PH and buffer management system for hemodialysis systems

Patent metadata

Field	Value
Publication number	US-12440612-B2
Application number	US-202217974484-A
Country	US
Kind code	B2
Filing date	Oct 26, 2022
Priority date	Dec 10, 2012
Publication date	Oct 14, 2025
Grant date	Oct 14, 2025

Abstract

Systems and methods for managing the pH of a dialysate fluid during hemodialysis therapy. The systems and methods adjust dialysate pH and buffer concentration to generate a predetermined total bicarbonate buffer concentration in a dialysate entering a dialyzer. The systems and methods generate a pH-modifying fluid and selectively add the pH modifying fluid to the dialysate in order to accurately control the total bicarbonate buffer concentration in the dialysate entering the dialyzer.

First claim

What is claimed is:

1. A system comprising:
a dialysate flow loop for circulating a dialysate through a dialyzer,
wherein the dialysate flow loop comprises a dialysate regeneration unit having a sorbent cartridge;

a pH-buffer management system for adding or generating a pH-buffer modifying solution to the dialysate,
wherein the pH-buffer modifyinq solution has a different pH from the dialysate;
wherein the pH-buffer management system comprises a bipolar electrodialysis system for at least acidifying the dialysate;

a degasser module configured to remove at least carbon dioxide generated by the bipolar electrodialysis system; and
a controller programmed for calculating an amount of the pH-buffer modifying solution for addition to the dialysate to adjust the dialysate to be of a predetermined pH and bicarbonate buffer concentration,
wherein the controller is further programmed to determine an amount of bicarbonate generated by the dialysate regeneration unit due to a urea concentration of the dialysate upstream of the dialysate regeneration unit.

2. The system of claim 1 , wherein the pH-buffer management system comprises an infusate system configured to add a bicarbonate buffer component or unbuffered sodium bicarbonate to the dialysate.

3. The system of claim 1 , wherein the controller is programmed to determine the predetermined pH and bicarbonate buffer concentration based at least in part on an acid/base chemistry of a patient.

4. The system of claim 1 , wherein a feed into the bipolar electrodialysis system comprises an ultrafiltrate.

5. The system of claim 1 , wherein a feed into the bipolar electrodialysis system comprises a dialysate.

6. The system of claim 1 , wherein the controller is programmed to determine a pH and a buffer concentration of the dialysate to determine an addition rate of the pH-buffer modifying solution into the dialysate.

7. The system of claim 1 , wherein the controller sets an addition rate of the pH-buffer modifying solution into the dialysate at least in part based on the amount of bicarbonate generated by the dialysate regeneration unit.

8. The system of claim 1 , wherein the degasser module removes carbon dioxide undissolved within the dialysate to a certain level to achieve a specific dialysate pH.

9. The system of claim 1 , wherein the degasser module removes carbon dioxide dissolved within the dialysate to a certain level to achieve a specific dialysate pH.

10. A method comprising:
adding a pH-buffer modifying solution into a dialysate in a dialysate flow loop downstream of a dialyzer and upstream of a dialysate regeneration unit comprising a sorbent cartridge,
wherein an addition rate of the pH-buffer modifying solution into the dialysate is set to adjust the dialysate to be of a predetermined pH and bicarbonate buffer concentration;
wherein the pH-buffer modifying solution is added from a pH-buffer management system,
wherein the pH-buffer management system comprises a bipolar electrodialysis system for at least acidifying the dialysate;

determining an amount of bicarbonate generated by the dialysate regeneration unit due to a urea concentration of the dialysate upstream of the dialysate regeneration unit; and
removing, via a deqasser, carbon dioxide generated by the bipolar electrodialysis system from the dialysate.

11. The method of claim 10 , wherein the pH-buffer management system comprises an infusate system configured to add a bicarbonate buffer component or unbuffered sodium bicarbonate to the dialysate.

12. The method of claim 10 , further comprising determining the predetermined pH and bicarbonate buffer concentration based at least in part on an acid/base chemistry of a patient.

13. The method of claim 10 , wherein a feed into the bipolar electrodialysis system comprises an ultrafiltrate.

14. The method of claim 10 , wherein a feed into the bipolar electrodialysis system comprises a dialysate.

15. The method of claim 10 , further comprising determining a pH and a buffer concentration of the dialysate prior to addition of the pH-buffer modifying solution to determine an addition rate of the pH-buffer modifying solution into the dialysate.

16. The method of claim 10 , further comprising setting an addition rate of the pH-buffer modifying solution into the dialysate at least in part based on the amount of bicarbonate generated by the dialysate regeneration unit.

17. A system comprising:
a dialysate flow loop for circulating a dialysate through a dialyzer,
wherein the dialysate flow loop comprises a dialysate regeneration unit having a sorbent cartridge;

a pH-buffer management system for adding a pH-buffer modifying solution to the dialysate,
wherein the pH-buffer modifying solution has a different pH from the dialysate;

a degasser module configured to remove carbon dioxide within the dialysate to a certain level to achieve a specific dialysate pH,
wherein the degasser module is downstream from the pH-buffer management system and the sorbent cartridge; and

a controller programmed for calculating an amount of the pH-buffer modifying solution for addition to the dialysate to adjust the dialysate to be of a predetermined pH and bicarbonate buffer concentration.

Assignees

• Mozarc Medical Us Llc

Inventors

• Pudil Bryant J
• Gerber Martin T
• Lura David B
• Meyer Thomas E

Classifications

• A61M1/3406

  Physical characteristics of the filtrate, e.g. urea · CPC title

• A61M2205/33

  Controlling, regulating or measuring · CPC title

• A61M2205/3324

  PH measuring means · CPC title

• A61M1/3437

  downstream of the filter, e.g. post-dilution with filtrate · CPC title

• A61M1/287

  Dialysates therefor · CPC title