Abstract: A blood purification device includes a porous molded body containing an inorganic ion-adsorbing material and is characterized by the following: the concentrations of Mg, Al, Ti, V, Cr, Mn, Fe, Ni, Cu, Zn, Ga, Rb, Sr, Y, Zr, Mo, Ru, Ag, Cd, Sn, Cs, La, Pr, Sm, Gd, Tb, Ta, Au, Tl, Co, In, and Bi are each 0.1 ppb or less and the concentrations of Ba, Nd, Pb, And Ce are each 1 ppb or less in a physiological saline solution for injection both three months and six months after said physiological saline solution for injection is sealed in the blood purification device; and the number of fine particles having a size of 10 ?m or more is 25 or less and the number of fine particles having a size of 25 ?m or more is 3 or less in 1 mL of the physiological saline solution for injection.

Abstract: Provided is a blood purification device including a porous molded body that has a high phosphorus adsorption capacity and that can be used safely. A blood purification device includes a porous molded body containing an inorganic ion-adsorbing material and is characterized by the following: said blood purification device satisfies the relationship B=?0.02 A+2.175±0.185 (74?A?94) when the moisture content of the porous molded body is denoted by A and the bulk density is denoted by B; and the number of fine particles having a size of 10 ?m or more is 25 or less and the number of fine particles having a size of 25 ?m or more is 3 or less in 1 mL of a physiological saline solution for injection both three months and six months after said physiological saline solution for injection is sealed in the blood purification device.

Abstract: An extracorporeal blood circulation device is provided with: a blood component adjuster; a blood purification device; a pipe system provided with a pump for supplying blood from a blood collecting part to the blood component adjuster, a valve for supplying a physiological saline solution, and a pressure gauge for sensing a pressure loss; a bypass pipe system for bypassing the blood component adjuster and supplying blood to the blood purification device; a pipe system for connecting the blood component adjuster and the blood purification device, the pipe system being provided with a pressure gauge for sensing a pressure loss; a pipe system provided with a valve for returning blood from the blood purification device to a reinfusion part and recovering the physiological saline solution, and a pressure gauge for sensing a pressure loss; and a control unit for switching to the bypass pipe system and switching to a reinfusion mode.

Abstract: Provided is a blood purification device including a porous molded body that has a high phosphorus adsorption capacity and that can be used safely. A blood purification device includes a porous molded body containing an inorganic ion-adsorbing material and is characterized by the following: said blood purification device satisfies the relationship B=?0.02 A+2.175±0.185 (74?A?94) when the moisture content of the porous molded body is denoted by A and the bulk density is denoted by B; and the number of fine particles having a size of 10 ?m or more is 25 or less and the number of fine particles having a size of 25 ?m or more is 3 or less in 1 mL of a physiological saline solution for injection both three months and six months after said physiological saline solution for injection is sealed in the blood purification device.

Abstract: A blood purification device includes a porous molded body containing an inorganic ion-adsorbing material and is characterized by the following: the concentrations of Mg, Al, Ti, V, Cr, Mn, Fe, Ni, Cu, Zn, Ga, Rb, Sr, Y, Zr, Mo, Ru, Ag, Cd, Sn, Cs, La, Pr, Sm, Gd, Tb, Ta, Au, Tl, Co, In, and Bi are each 0.1 ppb or less and the concentrations of Ba, Nd, Pb, And Ce are each 1 ppb or less in a physiological saline solution for injection both three months and six months after said physiological saline solution for injection is sealed in the blood purification device; and the number of fine particles having a size of 10 ?m or more is 25 or less and the number of fine particles having a size of 25 ?m or more is 3 or less in 1 mL of the physiological saline solution for injection.

Abstract: A hollow fiber membrane module includes: a tubular container accommodating a hollow fiber membrane bundle; headers, and potted parts. The header includes a header protrusion that protrudes in an annular shape toward the tubular container. The tubular container includes double annular protrusions, which are an inner protrusion and an outer protrusion protruding toward the header. The header and the tubular container are welded together by ultrasonic welding, with the header protrusion being inserted between the inner protrusion and the outer protrusion of the tubular container. The header protrusion and the inner protrusion of the tubular container are welded together at least in one or more regions, and the header protrusion and the outer protrusion of the tubular container are welded together at least in one or more regions.

Abstract: The hollow fiber membrane module according to the present application is provided with a cylindrical container open at one end and the other end, a bundle of hollow fiber membranes packed in the cylindrical container, potting parts embedding and fixing the bundle of hollow fiber membranes at both ends of the cylindrical container, and headers provided at both ends of the cylindrical container and having nozzles that constitute an inlet and outlet for a fluid. In this hollow fiber membrane module, the headers and the cylindrical container are welded in at least two areas including a primary weld and a secondary weld, and the secondary weld is located in a position where welding is initiated after or simultaneously with the beginning of welding of the primary weld.

Abstract: The present invention provides a separation membrane for blood processing, comprising a polysulfone polymer, a hydrophilic polymer and a polymer having a hydroxy group in a side chain and having a solubility of 0.5 g or less in water (100 g) at 20° C., in which the content of the polymer falls within a specific range, and a blood processing apparatus having the membrane installed therein.

Abstract: A hollow fiber membrane blood purifying device including a cylindrical container, a hollow fiber membrane bundle, a potting resin fixing portion embedding and fixing the hollow fiber membrane bundle at each end of the cylindrical container, headers having nozzles, and ports further has the structure in which each header and the cylindrical container are welded in at least two regions over the circumference. The inside face of the header is in contact with a potting resin fixing portion cut face that is formed by cutting an outer side portion of the potting resin fixing portion in the length direction of the cylindrical container than the end face of each end of the cylindrical container, and the potting resin fixing portion cut face is in a compressively deformed state.

Abstract: An object of the present invention is to provide a separation membrane for blood treatment excellent in blood compatibility and reduced in elution of nitric acid ion from an inner surface even if radiation sterilization is applied in a dry state and to provide a blood treatment device having the membrane incorporated therein. The present invention provides a separation membrane for blood treatment containing at least a polysulfone resin and polyvinylpyrrolidone, wherein a proportion of intermediate water present in water in a functional separation surface of the separation membrane is 40% or more at the time when the content of water reaches a saturation point by impregnating a dry-state separation membrane with water, a water content of the separation membrane is 10% or less, and the separation membrane is subjected to radiation sterilization.

Abstract: An object of the present invention is to provide a separation membrane for blood processing having high blood compatibility and storage stability and membrane performance that rarely deteriorates even if irradiation sterilization treatment is applied, and provide a blood processing apparatus having the membrane installed therein. The present invention is also directed to providing a separation membrane for blood processing having satisfactory air-bleeding during priming treatment of the blood processing membrane, and providing a blood processing apparatus having the membrane installed therein. The present invention provides a separation membrane for blood processing, comprising a polysulfone polymer, a hydrophilic polymer and a polymer having a hydroxy group in a side chain and having a solubility of 0.5 g or less in water (100 g) at 20° C., in which the content of the polymer falls within a specific range, and a blood processing apparatus having the membrane installed therein.

Abstract: To provide an efficient sterilization method for inexpensively sterilizing a medical article having a complex shape such as a body fluid treatment device of a generally-called dry or semi-dry type by so applying an electron beam that the overall absorbed dose distribution is small and to provide its application package form. [MEANS FOR SOLVING PROBLEMS] A method for sterilizing tubular body fluid treatment devices of a dry or semi-dry type contained in an electron beam-transmitting case with an electron beam. The method is characterized in that a stack structure which includes a gap layer having an average density of 0.010 to 0.180 g/cm3 and two body fluid treatment device layers having an average density of 0.050 to 0.200 g/cm3 and sandwiching the gap layer is contained in the electron beam-transmitting case, and the case is irradiated with the electron beam.

Abstract: It is intended to provide a highly reliable medical device, for example, hollow fiber membrane-type medical device, which can effectively prevent the occurrence of dielectric breakdown in an electron beam irradiation sterilization step. The present invention provides a hollow fiber membrane-type medical device comprising: a container having an inner space molded with an insulating material; a filter medium loaded in the inner space; an inlet provided on a container wall surface defining the inner space and intended for fluid influx into the container; an outlet provided on the container wall surface defining the inner space and intended for fluid efflux from the container, wherein the inlet and/or the outlet have a portion consisting of a polymer material having volume resistivity of 5×1013 ?·cm or smaller, and the medical device has been irradiated with an electron beam.

Abstract: [PROBLEMS] To provide an efficient sterilization method for inexpensively sterilizing a medical article having a complex shape such as a body fluid treatment device of a generally-called dry or semi-dry type by so applying an electron beam that the overall absorbed dose distribution is small and to provide its application package form. [MEANS FOR SOLVING PROBLEMS] A method for sterilizing tubular body fluid treatment devices of a dry or semi-dry type contained in an electron beam-transmitting case with an electron beam. The method is characterized in that a stack structure which includes a gap layer having an average density of 0.010 to 0.180 g/cm3 and two body fluid treatment device layers having an average density of 0.050 to 0.200 g/cm3 and sandwiching the gap layer is contained in the electron beam-transmitting case, and the case is irradiated with the electron beam.

Abstract: It is intended to provide asymmetric porous films which are usable in blood dialysis, plasma separation, etc. and particularly excellent in the performance of selectively separating (fractionating) plasma protein, show little endogenous coagulation, complement or quinine activily and have an extremely high biocompatibility. Porous films made mainly of a synthetic polymer and having an asymmetric structure wherein, in the sectional structure, a dense layer substantially not charged at least on the outermost surface is provided in the side on which a liquid to be treated is loaded and at least part of the film other than the outermost surface is negatively charged. In the above films, the dense layer non-charged at least on the outermost surface serves as a size barrier while the part of the film other than the outermost surface serves as a charge barrier.

Abstract: A hollow fiber membrane type blood purification device packed with hollow fiber membranes comprising a polysulfone resin and polyvinylpyrrolidone. Even when sterilized by irradiation with a radiation, the hollow fiber membrane type blood purification device is less apt to suffer polyvinylpyrrolidone elution and can be inhibited from decreasing in blood compatibility. The purification device is of the type called semi-dry, and is lightweight and has excellent handleability. The hollow fiber membrane type blood purification device comprises a bundle of hollow fiber membranes comprising a polysulfone resin and polyvinylpyrrolidone, a container packed therewith, and a potting agent disposed between each bundle end and the container to hold the bundle and thereby form a hollow-fiber-membrane inside chamber and a hollow-fiber-membrane outside chamber.

Abstract: It is intended to provide asymmetric porous films which are usable in blood dialysis, plasma separation, etc. and particularly excellent in the performance of selectively separating (fractionating) plasma protein, show little endogenous coagulation, complement or quinine activily and have an extremely high biocompatibility. Porous films made mainly of a synthetic polymer and having an asymmetric structure wherein, in the sectional structure, a dense layer substantially not charged at least on the outermost surface is provided in the side on which a liquid to be treated is loaded and at least part of the film other than the outermost surface is negatively charged. In the above films, the dense layer non-charged at least on the outermost surface serves as a size barrier while the part of the film other than the outermost surface serves as a charge barrier.

Abstract: A microporous membrane is produced by cooling a solution comprising a vinylidene fluoride homopolymer or copolymer having a weight average molecular weight of 1×105 or more and a solvent therefor, to form a two-phase gel, said microporous membrane comprising a polymer phase comprising said vinylidene fluoride homopolymer or copolymer, and intercommunicating voids which have an average pore size measured by the half-dry method of 0.005 to 5 &mgr;m and range from one side of the membrane to the other side, and said microporous membrane having as its internal structure a percolation structure in which the polymer phase forms an isotropic network structure by three-dimensional branching in arbitrary directions, the voids are formed by surrounding by said polymer phase of the network structure and intercommunicate with one another, and the ratio of the maximum pore size measured by the bubble point method to the average pore size measured by the half-dry method is 2.0 or less.