Filtration system for preparation of fluids for medical applications

• US 8,679,348 B2
• Filed: 04/11/2011
• Issued: 03/25/2014
• Est. Priority Date: 01/07/2003
• Status: Active Grant

• Current Assignee: Nxstage Medical Incorporated (Fresenius SE & Co. KGaA)
• Original Assignee: Nxstage Medical Incorporated (Fresenius SE & Co. KGaA)
• Inventors: Burbank, Jeffrey H., Green, Brian C., Treu, Dennis M., McDowell, Christopher S., Friederichs, Goetz
• Primary Examiner(s): Menon, Krishnan S
• Application Number:
  US13/083,915
• Publication Number:
  US 20110186521A1
• Time in Patent Office: 1,079 Days
• Field of Search: None
• US Class Current: 210/670
• 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

Systems, methods, and devices for preparation of water for various uses including blood treatment are described. In embodiments, fluid is passed either by pump or passively by gravity feed, through various filtration elements from a fluid source to a treatment 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 which provides multiple benefits and liabilities to overcome, as discussed herein. Mechanisms for preparing pure water for infusion or medicaments are described such as elimination of chlorine and colloidal aluminum. Also various control mechanisms to help avoid contamination are describe.

Claims

1. A method of providing a treatment fluid, comprising:

providing a water purification plant with a replaceable component having first and second filter stages, each stage being sufficient to purify the water to the same target level of purity and thereby the stages being redundant;

providing a breakthrough water quality sensor between the first and second stages;

receiving a command to produce a batch of purified water;

determining whether the replaceable component is expired responsive to a data carrier affixed to the replaceable component;

responsively to a result of the determining, pumping unpurified water through the first stage and then through the second stage into a batch container if the replaceable component is determined to be unexpired and preventing pumping if the replaceable component is expired;

conditioned on detecting a breakthrough of contamination responsively to the water quality sensor, continuing the pumping to flow a predetermined amount of water into the batch container while the second stage provides the target level of purity and thereafter preventing the pump from flowing water through the replaceable component until the replaceable component is replaced; and

after replacing the replaceable component, repeating the determining and pumping using a new replaceable component,

wherein the first filter stage has a substantially larger capacity than the second stage.

2. The method of claim 1, wherein the water quality sensor is a conductivity cell.

3. The method of claim 1, wherein the first filter stage includes a separate deionization filter with separate cation and anion beds.

4. The method of claim 1, wherein the first filter stage includes a separate deionization filter with separate cation and anion beds, and the second filter stage includes a mixed cation-anion bed.

11. The method of claim 1, further comprising performing a medical treatment within a predefined period of time after producing the batch of purified water.

15. The method of claim 1, wherein the replaceable component is configured as a single unit such that the first and second stages are replaced simultaneously and the method further includes replacing the replaceable component responsively to, and upon, the detection of the breakthrough of contamination and responsively to, and upon, the completion of the flowing of the predetermined amount of water.

17. The method of claim 15, further comprising performing a medical treatment within a predefined period of time after producing the batch of purified water.

5. A method of providing a treatment fluid, comprising:

providing a water purification system having a replaceable component, the replaceable component including first and second redundant filter stages, each filter stage being sufficient alone to purify water passing therethrough to a same target level of purity, a water quality sensor being arranged between the first and second filter stages;

responsive to a command to produce a batch of purified water, determining whether the replaceable component is expired based on information contained in a data carrier affixed to the replaceable component;

when it is determined that the replaceable component is expired, preventing pumping of water through the replaceable component;

when it is determined that the replaceable component is not expired, pumping water through the replaceable component, including the at least a first and second redundant filter stages thereof, into a batch container; and

when, during said pumping, a breakthrough of contamination is detected by said water quality sensor, continuing the pumping to flow a predetermined amount of water into the batch container, the target level of purity of the water during the continuing the pumping being provided by the second redundant filter stage alone; and

after said continuing the pumping, preventing subsequent pumping of water through the replaceable component,

wherein the first filter stage has a substantially larger capacity than the second stage.

6. The method of claim 5, wherein said preventing subsequent pumping includes updating the data carrier of the replaceable component to indicate that the replaceable component is expired.

7. The method of claim 5, further comprising:

replacing the replaceable component with a new replaceable component; and

repeating the determining and the pumping with the new replaceable component.

8. The method of claim 5, wherein the pumping through the replaceable component is such that the water flows through the first filter stage and then the second filter stage.

9. The method of claim 5, wherein the water quality sensor is a conductivity cell.

10. The method of claim 5, wherein the first filter stage includes a separate deionization filter with separate cation and anion beds, and the second filter stage includes a mixed cation-anion bed.

12. The method of claim 5, further comprising performing a medical treatment within a predefined period of time after producing the batch of purified water.

16. The method of claim 5, wherein the replaceable component is configured as a single unit such that the first and second stages are replaced simultaneously and the method further includes replacing the replaceable component responsively to, and upon, the detection of the breakthrough of contamination and responsively to, and upon, the completion of the flowing of the predetermined amount of water.

18. The method of claim 16, further comprising performing a medical treatment within a predefined period of time after producing the batch of purified water.

13. A method of providing a treatment fluid, comprising:

providing a water purification plant with a replaceable component having first and second filter stages, each stage being sufficient to purify the water to the same target level of purity and thereby the stages being redundant;

providing a breakthrough water quality sensor between the first and second stages;

receiving a command to produce a batch of purified water;

determining whether the replaceable component is expired responsive to a data carrier affixed to the replaceable component;

responsively to a result of the determining, pumping unpurified water through the first stage and then through the second stage into a batch container if the replaceable component is determined to be unexpired and preventing pumping if the replaceable component is expired;

conditioned on detecting a breakthrough of contamination responsively to the water quality sensor, continuing the pumping to flow a predetermined amount of water into the batch container while the second stage provides the target level of purity and thereafter preventing the pump from flowing water through the replaceable component until the replaceable component is replaced; and

after replacing the replaceable component, repeating the determining and pumping using a new replaceable component,

wherein the replaceable component is configured as a single unit such that the first and second stages are replaced simultaneously and the method further includes replacing the replaceable component responsively to, and upon, the detection of the breakthrough of contamination and responsively to, and upon, the completion of the flowing of the predetermined amount of water.

19. The method of claim 13, wherein the water quality sensor is a conductivity cell.

20. The method of claim 13, wherein the first filter stage includes a separate deionization filter with separate cation and anion beds.

21. The method of claim 13, wherein the first filter stage includes a separate deionization filter with separate cation and anion beds, and the second filter stage includes a mixed cation-anion bed.

22. The method of claim 13, further comprising performing a medical treatment within a predefined period of time after producing the batch of purified water.

14. A method of providing a treatment fluid, comprising:

providing a water purification system having a replaceable component, the replaceable component including first and second redundant filter stages, each filter stage being sufficient alone to purify water passing therethrough to a same target level of purity, a water quality sensor being arranged between the first and second filter stages;

responsive to a command to produce a batch of purified water, determining whether the replaceable component is expired based on information contained in a data carrier affixed to the replaceable component;

when it is determined that the replaceable component is expired, preventing pumping of water through the replaceable component;

when it is determined that the replaceable component is not expired, pumping water through the replaceable component, including the at least a first and second redundant filter stages thereof, into a batch container; and

when, during said pumping, a breakthrough of contamination is detected by said water quality sensor, continuing the pumping to flow a predetermined amount of water into the batch container, the target level of purity of the water during the continuing the pumping being provided by the second redundant filter stage alone; and

after said continuing the pumping, preventing subsequent pumping of water through the replaceable component,

wherein the replaceable component is configured as a single unit such that the first and second stages are replaced simultaneously and the method further includes replacing the replaceable component responsively to, and upon, the detection of the breakthrough of contamination and responsively to, and upon, the completion of the flowing of the predetermined amount of water.

23. The method of claim 14, wherein said preventing subsequent pumping includes updating the data carrier of the replaceable component to indicate that the replaceable component is expired.

24. The method of claim 14, further comprising:

replacing the replaceable component with a new replaceable component; and

repeating the determining and the pumping with the new replaceable component.

25. The method of claim 14, wherein the pumping through the replaceable component is such that the water flows through the first filter stage and then the second filter stage.

26. The method of claim 14, wherein the water quality sensor is a conductivity cell.

27. The method of claim 14, wherein the first filter stage includes a separate deionization filter with separate cation and anion beds, and the second filter stage includes a mixed cation-anion bed.

28. The method of claim 14, further comprising performing a medical treatment within a predefined period of time after producing the batch of purified water.