Method for making calibration-adjusted sensors

• US 7,866,026 B1
• Filed: 08/01/2006
• Issued: 01/11/2011
• Est. Priority Date: 08/01/2006
• Status: Active Grant

• Current Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories)
• Original Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories)
• Inventors: Wang, Yi, Feldman, Benjamin J.
• Primary Examiner(s): Tugbang; A. Dexter
• Assistant Examiner(s): CAZAN, LIVIUS RADU
• Application Number:
  US11/461,725
• Publication Number:
  US 20100325868A1
• Time in Patent Office: 1,624 Days
• Field of Search: 295/94, 295/95, 298/30, 298/31, 298/46, 298/54, 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:

providing a plurality of pre-sensors, each pre-sensor comprising a working electrode, a counter electrode, and a sample chamber, wherein the sample chamber has at least part of the working electrode and the counter electrode arranged therein, wherein the plurality of pre-sensors includes at least a first pre-sensor and a second pre-sensor;

physically modifying the first pre-sensor to form a first sensor, the first sensor having first physical characteristics defining a first slope and y-intercept;

determining the first slope and the first 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 is within the predetermined level of slopes and y-intercepts, physically modifying the second pre-sensor to form a second sensor having a the first physical characteristics, wherein physically modifying the first pre-sensor and the second pre-sensor comprises modifying an electrode area in the sample chamber;

or

wherein when the first slope and y-intercept 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 second physical characteristics defining a second slope and y-intercept of the second sensor that is within the predetermined level of slopes and y-intercepts, wherein physically modifying the first pre-sensor and the second pre-sensor comprises modifying an electrode area in the sample chamber.

2. The method of claim 1, further comprising

when the first slope and y-intercept are within the predetermined level of slopes and y-intercepts, physically modifying at least 99 additional pre-sensors of the plurality of pre-sensors to provide at least 99 additional sensors having the first physical characteristics.

3. The method of claim 1, wherein providing the plurality of pre-sensors further comprises:

providing a first substrate having a plurality of working electrodes thereon, the plurality of working electrodes including the working electrode for each pre-sensor of the plurality of pre-sensors;

providing a spacer layer over the first substrate; and

overlaying the spacer layer with a second substrate.

4. The method of claim 1, wherein the calibration-adjusted sensors are tip-fill sensors, side-fill sensors, corner-fill sensors, or top-fill sensors.

5. The method of claim 1, wherein the first physical characteristics include a size of the sample chamber of the first sensor and wherein the second physical characteristics include a size of the sample chamber of the second sensor.

6. The method of claim 1, wherein physically modifying the first and second pre-sensors comprises modifying a size of the first and second pre-sensor sample chambers.

7. The method of claim 1, wherein the first and second physical characteristics relate to at least one of the working electrode and the counter electrode of the first and second sensors.

8. The method of claim 1, wherein physically modifying the first and second pre-sensors comprises modifying a size of the working electrode and counter electrode of the first and second pre-sensors.

9. The method of claim 1, wherein physically modifying the first and second pre-sensors comprises modifying at least one of the sample chamber, a measurement zone, and electrode configuration, an electrode dimension, an enzyme, a mediator, a polymer, a chemistry concentration, and any combination thereof.

10. The method of claim 1, further comprising:

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

11. The method of claim 1, further comprising:

when the first slope and y-intercept 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, wherein the plurality of pre-sensors are from the same lot and include the plurality of additional pre-sensors.

12. The method of claim 1, further comprising:

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

13. The method of claim 1, further comprising:

when the first slope and y-intercept 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, wherein the plurality of pre-sensors are from the same lot and include the plurality of additional pre-sensors.

14. The method of claim 13, wherein the plurality of additional pre-sensors are from the same sheet as the first pre-sensor and second pre-sensor.

15. The method of claim 13, wherein the physically modifying of the second pre-sensor and the plurality of additional pre-sensors comprises modifying an electrode area in a sample chamber.

16. The method of claim 1, wherein when the first slope and y-intercept deviate above the predetermined level of slopes and y-intercept, the physically modifying of the second pre-sensor comprises physically modifying a sample chamber such that an electrode area of the sample chamber is reduced.