WO2023176779A1 - Electrocardiographic examination method - Google Patents

Abstract

This electrocardiographic examination method utilizes a garment, measurement electrodes, and a measurement device, wherein the method is: characterized by including (1) a step in which build information of an examinee is obtained, (2) a step in which, in accordance with the build information of the examinee, a garment size is selected from among at least two different sizes, (3) a step in which the selected garment, the measurement electrodes, and the measurement device are transferred to the examinee, (4) a step in which the examinee personally determines electrode positions using the garment, (5) a step in which the examinee personally arranges the measurement electrodes at the determined electrode positions, and (6) a step in which electrocardiographic measurement is begun; and characterized in that electrode positions appropriate for electrocardiographic examination are indicated on the garment, and that the garment has no function of acquiring or transmitting electrocardiographic signals, so even without the garment, electrocardiographic measurement can be carried out using the measurement electrodes and the measurement device.

Description

Electrocardiography method

The present invention relates to a biopotential testing method, in particular an electrocardiogram testing method, in which a patient can use clothing to correctly identify electrode positions and wear the electrodes themselves.

Ischemic heart disease is the leading cause of death worldwide in recent years, accounting for 16% of all deaths. Ischemic heart disease refers to a disease in which blood flow to the myocardium is obstructed due to occlusion or narrowing of the coronary arteries, causing damage to the heart. Electrocardiograms, especially 24-hour electrocardiograms using a Holter monitor, are effective in detecting this disease. be. Conventional Holter electrocardiographs are difficult to wear unless you are a medical worker, requiring patients to wear them at the hospital and then take them off again 24 hours later. In addition, since the device cannot be removed while it is being worn, there are inconveniences such as not being able to take a bath. To solve this problem, for example, Non-Patent Document 1 discloses a service in which patients receive a Holter electrocardiograph by mail, wear it themselves, and undergo a NASA-guided 24-hour electrocardiogram test. In this service, electrocardiogram data is transmitted to an iPhone (registered trademark) using Bluetooth (registered trademark), and the data is transmitted from the iPhone to a cloud server via the Internet. Patients will not need to go to the hospital, and will be able to remove the device before taking a bath and put it back on after taking a bath.

For electrocardiography tests that patients wear themselves, one-lead Holter electrocardiographs, which use tools to guide the placement of electrodes, are becoming popular from the standpoint of test accuracy and simplicity. For example, Non-Patent Document 2 discloses a method of manually placing the target at the flattest part of the upper left chest, one finger below the clavicle, and at the center of the left pectoralis major muscle. Furthermore, Non-Patent Document 3 discloses a method of manually determining the electrode position by placing a template made of paper two fingers below the clavicle of the left chest.

From the perspective of patient comfort, clothing-type electrocardiographs are also becoming popular. For example, Non-Patent Document 2 discloses a case in which latent atrial fibrillation was detected in a young subject under 65 years old by measuring the electrocardiogram using a T-shirt type electrocardiograph for about two months. The test subject chose either an M or L T-shirt with measurement electrodes placed on the right and left chest, and wore it himself to measure the electrocardiogram using lead CC5. The electrocardiogram data measured by the communication device is sent to a smartphone via Bluetooth, and then from the smartphone to a data server via a 4G network.

Furthermore, Non-Patent Document 3 discloses a T-shirt type electrocardiograph using a conductive silver paste in the form of a film for electrodes and wiring. Electrocardiograms are measured using CC5 leads using measurement electrodes on the left and right chest, and a neutral electrode is placed near the manubrium of the sternum as a ground. The area around the manubrium of the sternum is thought to have been used as a ground because it is less susceptible to myoelectric effects. In this document, the tests were carried out with the subjects having a height of 170.0±1.4 cm and a weight of 65.8±6.3 kg, with the physiques of the subjects being somewhat similar.

The electrocardiograms in Non-Patent Documents 1 to 5 are one-lead electrocardiograms, but in Non-Patent Document 6, for example, there is a six-lead electrocardiogram using a monopolar chest lead in which stretchable wiring and measurement electrodes are formed inside a commercially available compression shirt. is disclosed. Although it is not specified in this document, there was only one subject and it seems that physique was not taken into consideration. Further, Patent Document 1 describes a clothing-type electrocardiographic testing method that can be easily worn at home without a medical professional (paragraph [0052]) by adjusting the size of the clothing to the body physique (paragraph [0048]). .

Furthermore, Patent Document 2 discloses a 12-lead electrocardiograph that uses a band-shaped electrode band that is attached to the chest rather than a shirt-like shape. Paragraph [0008] states that minimally trained or untrained people perform an accurate ECG test, and paragraphs [0066] and [0067] state that the size of the electrode band should be adjusted according to the patient's physique, etc. Determining is also described.

Further, Non-Patent Document 7 discloses a band-shaped 12-lead electrocardiogram measurement made of textile. It is assumed that it is mainly intended for use by medical personnel for emergency lifesaving purposes, but the only operation required is to wrap a strip of cloth with measuring electrodes placed around the patient's chest, aligning them with two landmarks: the midline and the armpit. The measurement electrode can be placed in the correct position, and by selecting S, M, L, or LL according to the patient's body size according to the guideline written on the band, the electrode position can be finely adjusted. This enables accurate electrocardiogram measurement without the need for adjustments.

China Utility Model No. 211355458 JP2020-163220A

Takami, M. , et al. Circulation Reports (2021): CR-21. https://www. mesa-nhlbi. org/PublicDocs/MESAExam6Forms/V6_ZioPatchStartGuide. pdf https://www. cardiocinsightinc. com/content/uploads/2020/04/PatientApplicationGuide_Final_patientprinting. pdf Fukuma, N. , et al. Scientific reports 9.1 (2019): 1-6. Shiozawa Shigehiro. Biomedical Engineering 54.3 (2016): 135-138. Jun Hagiwara, et al. Collection of papers from the Electronics Packaging Academic Conference 32nd Electronics Packaging Academic Conference. Electronics Packaging Society of Japan, 2018. https://news. mynavi. jp/article/20180117-572956/

The inventors have developed a Holter electrocardiograph that can be used comfortably by allowing patients to wear it themselves, eliminating the need to come to the hospital to have a medical professional wear it, and allowing patients to wear it while taking a bath. When we investigated electrocardiography, we realized that there were various problems.

One of the problems noticed by the inventors is the measurement electrode positioning work. In the case of a one-lead electrocardiogram, for example, as in Non-Patent Document 3 and Non-Patent Document 4, it is said that the examinee can make his or her own decision based on manual text and illustrations. But not everyone understands terms like clavicle and pectoralis major. In addition, it is difficult to directly see the area below the collarbone, so you have to put it on while taking a picture of yourself in a mirror, which is also not easy.

In the 12-lead Patent Document 1, paragraph [0057] specifies that the first placement indicator is the sternum and the second placement indicator is the left nipple. However, with this method, although it is possible to understand whether it is above or below the nipple using arrows, etc., the sternum region cannot be easily understood by a patient without medical knowledge. Furthermore, it is necessary to place electrodes on the right shoulder, left shoulder, left lower abdomen, etc. via cables, but it is difficult to know where to place them on the shoulder or abdomen without medical knowledge.

Furthermore, Non-Patent Document 5, which also uses 12 leads, discloses the use of two landmarks on the patient's midline and under the armpit. Non-patent Document 5 does not seem to be intended for non-medical workers, so there is no problem, but if a non-medical worker were to wear it, it would not be easy, and if a non-medical worker were to wear it, it would be difficult for them to wear it themselves. It is difficult to measure the physique of a person by oneself using a belt, and the midline cannot be easily aligned, making it difficult even if one has medical knowledge.

In clothing-type electrocardiographs such as those disclosed in Non-Patent Document 2, Non-Patent Document 3, Non-Patent Document 4, and Patent Document 2, it is possible to adjust the electrode position depending on the size of the shirt. However, no specific method for adjusting the shirt size to the patient's physique is disclosed.

The second problem noticed by the inventors is related to the clothing-type electrocardiograph. Clothing-type electrocardiographs such as those disclosed in Non-Patent Document 2, Non-Patent Document 3, Non-Patent Document 4, and Patent Document 2 are expensive and difficult for patients to purchase, so they are expected to be lent to patients. be done. However, there are patients who have psychological resistance to wearing underwear that has been worn by someone else, even if it has been washed. Additionally, in the hot summer months, people do not wear many layers of clothing, so they must live with a clothing-type electrocardiograph visible.

The third problem that the inventors noticed is maintenance. In the testing method by mail as in Non-Patent Document 1, it is easy to check the operation of the Holter electrocardiograph when it is returned. There are no hygiene issues because only the disposable gel electrodes come into contact with the patient's body. However, in the case of electrocardiogram measurement using clothing, the patient's sweat and dirt adhere to the clothing, so a washing step is required, which is not necessary for the device as in Non-Patent Document 1. The T-shirt type electrocardiograph of Non-Patent Document 2 is a commercially available product, and it is assumed that the purchaser owns it and washes it at home. However, in the case of electrocardiographic tests for medical examinations and health checkups, more careful operation confirmation is required because not only the device being measured but also the clothing that corresponds to the cable deteriorates. As noted in Non-Patent Literature 2 and Non-Patent Literature 3, the conventional electrocardiogram measurement using clothing focuses on the comfort of clothing, and the ease of having one's own shirt and the comfort of wearing it on other people. Psychological considerations for hygiene, such as not wanting to wear clothes, were important, and using someone else's clothing was seen as a negative factor for patients.　

The present invention has been made in view of the above circumstances, and aims to realize an electrocardiographic testing method that can solve the above problems at once. More specifically, we provide an electrocardiogram testing method that does not require a visit to the hospital and enables advanced diagnosis by allowing the patient to attach the electrocardiogram measurement electrodes themselves without requiring any special knowledge. The purpose is to

As a result of intensive studies, the present inventors identified clothing having a neckline surrounding the neck as disclosed in Non-patent Document 2, Non-patent Document 3, Non-patent Document 4, and Patent Document 2 to identify the position of the patient's body. By using it as a tool to accurately estimate the position of the measurement electrode, the clothing does not measure electrocardiograms, and the system allows the clothing to be separated from the measurement electrodes and measurement device, allowing patients to wear it themselves. We have found that it is possible to achieve both this and the ability for patients to spend a comfortable time without having to wear clothing worn by others.

The developers of general electrocardiographs, which are not clothing-based, had no knowledge of apparel, so it was not easy to determine the anatomical position of patients based on clothing. On the other hand, apparel engineers who develop clothing-type electrocardiographs are not so interested in specifying anatomical parts, and as shown in Non-patent Document 2, Non-patent Document 3, Non-patent Document 4, and Patent Document 1, No specific method for identifying target locations by size was presented. Furthermore, since the goal of apparel manufacturers is to increase profits by increasing the added value of clothing, they have not come up with the idea of removing the electrocardiogram measurement function from clothing and making it possible to perform measurements without clothing. Ta.

The inventors have developed clothing that has accurate electrode position information based on body physique information in advance, and does not have an electrocardiogram function, making it cheaper for patients to purchase on their own. The present invention has been completed by not only reducing psychological resistance, but also by preventing deterioration caused by washing from affecting electrocardiogram measurement, since even if the clothes are reused, they are only worn when determining the position.

In order to achieve the above object, one aspect of the present invention provides an electrocardiographic testing method comprising a measuring electrode, a measuring device, and clothing, including (1) obtaining physical information of the examinee; (3) handing over the selected clothing, measurement electrodes, and measurement device to the patient; (4) allowing the patient to determine the electrode position by themselves using the clothing; (5) a step in which the patient himself/herself places the measurement electrode at the determined electrode position; and (6) a step in which the electrocardiogram measurement is started, and the clothing has at least two or more different sizes. The clothing has a neckline that encircles the neck, and the appropriate electrode position for electrocardiographic testing is indicated, and the clothing does not have the function of acquiring or transmitting electrocardiographic signals, This electrocardiographic testing method is characterized in that electrocardiographic measurements can be performed without the use of clothing.

According to one aspect of the present invention, even a patient without medical knowledge can take advantage of the characteristics of apparel to accurately place measurement electrodes using clothing suitable for his/her physique, and can perform an electrocardiogram test himself. Moreover, since the clothing can be taken off during the measurement, the patient can wear whatever clothes he or she likes. Furthermore, since the clothing does not have an electrocardiogram measurement function, it is inexpensive, and it is easy for the patient to have his or her own clothing. As a result, there is no need to come to the hospital to have a medical worker put it on, and you can even take a bath, allowing you to spend a long time comfortably during electrocardiogram tests.

As another aspect of the present invention, after the above-mentioned step (6) is completed, (7) the patient returns the measurement device, (8) the step of reporting the electrocardiogram results to the patient, ( 9) Preferably, the electrocardiographic testing method includes a step of confirming the operation of the measuring device. This allows the electrocardiogram test service provider to easily perform maintenance and inspection, and improves the reliability of the electrocardiogram test. It does not matter which step (8) or (9) comes first as long as it comes after (7).

As yet another aspect of the present invention, it is preferable that the clothing has an opening at the electrode position. Thereby, after putting on clothes, the measurement electrodes can be placed on the body using the opening as a guide, and then the clothes can be taken off.

As yet another aspect of the present invention, it is preferable to include a mechanism that can fix the measurement electrode at the electrode position inside the clothing. Thereby, it is possible to fix the measurement electrode before putting on the clothes, place the measurement electrodes on the body after putting on the clothes, and then remove the measurement electrodes from the clothes and take off only the clothes.

As still another aspect of the present invention, it is preferable that the electrocardiographic testing method is characterized in that the physique information includes height. Among the physique information, height is effective for estimating the distance of the assumed height of the fifth intercostal space.

As still another aspect of the present invention, in the electrocardiographic testing method in which the number of leads is 1, the height is H, and a distance D1 is vertically downward from the center point P of a line segment connecting the left and right vertices of the neckline with a straight line. The lower electrode position is within a circle within a radius of 5 cm around the lower electrode position, and the upper electrode position is within a circle within a 5 cm radius around a position 8 to 15 cm vertically upward from the lower electrode position, and H and D1 are It is preferable that the electrocardiographic testing method is characterized by satisfying the relationship of the following formula [A]. This makes it possible to specify the estimated height of the fifth intercostal space, which is a guideline for the heart position, from height information, and perform one-lead electrocardiogram measurement above it.
D1 = [(H - 94.690) / 2.47] [A]

As still another aspect of the present invention, in the electrocardiographic testing method in which the number of leads is 1, the height is H, and a distance D1 is vertically downward from the center point P of a line segment connecting the left and right vertices of the neckline with a straight line. The lower electrode position is within a circle within a radius of 5 cm around the lower electrode position, and the upper electrode position is within a circle within a 5 cm radius around a position 8 to 15 cm vertically upward from the lower electrode position, and H and D1 are It is preferable that the electrocardiographic examination method is characterized by satisfying the following formula [B] when the examinee is a man, and the following formula [C] when the examinee is a woman. Thereby, the distance of the estimated height of the fifth intercostal space can be estimated more accurately depending on the gender.
D1 = [(H - 104.088) / 2.23] [B]
D1 = [(H - 83.113) / 2.76] [C]

In still another aspect of the present invention, in an electrocardiographic testing method with three leads, a circle with a radius of 5 cm or less centered at a position 7.5 to 15 cm downward from the center point P of the line segment, with the height being H. The inside is the first measurement electrode position, and the inside of the circle within a radius of 5 cm centered on the position vertically downward distance D2 from the first measurement electrode position is the second measurement electrode position, and H and D2 are the following equations. It is preferable that the electrocardiographic testing method is characterized by satisfying the relationship E. This makes it possible to accurately estimate the measurement electrode position for three leads, which is even more difficult than for one lead.
D2 = [(H - 119.390) / 2.47] ± 5.0 [E]

In still another aspect of the present invention, in an electrocardiographic testing method with three leads, a circle with a radius of 5 cm or less centered at a position 7.5 to 15 cm downward from the center point P of the line segment, with the height being H. The inner part is the first measurement electrode position, and the part within a circle with a radius of 5 cm centered on a position vertically downward from the first measurement electrode position D2 is the second measurement electrode position, and H and D2 are the second measurement electrode positions. It is preferable that the electrocardiographic examination method is characterized by satisfying the following formula [F] in the case of a male patient and the following formula [G] in the case of a female patient. Thereby, the distance of the estimated height of the fifth intercostal space can be estimated more accurately depending on the gender.
D2 = [(H - 126.388) / 2.23] ± 5.0 [F]
D2 = [(H - 110.713) / 2.76] ± 5.0 [G]

As yet another aspect of the present invention, it is preferable that the electrocardiographic examination method is characterized by including three leads: NASA lead, CM5 lead, and CC5 lead.

As yet another aspect of the present invention, it is preferable that the physique information further includes at least one of body weight, chest circumference, and abdominal circumference.

Still another aspect of the present invention is an electrocardiogram characterized in that the step (6) of starting the electrocardiogram measurement includes a step of informing the examinee whether the clothing and the measurement device are correctly worn. Preferably, it is a testing method.

Still another aspect of the present invention is characterized in that the step of informing the examinee whether or not the patient is wearing the device correctly uses at least one of vibration, light, and sound from the measurement device or a terminal that wirelessly communicates with the measurement device. More preferably, it is an electrocardiographic testing method. It is possible to make a decision by showing the electrocardiogram waveform to the patient, but it is a safer service for the patient to be informed of the information automatically determined by the system through a simple method such as vibration, light, or sound from a terminal. Become.

Still another aspect of the present invention is an electrocardiogram testing method, characterized in that acquired data is transmitted and recorded to a server directly from the measurement device or via a terminal that wirelessly communicates with the measurement device. is preferred. Even if the measuring device is lost during the delivery step between the patient and the service provider, there is no risk of leaking electrocardiogram data, which is personal information of the patient.

As yet another aspect of the present invention, it is also preferable that the electrocardiographic testing method is characterized in that the data acquired by the electrocardiographic measurement is recorded on a recording medium within a device. When transmitting data via wireless communication, there is a concern that data may be lost due to the communication environment, etc. Furthermore, since the data size of multi-lead electrocardiogram data is large, communication costs can be high. To prevent leakage of electrocardiographic data due to theft of a measuring device, etc., it is preferable to encrypt recorded data.

As still another aspect of the present invention, it is preferable that the electrocardiographic testing method is characterized in that the measuring device or a terminal that wirelessly communicates with the measuring device includes means for recording a predetermined event.

As yet another aspect of the present invention, it is preferable that the electrocardiographic testing method is characterized in that exercise data from at least one of an acceleration sensor and a gyro sensor is also recorded.

FIG. 1 is a flowchart showing the first embodiment of the electrocardiography method according to the present invention. Figure 2 is a system diagram used for the electrocardiogram shown in Figure 1. FIG. 3 is a flowchart showing a second embodiment of the electrocardiography method according to the present invention. FIG. 4 is a diagram showing the appearance of clothing 1 used in the electrocardiographic testing method according to the present invention. FIG. 5 is a diagram showing the appearance of another embodiment of clothing 1 used in the electrocardiographic testing method according to the present invention. FIG. 6 is a diagram showing the appearance of another embodiment of clothing 1 used in the electrocardiographic testing method according to the present invention. FIG. 7 is a diagram related to NASA lead of electrocardiogram measurement according to the present invention. FIG. 8 is a diagram regarding CM5 lead of electrocardiogram measurement according to the present invention. FIG. 9 is a diagram regarding the CC5 lead of electrocardiogram measurement according to the present invention. FIG. 10 is a flowchart showing the third embodiment of the electrocardiographic testing method according to the present invention. FIG. 11 is a block diagram of the measurement device 31 according to the present invention.

Hereinafter, preferred embodiments of the present invention will be described in accordance with the accompanying drawings.

FIG. 1 is a flowchart of the electrocardiographic testing method according to the present invention. For example, when the present invention is used for a service such as a health checkup, the testing service provider obtains physical information such as height and weight of the examinee in advance by having the examinee fill out an application form (step S1).

Next, the testing service provider selects the clothing size based on the physique information so that the measurement electrodes are placed at appropriate positions according to the physique of the patient (step S2).

Next, the testing service provider sends (hands over) the selected clothing, measurement electrodes, and measurement device to the patient (step S3). The information may be delivered by hand to the patient, or by mail or home delivery service, and from the viewpoint of convenience for the patient, it is preferable to send it to the patient's home by mail or home delivery service. The shipment may also include an instruction manual and, if necessary, additional disposable gel electrodes.

Next, the patient puts on the clothes himself and determines the electrode position (step S4). The clothing may have a mark or opening indicating the electrode position, or a mechanism such as a snap button for temporarily fixing the electrode position inside the clothing. The opening can be a through-hole formed in the clothing and has a size that allows the electrode to pass through. For example, the opening can be a circular through hole with a larger diameter than the electrode. Thereby, the patient can attach the electrode to an appropriate position on the body surface through the opening with adhesive, adhesive, etc., while wearing clothing. Furthermore, even if you take off your clothes after attaching the electrodes to your body, the electrodes remain attached to your body because they are attached directly to your body. The shape of the opening can be set as appropriate depending on the shape of the electrode.

Next, the patient places the measurement electrode at the electrode position determined in step S4 (step S5). In this step, only the electrodes may be arranged, or the measurement electrodes may be connected to the measurement device in advance and the entire measurement device may be arranged.

Next, the patient starts electrocardiogram measurement (step S6). Clothing is not required for electrocardiogram measurement, and patients may take off their clothing before electrocardiogram measurement. Electrocardiogram measurement is performed when the resistance between the measurement electrodes becomes finite, that is, when at least two measurement electrodes connected to the measurement device are placed on the body and the potential between the measurement electrodes can be measured. It may be started automatically, or it may be started intentionally by the patient turning on a switch or the like. Alternatively, the measurement device may be paired with an information processing terminal such as a smartphone using Bluetooth or the like, and the measurement may be started using a smartphone application installed on the information processing terminal. In this case, it is a disadvantage that electrocardiogram measurement cannot be performed because the examinee does not have an information processing terminal such as a smartphone or tablet terminal, so it is preferable that the electrocardiogram can be measured without an information processing terminal such as a smartphone.

FIG. 2 shows a system used in the electrocardiographic testing method shown in FIG. 1 according to the present invention, that is, clothing 1, measurement electrodes 2, and measurement device 3. Clothes 1 of the size determined in step S1 are sent to the patient. Although there are three measurement electrodes 2 in FIG. 2, the number of measurement electrodes required may be determined depending on the number of leads, the presence or absence of a neutral electrode, or the necessity of a spare measurement electrode. Usually, one measuring device 3 is sufficient, but a plurality of measuring devices 3 may be used for long-term measurement exceeding the battery life. In conventional electrocardiogram tests, medical personnel wear the device and the patient cannot replace it, but with the present invention, the patient can wear it himself, making it possible to replace such a measuring device.

FIG. 3 is a flowchart showing a second embodiment of the electrocardiography method according to the present invention. After electrocardiogram measurement is started in step S6 of FIG. 1, the patient returns the measurement device to the service provider after the measurement is completed (step S7). Clothing may also be returned if necessary. It is preferable to send return packaging materials, return address documents, etc. together with the package when sending in step S3, since this will reduce the burden on the patient.

Next, the service provider analyzes the electrocardiographic data of the patient, outputs the electrocardiographic test results, and reports the result to the patient (step S8). The results may be electronic data such as PDF, or may be printed on paper.

Next, the service provider checks the operation of the clothing and measuring device (step S9). This step does not need to be performed every time for all devices depending on the operating method, but measurement devices always need to be charged. Note that as long as it comes after step S7, it does not matter which step comes first depending on the operating method.

FIG. 4 is a diagram showing the appearance of clothing 1 used in the electrocardiographic testing method according to the present invention. Since the clothing 1 is worn directly on the bare skin, it is preferably a short-sleeved T-shirt type or a sleeveless type that is easy to wear as underwear regardless of the season. Clothes 1 has a neckline that passes through the neck, and a straight line connects the left and right vertices 11 of the neckline that occur when the front and back sides are put together, and the distance is vertically downward from the center point 12 of the line segment (point P in the figure). The assumed height 13 of the fifth intercostal space of the patient is located at position D1. FIG. 4 shows an example of one-lead electrocardiogram measurement. The area within a circle within a radius of 5 cm around this position is the lower measurement electrode position 151, and the area within a circle within a radius of 5 cm around a position 8 to 15 cm upward from the lower measurement electrode position is the upper measurement electrode position 152. .

The following relational expression exists between the distance D1 indicated by reference numeral 14 in FIG. 4 and the height H of the patient.

(If there is no gender information)
D1 = [(H - 94.690) / 2.47] [A]
(For men)
D1 = [(H - 104.088) / 2.23] [B]
(For women)
D1 = [(H - 83.113) / 2.76] [C]

Regarding the distance of the assumed height of the fifth intercostal space of the human body, see, for example, Yonguc, G. N. , et al. “Estimation of statue and sex from internal lengths: an automation study.” Anatomical science international 90.2 (2015): 89-96. A high correlation between height and sternum length has been shown. The sternum consists of the manubrium, the body of the sternum, and the xiphoid process. Since the distance from point P to the manubrium of the sternum is approximately 10 cm, D1 corresponds to the sum of this 10 cm, the manubrium of the sternum, and the body of the sternum. Table 2 shows the relationship between the height of men and women and the lengths of the manubrium and body of the sternum. In the present invention, when gender is not taken into consideration, the above-mentioned formula [A], which is an average of formula [B] and formula [C], is used, and it has been found that it still shows sufficient accuracy.

FIG. 5 is a diagram showing the appearance of another embodiment of clothing 1 used in the electrocardiographic testing method according to the present invention. Unlike FIG. 4, in FIG. 5, a range 15 including a plurality of electrode positions is set as the measurement electrode position. In electrocardiometry, there are cases in which electrodes are connected to a measurement device and placed on the body, and in that case, the position of the measurement electrode is essentially determined by indicating the position that matches the shape of the measurement device. be able to.

FIG. 6 is a diagram showing the appearance of another embodiment of clothing 1 used in the electrocardiographic testing method according to the present invention. Clothes 1 has a neckline that passes through the neck, and extends vertically downward 7. The first measurement electrode position 153 is located within a circle within a radius of 5 cm around a position of 5 to 15 cm, and the assumed height of the fifth intercostal space of the patient is located at a distance D2 vertically downward from the first measurement electrode position 153. . FIG. 6 shows an example of three-lead electrocardiogram measurement. The second measurement electrode position 154 is within a circle within a radius of 5 cm around this position. Furthermore, for three-lead electrocardiogram measurement, it is preferable to arrange two measurement electrodes 15 in total, one on each side of the electrode 154. The measurement electrode positions may span a plurality of locations, or a plurality of measurement electrode positions may be grouped together as in FIG. 5 .

As shown in Figure 6, three measurement electrodes are placed on the virtual line of the assumed height 13 of the fifth intercostal space, and NASA lead, CM5 lead, and CC5 lead are measured using four electrodes including the first measurement electrode. Electrocardiogram measurement using three leads is called an EASI-lead electrocardiogram, and as an alternative to the most detailed 12-lead electrocardiogram, for example, "Deriving the 12-lead electrocardiogram from four (EASI)" by Dower et al. es.” Journal of electrocardiology 21 ( 1988): S182-S187. This is a method that has been known for a long time. As an advantage of the EASI-derived electrocardiogram, for example, Finlay et al.'s “Effects of electrode placement errors in the EASI-derived 12-lead electrocardiogram” am.” Journal of electrocardiology 43.6 (2010): 606-611. As shown in , it is known that an error of ±5 cm in the vertical and horizontal directions from the ideal measurement electrode position is allowed. The inventors used apparel pattern technology to place electrocardiogram measurement electrodes on the left and right sides of the neckline in order to be able to place electrocardiogram measurement electrodes with an accuracy of within ±5 cm relative to this anatomical marker position by simply wearing the clothing. It has been found that it is effective to determine the position of the first electrode 153 (measurement electrode) with reference to the vertex 11.

Furthermore, it is preferable to arrange a neutral electrode 150 on the clothing 1 in order to reduce electrocardiogram noise and stabilize the baseline. The location of the neutral electrode 150 is not particularly limited as long as it does not affect the measurement, but in the case of a shirt, it is limited to the upper body, so the wrist or right side abdomen is preferable, and the right side abdomen is particularly preferable since it can be done even with short sleeves. .

FIG. 7 is a diagram regarding NASA lead of electrocardiogram measurement according to the present invention.

FIG. 8 is a diagram regarding the CM5 lead of electrocardiogram measurement according to the present invention.

FIG. 9 is a diagram regarding the CC5 lead of electrocardiogram measurement according to the present invention.

FIG. 10 is a flowchart showing the third embodiment of the electrocardiographic testing method according to the present invention. Instead of step S6 in FIG. 3, it is checked whether the measurement electrodes are correctly attached based on the electrocardiogram data obtained after the start of measurement, and if not, the patient is informed and the patient re-wears his/her clothing. There are no particular limitations on the method of notification, but from the viewpoint of convenience and an intuitive user interface, it is preferable to notify the patient using a method such as vibration of the device, light, or sound.

FIG. 11 is a block diagram of the measurement device 31 according to the present invention. Measurement, event input, etc. are performed mainly using the main control unit 311. An event is when a patient feels abnormal in physical condition during 24-hour electrocardiogram measurement, including palpitations, shortness of breath, dizziness, heart pain, etc. This makes it possible to analyze the relationship between the abnormality felt by the patient and the electrocardiogram at that time. A power source 312 supplies power not only to the main control section but also to each section. The AD converter 313 is for digitally converting the potential between a pair of measurement electrodes, and preferably uses an amplifier to amplify the potential. The sampling frequency for electrocardiogram measurement is preferably 100 Hz or more, more preferably 250 Hz or more, particularly preferably 500 Hz or more, and most preferably 1000 Hz or more.

Recently, AD converters for measuring biopotentials such as electrocardiograms have also appeared. Many of these AD converters preferably include a circuit called RLD (Right Leg Drive) for connecting a neutral electrode as a ground for removing noise from household power supplies, radio waves, etc. Regarding RLD, for example, Winter et al., “Driven-right-leg circuit design.” IEEE Transactions on Biomedical Engineering 1 (1983): 62-66. is shown. There are no particular limitations on the neutral electrode as long as it is designed to determine the ground of the biological potential on the circuit within the device, even if it is not an RLD.

In recent years, a technique called Heart Rate Variability (HRV), which measures fluctuations in the time interval of R waves, has been used to monitor the autonomic nervous system, such as stress, using electrocardiometry. Although time accuracy is important in this method, the built-in clock of commercially available microcontrollers is easily affected by environmental temperature, so it is recommended to use a more accurate real-time clock (RTC) 314 for the measurement device 31. preferable.

It is preferable that the measurement device 31 according to the present invention includes an information output section 32 in order to inform the patient of whether the measurement electrode is correctly attached as described above. As the information output section, it is more preferable to use vibration from the vibration motor 321, light from the LED 322, and sound from the speaker 323. There are no particular limitations on how to determine whether the electrodes are correctly attached, but for example, if one or both of the pair of measurement electrodes is removed, only a large noise signal will be produced, so measure the S/N ratio in a certain section. In addition to the method of determining the heartbeat using Fourier transform, it is preferable to use a method of detecting the period of the heartbeat by Fourier transform, or a method of detecting using a low-pass filter that emphasizes the R wave of the electrocardiogram. The information output unit 32 outputs at least one of vibration, light, and sound when it is determined by the above method that the measurement electrode is correctly attached, or when it is determined that the measurement electrode is not attached correctly.

Furthermore, it is preferable that the measuring device 31 according to the present invention includes an information input section 33 for recording predetermined subjective symptoms and recording actions. As the information input unit 33, it is more preferable that there is an event button 331 that the patient actively inputs, and it is particularly preferable that the patient's exercise information is automatically recorded by the inertial sensor 332 without the patient being aware of it. . In this way, the measuring device 31 or a terminal that wirelessly communicates with the measuring device 31 may be provided with means for recording predetermined events.

Further, the measurement device 31 according to the present invention includes a recording unit 34 (recording medium) for recording not only electrocardiograms but also events and information (data) of the inertial sensor. It is preferable to use memory 341 for data recording. Alternatively, it is possible to transmit the information via the wireless module 342 to an external device such as a smartphone or PC, or directly to the Internet, which is preferable. The data acquired by electrocardiogram measurement may be transmitted to the server and recorded directly from the measurement device 31 or via a terminal that wirelessly communicates with the measurement device. In the case of a 24-hour electrocardiogram, it is more preferable to record the electrocardiogram in the memory 341 within the measurement device 31, since the examinee travels and may not have an Internet environment or may not carry a smartphone.

As the electrodes (measuring electrodes, neutral electrodes) used for electrocardiogram measurement according to the present invention, in addition to general gel electrodes, rubber electrodes made of conductive rubber or cloth electrodes made of conductive cloth can be used. Since the electrocardiogram measurement of the present invention is aimed at high-precision measurement for medical purposes, it is preferable to use a sticky gel electrode that is not easily affected by body movements such as walking. Gel electrodes are generally disposable and attached with snap buttons.

Table 1 shows the actual size of D2 and the recommended height for examinees for each gender when the clothing of the present invention is manufactured in five sizes: XS, S, M, L, and XL.

For clothing in Table 1, calculate formula [E] for unisex clothing, formula [F] for men, and formula [G] for women for patients with a height of 147 cm to 190 cm. Table 2 shows the results of calculating the upper and lower limits of D2 and verifying their correspondence with the recommended size. The sizes corresponding to the D2 range obtained from the formula include the sizes obtained from the recommended size chart based on the patient's height, and it was confirmed that electrocardiograms could be measured without any problems.

Table 3 shows the electrocardiogram measuring shirt of the present invention, which is available in five sizes: This shows the recommended height, chest circumference, and waist measurement for patients by gender. In the present invention, as shown in Table 2, it is possible to select multiple clothing sizes that can be worn by people of the same height, but it is also possible to adjust the size within the allowable size by taking into account chest circumference, waist, weight, etc. .

Furthermore, it goes without saying that the present invention is not limited to the embodiments described above, and that various modifications can be made without departing from the spirit of the present invention.

S1 to S61 Step 1 Clothes 2 Measuring electrode 3 Measuring device 4 Patient 11 Vertex of neckline 12 Center point P of vertex of neckline
13 Estimated height of the 5th intercostal space 14 Distance D between point P and the estimated height of the 5th intercostal space
15 Measurement electrode position 150 Neutral electrode position 151 Lower measurement electrode position 152 Upper measurement electrode position 153 First measurement electrode position 154 Second measurement electrode position 16 Distance between the first measurement electrode position and the assumed height of the fifth intercostal space D
31 Measuring device 32 Information output unit 33 Information input unit 34 Recording unit 311 Main control unit 312 Power supply 313 AD converter 314 Real-time clock 321 Vibration motor 322 LED
323 Speaker 331 Event button 332 Inertial sensor 341 Memory 342 Wireless module

Claims (17)

In an electrocardiographic testing method using clothing, measurement electrodes, and a measurement device, (1) obtaining physique information of the examinee; and (2) selecting a size from among at least two different sizes according to the physique information of the examinee. Step of selecting the clothing size (3) Handing the selected clothing, measurement electrode, and measurement device to the patient (4) Step of allowing the patient to decide the electrode position by themselves using the clothing (5) Determined A step (6) of the examinee placing the measurement electrode at the electrode position by himself/herself (6) and a step of starting electrocardiogram measurement is provided, and the appropriate electrode position for the electrocardiogram is indicated on the clothing. An electrocardiogram testing method, characterized in that the clothing does not have a function of acquiring or transmitting electrocardiographic signals, and that electrocardiogram measurement can be performed using the measurement electrode and the measurement device even without the clothing. After the step (6) is completed, (7) the patient returns the measuring device, (8) reports the electrocardiogram results to the patient, and (9) checks the operation of the measuring device. The electrocardiographic testing method according to claim 1, further comprising the step of: The electrocardiographic testing method according to claim 1 or 2, wherein the clothing has an opening at the electrode position. The electrocardiographic testing method according to claim 1 or 2, further comprising a mechanism that can fix the measurement electrode at the electrode position inside the clothing. The electrocardiographic testing method according to any one of claims 1 to 4, wherein the physique information includes height. In the electrocardiographic testing method in which the number of leads is 1, the clothing has a neckline surrounding the neck, and the height according to claim 5 is H (cm),
The lower electrode position is within a circle within a radius of 5 cm centered on a position a distance D1 (cm) vertically downward from the center point P of the line segment connecting the left and right vertices of the left and right necklines with a straight line, and the vertical line from the lower electrode position The upper electrode position is within a circle with a radius of 5 cm centered on a position 8 to 15 cm above,
6. The electrocardiographic testing method according to claim 5, wherein H and D1 satisfy the following equation [A].
D1 = [(H - 94.690) / 2.47] [A] In an electrocardiographic testing method having one lead, the clothing has a neckline surrounding the neck, and the height according to claim 5 is H (cm),
The area within a circle within a radius of 5 cm centered on a position vertically downward from the center point P of the line segment connecting the left and right vertices of the left and right necklines with a straight line, D1 (cm), is the lower measurement electrode position, from the lower electrode position. The upper measurement electrode position is within a circle with a radius of 5 cm centered on a position 8 to 15 cm vertically upward, and H and D1 are expressed by the following formula [B] when the patient is male, and when the patient is female. The electrocardiographic testing method according to claim 5, characterized in that the following equation [C] is satisfied.
D1 = [(H - 104.088) / 2.23] [B]
D 1= [(H - 83.113) / 2.76] [C] In an electrocardiographic testing method with three leads, the clothing has a neckline surrounding the neck, and the height according to claim 5 is H (cm),
The first measurement electrode position is within a circle within a radius of 5 cm centered at a position 7.5 to 15 cm downward from the center point P of the line segment connecting the left and right vertices of the neckline with a straight line;
The second measurement electrode position is within a circle with a radius of 5 cm centered around a position vertically downward distance D2 (cm) from the first measurement electrode position, and H and D2 satisfy the relationship of formula E below. The electrocardiographic testing method according to claim 5, characterized in that:
D2 = [(H - 119.390) / 2.47] ± 5.0 [E] In an electrocardiographic testing method with a number of leads of 3, the clothing has a neckline surrounding the neck, and the height according to claim 5 is H (cm),
The first measurement electrode position is within a circle within a radius of 5 cm centered at a position 7.5 to 15 cm downward from the center point P of a line segment connecting the left and right vertices of the neckline with a straight line. The second measurement electrode position is within a circle with a radius of 5 cm centered on a position vertically downward from the position D2 (cm), and when H and D2 are male patients, the following formula [F], 6. The electrocardiographic testing method according to claim 5, wherein the following formula [G] is satisfied when the subject is female.
D2 = [(H - 126.388) / 2.23] ± 5.0 [F]
D2 = [(H - 110.713) / 2.76] ± 5.0 [G] The electrocardiographic testing method according to claims 8 to 9, wherein the leads according to claim 8 include three leads: a NASA lead, a CM5 lead, and a CC5 lead. The electrocardiographic testing method according to any one of claims 5 to 10, wherein the physique information further includes at least one of body weight, chest circumference, and abdominal circumference. Claims 1 to 3, wherein the step of starting electrocardiogram measurement according to (6) of claim 1 includes a step of notifying the patient whether or not the clothing and the measurement device are correctly worn. 11. The electrocardiographic testing method according to any one of 11. The step of notifying the patient whether or not the device is correctly worn is characterized by notifying the patient using at least one of vibration, light, and sound from the measuring device or a terminal that wirelessly communicates with the measuring device. The electrocardiographic testing method according to claim 12. According to any one of claims 1 to 13, wherein the data acquired by the electrocardiogram measurement is transmitted to a server and recorded directly from the measurement device or via a terminal that wirelessly communicates with the measurement device. Electrocardiography method. The electrocardiographic testing method according to any one of claims 1 to 13, wherein the data acquired by the electrocardiographic measurement is recorded on a recording medium within a device. The electrocardiographic testing method according to any one of claims 1 to 15, wherein the measuring device or a terminal that wirelessly communicates with the measuring device includes means for recording a predetermined event. The electrocardiographic testing method according to any one of claims 1 to 16, characterized in that exercise data acquired by at least one of an acceleration sensor and a gyro sensor is also recorded.

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