Analyte Monitoring Device And Methods Of Use

• US 20100241388A1
• Filed: 06/03/2010
• Published: 09/23/2010
• Est. Priority Date: 04/30/1998
• Status: Abandoned Application

• Current Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories)
• Original Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories)
• Inventors: Heller, Ephraim, Heller, Adam, Say, James, Gal, Yoram, Colman, Fredric C., Aria, Behrad, Plante, Phillip John, Vreeke, Mark S., Friedman, Keith A., Tomasco, Michael F.
• Application Number:
  US12/793,662
• Publication Number:
  US 20100241388A1
• Time in Patent Office: Days
• US Class Current: 702/104
• 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. (canceled)

2. A system for evaluating a change in a sensitivity of an analyte sensor over a predetermined time period, the system comprising:

an analyte sensor; and

a computer system, wherein the computer system comprises;

an input module configured to receive sensor analyte data and reference analyte data, wherein the sensor data comprises one or more sensor analyte values measured in a biological sample of a host and wherein the reference data comprises one or more reference analyte values; and

a processor module configured to intermittently calculate a sensitivity of the analyte sensor based at least in part on the reference analyte data and to evaluate a change in sensitivity by evaluating a plurality of time spaced sensitivity calculations over a predetermined time period.

3. The system of claim 2, wherein the processor module is configured to evaluate the change in sensitivity at least in part by evaluating at least two sensitivity measurements during the predetermined time period.

4. The system of claim 3, wherein the processor module is further configured to average or filter the at least two sensitivity measurements prior to evaluating the at least two sensitivity measurements.

5. The system of claim 2, wherein the processor module is further configured to compare the change in sensitivity with one or more criteria.

6. The system of claim 5, wherein the processor module is further configured to use a most recent sensitivity calculation evaluated to calibrate the analyte sensor when the change in sensitivity meets one or more criteria.

7. The system of claim 5, wherein the processor module is further configured to not use a most recent sensitivity calculation evaluated to calibrate the analyte sensor when the change in sensitivity does not meet one or more criteria.

8. The system of claim 2, wherein the predetermined time period is at least about 30 minutes.

9. The system of claim 8, wherein the predetermined time period is at least about 60 minutes.

10. The system of claim 9, wherein the predetermined time period is at least about 120 minutes.

11. The system of claim 8, wherein the processor module is configured to iteratively evaluate a sensitivity of the plurality of time spaced sensitivity calculations over the predetermined time period.

12. The system of claim 8, wherein the processor module is configured to evaluate all sensitivity calculations over a sensor session.

13. The system of claim 8, wherein the processor module is configured to evaluate a sensitivity based at least in part on a priori sensitivity information.

14. The system of claim 13, wherein the a priori sensitivity information is an expected profile.

15. The system of claim 13, wherein the a priori sensitivity information defines a range of acceptable change in sensitivity.

16. The system of claim 2, wherein the analyte sensor data comprises a first signal comprising an analyte component and a baseline component and a second signal comprising a baseline component without an analyte component.

17. The system of claim 16, wherein the processor module is configured to calculate a sensitivity of the analyte sensor based at least in part on the first signal.

18. The system of claim 16, wherein the processor module is configured to calculate a sensitivity of the analyte sensor based at least in part on the second signal.

19. The system of claim 16, wherein the processor module is further configured to calculate a sensitivity of the analyte sensor based at least in part on a subtracted signal, wherein the subtracted signal comprises the second signal subtracted from the first signal.

20. The system of claim 2, wherein the processor module is configured to intermittently calculate a sensitivity of the analyte sensor based at least in part on a signal obtained when the analyte sensor is exposed to the biological sample.

21. The system of claim 2, wherein the processor module is configured to intermittently calculate a sensitivity of the analyte sensor based at least in part on a signal obtained when the analyte sensor is exposed to a reference solution.

22. The system of claim 2, wherein the processor module is configured to intermittently calculate a sensitivity of the analyte sensor based on a signal obtained when the analyte sensor is exposed to the biological sample and a signal obtained when the analyte sensor is exposed to a reference solution.

23. A system for evaluating a change in a sensitivity of an analyte sensor over a predetermined time period, the system comprising:

an analyte sensor; and

a computer system, wherein the computer system comprises;

an input module configured to receive sensor analyte data and reference analyte data, wherein the sensor data comprises one or more sensor analyte values measured in a biological sample of a host and wherein the reference data comprises one or more reference analyte values; and

a processor module configured to intermittently calculate a sensitivity of the analyte sensor based at least in part on the reference analyte data.

24. The system of claim 23 wherein the processor module is configured to evaluate a change in sensitivity.

25. The system of claim 23, wherein the processor module is configured to evaluate a change in sensitivity by evaluating a plurality of time spaced sensitivity calculations over a predetermined time period.

26. The system of claim 23, wherein the processor module is configured to evaluate the change in sensitivity at least in part by evaluating at least two sensitivity measurements during the predetermined time period.

27. The system of claim 26, wherein the processor module is further configured to average or filter the at least two sensitivity measurements.

28. The system of claim 27 wherein the processor module is further configured to average or filter the at least two sensitivity measurements prior to evaluating the at least two sensitivity measurements.

29. The system of claim 23, wherein the processor module is further configured to compare the change in sensitivity with one or more criteria.

30. The system of claim 29, wherein the processor module is further configured to use a most recent sensitivity calculation evaluated to calibrate the analyte sensor when the change in sensitivity meets one or more criteria.

31. The system of claim 29, wherein the processor module is further configured to not use a most recent sensitivity calculation evaluated to calibrate the analyte sensor when the change in sensitivity does not meet one or more criteria.

32. The system of claim 23, wherein the predetermined time period is at least about 30 minutes.

33. The system of claim 32, wherein the predetermined time period is at least about 60 minutes.

34. The system of claim 33, wherein the predetermined time period is at least about 120 minutes.

35. The system of claim 32, wherein the processor module is configured to evaluate a sensitivity of the plurality of time spaced sensitivity calculations.

36. The system of claim 35, wherein the processor module is configured to iteratively evaluate a sensitivity of the plurality of time spaced sensitivity calculations.

37. The system of claim 35, wherein the processor module is configured to evaluate a sensitivity of the plurality of time spaced sensitivity calculations over the predetermined time period.

38. The system of claim 32, wherein the processor module is configured to evaluate all sensitivity calculations over a sensor session.

39. The system of claim 32, wherein the processor module is configured to evaluate a sensitivity based at least in part on a priori sensitivity information.

40. The system of claim 39, wherein the a priori sensitivity information is an expected profile.

41. The system of claim 39, wherein the a priori sensitivity information defines a range of acceptable change in sensitivity.

42. The system of claim 23, wherein the analyte sensor data comprises a first signal comprising an analyte component and a baseline component or a second signal comprising a baseline component without an analyte component.

43. The system of claim 42, wherein the processor module is configured to calculate a sensitivity of the analyte sensor based at least in part on the first signal.

44. The system of claim 42, wherein the processor module is configured to calculate a sensitivity of the analyte sensor based at least in part on the second signal.

45. The system of claim 42, wherein the processor module is further configured to calculate a sensitivity of the analyte sensor based at least in part on a subtracted signal, wherein the subtracted signal comprises the second signal subtracted from the first signal.

46. The system of claim 23, wherein the processor module is configured to calculate a sensitivity of the analyte sensor based at least in part on a signal obtained when the analyte sensor is exposed to the biological sample.

47. The system of claim 46, wherein the processor module is configured to intermittently calculate the sensitivity of the analyte sensor based at least in part on the signal obtained when the analyte sensor is exposed to the biological sample.

48. The system of claim 23, wherein the processor module is configured to calculate a sensitivity of the analyte sensor based at least in part on a signal obtained when the analyte sensor is exposed to a reference solution.

49. The system of claim 23, wherein the processor module is configured to intermittently calculate the sensitivity of the analyte sensor based at least in part on the signal obtained when the analyte sensor is exposed to a reference solution.

50. The system of claim 23, wherein the processor module is configured to calculate a sensitivity of the analyte sensor based on a signal obtained when the analyte sensor is exposed to the biological sample or a signal obtained when the analyte sensor is exposed to a reference solution.

51. The system of claim 23, wherein the processor module is configured to intermittently calculate the sensitivity of the analyte sensor based on the signal obtained when the analyte sensor is exposed to the biological sample or the signal obtained when the analyte sensor is exposed to a reference solution.