Automated system for continuously and automatically calibrating electrochemical sensors

• US 8,128,801 B2
• Filed: 10/27/2005
• Issued: 03/06/2012
• Est. Priority Date: 08/22/2001
• Status: Active Grant

• Current Assignee: Instrumentation Lab Co (Instrumentation Lab)
• Original Assignee: Instrumentation Lab Co (Instrumentation Lab)
• Inventors: Mansouri, Sohrab, Fallon, Kevin, Eames, Patti
• Primary Examiner(s): Noguerola, Alex
• Assistant Examiner(s): Kaur, Gurpreet
• Application Number:
  US11/259,932
• Publication Number:
  US 20060042964A1
• Time in Patent Office: 2,322 Days
• Field of Search: 205/775, 205/783, 205/787.5, 204/415, 204/433, 436/9, 436/11, 436/8, 436/52, 436/53, 422/67, 422/81, 422/82, 422/52, 600/308, 73/10.2
• US Class Current: 205/775
• CPC Class Codes: A61B 2560/0223 of calibration, e.g. protocols for calibrating sensors
• CPC Class Codes: A61B 5/14535 for measuring haematocrit
• CPC Class Codes: A61B 5/14539 for measuring pH
• CPC Class Codes: A61B 5/14542 for measuring blood gases A61B5/14551 takes precedence
• CPC Class Codes: A61B 5/1477 non-invasive
• CPC Class Codes: A61B 5/1486 using enzyme electrodes, e.g. with immobilised oxidase
• CPC Class Codes: G01N 27/38 Cleaning of electrodes
• CPC Class Codes: G01N 33/492 Determining multiple analytes
• CPC Class Codes: Y10T 436/10 Composition for standardization, calibration, simulation, stabilization, preparation or preservation; processes of use in preparation for chemical testing

Abstract

An electrochemical sensor system that continuously monitors and calibrates the sensors included in the system. The invention also includes a method for determining failure patterns of a sensor and incorporating into an electrochemical sensor system the ability to recognize the failure pattern and initiate remedial action.

Claims

1. A method for monitoring sensor system performance for in vitro diagnostic testing of patient samples, comprising:

(a) providing a plurality of sensors and one or more internal reference solutions in a replaceable cartridge for use in a sensor system, said internal reference solutions comprising a plurality of analytes each having a known concentration;

(b) determining a first response of one sensor of the plurality of sensors to one of the plurality of analytes in a first internal reference solution in between testing of patient samples;

(c) determining a second response of the one sensor of the plurality of sensors to the one of the plurality of analytes in the first internal reference solution;

(d) taking action in response to the determining in steps (b) and (c) to provide continued testing of patient samples by initiating a cleaning cycle if the first response to the analyte in step (b) is substantially similar to the second response to the analyte in step (c) and the first and the second responses are substantially dissimilar to the response of the sensor to the known concentration of the analyte;

(e) optionally signaling for replacement of said cartridge when the action of step (d) fails to provide continued testing of patient samples.

2. The method of claim 1 wherein the action further comprises calibration of the one sensor of the plurality of sensors using the first or another internal reference solution.

3. The method of claim 1 wherein at least one of the plurality of sensors comprises an electrochemical sensor.

4. The method of claim 1 wherein the action of step (d) further comprises a corrective action comprising providing a rinsing solution before step (e) if the action in step (d) fails to provide continued patient testing.

5. The method of claim 1 wherein the action of step (d) responds to an error in at least one of slope and drift.

6. The method of claim 1 wherein the action of step (d) responds to at least one of a blood clot and an interference.

13. The method of claim 1 wherein step (b) occurs immediately before each patient sample.

14. The method of claim 1, further comprising providing a rinsing solution in the replaceable cartridge.

7. A method for monitoring performance of a sensor for analyzing patient fluid samples during the use life of the sensor, the method comprising:

(i) containing the sensor and a first and another internal reference solutions in a replaceable cartridge;

(ii) verifying the sensor performance during the use life of the sensor in between analysis of patient fluid samples using the first internal reference solution to evaluate the sensor performance;

(iii) automatically verifying the sensor performance using said first or another internal reference solution in the event of a failure to verify in step (ii), comprising

(a) determining a first measurement by the sensor of a known concentration of an analyte in said first or another internal reference solution,

(b) determining a second measurement by the sensor of the known concentration of the analyte in said reference solution in which a measurement was determined in step (a),

(c) taking action based on the determined measurements of steps (a) and (b), to provide continued testing on patient fluid samples, and

(d) signaling for replacement of said cartridge when taking action in step (c) fails to provide continued testing on patient fluid samples;

(iv) verifying the sensor performance before analyzing a patient fluid sample and thereafter verifying the sensor performance according to steps (ii) and (iii); and

,

(v) accepting the sensor for analysis of patient fluid samples if the second measurement is dissimilar to the first measurement and the second measurement is substantially similar to the known concentration of the analyte.

8. The method according to claim 7 wherein the action of step (c) comprises recalibrating the sensor with an internal reference solution if the sensor performance in step (iii) is outside a preset range of acceptable sensor performance.

9. The method according to claim 7 wherein the action of step (c) comprises recalibrating the sensor with the first internal reference solution if the first measurement and the second measurement are substantially dissimilar and the first measurement is substantially similar to the known concentration of the analyte.

10. The method according to claim 7 wherein the action of step (c) comprises recalibrating the sensor with the first or another internal reference solution if the first measurement is substantially dissimilar to the second measurement and the first and the second measurements are substantially dissimilar to the known concentration of the analyte.

11. The method according to claim 7 wherein the sensor is an electrochemical sensor.

12. The method according to claim 7 wherein the sensor performance comprises accuracy of the sensor measurement.