ANALYTE SENSORS AND METHODS

• US 20090229122A1
• Filed: 05/08/2009
• Published: 09/17/2009
• 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.
• Granted Patent: US 7,996,988 B2
• Time in Patent Office: Days
• US Class Current: 29/832
• 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. -22. (canceled)

23. A method of making a plurality of calibration-adjusted sensors for use in determining a concentration of a ketone body in a sample, the method comprising:

(a) 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 include at least a first pre-sensor and a second pre-sensor;

(b) physically modifying the first pre-sensor to form a first sensor, the first sensor having a first physical characteristic defining a first slope and a first y-intercept;

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

(d) comparing the first slope of the first sensor to a first desired slope and comparing the first and y-intercept of the first sensor to a first desired y-intercept; and

(e) physically modifying the second pre-sensor to form a second sensor having a second physical characteristic defining a second slope and a second y-intercept of the second sensor such that the second slope of the second sensor is substantially equal to the first desired slope and such that the second y-intercept of the second sensor is substantially equal to the first desired y-intercept.

24. The method of claim 23, further comprising:

forming a third sensor by physically modifying a third pre-sensor of the plurality of pre-sensors subsequent to such that the third sensor has a third physical characteristic defining a third slope and a third y-intercept that is substantially equal to the first desired slope and the first desired y-intercept/ being substantially equal to the desired slope and y-intercept.

25. The method of claim 23, wherein the second sensor is physically different than the first sensor.

26. The method of claim 23, further comprising physically modifying at least 99 additional pre-sensors of the plurality of pre-sensors to form at least 99 additional sensors having physical characteristics defining slopes and y-intercepts that are substantially equal to the first desired slope and the first desired y-intercept.

27. The method of claim 23, wherein providing a plurality of pre-sensors further comprises:

providing a first substrate having the plurality of working electrodes thereon;

providing a spacer layer over the first substrate; and

overlaying the spacer layer with a second substrate.

28. The method of claim 23, wherein the sensor is a tip-fill sensor, a side-fill sensor, corner-fill sensor, or a top-fill sensor.

29. The method of claim 23, wherein physically modifying the first pre-sensor and the second pre-sensor comprises modifying a volume of the sample chamber.

30. The method of claim 23, wherein physically modifying the first pre-sensor and the second pre-sensor comprises modifying an electrode area in the sample chamber.

31. The method of claim 23, wherein at least the first slope and the first y-intercept of are different than the second slope and the second y-intercept.

32. The method of claim 23, wherein the first physical characteristic is a first size of the sample chambers of the first sensor and wherein the second physical characteristics is a second size of the sample chamber of the second sensor.

33. The method of claim 23, wherein the physically modifying the first and second pre-sensors comprises modifying a size of the first and second pre-sensor sample chambers.

34. The method of claim 23, 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.

35. The method of claim 23, 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.

36. The method of claim 23, 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 mediators, a polymer, a chemistry concentration, and any combination thereof.