| 摘要 |
Medical device for extracorporeal treatment of blood or plasma comprises a semipermeable membrane consisting of an anionic ("electronegative") polymer and a cationic protease inhibitor, the protease inhibitor being incorporated into at least part of the membrane by adsorption and/or ionic interaction before sterilisation of the device and before or after formation of the membrane. Also claimed are: (1) a process for producing a flat membrane by preparing a solution comprising an anionic polymer, a solvent and optionally a non-solvent, extruding the solution through a flat die, solidifying the membrane by contact with an inert liquid containing a cationic protease inhibitor, and washing the membrane; (2) a process for producing a flat membrane by preparing a solution comprising an anionic polymer, a solvent and optionally a non-solvent, extruding the solution through a flat die, solidifying the membrane by contact with an inert liquid, and washing the membrane with a solution containing a cationic protease inhibitor; (3) a process for producing a hollow fibre by preparing a solution comprising an anionic polymer, a solvent and optionally a non-solvent, extruding the solution to form a hollow fibre and simultaneously solidifying the hollow fibre by contact with an inert core liquid containing a cationic protease inhibitor, and washing the hollow fibre; (4) a process for producing a hollow fibre by preparing a solution comprising an anionic polymer, a solvent and optionally a non-solvent, extruding the solution to form a hollow fibre and simultaneously solidifying the hollow fibre by contact with an inert core liquid, and washing the hollow fibre with a solution containing a cationic protease inhibitor; (5) a process for producing a medical device for extracorporeal treatment of blood or plasma by mounting a flat membrane produced by process (1) or (2) or a bundle of hollow fibres produced by process (3) or (4) in a container; and (6) a process for producing a medical device for extracorporeal treatment of blood or plasma comprising a semipermeable membrane delimiting two compartments within a container, where the membrane consists of an anionic polymer, comprising forming a flat membrane or hollow fibre, mounting the membrane or a bundle of the hollow fibres in a container, contacting the semipermeable membrane with an acidic or neutral solution containing a cationic protease inhibitor, purging the solution from the device, and sterilising the device.
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