Mechanically expanding heart valve and delivery apparatus therefor

Patent metadata

Field	Value
Publication number	US-11344408-B2
Application number	US-202016813637-A
Country	US
Kind code	B2
Filing date	Mar 9, 2020
Priority date	Dec 6, 2016
Publication date	May 31, 2022
Grant date	May 31, 2022

Abstract

An assembly can comprise a radially expandable and compressible annular frame, at least one linear actuator assembly coupled to the frame and at least one locking mechanism coupled to the frame. The linear actuator can be configured to apply a distally directed force and/or a proximally directed force to the frame to radially expand or compress the frame. The locking mechanism can comprise a first sleeve member connected to the frame at a first location, a second sleeve member having internal threads and being connected to the frame at a second location, and a first screw configured to engage the internal threads of the second sleeve member to retain the frame in a radially expanded state.

First claim

What is claimed is:

1. A prosthetic valve, comprising:
a radially expandable and compressible frame comprising a plurality of interconnected struts, each strut having a first end, a second end, and a length extending from the first end to the second end, each strut comprising a plurality of linear segments that are laterally offset from each other in a direction perpendicular to the lengths of the struts; and
a valvular structure mounted to the frame and configured to regulate the flow of blood through the prosthetic valve.

2. The prosthetic valve of claim 1 , wherein each of the plurality of struts is hingeably connected to at least another of the plurality of struts.

3. The prosthetic valve of claim 1 , further comprising a spacer disposed between a pair of connected struts.

4. The prosthetic valve of claim 1 , wherein the struts are connected to each other by pins extending through the struts.

5. The prosthetic valve of claim 4 , wherein each pin extends through overlapping apertures of two struts, wherein each aperture of the overlapping apertures is arranged in an intermediate segment of a respective strut, each intermediate segment arranged between adjacent linear segments of the respective strut.

6. The prosthetic valve of claim 5 , wherein a width of each intermediate segment is greater than a width of the adjacent linear segments, the widths arranged perpendicular to the length of the respective strut.

7. The prosthetic valve of claim 1 , wherein each linear segment is defined by two longitudinal edges of the linear segment with a central longitudinal axis arranged between the two longitudinal edges, wherein the central longitudinal axes of the plurality of linear segments of each strut are laterally offset from each other, and wherein a width of each linear segment of each strut varies along the length of the strut, the width arranged perpendicular to the length of the strut.

8. The prosthetic valve of claim 1 , wherein the frame comprises a plurality of circumferentially spaced locking units configured to lock the frame in a radially expanded state.

9. The prosthetic valve of claim 1 , further comprising at least one linear actuator assembly coupled to the frame and configured to radially expand the frame.

10. The prosthetic valve of claim 1 , further comprising an annular skirt secured to an outer surface of an inflow end portion of the plurality of interconnected struts.

11. The prosthetic valve of claim 1 , wherein the first end of each strut forms a first apex arranged at a first end of the frame and a second end of each strut forms a second apex arranged at an opposite, second end of the frame and wherein a width of the first end and the second end is greater than a width of each linear segment of the plurality of linear segments of each strut, the widths arranged perpendicular to the length of the strut.

12. A prosthetic valve, comprising:
a radially expandable and compressible annular frame comprising a plurality of interconnected struts, each strut having a first end portion arranged at an inflow end of the frame, a second end portion arranged at an outflow end of the frame, and a length extending from the first end to the second end, each strut comprising a plurality of linear segments that are laterally offset from each other in a direction perpendicular to the length of the strut and that are arranged end-to-end with adjacent ends interconnected to each other by intermediate segments of the strut; and
a valvular structure coupled to the frame and configured to regulate the flow of blood through the prosthetic valve.

13. The prosthetic valve of claim 12 , wherein each intermediate segment and each of the first end portion and second end portion of each strut includes a respective aperture adapted to receive a fastener, wherein each linear segment has a first width, and wherein each intermediate segment and each of the first end portion and the second end portion of each strut has a second width that is wider than the first width, the first width and second width arranged perpendicular to the length of the strut.

14. The prosthetic valve of claim 13 , wherein the plurality of struts are interconnected at a plurality of hinge joints and wherein each hinge joint of the plurality of hinge joints is formed by a fastener extending through apertures of overlapping intermediate segments of a pair of struts of the plurality of struts so that the pair of struts are hingeably connected to one another.

15. The prosthetic valve of claim 14 , wherein a spacer is disposed between the overlapping intermediate segments of the pair of struts.

16. The prosthetic valve of claim 12 , wherein the frame comprises a plurality of circumferentially spaced locking units configured to lock the frame in a radially expanded state and wherein each locking unit is secured to the frame via a fastener extending through an aperture formed in the locking unit and through corresponding apertures in corresponding, overlapping intermediate segments of struts of the plurality of interconnected struts.

17. A prosthetic valve, comprising:
an annular frame, radially expandable and compressible between a radially expanded state and a radially compressed state, the frame comprising a plurality of interconnected struts, each strut having a zig-zag pattern defined by a plurality of offset linear segments that have central longitudinal axes that are offset from one another in a direction perpendicular to a length of each strut, the central longitudinal axis of each linear segment defined between two longitudinal edges of the linear segment, the length of each strut defined between a first end portion that forms a portion of an apex at a first end of the frame and a second end portion that forms a portion of an apex at an opposite, second end of the frame, each linear segment of each strut arranged between one of the first end portion and the second end portion and an intermediate segment or between two adjacent intermediate segments; and
a valvular structure mounted to the frame and comprising a leaflet assembly.

18. The prosthetic valve of claim 17 , wherein the plurality of interconnected struts are hingeably coupled to each other at hinge joints formed by pins extending through overlapping apertures in the struts, the overlapping apertures arranged in overlapping intermediate segments.

19. The prosthetic valve of claim 18 , wherein a plurality of open cells are defined between the plurality of interconnected struts and wherein when the frame is in the radially compressed state, a gap is formed at a middle of each open cell, between two adjacent hinge joints.

20. The prosthetic valve of claim 17 , wherein a width of each linear segment of a strut of the plurality of struts varies along the length of the strut, the width arranged perpendicular to the length of the strut.

Assignees

• Edwards Lifesciences Corp

Inventors

• Maimon David
• Manash Boaz
• Leiba Eyal
• Yohanan Ziv
• Neumann Yair A
• Dvorsky Anatoly
• Bar-Or Jonathan
• Cohen Oren
• Witzman Ofir
• Tayeb Liron
• Schwarcz Elazar Levi
• Miller Noam
• Saar Tomer

Classifications

• A61F2250/0069

  Sealing means · CPC title

• A61F2250/001

  for adjusting a diameter · CPC title

• A61F2230/0091

  helically-coiled or spirally-coiled, i.e. having a 2-D spiral cross-section · CPC title

• A61F2220/0091

  connected by a hinged linkage mechanism, e.g. of the single-bar or multi-bar linkage type · CPC title

• A61F2220/0041

  using additional screws, bolts, dowels or rivets, e.g. connecting screws · CPC title