Replacement heart valves and their methods of use and manufacture

• US 9,539,089 B2
• Filed: 01/30/2015
• Issued: 01/10/2017
• Est. Priority Date: 05/09/2014
• Status: Active Grant

• Current Assignee: Foldax, Inc.
• Original Assignee: Foldax, Inc.
• Inventors: Beith, Jason G.
• Primary Examiner(s): STEWART, ALVIN J
• Application Number:
  US14/611,071
• Publication Number:
  US 20150320554A1
• Time in Patent Office: 711 Days
• Field of Search: 623/1.24, 623/1.26, 623/2.14, 623/2.15, 623/2.16, 623/18, 623/2.19
• 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 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2220/0075 sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61F 2230/0069 cylindrical

Abstract

A prosthetic valve has a support structure that meets with a plurality of leaflets capable of transitioning between open and closed states. The support structure can include a base frame with a polymer coating and the leaflets can be artificial. The interface between the support structure and each leaflet can be at least partially convex when viewed from an exterior of the support structure along a normal to a plane formed by a central axis of the support structure and a central axis of the leaflet.

Claims

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

molding or casting only three artificial leaflets onto a support structure having a central axis oriented in a blood flow direction through an interior of the support structure,

wherein each leaflet has a movable part with a base along the support structure and a free edge allowed to move independent of the support structure, the movable part of each leaflet also having a central axis extending between the base and the free edge,

wherein the movable part of each leaflet is movable between a first position, for preventing the flow of blood through an interior of the support structure, and a second position, for allowing the flow of blood through the interior of the support structure,

wherein the base of the movable part of each leaflet is the boundary where the movable part of the leaflet contacts the support structure,

wherein the support structure is substantially cylindrical where the base of the movable part of each leaflet meets the support structure, and

wherein, for each leaflet, a profile of the base of the movable part of the leaflet is at least partially convex when viewed from an exterior side view of the support structure normal to a plane formed by the central axis of the support structure and the central axis of the movable part of the leaflet when in the first position.

2. The method of claim 1, wherein molding or casting the three artificial leaflets onto the support structure comprises:

placing the support structure over a mandrel;

dipping the support structure and mandrel into a polymer; and

removing the support structure and mandrel such that the three artificial leaflets are formed on a downstream edge of the support structure.

3. The method of claim 2, wherein the support structure and mandrel are dipped into the polymer a plurality of times.

4. The method of claim 2, further comprising coating the support structure with the polymer prior to dipping the support structure and mandrel into the polymer.

5. The method of claim 2, wherein the support structure is fabricated from a first material and wherein the polymer into which the support structure and mandrel are dipped is a material that is different from the first material.

6. The method of claim 5, further comprising pre-coating the support structure with the polymer prior to dipping the support structure and the mandrel into the polymer.

7. The method of claim 6, wherein the polymer into which the support structure and mandrel are dipped has the same or a relatively higher viscosity than the polymer used to pre-coat the support structure.

8. The method of claim 1, wherein, for each leaflet, the profile of the base of the movable part of the leaflet is at least partially convex and at least partially concave when viewed from the exterior side view of the support structure normal to the plane formed by the central axis of the support structure and the central axis of the movable part of the leaflet when in the first position.

9. The method of claim 1, wherein, for each leaflet, the entire profile of the base of the movable part of the leaflet is at least partially convex when viewed from the exterior side view of the support structure normal to the plane formed by the central axis of the support structure and the central axis of the movable part of the leaflet when in the first position.

10. The method of claim 1, further comprising coupling a sewing cuff to an annular base portion at an upstream end of the prosthetic heart valve.

11. The method of claim 1, wherein the manufactured prosthetic heart valve is not radially collapsible for placement into an intravascular delivery device or a trans-apical delivery device.

12. The method of claim 1, wherein the three artificial leaflets and the support structure are fabricated from the same material.

13. The method of claim 1, wherein the support structure is cylindrical where the base of each leaflet transitions to the support structure.

14. The method of claim 1, wherein the entirety of an inner lumen surface of the support structure is substantially cylindrical.

15. The method of claim 1, further comprising trimming the three artificial leaflets to the desired shape.