Method and assembly for determining the temperature of a test sensor

• US 8,313,951 B2
• Filed: 12/29/2011
• Issued: 11/20/2012
• Est. Priority Date: 10/15/2007
• Status: Active Grant

• Current Assignee: Ascensia Diabetes Care Holdings AG (PHC Holdings Corporation)
• Original Assignee: Bayer Healthcare LLC (Bayer AG)
• Inventors: Blais, Jeffrey D., Sun, Steve, Harrison, Bern, Parasnis, Narasinha C., Peteu, Serban F., Nguyen, Tony, Ripley, Paul, Wang, Xin, Gofman, Igor
• Primary Examiner(s): Wallenhorst, Maureen
• Application Number:
  US13/339,533
• Publication Number:
  US 20120100625A1
• Time in Patent Office: 327 Days
• Field of Search: 436/63, 436/95, 436/147, 436/164, 422/82.05, 422/82.09, 422/82.12, 435/14, 374/120, 374/121, 374/131, 374/141, 374/142, 600/549
• US Class Current: 436/147
• CPC Class Codes: A61B 2560/0242 adapted to measure environmental factors, e.g. temperature, pollution
• CPC Class Codes: A61B 2560/0252 using ambient temperature
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/1455 using optical sensors, e.g. spectral photometrical oximeters
• CPC Class Codes: A61B 5/1486 using enzyme electrodes, e.g. with immobilised oxidase
• CPC Class Codes: G01N 21/78 producing a change of colour
• CPC Class Codes: G01N 21/8483 Investigating reagent band test-element handling not specific to a test method G01N33/4875; analytical elements specific to chemical analysis of biological material G01N33/52; autometer with reagent band G01N35/04
• CPC Class Codes: G01N 27/3274 Corrective measures, e.g. error detection, compensation for temperature or hematocrit, calibration coding of calibration information G01N33/48771

Abstract

An assembly determines an analyte concentration in a sample of body fluid. The assembly includes a test sensor having a fluid-receiving area for receiving a sample of body fluid, where the fluid-receiving area contains a reagent that produces a measurable reaction with an analyte in the sample. The assembly also includes a meter having a port or opening configured to receive the test sensor; a measurement system configured to determine a measurement of the reaction between the reagent and the analyte; and a temperature-measuring system configured to determine a measurement of the test-sensor temperature when the test sensor is received into the opening. The meter determines a concentration of the analyte in the sample according to the measurement of the reaction and the measurement of the test-sensor temperature.

Claims

1. A system for determining an analyte concentration in a fluid sample, comprising:

a test sensor comprising a fluid-receiving area for receiving a fluid sample, the fluid-receiving area containing a reagent that produces a reaction with an analyte in the sample, the test sensor having a test-sensor temperature, the test sensor including a thermochromic material applied to a region of the test sensor;

a meter comprising;

an opening configured to receive the test sensor such that the region of the thermochromic material on the test sensor is disposed in the meter and the fluid-receiving area of the test sensor is disposed outside the meter;

a measurement system configured to determine a measurement of the reaction between the reagent and the analyte; and

a temperature-measuring system configured to estimate a measurement of the test-sensor temperature when the test sensor is received into the opening, the temperature-measuring system including an optical-sensing system configured to detect an interaction between light and the thermochromic material to estimate the measurement of the test-sensor temperature,

wherein the optical-sensing system detects the interaction between the light and the thermochromic material while the region of the thermochromic material on the test sensor is disposed in the meter and the fluid-receiving area of the test sensor is disposed outside the meter, and the meter determines a concentration of the analyte in the sample received on the fluid-receiving area of the test sensor using the measurement of the reaction and the measurement of the test-sensor temperature.

2. The system of claim 1, wherein the optical-sensing system includes a light source and a detector, the light source transmitting photons to the thermochromic material and the detector detecting an interaction between the photons and the thermochromic material.

3. The system of claim 2, wherein the light source includes one or more light emitting diodes (LED'"'"'s) and the detector includes one or more photodiodes.

4. The system of claim 2, wherein the light source includes three light emitting diodes (LED'"'"'s) emitting red, green, and blue wavelengths, respectively.

5. The system of claim 2, wherein the detector includes three photodiodes that detect levels of interactions between the thermochromic material and light having red, green, and blue wavelengths, respectively, the ratio between red, green, and blue levels of interaction changing with temperature.

6. The system of claim 2, wherein the detector includes an integrated red/green/blue (RGB) color sensor that detect levels of interactions between the thermochromic material and light having red, green, and blue wavelengths, respectively, the ratio between red, green, and blue levels of interaction changing with temperature.

7. The system of claim 2, wherein the light source is a light emitting diode (LED) emitting photons of a predetermined wavelength and the detector measures photons of the predetermined wavelength interacting with the thermochromic material.

8. The system of claim 1, wherein the region of the test sensor includes an array of segments of thermochromic material, the thermochromic material in each segment of the array being sensitive to a respective temperature range.

9. The system of claim 8, wherein the optical-sensing system includes a plurality of light emitting diodes (LEDs), each LED emitting photons to a respective segment in the array.

10. The system of claim 1, wherein the thermochromic material includes thermochromic liquid crystals (TCLCs).

11. The system of claim 1, wherein the interaction between light and the thermochromic material includes at least one of reflection, absorption, and scattering.

12. A method for determining an analyte concentration in a sample of body fluid, comprising the steps of:

placing a test sensor into an opening of a meter, the opening being configured to receive the test sensor, the test sensor comprising a fluid-receiving area for receiving a sample of body fluid, the fluid-receiving area containing a reagent that produces a reaction with an analyte in the sample, the test sensor having a test-sensor temperature, the test sensor including a thermochromic material applied to a region of the test sensor, wherein the region of the thermochromic material on the test sensor is disposed in the meter and the fluid-receiving area of the test sensor is disposed outside the meter;

estimating a measurement of the test-sensor temperature when the test sensor is received into the opening by detecting, with an optical-sensing system, an interaction between light and the thermochromic material while the region of the thermochromic material on the test sensor is disposed in the meter and the fluid-receiving area of the test sensor is disposed outside the meter;

measuring the reaction between the reagent and the analyte in the sample; and

determining a concentration of the analyte in the sample according to the measurement of the reaction and the measurement of the test-sensor temperature.

13. The method of claim 12, wherein detecting an interaction between light and the thermochromic material includes transmitting photons from a light source to the thermochromic material and detecting, with a detector, an interaction between the photons and the thermochromic material.

14. The method of claim 13, wherein the light source includes one or more light emitting diodes (LED'"'"'s) and the detector includes one or more photodiodes.

15. The method of claim 13, wherein the light source includes three light emitting diodes (LED'"'"'s) emitting red, green, and blue wavelengths, respectively.

16. The method of claim 13, wherein the detector includes three photodiodes that detect levels of interactions between the thermochromic material and light having red, green, and blue wavelengths, respectively.

17. The method of claim 13, wherein the detector includes an integrated red/green/blue (RGB) color sensor that detect levels of interactions between the thermochromic material and light having red, green, and blue wavelengths, respectively.

18. The method of claim 13, wherein the light source is a light emitting diode (LED) emitting photons of a predetermined wavelength and the detector measures photons of the predetermined wavelength interacting with the thermochromic material.

19. The method of claim 12, wherein the region of the test sensor includes an array of segments of thermochromic material, the thermochromic material in each segment of the array being sensitive to a respective temperature range, and the optical-sensing system includes a plurality of light emitting diodes (LEDs), each LED emitting photons to a respective segment in the array.

20. The method of claim 12, wherein the thermochromic material includes thermochromic liquid crystals (TCLCs).