WO2017168421A2

WO2017168421A2 - Medical device to measure cervical effacement and dilation

Info

Publication number: WO2017168421A2
Application number: PCT/IL2017/050387
Authority: WO
Inventors: Ali Stern-Cohen; Eyal Teichman
Original assignee: Obsmart Ltd
Priority date: 2016-03-28
Filing date: 2017-03-28
Publication date: 2017-10-05
Also published as: WO2017168421A3

Abstract

According to some embodiments of the invention, there is provided a device for insertion, at least in part, into a vagina, comprising: a body shaped and sized for vaginal insertion; an imager contained within the body; a controller in communication with the imager, the controller programmed to analyze data received from the imager; and a tissue supporter coupled to the body, the tissue supporter expandable to push the vagina walls so as to create a line of sight from the imager to at least a portion of the cervix.

Description

MEDICAL DEVICE TO MEASURE CERVICAL EFFACEMENT AND DILATION

RELATED APPLICATION/S

This application claims the benefit of priority under 35 USC § 119(e) of U.S. Provisional Patent Application No. 62/290,957 filed 28 March 2016, 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 intra-vaginal examination, and, more particularly, but not exclusively, to measurement of cervical effacement and dilation.

This invention, in some embodiments thereof, is in the technical field of Obstetrics and Gynecology medical devices.

More particularly, the present invention in accordance with some embodiments thereof is in the field of cervical effacement and dilation measurement devices and methodologies.

During the late stages of pregnancy, changes in the connective tissue soften the cervix, indicating the initiation of labor. Physical transformations of the tissue include thinning (effacement) and opening (dilation) of the cervix. Generally, the onset of labor is defined as uterine contractions that bring about demonstrable effacement and dilation of the cervix. The indications of painful and frequent contractions accompanied by 3-4 centimeters or more of dilation is the most common method used in the United States and most western countries to admit pregnant women for labor.

Cervical dilation is also used to determine the different stages of active labor and can be a significant indicator for abnormalities. Currently, cervical effacement and dilation measurements are mainly performed manually, during vaginal examination. The significant role of effacement and dilation in the process of labor emphasizes the importance of accurate and consistent measurements.

US Publication number 20100016668 discloses: "The invention is a system for performing a routine vaginal examination. The examination is carried out using a medical imaging device that is optimally shaped to match the shape of the vaginal canal and comprises an imaging sensor, wide field of view optics, illumination means, electronic circuitry, and communication means. In addition a medical image and analysis (MIUA) unit comprising a processor and a dedicated MIUA algorithm is provided, either as part of the device or as a separate unit. The system is characterized in that the dedicated MIUA algorithm compares the acquired images to a predefined standard of quality and verifies that sufficient images of a predefined region of interest (ROI) have been obtained; saves the acquired images that meet the predefined standard and also show the ROI; and signals the user carrying out the examination when a sufficient number of images having sufficient image quality and taken at appropriate viewing angles of the area being examined have been acquired. The device and MIU A unit enable routine examination of the vagina to be carried out a any location by untrained persons, preferably by the woman herself in the privacy of her own home. The images acquired by the camera are transmitted to an authorized center where trained medical personnel view, analyze, and interpret them." (Abstract) SUMMARY OF THE INVENTION

According to an aspect of some embodiments of the invention, there is provided a device for insertion, at least in part, into a vagina, comprising: a body shaped and sized for vaginal insertion; an imager contained within the body; a controller in communication with the imager, the controller programmed to analyze data received from the imager; and a tissue supporter coupled to the body, the tissue supporter expandable to push the vagina walls so as to create a line of sight from the imager to at least a portion of the cervix.

In some embodiments, the tissue supporter is shaped and sized to fit within a vaginal applicator and to expand upon exiting the vaginal applicator.

In some embodiments, the tissue supporter comprises a conical configuration when expanded.

In some embodiments, the tissue supporter comprises a plurality of elongate ribs arranged to expand from a collapsed state to a conical configuration.

In some embodiments, an apex of the tissue supporter faces away from the cervix when the device is inserted into the vagina. In some embodiments, an apex of the tissue supporter faces towards the cervix when the device is inserted into the vagina.

In some embodiments, the apex is configured to collapse inwardly into a volume of the conical tissue supporter, causing a more proximal portion of the tissue supporter to protrude radially outwardly.

In some embodiments, the tissue supporter, when expanded, applies non-uniform pressure onto the walls of the vagina.

In some embodiments, the tissue supporter is shaped and sized for use in a pregnant woman's vagina.

In some embodiments, the tissue supporter is sized to expand to a maximal diameter large enough to space out the walls of the vagina an amount sufficient for obtaining a selected field of view and small enough so as not to damage surrounding tissue.

In some embodiments, the tissue supporter comprises one or more pressure sensors.

In some embodiments, at least one of expanding and collapsing of the tissue supporter is performed based on an indication obtained by the sensor.

In some embodiments, the controller is configured to automatically expand the tissue supporter when the apparatus is introduced to the vagina.

In some embodiments, the tissue supporter is inflatable.

In some embodiments, the tissue supporter comprises two spaced apart ring shaped balloons which expand to seal against the walls of the vagina.

In some embodiments, the tissue supporter comprises shape memory material. In some embodiments, the tissue supporter expands to a cylindrical configuration.

In some embodiments, the device further comprises an actuator coupled to the imager, the actuator configured for manipulating a position of the imager with respect to the body.

In some embodiments, the actuator comprises an elongated extension flexible enough to enable maneuvering of the imager.

In some embodiments, the actuator is configured to position the imager at a selected angle with respect to the cervical os. In some embodiments, the controller is configured to assess at least one of cervical dilation and effacement from an image acquired by the imager.

In some embodiments, the controller is programmed to generate an indication to a user based on the assessment.

In some embodiments, the controller comprises a communication module for transferring images and/or measurements to external devices, systems or databases.

In some embodiments, the communication module is configured to send and receive data from one or more of: a user, a healthcare institution, a healthcare provider.

In some embodiments, the communication module is configured to send and receive data from a cellular phone.

In some embodiments, the device comprises a cleaning mechanism including at least one sprayer directed towards the cervix, and wherein the controller is programmed to actuate cleaning if an acquired image is blurred.

In some embodiments, the imager is mounted on a ball and socket joint.

In some embodiments, a distal end of the body comprises an optical window comprising one or more lenses.

According to an aspect of some embodiments of the invention, there is provided a method for examining a cervix, comprising introducing an imager into the vagina of a pregnant woman in her third trimester; expanding a tissue supporter to push the walls of the vagina outwardly to an extent sufficient for enabling visual access to at least a portion of the cervix; acquiring at least one image; and analyzing the at least one image.

In some embodiments, analyzing comprises identifying at least a portion of the cervix in the image.

In some embodiments, identifying is carried out by a neural network modeling algorithm.

In some embodiments, analyzing comprises measuring cervical dilation.

In some embodiments, the method comprises assessing a diameter of the internal and/or external os to determine cervical dilation.

In some embodiments, the method further comprises calculating a dilation rate based on at least two images acquired over a period of time.

In some embodiments, analyzing comprises measuring cervical effacement. In some embodiments, the method comprises generating an indication to a user based on analyzing.

In some embodiments, the indication comprises advising a user to reach the hospital for labor.

In some embodiments, the indication comprises a usage plan advising the user to repeat measurements within a selected time interval.

In some embodiments, introducing comprises self-introducing.

In some embodiments, analyzing comprises determining if the image is blurred.

In some embodiments, the method comprises cleaning the cervix by irrigating with fluid if the image is blurred.

According to an aspect of some embodiments of the invention, there is provided a tissue supporter for the vaginal canal, the tissue supporter mounted on a body shaped and sized for insertion into the vagina, the tissue supporter comprising: an arrangement of elongated ribs, the ribs coupled to each other at their proximal ends and configured to expand from a collapsed configuration to an expanded configuration in which the ribs extend radially outwardly from each other to form a conical outer profile.

In some embodiments, the ribs comprise metal and/or plastic.

In some embodiments, the tissue supporter is configured to expand to a maximal diameter of 10 cm.

According to an aspect of some embodiments of the invention, there is provided a method of measuring an object from, comprising: acquiring a first image of the object using an intravaginal imager; moving the imager a known distance towards or away from the object; acquiring a second image of the object; and identifying the object in the images and determining a dimension of at least one feature of the object by comparing the images taking the known distance into account.

In some embodiments, the object is the cervix.

According to an aspect of some embodiments of the invention, there is provided a device for insertion, at least in part, into a vagina, comprising: a body shaped and sized for vaginal insertion; an imager contained within the body; a controller in communication with the imager, the controller programmed to analyze data received from the imager; and at least one fluid sprayer aimed distally; wherein the controller controls the sprayer so as to spray the cervix upon an indication of a blurred image acquired by the imager and analyzed by the controller.

In some embodiments, the device comprises a suction nozzle which sucks the fluid sprayed by the fluid sprayer.

According to an aspect of some embodiments of the invention, there is provided a method of monitoring fetal membranes, comprising: acquiring an image of a cervix including a fetal membrane; analyzing the image to identify the membrane; analyzing the image of the identified membrane to detect at least one of bulging and rupturing of the fetal membrane.

According to an aspect of some embodiments of the invention, there is provided a device for insertion, at least in part, into a vagina, comprising: an optical dome; a handle unit coupled to a proximal end of the optical dome; an inflatable annular element positioned at an interface between the handle unit and the optical dome; and a protective sheath extending proximally from the annular element, the sheath extendible over at least a portion of the handle unit.

In some embodiments, the optical dome is detachable from the handle unit and replaceable.

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.

Implementation of the method and/or system of embodiments of the invention can involve performing or completing selected tasks manually, automatically, or a combination thereof. Moreover, according to actual instrumentation and equipment of embodiments of the method and/or system of the invention, several selected tasks could be implemented by hardware, by software or by firmware or by a combination thereof using an operating system.

For example, hardware for performing selected tasks according to embodiments of the invention could be implemented as a chip or a circuit. As software, selected tasks according to 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 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.

BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWING(S)

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:

FIG. 1A is a is a flowchart of a method of acquiring an image of the cervix, according to some embodiments of the present invention;

FIG. IB is a schematic block diagram illustrating a method of operation of a Cervical Effacement and Dilation Measurement Device (CEDMD), according to some embodiments of the present invention;

FIGs. 1C, ID are block diagrams of a home use system (1C) and a hospital system (ID), according to some embodiments of the present invention;

FIG. IE is a flowchart of a method of self-using a device for acquiring an image of the cervix, according some embodiments of the invention;

FIGs. 2Ai-ii schematically illustrate a device for acquiring an image of the cervix, according to some embodiments of the present invention; FIG. 2B is a perspective view of an embodiment of a medical device according to some embodiments of the present invention;

FIGs. 3 A (i, ii) and 3B (i-iii) are perspective views of the portability and design of the imager according to some embodiments of the present invention;

FIGs. 4Ai-iii illustrate stages of moving and optionally supporting the vagina walls, according to some embodiments of the present invention;

FIG. 4B is a side view of a tissue supporter according to some embodiments of the present invention;

FIGs. 4C-J are exemplary configurations of tissue supporters, according to some embodiments of the present invention;

FIG. 5 is a perspective view of the cervical cleaning mechanism according to some embodiments of the present invention;

FIG. 6 is a perspective view of an embodiment of a wearable version of a medical device according to some embodiments of the present invention;

FIG. 7A is a schematic block diagram illustrating the software methodology of according to some embodiments of the present invention;

FIGs. 7Bi-ii are flowcharts of an image processing algorithm for processing an image of the cervix, according to some embodiments of the present invention;

FIG. 8 is a side view of effacement measurement methodology according to some embodiments of the present invention;

FIG.9 is a perspective view of the telemedicine wireless network according to some embodiments of the present invention;

FIG. 10 is a flowchart of a method of determining dilation rate and providing feedback to the user, according to some embodiments of the present invention; and FIG. 11 is an exemplary scheme for testing dilation rate and providing feedback to the user, according to some embodiments of the present invention;

FIG. 12 is an example of a device for imaging from within the vagina, according to some embodiments. DESCRIPTION OF SPECIFIC EMBODIMENTS OF THE INVENTION

A broad aspect of some embodiments relates to positioning a device comprising an imager in the vagina, at a position suitable for acquiring images of the cervix or portions thereof. In some embodiments, the device is self-inserted by a user. Optionally, the user is a near-term woman.

In some embodiments, at least a portion of the device is introduced to the vagina. Optionally, a portion of the device remains external to the body.

In some embodiments, the device portion entering the vagina is shaped and sized to advance a distance into the vagina, for example comprising an elongated form, such as a cylindrical body.

An aspect of some embodiments relates to a device for insertion into the vagina which comprises a tissue supporter structured to push and/or hold and/or otherwise space apart the walls of the vaginal canal, to an extent sufficient for creating a line of sight between the imager and at least a portion of the cervix, such as the external os. In some embodiments, the tissue supporter is configured to expand from a collapsed configuration in which it is introduced (optionally along with the rest of the device) into the vagina, to an expanded configuration in which it engages the walls of the vagina. In some embodiments, in the expanded configuration, the walls of the vagina are pushed sufficiently apart with respect to the device and/or with respect to each other so as to clear vision to the cervix and enable it to be within the imager's field of view. In some embodiments, the tissue supporter is configured to expand to a maximal diameter of, for example, 5 cm, 7 cm, 10 cm, 12 cm or intermediate, larger or smaller diameter.

The tissue supporter, in some embodiments, comprises a conical outer profile when expanded, with the apex of the cone facing away from the cervix, or, in other embodiments, facing towards the cervix. Alternatively, in some embodiments, the tissue supporter comprises a cylindrical outer profile when expanded. In some embodiments, the tissue supporter comprises a surface which prevents softened or collapsing vaginal wall tissue from entering the imager's field of view. Expansion mechanisms of the tissue supporter may include inflation, use of shape memory material, spring based actuation, self-expansion mechanisms, and/or others. In some embodiments, the tissue supporter expands when released from delivery means, such as an applicator.

A tissue supporter for example as described herein may be especially advantageous for pregnant women, especially near term women, in which the vaginal tissue tends to softens and collapse inwardly, interfering with visual access to the cervix.

In some embodiments, the tissue supporter, when expanded, is configured to apply radially outward force on at least a segment of the walls of the vaginal canal. In some embodiments, a force of, for example, between 100-200 gram-force is applied to the vagina wall. In some embodiments, the tissue supporter is inclined such that when pulled in the proximal direction, for example when the device is pulled out of the vagina, the tissue supporter collapses inwardly. Optionally, the tissue supporter self-collapses upon tugging on an external portion of the device. Self-collapsing of the tissue supporter may facilitate removal of the device out from the body and/or reduce damage to tissue coming in contact with the supporter when removed.

An aspect of some embodiments relates to measuring cervical dilation and/or effacement of a user, by imaging the user's cervix from within the vagina, and providing feedback to the user. Some embodiments relate to monitoring dilation rate and/or effacement and communicating the results and/or indications generated based on the results to the user herself, to a physician, to an external database or system (e.g. a hospital system) and/or other.

In some embodiments, parameters such as dilation, percentage of effacement, a length of the cervix, a consistency of the cervical tissue, and/or other are assessed from one or more images acquired by the device. Optionally, the device is configured to provide a Bishop score. In some embodiments, descent of the fetus head is assessed. In some embodiments, a fetal membrane and/or other portions of the amniotic sac are imaged, and their condition is assessed (for example, for indicating rupture of the membranes). In some embodiments, the one or more parameters are assessed by comparing an image to one or more previous images acquired by the device, and optionally stored on a device memory and/or external server or database. In some embodiments, images are acquired using optical means (such as using an image sensor and a lens). Additionally or alternatively, ultrasound means such as an ultrasound transducer are used. In some embodiments, the acquired images are processed by a controller of the device. Additionally or alternatively, the images are communicated to an external source such as a clinic computer, a physician, a service center, a hospital and/or other for processing.

In some embodiments, control of device operation is performed by the user, physician and/or other clinical personnel and/or performed automatically. Optionally, activation is performed via a dedicated cell phone application.

In some embodiments, based on one or more of the parameters assessed from the one or more images, one or more of the following indications are generated: a usage plan, a recommendation, an alert (e.g advising the user to reach the hospital for labor), and/or other indications. In an example, the usage plan includes a time window within which the next measurement should be obtained. Optionally, the usage plan is defined according to thresholds, for example, for dilation between 0 and 2.5 cm, the generated plan advises the user to measure again within a time period of, for example, 30 minutes. In another example, for dilation higher than 2.5 cm, the generated recommendation is to reach the hospital. In some embodiments, the usage plan and/or other user recommendations are generated according to the current values of the measurement (for example a current effacement percentage) and/or according to a trend indicated by two or more measurements, for example an increase in dilation rate. Optionally, the usage plan is adjusted in real time.

In some embodiments, the usage plan suggests timing and/or recommends which parameters should be assessed. In some embodiments, timing is determined according to one or more of: an expected time interval in which a change is expected to occur or to be observable in the measured parameter; a distance of the user from the hospital; a prediction of time left until labor (assessed for example based on previously measured parameters); and/or others. Optionally, a suggested time window is long enough so as to be able to observe change in the parameter. Optionally, a suggested time window is short enough so that a measured condition passes and is no longer relevant.

In some embodiments, static information is combined with dynamic information for generating an indication and/or usage plan. In an example, static information such as a current dilation is analyzed with respect to an intensity of an ongoing contraction, for example to determine if the contraction is "effective" in the sense that it has resulted in dilation.

In some embodiments, the measured parameters and/or generated indications and/or personal user data are communicated externally, for example to a hospital or other medical center, for example allowing the center to prepare in advance for arrival of the user.

An aspect of some embodiments relates to identifying objects and/or distances by changing a position of an imager with respect to an object. Optionally, relative distances and/or positions between two or more objects are assessed. In some embodiments, an imager positioned in the vagina is moved at quantified, predetermined steps with respect to the imaged object, for example the cervix. In some embodiments, a current location and/or advancement of the imager is indicated by a position sensor. Optionally, the position sensor is included within and/or mounted on the imager; additionally or alternatively, the position sensor is located apart from the imager. In some embodiments, one or images are acquired at each step. In some embodiments, the device comprises an accelerometer and/or gyroscope for indicating if and/or to what extent the device has moved during image acquisition. Optionally, such movement is taken into account during analysis of the image.

In some embodiments, for every pair of images acquired at a known distance from each other, an order of the object appearing in the image and whether it has increased or decreased is determined. The increasing or decreasing order is the difference of a pixel size between the first and the second images, measure, for example, by an optical flow algorithm which calculates the differences for either all pixels or a sub group of pixels representing the object itself. Optionally, based on the closed loop distance measurement algorithm for example as described herein, distances such as dilation (measured for example by assessing a diameter of the cervical os), a length of the cervix, and/or other parameters can be assessed.

In some embodiments, movement of tissue such as the cervix or vagina wall is taken into account. Optionally, movement of tissue is estimated by comparing images subsequent images. An aspect of some embodiments relates to a cervical cleaning mechanism actuated via closed loop feedback received from an imager positioned in the vagina. In some embodiments, a device for example as described herein comprises at least one sprayer positioned to irrigate the cervix. Optionally, irrigation is activated upon an indication from the imager and/or the device controller, for example if a blurred image is received.

An aspect of some embodiments relates to a cervical cleaning mechanism in which fluid is sucked back into the device. Optionally, sucking the fluid leaves the cervix dry. In some embodiments, following suction, an image of the cervix can be obtained without having the fluid interfere.

The present invention, according to some embodiments thereof, relates to a medical device to measure cervical effacement and dilation for home as well as hospital or clinical use. In some embodiments, the device includes internal and external chambers. In some embodiments, the internal chamber is covered by an inflating tissue supporter to allow visualization inside the vagina and comprises an imager at the distal end and optionally other apparatuses. In some embodiments, the external chamber encounters controller, actuator and optionally additional controlling components. In some embodiments, cervical dilation and effacement are assessed by image and/ or ultrasound analysis.

Devices and/or methods for example as described herein may be especially advantageous for pregnant women, such as women in their third trimester and/or near term women or even women during labor. A self inserted, self operated device may allow a user to assess her condition at her own home.

Methods and/or devices for example as described herein may be used for one or more of: prenatal examination, examination during labor, assessment of premature delivery, general vaginal examination, early detection of cervical cancer, and/or other applications.

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 the drawings: A method of acquiring an image of the cervix for assessment of cervical dilation and/or effacement

FIG. 1A is a flowchart of a method of acquiring an image of the cervix, according to some embodiments of the present invention.

In some embodiments, a decision is made to measure cervical effacement and/or dilation (101). In some embodiments, the decision is made by a physician and/or other clinical personnel. Additionally or alternatively, a self decision is made by a woman, optionally a pregnant woman. In some embodiments, the decision is made by and/or for a near- term pregnant woman.

In some embodiments, the method is performed at a clinical center or hospital.

Additionally or alternatively, the method is performed at home. Optionally, a user begins measuring at home, and continues measuring in the hospital when arriving for labor.

In some embodiments, the method is performed for monitoring pre-birth progress and/or for monitoring during birth.

In some embodiments, a device for imaging the cervix is introduced, at least in part, into the vagina (103). Optionally, the device is self-inserted by the user; additionally or alternatively, a physician or other clinical personnel inserts the device into position. In some embodiments, insertion is assisted by an applicator and/or other guiding element shaped and sized to direct at least a portion of the device into the vagina.

In some embodiments, self-insertion is performed when the woman is standing up, sitting, and/or lying on her back. Optionally, self-insertion is performed in a manner similar to insertion of a tampon.

In some embodiments, the device is a portable, hand-held device. In some embodiments, the device may come in kit form, including, for example, two or more replaceable portions for insertion into the vagina. Optionally, the insertable portions vary in shape and/or size, for example matching a different predicted shape and/or size of the vagina at various stages of pregnancy.

In some embodiments, at least a portion of the device is actuated to expand and/or automatically expands to move the walls of the vagina (e.g. push the walls aside) so as to create visual access to the cervix (105). In some cases, pregnancy may interfere with insertion and/or advancement of the device into the vagina, for example due to suffusion of fluid the walls of the vagina become softer and collapse more easily, and in order to insert the device the walls need be pushed apart or at least held supported. Other conditions that affect access through the vagina in pregnant women may include that the enlarged uterus presses against the vagina, narrowing down the opening, and/or large amounts of mucus that may interfere with access and/or imaging.

In some embodiments, once a line of sight to the cervix is obtained, one or more images are acquired (107). In some embodiments, images are obtained by a camera and/or other imager of the device. In some embodiments, the acquired image is processed (109), for example by applying image processing algorithms, pattern recognition algorithms, neural network modeling and/or other suitable algorithms to determine one or more of: cervical dilation, cervical effacement, cervical length (a length of the endocervical canal), Bishop score, contractions duration and/or intensity, fetal heart rate, and/or other parameters. In some embodiments, for obtaining the measurements, the cervix and/or other organs (e.g. uterus) are identified in the acquired image.

Optionally, if the image is blurred, cleaning is applied (108), for example using one or more sprayers that are mounted onto the device and which are suitable for irrigating the vagina and/or cervix.

In some embodiments, the measurement results are communicated (111) to the user and/or to clinical personnel and/or to a database (e.g. a hospital database). In some embodiments, the device communicates with a cell phone application, for example operated via the cell phone and/or sends data to the application. In some embodiments, the device communicates with a remote server.

In some embodiments, processing of the image is performed externally of the device. Optionally, an acquired image is sent to a physician and/or other clinician and/or service center for processing. In some embodiments, the device is configured for monitoring dilation and/or effacement and/or other parameters by remaining inside the body for relatively long periods of time, such as 15 minutes, 30 minutes, 1 hours, 3 hours, or intermediate, longer or shorter time periods. Optionally, measurements are acquired in a continuous manner. A potential advantage of continuous monitoring may include hospital monitoring of women who arrived to the hospital for labor but are not yet in active labor stages. Optionally, monitoring a current condition of women arriving for labor and communicating the results to a hospital database, system and/or clinical personnel enables managing and allocating of delivery rooms and/or staff to prevent overload, as the situation can be assessed ahead of time. In some embodiments, progression of early stages of labor is monitored. In some embodiments, pre-labor measurements (e.g. dilation) are analyzed with respect to progression during labor and/or to a time of giving birth; optionally, the relation between these is used for making predictions with respect to a same and/or different users to estimate timing.

FIG.1B is a schematic block diagram illustrating a method of operation of a

Cervical Effacement and Dilation Measurement Device (CEDMD) 10 (for example as shown in FIG. 2). In some embodiments, the tissue supporter 12 is inflated manually or automatically, optionally by a timing mechanism, mechanical operator and/or other means. In some embodiments, the tissue supporter 12 creates a space within the body to allow visualization. In some embodiments, the imager 14 moves automatically inside the internal chamber 16, back and forth, up and down, shooting images. In some embodiments, the controller 18 analyzes these images by applying algorithms. In some embodiments, the algorithms are programmed to find a target, to send a feedback signal 20 to control the movement of the imager 14, to measure the distance from the imager 14 to the object and to calculate cervical dilation. Additional programs may include closed feedback signal 20 for cleaning mechanism 22 and others. Cervical effacement is measured by image or ultrasonic signal analysis or mechanically.

FIGs. 1C, ID are block diagrams of a home use system (1C) and a hospital system (ID), according to some embodiments.

In FIG. 1C, an exemplary home use system is shown to include an intra-vaginal device for example as described herein. Optionally, the device communicates with a cell phone application. In some embodiments, the cell phone application receives data from the device (such as from the device controller) and/or the user. In some embodiments, the cell phone application receives and/or sends out instructions to the device (e.g. operation instructions) and/or indications or recommendations to the user. In some embodiments, the device communicates (receives and/or sends data) to a physician.

Optionally, communication between the device and the user is direct, for example via a screen configured on an external portion of the device.

In some embodiments, the home use device and/or cell phone application remotely communicate with one or more of a hospital system, an external server/database, a healthcare clinic and/or other. Optionally, the communicated data allows a hospital to monitor traffic into the delivery room, for example to prepare for arrival of a user.

In some embodiments, the home use device is a hand held, portable device. Optionally, the device is battery operated.

In FIG. ID, an exemplary system for use in hospitals is shown. Optionally, the device is used for continuously monitoring a user at pre-birth stages and/or during initial stages of labor. Optionally, a device for hospital use comprises a more durable design suitable for multiple uses and/or for use by multiple patients. In some embodiments, the intra vaginal hospital use device communicates with one or more of: a physician and/or other clinical staff, a delivery room nurse, an external server or database, the hospital monitoring system.

FIG. IE is a flowchart of a method of self-using a device for acquiring an image of the cervix, according some embodiments of the invention.

In some embodiments, a user, such as a pregnant woman in her third trimester, decides to use a device for example as described herein (171). Optionally, the user decides to use the device when feeling contractions, when her due date is close by, and/or upon her will. Additionally or alternatively, a user is instructed by a physician and/or other medical personnel to use the device.

In some embodiments, the device is removed from its package (173) and self- inserted by the user into the vagina (175). Optionally, feedback is provided to the user as to whether the device has been positioned properly.

In some embodiments, one or more images are acquired by the device (177), automatically and/or upon instructions received from the user and/or physician, for example via a dedicated cell phone application in communication with the device controller.

In some embodiments, parameters such as dilation, dilation rate, effacement percentage, a length of the cervix, contraction intensity, a condition of the fetal membranes and/or other parameters are assessed by the device by analyzing the one or more images.

In some embodiments, feedback is provided to the user based on the results of the measured parameters (179). Optionally, the feedback comprises one or more of: the measurement results, the images acquired, indications and/or recommendations to the user that are generated based on the results, for example a recommendation to reach the hospital.

In some embodiments, following use, the user removes the device from the body. Alternatively, the user leaves the device inside for performing additional measurements and/or for continuous monitoring over a selected time period, such as 15 minutes, 30 minutes, 1 hour, 4 hours or intermediate, longer or shorter time periods.

Optionally, once the device is removed from the body, it can be washed clean. Additionally or alternatively, at least a portion of the device is disposable and is discarded. Additionally or alternatively, the device is protected by a disposable sheath which is removed and discarded. Optionally, a portion of the device such as the portion being inserted into the vagina is replaced by a new one before the next use.

In some embodiments, the device stores the images and/or measurement results on a memory, and/or communicates these results to a user interface such as the cell phone application. Optionally, the user takes the device along with the data stored on it to the hospital when arriving for labor. A device for acquiring an image of the cervix for assessment of cervical dilation and/or effacement

FIG. 2Ai-ii schematically illustrate, at a longitudinal cross section, a device for acquiring an image of the cervix for assessment of cervical dilation and/or effacement, according to some embodiments of the present invention. In some embodiments, device 201 includes a first portion 203 that is inserted, at least in part, into the vagina; and a second portion 205 that remains outside the body. (In some of the embodiments describe herein, first portion 203 may be referred to as an "internal unit"; and second portion 205 may be referred to as an "external unit").

Alternatively, in some embodiments, the device is configured to be inserted into the body in its entirety. Optionally, a string, cable, or other extension extend from the device to the external genitalia. In some embodiments, the extension comprises an antenna or other means suitable for communicating data received by the device to external devices, systems, or databases.

In some embodiments, the device comprises a tissue supporter 219 which is configured to expanded from a closed, collapsed configuration for example as shown in FIG. 2Ai to an open, expanded form for example as shown in FIG. 2Aii. In some embodiments, the device is introduced to the vagina when tissue supporter 219 is in the closed configuration, and once the device is advanced a sufficient distance, for example up to 5 cm, up to 3 cm, up to 2.5 cm or intermediate, longer or shorter distances relative to the external genitalia, expansion is actuated so as to push the internal walls of the vagina and space them apart. In some embodiments, tissue supporter 219 is inflatable. In some embodiments, tissue supporter 219 is mechanically actuated to expand, for example using an energy storage element (e.g. spring), shape memory element, elastic material which expands when released, a mechanical arm and/or other expanding mechanism.

In some embodiments, first portion 203 is shaped and sized to be introduced and optionally advanced through the vagina. In some embodiments, portion 203 comprises a substantially cylindrical outer profile. Optionally, portion 203 houses additional cylinders that can telescopically extend in the distal direction.

In some embodiments, in the expanded form of the tissue supporter 219 for example as shown in figure 2Aii, a distal end segment of the supporter expands radially outwardly, setting a substantially conical configuration, for example as shown in figure 2Aii. In some embodiments, the walls of tissue supporter are pushed apart from each other, for example until an angle a which is between, for example, 20-60 degrees, such as 30 degrees, 40 degrees, 50 degrees or intermediate, larger or smaller angles is formed with respect to a long axis 207 extending between a proximal end and a distal end of device 201.

In some embodiments, first portion 203 comprises an imager 209. In some embodiments, imager 209 comprises a sensor, illuminator, one or more lenses and/or other optical means.

In some embodiments, the imager's field of view 231 (which can also be referred to as the angular extent of the scene covered) ranges between 0-180 degrees, such as 30 degrees, 60 degrees, 90 degrees, 120 degrees, or intermediate, larger or smaller angles. Optionally, the imager is configured to capture an object at a distance of between, for example, 0.3 mm to 20 cm or intermediate, longer or shorter distances from the imager.

In some embodiments, first portion 203 comprises more than one imager, for example 2, 3, 5, 7, 10 or intermediate, larger or smaller number of imagers. Optionally, the imagers are arranged to cover a selected field of view, for example, a plurality of imagers may be arranged to obtain a stereoscopic view. In an example, a plurality of imagers are arranged to obtain a 360 degree view.

In some embodiments, imager 209 is mounted on a moveable actuator 211. Optionally, actuator 211 can be moved along the device long axis 207 (e.g. between the proximal and distal ends) and/or moved width-wise (along axis 217), for example so as to obtain a desired viewing angle.

In some embodiments, the imager is moveable in a pattern selected for obtaining an image in which a certain organ or parts thereof can be observed, and/or for enabling measurement of certain parameters. For example, imager 209 can be moved back and forth along a section of long axis 207, for example advanced distally to obtain an image of the internal os and retracted proximally to obtain an image of the internal os. Optionally, cervical length is calculated based on the acquired images and optionally according to the extent of movement of the imager. In some embodiments, movement of the imager is automatically actuated by the controller. Additionally or alternatively, movement of the imager is controlled by a physician, optionally remotely. In some embodiments, imager movement is carried out by a motor.

In some embodiments, second portion 205 is shaped and sized to remain outside the body, for example shaped to abut against the external walls of the vagina. Optionally, second portion 205 comprises a widening profile, increasing in the proximal direction. In some embodiments, second portion 205 houses circuitry for operating the device and/or for communicating with other modules, for example including a controller 213, powering means 215 (e.g. a battery), and/or other components associated with device operation. Optionally, second portion 205 comprises a screen for displaying measurement results and/or operation status.

In some embodiments, during insertion of first portion 203 into the vagina, advancement is stopped manually (such as when a user senses resistance when reaching an end of the vagina) and/or automatically. Optionally, advancement is stopped when pressure above a certain level is sensed, for example sensed automatically by a pressure sensor mounted onto a distal end 241 of portion 203. Additionally or alternatively, advancement is stopped according to optical recognition of an organ or portion thereof, for example when the cervix or end of vagina are identified in an image acquired by the imager. In some embodiments, the imager is advanced distally of distal end 241.

In some embodiments, portion 203 is advanced distally within the vagina until an opening of the cervix can be visualized. Optionally, portion 203 is advanced further in the vagina, for example until the internal os and/or the lower part of the uterus can be visualized. In some embodiments, the head of the fetus is identified in the image. Optionally, the head of the fetus is identified only once the cervix has dilated enough to enable visual access to the head of the fetus.

In some embodiments, manipulation of imager 209 to obtain a selected field of view is performed manually, for example by controlling actuator 211, such as from outside the body. Additionally or alternatively, movement of imager is actuated autonomously, for example via controller 213.

While a CEDMD device for example as described hereinabove may be used both at home and at the clinic or hospital, a device designed for extensive use (such as in hospitals) may include a durable, rigid design, suitable for long term monitoring. Optionally, the device will include a wired connection. In some embodiments, a controller of a device suitable for hospital use will be programmed to carry out calculation of bishop score; calculate, based on the acquired images, a position of the cervix; measure tissue consistency using a sensor and/or chemical test; employ ultrasound, for example for assessing effacement; assess dilation; monitor contractions and indicate trends; and/or other functions. In some embodiments, contractions are analyzed in the context of dilation- for example, based on change in dilation in response to contraction, the device can indicate if the contraction was effective or not. Optionally, in a situation in which contractions are present but dilation does not progress, the device may generate an alert.

In some embodiments, a fetal membrane and/or other portions of the amniotic sac are imaged. Optionally, the imager is advanced towards the cervical os, and one or more images are acquired. During analyzing of the image, one or more algorithms suitable for identifying the fetal membrane may be applied. In some embodiments, the applied algorithm comprises a segmentation algorithm which is based on color and texture. Optionally, a shape and/or position of the fetal membrane are assessed. Optionally, an assessment is made whether the membrane is still intact, the membrane has ruptured (for example following breaking of the amniotic sac), the membrane bulges outwardly and/or other conditions. In some embodiments, an indication to the user is generated based on the fetal membrane assessment. In an example, a fetal membrane that bulges outwardly from the cervix during early stages of pregnancy may indicate preterm labor, in which case an indication will be generated by the system and provided to the user. Use of the device as an indicator of fetal membrane condition may reduce the need for a chemical pad which indicates amniotic leakage, as the condition of the fetal membranes can be directly assessed.

In some embodiments, devices and/or methods for example as described herein are used for early detection of cervical cancer. In some embodiments, the acquired images are analyzed for the presence of acetowhite areas (whitening of tissue) in the cervix, which may be indicative of early cervical cancer. In some cases, the shape of these areas and their relative location to orifice of cervix (OS) is important in determining whether there is concern for the development of cervical cancer. In some embodiments, the acetowhite areas are identified in the image with respect to the external and/or internal os. Optionally, an algorithm is applied to divide an acquired image into regions segmented according to the variations in color and/or location. Optionally, machine learning algorithms (e.g. Neural network modeling, SVM) are used for identifying the relevant areas. In some embodiments, a shape and/or size of the acetowhite areas and/or their location with respect to the OS are assessed. In some embodiments, the obtained parameters are compared (optionally using machine learning techniques) to prevalent cervical cancer indications to determine whether the user is healthy, at risk, or already suffering from cancer or pre-cancer stages.

The medical device in FIG. 2B describes a Cervical Effacement and Dilation measurement Device (CEDMD) 10, in accordance with some embodiments. In some embodiments, the distal end of the CEDMD 10 includes an external chamber 24 connected to an internal chamber 16 at the proximal end. In some embodiments, the external chamber 24 which contains operational features (for example as detailed below) communicates with the remote device 26 and/or with the controller 18 which is either located within the external chamber 24 or distant. Features that are incorporated in various embodiments of the CEDMD 10 of the present invention may include, but are not limited to, a tissue supporter 12, an imager 14, an actuator 28 and a lens 30. In some embodiments, the remote device 26 may include an external controller 18 to analyze the data, control buttons 32 and a displayer 34 for the results.

In some embodiments, features within the external chamber 24 include regulating the movement of the imager 14 and tissue supporter 12 as well as inflating the tissue supporter 12. In some embodiments, the controller 18 assesses image and/or ultrasound signals to measure cervical effacements and dilations. In some embodiments, the image signals are captured while the imager 14 is in motion inside the vagina 36, until it focuses on the target. In some cases, the size of the opening of the target indicates cervical dilation. In some embodiments, cervical effacement measures the length of the cervix 116 either with an imager 14 imaging through the OS or with an ultrasonic method.

In some embodiments, the controller 18 may be located within the external chamber 24 where it communicates wirelessly the output data to the remote device 26 or within the remote device 26, where it wirelessly receives the input data and may also communicate the output data to additional devices. In some embodiments, if required, the control button 30 on the remote device 26 may control mechanisms such as initiation and termination of the CEDMD functions. In some embodiments, the tissue supporter 12 gently pushes the internal vaginal tissue to create space thereby clearing visualization. Additional features of the tissue supporter 12, in accordance with some embodiments, include flexibility to allow the lens 30 at the proximal end move, while the distal end stabilizes the internal chamber 16. In some embodiments, the actuator 28 electronically controls and moves mechanisms such as the imager 14.

In further detail, still referring to the example of Fig. 2B, in some embodiments the internal chamber 14 of the CEDMD 10 is sufficiently short and thin to enter the vagina 36 comfortably, such as about 2 to 6 centimeters long and about 1 to about 2 centimeters in outer diameter, when the tissue supporter 12 is not inflated. In some embodiments, the size of the external chamber 24, such as, roughly up to 2 centimeters deep and roughly up to 20 centimeters wide, is suitable to simultaneously contain control features and possibly display results, while preventing load on the internal chamber 16. In some embodiments, the tissue supporter 12 inflates optimally for the comfort of the user 124 (see for example FIG. 9) while creating a lumen 40, for instance, approximately, 30 2 to 5 centimeters.

Further, in some embodiments, the Cervical Effacement and Dilation Measurement Device (CEDMD) 10 should compose biocompatible materials and sterilize according to required medical grade standards. In some embodiments, the external chamber 24 includes a combination of sufficiently rigid and strong materials such as metal, glass, high strength plastic and the like. In some embodiments, the tissue supporter 12 should be made of a biocompatible strong and flexible material that may be disposable such as plastic polymers for example PVC and PET or nylon. In some embodiments, the tissue supporter 12 may be coated for lubrication, for abrasion resistance or other reasons.

FIG. 3Ai-ii describe the movability of the imager 14, in accordance with some embodiments. Particularly, FIG. 3Ai presents one such possibility in which a flexible tip 38 at the distal end of the lumen 40 performs the movement, in accordance with some embodiments. In some embodiments, the locomotion of the imager 14 occurs either manually or automatically. In some embodiments, a handle 42 located within an external chamber 24 is utilized to control the imager 14 manually and the actuator 28 controls electronically the imager 14 via electric wire 44 running from the actuator 28 through the lumen 40 to the flexible tip 38. FIG. 3Aii presents yet another possibility for locomotion of the imager 14, in the form of ball and socket 46, according to some embodiments. In some embodiments, the imager 14 is attached to a ball 46a shaped particle placed within a socket 48b in the shape of a semi-circle with a larger radius then the 20 ball 46a just so that the ball 46a is held within the sock 48b but allows movement. In some embodiments, the actuator 28 electronically controls the movement of the ball and socket 46 and imager 14 via an electric wire 44 connected on one side to the actuator 28 and on the other side to the ball 46a, running through the lumen 40. In some embodiments, the tissue supporter 12 inflates to hold the tissue in a manner that forms space and allows visualization. In some embodiments, the imager 14, among other components, consists an image sensor 48, illuminator 50 and a lens 30. FIGS 3Bi- iii present different possible sizes of lens 30 and optional distances between the image sensor 48 and the lens 30, according to some embodiments. In some embodiments, the lens 30 could be small and distant from the image sensor 48, for example as shown in FIG.3Bi or large, and distant from the image sensor 48, for example as presented in FIG.3BU or small and attached to the image sensor 48 for example as seen in FIG.3iii or additional combinations. In some embodiments, for example as shown in Fig. 3Bi the lens connector 52 connects the lens 30 to the image sensor 48 and moves the lens 30 in the same direction as the image sensor 48.

In some embodiments, the degrees of freedom and range of motion of the CEDMD 10 depend on the optical properties of the imager 14 (mainly focal length, depth of view and field of view). In some embodiments, the range of motion of the imager 14 is in the range of 0-180 degrees in each direction. In some embodiments, the axial movement of the imager 14 ranges within the distance between the distal end of the CEDMD 10 and the external OS 54 and depends on the optical properties of the imager 14. In some embodiments, the axial movement is in the range of 0-lOcm. In some embodiments, the size of the external chamber 24, such as, roughly up to 2 centimeters deep and roughly up to 20 centimeters wide, is suitable to simultaneously contain control features and possibly display results, while preventing load on the internal chamber 16. In some embodiments, the lumen 40 encompasses electric wire 44 transferring electrical current and data between the external chamber 24 components and internal chamber 16 components. Therefore, in some embodiments, the lumen 40 should be long enough to run from the external chamber 24 through the internal chamber 16, varying from 0-lOcm. It should be hollow and small as possible in radius. In some embodiments, the actuator 28 and controller 18 should be small enough to fit inside the external chamber 24. In some embodiments, the controller 18 may be a system on a chip. In some embodiments, the lens 30 connectors should be flexible yet strong enough to hold the lens 30 and move it in parallel to the image sensor 48. In some embodiments, the detached large lens 30 is a wide-angle lens 30, such as fish-eye, or other lenses that cover wide angles such as horizon to horizon views.

In some embodiments, the imager 14 comprises an image sensor 48, such as

CMOS, CCDs, EMCCD or others. In addition, in some embodiments, the imager comprises a reusable, or disposable, embedded, non-heating illuminator 50, such as LED. In some embodiments, the flexible tip 38 requires accurate and controlled movement; therefore, the flexible tip 38 should compose of materials such as plastic and or different polymers. In some embodiments, the tissue supporter 12 should be made of a biocompatible strong and flexible material that may be disposable such as plastic polymers for example PVC and PET or nylon. In some embodiments, the tissue supporter 12 may be coated for lubrication, for abrasion resistance or other reasons. In some embodiments, due to the continuous movement of the ball and socket 46, it should preferably include a strong material with low friction or lubricated material to prevent fatigue, such as coated metal or strong polymer. In some embodiments, the electric wire 44 should be composed of metal such as aluminum or copper. In some embodiments, the handle 42 used to manually move the flexible tip 38 requires strong and rigid material such as metal or strong polymers or other materials. In some embodiments, the functionality of the actuator 28 requires that it be made of flexible and durable material with high strain capabilities, such as, macro fiber composite (MFC), piezo ceramic material, conducting polymers or other materials. In some embodiments, the lens 30 may be made of coated glass, plastic, smart polymers or other materials. In some embodiments, the design of the CEDMED requires the lens 30 to be either disposable or non-disposable.

Tissue supporter

FIGs. 4Ai-iii schematically illustrate stages of moving and optionally supporting the vagina walls, according to some embodiments of the present invention. In some embodiments, tissue supporter 401 is expanded, optionally gradually, from a collapsed configuration for example as shown in figure 4Ai to an expanded configuration for example as shown in figure 4Aiii, applying pressure 405 onto the walls of the vagina 403 which pushes the walls apart from each other.

In some embodiments, pressure 405 is gradually increased, potentially reducing damage to the tissue.

In some embodiments, the vagina walls 403 are pushed until visual access to the cervix 407 is enabled, such as until a line of sight 421 is obtained between at least a portion of the cervix 407 and the imager 423. Optionally, the vagina walls are moved until at least the external os 409 is visible to the imager. Additionally or alternatively, the vagina walls are moved until the internal os and/or other portions of the cervix are detected. In some embodiments, the vagina walls are pushed enough so as to enable positioning imager 423 at a position in which a selected viewing angle β is obtained.

In some embodiments, tissue supporter 401 expands to a configuration that is substantially conical in cross section, pushing the vagina walls in a similar manner. Alternatively, tissue supporter 401 expands in a uniform manner, for example expanding to a substantially cylindrical configuration.

In some embodiments, the applied pressure is non-uniform along a long axis of the vagina. For example, a higher pressure may be applied to more distant segment of the vagina (e.g. a segment closer to the cervix) than pressure applied to a more proximal segment. Alternatively, the applied pressure is homogenous along the length of the vagina.

In some embodiments, the applied pressure is symmetrical, for example so that opposite walls of the vagina are equally spaced apart. Alternatively, the applied pressure is asymmetrical, for example pushing a vagina wall a greater distance than an opposing vagina wall. It is noted that for simplicity, a cross section along the length of the vagina is referred to herein, while in actual use a three dimensional, circumferential lumen is affected.

In some embodiments, tissue supporter 401 is configured to self-expand from its collapsed configuration, for example upon releasing of the tissue supporter from delivery means (not shown herein). Additionally or alternatively, expansion is actuated by a user and/or automatically actuated.

Various examples of a self expanding tissue supporter may include a spring actuated tissue supporter; an elastic tissue supporter which returns to an expanded form upon being released from delivery means; shape memory tissue supporter which, for example, in response to a temperature change (e.g. when placed in the vagina) deforms or returns into an expanded form.

Some potential advantages of a self -expanding tissue supporter may include: minimizing a size (e.g. diameter) of the CEDMD device, since the tissue supporter can be delivered in a collapsed form. This may be especially for pregnant women who are in pain due to contractions and may find it hard to self-insert a larger device into the vagina. The self-expanding tissue supporter may provide increased resistance against collapsing of the vagina walls, a condition which is common in near-term women.

Various examples of a tissue supporter may include an inflatable tissue supporter, a tissue supporter expandable by push/pull means, a tissue supporter which deforms when inserted into the body and/or when it is pushed against tissue, for example against the end of the vagina.

In some embodiments, the tissue supporter is configured to be actuated from outside the body, for example in response to pulling a string or cable.

In some embodiments, once the imager has been positioned at a location in which visual access to the cervix is obtained, it may be possible to remove the tissue supporter out from the body, while the imager (and optionally an actuator for controlling manipulation thereof) remains in place. This embodiment may be especially advantageous for pregnant women who may fear from rupturing of membranes upon insertion of the CEDMD device.

FIG.4B shows two axially spaced apart ring shaped balloons including the proximal ring balloon 56 and distal ring balloon 58, which are connected by a flexible connector 60, in accordance with some embodiments. Optionally, both balloon rings are in the frontal part of the tissue supporter 12. In addition, in some embodiments, the tip of the frontal tissue supporter 62 is the lens 30. In some embodiments, the posterior tissue supporter 64 is attached to the external chamber 24. In some embodiments, the air pump 66 is located inside the external chamber 24 and supplies air through the air tube 68 and the inflation valve 70 to inflate the tissue supporter 12 once inside the vagina 36.

In some embodiments, when the internal chamber 16 is placed within the vagina

36, either the user 122 (see for example FIG. 9) presses control buttons 32 or the expansion of the tissue supporter 12 is automatically initiated. Optionally, the air pump 66 pushes fluid through the hollow air tube 68 and the inflation valve 70 inflate the tissue supporter 12 including both posterior tissue supporter 64 and frontal tissue supporter 62. In some embodiments, the inflation valve 70, controlled mechanically or by an electrical actuator 28, allows air to flow only in one direction, and closes once the 25 tissue supporter 12 reaches a certain pressure. Optionally, the inflation valve 70 also ensures the pressure remains constant. In some embodiments, when required, the inflation valve 70 allows air to flow in the other direction and the tissue supporter 12 to deflate. In some embodiments, the tissue supporter 12 seals against said vagina 36 wall to form space for clear visualization of the image and for stabilization.

In some embodiments, the distal ring balloon 58 and proximal ring balloon 56 are two axially 30 spaced apart ring shaped balloons allowing stabilization and mechanical compliance. Optionally, a flexible connector 60 attaches the distal ring balloon 58 and proximal ring balloon 56. In some embodiments, the flexible connector 60, driven by a wire or actuator 28 or other means, allows flexibility and movement of the frontal tissue supporter 62. In some embodiments, the proximal end of the frontal tissue supporter 62 comprises the lens 30, which allows visualization of the image target.

In some embodiments, the functionality of the tissue supporter 12 requires that it be made of a flexible yet strong disposable material such as biocompatible silicone, rubber, plastic, or other polymers. In some embodiments, the proximal ring balloon 56 and distal ring balloon 58 maintain stability and therefore necessitate a strong and inflatable material such as biocompatible silicone, rubber, plastic, or other polymers. In some embodiments, the air pump 66 may be made of metal alloys and/or other such strong materials. In some embodiments, the cylindrical air tube 68 includes plastic and/or other materials, and optionally so does the inflation valve 70. In some embodiments, the functionality of the flexible connector 60 requires flexibility to allow movement of the embodiment and strength to withstand the air pressure. Consequently, in some embodiments, the flexible connector 60 requires it be made of materials such as biocompatible silicone, rubber, plastic, or other polymers. In some embodiments, the lens 30 may be made of glass, plastic, smart polymers or others.

FIGs.4C-J are exemplary configurations of tissue supporters, according to some embodiments of the present invention. FIG. 4C illustrates a cup shaped tissue supporter 431. Optionally, the cup is configured to be collapsed within delivery means (for example within a housing of a device for example as described herein, a delivery tube, and the like) and to expand upon releasing of the cup, for example by retraction of the delivery means and/or advancement of the cup distally outwardly from the delivery means. In some embodiments, an imager 451 is positioned within a lumen defined by the tissue supporter.

FIGs. 4D-G are examples of conical tissue supporters comprising an expandable infrastructure, according to some embodiments. In some embodiments, the infrastructure comprises a plurality of ribs 433 arranged to expand from a linear, collapsed state to a deployed expanded state. In some embodiments, for example as shown in figures 4D, E, ribs 433 are formed of plastic or polymer; additionally or alternatively, for example as shown in figures 4F-G (showing the tissue supporter alone and the tissue supporter mounted on its manufacturing jig), the ribs are formed of metal or metal alloy.

A potential advantage of a tissue supporter comprising a conical profile may include that expansion of the cone from a collapsed to an open configuration applies pressure onto the vagina walls in a manner that efficiently produces a space suitable for visualizing the cervix. In some embodiments, the wide base portion of the cone applies higher forces onto more distal portions of the vagina, for example as compared to forces applied by the narrower portion of the cone onto the vagina. In this manner, the tissue supporter applies non-uniform force onto the vagina walls, along the length of the vagina. A potential advantage of such conical configuration may include minimizing the application of force required for moving vagina tissue away from the line of sight to the cervix.

FIG. 4H is another example of a tissue supporter in a collapsed configuration, according to some embodiments;

FIGs. 4I-J illustrate a tissue supporter 435 which collapses, upon applying of pressure, into a configuration in which it pushes the walls of the vagina.

In some embodiments, tissue supporter 435 is introduced into the vagina such that apex 441 of the cone is inserted first and advanced into the vagina. Such configuration may facilitate insertion, as the widening profile of the tissue supporter is introduced gradually, and may be especially advantageous for near term women.

Optionally, the wide base portion of the cone remains outside the body.

In some embodiments, upon advancement of tissue supporter 435 in the vagina, apex 441 encounters pressure when contacting the end of the vagina and in response collapses into the cone, for example to a configuration as shown in FIG. 4J. In some embodiments, in the collapsed configuration, the walls of the cone move radially outwardly such that they apply a higher pushing force onto the walls of the vagina, distancing the walls apart.

In some embodiments, tissue supporter comprises one or more sensors 437.

Optionally, the tissue supporter apex is configured to automatically collapse, thus forming an expanded configuration, in response to the indications received from the one or more sensors 437.

In some embodiments, sensors 437 comprise pressure sensors. Optionally, actuation of collapsing is performed when an indication of pressure above or below a certain threshold is detected. In an example, pressure above a certain threshold indicates that the device was inserted into the body and/or that the device was advanced to the end of the vagina, and/or other position-related indications. In response to the indications, the tissue supporter is reshaped.

In some embodiments, sensors 437 comprise temperature sensors. Optionally, a detected rise in temperature indicates that the device has been inserted into the body, and so tissue supporter 435 may be expanded to space out the vagina walls.

Cleaning mechanism

FIG. 5 shows the automatic and optionally self-contained cervical cleaning mechanism 22, according to some embodiments. In some embodiments, the leading end of the device includes one or more sprayers 72, which aim forward at cervix 116 (and/or onto leading end of device) and clean them off. In some embodiments, a cleaning mechanism pump 74 applies suction through the cleaning mechanism tube 78 to clean away the sprayed fluid and any washed away material. In some embodiments, cleaning is optional. In some embodiments, cleaning is applied automatically and utilizes image processing for feedback. Optionally, when a feedback signal 20 from the imager 14 to the actuator 28 indicates that cleaning the cervix 116 is required, the cleaning mechanism 22 initiates. Optionally, at that point, the cleaning mechanism pump 74 drives fluid such as saline from an internal or external fluid reservoir 76 through the cleaning mechanism tube 78 to at least one of the fluid sprayers 72 aimed distally and/or at least one fluid sprayer aimed at the lens 30. Optionally, an actuator 28 controls the extent of time of fluid spraying and the repetition. In some embodiments, simultaneously and/ or following fluid spraying, an additional and/or the same cleaning mechanism pump 74, connected to suction nozzle 80 through an additional and/or the same cleaning mechanism tube 78 will suck the fluid in the other direction, thereby removing secretion from the target area to an internal or external secretion reservoir 82. Optionally, this process repeats until a positive feedback signal 20 arrives from the controller 16 or until it reaches a preset threshold or until halted by the user 124 (see for example FIG. 9). The number and location of the fluid sprayers 72 and suction nozzle 80 may vary.

In some embodiments, the cleaning mechanism tube 78 should be in the range of

6 to 10 cm long, to carry fluid from the external unit 24 to the frontal end of the CEDMD 10 and should be narrow to fit within the device diameter of 2 cm along with the lumen 40 and other tubes. In some embodiments, the cleaning mechanism tube 78 should be resilient and stable and therefore be made of material or strong plastic or polymers or other such materials. The cleaning mechanism pump 74 and reservoirs should be in the size to fit in the external unit 24 along with additional components. Optionally, the functionality of the cleaning mechanism pump 74 require it be made of a strong and tough material to be able to maintain a certain pressure and stability, such materials may include metal alloys or metals. In some embodiments, the fluid reservoir 76 contains fluid within the external unit 24, therefore is requires to be a strong material and yet stiff or flexible, such as metal, tough plastic or soft plastic, silicon, some polymers, rubber and other such materials. It may also be disposable. Optionally, the cleaning mechanism tube 78 is strong and tough. In some embodiments, the sprayers 72 and suction nozzle 80 are exposed to the vaginal environment, and should be light- weighted, therefore they require biocompatible material that withstands the vaginal environment acidity and can be sterilized, such as polymers, coated metal or other such materials. In addition, the sprayers 72 and suction nozzle 80 may also be disposable. Optionally, the functionality of the lens 30 and it's exposure to vaginal environment, requires it be made of materials such as glass, plastic, smart polymers or other such materials that may be disposable or non disposable.

In some embodiments, activation and/or ceasing of cleaning is controlled by the controller according to the closed loop image analysis. Optionally, clarity of the image is assessed, and if the image is not clear enough (for example clear enough so as to enable detection of cervical os) cleaning is activated.

A potential advantage of a controlling cleaning according the closed loop image analysis may include that cleaning is applied only when necessary. Optionally, no manual activation is required by the user and/or physician. Additionally or alternatively, a user controls applying of cleaning, for example via a cell phone application. In an example, a user receives images on her cell phone and if the image is blurred, the user can apply cleaning.

A potential advantage of an irrigation/washing system including suction of the fluid may include increasing comfort of the user.

Wearable device

FIG. 6 presents a wearable CEDMD 84 version, including, in accordance with some embodiments, adjustable cloth 86 (such as underwear), a control box 88 including a controller 18, an actuator 28 and an ultrasound transducer 90 and more. The control buttons 32 may be attached to the 5 adjusting stripes 92 or any other accessible place on the wearable CEDMD 84 or it can be on a remote device for example on the cell phone of the user 124 (see for example figure 9), as it operates the actuator 28. The control box 88 can be sawed, scotched, glued or any other matter of attachment. Optionally, the control box cover 94 is in contact with the body. In some embodiments, the ultrasound transducer 90 moves parallel to the feminine organs 96 through a trail 98 embedded on the surface of the control box cover 94. In some embodiments, the adjusting stripes 92 connect the frontal part of the adjustable cloth 86 to the posterior part.

In some embodiments, the user 124 wears the wearable CEDMD 84 the same way she wears underwear and uses the adjusting stripes 92 to suit her size. In some embodiments, when the adjustable cloth 86 is in place, the user 124 presses the control buttons 32, which operate the actuator 28. The actuator 28 initiates the movement of the ultrasound transducer 90 along the trail 98, adjacent to the feminine organs 96. The ultrasound transducer 90 transmits ultrasonic waves and receives the returning sound waves. In some embodiments, the controller 18 analyzes the data collected by the ultrasound transducer 90. Optionally, the ultrasound transducer 90 continues to move until the controller 18 identifies the external OS 54 or until the ultrasound transducer 90 reaches a threshold of cycles without locating the target. In some embodiments, when reaching the target, cervical dilation is assessed by measuring the radius of the hole in the external OS 54. Optionally, the control box 88 should be large enough to contain the ultrasound transducer 90, controller 18, actuator 28 and more and small enough to fit in the adjustable cloth 86. In some embodiments, the length of the control box 88 may be in the range of 0-20cm long and 0-10 cm high: from the control box cover 94 to the adjustable cloth 86. In some embodiments, the control box cover 94 is equivalent to the control box 88 in length and is within the same range of depth 30 (height). In some embodiments, the adjustable cloth 86 is available in different sizes such as small, medium and large but not limited to those sizes. In some embodiments, the ultrasound transducer 90 should be small enough to fit inside the control box 88 and move in it freely. In some embodiments, the control buttons 32 should be small to fit on an accessible area of the wearable CEDMD 84 or a distant device but large enough for the comfort of the user 124. In some embodiments, the control buttons 32 diameter can range between, for example, 0.5 cm and 2 cm. In some embodiments, the length of the trail 98 will not exceed the length of the control box cover 94, meaning within, for example, 0cm-20cm long.

In some embodiments, the adjustable cloth 86 is fabricated from natural clothing materials such as cotton, wool, silk, leather, denim, leather etc. or synthetic fibers, such as nylon, polyesters, spandex etc. or any combination of natural and synthetic materials. Optionally, the adjusting stripes 92 require highly flexible characteristics, and therefore be made of material such as rubber, nylon, polymers etc. Optionally, the control box 88 should compose of rigid and strong while light-weighted materials such as light-metal, wood, hard polymers and more. In some embodiments, the control box 88 may also be covered with soft substances such as gel polymer network materials. In some embodiments, the control box cover 94 comes in contact with the feminine organs 96 and therefore should be biocompatible and comfortable such as cotton, non-woven cloth, gel materials etc. In some embodiments, achieving an ultrasound transducer 90 may require additional components such as a beamforming unit, a transmit-receive switch, amplifier, filter etc. In some embodiments, the ultrasound transducer 90 may compose of piezoelectric ceramics and driving and receiving electrical impedance characteristics should match the electrical characteristics of the ultrasound transducer 90. In some embodiments, in case the control buttons 32 are accessible on the adjustable cloth 86, it should compose a strong enough material to press and send an electrical signal, materials as plastic, metal and such. Optionally, the functionality of the trail 98 requires strong material to hold the ultrasound transducer 90, while reduced friction is a necessity. Materials such as lubricated or covered metal, plastic, smooth surface polymers and more are good examples for the trail 98 materials, in accordance with some embodiments.

Exemplary device operation

FIG.7A is a schematic block diagram illustrating the software methodology of the CEDMD 10 (see for example FIG. 2B). In some embodiments, once the CEDMD device is located within the vagina 36(see for example FIG. 2B), the imager 14 (see for example FIG. 2B) control software regulates the actuator 28 (see for example FIG. 2B) to move in any direction required for allocating target 1 or imaging the cervix 116 (see for example FIG. 8).

In some embodiments, in addition or instead of the optical imager mechanism, one or more ultrasound transducers are used for obtaining images. Optionally, ultrasound scanning is employed from externally to the body. Alternatively, an ultrasound probe is inserted, as a part of the CEDMD device or separately. In some embodiments, when the ultrasound transducer 90 is utilized, an ultrasonic image of the cervix 116 is sent to a controller 18 to analyze the image, asses the length from external OS 54 to internal OS 100 or uterus 110 and display the results. In some embodiments, when the CMOS or other such image sensor 48 is utilized, a software allocates target one, the external OS 54. One optional method to find the external OS 54 is use the texture contrast feature to allocate regions with high texture within the image. This can be done, for example, by means of thresholding and connected components or using k- means or GMM-EM in color-texture feature space. Then, in some embodiments, within the detected regions look for a segment with a large amount of dark pixels (low values in L channel). Optionally, these pixels indicate the presence of the external OS 54 within the segment. In an exemplary algorithm used, if there are more than one such segments take the center segment with respect to image boundary. In some embodiments, region growing or mean-shift segmentation in color-texture feature space is applied, or watershed using gradients from the texture features map, to segment the external OS 54 out of the region. Optionally, if textured regions are too small (for example in young women), the algorithm starts with the darkest pixels in the image as anchor points for external OS 54 identification and then continues with the region growing or mean shift segmentation methods. Additionally, after learning the color of the tissue surrounding the external OS 54, it may be segmented to ensure the correct target. In some embodiments, if the external OS 54 is located but the image is blurred, the software of the cleaning mechanism 22 controls the actuator 28, which operates the cleaning mechanism 22. In some embodiments, when the image is clear, the opening of the external OS 54, indicating dilation, is measured. One optional method to assess cervical dilation is learning the image pixel size by moving a set unidirectional distance and comparing the image along the set distance. Optionally, when the pixel size is known, the diameter is measured. In some embodiments, cervical length 114 assessment occurs when dilation is above a pre-set threshold. Optionally, a software allocates target two, the internal OS 100 or the uterus 110. A second optional method to allocate a target is by first dividing the image into blocks (MXN pixels), and then extracting features (attributes) for each block using matched filter, GL manipulations, gradients, contrast, texture analysis. Following that, in some embodiments, feature extraction or dimensionality reduction techniques are applied. This can be done with or without interaction with the classifier: filter, wrapper or embedded methods. The following techniques may be applied, PC A, ICA, LDA, SNDA. In some embodiments, the next step may include utilizing machine learning technique to classify each block. This can be done for example using adaboost, linear andxor nonlinear SVM and neural networks. Eventually, in some embodiments, relevant blocks are clustered and target detection is performed according to blocks class sequence, shape, and/or number. In some embodiments, cervical length 114 is measured by assessing the distance from external OS 54 to internal OS 100 or from the fully inserted device to internal OS 100 or from fully inserted device to uterus 110, or from external OS 54 to uterus 110. Optionally, an additional software algorithm displays the results on dedicated screens.

Image processing algorithm

FIGs. 7Bi-ii are flowcharts of training a model and a testing an image acquired by the CEDMD device using the trained model, according to some embodiments.

In some embodiments, for example as detailed in figure 7Bi, a neural network model is trained using images in which the cervix was pre-identified. Then, for example as detailed in figure 7Bii, an acquired image is tested using the trained model. Optionally, a feature vector is produced for the tested image, and a classifier is applied for determining if the cervix is found in the tested image. If the cervix is found in the image, one or more parameters are assessed. The parameters may include, for example, dilation, effacement, a length of the cervix. Alternatively, if the cervix is not found in the image, another image is acquired and tested. Optionally, a position and/or orientation of the imager are changed before acquiring another image.

In some embodiments, the distance to an object is determined using automatic image analysis using a closed feedback system. Optionally, a predetermined acceptable error is reached without changing optical parameters of the imager such as DOF, focal point or others.

In some embodiments, the imager is moved relative to the object being captured, for example along a normal axis relative to the object being captured. Optionally, the imager advances in quantifiable and determined steps. Optionally, during each step (towards or away from the object), an image is acquired, and a set of images each representing a different step is produced.

In some embodiments, a distance between the different locations in which images are captured (the different steps) is known. Optionally, for every pair of images acquired at a known distance from each other, an order of the object appearing in the image and whether it has increased or decreased is determined. The increasing or decreasing order is the difference of a pixel size between the first and the second images, measured by an optical flow algorithm which calculates the differences for either all pixels or a sub group of pixels of the object itself. In some embodiments, measurement of distance to an object in a closed system is performed using the following equation:

ds= 1+ dz/Z

in which ds is the increased/ decreased order, Z is the distance to the object (in meters), dz is the distance between the locations in which the images were obtained.

In some embodiments, a set of equations is produced in accordance with the sampling size (the number of images taken at each known distance). Optionally, accuracy is improved by sampling a number (N) of images, producing N/2 equations and minimizing error (minimal least square error). Optionally, the larger the sampling size, the more accurate the distance assessment will be.

In some embodiments, the system re-samples the extreme error distances and optionally replaces the produced equations with more accurate data that may improve outcome accuracy. This process may be repeated until reaching a minimal preset error.

A potential advantage of the above described method and/or system may include reducing or preventing the need for altering imager characteristics, and instead utilizing mechanically operated, spatial movement of the imager. As the number of samples can be unlimited, high accuracy can be reached. This highly accurate measurement may be especially advantageous for assessing cervical dilation and/or other parameters with an accurate calibration system. A distance measurement methodology for example as describe herein may be applied for any distance measurement from an object, using closed loop feedback from an image processor. In some embodiments, analyzing of the images may be carried out by applying one or more of: image processing algorithms, pattern recognition algorithms, filtering (optionally using gradient descent optimization methods), thresholding, image convolution, segmentation, hyper parameter optimization, methods for extracting structures and/or objects from an image, and/or others.

Cervical length measurement

FIG. 8 shows the frontal portion 112 of internal chamber 16 is located inside the vagina 36 to further measure the cervical length 114, according to some embodiments. In addition, the cervix 116 in FIG. 8 is effaced and the space from the image sensor 48 through the lens 30 to the uterus 110 is wider and shorter than a not effaced cervix 116. In some embodiments, the tissue supporter 12 upkeeps the vaginal tissue to allow visualization. In some embodiments, the CEDMD 10 lumen 40 transfers electrical manners of communication between the image sensor 48 and the external unit 24. In some embodiments, the image sensor 48 comprises of but not limited to complementary metal-oxide-semiconductor (CMOS) and/ or ultrasonic sensor. Optionally, when the CMOS is used and the CEDMD 10 is fully inserted into the vagina 36, above a certain cervical dilation threshold, an algorithm is applied to measure cervical length 114. In some embodiments, the algorithm commands the image sensor 48 to search for a clear image of the lower part of the uterus 110. Optionally, as the image sensor 48 moves, in any manner of but not limited to the locomotion mentioned previously, and in any manner of but not limited to connection to the lens 30, as mentioned above, it shoots images. In some embodiments, once the image of the uterus 110 is clear and recognized, the imager 14 halts. Optionally, the cervical length 114 is measured by assessing the distance between the fully inserted device and the uterus 110.

In some embodiments, the frontal portion 112 is part of the internal chamber 16, which is inserted into the vagina 36. In some embodiments, the internal chamber 16 of the CEDMD 10 is sufficiently short and thin to enter the vagina 36 comfortably, such as about 2 to 6 centimeters long and about 1 to about 2 centimeters in outer diameter, when the tissue supporter 12 is not inflated. In some embodiments, the tissue supporter 12 inflates optimally for the comfort of the user 124 while creating a lumen 40, for instance, approximately, 2 to 5 centimeters. Effacement of the cervix 116 shortens the cervix 116, therefore, the CEDMD 10 may reach closer to the uterus 110. T In some embodiments, the distance within the depth of field, between the lens 30 and the uterus 110, for clear and focused image is from 0 cm to 10 cm. In some embodiments, the lens 30 is made of a biocompatible material with a very soft surface such as glass, plastic, smart polymers or others. In some embodiments, the tissue supporter 12 should be made of a biocompatible strong and flexible material that may be disposable such as plastic polymers for example PVC and PET or nylon. In some embodiments, the tissue supporter 12 may be coated for lubrication, for abrasion resistance or other reasons. The imager 14, in accordance with some embodiments, composes of an image sensor 48, such as CMOS, CCDs, EMCCD and or ultrasound transducer 90 or others.

Device communication

FIG. 9 presents the telemedicine wireless communication 126 between the CEDMD device and the environment, in accordance with some embodiments. In some embodiments, the information acquired by the CEDMD 10 can be sent out to a healthcare provider 118, a permitted personnel 120, a healthcare institution 122, the user 124 and/or others via wireless communication 126, according to some embodiments. In some embodiments, healthcare provider 118 includes but not limited to physicians, nurses, midwives and more. In some embodiments, a permitted personnel 120 may be any additional person of interest who is also permitted by the user 124. In some embodiments, a healthcare institution 122 includes hospitals, clinics, midwifery unit, birth centers and others. In some embodiments, the user 124 may receive the information to a dedicated remote device 26 with displayer 34, the displayer 34 on the external chamber 24 of the device or any other telecommunication devices. In some embodiments, the remote device 26 may include an external controller 18 to analyze the data, control buttons 32 and a displayer 34 to show the results.

In some embodiments, the actuator 28 within said the external chamber 24 is programmed to mechanically move the imager 14 until it focuses, through the lens 30, on the target. In some embodiments, the controller 18 processes the information. In some embodiments, the wireless signal transducer 128 sends out by wireless communication 126, data including the calculated results of the CEDMD 10. Optionally, the user 124 receives the information either to a remote device 26 where the results are displayed on the displayer 34, or to a displayer 34 on the external chamber 24. In some embodiments, the user 124 receives assessment of cervical dilation and when available, cervical effacement. Additional information for the user 124 may include the medical institution nearby, their locations, the number of available rooms, the relevant physicians on shift and comments or any other relevant information. Optionally, the data is also sent to a healthcare provider 118 as set in advance. In some embodiments, the healthcare provider 118 information will not be limited but may include the following: a dilation and effacement progression graph- including a single or multiple procedures that the user 124 has performed, an image, relevant information about the user 124 such as name, gestation, age, relevant medical history and more. In some embodiments, the permitted personnel will also obtain the same data as the user 124, updated location of the user 124 and any other relevant information. In some embodiments, the medical institution will get information about the status of the birth- giver, such as but not limited to the following: dilation and effacement, a graph of the progression of labor, medical history of the patient, name, age and other basic information. In some embodiments, the healthcare institution 122 will also learn the updated location of the birth-giver as well as how long it would take her to arrive at the institution. Optionally, the wireless communication 126 between the hospital and the CEDMD device will allow the hospital to prepare for the birth-giver and prioritize between birth-givers at any given moment based on the progression of labor as never before.

Feedback

FIG. 10 is a flowchart of a method of determining dilation rate and providing feedback to the user, according to some embodiments of the present invention.

In some embodiments, a CEDMD device is introduced into the vagina (1001), and a current dilation state is assessed from one or more images acquired by the device (1003). In some embodiments, if the measured dilation is within a predefined threshold or range, for example between 0 and 1 cm, measurement is repeated within a predefined time period, for example within 30 minutes (1005). Optionally, upon the initial measurement, the device sends out an indication the user and/or physician to perform another measurement within (or after) a certain time period. In some embodiments, a dilation rate is determined according to the successive measurements (1007) and according to the time period between them.

In some embodiments, a usage plan is defined and/or adjusted according to the detected rate and/or according to the dilation values and/or according to a trend in the dilation rate (1009). In some embodiments, a usage plan includes a timing for one or more measurements, a time interval between measurements, parameters to be obtained (for example: dilation, effacement, cervical length) and/or others. In some embodiments, the updated usage plan, the measurement results, the calculated dilation rate and/or other parameters are communicated to the user and/or physician (1011). Optionally, the system automatically sends out reminders to the user to perform measurement, for example via a cell phone application. In some embodiments, misuse or positioning are detected, for example automatically detected by sensors on the device and/or by the quality of the images obtained, and the system sends out warnings and/or instructions to the user, such as instructions for re-positioning the device.

In an exemplary method of operation, if the dilation rate remains constant for two or more successive measurements, the suggested time interval between measurements will be maintained constant or lengthened, for example until an increase in the dilation rate is detected; if an increase in dilation rate is detected, the suggested time interval between measurements will be reduced.

Optionally, indications are provided to the user based on the dilation value and/or rate, for example, for a dilation above a certain threshold, for example above 3 cm, the user will be advised to reach the hospital for labor.

FIG. 11 is an exemplary scheme for testing dilation rate and providing feedback to the user, in accordance with the described above in FIG. 10. While the parameter referred to herein is dilation, a similar scheme (with modified values) may be implemented for effacement values and/or other parameters obtained by the device.

In some embodiments, for example as shown herein, multiple measurements of dilation are performed one after the other within a time interval of, for example, 10 minutes, 15 minutes, 30 minutes, 45 minutes, 1 hour, or intermediate, longer or shorter time periods. Optionally, the time interval is automatically suggested by the device.

In some embodiments, an indication provided by the device is defined by comparing a current measurement result to one or more previous measurement results obtained by the user and/or by comparing to a population database and/or to a by comparing to a commonly known dilation value or rate. As can be seen from the exemplary scheme, if the measured value is higher than a threshold, (e.g. dilation is higher than 2.5 cm), a first type of indication is provided to the user (in this case, suggesting the user to go to the hospital), and if dilation is lower than a certain threshold, a second type of indication is provided to the user (in this case, to retest within a certain time period).

In some embodiments, a usage plan produced by the device takes into account one or more of: a current dilation value, a dilation rate assessed per the user according to the one or more previously acquired measurements; a state of contractions received as input into the device, and/or other related parameters.

FIG. 12 is an example of a device for imaging from within the vagina, according to some embodiments.

In some embodiments, device 1200 comprises an optical dome 1202, including imaging means. In some embodiments, the dome is rigid. Optionally, the dome is transparent.

In some embodiments, dome 1202 is coupled to a handle unit 1204. In some embodiments, the dome is attached to a distal end of handle 1204 via interference coupling, for example via matching protrusions and recesses. Optionally, the dome is rotated into a locking position with respect to the handle.

In some embodiments, a tissue supporter 1206 is positioned at the interface between the dome and the handle. Optionally, the tissue supporter comprises an elastic, inflatable member. In some embodiments, the tissue supporter is bounded by two flexible rings. Optionally, the tissue supporter comprises Latex and/or other elastic material.

In some embodiments, the tissue supporter rings are placed over the protrusions at the interface between the dome and the handle. Optionally, the rings seal the coupling, enabling inflation of the tissue supporter, for example via an opening 1208 and/or conduit formed in the handle.

In some embodiments, by coupling the rigid dome via the flexible, elastic tissue supporter, insertion and/or fitting of the device into position within the vagina are made easier as at least some degree of movement is enabled between the dome and the handle.

In some embodiments, the dome is disposable, and is replaced for example after each use and/or after a number of uses and/or after a certain period of time. In some embodiments, the handle is a permanent unit, which can be used with replacement domes.

In some embodiments, an elongated sheath extends proximally from the dome to cover at least a portion of the handle such as the portion inserted or otherwise in contact with the vagina or external genitalia. Optionally, the sheath is a sleeve that can be pulled over the handle. A sheath arrangement may enable maintaining a sterile environment and keep the device clean.

The terms "comprises", "comprising", "includes", "including", "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 form "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, various embodiments of this invention may be presented in 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, it is meant to include any cited numeral (fractional or integral) within the indicated range. The phrases "ranging/ranges between" a first indicate number and a second indicate number and "ranging/ranges from" a first indicate number "to" 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 numerals therebetween.

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.

As used herein, the term "treating" includes abrogating, substantially inhibiting, slowing or reversing the progression of a condition, substantially ameliorating clinical or aesthetical symptoms of a condition or substantially preventing the appearance of clinical or aesthetical symptoms of a condition.

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.

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.

All publications, patents and patent applications mentioned in this specification are herein incorporated in their entirety by reference into the specification, to the same extent as if each individual publication, patent or patent application was specifically and individually indicated 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.

Claims

WHAT IS CLAIMED IS:

1. A device for insertion, at least in part, into a vagina, comprising:

a body shaped and sized for vaginal insertion;

an imager contained within said body;

a controller in communication with said imager, said controller programmed to analyze data received from said imager; and

a tissue supporter coupled to said body, said tissue supporter expandable to push the vagina walls so as to create a line of sight from said imager to at least a portion of the cervix.

2. The device according to claim 1, wherein said tissue supporter is shaped and sized to fit within a vaginal applicator and to expand upon exiting said vaginal applicator.

3. The device according to claim 1, wherein said tissue supporter comprises a conical configuration when expanded.

4. The device according to claim 3, wherein said tissue supporter comprises a plurality of elongate ribs arranged to expand from a collapsed state to a conical configuration.

5. The device according to claim 3, wherein an apex of said tissue supporter faces away from the cervix when said device is inserted into the vagina.

6. The device according to claim 3, wherein an apex of said tissue supporter faces towards the cervix when said device is inserted into the vagina.

7. The device according to claim 6, wherein said apex is configured to collapse inwardly into a volume of said conical tissue supporter, causing a more proximal portion of said tissue supporter to protrude radially outwardly.

8. The device according to claim 3, wherein said tissue supporter, when expanded, applies non-uniform pressure onto the walls of the vagina.

9. The device according to claim 1, wherein said tissue supporter is shaped and sized for use in a pregnant woman's vagina.

10. The device according to claim 9, wherein said tissue supporter is sized to expand to a maximal diameter large enough to space out said walls of the vagina an amount sufficient for obtaining a selected field of view and small enough so as not to damage surrounding tissue.

11. The device according to claim 1, wherein said tissue supporter comprises one or more pressure sensors.

12. The device according to claim 11, wherein at least one of expanding and collapsing of said tissue supporter is performed based on an indication obtained by said sensor.

13. The device according to claim 1, wherein said controller is configured to automatically expand said tissue supporter when said apparatus is introduced to the vagina.

14. The device according to claim 1, wherein said tissue supporter is inflatable.

15. The device according to claim 14, wherein said tissue supporter comprises two spaced apart ring shaped balloons which expand to seal against the walls of the vagina.

16. The device according to claim 1, wherein said tissue supporter comprises shape memory material.

17. The device according to claim 1, wherein said tissue supporter expands to a cylindrical configuration.

18. The device according to claim 1, further comprising an actuator coupled to said imager, said actuator configured for manipulating a position of said imager with respect to said body.

19. The device according to claim 18, wherein said actuator comprises an elongated extension flexible enough to enable maneuvering of said imager.

20. The device according to claim 18, wherein said actuator is configured to position said imager at a selected angle with respect to the cervical os.

21. The device according to claim 1, wherein said controller is configured to assess at least one of cervical dilation and effacement from an image acquired by said imager.

22. The device according to claim 21, wherein said controller is programmed to generate an indication to a user based on said assessment.

23. The device according to claim 1, wherein said controller comprises a communication module for transferring images and/or measurements to external devices, systems or databases.

24. The device according to claim 23, wherein said communication module is configured to send and receive data from one or more of: a user, a healthcare institution, a healthcare provider.

25. The device according to claim 23, wherein said communication module is configured to send and receive data from a cellular phone.

26. The device according to claim 1, comprising a cleaning mechanism including at least one sprayer directed towards the cervix, and wherein said controller is programmed to actuate cleaning if an acquired image is blurred.

27. The device according to claim 1, wherein said imager is mounted on a ball and socket joint.

28. The device according to claim 1, wherein a distal end of said body comprises an optical window comprising one or more lenses.

29. A method for examining a cervix, comprising

introducing an imager into the vagina of a pregnant woman in her third trimester;

expanding a tissue supporter to push the walls of the vagina outwardly to an extent sufficient for enabling visual access to at least a portion of the cervix;

acquiring at least one image; and

analyzing said at least one image.

30. The method according to claim 29, wherein said analyzing comprises identifying at least a portion of the cervix in said image.

31. The method according to claim 30, wherein said identifying is carried out by a neural network modeling algorithm.

32. The method according to claim 29, wherein said analyzing comprises measuring cervical dilation.

33. The method according to claim 32, comprising assessing a diameter of the internal and/or external os to determine cervical dilation.

34. The method according to claim 32, further comprising calculating a dilation rate based on at least two images acquired over a period of time.

35. The method according to claim 29, wherein said analyzing comprises measuring cervical effacement.

36. The method according to claim 29, comprising generating an indication to a user based on said analyzing.

37. The method according to claim 36, wherein said indication comprises advising a user to reach the hospital for labor.

38. The method according to claim 36, wherein said indication comprises a usage plan advising the user to repeat measurements within a selected time interval.

39. The method according to claim 29, wherein said introducing comprises self- introducing.

40. The method according to claim 29, wherein said analyzing comprises determining if said image is blurred.

41. The method according to claim 40, comprising cleaning the cervix by irrigating with fluid if said image is blurred.

42. A tissue supporter for the vaginal canal, said tissue supporter mounted on a body shaped and sized for insertion into the vagina, said tissue supporter comprising:

an arrangement of elongated ribs, said ribs coupled to each other at their proximal ends and configured to expand from a collapsed configuration to an expanded configuration in which the ribs extend radially outwardly from each other to form a conical outer profile.

43. The tissue supporter according to claim 42, wherein said ribs comprise metal and/or plastic.

44. The tissue supporter according to claim 42, configured to expand to a maximal diameter of 10 cm.

45. A device for insertion, at least in part, into a vagina, comprising:

a body shaped and sized for vaginal insertion;

an imager contained within said body;

at least one fluid sprayer aimed distally;

wherein said controller controls said sprayer so as to spray the cervix upon an indication of a blurred image acquired by said imager and analyzed by said controller.

46. The device according to claim 45, comprising a suction nozzle which sucks the fluid sprayed by said fluid sprayer.

47. A method of monitoring fetal membranes, comprising:

acquiring an image of a cervix including a fetal membrane;

analyzing said image to identify said membrane;

analyzing said image of said identified membrane to detect at least one of bulging and rupturing of said fetal membrane.

48. A device for insertion, at least in part, into a vagina, comprising:

an optical dome;

a handle unit coupled to a proximal end of said optical dome;

an inflatable annular element positioned at an interface between said handle unit and said optical dome; and

a protective sheath extending proximally from said annular element, said sheath extendible over at least a portion of said handle unit.

49. The device according to claim 48, wherein said optical dome is detachable from said handle unit and replaceable.