Cationic polymer based wired enzyme formulations for use in analyte sensors

• US 9,885,073 B2
• Filed: 08/29/2016
• Issued: 02/06/2018
• Est. Priority Date: 09/15/2008
• 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., Ouyang, Tianmei, Liu, Zenghe
• Primary Examiner(s): LEONG, SUSAN DANG
• Application Number:
  US15/250,695
• Publication Number:
  US 20170051329A1
• Time in Patent Office: 526 Days
• CPC Class Codes: A61K 38/28 Insulins
• CPC Class Codes: C12Q 1/004 mediator-assisted
• 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: C12Q 1/32 involving dehydrogenase
• CPC Class Codes: G01N 2333/904 acting on CHOH groups as donors, e.g. glucose oxidase, lactate dehydrogenase (1.1)
• CPC Class Codes: G01N 27/3272 Test elements therefor, i.e. disposable laminated substrates with electrodes, reagent and channels optical biosensors G01N33/52
• CPC Class Codes: G01N 27/3273 Devices therefor, e.g. test element readers, circuitry details not specific to biochemical electrodes G01N33/4875

Abstract

Embodiments of the invention include analyte-responsive compositions and electrochemical analyte sensors having a sensing layer that includes an analyte-responsive enzyme and a cationic polymer. Also provided are systems and methods of making the sensors and using the electrochemical analyte sensors in analyte monitoring.

Claims

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

inserting an electrochemical sensor into the skin of a subject, the electrochemical sensor comprising;

a substrate comprising a working electrode and a counter electrode or a counter/reference electrode;

a sensing layer disposed on the working electrode, wherein the sensing layer comprises an analyte-responsive enzyme, a cationic polymer selected from the group consisting of polyallylamine (PAH), polyethyleneimine (PEI), poly(L-lysine) (PLL), or poly(L-arginine) (PLA), and a positively charged redox mediator non-covalently associated with the cationic polymer;

attaching an electrochemical sensor control unit to the electrochemical sensor and the skin of the subject;

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

transmitting the collected data to a display unit using an rf transmitter of the sensor control unit; and

displaying an indication of the level of the analyte on the display of the display unit.

2. The method of claim 1, wherein the analyte is glucose.

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

4. The method of claim 3, wherein the glucose-responsive enzyme is glucose oxidase (GOx).

5. The method of claim 3, wherein the glucose-responsive enzyme is glucose dehydrogenase (GDH).

6. The method of claim 1, wherein the analyte is lactose.

7. The method of claim 1, wherein collecting data comprises generating signals from the sensor and processing the signals into data.

8. The method of claim 1, wherein the data comprises the signals from the sensor.

9. The method of claim 1, further comprising activating an alarm if the data indicates an alarm condition.

10. The method of claim 9, wherein the alarm condition is a level of the analyte exceeds a threshold.

11. The method of claim 10, wherein the threshold is the threshold value for hyperglycemia.

12. The method of claim 10, wherein the threshold is the threshold value for hypoglycemia.

13. The method of claim 9, wherein the alarm condition is a reading indicating a value that is beyond a range of the sensor.

14. The method claim of 13, wherein the range of the sensor is the physiologically relevant measurement range of an analyte.

15. The method of claim 9, wherein the alarm condition is the rate of change in analyte level.

16. The method of claim 15, wherein the rate of change in analyte level reaches a threshold rate of change.

17. The method of claim 15, wherein the rate of change in analyte level exceeds a threshold rate of change.

18. The method of claim 1, further comprising administering a drug in response to the data.

19. The method of claim 18, wherein the drug is insulin.

20. The method of claim 1, further comprising obtaining a calibration value from a calibration device to calibrate the data.

21. The method of claim 20, wherein the calibration device is coupled to the display unit.