Wearable cardiac medical device, control method, and medical system

Abstract

The application provides a wearable cardiac medical device, a control method and a medical system, the device comprising: a plurality of conductive electrodes; a controller connected to the plurality of conductive electrodes, the controller being configured to acquire cardiac monitoring data of a patient through the conductive electrodes in a cardiac monitoring mode, determine whether to enter a cardiac treatment mode according to the cardiac monitoring data, and deliver treatment to the patient through the conductive electrodes in the cardiac treatment mode. The application makes the cardiac monitoring and treatment share a set of conductive electrodes, simplifies the structure of the wearable cardiac medical device, reduces the failure rate, and improves the comfort and compliance of the patient wearing.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, specifically to a wearable cardiac medical device, control method, and medical system. Background Technology

[0002] A wearable cardioverter defibrillator (WCD) is a wearable, external automated defibrillator that allows the patient to deliver shocks independently without bystander intervention. A conscious patient can delay or terminate treatment by pressing a response button. The WCD is used by the patient outside the hospital, with a wear period ranging from 3 days to 6 months. While the WCD is operational, the ECG electrodes provide 24-hour ECG monitoring. Once the WCD detects VF / VT (ventricular fibrillation or ventricular tachycardia) and confirms the patient is unresponsive, it switches to defibrillation mode. Conductive gel is sprayed from the defibrillation electrode pads, initiating defibrillation.

[0003] In traditional wearable automated external defibrillators (AEDs), the ECG acquisition device and the defibrillator use two independent sets of electrodes. The complex structure of wearable AEDs, with numerous connections between leads and electrodes, makes them prone to poor contact and wire breakage, resulting in a high failure rate. Furthermore, the complexity requires fixing two sets of electrodes on the wearable device, with multiple electrodes per set, leading to patient discomfort, reduced patient compliance, and hindering long-term, continuous use. During periods when the device is not in use, the risk of sudden cardiac death increases.

[0004] It should be noted that the information disclosed in the background section above is only used to enhance the understanding of the background of the present invention, and therefore may include information that does not constitute prior art known to those skilled in the art. Summary of the Invention

[0005] To address the problems in the prior art, the present invention aims to provide a wearable cardiac medical device, control method, and medical system in which a single set of conductive electrodes is used for both electrocardiogram (ECG) acquisition and treatment, simplifying the structure of the wearable cardiac medical device, reducing the failure rate, and improving patient comfort and compliance.

[0006] This invention provides a wearable cardiac medical device, comprising:

[0007] Multiple conductive electrodes;

[0008] A controller is connected to the plurality of conductive electrodes. The controller is used to collect the patient's cardiac monitoring data through the conductive electrodes in cardiac monitoring mode, determine whether to enter cardiac treatment mode based on the cardiac monitoring data, and deliver treatment to the patient through the conductive electrodes in cardiac treatment mode.

[0009] In some embodiments, in cardiac monitoring mode, the controller is configured to acquire potential values ​​from the conductive electrodes, obtain the patient's electrocardiogram (ECG) signal based on the potential difference between any two non-conductive conductive electrodes, and generate the cardiac monitoring data based on the ECG signal.

[0010] In some embodiments, N conductive electrodes are included, and the controller generates the cardiac monitoring data based on the electrocardiogram signal, including... The ECG signals from each signal channel are evaluated for signal quality. ECG signals that meet the preset quality requirements are selected for cardiac index analysis to generate the cardiac monitoring data.

[0011] In some embodiments, the plurality of conductive electrodes includes a first group of conductive electrodes and a second group of conductive electrodes, wherein the first group of conductive electrodes includes at least one conductive electrode and the second group of conductive electrodes includes at least one conductive electrode; in cardiac treatment mode, the controller controls all conductive electrodes in the first group of conductive electrodes to be interconnected as positive electrodes, controls all conductive electrodes in the second group of conductive electrodes to be interconnected as negative electrodes, and discharges the patient through the first group of conductive electrodes and the second group of conductive electrodes.

[0012] In some embodiments, at least one first control switch is provided in the first group of conductive electrodes, and at least one second control switch is provided in the second group of conductive electrodes;

[0013] The controller is used to open the first control switch and the second control switch in the ECG monitoring mode so that there is no conduction between all conductive electrodes, and to close the first control switch and the second control switch in the cardiac treatment mode so that the first group of conductive electrodes and the second group of conductive electrodes are connected to each other.

[0014] In some embodiments, a first control switch is provided between any two conductive electrodes in the first group of conductive electrodes, and a second control switch is provided between any two conductive electrodes in the second group of conductive electrodes.

[0015] In some embodiments, a glue spraying device is also included, and in cardiac treatment mode, the controller is further configured to activate the glue spraying device to spray glue onto the conductive electrodes.

[0016] In some embodiments, an energy storage capacitor is also included, and the controller is further configured to charge the energy storage capacitor during cardiac treatment mode.

[0017] In some embodiments, one set of the first set of conductive electrodes and the second set of conductive electrodes is disposed on the patient's chest, and the other set is disposed on the patient's back.

[0018] In some embodiments, both the first group of conductive electrodes and the second group of conductive electrodes are disposed on the patient's chest, and the first group of conductive electrodes and the second group of conductive electrodes are arranged diagonally.

[0019] In some embodiments, a motion sensor is also included, and the controller is further configured to acquire the patient's motion data from the motion sensor and determine whether to enter a cardiac treatment mode based on the cardiac monitoring data and the motion data.

[0020] In some embodiments, a data communication device is also included for transmitting the cardiac monitoring data to an external device, the data communication device including a wired communication device and / or a wireless communication device.

[0021] In some embodiments, a display device is further included, connected to the controller, for displaying at least one of patient information, cardiac monitoring data, device status data, and electrode status data, and / or receiving at least one of user-set treatment control parameters, device operating status control commands, and electrode operating status control commands.

[0022] This invention also provides a control method for a wearable cardiac medical device, using the aforementioned wearable cardiac medical device, the method comprising the following steps:

[0023] The controller collects cardiac monitoring data from the patient via the conductive electrodes;

[0024] The controller determines whether treatment is needed based on the cardiac monitoring data.

[0025] If treatment is required, the controller delivers the treatment to the patient via the conductive electrodes.

[0026] In some embodiments, the controller acquires cardiac monitoring data of the patient through the conductive electrodes, including the following steps:

[0027] The controller obtains the potential value from the conductive electrode;

[0028] The controller obtains the patient's electrocardiogram (ECG) signal based on the potential difference between any two non-conductive conductive electrodes, and generates the cardiac monitoring data based on the ECG signal.

[0029] In some embodiments, the plurality of conductive electrodes includes a first group of conductive electrodes and a second group of conductive electrodes, and the medical device further includes a spray adhesive device and an energy storage capacitor;

[0030] The controller delivers treatment to the patient via the conductive electrodes, including the following steps:

[0031] The controller activates the adhesive spraying device to spray adhesive onto the conductive electrodes;

[0032] The controller charges the energy storage capacitor;

[0033] The controller controls the first group of conductive electrodes to conduct to each other as positive electrodes, and the second group of conductive electrodes to conduct to each other as negative electrodes;

[0034] The controller controls the energy storage capacitor to discharge to the conductive electrode, and delivers the treatment to the patient through the conductive electrode.

[0035] In some embodiments, after the controller delivers treatment to the patient via the conductive electrodes, the method further includes the following steps:

[0036] The controller controls the disconnection between the first group of conductive electrodes and the disconnection between the second group of conductive electrodes.

[0037] The controller continues to collect cardiac monitoring data from the patient via the conductive electrodes.

[0038] In some embodiments, the medical device further includes a motion sensor;

[0039] The controller determines whether treatment is needed based on the cardiac monitoring data, including the following steps:

[0040] The controller acquires motion data from the motion sensor;

[0041] The controller determines whether treatment is needed based on the cardiac monitoring data and the motion data.

[0042] This invention also provides a medical system, comprising:

[0043] The wearable cardiac medical device includes a data communication device.

[0044] An external device is used to acquire and store cardiac monitoring data from the data communication device of the wearable cardiac medical device.

[0045] In some embodiments, the external device is further configured to analyze the cardiac monitoring data using a preset dynamic analysis algorithm to obtain dynamic analysis indicators and generate a dynamic analysis report within a first time range.

[0046] In some embodiments, the external device is further configured to perform analysis based on the dynamic analysis indicators using a preset trend analysis algorithm, obtain trend analysis indicators, and generate a trend analysis report within a second time range, wherein the second time range is greater than the first time range.

[0047] In some embodiments, the external device is further configured to extract risk assessment features based on one or more of the patient information, the cardiac monitoring data, the dynamic analysis indicators, and the trend analysis indicators, and input the risk assessment features into a trained sudden cardiac death risk assessment model to obtain a sudden cardiac death risk assessment value.

[0048] In some embodiments, the external device is further used to collect multiple training samples, construct a training sample set, add risk assessment value labels to the training samples, and train the sudden cardiac death risk assessment model based on the training sample set and the corresponding risk assessment value labels.

[0049] The wearable cardiac medical device, control method, and medical system provided by this invention have the following advantages:

[0050] This invention simplifies the structure of wearable cardiac medical devices by using a single set of conductive electrodes for both ECG acquisition and defibrillation. It reduces the number of connection points between the wires and the conductive electrodes, thereby reducing the probability of poor contact or disconnection at the connection points and thus lowering the failure rate of the medical device. At the same time, it can reduce the overall number of electrodes, making it more convenient to wear and use, and improving patient comfort and compliance. Attached Figure Description

[0051] Other features, objects, and advantages of the invention will become more apparent from the following detailed description of non-limiting embodiments with reference to the accompanying drawings.

[0052] Figure 1 This is a structural block diagram of a wearable cardiac medical device according to an embodiment of the present invention;

[0053] Figure 2 This is a schematic diagram of the connection between the conductive electrode and the controller according to an embodiment of the present invention;

[0054] Figure 3 This is a structural block diagram of a wearable cardiac medical device according to a specific embodiment of the present invention;

[0055] Figure 4 This is a flowchart of a control method for a wearable cardiac medical device according to an embodiment of the present invention;

[0056] Figure 5 This is a flowchart of a medical device delivering treatment according to an embodiment of the present invention;

[0057] Figure 6 This is a structural block diagram of a medical system according to an embodiment of the present invention. Detailed Implementation

[0058] Exemplary embodiments will now be described more fully with reference to the accompanying drawings. However, these exemplary embodiments can be implemented in many forms and should not be construed as limited to the embodiments set forth herein; rather, they are provided so that the invention will be thorough and complete, and will fully convey the concept of the exemplary embodiments to those skilled in the art. The same reference numerals in the drawings denote the same or similar structures, and therefore repeated descriptions of them will be omitted. The words “or” and “or” in the specification may mean “and” or “or”. Nothing in this specification should be construed as requiring a specific three-dimensional orientation of the structure to fall within the scope of the invention. Although “first” or “second”, etc., are used in this specification to indicate certain features, they are only for indicating function and do not represent limitations on the number and importance of specific features.

[0059] like Figure 1As shown, the wearable cardiac medical device includes a wearable garment M100 and a device host M200. This embodiment uses a wearable defibrillator as an example. Patients with a high risk of sudden cardiac death generally need to wear this wearable defibrillator. The wearable cardiac medical device includes a wearable garment M100 and a device host M200. The wearable garment M100 can be, for example, a wearable vest, a shoulder strap, etc., used to place the conductive electrodes M110 around the patient's heart. The wearable garment M100 has N conductive electrodes M110, where N≥2, and the conductive electrodes M110 are attached to the patient's body surface during use. The device host M200 includes a housing and a controller M210 located inside the housing. The controller M210 is connected to each of the conductive electrodes M110 via wires M300. The controller M210 includes a data acquisition unit M211, a data processing unit M212, and a treatment control unit M213. The data acquisition unit M211 is used to acquire the patient's cardiac monitoring data through the conductive electrode M110 in cardiac monitoring mode. The data processing unit M212 is used to determine whether to enter cardiac treatment mode based on the cardiac monitoring data. For example, it performs arrhythmia analysis based on the cardiac monitoring data. If VF / VT is found, it is determined that cardiac treatment mode needs to be entered, i.e., treatment is initiated. The treatment control unit M213 is used to deliver treatment to the patient through the conductive electrode M110 in cardiac treatment mode, i.e., to deliver a defibrillation shock to the patient. Therefore, the conductive electrode M110 can be used as a cardiac monitoring electrode in cardiac monitoring mode and as a cardiac treatment electrode in cardiac treatment mode. This invention simplifies the structure of wearable cardiac medical devices by sharing a set of conductive electrodes for ECG acquisition and defibrillation, reduces the number of connection points between the lead M300 and the conductive electrode M110, reduces the probability of poor contact or disconnection at the connection points, thereby reducing the failure rate of the medical device. At the same time, it can reduce the overall number of electrodes, making it more convenient to wear and use, and improving patient comfort and compliance.

[0060] like Figure 2As shown, in this embodiment, the plurality of conductive electrodes includes a first group of conductive electrodes M111 and a second group of conductive electrodes M112. The first group of conductive electrodes M111 includes N1 conductive electrodes, and the second group of conductive electrodes M112 includes N2 conductive electrodes, where N1≥1, N2≥1, and N=N1+N2. When the first group of conductive electrodes M111 includes one conductive electrode and the second group of conductive electrodes M112 includes one conductive electrode, switching from cardiac monitoring mode to cardiac treatment mode can be achieved simply by spraying adhesive and discharging it onto the conductive electrodes. When the first group of conductive electrodes M111 includes at least two conductive electrodes and the second group of conductive electrodes M112 includes at least two conductive electrodes, an additional control switch is required to control the on / off state between the conductive electrodes in the same group. Figure 2 The following description uses the first group of conductive electrodes M111, comprising three conductive electrodes: conductive electrode 11, conductive electrode 12, and conductive electrode 13, and the second group of conductive electrodes M12, comprising three conductive electrodes: conductive electrode 21, conductive electrode 22, and conductive electrode 23, as examples. The controller M210 is connected to each conductive electrode via wires M300. In the first group of conductive electrodes M111, a first control switch K1 is provided between every two conductive electrodes; in the second group of conductive electrodes M112, a second control switch K2 is provided between every two conductive electrodes. The controller M210 controls the first control switch K1 and the second control switch K2 according to different operating modes. When both the first control switch K1 and the second control switch K2 are open, all conductive electrodes are not conductive to each other, which allows for the acquisition of cardiac monitoring data in cardiac monitoring mode. When both the first control switch K1 and the second control switch K2 are closed, all conductive electrodes 11 to 13 in the first group of conductive electrodes M111 are interconnected as positive electrodes, and all conductive electrodes 21 to 23 in the second group of conductive electrodes M112 are interconnected as negative electrodes, which can be used to deliver treatment to the patient in cardiac treatment mode.

[0061] Specifically, in cardiac monitoring mode, the controller M210 controls both the first control switch K1 and the second control switch K2 to be disconnected. The controller M210 acquires potential values ​​from the conductive electrodes and obtains the patient's electrocardiogram (ECG) signal based on the potential difference between any two non-conductive conductive electrodes. Based on the ECG signal, cardiac monitoring data is generated. The cardiac monitoring data may include, for example, the ECG signal itself, an electrocardiogram (ECG) obtained from the ECG signal, and data such as heart rate and ECG waveform calculated from the ECG signal. With N conductive electrodes, the number of signal channels that can be acquired is... The data processing unit M212, based on the collected data The data processing unit M212 first analyzes the electrocardiogram (ECG) signals from each channel in real time, performing cardiac parameter analysis, including heart rate values, etc. Specifically, the data processing unit M212 first... The signal quality of each channel is evaluated. Based on the evaluation results, the signal from the channel with better quality (i.e., the signal quality meets the preset quality requirements) is selected. The patient's heart rate is then calculated, and arrhythmia analysis is performed. The preset quality requirements may include, for example, requirements for delay time and signal jitter.

[0062] In cardiac treatment mode, the controller M210 controls each of the first control switches K1 to close, making all conductive electrodes in the first group of conductive electrodes M111 interconnected as positive terminals. The controller M210 also controls each of the second control switches K2 to close, making all conductive electrodes in the second group of conductive electrodes M112 interconnected as negative terminals. The controller M210 then delivers electrical discharge therapy to the patient through the first group of conductive electrodes M111 and the second group of conductive electrodes M112. After the wearable garment M100 is put on the patient, the first group of conductive electrodes M111 is positioned on the patient's chest, and the second group of conductive electrodes M112 is positioned on the patient's back; alternatively, the second group of conductive electrodes M112 is positioned on the patient's chest, and the first group of conductive electrodes M111 is positioned on the patient's back, ensuring that the current passes through the heart during the electrical discharge therapy. In another embodiment, both the first set of conductive electrodes M111 and the second set of conductive electrodes M112 can be placed on the patient's chest, and the first set of conductive electrodes M111 and the second set of conductive electrodes M112 can be arranged diagonally. For example, one set of conductive electrodes can be placed on the upper left side of the patient's chest cavity, and the other set of conductive electrodes can be placed on the lower right side of the patient's chest cavity, so as to ensure that the current passes through the heart during the discharge therapy.

[0063] In other alternative embodiments, the number of conductive electrodes in the first group of conductive electrodes M111 can be other values, for example, the first group of conductive electrodes M111 may include one, two, four, five, or more conductive electrodes. The number of conductive electrodes in the second group of conductive electrodes M112 can also be other values, for example, the second group of conductive electrodes M112 may include one, two, four, five, or more conductive electrodes. The number of conductive electrodes in the first group of conductive electrodes M111 and the second group of conductive electrodes M112 can be the same or different. A control switch can also be provided between the conductive electrodes in the first group of conductive electrodes M111 and the conductive electrodes in the second group of conductive electrodes M112, and the grouping of conductive electrodes can be adjusted by turning the control switch on and off.

[0064] In this embodiment, a first control switch K1 is disposed between any two conductive electrodes in the first group of conductive electrodes M111, and a second control switch K2 is disposed between any two conductive electrodes in the second group of conductive electrodes M112. In another alternative embodiment, the number of the first control switch K1 and the second control switch K2 can be reduced, for example, in... Figure 2 In the example, a first control switch K1 is provided only between conductive electrodes 11 and 12, and between conductive electrodes 12 and 13. This achieves the same purpose: when the first control switch K1 is closed, conductive electrodes 11, 12, and 13 are all conductive. Similarly, a second control switch K2 is provided only between conductive electrodes 21 and 22, and between conductive electrodes 22 and 23. This achieves the same purpose: when the second control switch K2 is closed, conductive electrodes 21, 22, and 23 are all conductive.

[0065] In another alternative implementation, in ECG monitoring mode, it is not necessarily required that all conductive electrodes be disconnected. For example, in Figure 2 In the example, in ECG monitoring mode, conductive electrodes 11 and 12 remain conductive, while other conductive electrodes are disconnected from each other. Therefore, the potential difference between conductive electrodes 11 and 12 is 0 and is not used as an ECG signal. Instead, the potential difference between any two non-conductive conductive electrodes is used as the patient's ECG signal.

[0066] like Figure 3 The diagram shown is a structural block diagram of a wearable cardiac medical device according to a specific example. In this specific example, the wearable garment M100 is further equipped with a motion sensor M120, which may include, for example, a gyroscope, vibration sensor, velocity sensor, accelerometer, etc., for detecting the patient's motion state. The data acquisition unit M211 is also used to acquire motion data from the motion sensor M120. When determining whether to enter the cardiac treatment mode, the data processing unit M212 judges the patient's motion state based on the motion data, that is, it makes a comprehensive judgment on whether to enter the cardiac treatment mode based on the cardiac monitoring data and the motion data, thereby reducing the incidence of false alarms and false defibrillation of shockable heart rate (VF / VT) during patient movement.

[0067] like Figure 3As shown, the device host M200 also includes a display device M220, a glue spraying device M230, a storage device M240, an alarm device M250, a response button M260, and a data communication device M270, all connected to the controller M210. The device host M200 also contains a battery M280 to power the various components within it. The display device M220 can be located on one side of the housing and is used for information interaction between the device host M200 and the patient / doctor. Specifically, the display device M220 displays at least one of patient information, cardiac monitoring data, device status data, and electrode status data, and / or receives at least one of user-set treatment control parameters, device operating status control commands, and electrode operating status control commands. Patient information includes, for example, the patient's name, age, and disease. Cardiac monitoring data includes, for example, electrocardiogram waveforms and heart rate values. Device status data includes, for example, the current operating status of the device and treatment control parameters. Device operating status includes, for example, device standby, device shutdown, and device treatment initiation. Electrode operating status includes, for example, electrode conduction and electrode disconnection. Electrode status data includes, for example, whether the electrode has detached, whether the electrode is malfunctioning, and the electrode's operating status. Treatment control parameters include, for example, the heart rate threshold for shockable heart rates and the amount of energy released during defibrillation. For example, the display device M220 displays patient information, the currently acquired ECG waveform, heart rate value, and information on whether the lead has detached. The doctor can also program the heart rate threshold for shockable heart rates and the amount of energy released during defibrillation through the display device M220. The display device M220 can be a touchscreen, or it can be a non-touchscreen display. An input keyboard is also provided for the user to set treatment control parameters, etc.

[0068] The adhesive spraying device M230 includes at least a device for storing conductive silicone and a device for spraying conductive silicone onto the surface of the conductive electrodes. The controller M210 can be implemented using a control chip and control circuit. The treatment control unit M213 includes at least a treatment control circuit, an adhesive spraying control switch, an energy storage capacitor, a charging control switch, and a discharging control switch. Taking cardiac treatment as defibrillation treatment as an example, when the data processing unit M212 determines that it is necessary to enter the cardiac treatment mode, that is, when treatment needs to be started, the treatment control circuit first controls the adhesive spraying control switch to be turned on, so that the adhesive spraying device M230 sprays conductive silicone onto the surface of the conductive electrodes. Then, the treatment control circuit controls the charging control switch to be turned on, charging the energy storage capacitor through the battery M280. After charging is completed, the treatment control circuit controls both the first and second control switches to be closed, and controls the discharging control switch to be turned on, discharging treatment to the patient through the first and second sets of conductive electrodes.

[0069] The storage device M240 is used to store the cardiac monitoring data acquired by the data acquisition unit M211. The alarm device M250 is used to trigger an alarm when the data processing unit M212 determines that it is necessary to enter the cardiac treatment mode. The alarm device M250 may include, for example, one or more of the following: an alarm indicator light, a buzzer, a speaker, and a vibrator, all mounted on the housing. When the data processing unit M212 determines that treatment needs to be delivered, an alarm sequence is activated, triggering one or more of the following: a light, a vibration, and a voice alarm, to alert the patient or surrounding personnel that the device is about to initiate defibrillation. Then, the dispensing, charging, and discharging processes can continue.

[0070] The response button M260 is located on the outer surface of the housing and is used to confirm the patient's consciousness. Preferably, response buttons M260 are provided on both the front and back surfaces of the housing to prevent accidental activation of a single response button M260. When the data processing unit M211 determines that cardiac treatment mode needs to be entered, if the patient and / or another person simultaneously press the response buttons M260 on both the front and back surfaces, it is confirmed that the patient is conscious, and treatment is not initiated, or the treatment procedure is terminated / delayed. The data communication device M270 can be a wireless communication device or a wired communication device. It can transmit the cardiac monitoring data collected in real time by the data acquisition unit M211 to an external device, and can also transmit the historical cardiac monitoring data stored in the storage device M250 to an external device. It can also transmit the working status, working mode, and working status of the conductive electrode M110 of the device host M200 to an external device. For example, real-time ECG monitoring data can be sent to an external device, such as a remote server, via a wireless communication device, and data in the storage device M240 can be exported to an external device via a wired or wireless communication device. The wireless communication device includes, but is not limited to, methods such as 3G, 4G, 5G, and Bluetooth. The wired communication device includes, but is not limited to, communication with external devices via a USB interface. The external devices include, but are not limited to, user-used mobile terminals such as mobile phones, laptops, desktop computers, and tablets, or remote servers.

[0071] like Figure 4 As shown in the figure, this embodiment of the invention also provides a control method for a wearable cardiac medical device. Using the aforementioned wearable cardiac medical device, the method includes the following steps:

[0072] S100: The controller collects the patient's cardiac monitoring data through the conductive electrode, at which time the medical device is in cardiac monitoring mode;

[0073] S200: The controller determines whether treatment is needed based on the cardiac monitoring data;

[0074] S300: If treatment is required, the controller delivers treatment to the patient via the conductive electrodes, at which point the medical device is in cardiac treatment mode.

[0075] Therefore, in the control method of the present invention, cardiac monitoring data is collected through conductive electrodes in step S100, and treatment is delivered through conductive electrodes in step S300. That is, ECG acquisition and defibrillation share a set of conductive electrodes, which simplifies the structure of wearable cardiac medical devices, reduces the failure rate of medical devices, and reduces the overall number of electrodes. Wearing and use are more convenient, and patient comfort and compliance are improved.

[0076] In this embodiment, step S100, in which the controller acquires the patient's cardiac monitoring data through the conductive electrode, includes the following steps:

[0077] The controller obtains the potential value from the conductive electrode;

[0078] The controller obtains the patient's electrocardiogram (ECG) signal based on the potential difference between any two non-conductive conductive electrodes, and generates the cardiac monitoring data based on the ECG signal. The cardiac monitoring data may include, for example, the ECG signal itself, an electrocardiogram (ECG) obtained from the ECG signal, and data such as heart rate and ECG signal waveform calculated from the ECG signal.

[0079] With N conductive electrodes, the number of signal channels that can be acquired is: The controller is based on the collected data Real-time analysis of ECG signals from each channel was performed, starting with... The signal quality of each channel is evaluated. Based on the results of the signal quality evaluation, the signal of the channel with better quality is selected, the patient's heart rate value is calculated, and arrhythmia analysis is performed.

[0080] In this embodiment, the plurality of conductive electrodes includes N1 first group of conductive electrodes and N2 second group of conductive electrodes, where N1 + N2 = N, and N1 and N2 are preferably greater than or equal to 2, but the present invention is not limited thereto. The medical device also includes a spraying device and an energy storage capacitor, and may further include corresponding spraying control switches, charging control switches, and discharging control switches.

[0081] like Figure 5 As shown, step S300: the controller delivers treatment to the patient through the conductive electrode, including the following steps:

[0082] S310: The controller starts the glue spraying device to spray glue onto the conductive electrode, for example by turning on the glue spraying control switch, so that the glue spraying device sprays conductive silicone onto the surface of the conductive electrode;

[0083] S320: The controller charges the energy storage capacitor, for example by turning on the charging control switch to control the battery to charge the energy storage capacitor;

[0084] S330: The controller controls the first group of conductive electrodes to conduct to each other as positive electrodes, and the second group of conductive electrodes to conduct to each other as negative electrodes. For example, the first group of conductive electrodes is made to conduct to each other by controlling the first control switch to conduct, and the second group of conductive electrodes is made to conduct to each other by controlling the second control switch to conduct.

[0085] S340: The controller controls the energy storage capacitor to discharge to the conductive electrode, and delivers treatment to the patient through the conductive electrode, for example by turning on the discharge control switch, and discharging defibrillation to the patient through the first group of conductive electrodes and the second group of conductive electrodes.

[0086] In this embodiment, after the controller delivers treatment to the patient through the conductive electrode in step S300, the method further includes the following steps:

[0087] The controller controls the disconnection between the first group of conductive electrodes and the disconnection between the second group of conductive electrodes, for example, by controlling both the first control switch and the second control switch to be disconnected.

[0088] The controller continues to collect the patient's cardiac monitoring data through the conductive electrodes. When the cardiac monitoring data is detected to return to normal, for example, when the heart rhythm automatically returns to a non-shockable rhythm, the controller automatically terminates the treatment program.

[0089] Therefore, in this embodiment, only in cardiac treatment mode are the first and second sets of conductive electrodes connected, allowing for cardiac treatment such as defibrillation, and preventing the acquisition of ECG monitoring data. Before and after the cardiac treatment mode is activated, the system reverts to cardiac monitoring mode, where all conductive electrodes are no longer connected.

[0090] In this embodiment, the medical device further includes a motion sensor. Step S200: The controller determines whether treatment is needed based on the cardiac monitoring data, including the following steps:

[0091] The controller acquires motion data from the motion sensor, and the motion data can be collected synchronously with the electrocardiogram monitoring data. The controller can determine the patient's current motion status based on the motion data.

[0092] The controller comprehensively determines whether treatment is needed based on the cardiac monitoring data and the motion data, thereby reducing the incidence of false alarms and false defibrillation of shockable heart rate (VF / VT) during patient movement.

[0093] In traditional wearable external automated defibrillators (AEDs), after the patient wears the device and ECG data is collected, real-time arrhythmia analysis is performed. When a shockable heart rate is detected, defibrillation is initiated. However, the collected cardiac monitoring data is not saved on the device's main unit, nor is it transmitted wirelessly to an external storage facility. After the device is discontinued, the collected dynamic ECG data cannot be re-analyzed, and the patient's arrhythmia status is not analyzed or statistically analyzed. Therefore, a significant amount of information related to sudden cardiac death, such as heart rate, arrhythmias, and heart rate variability, is lost, especially for patients at high risk of sudden cardiac death who require continuous device use for 3-6 months. Therefore, this invention further allows for the analysis and statistical analysis of cardiac monitoring data via an external device, providing patients with analysis reports informing them of their cardiac status and assessing the risk of sudden cardiac death. This external device includes, but is not limited to, user-used mobile terminals such as mobile phones, laptops, desktop computers, and tablets, or remote servers. The following will combine... Figure 6 This section provides a detailed description of how the external device works.

[0094] like Figure 6 As shown, this embodiment of the invention also provides a medical system, including the wearable cardiac medical device M10 and an external device M40. The medical device M10 includes at least a data communication device M270. The external device M40 is used to acquire and store cardiac monitoring data from the data communication device M270 of the wearable cardiac medical device M10. The data communication device M270 can be a wireless communication device, communicating with the external device M40 using 3G, 4G, 5G, Bluetooth, etc., or it can be a wired communication device, communicating with the external device M40 using USB, etc. The invention is not limited to these methods.

[0095] In this embodiment, the external device M40 includes a data storage module M410 for storing cardiac monitoring data acquired from the medical device M10, as well as data, reports, models, etc., generated by its own calculations. The external device M40 also includes a dynamic analysis module M420 for analyzing the cardiac monitoring data using a preset dynamic analysis algorithm, such as Holter monitoring, to obtain dynamic analysis indicators and generate a dynamic analysis report within a first time frame. Holter monitoring involves recording a patient's cardiac electrical activity continuously for 24 hours or longer under normal living conditions, and then analyzing the data using a computer to detect arrhythmias and myocardial ischemia that are difficult to detect during routine electrocardiogram examinations, providing important objective evidence for clinical diagnosis, treatment, and efficacy assessment. The dynamic analysis indicators may include, for example, heart rate, arrhythmia status, and heart rate variability. The first time frame may be, for example, 1 day, 3 days, or 5 days.

[0096] In this embodiment, the external device M40 further includes a trend analysis module M430, used to analyze the dynamic analysis indicators using a preset trend analysis algorithm, obtain trend analysis indicators, and generate a trend analysis report within a second time range, which is longer than the first time range. This second time range can be, for example, one week, one month, or three months. The trend analysis report can be provided to doctors for guidance and adjustment of clinical medication for arrhythmias. The trend analysis indicators can be, for example, heart rate variability rate or frequency of arrhythmia occurrence. The trend analysis report can use graphs, line graphs, or other formats to represent the changing trend.

[0097] In this embodiment, the external device M40 further includes a risk assessment module M440. This module M440 contains a pre-trained sudden cardiac death risk assessment model and is used to extract risk assessment features based on one or more of the following: patient information, cardiac monitoring data, dynamic analysis indicators, and trend analysis indicators. These risk assessment features are then input into the trained sudden cardiac death risk assessment model to obtain a sudden cardiac death risk assessment value. The risk assessment features include attribute values ​​corresponding to multiple attributes, such as the average heart rate over a certain time period, the frequency of arrhythmias, and the trend of arrhythmias. They may also include basic patient information, such as the patient's age and gender. The sudden cardiac death risk assessment model can employ a machine learning model, such as a deep learning model, support vector machine, or decision tree. The input to the sudden cardiac death risk assessment model is the risk assessment features, and the output is the sudden cardiac death risk assessment value, i.e., the risk of sudden cardiac death. This risk assessment value for sudden cardiac death can help doctors, patients, or their families decide whether to continue wearing the wearable cardiac medical device or whether to upgrade to an implantable cardiac medical device, such as an ICD (Implantable Cardioverter Defibrillator). For example, a first risk threshold and a second risk threshold can be set. If the first risk threshold is greater than the second risk threshold, and the risk assessment value for sudden cardiac death is greater than the first risk threshold, then an upgrade to an implantable cardiac medical device is necessary. If the risk assessment value for sudden cardiac death is between the first and second risk thresholds, then wearing the wearable cardiac medical device should continue. If the risk assessment value for sudden cardiac death is less than the first risk threshold, then wearing the wearable cardiac medical device is not necessary.

[0098] In this embodiment, the external device is also used to collect multiple training samples, construct a training sample set, add risk assessment value labels to the training samples, and train the sudden cardiac death risk assessment model based on the training sample set and the corresponding risk assessment value labels. The training samples can be obtained from one or more of the following: outpatient data, hospital databases, exported data from wearable cardiac medical devices, and exported data from implantable medical devices. The data in the training samples is organized to obtain risk assessment features corresponding to each patient, and labels are added based on whether the patient has experienced sudden cardiac death; if it has, it is marked as 1, and if not, it is marked as 0, forming positive and negative samples. Then, the sudden cardiac death risk assessment model is iteratively trained using positive and negative samples. A loss function value is calculated based on the output of the sudden cardiac death risk assessment model and the corresponding risk assessment value labels. Training is stopped when the loss function value is less than a preset loss threshold, resulting in a trained sudden cardiac death risk assessment model.

[0099] The above description, in conjunction with specific preferred embodiments, provides a further detailed explanation of the present invention. It should not be construed that the specific implementation of the present invention is limited to these descriptions. For those skilled in the art, various simple deductions or substitutions can be made without departing from the concept of the present invention, and all such modifications and substitutions should be considered within the scope of protection of the present invention.

Claims

1. A wearable cardiac medical device, characterized in that, include: Multiple conductive electrodes, all of which are electrodes that simultaneously have electrocardiogram monitoring and electrocardiogram therapy functions; the multiple conductive electrodes include a first group of conductive electrodes and a second group of conductive electrodes, the first group of conductive electrodes includes multiple conductive electrodes, the second group of conductive electrodes includes multiple conductive electrodes, the first group of conductive electrodes is provided with at least one first control switch, and the second group of conductive electrodes is provided with at least one second control switch. A controller is connected to the plurality of conductive electrodes. The controller is used to collect the patient's cardiac monitoring data through the conductive electrodes in cardiac monitoring mode, determine whether to enter cardiac treatment mode based on the cardiac monitoring data, and deliver treatment to the patient through the conductive electrodes in cardiac treatment mode. In cardiac monitoring mode, the controller controls the first control switch and the second control switch to be disconnected, so that all conductive electrodes are not connected to each other. Potential values ​​are obtained from the conductive electrodes, and the patient's electrocardiogram (ECG) signal is obtained based on the potential difference between any two non-conductive conductive electrodes. The signal quality of multiple ECG signals is evaluated, and the ECG signal that meets the preset quality requirements is selected for cardiac index analysis to generate the cardiac monitoring data. In cardiac treatment mode, the controller controls the first control switch and the second control switch to close, so that all conductive electrodes in the first group of conductive electrodes are connected to each other as positive electrodes, and all conductive electrodes in the second group of conductive electrodes are connected to each other as negative electrodes, and discharge treatment is applied to the patient through the first group of conductive electrodes and the second group of conductive electrodes. The medical device also includes a data communication device configured to send cardiac monitoring data to an external device. The external device is configured to analyze the cardiac monitoring data using a preset dynamic analysis algorithm to obtain dynamic analysis indicators, generate a dynamic analysis report within a first time range, and obtain trend analysis indicators based on the dynamic analysis indicators to generate a trend analysis report within a second time range, wherein the second time range is greater than the first time range.

2. The wearable cardiac medical device according to claim 1, characterized in that, The controller includes N conductive electrodes and performs signal quality assessment on multiple electrocardiogram (ECG) signals, including assessing the signal quality of ECG signals from each signal channel.

3. The wearable cardiac medical device according to claim 2, characterized in that, A first control switch is provided between any two conductive electrodes in the first group of conductive electrodes, and a second control switch is provided between any two conductive electrodes in the second group of conductive electrodes.

4. The wearable cardiac medical device according to claim 1, characterized in that, It also includes a glue spraying device, and in cardiac treatment mode, the controller is also used to activate the glue spraying device to spray glue onto the conductive electrodes.

5. The wearable cardiac medical device according to claim 1, characterized in that, It also includes an energy storage capacitor, which the controller also charges during cardiac treatment mode.

6. The wearable cardiac medical device according to claim 1, characterized in that, One set of the first group of conductive electrodes and the second group of conductive electrodes are placed on the patient's chest, and the other set is placed on the patient's back.

7. The wearable cardiac medical device according to claim 1, characterized in that, Both the first group of conductive electrodes and the second group of conductive electrodes are placed on the patient's chest, and the first group of conductive electrodes and the second group of conductive electrodes are arranged diagonally.

8. The wearable cardiac medical device according to claim 1, characterized in that, It also includes a motion sensor, and the controller is further configured to acquire the patient's motion data from the motion sensor and determine whether to enter cardiac treatment mode based on the cardiac monitoring data and the motion data.

9. The wearable cardiac medical device according to claim 1, characterized in that, It also includes a data communication device for transmitting the cardiac monitoring data to an external device, the data communication device including a wired communication device and / or a wireless communication device.

10. The wearable cardiac medical device according to claim 1, characterized in that, It also includes a display device connected to the controller for displaying at least one of patient information, cardiac monitoring data, device status data, and electrode status data, and / or receiving at least one of user-set treatment control parameters, device operating status control commands, and electrode operating status control commands.

11. A medical system, characterized in that, include: The wearable cardiac medical device according to any one of claims 1 to 10; An external device is used to acquire and store cardiac monitoring data from the data communication device of the wearable cardiac medical device. The external device is also used to analyze the cardiac monitoring data using a preset dynamic analysis algorithm to obtain dynamic analysis indicators and generate a dynamic analysis report within a first time range. The external device is also used to analyze the dynamic analysis indicators using a preset trend analysis algorithm to obtain trend analysis indicators and generate a trend analysis report within a second time range, wherein the second time range is greater than the first time range.

12. The medical system according to claim 11, characterized in that, The external device is also used to extract risk assessment features based on one or more of the patient information, the cardiac monitoring data, the dynamic analysis indicators, and the trend analysis indicators, and input the risk assessment features into the trained sudden cardiac death risk assessment model to obtain a sudden cardiac death risk assessment value.

13. The medical system according to claim 12, characterized in that, The external device is also used to collect multiple training samples, construct a training sample set, add risk assessment value labels to the training samples, and train the sudden cardiac death risk assessment model based on the training sample set and the corresponding risk assessment value labels.

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