IP Library › Granted Patent US 10,842,622
Granted Patent B2
US 10,842,622 · App. 16/697,983 · Granted Nov 24, 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 10,842,622
App. No.
16/697,983
Granted
Nov 24, 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 (20)

1. A prosthetic heart valve comprising:

a radially expandable annular frame comprising a cobalt-chromium alloy, wherein the frame comprises:

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 an expanded configuration;

an outflow end portion defining an outflow end of the frame opposite the inflow end of the frame; and

an intermediate portion between the inflow end portion and the outflow end portion;

wherein the inflow end, the outflow end, and the intermediate portion of the frame are radially expandable;

wherein the frame further comprises an inflow ring of generally hexagonal openings at the inflow end portion of the frame and an outflow ring of generally hexagonal openings at the outflow end of the frame, the outflow ring of openings being a closest ring of openings to the outflow end of the frame, wherein the generally hexagonal openings of the outflow ring are larger than the generally hexagonal openings of the inflow ring;

wherein the openings of the inflow ring are defined by a circumferentially extending first row of angled struts arranged end-to-end, a circumferentially extending second row of angled struts arranged end-to-end, and a plurality of axially extending struts interconnecting the first and second rows of angled struts; and

wherein each of the axially extending struts joins to a U-shaped crown structure joining adjacent ends of struts of the first row of angled struts and joins to a U-shaped crown structure joining adjacent ends of struts of the second row of angled struts; and

wherein the inflow end portion of the frame comprises a frame thickness (T1) that is less than a frame thickness (T2) of the intermediate portion of the frame;

the prosthetic heart valve further comprising an inner skirt positioned primarily inside the frame, wherein the inner skirt comprises an inflow edge oriented toward the inflow end of the frame, an outflow edge oriented toward the outflow end of the frame, a first lateral edge, and a second lateral edge, wherein the first and second lateral edges of the inner skirt are oriented at an oblique angle relative to the inflow edge of the inner skirt, and wherein the first and second lateral edges of the inner skirt are secured together such that the inner skirt forms an annular shape; and

the prosthetic heart valve further comprising a leaflet structure positioned within the frame between the inflow end and the outflow end of the frame.

2. The valve of claim 1 , wherein the valve has a radially collapsed configuration for delivery into a patient and a radially expanded configuration when implanted in the patient, and wherein in the radially collapsed configuration an outer diameter of the inflow end portion of the frame is smaller than an outer diameter of the outflow end portion of the frame.

3. The valve of claim 2 , wherein a difference between the outer diameters of the outflow end portion of the frame and the inflow end portion of the frame provides radial space for an outer fabric skirt around the inflow end portion of the frame.

4. The valve of claim 3 , wherein in the radially collapsed configuration, an overall outer diameter of an inflow end portion of the prosthetic heart valve, including a radial thickness of the outer fabric skirt positioned around the inflow end portion of the frame, is less than or equal to the outer diameter of the outflow end of the frame.

5. The valve of claim 2 , wherein in the radially collapsed configuration, the outer diameter of the outflow end portion of the frame is 14 French and the outer diameter of the inflow end portion of the frame is 12 French.

6. The valve of claim 1 , wherein the intermediate portion of the frame comprises one or more intermediate rings of openings between the inflow ring and the outflow ring, and the openings of the inflow ring of openings are larger than the openings of the one or more intermediate rings of openings.

7. The valve of claim 6 , wherein the openings of the outflow ring of openings are larger than the openings of the one or more intermediate rings of openings.

8. The valve of claim 6 , wherein the inflow ring of openings comprises 12 hexagonal openings.

9. The valve of claim 1 , further comprising a delivery apparatus comprising a shaft and a balloon on the shaft, wherein the prosthetic heart valve is mounted on the balloon on the shaft in the radially collapsed configuration and configured for delivery into the patient's body.

Assignments (2)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jan 29, 2020
From: LEVI, TAMIR S.; NGUYEN, SON V., MR.; BENICHOU, NETANEL, MR.; MAIMON, DAVID, MR.; YOHANAN, ZIV, MR.; GUROVICH, NIKOLAY, MR; FELSEN, BELLA; DADONKINA, LARISA, MS.
To: EDWARDS LIFESCIENCES CORPORATION
Reel/Frame 051659/0329 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jan 29, 2020
From: SHARONI, RON, MR.; SHERMAN, ELENA, MS.
To: EDWARDS LIFESCIENCES CORPORATION
Reel/Frame 051659/0649 →
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 20200093595A1 · Mar 26, 2020