Medical apparatus for the extracorporeal treatment of blood or plasma, and processes for using this apparatus

• US 6,248,238 B1
• Filed: 04/21/1997
• Issued: 06/19/2001
• Est. Priority Date: 04/19/1996
• Status: Expired due to Term

• Current Assignee: Industries Gambro
• Original Assignee: Hospal Industrie
• Inventors: Valette, Pierre, Thomas, Michel, Burtin, Jacques
• Primary Examiner(s): KIM, SUN U
• Application Number:
  US08/845,142
• Time in Patent Office: 1,520 Days
• Field of Search: 210/500.21, 210/500.24, 210/500.43, 210/645
• US Class Current: 210/646
• CPC Class Codes: A61M 1/16 with membranes
• CPC Class Codes: B01D 63/021 Manufacturing thereof
• CPC Class Codes: B01D 65/022 Membrane sterilisation
• CPC Class Codes: B01D 67/0088 Physical treatment with compounds, e.g. swelling, coating or impregnation
• CPC Class Codes: B01D 67/0093 Chemical modification

Abstract

A medical apparatus for the extracorporeal treatment of blood or plasma comprises a semi-permeable membrane consisting of at least one electronegative polymer, such that the surface of the semi-permeable membrane has negative electric charges. Before the sterilization of the apparatus, and before or after the formation of the membrane, at least one cationic and anti-protease agent is incorporated in at least one part of the membrane, this agent undergoing bulk adsorption or semi-bulk adsorption in the membrane and/or being bound by an ionic interaction with the electronegative sites of the membrane.

Claims

1. Medical apparatus for the extracorporeal treatment of blood or plasma, comprising a semi-permeable membrane comprising at least one electronegative polymer, such that the surface of the semi-permeable membrane has negative electric charges, wherein the semi-permeable membrane has a negative electric charge density greater than 100 μ

eq per ml of swollen polymer wherein, before sterilization of the apparatus, at least one cationic and anti-protease agent is incorporated in at least one part of the membrane, wherein the anti-protease agent is present in sufficient quantities to prevent activation of the kallikrein-kinin system during treatment of blood or plasma, said agent being bound in the membrane by bulk adsorption or semi-bulk adsorption and/or being bound by an ionic interaction with the electronegative sites of the membrane.

2. Medical apparatus according to claim 1, wherein the cationic and anti-protease agent is nafamostat mesylate.

3. Medical apparatus according to claim 1, wherein the electronegative polymer is polyacrylonitrile.

4. Medical apparatus according to claim 1, wherein the electronegative polymer is a copolymer of acrylonitrile and at least one other monomer with olefinic unsaturation capable of being copolymerized with the acrylonitrile.

5. Medical apparatus according to claim 1, wherein the electronegative polymer is a copolymer of acrylonitrile, at least one anionic or anionizable monomer, and at least one non-ionic and non-ionizable monomer.

6. Medical apparatus according to claim 4, wherein the monomer with olefinic unsaturation, capable of being copolymerized with the acrylonitrile, carries anionic groups that are sulphonate, carboxyl, phosphate, phosphonate or sulphate groups.

7. Medical apparatus according to claim 6, wherein the anionic groups comprise sodium methallylsulphonate.

8. Medical apparatus according to claim 2, wherein the electronegative polymer is polyacrylonitrile.

9. An apparatus according to claim 1, wherein the apparatus is in an unsterilized form.

10. An apparatus according to claim 1, wherein the apparatus is in a sterilized form.

13. A method of conducting hemodialysis according to claim 1, wherein the electronegative polymer is polyacrylonitrile, and the at least one cationic and anti-protease agent is nafamostat mesylate.

11. In a method of conducting hemodialysis in a medical apparatus, the improvement comprising conducting hemodialysis with a medical apparatus so as to prevent activation of the kallikrein-kinin system said medical apparatus being in sterilized form and comprising a semi-permeable membrane comprising at least one electronegative polymer, such that the surface of the semi-permeable membrane has negative electric charges, this apparatus being characterized in that, before sterilization of the apparatus, at least one cationic and anti-protease agent is incorporated in at least one part of the membrane, wherein the anti-protease agent is present in sufficient quantities to prevent activation of the kallikrein-kinin system during treatment of blood or plasma, said agent being bound in the membrane by bulk adsorption or semi-bulk adsorption and/or being bound by an ionic interaction with the electronegative sites of the membrane.

12. A method according to claim 11, wherein the semi-permeable membrane has a negative electric charge density greater than 100 μ

eq per ml of swollen polymer.

14. A method according to claim 11, wherein the electronegative polymer is polyacrylonitrile.

15. A method according to claim 11, wherein the electronegative polymer is a copolymer of acrylonitrile and at least one other monomer with olefinic unsaturation capable of being copolymerized with the acrylonitrile.

16. A method according to claim 11, wherein the electronegative polymer is a copolymer of acrylonitrile, at least one anionic or anionizable monomer, and at least one non-ionic and non-ionizable monomer.

17. A method according to claim 15, wherein the monomer with olefinic unsaturation, capable of being copolymerized with the acrylonitrile, carries anionic groups that are sulphonate, carboxyl, phosphate, phosphonate or sulphate groups.