SENSORS

• US 20090211923A1
• Filed: 05/08/2009
• Published: 08/27/2009
• Est. Priority Date: 11/17/2005
• Status: Active Grant

• Current Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories)
• Original Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories)
• Inventors: Wang, Yi, Scott, Steve
• Granted Patent: US 7,967,962 B2
• Time in Patent Office: Days
• US Class Current: 205/787
• CPC Class Codes: B01L 2200/027 for microfluidic devices
• CPC Class Codes: B01L 2300/0825 Test strips
• CPC Class Codes: B01L 3/502715 characterised by interfacing components, e.g. fluidic, electrical, optical or mechanical interfaces
• CPC Class Codes: C12Q 1/001 Enzyme electrodes
• CPC Class Codes: C12Q 1/006 for glucose
• 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 33/525 Multi-layer analytical elements
• CPC Class Codes: G01N 33/526 the element being adapted for a specific analyte

Abstract

The subject invention provides devices and methods for the analysis of a body fluid. Embodiments include sensors that are sample-fillable by contacting a corner of the sensor to a sample.

Claims

1-37. -37. (canceled)

38. A sensor for determining the concentration of a ketone body in a sample of biological fluid, the sensor comprising:

a working electrode and a counter electrode; and

a sample chamber for receiving biological fluid and which sample chamber includes at least a portion of the working and counter electrodes,

wherein the sample chamber is adapted to receive the biological fluid by contacting a corner of the sensor with the biological fluid.

39. The sensor of claim 38, wherein the sensor is adapted to determine the concentration of an analyte using about 1 μ

L or less of sample in the sample chamber.

40. The sensor of claim 38, wherein the sample chamber is configured to contain no more than about 1 μ

L of sample.

41. The sensor of claim 38, wherein the corner is substantially rounded.

42. The sensor of claim 38, wherein the corner is substantially squared.

43. A sensor for determining the concentration of a ketone body in a biological fluid sample, the sensor comprising:

a sample chamber adapted to determine the concentration of a ketone body in less than about 1 μ

L of sample;

one or more chamber openings for admitting sample to the chamber; and

at least one corner, wherein at least one of the sample chamber openings is positioned about at least one corner of the sensor.

44. The sensor of claim 43, wherein the sample chamber comprises first and second channel openings and a first chamber opening comprises is positioned about a first sensor corner and the second chamber opening is positioned about a second sensor corner.

45. The sensor of claim 43, wherein the sensor is formed in a substantially rectangular shape.

46. The sensor of claim 43, wherein the sensor is adapted to determine the concentration of a ketone body using about 0.5 μ

L or less of sample in the sample chamber.

47. The sensor of claim 46, wherein the sensor is adapted to determine the concentration of a ketone body using about 0.2 μ

L or less of sample in the sample chamber.

48. The sensor of claim 46, wherein the sensor is adapted to determine the concentration of a ketone body using about 0.1 μ

L or less of sample in the sample chamber.

49. The sensor of claim 43, wherein the sample chamber is configured to contain no more than about 1 μ

L of sample.

50. The sensor of claim 49, wherein the sample chamber is configured to contain no more than about 0.5 μ

L of sample.

51. The sensor of claim 50, wherein the sample chamber is configured to contain no more than about 0.2 μ

L of sample.

52. The sensor of claim 51, wherein the sample chamber is configured to contain no more than about 0.1 μ

L of sample.

53. The sensor of claim 43, wherein the sensor is an electrochemical sensor.

54. The sensor of claim 43, wherein the sensor is an optical sensor.

55. The sensor of claim 43, wherein the sensor comprises a first edge operatively connectable with a meter, and a second edge substantially opposite the first end and comprising the one or more sample chamber openings.

56. The sensor of claim 55, wherein an edge of the sample chamber is substantially parallel to the second edge.

57. The sensor of claim 56, wherein the distance between a sample chamber edge and the second edge ranges from about 0.01 mm to about 1.5 mm.

58. A ketone body sensor comprising:

a first substrate separated from a second substrate by a spacer layer and including at least one electrode, the first and second substrates forming a sensor comprising first and second opposing side edges and third and fourth opposing side edges; and

a sample admitting port at an intersection of any two edges of the sensor.

59. The sensor of claim 58, wherein the first edge intersects edges three and four and the second edge intersects edges three and four, and a sample admitting port is positioned about an intersection of the first and third edges, or an intersection of the first and fourth edges, or a sample filling port at an intersection of the first and third edges and an intersection of the first and fourth edges.

60. A method for determining a ketone body concentration in a sample of biological fluid, the method comprising:

operatively connecting an analyte sensor with a meter;

applying, after connecting the sensor to the meter, an ketone body-containing sample to a corner-fill analyte sensor by contacting a sample admitting opening positioned about a corner of the sensor with the sample; and

determining the concentration of a ketone body in the sample.

61. The method of claim 60, wherein the concentration of the ketone body is determined using about 1 μ

L or less of sample in the sample chamber.

62. The method of claim 61, wherein the concentration of the ketone body is determined using about 0.5 μ

L or less of sample in the sample chamber.

63. The method of claim 62, wherein the concentration of the ketone body is determined using about 0.2 μ

L or less of sample in the sample chamber.

64. The method of claim 63, wherein the concentration of the ketone body is determined using about 0.1 μ

L or less of sample in the sample chamber.

65. The method of claim 60, wherein the sample chamber is sized to contain no more than about 1 μ

L of sample.

66. The method of claim 60, wherein the ketone body concentration is determined using photometry.

67. The method of claim 60, wherein the determining comprises a measurement technique involving an electrochemical measurement in the sensor.

68. The method of claim 67, wherein the measurement technique comprises amperometry.

69. The method of claim 67, wherein the measurement technique comprises coulometry.

70. The method of claim 67, wherein the measurement technique comprises potentiometry.

71. The method of claim 67, wherein the measurement technique comprises impedance measurement.

72. An integrated device for determining the concentration of a ketone body in a sample, the system comprising:

a housing comprising a corner-fill analyte sensor and a processor adapted for determining the concentration of a ketone body in a sample applied to the corner-fill analyte sensor.