# US 11,896,481 B2 · Truncated leaflet for prosthetic heart valves

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- Number: US 11,896,481 B2
- Document ID: US11896481B2
- Status: Granted
- Kind: B2
- Application number: 16/440,340
- Filed: 2019-06-13
- Published: 2020-01-02
- Granted: 2024-02-13
- Earliest claimed: 2012-12-19
- Assignees: Edwards Lifesciences Corporation
- Applicants: Edwards Lifesciences Corporation
- Inventors: William C. Bruchman; Cody L. Hartman
- Web page: https://patentgrep.com/patent/US11896481B2

## CPC

- A61F 2/2409: {Support rings therefor, e.g. for connecting valves to tissue (annuloplasty rings A61F2/2442)}
- A61F 2/24: Heart valves {; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body}
- A61F 2/2412: {with soft flexible valve members, e.g. tissue valves shaped like natural valves}
- A61F 2/2415: {Manufacturing methods}
- A61F 2/2418: {Scaffolds therefor, e.g. support stents}
- A61F 2230/00: Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F 2230/0023: triangular
- A61F 2230/0026: trapezoidal
- A61F 2240/001: Designing or manufacturing processes
- A61F: FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS (dental prosthetics A61C)

## Abstract

Described embodiments are directed toward prosthetic valves having leaflets of a particular shape that improves bending character without requiring a long length valve. In accordance with an embodiment, a prosthetic valve comprises a leaflet frame, a plurality of leaflets that are coupled to the leaflet frame, where each leaflet has a free edge and a base. The base of each leaflet is truncated in which the leaflet in cross section shows a line in an alpha plane onto the leaflet frame.

## Claims

### Claim 1

A prosthetic valve with three or more leaflets having an inflow end and an outflow end, the prosthetic valve comprising:
a frame assembly having a central longitudinal axis and including a leaflet frame and a cover having a generally tubular shape, the cover being coupled to the leaflet frame such that the cover at least partially covers the leaflet frame, the leaflet frame defining a plurality of leaflet windows, the plurality of leaflet windows each defining an isosceles trapezoid and including a leaflet window side and a leaflet window base, the leaflet frame having a cylindrical shape; and
a plurality of leaflets coupled to the frame assembly, each leaflet including a leaflet free edge configured to abut an adjacent leaflet free edge when the plurality of leaflets transition from an open position to a closed position to stop fluid flow through the prosthetic valve, a first leaflet side coupled to the frame assembly, a second leaflet side coupled to the frame assembly, and a leaflet base coupled to the frame assembly along the leaflet base, the leaflet base forming a line of attachment along the frame assembly, the leaflet base being positioned opposite the leaflet free edge and being flat in a plane transverse to the central longitudinal axis of the frame assembly, the leaflet frame including a flat portion with which the leaflet base forms the line of attachment.

### Claim 2 (depends on 1)

The prosthetic valve of claim 1, wherein the leaflet frame includes a plurality of commissure posts and each leaflet base of the plurality of leaflets is located inferior and exterior to a line joining apices of two adjacent commissure posts of the leaflet frame.

### Claim 3 (depends on 1)

The prosthetic valve of claim 1, wherein the leaflet frame has a tubular shape.

### Claim 4 (depends on 1)

The prosthetic valve of claim 1, wherein the prosthetic valve comprises a film that is coupled to the leaflet frame and which defines at least one of the plurality of leaflets.

### Claim 5 (depends on 4)

The prosthetic valve of claim 4, wherein the film is coupled to an outer surface of the leaflet frame.

### Claim 6 (depends on 4)

The prosthetic valve of claim 4, wherein the film is coupled to an inner surface of the leaflet frame.

### Claim 7 (depends on 4)

The prosthetic valve of claim 4, wherein the film is coupled to an inner surface and an outer surface of the leaflet frame.

### Claim 8 (depends on 1)

The prosthetic valve of claim 1, wherein each leaflet of the plurality of leaflets includes a central region that is planar when the plurality of leaflets are each in a closed position under unpressurized conditions.

### Claim 9 (depends on 8)

The prosthetic valve of claim 8, wherein each central region of each of the leaflets includes two sides that converge.

### Claim 10 (depends on 1)

The prosthetic valve of claim 1, wherein the leaflet frame comprises a leaflet frame outflow end and a leaflet frame inflow end opposite the leaflet frame outflow end, and further wherein the leaflet frame defines a plurality of leaflet windows from which the plurality of leaflets extend, each of the plurality of leaflet windows having two sides that diverge in a direction toward the leaflet frame outflow end.

### Claim 11 (depends on 10)

The prosthetic valve of claim 10, wherein the leaflet frame further comprises a plurality of commissure posts extending axially from adjacent windows of the plurality of leaflet windows, each commissure post having a length extending toward the leaflet frame outflow end.

### Claim 12 (depends on 10)

The prosthetic valve of claim 10, wherein a leaflet window side of one leaflet window is interconnected with a leaflet window side of an adjacent leaflet window of the plurality of leaflet windows.

### Claim 13 (depends on 1)

The prosthetic valve of claim 1, wherein the plurality of leaflet windows includes leaflet frame defines three interconnected leaflet windows, the three interconnected leaflet windows being interconnected by a base element, the three interconnected leaflet windows each defining an isosceles trapezoid.

### Claim 14 (depends on 1)

The prosthetic valve of claim 1, wherein the prosthetic valve comprises a collapsed configuration and an expanded configuration for transcatheter delivery.

### Claim 15 (depends on 1)

The prosthetic valve of claim 1, wherein each of the plurality of leaflets includes a synthetic material.

### Claim 16 (depends on 1)

The prosthetic valve of claim 1, wherein each of the plurality of leaflets comprises a laminate material.

### Claim 17 (depends on 16)

The prosthetic valve of claim 16, wherein each of the plurality of leaflets is a single layer of the laminate material.

### Claim 18 (depends on 1)

The prosthetic valve of claim 1, wherein each of the plurality of leaflets comprises a fluoropolymer membrane.

### Claim 19 (depends on 1)

The prosthetic valve of claim 1, wherein each of the plurality of leaflets comprises a biological tissue material.

### Claim 20 (depends on 1)

The prosthetic valve of claim 1, wherein the plurality of leaflets are cut leaflets, the leaflet base including a cut edge, the cut edge of the leaflet base being coupled to the frame assembly.

### Claim 21 (depends on 1)

The prosthetic valve of claim 1, wherein the plurality of leaflets are molded leaflets.

### Claim 22 (depends on 1)

The prosthetic valve of claim 1, wherein the leaflet base is bonded to the leaflet frame along the line of attachment.

### Claim 23 (depends on 1)

The prosthetic valve of claim 1, wherein the leaflet base is coupled to the leaflet frame at a center of the leaflet base.

### Claim 24 (depends on 1)

The prosthetic valve of claim 1, wherein the leaflet window side diverges outwardly at an obtuse angle from the leaflet window base.

### Claim 25

A prosthetic valve with three or more leaflets having an inflow end, an outflow end, and a valve axis extending between the inflow end and the outflow end of the prosthetic valve and comprising:
a leaflet frame assembly including a leaflet frame and a tubular cover, the leaflet frame assembly defining a plurality of leaflet attachment lines extending in a plane that is transverse to the valve axis, the leaflet attachment lines being defined on flat portions of the leaflet frame assembly, the leaflet frame including a flat portion with which the leaflet base forms the line of attachment, the leaflet frame defining a plurality of leaflet windows, the plurality of leaflet windows each defining an isosceles trapezoid and including a leaflet window side and a leaflet window base, the leaflet frame having a cylindrical shape; and
a plurality of leaflets each having a first side, a second side opposite the first side, a leaflet free edge and a leaflet base opposite to the leaflet free edge that is flat and which is coupled to one of the plurality of leaflet attachment lines defined by the leaflet frame assembly along the leaflet base forming a line of attachment along the leaflet frame assembly at the flat portions of the leaflet frame assembly.
