Stapled heart prosthesis and method of installing same

• US 6,241,765 B1
• Filed: 07/15/1999
• Issued: 06/05/2001
• Est. Priority Date: 07/15/1999
• Status: Expired due to Term

• Current Assignee: Corcym SRL (LivaNova Plc)
• Original Assignee: Sulzer Carbomedics Inc. (Zimmer Biomet Holdings, Inc.)
• Inventors: Alfaro, Arthur A., Griffin, Charles D.
• Primary Examiner(s): Willse, David H.
• Assistant Examiner(s): GHERBI, SUZETTE JAIME J
• Application Number:
  US09/353,677
• Time in Patent Office: 691 Days
• Field of Search: 523/2-1-, 523/2.38, 523/2.11
• US Class Current: 623/2.38
• CPC Class Codes: A61F 2/2403 with pivoting rigid closure members check valves with hinged closure members in general F16K15/03
• CPC Class Codes: A61F 2/2409 Support rings therefor, e.g. for connecting valves to tissue annuloplasty rings A61F2/2442
• CPC Class Codes: A61F 2/2427 Devices for manipulating or deploying heart valves during implantation

Abstract

A prosthetic heart valve is disclosed which has a rigid shoulder with staple receiving means. Using the staple receiving means of the shoulder, the heart valve may be secured within the heart by stapling the shoulder of the prosthesis to the patient'"'"'s tissue. Such a prosthesis is advantageous in that it may be secured in a much shorter time period than conventional valves thereby reducing the risks and complications of surgery.

Claims

1. A mechanical heart valve assembly, comprising:

a valve body;

a stiffening ring coupled to said valve body, said stiffening ring comprised of a body and a shoulder; and

at least one recess formed in said shoulder, said recess adapted for engaging at least one staple.

2. The mechanical heart valve assembly of claim 1, wherein said shoulder is formed integrally with said body of said stiffening ring.

3. The mechanical heart valve assembly of claim 1, wherein said shoulder and said body of said stiffening ring are physically separate components that are coupled to each other.

4. The mechanical heart valve assembly of claim 3, further comprising means for attaching said physically separate shoulder to said stiffening ring body.

5. The mechanical heart valve assembly of claim 1, wherein said at least one recess is a single continuous recess adapted to engage a plurality of staples.

6. The mechanical heart valve assembly of claim 1, wherein said at least one recess is one of a plurality of separate, non-continuous recesses.

7. The mechanical heart valve assembly of claim 1, wherein said shoulder has a surface and said at least one recess is a continuous recess formed in said surface of said shoulder.

8. The mechanical heart valve assembly of claim 1, wherein said shoulder has a surface and said at least one recess is comprised of a plurality of separate recesses formed in said surface of said shoulder.

9. The mechanical heart valve assembly of claim 1, further comprising a fabric covering positioned around said stiffening ring.

10. The mechanical heart valve assembly of claim 1, wherein said shoulder extends radially away from said body of said stiffening ring at an angle ranging from approximately 45 degrees to 135 degrees relative to said body.

11. The mechanical heart valve assembly of claim 1, wherein said shoulder has an upper surface and said at least one recess is formed in said upper surface of said shoulder.

12. The mechanical heart valve assembly of claim 1, wherein said shoulder has a lower surface and said at least one recess is formed in said lower surface of said shoulder.

13. A mechanical heart valve assembly, comprising:

a valve body;

a stiffening ring coupled to said valve body, said stiffening ring comprised of a body and a shoulder; and

a plurality of recesses formed in a surface of said shoulder, each of said recesses adapted for engaging at least one staple.

14. The mechanical heart valve assembly of claim 13, wherein said surface of said shoulder is an upper surface.

15. The mechanical heart valve assembly of claim 13, wherein said surface of said shoulder is a lower surface.

16. The mechanical heart valve assembly of claim 13, wherein said shoulder extends radially away from said body of said stiffening ring at an angle ranging from approximately 45 degrees to 135 degrees relative to said body.

17. A mechanical heart valve, comprising:

an annular valve body having an exterior annular groove on an outer surface;

an annular stiffening ring having a circumferential inner groove, said stiffening ring being circumferentially disposed about said valve body and having a body, an upper recess, a lower recess, and a shoulder extending in a radial direction from the body of the stiffening ring, said shoulder having a staple receiving means;

an upper capture ring disposed within said upper recess;

a lower capture ring disposed within said lower recess; and

a lock wire which is engaged between the exterior annular groove of the annular valve body and the circumferential inner groove of the stiffening ring.

18. The valve of claim 17, wherein the outside diameters of the stiffening ring, upper capture ring, and lower capture ring are within 10 percent of one another.

19. A mechanical heart valve assembly, comprising:

a valve body;

a stiffening ring coupled to said valve body, said stiffening ring comprised of a body and a shoulder; and

a plurality of openings in said shoulder, said openings adapted for receiving a fastener.

20. The device of claim 19, wherein said openings are generally circular.

21. The device of claim 19, wherein said fastener is a pin.

22. The device of claim 19, wherein said fastener is comprised of a pin having a head, a shaft, and a flexible barb.

23. The device of claim 19, wherein said shoulder has a thickness and said fastener has a length that is greater than the thickness of said shoulder.

24. The device of claim 19, wherein said openings extend completely through said shoulder.

25. A mechanical heart valve assembly, comprising:

a valve body;

a stiffening ring coupled to said valve body, said stiffening ring comprised of a body and a shoulder; and

a plurality of openings in said shoulder, said openings adapted for receiving a pin, said pin comprised of a shaft, a head, and a flexible barb.

26. The device of claim 25, wherein said openings are generally circular.

27. The device of claim 25, wherein said shoulder has a thickness and said pin has a length that is greater than the thickness of said shoulder.