jan 21, 2025

Prosthetic valve

Inventors: Liron Tayeb (Peduel, IL); Tamir S. Levi (Zikhron Yaakov, IL)
Assignee: EDWARDS LIFESCIENCES CORPORATION
A61F2/2418A61F2/243
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Quick Facts
Patent No.
US 12,201,519
App. No.
17/359,964
Granted
Jan 21, 2025
Kind
B2
Abstract

A prosthetic valve includes an annular frame and a skirt. The frame is radially expandable and compressible between a radially compressed configuration and a radially expanded configuration. The skirt has a fold around an inflow end of the frame so as to cover at least a portion of an outer surface of the frame and at least a portion of an inner surface of the frame. When the frame is in the radially expanded configuration, an outer portion of the skirt tightly conforms to the outer surface of the frame and the inflow end of the frame is axially spaced from the fold to form an axially extending gap between the frame and the fold. When the frame is in the radially compressed configuration, the inflow end of the frame extends axially so as to at least partially fill the axially extending gap.

Claims (30)

1. A prosthetic valve comprising:

an annular frame being radially expandable and compressible between a radially compressed configuration and a radially expanded configuration, wherein the frame comprises a plurality of struts connected to each other at junctions, including a plurality of junctions defining a terminal, inflow end of the frame;

a valvular structure positioned within the frame and configured to permit the flow of blood through the prosthetic valve in one direction and block the flow of blood in an opposing direction; and

an annular skirt having an outer portion covering at least a portion of an outer surface of the frame and an inner portion covering at least a portion of an inner surface of the frame, wherein the skirt is folded around the inflow end of the frame so as to define a fold between the inner portion and outer portion;

wherein the skirt is sized such that when the frame is in the expanded configuration, the outer portion of the skirt conforms to the outer surface of the frame and the junctions at the inflow end of the frame are axially spaced from the fold to form an axially extending gap between the junctions at the inflow end of the frame and the fold, and when the frame is radially compressed from the expanded configuration to the compressed configuration, the junctions at the inflow end of the frame move axially within the gap closer to the fold.

2. The prosthetic valve of claim 1 , wherein the outer portion of the skirt is secured to a row of struts defining an outflow end of the frame.

3. The prosthetic valve of claim 1 , wherein the outer portion of the skirt is stretched in a circumferential direction when the frame is in the expanded configuration.

4. The prosthetic valve of claim 1 , wherein the skirt comprises a non-elastic fabric.

5. The prosthetic valve of claim 4 , wherein the fabric is woven using polyethylene terephthalate fibers in both warp and weft directions.

6. The prosthetic valve of claim 1 , wherein the skirt is woven from a first set of fibers oriented in a first direction and a second set of fibers oriented in a second direction, neither the first nor the second direction being perpendicular to the fold.

7. The prosthetic valve of claim 6 , wherein the first direction is generally perpendicular to the second direction which forms an angle about 45 degrees relative to the fold.

8. The prosthetic valve of claim 1 , wherein the valvular structure comprises a plurality of leaflets, each leaflet having an inflow edge portion, wherein the inflow edge portions of the leaflets define an undulating shape.

9. The prosthetic valve of claim 8 , wherein the inner portion of the skirt has an undulating outflow edge sutured to the inflow edge portions of the leaflets.

10. The prosthetic valve of claim 1 , further comprises a tether coupled to the skirt, wherein the tether is configured to prevent the fold from moving inside the frame when the frame is radially expanded from the compressed configuration to the expanded configuration.

11. A prosthetic valve comprising:

an annular frame having an inflow end and an outflow end, the frame being radially expandable and compressible between a radially compressed configuration and a radially expanded configuration, wherein the frame comprises a plurality of struts connected to each other at junctions, including a plurality of first junctions defining a terminal, inflow end of the frame, and a plurality of second junctions defining a terminal, outflow end of the frame;

a valvular structure positioned within the frame and configured to permit the flow of blood through the prosthetic valve in one direction and block the flow of blood in an opposing direction;

an annular skirt having a fold extending around the inflow end of the frame so as to cover at least a portion of an outer surface of the frame and at least a portion of an inner surface of the frame;

wherein when the frame is in the radially expanded configuration, an outer portion of the skirt tightly conforms to the outer surface of the frame and the first junctions at the inflow end of the frame are axially spaced from the fold to form an axially extending gap between the first junctions at the inflow end of the frame and the fold, and when the frame is in the radially compressed configuration, the first junctions at the inflow end of the frame extend axially so as to at least partially fill the axially extending gap.

12. The prosthetic valve of claim 11 , wherein the valvular structure comprises a plurality of leaflets, each leaflet having an inflow edge portion, wherein the inflow edge portions of the leaflets define an undulating, curved scalloped shape that follows a plurality of interconnected strut segments of the frame along a circumferential direction when the frame is in the radially expanded configuration.

13. The prosthetic valve of claim 11 , wherein the outer portion of the skirt is axially longer than the inner portion of the skirt.

14. The prosthetic valve of claim 11 , wherein the outer portion of the skirt is stretched in a circumferential direction when the frame is in the expanded configuration.

15. The prosthetic valve of claim 11 , further comprising a tether coupled to the skirt and extending at an oblique angle relative to a longitudinal axis of the frame such that the tether applies a tension to the skirt so as to prevent the fold from moving inside the frame when the frame is radially expanded from the compressed configuration to the expanded configuration.

16. A method of implanting a prosthetic valve mounted on a delivery apparatus, the method comprising:

delivering the prosthetic valve in a radially compressed configuration to a target location, wherein the prosthetic valve comprises an annular frame and an annular skirt having a fold around an inflow end of the frame so as to cover at least a portion of an outer surface of the frame and at least a portion of an inner surface of the frame, wherein the frame comprises a plurality of struts connected to each other at junctions, including a plurality of junctions defining a terminal, inflow end of the frame; and

expanding the prosthetic valve to a radially expanded configuration such that an outer portion of the skirt tightly conforms to the outer surface of the frame, and the junctions at the inflow end of the frame move axially away from the fold, thereby forming an axially extending gap between the junctions at the inflow end of the frame and the fold.

17. The method of claim 16 , wherein the prosthetic valve further comprises a valvular structure having a plurality of leaflets, each leaflet having an inflow edge portion, wherein the inflow edge portions of the leaflets define an undulating, curved scalloped shape that follows a plurality of interconnected strut segments of the frame along a circumferential direction when the frame is in the radially expanded configuration.

18. The method of claim 16 , wherein the outer portion of the skirt is stretched in a circumferential direction when the frame is in the expanded configuration.

19. The method of claim 16 , wherein when the frame is in the radially compressed configuration, the junctions at the inflow end of the frame extend axially all the way to the fold so as to completely fill the axially extending gap.

20. The method of claim 16 , wherein the prosthetic valve further comprises a tether coupled to the skirt, wherein the tether is configured to prevent the fold from moving inside the frame when the frame is radially expanded from the compressed configuration to the expanded configuration.

Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Sep 1, 2021
From: TAYEB, LIRON; LEVI, TAMIR S.
To: EDWARDS LIFESCIENCES CORPORATION
Reel/Frame 057354/0446 →
Continuity (3)
Continuation PCTUS2020014701 · Jan 23, 2020
Provisional Application 62797837 · Jan 28, 2019
Related Publication 20210322162A1 · Oct 21, 2021
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