Prosthetic heart valve

• US 10,537,423 B2
• Filed: 06/27/2016
• Issued: 01/21/2020
• Est. Priority Date: 10/05/2010
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Levi, Tamir S., Nguyen, Son V., Benichou, Netanel, Maimon, David, Yohanan, Ziv, Gurovich, Nikolay, Felsen, Bella, Dadonkina, Larisa, Sharoni, Ron, Sherman, Elena
• Primary Examiner(s): Scherbel, Todd J
• Application Number:
  US15/194,375
• Publication Number:
  US 20160374802A1
• Time in Patent Office: 1,303 Days
• CPC Class Codes: A61F 2/2412 with soft flexible valve members, e.g. tissue valves shaped like natural valves check valves with flexible valve members in general F16K15/14
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2433 using balloon catheter
• CPC Class Codes: A61F 2220/0075 sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2250/0036 differing in thickness
• CPC Class Codes: A61F 2250/0069 Sealing means
• CPC Class Codes: A61F 2250/0097 Visible markings, e.g. indicia

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

1. An implantable prosthetic valve that is radially collapsible to a collapsed configuration and radially expandable to an expanded configuration, the prosthetic valve comprising:

an annular frame;

a leaflet structure positioned within the frame;

an inner skirt positioned along an inner surface of the frame, the inner skirt being secured to the inside of the frame;

wherein the inner skirt comprises a weave of a first set of strands with a second set of strands, both the first and second sets of strands being non-parallel with an axial direction of the valve;

wherein when the valve is collapsed from the expanded configuration to the collapsed configuration, both the first and second sets of strands rotate toward the axial direction of the valve, allowing the inner skirt to elongate in the axial direction along with the frame; and

an outer fabric skirt extending from an inflow end of the frame along an outer surface of the frame, wherein the outer fabric skirt comprises an outflow edge defining a plurality of alternating projections and notches, wherein the projections project further toward an outflow end of the frame relative to the notches, the outflow edge is attached to the frame at the projections, and the outflow edge is free from the frame at the notches.

2. The valve of claim 1, wherein the first set of strands is substantially perpendicular to the second set of strands when the valve is in the expanded configuration.

3. The valve of claim 1, wherein the first set of strands forms a first angle with the axial direction of the valve and the second set of strands forms a second angle with the axial direction of the valve, the first and second angles being substantially equal.

4. The valve of claim 1, wherein the first and second sets of strands comprise 20-denier yarn.

5. The valve of claim 1, wherein an outer diameter of an inflow end portion of the frame is smaller than an outer diameter of an outflow end portion of the frame.

6. The valve of claim 1, wherein the leaflet structure comprises a plurality of leaflets, wherein each of the leaflets comprises:

opposing side tabs on opposite sides of the leaflet, the side tabs being secured to an outflow end portion of the frame;

a free outflow edge portion extending between the side tabs adjacent to an outflow end of the frame; and

an inflow edge portion extending between the side tabs adjacent to an inflow end of the frame, the inflow edge portion comprising opposing axial edge portions that extend from the side tabs toward the inflow end in a generally axial direction and an intermediate edge portion that extends between the axial edge portions, the intermediate edge portion comprising a curved apex portion adjacent to the inflow end of the frame and a pair of oblique portions that extend between the axial edge portions and the apex portion, the oblique portions having a greater radius of curvature than the apex portion.

7. The valve of claim 1, wherein the frame comprises three angularly spaced commissure windows each comprising an enclosed opening between first and second axially oriented side struts;

and the leaflet structure comprises a plurality of leaflets each comprising two opposing side tabs, each side tab being paired with an adjacent side tab of an adjacent leaflet to form commissures of the leaflet structure, and wherein each commissure extends radially outwardly through a corresponding commissure window of the frame to a location outside of the frame and is sutured to the side struts of the commissure window.

8. The valve of claim 7, wherein the commissure windows of the frame are depressed radially inwardly relative to the portions of the frame extending between adjacent commissure windows when the prosthetic valve is in the radially collapsed configuration.

9. The valve of claim 1, wherein the frame comprises an inflow row of openings at an inflow end portion of the frame, an outflow row of openings at an outflow end portion of the frame, and at least one intermediate row of openings between the inflow row of openings and outflow row of openings;

and wherein openings of the inflow row of openings are larger than openings of the at least one intermediate row of openings.

10. The valve of claim 1, wherein the frame has a plurality of openings and portions of the leaflet structure protrude through the openings while the prosthetic valve is in the radially collapsed configuration.

11. An implantable prosthetic valve that is radially collapsible to a collapsed configuration and radially expandable to an expanded configuration, the prosthetic heart valve comprising:

a radially expandable annular 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 the 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;

an inner fabric skirt positioned along an inner surface of the frame; and

an outer fabric skirt extending from the inflow end of the frame along an outer surface of the frame, wherein the outer fabric skirt comprises an outflow edge defining a plurality of alternating projections and notches, the projections projecting further toward the outflow end of the frame relative to the notches, the outflow edge is attached to the frame at the projections, and the outflow edge is free from the frame at the notches.

12. The valve of claim 11, wherein the outer fabric skirt extends from the inflow end of the frame along the outer surface of the frame to a plurality of outer skirt attachment locations on the outer surface of the frame, and wherein distances from the inflow end of the frame to the plurality of outer skirt attachment locations become smaller when the prosthetic heart valve is radially expanded.

13. The valve of claim 11, 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.

14. The valve of claim 11, wherein the leaflet structure comprises a plurality of leaflets, wherein each of the leaflets comprises:

opposing side tabs on opposite sides of the leaflet, the side tabs being secured to the outflow end portion of the frame;

a free outflow edge portion extending between the side tabs adjacent to the outflow end of the frame; and

an inflow edge portion extending between the side tabs adjacent to the inflow end of the frame, the inflow edge portion comprising opposing axial edge portions that extend from the side tabs toward the inflow end of the frame in a generally axial direction and an intermediate edge portion that extends between the axial edge portions, the intermediate edge portion comprising a curved apex portion adjacent to the inflow end of the frame and a pair of oblique portions that extend between the axial edge portions and the apex portion, the oblique portions having a greater radius of curvature than the apex portion.

15. The valve of claim 11, wherein the frame comprises three angularly spaced commissure windows each comprising an enclosed opening between first and second axially oriented side struts;

and

the leaflet structure comprises a plurality of leaflets each comprising two opposing side tabs, each side tab being paired with an adjacent side tab of an adjacent leaflet to form commissures of the leaflet structure, and wherein each commissure extends radially outwardly through a corresponding commissure window of the frame to a location outside of the frame and is sutured to the side struts of the commissure window.

16. The valve of claim 15, wherein the commissure windows of the frame are depressed radially inwardly relative to the portions of the frame extending between adjacent commissure windows when the prosthetic valve is in the collapsed configuration on the shaft.

17. The valve of claim 11, wherein the frame comprises an inflow row of openings at the inflow end portion of the frame, an outflow row of openings at the outflow end portion of the frame, and at least one intermediate row of openings between the inflow row of openings and outflow row of openings;

wherein openings of the inflow row of openings are larger than openings of the at least one intermediate row of openings.

18. The valve of claim 11, wherein the frame has a plurality of openings and portions of the leaflet structure protrude through the openings while the prosthetic valve is in the radially collapsed configuration.

19. The valve of claim 11, 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 between the inflow end portion and the outflow end portion.

20. An implantable prosthetic valve that is radially collapsible to a collapsed configuration and radially expandable to an expanded configuration, the prosthetic heart valve comprising:

a radially expandable annular 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 the 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;

an inner fabric skirt positioned along an inner surface of the frame; and

an outer fabric skirt extending from the inflow end of the frame along an outer surface of the frame, wherein the outer fabric skirt comprises an outflow edge defining a plurality of alternating projections and notches, the outflow edge being attached to the frame;

wherein the frame comprises an inflow row of openings at the inflow end portion of the frame, an outflow row of openings at the outflow end portion of the frame, and at least one intermediate row of openings between the inflow row of openings and outflow row of openings; and

wherein openings of the inflow row of openings are larger than openings of the at least one intermediate row of openings.