Analyte Sensor with Insertion Monitor, and Methods

• US 20080283396A1
• Filed: 10/31/2007
• Published: 11/20/2008
• Est. Priority Date: 11/04/1999
• Status: Active Grant

• Current Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Inventors: Wang, Yi, Karinka, Shridhara Alva, Vivolo, Joseph A.
• Granted Patent: US 8,066,858 B2
• Time in Patent Office: Days
• US Class Current: 204/403.01
• 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: Y10S 439/909 Medical use or attached to human body

Abstract

A sensor, and methods of making, for determining the concentration of an analyte, such as glucose or lactate, in a biological fluid such as blood or serum, using techniques such as coulometry, amperometry, and potentiometry. The sensor includes a working electrode and a counter electrode, and can include an insertion monitoring trace to determine correct positioning of the sensor in a connector.

Claims

1. A meter for releasable engagement with a sensor, the meter configured to turn on upon contact with an insertion monitor present on a surface of the sensor, and, the meter configured to recognize a calibration code from the insertion monitor.

2. The meter of claim 1 configured to recognize the calibration code based on a shape of the insertion monitor.

3. The meter of claim 1 configured to recognize the calibration code based on a position of the insertion monitor.

4. The meter of claim 1 configured to recognize the calibration code based on an electrical characteristic of the insertion monitor.

5. The meter of claim 4 configured to recognize the calibration code based on a resistance of the insertion monitor.

6. The meter of claim 1 configured to turn on upon contact with an insertion monitor present on an exterior surface of the sensor.

8. The meter of claim 7, wherein the sample is less than about 1 micoliter.

9. A meter for releasable engagement with a sensor, the meter configured to recognize a calibration code from the sensor when the sensor is engaged with the meter.

10. The meter of claim 9, wherein the calibration code is present on a surface of the sensor.

11. The meter of claim 10, wherein the calibration code is present on an exterior surface of the sensor.

12. The meter of claim 10, wherein the calibration code is a pattern.

13. The meter of claim 10, wherein the calibration code is related to an electrical characteristic of the surface of the sensor strip.

14. The meter of claim 13, wherein the calibration code is related to resistance of the surface of the sensor strip.

15. A system for determining the concentration of an analyte in a sample, the system comprising:

an analyte sensor for determining the concentration of an analyte in a sample, the sensor comprising an indicator monitor encoding calibration code; and

a meter configured for electrical connection to the indicator monitor r and to read the calibration code.

16. The system of claim 15, wherein the indicator monitor is a conductive strip on an exterior surface of the sensor.

17. The system of claim 15, wherein the calibration code is based on a resistance of the indicator monitor.

18. The system of claim 17, wherein the indicator monitor comprises carbon and/or silver.

19. The system of claim 15, wherein the calibration code is based on a pattern of conductive areas that form the indicator monitor.

20. The system of claim 15, wherein the sensor further comprises a sample chamber, and the calibration code relates to a volume of the sample chamber.

21. A sensor for determining a concentration of analyte, the sensor comprising:

a first substrate having a first major surface and a second major surface opposing the first major surface;

a second substrate having a first major surface and a second major surface opposing the first major surface, the first and second substrates being disposed so that the first major surface of the first substrate is in facing relationship with the first major surface of the second substrate;

a working electrode disposed on the first major surface of the first substrate;

a counter electrode disposed on the first major surface of one of the first substrate and the second substrate;

a sample chamber having the working electrode and counter electrode present therein;

an insertion monitor on one of the first and the second major surfaces of one of the first substrate and the second substrate, the insertion monitor including a conductive stripe extending across the sensor and the insertion monitor providing encoded calibration information about the sensor.

22. The sensor of claim 21 wherein the sample chamber has a volume of no more than about 1 μ

L.

23. The sensor of claim 21 wherein the sample chamber has a volume of no more than about 0.5 μ

L.