Devices using gated voltammetry methods

• US 10,670,553 B2
• Filed: 11/07/2017
• Issued: 06/02/2020
• Est. Priority Date: 09/30/2005
• Status: Active Grant

• Current Assignee: Ascensia Diabetes Care Holdings AG (PHC Holdings Corporation)
• Original Assignee: Ascensia Diabetes Care Holdings AG (PHC Holdings Corporation)
• Inventors: Wu, Huan-Ping
• Primary Examiner(s): Ball, J. Christopher
• Application Number:
  US15/805,575
• Publication Number:
  US 20180059048A1
• Time in Patent Office: 938 Days
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/1486 using enzyme electrodes, e.g. with immobilised oxidase
• CPC Class Codes: C12Q 1/001 Enzyme electrodes
• CPC Class Codes: G01N 27/3273 Devices therefor, e.g. test element readers, circuitry details not specific to biochemical electrodes G01N33/4875
• CPC Class Codes: G01N 27/3274 Corrective measures, e.g. error detection, compensation for temperature or hematocrit, calibration coding of calibration information G01N33/48771
• CPC Class Codes: G01N 27/413 Concentration cells using liquid electrolytes measuring currents or voltages in voltaic cells
• CPC Class Codes: G01N 33/5438 Electrodes

Abstract

A sensor system, device, and methods for determining the concentration of an analyte in a sample is described. Gated voltammetric pulse sequences including multiple duty cycles of sequential excitations and relaxations may provide a shorter analysis time and/or improve the accuracy and/or precision of the analysis. The disclosed pulse sequences may reduce analysis errors arising from the hematocrit effect, variance in cap-gap volumes, non-steady-state conditions, mediator background, a single set of calibration constants, under-fill, and changes in the active ionizing agent content of the sensor strip.

Claims

1. A method of determining a concentration of an analyte in a fluid sample comprising:

applying a pulse sequence having at least one duty cycle to the fluid sample, the at least one duty cycle of the pulse sequence including an excitation and a relaxation;

measuring one or more current values obtained from the excitation of the at least one duty cycle of the pulse sequence;

determining the concentration of the analyte based on the measured one or more current values and one or more previously determined calibration constants; and

responsive to the concentration of the analyte being less than a predetermined threshold concentration range,

(i) continuing to apply the pulse sequence for one or more additional duty cycles such that one or more additional excitations are applied to the fluid sample,

(ii) measuring one or more additional current values obtained from the one or more additional excitations of the one or more additional duty cycles, and

(iii) determining the concentration of the analyte based on the measured one or more current values of the at least one duty cycle, the measured one or more additional current values from the one or more additional duty cycles, and the one or more previously determined calibration constants.

2. The method of claim 1, wherein the pulse sequence is a gated voltammetric pulse sequence.

3. The method of claim 1, wherein each duty cycle has an excitation/relaxation time ratio from 0.3 to 0.2.

4. The method of claim 3, wherein each duty cycle has an excitation/relaxation time ratio from 0.27 to 0.22.

5. The method of claim 1, wherein the relaxations of the pulse sequence include a current reduction to at least one-half the current flow at an excitation maxima.

6. The method of claim 1, wherein the excitations are acyclic and substantially exclude a reverse oxidation peak or a reverse reduction peak of a measurable species responsive to the concentration of the analyte in the sample.

7. The method of claim 1, wherein the pulse sequence includes at least three duty cycles within 90 seconds or at least three duty cycles within 5 seconds, prior to determining the concentration of the analyte.

8. The method of claim 1, wherein the excitations include a potential varied with time.

9. The method of claim 8, wherein the potential varied with time is varied linearly at a rate of at least 2 mV/sec.

10. The method of claim 1, wherein a duration of the excitations is between about 0.1 and about 3 seconds, between about 0.1 and about 2 seconds, between about 0.1 and about 1.5 seconds, or between about 0.4 and about 1.2 seconds.

11. The method of claim 1, wherein a duration of the excitations is less than about 3 seconds, less than about 2 seconds, less than about 1.5 seconds, or less than about 1 second.

12. The method of claim 1, wherein the one or more additional duty cycles applied after initially determining the concentration of the analyte are identical to the at least one duty cycle applied prior to initially determining the concentration of the analyte.

13. The method of claim 1, wherein the predetermined threshold concentration range is between about 150 mg/dL and about 200 mg/dL.

14. The method of claim 1, wherein the one or more additional duty cycles comprises at least two duty cycles, such that at least two excitations are applied to the fluid sample after initially determining the concentration of the analyte is less than the predetermined threshold concentration range.

15. The method of claim 1, wherein the one or more additional excitations comprises at least four duty cycles, such that at least four excitations are applied to the fluid sample after initially determining the concentration of the analyte is less than the predetermined threshold concentration range.

16. The method of claim 1, wherein the at least one duty cycle includes three duty cycles, and wherein the one or more additional duty cycles includes at least two duty cycles.

17. The method of claim 1, wherein the at least one duty cycle includes three duty cycles, and wherein the one or more additional duty cycles includes at least four duty cycles.

18. The method of claim 1, wherein the at least one duty cycle comprises three duty cycles, and wherein the method further comprises, responsive to the concentration of the analyte being greater than the predetermined threshold concentration range, (i) continuing to apply the pulse sequence for a single additional duty cycle such that a single additional excitation is applied to the fluid sample, (ii) measuring one or more additional current values obtained from the single additional excitation of the single additional duty cycle, and (iii) determining the concentration of the analyte based on the measured one or more current values of the at least one duty cycle, the measured one or more additional current values from the single additional duty cycle, and the one or more previously determined calibration constants.

19. The method of claim 18, wherein responsive to the concentration of the analyte being less than the predetermined threshold concentration range, the pulse sequence is continued to be applied for two or more additional duty cycles such that two or more additional excitations are applied to the fluid sample.

20. The method of claim 18, wherein responsive to the concentration of the analyte being less than the predetermined threshold concentration range, the pulse sequence is continued to be applied for four or more additional duty cycles such that four or more additional excitations are applied to the fluid sample.