Automated system for continuously and automatically calibrating electrochemical sensors

• US 8,721,852 B2
• Filed: 12/27/2011
• Issued: 05/13/2014
• Est. Priority Date: 08/22/2001
• Status: Expired due to Fees

• Current Assignee: Instrumentation Lab Co (Instrumentation Lab)
• Original Assignee: Instrumentation Lab Co (Instrumentation Lab)
• Inventors: Mansouri, Sohrab, Fallon, Kevin, Eames, Patti
• Primary Examiner(s): Van, Luan
• Assistant Examiner(s): Kaur, Gurpreet
• Application Number:
  US13/337,561
• Publication Number:
  US 20120090993A1
• Time in Patent Office: 868 Days
• Field of Search: 205/775, 205/783, 205/78.5, 204/415, 204/433, 204/403.03, 204/409, 436/9, 436/11, 436/8, 436/52, 436/53, 422/67, 422/81, 422/82, 422/52
• US Class Current: 204/403.03
• 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 blood chemistry analysis system, comprising:

(a) one or more sensors in a sensor assembly for performing a first measurement and a second measurement of an analyte in at least one internal reference solution, said internal reference solution comprising a known concentration of said analyte;

(b) a storage element operably coupled to the one or more sensors for storing;

(i) data representing the first measurement of concentration of the analyte in the reference solution, and

(ii) data representing the second measurement of concentration of the analyte in the reference solution;

(c) a microprocessor, operably coupled to the storage element and microprocessor programmed to compare said data representing;

(i) said known concentration of the analyte and said first measurement,

(ii) said known concentration and said second measurement,

(iii) said first measurement and said second measurement, and to store said compare data representing said first measurement that is similar to data representing said second measurement, and said data representing said first measurement and said data representing said second measurement are dissimilar to said known concentration of said analyte in said reference solution, wherein said concentration data is stored in said storage element; and

(d) a correction action device in communication with said sensors and reactive to signal from said microprocessors for taking a corrective action when said compare data is stored in said storage element.

2. The system of claim 1 wherein the corrective action device comprises a means for calibrating said one or more sensors.

3. The system of claim 1 wherein said corrective action device comprises a corrective action protocol.

4. The system of claim 3 wherein said corrective action protocol comprises executing an action to disable said one or more sensors.

5. The system of claim 1 wherein the corrective action device comprises a rinser for said one or more of the sensors.

6. The system of claim 1 further comprising a waste container and a flow line, wherein said at least one internal reference solution and said waste container are connected to said sensor assembly by a flow line.

7. The system of claim 1 further comprising a pump wherein said pump pumps said internal reference solution into the sensor assembly through a line.

8. The system of claim 7 wherein said pump pumps a patient sample into the sensor assembly through a line.

9. The system of claim 8 wherein said sample is blood.

10. The system of claim 1 wherein said one or more sensors is a working electrode.

11. The system of claim 1 wherein said one or more sensors is an indicator electrode.

12. The system of claim 1 wherein said one or more sensors is a reference electrode.

13. The system of claim 1 wherein said one or more sensors is a counter electrode.

14. The system of claim 1 further comprising a corrective action report.

15. The system of claim 14 wherein said corrective action report comprises a list of corrective actions taken.

16. The system of claim 1 wherein said corrective action is selected from the group consisting of a means for recalibrating using one or more internal reference solutions, a means for determining that the cartridge is unavailable thr sampling, an alert for a user of the sensor of a failure pattern, a mechanism to initiate calibration, or to adjust an output of the sensor, or to check fluidics, and a means to repeat a test.

17. The system of claim 1 further comprising a pump wherein said pump is in fluid communication with the one or more sensors and reactive to signals from said microprocessor for rinsing said sensors.

18. A sensor system comprising:

(a) a reference solution comprising a known concentration of at least one analyte;

(b) a sensor responsive to a concentration of the at least one analyte in the reference solution;

(c) a memory operably coupled to the sensor for storing;

(i) data representing the known concentration of the analyte in the reference solution,

(ii) data representing a first measurement of concentration of the analyte in the reference solution, and

(iii) data representing a second measurement of concentration of the analyte in the reference solution;

(d) a comparator operably coupled to the memory and configured for comparing;

(i) the data representing the known concentration and the data representing the first measurement;

(ii) the data representing the known concentration and the data representing second measurement; and

(iii) the data representing the first measurement and the data representing the second measurement; and

(e) a corrective action device programmed to initiate a corrective action if the data representing the first measurement and the data representing the second measurement are similar to each other but both dissimilar to the data representing known concentration of said analyte in said reference solution.

19. The sensor system of claim 18 wherein the corrective action device for initiating said corrective action comprises a microprocessor.

20. The sensor system of claim 18 wherein the sensor is an electrochemical sensor.