KR20240067657A - Real-time neonatal heart-rate(ECG) measurement system for initial care immediately after birth - Google Patents

Abstract

The present invention relates to a newborn heart rate measurement device that allows accurate heart rate measurement in a short period of time upon birth by calculating the heart rate using electrocardiogram signals measured through electrodes on the chest or back of the newborn immediately after birth. Specifically, the electrodes are made of biocompatible materials. It is manufactured to safely extract electrocardiogram signals without causing skin allergies in newborns, and is connected to a personal terminal (e.g. PC, tablet, smartphone, etc.) or medical information system through a control device connected to the communication unit to monitor the health status of the newborn immediately after birth. This is about a newborn heart rate measuring device that can provide real-time electrocardiogram and heart rate data to medical staff.

Description

Real-time neonatal heart-rate (ECG) measurement system for initial care immediately after birth}

The present invention is a non-conductive electrocardiogram measurement device that can be applied to the body (chest, etc.) of a newborn. It measures the electrocardiogram of a newborn immediately after birth through a capacitive ultra-thin electrocardiogram measurement electrode coated with a biocompatible material that is harmless to the human body and is based on the electrocardiogram. It relates to a real-time newborn heart rate (electrocardiogram) measurement system and method that can perform newborn treatment and resuscitation based on accurate heart rate.

Unlike children and adults, newborns are in a physiologically unstable state as they transition from intrauterine life to extrauterine life. Therefore, fetal distress may occur in a fetus before and during the birth process, or fetal asphyxia (a state without a pulse) may occur in a newborn after birth, which is caused by a lack of oxygen supplied to biological cells and hypoxia in which carbon dioxide gas is not smoothly removed. It causes hypoxia, acidosis, and hypercarbia. Therefore, when a newborn has breathing or heart-related problems immediately after birth, the doctor in charge measures the newborn's heart rate to quickly assess the newborn's health status in order to take quick action. The most important element of the examination immediately after birth is.

Conventionally, the heart rate of a newborn is usually measured by placing a finger on the carotid artery for 6 seconds and then converting it into a heart rate value in minutes. However, this has the disadvantage that errors in measurement values may occur depending on the skill level of the doctor in charge, and the measurement time may be prolonged. In particular, extending the measurement time during the delivery process can lead to additional risks in urgent situations where every minute and every second counts.

Therefore, in the present invention, in order to measure the heart rate of a newborn immediately after birth, an electrocardiogram measurement electrode is manufactured from a biocompatible material, and the electrode is attached to the newborn's body to measure the newborn's electrocardiogram to calculate an accurate heart rate in a short time, using Bluetooth, It includes monitoring devices using mobile apps and devices that transmit to the medical information system using wireless communication modules such as WIFI.

Republic of Korea Patent Publication 10-2012-0122148 (November 7, 2012) Republic of Korea Patent Publication 10-2021-0058272 (May 24, 2021)

The purpose of the present invention is to improve the problems in the prior art. By calculating the heart rate using the electrocardiogram measured through electrocardiogram measurement electrodes on the chest or back of the newborn immediately after birth, accurate heart rate measurement can be achieved in a short time at the time of birth. The goal is to provide a neonatal heart rate measurement method and heart rate measurement system that allows medical staff to use the system easily and manage the data efficiently by transmitting the measurement data to the medical database using a control device connected to the communication unit.

Specifically, the material of the electrode is measured using a material that does not cause skin rashes or allergies in newborns, and by providing a newborn heart rate measurement device in a safe and biocompatible environment, newborn care after birth is possible through a mobile app or a separate monitor. The purpose is to display and proceed accurately and effectively.

The newborn heart rate measurement method and system is a system that provides heart rate by measuring the electrocardiogram of a newborn immediately after birth. Biocompatible electrocardiogram measurement electrodes (100) capable of measuring the electrocardiogram are placed inside a newborn swaddle or on a newborn crib (cradle). It consists of a control unit 300 that processes the electrocardiogram signal measured from the newborn and calculates the heart rate, and a communication unit 400 that can transmit the electrocardiogram data and heart rate to a monitoring device (e.g. PC, smartphone, tablet) and medical information system. It is composed.

The present invention attaches electrocardiogram measurement electrodes made of biocompatible materials to a newborn swaddle or newborn bed, with a structure that facilitates close contact and fixation of the electrodes to the skin, without the risk of skin rash or allergy immediately after birth. Accurate heart rate measurement is possible in a short period of time, which has the effect of reducing measurement errors and measurement delays in assessing the health status of newborns, helping the doctor in charge make an accurate diagnosis and enabling quick action. In addition, when measuring a newborn's electrocardiogram, the electrocardiogram and heart rate data are automatically transmitted to the monitoring device and medical information system through a wireless communication module, making it easier for medical institutions to manage integrated data, enabling remote medical treatment and increased convenience for medical staff and mothers and guardians. This has the effect of increasing satisfaction with medical services as the newborn's health status can be objectively confirmed through electrocardiogram and heart rate.

1 is a diagram of a measuring device equipped with electrocardiogram measuring electrodes according to the present invention.
Figure 2 is a connection diagram of the heart rate calculation device and measurement device according to the present invention.
Figure 3 is a signal processing block diagram of the present invention.
Figure 4 is a diagram illustrating the expected medical application of the present invention.
Figure 5 is a flow chart of the Apgar model application algorithm of the present invention.

Hereinafter, preferred embodiments of the present invention will be described in detail with reference to the accompanying drawings, but the examples are provided for clear understanding of the present invention and the present invention is not limited thereto.

The newborn heart rate measurement method and system includes a biosignal measurement electrode (or sensor unit, 100) for measuring the electrocardiogram of a newborn immediately after birth, and a fixing device or fixture for smoothly fixing the electrode 100 in close contact with the newborn's skin. Support device 200, a signal processing unit 300 that is connected to the electrodes and receives the electrocardiogram signal and calculates the heart rate through amplification, filtering, and A/D conversion, and transmits the electrocardiogram signal and heart rate data to the medical information system and external It consists of a communication unit 400 capable of wired/wireless communication with a monitoring device (smart phone, tablet, PC, etc.) and a power supply unit 500 for driving the system, and the main body signal processing unit 300 is based on the measured ECG signal. It includes a filter to remove external noise and firmware to calculate heart rate. The neonatal heart rate measurement system includes a bio-signal measurement electrode (sensor unit, 100) in consideration of the safety of the subject who may be sensitive to even a small weight. A form of connecting the PCB board body (1000) that calculates the heart rate is proposed separately through a wire (power, communication line, etc.), but the PCB that calculates the heart rate is connected to the electrode fixing device (200) that includes the bio-signal measurement electrode (100). A direct connection method can be used by attaching the board body 1000, and various wearable devices that can be worn on the upper body (bodysuit, innerwear, inner wrap, outer wrap, etc.) can be used as a fixing device.

Figure 1 is an electrocardiogram measurement system of the present invention. At the time of birth, a newborn instinctively moves many limbs and makes various movements such as skin cleaning and foreign matter removal by nursing personnel, so various types of fixation devices 200, including a band type, are used to secure the skin. The pressure on the subject was reduced by adopting a natural adhesive method that adheres the electrodes closely and does not use adhesives, and the electrocardiogram measurement electrode 100 is made of stainless steel, copper, etc. to measure newborns whose skin is more sensitive than that of adults. This ultra-thin electrode is coated with biocompatible materials (e.g. Silicon Dioxide, Titanium Dioxide, cotton, Multi Layer Dielectric material, etc.) on a metal electrode, improving biocompatibility and skin adhesion. In addition, by measuring the electrocardiogram using the capacitive coupling method, the electrocardiogram signal can be measured even if foreign substances exist outside the newborn's body. By calculating the heart rate within a short period of time and providing it to medical staff, quick measures such as newborn resuscitation are possible in the event of an emergency (neonatal asphyxia, etc.). possible.

The sensor unit 100 shown in FIG. 2 represents the inside of the biosignal sensor unit and is a device that controls and processes the electrocardiogram signal obtained by the measuring electrode 100. It digitizes the measured signal from analog and transmits it to the communication unit. If necessary, the electrocardiogram obtained through signal processing can be calculated as a pulse, and other additional biometric data, such as temperature and blood pressure, can be calculated. The biosignals measured as above can be analyzed complexly to determine the correlation with various diseases. can be observed and diagnosed.

It also shows a signal processing unit 300 that has the function of controlling the operation of other connected devices, such as communication, power, and additional external devices. In addition, the measured electrocardiogram can be stored in a separate storage device (internal memory, storage space of an external terminal), through which the heart rate can be calculated and provided to medical staff in case of very fast or slow heart rate or abnormal electrocardiogram. It can help identify heart defects, etc. The calculated or acquired data is connected to the mobile device or terminal through the communication unit 400. Communication methods can be used, including those that connect directly to the main body and connect to a terminal via serial, as well as personal and ubiquitous wireless communication methods such as Bluetooth, Wi-Fi, ZigBee, and Z-wave. There is a power supply unit 500 for the electrical operation of the device, and the internal power of this device can use both fixed and rechargeable batteries. The batteries used include alkaline batteries, manganese batteries, carbon-zinc batteries, and sodium sulfur batteries. It can include all batteries that can be used as batteries, such as batteries, lead acid batteries, nickel cadmium batteries, nickel hydride batteries, lithium ion batteries, and lithium polymer batteries.

In addition, the measuring device of the present invention can be connected to the hospital server through wireless communication and is automatically transmitted and stored in the medical information system to provide real-time data and previously stored data to medical staff, including nursing personnel, and not only during the birth process. It can also be used to check changes in the health status of newborns who need care and treatment in the neonatal intensive care unit, such as premature babies and low birth weight babies, after birth.

In addition, this measuring device is equipped with a charging terminal (e.g. C type USB) that can charge the power, so that it can be charged and used when discharged, and the heart rate measured and stored in the server is measured and stored in the server as well as other biological signals (respiration, body temperature, etc.). Apgar scores can be linked using complexly analyzed data by combining sensors, and the newborn's 1-minute Apgar score and 5-minute Apgar score can be compared to the number of neonatal resuscitations and body temperature upon hospitalization to study the effectiveness of medical treatment. can help

The Apgar score is a scoring system created to quickly evaluate the health status of a newborn immediately after birth. Apgar is used in obstetrics and gynecology to determine how anesthesia affects the newborn during delivery. Depending on the item, a minimum of 0 points and a maximum of 2 points are given to each item, and these scores are added together to evaluate the condition. That is, the total Apgar score ranges from 0 to 10. In order to easily memorize the five items, in English-speaking countries, APGAR is sometimes explained as an abbreviation for Appearance, Pulse, Grimace, Activity, and Respiration.

Figure 3 is a diagram illustrating the system operated by connecting these systems. It includes ECG electrodes for acquiring ECG signals, a signal processing unit for processing the acquired signal, a communication unit capable of wired and wireless communication, and a medical staff can view the results processed through communication. It represents a medical information system that can store and manage data obtained through terminal and communication.

Figure 4 is a diagram showing an application of a mobile terminal or display device that allows medical staff to check or judge data in real time. The app includes a time display unit 610 showing the time elapsed since birth, a display unit 620 showing the real-time pulse obtained by electrocardiogram measurement, a birth reset button 630 indicating the start of monitoring the newborn's condition, and medical procedures performed after the birth of the newborn. It is divided into a control window 640 that can visualize. The control window 640 displays the progress of medical treatment, from initial treatment to massage, which can be performed automatically or step by step according to changes in the newborn's situation. App display or action buttons can be added or deleted as needed.

Figure 5 is a flowchart for newborn care performed after the birth of a newborn. When medical treatment occurs according to the flowchart and necessary matters arise, this is displayed in the form of a warning or notification through the application.

When explaining the progress according to the flowchart of FIG. 5 through an example, when a newborn is born, it is immediately wiped warm for initial treatment, then stimulation and suction are performed (step 1), and then in a situation where the birth is reset, the newborn is placed in a holding device ( 200), the newborn's electrocardiogram and pulse are automatically measured and displayed on the display unit 620, which shows the real-time pulse obtained by measuring the electrocardiogram, when the newborn is wrapped in a swaddle or laid on the bed. In this case, oxygen treatment (step 2) is performed using positive pressure ventilation for about 30 seconds. At this time, if the newborn's heart rate exceeds 100 beats per minute, care is performed in the neonatal room after airway management and secretions are removed while maintaining warmth and body temperature as normal. However, if the newborn's heart rate is less than 100 beats per minute, the newborn must wear a mask well. After adjusting and confirming the posture to secure the airway, oxygen treatment (stage 3) is performed using positive pressure ventilation with a mask for about 30 seconds with oxygen and an appropriate level of pressure. After oxygen treatment, the heart rate measured again is checked to determine the heart rate. If the heart rate exceeds 100 beats per minute, management is performed in the neonatal room. If the newborn's heart rate is less than 100 beats per minute, repeat the above 3 steps (step 4). If the heart rate is still less than 100 beats per minute even after step 4, open the mouth and With suction, the pressure is increased and oxygen treatment is performed again for about 30 seconds using positive pressure ventilation (step 5). If the heart rate measured at this time is more than 100 beats per minute, the patient is transferred to the neonatal room for management. If the heart rate is less than 100 beats per minute, positive pressure ventilation is performed. You can proceed further (step 6). In addition, the above process may be repeated depending on the condition of the newborn, and in some cases, the above steps may be omitted, especially steps 4 and 6, depending on the medical staff's judgment.

As described above, even though steps 1 to 6 have been performed according to the flowchart shown in FIG. 5, if the heart rate is less than 100 beats per minute, positive pressure ventilation is performed for about 30 seconds after tracheal intubation (step 7), and the measured heart rate is more than 100 beats per minute. If the heart rate is less than 100 beats per minute, three cardiac massages and one positive pressure ventilation for about 60 seconds are performed (step 8). If the heart rate is not higher than 60 beats per minute, three cardiac massages and positive pressure ventilation are performed. In addition to administering epinephrine once, administer epinephrine (Epinephrine 1:10000 (0.1ml/kg)) for about 3 minutes (step 9). After administering the epinephrine, perform heart massage 3 times for about 60 seconds and positive pressure ventilation 1 at step 8. A meeting can be held. If the heart rate is less than 60 beats per minute despite the above procedures, three cardiac massages and one positive pressure ventilation for about 60 seconds are repeated. If the number of repetitions exceeds three, three cardiac massages and one positive pressure ventilation are performed. In addition, step 9 of administering epinephrine (Epinephrine 1:10000 (0.1ml/kg)) for about 3 minutes is performed as shown in the flow chart shown in FIG. 5.

If the number of repetitions exceeds 9 times in total during the above process, no more repetitions are performed, and separate medical treatment for the newborn must be performed with a warning in red on the app or monitor (alarm sound, etc.), such as the red sign in positive pressure ventilation. In addition, if the heart rate is over 60 beats, the principle is to end with a procedure such as “Supply high-concentration oxygen and transfer to the neonatal intensive care unit for treatment,” but various procedures can be set.

The electrocardiogram measurement system not only allows nursing staff to easily and automatically measure the newborn's electrocardiogram by placing the newborn on a fixed device (swaddle, bed, etc.), but also uses separate electrocardiogram measurement electrodes, which are individually needed for newborns immediately after birth. It can be made available for use.

100: ECG signal measurement electrode (sensor unit)
200: Measuring electrode fixture (fixer)
300: signal processing unit
400: Department of Communications
500: power unit
600: Newborn condition monitoring application
610: Neonatal action time display unit
620: Pulse display unit
630: Function start button
640: Control window according to newborn measures
1000: PCB board (system body)

Claims (14)

In a system for measuring vital signs of a newborn,
A bio-signal sensing unit 100 capable of measuring bio-signals; and
A fixing mechanism (200) fixed so that the bio-signal sensor unit (100) can be brought into close contact with the skin;
It consists of a PCB board 1000 including a signal processing unit 300 that amplifies the biosignal received from the biosignal sensing unit 100 and calculates the heart rate; and a communication unit 500 capable of transmitting the biosignal to an external device. A real-time neonatal heart rate measurement system characterized by In claim 1,
The heart rate measurement system is a real-time newborn heart rate measurement system characterized in that it includes electrodes capable of measuring one or more biological signals. In claim 1,
The electrocardiogram measurement system is a real-time newborn heart rate measurement system, characterized in that the bio-signal sensing unit 100 and the PCB board 1000 can be separated from the fixing device 200. In claim 1,
A real-time newborn heart rate measurement system, characterized in that the electrocardiogram and heart rate data measured from the bio-signal sensing unit 100 can be transmitted to an external device for storage and analysis. The real-time newborn heart rate measurement system according to claim 1, wherein the electrocardiogram and heart rate data measured from the bio-signal sensing unit 100 can be linked with a medical information system. In claim 1,
The bio-signal sensing unit 100 is a real-time newborn heart rate measurement system characterized by analyzing the measured bio-signals by adding sensors for measuring bio-signals including blood pressure, electrocardiogram, and body temperature. In claim 6,
A real-time newborn heart rate measurement system characterized by observing/diagnosing correlation with disease through the analyzed data. In claim 1,
The biosignal sensing unit 100 is a real-time newborn heart rate measurement system characterized in that it uses biocompatible materials. In claim 1,
The fastening device 200 is a real-time newborn heart rate measurement system, characterized in that the newborn bed, bodysuit, innerwear, inner/outer wrap. In the method of measuring the vital signs of a newborn,
Step 1 of measuring the newborn's electrocardiogram and heart rate using a fixation device (200) along with stimulation and suction for initial treatment upon birth of a newborn;
Step 2 of moving to the neonatal room if the measured heart rate of the newborn is over 100 beats per minute and oxygen treatment using positive pressure ventilation if the measured heart rate of the newborn is less than 100 beats per minute;
If the heart rate is less than 100 beats per minute after proceeding with step 2, step 3 is oxygen treatment using positive pressure ventilation after securing the airway and checking posture;
Step 4 of repeating step 3 if the newborn's heart rate is less than 100 beats per minute after step 3;
If the heart rate is less than 100 beats per minute even after the above 4 steps, open the mouth and increase the pressure with suction to perform oxygen treatment using positive pressure ventilation;
After proceeding with step 5, if the measured heart rate is more than 100 beats per minute, move to the neonatal room for management; if the heart rate is less than 100 beats per minute, oxygen treatment with positive pressure ventilation; step 6;
If the heart rate is less than 100 beats per minute even after the above 6 steps, step 7 of performing positive pressure ventilation after tracheal intubation;
If the heart rate is less than 100 beats per minute after proceeding with step 7, step 8 of performing three cardiac massages and one positive pressure ventilation;
If the heart rate is not higher than 60 beats per minute even after the above 8 steps, proceed to step 9 of administering epinephrine (Epinephrine 1:10000 (0.1ml/kg)) along with 3 cardiac massages and 1 positive pressure ventilation, and then receive a warning. A real-time newborn heart rate measurement method characterized by: In claim 10,
A real-time newborn heart rate measurement method, characterized in that the oxygen treatment time in steps 2 to 7 is 30 seconds. In claim 10,
After proceeding with the above 9 steps, 3 cardiac massages and 1 positive pressure ventilation were performed. However, if the heart rate was less than 60 beats per minute, 3 cardiac massages and 1 positive pressure ventilation were repeated. If the number of repetitions exceeded 3, cardiac massages were performed 3 times. A real-time newborn heart rate measurement method characterized by administering epinephrine (Epinephrine 1:10000 (0.1ml/kg)) along with one positive pressure ventilation. According to claims 10 and 12,
A real-time newborn heart rate measurement method, characterized in that the time for three cardiac massages and one positive pressure ventilation is 60 seconds. According to claims 10 and 12,
A real-time newborn heart rate measurement method, characterized in that the cardiac massage 3 times, positive pressure ventilation 1 time, and epinephrine (Epinephrine 1:10000 (0.1ml/kg)) are performed for 3 minutes.