Smart sensor ports and methods of using same

• US 8,758,583 B2
• Filed: 04/28/2009
• Issued: 06/24/2014
• Est. Priority Date: 04/28/2009
• 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., Rush, Benjamin, Haley, Charlene
• Primary Examiner(s): Van, Luan
• Assistant Examiner(s): Kaur, Gurpreet
• Application Number:
  US12/431,672
• Publication Number:
  US 20100274181A1
• Time in Patent Office: 1,883 Days
• Field of Search: 600/347, 422/50, 422/76, 422/82.01, 422/82.02, 73/530.1, 20440301-40315, 205/777.5, 205/778, 205/792
• US Class Current: 204/403.02
• CPC Class Codes: A61M 5/1723 using feedback of body parameters, e.g. blood-sugar, pressure measurement of body parameters A61B5/00
• CPC Class Codes: G01N 27/3273 Devices therefor, e.g. test element readers, circuitry details not specific to biochemical electrodes G01N33/4875
• CPC Class Codes: G01N 27/48 using polarography, i.e. measuring changes in current under a slowly-varying voltage
• CPC Class Codes: G01N 33/48707 by electrical means G01N33/49, G01N33/493 take precedence

Abstract

The present disclosure provides an orientation-nonspecific sensor port for use in analyte meters designed to detect and quantify analyte levels in a fluid sample along with methods of using the same. The present disclosure also provides compositions and methods for facilitating the correct insertion of a sensor into a corresponding analyte meter.

Claims

1. An analyte meter comprising:

a housing;

a sensor port coupled to the housing, wherein the sensor port is configured to receive a sensor to determine the concentration of an analyte in a fluid sample, and wherein the sensor port comprises;

a first electrode contact; and

a second electrode contact,

wherein each of the first electrode contact and the second electrode contact is capable of being configured as a working electrode contact,

wherein the analyte meter is configured to detect first and second different insertion orientations of the sensor upon insertion of the sensor into the sensor port, and based on the first or second insertion orientation, the analyte meter configures one of the first electrode contact and the second electrode contact as a working electrode contact; and

a controller unit coupled to the housing, the controller unit configured to process a signal received from the sensor and determine a concentration of the analyte based on the signal.

2. The analyte meter of claim 1, wherein each of the first electrode contact and the second electrode contact is also capable of being configured as a reference and/or counter electrode contact, and based on the first or second insertion orientation, the analyte meter configures the first electrode contact as a working electrode contact and the second electrode contact as a reference and/or counter electrode contact.

3. The analyte meter of claim 1, further comprising a third electrode contact.

4. The analyte meter of claim 3, wherein the third electrode contact is capable of being configured as an indicator electrode contact.

5. The analyte meter of claim 3, further comprising a fourth electrode contact.

6. The analyte meter of claim 1, wherein the sensor port is configured to receive a sensor comprising two electrodes.

7. The analyte meter of claim 1, wherein the sensor port is configured to receive a sensor comprising three electrodes.

8. The analyte meter of claim 1, wherein the sensor port is configured to receive a sensor comprising four electrodes.

9. The analyte meter of claim 1, wherein the sensor port is configured to receive a sensor comprising opposing working and reference and/or counter electrodes.

10. The analyte meter of claim 1, wherein the sensor port is configured to receive a sensor comprising coplanar working and reference and/or counter electrodes.

11. The analyte meter of claim 1, wherein the analyte is glucose.

12. The analyte meter of claim 1, wherein the analyte is ketone bodies.

13. The analyte meter of claim 1, wherein the analyte meter is activated upon insertion of the sensor into the sensor port.

14. The analyte meter of claim 13, wherein the sensor comprises a turn-on/selection monitor, the sensor port comprises a turn-on/selection contact, and the turn-on/selection monitor contacts the turn-on/selection contact upon insertion of the sensor into the sensor port, thereby activating the analyte meter.

15. The analyte meter of claim 14, wherein contact of the turn-on/selection contact with the turn-on/selection monitor opens or closes an electrical circuit, wherein opening or closing of the electrical circuit indicates the insertion orientation of the sensor.

16. The analyte meter of claim 1, wherein the sensor port comprises a first turn-on/selection contact and a second turn-on/selection contact, wherein the first turn-on/selection contact and the second turn-on/selection contact are positioned in an opposing configuration in the sensor port.

17. The analyte meter of claim 1, wherein the analyte meter detects the insertion orientation of the sensor by physical, mechanical, optical, or electrical means.

18. The analyte meter of claim 1, wherein the analyte meter detects the insertion orientation of the sensor by electrical means.

19. The analyte meter of claim 18, wherein the analyte meter detects the insertion orientation of the sensor by detecting the opening of an electrical circuit upon insertion of the sensor into the sensor port.

20. The analyte meter of claim 18, wherein the analyte meter detects the insertion orientation of the sensor by detecting the closing of an electrical circuit upon insertion of the sensor into the sensor port.

21. The analyte meter of claim 1, wherein the controller unit is configured to perform an algorithm to determine a medication dose based on a determined concentration of analyte.

22. The analyte meter of claim 21, wherein the analyte meter further comprises a medication delivery device for administering a medication dose to a subject, wherein the medication dose is determined by the controller unit using the algorithm.

23. The analyte meter of claim 22, wherein the analyte is glucose and the medication is insulin.

24. The analyte meter of claim 22, wherein the medication delivery device comprises a needle, syringe, pump, catheter, inhaler, transdermal patch or combination thereof to deliver the medication.

25. The analyte meter of claim 1, wherein the controller unit is configured to determine the concentration of the analyte by amperometry, coulometry, potentiometry, and/or voltametry using the signal received from the sensor.

26. The analyte meter of claim 1, wherein the controller unit is further configured to determine a bolus dosage based on the signal received from the sensor.

27. The analyte meter of claim 26, further comprising an input unit coupled to the housing, wherein the controller unit is configured to determine the bolus dosage in response to a command received from the input unit.

28. The analyte meter of claim 27, wherein the input unit comprises one or more of an input button, a touch sensitive screen, a jog wheel, or combinations thereof.

29. The analyte meter of claim 1, wherein the housing comprises a display unit disposed thereon.

30. The analyte meter of claim 29, wherein the controller unit is further configured to determine a bolus dosage based on the signal received from the sensor.

31. The analyte meter of claim 30, wherein the controller unit is further configured to display the determined bolus dosage on the display unit.

32. The analyte meter of claim 31, wherein the displayed bolus dosage is one or more of an alphanumeric display, a graphical display, a video display, an audio display, a vibratory output, or combinations thereof.

33. The analyte meter of claim 11, wherein the analyte meter comprises a receiver and/or transmitter for communicating with a continuous glucose monitor.

34. The analyte meter of claim 11, wherein the analyte meter comprises a receiver and/or transmitter for communicating with a medication delivery device.

35. A method for determining a concentration of an analyte in a fluid sample, the method comprising:

contacting a fluid sample with a sensor inserted into an analyte meter, wherein the analyte meter comprises;

a housing;

a sensor port coupled to the housing, wherein the sensor port is configured to receive a sensor for determining the concentration of an analyte in a fluid sample, and wherein the sensor port comprises;

a first electrode contact; and

a second electrode contact,

wherein each of the first electrode contact and the second electrode contact is capable of being configured as a working electrode contact,

wherein the analyte meter is configured to detect first and second different insertion orientations of the sensor upon insertion of the sensor into the sensor port, and based on the first or second insertion orientation, the analyte meter configures one of the first electrode contact and the second electrode contact as a working electrode contact; and

a controller unit coupled to the housing, the controller unit configured to process a signal received from the sensor and determine a concentration of the analyte based on the signal;

generating a sensor signal using the sensor; and

determining the concentration of the analyte using the generated sensor signal.

36. The method of claim 35, wherein each of the first electrode contact and the second electrode contact is also capable of being configured as a reference and/or counter electrode contact, and based on the first or second insertion orientation, the analyte meter configures the first electrode contact as a working electrode contact and the second electrode contact as a reference and/or counter electrode contact.

37. The method of claim 35, further comprising a third electrode contact.

38. The method of claim 37, wherein the third electrode contact is capable of being configured as an indicator electrode contact.

39. The method of claim 37, further comprising a fourth electrode contact.

40. The method of claim 35, wherein the sensor port is configured to receive a sensor comprising two electrodes.

41. The method of claim 35, wherein the sensor port is configured to receive a sensor comprising three electrodes.

42. The method of claim 35, wherein the sensor port is configured to receive a sensor comprising four electrodes.

43. The method of claim 35, wherein the sensor port is configured to receive a sensor comprising opposing working and reference and/or counter electrodes.

44. The method of claim 35, wherein the sensor port is configured to receive a sensor comprising coplanar working and reference and/or counter electrodes.

45. The method of claim 35, wherein the analyte is glucose or ketone bodies.

46. The method of claim 35, wherein the analyte meter is activated upon insertion of the sensor into the sensor port.

47. The method of claim 46, wherein the sensor comprises a turn-on/selection monitor, the sensor port comprises a turn-on/selection contact, and the turn-on/selection monitor contacts the turn-on/selection contact upon insertion of the sensor into the sensor port, thereby activating the analyte meter.

48. The method of claim 47, wherein contact of the turn-on/selection contact with the turn-on/selection monitor opens or closes an electrical circuit, wherein opening or closing of the electrical circuit indicates the insertion orientation of the sensor.

49. The method of claim 35, wherein the sensor port comprises a first turn-on/selection contact and a second turn-on/selection contact, wherein the first turn-on/selection contact and the second turn-on/selection contact are positioned in an opposing configuration in the sensor port.

50. The method of claim 35, wherein the analyte meter detects the insertion orientation of the sensor by physical, mechanical, optical, or electrical means.

51. The method of claim 35, wherein the analyte meter detects the insertion orientation of the sensor by electrical means.

52. The method of claim 51, wherein the analyte meter detects the insertion orientation of the sensor by detecting the opening of an electrical circuit upon insertion of the sensor into the sensor port.

53. The method of claim 51, wherein the analyte meter detects the insertion orientation of the sensor by detecting the closing of an electrical circuit upon insertion of the sensor into the sensor port.

54. The method of claim 35, wherein the controller unit is configured to perform an algorithm to determine a medication dose based on a determined concentration of analyte, and wherein the method further comprises determining the medication dose based on the determined concentration of analyte.

55. The method of claim 54, wherein the analyte meter further comprises a medication delivery device for administering a medication dose to a subject, wherein the medication dose is determined by the controller unit using the algorithm, and wherein the method further comprises administering the medication dose to the subject using the medication delivery device.

56. The method of claim 55, wherein the analyte is glucose and the medication is insulin.

57. The method of claim 55, wherein the medication delivery device comprises a needle, syringe, pump, catheter, inhaler, transdermal patch or combination thereof to deliver the medication.

58. The method of claim 35, wherein the controller unit is configured to determine the concentration of the analyte by amperometry, coulometry, potentiometry, and/or voltametry using the signal received from the sensor, and wherein the method further comprises determining the concentration of the analyte by amperometry, coulometry, potentiometry, and/or voltametry using the signal received from the sensor.

59. The method of claim 35, wherein the controller unit is configured to determine a bolus dosage based on the signal received from the sensor, and wherein the method further comprises determining a bolus dosage based on the signal received from the sensor.

60. The method of claim 59, wherein the analyte meter comprises an input unit coupled to the housing, wherein the controller unit is configured to determine the bolus dosage in response to a command received from the input unit, and wherein the method further comprises inputting the command using the input unit and determining the bolus dosage.

61. The method of claim 60, wherein the input unit comprises one or more of an input button, a touch sensitive screen, a jog wheel, or combinations thereof.

62. The method of claim 35, wherein the housing comprises a display unit disposed thereon.

63. The method of claim 62, wherein the controller unit is configured to determine a bolus dosage based on the signal received from the sensor, and wherein the method further comprises determining the bolus dosage based on the signal received from the sensor.

64. The method of claim 63, wherein the controller unit is configured to display the determined bolus dosage on the display unit, and wherein the method further comprises displaying the determined bolus dosage on the display unit.

65. The method of claim 64, wherein the displayed bolus dosage is one or more of an alphanumeric display, a graphical display, a video display, an audio display, a vibratory output, or combinations thereof.

66. The method of claim 35, wherein the analyte meter comprises a receiver and/or transmitter for communicating with a continuous glucose monitor, and wherein the method further comprises communicating with the continuous glucose monitor using the receiver and/or transmitter.

67. The method of claim 35, wherein the analyte meter comprises a receiver and/or transmitter for communicating with a medication delivery device, and wherein the method further comprises communicating with the medication delivery device using the receiver and/or transmitter.

68. A system comprising:

an analyte meter, wherein the analyte meter comprises;

a housing;

a sensor port coupled to the housing, wherein the sensor port is configured to receive a sensor for determining the concentration of an analyte in a fluid sample, and wherein the sensor port comprises;

a first electrode contact; and

a second electrode contact,

wherein each of the first electrode contact and the second electrode contact is capable of being configured as a working electrode contact,

wherein the analyte meter is configured to detect first and second different insertion orientations of the sensor upon insertion of the sensor into the sensor port, and based on the first or second insertion orientation, the analyte meter configures one of the first electrode contact and the second electrode contact as a working electrode contact; and

a controller unit coupled to the housing, the controller unit configured to process a signal received from the sensor and determine a concentration of the analyte based on the signal;

a lancet; and

a sensor.

69. The system of claim 68, wherein the sensor is a test strip.

70. The system of claim 69, wherein the lancet and the test strip are integrated into the housing of the analyte meter.

71. The system of claim 70, wherein a cartridge or magazine comprising test strips is integrated into the housing of the analyte meter.

72. The system of claim 68, wherein each of the first electrode contact and the second electrode contact is also capable of being configured as a reference and/or counter electrode contact, and based on the first or second insertion orientation, the analyte meter configures the first electrode contact as a working electrode contact and the second electrode contact as a reference and/or counter electrode contact.

73. The system of claim 68, wherein the analyte meter further comprises a third electrode contact.

74. The system of claim 73, wherein the third electrode contact is capable of being configured as an indicator electrode contact.

75. The system of claim 73, wherein the analyte meter further comprises a fourth electrode contact.

76. The system of claim 68, wherein the sensor port is configured to receive a sensor comprising two electrodes.

77. The system of claim 68, wherein the sensor port is configured to receive a sensor comprising three electrodes.

78. The system of claim 68, wherein the sensor port is configured to receive a sensor comprising four electrodes.

79. The system of claim 68, wherein the sensor port is configured to receive a sensor comprising opposing working and reference and/or counter electrodes.

80. The system of claim 68, wherein the sensor port is configured to receive a sensor comprising coplanar working and reference and/or counter electrodes.

81. The system of claim 68, wherein the analyte is glucose or ketone bodies.

82. The system of claim 68, wherein the analyte meter is activated upon insertion of the sensor into the sensor port.

83. The system of claim 82, wherein the sensor comprises a turn-on/selection monitor, the sensor port comprises a turn-on/selection contact, and the turn-on/selection monitor contacts the turn-on/selection contact upon insertion of the sensor into the sensor port, thereby activating the analyte meter.

84. The system of claim 83, wherein contact of the turn-on/selection contact with the turn-on/selection monitor opens or closes an electrical circuit, wherein opening or closing of the electrical circuit indicates the insertion orientation of the sensor.

85. The system of claim 68, wherein the sensor port comprises a first turn-on/selection contact and a second turn-on/selection contact, wherein the first turn-on/selection contact and the second turn-on/selection contact are positioned in an opposing configuration in the sensor port.

86. The system of claim 68, wherein the analyte meter detects the insertion orientation of the sensor by physical, mechanical, optical, or electrical means.

87. The system of claim 68, wherein the analyte meter detects the insertion orientation of the sensor by electrical means.

88. The system of claim 87, wherein the analyte meter detects the insertion orientation of the sensor by detecting the opening of an electrical circuit upon insertion of the sensor into the sensor port.

89. The system of claim 87, wherein the analyte meter detects the insertion orientation of the sensor by detecting the closing of an electrical circuit upon insertion of the sensor into the sensor port.

90. An integrated analyte measuring device comprising:

an analyte meter, wherein the analyte meter comprises;

a housing;

a sensor port coupled to the housing, wherein the sensor port is configured to receive a sensor for determining the concentration of an analyte in a fluid sample, and wherein the sensor port comprises;

a first electrode contact; and

a second electrode contact,

wherein each of the first electrode contact and the second electrode contact is capable of being configured as a working electrode contact,

wherein the analyte meter is configured to detect first and second different insertion orientations of the sensor upon insertion of the sensor into the sensor port, and based on the first or second insertion orientation, the analyte meter configures one of the first electrode contact and the second electrode contact as a working electrode contact; and

a controller unit coupled to the housing, the controller unit configured to process a signal received from the sensor and determine a concentration of the analyte based on the signal;

a plurality of lancets incorporated into the housing; and

a plurality of sensors incorporated into the housing.