Biosensor with multiple electrical functionalities

• US 7,867,369 B2
• Filed: 06/18/2004
• Issued: 01/11/2011
• Est. Priority Date: 06/20/2003
• Status: Expired due to Fees

• 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
• Primary Examiner(s): Olsen; Kaj K
• Application Number:
  US10/871,843
• Publication Number:
  US 20050023137A1
• Time in Patent Office: 2,398 Days
• Field of Search: 204/403, 204/406, 204/418, 204/403.01, 204/403.02, 204/403.03, 204/403.13, 435/817, 435/288, 435/291
• US Class Current: 204/403.02
• 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 test strip;

the test strip 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, the test strip including a dosing edge wherein the sample receiving chamber is open at the dosing edge to receive the fluid sample;

the test strip 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, further 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; and

the test strip including a meter insertion end having contacts thereon that are adapted to electrically connect to a test meter.

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

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

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

5. The biosensor of claim 4, further comprising a micro-electrode set disposed on a substantially planar surface of the test strip, the OLED being coated onto the micro-electrode set.

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

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

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

9. The biosensor of claim 8, wherein the digital device comprises an electrical pattern encoded with at least one parameter about the biosensor.

10. The biosensor of claim 8, wherein the digital device comprises an integrated circuit.

11. The biosensor of claim 8, wherein the digital device comprises an RFID tag.

12. The biosensor of claim 8, wherein the digital device is encoded with the type of analyte the biosensor is configured to analyze.

13. The biosensor of claim 8, wherein the digital device is encoded with at least one of a lot code and an expiration date of the biosensor.

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

15. The biosensor of claim 14, wherein the power generator is electrically connected to the signal generator and provides power thereto upon the occurrence of the triggering event.

16. The biosensor of claim 14, wherein the power generator comprises a battery.

17. The biosensor of claim 16, wherein the battery comprises a thin film.

18. The biosensor of claim 14, wherein the power generator comprises a capacitor that discharges upon the occurrence of the triggering event.

19. The biosensor of claim 14, wherein the power generator generates at least 2 volts for at least 2 seconds upon the occurrence of the triggering event.

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

21. 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.

22. The biosensor of claim 21, wherein the second set of electrodes comprises a pair of electrodes with substantially parallel, interdigitated fingers, each electrode having at least two fingers.

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

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

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

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

a test strip;

a measurement zone disposed in or on the test strip, the measurement zone defining a sample receiving chamber in which the fluid sample is received and analyzed;

a power generator disposed in or on the test strip;

a user interface zone disposed in or on the test strip, the user interface zone having an electrically driven signal generator which emits a signal upon occurrence of a triggering event, the signal generator includes a light disposed proximate the sample receiving chamber, the light illuminating the sample receiving chamber upon the occurrence of the triggering event;

the test strip having a meter insertion end that is adapted to electrically connect to a test meter; and

the test strip having a dosing edge wherein the sample receiving chamber is open at the dosing edge to receive the fluid sample.

27. The biosensor of claim 26, wherein the power generator comprises a battery.

28. The biosensor of claim 27, wherein the test strip defines a substantially planar substrate and the battery comprises a thin film adhered to the substrate.

29. The biosensor of claim 26, wherein the power generator comprises a capacitor.

30. The biosensor of claim 26, wherein a sample sufficiency electrode is disposed in the sample receiving chamber, the sample sufficiency electrode is electrically connected to the power generator.

31. The biosensor of claim 26, wherein the electrically driven signal generator emits a visible, audible or tactile signal upon occurrence of the triggering event.

32. The biosensor of claim 31, wherein the test strip further defines a digital information zone in which is disposed a digital device.

33. The biosensor of claim 32, wherein the digital device comprises an electrical pattern encoded with information about the biosensor.

34. The biosensor of claim 26, wherein the test strip 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 26, wherein a reagent is disposed in the sample receiving chamber, the reagent at least partially covering an electrode set for estimating the concentration of an analyte contained in the fluid sample.

37. The biosensor of claim 36, further comprising a second electrode set at least partially disposed within the sample receiving chamber.

38. The biosensor of claim 36, wherein the sample receiving chamber includes a sample sufficiency electrode.

39. The biosensor of claim 26, wherein the test strip defines a substantially planar substrate on which is formed an electrical pattern extending into the measurement zone and power generation zone.

40. The biosensor of claim 39, 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 the sample receiving chamber disposed in the measurement zone.

41. The biosensor of claim 40, 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.

42. The biosensor of claim 41, further comprising a second electrode set disposed within the sample receiving chamber.

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

a test strip;

the test strip having a spacer layer, the spacer layer defining a first opening, a second opening, and a third opening;

the first opening defining a sample receiving chamber having a fluid receiving opening for receiving the fluid sample;

at least five electrical devices positioned on or in the test strip, each electrical device having a specific functionality, the electrical devices comprising first and second sets of electrodes, a power generator, a digital device, and an electrically driven signal generator;

wherein the first and second sets of electrodes are 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;

wherein the second opening is sized to receive the digital device, and the third opening is sized to receive the power generator; and

a user interface zone disposed on the test strip, the user interface zone having the electrically driven signal generator which emits a signal upon occurrence of a triggering event, the electrically driven signal generator includes a light disposed proximate the sample receiving chamber, the light illuminating the sample receiving chamber upon the occurrence of the triggering event.

44. The biosensor of claim 43, further comprising third and fourth sets of electrodes, wherein all four electrode sets are disposed at least partially within the sample receiving chamber.

45. The biosensor of claim 44, wherein each of the four electrode sets comprises the same functionality.

46. The biosensor of claim 44, wherein the sample receiving chamber has a volume of less than about 130 nl.

47. The biosensor of claim 44, wherein the four electrode sets comprises at least two different functionalities.

48. The biosensor of claim 44, wherein the four electrode sets comprises at least three different electrode functionalities.

49. The biosensor of claim 44, wherein the four electrode sets comprises four different electrode functionalities.

50. The biosensor of claim 44, wherein all four electrode sets are the same.

51. The biosensor of claim 44, 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.

52. The biosensor of claim 43, wherein one of the electrical sets comprises a sample sufficiency electrode set in electrical communication with the sample receiving chamber.

53. The biosensor of claim 43, further comprising 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.

54. The biosensor of claim 43, wherein the electrically driven signal generator emits a visible, audible or tactile signal upon occurrence of the triggering event.

55. The biosensor of claim 43, wherein the signal generator comprises an OLED coated on an electrode set.

56. The biosensor of claim 55, wherein the electrode set comprises a micro-electrode array.

57. The biosensor of claim 56, wherein the micro-electrode set comprises substantially parallel, interdigitated fingers, each electrode of the micro-electrode set having at least two fingers.

58. The biosensor of claim 43, wherein the digital device comprises an electrode pattern encoded with digital information about the biosensor.

59. The biosensor of claim 58, wherein the digital information comprises lot code, expiration date or type of analyte.

60. The biosensor of claim 43, wherein the power generator comprises a battery.

61. The biosensor of claim 43, 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.

62. The biosensor of claim 61, wherein at least one of the first and second branches comprises at least two electrode sets.

63. A biosensor, comprising:

a test strip having a base substrate with an electrical pattern formed thereon, the test strip including a spacer layer and a transparent or translucent covering layer overlying the spacer layer, the spacer layer having a void that defines a sample receiving chamber disposed in 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 visible light upon application of a voltage across the first electrode set upon occurrence of a sufficient amount of said fluid sample being collected in said measurement zone, the spacer layer overlying the first electrode set, wherein the first electrode set is disposed proximate to and illuminates the measurement zone.

64. The biosensor of claim 63, wherein the OLED emits visible light when the voltage is less than about 10 volts.

65. The biosensor of claim 63, wherein the OLED emits visible light when the voltage is less than about 5 volts.

66. The biosensor of claim 63, wherein the OLED emits visible light when the voltage is less than about 3 volts.

67. The biosensor of claim 63, wherein the first electrode set comprises a micro-electrode set having substantially parallel interdigitated fingers.

68. The biosensor of claim 67, wherein each finger is spaced from the nearest adjacent finger by no more than about 25 μ

m.

69. The biosensor of claim 67, wherein each finger is spaced from the nearest adjacent finger by no more than about 5 μ

m.

70. The biosensor of claim 63, 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.

71. The biosensor of claim 70, further comprising a third set of electrodes disposed in the sample receiving chamber.

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

a test strip;

the test strip 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, the test strip including a dosing edge wherein the sample receiving chamber is open at the dosing edge to receive the fluid sample;

the test strip further defining a user interface zone in which is disposed a numerical display which corresponds to concentration of an analyte in the fluid sample, wherein the user interface zone includes an electrically driven signal generator which emits a signal upon occurrence of a triggering event, the electrically driven signal generator includes a light disposed proximate the sample receiving chamber, the light illuminating the sample receiving chamber upon the occurrence of the triggering event; and

the test strip including a meter insertion end having contacts thereon which are adapted to electrically connect to a meter.

73. The biosensor of claim 72, wherein the numerical display further comprises a plurality of micro-electrode arrays coated with an OLED.

74. The biosensor of claim 72, wherein the test strip is substantially flat.

75. The biosensor of claim 74, wherein the test strip comprises at least two substantially flat layers laminated together.

76. The biosensor of claim 75, wherein the at least two substantially flat layers cooperate to form the sample receiving chamber.

77. The biosensor of claim 76, wherein the sample receiving chamber is sized to draw in the fluid sample by capillary action.

78. The biosensor of claim 72, wherein the test strip 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.

79. The biosensor of claim 72, wherein the test strip has a thickness of less than about 5 mm.