Method of making calibration-adjusted analyte sensors

• US 7,918,012 B2
• Filed: 10/30/2007
• Issued: 04/05/2011
• Est. Priority Date: 08/01/2006
• Status: Active Grant

• Current Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Inventors: Wang, Yi, Feldman, Benjamin J.
• Primary Examiner(s): Tugbang; A. Dexter
• Assistant Examiner(s): Cazan; Livius R
• Application Number:
  US11/981,377
• Publication Number:
  US 20080060196A1
• Time in Patent Office: 1,253 Days
• Field of Search: 295/95, 298/30, 298/46, 298/47, 298/50, 298/54, 298/74, 298/76, 295/93, 600/309, 600/583, 600/584, 204/403.01
• US Class Current: 29/593
• 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 plurality of calibration-adjusted sensors, comprising:

physically modifying a first pre-sensor to provide a first sensor having first physical characteristics, wherein the first physical characteristics define a first slope and y-intercept of the first sensor;

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

comparing the first slope and y-intercept of the first sensor to a predetermined level of slopes and y-intercepts; and

wherein when the first slope and y-intercept of the first sensor is within the predetermined level of slopes and y-intercepts, physically modifying a second pre-sensor to provide a second sensor having the first physical characteristics, the physically modifying of the second pre-sensor comprising modifying a sample chamber of the second pre-sensor;

or

wherein when the first slope and y-intercept of the first sensor deviates outside the predetermined level of slopes and y-intercepts, physically modifying the second pre-sensor based on the deviation to provide a second sensor having second physical characteristics, the physically modifying of the second pre-sensor comprising modifying a sample chamber of the second pre-sensor, wherein the second physical characteristics define a second slope and y-intercept of the second sensor that is within the predetermined level of slopes and y-intercepts.

2. The method of claim 1, wherein the physically modifying of the second pre-sensor comprises modifying an electrode area in the sample chamber.

3. The method of claim 1, wherein the physically modifying of the second pre-sensor comprises modifying a volume of the sample chamber.

4. The method of claim 1, further comprising:

when the first slope and y-intercept of the first sensor are within the predetermined level of slopes and y-intercepts, physically modifying a third pre-sensor to provide a third sensor having the first physical characteristics, the physically modifying of the third pre-sensor comprising modifying a sample chamber of the third pre-sensor.

5. The method of claim 1, further comprising:

when the first slope and y-intercept of the first sensor are within the predetermined level of slopes and y-intercepts, physically modifying a plurality of additional pre-sensors to provide a plurality of additional sensors having the first physical characteristics, the physically modifying of the plurality of additional pre-sensors comprising modifying sample chambers of the plurality of additional pre-sensors, wherein the plurality of additional pre-sensors are from the same lot as the first pre-sensor and the second pre-sensor.

6. The method of claim 1, further comprising:

when the first slope and y-intercept of the first sensor deviate outside the predetermined level of slopes and y-intercepts, physically modifying a third pre-sensor to provide a third sensor having the second physical characteristics, the physically modifying of the third pre-sensor comprising modifying a sample chamber of the third pre-sensor.

7. The method of claim 1, further comprising:

when the first slope and y-intercept of the first sensor deviate outside the predetermined level of slopes and y-intercepts, physically modifying a plurality of additional pre-sensors to provide a plurality of additional sensors having the second physical characteristics, the physically modifying of the plurality of additional pre-sensors comprising modifying sample chambers of the plurality of additional pre-sensors, wherein the plurality of additional pre-sensors are from the same lot as the first pre-sensor and second pre-sensor.

8. The method of claim 7, wherein the plurality of pre-sensors are from the same sheet as the first pre-sensor and second pre-sensor.

9. The method of claim 7, wherein the physically modifying of the second pre-sensor and the plurality of additional pre-sensors comprise modifying an electrode area in each sample chamber.

10. The method of claim 7, wherein the physically modifying of the second pre-sensor and the plurality of additional pre-sensors comprise modifying a volume of each sample chamber.

11. The method of claim 1, wherein when the first slope and y-intercept of the first sensor deviate above the predetermined level of slopes and y-intercept, the modifying of the sample chamber of the second pre-sensor comprises reducing a volume of the sample chamber.

12. The method of claim 1, wherein when the first slope and y-intercept deviate above the predetermined level of slopes and y-intercept, the modifying of the sample chamber of the second pre-sensor comprises reducing an electrode area of the sample chamber.