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

• US 9,125,548 B2
• Filed: 05/14/2008
• Issued: 09/08/2015
• Est. Priority Date: 05/14/2007
• 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): CANELLA, KAREN A
• Application Number:
  US12/152,657
• Publication Number:
  US 20080287763A1
• Time in Patent Office: 2,673 Days
• Field of Search: None
• US Class Current: 1/1
• CPC Class Codes: A61B 2560/0242 adapted to measure environmental factors, e.g. temperature, pollution
• 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 5/14503 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 5/1473 invasive, e.g. introduced into the body by a catheter A61B5/1482 takes precedence
• CPC Class Codes: A61B 5/1495 Calibrating or testing of in-vivo probes
• CPC Class Codes: A61B 5/7221 Determining signal validity, reliability or quality A61B5/7207 and A61B5/7217 take precedence
• CPC Class Codes: A61B 5/7275 Determining trends in physiological measurement data; Predicting development of a medical condition based on physiological measurements, e.g. determining a risk factor
• 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 5/7455 characterised by tactile indication, e.g. vibration or electrical stimulation

Abstract

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

Claims

1. A method comprising:

transcutaneously positioning an in vivo analyte sensor in fluid contact with interstitial fluid under a skin layer, the analyte sensor configured to generate a plurality of signals corresponding to a monitored analyte level in the interstitial fluid over a predetermined time period;

generating one or more data packets from the plurality of signals generated by the analyte sensor in fluid contact with the interstitial fluid;

communicating the generated one or more data packets to a remote location;

monitoring at the remote location, the one or more data packets for one or more predetermined conditions associated with the one or more data packets during the predetermined time period;

categorizing the one or more data packets into at least one bin that corresponds to a rate of change of the analyte level monitored over the predetermined time period, wherein a position of a trend indicator is associated with the at least one bin;

changing a characteristic of an output display of the trend indicator when an uncertainty parameter associated with time spacing between current and prior signals in the generated one or more data packets exceeds a predetermined threshold level, the uncertainty parameter being dynamically modified based on the time spacing between the current and prior signals in the one or more data packets; and

outputting a notification when the one or more predetermined conditions associated with the one or more data packets is detected, wherein the one or more predetermined conditions are associated with an adverse data condition associated with the analyte sensor.

2. The method of claim 1, wherein the one or more predetermined conditions includes an out of range temperature value associated with the detected one or more data packets, a persistent low detected one or more data packets, or an error condition of the analyte sensor.

3. The method of claim 2, wherein the persistent low detected one or more data packets includes at least two consecutive signals from the detected one or more data packets that are below a predetermined signal level.

4. The method of claim 3, wherein the predetermined signal level is associated with a failed analyte sensor state.

5. The method of claim 2, wherein the error condition of the analyte sensor includes unacceptable data quality of the detected one or more data packets.

6. The method of claim 1, wherein the notification is output when the same one or more predetermined conditions are detected more than once during the predetermined time period.

7. The method of claim 1, wherein outputting the notification includes one or more of displaying the generated output notification, audibly outputting the generated output notification or vibratorily outputting the generated output notification.

8. The method of claim 1, wherein the predetermined time period is less than approximately one hour from the positioning of the analyte sensor in continuous contact with the interstitial fluid under the skin surface.

9. The method of claim 1, wherein the notification includes an indication to replace the analyte sensor.

10. The method of claim 1, wherein the output display of the trend indicator depicts a change in the analyte level.

11. The method of claim 1, wherein a change in the characteristic of the output display of the trend indicator includes not displaying the output display of the trend indicator.

12. The method of claim 1, wherein the change in the characteristic of the output display of the trend indicator includes a flashing of the output display of the trend indicator.

13. The method of claim 1, wherein the change in the characteristic of the output display of the trend indicator includes at least one of a change in color, a change in shape, or a change in size of the output display of the trend indicator.

14. The method of claim 1, wherein the change in the characteristic of the output display of the trend indicator includes at least one of a change in a length or a change in a width of the output display of the trend indicator.

15. An analyte monitoring system comprising:

an in vivo analyte sensor at least a portion of which is configured to be positioned under a skin layer and in fluid contact with interstitial fluid, the analyte sensor configured to generate a plurality of signals corresponding to a monitored analyte level in the interstitial fluid over a predetermined time period; and

a processing unit operatively coupled to the analyte sensor, the processing unit configured to receive one or more data packets generated from the plurality of signals generated by the analyte sensor, to categorize the one or more data packets into at least one bin that corresponds to a rate of change of the analyte level monitored over the predetermined time period, wherein a position of a trend indicator is associated with the at least one bin, to change a characteristic of an output display of the trend indicator when an uncertainty parameter associated with time spacing between current and prior signals in the generated one or more data packets exceed a predetermined threshold level, the uncertainty parameter being dynamically modified based on the time spacing between the current and prior signals in the one or more data packets, and to generate a notification for output when one or more predetermined conditions associated with the one or more data packets is detected, wherein the one or more predetermined conditions are associated with an adverse data condition associated with the analyte sensor.

16. The system of claim 15, wherein the one or more predetermined conditions includes an out of range temperature value associated with the detected one or more data packets, a persistent low detected one or more data packets, or an error condition of the analyte sensor.

17. The system of claim 16, wherein the persistent low detected one or more data packets includes at least two consecutive signals from the detected one or more data packets that are below a predetermined signal level.

18. The system of claim 17, wherein the predetermined signal level is associated with a failed analyte sensor state.

19. The system of claim 16, wherein the error condition of the analyte sensor includes unacceptable data quality of the detected one or more data packets.

20. The system of claim 15, including an output unit operatively coupled to the processing unit, the output unit configured to output the notification when the same one or more predetermined conditions are detected more than once during the predetermined time period.

21. The system of claim 20, wherein the output unit is configured to output a visual output signal, an audible output signal or a vibratory output signal corresponding to the notification.

22. The system of claim 15, wherein the predetermined time period is less than approximately one hour from the positioning of the analyte sensor in continuous contact with the interstitial fluid under the skin surface.

23. The system of claim 20, wherein the output notification includes an indication to replace the analyte sensor.

24. The system of claim 15, wherein the output display of the trend indicator depicts a change in the analyte level.

25. The system of claim 15, wherein the change in the characteristic of the output display of the trend indicator includes not displaying the output display of the trend indicator.

26. The system of claim 15, wherein the change in the characteristic of the output display of the trend indicator includes a flashing of the output display of the trend indicator.

27. The system of claim 15, wherein the change in the characteristic of the output display of the trend indicator includes at least one of a change in color, a change in shape, or a change in size of the output display of the trend indicator.

28. The system of claim 15, wherein the change in the characteristic of the output display of the trend indicator includes at least one of a change in a length or a change in a width of the output display of the trend indicator.