System and method for gynecological examination

Abstract

This invention relates to a system and method for self-administering gynecological examinations. The system includes a device for performing a medical self-examination, the device having an elongated body having a proximal end and a distal end; the distal end being configured for insertion into a subject's body cavity; one or more forward imaging devices disposed at the distal end of the elongated body and configured to acquire one or more images and / or videos of the internal environment of the subject's body cavity; one or more external imaging devices disposed on a base and facing the elongated body and configured to acquire one or more images and / or videos of the external environment of the subject's body cavity; and a processor including instructions for guiding the subject to complete the self-examination process.

Description

[0001] Cross-reference to related applications

[0002] This application claims priority to U.S. Provisional Patent Application No. 63 / 596,988, filed November 8, 2023, the contents of which are incorporated herein by reference in their entirety. Technical Field

[0003] The present invention relates, in some embodiments thereto to systems and methods for gynecological examinations, and more specifically, but not limited to, systems and methods for performing gynecological examinations independently. Background Technology

[0004] Additional background art includes U.S. Patent US10,694,954, which discloses a system for imaging and diagnosing internal tissues of a target, the system comprising an image acquisition system mechanically fixed to a speculum.

[0005] US Patent Application Publication No. US2019 / 0150725 discloses a speculum-free imaging system for colposcopes and breast examination devices.

[0006] U.S. Patent Application Publication No. US2021 / 0338214 discloses an endoscopic device for examining and collecting samples from a user's body cavities. Specifically, the device can be used for vaginal and cervical examinations. The device includes a camera attached to a probe, a radial illumination system attached within the probe, and a cellular brush for sample collection. A latex balloon and airflow directly through the port are also provided to dilate the vaginal cavity. The document also provides a method for sample collection and monitoring using a controlled camera.

[0007] U.S. Patent Application Publication No. US2021 / 0137357 discloses a digital device for assisting in the diagnosis of body cavities. This device enables the diagnosis of body cavities with or without a speculum. The device includes a housing for accommodating a probe and an additional channel. The additional channel includes multiple instruments. The probe is configured for optical and digital diagnosis of abnormalities within the body cavity. The probe is connected to a wireless communication component to display acquired images. The probe includes: an image acquisition device for acquiring images of the abnormal site in a time-series manner; an image processing device connected to a computing device for performing digital image diagnosis; and a bending control cable for providing bending control to the image acquisition device. The housing has a transparent cap configured to visualize the structure of the body cavity. The housing includes an inflatable outer pouch for separating / opening the walls of body parts.

[0008] Chinese patent application CN103948367 discloses a medical device and a vaginal speculum. The vaginal speculum includes a handle, a control unit disposed within the handle, and a column connected to the handle; the column is made of silicone; a balloon is disposed at the front end of the column; the balloon is made of ABS resin; the outer surface of the balloon is covered with a layer made of natural rubber; a camera and a light source are disposed at the front end of the column. The vaginal speculum is equipped with a light source, making it more convenient to use. The light source uses an LED lamp made of epoxy resin, which is highly safe, thus ensuring medical safety; the balloon and the covering layer will not scratch the hair and folds of the vagina, and will not cause discomfort to the woman being examined; the camera can perform omnidirectional imaging and image acquisition of the internal vaginal area, and transmit the captured images to a computer so that doctors and nurses can repeatedly review the images.

[0009] U.S. Patent Application Publication No. US2021 / 0094167 discloses a medical examination apparatus comprising a sampling tube detachably connectable to an observation tool having a fiber optic observation device. The sampling tube defines a first end and an opposing second end, and includes a tube wall extending between the first and second ends. The tube wall includes an inner surface and an outer surface extending between the first and second ends. The inner surface defines a central sampling channel, sized and configured to receive the sampling tool longitudinally. A longitudinal channel extends partially through the tube wall from the first end toward the second end. A light-transmitting lens is disposed adjacent to the second end of the tube for optical communication with the longitudinal channel. The fiber optic observation device is detachably inserted into the longitudinal channel to allow optical communication with the light-transmitting lens.

[0010] U.S. Patent Application Publication No. US2021 / 0033246 discloses an endoscope insertion aid comprising a tubular member, tubing, and a plurality of balloons. The tubular member allows insertion of an endoscope portion through it and guides longitudinal movement of the insertion portion. The tubing is disposed within the tubular member and communicates with a supply / exhaust unit to supply fluid to or exhaust fluid from the distal end of the tubular member. The plurality of balloons are disposed longitudinally along the outer periphery of the distal end of the tubular member and communicate with the tubing, thereby inflating or deflating according to the supply and exhaust of fluid via the tubing. When the balloons inflate, the outer diameter of the balloon located distal to the tubular member is larger than the outer diameter of the balloon located proximal to the distal balloon.

[0011] International patent application WO2022005043A1 discloses a disposable surface-emitting tongue depressor, or a disposable examination tongue depressor and examination device capable of self-collection of samples. This disposable surface-emitting tongue depressor includes a converging lens component that receives light from an LED light source and concentrates the light onto the tonsils and pharyngeal region, thereby reducing the number of medical devices required during the examination and alleviating the psychological stress on the patient. Furthermore, the tongue depressor is a single-use structure and can be discarded after use, thus avoiding the risk of cross-infection caused by reusing medical devices. The tongue depressor also includes a sampling plate that can be inserted into the nasopharynx to collect body fluid samples, allowing for convenient body fluid collection via the oral cavity, reducing the inconvenience and psychological stress on patients during traditional oral examinations and body fluid collection, while improving the efficiency of examination and sample collection.

[0012] US Patent Application US2021 / 0085413 discloses an anatomical positioning device for acquiring mechanical data from tissue to determine tissue type and transitional regions between different tissues and body cavities. The anatomical positioning device includes a cannula with a tip and an expandable device having a contracted state dimension and an expanded state dimension, wherein the expanded state dimension is significantly larger than the contracted state dimension. The anatomical positioning device also includes: a guide having a longitudinal axis and a distal end for facilitating the introduction of the expandable device in its contracted state into the tissue; an expansion mechanism for expanding and contracting the expandable device; and sensors for measuring physical parameters associated with the expandable device. Furthermore, a method for acquiring mechanical data from tissue is also disclosed, wherein the expandable device acquires the mechanical data while applying pressure to multiple portions of the tissue.

[0013] Chinese patent CN205083444 discloses a palpation probe, including a probe body, a probe handle, and a pressure sensor matrix disposed within the probe body. The probe body can be inserted into a human body cavity to sense the hardness, size, shape, and appearance of lesions on the inner wall of the body cavity and surrounding tissues, and transmits the relevant information to an external display device via a cable. The palpation probe also includes an LED light source and a camera, which allows for in-situ observation of the human body cavity, thereby observing the location and appearance of internal lesions. This device not only improves the accuracy and effectiveness of diagnosing lesions in body cavities and surrounding tissues, such as prostate cancer and rectal cancer, but also solves the technical problem of not being able to achieve in-situ observation during rectal cancer palpation.

[0014] U.S. Patent Application US2021 / 0220594 discloses an insertion guide core comprising a shaft having a flexible end section with a tip and a camera at the tip for providing an image of a portion of the environment surrounding the tip. The guide core includes a control unit for controlling the bending movement of the end section. The control unit is adapted to operate in at least two operating modes. In a first operating mode, the bending movement of the end section is automatically guided by the orientation of the tip. In a second operating mode, the bending movement of the end section is manually controlled by the user without automatic guidance. The control unit is also adapted to operate in the second operating mode when the first operating mode is not enabled. Summary of the Invention

[0015] The following is a non-exhaustive enumeration, including some examples of embodiments of the present invention. The present invention also includes embodiments that include fewer than all features in one example, and embodiments that use features from multiple examples, even if these embodiments are not explicitly set forth below.

[0016] Example 1. A method for performing a medical examination via a self-testing device, comprising:

[0017] a. Obtain one or more images and / or videos of one or more external anatomical landmarks and / or one or more internal anatomical landmarks;

[0018] b. Analyze one or more images and / or videos acquired;

[0019] c. Generate preliminary diagnostic results based on the analysis.

[0020] Example 2. The method according to Example 1, wherein the analysis includes:

[0021] a. Based on the analysis, identify one or more attributes associated with the one or more external anatomical landmarks and / or the one or more internal anatomical landmarks;

[0022] b. Compare the identified attributes with the predefined attributes;

[0023] c. Identify the differences between the compared attributes based on predetermined attribute thresholds;

[0024] Based on the identified differences between the attributes compared in the analysis, preliminary diagnostic results are generated.

[0025] Example 3. The method according to Example 1 or Example 2 further includes performing a calibration process; the calibration process includes:

[0026] a. Automatically identify one or more of the external anatomical landmarks; and

[0027] b. Automatically identify one or more of the internal anatomical landmarks.

[0028] Example 4. A method for performing a medical examination via a self-testing device, comprising:

[0029] a. Position the self-testing device in front of the target organ;

[0030] b. Acquire one or more images and / or videos of the external region of the target organ;

[0031] c. Insert a portion of the self-testing device into the human cavity opening of the target organ;

[0032] d. Acquire one or more images and / or videos of the internal region of the target organ;

[0033] e. Analyze one or more images and / or videos acquired;

[0034] f. Generate preliminary diagnostic results based on the analysis.

[0035] Example 5. The method according to Example 4 further includes identifying one or more external anatomical landmarks in the external region and identifying one or more internal anatomical landmarks in the internal region.

[0036] Example 6. The method according to Example 4 or Example 5, wherein the analysis includes:

[0037] a. Based on the analysis, identify one or more attributes associated with the one or more external anatomical landmarks and / or the one or more internal anatomical landmarks;

[0038] b. Compare the identified attributes with the predefined attributes;

[0039] c. Identify the differences between the compared attributes based on a predetermined attribute threshold;

[0040] Based on the identified differences between the compared attributes in the analysis, preliminary diagnostic results are generated.

[0041] Example 7. The method according to any one of Examples 4-6 further includes performing a calibration process; said calibration process includes:

[0042] a. Automatically identify one or more of the external anatomical landmarks; and

[0043] b. Automatically identify one or more of the internal anatomical landmarks.

[0044] Example 8. A method for automated quantitative pelvic organ prolapse (POP-Q) examination using a self-testing device, comprising:

[0045] a. Establish the locations of reference anatomical landmarks;

[0046] b. Insert a portion of the self-testing device into the body cavity opening;

[0047] c. Generate a data acquisition timeline while performing the insertion;

[0048] d. Acquire multiple data sets simultaneously with the insertion;

[0049] e. Correlate the acquired data with the data acquisition timeline;

[0050] f. Analyze the acquired data to identify anatomical landmarks;

[0051] g. Calculate the distance between a predetermined position on the self-testing device and the identified anatomical landmark;

[0052] h. Based on the calculation results, calculate the distance between the reference anatomical landmark and the identified anatomical landmark;

[0053] i. Compare the calculated distance between the reference anatomical landmark and the identified anatomical landmark with a distance value in the reference database;

[0054] j. Based on the comparison, assess whether the calculated distance is lower or higher than a predetermined threshold;

[0055] k. Generate diagnostic results based on the assessment.

[0056] Example 9. The method according to Example 8, wherein the acquired plurality of data sets includes one or more of the following:

[0057] a. Acquire multiple images and / or videos using the front-facing camera of the self-testing device;

[0058] b. Acquire multiple images and / or videos using the one or more external cameras of the self-test device; and

[0059] c. Acquire multiple sensor data from one or more sensors of the self-testing device.

[0060] Example 10. The method according to Example 8 or Example 9, wherein the reference anatomical landmark is the hymen.

[0061] Example 11. The method according to any one of Examples 8-10, wherein the acquisition includes acquiring one or more images and / or videos.

[0062] Example 12. The method according to any one of Examples 8-11, wherein the anatomical landmarks are one or more of the following: the midline of the anterior vaginal wall, the most distal portion of one side of the anterior vaginal wall, the lowest edge of the cervix, the highest point of the posterior vaginal wall, the midline of the posterior vaginal wall, the most distal portion of one side of the posterior vaginal wall, the urethral orifice, the midpoint of the posterior vaginal opening and the anal opening.

[0063] Example 13. The method according to any one of Examples 8-12, wherein the predetermined position on the self-test device is one or more of the following: the farthest end of the self-test device, the position of a camera located at the farthest end of the self-test device, and the position of one or more external cameras located on the self-test device.

[0064] Example 14. The method according to any one of Examples 8-13, wherein the insertion includes telescopically actuating said portion of the self-testing device while keeping the rest of the self-testing device stationary.

[0065] Example 15. A method for automatically assessing urinary incontinence in patients using a self-testing device, comprising:

[0066] a. Insert a portion of the self-testing device into the body cavity;

[0067] b. Visualize the cervix within the aforementioned human body cavity;

[0068] c. While maintaining visualization of the cervix, visualize the urethra;

[0069] d. Instruct the patient to perform exertion movements and / or physical exertion;

[0070] e. Acquire one or more medical data using the self-testing device while the patient is performing the exertion action and / or physical exertion;

[0071] f. Analyze the acquired medical data;

[0072] g. Based on the analysis, assess whether one or more of the following conditions have occurred:

[0073] i. Abnormal displacement of the cervix;

[0074] ii. The pressure sensor detected abnormal pressure;

[0075] III. Urine was detected flowing from the urethra.

[0076] Example 16. The method according to Example 15 further includes instructing the patient to assume a specific position.

[0077] Example 17. The method according to Example 15 or Example 16, wherein the physical exertion is coughing.

[0078] Example 18. The method according to any one of Examples 15-17, wherein the acquisition is performed via one or more of a front-facing camera, one or more external cameras, and one or more sensors disposed within the self-testing device.

[0079] Example 19. The method according to any one of Examples 15-18, wherein the medical data is one or more of images, videos, physiological measurement data and stress measurement data.

[0080] Example 20. A device for performing medical self-examination, the device comprising:

[0081] a. An elongated body having a proximal end and a distal end; the distal end being configured to be inserted into a body cavity of a subject;

[0082] b. A base connected to the proximal end of the elongated body;

[0083] c. One or more forward imaging devices disposed at the distal end of the elongated body; the one or more forward imaging devices being configured to acquire one or more images and / or videos of the internal environment of the body cavity of the subject; and

[0084] d. One or more external imaging devices disposed on the base and facing the elongated body; the one or more external imaging devices being configured to acquire one or more images and / or videos of the external environment of the subject's body cavity opening;

[0085] e. A processor disposed within the base; the processor includes instructions for guiding the subject to complete a self-test process.

[0086] Example 21. The apparatus according to Example 20 further includes a plurality of sensors.

[0087] Example 22. The apparatus according to Example 20 or Example 21, wherein the plurality of sensors are one or more of a vision sensor, an ultrasonic sensor, a temperature sensor, a pressure sensor, a humidity sensor, a pH sensor, a positioning sensor, a position sensor, and a force sensor.

[0088] Example 23. The apparatus according to any one of Examples 20-22, wherein the plurality of sensors are disposed on the outer surface of the elongated body; the plurality of sensors are configured to measure one or more sets of parameters of the internal environment of the human body cavity of the subject, the parameters / sets of parameters including at least one of impedance, pH value and pressure.

[0089] Example 24. The apparatus according to any one of Examples 20-23 further includes one or more integrated light sources adjacent to the one or more forward imaging devices and / or the one or more external imaging devices.

[0090] Example 25. The apparatus according to any one of Examples 20-24 further includes a graphical user interface (GUI) comprising one or more controls.

[0091] Example 26. The apparatus according to any one of Examples 20-25 further includes a first inflatable member connected to the elongated body; the first inflatable member is an annular member surrounding the annular body.

[0092] Example 27. An apparatus according to any one of Examples 20-26, wherein the apparatus includes controls configured to inflate and deflate the first inflatable member.

[0093] Example 28. The apparatus according to any one of Examples 20-27 further includes a second inflatable member, wherein the second inflatable member is connected to the first inflatable member and surrounds a portion of the first inflatable member at the distal end of the elongated body.

[0094] Example 29. The apparatus according to any one of Examples 20-28, wherein the elongated body is a telescopic elongated body configured to extend and retract.

[0095] Example 30. The apparatus according to any one of Examples 20-29, wherein the elongated body is flexible.

[0096] Example 31. The device according to any one of Examples 20-30, wherein the elongated body is configured to take the shape of the human body cavity and / or conform to the shape of the human body cavity.

[0097] Example 32. The apparatus according to any one of Examples 20-31 further includes one or more of the following:

[0098] a. At least one power source configured to provide power to the device;

[0099] b. At least one pump connected to a first inflatable member and a second inflatable member; and

[0100] c. A communication unit, which includes at least one of a wireless communication interface and a non-wireless communication interface.

[0101] Example 33. An apparatus according to any one of Examples 20-32, wherein the processor further includes instructions for performing the method according to any one of Examples 1, 4, 8 and / or 15.

[0102] Unless otherwise defined, all technical and / or scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention pertains. While similar or equivalent methods and materials may be used to implement or test embodiments of the invention, exemplary methods and / or materials are described below. In the event of conflict, this specification (including its definitions) shall prevail. Furthermore, the materials, methods, and embodiments described herein are for illustrative purposes only and are not intended to be limiting.

[0103] Those skilled in the art will understand that some embodiments of the present invention can be implemented as systems, methods, or computer program products. Therefore, some embodiments of the present invention can take the form of entirely hardware embodiments, entirely software embodiments (including firmware, resident software, microcode, etc.), or combined hardware and software embodiments, and these embodiments are generally referred to herein as “circuit,” “module,” or “system.” Furthermore, some embodiments of the present invention can take the form of computer program products stored on one or more computer-readable media on which computer-readable program code is stored. Implementation of the methods and / or systems of some embodiments of the present invention can involve manually, automatically, or in combination thereof, performing and / or completing selected tasks. Furthermore, in practical instruments and apparatus according to some embodiments of the methods and / or systems of the present invention, several selected tasks can be implemented by hardware, software, or firmware and / or combinations thereof, for example, using an operating system.

[0104] For example, according to some embodiments of the present invention, the hardware for performing a selected task can be implemented as a chip or circuit. As software, the selected task according to some embodiments of the present invention can be implemented as multiple software instructions executed by a computer under any suitable operating system. In an exemplary embodiment of the present invention, one or more tasks of some exemplary embodiments of the methods and / or systems described herein are performed by a data processor, for example, by a computing platform for executing multiple instructions. Optionally, the data processor includes volatile memory for storing instructions and / or data and / or non-volatile storage means for storing instructions and / or data, such as a magnetic hard disk and / or a removable storage medium. Optionally, a network connection is also provided. Optionally, a display device and / or a user input device, such as a keyboard or mouse, are also provided.

[0105] Some embodiments of the present invention may use any combination of one or more computer-readable media. A computer-readable medium may be a computer-readable signal medium or a computer-readable storage medium. A computer-readable storage medium may be, for example, but not limited to, electronic, magnetic, optical, electromagnetic, infrared, or semiconductor systems, apparatuses, or devices, or any suitable combination of the foregoing. More specific examples (not exhaustive) of computer-readable storage media will include: electrical connections having one or more wires, portable computer disks, hard disks, random access memory (RAM), read-only memory (ROM), erasable programmable read-only memory (EPROM or flash memory), optical fiber, portable optical disc read-only memory (CD-ROM), optical storage devices, magnetic storage devices, or any suitable combination of the foregoing. In this specification, a computer-readable storage medium may be any tangible medium capable of containing or storing a program for use by, or in conjunction with, an instruction execution system, apparatus, or device.

[0106] Computer-readable signal media may include propagated data signals in which computer-readable program code is embedded, for example, propagated in baseband form or as part of a carrier wave. Such propagated signals may take any of a variety of forms, including but not limited to electromagnetic, optical, or any suitable combination thereof. A computer-readable signal medium may be any computer-readable medium that is not a computer-readable storage medium and is capable of transmitting, propagating, or transmitting programs for use by, or in conjunction with, an instruction execution system, apparatus, or device.

[0107] Program code stored on a computer-readable medium and / or data used therein may be transmitted using any suitable medium, including but not limited to wireless media, wired media, fiber optic cables, radio frequency (RF) media, or any suitable combination of the foregoing.

[0108] Computer program code used to perform operations of some embodiments of the present invention may be written in any combination of one or more programming languages, including subject-oriented programming languages ​​(e.g., Java, Smalltalk, C++, etc.) and traditional procedural programming languages ​​(e.g., the "C" programming language or similar programming languages). The program code may be executed entirely on the user's computer, partially on the user's computer, as a standalone software package, partially on the user's computer and partially on a remote computer, or entirely on a remote computer or server. In the latter case, the remote computer may be connected to the user's computer via any type of network, including a local area network (LAN) or a wide area network (WAN), or connected to an external computer (e.g., via the Internet through an Internet Service Provider (ISP)).

[0109] Some embodiments of the present invention will now be described with reference to flowchart illustrations and / or block diagrams of methods, apparatus (systems), and computer program products according to embodiments of the present invention. It should be understood that each block in the flowchart illustrations and / or block diagrams, and combinations of blocks in the flowchart illustrations and / or block diagrams, can be implemented by computer program instructions. These computer program instructions can be provided to a processor of a general-purpose computer, a special-purpose computer, or other programmable data processing apparatus to form a machine such that these instructions, executed by said processor, can perform the functions and / or operations specified in one or more blocks of the flowchart illustrations and / or block diagrams.

[0110] These computer program instructions may also be stored in a computer-readable medium that can direct a computer, other programmable data processing apparatus or other device to operate in a particular manner, such that the instructions stored in the computer-readable medium form an article of writing containing instructions for implementing the functions and / or operations specified in one or more blocks of a flowchart and / or block diagram.

[0111] These computer program instructions may also be loaded onto a computer, other programmable data processing apparatus or other device to cause a series of operational steps to be performed on the computer, other programmable data processing apparatus or other device, thereby forming a computer-implemented process, such that the instructions executed on the computer or other programmable apparatus can perform the functions and / or operations specified in one or more blocks of a flowchart and / or block diagram.

[0112] Some of the methods described in this article are typically designed to be performed solely by computers, and it may be impractical or unfeasible for human experts to perform these methods entirely manually. Human experts who wish to perform similar tasks manually often employ entirely different approaches, such as leveraging expert knowledge and / or the pattern recognition capabilities of the human brain, which would be far more efficient than performing the steps of the methods described in this article step by step manually. Attached Figure Description

[0113] The following description, in conjunction with the accompanying drawings, illustrates some embodiments of the present invention by way of example only. Referring now to the drawings in detail, it should be emphasized that the specific details shown in the drawings are merely illustrative and intended to explain embodiments of the present invention. After reading this specification in conjunction with the accompanying drawings, those skilled in the art will be able to clearly understand how to implement embodiments of the present invention. In the drawings:

[0114] Figure 1 This is a schematic diagram of an exemplary gynecological self-examination system according to some embodiments of the present invention;

[0115] Figure 2 This is a schematic diagram illustrating an exemplary unit of an exemplary self-examination device for performing gynecological self-examination according to some embodiments of the present invention;

[0116] Figures 3a-3j This is a schematic diagram of an exemplary self-testing device and its features according to some embodiments of the present invention;

[0117] Figures 4a-4q This is a schematic diagram of an exemplary embodiment of an inflatable member according to some embodiments of the present invention;

[0118] Figure 5 This is a cross-sectional schematic diagram of an exemplary self-testing device according to some embodiments of the present invention;

[0119] Figures 6a-6c This is a schematic diagram of an exemplary apparatus and method for determining distance during an inspection process according to some embodiments of the present invention;

[0120] Figure 7a A schematic diagram showing the appearance of the vaginal area;

[0121] Figure 7b This is a schematic diagram of external anatomical landmarks as seen from an external camera on the upper part of a self-testing device according to some embodiments of the present invention;

[0122] Figure 7c This is a schematic diagram of external anatomical landmarks as observed from a lower external camera of a self-testing device according to some embodiments of the present invention;

[0123] Figures 8a-8dA flowchart illustrating an exemplary method for performing external calibration from a system perspective according to some embodiments of the present invention;

[0124] Figure 9 A flowchart illustrating an exemplary method for performing external calibration from a user's perspective according to some embodiments of the present invention;

[0125] Figures 10a-10b This is a schematic diagram of the elongated body of a self-testing device according to some embodiments of the present invention inserted into a human body cavity;

[0126] Figure 10c This is a schematic diagram illustrating the visualization of the internal environment of a human body cavity through a self-testing device according to some embodiments of the present invention;

[0127] Figure 11 A flowchart illustrating an exemplary method for performing external and / or internal self-checks according to some embodiments of the present invention;

[0128] Figure 12 A schematic diagram of each positioning point in the POP-Q system;

[0129] Figures 13a-13c This is a schematic diagram of the positioning points and exemplary measurement parameters of a POP-Q system according to some embodiments of the present invention;

[0130] Figure 14 This is a schematic diagram of an exemplary self-testing device 102 for performing measurements according to some embodiments of the present invention.

[0131] Figures 15a-15b A flowchart illustrating an exemplary method for performing POP-Q evaluation by a system according to some embodiments of the present invention;

[0132] Figure 16 This is a schematic diagram of an exemplary self-testing device for performing measurements according to some embodiments of the present invention;

[0133] Figures 17a-17b A flowchart illustrating an exemplary method for performing POP-Q evaluation by a system according to some embodiments of the present invention;

[0134] Figure 18 This is a schematic diagram of an exemplary location for a self-testing device for assessing urinary incontinence according to some embodiments of the present invention;

[0135] Figure 19 A flowchart illustrating an exemplary method for assessing urinary incontinence using the system according to some embodiments of the present invention;

[0136] Figures 20a-20n These are exemplary visual data provided to artificial intelligence (AI) according to some embodiments of the present invention. Detailed Implementation

[0137] The present invention relates, in some embodiments thereto to systems and methods for gynecological examinations, and more specifically, but not limited to, systems and methods for performing gynecological examinations on oneself.

[0138] Overview

[0139] One aspect of some embodiments of the present invention relates to self-administered gynecological medical examinations. In some embodiments, the examination is performed using a dedicated device configured to guide a non-professional user through one or more steps of the medical examination. In some embodiments, the medical examination includes acquiring one or more of at least one image, at least one video, at least one ultrasound image, at least one physiological measurement, and at least one anatomical measurement. In some embodiments, data from the medical examination is provided to a medical professional. In some embodiments, data from the medical examination is provided to a healthcare professional. In some embodiments, data from the medical examination is automatically analyzed to provide medical analysis results to a healthcare professional and / or the user. In some embodiments, the analyzed medical data is used to diagnose a patient. In some embodiments, the diagnosis is performed automatically. In some embodiments, medical data acquired during the examination is used to generate a personalized medical record for the patient. In some embodiments, medical data acquired during the examination is used to update the patient's existing personalized medical record. In some embodiments, medical data acquired during the examination is compared to a personalized baseline and / or to data from a database. In some embodiments, the dedicated device includes an internal camera with a distance adjustment mechanism that allows automatic and / or manual repositioning of the internal camera to provide one or more of the following: improved focus; improved image quality, for example, in the presence of dirt and moisture on the probe tip cover; and an adjusted field of view to observe more or less of the sidewall area. In some embodiments, the dedicated device includes one or more inflatable bodies configured to expand the wall surface of the area to be inspected. In some embodiments, the inflatable bodies are configured to perform uniform / equidistant expansion and / or non-uniform / non-equidistant expansion. In some embodiments, the dedicated device includes one or more sensors configured to assist the inspection process.

[0140] Before detailing at least one embodiment of the present invention, it should be understood that the invention is not necessarily limited in its application to the structural details, component arrangements, and / or methods described in the following description, drawings, and / or examples. The invention may also have other embodiments or be implemented or practiced in various ways.

[0141] Now for reference Figure 1This illustration shows a schematic diagram of an exemplary gynecological self-examination system according to some embodiments of the present invention. In some embodiments, an exemplary gynecological self-examination system 100 includes a dedicated device 102 (hereinafter referred to as "self-examination device 102") for performing a gynecological examination by oneself, configured for use, for example, by a user without medical professional training, and further configured to collect one or more medical data (further description of self-examination device 102 is given below). In some embodiments, the dedicated device 102 is connected to one or more servers 104 (hereinafter referred to as "servers"). In some embodiments, the medical data collected by the self-examination device 102 is sent to the server 104. In some embodiments, the server 104 includes instructions for analyzing the medical data received by the self-examination device 102. In some embodiments, the server includes one or more databases configured to store various types of data, for example, for various purposes such as data comparison, verification, authentication, and in-depth analysis. In some embodiments, the medical data is sent to a medical professional 106, such as a doctor, nurse, or any other specialist or institution (e.g., an insurance company) with permission to receive the medical data. In some embodiments, the self-examination device 102 includes minimal software and hardware for analyzing the medical data (see below). In some embodiments, medical data is sent to a medical professional 106 in real time, i.e., while the user is collecting medical data using the self-testing device 102. In some embodiments, the medical professional 106 may access the data at a later time, for example, by accessing medical data stored in a server 104, or by directly accessing data stored in the self-testing device 102. In some embodiments, the system is configured to store and / or provide raw and / or analyzed medical data. In some embodiments, as will be further described below, the self-testing device 102 includes a portion (elongated body) inserted into the body cavity of the subject, while another portion of the device is used to collect data from the external region of the body cavity of the subject.

[0142] Exemplary self-test device 102

[0143] Now for reference Figure 2This illustration shows a schematic diagram of an exemplary unit of an exemplary self-testing device 102 for self-administering gynecological examinations according to some embodiments of the present invention. In some embodiments, the exemplary self-testing device 102 includes a housing 202 configured to encapsulate one or more electronic components. In some embodiments, the self-testing device 102 includes one or more sensors 204. In some embodiments, the one or more sensors are multiple different types of sensors. In some embodiments, the one or more sensors are multiple sensors of the same type. In some embodiments, the one or more sensors are multiple types of sensors, wherein each type has multiple sensors. In some embodiments, the self-testing device 102 includes one or more controllers 206 (… Figure 2 One is shown in the diagram, and is referred to below as the "controller". In some embodiments, the controller 206 includes instructions for performing one or more of the following (not an exhaustive list): activating one or more sensors 204, providing instructions to a user, receiving sensing data from the one or more sensors 204, and receiving / transmitting data. In some embodiments, the self-test device 102 includes one or more storage modules 208. In some embodiments, the self-test device 102 includes one or more communication units 210 configured to communicate, for example, with a server 104, with a medical professional 106, and / or with external electronic devices (e.g., mobile phones and / or tablets). In some embodiments, the self-test device 102 includes one or more graphical user interface units 212 (GIUs) configured to enable input / output interaction between the self-test device 102 and a user. In some embodiments, the GUI 212 is an integrated part of the self-test device 102. In some embodiments, the GUI 212 is separate from the self-test device 102, and communication between the device and the user is transmitted via wired and / or wireless means. In some embodiments, the self-test device 102 includes one or more power sources 214 configured to provide necessary power to various components of the self-test device 102. In some embodiments, the power source is provided by a battery, optionally a rechargeable battery. In some embodiments, power is provided via a cable connected to the self-test device 102. In some embodiments, the self-test device 102 includes one or more pumps 214 configured to inflate one or more balloons (see below).

[0144] Now for reference Figure 3a This illustration shows a schematic diagram of an exemplary self-testing device 102 according to some embodiments of the present invention. In some embodiments, the exemplary self-testing device 102 includes a handle 302 located at the proximal end of the self-testing device 102. In some embodiments, the exemplary self-testing device 102 includes a body 304 configured to accommodate a plurality of components, such as... Figure 2As shown. In some embodiments, the handle 302 is connected to the body 304. In some embodiments, optionally, the handle 302 is configured to receive at least a portion of electrical components. In some embodiments, the handle 302 and the body 304 are an integral structure. In some embodiments, the exemplary self-testing device 102 includes an elongated body 306 extending distally from the body 304 and configured to be inserted into a body cavity of a subject. In some embodiments, the elongated body 306 is configured to receive at least a portion of electronic components (see below). In some embodiments, the elongated body 306 is flexible, for example, as shown below. Figure 3b The diagram schematically illustrates, and / or may include, internal compartments that allow the elongated body 306 to bend to a certain degree. In some embodiments, the elongated body 306 is flexible enough to take on the shape of its insertion portion and / or conform to the shape of that portion. In some embodiments, the elongated body 306 is rigid, and the insertion portion of the elongated body 306 is adapted to the shape of the elongated body 306. Optionally, in some embodiments, the elongated body 306 is a telescopic elongated body 306 configured to extend and retract as needed (see below), such as Figure 3c As shown. In some embodiments, the length of the elongated body 306 is about 8 cm to about 10 cm (at its maximum extended position when a telescopic mechanism is included); alternatively, it is about 6 cm to about 12 cm; alternatively, it is about 4 cm to about 15 cm.

[0145] Exemplary sensor

[0146] In some embodiments, as described above, the exemplary self-testing device 102 includes one or more sensors. In some embodiments, the exemplary sensors are one or more of the following: a vision sensor (e.g., one or more cameras), an ultrasonic sensor, a temperature sensor, a pressure sensor, a humidity sensor, a pH sensor, a position sensor (e.g., a gyroscope, GPS, etc.), an "electronic nose" sensor, a magnetic resonance imaging (MRI) sensor, and a force sensor.

[0147] In some embodiments, one or more cameras include one or more mechanisms configured to change the camera's field of view, orientation, and / or focus without changing the orientation of the self-testing device 102 itself. In some embodiments, the change in the camera's field of view and / or orientation and / or focus is achieved by moving the camera.

[0148] In some embodiments, the self-testing device 102 includes ultrasound hardware and / or MRI hardware, which works in conjunction with a dedicated guidance system and is configured to enable untrained users to perform specific ultrasound examinations on their own.

[0149] Now for reference Figure 3dThis diagram illustrates an exemplary self-testing device 102 with multiple sensors according to some embodiments of the present invention. In some embodiments, the self-testing device 102 includes a front-facing camera 308, optionally including one or more light sources (not shown). In some embodiments, the front-facing camera is protected by a transparent cover 318 disposed at the farthest end of an elongated body 306. In some embodiments, a portion of the elongated body 306 adjacent to the transparent cover 318 is also transparent. In some embodiments, the front-facing camera 308 is configured to acquire images and / or videos of the internal environment of a subject's body cavity, which may include views of the cervix, posterior fornix, anterior fornix, and a panoramic view of the vagina. In some embodiments, the front-facing camera 318 is located in a fixed position at the farthest end of the elongated body 308 (behind the transparent cover 318).

[0150] In some embodiments, the self-test device 102 may optionally include one or more external cameras 310a-310b, each external camera optionally including one or more light sources (not shown). Figure 3d The diagram shows two external cameras 310a and 310b, both facing forward, i.e., oriented in the same direction as the elongated body 306. One external camera 310a is located on the upper part of the body 304, and the other external camera 310b is located on the lower part of the body 304. In some embodiments, one or more external cameras are configured to acquire images and / or videos of external anatomical structures, which may include panoramic views of the pelvic region and panoramic views of the vulvar vestibule. In some embodiments, the self-testing device 102 includes one external camera.

[0151] In some embodiments, the self-testing device 102 includes one or more sensors 312 located within an elongated body 306, such as temperature sensors, pressure sensors, humidity sensors, pH sensors, and force sensors. In some embodiments, the one or more sensors 312 are configured to acquire medical data from the internal environment of a subject's body cavity.

[0152] Now for reference Figure 3e This diagram illustrates another schematic of an exemplary self-testing device 102 with multiple sensors according to some embodiments of the present invention. Figure 3eAn enlarged view of the distal end of the elongated body 306 and the internal mechanism positioned within the elongated body 306 is shown. In some embodiments, as described above, the self-testing device 102 includes a front-facing camera 308. In some embodiments, the front-facing camera 308 is positioned within the elongated body 306. In some embodiments, a transparent cover 316 at the distal end of the elongated body 306 (and optionally, a transparent portion of the most distal portion of the elongated body 306) is configured such that the front-facing camera 308, disposed within the elongated body 306, provides its achievable field of view. In some embodiments, the front-facing camera 308 is connected to a lateral movement mechanism 320, which is disposed at a handle 302, or at the body 304, or within the elongated body 306. Figure 3e In this embodiment, a lateral movement mechanism 320 is shown at the main body 304. In some embodiments, the front-facing camera 308 is configured to move forward until it contacts the transparent cover 318. In some embodiments, the front-facing camera 308 is configured to move backward relative to the transparent cover 318 by a distance of 0.01 mm to 1 cm. Optionally, it can move backward by a distance of 0.005 cm to about 2 cm. Optionally, it can move backward by a distance of 0.001 cm to about 3 cm.

[0153] In some embodiments, the motorized front-facing camera 308 is configured to provide one or more of the following potential advantages: improved focusing, enhanced image quality in the presence of dirt and / or moisture in the transparent cover 318 (unfocused objects do not affect the image quality of the cervix), and adjustment of the field of view (FOV) to observe more or less lateral wall areas, such as achieving a wider or narrower field of view.

[0154] In some embodiments, providing a motorized front-facing camera 308 can, to some extent, compensate for the uncertainty in the final positioning of the self-test device 102 (e.g., the distance to the cervix). In some embodiments, the field of view (FOV) can be changed by moving the camera (the closer to the cervix, the smaller the field of view, or vice versa), without moving the self-test device 102 itself. In some embodiments, as described above, moving the camera can also adjust the camera's focus (not just move the lens).

[0155] In some embodiments, the motorized front-facing camera 308 is configured to move rearward to allow visualization of the vaginal wall. In some embodiments, the movement of the motorized front-facing camera 308 is used to compensate for / adjust the illumination effects produced by a light source (integrated in the device) and / or optimize reflections.

[0156] In some embodiments, the motorized front-facing camera 308 can be controlled manually by a user and / or automatically by means of intelligent control logic, and / or remotely by a physician.

[0157] In some embodiments, another potential advantage of the front-facing camera 308 is that its axis of motion allows for adjustment of focus and image sharpness along an observation path beginning from the vulva and the outer surface of the perineum, throughout the entire five-step calibration process (which will be described elsewhere in this document). In some embodiments, another potential advantage of the front-facing camera 308 is that its degrees of freedom of movement allow for maximum utilization of a single camera. With only one camera, all the necessary data can be provided without adding more cameras, thus avoiding increasing the outer diameter of the device and reducing image sharpness. Another potential advantage of the front-facing camera 308 is that a single camera configured to rotate 360° can provide all the necessary data without combining photos or videos from multiple cameras to achieve the same effect.

[0158] Exemplary inflation mechanism

[0159] Now for reference Figures 3f-3j This illustration shows a schematic diagram of an exemplary inflatable / inflatable mechanism of an exemplary self-testing device 102 according to some embodiments of the present invention. In some embodiments, an inflatable element 314, such as a balloon, is provided at the distal end of an elongated body 306, configured to inflate / inflate within the internal environment of a subject's body cavity. Figure 3f In the middle, the inflatable element 314 is shown in a collapsed configuration, while Figure 3g In the diagram, the inflatable element 314 is shown in an inflatable configuration. In some embodiments, the inflatable element is used to partition / expand the walls of the body cavity opening to allow the front-facing camera 308 to better observe the internal environment of the body cavity opening; and / or to provide an anchoring mechanism and stability for the self-testing device 102. Referring now to... Figures 3h-3i In some embodiments, an additional second inflatable element 316 is provided, which is disposed at the most distal end of the elongated body 306 and optionally on top of the inflatable element 314, and configured to extend further beyond the first inflatable element 314. In some embodiments, the second inflatable element 316 is used to further separate / expand the walls of the body cavity opening, and also to further anchor and stabilize the self-testing device 102.

[0160] Exemplary automatic / semi-automatic actuation of balloon

[0161] In some embodiments, during operation of the device, one or more balloons are automatically operated to allow the camera to view internal anatomical landmarks (see below). In some embodiments, the system includes dedicated instructions, optionally guided by dedicated AI software, to filter and search for anatomical landmarks based on estimated locations and accordingly actuate one or more balloons to achieve the examination. In some embodiments, the system is semi-automatic, meaning that the system provides instructions to the user to inflate or deflate the balloons. In some embodiments, a potential advantage of using a semi-automatic system is that it can provide a safety mechanism to prevent pain and / or discomfort to the user due to the inflation of one or more balloons. In some embodiments, the one or more balloons are balloons with multiple independent chambers, each of which can be inflated and deflated independently of the other chambers. In some embodiments, a potential advantage of using balloons with multiple independent chambers is that it allows the system to move relevant tissues as needed for clear observation of internal anatomical landmarks.

[0162] Figure 3j A schematic diagram of an exemplary self-testing device 102 is shown, including all the features described above, namely a handle 302, a body 304 with two external cameras 310a, 310b, an elongated body 306 with an internal sensor 312, two inflatable elements 314 / 316, and a front-facing camera 308.

[0163] Exemplary embodiments of inflatable elements

[0164] Now for reference Figures 4a-4q This illustrates exemplary embodiments of an inflatable element according to some embodiments of the present invention.

[0165] In some embodiments, the primary function of the inflatable element is to provide physical separation of the tissue in order to allow a camera (e.g., a front-facing camera) to have a view of the cervix, thereby enabling visual examination.

[0166] In some embodiments, the inflatable element is characterized by one or more of the following features: the type of the inflatable element, the welding type of the inflatable element, and the geometry of the inflatable element.

[0167] Types of inflatable elements

[0168] In some embodiments, the inflatable element is composed of a single inflatable body (hereinafter referred to as "monotype") or multiple inflatable bodies (hereinafter referred to as "multitype").

[0169] Welding type

[0170] In some embodiments, the inflatable element includes a single weld (hereinafter referred to as "single weld type") or includes two or more welds (hereinafter referred to as "multiple weld type").

[0171] Geometric shapes

[0172] In some embodiments, the inflatable element has a uniform expansion geometry, meaning that all portions of the inflatable element expand in the same manner; or it has a non-uniform expansion geometry, meaning that one or more portions of the inflatable element expand in different manner relative to other portions of the same inflatable element. In some embodiments, the non-uniform expansion geometry enables one side of the inflatable element to produce a greater separation (expansion) effect relative to its other sides (see below).

[0173] The following paragraphs will describe several embodiments of the inflatable element, each having a specific set of features described above. It should be understood that the following embodiments are merely exemplary models, intended to help those skilled in the art understand the invention, and should not be construed as limiting the invention in any way.

[0174] Now for reference Figures 4a-4e The diagram illustrates a multi-weld inflatable element according to some embodiments of the present invention.

[0175] Figure 4a A monolithic multi-weld inflatable element 402 with a uniform expansion geometry is shown. In some embodiments, the inflatable element 402 includes a single inflatable body 404 and two welds 406 / 408, which are respectively eccentrically and concentrically arranged, and the inflatable body 404 has a uniform expansion geometry.

[0176] Figure 4b A monolithic multi-weld inflatable element 410 with a non-uniform expansion geometry is shown. In some embodiments, the inflatable element 410 includes a single inflatable body 412 and two welds 406 / 408, which are respectively eccentrically and concentrically arranged, and the inflatable body 412 has a non-uniform expansion geometry.

[0177] It can be seen that the single inflatable body 412 with a non-uniform expansion geometry includes region A, the size of region A after inflation is smaller than that of region B, thereby giving the inflatable body 412 a non-uniform expansion geometry.

[0178] Now for reference Figures 4c-4e An exemplary inflatable element 402, mounted on an elongated body according to some embodiments of the present invention, is schematically shown. In some embodiments, as described above, the inflatable element is mounted on the distal end of the elongated body 306. Figure 4cAn exemplary monolithic multi-weld inflatable element 402 with a uniform expansion geometry in a deflation configuration is shown. Figure 4d An exemplary monolithic multi-weld inflatable element 402 with a uniform expansion geometry in an inflatable configuration is shown. In some embodiments, a characteristic of the multi-weld inflatable element is that the inflatable element is connected to the elongated body 306 at only one connection point, such as at a concentric weld 408, as... Figure 4e As shown in circle 414.

[0179] Now for reference Figures 4f-4k The diagram shows a single-weld-seam inflatable element according to some embodiments of the present invention.

[0180] Figure 4f-4g A monolithic, single-weld inflatable element 416 with a uniform expansion geometry is shown. In some embodiments, the inflatable element 416 includes a single inflatable body 404 (similar to...). Figure 4a (as shown in the diagram) and an eccentrically positioned weld 406, the inflatable body 404 having a uniform expansion geometry. Figure 4f A semi-transparent view of the inflatable body 404 is shown to allow the display of two connecting regions 418 / 420 located concentrically within the inflatable body 404.

[0181] Figures 4h-4i A monolithic, single-weld inflatable element 422 with a non-uniform expansion geometry is shown. In some embodiments, the inflatable element 422 includes a single inflatable body 412 (with... Figure 4b (Similar to the one shown) and an eccentrically positioned weld 406, the inflatable body 412 has a non-uniform expansion geometry.

[0182] It can be seen that the single inflatable body 412 with a non-uniform expansion geometry includes region A, whose inflated size is smaller than region B, thereby making the inflatable body 412 form a non-uniform expansion geometry.

[0183] Figure 4h A semi-transparent view of the inflatable body 412 is shown to allow the view of two connecting regions 418 / 420 concentrically disposed in the inflatable body 412.

[0184] Now for reference Figures 4j-4k An exemplary inflatable element 416, mounted on an elongated body according to some embodiments of the invention, is illustrated. In some embodiments, as described above, the inflatable element is mounted on the distal end of the elongated body 306. Figure 4jA monolithic, single-weld-seam inflatable element 416 with a uniform expansion geometry in an inflatable configuration is shown. In some embodiments, the single-weld-seam inflatable element is characterized in that the inflatable element is connected to an elongated body 306 at two points, for example, at two connection regions 418 / 420, as by... Figure 4k Circles 424 / 426 are shown schematically in the diagram.

[0185] Now for reference Figures 4l-4o The diagram shows a schematic of a multibody inflatable element according to some embodiments of the present invention.

[0186] Figure 4l A multi-body inflatable element 428 with a uniform expansion geometry is shown. In some embodiments, the inflatable element 428 includes a plurality of inflatable bodies 430a-430f, which are optionally interconnected by one or more expansion channels 432a-432c, which are configured to allow all inflatable bodies 430a-430f to inflate simultaneously; the inflatable element 428 has a uniform expansion geometry. In some embodiments, the inflatable bodies 430a-430f are optionally held together by a band 434, which is configured to increase the pressing area of ​​the inflatable element 428 after it has inflated.

[0187] Figure 4m A multi-body inflatable element 436 with a non-uniform expansion geometry is illustrated. In some embodiments, the inflatable element 436 includes a plurality of inflatable bodies 430a-430f, which are optionally interconnected via one or more expansion channels 432a-432c configured to allow all inflatable bodies 430a-430f to inflate simultaneously; by providing one or more inflatable bodies of different sizes, the inflatable element 436 has a non-uniform expansion geometry. Figure 4m In this configuration, two inflatable elements 430a / 430b are larger than the remaining inflatable elements. In some embodiments, optionally, the plurality of inflatable elements 430a-430f are held together by a band 434 configured to increase the pressing area of ​​the inflatable element 436 after it has been inflated.

[0188] It can be seen that the multibody inflatable element 436 with a non-uniform expansion geometry includes two regions A / A' and region B, wherein the dimensions of regions A and A' after inflation are both smaller than those of region B, thereby enabling the inflatable element 436 to form a non-uniform expansion geometry.

[0189] Now for reference Figures 4n-4oAn exemplary inflatable element 436, mounted on an elongated body according to some embodiments of the invention, is illustrated. In some embodiments, as described above, the inflatable element is mounted on the distal end of the elongated body 306. Figure 4n A top perspective view of an exemplary multibody inflatable element 436 with a uniform expansion geometry in an inflatable configuration is shown. Figure 4o A bottom perspective view of an exemplary multibody inflatable element 436 with a uniform expansion geometry in an inflatable configuration is shown.

[0190] Now for reference Figures 4p-4q The diagram illustrates an exemplary inflatable element according to some embodiments of the present invention. In some embodiments, the inflatable element 438 is an inflatable sleeve mounted on an elongated body. Figure 4p A schematic diagram of the inflatable sleeve element 438 in an inflatable configuration is shown, while Figure 4q A schematic diagram of an inflatable sleeve element 438 mounted on an elongated body 306 in an inflatable configuration is shown.

[0191] Exemplary Overview of an Exemplary Self-Test Device

[0192] Now for reference Figure 5 The figure shows a cross-sectional view of an exemplary self-testing device according to some embodiments of the present invention. The same reference numerals are used for the same parts as in the foregoing figures. The exemplary self-testing device 500 includes a handle 302 and an elongated body 306. A transparent protective cover 318 is provided at the distal end of the elongated body 306. The exemplary self-testing device 500 includes an internal front-facing camera 308, which is configured to move within the elongated body 306 using a movable bracket 502 connected to a dedicated motor 504. Figure 5 A wire 506 for the internal front-facing camera 308 is shown, extending proximally toward the handle 302. An exemplary self-test device 500 includes an inflatable element 416, which in this example is a monolithic, single-weld inflatable element 416 having a uniform expansion geometry. The exemplary self-test device 500 includes an electronic module (generally shown as 506) and a battery 508. It should be understood that... Figure 5 The examples shown are merely non-limiting examples, and the components therein may be replaced with corresponding components in other embodiments described herein, such as different types of inflatable elements, retractable elongated bodies, one or more external cameras, and multiple sensors.

[0193] Exemplary apparatus and methods for assessing distance

[0194] Now for reference Figures 6a-6c The diagram illustrates exemplary apparatus and methods for assessing distances during an inspection process, according to some embodiments of the present invention.

[0195] In some embodiments, distance is measured and monitored by a laser sensor, such as using a laser diode (e.g., as small as 0.5 mm) and a lens for focusing the laser to form a collimated beam.

[0196] Now for reference Figures 6a-6b This illustrates a schematic diagram of laser triangulation according to some embodiments of the present invention. Figures 6a-6b The image shows a partial view of the slender main body 306, the internal front-facing camera 308, and the transparent protective cover 318. Additionally, the laser 602 and the dedicated lens 604 are visible. The device is positioned at a certain distance in front of the cervix 606. Figure 6a The distance in is greater than Figure 6b (Distance in the middle). The figure also schematically illustrates the camera's field of view (FOV) 608 and laser beam trajectory 610. In some embodiments, if the device is too far from the target (cervix 606), the laser spot 612 observed by the camera will not be centered in the field of view (FOV), for example, as... Figure 6a As shown, laser spot 612 is located above the center of the field of view. In this example, the location of laser spot 612 indicates that the device is still relatively far from the target. In some embodiments, when laser spot 612 is located at the center of the field of view (FOV), for example as... Figure 6b As shown, this means that the device has reached the desired distance from the target.

[0197] In some embodiments, the distance is calculated by calculating the projection angle of the laser and the known position of the camera. Using these two parameters, the distance D can be calculated. Therefore, when the laser spot 612 is located at the center of the field of view (FOV), it indicates that the distance between the device and the target is D.

[0198] Now for reference Figure 6c This illustrates a variation of an embodiment of distance measurement using a laser according to some embodiments of the present invention. In some embodiments, when using a laser, the user and / or system (automatically) detects the correct distance by moving the device until the laser spot moves to the center of the field of view (FOV).

[0199] In some embodiments, multiple lasers may be used arranged around the front-facing camera 308. In some embodiments, when multiple lasers are used, the user and / or system (automatically) detects the correct distance by moving the device until all laser spots are moved to the center of the field of view (FOV). In some embodiments, these methods may be used to measure the actual absolute distance and / or to detect whether the device is at the correct distance. In some embodiments, a single laser may also be used, and the lens may be replaced with a diffuser (causing the laser to form multiple spots, i.e., speckle, across the entire surface of the cervix), and the software may determine the distance by analyzing the degree of speckle diffusion.

[0200] In some embodiments, the laser automatically turns on every X seconds (e.g., every 0.5 seconds, 1 second, 2 seconds) to check the distance to the target. In some embodiments, the laser's on-time can be set very short relative to the camera's frame rate, so that the user will hardly notice the laser's activation while watching the video. In some embodiments, another approach is to keep the laser on until the appropriate distance is reached, and then turn it off once the appropriate distance is reached, to improve image quality.

[0201] Exemplary GUI

[0202] In some embodiments, an exemplary graphical user interface (GUI) includes one or more control buttons that allow a user to activate the self-test device 102 and execute corresponding control commands, such as inflating / deflating inflatable elements, extending / retracting the elongated body 306, and activating / deactivating individual sensors and / or cameras. In some embodiments, the GUI may include a digital display screen for providing visual cues to the user. In some embodiments, the GUI may not include a digital display screen and may only include a user interface (UI). In some embodiments, the GUI may include a speaker configured to provide voice commands (see below) and / or prompts (e.g., beeps). In some embodiments, the GUI may include one or more indicator lights configured to provide corresponding signal indications to the user for specific operations of the self-test device 102. In some embodiments, the GUI is provided as an application (App) on an electronic device, such as a mobile phone, tablet computer, or a dedicated electronic device provided as part of the self-test device 102.

[0203] Exemplary methods

[0204] Exemplary boot system

[0205] In some embodiments, the self-test device 102 includes dedicated software configured to guide the user during the self-test process, including the calibration process and / or the self-test process itself. In some embodiments, the guidance includes one or more of the following methods: voice guidance (e.g., providing voice commands through one or more speakers), video guidance (e.g., guidance via video displayed in a GUI), and light guidance (e.g., indicating whether an operation was successful via indicator lights).

[0206] Exemplary calibration method

[0207] In some embodiments, when using the self-test device 102, the system may optionally require calibration of the user's anatomical landmarks before medical data acquisition begins. Now refer to Figure 7a The diagram schematically illustrates an external view of the vulvar region. In some embodiments, the anatomical landmarks include one or more of the following: mons pubis, clitoral hood, clitoris, labia majora, labia minora, urethra, hymen, vagina, perineum, and anus.

[0208] Now for reference Figure 7b It shows a schematic diagram of external anatomical landmarks as seen from the upper external camera 310a of the self-testing device 102 according to some embodiments of the present invention. Figure 7c A schematic diagram is shown of external anatomical landmarks as observed from the viewpoint of a lower external camera 310b of a self-testing device 102 according to some embodiments of the invention. In some embodiments, the external camera is configured to capture images of the protruding elongated body 306 within its field of view.

[0209] In some embodiments, when only one external camera is provided, the user is guided to rotate the device approximately 180° so that the external camera is positioned once at the top of the device and once at the bottom of the device.

[0210] In some embodiments, an exemplary calibration method includes the automatic identification of external anatomical landmarks. In some embodiments, an exemplary self-executing inspection system 100 utilizes automatic identification software (optionally enhanced with artificial intelligence (AI) capabilities) to perform the calibration process (see below for an example of using AI for an automatic identification process).

[0211] In some embodiments, an exemplary calibration method includes guided recognition of external anatomical landmarks. In some embodiments, when the camera is activated, the system is configured to guide the user to recognize one or more external anatomical landmarks, for example, by asking the user to point to a particular anatomical landmark (e.g., by pointing to the landmark with a finger); or by asking the user to confirm external anatomical landmarks automatically recognized by the system. For example, the system automatically recognizes the clitoris, then displays the recognized clitoris to the user via a GUI, and requests the user to confirm that the recognized object is indeed the clitoris. In some embodiments, if the automatic recognition result is incorrect, the system is configured to provide alternative external anatomical landmarks.

[0212] See now Figures 8a-8d This document illustrates a flowchart of an exemplary method for performing external calibration from a system perspective according to some embodiments of the present invention. In some embodiments, the exemplary method for performing external calibration includes one or more of the following operations:

[0213] In some embodiments, the system requests the user to position the self-test device 102 in front of the vulvar area (802).

[0214] In some embodiments, the system receives confirmation from the user that the self-test device 102 is located in front of the vulvar area (804).

[0215] In some embodiments, upon receiving confirmation from the user, the system begins acquiring images and / or video (hereinafter collectively referred to as "visual data") from external cameras 310a and 310b (806). In some embodiments, during calibration, the system may optionally utilize all cameras, including the front-facing camera 308. In some embodiments, when only one external camera is set, the user is guided to rotate the device approximately 180° so that the external camera is positioned once at the top of the device and once at the bottom of the device.

[0216] In some embodiments, the system then analyzes the visual data (808).

[0217] In some embodiments, the system automatically identifies one or more external anatomical landmarks (810).

[0218] In some embodiments, the system determines whether at least one external anatomical landmark has been successfully identified / identified (i.e., the system has completed the identification, but it has not yet been confirmed by the user) (812).

[0219] In some embodiments, if the answer is "yes", then (the flowchart continues via the letter "A" to...) Figure 8b If only one external anatomical landmark is identified, the system requires the user to confirm the identification result of the first identified external anatomical landmark (814); if only one external anatomical landmark is identified, the system requires the user to confirm the identification result of the unique identified external anatomical landmark.

[0220] In some embodiments, the system determines whether the automatic identification is correct based on the input provided by the user (816).

[0221] In some embodiments, if the automatic identification is correct, the system saves the identification result of the external anatomical landmark in a database as part of the user's personalized database (818). In some embodiments, the correctly identified external anatomical landmark can be used in subsequent examinations to expedite the calibration process.

[0222] In some embodiments, if other external anatomical landmarks are identified, the system repeats operations 814 and 816 until all automatic identification results are confirmed by the user (820).

[0223] In some embodiments, if the automatic identification result is incorrect, the system prompts the user to indicate the name of the identified external anatomical landmark (822).

[0224] In some embodiments, the system receives user input (824).

[0225] In some embodiments, the system then proceeds to operation 818, which involves saving the identification results of the external anatomical landmark in a database as part of the user's personalized database.

[0226] The flowchart continues from the letter "C" to... Figure 8c .

[0227] In some embodiments, the system then determines whether a minimum number of external anatomical landmarks have been identified (826).

[0228] In some embodiments, if the answer is "no", the system repeats operation 810 and its subsequent operations until the judgment result of operation 826 is "yes" (828).

[0229] In some embodiments, if the answer is "yes", the system may begin to perform an external inspection process (see below) (830).

[0230] return Figure 8a If the answer is "no", then (the flowchart continues via connector "B" to...) Figure 8d The system requires the user to identify the first specific external anatomical landmark (832).

[0231] In some embodiments, the system receives confirmation from the user that a first specific external anatomical landmark is being pointed out (834).

[0232] In some embodiments, the system continues to execute at this time. Figure 8aThe operation 806 and subsequent operations are performed until the calibration process is completed (836).

[0233] See now Figure 9 This document illustrates a flowchart of an exemplary method for performing external calibration from a user's perspective, according to some embodiments of the present invention. In some embodiments, the exemplary method for performing external calibration includes one or more of the following operations:

[0234] In some embodiments, the user turns on the self-test device 102 (902).

[0235] In some embodiments, the user positions the self-testing device 102 in front of the vulvar area (904).

[0236] In some embodiments, the user sends confirmation (906) that the self-test device 102 is located in front of the vulva area.

[0237] In some embodiments, two situations may occur: the self-testing device 102 successfully identifies at least one external anatomical landmark, or it fails to identify an external anatomical landmark.

[0238] If the self-testing device 102 successfully identifies at least one external anatomical landmark:

[0239] In some embodiments, the user receives a request (908) to confirm the identification of external anatomical landmarks.

[0240] In some embodiments, the user confirms (910) or denies (912) the identification of external anatomical landmarks.

[0241] In some embodiments, if the user denies the identification result, the user is asked to re-identify the identified external anatomical landmark (914).

[0242] In some embodiments, the user provides the correct identification of the external anatomical landmark (916).

[0243] In some embodiments, the system then instructs the user to continue with the medical examination (see below) (918).

[0244] In some embodiments, if the user confirms the identification result (910), the system also instructs the user to continue with the medical examination (see below) (918).

[0245] If the self-testing device 102 fails to identify at least one external anatomical landmark:

[0246] In some embodiments, the user receives a request (920) to indicate a first specific external anatomical landmark.

[0247] In some embodiments, the user points to a first specific external anatomical landmark (922).

[0248] In some embodiments, the user uses the GUI to confirm to the self-testing device 102 that the first specific external anatomical landmark (924) is being pointed out.

[0249] In some embodiments, the user is then instructed to continue the medical examination (918), or the calibration process continues from operation 908.

[0250] Exemplary internal calibration

[0251] In some embodiments, similar to the external calibration described above, internal calibration is performed. In some embodiments, such as Figures 10a-10b As shown, the slender body 306 of the self-testing device 102 is inserted into the human body cavity.

[0252] In some embodiments, once inserted into a body cavity, a front-facing camera is used to visualize the internal environment of the body cavity. Figure 10c The possible field of view (FOV) of the front-facing camera 308 is schematically shown. It should be understood that the actual FOV is determined by the anatomical constraints of the specific user. In some embodiments, the front-facing camera 308 may capture images / videos at any time during the insertion of the elongated body 306. For example, the front-facing camera 308 may operate from the start of the insertion action until the end of the insertion action, thereby providing images / videos of the entire vagina. In some embodiments, the front-facing camera 308 is configured to visualize, for example, the anterior fornix, posterior fornix, cervix, and any medical conditions occurring within the internal environment of the body cavity (see below).

[0253] In some embodiments, similar to the above, internal calibration is performed, the only difference being that the system no longer identifies external anatomical landmarks, but instead searches for internal anatomical landmarks, such as one or more of the anterior fornix, posterior fornix, and cervix, as previously described.

[0254] Exemplary 5-step calibration method

[0255] In some embodiments, the calibration process is divided into 5 different steps:

[0256] Step 1: Identify the following upper external anatomical landmarks: right labia majora, right labia minora, clitoris, and urethra.

[0257] Step 2: Identify the following lower external anatomical landmarks: right labia minora, left labia minora, perineum, vaginal opening, and anus.

[0258] Step 3: Identify the vagina and cervix – optionally actuate one or more balloons.

[0259] Step 4: Identify the posterior fornix - optionally actuate one or more balloons.

[0260] Step 5: Identify the anterior fornix - optionally actuate one or more balloons.

[0261] Exemplary self-testing method

[0262] In some embodiments, as described above, the self-examination device 102 is used to allow untrained users to perform gynecological self-examinations. In some embodiments, the examination includes one or more of the following: visual examination of external areas, visual examination of internal areas (e.g., the vagina), ultrasound examination, and examination of physiological parameters (e.g., temperature, pH, humidity, etc.). In some embodiments, the system is configured to allow the user to perform each type of examination by providing detailed instructions to the untrained user. In some embodiments, each operation is monitored to assess the success of the process; once the success of a given operation is confirmed, the system can proceed to the next operation.

[0263] Exemplary external / internal inspection

[0264] In some embodiments, after the calibration process is complete, the system begins to provide instructions to the user, allowing the system to collect all relevant medical data. (See now for reference.) Figure 11 It illustrates an exemplary method flowchart for performing external and / or internal self-tests according to some embodiments of the present invention.

[0265] In some embodiments, exemplary external and / or internal checks include one or more of the following operations:

[0266] In some embodiments, the method includes: using one or more external cameras when the examination is an external examination; or using a front-facing camera when the examination is an internal examination, automatically acquiring one or more images and / or videos of one or more external / internal anatomical landmarks (1102). In some embodiments, during an internal examination, one or more sensors are used to acquire medical data.

[0267] In some embodiments, the method includes automatically assessing whether all required images and / or videos (or general medical data) of all necessary external and / or internal anatomical landmarks have been acquired (1104).

[0268] In some embodiments, the method includes automatically saving images and / or videos (medical data) in memory and / or a database (1106).

[0269] In some embodiments, the method includes automatically analyzing images and / or videos (medical data) (1108).

[0270] In some embodiments, the method includes automatically identifying one or more attributes (1110) associated with external / internal anatomical landmarks based on the analysis results. In some embodiments, the attribute is assigned a numerical value (quantitative and / or qualitative) for further analysis. Exemplary attributes include one or more of the following: skin color, morphology of anatomical landmarks, skin surface condition, markings on the skin, texture, skin elasticity, and specific odor (specific particles).

[0271] In some embodiments, the method includes automatically comparing the identified attributes with predetermined attributes (1112). In some embodiments, the predetermined attributes are based on a preliminary examination previously performed on the same subject. In some embodiments, the predetermined attributes are manually added and / or revised by a specialized medical professional (e.g., a gynecologist).

[0272] In some embodiments, the method includes automatically identifying differences between compared attributes based on a predetermined attribute threshold (1114). In some embodiments, the threshold is a quantitative and / or qualitative value provided by the system and / or by a dedicated medical professional, used to distinguish between a state where the attribute's state has not actually changed and a state where the attribute's state has actually changed. For example, using the Fitzpatrick Skin Typing Scale (see the example table of the Fitzpatrick Skin Typing Scale shown below, which illustrates the correspondence between the six categories of the Fitzpatrick Skin Typing Scale and the 36 categories of the earlier von Luschan scale) to assess skin color, and during an initial examination, the skin color is assigned the value "fair," while during a self-examination, the attribute is identified as "olive, medium brown," which may indicate a medical problem.

[0273] In some embodiments, the method includes: automatically generating a preliminary diagnosis based on differences identified between comparative attributes (1116). In some embodiments, the system is configured to retrieve possible diagnostic results from a dedicated database that match the type and magnitude of a particular attribute change. For example, following the example above regarding skin color, the database might suggest a rash, a type of dermatitis, and / or a type of vaginitis.

[0274] In some embodiments, the method includes automatically sending the preliminary diagnosis and related data to a designated medical professional (1118).

[0275]

[0276] Exemplary general methods

[0277] Now for reference Figure 12 The diagram illustrates a flowchart of an exemplary general method according to some embodiments of the present invention. In some embodiments, the exemplary general method includes one or more of the following operations:

[0278] 1. A power-on device (1202). In some embodiments, the power-on device may optionally cause the device to start recording video to a built-in memory and to capture images at time intervals of less than 1 second, the captured images being optionally high-resolution images.

[0279] 2. Position the device in front of the vaginal opening (1204). In some embodiments, the device saves images of the vulva and perineum for the first few seconds.

[0280] 3. Insert the device into the vagina (1206). In some embodiments, insertion is performed slowly and monitored by one or more sensors. In some embodiments, if insertion is too fast, the system will notify the user to adjust the insertion speed. In some embodiments, upon entry into the vagina, the device captures images and / or video of the vagina and its sidewalls. In some embodiments, the images and / or video may be recorded in one or more of the following ways: using a front-facing camera, optionally with a wide field of view; using a side-facing camera; and tilting the front-facing camera to one side and optionally rotating it 360° to achieve 360° coverage.

[0281] 4. Provide an indication that the device has reached the final desired / expected position (1208). In some embodiments, the device itself provides the indication. In some embodiments, the indication includes one or more of light, sound, and images on the electronic device. In some embodiments, the device detects that it has reached the final desired / expected position (cervical position), optionally the optimal position, using one or more of the following methods:

[0282] a. Manually push the device to the end of the vagina until the protective transparent cover of the device contacts the cervix;

[0283] b. The camera identifies the five-step calibration mark by displaying the anterior and posterior fornixes;

[0284] c. Detecting the cervix using a front-facing camera; and

[0285] d. The user and / or doctor / physician see the live stream video and identify the cervix.

[0286] 5. Inflate the balloon (1210). In some embodiments, the balloon is manually inflated by the user / doctor and / or automatically inflated by the system. In some embodiments, the balloon is continuously inflated until one or more of the following conditions are met: maximum size; user manually stops inflation; the balloon reaches a predetermined pressure level.

[0287] 6. Capture video and / or images (1212). In some embodiments, the camera continues to capture video and / or images after the balloon reaches its final diameter.

[0288] 7. Depress the balloon (1214). In some embodiments, if the user pulls out the device at any stage of balloon inflation or after inflation, a microswitch in the device detects the pull and automatically deflates the balloon. In some embodiments, the balloon is manually deflated.

[0289] 8. Pull the device out of the vagina (1216).

[0290] An example of an automated recognition process using AI

[0291] In some embodiments, as described above, the system is configured to receive medical data information, analyze it, and provide a preliminary diagnosis. In some embodiments, the system utilizes artificial intelligence (AI) enhancement technology to learn and improve the system's diagnostic capabilities. In some embodiments, the system is provided with multiple images, videos, and / or related medical data associated with healthy individuals to establish an appropriate database of predetermined attributes and attribute values ​​for healthy individuals, which will be used as a reference for future examinations (health reference). In some embodiments, the system is provided with multiple images, videos, and / or related medical data associated with various diseases to establish an appropriate database of predetermined attributes and attribute values ​​for diseased individuals, which will be used as a reference for future examinations (disease reference). In some embodiments, optionally, when a user first obtains the self-testing device 102, the user is requested to perform an initial self-test in a healthy state to establish a baseline (health baseline), which will serve as a benchmark for subsequent self-tests. In some embodiments, the health baseline is compared with the health reference database to establish a correspondence between the user's health status and the health reference; when a change in a relevant attribute is detected, the correspondence will be used by the system to generate a preliminary diagnosis.

[0292] Exemplary methods for assessing pelvic organ prolapse

[0293] In some embodiments, as part of a self-testing process, the system is configured to assess whether a user has pelvic organ prolapse.

[0294] It is reported that approximately 23.7% of women experience some form of pelvic floor dysfunction. Common problems include urinary incontinence (see below) and various types of pelvic organ prolapse (POP). "Prolapse" refers to the downward or forward displacement of a part or organ of the body due to weakened or stretched connective tissue.

[0295] Typical types of pelvic organ prolapse (POP) include (excerpted from https: / / www.advancedgynecology.com / 2020 / the-major-types-of-pelvic-organ-prolapse-and-their-differences / ):

[0296] cystocele - The prolapsed bladder descends into the anterior vaginal wall.

[0297] Cystocele (also known as bladder prolapse) is the most common type of pelvic organ prolapse in women and one of the few types that can affect bladder function. Essentially, the supporting tissues of the bladder loosen due to traction or separate from the surrounding tissues, causing the bladder to droop and protrude towards the anterior wall of the vagina (the top of the vagina). This can lead to symptoms such as difficulty urinating, urinary incontinence, painful intercourse, or general discomfort.

[0298] urethral prolapse - The prolapsed urethra descends into the anterior vaginal wall.

[0299] This is another type of prolapse affecting the anterior vaginal wall. This type of prolapse only affects the urethra, the tube that carries urine out of the bladder. It can lead to urinary incontinence, as well as urinary frequency or urgency.

[0300] cystocele - Cystocele (bladder prolapse) and urethrocele (urethral prolapse) occur simultaneously.

[0301] This type of bladder prolapse affects both the bladder and urethra, with both descending together to the anterior vaginal wall.

[0302] Uterine prolapse - The uterus prolapses into the vaginal cavity, and in severe cases, it may even protrude outside the vaginal opening.

[0303] The uterus is a strong muscular organ that stretches during pregnancy and childbirth, but uterine prolapse can cause quite a few problems. Because of its weight, the uterus puts pressure on other, weakened pelvic organs, causing them to prolapse further and potentially leading to other types of pelvic organ prolapse mentioned in this list. If uterine prolapse remains untreated for a long time, the uterus may protrude completely outside the vaginal opening, a condition known as procidentia. Uterine prolapse can cause a feeling of sitting on a ball, bleeding, and pain during intercourse.

[0304] Vaginal vault prolapse - The top of the vaginal wall droops downwards towards the vaginal cavity.

[0305] This type is common in women who have undergone a hysterectomy. Because the uterus has been removed, there is no longer any structure holding the top of the vagina or the cervix in place, so it may sometimes sag. In very severe cases, the vagina may prolapse from the vaginal opening.

[0306] Vaginal prolapse - The vagina itself descends vertically to protrude from the body.

[0307] Vaginal prolapse differs slightly from vaginal vault prolapse. This refers to the vagina and its surrounding ligaments, muscles, and skin appearing to sag and deviate from their normal position. This type of prolapse often occurs simultaneously with other types of prolapse listed in this document.

[0308] Small intestine prolapse - The small intestine prolapses onto the upper wall of the vagina.

[0309] In some cases, the small intestine or ileum may descend into the lower pelvic cavity, thus affecting the top of the vagina.

[0310] Rectocele - The rectum bulges into the posterior vaginal wall.

[0311] This type of rectal prolapse only affects women, where the posterior wall of the vagina (the normal thick band of muscle between the vagina and rectum) is weakened. In severe cases, this prolapse may further protrude into the vagina. Earlier stages may cause rectal pain, constipation, a feeling of pressure in the rectum, or a feeling of incomplete bowel emptying after defecation.

[0312] rectal prolapse - The rectum prolapses and protrudes through the anus.

[0313] The tissues and muscles surrounding the rectum become lax, and the rectum may eventually prolapse through the anus. Patients may experience symptoms such as fecal incontinence, urgency to defecate, or bleeding or mucus discharge from the anus.

[0314] Perineal descent syndrome- The perineum is lowered below its normal position in the pelvis.

[0315] Excessive trauma to this area can lead to perineal prolapse. The perineum is the area located between the vulva and the anus. This type of pelvic floor prolapse affects the entire perineal area, causing it to bulge downwards beyond its normal position, which is normally within the bony structure of the pelvis.

[0316] All of these types of prolapse have many potential causes. Pregnancy, childbirth, menopause, hysterectomy, excessive lifting of heavy objects, smoking, weight, chronic diseases that cause constipation, chronic diseases that cause frequent coughing or straining, age, and certain conditions (such as Marfan syndrome) can all increase the risk of different types of pelvic organ prolapse.

[0317] In some embodiments, during a self-examination, the system is configured to collect relevant medical data to determine whether the user has any of the aforementioned types of pelvic organ prolapse.

[0318] For example, the system is configured to assess pelvic organ prolapse using the Pelvic Organ Prolapse Quantitative (POP-Q) staging system.

[0319] POP-Q is a system for assessing the degree of pelvic organ prolapse, designed to standardize clinical diagnosis, comparison, documentation, and sharing of clinical findings. This assessment method is the most widely used tool in the literature on pelvic organ prolapse research. It is the most frequently used assessment in publications related to pelvic organ prolapse. When assessed using POP-Q, the prevalence of pelvic organ prolapse is estimated to be as high as 50%; compared to only 3%–6% when diagnosed based on symptoms. POP-Q quantifies the degree of descent of pelvic organs into the vagina. The system provides a reliable description of the support status of the anterior, posterior, and apical (fornix) vaginal walls. POP-Q uses an objective and precise distance measurement method with the hymen as a reference point. Cystic prolapse and vaginal prolapse from other causes can be staged according to the POP-Q criteria, ranging from well-supported (no descent into the vagina observed), i.e., POP-Q stage 0 or I, to POP-Q stage IV (including prolapse beyond the hymenal plane). This system can also be used to quantify the displacement of other structures into the vaginal cavity and the extent of their descent.

[0320] Now for reference Figure 13a This shows a schematic diagram of the location of the POP-Q system.

[0321] In some embodiments, the following measurement parameters are used in the POP-Q test:

[0322] The plane of the hymen is defined as the zero point, and all measurements are in centimeters, located either above / proximal to the hymen (negative) or below / distal to the hymen (positive). The measurement parameters consist of six distinct points (Aa, Ba, C, D, Ap, Bp):

[0323] Point Aa is located at the midline of the anterior vaginal wall. In the absence of prolapse, this point is located 3 cm above the hymen (only inside the vaginal opening). The parameter relative to the hymen can be -3 cm, indicating no anterior vaginal wall prolapse; or +3 cm, indicating complete prolapse.

[0324] Point Ba refers to the distal end of the upper remnant of the anterior vaginal wall. In women without anterior wall prolapse, this location coincides with point Aa (-3 cm). However, in women with complete prolapse, this location coincides with point C. In severe cases, its location can vary from -3 cm to +6 cm or +7 cm.

[0325] Point C is the lowest edge of the cervix or the vaginal fornix (i.e., the scar after a hysterectomy). This location is used to determine whether the cervix has descended.

[0326] Point D is the uppermost point of the posterior vaginal wall. This location can be compared with point C to assess whether the cervical inlet has been elongated.

[0327] The Ap point is located on the midline of the posterior vaginal wall, about 3 cm proximal to the hymen. The parameters of this point relative to the hymen can vary from -3 cm to +3 cm.

[0328] The BP point is located at the distal end of the upper segment of the posterior vaginal wall remnant. In cases of severe prolapse, its measurement relative to the hymen ranges from -3 cm to +6 cm or +7 cm.

[0329] In addition, three anatomical landmarks (GH, PB, TVL) can be examined:

[0330] GH stands for "genital cleft," which is used to record the distance from the external urethral orifice to the posterior vaginal opening / hymen. This cleft refers to the opening in the puborectalis muscle, which is part of the levator ani muscle group. An increased distance at this point may indicate laxity in that area.

[0331] PB stands for "perineal body," which is used to record the distance from the posterior edge of the hymen to the midpoint of the anal opening. This distance can be used to assess the tension of the superficial pelvic floor muscles. During vaginal delivery, the perineal body may be damaged due to tearing or episiotomy.

[0332] TVL refers to the total length of the vagina, measured from the hymen to its furthest point. Understanding this parameter helps in assessing the depth of prolapse and in subsequent evaluations after surgical repair.

[0333] As described above, the POP-Q assessment tool measures nine points in the vagina. The hymen serves as a reference point, and all other measurements are compared to it. The position of the prolapsed organ is measured in centimeters relative to the hymen. Anatomical landmarks used include the anterior vaginal wall, cervix, hymen, perineal body, total vaginal length, posterior vaginal wall, and posterior vaginal fornix. A 3×3 cm recording table is used to record proximal and distal values. The information in this table is then converted into the corresponding prolapse stage.

[0334] Exemplary installment plans include:

[0335]

[0336] Figure 13b and Figure 13c A schematic diagram illustrating an exemplary measurement of an organ is shown.

[0337] Exemplary method for performing measurements using this system

[0338] In some embodiments, as described above, the POP-Q assessment is performed by taking multiple measurements between preset anatomical landmarks. In some embodiments, the system is configured to perform the multiple measurements using one or more of an elongated body 306, a front-facing camera 308, one or more external cameras 310a-310b, and optionally one or more sensors 204. In some embodiments, as described above, the self-test device 102 includes an elongated body 306, which may optionally be a telescopic elongated body. The following description will relate to embodiments in which the elongated body 306 has a fixed length, and further description regarding telescopic elongated bodies will be provided after these descriptions.

[0339] An exemplary method using a self-testing device 102 including an elongated body 306 of fixed length.

[0340] See Figure 14 The diagram illustrates an exemplary self-testing device 102 for performing measurements according to some embodiments of the present invention. In some embodiments, the system utilizes multiple distances and / or relationships between distances to perform measurements required for POP-Q evaluation. In some embodiments, the distances used by the system include one or more of the following:

[0341] 1. The length of the elongated body 306 is defined as D1. In some embodiments, D1 is also equal to the distance between one or more external cameras 310a-310b and the front camera 308.

[0342] 2. The estimated distance and / or measured distance between the front-facing camera 308 and a certain marker captured within the field of view (FOV) of the front-facing camera 308 is defined as D2.

[0343] 3. The estimated distance and / or measured distance between one or more external cameras 310a-310b and a landmark captured within the field of view (FOV) of the one or more external cameras 310a-b is defined as D3.

[0344] 4. The sensing / measuring distance obtained by the motion self-test device 102, for example measured by the sensor 204 (e.g., accelerometer), is defined as D4.

[0345] Now for reference Figures 15a-15b A flowchart illustrating an exemplary method for performing a POP-Q evaluation by a system according to some embodiments of the present invention is shown. In some embodiments, the exemplary method for performing a POP-Q evaluation includes one or more of the following operations:

[0346] 1. Setting the position of a reference anatomical landmark (e.g., the hymen) (1502). In some embodiments, the position of the reference anatomical landmark is set by identifying the hymen using one or more front-facing cameras 308 and one or more external cameras 310a-310b. In some embodiments, if the anatomical landmark is identified only by the front-facing camera 308, the position of the anatomical landmark relative to the device can be determined using, for example, distances D1 and D2. In some embodiments, if the anatomical landmark is identified by one or more external cameras 310a-310b, the position of the anatomical landmark relative to the device is D3. It should be understood that any combination of the above-described distance measurements can be used to set the position of the anatomical landmark relative to the device.

[0347] 2. Move the elongated body 306 (1504) within the human body cavity and generate a data acquisition timeline while performing the movement.

[0348] 3. While moving the slender body 306 within the human body cavity opening (1506), perform multiple data acquisitions, including one or more of the following:

[0349] a. Use the front-facing camera 308 to acquire multiple images and / or videos.

[0350] b. Acquire multiple images and / or videos using one or more external cameras 310a-310b.

[0351] c. Acquire multiple sensing data from one or more sensors 204.

[0352] 4. Correlate the acquired data with the data acquisition timeline (1508).

[0353] 5. Analyze the collected data to identify further required anatomical landmarks (1510).

[0354] 6. Calculate the distance (1512) between the front-facing camera 308 and the newly identified anatomical landmark. (Flowchart continues along the letter "D" to...) Figure 15b )

[0355] 7. Based on the results of the previously performed calculations, calculate the distance between the reference anatomical landmark and the newly identified anatomical landmark (1514).

[0356] 8. The measured distance between the reference anatomical landmark and the newly identified anatomical landmark is compared with the distance values ​​stored in the reference database (1516).

[0357] 9. Based on the comparison, assess whether the measured distance between the reference anatomical landmark and the newly identified anatomical landmark is below or above a predetermined threshold (1518).

[0358] 10. Generate diagnostic results based on the assessment (1520). In some embodiments, the diagnostic results are generated based on predetermined diagnostic results pre-stored in a database, corresponding to different possible measurement results of the various measurements required for the POP-Q assessment.

[0359] In some embodiments, the diagnostic results are sent to designated medical personnel for further evaluation and confirmation.

[0360] An exemplary method using a self-testing device 102 including a telescopic elongated body 306 with variable length.

[0361] Now for reference Figure 16 The diagram illustrates an exemplary self-testing device 102 for performing measurements according to some embodiments of the present invention. In some embodiments, as disclosed above, the system utilizes multiple distances and / or relationships between distances to perform the measurements required for POP-Q evaluation. In some embodiments, the distances used by the system are one or more of the following:

[0362] 1. The length of the telescopic elongated body 306 is defined as D1'. In some embodiments, the system presets a maximum distance value for D1' (also called D1'max), which is equal to the maximum length to which the telescopic elongated body can extend. In some embodiments, D1' max = D1. In some embodiments, the system also presets a minimum distance value for D1' (also referred to as D1'). minThe value of D1' is equal to the minimum length to which the telescopic elongated body can retract. In some embodiments, at any given time, the value of D1' is also equal to the distance between one or more external cameras 310a-310b and the front-facing camera 308. In some embodiments, the system is configured to be able to know the actual value of D1' at any time when the telescopic elongated body 306 is actuated.

[0363] 2. The estimated distance and / or measured distance between the front-facing camera 308 and an anatomical landmark captured within the field of view (FOV) of the front-facing camera 308 is defined as D2.

[0364] 3. The estimated distance and / or measured distance between one or more external cameras 310a-310b and an anatomical landmark captured within the FOV of one or more external cameras 310a-b is defined as D3.

[0365] 4. The sensing distance / measurement distance obtained by the motion self-test device 102, for example measured by the sensor 204 (e.g., accelerometer), is defined as D4.

[0366] Now for reference Figures 17a-17b A flowchart illustrating an exemplary method for performing a POP-Q evaluation by a system according to some embodiments of the present invention is shown. In some embodiments, the exemplary method for performing a POP-Q evaluation includes one or more of the following operations:

[0367] 1. When the slender body is fully retracted (i.e., D1') min In the case of a hymen, the location of a reference anatomical landmark (e.g., the hymen) is set (1702). In some embodiments, the location of the reference anatomical landmark is set by identifying the hymen using one or more front-facing cameras 308 and one or more external cameras 310a-310b. In some embodiments, if the anatomical landmark is identified only by the front-facing camera 308, a distance such as D1' can be used. min The position of the anatomical landmark relative to the device is determined by distance D2. In some embodiments, if the anatomical landmark is identified by one or more external cameras 310a-310b, the position of the anatomical landmark relative to the device is distance D3. It should be understood that any combination of the above distance measurements can be used to set the position of the anatomical landmark relative to the device.

[0368] 2. Move the distal end of the slender body 306 within the human body cavity opening (1704).

[0369] 3. Actuate the telescopic mechanism to cause the elongated body to move from D1' min Move to D1' maxAnd while performing the actuation, a data acquisition timeline (1706) is generated.

[0370] 3. While the actuated elongated body 306 moves within the human body cavity opening (1708), multiple data acquisitions are performed, including one or more of the following:

[0371] a. Use the front-facing camera 308 to acquire multiple images and / or videos.

[0372] b. Acquire multiple images and / or videos using one or more external cameras 310a-310b.

[0373] c. Acquire multiple sensing data from one or more sensors 204.

[0374] 4. Correlate the acquired data with the data acquisition timeline (1710).

[0375] 5. Analyze the collected data to identify additional required anatomical landmarks (1712).

[0376] 6. Calculate the distance (1714) between the front-facing camera 308 and the newly identified anatomical landmark.

[0377] (The flowchart continues to follow the letter "D" to...) Figure 17b )

[0378] 7. Based on the results of the previously performed calculations, calculate the distance between the reference anatomical landmark and the newly identified anatomical landmark (1716).

[0379] 8. The measured distance between the reference anatomical landmark and the newly identified anatomical landmark is compared with a reference database (1718).

[0380] 9. Based on the comparison, assess whether the measured distance between the reference anatomical landmark and the newly identified anatomical landmark is below or above a predetermined threshold (1720).

[0381] 10. Provide diagnostic results based on the assessment (1722). In some embodiments, the diagnostic results are generated based on predetermined diagnostic results pre-stored in a database, corresponding to different possible measurement results of the various measurements required for the POP-Q assessment.

[0382] In some embodiments, the diagnostic results are sent to designated medical personnel for further evaluation and confirmation.

[0383] Exemplary assessment of pelvic prolapse using pressure sensors

[0384] In some embodiments, the internal pressure sensor is configured to be actuated during insertion of the elongated body (whether of fixed or variable length). In some embodiments, the system is configured to measure pressure and compare the sensed value to a predetermined baseline value. In some embodiments, if the system senses a value higher than a predetermined threshold, the system generates a preliminary diagnosis of pelvic prolapse. In some embodiments, the preliminary diagnosis is sent to a designated medical professional.

[0385] Exemplary methods for assessing urinary incontinence

[0386] In some embodiments, the system is configured to assess whether a user suffers from urinary incontinence.

[0387] Now for reference Figure 18 This diagram illustrates an exemplary location of a self-testing device 102 for assessing urinary incontinence according to some embodiments of the present invention. In some embodiments, the system is configured to instruct a user to insert the self-testing device 102 into a body cavity until a front-facing camera 308 visualizes the cervix in a first field of view (FOV1) of the front-facing camera 308, while one of one or more external cameras 310a-310b visualizes the urethra and / or anus in a second field of view (FOV2) of one of the one or more external cameras 310a-310b, and visualizes urine 1802 that may be discharged from the urethra. In some embodiments, both the cervix (internal) and the urethra (external) are visualized simultaneously.

[0388] Now for reference Figure 19 It shows a flowchart of an exemplary method for assessing urinary incontinence by means of the system according to some embodiments of the present invention. It illustrates a flowchart of a urinary incontinence assessment method performed by a system according to some embodiments of the present invention. In some embodiments, the urinary incontinence assessment method includes one or more of the following steps:

[0389] 1. Insert the elongated body into the human body cavity (1902).

[0390] 2. Assess the visualization of the cervix (1904).

[0391] 3. While maintaining visualization of the cervix, assess visualization of the urethra / anus (1906).

[0392] In some embodiments, the visualization order can be changed, i.e., the urethra is visualized first, and then the cervix is ​​visualized.

[0393] 4. Optionally, the patient is instructed to adopt a specific position (1908). In some embodiments, the position may be standing, sitting, squatting, supine, or lateral.

[0394] 5. Instruct users to perform exertion movements or physical exertion, such as coughing (1910).

[0395] 6. Acquire one or more images and / or videos (1912) from the front-facing camera 308, one or more external cameras 310a-310b, and an internal sensor 204 (e.g., a pressure sensor) disposed within the elongated body 306.

[0396] 7. Analyze the collected data (1914).

[0397] 8. Based on the analysis described above, assess whether one or more of the following conditions (1916) have occurred:

[0398] a. Abnormal displacement of the cervix;

[0399] b. The pressure sensor detected abnormal pressure;

[0400] c. Urine is detected being discharged from the urethra and / or feces are being discharged from the anus.

[0401] In some embodiments, the assessment results are sent to designated medical personnel for further processing.

[0402] Exemplary applications of systems for pelvic floor therapy

[0403] In some embodiments, the self-testing device 102 and one or more balloons 314 / 316 are used to provide pelvic floor therapy to the anterior and / or posterior vaginal cavity, and to provide feedback control based on pelvic floor muscle contraction and relaxation monitored by a front-facing camera and pressure sensors. In some embodiments, the one or more balloons also serve as a platform for applying pelvic floor therapy and providing feedback to the patient.

[0404] In this article, the term “about” refers to “within ±20%” when referring to quantities or values.

[0405] The terms “comprising,” “including,” “containing,” “having,” and their various variations all refer to “including but not limited to.”

[0406] The term "composed of" means "including but not limited to".

[0407] The term "consistently made up of" means that a composition, method, or structure may include additional ingredients, steps, and / or components, but only if the additional ingredients, steps, and / or components do not substantially alter the essential and novel characteristics of the claimed composition, method, or structure.

[0408] In this document, the singular forms “a,” “an,” and “the / said” include the plural forms unless the context explicitly defines them as singular. For example, the terms “a compound” or “at least one compound” can include multiple compounds, including mixtures thereof.

[0409] In this application, embodiments of the invention may be described in the form of a range. It should be understood that the range description is merely for convenience and brevity and should not be construed as a rigid limitation on the scope of the invention. Therefore, a description of a range should be considered as explicitly disclosing all possible sub-ranges within that range and the individual numerical values ​​within that range. For example, a description of a range such as "1 to 6" should be considered as specifically disclosing sub-ranges such as "1 to 3", "1 to 4", "1 to 5", "2 to 4", "2 to 6", "3 to 6", etc.; and the individual numbers within that range, such as 1, 2, 3, 4, 5, and 6. This is unrelated to the width of the range.

[0410] Whenever a range of values ​​is specified herein (e.g., “10-15”, “10 to 15”, or any pair of values ​​connected by these or other similar range notations), it should be understood to include any value (including decimals or integers) within the limits of that range, including the upper and lower limits of the range, unless the context clearly indicates otherwise. The terms “range / variation range / range” between the first and second indicated values, and “from…to,” “until,” “until,” or “through” (or other similar range indication terms) between the first and second indicated values, are used interchangeably herein and are intended to include the first and second indicated values ​​and all decimal and integer values ​​in between.

[0411] Unless otherwise stated, the numerical values ​​used herein and any ranges of numerical values ​​formed therefrom are approximate and are within the range of reasonable measurement and rounding errors as understood by those skilled in the art.

[0412] In this document, the term "method" refers to the manner, means, techniques and steps used to accomplish a given task, including but not limited to those known to those skilled in the art of chemistry, pharmacology, biology, biochemistry and medicine, or those manner, means, techniques and steps that can be readily developed by them based on known manner, means, techniques and steps.

[0413] It should be understood that certain features of the invention described separately in the context of different embodiments for clarity may also be provided in combination in a single embodiment. Conversely, various features of the invention described in the context of a single embodiment for simplicity may also be provided individually, or in any suitable sub-combination, or in an appropriate manner as in other embodiments of the invention. Features described in some embodiments that are not required to implement that embodiment should not be considered essential features of that embodiment.

[0414] The various embodiments and aspects of the invention described herein, as well as the content defined in the claims section below, can be supported by the following examples.

[0415] Examples of data provided to AI

[0416] Referring now to the following examples, which, in conjunction with the foregoing description, are used to illustrate some embodiments of the invention in a non-limiting manner.

[0417] In some embodiments, as described above, the system is configured to receive medical data, analyze it, and provide a preliminary diagnosis. In some embodiments, the system utilizes AI enhancement to learn and improve its diagnostic capabilities. In some embodiments, the system acquires multiple images, videos, and / or related medical data associated with healthy individuals to generate a database of predetermined attributes and attribute values ​​for healthy individuals, which serves as a reference for subsequent examinations (health reference). In some embodiments, the system acquires multiple images, videos, and / or related medical data associated with various diseases to generate a database of predetermined attributes and attribute values ​​for diseased individuals, which serves as a reference for subsequent examinations (illness reference).

[0418] Now for reference Figures 20a-20n The illustration shows exemplary visual data provided to AI according to some embodiments of the present invention.

[0419] Figure 20a An exemplary image of a healthy labia minora is shown.

[0420] Figure 20b An exemplary image of a vagina suffering from lichen sclerosus is shown.

[0421] Figure 20c An exemplary image of a patient with Paget's disease is shown.

[0422] Figure 20d An exemplary image of a patient with vulvar cancer is shown.

[0423] Figure 20e An exemplary image of a patient with cervical erosion is shown (top of the image and indicated by the arrow).

[0424] Figure 20f An exemplary image of a patient with vaginal canal rash caused by a drug reaction is shown.

[0425] Figure 20g An exemplary image of a patient suffering from vaginitis is shown.

[0426] Figure 20h An exemplary image of a patient suffering from atrophic vaginitis is shown.

[0427] Figure 20i An exemplary image of a patient suffering from a yeast / Candida infection is shown.

[0428] Figure 20j An exemplary image of a normal, healthy cervix is ​​shown.

[0429] Figure 20k Exemplary images of patients with cervical intraepithelial neoplasia (CIN) at different stages (stages 1-3) are shown.

[0430] Figure 20l An exemplary image of a normal, healthy posterior fornix is ​​shown.

[0431] Figure 20m An exemplary image of a normal, healthy anterior fornix is ​​shown (indicated by the arrow above).

[0432] Figure 20n An exemplary image of a patient suffering from rectal prolapse is shown.

[0433] Although the invention has been described in conjunction with specific embodiments thereof, it will be apparent to those skilled in the art that various substitutions, modifications, and variations can be made. Therefore, the invention is intended to cover all substitutions, modifications, and variations falling within the spirit and broad scope of the appended claims.

[0434] The applicant intends to incorporate all publications, patents, and patent applications mentioned herein by reference in their entirety, as if each individual publication, patent, or patent application had been expressly identified and incorporated herein by reference individually. Furthermore, any reference or identification of any reference in this application shall not be construed as an admission that such reference is prior art to the invention. Where section headings are used, they shall not be construed as limiting in any way. Additionally, any priority documents of this application are hereby incorporated herein by reference in their entirety.

Claims

1. A method for performing a medical examination via a self-testing device, the method comprising: a. Obtain one or more images and / or videos of one or more external anatomical landmarks and / or one or more internal anatomical landmarks; b. Analyze one or more images and / or videos acquired; include i. Based on the analysis, identify one or more attributes associated with the one or more external anatomical landmarks and / or the one or more internal anatomical landmarks; ii. Compare the identified attributes with the predefined attributes; iii. Identify the differences between the compared attributes based on predetermined attribute thresholds; c. Based on the identified differences between the attributes compared in the analysis, generate preliminary diagnostic results.

2. The method of claim 1, further comprising performing a calibration process; the calibration process comprising: a. Automatically identify one or more of the external anatomical landmarks; as well as b. Automatically identify one or more of the internal anatomical landmarks.

3. A method for performing a medical examination via a self-testing device, the method comprising: a. Position the self-testing device in front of the target organ; b. Acquire one or more images and / or videos of the external region of the target organ; c. Insert a portion of the self-testing device into the human cavity opening of the target organ; d. Acquire one or more images and / or videos of the internal region of the target organ; e. Analyze one or more images and / or videos acquired; including: i. Identify one or more external anatomical landmarks in the external region and identify one or more internal anatomical landmarks in the internal region; ii. Based on the analysis, identify one or more attributes associated with the one or more external anatomical landmarks and / or the one or more internal anatomical landmarks; iii. Compare the identified attributes with the predetermined attributes; iv. Identify the differences between the compared attributes based on predetermined attribute thresholds; f. Based on the identified differences between the attributes compared in the analysis, generate preliminary diagnostic results.

4. The method of claim 3, further comprising performing a calibration process; the calibration process comprising: a. Automatically identify one or more of the external anatomical landmarks; as well as b. Automatically identify one or more of the internal anatomical landmarks.

5. A method for automated quantitative medical examination of pelvic organ prolapse using a self-testing device, comprising: a. Establish the locations of reference anatomical landmarks; b. Insert a portion of the self-testing device into the body cavity opening; c. Generate a data acquisition timeline while performing the insertion; d. Acquire multiple data sets simultaneously with the insertion; e. Correlate the acquired data with the data acquisition timeline; f. Analyze the acquired data to identify anatomical landmarks; g. Calculate the distance between a predetermined position on the self-testing device and the identified mark; h. Based on the calculation results, calculate the distance between the reference anatomical landmark and the identified landmark; i. Compare the calculated distance between the reference anatomical landmark and the identified landmark with a distance value in a reference database; j. Based on the comparison, assess whether the calculated distance is lower or higher than a predetermined threshold; k. Generate diagnostic results based on the assessment.

6. The method according to claim 5, wherein, The acquisition of multiple data sets includes one or more of the following: a. Acquire multiple images and / or videos using the front-facing camera of the self-testing device; b. Acquire multiple images and / or videos using the one or more external cameras of the self-test device; as well as c. Acquire multiple sensor data from one or more sensors of the self-testing device.

7. The method according to claim 5, wherein, The reference anatomical landmark is the hymen.

8. The method according to claim 5, wherein, The acquisition includes acquiring one or more images and / or videos.

9. The method according to claim 5, wherein, The anatomical landmarks are one or more of the following: the midline of the anterior vaginal wall, the most distal portion of one side of the anterior vaginal wall, the lowest edge of the cervix, the highest point of the posterior vaginal wall, the midline of the posterior vaginal wall, the most distal portion of one side of the posterior vaginal wall, the urethral orifice, the midpoint of the posterior vaginal opening, and the anal opening.

10. The method according to claim 5, wherein, The predetermined position on the self-testing device is one or more of the following: the farthest end of the self-testing device, the position of the camera located at the farthest end of the self-testing device, or the position of one or more external cameras located on the self-testing device.

11. The method according to claim 5, wherein, The insertion includes retracting and actuating said portion of the self-testing device while keeping the rest of the self-testing device stationary.

12. A method for automatically assessing urinary incontinence in a patient using a self-testing device, the method comprising: a. Insert a portion of the self-testing device into the body cavity; b. Visualize the cervix within the aforementioned human body cavity; c. While maintaining visualization of the cervix, visualize the urethra; d. Instruct the patient to perform exertion movements and / or physical exertion; e. Acquire one or more medical data using the self-testing device while the patient is performing the exertion action and / or physical exertion; f. Analyze the acquired medical data; g. Based on the analysis, assess whether one or more of the following conditions have occurred: i. Abnormal displacement of the cervix; ii. The pressure sensor detected abnormal pressure; iii. Urine was detected flowing from the urethra.

13. The method of claim 12, further comprising instructing the patient to assume a specific position.

14. The method according to claim 12, wherein, The physical exertion described is coughing.

15. The method according to claim 12, wherein, The acquisition is performed through one or more of the following: a front-facing camera, one or more external cameras, and one or more sensors located inside the self-testing device.

16. The method according to claim 12, wherein, The medical data may be one or more of images, videos, physiological measurements, and stress measurements.

17. A device for performing medical self-examination, the device comprising: a. A slender body with a proximal end and a distal end; The distal end is configured to be inserted into the body cavity of the subject; b. A transparent protective cover disposed at the distal end of the elongated body; c. A base connected to the proximal end of the elongated body; the base includes at least one motor; d. One or more forward imaging devices disposed within the elongated body and configured to move along and within the elongated body by means of the motor; the one or more forward imaging devices having a field of view (FOV) through the transparent protective cover; the one or more forward imaging devices being configured to acquire one or more images and / or videos of the internal environment of the body cavity of the subject; e. A processor disposed within the base; the processor includes instructions for guiding the subject to complete a self-test process.

18. The apparatus of claim 17, further comprising one or more external imaging devices disposed on the base and facing the elongated body; the one or more external imaging devices being configured to acquire one or more images and / or videos of the external environment of the subject's body cavity opening.

19. The apparatus of claim 17 further includes a plurality of sensors.

20. The apparatus according to claim 19, wherein, The plurality of sensors are one or more of the following: vision sensor, ultrasonic sensor, temperature sensor, pressure sensor, humidity sensor, pH sensor, positioning sensor, position sensor, and force sensor.

21. The apparatus according to claim 19, wherein, The plurality of sensors are disposed on the outer surface of the elongated body; the plurality of sensors are configured to measure one or more sets of parameters of the internal environment of the human body cavity of the subject, the parameters including at least one of impedance, pH value and pressure.

22. The apparatus according to claim 19, wherein, The plurality of sensors includes at least one laser rangefinder sensor.

23. The apparatus according to claim 22, wherein, The at least one laser rangefinder sensor is positioned near the one or more forward imaging devices.

24. The apparatus of claim 17 further comprises one or more integrated light sources adjacent to the one or more forward imaging devices and / or the one or more external imaging devices.

25. The apparatus of claim 17, further comprising a graphical user interface (GUI) including one or more controls.

26. The apparatus of claim 17, further comprising a first inflatable member connected to the elongated body; the first inflatable member being an annular member surrounding the annular body.

27. The apparatus according to claim 26, wherein, The device includes controls configured to inflate and deflate the first inflatable member.

28. The apparatus according to claim 26, wherein, The first inflatable component is a single-piece structure or a multi-piece structure.

29. The apparatus according to claim 26, wherein, The first inflatable member is a single-weld structure or a multi-weld structure.

30. The apparatus according to claim 26, wherein, The first inflatable member includes a body, which is a uniform expansion structure or a non-uniform expansion structure.

31. The apparatus of claim 26, further comprising a second inflatable member, wherein the second inflatable member is connected to the first inflatable member and surrounds a portion of the first inflatable member at the distal end of the elongated body.

32. The apparatus according to claim 17, wherein, The elongated body is constructed to be a telescopic elongated body that can extend and retract.

33. The apparatus according to claim 17, wherein, The slender body is flexible.

34. The apparatus according to claim 33, wherein, The elongated body is configured to take the shape of the human body cavity and / or conform to the shape of the human body cavity.

35. The apparatus of claim 17, further comprising one or more of the following: a. At least one power source configured to provide power to the device; b. At least one pump connected to a first inflatable member and a second inflatable member; and c. A communication unit, the communication unit comprising at least one of a wireless communication interface and a non-wireless communication interface.

36. The apparatus according to claim 17, wherein, The processor further includes instructions for performing the method according to any one of claims 1, 3, 5 and / or 12.

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