A multi-lead real-time electrocardiogram monitoring device and monitoring method

Abstract

This invention relates to a multi-lead real-time electrocardiogram (ECG) monitoring device and a real-time ECG monitoring method using the device. Compared with existing ECG monitoring equipment, the multi-lead real-time ECG monitoring device provided by this invention is lighter and more portable, provides monitoring and early warning functions, and can switch to multi-lead monitoring mode at any time according to the early warning or the user's own wishes to obtain more ECG information. No professional medical guidance or interpretation is required. Users can view or understand their ECG status in real time, which is conducive to the timely detection of myocardial ischemia (coronary heart disease) and other heart diseases, providing sufficient time for treatment or rescue.

Description

Technical Field

[0001] This invention relates to the field of medical monitoring, and more particularly to a wearable multi-lead real-time electrocardiogram monitoring device and monitoring method. Background Technology

[0002] An electrocardiogram (ECG) is a non-invasive examination used to record the electrical activity of the heart. It involves placing electrodes on the patient's skin to measure the electrical signals obtained from the body surface and converting them into a visual graph that reflects the heart's function and rhythm. An ECG records the electrical signals generated by the heart during each contraction and relaxation. These signals represent the process by which the impulse generated at the heart's pacemaker (sinoatrial node) propagates through the heart tissue. Through an ECG, doctors can assess the heart's rhythm, cardiac hypertrophy, myocardial ischemia, myocardial damage, and the presence of other heart conditions.

[0003] The number of cardiovascular disease patients is increasing rapidly year by year. The traditional hospital-centered monitoring service model can hardly meet the growing demand for ECG monitoring. Instead, a distributed ECG monitoring model centered on individuals and families is needed. This requires a dynamic ECG monitoring method that can be used for a long time in daily life, is stable, comfortable, and easy to operate.

[0004] With the development of mobile healthcare technology, the connection between wearable ECG devices and healthcare platforms has provided many conveniences for personal health monitoring. However, existing consumer-grade ECG devices cannot be used to make decisive treatment decisions, such as discontinuing anticoagulants. Furthermore, the alert modes of current wearable devices (such as watches and wristbands) are mainly based on single-lead ECG monitoring, which has limited value for myocardial ischemia (coronary artery disease). Summary of the Invention

[0005] This invention discloses a single-lead combined with multi-lead real-time electrocardiogram monitoring device and monitoring method, aiming to solve the technical problems existing in the prior art.

[0006] The present invention adopts the following technical solution:

[0007] In a first aspect, embodiments of the present invention provide a single-lead combined with multi-lead real-time electrocardiogram monitoring device, including a main body and a wristband connected thereto;

[0008] The bottom of the main body can contact the upper limb surface of the human body when worn. The bottom of the main body is provided with a single-lead ECG monitoring element and a first multi-lead ECG monitoring element. The single-lead ECG monitoring element can collect ECG data of the human upper limb when worn, and the first multi-lead ECG monitoring element can collect ECG data of the human left lower limb when not worn. The single-lead ECG monitoring element and the first multi-lead ECG monitoring element work in an alternating manner.

[0009] The main body has a computing module and a power supply module, both of which are connected to the single-lead ECG monitoring element and the first multi-lead ECG monitoring element, respectively.

[0010] When not worn, the wristband is a strip-shaped structure. When worn, the two ends of the wristband can be connected end to end to form a loop. Each end of the wristband is equipped with a second multi-lead ECG monitoring element. Both second multi-lead ECG monitoring elements are connected to the computing module and power supply module through wires embedded in the wristband. The two second multi-lead ECG monitoring elements can collect ECG data of the two upper limbs of the human body when not worn.

[0011] As a preferred technical solution, the single-lead ECG monitoring element is configured as a photoelectric sensor. The photoelectric sensor can measure the reflection or absorption data of light in the blood of the upper limb when worn, and the calculation module can calculate the user's single-lead real-time ECG data based on the photoelectric data.

[0012] As a preferred technical solution, the single-lead ECG monitoring element is configured as a pair of resistive sensors. The resistive sensors can acquire the resistance of the upper limbs when worn, and the calculation module can calculate the user's single-lead real-time ECG data based on the change in resistance.

[0013] As a preferred technical solution, both the first multi-lead ECG monitoring element and the second multi-lead ECG monitoring element are configured as metal electrodes;

[0014] Multiple metal electrodes can be placed in contact with the left lower limb, left upper limb, and right upper limb respectively when not worn, and collect real-time electrocardiogram data of six leads of the limbs.

[0015] As a preferred technical solution, each metal electrode has mechanically engraved or laser-etched markings on its surface. These markings include the electrode's orientation, guiding the user to place different metal electrodes at different positions on the limb to obtain real-time electrocardiogram data from six leads of the limb.

[0016] As a preferred technical solution, the main body also includes a storage module, which is connected to the computing module. The storage module can record the user's single-lead ECG data and multi-lead ECG data respectively.

[0017] As a preferred technical solution, it also includes a chest strap, on one side of which are provided six third multi-lead ECG monitoring elements, which can acquire real-time ECG data of six leads in front of the chest.

[0018] The six third multi-lead ECG monitoring elements are respectively located at the right edge of the fourth intercostal space beside the sternum, the left edge of the fourth intercostal space beside the sternum, the left edge of the fifth intercostal space, above the midclavicular line of the fifth intercostal space, at the horizontal position of the midclavicular line of the fifth intercostal space, and below the midclavicular line of the fifth intercostal space.

[0019] As a preferred technical solution, the chest strap is strip-shaped and can be worn or attached to the user's chest when in use, and wrapped and fixed to the outer periphery of the wrist strap when not in use.

[0020] The chest strap contains an embedded wire that connects to the third multi-lead ECG monitoring element. The lead-out terminals of the wire can be connected to the main body to transmit the ECG data acquired by the third multi-lead ECG monitoring element to the computing module.

[0021] As a preferred technical solution, several third multi-lead ECG monitoring elements are configured as metal electrodes, each third multi-lead ECG monitoring element is connected to the main body through a separate wire, and an insulating gap is set between adjacent third multi-lead ECG monitoring elements.

[0022] As a preferred technical solution, the main body also includes a wireless communication module, which is connected to the computing module and is used to transmit the acquired real-time electrocardiogram data to the mobile terminal.

[0023] As a preferred technical solution, the main body is also equipped with a touch screen display, which is connected to the computing module and used to switch the working status of the single-lead ECG monitoring element and the first multi-lead ECG monitoring element.

[0024] Secondly, embodiments of the present invention also provide a real-time electrocardiogram (ECG) monitoring method using a multi-lead real-time ECG monitoring device as described in any of the preceding claims, the method comprising the following steps:

[0025] Photoelectric signals from the upper limbs are acquired using a single-lead ECG monitoring element;

[0026] The presence of abnormalities in a single-lead real-time electrocardiogram is determined based on the photoelectric signal.

[0027] When an abnormality is detected, an early warning message is issued, the wristband is released, and the first potential signal of the left lower limb and both upper limbs is simultaneously acquired based on the first multi-lead ECG monitoring element and the second multi-lead ECG monitoring element, respectively.

[0028] Calculate the real-time electrocardiogram data of the limbs using the first potential signal.

[0029] As a preferred technical solution, the step of determining whether there is an abnormality in a single-lead real-time electrocardiogram based on the photoelectric signal further includes: dynamically adjusting the warning level and intensity according to changes in the external environment.

[0030] As a preferred technical solution, the step of releasing the wristband further includes:

[0031] The first multi-lead ECG monitoring element is attached to any part of the left lower limb;

[0032] Hold the second multi-lead ECG monitoring element at each end of the wristband with both hands.

[0033] As a preferred technical solution, the first potential signal includes the electrocardiogram signals corresponding to leads I, II, III, aVR, aVL, and aVF, respectively.

[0034] As a preferred technical solution, after the step of calculating the real-time electrocardiogram data of the six leads of the limbs based on the first potential signal, the method further includes:

[0035] Release the chest strap and wear or attach it to your chest;

[0036] The second potential signal is obtained based on the third multi-lead ECG monitoring element;

[0037] Real-time ECG data for the chest leads are calculated based on the second potential signal.

[0038] As a preferred technical solution, the second potential signal includes the electrocardiogram signals corresponding to leads V1, V2, V3, V4, V5, and V6, respectively.

[0039] One embodiment of the above invention has the following advantages or beneficial effects:

[0040] This invention primarily provides a multi-lead real-time electrocardiogram (ECG) monitoring device and a real-time ECG monitoring method using the device. The aforementioned multi-lead real-time ECG monitoring device is wearable on the wrist and includes both single-lead and multi-lead ECG monitoring elements. In its initial state, the single-lead ECG monitoring element can acquire basic ECG information in real time while worn, enabling convenient, preliminary health monitoring and ECG assessment around the clock, and quickly screening for abnormalities. When abnormalities occur in the data acquired under single-lead monitoring, an alert is issued, reminding the user to release the wristband and initiate multi-lead real-time ECG monitoring. At this time, the user presses the second multi-lead ECG monitoring element at both ends of the wristband with both hands, placing the first multi-lead ECG monitoring element at the bottom of the device body against the skin of the lower limb, thus achieving real-time ECG monitoring of six leads in the limb. This provides more comprehensive information than a single-lead ECG, with higher accuracy and sensitivity, and can better locate the location and type of cardiac abnormalities, allowing the user to immediately understand their cardiac health status and promptly send this information to a doctor for a more accurate diagnosis.

[0041] In some preferred embodiments, the multi-lead real-time ECG monitoring device can adjust the warning level up or down according to environmental factors, and can also predict the probability of heart disease occurrence based on environmental conditions, which helps users to more accurately predict and prevent diseases.

[0042] Furthermore, the multi-lead real-time ECG monitoring device also features a chest strap. When not in use, the chest strap can be wrapped and secured to one side of the wristband for easy carrying. One side of the chest strap has six third multi-lead ECG monitoring elements, which can acquire real-time ECG data from six leads in the chest. When an abnormality is detected in a single lead, the chest strap is released and adhered to the user's chest. Simultaneously, the second multi-lead ECG monitoring elements at both ends of the wristband are squeezed with both hands, and the first multi-lead ECG monitoring element is placed against the skin of the lower limb. This allows for the simultaneous acquisition of real-time ECG data from six leads in the limbs and six leads in the chest, providing more detailed ECG waveforms and offering perspectives of heart activity in different directions. This enables more accurate detection of cardiac abnormalities and diagnosis of heart diseases.

[0043] Compared to existing ECG monitoring devices, the multi-lead real-time ECG monitoring device provided in this embodiment is more lightweight and portable, provides monitoring and early warning functions, and can switch to multi-lead monitoring mode at any time according to the early warning or the user's own wishes. It does not require the guidance or interpretation of a professional doctor. Users can view or understand their ECG status in real time, which is conducive to the timely detection of myocardial ischemia (coronary heart disease) and other heart diseases, providing ample time for treatment or rescue. Attached Figure Description

[0044] To more clearly illustrate the technical solutions of the embodiments of the present invention, the accompanying drawings used in the description of the embodiments will be briefly introduced below, forming part of the present invention. The illustrative embodiments of the present invention and their descriptions explain the present invention and do not constitute an improper limitation of the present invention. In the accompanying drawings:

[0045] Figure 1 This is a schematic diagram of the structure of the multi-lead real-time electrocardiogram monitoring device in the non-wearing state according to a preferred embodiment of Embodiment 1 of the present invention;

[0046] Figure 2 This is a schematic diagram of the structure of the multi-lead real-time electrocardiogram monitoring device in the non-wearing state according to a preferred embodiment of Embodiment 1 of the present invention;

[0047] Figure 3 This is a schematic diagram of the structure of a multi-lead real-time electrocardiogram monitoring device in a preferred embodiment of Embodiment 1 of the present invention;

[0048] Figure 4 This is a structural block diagram of the internal structure of the main body in a preferred embodiment of Embodiment 1 of the present invention;

[0049] Figure 5 This is a structural block diagram of the internal structure of the main body in a preferred embodiment of Embodiment 2 of the present invention.

[0050] Specifically, the following reference numerals are included:

[0051] The system comprises: a main body 100, a single-lead ECG monitoring element 110, a touch screen display 120, a computing module 130, a power supply module 140, a wireless communication module 150, a storage module 160, an environmental sensor 170, a first multi-lead ECG monitoring element 180, a wristband 200, a second multi-lead ECG monitoring element 210, a chest strap 300, and a third multi-lead ECG monitoring element 310. Detailed Implementation

[0052] To make the objectives, technical solutions, and advantages of this invention clearer, the technical solutions of this invention will be clearly and completely described below in conjunction with specific embodiments and corresponding drawings. In the description of this invention, it should be noted that the term "or" is generally used to include the meaning of "and / or," unless otherwise expressly indicated.

[0053] Obviously, the described embodiments are only some, not all, of the embodiments of the present invention. All other embodiments obtained by those skilled in the art based on the embodiments of the present invention without inventive effort are within the scope of protection of the present invention.

[0054] In existing technologies, many smartwatches have ECG monitoring components. However, since smartwatches use a single-lead ECG monitoring solution, there are many drawbacks. For example, a single-lead ECG uses only one electrode to record the ECG signal, which provides less information compared to a multi-lead ECG. Therefore, it may not provide enough detail to assess complex heart problems or capture certain ECG abnormalities, such as acute myocardial infarction. In addition, a single-lead ECG is difficult to provide a panoramic view of the entire heart, so the diagnostic accuracy may be limited in certain diseases or abnormalities.

[0055] To accurately monitor the heart from multiple angles in real-time electrocardiograms, a simultaneous multi-lead approach is required. However, current multi-lead real-time electrocardiogram monitoring devices are large in size and have a large number of electrodes, which not only increases the difficulty of operation and the time cost, but also makes them inconvenient to carry around, limiting their application in clinical and daily monitoring. Furthermore, multi-lead electrocardiograms typically record a large amount of data, containing more signals and waveforms, and their interpretation and analysis require doctors to have higher professional knowledge and technical skills, which also limits their independent application in certain daily scenarios.

[0056] Example 1

[0057] To address the numerous issues present in single-lead and multi-lead solutions, this invention provides a wearable multi-lead real-time ECG monitoring device, aiming to provide users with more accurate ECG data, while simplifying the usage process, reducing device size, and providing a better user experience.

[0058] like Figure 1-4 In a preferred embodiment, the multi-lead real-time electrocardiogram monitoring device is configured as a wearable structure, specifically a watch-like structure, including a main body 100 and a wristband 200 connected thereto. The bottom of the main body 100 can contact the upper limb surface of the human body when worn. The wristband 200 is a strip-shaped structure when not worn. The two ends of the wristband 200 can be connected end to end to form a loop when worn to assist the user in wearing it on the wrist.

[0059] In a preferred embodiment, a touch screen display 120 is provided on the upper surface of the body 100, and a single-lead ECG monitoring element 110 and a first multi-lead ECG monitoring element 180 are spaced apart on the lower surface of the body 100. The single-lead ECG monitoring element 110 can collect ECG data of the upper limb when worn, and the first multi-lead ECG monitoring element 180 can collect ECG data of the left lower limb when not worn. Figure 2The single-lead ECG monitoring element 110 and the first multi-lead ECG monitoring element 180 operate alternately. The main body 100 internally houses a computing module 130 and a power supply module 140, both connected to the single-lead ECG monitoring element 110 and the first multi-lead ECG monitoring element 180, respectively. A touchscreen display 120 is connected to the computing module 130. Preferably, the main body 100 further includes a wireless communication module 150 and a storage module 160, both connected to the computing module 130. The wireless communication module 150 transmits the acquired real-time ECG data to a mobile terminal, while the storage module 160 records the user's single-lead and multi-lead ECG data respectively, comparing the acquired ECG data to determine if any abnormalities exist and issuing an early warning.

[0060] In a preferred embodiment, the touch display screen 120 can switch the working state of the single-lead ECG monitoring element 110 and the multi-lead ECG monitoring element according to the user's operation. The touch display screen 120 is also used to display the user's real-time ECG or other cardiac pathological / physiological information. Since directly displaying the ECG would make it difficult for the user to directly understand the cardiac physiological information conveyed by the ECG, in a more preferred embodiment, the touch display screen 120 can directly display whether there is an abnormality in the user's heart state and the type of abnormality based on the real-time ECG, and provide the user with some medical advice, or usage suggestions for the multi-lead real-time ECG monitoring device, such as suggesting that the user switch from the single-lead working state to the multi-lead working state.

[0061] Specifically, the touch screen 120 can display multiple options on its interface, including switching between electrocardiogram, heart status, lead working status, and wireless transmission of electrocardiogram data, so as to facilitate intuitive operation by the user.

[0062] In a preferred embodiment, the wireless communication module 150 can be configured as a Wi-Fi module, Bluetooth module, 3G / 4G / 5G module, etc. The mobile terminal that can receive ECG data can be a mobile phone, tablet computer, or laptop computer, etc. This embodiment does not specifically limit the above-mentioned communication module and / or mobile terminal. Those skilled in the art can use any of the disclosed embodiments in the prior art to realize wireless data transmission.

[0063] In a preferred embodiment, such as Figure 3The wristband 200 has a second multi-lead ECG monitoring element 210 at each end. Both second multi-lead ECG monitoring elements 210 are connected to the computing module 130 and the power supply module 140 through wires embedded in the wristband 200. The two second multi-lead ECG monitoring elements 210 can collect ECG data of the two upper limbs of the human body when not worn. Preferably, the second multi-lead ECG monitoring element 210 and the first multi-lead ECG monitoring element 180 work simultaneously, while the second multi-lead ECG monitoring element 210 and the single-lead ECG monitoring element 110 do not work simultaneously. That is, when the user selects the single-lead working state through the touch screen 120, only the single-lead ECG monitoring element 110 works and acquires single-lead ECG data. When the user selects the multi-lead working state through the touch screen 120, the single-lead ECG monitoring element 110 no longer works, and instead the first multi-lead ECG monitoring element 180 and the two second multi-lead ECG monitoring elements 210 work.

[0064] In a preferred embodiment, both the first multi-lead ECG monitoring element 180 and the second multi-lead ECG monitoring element 210 are configured as metal electrodes. The multiple metal electrodes can contact the left lower limb, left upper limb and right upper limb respectively when not worn, and collect real-time ECG data of six leads of the limbs.

[0065] In a preferred embodiment, the single-lead ECG monitoring element 110 is configured as a pair of resistive sensors that can acquire the resistance of the upper limb (left or right wrist) when the user is wearing the device. The calculation module 130 can calculate the user's single-lead real-time ECG data based on the change in resistance. Alternatively, the calculation module 130 can compare the ECG data with the normal ECG data in the storage module 160 and determine whether there is an abnormality in the user's current ECG data.

[0066] In a more preferred embodiment, the single-lead ECG monitoring element 110 is configured as a photoelectric sensor, which can measure the reflection or absorption data of light in the blood of the upper limb in the wearable state. The calculation module 130 can calculate the user's single-lead real-time ECG data based on the photoelectric data, or the calculation module 130 can compare it with the ECG data in the storage module 160 under normal conditions and determine whether there is any abnormality in the user's current ECG data.

[0067] Specifically, when configuring the single-lead ECG monitoring element 110, a photoelectric sensor is preferably used to avoid the current noise generated by the first multi-lead ECG monitoring element 180 and the second multi-lead ECG monitoring element 210, which are configured as metal electrodes, affecting the resistive sensor and introducing additional interference signals. In addition, the photoelectric sensor uses elements such as photodiodes and photoresistors to measure the light reflection and absorption state of blood flow to calculate ECG data. It does not need to be in contact with the skin and can still collect relatively stable ECG signals under the condition that the wristband 200 is relatively loose. It has relatively strong anti-interference ability against external interference signals.

[0068] Specifically, the photoelectric sensor can be selected from modules such as MAX30100, MAX30102, AFE4400, BH1790GLC, and OsramSFH7050. The specific choice can be made based on factors such as the power consumption requirements or cost budget of the manufacturer, and no further specific restrictions will be made here.

[0069] In a preferred embodiment, the ECG signal acquired by the single-lead ECG monitoring element 110 mainly focuses on the overall heart rate and basic rhythm of the heart, and can detect the timing information of atrial and ventricular contractions. Therefore, the single-lead ECG monitoring element 110 can monitor the temporal abnormalities of the ECG signal (such as atrial fibrillation, premature beats, and other arrhythmias). Preferably, after the single-lead ECG monitoring element 110 acquires the ECG signal, the calculation module 130 can compare the real-time heart rate with the normal heart rate of the user stored in the storage module 160 to determine whether the user's current heart rate is abnormal. When an abnormality is determined, a notification is pushed to the touch screen 120 of the main body 100 or further to other mobile terminals. The notification may include the current heart rhythm and the type of heart rate abnormality, or further suggest that the user perform multi-lead real-time ECG monitoring.

[0070] In a more preferred embodiment, although the single-lead ECG monitoring element 110 only records one direction of cardiac electrical activity, since the ST segment and T wave are common ECG characteristic waveforms that reflect the process of ventricular diastole and repolarization, a single lead can also monitor ST segment and T wave abnormalities. Specifically, when ST segment and T wave abnormalities occur, their waveform characteristics can show some abnormal properties, such as ST segment elevation or depression exceeding the normal range, or T wave inversion, flattening, or widening and blunting. These changes may indicate pathological conditions such as myocardial ischemia, myocardial injury, or electrolyte imbalance. Preferably, after the single-lead ECG monitoring element 110 acquires the ECG signal, the calculation module 130 can assist in assessing the changes in ST segment and T wave based on the acquired ECG signal. When an abnormality is determined, a notification is pushed to the touch screen 120 of the main body 100 or further to other mobile terminals, prompting the user that myocardial ischemia may occur, and suggesting that the user perform multi-lead real-time ECG monitoring.

[0071] In a preferred embodiment, when the user’s single-lead ECG signal is abnormal, the wristband 200 is released, and the second multi-lead ECG monitoring element 210 at both ends of the wristband 200 is held by both hands. The first multi-lead ECG monitoring element 180 at the bottom of the body 100 is attached to the skin of the left lower limb to achieve multi-lead ECG monitoring.

[0072] In a preferred embodiment, when the first multi-lead ECG monitoring element 180 is attached to the skin of the left lower limb, it can be placed in any position on the left lower limb, such as the knee, thigh, or calf, without specific limitation.

[0073] Specifically, when the user holds the second multi-lead ECG monitoring element 210 with both hands and places the first multi-lead ECG monitoring element 180 on the left lower limb, multiple metal electrodes can collect the potential signals of their respective limb surfaces and transmit the potential signals into the calculation module 130 to calculate the potential difference between each metal electrode, thereby obtaining the real-time ECG signal of the six leads of the limb.

[0074] Furthermore, the ECG signal corresponding to lead I can be determined based on the potential difference between the two second multi-lead ECG monitoring elements 210, the ECG signal corresponding to lead II can be determined based on the potential difference between the first multi-lead ECG monitoring element 180 and the second multi-lead ECG monitoring element 210 held in the right hand, and the ECG signal corresponding to lead III can be determined based on the potential difference between the first multi-lead ECG monitoring element 180 and the second multi-lead ECG monitoring element 210 held in the left hand.

[0075] Furthermore, the average potential between the first multi-lead ECG monitoring element 180 and the two second multi-lead ECG monitoring elements 210 is defined as the overall average potential. The ECG signal corresponding to lead aVR can be determined based on the potential difference between the second multi-lead ECG monitoring element 210 held in the right hand and the overall average potential; the ECG signal corresponding to lead aVF can be determined based on the potential difference between the first lead ECG monitoring element placed on the left lower limb and the overall average potential; and the ECG signal corresponding to lead aVL can be determined based on the potential difference between the second multi-lead ECG monitoring element 210 held in the left hand and the overall average potential.

[0076] Based on the aforementioned six-lead electrocardiogram (ECG) signals from the limbs, the potential changes of the heart in various directions of the coronary plane can be determined to identify whether the user has arrhythmias, myocardial ischemia, myocardial injury, ventricular hypertrophy and dilation, electrolyte imbalances, or other lesions. Specifically, after the first-lead ECG monitoring element and the second multi-lead ECG monitoring element 210 acquire ECG signals, the calculation module 130 can compare the six-lead limb ECG with the user's normal ECG stored in the storage module 160 to determine whether there is an abnormality in the ECG corresponding to the user's current six-lead limb ECG. When an abnormality is determined, a notification is pushed to the touch screen 120 of the main body 100 or further to other mobile terminals. The notification may include the type of current cardiac abnormality or further suggest that the user perform real-time ECG monitoring of the six leads in front of the chest.

[0077] Specifically, when the calculation module 130 judges the ECG data collected by the metal electrodes based on the stored normal ECG data, it can make direct judgments based on existing judgment criteria. For example, when the collected ECG data shows ST segment elevation or depression, it can determine whether the user has or is experiencing coronary artery disease such as myocardial ischemia. When the collected ECG data shows the appearance of Q waves, ST segment elevation or depression, and T wave inversion, it can help confirm the part and extent of myocardial damage. When the collected ECG data shows QRS waveforms and ST segment changes, it can determine the degree of ventricular hypertrophy and dilation. When the QT period is prolonged or shortened, it can help determine whether electrolyte disturbances have occurred. And so on, and so forth, which will not be listed in detail in this embodiment.

[0078] In a preferred embodiment, each metal electrode has mechanically engraved or laser-etched markings on its surface, including electrode orientation, to guide the user to place different metal electrodes at different positions on the limb to obtain real-time electrocardiogram data of the limb's six leads.

[0079] Specifically, mechanical scribing or laser etching will not significantly affect the conductivity of the metal electrode surface, so as to avoid noise when acquiring ECG signals. Furthermore, prompt text or patterns for the left lower limb can be added to the surface of the first multi-lead ECG monitoring element 180, and prompt text or patterns for both hands / left hand / right hand can be added to the surface of the two second multi-lead ECG monitoring elements 210 to help users quickly understand how to use it.

[0080] In a preferred embodiment, the multi-lead real-time ECG monitoring device further includes a chest strap 300, on one side of which are six third multi-lead ECG monitoring elements 310. Adjacent third multi-lead ECG monitoring elements 310 are insulated from each other. The third multi-lead ECG monitoring elements 310 can acquire real-time ECG data from six leads on the chest. Preferably, the chest strap 300 can be worn or attached to the user's chest when in use, and can be wrapped and fixed around the outer periphery of the wristband 200 when not in use. The third multi-lead ECG monitoring elements 310 are all configured as metal electrodes, and can specifically use the same specifications as the first multi-lead ECG monitoring element 180 and the second multi-lead ECG monitoring element 210.

[0081] Preferably, the chest strap 300 is embedded with wires connected to the third multi-lead ECG monitoring element 310. Each third multi-lead ECG monitoring element 310 is connected to the main body 100 through a separate wire. The leads of several wires can be connected to the main body 100 to transmit the ECG data acquired by the third multi-lead ECG monitoring element 310 to the calculation module 130. The calculation module 130 can calculate the six-lead ECG on the chest based on the ECG data acquired by the third multi-lead ECG monitoring element 310.

[0082] In a preferred embodiment, the chest strap 300 is strip-shaped, with a nano self-adhesive tape covering the side where the metal electrodes are located. It is washable, movable, and reusable, so that the user can attach the chest strap 300 to the front of the chest.

[0083] In another preferred embodiment, the chest strap 300 is in the form of an elastic loop that can be worn directly on the chest.

[0084] Preferably, a clasp or magnetic buckle can be further provided on the wristband 200, with the specific structure referring to the structure of a watch strap, to fix the chest strap 300 in the non-use state.

[0085] In a preferred embodiment, the six third multi-lead ECG monitoring elements 310 are respectively positioned beside the sternum at the right edge of the fourth intercostal space, beside the sternum at the left edge of the fourth intercostal space, at the left edge of the fifth intercostal space, above the midclavicular line of the fifth intercostal space, at the horizontal position of the midclavicular line of the fifth intercostal space, and below the midclavicular line of the fifth intercostal space.

[0086] Specifically, due to differences in body shape and posture among different users, the positions of the multiple third-lead ECG monitoring elements 310 on the chest strap 300 can be customized. When using it, the user can first determine the placement positions of the third-lead ECG monitoring elements 310 corresponding to leads V1 and V2, that is, beside the sternum at the right and left edges of the fourth intercostal space, and then place the chest strap 300. At this point, the other four third-lead ECG monitoring elements 310 will be in the correct positions. To ensure the accuracy of ECG data, when determining the placement positions of the chest strap 300 for the first time, professional medical personnel are required to assist in determining the placement positions of each third-lead ECG monitoring element 310, so that the user can use it independently in the future.

[0087] When the calculation module 130 simultaneously and in real time acquires the electrocardiogram data of the six leads of the limbs and the six leads of the chest, it can effectively and accurately detect scenarios that require real-time multi-lead electrocardiograms, such as acute myocardial infarction. Specifically, when the electrocardiogram shows characteristic ST segment elevation, Q wave deepening, and corresponding ST segment depression and T wave inversion, it can be determined that the user has experienced myocardial infarction or ischemia, and the user can be alerted through the touch screen 120 or mobile terminal.

[0088] Compared to existing ECG monitoring devices, the multi-lead real-time ECG monitoring device provided in this embodiment is more lightweight and portable. It does not require guidance or interpretation from a professional doctor. Users can view or understand their ECG status in real time, which is conducive to timely detection of heart diseases such as myocardial ischemia (coronary heart disease) and provides ample time for treatment or rescue.

[0089] Example 2

[0090] This invention provides a wearable multi-lead real-time electrocardiogram (ECG) monitoring device, which aims to dynamically adjust the monitoring and alarm levels of the user's ECG according to changes in the external environment to prevent false alarms.

[0091] refer to Figure 5 In a preferred embodiment, the multi-lead real-time ECG monitoring device is configured as a wearable structure, including a main body 100 and a wristband 200 connected thereto. Specifically, the external structure of the device in this embodiment is the same as that in Embodiment 1 above, and the technical features already included in Embodiment 1 above are naturally inherited in this embodiment, and will not be repeated here.

[0092] Preferably, the structure of the main body 100 includes a computing module 130, a power supply module 140, a touch display screen 120, a wireless communication module 150, and a storage module 160. In addition, the main body 100 is further provided with an environmental sensor 170. The addition of the environmental sensor 170 can help the wearable multi-lead real-time electrocardiogram monitoring device reduce false alarms caused by environmental factors, and can also assist the computing module 130 in predicting the probability of disease occurrence based on environmental factors.

[0093] In a preferred embodiment, the environmental sensor 170 can be configured as one or more of a temperature sensor, humidity sensor, barometric pressure sensor, gyroscope, or sound sensor. Each sensor can acquire characteristic environmental parameters and input the acquired parameters into the calculation module 130 to help it determine whether there are drastic changes in the current environment, thereby improving the monitoring level of electrocardiographic activity.

[0094] Taking a barometric pressure sensor as an example, when the ambient air pressure is detected to be low, the oxygen content in the air will also be low, which may increase the risk of heart attack. For users with pre-existing cardiovascular disease, low air pressure may increase the workload on the heart and lead to heart attacks. In this case, the calculation module 130 can improve the accuracy or frequency of ECG acquisition of the first multi-lead ECG monitoring element 180 and the second multi-lead ECG monitoring element 210 to improve the warning level for the user. When the air pressure is detected to be high, the oxygen content in the air is relatively high, which will have a positive impact on heart health. Therefore, the calculation module 130 can reduce the accuracy or frequency of ECG acquisition of the first multi-lead ECG monitoring element 180 and the second multi-lead ECG monitoring element 210 to reduce the warning level for the user.

[0095] Taking a temperature sensor as an example, when the ambient temperature is detected to rise or fall sharply in a short period of time, or when the ambient temperature remains high or low for a period of time, it may increase the burden on the heart and increase the risk of heart attack. At this time, the calculation module 130 can improve the accuracy or frequency of ECG acquisition of the first multi-lead ECG monitoring element 180 and the second multi-lead ECG monitoring element 210 to improve the warning level for the user.

[0096] In a preferred embodiment, the mobile terminal can obtain information such as latitude, longitude, altitude, weather, and air quality index through network services. The main body 100 can obtain this information based on the wireless communication module 150 and transmit it to the computing module 130. The computing module 130 predicts the probability of heart disease occurrence based on environmental factors such as season, temperature, humidity, and air quality. The prediction logic can refer to the above-described implementation with added environmental sensor 170. For example, winter and cold weather may increase the risk of cardiovascular and cerebrovascular diseases, and high humidity in summer may also increase the risk of certain diseases. In this case, the computing module 130 increases the ECG acquisition accuracy or frequency of the first multi-lead ECG monitoring element 180 and the second multi-lead ECG monitoring element 210, or increases the warning level for the user, to ensure the golden treatment time. When the user is in a calm state or in a comfortable environment at room temperature, the computing module 130 decreases the ECG acquisition accuracy or frequency of the first multi-lead ECG monitoring element 180 and the second multi-lead ECG monitoring element 210, or decreases the warning level for the user, to avoid false positives.

[0097] In a preferred embodiment, the relationship between the warning level of the multi-lead real-time ECG monitoring device and environmental parameters is shown in Table 1 below:

[0098] Environmental parameters Interval values Interval values Interval values Temperature 34-38℃ or -10-15℃: +2 38℃-40℃ or -20℃--25℃: +3 Above 40°C or below -25°C: +5 Temperature change rate The temperature change within 24 hours is between 8-10℃ and +4℃. The temperature change within 24 hours is 10-12℃ +6℃. Temperature change exceeding 12°C within 24 hours: +8 air pressure 0.9-0.95 atmospheres: +2 0.8-0.9 atmospheres: +6 Below 0.8 atmospheres: +10 humidity 95-105％：+1 Greater than 105-120%: +2 Greater than 120%: +3 Air Quality Index PMI index 100-150: +1 PMI index 150-250: +2 PMI index 250-500: +6 Intense Exercise Index Vigorous exercise within 120 minutes: +2 Vigorous exercise within 60 minutes: +4 Vigorous exercise within 30 minutes or immediately: +6 Comprehensive sum value 12 23 38

[0099] Table 1

[0100] When the ECG warning signal is at the critical value, if the sum of the values ​​is less than or equal to 12, warnings are not recommended at the critical value to avoid false positives; if the sum of the values ​​is between 13 and 23, a warning will be sent to the user; if the sum of the values ​​is greater than 24, a warning will be sent to the user, doctors, ambulances, etc.

[0101] In a preferred embodiment, when the computing module 130 receives environmental parameters from the environmental sensor 170 or the wireless communication module 150, it can issue an early warning based on the environmental data and electrocardiogram data, and display it on the touch screen 120. Preferably, when displaying the early warning information on the touch screen 120, it also includes the corresponding warning level and environmental data, as well as how these conditions may affect their health status.

[0102] The technical solution of this embodiment not only integrates environmental factors into the wearable multi-lead real-time electrocardiogram monitoring device, but also enables the device to predict the probability of heart disease occurrence based on environmental conditions, helping users to more accurately predict and prevent diseases.

[0103] Example 3

[0104] This embodiment provides a multi-lead real-time electrocardiogram monitoring method. This method utilizes the multi-lead real-time electrocardiogram monitoring device disclosed in Embodiment 1 above. The technical features already included in Embodiment 1 above are naturally inherited in this embodiment and will not be repeated here.

[0105] In a preferred embodiment of this example, the multi-lead real-time electrocardiogram monitoring method includes the following steps:

[0106] Step S210: Acquire photoelectric signals from the upper limb based on a single-lead ECG monitoring element.

[0107] In a preferred embodiment, the single-lead ECG monitoring element 110 is selected as a photoelectric sensor to avoid the current noise generated by the first multi-lead ECG monitoring element 180 and the second multi-lead ECG monitoring element 210, which are configured as metal electrodes, from affecting the resistive sensor and introducing additional interference signals. In addition, the photoelectric sensor uses components such as photodiodes and photoresistors to measure the light reflection and absorption state of blood flow to calculate ECG data. It does not need to be in contact with the skin and can still collect relatively stable ECG signals under the condition that the wristband 200 is relatively loose. It has relatively strong anti-interference ability against external interference signals.

[0108] Step S220: Determine whether there is an abnormality in the single-lead real-time ECG based on the photoelectric signal.

[0109] In a preferred embodiment, the ECG signal acquired by the single-lead ECG monitoring element 110 mainly focuses on the overall heart rate and basic rhythm of the heart. It can detect the timing information of atrial and ventricular contractions and monitor the temporal abnormalities of the ECG signal (such as atrial fibrillation, premature beats, and other arrhythmias). Preferably, after the single-lead ECG monitoring element 110 acquires the ECG signal, the calculation module 130 can compare the real-time heart rate with the normal ECG data of the user stored in the storage module 160. At the same time, it can assist in evaluating changes in ST segment, T wave, etc., to determine whether the user's current heart rate is abnormal, or whether the user has myocardial ischemia, myocardial injury, or electrolyte imbalance. When an abnormality is determined, a notification is pushed to the touch screen 120 of the main body 100 or further to other mobile terminals. The notification may include the type of current heart rate abnormality, or prompt the user that the user is currently in a state of myocardial ischemia, or further suggest that the user perform multi-lead real-time ECG monitoring.

[0110] In a preferred embodiment, step S220 further includes:

[0111] The warning level and intensity are dynamically adjusted according to changes in the external environment. Specifically, this step is detailed in Example 2 above and will not be repeated here.

[0112] Step S230: When an abnormality is detected, remind the user to release the wristband and acquire the first potential signals of the left lower limb and both upper limbs based on the first multi-lead ECG monitoring element and the second multi-lead ECG monitoring element, respectively.

[0113] In a preferred embodiment, step S230 further includes: attaching the first multi-lead ECG monitoring element 180 to any part of the left lower limb; and holding the second multi-lead ECG monitoring element 210 at both ends of the wristband 200 with both hands.

[0114] In a preferred embodiment, the first potential signal includes the electrocardiogram signals corresponding to leads I, II, III, aVR, aVL, and aVF, respectively.

[0115] Step S240: Calculate the real-time electrocardiogram data of the six leads of the limbs based on the first potential signal.

[0116] In a preferred embodiment, based on the aforementioned six-lead electrocardiogram (ECG) signals from the limbs, the potential changes of the heart in various directions of the coronary plane can be determined to identify whether the user has arrhythmias, myocardial ischemia, myocardial injury, ventricular hypertrophy and dilation, electrolyte imbalances, or other lesions. Specifically, after the first-lead ECG monitoring element and the second multi-lead ECG monitoring element 210 acquire ECG signals, the calculation module 130 can compare the six-lead limb ECG with the user's normal ECG stored in the storage module 160 to determine whether there is an abnormality in the ECG corresponding to the user's current six-lead limb ECG. When an abnormality is determined, a notification is pushed to the touch screen 120 of the main body 100 or further to other mobile terminals. The notification may include the type of current cardiac abnormality or further suggest that the user perform real-time ECG monitoring with six leads in the chest.

[0117] Preferably, it further includes:

[0118] Step S250: Release the chest strap and wear or attach it to the chest.

[0119] In a preferred embodiment, the six third multi-lead ECG monitoring elements 310 on the chest strap 300 are respectively positioned beside the sternum at the right edge of the fourth intercostal space, beside the sternum at the left edge of the fourth intercostal space, at the left edge of the fifth intercostal space, above the midclavicular line of the fifth intercostal space, at the horizontal position of the midclavicular line of the fifth intercostal space, and below the midclavicular line of the fifth intercostal space.

[0120] Step S260: Acquire the second potential signal based on the third multi-lead ECG monitoring element.

[0121] In a preferred embodiment, the second potential signal includes the electrocardiogram signals corresponding to leads V1, V2, V3, V4, V5, and V6, respectively.

[0122] Step S270: Calculate the real-time electrocardiogram data of the chest leads based on the second potential signal.

[0123] Preferably, when the calculation module 130 simultaneously and in real time acquires the electrocardiogram data of the six leads of the limbs and the six leads of the chest, it can effectively and accurately detect scenarios such as acute myocardial infarction that require real-time multi-lead electrocardiogram detection. Specifically, when the electrocardiogram shows characteristic ST segment elevation, Q wave deepening, and corresponding ST segment depression and T wave inversion, it can be determined that the user has experienced myocardial infarction or ischemia, and the user can be alerted through the touch screen 120 or mobile terminal.

[0124] In this embodiment, the user monitors their own electrocardiogram in real time based on the multi-lead real-time electrocardiogram monitoring device disclosed in Embodiment 1 above. This allows the user to know their heart physiological status in a timely manner, and to confirm the onset of disease immediately. This is beneficial for the timely detection of heart diseases such as myocardial ischemia (coronary heart disease) and provides sufficient time for treatment or rescue.

[0125] Although exemplary embodiments have been described herein with reference to the accompanying drawings, it should be understood that the above exemplary embodiments are merely illustrative and are not intended to limit the scope of this application. Various changes and modifications can be made therein by those skilled in the art without departing from the scope and spirit of this application. All such changes and modifications are intended to be included within the scope of this application as claimed in the appended claims.

[0126] Numerous specific details are set forth in the specification provided herein. However, it will be understood that embodiments of this application may be practiced without these specific details. In some instances, well-known methods, structures, and techniques have not been shown in detail so as not to obscure the understanding of this specification.

[0127] Similarly, it should be understood that, in order to streamline this application and aid in understanding one or more of the various inventive aspects, features of this application may sometimes be grouped together in a single embodiment, figure, or description thereof in the description of exemplary embodiments of this application. However, this approach should not be construed as reflecting an intention that the claimed application requires more features than are expressly recited in each claim. Rather, as reflected in the corresponding claims, its inventive point lies in solving the corresponding technical problem with features fewer than all features of a single disclosed embodiment. Therefore, the claims following the detailed description are hereby expressly incorporated into that detailed description, wherein each claim itself is a separate embodiment of this application.

[0128] Those skilled in the art will understand that, apart from the mutual exclusion of features, all features disclosed in this specification (including the accompanying claims, abstract, and drawings) and all processes or elements of any method or apparatus so disclosed can be combined in any combination. Unless otherwise expressly stated, each feature disclosed in this specification (including the accompanying claims, abstract, and drawings) may be replaced by an alternative feature serving the same, equivalent, or similar purpose.

Claims

1. A multi-lead real-time electrocardiogram monitoring device, characterized in that, Includes the main body and the wristband connected to it; The bottom of the main body can contact the upper limb surface of the human body when worn. The bottom of the main body is provided with a single-lead ECG monitoring element and a first multi-lead ECG monitoring element at intervals. The single-lead ECG monitoring element can collect ECG data of the human upper limb when worn, and the first multi-lead ECG monitoring element can collect ECG data of the human left lower limb when not worn. The single-lead ECG monitoring element and the first multi-lead ECG monitoring element work alternately. The main body is equipped with a computing module and a power supply module, both of which are connected to the single-lead ECG monitoring element and the first multi-lead ECG monitoring element, respectively. When not worn, the wristband is a strip-shaped structure. When worn, the two ends of the wristband can be connected end to end to form a loop. Each end of the wristband is equipped with a second multi-lead ECG monitoring element. Both second multi-lead ECG monitoring elements are connected to the computing module and the power supply module through wires embedded in the wristband. The two second multi-lead ECG monitoring elements can collect ECG data of the two upper limbs of the human body when not worn.

2. The multi-lead real-time electrocardiogram monitoring device according to claim 1, characterized in that, The single-lead ECG monitoring element is configured as a photoelectric sensor, which can measure the reflection or absorption data of light in the blood of the upper limb when worn. The calculation module can calculate the user's single-lead real-time ECG data based on the photoelectric data.

3. The multi-lead real-time electrocardiogram monitoring device according to claim 1, characterized in that, The single-lead ECG monitoring element is configured as a pair of resistive sensors, which can acquire the resistance of the upper limb when worn, and the calculation module can calculate the user's single-lead real-time ECG data based on the change in resistance.

4. The multi-lead real-time electrocardiogram monitoring device according to claim 1, characterized in that, Both the first multi-lead ECG monitoring element and the second multi-lead ECG monitoring element are configured with metal electrodes; Multiple metal electrodes can contact the left lower limb, left upper limb, and right upper limb respectively when not worn, and collect real-time six-lead electrocardiogram data of the limbs; each metal electrode has mechanically engraved or laser-etched usage markings on its surface, the usage markings including the direction of the electrode, to guide the user to place different metal electrodes in different positions of the limbs to obtain real-time six-lead electrocardiogram data of the limbs.

5. The multi-lead real-time electrocardiogram monitoring device according to claim 1, characterized in that, The main body is also equipped with a storage module, which is connected to the computing module. The storage module can record the user's single-lead ECG data and multi-lead ECG data respectively. The body also includes a wireless communication module, which is connected to the computing module and is used to transmit the acquired real-time electrocardiogram data to a mobile terminal. The main body is also equipped with a touch screen display, which is connected to the computing module and used to switch the working state of the single-lead ECG monitoring element and the first multi-lead ECG monitoring element.

6. The multi-lead real-time electrocardiogram monitoring device according to claim 1, characterized in that, It also includes a chest strap, which is strip-shaped and can be worn or attached to the user's chest when in use, and wrapped around the outer periphery of the wristband when not in use. One side of the chest strap is provided with six third multi-lead ECG monitoring elements, which can acquire real-time ECG data of six leads in front of the chest. Each of the aforementioned third multi-lead ECG monitoring elements is configured as a metal electrode, and each of the aforementioned third multi-lead ECG monitoring elements is connected to the main body via a separate wire. An insulating gap is provided between adjacent third multi-lead ECG monitoring elements. The chest strap is embedded with a wire connected to the third multi-lead ECG monitoring element. The lead-out terminals of the wire can be connected to the main body to transmit the ECG data acquired by the third multi-lead ECG monitoring element to the calculation module. The six third multi-lead ECG monitoring elements are respectively positioned at the right edge of the fourth intercostal space beside the sternum, the left edge of the fourth intercostal space beside the sternum, the left edge of the fifth intercostal space, above the midclavicular line of the fifth intercostal space, at the horizontal position of the midclavicular line of the fifth intercostal space, and below the midclavicular line of the fifth intercostal space.

7. A real-time electrocardiogram (ECG) monitoring method using the multi-lead real-time ECG monitoring device according to any one of claims 1-6, characterized in that, include: Photoelectric signals from the upper limbs are acquired using a single-lead ECG monitoring element; The presence of abnormalities in a single-lead real-time electrocardiogram is determined based on the photoelectric signal. When an abnormality is detected, the user is reminded to release the wristband. The first potential signal of the left lower limb and the two upper limbs is obtained based on the first multi-lead ECG monitoring element and the second multi-lead ECG monitoring element, respectively. Calculate the real-time electrocardiogram data of the limbs using the first potential signal.

8. The real-time electrocardiogram monitoring method according to claim 7, characterized in that, The step of determining whether there is an abnormality in a single-lead real-time electrocardiogram based on the photoelectric signal further includes: The warning level and intensity are dynamically adjusted according to changes in the external environment; The step of reminding the user to release the wristband also includes: The first multi-lead ECG monitoring element is attached to any part of the left lower limb; Hold the second multi-lead ECG monitoring element at each end of the wristband with both hands.

9. The real-time electrocardiogram monitoring method according to claim 7, characterized in that, After the step of calculating the real-time electrocardiogram data of the six leads of the limb based on the first potential signal, the method further includes: Release the chest strap and wear or attach it to your chest; The second potential signal is obtained based on the third multi-lead ECG monitoring element; Real-time ECG data for the chest leads are calculated based on the second potential signal.

10. The real-time electrocardiogram monitoring method according to claim 9, characterized in that, The first potential signal includes the electrocardiogram signals corresponding to leads I, II, III, aVR, aVL, and aVF, respectively; the second potential signal includes the electrocardiogram signals corresponding to leads V1, V2, V3, V4, V5, and V6, respectively.

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