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WO2025099717A2 - Système et procédés d'examens gynécologiques - Google Patents

Système et procédés d'examens gynécologiques Download PDF

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Publication number
WO2025099717A2
WO2025099717A2 PCT/IL2024/051060 IL2024051060W WO2025099717A2 WO 2025099717 A2 WO2025099717 A2 WO 2025099717A2 IL 2024051060 W IL2024051060 W IL 2024051060W WO 2025099717 A2 WO2025099717 A2 WO 2025099717A2
Authority
WO
WIPO (PCT)
Prior art keywords
self
examination
sensors
external
elongated body
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
PCT/IL2024/051060
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English (en)
Other versions
WO2025099717A3 (fr
Inventor
Einat Hila TZUR
Shlomo Bezalel COHEN-EYLON
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Gynecheck Ltd
Original Assignee
Gynecheck Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Gynecheck Ltd filed Critical Gynecheck Ltd
Publication of WO2025099717A2 publication Critical patent/WO2025099717A2/fr
Publication of WO2025099717A3 publication Critical patent/WO2025099717A3/fr
Pending legal-status Critical Current
Anticipated expiration legal-status Critical

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A61B1/00064—Constructional details of the endoscope body
    • A61B1/00071—Insertion part of the endoscope body
    • A61B1/0008—Insertion part of the endoscope body characterised by distal tip features
    • A61B1/00082—Balloons
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A61B1/00002—Operational features of endoscopes
    • A61B1/00004—Operational features of endoscopes characterised by electronic signal processing
    • A61B1/00009—Operational features of endoscopes characterised by electronic signal processing of image signals during a use of endoscope
    • A61B1/000094—Operational features of endoscopes characterised by electronic signal processing of image signals during a use of endoscope extracting biological structures
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A61B1/00064—Constructional details of the endoscope body
    • A61B1/00071—Insertion part of the endoscope body
    • A61B1/0008—Insertion part of the endoscope body characterised by distal tip features
    • A61B1/00097—Sensors
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A61B1/00064—Constructional details of the endoscope body
    • A61B1/00108—Constructional details of the endoscope body characterised by self-sufficient functionality for stand-alone use
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A61B1/04—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor combined with photographic or television appliances
    • A61B1/05—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor combined with photographic or television appliances characterised by the image sensor, e.g. camera, being in the distal end portion
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A61B1/303—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor for the vagina, i.e. vaginoscopes

Definitions

  • 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.
  • 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 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.
  • LED light emitting diode
  • 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.
  • 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.
  • 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 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 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 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.
  • 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.
  • 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.
  • the materials, methods, and examples are illustrative only and are not intended to be necessarily limiting.
  • 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.
  • a data processor such as a computing platform for executing a plurality of instructions.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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).
  • FAN local area network
  • WAN wide area network
  • Internet Service Provider for example, AT&T, MCI, Sprint, EarthLink, MSN, GTE, etc.
  • 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.
  • 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.
  • 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 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.
  • 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.
  • An aspect of some embodiments of the invention relates to self-performed gynecological medical examinations.
  • the examinations are performed using a dedicated device configured for guiding a non-professional user over one or more steps of the medical examination.
  • 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.
  • data from the medical examination is provided to a medical professional.
  • data from the medical examination is automatically analyzed to provide medical insights to a medical professional and/or a user.
  • analyzed medical data is used for diagnosing a patient.
  • the diagnosing is automatic.
  • 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.
  • 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.
  • 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.
  • 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).
  • the dedicated device 102 is connected to one or more servers 104 (referred hereinafter just as “server”).
  • medical data collected by the self-examination device 102 is sent to the server 104.
  • the server 104 comprises instructions to analyze the medical data received by the self-examination device 102.
  • 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.
  • 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).
  • the self-examination device 102 comprises the minimal software and hardware to perform analysis on the medical data (see below).
  • 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.
  • 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.
  • the system is configured to store and/or provide raw medical data and/or analyzed medical data.
  • 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.
  • an exemplary self-examination device 102 comprises an external case 202 configured to encase one or more electronic components.
  • the self-examination device 102 comprises one or more sensors 204.
  • the one or more sensors are more than one type of sensor.
  • the one or more sensors are a plurality of a same type of sensor.
  • the one or more sensors are a plurality of types of sensors where there are a plurality of sensors of each type.
  • the self-examination device 102 comprises one or more controllers 206 (one shown in Figure 2 - and referred hereinafter just as “controller”).
  • 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.
  • the selfexamination device 102 comprises one or more memory modules 208.
  • 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).
  • 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.
  • the GUI 212 is an integral part of the self-examination device 102.
  • 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.
  • 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.
  • the power is provided by a battery, optionally a rechargeable battery.
  • power is provided by a cable connected to the self-examination device 102.
  • the self-examination device 102 comprises one or more pumps 214 configured for inflating one or more balloons (see below).
  • an exemplary self-examination device 102 comprises a handle 302 located at a proximal end of the self-examination device 102.
  • 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.
  • the handle 302 is connected to the main body 304.
  • the handle 302 is also configured for housing at least part of the electrical components.
  • the handle 302 and the main body 304 are one and the same.
  • 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.
  • the elongated body 306 is configured to house at least part of the electronic components (see below).
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • an exemplary self-examination device 102 comprises one or more sensors.
  • 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.
  • 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.
  • 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.
  • the self-examination device 102 comprises a frontal camera 308, optionally comprising one or more light sources (not shown).
  • 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.
  • 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.
  • the frontal camera 318 is in a fixed position at the most distal end of the elongated body 308 (behind the dome 318).
  • the self-examination device 102 optionally comprises one or more external cameras 310a-b, each optionally comprising one or more light sources (not shown).
  • 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.
  • 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.
  • the self-examination device 102 comprises a single external camera.
  • 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.
  • the one or more sensors 312 are configured to collect medical data from within the internal environment of the bodily orifice of the subject.
  • 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.
  • the self-examination device 102 comprises a frontal camera 308.
  • the frontal camera 308 is positioned within the elongated body 306.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • the motorized frontal camera 308 is controlled manually and/or automatically with smart control logic, by the user and/or remotely by the physician.
  • 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).
  • FIG. 3f-3j showing schematic representation of exemplary inflation mechanism of an exemplary self-examination device 102, according to some embodiments of the invention.
  • an inflatable element 314 for example a balloon, configured to be inflated within the internal environment of the bodily orifice of the subject.
  • the inflatable element 314 is shown in a deflated configuration, while in Figure 3g, the inflatable element 314 is shown in an inflated configuration.
  • 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.
  • 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.
  • the one or more balloons are automatically operated to allow the cameras to visualize the internal anatomical landmarks (see below).
  • 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.
  • the system is semi-automatic, which means that the system provide instructions to the user to either inflate or deflate the balloons.
  • 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.
  • the one or more balloons are compartmentalized balloons and each compartment can be inflated/deflated independently to the others.
  • 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.
  • 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.
  • 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.
  • 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).
  • the inflatable element comprises either a single weld (referred hereinafter as single-weld) or comprises two or more welds (referred hereinafter as multi-weld).
  • FIGS 4c-4e schematically showing an exemplary inflatable element 402 mounted on an elongated body, according to some embodiments of the invention.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • FIGs 4j-4k schematically showing an exemplary inflatable element 416 mounted on an elongated body, according to some embodiments of the invention.
  • 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.
  • 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.
  • Figure 41 shows a multi-body inflatable isometric element 428.
  • 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.
  • 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.
  • 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.
  • two inflatable bodies 430a/430b are bigger in size than the others.
  • 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.
  • 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.
  • FIG. 4n-4o schematically showing an exemplary inflatable element 436 mounted on an elongated body, according to some embodiments of the invention.
  • 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.
  • 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
  • Figure 4q shows a schematic representation of the inflatable sleeve element 438 in an inflated configuration mounted on the elongated body 306.
  • 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.
  • FIG. 6a-6c showing schematic representation of exemplary means and method for assessing distances during the procedures, according to some embodiments of the invention.
  • 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.
  • 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.
  • FIGs 6a-6b showing schematic representations of laser triangulations, according to some embodiments of the invention.
  • FOV field of view
  • 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.
  • 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.
  • the user and/or the system 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.
  • multiple lasers positioned around the frontal camera 308 can be used.
  • the user and/or the system 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.
  • 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.
  • 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.
  • 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.
  • another option is to keep the laser ON until reaching the proper distance and then turn it off to improve image quality.
  • 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.
  • the GUI may comprise a digital screen, where visual cues are provided to the user.
  • the GUI does not comprise a digital screen and the GUI is just a User Interface (UI).
  • the GUI may comprise speakers configured to provide verbal instructions (see below) and/or indication sounds (like beeps).
  • 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.
  • 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.
  • 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.
  • 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).
  • verbal guiding for example instructions being provided via the one or more speakers
  • imaging guiding for example using a video shown in the GUI
  • visual guiding for example using lights that indicate either success or failure if a certain action.
  • 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.
  • FIG. 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
  • 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.
  • the external cameras are configured to have in their field of view the extending elongated body 306.
  • the user 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.
  • an exemplary method of calibration comprises an automatic identification of the external anatomical landmarks.
  • 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).
  • Al artificial intelligence
  • an exemplary method of calibration comprises a guided identification of the external anatomical landmarks.
  • 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.
  • the system automatically identifies the clitoris.
  • the system shows the identified clitoris to the user via the GUI and requests confirmation that the identified object is indeed the clitoris.
  • the system is configured to provide alternative external anatomical landmarks in case the automatic identification was not correct.
  • an exemplary method of performing external calibration comprises one or more of the following actions:
  • the system requests from the user to position the self-examination device 102 in front of the vaginal area (802).
  • the system receives confirmation from the user that the selfexamination device 102 is in front of the vaginal area (804).
  • the system 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).
  • the system utilizes all cameras, including the front camera 308, during the calibration process.
  • the user 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.
  • the system then analyzes the visual data (808).
  • the system automatically identifies one or more external anatomical landmarks (810).
  • 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).
  • 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.
  • the system assesses the input provided by the user, whether the automatic identification was correct (816).
  • 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.
  • 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).
  • the system receives the input from the user (824).
  • 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.
  • the system then assesses if the minimum number of external anatomical landmarks have been identified (826).
  • the system can begin the external examination procedure (see below) (830).
  • the system receives confirmation from the user that the first specific external anatomical landmark is being pointed out (834).
  • the system performs the action from 806 in Figure 8a forwards, until completion of the calibration process (836).
  • an exemplary method of performing external calibration comprises one or more of the following actions:
  • the user turns on the self-examination device 102 (902).
  • the user positions the self-examination device 102 in front of the vaginal area (904).
  • the user sends a confirmation that the self-examination device 102 is in front of the vaginal area (906).
  • the selfexamination device 102 succeeded in identifying at least one external anatomical landmark, or not.
  • the user receives a request to confirm an identified external anatomical landmark (908).
  • the user either confirms (910) or refutes (912) the identification of the external anatomical landmark.
  • the user receives a request to identify the identified external anatomical landmark (914).
  • the user provides a proper identification of the identified external anatomical landmark (916).
  • the user is then instructed to continue with the medical examination (see below) (918).
  • the user if the user confirmed the identification (910), then the user is instructed to continue with the medical examination (see below) (918).
  • the user receives a request to point out to a first specific external anatomical landmark (920).
  • the user points out to the first specific external anatomical landmark (922).
  • the user confirms to the self-examination device 102 using the GUI that the first specific external anatomical landmark is being point out (924).
  • the user is either instructed to continue with the medical examination 918 or the calibration process continues from action 908.
  • an internal calibration is performed.
  • the elongated body 306 of the self-examination device 102 is inserted within the bodily orifice, as schematically shown in Figures 10a- 10b.
  • 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.
  • FOV Field Of View
  • the acquisition of images/videos by the front camera 308 is performed at any time during the insertion of the elongated body 306.
  • 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.
  • 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).
  • 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.
  • 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.
  • the self-examination device 102 is used in order to allow an untrained user to perform gynecological self-examinations.
  • 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.).
  • the system is configured to allow an untrained user to perform each type of examination by providing the user with detailed instructions.
  • 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.
  • an exemplary external and/or internal examination comprises one or more of the following actions:
  • 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).
  • medical data is acquired using the one or more sensors.
  • 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).
  • the method comprises automatically saving the images and/or videos (medical data) in a memory and/or database (1106).
  • the method comprises automatically analyzing the images and/or videos (medical data) (1108).
  • the method comprises automatically identifying one or more attributes related to the external/internal anatomical landmarks based on said analysis (1110).
  • attributes are provided with a value (quantitative and/or qualitative) which is used for further analysis.
  • 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).
  • the method comprises automatically comparing the identified attributes with predetermined attributes (1112).
  • predetermined attributes are based on preliminary examinations performed on the same subject.
  • predetermined attributes are manually added and/or amended by a dedicated medical personnel (for example the gynecologist).
  • the method comprises automatically identifying a difference in the compared attributes according to a predetermined attribute threshold (1114).
  • 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.
  • 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.
  • 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
  • the method comprises automatically generating a preliminary diagnosis based on said identified differences in the compared attributes (1116).
  • 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.
  • the method comprises automatically sending the preliminary diagnosis, together with the relevant data, to dedicated medical personnel (1118).
  • an exemplary general method comprises one or more of the following actions:
  • 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.
  • 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.
  • the device itself provides the indication.
  • indications comprise one or more of lights, sounds, images on the electronic device.
  • 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.
  • 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.
  • a micro-switch in the device detects the pull and automatically deflates the balloon.
  • the balloon is deflated manually.
  • the system is configured to receive the medical data information, analyze it and provide a preliminary diagnosis.
  • the system utilizes Al enhancements to learn and improve the diagnostics capabilities of the system.
  • 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.
  • 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.
  • a user 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.
  • 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.
  • the system is configured to assess whether the user suffers from pelvic organ prolapse.
  • pelvic floor disorder 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).
  • POP pelvic organ prolapse
  • a “prolapse” is the slipping down or forward of a part or organ, often as a result of weakened or stretched connective tissue.
  • Pelvic Organ Prolapse examples 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 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.
  • 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.
  • vaginal Prolapse The vagina itself droops until it protrudes from the body.
  • 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.
  • 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.
  • 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.
  • the system is configured to collect relevant medical data in order to reveal whether the user is suffering from any of the abovementioned pelvic organ prolapses.
  • the system is configured to perform a pelvic organ prolapse assessment using the Pelvic Organ Prolapse Quantifications System (POP-Q).
  • POP-Q Pelvic Organ Prolapse Quantifications System
  • 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.
  • 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.
  • 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.
  • 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.
  • POP-Q assessment is performed by doing a plurality of measurements between preset anatomical landmarks.
  • 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.
  • 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.
  • 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.
  • the distances used by the system are one or more of:
  • DI 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.
  • a sensor 204 for example, an accelerometer
  • an exemplary method of performing a POP-Q assessment comprises one or more of the following actions:
  • 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.
  • 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.
  • the diagnosis is sent to a dedicated medical personnel for further evaluation and approval.
  • 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.
  • the distances used by the system are one or more of:
  • 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.
  • DI ’max DI.
  • 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.
  • the value of DI’ also equals the distance between the one or more external cameras 310a-b and the front camera 308.
  • the system is configured to know at any moment the actual value of DI’ while the telescopic elongated body 306 is being actuated.
  • a sensor 204 for example, an accelerometer
  • an exemplary method of performing a POP-Q assessment comprises one or more of the following actions:
  • 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).
  • 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.
  • the diagnosis is sent to a dedicated medical personnel for further evaluation and approval.
  • the internal pressure sensors are configured to be actuated during the insertion of the elongated body (either fixed length or variable length).
  • 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
  • the system is configured to assess whether the user is suffering from urinary incontinence.
  • 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.
  • both the cervix (internally) and the urethra (externally) are visualized at a same time.
  • an exemplary method of assessing urinary incontinence comprises one or more of the following actions:
  • the order of visualizations can change, first the urethra is visualized and then the cervix is visualized.
  • stances can be standing, sitting, squatting, laying down on the back and laying down on the side.
  • 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.
  • the one or more balloons will also serve as a platform to apply the pelvic physiotherapy and feedback to the patient.
  • compositions, 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.
  • a compound or “at least one compound” may include a plurality of compounds, including mixtures thereof.
  • 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.
  • 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.
  • the system is configured to receive the medical data information, analyze it and provide a preliminary diagnosis.
  • the system utilizes Al enhancements to learn and improve the diagnostics capabilities of the system.
  • 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.
  • 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.
  • 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).
  • CIN Cervical Intraepithelial Neoplasia
  • 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.

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Abstract

L'invention concerne des systèmes et des procédés pour réaliser soi-même des examens gynécologiques. Le système comprend un dispositif pour réaliser des auto-examens médicaux, ayant un corps allongé ayant une extrémité proximale et une extrémité distale ; l'extrémité distale étant configurée pour être insérée dans un orifice corporel d'un sujet ; un ou plusieurs dispositifs d'imagerie frontale situés à l'extrémité distale du corps allongé étant configurés pour obtenir un ou plusieurs images et/ou vidéos d'un environnement interne de l'orifice corporel du sujet ; et un ou plusieurs dispositifs d'imagerie externes situés sur une base et orientés vers le corps allongé étant configurés pour obtenir un ou plusieurs images et/ou vidéos d'un environnement externe de l'orifice corporel du sujet ; et un processeur comprenant des instructions pour guider le sujet par l'intermédiaire d'un processus d'auto-examen.
PCT/IL2024/051060 2023-11-08 2024-11-05 Système et procédés d'examens gynécologiques Pending WO2025099717A2 (fr)

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US2746450A (en) * 1954-10-27 1956-05-22 William T Lady Body cavity examining instrument
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US8503747B2 (en) * 2010-05-03 2013-08-06 Sti Medical Systems, Llc Image analysis for cervical neoplasia detection and diagnosis
US11805994B2 (en) * 2017-10-04 2023-11-07 Duke University Colposcopes, mammoscopes, and inserters having curved ends and associated methods
US20210161375A1 (en) * 2019-12-03 2021-06-03 Naser Omer Ali Digital Colposcope for Self-Examination
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