HIGH CUT-OFF HEMODIALYSIS MEMBRANE FOR USE IN LIVER DIALYSIS

• US 20120305486A1
• Filed: 04/13/2011
• Published: 12/06/2012
• Est. Priority Date: 04/20/2010
• Status: Active Grant

• Current Assignee: Gambro Lundia AB (Baxter International Inc.)
• Original Assignee: Gambro Lundia AB (Baxter International Inc.)
• Inventors: Storr, Markus, Krause, Bernd, Goehl, Hermann, Ertl, Thomas, Gekeler, Alexander
• Granted Patent: US 11,478,757 B2
• Time in Patent Office: Days
• US Class Current: 210/646
• CPC Class Codes: A61M 1/16 with membranes
• CPC Class Codes: A61M 1/1696 with dialysate regeneration
• CPC Class Codes: A61M 2210/1071 Liver; Hepar
• CPC Class Codes: B01D 2325/20 Specific permeability or cut-off range
• CPC Class Codes: B01D 61/243 Dialysis
• CPC Class Codes: B01D 67/0009 by phase separation, sol-gel transition, evaporation or solvent quenching
• CPC Class Codes: B01D 69/08 Hollow fibre membranes manufacture of hollow fibres D01D5/24, D01F1/08
• CPC Class Codes: B01D 69/087 Details relating to the spinning process
• CPC Class Codes: B01D 71/68 Polysulfones; Polyethersulfones

Abstract

A system for liver dialysis makes use of a high cut-off hemodialysis membrane for removing water-soluble and protein-bound toxins from the blood of a person in need. A high cut-off hollow fiber hemodialysis membrane has improved potential to remove albumin-bound toxins and inflammatory mediators.

Claims

1. A liver dialysis device for conducting hemodialysis on a patient suffering from liver failure, comprising a dialysis membrane that allows the passage of molecules having a molecular weight of up to 45 kDa with a sieving coefficient of 0.1 to 1.0 in the presence of whole blood.

2. A liver dialysis device according to claim 1, wherein the dialysis reduces the concentration of protein-bound toxins and inflammatory cytokines in the blood of the patient.

3. A liver dialysis device according to claim 2, wherein the dialysis reduces the concentration of unconjugated bilirubin and bile acids in the blood of the patient.

4. A liver dialysis device according to claim 1 wherein the dialysate passing the said dialysis membrane comprises from 1% to 25% human serum albumin.

5. A liver dialysis device according to claim 1 wherein at least one hydrophilic polymer and at least one hydrophobic polymer are present as domains on the surface of the dialysis membrane.

6. A liver dialysis device according to claim 1 wherein the dialysis membrane is a hollow fiber membrane and has at least a 3-layer asymmetric structure with a separation layer present in the innermost layer of the hollow fiber membrane.

7. A liver dialysis device according to claim 1 wherein the dialysis membrane has pores in the separation layer, said pores having a diameter in the range of 15 to 60 nm, preferably 20 to 40 nm.

8. A liver dialysis device according to claim 1 wherein the dialysis membrane has a sieving coefficient in plasma for albumin of from 0.1 to 0.2.

12. A liver dialysis device according to claim 2, wherein the dialysate passing the said dialysis membrane comprises from 1% to 25% human serum albumin.

13. A liver dialysis device according to claim 3, wherein the dialysate passing the said dialysis membrane comprises from 1% to 25% human serum albumin.

14. A liver dialysis device according to claim 2 wherein at least one hydrophilic polymer and at least one hydrophobic polymer are present as domains on the surface of the dialysis membrane.

15. A liver dialysis device according to claim 3 wherein at least one hydrophilic polymer and at least one hydrophobic polymer are present as domains on the surface of the dialysis membrane.

16. A liver dialysis device according to claim 4 wherein at least one hydrophilic polymer and at least one hydrophobic polymer are present as domains on the surface of the dialysis membrane.

17. A liver dialysis device according to claim 2 wherein the dialysis membrane is a hollow fiber membrane and has at least a 3-layer asymmetric structure with a separation layer present in the innermost layer of the hollow fiber membrane.

18. A liver dialysis device according to claim 3 wherein the dialysis membrane is a hollow fiber membrane and has at least a 3-layer asymmetric structure with a separation layer present in the innermost layer of the hollow fiber membrane.

19. A liver dialysis device according to claim 4 wherein the dialysis membrane is a hollow fiber membrane and has at least a 3-layer asymmetric structure with a separation layer present in the innermost layer of the hollow fiber membrane.

20. A liver dialysis device according to claim 5 wherein the dialysis membrane is a hollow fiber membrane and has at least a 3-layer asymmetric structure with a separation layer present in the innermost layer of the hollow fiber membrane.

9. A method for the treatment of liver failure, the method comprising conducting hemodialysis on a patient suffering from liver failure using a liver dialysis device comprising a dialysis membrane that allows the passage of molecules having a molecular weight of up to 45 kDa with a sieving coefficient of 0.1 to 1.0 in the presence of whole blood.

10. A method for reducing the concentration of protein-bound toxins and inflammatory cytokines in the blood of a patient, the method comprising conducting hemodialysis on the patient using a liver dialysis device comprising a dialysis membrane that allows the passage of molecules having a molecular weight of up to 45 kDa with a sieving coefficient of 0.1 to 1.0 in the presence of whole blood.

11. A method for the treatment of any of hepatorenal syndrome, decompensated chronic liver disease, acute liver failure, graft dysfunction after liver transplantation, liver failure after liver surgery, secondary liver failure, multi organ failure and intractable pruritus in cholestasis, the method comprising conducting hemodialysis on a sufferer using a liver dialysis device comprising a dialysis membrane that allows the passage of molecules having a molecular weight of up to 45 kDa with a sieving coefficient of 0.1 to 1.0 in the presence of whole blood.