Event detection using a variable threshold

• US 10,485,488 B2
• Filed: 06/23/2016
• Issued: 11/26/2019
• Est. Priority Date: 06/24/2015
• Status: Active Grant

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: Bhat, Maya, Averina, Viktoria A., Krueger, Jonathan Walter, Thakur, Pramodsingh Hirasingh
• Primary Examiner(s): Evanisko, George R
• Application Number:
  US15/190,511
• Publication Number:
  US 20170027527A1
• Time in Patent Office: 1,251 Days
• CPC Class Codes: A61B 5/02028 Determining haemodynamic parameters not otherwise provided for, e.g. cardiac contractility or left ventricular ejection fraction
• CPC Class Codes: A61B 5/1107 Measuring contraction of parts of the body, e.g. organ, muscle apparatus for measuring work or force in general G01L
• CPC Class Codes: A61B 5/29 for permanent or long-term implantation
• CPC Class Codes: A61B 5/4842 Monitoring progression or stage of a disease
• CPC Class Codes: A61B 5/6801 specially adapted to be attached to or worn on the body surface
• CPC Class Codes: A61B 5/7264 Classification of physiological signals or data, e.g. using neural networks, statistical classifiers, expert systems or fuzzy systems neural networks per se G06N3/00; expert systems per se G06N5/00
• 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 5/7282 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 5/742 using visual displays A61B5/339 takes precedence
• 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 5/746 Alarms related to a physiological condition, e.g. details of setting alarm thresholds or avoiding false alarms alarms per se G08B
• CPC Class Codes: A61B 7/04 Electric stethoscopes microphones, acoustic transducers therefor H04R
• CPC Class Codes: A61N 1/36585 controlled by two or more physical parameters
• CPC Class Codes: A61N 1/3987 characterised by the timing or triggering of the shock
• 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

Abstract

Devices and methods for detecting an event using a variable threshold. A patient monitoring system can receive physiologic information and compare the information to an onset threshold. When the onset threshold is exceeded, the system shifts to a reset threshold that is different than the onset threshold. When the reset threshold is crossed, the system shifts back to the onset threshold.

Claims

1. A method of operating a medical device system, the method comprising:

sensing physiological information of a subject using the medical device, the physiological information associated with heart failure of the subject;

determining a trend of the received physiological information; and

displaying one of an onset threshold indicative of onset of a physiological alert condition associated with heart failure or a reset threshold indicative of an end of the physiological alert condition according to a state of a medical device so that when the onset threshold is displayed the reset threshold is not displayed and vice versa, the method further comprising;

in a first state, comparing the determined trend to the onset threshold, and;

while the determined trend is below the onset threshold, displaying the onset threshold; and

when the determined trend exceeds the onset threshold, displaying the reset threshold and transitioning to a second state;

in the second state, comparing the determined trend to the reset threshold, and;

while the determined trend is above the reset threshold, displaying the determined trend and the reset threshold; and

when the determined trend falls below the reset threshold, displaying the onset threshold and transitioning to the first state.

2. The method of claim 1, wherein determining the trend of physiological information includes determining a first patient trend prior to a detection of the physiological alert condition using the onset threshold and a second patient trend after the detection using the onset threshold, and wherein the method further comprises presenting a visual representation of the first patient trend and second patient trend over time, and indicating that an onset threshold level is an active threshold by showing the onset level on the visual representation time-aligned with the first patient trend.

3. The method of claim 2, wherein indicating that an onset threshold level is the active threshold comprises representing the patient trend or the onset threshold level using one or more of a color, a line thickness, a line type, and not displaying the first patient trend when the onset threshold level is the active threshold.

4. The method of claim 2, further comprising presenting on the visual representation the reset threshold level as the active threshold and aligning the reset threshold level with the second patient trend on a time axis, and returning to indicating that the onset threshold value is the active threshold when the reset threshold is satisfied.

5. The method of claim 4, wherein indicating that a reset threshold level is the active threshold comprises shading or highlighting an area between the second trend and the reset threshold, an area between the onset threshold and the first trend, or an area above the reset threshold and above the onset threshold.

6. The method of claim 2, comprising displaying a visual representation of the first patient trend, second patient trend, onset threshold level, and reset threshold level, and displaying a difference between the onset threshold level and reset threshold level as a patient alert period that starts when the first patient trend exceeds the onset threshold level and ends when the second patient trend falls below the reset threshold level.

7. The method of claim 1, further comprising declaring an alert that a patient therapy regimen should be adjusted, and adjusting the patient therapy regimen in response to the alert.

8. The method of claim 1, further comprising receiving an onset input to adjust the onset threshold level and receiving a reset input to adjust the reset threshold level, wherein the monitoring of the patient is adjustably configurable using the onset input and the reset input.

9. The method of claim 1, further comprising receiving an threshold input to simultaneously adjust the onset threshold level and the reset threshold value, and receiving an offset input to adjust an offset between the onset threshold level and the reset threshold level, wherein the monitoring of the patient is adjustably configurable using the threshold input and the offset input.

10. A method of operating a medical device system, comprising:

sensing physiological information of a subject;

determining at least one physiologic parameter using the received physiological information;

determining a first trend of the at least one physiologic parameter using multiple samples of the received physiological information, the at least one physiologic parameter associated with heart failure;

displaying one of an onset threshold indicative of onset of a physiological alert condition associated with heart failure or a reset threshold indicative of an end of the physiological alert condition according to a state of the medical device so that when the onset threshold is displayed the reset threshold is not displayed and vice versa, the method further comprising;

in a first state, comparing the first trend to the onset threshold, and;

while the determined trend is below the onset threshold, displaying the onset threshold;

when the first trend exceeds the onset threshold, displaying the reset threshold and transitioning to a second state;

in the second state, determining a second trend of the at least one physiologic parameter using the samples detected after the first trend exceeds the onset threshold, comparing the second trend to a reset threshold that is lower than the onset threshold, and;

while the second determined trend is above the reset threshold, displaying the second determined trend and the reset threshold; and

when the determined second trend falls below the reset threshold, displaying the onset threshold and transitioning to the first state.

11. The method of claim 10, including determining two or more physiologic parameters using the multiple samples, and wherein determining a first trend comprises determining a trend of a composite index of the two or more physiologic parameters.

12. The method of claim 11, including varying the reset threshold as a function of which of the two or more physiologic parameters dominates a change in the composite index.

13. The method of claim 11, further comprising indicating the degree to which the two more physiologic parameters are responsible for a change in the composite index.

14. The method of claim 10, including varying the reset threshold as a function of time.

15. A patient monitoring system comprising:

a display;

a sense circuit configured to sense physiologic information of a subject, the physiological information associated with heart failure of the subject; and

a physiologic data analyzer circuit configured to;

receive the sensed physiological information of a subject, the physiological;

determine a trend of the received physiological information; and

display one of an onset threshold indicative of onset of a physiological alert condition associated with heart failure or a reset threshold indicative of an end of the physiological alert condition according to a state of the physiologic data analyzer circuit so that when the onset threshold is displayed the reset threshold is not displayed and vice versa, the displaying comprising;

in a first state, comparing the determined trend to an onset threshold indicative of onset of a physiological alert condition associated with heart failure, and;

while the determined trend is below the onset threshold, displaying the onset threshold; and

when the determined trend exceeds the onset threshold, displaying the reset threshold and transitioning to a second state;

in the second state, comparing the determined trend to the reset threshold, and;

while the determined trend is above the reset threshold, displaying the determined trend and the reset threshold; and

when the determined trend falls below the reset threshold, display the onset threshold and transitioning to the first state.

16. The patient monitoring system of claim 15, wherein the system includes an implantable or wearable device, the implantable or wearable device including the physiologic data analyzer circuit.

17. The patient monitoring system of claim 16, including a memory circuit, wherein the physiologic data analyzer circuit is configured to store a duration of a physiological alert condition in the memory circuit to be available for review by an external device such as a programmer.

18. The patient monitoring system of claim 15, wherein the physiologic data analyzer circuit is further configured to:

determine a dynamic threshold that varies based on time or a physiologic parameter determined using the physiological information; and

set one of the onset threshold and the reset threshold to the determined dynamic threshold.

19. The patient monitoring system of claim 15, wherein the patient monitoring system comprises an wearable device, and further comprising an external device communicatively coupled to the wearable device, wherein the wearable medical is configured to communicate a beginning and end of an alert period to the external device determined according to the comparing the determined trend to the onset threshold and the reset threshold.

20. The patient monitoring system of claim 19, wherein the external device comprises the display, and wherein the display is configured to show either the onset threshold or the reset threshold as the active threshold for comparing values of the determined trend.