Analyte sensors comprising high-boiling point solvents

• US 9,155,499 B2
• Filed: 11/17/2014
• Issued: 10/13/2015
• Est. Priority Date: 11/24/2009
• Status: Active Grant

• Current Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Inventors: Bommakanti, Balasubrahmanya S., Sandhu, Gary, Hoss, Udo, McGarraugh, Geoffrey V.
• Primary Examiner(s): Kaur, Gurpreet
• Application Number:
  US14/543,592
• Publication Number:
  US 20150065833A1
• Time in Patent Office: 330 Days
• US Class Current: 1/1
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• 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 5/6847 mounted on an invasive device
• 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: A61K 38/28 Insulins
• CPC Class Codes: C12Q 1/004 mediator-assisted
• CPC Class Codes: C12Q 1/006 for glucose
• CPC Class Codes: G01N 27/3271 Amperometric enzyme electrodes for analytes in body fluids, e.g. glucose in blood amperometry per se G01N27/49; aspects concerning the enzyme reagent C12Q1/001
• CPC Class Codes: G01N 27/3272 Test elements therefor, i.e. disposable laminated substrates with electrodes, reagent and channels optical biosensors G01N33/52

Abstract

Generally, embodiments of the present disclosure relate to analyte determining methods and devices (e.g., electrochemical analyte monitoring systems) that have improved uniformity of distribution of the sensing layer by inclusion of a high-boiling point solvent, where the sensing layer is disposed proximate to a working electrode of in vivo and/or in vitro analyte sensors, e.g., continuous and/or automatic in vivo monitoring using analyte sensors and/or test strips. 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 using an analyte monitoring system, the method comprising:

inserting at least a portion of an analyte sensor of an analyte sensor control unit into skin of a patient, wherein the analyte sensor comprises;

a working electrode;

a counter electrode; and

a sensing layer disposed proximate to the working electrode, wherein the sensing layer comprises polymer, enzyme, and a high-boiling point solvent at a concentration of 1% to 5% (w/v) of the total formulation of the sensing layer,

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

transmitting the collected data from the analyte sensor control unit to a receiver unit.

2. The method of claim 1, wherein the sensing layer has a arcuate profile as measured using a profilometer.

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

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

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

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

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

8. The method of claim 7, wherein the drug is insulin.

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

10. The method of claim 9, wherein the calibration device is coupled to a display unit.

11. The method of claim 10, further comprising transmitting the calibration value from a transmitter in the display unit to a receiver in the analyte sensor control unit.

12. The method of claim 1, further comprising contacting the sensing layer with a membrane, wherein the membrane is disposed over the sensing layer.

13. The method of claim 1, wherein the high-boiling point solvent comprises a bivalent alcohol, a bivalent alcohol alkyl ether, a bivalent alcohol dialkyl ether, or a polar aprotic solvent.

14. The method of claim 1, wherein the high-boiling point solvent is ethylene glycol, diethylene glycol monomethyl ether, diethylene glycol dimethyl ether, or dimethyl sulfoxide.

15. The method of claim 1, wherein the high-boiling point solvent comprises ethylene glycol.

16. The method of claim 1, wherein the high-boiling point solvent comprises dimethyl sulfoxide.

17. The method of claim 1, wherein the high-boiling point solvent comprises diethylene glycol monomethyl ether.

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

19. The method of claim 18, wherein the sensing layer further comprises a redox mediator.

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

21. The method of claim 19, wherein the redox mediator is covalently bonded to the polymer.