WO2025099717A2

WO2025099717A2 - System and methods for gynecological examinations

Info

Publication number: WO2025099717A2
Application number: PCT/IL2024/051060
Authority: WO
Inventors: Einat Hila TZUR; Shlomo Bezalel COHEN-EYLON
Original assignee: Gynecheck Ltd
Current assignee: Gynecheck Ltd
Priority date: 2023-11-08
Filing date: 2024-11-05
Publication date: 2025-05-15
Anticipated expiration: 2026-05-08
Also published as: WO2025099717A3

Abstract

The invention relates to systems and methods for self-performing gynecological examinations. The system comprises a device for performing medical self-examinations, having an elongated body having a proximal end and a distal end; the distal end being configured to be inserted into a bodily orifice of a subject; one or more frontal imaging devices located at the distal end of the elongated body being configured to obtain one or more images and/or videos of an internal environment of the bodily orifice of the subject; and one or more external imaging devices located on a base and facing towards the elongated body being configured to obtain one or more images and/or videos of an external environment of the bodily orifice of the subject; and a processor comprising instructions for guiding the subject through a self-examination process.

Description

SYSTEM AND METHODS FOR GYNECOLOGICAL EXAMINATIONS

RELATED APPLICATION/S

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

FIELD AND BACKGROUND OF THE INVENTION

The present invention, in some embodiments thereof, relates to systems and methods for gynecological examinations and, more particularly, but not exclusively, to systems and methods for self-performing gynecological examinations.

Additional background art includes U.S. Patent No. 10,694,954 disclosing a system for imaging and diagnosing target internal tissues including an image acquisition system mechanically secured to a speculum.

U.S. Patent Application Publication No. 2019/0150725 disclosing speculum-free imaging systems for colposcopes and mammoscopes.

U.S. Patent Application Publication No. 2021/0338214 disclosing an endoscopic device for examination cum sample collection of an orifice of a user's body. In particular, the device is useful for vaginal and cervical examination. The device comprises a camera attached on the probe along with a radial luminous system and cytobrush for sample collection attached within the probe. A latex balloon and air flow directly through port are provided to inflate the vaginal cavity. The document also provides a method for sample collection and supervision through controlled camera.

U.S. Patent Application Publication No. 2021/ 0137357 disclosing a digital device for facilitating body cavity diagnosis. The device enables body cavity diagnosis with or without using a speculum. The device comprises a casing for enclosing a probe with additional channels. The additional channels comprise a plurality of instruments. The probe is configured for optical and digital diagnosis of abnormalities in body cavities. The probe is connected to wireless communication components for displaying captured images. The probe comprises an image capturing means for capturing images of abnormalities in a time sequenced manner, image processing means coupled to a computing device for digital image diagnosis and angulation wires for providing angulation control to the image capturing means. The casing has a transparent cap configured for visualizing structure of the cavity. The casing comprises an expandable outer cuff, for separating the walls of a body part. Chinese Patent Application No. 103948367 disclosing medical instruments and a vagina expander. The vagina expander comprises a handle, a control unit arranged in the handle and a pillar body connected with the handle; the pillar body is made of silica gel; an air bag is arranged at the front end of the pillar body; the air bag is made of ABS resin; a wrapping layer made of natural rubber is arranged at the outer surface of the air bag; a camera and a light source are arranged at the front end of the pillar body. The vagina expander is provided with the light source and more convenient to use, the light source adopts an LED (light emitting diode) lamp made of epoxy resin and very high in safety, and the medical safety is ensured; the air bag and the wrapping layer cannot scrap hairs and creases of parts such as the vagina, and an examined female cannot feel uncomfortable; the camera can be used for performing shooting, pattern collecting and the like on the internal condition of the vagina in an omnibearing mode, and the shot and collected patterns are transmitted to a computer, so a doctor and a nurse can repetitively examine the patterns.

U.S. Patent Application Publication No. 2021/ 0094167 disclosing a medical examining device including a sample tube detachably connectable to a viewing tool having a fiber optic viewing device. The sample tube defines a tube first end and an opposing tube second end and includes a tube wall extending between the tube first and second ends. The tube wall includes tube inner and outer surfaces extending between the tube first and second ends. The tube inner surface defines a central sampling channel sized and configured to longitudinally receive a sampling tool. A longitudinal channel extends partially through the tube wall from the tube first end towards the tube second end. A translucent lens is positioned in optical communication with the longitudinal channel adjacent the tube second end. The fiber optic viewing device is removably insertable within the longitudinal channel to dispose the fiber optic viewing device in optical communication with the translucent lens.

U.S. Patent Application Publication No. 2021/0033246 disclosing an endoscopic insertion aid including a tube member, a pipeline and a plurality of balloons. The tube member allows an insertion section of an endoscope to be inserted therethrough, and guides the longitudinal movement of the insertion section. The pipeline is provided in the tube member, and communicates with a supply/discharge unit to supply a fluid to or discharge the fluid from the distal end of the tube member. The balloons are disposed on the outer periphery of the distal end of the tube member longitudinally along the tube member, communicate with the pipeline, and inflate/deflate in accordance with the supply/discharge of the fluid via the pipeline. The balloon disposed on the distal side of the tube member is inflated to have an outside diameter larger than that of the balloon disposed closer to the proximal side than the balloon disposed on the distal side when the balloons are inflated. International Patent Application No. W02022005043A1 disclosing a disposable surfaceemitting tongue depressor, or a disposable examination tongue depressor enabling specimen selfcollection or an examination device therefor. It includes a condensing lens part which can receive, from an LED light source, light to be emitted in general and which can spotlight tonsil and pharynx parts, so as to minimize medical appliances used in an examination, and thus reduces pressure felt by a patient, and is discarded after one use to prevent concern about a secondary infection inside a clinic, and provides a specimen plate inserted into the nasopharynx to collect a body fluid, and thus conveniently collects the body fluid through the mouth, so that inconvenience and psychological pressure felt by the patient during a conventional oral examination and body fluid collection are alleviated and, simultaneously, the efficiency of examination and specimen collection is improved.

U.S. Patent Application Publication No. 2021/0085413 disclosing an anatomical- positioning apparatus for acquiring mechanical data from a tissue to facilitate determining type of the tissue and transition between different tissues and cavities. The anatomical-positioning apparatus includes a cannula, having a tip an expandable device having a contracted form size and an expanded form size, wherein the expanded form size is substantially larger than the contracted form size. The anatomical-positioning apparatus further includes an introducer, having a longitudinal axis and a distal end, facilitating the introduction of the expandable device into the tissue, the expandable device being in a contracted state, an expanding-mechanism for expanding and contracting the expandable device, and a sensor for measuring physical parameters associated with the expandable device. It is also disclosed a method for acquiring mechanical data from a tissue by an expandable device, while the expandable device exerts pressure onto portions of the tissue.

Chinese Patent No. 205083444 disclosing a palpation probe, include probe main part, probe handle and be located the pressure sensor matrix in the probe main part, it is inside that people's body cavity way is inserted to the probe main part, hardness, size, shape, the outward appearance of perception people body cavity way inner wall and perienchyma pathological change to on cable transmission to outside demonstration instrument, the device still is equipped with LED light source and camera, can in situ observation people's body cavity say through the camera to make inside pathological change position and outward appearance the device both can improve the chamber and say and the perienchyma pathological change, like the correct diagnosis rate of prostate cancer, the carcinoma of the rectum with diagnose the effect, unable in situ observation's technical problem in the time of can solving carcinoma of the rectum touch again.

U.S. Patent Application Publication No. 2021/0220594 disclosing an intubation stylet that includes a shaft with a bendable end section having a tip and a camera at the tip for providing an image of a part of the environment of the tip. The stylet includes a control unit for control of the bending motion of the end section. The control unit is adapted to work under at least two operation modes. In a first of the two operation modes the bending motion of the end section is guided automatically by an orientation of the tip. In a second operation mode, the bending motion of the end section is controlled by manual control of a user without an automatically guidance. The control unit is further adapted to operate in the second operation mode when the first operation mode is inactive.

SUMMARY OF THE INVENTION

Following is a non-exclusive list including some examples of embodiments of the invention. The invention also includes embodiments which include fewer than all the features in an example and embodiments using features from multiple examples, also if not expressly listed below.

Example 1. A method for performing a medical examination with a self-examination device, comprising: a. acquiring one or more images and/or videos of one or more external anatomical landmarks and/or one or more internal anatomical landmarks; b. analyzing said acquired one or more images and/or videos; c. generating a preliminary diagnosis based on said analysis.

Example 2. The method according to example 1, wherein said analyzing comprises: a. identifying one or more attributes related to said one or more external anatomical landmarks and/or said one or more internal anatomical landmarks based on said analysis; b. comparing said identified attributes with predetermined attributes; c. identifying a difference in said compared attributes according to a predetermined attribute threshold; wherein said generating said preliminary diagnosis is based on said identified differences in said compared attributes.

Example 3. The method according to example 1 or example 2, further comprising performing a calibration process; said calibration process comprising: a. automatically identifying said one or more external anatomical landmarks; and b. automatically identifying said one or more internal anatomical landmarks.

Example 4. A method for performing a medical examination with a self-examination device, comprising: a. positioning said self-examination device in front of an organ of interest; b. acquiring one or more images and/or videos of an external area of said organ of interest; c. inserting a part of said self-examination device within a bodily orifice of said organ of interest; d. acquiring one or more images and/or videos of an internal area of said organ of interest; e. analyzing said acquired one or more images and/or videos; f. generating a preliminary diagnosis based on said analysis.

Example 5. The method according to example 4, further comprising identifying one or more external anatomical landmarks in said external area and identifying one or more internal anatomical landmarks in said internal area.

Example 6. The method according to example 4 or example 5, wherein said analyzing comprises: a. identifying one or more attributes related to said one or more external anatomical landmarks and/or said one or more internal anatomical landmarks based on said analysis; b. comparing said identified attributes with predetermined attributes; c. identifying a difference in said compared attributes according to a predetermined attribute threshold; wherein said generating said preliminary diagnosis is based on said identified differences in said compared attributes.

Example 7. The method according to any one of the examples 4-6, further comprising performing a calibration process; said calibration process comprising: a. automatically identifying said one or more external anatomical landmarks; and b. automatically identifying said one or more internal anatomical landmarks.

Example 8. A method for performing an automated POP-Q medical examination with a selfexamination device, comprising: a. setting a location of a reference anatomical landmark; b. inserting a part of said self-examination device within a bodily orifice; c. generating a timeline of data collection while performing said inserting; d. acquiring a plurality of data collection while said inserting; e. associating said acquired plurality of data with said timeline of data collection; f. analyzing said acquired plurality of data for identifying anatomical landmarks; g. calculating a distance between a predetermined location on said self-examination device and said identified landmarks; h. calculating a distance between said reference anatomical landmark and said identified landmarks based on a result said calculating; i. comparing said calculated distances between said reference anatomical landmark and said identified landmarks with distances values in a reference database; j. evaluating, based on the comparison, if said calculated distances are below or above a predefined threshold; k. generating a diagnosis based on said evaluation.

Example 9. The method according to example 8, wherein said acquiring a plurality of data collection comprises one or more of: a. acquiring a plurality of images and/or videos with a front camera of said self-examination device; b. acquiring a plurality of images and/or videos with the one or more external cameras of said self-examination device; and c. acquiring a plurality of sensory data from one or more sensors of said self-examination device.

Example 10. The method according to example 8 or example 9, wherein said reference anatomical landmark is a hymen.

Example 11. The method according to any one of examples 8-10, wherein said acquiring comprises acquiring one or more images and/or videos.

Example 12. The method according to any one of examples 8-11, wherein said anatomical landmarks are one or more of a midline of anterior vaginal wall, a most distal portion of a side of said anterior vaginal wall, a lowest edge of a cervix, a topmost point of the posterior vaginal wall, a midline of posterior vaginal wall, a most distal portion of a side of said posterior vaginal wall, an urethral opening, a posterior vaginal opening and a mid-anal opening.

Example 13. The method according to any one of examples 8-12, wherein said predetermined location on said self-examination device is one or more of a most distal end of said self-examination device, a location of a camera located at a most distal end of said self-examination device, a location of one or more external cameras located on said self-examination device.

Example 14. The method according to any one of examples 8-13, wherein said inserting comprises telescopically actuating said part of said self-examination device while maintaining immobile a rest of said self-examination device.

Example 15. A method for performing an automated assessment of urinary incontinence in a patient with a self-examination device, comprising: a. inserting a part of said self-examination device within a bodily orifice; b. visualizing a cervix within said bodily orifice; c. visualizing a urethra while keeping said visualizing of said cervix; d. instructing said patient to perform an effort and/or a physical exertion; e. acquiring one or more medical data using said self-examination device while said patient performs said effort and/or a physical exertion; f. analyzing said acquired medical data; g. assessing, based on said analysis, whether one or more of the following occurred: i. an abnormal mobilization of the cervix occurred; ii. an abnormal pressure was sensed in the pressure sensors; iii. urine was detected exiting the urethra.

Example 16. The method according to example 15, further comprising instructing said patient to enter a specific stance.

Example 17. The method according to example 15 or example 16, wherein said physical exertion is coughing.

Example 18. The method according to any one of examples 15-17, wherein said acquiring is from one or more of a front camera, one or more external cameras and one or more sensors located inside said self-examination device.

Example 19. The method according to any one of examples 15-18, wherein said medical data are one or more of images, videos, physiological measurements and pressure measurements.

Example 20. A device for performing medical self-examinations, comprising: a. an elongated body having a proximal end and a distal end; said distal end being configured to be inserted into a bodily orifice of a subject; b. a base connected to said proximal end of said elongated body; c. one or more frontal imaging devices located at said distal end of said elongated body; said one or more frontal imaging devices being configured to obtain one or more images and/or videos of an internal environment of said bodily orifice of the subject; and d. one or more external imaging devices located on said base and facing towards said elongated body; said one or more external imaging devices being configured to obtain one or more images and/or videos of an external environment of said bodily orifice of the subject; e. a processor located within said base; said processor comprising instructions for guiding said subject through a self-examination process.

Example 21. The device according to example 20, further comprising a plurality of sensors.

Example 22. The device according to example 20 or example 21 , wherein said plurality of sensors are one or more of visual sensors, ultrasonic sensors, temperature sensors, pressure sensors, humidity sensors, pH sensors, location sensors, position sensors and force sensors. Example 23. The device according to any one of examples 20-22, wherein said plurality sensors are disposed on an exterior surface of said elongated body; said plurality sensors being configured for measuring one or more set of parameters of said internal environment of said bodily orifice of said subject comprising at least one of impedance, pH and pressure.

Example 24. The device according to any one of examples 20-23, further comprising one or more integrated light sources adjacent to said one or more frontal imaging devices and/or said one or more external imaging devices.

Example 25. The device according to any one of examples 20-24, further comprising a graphical interface unit (GUI), said GUI comprising one or more controls.

Example 26. The device according to any one of examples 20-25, further comprising a first inflatable member connected to said elongated body; said first inflatable member being an annular member surrounding the annular body.

Example 27. The device according to any one of examples 20-26, wherein said device comprises controls configured to inflate and deflate said first inflatable member.

Example 28. The device according to any one of examples 20-27, further comprising a second inflatable member, wherein said second inflatable member is connected to said first inflatable member and surrounds a portion of said first inflatable member at said distal end of said elongated body.

Example 29. The device according to any one of examples 20-28, wherein said elongated body is a telescopic elongated body configured for extending and retracting.

Example 30. The device according to any one of examples 20-29, wherein said elongated body is flexible.

Example 31. The device according to any one of examples 20-30, wherein said elongated body is configured for taking a shape and/or for following a shape of said bodily orifice.

Example 32. The device according to any one of examples 20-31 , further comprising one or more of: a. at least one power supply configured for providing power to said device; b. at least one pump connected to a first inflatable member and a second inflatable member; and c. a communication unit comprising at least one of a wireless and a non-wireless communication interface.

Example 33. The device according to any one of examples 20-32, wherein said processor comprises further instructions for performing any of the methods according to examples 1, 4, 8 and/or 15. 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 the invention pertains. Although methods and materials similar or equivalent to those described herein can be used in the practice or testing of embodiments of the invention, exemplary methods and/or materials are described below. In case of conflict, the patent specification, including definitions, will control. In addition, the materials, methods, and examples are illustrative only and are not intended to be necessarily limiting.

As will be appreciated by one skilled in the art, some embodiments of the present invention may be embodied as a system, method or computer program product. Accordingly, some embodiments of the present invention may take the form of an entirely hardware embodiment, an entirely software embodiment (including firmware, resident software, micro-code, etc.) or an embodiment combining software and hardware aspects that may all generally be referred to herein as a “circuit,” “module” or “system.” Furthermore, some embodiments of the present invention may take the form of a computer program product embodied in one or more computer readable medium(s) having computer readable program code embodied thereon. Implementation of the method and/or system of some embodiments of the invention can involve performing and/or completing selected tasks manually, automatically, or a combination thereof. Moreover, according to actual instrumentation and equipment of some embodiments of the method and/or system of the invention, several selected tasks could be implemented by hardware, by software or by firmware and/or by a combination thereof, e.g., using an operating system.

For example, hardware for performing selected tasks according to some embodiments of the invention could be implemented as a chip or a circuit. As software, selected tasks according to some embodiments of the invention could be implemented as a plurality of software instructions being executed by a computer using any suitable operating system. In an exemplary embodiment of the invention, one or more tasks according to some exemplary embodiments of method and/or system as described herein are performed by a data processor, such as a computing platform for executing a plurality of instructions. Optionally, the data processor includes a volatile memory for storing instructions and/or data and/or a non-volatile storage, for example, a magnetic hard-disk and/or removable media, for storing instructions and/or data. Optionally, a network connection is provided as well. A display and/or a user input device such as a keyboard or mouse are optionally provided as well.

Any combination of one or more computer readable medium(s) may be utilized for some embodiments of the invention. The 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, an electronic, magnetic, optical, electromagnetic, infrared, or semiconductor system, apparatus, or device, or any suitable combination of the foregoing. More specific examples (a non-exhaustive list) of the computer readable storage medium would include the following: an electrical connection having one or more wires, a portable computer diskette, a hard disk, a random access memory (RAM), a read-only memory (ROM), an erasable programmable read-only memory (EPROM or Flash memory), an optical fiber, a portable compact disc read-only memory (CD-ROM), an optical storage device, a magnetic storage device, or any suitable combination of the foregoing. In the context of this document, a computer readable storage medium may be any tangible medium that can contain, or store a program for use by or in connection with an instruction execution system, apparatus, or device.

A computer readable signal medium may include a propagated data signal with computer readable program code embodied therein, for example, in baseband or as part of a carrier wave. Such a propagated signal 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 that can communicate, propagate, or transport a program for use by or in connection with an instruction execution system, apparatus, or device.

Program code embodied on a computer readable medium and/or data used thereby may be transmitted using any appropriate medium, including but not limited to wireless, wireline, optical fiber cable, RF, etc., or any suitable combination of the foregoing.

Computer program code for carrying out operations for some embodiments of the present invention may be written in any combination of one or more programming languages, including an object oriented programming language such as Java, Smalltalk, C++ or the like and conventional procedural programming languages, such as the "C" programming language or similar programming languages. The program code may execute entirely on the user's computer, partly on the user's computer, as a stand-alone software package, partly on the user's computer and partly on a remote computer or entirely on the remote computer or server. In the latter scenario, the remote computer may be connected to the user's computer through any type of network, including a local area network (FAN) or a wide area network (WAN), or the connection may be made to an external computer (for example, through the Internet using an Internet Service Provider).

Some embodiments of the present invention may be described below with reference to flowchart illustrations and/or block diagrams of methods, apparatus (systems) and computer program products according to embodiments of the invention. It will be understood that each block of 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 may be provided to a processor of a general purpose computer, special purpose computer, or other programmable data processing apparatus to produce a machine, such that the instructions, which execute via the processor of the computer or other programmable data processing apparatus, create means for implementing the functions/acts specified in the flowchart and/or block diagram block or blocks.

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 devices to function in a particular manner, such that the instructions stored in the computer readable medium produce an article of manufacture including instructions which implement the function/act specified in the flowchart and/or block diagram block or blocks.

The computer program instructions may also be loaded onto a computer, other programmable data processing apparatus, or other devices to cause a series of operational steps to be performed on the computer, other programmable apparatus or other devices to produce a computer implemented process such that the instructions which execute on the computer or other programmable apparatus provide processes for implementing the functions/acts specified in the flowchart and/or block diagram block or blocks.

Some of the methods described herein are generally designed only for use by a computer, and may not be feasible or practical for performing purely manually, by a human expert. A human expert who wanted to manually perform similar tasks might be expected to use completely different methods, e.g., making use of expert knowledge and/or the pattern recognition capabilities of the human brain, which would be vastly more efficient than manually going through the steps of the methods described herein.

BRIEF DESCRIPTION OF THE DRAWINGS

Some embodiments of the invention are herein described, by way of example only, with reference to the accompanying drawings. With specific reference now to the drawings in detail, it is stressed that the particulars shown are by way of example and for purposes of illustrative discussion of embodiments of the invention. In this regard, the description taken with the drawings makes apparent to those skilled in the art how embodiments of the invention may be practiced.

In the drawings: Figure 1 is a schematic representation of an exemplary gynecological self-performed examination system, according to some embodiments of the invention;

Figure 2 is a schematic diagram showing exemplary units of an exemplary self-examination device for self-performing gynecological examinations, according to some embodiments of the invention;

Figures 3a-j are schematic representations of exemplary self-examination devices and features thereof, according to some embodiments of the invention;

Figures 4a-4q are schematic representations of exemplary embodiments of inflatable elements, according to some embodiments of the invention;

Figure 5 is a schematic representation of a cross section of an exemplary self-examination device, according to some embodiments of the invention;

Figures 6a-c are schematic representations of exemplary means and method for assessing distances during the procedures, according to some embodiments of the invention;

Figure 7a is a schematic representation of an external view of the vaginal area;

Figure 7b is a schematic representation from a point of view of an upper external camera of the self-examination device of external anatomical landmarks, according to some embodiments of the invention;

Figure 7c is a schematic representation from a point of view of a lower external camera of the self-examination device of external anatomical landmarks, according to some embodiments of the invention;

Figures 8a-d are flowcharts of an exemplary method of external calibration from the point of view of the system, according to some embodiments of the invention;

Figure 9 is a flowchart of an exemplary method of external calibration from the point of view of the user, according to some embodiments of the invention;

Figures lOa-b are schematic representations of the elongated body of the self-examination device being inserted within the bodily orifice, according to some embodiments of the invention;

Figure 10c is a schematic representation of the visualization of the internal environment of the bodily orifice by the self-examination device, according to some embodiments of the invention;

Figure 11 is a flowchart of an exemplary method of performing external and/or internal self-examinations, according to some embodiments of the invention;

Figure 12 is a schematic representation of the POP-Q system locations;

Figure 13a-c are schematic representations of the POP-Q system locations and exemplary measurements, according to some embodiments of the invention; Figure 14 is a schematic representation of an exemplary self-examination device 102 for the use of performing measurements, according to some embodiments of the invention

Figures 15a-b are flowcharts of an exemplary method of performing a POP-Q assessment by the system, according to some embodiments of the invention;

Figure 16 is a schematic representation of an exemplary self-examination device for the use of performing measurements, according to some embodiments of the invention;

Figures 17a-b are flowcharts of an exemplary method of performing a POP-Q assessment by the system, according to some embodiments of the invention;

Figure 18 is a schematic representation of an exemplary position of the self-examination device for assessing urinary incontinence, according to some embodiments of the invention;

Figure 19 is a flowchart of an exemplary method of assessing urinary incontinence by the system, according to some embodiments of the invention;

Figures 20a-n are exemplary visual data provided to the Al, according to some embodiments of the invention.

DESCRIPTION OF SPECIFIC EMBODIMENTS OF THE INVENTION

Overview

An aspect of some embodiments of the invention relates to self-performed gynecological medical examinations. In some embodiments, the examinations are performed using a dedicated device configured for guiding a non-professional user over one or more steps of the medical examination. In some embodiments, the medical examination comprises the collection of one or more of at least one picture, at least one video, at least one ultrasound, 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 automatically analyzed to provide medical insights to a medical professional and/or a user. In some embodiments, analyzed medical data is used for diagnosing a patient. In some embodiments, the diagnosing is automatic. In some embodiments, medical data collected during the examination is used to generate a personalized medical profile of the patient. In some embodiments, medical data collected during the examination is used to update an existing personalized medical profile of the patient. In some embodiments, medical data collected during the examination is compared with a personalized baseline and/or compared with data from a database. In some embodiments, the dedicated device comprises an internal camera provided with a distance regulation mechanism that allows for an automated and/or manual repositioning of the internal camera to provide one or more of: an improved focus; an improved picture quality, for example in the case of dirt and moisture on the probe front cap; and an adjusted field of view to see more or less from the side walls. In some embodiments, the dedicated device comprises one or more inflatable bodies configured to expand the walls of the area being examined. In some embodiments, the inflatable bodies are configured to expand isometrically and/or non- isometrically. In some embodiments, the dedicated device comprises one or more sensors configured to assist in the examination process.

Before explaining at least one embodiment of the invention in detail, it is to be understood that the invention is not necessarily limited in its application to the details of construction and the arrangement of the components and/or methods set forth in the following description and/or illustrated in the drawings and/or the Examples. The invention is capable of other embodiments or of being practiced or carried out in various ways.

Referring now to Figure 1, showing a schematic representation of an exemplary gynecological self-performed examination system, according to some embodiments of the invention. In some embodiments, an exemplary gynecological self-performed examination system 100 comprises a dedicated device 102 for self-performing gynecological examinations (referred hereinafter just as “self-examination device 102”) configured to be used, for example, by a non- medical-trained user, and further configured to collect one or more medical data (see below further explanations about the self-examination device 102). In some embodiments, the dedicated device 102 is connected to one or more servers 104 (referred hereinafter just as “server”). In some embodiments, medical data collected by the self-examination device 102 is sent to the server 104. In some embodiments, the server 104 comprises instructions to analyze the medical data received by the self-examination device 102. In some embodiments, the server comprises one or more databases configured to store a plurality of data, used for example for a plurality of purposes like comparison, validations, verification, authentication and deep analysis of data. In some embodiments, medical data is sent to a medical professional 106, for example a physician, a nurse or any other specialized personnel having permissions to receive medical data (for example, insurance companies). In some embodiments, the self-examination device 102 comprises the minimal software and hardware to perform analysis on the medical data (see below). In some embodiments, the medical data is sent to the medical professional 106 in real-time, meaning, the medical data is sent while the user is performing the collection of the medical data with the self- examination device 102. In some embodiments, the medical professional 106 can receive the data at a later time by either accessing the medical data stored at the server 104 or directly accessing the stored data in the self-examination device 102. In some embodiments, the system is configured to store and/or provide raw medical data and/or analyzed medical data. In some embodiments, as will be further explained below, the self-examination device 102 comprises a part (elongated body) that is inserted within a bodily orifice of the subject while another part of the device is used to collect data of areas externally of the bodily orifice of the subject.

Exemplary self-examination device 102

Referring now to Figure 2, showing a schematic diagram showing exemplary units of an exemplary self-examination device 102 for self-performing gynecological examinations, according to some embodiments of the invention. In some embodiments, an exemplary self-examination device 102 comprises an external case 202 configured to encase one or more electronic components. In some embodiments, the self-examination device 102 comprises one or more sensors 204. In some embodiments, the one or more sensors are more than one type of sensor. In some embodiments, the one or more sensors are a plurality of a same type of sensor. In some embodiments, the one or more sensors are a plurality of types of sensors where there are a plurality of sensors of each type. In some embodiments, the self-examination device 102 comprises one or more controllers 206 (one shown in Figure 2 - and referred hereinafter just as “controller”). In some embodiments, the controller 206 comprises instructions to perform one or more of (not a complete list) activate the one or more sensors 204, provide instructions to a user, receive sensor data from the one or more sensors 204 and receive/send data. In some embodiments, the selfexamination device 102 comprises one or more memory modules 208. In some embodiments, the self-examination device 102 comprises one or more communication units 210 configured to communicate, for example, with the server 104, with the medical professional 106 and/or with an external electronic device (for example a mobile phone and/or tablet). In some embodiments, the self-examination device 102 comprises one or more graphic interface units 212 (GIU), configured for allowing input/out communication between the self-examination device 102 and the user. In some embodiments, the GUI 212 is an integral part of the self-examination device 102. In some embodiments, the GUI 212 is separated from the self-examination device 102 and communications between the device and the user are transmitted through wires and/or wirelessly. In some embodiments, the self-examination device 102 comprises one or more power sources 214 configured to provide the necessary power to the different parts of the self-examination device 102. In some embodiments, the power is provided by a battery, optionally a rechargeable battery. In some embodiments, power is provided by a cable connected to the self-examination device 102. In some embodiments, the self-examination device 102 comprises one or more pumps 214 configured for inflating one or more balloons (see below).

Referring now to Figure 3 a, showing a schematic representation of an exemplary selfexamination device 102, according to some embodiments of the invention. In some embodiments, an exemplary self-examination device 102 comprises a handle 302 located at a proximal end of the self-examination device 102. In some embodiments, an exemplary self-examination device 102 comprises a main body 304, configured to house the plurality of components as shown for example in Figure 2. In some embodiments, the handle 302 is connected to the main body 304. In some embodiments, optionally, the handle 302 is also configured for housing at least part of the electrical components. In some embodiments, the handle 302 and the main body 304 are one and the same. In some embodiments, an exemplary self-examination device 102 comprises an elongated body 306 extending distally from the main body 304 and configured to be inserted within a bodily orifice of the subject. In some embodiments, the elongated body 306 is configured to house at least part of the electronic components (see below). In some embodiments, the elongated body 306 is flexible, as schematically shown for example in Figure 3b and/or may comprise internal compartments that allow certain levels of bending to the elongated body 306. In some embodiments, the elongated body 306 is flexible enough to take the shape and/or follow the shape of the place where the elongated body 306 is being inserted. In some embodiments, the elongated body 306 is rigid and the place where the elongated body 306 is inserted adapts to the shape of the elongated body 306. In some embodiments, optionally, the elongated body 306 is a telescopic elongated body 306 configured to extend and retract according to the needs (see below), as shown for example in Figure 3c. In some embodiments, the elongated body 306 comprises a length of from about 8cm to about 10cm (in its most extended position when comprising a telescopic mechanism); optionally from about 6cm to about 12cm; optionally form about 4cm to about 15cm.

Exemplary sensors

In some embodiments, as mentioned above, an exemplary self-examination device 102 comprises one or more sensors. In some embodiments, exemplary sensors are one or more of visual sensors (e.g. one or more cameras), ultrasonic sensors, temperature sensors, pressure sensors, humidity sensors, pH sensors, location sensor (e.g. gyroscope, GPS, etc.), “electronic-nose” sensor, MRI sensors and force sensors. In some embodiments, the one or more cameras comprise one or more mechanisms configured to change the field of view, direction and/or focus of the camera without the need to change the direction of the self-examination device 102 itself. In some embodiments, the change of the field of view and/or direction and/or focus of the camera is done by moving the camera.

In some embodiments, the self-examination device 102 comprises ultrasound hardware and/or MRI hardware, which together with the dedicated guidance system, are configured to allow an untrained user to perform discrete ultrasonic examinations.

Referring now to Figure 3d, showing a schematic representation of an exemplary selfexamination device 102 with a plurality of sensors, according to some embodiments of the invention. In some embodiments, the self-examination device 102 comprises a frontal camera 308, optionally comprising one or more light sources (not shown). In some embodiments, the frontal camera is protected by a transparent dome 318 positioned at the most distal end of the elongated body 306. In some embodiments, part of the elongated body 306 adjacent to the dome 318 is also transparent. In some embodiments, the frontal camera 308 is configured to obtain images and/or videos of the internal environment of the bodily orifice of the subject, which may include a cervix view, a posterior fornix view, and an anterior fornix view and a vagina panoramic view. In some embodiments, the frontal camera 318 is in a fixed position at the most distal end of the elongated body 308 (behind the dome 318).

In some embodiments, the self-examination device 102 optionally comprises one or more external cameras 310a-b, each optionally comprising one or more light sources (not shown). In Figure 3d two external cameras 310a and 310b are shown, both facing forward in the same direction of extension of the elongated body 306, one (310a) positioned on an upper part of the main body 304 and another (310b) positioned on a bottom part of the main body 304. In some embodiments, the one or more external cameras are configured for obtaining images and/or videos of external anatomical features, which may include a panoramic pelvic view and a vulvar- vestibular panoramic view. In some embodiments, the self-examination device 102 comprises a single external camera.

In some embodiments, the self-examination device 102 comprises one or more sensors 312 located within the elongated body 306, for example, temperature sensors, pressure sensors, humidity sensors, pH sensors and force sensors. In some embodiments, the one or more sensors 312 are configured to collect medical data from within the internal environment of the bodily orifice of the subject. Referring now to Figure 3e, showing another schematic representation of an exemplary self-examination device 102 with a plurality of sensors, according to some embodiments of the invention. Figure 3e shows a zoom-in of the distal end of the elongated body 306 and internal mechanism positioned within the elongated body 306. In some embodiments, as mentioned above, the self-examination device 102 comprises a frontal camera 308. In some embodiments, the frontal camera 308 is positioned within the elongated body 306. In some embodiments, the transparent dome 316 at the distal end of the elongated body 306 (and optionally a transparent part of the most distal part of the elongated body 306) is configured to provide the necessary potential field of view to the frontal camera 308 positioned within the elongated body 306. In some embodiments, the frontal camera 308 is connected to a lateral movement mechanism 320, positioned either at the handle 302, or at the main body 304, or within the elongated body 306. In Figure 3e, the lateral movement mechanism 320 is shown at the main body 304. In some embodiments, the frontal camera 308 is configured to be brought forward until meeting the transparent dome 318. In some embodiments, the frontal camera 308 is configured to be brought backwards, in relation to the transparent dome 318, as distance of from 0.01mm to 1cm. Optionally from 0.005 to about 2cm. Optionally from 0.001 to about 3cm.

In some embodiments, the motorized frontal camera 308 is configured to provide one or more of the following potential advantages: improved focus, improved picture quality in the case of dirt and/or moisture on the transparent dome 318 (items that are not in focus do not interfere with the picture quality of the cervix), adjusted field of view (FOV) to see more or less from the side walls, for example a wider or narrower FOV.

In some embodiments, providing a motorized frontal camera 308 potentially allows to compensate for the uncertainty of the self-examination device 102 final positioning (for example, distance from the Cervix). In some embodiments, by moving the camera the FOV can be changed (the closer to the cervix, the smaller the field of view and vice versa), without the need to move the self-examination device 102 itself. In some embodiments, as mentioned above, moving the camera allows to adjust the focusing of the camera (instead of moving just lens).

In some embodiments, the motorized frontal camera 308 is configured to move backwards to allow visualization of the vagina walls. In some embodiments, the movement of the motorized frontal camera 308 is used to play/adjust for the effect of the lightning (incorporated within the device), and/or optimizing for reflections.

In some embodiments, the motorized frontal camera 308 is controlled manually and/or automatically with smart control logic, by the user and/or remotely by the physician. In some embodiments, another potential advantages of the frontal camera 308 is that the axis of movement of the motorized frontal camera 308 allows adjustment of both focus and visual acuity along the road from the outer surface of the vulvar and perineum through all the 5-step calibration method (explained herein elsewhere). In some embodiments, another potential advantages of the frontal camera 308 is that the freedom of movement for the frontal camera 308 allows maximal usage of one camera, in case there is only one camera, that may provide all data without adding more cameras that will increase the outer diameter of the device and decrease the visual acuity, another potential advantages of the frontal camera 308 is that an independent camera that is configured to rotate 360 degrees is capable to provide all the required data without the need to combine photos or videos from several cameras to achieve the same results.

Exemplary inflation mechanism

Referring now to Figures 3f-3j, showing schematic representation of exemplary inflation mechanism of an exemplary self-examination device 102, according to some embodiments of the invention. In some embodiments, at the distal end of the elongated body 306, there is an inflatable element 314, for example a balloon, configured to be inflated within the internal environment of the bodily orifice of the subject. In Figure 3f, the inflatable element 314 is shown in a deflated configuration, while in Figure 3g, the inflatable element 314 is shown in an inflated configuration. In some embodiments, the inflatable element is used to separate the walls of the bodily orifice in order to allow the front camera 308 to better visualize the internal environment of the bodily orifice; and/or to provide anchoring means and stabilization to the self-examination device 102. Referring now to Figures 3h-3i, in some embodiments, there is an additional second inflatable element 316 located at the most distal end of the elongated body 306 and, optionally, on top of the inflatable element 314 and configured to further extend beyond the first inflatable element 314. In some embodiments, the second inflatable element 316 is used to further separate the walls of the bodily orifice and also for further anchoring and stabilization of the self-examination device 102.

Exemplary automated/semi-automated actuation of balloons

In some embodiments, during the operation of the device, the one or more balloons are automatically operated to allow the cameras to visualize the internal anatomical landmarks (see below). In some embodiments, the system comprises dedicated instructions, optionally under the guidance of a dedicated Al software, to screen and search for the anatomical landmarks according to an estimated location and actuate accordingly the one or more balloons in order to achieve results. In some embodiments, the system is semi-automatic, which means that the system provide instructions to the user to either inflate or deflate the balloons. In some embodiments, a potential advantage of utilizing a semi-automatic system is that it potentially provides a safety mechanism against causing pain and/or discomfort to the user by the inflation of the one or more balloons. In some embodiments, the one or more balloons are compartmentalized balloons and each compartment can be inflated/deflated independently to the others. In some embodiments, a potential advantage of having compartmentalized balloons is that is allows the system to mobilize relevant tissues where necessary in order to positively visualize the internal anatomical landmarks.

Figure 3j shows a schematic representation of an exemplary self-examination device 102, comprising all the features as described above, namely, a handle 302, a main body 304 with two external cameras 310a-b, an elongated body 306, with internal sensors 312, two inflatable elements 314/316 and a frontal camera 308.

Exemplary embodiments of inflatable elements

Referring now to Figures 4a-4q, showing exemplary embodiments of inflatable elements, according to some embodiments of the invention.

In some embodiments, the main role of the inflatable elements is to provide physical separation of the tissues in order to allow for the camera (for example the frontal camera) to have a field of view of the cervix and so allowing to perform the visual examination.

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

Type of inflatable element

In some embodiments, the inflatable element is made of a single inflatable body (referred hereinafter as mono-body) or is made of a plurality of inflatable bodies (referred hereinafter as multi-body).

Type of welding

In some embodiments, the inflatable element comprises either a single weld (referred hereinafter as single-weld) or comprises two or more welds (referred hereinafter as multi-weld).

Geometry

In some embodiments, the inflatable element either comprises an isometric geometry, which means that the inflatable element inflates the same in all parts, or comprises a non-isometric geometry, which means that the inflatable member inflates differently in one or more parts in relation to other parts in the same inflatable member. In some embodiments, non-isometric geometries allow to provide more separation in one side of the inflatable element when compared to other sides in the same inflatable element (see below).

In the following paragraphs several possible embodiments of inflatable elements will be explained, each having a particular set of features from the abovementioned features. It should be understood that the following are exemplary embodiments provided to allow a person having skills in the art to understand the invention, and are not meant to be limiting in any way.

Referring now to Figures 4a-4e showing schematic representation of multi- weld inflatable elements, according to some embodiments of the invention.

Figure 4a shows a mono-body multi-weld isometric inflatable element 402. In some embodiments, the inflatable element 402 comprises a single inflatable body 404 and two welds 406/408, positioned eccentrically and concentrically respectively, the body 404 having an isometric geometry.

Figure 4b shows a mono-body multi-weld non-isometric inflatable element 410. In some embodiments, the inflatable element 410 comprises a single inflatable body 412 and two welds 406/408, positioned eccentrically and concentrically respectively, the body 412 having a nonisometric geometry.

It can be seen that the non-isometric single inflatable body 412 comprises an area A that, when inflated, is smaller in size than area B, which provides the non-isometric geometry to the body 412.

Referring now to Figures 4c-4e, schematically showing an exemplary inflatable element 402 mounted on an elongated body, according to some embodiments of the invention. In some embodiments, as explained above, inflatable elements are mounted on the distal end of the elongated body 306. Figure 4c, shows the exemplary mono-body multi-weld isometric inflatable element 402 in a deflated configuration. Figure 4d, shows the exemplary mono-body multi-weld isometric inflatable element 402 in an inflated configuration. In some embodiments, a characteristic of multi- weld inflatable elements is that the inflatable element is connected to the elongated body 306 at a single point - for example at the concentric weld 408, as schematically shown by circles 414 in Figure 4e.

Referring now to Figures 4f-4k showing schematic representation of single-weld inflatable elements, according to some embodiments of the invention. Figures 4f-4g show a mono-body single-weld isometric inflatable element 416. In some embodiments, the inflatable element 416 comprises a single inflatable body 404 (similar to that shown in Figure 4a) and one weld 406, positioned eccentrically, the body 404 having an isometric geometry. Figure 4f shows a semi-transparent view of the body 404 to allow showing the two connecting areas 418/420 located concentrically in the body 404.

Figures 4h-4i show a mono-body single- weld non-isometric inflatable element 422. In some embodiments, the inflatable element 422 comprises a single inflatable body 412 (similar to that shown in Figure 4b) and one weld 406, positioned eccentrically, the body 412 having a nonisometric geometry.

Figure 4h shows a semi-transparent view of the body 412 to allow showing the two connecting areas 418/420 located concentrically in the body 412.

Referring now to Figures 4j-4k, schematically showing an exemplary inflatable element 416 mounted on an elongated body, according to some embodiments of the invention. In some embodiments, as explained above, inflatable elements are mounted on the distal end of the elongated body 306. Figure 4j, shows the exemplary mono-body single-weld isometric inflatable element 416 in an inflated configuration. In some embodiments, a characteristic of single-weld inflatable elements is that the inflatable element is connected to the elongated body 306 at two points - for example at the two connecting areas 418/420, as schematically shown by circles 424/426 in Figure 4k.

Referring now to Figures 41-4o showing schematic representation of multi-body inflatable elements, according to some embodiments of the invention.

Figure 41 shows a multi-body inflatable isometric element 428. In some embodiments, the inflatable element 428 comprises a multiple inflatable bodies 430a-f optionally interconnected by one or more inflation channels 432a-c configured to allow inflation of all inflatable bodies 430a-f at a same time; the inflatable element 428 having an isometric geometry. In some embodiments, optionally, the inflatable bodies 430a-f are held together by a band 434 configured for increasing the pushing area of the inflatable element 428 once inflated.

Figure 4m shows a multi-body non-isometric inflatable element 436. In some embodiments, the inflatable element 436 comprises a multiple inflatable bodies 430a-f optionally interconnected by one or more inflation channels 432a-c configured to allow inflation of all inflatable bodies 430a- f at a same time; the inflatable element 428 having a non-isometric geometry by providing one or more inflatable bodies with a different size. In Figure 4m, two inflatable bodies 430a/430b are bigger in size than the others. In some embodiments, optionally, the inflatable bodies 430a-f are held together by a band 434 configured for increasing the pushing area of the inflatable element 436 once inflated.

It can be seen that the non-isometric multi-body inflatable element 436 comprises two areas A/A’ that, when inflated, is smaller in size than area B, which provides the non-isometric geometry to the body 412.

Referring now to Figures 4n-4o, schematically showing an exemplary inflatable element 436 mounted on an elongated body, according to some embodiments of the invention. In some embodiments, as explained above, inflatable elements are mounted on the distal end of the elongated body 306. Figure 4n, shows a top view of the exemplary multi-body isometric inflatable element 436 in an inflated configuration. Figure 4o, shows a bottom view of the exemplary multibody isometric inflatable element 436 in an inflated configuration.

Referring now to Figures 4p-4q, showing schematic representations of an exemplary inflatable element, according to some embodiments of the invention. In some embodiments, an inflatable element 438 is an inflatable sleeve mounted on the elongated body. Figure 4p shows a schematic representation of the inflatable sleeve element 438 in an inflated configuration, while Figure 4q shows a schematic representation of the inflatable sleeve element 438 in an inflated configuration mounted on the elongated body 306.

Exemplary overview of an exemplary self-examination device

Referring now to Figure 5, showing a cross section of an exemplary self-examination device, according to some embodiments of the invention. Same parts were provided with the same reference numbers as in previous Figures. The exemplary self-examination device 500 comprises a handle 302 and an elongated body 306. At the most distal end of the elongated body 306 there is a transparent protective dome 318. The exemplary self-examination device 500 comprises an internal frontal camera 308 configured to move within the elongated body 306 using a movable stand 502 connected to a dedicated motor 504. Figure 5 shows the wires 506 of the internal frontal camera 308 extending proximally towards the handle 302. The exemplary self-examination device 500 comprises an inflatable element 416, in this example the inflatable element 416 is a monobody single-weld isometric inflatable element 416. The exemplary self-examination device 500 comprises electronic modules (generally shown as 506) and a battery 508. It should be understood that the example shown in Figure 5 is just a non-limiting example, and that parts can be changed with either embodiment explained herein, for example a different inflatable element, an extendable elongated body, one or more external cameras and a plurality of sensors.

Exemplary means and methods for assessing distances

Referring now to Figures 6a-6c, showing schematic representation of exemplary means and method for assessing distances during the procedures, according to some embodiments of the invention.

In some embodiments, distances are measured and monitored using a laser sensor, for example a using a laser diode (for example as small as 0.5mm) and a lens that focuses the laser to get a collimated beam.

Referring now to Figures 6a-6b, showing schematic representations of laser triangulations, according to some embodiments of the invention. In Figures 6a-6b, it is seen a partial view of the elongated body 306, the internal frontal camera 308 and the transparent protective dome 318. Additionally, it can be seen a laser 602 and dedicated lens 604. The device is positioned in front the cervix 606 at a certain distance (in Figure 6a the distance is greater than in Figure 6b). Schematically shown are the field of view (FOV) 608 of the camera and the laser beam trajectory 610. In some embodiments, if the device is too far from the target (cervix 606), the laser dot 612 will be seen by the camera in a position not in the center, for example as shown in Figure 6a, in a location upper of the center of the FOV. In this example, viewing the laser dot 612 in that location means that the device is still far from the target. In some embodiments, when the laser dot 612 is seen at the center of the FOV, for example as shown in Figure 6b, this means that the device has reached the desired distance from the target.

In some embodiments, the distance is calculated by calculating the angle of projection of the laser and the known location of the camera. Using these two parameters, the distance D is calculated, so when the laser dot 612 is seen at the center of the FOV, this means that the device is at a distance D from the target.

Referring now to Figure 6c, showing a variation of the embodiment of the distance measurement using lasers, according to some embodiments of the invention. In some embodiments, when using one laser, the user and/or the system (automatically) detects the correct distance by moving the device until the laser spot is brought to the center of the FOV.

In some embodiments, multiple lasers positioned around the frontal camera 308 can be used. In some embodiments, when using multiple lasers, the user and/or the system (automatically) detects the correct distance by moving the device until all the laser spots are brought to the center of the FOV. In some embodiments, these methods can be used to measure the actual absolute distance and/or it can be used to detect if the device is in the correct distance or not. In some embodiments, using one laser and replacing the lens with a diffuser (that spreads the laser to many dots on the entire surface of the cervix, speckles), the software can detect the distance by analyzing the spread of the speckles.

In some embodiments, the laser is turned ON automatically every X seconds (for example every 0.5 seconds, 1 second, 2 seconds) to check the distance to the target. In some embodiments, the laser can be turned on for a very short time relative to the camera frame rate, so it is negligible for the user when looking at the video. In some embodiments, another option is to keep the laser ON until reaching the proper distance and then turn it off to improve image quality.

Exemplary GUI

In some embodiments, an exemplary GUI comprises one or more control buttons that allow a user to activate the self-examination device 102 and performs actuation of commands, for example, inflating/deflating the inflatable elements, extending/retracting the elongated body 306, activate/deactivate either sensor and/or cameras. In some embodiments, the GUI may comprise a digital screen, where visual cues are provided to the user. In some embodiments, the GUI does not comprise a digital screen and the GUI is just a User Interface (UI). In some embodiments, the GUI may comprise speakers configured to provide verbal instructions (see below) and/or indication sounds (like beeps). In some embodiments, the GUI may comprise one or more visual lights configured to provide dedicated signaling to the user regarding a specific actuation of the selfexamination device 102. In some embodiments, the GUI is provided as an App for an electronic device, like a cellphone, a tablet or a dedicated electronic device provided as part of the selfexamination device 102.

Exemplary methods

Exemplary guidance system

In some embodiments, the self-examination device 102 comprises a dedicated software configured to guide the user during the self-examination procedure, including the calibration process and/or the self-examination process itself. In some embodiments, the guiding comprises one or more of verbal guiding (for example instructions being provided via the one or more speakers), imaging guiding (for example using a video shown in the GUI) and visual guiding (for example using lights that indicate either success or failure if a certain action). Exemplary calibration method

In some embodiments, when using the self-examination device 102, the system optionally requires a calibration of the anatomical landmarks of the user before beginning the collection of medical data. Referring now to Figure 7a schematically showing an external view of the vaginal area. In some embodiments, anatomical landmarks are one or more of the pubic area, the clitoral hood, the clitoris, the labium mayora, the labium minora, the urethra, the hymen, the vaginal canal, the perineum and the anus.

Referring now to Figure 7b, showing a schematic representation from a point of view of an upper external camera 310a of the self-examination device 102 of external anatomical landmarks, according to some embodiments of the invention; and to Figure 7c, showing a schematic representation from a point of view of a lower external camera 310b of the self-examination device 102 of external anatomical landmarks, according to some embodiments of the invention. In some embodiments, the external cameras are configured to have in their field of view the extending elongated body 306.

In some embodiments, when there is only one external camera, the user is guided to rotate the device about 180 degrees to position the external camera one time on an upper part of the device, and another time on the bottom part of the device.

In some embodiments, an exemplary method of calibration comprises an automatic identification of the external anatomical landmarks. In some embodiments, an exemplary selfperformed examination system 100 utilizes automated identification software, optionally enhanced with artificial intelligence (Al) capabilities, to perform the calibration process (see below exemplary automated identification process using Al).

In some embodiments, an exemplary method of calibration comprises a guided identification of the external anatomical landmarks. In some embodiments, once the cameras are being actuated, the system is configured to ask the user to identify one or more external anatomical landmarks, for example by either requesting the user to point out, for example with a finger, a certain anatomical landmark; or for example by requesting the user to approve an automatic identified external anatomical landmark, which has been identified by the system. For example, the system automatically identifies the clitoris. Then, the system shows the identified clitoris to the user via the GUI and requests confirmation that the identified object is indeed the clitoris. In some embodiments, the system is configured to provide alternative external anatomical landmarks in case the automatic identification was not correct.

Referring now to Figures 8a-8d, showing a flowchart of an exemplary method of external calibration from the point of view of the system, according to some embodiments of the invention. In some embodiments, an exemplary method of performing external calibration comprises one or more of the following actions:

In some embodiments, the system requests from the user to position the self-examination device 102 in front of the vaginal area (802).

In some embodiments, the system receives confirmation from the user that the selfexamination device 102 is in front of the vaginal area (804).

In some embodiments, after receiving confirmation from the user, the system begins the acquisition of images and/or videos (referred just as “visual data”) from the external cameras 310a- b (806). In some embodiments, optionally, the system utilizes all cameras, including the front camera 308, during the calibration process. In some embodiments, when there is only one external camera, the user is guided to rotate the device about 180 degrees to position the external camera one time on an upper part of the device, and another time on the bottom part of the device.

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

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

In some embodiments, the system performs an assessment whether at least one external anatomical landmark has been successfully identified (at least from the side of the system - preapproval from user) (812).

In some embodiments, if the answer is “YES”, then (flowchart continues following the letter “A” to Figure 8b), the system requests from the user to approve the identification of a first identified external anatomical landmark (814) - in the case that only one external anatomical landmark was identified, the system requests from the user to approve the identification of the only identified external anatomical landmark.

In some embodiments, the system assesses the input provided by the user, whether the automatic identification was correct (816).

In some embodiments, if the automatic identification was correct, then the system saves the identification of the external anatomical landmark in the database as part of a personalized library for that user (818). In some embodiments, correct automatic identifications are used in future examinations in order to accelerate the calibration process.

In some embodiments, if other external anatomical landmarks were identified, then the system performed actions 814 and 816 until all automatic identifications have been approved by the user (820). In some embodiments, if the automatic identification was incorrect, then the system requests from the user to name the identified external anatomical landmark that was identified (822).

In some embodiments, the system receives the input from the user (824).

In some embodiments, the system then proceeds to action 818 - saving the identification of the external anatomical landmark in the database as part of a personalized library for that user.

Flowchart continues following the letter “C” to Figure 8c.

In some embodiments, the system then assesses if the minimum number of external anatomical landmarks have been identified (826).

In some embodiments, if the answer is “NO”, then the system repeats action 810 forwards until the response of action 826 is “YES” (828).

In some embodiments, if the answer is “YES”, then the system can begin the external examination procedure (see below) (830).

Returning to Figure 8a, if the answer is “NO”, then (flowchart continues following the letter “B” to Figure 8d), the system request from the user to point to a first specific external anatomical landmark (832).

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

In some embodiments, at this point the system performs the action from 806 in Figure 8a forwards, until completion of the calibration process (836).

Referring now to Figure 9, showing a flowchart of an exemplary method of external calibration from the point of view of the user, according to some embodiments of the invention. In some embodiments, an exemplary method of performing external calibration comprises one or more of the following actions:

In some embodiments, the user turns on the self-examination device 102 (902).

In some embodiments, the user positions the self-examination device 102 in front of the vaginal area (904).

In some embodiments, the user sends a confirmation that the self-examination device 102 is in front of the vaginal area (906).

In some embodiments, at this point two possible scenarios can happen, either the selfexamination device 102 succeeded in identifying at least one external anatomical landmark, or not.

In the case where self-examination device 102 succeeded in identifying at least one external anatomical landmark: In some embodiments, the user receives a request to confirm an identified external anatomical landmark (908).

In some embodiments, the user either confirms (910) or refutes (912) the identification of the external anatomical landmark.

In some embodiments, if the user refuted the identification, then the user receives a request to identify the identified external anatomical landmark (914).

In some embodiments, the user provides a proper identification of the identified external anatomical landmark (916).

In some embodiments, the user is then instructed to continue with the medical examination (see below) (918).

In some embodiments, if the user confirmed the identification (910), then the user is instructed to continue with the medical examination (see below) (918).

In the case where self-examination device 102 did not succeeded in identifying at least one external anatomical landmark:

In some embodiments, the user receives a request to point out to a first specific external anatomical landmark (920).

In some embodiments, the user points out to the first specific external anatomical landmark (922).

In some embodiments, the user confirms to the self-examination device 102 using the GUI that the first specific external anatomical landmark is being point out (924).

In some embodiments, the user is either instructed to continue with the medical examination 918 or the calibration process continues from action 908.

Exemplary internal calibration

In some embodiments, similarly to the external calibration explained above, an internal calibration is performed. In some embodiments, the elongated body 306 of the self-examination device 102 is inserted within the bodily orifice, as schematically shown in Figures 10a- 10b.

In some embodiments, once inserted in the bodily orifice, the front camera is used to visualize the internal environment of the bodily orifice. Figure 10c, schematically shows a potential Field Of View (FOV) of the front camera 308 - it should be understood that the actual FOV is dictated by the anatomical constriction of the specific user. In some embodiments, the acquisition of images/videos by the front camera 308 is performed at any time during the insertion of the elongated body 306. For example, the front camera 308 is operated from the beginning of the insertion action until the end of the insertion action, thereby providing images/videos of the whole vaginal canal. In some embodiments, the front camera 308 is configured for visualizing for example the anterior fornix, the posterior fornix, the cervix and any medical situation occurring within the internal environment of the bodily orifice (see below).

In some embodiments, in a similar manner as disclosed above, an internal calibration is performed, with the only difference that instead of looking at external anatomical landmarks, the system searches for internal anatomical landmarks, for example, as mentioned before, one or more of the anterior fornix, the posterior fornix and the cervix.

Exemplary 5 step calibration method

In some embodiments, the calibration process is divided into 5 distinct steps:

Step 1: identifying the following upper external anatomical landmarks: Right labia major, right labia minor, clitoris and urethra.

Step 2: identifying the following lower external anatomical landmarks: Right labia minor, left labia minor, perineum, introitus and anus.

Step 3: identifying the vaginal canal and the cervix - optionally actuating the one or more balloons.

Step 4: identifying the posterior fornix - optionally actuating the one or more balloons.

Step 5: identifying the anterior fornix- optionally actuating the one or more balloons.

Exemplary self-examination methods

In some embodiments, as mentioned above, the self-examination device 102 is used in order to allow an untrained user to perform gynecological self-examinations. In some embodiments, the examinations comprise one or more of visual examinations of external areas, visual examination of internal areas (for example the vaginal canal), ultrasonic examinations and physiological examinations (for example: temperature, pH, humidity, etc.). In some embodiments, the system is configured to allow an untrained user to perform each type of examination by providing the user with detailed instructions. In some embodiments, each action is monitored in order to assess the success of the process, and once the success of a determined action has been corroborated, the system is allowed to move to the next action.

Exemplary external/internal examinations

In some embodiments, after the calibration process, the system begins providing the user instructions in order to allow the system to collect all relevant medical data. Referring now to Figure 11, showing a flowchart of an exemplary method of performing external and/or internal self-examinations, according to some embodiments of the invention. In some embodiments, an exemplary external and/or internal examination comprises one or more of the following actions:

In some embodiments, the method comprises automatically acquiring, using the one or more external cameras - in case the examination is an external examination - or using the front camera - in case the examination is an internal examination, one or more images and/or videos of one or more external/internal anatomical landmarks (1102). In some embodiments, during the internal examination medical data is acquired using the one or more sensors.

In some embodiments, the method comprises automatically assessing that all required images and/or videos (or medical data in general) of all the required external/internal anatomical landmarks have been acquired (1104).

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

In some embodiments, the method comprises automatically analyzing the images and/or videos (medical data) (1108).

In some embodiments, the method comprises automatically identifying one or more attributes related to the external/internal anatomical landmarks based on said analysis (1110). In some embodiments, attributes are provided with a value (quantitative and/or qualitative) which is used for further analysis. In some embodiments, exemplary attributes are one or more of: color of the skin, morphology of the anatomical landmarks, surface of the skin, markings on the skin, texture, skin turgor and particular aroma (particular particles).

In some embodiments, the method comprises automatically comparing the identified attributes with predetermined attributes (1112). In some embodiments, predetermined attributes are based on preliminary examinations performed on the same subject. In some embodiments, predetermined attributes are manually added and/or amended by a dedicated medical personnel (for example the gynecologist).

In some embodiments, the method comprises automatically identifying a difference in the compared attributes according to a predetermined attribute threshold (1114). In some embodiments, the thresholds are quantitative and/or qualitative values provided by the system and/or by the dedicated medical personnel used for differentiating between a state where there is no actual change in the state of the attribute and when there is an actual change in the state of the attribute. For example, the color of the skin is evaluated using the “Fitzpatrick Scale” (see below example of the table of the “Fitzpatrick Scale” showing the six categories of the Fitzpatrick scale in relation to the 36 categories of the older von Luschan scale) which and during a preliminary examination the color of the skin was attribute with a value “white fair”, then during the self- examination, the attribute was identified as “Olive, moderate brown” - this could indicate that there is a medical problem.

In some embodiments, the method comprises automatically generating a preliminary diagnosis based on said identified differences in the compared attributes (1116). In some embodiments, the system is configured to search in a dedicated database possible diagnosis that match the type and size of the change in that specific attribute. For example, following the example above regarding the color of the skin, according to the database, a change in the color of the skin as measured could indicate a possible rash, a type of dermatitis and/or a type of vaginitis.

In some embodiments, the method comprises automatically sending the preliminary diagnosis, together with the relevant data, to dedicated medical personnel (1118).

Exemplary general method

Referring now to Figure 12, showing a flowchart of an exemplary general method, according to some embodiments of the invention. In some embodiments, an exemplary general method comprises one or more of the following actions:

1. Turning the device (1202). In some embodiments, turning on the device optionally causes the device to start recording video to the embedded memory starts taking pictures, optionally high- resolution pictures, every <1 second. 2. Positioning the device in front of the entrance of the vagina (1204). In some embodiments, at this point, within the first seconds, the device saves a picture of the vulva and perineum.

3. Inserting the device into the vagina (1206). In some embodiments, the insertion is performed slowly and monitored by one or more sensors. In some embodiments, if the insertion is too fast, the system will notify the user to amend the speed of insertion. In some embodiments, while entering the vagina, the device performs recordings of the vagina tunnel and the side walls. In some embodiments, the recordings can be done using one or more of: the frontal camera, optionally using a wide field of view; the side cameras; and with the frontal camera tilting to the side and optionally rotating to cover 360 degrees.

4. Providing indication that the device has arrived at the final required/desired position (1208). In some embodiments, the device itself provides the indication. In some embodiments, indications comprise one or more of lights, sounds, images on the electronic device. In some embodiments, the device detects it has reached the final required/desired location (cervix position), optionally the optimal position, using one or more of the following methods: a. The device is manually pushed to the end of the vagina until the device protective dome touches the cervix; b. The camera completed the 5-step marks by demonstrating the anterior and posterior fornixes; c. By using the frontal camera to detect the cervix; and d. The user and/or the doctor/physician see the live-stream video and identifies the cervix.

5. Inflating the balloon (1210). In some embodiments, the balloon is inflated manually by the user/physician and/or automatically by the system. In some embodiments, the balloon is inflated to reach one or more of: a maximum size; the user stops the inflation manually; the balloon reaches a pre-defined pressure level.

6. Taking videos and/or photos (1212). In some embodiments, once the balloon has reached the final diameter, the camera continues to take videos and/or pictures.

7. Deflating the balloon (1214). In some embodiments, at any stage of the balloon inflation or after inflated, if the user pulls the device out, a micro-switch in the device detects the pull and automatically deflates the balloon. In some embodiments, the balloon is deflated manually.

8. Pulling the device outside the vagina (1216). Exemplary automated identification process using Al

In some embodiments, as mentioned above, the system is configured to receive the medical data information, analyze it and provide a preliminary diagnosis. In some embodiments, the system utilizes Al enhancements to learn and improve the diagnostics capabilities of the system. In some embodiments, the system is provided with a plurality of images, videos and/or relevant medical data related to healthy people in order to generate a proper database of predetermined attributes and attributes values of healthy people, which will be used as reference (healthy reference) for future examinations. In some embodiments, the system is provided with a plurality of images, videos and/or relevant medical data related to a plurality of different diseases in order to generate a proper database of predetermined attributes and attributes values of sick people, which will be used as reference (sick reference) for future examinations. In some embodiments, optionally, when a user first acquires the self-examination device 102, the user is requested to perform a first selfexamination in a healthy condition to generate a baseline (healthy baseline), which will be used a baseline for comparison for future self-examinations. In some embodiments, the healthy base baseline is compared to the healthy reference database in order to provide a relationship between the healthy state of the user and the healthy reference - which then will be used by the system to generate a preliminary diagnosis when relevant changes in attributes are found.

Exemplary method of assessing pelvic organ prolapse

In some embodiments, as part of the self-examination process, the system is configured to assess whether the user suffers from pelvic organ prolapse.

It has been reported that about 23.7% of women experience some form of pelvic floor disorder. Common issues range from urinary incontinence (see below) to several kinds of pelvic organ prolapse (POP). A “prolapse” is the slipping down or forward of a part or organ, often as a result of weakened or stretched connective tissue.

Exemplary types of Pelvic Organ Prolapse include (from https://www(dot)advancedgynecology(dot)com/2020/the-major-types-of-pelvic-organ-prolapse- and-their-differences/) :

Cystocele - A prolapsed bladder sinks into the anterior wall of the vagina.

Cystocele (or “dropped bladder”) is the most common type of female prolapse and one of the few types of bladder prolapse that may impact the body. Basically, the bladder’s supportive tissue stretches or detaches and sinks against the front (or anterior) vaginal wall at the top of the vagina. This may result in difficulty passing urine, incontinence, pain while having sex or general discomfort.

Urethrocele - The prolapsed urethra sinks into the anterior wall of the vagina.

This is another prolapse that affects the anterior vaginal wall. This type of prolapse affects only the urethra, which is a tube that takes urine away from the body from the bladder. It may lead to incontinence and frequent or urgent urination.

Cystourethrocele - Both the bladder prolapse (cystocele) and urethra prolapse (urethrocele) occur together.

This bladder prolapse affects both the bladder and the urethra, which sink into the anterior wall of the vagina together.

Uterine Prolapse - The uterus droops into the vaginal space and may even protrude outside of the vagina.

The uterus is a powerful, muscular organ that stretches during childbirth and pregnancy, but a dropped uterus can cause quite a few problems. It may lead to other prolapses on this list, as the weight of this organ puts pressure on other weakened organs, causing them to sink. A uterine prolapse, if it goes completely unaddressed and untreated, can painfully protrude outside of the vagina in a disorder called procidentia. A prolapsed uterus can feel like you’re sitting on a ball, lead to beading and may lead to pain during sex.

Vaginal Vault Prolapse - The top part of the vaginal wall droops towards the vaginal canal.

This type is common for women who have undergone a hysterectomy. Because the uterus has been removed, nothing is anchoring the top of the vagina or cervix in place, and it may sometimes sink. In very severe cases, the vagina may fall through the opening.

Vaginal Prolapse - The vagina itself droops until it protrudes from the body.

A vaginal prolapse is slightly different than a vaginal vault prolapse. This is where the vagina and the ligaments, muscles and skin around it seem to sink and fall out of normal position. This is typically in combination with other types of prolapse on this list.

Enterocele - The small intestine prolapses into the upper wall of the vagina. In some cases, the small bowel, or small intestine may sink into the lower pelvic cavity, affecting the top part of the vagina.

Rectocele - The rectum bulges into the posterior vaginal wall.

This type of rectum prolapse only affects women, in which the posterior wall of the vagina (a normally thick band of muscle between the vagina and rectum) is weakened. In severe cases, this bulge may tear into the vagina. Earlier stages may cause rectal pain, constipation, a feeling of pressure in the rectum or the feeling that the bowel hasn’t emptied even after finishing a bowel movement.

Rectal Prolapse - The rectum droops and protrudes through the anus.

The tissues and muscles around the rectal passage loosen, until the rectum may protrude through the anus. People may experience symptoms such as fecal incontinence, urgent bowel movements, or leaking blood or mucus from the anus.

Descending Perineum Syndrome - The perineum sinks down below its normal place on the pelvis.

Excessive trauma to the area may cause the perineum to sink. The perineum is the space between the vulva and the anus. This pelvic floor prolapse affects the whole region, which bulges down beyond its space, which is normally the bony part of the pelvis.

All these prolapses have a lot of potential causes. Pregnancy, childbirth, menopause, having a hysterectomy, excessive heavy lifting, smoking, weight, long-term health conditions that cause constipation, long-term conditions that cause frequent cough or strain, age and specific conditions (such as Marfan syndrome) all increase the risks of different forms of pelvic organ prolapse.

In some embodiments, during the self-examinations, the system is configured to collect relevant medical data in order to revel whether the user is suffering from any of the abovementioned pelvic organ prolapses.

For example, the system is configured to perform a pelvic organ prolapse assessment using the Pelvic Organ Prolapse Quantifications System (POP-Q).

POP-Q is a system for assessing the degree of prolapse of pelvic organs to help standardize diagnosing, comparing, documenting, and sharing of clinical findings. This assessment is the most frequently used among research publications related to pelvic organ prolapse. When assessed using the POP-Q, the prevalence of pelvic organ prolapse is estimated to be up to 50% while diagnosis by symptoms has a prevalence of 3-6%. The POP-Q quantifies the descent of pelvic organs into the vagina. The POP-Q provides reliable description of the support of the anterior, posterior and apical vaginal wall. It uses objective and precise distance measurements to the reference point, the hymen. Cystocele and prolapse of the vagina from other causes is staged using POP-Q criteria and can range from good support (no descent into the vagina) reported as a POP-Q stage 0 or I to a POP-Q score of IV, which includes prolapse beyond the hymen. It also used to quantify the movement of other structures into the vaginal lumen and their descent.

Referring now to Figure 13a, showing a schematic representation of the POP-Q system locations.

In some embodiments, the following measurement parameters are used in the POP-Q test: The plane of the hymen being defined as zero, all measures are in centimeters above / proximal (negative number) or below / distal (positive number) to the hymen. The measurement parameters are made up of six distinct locations (Aa, Ba, C, D, Ap, Bp):

Point Aa is at the midline of anterior vaginal wall. Where no prolapse is present this location is 3cm up from the hymen (merely interior to the vaginal opening). Parameters from the hymen can be -3cm indicating no anterior vaginal prolapse or +3cm, which is a full prolapse.

Point Ba refers to the most distal portion of the remaining upper anterior side of the vaginal wall. This location coexists with Aa (-3cm) in a woman with no anterior prolapse. However, in a woman with full prolapse, this location coexists with point C. Its location can range from -3 to +6 or +7 in severe cases.

Point C is the lowest edge of the cervix or the vaginal cuff (i.e. hysterectomy scar). This location identifies if the cervix is descending.

Point D is the topmost point of the posterior vaginal wall. This location can be contrasted with Point C to assess if the entry to the cervix has been extended.

Point Ap is located midline of posterior vaginal wall 3cm proximal to hymen. The parameters for this point can range from -3cm to +3cm relative to hymen.

Point Bp refers to the most distal portion of the remaining upper posterior side of the vaginal wall. Its location can range from -3 to +6 or +7 in severe cases.

Furthermore, three anatomical markers (GH, PB, TVL) can be examined:

GH is the 'Genital hiatus' that records the length from the urethral opening to the posterior vaginal opening/ hymen. The hiatus refers to the opening in puborectalis muscle, a component of the levator ani muscle group. A larger distance here may indicate laxity in this area. PB is the 'perineal body' and is recorded from the posterior aspect of hymen to the mid-anal opening. This will give an insight to the tonicity of superficial pelvic floor. Through vaginal birth the perineal body can be injured via tears or by an episiotomy.

TVL refers to 'total vaginal length' measured from hymen to the most distal point. Knowing this allows the depth of prolapse to be assessed and reassessed post-surgical repair.

As mentioned above, the POP-Q assessment tool measures nine points in the vagina. The hymen is the reference point to which the other points are compared. The prolapsed organs are measured in centimeters to the hymen. The anatomical landmarks used are anterior vaginal wall, cervix, hymen, perineal body, total vaginal length, posterior vaginal wall and posterior fornix. A three-by-three centimeter grid is used to record the proximal and distal numbers. The information on the grid is translated to the appropriate stage of prolapse.

Exemplary stages include:

Figures 13b and 13c, show schematic representations of exemplary measurements of the organs.

Exemplary method of performing the measurements using the system

In some embodiments, as mentioned above, POP-Q assessment is performed by doing a plurality of measurements between preset anatomical landmarks. In some embodiments, the system is configured to perform the plurality of measurements utilizing the elongated body 306, the front camera 308, the one or more external cameras 310a-b and optionally one or more sensors from the one or more sensors 204. In some embodiments, as mentioned above, the self-examination device 102 comprises an elongated body 306, which optionally is a telescopic elongated body. The following explanations will related to the embodiment where the elongated body 306 comprises a fixed length and following these explanations, further explanations will be provided with relation to the telescopic elongated body.

Exemplary method using a self-examination device 102 having an elongated body 306 that comprises a fixed length

Referring now to Figure 14 showing a schematic representation of an exemplary selfexamination device 102 for the use of performing measurements, according to some embodiments of the invention. In some embodiments, the system utilizes a plurality of distances and/or a relation between distances in order to perform the measurements required for the POP-Q assessment. In some embodiments, the distances used by the system are one or more of:

1. The length of the elongated body 306, defined as DI. In some embodiments, DI also equals the distance between the one or more external cameras 310a-b and the front camera 308.

2. An estimated distance and/or a measured distance between the front camera 308 and a certain landmark captured within the FOV of the front camera 308, defined as D2.

3. An estimated distance and/or a measured distance between one or more external cameras 310a-b and a certain landmark captured within the FOV of the one or more external cameras 310a- b, defined as D3.

4. A sensed/measured distance performed by moving the self-examination device 102, as measured for example by a sensor 204 (for example, an accelerometer), defined as D4.

Referring now to Figures 15a- 15b, showing a flowchart of an exemplary method of performing a POP-Q assessment by the system, according to some embodiments of the invention. In some embodiments, an exemplary method of performing a POP-Q assessment comprises one or more of the following actions:

1. Setting the location of the reference anatomical landmark (for example the hymen) (1502). In some embodiments, setting the location of the reference anatomical landmark is performed by identifying the hymen with one or more of the frontal camera 308 and the one or more external cameras 310a-b. In some embodiments, if the anatomical landmark is identified only by the front camera 308, then the location of the anatomical landmark in relation to the device is done by using for example the distances DI and D2. In some embodiments, if the anatomical landmark is identified by the one or more external cameras 310a-b, then the location of the anatomical landmark in relation to the device is D3. It should be understood that any combination of the abovementioned measurements of distances can be used to set the location of the anatomical landmark in relation to the device.

2. Moving the elongated body 306 within the bodily orifice (1504) and generating a timeline of data collection while performing the movement.

3. Performing a plurality of data collection while moving the elongated body 306 within the bodily orifice (1506) - including one or more of: a. acquiring a plurality of images and/or videos with the front camera 308. b. acquiring a plurality of images and/or videos with the one or more external cameras 310a-b. c. acquiring a plurality of sensory data from the one or more sensors 204.

4. Associating the acquired data with the timeline of data collection (1508).

5. Analyzing the collected data to identify further required anatomical landmarks (1510).

6. Calculating a distance between the front camera 308 and the newly identified landmarks (1512).

(Flowchart continues following the letter “D” to Figure 15b)

7. Calculating a distance between the reference landmark and the newly identified landmarks based on the result of the previously performed calculations (1514).

8. Comparing the measured distances between the reference landmark and the newly identified landmarks with values of distances located in a reference database (1516).

9. Evaluating, based on the comparison, if the measured distances between the reference landmark and the newly identified landmarks are below or above a predefined threshold (1518).

10. Generating a diagnosis based on said evaluation (1520). In some embodiments, the diagnosis is provided based on predetermined possible diagnosis provided in the database according to the different possible results of the measurements required in a POP-Q assessment.

In some embodiments, the diagnosis is sent to a dedicated medical personnel for further evaluation and approval.

Exemplary method using a self-examination device 102 having a telescopic elongated body 306 that comprises a variable length

Referring now to Figure 16 showing a schematic representation of an exemplary selfexamination device 102 for the use of performing measurements, according to some embodiments of the invention. In some embodiments, same as disclosed above, the system utilizes a plurality of distances and/or a relation between distances in order to perform the measurements required for the POP-Q assessment. In some embodiments, the distances used by the system are one or more of:

1. The length of the telescopic elongated body 306, defined as DI’. In some embodiments, the system is provided with a value of the maximal distance that DI’ can be (also referred to DI ’max ), which equals to the maximum length to which the telescopic elongated body can be extended. In some embodiments, DI ’max— DI. In some embodiments, additionally, the system is provided with a value of the minimal distance that DI’ can be (also referred to Dl’min), which equals to the minimum length to which the telescopic elongated body can be retracted. In some embodiments, at any point the value of DI’ also equals the distance between the one or more external cameras 310a-b and the front camera 308. In some embodiments, the system is configured to know at any moment the actual value of DI’ while the telescopic elongated body 306 is being actuated.

Referring now to Figures 17a- 17b, showing a flowchart of an exemplary method of performing a POP-Q assessment by the system, according to some embodiments of the invention. In some embodiments, an exemplary method of performing a POP-Q assessment comprises one or more of the following actions:

1. Setting the location of the reference landmark (for example the hymen) with the elongated body completely retracted (meaning Dl’min) (1702). In some embodiments, setting the location of the reference landmark is performed by identifying the hymen with one or more of the frontal camera 308 and the one or more external cameras 310a-b. In some embodiments, if the landmark is identified only by the front camera 308, then the location of the landmark in relation to the device is done by using for example the distances Dl’min and D2. In some embodiments, if the landmark is identified by the one or more external cameras 310a-b, then the location of the landmark in relation to the device is D3. It should be understood that any combination of the abovementioned measurements of distances can be used to set the location of the landmark in relation to the device. 2. Moving the distal end of the elongated body 306 within the bodily orifice (1704).

3. Actuating the telescopic mechanism to cause the elongated body to move from DI ’min to D l ’max and generating a timeline of data collection while performing the actuation (1706).

3. Performing a plurality of data collection while actuating the elongated body 306 within the bodily orifice (1708) - including one or more of: a. acquiring a plurality of images and/or videos with the front camera 308. b. acquiring a plurality of images and/or videos with the one or more external cameras 310a-b. c. acquiring a plurality of sensory data from the one or more sensors 204.

4. Associating the acquired data with the timeline of data collection (1710).

5. Analyzing the collected data to identify further required landmarks (1712).

6. Calculating a distance between the front camera 308 and the newly identified landmarks (1714).

(Flowchart continues following the letter “D” to Figure 17b)

7. Calculating a distance between the reference landmark and the newly identified landmarks based on the result of the previously performed calculations (1716).

8. Comparing the measured distances between the reference landmark and the newly identified landmarks with a reference database (1718).

9. Evaluating, based on the comparison, if the measured distances between the reference landmark and the newly identified landmarks are below or above a predefined threshold (1720).

10. Providing a diagnosis based on said evaluation (1722). In some embodiments, the diagnosis is provided based on predetermined possible diagnosis provided in the database according to the different possible results of the measurements required in a POP-Q assessment.

Exemplary assessment of pelvic prolapse using pressure sensors

In some embodiments, the internal pressure sensors are configured to be actuated during the insertion of the elongated body (either fixed length or variable length). In some embodiments, the system is configured to measure the pressure and compare the sensed value with a predetermined baseline value. In some embodiments, if the system senses a value which is above a predetermined threshold, the system will generate a preliminary diagnosis of pelvic prolapse. In some embodiments, the preliminary diagnosis is sent to a dedicated medical personnel. Exemplary method of assessment of urinary incontinence

In some embodiments, the system is configured to assess whether the user is suffering from urinary incontinence.

Referring now to Figure 18, showing a schematic representation of an exemplary position of the self-examination device 102 for assessing urinary incontinence, according to some embodiments of the invention. In some embodiments, the system is configured to instruct the user to insert the self-examination device 102 into the bodily orifice until the front camera 308 visualizes the cervix, located in the FOV1 of the front camera 308, while one of the one or more external cameras 310a-b visualize the urethra and/or anus, located in the FOV2 of the one of the one or more external cameras 310a-b, and possible urine 1802 exiting the urethra. In some embodiments, both the cervix (internally) and the urethra (externally) are visualized at a same time.

Referring now to Figure 19 showing a flowchart of an exemplary method of assessing urinary incontinence by the system, according to some embodiments of the invention. In some embodiments, an exemplary method of assessing urinary incontinence comprises one or more of the following actions:

1. Inserting the elongated body into the bodily orifice (1902).

2. Assessing visualization of the cervix (1904).

3. Assessing visualization of the urethra/anus while keeping visualization of the cervix (1906).

In some embodiments, the order of visualizations can change, first the urethra is visualized and then the cervix is visualized.

4. Optionally instructing the patient to enter a specific stance (1908). In some embodiments, stances can be standing, sitting, squatting, laying down on the back and laying down on the side.

5. Instructing the user to perform an effort or physical exertion, for example coughing (1910).

6. Acquiring one or more images and/or videos from the front camera 308, the one or more external cameras 310a-b and from the internal sensors 204 (for example the pressure sensors) located inside the elongated body 306 (1912).

7. Analyzing collected data (1914).

8. Assessing, based on said analysis, whether one or more of the following occurred (1916): a. an abnormal mobilization of the cervix occurred; b. an abnormal pressure was sensed in the pressure sensors; c. urine was detected exiting the urethra and/or excrements from the anus. In some embodiments, the results from the assessment are sent to a dedicated medical personnel for further actions.

Exemplary use of the system for physiotherapy

In some embodiments, the self-examination device 102 and the one or more balloons 314/316 are used to provide physiotherapy to the anterior vaginal compartment and/or posterior vaginal compartment applying feedback from the pelvic muscles constriction and relaxation monitored both by the front camera and the pressure sensors. In some embodiments, the one or more balloons will also serve as a platform to apply the pelvic physiotherapy and feedback to the patient.

As used herein with reference to quantity or value, the term “about” means “within ± 20% of’.

The terms “comprises”, “comprising”, “includes”, “including”, “has”, “having” and their conjugates mean “including but not limited to”.

The term “consisting of’ means “including and limited to”.

The term “consisting essentially of’ means that the composition, method or structure may include additional ingredients, steps and/or parts, but only if the additional ingredients, steps and/or parts do not materially alter the basic and novel characteristics of the claimed composition, method or structure.

As used herein, the singular forms “a”, “an” and “the” include plural references unless the context clearly dictates otherwise. For example, the term “a compound” or “at least one compound” may include a plurality of compounds, including mixtures thereof.

Throughout this application, embodiments of this invention may be presented with reference to a range format. It should be understood that the description in range format is merely for convenience and brevity and should not be construed as an inflexible limitation on the scope of the invention. Accordingly, the description of a range should be considered to have specifically disclosed all the possible subranges as well as individual numerical values within that range. For example, description of a range such as “from 1 to 6” should be considered to have specifically disclosed subranges such as “from 1 to 3”, “from 1 to 4”, “from 1 to 5”, “from 2 to 4”, “from 2 to 6”, “from 3 to 6”, etc.; as well as individual numbers within that range, for example, 1, 2, 3, 4, 5, and 6. This applies regardless of the breadth of the range.

Whenever a numerical range is indicated herein (for example “10-15”, “10 to 15”, or any pair of numbers linked by these another such range indication), it is meant to include any number (fractional or integral) within the indicated range limits, including the range limits, unless the context clearly dictates otherwise. The phrases “range/ranging/ranges between” a first indicate number and a second indicate number and “range/ranging/ranges from” a first indicate number “to”, “up to”, “until” or “through” (or another such range-indicating term) a second indicate number are used herein interchangeably and are meant to include the first and second indicated numbers and all the fractional and integral numbers therebetween.

Unless otherwise indicated, numbers used herein and any number ranges based thereon are approximations within the accuracy of reasonable measurement and rounding errors as understood by persons skilled in the art.

As used herein the term “method” refers to manners, means, techniques and procedures for accomplishing a given task including, but not limited to, those manners, means, techniques and procedures either known to, or readily developed from known manners, means, techniques and procedures by practitioners of the chemical, pharmacological, biological, biochemical and medical arts.

It is appreciated that certain features of the invention, which are, for clarity, described in the context of separate embodiments, may also be provided in combination in a single embodiment. Conversely, various features of the invention, which are, for brevity, described in the context of a single embodiment, may also be provided separately or in any suitable subcombination or as suitable in any other described embodiment of the invention. Certain features described in the context of various embodiments are not to be considered essential features of those embodiments, unless the embodiment is inoperative without those elements.

Various embodiments and aspects of the present invention as delineated hereinabove and as claimed in the claims section below find support in the following examples.

EXAMPLES OF DATA PROVIDED TO THE Al

Reference is now made to the following examples, which together with the above descriptions illustrate some embodiments of the invention in a non limiting fashion.

In some embodiments, as mentioned above the system is configured to receive the medical data information, analyze it and provide a preliminary diagnosis. In some embodiments, the system utilizes Al enhancements to learn and improve the diagnostics capabilities of the system. In some embodiments, the system is provided with a plurality of images, videos and/or relevant medical data related to healthy people in order to generate a proper database of predetermined attributes and attributes values of healthy people, which will be used as reference (healthy reference) for future examinations. In some embodiments, the system is provided with a plurality of images, videos and/or relevant medical data related to a plurality of different diseases in order to generate a proper database of predetermined attributes and attributes values of sick people, which will be used as reference (sick reference) for future examinations.

Referring now to Figures 20a-20n, showing exemplary visual data provided to the Al, according to some embodiments of the invention.

Figure 20a shows an exemplary image of a healthy labia minor.

Figure 20b shows an exemplary image of a vagina suffering from lichen sclerosis.

Figure 20c shows an exemplary image of a patient suffering from Paget’s disease.

Figure 20d shows an exemplary image of a patient suffering from vulvar cancer.

Figure 20e shows an exemplary image of a patient suffering from cervix erosions (top of the picture and arrows).

Figure 20f shows an exemplary image of a patient suffering from eruption in the vaginal canal caused by drug reaction.

Figure 20g shows an exemplary image of a patient suffering from vaginitis.

Figure 20h shows an exemplary image of a patient suffering from atrophic vaginitis.

Figure 20i shows an exemplary image of a patient suffering from yeast/candida infection.

Figure 20j shows an exemplary image of a normal healthy cervix.

Figure 20k shows an exemplary image of a patient suffering from Cervical Intraepithelial Neoplasia (CIN) in different stages (1-3).

Figure 201 shows an exemplary image of a normal healthy posterior fornix.

Figure 20m shows an exemplary image of a normal healthy anterior fornix (top arrow).

Figure 20n shows an exemplary image of a patient suffering from rectal prolapse.

Although the invention has been described in conjunction with specific embodiments thereof, it is evident that many alternatives, modifications and variations will be apparent to those skilled in the art. Accordingly, it is intended to embrace all such alternatives, modifications and variations that fall within the spirit and broad scope of the appended claims.

It is the intent of the applicant(s) that all publications, patents and patent applications referred to in this specification are to be incorporated in their entirety by reference into the specification, as if each individual publication, patent or patent application was specifically and individually noted when referenced that it is to be incorporated herein by reference. In addition, citation or identification of any reference in this application shall not be construed as an admission that such reference is available as prior art to the present invention. To the extent that section headings are used, they should not be construed as necessarily limiting. In addition, any priority document(s) of this application is/are hereby incorporated herein by reference in its/their entirety.

Claims

WHAT IS CLAIMED IS:

1. A method for performing a medical examination with a self-examination device, comprising: a. acquiring one or more images and/or videos of one or more external anatomical landmarks and/or one or more internal anatomical landmarks; b. analyzing said acquired one or more images and/or videos; comprising i. identifying one or more attributes related to said one or more external anatomical landmarks and/or said one or more internal anatomical landmarks based on said analysis; ii. comparing said identified attributes with predetermined attributes; iii. identifying a difference in said compared attributes according to a predetermined attribute threshold; c. generating a preliminary diagnosis based on said identified differences in said compared attributes in said analysis.

2. The method according to claim 1, further comprising performing a calibration process; said calibration process comprising: a. automatically identifying said one or more external anatomical landmarks; and b. automatically identifying said one or more internal anatomical landmarks.

3. A method for performing a medical examination with a self-examination device, comprising: a. positioning said self-examination device in front of an organ of interest; b. acquiring one or more images and/or videos of an external area of said organ of interest; c. inserting a part of said self-examination device within a bodily orifice of said organ of interest; d. acquiring one or more images and/or videos of an internal area of said organ of interest; e. analyzing said acquired one or more images and/or videos; comprising: i. comprising identifying one or more external anatomical landmarks in said external area and identifying one or more internal anatomical landmarks in said internal area; ii. identifying one or more attributes related to said one or more external anatomical landmarks and/or said one or more internal anatomical landmarks based on said analysis; iii. comparing said identified attributes with predetermined attributes; iv. identifying a difference in said compared attributes according to a predetermined attribute threshold; f. generating a preliminary diagnosis based on said identified differences in said compared attribute in said analysis.

4. The method according to claim 3, further comprising performing a calibration process; said calibration process comprising: a. automatically identifying said one or more external anatomical landmarks; and b. automatically identifying said one or more internal anatomical landmarks.

5. A method for performing an automated POP-Q medical examination with a selfexamination device, comprising: a. setting a location of a reference anatomical landmark; b. inserting a part of said self-examination device within a bodily orifice; c. generating a timeline of data collection while performing said inserting; d. acquiring a plurality of data collection while said inserting; e. associating said acquired plurality of data with said timeline of data collection; f. analyzing said acquired plurality of data for identifying anatomical landmarks; g. calculating a distance between a predetermined location on said self-examination device and said identified landmarks; h. calculating a distance between said reference anatomical landmark and said identified landmarks based on a result said calculating; i. comparing said calculated distances between said reference anatomical landmark and said identified landmarks with distances values in a reference database; j. evaluating, based on the comparison, if said calculated distances are below or above a predefined threshold; k. generating a diagnosis based on said evaluation.

6. The method according to claim 5, wherein said acquiring a plurality of data collection comprises one or more of: a. acquiring a plurality of images and/or videos with a front camera of said self-examination device; b. acquiring a plurality of images and/or videos with the one or more external cameras of said self-examination device; and c. acquiring a plurality of sensory data from one or more sensors of said self-examination device.

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

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

9. The method according to claim 5, wherein said anatomical landmarks are one or more of a midline of anterior vaginal wall, a most distal portion of a side of said anterior vaginal wall, a lowest edge of a cervix, a topmost point of the posterior vaginal wall, a midline of posterior vaginal wall, a most distal portion of a side of said posterior vaginal wall, an urethral opening, a posterior vaginal opening and a mid-anal opening.

10. The method according to claim 5, wherein said predetermined location on said selfexamination device is one or more of a most distal end of said self-examination device, a location of a camera located at a most distal end of said self-examination device, a location of one or more external cameras located on said self-examination device.

11. The method according to claim 5, wherein said inserting comprises telescopically actuating said part of said self-examination device while maintaining immobile a rest of said selfexamination device.

12. A method for performing an automated assessment of urinary incontinence in a patient with a self-examination device, comprising: a. inserting a part of said self-examination device within a bodily orifice; b. visualizing a cervix within said bodily orifice; c. visualizing a urethra while keeping said visualizing of said cervix; d. instructing said patient to perform an effort and/or a physical exertion; e. acquiring one or more medical data using said self-examination device while said patient performs said effort and/or a physical exertion; f. analyzing said acquired medical data; g. assessing, based on said analysis, whether one or more of the following occurred: i. an abnormal mobilization of the cervix occurred; ii. an abnormal pressure was sensed in the pressure sensors; iii. urine was detected exiting the urethra.

13. The method according to claim 12, further comprising instructing said patient to enter a specific stance.

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

15. The method according to claim 12, wherein said acquiring is from one or more of a front camera, one or more external cameras and one or more sensors located inside said selfexamination device.

16. The method according to claim 12, wherein said medical data are one or more of images, videos, physiological measurements and pressure measurements.

17. A device for performing medical self-examinations, comprising: a. an elongated body having a proximal end and a distal end; said distal end being configured to be inserted into a bodily orifice of a subject; b. a transparent protective dome positioned at said distal end of said elongated body; c. a base connected to said proximal end of said elongated body; said base comprising at least one motor; d. one or more frontal imaging devices located within said elongated body and configured to move along and within said elongated body by means of said motor; said one or more frontal imaging devices having a field of view (FOV) through said transparent protective dome; said one or more frontal imaging devices being configured to obtain one or more images and/or videos of an internal environment of said bodily orifice of the subject; e. a processor located within said base; said processor comprising instructions for guiding said subject through a self-examination process.

18. The device according to claim 17, further comprising one or more external imaging devices located on said base and facing towards said elongated body; said one or more external imaging devices being configured to obtain one or more images and/or videos of an external environment of said bodily orifice of the subject;

19. The device according to claim 17, further comprising a plurality of sensors.

20. The device according to claim 19, wherein said plurality of sensors are one or more of visual sensors, ultrasonic sensors, temperature sensors, pressure sensors, humidity sensors, pH sensors, location sensors, position sensors and force sensors.

21. The device according to claim 19, wherein said plurality sensors are disposed on an exterior surface of said elongated body; said plurality sensors being configured for measuring one or more set of parameters of said internal environment of said bodily orifice of said subject comprising at least one of impedance, pH and pressure.

22. The device according to claim 19, wherein said plurality of sensors comprise at least one laser-based distance sensor.

23. The device according to claim 22, wherein said at least one laser-based distance sensor is positioned near said one or more frontal imaging devices.

24. The device according to claim 17, further comprising one or more integrated light sources adjacent to said one or more frontal imaging devices and/or said one or more external imaging devices.

25. The device according to claim 17, further comprising a graphical interface unit (GUI), said GUI comprising one or more controls.

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

27. The device according to claim 26, wherein said device comprises controls configured to inflate and deflate said first inflatable member.

28. The device according to claim 26, wherein said first inflatable member is either mono-body or multi-body.

29. The device according to claim 26, wherein said first inflatable member is either single- weld or multi-weld.

30. The device according to claim 26, wherein said first inflatable member comprises a body that is either isometric or non- isometric.

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

32. The device according to claim 17, wherein said elongated body is a telescopic elongated body configured for extending and retracting.

33. The device according to claim 17, wherein said elongated body is flexible.

34. The device according to claim 33, wherein said elongated body is configured for taking a shape and/or for following a shape of said bodily orifice.

35. The device according to claim 17, further comprising one or more of: a. at least one power supply configured for providing power to said device; b. at least one pump connected to a first inflatable member and a second inflatable member; and c. a communication unit comprising at least one of a wireless and a non-wireless communication interface.

36. The device according to claim 17, wherein said processor comprises further instructions for performing any of the methods according to claims 1, 3, 5 and/or 12.