An electrocardiogram monitoring sensor system

Abstract

The present disclosure relates to the technical field of electrocardio monitoring, and particularly relates to an electrocardio monitoring sensing system, comprising: an electrocardio recorder, an electrocardio lead wire and a data acquisition unit, the data acquisition unit is used for acquiring electrocardio signals through multiple electrodes in a first time window, acquiring response voltage of the second electrode after injecting an excitation signal in a second time window, and acquiring polarization voltage of the multiple electrodes in a sampling gap of the electrocardio signals respectively; a processing unit of the electrocardio recorder is used for outputting an electrocardiogram based on the electrocardio signals, obtaining an electrode connection result based on at least the polarization voltage, the alternating current signal and the response voltage, and controlling an LED indicator light to flash and prompt in a color corresponding to a target electrode in a case that the electrode connection result represents a situation that the target electrode is off. Thus, the connection of each electrode can be detected in the electrocardio monitoring process, so that the cause of lead off can be automatically found, and the electrocardio monitoring efficiency is improved.

Description

Technical Field

[0001] This disclosure relates to the field of electrocardiogram (ECG) monitoring technology, specifically to an ECG monitoring sensing system. Background Technology

[0002] Electrocardiogram (ECG) monitoring is a method of monitoring the electrical activity of the heart in real time through electrodes and instruments. Its core function is to continuously record ECG waveforms and provide timely warnings of abnormal signals through an alarm system.

[0003] In related technologies, electrocardiogram monitors usually only trigger an alarm for "lead detachment". To distinguish whether the cause of lead detachment is a problem with a single electrode or a circuit problem, it is necessary to manually observe the signal on the screen to make a judgment, which is prone to errors and has low efficiency. Summary of the Invention

[0004] To overcome the problems existing in the related technologies, this disclosure provides an electrocardiogram monitoring sensing system to solve the defects in the related technologies.

[0005] According to an embodiment of this disclosure, an electrocardiogram (ECG) monitoring sensing system is provided, including an ECG recorder, ECG leads, and a data acquisition unit. The ECG recorder includes an LED indicator, a processing unit, and a push-pull self-locking interface for connecting the ECG leads. The data acquisition unit is connected to the ECG recorder through the ECG leads and the push-pull self-locking interface.

[0006] The data acquisition unit is used to acquire electrocardiogram (ECG) signals through multiple electrodes in contact with the skin of the target object within a first time window, acquire the response voltage of the second electrode after an excitation signal is injected into the first electrode within a second time window, and acquire the polarization voltage of the multiple electrodes respectively during the sampling interval of the ECG signals. The first electrode is an RL electrode placed on the right abdomen of the target object, and the second electrode is other electrodes among the multiple electrodes besides the first electrode.

[0007] The processing unit is configured to output the electrocardiogram of the target object based on the electrocardiogram signal, determine the polarization voltage change value between electrodes based on the polarization voltage, determine the impedance phase angle of the second electrode based on the AC signal and the response voltage, perform electrode connection detection based at least on the polarization voltage change value and the impedance phase angle, obtain the electrode connection result, and control the LED indicator to flash according to the color corresponding to the target electrode if the electrode connection result indicates that the target electrode has detached.

[0008] In one embodiment, a Hall sensor is provided inside the push-pull self-locking interface, and the Hall sensor is used to detect the Hall voltage after the push-pull self-locking interface is connected to the ECG lead wire;

[0009] The processing unit is used to determine the magnetic interface displacement of the ECG lead and the push-pull self-locking interface based on the Hall voltage, and to determine the engagement status of the ECG lead and the push-pull self-locking interface based on the numerical relationship between the magnetic interface displacement and a preset displacement threshold, and to perform electrode connection detection based on the engagement status, the polarization voltage change value and the impedance phase angle.

[0010] In one embodiment, the processing unit is configured to determine a first connection value based on the fastening condition, a second connection value based on the polarization voltage and the polarization voltage change value, a third connection value based on the impedance phase angle, perform a weighted summation of the first connection value, the second connection value and the third connection value based on a preset weight to obtain a fusion weight value, and obtain an electrode connection result based on the numerical relationship between the fusion weight value and a preset weight threshold.

[0011] The first connection value, the second connection value, and the third connection value are all 0 or 1. A value of 0 indicates a normal connection, while a value of 1 indicates an abnormal connection.

[0012] In one embodiment, the plurality of electrodes further includes an RA electrode for placement on the right shoulder side below the clavicle of the target object, an LA electrode for placement on the left shoulder side below the clavicle of the target object, and an LL electrode for placement on the left abdomen of the target object;

[0013] The processing unit is used to take the absolute difference of polarization voltage between the RA electrode and the LL electrode as the upper limb voltage change value, and the absolute difference of polarization voltage between the LA electrode and the RL electrode as the lower limb voltage change value. Based on the changes in the upper limb voltage change value, the lower limb voltage change value, and the polarization voltage of a single electrode among the multiple electrodes within a preset time period, the electrode connection is detected to obtain a second connection value.

[0014] In one embodiment, the processing unit is configured to determine the third connection value as 1 when the impedance phase angle is less than a first preset angle threshold or the impedance phase angle is greater than a second preset angle threshold, and to determine the third connection value as 0 when the difference between the impedance phase angle and the third preset angle threshold is less than a preset angle difference.

[0015] Wherein, the first preset angle threshold is less than the second preset angle threshold, and the third preset angle threshold is greater than the first preset angle threshold and less than the second preset angle threshold.

[0016] In one embodiment, the data acquisition unit further includes an accelerometer for detecting the motion state of the target object;

[0017] The processing unit is used to increase the preset displacement threshold when the motion state indicates that the target object is in motion, and to restore the preset displacement threshold to the default initial value when the motion state indicates that the target object has stopped moving.

[0018] In one embodiment, the data acquisition unit includes a disposable wearable electrocardiogram sensor;

[0019] The wearable ECG sensor has a built-in power supply and is used to collect ECG signals through the multiple electrodes within the first time window.

[0020] In one embodiment, the processing unit is further configured to, when the electrode connection result indicates that the target electrode has detached, control the analog-to-digital converter in the data acquisition unit to switch from a first acquisition mode to a second acquisition mode, and after the target electrode is reconnected, control the analog-to-digital converter in the data acquisition unit to return from the second acquisition mode to the first acquisition mode, wherein the sampling rate of the second acquisition mode is higher than that of the first acquisition mode.

[0021] In one embodiment, the processing unit is further configured to, when the electrode connection result indicates that the target electrode has detached, perform downgrade control on the working mode of the electrocardiogram recorder according to the detachment status of the target electrode, wherein the working modes of the electrocardiogram recorder include ST mode, monitoring mode and deep filtering mode, the working level of ST mode is higher than that of monitoring mode, and the working level of monitoring mode is higher than that of deep filtering mode.

[0022] In one embodiment, the processing unit is configured to control the working mode of the electrocardiogram recorder to switch to the monitoring mode when there is one target electrode and the working mode of the electrocardiogram recorder is ST mode, and to control the working mode of the electrocardiogram recorder to switch to the deep filtering mode when there are two or more target electrodes and the working mode of the electrocardiogram recorder is monitoring mode.

[0023] The technical solutions provided by the embodiments of this disclosure may include the following beneficial effects:

[0024] The electrocardiogram (ECG) monitoring sensing system provided in this embodiment includes an ECG recorder, ECG leads, and a data acquisition unit. The ECG recorder includes LED indicators, a processing unit, and a push-pull self-locking interface for connecting the ECG leads. The data acquisition unit can acquire ECG signals, response voltages, and polarization voltages. The processing unit can output an ECG based on the ECG signals and perform electrode connection detection based on the polarization voltages and response voltages. Therefore, during ECG monitoring, connection detection of each electrode can be performed, automatically identifying the cause of lead detachment, reducing manual judgment of the cause of lead detachment, and thus improving ECG monitoring efficiency. Furthermore, the polarization voltage change value can locate abnormal electrodes, and the impedance phase angle can reflect the electrical contact between the electrode and the skin surface. Therefore, combining the polarization voltage change value and the impedance phase angle for electrode connection detection can not only accurately locate the cause of lead detachment to a single electrode but also improve detection efficiency and accuracy, reducing false alarms. Attached Figure Description

[0025] The accompanying drawings, which are incorporated in and form a part of this specification, illustrate embodiments consistent with this disclosure and, together with the description, serve to explain the principles of this disclosure.

[0026] Figure 1 This is a schematic diagram of the structure of an electrocardiogram monitoring sensing system shown in an exemplary embodiment of the present disclosure;

[0027] Figure 2 This is a schematic diagram illustrating the electrode positions of an exemplary embodiment of an electrocardiogram monitoring sensing system disclosed herein;

[0028] Figure 3 This is a schematic diagram of the electrocardiogram interface of an electrocardiogram monitoring sensor system, which is an exemplary embodiment of the present disclosure.

[0029] Figure 4 This is an exemplary embodiment of the present disclosure illustrating the driving and installation diagram of an electrocardiogram monitoring sensor system;

[0030] Figure 5 This is a schematic diagram illustrating a Bluetooth connection of an electrocardiogram monitoring sensor system, as shown in an exemplary embodiment of this disclosure.

[0031] Figure 6 This is a schematic diagram illustrating a Bluetooth connection of an electrocardiogram monitoring sensor system, as shown in an exemplary embodiment of this disclosure.

[0032] Figure 7 This is a schematic diagram illustrating a Bluetooth connection of an electrocardiogram monitoring sensor system, as shown in an exemplary embodiment of this disclosure.

[0033] Figure 8 This is an exemplary embodiment of the present disclosure illustrating the electrocardiogram interface of the electrocardiogram monitoring sensor system after Bluetooth connection. Detailed Implementation

[0034] Exemplary embodiments will now be described in detail, examples of which are illustrated in the accompanying drawings. When the following description relates to the drawings, unless otherwise indicated, the same numerals in different drawings denote the same or similar elements. The embodiments described in the following exemplary embodiments do not represent all embodiments consistent with this disclosure. Rather, they are merely examples of apparatuses and methods consistent with some aspects of this disclosure.

[0035] The terminology used in this disclosure is for the purpose of describing particular embodiments only and is not intended to be limiting of the disclosure. The singular forms “a,” “the,” and “the” used in this disclosure are also intended to include the plural forms unless the context clearly indicates otherwise.

[0036] It should be understood that although the terms first, second, third, etc., may be used in this disclosure to describe various information, such information should not be limited to these terms. These terms are only used to distinguish information of the same type from one another. For example, without departing from the scope of this disclosure, first information may also be referred to as second information, and similarly, second information may also be referred to as first information.

[0037] As mentioned in the background section, in related technologies, ECG monitors typically only trigger an alarm for "lead detachment." To distinguish whether the lead detachment is caused by a problem with a single electrode or a wiring issue, manual observation of the signal display on the screen is required. Specifically, single electrode detachment usually leads to abnormalities in multiple leads simultaneously. If multiple leads (especially limb leads) report errors at the same time, it is highly likely that a common electrode among these leads has detached. Therefore, by manually observing the lead signal display on the screen, it is possible to infer which specific limb electrode is malfunctioning. However, this manual judgment method is prone to errors and is inefficient.

[0038] Based on this, at least one embodiment of this disclosure provides an electrocardiogram (ECG) monitoring sensing system, please refer to the appendix. Figure 1 The diagram shows the structure of an electrocardiogram (ECG) monitoring and sensing system 100, which includes an ECG recorder 101, ECG leads 102, and a data acquisition unit 103. The ECG recorder 101 includes an LED indicator 1011, a processing unit 1012, and a push-pull self-locking interface 1013 for connecting the ECG leads 102. The data acquisition unit 103 is connected to the ECG recorder 101 through the ECG leads 102 and the push-pull self-locking interface 1013.

[0039] The data acquisition unit 103 is used to acquire electrocardiogram (ECG) signals through multiple electrodes in contact with the skin of the target object within a first time window, acquire the response voltage of the second electrode after an excitation signal is injected into the first electrode within a second time window, and acquire the polarization voltage of the multiple electrodes during the sampling interval of the ECG signals. The first electrode is an RL electrode placed on the right abdomen of the target object, and the second electrode is any of the multiple electrodes other than the first electrode.

[0040] The processing unit 1012 is used to output the electrocardiogram of the target object based on the electrocardiogram signal, determine the polarization voltage change value between the electrodes based on the polarization voltage, determine the impedance phase angle of the second electrode based on the AC signal and the response voltage, perform electrode connection detection based at least on the polarization voltage change value and the impedance phase angle, obtain the electrode connection result, and control the LED indicator 1011 to flash according to the color corresponding to the target electrode when the electrode connection result indicates that the target electrode has fallen off.

[0041] Therefore, during ECG monitoring, connection checks can be performed on each electrode, automatically identifying the cause of lead detachment and reducing manual judgment, thus improving ECG monitoring efficiency. Furthermore, polarization voltage changes can accurately locate abnormal electrodes, and impedance phase angle reflects the electrical contact between the electrode and the skin surface. Changes in phase angle are more sensitive than changes in impedance amplitude, providing early warning before signal quality truly deteriorates. This effectively distinguishes between true detachment (drastic phase angle changes) and transient impedance amplitude fluctuations caused by exercise or respiration. Therefore, combining polarization voltage changes and impedance phase angle for electrode connection detection not only accurately pinpoints the cause of lead detachment to a single electrode but also improves detection efficiency and accuracy, reducing false alarms.

[0042] In some embodiments, the data acquisition unit 103 may include a disposable wearable ECG sensor with a built-in power supply for acquiring ECG signals through multiple electrodes within a first time window. That is, the ECG sensor in this embodiment is a disposable consumable and has its own battery; the monitoring time under full charge can be greater than or equal to 24 hours.

[0043] For example, the ECG lead 102 can be a three-lead ECG cable or a five-lead ECG cable. Taking a five-lead ECG cable as an example, the data acquisition unit can acquire ECG signals through the five electrodes in contact with the target subject's skin within the first time window. Figure 2As shown, the five electrodes may include: a white (right arm or RA) electrode, placed below the clavicle, near the right shoulder; a black (left arm or LA) electrode, placed below the clavicle, near the left shoulder; a green (right leg or RL) electrode, placed on the right abdomen; a red (left leg or LL) electrode, placed on the left abdomen; and a brown (chest or V) electrode, placed on the chest wall. Therefore, based on the acquired electrocardiogram signal, an output can be generated. Figure 3 The electrocardiogram shown is shown.

[0044] For example, the ECG monitoring sensor system 100 can use 1ms as the basic time unit, allocating a dedicated 1ms window every 100ms for signal injection and response acquisition. For instance, the first time window could correspond to 0-99ms, meaning 99 ECG points could be continuously acquired. Then, a 5nA / 0.5Hz sinusoidal current is injected at 99.0ms, the impedance response voltage is acquired at 99.5ms, and data processing is performed from 99.5ms to 100ms to calculate the impedance phase angle. If an ECG sampling point is lost, it can be filled by interpolation using data from the preceding and following 1ms. Thus, ECG acquisition and impedance monitoring can be synchronized, and the time-division multiplexing mechanism ensures that ECG signal acquisition and impedance phase angle calculation do not interfere with each other.

[0045] For example, the polarization voltage is measured during the ECG sampling interval (e.g., 100 μs) to avoid signal interference. For instance, the polarization voltage (±300 mV) is nearly 100 times larger than the ECG signal (1-5 mV). The data acquisition unit can be configured with dual channels: one channel acquires the ECG signal through a high-gain PGA, and the other channel acquires the polarization voltage through a low-gain PGA. Thus, the polarization voltage acquisition occurs during the ECG signal sampling interval, completed at millisecond speeds, without affecting normal ECG monitoring. This allows for both high-fidelity amplification of the ECG signal and accurate monitoring of electrode contact status. Furthermore, it should be understood that since the polarization voltage acquisition occurs during the ECG signal sampling interval, the injected signal is precisely at a trough or zero-phase point. Therefore, the sinusoidal current signal injected at the impedance phase angle will not affect the polarization voltage acquisition.

[0046] For example, the processing unit 1012 may include a lock-in amplifier, through which the impedance phase angle can be obtained. It should also be understood that the first electrode is the signal injection terminal, and its impedance phase angle can be indirectly obtained through frequency domain analysis of the error voltage of the RLD feedback loop. Furthermore, impedance monitoring of other electrodes can already cover most detachment scenarios, and the monitoring requirement for the RL electrode is relatively low. Therefore, by monitoring the loop integrity of the injected current, the state of the RL electrode can be indirectly determined.

[0047] For example, the polarization voltage change value can include the absolute difference in polarization voltage between the RA and LL electrodes and the absolute difference in polarization voltage between the LA and RL electrodes. The absolute difference in polarization voltage between the RA and LL electrodes characterizes an upper limb monitoring indicator, while the absolute difference in polarization voltage between the LA and RL electrodes characterizes a lower limb monitoring indicator. If the upper limb monitoring indicator shows an abnormal increase, it indicates that the fault is concentrated at the RA or LL electrode. Furthermore, if the polarization voltage of the RA electrode is abnormal (e.g., changing from -80mV to +200mV), while the polarization voltage of the LL electrode remains stable, the source of the abnormality can be identified as the RA electrode. Similarly, if the lower limb monitoring indicator shows an abnormal increase, it indicates that the fault is concentrated at the LA or RL electrode. Furthermore, if the polarization voltage of the LA electrode is abnormal, while the polarization voltage of the RL electrode remains stable, the source of the abnormality can be identified as the LA electrode.

[0048] It should be understood that when the electrode gel is moist and sufficiently moist, and in close contact with the skin, it forms an ion-conducting channel. Under ideal electrochemical contact conditions, due to the presence of a very small resistance component, the electrode's impedance phase angle is close to the theoretical value of 90° but slightly lower. If the electrode detaches, the contact area decreases, causing the electrode's impedance phase angle to tend to shift towards 0° (pure resistance), resulting in a smaller impedance phase angle. The angle of decrease is proportional to the degree of electrode loosening. For example, if the electrode's impedance phase angle is stable at around 85°, it indicates that the electrode is in normal contact with the target object's skin. If the electrode's impedance phase angle is less than 60°, it indicates that the electrode has detached.

[0049] It should also be understood that if a short circuit or device failure occurs, the impedance phase angle of the electrode will exceed 90°, for example, greater than 110°. In this case, an alarm can also be triggered.

[0050] Therefore, combining polarization voltage change and impedance phase angle for electrode connection detection not only accurately pinpoints the cause of lead detachment to a single electrode, but also improves detection efficiency and accuracy, reducing false alarms. For example, the lower limb monitoring index for the LA electrode is 230mV, which is greater than the preset voltage threshold of 150mV, and the impedance phase angle is 52°, which is less than the preset angle threshold of 60°. In this case, the electrode connection result can be determined to indicate LA electrode detachment, and then the LED indicator light can be controlled to flash according to the color corresponding to the LA electrode (e.g., yellow) to indicate this.

[0051] It should be understood that the ECG monitoring sensing system in this embodiment may have Bluetooth functionality. For example, a flashing blue LED indicator 1011 may indicate a Bluetooth broadcast connection; a flashing green LED may indicate a successful Bluetooth connection and normal machine operation; and a flashing red LED may indicate low battery. Therefore, the color indicators corresponding to different electrodes may be distinguishable from blue, green, and red. For example, as mentioned above, the LA electrode may correspond to yellow. The specific color can be set according to actual needs, and this embodiment does not limit this.

[0052] In some embodiments, a Hall sensor is provided in the push-pull self-locking interface 1013. The Hall sensor is used to detect the Hall voltage after the push-pull self-locking interface 1013 is connected to the ECG lead 102. The processing unit 1012 is used to determine the magnetic interface displacement of the ECG lead 102 and the push-pull self-locking interface 1013 based on the Hall voltage, and to determine the engagement status of the ECG lead 102 and the push-pull self-locking interface 1013 based on the numerical relationship between the magnetic interface displacement and the preset displacement threshold. The electrode connection is detected based on the engagement status, the polarization voltage change value and the impedance phase angle.

[0053] In other words, the embodiments of this disclosure can combine magnetic displacement detection, polarization voltage change value and impedance phase angle to make a comprehensive judgment on electrode connection, which not only makes a judgment from an electrical point of view, but also from a physical connection point of view, thereby further improving the detection accuracy.

[0054] For example, the preset displacement threshold can be set to 0.5mm. If the magnetic interface displacement is less than 0.5mm, it indicates normal engagement; if it is greater than or equal to 0.5mm, it indicates that the connection has come loose.

[0055] In some embodiments, the data acquisition unit 103 further includes an accelerometer for detecting the motion state of the target object; the processing unit 1012 is used to increase the preset displacement threshold when the motion state indicates that the target object is in motion, and to restore the preset displacement threshold to the default initial value when the motion state indicates that the target object has stopped moving.

[0056] For example, when the target object is in motion, the initial default displacement threshold of 0.5mm is increased to 0.6mm. When the target object stops moving, the default displacement threshold is restored to 0.5mm. This allows for motion tolerance, avoids false alarms caused by transient motion interference, and further improves detection accuracy.

[0057] In some embodiments, the displacement data from the accelerometer and the magnetic interface can be spatiotemporally fused, and then the motion state can be determined based on the spatiotemporally fused data. Temporal fusion ensures that each data point has a completely consistent timestamp, which can be achieved through data acquisition using a unified clock source. Spatial fusion determines whether the direction of displacement change is consistent with the direction of motion, thereby clarifying whether the electrode detachment is caused by the overall motion of the target object.

[0058] For example, firstly, based on the Hall sensor data and differential calculation of the magnetic interface, the displacement vector direction of the magnetic interface can be calculated, and based on the accelerometer data, the motion vector direction of the target object can be calculated. Then, the matching degree between the displacement vector direction and the motion vector direction can be compared. If the displacement vector direction and the motion vector direction are the same, it can be determined that the target object is in motion. Therefore, to reduce false alarms, the initial default preset displacement threshold of 0.5mm can be increased to 0.6mm to suppress alarms. If the displacement vector direction and the motion vector direction are completely different, it can be determined that the target object has stopped moving. Therefore, the preset displacement threshold can be restored to 0.5mm to improve detection accuracy.

[0059] In some embodiments, the processing unit 1012 is configured to determine a first connection value based on the fastening condition, a second connection value based on the polarization voltage and the polarization voltage change value, a third connection value based on the impedance phase angle, and to perform a weighted summation of the first connection value, the second connection value, and the third connection value based on a preset weight to obtain a fusion weight value. Based on the numerical relationship between the fusion weight value and the preset weight threshold, an electrode connection result is obtained. The first connection value, the second connection value, and the third connection value are 0 or 1. A first connection value, the second connection value, and the third connection value of 0 indicates a normal connection, and a first connection value, the second connection value, and the third connection value of 1 indicates an abnormal connection.

[0060] For example, if the engagement condition indicates normal engagement, then the first connection value can be determined to be 0; if the engagement condition indicates that the connection has fallen off, then the first connection value can be determined to be 1.

[0061] In some embodiments, the plurality of electrodes further include an RA electrode for placement on the right shoulder side below the clavicle of the target object, an LA electrode for placement on the left shoulder side below the clavicle of the target object, and an LL electrode for placement on the left abdomen of the target object; the processing unit 1012 is used to take the absolute difference of polarization voltage between the RA electrode and the LL electrode as the upper limb voltage change value, and the absolute difference of polarization voltage between the LA electrode and the RL electrode as the lower limb voltage change value, and to perform electrode connection detection based on the upper limb voltage change value, the lower limb voltage change value, and the change of polarization voltage of a single electrode among the plurality of electrodes within a preset time period, to obtain a second connection value.

[0062] For example, if the voltage change value of the upper limb is normal, the voltage change value of the lower limb is abnormal, and the LA electrode changes abruptly, then the LA electrode can be determined to be faulty, and thus the second connection value can be obtained as 1.

[0063] In some embodiments, the processing unit 1012 is configured to determine the third connection value as 1 when the impedance phase angle is less than a first preset angle threshold or the impedance phase angle is greater than a second preset angle threshold, and to determine the third connection value as 0 when the difference between the impedance phase angle and the third preset angle threshold is less than a preset angle difference; wherein the first preset angle threshold is less than the second preset angle threshold, and the third preset angle threshold is greater than the first preset angle threshold and less than the second preset angle threshold.

[0064] For example, the first preset angle threshold, the second preset angle threshold, the third preset angle threshold, and the preset angle difference can be set according to actual needs. For instance, the first preset angle threshold can be set to 60°, the second preset angle threshold to 110°, the third preset angle threshold to 90°, and the preset angle difference to 5°.

[0065] For example, the preset weights include the weights corresponding to magnetic displacement detection, impedance phase angle detection, and polarization voltage detection, respectively. For instance, the weights for magnetic displacement detection, impedance phase angle detection, and polarization voltage detection are 0.5, 0.3, and 0.2, respectively. The preset weight threshold can be set according to requirements, for example, it can be set to 0.8.

[0066] For example, in a scenario where the LA electrode detaches, the magnetic displacement detection is first triggered. The detected displacement of the magnetic interface is 0.55mm, which is greater than the preset displacement threshold of 0.5mm. This indicates an abnormal connection, thus determining the first connection value as 1. Next, impedance phase angle detection is performed. The detected impedance phase angle of the LA electrode is 52°, which is less than the preset angle threshold of 60°, indicating partial electrode detachment. This determines the second connection value as 1. Then, the polarization voltage change is calculated, yielding a lower limb monitoring index of 230mV, which is greater than the preset voltage threshold of 150mV. This indicates an LA electrode malfunction, thus determining the third connection value as 1. Finally, a weighted sum is performed based on preset weights, resulting in: Fusion Weight Value = (1×0.5) + (1×0.3) + (1×0.2) = 1.0, which is greater than the preset weight threshold of 0.8. Therefore, it can be determined that the LA electrode has detached, triggering the "ECGLA Lead Detachment" alarm.

[0067] In some embodiments, the processing unit 1012 is further configured to control the analog-to-digital converter in the data acquisition unit to switch from a first acquisition mode to a second acquisition mode when the electrode connection result indicates that the target electrode has detached, and to control the analog-to-digital converter in the data acquisition unit to return from the second acquisition mode to the first acquisition mode after the target electrode is reconnected, wherein the sampling rate of the second acquisition mode is higher than that of the first acquisition mode.

[0068] For example, the sampling rate of the first acquisition mode is 500Hz / 12bit, and the sampling rate of the second acquisition mode is 1kHz / 24bit. This allows the alarm triggering mechanism to be linked with the hardware sampling capability, enabling on-demand allocation of computing and storage resources to provide the highest fidelity data at critical moments, rather than indiscriminately acquiring high-frequency data throughout.

[0069] In some embodiments, the processing unit 1012 is further configured to perform downgrade control on the working mode of the electrocardiogram recorder according to the detachment status of the target electrode when the electrode connection result indicates that the target electrode has detached. The working modes of the electrocardiogram recorder include ST mode, monitoring mode and deep filtering mode. The working level of ST mode is higher than that of monitoring mode, and the working level of monitoring mode is higher than that of deep filtering mode.

[0070] For example, the ST mode has a bandwidth of 0.05-100Hz and can be used for myocardial ischemia monitoring, with common-mode suppression greater than 90dB, requiring manual power frequency notch filtering. The monitoring mode has a bandwidth of 0.5-40Hz and achieves greater than 100dB anti-interference through automatic notch filtering, suitable for routine monitoring. The deep filtering mode has a bandwidth of 1-20Hz, providing extreme suppression of electromyographic interference, and can be used in high-interference scenarios such as intraoperative procedures or patient transport. In this embodiment, when a lead dislodgement alarm is detected, a working mode degradation strategy may be triggered.

[0071] In some embodiments, the processing unit 1012 is configured to control the working mode of the electrocardiogram recorder 101 to switch to monitoring mode when there is only one target electrode and the working mode of the electrocardiogram recorder 101 is ST mode, and to control the working mode of the electrocardiogram recorder to switch to deep filtering mode when there are two or more target electrodes and the working mode of the electrocardiogram recorder 101 is monitoring mode.

[0072] Therefore, if the current mode is ST mode and any electrode detachment alarm occurs, a forced downgrade to monitoring mode is implemented to ensure uninterrupted baseline heart rate monitoring and avoid ST misjudgment due to incomplete lead connections. If the current mode is monitoring mode and multiple electrode detachment alarms occur, a forced downgrade to deep filtering mode is implemented to filter signal noise through narrow bandwidth, maintaining the accuracy of core parameters (such as heart rate) even when signal quality is low. It should be understood that if the current mode is deep filtering mode, no downgrade control is required.

[0073] For example, the ECG monitoring sensor system 100 may also include a power button, a USB port, and a Bluetooth port. The power button provides the function of turning the device on or off by pressing and holding it for 3 seconds. The USB port and Bluetooth port provide data transfer capabilities.

[0074] For example, the USB interface standard uses USB Type-C, and the USB transmission standard uses USB 2.0. The Bluetooth standard is 5.4, the communication frequency band is 2.402GHz to 2.480GHz, and the communication distance is 10 meters. A USB-to-serial driver must be pre-installed upon first use. Specifically, as shown... Figure 4 As shown, first locate the "CH341SER.exe" driver executable file in the folder "\ECG_Application\CH340_CH341 Driver", right-click to open it, and select "Install". Next, locate the USB-to-serial module and insert it into the computer's USB port. Then, locate the five-lead ECG cable, insert the connector into the machine, and press and hold for 3 seconds to power on. The blue LED will flash, indicating that Bluetooth connection is required. The ECG electrode installation locations are as follows. Figure 2 As shown. Then, locate the "ECG_BLE_APP.exe" file (the five-lead ECG application) in the "ECG_Application" folder, right-click to open it, and follow the instructions. Figure 5-7 Steps 1, 2, 3, 4, and 5 are shown to establish a Bluetooth connection. After the Bluetooth connection is complete, as shown... Figure 8 As shown, it will automatically return to the main ECG waveform interface.

[0075] The preferred embodiments of this disclosure have been described in detail above with reference to the accompanying drawings. However, this disclosure is not limited to the specific details of the above embodiments. Within the scope of the technical concept of this disclosure, various simple modifications can be made to the technical solutions of this disclosure, and these simple modifications all fall within the protection scope of this disclosure.

[0076] It should also be noted that the various specific technical features described in the above specific embodiments can be combined in any suitable manner without contradiction. In order to avoid unnecessary repetition, this disclosure will not describe the various possible combinations separately.

[0077] Furthermore, various different embodiments of this disclosure can be combined in any way, as long as they do not violate the spirit of this disclosure, they should also be regarded as the content disclosed in this disclosure.

Claims

1. An electrocardiogram (ECG) monitoring sensing system, characterized in that, The device includes an electrocardiogram (ECG) recorder, ECG leads, and a data acquisition unit. The ECG recorder includes LED indicators, a processing unit, and a push-pull self-locking interface for connecting the ECG leads. The data acquisition unit is connected to the ECG recorder through the ECG leads and the push-pull self-locking interface. A Hall sensor is installed inside the push-pull self-locking interface. The data acquisition unit is used to acquire electrocardiogram (ECG) signals through multiple electrodes in contact with the skin of the target object within a first time window, acquire the response voltage of the second electrode after an excitation signal is injected into the first electrode within a second time window, and acquire the polarization voltage of the multiple electrodes respectively during the sampling interval of the ECG signals. The first electrode is an RL electrode placed on the right abdomen of the target object, and the second electrode is other electrodes among the multiple electrodes besides the first electrode. The Hall sensor is used to detect the Hall voltage after the push-pull self-locking interface is connected to the ECG lead wire; The processing unit is configured to: output an electrocardiogram of the target object based on the electrocardiogram signal; determine the polarization voltage change value between electrodes based on the polarization voltage; determine the impedance phase angle of the second electrode based on the excitation signal and the response voltage; determine the magnetic interface displacement of the electrocardiogram lead and the push-pull self-locking interface based on the Hall voltage; determine the engagement status of the electrocardiogram lead and the push-pull self-locking interface based on the numerical relationship between the magnetic interface displacement and a preset displacement threshold; determine a first connection value based on the engagement status; determine a second connection value based on the polarization voltage and the polarization voltage change value; and determine a third connection value based on the impedance phase angle. The connection value is obtained by weighting and summing the first connection value, the second connection value, and the third connection value based on preset weights to obtain a fusion weight value. Based on the numerical relationship between the fusion weight value and the preset weight threshold, the electrode connection result is obtained. If the electrode connection result indicates that the target electrode has detached, the LED indicator is controlled to flash according to the color corresponding to the target electrode. The first connection value, the second connection value, and the third connection value are 0 or 1. The first connection value, the second connection value, and the third connection value are 0, indicating that the connection is normal. The first connection value, the second connection value, and the third connection value are 1, indicating that the connection is abnormal.

2. The electrocardiogram monitoring sensing system according to claim 1, characterized in that, The plurality of electrodes also includes an RA electrode for placement on the right shoulder side below the clavicle of the target object, an LA electrode for placement on the left shoulder side below the clavicle of the target object, and an LL electrode for placement on the left abdomen of the target object; The processing unit is used to take the absolute difference of polarization voltage between the RA electrode and the LL electrode as the upper limb voltage change value, and the absolute difference of polarization voltage between the LA electrode and the RL electrode as the lower limb voltage change value. Based on the changes in the upper limb voltage change value, the lower limb voltage change value, and the polarization voltage of a single electrode among the multiple electrodes within a preset time period, the electrode connection is detected to obtain a second connection value.

3. The electrocardiogram monitoring sensing system according to claim 1, characterized in that, The processing unit is used to determine the third connection value as 1 when the impedance phase angle is less than the first preset angle threshold or the impedance phase angle is greater than the second preset angle threshold, and to determine the third connection value as 0 when the difference between the impedance phase angle and the third preset angle threshold is less than the preset angle difference. Wherein, the first preset angle threshold is less than the second preset angle threshold, and the third preset angle threshold is greater than the first preset angle threshold and less than the second preset angle threshold.

4. The electrocardiogram monitoring sensing system according to any one of claims 1-3, characterized in that, The data acquisition unit also includes an accelerometer for detecting the motion state of the target object; The processing unit is used to increase the preset displacement threshold when the motion state indicates that the target object is in motion, and to restore the preset displacement threshold to the default initial value when the motion state indicates that the target object has stopped moving.

5. The electrocardiogram monitoring sensing system according to any one of claims 1-3, characterized in that, The data acquisition unit includes a disposable wearable electrocardiogram sensor; The wearable ECG sensor has a built-in power supply and is used to collect ECG signals through the multiple electrodes within the first time window.

6. The electrocardiogram monitoring sensing system according to any one of claims 1-3, characterized in that, The processing unit is further configured to, when the electrode connection result indicates that the target electrode has detached, control the analog-to-digital converter in the data acquisition unit to switch from a first acquisition mode to a second acquisition mode, and after the target electrode is reconnected, control the analog-to-digital converter in the data acquisition unit to return from the second acquisition mode to the first acquisition mode, wherein the sampling rate of the second acquisition mode is higher than that of the first acquisition mode.

7. The electrocardiogram monitoring sensing system according to any one of claims 1-3, characterized in that, The processing unit is further configured to, when the electrode connection result indicates that the target electrode has detached, degrade the operating mode of the electrocardiogram recorder according to the detachment status of the target electrode. The operating modes of the electrocardiogram recorder include ST mode, monitoring mode, and deep filtering mode. The operating level of ST mode is higher than that of monitoring mode, and the operating level of monitoring mode is higher than that of deep filtering mode.

8. The electrocardiogram monitoring sensing system according to claim 7, characterized in that, The processing unit is used to control the working mode of the electrocardiogram recorder to switch to the monitoring mode when there is only one target electrode and the working mode of the electrocardiogram recorder is ST mode, and to control the working mode of the electrocardiogram recorder to switch to the deep filtering mode when there are two or more target electrodes and the working mode of the electrocardiogram recorder is monitoring mode.

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