System and Methods for Determining an Analyte Concentration Incorporating a Hematocrit Correction

• US 20080083618A1
• Filed: 08/28/2007
• Published: 04/10/2008
• Est. Priority Date: 09/05/2006
• Status: Abandoned Application

• Current Assignee: Nipro Diagnostics, Inc.
• Original Assignee: Nipro Diagnostics, Inc.
• Inventors: Bell, Douglas, Deng, David, Slomski, Dennis, Neel, Gary
• Application Number:
  US11/845,860
• Publication Number:
  US 20080083618A1
• Time in Patent Office: Days
• US Class Current: 204/403.14
• CPC Class Codes: A61B 2560/0209 adapted for power saving
• CPC Class Codes: A61B 2562/0295 Strip shaped analyte sensors for apparatus classified in A61B5/145 or A61B5/157 disposable multilayered or laminated electrodes G01N27/307; details of handling chemical test elements G01N33/4875
• CPC Class Codes: A61B 2562/085 combined with means for recording calibration data
• CPC Class Codes: A61B 5/14535 for measuring haematocrit
• 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: 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 27/3274 Corrective measures, e.g. error detection, compensation for temperature or hematocrit, calibration coding of calibration information G01N33/48771
• CPC Class Codes: G01N 33/66 involving blood sugars, e.g. galactose
• CPC Class Codes: Y10T 29/49117 Conductor or circuit manufacturing

Abstract

Methods and devices for determining the concentration of a constituent in a physiological sample are provided. The blood sample is introduced into a test strip with portions of the blood sample being directed to both a first capillary and a second capillary. The first capillary configured to electrochemically determine a concentration of a first analyte in a blood sample by measuring a signal across a set of electrodes. The second capillary is configured to determine a hematocrit value of the blood sample by measuring a signal across a second set of electrodes.

Claims

1. A biosensor, comprising:

a base layer;

a first capillary disposed on the base layer configured to electrochemically determine a concentration of a first analyte in a blood sample, wherein the first capillary includes a first set of at least one electrode; and

a second capillary disposed on the base layer configured to determine a value correlating to the hematocrit level of the blood sample, wherein the second capillary includes a second set of at least one electrode.

2. The biosensor of claim 1, wherein an exit port of the first capillary is fluidly connected to an entry port of the second capillary.

3. The biosensor of claim 1, wherein an entry port of the first capillary is fluidly connected to an entry port of the second capillary.

4. The biosensor of claim 1, further including a third capillary configured to permit determination of a third parameter associated with the blood sample, wherein the third capillary includes a third set of electrodes.

5. The biosensor of claim 4, wherein an entry port of the first capillary is fluidly connected to an entry port of the second capillary and fluidly connected to an entry port of the third capillary.

6. The biosensor of claim 4, wherein the third parameter is selected from a group consisting of a temperature, a concentration of a second analyte, and an on-board control.

7. The biosensor of claim 1, wherein the first capillary further includes a reagent layer.

8. The biosensor of claim 7, wherein the reagent layer includes at least one of glucose oxidase, glucose dehydrogenase, potassium ferricyanide, and ruthenium hexamine.

9. The biosensor of claim 7, wherein the reagent layer is deposited using a process selected from the group consisting of screen-printing, spray deposition, piezo, pipetting, and ink jet printing.

10. The biosensor of claim 1, wherein the first set of electrodes includes at least one of a working electrode, a proximal electrode, and a fill-detect electrode.

11. The biosensor of claim 1, wherein the first set of electrodes and the second set of electrodes share the at least one electrode.

12. The biosensor of claim 1, further including at least one of an electrical contact, an auto-on conductor, and a coding region.

13. The biosensor of claim 12, wherein an at least partially conductive layer at least partially covers at least one of the electrical contact, the auto-on conductor, and the coding region.

14. The biosensor of claim 1, wherein the at least one electrode is at least partially formed from at least one of palladium, gold, platinum, silver, iridium, carbon, indium tin oxide, indium zinc oxide, copper, aluminum, gallium, iron, mercury amalgams, tantalum, titanium, zirconium, nickel, osmium, rhenium, rhodium palladium, an organometallic, and a metallic alloy.

15. The biosensor of claim 1, wherein the at least one electrode is at least partially formed using at least one process selected from the group consisting of sputtering, evaporation, electroplating, ultrasonic spraying, pressure spraying, direct writing, shadow mask lithography, lift-off lithography, and laser ablation.

16. The biosensor of claim 1, wherein the biosensor includes a generally planar base layer.

17. The biosensor of claim 16, wherein the generally planar base layer includes at least one of an acrylic and a polyester.

18. The biosensor of claim 1, wherein the biosensor further includes a dielectric spacer layer at least partially deposited on the at least one electrode.

19. The biosensor of claim 18, wherein the dielectric spacer layer includes at least one of an acrylic and a polyester.

20. The biosensor of claim 18, wherein the biosensor further includes an adhesive layer disposed between the dielectric spacer layer and the at least one electrode.

21. The biosensor of claim 1, further including a second plurality of electrical contacts that include a code with data relating to the biosensor.

22. An analyte testing system, comprising:

a meter system for making a measurement of an analyte concentration in a sample, wherein the meter system is configured to use the biosensor of claim 1.

23. The analyte testing system of claim 22, wherein the meter system utilizes the determined hematocrit value to enhance calculating the concentration of the first analyte.

24. A method for manufacturing a biosensor, comprising:

at least partially forming a plurality of electrodes on a generally planar base layer;

forming a first capillary on the base layer, wherein the first capillary includes a first set of at least one electrode selected from the plurality of at least partially formed electrodes; and

forming a second capillary on the base layer, wherein the second capillary includes a second set of at least one electrode selected from the plurality of at least partially formed electrodes.

25. The method of claim 24, wherein an exit port of the first capillary is fluidly connected to an entry port of the second capillary.

26. The method of claim 24, wherein an entry port of the first capillary is fluidly connected to an entry port of the second capillary.

27. The method of claim 24, further including a third capillary configured to permit determination of a third parameter associated with the blood sample, wherein the third capillary includes a third set of electrodes.

28. The method of claim 27, wherein an entry port of the first capillary is fluidly connected to an entry port of the second capillary and fluidly connected to an entry port of the third capillary.

29. The method of claim 27, wherein the third parameter is selected from a group consisting of a temperature, a concentration of a second analyte, and an on-board control.

30. The method of claim 24, wherein the first capillary further includes a reagent layer.

31. The method of claim 30, wherein the reagent layer includes at least one of glucose oxidase, glucose dehydrogenase, potassium ferricyanide, and ruthenium hexamine.

32. The method of claim 30, wherein the reagent layer is deposited using a process selected from the group consisting of screen-printing, spray deposition, piezo, pipetting, and ink jet printing.

33. The method of claim 24, wherein the first set of electrodes includes at least one of a working electrode, a proximal electrode, and a fill-detect electrode.

34. The method of claim 24, wherein the first set of electrodes and the second set of electrodes share the at least one electrode.

35. The method of claim 24, further including at least one of an electrical contact, an auto-on conductor, and a coding region.

36. The method of claim 35, wherein an at least partially conductive layer at least partially covers at least one of the electrical contact, the auto-on conductor, and the coding region.

37. The method of claim 24, wherein the at least one electrode is at least partially formed from at least one of palladium, gold, platinum, silver, iridium, carbon, indium tin oxide, indium zinc oxide, copper, aluminum, gallium, iron, mercury amalgams, tantalum, titanium, zirconium, nickel, osmium, rhenium, rhodium palladium, an organometallic, and a metallic alloy.

38. The method of claim 24, wherein the at least one electrode is at least partially formed using at least one process selected from the group consisting of sputtering, evaporation, electroplating, ultrasonic spraying, pressure spraying, direct writing, shadow mask lithography, lift-off lithography, and laser ablation.

39. The method of claim 24, wherein the generally planar base layer includes at least one of an acrylic and a polyester.

40. The method of claim 24, wherein the biosensor further includes a dielectric spacer layer at least partially deposited on the at least one electrode.

41. The method of claim 40, wherein the dielectric spacer layer includes at least one of an acrylic and a polyester.

42. The method of claim 40, wherein the biosensor further includes an adhesive layer disposed between the dielectric spacer layer and the at least one electrode.

43. The method of claim 24, further including a second plurality of electrical contacts that include a code with data relating to the biosensor.

44. An analyte testing system comprising a meter system for making a measurement of an analyte concentration in a sample, the meter utilizing the biosensor of claim 24.

45. The analyte testing system of claim 44, wherein the meter system utilizes the determined hematocrit value to enhance calculating the concentration of the first analyte.

46. A reel for manufacturing biosensors, comprising:

a generally planar base layer including a plurality of at least partially formed electrodes;

a first capillary on the base layer, wherein the first capillary includes a first set of at least one electrode selected from the plurality of at least partially formed electrodes; and

a second capillary on the base layer, wherein the second capillary includes a second set of at least one electrode selected from the plurality of at least partially formed electrodes.

47. The reel of claim 46, further including a plurality of registration points formed on the generally planar base layer.

48. The reel of claim 46, wherein the plurality of registration points are used to help align the base layer during at least one of the lamination, punching, etching, scoring, drilling, heating, compression, molding, printing, laser ablation of conductive components, reagent deposition, or singulation processes.

49. The reel of claim 46, wherein the plurality of registration points are separated by less than 500 mm.

50. The reel of claim 46, wherein at least one of the plurality of registration points is less than 10 mm wide.

51. The reel of claim 46, wherein an exit port of the first capillary is fluidly connected to an entry port of the second capillary.

52. The reel of claim 46, wherein an entry port of the first capillary is fluidly connected to an entry port of the second capillary.

53. The reel of claim 46, further including a third capillary configured to permit determination of a third parameter associated with the blood sample, wherein the third capillary includes a third set of electrodes.

54. The reel of claim 53, wherein an entry port of the first capillary is fluidly connected to an entry port of the second capillary and fluidly connected to an entry port of the third capillar.

55. The reel of claim 53, wherein the third parameter is selected from a group consisting of a temperature, a concentration of a second analyte, and an on-board control.

56. The reel of claim 46, wherein the first capillary further includes a reagent layer.

57. The reel of claim 56, wherein the reagent layer includes at least one of glucose oxidase, glucose dehydrogenase, potassium ferricyanide, and ruthenium hexamine.

58. The reel of claim 56, wherein the reagent layer is deposited using a process selected from the group consisting of screen-printing, spray deposition, piezo, pipetting, and ink jet printing.

59. The reel of claim 46, wherein the first set of electrodes includes at least one of a working electrode, a proximal electrode, and a fill-detect electrode.

60. The reel of claim 46, wherein the first set of electrodes and the second set of electrodes share the at least one electrode.

61. The reel of claim 46, further including at least one of an electrical contact, an auto-on conductor, and a coding region.

62. The reel of claim 61, wherein an at least partially conductive layer at least partially covers at least one of the electrical contact, the auto-on conductor, and the coding region.

63. The reel of claim 46, wherein the at least one electrode is at least partially formed from at least one of palladium, gold, platinum, silver, iridium, carbon, indium tin oxide, indium zinc oxide, copper, aluminum, gallium, iron, mercury amalgams, tantalum, titanium, zirconium, nickel, osmium, rhenium, rhodium palladium, an organometallic, and a metallic alloy.

64. The reel of claim 46, wherein the at least one electrode is at least partially formed using at least one process selected from the group consisting of sputtering, evaporation, electroplating, ultrasonic spraying, pressure spraying, direct writing, shadow mask lithography, lift-off lithography, and laser ablation.

65. The reel of claim 46, wherein the generally planar base layer includes at least one of an acrylic and a polyester.

66. The reel of claim 46, wherein the biosensor further includes a dielectric spacer layer at least partially deposited on the at least one electrode.

67. The reel of claim 66, wherein the dielectric spacer layer includes at least one of an acrylic and a polyester.

68. The reel of claim 66, wherein the biosensor further includes an adhesive layer disposed between the dielectric spacer layer and the at least one electrode.

69. The reel of claim 46, further including a second plurality of electrical contacts that include a code with data relating to the reel.

70. An analyte testing system comprising a meter system for making a measurement of an analyte concentration in a sample, the meter utilizing the biosensors of claim 46.

71. The analyte testing system of claim 70, wherein the meter system utilizes the determined hematocrit value to enhance calculating the concentration of the first analyte.

72. A method of manufacturing a plurality of test strips for a biosensor, comprising:

forming a reel containing a base layer;

forming a plurality of electrodes on the base layer; and

partially forming a test strip, wherein the test strip includes a first capillary on the base layer including at least one of the plurality of electrodes and the test strip further includes a second capillary on the base layer including at least one of the plurality of electrode.

73. The method of claim 72, wherein the reel includes a plurality of registration points.

74. The method of claim 72, wherein an exit port of the first capillary is fluidly connected to an entry port of the second capillary.

75. The method of claim 72, wherein an entry port of the first capillary is fluidly connected to an entry port of the second capillary.

76. The method of claim 72, further including a third capillary configured to permit determination of a third parameter associated with the blood sample, wherein the third capillary includes a third set of electrodes.

77. The method of claim 76, wherein an entry port of the first capillary is fluidly connected to an entry port of the second capillary and fluidly connected to an entry port of the third capillary.

78. The method of claim 76, wherein the third parameter is selected from a group consisting of a temperature, a concentration of a second analyte, and an on-board control.

79. The method of claim 72, wherein the first capillary further includes a reagent layer.

80. The method of claim 79, wherein the reagent layer includes at least one of glucose oxidase, glucose dehydrogenase, potassium ferricyanide, and ruthenium hexamine.

81. The method of claim 79, wherein the reagent layer is deposited using a process selected from the group consisting of screen-printing, spray deposition, piezo, pipetting, and ink jet printing.

82. The method of claim 72, wherein the first set of electrodes includes at least one of a working electrode, a proximal electrode, and a fill-detect electrode.

83. The method of claim 72, wherein the first set of electrodes and the second set of electrodes share the at least one electrode.

84. The method of claim 72, further including at least one of an electrical contact, an auto-on conductor, and a coding region.

85. The method of claim 84, wherein an at least partially conductive layer at least partially covers at least one of the electrical contact, the auto-on conductor, and the coding region.

86. The method of claim 72, wherein the at least one electrode is at least partially formed from at least one of palladium, gold, platinum, silver, iridium, carbon, indium tin oxide, indium zinc oxide, copper, aluminum, gallium, iron, mercury amalgams, tantalum, titanium, zirconium, nickel, osmium, rhenium, rhodium palladium, an organometallic, and a metallic alloy.

87. The method of claim 72, wherein the at least one electrode is at least partially formed using at least one process selected from the group consisting of sputtering, evaporation, electroplating, ultrasonic spraying, pressure spraying, direct writing, shadow mask lithography, lift-off lithography, and laser ablatio.

88. The method of claim 72, wherein the biosensor includes a generally planar base layer.

89. The method of claim 88, wherein the generally planar base layer includes at least one of an acrylic and a polyester.

90. The method of claim 72, wherein the biosensor further includes a dielectric spacer layer at least partially deposited on the at least one electrode.

91. The method of claim 90, wherein the dielectric spacer layer includes at least one of an acrylic and a polyester.

92. The method of claim 90, wherein the biosensor further includes an adhesive layer disposed between the dielectric spacer layer and the at least one electrode.

93. The method of claim 72, further including a second plurality of electrical contacts that include a code with data relating to the plurality of test strips.

94. An analyte testing system comprising a meter system for making a measurement of an analyte concentration in a sample, the meter utilizing the biosensor of claim 72.

95. The analyte testing system of claim 94, wherein the meter system utilizes the determined hematocrit value to enhance calculating the concentration of the first analyte.

96. A test card for quality control analysis of biosensors, comprising:

a base layer, wherein the base layer includes a plurality of electrodes;

a plurality of partially formed test strips, wherein each test strip includes a first capillary on the base layer including at least one of the plurality of electrodes and each test strip further includes a second capillary on the base layer including at least one of the plurality of electrodes.

97. The test card of claim 96, wherein an exit port of the first capillary is fluidly connected to an entry port of the second capillary.

98. The test card of claim 96, wherein an entry port of the first capillary is fluidly connected to an entry port of the second capillary.

99. The test card of claim 96, further including a third capillary configured to permit determination of a third parameter associated with the blood sample, wherein the third capillary includes a third set of electrodes.

100. The test card of claim 99, wherein an entry port of the first capillary is fluidly connected to an entry port of the second capillary and fluidly connected to an entry port of the third capillary.

101. The test card of claim 99, wherein the third parameter is selected from a group consisting of a temperature, a concentration of a second analyte, and an on-board control.

102. The test card of claim 96, wherein the first capillary further includes a reagent layer.

103. The test card of claim 102, wherein the reagent layer includes at least one of glucose oxidase, glucose dehydrogenase, potassium ferricyanide, and ruthenium hexamine.

104. The test card of claim 102, wherein the reagent layer is deposited using a process selected from the group consisting of screen-printing, spray deposition, piezo, pipetting, and ink jet printing.

105. The test card of claim 96, wherein the first set of electrodes includes at least one of a working electrode, a proximal electrode, and a fill-detect electrode.

106. The test card of claim 96, wherein the first set of electrodes and the second set of electrodes share the at least one electrode.

107. The test card of claim 96, further including at least one of an electrical contact, an auto-on conductor, and a coding region.

108. The test card of claim 107, wherein an at least partially conductive layer at least partially covers at least one of the electrical contact, the auto-on conductor, and the coding region.

109. The test card of claim 96, wherein the at least one electrode is at least partially formed from at least one of palladium, gold, platinum, silver, iridium, carbon, indium tin oxide, indium zinc oxide, copper, aluminum, gallium, iron, mercury amalgams, tantalum, titanium, zirconium, nickel, osmium, rhenium, rhodium palladium, an organometallic, and a metallic alloy.

110. The test card of claim 96, wherein the at least one electrode is at least partially formed using at least one process selected from the group consisting of sputtering, evaporation, electroplating, ultrasonic spraying, pressure spraying, direct writing, shadow mask lithography, lift-off lithography, and laser ablation.

111. The test card of claim 96, wherein the biosensor includes a generally planar base layer.

112. The test card of claim 111, wherein the generally planar base layer includes at least one of an acrylic and a polyester.

113. The test card of claim 96, wherein the biosensor further includes a dielectric spacer layer at least partially deposited on the at least one electrode.

114. The test card of claim 113, wherein the dielectric spacer layer includes at least one of an acrylic and a polyester.

115. The test card of claim 113, wherein the biosensor further includes an adhesive layer disposed between the dielectric spacer layer and the at least one electrode.

116. The test card of claim 96, further including a second plurality of electrical contacts that include a code with data relating to the biosensor.

117. An analyte testing system comprising;

a meter system for making a measurement of an analyte concentration in a sample, wherein the meter system is configured to use at least one of the plurality of partially formed test strips of claim 96.

118. The analyte testing system of claim 117, wherein the meter system utilizes the determined hematocrit value to enhance calculating the concentration of the first analyte.