Analyte monitoring devices

Patent metadata

Field	Value
Publication number	US-9232916-B2
Application number	US-201514595147-A
Country	US
Kind code	B2
Filing date	Jan 12, 2015
Priority date	May 15, 2001
Publication date	Jan 12, 2016
Grant date	Jan 12, 2016

Abstract

Novel membranes comprising various polymers containing heterocyclic nitrogen groups are described. These membranes are usefully employed in electrochemical sensors, such as amperometric biosensors. More particularly, these membranes effectively regulate a flux of analyte to a measurement electrode in an electrochemical sensor, thereby improving the functioning of the electrochemical sensor over a significant range of analyte concentrations. Electrochemical sensors equipped with such membranes are also described.

First claim

What is claimed is:

1. An electrochemical sensor, comprising:
a substrate having a first surface and a second surface, a distal end and a proximal end, the distal end of the substrate for transcutaneous positioning through a skin surface in fluid contact with interstitial fluid under the skin surface;
a working electrode disposed on the first surface of the substrate;
a sensing layer disposed on the working electrode, the sensing layer positioned on the distal end of the substrate; and
a membrane layer disposed on the substrate to limit flux of analyte to the sensing layer on the working electrode and providing a linear response over a range of analyte concentrations;
wherein the sensing layer comprises of crosslinked glucose oxidase, and a low potential polymeric osmium complex mediator.

2. The sensor of claim 1 , wherein the membrane layer encapsulates the sensing layer and the working electrode disposed on the substrate.

3. The sensor of claim 1 , further including a counter electrode disposed on the second surface of the substrate, wherein the membrane layer encapsulates the counter electrode.

4. The sensor of claim 1 , wherein the distal end of the substrate is coated with a membrane solution to dispose the membrane layer on the substrate.

5. The sensor of claim 4 , wherein the distal end of the substrate is dipped in the membrane solution.

6. The sensor of claim 1 , wherein the analyte is glucose.

7. The sensor of claim 1 , wherein the analyte is lactate.

8. The sensor of claim 1 , wherein output current from the sensor measured having a signal decay rate of about 0.06% nA per hour.

9. The sensor of claim 1 , wherein the sensor is linearly responsive over a range of analyte concentration from zero to about 30 mM.

10. An electrochemical sensor, comprising:
a substrate having a first surface and a second surface, a distal end and a proximal end, the distal end of the substrate for transcutaneous positioning through a skin surface in fluid contact with interstitial fluid under the skin surface;
a working electrode disposed on the first surface of the substrate;
a counter electrode disposed on the second surface of the substrate;
a sensing layer disposed on the working electrode, the sensing layer positioned on the distal end of the substrate; and
a membrane layer disposed on the substrate to limit flux of analyte to the sensing layer on the working electrode and providing a linear response over a range of analyte concentrations from zero to about 30 mM, wherein the membrane layer is disposed over the sensing layer and portions of the working electrode and the counter electrode on the distal end of the substrate;
wherein the sensing layer comprises of crosslinked glucose oxidase, and a low potential polymeric osmium complex mediator.

11. The sensor of claim 10 , wherein the distal end of the substrate is coated with a membrane solution to dispose the membrane layer on the substrate.

12. The sensor of claim 11 , wherein the distal end of the substrate is dipped in the membrane solution.

13. The sensor of claim 10 , wherein the analyte is glucose.

14. The sensor of claim 10 , wherein the analyte is lactate.

15. The sensor of claim 10 , wherein output current from the sensor measured having a signal decay rate of about 0.06% nA per hour.

Assignees

• Abbott Diabetes Care Inc

Inventors

• Mao Fei
• Cho Hyun

Classifications

• A61B5/14865 Primary

  invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors · CPC title

• C12Q1/006

  for glucose · CPC title

• A61B5/6846

  specially adapted to be brought in contact with an internal body part, i.e. invasive · CPC title

• C12Q1/002

  Electrode membranes · CPC title

• A61B5/14546

  for measuring analytes not otherwise provided for, e.g. ions, cytochromes · CPC title