Analyte monitoring device and methods of use

• US 6,565,509 B1
• Filed: 09/21/2000
• Issued: 05/20/2003
• Est. Priority Date: 04/30/1998
• Status: Expired due to Term

• Current Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories)
• Original Assignee: Therasense Incorporated (Abbott Laboratories)
• Inventors: Say, James, Colman, Fredric C., Aria, Behrad, Tomasco, Michael F., Heller, Ephraim, Heller, Adam, Gal, Yoram, Plante, Phillip John, Vreeke, Mark S., Friedman, Keith A.
• Primary Examiner(s): Hindenburg, Max F.
• Assistant Examiner(s): Natnithithadha, Navin
• Application Number:
  US09/667,199
• Time in Patent Office: 971 Days
• Field of Search: 600/365, 600/345, 600/346, 600/347, 600/354, 600/357, 600/366, 600/309
• US Class Current: 600/365
• CPC Class Codes: A61B 2560/0252 using ambient temperature
• 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 5/002 Monitoring the patient using a local or closed circuit, e.g. in a room or building A61B5/0017 takes precedence
• CPC Class Codes: A61B 5/01 Measuring temperature of body parts ; Diagnostic temperature sensing, e.g. for malignant or inflamed tissue clinical contact thermometers G01K13/20
• CPC Class Codes: A61B 5/14503 invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors A61B5/1459, A61B5/1464, A61B5/1473, A61B5/1482, A61B5/14865 take precedence
• CPC Class Codes: A61B 5/1451 for interstitial fluid
• 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 5/1495 Calibrating or testing of in-vivo probes
• CPC Class Codes: A61B 5/4839 combined with drug delivery
• CPC Class Codes: A61B 5/72 Signal processing specially adapted for physiological signals or for diagnostic purposes character recognition, recognising digital ink, document-oriented image-based pattern recognition G06V30/00; recognition or understanding of postal images G06V30/424
• CPC Class Codes: A61B 5/7278 Artificial waveform generation or derivation, e.g. synthesising signals from measured signals A61B5/327 takes precedence
• CPC Class Codes: A61B 5/7282 Event detection, e.g. detecting unique waveforms indicative of a medical condition A61B5/4094, A61B5/4818, A61B5/349, A61B5/0823 take precedence
• CPC Class Codes: A61B 5/7405 using sound
• CPC Class Codes: A61B 5/743 Displaying an image simultaneously with additional graphical information, e.g. symbols, charts, function plots
• CPC Class Codes: A61B 5/7445 Display arrangements, e.g. multiple display units
• CPC Class Codes: A61B 5/7455 characterised by tactile indication, e.g. vibration or electrical stimulation
• 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: C12Q 1/54 : involving glucose or galactose
• CPC Class Codes: G16H 10/40 : for data related to laboratory analysis, e.g. patient specimen analysis
• CPC Class Codes: G16H 20/17 : delivered via infusion or injection
• 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
• CPC Class Codes: Y10S 128/903 : Radio telemetry
• CPC Class Codes: Y10T 29/49 : Method of mechanical manufacture
• CPC Class Codes: Y10T 29/49124 : On flat or curved insulated base, e.g., printed circuit, etc.

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. A sensor assembly to monitor an analyte, the sensor assembly comprising:

a transcutaneous electrochemical sensor comprising non-leachable, analyte-responsive enzyme; and

a sensor control unit adapted for placement on skin and adapted for receiving a portion of the transcutaneous electrochemical sensor, the sensor control unit comprising a rf transmitter that is configured and arranged to intermittently and repeatedly transmit data related to analyte-dependent signals generated by the electrochemical sensor.

2. The sensor assembly of claim 1, wherein the sensor control unit comprises at least one conductive contact and the transcutaneous electrochemical sensor comprises at least one working electrode and at least one contact pad coupled to the at least one working electrode, the at least one contact pad being disposed on a portion of the electrochemical sensor extending out of the skin, wherein the at least one conductive contact is configured and arranged to contact the at least one contact pads.

3. The sensor assembly of claim 1, wherein the sensor control unit is adapted to receive a portion of the transcutaneous electrochemical sensor extending out of the skin, the transcutaneous electrochemical sensor comprising a planar substrate.

4. The sensor assembly of claim 1, wherein the sensor control unit is adapted for placement on the skin over an insertion site of the transcutaneous electrochemical sensor.

5. The sensor assembly of claim 1, wherein the sensor control unit is water resistant.

6. The sensor assembly of claim 1, wherein the sensor control unit further comprises a battery.

7. The sensor assembly of claim 1, wherein the sensor control unit further comprises an alarm to indicate at least one of hypoglycemia, impending hypoglycemia, hyperglycemia, and impending hyperglycemia.

8. The sensor assembly of claim 1, wherein the sensor control unit further comprises a rf receiver.

9. The sensor assembly of claim 1, wherein the sensor control unit further comprises a processing circuit for determining a level of the analyte from a signal generated by the trancutaneous electrochemical sensor.

10. The sensor assembly of claim 1, wherein the analyte is glucose and the non-leachable, analyte-responsive enzyme is a non-leachable, glucose-responsive enzyme.

11. An analyte monitoring system to monitor a level of an analyte, the analyte monitoring system, comprising:

a transcutaneous electrochemical sensor comprising non-leachable, analyte-responsive enzyme;

a sensor control unit adapted for placement on skin and adapted for receiving a portion of the transcutaneous electrochemical sensor, the sensor control unit comprising a rf transmitter that is configured and arranged to intermittently and repeatedly transmit data related to analyte-dependent signals generated by the electrochemical sensor; and

a display unit comprising a rf receiver to receive the data from the sensor control unit and a display coupled to the rf receiver for displaying an indication of a level of the analyte.

12. The analyte monitoring system of claim 11, wherein the display unit further comprises a rf transmitter.

13. The analyte monitoring system of claim 12, wherein the sensor control unit further comprises a rf receiver disposed in the housing.

14. The analyte monitoring system of claim 11, wherein the display unit further comprises an input device coupled to the display.

15. The analyte monitoring system of claim 11, further comprising a calibrator for providing a calibration value to at least one of the display unit and the sensor control unit.

16. The analyte monitoring system of claim 15, wherein the calibrator comprises a part of the display unit.

17. The analyte monitoring system of claim 11, wherein the display unit is portable.

18. The analyte monitoring system of claim 11, 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.

19. The analyte monitoring system of claim 11, wherein the display unit further comprises at least one of a lamp, a radio, a clock, an interface to a computer, or a battery backup system.

20. The analyte monitoring system of claim 11, wherein the display unit further comprises a pager receiver or an interface to a telephone system to receive messages.

21. The analyte monitoring system of claim 11, wherein the display unit comprises a pager transmitter or an interface to a telephone system to send messages.

22. The analyte monitoring system of claim 21, wherein the pager transmitter or the interface to the telephone system is activated when at least one of hypoglycemia, impending hypoglycemia, hyperglycemia, or impending hyperglycemia is indicated.

23. The analyte monitoring system of claim 11, 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.

24. The analyte monitoring system of claim 11, wherein the analyte monitoring system further comprises a drug administration system which dispenses a drug based on a level of the analyte.

25. The analyte monitoring system of claim 11, wherein the analyte is glucose and the non-leachable, analyte-responsive enzyme is a non-leachable, glucose-responsive enzyme.

26. A glucose monitoring system, comprising:

a transcutaneous electrochemical glucose sensor;

a sensor control unit adapted for placement on skin and adapted for receiving a portion of the transcutaneous electrochemical glucose sensor, the sensor control unit comprising a rf transmitter that is configured and arranged to intermittently and repeatedly transmit data related to glucose-dependent signals generated by the electrochemical glucose sensor; and

a display unit comprising a rf receiver to receive the data transmitted by the transmitter and a display to display an indication of glucose concentration, wherein the display unit is configured and arranged to determine an insulin administration protocol based on the data.

27. The glucose monitoring system of claim 26, 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.

28. The glucose monitoring system of claim 27, wherein the patient-specific data comprises a response to a treatment.

29. The glucose monitoring system of claim 28, wherein the treatment is an administration of insulin.

30. The glucose monitoring system of claim 27, wherein the display unit further comprises an input device for indicating when a treatment is administered.

31. The glucose monitoring system of claim 27, wherein the processing circuit is configured to determine a drug administration protocol in response to the patient-specific data.

32. The glucose monitoring system of claim 27, wherein the patient-specific data is a dosage dependence of a response to a drug.

33. The glucose monitoring system of claim 27, wherein the display unit further comprises an input device for indicating when food has been injested.

34. The glucose monitoring system of claim 33, where the input device is configured for indicating an approximate caloric content of the food.

35. The glucose monitoring system of claim 26, further comprising a temperature measurement device to correct data obtained from the sensor.

36. The glucose monitoring system of claim 26, wherein the glucose monitoring system further comprises a drug administration system which dispenses a drug based on a level of glucose.

37. The glucose monitoring system of claim 36, 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.

38. The glucose monitoring system of claim 36, wherein the drug administration system comprises at least one of a needle, syringe, pump, catheter, inhaler, or transdermal patch to administer the drug.

39. A glucose monitoring system, comprising:

a transcutaneous electrochemical glucose sensor;

a sensor control unit adapted for placement on skin and adapted for receiving a portion of the transcutaneous electrochemical glucose sensor, the sensor control unit comprising a rf transmitter that is configured and arranged to intermittently and repeatedly transmit data related to glucose-dependent signals generated by the electrochemical glucose sensor; and

a display unit comprising a rf receiver to receive the data transmitted by the transmitter and a display to display an indication of glucose concentration, wherein the display unit is configured and arranged to analyze a plurality of glucose-dependent signals related to a particular type of episode to predict a patient'"'"'s response to future episodes of the type.

40. The glucose monitoring system of claim 39, wherein the episode comprises a response to a treatment.

41. The glucose monitoring system of claim 40, wherein the treatment is an administration of insulin.

42. The glucose monitoring system of claim 40, wherein the display unit further comprises an input device for indicating when a treatment is administered.

43. The glucose monitoring system of claim 39, wherein the display unit is configured to determine a drug administration protocol in response to the episode.

44. The glucose monitoring system of claim 39, wherein the episode is a dosage dependence of a response to a drug.

45. The glucose monitoring system of claim 39, wherein the display unit further comprises an input device for indicating when food has been injested.

46. The glucose monitoring system of claim 45, where the input device is configured for indicating an approximate caloric content of the food.

47. A method of monitoring glucose, the method comprising:

determining a glucose concentration of a patient using a glucose sensor;

collecting data including the glucose concentration in a personal display unit comprising a transmitter and a receiver;

transmitting the data to a health professional;

transmitting a message, in response to the data, from the health professional to the personal display unit; and

displaying the message from the health professional on the personal display unit.

48. The method of claim 47, further comprising inserting trancutaneously the glucose sensor prior to determining the glucose concentration.

49. The method of claim 47, wherein the glucose sensor comprises an electrochemical glucose sensor.

50. The method of claim 47, further comprising

coupling the glucose sensor to a sensor control unit, wherein the sensor control unit is configured and arranged for disposition on skin of the patient, the sensor control unit comprising a rf transmitter, and

transmitting a rf transmission signal from the sensor control unit to the personal display unit based on at least one signal generated by the glucose sensor.

51. The method of claim 50, wherein determining a glucose concentration comprises determining a glucose concentration using the personal display unit.

52. The method of claim 47, further comprising activating an alarm in the personal display unit, wherein the alarm is configured for activating under one or more of the following conditions:

hypoglycemia, impending hypoglycemia, hyperglycemia, and impending hyperglycemia.

53. The method of claim 47, wherein transmitting the data comprises transmitting the data to the health professional at regular intervals.

54. The method of claim 47, wherein transmitting the data comprises transmitting the data to the health professional when a specific condition is present, wherein the specific condition is one or more of the following:

hypoglycemia, impending hypoglycemia, hyperglycemia, and impending hyperglycemia.

55. The method of claim 47, wherein transmitting the data comprises transmitting the data using a pager or an interface to a telephone system.

56. A sensor assembly to monitor an analyte, the sensor assembly comprising:

a transcutaneous electrochemical sensor; and

a sensor control unit adapted for placement on skin, the sensor control unit comprising a power source and a rf transmitter that is configured and arranged to intermittently and repeatedly transmit data related to analyte-dependent signals generated by the electrochemical sensor, wherein the sensor control unit is configured and arranged to both deliver power to the trancutaneous electrochemical sensor and receive the analyte-dependent signals from the transcutaneous electrochemical sensor by inductive coupling between the sensor control unit and the transcutaneous electrochemical sensor.