System and apparatus for determining temperatures in a fluid analyte system

• US 9,664,644 B2
• Filed: 06/24/2015
• Issued: 05/30/2017
• Est. Priority Date: 06/23/2009
• Status: Active Grant

• Current Assignee: Ascensia Diabetes Care Holdings AG (PHC Holdings Corporation)
• Original Assignee: Ascensia Diabetes Care Holdings AG (PHC Holdings Corporation)
• Inventors: Creaven, John P., Edelbrock, Andrew J., Charlton, Steven C., Wu, Mu, Parasnis, Narasinha C., Reynolds, Jeffery S., Ripley, Paul M., Sun, Steve Hoi-Cheong, Chinnayelka, Swetha, Holzer, Matthew B., Wang, Xin
• Primary Examiner(s): Noguerola, Alexander
• Application Number:
  US14/749,318
• Publication Number:
  US 20150293055A1
• Time in Patent Office: 706 Days
• 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 configured to determine a fluid analyte concentration of a fluid sample, the sensor comprising:

a test sensor body including a first region that has a fluid-receiving area, a second region that is separate from the first region, and a first temperature sensing interface that is disposed at or adjacent to the fluid-receiving area, the fluid-receiving area being configured to receive a fluid sample and allowing the fluid sample to be analyzed to determine a fluid analyte concentration;

a first conductive trace disposed on the test sensor body, at least a portion of the first conductive trace being disposed in the first region;

a second conductive trace disposed on the test sensor body; and

a third conductive trace disposed on the test sensor body, the third conductive trace extending from the first region to the second region, the third conductive trace connected to the first conductive trace at the first temperature sensing interface, the third conductive trace comprised of a different material than the first conductive trace such that a first thermocouple is formed at the first temperature sensing interface, the first thermocouple providing temperature data to assist in determining the fluid analyte concentration,

wherein the first conductive trace and the second conductive trace are used to determine the fluid analyte concentration of the fluid sample.

2. The test sensor of claim 1, wherein the first conductive trace is a working electrode.

3. The test sensor of claim 1, wherein the third conductive trace is further connected to the second conductive trace at a second temperature sensing interface, the second temperature sensing interface being located in the second region.

4. The test sensor of claim 1, wherein the test sensor body comprises a base and a lid disposed above the base, and the first conductive trace and the third conductive trace are disposed on the base.

5. The test sensor of claim 4, further comprising a counter electrode and working electrode disposed on the lid.

6. The test sensor of claim 1, wherein the test sensor body comprises a base and a lid disposed above the base, and the first conductive trace and the third conductive trace are disposed on the lid.

7. The test sensor of claim 6, further comprising a counter electrode and working electrode disposed on the base.

8. The test sensor of claim 1, wherein the test sensor body comprises a base and a lid, one of the base or the lid including a moveable flap.

9. The test sensor of claim 8, wherein the first temperature sensing interface is located at or adjacent to the moveable flap.

10. The test sensor of claim 1, wherein the first conductive trace and the third conductive trace are electrochemically compatible.

11. The test sensor of claim 10, wherein the first conductive trace comprises a noble metal and the third conductive trace comprises a carbon-based material.

12. A method for making a test sensor configured to determine a fluid analyte concentration of a fluid sample, the method comprising:

forming a first conductive trace on a test sensor body, the test sensor body including a first region that has a fluid-receiving area, a second region that is separate from the first region, and a first temperature sensing interface that is disposed at or adjacent to the fluid-receiving area, the fluid-receiving area being configured to receive a fluid sample and allowing the fluid sample to be analyzed to determine a fluid analyte concentration, at least a portion of the first conductive trace being disposed in the first region;

forming a second conductive trace on the test sensor body; and

forming a third conductive trace on the test sensor body, the third conductive trace extending from the first region to the second region, the third conductive trace connected to the first conductive trace at the first temperature sensing interface, the third conductive trace comprised of a different material than the first conductive trace such that a first thermocouple is formed at the first temperature sensing interface, the thermocouple providing temperature data to assist in determining the fluid analyte concentration,

wherein the first conductive trace and the second conductive trace are used to determine the fluid analyte concentration of the fluid sample.

13. A method for making a test sensor configured to determine a fluid analyte concentration of a fluid sample, the method comprising:

forming a metal layer on a substrate;

attaching the substrate with the metal layer to a test sensor body, the test sensor body including a first region that has a fluid-receiving area, a second region that is separate from the first region, and a first temperature sensing interface that is disposed at or adjacent to the fluid-receiving area, the fluid-receiving area being configured to receive a fluid sample and allowing the fluid sample to be analyzed to determine a fluid analyte concentration;

forming a first conductive trace on the metal layer, at least a portion of the first conductive trace being disposed in the first region;

forming a second conductive trace on the metal layer; and

forming a third conductive trace on the metal layer, the third conductive trace extending from the first region to the second region, the third conductive trace connected to the first conductive trace at the first temperature sensing interface, the third conductive trace comprised of a different material than the first conductive trace such that a first thermocouple is formed at the first temperature sensing interface, the thermocouple providing temperature data to assist in determining the fluid analyte concentration.

14. The method of claim 13, wherein the substrate is a plastic material.

15. The method of claim 13, wherein forming a metal layer on the substrate comprises screen printing a metal material on the substrate.

16. The method of claim 13, wherein attaching the substrate to the test sensor body comprises applying the substrate to the test sensor body with the metal layer facing the test sensor body.

17. The method of claim 13, wherein the substrate is with the metal layer is a thin strip.

18. The method of claim 13, wherein forming the first conductive trace, the second conductive trace, and the third conductive trace occurs before the substrate is attached to the test sensor body.

19. The method of claim 18, wherein forming a metal layer on a substrate and forming the first conductive trace, the second conductive trace, and the third conductive trace occurs repeatedly at a standalone production station to form a plurality of strips and each strip is applied to a plurality of test sensor bodies on a separate production line.