Solutions, dialysates, and related methods

• US 8,182,692 B2
• Filed: 05/28/2008
• Issued: 05/22/2012
• Est. Priority Date: 05/29/2007
• Status: Active Grant

• Current Assignee: Fresenius Medical Care Holdings Incorporated (Fresenius Medical Care AG)
• Original Assignee: Fresenius Medical Care Holdings Incorporated (Fresenius Medical Care AG)
• Inventors: Gotch, Frank A.
• Primary Examiner(s): Kim, John
• Application Number:
  US12/128,167
• Publication Number:
  US 20080296226A1
• Time in Patent Office: 1,455 Days
• Field of Search: 210/645, 210/646, 210/647, 210/739, 210/745, 210/746, 210/85, 210/103, 210/134, 210/143, 604/4.01, 604/28, 422/68.1, 422/82.01, 422/82.02
• US Class Current: 210/646
• CPC Class Codes: A61K 2300/00 Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
• CPC Class Codes: A61K 33/00 Medicinal preparations containing inorganic active ingredients
• CPC Class Codes: A61K 45/06 Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
• CPC Class Codes: A61M 1/1607 before use, i.e. upstream of dialyser
• CPC Class Codes: A61M 1/1609 after use, i.e. downstream of dialyser
• CPC Class Codes: A61M 1/1613 Profiling or modelling of patient or predicted treatment evolution or outcome
• CPC Class Codes: A61M 1/1654 Dialysates therefor
• CPC Class Codes: A61M 1/1656 Apparatus for preparing dialysates

Abstract

Solutions, dialysates, and methods for measuring solutes in blood and/or for treating blood. In one aspect of the invention, a method of performing dialysis includes placing a solution in communication with blood of a subject, where a concentration of at least one electrically conductive solute in the solution, prior to being placed in communication with the blood of the subject, is substantially equal to a concentration of the at least one electrically conductive solute in the blood of the subject.

Claims

1. A method of performing dialysis, the method comprising:

prior to beginning dialysis treatment during which dialysate is placed in communication with blood of a subject, placing a test solution in communication with the blood of a the subject, wherein a concentration of at least one electrically conductive solute in the test solution, prior to being placed in communication with the blood of the subject, is substantially equal to a concentration of the at least one electrically conductive solute in the blood of the subject.

2. The method of claim 1, wherein placing the test solution in communication with the blood of the subject comprises passing the test solution through a dialyzer.

3. The method of claim 1, wherein the at least one electrically conductive solute comprises one or more members selected from the group consisting of phosphate, sulfate, bicarbonate, potassium, calcium, and magnesium.

4. The method of claim 1, wherein the at least one electrically conductive solute comprises phosphate, sulfate, bicarbonate, potassium, calcium, and magnesium.

5. The method of claim 1, further comprising, after placing the test solution in communication with the blood of the subject, measuring a conductivity of the test solution and determining a concentration of sodium in the blood of the subject as a function of the measured conductivity of the solution.

6. The method of claim 5, further comprising placing the dialysate in communication with the blood of the subject, the dialysate having a concentration of sodium that is substantially equal to the determined concentration of sodium in the blood.

7. The method of claim 6, wherein placing the dialysate in communication with the blood of the subject comprises passing the dialysate through a dialyzer.

8. A method of performing dialysis, the method comprising:

prior to beginning dialysis treatment during which dialysate is placed in communication with blood of a subject, measuring an electrical conductivity of a test solution in communication with the blood of the subject, a concentration of at least one electrically conductive solute in the test solution, prior to being placed in communication with the blood of the subject, being substantially equal to a concentration of the at least one electrically conductive solute in the blood of the subject;

determining a sodium concentration of the blood of the subject as a function of the measured electrical conductivity of the test solution; and

placing the dialysate in communication with the blood of the subject to perform the dialysis treatment, the dialysate, prior to being placed in communication with the blood of the subject, having a sodium concentration that is substantially equal to the determined sodium concentration of the blood of the subject.

9. The method of claim 8, wherein the sodium concentration of the dialysate differs from the determined sodium concentration of the blood by no more than about five percent of the determined sodium concentration.

10. The method of claim 8, wherein the sodium concentration of the dialysate differs from the determined sodium concentration of the blood by no more than about 7.5 mEq/L.

11. The method of claim 8, further comprising preparing the dialysate by combining a dialysate concentrate with water.

12. The method of claim 8, wherein the at least one electrically conductive solute comprises one or more members selected from the group consisting of phosphate, sulfate, bicarbonate, potassium, calcium, and magnesium.

13. The method of claim 8, wherein placing the dialysate in communication with the blood of the subject comprises passing the dialysate through a dialyzer.

14. The method of claim 13, further comprising passing the test solution through the dialyzer prior to passing the dialysate through the dialyzer.

15. The method of claim 14, wherein the test solution is passed through the dialyzer for substantially less time than the dialysate is passed through the dialyzer.

16. The method of claim 15, wherein the test solution is passed through the dialyzer for about five minutes or less.

17. The method of claim 13, wherein a sodium concentration in the blood of the subject, after passing the dialysate through the dialyzer for a predetermined period of time, differs from the determined sodium concentration of the blood of the subject by no more than about five percent of the determined sodium concentration of the blood of the subject.

18. A method of performing dialysis, the method comprising:

prior to beginning dialysis treatment during which dialysate is placed in communication with blood of a dialysis patient across a semi-permeable membrane, placing a test solution in communication with the dialysis patient'"'"'s blood across the semi-permeable membrane for sufficient time to cause sodium ions from the patient'"'"'s blood to migrate across the membrane into the test solution, the test solution, prior to being placed in communication with the patient'"'"'s blood, comprising concentrations of conductive solutes approximately matching expected concentrations of corresponding conductive solutes in the patient'"'"'s blood and having a sodium concentration that is lower than an expected sodium concentration of the patient'"'"'s blood;

measuring conductivity of the test solution both before and after the test solution is placed in communication with the patient'"'"'s blood;

estimating a current concentration of sodium in the patient'"'"'s blood as a function of a differential between the conductivity of the test solution before being placed in communication with the patient'"'"'s blood and the conductivity of the test solution after being placed in communication with the patient'"'"'s blood;

providing a dialysate having a sodium concentration substantially equal to the estimated current sodium concentration in the patient'"'"'s blood; and

placing the dialysate in communication with the patient'"'"'s blood across the semi-permeable membrane to perform a the dialysis treatment on the patient'"'"'s blood without substantially altering the sodium concentration of the patient'"'"'s blood during the performance of the dialysis treatment.

19. The method of claim 18, further comprising:

measuring conductivities of the dialysate before and after the dialysate is placed in communication with the patient'"'"'s blood; and

adjusting the sodium concentration of the dialysate during the dialysis treatment as a function of the before and after conductivities of the dialysate in order to substantially maintain the same sodium level in the patient'"'"'s blood throughout the dialysis treatment.

20. The method of claim 18, further comprising preparing the test solution.

21. The method of claim 20, wherein preparing the test solution comprises determining average levels of conductive solutes in blood of a population of subjects and preparing the test solution to have levels of conductive solutes that substantially match the average levels of conductive solutes in the blood of the population of subjects.

22. The method of claim 18, further comprising preparing the dialysate.

23. The method of claim 22, wherein preparing the dialysate comprises determining an actual concentration of a dialysate concentrate, and combining the dialysate concentrate with an amount of water, the amount of water being determined as a function of the actual concentration of the dialysate concentrate.

24. The method of claim 23, wherein the actual concentration of the dialysate concentrate is determined as a function of a measured conductivity of the dialysate concentrate.

25. The method of claim 18, wherein the at least one electrically conductive solute comprises phosphate, sulfate, bicarbonate, potassium, calcium, and magnesium.

26. The method of claim 18, wherein the conductive solutes comprises phosphate, sulfate, bicarbonate, potassium, calcium, and magnesium.