Blood purifier and blood purifier package

Patent metadata

Field	Value
Publication number	US-9987409-B2
Application number	US-201514722756-A
Country	US
Kind code	B2
Filing date	May 27, 2015
Priority date	Oct 15, 2004
Publication date	Jun 5, 2018
Grant date	Jun 5, 2018

Abstract

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.

First claim

The invention claimed is:

1. A blood purifier comprising selectively permeable separation membranes as a main component, characterized in that the amount of hydrogen peroxide which is extracted from the selectively permeable separation membranes 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,
wherein the selectively permeable separation membranes comprise a polysulfone-based polymer containing polyvinyl pyrrolidone, and
wherein the blood purifier is sealed together with an oxygen scavenger capable of releasing moisture in a packaging material capable of shutting out external air and water vapor,
the atmosphere inside the packaging material has a relative humidity of higher than 68% RH at room temperature, and
the blood purifier has been sterilized by exposure of the blood purifier within the sealed packaging material to a radioactive ray, an electron ray, or both a radioactive ray and an electron ray.

2. The blood purifier according to claim 1 , wherein the selectively permeable separation membranes have a moisture content of not higher than 2.5 mass %.

3. A blood purifier package comprising the blood purifier of claim 1 packed in a packaging material.

4. The blood purifier package according to claim 3 , wherein the oxygen permeability of the packaging material is not higher than 1 cm 3 /(m 2 ·24 hr·atm) (20° C. and 90% RH).

5. The blood purifier package according to claim 3 , wherein the water vapor permeability of the packaging material is not higher than 5 g/(m 2 ·24 hr·atm) (40° C. and 90% RH).

6. The blood purifier package according to claim 4 , wherein the water vapor permeability of the packaging material is not higher than 5 g/(m 2 ·24 hr·atm) (40° C. and 90% RH).

7. The blood purifier package according to claim 3 , wherein the selectively permeable separation membranes have a moisture content of not higher than 2.5 mass %.

Assignees

• Nipro Corp

Inventors

• Mabuchi Kimihiro
• Monden Noriko
• Kato Noriaki
• Hatakeyama Yuuki
• Sunohara Takashi
• Masuda Toshiaki

Classifications

• A61L2103/09

  Blood or products thereof · CPC title

• B01D2325/38

  Hydrophobic membranes · CPC title

• B01D2323/34

  Use of radiation · CPC title

• A61L2/087

  Particle radiation, e.g. electron-beam, alpha or beta radiation · CPC title

• B01D65/022

  Membrane sterilisation · CPC title