Filtration system for preparation of fluids for medical applications

• US 10,420,871 B2
• Filed: 06/06/2017
• Issued: 09/24/2019
• 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., Treu, Dennis M., Friederichs, Goetz, Green, Brian C., McDowell, Christopher S., Brugger, James M.
• Primary Examiner(s): Menon, Krishnan S
• Application Number:
  US15/615,655
• Publication Number:
  US 20170266360A1
• Time in Patent Office: 840 Days
• Field of Search: None
• 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 fluid preparation system has a sealed sterilized fluid circuit with a sealed sterilized container with a conductivity sensor in communication with an interior of said container. Further, at least one sealed connector is adapted for adding fluid to said container, and at least one sealed connector is adapted for removing fluid from said container. The conductivity sensor is contained in a test line in communication with said interior and is adapted to be connected to a source of suction thereby to draw a sample of contents of said container. Furthermore, the test line may have a check valve to prevent ingress of contaminants into said container, and the sealed connector is adapted for adding fluid to said container and may have an inline sterile filter. Furthermore, the system may have a controller that controls pumping actuators.

Claims

1. A fluid preparation system, comprising:

a disposable component with preconnected tubing, the disposable component including a sealed sterilized fluid circuit that includes

a sealed sterilized container;

a conductivity sensor preconnected to the container and in communication with an interior of said container;

at least one sealed connector adapted for adding fluid to said container;

at least one sealed connector adapted for removing fluid from said container, wherein

said conductivity sensor is contained in a test line that is preconnected to the container, the test line being in communication with said interior and adapted to be connected to a source of suction thereby to draw a sample of contents of said container, and

wherein the conductivity sensor includes a cage that prevents a wall of the container from coming into contact with conductivity sensor.

2. A system as in claim 1, wherein said test line includes a check valve to prevent ingress of contaminants into said container.

3. A system as in claim 2, wherein said at least one sealed connector is adapted for adding fluid to said container and includes an inline sterile filter.

4. A system as in claim 1, wherein said at least one sealed connector is adapted for adding fluid to said container and includes an inline sterile filter.

5. A system as in claim 3, further comprising:

a controller;

pumping actuators;

clamps controlled by the controller; and

a deionization water purifier with a product water outlet having a connector for connection to said sterile filter.

6. A system as in claim 4, further comprising:

a controller;

pumping actuators;

clamps controlled by the controller; and

a deionization water purifier with a product water outlet having a connector for connection to said sterile filter.

7. A system as in claim 1, further comprising:

a controller;

pumping actuators;

clamps controlled by the controller; and

a deionization water purifier with a product water outlet having a connector for connection to a sterile filter.

8. The system of claim 7, wherein the fluid circuit includes a quantity of medicament concentrate.

9. The system of claim 8, wherein said controller is programmed to pump said concentrate into said sterilized container and to dilute the same using water from the product water outlet.

10. The system of claim 9, wherein the controller reads a fluid quality sensor reading from said conductivity sensor and controls a pump to continue or discontinue pumping responsively to said sensor reading.

11. The system of claim 10, wherein said controller is programmed to maintain a clamp on a mixed fluid outlet of said sterilized container responsively to said sensor reading.

12. The system of claim 5, wherein the fluid circuit includes a quantity of medicament concentrate.

13. The system of claim 12, wherein said controller is programmed to pump said concentrate into said sterilized container and to dilute the same using water from the product water outlet.

14. The system of claim 13, wherein the controller reads a fluid quality sensor reading from said conductivity sensor and controls a pump to continue or discontinue pumping responsively to said sensor reading.

15. The system of claim 14, wherein said controller is programmed to maintain a clamp on a mixed fluid outlet of said sterilized container responsively to said sensor reading.

16. A fluid preparation system, comprising:

a sealed sterilized fluid circuit with a sealed sterilized container with a conductivity sensor in communication with an interior of said container;

at least one sealed connector adapted for adding fluid to said container;

at least one sealed connector adapted for removing fluid from said container, wherein

the container is connected, through an opening, to a test line in communication with said interior that is adapted to be connected to a source of suction thereby to draw a sample of contents of said container past the conductivity sensor;

said opening includes a cage that prevents a flexible wall of the container from coming into contact with the opening and blocking flow through said opening.

17. The system according to claim 16, wherein

the cage of the conductivity sensor is sealed to one wall of the container.