IP Library › Granted Patent US 12702548
Granted Patent B2
US 12702548 · App. 17/978,826 · Granted Aug 11, 2026

Leaflet attachment in prosthetic heart valves using buckle commissure clamps

Inventors: Noam Nir (Pardes-Hanna, IL); Michael Bukin (Pardes Hanna, IL)
Assignee: Edwards Lifesciences Corporation
A61F2/2418A61F2/2409A61F2002/30177A61F2220/0075A61F2250/0069
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Quick Facts
Patent No.
US 12702548
App. No.
17/978,826
Granted
Aug 11, 2026
Kind
B2
Abstract

A buckle commissure clamp can be used to attach leaflets of a valvular structure to a frame of a prosthetic heart valve. Tabs of adjacent leaflets can be assembled to the buckle commissure clamp by passing each leaflet through one or more gaps of the buckle commissure clamp. Each leaflet tab can be wrapped around portions of the buckle commissure clamp. Once the leaflet tabs are assembled to the buckle commissure clamp, the assembly can be attached to the frame, for example, by one or more sutures extending between the buckle commissure clamp and a support member, such as a strut of the frame, an actuator of the frame, a locking mechanism of the frame. In some embodiments, the buckle commissure clamp has a substantially W-shape or M-shape.

Claims (73)

1 . A prosthetic heart valve comprising:

a frame that is radially collapsible and expandable between a radially-compressed configuration and a radially-expanded configuration, the frame having an inflow end and an outflow end separated from the inflow end along an axial direction of the frame;

a plurality of buckle commissure clamps coupled to the frame, each buckle commissure clamp having one or more gaps; and

a valvular structure formed by a leaflet assembly, the leaflet assembly comprising a plurality of leaflets, each leaflet having a pair of tabs, each leaflet tab being coupled to a respective one of the buckle commissure clamps by being wrapped around at least a portion of the buckle commissure clamp,

wherein each buckle commissure clamp comprises first and second arms, first and second end portions, and first, second, and third bent portions,

the first and second arms are connected together by the third bent portion at a second end of the buckle commissure clamp,

the first and second arms and the third bent portion define a central gap therebetween that opens to a first end of the buckle commissure clamp,

the first end portion is connected to the first arm by the first bent portion,

the second end portion is connected to the second arm by the second bent portion,

the first end portion, the first arm, and the first bent portion define a first gap therebetween that opens to the second end of the buckle commissure clamp, and

the second end portion, the second arm, and the second bent portion define a second gap therebetween that opens to the second end of the buckle commissure clamp, and

wherein each buckle commissure clamp has a W-shape or M-shape in a view along a radial direction of the frame.

2 . The prosthetic heart valve of claim 1 , wherein

for each buckle commissure clamp, the respective first and second arms and the respective first and second end portions are substantially straight members.

3 . The prosthetic heart valve of claim 1 , wherein, for each buckle commissure clamp:

the respective first and second arms and the respective first and second end portions are substantially co-planar;

the respective first and second arms and the respective first and second end portions are substantially parallel to each other; or

the respective first and second arms and the respective first and second end portions are substantially co-planar and parallel to each other.

4 . A prosthetic heart valve comprising:

a frame that is radially collapsible and expandable between a radially-compressed configuration and a radially-expanded configuration, the frame having an inflow end and an outflow end separated from the inflow end along an axial direction of the frame;

a plurality of buckle commissure clamps coupled to the frame, each buckle commissure clamp having one or more gaps; and

a valvular structure formed by a leaflet assembly, the leaflet assembly comprising a plurality of leaflets, each leaflet having a pair of tabs, each leaflet tab being coupled to a respective one of the buckle commissure clamps by being wrapped around at least a portion of the buckle commissure clamp,

wherein each buckle commissure clamp comprises first and second arms, first and second end portions, and first, second, and third bent portions,

the first and second arms are connected together by the third bent portion at a second end of the buckle commissure clamp,

the first and second arms and the third bent portion define a central gap therebetween that opens to a first end of the buckle commissure clamp,

the first end portion is connected to the first arm by the first bent portion,

the second end portion is connected to the second arm by the second bent portion,

the first end portion, the first arm, and the first bent portion define a first gap therebetween that opens to the second end of the buckle commissure clamp, and

the second end portion, the second arm, and the second bent portion define a second gap therebetween that opens to the second end of the buckle commissure clamp, and

wherein, for each buckle commissure clamp, the respective first and second arms and the respective first and second end portions extend along respective directions parallel to the axial direction of the frame.

5 . The prosthetic heart valve of claim 1 , wherein, for each buckle commissure clamp, the respective first end is closer to the outflow end of the frame than the inflow end of the frame, and the respective second end is closer to the inflow end of the frame than the outflow end of the frame.

6 . The prosthetic heart valve of claim 1 , wherein, for each buckle commissure clamp, the respective first end is closer to the inflow end of the frame than the outflow end of the frame, and the respective second end is closer to the outflow end of the frame than the inflow end of the frame.

7 . The prosthetic heart valve of claim 1 , wherein each buckle commissure clamp is coupled to the frame via one or more sutures wrapped around the first bent portion, the second portion, the third bent portion, or any combination thereof.

8 . The prosthetic heart valve of claim 1 , wherein each leaflet tab is wrapped around multiple portions of the respective buckle commissure clamp.

9 . The prosthetic heart valve of claim 1 , wherein, for each buckle commissure clamp:

a first leaflet tab coupled to said buckle commissure clamp follows a serpentine path through the central gap from a first side of said buckle commissure clamp to a second side of said buckle commissure clamp, and then through the first gap from the second side of said buckle commissure clamp to the first side of said buckle commissure clamp to wrap around portions of the first arm and the first end portion; and

a second leaflet tab coupled to said buckle commissure clamp follows another serpentine path through the central gap from the first side of said buckle commissure clamp to the second side of said buckle commissure clamp, and then through the second gap from the second side of said buckle commissure clamp to the first side of said buckle commissure clamp to wrap around portions of the second arm and the second end portion.

10 . The prosthetic heart valve of claim 1 , wherein, for each buckle commissure clamp, ends of the first and second leaflet tabs are disposed between the respective buckle commissure clamp and the frame along a radial direction of the frame.

11 . The prosthetic heart valve of claim 1 , wherein each buckle commissure clamp is coupled to the frame by attachment to a respective support member that is part of or coupled to the frame.

12 . The prosthetic heart valve of claim 11 , wherein the support member comprises a portion of an actuator or a locking mechanism of the frame, or the support member is coupled to an actuator or locking mechanism of the frame.

13 . The prosthetic heart valve of claim 11 , wherein the support member comprises a strut or post integral with the frame.

14 . A prosthetic heart valve comprising:

a frame that is radially collapsible and expandable between a radially-compressed configuration and a radially-expanded configuration, the frame having an inflow end and an outflow end separated from the inflow end along an axial direction of the frame;

a plurality of buckle commissure clamps coupled to the frame, each buckle commissure clamp having one or more gaps; and

a valvular structure formed by a leaflet assembly, the leaflet assembly comprising a plurality of leaflets, each leaflet having a pair of tabs, each leaflet tab being coupled to a respective one of the buckle commissure clamps by being wrapped around at least a portion of the buckle commissure clamp,

wherein each buckle commissure clamp comprises first and second arms, first and second end portions, and first, second, and third bent portions,

the first and second arms are connected together by the third bent portion at a second end of the buckle commissure clamp,

the first and second arms and the third bent portion define a central gap therebetween that opens to a first end of the buckle commissure clamp,

the first end portion is connected to the first arm by the first bent portion,

the second end portion is connected to the second arm by the second bent portion,

the first end portion, the first arm, and the first bent portion define a first gap therebetween that opens to the second end of the buckle commissure clamp, and

the second end portion, the second arm, and the second bent portion define a second gap therebetween that opens to the second end of the buckle commissure clamp, and

wherein, for each buckle commissure clamp:

the first and second leaflet tabs extend through the central gap from a first side of said buckle commissure clamp to a second side of the buckle commissure clamp; and

free ends of the first and second leaflet tabs at said second side are coupled to each other.

15 . The prosthetic heart valve of claim 14 , wherein the free ends of the first and second leaflet tabs are coupled together using one or more sutures.

16 . A prosthetic heart valve comprising:

a frame that is radially collapsible and expandable between a radially-compressed configuration and a radially-expanded configuration, the frame having an inflow end and an outflow end separated from the inflow end along an axial direction of the frame;

a plurality of buckle commissure clamps coupled to the frame, each buckle commissure clamp having one or more gaps; and

a valvular structure formed by a leaflet assembly, the leaflet assembly comprising a plurality of leaflets, each leaflet having a pair of tabs, each leaflet tab being coupled to a respective one of the buckle commissure clamps by being wrapped around at least a portion of the buckle commissure clamp,

wherein each buckle commissure clamp comprises first and second arms, first and second end portions, and first, second, and third bent portions,

the first and second arms are connected together by the third bent portion at a second end of the buckle commissure clamp,

the first and second arms and the third bent portion define a central gap therebetween that opens to a first end of the buckle commissure clamp,

the first end portion is connected to the first arm by the first bent portion,

the second end portion is connected to the second arm by the second bent portion,

the first end portion, the first arm, and the first bent portion define a first gap therebetween that opens to the second end of the buckle commissure clamp, and

the second end portion, the second arm, and the second bent portion define a second gap therebetween that opens to the second end of the buckle commissure clamp, and

wherein, for each buckle commissure clamp:

the first and second leaflet tabs extend through the central gap from a first side of said buckle commissure clamp to a second side of the buckle commissure clamp; and

one or more coupling members extend between and are attached to respective ends of the first and second leaflet tabs at the second side of the buckle commissure clamp.

17 . The prosthetic heart valve of claim 16 , wherein the one or more coupling members are attached to the first and second leaflet tabs by one or more sutures.

18 . The prosthetic heart valve of claim 16 , for each buckle commissure clamp, a wedge is disposed adjacent to the central gap between the first and second leaflet tabs and the coupling member along a radial direction of the frame.

19 . The prosthetic heart valve of claim 18 , wherein the wedge is attached to the coupling member.