DISPOSABLE, PRE-CALIBRATED, PRE-VALIDATED SENSORS FOR USE IN BIO-PROCESSING APPLICATIONS

• US 20090180513A1
• Filed: 03/19/2009
• Published: 07/16/2009
• Est. Priority Date: 12/05/2005
• Status: Active Grant

• Current Assignee: Parker Intangibles LLC (Parker-Hannifin Corporation)
• Original Assignee: SenCal, LLC
• Inventors: Uhen, David, Schick, Karl G.
• Granted Patent: US 8,506,162 B2
• Time in Patent Office: Days
• US Class Current: 374/44
• CPC Class Codes: A61M 1/3621 Extra-corporeal blood circuits single-needle circuits A61M1/30
• CPC Class Codes: A61M 1/3669 Electrical impedance measurement of body fluids; transducers specially adapted therefor
• CPC Class Codes: A61M 2205/6018 providing set-up signals for the apparatus configuration
• CPC Class Codes: G01N 27/10 Investigation or analysis specially adapted for controlling or monitoring operations or for signalling

Abstract

Disposable, pre-sterilized, and pre-calibrated, pre-validated conductivity sensors are provided. These sensors are designed to store sensor-specific information, such as calibration and production information, in a non-volatile memory chip on the sensor on in a barcode printed on the sensor. The sensors are calibrated using 0.100 molar potassium chloride (KCl) solutions at 25 degrees Celsius. These sensors may be utilize with in-line systems, closed fluid circuits, bioprocessing systems, or systems which require an aseptic environment while avoiding or reducing cleaning procedures and quality assurance variances.

Claims

1-10. -10. (canceled)

11. A disposable sensor for measuring the conductivity of a bio-processing fluid, comprising:

a conduit for directing a bio-processing fluid;

a sensing portion, said sensing portion being arranged for sensing conductivity of bio-processing fluid passing through said conduit, said sensing portion having a structure for measuring the temperature;

a barcode printed or etched on the disposable sensor; and

said apparatus is made of inexpensive disposable material suitable for single use of the apparatus.

12. The sensor of claim 11, wherein said barcode is a matrix barcode.

13. The sensor of claim 11, wherein said barcode contains calibration information including a statistical performance value based on individual measurement performances of a plurality of said disposable sensors.

14. The sensor of claim 11, wherein said sensing portion comprises a printed circuit board.

15. The sensor of claim 11, wherein said structure for measuring the temperature of the bio-processing fluid includes at least one thermistor.

16. The sensor of claim 11, wherein said sensing portion is composed of at least one electrode being arranged such that same is in contact with said bio-processing fluid during use of the apparatus.

17. The sensor of claim 16, wherein said sensing portion is composed of four electrodes being arranged such that said electrodes are in contact with said bio-processing fluid during use of the apparatus.

18. The sensor of claim 11, further comprising a user interface, said user interface being connectable with said sensing portion.

19. The sensor of claim 18, wherein said user interface drives a current through the sensing portion, and said user interface is able to calculate the conductivity of the bio-processing fluid.

20. The sensor of claim 18, wherein said user interface has the ability to access or retrieve the data encoded by said barcode.

21. The sensor of claim 11, wherein said barcode is a multidimensional barcode, said barcode being able to encode calibration data, said sensing portion having four electrode pins, and said electrode pins being arranged such that they are in contact with bio-processing fluid passing through said conduit, at least a portion of said conduit and said sensing portion being arranged within a impermeable housing.

22. The sensor of claim 11, wherein said sensing portion also has a memory component.

23. The sensor of claim 22, wherein said memory component stores calibration information including a statistical performance value based on individual measurement performances of a plurality of said disposable sensors.

24. The sensor of claim 22, wherein said memory component is a non-volatile memory chip.

25. The sensor of claim 22, wherein said memory component stores or contains at least the same information as encoded by said barcode.

26. The sensor of claim 25, wherein said component stores or contains additional calibration information not encoded by said barcode.

31. The sensor of claim 22, wherein said memory component is a non-volatile memory chip.

32. The sensor of claim 31, wherein said non-volatile memory chip is an EEPROM.

27-30. -30. (canceled)

33. A user interface for connecting to disposable sensor, comprising:

hardware input and output connections for connecting to a barcode scanner;

hardware input and output connections for connecting to a disposable sensor, said sensor when activated returns analog signals through said hardware connections to the user;

software for interpreting said analog signals;

software for decoding barcodes read by said barcode scanner;

memory for storing said software for interpreting, software for decoding, and information decoded by the software for decoding barcodes.

34. The user interface of claim 33, further comprising:

a display for displaying information related to said analog signals return from said disposable sensor.

35. The user interface of claim 33, wherein said memory component is a non-volatile memory chip.

36. The user interface of claim 35, wherein said non-volatile memory chip is an EEPROM.