Nipro Corporation

Daicen Membrane-Systems, Ltd.

Takashi Sunohara

Toshiaki Masuda

Noriaki Kato

Noriko Monden

Kimihiro Mabuchi

Yuuki Hatakeyama

Hideyuki Yokota

Akinobu Yamaguchi

Yasuhiko Morita

Toshinari Takahashi

Yuki Hatakeyama

Hidehiko Anbo

Masuda Toshiaki

Shuji Nakatsuka

A hollow fiber porous membrane includes polyethersulfone or polysulfone. The hollow fiber porous membrane has an inner diameter from 300-600 μm, a thickness from 70-200 μm, a molecular weight cut-off of 10000 or lower, and a plurality of pores having a pore diameter from 0.1-0.5 μm throughout an outer surface; and a bulging rate of less than 5%. For 20 or more of the hollow fiber porous membranes, after a membrane thickness in a cross section of each one of the hollow fiber porous membranes in the width direction is measured at randomly selected 10 or more locations, an average membrane thickness is calculated based on 200 or more locations in total, and the bulging rate is calculated by a formula below: Bulging Rate (%)=(location numbers where the membrane thickness as measured exceeded 1.3 times the average membrane thickness)/(membrane thickness measurement numbers)×100.

Porous hollow fiber membrane

The invention provides a method for sterilizing a blood purifier, as well as a blood purifier package. The method is effective to decrease the amounts of extracts from the blood purifier attributed to the deterioration of the selectively permeable separation membranes with time during and after exposure to a radioactive ray or an electron ray, and is highly reliable in safety when employed for hemocatharsis therapy. The method for sterilizing a blood purifier which comprises substantially dried selectively permeable separation membranes as a main component, by way of the exposure of the same blood purifier to a radioactive ray and/or an electron ray, is characterized in that the blood purifier is sealed in a packaging bag, together with an oxygen scavenger and a humectant or together with an oxygen scavenger capable of releasing a moisture, and is then sterilized in such a sealed state by the above exposure.

Method for sterilizing blood purifier and blood purifier package

The invention provides a blood purifier which shows a decreased amount of hydrogen peroxide extracted from its selectively permeable separation membranes, and thus is highly reliable in its safety in use for hemecatharysis. The blood purifier comprises selectively permeable separation membranes as a main component and is characterized in that the amount of hydrogen peroxide which is extracted from the selectively permeable separation membrane removed from the blood purifier after 3 months or longer has passed since the sterilization of the blood purifier by exposure to a radioactive ray and/or an electron ray is not larger than 10 ppm.

Blood purifier and blood purifier package

Objects of the invention are to provide a blood purifier package which shows a less increase in the amounts of extracts from the materials of its blood purifier, particularly of its selective permeable separation membranes, attributed to the deterioration of the same materials with time after exposure to a radioactive ray or an electron ray, and which is therefore highly reliable in safety in use for hemocatharsis, and to provide a process for manufacturing the same. The present invention relates to a blood purifier package obtained by packing a blood purifier which comprises selectively permeable separation membranes as a main component, and this blood purifier package is characterized in that the blood purifier is packed and sealed together with an oxygen scavenger in a packaging material capable of shutting out an external air and a water vapor, under a condition of a relative humidity of above 40% RH at 25&#xb0; C.

Blood purifier package and process for manufacturing the same

Objects of the present invention are to provide a blood purifier package which shows a less increase in the amounts of extracts from the materials of its blood purifier, particularly of its selective permeable separation membranes, attributed to the deterioration of the same materials with time after exposure to a radioactive ray or an electron ray, and which is therefore highly reliable in safety in use for hemocatharsis, and to provide a process for manufacturing the same. The present invention relates to a blood purifier package obtained by packing a blood purifier which comprises selectively permeable separation membranes as a main component, and this blood purifier package is characterized in that the blood purifier is packed and sealed together with an oxygen scavenger in a packaging material capable of shutting out an external air and a water vapor, under a condition of a relative humidity of above 40% RH at 25&#xb0; C.

The present invention provides a method for sterilizing a blood purifier, which method is effective to decrease the amounts of extracts from the blood purifier attributed to the deterioration of the selectively permeable separation membranes with time during and after exposure to a radioactive ray or an electron ray, and which method is highly reliable in safety when employed for hemocatharsis therapy. The present invention also provides a blood purifier package. The present invention relates to a method for sterilizing a blood purifier which comprises substantially dried selectively permeable separation membranes as a main component, by way of the exposure of the same blood purifier to a radioactive ray and/or an electron ray, and this method is characterized in that the blood purifier is sealed in a packaging bag, together with an oxygen scavenger and a humectant or together with an oxygen scavenger capable of releasing a moisture, and is then sterilized in such a sealed state by the above exposure.

The present invention provides a blood purifier which shows a decreased amount of hydrogen peroxide extracted from its selectively permeable separation membranes, and thus is highly reliable in its safety in use for hemecatharysis. The present invention relates to a blood purifier which comprises selectively permeable separation membranes as a main component and which is characterized in that the amount of hydrogen peroxide which is extracted from the selectively permeable separation membrane removed from the blood purifier after 3 months or longer has passed since the sterilization of the blood purifier by exposure to a radioactive ray and/or an electron ray is not larger than 10 ppm.

A packaged blood purification device including a hollow fiber blood-processing device having a bundle of hollow fibers and a cylindrical container holding the bundle of hollow fibers; and a gas-impermeable container for packaging the hollow fiber blood-processing device. The hollow fiber blood-processing device is sealed together with an oxygen absorber in the gas-impermeable container, and is sterilized with radiation. The blood-processing device is produced by a method including the steps of sealing a hollow fiber blood-processing device in said gas-impermeable container together with an oxygen absorber, and radiation sterilizing the blood-processing device held in the sealed gas-impermeable container.

Packaged blood purification device

The invention relates to a hollow fiber membrane module comprising polysulfone type selectively permeable hollow fiber membranes which contain a polysulfone-based resin and a hydrophilic polymer as main components, wherein (A) the content of the hydrophilic polymer in the uppermost layer of the inner surface of the hollow fiber membrane is at least 1.1 times larger than the content of the hydrophilic polymer in the proximate layer of the inner surface of the membrane, and (B) the content of the hydrophilic polymer in the uppermost layer of the outer surface of the hollow fiber membrane is at least 1.1 times larger than the content of the hydrophilic polymer in the uppermost layer of the inner surface of the membrane. The hollow fiber membrane module is exposed to a radioactive ray, on condition that the oxygen concentration of an ambient atmosphere around the hollow fiber membrane is from 0.001 to 0.1%, and that the moisture content of the hollow fiber membrane to the weight thereof is from 0.2 to 7 mass %.

Polysulfone type selectively permeable hollow fiber membrane module and process for manufacturing the same

A dialyzer including a substantially cylindrical case, a hollow fiber bundlemade of a plurality of hollow fiber membranes provided in the case, a blood flow path formed by lumens of the hollow fiber membranes, a dialysate flow path formed by a gap between the inner wall of the caseand the hollow fiber membranes, and a cylindrical elastic tubeinserted in the gap between the inner wall of the caseand the hollow fiber bundle

Dialyzer and method for manufacturing the same

A dialyzer in which a nearly cylindrical case is provided therein with a hollow fiber bundle made of a plurality of hollow fiber membranes, a blood flow path formed by lumens of the hollow fiber membranes, a dialyzate flow path formed by a space between the inner wall of the case and the hollow fiber membranes and a cylindrical heat-shrinkable tube provided on the outside of the hollow fiber bundle and at least a part of which can be shrunk by heating, and a method for manufacturing the dialyzer.

A connecting coupler which reduces the risk that an endotoxin or the like enters a dialysis solution and that the connecting coupler itself is deformed including a body made of an elastic material in which a tip portion of a connection plug of a dialyzer can be removably fitted into a plug-receiving opening portion of a solution transferring passage inside the body; a line connector which is fitted into the body and communicates with the solution transferring passage; a coupling tube which has a fixing portion fixedly fitted on the tip portion of the body and a coupling portion projecting from the fixing portion toward a front in an axial direction and removably fitable onto the connection plug; and a fixing mechanism which releasably fixes the coupling tube to the connection plug.

Growing community of inventors

Osaka, Japan

Takashi Sunohara