Service-detectable analyte sensors and methods of using and making same

• US 9,717,450 B2
• Filed: 11/06/2015
• Issued: 08/01/2017
• Est. Priority Date: 04/28/2009
• Status: Active Grant

• Current Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Inventors: Cho, Brian, Liu, Zenghe, Feldman, Benjamin J.
• Primary Examiner(s): JANG, CHRISTIAN YONGKYUN
• Application Number:
  US14/935,064
• Publication Number:
  US 20160058352A1
• Time in Patent Office: 634 Days
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/14546 for measuring analytes not otherwise provided for, e.g. ions, cytochromes
• CPC Class Codes: A61B 5/1473 invasive, e.g. introduced into the body by a catheter A61B5/1482 takes precedence
• CPC Class Codes: A61B 5/14865 invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors
• CPC Class Codes: A61B 5/1495 Calibrating or testing of in-vivo probes
• CPC Class Codes: A61B 5/4839 combined with drug delivery
• CPC Class Codes: A61B 5/72 Signal processing specially adapted for physiological signals or for diagnostic purposes character recognition, recognising digital ink, document-oriented image-based pattern recognition G06V30/00; recognition or understanding of postal images G06V30/424
• CPC Class Codes: A61B 5/742 using visual displays A61B5/339 takes precedence
• CPC Class Codes: A61B 5/746 Alarms related to a physiological condition, e.g. details of setting alarm thresholds or avoiding false alarms alarms per se G08B
• CPC Class Codes: G01N 33/48771 Coding of information, e.g. calibration data, lot number

Abstract

Generally, embodiments of the invention relate to analyte determining devices (e.g., electrochemical analyte monitoring systems) that include an indicator element that provides information relating to service history of the analyte determining devices, including, for example, previous use of the analyte determining devices. Also provided are systems and methods of using the, for example electrochemical, analyte determining devices in analyte monitoring.

Claims

1. A method, comprising:

applying an initializing potential to an indicator element of an analyte sensor positioned beneath the skin of a patient, wherein the indicator element provides a sensor service history and the analyte sensor is electrically coupled to an analyte sensor control unit positioned on the skin of the patient;

detecting a current generated by the indicator element; and

comparing the detected current to a control current to determine a sensor service history of the analyte sensor to identify the sensor as a previously used sensor or a previously unused sensor.

2. The method of claim 1, wherein the initializing potential is a positive potential from about 1 mV to about 500 mV or a negative potential from about 1 mV to about 500 mV.

3. The method of claim 1, wherein the initializing potential is applied for at least about 10 seconds.

4. The method of claim 1, wherein the sensor is identified as a previously unused sensor, the method further comprises:

collecting data, using the analyte sensor control unit, regarding a level of an analyte from signals generated by the analyte sensor;

transmitting the collected data from the sensor control unit to a receiver unit, wherein the sensor control is integrated with the analyte sensor.

5. The method of claim 4, wherein the analyte is glucose.

6. The method of claim 4, wherein collecting data comprises generating signals from the sensor and processing the signals into data.

7. The method of claim 4, wherein the data comprises the signals from the sensor.

8. The method of claim 4, further comprising activating an alarm if the data indicates an alarm condition.

9. The method of claim 4, further comprising administering a drug in response to the data.

10. The method of claim 9, wherein the drug is insulin.

11. The method of claim 4, further comprising obtaining a calibration value from a calibration device to calibrate the data.

12. The method of claim 11, wherein the calibration device is coupled to a display unit.

13. The method of claim 12, further comprising transmitting the calibration value from a transmitter in the display unit to a receiver in the sensor control unit.

14. The method of claim 1, wherein a current generated by an indicator element of a previously unused sensor is different than a current generated by an indicator element of a previously used sensor.

15. The method of claim 1, wherein a current generated by an indicator element of a previously unused sensor is greater than a current generated by an indicator element of a previously used sensor.

16. The method of claim 1, wherein the control current is a current generated by an indicator element of a previously unused sensor.

17. The method of claim 1, wherein the control current is a current generated by an indicator element of a previously used sensor.

18. The method of claim 1, wherein the indicator element is an electroreactive compound.

19. The method of claim 18, wherein the electroreactive compound is silver metal (Ag).

20. The method of claim 1, wherein the indicator element is Ag/AgCl.

21. The method of claim 18, wherein the electroreactive compound is a metal nanopowder.

22. The method of claim 21, wherein the metal nanopowder comprises aluminum, iron, copper, nickel, magnesium, titanium, or titanium nitride.

23. The method of claim 1, wherein the indicator element is a non-leachable electroreactive substance.

24. The method of claim 1, wherein the indicator element is a leachable electroreactive substance.

25. The method of claim 24, wherein the leachable electroreactive substance is uric acid, dopamine, ascorbic acid, or acetaminophen.

26. The method of claim 1, wherein the indicator element is deposited on the working electrode or the counter electrode.

27. The method of claim 1, wherein the indicator element is disposed in a sensing layer.

28. The method of claim 27, wherein the sensing layer comprises a redox mediator.

29. The method of claim 28, wherein the sensing layer further comprises a polymer.

30. The method of claim 29, wherein the redox mediator is covalently bonded to the polymer.