Analyte sensors comprising hydrogel membranes

• US 9,668,685 B2
• Filed: 05/22/2015
• Issued: 06/06/2017
• 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: Hoss, Udo, Bommakanti, Balasubrahmanya S., Sandhu, Gary
• Primary Examiner(s): JANG, CHRISTIAN YONGKYUN
• Application Number:
  US14/719,820
• Publication Number:
  US 20150250412A1
• Time in Patent Office: 746 Days
• CPC Class Codes: A61B 5/0004 characterised by the type of physiological signal transmitted
• CPC Class Codes: A61B 5/145 Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissuemeasuring of blood pressure or blood flow A61B5/02; non-radiation detecting or locating of foreign bodies in blood A61B5/06
• 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 5/1486 using enzyme electrodes, e.g. with immobilised oxidase
• 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 5/742 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

Abstract

Generally, embodiments of the present disclosure relate to analyte determining methods and devices (e.g., electrochemical analyte monitoring systems) that have improved signal response and stability by inclusion of a coating including a hydrogel, a crosslinker, and a swelling modulator, where the coating 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, the method comprising:

inserting an electrochemical sensor into skin of a patient, wherein the electrochemical sensor comprises;

a working electrode comprising a sensing layer disposed thereon;

a membrane disposed over the sensing layer, wherein the membrane comprises a hydrogel, a crosslinker, and a swelling modulator comprising a 3-arm epoxide;

collecting data regarding a level of an analyte from signals generated by the sensor;

transmitting the collected data to a display unit; and

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

2. The method of claim 1, wherein the membrane reduces the absorption of water as compared to a membrane in the absence of the swelling modulator.

3. The method of claim 1, wherein the hydrogel comprises a heterocyclic nitrogen-containing polymer hydrogel.

4. The method of claim 3, wherein the crosslinker comprises a 4-arm polyethylene glycol epoxide.

5. The method of claim 4, wherein the 4-arm polyethylene glycol epoxide has a molecular weight of 1,000 to 20,000 Da.

6. The method of claim 1, wherein the 3-arm epoxide comprises triglycidyl glycerol.

7. The method of claim 1, wherein the hydrogel comprises a self-polymerizing hydrogel.

8. The method of claim 7, wherein the self-polymerizing hydrogel comprises a polyethylene glycol hydrogel or a polyethylene glycol derivative hydrogel.

9. The method of claim 8, wherein the self-polymerizing hydrogel comprises polyethylene glycol triacrylate.

10. The method of claim 7, wherein the crosslinker comprises a 2-arm polyethylene glycol acrylate or a 4-arm polyethylene glycol acrylate.

11. The method of claim 10, wherein the crosslinker has a molecular weight of 1,000 to 20,000 Da.

12. The method of claim 7, wherein the self-polymerizing hydrogel comprises an activating agent and an initiator.

13. The method of claim 12, wherein the activating agent comprises ferrous gluconate.

14. The method of claim 12, wherein the initiator comprises hydrogen peroxide.

15. The method of claim 7, wherein the self-polymerizing hydrogel is adapted to polymerize at room temperature.

16. The method of claim 1, wherein the sensor is a glucose sensor and the sensing layer further comprises a glucose-responsive enzyme.

17. The method of claim 16, wherein the sensing layer comprises a redox mediator.

18. The method of claim 17, wherein the redox mediator comprises a ruthenium-containing complex or an osmium-containing complex.

19. The method of claim 1, wherein the crosslinker is covalently bonded to the swelling modulator.

20. The method of claim 1, wherein the crosslinker has a molecular weight of 1,000 to 20,000 Da and is covalently bonded to the swelling modulator which does not comprise PEG.

21. The method of claim 1, wherein the membrane comprises more than one coating of the hydrogel, crosslinker and swelling modulator.

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

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

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

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

26. The method of claim 25, wherein the drug is insulin.

27. The method of claim 26, further comprising obtaining a calibration value from a calibration device to calibrate the data.

28. The method of claim 27, wherein the calibration device is coupled to the display unit.

29. The method of claim 28, further comprising transmitting the calibration value from a transmitter in the display unit to a receiver in a sensor control unit, wherein the sensor control unit is integrated with the sensor.