Bicarbonate sensor for dialysis

Patent metadata

Field	Value
Publication number	US-12433976-B2
Application number	US-201916691871-A
Country	US
Kind code	B2
Filing date	Nov 22, 2019
Priority date	Jan 8, 2019
Publication date	Oct 7, 2025
Grant date	Oct 7, 2025

Abstract

The invention relates to devices, systems, and methods for calculating a bicarbonate concentration in a fluid used in dialysis. The devices, systems, and methods can be used to calculate the bicarbonate concentration in either dialysate or blood. The invention measures the amount of carbon dioxide in both an acidified and non-acidified solution and calculates the bicarbonate concentration based on the difference in carbon dioxide concentrations.

First claim

We claim:

1. A system, comprising:
a dialysate flow path for use in dialysis, the dialysate flow path comprising a sorbent line comprising a sorbent cartridge, the dialysate flow path further comprising a bypass line configured to bypass the sorbent cartridge, the bypass line comprising an upstream end being upstream of the sorbent cartridge and a downstream end being downstream of the sorbent cartridge, the upstream end of the bypass line being coupled to the sorbent line at a first sorbent line location and the downstream end of the bypass line being coupled to the sorbent line at a second sorbent line location spaced from the first sorbent line location along the sorbent line;
a first fluid line fluidly connected to the dialysate flow path;
an acid source fluidly connected to the first fluid line;
at least one carbon dioxide sensor fluidly connected to the first fluid line upstream of the upstream end of the bypass line or downstream of the downstream end of the bypass line, the at least one carbon dioxide sensor being an infrared sensor, a thermal conductivity sensor, or a chemical carbon dioxide sensor, an entire portion of the sorbent line between the first sorbent line location and the second sorbent line location being fluidly unconnected to the at least one carbon dioxide sensor; and
a processor in communication with the at least one carbon dioxide sensor; the processor programmed to:
recirculate a dialysate in the bypass line of the dialysate flow path through a dialyzer without passing the dialysate through the sorbent line comprising the sorbent cartridge until the dialysate equilibrates with blood of a patient;
measure, after the dialysate equilibrates with the blood, the amount of carbon dioxide in the dialysate in an acidified solution and in a non-acidified solution using the at least one carbon dioxide sensor;
calculate, after the dialysate equilibrates with the blood, a total carbon dioxide and/or bicarbonate concentration in the dialysate based on the measured amount of carbon dioxide in the acidified solution and in the non-acidified solution; and
adjust the calculated total carbon dioxide and/or bicarbonate concentration based on a temperature and/or a conductivity of the dialysate.

2. The system of claim 1 , further comprising a mixer fluidly connecting the dialysate flow path to the first fluid line, the acid source fluidly connected to the mixer.

3. The system of claim 1 , wherein the at least one carbon dioxide sensor comprises a first carbon dioxide sensor and a second carbon dioxide sensor; wherein the first carbon dioxide sensor is configured to measure the amount of carbon dioxide in the acidified solution; and wherein the second carbon dioxide sensor is configured to measure the amount of carbon dioxide in the non-acidified solution.

4. The system of claim 1 , wherein the first fluid line is downstream of the dialyzer, and wherein the system is configured to measure the total carbon dioxide and/or bicarbonate concentration in the blood returned to the patient.

5. The system of claim 1 , wherein the processor is programmed to calculate the bicarbonate concentration of the dialysate based on an equation: [HCO 3 ]=α*(pCO 2a −pCO 2n ); wherein [HCO 3 ] is the bicarbonate concentration of the dialysate, a is Henry's law constant for CO 2 in the dialysate, pCO 2a is a partial pressure of carbon dioxide in the acidified solution, and pCO 2n is a partial pressure of carbon dioxide in the non-acidified solution, and the value of α is adjusted based on the temperature and/or the conductivity of the dialysate.

6. The system of claim 5 , further comprising either or both of an electrical conductivity sensor configured to measure an electrical conductance of the dialysate or the temperature sensor configured to measure a temperature of the dialysate.

7. The system of claim 6 , wherein the processor is programmed to calculate α based on the electrical conductance and/or the temperature of the dialysate.

8. The system of claim 1 , wherein the at least one carbon dioxide sensor is the chemical carbon dioxide sensor.

9. A method, comprising:
recirculating a dialysate in a bypass line of a dialysate flow path through a dialyzer without passing through a sorbent line comprising a sorbent cartridge until the dialysate equilibrates with blood of a patient, the bypass line comprising an upstream end being upstream of the sorbent cartridge and a downstream end being downstream of the sorbent cartridge, the upstream end of the bypass line being coupled to the sorbent line at a first sorbent line location and the downstream end of the bypass line being coupled to the sorbent line at a second sorbent line location spaced from the first sorbent line location along the sorbent line;
taking, after the dialysate equilibrates with the blood, a first carbon dioxide measurement of the dialysate in the dialysate flow path without acidification of the dialysate using a carbon dioxide sensor being an infrared sensor, a thermal conductivity sensor, or a chemical carbon dioxide sensor, the carbon dioxide sensor being upstream of the upstream end of the bypass line or downstream of the downstream end of the bypass line, an entire portion of the sorbent line between the first sorbent line location and the second sorbent line location being fluidly unconnected to the carbon dioxide sensor;
acidifying at least a portion of the dialysate in the dialysate flow path;
taking a second carbon dioxide measurement of the dialysate in the dialysate flow path after acidification of the dialysate and after the dialysate equilibrates with the blood;
calculating, after the dialysate equilibrates with blood, a total carbon dioxide and/or bicarbonate concentration in the dialysate based on the first carbon dioxide measurement and the second carbon dioxide measurement; and
adjusting the calculated total carbon dioxide and/or bicarbonate concentration based on a temperature and/or a conductivity of the dialysate.

10. The method claim 9 , wherein the dialysate is acidified by introducing the dialysate to a mixer and introducing an acid solution to the mixer.

11. The method of claim 9 , wherein the second carbon dioxide measurement is measured by the carbon dioxide sensor.

12. The method of claim 9 , wherein the carbon dioxide sensor is a first carbon dioxide sensor, and wherein the second carbon dioxide measurement is measured by a second carbon dioxide sensor.

13. The method of claim 9 , wherein calculating the bicarbonate concentration in the dialysate comprises using an equation [HCO 3 ]=α*(pCO 2a −pCO 2n ); wherein [HCO 3 ] is the bicarbonate concentration of the dialysate, a is Henry's law constant for CO 2 in the dialysate, pCO 2a is a partial pressure of carbon dioxide in the dialysate after acidification, and pCO 2n is a partial pressure of carbon dioxide in the dialysate without acidification.

14. The method of claim 9 , further comprising measuring electrical conductivity and/or the temperature of the dialysate.

15. The method of claim 14 , further comprising calculating a based on the electrical conductivity and/or the temperature of the fluid.

16. The method of claim 9 , further comprising the step of returning the dialysate to the dialysate flow path after measuring an amount of carbon dioxide in the dialysate.

17. The method of claim 9 , wherein the first carbon dioxide measurement and second carbon dioxide measurement are measured with the chemical carbon dioxide sensor.

18. The method of claim 9 , wherein calculating the total carbon dioxide and/or bicarbonate

Assignees

• Mozarc Medical Us Llc

Inventors

• Grovender Eric A
• Meyer Thomas E
• Pudil Bryant J

Classifications

• A61M2205/3368

  Temperature · CPC title

• A61M2202/0225

  Carbon oxides, e.g. Carbon dioxide · CPC title

• A61M2202/0014

  removed from the body · CPC title

• A61M1/30

  Single needle dialysis {; Reciprocating systems, alternately withdrawing blood from and returning it to the patient, e.g. single-lumen-needle dialysis or single needle systems for hemofiltration or pheresis} · CPC title

• A61M1/1696

  with dialysate regeneration · CPC title