Method for making polymer heart valves with leaflets having uncut free edges

• US 6,475,239 B1
• Filed: 10/13/1998
• Issued: 11/05/2002
• Est. Priority Date: 10/13/1998
• Status: Expired due to Term

• Current Assignee: Corcym SRL (LivaNova Plc)
• Original Assignee: Sulzer Carbomedics Inc. (Zimmer Biomet Holdings, Inc.)
• Inventors: Sarnowski, Edward J., Campbell, Louis A., Moe, Riyad
• Primary Examiner(s): SNOW, BRUCE EDWARD
• Application Number:
  US09/170,925
• Time in Patent Office: 1,484 Days
• Field of Search: 623/2, 623/900, 623/901, 623/2.12, 623/2.15, 623/2.19, 264/299, 264/320, 264/328.8
• US Class Current: 623/2.12
• 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: Y10S 623/901 Method of manufacturing prosthetic device

Abstract

A method for manufacturing a prosthetic heart valve. An elastic valve body and at least one leaflet are formed on a mold. The leaflet has a free edge which is formed by the mold without cutting the leaflet at the free edge.

Claims

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

1) providing a mold comprising a heart valve body portion and at least one leaflet portion integral with said valve body portion, said leaflet portion comprising a free edge portion;

2) forming a valve body having at least one polymeric leaflet in said mold, said leaflet comprising a free edge;

3) removing said valve body from said mold to obtain a heart valve having at least one leaflet with an uncut free edge; and

4) implanting said heart valve in a patient without cutting said free edge.

2. The method of claim 1 wherein said providing step comprises:

providing an outflow mold having a recess in the shape of the free edge of said leaflet, said outflow mold defining a generally concave outflow side of said leaflet and at least a portion of a generally convex inflow side of said leaflet adjacent said free edge of said leaflet; and

providing an inflow mold defining another portion of said inflow side of said leaflet, said outflow mold and said inflow mold meeting at a separation line on said inflow side of said leaflet.

3. The method of claim 1 wherein said providing step comprises:

providing an inflow mold having a recess in the shape of the free edge of said leaflet, said inflow mold defining a generally convex inflow side of said leaflet and at least a portion of a generally concave outflow side of said leaflet adjacent said free edge of said leaflet; and

providing an outflow mold defining another portion of said outflow side of said leaflet, said inflow mold and said outflow mold meeting at a separation line on said outflow side of said leaflet.

4. The method of claim 1 wherein said providing step comprises:

providing an outflow mold defining a generally concave outflow side of said leaflet; and

providing an inflow mold defining a generally convex inflow side of said leaflet, said outflow mold and said inflow mold meeting at a separation line on said free edge of said leaflet.

5. The method of claim 1 wherein said providing step comprises:

providing an inflow mold having a recess in the shape of the free edge of said leaflet, said inflow mold defining a generally convex inflow side of said leaflet and at least a portion of an outflow side of said leaflet adjacent said free edge of said leaflet, and said inflow mold terminating at a point spaced away from said free edge, said point forming a line along said outflow side of said leaflet;

and wherein said method further comprises trimming said leaflet along said line.

6. The method of claim 1 wherein said forming step comprises dip casting.

7. The method of claim 1, wherein said forming step comprises compression molding.

8. The method of claim 1 wherein said forming step comprises injection molding.

9. The method of claim 1 wherein said removing step further comprises the step of cutting an opening in the valve, said cutting occurring away from said free edge.

10. The method of claim 1 wherein said forming step comprises molding the leaflet in a partially open position.

11. The method of claim 1 wherein said forming step comprises molding the leaflet in a fully open position.

12. A method of making and implanting a prosthetic heart valve comprising:

providing a mold for a heart valve having a valve body and a plurality of polymeric leaflets, each of said leaflets comprising a free edge, said mold comprising a free edge portion for forming each said free edge independently of the other free edges;

forming said valve body and said plurality of leaflets in said mold;

removing said valve body and said leaflets from said mold without cutting any of said free edges; and

implanting said heart valve in a patient.