System and apparatus for determining temperatures in a fluid analyte system

• US 9,097,650 B2
• Filed: 12/02/2013
• Issued: 08/04/2015
• Est. Priority Date: 06/23/2009
• Status: Active Grant

• Current Assignee: Ascensia Diabetes Care Holdings AG (PHC Holdings Corporation)
• Original Assignee: Bayer Healthcare LLC (Bayer AG)
• Inventors: Sun, Steve Hoi-Cheong, Chinnayelka, Swetha, Creaven, John P., Edelbrock, Andrew J., Holzer, Matthew B., Parasnis, Narasinha C., Reynolds, Jeffery S., Ripley, Paul M., Charlton, Steven C., Wang, Xin, Wu, Mu
• Primary Examiner(s): Noguerola, Alex
• Application Number:
  US14/094,434
• Publication Number:
  US 20140083848A1
• Time in Patent Office: 610 Days
• Field of Search: 204/400, 20440301-40315, 204/408, 422 8201- 8209, 422/87, 422400-407, 422/412
• US Class Current: 1/1
• CPC Class Codes: A61B 5/01 Measuring temperature of body parts ; Diagnostic temperature sensing, e.g. for malignant or inflamed tissue clinical contact thermometers G01K13/20
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/14546 for measuring analytes not otherwise provided for, e.g. ions, cytochromes
• CPC Class Codes: A61B 5/1486 using enzyme electrodes, e.g. with immobilised oxidase
• CPC Class Codes: G01K 13/00 Thermometers specially adapted for specific purposes
• CPC Class Codes: G01K 3/08 giving differences of values using thermoelectric elements G01K7/02; giving differentiated values
• CPC Class Codes: G01K 7/01 using semiconducting elements having PN junctions G01K7/02, G01K7/16, G01K7/30 take precedence
• CPC Class Codes: G01K 7/02 using thermoelectric elements, e.g. thermocouples
• CPC Class Codes: G01K 7/16 using resistive elements resistive elements per se H01C, H01L
• CPC Class Codes: G01N 27/26 by investigating electrochemical variables; by using electrolysis or electrophoresis
• CPC Class Codes: G01N 27/308 at least partially made of carbon
• CPC Class Codes: G01N 27/3272 Test elements therefor, i.e. disposable laminated substrates with electrodes, reagent and channels optical biosensors G01N33/52
• CPC Class Codes: G01N 27/3274 Corrective measures, e.g. error detection, compensation for temperature or hematocrit, calibration coding of calibration information G01N33/48771
• CPC Class Codes: G01N 27/4166 measuring a particular property of an electrolyte
• CPC Class Codes: G01N 33/48785 Electrical and electronic details of measuring devices for physical analysis of liquid biological material not specific to a particular test method, e.g. user interface or power supply
• CPC Class Codes: G01N 33/49 Blood chemical methods for determining blood cell populations G01N33/5094; chemical analysis of blood groups or blood types G01N33/80
• CPC Class Codes: Y10T 29/49155 Manufacturing circuit on or in base

Abstract

A test sensor includes a body, a first conductive trace, a second conductive trace, and a third conductive trace. The body includes a first region that has a fluid-receiving area, a second region separate from the first region, and a first temperature sensing interface disposed at or adjacent to the fluid-receiving area. The fluid-receiving area receives a sample. The first trace is disposed on the body, and at least a portion of the first trace is disposed in the first region. The second and third traces are disposed on the body. The third trace extends from the first to the second regions. The third trace is connected to the first trace at the first temperature sensing interface. The third trace includes a different material than the first trace. A first thermocouple is formed at the first temperature sensing interface. The thermocouple provides temperature data to determine an analyte concentration.

Claims

1. A test sensor for determining a fluid analyte concentration, comprising:

a test sensor body including a capillary channel for receiving a fluid sample;

a first temperature sensor located in the capillary channel; and

a second temperature sensor disposed on the test sensor body and located outside of the capillary channel, the first temperature sensor and the second temperature sensor being configured to provide temperature data to assist in determining the fluid analyte concentration or determining an error.

2. The test sensor of claim 1, wherein the second temperature sensor is configured to detect an ambient temperature.

3. The test sensor of claim 2, wherein the test sensor body includes a first portion and a second portion separated by a break junction, the second portion being configured to separate from the first portion along the break junction, the second temperature sensor being located on the second portion so as to be exposed to an environment outside the test sensor body when the second portion separates from the first portion.

4. The test sensor of claim 3, wherein the test sensor body includes a base and a lid, the second portion being a flap extending from the lid.

5. The test sensor of claim 1, wherein the second temperature sensor is located at or in close proximately to a connection end of the test sensor body for connecting to a meter.

6. The test sensor of claim 1, further comprising a reagent, the first temperature sensor being located at or in close proximity to a region in which a chemical reaction between the sample fluid and the reagent occurs.

7. The test sensor of claim 1, further comprising a working electrode and a counter electrode located in the capillary channel, the first temperature sensor being located at or in close proximity to at least one of the working electrode or the counter electrode.

8. The test sensor of claim 1, wherein the first temperature sensor and the second temperature sensor each include a thermocouple, a thermopile, a diode device, or a resistive temperature detector (RTD).

9. The test sensor of claim 1, wherein the first temperature sensor is a first thermocouple, the first thermocouple being formed at an interface between a first conductive trace and a second conductive trace, the first conductive trace being comprised of a different conductive material than the second conductive trace.

10. The test sensor of claim 9, wherein the second temperature sensor is a second thermocouple, the second thermocouple being formed by an interface between the second conductive trace and a third conductive trace, the second conductive trace being comprised of a different conductive material than the third conductive trace.

11. A system for determining temperature differentials in a test sensor, comprising:

a test sensor configured to be receivable by a meter including;

a test sensor body including a fluid-receiving end, a connection end, and a capillary channel extending from the fluid-receiving end toward the connection end,

a first temperature sensor located in the capillary channel, and

a second temperature sensor located outside of the capillary channel; and

the meter including a third temperature sensor, the meter being configured to receive the connection end of the test sensor body, the first temperature sensor and the second temperature sensor being communicatively coupled to the meter to provide temperature data indicative of a temperature differential, the meter being configured to utilize the temperature differential with additional temperature data provided by the third temperature sensor to assist in determining the fluid analyte concentration or determining an error.

12. The system of claim 11, wherein the second temperature sensor is located adjacent to the third temperature sensor when the connection end of the test sensor body is received in the meter.

13. The system of claim 11, wherein the third temperature sensor is located at or in close proximity to a location where an ambient temperature is known.

14. The system of claim 11, wherein at least one of the first temperature sensor or the second temperature sensor is a thermocouple.

15. The system of claim 14, wherein the meter is configured to utilize a signal communicated from at least one of the first temperature sensor or the second temperature sensor as a low voltage power source.

16. The system of claim 11, wherein the meter is configured to not start an assay of a fluid sample if an error is determined based on the temperature differential from the first temperature sensor and the second temperature sensor and the temperature data from the third temperature sensor.

17. A method for determining temperature differentials in a test sensor, comprising:

providing a test sensor including;

a test sensor body including a fluid-receiving end, a connection end, and a capillary channel extending from the fluid-receiving end toward the connection end,

a first temperature sensor located in the capillary channel, and

a second temperature sensor located outside of the capillary channel;

applying a fluid sample to the test sensor;

measuring, using the first temperature sensor, a first temperature at a location within the capillary channel;

measuring, using the second temperature sensor, a second temperature at a location outside of the capillary channel; and

determining a temperature differential based on the first temperature and the second temperature.

18. The method of claim 17, wherein the second temperature is an ambient temperature measured in an ambient environment outside of the test sensor body.

19. The method of claim 17, wherein the first temperature is measured at or in close proximity to where a chemical reaction occurs between the fluid sample and a reagent.

20. The method of claim 17, further comprising determining an analyte concentration of the fluid sample based on the determined temperature differential.