WO2014070045A1 - Méthode et dispositif pour la surveillance de maladies - Google Patents

Méthode et dispositif pour la surveillance de maladies Download PDF

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Publication number
WO2014070045A1
WO2014070045A1 PCT/RU2013/000967 RU2013000967W WO2014070045A1 WO 2014070045 A1 WO2014070045 A1 WO 2014070045A1 RU 2013000967 W RU2013000967 W RU 2013000967W WO 2014070045 A1 WO2014070045 A1 WO 2014070045A1
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WIPO (PCT)
Prior art keywords
skin surface
infrared sensor
temperature
monitoring
screen
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PCT/RU2013/000967
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English (en)
Inventor
Yury Aleksandrovich Tkachenko
Yuliya Pavlovna Potekhina
Igor Evgenievich Davydov
Margarita Vladimirovna Golovanova
Roman Aleksandrovich Plokhov
Dmitriy Andreevich GOLOVACHEV
Original Assignee
Zakrytoe Aktsionernoe Obshchestvo "Cem Tehnolodzhi"
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Publication date
Priority claimed from RU2012146179/14A external-priority patent/RU2545423C2/ru
Priority claimed from RU2013112804/14A external-priority patent/RU2013112804A/ru
Application filed by Zakrytoe Aktsionernoe Obshchestvo "Cem Tehnolodzhi" filed Critical Zakrytoe Aktsionernoe Obshchestvo "Cem Tehnolodzhi"
Publication of WO2014070045A1 publication Critical patent/WO2014070045A1/fr

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/01—Measuring temperature of body parts ; Diagnostic temperature sensing, e.g. for malignant or inflamed tissue

Definitions

  • 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.
  • 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
  • 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.
  • 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.
  • 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;
  • Contact thermometers are devices for measurement of temperature of objects by direct contact of skin surface and temperature sensor.
  • 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:
  • thermometers provide high repeatability of results in measurement series as they have direct contact with the examined object.
  • contact thermometer has significant shortcomings that prevent its use in the context of the invention, namely:
  • thermo-radio-vision modern methodological approach: Monograph. - Nizhniy Novgorod: FGU "NNIITO Russian Medical Technologies", 2008. - 184 p. (p. 70-71)).
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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);
  • 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.
  • pyrometer measures the average temperature in a circular area with the diameter ranging from a few centimeters to tens of centimeters.
  • 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;
  • thermograms 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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;
  • thermograph measures the temperature based on radiation principle and constructs a thermogram almost instantly
  • thermogram • some models allow to impose the received thermogram on the photographic picture of the object at the moment of measurement.
  • 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.
  • the patient 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.
  • 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;
  • thermo 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.
  • 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.
  • thermographs are:
  • thermograph • high cost of a thermograph and the need for its regular maintenance.
  • 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.
  • 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.
  • 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.
  • diseases inflammatory, neoplastic, vascular, degenerative
  • thermography diagnostics are based on the comparison of thermograms of patients with averaged norm from the accumulated database.
  • 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.).
  • 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.
  • thermographs 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.
  • 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.
  • thermograms can be hardly comparable, and automatic analysis becomes impossible due to the impossibility to compare the thermograms obtained at different times.
  • 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 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.
  • the method by the prototype is not sufficient for monitoring of diseases for the following reasons:
  • 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);
  • 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.
  • thermograms 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.
  • 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.
  • thermograms are 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).
  • thermograms 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 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.
  • 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.
  • 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
  • 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.
  • 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.
  • the method is carried out by the device, the set of its components is housed in the case (hereinafter "the first version").
  • 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.
  • 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.
  • 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.
  • template The resulting image with indicated graphical indications of points hereinafter is referred to "template”.
  • graphical indications of points for temperature measurement can be indicated on the examined area of the image, being obtained from the memory unit.
  • graphical indications of points for temperature measurement can be indicated on the examined area of the image manually.
  • 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.
  • the image of the examined area can be made in the form of photographical image.
  • the image of the examined area can be made in the form of model 2D (two-dimensional) or 3D (three-dimensional) image.
  • the monitoring results can be generated in a form of a text message.
  • the monitoring results can be generated in a form of a graphic message.
  • the monitoring results can be generated in a form of an audio message.
  • the result can be an indication of changes in a temperature gradient across the area of the human skin surface between monitoring sessions.
  • the monitoring results of the monitoring can be generated in the form of a thermogram.
  • the result can include an indication whether the temperature gradient is within the predefined value range.
  • a device for monitoring temperature variations on an area of the human skin surface 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.
  • 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
  • the case houses the set of the device components (hereinafter "the first version”).
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • screen can be made touch-sensitive.
  • sensor of the screen can be made on resistive or capacitive matrix.
  • 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.
  • 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.
  • infrared sensor can be made, for example, on the basis of sensor MLX90614.
  • communication module can be made wire communication unit.
  • communication module can be made wireless communication unit.
  • wireless communication unit can be made by using standard solutions, such as, for example, GPRS, IEEE 802.1 1 , 802.15, etc.
  • power supply can be made battery.
  • battery can be made, in the form of Li-ion or Ni- Cd battery.
  • 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.
  • a tool for unification of temperature measurements can be made in a form of a protuberance, for example, from treated ABS plastic.
  • the protuberance can be made, for example, from hypoallergenic plastic made of polyurethane.
  • the protuberance can be made, for example, cylindrically.
  • hollow metal truncated cone with open ends 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.
  • 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.
  • the device for monitoring of diseases can have a function of changing the assignments of buttons when using right or left hand.
  • case can be made of plastic.
  • 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).
  • 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.
  • 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;
  • 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 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;
  • 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.
  • 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.
  • 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.
  • additional holes can be made in case 10, the number of holes will correspond to the number of sensors 4.
  • 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.
  • 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.
  • 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.
  • 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.
  • the infrared sensor 4 and camera 5 can be placed at opposite ends, or at opposite sides of the case 10.
  • one-time holders inserted after assembly can be used in the case 10 for mounting of electronic components.
  • 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.
  • 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.
  • 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.
  • the processor 1 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.
  • 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.
  • buttons can have a function reassignment of buttons' functions.
  • 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
  • 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.
  • 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.
  • remote display Fig. 22
  • 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 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.
  • 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.
  • 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.
  • 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 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.
  • 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.
  • 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).
  • 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.
  • the comparison of the results of measurements 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.
  • the user receives the following information on the display of the device: numeric data, text and voice messages, thermograms, charts of temperature changes.
  • numeric data text and voice messages
  • thermograms charts of temperature changes.
  • 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.
  • 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.
  • 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).
  • 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 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.
  • 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.
  • 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).
  • 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.
  • the comparison of the results of measurements 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 receives the following information on screen: numeric data, text and voice messages, thermograms, charts of temperature changes.
  • numeric data text and voice messages
  • thermograms charts of temperature changes.
  • 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.
  • numerical figures 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.
  • 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.
  • 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".
  • 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.
  • 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 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:
  • 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.
  • thermograms 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • X-ray examination horizontal fluid level is in the left maxillary sinus. Ethmoidal labyrinth's cells are visualized. Frontal sinus is pneumotized.
  • vasoconstrictive agent Naphazoline - nasal drops
  • antibiotic therapy Cefotaxime intramuscularly
  • 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.
  • 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.
  • 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).
  • the patient measured skin temperature with the help of the additional module by looking at the screen 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.
  • 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).
  • 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.
  • 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).
  • 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.
  • 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.
  • the photo image of the knee joint has been previously made and added in the database 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).
  • 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).
  • Fig. 46 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.
  • 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).
  • 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).
  • 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.
  • 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.
  • the photo image of the back sides of shanks has been previously made and added in the database 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.
  • thermogram The first thermogram is shown in Fig. 50.
  • thermogram 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).
  • thermogram shown in Fig. 52.
  • 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).
  • 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).
  • 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.
  • 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.
  • 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.
  • 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).
  • 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).
  • 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).

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  • Life Sciences & Earth Sciences (AREA)
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  • Medical Informatics (AREA)
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  • Pathology (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Physics & Mathematics (AREA)
  • Molecular Biology (AREA)
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  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
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  • Measuring And Recording Apparatus For Diagnosis (AREA)

Abstract

Le groupe d'inventions concerne la médecine, des mesures à des fins diagnostiques obtenues par mesure de la température d'une zone de surface de peau humaine, ainsi qu'une méthode et un dispositif pour la surveillance de maladies. La méthode de surveillance de maladies comprend les étapes qui consistent : à enregistrer dans une unité de mémoire une image d'une zone de surface de peau humaine ; à afficher sur un écran l'image avec des indications de points pour des mesures de température à obtenir ; à obtenir des mesures de température pendant une session de surveillance dans des points sur la zone de surface de peau humaine correspondant aux points indiqués affichés sur un écran ; à sauvegarder dans l'unité de mémoire les mesures de température obtenues pour chaque point sur la zone de surface de peau humaine, les étapes d'obtention des mesures de température à partir des points de la zone de surface de peau humaine correspondant aux points indiqués affichés sur un écran et de sauvegarde des mesures de température obtenues pour chaque point sur la zone de surface de peau humaine dans l'unité de mémoire étant répétées à intervalles définis pendant la période de surveillance ; à comparer les mesures de température obtenues pendant les différentes sessions de surveillance à partir des mêmes points sur la zone de surface de peau humaine ; et à déterminer et sauvegarder dans l'unité de mémoire un résultat fondé sur la comparaison, la même image de la zone de surface de peau humaine et les mêmes indications des points pour les mesures de température étant affichées sur l'écran pendant chaque session de surveillance de la période de surveillance lorsque les mesures de température sont obtenues. L'invention concerne également un dispositif pour la surveillance de maladies, le dispositif comprenant un ensemble de composants, à savoir : une unité de mémoire (2), un écran (3), un appareil de prise de vues (5), un capteur infrarouge (4), un outil (9) pour l'unification des mesures de température, des boutons de commande (7), une alimentation électrique (8), un module de communication (6), un processeur (1) connecté à l'unité de mémoire, à l'écran, au capteur infrarouge, à l'appareil de prise de vues, au module de communication, aux boutons de commande, à l'alimentation électrique, et un boîtier. De préférence, le dispositif pour la surveillance de maladies comprend un ensemble de composants attribués dans un boîtier, à savoir : une unité de mémoire, un écran, un appareil de prise de vues, un capteur infrarouge, un outil pour l'unification des mesures de température, des boutons de commande, une alimentation électrique, un module de communication, un processeur connecté à l'unité de mémoire, à l'écran, au capteur infrarouge, à l'appareil de prise de vues, au module de communication, aux boutons de commande, et à l'alimentation électrique. De préférence, le capteur infrarouge, l'outil pour l'unification des mesures de température, l'alimentation électrique pour le module distant, le module de communication pour le module distant, les boutons de commande pour le module distant et le processeur pour le module distant se présentent sous forme de module distant dans un boîtier séparé et fonctionnellement couplé à un ensemble de composants attribués présents dans un autre boîtier séparé qui comprennent au moins un module de communication, un processeur, une alimentation électrique, des boutons de commande, une unité de mémoire, un écran, et un appareil de prise de vues, également appelé dispositif de réception, de traitement, de sauvegarde et d'affichage d'informations. Ledit dispositif est, par exemple, un ordinateur personnel avec une webcam, une tablette, un téléphone intelligent, un téléphone mobile avec un appareil photo, ou un enregistreur vidéo numérique. Le groupe d'inventions permet d'augmenter la précision de surveillance d'une maladie dans l'intervention d'un spécialiste, de simplifier, et de rendre moins onéreux l'obtention d'informations portant sur l'évolution d'un état pathologique et de conclusions portant sur l'efficacité d'un traitement sans l'intervention d'un spécialiste.
PCT/RU2013/000967 2012-10-30 2013-10-29 Méthode et dispositif pour la surveillance de maladies WO2014070045A1 (fr)

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RU2012146179 2012-10-30
RU2012146179/14A RU2545423C2 (ru) 2012-10-30 2012-10-30 Способ мониторинга заболеваний
RU2013112804 2013-03-22
RU2013112804/14A RU2013112804A (ru) 2013-03-22 2013-03-22 Способ мониторинга заболеваний и устройство для его осуществления

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CN104000561A (zh) * 2014-06-07 2014-08-27 林聪� 多功能体温测量仪
CN104093003A (zh) * 2014-07-24 2014-10-08 成都市晶林科技有限公司 一种建筑物检测系统及方法
CN104083154A (zh) * 2014-07-24 2014-10-08 成都市晶林科技有限公司 一种人群健康检测系统及方法
CN106308848A (zh) * 2015-07-10 2017-01-11 通用电气公司 一种用于测量超声影像的方法及装置
CN113984247A (zh) * 2021-11-03 2022-01-28 中国人民解放军空军军医大学 一种多点式人体测温装置

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Cited By (6)

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Publication number Priority date Publication date Assignee Title
CN104000561A (zh) * 2014-06-07 2014-08-27 林聪� 多功能体温测量仪
CN104093003A (zh) * 2014-07-24 2014-10-08 成都市晶林科技有限公司 一种建筑物检测系统及方法
CN104083154A (zh) * 2014-07-24 2014-10-08 成都市晶林科技有限公司 一种人群健康检测系统及方法
CN106308848A (zh) * 2015-07-10 2017-01-11 通用电气公司 一种用于测量超声影像的方法及装置
CN106308848B (zh) * 2015-07-10 2024-01-23 通用电气公司 一种用于测量超声影像的方法及装置
CN113984247A (zh) * 2021-11-03 2022-01-28 中国人民解放军空军军医大学 一种多点式人体测温装置

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