Methods of making analyte sensors

• US 7,895,740 B2
• Filed: 10/30/2007
• Issued: 03/01/2011
• 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): PHAN, THIEM D
• Application Number:
  US11/981,124
• Publication Number:
  US 20080066305A1
• Time in Patent Office: 1,218 Days
• Field of Search: 298/46, 298/31, 298/35, 298/47, 298/49, 298/74, 204/345, 204/347, 204/365, 600/403.01, 600/403.04, 600/403.11
• US Class Current: 29/846
• 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

Methods of making analyte sensors 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 are provided. 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 methods provide a sensor that 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 sensor comprising:

a) physically altering 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;

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

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

d) when the first slope and y-intercept are within the predetermined level of slopes and y-intercepts, physically altering a second pre-sensor to provide a second sensor having the first physical characteristics.

2. The method of claim 1, wherein physically altering the second pre-sensor comprises:

altering a volume of a sample chamber.

3. The method of claim 1, wherein physically altering the second pre-sensor comprises:

altering an electrode area.

4. The method of claim 1, further comprising:

e) physically altering a third pre-sensor to provide a third sensor having the first physical characteristics.

5. The method of claim 1, further comprising:

e) forming a third sensor having the first physical characteristics.

6. The method of claim 1, further comprising:

e) when the first slope and y-intercept are outside the predetermined level of slopes and y-intercepts, repeating steps a) and b) for a third pre-sensor;

wherein the third pre-sensor is physically altered to provide a third sensor having third physical characteristics, the third physical characteristics defining a third slope and y-intercept of the third sensor.

7. The method of claim 6, further comprising:

f) comparing the third slope and y-intercept to a predetermined level of slopes and y-intercepts; and

g) when the third slope and y-intercept are within the predetermined level of slopes and y-intercepts, physically altering a fourth pre-sensor to provide a fourth sensor having the third physical characteristics.

8. The method of claim 7, wherein physically altering the fourth pre-sensor comprises:

altering a volume of a sample chamber.

9. The method of claim 7, wherein physically altering the fourth pre-sensor comprises:

altering an electrode area.

10. The method of claim 6, wherein physically altering the third pre-sensor comprises:

altering a volume of a sample chamber.

11. The method of claim 6, wherein physically altering the third pre-sensor comprises:

altering an electrode area.

12. The method of claim 6, further comprising:

e) physically altering a fourth pre-sensor to provide a fourth sensor having the first physical characteristics.

13. The method of claim 1, further comprising:

e) forming a fourth sensor having the first physical characteristics.