Cartridges useful in cleaning dialysis solutions

• US 7,033,498 B2
• Filed: 11/28/2001
• Issued: 04/25/2006
• Est. Priority Date: 11/28/2000
• Status: Expired due to Term

• Current Assignee: Renal Solutions, Inc. (Fresenius Medical Care AG)
• Original Assignee: Renal Solutions, Inc. (Fresenius Medical Care AG)
• Inventors: Wong, Raymond J.
• Primary Examiner(s): Walker, W. L.
• Assistant Examiner(s): MENON, KRISHNAN S
• Application Number:
  US09/996,505
• Publication Number:
  US 20020112609A1
• Time in Patent Office: 1,609 Days
• Field of Search: 210/321.71, 210/635, 210/656, 210/660, 210/661, 210/195.2, 210/198.2, 210/638, 210/502.1, 210/503, 210/509, 210/648, 210/663, 210/264, 210/284, 210/804, 428/402, 423/323, 423/419.1, 423/304, 423308-311
• US Class Current: 210/321.71
• CPC Class Codes: A61M 1/1696 with dialysate regeneration
• CPC Class Codes: A61P 7/08 Plasma substitutes; Perfusion solutions; Dialytics or haemodialytics; Drugs for electrolytic or acid-base disorders, e.g. hypovolemic shock artificial tears A61P27/04
• CPC Class Codes: B01J 20/0211 Compounds of Ti, Zr, Hf
• CPC Class Codes: B01J 20/0277 Carbonates of compounds other than those provided for in B01J20/043
• CPC Class Codes: B01J 20/0292 Phosphates of compounds other than those provided for in B01J20/048
• CPC Class Codes: B01J 20/043 Carbonates or bicarbonates, e.g. limestone, dolomite, aragonite
• CPC Class Codes: B01J 20/08 comprising aluminium oxide or hydroxide; comprising bauxite
• CPC Class Codes: B01J 20/20 comprising free carbon; comprising carbon obtained by carbonising processes
• 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 20/3234 Inorganic material layers
• CPC Class Codes: B01J 2220/42 Materials comprising a mixture of inorganic materials materials coated or impregnated on a carrier B01J20/32
• CPC Class Codes: B01J 2220/62 In a cartridge
• CPC Class Codes: C01G 25/00 Compounds of zirconium
• CPC Class Codes: C01G 25/006 Compounds containing, besides zirconium, two or more other elements, with the exception of oxygen or hydrogen
• CPC Class Codes: C01P 2004/61 Micrometer sized, i.e. from 1-100 micrometer
• CPC Class Codes: C01P 2006/82 water content
• CPC Class Codes: Y10T 428/2982 Particulate matter [e.g., sphere, flake, etc.]

Abstract

Cartridges useful in regenerating or purifying dialysis solutions are described as well as methods to regenerate or purify spent dialysis solutions. Dialysis systems using the sorbent cartridges of the present invention are further described.

Claims

1. A sorbent cartridge comprising at least two layers, wherein one of said layers comprises at least sodium zirconium carbonate in said sorbent cartridge.

2. The sorbent cartridge of claim 1, wherein wherein one of said layers consists essentially of sodium zirconium carbonate.

3. The sorbent cartridge of claim 1, further comprising zirconium phosphate.

4. The sorbent cartridge of claim 3, wherein said zirconium phosphate is present as a layer in said sorbent cartridge.

5. The sorbent cartridge of claim 3, wherein said zirconium phosphate comprises a H+ content of from about 1.4 to about 2.0 wt %;

a Na+ content of from about 4 to about 6 wt%;

a ZrO₂ wt % of from about 34 wt % to about 37 wt %;

a PO₄ wt % of from about 41 wt % to about 43 wt %; and

a H₂O wt % of from about 14 wt % to about 18 wt %, based on the weight of the zirconium phosphate.

6. The sorbent cartridge of claim 3, wherein said zirconium phosphate has at least one of the following characteristics:

a) an adsorption capacity for ammonia of from about 20 mg NH₄-N/gm ZrP to about 45 mg NH₄-N/gm ZrP;

an adsorption capacity for Ca²⁺ of from about 2 mEq Ca²⁺/gm ZrP to about 7 mEq Ca²⁺/gm ZrP;

an adsorption capacity for Mg²⁺ of from about 1 mEq Mg²⁺/gm ZrP to about 5 mEq Mg²⁺/gm ZrP; and

an adsorption capacity for toxic heavy metals of from about 3 mEq HM/gm ZrP to about 9 mEq HM/gm ZrP;

b) a Na⁺ content of from about 1.8 mEq Na⁺/gm ZrP to about 3 mEq Na⁺/gm ZrP at a pH of from about 5.5 to about 6;

c) a minimum leachable PO₄³⁻

of less than about 0.05 mg PO₄³⁻

/gm ZrP;

or

d) satisfying ANSI/AAMI RD-5-1992 standard on extractable toxic impurities.

7. The sorbent cartridge of claim 5, wherein said zirconium phosphate has no residual sulfate or chloride.

8. The sorbent cartridge of claim 5, wherein said zirconium phosphate has less than 0.01% sulfate, chloride, or both.

9. The sorbent cartridge of claim 3, wherein said zirconium phosphate in H₂O has a pH of from about 6 to about 7.

10. The sorbent cartridge of claim 3, wherein said zirconium phosphate has an average grain size of from about 30 to about 40 microns.

13. The sorbent cartridge of claim 1, further comprising alumina, alumina supported urease, granular activated carbon, or combinations thereof.

14. The sorbent cartridge of claim 13, wherein said alumina, alumina supported urease, and granular activated carbon are each present as separate layers in said sorbent cartridge.

15. The sorbent cartridge of claim 14, wherein said layers have the following order:

a) said sodium zirconium carbonate;

b) a zirconium phosphate;

c) said alumina;

d) said alumina supported urease;

e) said granular activated carbon.

16. The sorbent cartridge of claim 15, wherein said sorbent cartridge further comprises a first filter pad located above and in contact with said sodium zirconium carbonate, a second filter pad is located between and in contact with said alumina supported urease and said granular activated carbon, and a third filter pad is located beneath and in contact with said granular activated carbon.

17. The sorbent cartridge of claim 16, further comprising a flow diffuser located beneath and in contact with said third filter pad.

18. The sorbent cartridge of claim 1, wherein said sodium zirconium carbonate comprises from about 2 wt % to about 5 wt % Na⁺;

from about 44 wt % to about 50 wt % ZrO₂;

from about 12 wt % to about 18 wt % CO₃²⁻

; and

from about 30 wt % to about 40 wt % LOD, based on the weight of the sodium zirconium carbonate.

19. The sodium zirconium carbonate of claim 1, wherein said sodium zirconium carbonate satisfies ANSI/AAMI RD-5-1992 standard on extractable toxic impurities.

20. The sodium zirconium carbonate of claim 1, wherein said sodium zirconium carbonate satisfies at least one of the following characteristics:

a phosphate adsorption having a minimum capacity of from about 30 to about 35 mgPO₄-P/gm SZC;

a minimum HCO₃⁻

content of from about 2 to about 4 mEq HCO₃⁻

per gm SZC;

a leachable Na⁺ content of from about 1.5 to about 2.0 mEq Na⁺/gm SZC;

or a pH range of titrated sodium zirconium carbonate of from about 6 to about 7.

21. The sorbent cartridge of claim 1, further comprising hydrous zirconium oxide.

22. The sorbent cartridge of claim 21, wherein said hydrous zirconium oxide is in the acetate form.

23. The sorbent cartridge of claim 22, wherein said sodium zirconium carbonate and said hydrous zirconium oxide are present in a weight ratio of about 1 to 1.

24. The sorbent cartridge of claim 22, wherein said sodium zirconium carbonate and said hydrous zirconium oxide are present in a same layer and are blended together.

25. The sorbent cartridge of claim 1, further comprising zirconium basic carbonate.

26. The sorbent cartridge of claim 25, wherein said zirconium basic carbonate comprises Na⁺ of less than about 1000 ppm;

a ZrO₂ wt % of from about 35 wt % to about 40 wt%;

and a CO₃²⁻

of from about 8 wt % to about 10 wt %, based on the weight of the zirconium basic carbonate.

27. The sorbent cartridge of claim 26, wherein said zirconium basic carbonate has about 0 wt % SO₄²⁻

and about 0 wt % Cl⁻

.

28. The sorbent cartridge of claim 1, wherein said sodium zirconium carbonate is present in said cartridge in an amount of from about 100 grams to about 300 grams.

29. The sorbent cartridge of claim 28, wherein said cartridge further comprises zirconium phosphate in an amount of from about 300 grams to about 1900 grams.

30. The sorbent cartridge of claim 29, further comprising alumina in the amount of from about 100 grams to about 500 grams, immobilized enzyme in an amount of from about 100 grams to about 300 grams, and activated carbon or other adsorbent in an amount of from about 100 grains to about 500 grams.

31. The sorbent cartridge of claim 1, further comprising an immobilized enzyme material capable of enzymatic conversion of urea to ammonium carbonate, a cation exchange material in the sodium or hydrogen form, an anion exchange material in the Ac⁻

, HCO₃⁻

, Cl⁻

, or OH⁻

form, and an adsorbent capable of removing creatinine, uric acid, or both.

32. The sorbent cartridge of claim 31, further comprising a chlorine removal material.

33. The sorbent cartridge of claim 32, wherein the materials are present as two or more layers in said cartridge.

34. The sorbent cartridge of claim 32, wherein the materials are present as two or more layers in said cartridge.

38. A method to regenerate or purify spent dialysis fluid comprising passing said spent dialysis fluid through the sorbent cartridge of claim 1.

39. A method to regenerate or purify spent dialysis fluid comprising passing said spent dialysis fluid through the sorbent cartridge of claim 3.

40. A method to regenerate or purify spent dialysis fluid comprising passing said spent dialysis fluid through the sorbent cartridge of claim 4.

41. A method to regenerate or purify spent dialysis fluid comprising passing said spent dialysis fluid trough the sorbent cartridge of claim 5.

42. A method to regenerate or purify spent dialysis fluid comprising passing said spent dialysis fluid through the sorbent cartridge of claim 6.

45. A method to regenerate or purify spent dialysis fluid comprising passing said spent dialysis fluid through the sorbent cartridge of claim 15.

46. An apparatus for conducting dialysis comprising the sorbent cartridge of claim 1, a dialyzer in fluid communication with said cartridge wherein spent dialysis fluid passes from said dialyzer to and through said cartridge.

47. The apparatus of claim 46, wherein said spent dialysis fluid is spent hemodialysis fluid.

48. The apparatus of claim 46, wherein spent dialysis fluid is restored to original balance of Na⁺ and HCO₃⁻

contents found in fresh dialysate.

49. The apparatus of claim 46, wherein said dialyzer is in fluid communication with the blood of a patient.

50. The apparatus of claim 49, wherein the Na⁺ and HCO₃⁻

balance in said blood is restored to levels found in healthy patient without renal problems.

51. The apparatus of claim 46, wherein said spent dialysis fluid is spent dialysate fluid obtained from a dialyzer wherein spent peritoneal dialysis fluid is passed through said dialyzer and cleaned by fresh dialysate fluid.

52. A dialysis system comprising the sorbent cartridge of claim 1 and a source of spent peritoneal dialysis solution, wherein the source of said spent peritoneal dialysis solution is in fluid communication with said cartridge wherein said spent peritoneal dialysis solution passes to and through said cartridge.

53. The sorbent cartridge of claim 1, wherein said cartridge is capable of restoring the balance of Na⁺ and HCO₃⁻

in spent dialysate to levels found in fresh dialysate.

54. The sorbent cartridge of claim 5, wherein said cartridge is capable of restoring the balance of Na⁺ and HCO₃⁻

in spent dialysate to levels found in fresh dialysate.

55. The sorbent cartridge of claim 30, wherein said cartridge is capable of restoring the balance of Na⁺ and HCO₃⁻

in spent dialysate to levels found in fresh dialysate.

56. The sorbent cartridge of claim 3, wherein said zirconium phosphate is further away from an inlet opening of said sorbent cartridge than said layer of sodium zirconium carbonate.

57. The sorbent cartridge of claim 4, wherein said layer of zirconium phosphate is further away from an inlet opening of said sorbent cartridge than said layer of sodium zirconium carbonate.

11. A sorbent cartridge comprising an alkali metal-Group IV B metal carbonate, wherein said alkali metal-Group IV B metal carbonate is present as a layer in said sorbent cartridge.

12. The sorbent cartridge of claim 11, further comprising a Group IV B metal phosphate.

35. The sorbent cartridge of claim 11, further comprising an immobilized enzyme material capable of enzymatic conversion of urea to ammoniuin carbonate, a cation exchange material in the sodium or hydrogen form, an anion exchange material in the Ac⁻

, HCO₃⁻

, Cl⁻

, or OH⁻

form, and an adsorbent capable of removing creatinine, uric acid, or both.

36. The sorbent cartridge of claim 11, further comprising a chlorine removal material.

37. The sorbent cartridge of claim 11, wherein the materials are present as two or more layers in said cartridge.

43. A method to regenerate or purify spent dialysis fluid comprising passing said spent dialysis fluid through the sorbent cartridge of claim 11.

44. (withdrawn):

A method to regenerate or purify spent dialysis fluid comprising passing said spent dialysis fluid through the sorbent cartridge of claim 12.