pH buffer measurement system for hemodialysis systems

• US 9,827,361 B2
• Filed: 03/15/2013
• Issued: 11/28/2017
• Est. Priority Date: 02/02/2013
• Status: Active Grant

• Current Assignee: Mozarc Medical US LLC
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Pudil, Bryant J., Meyer, Thomas E., Lura, David B., Gerber, Martin T.
• Primary Examiner(s): Clemente, Robert
• Assistant Examiner(s): VARMA, AKASH K
• Application Number:
  US13/837,287
• Publication Number:
  US 20140220699A1
• Time in Patent Office: 1,719 Days
• Field of Search: 210 962, 210647, 210743, 422 681, 436163, 604 29
• CPC Class Codes: A61M 1/1605 Physical characteristics of the dialysate fluid
• CPC Class Codes: A61M 1/1656 Apparatus for preparing dialysates
• CPC Class Codes: A61M 1/1658 Degasification
• CPC Class Codes: A61M 1/1668 Details of containers
• CPC Class Codes: A61M 1/1696 with dialysate regeneration
• CPC Class Codes: A61M 1/287 Dialysates therefor
• CPC Class Codes: A61M 2205/3317 Electromagnetic, inductive or dielectric measuring means
• CPC Class Codes: A61M 2205/7518 bacterial
• CPC Class Codes: G01N 33/84 involving inorganic compounds or pH

Abstract

A pH-buffer measurement system that has at least one source for modifying the pH of a fluid entering the system, the source selected from an acid source and a base source. The acid source adds an acid equivalent to provide an acid reacted fluid and the base source adds a base equivalent to provide a base reacted fluid. The source is in fluid communication with a flow path and a component for determining a fluid characteristic of the acid reacted fluid or the base reacted fluid. The fluid characteristic that is measured is any one of a gas phase pressure, an electrical conductivity, or thermal conductivity.

Claims

1. A pH-buffer measurement system for a dialysis system, comprising:

at least one source for modifying the pH of a fluid entering the pH-buffer measurement system, wherein at least one source for modifying the pH is selected from an acid source and a base source, and wherein the acid source adds an acid equivalent to provide an acid reacted fluid and the base source adds a base equivalent to provide a base reacted fluid, and wherein the at least one source is in fluid communication with a dialysate flow path; and

a component, positioned downstream of the at least one source for modifying the pH of the fluid entering the pH-buffer measurement system, for determining a fluid characteristic of the acid reacted fluid or the base reacted fluid;

wherein the fluid characteristic that is measured is any one of a gas phase pressure, an electrical conductivity, or thermal conductivity,

a sorbent system in the dialysate flow path;

wherein the acid reacted fluid comprises at least a portion of the acid equivalent reacted with buffer in the fluid entering the pH-buffer measurement system, and the base reacted fluid comprises at least a portion of the base equivalent reacted with buffer in the fluid entering the pH-buffer measurement system.

2. The system of claim 1, wherein the component determines a fluid characteristic of an unreacted fluid.

3. The system of claim 1, further comprising a static mixer downstream from the at least one source for modifying the pH of the fluid entering the pH-buffer measurement system.

4. The system of claim 1, further comprising one or more pumps for pumping fluid into and out of the pH-buffer measurement system.

5. The system of claim 1, wherein the pH-buffer measurement system is configured to determine pH, buffer content, or both of the fluid by taking a difference between a first value of the fluid characteristic of the fluid entering the pH-buffer measurement system and a second value of the fluid characteristic of the acid reacted fluid or the base reacted fluid.

6. The system of claim 1, wherein the pH-buffer measurement system determines a pH, buffer content or both of the fluid by taking a difference between a first value of the fluid characteristic of the fluid entering the pH-buffer measurement system and a second value of the fluid characteristic of an unreacted fluid.

7. The system of claim 1, wherein the component measures a gas phase pressure in an area over the fluid entering the pH-buffer measurement system.

8. The system of claim 1, wherein the component measures a gas phase pressure in an area over the acid reacted fluid or the base reacted fluid.

9. The system of claim 1, wherein the component measures a gas phase thermal conductivity of the fluid entering the pH-buffer measurement system.

10. The system of claim 1, wherein the component measures a gas phase thermal conductivity of the acid reacted fluid or the base reacted fluid.

11. The system of claim 9 or 10, wherein the component measuring the thermal conductivity is configured to be flushed with a purge gas wherein the gas to be measured diffuses from the fluid entering the pH-buffer measurement system, the acid reacted fluid, or the base reacted fluid through a membrane changing the thermal conductivity of a gas surrounding an electrode.

12. The system of claim 11, wherein a rate of change of the thermal conductivity is used to calculate a concentration of a gas.

13. The system of claim 1, wherein the component is configured to measure an electrical conductivity of the acid reacted fluid or the base reacted fluid.

14. The system of claim 1, wherein the component is configured to measure an electrical conductivity of the fluid entering the pH-buffer measurement system.

15. The system of claim 1, wherein the fluid entering the pH-buffer measurement system is dialysate.

16. The system of claim 1, wherein the fluid characteristic comprises a buffer content to be measured, and wherein the buffer content to be measured is bicarbonate content of the fluid.

17. The system of claim 1, wherein the acid source adds acid in a predetermined amount to ensure complete conversion of bicarbonate in the fluid entering the pH-buffer measurement system.

18. The system of claim 1, wherein the acid source adds at least one of acetic acid, citric acid, hydrochloric acid, and phosphoric acid.

19. The system of claim 1, wherein the component has a first measurement chamber to measure a gas phase pressure of the acid reacted fluid or the base reacted fluid, and a second measurement chamber to measure a gas phase pressure of the fluid entering the pH-buffer measurement system.

20. The system of claim 19, further comprising a differential pressure sensor in fluid communication with the first and second measurement chambers.

21. The system of claim 19, wherein the first or second measurement chamber has an air-gap above a gas permeable membrane in fluid communication with a pressure transducer and a vent valve to allow gas to escape from the first or second measurement chamber wherein the pressure transducer measures a pressure of the gas phase above any one of the acid reacted fluid, the base reacted fluid, or the fluid entering the pH-buffer measurement system.

22. The system of claim 1, further comprising a control system to perform calculations necessary for determining the fluid characteristic based on any one of the acid reacted fluid, the base reacted fluid, or the fluid entering the pH-buffer measurement system.

23. A fluid therapy system, comprising:

a dialyzer and a sorbent system in fluid communication with a pH-buffer measurement system to form a dialysate flow path;

wherein the pH-buffer measurement system comprises;

at least one source for modifying the pH of a fluid entering the pH-buffer measurement system, the at least one source selected from an acid source and a base source wherein the acid source adds an acid equivalent to provide an acid reacted fluid and the base source adds a base equivalent to provide a base reacted fluid wherein the at least one source is in fluid communication with the dialysate flow path; and

a component positioned downstream of the source for modifying the pH of the fluid entering the pH-buffer measurement system, for determining a fluid characteristic of the acid reacted fluid or the base reacted fluid;

wherein the fluid characteristic that is measured is any one of a gas phase pressure, an electrical conductivity, or thermal conductivity; and

a reconstitution system positioned downstream of the pH-buffer measurement system for providing a controlled amount of a buffer to be added to a dialysate to form a second dialysate with a predetermined concentration of the buffer prior to use in the dialyzer,

wherein the pH-buffer measurement system determines the pH, buffer concentration or both of any one of the acid reacted fluid, the base reacted fluid, or the fluid entering the pH-buffer measurement system.

24. The system of claim 23, wherein the buffer is bicarbonate.

25. The system of claim 23, wherein the pH-buffer measurement system is positioned downstream from the sorbent system and a degasser.

26. The system of claim 23, wherein the reconstitution system adjusts the pH and bicarbonate concentration to desired levels.

27. The system of claim 23, further comprising a conductivity sensor connected anywhere along the dialysate flow path.

28. The system of claim 23, wherein fluid in the dialysate flow path is selectively metered into and out of the dialysate flow path.

29. The system of claim 23, wherein the fluid therapy system is a controlled compliant system.

30. The system of claim 29, wherein fluid in the dialysate flow path is selectively metered into and out of the dialysate flow path.

31. The system of claim 23, wherein the fluid therapy system is used for any one of hemodialysis and hemofiltration.

32. A method for determining a pH or buffer content of a fluid in a dialysate flow path, comprising the step of:

modifying the pH of the fluid by adding an acid equivalent from an acid source to provide an acid reacted fluid or adding a base equivalent from a base source to provide a base reacted fluid; and

determining at least one fluid characteristic of the acid reacted fluid or the base reacted fluid by taking a difference between a first value of the fluid characteristic and a second value of the fluid characteristic of the acid reacted fluid or the base reacted fluid;

wherein at least one of the first value of the fluid characteristic and second value of the fluid characteristic is measured downstream of the acid source or the base source in the dialysate flow path, and

wherein the acid reacted fluid comprises at least a portion of the acid equivalent reacted with buffer in the fluid entering the pH-buffer measurement system, and the base reacted fluid comprises at least a portion of the base equivalent reacted with buffer in the fluid entering the pH-buffer measurement system.

33. The method of claim 32, further comprising the step of:

recirculating the acid reacted fluid or the base reacted fluid to allow complete reaction between bicarbonate and an acid to form carbon dioxide to form a recirculated fluid;

measuring the pressure of the recirculated fluid reading to determine an amount of carbon dioxide contained in the recirculated fluid.

34. The method of claim 32, further comprising the step of:

recirculating the fluid to determine total pressure of gases in equilibrium with the fluid, wherein the fluid is a dialysate;

acidifying the dialysate to convert all bicarbonate in the dialysate to carbon dioxide;

measuring a total pressure of gases in equilibrium with the dialysate with a pressure sensor; and

determining a partial pressure of carbon dioxide in the dialysate.

35. The method of claim 32, further comprising the step of flowing the fluid through a static mixer to enhance the mixing between the acid equivalent and the fluid, wherein the fluid is a dialysate.

36. The method of claim 34, further comprising the step of flowing the fluid through any one of a fluid path for hemodialysis, hemofiltration, hemodiafiltration and peritoneal dialysis.

37. A fluid therapy system comprising:

a fluid flow path in fluid communication with a dialyzer, a sorbent regeneration unit,

a fluid characteristic management unit, the fluid characteristic management unit being positioned between the sorbent regeneration unit and the dialyzer along a fluid flow, and

a reconstitution system positioned downstream of the fluid characteristic management unit.

38. The fluid therapy system of claim 37, wherein the fluid characteristic management unit is a pH-buffer management unit.

39. The fluid therapy system of claim 37, wherein the fluid characteristic management unit is a potassium management unit.

40. The fluid therapy system of claim 37, further comprising a degasser in fluid communication with the fluid flow path and being positioned downstream of the sorbent regeneration unit along the fluid flow.

41. The fluid therapy system of claim 37, further comprising a bypass flow path diverting a portion of the fluid flow from the fluid characteristic management unit.

42. The fluid therapy system of claim 37, further comprising a conductivity sensor in fluid communication with the fluid flow path and being positioned downstream of the fluid characteristic management unit along the fluid flow.

43. The fluid therapy system of claim 37, wherein the fluid characteristic management unit includes at least one of an inlet for an acid feed and an inlet for a base feed.

44. The fluid therapy system of claim 37, wherein the fluid characteristic management unit includes at least one of a thermal conductivity sensor and an electrical conductivity sensor.

45. The fluid therapy system of claim 37, further comprising a replacement flow loop in fluid communication with the fluid flow path and positioned downstream of the fluid characteristic management unit, the replacement flow loop transporting a portion of a regenerated fluid out of the sorbent regeneration unit directly into the blood of a subject and bypassing the dialyzer.

46. The fluid therapy system of claim 37, further comprising an open dialysate reservoir in fluid communication with the fluid flow path and being positioned upstream of the sorbent regeneration unit along the fluid flow.