Peritoneal dialysis systems and methods that regenerate dialysate

• US 8,815,095 B2
• Filed: 09/18/2009
• Issued: 08/26/2014
• Est. Priority Date: 07/19/2002
• Status: Active Grant

• Current Assignee: Baxter Healthcare SA (Baxter International Inc.), Baxter International Inc.
• Original Assignee: Baxter Healthcare SA (Baxter International Inc.), Baxter International Inc.
• Inventors: Micheli, Brian R.
• Primary Examiner(s): DRODGE, JOSEPH W
• Application Number:
  US12/562,737
• Publication Number:
  US 20100010430A1
• Time in Patent Office: 1,803 Days
• Field of Search: 210/87, 210/97, 210/110, 210/137, 210/143, 210/194, 210/195.1, 210/195.2, 210/257.1, 210/257.2, 210/258, 210/259, 210/321.65, 210/321.71, 210/637, 210645-647, 210/651, 210/663, 210/669, 210/805, 210/806, 604/4.01, 604/5.01, 604/5.04, 604/6.09, 604/6.11, 604/29, 604/30, 604/65, 604/67
• US Class Current: 210/637
• CPC Class Codes: A61M 1/166 Heating for sterilisation A61M1/1686
• 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 2202/0021 removed from and reintroduced into the body, e.g. after treatment

Abstract

An artificial kidney that regenerates dialysate includes: a catheter having an inflow lumen and an outflow lumen for communication with a peritoneal cavity of a patient; a fluid circuit in fluid communication with the catheter for circulating dialysate into, through and out of the peritoneal cavity; a pump configured to circulate the dialysate; a cleaning cartridge coupled to the fluid circuit for removing solutes from the dialysate, including a therapeutically effective amount of urea from the dialysate as the dialysate circulates along the fluid circuit; and wherein the fluid circuit is configured to receive a volume of ultrafilterate removed from the patient, such that the pump can mix the ultrafiltrate volume with the dialysate to an increase an overall therapy fluid volume.

Claims

1. A system for providing peritoneal dialysis that regenerates therapy fluid, the system comprising:

a catheter having an inflow lumen and an outflow lumen for communication with a peritoneal cavity of a patient;

a single fluid circuit in fluid communication with the catheter for circulating fluid into, through and out of the peritoneal cavity;

a single supply container of therapy fluid coupled via a single two-way line to the fluid circuit, the therapy fluid configured to remove a plurality of solutes from the peritoneal cavity of the patient, and the supply container being part of the fluid circuit during therapy and configured to accommodate an increased fluid volume used for therapy;

a single supply of an osmotic agent solution coupled to the fluid circuit for replenishing the therapy fluid;

a disposable cleaning cartridge coupled to the fluid circuit, wherein the cleaning cartridge removes an amount of solutes from the therapy fluid returning from the patient; and

a controller programmed to provide an effective peritoneal dialysis therapy via the single fluid circuit using a combination of (i) the single supply of therapy fluid, (ii) the single supply of the osmotic agent solution replenishing the therapy fluid, (iii) the disposable cleaning cartridge removing solutes from the therapy fluid, (vi) circulating fluid through the fluid circuit at a first flow rate, and (v) circulating the increased fluid volume into the single supply container along the single two-way line at a second flow rate, the first flow rate being higher than the second flow rate.

2. The system of claim 1, which is configured to circulate dialysate through the fluid circuit at a flow rate of less than 100 ml/minute.

3. The system of claim 1, which is configured to circulate dialysate into, through, and out of the peritoneal cavity of the patient, the cartridge removing a therapeutically effective amount of solutes from the dialysate exiting the patient.

4. The system of claim 1, further comprising a flow volume sensing device operably coupled to the single fluid circuit.

5. The system of claim 1, wherein the cleaning cartridge includes at least one of:

a sorbent material;

a filter to retain at least one of proteins and particulates; and

a source of electrolytes to replenish the dialysate as it is circulated.

6. The system of claim 1, wherein the cleaning cartridge includes at least one sorbent material, including at least one of:

carbon, activated charcoal and urease.

7. The system of claim 1, wherein the osmotic agent solution includes dextrose.

8. The system of claim 1, which includes a pump configured to circulate the therapy fluid.

9. The system of claim 1, which includes a pump coupling the single two-way line to the fluid circuit, the controller programmed to operate the pump to circulate the therapy fluid through the fluid circuit and into and out of the single supply container.

10. The system of claim 1, wherein the controller is programmed to feed (i) a portion of the therapy fluid from the single supply container into the fluid circuit during a first treatment cycle, and (ii) a remaining portion of the therapy fluid from the single supply container into the fluid circuit during a second treatment cycle, and wherein the controller is programmed to circulate the entire volume of therapy fluid through the fluid circuit until treatment is complete once the remaining portion has been fed into the fluid circuit.

11. The system of claim 1, wherein the controller is programmed to keep a volume capacity of the fluid circuit constant during treatment by discharging therapy fluid from the fluid circuit into the single supply container at a rate approximate to an infusion of therapy fluid and transport of ultrafiltrate into the fluid circuit.

12. An artificial kidney that regenerates dialysate, the artificial kidney comprising:

a supply of dialysate;

a catheter having an inflow lumen and an outflow lumen for communication with a peritoneal cavity of a patient;

a fluid circuit in fluid communication with the catheter for circulating dialysate from the supply, into, through and out of the peritoneal cavity;

a pump configured to circulate the dialysate;

a cleaning cartridge coupled to the fluid circuit for removing solutes from the dialysate as the dialysate circulates within the fluid circuit; and

a controller programmed to (i) operate the pump so as to pump a volume of ultrafiltrate removed from the patient, and mix the ultrafiltrate volume with the dialysate from the supply to increase an overall therapy fluid volume, and wherein the supply of dialysate (a) holds less than six liters of original dialysate and (b) is sized to accommodate and accordingly store the increase in overall therapy fluid volume, such that a therapeutically effective amount of solutes can be removed from the patient, and (ii) circulate dialysate through the fluid circuit at a first flow rate and circulate dialysate into and out of the supply of dialysate at a second flow rate, the first flow rate being higher than the second flow rate.

13. The artificial kidney of claim 12, wherein the cleaning cartridge is disposable and includes at least one of:

a sorbent material and a filter for removing particles at least 0.22 microns in size.

14. The artificial kidney of claim 12, wherein the pump is configured to circulate the dialysate continuously or intermittently.

15. The artificial kidney of claim 12, further comprising at least one heater for warming the dialysate.

16. The artificial kidney of claim 12, wherein the cleaning cartridge includes at least one of carbon, activated charcoal and urease.

17. The artificial kidney of claim 12, wherein the cleaning cartridge is configured for selectively or non-selectively removing solutes from the dialysate.

18. The system according to claim 12, which includes a supply of an osmotic agent solution coupled to the fluid circuit for replenishing the dialysate, such that the supply can hold less than six liters of dialysate and the therapeutically effective amount of solutes can be removed from the patient.

19. The system according to claim 12, wherein the cleaning cartridge includes at least one organic polymer for binding at least one solute from the dialysate.

20. The system of claim 12, wherein the supply of dialysate is coupled to the fluid circuit via the pump, the controller programmed to operate the pump to circulate dialysate through the fluid circuit and into and out of the supply of dialysate.

21. The system of claim 12, wherein the controller is programmed to feed (i) a portion of the dialysate from the supply of dialysate into the fluid circuit during a first treatment cycle, and (ii) a remaining portion of the dialysate from the supply of dialysate into the fluid circuit during a second treatment cycle, and wherein the controller is programmed to circulate the entire volume of dialysate through the fluid circuit until treatment is complete once the remaining portion has been fed into the fluid circuit.

22. The system of claim 12, wherein the controller is programmed to keep a volume capacity of the fluid circuit constant during treatment by discharging dialysate from the fluid circuit into the supply of dialysate at a rate approximate to an infusion of dialysate and transport of ultrafiltrate into the fluid circuit.

23. A method for providing peritoneal dialysis that regenerates dialysate, the method comprising:

providing a supply of dialysate along a fluid circuit;

circulating less than six liters of original dialysate at a first flow rate from the supply through the fluid circuit into, through, and out of a peritoneal cavity of a patient via a catheter having an inflow lumen and an outflow lumen in communication with the fluid circuit to provide continuous flow peritoneal dialysis to the patient;

circulating dialysate into and out of the supply of dialysate at a second flow rate, the first flow rate being higher than the second flow rate;

removing a therapeutically effective amount of solutes and ultrafiltrate from the patient using the less than six liters of dialysate;

removing at least most of the solutes from the dialysate via a cartridge coupled to the fluid circuit, the cartridge including a sorbent material and a binder material for the non-enzymatic removal of the solutes, the non-enzymatic cartridge being the only solute removing means employed by the method; and

storing the ultrafiltrate removed from the patient along with used dialysate in the supply of dialysate.

24. The method according to claim 23, wherein the step of removing the at least most of the solutes includes (i) removing at least a portion of the urea from the dialysate, and (ii) removing at least most of one of the solutes using at least one of carbon, and activated charcoal.

25. The method according to claim 24, which includes adding an osmotic agent solution to the dialysate to replenish the dialysate.

26. The method according to claim 24, which includes mixing an ultrafiltrate volume removed from the patient with the dialysate to increase an overall therapy fluid volume.

27. The method of claim 23, which includes coupling the supply of dialys ate to the fluid circuit via a pump, and operating the pump to circulate the dialys ate through the fluid circuit and into and out of the supply of dialysate.

28. The method of claim 23, which includes (i) feeding a portion of the dialysate from the supply of dialysate into the fluid circuit during a first treatment cycle, (ii) feeding a remaining portion of the dialysate from the supply of dialysate into the fluid circuit during a second treatment cycle, and (iii) circulating the entire volume of dialysate through the fluid circuit until treatment is complete once the remaining portion has been fed into the fluid circuit.

29. The method of claim 23, which includes maintaining a volume capacity of the fluid circuit during treatment by discharging dialysate from the fluid circuit into the supply of dialysate at a rate approximate to an infusion of dialysate and transport of ultrafiltrate into the fluid circuit.

30. A system for providing peritoneal dialysis that regenerates therapy fluid, the system comprising:

a catheter having an inflow lumen and an outflow lumen for communication with a peritoneal cavity of a patient;

a single fluid circuit in fluid communication with the catheter for circulating fluid into, through and out of the peritoneal cavity;

a single supply container of therapy fluid coupled via a single two-way line to the fluid circuit, the therapy fluid configured to remove a plurality of solutes from the peritoneal cavity of the patient, and the supply container being part of the fluid circuit during therapy and configured to accommodate an increased fluid volume used for therapy;

a single supply of an osmotic agent solution coupled to the fluid circuit for replenishing the therapy fluid;

a disposable cleaning cartridge coupled to the fluid circuit, wherein the cleaning cartridge removes an amount of solutes from the therapy fluid returning from the patient; and

a controller programmed to provide an effective peritoneal dialysis therapy via the single fluid circuit using a combination of (i) the single supply of therapy fluid, (ii) the single supply of the osmotic agent solution replenishing the therapy fluid, (iii) the disposable cleaning cartridge removing solutes from the therapy fluid, and (iv) circulating the increased fluid volume into the single supply container,

wherein the controller is also programmed to feed (a) a portion of the therapy fluid from the single supply container into the fluid circuit during a first treatment cycle, and (b) a remaining portion of the therapy fluid from the single supply container into the fluid circuit during a second treatment cycle, and

wherein the controller is further programmed to circulate the entire volume of therapy fluid through the fluid circuit until treatment is complete once the remaining portion has been fed into the fluid circuit.

31. An artificial kidney that regenerates dialysate, the artificial kidney comprising:

a supply of dialysate;

a catheter having an inflow lumen and an outflow lumen for communication with a peritoneal cavity of a patient;

a fluid circuit in fluid communication with the catheter for circulating dialysate from the supply, into, through and out of the peritoneal cavity;

a pump configured to circulate the dialysate;

a cleaning cartridge coupled to the fluid circuit for removing solutes from the dialysate as the dialysate circulates within the fluid circuit; and

a controller programmed to operate the pump so as to pump a volume of ultrafiltrate removed from the patient, and mix the ultrafiltrate volume with the dialys ate from the supply to increase an overall therapy fluid volume, and wherein the supply of dialysate (a) holds less than six liters of original dialysate and (b) is sized to accommodate and accordingly store the increase in overall therapy fluid volume, such that a therapeutically effective amount of solutes can be removed from the patient,

wherein the controller is also programmed to feed (i) a portion of the dialysate from the supply of dialysate into the fluid circuit during a first treatment cycle, and (ii) a remaining portion of the dialysate from the supply of dialysate into the fluid circuit during a second treatment cycle, and

wherein the controller is further programmed to circulate the entire volume of dialysate through the fluid circuit until treatment is complete once the remaining portion has been fed into the fluid circuit.

32. A method for providing peritoneal dialysis that regenerates dialysate, the method comprising:

providing a supply of dialysate along a fluid circuit;

circulating less than six liters of original dialysate from the supply through the fluid circuit into, through, and out of a peritoneal cavity of a patient via a catheter having an inflow lumen and an outflow lumen in communication with the fluid circuit to provide continuous flow peritoneal dialysis to the patient, wherein the circulating includes (i) feeding a portion of the dialysate from the supply of dialysate into the fluid circuit during a first treatment cycle, (ii) feeding a remaining portion of the dialysate from the supply of dialysate into the fluid circuit during a second treatment cycle, and (iii) circulating the entire volume of dialysate through the fluid circuit until treatment is complete once the remaining portion has been fed into the fluid circuit;

removing a therapeutically effective amount of solutes and ultrafiltrate from the patient using the less than six liters of dialysate;

removing at least most of the solutes from the dialysate via a cartridge coupled to the fluid circuit, the cartridge including a sorbent material and a binder material for the non-enzymatic removal of the solutes, the non-enzymatic cartridge being the only solute removing means employed by the method; and

storing the ultrafiltrate removed from the patient along with used dialysate in the supply of dialysate.