Prosthetic valves, frames and leaflets and methods thereof

• US 9,737,398 B2
• Filed: 12/18/2013
• Issued: 08/22/2017
• Est. Priority Date: 12/19/2012
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: W. L. Gore & Associates (W.L. Gore & Associates)
• Inventors: Bruchman, William C., Crawford, Daniel A., Hagaman, Logan R., Hartman, Cody L.
• Primary Examiner(s): Sweet, Thomas J
• Assistant Examiner(s): Schutte, Wade P
• Application Number:
  US14/133,563
• Publication Number:
  US 20140180400A1
• Time in Patent Office: 1,343 Days
• Field of Search: None
• CPC Class Codes: A61F 2/2412 with soft flexible valve members, e.g. tissue valves shaped like natural valves check valves with flexible valve members in general F16K15/14
• CPC Class Codes: A61F 2/2415 Manufacturing methods
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2230/0023 triangular
• CPC Class Codes: A61F 2230/0026 trapezoidal

Abstract

Described embodiments are directed toward prosthetic heart valve leaflets of particular shapes that control bending character. In accordance with an embodiment, a prosthetic heart valve comprises a leaflet frame having a generally tubular shape with attached film. The leaflet frame defines a plurality of leaflet windows. The film defines at least one leaflet extending from each of the leaflet windows. Each leaflet attachment zone on the leaflet frame has substantially the shape of an isosceles trapezoid having two leaflet sides, a leaflet base and a leaflet free edge opposite the leaflet base. The two leaflet sides diverge from the leaflet base, wherein the leaflet base is substantially flat.

Claims

1. A prosthetic valve, comprising:

a leaflet frame having a tubular shape, the leaflet frame defining a plurality of leaflet windows wherein each of the leaflet windows includes two leaflet window sides, a leaflet window base, and a leaflet window top; and

a film coupled to the leaflet frame and defining a plurality of leaflets, one of the plurality of leaflets being coupled to and extending from each of the leaflet windows, wherein each leaflet has the shape of an isosceles trapezoid having two leaflet sides, a leaflet base and a leaflet free edge opposite the leaflet base, wherein the two leaflet sides diverge from the leaflet base, wherein the leaflet base is substantially flat, wherein the leaflet base of each leaflet is truncated in which the leaflet in cross section shows a line in an alpha plane onto the leaflet frame, in which the truncation is a straight line across the leaflet base of the leaflet and perpendicular to a valve axis, wherein the leaflet base is coupled to the leaflet window base and wherein each of the two leaflet sides are coupled to one of the two leaflet window sides.

2. The prosthetic valve of claim 1, wherein each leaflet includes a central region and two side regions on opposite sides of the central region, wherein the central region is defined by a shape of an isosceles triangle defined by two central region sides, the leaflet base and the leaflet free edge, wherein the two central region sides converge from the leaflet base, and wherein each of the side regions have a shape of a triangle and each are defined by one of the central region sides, one of the leaflet sides, and the leaflet free edge.

3. A prosthetic valve, comprising:

a leaflet frame; and

a plurality of leaflets coupled to the leaflet frame, each leaflet including a free edge and a base, wherein the base of each leaflet is truncated in which a cross section of the leaflet that is parallel with a valve axis at the base defines a straight line in an alpha plane, in which the truncation defines a straight line across the base of the leaflet that is perpendicular to the valve axis, wherein the alpha plane is perpendicular to the valve axis and passes through the base.

4. The prosthetic valve of claim 3, further comprising:

an outer frame having a tubular shape, the leaflet frame having a tubular shape and defining a plurality of leaflet windows, the leaflet frame and outer frame coupled at least in part by a contiguous portion of a film, at least a first portion of the contiguous portion of the film being contained between and coupling the leaflet frame and outer frame that minimizes relative movement and prevents contact between the leaflet frame and outer frame, wherein a second portion of the contiguous portion of the film defines each leaflet that extends from each of the leaflet windows.

5. The prosthetic valve of claim 3, in which truncation of each leaflet is located inferior and exterior to a line joining apices of two adjacent commissural posts.

6. The prosthetic valve of claim 3, the leaflet frame having a tubular shape, the leaflet frame defining a plurality of leaflet windows wherein each of the leaflet windows includes two leaflet window sides, a leaflet window base, and a leaflet window top;

and

a film coupled to the leaflet frame and defining at least one leaflet extending from each of the leaflet windows, wherein each leaflet has the shape of an isosceles trapezoid having two leaflet window sides, a leaflet base and a free edge opposite the leaflet base, wherein the two leaflet sides diverge from the leaflet base, wherein the leaflet base is substantially flat, wherein the leaflet base is coupled to the window base and wherein each of the two leaflet sides are coupled to one of the two window sides.

7. The prosthetic valve of claim 6, wherein each leaflet includes a central region and two side regions on opposite sides of the central region, wherein the central region is defined by a shape of an isosceles triangle defined by two central region sides, the leaflet base and the leaflet free edge, wherein the two central region sides converge from the leaflet base, and wherein each of the side regions have a shape of a triangle and each are defined by one of the central region sides, one of the leaflet sides, and the leaflet free edge.