PL239554B1 - Monitoring device for measuring temperature and EMF radiation in the form of an intimate monitor, its application and monitoring method with its use - Google Patents

Description

The subject of the invention is a MI monitoring device for measuring the temperature and electromagnetic radiation EMF in the form of an intimate monitor adapted to measure these parameters in the vicinity of the testes of a man equipped with a sensor, containing a temperature sensor and an EMF electromagnetic radiation sensor, and a main unit that collects data on temperature and radiation readings. EMF and communicates with the receiving device. The invention also relates to a method of monitoring male testicular temperature while monitoring EMF electromagnetic radiation using an MI device and its applications.

STATE OF THE ART

Many years of research conducted by the world health organization indicate that the reproductive capacity of people around the world deteriorates every year. It is estimated that over 90,000,000 couples worldwide suffer from infertility. There are many reasons for this, both on the part of men and women.

In addition to purely medical reasons - such as, for example, a history of diseases or congenital diseases, a very common parameter that has a huge impact on fertility or the lack of it is the lifestyle of men and women - adequate nutrition, body weight, sleep, alcohol and other stimulants. The use of electronic devices that emit electromagnetic radiation also has a great impact.

In over 40% of infertile couples, the situation is caused by a problem that lies with men. Their inadequate behavior, such as lack of exercise, overweight, inadequate nutrition, and overheating of the testicles lead to a reduction in the parameters of the sperm they produce. According to the information posted on the website exam-nasienia.pl, the study by: E. Filipiak, J. Słowikowska-Hilczer "any phenomena that raise the temperature of the scrotum, and thus the temperature of the testicles, adversely affect the quality of sperm by interfering with the production of sperm". "On the other hand, when it comes to environmental factors, this group includes, among others, frequent hot baths, frequent visits to the sauna, wearing windproof, tight underwear or pants, sedentary work / living, working or staying in conditions of increased temperature ”.

According to the publication "The lifestyle of a modern man and the problem of infertility" Nowiny Lekarskie 2008, 77, 5, 357-361) the proper course of the spermatogenesis process requires a temperature 3-4 ° C lower than the normal body temperature. Chronic temperature changes in the scrotum can significantly reduce the biological value of semen.

Exposure of the human body to electromagnetic radiation also has a huge impact on the reproductive organs and other parts of the human body in both men and women.

This applies not only to the early stage of planning offspring, but also to the period of pregnancy and the development of the newborn child. The publication "Radiations and male fertility" (KK Kesari et al., Reproductive Biology and Endocrinology, vol. 16, 118 (2018), shows the results of research related to the exposure of mammals to the electromagnetic field. Exposure to the effects of waves emitted by cell phones causes adverse changes in the amount of produced hormones, the volume and quality of sperm, and unfavorable changes in DNA chains.

Devices for measuring temperature are known in the art. The currently available devices mainly function as thermometers and can be used both for newborns, children and adults. The available devices are in the form of closed devices that display information on the device screen, as well as devices that communicate with applications on mobile devices.

There is a known disposable TempTraq® temperature meter in the form of a stick-on patch, which only contains a temperature sensor and a Bluetooth transmitter, which can only work up to 48 hours from start-up.

Known is the Cadi Sense wireless thermometer, which - the device consists of a main unit - mounted on the body of e.g. a child and a transmitter that transmits the measurement results from the main unit to a database on the Internet.

There are devices in a stick-on form, it communicates with receiving devices via Bluetooth, e.g. Tucky thermometers, which enable continuous temperature monitoring.

PL 239 554 B1

There are known devices that enable contactless temperature reading, e.g. from the forehead, which include non-contact thermometers for measuring body temperature with the use of infrared measurement.

Known electronic devices for measuring temperature are designed either standalone or integrated with applications. The materials used for their construction, their product features, shape and size are designed to read the values of temperature readings from specific places of the human body, and thus indicate their unambiguous use - the possibility of temperature readings from indicated specific places.

Known measuring devices do not contain additional sensors for electromagnetic radiation or a motion sensor, these devices cannot be placed on the nucleus and used for temperature and electromagnetic radiation readings from this part of the male body, in addition, these devices emit an electromagnetic field at the place of the measurement. These devices are characterized by a varying degree of technological advancement, some of them use analog temperature sensors that require calibration, and the measurements obtained by using them are not precise.

Commercially available temperature measuring devices cannot be used as measuring and monitoring devices for the temperature of the male testes. There are also no known monitoring devices adapted to measure temperature and electromagnetic radiation adapted to conduct these measurements for the male testes without being exposed to electromagnetic radiation.

DISCLOSURE OF THE INVENTION

In the light of the described state of the art, the aim of the present invention is to overcome the indicated disadvantages and to provide a new monitoring device in the form of an intimate monitor adapted to measure the temperature and the level of electromagnetic radiation of the male testes at the same time ensuring wearing comfort, intimacy, convenience as well as adequate sanitary conditions, non-allergenic and ensuring not only monitoring but also informing about exceeded temperature standards and / or electromagnetic radiation.

Taking into account the parameters influencing the quality of male sperm, i.e. the temperature of the male testes, electromagnetic radiation fields around the testicles, and physical activity, innovative measuring devices in the form of a monitoring device, also known as an intimate monitor, have been developed. The developed solution is able to monitor the values of these parameters in real time.

The values of the temperature parameters of the nuclei and electromagnetic radiation (EMF) that reaches the nuclei are read by appropriate sensors placed in the part forming the sensor, the collected data is collected in the main unit of the monitoring device, and then sent to the mobile application, which is a beneficial element of the entire system. The main unit can additionally contain sensors measuring the physical activity of a man, e.g. an accelerometer sensor and communicating a specific state, e.g. overheating, e.g. by vibration, in which case a vibrating motor will be additionally placed in the main unit. The main unit is also provided with an energy source, for example in the form of a rechargeable battery or a battery. Communication between the sensor forming the measuring unit with temperature and EMF radiation sensors and the main unit takes place through a thin communication cable, which limits the emission of electromagnetic radiation in the vicinity of the nuclei.

The presented device (the invention) transmits the measurement results by wire to the central unit, so it does not emit radiation directly at the place of the measurement.

The collected data is then sent from the master unit to the receiving device with the application, e.g. a mobile device, preferably via radio communication, preferably via radio waves emitted by a low power transmitter, e.g. via Bluetooth. Based on the designed functionality and internal mechanisms, this application provides the user with data on the values of temperature parameters, EMF radiation and his physical activity, allowing him to perform appropriate preventive measures to minimize the impact of adverse or exceeded parameters, and thus ensuring optimal conditions for proper spermatogenesis and ultimately increasing the sperm quality and thus the fertility of the male using the monitoring device according to the invention.

The invention relates to a monitoring device for measuring the temperature and electromagnetic radiation EMF in the form of an intimate monitor which contains

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- sensor, equipped with a contact part and sensor electronics, containing a temperature sensor and an EMF electromagnetic radiation sensor, the sensor having a round flat shape with a contact part placed on the flat side of the sensor and adapted to be placed in contact through the contact part with the scrotum of the man's testicles the sensor electronics is housed inside the sensor and is in contact with the skin via the contact portion;

- main unit equipped with a power source, receiver / transmitter system for receiving the reading and communicating with the sensor and a transmitter / receiver for wireless communication with a receiving device equipped with an application enabling the reception and analysis of data transmitted from the main unit to the receiving device, the main unit is provided with a power on / off switch in the electrical system of the main unit, and the main unit elements are housed in a housing, preferably oblong, flattened;

the main unit is connected via a thin communication cable to the sensor by which power is transmitted and communication between the main unit and the sensor takes place; the main unit collecting data related to the temperature and EMF radiation readings on the sensor; wherein at least the outer layers of the sensor and the communication cable are made of or covered with materials approved for skin contact in medical applications.

In a preferred monitoring device, the temperature sensor is a digital sensor providing measurement accuracy of at least tenths of ° C and a temperature reading of at least once per minute, preferably a real time reading.

In a preferred monitoring device, the EMF field sensor is adapted to read radiation in the range of 2.3-2.5 GHz, preferably read Bluetooth, Wifi, ZigBee in the monitored band range from 2400 MHz to 2483 MHz.

In a preferred MI monitoring device, communication between the head unit and the receiver device takes place via Bluetooth radio communication, preferably using BLE technology.

In a preferred monitoring device, the main unit is provided with an indicator diode connected to the electrical system of the main unit, preferably the indicator diode is an RGB diode.

In a preferred monitoring device, when the power source in the main unit is a battery, the main unit comprises a socket for charging the power source, preferably the socket for charging is a USB link, preferably a micro USB link, preferably the socket for charging at the same time is a port for communication between the main unit and the main unit. receiving device with the application.

In a preferred monitoring device, at least one additional sensor measuring a specific parameter or activity of the subject is arranged in the main unit.

In a preferred monitoring device, the additional measurement sensor is an accelerometer.

In a preferred monitoring device in the main unit there is at least one additional element communicating a specific state, preferably the specified state is too high temperature of the testes, registration of excessive radiation in the vicinity of the testes, too long time without physical activity of the subject.

In a preferred monitoring device, the defined state communicating element is a vibrating motor.

In a preferred monitoring device, the receiving device is a smartphone, computer, laptop, tablet, smartwatch, medical device and / or service platform programmed with an application that receives readings from the host device, more preferably a smartphone.

In a preferred monitoring device, the contact part is made of or covered with a layer of silver, silvered brass, titanium, surgical steel.

In a preferred monitoring device, the sensor on the contact side and the contact part are covered with an adhesive layer approved for skin contact in medical applications, enabling the sensor to be firmly secured in contact with the skin of the scrotum.

In a preferred monitoring device, the receiving device is additionally provided with a data repository which makes it possible to record and store the obtained data for later reading.

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The monitoring device is preferably further provided with a temperature sensor comprising a digital temperature sensor ensuring measurement accuracy of at least tenths of ° C and a temperature reading of at least once a minute, preferably with a real-time reading adapted to interact directly in a wired or wireless manner with the main unit of the MI monitoring device or with the receiving device with the application.

The invention also relates to the use of a monitoring device according to the invention for monitoring the temperature of the testes of men with simultaneous monitoring of the EMF electromagnetic radiation in the area of the testes of men, preferably in addition to the simultaneous monitoring of the body temperature of the man.

The invention also relates to the use of a monitoring device according to the invention for improving the quality of sperm in men.

The invention also relates to the use of a monitoring device according to the invention for the prevention and / or treatment of male infertility.

The invention also relates to a method of monitoring male testicular temperature while monitoring electromagnetic EMF radiation in the testicular region using a monitoring device according to the invention, the method comprising the following steps: a) contacting the scrotum with skin of the sensor so as to make the contact portion of the sensor in contact with the skin; (b) read the temperature and EMF radiation intensity measurements by the sensor by means of the sensor electronics placed thereon, and transmit the readings to the receiver to the main unit; c) transmitting the readout values of temperature and EMF radiation intensity from the receiver system of the main unit with built-in wireless communication device to the receiving device. In a preferred method, the body temperature of the male is additionally measured simultaneously with steps b) and c) by means of a temperature sensor.

The term electromagnetic field or EMF (electromagnetic field) as used here should be understood as the electromagnetic field emitted by various sources - such as e.g. mobile phones, laptops, tablets, Wi-Fi routers and the like.

The term BLE (Bluetooth Low Energy) as used herein is one of the subsets of the Bluetooth wireless communication standard between devices, e.g., a telephone and a device with sensors. BLE technology is very energy-efficient and considered to be less harmful to human health, because transmitters using BLE technology emit low-power radio waves and they rarely do it.

The data repository should be understood as the place of storage and storage of user profile data, measurement values from sensors and other data processed as part of an intimate monitor.

A mobile application should be understood as any software for connecting to and receiving a signal from a monitoring device and preferably also communicating back with the monitoring device, for example it will be an end-user interface that displays in a graphical form the measurement results from the device, enables the determination of the operating parameters of the monitoring device. which can be configured to inform the user of unfavorable measurement parameters in order to prevent these parameters from being exceeded and to make the semen quality adversely affected by these factors.

An RGB diode is an optoelectronic semiconductor, a diode capable of generating three basic colors (red, green, blue) thanks to the possibility of mixing them, allows to generate virtually any color.

The closure of temperature and EMF radiation sensors in a very small volume in the part of the MI monitoring device created by a sensor made of an appropriate material reducing the likelihood of allergies while ensuring adequate comfort of use and limiting the emission of electromagnetic waves in the vicinity of the testicles by using a cable connection between the measuring unit and the central unit. the monitors according to the invention are completely innovative compared to those currently available on the market.

Preferably, the temperature sensor used is a digital sensor, which is characterized by high measurement precision, preferably reaching tenths of a degree, preferably also by a fast response to changing temperature values (sensor capabilities for monitoring the temperature range -40 - + 125 ° C). The preferably used EMF electromagnetic field sensor is characterized by high measurement precision, preferably also a quick response to changing field strength values and the ability to read a wide spectrum of radiation, in particular EMF

PL 239 554 B1 (range of the monitored band preferably from 2400 MHz to 2483 MHz) - Bluetooth (range of the monitored band preferably from 2400 MHz to 2483 MHz), Wifi (range of the monitored band preferably from 2400 MHz to 2483 MHz), ZigBee (range of the monitored band preferably from 2400 MHz to 2483 MHz). Preferably the sensor is adapted to measure a range corresponding to the radio wave ranges used in cell phones or other mobile devices frequently carried in trouser pockets, preferably measures bands in the range 2-3 GHz, more preferably 2.4-2.480 GHz.

The values read by the sensor (temperature, EMF) are transmitted to the main unit via a transmission cable. Moving the main unit, which performs the communication function with the connected smartphone application away from the sensor, moves the transmission medium away from the male reproductive organs, thus ensuring that they are not exposed to electromagnetic radiation related to wireless transmission.

The contact part of the sensor is made of a material that conducts temperature well, which ensures correct temperature readings, as the contact part contacts the skin of the nucleus with the temperature sensor located in the sensor. The contact part of the sensor can be made of metal or alloy approved for medical use and devoid of allergenic properties or with reduced allergenic properties - for example silver, silver-plated brass, titanium, surgical steel.

At least the outer parts of the monitoring device, i.e. the parts of the device in contact with the skin or epidermis of the subject, are made of plastics approved for contact with the skin in medical applications, preferably non-allergenic, or made of a metal or medical alloy, preferably non-allergenic. allergenic or with reduced allergenic properties (e.g. ABS-M30i) Materials in contact with the skin of the subject should therefore comply with EN ISO 10993 Biological evaluation of medical devices, EN ISO 10993-18: 2009 Biological evaluation of medical devices - Part 18: Chemical characterization materials.

The temperature values read by the sensor placed in the sensor allow to obtain information about the current temperature of the testicles, information about the increased temperature of the testicles, which is one of the parameters disturbing proper spermatogenesis. The unfavorable conditions for proper spermatogenesis in the form of increased testicular temperature disturb its process, which affects the quality of sperm produced and contributes to male infertility. Monitoring the temperature of the testicles by transferring this information to an integrated application on the receiving device with the application, e.g. a smartphone in combination with appropriate algorithms triggering notifications, allows for appropriate response to emerging overheating situations in order to eliminate and minimize the effects of such situations, which may improve the quality of sperm and the reproductive capacity of the male using the monitoring device of the invention.

The MI monitoring device in question also has an EMF electromagnetic field sensor that allows readings of the intensity of electromagnetic radiation around the male genitalia. The information obtained from the EMF sensor in conjunction with the built-in algorithms allows the person wearing the sensor to be informed on an ongoing basis about the occurrence of sources emitting an increased electromagnetic field and increased radiation values. This information will allow us to react to the emerging radiation sources often coming from various places, such as e.g. mobile phones, laptops, tablets, Wi-Fi routers, by avoiding these sources and implementing remedial measures related to the presence of such sources, and being in the vicinity of such sources. A particularly common problem that affects sperm quality is wearing cell phones in the front pockets of trousers or working with a laptop held in the testicles area. The monitoring device according to the invention, by alerting the owner to an increased intensity of electromagnetic EMF radiation in the vicinity of the testes, will make it possible to prevent unnecessary exposure to EMF radiation.

The temperature sensor with which the monitoring device may be additionally equipped may be any sensor containing a digital temperature sensor ensuring measurement accuracy of at least tenths of a ° C and a temperature reading of at least once a minute, preferably with a real-time reading adapted to interact directly wired or wireless with the main unit of the monitoring device or with the receiving device with the application.

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The conducted studies on the impact of EMF radiation on mammalian cells indicate the negative effects of constant exposure of cells to EMF radiation. The publication entitled "Radiations and male fertility", Kavindra et al., Reproductive Biology and Endocrinology volume 16, 118 (2018), shows the results of studies on the influence of the EMF field on DNA fragmentation and thus on the reduction of the viability and quality of the produced sperm.

The system of temperature and EM radiation sensors located in the sensor, in one of the preferred embodiments of the monitoring device according to the invention, is supplemented with a physical activity measuring system located in the main unit, which, for example, allows you to measure the number of steps and the distance that a man has walked, thus assessing his physical activity. . In a further advantageous embodiment of the monitoring device according to the invention, a signaling element, for example in the form of a vibration motor, is mounted in the main unit. The signaling element has alarming functions and informs the user about the events of exceeding the temperature value - e.g. overheating of the testicles or exposure to increased EMF electromagnetic radiation of his reproductive organs.

The data read in the sensor are transferred to the receiver - the main unit, which sends them to the receiving device with an integrated application, preferably mobile, that allows you to set readout parameters, e.g. frequency, and display data collected by sensors located in the sensor, i.e. temperature, radiation and in the main unit that is, the movement of the subject.

The main unit is separated from the point of monitoring the nuclei in terms of their temperature and EMF radiation radiation in order to move the transmission sources away from the place of detection.

When the main unit has a built-in RGB diode, it serves as a signaling function for the user and determines the operating status of the device - connection, charging / discharging / charging the battery.

In a preferred embodiment of the device, the device communicates with the user by means of four mechanisms: the BLE protocol, the signaling diode, the vibration motor and the power switch.

An application on the receiving device, preferably the user's smartphone, also takes part in communication of the individual parts of the monitoring device. It displays the values of measurement parameters coming from the sensor, and allows you to control the operation of the monitoring device parameters.

A preferred receiving device with an application sending communication is a smartphone, but other mobile devices may also be used for this purpose - e.g. laptops, tablets, smart watches (smartwatches), computers or other platforms of medical devices and services.

The data flow in the monitoring device according to the invention takes place from the sensor from its contact part in contact with the user's skin, the value of the temperature parameter is read, and the EMF radiation value from the second sensor is possible thanks to appropriately selected sensors integrated in the sensor.

The read values are transferred by wire to the main unit, where the data can be collected and supplemented with the read values of the user's position of the x, y, axis from the accelerometer. These values can be sent to the receiving device. In one of the preferred implementations of the device, the read values can be stored in the cache of the monitoring device, which collects the readout value data from the sensors, and then sends it to a mobile application that is part of the solution - a mobile application operating for specific systems, e.g. for android systems or IOS for smartphones, or they can be stored on external systems.

The mobile application illustrates the read parameters, e.g. by displaying the parameters of the parameters of the read data from sensors located in the sensor, and in a preferred embodiment also from sensors located in the main unit. Then, using an internal presentation layer, it displays them to the user and also activates, if so set up the application, the corresponding alarms, activating the signaling element, for example turns on the vibrating motor in the main unit.

The data displayed in the application can be shared with selected people (partner, doctor) or groups of people. The data collected in the application is saved in the data repository.

The flow of communication and data also takes place in the direction from the mobile application to the sensor. It is possible to set configuration parameters - e.g. time periods for readings by sensors. The values set in the application regarding the operation of the sensor and the main unit are saved to the configuration settings of the device or devices.

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The user interface is a mobile application available in versions that allow interaction of the monitoring device with the receiving device, for example an application for Android (Google) and IOS (Apple) systems. The interface allows you to read data from sensors located in the sensor and the main unit of the device and hardware elements of the device - Bluetooth connection status with the sensor, battery charge status in the main unit.

The data that is read is preferably presented graphically to the user of the application.

The user interface allows you to set the operating parameters of the monitoring device, i.e. the frequency of reading measurements of temperature, EMF radiation, physical activity, e.g. the number of steps taken.

The user interface will present data in the appropriate metric units for your country - kilograms, pounds, inches, degrees Celsius or Fahrenheit and others.

The values of the read measurements are stored in the device's memory and then sent to the mobile application, which aggregates the values of the measurements obtained from temperature sensors, electromagnetic radiation and from the accelerometer. These measurements are sent to the receiving device, for example to a smartphone's mobile application, and stored in the data repository.

The receiving device with the application may be any device capable of communicating with the receiving main unit, the receiving device with the application will be, for example, a computer, a mobile device, e.g. a laptop, tablet, smart watches (smartwatches), other devices or other platforms of medical devices and services, most preferably smartphone.

It should be understood that the present disclosure is not limited to the specific aspects or embodiments described as these may, of course, be different. It should also be understood that the terminology used herein is for the purpose of describing specific aspects or embodiments only and is not intended to be limiting as the scope of the present disclosure will be limited only by the appended claims.

SHORT DESCRIPTION OF THE DRAWING FIGURES

For a better understanding of the invention, it is illustrated in the exemplary embodiments and in the accompanying drawing figures, in which:

Fig. 1 shows a general layout diagram of the monitoring device;

Fig. 2 shows in detail the construction of the sensor of the monitoring device A - top view, the contact part of the sensor with the transmission cable is shown; B - side view - cross-section of the sensor with the transmission cable shown;

Fig. 3 shows a schematic front view of the main unit (measurement receiver) of the monitoring device;

Fig. 4 shows a schematic rear view of the main unit (measurement receiver) of the measuring device;

Fig. 5 shows a graph of the change in testicular temperature over time A - measurement scheme made with the monitoring device according to the invention, B - the same record with an indication of the relationship between temperature and user activity;

Fig. 6 shows a graph of the value of electromagnetic radiation reaching the nuclei measured with a monitoring device according to the invention;

Fig. 7 shows schematically an exemplary method of mounting the device on a patient. A - standard version - mounting of the sensor to the scrotum, B - version with an example of mounting two sensors;

Fig. 8 shows an exemplary flowchart of information flow in the monitoring device between the sensor and the head unit and between the head unit and the receiving device.

The monitoring device depicted in the attached figures is only shown as illustrative, while the final shape of the solution, its elements, sensor placement, materials used, components used and coexisting solutions such as a smartphone, an application may be changed without departing from the purpose and idea implemented by the device monitors according to the invention.

Publications cited in the specification and references therein are also herein incorporated by reference.

METHODS OF CARRYING OUT THE INVENTION

The following examples illustrate the invention without limiting it in any way.

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EXAMPLES

Example 1. Monitoring device

The MI monitoring device according to the invention, also known as the intimate MI monitor for men, was built of the following elements giving it a unique functionality and adaptation to ensure the possibility of properly measuring the temperature of the testicles and the intensity of EMF radiation in the vicinity of the testicles and transmitting this information to the receiving device 13 equipped with an application enabling the reception and analysis of this data. A schematic diagram of the entire monitoring device is shown in Fig. 1, and details of the various parts in Figs. 2-4.

The MI monitoring device includes sensor 1, which is equipped with a contact plate 2 and the electronic system of sensor 3, containing a Silicon Labs SI7051 temperature sensor with a measurement accuracy of ± 0.1 ° C and a radiation sensor (Texas Instruments LMH2110 8-GHz Logarithmic RMS Power Detector with 45-dB Dynamic Range). The sensor 1 is connected to the main unit 5 through a thin communication cable 4, both parts are covered with medical silicone. The temperature sensor used is a digital sensor, which is characterized by a very high precision of measurements, reaching tenths of a degree, and a quick response to changing temperature values. The used EMF electromagnetic field sensor is characterized by a very high precision of measurements, quick response and the ability to read a wide spectrum of EMF radiation - Bluetooth, Wifi, ZigBee. The applied radiation sensor can read a wide spectrum of radiation, and in this embodiment the antenna has been set to capture the range from 2400 MHz to 2483 MHz.

The plastic and metal skin contact materials used were approved for skin contact in medical devices and in accordance with EN ISO 10993 Biological evaluation of medical devices, EN ISO 10993-18: 2009, Biological evaluation of medical devices Part 18: Chemical characterization of materials.

The main unit 5 is also provided with a power source (energy) which, in the embodiment shown, was a battery. If the power source is a battery, the main unit 5 has a charging socket 9 for the power source, which in this embodiment was a micro USB connection. The micro USB link can also be a port for communication between the main unit and the receiving device with the application, e.g. with a computer. The power source can also be a battery or some other type of power supply. The main unit is provided with a receiver circuit 6 for receiving a reading from the sensor 1 and a transmitter for communicating with the receiving device 13.

The main unit 5 communicates with the receiving device 13 provided with an application enabling the reading of the data collected by the sensor 3. In the monitoring device MI made, communication between the main unit 5 and the receiving device 13 was carried out by radio communication using Bluetooth. In the device made, the transmitter was a Bluetooth device that communicated via low-power radio waves with a receiving device 13, which was a smartphone programmed with an application receiving readings from the main device 5.

After fixing the sensor 1 on the nuclei in a way ensuring contact of the contact plate of the sensor 2 with the skin of the testicle by means of a medical patch, powered by the energy source from the main unit 5, the sensor 1 measures the temperature and intensity of the EMF radiation with the help of electronic circuits of sensors 3 placed thereon. The readout of these values is transmitted on an ongoing basis to the receiver 6 located in the main unit 5. Via Bluetooth communication, the receiver system 6 of the main unit 5 with a built-in Bluetooth device transmits the read values of temperature and EMF radiation intensity on an ongoing basis to the receiving device 13 in the form of a smartphone, which it analyzes and processes the received data and displays it on the smartphone's display. The receiving device 13 was additionally provided with a data repository, which made it possible to record and store the time obtained data for later reading.

The electronic circuit of the sensor 3 is placed inside the sensor 1 and contacts the skin by means of a contact plate 2. The shape of the sensor 1 and the contact plates 2 it consists of are flat and oval, which makes it comfortable for the user to wear, as well as ensuring a large enough space for the user. correct readings on the contact surface with the nucleus. The shape of the sensor 3 is profiled and safe, it does not contain protruding sharp elements that could potentially expose the wearer to injuries. The whole thing is made of a material that meets the relevant medical standards, does not cause allergies, which makes the MI monitoring device safe for the patient. All the parts used are made of materials that meet the Restriction of Hazardous Substances (ROHS) standard, which specifies the restrictions on the use of certain hazardous substances.

In electrical and electronic equipment - lead, mercury, cadmium, hexavalent chromium, polybrominated biphenyls (PBB) and polybrominated phenyl ethers (PBDE). In addition, skin contact materials complied with EN ISO 10993 Biological evaluation of medical devices, EN ISO 10993-18: 2009 Biological evaluation of medical devices - Part 18: Chemical characterization of materials.

The various components of the main unit 5 are housed in a housing 15, preferably made of antiallergic materials that are allowed to come into contact with the human skin (e.g. ABS-M30i).

The casing has a round shape and there is an on / off switch 8 of the power supply 16, which switches the power supply on / off in the electrical system of the main unit 5. The casing 15 has a built-in signaling diode 10, which in the presented embodiment was an RGB diode connected with the main unit's electrical system 5 , which performs signaling functions for the user - determines the operating status of the device - connection, battery charging, etc. depending on the selected settings.

The data flow is bidirectional as shown in Fig. 8. The data is transferred from the sensors to the main unit, data from the main unit and other sensors in it are transferred to the receiving device, information about the readout parameters is also transferred from the application to the main unit which controls the reading. parameter values from sensors in the sensor.

Example 2. Monitoring device with additional functions

The MI monitoring device was made similar to Example 1, in addition, the main unit 5 has a system for measuring the physical activity of a person wearing a MI monitoring device in the form of a 3-axis accelerometer, which includes an acceleration sensor and a vibration motor. Accelerometer, allows you to measure angular or linear acceleration. The values of these accelerations are then converted using appropriate algorithms into the number of steps, the distance that the man has walked, thus estimating his physical activity. Additionally, a signaling element 12, which was a vibrating motor, was mounted in the main unit 5. It has an alarming function and informing the user about the events of exceeding the temperature value - e.g. overheating of the testicles or exposure to electromagnetic radiation EMF. The vibrating motor vibrates after receiving a signal about exceeding a certain value of a given parameter (temperature, EMF radiation intensity from the receiving device from the application, transmitted as a feedback signal to the main unit. Housing 15 of the main unit was additionally equipped with a cavity constituting a place for docking the sensor 11.

P r z k ł a d 3. Variant of the monitoring device

The MI monitoring device was made similar to Example 1, except that the contact part of the sensor 2 comprises a metal fixed plate made of a non-allergenic material covered with a silver layer, and additionally on the outside of the contact part of the sensor 2 an adhesive layer (e.g. Bio2Skin) was applied. http://besthealth4u.pt/portfolio/bio2skin/). This allows for a better thermal conductivity of the sensor 1, an easier way to attach the sensor 1 with an adhesive layer on the contact part 2 on the sensor 1 and is also allergy neutral by the use of metal and a medical grade adhesive.

P r z k ł a d 4. Variant of the monitoring device

The MI monitoring device was made similar to Example 1, except that the sensor includes an infrared sensor, the contact portion does not include a metal plate and is coated with an adhesive layer (e.g. Bio2Skin).

Example 5. Temperature and EMF radiation measurements on nuclei with the MI monitoring device

Temperature and EMF radiation measurement readings on the nuclei were carried out under various conditions by means of the MI monitoring device according to the invention.

The MI monitoring device manufactured according to Example 2 was attached to the skin of the scrotum as shown in Fig. 7A. Preferably, it was attached to the left or right testicle in the center. Fastening was carried out with the use of adhesive glue applied to the sensor 1 from the side of the contact plate 2 or a medical plaster with appropriate medical approvals by means of which the sensor 1 was glued to the skin of the scrotum.

Using the application located on the receiving device 13, the parameters of the continuous reading of temperature, EMF radiation and the movement of the subject subjected to measurements were set.

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The main unit 5 connected by the communication cable 4 to the sensor 1 transmitted the collected measurements to the receiving device 13 - the user's smartphone. The main unit 5 includes a dedicated fastening clip 7 that allows the main unit 5 to be conveniently clipped into the user's underwear or other garment.

Testicular temperature readings were carried out in the daily cycle of a man's life, during various activities - daily activities, sleep, driving a car, walking, standing, etc.

The collected values show the time periods and during which activities the temperature of the testicles increases, it helps the user to understand during which activities the testes overheat and excessive EMF irradiation, and what activities or behaviors should be avoided in order not to lead to such situations. The results of measurements obtained by the monitoring device were presented in a visual form available to the user, and they could also be transmitted in the form of alerts, e.g. when certain values were exceeded, signaled by a vibrating engine, without the need to display temperature measurement parameters or radiation readings in the application.

The monitoring device with the use of the EMF electromagnetic radiation sensor also made it possible to read the value of this radiation, the field of which covers the male nucleus. This allowed for the registration of such cases in order to know the values that were emitted and to introduce countermeasures eliminating or limiting the intensity of this type of radiation in the area of the male nuclei.

Fig. 5A is a graph showing the values of the measured testicle temperature in a man as a function of his activity, and Fig. 5B is the same graph with an indication of a specific physical activity performed at a given point in time. Initially, when inserting the sensor, the temperature values are around 32.5 ° C - 9.15 a.m., then you can see the relative stabilization - until 9:46 a.m. After 9:46 a.m. to 10:02 a.m., the temperature rises to about 35 ° C - during this time the subject was driving a car. From 10:02 am to 10:08 am - there is a decrease of the measured temperature value to the value of about 33.5 ° C - during this time the subject performed activities while standing. In subsequent readings from 10:02 to 10:21, when he travels by car, a clear increase in temperature can be seen. In the next stages, you can see the temperature drops associated with the change in activity.

Fig. 6 is a graph showing aggregate measurements of electromagnetic radiation values emitted by a mobile phone carried in a man's pocket. Periodic increases in the radiation value are visible, they last for about 1 minute of time, and then there is a decrease in these values, and then the EMF radiation values increase again. There is a noticeable correlation between the increase in EMF radiation and the proximity of the smartphone to the nuclei (EMF sensor). This is a pictorial graph showing the radiation values read for a man's cell phone (smartphone) carried in his pants pocket. The sensor built into the monitoring device also allows reading these values from other electronic devices emitting such radiation, such as laptops, WiFi cards, tablets, WiFi networks, other devices within the range of which the person wearing the sensor will be.

P r z k ł a d 6. Measurement of temperature in the testes, in the armpit and EMF radiation in the testes using a monitoring device containing two sensors

MI monitoring device prepared according to Example 2 except that the device was additionally equipped with a second body temperature sensor 1a. Measurements of temperature and EMF radiation on the testes with the MI monitoring device according to the invention were carried out as shown in Fig. 7B, in addition, the temperature was read in parallel from the second sensor 1a attached under the armpit. The sensor 1a measuring the body temperature by measuring under the armpit was the same as sensor 1, also connected to the main unit 5 by means of a communication cable 4 with the possibility of detaching / connecting to the main unit 5. Both sensors were attached using adhesive glue applied to sensor 1 and 1a from the side of the contact plate 2 or medical patch, by means of which sensor 1a was glued to the skin in the armpit and sensor 1 to the skin of the scrotum.

The parameters for the continuous reading of the temperature were set by means of the application on the receiving device 13.

The main unit 5 connected by a communication cable to two sensors 1, 1a transmitted the collected measurements to the receiving device 13 - the user's smartphone. The main unit 5 comprises

There is a dedicated fastening clip 7 that allows the main unit 5 to be conveniently fastened to the user's underwear or other garment.

The temperature sensor 1 a may be any sensor comprising a digital temperature sensor providing a measurement accuracy of at least tenths of ° C and a temperature reading of at least once a minute, preferably with a real-time reading adapted to interact directly in a wired or wireless manner with the unit. main monitoring device or with the receiving device with the application.

The readings of the temperature of the testes and EMF electromagnetic radiation in the vicinity of the testes and the male body were carried out in a daily cycle, during various activities - daily activities, sleep, driving, walking, standing, etc., as in Example 5. Additional data collected from the second body temperature sensor 1a allow you to monitor body temperature, send appropriately constructed alarms, correlate the collected measurements with testicular temperature and analyze both measurements, study their relationships and generate appropriate signals for the user based on them, allowing for even more accurate and precise avoidance of situations threatening the deterioration of sperm quality through overheating and irradiation and take appropriate countermeasures.

LIST OF MARKINGS

MI - Monitoring Device (Intimate Monitor for Men)

- sensor a - body temperature sensor

- contact part of the sensor (contact plate)

- sensor electronics (including a temperature and EMF radiation sensor)

- communication cable

- main unit

- receiver pcb layout

- fastener

- device on / off switch

- connecting socket, e.g. micro usb

- signaling diode

- sensor docking point

- signaling element (e.g. vibrating motor)

- receiving device with the application

- physical activity measuring system

- main unit housing

Patent claims

Claims (21)

Patent claims A monitoring device for measuring the temperature and electromagnetic radiation EMF in the form of an intimate monitor, characterized in that it comprises - sensor (1), equipped with a contact part (2) and an electronic system of the sensor (3), including a temperature sensor and an EMF electromagnetic radiation sensor, the sensor (1) having a flat oval shape with the contact part (2) placed on the flat side sensor and is adapted to be placed in contact through the contact part (2) with the scrotum of the man's testicle, the electronic circuit of the sensor (3), which is placed inside the sensor (1) and is in contact with the skin by the contact part (2); - a main unit (5) provided with a power source, a receiver / transmitter system (6) for receiving a reading and communicating with the sensor (1) and a transmitter / receiver for wireless communication with a receiving device (13) equipped with an application enabling the reception and analysis of transmitted data from the main unit (5) to the receiving device (13), the main unit is provided with a power on / off switch (8) in the electrical system of the main unit (5), and the main unit (5) elements are located in a housing (15), preferably oblong and flattened in shape; the main unit (5) is connected via a thin communication cable (4) with the sensor (1), through which power is transmitted and communication between the main unit (5) and the sensor (1) takes place, Wherein the main unit (5) collects data on the temperature readings and EMF radiation on the sensor (1); wherein at least the outer layers of the sensor (1) and the communication cable are made of or covered with materials approved for skin contact in medical applications. 2. A monitoring device according to claim 1 The method of claim 1, characterized in that the temperature sensor is a digital sensor ensuring measurement accuracy of at least tenths of ° C and temperature reading at least once per minute, preferably real-time reading. 3. A monitoring device according to claim 1 1-2, characterized in that the EMF field sensor is adapted to read radiation in the range 2.3-2.5 GHz, preferably read Bluetooth, Wifi, ZigBee in the monitored band range from 2400 MHz to 2483 MHz. 4. A monitoring device according to claim 1, 1-3, characterized in that in the monitoring device MI, communication between the main unit (5) and the receiving device (13) was via radio communication using Bluetooth, preferably using BLE technology. 5. A monitoring device according to claim 1 1-4, characterized in that the main unit (5) is provided with a signaling diode (10) connected to the electrical system of the main unit (5), preferably the signaling diode (10) is an RGB diode. 6. A monitoring device according to claim 1 1-5, characterized in that when the power source in the main unit (5) is a battery, the main unit (5) comprises a charging socket (9) of the power source, preferably the charging socket (9) is a USB link, preferably a micro USB link. preferably, the charging socket (9) simultaneously constitutes a port for communication of the master unit (5) with the receiving device (13) with the application. 7. A monitoring device according to claim 1, The method according to any of the claims 1-6, characterized in that in the main unit (5) at least one additional measuring sensor measuring a specific parameter or activity of the subject is located. 8. A monitoring device according to claim 1, 7. The method of claim 7, characterized in that the additional measurement sensor is an accelerometer. 9. A monitoring device according to claim 1, 1-8, characterized in that at least one additional element communicating a specific state is placed in the main unit (5), preferably the specified state is too high temperature of the testes, registration of excessive radiation in the vicinity of the testes, too long time without physical activity of the subject. 10. A monitoring device according to claim 1 9. The device of claim 9, characterized in that the means communicating the predetermined state is a vibration motor. 11. A monitoring device according to claim 1, 1-10, characterized in that the receiving device (13) is a smartphone, computer, laptop, tablet, smartwatch, device and / or medical services platform programmed with an application receiving readings from the host device (5), more preferably a smartphone. 12. A monitoring device according to claim 1, A method according to any of the claims 1-10, characterized in that the contact part (2) is made of or covered with a layer of silver, silvered brass, titanium, surgical steel. 13. A monitoring device according to claim 1, 1-10, characterized in that the sensor (1) on the contact side part and the contact part (2) are covered with an adhesive layer approved for contact with the skin in medical applications, enabling a stable fixation of the sensor (1) in contact with the skin of the scrotum. 14. A monitoring device as claimed in claim 1, The method according to any one of the claims 1-13, characterized in that the receiving device (13) is additionally provided with a data repository which enables the obtained data to be recorded and stored for later reading. 15. A monitoring device according to claim 1, 1-14 characterized in that it further comprises a body temperature sensor (1a) comprising a digital temperature sensor ensuring measurement accuracy of at least tenths of ° C and a temperature reading at least once per minute, preferably with a real-time reading adapted to to interact directly in a wired or wireless manner with the main unit (5) of the MI monitoring device or with the receiving device with the application (13). PL 239 554 B1 16. Use of a device as defined in claim 1, 1-15, for monitoring the temperature of the testes of men with simultaneous monitoring of EMF radiation in the area of the testicles in men. 17. The use according to claim 1 16. The method of claim 16, wherein the male body temperature is additionally monitored simultaneously. 18. Use of a device as defined in claim 1 1-15 to improve semen quality in men. 19. Use of a device as defined in claim 1 1-15 for the prevention and / or treatment of male infertility. 20. A method of monitoring male testicular temperature while simultaneously monitoring the electromagnetic EMF radiation in the testicular region by a monitoring device as defined in claim 1. 1-15, which method includes the following steps a) the sensor (1) is attached in contact with the skin of the scrotum in such a way as to ensure that the contact part (2) of the sensor (1) is in contact with the skin; b) reading the temperature and EMF radiation intensity measurements by the sensor (1) by means of the sensor electronics (3) placed thereon and transmitting the readings to the receiver (6) to the main unit (5); c) transmitting from the receiver circuit (6) of the main unit (5) with the built-in wireless communication device the read values of temperature and EMF radiation intensity to the receiving device (13). 21. The method according to p. 20, in which, additionally, in parallel with step b and c, the male body temperature is simultaneously measured by means of the temperature sensor (1a).