Analyte Monitoring Device and Methods of Use

• US 20110011399A1
• Filed: 09/27/2010
• Published: 01/20/2011
• Est. Priority Date: 04/30/1998
• Status: Active Grant

• Current Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Inventors: Wolpert, Howard, Heller, Adam
• Granted Patent: US 8,287,454 B2
• Time in Patent Office: Days
• US Class Current: 128/203.14
• CPC Class Codes: A61B 2560/0252 using ambient temperature
• CPC Class Codes: A61B 2560/063 Devices specially adapted for delivering implantable medical measuring apparatus
• CPC Class Codes: A61B 5/0002 Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network A61B5/07 takes precedence; transmission systems for measured values G08C; transmission H04B; transmission of digital information H04L; wireless communication networks H04W
• CPC Class Codes: A61B 5/1118 Determining activity level
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/14546 for measuring analytes not otherwise provided for, e.g. ions, cytochromes
• CPC Class Codes: A61B 5/1473 invasive, e.g. introduced into the body by a catheter A61B5/1482 takes precedence
• CPC Class Codes: A61B 5/1486 using enzyme electrodes, e.g. with immobilised oxidase
• CPC Class Codes: A61B 5/14865 invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors
• CPC Class Codes: A61B 5/4839 combined with drug delivery
• CPC Class Codes: A61B 5/7275 Determining trends in physiological measurement data; Predicting development of a medical condition based on physiological measurements, e.g. determining a risk factor
• CPC Class Codes: A61B 5/7445 Display arrangements, e.g. multiple display units
• CPC Class Codes: A61M 2205/3569 sublocal, e.g. between console and disposable
• CPC Class Codes: A61M 5/14244 adapted to be carried by the patient, e.g. portable on the body
• 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: H01L 23/3107 the device being completely enclosed
• CPC Class Codes: H01L 23/49548 Cross section geometry H01L23/49562 takes precedence
• CPC Class Codes: H01L 2924/00 Indexing scheme for arrangements or methods for connecting or disconnecting semiconductor or solid-state bodies as covered by H01L24/00
• CPC Class Codes: H01L 2924/0002 Not covered by any one of groups H01L24/00, H01L24/00 and H01L2224/00
• CPC Class Codes: H01L 2924/19041 being a capacitor
• CPC Class Codes: H01L 2924/3011 : Impedance

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.

Claims

1-20. -20. (canceled)

21. A glucose monitoring system comprising:

an in vivo sensor for monitoring a glucose level of a user;

a sensor control unit coupled to the sensor to output one or more signals associated with the monitored glucose level of the user; and

a receiver/display unit in communication with the sensor control unit and comprising;

a receiver to receive the outputted one or more signals from the sensor control unit;

an input device to receive an input from the user, wherein the input comprises a type of medication, a medication sensitivity, a drug delivery information, a food intake, and an exercise level;

a processor to evaluate the one or more signals from the sensor control unit and the input from the user to produce a result comprising the glucose level in interstitial fluid of the user, the glucose level in blood of the user, a rate of change of the glucose level, an acceleration in the rate of change of the glucose level, a dose of a medication, insulin on board information and an insulin sensitivity factor; and

a display in communication with the processor.

22. The system of claim 21, wherein the result further comprises one or more of an insulin action curve, a carbohydrate action curve and a basal profile information.

23. The system of claim 21, wherein the medication comprises insulin.

24. The system of claim 21, wherein the processor temporarily disables one or more therapy related functions executable by the user if one or more of the glucose level, the rate of change of the glucose level and the acceleration in the rate of change of the glucose level meets or exceeds a threshold level.

25. The system of claim 21, wherein the display displays a warning indication to the user if one or more of the glucose level, the rate of change of the glucose level and the acceleration in the rate of change of the glucose level meets or exceeds a threshold level.

26. The system of claim 25, wherein the warning indication comprises one of more of:

an indication of hypoglycemia;

an indication of impending hypoglycemia;

an indication of hyperglycemia;

an indication of impending hyperglycemia;

an indication of a malfunction; and

an indication of an error condition.

27. The system of claim 21, wherein the processor tags the one or more signals with an event marker.

28. The system of claim 27, wherein the event marker comprises one or more of a hypoglycemic episode, a hyperglycemic episode, the food intake, the drug delivery information, and the exercise level.

29. The system of claim 21, wherein the system comprises an integrated unit including the sensor, the sensor control unit and the receiver/display unit.

30. The system of claim 21, wherein the sensor control unit and the receiver/display unit are separate units.

31. The system of claim 30, wherein the sensor control unit comprises a transmitter to transmit the one or more signals from the sensor control unit to the receiver/display unit.

32. The system of claim 21, wherein the receiver/display unit further comprises a data storage unit to store at least one of the one or more signals and the result.

33. The system of claim 21, wherein the receiver/display unit further comprises a port to connect the receiver/display unit to a computer.

34. The system of claim 33, wherein the receiver/display unit transmits at least one of the one or more signals and the result from the receiver/display unit to the computer.

35. The system of claim 21, wherein the display displays the result as text.

36. The system of claim 21, wherein the display displays the result as a graph or a chart.

37. The system of claim 21, wherein the input device comprises a touch screen display.

38. The system of claim 21, wherein the sensor comprises an implantable glucose sensor.

39. The system of claim 21, further comprising a medication administration device.

40. The system of claim 39, wherein the medication administration device comprises at least one of a needle, a syringe, a pump, a catheter, an inhaler, or a transdermal patch.

41. A method of monitoring a glucose level of a user, the method comprising:

monitoring a glucose level of a user with an in vivo sensor for monitoring the glucose level of the user;

outputting from a sensor control unit one or more signals associated with the monitored glucose level of the user;

receiving at a receiver/display unit the outputted one or more signals;

receiving an input from the user through an input device, wherein the input comprises a type of medication, a medication sensitivity, a drug delivery information, a food intake, and an exercise level;

analyzing the one or more signals and the input from the user with a processor of the receiver/display unit to produce a result comprising the glucose level in interstitial fluid of the user, the glucose level in blood of the user, a rate of change of the glucose level, an acceleration in the rate of change of the glucose level, a dose of a medication, insulin on board information and an insulin sensitivity factor; and

displaying the glucose level of the user on a display of the receiver/display unit.

42. The method of claim 41, wherein the result further comprises one or more of an insulin action curve, a carbohydrate action curve and a basal profile information.

43. The method of claim 41, wherein the analyzing comprises one or more of:

modifying the one or more outputted signals from the sensor control unit;

determining the glucose level in interstitial fluid of the user;

determining the glucose level in blood of the user;

determining the rate of change of the glucose level;

determining the acceleration in the rate of change of the glucose level;

comparing one or more of the glucose level, the rate of change of the glucose level and the acceleration in the rate of change of the glucose level to a threshold value;

evaluating trends in the glucose level over time;

determining a dose of a medication;

reducing noise; and

reducing error.

44. The method of claim 43, wherein the analyzing comprises determining the dose of the medication.

45. The method of claim 44, wherein the medication comprises insulin.

46. The method of claim 41, further comprising temporarily disabling one or more therapy related functions executable by the user if one or more of the glucose level, the rate of change of the glucose level and the acceleration in the rate of change of the glucose level meets or exceeds a threshold value.

47. The method of claim 41, further comprising displaying a warning indication to the user if one or more of the glucose level, the rate of change of the glucose level and the acceleration in the rate of change of the glucose level meets or exceeds a threshold value.

48. The method of claim 47, wherein the warning indication comprises one of more of:

an indication of hypoglycemia;

an indication of impending hypoglycemia;

an indication of hyperglycemia;

an indication of impending hyperglycemia;

an indication of a malfunction; and

an indication of an error condition.

49. The method of claim 41, further comprising tagging the one or more signals with an event marker.

50. The method of claim 49, wherein the event marker comprises one or more of a hypoglycemic episode, a hyperglycemic episode, the food intake, the drug delivery information, and the exercise level.

51. The method of claim 41, wherein the outputting comprises wirelessly transmitting the one or more signals from the sensor control unit to the receiver/display unit.

52. The method of claim 41, further comprising storing at least one of the one or more signals and the result in a data storage unit of the receiver/display unit.

53. The method of claim 41, further comprising connecting the receiver/display unit to a computer.

54. The method of claim 53, further comprising transmitting at least one of the one or more signals and the result from the receiver/display unit to the computer.

55. The method of claim 41, wherein the displaying comprises displaying the result as text.

56. The method of claim 41, wherein the displaying comprises displaying the result as a graph or a chart.

57. The method of claim 41, wherein the input device comprises a touch screen display.

58. The method of claim 41, wherein the sensor comprises an implantable glucose sensor.

59. The method of claim 41, further comprising administering a dose of a medication to the user using a medication administration device.

60. The method of claim 59, wherein the medication administration device comprises at least one of a needle, a syringe, a pump, a catheter, an inhaler, or a transdermal patch.

67. The method of claim 46, wherein the warning indication comprises one of more of:

an indication of hypoglycemia;

an indication of impending hypoglycemia;

an indication of hyperglycemia;

an indication of impending hyperglycemia;

an indication of a malfunction; and

an indication of an error condition.

61. A method of managing insulin therapy of a user, the method comprising:

analyzing with a processor of a receiver/display unit;

(a) one or more signals associated with an in vivo monitored glucose level of the user, and (b) an input from the user, wherein the input comprises a drug delivery information, a food intake, and an exercise level, to produce a result comprising a dose of insulin;

displaying the result to the user on a display of the receiver/display unit;

verifying that the user intends to administer the dose of insulin; and

administering the dose of insulin to the user using a medication administration device.

62. The method of claim 61, wherein the input from the user further comprises one or more of a type of medication and a medication sensitivity.

63. The method of claim 61, wherein the result further comprises the signals associated with the glucose level of the user, the glucose level in interstitial fluid of the user, the glucose level in blood of the user, a rate of change of the glucose level, an acceleration in the rate of change of the glucose level, insulin on board information and an insulin sensitivity factor.

64. The method of claim 61, wherein the result further comprises one or more of an insulin action curve, a carbohydrate action curve and a basal profile information.

65. The method of claim 63, further comprising temporarily disabling one or more therapy related functions executable by the user if one or more of the glucose level, the rate of change of the glucose level and the acceleration in the rate of change of the glucose level meets or exceeds a threshold value.

66. The method of claim 63, further comprising displaying a warning indication to the user if one or more of the glucose level, the rate of change of the glucose level and the acceleration in the rate of change of the glucose level meets or exceeds a threshold value.

68. The method of claim 61, further comprising tagging the one or more signals with an event marker.

69. The method of claim 68, wherein the event marker comprises one or more of a hypoglycemic episode, a hyperglycemic episode, the food intake, the drug delivery information, and the exercise level.

70. The method of claim 61, further comprising storing the result in a data storage unit of the receiver/display unit.

71. The method of claim 61, further comprising connecting the receiver/display unit to a computer.

72. The method of claim 71, further comprising transmitting the result from the receiver/display unit to the computer.

73. The method of claim 61, wherein the displaying comprises displaying the result as text.

74. The method of claim 61, wherein the displaying comprises displaying the result as a graph or a chart.

75. The method of claim 61, wherein the medication administration device comprises at least one of a needle, a syringe, a pump, a catheter, an inhaler, or a transdermal patch.