Biosensor calibration system

• US 8,206,564 B2
• Filed: 07/23/2007
• Issued: 06/26/2012
• Est. Priority Date: 07/23/2007
• Status: Active Grant

• Current Assignee: Ascensia Diabetes Care Holdings AG (PHC Holdings Corporation)
• Original Assignee: Bayer Healthcare LLC (Bayer AG)
• Inventors: Schell, Robert D., Perry, Joseph E.
• Primary Examiner(s): TEIXEIRA MOFFAT, JONATHAN CHARLES
• Application Number:
  US11/781,425
• Publication Number:
  US 20090030617A1
• Time in Patent Office: 1,800 Days
• Field of Search: 204/403.03
• US Class Current: 204/403.03
• CPC Class Codes: G01N 33/48771 Coding of information, e.g. calibration data, lot number

Abstract

A biosensor system determines an analyte concentration using one or more calibrated correlation equations for an optical and/or electrochemical analysis of a biological fluid. The biosensor system may be implemented using a measurement device and a sensor strip. The measurement device senses circuit patterns on an encoding pattern of the sensor strip. The measurement device determines calibration information in response to the circuit patterns, and uses the calibration information to calibrate one or more of the correlation equations. The measurement device uses the calibrated correlation equations to determine the analyte concentration.

Claims

1. A biosensor system for determining an analyte concentration in a biological fluid, comprising:

a measurement device having a processor connected to a pattern read device;

a sensor strip including a counter electrode and a working electrode, the sensor strip further having an encoding pattern with at least two circuits, where each circuit forms a circuit pattern, and where each circuit pattern has a unique set of contact areas, each circuit pattern being separate from the counter electrode or the working electrode;

where the measurement device and sensor strip implement an analyte analysis, where the analyte analysis has at least one correlation equation;

where the pattern read device senses the at least two circuit patterns on the encoding pattern, the shape of the at least two circuit patterns corresponding to a mapping of a digital representation;

where the processor determines calibration information responsive to the at least two circuit patterns;

where the processor calibrates the at least one correlation equation responsive to the calibration information; and

where the processor determines the analyte concentration responsive to at least one calibrated correlation equation.

2. The biosensor of claim 1, where the pattern read device selectively applies test signals to the encoding pattern.

3. The biosensor of claim 2, where the pattern read device drives at least one test signal to ground.

4. The biosensor of claim 3, where the pattern read device applies at least one other test signal at a pull-up voltage.

5. The biosensor of claim 3, where the pattern read device comprises a plurality of test circuits, where a first test circuit drives a first test signal to ground during a first step, and where a second test circuit drives a second test signal to ground during a second step.

6. The biosensor of claim 5, where a third test circuit drives a third test signal to ground during a third step.

7. The biosensor of claim 1, where each of the at least two circuits has at least two contact areas.

8. The biosensor of claim 1, where at least one of the at least two circuits has at least two contact areas and at least one of the at least two circuits has on contact area.

9. The biosensor of claim 1, where the test signals are current limited.

10. The biosensor of claim 9, where the test signals are less than about 50 μ

A.

11. The biosensor of claim 1, where the pattern read device generates a pattern signal responsive to the circuit patterns.

12. The biosensor of claim 1, where the at least two circuits include a first circuit, a second circuit, and at least one isolated circuit, where the first and second circuits each have at least two contact areas, and where the at least one isolated circuit has one contact area.

13. The biosensor of claim 1, where the processor checks for errors in the calibration information.

14. The biosensor of claim 13, where the processor enforces at least one rule regarding a total number of circuits and a total number of isolated circuits.

15. The biosensor of claim 13, where the processor determines whether a count of the circuit patterns matches the number of circuits on the encoding pattern.

16. The biosensor of claim 13, further comprising at least one of a predefined fixed number of isolated contacts on the encoding pattern and another predefined fixed number of circuits on the encoding pattern.

17. The biosensor of claim 13, where the processor determines whether one single contact circuit is detected.

18. A biosensor system for determining an analyte concentration in a biological fluid, comprising:

a measurement device having a processor connected to a pattern read device, where the pattern read device has an array of electrical contacts;

a sensor strip including a counter electrode and a working electrode, the sensor strip further having an encoding pattern with at least two circuits, where each circuit forms a circuit pattern, and where each circuit pattern has a unique set of contact areas, where the contact areas are in electrical communication with the electrical contacts, each circuit pattern being separate from the counter electrode or the working electrode;

where the measurement device and sensor strip implement an analyte analysis, where the analyte analysis has at least one correlation equation;

where the electrical contacts selectively apply test signals to the contact areas on the encoding pattern;

where the pattern read device senses the at least two circuit patterns on the encoding pattern, the shape of the at least two circuit patterns corresponding to a mapping of a digital representation;

where the processor determines calibration information responsive to the at least two circuit patterns;

where the processor calibrates the at least one correlation equation responsive to the calibration information; and

where the processor determines the analyte concentration responsive to at least one calibrated correlation equation.

19. The biosensor of claim 18, comprising an encoding pattern with a single-contact circuit and a multiple-contact circuit.

20. The biosensor of claim 18, comprising a pattern read device with a plurality of test circuits, where at least one of the test circuits drives a test signal to ground in response to a control signal from the processor.

21. The biosensor of claim 18, comprising an encoding pattern with a first circuit, a second circuit, and at least one isolated circuit.

22. The biosensor of claim 18, where the processor checks for errors in the calibration information, and where the processor enforces at least one rule regarding a total number of circuits and a total number of isolated circuits.

23. The biosensor of claim 18, where the processor checks for errors in the calibration information, and where the processor determines whether a count of the circuit patterns matches the number of circuits on the encoding pattern.

24. The biosensor of claim 18, where the processor checks for errors in the calibration information, and where the encoding pattern has at least one of a predefined fixed number of isolated contacts and another predefined fixed number of circuits.

25. The biosensor of claim 18, where the processor checks for errors in the calibration information, and where the processor determines whether one single contact circuit is detected.

26. A method for determining an analyte concentration in a biological fluid, comprising:

providing a sensor strip including a counter electrode and a working electrode, the sensor strip further including an encoding pattern with at least two circuits, each circuit forming a circuit pattern, each circuit pattern having a unique set of contact areas, each circuit pattern being separate from the counter electrode or the working electrode;

sensing the at least two circuit patterns on the encoding pattern, the shape of the at least two circuit patterns corresponding to a mapping of a digital representation;

determining calibration information in response to the at least two circuit patterns;

calibrating at least one correlation equation in response to the calibration information; and

determining the analyte concentration in response to at least one calibrated correlation equation.

27. The method of claim 26, further comprising selectively applying test signals to the encoding pattern.

28. The method of claim 27, further comprising limiting the current of the test signals.

29. The method of claim 28, further comprising:

applying test signals to the encoding pattern; and

driving at least one test signal to ground.

30. The method of claim 26, further comprising checking for errors in the calibration information.

31. The method of claim 30, further comprising determining whether a count of the circuit patterns matches the number of circuits on the encoding pattern.

32. The method of claim 30, where the encoding pattern has at least one of a predefined fixed number of isolated contacts and another predefined fixed number of circuits.

33. The method of claim 30, further comprising detecting whether the encoding pattern has one single contact circuit.