Methods for improved prosthetic heart valve with leaflet shelving

• US 10,660,745 B2
• Filed: 09/29/2017
• Issued: 05/26/2020
• 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.
• Primary Examiner(s): Lopez, Leslie
• Application Number:
  US15/720,441
• Publication Number:
  US 20180021128A1
• Time in Patent Office: 970 Days
• Field of Search: None
• 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, valve leaflets are operable to bend along a base of the valve leaflets.

Claims

1. A prosthetic valve comprising:

a support structure having a longitudinal axis and defining a leaflet attachment zone between a pair of adjacent commissure posts;

a leaflet coupled to and extending from the leaflet attachment zone, the leaflet having a free edge at one end of the leaflet and a base at another end of the leaflet opposite the free edge, the base of the leaflet being coupled to the support structure to define a linear base segment such that the leaflet is configured to bend from the base toward the free edge about the linear base segment during opening-closing cycles associated with blood pressure differentials across the prosthetic valve, the linear base segment of the leaflet having a first side, a second side opposite the first side, and a center between the first side and the second side of the linear base segment, each of the first side and the second side of the linear base segment defining a first radial distance from the longitudinal axis of the support structure and the center of the linear base segment defining a second radial distance from the longitudinal axis of the support structure that is less than the first radial distance.

2. The prosthetic valve of claim 1, wherein the leaflet has a planar zone in a central region, wherein the planar zone is substantially planar, wherein the planar zone defines a planar zone base, the planar zone defining a shape having an area.

3. The prosthetic valve of claim 2, wherein the leaflet frame has a generally tubular shape and a majority of the planar zone of the leaflet is located inferior and exterior to a line joining apices of the pair of adjacent commissure posts.

4. The prosthetic valve of claim 2, wherein the planar zone has a generally triangular shape.

5. The prosthetic valve of claim 2, wherein the planar zone has a generally trapezoidal shape.

6. The prosthetic valve of claim 2, wherein the planar zone extends to the free edge of the leaflet.

7. The prosthetic valve of claim 2, wherein the planar zone extends to the base of the leaflet.

8. The prosthetic valve of claim 1, wherein the leaflet has a generally trapezoid shape.

9. The prosthetic valve of claim 1, wherein the leaflet is defined by a material coupled to an outer surface of the support structure.

10. The prosthetic valve of claim 1, wherein the leaflet is defined by a material coupled to an inner surface of the support structure.

11. The prosthetic valve of claim 1, wherein the leaflet is defined by a material coupled to an inner surface and an outer surface of the support structure.

12. The prosthetic valve of claim 1, wherein the prosthetic valve is configured for transcatheter delivery and to transition from a collapsed configuration to an expanded configuration.

13. The prosthetic valve of claim 1, wherein the leaflet includes a first film positioned inside the support structure and a second film positioned outside the support structure, the first film bonded to the second film.

14. The prosthetic valve of claim 1, wherein the leaflet is provided with a planar zone that is bounded at a planar zone base defining a straight line corresponding to the linear base segment.

15. The prosthetic valve of claim 1, wherein the leaflet is characterized by an absence of intersecting creases.

16. The prosthetic valve of claim 1, wherein the support structure comprises a plurality of frame elements spanning the leaflet attachment zone.

17. The prosthetic valve of claim 16, wherein the plurality of frame elements are associated with an outer frame positioned coaxially with the support structure.

18. A prosthetic valve comprising:

a support structure including a plurality of commissure posts, defining a plurality of leaflet attachment zones between the commissure posts, and having a longitudinal axis and a plurality of chords defined between adjacent ones of the commissure posts; and

a plurality of leaflets, each of the plurality of leaflets extending from one of the leaflet attachment zones and having a free edge at one end and a base at an opposite end from the free edge that is coupled to the support structure along a linear base segment about which a corresponding one of the plurality of leaflets is configured to bend from the linear base segment toward the free edge during opening and closing associated with blood pressure differentials across the prosthetic valve, each of the leaflets further having a planar zone including a planar zone base that is coincident with one of the linear base segments, each of the linear base segments having a length that is less than a length of the plurality of chords.

19. A prosthetic valve comprising:

a leaflet frame having a first end and a second end opposite the first end, the leaflet frame including a plurality of commissure posts and a plurality of leaflet windows each having a top, a bottom opposite the top, a first side, and a second side;

a plurality of leaflets coupled to two of the commissure posts of the leaflet frame, each leaflet extending from one of the plurality of leaflet windows and having a base at one end that is truncated and substantially flat in a plane that is transverse to a longitudinal axis of the prosthetic valve, each of the plurality of leaflets having a free end at an opposite end to a respective one of the bases, each of the bases being formed by a fold region defining a line segment that is axially offset from the second end of the leaflet frame and the base being spaced apart from the bottom of one of the leaflet windows in an axial direction such that each of the plurality of leaflet is configured to bend from a corresponding one of the line segments toward a corresponding one of the free edges during opening and closing associated with blood pressure differentials across the prosthetic valve.