Auto-calibrating test sensor and method of making the same

• US 8,906,209 B2
• Filed: 12/08/2008
• Issued: 12/09/2014
• Est. Priority Date: 12/10/2007
• Status: Active Grant

• Current Assignee: Ascensia Diabetes Care Holdings AG (PHC Holdings Corporation)
• Original Assignee: Bayer Healthcare LLC (Bayer AG)
• Inventors: Lieber, Harris A., Perry, Joseph E.
• Primary Examiner(s): Van, Luan
• Assistant Examiner(s): Kessel, Maris R
• Application Number:
  US12/746,803
• Publication Number:
  US 20100255567A1
• Time in Patent Office: 2,192 Days
• Field of Search: 20440301-40315, 205/775, 205/777.5, 205/792
• US Class Current: 204/403.01
• 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 33/48771 Coding of information, e.g. calibration data, lot number
• CPC Class Codes: Y10T 29/49139 by inserting component lead or terminal into base aperture

Abstract

An electrochemical test sensor (10) for determining an analyte in a fluid sample, includes a base (12) and a second layer. The base (12) includes a plurality of electrodes (30,32), a working conductive lead (42) and a counter conductive lead (40) thereon. The electrodes include a working electrode (32) and a counter electrode (30). The second layer (20) assists in forming a channel (22) in which the channel includes a reagent therein. Auto-calibration information of the test sensor is performed by a plurality of auto-calibration segments (75) connected to one of the following: the working conductive lead (42), the counter conductive lead (40), or neither of the conductive leads, at least one of the plurality of auto-calibration segments (75a) being connected to the working conductive lead (42) and at least one of the plurality of auto-calibration segments (75b) being connected to the counter conductive lead (40).

Claims

1. A method of making an electrochemical test sensor adapted to assist in determining information relating to an analyte in a fluid sample, the method comprising the acts of:

providing a base;

providing a second layer to assist in forming a channel;

providing a plurality of electrodes on the base, the plurality of electrodes including a working electrode and a counter electrode;

providing a working conductive lead that is electrically connected to the working electrode;

providing a counter conductive lead that is electrically connected to the counter electrode;

providing a reagent formed in the channel; and

providing auto-calibration information of the test sensor by forming a plurality of auto-calibration segments to be connected to one of the following;

the working conductive lead, the counter conductive lead, or neither of the conductive leads, and wherein at least one of the plurality of auto-calibration segments is connected to the working conductive lead and at least one of the plurality of auto-calibration segments is connected to the counter conductive lead;

wherein each of a first plurality of auto-calibration areas is located between a first portion of the working conductive lead and a portion of the counter conductive lead and each of a second plurality of auto-calibration areas is located between a second portion of the working conductive lead and a portion of the counter conductive lead, the location of the first plurality of auto-calibration areas being different from the second plurality of auto-calibration areas;

wherein each of the first plurality of auto-calibration areas is located on an opposing side of the counter conductive lead as compared to each of the second plurality of auto-calibration areas;

wherein the working conductive lead extends along at least a portion of two peripheries of the electrochemical test sensor.

2. The method of claim 1 wherein the second layer is a lid, the lid assisting in forming a channel in which to receive the fluid, the channel including the reagent.

3. The method of claim 1 wherein the second layer is a spacer and wherein the test further includes a lid, the spacer and lid assisting in forming a channel in which to receive the fluid.

4. The method of claim 1 wherein the reagent includes glucose oxidase or glucose dehydrogenase.

5. The method of claim 1 wherein at least one of the plurality of auto-calibration leads is connected to neither the working conductive lead nor the counter conductive lead.

6. The method of claim 1 wherein providing the plurality of electrodes and the conductive leads on the base includes placing an electrochemically-active layer on the base and laser-ablating the electrochemically-active layer.

7. The method of claim 1 wherein the channel is a capillary channel.

8. The method of claim 1 wherein providing the plurality of electrodes and the conductive leads on the base includes printing the plurality of electrodes and the conductive leads on the base.

9. The method of claim 1 wherein providing auto-calibration information of the test sensor by forming the plurality of auto-calibration segments includes providing a plurality of auto-calibration areas connected to the working and counter conductive areas and shorting the same.

10. The method of claim 1 wherein the plurality of auto-calibration segments includes at least six auto-calibration segments.

11. The method of claim 10 wherein the plurality of auto-calibration segments includes at least eight auto-calibration segments.

12. The method of claim 1 wherein the working conductive lead is generally in a U-shape configuration.

13. An electrochemical test sensor being adapted to assist in determining information relating to an analyte in a fluid sample, the test sensor comprising:

a base including a plurality of electrodes, a working conductive lead and a counter conductive lead thereon, the plurality of electrodes including a working electrode and a counter electrode; and

a second layer to assist in forming a channel, the channel including a reagent therein;

wherein auto-calibration information of the test sensor is determined by using a plurality of auto-calibration segments connected to one of the following;

the working conductive lead, the counter conductive lead, or neither of the conductive leads;

wherein at least one of the plurality of auto-calibration segments being connected to the working conductive lead and at least one of the plurality of auto-calibration segments being connected to the counter conductive lead;

wherein each of a first plurality of auto-calibration areas is located between a first portion of the working conductive lead and a portion of the counter conductive lead and each of a second plurality of auto-calibration areas is located between a second portion of the working conductive lead and a portion of the counter conductive lead, the location of the first plurality of auto-calibration areas being different from the second plurality of auto-calibration areas;

wherein each of the first plurality of auto-calibration areas is located on an opposing side of the counter conductive lead as compared to each of the second plurality of auto-calibration areas;

wherein the working conductive lead extends along at least a portion of two peripheries of the electrochemical test sensor.

14. The test sensor of claim 13 wherein the second layer is a lid, the lid assisting in forming a channel in which to receive the fluid, the channel including the reagent.

15. The test sensor of claim 13 wherein the second layer is a spacer and wherein the test further includes a lid, the spacer and lid assisting in forming a channel in which to receive the fluid.

16. The test sensor of claim 13 wherein the reagent includes glucose oxidase or glucose dehydrogenase.

17. The test sensor of claim 13 wherein at least one of the plurality of auto-calibration segments is connected to neither the working conductive lead nor the counter conductive lead.

18. The test sensor of claim 13 wherein the channel is a capillary channel.

19. The test sensor of claim 13 wherein the plurality of auto-calibration segments includes at least six auto-calibration segments.

20. The test sensor of claim 13 wherein the plurality of auto-calibration segments includes at least eight auto-calibration segments.

21. The test sensor of claim 13 wherein the working conductive lead is generally in a U-shape configuration.

22. A method of making an electrochemical test sensor adapted to assist in determining information relating to an analyte in a fluid sample, the method comprising the acts of:

providing a base;

providing a second layer to assist in forming a channel;

providing a plurality of electrodes on the base, the plurality of electrodes including a working electrode and a counter electrode;

providing a working conductive lead that is electrically connected to the working electrode;

providing a counter conductive lead that is electrically connected to the counter electrode;

providing a reagent formed in the channel; and

providing auto-calibration information of the test sensor by forming a plurality of auto-calibration segments to be connected to one of the following;

the working conductive lead, the counter conductive lead, or neither of the conductive leads, and wherein at least one of the plurality of auto-calibration segments is connected to the working conductive lead and at least one of the plurality of auto-calibration segments is connected to the counter conductive lead;

wherein each of a first plurality of auto-calibration areas is located between a first portion of the working conductive lead and a portion of the counter conductive lead and each of a second plurality of auto-calibration areas is located between a second portion of the working conductive lead and the portion of the counter conductive lead, the location of the first plurality of auto-calibration areas being different from the second plurality of auto-calibration areas;

wherein each of the first plurality of auto-calibration areas is located on an opposing side of the portion of the counter conductive lead as compared to each of the second plurality of auto-calibration areas;

wherein the working conductive lead is generally in a U-shape configuration.

23. An electrochemical test sensor being adapted to assist in determining information relating to an analyte in a fluid sample, the test sensor comprising:

a base including a plurality of electrodes, a working conductive lead and a conductive lead thereon, the plurality of electrodes including a working electrode and a counter electrode; and

a second layer to assist in forming a channel, the channel including a reagent therein;

wherein auto-calibration information of the test sensor is determined by using a plurality of auto-calibration segments connected to one of the following;

the working conductive lead, the counter conductive lead, or neither of the conductive leads;

wherein at least one of the plurality of auto-calibration segments being connected to the working conductive lead and at least one of the plurality of auto-calibration segments being connected to the counter conductive lead;

wherein each of a first plurality of auto-calibration areas is located between a first portion of the working conductive lead and a portion of the counter conductive lead and each of a second plurality of auto-calibration areas is located between a second portion of the working conductive lead and the portion of the counter conductive lead, the location of the first plurality of auto-calibration areas being different from the second plurality of auto-calibration areas;

wherein each of the first plurality of auto-calibration areas is located on an opposing side of the portion of the counter conductive lead as compared to each of the second plurality of auto-calibration areas;

wherein the working conductive lead is generally in a U-shape configuration.