METHOD OF PRODUCING BIOLOGICAL TISSUE FOR SURGICAL IMPLANTATION Russian patent published in 2024 - IPC A61L27/36 A61L27/50 A61F2/02 

FIELD: biotechnology; chemistry.

SUBSTANCE: group of inventions relates to a method of treating biological tissue, consisting of the following steps: (1) soaking biological tissue treated with a cross-linking agent in a saline solution; (2) contacting the soaked biological tissue with an aqueous solution of hydrogen peroxide; (3) contacting biological tissue with an aqueous solution containing PBS and EDTA, where PBS denotes phosphate buffered saline having pH of 7.4 and containing an aqueous saline solution of sodium dihydrophosphate, sodium chloride and, if necessary, potassium chloride and potassium dihydrophosphate, and EDTA denotes ethylenediaminetetraacetic acid, which is a complexing and chelating agent capable of binding metal ions, especially metal ions, Fe²⁺/Fe³⁺, Al³⁺, Mg²⁺, Ca²⁺, Mn²⁺, Zn²⁺ and the like, and remove them from the solution, forming EDTA complexes, (3a) contacting the biological tissue with ethanol in concentration of 70% by volume; (4) contacting biological tissue with a solution comprising glycerol, ethanol and EDTA, where the volume ratio of glycerol:ethanol at step (4) is from 1:5 to 5:1, (5) contacting the biological tissue with a glycerol solution, (5a) contacting the biological tissue with ethanol at concentration of 70% by volume; (6) drying biological tissue; (7) placing biological tissue in package; (8) sealing the package; (9) sterilizing the package; wherein the cross-linking agent is glutaric aldehyde, and biological tissue is bovine or porcine pericardium, or cardiac valve, wherein EDTA at steps (3) and (4) has concentration of 0.01 to 10.0 wt.%, and hydrogen peroxide at step (2) has concentration of 0.05 to 5.0% by volume, also refers to biological tissue with anti-calcification properties in a ready-to-use form for surgical implantation treated with an aqueous solution containing PBS and EDTA, as well as a solution containing glycerol, ethanol and EDTA, according to the method according to any one of claims 1-6, returned to a size of at least 95% of its initial hydrated form, which is bovine or porcine pericardium, or heart valve, and also relates to the use of biological tissue as a bioprosthesis and in transcatheter heart valves.

EFFECT: group of inventions provides an effective method of imparting anti-calcification properties to biological tissues used for surgical implantation, which is not accompanied by a destructive effect, and also provides improved mechanical characteristics of the biological tissue during storage.

9 cl, 13 dwg, 4 tbl, 8 ex