Self-powered analyte sensor

• US 9,668,684 B2
• Filed: 03/04/2010
• Issued: 06/06/2017
• Est. Priority Date: 02/26/2009
• Status: Active Grant

• Current Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Inventors: Liu, Zenghe, Ouyang, Tianmei, Feldman, Benjamin
• Primary Examiner(s): WEARE, MEREDITH H
• Application Number:
  US12/717,634
• Publication Number:
  US 20100213082A1
• Time in Patent Office: 2,651 Days
• Field of Search: 600345-347
• CPC Class Codes: A61B 5/0004 characterised by the type of physiological signal transmitted
• 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: A61B 5/6849 in combination with a needle set
• CPC Class Codes: A61B 90/98 using electromagnetic means, e.g. transponders
• CPC Class Codes: C12Q 1/005 involving specific analytes or enzymes including groups of enzymes, e.g. oxydases; C12Q1/004 takes precedence
• CPC Class Codes: C12Q 1/006 for glucose
• 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 27/4035 Combination of a single ion-sensing electrode and a single reference electrode G01N27/406 and G01N27/413 take precedence
• CPC Class Codes: Y02E 60/50 Fuel cells

Abstract

Generally, embodiments of the invention relate to self-powered analyte determining devices (e.g., electrochemical analyte monitoring systems) that include a working electrode, a counter electrode, and an optional resistance value, where the working electrode includes analyte sensing components and the self-powered analyte determining device spontaneously passes a current directly proportional to analyte concentration in the absence of an external power source. Also provided are systems and methods of using the, for example electrochemical, analyte sensors in analyte monitoring.

Claims

1. An intermittently interrogated analyte measuring system, comprising:

an analyte sensor assembly, comprising;

a self-powered electrochemical analyte sensor comprising;

a working electrode comprising an analyte-responsive enzyme disposed on the working electrode, wherein the working electrode is configured and arranged for electrooxidizing or electroreducing a primary reactant in the presence of the analyte-responsive enzyme;

a counter electrode capable of electroreducing or electrooxidizing a secondary reactant; and

a resistor disposed between the working electrode and counter electrode, wherein the resistor comprises an R value,

wherein the self-powered electrochemical analyte sensor maintains a current output directly proportional to analyte concentration in the absence of any reference voltage,

wherein the R value is chosen from within a range of R values for which the current output is independent of the R value at an analyte concentration at the top of its physically relevant range; and

a data processing unit in communication with the self-powered electrochemical analyte sensor; and

a first wireless communication unit in communication with the data processing unit; and

a handheld device comprising a second wireless communication unit,

wherein the analyte sensor assembly is configured for intermittent interrogation by the handheld device via the first wireless communication unit and the second wireless communication unit only upon positioning of the handheld device in close proximity to the analyte sensor assembly by the subject.

2. The system of claim 1, wherein the first wireless communication unit comprises a first radio-frequency communication protocol.

3. The system of claim 2, wherein the first radio frequency communication protocol is a first RFID communication protocol.

4. The system of claim 1, wherein the second wireless communication unit comprises a second radio-frequency communication protocol.

5. The system of claim 4, wherein the second radio frequency communication protocol is a second RFID communication protocol.

6. The system of claim 1, wherein the analyte sensor assembly further comprises a radio-frequency powered current measuring circuit coupled to the analyte sensor.

7. The system of claim 6, wherein the radio-frequency powered current measuring circuit is intermittently powered.

8. The system of claim 1, wherein the analyte sensor assembly further comprises an inductively powered current measuring circuit coupled to the analyte sensor.

9. The system of claim 8, wherein the inductively powered current measuring circuit is intermittently powered.

10. The system of claim 1, wherein the handheld device comprises a personal data assistant (PDA), a cellular phone, or an internet-enabled mobile phone.

11. The system of claim 1, wherein sensor is configured to have a stabilized output in less than about 5 minutes after application of a powered current measuring circuit to the sensor.

12. The system of claim 1, wherein sensor is configured to have a stabilized output in less than about 1 minute after application of a powered current measuring circuit to the sensor.

13. The system of claim 1, wherein sensor is configured to have a stabilized output in less than about 10 seconds after application of a powered measuring circuit to the sensor.

14. The system of claim 1, wherein the analyte sensor assembly further comprises a data storage unit in communication with the data processing unit, wherein the data storage unit is configured to store sensor generated signals for a period of time.

15. The system of claim 1, wherein the analyte-responsive enzyme is a glucose-responsive enzyme.

16. The system of claim 1, wherein the working electrode further comprises a redox mediator covalently or ionically associated with a polymeric moiety.

17. The system of claim 16, wherein the analyte responsive enzyme is covalently or ionically associated with the polymeric moiety.

18. The system of claim 16, wherein the redox mediator comprises a transition metal complex, ferricyanide, phenanthroline quinone, or ferrocene.

19. The system of claim 1, wherein the working electrode is configured and arranged for electrooxidizing a primary reactant in the presence of the enzyme and the counter electrode is configured for electroreducing a secondary reactant.

20. The system of claim 1, wherein the working electrode is configured and arranged for electroreducing a primary reactant in the presence of the enzyme and the counter electrode is configured for electrooxidizing a secondary reactant.

21. The system of claim 1, wherein the R value is such that the potential drop across the resistor, at an analyte concentration at the top of its physically relevant range, is less than 75% of the open circuit potential.

22. The system of claim 1, wherein the R value is less than 40 MΩ

, less than 20 MΩ

, less than 10 MΩ

, or less than 1 MΩ

.

23. The system of claim 1, wherein the primary reactant is glucose.

24. The system of claim 1, wherein the secondary reactant is oxygen.

25. The system of claim 1, wherein the counter electrode comprises a redox mediator covalently or ionically associated with a polymeric moiety.

26. The system of claim 25, wherein the counter electrode further comprises enzyme covalently or ionically associated with the polymeric moiety.

27. The system of claim 1, wherein the counter electrode comprises platinum.

28. The system of claim 1, wherein the counter electrode comprises platinum wire, platinum black, platinum ink, or platinum impregnated carbon.

29. A method for intermittently monitoring a level of an analyte, the method comprising:

positioning an analyte sensor assembly onto skin of a patient, wherein the analyte sensor assembly comprises;

a self-powered electrochemical analyte sensor comprising;

a working electrode comprising an analyte-responsive enzyme disposed on the working electrode, wherein the working electrode is configured and arranged for electrooxidizing or electroreducing a primary reactant in the presence of the analyte-responsive enzyme;

a counter electrode capable of electroreducing or electrooxidizing a secondary reactant; and

a resistor disposed between the working electrode and counter electrode, wherein the resistor comprises an R value,

wherein the self-powered electrochemical analyte sensor maintains a current output directly proportional to analyte concentration in the absence of a reference voltage,

wherein the R value is chosen from within a range of R values for which the current output is independent of the R value at an analyte concentration at the top of its physically relevant range; and

a data processing unit in communication with the self-powered electrochemical analyte sensor; and

a first wireless communication unit in communication with the data processing unit; and

collecting data regarding a level of an analyte from the analyte sensor assembly by positioning a handheld device in close proximity to the analyte sensor assembly, wherein the handheld device comprises a second wireless communication unit,

wherein the analyte sensor assembly is configured for intermittent interrogation by the handheld device via the first wireless communication unit and the second wireless communication unit only upon positioning of the handheld device in close proximity to the analyte sensor assembly by the subject.

30. The method of claim 29, further comprising displaying an indication of the level of the analyte on a display of the handheld device.

31. The method of claim 29, further comprising activating an alarm if the data indicates an alarm condition.

32. The method of claim 29, wherein the analyte sensor assembly further comprises a data storage unit in communication with the data processing unit, and wherein the data storage unit is configured to store sensor generated signals for a period of time.

33. The method of claim 29, further comprising obtaining a calibration value from a calibration device to calibrate the data.

34. The method of claim 29, wherein the sensor is coupled to a radio-frequency powered current measuring circuit.

35. The method of claim 34, wherein the radio-frequency powered current measuring circuit is intermittently powered.

36. The method of claim 29, wherein the sensor is coupled to an inductively powered current measuring circuit.

37. The method of claim 36, wherein the inductively powered current measuring circuit is intermittently powered.

38. The method of claim 29, wherein the sensor is a glucose sensor.

39. The method of claim 29, wherein the first wireless communication unit comprises a first radio-frequency communication protocol.

40. The method of claim 39, wherein the first radio frequency communication protocol is a first RFID communication protocol.

41. The method of claim 39, wherein the second radio frequency communication protocol is a second RFID communication protocol.

42. The method of claim 29, wherein the second wireless communication unit comprises a second radio-frequency communication protocol.

43. The method of claim 29, wherein sensor is configured to have a stabilized output in less than about 5 minutes after application of a powered measuring circuit to the sensor.

44. The method of claim 29, wherein sensor is configured to have a stabilized output in less than about 1 minute after application of a powered measuring circuit to the sensor.

45. The method of claim 29, wherein sensor is configured to have a stabilized output in less than about 10 seconds after application of a powered measuring circuit to the sensor.

46. The method of claim 29, wherein the working electrode is configured and arranged for electrooxidizing a primary reactant in the presence of the enzyme and the counter electrode is configured for electroreducing a secondary reactant.

47. The method of claim 29, wherein the working electrode is configured and arranged for electroreducing a primary reactant in the presence of the enzyme and the counter electrode is configured for electrooxidizing a secondary reactant.

48. The method of claim 29, wherein the R value is such that the potential drop across the resistor, at an analyte concentration at the top of its physically relevant range, is less than 75% of the open circuit potential.

49. The method of claim 29, wherein the R value is less than 40 MΩ

, less than 20 MΩ

, less than 10 MΩ

, or less than 1 MΩ

.

50. The method of claim 29, wherein the primary reactant is glucose.

51. The method of claim 29, wherein the secondary reactant is oxygen.

52. The method of claim 29, wherein the counter electrode comprises a redox mediator covalently or ionically associated with a polymeric moiety.

53. The method of claim 52, wherein the counter electrode further comprises enzyme covalently or ionically associated with the polymeric moiety.

54. The method of claim 29, wherein the counter electrode comprises platinum.

55. The method of claim 29, wherein the counter electrode comprises platinum wire, platinum black, platinum ink, or platinum impregnated carbon.