WO2014070045A1 - The method and the device for monitoring of diseases - Google Patents

Abstract

The group of inventions relates to medicine, to measurements for diagnostic purposes by measuring the temperature of area of human skin surface, namely, to the method and device for monitoring of diseases. The method of monitoring of diseases, the method comprising the steps of: recording in a memory unit an image of an area of the human skin surface, displaying on a screen the image together with indications of points for temperature measurements to be obtained, obtaining temperature measurements during a monitoring session in points on the area of the human skin surface corresponding with the indicated points displayed on a screen, saving in the memory unit the obtained temperature measurements for each point on the area of the human skin surface, characterized by repeating at intervals during the monitoring period the steps of obtaining the temperature measurements from the points of the area of the human skin surface corresponding with the indicated points displayed on the screen, and saving the obtained temperature measurements for each point on the area of the human skin surface in the memory unit, comparing the temperature measurements obtained during different monitoring sessions from the same points on the area of the human skin surface, and determining and saving in the memory unit monitoring result based on the comparison, wherein the same image of the area of the human skin surface and the same indications of the points for temperature measurements are displayed on the screen during each monitoring session of the monitoring period when the temperature measurements are obtained. Device for monitoring of diseases, the device comprising a set of components comprising: a memory unit (2), a screen (3), a camera (5), an infrared sensor (4), a tool (9) for unification of temperature measurements, a control buttons (7), a power supply (8), a communication module (6), a processor (1) connected to the memory unit, a screen, a infrared sensor, a camera, a communication module, the control buttons, a power supply, and a case. Preferably, the device for monitoring of diseases, the device comprising a set of allocated in a case components comprising: a memory unit, a screen, a camera, an infrared sensor, a tool for unification of temperature measurements, a control buttons, a power supply, a communication module, a processor connected to the memory unit, screen, infrared sensor, camera, communication module, control buttons, and power supply. Preferably, the infrared sensor, the tool for unification of temperature measurements, the power supply for remote module, the communication module for remote module, the control buttons for remote module and the processor for the remote module are formed as a remote module in a separate case and operatively coupled to a set of allocated in another separate case components comprising at least a communication module, a processor, a power supply, a control buttons, a memory unit, a screen, and a camera, altogether named a Device of receiving, processing, saving, and displaying of information. Such Device is, for example, personal computer with web camera, or tablet computer, or Smartphone, or mobile phone with photo camera, or digital video recorder. The offered group of inventions allows to increase the accuracy of monitoring of a disease without participation of a specialist, simplify, and cheapen obtaining of information on the course of a pathologic process and conclusion on the effectiveness of treatment without participation of a specialist.

Description

THE METHOD AND THE DEVICE FOR MONITORING OF DISEASES

The present invention relates to medicine, to measurements for diagnostic purposes by measuring the temperature of area of human skin surface, namely, to the method and device of monitoring of diseases, which can be used for controlling of the course of the disease and evaluation of the effectiveness of treatment at home (outside health-care facilities with or without a specialist's participation), in health-care facilities, and in telemedical consulting.

In medicine, the term monitoring usually refers to the process of systematic and continuous gathering of information on the functioning of various organs and systems of the human body for controlling of the course of the disease, early detection of exacerbations and determination of the effectiveness of the administered treatment

(http://en.wikipedia.org/wiki/Monitoring_%28medicine%29).

In this application, the term monitoring refers to the process of systematic (periodic) data gathering for controlling the course of previously established (diagnosed) diseases, early detection of exacerbations, and determination of the effectiveness of the conducted treatment.

Currently, because of the large number of highly specific devices and methods for diagnostics, there is no problem with establishing of the exact diagnosis in the majority of clinical cases. However, there are no precise, safe, and accessible to common user devices for objective monitoring of the course of the disease or therapy efficiency at home for the majority of the most widespread diseases, which are the main cause of death (vascular, inflammatory, oncology, etc.).

Therefore, at present, people need simple and inexpensive devices for monitoring of diseases at home, similar to blood pressure monitor (monitoring of blood pressure's level, including hypertension and hypotension), cardio-monitor (monitoring of heart diseases), and glucose meters (monitoring of glucose level in blood, including for diabetes mellitus). This need can be successfully satisfied only with unification of the process of self-examination, measurement of the corresponding indicators, and their automated or partially automated processing with the subsequent issuing of the important and clear to any person digital and/or text indicators.

It is well known that electronic thermometer for measuring the overall body temperature is sensitive, but low-specific device for detection and monitoring of diseases. It is also widely known that many human diseases are accompanied by characteristic changes in the surface temperature of the skin in certain areas of the body (i.e., local thermo-signs of diseases). Information on the distribution of temperature values gives an indication of the presence of a pathology in the body (Lahiri B.B., Bagavathiappan S., Jayakumar T., Philip J. Medical applications of infrared thermography: A review // Infrared Physics & Technology. - Volume 55, Issue 4, July 2012, P. 221-235). Thermo signs of diseases usually appear before other clinical manifestations of the disease and vary considerably during the course of treatment. Medical thermography as well as measurement of an overall body temperature has high sensitivity and low specificity (Arora N, Martins D, Ruggerio D, et al.: Effectiveness of a noninvasive digital infrared thermal imaging system in the detection of breast cancer.// Am J Surg 196 (4): 523-6, 2008). Consequently, recording of temperature from the skin surface of the body over time is an effective method of monitoring.

The methods of diagnosis and monitoring of diseases, based on the application of a number of devices for recording temperature values, are known:

1. By using special plates based on microencapsulated liquid crystals (ELC), «contact thermography)) (for example, http://www.atm-charm.ru/stati) displays the temperature of the examined body areas by using a variety of colors. Contact thermography is mostly used for detection of changes in body temperature, occurred in connection with the development of cellulites in its various stages. The advantages: ease of use, safety, feasibility of multiple examinations. However, significant disadvantages do not allow to use this technology in the context of the invention, namely: - Films have limited size, therefore, they can not be imposed on any examined area;

- The method does not allow to digitize and deliver to the computer numeric temperature values at the points of the examined area for subsequent partially automatic evaluation and interpretation of the received picture;

- Application of the method is limited to body areas with the least developed hair-covering and with the smoothest relief, such as hips and thighs (for example, Hoffmann R, Largiader F, Brutsch HP. Liquid crystal contact thermography - a new screening procedure in the diagnosis of deep venous thrombosis // Helv Chir Acta. 1989 Jun; 56(l-2):45-8.).

2. Contact thermometers (for example, Microlife MT1671 - www.microlife.com/WebTools/ProductDB/pdf/IB%20MT%201671 %20EN- RU%201310.pdf) are devices for measurement of temperature of objects by direct contact of skin surface and temperature sensor.

In medicine, contact thermometers are commonly used for measuring overall body temperature orally, rectally, axillary or in the external ear canal. Contact thermometers have the following advantages:

• High accuracy: contact thermometers perform high-precision temperature measurement in all mediums;

• High stability of measurement results: thermometers provide high repeatability of results in measurement series as they have direct contact with the examined object.

However, contact thermometer has significant shortcomings that prevent its use in the context of the invention, namely:

• High inertia during the measurement process, it takes time to reach thermal equilibrium between the sensor of the thermometer and the object; this time can range from a few seconds to a few minutes, which is unacceptable for large number of measurements needed for the adequate assessment of the temperature field of the certain area of the body; • The need to ensure physical contact with the surface of the object for a long time. Temperature can be measured with sufficient accuracy only in the areas that are isolated from the influence of the external air (axilla, ear, etc.). It is impossible to measure the temperature in the open areas of the body accurately with contact thermometer.

Several authors offer diagnostic methods based on the use of contact temperature sensors connected to a computer, and by utilizing a computer program the data from the sensors is used to generate on-screen image of the temperature field on the examined area (for example, EP1326063A1 , 09.07.2003, RU2276965 C2, 27.05.2006; RU2003127766 A, 20.03.2005; RU2267982 C2, 20.01.2006, RU2007138079A, 27.04.2009). The presence of a pathology is detected by the temperature deviation in the examined area of the body from the standard value, which is used as the average value, typical for healthy people, or individual norm of a human, which is obtained by averaging of sensors' indications when measuring the temperature in several points in the examined area on the body.

The drawback of these methods is linked to the fact that the accuracy of reproduction of a temperature field depends on the characteristics of the utilized contact thermometers, whose indications at the specific moment of time are determined by the state of skin, in particular, by its humidity. This requires preliminary measurement of the dependence of the thermometer's indicators on the characteristics of skin, and entering of such dependence into the algorithm of data processing. In addition, indications of the contact thermometer depend on the conditions of reading, for example, on the pressure intensity of contacting the human body with the thermometer. For example, the offered in the method RU 2007138079, 27.04.2009 auxiliary element in the form of firmly pressed suit inevitably causes the greenhouse effect as well as changes in local microcirculation and disturbances of skin's local heat exchange, which basically excludes obtaining any adequate information on the value of the temperature in the examined area ("It is well known that prior to the thermal imaging examination, the areas to be examined should be subjected to 10-15 minutes adaptation to the temperature conditions of the room. This time is sufficient to ensure that a constant temperature gradient between the temperature of the exposed skin's areas of the human body and the room temperature is established... "Citation: olesov S.N., Volovik M.G., Priluchniy M.A. Medical thermo-radio-vision: modern methodological approach: Monograph. - Nizhniy Novgorod: FGU "NNIITO Russian Medical Technologies", 2008. - 184 p. (p. 70-71)). In addition, in the discussed methods, the use of the aggregate of contact sensors does not provide precise positioning of each of them with respect to anatomical features of the examined area, so, the received information about temperature values can not be uniquely matched to individual image of the examined area.

In some methods (for example, EP 1326063, 09.07.2003, JP 2010194073, 09.09.2010), in the presence of the same drawbacks described above, a possibility of visualization of temperature distribution is discussed, but in all cases, authors write only about forming of a discrete range of temperature values in the examined points in a form of a set of rectangular areas, displaying these values (therefore, in comparison with the real thermograms obtained by using thermograph, such visualizations by displaying temperature values in the color form are not thermograms in the conventional sense). The procedure of displaying a temperature field between the examined points is not provided, which eliminates the construction and analysis of real thermograms.

The existing nowadays contact fast-acting infrared thermometers for medical purposes are mainly intended for measurement of overall body temperature. It is conventional to estimate overall body temperature by measuring the temperature of one of the several body areas, namely, the surface of a forehead and/or external acoustic meatus. Accordingly, the existing medical infrared thermometers for measuring overall body temperature are structurally specialized for temperature measurement only in these areas of the body, and not intended to evaluate the local temperature of any area of human skin surface.

There are narrowly specialized infrared contact thermometers, intended to estimate the temperature at certain areas of the body for well-defined pathologies, for example, for measuring the temperature of foot in vascular complications of diabetes. Such thermometers however, provide high error during the measurements of temperature on foot and can not be used to repeatedly measure the local temperature on any part of the body.

3. Pyrometer, (for example, PCE-FIT10 www.industrial- needs.com/manual/manual-pce-FIT10.pdf) is a device for non-contact temperature measurement. The operation principle is based on measuring the power of the thermal radiation of the object mostly in the diapasons of infrared radiation. Pyrometers are used for determining temperature of objects from the distance. Pyrometers are divided into two main groups:

• Brightness (optical) pyrometers and color (multispectral and spectral) pyrometers. Working range: starting from hundreds of degrees Celsius and above (for example, an optical pyrometer OPPIR-09 - http://window.edu.ru/resource/935/28935/files/tsurel61.pdf, color pyrometer SPEKTROPIR 1 1M - http://pribor-neva.ru/katalog/pyro/spektropir.htm), therefore, they are not intended for work with biological objects;

• Radiation pyrometers receive infrared radiation by infrared sensor and evaluate temperature through the recalculated indicator of power of thermal radiation. The diapason of measured temperatures is wide enough (for example, AKIP 9301 - www.mpp-nn.ru/pdf/akip-9301, 9302.pdf), such pyrometers can be used for measurement of the temperature of biological objects, including humans.

An important parameter of a pyrometer is view index. View index (VI) is the ratio of the diameter D of the view spot to the distance L between the pyrometer and the object: VI = D / L. View spot is the area of the examined surface, from which thermal radiation enters the infrared sensor of the pyrometer recording the radiation.

View index is recorded as a ratio: 1 :30, 1 :50, 1 : 100, etc. The lower the VI, the smaller size can have the examined object. Pyrometer with the smaller VI allows to take measurements from a larger distance for the same object. However, for small VI, the power of radiation received by the pyrometer is very small. If the diameter of the view spot is comparable to the size of the working surface of the infrared pyrometer's sensor that directly detect thermal radiation and has a small size in comparison with the size of the examined surface, and the distance between the infrared sensor and the examined surface is small, for example, for contact use of pyrometer, the view spot of the pyrometer can be conventionally presented as a point. In this application, the term "point of temperature measurement" is used throughout the following text in such sense.

Pyrometers have the following advantages:

• Non-contact nature of the measurement. Pyrometer can determine the temperature of the object without physical contact and without introducing additional distortions at a large distance (several meters, tens of meters);

• Speed of temperature measurement of an object. Pyrometer measures the temperature almost immediately, the procedure of temperature measuring is usually 1 second.

However, pyrometers can not be used in the invention in standard methods of their usage for the following reasons:

• The known pyrometers for non-contact use are structurally made in such a way that allows the contact of the distal part of the infrared sensor, which can be made from metal, with the surface of the object at contact use. Metal, as being a material with high thermal conductivity in any conditions, inclusively at room temperature, which is usually lower than the skin surface temperature, irritates skin's thermo receptors and causes skin's vasoconstriction, which leads to cooling of the area of skin and to distortion of temperature values in the measured point.

• impossibility of high precision of aiming to the point of temperature measurement, since directional diagram of infrared sensor of the pyrometer is an expanding cone, as a result (depending on the distance to the object), pyrometer measures the average temperature in a circular area with the diameter ranging from a few centimeters to tens of centimeters. Besides, pyrometers do not allow to control precisely the angle of inclination and the distance to the examined object, which also makes it impossible to locate the particular position of the temperature measuring point on the human body. Laser pointer that is used to correct this deficiency is optimal for use in engineering, but is inapplicable in medicine, particularly because of the possibility of adverse effects, including on the eye's retina;

• pyrometers do not protect from influence of air currents on the skin surface temperature during measurement;

• pyrometers do not allow generating a thermogram, and therefore it is impossible to identify the location of thermo signs of diseases and calculate of the area of the zones with abnormal temperature.

4. Thermograph is the most appropriate device for monitoring the temperature distribution of the examined surface with the use of a matrix consisting of sensitive to infrared light elements recording thermal (infrared) radiation of the object. The temperature distribution is shown on the display (or in the memory) of the thermograph as the color field (thermogram), where the specific color corresponds to certain temperature value. Typically, the temperature range, visible through the objective lens's surface, is shown on the screen. Typical resolution of modern thermographs is from 0.01 to 0.1 °C. In some models of thermographs, the information is stored in the device's memory and can be read via computer connection. These imagers are usually used in conjunction with a laptop or personal computer and the software that allows to receive data from the thermograph in the real time mode. For example, thermograph MoblR M8 (http://www.dias-infrared.com/pdf/mobirm8_eng.pdf) includes matrix of thermo- sensitive elements, video camera, LCD, computer, memory card, and automatically determines maximal/minimal temperature on the field, display maximal/minimal/average temperature, linear profile, isotherm, and histogram.

In medicine, thermographs are used in diagnostics of a number of inflammatory, vascular, and oncology diseases (for example, breast cancer - Lawson R.N. Implications of surface temperatures in the diagnosis of breast cancers // Can Med Ass J 1956, 75:309-310. and others).

Thermographs have the following advantages: • construction of two-dimensional thermogram of the body area, instead of getting temperature measurement at a point allows to assess the condition of the examined object quickly and at a time, and, for instance, to allocate thermo signs of the disease;

• rate of temperature measurement: thermograph measures the temperature based on radiation principle and constructs a thermogram almost instantly;

• non-contact nature of measurement allows to determine the temperature of the object without physical contact, without introducing additional distortions at examination at a large distance (meters);

• some models allow to impose the received thermogram on the photographic picture of the object at the moment of measurement.

However, thermographs have significant shortcomings that prevent their effective use in the context of the invention:

• thermographs fail to provide accurate repeatability of measurements that are carried out periodically, and therefore, it is impossible automatically compare thermograms for monitoring purposes. Under the terms of thermography examination, the patient should be in a comfortable relaxed position, which is incompatible with rigid fixation of the patient's positioning, providing the same orientation of the body parts in front of the thermograph's lens for precise repeatability of measurements. The patient would have new different position (rotated, shifted) at every measurement. In addition, the processes of breathing, heart beating, and intestinal peristalsis can introduce distortions, which also leads to impossibility of combining and automatic interpretation of repeated thermograms;

• two types of thermal radiation of the object are essential for temperature measuring: self-radiation and reflected radiation. Information on the temperature of the object is carried only by self-radiation, which extends according to normal (perpendicular) from each point of the object's surface; the reflected radiation contains information about the temperature of the environment, and only distorts the true value of the object's temperature. The greater the deviation from the normal, the greater the surface area, from which the reflected radiation comes, the greater the measurement error. During thermography examination of the surface of the human body, this error is worsened by the complexity of the relief, which leads to different mutual re-reflection at different angles of orientation of the thermograph, particularly in the areas of natural hollows (navel, inter-finger spaces, etc.) and adjoining parts of the body;

• thermography examination involves adhering to the number of conditions: besides the maximum identity of the posture and the position in front of the thermograph in each session, stable temperature in the room must be maintained as well as the absence of air flows, and the number of other requirements (Hooshang Hooshmand, Masood Hashmi, Phillips Eric M. Infrared Thermal Imaging As A Tool In Pain Management - An 11 Year Study, Part I of II // Thermology international. - 1 1/2 (2001)). The totality of these requirements with varying degree of standardization can be maintained only in specialized institutions, in connection with which, the use of thermographs is impossible at home, in contrast to the use of blood pressure monitors, heart rate monitors, and glucometers.

Besides, usage limitations of thermographs are:

• inability of examination of the body areas with complex relief of the surface (projections with negative angles of inclination, hollows, etc.) as the areas of interest can be geometrically covered by elements of the relief;

• inability of measuring the areas covered by hair, as hair shield thermal radiation;

• high cost of a thermograph and the need for its regular maintenance.

The disadvantage of thermography methods of diagnosis and monitoring is related to the fact that the study of the pathological process is carried out by the displayed on the screen temperature field, and the specialist conducting the examination only associatively connects the temperature field with the examined area and assesses it largely subjectively, based on his own experience. The experience of the specialist includes formalized as well as non- formalized components. Analysis and interpretation of thermograms is mainly based on non- formalized component of the specialist's experience, as in the case of the analysis of the image of the temperature field, which comprises of a large number of heterogeneous inextricably interconnected graphic elements, integrated perception of the image takes place, allowing to retrieve diagnostic information in the context of the specialist's clinical experience and knowledge. "The formalization of medical experience is still at a very low level" (I.M. Gelfand and others. Essays on the collaboration of mathematicians and physicians. M., 201 1). Consequently, today, thermography and the received thermograms are largely subjectively interpreted, so the method is complex and expensive, and is carried out only by trained specialists in health-care facilities.

Thermography diagnosis has high sensitivity but low specificity. For example, infrared thermography has sensitivity of 97% and specificity of only 44% in the examination for the purpose of detection of breast cancer (Arora N, Martins D, Ruggerio D, et al.: Effectiveness of a noninvasive digital infrared thermal imaging system in the detection of breast cancer.// Am J Surg 196 (4): 523-6, 2008). Because of this as well as because of the absolute safety, infrared thermography is not optimal for the diagnostics, but it is ideal for monitoring of a wide range of diseases (inflammatory, neoplastic, vascular, degenerative) at the presence of the earlier established precise diagnosis.

The existing attempts of partially automated thermography diagnostics (but not monitoring) are based on the comparison of thermograms of patients with averaged norm from the accumulated database. However, this approach can not be applied to the monitoring of the diseases of the specific patient. Comparison of skin temperature of the specific person with a certain averaged norm is not correct, as the temperature of the skin varies in a very wide range (for a healthy person it varies from about 37°C to 20°C), and its distribution on the body surface is individual and depends on many factors (peculiarities of thermoregulation, location of subcutaneous blood vessels, thickness of subcutaneous fat, etc.). For monitoring of health condition, comparison of thermograms of exactly one person at different times is important, and only such comparison gives information on the dynamics of individual pathological process. Furthermore, implementation of the proper monitoring based on comparing thermograms from a standard thermograph is only feasible when the following conditions are strictly met: the registration of the temperature field of the same object in the same conditions at different times with the subsequent comparison of the obtained thermograms in one range of temperatures, which is almost impossible. In addition, when using thermographs, it is almost impossible to fix the same distance and angle between the thermograph and the examined object with the necessary precision in repeated sessions. This is aggravated by the fact that the human body has very complex relief of the surface. And if a person does not take exactly the same position of the examined area of the body relative to the lens of the thermograph during each session, which is practically impossible, the obtained thermograms can be hardly comparable, and automatic analysis becomes impossible due to the impossibility to compare the thermograms obtained at different times.

Thus, there is a need for the development of methods and devices that can perform individual monitoring at home (outside health-care facilities and/or without participation of the specialist) based on temperature measurements of the human body and generated thermograms, i.e. partially automatically or automatically (by using a computer program) give conclusions on the dynamics of pathological processes, assess the effectiveness of treatment.

The method of displaying the temperature field of a biological object, protected by the patent RU 2452925 CI , cl.G01J5/48; GOl l/00; A61B5/00, publ. 10.06.2012 and adopted for the nearest equivalent (prototype) is the closest by the technical essence and the achieved result to the proposed method of monitoring of diseases.

The method, by prototype, includes the entry of the image of the examined area of the body of a biological object to the computer database, than, the image is displayed on the computer screen, herewith, the points of temperature measurement on the examined area of the object are displayed and indicated on the image of the object on the screen, and after conducting measurements and processing of measurements in the computer, the image of the temperature field is formed by the computer program on the image of the examined area of object. The examined area is previously photographed with a photo camera, the photo or the model of the image of the body area is entered into the computer database and displayed on the computer's screen, the temperature of the examined area is mainly measured by infrared pyrometer or thermometer.

The common sign with the claimed method of monitoring of diseases is fixation and displaying on the computer screen of the temperature values of measurement points and the temperature field (thermogram) imposed on the image of the examined area of the body (area of human skin surface), previously entered in the computer memory; and temperature measurement on the examined area only in the points corresponding to the points originally imposed on the image, which increases the accuracy of diagnostic procedures. However, the method by the prototype is not sufficient for monitoring of diseases for the following reasons:

• Despite the fact that the patent-prototype states: "The present invention ... can be applied in medical practice for diseases' diagnostics and for monitoring of the dynamics of the disease during the course of treatment" (page 1 , lines 7-10), neither text nor illustrative material of the patent does not substantiate the technical feasibility of implementation of the method described herein for the purposes of monitoring of diseases, implementation of the method for purposes of monitoring of the diseases' dynamics is not disclosed in the patent;

• The method does not contain information on the procedure of automatic or partially automatic implementation of monitoring, that is by processor and/or software (via function of processor and/or computer program);

• The method does not contain descriptions of conditions, without compliance with which the comparison of measured temperature values and thermograms by the software becomes correct or incorrect (such conditions are disclosed below in the description of the claimed invention);

• As a device for temperature measuring, it is recommended to use pyrometers or infrared thermometers ("It is advisable to measure the temperature by infrared thermometer or infrared pyrometer" - page 5, line 20 of the patent- prototype). However, due to the previously mentioned disadvantages, neither pyrometers nor thermometers of previously known structures and in previously known methods of their application can not be used for implementation of the claimed invention. In particular, these devices do not provide the proper degree of unification of the procedure of multiply repeated correct temperature measurements at many points of skin surface area, that is necessary just for monitoring. Standard ways of usage of pyrometers, infrared thermometers, and thermographs does not prevent the air flows from influencing the temperature of the skin surface in the process of non-contact measurement, does not support a constant distance and angle relatively skin surface, and, contact thermometers and temperature sensors during contact measurement allow direct contact of a thermal sensor and the skin surface during the contact measurement, which, in both cases, generates measurement errors.

Thereby, the described in this patent procedure of displaying the temperature field allows to obtain a thermogram, superimposed on a photographic image or a model of patient's body part, comprising a great number of heterogeneous intricately interrelated to each other elements (anatomical parts, temperature values, temperature transitions), and sufficient for the diagnostic purposes of a specialist in thermography, who perceives the thermogram integrally and retrieves contained therein diagnostic information in accordance with his/her clinical experience. However, analysis of thermograms can not be done by a user without special education, who needs partially automatic or automatic (by means of software, according to which a processor is configured) acquisition of information in the form of simple and accessible quantitative and text indicators of disease's course.

The possibility of generating thermograms is important, but not essential element of the claimed invention. Color perception of the image is a subjective process, the number of perceived colors varies depending on age, gender, etc. The overall quality of color perception decreases with age. In addition, various aberrations of color perception are frequent and they are accompanied by sharp distortion of color perception (color blindness and other diseases, hereditary or accompanying certain diseases of the brain).

Analysis of the temperature gradients according to the results of temperature measurement at points without generating of thermograms provides important information in the claimed invention, herewith, the generating and analysis of thermograms allow to obtain additional, but also valuable information.

The implementation of the method by the prototype also requires availability and simultaneous use of a large number of technical tools: photographic camera, computer, computer screen, infrared thermometer or pyrometer, which significantly hampers its practical use at home.

The purpose of the claimed invention is creation of the method and the device for monitoring of diseases, which allows: partially automatic tracking of the dynamics of the course of the disease, evaluation of the effectiveness of therapy by thermal signs of evolution of the disease, partially automatic issuing of conclusions and giving recommendations to the user, and, on user's request, transferring of saved in memory unit measurement results to the interested parties (including the doctor) through communication channels.

Herewith, the method and the device allow to implement mechanisms of monitoring of treatment course of diseases at home, without attending a doctor and performing expensive tests.

The technical result, achieved in the solution of the stated problem, is in increasing of the accuracy of monitoring of a disease without participation of a specialist, simplification and reduction the cost of obtaining information on the course of the pathological process, and making conclusions on the effectiveness of treatment without participation of the specialist. According to the first aspect of the present invention, a method of monitoring temperature variations of an area of the human skin surface comprises the steps of: recording in a memory unit an image of an area of the human skin surface; displaying on a screen the image together with indications of points for temperature measurements to be obtained; obtaining temperature measurements during a monitoring session in points on the area of the human skin surface corresponding with the indicated points displayed on a screen; saving in the memory unit the obtained temperature measurements for each point on the area of the human skin surface, characterized by repeating at intervals during the monitoring period the steps of obtaining the temperature measurements from the points of the area of the human skin surface corresponding with the indicated points displayed on the screen, and saving the obtained temperature measurements for each point on the area of the human skin surface in the memory unit; comparing the temperature measurements obtained during different monitoring sessions from the same points on the area of the human skin surface; and determining and saving in the memory unit monitoring result based on the comparison, wherein the same image of the area of the human skin surface and the same indications of the points for temperature measurements are displayed on the screen during each monitoring session of the monitoring period when the temperature measurements are obtained.

Preferably, the claimed method is carried out by the device formed from a set of components comprising: a memory unit, a screen, a camera, an infrared sensor, a tool for unification of temperature measurements, control buttons, a power supply, a communication module, a processor connected to the memory unit, screen, infrared sensor, camera, communication module, control buttons, power supply; and a case.

Preferably, the method is carried out by the device, the set of its components is housed in the case (hereinafter "the first version").

In another preferable version of the invention, the method is carried out by the device which is particular realization of the first version, wherein the additional infrared sensor, the additional tool for unification of temperature measurements, the additional power supply, the additional communication module, the additional control buttons and the additional processor are formed in a separate case as an additional module, which is operatively coupled to the device comprising a memory unit, a screen, a camera, an infrared sensor, a tool for unification of temperature measurements, a control buttons, a power supply, a communication module, a processor connected to the memory unit, screen, infrared sensor, camera, communication module, control buttons, and power supply.

In another preferable version of the invention, the method is carried out by the device (hereinafter "the second version") formed from a set of components comprising the infrared sensor, the tool for unification of temperature measurements, the power supply for remote module, the communication module for remote module, the control buttons for remote module and the processor for remote module are formed in a separate case as a remote module, which is operatively coupled to a set of allocated in another separate case components comprising at least a communication module, a processor, a power supply, control buttons, a memory unit, a screen, and a camera, altogether named hereinafter a Device of receiving, processing, saving, and displaying of information, for example, personal computer with web camera, or tablet computer, or Smartphone, or mobile phone with photo camera, or digital video recorder.

In another preferable version of the invention, the method is carried out according to all the above listed preferable versions wherein the device at least two infrared sensors with tools for unification of temperature measurements.

The resulting image with indicated graphical indications of points hereinafter is referred to "template".

In an alternative example, graphical indications of points for temperature measurement can be indicated on the examined area of the image, being obtained from the memory unit.

In an alternative example, graphical indications of points for temperature measurement can be indicated on the examined area of the image manually. In an alternative example, manual measuring of temperature can be made by the device with using of a tool for unification of temperature measurements, while tool has a contact with skin surface at position maximally close to perpendicular.

In an alternative example, the image of the examined area can be made in the form of photographical image.

In an alternative example, the image of the examined area can be made in the form of model 2D (two-dimensional) or 3D (three-dimensional) image.

In an alternative example, the monitoring results can be generated in a form of a text message.

In an alternative example, the monitoring results can be generated in a form of a graphic message.

In an alternative example, the monitoring results can be generated in a form of an audio message.

In an alternative example, the result can be an indication of changes in a temperature gradient across the area of the human skin surface between monitoring sessions.

In an alternative example, the monitoring results of the monitoring can be generated in the form of a thermogram.

In an alternative example, the result can include an indication whether the temperature gradient is within the predefined value range.

According to a second aspect of the invention, a device for monitoring temperature variations on an area of the human skin surface, the device comprising a set of components comprising: a memory unit, a screen, a camera, an infrared sensor, a tool for unification of temperature measurements, control buttons, a power supply, a communication module, a processor connected to the memory unit, screen, infrared sensor, camera, communication module, control buttons, and power supply; and a case.

Preferably, the processor of the device for monitoring temperature variations on an area of the human skin surface is configured to record in the memory unit an image of an area of the human skin surface obtained from the camera, display on the screen the image together with indications of points for temperature measurements to be obtained, obtain from the infrared sensor during a monitoring session temperature measurements from the points on the area of the human skin surface corresponding with the indicated points, displayed on a screen, saving in the memory unit the obtained temperature measurements for each point on the area of the human skin surface, repeat at intervals during a monitoring period the steps of obtaining the temperature measurements from the points on the area of the human skin surface corresponding with the indicated points, displayed on the screen, and saving in the memory unit the obtained temperature measurements for each point on the area of the human skin surface, compare the temperature measurements obtained during different monitoring sessions from the same points on the area of the human skin surface, and determine and saving in the memory unit a result based on the comparison, wherein the same image of the area of the human skin surface and the same indications of the points for temperature measurements are displayed on the screen during each monitoring session of the monitoring period when the temperature measurements are obtained.

Preferably, the case houses the set of the device components (hereinafter "the first version").

In another preferable version of the invention, a particular realization of the device by the first version, wherein the additional infrared sensor, the additional tool for unification of temperature measurements, the additional power supply, the additional communication module, the additional control buttons and the additional processor are formed in a separate case as an additional module, which is operatively coupled to the device comprising a memory unit, a screen, a camera, an infrared sensor, a tool for unification of temperature measurements, control buttons, a power supply, a communication module, a processor connected to the memory unit, screen, infrared sensor, camera, communication module, control buttons, and power supply.

In another preferable version of the invention (hereinafter "the second version"), the infrared sensor, the tool for unification of temperature measurements, the power supply for remote module, the communication module for remote module, the control buttons for remote module and the processor for remote module are formed in a separate case as a remote module, which is operatively coupled to a set of allocated in another separate case components comprising at least a communication module, a processor, a power supply, control buttons, a memory unit, a screen, and a camera, altogether named hereinafter a Device of receiving, processing, saving, and displaying of information, for example, personal computer with web camera, or tablet computer, or Smartphone, or mobile phone with photo camera, or digital video recorder.

In another preferable version of the invention, the device according to all above listed device versions, wherein the device has at least two infrared sensors with tools for unification of temperature measurements.

Particular instances of implementation of the claimed device include a set of instances.

Processor can be executed, for example, on standard platforms of class SoC on core ARMv9 or analogous with similar performance and energy consumption, for example, ARM architecture, x86.

In an alternative example, standard platforms can be used as the basic software, for example, Android 2.3, Qt, Windows Mobile, or similar, ensuring effective functioning of the device.

In an alternative example, memory unit can be organized in a form of a relational database or flat file storage, SQLite, for instance, can be used as a relational database.

In an alternative example, additional memory block can be possible, for example, on a flash-card that can be disconnected for subsequent usage of the saved on it data on a personal computer.

In an alternative example, screen can be made touch-sensitive.

In an alternative example, sensor of the screen can be made on resistive or capacitive matrix.

In an alternative example, screen can be made with a diagonal of, for example, 3.5", with resolution of, for example, 320x240 pixels at the color depth of, e.g., RGB 16 bit.

In an alternative example, infrared sensor can be made, for example, on the basis of standard infrared sensor with maximum sensitivity in the temperature range of biological objects from 20 to 45 °C.

In an alternative example, infrared sensor can be made, for example, on the basis of sensor MLX90614.

In an alternative example, communication module can be made wire communication unit.

In an alternative example, communication module can be made wireless communication unit.

In an alternative example, wireless communication unit can be made by using standard solutions, such as, for example, GPRS, IEEE 802.1 1 , 802.15, etc.

In an alternative example, power supply can be made battery.

In an alternative example, battery can be made, in the form of Li-ion or Ni- Cd battery.

In an alternative example, a tool for unification of temperature measurements can be made on one end of the case of the device, for example, in a form of cylindrical protuberance with rounded edges, made of a resilient, biologically neutral material with minimal coefficient of thermal conductivity.

In an alternative example, a tool for unification of temperature measurements can be made in a form of a protuberance, for example, from treated ABS plastic.

In an alternative example, the protuberance can be made, for example, from hypoallergenic plastic made of polyurethane.

In an alternative example, the protuberance can be made, for example, cylindrically.

In an alternative example, hollow metal truncated cone with open ends (further referred to as the "bell") can be installed inside the protuberance, herewith, the infrared sensor is built into the narrow top of the cone, under condition that metal elements of the infrared sensor do not project out or coincide with the end part of the protuberance, therefore providing the absence of the contact of the infrared sensor and the skin surface.

In an alternative example, the diameter of the cylindrical protuberance can be sufficient to provide an accurate visual positioning on a point of temperature measurement, and to provide the sufficient view index for carrying out of examination, for example, 8 mm.

In an alternative example, the device for monitoring of diseases can have a function of changing the assignments of buttons when using right or left hand.

In an alternative example, case can be made of plastic.

The group of inventions is illustrated with the following graphic materials.

Fig. 1 shows the logic scheme of realization of the method of monitoring of diseases for any versions.

Fig. 2 shows an image of the general view of a device for monitoring of diseases by the first version (A - the view from the front side, B - the view from the back side, C - top view, D - bottom view, E - view from the right side, F - view from the left side, G - view from the front side with rotation relative to the longitudinal axis, H - view from the front side with rotation and tilt with respect to the longitudinal axis). Numerical symbols on Figures 2 to 10 are commented below.

Fig. 3 shows an image of the general view of the device for monitoring of diseases with internal components by the first version.

Fig. 4 shows a block diagram of the operation of the device for monitoring of diseases by the first version.

Fig. 5 shows an image of the section of the tool for unification of temperature measurements in the device for monitoring of diseases by the both versions, including additional and remote modules.

Fig. 6 shows an image of the additional module by the particular realization of the first version.

Fig. 7 shows an image of a possible version of assembly and elements of the device for monitoring of diseases by the first version.

Fig. 8 shows an image of the general view of a device for monitoring of diseases by the first version containing more than one infrared sensor.

Fig. 9 shows an image of an additional module by the particular realization of the first version and, by the second version, remote module, with mounted more than one infrared sensor in the case.

Fig. 10 shows an image of the general view of a remote module, operatively coupled to a Device of receiving, processing, saving, and displaying of information, by the second version.

Fig.1 1 shows a block diagram of the operation of the device for monitoring of diseases by the second version.

Fig.12 shows two-dimensional image of an examined area of human skin surface displayed on screen, by first version (A) and second version (B).

Fig. 13 shows three-dimensional image of an examined area of human skin surface displayed on screen, by first version (A) and second version (B).

Fig. 14 shows two-dimensional image of an examined area of human skin surface with indicated graphic images of points for temperature measurement displayed on the screen, by first version (A) and second version (B).

Fig. 15 shows three-dimensional image of an examined area of human skin surface with indicated graphic images of points for temperature measurement displayed on the screen, by first version (A) and second version (B).

Fig. 16 shows two-dimensional image of an examined area of human skin surface with indicated graphic images of points for temperature measurement displayed on the screen with values of temperature, corresponding to these points, by first version (A) and second version (B).

Fig. 17 shows three-dimensional image of an examined area of human skin surface with indicated graphic images of points for temperature measurement displayed on the screen with values of temperature, corresponding to these points, by first version (A) and second version (B).

Fig. 18 shows two-dimensional image of an examined area of human skin surface with indicated graphic images of points for temperature measurement displayed on the screen with values of temperature, corresponding to these points and with a thermogram, constructed by the temperatures corresponding to the indicated points, as well as with the results of the first examination, by first version (A) and second version (B). The conclusion on the screen is "Maximal thermo asymmetry is 1.2 °C. Longitudinal gradient is 0 °C on left and 0.8 °C on right".

Fig. 19 shows three-dimensional image of an examined area of human skin surface with indicated graphic images of points for temperature measurement displayed on the screen with values of temperature, corresponding to these points and with a thermogram, constructed by the temperatures corresponding to the indicated points, as well as with the results of the first examination, by first version (A) and second version (B). The conclusion on the screen is "Maximal thermo asymmetry is 1.2 °C. Longitudinal gradient is 0 °C on left and 0.8 °C on right".

Fig. 20 shows the results of examination with the results of monitoring displayed on the screen, by first version (A) and second version (B). The conclusion on the screen is "The disease's dynamics: thermo signs of positive dynamics".

Fig. 21 shows is an option of the use of the device by a patient, by first version: the device is held by hand; the correct position of the device in left and in right hand is shown.

Fig. 22-58 illustrate specific examples of use of the claimed method and the device, which are explained in the respective examples in the following text.

Structurally, the device for monitoring of diseases, by first version, on Fig. 2-9 contains: 1 - processor; 2 - memory unit; 3 - screen; 4 - infrared sensor; 5 - camera; 6 - communication module;

7 -control buttons; 8 - power supply; 9 - tool for unification of temperature measurements; 10 - case. Processor 1, memory unit 2, screen 3, infrared sensor 4, camera 5, communication module 6, control buttons 7, power supply 8, and tool for unification of temperature measurements 9 are installed in one case 10.

Processor 1 is connected to the memory unit 2, screen 3, infrared sensor 4, camera 5, communication module 6, control buttons 7, and power supply 8.

Processor 1 , for example, can be executed on standard platforms of class SoC on core ARMv9 or analogous, with similar performance and energy consumption of ARM architecture, x86, or any other;

As the basic software, standard platforms can be used, such as, for example, Android 2.3, Qt, Windows Mobile, or similar, ensuring functioning of the device.

Memory unit 2 can be made, for example, on a flash-card and can be disconnected for subsequent usage of the saved on it data on a personal computer.

Memory unit 2 can be organized in a form of a relational database or, for example, flat file storage. SQLite, for instance, can be used as a relational database.

The screen 3 can be made touch-sensitive. Herewith, sensor of the screen can be made on resistive or capacitive matrix.

The size of the screen 3 can be chosen based on the requirements of ergonomics, for instance, to lay comfortably in hand. Diagonal of the screen 3 can be, for example, 3.5", with resolution of, for example, 320x240 pixels at the color depth of, for example, RGB 16 bit.

The infrared sensor 4 can be made, for example, on the basis of standard sensitive infrared sensors with maximum sensitivity in the temperature range of biological objects from 20 to 45 ^°C. For example, infrared sensor MLX90614 can be used.

The device for monitoring of diseases can contain several additional infrared sensors 4 that can be situated in one or different end-face of the case 10. In this case, additional holes can be made in case 10, the number of holes will correspond to the number of sensors 4. For example, three holes can be executed in the case 10, while in at two of these holes an infrared sensor 4 can be mounted, and, the lens of the camera 5 can be mounted in another hole.

Additional or remote module with infrared sensor 4 can be connected to the device with the use of a flexible cable as well as with the use of wireless connection.

In case of the use of a flexible cable, for example, of the length of 1.5 m, the mechanism of winding of a flexible cable with restoring spring return can be executed in the case 10.

In case of use of wireless connection, additional or remote module with infrared sensor 4 can be executed together with transmitting unit and the battery power unit 8; in this case, the receiving unit should be set in the case 10.

Wireless realization of communication module 6 provides wireless transfer of data on the results of measurements from the person to the interested parties or to the database for subsequent analysis. Wireless connection unit 6 can be made by using standard solutions, such as GPRS, 802.1 1 , 802.15, etc.

Power supply 8 can be made battery-operated, to allow its use in conditions outside home and at home for reducing patient's the risk of injury by electricity. As such battery power unit, Li-ion or Ni-Cd battery can be used.

The tool for unification of temperature measurements 9 can be made in one end of the case 10, for example, in a form of cylindrical protuberance with rounded edges, made of a resilient, biologically neutral material with minimal coefficient of thermal conductivity, for example, from treated ABS plastic. The tool for unification of temperature measurements 9 can be made without protuberance, in a form of construction positioning of infrared sensor inside the device and set apart from the outer border of the case. However such solution prevents a precise positioning of the tool for unification of temperature measurements on the point of measurement in the first variant of use of the device and therefore is not preferable.

The protuberance can be made from hypoallergenic plastic, for example, made of polyurethane to ensure the absence of negative reactions of human organism, and the absence or minimal impact of air currents, and absence of influence of metallic blunted cone and infrared sensor on the local skin temperature, which is achieved by the use of materials with minimal thermal conductivity.

The bell, for example, hollow metallic blunted cone with open ends, can be installed inside the protuberance, herewith, the infrared sensor 4 is built into the narrow top of the cone. The diameter of the cylindrical protuberance should be sufficient to provide an accurate visual positioning on a point of temperature measurement, and to provide the sufficient view index for carrying out of examination, for example, 8 mm.

The case 10 can be made, for example, of plastic, providing sufficient mechanical strength, as well as easiness to clean. The material of the case 9 must be resistant to the means of cleaning and disinfection.

The device for monitoring of diseases by the first version can contain information carrier and the apparatus for connecting additional information carrier.

The production of the device by the first version can be carried by standard technologies. The main components of the device, such as processor 1 , the memory unit 2, screen 3, infrared sensor 4, camera 5, and communication module 6 can be made, for example, on a printed circuit board, which provides small size of the device and low power consumption. The case 10 can be made, for example, by pressure die casting, or by vacuum casting. The bell, hollow blunted (focusing) cone with open ends, not contacting the skin surface, can be made of metal, for example, by stamping method and is mounted inside the case relative to the tool for unification of temperature measurements 9, in any realization version.

The components inside the case 10 are set so as stray thermal radiation (heat) of the components does not affect the accuracy of the temperature measurements of infrared sensor 4. One of the options of the placement is installation of most heated during operation units (processor 1, memory unit 2, camera 5, power supply 8) on the maximal distance from the infrared sensor 4. For example, the infrared sensor 4 and camera 5 can be placed at opposite ends, or at opposite sides of the case 10.

In order to ease the assembly of the device by the first version, one-time holders inserted after assembly, can be used in the case 10 for mounting of electronic components. For easing of fixation of components of the case 10 relative to each other, one-time catches can be used along the perimeter of the device, or other means of fixation can be used.

Dimensions of the device by the first version should be done in such a way that it could comfortably lay in user's hand (do not go beyond the palm with open fingers) and could be held without using the second hand.

The second version of the device for monitoring of diseases comprises of allocated in remote case at least one infrared sensor with the tool for unification of temperature measurements, power supply, control button, the communication module, a simple processor which is minimally enough for support of the device functions, and this remote module is operatively coupled to the Device of receiving, processing, saving, and displaying of information, comprises of allocated in remote case at least processor, memory unit, screen, camera, power supply, control button, the communication module. The Device of receiving, processing, saving, and displaying of information is, for example, personal computer with web camera, tablet computer, Smartphone, mobile phone with photo camera, digital video recorder.

The image of the general view of the device for monitoring of diseases by the second version is shown on Fig.10, numerical indication is the same as on Fig.1-9, because the set of components of the Device of receiving, processing, saving, and displaying information for the second version of the device differs from the set of components of the first version of the device only by the absence of the infrared sensor and the tool for unification of temperature measurements.

The device for monitoring of diseases by the first version works in the following way, technical algorithm of operation is described below. Button 7 allows to select one of the several control functions through the use of the menu with a number of functions. Camera 5 registers the photoimage and sends it to the processor 1 by pressing control button 7, corresponding to the camera; processor 1 saves the recorded photo image in the memory unit 2 and displays it on the screen 3. Instead of registering the image by the camera 5, the processor can retrieve 2D or 3D model (the ready image) from the memory unit 2 and display it on the screen 3. Infrared sensor 4 registers the temperature and transmits it to the processor 1 by pressing the control button 7, corresponding to the infrared sensor; the processor saves the recorded temperature in the memory unit 2, and displays it on the screen 3. When reaching the sufficient number of temperature measurements (corresponding to the program, according to which the processor 1 is configured) in the memory unit 2, the processor 1 creates a thermogram, and conclusion in accordance to the program and performs the imposition of the thermogram on the previously registered photo image from the camera 5 or on 2D or 3D model (the ready image) from the memory unit 2, stored in the memory unit 2, and displays the result on the screen 3. By pressing the control button 7, corresponding to communication module, the processor 1 receives the registered images, thermograms, conclusions and values of measured temperatures and the results of its comparing from the memory unit 2 and can transmits them to the communication module 6 for their subsequent transmission to interested parties. In order to ease the usage of the device during its operation in the right or the left hand, it can have a function reassignment of buttons' functions. For example, the button located on the left from the lens of the infrared sensor can have the function of receiving the temperature from the infrared sensor or registration of the image from the camera.

Additional module equipped with a simple processor minimally enough for support of the additional module functions and with at least one infrared sensor with the tool for unification of temperature measurements, which can be optionally complemented for remote usage of the device by the first version and connected to it by wired or wireless connection, greatly facilitates the application of the first W

30 versions of the method and the device by person without assistance as well as by the assistant in case of examination of such areas as head, back, and face. The convenience of use of the additional module can consist in the possibility of measuring without losing eye contact with the screen of the device and, consequently, increasing the positioning accuracy of infrared sensors relative to the skin surface, as well as the possibility of measuring in the hidden cavities (for example, ears or internal cavities during surgery) and in hair-covered areas, where there are high requirements on the dimensions of the measurement part. Convenience of use of the additional module can also consist in the possibility of measuring by the person's assistant of the skin surface area that the person can not examine by oneself, such as the back. The additional advantage is the possibility of disinfecting of additional module, which is in direct contact with the person, independently from the primary device, as well as the possibility of complete replacement of the additional module without replacing the primary device.

The device by the first and second versions, including the additional and remote module, can be additionally equipped with several infrared sensors located sequentially at one end of the case, herewith, each of the sensors can be equipped with the tool for unification of temperature measurements, or, several sensors can be set in one tool. In the second instance, the tool for unification of temperature measurements can be a truncated cone, open at both ends, but with shape of an ellipse in the section. Such constructive design allows measurement of temperatures in several points simultaneously (for example, by pressing the button), on the assumption of the distances between the points of the template coincide with the distance between infrared sensors, which can greatly simplify self-examination or specialists' work with the device at examination of the areas of the human skin surface with relatively flat geometric surface, for example, mammary gland or back.

The device by the first and second versions can be additionally equipped with the block of connection to remote display (Fig. 22), made, for example, according to the standard HDMI. The use of an remote display with substantially greater diagonal than the diagonal of the device itself facilitates the visualization of the template, anatomical signs, and monitoring results (for example, the thermogram), which significantly facilitates the positioning of the infrared sensors on the measurement points, and, in case of use by medical staff, it allows to explain clearly to the patient how use the device. Large remote display also makes the device assessable to visually impaired people, who can not see images on a small screen of the device due to the health reasons.

The availability of a microphone and a speaker allows to implement the function of audible notification of a person on the results of monitoring, which facilitates information's perception by hearing-impaired people, and allows to set up audio connection with a consultant, provided by wireless connection block (Fig. 23). Due of this, the consultant has the possibility to assess the correctness of the application of the device by the patient, determine the correctness of use of a template, conduct the necessary training, and promptly control the condition of the patient.

The connected memory block, such as SD CARD, which is a possible component of the device, allows to transfer the database of measurements to a computer, where more detailed analysis of monitoring results as well as comparison of monitoring results with the results of other persons is possible. Additionally connected memory block can be used for transferring of the updated templates to the device, as well as for updating its software. The same function can be provided by the block of connection with remote computer (Figure 24), without using the connected memory block.

The function of adjustment of the device for the left and the right hand (mirroring change of button assignments) allows convenient operation of the device by the left or the right hand for right-handed and left-handed people, as well as monitoring of the areas, which access is more convenient either by the left or the right hand (for example, left or right collarbone or left or right elbow).

The method for monitoring of diseases by using the first version of the device for monitoring of diseases is carried out in the following way, the basic sequence of actions of the person or medical staff is described below.

In the first session of self-examination (examination), the image of the examined area of human skin surface is obtained from the camera 5 and displayed on the screen 3 in the form of a photographic image: Fig. 25A and 26A for examination and self-examination respectively. Alternatively, at the request of the user, 2D or 3D models of an area of human skin surface retrieved from the memory unit 2 to the screen 3 can be used as an image of the examined area. By using control buttons 7, shifting, rotation, and scaling of the image can be done on the screen 3. Graphical indications of points for temperature measurement are indicated on the image of the examined area, for example, by imposing the ready- made set of graphical indications of points, available in the program (from the memory unit), or that template can be formed sequentially by hand (Fig. 27A and 28A). In case of the alignment of graphical indications of points by hand, the user is guided by the examples stored in the memory unit 2 (or retrieved from an external source, for example, from the User's Manual); or, at the request of the user, the user is guided by doctor's recommendations or by telemedical technologies through communication channels. Images of the examined area with indicated graphical indications of points for temperature measurement are entered into the memory unit 2 once to form a template that is stored in the memory unit 2 for further use during the monitoring period. The saved template is retrieved from the memory unit in the repeated monitoring sessions.

The necessity to create, save, and use the new template (new photo image with the graphical indications of points for temperature measurement put on it) appears in case of the significant, for measurement accuracy, change in the appearance or size of the examined area (for example, decreasing swelling or wound healing) causing mismatch of the image of the area and the actual area.

Then, the temperature in each point of the examination area of human skin surface is measured by the infrared sensor 4 which is component of the device and/or of additional module (Fig. 29A and 3 OA), following which, information in the form of the temperature data at each point (Fig. 31A and 32A) is received. Measurement of temperature on the examination area in visual correlation with graphical indications of points on the template is done repeatedly during the time interval chosen by the user. Measurement of the temperature at the points of the examined area is carried out with maximum unification of the distance and the angle (with minimal deviation from perpendicular) between the surface of examination area of skin and the sensor by using the tool for unification of temperature measurements 9, made, for example, in a form of a projection from a biologically neutral material around the hole, in which an infrared sensor 4 is installed. A thermal conductivity of the material of the tool must be low in any conditions and does not influence skin surface temperature. For example, at recommended examination conditions (including room temperature, which is usually lower than the skin surface temperature), in order to avoid irritation of skin's thermo receptors and does not cause skin's vasoconstriction, which leads to cooling of the area of skin and to distortion of temperature values in the measured point. The measurement results are saved in the memory unit 2 and processed with the issuance of numeric indexes, audio, and text messages. Besides, based on the results of the measurements, thermogram is received on the image of the examined area (Fig. 33A and 34A) and saved in the memory unit 2 by predetermined method. The accuracy of plotting of the thermogram depends on the number of points and distances between them: the more points are put in the selected area and the lesser distance is between them, the greater is the accuracy of plotting the thermogram. So, graphical indications of points for temperature measurement on the image of the examined area of human skin surface with the focus on the anatomical landmarks of that area are indicated in the amount, minimally sufficient for monitoring of any pathological process in this area.

Based on the results of the first examination session, some numerical indexes are detected automatically (for example, the maximal temperature difference between the points of the examined area, the area of the zones of hypo- and hyperthermia, thermograms of the examined area, and others; text conclusions that reflect the results of the analysis, for example, "Maximal thermo-asymmetry is 0.8 °C. The zone of hyperthermia is 26.5%" are automatically issued). However, the independent value of the data from the first session of the examination according to the claimed method and the device is small in the view of well-known low specificity of thermography. This data has added significance only for the specialist, not for common user, and only in conjunction with other clinical/paraclinical data determining an accurate diagnosis.

On the request of the user, the comparison of the results of measurements (temperature values in the same points of the template, obtained at different monitoring sessions and/or thermograms) is done starting from the second examination session in automatic mode, also, the analysis is conducted in accordance with pre-saves algorithms with the subsequent issuing of conclusions on the course of the pathologic process and/or the effectiveness of treatment, as well as with issuing to the user of the numerical indexes, text messages, audio messages, thermograms, graphs of temperature change.

The user can send the saved results of measurements through communication channels by using communication module 6.

Thus, after each session, the user receives the following information on the display of the device: numeric data, text and voice messages, thermograms, charts of temperature changes. Thus, partially automatic evaluation of pathological process and/or effectiveness of treatment by comparative analysis of temperature points of the template and/or thermograms is possible starting from the second session.

The method for monitoring of diseases by using the second version of the device for monitoring of diseases is carried out in the following way, the basic sequence of actions of the person or medical staff is described below.

In the first session of self-examination (examination), the image of the examined area of human skin surface is obtained from the camera of a Device of receiving, processing, saving, and displaying of information, and displayed on the Device screen in the form of a photographic image: Fig. 25B and 26B for examination and self-examination respectively. Alternatively, at the request of the user, 2D or 3D models of an area of human skin surface retrieved from the memory of the Device to the screen can be used as an image of the examined area. Shifting, rotation, and scaling of the image can be done on the Device screen. Graphical indications of points for temperature measurement are indicated on the image of the examined area, for example, by imposing the ready-made set of graphical indications of points, available in the program (from the Device memory, according to the program the processor is configured), or that template can be formed sequentially by hand (Fig. 27B and 28B). In case of the alignment of graphical indications of points by hand, the user is guided by the examples stored in the Device memory (or retrieved from an external source, for example, from the User's Manual); or, at the request of the user, the user is guided by doctor's recommendations or by telemedical technologies through communication channels. Images of the examined area with indicated graphical indications of points for temperature measurement are entered into the Device memory once to form a template that is stored in the Device memory for further use during the monitoring period. The saved template is retrieved from the Device in the repeated monitoring sessions.

The necessity to create, save, and use the new template (new photo image with the graphical indications of points for temperature measurement put on it) appears in case of the significant, for measurement accuracy, change in the appearance or size of the examined area (for example, decreasing swelling or wound healing) causing mismatch of the image of the area and the actual area.

Then, by using the remote module, the temperature in each point of the examination area of human skin surface is measured by (Fig. 29B and 3 OB), following which, information in the form of the temperature data at each point (Fig. 3 IB and 32B) is received. Measurement of temperature on the examination area in visual correlation with graphical indications of points on the template, displayed on the Device screen, is done repeatedly during the time interval chosen by the user. Measurement of the temperature at the points of the examined area is carried out with maximum unification of the distance and the angle (with minimal deviation from perpendicular) between the surface of examination area of skin and the infrared sensor by the tool for unification of temperature measurements, which is the component of the remote module and made, for example, in a form of a projection from a biologically neutral material around the hole, in which an infrared sensor is installed. The measurement results are saved in the Device memory and processed with the issuance of numeric indexes, audio, and text messages. Besides, based on the results of the measurements, thermogram is received on the image of the examined area (Fig. 33B and 34B) and saved in the Device memory by predetermined method. The accuracy of plotting of the thermogram depends on the number of points and distances between them: the more points are put in the selected area and the lesser distance is between them, the greater is the accuracy of plotting the thermogram.

Based on the results of the first examination session, some numerical indexes are detected automatically (for example, the maximal temperature difference between the points of the examined area, the area of the zones of hypo- and hyperthermia, thermograms of the examined area, and others; text conclusions that reflect the results of the analysis, for example, "Maximal thermo-asymmetry is 0.8 °C. The zone of hyperthermia is 26.5%" are automatically issued). However, the independent value of the data from the first session of the examination according to the claimed method and the device is small in the view of well-known low specificity of thermography. This data has added significance only for the specialist, not for common user, and only in conjunction with other clinical/paraclinical data determining an accurate diagnosis.

On the request of the user, the comparison of the results of measurements (temperature values in the same points of the template, obtained at different monitoring sessions and/or thermograms) is done starting from the second examination session in automatic mode, also, the analysis is conducted in accordance with pre-saves algorithms with the subsequent issuing of conclusions on the course of the pathologic process and/or the effectiveness of treatment, as well as with issuing to the user of the numerical indexes, text messages, audio messages, thermograms, graphs of temperature change.

Thus, after each session, the user receives the following information on screen: numeric data, text and voice messages, thermograms, charts of temperature changes. Thus, partially automatic evaluation of pathological process and/or effectiveness of treatment by comparative analysis of temperature points of the template and/or thermograms is possible starting from the second session.

For the claimed method for monitoring of diseases for using of any versions of the claimed device for monitoring of diseases the numerical indexes can be expressed in form of a great number of important indexes, including: maximal thermo-asymmetry in the examined area (maximal identified temperature difference in symmetrical points); maximal difference of the temperature in the examined area from the temperature in the comparison point; longitudinal gradient on the extremities (for example, temperature difference in the upper and lower thirds of a shin), for example, in Celsius; zone of hyper- or hypo-thermia in the percentage of the examined area (the relationship of the number of points with significant for the algorithm increased or decreased temperature in relation to the total number of points on the area under examination); the difference of temperature values in the same points of the template at previous measurements and measurements to be analyzed; other indexes.

With a purpose of increasing visualization, numerical figures (and text messages) can be presented in different colors on screen: for example, in green color in the case of compliance to the norm, in yellow color in the case of minor deviation from the norm, and in red in the case of significant deviation from the norm. In addition, for increasing of visualization, the graphs showing the changes of these indexes in dynamics can be plotted by the results of calculations of numerical indexes, for example, the graph of changes of the area of hyperthermia or hypothermia, the graph of changing the values of a point or points of maximum or minimum temperature, and others. This helps the patient to understand, for example, which medication out of several, taken during the monitoring period, acted on thermo signs of a disease more effectively. In a concise and accessible form, text messages tell the user information about the course of the disease, the effectiveness of the treatment, and recommended actions, such as "Thermo signs of negative dynamics" or "Thermo signs of positive dynamics. Local influence, mainly on the zone of hyperthermia is recommended."

Normal temperature range for some specified areas of skin surface is +/- 0.4 C and +/- 0.6 C for other specified areas of skin surface. The change of some quantitative vales of arithmetical mean of temperatures in all the points of the template or part of them in the specified quantitative interval at different monitoring sessions gives the grounds, including at processor's work, for making automatic conclusions, for instance, "Thermal signs of positive dynamics" or "Thermal signs of negative dynamics" or "Thermal signs are without change".

Together, numerical indexes, sound, and text messages provide the basic information to the user, which, in ordinary cases, is sufficient to make decisions without referencing to the specialist. Thermograms are needed for visualization of the size, shape, and location of pathologic center and their changes over time, as well as for precise choosing of the area for exposure.

Thermograms, superimposed on a photo image or picture of an examined area, show objective localization of pathologic center, which does not always coincide with the localization of pain and other subjective symptoms, which helps the user to make local therapeutic influence more targeted and effective. Also, thermograms show the relative position and shape of the areas of hyper- and hypothermia on the area under examination, which is important information for conducting telemedicine consultations. This visualization clearly and concisely displays the dynamics of the pathologic process in whole.

The first measurement of temperature of the points of template, including the option of plotting of thermogram, allows to receive automatic analysis with respect to peculiarities of the temperature distribution in the examined area. The use of the proposed method and the device for monitoring of diseases allows to receive and save two or more temperature values of the identical (same) points of the template of the same examination area at different monitoring sessions and their comparison in automatic mode, which increases the accuracy of monitoring of diseases, simplifies and reduces the cost of obtaining information about pathological process and/or about the effectiveness of treatment, in the form of conclusions and recommendations, in ordinary cases, without the participation of a specialist.

The claimed method, unlike the prototype, reveals the unobvious conditions of uniform temperature measurement, repeated many times in the same points of the template at different monitoring sessions on the examined area for the purpose of correct comparison of temperature values of points of the template in dynamics; the method also reveals the conditions for comparison of temperature values of points of the template and thermograms by technical means and software, namely, their plotting based on the image that was formed once with a set of points (template) that were placed there once; and the method by using of any variant of the device allows to receive a sequence of temperature values of the points of the template and thermograms that meet the following criteria: measurements of temperature are done at all points of the template and in each measuring session in compliance with using of the tool for unification of temperature measurements of any variant of the device for the examination area of human skin surface; the stated actions allow to compare the received temperature values of the points of the template and/or the thermogram correctly and in automatic mode; automatically make conclusions about the dynamics of the pathological process and/or the effectiveness of treatment and provide recommendations to the user.

The claimed in the invention device gives unobvious opportunity to maximally efficiently implement the claimed method. It has the advantages of contact thermometers, non-contact pyrometers, non-contact thermographs and does not have their drawbacks:

- Allows accurate positioning on the measurement point in each series of measurements by the use of the tool for providing the constant distance and angle between the examination area of the human body and an infrared sensor, which ensures compliance with the maximally unified distance and angle of the infrared sensor against the examination area of a human body, and prevention of the influence of air flows on the results temperature measurement of the body surface by the infrared sensor, and also prevention of direct contact of the infrared sensor with the skin surface, ensuring elimination of errors at measuring of skin surface.

- Has a fixed size of a view spot, and also provides the absence of measurement error or a low error due to maximum unification of the distance and angle between the infrared sensor and the examined surface in the series of temperature measurements.

- Combines high accuracy of temperature measurement with high speed of measurement through the use of radiation principle that allows, during one session, quickly to measure the temperature of the number of points sufficient to detect and monitor any pathology, associated with changes of local temperature of human skin surface and possible in the examined area, including in difficult to access areas, for example, areas covered by hair, behind the ears, inside the mouth, in the area of contractures, in skin folds, in body areas contacting each other or situated in close proximity (inter-finger spaces, etc.).

- Allows to measure temperature and store temperature values of the points of the template and/or thermogram that are necessary for further analysis, herewith, the unification of the procedure of measuring by the device provides the ability to use the same template for temperature measuring in repeated examinations and conduct correct comparison of the results of temperature measurements of the points of the template and/or thermogram taken at different times.

- Has the ability to implement any algorithms of analysis of temperature points of the template and/or thermograms and their comparisons, and display thermograms on the screen, the results of their comparison, conclusions, and recommendations to the user.

Developed for the first time, previously unknown and non-obvious combination of the above stated design features of a tool for unification of temperature measurements gave unexpected technical result of the claimed invention, namely, the possibility of correct measuring of temperature of the set of points on the surface of human skin during one monitoring session, possibility of correct measuring of the same set of points in the repeated monitoring sessions, and, as a result, the possibility of correct comparison of temperature values in the same points at different monitoring sessions.

So the above listed features cause to characterize the tool for unification of temperature measurements as the tool for ensuring of the absence of contact between the infrared sensor and the skin surface, ensuring constant distance and angle between the infrared sensor and the skin surface, protecting of the skin surface from the effects of air currents, made of material with low thermal conductivity and not changing the skin surface temperature during the contact of the tool with the skin surface. Described in the invention combination of design details that provide the technical result of the invention was not previously described neither at any combination of them, nor in the united complex, offered in the present invention.

The possible insignificant changes of temperature at repeated measurements in points, obtained with the tool for ensuring of the absence of contact between the infrared sensor and the skin surface, ensuring constant distance and angle between the infrared sensor and the skin surface, protecting of the skin surface from the effects of air currents, made of material with low thermal conductivity and not changing the skin surface temperature during the contact of the tool with the skin surface, not connected with the choice of specific infrared sensor (for instance, within 0.1-0.2 C ) do not influence the technical result of the invention. It is a consequence of the fact that there is a normal range of temperature deviations for any monitoring areas of skin surface, deviation from such range is always larger than the possible error.

Measurements of skin surface temperature, carried out without any constructive component of the tool for ensuring of the absence of contact between the infrared sensor and the skin surface, ensuring constant distance and angle between the infrared sensor and the skin surface, protecting of the skin surface from the effects of air currents, made of material with low thermal conductivity and not changing the skin surface temperature during the contact of the tool with the skin surface, or without complying with the requirement for the type of material of the tool, or without any combination or one of the components of the tool, or without using the tool, are incorrect and significantly exceed the normal range of temperature deviations for any monitoring areas of the human skin surface. This significantly influences the precision of monitoring results, making them incorrect.

New and non-obvious technical solution of the invention of united design of the tool for ensuring of the absence of contact between the infrared sensor and the skin surface, ensuring constant distance and angle between the infrared sensor and the skin surface, protecting of the skin surface from the effects of air currents, made of material with low thermal conductivity and not changing the skin surface temperature during the contact of the tool with the skin surface, which is included in any version of the device for monitoring of diseases, united five absolutely different and partially opposite technical solutions, namely:

- Protection of the skin surface of air currents, which prevents accidental changes of the temperature of the skin surface in any way of temperature measurement, including one time measurement.

- Providing the constant angle between the infrared sensor and the skin surface, which is important only for unification of repeated temperature measurements of the set of points in one monitoring session and in different monitoring sessions, but not important for one time measurement.

- Providing the constant distance between the infrared sensor and skin surface, which is important only for unification of repeated temperature measurements of the set of points in one monitoring session and in different monitoring sessions, but not important for one time measurement.

- Providing the absence of contact of infrared sensor and skin surface for any version of temperature measurement, including one time measurement, in other words, providing non-contact temperature measurement in the conventional sense. - Providing the absence of cooling or heating of the skin surface through the use of the tool's material with low thermal conductivity at contact measurement in the conventional sense.

Unexpected combined effect from the united use of five different technical solutions in one design is many times more than in case of their separate use or their use in any other combination, except the united use, claimed in the invention.

Unexpected combined effect from the united use of five different technical solutions in one whole technical solution is many times more than in case of their separate use or their use in any other combination, except the united use, claimed in the invention.

Such simple, but non-obvious technical solution led to the unexpected technical result, namely, to high precision of temperature measurement of skin surface, including in multiple temperature measurements of points in one session as well as in repeated monitoring sessions.

The developed technical solution of the tool for ensuring of the absence of contact between the infrared sensor and the skin surface, ensuring constant distance and angle between the infrared sensor and the skin surface, protecting of the skin surface from the effects of air currents, made of material with low thermal conductivity and not changing the skin surface temperature during the contact of the tool with the skin surface, allows the user with normal manual abilities to measure temperature correctly, in other words, by means of contact pressing of the tool for unification against the skin surface in the position that is close to perpendicular.

The invented device can be used for maximum possible precise measurement of the temperature of skin surface by any means, including at onetime measurements, however, its advantages are more relevant for achieving the technical result of the present invention.

Thus, the combined use of the claimed method and the device gives a previously unknown, non-obvious and unexpected synergistic effect that is apparent in the possibility for the user by himself and without participation of the specialist to conduct monitoring of pathologic process and receive verbal evaluation of the process dynamics in partially automatic mode, accompanied by thermograms that visually demonstrate the changes of the temperature of the skin surface in the projection of the pathologic center. Such possibility is provided by previously unused combination of the sequence of actions according to the claimed method and technical solution features of the claimed device, namely, the use of the once plotted template with indicated on it points for temperature measurement in all monitoring sessions, and using at the device's design a tool for ensuring of the absence of contact between the infrared sensor and the skin surface, ensuring constant distance and angle between the infrared sensor and the skin surface, protecting of the skin surface from the effects of air currents, made of material with low thermal conductivity and not changing the skin surface temperature during the contact of the tool with the skin surface. As a result, high reproducibility of the results of self-examination procedure and the results of temperature measurement at each measurement of the set of points during one monitoring session and every monitoring session, which guarantees the absence or minimal (not influencing on monitoring results) error when measuring temperature, and therefore, guarantees sufficient precision and correctness of self-examination by a user without special training and correctness of automatic or partially automatic interpretation of results.

The examples of the specific use of the claimed method and the device are presented below. For the goal of testing of both versions of method and device users were supported with the first version of the device and the second version of the device.

Example 1.

Patient K., 29 years old, was sent by general practitioner to consult a therapist otolaryngologist. The patient complained of persistent, intense, pulsating pain in the left maxillary sinus projection, pains were more intense in the cold air, stuffiness in the left side of the nose was present as well as purulent discharge from the left nasal duct, headache, weakness, and increase of body temperature to 37.8°C.

The patient connects the beginning of the disease with over exposure to cold. The anamnesis includes the surgery of removing a deviated nasal septum in the year 2000. The patient was treated for right-side sinusitis and right maxillary sinus cyst in 2003. 2 weeks ago the patient was treated by a dentist.

Otolaryngologist stated satisfactory condition of the patient during examination. The nose had the usual form. Skin covers the nose were flesh-colored with normal humidity. Breathing through the right nostril was free; breathing through the left nostril was is difficult. The sense of smell was not changed. Slight hyperemia and mild swelling of the skin in the area of projection of the left maxillary sinus was present. Palpation of nose was painless. Painfulness was revealed at palpation of the area of projection of the left maxillary sinus.

Anterior rhinoscopy: nasal vestibule is free from the right and from the left. Nasal mucosa on the right is pink, smooth, moderately moist, conchas are not increased, lower and general nasal ducts are free. The nasal septum is in the midline and does not have significant distortions. Nasal mucosa on the left is hyperemic, edematous, conchas are enlarged, accumulation of purulent secretions in general and mostly in the middle nasal duct, flowing down from under the middle concha is revealed.

Postnasal rhinoscopy: choanae and nasopharynx vault are free, the mucosa of the pharynx and conchas is pink, smooth, the rear ends of shells do not go out of choanae, vomer is in the midline. The entrances of the auditory tubes are closed.

Clinical blood analysis: erythrocytes: 4, 18x1012/1, Hb: 26 g/1, color index: 0.95, leukocytes: 10,2xl0⁹/l (young neutrophils: 1%, stab neutrophils: 3%, segmented neutrophils: 70%, lymphocytes: 25%, monocytes: 1%), ESR: 25 mm/h.

X-ray examination: horizontal fluid level is in the left maxillary sinus. Ethmoidal labyrinth's cells are visualized. Frontal sinus is pneumotized.

Based on the anamnesis, physical examination, and the data from additional methods of examination the patient was diagnosed with acute left-sided sinusitis. The following treatment was assigned: vasoconstrictive agent (Naphazoline - nasal drops), antibiotic therapy (Cefotaxime intramuscularly).

For observing the dynamics of the inflammatory process the patient was asked to carry out infrared thermography of the face of the projection of the maxillary sinuses every other day by using the first and second version of the device.

Using the first version of the device, the patient obtained photographic image of face by using the device and manually indicated the graphical indications of points for temperature measurement on the image displayed on screen.

Using the second version of the device, the patient obtained photographic image of face by using the web-camera of personal computer and manually indicated the graphical indications of points for temperature measurement on the image displayed on screen.

The graphical indications of points were placed at a distance between one another, corresponding to about 1 cm on the face; the graphical indications of points were placed on the photographic image of the face in the area of projections of maxillary sinuses and on the nose (Fig. 35).

For comfort finding of points on face and for more correct temperature measurements the patient was seeing to the mirror during the measurements of the temperature at first monitoring session.

Using the first version of the device, the patient measured skin temperature with the help of the additional module by looking at the screen of the device.

Using the second version of the device, the patient measured skin temperature with the help of the infrared sensor of the remote module, which was operationally coupled with the personal computer by wireless connection, and by looking at the screen of the personal computer.

The temperature was measured sequentially point by point and the point for measurement was highlighted in red on the screen (shown in Fig. 35 by an arrow). Temperature values were obtained in each of the measured points, thermogram was plotted automatically, which is shown in Fig. 36. Expressed thermal asymmetry and hyperthermia in the area of left maxillary sinus is visible on the thermogram. The software automatically made the following conclusion: "The maximum thermal asymmetry is 2.5°C. The zone of hyperthermia is 37.5%" (note: the letters are in red).

A day later, the patient conducted second self-examination and received thermogram shown in Fig. 37. After comparing it with the first values of temperature measurements, the following conclusion was automatically generated: "The maximum thermal asymmetry is 1.6°C. The zone of hyperthermia is 25%. Thermal signs of positive dynamics".

Repeated self-examination gave the thermogram presented on Fig. 38. After comparing it with the previous thermograms, the following conclusion was automatically generated: "The maximum thermal asymmetry is 1.4°C. The zone of hyperthermia is 25%. Thermal signs of positive dynamics are absent" (note: the letters are in red).

The patient came to the repeated reception of otolaryngologist on the following day. According to the patient's words, pain persistence has decreased to moderate, body temperature has decreased to 37.0-37.4°C, fatigue has decreased as well. However, congestion of nose on the left and purulent discharge from the left nasal duct was still present. The physician additionally assigned therapeutic puncture of the left maxillary sinus with furatsillin solution lavage.

After two punctures, a thermogram was obtained, as shown in Fig. 39. After comparing it with the previous thermogram, the following conclusion was automatically generated: "The maximum thermal asymmetry is 1.0°C. The zone of hyperthermia is 18.75%. Thermal signs of positive dynamics" (note: the letters are in yellow).

The patient has been taking antibiotics during one more week, and complete clinical recovery was achieved, which was evidenced by several thermograms, the last of which is presented in Fig. 40, as well as by the graph of the dynamics of maximum thermal asymmetry, shown in Fig.41. The program (corresponding to which the processor is configured) automatically generated the following conclusion: "The maximum thermal asymmetry is 0.4°C. The zone of normal- thermia is 100%. Thermal signs of positive dynamics" (note: the letters are in green).

Example 2.

Patient N., 50 years old, has been a patient of rheumatologist for 15 years on the account of osteoarthritis of the left knee of traumatic origin. According to X- ray examination: narrowing of the joint space due to the destruction of cartilage, subchondral osteosclerosis, osteophytes, cyst restructuring epiphyses of the left knee joint.

The patient has the first and the second version of the device for monitoring of the status of knee joints at home. The patient conducts self-examination of the knee one to two times a month during the remission period, ones a week in autumn and winter period, and daily in case of aggravations.

Using the first version of the device, the photo image of the knee joint has been previously made and added in the database of the device. Using the second version of the device, the photo image of the knee joint has been previously made by the camera of mobile phone and added in the database of the mobile phone. The photo images was obtained after the patient has indicated centers of kneecaps by a marker as directed in the manual (Fig. 42).

The grid with graphical indications of points for temperature measurement (template) was overlaid on the photo image, herewith, the central graphical indications of points (marked by arrows) were aligned with the centers of the knee caps (Fig. 43). First thermogram is shown in Fig. 44. The program automatically generated the following conclusion: "The maximum thermal asymmetry is 0.8°C. The zone of hyperthermia on the left is 8.3%" (note: the letters are in yellow).

After inadequate for this patient exercise, severe pain has appeared in the left knee as well as limited mobility, painfulness at palpation, which was more expressed on the outer surface of the knee, and a sense of "crunch" during the motion in the joint. The conducted self-examination with the proposed device showed the thermogram, presented in Fig. 45. After comparing it with the previous thermogram, the following conclusion was generated automatically: "The maximum thermal asymmetry is 1.8 °C. The zone of hyperthermia is 19.4% from left and 2.7% from the right. Thermo signs of negative dynamics. Local medical influences, mainly in the zone of hyperthermia, are recommended" (note: the letters are in red). The patient began to implement the treatment, which was prescribed to her before: anti-inflammatory medications and chondroprotectors (Diclofenac-Gel locally in the zone of hyperthermia, Theraflex and HARPASUL Natysal Forte inside). Conducted in one week self-examination revealed the result shown in Fig. 46.

After comparing it with the previous thermogram, the following conclusion was automatically generated: "The maximum thermal asymmetry is 1.4°C. The zone of hyperthermia on the left is 14%», on the right is 2.7%. Thermo signs of positive dynamics. Local influence mainly on the area of hyperthermia is recommended" (note: the letters are in yellow).

The patient continued the treatment, and the thermogram shown in Fig.47 was obtained one more week later. After comparing it with the previous thermograms the following conclusion was automatically generated: "The maximum thermal asymmetry is 1.0°C. The zone of hyperthermia on the left is 1 1%, and on the right is 2.7%. Thermo signs of positive dynamics. Local influence mainly on the area of hyperthermia is recommended" (note: the letters are in yellow).

The patient continued the treatment, and the thermogram shown in Fig.48 was obtained one more week later. After comparing it with the previous thermogram the following conclusion was automatically generated: "The maximum thermal asymmetry is 0.6°C. The zone of hyperthermia on the left is 2.8%. Thermo signs of positive dynamics" (note: the letters are in green).

Example 3.

Patient B., 40 years old, suffer from varicose veins of the lower extremities for 10 years, varicose is more expressed on the left and appeared during pregnancy. Clinical diagnosis: Varicose veins of the lower extremities. Chronic venous insufficiency of 1 -2 degree. Patient takes estrogen-containing contraceptives.

The patient has the first and the second version of the device at home for the purpose of monitoring the condition of veins of lower extremities. The patient usually does self-examination of legs 1 to 2 times per month.

Using the first version of the device, the photo image of the back sides of shanks has been previously made and added in the database of the device. Using the second version of the device, the photo image of the back sides of shanks has been previously made by the camera of smartphone and added in the database of the smartphone.

The grid with graphical indications of points for temperature measuring was superimposed on the photo image (Fig. 49).

The first thermogram is shown in Fig. 50. The following conclusion was automatically generated by the program: "The maximum thermal asymmetry is 0.6°C. Longitudinal gradient on the left is 1°C and 0.8°C on the right" (note: the letters are in green).

Severe pain in the upper third of the back side of the left shank has appeared after the minor injury, painfullness along the vein at palpation was present. Self- examination has shown the thermogram, presented on Fig. 51. After comparing it with the previous thermogram, the following conclusion was automatically generated by the program: "The maximum thermal asymmetry is 1.8°C. The zone of hyperthermia on the left is 25%. Longitudinal gradient on the left is 0°C, and 0.8°C on the right. Thermo signs of negative dynamics. Local medical influences are recommended mainly in the zone of hyperthermia" (note: the letters are in red).

The patient has forwarded all the results of self-examination to the doctor through the claimed device for receiving telemedicine consultation. The doctor of telemedical center conducted online consultation, including with the use of the claimed device, listened to the complaints of the patient, analyzed the results of self-examination, and examined the sore leg of the patient by using the photo image made by the photo camera of the device and sent to him. Examination showed redness above the varicose vein in the upper third of the left shank and small swelling of the left shank. The doctor stated the following diagnosis: acute thrombophlebitis of superficial vein of the left shin. The doctor made the following prescriptions: bed rest, withdrawal of contraceptives, application of heparin- containing gel (Lioton 1000) topically to the area of hyperthermia, non-steroidal anti-inflammatory medications (Diclofenac, to be consumed internally), venotonics (Troxerutin, to be consumed internally).

Three days after the start of treatment, the patient has done self-examination and received a thermogram shown in Fig. 52. After comparing it with the previous thermogram, the following conclusion was automatically generated: "The maximum thermal asymmetry is 1.0°C. The zone of hyperthermia on the left is 20%. Longitudinal gradient is 0.4°C on the left and 0.8°C on the right. Thermo signs of positive dynamics. Local influence mainly in the zone of hyperthermia is recommended " (note: the letters are in yellow).

The patient continued the treatment, and one week later she obtained a thermogram shown in Fig.53. After comparing it with the previous thermogram the following conclusion was automatically generated: "The maximum thermal asymmetry is 0.6°C. Longitudinal gradient is 0.8°C on the left and 0.8°C on the right. Thermo signs of positive dynamics" (note: the letters are in green).

Example 4.

Athlete I. (sprinter), age 20, uses the first and second versions of the device to monitor the process of warming up of muscles. Usually he does self- examination or examination with the help of a coach in the projection of muscles of the back side of the thigh.

The patient does temperature monitoring of the back group of muscles of the thigh because he had a minor injury in this area three years ago. This group of muscles has a big load, because these muscles have a role of muscle brakes and they must stop the movement of the leg going forward, exactly at the specific point of time. After the usual warm-up, the temperature of the muscles of the front surface of the thigh is much higher than the initial temperature, at the same time, the temperature of the muscles of the back side of the thigh remains unchanged. The fact is that quadriceps muscle of thigh and gastrocnemius muscle warm up the most, not the muscles of the back side of the thigh. Therefore, they get into maximal work practically unprepared, which leads to injury. Special exercises and self-massage should be done for their warm-up.

The image of the back sides of thighs with the graphical indications of points indicated on it was previously added to the database of the first version device, and to the memory of the smartphone functionally coupled to the remote module with infrared sensor (the second version, used by the patient I.); the graphical indications of points are the templates for temperature measurement are shown in Fig.54. Before starting the warm-up, the athlete measured the temperature according to the template. The program has automatically generated the following conclusion: "The maximum thermal asymmetry is 0.4°C. Average temperature is 30.4°C on the left and 30.8°C on the right" (note: the letters are in green). During 10 minutes after the warm-up, the athlete measured the temperature again, according to the template, and compared the results with previous ones. The program has automatically generated by the following conclusion: "The maximum thermal asymmetry is 0.4°C. Average temperature on the left is 31.2°C and 31.6°C on the right. Insufficient warm-up of muscles" (note: the letters are in green, and the last sentence is in yellow). The athlete was warming up for 5 more minutes, by doing special exercises to warm up the back group of muscles of the thigh and self- massage. He measured the temperature again, according to the template, and compared the results to those that came before the warm up. The program automatically generated the following conclusion: "The maximum thermal asymmetry is 0.4°C. Average temperature on the left is 32.4°C and 32.6°C on the right. Sufficient warm-up of muscles" (note: the letters are in green).

Example 5.

Woman B., 30 years old, with initial manifestations of cellulite, started a course of treatments, while, for the purpose of objective monitoring of their effectiveness, she used the first and second versions of the device as directed to control the effectiveness of treatment of cellulite. Before the first treatment, the problem area was photographed by the women's husband, he used the camera of the first version of the device and camera of tab, operatively connected with remote module for the second version. Then, she manually put the graphical indications of points on the image and saved the received template for temperature measurement, the template is shown in Fig.55.

Then, she measured the temperature at each point in visual correlation with the graphical indications of points on the image. Measurements were made by the additional module of the first version of the device or using remote module for the second version. She received a thermogram presented in Fig.56. Also, the program automatically generated the following conclusion: "The maximum temperature is 28.8°C, the minimum temperature is 26.2°C, the average temperature is 27.5°C. The zone of hypothermia is 36.6%" (note: the letters are in red).

Before the beginning of the second treatment session, she measured temperature again according to the saved template of points' layout on the problem area. The thermogram shown in Fig.57 was obtained.

The program (corresponding to which the processor is configured) automatically generated the following conclusion: "The maximum temperature is 29°C, the minimum temperature is 26.8°C, the average temperature is 28°C. The zone of hypothermia is 31.7%" (note: the letters are in yellow). Thus, minimum and average temperature in the problem area has increased and the area of hypothermia has reduced. According to the manual on monitoring of the effectiveness of treatment of cellulite, it is a sign of correctly chosen therapy. The client has decided to complete the entire course of treatments. Before the beginning of the last treatment, she measured the temperature again, according to the saved template. The thermogram shown in Fig.58 was obtained. The program automatically generated the following conclusion: "The maximum temperature is 32.2°C, the minimum temperature is 31.2°C, the average temperature is 31.7°C. The zone of normal-thermia is 100%" (note: the letters are in green). Thus, it has objectified the improvement of blood circulation in the problem area, which is one of the main criteria for successful treatment of cellulite.

Claims

1. A method of monitoring temperature variations of an area of the human skin surface, the method comprising the steps of: recording in a memory unit an image of an area of the human skin surface, displaying on a screen the image together with indications of points for temperature measurements to be obtained, obtaining temperature measurements during a monitoring session in points on the area of the human skin surface corresponding with the indicated points displayed on a screen, saving in the memory unit the obtained temperature measurements for each point on the area of the human skin surface, characterized by repeating at intervals during the monitoring period the steps of obtaining the temperature measurements from the points of the area of the human skin surface corresponding with the indicated points displayed on the screen, and saving the obtained temperature measurements for each point on the area of the human skin surface in the memory unit, comparing the temperature measurements obtained during different monitoring sessions from the same points on the area of the human skin surface, and determining and saving in the memory unit monitoring result based on the comparison, wherein the same image of the area of the human skin surface and the same indications of the points for temperature measurements are displayed on the screen during each monitoring session of the monitoring period when the temperature measurements are obtained.

2. The method of claim 1 is carried out by the device formed from a set of components comprising: a memory unit, a screen, a camera, an infrared sensor, a tool for ensuring of the absence of contact between the infrared sensor and the skin surface, ensuring constant distance and angle between the infrared sensor and the skin surface, protecting of the skin surface from the effects of air currents, made of material with low thermal conductivity and not changing the skin surface temperature during the contact of the tool with the skin surface, control buttons, a power supply, a communication module, a processor connected to the memory unit, screen, infrared sensor, camera, communication module, control buttons, power supply; and a case.

3. The method according of claim 2, wherein the case houses the set of components.

4. The method according of claim 3 wherein the additional infrared sensor, the additional tool for ensuring of the absence of contact between the infrared sensor and the skin surface, ensuring constant distance and angle between the infrared sensor and the skin surface, protecting of the skin surface from the effects of air currents, made of material with low thermal conductivity and not changing the skin surface temperature during the contact of the tool with the skin surface, the additional power supply, the additional communication module, the additional control buttons, and the additional processor are formed in a separate case as an additional module, which is operatively coupled to the device comprising a memory unit, a screen, a camera, an infrared sensor, a tool for ensuring of the absence of contact between the infrared sensor and the skin surface, ensuring constant distance and angle between the infrared sensor and the skin surface, protecting of the skin surface from the effects of air currents, made of material with low thermal conductivity and not changing the skin surface temperature during the contact of the tool with the skin surface, control buttons, a power supply, a communication module, a processor connected to the memory unit, screen, infrared sensor, camera, communication module, control buttons, and power supply.

5. The method according of claim 2, wherein the infrared sensor, the tool for ensuring of the absence of contact between the infrared sensor and the skin surface, ensuring constant distance and angle between the infrared sensor and the skin surface, protecting of the skin surface from the effects of air currents, made of material with low thermal conductivity and not changing the skin surface temperature during the contact of the tool with the skin surface, the power supply for remote module, the communication module for remote module, the control buttons for remote module and the processor for remote module are formed in a separate case as a remote module, which is operatively coupled to a set of allocated in another separate case components comprising at least a communication module, a processor, a power supply, control buttons, a memory unit, a screen, and a camera.

6. The method according to any of the claims 2 to 5, wherein at least two infrared sensors with the tools for ensuring of the absence of contact between the infrared sensor and the skin surface, ensuring constant distance and angle between the infrared sensor and the skin surface, protecting of the skin surface from the effects of air currents, made of material with low thermal conductivity and not changing the skin surface temperature during the contact of the tool with the skin surface are allocated in the device.

7. The method according to any of the previous claims, wherein the result is an indication of changes in a temperature gradient across the area of the human skin surface between monitoring sessions.

8. The method according to any of the previous claims, wherein the results of the monitoring are generated in the form of a text message.

9. The method according to any of the previous claims, wherein the results of the monitoring are generated in the form of a thermogram.

10. Device for monitoring temperature variations on an area of the human skin surface, the device comprising a set of components comprising: a memory unit, a screen, a camera, an infrared sensor, a tool for ensuring of the absence of contact between the infrared sensor and the skin surface, ensuring constant distance and angle between the infrared sensor and the skin surface, protecting of the skin surface from the effects of air currents, made of material with low thermal conductivity and not changing the skin surface temperature during the contact of the tool with the skin surface, control buttons, a power supply, a communication module, a processor connected to the memory unit, screen, infrared sensor, camera, communication module, control buttons, power supply; and a case.

1 1. The device of claim 10, wherein the processor is configured to: record in the memory unit an image of an area of the human skin surface obtained from the camera, display on the screen the image together with indications of points for temperature measurements to be obtained, obtain from the infrared sensor during a monitoring session temperature measurements from the points on the area of the human skin surface corresponding with the indicated points, displayed on a screen, saving in the memory unit the obtained temperature measurements for each point on the area of the human skin surface, repeat at intervals during a monitoring period the steps of obtaining the temperature measurements from the points on the area of the human skin surface corresponding with the indicated points, displayed on the screen, and saving in the memory unit the obtained temperature measurements for each point on the area of the human skin surface, compare the temperature measurements obtained during different monitoring sessions from the same points on the area of the human skin surface, and determine and saving in the memory unit a result based on the comparison, wherein the same image of the area of the human skin surface and the same indications of the points for temperature measurements are displayed on the screen during each monitoring session of the monitoring period when the temperature measurements are obtained.

12. The device according to any of the claims 10 to 1 1, wherein the case houses the set of components.

13. The device of claim 12, wherein the additional infrared sensor, the additional tool for ensuring of the absence of contact between the infrared sensor and the skin surface, ensuring constant distance and angle between the infrared sensor and the skin surface, protecting of the skin surface from the effects of air currents, made of material with low thermal conductivity and not changing the skin surface temperature during the contact of the tool with the skin surface, the additional power supply, the additional communication module, the additional control buttons, and the additional processor are formed in a separate case as an additional module, which is operatively coupled to the device comprising a memory unit, a screen, a camera, an infrared sensor, a tool for ensuring of the absence of contact between the infrared sensor and the skin surface, ensuring constant distance and angle between the infrared sensor and the skin surface, protecting of the skin surface from the effects of air currents, made of material with low thermal conductivity and not changing the skin surface temperature during the contact of the tool with the skin surface, control buttons, a power supply, a communication module, a processor connected to the memory unit, screen, infrared sensor, camera, communication module, control buttons, and power supply.

14. The device according to any of the claims 10 to 1 1 , wherein the infrared sensor, the tool for ensuring of the absence of contact between the infrared sensor and the skin surface, ensuring constant distance and angle between the infrared sensor and the skin surface, protecting of the skin surface from the effects of air currents, made of material with low thermal conductivity and not changing the skin surface temperature during the contact of the tool with the skin surface, the power supply for remote module, the communication module for remote module, the control buttons for remote module and the processor for remote module are formed in a separate case as a remote module, which is operatively coupled to a set of allocated in another separate case components comprising at least: a communication module, a processor, a power supply, control buttons, a memory unit, a screen, and a camera.

15. The device according to any of the claims 10 to 14, wherein the device has at least two infrared sensors with the tools for ensuring of the absence of contact between the infrared sensor and the skin surface, ensuring constant distance and angle between the infrared sensor and the skin surface, protecting of the skin surface from the effects of air currents, made of material with low thermal conductivity and not changing the skin surface temperature during the contact of the tool with the skin surface.