In Vivo Analyte Monitor With Malfunction Detection

• US 20090057148A1
• Filed: 08/29/2008
• Published: 03/05/2009
• Est. Priority Date: 09/01/2007
• Status: Active Grant

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diagnostics Operations Incorporated (Roche Holding AG)
• Inventors: Marquant, Michael, Wieder, Herbert
• Granted Patent: US 8,594,760 B2
• Time in Patent Office: Days
• US Class Current: 204/403.10
• CPC Class Codes: A61B 2560/0271 using a remote monitoring unit
• 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

Abstract

The measuring system for in vivo monitoring of an analyte concentration with malfunction detection, comprises an electrode system, a potentiostat and an evaluation unit. The electrode system has a working electrode, a reference electrode, and a counter electrode. The potentiostat is for adjusting a difference of potential between the electric potential of the working electrode and the electric potential of the reference electrode to a specified value and for measuring an electric current flowing between the working electrode and the counter electrode. The potentiostat comprises a working electrode terminal for connection to the working electrode, a reference electrode terminal for connection to the reference electrode, and a counter electrode terminal for connection to the counter electrode. The evaluation unit monitors the electric potential of the counter electrode and generates a malfunction signal when said potential is outside a specified reference range. A method of operation is also disclosed.

Claims

1. Measuring system for in vivo monitoring of an analyte concentration with malfunction detection, comprising:

an electrode system comprising,

a working electrode,

a reference electrode, and

a counter electrode;

a potentiostat for adjusting a difference of potential between the electric potential of the working electrode and the electric potential of the reference electrode to a specified value and for measuring an electric current flowing between the working electrode and the counter electrode, the potentiostat comprising,

a working electrode terminal for connection to the working electrode,

a reference electrode terminal for connection to the reference electrode, and

a counter electrode terminal for connection to the counter electrode;

an evaluation unit which monitors the electric potential of the counter electrode and which generates a malfunction signal when said potential is outside a specified reference range.

2. The measuring system in claim 1 wherein the reference range is specified as a function of the current flowing between the working electrode and the counter electrode.

3. The measuring system in claim 1 wherein the reference range is specified as a function of a former value of the electric potential of the counter electrode.

4. The measuring system as in claim 1 further comprising,

a safety resistor connected between the reference electrode terminal and the counter electrode terminal.

5. The measuring system in claim 1 further comprising,

a switch for decoupling the counter electrode from the counter electrode terminal of the potentiostat.

6. The measuring system in claim 1 further comprising,

a switch for decoupling the working electrode from the working electrode terminal of the potentiostat.

7. The measuring system in claim 1 further comprising,

a testing resistor and at least one switch connected in series with the testing resistor for connecting the working electrode terminal to the counter electrode terminal of the potentiostat via the testing resistor for testing purposes.

8. The measuring system in claim 7 further comprising,

a testing switch for supplying a nominal potential to the counter electrode terminal of the potentiostat for testing purposes.

9. The measuring system in claim 1 further comprising,

a display for displaying measured analyte concentration values, wherein the evaluation unit communicates with the display wirelessly for transmitting to the display the malfunction signal which is produced when the electric voltage between the working electrode and the counter electrode deviates from the reference value by more than the threshold value.

10. A method for detecting malfunctions of a measuring system for in vivo measurement of an analyte concentration, comprising

measuring an electric current flowing between a working electrode and a counter electrode the intensity of which correlates with the analyte concentration to be measured;

monitoring an electric potential of the counter electrode;

decoupling the counter electrode from the potentiostat;

measuring the electric potential then occurring at the working electrode; and

,

detecting malfunctions upon any deviation of the measured potential from a threshold value and the existence of a malfunction is derived when the deviation exceeds a specified threshold value.

11. Measuring system for in vivo monitoring of an analyte concentration with malfunction detection, comprising:

an electrode system comprising,

a working electrode,

a reference electrode, and

a counter electrode;

a potentiostat for adjusting a difference of potential between the electric potential of the working electrode and the electric potential of the reference electrode to a specified value and for measuring an electric current flowing between the working electrode and the counter electrode, the potentiostat comprising,

a working electrode terminal for connection to the working electrode,

a reference electrode terminal for connection to the reference electrode, and

a counter electrode terminal for connection to the counter electrode;

a testing resistor and at least one switch connected in series with the testing resistor for connecting the working electrode terminal to the counter electrode terminal of the potentiostat via the testing resistor for testing purposes;

a testing switch for supplying a nominal potential to the counter electrode terminal of the potentiostat for testing purposes; and

,

an evaluation unit which monitors the electric potential of the counter electrode and which generates a malfunction signal when said potential is outside a specified reference range.

12. Measuring system for in vivo monitoring of an analyte concentration with malfunction detection, comprising:

an electrode system comprising,

a working electrode,

a reference electrode, and

a counter electrode;

a potentiostat for adjusting a difference of potential between the electric potential of the working electrode and the electric potential of the reference electrode to a specified value and for measuring an electric current flowing between the working electrode and the counter electrode, the potentiostat comprising,

a working electrode terminal for connection to the working electrode,

a reference electrode terminal for connection to the reference electrode, and

a counter electrode terminal for connection to the counter electrode;

a testing resistor and at least one switch connected in series with the testing resistor for connecting the working electrode terminal to the counter electrode terminal of the potentiostat via the testing resistor for testing purposes;

a testing switch for supplying a nominal potential to the counter electrode terminal of the potentiostat for testing purposes; and

,

a means for evaluation to monitor the electric potential of the counter electrode and which generates a malfunction signal when said potential is outside a specified reference range.