Method for monitoring an arrangement for determining the concentration of an analyte in a body fluid

• US 7,949,477 B2
• Filed: 12/23/2008
• Issued: 05/24/2011
• Est. Priority Date: 06/28/2006
• Status: Expired due to Fees

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diagnostics Operations Incorporated (Roche Holding AG)
• Inventors: Rinne, Helmut, Ocvirk, Gregor
• Primary Examiner(s): Tsai; Carol S
• Application Number:
  US12/342,346
• Publication Number:
  US 20090157330A1
• Time in Patent Office: 882 Days
• Field of Search: 702/22, 702/23, 702/30, 702/31, 702/32, 702/50, 702/45, 702/57, 604/65, 604/66, 604/67, 604/31, 604/6.09, 600/418, 600/419, 600/454, 600/468, 600/465, 600/504, 600/395, 600/396, 600/366, 600/316, 600/365, 210/87, 210/93, 210/739, 210/646, 210/434, 210/321.65, 210/321.72, 210/929
• US Class Current: 702/23
• CPC Class Codes: A61B 5/14528 invasively
• 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: Y10S 210/929 Hemoultrafiltrate volume measurement or control processes

Abstract

The invention relates to a method for monitoring an arrangement for determining a concentration of an analyte in a body fluid. The determination of the concentration of the analyte by means of the arrangement involves a procedure in which the analyte from the body fluid passes through an interface and is transported in a stream of liquid into a flowmeter chamber, in which a measurement is carried out to determine the concentration of the analyte. The evaluation of the measurement takes place in a signal processor. The monitoring of the arrangement comprises the following steps: measurement of measured values of at least two correlated system parameters of the arrangement by means of a sensor system, and comparison of the measured values with limit values stored for each of the system parameters in a storage unit, to obtain a combination of at least two comparison results.

Claims

1. A method for monitoring an arrangement for determining concentration of an analyte in a body fluid, the arrangement having an interface through which the body fluid passes, a flowmeter chamber which receives a stream of the liquid and carries out a measurement to determine concentration of the analyte, and a signal processor which evaluates the measurement, the method comprising the following steps:

using a sensor system to obtain measured values of at least two correlated system parameters of the arrangement;

comparing the measured values with limit values stored for each of the system parameters in a storage unit to obtain at least two comparison results; and

determining with the signal processor whether a malfunction has occurred in the arrangement based upon the at least two comparison results.

2. The method of claim 1, wherein, with defined combinations of comparison results, the signal processor triggers at least one reaction of the arrangement, the at least one reaction being selected from the following group:

displaying a warning or problem report by a display unit of the arrangement, displaying a recalibration prompt by the display unit, displaying by the display unit a prompt to replace a component of the arrangement, switching off of the arrangement, output of an optical, acoustic or haptic alarm signal, regulation of at least one system parameter, influencing the values of a first system parameter by regulating the values of a second system parameter correlated with the first system parameter, and brief modification of a system parameter in order to eliminate a possible system error on account of the combination of the comparison results.

3. The method of claim 1, wherein the sensor system carries out measurements to determine at least two system parameters selected from the following group:

temperature of the stream of liquid, electrical voltage between at least two electrodes along which the stream of liquid flows in the flowmeter chamber, time change of an electric current in relation to a time change of an electrical voltage with reference to at least two electrodes arranged in the flowmeter chamber, system variable of a transport device which is contained in the arrangement and which serves to transport the stream of liquid, battery voltage of at least one battery provided for energy supply in the arrangement, flow rate of the stream of liquid through the flowmeter chamber, and concentration of a marker.

4. The method of claim 1, wherein a countervoltage between a counterelectrode, arranged in the flowmeter chamber, and a working electrode, a temperature of the stream of liquid, and a flow rate of the stream of liquid through the flowmeter chamber, are in each case compared by the signal processor with limit values stored in the storage unit.

5. The method of claim 1, wherein a flow rate of the stream of liquid through the flowmeter chamber, a battery voltage of a battery contained in the arrangement, and a system variable of a transport device contained in the arrangement and used to transport the stream of liquid, are each compared by the signal processor with respective limit values stored in the storage unit.

6. The method of claim 1, wherein the values of at least one system variable measured by the sensor system are taken into account in the determination of the concentration of the analyte.

7. The method of claim 1, wherein the measurement to determine the concentration of the analyte takes place with a defined measurement frequency, and the measurement of the measured values of the at least two correlated system parameters also takes place with the defined measurement frequency.

8. An arrangement for determining a concentration of an analyte in a body fluid, comprising:

an interface for taking an analyte from a body fluid into a stream of perfusion liquid in the arrangement;

a liquid conduit for routing the stream of perfusion liquid from the interface to a flowmeter chamber;

a transport device for transporting the stream of liquid from the interface to the flowmeter chamber;

a detector arrangement located in the flowmeter chamber and used to carry out measurements to determine the concentration of the analyte;

a signal processor for calculating the concentration of the analyte from results of the measurements by the detector arrangement;

a sensor system for obtaining measured values of at least two correlated system parameters;

a storage unit; and

means for comparing the measured values with limit values stored for each of the system parameters in the storage unit, to obtain a combination of at least two comparison results.

9. The arrangement of claim 8, wherein the sensor system comprises at least two sensors selected from the following group:

electrical voltage sensor, electric current sensor, temperature sensor, flow rate sensor, revolution counter and concentration sensor.