Claims for Patent: 4,402,940

Summary for Patent: 4,402,940

Title:	Method for treating blood plasma employing a hollow fiber membrane
Abstract:	This invention provides a method for treating blood plasma wherein a hollow fiber membrane which comprises at least a skin layer on one surface of the membrane and also a porous layer inside the membrane is employed. The skin layer of the membrane has micropores with average pore size of 50 to 450 A, and the membrane shows a water permeability of 80 ml/m.sup.2.hr.mmHg or more, and permeabilites for human blood plasma albumin of 85% or more and for human blood plasma immunoglobulin G(IgG) of 80% or more, and a rate of inhibition against human blood plasma immunoglobulin M(IgM) of 40% or more. Use of the above mentioned hollow fiber membrane, which makes it possible to selectively remove immune complex, rheumatoid factors, etc., without decrease in levels of immunological functions, brings excellent effects on therapy of autoimmune diseases.
Inventor(s):	Nose; Yukihiko (Cleveland, OH), Kayashima; Koji (Mayfield, OH), Sueoka; Akinori (South Euclid, OH), Asanuma; Yoshihiro (Sendai, JP), Shinagawa; Shigeru (Cleveland, OH), Smith; James (Cleveland, OH), Werynski; Andrej (Warsaw, PL), Malchesky; Paul S. (Painesvilla Township, Lake County, OH)
Assignee:	Kuraray Co., Ltd. (Kurashiki, JP)
Application Number:	06/418,551
Patent Claims:	1. A method for treating the blood plasma to selectively reduce the amount of a disease factor therein comprising fractionating the plasma with a hollow fiber membrane comprising a skin layer on at least one surface of said membrane and a porous layer inside said membrane with average pore size of micropores of said skin layer in the range of 50 to 450 A, that of micropores of the porous layer ranging from 500 to 15,000 A, void volume of said membrane at a level of 50 to 85% and water permeability at a level of 80 ml/m.sup.2.hr.mmHg or higher, such that the amount of the disease factor in one of the fractions produced is decreased. 2. A method for treating the blood plasma as claimed in claim 1, wherein said hollow fiber membrane has a skin layer on its exterior surface and a porous supporting layer both inside and on the interior surface of said membrane. 3. A method for treating the blood plasma as claimed in claim 1 or claim 2, wherein said hollow fiber membrane shows permeabilities for human blood plasma albumin and human blood plasma immunoglobulin G of 85% or more and 80% or more, respectively, and a rate of inhibition against human blood plasma immunoglobulin M of 40% or more. 4. A method for treating the blood plasma as claimed in any one of claims 1 to 3, wherein the skin layer of said hollow fiber membrane is 100 to 30,000 A thick. 5. A method for treating the blood plasma as claimed in any one of claims 1 to 4, wherein thickness of the hollow fiber membrane ranges 10 to 90.mu. and inside diameter thereof is in the range of 50 to 800.mu.. 6. A method for treating the blood plasma as claimed in any one of claims 1 to 5, wherein water permeability is in the range of 80 to 1,500 ml/m.sup.2.hr.mmHg. 7. A method for treating the blood plasma as claimed in any one of claims 1 to 6, wherein the hollow fiber membrane is composed of a vinyl alcohol polymer. 8. A method for treating the blood plasma as claimed in claim 7, wherein said vinyl alcohol polymer is an ethylene-vinyl alcohol copolymer.

Details for Patent 4,402,940

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Grifols Therapeutics Llc	ALBUKED, PLASBUMIN-20, PLASBUMIN-25, PLASBUMIN-5	albumin (human)	For Injection	101138	10/21/1942		2002-03-12
Baxalta Us Inc.	BUMINATE, FLEXBUMIN	albumin (human)	Injection	101452	03/03/1954		2002-03-12
Csl Behring Ag	ALBURX	albumin (human)	Injection	102366	07/23/1976		2002-03-12
Grifols Biologicals Llc	ALBUTEIN	albumin (human)	Injection	102478	08/15/1978		2002-03-12
Instituto Grifols, S.a.	HUMAN ALBUMIN GRIFOLS	albumin (human)	Injection	103352	02/17/1995		2002-03-12