Method for inhibiting mineralization of natural tissue during implantation

• US 4,323,358 A
• Filed: 04/30/1981
• Issued: 04/06/1982
• Est. Priority Date: 04/30/1981
• Status: Expired due to Term

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Vascor, Inc.
• Inventors: Lentz, David J., Pollock, Elisabeth M.
• Primary Examiner(s): Tungol, Maria Parrish
• Application Number:
  US06/259,762
• Time in Patent Office: 341 Days
• Field of Search: 8/94.11, 3/1, 3/1.4, 3/1.5
• US Class Current: 8/94.11
• 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: A61L 2400/02 Treatment of implants to prevent calcification or mineralisation in vivo
• CPC Class Codes: A61L 27/3687 characterised by the use of chemical agents in the treatment, e.g. specific enzymes, detergents, capping agents, crosslinkers, anticalcification agents
• CPC Class Codes: Y10S 623/916 Blood vessel

Abstract

Natural tissues fixed with a tanning solution such as glutaraldehyde and intended for implantation in humans, e.g., porcine heart valve prosthetic devices, are treated with a solution of a water soluble salt of a sulfated higher aliphatic alcohol such as sodium dodecyl sulfate to inhibit mineralization, particularly calcification, of the tissue after implantation.

Claims

1. A method for inhibiting the mineralization of fixed natural tissue after implantation in a living body comprising contacting fixed natural tissue intended for implantation with an aqueous solution of a water soluble salt of a C_7-18 alkyl sulfate.

2. The method of claim 1 wherein the aqueous solution is buffered to a pH of 4.0 to 9.0.

3. The method of claim 1 wherein the water soluble salt is selected from the group consisting of sodium, potassium, ammonium and amine salts.

4. The method of claim 1 wherein the C_7-18 alkyl is a straight chain aliphatic group.

5. The method of claim 1 wherein C_7-18 alkyl is a branched aliphatic group.

6. The method of claim 1 wherein C_7-18 alkyl sulfate is selected from the group consisting of lauryl, myristyl, cetyl, steryl and oleyl sulfate.

7. The method of claim 1 wherein said natural tissue is contacted with said salt of C_7-18 alkyl sulfate for a time sufficient to effectively inhibit future calcification of said tissue after implantation.

8. The method of claim 7 wherein said tissue is contacted with said salt of C_7-18 alkyl sulfate for a period of at least 4 hours at room temperature.

9. The method of claim 1 wherein the concentration of said salt of C_7-18 alkyl sulfate in said solution is from about 0.1 to 5% by weight.

10. The method of claim 9 wherein the solution is buffered to a pH of 7.0 to 7.5.

11. A method for inhibiting the calcification of fixed natural tissue after implantation in a living body which comprises contacting fixed tissue intended for implantation with a solution comprising sodium dodecyl sulfate for a time sufficient to effectively inhibit future calcification of said tissue after implantation.

12. The method of claim 11 wherein said solution comprises from about 0.1 to 5% by weight sodium dodecyl sulfate.

13. The method of claim 11 wherein said tissue is contacted with said solution for a time of at least about 4 hours.

14. The method of claim 11 wherein said solution is buffered to a pH of from about 7.0 to 7.5.

15. The method of claim 11 wherein the solution is buffered to a pH of about 7.4 with about 0.005 M N-2-hydroxyethylpiperazine-N'"'"'-2-ethanesulfonic acid.

16. The method of claim 15 wherein the concentration of sodium dodecyl sulfate is about 1%.

17. The method of claim 16 wherein the tissue is contacted with said solution of sodium dodecyl sulfate for a period of about 24 hours at ambient temperature.

18. The method of claim 11 wherein the fixed tissue is a glutaraldehyde-fixed porcine heart valve.

19. The method of claim 11 wherein said living body is a human.