Recirculating dialysate fluid circuit for blood measurement

• US 9,713,666 B2
• Filed: 03/15/2013
• Issued: 07/25/2017
• Est. Priority Date: 01/09/2013
• 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): Kim, John
• Application Number:
  US13/836,538
• Publication Number:
  US 20140190886A1
• Time in Patent Office: 1,593 Days
• CPC Class Codes: A61M 1/14 Dialysis systems; Artificial kidneys; Blood oxygenators semi-permeable membranes characterised by the material, manufacturing processes therefor B01D71/00 ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
• CPC Class Codes: A61M 1/1605 Physical characteristics of the dialysate fluid
• 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 1/1619 Sampled collection of used dialysate, i.e. obviating the need for recovery of whole dialysate quantity for post-dialysis analysis
• CPC Class Codes: A61M 1/165 with a dialyser bypass on the dialysis fluid line
• CPC Class Codes: A61M 1/1694 with recirculating dialysing liquid
• CPC Class Codes: A61M 1/1696 with dialysate regeneration
• CPC Class Codes: A61M 1/28 Peritoneal dialysis ; Other peritoneal treatment, e.g. oxygenation
• CPC Class Codes: A61M 1/3406 Physical characteristics of the filtrate, e.g. urea
• CPC Class Codes: A61M 1/3472 with treatment of the filtrate
• CPC Class Codes: A61M 1/3486 Biological, chemical treatment, e.g. chemical precipitation; treatment by absorbents
• CPC Class Codes: A61M 2202/0498 Urea
• CPC Class Codes: A61M 2205/05 combined with other kinds of therapy
• CPC Class Codes: A61M 2205/15 Detection of leaks
• CPC Class Codes: A61M 2205/3317 Electromagnetic, inductive or dielectric measuring means
• CPC Class Codes: A61M 2205/3324 PH measuring means
• CPC Class Codes: A61M 2205/3334 Measuring or controlling the flow rate
• CPC Class Codes: B01D 15/08 Selective adsorption, e.g. chromatography
• CPC Class Codes: B01D 15/362 Cation-exchange

Abstract

A blood based solute monitoring system for measuring at least one blood solute species that has a first recirculation flow path in fluid communication with a dialyzer. The first recirculation flow path is configured to allow a fluid to recirculate through a dialyzer such that the concentration of at least one solute species in the fluid becomes equilibrated to the solute species concentration of the blood in a blood compartment of the dialyzer. The blood solute monitoring system has at least one sensor to measure a fluid characteristic.

Claims

1. A blood based solute monitoring system for measuring at least one blood solute species, comprising:

a first recirculation flow path in fluid communication with a dialyzer;

one or more valves configurable in a closed status to recirculate fluid through the first recirculation flow path and in an open status to recirculate fluid in a second flow path;

wherein the dialyzer comprises at least one semi-permeable membrane;

wherein the first recirculation flow path in the closed status recirculates the fluid through the dialyzer to equilibrate a concentration of at least one solute species in the fluid to a solute species concentration of the blood in a blood compartment of the dialyzer;

the first recirculation flow path having a pump and at least one sensor positioned in the first recirculation flow path measuring the concentration of the at least one solute species in the fluid wherein the sensor is located upstream of the dialyzer and downstream of a dialysate regeneration unit, the sensor measuring a change of the concentration of the fluid after passing the regeneration unit; and

the one or more valves in a non-closed status passing the fluid through the dialyzer wherein the at least one solute species in the fluid does not become equilibrated with the concentration of the solute species with the solute species in the blood in the blood compartment of the dialyzer.

2. The blood based solute monitoring system of claim 1, further comprising a valve diverting the fluid from the first recirculation flow path to the second flow path.

3. The blood based solute monitoring system of claim 1, wherein the second flow path is a sorbent regenerated dialysate flow path.

4. The blood based solute monitoring system of claim 1, wherein the second flow path is a controlled compliant flow path.

5. The blood based solute monitoring system of claim 1, wherein the first recirculation flow path has a volume of between 0.5 and 6 L and a control valve for selectively metering fluid in and out of the first recirculation flow path.

6. The blood based solute monitoring system of claim 1, further comprising any one of a control pump, a water pump, an acid concentrate pump, a replacement fluid pump, and combinations thereof;

the control pump selectively metering fluid into and out of the first recirculation flow path.

7. The blood based solute monitoring system of claim 1, wherein the first recirculation flow path moves fluid bi-directionally.

8. The blood based solute monitoring system of claim 5, wherein the first recirculation flow path is in fluid communication with a REDY system.

9. The blood based solute monitoring system of claim 1, further comprising a sorbent cartridge and a dialyzer bypass;

and a controller determining a baseline concentration based on a concentration in the fluid;

the controller further determining a solute concentration profile.

10. The blood based solute monitoring system of claim 1, further comprising a control mechanism equilibrating the solute concentration in less than any one of 10 minutes, 7 minutes, 5 minutes, 3 minutes, 2 minutes, and 1 minute.

11. The blood based solute monitoring system of claim 1, further comprising a control mechanism decreasing equilibration time by increasing dialysate and/or blood flow during fluid flow through the first recirculation flow path.

12. The blood based solute monitoring system of claim 1, further comprising a control mechanism decreasing equilibration time by performing ultrafiltration during fluid flow through the first recirculation flow path with or without increased rate of fluid flows.

13. The blood based solute monitoring system of claim 1, wherein the first recirculation flow path has a void volume of components and conduits of less than a volume from the group consisting of 1.0 L, 0.5 L, 0.4 L, 0.3 L, 0.2 L, and 0.1 L.

14. The blood based solute monitoring system of claim 1 further comprising a valve, wherein operation of the valve determines whether the fluid flows through the first recirculation flow path or the second flow path.

15. The blood based solute monitoring system of claim 1, further comprising a pump, wherein operation of the pump causes the fluid to flow through the first recirculation flow path.

16. The blood based solute monitoring system of claim 1, wherein the sensor is an ion selective sensor.

17. The blood based solute monitoring system of claim 1, further comprising at least two sensors to measure the fluid characteristic.

18. The blood based solute monitoring system of claim 17, wherein the at least two sensors include a conductivity sensor.

19. The blood based solute monitoring system of claim 17, wherein the at least two sensors include any one of a potassium sensor, a bicarbonate sensor, and an ammonia sensor.

20. The blood based solute monitoring system of claim 18 further comprising a conductivity sensor determining when equilibration with the blood has been achieved.

21. The blood based solute monitoring system of claim 18 wherein the conductivity sensor is a sodium concentration sensor in the blood.

22. The blood based solute monitoring system of claim 21, further comprising a sensor measuring a sodium concentration at the start of a therapy session;

and a controller determining a pre-dialysis blood sodium concentration of a subject;

the controller profiling the dialysate sodium concentration during the therapy session.

23. The blood based solute monitoring system of claim 1 or 17, wherein the at least one sensor is a pH sensor.

24. The blood based solute monitoring system of claim 1, wherein the blood solute monitoring system is in fluid communication with a controlled compliant flow path.

25. The blood based solute monitoring system of claim 1, further comprising a sorbent regeneration system for regenerating a dialysate and returning the dialysate to the dialyzer.

26. The blood based solute monitoring system of claim 25, wherein the first recirculation flow path through the dialyzer is not in communication with one or more material layers of the sorbent regeneration system.

27. The blood based solute monitoring system of claim 26, wherein at least one said material layer comprises one or more selected from a urease-containing material, alumina, zirconium phosphate, zirconium oxide, a divalent cation exchanger, activated carbon, and mixtures thereof.

28. The blood based solute monitoring system of claim 26, wherein at least one material layer containing urease is present in the first recirculation flow path.

29. The blood based solute monitoring system of claim 25, wherein the dialysate flowing in the first recirculation flow path contacts material layers within the sorbent regeneration system in a defined sequence.

30. The blood based solute monitoring system of claim 25, further comprising an electrolyte bolus injector.

31. The blood based solute monitoring system of claim 30, wherein the electrolyte bolus injector is located in the first recirculation flow path at a position downstream from a dialysate outlet of the dialyzer and upstream of the sorbent regeneration system, and the monitoring system monitors fluid at one or more positions in the first recirculation flow path selected from the group consisting of:

a first position downstream from the dialyzer outlet and downstream from the electrolyte bolus injector where the fluid has not contacted any material layer of the sorbent regeneration system;

a second position where the fluid has contacted a urease-containing material layer;

a third position where the fluid has contacted a material layer other than the urease-containing material layer; and

a fourth position in fluid communication with dialysate eluted from an outlet of the dialyzer and positioned upstream from the electrolyte bolus injector.

32. The blood based solute monitoring system of claim 31, wherein the fluid at the second position has only contacted the urease-containing material layer.

33. The blood based solute monitoring system of claim 31, wherein the blood solute monitoring system further measures the conductivity of the fluid at one or more positions within the controlled compliant flow path.

34. The blood based solute monitoring system of claim 31, further comprising at least one sensor to measure the conductivity of the fluid at one or more positions within the sorbent regeneration system.

35. The blood based solute based monitoring system of claim 1, further comprising one or more selected from the group consisting of:

an acid feed supplied to the controlled compliant flow path;

a bicarbonate feed; and

a water feed.

36. The blood based solute monitoring system of claim 1 for measuring the conductivity of a dialysate, further comprising:

a sorbent regeneration system having a plurality of material layers within the sorbent regeneration system, wherein the dialysate exiting a dialyzer is conveyed through the sorbent regeneration system.

37. The blood based solute monitoring system of claim 36, further comprising a controlled compliant flow path circulating the dialysate between the dialyzer and the sorbent regeneration system.

38. The blood based solute based monitoring system of claim 1 that forms part of a hemodialysis or hemodiafiltration system.

39. The blood based solute monitoring system of claim 1, wherein the dialysate regeneration unit is downstream of the dialyzer, and further comprising a sampling valve wherein the sampling valve is positioned between the dialysate regeneration unit and the dialyzer.

40. The blood based solute monitoring system of claim 1, wherein the dialysate regeneration unit is downstream of the dialyzer, further comprising an infusate injector wherein the infusate injector is positioned between the dialysate regeneration unit and the dialyzer.

41. The blood based solute monitoring system of claim 1, wherein the dialysate regeneration unit is downstream of the dialyzer, further comprising a buffer pump such that the buffer pump is positioned between the dialysate regeneration unit and the dialyzer.

42. The blood based solute monitoring system of claim 1, wherein the at least one sensor is a single sensor that selectively measures multiple sample streams of the fluid, and wherein at least one of the sample streams is substantially different in the concentration from the others.

43. The blood based solute monitoring system of claim 42, wherein the multiple sample streams include at least one sample stream from the fluid prior to passing through the dialysate regeneration unit and at least one sample stream from the fluid after passing through the dialysate regeneration unit.