A system and method for monitoring compliance with the use of portable medical devices in patients.

Abstract

[0003] Devices, systems, and methods for providing patient wear compliance information are provided. For example, a medical device includes a plurality of electrodes continuously coupled externally to a patient and configured to monitor electrical activity on the patient's skin. The system also includes at least one motion sensor configured to generate a movement signal based on the patient's movement. The system further includes a processor configured to receive an electrical signal based on the monitored electrical activity, record a wear start event based on the electrical signal and the movement signal, record a wear end event based on one or more of the electrical signal and the movement signal indicating that the patient is not wearing the medical device, and output a graphical representation including information about the patient's wear compliance based on the recorded wear start event and the recorded wear end event.

Description

Technical Field

[0001] This application claims priority under 35 U.S.C. § 120 to U.S. Patent Application No. 16 / 951,246, filed November 18, 2020, entitled "Systems and Methods for Monitoring Patient Compliance with a Wearable Medical Device." The U.S. Patent Application is hereby incorporated by reference in its entirety.

Background Art

[0002] The present disclosure relates to monitoring patients prescribed a wearable medical device for compliance.

[0003] Heart failure, if left untreated, can lead to certain life-threatening arrhythmias. Both atrial and ventricular arrhythmias are common in patients with heart failure. One of the most lethal arrhythmias is ventricular fibrillation, which occurs when normal and regular electrical impulses are replaced by irregular and rapid impulses, causing the myocardium to stop normal contractions. Patients often do not receive a perceptible warning that fibrillation is imminent and may die before the necessary medical support arrives. Other arrhythmias can include an overly slow heart rate known as bradycardia or an overly fast heart rate known as tachycardia. Cardiac arrest can occur when the levels of blood flow that the heart provides to the brain and other vital organs to support life become insufficient due to various arrhythmias of the heart, such as ventricular fibrillation, ventricular tachycardia, pulseless electrical activity (PEA), and asystole (where the heart stops all electrical activity). Monitoring heart failure patients is generally useful to early evaluate signs of heart failure and provide intervention therapy as soon as possible.

[0004] Patients who are at risk, have been hospitalized due to a harmful cardiac condition, or otherwise suffer from such a condition may be prescribed a wearable cardiac monitoring and / or therapeutic device. In addition to the wearable device, the patient may also be given a battery charger and a set of rechargeable batteries. Since wearable devices are generally prescribed for continuous or near-continuous use (e.g., removed only when bathing), the patient wears the device during all daily activities, such as walking, sitting, climbing stairs, resting, or sleeping, and other similar daily activities. Maintaining continuous use of the prescribed device can promote better reliability of data collected from monitoring the patient's progress and ensure better protection of the patient, including the provision of treatment when necessary. [Overview of the project]

[0005] In at least one example, a wearable defibrillator is provided for providing patient-wearing compliance information. The wearable defibrillator comprises: a plurality of electrodes configured to be continuously coupled to a patient from an external source over an extended period of time, and configured to monitor electrical activity on the patient's skin and to deliver a therapeutic shock to the patient in response to the detection of cardiac arrhythmias based on the monitored electrical activity; at least one motion sensor and associated circuitry configured to generate at least one motion signal based on the patient's movement; and at least one processor operably coupled to the plurality of electrodes and the at least one motion sensor and associated circuitry. The at least one processor is configured to receive at least one electrical signal based on the monitored electrical activity on the patient's skin from the plurality of electrodes; record an on-wear event based on the at least one electrical signal and the at least one motion signal indicating that the patient is wearing the wearable defibrillator; record an on-wear event based on one or more of the at least one electrical signal and the at least one motion signal indicating that the patient is not wearing the wearable defibrillator; and output a graphic representation including information about the patient's on-wear compliance based on the recorded on-wear event and the recorded on-wear event.

[0006] The implementation of a wearable defibrillator may include one or more of the following features:

[0007] In an example, the wearable defibrillator may further comprise a display operably coupled to the at least one processor, the at least one processor configured to provide, via the display, a graphical representation of the patient's wear compliance based on output information relating to the patient's wear compliance.

[0008] In an example, the wearable defibrillator may further include a network interface operably coupled to the at least one processor, the at least one processor configured to transmit the information relating to the patient's wearing compliance to a remote server.

[0009] In the example of the wearable defibrillator, the at least one processor may further be configured to detect an electrocardiogram (ECG) signal based on the at least one electrical signal, and to control the wearable defibrillator to provide the patient with an ECG signal therapeutic shock in response to the detection of the cardiac arrhythmia based on the detected ECG signal.

[0010] In the example of the wearable defibrillator, recording the initiation event includes detecting one or more ECG signals based on the at least one electrical signal, determining whether the one or more ECG signals meet one or more effectiveness criteria, and recording the initiation event if the one or more ECG signals meet at least one of the one or more effectiveness criteria. In some examples, the one or more effectiveness criteria include at least one ECG parameter derived from the one or more ECG signals that meet the effectiveness threshold. In some examples, the at least one ECG parameter includes an R-peak amplitude, and meeting the effectiveness threshold includes identifying at least five consecutive R-peak amplitudes, each exceeding an amplitude threshold. In some examples, the at least one ECG parameter includes a QRS complex width, and meeting the effectiveness threshold includes measuring at least five consecutive QRS complex widths, each between 0.05 seconds and 0.15 seconds. In some examples, the at least one processor may be further configured to determine the patient's fit compliance based on a first ECG signal among the one or more ECG signals that satisfy the validity threshold.

[0011] In the example of the wearable defibrillator, recording the start-up event may include detecting the skin-sensor interface impedance level based on the at least one electrical signal from one or more of the plurality of electrodes, determining whether the impedance level is within an acceptable impedance range, and recording the start-up event if the impedance level is within the acceptable impedance range; and recording the end-up event may include determining whether the impedance level is no longer within the acceptable impedance range, and recording the end-up event based on the determination that the impedance level is no longer within the acceptable impedance range. In some examples, the acceptable impedance range includes at least one of the ranges from 20 ohms to 250 ohms, from 250 ohms to 1 kilohm, and from 1 kilohm to 20 kilohms.

[0012] In the example of the wearable defibrillator, recording the on-wear event may include determining whether the motion signal indicates movement of the patient and the wearable defibrillator, and if the motion signal indicates movement of the patient and the wearable defibrillator, recording the on-wear event.

[0013] In some examples, the at least one processor may be configured to detect one or more ECG signals based on the at least one electrical signal if the motion signal does not indicate movement of the patient and the wearable defibrillator, and to record the wear-in event based on an analysis of the one or more ECG signals. In some examples, the at least one processor may be configured to detect one or more noise components in the at least one electrical signal, and to confirm that there is no movement of the patient based on an analysis of the one or more noise components in the at least one electrical signal.

[0014] In the example of the wearable defibrillator, recording the on-wear event may include receiving input from the patient indicating that the patient is wearing the wearable defibrillator, and recording the on-wear event based on the input from the patient. In some examples, recording the wear-initiation event based on the input from the patient includes confirming that the patient is wearing the wearable defibrillator based on the at least one electrical signal and the at least one motion signal, and recording the wear-initiation event.

[0015] In the example of the wearable defibrillator, recording the end-of-use event may include detecting a change in the at least one electrical signal indicating an invalid ECG signal, and recording the end-of-use event based on the invalid ECG signal.

[0016] In the example of the wearable defibrillator, recording the end-of-wearing event may include detecting a change in the skin-sensor interface impedance level at one or more of the multiple electrodes, determining whether the impedance level exceeds an impedance threshold, and, if the impedance level exceeds the impedance threshold, recording the end-of-wearing event. In some examples, the impedance threshold may include one or more of 10 kilohms, 100 kilohms, 1 megahm, 2 megahms, 5 megahms, and 10 megahms.

[0017] In the example of the wearable defibrillator, recording the end-of-wearing event may include determining that one or more of the plurality of electrodes and at least one motion sensor and associated circuitry have been disconnected from the wearable defibrillator, and recording the end-of-wearing event once it is determined that one or more of the plurality of electrodes and at least one motion sensor and associated circuitry have been disconnected.

[0018] In the example of the wearable defibrillator, recording the end-of-wear event may include detecting that the patient has removed the wearable defibrillator based on an analysis of the at least one motion signal, confirming that the at least one electrical signal indicates that the patient has removed the wearable defibrillator, and recording the end-of-wear event based on the confirmation that the patient has removed the wearable defibrillator.

[0019] In the example of the wearable defibrillator, recording the end-of-use event may include receiving input from the patient indicating that the patient has removed the wearable defibrillator, and recording the end-of-use event based on the input from the patient. In some examples, recording the end-of-wearing event based on the input from the patient includes confirming that the patient has removed the wearable defibrillator based on the at least one electrical signal and the at least one motion signal, and recording the end-of-wearing event.

[0020] In the example of the wearable defibrillator, the at least one processor may be configured to determine the current time and to record at least one of the wear-in start event and the wear-out end event based on one or more of the at least one motion signal, the at least one electrical signal, and the current time. In some examples, determining the current time includes determining, based on the current time, whether the patient has been active or inactive. In some examples, the at least one processor may be configured to record at least one of the insertion start event and the insertion end event based on the at least one electrical signal if the patient has been inactive at the current time. In some examples, the at least one processor may be configured to record at least one of the insertion start event and the insertion end event based on the at least one electrical signal and the at least one motion signal if the patient has been active at the current time. In some examples, the at least one processor may be configured to determine, based on the current time and past patient activity information recorded by the wearable defibrillator, whether the patient has been active or inactive.

[0021] In the example of the wearable defibrillator, the graphic representation may include an indication of patient compliance with patient non-compliance.

[0022] In the example of the wearable defibrillator, the graphic representation may include an indication of recorded changes in the patient's compliance with wearing the device.

[0023] In the example of the wearable defibrillator, the graphic representation may include a timeline showing the recorded start and end events of wearing the device. In some examples, the timeline further shows the total time the wearable defibrillator was worn by the patient and the total time the wearable defibrillator was not worn by the patient over a user-selectable period.

[0024] In the example of the wearable defibrillator, the graphic representation may include one or more user-selectable interface controls configured to provide access to recorded ECG information for one or more of the following: the start event of wearing the device, the end event of wearing the device, and the period during which the patient wore the wearable defibrillator.

[0025] In an example of the wearable defibrillator, the at least one processor may further be configured to output a notification of the patient's wear compliance. In some examples, outputting the notification of the patient's wear compliance includes comparing the patient's wear compliance to one or more notification criteria and outputting the notification if the patient's wear compliance meets at least one of the one or more notification criteria. In some examples, the one or more notification criteria may include the patient failing to wear the wearable defibrillator for a particular percentage of a period of time. In some examples, the one or more notification criteria may include a recorded change in the patient's wear compliance that exceeds a compliance change threshold. In some examples, the at least one processor may further be configured to output the notification of the patient's wear compliance to at least one of the patient, a care provider associated with the patient, and a prescriber of the wearable defibrillator.

[0026] In another example, a method of providing wear compliance information recorded by a wearable defibrillator worn by a patient is provided. The method includes at least one processor obtaining at least one electrical signal determined based on monitored electrical activity on the patient's skin. One processorSteps include: receiving from multiple electrodes operably coupled to the at least one processor; receiving at least one motion signal based on the patient's movement and generated by at least one motion sensor and associated circuitry operably coupled to the at least one processor; recording an on-wear event based on one or more of the at least one electrical signal and the at least one motion signal indicating that the patient is wearing the wearable defibrillator; recording an on-wear event based on one or more of the at least one electrical signal and the at least one motion signal indicating that the patient is not wearing the wearable defibrillator; and the at least one processor recording an on-wear end event based on one or more of the at least one electrical signal and the at least one motion signal indicating that the patient is not wearing the wearable defibrillator. The at least one processor provides a graphical representation of the patient's wearing compliance based on recorded wearing start and wearing end events; the at least one processor receives one or more notification criteria from one or more of the patient's caregivers and the wearable defibrillator prescribers; the at least one processor compares the patient's wearing compliance with the one or more notification criteria; and if the patient's wearing compliance meets at least one of the one or more notification criteria, the at least one processor outputs a notification to one or more of the patient, the patient's caregivers and the wearable defibrillator prescribers.

[0027] An implementation of a method for providing wear compliance information recorded by a wearable defibrillator worn by a patient may include one or more of the following features:

[0028] In some examples of the method, the method may further include the step of the at least one processor outputting a graphical representation of the patient's fit compliance, based on output information relating to the patient's fit compliance, to a display operably coupled to the at least one processor.

[0029] In some examples of the method, the method may further comprise the at least one processor transmitting the information regarding the patient's wearing compliance to a remote server operatively coupled to the at least one processor via a network interface.

[0030] In some examples of the method, the method may further comprise the at least one processor detecting an ECG signal based on the at least one electrical signal, and the at least one processor controlling the wearable defibrillator to provide a therapeutic shock to the patient in response to the detection of an arrhythmia based on the detected ECG signal.

[0031] In the method described above, the step of recording the fitting start event may include the step of the at least one processor detecting one or more ECG signals based on the at least one electrical signal; the step of the at least one processor determining whether the one or more ECG signals satisfy one or more validity criteria; and if the one or more ECG signals satisfy at least one of the one or more validity criteria, the at least one processor recording the fitting start event; and the step of recording the fitting end event may include the step of the at least one processor determining whether the impedance level is no longer within the acceptable impedance range; and the step of the at least one processor recording the fitting end event based on the determination that the impedance level is no longer within the acceptable impedance range. In some examples, the one or more validity criteria include at least one ECG parameter derived from the one or more ECG signals that satisfy the validity threshold. In some examples, the at least one ECG parameter may include an R peak amplitude, and satisfying the validity threshold may include identifying at least five consecutive R peak amplitudes, each exceeding an amplitude threshold. In some examples, the at least one ECG parameter may include a QRS complex width, and satisfying the validity threshold may include measuring at least five consecutive QRS complex widths, each between 0.05 seconds and 0.15 seconds. In some examples, the method further comprises the step of the at least one processor determining the patient's fit compliance based on a first ECG signal of the one or more ECG signals that satisfy the validity threshold.

[0032] In the method described above, recording the attachment initiation event may include detecting the skin-sensor interface impedance level in one or more of the plurality of electrodes, determining whether the impedance level is within an acceptable impedance range, and, if the impedance level is within the acceptable impedance range, recording the attachment initiation event. In some examples, the acceptable impedance range may include at least one of the ranges from 20 ohms to 250 ohms, from 250 ohms to 1 kilohm, and from 1 kilohm to 20 kilohms.

[0033] In the method described above, the step of recording the wear-initiation event may include the step of the at least one processor determining whether the motion signal indicates movement of the patient and the wearable defibrillator, and if the motion signal indicates movement of the patient and the wearable defibrillator, the at least one processor recording the wear-initiation event. In some examples, the method may further include the step of the at least one processor detecting one or more ECG signals based on the at least one electrical signal if the motion signal does not indicate movement of the patient and the wearable defibrillator, and the at least one processor recording the wear-initiation event based on an analysis of the one or more ECG signals. In some examples, the method may further include the step of the at least one processor detecting one or more noise components in the at least one electrical signal, and the at least one processor confirming that there is no movement of the patient based on an analysis of the one or more noise components in the at least one electrical signal.

[0034] In the above method, the step of recording the wear-initiation event may include the step of the at least one processor receiving input from the patient indicating that the patient is wearing the wearable defibrillator, and the step of the at least one processor recording the wear-initiation event based on the input from the patient. In some examples, the step of recording the wear-in event based on the input from the patient is the step of the at least one processor confirming that the patient is wearing the wearable defibrillator based on the at least one electrical signal and the at least one motion signal, and The step may include at least one processor recording the installation start event.

[0035] In the above method, the step of recording the installation completion event may include the step of the at least one processor detecting a change in the at least one electrical signal indicating an invalid ECG signal, and the step of the at least one processor recording the installation completion event based on the invalid ECG signal.

[0036] In the method described above, the step of recording the attachment completion event may include the step of the at least one processor detecting a change in the skin-sensor interface impedance level in one or more of the plurality of electrodes; the step of the at least one processor determining whether the impedance level exceeds an impedance threshold; and, if the impedance level exceeds the impedance threshold, the at least one processor recording the attachment completion event. In some examples, the impedance threshold may include one or more of 10 kilohms, 100 kilohms, 1 megahm, 2 megahms, 5 megahms, and 10 megahms.

[0037] In the above method, the step of recording the attachment completion event may include the step of the at least one processor determining that one or more of the plurality of electrodes and the at least one motion sensor and associated circuit are disconnected from the wearable defibrillator, and if it is determined that one or more of the plurality of electrodes and the at least one motion sensor and associated circuit are disconnected, the at least one processor recording the attachment completion event.

[0038] In the method described above, the step of recording the end-of-wearing event may include the step of the at least one processor detecting, based on an analysis of the at least one motion signal, that the patient has removed the wearable defibrillator; the step of the at least one processor confirming that the at least one electrical signal indicates that the patient has removed the wearable defibrillator; and the step of the at least one processor recording the end-of-wearing event based on the confirmation that the patient has removed the wearable defibrillator.

[0039] In the above method, the step of recording the end-of-wearing event may include the step of the at least one processor receiving input from the patient indicating that the patient has removed the wearable defibrillator, and the step of the at least one processor recording the end-of-wearing event based on the input from the patient. In some examples, the step of recording the end-of-wearing event based on the input from the patient may include the step of the at least one processor confirming that the patient has removed the wearable defibrillator based on the at least one electrical signal and the at least one motion signal, and the step of the at least one processor recording the end-of-wearing event.

[0040] In some examples of the method, the method may further comprise the steps of the at least one processor determining the current time, and the at least one processor recording at least one of the mounting start event and the mounting end event based on one or more of the at least one motion signal, the at least one electrical signal, and the current time. In some examples, the step of determining the current time may include a step in which the at least one processor determines, based on the current time, whether the patient has been active or inactive. In some examples, the method may further include a step in which, if the patient has been inactive at the current time, the at least one processor records at least one of the insertion start event and the insertion end event based on the at least one electrical signal. In some examples, the method may further include a step in which, if the patient has been active at the current time, the at least one processor records at least one of the insertion start event and the insertion end event based on the at least one electrical signal and the at least one motion signal. In some examples, the method may further include a step in which the at least one processor determines, based on the current time and past patient activity information recorded by the wearable defibrillator, whether the patient has been active or inactive.

[0041] In the method described above, the notification may include an indication of patient compliance for patient non-compliance with the device.

[0042] In the method described above, the notification may include an indication of recorded changes in the patient's compliance with the fitting.

[0043] In the method described above, the notification may include a timeline showing the recorded start and end events of the device. In some examples, the timeline may further show the total time the wearable defibrillator was worn by the patient and the total time the wearable defibrillator was not worn by the patient over a user-selectable period.

[0044] In the method described above, the notification may include one or more user-selectable interface controls configured to provide access to recorded ECG information for one or more of the following: a wear start event, a wear end event, and the period during which the patient wore the wearable defibrillator.

[0045] In the method described above, the step of outputting the notification of the patient's wearability compliance may include the step of the at least one processor comparing the patient's wearability compliance with one or more notification criteria; and the step of the at least one processor outputting the notification if the patient's wearability compliance satisfies at least one of the one or more notification criteria. In some examples, the one or more notification criteria may include the patient failing to wear the wearable defibrillator for a certain percentage of a period of time. In some examples, the one or more notification criteria may include a recorded change in the patient's wearability compliance that exceeds a compliance change threshold.

[0046] In at least one example, a patient monitoring device is provided for providing patient-wearing compliance, such as a wearable defibrillator. The wearable defibrillator comprises: a plurality of electrodes configured to be coupled externally to a patient over a period of time, and configured to monitor electrical activity on the patient's skin and / or to deliver a therapeutic shock to the patient in response to the detection of cardiac arrhythmias based on the monitored electrical activity; at least one motion sensor and associated circuitry configured to generate at least one motion signal based on the patient's movement; and at least one processor operably coupled to the plurality of electrodes and the at least one motion sensor and associated circuitry. The at least one processor is configured to receive at least one electrical signal based on the monitored electrical activity on the patient's skin from the plurality of electrodes, and to record one or both of a wear-in start event and a wear-out end event, wherein the wear-in start event may be based on the at least one electrical signal and the at least one motion signal indicating that the patient is wearing the wearable defibrillator, and the wear-out end event may be based on one or more of the at least one electrical signal and the at least one motion signal indicating that the patient is not wearing the wearable defibrillator, and one or both of the wear-in start event and the wear-out end event are recorded to determine the patient's wear compliance with the wearable defibrillator. [Brief explanation of the drawing]

[0047] Various aspects of at least one example are described below with reference to the accompanying drawings. These drawings are not intended to be depicted to actual size. The drawings are included to provide an explanation and further understanding of the various aspects and examples, and are incorporated into and form part of this specification, but are not intended to limit the scope of this disclosure. Together with the rest of this specification, the drawings help to illustrate the principles and operations of the described and claimed aspects and examples. In the drawings, each component that is identical or substantially identical shown in the various drawings is represented by the same reference numerals. For clarity, not all components may be labeled in all drawings.

[0048] [Figure 1A] An example of sample sensor placement for a patient, as described in this disclosure, is shown. [Figure 1B] An example of sensor placement for a patient, as described in this disclosure, is shown.

[0049] [Figure 2] The output of a sample accelerometer according to an example of this disclosure is shown.

[0050] [Figure 3] A schematic diagram of a sample controller for a wearable medical device, as an example of this disclosure, is shown.

[0051] [Figure 4] An example of this disclosure is shown: a sample controller configured to monitor patient compliance with wearing the device.

[0052] [Figure 5] This disclosure provides an example of a sample process flow for monitoring patient compliance with fitting procedures.

[0053] [Figure 6A] This disclosure provides an example of a sample process flow for monitoring and confirming a start event.

[0054] [Figure 6B] An example of this disclosure shows a sample process flow for monitoring and confirming an onset event by identifying changes in one or more physiological signals.

[0055] [Figure 6C] An example of this disclosure shows a sample process flow for monitoring and confirming an initiation event by identifying changes in one or more motion signals.

[0056] [Figure 6D] An example of this disclosure shows a sample process flow for monitoring and confirming an onset event by identifying changes in impedance at one or more electrodes.

[0057] [Figure 7A] This disclosure provides an example of a sample process flow for monitoring and confirming termination events.

[0058] [Figure 7B] This disclosure provides an example of a sample process flow for monitoring and confirming events based on time.

[0059] [Figure 8] An example of a sample network outlined in this disclosure is shown below.

[0060] [Figure 9] This disclosure includes a sample diagram of a user interface that allows a physician to access and modify compliance monitoring settings.

[0061] [Figure 10A] An example of a user interface, including graphical feedback related to patient fitting compliance information, is shown in this disclosure. [Figure 10B]An example of a user interface, including graphical feedback related to patient fitting compliance information, is shown in this disclosure. [Figure 10C] An example of a user interface, including graphical feedback related to patient fitting compliance information, is shown in this disclosure. [Figure 10D] An example of a user interface, including graphical feedback related to patient fitting compliance information, is shown in this disclosure. [Figure 10E] An example of a user interface, including graphical feedback related to patient fitting compliance information, is shown in this disclosure. [Figure 10F] An example of a user interface, including graphical feedback related to patient fitting compliance information, is shown in this disclosure.

[0062] [Figure 11A] An example of a portable medical device that may be prescribed to a patient with heart failure is shown in this disclosure. [Figure 11B] An example of a portable medical device that may be prescribed to a patient with heart failure is shown in this disclosure. [Figure 11C] An example of a portable medical device that may be prescribed to a patient with heart failure is shown in this disclosure. [Figure 11D] An example of a portable medical device that may be prescribed to a patient with heart failure is shown in this disclosure.

[0063] [Figure 12] An example of this disclosure is shown in the sample timing diagram illustrating the patient wearing period and corresponding start and end events.

[0064] [Figure 13] This disclosure provides an example of a sample input / output diagram of a compliance monitoring process. [Modes for carrying out the invention]

[0065] Wearable medical devices, such as cardiac event monitoring and / or therapeutic devices, are used in clinical or outpatient settings to monitor and / or record various ECGs and other physiological signals of a patient. These ECGs and other physiological signals may be used to monitor arrhythmias, and the exemplary devices described herein may provide treatment, such as defibrillation or pacing shock in cases of life-threatening arrhythmias. Exemplary cardiac monitoring and therapeutic devices capable of implementing the wear-compliance functions and / or processes described herein include wearable defibrillators, also known as wearable electrical defibrillators (WCDs). Another exemplary cardiac monitoring and therapeutic device capable of implementing the wear-compliance functions and / or processes described herein includes hospital-based wearable defibrillators (HWDs).

[0066] To effectively monitor the patient and, when necessary, provide treatment, it is desirable for the patient to wear the device as continuously as possible. For this purpose, patient monitoring compliance information can provide feedback to both the patient's physician and the patient themselves. Adjusting patient habits regarding medical device wear increases both the overall effectiveness of cardiac monitoring for the patient and the likelihood of providing treatment when necessary.

[0067] This disclosure relates to an improved wear time monitoring technique for providing patients and / or care providers with reliable patient compliance information, including wear start and end times, to determine overall patient wear compliance information. In the implementations described herein, wear compliance is determined using one or more electrical signals from the patient, from which ECG information and / or body impedance measurements can be derived. One or more electrical signals may be analyzed alone or in combination with patient motion information and / or one or more additional physiological signals to more precisely determine wear compliance.

[0068] For example, a processor in a wearable medical device as described herein may be configured to monitor a wear compliance initiation event indicating that a patient is wearing the medical device. Following the determination of the initiation event, the processor may further monitor an termination event indicating that the patient is no longer wearing the medical device. The time between the initiation event and the corresponding termination event may be recorded and analyzed to determine overall wear compliance information for the patient over a period of time, such as a day, a week, two weeks, a month, and other periods as described herein. In the examples described herein, wear compliance initiation and termination events may be based on physiological signals and other information, including, for example, ECG signals, body impedance measurements, patient motion information, time information, and / or other physiological signals and collected / observed information. With respect to physiological signals, including ECG signals, the systems and methods described herein evaluate such signals to determine that such signals originate from wear by the patient, for example, that the underlying physiological and / or ECG sensor is in contact with the patient's skin.

[0069] In the example, the processor may be configured to monitor physiological signals collected by sensors associated with the medical device to determine an initiation event, such as ECG signals and body impedance measurements, cardiac oscillation signals, and / or radio frequency (RF)-based physiological signals. Rather than relying solely on whether the medical device is on or off, or solely on patient movement information, at least some implementations herein use several combinations of medical device on / off status, patient movement information, ECG signals, body impedance measurements, cardiac oscillation signals, and / or RF-based physiological information. Each of these may be appropriately weighted in a predetermined manner. For example, an initiation event may be based on a combination in which the ECG signal is weighted more than the patient movement information (60% ECG signal and 40% patient movement information). For example, the processor may monitor physiological signals received from physiological sensors and combine the physiological signals with motion signals received from motion sensors to identify changes that may indicate an initiation event. Once an initiation event is detected, the processor may continue monitoring signals for changes that may indicate an termination event. Once a termination event is detected, the processor may process or otherwise generate information related to the patient's wear compliance for display to, for example, the patient's physician or healthcare provider (HCP), the patient, or another person associated with the provision of treatment for the patient.

[0070] The fit compliance monitoring described herein offers various advantages and benefits. In some examples described herein, by monitoring one or more types of physiological signals derived from the patient (e.g., ECG signals, cardiac oscillation signals, RF-based signals, and / or bioimpedance signals) alone or in combination with other signals such as patient motion information about start and end events, the processor can accurately obtain fit compliance information indicating that the patient is actually wearing the medical device. Signals such as ECG signals, cardiac oscillation signals, bioimpedance signals, and RF-based signals are received directly from the patient wearing the medical device. If the patient is not wearing the medical device, such signals would not be available. For example, in one scenario, the implementation described herein uses both ECG signal information and patient motion information to determine fit compliance. Systems using patient motion information can be enhanced and made more reliable by implementing the functions described herein. As a result, the implementation described herein is less prone to errors in determining patient fit compliance information (e.g., less likely to indicate that the patient is wearing the medical device when the patient is not actually wearing it).

[0071] Additionally, by providing improved wear compliance information to the patient's physician, physicians can receive prompt alerts for any non-compliance by the patient. Given the reliability of the underlying wear compliance information described herein, physicians can act with greater confidence. In response to such alerts, physicians can take action to correct the non-compliance before any potential adverse events occur in the patient that could have been avoided if the patient had followed the wear compliance information associated with the wearable medical device.

[0072] In some cases, the systems and methods described herein provide patients with improved wear compliance information. For example, patients can access wear compliance information or receive alerts about specific conditions that may or may not be met based on the improved wear compliance information. For example, if a patient is deemed not to have worn a medical device for a predetermined period of four hours, the patient may receive a prompt on their phone to wear the medical device. Thus, by providing patients with improved wear compliance information or a portion of improved wear compliance information, patients can monitor and adjust their compliance while limiting or avoiding necessary follow-up from their physician.

[0073] To address these and other embodiments that enhance the performance of patient wear compliance monitoring, systems and processes configured to accurately record wear compliance information are described herein. For example, a wearable defibrillator for providing patient wear compliance information may include a plurality of electrodes configured to monitor the patient's electrical activity and to deliver a therapeutic shock to the patient in response to the detection of cardiac arrhythmias based on the monitored electrical activity. Similarly, a wearable defibrillator may include at least one motion sensor and associated circuitry configured to generate at least one motion signal based on the patient's movement. The wearable defibrillator may further include at least one processor operably coupled to the plurality of electrodes and at least one motion sensor and associated circuitry. In some examples, the at least one processor is configured to receive at least one electrical signal based on the monitored electrical activity from the plurality of electrodes and to record a wear-in event based on an ECG signal detected from the patient's skin and at least one motion signal indicating that the patient is wearing the wearable defibrillator. At least one processor may further be configured to record an end-of-wear event based on one or more of at least one electrical signal and at least one motion signal indicating that the patient is not wearing a wearable defibrillator. This process may be configured to process wear compliance information based on the start and end events and to output a graphical representation of the wear compliance information.

[0074] In a similar example, the processor may be configured to detect an electrocardiogram (ECG) signal from one or more electrical signals and to determine one or more start and end events based on changes in the ECG signal. In some examples, the processor may be configured to perform skin-sensing on one or more electrodes. interfaceThe processor may be configured to detect impedance levels and determine one or more start and end events based on changes in impedance levels. In some examples, the processor may be configured to determine or confirm start and / or end events based on motion signals indicating patient movement. In another example, the processor may be configured to update start and end event criteria based on measured time.

[0075] The benefits and advantages of these technologies provided herein, as well as various other similar examples, processes, and approaches, are described in further detail below.

[0076] Patients with an increased risk of sudden cardiac death, unexplained syncope, signs of heart failure, an elevated ejection fraction of less than 45%, less than 35%, or other such thresholds considered by a physician to be of concern, and other similar patients with impaired cardiac health may be prescribed specialized cardiac monitoring and treatment devices. The wear compliance monitoring functions and / or processes described herein in relation to WCD may be applied in substantially similar manner to HWD.

[0077] The various monitoring processes described herein are implemented either on the WCD or HWD device itself, or on a data processing device such as a remote server system that communicates with or is otherwise associated with the WCD or HWD. For example, at least some steps of the processes described herein may be performed on a server, and one or more of the results of such steps may be implemented by the device.

[0078] In one example, the WCD described herein may include the LifeVest® wearable electrical defibrillator from Zoll Medical Corporation (Chelmsford, Massachusetts). As will be described in more detail below, such a device includes a garment configured to be worn around the torso of a patient. The garment may be configured to house various components, such as an ECG sensing electrode, therapeutic electrodes, one or more accelerometers configured to measure patient motion data, one or more voice and / or vibration sensors configured to record vibration signals, such as the patient's cardiac vibration signal, and one or more RF sensors configured to measure RF-based physiological signals. The components within the garment may be operably connected to a monitoring device located in a separate housing (which may be waterproof and / or protected from the ingress of dust or other physical particles) configured to receive and process signals from the ECG sensing electrode to determine the patient's cardiac condition and, if necessary, control the delivery of treatment to the patient via the therapeutic electrode.

[0079] The HWD may include two or more adhesive ECG sensing and / or therapeutic electrodes coupled via cables to a monitoring device located in a housing similar to that described above for the WCD.

[0080] The WCD monitoring devices described herein are configured to monitor the wear initiation and wear termination events described herein, and to calculate wear compliance information based on the monitored events.

[0081] Figures 1A and 1B show various examples of patient 100 wearing one or more sensors, including sensing electrodes embedded in garments, accelerometers, sound and / or vibration sensors, RF sensors, stretch or pressure sensors, and other similar sensors described herein. In this specification, accelerometers are described as an example of motion sensors for illustrative purposes only. Additional motion sensors, such as gyroscopes, magnetic sensors, pressure-based motion sensors, and other similar motion sensors, may be used in specific implementations.

[0082] As shown in Figure 1A, patients may be prescribed portable medical devices such as a WCD (or HWD for hospital-bound patients). A WCD may include a controller 102 operably connected to one or more sensing electrodes 104 and therapeutic electrodes 106. Additional details of examples of the controller 102, sensing electrodes 104 and therapeutic electrodes 106 can be found in the description of Figure 3 below.

[0083] The WCD may also include one or more accelerometers or other motion sensors. As shown in Figure 1A, the WCD may include three accelerometers 108a, 108b, and 108c (collectively referred to as accelerometers 108) placed at various locations on the patient 100's body. For example, accelerometer 108a may be placed in front of the patient 100's chest, accelerometer 108b may be placed on the patient's back, and accelerometer 108c may be integrated into the controller 102. Each of the accelerometers 108 may be configured to measure motion associated with the patient 100 and output an electrical signal indicating the direction and magnitude of the patient's motion.

[0084] The number and arrangement of accelerometers 108 shown in Figures 1A and 1B are for illustrative purposes only. In a particular implementation, the number and location of accelerometers 108 may differ. Additionally, when included in a device such as a WCD, one or more of the accelerometers 108 may be integrated into the WCD's components. For example, as described above, accelerometer 108c may be integrated into the WCD's controller 102. Similarly, one or more of the accelerometers 108a and 108b may be integrated into one or more components of the WCD. For example, the forward accelerometer 108a may be integrated into a therapeutic electrode 106, for example, which is operably connected to the controller 102 and configured to provide a therapeutic shock to the patient 100. In some implementations, accelerometer 108a may be integrated into one of the sensing electrodes 104, which are generated by the patient 100 and configured to measure an electrical signal indicating the patient's cardiac activity. Similarly, the accelerometer 108b may be integrated into one or more components of the WCD, such as a connection node, at least one sensing electrode 104, a treatment electrode 106, and other similar components of the WCD described herein. Alternatively, or additionally, one or more accelerometers 108 may be separate components of the WCD.

[0085] In an HWD implementation, accelerometers may be integrated into one or more of the following: adhesive ECG detection and / or treatment electrode patches. For example, a first accelerometer may be integrated into a first adhesive ECG detection, and / or a treatment electrode patch and a second accelerometer may be integrated into a second adhesive ECG detection and / or treatment electrode patch. Additional accelerometers may be located within a controller associated with the HWD (similar to the controller 102 of the WCD).

[0086] In addition to the accelerometer associated with WCD described above in relation to Figure 1A, patients such as patient 100 may also be fitted with additional sensors. As shown in Figure 1B, patient 100 may be fitted with a vibration sensor 110 configured to record the patient's bio-vibration signals. For example, the vibration sensor 110 may be configured to detect patient vibrations associated with, for example, cardiac and pulmonary activity. In a particular implementation, the vibration sensor 110 may be configured to detect cardiac vibration values ​​including one or all of S1, S2, S3, and S4. From these cardiac vibration values, a specific cardiac vibration metric or combination metric including one or more of electromechanical activation time (EMAT), left ventricular contraction time (LVST), or left ventricular contraction time percentage (%LVST) may be calculated. In some examples, the vibration sensor 110 may include a vibration sensor configured to detect vibrations from the patient's cardiac system and to provide an output signal response to the detected cardiac vibration values. The vibration sensor 110 may also include a multi-channel accelerometer, such as a 3-channel accelerometer configured to detect motion in each of three orthogonal axes, so that patient movement / position can be detected and correlated with the detected cardiac vibration values. For the subsequent analysis described below, the vibration sensor 110 can transmit information describing the cardiac vibration values ​​to, for example, a sensor interface.

[0087] Additionally, patient 100 may be fitted with an RF sensor 112. For example, the RF sensor 112 may be configured to assess fluid levels and accumulations within the patient's body tissues using RF-based technology. For instance, the RF sensor 112 may be configured to measure fluid content in the lungs for the diagnosis and follow-up of pulmonary edema or pulmonary congestion, typically in patients with heart failure. Similarly, the RF sensor may be configured to measure thoracic fluid content in a patient. In a particular implementation, the RF sensor 112 may include one or more antennas configured to direct radio frequencies through the patient's tissue and measure an output radio frequency signal in response to these frequencies having passed through the tissue. In a particular implementation, the output radio frequency signal may include parameters indicating fluid levels within the patient's tissue. For the subsequent analysis described below, the RF sensor 112 may transmit information describing the tissue fluid levels to a sensor interface.

[0088] Please note that the sensor placement and number shown in Figures 1A and 1B are for illustrative purposes only. In actual implementations of the wear compliance monitoring systems and methods described herein, the number and location of sensors may vary based on the type of patient monitoring and / or treatment being performed and various other factors.

[0089] To properly acquire and output signals indicating patient movement or lack thereof, accelerometers, as described above, can be configured to output one or more output signals indicating any detected movement or motion. For example, as shown in Figure 2, accelerometer 200 can be configured to measure motion along three axes: the x, y, and z axes. Depending on the orientation of accelerometer 200 and the output configuration of the accelerometer, each axis can define the motion of the accelerometer in a particular direction.

[0090] Additionally, as shown in Figure 2, the accelerometer 200 may be configured to provide one or more outputs 202. In this example, the outputs 202 may include X-out (i.e., a signal indicating motion measured along the x-axis), Y-out (i.e., a signal indicating motion measured along the y-axis), and Z-out (i.e., a signal indicating motion measured along the z-axis).

[0091] In some implementations, an accelerometer, such as accelerometer 200, may be configured to output electrical signals of each output 202 having one or more controlled characteristics, such as voltage. For example, accelerometer 200 may be configured to output signals of each output 202 between 0 and 5 volts. In some examples, the output voltage of each output 202 may be directly proportional to the measured motion on the corresponding axis. For example, if accelerometer 200 is configured to measure acceleration motion as a measure of gravity, the accelerometer may be configured to measure g-forces within a specific range, such as -5g to +5g. In such an example, the output voltage of each output 202 may be directly proportional to the measured g-force on each axis. For example, if no g-force is measured (i.e., accelerometer 200 is stationary), each output signal 202 may be measured at 2.5 volts. If motion with a positive g-force along an axis is measured, the voltage of the corresponding output 202 may rise. Conversely, if motion with a negative g-force along an axis is measured, the voltage of the corresponding output 202 may fall. Based on these outputs 202, the processor can determine one or more motion parameters about the patient, such as those described herein, which are used to determine whether the patient is actively wearing a medical device. Additional details regarding such a process are provided below.

[0092] Table 1 below shows the sample voltage output levels of an accelerometer configured to measure -5g to +5g and output a signal from 0 to 5 volts. [Table 1] [Table 1]

[0093] The sample g-forces and voltages shown in Table 1 above are provided as illustrative examples only and are not intended to represent the only possible implementations of the concepts described herein. Therefore, the measured g-force range and the corresponding output voltage may vary depending on the design and capabilities of the accelerometer used. For example, an output voltage of 10 volts may correspond to a measured g-force of 5 g. For example, an output voltage of 15 volts may correspond to a measured g-force of 5 g. For example, an output voltage of 20 volts may correspond to a measured g-force of 5 g. Similarly, an output voltage of 2 volts may correspond to a measured g-force of 1 g. For example, an output voltage of 4 volts may correspond to a measured g-force of 1 g. For example, an output voltage of 6 volts may correspond to a measured g-force of 1 g.

[0094] Figure 3 shows an exemplary component-level diagram of a medical device controller 300 included in a wearable medical device such as a WCD or HWD as described herein. The medical device controller 300 is one example of the controller 102 shown in Figures 1A and 1B. As shown in Figure 3, the medical device controller 300 may include a therapeutic supply circuit 302 configured to provide one or more therapeutic shocks to a patient via at least two therapeutic electrodes 320 (e.g., the therapeutic electrode 106 described above), data storage 304, a network interface 306, a user interface 308, at least one rechargeable battery 310 (e.g., one in a battery chamber configured for such purposes), a sensor interface 312 (e.g., one that interfaces with both an ECG sensing electrode 322 (e.g., the sensing electrode 104 described above) and non-ECG physiological sensors 323 such as vibration sensors (e.g., vibration sensor 110, lung fluid sensor (e.g., RF sensor 112), infrared and near-infrared based pulsed oxygen sensors, blood pressure sensors), a cardiac event detector 316, and a housing 301 configured to house at least one processor 318.

[0095] In some examples, the patient monitoring medical device may include a medical device controller 300 that contains components similar to those described above, but does not include the treatment supply circuit 302 and the treatment electrode 320 (shown by the dotted line). In other words, in certain implementations, the medical device may contain only the ECG monitoring component and not provide treatment to the patient. In such implementations, the structure of the patient monitoring medical device is similar in many respects to the medical device controller 300, but does not need to include the treatment supply circuit 302 and the associated treatment electrode 320.

[0096] As further shown in Figure 3, the controller 300 may further include an accelerometer interface 330 and a set of accelerometers 332. The accelerometer interface 330 may be operably coupled to each of the accelerometers 332 and may be configured to receive one or more outputs from the accelerometers. The accelerometer interface 330 may further be configured to condition the output signals by, for example, converting analog accelerometer signals to digital signals (if analog accelerometers are used), filtering the output signals, and combining the output signals into combined directional signals (e.g., combining each x-axis signal into a combined x-axis signal, each y-axis signal into a combined y-axis signal, and each z-axis signal into a combined z-axis signal). In some examples, the accelerometer interface 330 may be configured to filter the signals using a high-pass or band-pass filter to separate the motion-induced patient acceleration from the gravity-induced acceleration component.

[0097] Additionally, the accelerometer interface 330 may configure outputs for further processing. For example, the accelerometer interface 330 may be configured to arrange the outputs of the individual accelerometers 332 as vectors representing the x, y, and z axis acceleration components received from each accelerometer. The accelerometer interface 330 may be operably coupled to the processor 318 and configured to transfer output signals from the accelerometers 332 to the processor for further processing and analysis.

[0098] As described above, one or more of the accelerometers 332 (e.g., accelerometer 108 described above) may be integrated into one or more components of a medical device. For example, as shown in Figure 3, accelerometer 332 (e.g., accelerometer 108c described above) may be integrated into a controller 300. In some examples, accelerometer 332 may be integrated into one or more of the therapeutic electrode 320, sensing electrode 322, physiological sensor 323, and other components of the medical device. If the controller 300 is included in the HWD, the accelerometer may be integrated into an adhesive ECG sensing and / or therapeutic electrode patch.

[0099] As described herein and as stated above, this disclosure includes monitoring medical device wear compliance for patients. More specifically, the wear compliance information monitored herein includes a precise overview of where a patient wore a medical device, or for what percentage of a particular period of time, and how this compares to the expected wear for a patient prescribed by, for example, a healthcare provider when a medical device is prescribed. Figure 4 shows an exemplary reduced component-level diagram of a medical device controller 300, including a processor 318 configured to monitor patient wear compliance information as described herein. For example, as shown in Figure 4, the processor 318 may include a wear compliance detector 402. Note that the wear compliance detector 402 is shown to be integrated into the processor 318. However, such a design is shown only as an example. In a particular implementation, the wear compliance detector 402 may be integrated as a separate processing component operably coupled to the processor 318. The wear compliance detector 402 may be implemented as a dedicated microprocessor and associated circuitry located on a printed circuit board (PCB) together with the other components described herein. The mounting compliance detector 402, if implemented in a dedicated microprocessor or integrated into processor 318, may be based on a set of processor-readable instructions configured to be executed by the dedicated microprocessor or processor 318. For example, these instructions may be implemented in programming languages ​​such as C, C++, assembly language, machine code, HDL, or VHDL. In the example, the dedicated microprocessor may be an Intel-based microprocessor such as an X86 microprocessor, or a Motorola 68020 microprocessor, each of which may use a different set of binary code and / or instructions for similar functionality. The dedicated microprocessor or processor 318 is shown in Figures 5 to 7. B It can be configured to implement the detection of the start and end events of the fitting process as described in [reference].

[0100] As further shown in Figure 4, the mounting compliance detector 402 may include a start event detector 404 and a end event detector 406. As described above, the mounting compliance detector 402 may be a dedicated microprocessor and associated circuitry placed on the PCB together with other components described herein. In an implementation, a first microprocessor may be implemented as the start event detector 404, and a second microprocessor may be implemented as the end event detector 404. In some implementations, both the start event detector 404 and the end event detector 406 may be implemented on the same microprocessor as described above. If the start event detector 404 and / or the end event detector 406 are implemented on a dedicated microprocessor or integrated into processor 318, they may be based on a set of processor-readable instructions configured to be executed by the dedicated microprocessor or processor 318. For example, these instructions may be implemented in a programming language such as C, C++, assembly language, machine code, HDL, or VHDL. In the example, the dedicated microprocessor may be an Intel-based microprocessor such as an x86 microprocessor, or a Motorola 68020 microprocessor, each of which may use a different set of binary code and / or instructions for similar functions. The dedicated microprocessor or processor 318 is shown in Figures 5 to 7. B The detection of the start and / or end of the fitting event described in [reference] can be implemented.

[0101] As described above, when a patient is wearing a medical device, the on-wearing initiation event can be determined based on an analysis of signals received from one or more of the sensors described herein. For example, based on monitoring of signals output by the ECG sensing electrode and signals output by the accelerometer 332, the initiation event detector 404 may determine an initiation event indicating that the patient is wearing or otherwise attaching the medical device. Similarly, the termination event detector 406 may determine from monitoring an termination event indicating that the patient is turning off, removing, or otherwise stopping the medical device. Based on the measured initiation and termination events, the on-wearing compliance detector 402 and / or the processor 318 may determine on-wearing compliance information about the patient. Exemplary operations performed by the processor 318, the on-wearing compliance detector 402, and the initiation event detector 404 and termination event detector 406 are shown in Figures 5 to 7. B Further details will be provided in the following explanation.

[0102] Figure 5 shows a sample process flow for monitoring and outputting patient fitment compliance information as described herein. For example, the sample process 500 shown in Figure 5 may be implemented by a processor, such as the processor 318 of the medical device controller 300 described above.

[0103] As shown in Figure 5, the processor can receive one or more sensor signals from one or more patient sensors (502). For example, the sensor signals may include signals from one or more physiological sensors, such as an ECG sensor, an RF-based physiological sensor, a bioacoustic sensor, and other similar sensors. The sensor signals may also include signals from one or more motion sensors, such as an accelerometer. signal This may also include: In some examples, the signal may also include electrical signals from one or more sensors, from which various electrical parameters, such as impedance measurements, can be measured.

[0104] The processor may monitor (504) the received signals for indication of a wear compliance initiation event. As described herein, a wear compliance initiation event, or simply an initiation event, is one or more monitored signal changes that indicate a transition from a state in which the patient is not wearing a wearable medical device to a state in which the wearable medical device is wearing. For example, as described herein, a patient is considered to be wearing a wearable medical device if a predetermined threshold based on ECG signal information is met. As an example, the following is an exemplary implementation of such a function, which is reproduced as a sample function specification listing various functions and / or requirements for implementation by the processor of a medical device controller, for example. ● The QRS complex is identified based on a dual criterion of amplitude and duration. In one example, the Pan Tompkins algorithm is used to detect the QRS complex. For example, the wearing time (e.g., "WearTimeStart") begins after a predetermined time called "WearTimePreOnPeriod" (e.g., 5 seconds of the QRS signal or another preset value, or a dynamically changing value). ●WearTimePreOnPeriod: Dynamic change in duration: If the signal is noisy (e.g., indicated by the variable ECGnoiseFlagMask), the predetermined time may be extended. For example, it may be extended by about 10 seconds to allow more ECG samples to be collected. ● Dynamic changes to the predetermined duration WearTimePreOnPeriod: If a QRS sample is detected within a predetermined portion of the WearTimePreOnPeriod duration, for example, the predetermined portion may be set to 80%. This means that compliance tracking begins (WearTimeStart) if the double criteria are met for 80% of WearTimePreOnPeriod. Otherwise, the WearTimePreOnPeriod duration is extended by an additional period, for example, 3 seconds. The above dynamic check is then repeated over the extended WearTimePreOnPeriod duration. WearTimePreOnPeriod is reset when the total duration reaches a predetermined maximum value (for example, 15 seconds).

[0105] In certain implementations, the processor may be configured to receive user input indicating that a patient is wearing a wearable medical device. Depending on the implementation, the processor may monitor one or more additional signals to confirm that a patient is wearing the medical device described herein.

[0106] During monitoring (504), the processor can determine (506) whether an initiation event has occurred. If the processor determines (506) that an initiation event has not occurred, the processor can continue monitoring (504) the electrical signals for an initiation event. Conversely, if the processor determines (506) that an initiation event has occurred, the processor can record the initiation event and monitor (508) the electrical signals for a wear compliance termination event. For example, as described herein, a wear compliance termination event, or simply a termination event, is one or more monitored signal changes indicating that the patient has transitioned from wearing the wearable medical device to not wearing the wearable medical device.

[0107] As further shown in Figure 5, during monitoring (508), the processor can determine (510) whether a termination event has occurred. If the processor determines (510) that a termination event has not occurred, the processor can continue monitoring electrical signals for a termination event. Conversely, if the processor determines (510) that a termination event has occurred, the processor can determine (512) wear compliance information for the period between the start and end events. The processor can then output (514) the wear compliance information to, for example, a remote server for storage and analysis. Additionally, the processor may be configured to output (514) at least some of the wear compliance information in notifications to the patient, the patient's care provider, and the prescribing physician. In one such example, the output notification may include, for example, any recorded changes in the patient's wear compliance that exceed a compliance change threshold. For example, if the patient's wear compliance rate changes by more than a certain amount in a day (e.g., 5% to 15% over several consecutive days), the notification may include information about the change in wear compliance.

[0108] To properly record compliance information, the processor can record event information in tables or other similar data structures. For example, for each of the start and end events measured within a specific period, the processor can record the associated occurrence time for each event. The processor can further calculate and record the total wear compliance time by calculating the time between the start event and the subsequent end event. Similarly, the processor can further calculate and record the total wear non-compliance time by calculating the time between the end event and the subsequent start event. If wear compliance is calculated daily, the processor may record the end event at midnight as a time transition from one day to another, and immediately record the start event at midnight as well. Such recording provides multi-day boundaries without recording any non-compliant periods.

[0109] Table 2 below shows a sample data structure for recording the wear compliance information described herein. As shown, Table 2 contains wear compliance information calculated on a daily basis, and therefore includes pairs of end and start events at midnight each day. Table 2 also includes the total time between events (time segments) and the total overall daily wear measurements (cumulative daily on time, cumulative daily off time, and total daily compliance %). [Table 2] [Table 2]

[0110] As described above, the processor may be configured to monitor one or more electrical signals for the occurrence of an initiation event. However, in certain implementations, the processor may be configured to monitor and rely on changes in signals for indication of an initiation event. For example, process 600 shown in Figure 6A includes a more detailed process flow for monitoring a sensor signal (504) and determining whether an initiation event has occurred (506). In certain implementations, the sensor signal may include a combination of signals, such as physiological signals and motion signals. Process 620 shown in Figure 6B includes a more specific implementation in which one or more physiological signals of a patient are monitored for indication of an initiation event. Process 640 shown in Figure 6C includes a more specific implementation in which one or more motion signals are monitored for indication of an initiation event. Process 660 shown in Figure 6D includes a more specific implementation in which one or more skin-sensor interface impedance levels are monitored for indication of an initiation event.

[0111] As described above, process 600 shown in Figure 6A is shown in Figure 5 and provides a more detailed process flow for monitoring (504) and determining (506) as described above. As shown in Figure 6A, the processor can monitor (602) the received signal. The processor can identify (604) any changes in the received signal that may indicate the occurrence of an initiation event. The processor can determine (606) whether a change indicates an initiation event by, for example, comparing the change in the received signal against one or more initiation event criteria. Examples of specific initiation event criteria are described in the following description of Figures 6B and 6C.

[0112] As further shown in Figure 6A, if the processor determines (606) that the received signal change does not indicate a start event, the processor can continue searching for and identifying (604) the received electrical signal change. However, if the processor determines (606) that the received signal change indicates a start event, the processor can continue monitoring (608) the change. For example, depending on the type of start event criterion used to determine the occurrence of a start event, the electrical signal change must be maintained or observed for a specific period, such as 5 seconds. The processor can determine (610) based on the extended monitoring of the change whether the potential start event is a confirmed start event. If the processor does not determine (610) that the potential start event is a confirmed start event, the processor can continue searching for and identifying (604) the received signal change. Conversely, if the processor determines (610) that the potential start event is a confirmed start event, the processor can generate a confirmation of the start event (612) and record the start event in a data structure such as Table 2 above.

[0113] In some examples, wearable medical devices may include a user interface that provides the patient with options to input various types of information. For example, the user interface may provide the user with an input indicating that they are wearing the wearable medical device. In response to such input, the processor may identify and record an onset event using a process similar to that shown in Figure 6A by analyzing at least one of one or more physiological signals and / or motion signals. In some examples, the processor may record an onset event based solely on the patient's input.

[0114] As described above, process 600 shown in Figure 6A relates to detecting an onset event by holistically monitoring signals received from one or more sensors as described herein. Process 620 shown in Figure 6B is a more detailed process flow for monitoring (504) and determining (506) as shown in Figure 5 and described above, and illustrates a process flow in which physiological information about the patient is monitored and analyzed to determine, for example, the occurrence of an onset event. As shown in Figure 6B, the processor can receive (622) signals from one or more physiological sensors and associated circuits configured to output one or more electrical signals indicating the patient's cardiac activity, such as an ECG sensor as described herein. The processor can derive (624) one or more physiological metrics from the received physiological signals. For example, physiological metrics may include, for instance, heart rate (mean, median, mode, or other statistical measurements of heart rate, and / or maximum, minimum, resting, pre- and post-exercise heart rate values ​​and / or ranges), heart rate variability metrics, ventricular premature contraction (PVC) load or count, atrial fibrillation load metrics, pauses, heart rate turbulence, QRS height, QRS width, changes in size or shape of ECG information morphology, cosine RT, artificial pacing, QT interval, QT variability, T wave width, T wave, T wave variability, and ECG metrics including ST segment changes. ECG metrics are described herein merely as examples, and additional physiological metrics, such as those described, for example, in the detailed description in Figure 3 below, may also be processed by this process.

[0115] As further shown in Figure 6B, the processor can determine whether a derived metric indicates an initiation event (626) by, for example, comparing the changes and / or patterns of the metric in the received signal against one or more initiation event criteria. For example, one initiation event criterion that may indicate an initiation event is an ECG signal that is determined to be valid over a particular period of time. In a particular implementation, at least one ECG parameter derived from the ECG signal should satisfy an effectiveness threshold for the ECG signal that is determined to be valid. The processor may satisfy the effectiveness thresholds described in the following examples using exemplary criteria. For example, the ECG parameter may include a set of at least five consecutive R peaks having R peak amplitudes that satisfy an R peak amplitude threshold. For example, the R peak amplitude threshold may be about 0.75 millivolts to 1.50 millivolts. In some examples, the R peak amplitude threshold may be selected from about 0.50 millivolts to about 1.0 millivolts. In another example, at least one ECG parameter may include a QRS composite width. In one such example, the validity threshold for a valid ECG signal may include five or more consecutive QRS complexes with a time range of approximately 0.05 to 0.15 seconds. As illustrated, the following is an exemplary sample functional specification listing various functions and / or requirements for implementation by a medical device processor. ● QRS complexes are identified based on a dual criterion of amplitude and duration. In one example, the Pan Tompkins algorithm is used to detect QRS complexes. After a predetermined time, e.g., WearTimePreOnPeriod (e.g., 5 seconds of the QRS signal, or another preset value, or a dynamically changing value), the wearing time (WearTimeStart) begins (the effectiveness criterion is met). The following are options for determining when the effectiveness criterion is met. ○ A set of at least five consecutive R peaks having R peak amplitudes that satisfy the R peak amplitude threshold. The R peak amplitude threshold can be approximately 0.75 millivolts to 1.50 millivolts. Optionally, the R peak amplitude threshold can be selected from approximately 0.50 millivolts to approximately 1.0 millivolt. ○ A user-defined value can be set for the QRS complex width. Five or more consecutive QRS complexes with a width of approximately 0.05 seconds to 0.15 seconds.

[0116] As further shown in Figure 6B, if the processor determines (626) that the derived metric does not indicate an initiation event (e.g., the validity criteria are not met), the processor can continue deriving the metric from the received physiological signal (624). However, if the processor determines (626) that the derived metric in the received physiological signal indicates an initiation event (e.g., the validity criteria are met), the processor can continue monitoring (628) the derived metric. As described above, in this example, five consecutive R peak amplitudes should exceed the R peak amplitude threshold to satisfy the exemplary set of validity criteria. The processor can determine (630) whether the derived metric indicates confirmation of an initiation event. If the processor does not determine (630) that the potential initiation event is a confirmed initiation event, the processor can continue deriving the metric based on the received physiological signal. Conversely, if the processor determines (630) that a potential start event is a confirmed start event, the processor generates a confirmation of the start event (632), and can record the start event in a data structure such as Table 2 above.

[0117] Process 640, shown in Figure 6C, is a more detailed process flow for monitoring (504) and determining (506) as shown in Figure 5 and described above, and illustrates a process flow in which motion information about the patient is monitored and analyzed to determine, for example, the occurrence of an initiation event. As shown in Figure 6C, the processor can receive (642) signals from one or more motion sensors and associated circuits configured to output one or more electrical signals indicating the patient's physical activity or movement, such as an accelerometer as described herein. The processor can identify (644) one or more features in the motion signals indicating a particular movement of the patient. For example, the motion signals may provide an indication that the patient is walking, running, climbing stairs, getting up, standing, sitting, lying down and performing other similar physical activities.

[0118] As further shown in Figure 6C, the processor can determine whether an identified motion feature indicates an initiation event (646) by determining, for example, whether the motion and movement features of a wearable medical device worn by a patient match. For example, the output of an accelerometer may be compared to past motion information about the patient. If the motion feature matches the past motion information, the patient may be considered to be wearing a wearable medical device.

[0119] As further shown in Figure 6C, if the processor determines (646) that the identified features in the motion signal do not indicate an initiation event, the processor can continue identifying (644) the features in the received motion signal. However, if the processor determines (646) that the identified features in the motion signal do indicate an initiation event, the processor can continue monitoring (648) the motion signal. For example, to be considered a valid motion, the motion signal may need to indicate that the movements of the patient and the wearable medical device are synchronized over a period of time, such as 5 seconds. The processor can determine (650) whether the motion signal and the identified features in the motion signal indicate confirmation of an initiation event. If the processor does not determine (650) that the potential initiation event is a confirmed initiation event, the processor can continue identifying (644) the features in the received motion signal. Conversely, if the processor determines (650) that the potential initiation event is a confirmed initiation event, the processor can generate (652) an initiation event confirmation and record the initiation event in a data structure such as Table 2 above.

[0120] In addition to the analysis of physiological and motion signals described above, additional signal analysis may be performed by the processor to determine the onset event. For example, the processor may measure the skin-sensor interface impedance level for each sensor coupled to the patient's body. When the medical device is first configured or otherwise programmed, the acceptable impedance range may be selected by the user, such as a device technician. For example, the acceptable impedance range may be selected by design to be approximately 20 ohms to 250 ohms, approximately 20 ohms to 10 kilohms, approximately 20 ohms to 20 kilohms, approximately 250 ohms to 1 kilohm, and approximately 1 kilohm to 20 kilohms. Other acceptable impedance ranges may be implemented during the design phase, programming phase, testing phase and other similar evaluation periods shown in the following exemplary implementation of sample pseudocode for the processor of the medical device controller. ● Measure the skin-electrode interface impedance. ● The impedance value remains within 5% of the user-defined value for a predetermined time, e.g., WearTimePreOnPeriod (e.g., 5 seconds), after which the wearing time (e.g., WearTimeStart) begins (effectiveness criteria are met). The following are options for determining when the effectiveness criteria are met. ○The measured skin-electrode interface impedance is within the user-defined impedance range of approximately 20 ohms to approximately 250 ohms. ○The measured skin-electrode interface impedance is within the user-defined impedance range of approximately 20 ohms to approximately 10 kiloohms. ○The measured skin-electrode interface impedance is within the user-defined impedance range of approximately 20 ohms to approximately 20 kiloohms. ○The measured skin-electrode interface impedance is within the user-defined impedance range of approximately 250 ohms to approximately 1 kilohm. Or, ○The measured skin-electrode interface impedance is within the user-defined impedance range of approximately 1 kilohm to approximately 20 kilohms.

[0121] Based on the measurement of changes in impedance levels, the processor can determine whether an initiation event has occurred. For example, in one implementation depending on a particular design choice, if the sensor is not in contact with the patient's skin, the impedance may exceed 10 kilohms. If the sensor is in contact with the patient's skin, the impedance may drop significantly. Therefore, if the processor measures a skin-sensor interface impedance level of approximately 20 ohms to approximately 250 ohms, it can determine that the sensor is in contact with the patient's skin and an initiation event has occurred. In some examples, the impedance level for detecting an initiation event may be approximately 10 ohms to approximately 300 ohms. In actual implementations, the impedance level may be determined based on the materials used to construct the sensor and the placement of the sensor on the patient. For example, depending on the type of sensor used, the impedance level during an initiation event may be within an acceptable impedance range, e.g., approximately 250 ohms to approximately 1 kilohm or approximately 1 kilohm to approximately 20 kilohms.

[0122] More specifically, Figure 6D shows a sample process flow 660 for monitoring (504) and determining (506) as shown in Figure 5, in which skin-sensor interface impedance levels are monitored and analyzed for one or more sensors coupled to the patient's body in order to determine, for example, the occurrence of an initiation event. As shown in Figure 6D, the processor can receive (662) electrical signals from one or more sensors and associated circuits contained within, for example, a conditioning and / or skin-sensor interface modeling circuit described in, for example, U.S. Patent Application No. 15 / 381,206, entitled “Electrode Falloff Detection,” filed December 16, 2016, the entire content of which is incorporated herein by reference. Based on the received electrical signals, the processor can determine (664) the skin-sensor interface impedance level for each of the one or more sensors coupled to the patient's body.

[0123] As further shown in Figure 6D, the processor can further determine whether the skin-sensor interface impedance level of one or more sensors indicates an initiation event (666) by determining, for example, whether the current skin-sensor interface impedance level of one or more of the sensors indicates that the sensor is currently in contact with the patient's skin. For example, as described above, if the current skin-sensor interface impedance level of a sensor is between approximately 20 ohms and approximately 250 ohms, the processor may determine (666) that the sensor is in contact with the patient's skin and an initiation event may be occurring. Conversely, if the current skin-sensor interface impedance level of a sensor is outside the above impedance range and / or exceeds a specific impedance value such as 10 kilohms or 20 kilohms, the processor may determine (666) that the sensor is not in contact with the patient's skin and an initiation event is unlikely to be occurring. In such an example, the processor can continue to determine (664) the updated skin-sensor interface impedance level for each of the one or more sensors.

[0124] As further shown in Figure 6D, if the processor determines (666) that the current skin-sensor interface impedance level indicates a potential initiation event, the processor may continue monitoring (668) the skin-sensor interface impedance level. For example, the processor may continue monitoring the skin-sensor interface impedance level for a set period, such as 2 seconds, 5 seconds, 10 seconds, 15 seconds, 20 seconds, and / or 30 seconds. During the set period, the processor may determine (670) whether the skin-sensor interface impedance level of one or more sensors, and any changes in the skin-sensor interface impedance level monitored during the set period, indicate confirmation of an initiation event. For example, if the monitored skin-sensor interface impedance level of each of one or more sensors remains within the range of approximately 20 ohms to approximately 250 ohms throughout the entire set period, the processor may determine (670) and confirm that an initiation event has occurred. Conversely, if the monitored skin-sensor interface impedance level of each of one or more sensors remains within the range of approximately 20 ohms to approximately 250 ohms, the processor may determine (670) and confirm that an initiation event has occurred. interface If the impedance level is outside the above impedance range for the set period, the processor may determine (670) that no confirmed start event has occurred and may continue determining the skin-sensor interface impedance level (664) as described above. If the processor determines (670) that a potential start event is a confirmed start event, the processor generates a confirmation of the start event (672) and can record the start event in a data structure such as Table 2 above.

[0125] Process 700, shown in Figure 7A, is shown in Figure 5 and provides a more detailed process flow for monitoring (508) and determining (510) termination events as described above. As shown in Figure 7A, the processor can monitor (702) the received signal. The processor can identify (704) any changes in the received signal that may indicate the occurrence of a termination event. The processor can determine (706) whether a change indicates a termination event by, for example, comparing the change in the received signal against one or more termination event criteria.

[0126] As further shown in Figure 7A, if the processor determines (706) that the received signal change does not indicate a termination event, the processor can continue searching for and identifying (704) the received electrical signal change. However, if the processor determines (706) that the received signal change indicates a termination event, the processor can continue monitoring (708) the change. For example, depending on the type of termination event criterion used to determine the occurrence of a termination event, the electrical signal change must be maintained or observed for a specific period, such as 5 seconds. The processor can determine (710) based on the extended monitoring of the change whether the potential termination event is a confirmed termination event. If the processor does not determine (710) that the potential termination event is a confirmed termination event, the processor can continue searching for and identifying (704) the received signal change. Conversely, if the processor determines (710) that the potential termination event is a confirmed termination event, the processor can generate a confirmation of the termination event (712) and record the termination event in a data structure such as Table 2 above.

[0127] In a specific example of process 700 shown in Figure 7A, the criteria for determining a termination event may vary. For example, if a valid ECG signal transitions to an invalid ECG signal indicating removal of the wearable medical device, the processor may record a termination event. Similarly, if the processor detects a change in skin-sensor interface impedance level indicating removal of the sensor from the patient's skin and that the impedance threshold has been exceeded, or if the skin-sensor interface impedance level is no longer within an acceptable impedance range, the processor may record a termination event. In some examples, the impedance threshold may include at least one of 10 kilohms, 20 kilohms, 100 kilohms, 1 megahm, 2 megahms, 5 megahms, and 10 megahms. In some examples, if the processor stops receiving signals from one or more motion sensors, the processor may determine that one or more motion sensors and associated circuits have been disconnected and record a termination event accordingly. The processor may further determine that one or more changes in motion signals indicate that the patient has removed the wearable medical device and record a termination event accordingly. In some examples, the processor may receive input from the patient indicating that the patient has removed the wearable medical device. The processor may confirm that the patient has removed the wearable medical device based on changes in one or more physiological signals and one or more motion signals, and may record a termination event accordingly.

[0128] In certain implementations, the determination of an initiation event may be based on a combination of signals. Therefore, the examples shown in Figures 6B, 6C, and 6D are presented as examples only. For example, as shown in Figure 6A, the processor may be configured to simultaneously monitor both one or more physiological signals and one or more motion signals to determine whether or not an initiation event has occurred. For example, the processor may determine a valid ECG signal as described in Figure 6B. However, before confirming that an initiation event has occurred, the processor may further analyze one or more motion signals as described in Figure 6C to confirm that one or more motion signals also provide indication of an initiation event. Conversely, if the processor does not detect the indicated motion within the motion signal, or detects a high level of noise within the motion signal, the processor may record an initiation event based solely on the analysis of one or more physiological signals. Similarly, the processor may further monitor the skin-sensor interface impedance level as described in Figure 6D simultaneously with the monitoring of physiological signals and / or motion signals to determine and confirm an initiation event. Conversely, skin-sensor sensors exhibiting potential noise and / or other similar interference in one or more sensors... interface When the processor determines a change in impedance level, it can confirm the start event described herein by relying on further analysis of one or more physiological and / or motion signals. Similarly, the processor can analyze different types and combinations of signals before confirming the end event shown in Figure 7A.

[0129] However, in certain cases, additional variables may affect the reliability of one or more signals. For example, a patient's movement may be limited at certain times. For instance, a patient's movement may be limited at night, and therefore the criteria used to determine start and end events may be adjusted accordingly. In such an example, the processor may be configured to record start and / or end events based on one or more physiological signals, one or more motion signals, and time.

[0130] Process 720, shown in Figure 7B, includes time consideration and adjusts the event criteria accordingly. As shown in Figure 7B, the processor can monitor the received signals (722). The processor can identify any changes in the received signals that may indicate the occurrence of either a start or end event (724). Additionally, the processor can determine the time (726) and compare that time to, for example, past patient activity data or other similar setting information that may indicate whether the patient is typically active or inactive at that time. Based on the determined time and patient activity information, the processor can adjust the event criteria used to determine the occurrence of a start or end event (728). For example, if the time indicates that the patient is generally inactive, the processor may reduce its reliance on one or more motion signals or completely ignore one or more motion signals when determining the occurrence of an event. Conversely, if the determined time indicates that the patient is generally active, the processor may rely on a combination of both one or more physiological signals and one or more motion signals when determining the occurrence of an event.

[0131] As further shown in Figure 7B, the processor can determine (730) whether a change indicates an event by comparing the received signal change against one or more event criteria, such as the adjusted event criteria determined above. If the processor determines (730) that the received signal change does not indicate an event, the processor can continue searching for and identifying (724) the received electrical signal change. However, if the processor determines (730) that the received signal change indicates an event, the processor can continue monitoring (732) the change using, in some cases, the adjusted event criteria. The processor can determine (734) whether a potential event is a confirmed event based on the extended monitoring of the change. If the processor does not determine (734) that a potential event is a confirmed event, the processor can continue searching for and identifying (724) the received signal change. Conversely, if the processor determines (734) that a potential event is a confirmed event, the processor can generate an event confirmation (736) and record the event in a data structure such as Table 2 above. In certain implementations, the processor may be further configured to provide an indication in the data structure that an event has been recorded based on the time the event occurred, using a coordinated event criterion.

[0132] In the above description of Figures 5 to 7B, it should be noted that start and end event detection and confirmation may be performed by monitoring one or more received electrical signals for physiological signals such as ECG signals. Based on the validity of the ECG signal, the processor described herein can determine whether a start or end event has occurred. However, during normal operation of the wearable medical device described herein, the processor can also continuously monitor the patient for cardiac arrhythmias. In certain implementations, if a cardiac arrhythmia occurs, the processor may interpret the resulting ECG as invalid. For example, if a patient experiences ventricular fibrillation (VF), the QRS complex timing detected in the patient's ECG signal may be modified so that the ECG signal is considered invalid for the purpose of determining wear compliance as described herein. In such an example, the processor may be programmed or otherwise configured to prioritize arrhythmia detection over start and / or end event detection, and to ignore or otherwise stop start and / or end event detection, until arrhythmia detection stops (e.g., no arrhythmia is detected) or until the patient receives treatment and returns to normal (or within an acceptable range of normal cardiac activity).

[0133] As described herein, a wearable medical device may be operably connected to one or more additional remotely located computing devices, such as a remote server. For example, Figure 8 shows a sample network 800 in which a wearable medical device (e.g., a medical device including the medical device controller 300 shown in Figure 3) may be operably connected to a remote server. As described above in relation to Figure 3, the wearable medical device controller 300 may include a network interface 306 for transmitting data over a wireless link such as a Bluetooth® wireless link, a broadband cellular link, or a Wi-Fi® communication link based on the IEEE 802.11 standard (e.g., via a “hotspot” or other base station or intermediate device). As shown in Figure 8, the physician’s computer 802 and the wearable medical device 804 may be operably connected to a monitoring server 808 via the network 806. In a particular implementation, the wearable medical device 804 may collect patient-related information, such as various patient metrics and parameters described herein, while being worn. For example, the wearable medical device 804 can collect patient-related physiological and ECG data, RF-based measurement information, and wear compliance information over the period during which the patient is prescribed the wearable medical device. The wearable medical device 804 can also collect accelerometer data showing patient-related movement information, such as the number of steps taken during periods such as 30 minutes, 1 hour, 2 hours, 6 hours, or 1 day, and duration information related to the duration of activity, such as how often and for how long the patient exercises. Depending on the connection to the network 806 and the programming of the wearable medical device 804, the wearable medical device may be configured to regularly transmit the collected information to the monitoring server 808 for storage and further processing and analysis. The network 806 may be a private and secure network configured to enable mutual communication between authorized devices 804, computer 802, and server 808.For example, a private network can be implemented as a virtual private network (VPN) formed using multiple encrypted communication techniques, including the creation of secure communication channels (called "tunnels") within a public network. As an example, device 804 or computer 802 may implement a temporary or persistent dedicated communication software application to securely communicate with server 808 over such a tunnel. The dedicated communication software application encrypts messages and sends them to server 808, and server 808... Rame The message can be received and decrypted. Some types of such dedicated communication software applications may embed the encrypted message in a formatted data packet, so that the encrypted message is unreadable from outside the secure communication channel.

[0134] When prescribing a wearable medical device as described herein, the prescribing physician or healthcare provider may be given one or more options for adjusting various settings or parameters of the wear compliance monitoring process. For example, Figure 9 shows a sample diagram of a user interface screen 900 that may be accessed and used by a physician and / or other HCP to modify one or more wear compliance monitoring settings for a particular patient. The physician may interact with the user interface screen 900 by accessing an application such as a browser or gateway application running on a processor integrated into the physician's computer 802 mentioned above.

[0135] As shown in Figure 9, the user interface screen 900 includes user interface controls 902, 904, 906, 908, and 910. In some examples, the user interface screen 900 provides access to patient-specific information, such as the patient's name, an identifier associated with the patient, and information about prescribed devices, such as a device identifier. In a particular implementation, the patient identifier may be a number that directly identifies the patient, such as a medical record number associated with the patient, an insured person number associated with the patient, a social security number, or another similar identification number. Based on the patient-specific information, the processor can access the patient's medical records. Based on the information contained in the medical records, such as patient status information, historical patient information, demographic information, and rehabilitation-based lining information, the processor can generate a set of default fit compliance monitoring parameters without additional information from the physician.

[0136] In some examples, the processor may present physicians with options for customizing wear compliance monitoring parameters. For example, user interface control 902 may provide access to specific information related to minimum wear compliance monitoring parameters. User interface control 902 may include one or more additional controls 903 that may include one or more user-interactive or selectable inputs for receiving additional information related to minimum wear compliance monitoring parameters. For example, additional controls 903 may include a total wear time field, the number of approved removal periods, and the maximum allowed removal time per removal period. For example, as shown in Figure 9, additional controls 903 may include a combination of text fields and dropdown menus. However, this specific implementation of additional controls 903 is shown as an example only. In this example, additional controls 903 receives physician inputs of a total wear time of 23 hours per day, two allowed removal periods, and a maximum time of 30 minutes per removal period. Specific inputs and sample figures included in additional controls 903 are provided as examples only.

[0137] As described above, the user interface screen 900 may further include user interface controls 904. User interface controls 904 can provide access to specific information related to target wear compliance monitoring parameters. For example, target wear compliance monitoring parameters may include goals set by a physician that the patient should achieve during the time the wearable medical device is prescribed to the patient. User interface controls 904 may include one or more additional controls 905 that may include one or more user-interactive or selectable inputs for receiving additional information related to the target wear compliance monitoring parameters. For example, additional controls 905 may include a total wear time field, the number of approved removal periods, and the maximum removal time allowed per removal period. For example, as shown in Figure 9, additional controls 905 may include a combination of a text field and a dropdown menu. However, this specific implementation of additional controls 905 is shown merely as an example. In this example, additional controls 905 receive physician inputs of a total wear time of 23.5 hours per day, one allowed removal period, and a maximum time of 30 minutes per removal period. However, please note that the specific inputs and sample digits included in the additional control 905 are provided for illustrative purposes only.

[0138] As described above, the user interface screen 900 may further include user interface controls 906. User interface controls 906 can provide access to specific information related to the start and end event detection criteria described herein. User interface controls 906 may include one or more additional controls 907. In some examples, one or more additional controls 907 may include one or more user-interactive or selectable inputs for receiving additional information related to the start and end event detection criteria. For example, an additional control 907 may include a user-selectable input for using default criteria or a user-selectable input for using custom criteria.

[0139] As described above, the user interface screen 900 may further include user interface controls 908. User interface controls 908 can provide access to specific information related to alert criteria for alerting one or more people, such as a physician, another HCP, the patient, and other similar persons, about patient wear compliance information. User interface controls 908 may include one or more additional controls 909. In some examples, one or more additional controls 909 may include one or more user-interactive or selectable inputs to indicate which criteria should be met before an alert is generated. For example, an additional control 909 may include a set of user-selectable inputs for receiving alerts daily that minimum compliance information is not met, after a set number of consecutive days have passed since the minimum compliance information was not met, for receiving alerts daily that target compliance information is not met, after a set number of consecutive days have passed since the target compliance information was not met, and for receiving alerts after a set number of consecutive days have passed since the target compliance information was met. The specific inputs in the additional control 909 include user-selectable inputs and a combination of customizable fields that a physician may use to provide additional information, such as the number of days shown in Figure 9. However, the numbers, placement, and labels of the additional control 909 shown in Figure 9 are for illustrative purposes only.

[0140] As further shown in Figure 9, the user interface control 910 includes a set of selectable buttons. In response to receiving a selection of the "Submit" button, the processor can update a set of wear compliance parameters for the patient. In response to receiving a selection of the "Clear" button, the processor can delete existing selections and / or input information from the user interface screen 900. In response to receiving a selection of the "Cancel" button, the processor can abort the update of the wear compliance parameters as described above.

[0141] As described herein, wear compliance information generated by a wearable medical device may be transmitted to a remote server for additional processing and access, for example, for review by the patient's physician. Additionally, wear compliance information may be displayed to the patient on a user interface integrated into the wearable medical device (e.g., user interface 308 shown in Figure 3 and described herein) or via a personal computing device, such as a smartphone, that is assigned to the patient or otherwise accessed by the patient.

[0142] In certain implementations, fit compliance information may be displayed to care providers via a network-based portal, such as a physician's web portal. For example, the portal may be accessed on a variety of electronic devices, such as a portable computing device assigned to the physician or otherwise accessed by the physician, or a computer, such as the physician's computer 802 shown in Figure 8 and described herein. It is desirable to provide physicians with relevant information about patient fit compliance in an easily understandable format. Furthermore, as mentioned above, physicians may want to set up alerts for deviations by patients from minimum or target fit compliance guidelines. Figures 10A to 10C illustrate one or more interfaces for supplying fit compliance information to physicians, including, for example, a summary screen (or part of a screen) that displays key compliance data for quick viewing, and a more detailed screen (or part of a screen) that contains very detailed information underlying the key compliance data displayed on the summary screen.

[0143] For example, Figure 10A shows a sample user interface screen 1000 containing a sample set of hypothetical patient data for demonstration purposes only. User interface screen 1000 may include sets of data such as patient information, login information, and other similar overall data. User interface screen 1000 may further include a set of tabs 1002 containing more specific summary information about the patient. As shown in Figure 10A, the compliance tab is selected and a set of summary fitting compliance data is displayed. For example, summary fitting compliance information includes reporting period information, reporting scope information, and patient usage scope information. As shown in Figure 10A, reporting period information includes information about patient usage days, total patient usage information, average daily patient usage information, and alert days. Similarly, as shown in Figure 10A, reporting scope information includes a user-selectable input to adjust the total period shown on user interface screen 1000. Patient usage scope includes a user-selectable input to adjust how additional detailed information is displayed on user interface screen 1000.

[0144] As further shown in Figure 10A, the user interface screen 1000 may include a detail section 1004 containing more specific wear compliance information about the patient. A user-selectable input for patient wear range is set to view by actual wear time. In light of this user selection, the data included in the detail section 1004 is formatted based on the total wear time per day, organized in a bar graph 1006. The time for the day is provided on the y-axis, and the date is provided on the x-axis. As shown in Figure 10A, the bar graph 1006 may further include an indication of patient wear compliance compared to patient wear non-compliance.

[0145] Note that the information provided in detail section 1004 is shown as a bar graph 1006 in Figure 10A, merely as an example. Upon receiving an indication that the user-selectable input for patient usage range has been changed, the processor that generated the user interface screen 1000 can update detail section 1004 accordingly. For example, as shown in Figure 10B, the user-selectable input for patient usage range has been changed to "View by total usage time," and detail section 1004 may be updated to include a line graph 1008. As shown in Figure 10B, the line graph 1008 includes the total daily wearing time on the y-axis and the date on the x-axis. Thus, the line graph 1008 provides a quick view of any trends in total wearing compliance for the patient, such as the total number of hours the patient wore the medical device each day and recorded changes in wearing compliance for the patient.

[0146] In some examples, graphic representations, such as bar graph 1006 and line graph 1008, may include viewing wear compliance information that covers the entire period a patient is prescribed a wearable medical device. For example, a patient may be prescribed a device for 90 days. At the end of the 90-day prescription period, the physician can view the wear compliance information for the entire period in a single graphic representation. In some examples, the prescription period may be modified. For example, the prescription period may be 7 days, 14 days, 30 days, 60 days, 180 days, 1 year, and other similar periods. In certain implementations, the physician may modify the graphic representation to view only a portion of the wear compliance information. For example, if the prescription period is 90 days, the physician may modify one or both of bar graph 1006 and line graph 1008 to show a portion of the period, such as 5 days, 1 week, 2 weeks, or 30 days.

[0147] In a particular implementation, the user interface screen may further include one or more user-selectable interface controls configured to provide access to recorded ECG information for one or more of the start event, end event, and the period during which the patient wore the wearable medical device. For example, each of the bar graph 1006 and line graph 1008 may include one or more user-selectable interface controls for accessing recorded ECG information. For example, as shown in Figure 10B, the line graph 1008 may include one or more user-selectable interface controls 1010 embedded in a graphical representation of the wearer compliance information. Upon receiving a selection of one of the controls 1010, the user interface screen may be updated to include additional information, such as recorded ECG information. For example, as shown in Figure 10C, the window 1012 obtains an overlaid user interface screen 1000 containing additional information related to the selected control 1010. For example, window 1012 may include ECG recording information 1014a recorded during the initial start event, intermediate ECG recording information 1014b recorded between the start and end events, and ECG recording information 1014c recorded at the end event. The recorded ECG information shown in Figure 10C is included as an example only, and in some implementations, additional information such as information derived from one or more motion signals described herein, impedance information, ECG metric information, time information, and other similarly recorded information may be displayed or otherwise provided on the user interface screen 1000.

[0148] As described above in the explanation of Figure 9, a physician can set one or more alert criteria for receiving alerts about patient fitting compliance information. As shown in Figure 10D, the user interface screen 1000 can also display an overlaid alert 1016 indicating one or more alerts about patient fitting compliance information. For example, as shown in Figure 10D, alert 1016 indicates that the patient failed to meet minimum compliance information on September 13, 2015, and has failed to meet target compliance information over the past six days. Note that the position on screen 1000 and the overall alert, including the information contained herein as shown in Figure 10D, are provided as examples only. Therefore, the information contained in the alert may differ depending on the physician's settings.

[0149] In addition to providing care providers such as physicians with information on wear compliance, it may be desirable to provide this information to patients themselves. Providing patients with immediate, instantaneous, or readily available feedback on their wear compliance allows them to immediately recognize non-compliance, thereby giving them an opportunity to correct compliance deficiencies without physician intervention. Additionally, positive feedback may provide patients with further motivation to maintain good wear compliance.

[0150] Figures 10E and 10F show sample feedback regarding patient wear compliance information that may be provided to the patient. The feedback may be transmitted to a personal computing device, such as the patient's smartphone, for processing and display. For example, a processor integrated into the personal computing device may process the feedback information and display it on the personal computing device's display. For example, as shown in Figure 10E, the device may display a user interface screen 1018. The user interface screen 1018 may contain a high-level overview of the patient's information. For example, as shown in Figure 10E, the user interface screen 1018 may contain wear compliance streak information, today's wear information, mean daily heart rate information, and activity information about the patient.

[0151] In certain implementations, the device may further provide additional information related to wear compliance. For example, as shown in Figure 10F, the device may display a user interface screen 1020 that includes additional, more specific wear compliance information about the patient. For example, user interface screen 1020 may include a graph of today's wear time, including highlighted portions of the time the device was worn and the time the device was not worn. User interface screen 1020 may further include active streak information indicating that the patient was compliant with wear requirements, such as the total number of consecutive days, and historical information on how the current streak compares to past wear compliance streaks. User interface screen 1020 may also include information such as wear compliance information for the current week.

[0152] The wear compliance information shown in Figures 10E and 10F is provided as an example only. In a particular implementation, the type of information provided to the patient may vary based on, for example, input from the patient's physician, the type of wearable medical device prescribed to the patient, the expected compliance standards for the patient, and other similar parameters.

[0153] It should be noted that the provision of fitting compliance information in a graphical representation accessible via the aforementioned web portal is provided as an example only. In a particular implementation, the provision of fitting compliance information (e.g., the output of fitting compliance information shown in Figure 5 and described above (514)) may also include the generation of a report that can be electronically transmitted to one or more recipients, such as the patient's physician. The report may include various data described herein, filtered based on criteria set, for example, by the patient's physician. The report may be organized according to daily, weekly, monthly or other similar periods and may include fitting compliance information for the patient over those periods. The report may also include charts and / or graphs similar to those shown in Figures 10A and 10B and described above.

[0154] The teachings of this disclosure may generally apply to external medical monitoring and / or therapeutic devices including one or more sensors as described herein. Such external medical devices may include, for example, portable medical devices as described herein that can and are designed to move with the patient as the patient performs their daily tasks. Exemplary portable medical devices may be wearable medical devices, such as WCDs, wearable cardiac monitoring devices, in-hospital devices such as in-hospital wearable defibrillators (HWDs), short-term wearable cardiac monitoring and / or therapeutic devices, mobile cardiac event monitoring devices, and other similar wearable medical devices.

[0155] Wearable medical devices can enable continuous use by patients. In some implementations, continuous use may be de facto, substantially, or nearly continuous. That is, a wearable medical device may be used continuously, except for sporadic periods when use is temporarily interrupted (e.g., while the patient is bathing, while the patient is fitting new and / or different garments, while the battery is being charged / changed, while the garment is being washed and ironed, etc.). Such substantially or nearly continuous use as described herein may nevertheless be considered continuous use. For example, a wearable medical device may be configured to be worn by a patient for as long as 24 hours a day. In some implementations, the patient may remove the wearable medical device for a short period of the day (e.g., 30 minutes for bathing).

[0156] Furthermore, wearable medical devices may be configured as medical devices for long-term or prolonged use. Such devices may be configured to be used by patients for extended periods of time, such as days, weeks, months, or even years. In some examples, a wearable medical device may be used by a patient for an extended period of at least one week. In some examples, a wearable medical device may be used by a patient for an extended period of at least 30 days. In some examples, a wearable medical device may be used by a patient for an extended period of at least one month. In some examples, a wearable medical device may be used by a patient for an extended period of at least two months. In some examples, a wearable medical device may be used by a patient for an extended period of at least three months. In some examples, a wearable medical device may be used by a patient for an extended period of at least six months. In some examples, a wearable medical device may be used by a patient for an extended period of at least one year. In some implementations, prolonged use may not be interrupted until a physician or other HCP provides the patient with specific instructions to stop using the wearable medical device.

[0157] Regardless of the duration of wear, the use of a wearable medical device may include continuous or near-continuous wear by the patient, as described above. For example, continuous use may include continuous wear or attachment of the wearable medical device to the patient, for example through one or more of the electrodes described herein, during both the monitoring period and the period during which the device may not be monitoring the patient but is still being worn by or attached to the patient for other reasons. A wearable medical device may be configured to continuously monitor the patient for cardiac-related information (e.g., ECG information including arrhythmia information, cardiac oscillations, etc.) and / or non-cardiac information (e.g., blood oxygen, patient body temperature, glucose levels, tissue fluid levels, and / or lung oscillations). The wearable medical device may perform monitoring at periodic or aperiodic time intervals or durations. For example, monitoring during these intervals or durations may be triggered by user behavior or other events.

[0158] As described above, wearable medical devices may be configured to monitor other non-ECG physiological parameters of a patient in addition to cardiac-related parameters. For example, wearable medical devices may be configured to monitor, among other things, lung vibrations (e.g., using a microphone and / or accelerometer), expiratory vibrations, sleep-related parameters (e.g., snoring, sleep apnea), and tissue fluid (e.g., using a radio frequency transmitter and sensors).

[0159] Other exemplary wearable medical devices include automated cardiac monitors and / or defibrillators for use in specific special conditions and / or environments, such as in combat zones or in emergency vehicles. Such devices may be configured to be immediately (or substantially immediately) used in life-saving emergency situations. In some examples, the portable medical devices described herein may be pacable and, for example, capable of providing therapeutic pacing pulses to a patient. In some examples, the portable medical devices may be configured to monitor and / or measure ECG metrics, including, for example, heart rate (mean, median, mode, or other statistical measures of heart rate, and / or maximum, minimum, resting, pre- and post-exercise heart rate values ​​and / or ranges), heart rate variability metrics, PVC load or count, atrial fibrillation burden metrics, pauses, heart rate turbulence, QRS height, QRS width, changes in size or shape of ECG information morphology, cosine RT, artificial pacing, QT interval, QT variability, T-wave width, T-wave, T-wave variability, and ST-segment changes.

[0160] As described above, Figure 3 shows an exemplary component-level diagram of a medical device controller 300, for example, included in a wearable medical device. As further shown in Figure 3, the therapeutic supply circuit 302 may be coupled to one or more electrodes 320 configured to provide therapy to a patient. For example, the therapeutic supply circuit 302 may include, or be operably connected to, a circuit component configured to generate and provide an electrotherapeutic shock. The circuit component may include, for example, resistors, capacitors, relays and / or switches, electrical bridges such as H-bridges (e.g., including multiple insulated-gate bipolar transistors, i.e., IGBTs), voltage and / or current measuring components and other similar circuit components, arranged and connected such that the circuit component operates in conjunction with the therapeutic supply circuit and is under the control of one or more processors (e.g., processor 318) to provide a patient with at least one therapeutic shock, including one or more pacing electrodefibrillation or defibrillation therapeutic pulses.

[0161] Pacing pulses may be used to treat cardiac arrhythmias such as bradycardia (e.g., less than 30 beats per minute) and tachycardia (e.g., more than 150 beats per minute), for example, using fixed-rate pacing, demand pacing, and anti-tachycardia pacing. Defibrillation pulses may be used to treat ventricular tachycardia and / or ventricular fibrillation.

[0162] The capacitor may include a parallel-connected capacitor bank consisting of multiple capacitors (e.g., two, three, four, or more capacitors). In some examples, the capacitor may include a single-film or electrolytic capacitor as a series-connected device containing a bank of the same capacitors. These capacitors may be switched to a series connection during the discharge of the defibrillation pulse. For example, a single capacitor of approximately 140uF or more, or four capacitors of approximately 650uF each, may be used. These capacitors may have a surge rate of 1600VDC or more per single capacitor, or a surge rate of approximately 350-500VDC for multiple capacitors connected in parallel, and may be charged from the battery pack in approximately 15-30 seconds.

[0163] For example, each defibrillation pulse may deliver energy in the range of 60 to 180 joules. In some implementations, the defibrillation pulse may be a biphasic cleavage exponential waveform, thereby allowing the signal to switch between a positive and a negative portion (e.g., charging direction). This type of waveform may be effective for defibrillating a patient at lower energy levels compared to other types of defibrillation pulses (e.g., single-phase pulses). For example, the amplitude and width of these two phases of the energy waveform may be automatically adjusted to deliver a precise amount of energy (e.g., 150 joules) regardless of the patient's body impedance. The therapeutic supply circuit 302 may be configured to perform switching and pulse supply operations, for example, under the control of a processor 318. As energy is delivered to the patient, the amount of energy being delivered can be tracked. For example, even if the pulse waveform is dynamically controlled based on factors such as the patient's body impedance to which the pulse is being delivered, the amount of energy may be maintained at a predetermined constant value.

[0164] In certain cases, the therapeutic supply circuit 302 may be configured to supply a set of electrical defibrillation pulses, for example, to correct a heart that is beating improperly. Compared to the defibrillation described above, electrical defibrillation typically involves weaker shocks, delivered at a specific frequency to mimic a normal heart rhythm.

[0165] The data storage 304 may include one or more non-temporary computer-readable media, such as flash memory, solid-state memory, magnetic memory, optical memory, cache memory, or a combination thereof. The data storage 304 may be configured to store executable instructions and data used in the operation of the medical device controller 300. In certain examples, the data storage may include executable instructions configured to cause the processor 318 to perform one or more operations when executed. In some examples, the data storage 304 may be configured to store information such as ECG data received from a sensing electrode interface.

[0166] In some examples, the network interface 306 may facilitate information communication between the medical device controller 300 and one or more other devices or entities via a communication network, such as network 806 shown in Figure 8. For example, the medical device controller 300 may be contained within a portable medical device, and the network interface 306 may be configured to communicate with a remote computing device, such as a remote server (e.g., remote server 808 shown in Figure 8), or other similar computing devices. The network interface 306 may include a communication circuit for transmitting such data to an intermediate device in accordance with the Bluetooth® radio standard for short-range data exchange. For example, such an intermediate device may be a base station, a "hotspot" device, a smartphone, a tablet, a portable computing device, and / or other device near the wearable medical device, including the medical device controller 300. The intermediate device may, as a result, communicate data to the remote server via a broadband cellular network communication link. This communication link may implement broadband cellular technology for high-speed wireless communication (e.g., 2.5G, 2.75G, 3G, 4G, 5G cellular standards) and / or Long-Term Evolution (LTE) technology, or GSM® / EDGE and UMTS / HSPA technology. In some implementations, the intermediate device may communicate with the remote server via a Wi-Fi® communication link based on the IEEE 802.11 standard.

[0167] In a particular example, the user interface 308 includes input devices, output devices, and Input device / output device combinationIt may include one or more physical interface devices and a software stack configured to cause these devices to operate. These user interface elements may display visual content, audio content and / or haptic content. Thus, the user interface 308 may receive inputs and provide outputs, thereby enabling the user to exchange information with the medical device controller 300. In a particular implementation, the user interface 308 may be configured to provide the user interface screen 1010 shown in Figure 10D and the user interface screen 1012 shown in Figure 10E to the user of the medical device controller 300.

[0168] The medical device controller 300 may also include at least one rechargeable battery 310 configured to power one or more components integrated into the medical device controller 300. The rechargeable battery 310 may include a rechargeable multi-cell battery pack. In one exemplary implementation, the rechargeable battery 310 may include three or more 2200mAh lithium-ion batteries to power other device components within the medical device controller 300. For example, the rechargeable battery 310 may provide power outputs in the range of 20mA to 1000mA (e.g., 40mA) and support run times of 24 hours, 48 ​​hours, 72 hours, or more between multiple charges. In a particular implementation, battery capacity, run time, and type (e.g., lithium-ion, nickel-cadmium, or nickel metal hydride) may be modified to best suit the specific application of the medical device controller 300.

[0169] The sensor interface 312 may include a physiological signal circuit coupled to one or more sensors configured to monitor one or more physiological parameters of a patient. As shown, the sensors may be coupled to a medical device controller 300 via a wired or wireless connection. The sensors may include one or more ECG sensing electrodes 322, and non-ECG physiological sensors 323 such as a vibration sensor 324, a tissue fluid monitor 326 (e.g., based on an ultra-high-bandwidth RF device), and a motion sensor (e.g., an accelerometer, gyroscope, and / or magnetometer). In some implementations, the sensors may include multiple conventional ECG sensing electrodes in addition to the digital sensing electrodes.

[0170] The sensing electrode 322 may be configured to monitor the patient's ECG information. For example, by design, the digital sensing electrode 322 may include a skin-contact electrode surface that can be considered polarizable or non-polarizable depending on various factors, including the metal and / or coating used in the construction of the electrode surface. All such electrodes may be used in the principles, techniques, devices and systems described herein. For example, the electrode surface may be based on stainless steel, a noble metal such as platinum, or Ag-AgCl.

[0171] In some examples, electrode 322 may be used with an electrolytic gel dispersed between the electrode surface and the patient's skin. In certain implementations, electrode 322 may be a dry electrode that does not require an electrolytic material. For example, such a dry electrode may be based on tantalum metal and may have the aforementioned tantalum pentoxide coating. Such a dry electrode may be more suitable for long-term monitoring applications.

[0172] Referring again to Figure 3, the vibration sensor 324 may be configured to detect cardiac or pulmonary vibration information. For example, the vibration sensor 324 can detect cardiac valve vibration information in a patient. For example, the vibration sensor 324 may be configured to detect cardiac vibration signal values ​​including one or all of S1, S2, S3, and S4. From these cardiac vibration signal values ​​or cardiac vibration values, specific cardiac vibration metrics may be calculated, including one or more of the following: electromechanical activation time (EMAT), mean EMAT, EMAT percentage (%EMAT), cardiac systolic dysfunction index (SDI), and left ventricular systolic time (LVST). The vibration sensor 324 may also be configured to detect cardiac wall movement, for example, by positioning the sensor within the region of the apical impulse. The vibration sensor 324 may include a vibration sensor that can detect vibrations occurring in the trachea or lungs due to airflow during breathing, for example, configured to detect vibrations from the patient's cardiac and pulmonary systems and to provide an output signal in response to detected vibrations in a target organ. In certain implementations, additional physiological information, such as lung oscillation characteristics based on sounds generated within the lungs (e.g., wheezing, crackles, etc.), may be determined from the lung oscillation signal. The vibration sensor 324 may also include a multi-channel accelerometer, for example, a three-channel accelerometer configured to detect motion in each of the three orthogonal axes, so that patient movement / position can be detected and correlated with the detected cardiac oscillation information. For subsequent analysis, the vibration sensor 324 can transmit information describing the cardiac oscillation information to the sensor interface 312.

[0173] The tissue fluid monitor 326 can assess fluid levels and accumulations within a patient's body tissues using RF-based technology. For example, the tissue fluid monitor 326 may be configured to measure fluid content in the lungs, typically for the diagnosis and follow-up of pulmonary edema or pulmonary congestion in patients with heart failure. The tissue fluid monitor 326 may include one or more antennas configured to direct RF waves through the patient's tissue and measure an output RF signal in response to this frequency after it has passed through the tissue. In a particular implementation, the output RF signal includes parameters indicating the fluid level within the patient's tissue. For subsequent analysis, the tissue fluid monitor 326 can transmit information describing the tissue fluid level to the sensor interface 312.

[0174] In a particular implementation, the cardiac event detector 316 may be configured to monitor the patient's ECG signal for the occurrence of a cardiac event, such as an arrhythmia or other similar cardiac event. Working in conjunction with the processor 318, the cardiac event detector may be configured to process the ECG signal received, for example, from the sensing electrode 322, and to perform one or more methods to determine whether the patient is experiencing a cardiac event. The cardiac event detector 316 may be implemented using hardware, or a combination of hardware and software. For example, in some examples, the cardiac event detector 316 may be implemented as a software component stored in data storage 304 and executed by the processor 318. In this example, instructions included in the cardiac event detector 316 may cause the processor 318 to perform one or more methods to determine whether an adverse cardiac event is occurring by analyzing the received ECG signal. In other examples, the cardiac event detector 316 may be an application-specific integrated circuit (ASIC) coupled to the processor 318 and configured to monitor the ECG signal for the occurrence of an adverse cardiac event. Therefore, examples of the cardiac event detector 316 are not limited to a specific hardware or software implementation.

[0175] In some implementations, the processor 318 includes one or more processors (or one or more processor cores), each configured to execute a set of instructions that result in manipulated data and / or to control the operation of other components of the medical device controller 300. In some implementations, when performing a particular process (e.g., cardiac monitoring), the processor 318 may be configured to make a specific logic-based decision based on the received input data, and may also be configured to provide one or more outputs that can be used to control or otherwise notify subsequent processing performed by the processor 318 and / or other processors or circuits to which the processor 318 is communicably coupled. Thus, the processor 318 responds in a particular manner to a particular input stimulus and generates a corresponding output based on that input stimulus. In some exemplary cases, the processor 318 may go through a series of logic transitions, during which the states of various internal registers and / or other internal or external bit cells of the processor 318 may be set to logic high or logic low. As referred to herein, the processor 318 may be configured to perform a function in which software is stored in a data store coupled to the processor 318, and this software performs a series of various logical decisions that result in the execution of this function on the processor 318It is configured to allow the processor 318 to perform certain operations. The various components that can be performed by the processor 318 and are described herein can be implemented in various forms, such as specialized hardware, software, or combinations thereof. For example, the processor 318 may be a digital signal processor (DSP), such as a 24-bit DSP. The processor 318 may be a multicore processor having, for example, two or more processing cores. The processor 318 may be an Advanced RISC Machine (ARM) processor, such as a 32-bit ARM processor or a 64-bit ARM processor. The processor 318 may run an embedded operating system, which may include services provided by this operating system that can be used for file system operations, display and speech generation, basic networking, firewalls, data encryption, and communications.

[0176] As described above, portable medical devices such as WCDs may be designed to include a digital front end in which analog signals detected by the skin-contact electrode surfaces of a set of digital sensing electrodes are converted into digital signals for processing. A typical portable medical device with an analog front end configuration uses circuitry to handle signals from the sensing electrodes with high source impedance (e.g., having an internal impedance range of approximately 100 kilohms to 1 or more megahms). This high source impedance signal is processed and transmitted to a monitoring device, such as the processor 318 of the controller 300 described above, for further processing. In a particular implementation, the monitoring device, or another similar processor such as a microprocessor or another dedicated processor operably coupled to the sensing electrodes, may be configured to receive a common noise signal from each of the sensing electrodes, sum the common noise signals, invert the summed common noise signal, and feed back the inverted signal to the patient as driven ground by canceling out the common mode signal using, for example, a driven right bundle branch circuit.

[0177] Figure 11A shows an exemplary medical device 1100 that is external, portable, and wearable by a patient 1102, and is configured to implement one or more configurations described herein. For example, the medical device 1100 may be a non-invasive medical device configured to be positioned substantially outside the patient. Such a medical device 1100 may be a portable medical device that can move with the patient as the patient performs their daily tasks and is designed to do so. For example, the medical devices 1100 described herein, such as the LifeVest® wearable electrical defibrillator available from ZOL® Medical Corporation, may be attached to the patient's body. Such a wearable defibrillator is typically worn substantially or substantially continuously for a period of two to three months at a time. Such a wearable defibrillator may be configured to continuously or substantially continuously monitor the patient's vital signs during the period it is worn by the patient, and may be configured to deliver one or more therapeutic electrical pulses to the patient when it is determined that treatment is needed. For example, such therapeutic shocks may be pulses of pacing, defibrillation, or transcutaneous electrical nerve stimulation (TENS).

[0178] The medical device 1100 may include one or more of the following, or any combination thereof: a garment 1110, one or more ECG sensing electrodes 1112, one or more non-ECG physiological sensors 1113, one or more therapeutic electrodes 1114a and 1114b (collectively referred to herein as therapeutic electrodes 1114), a medical device controller 1120 (e.g., the controller 300 described above in the description of Figure 3), a connection pod 1130, a patient interface pod 1140, and a belt 1150. In some examples, at least some of the components of the medical device 1100 may be configured to be attached to (or permanently integrated into, in some examples) a garment 1110 which can be worn around the patient's torso.

[0179] The medical device controller 1120 may be operably coupled to a sensing electrode 1112, which may be attached to a garment 1110, for example, by being assembled to the garment 1110, or by being detachably attached to the garment, for example, using hooks and hook-and-loop fasteners. In some implementations, the sensing electrode 1112 may be permanently integrated into the garment 1110. The medical device controller 1120 may be operably coupled to a therapeutic electrode 1114, for example, by being assembled to the garment 1110, or in some implementations, by being permanently integrated into the garment 1110. In one example, the medical device controller 1120 includes a patient user interface 1160 to enable the patient to interface with an externally attached device. For example, the patient can use the patient user interface 1160 to respond to activities related to questions, prompts, and surveys described herein.

[0180] Other component configurations are possible besides those shown in Figure 11A. For example, the sensing electrode 1112 may be configured to be attached to various locations around the patient's body 1102. The sensing electrode 1112 may be operably coupled to the medical device controller 1120 via a connection pod 1130. In some implementations, the sensing electrode 1112 may be attached to the patient 1102 using adhesive. In some implementations, the sensing electrode 1112 and at least one of the therapeutic electrodes 1114 may be contained in a single integrated patch that can be attached to the patient's body using adhesive.

[0181] The sensing electrode 1112 may be configured to detect one or more cardiac signals. Examples of such signals include ECG signals and / or other detected cardiac physiological signals from a patient. In specific examples, non-ECG physiological sensors 1113 may be used, such as accelerometers, vibration sensors, RF-based sensors, and other measuring devices for recording additional non-ECG physiological parameters, as described herein. For example, as described above, such non-ECG physiological sensors may be configured to detect other types of patient physiological parameters and acoustic signals, such as tissue fluid levels, cardiac vibrations, lung vibrations, respiratory vibrations, patient movement, etc.

[0182] In some examples, the therapeutic electrode 1114 may be configured to include a sensor configured to detect the patient's ECG signal and other physiological signals. In some examples, the connection pod 1130 may include a signal processor configured to amplify, filter, and digitize these cardiac signals before transmitting them to the medical device controller 1120. One or more of the therapeutic electrodes 1114 may be configured to deliver one or more therapeutic defibrillation shocks to the patient's body when the medical device 1100 determines that such treatment is warranted based on signals detected by the sensing electrode 1112 and processed by the medical device controller 1120. Exemplary therapeutic electrodes 1114 may include metal electrodes, such as stainless steel electrodes, including one or more conductive gel placement devices configured to supply conductive gel to the metal electrodes before the delivery of therapeutic shocks.

[0183] In some implementations, the medical devices described herein may be configured to switch between a therapeutic medical device and a monitoring medical device configured solely for patient monitoring (e.g., not providing or performing any therapeutic function). For example, therapeutic components and associated circuits, such as therapeutic electrodes 1114, may optionally be disconnected from (or coupled to) the medical device, or switched off from (or on to) the medical device. For example, a medical device may have optional therapeutic elements (e.g., defibrillation electrodes and / or pacing electrodes, components and associated circuits) configured to operate in therapeutic mode. Optional therapeutic elements may be physically disconnected from the medical device to convert a therapeutic medical device for a specific purpose (e.g., for operation in monitoring-only mode) or for a patient into a monitoring medical device. Alternatively, optional therapeutic elements may be deactivated (e.g., via a physical or software switch), thereby effectively converting the therapeutic medical device into a monitoring medical device for a specific physiological purpose or a specific patient. As an example of a software switch, an authorized person can access the protected user interface of a medical device and deactivate the therapeutic elements of the medical device by selecting pre-configured options or performing several other user actions through the user interface.

[0184] Figure 11B shows an external, portable, and patient-wearable in-hospital wearable defibrillator 1100A. In some implementations, the in-hospital wearable defibrillator 1100A may be configured to treat conditions such as bradycardia, tachycardia, and asystolic states, to provide pacing therapy. The in-hospital wearable defibrillator 1100A may include one or more ECG sensing electrodes 1112a, one or more therapeutic electrodes 1114a and 1114b, a medical device controller 1120, and a connection pod 1130. For example, each of these components may be structured as a similar number of components of a medical device 1100 and may function like those components. For example, electrodes 1112a, 1114a, and 1114b may include disposable adhesive electrodes. For example, these electrodes may include sensing and therapeutic components placed on separate sensing and therapeutic electrode adhesive patches. In some implementations, both the detection and treatment components may be integrated and placed on the same electrode adhesive patch, which is then attached to the patient. For example, an anterior adhesive-attachable treatment electrode 1114a is attached to the front of the patient's torso to deliver pacing or defibrillation treatment. Similarly, a posterior adhesive-attachable treatment electrode 1114b is attached to the rear of the patient's torso. In an exemplary scenario, at least three ECG adhesive-attachable detection electrodes 1112a may be attached in a manner directed by a trained professional, at least above the chest near the patient's right arm, above the chest near the patient's left arm, and towards the lower part of the patient's chest.

[0185] Patients being monitored by in-hospital wearable defibrillators and / or pacing devices may be confined to a hospital bed or room for extended periods (e.g., more than 75% of the patient's hospital stay). As a result, the user interface 1160a may be configured to interact with non-patient users, such as nurses, regarding device-related functions, including initial device-based lining, setting and adjusting patient parameters, and changing the device battery.

[0186] In some examples, the in-hospital wearable defibrillator 1100A may further include one or more motion sensors, such as an accelerometer. For example, the accelerometer may be integrated into one or more of the following other components of the in-hospital wearable defibrillator 1100A: the sensing electrode 1112a (e.g., integrated into the same patch as the sensing electrode), the treatment electrode 1114a (e.g., integrated into the same patch as the treatment electrode), the medical device controller 1120, the connection pod 1130, and various other components of the in-hospital wearable defibrillator 1100A.

[0187] In some implementations, an example of a therapeutic medical device including a digital front-end by the systems and methods described herein may include a short-term defibrillator and / or pacing device. For example, such a short-term device may be prescribed by a physician for a patient exhibiting syncope. A wearable defibrillator may be configured to monitor a patient exhibiting syncope by analyzing the patient's physiology and cardiac activity for abnormal patterns that may indicate abnormal physiological function, for example. For example, such abnormal patterns may occur before, during, or after the onset of syncope. In such exemplary implementations of a short-term wearable defibrillator, the electrode assembly may be adhesively attached to the patient's skin and may have a configuration similar to that of the in-hospital wearable defibrillator described above in relation to Figure 11A.

[0188] Figures 11C and 11D show exemplary wearable patient monitoring devices that do not have a procedural or therapeutic function. For example, such a device is configured to monitor one or more physiological parameters of a patient, for example, to remotely monitor and / or diagnose the patient's condition. For example, such physiological parameters may include the patient's ECG information, tissue (e.g., lung) fluid levels, cardiac vibration (e.g., using an accelerometer or microphone), and other relevant cardiac information. The cardiac monitoring device is a portable device that the patient can carry with them while performing their daily tasks.

[0189] Referring to Figure 11C, an exemplary wearable patient monitoring device 1100C may include a tissue fluid monitor 1165 that uses RF-based technology to assess fluid levels and accumulations within a patient's body tissues. Such a tissue fluid monitor 1165 may be configured to measure fluid content in the lungs, typically for the diagnosis and follow-up of pulmonary edema or pulmonary congestion in patients with heart failure. The tissue fluid monitor 1165 may include one or more antennas configured to direct RF waves through the patient's tissue and measure an output RF signal in response to this frequency having passed through this tissue. In a particular implementation, the output RF signal includes parameters indicating the fluid level within the patient's tissue. In the example, device 1100C may also be a cardiac monitoring device that includes a digital sensing electrode 1170 for detecting the patient's ECG activity. Device 1100C may preprocess the ECG signal via one or more ECG processing and / or conditioning circuits, such as an ADC, operational amplifier, digital filter, and signal amplifier, under the control of a microprocessor. The device 1100C can transmit information describing ECG activity and / or tissue fluid levels to a remote server via a network interface for analysis. In addition, in certain implementations, the device 1100C can measure motion signals as described herein. multiple It may include an accelerometer.

[0190] Referring to Figure 11D, another exemplary wearable cardiac monitoring device 1100D may be attached to a patient via at least three adhesive digital cardiac sensing electrodes 1175 positioned around the patient's torso. Additionally, in a particular implementation, the device 1100D may integrate, for example, one or more of the digital sensing electrodes for measuring motion signals as described herein. multiple It may include an accelerometer.

[0191] Cardiac devices 1100C and 1100D are used in cardiac monitoring and telemetry and / or continuous cardiac event monitoring applications, for example, in patient populations complaining of irregular cardiac signs and / or conditions. These devices can transmit information describing ECG activity and / or tissue fluid levels to a remote server via a network interface for analysis. Exemplary cardiac conditions that can be monitored include atrial fibrillation (AF), bradycardia, tachycardia, atrioventricular block, Laung-Gannon-Levine syndrome, atrial flutter, sinoatrial node dysfunction, cerebral ischemia, pauses and / or cardiac palpitations. For example, such patients may be prescribed cardiac monitoring for extended periods, such as 10 to 30 days or more. In some portable cardiac monitoring and / or telemetry applications, a portable cardiac monitoring device may be configured to substantially continuously monitor a patient for cardiac abnormalities, and if such abnormalities are detected, the monitor can automatically transmit data related to the abnormality to a remote server. The remote server may be located within a 24-hour manned monitoring center where data is interpreted by qualified, cardiac-related trained reviewers and / or HCPs, and feedback is provided to the patient and / or designated HCP through detailed periodic or event-triggered reports. For specific cardiac event monitoring applications, the cardiac monitoring device is configured to allow the patient to report symptoms by manually pressing buttons on the device. For example, the patient may report symptoms such as stagnation, shortness of breath, dizziness, heavy heartbeat, fatigue, fainting, chest discomfort, weakness, pseudodizziness, and / or genuine dizziness. The cardiac monitoring device can record predetermined physiological parameters of the patient (e.g., ECG information) over predetermined time periods (e.g., 1 to 30 minutes before and 1 to 30 minutes after the reported symptom). As described above, the cardiac monitoring device may be configured to monitor the patient's physiological parameters other than cardiac-related parameters.For example, a cardiac monitoring device may be configured to monitor, among other things, cardiac vibration signals (e.g., using an accelerometer or microphone), lung vibration signals, expiratory vibrations, sleep-related parameters (e.g., snoring, sleep apnea), and tissue fluid.

[0192] In some examples, the devices described herein (e.g., Figures 11A to 11D) can communicate with a remote server via an intermediate or gateway device 1180, such as the one shown in Figure 11D. For example, the devices shown in Figures 11A to 11D may be configured to include network interface communication capabilities, as described herein with reference to, for example, Figure 3.

[0193] Additionally, the devices described herein (e.g., Figures 11A to 11D) may be configured to include one or more accelerometers as described herein. For example, as described above in the description of Figures 1A and 1B, one or more sensors, such as accelerometers, vibration sensors, and RF sensors, may be integrated into various components of the wearable device or included as standalone sensors configured to measure various signals about a patient.

[0194] While the subject matter included herein has been described in detail for illustrative purposes, it should be understood that such details are for illustrative purposes only, and that this disclosure is not limited to the disclosed embodiments, but rather intended to encompass modifications and equivalent configurations within the appended claims. For example, it should be understood that, wherever possible, this disclosure assumes that one or more features of any embodiment may be combined with one or more features of any other embodiment.

[0195] Other examples are within the scope of this specification and the claims. Additionally, the specific functions described above may be implemented using software, hardware, firmware, hardwiring, or any combination thereof. Furthermore, the features implementing the functions may be physically located (including distributed) in various locations, such that some of these functions are implemented in different physical locations. [Example implementation]

[0196] The medical device controllers described herein may include one or more database tables configured to store wear compliance information. For example, the database tables may include a wear compliance table and a flag table. In some examples, the wear compliance information and flag data may be combined into a single database table. In one example, the database table may store how long the device has been worn, using multiple rows for multiple separate wear periods. A schema for creating such a database table may be as follows:

number

[0197] In some examples, the fit compliance process described herein may utilize ECG signal detection and monitoring to determine compliance. For example, indication of fit compliance can be provided by observing valid ECG data on at least one ECG channel. In various sample implementations, the processor of the medical device controller described herein may be configured to implement functions represented by the following pseudocode. ●When the belt is connected and the detection system is activated, the compliance monitoring module activates compliance tracking. ● Monitor ECG channel 1 and ECG channel 2. ○ The ECG is uniquely captured through four ECG electrodes designed for common-mode noise rejection (for example, those with predetermined bandwidths of 1 MHz to 10 kHz or 10 MHz to 5 kHz). ○Before digitization, the ECG signal is passed to a bandpass filter (0.1Hz~60Hz). ○ The ECG signal is amplified within the dynamic amplifier. ○For example, the amplification level is controlled (e.g., every 2 seconds, every 5 seconds, every 7 seconds, every 10 seconds, every 15 seconds, or at other dynamic durations depending on the rhythm). The amplification level is controlled to ensure that the ECG signal detection module (including the arrhythmia detection module) and the noise detection module receive an optimal level of ECG signal samples.

[0198] The processor may also be configured to determine fit compliance based on a valid ECG signal. For example, the processor may be configured to implement a function represented by the following pseudocode: ● Verify the ECG signal. ○Detect a predetermined QRS wave in at least one of the ECG channels for a predetermined duration. The process identifies QRS complexes based on a dual criterion of QRS complex amplitude and duration. In one example, Pan Tompkins is used to detect QRS. After a predetermined time called "WearTimePreOnPeriod" (e.g., 5 seconds of the QRS signal or another preset value, or a dynamically changing value), the wear time ("WearTimeStart") is started. ○WearTimePreOnPeriod: Dynamic change in duration: If the signal is noisy (indicated by ECGnoiseFlagMask), the predetermined time is extended. For example, it may be extended by about 10 seconds to allow more ECG samples to be collected. ○(Alternative Step 1:) Dynamic change of predetermined duration WearTimePreOnPeriod: If a QRS sample is detected within a predetermined portion of the WearTimePreOnPeriod duration. For example, the predetermined portion may be set to 80%. This means that compliance tracking will begin (WearTimeStart) if the double criterion is met for 80% of WearTimePreOnPeriod. Otherwise, the WearTimePreOnPeriod duration will be extended by an additional period, for example, 3 seconds. Next, the above dynamic check is repeated over the extended WearTimePreOnPeriod duration. WearTimePreOnPeriod is reset when the total duration reaches a predetermined maximum value (e.g., 15 seconds). ○When the threshold level of the QRS signal is not detected and a predetermined time called "WearTimeGoesOffperiod" has elapsed (for example, 5 seconds or another preset value, or a dynamically changing value), the compliance monitoring module indicates that compliance tracking will be paused ("WearTimeEnd"). ○Example of dynamic changes in the predetermined duration WearTimeGoesOffperiod: If no QRS samples are detected over a predetermined portion of the WearTimeGoesOffperiod duration. For example, the predetermined portion may be set to 80%. This means that if the double criterion is not met for 80% of WearTimeGoesOffperiod, compliance tracking will be paused (WearTimeEnd). Otherwise, the WearTimeGoesOffperiod duration is extended by an additional period, for example, 3 seconds. ○The above dynamic check is repeated over the extended WearTimeGoesOffperiod duration. ○WearTimeGoesOffperiod is reset when the total duration reaches a predetermined maximum value (e.g., 15 seconds). In this situation, it means that the ECG signal is still good and patient compliance information indicates that the patient is properly wearing the device. ○ Check if a crossover at midnight has occurred. If so, the compliance tracking routine updates the record and splits this record that crosses midnight into two records. ○For the preceding 24-hour period, the compliance module records the cumulative number of hours and minutes the patient has worn the device. For example, in Figure X, the patient wore the device from 00:00 to 08:00, and then from 10:00 to 23:00. Therefore, the total cumulative duration for the 24-hour period is 22 hours. ○If the belt is disconnected or the system shuts down (which means the detection system is deactivated), compliance monitoring will also pause (WearTimeEnd).

[0199] Figure 12 shows a sample timing diagram 1200 illustrating a visual representation of a patient's wear compliance information over a period of time. In this example, 1200 in the diagram includes a timeline 1202 representing a 24-hour period from 00:00 to 24:00. During this period, the timeline 1202 includes various pieces of information related to the patient's wear compliance, such as the wear period 1204, recorded start events 1206, and recorded end events 1208. Based on the information shown in 1200 in the diagram, a physician, patient, or other similar reviewer can quickly determine which portion of this period the patient was wearing the medical device.

[0200] As further shown in Figure 12, Figure 1200 includes a sample of a detailed view 1210 of a recorded termination event 1208. As shown in the detailed view 1210, a series of measured R waves 1212 are measured during the wear period 1204. The magnitude of the R waves 1210 remains above the minimum R wave magnitude threshold 1214 until the timeline approaches 08:00. As the timeline approaches 08:00, the magnitude of the measured R waves 1212 begins to decrease and crosses the threshold 1214 at 08:00. Thus, at 08:00, the processor performing the compliance monitoring process described herein can record a termination event 1208, ending the wear period 1204. The processor can then continue monitoring for an initiation event 1206, indicating that the patient is wearing the medical device again.

[0201] In some examples, medical devices, such as the wearable medical devices described herein, may be configured to inject or otherwise apply electrical signals to a patient's body. A processor can monitor and measure these electrical signals to determine whether a patient is wearing the medical device and, therefore, to determine wearing compliance. For example, a processor in a medical device controller may be configured to implement functions represented by the following pseudocode. ●For example, a low-level AC signal (called the wear time signal) is applied to the body via a therapeutic electrode. A signal with a predetermined frequency (for example, 800 Hz). For example, it could be in the range of 100Hz to 1MHz. ●A high-pass filter is used in hardware to detect the wear time signal, and the resulting sample is stored in an accumulator. If the output of the accumulator is compared to a predetermined threshold (wear time signal accumulator threshold), the WearTimeStart detection flag may be set. ● The output of the accumulator should remain above a predetermined threshold throughout the dynamic duration described below. ○ After a predetermined period, WearTimePreOnPeriod (for example, 5 seconds when the accumulator output remains above a threshold, or another preset value, or a dynamically changing value) begins the wearing time (WearTimeStart). ○Example 1 of dynamic changes in WearTimePreOnPeriod duration: If the signal is noisy (indicated by ECGnoiseFlagMask), a predetermined time is extended. For example, by extending it to about 10 seconds, it becomes possible to detect additional wear time signal samples for a longer period of time in order to determine whether the wear time signal accumulator threshold is met. ○Example 2 of dynamic changes in a predetermined duration WearTimePreOnPeriod: When a wear time signal sample is detected for a predetermined portion of the WearTimePreOnPeriod duration. For example, the predetermined portion may be set to 80%. This means that compliance tracking starts (WearTimeStart) if the wear time accumulator threshold is met for 80% of WearTimePreOnPeriod. Otherwise, the WearTimePreOnPeriod duration is extended by an additional period, for example, 3 seconds. The above dynamic check is then repeated over the extended WearTimePreOnPeriod duration. WearTimePreOnPeriod is reset when the total duration reaches a predetermined maximum value (for example, 15 seconds). ○When the WearTime signal accumulator threshold is not met, and a predetermined period of time called WearTimeGoesOffperiod (e.g., 5 seconds, another preset value, or a dynamically changing value) has elapsed, the compliance monitoring module indicates that compliance tracking will be temporarily suspended (WearTimeEnd). ○Example of dynamic change of a predetermined duration WearTimeGoesOffperiod: If the wear time signal accumulator threshold is not met over a predetermined portion of the WearTimeGoesOffperiod duration. For example, the predetermined portion may be set to 80%. This means that if the wear time signal accumulator threshold is not met for 80% of the WearTimeGoesOffperiod, compliance tracking will be paused (WearTimeEnd). Otherwise, the WearTimeGoesOffperiod duration will be extended by an additional period, e.g., 3 seconds. The above dynamic check will be repeated over the extended WearTimeGoesOffperiod duration. WearTimeGoesOffperiod will be reset when the total duration reaches a predetermined maximum value (e.g., 15 seconds). In this situation, this means that the wear time signal accumulator threshold is met and patient compliance information indicates that the patient is wearing the device properly. ○ The compliance module checks if a midnight crossover has occurred. If so, the compliance tracking routine updates the record and splits this record that crosses midnight into two records. ○ For the previous 24-hour period, the compliance module records the cumulative number of hours and minutes the patient has worn the device. ● If the belt is disconnected or the system shuts down (which means the detection system is deactivated), compliance monitoring will also pause (WearTimeEnd).

[0202] As described herein, in a particular implementation, a compliance monitoring process may include both physiological signals, such as ECG signals, and motion information, such as the output of one or more accelerometers, as inputs. For example, as shown in Figure 13, the sample input / output Figure 1300 includes one or more ECG signals 1302 and motion information 1304 as inputs to the compliance monitoring process 1306. A processor may be configured to implement the compliance monitoring process 1306 and process the inputs to produce one or more outputs. For example, process 1306 may be configured to output output 1308, which includes an indication of an identified start event and a positive value of the variable WearTimeStart as described herein. Similarly, the process may be configured to output output 1310, which includes an indication of an identified end event and a positive value of the variable WearTimeEnd as described herein. In a particular implementation, if a test period is used to determine whether a start event or an end event has occurred, outputs 1308 and 1310 may also include indications of when the start event and / or end event began. In the example, the processor may be configured to implement one or more additional functions represented by the following pseudocode: ●When motion information (ACC signal) indicates that the patient is walking, running, climbing stairs, or otherwise moving. ○The reliability threshold for such movements is high (e.g., greater than 0.75, 0.8, or other preset values, or dynamically changing values). Next, WearTimeStart may be set. ○In an optional implementation, the ECG signal detection module (see details above) should also output a flag indicating that WearTimeStart may be set. WearTimeStart may be set if both the ACC signal detection module and the ECG signal detection module agree. ○If the ACC signal does not indicate that the patient is walking, running, climbing stairs, or otherwise moving. ○For example, the reliability threshold for motion (determined above) is low. ○During a specific period of the day, SleepPeriod is turned on (for example, it can be configured and is set to 10 PM to 6 AM by default). ■Check heart rate data to verify whether the patient is asleep. ■WearTimeStart may be set if the ACC signal and heart rate data indicate that the patient is asleep. ●In an optional embodiment, the ECG signal detection module (see details above) should also output a flag agreeing that WearTimeStart may be set. ACC signal detection module, heart rate data and ECG signal detection module all If they match, WearTimeStart may be set. ● If the ACC signal does not indicate that the patient is walking, running, or climbing stairs, and SleepPeriod is not on. The ECG signal detection module (see details above) is used to output a flag indicating when WearTimeStart may be set, as described above.

[0203] In addition to the variables enumerated in relation to the database tables described herein, other similar variables may be monitored and recorded in one or more database tables described herein. For example, the variable "totalHoursOfUse" may be recorded and may include data representing the first and last wear-day segments in the calculation. In the example, the variable "averageDailyUse" may be recorded and may include the wear-day segments of days that sum to exceed the minimum daily threshold for daily use. In the example, the variable "totalDays" may be recorded and may include the total number of days the patient wore the medical device. In the example, the variable "totalPatientUsePercent" may be recorded and may include the percentage of time the device was worn relative to a requested date range. In the example, the variable "firstWearDate" may be recorded and may include the first wear-day. In the example, the variable "lastWearDate" may be recorded and may include the last wear-day. In the example, the variable "calendarDate" may be recorded and may include a calendar day. In the example, the variable "dailyCompliance" may be recorded and may include the first and last wear-day segments in which the patient exceeded the minimum daily threshold. In the example, the variable "totalSeconds" may be recorded and may include the combined wear duration of all segments within a given calendar day. In the example, the variable "compliancePercentage" may be recorded and may include the percentage of time the patient wore the medical device on a given day. The variables described herein are provided for illustrative purposes only and are not intended to limit the scope of the database tables described herein.

[0204] The above-described compliance detection process refers to heart rate data. The heart rate used in compliance monitoring may be determined using one or more detection methods or processes. For example, the implementation of heart rate detection may include, but is not limited to, one or more of the following: ● Analysis of ECG time signals: Heart rate is evaluated by measuring the duration between two ECG complexes. ● Derivative-based detector: To detect complexes, a derivative filter is used to enhance the complexes. Next, the filter output is compared with a dynamic threshold to determine whether an ECG complex has been detected. QRS Detector: To detect heart rate, the detector analyzes the slope of the ECG signal to detect the presence of the QRS complex. This is achieved by applying a differential filter. The ECG signal from the ADC is first band-pass filtered (2Hz to 20Hz) to remove baseline fluctuations and high-frequency noise. The output of this band-pass filter is then fed to the QRS detector, which performs slope analysis. If the QRS detector detects the QRS complex and zeros, the output of the QRS detector will be a binary value equal to 1. The QRS rate is evaluated by measuring the duration between two consecutive peaks in the ECG signal and comparing the output to an adapted threshold. Axis detector: To detect complexes, a complex match filter operation is performed to find the similarity between the captured ECG and the incoming ECG. The idea behind the axis detector is to perform waveform feature analysis. This analysis is initiated by capturing ECG waveforms from both channels. The acquired waveforms are compared to the incoming ECG via a complex match filter. If there is sufficient similarity between the captured ECG and the incoming ECG, a match is detected. The matched complexes per minute provide indication of heart rate. ECG Spectrum Analysis: Heart rate can be measured by decomposing the ECG signal into its spectrum. This method is suitable for ventricular tachycardia / fibrillation, where heart rate assessment is often difficult with ECG time signal analysis. The ECG signal to be analyzed is downsampled from 200 Hz to 25 Hz. A spectrum analyzer can decompose this downsampled ECG into its spectrum. Spectral analysis is achieved by calculating the energy distribution in the spectrum. Tachycardia or fibrillation often results in a spectrum that tends to concentrate at specific frequencies corresponding to the heart rate. In the example, spectral analysis may be performed once per second. For example, the index of the maximum peak magnitude between 2 Hz and 6 Hz is determined, and therefore indicates the fundamental frequency. The proportion of power at the fundamental frequency is determined. If this power exceeds a predetermined threshold, the rate can be determined based on the fundamental frequency (e.g., the reciprocal of the frequency value).

Claims

1. A wearable defibrillator for providing patient wearing compliance information, Multiple electrodes configured to be continuously attached to a patient from an external source over a long period of time, wherein the electrodes are configured to monitor electrical activity on the patient's skin and to deliver a therapeutic shock to the patient in response to the detection of cardiac arrhythmias based on the monitored electrical activity; At least one motion sensor and associated circuit configured to generate at least one motion signal based on the patient's movement; and At least one processor operably coupled to the plurality of electrodes and the at least one motion sensor and associated circuitry, Receiving at least one electrical signal based on the monitored electrical activity on the patient's skin from the plurality of electrodes. Recording an on-wear event based on the at least one electrical signal and the at least one motion signal indicating that the patient is wearing the wearable defibrillator. Recording an end-of-wear event based on one or more of the at least one electrical signal or the at least one motion signal indicating that the patient is not wearing the wearable defibrillator, and Based on the recorded fitting start event and the recorded fitting end event, a graphic representation including information about the patient's fitting compliance is output. at least one processor configured to perform Equipped with, Recording the aforementioned mounting start event means Detecting one or more ECG signals based on the aforementioned at least one electrical signal; Determining whether the one or more ECG signals satisfy one or more validity criteria; and If the one or more ECG signals satisfy at least one of the one or more effectiveness criteria, the wearing start event is recorded. Includes, The one or more effectiveness criteria include at least one ECG parameter derived from the one or more ECG signals that satisfy the effectiveness threshold. The at least one ECG parameter includes an R-peak amplitude, and satisfying the validity threshold includes identifying at least five consecutive R-peak amplitudes, each exceeding the amplitude threshold. Wearable defibrillator.

2. A wearable defibrillator for providing patient wearing compliance information, Multiple electrodes configured to be continuously attached to a patient from an external source over a long period of time, wherein the electrodes are configured to monitor electrical activity on the patient's skin and to deliver a therapeutic shock to the patient in response to the detection of cardiac arrhythmias based on the monitored electrical activity; At least one motion sensor and associated circuit configured to generate at least one motion signal based on the patient's movement; and At least one processor operably coupled to the plurality of electrodes and the at least one motion sensor and associated circuitry, Receiving at least one electrical signal based on the monitored electrical activity on the patient's skin from the plurality of electrodes. Recording an on-wear event based on the at least one electrical signal and the at least one motion signal indicating that the patient is wearing the wearable defibrillator. Recording an end-of-wear event based on one or more of the at least one electrical signal or the at least one motion signal indicating that the patient is not wearing the wearable defibrillator, and Based on the recorded fitting start event and the recorded fitting end event, a graphic representation including information about the patient's fitting compliance is output. at least one processor configured to perform Equipped with, Recording the aforementioned mounting start event means Detecting one or more ECG signals based on the aforementioned at least one electrical signal; Determining whether the one or more ECG signals satisfy one or more validity criteria; and If the one or more ECG signals satisfy at least one of the one or more effectiveness criteria, the wearing start event is recorded. Includes, The one or more effectiveness criteria include at least one ECG parameter derived from the one or more ECG signals that satisfy the effectiveness threshold. The at least one ECG parameter includes a QRS composite width, and satisfying the validity threshold includes measuring at least five consecutive QRS composite widths, each between 0.05 seconds and 0.15 seconds. Wearable defibrillator.

3. A wearable defibrillator for providing patient wearing compliance information, Multiple electrodes configured to be continuously attached to a patient from an external source over a long period of time, wherein the electrodes are configured to monitor electrical activity on the patient's skin and to deliver a therapeutic shock to the patient in response to the detection of cardiac arrhythmias based on the monitored electrical activity; At least one motion sensor and associated circuit configured to generate at least one motion signal based on the patient's movement; and At least one processor operably coupled to the plurality of electrodes and the at least one motion sensor and associated circuitry, Receiving at least one electrical signal based on the monitored electrical activity on the patient's skin from the plurality of electrodes. Recording an on-wear event based on the at least one electrical signal and the at least one motion signal indicating that the patient is wearing the wearable defibrillator. Recording an end-of-wear event based on one or more of the at least one electrical signal or the at least one motion signal indicating that the patient is not wearing the wearable defibrillator, and Based on the recorded fitting start event and the recorded fitting end event, a graphic representation including information about the patient's fitting compliance is output. at least one processor configured to perform Equipped with, Recording the aforementioned mounting start event means Determining whether the motion signal indicates the movement of the patient and the wearable defibrillator; and If the motion signal indicates movement of the patient and the wearable defibrillator, record the wear-on event. Includes, The aforementioned at least one processor further, If the motion signal does not indicate the movement of the patient and the wearable defibrillator, one or more ECG signals are detected based on the at least one electrical signal; and Record the fitting start event based on the analysis of the one or more ECG signals. It is configured to do the following: Wearable defibrillator.

4. A wearable defibrillator for providing patient wearing compliance information, Multiple electrodes configured to be continuously attached to a patient from an external source over a long period of time, wherein the electrodes are configured to monitor electrical activity on the patient's skin and to deliver a therapeutic shock to the patient in response to the detection of cardiac arrhythmias based on the monitored electrical activity; At least one motion sensor and associated circuit configured to generate at least one motion signal based on the patient's movement; and At least one processor operably coupled to the plurality of electrodes and the at least one motion sensor and associated circuitry, Receiving at least one electrical signal based on the monitored electrical activity on the patient's skin from the plurality of electrodes. Recording an on-wear event based on the at least one electrical signal and the at least one motion signal indicating that the patient is wearing the wearable defibrillator. Recording an end-of-wear event based on one or more of the at least one electrical signal or the at least one motion signal indicating that the patient is not wearing the wearable defibrillator, and Based on the recorded fitting start event and the recorded fitting end event, a graphic representation including information about the patient's fitting compliance is output. at least one processor configured to perform Equipped with, Recording the aforementioned completion event means that Detecting a change in the at least one electrical signal indicating an invalid ECG signal; and Record the installation completion event based on the invalid ECG signal. including, Wearable defibrillator.

5. A wearable defibrillator for providing patient wearing compliance information, Multiple electrodes configured to be continuously attached to a patient from an external source over a long period of time, wherein the electrodes are configured to monitor electrical activity on the patient's skin and to deliver a therapeutic shock to the patient in response to the detection of cardiac arrhythmias based on the monitored electrical activity; At least one motion sensor and associated circuit configured to generate at least one motion signal based on the patient's movement; and At least one processor operably coupled to the plurality of electrodes and the at least one motion sensor and associated circuitry, Receiving at least one electrical signal based on the monitored electrical activity on the patient's skin from the plurality of electrodes. Recording an on-wear event based on the at least one electrical signal and the at least one motion signal indicating that the patient is wearing the wearable defibrillator. Recording an end-of-wear event based on one or more of the at least one electrical signal or the at least one motion signal indicating that the patient is not wearing the wearable defibrillator, and Based on the recorded fitting start event and the recorded fitting end event, a graphic representation including information about the patient's fitting compliance is output. at least one processor configured to perform Equipped with, Recording the aforementioned completion event means that Determining that one or more of the plurality of electrodes, or at least one motion sensor and associated circuit, is disconnected from the wearable defibrillator; and If it is determined that one or more of the plurality of electrodes, or at least one motion sensor and associated circuit, are disconnected, the mounting completion event is recorded. including, Wearable defibrillator.

6. A wearable defibrillator for providing patient wearing compliance information, Multiple electrodes configured to be continuously attached to a patient from an external source over a long period of time, wherein the electrodes are configured to monitor electrical activity on the patient's skin and to deliver a therapeutic shock to the patient in response to the detection of cardiac arrhythmias based on the monitored electrical activity; At least one motion sensor and associated circuit configured to generate at least one motion signal based on the patient's movement; and At least one processor operably coupled to the plurality of electrodes and the at least one motion sensor and associated circuitry, Receiving at least one electrical signal based on the monitored electrical activity on the patient's skin from the plurality of electrodes. Recording an on-wear event based on the at least one electrical signal and the at least one motion signal indicating that the patient is wearing the wearable defibrillator. Recording an end-of-wear event based on one or more of the at least one electrical signal or the at least one motion signal indicating that the patient is not wearing the wearable defibrillator, and Based on the recorded fitting start event and the recorded fitting end event, a graphic representation including information about the patient's fitting compliance is output. at least one processor configured to perform Equipped with, Recording the aforementioned completion event means that Detecting that the patient has removed the wearable defibrillator based on the analysis of at least one motion signal; Confirm that the patient has removed the wearable defibrillator, and that at least one electrical signal indicates this; and Based on confirmation that the patient has removed the wearable defibrillator, the end-of-wearing event is recorded. including, Wearable defibrillator.

7. A wearable defibrillator for providing patient wearing compliance information, Multiple electrodes configured to be continuously attached to a patient from an external source over a long period of time, wherein the electrodes are configured to monitor electrical activity on the patient's skin and to deliver a therapeutic shock to the patient in response to the detection of cardiac arrhythmias based on the monitored electrical activity; At least one motion sensor and associated circuit configured to generate at least one motion signal based on the patient's movement; and At least one processor operably coupled to the plurality of electrodes and the at least one motion sensor and associated circuitry, Receiving at least one electrical signal based on the monitored electrical activity on the patient's skin from the plurality of electrodes. Recording an on-wear event based on the at least one electrical signal and the at least one motion signal indicating that the patient is wearing the wearable defibrillator. Recording an end-of-wear event based on one or more of the at least one electrical signal or the at least one motion signal indicating that the patient is not wearing the wearable defibrillator, and Based on the recorded fitting start event and the recorded fitting end event, a graphic representation including information about the patient's fitting compliance is output. at least one processor configured to perform Equipped with, The aforementioned at least one processor further, Determining the current time; and Recording at least one of the mounting start event and the mounting end event based on one or more of the at least one motion signal, the at least one electrical signal, and the current time. It is configured to do the following: Wearable defibrillator.

8. A wearable defibrillator for providing patient wearing compliance information, Multiple electrodes configured to be continuously attached to a patient from an external source over a long period of time, wherein the electrodes are configured to monitor electrical activity on the patient's skin and to deliver a therapeutic shock to the patient in response to the detection of cardiac arrhythmias based on the monitored electrical activity; At least one motion sensor and associated circuit configured to generate at least one motion signal based on the patient's movement; and At least one processor operably coupled to the plurality of electrodes and the at least one motion sensor and associated circuitry, Receiving at least one electrical signal based on the monitored electrical activity on the patient's skin from the plurality of electrodes. Recording an on-wear event based on the at least one electrical signal and the at least one motion signal indicating that the patient is wearing the wearable defibrillator. Recording an end-of-wear event based on one or more of the at least one electrical signal or the at least one motion signal indicating that the patient is not wearing the wearable defibrillator, and Based on the recorded fitting start event and the recorded fitting end event, a graphic representation including information about the patient's fitting compliance is output. at least one processor configured to perform Equipped with, The at least one processor is further configured to output a notification of the patient's compliance with the device's fitting, Outputting the notification regarding the patient's compliance with the fitting means Comparing the patient's compliance with the fitting criteria to one or more notification criteria; and If the patient's compliance with the fitting meets at least one of the one or more notification criteria, the notification shall be output. Includes, The one or more notification criteria mentioned above include the patient failing to wear the wearable defibrillator over a certain percentage of the time over a certain period of time. Wearable defibrillator.

9. A wearable defibrillator for providing patient wearing compliance information, Multiple electrodes configured to be continuously attached to a patient from an external source over a long period of time, wherein the electrodes are configured to monitor electrical activity on the patient's skin and to deliver a therapeutic shock to the patient in response to the detection of cardiac arrhythmias based on the monitored electrical activity; At least one motion sensor and associated circuit configured to generate at least one motion signal based on the patient's movement; and At least one processor operably coupled to the plurality of electrodes and the at least one motion sensor and associated circuitry, Receiving at least one electrical signal based on the monitored electrical activity on the patient's skin from the plurality of electrodes. Recording an on-wear event based on the at least one electrical signal and the at least one motion signal indicating that the patient is wearing the wearable defibrillator. Recording an end-of-wear event based on one or more of the at least one electrical signal or the at least one motion signal indicating that the patient is not wearing the wearable defibrillator, and Based on the recorded fitting start event and the recorded fitting end event, a graphic representation including information about the patient's fitting compliance is output. at least one processor configured to perform Equipped with, The at least one processor is further configured to output a notification of the patient's compliance with the device's fitting, Outputting the notification regarding the patient's compliance with the fitting means Comparing the patient's compliance with the fitting criteria to one or more notification criteria; and If the patient's compliance with the fitting meets at least one of the one or more notification criteria, the notification shall be output. Includes, The one or more notification criteria include a recorded change in the patient's wear compliance that exceeds a compliance change threshold. Wearable defibrillator.

10. Recording the aforementioned mounting start event means Detecting one or more ECG signals based on the aforementioned at least one electrical signal; Determining whether the one or more ECG signals satisfy one or more validity criteria; and If the one or more ECG signals satisfy at least one of the one or more effectiveness criteria, the wearing start event is recorded. including, A wearable defibrillator according to any one of claims 4 to 9.

11. The one or more effectiveness criteria include at least one ECG parameter derived from the one or more ECG signals that satisfy the effectiveness threshold. A wearable defibrillator according to claim 10.

12. The at least one processor is further configured to determine the patient's fit compliance based on a first ECG signal among the one or more ECG signals that satisfy the validity threshold. The wearable defibrillator according to claim 11.

13. The system further comprises a display operably coupled to the at least one processor, the at least one processor configured to provide the graphic representation via the display, A wearable defibrillator according to any one of claims 1 to 12.

14. The system further comprises a network interface operably coupled to the at least one processor, the at least one processor being configured to transmit the information relating to the patient's fitting compliance to a remote server. A wearable defibrillator according to any one of claims 1 to 13.

15. The aforementioned at least one processor further, Detecting an electrocardiogram (ECG) signal based on the aforementioned at least one electrical signal; and Controlling the wearable defibrillator to provide the patient with an ECG signal therapeutic shock in response to the detection of the cardiac arrhythmia based on the detected ECG signal. It is configured to do the following: A wearable defibrillator according to any one of claims 1 to 14.

16. Recording the aforementioned mounting start event means Detecting the impedance level of the skin-sensor interface based on the at least one electrical signal from one or more of the plurality of electrodes; Determining whether the impedance level is within an acceptable impedance range; and If the impedance level is within the acceptable impedance range, record the mounting start event; Includes, Recording the aforementioned completion event means that Determining whether the impedance level is no longer within the acceptable impedance range; and Record the end-of-wear event based on the determination that the impedance level is no longer within the acceptable impedance range. including A wearable defibrillator according to any one of claims 4 to 9.

17. The acceptable impedance range includes at least one of the ranges from 20 ohms to 250 ohms, from 250 ohms to 1 kilohm, and from 1 kilohm to 20 kilohms. The wearable defibrillator according to claim 16.

18. Recording the aforementioned mounting start event means Determining whether the motion signal indicates the movement of the patient and the wearable defibrillator; and If the motion signal indicates movement of the patient and the wearable defibrillator, record the wear-on event. including, A wearable defibrillator according to any one of claims 4 to 9.

19. The aforementioned at least one processor further, To detect one or more noise components in the at least one electrical signal; and Confirm that there is no movement of the patient based on an analysis of the one or more noise components in at least one electrical signal. It is configured to do the following: The wearable defibrillator according to claim 3.

20. Recording the aforementioned mounting start event means Receiving input from the patient indicating that the patient is wearing the wearable defibrillator; and Based on the input from the patient, record the fitting start event. including, A wearable defibrillator according to any one of claims 4 to 9.

21. Recording the insertion start event based on the input from the patient is: Confirming that the patient is wearing the wearable defibrillator based on the at least one electrical signal and the at least one motion signal; and Record the aforementioned mounting start event. including, The wearable defibrillator according to claim 20.

22. Recording the aforementioned completion event means that To detect changes in the impedance level of the skin-sensor interface in one or more of the aforementioned electrodes; Determining whether the impedance level exceeds the impedance threshold; and If the impedance level exceeds the impedance threshold, record the completion event. including, A wearable defibrillator according to any one of claims 1 to 4 and 7 to 9.

23. The impedance threshold includes one or more of 10 kilohms, 100 kilohms, 1 megahm, 2 megahms, 5 megahms, or 10 megahms. The wearable defibrillator according to claim 22.

24. Recording the aforementioned completion event means that Receiving input from the patient indicating that the patient has removed the wearable defibrillator; and Based on the input from the patient, record the completion event of the fitting. including, A wearable defibrillator according to any one of claims 1 to 4 and 7 to 9.

25. Recording the end of the fitting event based on the input from the patient is: Confirming that the patient has removed the wearable defibrillator based on the at least one electrical signal and the at least one motion signal; and Record the aforementioned completion event. including, A wearable defibrillator according to claim 24.

26. Determining the current time includes determining, based on the current time, whether the patient has been in an active or inactive state. The wearable defibrillator according to claim 7.

27. The at least one processor is further configured to record at least one of the insertion start event and the insertion end event based on the at least one electrical signal if the patient has been inactive up to the present time. The wearable defibrillator according to claim 26.

28. The at least one processor is further configured to record at least one of the attachment start event and the attachment end event based on the at least one electrical signal and the at least one motion signal, if the patient has been active at the present time. The wearable defibrillator according to claim 26.

29. The at least one processor is further configured to determine whether the patient has been active or inactive based on the current time and past patient activity information recorded by the wearable defibrillator. The wearable defibrillator according to claim 26.

30. The aforementioned graphic representation includes an indication of patient compliance in contrast to patient non-compliance. A wearable defibrillator according to any one of claims 1 to 29.

31. The graphic representation includes an indication of recorded changes in the patient's wear compliance. A wearable defibrillator according to any one of claims 1 to 29.

32. The graphic representation includes a timeline showing the recorded start and end events of the fitting process. A wearable defibrillator according to any one of claims 1 to 29.

33. The timeline further shows the total time the wearable defibrillator was worn by the patient and the total time the wearable defibrillator was not worn by the patient, over a user-selectable period. The wearable defibrillator according to claim 32.

34. The graphic representation includes one or more user-selectable interface controls configured to provide access to recorded ECG information for one or more of the following: the start event of wearing the device, the end event of wearing the device, and the period during which the patient wore the wearable defibrillator. A wearable defibrillator according to any one of claims 1 to 29.

35. The at least one processor is further configured to output a notification of the patient's compliance with the device's fitting. A wearable defibrillator according to any one of claims 1 to 7.

36. Outputting the notification regarding the patient's compliance with the fitting means Comparing the patient's compliance with the fitting criteria to one or more notification criteria; and If the patient's compliance with the fitting meets at least one of the one or more notification criteria, the notification shall be output. including, A wearable defibrillator according to claim 35.

37. The at least one processor is further configured to output the notification of the patient's wearing compliance to one or more of the patient, the caregiver associated with the patient, or the prescriber of the wearable defibrillator. A wearable defibrillator according to claim 35.

38. A method for providing wear compliance information recorded by a wearable defibrillator worn by a patient, A step in which at least one processor receives at least one electrical signal, determined based on monitored electrical activity on the patient's skin, from a plurality of electrodes operably coupled to the at least one processor; A step in which the at least one processor receives at least one motion signal based on the patient's movement and generated by at least one motion sensor and associated circuitry operably coupled to the at least one processor; A step in which the at least one processor records a wear-in event based on one or more of the at least one electrical signal or the at least one motion signal indicating that the patient is wearing the wearable defibrillator; A step in which the at least one processor records an end-of-wear event based on one or more of the at least one electrical signal and the at least one motion signal indicating that the patient is not wearing the wearable defibrillator; The step of the at least one processor providing a graphical representation of the patient's fitting compliance based on the recorded fitting start event and the recorded fitting end event; The step of at least one processor receiving notification criteria from one or more of the patient's care providers or the prescribers of the wearable defibrillator; The step of the at least one processor comparing the patient's wear compliance with the one or more notification criteria; and If the patient's compliance with wearing the device meets at least one of the one or more notification criteria, the at least one processor outputs a notification to one or more of the patient, the patient's caregiver, or the prescriber of the wearable defibrillator. Equipped with, The step of recording the aforementioned mounting start event is: The step of the at least one processor detecting one or more ECG signals based on the at least one electrical signal; The step of at least one processor determining whether the one or more ECG signals satisfy one or more validity criteria; and If the one or more ECG signals satisfy at least one of the one or more validity criteria, the at least one processor records the wear start event. It has, The step of recording the aforementioned completion event is: The step of the at least one processor determining whether the impedance level is no longer within an acceptable impedance range; and The step of at least one processor recording the end-of-installation event based on the determination that the impedance level is no longer within the acceptable impedance range. It has, The one or more effectiveness criteria include at least one ECG parameter derived from the one or more ECG signals that satisfy the effectiveness threshold. The at least one ECG parameter includes an R-peak amplitude, and satisfying the validity threshold includes identifying at least five consecutive R-peak amplitudes, each exceeding the amplitude threshold. method.

39. A method for providing wear compliance information recorded by a wearable defibrillator worn by a patient, A step in which at least one processor receives at least one electrical signal, determined based on monitored electrical activity on the patient's skin, from a plurality of electrodes operably coupled to the at least one processor; A step in which the at least one processor receives at least one motion signal based on the patient's movement and generated by at least one motion sensor and associated circuitry operably coupled to the at least one processor; A step in which the at least one processor records a wear-in event based on one or more of the at least one electrical signal or the at least one motion signal indicating that the patient is wearing the wearable defibrillator; A step in which the at least one processor records an end-of-wear event based on one or more of the at least one electrical signal and the at least one motion signal indicating that the patient is not wearing the wearable defibrillator; The step of the at least one processor providing a graphical representation of the patient's fitting compliance based on the recorded fitting start event and the recorded fitting end event; The step of at least one processor receiving notification criteria from one or more of the patient's care providers or the prescribers of the wearable defibrillator; The step of the at least one processor comparing the patient's wear compliance with the one or more notification criteria; and If the patient's compliance with wearing the device meets at least one of the one or more notification criteria, the at least one processor outputs a notification to one or more of the patient, the patient's caregiver, or the prescriber of the wearable defibrillator. Equipped with, The step of recording the aforementioned mounting start event is: The step of the at least one processor detecting one or more ECG signals based on the at least one electrical signal; The step of at least one processor determining whether the one or more ECG signals satisfy one or more validity criteria; and If the one or more ECG signals satisfy at least one of the one or more validity criteria, the at least one processor records the wear start event. It has, The step of recording the aforementioned completion event is: The step of the at least one processor determining whether the impedance level is no longer within an acceptable impedance range; and The step of at least one processor recording the end-of-installation event based on the determination that the impedance level is no longer within the acceptable impedance range. It has, The one or more effectiveness criteria include at least one ECG parameter derived from the one or more ECG signals that satisfy the effectiveness threshold. The at least one ECG parameter includes a QRS composite width, and satisfying the validity threshold includes measuring at least five consecutive QRS composite widths, each between 0.05 seconds and 0.15 seconds. method.

40. A method for providing wearing compliance information recorded by a wearable defibrillator worn by a patient, A step in which at least one processor receives at least one electrical signal, determined based on monitored electrical activity on the patient's skin, from a plurality of electrodes operably coupled to the at least one processor; A step in which the at least one processor receives at least one motion signal based on the patient's movement and generated by at least one motion sensor and associated circuitry operably coupled to the at least one processor; A step in which the at least one processor records a wear-in event based on one or more of the at least one electrical signal or the at least one motion signal indicating that the patient is wearing the wearable defibrillator; A step in which the at least one processor records an end-of-wear event based on one or more of the at least one electrical signal and the at least one motion signal indicating that the patient is not wearing the wearable defibrillator; The step of the at least one processor providing a graphical representation of the patient's fitting compliance based on the recorded fitting start event and the recorded fitting end event; The step of at least one processor receiving notification criteria from one or more of the patient's care providers or the prescribers of the wearable defibrillator; The step of the at least one processor comparing the patient's wear compliance with the one or more notification criteria; and If the patient's compliance with wearing the device meets at least one of the one or more notification criteria, the at least one processor outputs a notification to one or more of the patient, the patient's caregiver, or the prescriber of the wearable defibrillator. Equipped with, The step of recording the aforementioned mounting start event is: The step of at least one processor determining whether the motion signal indicates the movement of the patient and the wearable defibrillator; and If the motion signal indicates movement of the patient and the wearable defibrillator, the at least one processor records the wear-in event. Includes, The aforementioned method, The steps include: the at least one processor detecting one or more ECG signals based on the at least one electrical signal if the motion signal does not indicate the movement of the patient and the wearable defibrillator; and The step in which at least one processor records the installation start event based on an analysis of the one or more ECG signals. Methods to further prepare.

41. A method for providing wearing compliance information recorded by a wearable defibrillator worn by a patient, A step in which at least one processor receives at least one electrical signal, determined based on monitored electrical activity on the patient's skin, from a plurality of electrodes operably coupled to the at least one processor; A step in which the at least one processor receives at least one motion signal based on the patient's movement and generated by at least one motion sensor and associated circuitry operably coupled to the at least one processor; A step in which the at least one processor records a wear-in event based on one or more of the at least one electrical signal or the at least one motion signal indicating that the patient is wearing the wearable defibrillator; A step in which the at least one processor records an end-of-wear event based on one or more of the at least one electrical signal and the at least one motion signal indicating that the patient is not wearing the wearable defibrillator; The step of the at least one processor providing a graphical representation of the patient's fitting compliance based on the recorded fitting start event and the recorded fitting end event; The step of at least one processor receiving notification criteria from one or more of the patient's care providers or the prescribers of the wearable defibrillator; The step of the at least one processor comparing the patient's wear compliance with the one or more notification criteria; and If the patient's compliance with wearing the device meets at least one of the one or more notification criteria, the at least one processor outputs a notification to one or more of the patient, the patient's caregiver, or the prescriber of the wearable defibrillator. Equipped with, The step of recording the aforementioned completion event is: The step of the at least one processor detecting a change in the at least one electrical signal indicating an invalid ECG signal; and The step in which at least one processor records the installation completion event based on the invalid ECG signal. including, method.

42. A method for providing wearing compliance information recorded by a wearable defibrillator worn by a patient, A step in which at least one processor receives at least one electrical signal, determined based on monitored electrical activity on the patient's skin, from a plurality of electrodes operably coupled to the at least one processor; A step in which the at least one processor receives at least one motion signal based on the patient's movement and generated by at least one motion sensor and associated circuitry operably coupled to the at least one processor; A step in which the at least one processor records a wear-in event based on one or more of the at least one electrical signal or the at least one motion signal indicating that the patient is wearing the wearable defibrillator; A step in which the at least one processor records an end-of-wear event based on one or more of the at least one electrical signal and the at least one motion signal indicating that the patient is not wearing the wearable defibrillator; The step of the at least one processor providing a graphical representation of the patient's fitting compliance based on the recorded fitting start event and the recorded fitting end event; The step of at least one processor receiving notification criteria from one or more of the patient's care providers or the prescribers of the wearable defibrillator; The step of the at least one processor comparing the patient's wear compliance with the one or more notification criteria; and If the patient's compliance with wearing the device meets at least one of the one or more notification criteria, the at least one processor outputs a notification to one or more of the patient, the patient's caregiver, or the prescriber of the wearable defibrillator. Equipped with, The step of recording the aforementioned completion event is: The step of determining that at least one processor determines that one or more of the plurality of electrodes, and at least one motion sensor and associated circuitry are disconnected from the wearable defibrillator; and If it is determined that one or more of the plurality of electrodes, and at least one motion sensor and associated circuit are disconnected, the at least one processor records the attachment completion event. including, method.

43. A method for providing wear compliance information recorded by a wearable defibrillator worn by a patient, A step in which at least one processor receives at least one electrical signal, determined based on monitored electrical activity on the patient's skin, from a plurality of electrodes operably coupled to the at least one processor; A step in which the at least one processor receives at least one motion signal based on the patient's movement and generated by at least one motion sensor and associated circuitry operably coupled to the at least one processor; A step in which the at least one processor records a wear-in event based on one or more of the at least one electrical signal or the at least one motion signal indicating that the patient is wearing the wearable defibrillator; A step in which the at least one processor records an end-of-wear event based on one or more of the at least one electrical signal and the at least one motion signal indicating that the patient is not wearing the wearable defibrillator; The step of the at least one processor providing a graphical representation of the patient's fitting compliance based on the recorded fitting start event and the recorded fitting end event; The step of at least one processor receiving notification criteria from one or more of the patient's care providers or the prescribers of the wearable defibrillator; The step of the at least one processor comparing the patient's wear compliance with the one or more notification criteria; and If the patient's compliance with wearing the device meets at least one of the one or more notification criteria, the at least one processor outputs a notification to one or more of the patient, the patient's caregiver, or the prescriber of the wearable defibrillator. Equipped with, The step of recording the aforementioned completion event is: The step of the at least one processor detecting, based on an analysis of the at least one motion signal, that the patient has removed the wearable defibrillator; The step of the at least one processor confirming that the at least one electrical signal indicates that the patient has removed the wearable defibrillator; and The step in which at least one processor records the end-of-wear event based on confirmation that the patient has removed the wearable defibrillator. including, method.

44. A method for providing wearing compliance information recorded by a wearable defibrillator worn by a patient, A step in which at least one processor receives at least one electrical signal, determined based on monitored electrical activity on the patient's skin, from a plurality of electrodes operably coupled to the at least one processor; A step in which the at least one processor receives at least one motion signal based on the patient's movement and generated by at least one motion sensor and associated circuitry operably coupled to the at least one processor; A step in which the at least one processor records a wear-in event based on one or more of the at least one electrical signal or the at least one motion signal indicating that the patient is wearing the wearable defibrillator; A step in which the at least one processor records an end-of-wear event based on one or more of the at least one electrical signal and the at least one motion signal indicating that the patient is not wearing the wearable defibrillator; The step of the at least one processor providing a graphical representation of the patient's fitting compliance based on the recorded fitting start event and the recorded fitting end event; The step of at least one processor receiving notification criteria from one or more of the patient's care providers or the prescribers of the wearable defibrillator; The step in which at least one processor compares the patient's wear compliance with the one or more notification criteria; If the patient's compliance with wearing the device meets at least one of the one or more notification criteria, the at least one processor outputs a notification to one or more of the patient, the patient's caregiver, or the prescriber of the wearable defibrillator; The step of at least one processor determining the current time; and The step in which the at least one processor records at least one of the mounting start event and the mounting end event based on one or more of the at least one motion signal, the at least one electrical signal, or the current time. A method that includes [a certain feature].

45. A method for providing wear compliance information recorded by a wearable defibrillator worn by a patient, A step in which at least one processor receives at least one electrical signal, determined based on monitored electrical activity on the patient's skin, from a plurality of electrodes operably coupled to the at least one processor; A step in which the at least one processor receives at least one motion signal based on the patient's movement and generated by at least one motion sensor and associated circuitry operably coupled to the at least one processor; A step in which the at least one processor records a wear-in event based on one or more of the at least one electrical signal or the at least one motion signal indicating that the patient is wearing the wearable defibrillator; A step in which the at least one processor records an end-of-wear event based on one or more of the at least one electrical signal and the at least one motion signal indicating that the patient is not wearing the wearable defibrillator; The step of the at least one processor providing a graphical representation of the patient's fitting compliance based on the recorded fitting start event and the recorded fitting end event; The step of at least one processor receiving notification criteria from one or more of the patient's care providers or the prescribers of the wearable defibrillator; The step of the at least one processor comparing the patient's wear compliance with the one or more notification criteria; and If the patient's compliance with wearing the device meets at least one of the one or more notification criteria, the at least one processor outputs a notification to one or more of the patient, the patient's caregiver, or the prescriber of the wearable defibrillator. Equipped with, The step of outputting the aforementioned notification is: The step of at least one processor comparing the patient's wear compliance with the one or more notification criteria; and If the patient's compliance with the device meets at least one of the one or more notification criteria, the at least one processor outputs the notification. It has, The one or more notification criteria mentioned above include the patient failing to wear the wearable defibrillator over a certain percentage of the time over a certain period of time. method.

46. A method for providing wear compliance information recorded by a wearable defibrillator worn by a patient, A step in which at least one processor receives at least one electrical signal, determined based on monitored electrical activity on the patient's skin, from a plurality of electrodes operably coupled to the at least one processor; A step in which the at least one processor receives at least one motion signal based on the patient's movement and generated by at least one motion sensor and associated circuitry operably coupled to the at least one processor; A step in which the at least one processor records a wear-in event based on one or more of the at least one electrical signal or the at least one motion signal indicating that the patient is wearing the wearable defibrillator; A step in which the at least one processor records an end-of-wear event based on one or more of the at least one electrical signal and the at least one motion signal indicating that the patient is not wearing the wearable defibrillator; The step of the at least one processor providing a graphical representation of the patient's fitting compliance based on the recorded fitting start event and the recorded fitting end event; The step of at least one processor receiving notification criteria from one or more of the patient's care providers or the prescribers of the wearable defibrillator; The step of the at least one processor comparing the patient's wear compliance with the one or more notification criteria; and If the patient's compliance with wearing the device meets at least one of the one or more notification criteria, the at least one processor outputs a notification to one or more of the patient, the patient's caregiver, or the prescriber of the wearable defibrillator. Equipped with, The step of outputting the aforementioned notification is: The step of at least one processor comparing the patient's wear compliance with the one or more notification criteria; and If the patient's compliance with the device meets at least one of the one or more notification criteria, the at least one processor outputs the notification. It has, The one or more notification criteria include a recorded change in the patient's wear compliance that exceeds a compliance change threshold. method.

47. The at least one processor further comprises the step of outputting the graphic representation to a display operably coupled to the at least one processor. The method according to any one of claims 38 to 46.

48. The step further comprises the at least one processor transmitting information regarding the patient's fitting compliance via a network interface to a remote server operably coupled to the at least one processor. The method according to any one of claims 38 to 46.

49. The step of recording the aforementioned mounting start event is: The step of the at least one processor detecting one or more ECG signals based on the at least one electrical signal; The step of at least one processor determining whether the one or more ECG signals satisfy one or more validity criteria; and If the one or more ECG signals satisfy at least one of the one or more validity criteria, the at least one processor records the wear start event. It has, The step of recording the aforementioned completion event is: The step of the at least one processor determining whether the impedance level is no longer within an acceptable impedance range; and The step of at least one processor recording the end-of-installation event based on the determination that the impedance level is no longer within the acceptable impedance range. has The method according to claim 45 or 46.

50. The one or more effectiveness criteria include at least one ECG parameter derived from the one or more ECG signals that satisfy the effectiveness threshold. The method according to claim 49.

51. The at least one processor further comprises a step of determining the patient's fit compliance based on a first ECG signal of the one or more ECG signals that satisfy the effectiveness threshold. The method according to claim 50.

52. Recording the aforementioned mounting start event means To detect the impedance level of the skin-sensor interface in one or more of the aforementioned electrodes; Determining whether the impedance level is within an acceptable impedance range; and If the impedance level is within the acceptable impedance range, record the wear start event. including, The method according to any one of claims 41, 42, 43, 45, and 46.

53. The acceptable impedance range includes at least one of the ranges from 20 ohms to 250 ohms, from 250 ohms to 1 kilohm, and from 1 kilohm to 20 kilohms. The method according to claim 52.

54. The step of recording the aforementioned mounting start event is: The step of at least one processor determining whether the motion signal indicates the movement of the patient and the wearable defibrillator; and If the motion signal indicates movement of the patient and the wearable defibrillator, the at least one processor records the wear-in event. including, The method according to any one of claims 41, 42, 43, 45, and 46.

55. The step of the at least one processor detecting one or more noise components in the at least one electrical signal; and The step in which at least one processor confirms that there is no movement of the patient based on an analysis of the one or more noise components in at least one electrical signal. The method according to claim 40, further comprising:

56. The step of recording the aforementioned mounting start event is: A step in which at least one processor receives input from the patient indicating that the patient is wearing the wearable defibrillator; and The step in which at least one processor records the insertion start event based on the input from the patient. Having, The method according to any one of claims 41, 42, 43, 45, and 46.

57. The step of recording the insertion start event based on the input from the patient is: The step of the at least one processor confirming, based on the at least one electrical signal and the at least one motion signal, that the patient is wearing the wearable defibrillator; and The step in which at least one processor records the installation start event. including, The method according to claim 56.

58. The step of recording the aforementioned completion event is: A step in which at least one processor detects a change in the impedance level of the skin-sensor interface at one or more of the plurality of electrodes; The step of the at least one processor determining whether the impedance level exceeds an impedance threshold; and If the impedance level exceeds the impedance threshold, at least one processor records the installation completion event. including, The method according to any one of claims 40, 45, and 46.

59. The impedance threshold includes one or more of 10 kilohms, 100 kilohms, 1 megahm, 2 megahms, 5 megahms, or 10 megahms. The method according to claim 58.

60. The step of recording the aforementioned completion event is: A step in which at least one processor receives input from the patient indicating that the patient has removed the wearable defibrillator; and The step in which at least one processor records the end-of-wearing event based on the input from the patient. Having, The method according to any one of claims 40, 45, and 46.

61. The step of recording the end-of-wearing event based on the input from the patient is: A step in which the at least one processor confirms, based on the at least one electrical signal and the at least one motion signal, that the patient has removed the wearable defibrillator; and The step in which at least one processor records the installation completion event. including, The method according to claim 60.

62. The step of determining the current time includes the step of at least one processor determining, based on the current time, whether the patient has been in an active state or an inactive state. The method according to claim 44.

63. If the patient has been inactive up to the present time, the at least one processor further comprises the step of recording at least one of the insertion start event and the insertion end event based on the at least one electrical signal. The method according to claim 62.

64. If the patient has been active up to the present time, the at least one processor further comprises the step of recording at least one of the attachment start event and the attachment end event based on the at least one electrical signal and the at least one motion signal. The method according to claim 62.

65. The at least one processor further comprises a step of determining whether the patient has been active or inactive based on the current time and past patient activity information recorded by the wearable defibrillator. The method according to claim 62.

66. The aforementioned notice includes indications of patient-wear compliance for patient-wear non-compliance, The method according to any one of claims 38 to 44.

67. The aforementioned notification includes indication of recorded changes in the patient's compliance with the device, The method according to any one of claims 38 to 44.

68. The notification includes a timeline showing the recorded start and end events of the fitting process. The method according to any one of claims 38 to 44.

69. The timeline further shows the total time the wearable defibrillator was worn by the patient and the total time the wearable defibrillator was not worn by the patient, over a user-selectable period. The method according to claim 68.

70. The notification includes one or more user-selectable interface controls configured to provide access to recorded ECG information for one or more of the following: a start event, a stop event, or the period during which the patient wore the wearable defibrillator. The method according to any one of claims 38 to 44.

71. The step of outputting the notification is: The step of at least one processor comparing the patient's wear compliance with the one or more notification criteria; and If the patient's compliance with the device meets at least one of the one or more notification criteria, the at least one processor outputs the notification. Having, The method according to any one of claims 38 to 44.

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