Biocompatible medical articles and process for their production

• US 20030059631A1
• Filed: 09/23/2002
• Published: 03/27/2003
• Est. Priority Date: 11/29/1999
• Status: Active Grant

• Current Assignee: Bayer Materialscience AG (Covestro AG)
• Original Assignee: Phylogenetix Laboratories, Inc.
• Inventors: Al-Lamee, Kadam Gayad
• Granted Patent: US 6,756,125 B2
• Time in Patent Office: Days
• US Class Current: 428/448
• CPC Class Codes: A61L 29/085 Macromolecular materials
• CPC Class Codes: A61L 31/10 Macromolecular materials
• CPC Class Codes: A61L 33/0017 using a surface active agent
• CPC Class Codes: A61L 33/0029 using an intermediate layer of polymer
• CPC Class Codes: C08L 83/04 Polysiloxanes
• CPC Class Codes: Y10T 428/31663 As siloxane, silicone or silane

Abstract

An article of metal, glass, ceramics or plastics having a surface for contact with tissue or with circulating blood, has a surface coating of an organopolysiloxane and heparin, in which coating the organopolysiloxane is adherent to the surface of the article and has cationic groups that form ionic bonds with anionic groups of the heparin. The surface for contact with circulating blood may be an interior surface of a cannula or tubing or of a blood oxygenator or it may be a working surface of a blood filter. The polymer may be poly-[dimethylsiloxane-co-methyl-(3-hydroxypropyl)siloxane]-graft-poly(ethylene glycol) [3-(trimethylammonio) propyl chloride] ether. A method is also provided for forming a coated article as aforesaid, said method comprising contacting said surface with a solution in a volatile organic solvent of an organopolysiloxane and with heparin, the organopolysiloxane being adherent to the surface of the article and having cationic groups that form ionic bonds with the anionic groups of the heparin, and removing said volatile solvent.

Claims

1. An article having a surface for contact with circulating blood, said surface having a coating of an organopolysiloxane and heparin, wherein the organopolysiloxane is adherent to the surface of the article and has cationic groups that form ionic bonds with anionic groups of the heparin.

2. The article of claim 1, which is at least partly of a metal, ceramic or glass.

3. The article of claim 1 or 2, which is at least partly of a polymeric material.

4. The article of claim 3, wherein the article is of polyethylene, polyacrylic, polypropylene, polyvinyl chloride, polyamide, polyurethane, polyvinyl pyrrolidone, polyvinyl alcohol, polystyrene, polytetrafluoroethylene, polyester, silicone rubber, natural rubber, polycarbonate or a hydrogel.

5. The article of any preceding claim which is hollow and in which the surface for contact with circulating blood is an interior surface.

6. The article of any preceding claim, which is a cannula or tubing.

7. The article of any of claims 1-5, which is a blood oxygenator, blood filter or haemodyalyser.

8. The article of any preceding claim, wherein the organopolysiloxane is adherent without a coupling agent.

9. The article of any preceding claim, wherein the organopolysiloxane is soluble in an alcohol.

10. The article of any preceding claim, wherein the organopolysiloxane has trimethylammonium groups.

11. The article of any preceding claim, wherein the organopolysiloxane has cationic groups linked to a polydimethylsiloxane main chain by grafted polyoxyethylene chains.

12. The article of claim 11, wherein the grafted polyoxyethylene chains include hydroxyl terminated chains and quaternary ammonium terminated chains.

13. The article of any preceding claim, wherein the polymer is poly-[dimethylsiloxco-methyl-(3-hydroxypropyl)siloxane]-graft-poly(ethylene glycol) [3-(trimethylammonio) propyl chloride] ether.

14. A method for forming a coated article as defined in any preceding claim, said method comprising contacting said surface with a solution in a volatile organic solvent of an organopolysiloxane and with heparin, the organopolysiloxane being adherent to the surface of the article and having cationic groups that form ionic bonds with the anionic groups of the heparin, and removing said volatile solvent.

15. The method of claim 14, wherein the surface of the article is coated sequentially with the organopolysiloxane and with heparin.

16. The method of claim 14, wherein a complex of the organopolysiloxane and alcohol is formed in solution and the solution is contacted with the surface of the article.

17. The method of claim 14, 15 or 16, wherein organopolysiloxane is contacted with the surface of the article whilst in solution in an alcohol.

18. The method of claim 17, wherein the alcohol is 2-propanol.

19. The method of any of claims 14-18, wherein the surface to be treated is one face of a membrane or tube of microporous material, gas under pressure being supplied to the other face of the membrane or tube.

20. An article having a surface for contact with circulating blood, said surface having a coating of an organopolysiloxane and a biologically active material having anionic groups, wherein the organopolysiloxane is adherent to the surface of the article and has cationic groups that form ionic bonds with anionic groups of the biologically active material.

21. The article of claim 20, wherein the biologically active molecule is a diagnostic agent, growth factor, or antibody, prostaglandin or protein.

22. Use of an article according to any of claims 1-13 in the re-circulation of blood.

23. A method for forming a coated article substantially as described in any of the examples.