Electrocardiogram monitoring system

Abstract

The present application discloses an electrocardiogram monitoring system and relates to the technical field of electrocardiogram signal acquisition. The system comprises: a positive electrode, arranged in an electrocardiogram signal acquisition pad, close to a first position in the electrocardiogram signal acquisition pad; a first negative electrode, arranged a preset distance apart from the positive electrode; and other negative electrodes, sequentially arranged such that after a user lies on the electrocardiogram signal acquisition pad, the positive electrode is close to the scapula of the user, and at least one negative electrode is close to the lower edge of the rib of the user. In the acquisition system, a driving circuit is connected to each signal processing circuit and a driving electrode layer; a positive electrode and a negative electrode in each column of electrocardiogram signal acquisition electrodes are both connected to a corresponding signal processing circuit; the signal processing circuits are further connected to a storage module. The signal processing circuits are configured for preprocessing electrocardiogram signals acquired by each electrocardiogram signal acquisition channel, and sending the preprocessed electrocardiogram signals to the storage module for storage.

Description

Electrocardiogram monitoring system

[0001] Priority application

[0002] This application claims priority to Chinese Patent Application No. 202411028725.1, entitled "Electrocardiogram Monitoring System", filed on July 30, 2024. Technical Field

[0003] This application relates to the field of electrocardiogram (ECG) signal acquisition technology, and in particular to an ECG monitoring system. Background Technology

[0004] An electrocardiogram (ECG) plays a vital role in modern medical diagnosis and treatment by recording heart activity to help assess sleep quality, diagnose heart health, and treat sleep disorders.

[0005] Currently, the most common method for acquiring an electrocardiogram (ECG) is contact-based. During ECG acquisition, two or more metal or silver chloride gel electrodes are fixed to specific locations on the user's body, and the ECG signal is obtained by measuring the change in potential difference between these locations.

[0006] However, during long-term monitoring (such as Holter monitoring), the electrodes are prone to loosening and disconnection, especially when turning over in sleep at night, which makes the measured ECG signal inaccurate. Summary of the Invention

[0007] The purpose of this application is to provide an electrocardiogram (ECG) monitoring system that can monitor a user's ECG signals over long periods without the need for contactless or adhesive electrode pads.

[0008] To achieve the above objectives, this application provides the following solution:

[0009] This application provides an electrocardiogram (ECG) monitoring system, comprising:

[0010] ECG signal acquisition pad and acquisition circuit system;

[0011] The electrocardiogram (ECG) signal acquisition pad includes: a first outer insulating layer, an ECG signal acquisition layer, an inner insulating layer, a driving electrode layer, and a second outer insulating layer, which are stacked from top to bottom;

[0012] The electrocardiogram (ECG) signal acquisition layer includes: multiple rows of ECG signal acquisition electrodes;

[0013] Each column of ECG signal acquisition electrodes includes: one positive electrode and multiple negative electrodes;

[0014] The positive electrode is positioned near a first location in the ECG signal acquisition pad, which corresponds to the position of the user's shoulder blade while lying on the ECG signal acquisition pad. The first negative electrode is positioned at a preset distance from the positive electrode. Other negative electrodes are arranged sequentially after the first negative electrode, so that when the user lies on the ECG signal acquisition pad, the positive electrode is close to the user's shoulder blade, and at least one negative electrode is close to the lower edge of the user's ribs.

[0015] The acquisition circuit system includes: an analog front-end and a digital processing and storage circuit;

[0016] The analog front end includes a driving circuit and a signal processing circuit corresponding to each column of ECG signal acquisition electrodes; the digital processing and storage circuit includes a storage module; the input terminal of the driving circuit is connected to the first output terminal of each signal processing circuit, and the output terminal of the driving circuit is connected to the driving electrode layer; the positive electrode and the negative electrode in each column of ECG signal acquisition electrodes are connected to the input terminal of the corresponding signal processing circuit, and in each column of ECG acquisition electrodes, the positive electrode and each negative electrode form an ECG signal acquisition channel; the second output terminal of the signal processing circuit is connected to the storage module, and the signal processing circuit is used to preprocess the ECG signals acquired by each ECG signal acquisition channel and send the preprocessed ECG signals to the storage module for storage. Attached Figure Description

[0017] To more clearly illustrate the technical solutions in the embodiments of this application or the prior art, the drawings used in the embodiments will be briefly introduced below. Obviously, the drawings described below are only some embodiments of this application. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0018] Figure 1 is a schematic diagram of an electrocardiogram monitoring system according to an exemplary embodiment;

[0019] Figure 2 is an exploded view of an electrocardiogram signal acquisition pad according to an exemplary embodiment;

[0020] Figure 3 is a schematic diagram of the structure of a row of signal acquisition electrodes in Figure 1;

[0021] Figure 4 is a schematic diagram of an electrocardiogram signal acquisition pad with four rows of signal acquisition electrodes according to an exemplary embodiment;

[0022] Figure 5 is a schematic diagram of the circuit structure of an electrocardiogram monitoring system according to an exemplary embodiment;

[0023] Figure 6 is a schematic diagram of the structure of an electrocardiogram monitoring system according to an exemplary embodiment;

[0024] Figure 7 is a cross-sectional view of an electrocardiogram (ECG) signal acquisition pad according to an exemplary embodiment;

[0025] Figure 8 is a cross-sectional view of an electrocardiogram signal acquisition pad according to an exemplary embodiment;

[0026] Figure 9 is an exploded view of an electrocardiogram (ECG) signal acquisition pad with the ECG signal acquisition layer, inner insulating layer, driving electrode layer and second outer insulating layer stacked according to an exemplary embodiment.

[0027] Figure 10 is a schematic diagram illustrating a supine sleeping position according to an exemplary embodiment;

[0028] Figure 11 is a schematic diagram illustrating a right-lying sleeping position according to an exemplary embodiment;

[0029] Figure 12 is a schematic diagram illustrating a left-lying sleeping position according to an exemplary embodiment;

[0030] Figure 13 is a schematic diagram illustrating the positional relationship between the driving electrode layer, the signal acquisition electrode, the clothing and air layer, and the human skin according to an exemplary embodiment.

[0031] Figure 14 is a schematic diagram illustrating a human standing posture according to an exemplary embodiment;

[0032] Figure 15 is a schematic diagram illustrating the height of the driving electrode layer according to an exemplary embodiment;

[0033] Figure 16 is a schematic diagram of a human body according to an exemplary embodiment;

[0034] Figure 17 is a schematic diagram illustrating the range of motion of a human body while lying down, according to an exemplary embodiment;

[0035] Figure 18 is a schematic diagram illustrating the width of the driving electrode layer according to an exemplary embodiment;

[0036] Figure 19 is a schematic diagram illustrating a human sitting posture according to an exemplary embodiment;

[0037] Figure 20 is a schematic diagram illustrating the height between the positive electrode and the first negative electrode according to an exemplary embodiment;

[0038] Figure 21 is a schematic diagram showing the width of a signal acquisition electrode according to an exemplary embodiment;

[0039] Figure 22 is a circuit diagram of a data acquisition circuit system according to an exemplary embodiment;

[0040] Figure 23 is a circuit diagram of a data acquisition circuit system according to an exemplary embodiment.

[0041] Explanation of reference numerals in the attached figures: 1-ECG signal acquisition pad; 2-Acquisition circuit system; 11-First outer insulating layer; 111-Hollowed-out structure; 12-ECG signal acquisition layer; 121-Each row of ECG signal acquisition electrodes; 1211-Positive electrode; 12111-Silver fiber fabric conductive layer of the positive electrode; 12112-Protective layer of the positive electrode; 1212-Negative electrode; 12121-Silver fiber fabric conductive layer of the negative electrode; 12122-Protective layer of the negative electrode; 212a-Positive signal processing circuit; 212b-Negative signal processing circuit; 212c-Channel signal processing circuit; 13-Internal insulating layer; 14-Drive electrode layer; 141-Silver fiber fabric conductive layer of driving electrode layer; 142-Protective layer of driving electrode layer; 15-Second external insulating layer; 16-Conductive wire; 161-Silver fiber conductive braided wire; 162-Insulating braided wire sleeve; 17-Edging strip; 21-Analog front end; 211-Drive circuit; 212-Signal processing circuit; 22-Digital processing and storage circuit; 221-Storage module; 222-Linear regulator; 223-Microcontroller (MCU); 224-WiFi network card; 31-Power module; 311-Battery; 312-Charging circuit; 41-Isolator; 411-Isolated power supply; 412-Digital isolator. Detailed Implementation

[0042] The technical solutions of the embodiments of this application will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of this application, and not all embodiments. Based on the embodiments of this application, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of this application.

[0043] To make the above-mentioned objectives, features and advantages of this application more apparent and understandable, the application will be further described in detail below with reference to the accompanying drawings and specific embodiments.

[0044] Currently, cardiovascular disease causes more than 17 million deaths globally each year, accounting for 31% of all deaths worldwide, and this number is projected to increase to 23.6 million by 2030. In my country, there are 330 million cardiovascular disease patients, and 77% of deaths occur at home. However, 90% of cardiovascular diseases can be detected and prevented early; therefore, continuous and real-time cardiovascular monitoring can effectively reduce the incidence and mortality of cardiovascular diseases.

[0045] However, current technical methods have the following drawbacks:

[0046] (1) Late screening: Early cardiovascular diseases are asymptomatic or have mild symptoms (such as atrial fibrillation). Once the treatment window is missed, they may develop into malignant diseases (malignant arrhythmia, myocardial infarction, etc.), which directly endanger life. People with chronic diseases such as diabetes are prone to complications and need to pay close attention to their heart health. However, there is currently no reliable long-term continuous and comfortable monitoring method. Users can only rely on regular physical examinations, which cannot detect changes in the condition in time and control the development of the condition in time, thus missing the opportunity for treatment.

[0047] (2) Slow diagnosis: Hospitals commonly use electrocardiograms (ECGs) as the gold standard for diagnosing cardiovascular diseases. Currently, hospital ECGs are divided into short-time ECGs (also known as static ECGs) (30s) and Holter monitoring (24h). However, this method requires professional medical staff to make precise connections and attach multiple disposable wet electrodes to the user's body. The process is cumbersome, and the wet electrodes are in contact with the skin for a long time, which may cause adverse reactions such as skin allergies in some people. In addition, during long-term monitoring (such as Holter monitoring), the electrodes are prone to loosening or disconnection, especially during strenuous exercise during the day or when turning over in sleep at night, which will introduce noise interference and signal distortion, making the test results inaccurate. Furthermore, due to the short monitoring time, both short-time ECGs and Holter monitoring cannot fully capture short-term abnormalities such as paroxysmal arrhythmias. Patients often feel uncomfortable and seek medical attention, but after several examinations, they still cannot get a diagnosis.

[0048] (3) Treatment and prognosis: Patients diagnosed with the disease need to be checked regularly after surgery or drug treatment to prevent recurrence. Each check requires the above-mentioned electrocardiogram examination procedure. The long-term and cumbersome check-up results in low patient compliance and difficulty in long-term monitoring, leading to a high recurrence rate and poor overall prognosis.

[0049] In summary, electrocardiography (ECG) plays a crucial role in modern medical diagnosis and treatment by recording cardiac activity to help assess sleep quality, diagnose heart health, and treat sleep disorders. However, from a technical perspective, traditional contact ECG involves fixing two or more metal or silver chloride gel electrodes (the aforementioned wet electrodes) to specific locations on the body and measuring the potential difference changes between these locations to obtain ECG signals. This method of directly contacting the wet electrodes with the skin surface for ECG measurement has the following main drawbacks:

[0050] (1) The collection process is complicated and requires professional medical personnel to accurately place multiple electrodes, which may complicate the implementation in a home environment;

[0051] (2) Prolonged contact of disposable wet electrodes with the skin may cause adverse reactions such as skin allergies;

[0052] (3) During long-term monitoring (e.g., Holter monitoring), the electrodes are prone to loosening or disconnection, especially during strenuous exercise during the day or when turning over in sleep at night, which can introduce noise interference and signal distortion.

[0053] (4) Because electrodes must be worn at all times during measurement, it is not possible to continuously monitor and assess cardiac status on a longer timescale (e.g., for several months or years).

[0054] In the typical scenario of cardiovascular disease, daily screening, early diagnosis, confirmation, and long-term prognostic assessment of high-risk individuals all require continuous electrocardiogram monitoring. Currently, these assessments rely on static electrocardiograms and Holter monitoring performed in or around hospitals, which cannot cover a wider range of monitoring time and space. This makes it difficult to capture paroxysmal arrhythmias such as short runs of ventricular tachycardia, affecting diagnostic and prognostic outcomes.

[0055] Therefore, capacitive coupling ECG monitoring technology has been studied as an alternative method for capturing ECG signals. Ideally, this method can continuously monitor ECG waveforms imperceptibly without direct contact with human skin, while ensuring data accuracy and reliability. This eliminates the physical discomfort and inconvenience caused by traditional contact ECG measurements, providing a more comfortable user experience.

[0056] The core of capacitive coupling electrocardiogram (ECG) monitoring technology is to use a capacitive coupling model of skin-dielectric-electrode, rather than the conventional skin-electrode model, to acquire ECG signals, and to design appropriate supporting hardware, software, and algorithms accordingly. In other words, the ECG signal is coupled to the electrode through an equivalent capacitance to be input to the back-end measurement circuit. The dielectric in this equivalent capacitance is composed of an air layer, clothing, or other textiles.

[0057] Capacitive coupling ECG monitoring technology has significant advantages over other existing smart healthcare non-contact cardiac monitoring technologies (such as those based on photoplethysmography, fiber optic vibration sensing, and radio frequency radar):

[0058] (1) Existing technologies can only collect heart rate and do not contain richer information about cardiac activity, such as PR interval and ST segment elevation.

[0059] (2) Unlike photoplethysmography, it does not need to be worn on the body and come into contact with the skin, nor does it actively send electromagnetic waves and generate radiation like radio frequency radar.

[0060] (3) The cost is lower than that of fiber optic vibration sensing and radio frequency radar.

[0061] Based on capacitive coupling electrocardiogram monitoring technology, this disclosure proposes an electrocardiogram monitoring system.

[0062] Figure 1 is a schematic diagram of an electrocardiogram (ECG) monitoring system according to an exemplary embodiment. As shown in Figure 1, the ECG monitoring system includes:

[0063] ECG signal acquisition pad 1 and acquisition circuit system 2;

[0064] As shown in Figure 2, the ECG signal acquisition pad 1 includes: a first outer insulating layer 11, an ECG signal acquisition layer 12, an inner insulating layer 13, a driving electrode layer 14, and a second outer insulating layer 15, which are stacked from top to bottom.

[0065] As shown in Figures 1 and 3, the electrocardiogram (ECG) signal acquisition layer 12 includes multiple rows of ECG signal acquisition electrodes 121; each row of ECG signal acquisition electrodes 121 includes a positive electrode 1211 and multiple negative electrodes 1212.

[0066] A positive electrode 1211 is positioned near a first location in the ECG signal acquisition pad 1, which corresponds to the position of the user's shoulder blade while lying on the ECG signal acquisition pad 1. A first negative electrode 1212 is positioned at a preset distance from the positive electrode 1211. Other negative electrodes 1212 are arranged sequentially after the first negative electrode 1212, so that when the user lies on the ECG signal acquisition pad 1, the positive electrode 1211 is close to the user's shoulder blade, and at least one negative electrode 1212 is close to the lower edge of the user's ribs.

[0067] For example, as shown in Figure 4, four columns of ECG signal acquisition electrodes are illustrated. Each column of ECG signal acquisition electrodes 121 includes one positive electrode 1211 and two negative electrodes 1212. From left to right, the first column of ECG signal acquisition electrodes includes: positive electrode CH1-P, negative electrode CH1-N1, and negative electrode CH1-N2; the second column of ECG signal acquisition electrodes includes: positive electrode CH2-P, negative electrode CH2-N1, and negative electrode CH2-N2; the third column of ECG signal acquisition electrodes includes: positive electrode CH3-P, negative electrode CH3-N1, and negative electrode CH3-N2; and the fourth column of ECG signal acquisition electrodes includes: positive electrode CH4-P, negative electrode CH4-N1, and negative electrode CH4-N2.

[0068] In this disclosure, since multiple negative electrodes 1212 are provided in each column of ECG signal acquisition electrodes 121, the measurement of ECG signals is not limited by the user's height. There will always be a negative electrode 1212 at the lower edge of the user's ribs. In this way, the potential difference change between the two positions from the scapula to the lower edge of the ribs can be measured by the positive electrode 1211 at the user's scapula position and the negative electrode 1212 at the lower edge of the user's ribs, so as to obtain an ECG signal similar to that of a traditional two-lead ECG (right hand to left leg).

[0069] Furthermore, to improve the user's comfort while lying on the ECG signal acquisition pad 1, the drive electrode layer 14, the positive electrode 1211, and the negative electrode 1212 can all be made of silver fiber fabric conductive material.

[0070] To ensure the quality of electrode coupling, the driving electrode layer 14, positive electrode 1211, and negative electrode 1212, made of silver fiber conductive material, can better conform to the curve of the human body contact surface when the user lies on the ECG signal acquisition pad 1. In one possible implementation, as shown in Figure 2, the driving electrode layer 14 includes a protective layer 142 of the driving electrode layer stacked from bottom to top and a silver fiber conductive layer 141 of the driving electrode layer made of silver fiber conductive material. The positive electrode 1211 also includes a protective layer 12112 of the positive electrode stacked from bottom to top and a silver fiber conductive layer 12111 of the positive electrode made of silver fiber conductive material. The negative electrode 1212 also includes a protective layer 12122 of the negative electrode stacked from bottom to top and a silver fiber conductive layer 12121 of the negative electrode made of silver fiber conductive material. For example, the material of the above-mentioned protective layer can be memory foam.

[0071] To further enhance the user's comfort while lying on the ECG signal acquisition pad 1 and to ensure the insulation between the electrodes, the first outer insulation layer 11, the inner insulation layer 13, and the second outer insulation layer 15 are all made of insulating fabric.

[0072] Referring to Figure 5, the acquisition circuit system 2 includes: an analog front-end 21 and a digital processing and storage circuit 22.

[0073] The analog front-end 21 includes a driving circuit 211 and a signal processing circuit 212 corresponding to each column of ECG signal acquisition electrodes 121; the digital processing and storage circuit 22 includes a storage module 221.

[0074] The input terminal of the driving circuit 211 is connected to the first output terminal of each signal processing circuit 212, and the output terminal of the driving circuit 211 is connected to the driving electrode layer 14. The positive electrode 1211 and the negative electrode 1212 in each column of ECG signal acquisition electrodes 121 are connected to the input terminal of the corresponding signal processing circuit 212. In each column of ECG acquisition electrodes, the positive electrode 1211 and each negative electrode 1212 form a differential ECG signal acquisition channel. The second output terminal of the signal processing circuit 212 is connected to the storage module 221. The signal processing circuit 212 is used to preprocess the ECG signals acquired by each ECG signal acquisition channel and send the preprocessed ECG signals to the storage module 221 for storage.

[0075] Taking Figure 4 as an example, Figure 4 shows 8 ECG signal acquisition channels. Each column of ECG signal acquisition electrodes 121 includes 2 ECG signal acquisition channels. From left to right, CH1-P and CH1-N1 in the first column of ECG signal acquisition electrodes form the first ECG signal acquisition channel in the first column, and CH1-P and CH1-N2 in the first column of ECG signal acquisition electrodes form the second ECG signal acquisition channel in the first column; CH2-P and CH2-N1 in the second column of ECG signal acquisition electrodes form the first ECG signal acquisition channel in the second column, and CH1-P and CH1-N2 in the second column of ECG signal acquisition electrodes form the third ECG signal acquisition channel in the second column of ECG signal acquisition electrodes. H2-P and CH2-N2 form the second ECG signal acquisition channel in the second column; CH3-P and CH3-N1 in the third column form the first ECG signal acquisition channel in the third column, and CH3-P and CH3-N2 in the third column form the second ECG signal acquisition channel in the third column; CH4-P and CH4-N1 in the fourth column form the first ECG signal acquisition channel in the fourth column, and CH4-P and CH4-N2 in the fourth column form the second ECG signal acquisition channel in the fourth column.

[0076] The ECG signal acquisition pad 1 in this disclosure can also be called a multi-channel stacked flexible electrode pad.

[0077] In one possible implementation, the positive electrode 1211 and the negative electrode 1212 are connected to the corresponding signal processing circuit 212 via conductive lines 16; the output terminal of the driving circuit 211 is connected to the driving electrode layer 14 via conductive lines 16.

[0078] For example, the conductive wire 16 includes a flexible conductive fabric blend that is soft and elastic, and can stretch within a certain range with the deformation of the pad when the user lies on the ECG signal acquisition pad 1 without affecting its electrical properties.

[0079] In this disclosure, both the analog front-end 21 and the digital processing and storage circuit 22 are on a printed circuit board. Therefore, the input terminal of the drive circuit 211 is connected to the first output terminal of each signal processing circuit 212 via ordinary wires on the circuit board.

[0080] As shown in Figure 2, the flexible conductive fabric blended yarn consists of silver fiber conductive braided yarn 161 and an insulating braided sheath 162 wrapped around the silver fiber conductive braided yarn 161.

[0081] The signal processing circuit 212 in this disclosure can receive ECG signals acquired by each ECG signal acquisition channel, preprocess the ECG signals, and save them to the storage module 221. In this way, the user's ECG signals acquired by each ECG signal acquisition channel can be viewed later through the data stored in the storage module 221.

[0082] In one possible implementation, since there are many ECG signal acquisition channels in the ECG signal acquisition pad 1, and not every ECG signal acquisition channel acquires ECG signals of satisfactory quality, the signal processing circuit 212 is also used to evaluate the quality score of the ECG signal acquired by each ECG signal acquisition channel after preprocessing, and send the quality score of each ECG signal to the storage module 221 for storage. In this way, when the user's ECG signal acquired by each ECG signal acquisition channel is viewed through the data stored in the storage module 221 later, the quality score corresponding to each ECG signal will be displayed at the preset position of each ECG signal.

[0083] In another possible implementation, since ECG signals with poor quality have no diagnostic value and would waste the storage space of storage module 221, after evaluating the quality score of the ECG signals acquired by each ECG signal acquisition channel after preprocessing, signal processing circuit 212 sends the first target ECG signal with a quality score greater than the first preset score and the quality score of the first target ECG signal to storage module 221 for storage. In this way, only ECG signals with better quality are stored in storage module 221, thereby saving storage space in storage module 221. When the user views the signal, only the ECG signal with better quality and its quality score will be displayed, thereby reducing the complexity of viewing ECG signals.

[0084] In another possible implementation, in order to enable users to view their own electrocardiogram (ECG) signals in real time, a communication module can be added to the acquisition system. The acquisition system can be connected to the display terminal through the communication module, so that users can view their ECG signals in real time through the display terminal. The communication module can establish wireless or wired communication with the display terminal.

[0085] For example, the display terminal can be a mobile terminal, such as a mobile phone. Users can install the corresponding APP for the ECG monitoring system on their mobile phones in advance, and then they can use the APP on their mobile phones to view their ECG signals in real time.

[0086] For example, as shown in Figure 6, the display terminal can be a host computer. In this case, the ECG monitoring system also includes: a host computer; the second output terminal of the signal processing circuit 212 is also connected to the host computer. The signal processing circuit 212 is used to send the ECG signals collected by each ECG signal acquisition channel after preprocessing to the host computer; the host computer is used to display the ECG signals through the display device in the host computer.

[0087] In another possible implementation, when a host computer is included, the evaluation of the ECG signal can be performed by the host computer. In this case, the signal processing circuit 212 is not required for evaluation, thus simplifying the signal processing circuit 212. Specifically, the host computer is used to evaluate the quality score of the ECG signal acquired by each ECG signal acquisition channel after preprocessing, obtain the target ECG signal whose quality score is greater than the preset score, calculate the cardiac activity index based on the target ECG signal, and output the ECG signals, the quality score of each ECG signal, and the cardiac activity index through the display device.

[0088] To allow users to view their ECG signals more clearly, when displaying ECG signals on a display device, only the target ECG signal, the quality score of the target ECG signal, and cardiac activity indicators can be displayed.

[0089] Specifically, the host computer includes not only the aforementioned display device but also a server. Taking the establishment of wireless communication between the communication module of the acquisition system and the host computer as an example, the server establishes a TCP service listener and can automatically connect to the acquisition circuit system 2 after power-on via WiFi. It receives ECG signals from each ECG signal acquisition channel uploaded in real time by the acquisition circuit system 2, and applies an FIR filter (0.5-45Hz bandpass filter) to each ECG signal acquired by each channel to remove coupled DC component noise and high-frequency noise, including power frequency noise. The signal quality assessment algorithm is used to evaluate the signal acquired by each ECG signal acquisition channel to obtain a real-time signal quality score. The channel corresponding to the target ECG signal with a preset score is selected as the main channel for clinical use. R-waves are extracted from the data of these channels to calculate the real-time heart rate. The display device displays the filtered ECG signals acquired by each ECG signal acquisition channel and their corresponding quality scores. During display, the background of the signal graph can be displayed in different colors according to the quality score and signal level for differentiation. The R-wave position is marked on the main clinical channel, and the real-time heart rate is displayed.

[0090] The driving circuit 211 in this disclosure functions similarly to the right leg driving circuit 211 (RLD driving circuit) in related technologies, and the driving electrode layer 14 functions similarly to the right leg driving electrode (RLD electrode) in related technologies. It is used to shield some of the interfering electromagnetic waves from space and from below the positive electrode 1211 and negative electrode 1212, such as power frequency noise and its harmonics, and high-frequency pulse noise emitted by surrounding electrical appliances. The driving circuit 211 is also used to average the potentials of all positive electrodes 1211 and negative electrodes 1212 to obtain a common-mode interference signal, invert it, and output it to the driving electrode layer 14 so that the high-frequency part of the inverted common-mode signal is sent back to the human body through capacitive coupling to cancel some of the common-mode interference. In order to improve the shielding effect and the common-mode interference cancellation effect, the size of the driving electrode layer 14 can be set to be relatively large. For example, the size of the driving electrode layer 14 is larger than the size of the ECG signal acquisition layer 12 and smaller than or equal to the size of the first external insulating layer 11.

[0091] In one embodiment, as shown in FIG2, the outer periphery of the first outer insulating layer 11 and the second outer insulating layer 15 is wrapped with an edge strip 17.

[0092] In one embodiment, as shown in FIG2, the first outer insulating layer 11 has a hollow structure 111 at the position corresponding to the positive electrode 1211, the position corresponding to the negative electrode 1212, the position between the positive electrode 1211 and the negative electrode 1212, and the position between two adjacent rows of negative electrodes 1212.

[0093] As shown in Figures 7 and 8, the first outer insulating layer 11, i.e., the uppermost insulating fabric layer, has a perforated structure 111 at the corresponding position where the electrode needs to be exposed. The size of the perforated structure 111 is slightly smaller than the corresponding electrode size, so that the electrode edge can be pressed by the fabric. This design can cover and protect the position where the conductive wire 16 is sewn to the electrode, and can effectively prevent the problem of delamination of the laminated structure under long-term use.

[0094] Specifically, the ECG signal acquisition pad 1 is the core of the acquisition coupling capacitor. It is a thin pad composed of a silver fiber conductive fabric conductive layer, a flexible conductive fabric blended yarn conductive wire 16, a memory foam protective layer, and an insulating fabric insulating layer. The silver fiber conductive fabric forms multiple measuring electrodes (positive and negative electrodes in the above embodiment), which are used to form a parallel plate capacitor with the human body and dielectric layers (clothing, air layer, etc.) to couple ECG signals or provide feedback drive signals to the human body. The memory foam and insulating fabric layer are used to isolate the electrodes. The memory foam is also used to conform to the curve of the human body contact surface to ensure the electrode coupling quality. As shown in Figure 6, each electrode is connected to its corresponding flexible conductive fabric blended yarn, which converges at the electrode pad interface at the edge of the electrode and connects to the acquisition circuit system 2.

[0095] The acquisition circuit system 2 can be integrated into the ECG signal acquisition pad 1 or used as a separate device. A switch can also be set in the acquisition circuit system 2 to control the working state of the acquisition circuit system 2.

[0096] The electrocardiogram (ECG) monitoring system provided in this disclosure eliminates the need to attach measuring electrodes to the user's body surface; the user simply needs to lie on an ECG signal acquisition pad, thus enabling long-term monitoring of the user's ECG signals without any sensory impact.

[0097] Furthermore, since the electrodes for collecting ECG signals are not fixed to the user's body surface, the coupling surface between the electrodes and the user's clothing is easily affected by factors such as body movement and fluctuations in body condition, thus affecting the quality of the ECG signals collected by the electrodes. Therefore, when an ECG signal acquisition channel composed of a single electrode collects ECG signals, since only this one ECG signal is ultimately acquired, if the coupling surface corresponding to the electrode that makes up the ECG signal acquisition channel changes, the quality of the ECG signal collected by that electrode will be poor, or even unable to collect an ECG signal at all, which will lead to inaccurate ECG signals in the end. In this disclosure, multiple rows of ECG signal acquisition electrodes are set up, forming multiple ECG signal acquisition channels. During the ECG signal acquisition process, the electrode corresponding to each ECG signal acquisition channel will acquire ECG signals. That is, multiple ECG signals are acquired at this time. When the user experiences body movement or fluctuations in body state, even if the coupling surface corresponding to the electrode in a certain ECG signal acquisition channel changes, causing the quality of the ECG signal acquired by that ECG signal acquisition channel to deteriorate, there are other ECG signal acquisition channels whose coupling surfaces have not changed or whose coupling surfaces have changed in a way that improves the signal quality. The ECG signals acquired by these other ECG signal acquisition channels are still accurate. Since it is not a single ECG signal but multiple ECG signals that are acquired, accurate ECG signals will be included in these ECG signals. Therefore, the problem of inaccurate overall ECG signals acquired due to coupling surface changes caused by body movement and fluctuations in body state will not occur.

[0098] Taking Figure 4 as an example, during the process of acquiring ECG signals through 8 ECG signal acquisition channels, each ECG signal acquisition channel will output ECG signals, that is, 8 ECG signals will be output. These include accurate ECG signals and inaccurate ECG signals. When the user experiences body movement or fluctuations in physical state, for example, when the coupling surface corresponding to the first ECG signal acquisition channel in the first column changes, although the quality of the ECG signal acquired by the first ECG signal acquisition channel in the first column is poor, since there are still 7 ECG signal acquisition channels, there will inevitably be accurate ECG signals among the ECG signals acquired by these 7 ECG signal acquisition channels. Since the output is still 8 ECG signals, the accurate ECG signal can still be found from these 8 ECG signals.

[0099] Furthermore, in this disclosure, because multiple ECG signal acquisition channels are set up, multiple ECG signals corresponding to different locations can be acquired, thereby improving the comprehensiveness of the ECG signals.

[0100] Figure 9 is an exploded view of an electrocardiogram (ECG) signal acquisition pad 1 with the ECG signal acquisition layer 12, inner insulating layer 13, driving electrode layer 14, and second outer insulating layer 15 stacked according to an exemplary embodiment.

[0101] The method for preparing the ECG signal acquisition pad 1 in this disclosure is as follows:

[0102] 1. The silver fiber fabric conductive layer and memory foam of each electrode are heat-pressed together separately.

[0103] 2. Sew the conductive fabric thread to the electrode sensing area.

[0104] 3. From bottom to top, stack the second outer insulating layer 15, the driving electrode layer 14, the inner insulating layer 13, and the ECG signal acquisition layer 12 according to the design dimensions. Place the fabric conductive wire 16 in the position shown in the design drawing, connect one end to the corresponding electrode, and connect the other end to the interface of the ECG signal acquisition pad 1.

[0105] 4. Lay the first outer insulating layer 11 with the electrode positions cut out on the top according to the dimension drawing, as shown in Figure 9.

[0106] 5. Use a large hot press to press the materials of each layer together vertically to form a complete ECG signal acquisition pad 1.

[0107] 6. The first outer insulation layer 11 and the second outer insulation layer 15 are edged with an elastic edge banding strip 17.

[0108] The front view and cross-sectional views of the ECG signal acquisition pad 1 after pressing are shown in Figures 7 and 8. Except for the exposed conductive electrode surfaces, the outer surface of the ECG signal acquisition pad 1 is covered with insulating fabric. Insulating fabric is also used to isolate the electrodes in different layers. These insulating materials can not only isolate the electrical signals between the conductive wires 16 of the fabric and the silver fiber material, but also provide a comfortable lying experience.

[0109] Taking Figure 4 as an example, the exposed electrodes contain 12 smaller signal acquisition electrodes arranged in a three-row, four-column configuration for acquiring electrocardiogram (ECG) signals. From left to right, the first column is numbered CH1-P, CH1-N1, and CH1-N2 from top to bottom; the second column is numbered CH2-P, CH2-N1, and CH2-N2 from top to bottom, and so on. Each column forms two ECG signal acquisition channels, for a total of eight ECG signal acquisition channels. In each column, the top row electrode CHx-P (where x represents any number from 1 to 4) is the positive channel of the differential amplifier, shared by both channels in that column. The second row (CHx-N1) and the third row (CHx-N2) are the negative channels of the differential amplifiers for the two channels, respectively. CHx-P and CHx-N1, and CHx-P and CHx-N2 in each column constitute two sets of potential difference measurement channels (i.e., the ECG signal acquisition channels in this disclosure). The user lies down and adjusts their scapula to the height of the CHx-P electrode to begin measurement. By selecting an ergonomically designed electrode size and longitudinal spacing that conforms to the dimensions of the human limbs and torso, it can be ensured that for most users, after adjusting their position as described above, the lower edge of their ribs is close to at least one of CHx-N1 or CHx-N2. This allows for the measurement of the potential difference between the two positions from the scapula to the lower edge of the ribs, obtaining an ECG signal similar to a traditional two-lead ECG (right hand to left leg). For shorter users, with CHx-N1 closer to their lower ribs, the measurement channel composed of CHx-P and CHx-N1 has a higher probability of obtaining a higher quality two-lead ECG observation. For taller users, with CHx-N2 closer to their lower ribs, the measurement channel composed of CHx-P and CHx-N2 has a higher probability of obtaining a higher quality two-lead ECG observation. Furthermore, by rationally designing the electrode size and longitudinal and lateral spacing, it is ensured that the user's body can cover at least one column of signal acquisition electrodes in any sleeping position. Taking the two columns of signal acquisition electrodes covered in Figures 10-12 as an example, Figure 10 shows a supine sleeping position, where the torso can cover the two columns of channels CH2-P, CH2-N1, CH2-N2 and CH3-P, CH3-N1, CH3-N2 in the middle, as well as part of the columns of channels CH1-P, CH1-N1, CH1-N2 and CH4-P, CH4-N1, CH4-N2 on both sides. Figure 11 shows a right-side sleeping position, where the torso can cover the two columns of channels CH1-P, CH1-N1, CH1-N2 and CH2-P, CH2-N1, CH2-N2 on the right side. Figure 12 shows the left-side sleeping position, where the torso can cover the two columns of channels CH3-P, CH3-N1, CH3-N2 and CH4-P, CH4-N1, CH4-N2 on the left side. This design enables reliable capacitively coupled ECG observation.Beneath the 12 signal acquisition electrodes, there is a driving electrode layer 14 that completely covers the entire measurement area. Its positional relationship with the signal acquisition electrodes, clothing, air layer, and human skin is shown in Figure 13. The driving electrode layer 14 has exposed portions in the intervals between the three rows of measurement electrodes. The driving electrode layer 14 is connected to the output of the driving circuit 211 of the acquisition circuit system 2. Its main functions are: to shield some of the interfering electromagnetic waves from space, especially from below the signal acquisition electrodes, primarily power frequency noise and its harmonics, as well as high-frequency pulse noise from surrounding electrical appliances. Furthermore, the driving circuit 211 averages the potentials of the 12 signal acquisition electrodes to obtain a common-mode interference signal, inverts it, and outputs it to the driving electrode layer 14. The high-frequency component of the inverted common-mode signal is then capacitively coupled back to the human body to cancel out some of the common-mode interference.

[0110] In this disclosure, multiple electrodes are used to increase measurement reliability. By rationally designing the position and size of each electrode, it is ensured that the user's body can cover at least one row of signal acquisition electrodes in any sleeping position.

[0111] The following details the methods for determining the electrode position and dimensions.

[0112] 1. Height of the driving electrode layer 14.

[0113] In one possible implementation, the longitudinal dimension of the driving electrode layer 14 is obtained by subtracting the target perineum height dimension corresponding to the first target population from the target scapula position height (also known as shoulder height) dimension corresponding to the first target population. The longitudinal direction of the driving electrode layer 14 is the height direction of the user lying in the ECG signal acquisition pad 1.

[0114] Taking the standing human posture in Figure 14 as an example, when determining the longitudinal dimension of the driving electrode layer 14 based on the standing human posture in Figure 14, the value of subtracting the perineal height (4.2.5 in Figure 14) from the shoulder height (4.2.2 in Figure 14) is the height of the upper body. Let the shoulder height be a and the perineal height be b, and the value of ab is used as a reference value for the longitudinal dimension of the driving electrode layer 14.

[0115] In another possible implementation, the longitudinal dimension of the driving electrode layer 14 is obtained by subtracting the target perineum height of the female in the first target group from the target scapula height (also known as shoulder height) of the female in the first target group, and subtracting the target perineum height of the male in the first target group from the target shoulder height of the male in the first target group.

[0116] Continuing with Figure 14 as an example, Table 1 shows the standing dimensions of the human body corresponding to the figures in Figure 14. The percentiles in Table 1 represent the percentage of people with a certain body size or smaller than that size among the total number of people surveyed. For example, the 50th percentile for male shoulder height is 1367 mm, meaning that 50% of the males surveyed have a shoulder height less than or equal to 1367 mm. For both men and women, a 1% value is selected for the design. The difference between the 1% shoulder height a1 and the 1% perineal height b1 for men is a1-b1; the difference between the 1% shoulder height a2 and the 1% perineal height b2 for women is a2-b2. Since (a1-b1) > (a2-b2), a2-b2 is chosen as the design dimension. This ensures that the upper body of most users can completely cover the driving electrode layer 14 area longitudinally during use, as shown in Figure 15.

[0117] Table 1

[0118] 2. Width of the driving electrode layer 14.

[0119] In one possible implementation, the lateral dimension of the driving electrode layer 14 is obtained based on the chest thickness and the maximum shoulder width corresponding to the first target population, and the lateral dimension of the driving electrode layer 14 is perpendicular to the longitudinal dimension of the driving electrode layer 14.

[0120] Taking the human body in Figure 16 as an example, during actual sleep, as shown in Figure 17, users not only have a supine sleeping position in the middle, but also a right-side lying position on the left and a left-side lying position on the right. When determining the lateral dimensions of the driving electrode layer based on the horizontal dimensions of the human body in Figure 16, considering the general situation where the torso is located in the middle of the lateral position of the driving electrode layer in a supine state, when turning over to the left or right, the human body rotates 90 degrees to the left and right with the shoulders and upper arms as axes, respectively. Therefore, the sum of twice the chest thickness (4.4.2 in Figure 16) and the maximum shoulder width (4.4.4 in Figure 16) is the lateral range of motion when the user is lying down. Let the chest thickness be c and the maximum shoulder width be d. The value of 2c + d is used as a reference value for the lateral dimensions of the driving electrode layer 14.

[0121] In another possible implementation, the lateral dimension of the driving electrode layer 14 is obtained based on the breast thickness corresponding to women in the first target group, the maximum shoulder width corresponding to women in the first target group, the breast thickness corresponding to men in the first target group, and the maximum shoulder width corresponding to men in the first target group.

[0122] Continuing with Figure 16 as an example, Table 2 shows the horizontal dimensions of the human body corresponding to the figures in Figure 16. For both men and women, the average values ​​of the 50th percentile are selected for design. The sum of the 50th percentile chest thickness c1 and the maximum shoulder width d1 for men is 2c1+d1; the sum of the 50th percentile chest thickness c2 and the maximum shoulder width d2 for women is 2c2+d2. To ensure that the torso of as many users as possible can fully or partially cover the CH1 and CH4 signal acquisition electrodes in supine or side-lying positions, the average of (2c2+d2) and (2c1+d1) is used as the design dimension, as shown in Figure 18.

[0123] Table 2

[0124] 3. The distance between the positive electrode 1211 and the negative electrode 1212.

[0125] The distance between the positive electrode 1211 and the negative electrode 1212 is obtained by subtracting the sitting elbow height of the second target group from the sitting shoulder height of the second target group.

[0126] Taking the human sitting posture in Figure 19 as an example, Table 3 shows the dimensions of the human sitting posture corresponding to the human body in Figure 19. Based on the dimensions of the human sitting posture in Figure 19, the longitudinal dimensions of the first to second and third rows of the signal acquisition electrodes are determined. The value of subtracting the sitting elbow height (4.3.4 in Figure 19) from the sitting shoulder height (4.3.4 in Figure 19) can be regarded as the height from the shoulder to the lower edge of the ribs. The potential difference of the skin surface from the shoulder to the lower edge of the ribs is usually used by Holter for electrocardiograms of leads II and III. The electrodes designed in this disclosure need to acquire the potential difference of the same or similar locations so that the observed signal is close to the conventional electrocardiogram signals of leads II and III. Let the sitting shoulder height be e and the sitting elbow height be f. For men and women, values ​​of 99% and 1% are selected for design, respectively. The difference between 99% sitting shoulder height e1 and 99% sitting elbow height f1 for men is e1-f1; the difference between 1% sitting shoulder height e2 and 1% sitting elbow height f2 for women is e2-f2. Choosing e1-f1 as the electrode spacing between the first and third rows, and e2-f2 as the electrode spacing between the first and second rows, ensures that for the vast majority of users, when lying down, the lower edge of the ribs is located in the area enclosed by the second and third rows of signal acquisition electrodes, i.e., the shaded area in Figure 20. In this way, for the vast majority of users, a signal close to that of conventional II and III lead ECG can be obtained.

[0127] Table 3

[0128] 4. The width of the positive electrode 1211 and the width of the negative electrode 1212.

[0129] The width dimensions of the positive electrode 1211 and / or the width dimensions of the negative electrode 1212 are obtained based on the chest thickness dimensions corresponding to the third target population. The width directions of the positive electrode 1211 and the negative electrode 1212 are perpendicular to the height direction of the user lying on the ECG signal acquisition pad 1.

[0130] The width of each electrode is determined based on the horizontal dimensions of the human body in Figure 16. Since side sleeping is a possibility during actual sleep, it is necessary to ensure that at least one row of signal acquisition electrodes is completely covered when the user is sleeping on their side. Here, the chest thickness (4.4.2) value in Figure 16 is used as a reference value and is set as g. For both men and women, 1% values ​​are selected for the design. For men, 1% chest thickness g1 is greater than for women, g2, where g1 > g2. Selecting g2 ensures that both heavier and thinner users can have at least one row of signal acquisition electrodes completely covered when sleeping on their side, as shown in Figure 21.

[0131] Figure 22 is a circuit diagram corresponding to the ECG signal acquisition pad 1 shown in Figure 4. Taking the circuit shown in Figure 22 as an example, each column of signal processing circuit 212 includes: a positive signal processing circuit 212a corresponding to the positive electrode 1211 in each column, a negative signal processing circuit 212b corresponding to each negative electrode 1212 in each column, and a channel signal processing circuit 212c corresponding to each ECG signal acquisition channel in each column.

[0132] The positive electrode 1211 is connected to the input terminal of the corresponding positive signal processing circuit 212a;

[0133] Each negative electrode 1212 is connected to the input terminal of the corresponding negative signal processing circuit 212b;

[0134] For each ECG signal acquisition channel, the first output terminal of the positive signal processing circuit 212a corresponding to the current ECG signal acquisition channel is connected to the first input terminal of the channel signal processing circuit 212c corresponding to the current ECG signal acquisition channel, and the first output terminal of the negative signal processing circuit 212b corresponding to the current ECG signal acquisition channel is connected to the second input terminal of the channel signal processing circuit 212c corresponding to the current ECG signal acquisition channel.

[0135] The output of the channel signal processing circuit 212c corresponding to each ECG signal acquisition channel is connected to the storage module 221;

[0136] The second output terminals of all positive signal processing circuits 212a and all negative signal processing circuits 212b are connected to the input terminal of the drive circuit 211.

[0137] In one embodiment, each positive signal processing circuit 212a includes: a positive buffer, a positive resistor, and a positive filter;

[0138] The positive electrode 1211 corresponding to the current ECG signal acquisition channel is connected to the input terminal of the positive buffer corresponding to the current ECG signal acquisition channel. The output terminal of the positive buffer corresponding to the current ECG signal acquisition channel is connected to the first terminal of the positive resistor corresponding to the current ECG signal acquisition channel and the input terminal of the positive filter corresponding to the current ECG signal acquisition channel, respectively.

[0139] Each negative signal processing circuit 212b includes: a negative buffer, a negative resistor, and a negative filter;

[0140] The negative electrode 1212 corresponding to the current ECG signal acquisition channel is connected to the input terminal of the negative buffer corresponding to the current ECG signal acquisition channel. The output terminal of the negative buffer corresponding to the current ECG signal acquisition channel is connected to the first terminal of the negative resistor corresponding to the current ECG signal acquisition channel and the input terminal of the negative filter corresponding to the current ECG signal acquisition channel, respectively.

[0141] Each channel signal processing circuit 212c includes: an amplifier and an analog-to-digital converter (ADC);

[0142] The output terminal of the positive filter corresponding to the current ECG signal acquisition channel is connected to the first input terminal of the amplifier corresponding to the current ECG signal acquisition channel; the output terminal of the negative filter corresponding to the current ECG signal acquisition channel is connected to the second input terminal of the amplifier corresponding to the current ECG signal acquisition channel; the output terminal of the amplifier corresponding to the current ECG signal acquisition channel is connected to the input terminal of the analog-to-digital converter corresponding to the current ECG signal acquisition channel.

[0143] The output of each analog-to-digital converter is connected to the storage module 221;

[0144] The second terminal of all positive resistors and the second terminal of all negative resistors are connected to the input terminal of drive circuit 211.

[0145] The positive and negative filters can be implemented using RC filter circuits, and the amplifier can include a programmable amplifier (PGA).

[0146] The positive signal processing circuit 212a, negative signal processing circuit 212b, channel signal processing circuit 212c and driving circuit 211 in the above embodiment constitute the analog front end 21 of the acquisition system. The analog front end 21 is connected to the output interface of the ECG signal acquisition pad 1, and performs buffering, filtering, amplification and digital processing on the analog signal acquired by the ECG signal acquisition pad 1, extracts common mode noise, inverts it and feeds it back to the human body.

[0147] To improve the signal-to-noise ratio, the input impedance of a small-signal amplifier should be much greater than the output impedance at the signal source. However, because the ECG signal source in capacitively coupled ECG measurement is coupled through the equivalent capacitance of the air layer in clothing, the signal source impedance seen from the electrodes is relatively large. Directly connecting the signal to a conventional differential amplifier may not meet the measurement requirements. Therefore, a buffer is needed to buffer each coupled ECG signal to reduce the equivalent output impedance of the signal source. In this disclosure, a voltage follower is composed of a precision amplifier (e.g., AD8608) with low noise, high gain-bandwidth product, low bias voltage, and small input bias current to buffer the input signals of each measurement electrode. Each input signal is then passed through a first-order RC anti-aliasing filter to meet the sampling requirements of the subsequent digital-to-analog converter (ADC).

[0148] Next, taking Figure 22 as an example, for each column of ECG signal acquisition electrodes, the buffered and filtered CHx-P (first row) and CHx-N1 (second row), and CHx-P and CHx-N2 (third row) are respectively used as the positive and negative inputs of a differential programmable gain amplifier (PGA) for differential signal amplification by a preset factor. Because the input signal is buffered in advance, the equivalent output impedance is reduced, requiring only a PGA with a normal input impedance level to complete high signal-to-noise signal amplification. The signals from the two analog channels formed by each column of ECG signal acquisition electrodes are amplified, generating a total of eight channels of amplifier analog outputs, which are input to their respective analog-to-digital converters (ADCs) for quantization. The digital outputs of each ADC channel are connected to the SPI bus.

[0149] After the signals acquired by each electrode pass through a buffer, another circuit branch isolates each signal through a large resistor (the positive and negative resistors in the above embodiment) and then short-circuits them to average them. This average value is the common-mode signal, which is input to the driving circuit 211. The driving circuit 211 uses an inverting amplifier to output an inverted common-mode voltage (i.e., the driving voltage). The driving voltage is connected to the driving electrode layer 14 covering the entire measurement area and is output in reverse to the human body through the capacitive coupling path of electrode-clothing and air layer-skin to cancel out some of the common-mode noise interference. It should be noted that, unlike the right leg driving voltage in traditional ECG measurements where the electrodes are in direct contact with the skin, in this disclosure, the driving voltage feedback loop can be equivalent to an RC high-pass filter. Therefore, only the higher frequency common-mode signal components can be fed back (e.g., power frequency noise and high-frequency interference), while the lower frequency quasi-DC components are difficult to pass through. As a result, there will still be a large DC bias voltage and low-frequency noise in ECG sampling. These noises need to be further processed in the digital system part of the acquisition circuit and the host computer part.

[0150] In the circuit described above, the PGA, ADC, and driver circuitry can be implemented using discrete components or integrated analog front-ends such as the ADS1298. Generally, using integrated analog front-ends can achieve higher channel consistency.

[0151] In one embodiment, as shown in FIG23, the acquisition system further includes: a power module 31;

[0152] The power module 31 includes: a battery 311 and a charging circuit 312;

[0153] The current output terminal of battery 311 is connected to drive circuit 211, storage module 221 and each signal processing circuit 212 respectively;

[0154] The current input terminal of battery 311 is connected to charging circuit 312.

[0155] Among them, battery 311 can be a lithium battery, and charging circuit 312 can be implemented by an integrated charging management chip (such as TP4056).

[0156] Specifically, the ECG monitoring system in this disclosure can be powered by a lithium battery to isolate power frequency interference from the mains network and achieve high signal-to-noise ratio sampling. The current output terminal of the lithium battery is connected to the analog front-end 21 and the storage module 221 to provide power to the analog front-end 21 and the storage module 221. An integrated charging management chip (e.g., TP4056) is connected to a standard USB Type-C 5V power supply interface to control the charging process of the battery 311.

[0157] In one embodiment, as shown in FIG23, the acquisition system further includes: an isolator 41;

[0158] Isolator 41 includes: an isolation power supply 411 and a digital isolator 412;

[0159] One end of the isolation power supply 411 is connected to the drive circuit 211 and each signal processing circuit 212 respectively;

[0160] The other end of the isolation power supply 411 is connected to the current output terminal of the battery 311;

[0161] The input terminal of the digital isolator 412 is connected to the second output terminal of the signal processing circuit 212;

[0162] The output of the digital isolator 412 is connected to the storage module 221.

[0163] Since this acquisition circuit system 2 is used in clinical settings, it needs to meet the electrical isolation requirements related to medical devices. Therefore, the analog front-end 21 is isolated from other parts using an isolator 41, which mainly includes power isolation and digital signal isolation. Power isolation is achieved through an isolation power supply 411, and digital signal isolation is achieved through a digital isolator 412. In some embodiments, a discrete isolation power supply 411 is used to isolate the output of the 3.7V battery 311 and convert it to the 3.3V voltage required by the analog front-end 21. A silicon-based digital isolator 412 is used to isolate the digital input / output chip and isolate the SPI bus, allowing the ADC to be connected to the storage module 221. The current output terminal of the battery 311 is connected to the analog front-end 21 through the isolation power supply 411. In other applications, a digital signal isolator 412 with integrated isolation power supply 411 functionality, such as the CA-IS3641, can also be used to implement the aforementioned isolator 41.

[0164] In one embodiment, as shown in FIG23, the digital processing and storage circuit 22 further includes: a linear regulator 222, a microcontroller (MCU) 223, and a WiFi network card 224;

[0165] The current output terminal of battery 311 is connected to the input terminal of linear regulator 222;

[0166] The output terminal of the linear regulator 222 is connected to the first terminal of the microcontroller 223, the first terminal of the storage module 221, and the first terminal of the WiFi network card 224, respectively.

[0167] The output of digital isolator 412 is connected to the second terminal of microcontroller 223;

[0168] The third terminal of the microcontroller 223 is connected to the second terminal of the WiFi network card 224;

[0169] The fourth terminal of the microcontroller 223 is connected to the second terminal of the storage module 221.

[0170] For example, storage module 221 may include a memory card, such as a TF card.

[0171] The storage module 221 in the above embodiments can also be referred to as a digital processing circuit. The linear regulator 222 (e.g., TPS73733) can convert the battery voltage 311 to the 3.3V output voltage required by other devices in the digital processing circuit. The MCU reads the ECG signal data converted by the ADC via the SPI bus, performs bandpass filtering on the read ECG signal data using the FIR filter integrated in the MCU to remove out-of-band noise, and stores the processed data in the TF card. Furthermore, the MCU is connected to the WiFi network card 224 via the UART bus. In this disclosure, the WiFi network card 224 can be configured to connect to a TCP or UDP server running on the host computer via a router as shown in Figure 6 to receive sampling start commands, sampling end commands, PGA configuration parameters, and ADC configuration parameters from the host computer, and upload the collected data.

[0172] When the host computer includes a server and a display device, after the host computer is powered on, the server in the host computer establishes a TCP service listener, so that it can automatically connect to the acquisition circuit system 2 after it is powered on via WiFi, so that data can be transmitted between the host computer and the acquisition circuit system 2.

[0173] Specifically, WiFi network card 224 is connected to the router wirelessly, and the host computer is connected to the router via wired or wireless means. The router is responsible for forwarding TCP or UDP data packets sent between the host computer and the acquisition circuit system 2.

[0174] It is worth noting that the electrocardiogram monitoring system in this disclosure can be applied to scenarios such as the following:

[0175] (1) Cardiovascular diseases: continuous screening of key populations, home diagnosis, continuous monitoring in wards, and home monitoring and assessment of prognosis;

[0176] (2) Neurology: routine screening for sleep-disordered breathing (e.g., sleep apnea, which will cause abnormal changes in electrocardiogram), assessment and diagnosis of mental illness;

[0177] (3) Infant and young child health: Monitoring of vital signs during sleep in newborns and infants.

[0178] When using the ECG monitoring system of this disclosure, the ECG signal acquisition pad 1 is placed on the surface of a regular mattress, such as a memory foam mattress, a spring mattress, or a palm mattress. The user chooses whether to wear pajamas to sleep according to their daily sleeping habits, and lies on the ECG signal acquisition pad 1 in a comfortable position, adjusting the position of the ECG signal acquisition pad 1 so that the scapula area is covered by any one of the positive electrodes 1211.

[0179] Connect the ECG signal acquisition pad 1 to the acquisition circuit system 2. After the connection is complete, turn on the switch of the acquisition circuit system 2 and the host computer. The Wi-Fi in the acquisition circuit system 2 will automatically turn on and attempt to wirelessly connect with the host computer to complete the connection between the acquisition circuit system 2 and the host computer. After the connection is successful, the signal waveform and heart rate information will be displayed in real time on the display device of the host computer.

[0180] After the user lies on the ECG signal acquisition pad 1, the acquisition circuit system 2 acquires ECG signals from each channel and sends the ECG signals to the host computer. The host computer uses an automatic ECG quality assessment system to score the signal quality of each channel, automatically selects ECG channels that meet clinical standards, calculates cardiac activity indicators such as heart rate, and displays the labeled scores, signal waveforms, and heart rate information in real time on the host computer's display device.

[0181] When in use, regular bedding such as sheets and fitted sheets can be laid on the surface of the ECG signal acquisition pad 1, which will not affect the user's sleep habits and can also protect the exposed electrodes in the electrode pad.

[0182] When using the ECG monitoring system disclosed herein, the user can lie in bed fully clothed, and the potential difference at the corresponding location on their torso can be collected. After processing, an ECG signal can be obtained. The user is asleep and completely unaffected by the measuring instrument. They can freely turn over in bed without the constraints of wiring. The user does not need to pay attention to the system or maintain a fixed sleeping position. Regardless of the sleeping position, the system will select the high-signal-quality channel for recording.

[0183] Compared with existing methods, its advantages are:

[0184] (1) The layered flexible electrode pads ensure better fit to the body and superior signal quality;

[0185] (2) It can measure ECG through multiple channels, covering various sleep postures of users rather than only being able to measure in a fixed position and posture;

[0186] (3) Automatically assess signal quality and select channels that meet clinical requirements, and can directly provide clinical-grade ECG monitoring that includes diagnostic details, not just heart rate.

[0187] Since the electrodes in the ECG monitoring system of this disclosure can measure ECG signals through clothing instead of directly contacting the skin, the ECG signal acquisition pad 1 of this disclosure is an alternative form. In practical scenarios, the ECG signal acquisition pad 1 can be not only a mattress, but also a cushion or other product.

[0188] Based on the ECG monitoring system described in the embodiment corresponding to Figure 1, this disclosure also provides an ECG monitoring method. This method is applied to the ECG signal acquisition pad in the above embodiment. For details of the specific implementation, please refer to the description of the above embodiment, which will not be repeated here.

[0189] Based on the ECG monitoring system described in the embodiment corresponding to Figure 2, this disclosure also provides an ECG monitoring method. This method is applied to the acquisition circuit system in the above embodiment. For details of the specific implementation, please refer to the description of the above embodiment, which will not be repeated here.

[0190] Based on the electrocardiogram (ECG) monitoring system described in the above embodiments, this disclosure also provides an ECG monitoring method. This method is applied to the host computer in the above embodiments, and the specific implementation is detailed in the above embodiments, which will not be repeated here.

[0191] Based on the ECG monitoring method corresponding to the aforementioned ECG signal acquisition pad, this disclosure also provides an ECG monitoring device that can be used to execute the method embodiments of this disclosure. Based on the ECG monitoring method corresponding to the aforementioned acquisition circuit system, this disclosure also provides an ECG monitoring device that can be used to execute the method embodiments of this disclosure. Based on the ECG monitoring method corresponding to the aforementioned host computer, this disclosure also provides an ECG monitoring device that can be used to execute the method embodiments of this disclosure.

[0192] The technical features of the above embodiments can be combined arbitrarily. For the sake of brevity, not all possible combinations of the technical features in the above embodiments are described. However, as long as the combination of these technical features does not contradict each other, it should be considered within the scope of this specification. Specific examples have been used to illustrate the principles and implementation methods of this application. The descriptions of the above embodiments are only for the purpose of helping to understand the method and core ideas of this application. Furthermore, those skilled in the art will recognize that, based on the ideas of this application, there will be changes in the specific implementation methods and application scope. Therefore, the content of this specification should not be construed as a limitation of this application.

Claims

1. A cardiac electrical monitoring system, characterized by, The electrocardio monitoring system comprises: an electrocardio signal collecting pad and collecting circuit system; the electrocardio signal collecting pad comprises: a first external insulation layer, an electrocardio signal collecting layer, an internal insulation layer, a driving electrode layer and a second external insulation layer which are stacked from top to bottom; the electrocardio signal collecting layer comprises: a plurality of columns of electrocardio signal collecting electrodes; each column of the electrocardio signal collecting electrodes comprises: one positive electrode and a plurality of negative electrodes; the positive electrode is arranged close to a first position in the electrocardio signal collecting pad, the first position is a position corresponding to a scapula of a user lying on the electrocardio signal collecting pad, a first negative electrode is arranged at a preset distance from the positive electrode, and other negative electrodes are arranged in sequence after the first negative electrode, so that when the user lies on the electrocardio signal collecting pad, the positive electrode is close to the position of the user's scapula, and at least one negative electrode is close to the position of the user's lower edge of the rib; the collecting circuit system comprises: an analog front end and a digital processing and storage circuit; the analog front end comprises: a driving circuit and a signal processing circuit corresponding to each column of the electrocardio signal collecting electrodes; the digital processing and storage circuit comprises: a storage module; an input end of the driving circuit is connected with a first output end of each signal processing circuit, an output end of the driving circuit is connected with the driving electrode layer; the positive electrode and the negative electrodes in each column of the electrocardio signal collecting electrodes are connected with the input end of the corresponding signal processing circuit, and in each column of the electrocardio signal collecting electrodes, the positive electrode and each negative electrode form an electrocardio signal collecting channel; a second output end of the signal processing circuit is connected with the storage module, and the signal processing circuit is used for preprocessing the electrocardio signals collected by each electrocardio signal collecting channel and sending the preprocessed electrocardio signals to the storage module for storage.

2. The cardiac electrical monitoring system of claim 1, wherein, The size of the driving electrode layer is greater than the size of the electrocardio signal collecting layer and less than or equal to the size of the first external insulation layer.

3. The electrocardio monitoring system according to claim 1, wherein the signal processing circuit is further used for evaluating the quality score of the electrocardio signals collected by each electrocardio signal collecting channel after preprocessing and sending the quality score of each electrocardio signal to the storage module for storage.

4. The cardiac electrical monitoring system of claim 1, wherein, The electrocardio monitoring system further comprises: a host computer; the second output end of the signal processing circuit is further connected with the host computer, and the signal processing circuit is used for sending the electrocardio signals collected by each electrocardio signal collecting channel after preprocessing to the host computer; the host computer is used for displaying the electrocardio signals through a display device in the host computer.

5. The electrocardio monitoring system according to claim 4, wherein The upper computer is configured to evaluate a quality score of each of the preprocessed electrocardio signals collected by each of the electrocardio signal collection channels, obtain a target electrocardio signal with a quality score greater than a preset score, calculate a heart activity index based on the target electrocardio signal, and output each of the electrocardio signals, the quality score of each of the electrocardio signals, and the heart activity index via the display device.

6. The cardiac electrical monitoring system of claim 1, wherein, The driving electrode layer, the positive electrode, and the negative electrode each include a protection layer and a silver fiber fabric conductive layer made of silver fiber fabric conductive material, which are stacked from bottom to top. 7.The electrocardio monitoring system of claim 1, wherein, The positive electrode and the negative electrode are connected to the corresponding signal processing circuit through conductive wires. The output end of the driving circuit is connected to the driving electrode layer through the conductive wires. 8.The electrocardio monitoring system of claim 1, wherein, The longitudinal dimension of the driving electrode layer is obtained by subtracting a target perineum height corresponding to the first target population from a target scapula position height corresponding to the first target population, and the longitudinal direction of the driving electrode layer is the height direction of the user lying on the electrocardio signal collection pad. The transverse dimension of the driving electrode layer is obtained by subtracting a maximum shoulder width corresponding to the first target population from a chest thickness corresponding to the first target population, and the transverse direction of the driving electrode layer is perpendicular to the longitudinal direction of the driving electrode layer. 9.The electrocardio monitoring system of claim 8, wherein, The longitudinal dimension of the driving electrode layer is obtained by subtracting a target perineum height corresponding to the female in the first target population from a target scapula position height corresponding to the female in the first target population, and subtracting a target perineum height corresponding to the male in the first target population from a target scapula position height corresponding to the male in the first target population; The transverse dimension of the driving electrode layer is obtained by subtracting a maximum shoulder width corresponding to the female in the first target population from a chest thickness corresponding to the female in the first target population, subtracting a maximum shoulder width corresponding to the male in the first target population from a chest thickness corresponding to the male in the first target population. 10.The electrocardio monitoring system of claim 1, wherein, The distance between the positive electrode and the negative electrode is obtained by subtracting an elbow height corresponding to the second target population in a sitting position from a shoulder height corresponding to the second target population in a sitting position. 11.The electrocardio monitoring system of claim 1, wherein, The width dimension of the positive electrode and / or the width dimension of the negative electrode is obtained by a chest thickness corresponding to the third target population, and the width direction of the positive electrode and the width direction of the negative electrode are perpendicular to the height direction of the user lying on the electrocardio signal collection pad.

12. The cardiac electrical monitoring system of claim 1, wherein, Each column of the signal processing circuit includes: The positive electrode signal processing circuit corresponding to each positive electrode in each column, the negative electrode signal processing circuit corresponding to each negative electrode in each column, and the channel signal processing circuit corresponding to each ECG signal acquisition channel in each column; The positive electrode is connected with the input end of the corresponding positive electrode signal processing circuit; Each negative electrode is connected with the input end of the corresponding negative electrode signal processing circuit; For each ECG signal acquisition channel, the first output end of the positive electrode signal processing circuit corresponding to the current ECG signal acquisition channel is connected with the first input end of the channel signal processing circuit corresponding to the current ECG signal acquisition channel, and the first output end of the negative electrode signal processing circuit corresponding to the current ECG signal acquisition channel is connected with the second input end of the channel signal processing circuit corresponding to the current ECG signal acquisition channel; The output end of the channel signal processing circuit corresponding to each ECG signal acquisition channel is connected with the storage module; The second output end of all the positive electrode signal processing circuits and the second output end of all the negative electrode signal processing circuits are connected with the input end of the driving circuit.

13. The ECG monitoring system according to claim 12, wherein, Each positive electrode signal processing circuit comprises a positive electrode buffer, a positive electrode resistor and a positive electrode filter; the positive electrode corresponding to the current ECG signal acquisition channel is connected with the input end of the positive electrode buffer corresponding to the current ECG signal acquisition channel, and the output end of the positive electrode buffer corresponding to the current ECG signal acquisition channel is connected with the first end of the positive electrode resistor corresponding to the current ECG signal acquisition channel and the input end of the positive electrode filter corresponding to the current ECG signal acquisition channel, respectively; Each negative electrode signal processing circuit comprises a negative electrode buffer, a negative electrode resistor and a negative electrode filter; The negative electrode corresponding to the current ECG signal acquisition channel is connected with the input end of the negative electrode buffer corresponding to the current ECG signal acquisition channel, and the output end of the negative electrode buffer corresponding to the current ECG signal acquisition channel is connected with the first end of the negative electrode resistor corresponding to the current ECG signal acquisition channel and the input end of the negative electrode filter corresponding to the current ECG signal acquisition channel, respectively; Each channel signal processing circuit comprises an amplifier and an analog-to-digital converter; The output end of the positive electrode filter corresponding to the current ECG signal acquisition channel is connected with the first input end of the amplifier corresponding to the current ECG signal acquisition channel, and the output end of the negative electrode filter corresponding to the current ECG signal acquisition channel is connected with the second input end of the amplifier corresponding to the current ECG signal acquisition channel; the output end of the amplifier corresponding to the current ECG signal acquisition channel is connected with the input end of the analog-to-digital converter corresponding to the current ECG signal acquisition channel; The output end of each analog-to-digital converter is connected with the storage module; The second end of all the positive electrode resistors and the second end of all the negative electrode resistors are connected with the input end of the driving circuit.

14. The cardiac electrical monitoring system of claim 1, wherein, The acquisition system further comprises a power module; The power module comprises a battery and a charging circuit; Current output ends of the battery are connected with the driving circuit, the storage module and each of the signal processing circuits respectively; A current input end of the battery is connected with the charging circuit.

15. The cardiac electrical monitoring system of claim 14, wherein, The acquisition system further comprises an isolator; The isolator comprises an isolated power supply and a digital isolator; one end of the isolated power supply is connected with the driving circuit and each of the signal processing circuits respectively; the other end of the isolated power supply is connected with the current output end of the battery; an input end of the digital isolator is connected with the second output end of the signal processing circuit; an output end of the digital isolator is connected with the storage module.

16. The electrocardio monitoring system according to claim 15, characterized in that, The digital processing and storage circuit further comprises a linear voltage stabilizer, a microcontroller and a WiFi card; The current output end of the battery is connected with an input end of the linear voltage stabilizer; an output end of the linear voltage stabilizer is connected with a first end of the microcontroller, a first end of the storage module and a first end of the WiFi card respectively; an output end of the digital isolator is connected with a second end of the microcontroller; a third end of the microcontroller is connected with a second end of the WiFi card; a fourth end of the microcontroller is connected with a second end of the storage module.

17. The cardiac electrical monitoring system of any of claims 1-16, wherein, The first outer insulation layer and the second outer insulation layer are peripherally wrapped with a binding strip.

18. The cardiac electrical monitoring system of any of claims 1-16, wherein, In the first outer insulation layer, a hollow structure is arranged at positions corresponding to the positive electrode, positions corresponding to the negative electrode, positions between the positive electrode and the negative electrode, and positions between two adjacent rows of the negative electrode.

19. The cardiac electrical monitoring system of any of claims 1-16, wherein, The first outer insulation layer, the inner insulation layer and the second outer insulation layer are all made of insulating fabric.

20. The cardiac electrical monitoring system of claim 7, wherein, The conductive wire comprises a fabric conductive wire.

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