Sodium and buffer source cartridges for use in a modular controlled compliant flow path

• US 9,526,822 B2
• Filed: 02/01/2013
• Issued: 12/27/2016
• Est. Priority Date: 02/01/2013
• Status: Active Grant

• Current Assignee: Mozarc Medical US LLC
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Meyer, Thomas E., Lura, David B., Pudil, Bryant J., Gerber, Martin T.
• Primary Examiner(s): BASS, DIRK R
• Application Number:
  US13/757,722
• Publication Number:
  US 20140217030A1
• Time in Patent Office: 1,425 Days
• Field of Search: 210/137, 210/143, 210/646, 210/647
• US Class Current: 1/1
• CPC Class Codes: A61M 1/1524 the interface providing means for actuating on functional elements of the cassette, e.g. plungers
• CPC Class Codes: A61M 1/154 with sensing means or components thereof
• CPC Class Codes: A61M 1/1562 Details of incorporated reservoirs
• CPC Class Codes: A61M 1/15632 the filter being a dialyser
• CPC Class Codes: A61M 1/16 with membranes
• CPC Class Codes: A61M 1/1605 Physical characteristics of the dialysate fluid
• CPC Class Codes: A61M 1/165 with a dialyser bypass on the dialysis fluid line
• CPC Class Codes: A61M 1/1658 Degasification
• CPC Class Codes: A61M 1/1666 by dissolving solids
• CPC Class Codes: A61M 1/3609 Physical characteristics of the blood, e.g. haematocrit, urea
• CPC Class Codes: A61M 1/3621 Extra-corporeal blood circuits single-needle circuits A61M1/30
• CPC Class Codes: A61M 1/3627 Degassing devices; Buffer reservoirs; Drip chambers; Blood filters
• 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: A61M 2205/3368 Temperature
• CPC Class Codes: A61M 2205/50 with microprocessors or computers
• CPC Class Codes: A61M 2205/502 User interfaces, e.g. screens or keyboards
• CPC Class Codes: A61M 2205/505 Touch-screens; Virtual keyboard or keypads; Virtual buttons; Soft keys; Mouse touches
• CPC Class Codes: A61M 2230/65 Impedance, e.g. conductivity, capacity

Abstract

Systems and methods for using a sodium chloride source and a buffer source such as sodium bicarbonate in a controlled compliant flow path to generate from water a physiologically compatible fluid having a suitable level of a sodium ion and/or a buffer for use in hemodialysis, hemodiafiltration and hemofiltration. The system has a conditioning flow path that has at least a salination valve or salination pump, and at least one container has at least one solute in excess of the solubility of that solute. At least one of the solutes is a buffer source or sodium chloride. The conditioning flow path is in fluid communication with a controlled compliant flow path. The conditioning flow path can selectively meter fluid into and out of the controlled compliant flow path.

Claims

1. A system for generating a physiologically compatible fluid, comprising:

a conditioning flow path having at least a salination valve, and at least one salination pump, and at least one container having at least one solute in excess of the solubility of that solute wherein at least one of the solutes is a buffer source or sodium chloride;

said conditioning flow path in fluid communication with a controlled compliant flow path connected to a dialyzer inlet and a dialyzer outlet and comprising a sorbent cartridge, wherein the conditioning flow path can selectively meter fluid into and out of the controlled compliant flow path, wherein fluid enters the conditioning flow path from the controlled compliant flow path through a conditioning flow path inlet; and

exits the conditioning flow path to the controlled compliant flow path through a conditioning flow path outlet; and

wherein the conditioning flow path inlet is positioned in the controlled compliant flow path downstream from the conditioning flow path outlet.

2. The system of claim 1, further comprising an extracorporeal flow path fluidly connected to the dialyzer, wherein the controlled compliant flow path modifies water into any one of a solution for priming an extracorporeal circuit, rinsing or flushing the dialyzer and blood flow conduits, a physiologically compatible solution for contacting blood, a physiologically compatible solution for bolus infusion to a subject, and a solution for blood rinse back to a subject.

3. The system of claim 1, wherein selectively metering in and metering out fluid from the controlled compliant flow path generates a physiologically compatible level of a sodium ion and/or a buffer from the at least one container in the conditioning flow path.

4. The system of claim 1, further comprising a sodium chloride container and a buffer source container.

5. The system of claim 4, wherein the conduits and containers of the conditioning flow path are controlled compliant.

6. The system of claim 4, wherein the sodium chloride and the buffer source are dry compositions, the dry compositions being hydrated by circulating a fluid through the conditioning flow path.

7. The system of claim 1, wherein a means for selectively metering fluid into and out of the controlled compliant flow path is a fluid balance control pump in fluid communication with the controlled compliant flow path and a fluid reservoir.

8. The system of claim 7, wherein a means for selectively metering fluid into and out of the controlled compliant flow path is any one of a control pump, a water pump, a salination pump, an acid concentrate pump, a replacement fluid pump, and combinations thereof.

9. The system of claim 1, wherein the controlled compliant flow path has at least one pump or valve in fluid communication with both a conduit of the controlled compliant flow path and a container;

and

a pump in fluid communication with a conduit of the controlled compliant flow path and a water source.

10. The system of claim 4, further comprising at least one pump or valve in fluid communication with a conduit of the controlled compliant flow path and at least a buffer source or a sodium source, a pump in fluid communication with a conduit of the controlled compliant flow path and a water source.

11. The system of claim 4, wherein fluid passing through the sodium chloride container increases the sodium chloride concentration of the fluid and fluid passing through the buffer source container increases the buffer concentration of the fluid.

12. The system of claim 4, wherein the sodium chloride container, the buffer source container and the salination valve are configured into a consumables cartridge.

13. The system of claim 4, wherein the sodium chloride and the buffer source are contained in separate compartments of a common container or cartridge.

14. The system of claim 13, wherein the sodium compartment and the buffer source compartment share a common fluid inlet port or a common fluid outlet port.

15. The system of claim 4, wherein a container is disposable.

16. The system of claim 4, wherein a container is re-usable and refilled or replenished with sodium chloride or a buffer source.

17. The system of claim 4, wherein a sodium chloride container or a buffer source container are configured together with any of an extracorporeal circuit, a dialyzer, a degassing module, a cation concentrate reservoir, a control reservoir, a sorbent container, a cleaning and/or disinfection concentrate, or an ammonia sensing module into a therapy cassette.

18. The system of claim 4, wherein the salination valve is located downstream from the sodium chloride container and the buffer source container and the salination pump is located upstream from the sodium chloride container and the buffer source container.

19. The system of claim 4, wherein the salination valve is located upstream from the sodium chloride container and the buffer source container and the salination pump is located downstream from the sodium chloride container and the buffer source container.

20. The system of claim 4, wherein fluid flow through the sodium chloride container and the buffer source container can occur concurrently.

21. The system of claim 4, wherein the controlled compliant flow path is fluidly connected to a source selected from the group consisting of a potable water source, a tap water source, a bottled water source, a purified water source and combinations thereof, a physiologically compatible solution source, a dialysate source, a filtrate source, or a replacement fluid source;

and wherein a portion of the fluid entering a container is water selected from any one of potable water, tap water, bottled water, purified water and combinations thereof, a physiologically compatible solution, a dialysate, a filtrate, or a replacement fluid.

22. The system of claim 4, further comprising a sorbent system, and wherein a portion of the fluid entering a container is water that has been purified through the sorbent system.

23. The system of claim 4, wherein the sodium chloride container contains a first dry composition and the buffer source container contains a second dry composition, the first and second dry compositions are hydrated during circulation of fluid through the conditioning flow path and the quantity of the dry compositions provided are in excess of the quantities required for operation wherein a portion of the dry compositions remains undissolved in the sodium chloride container and the buffer source container, the sodium chloride container and the buffer source container being operable such that a saturated solution exits the sodium chloride container and/or the buffer source container.

24. The system of claim 23, wherein a container has at least one fluid inlet port and at least one fluid outlet port, and filtering media at the inlet port and outlet port to prevent at least a portion of undissolved sodium chloride or undissolved buffer source from exiting the container.

25. The system of claim 4, wherein a consumables cartridge has a sodium chloride container, a buffer source container and a salination valve for controlling flow of fluid diverted from a conduit of the controlled compliant flow path through the sodium chloride container and the buffer source container.

26. The system of claim 4, wherein the salination valve controls the amount of a fluid flowing through the conditioning flow path into the sodium chloride container and the buffer source container before the fluid returns to the controlled compliant flow path.

27. The system of claim 4, wherein the salination valve directs a fluid through either the sodium chloride container, the sodium bicarbonate container, or both.

28. The system of claim 1, wherein a salination valve is a 2-way or a 3-way valve.

29. The system of claim 4, wherein either the sodium chloride container or the buffer source container is detachable from the conditioning flow path.

30. The system of claim 1, wherein the conditioning flow path is detachable from the controlled compliant flow path.

31. The system of claim 1, wherein the controlled compliant flow path further comprises a conductivity sensor and the system further comprises a controller to control the amount of fluid flow through a conditioning flow path, based at least in part on the conductivity of the fluid in the controlled compliant flow path.

32. The system of claim 1, wherein the conditioning flow path further comprises a temperature sensor, and the system further comprises a controller to control the rate of fluid flow through a conditioning flow path, based at least in part on the temperature of a fluid in the conditioning flow path.

33. The system of claim 1, further comprising

a common reservoir and a control pump in fluid communication with the conditioning flow path wherein the common reservoir contains any one of a dialysate, a filtrate, a volume of a physiologically compatible priming solution, a volume of a physiologically compatible solution to provide a bolus of fluid to a subject receiving treatment, a volume of physiologically compatible solution to provide solution for return of blood from an extracorporeal flow path to a subject receiving treatment, a volume of solution returned to the common reservoir from an extracorporeal flow path when blood from a subject is introduced to the extracorporeal flow path, and combinations thereof.

34. The system of claim 32, wherein a dialysate is produced by the system for performing hemodialysis or hemodiafiltration from water introduced to a conduit of the controlled compliant flow path, a sorbent system, the sodium chloride container, and optionally solutes other than sodium introduced to a conduit of the controlled compliant flow path.

35. The system of claim 32, wherein a volume of a physiologically compatible priming solution is produced by the system from water introduced to a conduit of the controlled compliant flow path, a sorbent system, the sodium chloride container, and optionally solutes other than sodium introduced to the conduit of the controlled compliant flow path.

36. The system of claim 32, wherein a volume of a physiologically compatible solution to provide a bolus of fluid to a subject receiving a blood dialysis, hemofiltration or fluid removal treatment is produced by the system from water introduced to a conduit of the controlled compliant flow path, a sorbent system and the sodium chloride container, and optionally solutes other than sodium introduced to a conduit of the controlled compliant flow path.

37. The system of claim 32, wherein the volume of a physiologically compatible solution to provide solution for return of blood from an extracorporeal flow path to a subject receiving a blood dialysis or fluid removal treatment is produced by the system from water introduced to a conduit of the controlled compliant flow path, a sorbent system and the sodium chloride container, and optionally solutes other than sodium introduced to the conduit of the controlled compliant flow path.

38. The system of claim 33, wherein the physiologically compatible priming solution delivered from the common reservoir to a conduit of the controlled compliant flow path is in fluid communication with an extracorporeal flow path for priming of the extracorporeal flow path wherein the priming solution is passed through a sorbent system and at least a microbial filter or a dialyzer membrane.

39. The system of claim 33, wherein a volume of solution is returned to the common reservoir from an extracorporeal flow path when blood from a subject is introduced to the extracorporeal flow path.

40. The system of claim 4, wherein the buffer source container contains bicarbonate.

41. The system of claim 4, wherein the salination valve is periodically switched to direct fluid flow through the buffer source container to infuse a desired amount of buffer into the fluid.

42. The system of claim 4, wherein a physiologically compatible solution is continually prepared by the system until a predetermined volume of solution has been produced and reserved in a solution reservoir.

43. The system of claim 1, further comprising a filter positioned downstream from the at least one container wherein the microbial filter removes undissolved particulates/aggregates and any contaminants contained in the at least one container.

44. A method for generating a physiologically compatible fluid, comprising the steps of:

preparing the physiologically compatible fluid from water using the system of claim 1 wherein the controlled compliant flow path modifies water into any one of a solution for priming a blood system, a solution for flushing or rinsing a dialyzer or an extracorporeal flow path, a physiologically compatible solution for contacting blood, a physiologically compatible solution for bolus infusion to a subject, and a solution for blood rinse back to a subject.

45. The method of claim 44, wherein the at least one container comprises a first container and a second container, wherein the first container is a sodium chloride cartridge and the second container is a buffer source cartridge, and generating a predetermined concentration of sodium ion and buffer from the sodium chloride cartridge and the buffer source cartridge.

46. The method of claim 45, further comprising the step of:

generating a physiologically compatible priming solution; and

storing the physiologically compatible priming solution in a therapy solution reservoir using a control pump on the controlled compliant flow path.

47. The method of claim 45, further comprising the step of:

generating a physiologically compatible bolus infusion solution; and

storing the physiologically compatible bolus infusion solution in a therapy solution reservoir using a control pump on the controlled compliant flow path.

48. The method of claim 45, further comprising the step of:

generating a physiologically compatible rinse-back solution; and

storing the physiologically compatible rinse-back solution in a therapy solution reservoir using a control pump on the controlled compliant flow path.

49. A method for generating a physiologically compatible fluid, comprising the steps of:

providing water to the system of claim 1, wherein the controlled compliant flow path is in fluid communication with an extracorporeal flow path across a semi-permeable membrane;

configuring the system to bypass the extracorporeal flow path, the system having a bypass conduit flow path for conveying fluid through a first segment of the controlled compliant flow path without contacting the semipermeable membrane;

conveying the water through the conditioning flow path;

reconstituting an electrolyte source to generate a physiologically compatible fluid, and conveying the fluid through the first segment of the controlled compliant flow path.

50. The method of claim 49 wherein the dissolved gas is removed from the water.

51. The method of claim 49 wherein the conditioning flow path has a buffer source cartridge.

52. The method of claim 51 wherein the buffer source cartridge is an interchangeable bicarbonate cartridge.

53. The method of claim 49, wherein the conditioning flow path has a sodium conduit flow path with a sodium source configured in parallel with a buffer source conduit flow path with a buffer source.

54. The method of claim 49, further comprising the steps of:

sensing fluid conductivity using a conductivity sensor; and

operating a water pump to add water to reduce a sodium level or, alternatively, controlling the salination valve on the conditioning flow path to direct flow through the sodium chloride container and operating the salination pump to infuse a sodium chloride concentrate into the fluid to increase a sodium level in the controlled compliant flow path.

55. The method of claim 49, wherein a pump rate of the salination pump is adjusted, at least in part, according to the conductivity readings to maintain a desired sodium chloride concentration in the controlled compliant flow path.

56. The method of claim 49, further comprising the step of sensing a temperature of the fluid in the conditioning flow path using a temperature sensor and wherein a pump rate of the salination pump is adjusted, at least in part, according to the temperature readings to achieve a desired rate of sodium or buffer infusion to the controlled compliant flow path.

57. The method of claim 49 further comprising determining the fluid flow rate in the controlled compliant flow path and adjusting the rate of the salination pump, at least in part, based on the fluid flow rate in the controlled compliant flow path.