Self-powered analyte sensor

• US 10,004,441 B2
• Filed: 11/14/2016
• Issued: 06/26/2018
• Est. Priority Date: 02/26/2009
• Status: Active Grant

• Current Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories)
• Original Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories)
• Inventors: Feldman, Benjamin J., Liu, Zenghe, Ouyang, Tianmei
• Primary Examiner(s): WEARE, MEREDITH H
• Application Number:
  US15/351,162
• Publication Number:
  US 20170188904A1
• Time in Patent Office: 589 Days
• 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. A method for monitoring a level of an analyte, the method comprising:

electrooxidizing or electroreducing, on a working electrode within an analyte sensor assembly configured to be positioned onto a skin of a patient, a primary reactant in a presence of an analyte-responsive enzyme;

electroreducing or electrooxidizing a secondary reactant on a counter electrode within the analyte sensor assembly; and

maintaining a current directly proportional to an analyte concentration in an absence of any reference voltage, the current being maintained by a resistor disposed between the working electrode and the counter electrode, wherein the resistor has an R value chosen from within a range of R values for which the current is independent of the R value at an analyte concentration at a top of its physically relevant range.

2. The method of claim 1, further comprising processing, in a data processing unit coupled with the analyte sensor assembly, information from the analyte sensor assembly and associated with the analyte concentration.

3. The method of claim 2, further comprising communicating between a first wireless communication unit and the data processing unit, the first wireless communication unit being coupled to the data processing unit.

4. The method of claim 3, further comprising intermittently receiving an interrogation at the analyte sensor assembly from a second wireless communication unit of a handheld device, the interrogation being received at the first wireless communication unit only upon positioning of the handheld device in close proximity to the analyte sensor assembly.

5. The method of claim 4, wherein the first wireless communication unit is configured to communicate through a first radio-frequency communication protocol.

6. The method of claim 5, wherein the first radio frequency communication protocol is a first radio frequency identification (RFID) communication protocol.

7. The method of claim 1, wherein the analyte sensor assembly comprises an analyte sensor including the working electrode, the counter electrode, and the resistor, and further comprises a radio-frequency powered current measuring circuit coupled to the analyte sensor.

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

9. The method of claim 1, wherein the analyte sensor assembly comprises an analyte sensor including the working electrode, the counter electrode, and the resistor, and further comprises an inductively powered current measuring circuit coupled to the analyte sensor.

10. The method of claim 1, further comprising storing data associated with information from the analyte sensor assembly for a period of time.

11. The method of claim 1, wherein the analyte-responsive enzyme is a glucose-responsive enzyme.

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

13. The method of claim 12, wherein the analyte responsive enzyme is covalently or ionically associated with the polymeric moiety.

14. The method of claim 12, wherein the redox mediator comprises a transition metal complex, ferricyanide, phenanthroline quinone, or ferrocene.

15. The method of claim 1, wherein the working electrode is configured to electrooxidize the primary reactant in the presence of the analyte-responsive enzyme and the counter electrode is configured to electroreduce the secondary reactant.

16. The method of claim 1, wherein the working electrode is configured to electroreduce the primary reactant in the presence of the analyte-responsive enzyme and the counter electrode is configured to electrooxidize the secondary reactant.

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

18. The method of claim 1, wherein the primary reactant is glucose.

19. The method of claim 1, wherein the R value is such that a potential drop across the resistor, at the analyte concentration at the top of its physically relevant range, is less than 50% of an open circuit potential.

20. The method of claim 1, wherein the R value is such that a potential drop across the resistor, at the analyte concentration at the top of its physically relevant range, is less than 25% of an open circuit potential.

21. An analyte sensor assembly configured to be positioned onto a skin of a patient and to monitor a level of an analyte, the analyte sensor assembly comprising:

a working electrode configured to electrooxidize or electroreduce a primary reactant in a presence of an analyte-responsive enzyme;

a counter electrode configured to electroreduce or electrooxidize a secondary reactant; and

a resistor connected between the working electrode and the counter electrode, the resistor being configured to maintain a current directly proportional to an analyte concentration in an absence of any reference voltage, wherein the resistor has an R value chosen from within a range of R values for which the current is independent of the R value at an analyte concentration at a top of its physically relevant range.

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

23. The analyte sensor assembly of claim 21, wherein the R value is such that a potential drop across the resistor, at the analyte concentration at the top of its physically relevant range, is less than 50% of an open circuit potential.

24. The analyte sensor assembly of claim 21, wherein the R value is such that a potential drop across the resistor, at the analyte concentration at the top of its physically relevant range, is less than 25% of an open circuit potential.