Peritoneal dialysis systems and related methods

• US 8,870,811 B2
• Filed: 08/31/2006
• Issued: 10/28/2014
• Est. Priority Date: 08/31/2006
• Status: Active Grant

• Current Assignee: Fresenius Medical Care Holdings Incorporated (Fresenius SE & Co. KGaA)
• Original Assignee: Fresenius Medical Care Holdings Incorporated (Fresenius SE & Co. KGaA)
• Inventors: Gavin, David A., Folden, Thomas I.
• Primary Examiner(s): Sirmons, Kevin C
• Assistant Examiner(s): GRAY, PHILLIP A
• Application Number:
  US11/513,629
• Publication Number:
  US 20080125693A1
• Time in Patent Office: 2,980 Days
• Field of Search: 604/29, 604/131, 604/890.1, 604/500
• US Class Current: 604/29
• CPC Class Codes: A61M 1/152 Details related to the interface between cassette and machine
• 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 1/1562 Details of incorporated reservoirs
• CPC Class Codes: A61M 1/159 specially adapted for peritoneal dialysis
• CPC Class Codes: A61M 1/28 Peritoneal dialysis ; Other peritoneal treatment, e.g. oxygenation
• CPC Class Codes: A61M 1/281 Instillation other than by gravity
• 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 2205/12 with interchangeable cassettes forming partially or totally the fluid circuit

Abstract

Peritoneal dialysis systems and related methods are disclosed. The methods can include combining a first solution having a first concentration of a solute with a second solution having a second concentration of the solute to form a custom dialysate, e.g., according to a specific prescription for a patient.

Claims

1. A method of performing peritoneal dialysis, the method comprising:

receiving input data regarding a prescribed dextrose concentration and a dextrose concentration of each of a plurality of different commercially available, pre-packaged dialysates, wherein the dextrose concentrations of the pre-packaged dialysates differ from one another;

disposing a first dialysate having a first concentration of dextrose in an abdominal cavity of a patient for a first period of time, and then removing the first dialysate from the abdominal cavity of the patient after the first period of time;

after removing the first dialysate from the abdominal cavity of the patient, disposing a second dialysate having a second concentration of dextrose in the abdominal cavity of the patient for a second period of time, and then removing the second dialysate from the abdominal cavity of the patient after the second period of time, the second concentration of dextrose being lower than the first concentration of dextrose; and

after removing the second dialysate from the abdominal cavity of the patient, disposing a third dialysate having a third concentration of dextrose in the abdominal cavity of the patient for a third period of time, and then removing the third dialysate from the abdominal cavity of the patient after the third period of time, the third concentration of dextrose being lower than the second concentration of dextrose,

wherein the first, second, and third dextrose concentrations are determined based on the input data, and wherein disposing the first, second, and third dialysates in the abdominal cavity comprises delivering at least a portion of at least one of the pre-packaged dialysates to the abdominal cavity, and at least one of the first, second, and third dialysates is a mixture of the plurality of pre-packaged dialysates.

2. The method of claim 1, further comprising combining the plurality of pre-packaged dialysates in a mixing container to form the first dialysate.

3. The method of claim 2, further comprising combining the plurality of pre-packaged dialysates in the mixing container to form the second dialysate and the third dialysate.

4. The method of claim 1, further comprising delivering pre-packaged dialysate to a mixing container from a first supply bag.

5. The method of claim 4, wherein delivering the pre-packaged dialysate from the first supply bag to the mixing container comprises pumping the pre-packaged dialysate through a line that fluidly connects the first supply bag to the mixing container.

6. The method of claim 4, further comprising delivering pre-packaged dialysate to the mixing container from a second supply bag.

7. The method of claim 6, wherein delivering the pre-packaged dialysate from the second supply bag to the mixing container comprises pumping the pre-packaged dialysate through a line that fluidly connects the second supply bag to the mixing container.

8. The method of claim 2, wherein the mixing container comprises a heater bag.

9. The method of claim 8, further comprising heating the heater bag such that the first dialysate, when disposed within the heater bag, is warmed.

10. The method of claim 2, wherein the mixing container comprises a fluid line.

11. The method of claim 10, wherein the fluid line is in fluid communication with the abdominal cavity of the patient.

12. The method of claim 10, wherein the first dialysate is heated within the fluid line prior to being disposed within the abdominal cavity of the patient.

13. The method of claim 12, wherein the fluid line comprises a flash heater.

14. The method of claim 2, wherein predetermined volumes of each of the plurality of pre-packaged dialysates are delivered to the mixing container to form the first, second, and third dialysates.

15. The method of claim 14, wherein a pump is actuated in a manner to deliver the predetermined volumes of the plurality of pre-packaged dialysates to the mixing container.

16. The method of claim 15, wherein the pump is in communication with a control unit adapted to control a displacement of the pump, a volume of the plurality of pre-packaged dialysates delivered by the pump being proportional to the displacement of the pump.

17. The method of claim 14, further comprising determining the predetermined volumes of the plurality of pre-packaged dialysates based on desired dextrose concentrations in the first, second, and third dialysates.

18. The method of claim 14, wherein respective volumes of the plurality of pre-packaged dialysates delivered to the mixing container to form the first dialysate differ from respective volumes of the plurality of pre-packaged dialysates delivered to the mixing container to the form the second dialysate, and respective volumes of the plurality of pre-packaged dialysates delivered to the mixing container to form the second dialysate differ from respective volumes of the plurality of pre-packaged dialysates delivered to the mixing container to form the third dialysate.

19. The method of claim 1, wherein the first concentration of dextrose is about 4.25 percent, the second concentration of dextrose is about 4.0 percent, and the third concentration of dextrose is about 3.0 percent.

20. The method of claim 1, wherein the first concentration of dextrose is about 3.0 percent, the second concentration of dextrose is about 2.0 percent, and the third concentration of dextrose is about 1.5 percent.

21. The method of claim 1, wherein the first, second, and third dialysates have first, second, and third concentrations, respectively, of a solute, the first, second, and third concentrations of the solute differing from one another.

22. The method of claim 21, wherein the solute comprises magnesium.

23. The method of claim 1, further comprising disposing an additional substance in the abdominal cavity of the patient.

41. The method of claim 1, wherein the commercially available, pre-packaged dialysates are supplied in bags.

24. A method of performing peritoneal dialysis treatment, the method comprising:

combining a dialysate concentrate having a dextrose concentration of ten percent to 30 percent, a calcium concentration of about 5.9 mEq/L to about 70 mEq/L, and a magnesium concentration of about 1.2 mEq/L to about 30 mEq/L with a diluent to form a first dialysate, wherein the diluent is reverse osmosis water or saline;

disposing the first dialysate in an abdominal cavity of a patient for a first period of time; and

removing the first dialysate from the abdominal cavity of the patient after the first period of time.

25. The method of claim 24, wherein the diluent comprises reverse osmosis water.

26. The method of claim 24, further comprising:

combining the dialysate concentrate with the diluent to form a second dialysate, the second dialysate having a dextrose concentration that differs from a dextrose concentration of the first dialysate;

disposing the second dialysate in the abdominal cavity of the patient for a second period of time; and

removing the second dialysate from the abdominal cavity of the patient after the second period of time.

27. The method of claim 26, wherein respective volumes of the dialysate concentrate and diluent combined to form the second dialysate differ from respective volumes of the dialysate concentrate and diluent combined to form the first dialysate.

28. The method of claim 26, further comprising:

combining the dialysate concentrate with the diluent to form a third dialysate, the third dialysate having a dextrose concentration that differs from dextrose concentrations of the first and second dialysates;

disposing the third dialysate in the abdominal cavity of the patient for a third period of time; and

removing the third dialysate from the abdominal cavity of the patient after the third period of time.

29. The method of claim 24, further comprising disposing another substance in the abdominal cavity of the patient.

30. A peritoneal dialysis system, comprising:

a first container containing a dialysate concentrate having a dextrose concentration of ten percent to 30 percent, a calcium concentration of about 5.9 mEq/L to about 70 mEq/L, and a magnesium concentration of about 1.2 mEq/L to about 30 mEq/L;

a second container containing a diluent, wherein the diluent is reverse osmosis water or saline;

a mixing container in fluid communication with the first and second containers; and

a pump configured to pump metered amounts of the dialysate concentrate and the diluent to the mixing container to form a dialysate.

31. The peritoneal dialysis system of claim 30, further comprising a control unit in communication with the pump, the control unit adapted to control the amounts of the dialysate concentrate and diluent that are pumped to the mixing container.

32. The peritoneal dialysis system of claim 31, wherein the control unit is adapted to control the amounts of the dialysate concentrate and diluent that are pumped to the mixing container based on a desired concentration of a solute in a dialysate to be formed in the mixing container upon combining the dialysate concentrate and diluent.

33. The peritoneal dialysis system of claim 32, wherein the control unit is adapted to receive input data and to control amounts of the dialysate concentrate and diluent that are pumped to the mixing container based on the input data.

34. The peritoneal dialysis system of claim 33, wherein the input data comprises a dialysate prescription.

35. The peritoneal dialysis system of claim 32, wherein the solute comprises dextrose.

36. The peritoneal dialysis system of claim 32, wherein the solute comprises calcium.

37. The peritoneal dialysis system of claim 32, wherein the solute comprises magnesium.

38. The peritoneal dialysis system of claim 30, wherein the mixing container comprises a heater bag.

39. The peritoneal dialysis system of claim 38, further comprising a heating element adapted to heat dialysate within the heater bag.

40. The peritoneal dialysis system of claim 30, wherein the diluent comprises reverse osmosis water.