Biocompatible coated article

• US 5,702,823 A
• Filed: 10/10/1996
• Issued: 12/30/1997
• Est. Priority Date: 04/15/1994
• Status: Expired due to Term

• Current Assignee: Cobe Cardiovascular Incorporated (LivaNova Plc)
• Original Assignee: Cobe Cardiovascular Incorporated (LivaNova Plc)
• Inventors: Chen, Yung-Ming, Edrich, Richard A., Voorhees, Marc, Forrestal, Lloyd
• Primary Examiner(s): NAKARANI, DHIRAJLAL S
• Application Number:
  US08/728,823
• Time in Patent Office: 446 Days
• Field of Search: 427/384, 427/385.5, 427/388.1, 427/551, 428/447, 428/450, 428/458
• US Class Current: 428/450
• CPC Class Codes: A61L 27/34 Macromolecular materials
• CPC Class Codes: A61L 31/10 Macromolecular materials
• CPC Class Codes: A61L 33/068 obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds A61L33/062 takes precedence
• CPC Class Codes: B01D 67/0088 Physical treatment with compounds, e.g. swelling, coating or impregnation
• CPC Class Codes: C08L 67/04 Polyesters derived from hydroxycarboxylic acids, e.g. lactones C08L67/06 takes precedence
• CPC Class Codes: C08L 83/10 Block- or graft-copolymers containing polysiloxane sequences obtained by polymerising a compound having a carbon-to-carbon double bond on to a polysiloxane C08L51/08, C08L53/00
• CPC Class Codes: C09D 183/10 Block or graft copolymers containing polysiloxane sequences obtained by polymerising a compound having a carbon-to-carbon double bond on to a polysiloxane C09D151/08, C09D153/00
• CPC Class Codes: Y10T 428/249978 Voids specified as micro
• CPC Class Codes: Y10T 428/24998 Composite has more than two layers
• CPC Class Codes: Y10T 428/249992 Linear or thermoplastic
• CPC Class Codes: Y10T 428/31663 As siloxane, silicone or silane
• CPC Class Codes: Y10T 428/31667 Next to addition polymer from unsaturated monomers, or aldehyde or ketone condensation product
• CPC Class Codes: Y10T 428/31681 Next to polyester, polyamide or polyimide [e.g., alkyd, glue, or nylon, etc.]
• CPC Class Codes: Y10T 428/31786 Of polyester [e.g., alkyd, etc.]
• CPC Class Codes: Y10T 428/31797 Next to addition polymer from unsaturated monomers

Abstract

The biocompatibility of polymeric and metallic articles used in contact with blood can be substantially improved by coating the articles as described. The coating materials are triblock copolymers of the polylactone-polysiloxane-polylactone type. Optimum biocompatibility is provided by a coating of optimum surface concentration. Porous membranes can be coated as described, providing improved biocompatibility of blood oxygenators, hemodialyzers and the like.

Claims

1. A metallic article having a base metal and a biocompatible coating thereon comprising a polylactone-polysiloxane-polylactone triblock copolymer, said coating having a relative surface concentration sufficient to provide an X-ray fluorescence intensity ratio in the range 0.02 to 0.35.

2. A metallic article according to claim 1 wherein the X-ray fluorescence intensity ratio is the range 0.05 to 0.25.

3. A metallic article according to claim 1 wherein the X-ray fluorescence intensity ratio is in the range 0.09 to 0.18.

4. A metallic article according to claim 1 wherein said article is a flat-sheet heat exchanger or a membrane compartment.

5. A metallic article according to claim 4 wherein said article is stainless steel.

6. A metallic article according to claim 5 wherein said stainless steel is 316L.

7. A metallic article according to claim 1 wherein the triblock copolymer is a polycaprolactone-polysiloxane-polycaprolactone copolymer.

8. A metallic article according to claim 7 wherein the triblock copolymer comprises polycaprolactone blocks having each a nominal molecular weight in the range 1000 to 10,000 and a polysiloxane block having a nominal molecular weight in the range of 1000 to 5000.

9. A metallic article according to claim 8 wherein the triblock copolymer comprises polycaprolactone blocks having a nominal molecular weight of 2000 and a polysiloxane block having a nominal molecular weight in the range of 2000 to 3000.

10. A metallic article according to claim 1 wherein the biocompatible coating is subjected to ionizing radiation to produce an insoluble and tenaciously adhering coating.

11. A method of coating a metallic article with a polylactone-polysiloxane-polylactone triblock copolymer comprising the steps of contacting the article with a solution of the copolymer in a solvent capable of wetting the article, the solution having a specified concentration of the copolymer, said concentration imparting to the article, after drying, a surface concentration of copolymer sufficient to provide an X-ray fluorescence relative intensity in the range 0.02 to 0.35.

12. A method according to claim 11 wherein the metallic article is a stainless steel article.

13. A method according to claim 11 wherein the X-ray fluorescence relative intensity is in the range of 0.09 to 0.18.

14. A method according to claim 11 wherein the triablock copolymer has polycaprolactone blocks having a nominal molecular weight of 2000 and a polysiloxane block having a nominal molecular weight in the range of 2000 to 3000 and the solvent is methyl ethyl ketone.

15. A method according to claim 11 comprising the additional step of subjecting the article having a surface coating of the copolymer to ionizing radiation to produce an insoluble and tenaciously adhering coating.

16. A method according to claim 15 wherein the ionizing radiation is in the form of x-rays, γ

-rays or an electron beam.

17. A method according to claim 15 wherein the radiation is x-rays in the dose range of 0.35 to 13.0 Mrad.

18. A method of coating a metallic article with a polylactone-polysiloxane-polylactone triblock copolymer comprising contacting said article with a solution of the copolymer in a solvent capable of wetting the article, the solution having a specified concentration of the copolymer, said concentration being such that, after drying, the article has a surface concentration of the copolymer sufficient to provide an X-ray fluorescence relative intensity in the range of 0.05 to 0.25.

19. A method according to claim 18 wherein the metallic article is a stainless steel article.

20. A method according to claim 19 wherein the X-ray fluorescence relative intensity is in the range of 0.09 to 0.18.

21. A method according to claim 18 wherein the triblock copolymer has polycaprolactone blocks having a nominal molecular weight of 2000 and a polysiloxane block having a nominal molecular weight in the range of 2000 to 3000 and the solvent is methyl ethyl ketone.

22. A method according to claim 18 comprising the additional step of subjecting the article having a surface coating of the copolymer to ionizing radiation to produce an insoluble and tenaciously adhering coating.

23. A method according to claim 22 wherein the ionizing radiation is in the form of x-rays, γ

-rays or an electron beam.

24. A method according to claim 22 wherein the radiation is x-rays in the dose range of 0.25 to 13.0 Mrad.