CN121265080A - A wearable, wire-free, button-type Bluetooth ECG monitoring system - Google Patents

Abstract

This invention discloses a wearable, wire-free, button-type Bluetooth ECG monitoring system, applied in the field of medical electronic monitoring equipment technology. It includes a button-type ECG sensor module and a Bluetooth receiving terminal module. The button-type ECG sensor module is an integrated button-type structure, including an outer shell layer and an electrode layer located inside the outer shell layer. The electrode layer uses a flexible silver or silver chloride conductive film and has two independent acquisition points with a preset spacing. The Bluetooth receiving terminal module is a smart device with an ECG monitoring APP installed. The button-type ECG sensor module transmits ECG signals to the Bluetooth receiving terminal unit in real time via a built-in low-power Bluetooth chip. This invention achieves "instant measurement upon application, real-time monitoring, and portability," while ensuring stable ECG signal acquisition, real-time display of waveform and pulse data, and abnormal warnings.

Description

Wearable lead-wire-free button type Bluetooth electrocardiograph monitoring system

Technical Field

The invention relates to the technical field of medical electronic monitoring equipment, in particular to a wearable lead-wire-free button type Bluetooth electrocardiograph monitoring system.

Background

The existing electrocardiographic monitoring technology mainly has the following defects:

The lead wire constraint problem is that the traditional electrocardiograph monitoring equipment relies on a plurality of lead wires to connect an electrode plate with a monitor host, the lead wires are easy to wind and pull, the electrode plate falls off, and the activities of a user are limited (such as bedridden monitoring can not move freely), so that the traditional electrocardiograph monitoring equipment is not suitable for long-term or mobile scene monitoring;

the existing monitors are mostly desktop or portable (with the weight of 1-3kg generally), and are required to be independently powered, so that 'monitoring at any time and any place' cannot be realized, and the light-weight monitoring requirement of the old and the sports crowd at home is particularly difficult to meet;

The wireless scheme is imperfect, and although part of the existing wireless electrocardiograph equipment removes lead wires, the electrode plates and the receiving modules still need small connecting wires, and most of the receiving ends are special equipment (non-universal intelligent terminals), so that the problem of 'pseudo wireless' and 'insufficient portability' exists, meanwhile, the signal transmission stability is poor (the environment is easy to interfere), and the wearing comfort is low (the hard shell electrode laminating performance is poor).

Therefore, how to provide a wearable lead-wire-free button type bluetooth electrocardiograph monitoring system capable of effectively solving the defects of the existing electrocardiograph monitoring technology is a problem that needs to be solved by those skilled in the art.

Disclosure of Invention

In view of the above, the invention provides a wearable lead-wire-free button type Bluetooth electrocardiograph monitoring system, and provides a Bluetooth electrocardiograph monitoring scheme which is completely free of lead wires and based on button type sensors and general intelligent equipment, and solves the problems of portability, comfortableness and practicability in the prior art.

In order to achieve the above purpose, the present invention adopts the following technical scheme:

A wearable lead-wire-free button type Bluetooth electrocardiograph monitoring system comprises a button type electrocardiograph sensor module and a Bluetooth receiving terminal module;

The button type electrocardio sensor module is of an integrated button type structure and comprises an outer shell layer and an electrode layer positioned on the inner side of the outer shell layer, wherein the electrode layer adopts a flexible silver or silver chloride conductive film and is provided with two independent collecting points with preset intervals;

The Bluetooth receiving terminal module is an intelligent device provided with an electrocardiographic monitoring APP;

The button type electrocardiosignal module transmits electrocardiosignals to the Bluetooth receiving terminal unit in real time through a built-in low-power consumption Bluetooth chip.

Optionally, the outer shell layer is made of medical grade flexible silica gel or polyether-ether-ketone material, the surface is subjected to anti-skid treatment, one side of the outer shell is provided with an arc-shaped joint surface, the other side of the outer shell is provided with an insulating sealing cover, and the electrode layer is positioned on the inner side of the arc-shaped joint surface.

Optionally, the surface of the flexible silver or silver chloride conductive film is also covered with medical pressure-sensitive conductive adhesive.

Optionally, the button type electrocardiosignal module further comprises a signal processing unit which comprises a low-power-consumption electrocardiosignal acquisition chip and a signal analog-to-digital conversion unit, wherein the low-power-consumption electrocardiosignal acquisition chip is used for amplifying, filtering and removing power frequency interference of electrocardiosignals, and the signal analog-to-digital conversion unit is used for converting electrocardiosignals into electrocardiosignals.

Optionally, the button type electrocardio sensor module further comprises a power supply module which adopts a miniature button lithium battery and is matched with a low-power consumption power management unit based on dormancy and awakening functions.

Optionally, each interlayer of the button type electrocardio sensor module is sealed by medical epoxy resin.

Optionally, the electrocardiographic monitoring APP has the following functions:

Bluetooth pairing and connection, namely automatically searching and pairing button type electrocardio sensor modules and supporting one-to-many connection;

real-time data display, namely dynamically displaying the electrocardio waveform, synchronously calculating and displaying the pulse rate;

Data storage and tracing, namely storing electrocardiographic data according to time stamps, and supporting inquiry of historical waveforms and pulse records;

Abnormal early warning, namely alarming through sound, vibration and popup window when the heart rate exceeds a preset heart rate threshold value or the electrocardiographic waveform is abnormal;

And data export, namely supporting the exporting of the electrocardiographic data into a standard format, and sharing the electrocardiographic data to the medical terminal through a mail or a cloud disk.

Compared with the prior art, the wearable lead-wire-free button type Bluetooth electrocardiograph monitoring system has the following beneficial effects:

The portable monitor has the advantages that the lead wire is eliminated, the sensor unit is only button-sized, the weight is less than or equal to 10g, the portable monitor can be worn with people, daily activities (such as walking, working and sleeping) are not influenced, and the defect that the traditional equipment is strong in constraint feeling and incapable of mobile monitoring is overcome;

The intelligent device has no independent host, reduces the use cost and threshold, uses the existing intelligent device (mobile phone or tablet) as a receiving terminal, does not need to purchase a special monitor host additionally, greatly reduces the equipment cost, accords with the use habit of the masses, and is convenient for popularizing family and basic medical scenes;

The signal is stable, the monitoring precision is high, the flexible Ag or AgCl electrode is tightly attached to the skin, and the signal-to-noise ratio of the electrocardiographic waveform is more than or equal to 40dB and the pulse rate measurement error is less than or equal to +/-1 time/min in cooperation with the low-power consumption Bluetooth anti-interference transmission and signal filtering treatment, so that the daily health monitoring and preliminary clinical reference requirements are met;

The wearing is comfortable, the safety is high, the shell and the electrode layer are made of medical grade materials, the electrode is hyposensitised and waterproof, and can be continuously worn for 7-14 days (without frequent replacement), so that skin irritation caused by frequent sticking of the traditional electrode plate is avoided;

the system has comprehensive functions and strong practicability, supports real-time display, data storage, abnormal early warning and data export, meets the requirements of daily health management and medical data traceability, and is particularly suitable for heart rate monitoring of the elderly, electrocardiographic monitoring of sports crowd and home follow-up visit of chronic patients.

Drawings

In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings that are required to be used in the embodiments or the description of the prior art will be briefly described below, and it is obvious that the drawings in the following description are only embodiments of the present invention, and that other drawings can be obtained according to the provided drawings without inventive effort for a person skilled in the art.

Fig. 1 is a schematic diagram of a system structure provided by the present invention.

Detailed Description

The following description of the embodiments of the present invention will be made clearly and completely with reference to the accompanying drawings, in which it is apparent that the embodiments described are only some embodiments of the present invention, but not all embodiments. All other embodiments, which can be made by those skilled in the art based on the embodiments of the invention without making any inventive effort, are intended to be within the scope of the invention.

Example 1:

The embodiment 1 of the invention discloses a wearable lead-wire-free button type Bluetooth electrocardiograph monitoring system, which is shown in figure 1 and comprises a button type electrocardiograph sensor module and a Bluetooth receiving terminal module.

The button type electrocardio sensor module is of an integrated button type structure (a layered structure from top to bottom or from inside to outside, and has the diameter of 12-20mm and the thickness of 3-6 mm) and comprises an outer shell layer and an electrode layer positioned on the inner side of the outer shell layer, wherein the electrode layer adopts a flexible silver or silver chloride (Ag or AgCl) conductive film (the thickness is 50-100 mu m), the surface of the electrode layer is covered with medical pressure-sensitive conductive adhesive, and two independent acquisition points with preset intervals (the interval is 3-5mm and the acquisition requirement of single-lead electrocardio signals is met) are arranged on the surface of the electrode layer.

The outer shell layer is made of medical grade flexible silica gel or polyether ether ketone (PEEK) material, the surface of the outer shell layer is subjected to anti-skid treatment, one side of the outer shell layer is provided with an arc-shaped joint surface (adapting to the curved surface of the chest or wrist skin of a human body), and the other side of the outer shell layer is provided with an insulating sealing cover (preventing sweat or dust from invading), wherein the electrode layer is positioned at the inner side of the arc-shaped joint surface.

The button type electrocardiosignal sensor module further comprises a signal processing unit integrated in the sensor, wherein the signal processing unit comprises a low-power-consumption electrocardiosignal acquisition chip and a signal analog-to-digital conversion (ADC) unit (12-16-bit resolution, signal precision is guaranteed) and is used for amplifying, filtering and removing power frequency interference on electrocardiosignals and converting the electrocardiosignals into electrocardiosignal digital signals.

The button type electrocardio sensor module further comprises a power supply module, wherein a miniature button lithium battery (with the capacity of 50-100mAh and the working voltage of 3.0V) is adopted, and the button type electrocardio sensor module is matched with a low-power consumption power management unit (single-time charging and cruising for 7-14 days) based on dormancy and awakening functions.

All layers of the button type electrocardio sensor module are sealed by medical epoxy resin, so that the waterproof grade of IP67 is achieved (the daily washing and sweating scenes are met).

The Bluetooth receiving terminal module is an existing general intelligent device (a smart phone, a tablet computer and an Android or iOS supporting system) provided with an electrocardiographic monitoring APP.

Electrocardiogram monitoring APP has the following functions:

bluetooth pairing and connection, namely automatically searching and pairing button-type electrocardio sensor modules, and supporting one-to-many connection (2-3 sensor units can be connected simultaneously to realize multi-position electrocardio monitoring);

real-time data display, namely dynamically displaying the electrocardio waveform (sampling rate is 200-500Hz, clinical signal precision is met), synchronously calculating and displaying the pulse rate (error +/-1 time/min);

data storage and tracing, namely storing electrocardiographic data according to a time stamp (offline storage is supported, automatic continuous transmission is carried out after disconnection), and inquiring historical waveforms and pulse records (storage period is more than or equal to 30 days);

abnormality early warning, namely alarming through sound, vibration and popup window when the heart rate exceeds a preset heart rate threshold (which can be defined by users, such as 40-100 times per minute of resting heart rate of an adult) or an electrocardiographic waveform is abnormal (such as initial identification of atrial fibrillation and judgment based on abnormal R wave interval);

And data export, namely supporting the exporting of the electrocardiographic data into a standard format (such as CSV and DICOM, compatible with clinical analysis software), and sharing the electrocardiographic data to a medical terminal through a mail or a cloud disk.

The button type electrocardiosignal module transmits electrocardiosignals to a Bluetooth receiving terminal unit in real time through a built-in low-power consumption Bluetooth chip (supporting BLE5.0 and above protocols and having a transmission distance of 10-30m and strong anti-interference capability).

The system work flow:

the user attaches the button type electrocardio sensor module to the appointed position of the chest (such as the fourth intercostal of the left chest and corresponds to the single-lead electrocardio acquisition site), and the electrode layer is tightly contacted with the skin through conductive adhesive;

the button type electrocardio sensor module is automatically awakened, and an electrocardio monitoring APP of a Bluetooth receiving terminal module is searched and connected through a built-in low-power consumption Bluetooth chip;

the signal processing module acquires electrocardiosignals in real time, and transmits the electrocardiosignals to the Bluetooth receiving terminal module through the low-power Bluetooth chip after amplification, filtering, power frequency interference removal and ADC conversion;

After the electrocardiographic monitoring APP receives signals, electrocardiographic waveforms are drawn in real time, and pulse rates are calculated and displayed;

If abnormal heart rate or abnormal waveform is detected, triggering an alarm by the electrocardiograph monitoring APP;

The user can view historical data, derive reports, or share to medical personnel through the APP.

Example 2:

the embodiment 2 of the invention discloses a specific application of a wearable lead-wire-free button type Bluetooth electrocardiograph monitoring system, which comprises the following steps:

button type electrocardio sensor module unit parameter:

Size, diameter 15mm, thickness 4mm, weight 8g;

The shell is made of medical silica gel (Shore hardness is 50-60 HA), and the radian R of the joint surface is=30mm;

the electrode layer is an Ag or AgCl flexible conductive film, and the conductive adhesive is medical acrylic pressure-sensitive adhesive;

The low-power consumption electrocardiosignal acquisition chip has the functions of 1000 times gain, 0.5-100Hz bandwidth and 50 or 60Hz power frequency filtering;

The low-power consumption Bluetooth chip is BLE5.2, the transmission rate is 1Mbps, and the receiving sensitivity is-90 dBm;

The power supply module is a CR2032 button lithium battery (capacity of 225 mAh) for 10 days (monitoring for 8 hours per day);

waterproof grade IP67;

receiving terminal and APP:

A receiving terminal, namely a smart phone (Android 11.0 and above, iOS 15.0 and above);

electrocardiograph monitoring APP function:

pairing, namely opening an electrocardiographic monitoring APP and then automatically scanning the sensor, clicking a name to pair, and displaying 'connected' after successful pairing;

Display, waveform interface real-time refreshing (sampling rate 250 Hz), right side display real-time pulse rate (unit: times/min);

Alarming, namely defaulting the heart rate threshold value to 45-105 times/min, wherein after the heart rate threshold value exceeds the threshold value, the threshold value can be customized in 'setting';

Storing, namely storing waveforms according to the classification of 'days', wherein the waveforms within 30 seconds can be played back after clicking a certain time point;

export-support exporting waveform data (including pulse recordings) for a selected period of time as a CSV file, sent to the physician via a WeChat.

In the present specification, each embodiment is described in a progressive manner, and each embodiment is mainly described in a different point from other embodiments, and identical and similar parts between the embodiments are all enough to refer to each other. For the device disclosed in the embodiment, since it corresponds to the method disclosed in the embodiment, the description is relatively simple, and the relevant points refer to the description of the method section.

The previous description of the disclosed embodiments is provided to enable any person skilled in the art to make or use the present invention. Various modifications to these embodiments will be readily apparent to those skilled in the art, and the generic principles defined herein may be applied to other embodiments without departing from the spirit or scope of the invention. Thus, the present invention is not intended to be limited to the embodiments shown herein but is to be accorded the widest scope consistent with the principles and novel features disclosed herein.

Claims (7)

1. A wearable, wire-free, button-type Bluetooth ECG monitoring system, characterized in that it comprises: a button-type ECG sensor module and a Bluetooth receiver terminal module; The button-type ECG sensor module is an integrated button-type structure, including: an outer shell layer and an electrode layer located inside the outer shell layer; wherein, the electrode layer is made of flexible silver or silver chloride conductive film and has two independent acquisition points with a preset spacing; The Bluetooth receiving terminal module is a smart device with an ECG monitoring APP installed; The button-type ECG sensor module transmits ECG signals to the Bluetooth receiving terminal unit in real time via a built-in low-power Bluetooth chip. 2. The wearable wireless button-type Bluetooth ECG monitoring system according to claim 1, characterized in that the outer shell layer is made of medical-grade flexible silicone or polyetheretherketone material, the surface is treated with anti-slip treatment, and one side of the outer shell is provided with an arc-shaped contact surface, and the other side is provided with an insulating sealing cover; wherein, the electrode layer is located inside the arc-shaped contact surface. 3. The wearable wireless button-type Bluetooth ECG monitoring system according to claim 1, characterized in that the surface of the flexible silver or silver chloride conductive film is further covered with medical pressure-sensitive conductive adhesive. 4. A wearable, wire-free, button-type Bluetooth ECG monitoring system according to claim 1, characterized in that the button-type ECG sensor module further includes: a signal processing unit, including: a low-power ECG signal acquisition chip for amplifying, filtering, and removing power frequency interference from the ECG signal; and a signal analog-to-digital conversion unit for converting the ECG analog signal into an ECG digital signal. 5. A wearable, wireless, button-type Bluetooth ECG monitoring system according to claim 1, characterized in that the button-type ECG sensor module further includes: a power supply module, which adopts a miniature button lithium battery and is equipped with a low-power power management unit based on sleep and wake-up functions. 6. A wearable, wire-free, button-type Bluetooth ECG monitoring system according to claim 1, characterized in that the layers of the button-type ECG sensor module are sealed with medical-grade epoxy resin. 7. A wearable, wire-free, button-type Bluetooth ECG monitoring system according to claim 1, characterized in that the ECG monitoring APP has the following functions: Bluetooth pairing and connection: Automatically searches for and pairs with the button-type ECG sensor module, and supports one-to-many connections; Real-time data display: Dynamically displays electrocardiogram waveforms, and synchronously calculates and displays pulse rate; Data storage and traceability: ECG data is stored by timestamp, and historical waveform and pulse records can be queried. Abnormal warning: When the heart rate exceeds the preset heart rate threshold or the electrocardiogram waveform is abnormal, an alarm will be triggered by sound, vibration and pop-up window; Data export: Supports exporting ECG data to a standard format and sharing it to medical terminals via email or cloud storage.