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32MODERN MOBILE MEDICINE TECHNOLOGIES OF IDENTIFYING
CARDIOVASCULAR DISEASES
Bogomolov A.I., Ph. D., associate Professor
Financial University under the Government of the Russian Federation, Moscow, Russia
E-mail: AIBogomolov@fa.ru
Nevezhin V. P., Ph. D., Professor
Financial University under the Government of the Russian Federation, Moscow, Russia
E-mail: VPNevezhin@fa.ru
Abstract. The article is devoted to the review of foreign technologies of identifying precursors of the crisis of the cardiovascular system. A brief description of the various medical databases that can be used for research is given. The scientific articles and publications related to this problem and of interest to domestic colleagues are reviewed. Special attention is paid to medical information resources that are convenient in terms of finding contacts and partners, and technological solutions in the field of mobile medicine of some foreign companies. The necessity and relevance of the application of different approaches to the development of mobile medicine technologies focused on cardiovascular diseases, and the use of materials for this purpose in existing patents are substantiated.
Key words: cardiovascular system, mobile health, electrocardiogram, monitoring of cardiac activity, a disease database, an electrode, a heart rate monitor, patents.
1. Introduction
Today cardiovascular diseases are one of the main causes of death in the world: for no other reason as many people die each year as from this type of disease. As assessed by the World Health Organization, in 2016 17.9 million people died because of heart problems, which accounted for 31% of all deaths in the world. Most cardiovascular diseases can be prevented by taking actions against risk factors such as tobacco use, unhealthy diet and obesity, physical inactivity and excessive alcohol consumption.
However, even the absence of bad habits cannot protect a person from the possible appearance of heart problems. In such cases, the earlier the disease is detected, the greater the chance that a person can effectively get rid of it. Unfortunately, it is not always possible to identify in advance emerging problems with the cardiovascular system.
Here various technologies can help to identify the harbingers of a cardiovascular crisis. One of these technologies is mobile medicine. This is a relatively new direction, combining the achievements of medicine, big data and mobile communications. Mobile medicine allows you to monitor your health in real time. While a person goes to the hospital for an examination, at best, once every six months, mobile medicine allows a person to perform such
examination independently on a daily basis, wherever he is.
It is necessary to recognize that the foreign community is ahead of the Russian one in this direction. Mobile medicine is actively developing in advanced countries with a high standard of living. This is not surprising, given the expenditure volume of advanced economies on health care. Annually, the figures for medical expenses in these countries are close to 10% of GDP, while in Russia this figure is less than 4% of GDP. Below is a diagram of public health expenditures of various countries for 2016 (Table 1).
Table 1. Public health expenditures in 2016, % of GDP
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Public health expenditures in 2016 , % of GDP
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_op £ £
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Over the past 5 years, a number of portable devices has been released in Western countries that can monitor the heart condition and detect the precursors of a cardiovascular crisis during work, stroll, rest, etc. Many of them have already been recognized as reliable medical devices that allow
5
0
obtaining a true diagnosis of the disease. This is the case for Apple Watch 4 smart watch, which the FDA (US Food and Drug Administration) allowed to sell as a medical device. The Russian Ministry of Health has not yet given the permission to use such devices.
2. Medical databases
The development of new medical technologies always requires long-term research. To identify the harbingers of the crisis of the cardiovascular system, a large initial database with records of electrocardiograms of various people is needed. While in the Russian Internet network there are very few such databases in the public domain, the foreign community has made great strides in this regard. There are many different Internet resources related to the measurements of physiological signals. Let us highlight, in our opinion, the most interesting ECG bases.
The site of Physionet [1] is a huge research resource for complex physiological signals. It was created with the support of the National Institute of General Medical Sciences (NIGMS, USA) and the National Institute of Biomedical Imaging and Bioengineering (NIBIB, USA). This resource is presented in the following sections: PhysioNet Library, PhysioBank, PhysioToolkit and PhysioNetWorks.
The PhysioNet Library section contains information on publications in English on medical topics.
The PhysioBank section is currently a large and growing archive of information and records related to human physiological processes. It contains more than 90,000 records, or more than 4 terabytes of digitized physiological signals and time series, organized in over 80 databases. There are ECG databases, each of which differs in some parameters, such as the number of measurements, length, time, etc. For example, the PTB Diagnostic ECG Database [2] contains 549 records of 290 patients aged from 17 to 87 years, including 209 men and 81 women. Each record consists of 15 simultaneously measured signals.
The PhysioToolkit section presents a software library for processing and analyzing physiological signals, detecting physiologically significant events
using both classical methods and new methods based on statistical physics and nonlinear dynamics.
Specialists from the South Korean School of Medicine at Ajou University have created a website containing information based on their own ECG database [3]. In general, the research database contains observational data on the proarrhythmic potential of advertised drugs, including more than 700,000 measurements and related clinical data, including diagnoses, information on prescribed drugs, and laboratory results. These data were obtained from 461 thousand patients aged from 23 to 61 years over the 19-year study period.
In order to get access to this database, a potential user needs to perform a series of actions. First, you need to send a request for permission. After that, the user receives an identification number, which he enters in the agreement. The agreement must be scanned and sent to the specified address. After that a link for the access will come.
The Medical Center at the University of Rochester (USA) on its website also has a number of ECG databases [4], which differ in the parameters studied. For example, there is a database containing 689 records from 689 people, the other database contains 5232 records, but only from 22 people. Currently, 13 ECG databases are available for users of the site, but in order to become a new user, you need to fill in some agreements.
One Russian Internet resource should also be mentioned. The Department of Higher Nervous Activity of the Biological Faculty of Moscow State University has its own website [5], where you can get acquainted with the library of physiological records, including records of electrocardiograms and electroencephalograms. The ECG-sport database contains 380 text files of cardiointervals in milliseconds of highly qualified athletes (candidates for master of sports, master of sports) in 5 kinds of sports: hockey, football, basketball, short track, judo. Records were made and compiled by famous sports methodologist Vyacheslav Zaitsev in 1998-2002. This base can be used as a standard of cardiac activity in a high-energy state of body, in comparative scientific research and for educational purposes.
Records of this database have been used in a variety of medical studies.
3. Articles and publications
To implement the domestic project of creating a device for identifying the harbingers of the cardiovascular system crisis, you need to be able to use the practices of foreign colleagues. In the Internet community there are many sources of articles and publications, somehow connected with the topic of electrocardiography.
One of the holders of such sources is the National Metrological Institute of Germany [6], whose mission is to provide scientific and technical services. On its website, there is a separate section for searching publications and scientific works and, in particular, there are many scientific publications on the topic of ECG.
The Journal of Electrocardiology (Netherlands) is the official journal of the International Community of Computerized Electrocardiology and the International Community of Electrocardiology [7]. It is devoted exclusively to clinical and experimental studies of the heart electrical activity. The journal seeks to contribute to the accuracy of diagnoses and prognoses, and to effective treatment, prevention, or delay of heart disease. There are many articles on ECG in the issues of the journal. However, to access them, you must be a registered user.
There is an interesting scientific work of German specialists from the Technical University of Berlin, devoted to computer models of electrical excitation of the human heart [8]. There are huge amounts of mathematical models and formulas associated with the heart activity. This publication needs to be studied by domestic scientists, not only in the field of medicine. It is worth noting that the work was written based on the 109 sources that are listed in the article, which themselves may be useful for potential researchers.
Also, the Technical University of Berlin has its own online resource for searching publications -Deposit Once [9]. If you type "ECG" in the search field, the site presents a number of interesting articles, for example, an article about algorithms used for ECG analysis [10], written by Reinhold Orglmeister [11] and Maik Pflugradt [12]. In this
work, there are various calculation formulas and mathematical models that can be useful both for Russian developers and researchers in other countries.
The previously mentioned author Reinhold Orglmeister is also a co-author of the article "Principles of software detection of QRS" [13], which contains algorithms for detecting the waveform from an electrocardiogram (Fig. 1). The material presented in the article, including formulas, drawings and diagrams, can be used in scientific developments.
Fig. 1. Fragment of the article "Principles of software detection of QRS" Attention should also be paid to the online library of the California University of Science and Medicine (USA) [14], in which there are many works related to electrocardiography. On the website of this library, there is access for registered users to many medical databases [15].
Finally, on the Internet, you can find a site called MDPI [16], the developers of which call him a pioneer in the open publication of scientific materials, emphasizing that it has supported academic communities since 1996. The site shows that the headquarters of the MDPI is located in Basel (Switzerland), and there are offices in a number of cities in Europe and China. The mission of MDPI is to promote an open scientific exchange in all its forms and among all disciplines. It should be particularly noted that this resource is the most convenient in finding contacts and partners, since the mailboxes of the authors are enclosed to each publication.
4. Mobile medical device developers and their products
In the last 5-7 years the market of portable electronics has been literally flooded by various fitness devices (watches, bracelets, trackers) and heart rate monitors, offering the possibility of synchronizing your pulse data with a smartphone. However, it happens that just the information from the heart rate monitor is not enough and more detailed data on the heart activity is needed, especially when there are problems with it.
This is where mobile medical devices developed by the American company AliveCor (USA) [17] can come to the rescue. The company offers simple and innovative devices for taking an electrocardiogram and getting a diagnosis directly on iOS or Android gadgets in just 30 seconds. Its devices have passed clinical trials and have been approved by the FDA (Food and Drug Administration) and have received certification in the European Union. It is worth noting that the expert community praised these new products. Therefore, we dwell on these devices in more detail.
The first of these devices is called KardiaMobile. It is a small plate, on the front of which there is a pair of electrodes responsible for monitoring cardiac activity. Information is not transmitted via Bluetooth, but through ultrasonic waves that are captured by the microphone of the smartphone. This communication method makes it much easier to use the device and saves the energy use of a mobile phone. According to the manufacturer, it uses the usual removable lithium battery, which many watches are powered on, and it holds a charge for an average of two years.
The Kardia Mobile device is also very convenient because it easily fits in your pocket, since its dimensions are about the size of two outstretched fingers (see Fig. 2). There is a special clip that can be attached to the back of the phone and KardiaMobile plate can be inserted into it. This allows you to carry the device with your phone. AliveCor also offers an iPhone 7/8 case, which already contains a plate inside. This is convenient, since it is hard to lose the plate (see Fig. 3.).
Fig. 3. The clip for KardiaMobile and the iPhone case
Full support of all the available services of this project is not provided in all countries, but only in the USA, Canada, United Kingdom and in a number of other advanced economies. Let's look at how people can use the services of KardiaMobile in the United States. First of all, you need to install a special program AliveCor on your smartphone. Further, it is launched, while the smartphone is in a horizontal position, and then you put your fingers on the electrodes. The program automatically begins to take data, after which it immediately gives a brief conclusion. In manual order, you can add symptoms (insomnia, anxiety, dizziness, etc.), recent activity or a short note. All this information through an existing application can be sent for verification to a US certified cardiologist. But this is a paid option. For $ 5 the data will first be sent to the laboratory doctor, who will give a preliminary assessment of the state of health without issuing recommendations and will do its job in half an hour (or within a day if you pay only $ 2). For $ 12 an ECG will be checked by a certified medical doctor with experience of at least twelve years and will write out recommendations. It is also possible to print an ECG, send it by e-mail to your doctor or save it in PDF format. The program can store data of several people.
The second product of AliveCor is the KardiaBand strap for Apple Watch. It is convenient for the fact that the electrode is already built into the strap, and that it constantly remains on hand. At the moment when you need to record the ECG, you simply put your finger on the pad and hold it for 30 seconds. The cardiograph works in conjunction with an application that allows you to monitor the heart activity and may notice deviations from the norm. In such cases, the application signals the user, and he can send the cardiogram to the doctor for professional evaluation.
AliveCor's KardiaBand strap was certified by the US Food and Drug Administration (FDA) as early as
2017, and it became the first AppleWatch accessory for smart watches to be recognized as a medical device. At the same time, the heart rate sensor at that time had already been in the smartwatch, but Apple did not have an FDA license. And only in September
2018, with the release of the Apple Watch Series 4, it became known that the new model would be able to
record an electrocardiogram. The FDA certified Apple's smart watch as an ECG device for the first time in history. The new generation of this watch analyzes the activity of the heart precisely enough to detect atrial fibrillation (one of the most common types of arrhythmias). However, to record cardiogram using the fourth-generation of Apple Watch, you need a special application that the manufacturer promised to release before the end of 2018. Unfortunately, only residents of the United States will be able to use this feature, as Apple has not yet received certification for its device in other countries. It should be noted that AliveCor, compared with other companies that develop mobile medical devices and applications, currently has a number of advantages, including the fact that its ECG services are available in a lot of countries around the world. On the other hand, the use of AliveCor products will be more expensive for users, since KardiaMobile / KardiaBand are expensive, and, moreover, the use of KardiaBand implies a mandatory paid subscription.
To sum up, it is worth saying that the AliveCor devices, of course, will not replace a doctor, which the company itself honestly warns, but they will greatly simplify the lives of those who have problems with their heart. For people who are distant from medical terminology, the application will explain in simple words what exactly is wrong with their heart and warn about the need to see a doctor immediately. In addition, the personal cardiologist will have access to all recorded data so that he can monitor the patient's condition.
The company called Qardio (USA) [18] offers technological solutions. It has a line of three products: smart wireless scales, a smart portable blood pressure monitor and a QardioCore heart monitor. Let's look at the latter in more detail.
QardioCore is the world's first wearable heart monitor, for which no wires or suction cups are needed. It is secured directly to the chest with a comfortable QardioCore strap. One of the advantages of this heart monitor is that it does not interrupt your daily activities: you can sleep with it and even play sports. While you are going to work, walking, or doing active procedures, QardioCore counts your steps and distance, determines calories burned,
monitors breathing and heart rate, and also records an electrocardiogram.
The QardioCore heart monitor looks quite futuristic: the device consists of two small white plates that are interconnected in the shape of an "X" (Fig. 4). The size of the heart monitor allows you to wear it under clothes without being noticed: it will not "stick out" under your shirt. The case is made of hypoallergenic and environmentally friendly materials, and it also has protection against water according to IP65 standard - not afraid not only of perspiration, but also of being in water.
Fig. 4. Cardiomonitor QardioCore For the most accurate measurement, the QardioCore heart monitor is fixed in a specific place on the chest, and an adjustable elastic strap allows people with different physiques to wear the gadget. During the day, the device measures not only the ECG, but also the heart rate (including variability), skin temperature, and also, monitors the physical activity of a person. You can track your measurements in the Qardio app for iPhone (compatible with iOS 9 and newer). At the end of each day, the data is automatically downloaded to this application and to the Health program in iOS, and also, in case of unforeseen situations are transferred to the cloud and stored there. The application is very easy to use: you can monitor the cardiogram in real time and monitor the pulse, respiratory rate and other indicators. All records are stored in the application, and the measurements data from other Qardio devices also goes there.
Using the export feature of the application, you can instantly send data to your doctor so that he can diagnose and prescribe proper treatment. QardioCore will be a great helper for people who care about their health, as well as for professional athletes, helping them to train competently. It is worth noting that the gadget is not cheap, but it is extremely useful for controlling your health condition.
5. Patents
When it comes to technology, patents play an important role, because they, to some extent, are the legal basis of inventions. It is wise to consider existing foreign patents on the topic we are studying, since they can be effectively used in the medical field.
Let's consider the patents of AliveCor. All patents were filed by David Albert, co-founder of the company. He also occupies the position of chief medical officer in AliveCor [19]. He filed a huge number of patents, many of which were granted, the rest are still pending.
The first of the patents is "Discordance monitoring" [20]. The inventions described therein are systems, devices, and methods for monitoring the heart. In particular, the systems, devices, and methods described therein can be used to conveniently determine the presence of intermittent arrhythmias in an individual, and they are configured to read the electrocardiogram. Heart monitoring devices mentioned in the patent may contain portable computing devices, such as smartphones, laptops, and tablet computers. Cardiac monitoring with their use can be used to predict or identify the occurrence of arrhythmias.
The patent describes methods for monitoring cardiac activity. They include: determining the level of human activity by the first sensor of a wearable device; reading the heart rate index by the second sensor; determining the value of heart rate variability by the processor of the specified wearable device; the determination by the above-mentioned processor of a discordance between the level of activity, the level of the heart rhythm and the value of the variability of the heart rhythm; warning the person of existing dissonance, if any.
Another patent is "Mobile ECG sensor apparatus" which is currently pending [21]. Its description states that the systems mentioned include mobile ECG sensors, systems and methods. One of the versions is an ECG sensor the size of a credit card, which allows the user to use two isolated electrodes to measure electrical signals of the heart.
The concept presented in this invention describes a personal monitoring device, methods and systems for measuring physiological signals and transmitting their results using wirelessly and soundlessly using ultrasonic signals with an improved signal-to-noise ratio (compared to traditional transtelephonic methods). It also describes the methods and algorithms for receiving and demodulating ultrasonic signals with high accuracy, using existing technologies for computers and smartphones.
The third patent, "Methods and systems for arrhythmia tracking and scoring" [22], suggests that some instrument panel will focus on the detection of arrhythmias and atrial fibrillation. It will perform the following function: assessment of the state of the heart, which is conducted according to the principle of points gained (with the improvement of the state, the user's health score improves and vice versa). The user's heart condition with such a panel can be calculated according to the information received, such as an ECG and other personal information, as well as factors affecting the healthy functioning of the heart. The device also provides the user with daily recommendations or targets for implementation, and thus they can help improve heart health score. These goals and recommendations can be set by both the user and the doctor, and can be updated as the user's heart score improves or changes. This toolbar is displayed in the app on your smartphone or tablet.
In the description of the patent the system is called the control system for heart disease and / or heart rhythm. It involves the interaction of the software part, which was described above, with the instrument part. Such a device could be a bracelet or any other device with electrodes that is capable of measuring heart activity. All data is uploaded to a remote server, where one or several experts analyze and provide ECG decoding, make diagnoses, give recommendations and set goals.
6. Conclusion
The information presented and the approaches considered may be of some interest and value both for Russian developers of similar technologies and for investors who are oriented to invest in Russian medical projects. At all times, it has always been easier to make a product based on another invention, rather than inventing and creating from scratch something new. The purpose of this article is to push people to develop domestic analogues of mobile medicine. Most of the information that can be used for this is collected, analyzed and presented because of a number of primary sources, a number of which is listed below. The interested parties can read them in more detail.
References
[1] https://www.physionet.org (Date: 5.12.2018)
[2] https://www.physionet.org/physiobank/database/ptbdb/ (Date: 5.12.2018)
[3] http://www.ecgview.org/ (Date: 7.12.2018)
[4] http://thew-project.org/ (Date: 4.12.2018)
[5] https://neurobiology.ru/ (Date: 5.12.2018)
[6] https://www.ptb.de/cms/en.html (Date: 6.12.2018)
[7] https://www.jecgonline.com/ (Date: 5.12.2018)
[8] Stefan Fruhner, "Realistic models of the electrical excitation in the human heart and the determination of the cardiac magnetic field". (Date: 7.12.2018)
[9] https://depositonce.tu-berlin.de/ (Date: 5.12.2018)
[10] https://depositonce.tu-berlin.de/bitstream/11303/7195/1/ bmt-2012-0026.pdf (Date: 5.12.2018)
[11] Reinhold.Orglmeister@tu-berlin.de
[12] Maik.Pflugradt@googlemail.com
[13] http://www.sm.luth.se/csee/courses/sms/046/2004/ QRS_ tutorial.pdf (Date: 5.12.2018)
[14] https://www.calmedu.org/library/ (Date: 5.12.2018)
[15] https://calmedu.libguides.com/az.php (Date: 5.12.2018)
[16] http://www.mdpi.com (Date: 5.12.2018)
[17] https://www.alivecor.com/ (Date: 5.12.2018)
[18] https://www.getqardio.com/ (Date: 5.12.2018)
[19] https://www.crunchbase.com/person/david-albert#section-overview (Date: 5.12.2018)
[20] https://patents.justia.com/patent/9839363 (Date: 8.12.2018)
[21] https://patents.justia.com/patent/20180199844 (Date: 5.12.2018)
[22] https://patents.justia.com/patent/9572499 (Date: 5.12.2018)
[23] Bogomolov A., Nevezhin V., Zhdanov G. Artificial intelligence and expert systems in mobile medicine / «Chronoeconomics», № 3(11). - Page 20-28
[24] Bogomolov A., Nevezhin V. Mobile personal medical system to detect harbingers of a cardiovascular crisis / «Chronoeconomics», № 4(12).2018. - Page 6-13
