Automated system for continuously and automatically calibrating electrochemical sensors

• US 7,022,219 B2
• Filed: 08/22/2002
• Issued: 04/04/2006
• Est. Priority Date: 08/22/2001
• Status: Expired due to Term

• Current Assignee: Instrumentation Lab Co (Instrumentation Lab)
• Original Assignee: Instrumentation Lab Co (Instrumentation Lab)
• Inventors: Fallon, Kevin, Mansouri, Sohrab, Eames, Patti
• Primary Examiner(s): NOGUEROLA, ALEXANDER STEPHAN
• Application Number:
  US10/227,618
• Publication Number:
  US 20030062262A1
• Time in Patent Office: 1,321 Days
• Field of Search: 204/401, 204/403, 204406-409, 204/411, 204/412, 204/433, 436/8, 436 14- 16, 436/18, 436/52, 436/55, 436/66, 436/68, 422/68.1, 422/81, 422/62, 422/82.01, 422/82.02, 422/105, 422/108, 600/373, 205/778, 205/775, 205/792, 604/93.01
• US Class Current: 205/792
• 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 automatic monitoring of a sensor comprising:

(i) analyzing an analyte comprising a known concentration in a reference solution to determine a first measurement of said known concentration of the analyte in said reference solution;

(ii) analyzing said analyte in said reference solution to determine a second measurement of said known concentration of said analyte in said reference solution;

(iii) comparing said known concentration and said first measurement of said analyte;

(iv) comparing said known concentration and said second measurement of said analyte;

(v) comparing said first measurement and said second measurement of said analyte; and

(vi) initiating corrective action if said first measurement of said analyte is substantially similar to said second measurement of said analyte and said first and said second measurements are substantially dissimilar to said known concentration of said analyte.

2. The method of claim 1, wherein said corrective action comprises calibrating said sensor according to said known concentration of said analyte of said reference solution.

3. The method of claim 1, wherein said corrective action comprises rinsing said sensor.

4. The method of claim 1 further comprising the step of providing a sensor system having at least one sensor.

5. The method of claim 4, wherein said sensor system further comprises a sample flow channel disposed adjacent to said sensor.

6. The method of claim 1 wherein the sensor is an electrochemical sensor.

7. The method of claim 1 wherein said reference solution comprises an internal reference solution.

8. The method of claim 7, wherein said sensor is provided in a said cartridge.

9. A method for measuring an analyte in a patient fluid sample comprising automatic monitoring of a sensor system for measuring the analyte concentration in the patient fluid sample, comprising:

(i) analyzing an analyte comprising a known concentration in a reference solution to determine a first measurement of said known concentration of said analyte;

(ii) analyzing said analyte in said reference solution to determine a second measurement of said known concentration of said analyte;

(iii) comparing said known concentration and said first measurement of said analyte;

(iv) comparing said known concentration and said second measurement of said analyte;

(v) comparing said first measurement of said analyte and said second measurement of said analyte; and

(vi) measuring said analyte concentration in said patient fluid sample if said first measurement of said analyte and said second measurement of said analyte are sufficiently dissimilar and said second measurement is sufficiently similar to said known concentration of said reference solution.

10. The method of claim 9 further comprising providing a sensor system having at least one sensor.

11. The method of claim 9 wherein said reference solution comprises an internal reference solution.

12. The method of claim 11 further comprising providing said internal reference solution in a disposable cartridge.

13. The method of claim 9 wherein step (iv) comprises analyzing a blood glucose level of a blood sample.

14. The method of claim 13 further comprising receiving the blood sample from a blood glucose test strip.

15. The method of claim 9 wherein step (iv) comprises analyzing blood urea nitrogen (BUN) concentration of a blood sample.

16. A sensor system comprising:

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

(b) a sensor analyzing said analyte to determine a first measurement and a second measurement of said analyte in said reference solution;

(c) a comparator comparing;

(i) said known concentration and said first measurement;

(ii) said known concentration and said second measurement; and

(iii) said first measurement and said second measurement; and

(d) a corrective action device initiating corrective action if said first measurement of said analyte in said reference solution is substantially similar to said second measurement of said analyte in said reference solution and said first and said second measurements are substantially dissimilar to said known concentration of said analyte in said reference solution.

17. The sensor system of claim 16 further comprising a cartridge for holding said internal reference solution.

18. The sensor system of claim 16 further comprising a microprocessor to perform at least one of measurement, calculation, storage, and control functions relating to at least one of said analyte and said measurements of said analyte.

19. The sensor system of claim 18, wherein said microprocessor comprises said corrective action device.

20. The sensor system of claim 16 further comprising a rinser to rinse said sensor.

21. The sensor system or claim 16 wherein the sensor is an electrochemical sensor.

22. A sensor system comprising:

(i) means for analyzing an analyte comprising a known concentration in a reference solution to determine a first measurement of said analyte in said reference solution;

(ii) means for analyzing said analyte in said reference solution to determine a second measurement of said analyte in said reference solution;

(iii) means for comparing said first measurement of said analyte and said second measurement of said analyte in said reference solution;

(iv) means for comparing said first measurement of said analyte and said known concentration of said analyte;

(v) means for comparing said second measurement of said analyte and said known concentration of said analyte; and

(vi) means for initiating corrective action if said first measurement of said analyte is substantially similar to said second measurement of said analyte and said first and said second measurements are substantially dissimilar to said known concentration of said analyte in said internal reference solution.

23. A method for monitoring performance of a sensor for analyzing at least a first and a second patient sample during use life of the sensor, the method comprising the steps of:

(a) verifying the sensor performance during the use life of the sensor only once with an external solution before analyzing the a first patient sample; and

thereafter

(b) verifying the sensor performance before analyzing the second patient sample using only an internal reference solution to monitor the sensor performance.

24. The method according to claim 23 further comprising in step (a):

(i) initially calibrating the sensor using the internal reference solution; and

(ii) verifying the sensor performance using the external solution.

25. The method according to claim 23 further comprising in step (b):

(i) determining a first measurement by the sensor of a known concentration of an analyte in the internal reference solution;

(ii) determining a second measurement by the sensor of the known concentration of the analyte in the internal reference solution; and

(iii) comparing the known concentration, the first measurement of the analyte, and the second measurement of the analyte to determine sensor performance.

26. The method according to claim 25 further comprising:

(iv) initiating corrective action if the first measurement of the analyte is substantially similar to the second measurement of the analyte and the first and the second measurements are substantially dissimilar to the known concentration of the analyte.

27. The method according to claim 25 further comprising:

(iv) recalibrating the sensor if the first measurement of the analyte is substantially similar to the second measurement of the analyte and the first and the second measurements are substantially dissimilar to the known concentration of the analyte.

28. The method according to claim 25 wherein the sensor is acceptable for analyzing the first sample if the second measurement is dissimilar to the first measurement and the second measurement is substantially similar to the known concentration of the analyte.

29. The method according to claim 25 further comprising:

(iv) recalibrating the sensor with 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.

30. The method according to claim 25 further comprising:

(iv) recalibrating the sensor with the 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.

31. The method according to claim 23 further comprising:

(c) recalibrating the sensor with the internal reference solution if the sensor performance in step (a) or the sensor performance in step (b) is outside a preset range of acceptable sensor performance.

32. The method according to claim 23 further comprising:

(c) initiating corrective action if the sensor performance in step (a) or the sensor performance in step (b) is outside a preset range of acceptable sensor performance.

33. The method according to claim 23 wherein the sensor is an electrochemical sensor.

34. The method according to claim 23 wherein the sensor performance comprises accuracy of the sensor measurement.