SERVICE-DETECTABLE ANALYTE SENSORS AND METHODS OF USING AND MAKING SAME

• US 20100270180A1
• Filed: 04/28/2009
• Published: 10/28/2010
• 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: FELDMAN, BENJAMIN J., CHO, BRIAN, LIU, ZENGHE
• Granted Patent: US 8,359,081 B2
• Time in Patent Office: Days
• US Class Current: 205/794.500
• 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. An analyte sensor comprising:

a working electrode comprising a sensing layer disposed proximate thereto;

a counter electrode; and

an indicator element that provides a sensor service history.

2. The analyte sensor of claim 1, wherein the sensor service history comprises differentiating a previously used sensor from a previously unused sensor.

3. The analyte sensor of claim 2, wherein an indicator element of a previously unused sensor provides an electrochemical current that is different than an indicator element of a previously used sensor.

4. The analyte sensor of claim 3, wherein the electrochemical current of the indicator element of the previously unused sensor is greater than the electrochemical current of the indicator element of the previously used sensor.

5. The analyte sensor of claim 2, wherein an indicator element of a previously unused sensor provides an electrochemical potential that is different than an indicator element of a previously used sensor.

6. The analyte sensor of claim 1, wherein the indicator element is an electroreactive compound.

7. The analyte sensor of claim 6, wherein the electroreactive compound is silver metal (Ag).

8. The analyte sensor of claim 1, wherein the indicator element is Ag/AgCl.

9. The analyte sensor of claim 6, wherein the electroreactive compound is a metal nanopowder.

10. The analyte sensor of claim 9, wherein the metal nanopowder comprises aluminum, iron, copper, nickel, magnesium, titanium, or titanium nitride.

11. The analyte sensor of claim 1, wherein the indicator element is a non-leachable electroreactive substance.

12. The analyte sensor of claim 1, wherein the indicator element is a leachable electroreactive substance.

13. The analyte sensor of claim 12, wherein the leachable electroreactive substance is uric acid, dopamine, ascorbic acid, or acetaminophen.

14. The analyte sensor of claim 1, wherein the indicator element is deposited on the working electrode or the counter electrode.

15. The analyte sensor of claim 1, wherein the sensing layer comprises the indicator element.

16. The analyte sensor of claim 1, wherein at least a portion of the electrochemical analyte sensor is adapted to be subcutaneously positioned in a subject.

17. The analyte sensor of claim 1, further comprising a membrane disposed over the sensing layer.

18. The analyte sensor of claim 1, wherein the sensing layer comprises a glucose-responsive enzyme.

19. The analyte sensor of claim 1, wherein the sensing layer comprises a redox mediator.

20. The analyte sensor of claim 19, wherein the redox mediator comprises a ruthenium-containing complex or an osmium-containing complex.

21. The analyte sensor of claim 19, wherein the sensor is a glucose sensor.

22. The analyte sensor of claim 19, wherein the sensor is an in vivo sensor.

23. The analyte sensor of claim 19, wherein the sensor is an in vitro sensor.

24. A method for determining a service history of an analyte sensor, comprising:

positioning at least a portion of an analyte sensor into skin of a subject, wherein the sensor comprises;

a working electrode comprising a sensing layer disposed proximate thereto;

a counter electrode; and

an indicator element that provides a sensor service history; and

determining the sensor service history of the analyte sensor.

25. The method of claim 24, wherein the determining the sensor service history comprises applying an initializing potential to the indicator element and comparing a current generated by the indicator element to a control current.

26. The method of claim 25, 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.

27. The method of claim 25, wherein the initializing potential is applied for at least about 10 seconds.

28. The method of claim 24, wherein the sensor service history comprises differentiating a previously used sensor from a previously unused sensor.

29. The method of claim 24, 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.

30. The method of claim 24, 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.

31. The method of claim 24, wherein an indicator element of a previously unused sensor provides an electrochemical potential that is different than an indicator element of a previously used sensor.

32. The method of claim 24, wherein the control current is a current generated by an indicator element of a previously unused sensor

33. The method of claim 24, wherein the control current is a current generated by an indicator element of a previously used sensor

34. The method of claim 24, wherein the indicator element is an electroreactive compound.

35. The method of claim 34, wherein the electroreactive compound is silver metal (Ag).

36. The method of claim 24, wherein the indicator element is Ag/AgCl.

37. The method of claim 34, wherein the electroreactive compound is a metal nanopowder.

38. The method of claim 37, wherein the metal nanopowder comprises aluminum, iron, copper, nickel, magnesium, titanium, or titanium nitride.

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

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

41. The method of claim 40, wherein the leachable electroreactive substance is uric acid, dopamine, ascorbic acid, or acetaminophen.

42. The method of claim 24, wherein the indicator element is deposited on the working electrode or the counter electrode.

43. The method of claim 24, wherein the sensing layer comprises the indicator element.

44-88. -88. (canceled)