IP Library › Granted Patent US 10,849,742
Granted Patent B2
US 10,849,742 · App. 16/694,203 · Granted Dec 1, 2020

Prosthetic heart valve

Inventors: Tamir S. Levi (Zikhron Yaakov, IL); Son V. Nguyen (Irvine, CA); Netanel Benichou (D.n. Hof Hacarmel, IL); David Maimon (Atlit, IL); Ziv Yohanan (Kfar Hahoresh, IL); Nikolay Gurovich (Hadera, IL); Bella Felsen (Hiafa, IL); Larisa Dadonkina (Or Akiva, IL); Ron Sharoni (Hadera, IL); Elena Sherman (Pardes Hana, IL)
Assignee: Edwards Lifesciences Corporation
A61F2/2418A61F2/2412A61F2/2433A61F2220/0075A61F2230/0054A61F2250/0036A61F2250/0097
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Quick Facts
Patent No.
US 10,849,742
App. No.
16/694,203
Granted
Dec 1, 2020
Kind
B2
Abstract

Embodiments of a radially collapsible and expandable prosthetic heart valve are disclosed. A valve frame can have a tapered profile when mounted on a delivery shaft, with an inflow end portion having a smaller diameter than an outflow end portion. The valve can comprise generally V-shaped leaflets, reducing material within the inflow end of the frame. An outer skirt can be secured to the outside of the inflow end portion of the frame, the outer skirt having longitudinal slack when the valve is expanded and lying flat against the frame when the valve is collapsed. A diagonally woven inner skirt can elongate axially with the frame. Side tabs of adjacent leaflets can extend through and be secured to window frame portions of the frame to form commissures. The window frame portions can be depressed radially inward relative to surrounding frame portions when the valve is crimped onto a delivery shaft.

Claims (27)

1. A prosthetic heart valve, comprising:

a radially expandable annular frame comprising a cobalt-chromium alloy, the frame having an inflow end portion defining an inflow end of the frame that is configured to receive antegrade blood flow into the prosthetic heart valve when implanted within a patient's body in a radially expanded configuration, and the annular frame also having an outflow end portion defining an outflow end of the frame opposite the inflow end of the frame;

a leaflet structure positioned within the frame; and

an inner skirt comprising a fabric of woven fibers and extending around an inner surface of the inflow end portion of the frame, wherein the inner skirt has an inflow edge oriented toward the inflow end of the frame, an outflow edge oriented toward the outflow end of the frame and forming an undulated shape, a first lateral edge, and a second lateral edge, wherein the first lateral edge and the second lateral edge are secured together such that the inner skirt forms a ring, and wherein the first lateral edge and the second lateral edge are oriented at an oblique angle relative to the inflow edge of the inner skirt;

wherein the fabric of woven fibers includes first fibers that extend at the oblique angle and parallel to the first and second lateral edges, and includes second fibers that extend transverse to the first fibers and transverse to the first and second lateral edges.

2. The valve of claim 1 , wherein the first lateral edge overlaps with the second lateral edge, and the first lateral edge and the second lateral edge are secured together with a diagonally extending suture line that is oriented at the oblique angle relative to the inflow edge of the inner skirt.

3. The valve of claim 1 , wherein the oblique angle is about 45 degrees.

4. The valve of claim 1 , wherein the inner skirt has a generally rhomboid shape when the first and second lateral edges are unsecured to each other and the inner skirt is laid flat.

5. The valve of claim 1 , wherein the outflow edge of the inner skirt comprises projections and notches that correspond& with a row of struts of the frame.

6. The valve of claim 1 , wherein the inner skirt comprises PET.

7. The valve of claim 1 , wherein the leaflet structure is secured to the annular frame at three commissures, wherein the inner skirt has two inflow corners at intersections of the inflow edge with the first and second lateral edges, and wherein the inflow corners are positioned in axial alignment with one of the three commissures.

8. The valve of claim 1 , wherein the leaflet structure is secured to the annular frame at three commissures, wherein the inner skirt has two outflow corners at intersections of the outflow edge with the first and second lateral edges, and wherein the outflow corners are positioned midway between two of the three commissures.

9. The valve of claim 1 , wherein inflow edges of the leaflet structure are secured to the inner skirt via a curved line of sutures, and the curved line of sutures crosses the first and second lateral edges of the inner skirt.

10. The valve of claim 1 , wherein the outflow edge of the inner skirt comprises 12 projections and 12 notches, and one of the notches is located at an outflow end of the first lateral edge.

11. An inner skirt for a plastically-expandable prosthetic heart valve, comprising:

a fabric sheet comprising woven fibers and having an inflow edge, an outflow edge, a first lateral edge, and a second lateral edge;

wherein the outflow edge forms an undulated shape;

wherein the first lateral edge and the second lateral edge are secured together such that the inner skirt forms a cylindrical shape; and

wherein the first lateral edge and the second lateral edge are oriented at an oblique angle relative to the inflow edge of the inner skirt;

wherein the woven fibers include first fibers that extend at the oblique angle and parallel to the first and second lateral edges, and includes second fibers that extend transverse to the first fibers and transverse to the first and second lateral edges.

12. The inner skirt of claim 11 , wherein the first lateral edge overlaps with the second lateral edge, and the first lateral edge and the second lateral edge are secured together with a diagonally extending suture line that is oriented at the oblique angle relative to the inflow edge of the inner skirt.

13. The inner skirt of claim 11 , wherein the oblique angle is about 45 degrees.

14. The inner skirt of claim 11 , wherein the fabric sheet has a generally rhomboid shape when the first and second lateral edges are unsecured to each other and the fabric sheet is laid flat.

15. The inner skirt of claim 11 , wherein the fabric sheet comprises PET.

16. The inner skirt of claim 11 , wherein the outflow edge comprises projections and notches that define the undulated shape.

17. The inner skirt of claim 16 , wherein the outflow edge comprises 12 projections and 12 notches.

18. The inner skirt of claim 17 , wherein one of the 12 notches is located at an outflow end of the first lateral edge.

Assignments (2)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jan 28, 2020
From: LEVI, TAMIR S.; NGUYEN, SON V.; BENICHOU, NETANEL; MAIMON, DAVID; YOHANAN, ZIV; GUROVICH, NIKOLAY; FELSEN, BELLA; DADONKINA, LARISA
To: EDWARDS LIFESCIENCES CORPORATION
Reel/Frame 051648/0142 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jan 28, 2020
From: SHARONI, RON; SHERMAN, ELENA
To: EDWARDS LIFESCIENCES CORPORATION
Reel/Frame 051648/0221 →
Continuity (7)
Continuation 16657915 · Oct 18, 2019
Continuation 16516089 · Jul 18, 2019
Continuation 15194375 · Jun 27, 2016
Continuation 13253689 · Oct 5, 2011
Provisional Application 61508513 · Jul 15, 2011
Provisional Application 61390107 · Oct 5, 2010
Related Publication 20200093591A1 · Mar 26, 2020