Prosthetic heart valve

• US 10,433,958 B2
• Filed: 11/27/2018
• Issued: 10/08/2019
• 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:
  US16/201,800
• Publication Number:
  US 20190192288A1
• Time in Patent Office: 315 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 heart valve comprising:

a radially expandable annular frame comprising plastically deformable material selected from group comprising stainless steel and 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,

wherein the frame comprises an outflow end portion defining an outflow end of the frame opposite the inflow end of the frame;

wherein the frame comprises an inflow ring of hexagonal openings at the inflow end portion of the frame;

wherein the frame comprises an outflow ring of hexagonal openings at the outflow end portion of the frame, the outflow ring of hexagonal openings being a closest ring of openings to the outflow end of the frame;

wherein the hexagonal openings of the outflow ring are larger than the hexagonal openings of the inflow ring; and

wherein the outflow ring and the inflow ring have an equal circumference.

2. The valve of claim 1, wherein the hexagonal openings of the outflow ring have a greater axial dimension than the hexagonal openings of the inflow ring.

3. The valve of claim 1, wherein the hexagonal openings of the outflow ring and the hexagonal openings of the inflow ring have an equal circumferential dimension.

4. The valve of claim 1, wherein the inflow ring and the outflow ring have an equal number of hexagonal openings.

5. The valve of claim 1, wherein inflow ring and the outflow each have 12 hexagonal openings.

6. The valve of claim 1, wherein the inflow ring of hexagonal openings is formed by a circumferentially extending lower row of angled struts arranged end-to-end and a circumferentially extending first intermediate row of angled struts arranged end-to-end, the lower and first intermediate rows of angled struts interconnected by a lower plurality of axially extending struts;

and

wherein the outflow ring of hexagonal openings is formed by a circumferentially extending upper row of angled struts arranged end-to-end and a circumferentially extending second intermediate row of angled struts arranged end-to-end, the upper and second intermediate rows of angled struts interconnected by an upper plurality of axially extending struts.

7. The valve of claim 6, wherein the upper plurality of axially extending struts are longer than the lower plurality of axially extending struts.

8. The valve of claim 1, further comprising at least one intermediate ring of openings between the inflow ring and the outflow ring.

9. The valve of claim 8, wherein the hexagonal openings of the outflow ring are larger than the openings of the at least one intermediate ring.

10. A prosthetic heart valve comprising a tubular frame made of a plastically deformable material selected from group comprising stainless steel and cobalt-chromium alloy, the prosthetic heart valve having a radially collapsed state and radially expanded state, the frame comprising:

an inflow ring of openings at an inflow end portion of the frame;

an outflow ring of openings at an outflow end portion of the frame; and

at least one intermediate ring of openings between the inflow ring of openings and outflow ring of openings;

wherein the inflow ring of openings is formed at an inflow end of the frame by a circumferentially extending lower row of angled struts arranged end-to-end and a circumferentially extending first intermediate row of angled struts arranged end-to-end, the lower and first intermediate rows of angled struts interconnected by a plurality of substantially straight, axially extending struts;

wherein the outflow ring of openings is formed at an outflow end of the frame by a circumferentially extending upper row of angled struts arranged end-to-end and a circumferentially extending second intermediate row of angled struts arranged end-to-end, the upper and second intermediate rows of angled struts interconnected by a plurality of straight, axially extending struts and a plurality of angularly spaced, axially extending commissure window frame portions, the outflow ring of hexagonal openings being a closest ring of openings to the outflow end of the frame;

wherein the inflow ring and the outflow ring have an equal number of hexagonal openings; and

wherein the outflow ring and the inflow ring have an equal circumference.

11. The valve of claim 10, wherein each axially extending strut and each commissure window frame portion of the outflow ring of openings extends from a location defined by the convergence of the lower ends of two adjacent angled struts of the upper row of angled struts to another location defined by the convergence of the upper ends of two adjacent angled struts of the second intermediate row of angled struts, and wherein each axially extending strut of the inflow ring of openings extends from a location defined by the convergence of the lower ends of two adjacent angled struts of the first intermediate row of angled struts to another location defined by the convergence of the upper ends of two adjacent angled struts of the lower row of angled struts.

12. The valve of claim 11, wherein the first intermediate row of angled struts is coupled to the second intermediate row of struts at a location defined by the convergence of the upper ends of two adjacent angled struts of the first intermediate row of angled struts and the second intermediate row of angled struts is coupled to the first intermediate row of angled struts at a location defined by the convergence of the lower ends of two adjacent angled struts of the second intermediate row of angled struts.

13. The valve of claim 10, wherein the openings of the outflow ring of openings are larger than the openings of both the inflow ring of openings and the at least one intermediate ring of openings.

14. The valve of claim 10, wherein adjacent angled struts of the frame form an angle of at least 110°

when the frame is in the radially expanded state.

15. The valve of claim 10, wherein the plurality of commissure window frame portions each comprise an enclosed opening between first and second axially oriented side struts.

16. The valve of claim 10, wherein the plurality of commissure window frame portions have an upper end and a lower end, wherein each upper and lower end of the plurality of commissure window frame portions is secured to the upper and lower rows of angled struts.

17. The valve of claim 10, wherein the lower ends of two adjacent angled struts of the rows of angled struts are connected by a junction with a U-shape and the upper ends of two adjacent angled struts of the rows of angled struts are connected by a junction with an inverted U-shape.

18. The valve of claim 10, wherein the openings of the outflow ring have a greater axial dimension than the openings of the inflow ring.

19. The valve of claim 10, wherein the openings of the outflow ring and the openings of the inflow ring have an equal circumferential dimension.

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 comprising a plastically deformable material selected from group comprising stainless steel and 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 the expanded configuration;

the frame also having an outflow end portion defining an outflow end of the frame opposite the inflow end of the frame;

wherein the frame comprises an inflow ring defining 12 hexagonal openings at the inflow end portion of the frame;

wherein the inflow ring is formed by a circumferentially extending lower row of angled struts arranged end-to-end, a circumferentially extending first intermediate row of angled struts arranged end-to-end, and a lower plurality of axially extending struts that interconnect the lower and first intermediate rows of angled struts;

wherein the frame further comprises an outflow ring defining 12 hexagonal openings and 3 leaflet attachment openings at the outflow end portion of the frame, the outflow ring being a closest ring of openings to the outflow end of the frame;

wherein the outflow ring is formed by a circumferentially extending upper row of angled struts arranged end-to-end, a circumferentially extending second intermediate row of angled struts arranged end-to-end, and an upper plurality of axially extending struts that interconnect the upper and second intermediate rows of angled struts;

wherein the frame further comprises an intermediate row of openings between the inflow ring and the outflow ring;

wherein the upper plurality of axially extending struts are longer than the lower plurality of axially extending struts, and the hexagonal openings of the outflow ring have a greater axial dimension than the hexagonal openings of the inflow ring; and

wherein the outflow ring and the inflow ring have an equal circumference.