Surfactant treatment of implantable biological tissue to inhibit calcification

• US 5,215,541 A
• Filed: 03/18/1985
• Issued: 06/01/1993
• Est. Priority Date: 11/12/1982
• Status: Expired due to Term

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Baxter International Inc.
• Inventors: Ahmed, Ahmed I., Nashef, Aws S.
• Primary Examiner(s): Willis, Jr., Prince
• Assistant Examiner(s): MCNALLY, JOHN
• Application Number:
  US06/713,204
• Time in Patent Office: 2,997 Days
• Field of Search: 8/94.11, 8/1, 3/1.4, 3/1.5, 424/333, 424/334, 623/1, 623/2, 623/3
• US Class Current: 128/898
• 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: A61L 27/50 Materials characterised by their function or physical properties , e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
• CPC Class Codes: Y10S 623/922 Heart

Abstract

A process for the preparation of implantable biological tissue, and in particular bioprosthetic heart valves, which are prone to calcification after implantation. The process includes the treatment of tissue with an effective amount of a surfactant to reduce calcification of the implanted tissue.

Claims

1. A method for reducing calcification of biological tissue after implantation in an animal comprising:

fixing the biological tissue under tissue fixing conditions; and

contacting the biological tissue with a solution of an anionic surfactant prior to implantation in an amount effective in reducing calcification of the tissue after implantation;

wherein the surfactant is selected from the group consisting of ethylene oxide sulfates of aliphatic alcohols, sulfates of alkylphenols, alkane sulfonic acids, alkylaryl sulfonic acids, salts of bile acids, salts of fatty acids, N-alkanoyl amino acids, N-acylated amino acids, sulfated ethanol amides, sulfated alkylphenol ethers, and salts thereof.

2. The process of claim 1 wherein the surfactant is the sodium, potassium or ammonium salt.

3. The process of claim 1 wherein the tissue is contacted with the surfactant during fixation.

4. The process of claim 1 wherein the tissue is contacted with the surfactant during post-fixation sterilization.

5. The process of claim 1 wherein the amount of surfactant in the solution is from about 0.1 to about 10 weight percent.

6. The process of claim 5 wherein the tissue is contacted with the surfactant solution for a time from about 2 to about 30 hours.

7. The process of claim 1 wherein the amount of surfactant in the solution is from 0.5 to about 5 weight percent.

8. The process of claim 1 wherein the tissue is fixed with glutaraldehyde.

9. The process of claim 1 wherein the tissue is fixed with glutaraldehyde;

and is contacted with a solution having from about 0.1 to about 10 weight percent of surfactant selected from the group consisting of ethylene oxide sulfates of aliphatic alcohols, sulfates of alkylphenols, alkane sulfonic acids and alkylaryl sulfonic acids.

10. The process of claim 1 wherein the biological tissue is tendon, ligament, heart valve, dura mater, or pericardium.

11. The process of claim 1 wherein the amount of surfactant in the solution is from about 0.1 to about 1.5 weight percent;

the biological tissue is tendon, ligament, heart valve, dura mater, or pericardium, and is fixed with glutaraldehyde;

the surfactant is N-lauroylsarcosine; and

the tissue is contacted with the surfactant solution for a time from about 6 to about 24 hours at a pH of from about 7.0 to about 7.6.

12. The process of claim 1 wherein the tissue is contacted with surfactant during post-fixation sterilization and the surfactant solution further comprises from about 4 to about 5 percent formaldehyde.