Auto-calibrating test sensors

• US 8,241,488 B2
• Filed: 10/10/2008
• Issued: 08/14/2012
• Est. Priority Date: 11/06/2007
• Status: Active Grant

• Current Assignee: Ascensia Diabetes Care Holdings AG (PHC Holdings Corporation)
• Original Assignee: Bayer Healthcare LLC (Bayer AG)
• Inventors: Beer, Greg P.
• Primary Examiner(s): Olsen, Kaj K
• Application Number:
  US12/249,283
• Publication Number:
  US 20090113981A1
• Time in Patent Office: 1,404 Days
• Field of Search: 204/403.01, 204/403.02, 205/792, 205/777.5, 156/238, 156/269
• US Class Current: 205/792
• 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 33/48771 Coding of information, e.g. calibration data, lot number
• CPC Class Codes: Y10T 156/1084 of continuous or running length bonded web
• CPC Class Codes: Y10T 29/49002 Electrical device making

Abstract

An electrochemical test sensor configured to determine an analyte concentration of a fluid sample comprises a base including a first end, a second opposing end, a first side and a second side bridging the first and second opposing ends. The test sensor further comprises a plurality of electrodes formed on the base at or near the first end. The plurality of electrodes includes a working electrode and a counter electrode. The sensor further comprises a first test-sensor contact formed on the base at or near the second opposing end and coupled to the working electrode by a first conductive lead. The sensor further comprises a second test-sensor contact formed on the base at or near the second opposing end and coupled to the counter electrode by a second conductive lead. The positions of the first and second test-sensor contacts correspond with calibration information assigned to the test sensor.

Claims

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

forming a plurality of electrodes on a test-sensor base, the plurality of electrodes including a working electrode and a counter electrode;

forming a first test-sensor contact on the test-sensor base, the first test-sensor contact being coupled to the working electrode by a first conductive lead; and

forming a second test-sensor contact on the test-sensor base, the second test-sensor contact being coupled to the counter electrode by a second conductive lead;

after forming the first and second test-sensor contacts, determining calibration information to be used with the electrochemical test sensor; and

after determining the calibration information, cutting at least one side or end of the test-sensor base based on the calibration information such that the positions of the first and second test-sensor contacts on of the test-sensor base correspond to the calibration information associated with the electrochemical test sensor.

2. The method of claim 1, wherein the acts of forming a plurality of electrodes and forming the first and second test-sensor contacts are performed on a continuous web of material.

3. The method of claim 2, wherein the act of cutting at least one side or end of the test-sensor base includes separating the test-sensor base from the continuous web.

4. The method of claim 2, wherein the continuous web of material includes a plurality of test-sensor bases, the first and second test-sensor contacts being uniform among the plurality of test-sensor bases, wherein the act of cutting includes separating each of the plurality of test-sensor bases from one another such that at least two different types of electrochemical test sensors are formed, each of the different types of test sensors having different calibration information associated therewith.

5. The method of claim 1, wherein the act of cutting at least one side or end of the test-sensor base includes adjusting the length of the test-sensor base, the length being the distance from a testing end and a second opposing end of the test-sensor base.

6. The method of claim 5, wherein the position of the test-sensor contacts relative to the second opposing end corresponds to the calibration information.

7. The method of claim 1, wherein the test-sensor base includes a first and second side bridging a testing end and a second opposing end, the position of the test-sensor contacts relative to the first and second sides corresponding to the calibration information.

8. A method of associating calibration information with a test sensor configured to determine the concentration of an analyte in a fluid sample, the method comprising the acts of:

forming at least one test-sensor base having a first test-sensor contact and a second test-sensor contact, the first test-sensor contact being coupled to a working electrode by a first conductive lead, the second test-sensor contact coupled to a counter electrode by a second conductive lead;

after forming the first and second test-sensor contacts, determining calibration information to be used with the test sensor;

after determining the calibration information, forming at least one test sensor by cutting at least one of a testing end, a second opposing end, and a first and second side bridging the testing and second end of the test-sensor base based on the calibration information such that the positions of the first and second test-sensor contacts on the test sensor correspond to the calibration information associated with the test sensor, the working and counter electrodes being positioned at or near the testing end and the first and second test-sensor contacts being positioned at or near the second end;

providing a meter with a test-sensor opening, the meter including an array of contact pins for contacting the first and second test-sensor contacts, the array of contact pins being positioned within test-sensor opening;

placing the second end of the test sensor into the test-sensor opening of the meter;

contacting the test-sensor contacts with a first and second pin in the array of contact pins to detect the placement of the test-sensor contacts; and

determining the calibration information associated with the test sensor by which first and second pins contact the first and second test-sensor contacts.

9. The method of claim 8, wherein the act of forming the test sensor includes cutting the length of the test-sensor base, the length being the distance from the testing end and the second opposing end, the length corresponding to the calibration information.

10. The method of claim 8, wherein the position of the test-sensor contacts relative to the second opposing end corresponds to the calibration information.

11. The method of claim 8, wherein the position of the test-sensor contacts relative to the first and second sides corresponds to the calibration information.

12. The method of claim 8, wherein the act of forming the at least one test-sensor base includes forming a plurality of test-sensor bases, the first and second test-sensor contacts being uniform among the plurality of test-sensor bases.

13. The method of claim 12, wherein the plurality of test sensors are formed on a continuous web of material.

14. The method of claim 13, wherein the act of cutting forms at least two different types of test sensors having different calibration information associated therewith.