Biosensor with multiple electrical functionalities

• US 20050023137A1
• Filed: 06/18/2004
• Published: 02/03/2005
• Est. Priority Date: 06/20/2003
• Status: Active Grant

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diagnostics Operations Incorporated (Roche Holding AG)
• Inventors: Buck, Harvey B. Jr., Beaty, Terry A., Diebold, Eric R., Hill, Brian S., Burke, David W., Bhullar, Raghbir S., Walling, Paul Douglas
• Granted Patent: US 7,867,369 B2
• Time in Patent Office: Days
• US Class Current: 204/403.100
• CPC Class Codes: C12M 1/00 Apparatus for enzymology or microbiology
• CPC Class Codes: C12Q 1/001 Enzyme electrodes
• CPC Class Codes: G01N 27/3272 Test elements therefor, i.e. disposable laminated substrates with electrodes, reagent and channels optical biosensors G01N33/52

Abstract

A biosensor having multiple electrical functionalities located both within and outside of the measurement zone in which a fluid sample is interrogated. Incredibly small and complex electrical patterns with high quality edges provide electrical functionalities in the biosensor and also provide the electrical wiring for the various other electrical devices provided in the inventive biosensor. In addition to a measurement zone with multiple and various electrical functionalities, biosensors of the present invention may be provided with a user interface zone, a digital device zone and/or a power generation zone. The inventive biosensors offer improved ease of use and performance, and decrease the computational burden and associated cost of the instruments that read the biosensors by adding accurate yet cost-effective functionalities to the biosensors themselves.

Claims

1. A biosensor for analyzing a fluid sample, comprising:

a biosensor body;

the biosensor body defining a measurement zone having a sample receiving chamber in which is disposed a measurement electrode for detecting the presence or concentration of an analyte in the fluid sample, the sample receiving chamber including a reagent which reacts with the fluid sample; and

the biosensor body further defining a user interface zone in which is disposed an electrically driven signal generator which emits a visible, audible or tactile signal upon occurrence of a triggering event.

2. The biosensor of claim 1, wherein the signal generator comprises a light which illuminates a portion of the test strip upon the occurrence of the triggering event.

3. The biosensor of claim 1, wherein the signal generator comprises a light disposed proximate the sample receiving chamber, the light illuminating the sample receiving chamber upon the occurrence of the triggering event.

4. The biosensor of claim 1, wherein the signal generator comprises a numerical display corresponding to the concentration of an analyte in the fluid sample.

5. The biosensor of claim 1, wherein the signal comprises sound.

6. The biosensor of claim 1, wherein the signal generator comprises an OLED.

7. The biosensor of claim 6, further comprising a micro-electrode set disposed on a substantially planar surface of the biosensor body, the OLED being coated onto the micro-electrode set.

8. The biosensor of claim 1, wherein the signal generator comprises an LED.

9. The biosensor of claim 1, wherein the signal generator comprises a piezoelectric wafer, wherein the signal is audible.

10. The biosensor of claim 1, wherein the biosensor body further comprises a digital information zone in which is disposed a digital device.

11. The biosensor of claim 10, wherein the digital device comprises an electrical pattern encoded with at least one parameter about the biosensor.

12. The biosensor of claim 10, wherein the digital device comprises an integrated circuit.

13. The biosensor of claim 10, wherein the digital device comprises an RFID tag.

14. The biosensor of claim 10, wherein the digital device is encoded with the type of analyte the biosensor is configured to analyze.

15. The biosensor of claim 10, wherein the digital device is encoded with at least one of a lot code and an expiration date of the biosensor.

16. The biosensor of claim 1, wherein the biosensor body further defines a power generating zone in which is disposed a power generator.

17. The biosensor of claim 16, wherein the power generator is electrically connected to the signal generator and provides power thereto upon the occurrence of the triggering event.

18. The biosensor of claim 16, wherein the power generator comprises a battery.

19. The biosensor of claim 18, wherein the battery comprises a thin film.

20. The biosensor of claim 16, wherein the power generator comprises a capacitor that discharges upon the occurrence of the triggering event.

21. The biosensor of claim 16, wherein the power generator generates at least 2 volts for at least 2 seconds upon the occurrence of the triggering event.

22. The biosensor of claim 1, wherein the measurement zone comprises a dose sufficiency electrode.

23. The biosensor of claim 1, further comprising:

a first set of electrodes at least partially disposed in the sample receiving chamber for estimating the concentration of an analyte in the sample, the first set of electrodes including the measurement electrode; and

a second set of electrodes at least partially disposed in the sample receiving chamber.

24. The biosensor of claim 23, wherein the second set of electrodes comprises a pair of electrodes with substantially parallel, interdigitated fingers, each electrode having at least two fingers.

25. The biosensor of claim 1, wherein the sample receiving chamber has a volume of less than about 250 nl.

26. The biosensor of claim 1, wherein the sample receiving chamber has a volume of less than about 100 nl.

27. The biosensor of claim 1, wherein the reagent covers the measurement electrode.

28. A biosensor for analyzing a fluid sample, comprising:

a biosensor body;

a measurement zone disposed in or on the biosensor body in which the fluid sample is received and analyzed; and

a power generator disposed in or on the biosensor body.

29. The biosensor of claim 28, wherein the power generator comprises a battery.

30. The biosensor of claim 29, wherein the biosensor body defines a substantially planar substrate and the battery comprises a thin film adhered to the substrate.

31. The biosensor of claim 28, wherein the power generator comprises a capacitor.

32. The biosensor of claim 28, wherein the measurement zone comprises a sample receiving chamber in which is disposed a sample sufficiency electrode which is electrically connected to the power generator.

33. The biosensor of claim 28, wherein the biosensor body further defines a user interface zone in which is disposed an electrically driven signal generator which emits a visible, audible or tactile signal upon occurrence of a triggering event.

34. The biosensor of claim 33, wherein the biosensor body further defines a digital information zone in which is disposed a digital device.

35. The biosensor of claim 34, wherein the digital device comprises an electrical pattern encoded with information about the biosensor.

36. The biosensor of claim 28, wherein the biosensor body further defines a digital information zone in which is disposed a digital device.

37. The biosensor of claim 36, wherein the digital device comprises an electrical pattern encoded with information about the biosensor.

38. The biosensor of claim 28, wherein the measurement zone comprises a sample receiving chamber in which is disposed a reagent at least partially covering an electrode set for estimating the concentration of an analyte contained in the fluid sample.

39. The biosensor of claim 38, further comprising a second electrode set at least partially disposed within the sample receiving chamber.

40. The biosensor of claim 38, wherein the sample receiving chamber includes a sample sufficiency electrode.

41. The biosensor of claim 28, wherein the biosensor defines a substantially planar substrate on which is formed an electrical pattern extending into the measurement zone and power generation zone.

42. The biosensor of claim 41, further comprising at least one spacer or covering layer overlying the substantially planar substrate, the at least one spacer or covering layer having a void that defines a sample receiving chamber disposed in the measurement zone.

43. The biosensor of claim 42, wherein the sample receiving chamber includes a first electrode set which is covered by a reagent and which is electrically connected to the electrical pattern.

44. The biosensor of claim 43, further comprising a second electrode set disposed within the sample receiving chamber.

45. A biosensor for analyzing a fluid sample, comprising:

a biosensor body;

the biosensor body defining a sample receiving chamber having a fluid receiving opening for receiving the fluid sample;

at least four electrical devices positioned on or in the biosensor body, the electrical devices comprising one or more electrodes, power generators, digital devices or electrically driven signal generators; and

wherein two of the at least four electrical devices comprise first and second sets of electrodes disposed at least partially within the sample receiving chamber, one of the first and second sets of electrodes determining the presence or estimating the concentration of an analyte in the fluid sample.

46. The biosensor of claim 45, wherein all four electrical devices comprise electrode sets disposed at least partially within the sample receiving chamber.

47. The biosensor of claim 46, wherein each of the four electrode sets comprises the same functionality.

48. The biosensor of claim 46, wherein the sample receiving chamber has a volume of less than about 130 nl.

49. The biosensor of claim 46, wherein the four electrode sets comprises at least two different functionalities.

50. The biosensor of claim 46, wherein the four electrode sets comprises at least three different electrode functionalities.

51. The biosensor of claim 46, wherein the four electrode sets comprises four different electrode functionalities.

52. The biosensor of claim 46, wherein all four electrode sets are substantially the same.

53. The biosensor of claim 46, wherein at least one of the electrode sets comprises a macro-electrode set and at least one other of the electrode sets comprises a micro-electrode set.

54. The biosensor of claim 45, wherein one of the electrical devices comprises a sample sufficiency electrode set in electrical communication with the sample receiving chamber.

55. The biosensor of claim 45, wherein one of the electrical devices comprises a third set of electrodes at least partially disposed within the sample receiving chamber for determining a correction factor for analyte concentration based on the detection of interferents in the fluid sample.

56. The biosensor of claim 45, wherein the biosensor body further defines a user interface zone and one of the electrical devices comprises an electrically driven signal generator disposed in the user interface zone which ernits a visible, audible or tactile signal upon occurrence of a triggering event.

57. The biosensor of claim 56, wherein the signal generator comprises a light.

58. The biosensor of claim 57, wherein the signal generator comprises an OLED coated on an electrode set.

59. The biosensor of claim 58, wherein the electrode set comprises a micro-electrode array.

60. The biosensor of claim 59, wherein the micro-electrode set comprises substantially parallel, interdigitated fingers, each electrode of the micro-electrode set having at least two fingers.

61. The biosensor of claim 45, wherein one of the electrical devices comprises an electrode pattern encoded with digital information about the biosensor.

62. The biosensor of claim 61, wherein the digital information comprises lot code, expiration date or type of analyte.

63. The biosensor of claim 62, wherein the digital information comprises lot code and expiration date.

64. The biosensor of claim 45, wherein one of the electrical devices comprises a power generator.

65. The biosensor of claim 64, wherein the power generator comprises a battery.

66. The biosensor of claim 65, wherein one of the electrical devices comprises an electrically driven signal generator.

67. The biosensor of claim 45, wherein the sample receiving chamber comprises first and second branches, the first electrode set being disposed in the first branch and the second electrode set being disposed in the second branch.

68. The biosensor of claim 67, wherein at least one of the first and second branches comprises at least two electrode sets.

69. A biosensor, comprising:

a biosensor body having a base substrate with an electrical pattern formed thereon;

the biosensor body defining a measurement zone which receives and analyzes a fluid sample;

a first electrode set formed on the base substrate and connected to the electrical pattern; and

an OLED coated on the first electrode set and operable to emit light upon application of a voltage across the first electrode set.

70. The biosensor of claim 69, wherein the OLED emits visible light when the voltage is less than about 10 volts.

71. The biosensor of claim 69, wherein the OLED emits visible light when the voltage is less than about 5 volts.

72. The biosensor of claim 69, wherein the OLED emits visible light when the voltage is less than about 3 volts.

73. The biosensor of claim 69, wherein the first electrode set comprises a micro-electrode set having substantially parallel interdigitated fingers.

74. The biosensor of claim 73, wherein each finger is spaced from the nearest adjacent finger by no more than about 25 μ

m.

75. The biosensor of claim 73, wherein each finger is spaced from the nearest adjacent finger by no more than about 5 μ

m.

76. The biosensor of claim 69, wherein the measurement zone comprises a sample receiving chamber in which is disposed a second set of electrodes for estimating the concentration of an analyte in the fluid sample.

77. The biosensor of claim 76, further comprising a third set of electrodes disposed in the sample receiving chamber.

78. The biosensor of claim 69, wherein the first electrode set is disposed proximate to and illuminates the measurement zone.

79. A biosensor for analyzing a fluid sample, comprising:

a biosensor body;

the biosensor body defining a measurement zone having a sample receiving chamber in which is disposed a measurement electrode for detecting the presence or concentration of an analyte in the fluid sample, the sample receiving chamber including a reagent which reacts with the fluid sample; and

the biosensor body further defining a user interface zone in which is disposed a numerical display which corresponds to concentration of an analyte in the fluid sample.

80. The biosensor of claim 79, wherein the numerical display further comprises a plurality of micro-electrode arrays coated with an OLED.

81. The biosensor of claim 79, wherein the biosensor body is substantially flat.

82. The biosensor of claim 81, wherein the biosensor body comprises at least two substantially flat layers laminated together.

83. The biosensor of claim 82, wherein the at least two substantially flat layers cooperate to form the sample receiving chamber.

84. The biosensor of claim 83, wherein the sample receiving chamber is sized to draw in the fluid sample by capillary action.

85. The biosensor of claim 79, wherein the biosensor body further comprises a meter insertion end having contacts thereon which are adapted to electrically connect to a meter.

86. A biosensor for analyzing a fluid sample, comprising:

a biosensor body having a thickness of less than about 5 mm;

the biosensor body defining a measurement zone for receiving the fluid sample and for estimating the concentration of an analyte in the fluid sample; and

the biosensor body further comprising a display which produces a numerical value that corresponds to the concentration of the analyte in the fluid sample.

87. The biosensor of claim 86, wherein the biosensor body is substantially flat and has a length of less than about 50 mm, a width is less than about 15 mm, and the thickness is less than about 1 mm.

88. The biosensor of claim 86, wherein the measurement zone includes a sample receiving chamber in which is disposed a measurement electrode and a reagent, wherein the biosensor is an electrochemical biosensor.

89. The biosensor of claim 88, wherein the biosensor body comprises at least two substantially flat layers laminated together.

90. The biosensor of claim 89, wherein the at least two substantially flat layers cooperate to form the sample receiving chamber.

91. The biosensor of claim 90, wherein the sample receiving chamber is sized to draw in the fluid sample by capillary action.

92. The biosensor of claim 91, wherein the biosensor body further comprises a meter insertion end having contacts thereon which are adapted to electrically connect to a meter.