SYSTEM AND DEVICE FOR RECORDING AND MONITORING ELECTROCARDIOGRAM (ECG)

Field of invention

This invention is related to the field of medical engineering, especially related to a system and device for recording and monitoring electrocardiogram (ECG).

Background of the invention

The cardiac electrical system plays a key role in controlling the cardiovascular system, when the said system is malfunctioning it will cause the symptom which is called“Cardiac arrhythmia” wherein these groups of symptoms are Tachyarrhythmia, Bmdyarrhythmia or conducting system disease. However, when diagnosing all types of Cardiac arrhythmia, only the Electrocardiography data of when the symptom is occurring is used for the diagnosis. Since, merely considering the symptom and checking the pulse rale are not sufficient for a diagnostic because the result is not specific enough, as a result, this method is not able to be used as a supporting data for a treatment. Even thought, efficient treatments for all types of Cardiac arrhythmia are available and some types of Cardiac arrhythmia are curable, nevertheless, it needs to be taken into consideration that all types of Cardiac arrhythmia are life threatening and the urgency of treatment varies. Therefore, monitoring the electrocardiogram data of the patient for at least 3 to 6.8 days is needed in order to diagnose and treat Cardiac arrhythmia because a majori ty of Cardiac arrhythmia could be detected in a short span of time. Therefore, the key factor of the diagnoses and the treatment of the symptom relies upon the monitoring capacity of the electrocardiogram device.

The electrocardiogram device existed in Thailand could be categorized into three types, namely the event ECG recorder, the ECG Holler monitor and tire Telemetry ECG.

1 ) the event ECG recorder is portable and it could be use with a Tran-telephonic system but cannot be used for nan-symptomatic diseases, cannot record the data continuously, not able to track the Electrocardiography result data and the user must have the device at close range at all times.

2) the ECG Holter monitor could record the data continuously over 72 hours which is sufficient enough to diagnose the disease and it could also track the Electrocardiography result data. However, when it is removed from the patient, the patient would not be able to re-attach it back by themselves. Therefore, this type of ECG is not user friendly for patient who needs to have the device attached for a long period of time. Moreover, this type of ECG cannot automatically send the Electrocardiography data back to the hospital. The patient therefore needs to bring the device bade to the hospital in order to retrieve the data form the device, which then it will consume a lot of lime to check and analyze the data. The main problem is that the Electrocardiography data of the time period before the device had been installed and the lime period after the device is detached from the patient are not detectable. The Electrocardiography data could be retrieved is only when the device has been returned to the hospital in order to process the ECO data. The mentioned disadvantages above, it is time consuming and costly. Furthermore, in a worst-case scenario, when the patient develops life-threatening Cardiac arrhythmia episode, they would not receive any help within time which this could resulted in the fatality of the patient.

3 ) the Telemetry ECO is capable of continuously recording the Electrocardiography data and could be used for a long period of time. This type of ECG works by transmitting related data to be recorded at the ECG monitoring center in real time. However, this type of ECG is expensive and requires the observation and the evaluation of the Electrocardiography data by a specialized nurse and a skilled person. Additionally, it uses radio frequency to transmit data which could be transmitted within a limited distance.

With merely the ECG data, it is not sufficient to properly treat a patient. Therefore, it requires a highly experienced and specialized team of doctors and nurses to perform an advance analysis on the Electrocardiography data to be used along with the treatment. Fuithennore, the monitoring of the ECG for a long period of time requires tremendous time and labor. Also, in emergency cases which need doctor consultancy, transmitting of fTectrocardiogmphy data to a specialized doctor in time, needed to be taken in consideration. Further, there are also the lack of personnel, the training sessions for the doctors and nurses is time consuming, the lack of personnel who is interested in this field of work or the limited number of specialized doctors which could perform the data analysis and finding the appropriate treatment

Presently, there are rapid developments on medical technology and tire communication technology. Especially in Thailand, where the prices of BCG-related devices and equipment prices has decrease from the past, which resulting in that majority of people can gain access to this technology. Additionally, when tire two mentioned technologies have been improvised to be used in combination as seen in many countries, it leads to the production of new ECG devices, for example, the Ambulatory ECG patch device which can both work individually or works along with the central ECG monitoring system via the internet network, these creating huge benefits to the patients and caretakers. However, the existing ECG devices and systems still have some defects. For instance, the event ECG recorder or the Loop event ECG recorder needs to send BCG data via the Tran-telephonic system, or the ECG Hotter monitor device which needs to be brought back to the hospital in order to retrieve ECG data, or the Telemetry ECG which has to be operated by a skilled persons to observe and interpret the ECG data and send the data only via radio wave restricted use solely in-hospital use. Furthermore, the mentioned devices are quite too expensive for people in general to access to. As a result, there is a limited number of users and the doctor cannot appropriately take advantage of the device for the highest benefits. Therefore, service charge rate of ECG devices of each hospital is different and is it too high for the patient to get access to the treatment and there is a lack of after-sale services and also the lack of quality developments of the device.

Patent searches from the Thai’s patent database related to system and apparatus for recording and monitoring electrocardiogram (ECG) which can communicate remotely or via wireless network. Related invention founded are as the followings.

Thai petty patent application No. 1603000137, Invention Title “Wireless electrocardiogram measuring device recorded in cloud computing system” which disclosed the device comprising skin measuring ECG device and transmitting a signal to a signal expanding unit and filtering unit in order to transmit the signal to an ECG signal transmitting part respectively, via a Bluetooth wireless communicating system. The said signal was transmitted to a final signal frequency filtering unit so as to choose frequency required, subsequently, the filtered signal was transmitted to a processing unit in a computer in order to process ECG signal compatible to a recorded standard referenced signal. The processed signal was displayed its compatible result in a computer display screen. Furthermore, the ECG data was transmitted and recorded on a cloud computing system, wherein the data result analyzed could be retrieved via social media. Additionally, the device according to this invention further comprised a power supply for each part of the device. However, there was shortcoming that this device could not record BCG data during its functioning time. Consequently, when wireless communication network was not working, some unrecorded ECG data would be lost.

Khai patent application No. 090 1 00273 1 , Invention title“System for monitoring and analyzing electrocardiogram via telecommunication network” which disclosed the system comprising three main parts namely a patient source system, a caretaker terminal system, and a server. The patient source system connected to the caretaker terminal system in order to perform data communication between the two system, via wired communication network, such as Transmission Control Protocol/lntemet Protocol (TCP/IP), or IAN network. Furthermore, the said data communication was performed via wireless communication network, such as, Wi-fi, Wi- Max, or WAN. Additionally, the last part of the system according to this invention was the server connecting to a communication network which contain the patient’s general information and medical history information for the purpose of diagnosing the patient’s symptoms when needed. The said invention, however, solely descripted the operating system but not descripting the operation processes of the device used.

Thai patent application No. 0801004890, Invention title “Method for classifying Electrocardiogram (BCG) signal abnormality” which disclosed a system for classifying ECO signal abnormality by using the changed signal property. This system was used as a tool for classifying abnormality of BCG signal by a signal processing technique, which had less complicated calculation method, used small numbers of training data, but yielded higher accurate result and higher reliable result than those of Support Vector Machine: SVM method and Neural Network: NN method. However, changing parameters’ values within the system disclosed only the processing method but not disclosing the system or the device used.

From the information above, the existed prior arts have some defects that working features of the devices are still separated procedures, such as, it only measuring the ECG when the symptom is occurring, or only performing continuous ECG measuring, or only performing remote continuous ECG measuring. In other words, the prior art inventions ECG data quality check before performing measurement, and it cannot record the ECG data into the device. Iherefore, when there is no connection between the device and a recording system, the ECG data may be lost or incomplete. Additionally, the device needs installing and performing solely by a specialist or a skilled healthcare provider.

The system and device for recording and monitoring electrocardiogram (ECG) according to this invention is configured to monitor ECG dining symptom showing, perform continuous ECG monitoring, and perform remote continuous ECG monitoring in one time, litis invention is able to record ECG data for a long period of time, and rapidly record the said data in the case that the patient has a symptom in a short period of time. Furthermore, this invention is capable of browsing symptom occurring time data, and further comprises a temporary memory unit helping record ECG data in a given period of time. Therefore, the problem of ECG data loss is diminished by that the system is configured to process diagnostic result analysis and record the analysis in cloud computing system. As a result symptom evaluation is able to be made faster by the healthcare provider. Additionally, with ECG signal quality display function that is performed before recording the ECG data, the patient or patient’s family is able to install the ECG device by themselves. Consequently, the device becomes comfortable to use, and is configured to transmit ECG signal via wireless internet network, as a result, there is no distance limit to transmit the ECG data. Furthermore, this system is able to work with a central management system so that there is increasing effectiveness of an ECG data gathering service, and it is able to make a disbursement report. Moreover, the system is accessed only by skilled doctors and nurses who gained permission to the ECO data, as a result, this system has high information security.

Summary of the invention

The system and device for recording and monitoring electrocardiogram (ECG) according to this invention comprising: an electrocardiogram (ECG) recording and monitoring part which contains at least an electrode configured to transmit the ECG signal to a sensor; a signal management unit; a processing unit; and a signal transmitting unit connected via the internet network to a server, a displaying unit, and a cloud computing system. The system and device further comprise: a temporary memory unit for recording temporaiy ECG signal within a set time interval. After that the said ECG signal data is processed and diagnosed, as well as displayed or recorded. Additionally, this system and device limits the access to the ECG database for only the authorized healthcare providers via a communication device in order to use the data for symptom diagnosing or to retrieve the historical data.

The electrocardiogram (ECG) recording and monitoring device comprises an electrocardiogram (ECG) recording and monitoring part comprising: at least two electrodes connecting to the sensor which plays a role in monitoring the ECG signal; the signal management unit; the signal transmitting unit; the signal processing unit; and a power supply which connects to the server and/or the displaying unit and/or the cloud computing system or combination thereof The previous connection is performed via an internet system or wireless network which contains a temporary memory unit so as to record temporary data transmitted from the processing unit within the set time interval .

The objective of this invention is to create a system and device for recording and monitoring EiCG signal which can performs many necessary functions with only one device. The invention is configured to effectively gather ECG data, continuously record the ECG data, rapidly record the ECG data in the case that the symptom is shown in a short span of time and is able to browse the ECG data that were recorded during the occurring of the symptom. Additionally, adding higher security, preventing the loss, adding more accuracy symptom diagnosis for the ECG data by connecting with the cloud computing system. Furthermore, this invention cost much lower than the imported one which allows the patient to easily gain access to symptom monitoring and foe symptom treatment, also the patient can be continuously and promptly followed-up and diagnosed by healthcare providers. Moreover, this invention helps reduce foe number of healthcare providers needed for follow-up the patient’s symptom, reduce the overcrowded number of patients waiting for service in the hospital, reduce the transportation obstacle and promote a better health care system in the national and international scales in the foreseeable future. Brief description of the drawings

FIG. 1 illustrates one example of a system and device for recording and monitoring electrocardiogram (EGG) according to the invention.

FIG. 2 illustrates one example of a method for recording and monitoring electrocardiogram (EGG) according to the invention.

FIG. 3 illustrates one example of a chart of the EGG recording and monitoring system according to this invention.

Detailed description of the invention

The system and device for recording and monitoring electrocardiogram (EGG) is a system configured to monitor the EGG data from the patient developing Cardiac arrhythmia by installing the EGG recording and monitoring device on the patient’s chest and starting the device system on. Subsequently, the system will start monitoring, gathering and recording the EGG data then the said data will be processed, displayed, and recorded. Furthermore, the EGG data will be diagnosed by healthcare providers to follow-up and treat the patients according to their results. More importantly, the recorded data is able to be retrieved by the persons permitted to access the data or an authorized person.

According to FIG. 1 illustrating one example of a system and device for recording and monitoring electrocardiogram (EGG) according to this invention, the system for recording and monitoring EGG comprise: an electrocardiogram ( EGG) recording and monitoring part 1 configured to record and monitor EGG data from the patient 2, then to manage the said data and to perform a first signal processing before transmitting the said signal to be processed on a server 3 and/or a displaying unit 4 and/or a cloud computing system 5 or combination thereof. For the most appropriate performance, the EGG recording and monitoring part l processes the first EGG signal, transmit the signal to the cloud computing system 5 to be processed into a diagnosed EGG data and subsequently, it will record the EGG data and transmit it to the server 3 or the displaying unit 4 in order that the authorized person can gain access to the EGG data and use the data to evaluate the patient’s EGG for the future treatment of each patient. Furthermore, the said EGG recording and monitoring part 1 comprises: at least an electrode placed on the patient’s 2 chest for measuring the EGG data signal 101 of the patient 2 and transmitting the signal to a sensor which will receive the signal from the body in forms of EGG signal, tire EGG device further comprises: a signal management unit configured to amplify the EGG signal, filter out other non- related signals and then converting the analog signal into digital signal; a processing unit configured to process the managed EGG signal; a temporary memory unit configured to record the signal received from the processing unit above within the set time interval before transmitting the ECG signal to other parts of tire system. Moreover, the ECG device additionally comprises a signal receiving- transmitting unit configured to receive the signal from the processing unit and transmit the said signal to the server 3 or the displaying unit 4 or the cloud computing system 5 via the internet network.

The device tor recording and monitoring ECG according to the FIG. 1 is configured to be in a box shape with a display screen within installing tire ECG recording and monitoring part 1 wherein it comprising:

at least two electrodes for measuring the electrocardiogram (ECG) data, preferably a snap electrode which is user-friendly, easily replaceable when needed, easily remove or re-attached by a general user and is configured to further connects to;

a sensor configured to receive a signal from the body in forms of an ECG signal;

a signal managing unit configured to amplify the ECG signal and filter out other non- related signals and then convert the analog signal into digital signal respectively;

a signal processing unit configured to process the managed ECG signal transmitted form the signal managing unit;

a temporary memory unit configured to record the signal received from the signal processing unit within a determined time, and then transmit the signal to other data receiving parts of the device;

a signal receiving-transmitting unit, preferably a communication device which transmits data via wireless network, configured to receive the signal from the signal processing unit and transmit the signal to the server 3 and/or tire displaying unit 4 and/or the cloud computing system 5 or combination thereof through internet or wireless network, preferably the signal receiving- transmitting unit transmits the signal to the cloud computing system 5 which is configured to process and record the signal to diagnosed ECG data, then sent the data to the server 3 or the displaying unit 4 , wherein the server 3 plays a role in recording, gathering, and displaying data transmitted from the ECG recording and monitoring device which is accessed only by a user 6 permitted to gain access and browse the said data via a permitted communication device and wherein the displaying unit 4 plays a part in the server 3, but it is in forms of a portable communication device which is able to connect to tire data via a wireless network such as a mobile phone or a tablet, is able to transmit current location of the patient 2 to medical personals and healthcare providers for considering appropriate help in case of urgency;

a power supply which is a power source for the device, configured to be re-charged through wire or wireless charging method; and additionally, a signalling apparatus for displaying working status of the device, for example, the device now is in a working mode or there is alert signal when the power supply needs charging, wherein the said apparatus signal is able to be chosen from a sound, light or vibration signal.

According to FIG. 2 illustrating one example of a method for recording and monitoring electrocardiogram (ECG) according to the invention, the method respectively comprises:

a device installing process 1 1 , the device is configured to be installed on one side of the chest of a patient 2, then starting the device system by manually pressing a start button of the device or opening an automatic mode through an operating system of the displaying unit of the communication device, such as a mobile phone or a tablet;

the displaying of the ECG signal quality 12 by controlling a display screen which contains the ECG recording and monitoring part 1 , showing the ECG signal quality of the patient 2 before performing the method of the device, wherein supposing the quality of ECG signal reaches the criteria (Yes) which is clear and consistent, the device is configured to measure the ECG signal 21 , on the contrary, if the signal does not reaches the criteria (No), the user needs to re-installing or re-locating the device, wherein the user or installer ought to adjust the ECG signal quality to reach the criteria or Yes mode so that the user is able to measure the ECG signal 21 ;

receiving the signal 13 when the user starts measuring ECG data 101 by the electrode, wherein the data is transmitted to the sensor for receiving the measured signal in forms of ECG signal which when the sensor is working, a signaling apparatus that displays working status of the device will indicate a signal showing that the apparatus is working, such as a light signal; amplifying the signal 14 wherein the ECG data 1 0 1 received from the sensor will be transmitted to the signal management unit so as to be amplified by increasing the amplitude or tiie voltage of the signal for the purpose of a signal processing;

filtering the signal 1 5 wherein after the ECG data is amplified 14, the said data is configured to be filtered 15 in order to filter out other signals off, then converted the ECG signal from analog signal into digital signal;

processing the signal 16 by the signal processing unit configured to process the managed ECG data 1 01 wherein the said data is processed 16 and separated into two types, which are normal or abnormal ECG, so as to be a basis for making a decision before sending it to the server 3 and/or the displaying unit 4 and/or the cloud computing system 5 or combination thereof; receiving the signal 17 by the signal transmitting unit wherein the said unit is configured to receive the ECG data signal 101 processed 16; transmitting the signal 1 8 by the signal transmitting unit wherein the said unit is configured to transmit the ECG signal 101 to the server 3 and/or the displaying unit 4 and/or the cloud computing system 5 or combination thereof via the internet network or the wireless network which the user is able to determine the time for retrieving the said data, wherein the signal transmitting 1 8 is configured to perform the Loop and Event recording and/or the Holler mode recording or combination thereof at the same time , preferably that the signal is transmitted 18 to the cloud computing system 5 in order to be processed the diagnosed ECG data, then the temporary data is recorded 20 and transmitted to the server 3 or the displaying unit 4; and

displaying data 1 9 wherein the server 3 or the displaying unit 4 is configured to display the data 19 with Loop and Event recording and/or real time monitoring and/or record the data to be browse later or combination thereof, wherein the data is accessed by an authorized user 6 permitted to gain access, or to display data 19 together with transmitting the signal 1 8 to the server 3 and/or the displaying unit 4 and/or the cloud computing unit 5 or combination thereof.

When the user needs to restart the ECG system, the said user may enter into a device installing process 1 1 and test the installation process by observing signal quality display 1 2 before starting re-measuring the ECG signal 2 1 again. Additionally, the ECG system according to this invention further comprises recording temporary

signal 22 , which the ECG data 1 01 processed signal 1 6 by the signal processing unit and transmitted the temporary signal 22 to the temporary memory unit, is performed within the determined time which helps the user follow-up the sufficient related data to diagnose the ECG- related diseases. More importantly, in case, the ECG device according to this invention loses the connection with the cloud computing system 5 or the server 3 or when the power supply is flat, the ECG data is still in the temporary memory unit.

According to FIG. 3 illustrating one example of a chart of the ECG recording and monitoring system according to this invention, the patient 2 would have the device installed 1 1 in order to record and monitor the ECG signal, which is in a box shape with a display screen installed the ECG recording and monitoring part 1 within comprising: at least the two electrodes; the sensor; the signal management unit; the signal processing unit; the temporary memory unit; the signal receiving- transmitting unit and the power supply on one side of the chest of the patient 2. After the device installing procedure 11 , the nex t procedure of the method is to display ECG signal quality 1 2 by measuring the ECG signal 21 with the electrodes, when the ECG signal quality complies with the criteria (Yes) , the signal data would be transmitted to the sensor for receiving the signal 1 3 in forms of ECG signal. Then, the ECG signal received is amplified 14, filter 1 5 and firstly processed 1 6. Subsequently, the processed signal data would be transmitted to the signal receiving-transmitting unit, wherein when it receives the signal data 17 wherein the transmitting unit is able to be chosen between the two choices that whether the user would like to record the temporaiy signal 22 on the temporary memory unit or transmit the signal 18 to the server 3 and/or the displaying unit 4 and/or the cloud computing system 5 or combination thereof via the internet network or the wireless network. Preferably there is transmitting the signal 18 to the cloud computing system 5 in order to process the ECG data 102 to the diagnosed ECG data 31 then the temporary data is recorded 20 and transmitted to tire server 3 or tire displaying unit 4 wherein the transmitted ECG data 101 is encrypted 23 before being transmitted. Therefore, the user 6 is able to gain access to the ECG data only when he is permitted. Additionally, tire ECG signal data 1 01 is configured to be decoded 24 and then being displayed 19. Furthermore, the user is able to record the ECG data 20 on the server 3 and/or the displaying unit 4 and/or the cloud computing system 5 or combination thereof.

Moreover, the user 6 is capable of accessing and diagnosing the ECG data via a communication device when it is connected to the internet or the wireless network even when they are not present at the same location as the patient 2 used to evaluate and follow-up the patient’s symptoms though the user 6 is not facing with the patient 2 in the same place by storing the ECG data in the server 3 and/or the displaying unit 4 and/or the cloud computing system 5 or combination thereof. Consequently, the user 6 is able to browses the data later 32. Furthermore, in the case that the user 6 needs to re-diagnose the ECG data 101 in order to follow-up the symptoms of the patient 2 , he is able to choose to re-monitor the data 33 by installing the ECG recording and monitoring device on the patient’s 2 chest and restart the whole process.

Any modification of this invention may be clearly understood and performed by those experts with skills in the related arts or related fields. This may be subjected to the scope and intent of this present invention as described in the claims attached.

lire best method of invention is as described in detailed description of the invention.