Coating process

Coating processes – Medical or dental purpose product; parts; subcombinations;... – Implantable permanent prosthesis

Patent

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Details

427338, 427322, 427414, 427 213, 427307, B05D 310, A61F 216

Patent

active

058856471

DESCRIPTION:

BRIEF SUMMARY
The present invention relates to a process for the coating of intraocular lenses for the purpose of imparting tissue compatibility to said lenses.


BACKGROUND OF THE INVENTION

Any surface of a non-biological origin initiates a sequence of unwanted reactions when brought into contact with living tissue or blood. The most well known reactions are those generated by the blood-contacting materials that activate the platelets and the plasma coagulation system leading the formation of a thrombus. Foreign surfaces in living tissue activate the complement and the mononuclear cellsystems, thereby creating inflammatory reactions.
Although the present invention is based on the use of polysaccharides selected from heparin, heparan sulphate and chondroitin sulphate for the purpose of providing stable, biocompatible coatings on intraocular eye lenses, the following discussion and disclosure will be mainly directed to heparin or heparan sulphate. However, it is important to note that the invention is not restricted to these two polysaccharides.
Inmobilisation of the blood-anticoagulant, heparin, to artificial, blood-contacting materials has proven to be a successful approach for achieving a thromboresistant surface suitable for short term use (days and weeks). In tis procedure, the structure characteristics of the endothelial lining of the vascular wall are mimiced by end-point attachment of heparin to the surface.
The surface, prepared by end-point attachment of heparin to a polyamine has the following properties: 1) it is nonthrombogenic, 2) it does not activate the complement system, 3) it does not activate the mononuclear cell system, 4) it adheres and stabilizes growth factors and 5) in general it adheres cells to a much lower extent than other surfaces.
Examples on other products where biocompatible coatings are desired are eye lenses, breast implants, vascular grafts, hip joints etc. The surface in question is excellent also for blood contacting materials.
There are several publications that have described the antiproliferative effect of heparin and heparan sulphate on a number of different cells (smooth muscle cells, epithelial cells). In other publications the growth factor stabilizing and activating effect of heparin has been described.
It is now generally agreed that low molecular weight heparin (less than about 2500 D) inhibits cell growth, whereas high molecular weight heparin (higher than about 6000 D) stimulates cell growth.


SUMMARY OF THE INVENTION

The main object of the present invention is to provide a new process for the coating of intraocular lenses to impart tissue compatibility to such lenses.
Another object of the invention is to provide a process for forming a stable coating on intraocular lenses.
A further object of the invention is to provide a process for the attachment of biologically active polysaccharides to the surface of intraocular lenses in such a manner as to inhibit substantial cell growth.
For these and other purposes that will be clear from the following disclosure the invention provides for a process for the coating of an intraocular lens for the purpose of imparting tissue compatibility thereto. Said process involves the following steps: periodate-oxidized polysaccharide selected from heparin, heparan sulphate, and chondroitin sulphate to stabilize said polyamine by covalent and/or ionical crosslinking; polyamine; and periodate-oxidized polysaccharide selected from heparin, heparan sulphate, and chondroitin sulphate in the presence of a cyancborohydride to convert formed labile Schiff's bases to stable secondary amines.
In the instant disclosure the expression "Polyamine" is intended to cover arm polyamines, including amine-containing polysaccharides, such as chitosan. Chitosan is a linear, 1,4-linked polysaccharide composed of .beta.-D-glucoseamine units of which some are N-acetylated. Chitosan is made by N-deacetylation of chitin, a polymer present in the shell of inter alia insects and crayfish. The degree of N-deacetylation can be controlled by hydrolysis with the use of a

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"A New Method for Covalent Coupling of Heparin and Other Glycosaminoglycans to Substances Containing Primary Amino Groups", James Hoffman et al., Carbohydrate Research, 117, (1983) pp. 328-331.

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