Flow-through peritoneal dialysis systems and methods with on-line dialysis solution regeneration

• US 6,254,567 B1
• Filed: 02/23/2000
• Issued: 07/03/2001
• Est. Priority Date: 02/26/1999
• Status: Expired due to Fees

• Current Assignee: Nxstage Medical Incorporated (Fresenius SE & Co. KGaA)
• Original Assignee: Nxstage Medical Incorporated (Fresenius SE & Co. KGaA)
• Inventors: Brugger, James M., Treu, Dennis M., Burbank, Jeffrey H.
• Primary Examiner(s): MENDEZ, MANUEL A
• Application Number:
  US09/512,132
• Time in Patent Office: 496 Days
• Field of Search: 604/5.01, 604/4.01, 604/31, 604/27, 604/28, 604/29, 604/317, 604/322, 604/323, 604/326, 604/327, 604/328, 604/332, 604/335, 210/645-647
• US Class Current: 604/29
• 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 1/284 Continuous flow peritoneal dialysis [CFPD]
• CPC Class Codes: A61M 1/288 Priming priming in extracorporeal blood circuits A61M1/3643

Abstract

Peritoneal dialysis is performed by circulating peritoneal dialysis solution through a peritoneal cavity by conveying peritoneal dialysis solution through an inlet branch into the peritoneal cavity and by withdrawing peritoneal dialysis solution through an outlet branch from the peritoneal cavity. Peritoneal dialysis solution in the outlet branch is conveyed along a first side of a porous membrane while conveying a regeneration solution containing at least one regenerating agent along a second side of the porous membrane. The membrane is configured to transport the regenerating agent into the peritoneal dialysis solution while transporting waste from the peritoneal dialysis solution into the regeneration solution, thereby creating a regenerated peritoneal dialysis solution. The regenerated peritoneal dialysis solution is circulated through the inlet branch into the peritoneal cavity.

Claims

1. A system for conducting peritoneal dialysis comprising

a pumping assembly to circulate peritoneal dialysis solution through a peritoneal cavity to perform peritoneal dialysis including a inlet branch to convey peritoneal dialysis solution into the peritoneal cavity and an outlet branch to withdraw peritoneal dialysis solution from the peritoneal cavity, and

a regeneration assembly coupled in-line between the inlet and outlet branches, the regeneration assembly including a source of a regeneration solution that carries at least one agent for regenerating spent peritoneal dialysis solution, and a porous membrane having a first side, along which peritoneal dialysis solution is circulated by the pumping assembly from the outlet branch to the inlet branch, and a second side, along which the regeneration solution is circulated, the porous membrane being configured to transport waste from spent peritoneal dialysis solution into the regeneration solution and to transport the regenerating agent from the regeneration solution into spent peritoneal dialysis solution, the regeneration assembly operating to create from peritoneal dialysis solution in the outlet branch, a regenerated dialysis solution for conveyance through the inlet branch into the peritoneal cavity.

2. A system according to claim 1

wherein the regeneration assembly includes a pump to convey regeneration solution from the source along the second side of the porous membrane.

3. A system according to claim 1

wherein the regeneration assembly includes a waste line to remove regeneration solution from the second side of the porous membrane.

4. A system according to claim 3

wherein the waste line communicates with a drain.

5. A system according to claim 3

wherein the waste line communicates with a waste-receiving container.

6. A system according to claim 3

wherein the waste line communicates with the source of regeneration solution to recirculate at least a portion of the regeneration solution.

7. A system according to claim 1

wherein the regenerating agent includes an electrolyte.

8. A system according to claim 1

wherein the regenerating agent includes a buffering agent.

9. A system according to claim 8

wherein the buffering agent comprises a bicarbonate buffering material.

10. A system according to claim 8

wherein the buffering agent comprises a lactate buffering agent.

11. A system according to claim 1

wherein the regenerating agent includes an electrolyte and a buffering agent.

12. A system according to claim 11

wherein the buffering agent comprises a bicarbonate buffering material.

13. A system according to claim 11

wherein the buffering agent comprises a lactate buffering agent.

14. A system according to claim 1

wherein the source of regeneration solution draws water from a source of water.

15. A system according to claim 14

wherein the source of water comprises tap water.

16. A system according to claim 14

wherein the source of regeneration solution includes a device to treat water drawn from the source of water.

17. A system according to claim 14

wherein the source of regeneration solution includes a device to mix the at least one regenerating agent with water drawn from the source of water.

18. A system according to claim 1

wherein the source of regeneration solution draws water from a source of running water.

19. A system according to claim 18

wherein the source of running water is tap water.

20. A system according to claim 18

wherein the source of regeneration solution includes a device to treat water drawn from the source of the running water.

21. A system according to claim 18

wherein the source of regeneration solution includes a device to mix the at least one regenerating agent with water drawn from the source of running water.

22. A system according to claim 1

wherein the source of regeneration solution includes a container holding a volume of water in which the at least one regenerating agent is mixed.

23. A system according to claim 1

wherein the source of regeneration solution includes a first container holding a volume of water and a second container that holds the at least one regenerating agent, the second container being located within the first container and including a wall material that, when contacted by water, transports the at least one regenerating agent into the water, thereby forming the regeneration solution.

24. A system according to claim 1

wherein the regeneration assembly includes a device to heat the regeneration solution before circulation along the second side of the porous membrane.

25. A system according to claim 1

wherein the regeneration assembly includes a sterilizing filter between the source of regeneration solution and the porous membrane.

26. A system according to claim 1

wherein the porous membrane comprises a semipermeable membrane.

27. A system according to claim 26

wherein the porous membrane comprises a bundle of hollow fibers each having an exterior, which comprises the second side of the porous membrane, and an interior lumen, which comprises the first side of the porous membrane.

28. A system according to claim 1

wherein the porous membrane transports waste and the at least one regenerating agent by diffusion, convection, or both.

29. A system according to claim 1

wherein the inlet branch communicates with a first access device providing access to the peritoneal cavity, and

wherein the outlet branch communicates a second access device providing access to the peritoneal cavity independent of the access provided by the first device.

30. A system according to claim 29

wherein the pumping assembly includes a controller that withdraws peritoneal dialysis solution through the second access device into the regeneration assembly while conveying regenerated peritoneal dialysis solution from the regeneration device into the peritoneal cavity through the first access device.

31. A system according to claim 29

wherein at least one of the first and second access devices comprises a subcutaneous access port.

32. A system according to claim 1

wherein the inlet and outlet branches jointly communicate with a single access device that provides common access to the peritoneal cavity.

33. A system according to claim 32

wherein the pumping assembly includes a controller operating in a draw mode, to withdraw peritoneal dialysis solution from the peritoneal cavity through the single access device into the regeneration assembly, and a return mode, to convey regenerated peritoneal dialysis solution into the peritoneal cavity through the single access device.

34. A system according to claim 33

wherein the controller toggles between the draw mode and the return mode.

35. A system according to claim 33

wherein the regeneration assembly includes a reservoir in the inlet branch to collect regenerated peritoneal dialysis solution during the draw mode.

36. A system according to claim 35

wherein the regeneration assembly includes a sensor to sense presence of regenerated dialysis solution in the reservoir and to generate an output relating to volume of regenerated peritoneal dialysis solution present in the reservoir, and

wherein the controller toggles between the draw mode and return mode in response to the output.

37. A system according to claim 32

wherein the single access device comprises a subcutaneous access port.

38. A system according to claim 1

wherein the regeneration assembly includes a fluid balancing module to maintain a volumetric balance between waste and regenerating agent transported by the porous membrane.

39. A system according to claim 1

wherein the regeneration assembly includes an ultrafiltration module to selectively transport a preselected greater volume of waste than regenerating agent.

40. A system according to claim 1

wherein the pumping assembly accommodates circulation of a cleaning or disinfecting agent through the inlet and outlet branches, bypassing the peritoneal cavity.

41. A system according to claim 1

wherein the regeneration assembly accommodates circulation of a cleaning or disinfecting agent along the first and second sides of the porous membrane.

42. A method for conducting peritoneal dialysis comprising steps of

(i) circulating peritoneal dialysis solution through a peritoneal cavity to perform peritoneal dialysis by conveying peritoneal dialysis solution through an inlet branch into the peritoneal cavity and by withdrawing peritoneal dialysis solution through an outlet branch from the peritoneal cavity,

(ii) during at least a portion of step (i), conveying peritoneal dialysis solution in the outlet branch along a first side of a porous membrane while conveying a regeneration solution containing at least one regenerating agent along a second side of the porous membrane, the membrane being configured to transport the regenerating agent into the peritoneal dialysis solution while transporting waste from the peritoneal dialysis solution into the regeneration solution, thereby creating a regenerated peritoneal dialysis solution, and

(iii) during at least a portion of step (i), circulating the regenerated peritoneal dialysis solution through the inlet branch into the peritoneal cavity.

43. A method according to claim 42

wherein steps (ii), and (iii) are performed simultaneously.

44. A method according to claim 42

wherein steps (ii) and (iii) are performed sequentially.

45. A method according to claim 42

wherein, during step (ii), a prescribed volumetric balance is maintained between waste and regenerating agent transported by the porous membrane to achieve fluid balancing.

46. A method according to claim 42

wherein, during step (ii), a preselected greater volume of waste than regenerating agent is selectively transported by the porous membrane to achieve ultrafiltration.

47. A method according to claim 42

wherein, during step (ii), regeneration solution is removed from the second side of the porous membrane to a waste line.

48. A method according to claim 42

wherein, during step (ii), water is drawn from a source of water to create the regeneration solution.

49. A method according to claim 48

wherein the source of water is tap water.

50. A method according to claim 48

wherein, during step (ii), water that is drawn from the source of water is treated.

51. A method according to claim 48

wherein, during step (ii), the at least one regenerating agent is mixed with water drawn from the source of water.

52. A method according to claim 48

wherein, during step (ii), water is drawn from a source of running water to create the regeneration solution.

53. A method according to claim 52

wherein the source of running water is tap water.

54. A method according to claim 52

wherein, during step (ii), water that is drawn from the source of running water is treated.

55. A method according to claim 52

wherein, during step (ii), the at least one regenerating agent is mixed with water drawn from the source of running water.

56. A method according to claim 42

wherein, during step (ii), the regeneration solution is heated before circulation along the second side of the porous membrane.

57. A method according to claim 42

wherein, during step (ii), the regeneration solution is passed through a sterilizing filter before circulation along the second side of the porous membrane.

58. A method according to claim 42

wherein, after completion of step (i), a cleaning or disinfecting agent is circulated through the inlet and outlet branches, bypassing the peritoneal cavity.

59. A method according to claim 42

wherein, after completion of step (i), a cleaning or disinfecting agent is circulated along the first and second sides of the porous membrane.