Prosthetic heart valve

• US 10,729,543 B2
• Filed: 12/06/2019
• Issued: 08/04/2020
• 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:
  US16/705,930
• Publication Number:
  US 20200107929A1
• Time in Patent Office: 242 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 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 comprises;

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 the expanded configuration, and 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 twelve generally hexagonal openings at the inflow end portion of the frame and an outflow ring of twelve 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

a leaflet structure positioned within the frame and secured to leaflet attachment portions of the frame, the leaflet structure comprising a plurality of leaflets, each leaflet comprising a leaflet body, a free outflow edge, two opposing upper tabs, two opposing lower tabs, two notches between the upper tabs and the lower tabs, and an inflow edge portion extending between the lower tabs and including a lower apex;

wherein the plurality of leaflets are secured to one another at their adjacent sides to form commissures of the leaflet structure; and

wherein a first portion of each upper tab is folded against the respective leaflet in a first plane and a second portion of the each upper tab is folded in a second plane different than the first plane

wherein the prosthetic heart valve further comprises an inner skirt positioned primarily inside the frame and an outer skirt positioned primarily outside 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;

wherein the prosthetic heart valve further comprises reinforcing strips positioned between the inflow edge portions of the leaflets and the inner skirt,

wherein the outer skirt comprises a first lateral edge, a second lateral edge, an inflow edge extending between inflow ends of the first and second lateral edges of the outer skirt, and an outflow portion extending between outflow ends of the first and second lateral edges of the outer skirt, wherein the outflow portion comprises a plurality of alternating projections and notches, and wherein the first and second lateral edges of the outer skirt are coupled together such that the outer skirt forms an annular shape.

2. The valve of claim 1, wherein each leaflet further comprises an upper apex along the free outflow edge.

3. The valve of claim 1, wherein the second portion of each upper tab is sutured to a respective lower tab.

4. The valve of claim 1, wherein the upper tabs are positioned inside of the frame.

5. The valve of claim 1, wherein the first portion of each upper tab pivots about an axially extending crease and lays flat against the second portion of the upper tab when the valve is collapsed to the radially collapsed configuration.

6. The valve of claim 1, wherein the first portion of each upper tab extends radially inwardly from the frame and comprises an inner edge spaced radially from an inner surface of the frame, and the body portion of each leaflet articulates about the inner edges of the upper tabs in response to blood flowing through the valve when the valve is in operation within a patient'"'"'s body.

7. The valve of claim 1, wherein the leaflet attachment portions comprises rectangular portions of the frame, each comprising an enclosed opening between first and second axially oriented side struts, and wherein each lower tab extends radially outwardly through a respective enclosed opening to a location outside of the frame and is sutured to a respective upper tab to secure the leaflets to the side struts.

8. The valve of claim 1, wherein the outflow ring includes the leaflet attachment portions of the frame in addition to the generally hexagonal openings of the outflow ring.

9. The valve of claim 1, wherein the axially extending struts are thinner than the U-shaped crown structures of the first and second rows.

10. The valve of claim 1, wherein the plurality of axially extending struts constitute a row of axial struts that is less dense than first and second rows of angled struts.

11. The valve of claim 1, wherein the inflow end portion of the frame comprises a frame thickness (T1) that is less than a frame thickness (T2) of an intermediate portion of the frame.

12. The valve of claim 1, wherein the U-shaped crown structures joining adjacent ends of struts of the second row of angled struts are inverted relative to the U-shaped crown structures joining adjacent ends of struts of the first row of angled struts.

13. The valve of claim 1, 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.