Prosthetic heart valve

Patent metadata

Field	Value
Publication number	US-12318283-B2
Application number	US-202017105267-A
Country	US
Kind code	B2
Filing date	Nov 25, 2020
Priority date	Oct 5, 2010
Publication date	Jun 3, 2025
Grant date	Jun 3, 2025

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.

First claim

The invention claimed is:

1. An assembly comprising:
a delivery apparatus comprising a shaft and a balloon on the shaft; and
a prosthetic heart valve mounted on the balloon on the shaft in a radially collapsed configuration;
wherein the prosthetic heart valve is radially collapsed to the radially collapsed configuration for delivery into a patient and is radially expandable to a radially expanded configuration for implantation in the patient by inflation of the balloon;
wherein the prosthetic heart valve comprises:
an annular frame that is radially collapsed and is radially expandable, the frame comprising an inflow end portion defining an inflow end of the frame, the inflow end of the frame being configured to receive antegrade blood flow into the prosthetic heart valve when the prosthetic heart valve is implanted in the patient in the radially expanded configuration, the frame also comprises an outflow end portion defining an outflow end of the frame opposite the inflow end of the frame, wherein the frame further comprises an inflow ring of openings in the inflow end portion of the frame, an outflow ring of openings in the outflow end portion of the frame, and one or more intermediate rings of openings between the inflow ring and the outflow ring, and wherein the openings of the inflow ring of openings are relatively larger than the openings of the one or more intermediate rings of openings;
a leaflet structure comprising a lower, inflow edge and an upper, coaptation edge, wherein both the lower, inflow edge and the upper, coaptation edge are positioned within the frame between the inflow end of the frame and the outflow end of the frame; and
an outer fabric skirt extending from the inflow end of the frame along an outer surface of the inflow end portion of the frame;

wherein 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 when the prosthetic heart valve is in the radially collapsed configuration mounted on the balloon; and
wherein both the inflow end portion of the frame and the outflow end portion of the frame are radially expanded by inflation of the balloon.

2. The assembly of claim 1 , 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 the outer fabric skirt around the inflow end portion of the frame when the prosthetic heart valve is in the radially collapsed configuration mounted on the balloon.

3. The assembly of claim 2 , 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 and the outer diameter of the inflow end portion of the frame, is less than or equal to the outer diameter of the outflow end of the frame.

4. The assembly of claim 1 , wherein the openings of the outflow ring of openings are larger than the openings of the one or more intermediate rings of openings.

5. The assembly of claim 1 , wherein the inflow ring of openings comprises 12 hexagonal openings.

6. The assembly of claim 1 , 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.

7. The assembly of claim 1 , wherein the inflow end portion of the frame comprises a frame thickness that is less than a frame thickness of an intermediate portion of the frame.

8. The assembly of claim 1 , wherein the inflow end portion of the frame comprises a frame thickness that is less than a frame thickness of the outflow end portion of the frame.

9. An annular frame for a prosthetic heart valve, the frame being radially collapsible and radially expandable and comprising an inflow end portion defining an inflow end of the frame that is configured to receive antegrade blood flow into the frame when implanted within a patient's body in a radially expanded configuration, and the frame also comprising an outflow end portion defining an outflow end of the frame opposite the inflow end of the frame;
wherein the frame is configured to have coaptation edges and inflow edges of a leaflet structure mounted inside of the frame between the inflow end and the outflow end of the frame, and is configured to have an outer fabric skirt extending around an outer surface of the inflow end portion of the frame;
wherein the frame has a radially collapsed configuration while mounted on a balloon for delivery into the patient's body, and 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;
wherein both the inflow end portion of the frame and the outflow end portion of the frame are configured to be radially expanded by inflation of the balloon;
wherein the frame further comprises an inflow ring of openings in the inflow end portion of the frame, an outflow ring of openings in the outflow end portion of the frame, and one or more intermediate rings of openings between the inflow ring and the outflow ring; and
wherein the openings of the inflow ring of openings are relatively larger than the openings of the one or more intermediate rings of openings.

10. The frame of claim 9 , 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 the outer fabric skirt to be positioned around the inflow end portion of the frame when the frame is in the radially collapsed configuration for delivery into the patient.

11. The frame of claim 9 , wherein the openings of the outflow ring of openings are larger than the openings of the one or more intermediate rings of openings.

12. The frame of claim 9 , wherein the inflow ring of openings comprises 12 hexagonal openings.

13. The frame of claim 9 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.

14. The frame of claim 9 , wherein the inflow end portion of the frame comprises a frame thickness that is less than a frame thickness of an intermediate portion of the frame.

15. The frame of claim 9 , wherein the inflow end portion of the frame comprises a frame thickness that is less than a frame thickness of the outflow end portion of the frame.

16. An annular frame for a prosthetic heart valve, the frame being radially collapsible and radially expandable and comprising an inflow end portion defining an inflow end of the frame that is configured to receive antegrade blood flow into the frame when implanted within a patient's body in a radially expanded configuration, and the frame also comprising an outflow end portion defining an outflow end of the frame opposite the inflow end of the frame;
wherein the frame is configured to have inflow edges and coaptation edges of a leaflet structure mounted inside of the frame between the inflow end and the outflow end of the frame, and is configured to have an outer fabric skirt extending around an outer surface of the inflow end portion of the frame;
wherein the frame has a radially collapsed configuration while mounted on a balloon for delivery into the patient's body, and 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;
wherein both the inflow end portion o

Assignees

• Edwards Lifesciences Corp

Inventors

• Levi Tamir S
• Nguyen Son V
• Benichou Netanel
• Maimon David
• Yohanan Ziv
• Gurovich Nikolai
• Felsen Bella
• Dadonkina Larisa
• Sharoni Ron
• Sherman Elena

Classifications

• A61F2/2412

  with soft flexible valve members, e.g. tissue valves shaped like natural valves · CPC title

• A61F2250/0036

  differing in thickness · CPC title

• A61F2230/0054

  V-shaped · CPC title

• A61F2250/0097

  Visible markings, e.g. indicia · CPC title

• A61F2220/0075

  sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable · CPC title