Prosthetic heart valve

• US 10,433,959 B2
• Filed: 11/28/2018
• 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:
  US16/202,701
• Publication Number:
  US 20190192289A1
• Time in Patent Office: 314 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 heart 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, 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 comprises an inflow ring of honeycomb shaped hexagonal openings at the inflow end portion of the frame and en outflow ring of honeycomb shaped hexagonal openings at the outflow end of the frame, the outflow ring of honeycomb shaped hexagonal openings being a closest ring of openings to the outflow end of the frame;

wherein the entire frame has a generally cylindrical shape;

wherein the hexagonal 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 (Wangled struts arranged end-to-end, and a plurality of axially extending struts interconnecting the first and second rows of angled struts; and

wherein the 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.

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

3. 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.

4. The valve of claim 3, wherein row of axial struts includes fewer struts than the first and second rows of angled struts.

5. The valve of claim 1, wherein inflow ring has 12 hexagonal openings.

6. 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.

7. The valve of claim 1, wherein the hexagonal openings of the outflow ring are larger than the hexagonal openings of the inflow ring.

8. The valve of claim 1, wherein the outflow ring further comprises three rectangular openings that receive commissures of a leaflet valve structure.

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

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

11. An assembly comprising:

a delivery catheter having an inflatable balloon; and

an implantable prosthetic heart valve mounted on the delivery catheter, wherein the prosthetic heart valve is radially collapsible to a collapsed configuration and balloon expandable to an expanded configuration, the prosthetic heart valve comprising a radially expandable annular frame comprising 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 comprises an inflow ring of honeycomb shaped hexagonal openings at the inflow end portion of the frame and an outflow ring of honeycomb shaped hexagonal openings at the outflow end of the frame, the outflow ring of honeycomb shaped hexagonal openings being a closest ring of openings to the outflow end of the frame;

wherein the entire frame has a generally cylindrical shape;

wherein the hexagonal 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 the 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.

12. The assembly of claim 11, wherein the axially extending struts are thinner than the U-shaped crown structures of the first and second rows.

13. The assembly of claim 11, 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.

14. The assembly of claim 13, wherein row of axial struts includes fewer struts than the first and second rows of angled struts.

15. The assembly of claim 11, 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.

16. The assembly of claim 11, wherein the hexagonal openings of the outflow ring are larger than the hexagonal openings of the inflow ring.

17. The assembly of claim 11, further comprising at least one intermediate ring of openings between the inflow ring and the outflow ring.

18. The assembly of claim 11, wherein the openings of the outflow ring are larger than the openings of the at least one intermediate ring.