ANALYTE MONITORING DEVICE AND METHODS OF USE

• US 20100324400A1
• Filed: 08/06/2010
• Published: 12/23/2010
• Est. Priority Date: 04/30/1998
• Status: Active Grant

• Current Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories)
• Original Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories)
• Inventors: Colman, Fredric C., Heller, Ephraim, Heller, Adam, Say, James, Gal, Yoram, Aria, Behrad, Plante, Phillip John, Vreeke, Mark S., Friedman, Keith A., Tomasco, Michael F.
• Granted Patent: US 7,885,699 B2
• Time in Patent Office: Days
• 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. An in vivo glucose monitoring system comprising:

two in vivo working electrodes; and

a receiver unit external to a user in signal communication with the two in vivo working electrodes, the receiver unit comprising;

one or more processors; and

a computer-readable storage medium including instructions which, when executed by the one or more processors, causes the one or more processors to;

receive signals from both of the working electrodes indicative of a glucose level of the user;

process the signals received from both of the working electrodes; and

determine the acceleration of the rate of change of the glucose level.

2. The system of claim 1, wherein the computer-readable storage medium further includes instructions which, when executed by the one or more processors, causes the one or more processors to determine whether the acceleration of the rate of change of the glucose level exceeds or meets one or more threshold values.

3. The system of claim 2, wherein the receiver unit further comprises an alarm, and wherein the computer-readable storage medium further includes instructions which, when executed by the one or more processors, causes the one or more processors to activate the alarm when the acceleration of the rate of change of the glucose level exceeds or meets the one or more threshold values.

4. The system of claim 3, wherein the computer-readable storage medium further includes instructions which, when executed by the one or more processors, causes the alarm to automatically deactivate when the acceleration of the rate of change of the glucose level no longer exceeds or meets the one or more threshold values.

5. The system of claim 3, wherein the computer-readable storage medium further includes instructions which, when executed by the one or more processors, causes the alarm to automatically deactivate when a single datapoint indicates that the acceleration of the rate of change of the glucose level no longer exceeds or meets the one or more threshold values.

6. The system of claim 3, wherein the computer-readable storage medium further includes instructions which, when executed by the one or more processors, causes the alarm to automatically deactivate when a predetermined number of datapoints obtained over a period of time indicates that the acceleration of the rate of change of the glucose level no longer exceeds or meets the one or more threshold values.

7. The system of claim 3, wherein the computer-readable storage medium further includes instructions which, when executed by the one or more processors, causes the alarm to automatically deactivate when an average of datapoints obtained over a period of time indicates that the acceleration of the rate of change of the glucose level no longer exceeds or meets the one or more threshold values.

8. The system of claim 3, wherein the computer-readable storage medium further includes instructions which, when executed by the one or more processors, causes the alarm to automatically deactivate after a predetermined period of time.

9. The system of claim 1, wherein the receiver unit further comprises a display, the display configured to display information related to the acceleration of the rate of change of the glucose level.

10. The system of claim 1, wherein the two working electrodes are both disposed on one analyte sensor.

11. The system of claim 1, wherein the two working electrodes are each disposed on different analyte sensors.

12. The system of claim 1, wherein the instructions to process the signals received from both of the working electrodes includes instructions to average the signals of both of the working electrodes.

13. The system of claim 1, wherein a first of the two working electrodes includes a sensing layer disposed thereon and a second of the two working electrodes does not include a sensing layer.

14. The system of claim 13, wherein the instructions to process the signals received from both of the working electrodes includes instructions to subtract the signal associated with the second working electrode from the signal associated with the first working electrode.

15. The system of claim 14, wherein the signal associated with the second working electrode corresponds to a background signal.

16. An in vivo glucose monitoring system, comprising:

two in vivo working electrodes; and

a receiver unit external to a user in signal communication with the two in vivo working electrodes, the receiver unit comprising;

one or more processors; and

a computer-readable storage medium including instructions which, when executed by the one or more processors, causes the one or more processors to;

receive signals from the two working electrodes indicative of a glucose level of the user;

compare the signals received from the two working electrodes;

discard one of the signals received from the two working electrodes after the comparison; and

determine the acceleration of the rate of change of the glucose level using the non-discarded signal.

17. The system of claim 16, wherein the computer-readable storage medium further includes instructions which, when executed by the one or more processors, causes the one or more processors to determine whether the acceleration of the rate of change of the glucose level exceeds or meets one or more threshold values.

18. The system of claim 17, wherein the receiver unit further comprises an alarm, and wherein the computer-readable storage medium further includes instructions which, when executed by the one or more processors, causes the one or more processors to activate the alarm when the acceleration of the rate of change of the glucose level exceeds or meets the one or more threshold values.

19. The system of claim 18, wherein the computer-readable storage medium further includes instructions which, when executed by the one or more processors, causes the alarm to automatically deactivate when the acceleration of the rate of change of the glucose level no longer exceeds or meets the one or more threshold values.

20. The system of claim 18, wherein the computer-readable storage medium further includes instructions which, when executed by the one or more processors, causes the alarm to automatically deactivate when a single datapoint indicates that the acceleration of the rate of change of the glucose level no longer exceeds or meets the one or more threshold values.

21. The system of claim 18, wherein the computer-readable storage medium further includes instructions which, when executed by the one or more processors, causes the alarm to automatically deactivate when a predetermined number of datapoints obtained over a period of time indicates that the acceleration of the rate of change of the glucose level no longer exceeds or meets the one or more threshold values.

22. The system of claim 18, wherein the computer-readable storage medium further includes instructions which, when executed by the one or more processors, causes the alarm to automatically deactivate when an average of datapoints obtained over a period of time indicates that the acceleration of the rate of change of the glucose level no longer exceeds or meets the one or more threshold values.

23. The system of claim 18, wherein the computer-readable storage medium further includes instructions which, when executed by the one or more processors, causes the alarm to automatically deactivate after a predetermined period of time.

24. The system of claim 18, wherein the computer-readable storage medium further includes instructions which, when executed by the one or more processors, causes the one or more processors to activate the alarm when the compared signals received from the two working electrodes are not within a predetermined level of tolerance.

25. The system of claim 16, wherein the receiver unit further comprises a display, the display configured to display information related to the acceleration of the rate of change of the glucose level.

26. The system of claim 16, wherein the two working electrodes are both disposed on one analyte sensor.

27. The system of claim 16, wherein the two working electrodes are each disposed on different analyte sensors.

28. The system of claim 16, wherein one of the working electrodes comprises a sensing layer and the other working electrode does not have a sensing layer.

29. An in vivo glucose monitoring system comprising:

a first in vivo working electrode including a first sensing layer disposed thereon, wherein the first sensing layer is configured to electrolyze glucose;

a second in vivo working electrode including a second sensing layer disposed thereon, wherein the second sensing layer does not include one or more components needed to electrolyze glucose; and

a receiver unit external to a user in signal communication with the first and second in vivo working electrodes, the receiver unit comprising;

one or more processors; and

a computer-readable storage medium including instructions which, when executed by the one or more processors, causes the one or more processors to;

receive signals from the first and second working electrodes indicative of a glucose level of the user;

subtract the signal received from the second electrode from the signal received from first electrode to obtain an adjusted signal; and

determine the acceleration of the rate of change of the glucose level using the adjusted signal.

30. The system of claim 29, wherein the computer-readable storage medium further includes instructions which, when executed by the one or more processors, causes the one or more processors to determine whether the acceleration of the rate of change of the glucose level exceeds or meets one or more threshold values.

31. The system of claim 30, wherein the receiver unit further comprises an alarm, and wherein the computer-readable storage medium further includes instructions which, when executed by the one or more processors, causes the one or more processors to activate the alarm when the acceleration of the rate of change of the glucose level exceeds or meets the one or more threshold values.

32. The system of claim 31, wherein the computer-readable storage medium further includes instructions which, when executed by the one or more processors, causes the alarm to automatically deactivate when the acceleration of the rate of change of the glucose level no longer exceeds or meets the one or more threshold values.

33. The system of claim 31, wherein the computer-readable storage medium further includes instructions which, when executed by the one or more processors, causes the alarm to automatically deactivate when a single datapoint indicates that the acceleration of the rate of change of the glucose level no longer exceeds or meets the one or more threshold values.

34. The system of claim 31, wherein the computer-readable storage medium further includes instructions which, when executed by the one or more processors, causes the alarm to automatically deactivate when a predetermined number of datapoints obtained over a period of time indicates that the acceleration of the rate of change of the glucose level no longer exceeds or meets the one or more threshold values.

35. The system of claim 31, wherein the computer-readable storage medium further includes instructions which, when executed by the one or more processors, causes the alarm to automatically deactivate when an average of datapoints obtained over a period of time indicates that the acceleration of the rate of change of the glucose Ivel no longer exceeds or meets the one or more threshold values.

36. The system of claim 31, wherein the computer-readable storage medium further includes instructions which, when executed by the one or more processors, causes the alarm to automatically deactivate after a predetermined period of time.

37. The system of claim 29, wherein the receiver unit further comprises a display, display configured to display information related to the acceleration of the rate of change of the glucose level.

38. The system of claim 29, wherein the two working electrodes are both disposed on one analyte sensor.

39. The system of claim 29, wherein the two working electrodes are each disposed on different analyte sensors.

40. The system of claim 29, wherein the signal received from the second working electrode corresponds to a background signal.

41. The system of claim 29, wherein the first sensing layer includes an electron transfer agent and a catalyst and the second sensing layer does not include one or both of the electron transfer agent or the catalyst.

42. The system of claim 41, wherein the electron transfer agent and the catalyst are non-leachable.