Methods of making a test sensor

• US 9,625,411 B2
• Filed: 03/24/2014
• Issued: 04/18/2017
• Est. Priority Date: 08/01/2006
• Status: Active Grant

• Current Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated), SAP AG (SAP SE)
• Original Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Inventors: Wang, Yi, Feldman, Benjamin J.
• Primary Examiner(s): Phan, Thiem
• Application Number:
  US14/223,654
• Publication Number:
  US 20140201988A1
• Time in Patent Office: 1,121 Days
• Field of Search: 29825, 29831, 29835, 29846, 29847, 29849, 29874, 20440301, 20440304, 20440311, 204412, 600345, 600347, 600365
• CPC Class Codes: G01N 27/3271 Amperometric enzyme electrodes for analytes in body fluids, e.g. glucose in blood amperometry per se G01N27/49; aspects concerning the enzyme reagent C12Q1/001
• 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: Y10T 29/49002 Electrical device making
• CPC Class Codes: Y10T 29/49004 including measuring or testing of device or component part
• CPC Class Codes: Y10T 29/49117 Conductor or circuit manufacturing
• CPC Class Codes: Y10T 29/49126 Assembling bases
• CPC Class Codes: Y10T 29/49128 Assembling formed circuit to base
• CPC Class Codes: Y10T 29/4913 Assembling to base an electrical component, e.g., capacitor, etc.
• CPC Class Codes: Y10T 29/49135 and shaping, e.g., cutting or bending, etc.
• CPC Class Codes: Y10T 29/49155 Manufacturing circuit on or in base
• CPC Class Codes: Y10T 29/49156 with selective destruction of conductive paths
• CPC Class Codes: Y10T 29/49169 Assembling electrical component directly to terminal or elongated conductor
• CPC Class Codes: Y10T 29/49204 Contact or terminal manufacturing

Abstract

A sensor, and methods of making, for determining the concentration of an analyte, such as glucose, in a biological fluid such as blood or serum, using techniques such as coulometry, amperometry, and potentiometry. The sensor includes a working electrode and a counter electrode, and may include an insertion monitoring trace to determine correct positioning of the sensor in a connector. The sensor is calibration-adjusted, eliminating the need for a user to enter a calibration code or for the meter to read a calibration code.

Claims

1. A method of making a calibration-adjusted sensor adapted to assist in determining the concentration of an analyte in a fluid sample, the method comprising the acts of:

attaching a first substrate to a second substrate to form a sensor, the sensor having a first end comprising a sample chamber, located between the first and second substrates, adapted to receive the fluid sample and a second opposing end adapted to be placed into a meter; and

physically altering the sample chamber of the sensor such that the volume of the sample chamber corresponds to auto-calibration information, wherein physically altering the sample chamber comprises decreasing a volume of the sample chamber and produces a calibration-adjusted sensor,

wherein the auto-calibration information is obtained from a test sensor.

2. The method of claim 1, wherein the sensor further includes a spacer, the spacer being located between the first and second substrates.

3. The method of claim 1, wherein the auto-calibration information is a program auto-calibration number.

4. The method of claim 1, wherein the sensor is an electrochemical sensor.

5. The method of claim 1, wherein the method comprises positioning electrodes on the first substrate.

6. The method of claim 5, wherein the method comprises positioning sensing material on at least one of the electrodes.

7. The method of claim 1, wherein the method comprises positioning an electrode on the first substrate and another electrode on the second substrate.

8. The method of claim 7, wherein the method comprises positioning sensing material on at least one electrode.

9. The method of claim 1, wherein the method comprises:

determining a first slope and y-intercept of the test sensor;

comparing the first slope and y-intercept of the test sensor to a predetermined level of slopes and y-intercepts corresponding to the auto-calibration information,

wherein the first slope and y-intercept is within the predetermined level of slopes and y-intercepts, and

wherein physically altering the sample chamber of the sensor comprises decreasing a volume of the sample chamber to match the volume of the test sensor.

10. The method of claim 1, wherein the method comprises:

determining a first slope and y-intercept of the test sensor;

comparing the first slope and y-intercept of the test sensor to a predetermined level of slopes and y-intercepts corresponding to the auto-calibration information,

wherein the first slope and y-intercept deviates outside the predetermined level of slopes and y-intercepts,

wherein physically altering the sample chamber of the sensor comprises decreasing a volume of the sample chamber based on the deviation.