Heterocyclic nitrogen containing polymer coated analyte monitoring device and methods of use

• US 9,096,881 B2
• Filed: 08/19/2014
• Issued: 08/04/2015
• Est. Priority Date: 01/31/2007
• 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, Cho, Hyun
• Primary Examiner(s): DIETERLE, JENNIFER M
• Application Number:
  US14/463,453
• Publication Number:
  US 20150038410A1
• Time in Patent Office: 350 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 5/14865 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 5/6849 in combination with a needle set
• CPC Class Codes: A61K 38/28 Insulins
• CPC Class Codes: C12Q 1/001 Enzyme electrodes
• 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
• CPC Class Codes: G01N 27/3335 the membrane containing at least one organic component G01N27/3271 takes precedence; aspects concerning the enzyme reagent in enzyme electrodes C12Q1/001

Abstract

The present invention is directed to membranes composed of heterocyclic nitrogen groups, such as vinylpyridine and to electrochemical sensors equipped with such membranes. The membranes are useful in limiting the diffusion of an analyte to a working electrode in an electrochemical sensor so that the sensor does not saturate and/or remains linearly responsive over a large range of analyte concentrations. Electrochemical sensors equipped with membranes described herein demonstrate considerable sensitivity and stability, and a large signal-to-noise ratio, in a variety of conditions.

Claims

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

positioning at least a portion of an analyte sensor into skin of a subject, wherein the analyte sensor comprises;

a working electrode comprising;

a sensing layer in contact with the working electrode;

a diffusion limiting membrane layer disposed over the sensing layer, wherein the diffusion limiting membrane layer comprises a crosslinker and a polymer having the formula;

2. The method of claim 1, wherein the sensing layer of the working electrode comprises a glucose-responsive enzyme.

3. The method of claim 1, wherein the sensing layer of the working electrode comprises a redox mediator.

4. The method of claim 3, wherein the redox mediator comprises a complex selected from the group consisting of a ruthenium-containing complex and an osmium-containing complex.

5. The method of claim 3, wherein the redox mediator is non-leachable with respect to the working electrode.

6. The method of claim 3, wherein the redox mediator is immobilized on the working electrode.

7. The method of claim 1, wherein the crosslinker comprises a poly(ethylene glycol).

8. The method of claim 7, wherein the poly(ethylene glycol) is a poly(ethylene glycol)diglycidyl ether.

9. The method of claim 1, wherein the diffusion limiting membrane layer limits flux of glucose or lactate thereacross.

10. The method of claim 1, wherein the diffusion limiting membrane layer limits flux of glucose or lactose thereacross in vivo.

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

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

13. The method of claim 12, wherein the drug is insulin.

14. The method of claim 1, wherein the method further comprises processing the signals into data.

15. The method of claim 13, further comprising obtaining a calibration value from a calibration device to calibrate the data.

16. The method of claim 15, wherein the calibration device is coupled to the display unit.

17. The method of claim 16, further comprising transmitting the calibration value from a transmitter in the display unit to a receiver in the sensor control unit.