Filtration System for Preparation of Fluids for Medical Applications

• US 20080230450A1
• Filed: 01/09/2006
• Published: 09/25/2008
• Est. Priority Date: 01/07/2005
• Status: Active Grant

• Current Assignee: Nxstage Medical Incorporated (Fresenius Medical Care AG)
• Original Assignee: Nxstage Medical Incorporated (Fresenius Medical Care AG)
• Inventors: Brugger, James M., Treu, Dennis M., Burbank, Jeffrey H., Green, Brian C., Friederichs, Gotz, McDowell, Christopher S.
• Granted Patent: US 9,700,663 B2
• Time in Patent Office: Days
• US Class Current: 210/92
• 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 1/1668 Details of containers
• 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. Methods and systems for creating multiple-treatment batches are described. Advantages of creating a multitreatment batch include the fact that the burden of treatment preparation can be reduced and the timing of the preparation of the batch can be independent of the treatment time. As described, there are various trade-offs and concerns with this approach which are addressed by the inventive embodiments.

Claims

1. A medical fluid treatment device, comprising:

a housing having water supply and drain connections and an electrical supply connection;

a treatment fluid preparation device configured to purify water, and use said purified water to dilute a solute to prepare a batch of a purified water;

said batch being contained in a disposable container enclosed in said housing;

said batch containing enough treatment fluid to perform multiple renal replacement therapy treatments each being at least a day apart;

a heater configured to maintain a temperature of said batch at a temperature for immediate use in renal replacement therapy;

a controller configured to indicate at least one of;

an indication that said batch has expired, is about to expire, an amount of time before said batch will expire;

said controller being configured to make said batch available for multiple treatments;

connections for connecting a renal replacement therapy device to receive contents of said batch.

2. A device as in claim 1, wherein said disposable container is a bag and said housing has a tank portion configured to support said bag.

3. A device as in claim 2, wherein said bag includes a first filter that is replaced each time said bag is replaced.

4. A device as in claim 1, wherein said housing has a table top surface and said table top is configured to support said renal replacement therapy device.

5. A device as in claim 1, wherein said housing has a table top surface and a height not greater than 1 m.

6. A device as in claim 1, wherein said treatment fluid preparation device includes a disposable filtration module that is replaced one every multiple batches.

7. A device as in claim 1, wherein said disposable container is a bag and said housing has a tank portion configured to support said bag, said tank portion being configured as a drawer portion that is hidden behind a door on front of said housing.

8. A device as in claim 1, wherein:

said housing has a table top surface and a height not greater than 1 m.;

said table top is uninterrupted by any fixtures;

said controller has a user interface mounted on a front of said housing.

9. A device as in claim 1, wherein said housing has a table top surface and a height not greater than 75 cm.

10. A device as in claim 1, wherein said disposable container has multiple outlet connections, each configured with a non-reopenable clamp.

11. A device as in claim 1, wherein said treatment fluid includes a lactate based dialysate.

12. A device as in claim 1, wherein said housing is fitted with wheels.

13. A device as in claim 1, wherein said disposable container is a bag and said housing has a recess portion configured to support said bag, said recess having a bottom on which said bag sits, said bottom being at a bottom of said housing and having at least one leak sensor therein.

14. A device as in claim 1, wherein said housing has at least one leak sensor outside of any fluid containing or conveying component to detect leaks.

15. A device as in claim 1, wherein said controller is configured to empty said batch after use.

16. A device as in claim 1, wherein said drain connection includes a Y-junction receiving a connection from said disposable container and a connector for connection to a spent fluid line of said treatment machine.

17. A device as in claim 16, wherein one leg of said Y-junction includes a conductivity sensor configured to allow said controller to test a sample of said batch by flushing a portion thereof into said Y-junction.

18. A device as in claim 1, wherein said disposable container includes an actuator portion with a filter that is replaced for each batch.

19. A device as in claim 18, wherein said treatment fluid preparation device includes a filter that is replaced once every multiple batches.

20. A device as in claim 1, further comprising a pump and fluid circuit portion configured to generate a constant pressure for uptake by said treatment device.

21. A device as in claim 20, wherein said fluid circuit portion is a feedback loop that returns to said disposable container and includes an inline check valve with a cracking pressure equal to said constant pressure.

22. A device as in claim 1, further comprising a valve actuator assembly configured to draw concentrate from a container and supply said concentrate to said disposable container, to rinse said concentrate container and supply a diluted fluid that results from rinsing said concentrate container to said disposable container.