WO2024157154A1

WO2024157154A1 - Device and method for cervical and fetal assessment during labor

Info

Publication number: WO2024157154A1
Application number: PCT/IB2024/050598
Authority: WO
Inventors: Roni CANTOR-BALAN; Yehonatan YONI BALAN
Original assignee: Ciconia Medical Inc
Current assignee: Ciconia Medical Inc
Priority date: 2023-01-23
Filing date: 2024-01-22
Publication date: 2024-08-02
Anticipated expiration: 2025-07-23
Also published as: EP4654881A1; CN120731038A; KR20250136376A; JP2026503467A

Abstract

A device for providing cervical and/or fetal parameters comprising: an imaging device; an inserter configured to aid insertion of the imaging device into a vaginal canal for imaging of a cervix and/or a fetus; and a processor in data communication with the imaging device and configured to use machine vision to determine the cervical and/or fetal parameters based on the respective imaging of the cervix and/or fetus.

Description

DEVICE AND METHOD FOR CERVICAL AND FETAL ASSESSMENT DURING LABOR

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims the benefit of priority of U.S. Provisional Patent Application No. 63/480,992 filed January 23, 2023, the contents of which are incorporated herein by reference in its entirety.

FIELD

Subject matter disclosed herein relates generally to obstetrics, and more particularly to cervical and fetal assessment before and during labor.

BACKGROUND

Digital (using fingers) vaginal examination is the current accepted method for measuring a cervix to determine labor progress. During the exam, a clinician assesses cervical dilation, cervical effacement (cervix thickness where thinner = closer to labor), cervical consistency (cervix softness where softer = closer to labor), position of the cervix (posterior or anterior) and the baby’s station and position. To perform the exam, the clinician inserts two fingers into the woman’s vagina and palpates the cervix and the surrounding area. Oftentimes, the examination may be repeated multiple times at the end of the pregnancy and during labor, and may be performed by different clinicians.

There are several potential disadvantages to digital vaginal examination. It may increase the chance of infection to both mother and baby due to the passage of bacteria from the vagina into the cervix, and this risk may increase with every additional examination. Further, due to the nature of the exam, it may provide an assessment rather than an accurate measurement of the above parameters. In the case of cervical dilation assessment, it has been found to be inaccurate in 50% of the times with up to 20% error. Yet further, the exam is subjective and greatly depends on the level of expertise of the clinician. For example, in 40% of cases, the same clinician repeating the exam might get different dilation results, and different clinicians might provide a different dilation assessment in 50% of cases. Moreover, 80% of women may find the examination painful or intolerable and embarrassing, which may lead the mother and/or clinician to refuse/refrain from performing the exam jeopardizing the mother and/or child. Further, in 20% of cases, such as high- risk pregnancies, placenta previa and early rupture of membranes, the vaginal exam cannot be used due to its higher risk of causing infection and bleeding.

During vaginal exams, clinicians may use a speculum to expand and support the vaginal wall and get visual access to the cervix. Since speculums are made of metal or hard plastic, many women report feeling discomfort when speculums are used during vaginal exams.

Cervical dilation is considered a key parameter for the assessment of labor progression. It provides the information upon which many labor intervention decisions may be based, including: inductions, c-sections, amniotomies, etc. However, there is currently no technological solution that can objectively and accurately measure cervical dilation. Due to the subjective nature of the exam, and its high error rate, the result may be false urgent operative interventions and dangerous prolonged labor or, may lead to incorrect administration of drugs in the event of a misdiagnosis of preterm birth.

Ultrasound may be used in some cases; however, the ultrasound technique is user-dependent and requires a high level of expertise in order to decipher the ultrasonic image. Devices for screening for cervical cancer such as an optical speculum are not meant, nor capable of measuring cervical dilation and effacement during labor, nor fetal position and station.

Therefore, there is a need for a device and method for assessing the cervix and the fetus during labor that does not require digital vaginal examination.

SUMMARY

In various embodiments there are provided medical devices and methods of use thereof for measuring cervical dilation and effacement as well as assessing the baby’s station and position, and conditions like vasa previa and placenta previa. Thus, rather than relying on a subjective practitioner examination with a high rate of inter and intra-observer variation, the device may perform an accurate measurement that is independent of the clinician who is operating it.

In some embodiments, the device may include an imaging device mounted on a flexible and/or a steerable shaft and operates within the vagina to capture images and videos of the exterior and interior of the cervix and of the fetus. In some embodiments, the device includes a monitor displaying a graphical user interface (GUI) that may present the captured images and videos, allowing automated or practitioner-initiated measurements on the objects in the field of view of the imaging device. In some embodiments, the device may include 3D imaging and computer vision capabilities such as a stereoscopic camera, laser scanner, LIDAR, structured light, depth maps from 2D images, or a combination of these. In some embodiments, imaging device may include an ultrasound probe that provides complementary images and information about the cervix and the status of the fetus. In some embodiments, the device can be operated external to the vaginal canal, such as transabdominally, transperineally or translabially, to provide complementary ultrasound images and quantitative data of the cervix and the fetus. In some embodiments, the device can employ doppler capabilities to help detect conditions such as placenta previa and vasa previa. In some embodiments, the device may include capabilities of assessing cervical consistency, such as light-induced fluorescence (LIF), Raman spectroscopy, near infrared imaging (NIRS), or elasticity sensor.

In some embodiments, a 3D capability and machine learning (ML) algorithms may allow extraction of dimensions and qualitative information related to the cervix and/or fetus, such as cervical dilation and effacement, and/or structural information about the cervix. In some embodiments, ML techniques may automatically extract dimensional and qualitative information related to the cervix and/or fetus and provide these to the device user.

In some embodiments, the device may provide a visual/auditory indication that the image within its field of view is of sufficient quality to run a successful image analysis, also signaling the operator to take a snapshot an/or record a video.

In some embodiments, the device may provide a visual/auditory indication that the image within its field of view is of sufficient quality to run a successful image analysis, also signaling the operator that automatic capturing of snapshots and/or video recording has begun.

In some embodiments, the imaging device may include a camera and laser to emit laser light diagonally to the axis of the cameras such that the position of the laser beam on the cervix changes with respect to the distance between the cervix and the camera. In some embodiments, using triangulation, the distance between the imaging device and the laser-illuminated cervix may be calculated based on the position of the laser spot on the image sensor of the endoscope. In some embodiments, the laser may be used as an aiming beam on the tissue, allowing the user to pin-point in real-time the location of interest. In some embodiments, a software algorithm incorporated in the device may use the laser spot on the tissue as a mark and can display a virtual ruler overlayed on the image with the graduation marks of the ruler changing according to the distance of the imaging device to the cervix. In some embodiments, with the virtual ruler overlayed on the image, a clinician may measure (on the monitor) the dilation of the cervix.

In some embodiments, captured images and videos, together with measurement data, may be recorded and kept in a patient’s file to be accessed as labor progresses. In some embodiments, a set of software measurement tools may be provided for the clinician to use on captured images and 3D renderings, to determine measurements of distance from point/line to point/line, area, diameter and thickness, thereby measuring the dilation and effacement of the cervix.

In some embodiments, the device may include a disposable inserter through which the shaft may be inserted into the vagina. The purpose of the inserter is to expand and support the vaginal walls in a way that will provide the imaging device with line-of-site to the cervix. The vaginal canal is by nature a collapsed vessel, and the cervix is located at the end of it and the inserter provides a more comfortable alternative to, for example, a speculum.

In some embodiments, the inserter may include a thin cylindrical channel, the width of a tampon or less (for example, between 15-20mm), that may include a dilator to be expanded inside the vagina to expand and support the vaginal walls. In some embodiments, the dilator may be foldable/collapsible into a housing in with a diameter roughly the size of a tampon. In some embodiments, the inserter may be inserted into the vagina, and, once the housing is pulled back, the dilator may expand and push against the vaginal walls.

In contrast to a digital vaginal exam where the spread of two fingers can reach 10 centimeters, the device may require minimal expansion, thereby minimizing the level of discomfort.

In some embodiments, the data measured can be saved and accessed at any time, allowing tracking of the progress of labor. In some embodiments, measured data may be uploaded to a hospital/clinic network to be saved under the patient’s file.

Although the device may be required to be used multiple times during labor to monitor the cervix, due to its higher accuracy compared to the current vaginal exam, and the additional visual information it provides, it is anticipated that fewer measurements would be needed in order to track labor progress, thereby reducing the risk of infection and medical complications. It is also anticipated that unnecessary labor interventions may be minimized while basing decisions on accurate device-measured data rather than on potentially incorrect manually-assessed parameters.

In cases where a vaginal exam cannot be used, the disclosed device offers a solution as it still operates within the vagina but does not have to come into contact with the cervix (except for optionally measuring cervical consistency provided in some embodiments), enabling collection of information from a distance. This contactless measurement is helpful in reducing the risk of infection in normal pregnancies as well.

It is anticipated that images and videos of cervixes captured by the device may be used to create a database that serves as educational material in universities and hospitals that may be used by the scientific community to further study cervical changes during pregnancy and labor.

Consistent with some disclosed embodiments, a device for providing cervical and/or fetal parameters may include: an imaging device; an inserter configured to aid insertion of the imaging device into a vaginal canal for imaging of a cervix and/or a fetus; and a processor in data communication with the imaging device and configured to use machine vision to determine the cervical and/or fetal parameters based on the respective imaging of the cervix and/or fetus.

In some embodiments, the device further includes a flexible shaft having the imaging device attached thereto at a distal end, wherein the processor is configured to steer the flexible shaft to aim the imaging device. In some embodiments, the device further includes a handle having the shaft attached thereto at a distal end; wherein the processor is housed inside the handle, wherein the handle includes a controller for controlling the device.

In some embodiments, the device further includes a monitor configured to display a GUI generated by the processor, the GUI including imaging captured by the imaging device and the cervical and/or fetal parameters. In some embodiments, the inserter includes a housing and a dilator, wherein the dilator is configured to fold into the housing and to expand when pushed out of the housing, and wherein the dilator is sufficiently rigid to dilate the vaginal canal.

In some embodiments, the cervical parameters are selected from the list including cervical dilation, cervical effacement, and cervical consistency. In some embodiments, the fetal parameters are selected from the list including fetal position, vasa previa, placenta previa, and fetal station.

In some embodiments, the imaging device is selected from the group consisting of: a 3D imaging device, a stereoscopic camera, DID AR, a structured light scanner, an ultrasound scanner, a laser scanner, a camera, a single camera using 2D depth maps, a doppler ultrasound scanner, and a combination of the above. In some embodiments, the imaging device includes a laser configured to be aimed at edges of the cervix, wherein the processor is configured to display on a GUI a virtual ruler overlaid on a captured image by the imaging device of the cervix featuring light from laser to enable measurement of cervical dilation.

In some embodiments, captured images or videos are saved on the device or uploaded to an external computing device. In some embodiments, the processor is configured to present a 3D reconstruction of the cervix on a GUI based on imaging from the imaging device.

In some embodiments, the imaging device may include a light source for illumination. In some embodiments, the device is further configured to provide light-induced fluorescence (DIF), Raman spectroscopy, or NIRS, and further configured to assess cervical consistency using the DIF, Raman spectroscopy, or NIRS. In some embodiments, the device further includes an elasticity sensor and further configured to assess cervical consistency using the elasticity sensor. In some embodiments, the device is further configured to provide a visual/auditory indication that an image within a field of view of the imaging device is of sufficient quality to run an image analysis or to capture an image or video. In some embodiments, the device is further configured to provide a visual/auditory indication that automatic capturing of an image or video has begun.

Consistent with some disclosed embodiments a method for providing cervical and/or fetal parameters may include: providing the above device; inserting the housing into the vaginal canal; expanding the dilator out of the housing into the vaginal canal; moving the imaging device through the housing and dilator to capture imaging of the cervix and/or fetus; and by the processor, determining of the cervical and/or fetal parameters based on the respective imaging of the cervix and/or fetus.

Consistent with some disclosed embodiments a method for providing cervical and/or fetal parameters may include: providing the above device; operating the device transabdominally, transperineally, or translabially to capture imaging of the cervix and/or fetus; and by the processor, determining the cervical and/or fetal parameters based on the respective imaging of the cervix and/or fetus.

This Summary is provided to introduce a selection of concepts in a simplified form that may be further described in the Detailed Description below. It may be understood that this Summary is not intended to identify key features or essential features of the disclosure, nor is it intended to be used to limit the scope of the disclosure. The details of one or more embodiments disclosed herein may be set forth in the accompanying drawings and the description below. Other features will be apparent from the description and drawings, and from the claims.

BRIEF DESCRIPTION OF THE DRAWINGS

Non-limiting embodiments disclosed herein are described below with reference to figures attached hereto that are listed following this paragraph, identical structures, elements or parts that appear in more than one figure are generally labeled with the same numeral in all the figures in which they appear. When similar reference numerals are shown, corresponding description(s) are not repeated, and the interested reader is referred to the previously discussed figure(s) for a description of the like element(s). The drawings and descriptions are meant to illuminate and clarify embodiments disclosed herein, but should not be considered limiting in any way. In particular, variations and modifications apparent to those skilled in the art may be considered without departing from the claimed scope.

FIGS. 1A-1B are illustrations of a cervical measuring device according to some embodiments disclosed herein;

FIG. 1C is a block diagram showing the components of a cervical measuring device according to some embodiments disclosed herein;

FIG. 2A shows a flow diagram of a process for use of a cervical measuring device according to some embodiments disclosed herein;

FIGS. 2B-2E show illustrations of the use of a cervical measuring device according to some embodiments disclosed herein.

DETAILED DESCRIPTION

FIGS. 1 A-1B are illustrations of a cervical measuring device 100 (hereinafter “device 100”) according to some embodiments disclosed herein. FIG. 1C is a block diagram showing the components of a cervical measuring device 100 according to some embodiments disclosed herein. In some embodiments, device 100 may include: an imaging device 110, a shaft 112, a handle 114, a monitor 116, a processor 118, and an inserter 120. In some embodiments, imaging device 110 may be a 3D imaging device. In some embodiments, imaging device 110 may include a stereoscopic camera, LIDAR, structured light scanner, an ultrasound scanner, a laser scanner, a single camera using 2D depth maps or a combination of any of these. In some embodiments, imaging device 110 may include a light source for illumination. In some embodiments, imaging device 110 may include a distance measurement laser. In some embodiments, imaging device 110 may include doppler capability. In some embodiments, device 110 may include capabilities of assessing cervical consistency, such as light- induced fluorescence (LIF), Raman spectroscopy, near infrared imaging (NIRS), or an elasticity sensor.

In some embodiments, imaging device 110 is mounted on the distal end of shaft 112. In some embodiments, shaft 112 may have a diameter of 10-30 mm. In some embodiments, shaft 112 may have a length of 15-30 cm. In some embodiments, shaft 112 or portions thereof may be flexible and or/steerable such that shaft 112 may be controlled by a controller 115 on handle 114 to flex so as to aim imaging device 110 in a desired direction.

Handle 114 may be held by a practitioner when device 100 is in use and may include controller 115 on a proximal end of handle 114. In some embodiments, controller 115 may control of the movement of shaft 112, and operation of imaging device 110. In some embodiments, controller 115 may include one or more buttons, a touch screen or other interface components enabling manipulation of device 100 by a clinician. In some embodiments, handle 114 or another part of device 100 may include a power source (such as a battery) so that device 100 may be used wirelessly.

Device 100 may include a processor 118 and device may therefore be a computing device as defined herein. Processor 118 and the modules and components that are included in device 100 may include or may be in communication with a non-transitory computer readable medium (such as memory 119) containing instructions that when executed by at least one processor (such as processor 118) are configured to perform the functions and/or operations necessary to provide the functionality described herein. Processor 118 may manage the operation of the components of device 100 and may direct the flow of data between the components of device 100. Where device 100 may be said herein to provide specific functionality or perform actions, it should be understood that the functionality or actions may be performed by processor 118 that may call on other components of device 100. Processor 118 may be implemented by various types of processor devices and/or processor architectures including, for example, embedded processors, communication processors, graphics processing unit (GPU), soft-core processors and/or embedded processors. Processor may be in data communication with the other components of device 100, such as imaging device 110, shaft 112, controller 115 and/or monitor 116.

In some embodiments (such as shown in FIG. 2D), monitor 116 may be attached to handle 114. In some embodiments, monitor 116 may be separate from handle 114. Monitor 116 may display a graphical user interface (GUI) generated by processor 118. In some embodiments, monitor 116 may include human interface components such as a touch screen by which the user can interact with device 100 along with, or as an alternative to controller 115.

In some embodiments, device 100 may include a communication module (not shown) for enabling the transmission and/or reception of data (such as captured images and measurements), optionally over a communication network.

In some embodiments, device 100 may include an introducer/inserter 120 (herein “inserter 120”). In some embodiments, inserter 120 includes a housing 122 and a dilator 124. In some embodiments, housing 122 may have a cylindrical shape with a hollow central lumen that is larger than the diameter of imaging device 110. In some embodiments, housing 122 may have a diameter of between 10-20mm. In some embodiments, inserter 120 may be a single- use sterile attachment into which shaft 112 may be inserted prior or after insertion of inserter 120 into a vaginal canal 134 (FIG. 2B).

In some embodiments, inserter 120 may have two configurations, namely, a deflated/folded configuration where dilator 124 is folded into housing 122 and an inflated/expanded configuration where dilator 124 is expanded out of housing 122. In some embodiments, dilator is sufficiently firm so as to dilate a vaginal canal 134 (FIG. 2B) when dilator 124 presses against the walls of vaginal canal 134.

In some embodiments, dilator 124 may be folded along a longitudinal axis to a diameter small enough to fit inside housing 122. In use, once housing 122 is inserted into the vaginal canal 134, the folded dilator 124 may be pushed out of housing 122 and unfold to its full diameter thus pressing against the walls of vaginal canal 134 and dilating the vaginal canal 134.

In some alternative embodiments, inserter 120 may include an inflatable portion (not shown) attached to an outside surface of dilator 124 that may be inflated once dilator 124 is pushed out of housing 122 inside vaginal canal 134 (FIG. 2B) to exert pressure against the walls of vaginal canal 134, thus creating vaginal dilation.

In use, device 100 may be operated internally (endovaginally) or externally. For example, internal use may leverage both camera imaging and ultrasound, whereas external use may rely solely on ultrasound.

FIG. 2A shows a flow diagram of a process 200 for use of device 100 in accordance with embodiments disclosed herein. FIGS. 2B-2E show illustrations of the use of device 100 for viewing a cervix 130, before birth of a fetus 132, after insertion of device 100 into a vaginal canal 134 according to some embodiments disclosed herein.

A non-transitory computer readable medium may contain instructions which, when executed by at least one processor, may perform the method and operations described at one or more of the steps in process 200. The non-transitory computer readable medium and the at least one processor may correspond to one or more of processor 118, and memory 119 of device 100, and/or other components of device 100. Process 200 may make use of machine learning processes as defined herein.

In step 202, such as shown in FIG. 2B, a clinician may insert inserter 120 into vaginal canal 134 in its folded configuration and may move inserter 120 toward the cervix. In step 204, such as shown in FIG. 2C, once in a position that will enable imaging device 110 to capture a view of the cervix 130, inserter 120 may be expanded, such as by pushing dilator 124 out of housing 122, such that dilator presses on the walls of vaginal canal 134 to thereby dilate the walls of vaginal canal 134

In step 206, such as shown in FIG. 2D, the clinician may push shaft 112 through inserter 120 and manipulate shaft 112 (such as with controller 115) until a view of cervix 130 acquired by imaging device 110 is shown on monitor 116. In some embodiments, inserter 120 may be pushed further into vaginal canal 134 to enable shaft 112 to be pushed further into vaginal canal until a view of cervix 130 acquired by imaging device 110 is shown on monitor 116.

In some embodiments, in step 208, the view from imaging device 110 may be adjusted, for example using controller 115 or a touch screen of monitor 116, including but not limited to adjusting the amount of light, focus and zoom. In step 210, such as shown in FIGS. 2D and 2E, the exterior and interior of cervix 130 and fetus 134 during pregnancy and labor may be imaged from within vaginal canal 134 or externally by device 100. As above, imaging device 110 may include, for example a camera as well as an ultrasound scanner for capturing images and videos of the exterior and interior of cervix 130 as well as fetus 134. Step 210 may include using device 100 (such as via controller 115) for capturing images and recording videos of the exterior and interior of cervix 130 and fetus 134 provided by imaging device 110. In some embodiments, device 100 may be used externally to vaginal canal 134 and steps 202-204 may be skipped. For example, where imaging device 110 includes an ultrasound scanner, this may be used for capturing images or videos as described below as part of step 210. In some embodiments, device 100 may be used transabdominally, transperineally or translabially.

In some embodiments, processor 118 may initiate capture of images and videos by imaging device 110 and then use machine vision techniques to automatically perform measurements related to the exterior and interior of cervix 130 as well as fetus 134 and to suggest results to a clinician via monitor 116. In some embodiments, measurements performed automatically by device 100 may include cervical dilation, cervical length (effacement), fetal position, fetal station, conditions such as placenta previa and vasa previa, and the level of cervical consistency. In some embodiments, machine learning/machine vision algorithms may be trained to automatically segment and identify the imaged anatomies (cervix, fetus), as well as perform the measurements and display them on monitor 116. In some embodiments, fetal station may be measured using machine vision with respect to ischial spines or pubic bones or other bony structures and reported as a distance in centimeters. In some embodiments, fetal position may be analyzed by a machine learning algorithm with results provided in clinical terms. It should be appreciated that such an approach may significantly simplify the effort required by a clinician who only needs to perform steps 202-208 before device 100 works to automatically provide extensive useable information.

In some embodiments, step 210 may further include activating (automatically by device 100 or by a clinician) a distance measuring component (such as a laser) of imaging device 110, aimed at the edges of cervix 130 to overlay a virtual ruler on monitor 116 to thus enable a real-time accurate measurement of cervical dilation.

Additionally or alternatively, in some embodiments, a clinician may use device 100 to perform dimension measurements on captured images of cervix 130. In some embodiments, captured images or videos may be saved on device 100 or may be uploaded to an external computing device (such as but not limited to the hospital network and the patient’s data file). In some embodiments, captured images and videos can be accessed to be used to compare against previous or future images acquired by device 100 during the progress of labor.

In some embodiments, processor 118 may operate a 3D reconstruction algorithm to present the cervix in 3D on the screen based on imaging from imaging device 110.

In some embodiments, image measurement tools may be shown on monitor 116 to allow the clinician to manually measure different dimensions of the cervix, such as dilation and effacement. In some embodiments, imaging device 110 may provide a combination of ultrasound and structured light data (or any other optical method mentioned above) that may be processed by processor 118 for displaying information about the structure and the dynamics of cervix 130 and/or the position of fetus 132 as labor progresses.

Steps 206 and 208 or only step 206 or only step 208 may be repeated for each image/video capture/analysis of step 210.

In step 212, once step 210 has been completed, device 100 may be pulled out of vaginal canal 134. In some embodiments, inserter 120 may be folded to its minimal size configuration by withdrawing dilator 124 into housing 122 before removal from vaginal canal 134. Process 200 may be repeated (such as shown by arrow 214) during birth as needed to monitor the cervix and fetus.

Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art. The materials, methods, and examples provided herein are illustrative only and not intended to be limiting.

Disclosed embodiments include methods, systems, devices, and computer-readable media. For providing a technical solution to the challenging technical problem of measurements of cervical and fetal related data during pre-birth or birth, and relate to a system for providing cervical dilation measurement with the system having at least one processor (e.g., processor, processing circuit or other processing structure described herein). For ease of discussion, example methods are described below with the understanding that aspects of the example methods apply equally to systems, devices, and computer-readable media. For example, some aspects of such methods may be implemented by a computing device or software running thereon. The computing device may include at least one processor (e.g., a CPU, GPU, DSP, FPGA, ASIC, or any circuitry for performing logical operations on input data) to perform the example methods. Other aspects of such methods may be implemented over a network (e.g., a wired network, a wireless network, or both).

As another example, some aspects of such methods may be implemented as operations or program codes in a non-transitory computer-readable medium. The operations or program codes may be executed by at least one processor. Non-transitory computer readable media, as described herein, may be implemented as any combination of hardware, firmware, software, or any medium capable of storing data that is readable by any computing device with a processor for performing methods or operations represented by the stored data. In a broadest sense, the example methods are not limited to particular physical or electronic instrumentalities, but rather may be accomplished using many differing instrumentalities.

Implementation of methods disclosed herein may involve performing or completing certain selected tasks or steps manually, automatically, or a combination thereof. Moreover, according to actual instrumentation and equipment, several selected steps may be implemented by hardware (HW) or by software (SW) on any operating system of any firmware, or by a combination thereof. For example, as hardware, selected steps could be implemented as a chip or a circuit. As software or algorithm, selected steps could be implemented as a plurality of software instructions being executed by a computer using any suitable operating system. In any case, selected steps could be described as being performed by a data processor, such as a computing device for executing a plurality of instructions.

Although the disclosure refers to a “processor”, “computing device”, a “computer”, or “mobile device”, it should be noted that optionally any device featuring a data processor and the ability to execute one or more instructions may be described as a computing device, including but not limited to any type of personal computer (PC), a server, a distributed server, a virtual server, a cloud computing platform, a cellular telephone, an IP telephone, a smartphone, a smart watch or a PDA (personal digital assistant). Any two or more of such devices in communication with each other may form a “network” or a “computer network”.

To provide for interaction with a user, the systems and techniques described here can be implemented on a computer having a display device (a LED (light-emitting diode), or OLED (organic LED), or LCD (liquid crystal display) monitor/screen) for displaying information to the user and a keyboard and a pointing device (e.g., a mouse or a trackball) by which the user can provide input to the computer. Other kinds of devices can be used to provide for interaction with a user as well; for example, feedback provided to the user can be any form of sensory feedback (e.g., visual feedback, auditory feedback, or tactile feedback); and input from the user can be received in any form, including acoustic, speech, or tactile input, t

In some embodiments, a system disclosed herein may be implemented on one or more servers or storage systems and/or services associated with a business or corporate entity, including for example, a file hosting service, cloud storage service, a hardware server, a virtual server, an online file storage provider, a peer-to-peer file storage or hosting service and/or a cyber locker. In some embodiments, the system disclosed herein may be provided in various deployments models including but not limited to cloud based, hardware server, or virtual.

Memory may include one or more types of computer-readable storage media including, for example, transactional memory and/or long-term storage memory facilities and may function as file storage, document storage, program storage, and/or as a working memory. The latter may, for example, be in the form of a static random-access memory (SRAM), dynamic random-access memory (DRAM), read-only memory (ROM), cache or flash memory. As long-term memory, memory may, for example, include a volatile or non-volatile computer storage medium, a hard disk drive, a solid-state drive, a magnetic storage medium, a flash memory and/or other storage facility. A hardware memory facility may, for example, store a fixed information set (e.g., software code) including, but not limited to, a file, program, application, source code, object code and the like.

As used herein the terms “machine learning”, “machine vision”, or “artificial intelligence” refer to use of algorithms on a computing device that parse data, learn from the data, and then make a determination or generate data, where the determination or generated data is not deterministically replicable (such as with deterministically oriented software as known in the art). In some embodiments, machine learning algorithms (also referred to herein as machine learning models or artificial intelligence) may be trained using training examples. Further, in some examples, training machine learning algorithms using training examples may generate a trained machine learning algorithm, and the trained machine learning algorithm may be used to estimate outputs for inputs not included in the training examples. In some examples, a machine learning algorithm may have parameters and hyper parameters. While certain steps methods are outlined herein as being executed by a specific module and other steps by another module, this should by no means be construed limiting.

It should be understood that where the claims or specification refer to “a” or “an” element, such reference is not to be construed as there being only one of that element. In the description and claims of the present application, each of the verbs, “comprise” “include” and “have”, and conjugates thereof, are used to indicate that the object or objects of the verb are not necessarily a complete listing of components, elements or parts of the subject or subjects of the verb.

While this disclosure has been described in terms of certain embodiments and generally associated methods, alterations and permutations of the embodiments and methods will be apparent to those skilled in the art. The disclosure is to be understood as not limited by the specific embodiments described herein, but only by the scope of the appended claims.

Claims

WHAT IS CLAIMED IS:

1. A device for providing cervical and/or fetal parameters, comprising: an imaging device; an inserter configured to aid insertion of the imaging device into a vaginal canal for imaging of a cervix and/or a fetus; and a processor in data communication with the imaging device and configured to use machine vision to determine the cervical and/or fetal parameters based on the respective imaging of the cervix and/or fetus.

2. The device of claim 1, further comprising a flexible shaft having the imaging device attached thereto at a distal end, wherein the processor is configured to steer the flexible shaft to aim the imaging device.

3. The device of claim 2, further comprising a handle having the shaft attached thereto at a distal end, wherein the processor is housed inside the handle, and wherein the handle includes a controller for controlling the device.

4. The device of claim 1, further comprising a monitor configured to display a graphical user interface (GUI) generated by the processor, the GUI including imaging captured by the imaging device and the cervical and/or fetal parameters.

5. The device of claim 1, wherein the inserter includes a housing and a dilator, wherein the dilator is configured to fold into the housing and to expand when pushed out of the housing, and wherein the dilator is sufficiently rigid to dilate the vaginal canal.

6. The device of claim 1 , wherein the cervical parameters are selected from a group consisting of cervical dilation, cervical effacement, and cervical consistency.

7. The device of claim 1 , wherein the fetal parameters are selected from a group consisting of fetal position, vasa previa, placenta previa, and fetal station.

8. The device of claim 1, wherein the imaging device is selected from a group consisting of a 3D imaging device, a stereoscopic camera, LIDAR, a structured light scanner, an ultrasound scanner, a laser scanner, a camera, a single camera using 2D depth maps, a doppler ultrasound scanner, and a combination of the above.

9. The device of claim 1 , wherein the imaging device includes a laser configured to be aimed at edges of the cervix, wherein the processor is configured to display on a graphical user interface (GUI) a virtual ruler overlaid on a captured image by the imaging device of the cervix featuring light from laser to enable measurement of cervical dilation.

10. The device of claim 1, wherein captured images or videos are saved on the device or uploaded to an external computing device.

11. The device of claim 1, wherein the processor is configured to present a 3D reconstruction of the cervix on a graphical user interface (GUI) based on imaging from the imaging device.

12. The device of claim 1, wherein the imaging device may include a light source for illumination.

13. The device of claim 1, further configured to provide light-induced fluorescence (LIF), Raman spectroscopy, or near infrared imaging (NIRS) and further configured to assess cervical consistency using the LIF, Raman spectroscopy, or NIRS.

14. The device of claim 1 , further including an elasticity sensor and further configured to assess cervical consistency using the elasticity sensor.

15. The device of claim 1, further configured to provide a visual/auditory indication that an image within a field of view of the imaging device is of sufficient quality to run an image analysis or to capture an image or video.

16. The device of claim 15, further configured to provide a visual/auditory indication that automatic capturing of an image or video has begun.

17. A method for providing cervical and/or fetal parameters comprising: providing the device of any one of claims 1-16; inserting the housing into the vaginal canal; expanding the dilator out of the housing into the vaginal canal; and moving the imaging device through the housing and dilator to capture imaging of the cervix and/or fetus.

18. The method of claim 17, further including, determining by the processor of the cervical and/or fetal parameters based on the respective imaging of the cervix and/or fetus.

19. A method for providing cervical and/or fetal parameters comprising: providing the device of claims 1-16; operating the device transabdominally, transperineally, or translabially to capture imaging of the cervix and/or fetus; and by the processor, determining the cervical and/or fetal parameters based on the respective imaging of the cervix and/or fetus.