Granted Patent B2

US 12,661,222 · App. 18/096,511 · Granted Jun 23, 2026

Inventor: Noam Nir (Pardes-Hanna, IL)

Assignee: Edwards Lifesciences Corporation

A61F2/2418A61F2/2436A61F2210/0014

Abstract

Claims (59)

1 . A prosthetic valve, comprising:

a frame having an inflow end and an outflow end, wherein the frame is movable between a radially compressed and a radially expanded state;

at least one expansion and locking mechanism, comprising:

a guide member, coupled to the frame at a first location, and comprising:

a guide member first surface,

a guide member second surface, and

two guide member through-holes extending between the guide member first surface and the guide member second surface;

a base member, coupled to the frame at a second location spaced apart from the first location, and comprising:

a base member first surface,

a base member second surface, and

two base member through-holes extending between the base member first surface and the base member second surface; and

a wire comprising:

a wire base end portion looped over the base member second surface, and

two wire axial portions extending from the base member second surface, through the base member through-holes, toward and through the guide member through-holes;

wherein movement of the base member in a first direction, relative to the guide member, causes the frame to foreshorten axially and expand radially;

wherein each wire axial portion defines an axial lock portion at a region that extends beyond the guide member first surface; and

wherein the axial lock portions are configured to form together a twist disposed over the guide member first surface when they are intertwined together, such that when the twist is formed, it is configured to prevent, along with the wire base end portion, recompression of the frame.

2 . The prosthetic valve of claim 1 , wherein the wire defines a closed loop, such that both wire axial portions are joined by a pull end portion, opposite to the wire base end portion.

3 . The prosthetic valve of claim 1 , further comprising the twist formed by the axial lock portions intertwined with each other.

4 . A delivery assembly, comprising:

a prosthetic valve comprising:

a frame having an inflow end and an outflow end, wherein the frame is movable between a radially compressed and a radially expanded state;

at least one expansion and locking mechanism, comprising:

a guide member coupled to the frame at a first location, the guide member defined between a guide member first surface and a guide member second surface;

a base member, coupled to the frame at a second location spaced apart from the first location; and

a wire comprising:

a wire base end portion looped over the base member, and

two wire axial portions extending from the wire base end portion, through the base member, toward and through guide member;

a delivery apparatus comprising:

a handle;

a delivery shaft extending distally from the handle; and

at least one actuation assembly extending from the handle through the delivery shaft, the actuation assembly comprising a sleeve, the sleeve comprising:

a sleeve outer surface;

a sleeve distal end;

at least one sleeve distal opening; and

at least one sleeve channel extending from the at least one sleeve distal opening;

wherein the sleeve is configured to accommodate a portion of the wire within the at least one sleeve channel, such that the portion of the wire accommodated within the sleeve is axially movable with respect to the sleeve;

wherein movement of the base member in a first direction, relative to the guide member, causes the frame to foreshorten axially and expand radially;

wherein the wire axial portions define axial lock portions at a region that extends beyond the guide member first surface; and

wherein rotation of the sleeve is configured to intertwine the wire axial portions so as to form a twist disposed over the guide member first surface, such that when the twist is formed, it is configured to prevent, along with the wire base end portion, recompression of the frame.

5 . The delivery assembly of claim 4 , wherein the at least one sleeve distal opening comprises two sleeve distal openings, and wherein the at least one sleeve channel comprises two sleeve channels.

6 . The delivery assembly of claim 5 , wherein the sleeve further comprises two sleeve side openings defined at the sleeve outer surface, such that each sleeve channel extends between a corresponding sleeve distal opening and a corresponding sleeve side opening.

7 . The delivery assembly of claim 6 , wherein each wire axial portion extends into a corresponding sleeve channel through the corresponding sleeve distal opening, and exits the sleeve channel through the corresponding sleeve side opening.

8 . The delivery assembly of claim 6 , wherein each actuation assembly further comprises a cutting shaft extending concentrically over the sleeve, and movable axially relative thereto, the cutting shaft comprising a blade.

9 . The delivery assembly of claim 5 , wherein the sleeve channels extend axially along a length of the sleeve.

10 . The delivery assembly of claim 9 , wherein each wire axial extension comprises an eyelet, and wherein each actuation assembly further comprises two pull members, each pull member looped through the eyelet such that two strands thereof extend proximally from the eyelet.

11 . The delivery assembly of claim 4 , wherein the wire defines a closed loop, such that both wire axial portions are joined by a pull end portion, opposite to the wire base end portion.

12 . The delivery assembly of claim 11 , wherein the actuation assembly further comprises a pull member attached to a quick release hook, configured to transition between a closed configuration and an open configuration.

13 . The delivery assembly of claim 11 , wherein the actuation assembly further comprises a pull member looped through the pull end portion such that two strands of the pull member extend proximally from the pull end portion.

14 . The delivery assembly of claim 11 , wherein the actuation assembly further comprises a pull member having a bendable distal portion made of a shape-memory material and configured to transition between a biased configuration, in which the bendable distal portion is bent over itself, and an unbiased configuration, and wherein the pull end portion is releasably attached to the bendable distal portion in its biased configuration.

15 . The prosthetic valve of claim 4 , wherein the prosthetic valve further comprises the twist formed by the axial lock portions intertwined with each other.

16 . A method for expanding and locking a prosthetic valve, comprising the steps of:

providing a delivery assembly comprising a delivery apparatus releasably coupled to a prosthetic valve, wherein the delivery apparatus comprises a handle and at least one actuation assembly extending therefrom, each actuation assembly comprising a sleeve with at least one sleeve channel, and wherein the prosthetic valve comprises a frame and at least one expansion and locking assembly, each expansion and locking assembly comprising a guide member coupled to the frame at a first location, a base member coupled to the frame at a second location which is axially spaced from the first location, and a wire having a wire base end portion looped over a surface of the base member, and two wire axial portions extending from the wire base end portion, through the base member, toward and through the guide member;

approximating the sleeve to the guide member such that a distal end thereof contacts the guide member;

utilizing the actuation assembly and the wire to approximate the base member and the guide member toward each other, thereby expanding the frame; and

rotating the sleeve around its axis of symmetry, so as to intertwine axial lock portions of the wire axial portions over each other, thereby forming a twist disposed over the guide member.

17 . The method of claim 16 , further comprising a step of pulling the sleeve away from the guide member, thereby exposing the axial lock portions extending between the guide member and a distal end of the sleeve.

18 . The method of claim 17 , wherein the sleeve comprises a threaded proximal portion, wherein the step of pulling the sleeve away from the guide member is performed by threading the threaded proximal portion so as to facilitate rotational movement of the sleeve around its axis of symmetry, simultaneous to the pulling of the sleeve away from the guide member, and wherein the rotational movement is configured to intertwine the axial lock portions over each other, thereby forming the twist disposed over the guide member.

19 . The method of claim 16 , wherein the wire axial portions extend into the sleeve channel, and are joined together via a pull end portion of the wire which is looped through a bendable distal portion of a pull member, wherein the bendable distal portion is retained in a biased configuration in which it is folded over itself within the sleeve channel, and wherein the method further comprises pulling the sleeve relative to the bendable distal portion, so as to expose the bendable distal portion and allowing it to transition to its unbiased configuration, thereby allowing the pull end portion of the wire to disengage therefrom.

Assignments (1)

Continuity (3)

References Cited (387)