Analyte monitoring device and methods of use
DC CAFCFirst Claim
1. A sensor control unit comprising:
- a housing adapted for placement on skin and adapted to receive a portion of an electrochemical sensor extending out of the skin having a plurality of contact pads;
a plurality of conductive contacts disposed on the housing and configured for coupling to the plurality of contact pads on the electrochemical sensor; and
an rf transmitter disposed in the housing and coupled to the plurality of conductive contacts for transmitting data obtained using the electrochemical sensor.
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Abstract
An analyte monitor includes a sensor, a sensor control unit, and a display unit. The sensor has, for example, a substrate, a recessed channel formed in the substrate, and conductive material disposed in the recessed channel to form a working electrode. The sensor control unit typically has a housing adapted for placement on skin and is adapted to receive a portion of an electrochemical sensor. The sensor control unit also includes two or more conductive contacts disposed on the housing and configured for coupling to two or more contact pads on the sensor. A transmitter is disposed in the housing and coupled to the plurality of conductive contacts for transmitting data obtained using the sensor. The display unit has a receiver for receiving data transmitted by the transmitter of the sensor control unit and a display coupled to the receiver for displaying an indication of a level of an analyte. The analyte monitor may also be part of a drug delivery system to alter the level of the analyte based on the data obtained using the sensor.
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Citations
94 Claims
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1. A sensor control unit comprising:
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a housing adapted for placement on skin and adapted to receive a portion of an electrochemical sensor extending out of the skin having a plurality of contact pads;
a plurality of conductive contacts disposed on the housing and configured for coupling to the plurality of contact pads on the electrochemical sensor; and
an rf transmitter disposed in the housing and coupled to the plurality of conductive contacts for transmitting data obtained using the electrochemical sensor. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54, 55, 56, 57, 58, 59, 60, 61, 62, 63, 64, 65, 66, 67, 68, 69, 70, 71, 72, 73, 74, 75, 76, 77, 78, 79, 80, 81, 82, 83, 84, 85, 86, 87, 90, 91, 92, 93, 94)
a sensor comprising at least one working electrode and at least one contact pad coupled to the at least one working electrode; and
the sensor control unit of claim 1.
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35. The sensor assembly of claim 34, wherein the plurality of conductive contacts, the plurality of contact pads, or both comprise conductive carbon.
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36. The sensor assembly of claim 35, wherein a signal generated by corrosion of the plurality of conductive contacts and the plurality of contact pads when immersed in a 1 mM NaCl solution is 3% or less of a signal generated by the working electrode when exposed to an analyte having a concentration within an expected physiological range.
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37. The sensor assembly of claim 35, wherein a signal generated by corrosion of the plurality of conductive contacts and the plurality of contact pads when immersed in a 100 mM NaCl solution is 3% or less of a signal generated by the working electrode when exposed to an analyte having a concentration within an expected physiological range.
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38. The sensor assembly of claim 34, further comprising a mounting unit adapted for coupling with the housing.
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39. An analyte monitoring system comprising:
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a sensor comprising at least one working electrode and at least one contact pad coupled to the at least one working electrode, the sensor being adapted for implantation of a portion of the sensor comprising the working electrode through skin;
the sensor control unit of claim 1; and
a display unit comprising an rf receiver for receiving data from the sensor control unit, and a display coupled to the rf receiver for displaying an indication of the level of an analyte.
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40. The analyte monitoring system of claim 39, further comprising a mounting unit adapted for coupling with the housing.
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41. The analyte monitoring system of claim 39, wherein the sensor control unit further comprises an rf receiver disposed in the housing and the display unit further comprises an rf transmitter for transmitting to the rf receiver of the sensor control unit.
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42. The analyte monitoring system of claim 39, wherein the display unit further comprises an analyzer coupled to the display and the rf receiver for analyzing data from the rf receiver and providing analyzed data to the display.
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43. The analyte monitoring system of claim 39, wherein the display unit further comprises a battery coupled to the receiver and display.
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44. The analyte monitoring system of claim 39, wherein the display unit further comprises an input device coupled to the display.
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45. The analyte monitoring system of claim 39, further comprising a calibrator for providing a calibration value to at least one of the display unit and the sensor control unit.
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46. The analyte monitoring system of claim 45, wherein the calibrator is coupled to the receiver of the display unit for providing the calibration value to the sensor control unit.
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47. The analyte monitoring system of claim 45, wherein the calibrator provides a calibration value using 1 microliter or less of body fluid.
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48. The analyte monitoring system of claim 45, wherein the calibrator comprises a device configured for non-invasive optical assay of analyte.
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49. The analyte monitoring system of claim 39, wherein the display unit is portable.
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50. The analyte monitoring system of claim 49, wherein the display unit is configured for wearing on a piece of clothing.
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51. The analyte monitoring system of claim 49, further comprising a secondary display unit having a power cord for connecting to an electrical outlet, a receiver for receiving data transmitted by the transmitter, and a display coupled to the receiver for displaying the level of the analyte.
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52. The analyte monitoring system of claim 51, wherein the display unit and the secondary display unit are configured for exchanging data.
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53. The analyte monitoring system of claim 39, wherein the display unit is configured for connection to an electrical outlet.
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54. The analyte monitoring system of claim 53, wherein the display unit further comprises at least one of a lamp, a radio, a clock, an interface to a telephone system, an interface to a computer, or a battery backup system.
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55. The analyte monitoring system of claim 39, wherein the display unit further comprises an alarm configured for activation if a signal from the transmitter of the sensor control unit is not received with a predetermined time interval.
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56. The analyte monitoring system of claim 39, wherein the display unit comprises a pager receiver for receiving pages from an external paging system.
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57. The analyte monitoring system of claim 56, wherein the display unit comprises a pager transmitter for sending pages to the external paging system, wherein the pager transmitter is activated when at least one of hypoglycemia, impending hypoglycemia, hyperglycemia, or impending hyperglycemia is indicated.
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58. The analyte monitoring system of claim 39, wherein the display unit is configured for coupling to an external download device to transfer data from the display unit.
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59. The analyte monitoring system of claim 39, further comprising at least one alarm disposed in the display unit and configured to indicate when a level of an analyte exceeds a threshold level.
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60. The analyte monitoring system of claim 59, wherein the alarm is configured to indicate when a level of an analyte is near a threshold level.
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61. The analyte monitoring system of claim 60, wherein the alarm is configured to indicate at least one of hypoglycemia, impending hypoglycemia, hyperglycemia, or impending hyperglycemia.
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62. The analyte monitoring system of claim 61, wherein the alarm is configured to indicate impending hypoglycemia and is deactivated if an impending hypoglycemia condition does not exist.
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63. The analyte monitoring system of claim 61, wherein the alarm is configured to indicate hypoglycemia and is only manually deactivatable.
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64. The analyte monitoring system of claim 61, wherein the alarm is configured to indicate hypoglycemia and the alarm, when activated, produces an audible signal that increases in loudness over time.
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65. The analyte monitoring system of claim 59, wherein the analyte monitoring system comprises at least two alarms, each alarm producing an audible signal, wherein the signals of the at least two alarms are distinguishable.
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66. The analyte monitoring system of claim 39, further comprising a processing circuit in the display unit, the processing circuit being configured to analyze patient-specific data from multiple episodes to predict a patient'"'"'s response to future episodes.
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67. The analyte monitoring system of claim 66, wherein the patient-specific data comprises a response to a treatment.
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68. The analyte monitoring system of claim 67, wherein the analyte is glucose and the treatment is an administration of insulin.
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69. The analyte monitoring system of claim 67, wherein the display unit further comprises an input device for indicating when a treatment is administered.
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70. The analyte monitoring system of claim 66, wherein the processing circuit is configured to determine a drug administration protocol in response to the patient-specific data.
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71. The analyte monitoring system of claim 66, wherein the patient-specific data is a dosage dependence of a response to a drug.
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72. The analyte monitoring system of claim 66, wherein the display unit further comprises an input device for indicating when food has been injested.
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73. The analyte monitoring system of claim 72, where the input device is configured for indicating an approximate caloric content of the food.
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74. The analyte monitoring system of claim 39, further comprising a temperature measurement device to correct data obtained from the sensor.
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75. The analyte monitoring system of claim 74, wherein the temperature measurement device comprises a temperature probe disposed on the substrate.
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76. The analyte monitoring system of claim 39, wherein the analyte monitoring system further comprises a drug administration system which dispenses a drug based on the level of the analyte.
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77. The analyte monitoring system of claim 76, wherein the drug administration system comprises a receiver for receiving data from at least one of the sensor control unit or display unit to direct dispensing of the drug.
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78. The analyte monitoring system of claim 76, wherein the drug administration system comprises at least one of a needle, syringe, pump, catheter, inhaler, or transdermal patch to administer the drug.
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79. The analyte monitoring system of claim 76, wherein the drug is insulin.
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80. A method for monitoring a level of an analyte using the analyte monitoring system of claim 39, the method comprising:
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inserting the sensor into skin of a patient;
attaching the sensor control unit to the skin of the patient;
coupling a plurality of conductive contacts disposed in the sensor control unit to a plurality of contact pads disposed on the sensor;
collecting data, using the sensor control unit, regarding a level of an analyte from signals generated by the sensor;
transmitting the collected data to the display unit using the rf transmitter of the sensor control unit; and
displaying an indication of the level of the analyte on the display of the display unit.
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81. The method of claim 80, wherein collecting data comprises generating signals from the sensor and processing the signals into data.
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82. The method of claim 80, wherein the data comprises the signals from the sensor.
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83. The method of claim 80, further comprising activating an alarm if the data indicates an alarm condition.
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84. The method of claim 80, further comprising administering a drug in response to the data.
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85. The method of claim 80, further comprising obtaining a calibration value from a calibration device to calibrate the data.
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86. The method of claim 85, wherein the calibration device is coupled to the display unit.
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87. The method of claim 86, further comprising transmitting the calibration value from a transmitter in the display unit to a receiver in the sensor control unit.
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90. A method for monitoring a level of an analyte using the analyte monitoring system of claim 39, the method comprising:
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inserting the sensor into skin of a patient;
attaching the sensor control unit to the skin of the patient;
coupling a plurality of conductive contacts disposed in the sensor control unit to a plurality of contact pads disposed on the sensor;
collecting data, using the sensor control unit, regarding a level of an analyte from signals generated by the sensor;
transmitting the collected data to the display unit using the rf transmitter of the sensor control unit;
displaying an indication of the level of the analyte on the display of the display unit; and
replacing the sensor with a new sensor after a period of use.
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91. The analyte monitoring system of claim 74, wherein the analyte monitoring system if configured and arranged to determine a temperature near the sensor using two electrodes of the sensor.
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92. The analyte monitoring system of claim 39, wherein the sensor further comprises an enzyme non-leachably disposed on the at least one working electrode.
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93. The analyte monitoring system of claim 39, wherein the working electrode comprises a mixture of conductive material and an analyte-responsive enzyme.
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94. The analyte monitoring system of claim 39, wherein the sensor further comprises a mass transport limiting membrane disposed over the working electrode, the mass transport limiting member maintaining a rate of permeation of the analyte through the mass transport limiting membrane with a variation of no more than 3% per °
- C. at temperatures ranging from 30°
C. to 40°
C.
- C. at temperatures ranging from 30°
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32. A sensor assembly, comprising:
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a sensor having a substrate, at least one recessed channel formed in a surface of the substrate, conductive material disposed in the at least one recessed channel to form at least one working electrode and an individual contact pad for each of the at least one working electrodes; and
a sensor control unit for placement on a skin of an animal, the sensor control unit including a housing having a port through which the sensor penetrates the housing, and a plurality of conductive contacts disposed in the housing and configured for coupling with the contact pads of the sensor.
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33. A sensor assembly, comprising:
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a sensor comprising a flexible substrate with at least one working electrode, at least one counter electrode, and at least one contact pad coupled to each of the working and counter electrodes, the sensor being adapted for implantation of a portion of the sensor comprising the working and counter electrodes through skin; and
a sensor control unit comprising a housing adapted for placement on skin;
a plurality of conductive contacts disposed on the housing and configured for coupling to the contact pads of the sensor; and
an rf transmitter disposed in the housing and coupled to the plurality of conductive contacts for transmitting data obtained using the sensor.
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88. An analyte monitoring system comprising:
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(a) a sensor comprising at least one working electrode and at least one contact pad coupled to the at least one working electrode, the sensor being adapted for implantation of a portion of the sensor comprising the working electrode through skin;
(b) a sensor control unit comprising, (i) a housing adapted for placement on skin and adapted to receive a portion of an electrochemical sensor having a plurality of contact pads;
(ii) a plurality of conductive contacts disposed on the housing and configured for coupling to the plurality of contact pads on the electrochemical sensor; and
(iii) an rf transmitter disposed in the housing and coupled to the plurality of conductive contacts for transmitting data obtained using the electrochemical sensor; and
(c) a display unit comprising a receiver for receiving data from the sensor control unit, and a display coupled to the receiver for displaying an indication of the level of an analyte, wherein the transmitter of the sensor control unit and the receiver of the display unit are capable of transmitting and receiving data when separated by a distance of two meters.
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89. A sensor control unit comprising:
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a housing adapted for placement on skin and adapted to receive a portion of an independent electrochemical sensor extending out of the skin and having at least one contact pad;
at least one conductive contact configured for coupling to the at least one contact pad on the independent electrochemical sensor; and
an rf transmitter disposed in the housing and coupled to the at least one conductive contact for transmitting data obtained using the independent electrochemical sensor.
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Specification