RU210078U1 - DEVICE FOR SCREENING PATHOLOGIES OF EXTERNAL AND INTERNAL GENITAL ORGANS IN WOMEN - Google Patents

Abstract

The utility model is aimed at creating a multifunctional diagnostic device that allows screening of female genital organs with simultaneous visual and cytological examination in one session, including independently, in real time, which is the technical result. It contains a sealed body in the form of an elongated body of rotation from mating elements, having a head and tail parts, two wide-angle video cameras and an illuminator installed in the head part, communication means for data transmission to a personal device and batteries installed in the tail part. A pH meter, a pulse oximeter, an infrared thermometer connected to signal processing and diagnostic means, the outputs of which are connected to communication means, as well as means for carrying out an acetic sample and taking material for cytological examination, located in the head part of the body, are introduced. The second video camera is installed together with the first video camera with the possibility of a circular view of the diagnostic field, and the illuminator is made on RGB LEDs with the possibility of performing fluorescent diagnostics in the ultraviolet range of the spectrum. 7 w.p. f-ly, 3 ill.

Description

The utility model relates to medical equipment and telemedicine, in particular to mobile devices for diagnosing and preventing diseases of the female genital organs.

It is known that precancerous changes are reliably detected when examining the external genitalia and vestibule, vaginal walls, cervix, determining the pH of the environment, measuring vaginal basal temperature, determining tissue oxygen saturation - measuring capillary blood flow, assessing the vascular pattern, taking cytological material, holding acetic samples. Diagnostic tools for such studies are in demand by medical specialists (see World Health Organization (WHO) [Internet resource]: Cervical Cancer Elimination Initiative. - Internet data. 2020. URL: https://www.who.int/initiatives/cervical -cancer-elimination-initiative).

Various devices for screening the pathology of the female genital organs are described, including those using optical and electrical means of non-invasive diagnostics. Thus, the known device "ZedScan" from the company Zilico [Muszynski, C et al. Journal of gynecology obstetrics and human reproduction vol. 46.9 (2017): 669-673. doi:10.1016/j.jogoh.2017.08.0071], which is based on the technology of electrical impedance spectroscopy, complements the existing diagnostic method based on a cytological examination of a smear from the cervical canal and the surface of the cervix.

Emre et al. "Efficacy of a real time optoelectronic device (TruScreen™) in detecting cervical intraepithelial pathologies: a prospective observational study." Journal of the Turkish German Gynecological Association, vol. 16,1 41-4. 1 Mar. 2015, doi:10.5152/jtgga.2015.15199, которое основано на регистрации оптической плотности здоровых и патологических клеток. Использование устройства происходит в режиме реального времени, однако может быть использовано лишь при посещении медицинского учреждения, кроме того требует проведения комплекса дополнительных исследований.Described is a portable optoelectronic device for diagnosing dysplasia and cervical cancer "TruScreen" from the company TruScreen [

Emre et al. "Efficacy of a real time optoelectronic device (TruScreen™) in detecting cervical intraepithelial pathologies: a prospective observational study." Journal of the Turkish German Gynecological Association, vol. 16:1 41-4. 1 Mar. 2015, doi:10.5152/jtgga.2015.15199, which is based on the registration of the optical density of healthy and pathological cells. The device is used in real time, however, it can only be used when visiting a medical institution, in addition, it requires a set of additional studies.

Described is a portable device (CN 102188228 (A), ZHONGLIANG ZHU, 09/21/2011) for cervical cancer detection. The detection head includes an illuminator and a miniature electron microscope camera located at the front end of the probe for jointly collecting cervical image data and transmitting the data to an image display device. Images are transmitted over the Internet for remote diagnostics. The device has a number of significant drawbacks, the main of which is the need for a diagnostic procedure in a medical prophylactic institution.

A portable device is described for electrical measurements in different frequency ranges and optical measurements at three wavelengths, as well as for sampling in case of pathology (US 9289172 (B2), ITESM, 03/22/2016). Based on the described design, the device is unable to take into account the anatomical bend, which can give a false negative result of the Pap smear analysis, since the sampling can occur from the walls or fornix of the vagina. In addition, the device evaluates the tissue according to such criteria as: healthy tissue, tumor tissue and tissue with human papillomavirus. These characteristics exclude intermediate conditions such as mild to severe squamous intraepithelial disease. The definition of these conditions can significantly change the tactics of managing a patient during their verification. Also, the device does not have a built-in camera for photo and video recording of the self-diagnostic procedure, which does not allow using this device for telemedicine.

Another device (CN 110448264 (A), SHANGHAI FALUYUAN MEDICAL INSTR CO LTD, 11/15/2019, and CN 210277123 (U) - 04/10/2020) describes an electronic vaginal examination system. The system consists of a detector, a control and display module, a print module and a base. The base consists of a power supply module, an external USB power supply and a printer data interface module, as well as a detector charging module. The control and display module contains a tablet computer or a mobile phone and performs the functions of controlling the detector using wireless communication technology, obtaining images and displaying images. The invention further discloses a framework applied to an electronic vaginal examination system. According to the electronic vaginal examination system, the detector and wireless network are used to realize the detection function, so that the doctor can obtain images of the cervix and print out the diagnosis report through the examination system at the time of the first diagnosis. However, the system is devoid of additional diagnostic methods, such as measuring the pH of the vagina, taking cytological material and measuring basal temperature, which does not allow for a complete remote assessment of the condition of the lower part of the genital tract in a woman. A woman still needs to carry out diagnostic procedures at a full-time appointment in a gynecological chair.

The closest analogue to the patented device is a compact mobile device for examining the entire surface of the vagina, including the fornix and outer surface of the cervix without the use of additional tools (RU 173784 U1, Romanova, 09/11/2017 - prototype). It contains a small-sized video camera with a wide-angle lens and a fixed focal length, a radio transmitter for transmitting images to a computer, an electric compressor for expanding the walls of the vagina by creating excess air pressure, batteries, and a lamp. The probe body is an elongated figure of rotation, consisting of conjugated cylinders of various diameters. The thick part of the probe body has a diameter of 35 mm to 40 mm, the handle and the seat for the nozzle have a diameter of 20 mm to 30 mm. The nozzle is a truncated cone or cylinder with an outer diameter corresponding to the diameter of the thick part of the probe body and with an inner hole that exceeds the diameter of the seat on the insert by 0.1 mm. The nozzles have flanges protruding towards the central axes. In addition, the probe may additionally contain sensors for determining the temperature in the vagina and for measuring the strength of the muscles of the vagina. This prototype has a significant drawback, the need to carry out the procedure with the help of an assistant (nurse or doctor), which completely excludes the option of having a self-diagnosis function.

The analysis shows that the devices described above, including the prototype, have limited functionality, tk. do not combine the functions of other well-known diagnostic tests for this disease, do not allow monitoring the patient's health while she is at home, and also within the framework of telemedicine do not allow consulting health workers when providing medical care at a distance.

This utility model is aimed at creating a multifunctional diagnostic device that allows screening of the lower part of the genital tract and external female genital organs with simultaneous visual and cytological examination, in one go, including independently, in real time, which is the technical result. .

The patented device for screening female genital organs contains a sealed body in the form of an elongated body of rotation made of conjugated elements, having a rounded head and tail parts, the first wide-angle video camera and an illuminator installed in the head part, communication means for transmitting data to a personal device and installed in the tail parts of the batteries.

The differences are as follows.

In addition, a second wide-angle video camera, a pH meter, a pulse oximeter, an infrared thermometer connected to signal processing and diagnostic means, the outputs of which are connected to communication means, as well as means for conducting an acetic sample and taking material for cytological examination, are placed in the head part of the housing. The second video camera is installed together with the first video camera with the possibility of a circular view of the diagnostic field, and the illuminator is made on RGB LEDs with the possibility of performing fluorescent diagnostics in the ultraviolet range of the spectrum.

The device can be characterized by the fact that the mating elements of the housing are made movable relative to each other with the possibility of repeating the anatomical shape of the vagina, and also by the fact that the housing has two compartments located between the head and tail parts, the first of which contains signal processing devices on the side of the head part and diagnostics, and the second - a microprocessor, control modules and means of communication with Wi-Fi antennas for transmitting data to a personal device.

The device may also be characterized by the fact that the control modules include means for wireless charging of batteries using the Qi protocol.

The device can also be characterized by the fact that the means for conducting an acetic test include a cassette receiver for a cartridge with a 5% solution of acetic acid, while the spray gun for spraying the specified solution onto the surface of the cervix is installed in the hole at the head end of the housing, and also by the fact that the means for sampling cytological material includes a retractable mechanism with a latch installed in the hole at the head end of the body, the drive of which is installed in the second compartment of the body.

The device can also be characterized by the fact that the personal device is a smartphone, a portable tablet or a personal computer, and in addition, by the fact that the diameter of the head and tail parts of the body is 40-50 mm and 30-40 mm, respectively, and the length is 170- 190 mm.

The essence of the utility model is illustrated in the drawings, where:

fig. 1 - functional diagram of the device;

fig. 2 is a block diagram of a diagnostic device;

fig. 3 - placement of elements on the head of the device.

The patented device allows carrying out gynecological telemedicine diagnostic measures (visual examination, external genitalia, vestibule and walls of the vagina, cervix, measurement of pH and basal temperature, assessment of vascular pattern and capillary blood flow, sampling of cytological material and conducting an acetic test), aimed at eliminating cancer cervix.

The device for screening female genital organs (Fig. 1) contains a sealed housing 1 in the form of an elongated body of rotation from conjugated elements forming a rounded head 2 and tail 3 parts, between which two compartments 4, 5 are placed. Head 2, tail 3 and compartments 4, 5 are made movable relative to each other with the possibility of repeating the anatomical shape of the vagina, for which they are interconnected by bearing assemblies 6. In the tail 3 part there is a power module 7, in compartment 4 - a control and communication module 8, in compartment 5 - module 9 signal processing and diagnostics. The head part 2 has a transparent fairing, measuring and diagnostic sensors 10 are placed in the cavity of the head part 2. The body 1 has a completely sealed coating and protection from moisture. The covering is made of elastic "Soft-touch" material.

The dimensions of the hull are: the diameter of the head and tail parts of the hull is 40-50 mm and 30-40 mm, respectively, and the length is 170-190 mm. The smaller diameter of the caudal part of the body avoids pain due to stretching of the walls of the vaginal vestibule during the diagnostic procedure.

In FIG. 2 is a block diagram of an apparatus which includes: a Qi power receiver 11; battery 12; power controller 13; system board 14; central processing unit 15; Wi-Fi communication module 16 for transmitting data to a personal device; a temperature recording module 17 including an IR thermometer 171; module 18 registration of acidity, including a pH meter 181; module 19 for controlling and powering video cameras 191, 192 intended for photo and video recording.

The device also includes: a cytobrush control module 20, including a cartridge 201 with an electric drive 202 for extending the cytobrush; pulse oximeter module 21 with IR sensor 211; an acid sample module 22 with an acetic acid cartridge 221 and a spray pump 222; lighting module 23 with four RGB LEDs 231. The modules are connected by buses that provide the transmission of information signals and control from the modules to the central processor during the study.

The IR thermometer 171 for measuring basal temperature and the IR sensor 211 for pulse oximetry allow you to more accurately assess the phase of the menstrual cycle, capillary blood flow and oxygen saturation. The 181 pH meter sensor evaluates the value of the acid-base state of the vagina, and also allows you to assess the state of the vaginal microflora.

In FIG. 3 schematically shows the placement of measuring and diagnostic sensors 10 on the head part 2 of the device. The through hole 203 in the fairing of the head part 2 of the housing 1 is formed to ensure the functioning of the module 20 of the cytobrush control. Another through hole 222 is provided to enable the atomizer of the acid sample module 22 to function.

Two wide-angle video cameras 191 and 192 with polarizing filters and a resolution of 1080 × 1920 pixels make it possible to avoid artifacts during photo and video recording and visualize 360 degrees of the diagnostic field.

The parameters of the four RGB LEDs 291 are selected from the conditions of operation in both the visible and ultraviolet ranges of the spectrum, which allows, in addition to field illumination for video cameras 191 and 192, also fluorescent diagnostics.

Methods and means for conducting acetic samples are known from the prior art. The acid sample module 22 includes a cassette holder for a cartridge 221 with a 5% acetic acid solution of 5 ml.

The cytobrush control module 20 for collecting cytological material is also known from the prior art and includes a retractable mechanism with a latch placed in the hole 203 at the head end 2 of the body 1, the motor of which is installed in the compartment 4 of the device.

Batteries - rechargeable battery 12 with the controller 13 allow you to use a fully charged device without being tied to the mains, mobile and remotely from the medical institution. The ability to connect the utility model to a personal device (smartphone, portable tablet or personal computer) via the Wi-Fi 16 module makes it possible to conduct primary gynecological examination and diagnostic procedures at considerable distances from the medical institution and undergo preventive gynecological examination at the appointed time and date. The device connects to a smartphone and is used as an external device for taking photos and videos. Video and photo images of the study are stored in the smartphone's memory. In the same place, the pH values, temperature and capillary blood flow of each examined area are recorded in accordance with the location of the device in the vagina.

Before using the device, it is necessary to use a gynecological swab to remove physiological secretions from the mucous membranes of the vagina and cervix.

The device is started after power is applied to the system board 14, the control controller 13, diagnostic devices and sensors of the head.

After switching on, the device is installed at the level of the pubic symphysis at a distance of 10 cm from the surface of the skin and mucous membrane of the external genital organs. With a slow downward movement, an examination of the entire surface of the external genital organs is carried out. Further, the thumb and forefinger of the hand produce an abduction movement of the labia majora. With a slow upward movement, an examination of the mucous surface of the external genital organs and the vestibule of the vagina is carried out.

At the next stage of the study, the surface of the body 1 of the device, with the exception of the head part 2, is lubricated with a lubricant to increase sliding along the mucous surface of the vagina. The device is slowly inserted into the vagina and brought to the start of visualization by video cameras 191 and 192 of the surface of the cervix. In the process of moving the device through the vagina, the basal temperature is measured with an IR thermometer 171 and the acidity of the vagina with the sensors of the pH meter 181.

Upon reaching the surface of the cervix, the movement of the device is stopped and the function of measuring capillary blood flow using the IR sensor 211 of the module 21 of the pulse oximeter is turned on. Further, by means of the cytobrush control module 20, it is advanced from the technical hole 203 and navigated to the surface of the cervix and cervical canal. Cytological material is taken in a clockwise circular motion 5 times. After collecting the cytological material, the cytobrush is returned to the cartridge 201.

Further, at the next stage, the module 22 of the acid test using the pump 222 sprays the solution of acetic acid through the technical hole 223 in the head part 2. Within 30 seconds, the reaction of the cervical epithelium to the solution of acetic acid is video recorded and the reaction is photographed.

After the manipulations, the device is removed from the vagina, a gynecological swab is inserted to remove the remnants of the acetic acid solution and lubricant. Used cartridges with acetic acid solution and cytobrush are removed from the device. The cartridge with the used cytobrush is opened and the cytobrush is placed in a sterile box to store the biomaterial and transport it to the laboratory for liquid cytology testing. The result of the study is sent to the gynecologist and the patient. Video and photo materials are sent for further interpretation to a gynecologist. If necessary, the procedure can be repeated many times.

Thus, the patented multifunctional device combines the functions of a colposcope, an IR thermometer, a pulse oximeter, a pH meter, a cytobrush, and an acetic test. Ease of use allows screening without visiting the doctor's office. Recorded video footage and diagnostic parameters can be sent to a doctor's personal computer or mobile phone for follow-up observation and data interpretation. The device allows you to monitor the health status of the patient while she is at home, as well as to advise health workers in the provision of medical care in the framework of telemedicine, which indicates the achievement of a technical result.

Claims (8)

1. A device for screening the lower part of the genital tract and external female genital organs with simultaneous visual examination and sampling for cytological examination at one time in real time, containing a sealed housing in the form of an elongated body of rotation from conjugated elements, having a rounded head and tail parts, the first wide-angle video camera and an illuminator installed in the head part, communication means for transmitting data to a personal device and batteries installed in the tail part, characterized in that a second wide-angle video camera, a pH meter, a pulse oximeter, an infrared thermometer connected with means of signal processing and diagnostics, the outputs of which are connected to the means of communication, as well as means for conducting an acetic sample and taking material for cytological examination, located in the head part of the housing, while the second video camera is installed together with the first video a camera with the possibility of a circular view of the diagnostic field, and the illuminator is made on RGB LEDs with the possibility of performing fluorescent diagnostics in the ultraviolet range of the spectrum. 2. The device according to claim. 1, characterized in that the mating elements of the housing are made movable relative to each other with the possibility of repeating the anatomical shape of the vagina. 3. The device according to claim. 1, characterized in that the body has two compartments located between the head and tail parts, the first of which contains signal processing and diagnostic devices from the head part, and the second - a microprocessor, control modules and means of communication with Wi -Fi antennas to transmit data to a personal device. 4. The device according to claim 3, characterized in that the control modules include means for wireless charging of batteries using the Qi protocol. 5. The device according to claim 1, characterized in that the means for conducting an acetic test include a cassette receiver for a cartridge with a 5% solution of acetic acid, while the spray gun for spraying the specified solution onto the surface of the cervix is installed in the hole at the head end of the housing. 6. The device according to claim 3, characterized in that the means for collecting cytological material includes a retractable mechanism with a latch installed in the hole at the head end of the housing, the drive of which is installed in the second compartment of the housing. 7. The device according to claim. 1, characterized in that the personal device is a smartphone, portable tablet or personal computer. 8. The device according to claim 1, characterized in that the diameter of the head and tail parts of the body is 40-50 mm and 30-40 mm, respectively, and the length is 170-190 mm.

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