Method and composition for removing uremic toxins in dialysis processes

• US 8,066,658 B2
• Filed: 05/13/2009
• Issued: 11/29/2011
• Est. Priority Date: 11/13/2001
• Status: Expired due to Term

• Current Assignee: Baxter International Inc.
• Original Assignee: Baxter International Inc.
• Inventors: Martis, Leo, Donovan, Brian, Karoor, Sujatha, Sanders, Paul J., Mujais, Salim, Lu, Luis, Morti, Stavroula, Hai, Ton That, Soltys, Paul J., Tandon, Rahul, Katada, Mari
• Primary Examiner(s): BOUCHELLE, LAURA A
• Application Number:
  US12/465,214
• Publication Number:
  US 20090218288A1
• Time in Patent Office: 930 Days
• Field of Search: 604/29, 604/5.01, 604/5.04, 604/43
• US Class Current: 604/5.01
• CPC Class Codes: A61M 1/155 with treatment-fluid pumping means or components thereof
• CPC Class Codes: A61M 1/1696 with dialysate regeneration
• CPC Class Codes: A61M 1/284 Continuous flow peritoneal dialysis [CFPD]
• CPC Class Codes: A61M 1/287 Dialysates therefor
• CPC Class Codes: B01D 15/00 Separating processes involving the treatment of liquids with solid sorbents using liquid sorbents B01D11/00; ion exchange processes or materials, sorbent materials in general B01J, e.g. sorbents for chromatography B01J20/281; for investigating or analysing materials G01N30/00; Apparatus therefor
• CPC Class Codes: B01J 20/0211 Compounds of Ti, Zr, Hf
• CPC Class Codes: B01J 20/0292 Phosphates of compounds other than those provided for in B01J20/048
• CPC Class Codes: B01J 20/06 comprising oxides or hydroxides of metals not provided for in group B01J20/04
• CPC Class Codes: B01J 20/20 comprising free carbon; comprising carbon obtained by carbonising processes
• CPC Class Codes: B01J 20/22 comprising organic material
• CPC Class Codes: B01J 20/28052 Several layers of identical or different sorbents stacked in a housing, e.g. in a column
• CPC Class Codes: B01J 39/10 Oxides or hydroxides
• CPC Class Codes: B01J 39/12 Compounds containing phosphorus
• CPC Class Codes: B01J 41/10 Inorganic material

Abstract

Methods and devices for providing dialysis treatment are provided. The device includes a resin bed including zirconium phosphate, zirconium oxide, and urease.

Claims

1. A cartridge for use in a dialysis system for removing toxins comprising:

a body having an inlet end and an outlet end;

an interior including at least four layers, the layers including a first layer of a resin selected from the group consisting of zirconium phosphate having a pH of approximately 2.5 to about 5 and urease, a second layer of a resin selected from the group consisting of zirconium oxide having a pH of approximately 9 to about 13 and urease, a third layer of zirconium phosphate, and a fourth layer of zirconium oxide having a pH of approximately 6.5 to about 7.5;

wherein the first layer is different from the second layer; and

the interior being so constructed and arranged that a fluid entering the interior from the inlet end flows through the first layer, then the second layer, then the third layer, and then the fourth layer.

2. The cartridge of claim 1 wherein the zirconium oxide has been modified to remove a nitrate ion and substitute a bicarbonate ion therefor.

3. The cartridge of claim 1 wherein the zirconium oxide is in hydroxyl form.

4. The cartridge of claim 1 including a carbon layer located in juxtaposition to the outlet.

5. The cartridge of claim 1 wherein the first layer comprises approximately 200 to about 800 grams of zirconium phosphate.

6. A method for providing dialysis, the method comprising passing a dialysis fluid through a body having an inlet and an outlet and defining an interior, the interior including at least four layers, a first layer comprising either zirconium phosphate having a pH of approximately 2.5 to about 5 or urease, a second layer comprising either zirconium oxide having a pH of approximately 9 to about 13 or urease, a third layer comprising zirconium phosphate and a fourth layer comprising zirconium oxide having a pH of approximately 6.8 to about 7.5;

wherein the first layer is different from the second layer.

7. The method of claim 6 wherein the dialysis fluid passing through the body contacts the fourth layer before contacting the first layer, the second layer and the third layer.

8. The method of claim 6 wherein the body includes two separate layers of zirconium oxide.

9. The method of claim 6 wherein the zirconium oxide is in bicarbonate form.

10. The method of claim 6 wherein the zirconium oxide is in hydroxyl form.

11. The method of claim 6 wherein the body includes a carbon layer positioned in juxtaposition to the outlet.

12. The method of claim 6 wherein the first layer comprises approximately 200 to about 800 grams of zirconium phosphate.

13. The method of claim 6 wherein the fourth layer comprises approximately 50 to about 200 grams of carbon.

14. A method of providing regenerative dialysis, the method comprising the step-ef removing at least some uremic toxins by passing a dialysis fluid through a body having an inlet and an outlet and defining an interior, the interior including at least four layers, a first layer comprising either zirconium phosphate having a pH of approximately 2.5 to about 5 or urease, a second layer comprising either zirconium oxide having a pH of approximately 9 to about 13 or urease, a third layer comprising zirconium phosphate and a fourth layer comprising zirconium oxide having a pH of approximately 6.8 to about 7.5;

wherein the first layer is different from the second layer.

15. The method of claim 14 wherein the pH of the dialysis fluid as it exits the body is approximately 7.4.

16. The method of claim 14 wherein the pH of the dialysis fluid prior to entering the body is acidic.

17. The method of claim 14 wherein the pH of the dialysis fluid prior to entering the body is basic.

18. A device for regenerating a dialysis solution comprising:

a body including a resin bed, the resin bed including at least a layer of urease, zirconium phosphate, zirconium oxide, and carbon and being so constructed and arranged that a dialysis solution having a pH that is either basic or acidic entering the resin bed will exit the resin bed at a pH of approximately 7 to about 7.8, wherein a fourth layer of the resin bed contacted by the dialysis solution is zirconium oxide having a pH of approximately 6.8 to about 7.5.

19. A device for treating a patient with a dialysis solution comprising:

a body defining an interior and including an inlet, an outlet, and a resin bed comprising a layer of urease, a layer of zirconium oxide, and a layer of zirconium phosphate, wherein the inlet is in fluid communication with a source of basic or acidic dialysis solution and the resin bed is oriented so that a first layer of the resin bed that the dialysis solution contacts is either the urease layer or the zirconium phosphate layer and the zirconium oxide layer is so constructed and arranged that the dialysis solution entering the inlet will pass through the resin bed and exit the outlet with a physiologically acceptable pH, wherein the zirconium phosphate has a pH of approximately 2.0 to about 5.

20. A device for treating a patient with a dialysis solution comprising:

a body defining an interior and including an inlet, an outlet, and a resin bed comprising a layer of urease, a layer of zirconium oxide, and a layer of zirconium phosphate, wherein the inlet is in fluid communication with a source of basic or acidic dialysis solution and the resin bed is oriented so that a first layer of the resin bed that the dialysis solution contacts is either the urease layer or the zirconium phosphate layer and the zirconium oxide layer is so constructed and arranged that the dialysis solution entering the inlet will pass through the resin bed and exit the outlet with a physiologically acceptable pH, wherein the zirconium oxide layer has a pH of approximately 6.8 to about 7.5.

21. A method for constructing a cartridge for use in a system for providing dialysis, the method comprising:

providing a resin bed including a zirconium oxide layer and a zirconium phosphate layer; and

selecting and orienting the layers of zirconium oxide and zirconium phosphate to allow the resin bed to remove uremic toxins present in a dialysis solution entering the resin bed and causing the dialysis solution exiting the cartridge to have a physiological pH and a physiological acceptable electrolyte balance, wherein the zirconium phosphate layer has a pH of approximately 2 to about 8.

22. A method for constructing a cartridge for use in a system for providing dialysis, the method comprising:

providing a resin bed including a zirconium oxide layer and a zirconium phosphate layer; and

selecting and orienting the layers of zirconium oxide and zirconium phosphate to allow the resin bed to remove uremic toxins present in a dialysis solution entering the resin bed and causing the dialysis solution exiting the cartridge to have a physiological pH and a physiological acceptable electrolyte balance, wherein the zirconium oxide layer has a pH of approximately 6 to about 13.