System for improved interpretation of physiological data and presentation of physiological condition management information

• US 10,398,379 B2
• Filed: 12/14/2012
• Issued: 09/03/2019
• Est. Priority Date: 12/15/2011
• Status: Active Grant

• Current Assignee: Becton, Dickinson & Co
• Original Assignee: Becton, Dickinson & Co
• Inventors: Petisce, James, DiResta, Ellen, Burns, Deborah, Mason, David, Kanderian, Sami
• Primary Examiner(s): Riggs, II, Larry D
• Application Number:
  US14/364,897
• Publication Number:
  US 20140379273A1
• Time in Patent Office: 2,454 Days
• Field of Search: None
• 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 5/02438 with portable devices, e.g. worn by the patient
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• 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 5/7275 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 5/742 using visual displays A61B5/339 takes precedence
• CPC Class Codes: G08C 17/02 using a radio link
• CPC Class Codes: G16H 15/00 ICT specially adapted for medical reports, e.g. generation or transmission thereof
• CPC Class Codes: G16H 20/10 relating to drugs or medications, e.g. for ensuring correct administration to patients
• CPC Class Codes: G16H 20/60 relating to nutrition control, e.g. diets
• CPC Class Codes: G16H 40/67 for remote operation
• CPC Class Codes: G16H 50/20 for computer-aided diagnosis, e.g. based on medical expert systems
• CPC Class Codes: G16H 50/30 for calculating health indices; for individual health risk assessment
• CPC Class Codes: G16Z 99/00 Subject matter not provided for in other main groups of this subclass
• CPC Class Codes: H04W 4/80 Services using short range communication, e.g. near-field communication [NFC], radio-frequency identification [RFID] or low energy communication
• CPC Class Codes: Y02A 90/10 Information and communication technologies [ICT] supporting adaptation to climate change, e.g. for weather forecasting or climate simulation

Abstract

Systems, devices and methods for managing a physiological condition are configured to store predetermined output segments of content, analyze physiological data and other user information, and generate user-friendly information that provides an interpretation of the data (e.g., identifies selected data points, or determines pattern of physiological data over selected period(s)). An output segment management system with rules engine and method combines selected output segments to generate a presentation or message (e.g., with text, graphical, multimedia, video and/or audio information). The resulting presentation or message provides user information such as an explanation of selected data with selected user information incorporated therein, and optional recommendations (e.g., suggested user actions based on a designated protocol such as a clinical protocol).

Claims

1. A method of generating physiological condition information comprising:

coupling to at least one physiological condition sensor to receive measured physiological data corresponding to a user therefrom;

storing the physiological data and user information in a memory device, the user information selected from the group consisting of physiological data thresholds, meal times, exercise times, age, weight, medication, amounts and times of medication administration, heart rate, body temperature, and food intake information;

analyzing, via a processing device comprising a rules engine, the physiological data to determine whether an event relating to the physiological data has occurred or will occur and for which the user is to be alerted, the event represented by event information that is selected for the user and that is determined via the processing device using a rules engine and a designated protocol for managing the physiological condition, the physiological data, and at least one of the user information, the event information comprising at least one of a selected data point and a selected pattern of the physiological data that indicates at least one of a rate of change in the physiological data that exceeds a designated threshold, a predicted value corresponding to the physiological data, and physiological data failing to meet designated parameters during a designated time period on each of a plurality of days; and

when the processing device determines the user is to be alerted of an event, generating, via the processing device, a presentation of physiological condition information that comprises a video, the video presenting an explanation of the event information that includes at least one of values selected from among the stored physiological data and the stored user information that contributed to the event information, and values derived from at least one of the stored physiological data and the stored user information that contributed to the event information.

2. A method as claimed in claim 1, further comprising storing a plurality of output segments in the memory device that are predetermined and stored independently of the received physiological data,

wherein the output segments are at least one of audio segments and video segments, and the generating comprises selecting and combining selected ones of the output segments to create the video.

3. A method as claimed in claim 1, wherein the presentation can comprise at least one of an audio output, a graphical output, an audiovisual output, and an alphanumeric output.

4. A method as claimed in claim 1, further comprising storing a plurality of output segments in the memory device that are predetermined and stored independently of the received physiological data, the stored output segments being at least one of audio, video and audiovisual, wherein generating comprises selecting and combining selected ones of the output segments to create the presentation.

5. A method as claimed in claim 4, wherein the output segments are recordings of user instructions for performing at least part of a physiological condition management action, and the analyzing comprises selecting one of a plurality of physiological condition management actions.

6. A method as claimed in claim 2, wherein the output segments are at least one of video recordings, audio recordings and graphical representations of a person or character presenting at least part of the presentation.

7. A method as claimed in claim 2, wherein the combining selected ones of the output segments comprises at least one of concatenating the selected ones of the output segments, overlaying the selected ones of the output segments, splicing the selected ones of the output segments into one another or into a separate stream, and outputting the selected ones of the output segments in respective positions in an output display screen.

8. A method as claimed in claim 2, wherein the generating comprises at least one of inserting the values among the combined output segments, simultaneously displaying the values in at least one of the combined segments, and combining the values with the combined output segments.

9. A method as claimed in claim 1 further comprising:

storing in a memory device a plurality of output segments that are predetermined and based on a designated protocol for managing the physiological condition, the stored output segments being at least one of audio, video, graphical, alphanumeric and audiovisual content;

wherein the generating comprises generating, via the processing device, a presentation of physiological condition information that is selected based on the designated protocol and comprises an explanation of the determined pattern or selected data point based on the designated protocol by combining selected ones of the output segments to create the presentation.

10. A method as claimed in claim 9, further comprising inserting values among the combined output segments, the values being at least one of values selected from among the stored physiological data and the stored user information that contributed to the determined pattern, and values derived from at least one of the stored physiological data and the stored user information that contributed to the determined pattern.

11. A method as claimed in claim 10, wherein the predetermined output segments are at least parts of instructions for user actions to perform at least part of the designated protocol for managing a physiological condition in a user having the determined pattern or selected data point.

16. A method as claimed in claim 1 wherein the physiological condition and the physiological data are related to glycemic control.

17. A method as claimed in claim 1 wherein the physiological data are measured subcutaneously or intravenously.

18. A method as claimed in claim 1, wherein receiving the physiological data comprises:

inductively coupling, via an inductive link, a sensor deployed in the user with an external user device;

powering the sensor via the inductive link; and

performing initial pairing of the sensor and the user device.

19. A method as claimed in claim 18, wherein performing initial pairing comprises exchanging security information.

20. A method as claimed in claim 18, wherein powering the sensor comprises using a quasi-static H field.

21. A method as claimed in claim 1, wherein the analyzing further comprises determining that an event will not occur based on the predicted value, and the presentation comprises a confirmation message indicating that the event will not occur.

22. A method as claimed in claim 1, wherein the analyzing comprises comparing the physiological data to a user computer calendar and determining a time period on the calendar during which an event is predicted to occur, and the presentation comprises a suggested user action to be taken during the time period to mitigate or avoid the effects of the event.

23. The method as claimed in claim 1, wherein the coupling to at least one sensor and receiving physiological data corresponding to a user therefrom comprises receiving streams of the physiological data wirelessly from the at least one sensor, and the analyzing, via the processing device, comprises analyzing the received streams of the physiological data.

24. The method as claimed in claim 23, wherein the coupling to at least one sensor and receiving physiological data corresponding to a user therefrom comprises receiving streams of the physiological data wirelessly from a plurality of sensors, and the analyzing, via the processing device, comprises analyzing the received streams of the physiological data.

25. A method as claimed in claim 1, wherein the storing comprises also storing at least one of environmental, stressor and trigger data in the memory device, and the video comprises suggestive recommendations to the user to manage the monitored physiological condition associated with the at least one of environmental, stressor and trigger data.

26. A method as claimed in claim 1, wherein the video comprises instructions for user actions to perform at least part of the designated protocol for managing the physiological condition in a user.

27. A method as claimed in claim 26, wherein the instructions are different according to an intended recipient operator of a user device.

12. An apparatus for generating physiological condition information comprising:

a communication link for coupling with at least one physiological condition sensor to receive measured physiological data corresponding to a user therefrom;

a memory device for storing

a plurality of output segments that are predetermined and based on a designated protocol for managing the physiological condition, the stored output segments being at least one of audio, video, graphical, alphanumeric and audiovisual content, and

physiological data and user information corresponding to a user, the user information selected from the group consisting of physiological data thresholds, meal times, exercise times, age, weight, medication, amounts and times of medication administration, heart rate, body temperature, and food intake information; and

a processing device connected to the memory device and configured to

analyze the physiological data to determine whether an event relating to the physiological data has occurred or will occur and for which the user is to be alerted, the event being represented by event information that is selected for the user and that is determined via the processing device using a rules engine based on the designated protocol, the physiological data, and at least one of the user information and protocol data for managing the physiological condition, the event information comprising at least one of a selected data point and a selected pattern of the physiological data that indicates at least one of a rate of change in the physiological data that exceeds a designated threshold, a predicted value corresponding to the physiological data, and physiological data failing to meet designated parameters during a designated time period on each of a plurality of days, and

when the processing device determines the user is to be alerted of an event, generate a presentation of physiological condition information that is selected based on the designated protocol and comprises an explanation of the event information by combining selected ones of the output segments and the selected event information to create the presentation.

13. An apparatus as claimed in claim 12, wherein the processing device is further configured to insert values among the combined output segments, the values being at least one of values selected from among the stored physiological data and the stored user information that contributed to the determined pattern, and values derived from at least one of the stored physiological data and the stored user information that contributed to the determined pattern.

14. An apparatus as claimed in claim 13, wherein the predetermined output segments are at least parts of instructions for performing at least part of the designated protocol for managing a physiological condition in a user having the determined pattern or selected data point.

15. An apparatus as claimed in claim 14, wherein the processing device, using the rules engine, determines the physiological condition information selected for the presentation based on the designated protocol.

28. An apparatus as claimed in claim 12, wherein memory device also stores at least one of environmental, stressor and trigger data in the memory device, and the output segments of the presentation comprises suggestive recommendations to the user to manage the monitored physiological condition associated with the at least one of environmental, stressor and trigger data.

29. An apparatus as claimed in claim 12, wherein the output segments of the presentation comprise instructions for user actions to perform at least part of the designated protocol for managing the physiological condition in a user.

30. An apparatus as claimed in claim 29, wherein the instructions are different according to an intended recipient operator of a user device.