Multi-Region and Potential Test Sensors, Methods, and Systems

• US 20100267161A1
• Filed: 03/22/2010
• Published: 10/21/2010
• Est. Priority Date: 09/24/2007
• Status: Active Grant

• Current Assignee: Ascensia Diabetes Care Holdings AG (PHC Holdings Corporation)
• Original Assignee: Bayer Healthcare LLC (Bayer AG)
• Inventors: Maurer, Eric, Jung, Sung-Kwon, Wu, Huan-Ping, Perry, Joseph E., Zhong, Weiping
• Granted Patent: US 9,846,136 B2
• Time in Patent Office: Days
• US Class Current: 436/149
• CPC Class Codes: C12Q 1/001 Enzyme electrodes
• CPC Class Codes: G01N 27/3272 Test elements therefor, i.e. disposable laminated substrates with electrodes, reagent and channels optical biosensors G01N33/52
• CPC Class Codes: G01N 27/3274 Corrective measures, e.g. error detection, compensation for temperature or hematocrit, calibration coding of calibration information G01N33/48771

Abstract

Biosensor systems including a measurement device and test sensors including at least three independently addressable electrodes, with at least two of the electrodes being substantially chemically isolated are disclosed. One or more working electrodes may be combined with two or more counter electrodes. The two or more counter electrodes may operate at different potentials to provide for multi-analyte electrochemical analysis. Analysis methods are provided to perform multi-analyte electrochemical analysis and test sensors are provided having resistance to chemical mixing between secondary analysis regions.

Claims

1. An analyte test sensor, comprising:

at least two substrates forming a reservoir, the reservoir having at least two substantially chemically isolated secondary analysis regions;

at least one first working electrode including a first conductor and a reagent composition disposed in the reservoir;

at least one first counter electrode including a second conductor and at least one first redox species disposed in a first secondary analysis region; and

at least one second counterelectrode including a third conductor and at least one second redox species disposed in a second secondary analysis region, where

the working electrode, the first counter electrode, and the second counter electrodes are independently addressable, and

at least one of the substantially chemically isolated secondary analysis regions has only one electrode.

2. The test sensor of claim 1, where the first secondary analysis region opposes the second secondary analysis region across a primary area.

3. The test sensor of claim 1, where the first and second secondary analysis regions are staggered on opposing sides of a primary area.

4. The test sensor of claim 2, where the first and second secondary analysis regions are staggered on opposing sides of a primary area.

5. The test sensor of claim 2, where at least one of the secondary analysis regions branch from the primary area at an angle other than 90°

.

7. The test sensor of claim 4, where at least one of the secondary analysis regions branch from the primary area at an angle other than 90°

.

8. The test sensor of claim 2, where at least one of the secondary analysis regions branch from the primary area at an angle of less than 90°

.

9. The test sensor of claim 3, where at least one of the secondary analysis regions branch from the primary area at an angle of less than 90°

.

10. The test sensor of claim 4, where at least one of the secondary analysis regions branch from the primary area at an angle of less than 90°

.

11. The test sensor of claim 1 comprising a third substantially chemically isolated secondary analysis region, the first working electrode disposed in the third secondary analysis region and substantially chemically isolated from at least one of the first counter electrode and the second counter electrode.

12. The test sensor of claim 10 comprising a third substantially chemically isolated secondary analysis region, the first working electrode disposed in the third secondary analysis region and substantially chemically isolated from at least one of the first counter electrode and the second counter electrode.

13. The test sensor of claim 11, where the reservoir is a multi-T-channel design.

14. The test sensor of claim 11, where the reservoir is a multi-Y-channel design.

15. The test sensor of claim 11, the first working electrode substantially chemically isolated from the first counter electrode and the second counter electrode.

16. The test sensor of claim 11, each secondary analysis region with one electrode.

17. The test sensor of claim 11 comprising at least four substantially chemically isolated secondary analysis regions, each region with one electrode.

18. The test sensor of claim 17, where two of the electrodes are working and two of the electrodes are counter.

19. The test sensor of claim 17, where one of the electrodes is working and three of the electrodes are counter.

20. The test sensor of claim 18, where the two working electrodes are addressed together electrically.

21. The test sensor of claim 1, the substantially chemically isolated secondary analysis regions arranged so that when the biological fluid enters the reservoir and flows to the secondary analysis regions, the biological fluid does not flow across more than one electrode to reach another electrode.

22. The test sensor of claim 10, the substantially chemically isolated secondary analysis regions arranged so that when the biological fluid enters the reservoir and flows to the secondary analysis regions, the biological fluid does not flow across more than one electrode to reach another electrode.

23. The test sensor of claim 1, where a straight line passing through the substantially chemically isolated secondary analysis regions cannot be drawn between any two electrodes.

24. The test sensor of claim 10, where a straight line passing through the substantially chemically isolated secondary analysis regions cannot be drawn between any two electrodes.

25. The test sensor of claim 1, the first and second counter electrodes configured to operate at different potentials.

26. The test sensor of claim 10, the first and second counter electrodes configured to operate at different potentials.

27. The test sensor of claim 25, where the different potentials are separated by at least 50 mV.

28. The test sensor of claim 29, where the different potentials are separated by at least 50 mV.

29. The test sensor of claim 25, where the first and the second redox species are different, the difference selected from the group consisting of a metal verses an electroactive organic molecule and the elemental identity of a metal.

30. The test sensor of claim 29, where the first and the second redox species are different, the difference selected from the group consisting of a metal verses an electroactive organic molecule and the elemental identity of a metal.

31. The test sensor of claim 25, where the different potential configuration is provided by first and second redox species have different ratios of the conjugates of a redox pair.

32. The test sensor of claim 26, where the different potential configuration is provided by first and second redox species have different ratios of the conjugates of a redox pair.

33. The test sensor of claim 1, further comprising at least one reference electrode.

34. The test sensor of claim 10, further comprising at least one reference electrode.

6. The test sensor of 3, where at least one of the secondary analysis regions branch from the primary area at an angle other than 90°

.

35-50. -50. (canceled)

51. An analyte test sensor, the test sensor comprising:

at least two substrates forming a reservoir, the reservoir including at least one primary area, a first secondary analysis region, and a second secondary analysis region,

the first secondary analysis region including a working electrode, the working electrode formed from a reagent composition and a first conductor,

the second secondary analysis region including one counter electrode, the counter electrode formed from a charge transfer system and a second conductor;

at least one sample port in fluid communication with the reservoir;

a first vent in fluid communication with the first secondary analysis region; and

a second vent in fluid communication with the second secondary analysis region, where

a straight line passing from the working electrode through the first secondary analysis region and through the primary area cannot be drawn through the second secondary analysis region to the counter electrode.

52-57. -57. (canceled)

58. An analyte test sensor, comprising:

a conductor disposed between two substrates; and

at least one portion of a reservoir including a sample port defined at least by the two substrates and an edge of the conductor, the edge of the conductor defining at least a first electrode.

59. An analyte test sensor, comprising:

at least two substrates forming a reservoir, the sample reservoir including at least one primary area, at least one sample port, at least one vent, and at least a first, a second, and a third substantially chemically isolated secondary analysis region,

the first secondary analysis region including at least one first electrode in electrical communication with a first conductor,

the second secondary analysis region including at least one second electrode in electrical communication with a second conductor,

the third secondary analysis region including at least one third electrode in electrical communication with a third conductor, where

a fluid sample entering the at least one sample port does not flow across more than one of the first, the second, and the third electrodes to reach another electrode.

60. An analyte test sensor, comprising;

at least two substrates forming a reservoir, the sample reservoir including at least one primary area and at least one first and at least one second substantially chemically isolated secondary analysis region,

the first secondary analysis region including at least one first electrode having a first redox species in electrical communication with a first conductor,

the second secondary analysis region including at least one second electrode having a second redox species in electrical communication with a second conductor, the second redox species is different than the first redox species, where

when a sample consisting essentially of a pH 7 phosphate buffer, 0.1 M sodium phosphate, and 16% (w/w) polyvinyl pyrrolidone polymer having a weight average molecular weight of 2000 is introduced to the first and the second secondary analysis regions at an atmospheric relative humidity of 45% and at a temperature of 22°

C., mixing of the first and the second redox species is not observed by an analysis technique selected from the group consisting of cyclic voltammetry and chemoamperometry within 12 minutes if the test sensor is not mechanically disturbed.

61-63. -63. (canceled)

64. A method of measuring at least one analyte in a sample, the method comprising:

chemically or biochemically oxidizing or reducing at least one analyte in a sample;

applying a first input signal to the sample with at least a first working electrode and a first counter electrode;

applying a second input signal at a different potential than the first input signal to the sample with at least the first working electrode and a second counter electrode;

analyzing the output signals from the first and the second input signals to determine

a concentration of a first measurable species in the sample at the potential of the first counter electrode, and

a concentration of a second measurable species in the sample at the potential of the second counter electrode; and

converting at least one of the first and the second measurable species concentrations into the concentration of the at least one analyte in the sample.

65-68. -68. (canceled)

69. A method of measuring at least one analyte in a sample, the method comprising:

introducing the sample to a test sensor including at least two pairs of electrodes, the at least two pairs of electrodes including at least four independently addressable and substantially chemically isolated electrodes, where at least two of the electrodes are working electrodes and at least two of the electrodes are counter electrodes;

chemically or biochemically oxidizing or reducing the analyte in the sample;

applying a gated input signal to the sample across the at least two pairs of electrodes to generate at least two output signals;

combining the at least two output signals; and

measuring the concentration of the analyte in the sample from the combined output signals.

70-75. -75. (canceled)

76. An analyte biosensor system, comprising:

at least two substrates forming a reservoir, the reservoir including at least one primary area, at least one sample port, at least two vents, and at least a first and a second substantially chemically isolated secondary analysis regions,

the first secondary analysis region including at least one first electrode in electrical communication with a first conductor,

the second secondary analysis region including at least one second electrode in electrical communication with a second conductor;

a sample interface in electrical communication with the first conductor, the second conductor, and a third conductor in the reservoir; and

a sensor interface in electrical communication with the sample interface;

a processor in electrical communication with the sensor interface, the processor is operable to determine the time when a fluid sample entering the reservoir contacts the first electrode and the time when a fluid sample entering the sample reservoir contacts the second electrode.

77-78. -78. (canceled)

79. An analyte biosensor system, comprising:

a test sensor including a sample interface disposed on a first substrate, where the sample interface is in electrical communication with a reservoir formed by the first substrate and a second substrate,

where the reservoir has at least one sample port and at least a first and a second substantially chemically isolated secondary analysis region, and

where the test sensor has

at least one first working electrode disposed in the reservoir, where the at least one first working electrode has a third conductor,

at least one first counter electrode having a first conductor and at least one first redox species disposed in the first substantially chemically isolated region,

at least one second counter electrode having a second conductor and at least one second redox species disposed in the second substantially chemically isolated region, where the working electrode, first counter electrode, and second counter electrode are independently addressable;

a sample interface in electrical communication with the first conductor, the second conductor, and the third conductor;

a measurement device including a computer readable storage medium, a processor, and a signal generator, where the signal generator is in electrical communication with the sensor interface, and where the sensor interface is in electrical communication with the sample interface;

where the processor is operable to apply

a first input signal at a first potential from the signal generator to the at least one working electrode and the at least one first counter electrode,

a second input signal at a second potential from the signal generator to the at least one working electrode and the at least one second counter electrode;

where the processor is operable to measure

a first output signal from the at least one working electrode and the at least one first counter electrode, where the first output signal is responsive to the first input signal, and

a second output signal from the at least one working electrode and the at least one second counter electrode, where the second output signal is responsive to the second input signal;

where the processor is operable to analyze the first and the second output signals;

where the processor is operable to determine

a first concentration of at least one first measurable species in a biological sample disposed in the reservoir at the potential of the first input signal,

a second concentration of at least one second measurable species in the biological sample disposed in the reservoir at the potential of the second input signal; and

where the processor is operable to convert at least one of the first and the second concentrations into a concentration of the analyte in the biological sample disposed in the reservoir.

80-83. -83. (canceled)