Systems and methods for performing peritoneal dialysis

• US 7,867,214 B2
• Filed: 07/17/2003
• Issued: 01/11/2011
• Est. Priority Date: 07/19/2002
• Status: Active Grant

• Current Assignee: Baxter International Inc.
• Original Assignee: Baxter Healthcare SA (Baxter International Inc.), Baxter International Inc.
• Inventors: Brown, David S., Martis, Leo, Wariar, Ramesh, Karoor, Sujatha, Buchmann, Cody, Soltys, Paul, Childers, Robert W., Din, Shahid
• Primary Examiner(s): Zalukaeva; Tatyana
• Assistant Examiner(s): Chapman; Ginger T
• Application Number:
  US10/623,316
• Publication Number:
  US 20040019312A1
• Time in Patent Office: 2,735 Days
• Field of Search: 604/411, 604/403, 604404-410, 604/5.01, 604/6.06, 604/6.09, 604/4.01, 604/5.02, 422/44, 422/48, 210/648, 210/670, 210/644, 210/645, 210/646, 210/649, 210650-653
• US Class Current: 604/411
• 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 1/153 the cassette being adapted for heating or cooling the treating fluid, e.g. the dialysate or the treating gas
• CPC Class Codes: A61M 1/154 with sensing means or components thereof
• CPC Class Codes: A61M 1/155 with treatment-fluid pumping means or components thereof
• CPC Class Codes: A61M 1/1561 at least one cassette surface or portion thereof being flexible, e.g. the cassette having a rigid base portion with preformed channels and being covered with a foil
• CPC Class Codes: A61M 1/1565 Details of valves
• CPC Class Codes: A61M 1/159 specially adapted for peritoneal dialysis
• CPC Class Codes: A61M 1/1656 Apparatus for preparing dialysates
• CPC Class Codes: A61M 1/1658 Degasification
• 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 1/285 Catheters therefor
• CPC Class Codes: A61M 1/287 Dialysates therefor
• CPC Class Codes: A61M 1/288 Priming priming in extracorporeal blood circuits A61M1/3643
• CPC Class Codes: A61M 2202/0413 Blood
• CPC Class Codes: A61M 2205/12 with interchangeable cassettes forming partially or totally the fluid circuit
• CPC Class Codes: A61M 2205/3306 Optical measuring means
• CPC Class Codes: A61M 2205/3327 Measuring

Abstract

In a peritoneal dialysis embodiment of the present invention, spent dialysate from the patient'"'"'s peritoneal cavity passes, along a patient loop, through a dialyzer having a membrane that separates waste components from the spent dialysate, wherein the patient loop returns fresh dialysate to the patient'"'"'s peritoneal cavity. The waste components are carried away in a second regeneration loop to a regeneration unit or sorbent cartridge, which absorbs the waste components. The regeneration unit removes undesirable components in the dialysate that were removed from the patient loop by the dialyzer, for example, excess water (ultrafiltrate or UF), toxins and metabolic wastes. Desirable components can be added to the dialysate by the system, such as glucose and electrolytes. The additives assist in maintaining the proper osmotic gradients in the patient to perform dialysis and provide the necessary compounds to the patient.

Claims

1. A system for providing dialysis comprising:

a patient fluid loop including a first pump, a first patient lumen for providing fluid to the patient, and a second patient lumen for removing fluid from the patient;

a multiple lumen connector for connecting with the first and second patient lumens of the patient fluid loop, the connector configured to be sealed by a removable connector end cap such that the pump can prime the patient, wherein the first patient lumen extends further into the multiple lumen connector than the second patient lumen fluid loop prior to being connected to the patient;

a second fluid loop including a second pump, a medical fluid regenerator, and a gas separator that separates gases from the second fluid loop;

a membrane device in fluid contact with and separating the patient fluid loop and the second fluid loop, the membrane device allowing at least one selected component of the fluid in the patient fluid loop to transfer to the second fluid loop;

the second loop being closed except for the transfer of the selected component via the membrane device; and

a controller that operates the first and second pumps to recirculate fluid in the patient loop and the second loop.

2. The dialysis system of claim 1, wherein the membrane device is a dialyzer.

3. The dialysis system of claim 1, wherein a pressure gradient exists across the membrane device.

4. The dialysis system of claim 1, wherein the patient loop is closed except for the transfer of the selected component via the membrane device.

5. The dialysis system of claim 1, wherein the membrane device includes a nanofilter which allows urea to pass from the patient fluid loop to the second fluid loop.

6. The dialysis system of claim 1, wherein the medical fluid regenerator includes a uremic toxin sorbent.

7. The dialysis system of claim 1, wherein the medical fluid regenerator includes at least one of:

urease, zirconium phosphate, zirconium oxide, and carbon.

8. The dialysis system of claim 1, the gas separator being a first gas separator, and which includes a second gas separator that removes gas from the patient loop.

9. The dialysis system of claim 1, wherein the gas separator and the medical fluid regenerator are provided in a single device.

10. The dialysis system of claim 1, wherein the gas separator also separates gases from the patient fluid loop.

11. The dialysis system of claim 1, wherein the second fluid loop includes a multi-analyte sensor that monitors a concentration of electrolytes in the medical fluid.

12. The dialysis system of claim 1, wherein peritoneal dialysis fluid is circulated through the patient fluid loop.

13. The dialysis system of claim 1, wherein blood is circulated through the patient fluid loop.

14. The dialysis system of claim 1, wherein at least parts of the patient fluid loop and the second fluid loop are provided in a disposable device.

15. The dialysis system of claim 1, wherein the second fluid loop includes a balance chamber that balances flow within the second fluid loop.

16. The dialysis system of claim 1, wherein the controller enables fluid to flow in opposite directions through the multiple patient lumens.

17. The dialysis system of claim 1, which includes a dual lumen catheter that defines the multiple patient lumens.

18. The dialysis system of claim 1, wherein at least one of the patient fluid loop and the second fluid loop includes an in-line fluid heater.

19. The dialysis system of claim 18, wherein the in-line fluid heater includes a radiant heater and a plate heater.

20. The dialysis system of claim 1, which includes at least one optical medical fluid sensor that senses at least one indicator selected from the group consisting of:

ammonia, ammonium and pH .

21. The dialysis system of claim 1, which includes a fluid volume sensor in at least one of the patient and second fluid loops.

22. The dialysis system of claim 21, wherein the fluid volume sensor includes a capacitance fluid volume sensor that uses a chamber in fluid communication with the at least one fluid loop.

23. The dialysis system of claim 22, wherein the chamber is a pump chamber.

24. The dialysis system of claim 1, which includes an ultrafiltrate container in fluid communication with at least one of the patient and second fluid loops.

25. The dialysis system of claim 1, which includes a fluid concentrate container in fluid communication with at least one of the patient and second fluid loops.

26. The system of claim 1, wherein the controller operates the first pump continuously to pump fluid into and out of a patient.

27. The dialysis system of claim 1, wherein the multiple lumen connector is configured to connect with a multiple lumen catheter.