METHOD AND ASSEMBLY FOR DETERMINING THE TEMPERATURE OF A TEST SENSOR

• US 20090098657A1
• Filed: 10/15/2008
• Published: 04/16/2009
• 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: Wang, Xin, Sun, Steve, Nguyen, Tony, Blais, Jeffrey D., Gofman, Igor, Harrison, Bern, Parasnis, Narasinha C., Ripley, Paul, Peteu, Serban F.
• Granted Patent: US 8,105,841 B2
• Time in Patent Office: Days
• 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. An assembly 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 measurable reaction with an analyte in the sample, the test sensor having a test-sensor temperature and the reagent having a reagent temperature;

a meter comprising;

an 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,

wherein the meter determines a concentration of the analyte in the sample using the measurement of the reaction and the measurement of the test-sensor temperature.

2. The assembly of claim 1, wherein the temperature-measuring system comprises a thermopile sensor configured to determine a measurement of the test-sensor temperature by measuring infrared radiation from the test sensor.

3. The assembly of claim 2, wherein the temperature-measuring system further comprises at least one of a thermistor, thermocouple, and a semiconductor temperature sensor configured to determine a measurement of a reference temperature corresponding to a body of the meter.

4. The assembly of claim 1, wherein the test sensor includes a thermochromic material applied thereto.

5. The assembly of claim 4, wherein the temperature-measuring assembly comprises an optical-sensing system configured to detect a temperature dependent color of the thermochromic material.

6. The system of claim 1, wherein the test-sensor temperature and the reagent temperature are at about ambient temperature.

7. The system of claim 1, wherein the opening extends from a first end proximate to an exterior surface of the meter to a second end in an interior of the meter, and the temperature-measuring assembly includes a temperature sensor that is positioned near the second end to minimize heat transfer to a region of the test sensor being measured by the temperature sensor.

8. The system of claim 1, wherein the temperature-measuring assembly includes a temperature sensor that receives a temperature-related signal from a region of the test sensor, and the temperature sensor and the region of the test sensor are separated by a space, the space forming an insulating air pocket around the region to minimize heat transfer to the region.

9. The system of claim 1, wherein any contact between the meter and the test sensor is a point contact to minimize heat transfer from the meter to the test sensor.

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

placing a test sensor into an opening, 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 measurable reaction with an analyte in the sample, the test sensor having a test-sensor temperature and the reagent having a reagent temperature;

determining a measurement of the test-sensor temperature when the test sensor is received into the opening; 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.

11. The method of claim 10, wherein the step of determining a measurement of the test-sensor temperature comprises measuring the test-sensor temperature with a thermopile sensor, the thermopile sensor measuring infrared radiation from the test sensor.

12. The method of claim 11, further comprising the step of determining a measurement of a reference temperature using a thermistor.

13. The method of claim 10, wherein the test sensor includes a thermochromic material applied thereto.

14. The method of claim 13, wherein the step of determining a measurement of the test-sensor temperature comprises measuring the test-sensor temperature with an optical-sensing system, the optical-sensing system configured to detect a temperature dependent color of the thermochromic material.

15. The method of claim 10, wherein the test-sensor temperature and the reagent temperature are at about an ambient temperature.

16. The method of claim 10, wherein the opening extends from a first end proximate to an exterior surface of the meter to a second end in an interior of the meter, and the act of placing a test sensor into an opening comprises positioning a temperature sensor near the second end to minimize heat transfer to a region of the test sensor being measured by the temperature sensor.

17. The method of claim 10, wherein the act of determining a measurement of the test-sensor temperature comprises receiving, via a temperature sensor, a temperature-related signal from a region of the test sensor, and the act of placing a test sensor into an opening comprises providing a space between the temperature sensor and the region of the test sensor, the space forming an insulating air pocket around the region to minimize heat transfer to the region.

18. The method of claim 10, wherein any contact between the meter and the test sensor is a point contact to minimize heat transfer from the meter to the test sensor.

19. An assembly for determining an analyte concentration in a fluid sample, comprising:

a test sensor that receives the fluid sample;

an optical-sensing system that determines a temperature of the test sensor; and

a device that receives the test sensor and measures an analyte concentration in a fluid sample according to the temperature determined by the optical-sensing system.