BATCH FILTRATION SYSTEM FOR PREPARATION OF STERILE FLUID FOR RENAL

• US 20070007208A1
• Filed: 07/07/2005
• Published: 01/11/2007
• Est. Priority Date: 01/07/2003
• Status: Active Grant

• Current Assignee: Nxstage Medical Incorporated (Fresenius Medical Care AG)
• Original Assignee: Nxstage Medical Incorporated (Fresenius Medical Care AG)
• Inventors: Brugger, James, Burbank, Jeffrey, Green, Brian
• Granted Patent: US 7,544,300 B2
• Time in Patent Office: Days
• US Class Current: 210/645
• CPC Class Codes: A61M 1/14 Dialysis systems; Artificial kidneys; Blood oxygenators semi-permeable membranes characterised by the material, manufacturing processes therefor B01D71/00; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
• CPC Class Codes: A61M 1/1656 Apparatus for preparing dialysates
• CPC Class Codes: A61M 1/166 Heating for sterilisation A61M1/1686
• CPC Class Codes: A61M 1/167 Flexible packaging for solid concentrates
• CPC Class Codes: A61M 1/1672 using membrane filters, e.g. for sterilising the dialysate
• CPC Class Codes: A61M 1/1674 using UV radiation sources for sterilising the dialysate
• 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 1/3462 Circuits for the preparation thereof
• CPC Class Codes: A61M 2205/12 with interchangeable cassettes forming partially or totally the fluid circuit
• CPC Class Codes: C02F 1/44 by dialysis, osmosis or reverse osmosis general membrane separation processes B01D61/00, membrane modules B01D63/00, electrodialysis C02F1/4693, combination of membrane modules and bioreactors C02F3/1268

Abstract

A method and device for blood treatments that use fluids such as dialysate and replacement fluid for renal replacement therapy. In an embodiment, fluid is passed either by pump or passively by gravity feed, through a microporous sterilization filter from a fluid source to a replacement fluid container. The latter forms a batch that may be used during treatment. The advantage of forming the batch before treatment is that the rate of filtering needn'"'"'t match the rate of consumption during treatment. As a result, the sterilization filter can have a small capacity. In another embodiment, a filter is placed immediately prior to the point at which the sterile fluid is consumed by the treatment process. The latter may be used in combination with the former embodiment as a last-chance guarantee of sterility and/or that the fluid is free of air bubbles. It may also be used as the primary means of sterile-filtration.

Claims

1. A method of administering a renal replacement therapy requiring a sterile fluid, comprising the steps of:

at least one of carbon-filtering, deionizing, and ultra-filtering water to produce a source fluid;

sterile-filtering the source fluid to generate a sterile fluid;

flowing said sterile fluid into a sterile batch container;

said steps of sterile-filtering and flowing including performing said steps at a location and time at which a patient is to be treated using sterile fluid from the batch container; and

flowing said sterile fluid from said sterile batch container to a treatment system, wherein at least one of said steps of sterile-filtering and flowing includes automatically controlling at least one of a flow rate of said sterile fluid and a rate of heating of said sterile fluid responsively to data representing at least one of a statement start time and a volume of said fluid infusible fluid required for a treatment.

2. A method of administering a rental replacement therapy requiring a sterile fluid, comprising:

deionizing water to generate a source fluid;

sterile-filtering the source fluid to generate sterile water, the sterile-filtering include passing the water through an ultrafilter;

flowing the sterile water into a sterile batch container that contains dialysate concentrate to produce a solution;

the sterile-filtering and flowing including performing the steps at a location and time at which a patient is to be treated using the solution; and

flowing the solution from the sterile batch container to a treatment system, wherein the sterile-filtering includes automatically controlling a flow volume responsively to a treatment start time, a volume of the solution required for a treatment, and a required concentration of the solution.

3. The method of claim 2, wherein the flow rate associated with the flowing of purified water into the batch container is lower than a rate of the flowing of the solution from the sterile batch container for treatment.

4. The method of claim 3, further comprising heating fluid in the batch container at rate that is lower than required to heat water from room temperature to body temperature based on the flow rate of the flowing of the solution from the sterile batch container for treatment.

5. The method of claim 2, further comprising heating water in the batch container at rate that is lower than required to heat water from room temperature to body temperature based on the flow rate of the flowing of the solution from the sterile batch container for treatment.

6. The method of claim 2, further comprising exposing water to ultra-violet light 245 nm wavelength and an output power of 750 mJ/cm² up to 1500 mJ/cm².

7. The method of claim 2, further comprising carbon filtering the water with activated carbon sufficient to substantially eliminate chloramines.

8. The method of claim 2, further comprising repeating the flowing the of purified fluid into a batch container over multiple iterations and then replaced a deionization filter.

9. The method of claim 8, wherein the deionizing includes flowing water through a resistivity sensor and then flowing the water from the sensor through a mixed bed deionization filter;

the method further comprising detecting an output of the resistivity sensor and automatically preventing a further use of a deionization filter responsively to a result of the detecting.

10. The method of claim 2, wherein the deionizing includes flowing water through a first strong acid cation bed, followed by a first strong base anion bed, followed by a second strong acid cation bed, followed by a second strong base anion bed.

11. The method of claim 2, wherein the deionizing includes flowing water through a resistivity sensor and then flowing the water from the sensor through a mixed bed deionization filter;

the method further comprising detecting an output of the resistivity sensor and automatically preventing a further use of a deionization filter responsively to a result of the detecting.

12. A method of administering a renal replacement therapy requiring a sterile fluid, comprising:

deionization-filtering water to produce deionized water;

ultrafiltering the deionized water to generate purified water;

providing a sterile batch container containing a predefined quantity of concentrate;

flowing the purified fluid into the batch container to generate a solution;

storing the solution in the batch container;

the filtering, providing, and flowing being done at a location and time at which a patient is to be treated using the solution; and

flowing the solution from the sterile batch container to a treatment system;

wherein the flowing of the purified fluid into the batch container includes automatically controlling a flow rate responsively to data representing a volume of the fluid infusible fluid required for a treatment.

13. The method of claim 12, wherein the fluid flow rate associated with the flowing of purified water into the batch container is lower than a rate of the flowing of the solution from the sterile batch container for treatment.

14. The method of claim 13, further comprising heating fluid in the batch container at rate that is lower than required to heat water from room temperature to body temperature based on the flow rate of the flowing of the solution from the sterile batch container for treatment.

15. The method of claim 12, further comprising heating water in the batch container at rate that is lower than required to heat water from room temperature to body temperature based on the flow rate of the flowing of the solution from the sterile batch container for treatment.

16. The method of claim 12, further comprising exposing water to ultra-violet light at 245 nm wavelength and an output power of 750 mJ/cm² up to 1500 mJ/cm².

17. The method of claim 12, further comprising carbon filtering the water with activated carbon sufficient to substantially eliminate chloramines.

18. The method of claim 12, further comprising repeating the flowing the of purified fluid into a batch container over multiple iterations and then replaced a deionization filter.

19. The method of claim 18, wherein the deionization-filtering includes flowing water through a resistivity sensor and then flowing the water from the sensor through a mixed bed deionization filter;

the method further comprising detecting an output of the resistivity sensor and automatically preventing a further use of a deionization filter responsively to a result of the detecting.

20. The method of claim 12, wherein the deionization-filtering includes flowing water through a first strong acid cation bed, followed by a first strong base anion bed, followed by a second strong acid cation bed, followed by a second strong base anion bed.

21. The method of claim 12, wherein the deionization-filtering includes flowing water through a resistivity sensor and then flowing the water from the sensor through a mixed bed deionization filter;

the method further comprising detecting an output of the resistivity sensor and automatically preventing a further use of a deionization filter responsively to a result of the detecting.