# US 5,702,823 A · Biocompatible coated article

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- Number: US 5,702,823 A
- Document ID: US5702823A
- Status: Granted
- Kind: A
- Application number: 08/728,823
- Filed: 1996-10-10
- Granted: 1997-12-30
- Earliest claimed: 1994-04-15
- Assignees: Cobe Laboratories, Inc.
- Inventors: Lloyd Forrestal; Marc Voorhees; Yung-Ming Chen; Richard A. Edrich
- Web page: https://patentgrep.com/patent/US5702823A

## CPC

- B01D 67/0088: {Physical treatment with compounds, e.g. swelling, coating or impregnation}
- A61L 27/34: Macromolecular materials
- A61L 31/10: Macromolecular materials
- A61L 33/068: {obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds (A61L33/062 takes precedence)}
- 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)
- Y10T 428/249978: Voids specified as micro
- Y10T 428/24998: Composite has more than two layers
- Y10T 428/249992: Linear or thermoplastic
- Y10T 428/31663: As siloxane, silicone or silane
- Y10T 428/31667: Next to addition polymer from unsaturated monomers, or aldehyde or ketone condensation product
- Y10T 428/31681: Next to polyester, polyamide or polyimide [e.g., alkyd, glue, or nylon, etc.]
- Y10T 428/31786: Of polyester [e.g., alkyd, etc.]
- Y10T 428/31797: Next to addition polymer from unsaturated monomers
- B01D: SEPARATION (separating solids from solids by wet methods B03B, B03D; by pneumatic jigs or tables B03B; by other dry methods B07; magnetic or electrostatic separation of solid materials from solid materials or fluids, separation by high-voltage electric fields B03C; centrifuges, vortex apparatus B04; presses per se for squeezing-out liquid from liquid-containing material B30B9/02; treatment of water C02F, e.g. softening by ion-exchange C02F1/42; {arrangements of air intake cleaners in gas turbine plants F02C7/05} ; arrangements or mounting of filters in air-conditioning, air-humidification or ventilation F24F13/28)
- A61L: METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES (preservation of bodies or disinfecting characterised by the agents employed A01N; preserving, e.g. sterilising, food or foodstuffs A23; preparations for medical, dental or toiletry purposes A61K)
- C09D: COATING COMPOSITIONS, e.g. PAINTS, VARNISHES OR LACQUERS; FILLING PASTES; CHEMICAL PAINT OR INK REMOVERS; INKS; CORRECTING FLUIDS; WOODSTAINS; PASTES OR SOLIDS FOR COLOURING OR PRINTING; USE OF MATERIALS THEREFOR (cosmetics A61K; processes for applying liquids or other fluent materials to surfaces, in general, B05D; staining wood B27K5/02; glazes or vitreous enamels C03C; natural resins, French polish, drying-oils, driers, turpentine, per se, C09F; polishing compositions other than French polish, ski waxes C09G; adhesives or use of materials as adhesives C09J; materials for sealing or packing joints or covers C09K3/10; materials for stopping leaks C09K3/12; processes for the electrolytic or electrophoretic production of coatings C25D)
- Y10T: TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION

## 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

### Claim 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.

### Claim 2 (depends on 1)

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

### Claim 3 (depends on 1)

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

### Claim 4 (depends on 1)

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

### Claim 5 (depends on 4)

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

### Claim 6 (depends on 5)

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

### Claim 7 (depends on 1)

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

### Claim 8 (depends on 7)

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.

### Claim 9 (depends on 8)

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.

### Claim 10 (depends on 1)

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

### Claim 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.

### Claim 12 (depends on 11)

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

### Claim 13 (depends on 11)

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

### Claim 14 (depends on 11)

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.

### Claim 15 (depends on 11)

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.

### Claim 16 (depends on 15)

A method according to claim 15 wherein the ionizing radiation is in the form of x-rays, .gamma.-rays or an electron beam.

### Claim 17 (depends on 15)

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

### Claim 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.

### Claim 19 (depends on 18)

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

### Claim 20 (depends on 19)

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

### Claim 21 (depends on 18)

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.

### Claim 22 (depends on 18)

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.

### Claim 23 (depends on 22)

A method according to claim 22 wherein the ionizing radiation is in the form of x-rays, .gamma.-rays or an electron beam.

### Claim 24 (depends on 22)

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