Alert management for physiological event detection

• US 10,278,653 B2
• Filed: 03/29/2017
• Issued: 05/07/2019
• Est. Priority Date: 04/01/2016
• Status: Active Grant

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: Averina, Viktoria A., Thompson, Julie A., Thakur, Pramodsingh Hirasingh, An, Qi, Zhang, Yi
• Primary Examiner(s): Girma, Fekadeselassie
• Application Number:
  US15/473,190
• Publication Number:
  US 20170281099A1
• Time in Patent Office: 769 Days
• CPC Class Codes: A61B 2505/03 Intensive care
• CPC Class Codes: A61B 2505/07 Home care
• CPC Class Codes: A61B 5/0031 Implanted circuitry
• CPC Class Codes: A61B 5/283 Invasive
• CPC Class Codes: A61B 5/316 Modalities, i.e. specific diagnostic methods
• CPC Class Codes: A61B 5/686 Permanently implanted devices, e.g. pacemakers, other stimulators, biochips A61B5/6861 takes precedence
• 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 5/746 Alarms related to a physiological condition, e.g. details of setting alarm thresholds or avoiding false alarms alarms per se G08B
• CPC Class Codes: G08B 21/0453 worn on the body to detect health condition by physiological monitoring, e.g. electrocardiogram, temperature, breathing detecting, measuring or recording for diagnostic purposes A61B5/00
• CPC Class Codes: G08B 29/22 Provisions facilitating manual calibration, e.g. input or output provisions for testing; Holding of intermittent values to permit measurement
• CPC Class Codes: G16H 40/20 for the management or administration of healthcare resources or facilities, e.g. managing hospital staff or surgery rooms
• CPC Class Codes: G16H 50/30 for calculating health indices; for individual health risk assessment

Abstract

Systems, devices, and methods for managing alerts associated with a target physiological event such as a worsening heart failure event are described. A system may detect one or more alert onsets using an onset threshold, and one or more corresponding alert terminations using a reset threshold. Alerts may be issued corresponding to the detected alert onsets and alert terminations. The system may compare the alerts to a specified alert characteristic, and iteratively adjust the onset or reset threshold until the alerts corresponding to the adjusted onset or reset threshold satisfy the specified alert characteristic. The adjusted onset and reset thresholds may be presented to a user or a process for detecting the target physiological event.

Claims

1. A system for managing alerts associated with a target physiological event in a subject, the system comprising:

a physiological sensor circuit including a sense amplifier circuit to sense a physiological signal;

a signal processor circuit configured to generate a signal metric trend from the sensed physiological signal;

an alert management circuit coupled to the signal processor circuit, the alert management circuit including;

a comparator circuit to detect from the signal metric trend (1) one or more alert onsets using an onset threshold and (2) one or more corresponding alert terminations using a reset threshold;

an alert generator circuit to issue one or more alerts corresponding to the detected one or more alert onsets and one or more alert terminations, and to generate a reference alert characteristic, including an alert timing or an alert statistic, using timing information or a count of the previously issued one or more alerts; and

a parameter adjuster circuit to iteratively adjust the onset or reset threshold, including;

when the reference alert characteristic of the one or more alerts fails to satisfy a specified alert characteristic, adjust the onset or reset threshold until the reference alert characteristic of the one or more alerts corresponding to the adjusted onset or reset threshold satisfies the specified alert characteristic; and

when the reference alert characteristic of the one or more alerts satisfies the specified alert characteristic, determine target onset and reset thresholds for presenting to a user or a process, and

a user interface for generating a human-perceptible presentation of the one or more alerts.

2. The system of claim 1, further comprising a detector circuit configured to detect a heart failure event based on the one or more alert onsets and the corresponding one or more alert terminations.

3. The system of claim 1, wherein the human-perceptible presentation of the one or more alerts include:

an alert number during a specified period of time;

an alert duration;

an indication of true alert or false alert;

or

a count of true or false alerts.

4. The system of claim 1, wherein the user interface is configured to receive user input including the specified alert characteristic.

5. The system of claim 1, wherein the parameter adjuster circuit is configured to adjust at least one of the onset or reset threshold according to a step-up or a step-down protocol.

6. The system of claim 1, wherein the specified alert characteristic includes one or more of:

an alert number during a specified time period;

an alert duration;

an inter-alert interval;

a false alert number;

a true alert number;

a temporal pattern of alerts;

a statistical distribution of alerts during a specified time period;

a statistical distribution of alert durations;

a statistical distribution of false alert number or true alert number;

or

a statistical distribution of inter-alert intervals.

7. The system of claim 1, wherein the specified alert characteristic includes an expected number of alerts during a specified time period, and the alert generator circuit issues a reference number of alerts corresponding to the detected alert onsets and alert terminations within the specified time period, and wherein the parameter adjuster circuit is configured to:

if the expected alert number is less than the reference alert number, increase at least the onset threshold until the alert generator circuit issues the expected number of alerts;

or

if the expected alert number is greater than the reference alert number, decrease at least the onset threshold until the alert generator circuit issues the expected number of alerts.

8. The system of claim 1, wherein the specified alert characteristic includes an expected false alert number during a specified time period, and the alert generator circuit issues a reference false alert number within the specified time period, and wherein the parameter adjuster circuit is configured to, if the expected false alert number is less than the reference false alert number, increase at least the onset threshold until the alert generator circuit issues expected false alert number.

9. The system of claim 1, wherein the specified alert characteristic includes an expected true alert number during a specified time period, and the alert generator circuit issues a reference true alert number within the specified time period, and wherein the parameter adjuster circuit is configured to, if the expected true alert number is greater than the reference true alert number, decrease at least the onset threshold until the alert generator circuit issues expected true alert number.

10. The system of claim 1, wherein the parameter adjuster circuit is configured to:

receive information about a known clinical event during a specified time period;

adjust at least the onset threshold until the alert generator circuit issues at least one alert temporally corresponding to the known clinical event; and

determine the target onset threshold as the adjusted threshold corresponding to the known clinical event.

11. The system of claim 1, wherein the parameter adjuster circuit is configured to:

receive information about a known stable period;

adjust at least the onset threshold until the alert generator circuit issues no more than a specified acceptable number of alerts within the known stable period; and

determine the target onset threshold as the adjusted threshold corresponding to the specified acceptable number of alerts.

12. The system of claim 11, wherein the specified acceptable number of alerts within the known stable period is zero, and the parameter adjuster circuit is configured to determine the target onset threshold as the smallest threshold corresponding to no alert during the stable period.

13. The system of claim 1, wherein the parameter adjuster circuit is configured to:

receive information about a known unstable period including onset timing of the known unstable period;

adjust at least the onset threshold until the alert generator circuit generates an alert substantially close to the onset timing of the known unstable period; and

determine the target onset threshold as the smallest threshold corresponding to the alert substantially close to the onset timing of the known unstable period.

14. The system of claim 1, wherein the parameter adjuster circuit is configured to receive information about a medical history of the subject, and to determine the target onset or reset threshold based on the subject'"'"'s medical history.

15. The system of claim 14, wherein the parameter adjuster circuit is configured to determine the specified alert characteristic including an indication-based characteristic based on an association between the subject'"'"'s medical history and expected alert characteristic;

and

determine the target onset or reset threshold using the indication-based alert characteristic.

16. A method for managing alerts associated with a target physiological event in a subject via an alert management system, the method comprising:

sensing a physiological signal;

generating a signal metric trend from the sensed physiological signal;

detecting from the signal metric trend (1) one or more alert onsets using an onset threshold and (2) one or more corresponding alert terminations using a reset threshold;

issuing one or more alerts corresponding to the detected one or more alert onsets and one or more alert terminations;

generating a reference alert characteristic;

including an alert timing or an alert statistic, using timing information or a count of the previously one or more alerts; and

iteratively adjusting the onset or reset threshold via the alert management system, the iterative adjustment including;

when the reference alert characteristic of the one or more alerts fails to satisfy a specified alert characteristic;

adjusting the onset or reset threshold until the reference alert characteristic of the one or more alerts corresponding to the adjusted onset or reset threshold satisfies the specified alert characteristic; and

when the reference alert characteristic of the one or more alerts satisfies the specified alert characteristic, determining target onset and reset thresholds for presenting to a user or a process; and

generating a human-perceptible presentation of the one or more alerts.

17. The method of claim 16, further comprising receiving information about a known clinical event during a specified time period, wherein the iterative adjustment of the onset or reset threshold includes:

adjusting at least the onset threshold until at least one alert temporally corresponding to the known clinical event is issued; and

determining the target onset threshold as the adjusted threshold corresponding to the known clinical event.

18. The method of claim 16, further comprising receiving information about a known stable period, wherein the iterative adjustment of the onset or reset threshold includes:

adjusting at least the onset threshold until no more than a specified acceptable number of alerts is issued within the known stable period; and

determining the target onset threshold as the adjusted threshold corresponding to the specified acceptable number of alerts.

19. The method of claim 16, further comprising receiving information about a known unstable period including onset timing of the known unstable period, wherein the iterative adjustment of the onset or reset threshold includes:

adjusting at least the onset threshold until an alert substantially close to the onset timing of the known unstable period is issued; and

determining the target onset threshold as the smallest threshold corresponding to the alert substantially close to the onset timing of the known unstable period.

20. The method of claim 16, further comprising receiving information about a medical history of the subject, wherein the iterative adjustment of the onset or reset threshold includes:

determining the specified alert characteristic including an indication-based alert characteristic based on an association between the subject'"'"'s medical history and expected alert characteristic; and

determining the target onset or reset threshold using the indication-based alert characteristic.