Mechanically expandable heart valve

Patent metadata

Field	Value
Publication number	US-12201522-B2
Application number	US-202318207822-A
Country	US
Kind code	B2
Filing date	Jun 9, 2023
Priority date	Jun 5, 2017
Publication date	Jan 21, 2025
Grant date	Jan 21, 2025

Abstract

In one embodiment, a method of assembling a prosthetic valve can comprise forming a radially expandable and compressible frame by pivotally joining together a plurality of struts without requiring individual rivets. In some embodiments, the frame is formed by interweaving the struts, which can be joined using integral hinges formed in the struts, such as by performing alternate cuts on the struts, bending the struts to form stopper tabs adjacent to joints and/or drilling holes in the struts to facilitate interconnecting struts at joints, or otherwise forming integral hinges and corresponding holes at junction points between the struts. In other embodiments, separate hinges are provided to interconnect the struts. In still other embodiments, separate flanged rivets are provided to connect the struts.

First claim

What is claimed is:

1. A mechanically expandable prosthetic heart valve frame assembly, comprising:
a first set of a plurality of first struts extending in a first direction; and
a second set of a plurality of second struts extending in a second direction;
wherein the first struts are interwoven with the second struts to form an annular frame that is radially compressible and expandable; and

a valve member comprising a plurality of leaflets mounted inside the annular frame;
wherein each first strut:
is pivotally connected to a plurality of second struts, and
comprises a plurality of projections spaced apart from each other along a length of the first strut, wherein the projections are integrally formed on the first strut;

wherein each second strut comprises a plurality of apertures extending along a length of the second strut;
wherein the plurality of projections of the first struts extend into respective apertures of the second struts; and
wherein the annular frame is configured such that rotation of the second set of struts around the integrally formed projections permits radial expansion of the frame.

2. The mechanically expandable prosthetic heart valve frame assembly of claim 1 , wherein each first strut has at least one projection that extends radially inwardly and into an aperture of an adjacent second strut and at least one projection that extends radially outwardly and into an aperture of an adjacent second strut.

3. The mechanically expandable prosthetic heart valve frame assembly of claim 2 , wherein each first strut has at least two projections that extend radially inwardly and into respective apertures of adjacent second struts.

4. The mechanically expandable prosthetic heart valve frame assembly of claim 3 , wherein each first strut has at least two projections that extend radially outwardly and into respective apertures of adjacent second struts.

5. The mechanically expandable prosthetic heart valve frame assembly of claim 2 , wherein each first strut has at least two projections that extend radially outwardly and into respective apertures of adjacent second struts.

6. The mechanically expandable prosthetic heart valve frame assembly of claim 1 , further comprising one or more actuators mounted on the frame and configured to radially expand and compress the frame between a radially compressed state defining a compressed diameter and a radially expanded state defining an expanded diameter.

7. The mechanically expandable prosthetic heart valve frame assembly of claim 6 , wherein the plurality of apertures comprises a plurality of non-circular apertures, and further wherein the plurality of projections comprises a plurality of non-circular projections.

8. The mechanically expandable prosthetic heart valve frame assembly of claim 7 , wherein the plurality of non-circular projections are configured to be rotationally offset from the second struts at the compressed diameter, the expanded diameter, and all diameters in between the compressed and expanded diameters.

9. The mechanically expandable prosthetic heart valve frame assembly of claim 8 , wherein the plurality of non-circular projections are configured to prevent radial separation of the first and second struts when rotationally offset from the corresponding non-circular apertures.

10. A mechanically expandable prosthetic heart valve frame assembly, comprising:
a radially expandable and compressible annular frame comprising a plurality of interconnected struts, the plurality of struts comprising a first set of a plurality of first struts and a second set of a plurality of second struts;
wherein the first struts overlap adjacent second struts at junctions, and wherein expansion or compression of the annular frame causes the first struts to pivot relative to the second struts at the junctions; and

a valve member comprising a plurality of leaflets mounted inside the annular frame;
wherein the annular frame comprises a plurality of hinges at the junctions extending from the plurality of first struts through corresponding non-circular apertures of the plurality of second struts at the junctions;
wherein each hinge comprises a locking member configured to extend through one of the corresponding non-circular apertures; and
wherein the second struts are formed with recessed portions surrounding the non-circular apertures and the locking members of the hinges are disposed within the recessed portions.

11. The mechanically expandable prosthetic heart valve frame assembly of claim 10 , further comprising one or more actuators mounted on the annular frame and configured to radially expand and compress the annular frame between a radially compressed state defining a compressed diameter and a radially expanded state defining an expanded diameter.

12. The mechanically expandable prosthetic heart valve frame assembly of claim 11 , wherein the locking members are rotationally offset from corresponding non-circular apertures in struts from the second set of struts at the compressed diameter, the expanded diameter, and all diameters in between the compressed and expanded diameters.

13. The mechanically expandable prosthetic heart valve frame assembly of claim 12 , wherein the hinges are integrally formed on the plurality of first struts.

14. The mechanically expandable prosthetic heart valve frame assembly of claim 12 , wherein:
the hinges are separate components from the plurality of first struts and the plurality of second struts;
each of the plurality of first struts comprises a plurality of non-circular apertures; and
each hinge extends through an aperture in a first strut of the plurality of first struts and an adjacent aperture in a second strut of the plurality of second struts at a junction.

15. The mechanically expandable prosthetic heart valve frame assembly of claim 14 , wherein each of the hinges further comprises a retaining member configured to be retained within the non-circular apertures on the first struts.

16. The mechanically expandable prosthetic heart valve frame assembly of claim 15 , wherein each of the hinges further comprises a circular base member configured to be retained within a circular recess surrounding one of the non-circular apertures on the first struts.

17. The mechanically expandable prosthetic heart valve frame assembly of claim 10 , wherein the locking members comprise a non-circular shape.

18. The mechanically expandable prosthetic heart valve frame assembly of claim 10 , wherein the locking members comprise a non-circular central protrusion with at least two ears extending outward therefrom in a plane parallel to the strut.

19. A mechanically expandable prosthetic heart valve frame assembly, comprising:
a first set of a plurality of first struts extending in a first direction; and
a second set of a plurality of second struts extending in a second direction;
wherein the first struts and the second struts form an annular frame that is radially compressible and expandable;

a valve member comprising a plurality of leaflets mounted inside the annular frame; and
one or more actuators mounted on the frame and configured to radially expand and compress the frame between a radially compressed state defining a compressed diameter and a radially expanded state defining an expanded diameter;
wherein each first strut:
is pivotally connected to a plurality of second struts, and
comprises a plurality of non-circular projections spaced apart from each other along a length of the first strut;

wherein each second strut comprises a plu

Assignees

• Edwards Lifesciences Corp

Inventors

• Barash Alexander
• Neumann Yair A
• Saar Tomer
• Yohanan Ziv
• Nir Noam

Classifications

• A61F2/9517

  handle assemblies therefor · CPC title

• A61F2/2436

  Deployment by retracting a sheath · CPC title

• A61F2/844

  folded prior to deployment · CPC title

• A61F2/2439

  Expansion controlled by filaments · CPC title

• A61F2002/9511

  the retaining means being filaments or wires · CPC title