Process and apparatus for the production of a heart valve prosthesis

• US 5,488,789 A
• Filed: 01/14/1994
• Issued: 02/06/1996
• Est. Priority Date: 05/08/1991
• Status: Expired due to Fees

• Current Assignee: Nika Health Products Ltd.
• Original Assignee: Nika Health Products Ltd.
• Inventors: Religa, Zbigniew, Kryzskow, Marek, Stolarzewicz, Bogdan, Cichon, Romuald, Stozek, Jolanta
• Primary Examiner(s): Willse, David H.
• Application Number:
  US08/146,033
• Time in Patent Office: 753 Days
• Field of Search: 112/103, 38/102.91, 38/102.2, 38/102.4, 38/102, 38/102.1, 623/2, 623/901
• US Class Current: 38/102.2
• 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: Y10S 623/901 Method of manufacturing prosthetic device

Abstract

An elastic textile covering is applied over an annular support of a heart valve prosthesis by inserting the preferably collar shaped textile covering through the annular support, turning two projecting axial ends of the textile covering over the outer surface of the annular support and then joining the two axial ends to each other to form a seam that preferably extends entirely around an outer periphery of the annular support. This seam can be concealed by a collar, which also may be covered by the textile covering. An apparatus for applying the textile covering to the annular support includes two coaxial annular rings into which the annular support and textile covering are inserted. Each of the rings includes structure for attachment to a respective axial end of the textile covering.

Claims

1. Apparatus for covering an annular support of a heart valve prosthesis with an elastic textile covering, said apparatus comprising:

two coaxial rings having a central opening for holding the annular support together with the covering, a first one of said two coaxial rings having a fastening means for engagement with one end of the textile covering; and

a second one of said two coaxial rings having a clamping device for engagement with the other end of the textile covering;

a stand attached to the first and second rings for holding the first and second rings in a predetermined position, said stand including guide columns slidably attached to said first and second rings for permitting said first and second rings to be moved along said guide columns while maintaining a relative position between said first and second rings.

2. The apparatus according to claim 1, wherein the opening of the first and second rings has dimensions larger than a diameter of said annular support so that a seam can be applied to the textile covering around the annular support inserted in said opening.

3. The apparatus according to claim 1, wherein the clamping device comprises a plurality of clamping elements distributed over a circumference of the second ring, each of said clamping elements being provided with a gripping element for gripping the textile covering.

4. The apparatus according to claim 3, wherein each of said gripping elements is a hook.

5. The apparatus according to claim 1, further comprising an adjusting means for adjusting the clamping force applied to the textile covering.

6. The apparatus according to claim 5, wherein said adjusting means includes a spring.

7. The apparatus according to claim 1, further comprising at least one ring clamping means for holding the first and second rings in a position clamping the textile covering.

8. The apparatus according to claim 1, further comprising an indicating means for indicating the clamping force applied to the textile covering.

9. The apparatus according to claim 1, wherein said stand includes a supporting base that is adjustable in height for holding the first and second rings at a desired height.