A method of manufacturing a heart valve made of a polymer material and heart valve obtained in this way

摘要

A method for manufacturing a heart valve made of a polymer material (9), comprising the steps of: a) providing a shaped mold (16) for replicating the profile to be provided to the valve (9); b) inserting an annular support (10) on the mold (16), so that the mold and support assembly forms a former (24); c) providing an apparatus (22) for depositing a polymer material on the former, comprising a pair of spray guns (28) disposed transversely to a longitudinal axis of the former (A); d) rotating the former (24) on the longitudinal axis (A); e) separately feeding a spray gun with a polymer solution comprising: (i) a copolymer containing an intra-chain silicone, such as polydimethylsiloxane (PDMS) and a polymer selected from the group consisting of a poly (carbonate-urethane) fluorinated (F-PCU), a polycarbonate-urethane (PCU), a polyether-urethane (PEtU), a polyurethane-urea (PUR), a polycaprolactone (PCL); (ii) an extracatenary functionalized PDMS, terminating in two diacetoxysilyl groups, which can be crosslinked by itself thereby forming a semi-interpenetrating polymer network (semi-IPN) with the copolymer (i); and (iii) a solvent; and the other spray gun with a non-solvent compound for the polymer solution, said non-solvent compound being selected from the group comprising water, alcohols and mixtures thereof, to generate two jets (30) which are interspersed throughout. a direction substantially transverse to said longitudinal axis (A); f) keeping the jets (30) focused on one or more sections of the lateral surface (20a) of the former until the desired parameters of thickness and distribution of the polymer on the lateral surface (20a) of the former are met; g) directing the jets (30) so that they strike against a front surface (20b) of the former (24); h) maintaining the jets (30) focused frontally against the former, until the desired parameters of thickness and distribution of the polymer are met throughout the front surface (20b) of the former; i) remove traces of residual solvents; l) inserting the former into an outer mold (42) comprising outer mold modules (48); m) radially compressing the former (24) in the modules (48), continuing to exert the compression force during the subsequent stages of the procedure; n) heating the outer mold (42) containing the former (24) until the crosslinking of the polymer material deposited on the former is completed; o) removing the excess material from the polymer valve (9); p) opening the mold (48), removing the radial compression force of the outer mold (48) against the former (24) and removing the former (24) from the outer mold (42); and q) removing the polymer valve (9), including the support ring (10), from the mold (16).