METHODS FOR IMPROVED PROSTHETIC HEART VALVE WITH LEAFLET SHELVING

• US 20150305862A1
• Filed: 07/06/2015
• Published: 10/29/2015
• 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., Hartman, Cody L.
• Granted Patent: US 9,827,089 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: A61F 2/2409 Support rings therefor, e.g. for connecting valves to tissue annuloplasty rings A61F2/2442
• 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
• CPC Class Codes: A61F 2240/001 Designing or manufacturing processes

Abstract

Described embodiments are directed toward prosthetic valve leaflets of particular configurations that control bending character. In embodiments provided herein, a valve leaflet is provided with a planar zone that is bounded at a planar zone base by a straight line, wherein the leaflet is operable to bend along a base of the planar zone.

Claims

1. A method of forming a prosthetic heart valve, comprising:

providing a leaflet frame having a tubular shape that defines a longitudinal axis, the leaflet frame defining a plurality of commissure posts and 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;

providing a film;

wrapping the film about the leaflet frame bringing more than one layer of the film into contact with additional layers of the film defining at least one leaflet extending from each of the leaflet windows; and

bonding the layers of the film to itself and to the leaflet frame such that each leaflet has substantially a shape of an isosceles trapezoid having two leaflet 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 leaflet window base and wherein each of the two leaflet sides are coupled to one of the two leaflet window sides between two of the commissure posts that provides a generally annular support structure, each leaflet having a planar zone in a central region, wherein the planar zone is substantially planar, wherein the planar zone defines a shape having an area, wherein the area is larger nearer the leaflet base than the free edge, wherein the leaflet is operable to bend about a straight base segment of the leaflet base in which a planer zone base of the planar zone of the leaflet is a substantially straight line that has a length that is less than a length of a chord defined as a straight line that extends from two of the commissure posts.

2. The method of forming a prosthetic heart valve of claim 1, wherein providing a leaflet frame comprises providing a leaflet frame having a plurality of spaced apart leaflet windows each defining substantially an isosceles triangle interconnected by a base element therebetween, wherein each leaflet window side is defined by a side of one triangle and a side of an adjacent triangle, and wherein each leaflet window base is defined by the base element.

3. The method of forming a prosthetic heart valve of claim 1, wherein providing a leaflet frame comprises providing a leaflet frame having a plurality of spaced apart interconnected leaflet windows each defining substantially isosceles trapezoids, wherein each leaflet window side is defined by sides of the isosceles trapezoid, and wherein each leaflet window base is defined by a base element.

4. The method of forming a prosthetic heart valve of claim 1, wherein wrapping the film about the leaflet frame comprises wrapping a first film about an inner surface of the leaflet frame and a second film about an outer surface of the leaflet frame, wherein the leaflets are defined by the first film and the second film bonded together in the leaflet windows.

5. The method of forming a prosthetic heart valve of claim 1, wherein bonding the layers of the film to itself and to the leaflet frame comprises bonding the layers of the film to itself and to the leaflet frame such that each straight base segment has a length of less than a length of a chord defined as a straight line that extends from two of the commissure posts and lies on a plane that is perpendicular to the longitudinal axis of the leaflet frame,

wherein each straight base segment is parallel to a respective chord,

wherein each leaflet base has a flat portion and defines a shelf structure and each leaflet base is coupled to the leaflet frame at its shelf structure.

6. A method of forming a prosthetic heart valve, comprising:

providing a leaflet frame having a tubular shape that defines a longitudinal axis, the leaflet frame defining a plurality of commissure posts and 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;

providing a film;

wrapping the film about the leaflet frame bringing more than one layer of the film into contact with additional layers of the film defining at least one leaflet extending from each of the leaflet windows; and

bonding the layers of the film to itself and to the leaflet frame, wherein each leaflet is thereby coupled to two of the commissure posts and includes a free edge and a leaflet base, where each leaflet is operable to bend about a straight base segment of its leaflet base,

wherein each straight base segment has a length of less than a length of a chord defined as a straight line that extends from two of the commissure posts and lies on a plane that is perpendicular to the longitudinal axis of the leaflet frame,

wherein each straight base segment is parallel to a respective chord,

wherein each leaflet base has a flat portion and defines a shelf structure and each leaflet base is coupled to the leaflet frame at its shelf structure.

7. The method of forming a prosthetic heart valve of claim 6, wherein bonding the layers of the film to itself and to the leaflet frame comprises bonding the layers of the film to itself and to the leaflet frame such that each leaflet has substantially a shape of an isosceles trapezoid having two leaflet 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 leaflet window base and wherein each of the two leaflet sides are coupled to one of the two leaflet window sides between two of the commissure posts that provides a generally annular support structure, each leaflet having a planar zone in a central region, wherein the planar zone is substantially planar, wherein the planar zone defines a shape having an area, wherein the area is larger nearer the leaflet base than the free edge, wherein the leaflet is operable to bend about a straight base segment of the leaflet base in which a planer zone base of the planar zone of the leaflet is a substantially straight line that has a length that is less than a length of a chord defined as a straight line that extends from two of the commissure posts.

8. The method of forming a prosthetic heart valve of claim 6, wherein providing a leaflet frame comprises providing a leaflet frame having a plurality of spaced apart leaflet windows each defining substantially an isosceles triangle interconnected by a base element therebetween, wherein each leaflet window side is defined by a side of one triangle and a side of an adjacent triangle, and wherein each leaflet window base is defined by the base element.

9. The method of forming a prosthetic heart valve of claim 6, wherein providing a leaflet frame comprises providing a leaflet frame having a plurality of spaced apart interconnected leaflet windows each defining substantially isosceles trapezoids, wherein each leaflet window side is defined by sides of the substantially isosceles trapezoid, and wherein each leaflet window base is defined by a base element.

10. The method of forming a prosthetic heart valve of claim 6, wherein wrapping the film about the leaflet frame comprises wrapping a first film about an inner surface of the leaflet frame and a second film about an outer surface of the leaflet frame, wherein the leaflets are defined by the first film and the second film bonded together in the leaflet windows.