JP7439527B2 - Portable electrocardiogram device and biological information management system - Google Patents

Description

The present invention relates to a portable electrocardiogram device capable of measuring electrocardiogram waveforms in daily life, etc., and a biological information management system including the same.

A portable electrocardiogram measuring device (hereinafter also referred to as a "portable electrocardiogram device") that can immediately measure an electrocardiogram waveform when an abnormality such as chest pain or palpitations occurs in daily life has been proposed. Doctors, etc. can detect heart disease early and provide appropriate treatment based on electrocardiographic waveform data measured by the electrocardiographic device when symptoms such as palpitations occur at home or while out and about. becomes possible.

Conventionally, in such portable electrocardiographic devices, techniques have been proposed that focus on different electrocardiographic waveforms of the same subject. For example, Patent Document 1 discloses a technology that stores an individual's electrocardiographic waveform along with its variations, and performs personal authentication using the electrocardiographic waveform without being affected by the variations in the electrocardiographic waveform. Furthermore, when registering an electrocardiographic waveform, Patent Document 2 instructs the electrocardiographic sensor to be held at the center, left, right, top, or bottom of the conductor, and stores the electrocardiographic waveform in consideration of variations in the electrocardiographic waveform. , has disclosed a technique for performing personal authentication using electrocardiographic waveforms without being affected by variations in electrocardiographic waveforms.

Japanese Patent Application Publication No. 2012-176106 JP2017-51611A

The technologies disclosed in Patent Document 1 and Patent Document 2 both aim to use electrocardiographic waveforms for personal authentication, and focus on variations that appear in electrocardiographic waveforms that should be associated with the same subject. It is something. In contrast, there has been no technology that focuses on differences in electrocardiographic waveforms depending on the induction method when measuring electrocardiographic waveforms. However, since electrocardiographic waveforms differ depending on the guiding method, an electrocardiographic device that allows detecting electrocardiographic waveforms using multiple guiding methods cannot perform appropriate processing unless it is known which guiding method the electrocardiographic waveform was generated by.

In view of the above-mentioned problems, an object of the present invention is to provide a technique for determining which guiding method an electrocardiographic waveform is derived from when an electrocardiographic waveform is detected by a plurality of guiding methods. .

In order to solve the above problems, the portable electrocardiogram device according to the present invention includes:
an electrode section that detects the electrocardiogram waveform of the subject;
memory section,
a control unit;
Equipped with
The control unit includes:
Storing characteristic information specifying the electrocardiographic waveform in the memory unit as registered characteristic information of the subject for the electrocardiographic waveform of the subject obtained by each of a plurality of types of guidance methods;
A guidance method for detecting the electrocardiographic waveform based on the characteristic information acquired about the electrocardiographic waveform detected by the electrode unit of the subject and the registered characteristic information of the subject. It is characterized by determining the type of.

In this way, for multiple guidance methods, the feature information (registered feature information) for the electrocardiogram waveform of each subject and the feature information acquired for the electrocardiogram waveform of the subject detected by the electrode part Based on this, the portable electrocardiographic device can appropriately determine the type of guidance method used when the subject detects the electrocardiographic waveform. If the type of guidance method by which the electrocardiographic waveform was detected is appropriately determined in this way, the electrocardiographic waveform can be processed appropriately, so that the electrocardiographic waveform can be analyzed with high accuracy. Information useful for doctors' diagnosis based on electrocardiographic waveforms can be provided.
Characteristic information characterizing the electrocardiogram waveform includes, for example, P wave height and P wave width, Q wave height, PQ time, R wave height, S wave height, QRS width, T wave height and T wave width, QT time, and U wave height. One or more of the wave width and the U wave width, or a value calculated from one or more of these can be used as the parameter, but is not limited thereto. For example, by comparing the parameters obtained for the electrocardiogram waveform detected by the electrode section and the parameters stored as the registered characteristic information of the subject, The guidance method that is closer to the parameters acquired for the electrocardiogram waveform is determined to be the guidance method when the electrocardiogram waveform was detected.
The registered characteristic information may be obtained from an electrocardiogram waveform detected by the subject touching a part of his body with the electrodes of a portable electrocardiogram device, or may be obtained from an external device according to each lead method. Characteristic information of the subject's electrocardiographic waveform may also be used.

Furthermore, in the present invention,
The multiple types of induction methods include the I lead and V4 lead of the standard 12 lead method,
The characteristic information may include at least one of an R wave height, a T wave height, and an S wave height.

In this way, by employing characteristic information including at least one of R wave height, T wave height, or S wave height, which characterizes I lead and V4 lead more accurately, the type of guidance method can be accurately determined. can be determined.

Furthermore, in the present invention,
The detected electrocardiographic waveform and a determination result of the type of guidance method for the electrocardiographic waveform may be stored in the memory unit.

In this way, when a doctor reads an electrocardiogram waveform from a portable electrocardiogram device and uses it for diagnosis, etc., it is possible to also provide useful information regarding the type of lead used when detecting an electrocardiogram waveform. .

Furthermore, in the present invention,
comprising a notification unit that provides information to the subject,
The control unit receives the designation of the guidance method,
If the determination result of the type of guidance method for the detected electrocardiographic waveform is different from the designated guidance method, the notification unit may provide information regarding the guidance method.

In this way, when a doctor wants to specify the guidance method for electrocardiographic waveforms that the subject should collect among multiple guidance methods, the designation of the guidance method can be accepted, and the patient can receive the designated guidance method. If an electrocardiogram is measured using a different guidance method, the notification unit alerts the subject by providing information regarding the guidance method, such as information indicating that the guidance method is incorrect. It is possible to prompt measurement using the specified guidance method.

Moreover, the present invention
The portable electrocardiogram device;
a terminal comprising a terminal control unit, a terminal notification unit that provides information to the subject, and a terminal communication unit that transmits and receives information to and from the portable electrocardiographic device;
A biological information management system comprising:
In order to acquire the registered characteristic information of the subject, when the subject contacts the electrode part with the body according to any of the guidance methods, the terminal control unit, through the terminal notification unit, The method is characterized in that the subject is taught the guidance method.

In this way, when acquiring registered characteristic information, the subject can easily and clearly understand through the terminal notification unit which of the multiple guidance methods should be used to bring the electrode part into contact with the body. Therefore, it is possible to store appropriate registered feature information and accurately determine the type of guidance method.
The terminal is not limited to a portable terminal such as a smartphone, a tablet terminal, or a notebook PC, but may also be a stationary personal computer or the like.

Furthermore, in the present invention,
The control unit receives the designation of the guidance method,
If a determination result of the type of the guidance method for the detected electrocardiographic waveform is different from the designated guidance method, the terminal notification unit may provide information regarding the guidance method. .

In this way, when a doctor wants to specify the guidance method for electrocardiographic waveforms that the subject should collect among multiple guidance methods, the designation of the guidance method can be accepted, and the patient can receive the designated guidance method. If an electrocardiogram is measured using a different guidance method, the terminal notification section warns the subject by providing information regarding the guidance method, such as information indicating that the guidance method is incorrect. It can be used to remind people to take measurements using the specified guidance method. The designation of the induction method may be accepted by the terminal and transmitted to the portable electrocardiogram device via the terminal communication unit.

According to the present invention, when an electrocardiographic waveform is detected by a plurality of guiding methods, it is possible to provide a technique for determining which guiding method the electrocardiographic waveform is generated by.

FIG. 1 is a diagram illustrating the appearance of a portable electrocardiographic device according to a first embodiment. FIG. 2 is a functional block diagram of the portable electrocardiogram device according to the first embodiment. FIG. 3 is a functional block diagram of the smartphone according to the first embodiment. FIG. 4 is a flowchart illustrating the procedure of initial setting processing of the portable electrocardiographic device according to the first embodiment. FIG. 5(A) is a graph showing the electrocardiographic waveform of lead I measurement in the initial settings of the portable electrocardiographic device according to Embodiment 1, and FIG. 5(B) is an enlarged view of the electrocardiographic waveform for one beat. It is a diagram. FIG. 6(A) is a graph showing the electrocardiographic waveform of lead V4 in the initial setting of the portable electrocardiographic device according to Embodiment 1, and FIG. 6(B) is an enlarged view of the electrocardiographic waveform for one beat. It is. FIG. 7(A) is a diagram illustrating parameters for specifying an electrocardiographic waveform. FIG. 8 is a part of a flowchart illustrating the procedure of electrocardiogram measurement processing of the portable electrocardiogram device according to the first embodiment. FIG. 9 is a part of a flowchart illustrating the procedure of electrocardiogram measurement processing of the portable electrocardiogram device according to the first embodiment. FIG. 10(A) is a graph showing an electrocardiographic waveform measured by the portable electrocardiographic device according to Embodiment 1, and FIG. 10(B) is an enlarged view of the electrocardiographic waveform for one beat. . FIGS. 11A to 11J are diagrams showing electrocardiographic waveforms for one beat according to the standard 12-lead method excluding leads I and V4.

Hereinafter, specific embodiments of the present invention will be described based on the drawings.

<Embodiment 1>
An example of an embodiment of the present invention will be described below. However, unless otherwise specified, the dimensions, materials, shapes, relative positions, etc. of the components described in this embodiment are not intended to limit the scope of the present invention.

(Configuration of portable electrocardiogram device)
FIGS. 1A to 1F are diagrams showing an example of the configuration of a portable electrocardiogram device 100 according to the present embodiment. FIG. 1(A) is a diagram of the portable electrocardiographic device 100 viewed from the front. FIG. 1(B) is a diagram of the portable electrocardiographic device 100 viewed from below. FIG. 1(C) is a diagram of the portable electrocardiographic device 100 viewed from above. FIG. 1(D) is a diagram showing the left side of the portable electrocardiographic device 100 when viewed from the front. FIG. 1E is a diagram showing the right side of the portable electrocardiographic device 100 when viewed from the front. FIG. 1(F) is a diagram of the portable electrocardiographic device 100 viewed from the back. The vertical direction refers to the vertical direction on the paper with respect to the portable electrocardiographic device 100 in the posture shown in FIG. 1(A).

As shown in FIGS. 1A to 1F, the main body 1 of the portable electrocardiographic device 100 has a substantially quadrangular prism shape with rounded corners, and is flat between the front and back surfaces. A first electrode 2 is provided at the bottom of the portable electrocardiographic device 100. At the top of the portable electrocardiographic device 100, a second electrode 3 is provided on the left side when viewed from the front, and a third electrode 4 is provided on the right side. The upper part of the portable electrocardiographic device 100 has a smoothly curved shape so that the index finger of the right hand of the subject can easily contact it. On the front surface of the main body 1 of the portable electrocardiographic device 100, a measurement notification LED 5 and an abnormal wave detection LED 6 are arranged vertically. The measurement notification LED 5 is a light emitting element that lights up or blinks when an electrocardiogram waveform is measured. The abnormal waveform detection LED 6 is a light emitting element that lights up when an abnormal waveform is detected in the measured electrocardiographic waveform. By lighting the abnormal waveform detection LED 6, the subject is notified of the presence or absence of an abnormal waveform detected from the electrocardiographic waveform measurement data. On the left side of the main body 1 of the portable electrocardiogram device 100 when viewed from the front, a power switch 7, a power LED 8, a BLE communication button 9, a communication LED 10, a remaining memory indicator LED 11, and a battery replacement LED 12 are arranged vertically. ing. The power switch 7 is a press-down switch for turning on the power of the portable electrocardiocardial device 100, and the power LED 8 is a light emitting element that lights up when the power is turned on. The BLE communication button 9 is an operation component for functioning communication with a device compliant with the BLE (Bluetooth (registered trademark) Low Energy) system, and the communication LED 10 is a light emitting element that lights up during communication. Note that the communication function provided by the portable electrocardiogram device 100 is not limited to the BLE method, but may also be a wireless communication method such as infrared communication or information transmission using ultrasound, or a wired communication method connected via a cable or connector. Good too. The remaining memory display LED 11 is a light emitting element that indicates the state of free space in the memory section, which will be described later. The battery replacement LED 12 is a light-emitting element that lights up when the power of the power source (battery) included in the portable electrocardiocardial device 100 falls below a predetermined value to prompt battery replacement. Furthermore, a removable battery cover 13 is provided on the back side of the main body 1 of the portable electrocardiographic device 100.

Here, in the electrocardiogram measurement, for example, when lead I measurement is performed, the first electrode 2 provided at the bottom of the main body is brought into contact with the left palm while grasping the portable electrocardiogram device 100 with the right hand. . When grasping the portable electrocardiogram device 100, the index finger of the right hand is brought into contact with the second electrode 3, and the middle phalanx of the right index finger is brought into contact with the third electrode 4. For example, an electrocardiogram is measured while pressing the first electrode 2 provided at the bottom toward the left palm from the upper side of the main body where the second electrode 3 and third electrode 4 are provided. will be held. Here, the index finger of the right hand, its middle phalanx, and the palm of the left hand correspond to the body with which the electrode portion of the present invention is brought into contact.

Further, when V4 lead measurement is performed in the electrocardiogram measurement, the subject, for example, holds the portable electrocardiogram device 100 with the right hand and connects the first electrode 2 provided at the bottom of the main body to the left chest. Contact the skin slightly to the left of the epigastric region and below the nipple. When grasping the portable electrocardiogram device 100, the index finger of the right hand is brought into contact with the second electrode 3, and the middle phalanx of the right index finger is brought into contact with the third electrode 4. Then, electrocardiogram measurement is performed while pressing the first electrode 2 provided at the bottom in the direction of the measurement site from the upper side of the main body 1 where the second electrode 3 and the third electrode 4 are provided. . Here, the index finger of the right hand and its middle phalanx, and the skin slightly to the left of the epigastric region of the left chest and below the nipple correspond to the body with which the electrode portion of the present invention is brought into contact.

(Configuration of portable electrocardiogram device)
Next, the configuration of the portable electrocardiographic device 100 will be explained. FIG. 2 is a functional block diagram showing an example of the configuration of the portable electrocardiogram device 100 according to the present embodiment.

As shown in FIG. 2, the portable electrocardiogram device 100 includes an electrode section 101, an amplifier section 102, an AD (Analog to Digital) conversion section 103, a control section 104, and a timer section 105. . Furthermore, the configuration of the portable electrocardiocardial device 100 includes a memory section 106, a display section 107, an operation section 108, a power supply section 109, and a communication section 110. Control section 104, timer section 105, memory section 106, display section 107, operation section 108, power supply section 109, and communication section 110 are interconnected.

The electrode section 101 includes a first electrode 2 and a third electrode 4 that function as a pair of measurement electrodes, and a second electrode 3 that functions as a GND electrode. Electrocardiographic waveforms within a predetermined period of time are detected through the electrode section 101 that is in contact with the subject's skin. The electrocardiographic waveform detected by each electrode of the electrode section 101 is input to the amplifier section 102 connected to the electrode section. In the amplifier section 102, the signal detected by the electrode section 101 is amplified and output to the AD conversion section 103. In the AD conversion section 103 , the electrocardiographic waveform detection signal amplified through the amplifier section 102 is digitally converted and outputted to the control section 104 .

The timer section 105 is a means for receiving instructions from the control section 104 and counting various times or periods related to measurement of electrocardiographic waveforms.

The memory unit 106 includes a main storage device such as a ROM (Read Only Memory) and a RAM (Random Access Memory), as well as a long-term storage medium such as a flash memory. The memory unit 106 stores various programs related to measurement and analysis of electrocardiographic waveforms, and various information for detecting abnormal waveforms and the like. The display unit 107 is a means for displaying various information related to measurement of electrocardiographic waveforms. The display section 107 includes a measurement notification LED 5, an abnormal waveform detection LED 6, a power supply LED 8, a communication LED 10, a remaining memory display LED 11, and a battery replacement LED 12. The display unit 107 may include means for displaying various information using images and videos such as a liquid crystal display.

The operation unit 108 is a means for accepting operation input from the subject. The operation unit 108 includes a power switch 7 and a BLE communication button 9. The power supply unit 109 is a means for supplying electric power to make the portable electrocardiocardial device 100 function, and includes a battery, a secondary battery, and the like. The communication unit 110 is a communication interface that controls the transmission and reception of signals with a device such as the smartphone 200. Although BLE communication is an example of the communication function provided by the communication unit 110, other known wireless communication methods and wired communication methods can be employed.

(smartphone)
FIG. 3 is a block diagram showing the configuration of smartphone 200. As will be described later, the smartphone 200 cooperates with the portable electrocardiographic device 100 to configure a biological information management system.
The smartphone 200 includes a control unit 201, a touch panel display 202, an audio output unit 203 such as a speaker, a memory unit 204, an audio input unit 205 such as a microphone, an operation unit 206 such as a button, a power supply unit 207, and a portable electrocardiogram device 100. The communication unit 208 is a communication interface that controls the transmission and reception of signals using a method such as BLE communication between the terminal and the terminal. Since the smartphone 200, which is an example of a terminal capable of communicating with the portable electrocardiocardial device 100, can have a known configuration, it will not be described in detail. Here, the control unit 201 and the communication unit 208 correspond to the terminal control unit and the terminal communication unit of the present invention.

(Initial setting)
Initial settings performed during BLE communication between the portable electrocardiogram device 100 and a terminal such as a smartphone will be described below. FIG. 4 is a flowchart showing the processing procedure for this initial setting.

First, in the portable electrocardiogram device 100, the subject turns on the power by pressing the power switch 7 (step S101). On the other hand, on the smartphone 200, an application program for electrocardiogram measurement (hereinafter referred to as "app") is opened (step S201), and initial settings are performed. Here, the description will be made assuming that preparations such as association of the portable electrocardiogram device 100 with the smartphone 200 in which an electrocardiogram measurement application is installed and registration of the ID of the subject have been completed.

The app is set to collect information from various biological information measuring devices such as electrocardiogram measuring devices including portable electrocardiographic devices, blood pressure monitors, body fat monitors, and activity monitors. If there is a biological information measuring device to be added, the subject adds the biological information measuring device using the biological information measuring device addition function of the application (step S202).
Since there are various models of electrocardiogram measuring devices that can collect information using an app, the subject selects the applicable model of the portable electrocardiographic device 100 using the model selection function of the EKG (electrocardiogram measuring device) ( Step S203).

Next, a BLE connection is established between the portable electrocardiographic device 100 and the smartphone 200 according to a predetermined procedure (step S102, step S204).
When the BLE connection is established between the portable electrocardiogram device 100 and the smartphone 200, the smartphone 200 transmits a communication start request to the portable electrocardiogram device 100 (step S205).

In the portable electrocardiographic device 100 that has received the communication start request, the subject performs electrocardiographic waveform measurements using two lead methods, lead I measurement and V4 lead measurement (step S103). FIG. 5(A) shows an electrocardiogram waveform measured by lead I measurement. The electrocardiogram waveforms are continuous in time series from the top to the bottom. FIG. 5(B) is an enlarged view of one heartbeat of the electrocardiographic waveform shown in FIG. 5(A). FIG. 6(A) shows an electrocardiographic waveform measured by lead V4 measurement. The electrocardiogram waveforms are continuous in time series from the top to the bottom. FIG. 6(B) is an enlarged view of one heartbeat of the electrocardiographic waveform shown in FIG. 6(A). Then, the control unit 104 stores the electrocardiographic waveforms acquired by the two types of guidance methods in a predetermined area of the memory unit 106 (step S104). When the subject performs the I-lead measurement and the V4-lead measurement, the subject may refer to the instruction manual or use the app on the smartphone 200 to perform video or audio output through the touch panel display 202 or the audio output unit 203. , I-lead measurement, and V4-lead measurement may be provided to the subject. At this time, the touch panel display 202 and the audio output section 203 correspond to the terminal notification section of the present invention. Here, electrocardiographic waveform measurements are performed using two types of guidance methods, but the portable electrocardiographic device 100 may perform electrocardiographic waveform measurements using three or more types of guidance methods.

FIG. 7 shows the names of each part of a general electrocardiogram waveform. About P wave, P wave height and P wave width, About Q wave, Q wave height, About P wave and Q wave, PQ time, About R wave, R wave height, About S wave, S wave height, Q wave, R wave For the S wave, the QRS width, for the T wave, the T wave height and the T wave width, for the Q wave and the T wave, the QT time, and for the U wave, the U wave height and the U wave width are defined. One or more numerical values of each part of the electrocardiogram or a value calculated based on one or more numerical values is set as a parameter for specifying the waveform of the electrocardiogram. In order to distinguish between the I-lead measurement and the V4-lead measurement described above, it is effective to use at least one of the R-wave height, T-wave height, and S-wave height. By using the wave height as a parameter, the type of lead I and lead V4 can be determined with high accuracy. The parameters for specifying the electrocardiogram waveform are not limited to these. Different parameters may be set for each guidance method, or common parameters may be set. All parameters may be acquired regardless of the induction method. In step S104, the parameters thus set are acquired and stored in a predetermined area of the memory unit 106. However, the method of matching the electrocardiogram waveform of a specific lead type that was initially registered for the subject and the electrocardiogram waveform at the time of measurement of the subject is not limited to this, and the method of specifying the electrocardiogram waveform and the memory The data stored in section 106 can be selected as appropriate depending on the matching method. Here, the above-mentioned parameters correspond to the characteristic information for specifying the electrocardiographic waveform of the present invention, and the parameters stored in the predetermined area of the memory unit 106 in step S104 correspond to the registered characteristic information of the present invention.

Electrocardiogram measurement completion information is transmitted from the portable electrocardiogram device 100 to the smartphone 200 (step S105). When the smartphone 200 receives the electrocardiogram measurement end information from the portable electrocardiogram device 100 (step S206), the smartphone 200 finishes the initial setting (step S207).

When the initial settings are completed, the smartphone 200 transmits a communication termination request to the portable electrocardiogram device 100 (step S208). BLE disconnection is performed between the smartphone 200 and the portable electrocardiographic device 100 that received the communication termination request from the smartphone 200 according to a predetermined procedure (step S106, step S209).

When the BLE communication is disconnected, the power switch 7 of the portable electrocardiographic device 100 is turned off (step S107). The power switch 7 may be automatically turned off by the control unit 104 after a predetermined time has elapsed after the BLE is turned off, or may be turned off by the subject pressing the power switch 7. On the other hand, in the smartphone 200, after disconnecting the BLE communication, the application is closed (step S210). In this way, the initial settings of the portable electrocardiogram device 100 in cooperation with the smartphone 200 are completed.

(electrocardiogram measurement processing)
8 and 9 are flowcharts illustrating a procedure for measuring an electrocardiogram waveform while the portable electrocardiogram device 100 and a terminal equipped with a BLE communication function, such as a smartphone 200, perform BLE communication. and FIG. 9 show a series of procedures.

First, the power switch 7 of the portable electrocardiocardial device 100 is pressed to turn on the power (step S301). On the other hand, on the smartphone 200, an application for electrocardiogram measurement is opened (step S401). The following description assumes that registration of the subject's ID and the like has been completed during the above-mentioned initial setting.

In the portable electrocardiogram device 100, the electrode contact state is detected (step S302).
Specifically, when performing lead I measurement using the portable electrocardiograph device 100, the second electrode 3 is brought into contact with the fingerprint portion of the tip of the index finger of the right hand, and the third electrode 4 is brought into contact with the middle phalanx of the right index finger. let Then, the left palm is brought into contact with the first electrode 2. Further, when performing V4 lead measurement using the portable electrocardiogram device 100, the second electrode 3 is brought into contact with the fingerprint portion of the tip of the index finger of the right hand, and the third electrode 4 is brought into contact with the middle phalanx of the right index finger. Then, the first electrode 2 is brought into contact with the skin slightly to the left of the epigastric region of the left chest and below the nipple. The electric signals acquired through the electrodes 2, 3, and 4 are amplified by the amplifier section 102, and digitally converted by the AD conversion section to generate a contact state detection signal. The contact state detection signal generated in this way is transmitted to the control unit 104, and the contact state between the subject and each of the electrodes 2, 3, and 4 is detected.

Next, a BLE connection is established between the portable electrocardiographic device 100 and the smartphone 200 according to a predetermined procedure (step S303, step S402).
When the BLE connection is established between the portable electrocardiogram device 100 and the smartphone 200, the smartphone 200 transmits a communication start request to the portable electrocardiogram device 100 (step S403).
The portable electrocardio device 100 that has received the communication start request transmits information indicating the electrode contact state to the smartphone 200 (step S304). The smartphone 200 that has received the information indicating the electrode contact state displays the electrode contact state on the touch panel display 202 or the like to notify the subject that each electrode 2, 3, 4 is in normal contact.

The control unit 104 determines whether a predetermined period of time has elapsed since the electrode contact state was maintained (step S305).
If the determination in step S305 is No, the process returns to step S302. However, in this case, since the BLE connection has already been established, step S303 and the processes of steps S402 and S403 on the smartphone 200 side are omitted.
If it is determined Yes in step S305, the control unit 104 starts electrocardiogram measurement (step S306).

When the electrocardiogram measurement is started, the portable electrocardiogram device 100 performs streaming communication with the smartphone 200, and transmits electrocardiogram waveform information and measurement time information to the smartphone 200 (step S307). The measurement time information is information regarding the elapsed time from the start of electrocardiogram measurement, which is counted by the timer section 105. Here, the measurement time information is the remaining measurement time obtained by subtracting the elapsed time from the start of electrocardiogram measurement from the predetermined time. This is information indicating. Information on the elapsed time from the start of electrocardiographic measurement may be transmitted from the portable electrocardiographic device 100 to the smartphone 200, and subtraction processing from the predetermined time may be performed on the smartphone 200 side. Meanwhile, the smartphone 200 receives electrocardiographic waveform information and measurement time information from the portable electrocardiographic device 100 (step S406).

(Guidance type determination process)
At this time, the control unit 104 of the portable electrocardiogram device 100 uses the measured electrocardiogram waveform and the parameters that specify the electrocardiogram waveform according to each lead method of the subject stored in the memory unit 106. The type of guidance is determined by which guidance method the measurement is being performed (step S305). FIG. 10(A) shows an example of a measured electrocardiographic waveform. The electrocardiogram waveforms are continuous in time series from the top to the bottom. FIG. 10(B) is an enlarged view of one heartbeat of the electrocardiographic waveform shown in FIG. 10(A). The parameters described above are extracted for the measured electrocardiographic waveforms shown in FIGS. 10(A) and 10(B). Then, the parameters extracted in this way and the electrocardiograms from the subject's lead I measurement and lead V4, which were measured (step S103) and stored in the memory unit 106 (step S104) during the initial setting. Compare the parameters for the shape. For example, by comparing the differences (absolute values) of parameters, it is determined that the guidance method with which the measured electrocardiogram waveform is closer is the guidance method used for the electrocardiogram measurement. Here, the electrocardiographic waveform shown in FIG. 10(B) is higher than the electrocardiographic waveform obtained by lead I measurement shown in FIG.
) is close to the electrocardiographic waveform obtained by the V4 lead measurement, and therefore the lead type of the electrocardiographic measurement is determined to be the V4 lead measurement.

Then, information on the determination result of the determined lead type is transmitted from the portable electrocardiographic device 100 to the smartphone 200 (step S308). On the other hand, the smartphone 200 receives information on the determination result of the lead type from the portable electrocardiographic device 100 (step S407).

The smartphone 200 displays the electrocardiogram waveform and measurement time on the touch panel display 202 (step S408). This notifies the subject that the electrocardiogram measurement is being performed normally and the remaining measurement time.
At this time, the determination result of the guidance type may be displayed on the touch panel display 202 of the smartphone 200. The guidance type displayed on the touch panel display 202 can be used to instruct the subject in the correct measurement posture. Further, if a guidance type different from the guidance method intended by the subject is displayed on the touch panel display 202, it is possible to prompt the subject to take the measurement again in the correct measurement posture.

It is determined whether a predetermined measurement time (for example, 30 seconds) has elapsed since the electrocardiogram waveform measurement was started (step S309).
If the determination in step S309 is No, the process returns to step S305. In this case, since the lead type for electrocardiogram measurement has already been determined and the determination result has been sent to the smartphone, the determination and transmission of the lead type for electrocardiogram measurement will be omitted. However, the determination of the type of guidance for electrocardiogram measurement and the transmission of the determination result to the smartphone 200 may be performed multiple times.
If the determination is Yes in step S309, the control unit 104 analyzes the electrocardiogram waveform (step S310). By analyzing the electrocardiogram waveform based on the lead type determination result, accurate analysis becomes possible.

During the analysis of the electrocardiogram waveform, the control unit 104 transmits information indicating that the electrocardiogram waveform is being analyzed to the smartphone 200 (step S311). When the smartphone 200 receives information indicating that the electrocardiogram waveform is being analyzed from the portable electrocardiogram device 100 (step S410), the smartphone 200 displays information indicating that the electrocardiogram waveform is being analyzed on the touch panel display 202. (Step S411).

When the electrocardiogram waveform analysis is completed, the control unit 104 stores the lead type determination result, the electrocardiogram waveform, and the analysis result in a predetermined area of the memory unit 106 (step S312). By storing the lead type determination result together with the electrocardiogram waveform in a predetermined area of the memory unit 106, useful information can be provided when a doctor reads the electrocardiogram waveform and uses it for diagnosis, etc. . The lead type determination result, electrocardiographic waveform, and analysis result may be saved only on the smartphone 200 side without being saved in the memory unit 106 of the portable electrocardiographic device 100. Further, only one of the lead type determination result, the electrocardiographic waveform, and the analysis result may be stored in the memory unit 106 of the portable electrocardiographic device 100.
If an abnormal wave is detected by analyzing the electrocardiogram waveform, the control unit 104 blinks the abnormal wave detection LED 13 to notify the subject of the abnormal wave detection (step S313).

Further, when the analysis of the electrocardiogram waveform is completed, the control unit 104 transmits the analysis result to the smartphone 200 by high-speed data communication (step S314). At this time, the smartphone 200 receives the analysis results transmitted from the portable electrocardiographic device 100 (step S412).

If the portable electrocardiographic device 100 has untransmitted electrocardiographic waveform data, lead type determination result data, and analysis results, the control unit 104 uses high-speed data communication to send these information starting from the newest one. The information is sequentially transmitted to the smartphone 200. At this time, the smartphone 200 receives unsent electrocardiographic waveform data, lead type data, and analysis results from the portable electrocardiographic device 100 (step S413), and stores them in a predetermined area of the memory unit 204. Then, the smartphone 200 displays the latest electrocardiogram waveform and the analysis results, such as whether the electrocardiogram measurement result was normal or an abnormal wave was detected, on the touch panel display 202 (step S414).

When the portable electrocardiographic device 100 completes transmitting the untransmitted electrocardiographic waveform data, lead type determination result data, and analysis results (step S316), in response to a communication termination request transmitted from the smartphone 200 (step S415), , disconnects the BLE communication (step S317). Corresponding to the disconnection of the BLE communication in the portable electrocardiograph device 100, the BLE communication is also disconnected on the smartphone 200 side (step S416).

After disconnecting the BLE communication, the power switch 7 is turned off in the portable electrocardiographic device 100 (step S318). The power switch 7 may be automatically turned off by the control unit 104 after a predetermined time has elapsed after the BLE is turned off, or may be turned off by the subject pressing the power switch 7. On the other hand, in the smartphone 200, after disconnecting the BLE communication, the application is closed (step S417). In this way, the electrocardiogram measurement in collaboration with the smartphone 200 in the portable electrocardiogram device 100 is completed.

<Embodiment 2>
Embodiment 2 of the present invention will be described below. The configurations of the portable electrocardiogram device 100 and the smartphone 200 are the same as those in Embodiment 1, so the description thereof will be omitted. The portable electrocardiographic device 100 according to the present embodiment differs from the first embodiment in the initial setting procedure for electrocardiogram measurement and the determination of the lead type associated therewith. Therefore, only the different parts from the first embodiment will be explained, and the same The explanation of the procedure will be omitted.

In the first embodiment, in the portable electrocardiogram device 100, lead I measurement and lead V4 measurement are registered in the initial setting of electrocardiogram measurement. When the subject makes initial settings for lead V4 measurement, as described above, while holding the portable electrocardiographic device 100 with the right hand, place the first electrode 2 provided at the bottom of the main body into the epigastric fossa of the left chest. Contact the skin slightly to the left and below the nipple. The subject assumes such a measurement posture by referring to the instruction manual or following guidance displayed on the touch panel display 202 of the smartphone 200 or output from the audio output unit 203. Furthermore, since there are individual differences in the shape and position of the heart of the subject, it is difficult to bring the first electrode 2 into contact with an appropriate position on the chest. Regarding lead I, compared to lead V4, it is easier for the subject to contact the first electrode 2 at the appropriate site, but there is a possibility that the contact position of the first electrode on the left palm may shift from measurement to measurement. There is.

Therefore, in this embodiment, during initial settings, the measurement posture is changed for each induction method, and the electrocardiographic waveform is measured a plurality of times (N times) by slightly shifting the electrode contact position. Then, in step S104, the control unit 104 obtains N set parameters (for example, R wave height, T wave height, and S wave height) for each guidance method, and The data is saved in a predetermined area of the memory unit 106. In step S101, when determining the lead type of the measured electrocardiographic waveform, each parameter of the measured electrocardiographic waveform is compared based on the difference with each of these N saved parameters.
In this way, individual differences in the shape and position of the heart of the subject can be absorbed, and the type of guidance can be determined with high accuracy. Moreover, even if the part to which the subject contacts the electrode during measurement varies, the type of guidance can be determined with high accuracy.

(Modification 1)
In the first and second embodiments described above, the subject determines the lead type when measuring the electrocardiogram waveform with the portable electrocardiogram device 100, and uses it for analyzing the electrocardiogram waveform. Therefore, the subject may specify the type of lead when measuring an electrocardiogram waveform using the portable electrocardiogram device 100. In such a case, the lead type may be set directly on the portable electrocardiogram device 100, or the lead type setting information may be imported and set from a terminal operated by the doctor via the communication unit 110. Accordingly, in the portable electrocardiographic apparatus 100, information on the designated lead type is stored in a predetermined area of the memory unit 106. Then, if the determination result of the lead type when the subject measures the electrocardiogram waveform is different from the designated lead type, the control unit 104 causes the measurement notification LED 12 or the abnormal wave detection LED 13 to indicate the measurement notification or abnormal wave detection result. By blinking in a mode different from detection, the subject may be notified that the guidance type is different from the designated guidance type. Additionally, an LED, a speaker, a vibrator, or the like may be separately provided in the portable electrocardiographic device 100 to notify the subject that the lead type is different from the designated lead type. In this case, the measurement notification LED 12 or the abnormal wave detection LED 13, a separately provided LED, a speaker, a vibrator, etc. correspond to the notification section of the present invention. Further, the control unit 104 transmits information indicating that the guidance type is different from the designated guidance type to the smartphone 200, causes the touch panel display 202 to display that the guidance type is different from the designated guidance type, or outputs audio. This may be notified by voice through the section 203. Here, the touch panel display 202 and the audio output section 203 correspond to the terminal notification section of the present invention.

(Modification 2)
In Embodiments 1 and 2 described above, the electrocardiogram waveforms of two lead methods, lead I measurement and lead V4 measurement, are registered at the time of initial setting as multiple types of lead methods, and any of these two lead methods is registered. However, the guidance methods used for registration and determination are not limited to these. FIGS. 11(A) to 11(J) show examples of normal electrocardiographic waveforms in electrocardiographic measurement using the standard 12-lead method, excluding leads I and V4. FIG. 11(A) is lead V1, FIG. 11(B) is lead V2, FIG. 11(C) is lead V3, FIG. 11(D) is lead V5, FIG. 11(E) is lead V6, FIG. 11(F) is lead II, Figure 11 (G) is lead III, Figure 11 (H) is lead aVR, and Figure 11 (I) is lead aVL.
FIG. 11(J) is an electrocardiogram waveform measured by the aVF lead.

Here, leads V1 to V6 are the potential difference between an indifferent electrode connecting the left and right upper limbs and lower limbs and a point on the anterior chest wall. In the case of the portable electrocardiogram device 100, lead V1 is the right edge of the sternum between the 4th intercostals, lead V2 is the left edge of the sternum between the 4th intercostals, and lead V3 is the leads V2 and V4 (more precisely, on the midclavicular line of the 5th intercostal space). The first electrode 2 is in contact with the anterior axillary line of the 5th intercostal space for lead V5, and the middle axillary line of the 5th intercostal space for lead V6, the index finger of the right hand is the second electrode 3, and the middle phalanx of the right index finger is the third electrode. 4, electrocardiogram measurement is possible. Here, the index finger of the right hand, its middle phalanx, and each point on the anterior chest wall mentioned above correspond to the body with which the electrode part of the present invention is brought into contact.

Regarding these lead methods, as explained for lead I and lead V4, parameters for identifying the subject's electrocardiogram waveform are extracted and saved during initial settings, and parameters are extracted from the electrocardiogram waveform measured at the time of measurement. The type of guidance can be determined by comparing the extracted parameters and determining which guidance method the electrocardiographic waveform is similar to. If electrocardiogram measurements can be performed using more lead methods in this way, it will be possible to obtain multifaceted information about the subject's cardiac activity, which will provide more useful information for the diagnosis and treatment of heart disease. .

Lead II is the potential difference between the right upper limb and lower limb, lead III is the potential difference between the left upper limb and lower limb, aVR lead is the potential difference between the right upper limb and the indifferent electrode that connects the left upper limb and lower limb, and aVL lead is the potential difference between the right upper limb and lower limb. The aVF lead is the potential difference between the indifferent electrode and the left upper limb, and the lower limb and the indifferent electrode that connects the right upper limb and the left upper limb. In the case of the portable electrocardiogram device 100, the right upper limb is the index finger of the right hand, the left upper limb is the index finger of the left hand, which is in contact with the second electrode 3, the middle segment thereof is in contact with the third electrode 4, and the lower limb is the base of the left foot. is brought into contact with the first electrode. Here, these parts correspond to the body with which the electrode part of the present invention is brought into contact.

Regarding these guidance methods, each lead type can be identified by using parameters for specifying the electrocardiographic waveform, as described for lead I and lead V4.

(Modification 3)
In the first and second embodiments described above, data for determining the type of guidance, such as parameters regarding electrocardiographic waveforms by each guidance method, are measured and stored at the time of initial setting. At the time of electrocardiogram measurement, data such as parameters of the electrocardiogram waveform whose lead type has been determined may be used to update data such as parameters saved at the time of initial setting. The update frequency may be set as appropriate. In the case of the first embodiment, the parameters corresponding to the guidance type stored in a predetermined area of the memory are overwritten and updated. In the case of the second embodiment, for example, the data is updated by sequentially overwriting the oldest data among the N times of stored data.
If a long period of time has passed since the initial setting, the electrocardiogram waveform may change due to aging or disease symptoms. As mentioned above, by updating data such as electrocardiogram waveform parameters saved at the time of initial setting with data at the time of measurement, it is possible to more accurately determine the lead type in consideration of the patient's condition. I can do it.

1... Portable electrocardiogram device 101... Electrode section 104... Control section 106... Memory section

Claims (6)

an electrode section that detects the electrocardiogram waveform of the subject;
memory section,
a control unit;
Equipped with
The electrode part is
Any two of the plurality of types of guidance methods include electrodes that are brought into contact with different parts of the body of the subject,
The control unit includes:
storing characteristic information specifying the electrocardiographic waveform in the memory unit as registered characteristic information of the subject for the electrocardiographic waveform of the subject obtained by each of the plurality of types of guidance methods;
A guidance method for detecting the electrocardiographic waveform based on the characteristic information acquired about the electrocardiographic waveform detected by the electrode unit of the subject and the registered characteristic information of the subject. A portable electrocardiogram device characterized in that it determines the type of an electrocardiogram. The multiple types of induction methods include the I lead and V4 lead of the standard 12 lead method,
The portable electrocardiographic device according to claim 1, wherein the characteristic information includes at least one of an R-wave height, a T-wave height, and an S-wave height. The portable electrocardiographic device according to claim 1 or 2, wherein the detected electrocardiographic waveform and a determination result of the type of the induction method for the electrocardiographic waveform are stored in the memory unit. comprising a notification unit that provides information to the subject,
The control unit receives the designation of the guidance method,
If a determination result of the type of the guidance method for the detected electrocardiographic waveform is different from the specified guidance method, the notification unit provides information regarding the guidance method. The portable electrocardiographic device according to any one of Items 1 to 3. A portable electrocardiogram device according to any one of claims 1 to 3,
a terminal comprising a terminal control unit, a terminal notification unit that provides information to the subject, and a terminal communication unit that transmits and receives information to and from the portable electrocardiographic device;
A biological information management system comprising:
In order to obtain the registered characteristic information of the subject, when the subject contacts the electrode section with the body according to any of the guidance methods, the terminal control section, through the terminal notification section, A biological information management system characterized by teaching the subject the guidance method. The control unit receives the designation of the guidance method,
If the determination result of the type of guidance method for the detected electrocardiographic waveform is different from the specified guidance method, the terminal notification unit provides information regarding the guidance method. The biological information management system according to claim 5.

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