Analyte Sensors and Methods

• US 20120102722A1
• Filed: 01/12/2012
• Published: 05/03/2012
• 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 8,677,611 B2
• Time in Patent Office: Days
• US Class Current: 29/592.1
• 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. -22. (canceled)

23. A method of making a plurality of calibration-adjusted sensors comprising:

separating a first pre-sensor from a sheet construction to form a first sensor, the first sensor having physical characteristics defining a first slope and y-intercept, wherein the sheet construction comprises a plurality of pre-sensors including the first pre-sensor, 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;

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

when the first slope and y-intercept is within the predetermined level of slopes and y-intercepts, physically modifying a second pre-sensor of the plurality of pre-sensors to form a second sensor that is separated from the sheet construction, the second sensor having the first physical characteristics;

or

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 form a second sensor that is separated from the sheet construction, the 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 the second physical characteristics are different than the first characteristics;

wherein physically modifying the second pre-sensor comprises modifying the sample chamber of the second pre-sensor.

24. The method of claim 23, wherein the first pre-sensor and the second pre-sensor are from a same sheet of a same lot of the sheet construction.

25. The method of claim 23, wherein the first pre-sensor and the second pre-sensor are from a different sheet of a same lot of the sheet construction.

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

27. The method of claim 23, comprising:

when the first slope and y-intercept is within the predetermined level of slopes and y-intercepts, physically modifying a third pre-sensor of the plurality of pre-sensors to form a third sensor that is separated from the sheet construction, the third sensor having the first physical characteristics.

28. The method of claim 23, 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 form a plurality of additional sensors that are separated from the sheet construction, the plurality of additional sensors having the first physical characteristics, wherein the plurality of pre-sensors are from a same lot of the sheet construction and include the plurality of additional pre-sensors.

29. The method of claim 28, wherein the plurality of additional pre-sensors are from a same sheet of the same lot as the first pre-sensor.

30. The method of claim 28, wherein the plurality of additional pre-sensors are from a different sheet of the same lot as the first pre-sensor.

31. The method of claim 23, comprising:

when the first slope and y-intercept deviates outside the predetermined level of slopes and y-intercepts, physically modifying a third pre-sensor of the plurality of pre-sensors to form a third sensor that is separated from the sheet construction, the third sensor having the second physical characteristics.

32. The method of claim 23, comprising:

when the first slope and y-intercept deviates outside the predetermined level of slopes and y-intercepts, physically modifying a plurality of additional pre-sensors to form a plurality of additional sensors that are separated from the sheet construction, the plurality of additional sensors having the second physical characteristics, wherein the plurality of pre-sensors are from a same lot of the sheet construction and include the plurality of additional pre-sensors.

33. The method of claim 32, wherein the plurality of additional pre-sensors are from a same sheet of the same lot as the first pre-sensor.

34. The method of claim 32, wherein the plurality of additional pre-sensors are from a different sheet of the same lot as the first pre-sensor.

35. The method of claim 32, wherein the physically modifying of the second pre-sensor and the plurality of additional pre-sensors comprises modifying an electrode area in the sample chamber.

36. The method of claim 32, wherein the physically modifying of the second pre-sensor and the plurality of additional pre-sensors comprise modifying a volume of the sample chamber.

37. The method of claim 23, wherein when the first slope and y-intercept deviates above the predetermined level of slopes and y-intercept, the physically modifying of the sample chamber of the second pre-sensor comprises reducing an electrode area of the sample chamber.

38. The method of claim 23, wherein when the first slope and y-intercept of the first sensor deviates above the predetermined level of slopes and y-intercept, the physically modifying of the sample chamber of the second pre-sensor comprises reducing a volume of the sample chamber.

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

40. A method of making a plurality of calibration-adjusted sensors comprising:

separating a first pre-sensor from a sheet construction to form a first sensor, the first sensor having first physical characteristics, wherein a first slope and y-intercept of the first sensor is defined based on the first physical characteristics, wherein the sheet construction comprises a plurality of pre-sensors including the first pre-sensor, 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;

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

determining a representative slope and y-intercept, wherein the representative slope and y-intercept is based on the first slope and y-intercept;

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

when the representative slope and y-intercept is within the predetermined level of slopes and y-intercepts, physically modifying a second pre-sensor of the plurality of pre-sensors to form a second sensor that is separated from the sheet construction, the second sensor having the first physical characteristics;

or

when the representative 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 form a second sensor that is separated from the sheet construction, the second sensor having second physical characteristics, the second physical characteristics different than the first physical characteristics, wherein a slope and y-intercept of the second sensor is defined based on the second physical characteristics and is within the predetermined level of slopes and y-intercepts;

wherein physically modifying the second pre-sensor comprises modifying the sample chamber of the second pre-sensor.

41. The method of claim 40, wherein the representative slope and y-intercept is the first slope and y-intercept of the first sensor.

42. The method of claim 40, comprising:

separating one or more additional pre-sensors from the sheet construction to form one or more additional sensors, the one or more additional sensors having the first physical characteristics, wherein corresponding slopes and y-intercepts of the one or more additional sensors are defined based on the first physical characteristic; and

determining the corresponding slopes and y-intercepts of the one or more additional sensors;

wherein the representative slope and y-intercept is an average of the corresponding slopes and y-intercepts and the first slope and y-intercept.

43. The method of claim 40, wherein the first pre-sensor and the second pre-sensor are from a same sheet of a same lot of the sheet construction.

44. The method of claim 40, wherein the first pre-sensor and the second pre-sensor are from a different sheet of a same lot of the sheet construction.

45. The method of claim 40, wherein the physically modifying of the second pre-sensor comprises modifying an electrode area in a sample chamber.

46. The method of claim 40, comprising:

when the representative 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 form a third sensor that is separated from the sheet construction, the third sensor having the first physical characteristics.

47. The method of claim 40, comprising:

when the representative slope and y-intercept are within the predetermined level of slopes and y-intercepts, physically modifying a plurality of additional pre-sensors to form a plurality of additional sensors that are separated from the sheet construction, the plurality of additional sensors having the first physical characteristics, wherein the plurality of pre-sensors are from a same lot of the sheet construction and include the plurality of additional pre-sensors.

48. The method of claim 47, wherein the plurality of additional pre-sensors are from a same sheet of the same lot as the first pre-sensor and second pre-sensor.

49. The method of claim 47, wherein the plurality of additional pre-sensors are from a different sheet of the same lot as the first pre-sensor and second pre-sensor.

50. The method of claim 40, comprising:

when the representative slope and y-intercept deviates outside the predetermined level of slopes and y-intercepts, physically modifying a third pre-sensor of the plurality of pre-sensors to form a third sensor that is separated from the sheet construction, the third sensor having the second physical characteristics.

51. The method of claim 40, comprising:

when the representative slope and y-intercept deviates outside the predetermined level of slopes and y-intercepts, physically modifying a plurality of additional pre-sensors to form a plurality of additional sensors that are separated from the sheet construction, the plurality of additional sensors having the second physical characteristics, wherein the plurality of pre-sensors are from a same lot of the sheet construction and include the plurality of additional pre-sensors.

52. The method of claim 51, wherein the plurality of additional pre-sensors are from a same sheet of the same lot as the first pre-sensor.

53. The method of claim 51, wherein the plurality of additional pre-sensors are from a different sheet of the same lot as the first pre-sensor.

54. The method of claim 51, wherein the physically modifying of the second pre-sensor and the plurality of additional pre-sensors comprises modifying an electrode area in the sample chamber.

55. The method of claim 51, wherein the physically modifying of the second pre-sensor and the plurality of additional pre-sensors comprise modifying a volume of the sample chamber.

56. The method of claim 40, wherein when the representative slope and y-intercept deviates above the predetermined level of slopes and y-intercepts, the physically modifying of the sample chamber of the second pre-sensor comprises reducing an electrode area of the sample chamber.

57. The method of claim 40, wherein when the representative slope and y-intercept of the first sensor deviates above the predetermined level of slopes and y-intercepts, the physically modifying of the sample chamber of the second pre-sensor comprises reducing a volume of the sample chamber.

58. The method of claim 40, wherein the physically modifying of the second pre-sensor comprises modifying a volume of the sample chamber.