Analyte monitoring device and methods of use

• US 8,744,545 B2
• Filed: 03/03/2009
• Issued: 06/03/2014
• Est. Priority Date: 04/30/1998
• Status: Expired due to Fees

• Current Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Inventors: Say, James, Tomasco, Michael F., Heller, Adam, Gal, Yoram, Aria, Behrad, Heller, Ephraim, Plante, Phillip John, Vreeke, Mark S., Colman, Fredric C.
• Primary Examiner(s): D'ANGELO, MICHAEL J
• Application Number:
  US12/397,293
• Publication Number:
  US 20090171179A1
• Time in Patent Office: 1,918 Days
• Field of Search: 600345-347, 600/365
• US Class Current: 600/345
• 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 computer system, comprising:

a sensor data receiving module that receives sensor data from a glucose sensor via a receiver, including one or more sensor data points;

a reference data receiving module that receives reference data from a reference glucose monitor, including one or more reference data points;

a first processor module that relates the reference data to the sensor data; and

a second processor module that determines a change of at least one characteristic of the glucose sensor, determines a rate of change of a glucose level based at least in part on the received sensor data, and determines if calibration is appropriate based at least in part on the evaluation in the change in the characteristic and if the determined rate of change of the glucose level is less than a threshold amount, wherein the second processor module evaluates the one or more sensor data points from the glucose sensor.

2. The computer system of claim 1, wherein the second processor module evaluates one of oxygen and amplitude.

3. The computer system of claim 1, further comprising an interface control module that provides output based on the change of the at least one characteristic of the glucose sensor.

4. The computer system of claim 3, wherein the output from the interface control module comprises at least one of a numeric estimated glucose value, an indication of directional trend of glucose concentration, and a graphical representation of an estimated glucose value.

5. The computer system of claim 1, wherein the reference data receiving module is adapted to receive the reference data from a blood glucose test.

6. The computer system of claim 1, wherein the reference data receiving module is adapted to receive the reference data from an internal reference glucose monitor that is housed integrally within the computer system.

7. The computer system of claim 1, wherein the second processor module evaluates an amplitude of a signal related to the one or more sensor data points.

8. The computer system of claim 1, further comprising an interface control module comprising alerts configured to warn a user of a present and/or upcoming hypoglycemic and/or hyperglycemic event.

9. The computer system of claim 1, further comprising a third processor module configured to predict one or more glucose values at one or more future points in time.

10. The computer system of claim 1, further comprising an interface control module configured to send the sensor data to an insulin pump.

11. The computer system of claim 1, wherein the second processor module is configured to confirm an accuracy of the one or more sensor data points of the glucose sensor.

12. The computer system of claim 1, wherein the glucose sensor includes a plurality of electrodes comprising at least one working electrode, the working electrode including an analyte-responsive enzyme and a mediator, and at least one of the analyte-responsive enzyme and the mediator is chemically bonded to a polymer disposed on the working electrode, and further wherein at least one of the analyte-responsive enzyme and the mediator is crosslinked with the polymer.

13. A method, comprising:

receiving sensor data from a glucose sensor, including one or more sensor data points;

relating reference data to the sensor data;

determining a rate of change of a glucose level based at least in part on the received sensor data;

determining using processing circuitry if calibration of the glucose sensor is appropriate based at least in part by evaluating a change in a characteristic associated with the glucose sensor and determining if the rate of change of the glucose level is less than a threshold amount; and

providing output reflective of the sensor data after the change in the characteristic has been determined, wherein determining the change in the characteristic of the glucose sensor comprises evaluating the one or more sensor data points received from the glucose sensor.

14. The method of claim 13, wherein determining the change in the characteristic of the glucose sensor comprises waiting a predetermined time period between about ten and thirty minutes.

15. The method of claim 13, wherein determining the change in the characteristic of the glucose sensor comprises evaluating one of oxygen and amplitude.

16. The method of claim 13, wherein the step of providing output comprises providing at least one of an audible, visual, or tactile output based on the change in the characteristic of the glucose sensor.

17. The method of claim 16, wherein the step of providing output based on the change in the characteristic of the glucose sensor comprises indicating at least one of a numeric estimated glucose value, a directional trend of glucose concentration, and a graphical representation of an estimated glucose value.

18. The method of claim 13, further comprising receiving the reference data from a reference glucose monitor.

19. The method of claim 18, wherein receiving the reference data from the reference glucose monitor comprises receiving a wired internal communication.

20. The method of claim 13, wherein providing output comprises alerting a user of a present and/or upcoming hypoglycemic and/or hyperglycemic event.

21. The method of claim 13, further comprising predicting one or more glucose values at one or more future points in time.

22. The method of claim 13, wherein providing output comprises sending the sensor data to an insulin pump.

23. The method of claim 13, wherein determining the change in the characteristic of the glucose sensor further comprises confirming an accuracy of the one or more sensor data points of the glucose sensor.

24. The method of claim 13, wherein the glucose sensor includes a plurality of electrodes comprising at least one working electrode, the working electrode including an analyte-responsive enzyme and a mediator, and at least one of the analyte-responsive enzyme and the mediator is chemically bonded to a polymer disposed on the working electrode, and further wherein at least one of the analyte-responsive enzyme and the mediator is crosslinked with the polymer.

25. A system, comprising:

a sensor data module operatively linked to a glucose sensor and configured to receive sensor data from the glucose sensor; and

a processor module associated with the sensor data module and programmed to relate reference data points with sensor data points and to determine a rate of change of a glucose level based at least in part on the received sensor data, wherein the processor module is programmed to determine if calibration of the glucose sensor is appropriate by evaluating a change in a characteristic of the glucose sensor and determining if the rate of change of the glucose level is less than a threshold amount, and wherein the processor module is further programmed to output information reflective of the sensor data after it has been determined that calibration of the glucose sensor is appropriate, wherein the processor module is programmed to evaluate the sensor data from the glucose sensor to determine the change in the characteristic.

26. The system of claim 25, wherein the change in the characteristic is based on a time period since the glucose sensor was implanted.

27. The system of claim 25, wherein the processor module is programmed to evaluate one of oxygen and amplitude.

28. The system of claim 25, further comprising an output module associated with the processor module and programmed to control output of sensor data.

29. The system of claim 28, wherein the output of sensor data indicates at least one of a numeric estimated glucose value, a directional trend of glucose concentration, and a graphical representation of an estimated glucose value.

30. The system of claim 25, further comprising a reference input module configured to receive reference data from a blood glucose test, wherein the reference data comprises one or more reference data points.

31. The system of claim 25, further comprising a reference glucose monitor integral with the system and wherein the system further comprises a reference input module configured to receive an internal communication from the reference glucose monitor, wherein the internal communication comprises one or more reference data points.

32. The system of claim 25, wherein the processor module is programmed to evaluate an amplitude of a signal related to the sensor data.

33. The system of claim 25, further comprising an output module comprising alerts configured to warn a user of a present and/or upcoming hypoglycemic and/or hyperglycemic event.

34. The system of claim 25, wherein the processor module is configured to predict one or more glucose values at one or more future points in time.

35. The system of claim 25, further comprising an output module configured to send the sensor data to an insulin pump.

36. The system of claim 25, wherein the processor module is programmed to confirm an accuracy of the sensor data of the glucose sensor to determine the change in the characteristic.

37. The system of claim 25, wherein the glucose sensor includes a plurality of electrodes comprising at least one working electrode, the working electrode including an analyte-responsive enzyme and a mediator, and at least one of the analyte-responsive enzyme and the mediator is chemically bonded to a polymer disposed on the working electrode, and further wherein at least one of the analyte-responsive enzyme and the mediator is crosslinked with the polymer.