WO2021143945A1

WO2021143945A1 - Portable 12-lead electrocardiograph signal acquisition device, and method of using same

Info

Publication number: WO2021143945A1
Application number: PCT/CN2021/079631
Authority: WO
Inventors: 曹丰; 王慧泉; 张继彬; 曹瑞华
Original assignee: 中国人民解放军总医院第二医学中心
Priority date: 2020-01-16
Filing date: 2021-03-09
Publication date: 2021-07-22
Also published as: CN111134657A

Abstract

A portable 12-lead electrocardiograph signal acquisition device. The device comprises a control unit, an electrocardiograph signal acquisition unit, a wireless transmission unit, 10 electrodes, and a right-hand glove; the control unit, the electrocardiograph signal acquisition unit, and the wireless transmission unit are arranged on the back side of the right-hand glove; the 10 electrodes are used for contacting a user body surface and are arranged on the outer portion of the palm side of the right-hand glove; upon putting on the right-hand glove, the user determines the distribution of the 10 electrodes with respect to the position of the heart of a patient on the basis of the size of the right hand palm of said user; the 10 electrodes are each connected to the electrocardiograph signal acquisition unit by means of lead wires; and the electrocardiograph signal acquisition unit collects original electrocardiograph signals received via the 10 electrodes, converts the signals into electrocardiograph data by means of a microcontroller, and sends out the electrocardiograph data via the wireless transmission unit. By skillfully arranging the 10 electrodes on the right-hand glove, and by matching hand size to heart size, the present invention solves the problem of different user body shapes requiring different electrode positioning.

Description

Portable 12-lead ECG signal acquisition device and its use method

Technical field

The invention relates to an ECG signal acquisition technology, in particular to a portable 12-lead ECG signal acquisition device and a method of use thereof.

Background technique

Cardiovascular disease is one of the main diseases threatening human life and health, with sudden and high risk. Continuous monitoring of ECG signals is the most effective way to prevent and treat cardiovascular diseases.

In order to observe the activity of the heart from different angles, 12-lead electrocardiogram is usually used internationally to reflect the changes in the frontal and transverse ECG, and it is used as an important diagnosis of clinical arrhythmia, myocardial infarction, myocarditis and other cardiovascular diseases in accordance with. At present, the ECG monitor commonly used clinically mainly records the heart activity of the human body at rest. Due to the limited recording time, it is difficult to detect early patient-related diseases during the monitoring process, and it is more difficult to record abnormal changes in the ECG that occur only once in several days or weeks. In addition, the large size of the instrument makes it inconvenient to carry around, making it impossible for the majority of out-of-hospital patients, especially early patients with mild symptoms, to make timely and accurate diagnosis, thus delaying the opportunity for diagnosis and treatment, and it is difficult to obtain early treatment and effective control of the disease.

With the development of integrated circuits, various portable Holter detection devices emerge in endlessly. The patent with the domestic announcement number 207152589U proposes a Holter signal acquisition device, which realizes the dynamic monitoring of the ECG signal and can be wirelessly transmitted, which is convenient to carry. However, the device has only one electrode, which cannot fully monitor the heart activity, and because the PCB hardware circuit is implanted in the device, the flexible electrode cannot fully fit the human body curve to a certain extent, and it often loosens and falls off. In addition, the lead electrodes of the ECG signal acquisition device are generally attached by professionals or require patients to acquire relevant knowledge in advance, which is inconvenient to use.

The domestic patent publication No. 108523878 A proposes a wearable ECG monitoring terminal product, which embeds 10 fabric electrodes inside the high elastic underwear, and adopts a 12-lead measurement method to ensure that the electrodes and the skin are fully monitored while monitoring the heart. Close contact, and the patient does not need to consider the placement position of the detection electrode. However, the device cannot avoid the interference of myoelectricity and motion artifacts generated when the electrode is rubbed against the human skin for a long time, and because the body types of different patients are quite different, and the industrialized vests generally have only a few models, which cannot guarantee a perfect match with the patient's body type. Therefore, the wearable ECG monitoring terminal products of this technology cannot guarantee the accurate positioning of the electrodes on the body surface of different patients.

To sum up, although the current portable ECG acquisition device, although the signal acquisition and processing technology is basically mature, there are always defects in the stable contact and accurate positioning of the patient's body surface, and the same acquisition device is difficult to adapt to patients of different body types. .

Disclosure of invention

In view of the above-mentioned problems, this application aims to propose a portable 12-lead ECG signal acquisition device, which can form stable contact with the patient's body surface on the one hand, and on the other hand can be adapted to patients of different body types and accurately positioned.

The portable 12-lead ECG signal acquisition device of the present application includes: a control unit, an ECG signal acquisition unit, a wireless transmission unit, 10 electrodes, and a right glove;

The control unit, the ECG signal acquisition unit, and the wireless transmission unit are arranged on the back side of the right glove;

10 electrodes, used to contact the body surface of the user, are arranged outside the palm side of the right glove. After the user wears the right glove, the size of the user's right palm determines the position of the 10 electrodes at the heart of the patient The distribution of the 10 electrodes are respectively connected to the ECG signal acquisition unit through wires;

The ECG signal acquisition unit collects the original ECG signals received from the 10 electrodes, converts them into ECG data by the microcontroller, and sends them to the outside by the wireless transmission unit.

Preferably, the 10 electrodes are fabric electrodes.

Preferably, the fabric electrode is processed by a chlorination process.

Preferably, the right glove is made of elastic material.

Preferably, among the 10 electrodes,

The first electrode is located at the base of the thumb to measure the electrical signal of V1;

The second electrode is located at the base of the index finger close to the base of the thumb, and is used to measure the electrical signal of V2;

The third electrode is located near the intersection of the root of the middle finger and the root of the ring finger, and is used to measure the electrical signal of V3;

The fourth electrode is located at the first knuckle of the ring finger and is used to measure the electrical signal of V4;

The fifth electrode is located at the second knuckle of the ring finger and is used to measure the electrical signal of V5;

The sixth electrode is located at the third knuckle of the ring finger and is used to measure the electrical signal of V6;

The seventh electrode is located at the fingertip of the thumb to measure the electrical signal of RA;

The eighth electrode is located at the tip of the index finger to measure the electrical signal of LA;

The ninth electrode is located at the fingertip of the little finger and is used to measure the electrical signal of LL;

The tenth electrode is located at the lower right of the palm near the wrist and is used to measure the electrical signal of RL.

Preferably, a sandwich is formed on the back side of the right glove; the control unit, the ECG signal acquisition unit, and the wireless transmission unit are arranged on a flexible circuit board; the flexible circuit board and the control unit and the ECG on the flexible circuit board The signal acquisition unit and the wireless transmission unit are accommodated in the interlayer.

Preferably, the wireless transmission unit performs wireless communication through Bluetooth, WIFI, or Zigbee.

This application also aims to propose a method for using the aforementioned portable 12-lead ECG signal acquisition device, which includes the following steps:

The portable 12-lead ECG signal acquisition device establishes a wireless connection with external terminal equipment;

The right glove worn on the user’s right hand is attached to the user’s left chest with the five fingers spread out. The center of the palm of the right glove is located in the middle of the user’s sternum, and the height is level with the heart; the thumb of the right glove extends to the upper right, Extend the index finger to the upper left, the thumb tip and the index finger tip at the same height; the middle finger and ring finger extend naturally, and the ring finger tip is close to the left front axillary line; the little finger stretches toward the lower left; making the 10 electrodes directly contact the user's skin ；

The ECG acquisition module collects the original ECG signals transmitted by the 10 electrodes, converts them into ECG data by the microcontroller, and finally transmits the ECG data to external terminal equipment through the wireless transmission unit.

Brief description of the drawings

Fig. 1 is a block diagram of the circuit principle of the portable 12-lead ECG signal acquisition device of this application;

2 is a schematic diagram of the position arrangement of the fabric electrodes of the portable 12-lead ECG signal acquisition device of the application on the palm side of the right glove;

Fig. 3 is a schematic diagram of the arrangement of the connecting wires and the control circuit of the portable 12-lead ECG signal acquisition device of the application on the back side of the right glove;

Fig. 4 is a schematic diagram of the position arrangement of the connecting wires of the portable 12-lead ECG signal acquisition device of Fig. 3 on the palm side of the right glove.

The best way to implement the invention

Hereinafter, the portable 12-lead ECG signal acquisition device of the present application will be described in detail with reference to the accompanying drawings.

10 electrodes, used to contact the body surface of the user, are set outside the palm side of the right glove. After the user wears the right glove, the size of the user's right palm determines the position of the 10 electrodes at the heart of the patient The distribution of the 10 electrodes are respectively connected to the ECG signal acquisition unit through wires;

The 10 electrodes can be general electrodes or fabric electrodes. In the case of fabric electrodes, the fabric electrodes undergo a chlorination process.

The right glove can be formed into multiple specifications, such as S, M, L, XL, etc., and more preferably, it is made of an elastic material that is willing to stretch, so that the right glove can automatically adapt to the palm of the user.

Among the 10 electrodes, the first electrode is located at the base of the thumb to measure the electrical signal of V1; the second electrode is located at the base of the index finger close to the base of the thumb to measure the electrical signal of V2; the third electrode is located at The intersection of the root of the middle finger and the root of the ring finger is used to measure the electrical signal of V3; the fourth electrode is located at the first knuckle of the ring finger to measure the electrical signal of V4; the fifth electrode is located at the second knuckle of the ring finger to measure the electrical signal of V4. Measure the electrical signal of V5; the sixth electrode is located at the third knuckle of the ring finger to measure the electrical signal of V6; the seventh electrode is located at the tip of the thumb to measure the electrical signal of RA; the eighth electrode is located at the tip of the index finger It is used to measure the electrical signal of LA; the ninth electrode is located at the fingertip of the little finger to measure the electrical signal of LL; the tenth electrode is located at the lower right of the palm near the wrist to measure the electrical signal of RL.

An interlayer is formed on the back side of the right glove; the control unit, the ECG signal acquisition unit, and the wireless transmission unit are arranged on the flexible circuit board; the flexible circuit board and the control unit, the ECG signal acquisition unit, and the wireless transmission unit are housed in the interlayer .

The wireless transmission unit may be any of the wireless transmission technologies in the prior art, such as Bluetooth, WIFI, or Zigbee.

When using the portable 12-lead ECG signal acquisition device of the present application, the portable 12-lead ECG signal acquisition device establishes a wireless connection with an external terminal device;

The circuit principle block diagram of the portable 12-lead ECG signal acquisition device of the present application is shown in FIG. 1. On the basis of the normal power supply by the power module 4, the ECG signal detected by the fabric electrode 5 is first amplified and filtered by the ECG signal acquisition unit 2, and then converted into a digital signal, which is communicated by SPI serial The method is transmitted to the control unit 1 implemented by MCU. The MCU sends the re-filtered digital signal to the external terminal device 6, that is, the upper computer, through the wireless transmission unit 3 implemented by the Bluetooth module, for waveform display.

Each fabric electrode has a connecting wire. Specifically, the first electrode E-V1 is connected to the first wire L-1, the second electrode E-V2 is connected to the second wire L-2, and the third electrode E-V3 is connected to the The third lead L-3 is connected, the fourth electrode E-V4 is connected to the fourth lead L-4, the fifth electrode E-V5 is connected to the fifth lead L-5, and the sixth electrode E-V6 is connected to the sixth lead L- 6 is connected, the seventh electrode E-RA is connected to the seventh lead L-7, the eighth electrode E-LA is connected to the eighth lead L-8, the ninth electrode E-LL is connected to the ninth lead L-9, and the tenth The electrode E-RL is connected to the ninth wire L-10. Each wire is connected to the ECG signal acquisition unit 2, and no interlayer is provided on the palm side of the right glove.

The ECG signal acquisition unit can use a digital analog physiological signal processing chip ADS1298 produced by TI, which is based on a high-precision signal sampling method. The chip has a 3.3V unipolar power supply and is highly integrated with a high-speed data conversion channel composed of 8-route EMI filters, programmable gain amplifiers (PGA), and 24-bit analog-to-digital converters. It also integrates a right leg drive circuit (RLD). , Wilson Center Detection Circuit (WCT), Leadoff Detection Circuit (Leadoff Detection) and other commonly used functional circuits for 12-lead ECG detection, combined with the typical peripheral circuits provided in the manual, can achieve ECG signal acquisition in a relatively streamlined manner.

The control unit can use STM32F103 series chips with ARM as the core, and can choose STM32F103RCT6, STM32F103VET6 and other moderate performance chips, refer to the minimum system to draw the microcontroller circuit, and 5V power supply.

The wireless transmission unit can use the CC2541 Bluetooth chip to realize the wireless data transmission between the microcontroller and the Bluetooth on the terminal device, 5V power supply, and get rid of the uncomfortable situation of the patient being wired.

The terminal device displays and saves the received ECG data in real time in the form of a GUI interface, which can be used by doctors for diagnosis and analysis of historical data.

The power supply module uses 12V rechargeable power supply, which is reduced to 5V through the 7805 voltage regulator chip, and then down to 3.3V through the REF3033 chip to meet the power supply requirements of all modules.

Studies have shown that the heart of a normal person is about the same size as their own fist, and the size of their own hands is used to determine the specific range of the detection of the ECG, which has extremely high adaptability. The portable 12-lead ECG signal acquisition device of the present application uses a stretchable fabric glove as a carrier, and utilizes the elasticity of the glove to automatically adapt the position of the fabric electrode to the ECG detection position of the patient's body surface, thereby realizing accurate positioning of the fabric electrode. In the twelve-lead system, 10 electrodes need to be placed on the surface of the human body in the left arm (LA), right arm (RA), left leg (LL), right leg (RL) and chest V1-V6. The specific positions of the above electrodes on the body surface of the human body are as follows:

V1 is located in the fourth intercostal space on the right edge of the sternum; V2 is located in the fourth intercostal space on the left edge of the sternum; V3 is located at the midpoint of the connection line between V2 and V4; V4 is located in the fifth intercostal space on the left mid-clavicular line; V5 is located at the left front axillary line flush with V4 V6 is located at the intersection of the left mid-axillary line and V4 flush; LA is located close to the left shoulder; RA is located close to the right shoulder; LL is located on the midline connecting LA and RA.

When recording an electrocardiogram, the right leg electrode is generally a reference electrode, and there is no accurate position. LA, RA, and LL need to form an equilateral triangle with the heart as the center. Corresponding to the above-mentioned clinical measurement standards, the inventor of the present application found the arrangement positions of 10 fabric electrodes on the gloves, as shown in FIG. 2.

The first electrode E-V1 at the base of the thumb is used to measure the electrical signal of V1; the second electrode E-V2 located at the base of the index finger close to the base of the thumb is used to measure the electrical signal of V2; at the base of the middle finger and The third electrode E-V3 at the intersection of the ring finger root is used to measure the electrical signal of V3; the fourth electrode E-V4 at the first knuckle of the ring finger is used to measure the electrical signal of V4; the fifth electrode at the second knuckle of the ring finger Electrode E-V5 is used to measure the electrical signal of V5; the sixth electrode E-V6 at the third knuckle of the ring finger is used to measure the electrical signal of V6; the seventh electrode E-RA at the fingertip of the thumb is used to measure the electrical signal of RA Electrical signal; the eighth electrode E-LA at the fingertip of the index finger is used to measure the electrical signal of LA; the ninth electrode E-LL at the fingertip of the little finger is used to measure the electrical signal of LL; the tenth electrode at the bottom right of the palm near the wrist Electrode E-RL is used to measure the electrical signal of RL.

After wearing the portable 12-lead ECG signal acquisition device of the present application, the user needs to ensure that the tip of the thumb and index finger are on the same horizontal line during the placement of the right hand, from the base of the thumb to the tip of the ring finger. Natural arc. Corresponding to the position of the fabric electrode, install the integrated flexible PCB circuit in the interlayer of the back of the glove, and arrange the connecting wires on the back of the glove reasonably according to the principle of proximity, as shown in Figure 3.

The method of use is as follows:

The terminal device turns on Bluetooth and waits for pairing with the Bluetooth of the collection front end;

Turn on the power switch on the glove, make sure that each module is normally powered, and establish a connection with the Bluetooth on the terminal device, the indicator double flashes to indicate a successful connection;

The patient put on a glove on his right hand, spread his fingers tightly on his left chest, in direct contact with the skin, without clothing. Try to ensure that the center of the palm is in the middle of the sternum, and the height is level with the heart; the thumb is stretched toward the upper right and the index finger is stretched toward the upper left. Adjust the angle of the right hand to ensure that the tip of the thumb is at the same height as the tip of the index finger; the middle and ring fingers are naturally stretched , To ensure that the base of the thumb to the ring fingertips form a natural arc, and the ring fingertips are as close as possible to the left front axillary line; the little finger extends to the lower left, try to ensure that the position of the pinky fingertip is on the midline connecting the thumb and index fingertips ；

The ECG acquisition module collects the original ECG signal, converts it into ECG data by the microcontroller, and performs digital filtering on it, and finally transmits the valid data to the terminal device via Bluetooth;

The terminal device performs waveform display on the ECG data and saves it to the fixed folder of the terminal device in time.

The portable 12-lead ECG signal acquisition device of the present application can ensure the comprehensive and accurate results. The detection device using gloves as a carrier meets the requirements of portability and can be used for long-term uninterrupted dynamic ECG monitoring for patients. The patient does not need to have a professional knowledge of the placement position of the electrode, and the general applicability and spreadability are stronger.

The elasticity of fabric electrodes and fabric gloves is used to achieve accurate positioning of detection electrodes, which is fast and effective, and strives for more rescue time for patients with sudden cardiovascular diseases. Compared with ordinary flat electrodes, fabric electrodes are more in line with the body surface curve of the human body, ensuring that the electrodes are in close contact with the human skin, thereby improving the quality of the original electrical signals.

Use wireless data transmission to get rid of the inconvenience of being wired. The signal acquisition, processing and transmission circuits are integrated on the flexible PCB to improve the comfort of the patient experience.

Unless otherwise defined, all technical and/or scientific terms used in this application have the same meaning as commonly understood by those of ordinary skill in the field to which the present invention relates. The materials, methods and examples mentioned in this application are only illustrative and not restrictive.

Although the present invention has been described in conjunction with the specific embodiments, those skilled in the art can make appropriate substitutions, modifications and changes under the subject matter of the invention, and such substitutions, modifications and changes still fall within the protection scope of the present application.

Industrial applicability

The portable 12-lead ECG signal acquisition device of the present application solves the problem of different electrode positions for users of different body types by cleverly setting 10 electrodes on the right glove and using the correspondence between the size of the hand and the size of the heart. ; Because the right glove can be formed of elastic fabric, so that the same glove, without changing any settings, can adapt to the electrode distribution and settings of users of different body types. In addition, since the right glove is used to directly contact the user's body surface, the electrode is in stable contact with the patient's body surface, and there is no interference of myoelectricity and motion artifacts.

Claims

A portable 12-lead ECG signal acquisition device, which is characterized by comprising: a control unit, an ECG signal acquisition unit, a wireless transmission unit, 10 electrodes, and a right glove;

The control unit, the ECG signal acquisition unit, and the wireless transmission unit are arranged on the back side of the right glove; 10 electrodes are used to contact the user's body surface and are arranged on the palm side of the right glove. The user wears the right glove Then determine the distribution of the 10 electrodes at the position of the patient's heart by the size of the palm of the user's right hand; the 10 electrodes are respectively connected to the ECG signal acquisition unit through wires;

The ECG signal acquisition unit collects the original ECG signals received from the 10 electrodes, converts them into ECG data by the microcontroller, and sends them to the outside by the wireless transmission unit.
The portable 12-lead ECG signal acquisition device according to claim 1, characterized in that:

The 10 electrodes are fabric electrodes.
The portable 12-lead ECG signal acquisition device according to claim 2, characterized in that:

The fabric electrode is processed by a chlorination process.
The portable 12-lead ECG signal acquisition device according to claim 1, characterized in that:

The right glove is made of elastic material.
The portable 12-lead ECG signal acquisition device according to claim 1, characterized in that:

Among the 10 electrodes,

The first electrode is located at the base of the thumb to measure the electrical signal of V1;

The second electrode is located at the base of the index finger close to the base of the thumb, and is used to measure the electrical signal of V2;

The third electrode is located near the intersection of the root of the middle finger and the root of the ring finger, and is used to measure the electrical signal of V3;

The fourth electrode is located at the first knuckle of the ring finger and is used to measure the electrical signal of V4;

The fifth electrode is located at the second knuckle of the ring finger and is used to measure the electrical signal of V5;

The sixth electrode is located at the third knuckle of the ring finger and is used to measure the electrical signal of V6;

The seventh electrode is located at the fingertip of the thumb to measure the electrical signal of RA;

The eighth electrode is located at the tip of the index finger to measure the electrical signal of LA;

The ninth electrode is located at the fingertip of the little finger and is used to measure the electrical signal of LL;

The tenth electrode is located at the lower right of the palm near the wrist and is used to measure the electrical signal of RL.
The portable 12-lead ECG signal acquisition device according to claim 1, characterized in that:

An interlayer is formed on the back side of the right glove; the control unit, the ECG signal acquisition unit, and the wireless transmission unit are arranged on a flexible circuit board; the flexible circuit board and the control unit and the ECG signal acquisition unit on the flexible circuit board , The wireless transmission unit is accommodated in the interlayer.
The portable 12-lead ECG signal acquisition device according to claim 1, characterized in that:

The wireless transmission unit performs wireless communication through Bluetooth, WIFI, or Zigbee.
The method of using the portable 12-lead ECG signal acquisition device according to any one of claims 1-7, characterized in that it comprises the following steps:

The portable 12-lead ECG signal acquisition device establishes a wireless connection with external terminal equipment;

The right glove worn on the user’s right hand is attached to the user’s left chest with the five fingers spread out. The center of the palm of the right glove is located in the middle of the user’s sternum, and the height is level with the heart; the thumb of the right glove extends to the upper right, Extend the index finger to the upper left, the thumb tip and the index finger tip at the same height; the middle finger and ring finger extend naturally, and the ring finger tip is close to the left front axillary line; the little finger stretches toward the lower left; making the 10 electrodes directly contact the user's skin ；

The ECG acquisition module collects the original ECG signals transmitted by the 10 electrodes, converts them into ECG data by the microcontroller, and finally transmits the ECG data to external terminal equipment through the wireless transmission unit.