Heart valve leaflet with reinforced free margin

• US 6,174,331 B1
• Filed: 07/19/1999
• Issued: 01/16/2001
• Est. Priority Date: 07/19/1999
• Status: Expired due to Term

• Current Assignee: Corcym SRL (LivaNova Plc)
• Original Assignee: Sulzer Carbomedics Inc. (Zimmer Biomet Holdings, Inc.)
• Inventors: Sarnowski, Edward, Gong, Xiao Yan, Moe, Riyad E.
• Primary Examiner(s): Willse, David H.
• Assistant Examiner(s): GHERBI, SUZETTE JAIME J
• Application Number:
  US09/356,936
• Time in Patent Office: 547 Days
• Field of Search: 623/2-2-, 623/901
• 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: A61F 2250/0036 differing in thickness
• CPC Class Codes: Y10S 623/901 Method of manufacturing prosthetic device

Abstract

A flexible leaflet heart valve includes a base, a peripheral portion and a plurality of leaflets. Each leaflet includes a scalloped free margin having opposite ends and a mid-portion between the opposite ends. The opposite ends are attached to the peripheral portion of the valve at a first height above the base. The mid-portion of each free margin is positioned at a second height above the base, less than the first height. Each free margin is adjacent each other free margin to form a gap therebetween. Each leaflet is of a first thickness and at least a portion of each free margin is of a second thickness, greater than the first thickness. This may include extending the second thickness along the entire free margin between the opposite ends or extending the second thickness only along the mid-portion of the free margin.

Claims

1. A heart valve comprising:

a molded body including a plurality of leaflets, each leaflet including a scalloped free margin having opposite ends, the opposite ends being attached to

a peripheral portion of the valve;

each free margin being adjacent each other free margin to form a gap therebetween; and

each leaflet being a first thickness, and at least a portion of each free margin being of a second thickness, greater than the first thickness.

2. The heart valve as defined in claim 1 wherein the second thickness extends along the entire free margin between the opposite ends.

3. The heart valve as defined in claim 1 wherein each free margin includes a mid-portion between the opposite ends and the second thickness extends only along the mid-portion of the free margin.

4. The heart valve as defined in claim 1 wherein the peripheral portion of the valve is an annular surface including a plurality of commissures formed therewith.

5. The heart valve as defined in claim 4 wherein the opposite ends terminate adjacent a respective one of the commissures.

6. The heart valve as defined in claim 1 wherein the free margin is of the first thickness adjacent the opposite ends.

7. The heart valve as defined in claim 1 wherein each free margin includes a mid-portion between the opposite ends, the free margin being of the first thickness adjacent the opposite ends and being of the second thickness along the mid-portion of the free margin.

8. A flexible leaflet heart valve comprising:

a molded body including a base, a peripheral portion and a plurality of leaflets, each leaflet including a free margin having opposite ends and a mid-portion therebetween, the opposite ends being attached to the peripheral portion of the valve at a first height above the base, the mid-portion of each free margin being at a second height above the base, less than the first height;

each free margin being adjacent each other free margin to form a gap therebetween; and

each leaflet being of a first thickness, and at least a portion of each free margin being of a second thickness, greater than the first thickness.

9. The heart valve as defined in claim 8 wherein the peripheral portion of the valve is an annular surface including a plurality of commissures formed therewith.

10. The heart valve as defined in claim 9 wherein the opposite ends terminate adjacent a respective one of the commissures.

11. The heart valve as defined in claim 8 wherein the free margin is scalloped and is of the first thickness adjacent the opposite ends.

12. The heart valve as defined in claim 8 wherein each free margin is scalloped, the free margin being of the first thickness adjacent the opposite ends and being of the second thickness along the mid-portion of the free margin.

13. The heart valve as defined in claim 8 wherein each free margin is scalloped and the second thickness extends along the entire free margin between the opposite ends.

14. The heart valve as defined in claim 8 wherein the second thickness extends only along the mid-portion of the free margin.

15. A method of forming a flexible heart valve comprising the steps of:

molding a one-piece body including a base and a plurality of flexible relatively movable leaflets having a first thickness;

forming each leaflet to include a scalloped free margin having opposite ends and a mid-portion between the opposite ends;

shaping at least part of each free margin to include a second thickness greater than the first thickness;

extending the opposite ends to integrally connect to a peripheral portion of the valve; and

shaping each free margin to terminate adjacent each other free margin to define a continuous natural-state non-uniform gap therebetween which is maximized adjacent the mid-portion of each leaflet.

16. The method as defined in claim 15 wherein the step of extending the opposite ends includes the step of connecting the opposite ends to the valve at a first height above the base, and further comprises the step of shaping each free margin to position the mid-portion at a second height above the base, less than the first height.

17. The method as defined in claim 15 wherein the step of shaping at least a part of each free margin further comprises the step of extending the second thickness along the entire free margin between the opposite ends.

18. The method as defined in claim 16 wherein the step of shaping at least a part of each free margin further comprises the step of extending the second thickness along the entire free margin between the opposite ends.

19. The method as defined in claim 15 wherein the step of shaping at least a part of each free margin further comprises the step of extending the second thickness only along, the mid-portion of the free margin.

20. The method as defined in claim 16 wherein the step of shaping at least a part of each free margin further comprises the step of extending the second thickness only along the mid-portion of the free margin.

21. A heart valve comprising:

a molded body including a plurality of leaflets, each leaflet having a scalloped free margin; and

each leaflet being a first thickness, and only a portion of each free margin being of a second thickness greater than the first thickness.

22. The heart valve as defined in claim 21 further comprising a base and a peripheral portion including a plurality of commissures formed therewith, each free margin having opposite ends terminating at a respective one of the commissures, and a mid-portion therebetween, the opposite ends being attached to the commissures at a first height above the base, the mid-portion of each free margin being at a second height above the base, less than the first height.

23. A heart valve comprising:

a molded body including a plurality of leaflets, each leaflet including, a free margin having opposite ends, the opposite ends being attached to a peripheral portion of the valve;

each leaflet being of a first thickness;

each free margin including a second thickness greater than the first thickness; and

only a portion of each free margin being of a third thickness, greater than the second thickness.