Method for producing heart valves

• US 6,165,215 A
• Filed: 10/29/1998
• Issued: 12/26/2000
• Est. Priority Date: 05/05/1996
• Status: Expired due to Fees

• Current Assignee: H.D.S. Systems, Ltd.
• Original Assignee: H.D.S. Systems, Ltd.
• Inventors: Haimovich, Dudu, Sondak, Ehad, Rottenberg, Dan
• Primary Examiner(s): Milano, Michael J.
• Application Number:
  US09/180,072
• Time in Patent Office: 789 Days
• Field of Search: 623/2.12, 623/922, 623/918, 623/909, 623/913, 623/916, 623/2.17
• 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: A61M 60/113 in other functional devices, e.g. dialysers or heart-lung machines
• CPC Class Codes: A61M 60/851 Valves
• CPC Class Codes: A61M 60/896 having flexible or resilient parts, e.g. flap valves
• CPC Class Codes: Y10S 623/91 Heart

Abstract

A method for producing valves for blood flow control having an outer sleeve and a plurality of flexible leaflets fixed to an inner surface of the sleeve, including: molding the valve to a first shape, in which the valve leaflets are in a closed position; holding the valve in a second desired shape, in which the valves are in an open position; and immersing the valve in a hot liquid while holding it in the second shape.

Claims

1. A method for producing valves for blood flow control having an outer sleeve and a plurality of flexible leaflets fixed to an inner surface of the sleeve, compnrsing:

molding the valve to a first shape in which the valve leaflets are in a closed position;

holding the valve in a second desired shape, in which the valves are in an open position; and

immersing the valve in a hot liquid while holding it in the second shape.

2. A method according to claim 1 wherein holding the leaflets in an open position comprises inserting a mandrill into the valve.

3. A method according to claim 1 wherein immersing the valve in a bath of hot liquid increases the flexibility of the leaflets.

4. A method according to claim 1 wherein immersing the valve in the bath of hot liquid sets the valve in the second, desired shape.

5. A method according to claim 1 wherein molding the valve comprises integrally molding the sleeve and the leaflets.

6. A method according to claim 5 wherein integrally molding the sleeve and the leaflets comprises injecting a polymer material into a mold at high pressure.

7. A method according to claim 6 wherein injecting the molding under high pressure comprises injecting the polymer at a pressure greater than 2800 atm.

8. A method according to claim 6 wherein injecting the molding under high pressure comprises injecting the polymer at a pressure greater than 3500 atm.

9. A method according to claim 1 wherein immersing the valve in a hot liquid comprises immersing the valve in hot water.

10. A method according to claim 1 wherein immersing the valve in a hot liquid comprises immersing the valve in liquid at a temperature greater than 60°

C.

11. A method according to claim 1 wherein immersing the valve in a hot liquid comprises immersing the valve in liquid at a temperature greater than 80°

C.

12. A method according to claim 1 wherein immersing the valve in a hot liquid comprises immersing the valve in liquid at a temperature substantially in the range of 82-84°

C.

13. A method in accordance with claim 1 wherein immersing the valve comprises immersing the valve in a liquid for approximately two minutes.

14. A method according to claim 1 and comprising immersing the valve in cold liquid after said immersion in hot liquid.

15. A method according to claim 14 wherein the cold liquid is cold water.

16. A method according to claim 14 wherein the cold liquid has a temperature substantially in the range of 68-77°

C.

17. A method according to claim 14 wherein said leaflet valves are held in said second. desired shape during said immersion in cold liquid.

18. A method according to claim 14 and comprising immersing the valve a second time in hot liquid followed by immersing the valve a second time in cold liquid.

19. A method according to claim 1 wherein immersing the valve in a liquid comprises immersing the valve in a bath of liquid.

20. A method for producing valves for blood flow control having an outer sleeve and a plurality of flexible leaflets fixed to an inner surface of the sleeve, comprising:

molding the valve to a first shape, by injecting a polymer material into a mold at high pressure;

holding the valve in a second desired shape; and

immersing the valve in a hot liquid while holding it in the second shape,

wherein molding the valve comprises integrally molding the sleeve and the leaflets.

21. A method for producing valves for blood flow control having an outer sleeve and a plurality of flexible leaflets fixed to an inner surface of the sleeve, comprising:

molding the valve to a first shape;

holding the valve in a second desired shape; and

immersing the valve in hot liquid at a temperature of greater than 60°

C., while holding it in the second shape.

22. A method according to claim 21 wherein the temperature is greater than 80°

C.

23. A method according to claim 21 wherein the temperature is substantially in the range of 82-84°

C.

24. A method for producing valves for blood flow control having an outer sleeve and a plurality of flexible leaflets fixed to an inner surface of the sleeve, comprising:

(a) molding the valve to a first shape;

(b) holding the valve in a second desired shape;

(c) immersing the valve in a hot liquid while holding it in the second shape

(d) immersing the valve in a cold liquid after immersion of the valve in a hot liquid; and

(e) repeating (c) and (d).