NANO-COMPOSITE LAYER BASED ON COLLAGEN NANO-FIBERS AND ITS PRODUCTION METHOD Russian patent published in 2021 - IPC A61C13/09 A61L27/34 A61L27/50 A61L27/58 B82B3/00 

FIELD: medicine.

SUBSTANCE: invention relates to a biologically active nano-composite layer based on collagen nano-fibers for application to orthopedic and dental implants based on metals or metal alloys, an orthopedic or dental implant based on metal or metal alloys and a method for producing the specified layer. The biologically active nano-composite layer contains nano-fibers with an average diameter of 100-350 nm. Nano-fibers contain from 5 to 15 wt.% of antibiotic, polyethylene oxide in the amount of no more than 1 wt.% and I type collagen for the rest. The orthopedic or dental implant contains coating with the specified nano-composite layer on at least part of its surface. The method for producing the layer includes following stages: I type collagen and polyethylene oxide medium-viscosity molecular weight in the range from 400'000 to 900'000, wherein the ratio of polyethylene oxide to collagen is from 0.05 to 0.11, are mixed with phosphate buffer to obtain a collagen concentration in a mixture from 5 wt.% to 11 wt.%. Then, the obtained mixture is held for at least 60 hours at a temperature in the range from 32°C to 42°C. Next, homogenization of the mixture is carried out by mixing with simultaneous addition of ethanol with final volume ratio of phosphate buffer to ethanol from 1:1 to 1:2, after which electrostatic molding is carried out from the mixture of the nano-composite layer, which is hardened by means of immersion in an alcohol solution in water with an alcohol concentration of 95 wt.% with the addition of hydrochloride of N-(3-dimethylaminopropyl)-N ethylcarbodiimide and N-hydroxysuccinimide. The weight of hydrochloride of N-(3-dimethylaminopropyl)-N ethylcarbodiimide per 1 g of molded collagen is at least 0.625 g, and the weight of N-hydroxysuccinimide per 1 g of molded collagen is at least 0.156 g. The amount of the alcohol solution in water with an alcohol content of 95 wt.% is at least 140 ml per 1 g of molded collagen. Then, the layer is washed with a saline solution or phosphate buffer and then with water with the following drying. Next, the layer is impregnated with antibiotic.

EFFECT: obtaining the nano-composite layer reproducing the content and structure of a real bone as much as possible, so that it contains only collagen and calcium phosphate/hydroxyapatite, which provides for an improvement of osteo-inductive properties of an implant surface layer.

8 cl, 5 dwg, 3 ex