ANALYTE SENSORS AND METHODS OF USE

• US 20090240166A1
• Filed: 05/08/2009
• Published: 09/24/2009
• Est. Priority Date: 03/29/2006
• 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., Watkin, Jared L.
• Granted Patent: US 8,083,927 B2
• Time in Patent Office: Days
• US Class Current: 600/583
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/14546 for measuring analytes not otherwise provided for, e.g. ions, cytochromes
• CPC Class Codes: A61B 5/1486 using enzyme electrodes, e.g. with immobilised oxidase
• 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: Y10T 436/200833 Carbonyl, ether, aldehyde or ketone containing

Abstract

In vitro analyte sensors and methods of analyte determination are provided. Embodiments include sensors that include a pair of electrodes to monitor filling of the sample chamber with sample.

Claims

1-29. -29. (canceled)

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

a sample chamber;

a first electrode pair spaced in a lateral direction with respect to each other in the sample chamber, and

a second electrode pair spaced in a longitudinal direction with respect to each other in the sample chamber.

31. The sensor of claim 30, wherein about 10% to about 95% of the perimeter of the sample chamber is unbounded.

32. The sensor of claim 31, wherein about 50% to about 95% of the perimeter of the sample chamber is unbounded.

33. The sensor of claim 30, wherein the sample chamber comprises at least two unbounded sides.

34. The sensor of claim 33, wherein the sample chamber comprises three unbounded sides.

35. The sensor of claim 30, wherein the sample chamber has a volume of no more than about 1 microliter.

36. The sensor of claim 35, wherein the sample chamber has a volume of no more than about 0.5 microliter.

37. The sensor of claim 36, wherein the sample chamber has a volume of no more than about 0.1 microliter.

38. The sensor of claim 30, wherein the sensor comprises a first substrate and a second substrate, a spacer between the first substrate and the second substrate, together the first substrate, second substrate and spacer defining at least a portion of the sample chamber.

39. The sensor of claim 38, wherein the first electrode pair and the second electrode pair are on the first substrate.

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

a sample chamber configured for multi-directional fill; and

a first electrode arrangement and a second electrode arrangement on a surface within the sample chamber, the first electrode arrangement being a pair of indicator electrodes.

41. The sensor of claim 40, wherein the second electrode arrangement comprises a pair of counter electrodes, and the sensor further comprising a working electrode on a second surface within the sample chamber.

42. The sensor of claim 40, wherein the second electrode arrangement comprises a pair of working electrodes, and wherein the first electrode arrangement is a pair of co-functional indicator/counter electrodes.

43. The sensor of claim 40, wherein the second electrode arrangement comprises a pair of counter electrodes, and wherein the first electrode arrangement is a pair of co-functional indicator/working electrodes.

44. The sensor of claim 40, wherein the second electrode arrangement comprises a single electrode.

45. The sensor of claim 40, wherein about 10% to about 95% of the perimeter of the sample chamber is unbounded.

46. The sensor of claim 45, wherein about 50% to about 95% of the perimeter of the sample chamber is unbounded.

47. The sensor of claim 40, wherein the sample chamber comprises at least two unbounded sides.

48. The sensor of claim 47, wherein the sample chamber comprises three unbounded sides.

49. The sensor of claim 40, wherein the sample chamber has a volume of no more than about 1 microliter.

50. The sensor of claim 49, wherein the sample chamber has a volume of no more than about 0.5 microliter.

51. The sensor of claim 50, wherein the sample chamber has a volume of no more than about 0.1 microliter.

52. The sensor of claim 40, wherein the sensor comprises a first substrate and a second substrate, a spacer between the first substrate and the second substrate, together the first substrate, second substrate and spacer defining at least a portion of the sample chamber.

53. An integrated system for the determination of a ketone body in biological fluid, the system comprising:

a housing having an interior space;

at least one sensor for determining the concentration of an ketone body in a sample positioned in the interior space, the sensor comprising a sample chamber configured for multi-directional fill, and at least a first electrode arrangement and a second electrode arrangement on a surface; and

a processor for determining the concentration of a ketone body applied to a sensor.

54. The integrated system of claim 53, further comprising a skin-piercing element.

55. A method of analyzing a ketone body in a biological fluid sample, the method comprising:

contacting an inlet region of a biosensor having multi-directional fill capabilities with the sample to provide sample into a sample chamber of the sensor;

contacting a first electrode arrangement and a second electrode arrangement with the sample in the sample chamber;

determining if the sample if sufficient filled; and

analyzing of the ketone body.

56. A method of analyzing a ketone body in a biological fluid sample, the method comprising:

contacting an inlet region of a biosensor having multi-directional fill capabilities with the sample to provide sample into a sample chamber of the sensor;

contacting an indicator electrode pair with the sample in the sample chamber; and

after contacting each electrode of the indicator electrode pair with the sample, beginning analysis of the ketone body at a second electrode arrangement.

57. The method of claim 56, wherein the second electrode arrangement comprises a first electrode and a second electrode, and the method further comprises comparing signals from the first electrode and the second electrode to surface areas of the first electrode and the second electrode.

58. The method of claim 57, further comprising discarding the reading if a relation of the signals is not within acceptable tolerance to a relation of the surface areas.