METHOD FOR INDIVIDUAL ASSESSMENT OF BIOCOMPATIBILITY WITH ORGANISM OF IMPLANTED POLYMER MATERIALS Russian patent published in 2021 - IPC A61B10/00 G01N33/49 G01N33/68 G01N33/15 

FIELD: medicine.

SUBSTANCE: invention refers to medicine, namely to immunology, implantology, surgery, and can be used for individual assessment of biocompatibility with an organism of implanted polymer materials. Investigated material is sampled from an individual. Patient's blood sample is sampled in a preimplantation period, the blood is centrifuged to produce a mononuclear leukocyte population. Obtained cell suspension is introduced into the wells of a plate with samples of implanted polymer materials in the form of cylinders 3 mm long and 1 mm in diameter, in amount of 1 piece per well of a round-bottomed plate, incubated at 5% CO₂ for 72 hours at 37°C. Further, the number of mononuclear leukocytes and the concentration of the pro-inflammatory cytokines are determined: IL-1β and IL-8. Derived values are expressed in the form of a stimulation index which is calculated by formula: SI=SP/SG, pre-calculating specific production of cytokine in presence of polymer sample and in presence of glass by formulas: SP=C/LC_C, SG=G/LC_G, where SP is specific production of cytokine in presence of polymer sample, pg/cell; C is cytokine concentration in sample with polymer sample, pg/ml; LC_C is the number of mononuclear leukocytes in a sample with a polymer sample in 1 ml; SG is specific production of cytokine in presence of glass, pg/cell; G is cytokine concentration in sample with glass sample, pg/ml; LC_G is the number of mononuclear leukocytes in the sample with glass in 1 ml; SI is the stimulation index. If the stimulation index exceeds 1, low biocompatibility with the organism of such polymeric material and a high probability of developing complications during implantation are stated.

EFFECT: method enables individual assessment of the biocompatibility of the polymer material from which the implant is made, for a specific patient by using a population of mononuclear leukocytes of peripheral venous blood of a specific individual and testing their reaction to the polymer by determining the stimulation index as the ratio of the specific production of the main pro-inflammatory cytokines IL-1β and IL-8 in sample with polymer sample to specific production of same cytokines in sample with glass.

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