Dialysis systems and methods

• US 8,580,112 B2
• Filed: 11/14/2008
• Issued: 11/12/2013
• Est. Priority Date: 11/16/2007
• Status: Active Grant

• Current Assignee: Fresenius Medical Care Holdings Incorporated (Fresenius Medical Care AG)
• Original Assignee: Fresenius Medical Care Holdings Incorporated (Fresenius Medical Care AG)
• Inventors: Updyke, Palmer David, Sandford, Harold Frederick, Lipps, Benjamin Joseph, Zatezalo, Douglas Mark, Beiriger, Michael James, Mullner, James Matthew
• Primary Examiner(s): Menon, Krishnan S
• Application Number:
  US12/271,359
• Publication Number:
  US 20090127193A1
• Time in Patent Office: 1,824 Days
• Field of Search: None
• US Class Current: 210/321.71
• 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 1/288 Priming priming in extracorporeal blood circuits A61M1/3643
• CPC Class Codes: A61M 1/3472 with treatment of the filtrate
• CPC Class Codes: A61M 2209/082 Mounting brackets, arm supports for equipment

Abstract

This disclosure generally relates to dialysis systems and related methods. In one aspect of the invention, a dialysis system includes a device configured so that a medical fluid can pass therethrough, and the device is adapted to remove one or more substances from the medical fluid as the medical fluid passes through the device. The dialysis system can also include a sodium control system adapted to alter a sodium concentration of the medical fluid.

Claims

1. A dialysis system, comprising:

a dialysis machine; and

a module that is directly, fluidly coupled to the dialysis machine via a fluid inlet line and a fluid outlet line such that dialysis solution flows directly from the module to the dialysis machine, through the dialysis machine, and directly from the dialysis machine back to the module, the module being electrically coupled to the dialysis machine and fluidly coupled to a dialysis solution reservoir, the module retaining a device in a manner such that dialysis solution can pass through the device, the device being adapted to remove one or more substances from the dialysis solution as the dialysis solution passes through the device, the module comprising

a fluid line connected to the device, the fluid line being arranged so that dialysis solution exiting the device passes through the fluid line, and

a sodium control system in fluid communication with the fluid line, the sodium control system being adapted to alter a sodium concentration of dialysis solution passing through the fluid line,

wherein the dialysis system controls a flow rate of dialysis solution from the module to the dialysis machine in a manner such that dialysis solution is diverted to the dialysis solution reservoir if an actual flow rate of dialysis solution from the module to the dialysis machine is greater than a desired flow rate and dialysis solution is drawn from the dialysis solution reservoir if the actual flow rate of dialysis solution from the module to the dialysis machine is less than the desired flow rate.

2. The dialysis system of claim 1, wherein the sodium control system is adapted to introduce a diluent into the fluid line.

3. The dialysis system of claim 2, wherein the diluent comprises water.

4. The dialysis system of claim 2, wherein the sodium control system comprises a container that contains the diluent, and the sodium control system further comprises a pump arranged to move the diluent from the container to the fluid line.

5. The dialysis system of claim 1, wherein the sodium control system is adapted to introduce sodium into the fluid line.

6. The dialysis system of claim 5, wherein the sodium is in the form of a sodium chloride solution.

7. The dialysis system of claim 5, wherein the sodium control system comprises a container that contains a sodium solution, and the sodium control system is adapted to draw the sodium solution from the container to the fluid line using vacuum.

8. The dialysis system of claim 5, wherein the sodium control system comprises a container that contains a sodium solution, and the sodium control system further comprises a pump arranged to move the sodium solution from the container to the fluid line.

9. The dialysis system of claim 8, wherein the sodium control system further comprises a diluent source, and the pump is arranged to move diluent from the diluent source to the fluid line.

10. The dialysis system of claim 9, wherein the diluent source is a fluid line that contains pressurized diluent.

11. The dialysis system of claim 9, wherein the sodium control system further comprises one or more valves that can be actuated to control movement of the sodium solution and the diluent to the fluid line.

12. The dialysis system of claim 1, further comprising a conductivity meter that is adapted to measure conductivity of the solution passing through the fluid line, the conductivity meter being in communication with the sodium control system.

13. The dialysis system of claim 12, wherein the sodium control system is adapted to alter the sodium concentration of the solution passing through the fluid line based on an output signal of the conductivity meter.

14. The dialysis system of claim 1, wherein the device is a sorbent cartridge.

15. The dialysis system of claim 14, wherein the sorbent cartridge comprises at least one layer of material capable of regenerating spent dialysis solution.

16. The dialysis system of claim 15, wherein a layer of the sorbent cartridge comprises sodium zirconium carbonate.

17. The dialysis system of claim 1, wherein the dialysis solution reservoir is a dual compartment reservoir.

18. The dialysis system of claim 17, wherein the dual compartment reservoir comprises a first reservoir for spent dialysis solution and a second reservoir for fresh dialysis solution.

19. The dialysis system of claim 18, further comprising an input line and an output line, the input and output lines being in fluid communication with the second reservoir, the input line being arranged to deliver fresh dialysis solution into the second reservoir and the output line being arranged to remove fresh dialysis solution from the second reservoir.

20. The dialysis system of claim 18, further comprising an input/output line, the input/output line being in fluid communication with the second reservoir, the input/output line being arranged to deliver fresh dialysis solution into the second reservoir and to remove fresh dialysis solution from the second reservoir.

21. The dialysis system of claim 1, further comprising an infusate system in fluid communication with the fluid line, the infusate system being adapted to introduce an infusate solution into the fluid line.

22. The dialysis system of claim 21, wherein the infusate solution comprises magnesium, calcium, and potassium.

23. The dialysis system of claim 21, further comprising a flow meter arranged to detect a flow rate of the dialysis solution, the infusate system being adapted to introduce the infusate solution into the fluid line based on the flow rate of the dialysis solution.

24. The dialysis system of claim 1, wherein the device is fluidly coupled to the module.

25. The dialysis system of claim 24, wherein the module comprises a device holder that can be arranged in a first configuration to allow fluid to pass through the device or in a second configuration to allow fluid to pass from a first portion of the device holder to a second portion of the device holder without passing through the device.

36. The dialysis system of claim 1, wherein the module is releasably, directly, fluidly and electrically coupled to the dialysis machine.

37. The dialysis system of claim 18, wherein the first and second reservoirs are configured so that fresh dialysis solution overflows from the second reservoir into the first reservoir when the second reservoir is filled beyond its capacity with the fresh dialysis solution.

43. The dialysis system of claim 1, wherein the dialysis system further comprises a T-valve that is fluidly coupled to the fluid line and is arranged so that dialysis solution is diverted from the fluid line to the dialysis solution reservoir if the actual flow rate of the dialysis solution from the module to the dialysis machine is greater than the desired flow rate and so that dialysis solution is drawn from the dialysis solution reservoir if the actual flow rate of the dialysis solution from the module to the dialysis machine is less than the desired flow rate.

45. The dialysis system of claim 1, wherein the sodium control system is spaced apart from the dialysis solution reservoir and from the device.

26. A dialysis apparatus, comprising:

a module that is releasably, directly, fluidly coupled to a dialysis machine via a fluid inlet line and a fluid outlet line such that dialysis solution flows directly from the module to the dialysis machine, through the dialysis machine, and directly from the dialysis machine back to the module, the module being electrically coupled to the dialysis machine and fluidly coupled to a dialysis solution reservoir, the module retaining a device adapted to remove one or more substances from a dialysis solution as the dialysis solution passes through the device after exiting the dialysis machine,

wherein the dialysis apparatus controls a flow rate of dialysis solution from the module to the dialysis machine in a manner such that dialysis solution is diverted to the dialysis solution reservoir if an actual flow rate of dialysis solution from the module to the dialysis machine is greater than a desired flow rate and dialysis solution is drawn from the dialysis solution reservoir if the actual flow rate of dialysis solution from the module to the dialysis machine is less than the desired flow rate.

27. The dialysis apparatus of claim 26, wherein the dialysis machine is a hemodialysis machine.

28. The dialysis apparatus of claim 26, wherein the device is a sorbent cartridge.

29. The dialysis apparatus of claim 26, wherein the module further comprises a sodium control system that is adapted to alter a sodium concentration of the dialysis solution.

30. The dialysis apparatus of claim 29, wherein the sodium control system is arranged to alter the sodium concentration of the dialysis solution after the dialysis solution passes through the device.

31. The dialysis apparatus of claim 26, wherein the module further comprises an infusate system that is adapted to introduce an infusate solution into the dialysis solution.

32. The dialysis apparatus of claim 31, wherein the infusate solution comprises magnesium, calcium, and potassium.

33. The dialysis apparatus of claim 31, wherein the infusate system is arranged to introduce the infusate solution into the dialysis solution after the dialysis solution passes through the device.

34. The dialysis apparatus of claim 26, wherein the module comprises a pump adapted to move the dialysis solution from the module to the dialysis machine when the module is fluidly coupled to the dialysis machine.

35. The dialysis apparatus of claim 26, wherein the module is releasably, directly, fluidly and electrically coupled to any of a plurality of different dialysis machines.

38. The dialysis apparatus of claim 26, wherein the dialysis solution reservoir is a dual compartment reservoir.

39. The dialysis apparatus of claim 38, wherein the dual compartment reservoir comprises a first reservoir for spent dialysis solution and a second reservoir for fresh dialysis solution.

40. The dialysis apparatus of claim 39, further comprising an input line and an output line, the input and output lines being in fluid communication with the second reservoir, the input line being arranged to deliver fresh dialysis solution into the second reservoir and the output line being arranged to remove fresh dialysis solution from the second reservoir.

41. The dialysis apparatus of claim 39, further comprising an input/output line, the input/output line being in fluid communication with the second reservoir, the input/output line being arranged to deliver fresh dialysis solution into the second reservoir and to remove fresh dialysis solution from the second reservoir.

42. The dialysis apparatus of claim 39, wherein the first and second reservoirs are configured so that fresh dialysis solution overflows from the second reservoir into the first reservoir when the second reservoir is filled beyond its capacity with the fresh dialysis solution.

44. The dialysis apparatus of claim 26, wherein the dialysis apparatus further comprises a T-valve that is fluidly coupled to the fluid line and is arranged so that dialysis solution is diverted from the fluid line to the dialysis solution reservoir if the actual flow rate of the dialysis solution from the module to the dialysis machine is greater than the desired flow rate and so that dialysis solution is drawn from the dialysis solution reservoir if the actual flow rate of the dialysis solution from the module to the dialysis machine is less than the desired flow rate.

46. The dialysis apparatus of claim 29, wherein the sodium control system is spaced apart from the dialysis solution reservoir and from the device.