Articles exhibiting a biocompatible surface layer

Stock material or miscellaneous articles – Hollow or container type article – Polymer or resin containing

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Details

428414, 428415, 428416, 428429, 428447, 428532, 604280, 604408, B32B 108, B32B 2304, B32B 2738

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active

045886245

DESCRIPTION:

BRIEF SUMMARY
The present invention relates to articles exhibiting a biocompatible surface layer and a process for providing articles with such a surface layer. More particularly, the invention relates to articles exhibiting at least one surface of glass, silicon, aluminum or silicone rubber coated with a biocompatible surface layer and a process for providing articles exhibiting at least one surface of glass, silicon, aluminum or silicone rubber with a biocompatible surface layer.
The object of the present invention is to provide articles useful within medicine with a biocompatible surface layer. This means, for instance for articles intended for use in contact with blood, that the article which is alien to the blood is treated in such a way that it does not induce coagulation or formation of thromboses.
Prior art techniques to provide articles useful in medicine with a biocompatible surface layer often comprise an alteration in the surface energy of the material. An improvement in the properties of various materials has been obtained by modifying the surface layers either to a more hydrophobic character or to a more hydrophilic character. Hydrophobization of the surface layer, for instance by the methylization of a glass surface, results in a decrease in the effectiveness of the surface activated coagulation system of the blood. However, proteins such as fibrinogen are bound comparatively firmly to such surfaces and to this protein layer certain cells, the thrombocytes, can be bound and activated whereafter coagulation is started even though it proceeds slowly. Hydrophilic surfaces, e.g. hydrolysed nylon or oxidized aluminium, have presented reduced binding of cells but the surface activated coagulation system is not prevented at these surfaces. The use of these surfaces in contact with blood thus implies the addition cf anticoagulants, for instance heparin, to the blood.
Another prior art surface treatment technique for preventing coagulation comprises binding of anticoagulants into the surface layer. Heparin has primarily been used with this technique. Heparin is a hexoseaminehexuronic acid polysaccharide which is sulphatized and has acid properties, i.e. heparin is an organic acid. According to DE-A-21 54 542 articles of an organic thermoplastic resin are first impregnated with an aminosilane coupling agent and the articles thus treated are then reacted with an acid solution of a heparin salt to the binding of heparin in the surface layer by means of ionic bonds. Surfaces thus treated with heparin have proved to reduce the coagulation reaction. A considerable disadvantage of these surfaces, however, is that the heparin treatment does not prevent the adherence of thrombocytes, which is a great problem in, for instance, heart-lung machines.
It is also known that water-binding gels, for instance polyhydroxyalkyl methacrylate, reduce the adsorption of proteins and present a low adhesiveness to cells (Hoffman et al. Ann. New York Acad. Sci., Vol. 283 (1977) 372). These properties are considered to be due to the fact that gels containing water give a low surface energy in the interface to the blood. The prior art technique for manufacturing of water-binding gels, however, is impaired by disadvantages such as complicated preparation technique and incomplete polymerisation, which results in leakage cf topic monomers. A gel-like mixture of saccharose and glycose included in a matrix of the polysaccharide dextran or dextrin is used in accordance with previously known technique as a tube for the connection of blood-vessels. This mixture should have the effect that no toxicity to the patient occurs and that the implantate is dissolved in the blood after some time. It is known that the neutral polysaccharide dextran is miscible with blood without provoking any coagulation reaction.
The present invention combines the property of water-binding gels with the low toxicity of polysaccharides at the same time as it affords a technique for the surface treatment of materials important for medical technology, such as glass, silicon, alu

REFERENCES:
patent: 3434869 (1969-03-01), Davidson
patent: 3683926 (1972-08-01), Suzuki
patent: 3755218 (1973-08-01), Yen et al.
patent: 3766104 (1973-10-01), Bonin et al.
patent: 3810781 (1974-05-01), Eriksson et al.
patent: 3846353 (1974-11-01), Grotta
patent: 4118845 (1978-10-01), Eriksson et al.
Chemical Abstract, vol. 83, No. 10, p. 369 No. 84823v, "Semibiological Dextran--Torlen Vascular Prostheses".

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