Biocompatible coated article

• US 5,738,902 A
• Filed: 10/10/1996
• Issued: 04/14/1998
• 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: Fisher, Harold, Voorhees, Marc, Forrestal, Lloyd
• Primary Examiner(s): CAMERON, ERMA C
• Application Number:
  US08/728,824
• Time in Patent Office: 551 Days
• Field of Search: 427/496, 427/498, 427/501, 427/503, 427/551, 427/552, 427/8, 427/9, 427/10, 427/2.12, 427/2.24, 427/2.25, 427/2.3, 427/2.31
• US Class Current: 427/2.12
• 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 method of coating a porous membrane with an polylactone-polysiloxane-polyactone triblock copolymer comprising the steps of contacting the membrane with a solution of the copolymer having a concentration of the copolymer, said concentration imparting to the membrane, when dry, a surface concentration of copolymer sufficient to provide an X-ray fluorescence relative intensity in the range 0.02 to 0.35.

2. A method according to claim 1 wherein the porous membrane is a polypropylene microporous membrane.

3. The method of claim 1 wherein the X-ray fluorescence relative intensity range is 0.05 to 0.25.

4. The method of claim 1 wherein the X-ray fluorescence relative intensity range is in the range 0.16 to 0.20.

5. A method according to claim 1 comprising the additional step of subjecting the coated membrane to ionizing radiation to produce an insoluble and adhering coating.

6. A method according to claim 5 wherein the ionizing radiation is in the form of x-rays, γ

-rays or an electron beam.

7. A method according to claim 5 wherein the radiation is x-rays in the dose range of 0.25 to 13.0 Mrad.

8. A method of coating a porous membrane with an polylactone-polysiloxane-polylactone triblock copolymer comprising passing said membrane through a solution of the copolymer at a constant rate, the solution having a concentration of the copolymer, said rate and concentration being such that, when dry, the membrane has a surface concentration of the copolymer sufficient to provide an X-ray fluorescence relative intensity in the range 0.02 to 0.35.

9. A method according to claim 8 wherein the porous membrane is a polypropylene microporous membrane.

10. The method of claim 8 wherein the X-ray fluorescence relative intensity range is 0.05 to 0.25.

11. The method of claim 8 wherein the X-ray fluorescence relative intensity range is in the range 0.16 to 0.20.

12. The method of claim 8 wherein the X-ray fluorescence relative intensity range is in the range 0.16 to 0.19.

13. The method of claim 8 wherein the rate is 100 ft/min and the copolymer concentration is 2% (w/w).

14. The method claim 8 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.

15. A method according to claim 8 comprising the additional step of subjecting the coated membrane to ionizing radiation to produce an insoluble and 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 0.25 to 13.0 Mrad.

18. A method of coating a porous membrane with a polylactone-polysiloxane-polylactone triblock copolymer comprising the steps of contacting the membrane with a solution of the copolymer having a concentration of the copolymer, said concentration imparting to the membrane, when dry, a surface concentration of copolymer sufficient to provide an X-ray fluorescence relative intensity in the range 0.1 to 0.25.

19. A method of coating a porous membrane with a polylactone-polysiloxane-polylactone triblock copolymer comprising passing said membrane through a solution of the copolymer at a constant rate, the solution having a concentration of the copolymer, said rate and concentration being such that, when dry, the membrane has a surface concentration of the copolymer sufficient to provide an X-ray fluorescence relative intensity in the range 0.1 to 0.25.

20. A method according to claim 19 wherein the porous membrane is a polypropylene microporous membrane.

21. The method of claim 19 wherein the X-ray fluorescence relative intensity range is 0.14 to 0.22.

22. The method of claim 19 wherein the X-ray fluorescence relative intensity range is in the range 0.16 to 0.20.

23. The method of claim 19 wherein the X-ray fluorescence relative intensity range is in the range 0.1690 to 0.19.

24. The method of claim 19 wherein the rate is 100 ft/min and the copolymer concentration is 2% (w/v).

25. The method of claim 19 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.