Method and apparatus for providing data processing and control in medical communication system

• US 9,615,780 B2
• Filed: 04/14/2008
• Issued: 04/11/2017
• Est. Priority Date: 04/14/2007
• Status: Active Grant

• Current Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories)
• Original Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories)
• Inventors: Hayter, Gary
• Primary Examiner(s): Brusca, John S
• Application Number:
  US12/102,847
• Publication Number:
  US 20080256048A1
• Time in Patent Office: 3,284 Days
• Field of Search: None
• CPC Class Codes: A61B 2560/0252 using ambient temperature
• CPC Class Codes: A61B 2560/0271 using a remote monitoring unit
• 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 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• 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 5/6867 specially adapted to be attached or implanted in a specific body part A61B5/6847 takes precedence
• CPC Class Codes: A61B 5/74 Details of notification to user or communication with user or patient indicating measured values G01D7/00; user input means input or output arrangements for computers G06F3/00
• CPC Class Codes: A61B 5/7405 using sound
• CPC Class Codes: A61B 5/742 using visual displays A61B5/339 takes precedence
• CPC Class Codes: A61B 5/746 Alarms related to a physiological condition, e.g. details of setting alarm thresholds or avoiding false alarms alarms per se G08B
• CPC Class Codes: C12Q 1/54 involving glucose or galactose

Abstract

Methods and apparatus for providing data processing and control for use in a medical communication system are provided.

Claims

1. A method, comprising:

generating with an analyte sensor a plurality of signals, wherein the plurality of signals have a signal characteristic independent of a measured analyte level of a user;

determining, using an analyte monitoring device electrically coupled to the analyte sensor and in signal communication with the analyte sensor, whether the signal characteristic of the plurality of generated signals deviates from a predetermined signal characteristic corresponding to signal characteristics of a predetermined operational state of the analyte monitoring device, wherein the predetermined operational state corresponds to an individual one of a plurality of operational states of the analyte monitoring device, wherein each of the plurality of operational states have a corresponding signal characteristic, wherein the plurality of operational states includes an analyte sensor removal state and an analyte sensor insertion state;

setting a present operational state of the analyte monitoring device based on the signal characteristic of the plurality of generated signals, wherein if the signal characteristic of the plurality of generated signals deviate from the predetermined signal characteristic corresponding to the predetermined operational state the present operational state will differ from the predetermined operational state;

presenting an output data associated with an operational state of the analyte monitoring device and based at least in part on an analysis of one or more of the plurality of generated signals relative to a prior generated signal;

and

determining a new operational state of the analyte monitoring device based upon user input in response to the output data.

2. The method of claim 1, wherein the predetermined signal characteristic further includes one or more of a signal level transition from below a first predetermined level to above the first predetermined level, a signal level transition from above a second predetermined level to below the second predetermined level, a transition from below a predetermined signal rate of change threshold to above the predetermined signal rate of change threshold, or a transition from above the predetermined signal rate of change threshold to below the predetermined signal rate of change threshold.

3. The method of claim 2, wherein the first predetermined level and the second predetermined level each includes one of approximately 9 ADC counts or approximately 18 ADC counts.

4. The method of claim 1, wherein the predetermined signal characteristic includes a transition from below a predetermined level to above and wherein the signal is maintained above the predetermined level for a predetermined period of time.

5. The method of claim 4, wherein the predetermined period of time includes one of approximately 10 seconds, 30 seconds, less than 30 seconds, or greater than 30 seconds.

6. The method of claim 1, wherein the output data includes a user notification alert.

7. The method of claim 1, wherein the output data includes an indicator to start one or more processing timers associated with a respective one or more data processing routines.

8. The method of claim 7, wherein the one or more processing timers includes a respective one of a calibration timer, or a sensor expiration timer.

9. The method of claim 1, wherein the user input data includes a user confirmation of a transition to the new operational state.

10. The method of claim 1, including transitioning from the present operational state to the new operational state.

11. The method of claim 10, wherein the transitioning from the present operational state to the new operational state is based on the received user input data, or based on the generated output data.

12. The method of claim 1, wherein presenting the output data includes one or more of visually presenting the output data, audibly presenting the output data, vibratorily presenting the output data, or one or more combinations thereof.

13. The method of claim 1, wherein the analyte level includes glucose level of a user.

14. The method of claim 1, wherein the new operational state includes one of an analyte sensor removal state, an analyte sensor insertion state, an analyte sensor dislocation state, an analyte sensor insertion with an associated transient signal state, or an analyte sensor insertion with an associated stabilized signal state.

20. The method of claim 1, including transitioning from the present operational state to the new operational state associated with the analyte monitoring device, and executing one or more routines associated with the new operational state.

22. The method of claim 4, wherein the predetermined time period is 90 seconds or less.

23. The method of claim 1, wherein the predetermined signal characteristic comprises a predetermined analog to digital conversion (ADC) count, wherein the predetermined ADC count includes 9 ADC counts over a predetermined time period.

26. The method of claim 1, wherein the plurality of operational states further includes a new analyte sensor insertion state.

15. A data processing device, comprising:

a storage unit;

a user interface unit; and

a data processor operatively coupled to the user interface unit and the storage unit, the data processor configured to;

receive a plurality of signals generated by an analyte sensor, wherein the plurality of signals have a signal characteristic independent of a measured analyte level of a user, the analyte sensor in signal communication with the data processor;

determine whether the signal characteristic of the plurality of generated signals deviates from a predetermined signal characteristic corresponding to signal characteristics of a predetermined operational state of the analyte monitoring device, wherein the predetermined operational state of the analyte monitoring device corresponds to an individual one of a plurality of operational states of the analyte monitoring device, wherein each of the plurality of operational states have a corresponding signal characteristic, wherein the plurality of operational states includes an analyte sensor removal state and an analyte sensor insertion state;

set a present operational state of the analyte monitoring device based on the signal characteristic of the plurality of generated signals, wherein if the signal characteristic of the plurality of generated signals deviate from the predetermined signal characteristic corresponding to the predetermined operational state the present operational state will differ from the predetermined operational state;

present in the user interface unit an output data associated with an operational state of the analyte monitoring device and based at least in part on an analysis of one or more of the plurality of generated signals relative to a prior generated signal;

and

determine a new operational state associated with an analyte monitoring device based upon user input in response to the output data.

16. The device of claim 15, wherein the user interface unit includes one or more of a user input unit, a visual display unit, an audible output unit, a vibratory output unit, or a touch sensitive user input unit.

17. The device of claim 16, including a communication unit operatively coupled to the data processor and configured to communicate one or more of the received signal, the prior signal, and the output data.

18. The device of claim 17, wherein the communication unit includes one of an RF transmitter, an RF receiver, an infrared data communication device, or a short-range data communication device.

19. The device of claim 16, including a storage unit operatively coupled to the data processor to store one or more of the received signal associated with the analyte level, the predetermined signal characteristic, the prior signal, the output data, and the new operational state associated with the analyte monitoring device.

21. The device of claim 15, wherein the data processor is further configured to transition from the present operational state to the new operational state associated with the analyte monitoring device, and execute one or more routines associated with the new operational state.

24. The device of claim 15, wherein the predetermined signal characteristic includes a transition from below a predetermined level to above and wherein the signal is maintained above the predetermined level for a predetermined period of time, wherein the predetermined time period is 90 seconds or less.

25. The device of claim 15, wherein the predetermined signal characteristic comprises a predetermined analog to digital conversion (ADC) count, wherein the predetermined ADC count includes 9 ADC counts over a predetermined time period.

27. The device of claim 15, wherein the plurality of operational states further includes a new analyte sensor insertion state.