Method for detecting a malfunction of a sensor for measuring an analyte concentration in vivo

Patent metadata

Field	Value
Publication number	US-10111609-B2
Application number	US-201514954276-A
Country	US
Kind code	B2
Filing date	Nov 30, 2015
Priority date	Oct 5, 2009
Publication date	Oct 30, 2018
Grant date	Oct 30, 2018

Abstract

The invention relates to a method for detecting a malfunction of a sensor for measuring an analyte concentration in vivo, wherein a series of measurement signals is produced by means of the sensor, and a value of a noise parameter is continually determined from the measuring signals, the noise parameter indicating how severely the measurement is impaired by interference signals. According to the invention, continually determined values of the noise parameter are used to determine how quickly the noise parameter changes, and the rate of change of the noise parameter is evaluated to detect a malfunction.

First claim

What is claimed is:

1. A method for detecting a malfunction of a sensor for measuring an analyte concentration in vivo, comprising:
producing a series of measuring signals, by means of the sensor;
determining successively a value of a noise parameter from the measuring signals, the noise parameter indicating how severely the measurement is impaired by interference signals;
determining the rate of change of the values of the noise parameter by calculating a time derivative of the noise parameter, wherein the rate of change of the noise parameter is determined on a smoothened series of values of the noise parameter; and
analyzing the rate of change of the noise parameter in order to detect a malfunction,
wherein in calculating the value of the noise parameter it is determined which portion of a measuring value is based on the interference signals such that a given measuring value is the sum of a useful signal that corresponds to the analyte concentration and the interference signal, and
wherein a recursive filter is used to separate a noise portion from the useful portion of the measurement signal.

2. The method according to claim 1 , wherein one value of a noise parameter each is determined for a pre-determined time interval.

3. The method according to claim 1 , wherein the rate of change of the noise parameter is analyzed by comparing it to a threshold value.

4. The method according to claim 3 , wherein the threshold value is changed during sensor operation as a function of a measuring result.

5. The method according to claim 4 , wherein the sensor comprises a working electrode, a counter-electrode, and a reference electrode, whereby the measuring result is based on a measurement of the electrical potential of the counter-electrode.

6. The method according to claim 1 , wherein a warning signal is generated as a consequence of the detection of a malfunction.

7. The method according to claim 1 , wherein a malfunction that has been determined by the analysis of the rate of change is assigned to one of at least two classes.

8. The method according to claim 7 , wherein the assignment is made as a function of the rate of change and of at least one further parameter.

9. The method according to claim 1 , wherein the noise parameter characterizes the absolute intensity of the interference signals.

10. The method according to claim 1 , wherein multiple measuring signals are used to calculate one measuring value each and multiple measuring values are used to calculate one value of the noise parameter each.

11. The method according to claim 10 , wherein the measuring values are calculated by calculating the mean of multiple measuring signals.

12. The method according to claim 1 , wherein the smoothened series of values of the noise parameter is obtained by calculating a mean of a pre-determined number of consecutive noise parameter values.

Assignees

• Roche Diabetes Care Inc

Inventors

• Schmelzeisen-Redeker Guenther
• Staib Arnulf
• Kloetzer Hans-Martin

Classifications

• A61B5/746

  Alarms related to a physiological condition, e.g. details of setting alarm thresholds or avoiding false alarms · CPC title

• A61B5/725

  using specific filters therefor, e.g. Kalman or adaptive filters (specific diagnostics methods using using bioelectric or biomagnetic signals A61B5/316) · CPC title

• A61B5/1486 Primary

  using enzyme electrodes, e.g. with immobilised oxidase · CPC title

• A61B5/1468

  using chemical or electrochemical methods, e.g. by polarographic means · CPC title

• A61B5/1495 Primary

  Calibrating or testing of in-vivo probes · CPC title