Rapid-read gated amperometry devices

• US 9,034,160 B2
• Filed: 02/21/2012
• Issued: 05/19/2015
• Est. Priority Date: 12/10/2007
• Status: Active Grant

• Current Assignee: Ascensia Diabetes Care Holdings AG (PHC Holdings Corporation)
• Original Assignee: Bayer Healthcare LLC (Bayer AG)
• Inventors: Wu, Huan-Ping
• Primary Examiner(s): Van, Luan
• Assistant Examiner(s): Kessel, Maris R
• Application Number:
  US13/401,222
• Publication Number:
  US 20120211361A1
• Time in Patent Office: 1,183 Days
• Field of Search: 20440301-40315, 204/406, 204/407, 436/50, 435/286.1, 435/287.1, 435/287.3, 435/287.9, 422/62, 422/63, 422/67, 422/68.1, 422/82.01, 422/108, 205/775, 205/777.5, 205/792
• US Class Current: 204/406
• CPC Class Codes: G01N 27/327 Biochemical electrodes , e.g. electrical or mechanical details for in vitro measurements
• CPC Class Codes: G01N 27/3273 Devices therefor, e.g. test element readers, circuitry details not specific to biochemical electrodes G01N33/4875

Abstract

A sensor system, device, and methods for determining the concentration of an analyte in a sample is described. Input signals including multiple duty cycles of sequential excitation pulses and relaxations are input to the sample. One or more signals output from the sample within 300 ms of the input of an excitation pulse may be correlated with the analyte concentration of the sample to improve the accuracy and/or precision of the analysis. Determining the analyte concentration of the sample from these rapidly measured output values may reduce analysis errors arising from the hematocrit effect, mediator background, and other error sources.

Claims

1. A handheld measurement device, comprising:

a sensor interface adapted to receive a sensor strip, the sensor interface including at least two contacts;

at least one display; and

electronic circuitry establishing electrical communication between the at least two contacts and the display,

where the electronic circuitry includes a signal generator and a processor in electrical communication,

where the processor is in electrical communication with a storage medium having computer readable software code,

where the processor is programmed to cause the signal generator to provide an input signal between the at least two contacts,

where the input signal has at least 3 duty cycles within 10 seconds, where each of the at least 3 duty cycles includes an excitation pulse and a relaxation,

where the processor is programmed to measure at least one current value at the at least two contacts within 300 milliseconds of the signal generator applying an excitation pulse having a pulse width from 0.3 to 0.8 second of at least one duty cycle of the at least 3 duty cycles, and

where the processor is programmed to determine an analyte concentration in a biological fluid or a derivative of a biological fluid in response to the at least one current value.

2. The measurement device of claim 1, where the signal generator is selected from the group consisting of an electric charger and a generator-recorder.

3. The measurement device of claim 2, where the signal generator is an electric charger.

4. The measurement device of claim 1, where the computer readable software code includes correlation equations.

5. The measurement device of claim 4, where the correlation equations are selected from the group consisting of program number tables, look-up tables, and combinations thereof.

6. The measurement device of claim 1, where the processor is programmed to measure the at least one current value during a transient portion of a current decay.

7. The measurement device of claim 6, where the processor is programmed to determine the analyte concentration in the biological fluid or the derivative of the biological fluid in response to the at least one current value measured during the transient portion of the current decay.

8. The measurement device of claim 1, where the processor is programmed to measure the at least one current value within less than 175 milliseconds from the start of the excitation pulse having the pulse width from 0.3 to 0.8 second of the at least one duty cycle.

9. The measurement device of claim 1, where the processor is programmed to apply at least one data treatment to the at least one current value.

10. The measurement device of claim 9, where the at least one data treatment determines at least one of a decay rate, a K constant, and a ratio value.

11. The measurement device of claim 3, where the processor is programmed to measure the at least one current value at the at least two contacts as a function of time while the electric charger provides the input signal between the contacts.

12. The measurement device of claim 3, where the input signal the electric charger is programmed to provide between the at least two contacts comprises at least 4 duty cycles within 7 seconds.

13. The measurement device of claim 3, where the input signal the electric charger is programmed to provide between the at least two contacts comprises square-wave excitations.

14. The measurement device of claim 3, where the electric charger is programmed to implement the excitation pulses at a substantially constant voltage.

15. The measurement device of claim 3, where the electric charger is programmed to provide a pulse width of the excitation pulse from 0.3 to 0.5 seconds.

16. The measurement device of claim 3, where the electric charger is programmed to provide a pulse width of the excitation pulse from 0.3 to 0.5 seconds, and a pulse interval of at least one of the at least 3 duty cycles from 0.7 to 2 seconds.

17. The measurement device of claim 3, where the input signal the electric charger is programmed to provide between the at least two contacts comprises a terminal read pulse not followed by a relaxation.

18. The measurement device of claim 3, where the processor is programmed to cause the electric charger to provide a pulse interval of at least one of the at least 3 duty cycles that is less than 3 seconds.

19. The measurement device of claim 3, where the processor is programmed to cause the electric charger to provide the relaxation including a current reduction to at least one-half the current flow at an excitation maxima of the excitation pulse.

20. The measurement device of claim 3, where the processor is programmed to cause the electric charger to provide the relaxation including a current reduction to at least an order of magnitude less than the current flow at an excitation maxima of the excitation pulse.

21. The measurement device of claim 3, where the processor is programmed to cause the electric charger to provide the relaxation including a substantially zero current flow.

22. The measurement device of claim 3, where the processor is programmed to measure the at least one current value from the at least one duty cycle applied by the electric charger within 7 seconds of the electric charger applying an initial excitation pulse to the sample.

23. The measurement device of claim 1, where the processor is programmed to measure the at least one current value at the at least two contacts within 60 to 150 milliseconds of the charger applying the excitation pulse having the pulse width from 0.3 to 0.8 second.

24. The measurement device of claim 3,

where the processor is programmed to cause the electric charger to provide an open circuit between the at least two contacts, and

where the open circuit provides the relaxation and where the relaxation is at least 0.5 seconds.

25. The measurement device of claim 1,

where the input signal the signal generator is configured to provide between the at least two contacts is capable of exciting a measurable species internal to a diffusion barrier layer, and

where the processor is programmed to measure the at least one current value at the at least two contacts from the measurable species internal to the diffusion barrier layer while substantially excluding from measuring the measurable species external to a diffusion barrier layer.

26. A biosensor system, comprising:

a sensor strip having a sample interface adjacent to a reservoir formed by the sensor strip; and

a measurement device having a processor connected to a sensor interface,

where the sensor interface has electrical communication with the sample interface,

where the processor has electrical communication with a storage medium,

where the processor is programmed to determine an output signal value responsive to the concentration of an analyte in a sample from the sensor interface within 300 milliseconds of applying an excitation pulse having a pulse width from 0.3 to 0.8 second to the sample interface, and

where the excitation pulse is part of an input signal having at least 3 duty cycles within 10 seconds, where each duty cycle includes an excitation pulse and a relaxation.

27. The system of claim 26, where the measurement device is portable.

28. The system of claim 26, where the excitation pulse has a substantially constant voltage.

29. The system of claim 26, where the processor is programmed to determine the output signal value responsive to the concentration of the analyte in the sample during a transient portion of a current decay.

30. The system of claim 26, where a pulse interval of at least one of the at least 3 duty cycles is less than 3 seconds.

31. The system of claim 26, where a pulse width of the excitation pulse is from 0.3 to 0.5 seconds, and where a pulse interval of at least one of the at least 3 duty cycles is from 0.7 to 2 seconds.

32. The system of claim 26, where the relaxation includes a current reduction to at least one-half the current flow at an excitation maxima of the excitation pulse.

33. The system of claim 26, where the relaxation includes a current flow reduction to at least an order of magnitude less than the current flow at an excitation maxima of the excitation pulse.

34. The system of claim 26, where the relaxation includes a substantially zero current flow.

35. The system of claim 26, where the processor is programmed to determine the output signal value responsive to the concentration of the analyte in the sample within 60 to 150 milliseconds of applying the excitation pulse to the sample interface.

36. The system of claim 26, where the relaxation is at least 0.5 seconds and is responsive to an open circuit.

37. The system of claim 26, where the sample is at least one of a biological fluid and a derivative of a biological fluid.