Device and method for cervix and fetal assessment during delivery

Abstract

An apparatus for providing cervical and / or fetal parameters, the apparatus comprising: an imaging device; an inserter configured to assist in insertion of the imaging device into a vaginal lumen for imaging the cervix uteri and / or a fetus; and a processor in data communication with the imaging device and configured to determine cervical parameters and / or fetal parameters based on respective imaging of the cervix and / or the fetus using machine vision.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims the benefit of priority to U.S. Provisional Patent Application No. 63 / 480,992, filed on January 23, 2023, which is incorporated herein by reference in its entirety. Technical Field

[0003] The subject matter disclosed herein relates generally to obstetrics and gynecology, and more particularly to cervical and fetal assessment before and during labor. Background Art

[0004] A digital vaginal examination (using the fingers) is the currently accepted method for measuring the cervix to determine the progress of labor. During the examination, the clinician assesses cervical dilation, cervical effacement (thinner cervix = closer to labor), cervical texture (softer cervix = closer to labor), cervical position (posterior or anterior), and the height and position of the baby's presenting part. To perform the examination, the clinician inserts two fingers into the woman's vagina and palpates the cervix and surrounding area. Typically, the examination is repeated multiple times at the end of pregnancy and during labor and may be performed by different clinicians.

[0005] The digital vaginal examination (DV) presents several potential disadvantages. Because bacteria enter the cervix from the vagina, DVs can increase the chance of infection for both mother and baby, and this risk increases with each additional test. Furthermore, due to the nature of the test, it can provide an estimate of the aforementioned parameters rather than an exact measurement. In the case of cervical dilation assessment, it has been found to be inaccurate 50% of the time, with errors as high as 20%. Furthermore, the examination is subjective and largely dependent on the clinician's expertise. For example, repeated examinations by the same clinician may yield different dilation results in 40% of cases, while different clinicians may provide different dilation assessments in 50% of cases. Furthermore, 80% of women may find the examination painful, unbearable, and embarrassing, which may lead the mother and / or clinician to refuse / not perform the examination, thereby endangering the mother and / or child. Furthermore, in 20% of cases, such as high-risk pregnancies, placenta previa, and premature rupture of membranes, the DV examination cannot be used due to its high risk of infection and bleeding.

[0006] During a vaginal examination, a clinician may use a speculum to spread and support the vaginal walls and gain visual access to the cervix. Because speculums are made of metal or hard plastic, many women report discomfort when using a speculum during a vaginal examination.

[0007] Cervical dilation is considered a key parameter for assessing labor progress. It provides information upon which numerous labor intervention decisions are based, including induction of labor, cesarean section, and amniocentesis. However, no technical solution currently exists to objectively and accurately measure cervical dilation. Due to the subjective nature of this examination and its high error rate, the result can be erroneous emergency surgical intervention, dangerous delayed labor, or even inappropriate medication use in the case of misdiagnosis of preterm labor.

[0008] Ultrasound can be used in some cases; however, ultrasound technology is user-dependent and requires a high level of expertise to interpret the ultrasound images. Devices used to screen for cervical cancer (such as optical speculum) do not necessarily prevent the measurement of cervical dilation and effacement, fetal position, and presenting part height during labor.

[0009] Therefore, there is a need for a device and method for evaluating the cervix and fetus during labor that does not require a digital vaginal examination. Summary of the Invention

[0010] In various embodiments, medical devices and methods of use are provided for measuring cervical dilation and effacement, and for assessing the height and position of the infant's presenting part, as well as conditions such as vasa previa and placenta previa. Thus, the device can perform accurate measurements independent of the clinician operating it, rather than relying on subjective practitioner examinations with high inter- and intra-observer variability.

[0011] In some embodiments, the device may include an imaging device mounted on a flexible and / or steerable shaft and operated intravaginally to capture images and video of the exterior and interior of the cervix and the fetus. In some embodiments, the device includes a monitor that displays a graphical user interface (GUI) that can present the captured images and video, allowing for automated or practitioner-initiated measurements of objects in the imaging device's field of view. In some embodiments, the device may include 3D imaging and computer vision capabilities, such as a stereo camera, a laser scanner, LIDAR, structured light, a depth map from a 2D image, or a combination of these. In some embodiments, the imaging device may include an ultrasound probe that provides complementary images and information about the status of the cervix and fetus. In some embodiments, the device may be operated outside the vaginal lumen (e.g., via a transabdominal, transperineal, or translabial approach) to provide complementary ultrasound images and quantitative data of the cervix and fetus. In some embodiments, the device may employ Doppler capabilities to assist in detecting conditions such as placenta previa and vasa previa. In some embodiments, the device may include the ability to assess cervical texture, such as light-induced fluorescence (LIF), Raman spectroscopy, near-infrared imaging (NIRS), or elastic sensors.

[0012] In some embodiments, 3D capabilities and machine learning (ML) algorithms can allow for the extraction of dimensional 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 can automatically extract dimensional and qualitative information related to the cervix and / or fetus and provide this information to the device user.

[0013] In some embodiments, the device may provide a visual / auditory indication that the image within the device's field of view is of sufficient quality for image analysis to be successfully run, and also signal an operator to take a snapshot and / or record video.

[0014] In some embodiments, the device may provide a visual / audible indication that the image within the device's field of view is of sufficient quality for image analysis to be successfully run, and also signal to the operator that automatic capture of snapshots and / or video recording has begun.

[0015] In some embodiments, the imaging device may include a camera and a laser that emits laser light diagonally relative to the axis of the camera so that the position of the laser beam on the cervix changes relative to the distance between the cervix and the camera. In some embodiments, using triangulation, the distance between the imaging device and the laser-irradiated cervix can be calculated based on the position of the laser spot on the image sensor of the endoscope.

[0016] In some embodiments, the laser can be used as an aiming beam on the tissue, allowing the user to precisely locate the location of interest in real time. In some embodiments, software algorithms incorporated into the device can use the laser spot on the tissue as a marker and can display a virtual ruler superimposed on the image, where the scale markings on the ruler vary depending on the distance from the imaging device to the cervix. In some embodiments, with the virtual ruler superimposed on the image, the clinician can measure the dilation of the cervix (on the monitor).

[0017] In some embodiments, the captured images and videos along with the measurement data can be recorded and saved in the patient's files to be accessed as labor progresses. In some embodiments, the clinician can be provided with a set of software measurement tools to use on the captured images and 3D renderings to determine point / line to point / line distance, area, diameter, and thickness measurements, thereby measuring the degree of dilation and effluvium of the cervix.

[0018] In some embodiments, the device may include a disposable inserter through which the shaft can be inserted into the vagina. The purpose of the inserter is to expand and support the vaginal wall in a manner that will provide a line of sight of the cervix for imaging devices. The vaginal lumen is essentially a collapsed vessel, with the cervix located at the end of the vaginal lumen, and the inserter provides a more comfortable alternative to, for example, a speculum.

[0019] In some embodiments, the inserter can include a thin cylindrical channel, the width of a tampon or less (e.g., between 15 mm and 20 mm), which can include a dilator that expands inside the vagina to expand and support the vaginal walls. In some embodiments, the dilator can be foldable / collapsible into a housing with a diameter roughly the size of a tampon. In some embodiments, the inserter can be inserted into the vagina, and once the housing is retracted, the dilator can expand and push against the vaginal walls.

[0020] Compared to a digital vaginal exam (in which two fingers can be extended up to 10 cm), the device may require minimal distension, thereby minimizing discomfort.

[0021] In some embodiments, the measured data can be saved and accessed at any time, allowing tracking of labor progress. In some embodiments, the measured data can be uploaded to the hospital / clinic network to be saved under the patient's file.

[0022] Although the device may need to be used multiple times during labor to monitor the cervix, due to its improved accuracy compared to current vaginal examinations and the additional visual information it provides, it is expected that fewer measurements will be needed to track labor progress, thereby reducing the risk of infection and medical complications. It is also expected that unnecessary labor interventions can be minimized by basing decisions on accurate device measurements rather than potentially incorrect manually assessed parameters.

[0023] In situations where a vaginal exam is not possible, the disclosed device provides a solution because the device still operates intravaginally but does not have to make contact with the cervix (except for the optional measurement of cervical texture provided in some embodiments), thereby enabling information to be collected from a distance. This non-contact measurement also helps reduce the risk of infection in normal pregnancies.

[0024] It is expected that images and videos of the cervix captured by the device can be used to create a database to be used as teaching materials for universities and hospitals, and the scientific community can use this teaching material to further study cervical changes during pregnancy and childbirth.

[0025] Consistent with some disclosed embodiments, a device for providing cervical parameters and / or fetal parameters may include: an imaging device; an inserter configured to assist in inserting the imaging device into the vaginal canal for imaging the cervix and / or fetus; and a processor in data communication with the imaging device and configured to determine the cervical parameters and / or fetal parameters based on corresponding imaging of the cervix and / or fetus using machine vision.

[0026] In some embodiments, the device further comprises a flexible shaft attached at a distal end to the imaging device, wherein the processor is configured to manipulate the flexible shaft to align the imaging device. In some embodiments, the device further comprises a handle attached at a distal end to the shaft; wherein the processor is housed within the handle, wherein the handle comprises a controller for controlling the device.

[0027] In some embodiments, the device further comprises a monitor configured to display a GUI generated by the processor, the GUI comprising imaging captured by the imaging device, and cervical parameters and / or fetal parameters. In some embodiments, the inserter comprises a housing and a dilator, wherein the dilator is configured to fold into the housing and expand when pushed out of the housing, and wherein the dilator is sufficiently rigid to dilate the vaginal lumen.

[0028] In some embodiments, the cervical parameters are selected from the list consisting of cervical dilation, cervical effacement, and cervical texture. In some embodiments, the fetal parameters are selected from the list consisting of fetal position, vasa previa, placenta previa, and fetal presenting part height.

[0029] In some embodiments, the imaging device is selected from the group consisting of a 3D imaging device, a stereo camera, a LIDAR, a structured light scanner, an ultrasound scanner, a laser scanner, a camera, a single camera using a 2D depth map, a Doppler ultrasound scanner, and combinations thereof. In some embodiments, the imaging device includes a laser configured to target the edge of the cervix, wherein the processor is configured to display a virtual ruler on the GUI superimposed on an image of the cervix captured by the imaging device featuring light from the laser to enable measurement of cervical dilation.

[0030] In some embodiments, the 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 the GUI based on imaging from the imaging device.

[0031] 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 (LIF), Raman spectroscopy, or NIRS, and is further configured to use LIF, Raman spectroscopy, or NIRS to assess cervical texture. In some embodiments, the device further includes an elasticity sensor and is further configured to use the elasticity sensor to assess cervical texture. In some embodiments, the device is further configured to provide a visual / auditory indication that the image within the field of view of the imaging device is of sufficient quality to enable image analysis to be run or to capture an image or video. In some embodiments, the device is further configured to provide a visual / auditory indication that automatic capture of an image or video has begun.

[0032] Consistent with some disclosed embodiments, a method for providing cervical parameters and / or fetal parameters may include: providing the above-mentioned device; inserting a shell into the vaginal canal; expanding a dilator from the shell inserted into the vaginal canal; moving an imaging device through the shell and the dilator to capture images of the cervix and / or fetus; and determining, by a processor, cervical parameters and / or fetal parameters based on the corresponding imaging of the cervix and / or fetus.

[0033] Consistent with some disclosed embodiments, a method for providing cervical parameters and / or fetal parameters may include: providing the above-mentioned device; operating the device to capture imaging of the cervix and / or fetus via a transabdominal, transperineal or translabial manner; and determining, by a processor, the cervical parameters and / or fetal parameters based on the corresponding imaging of the cervix and / or fetus.

[0034] This summary is provided to introduce in simplified form selected concepts that may be further described below in the detailed description. It should be understood that this summary is not intended to identify key features or essential features of the present disclosure, nor is it intended to limit the scope of the present disclosure. Details of one or more embodiments disclosed herein are set forth in these drawings and the following description. Other features will become apparent from this description and the drawings and from the claims. BRIEF DESCRIPTION OF THE DRAWINGS

[0035] The following describes the non-limiting embodiments disclosed herein with reference to the drawings listed after this paragraph, and the same structures, elements or parts appearing in more than one drawing are generally marked with the same numbers in all drawings in which they appear. When similar reference numerals are shown, the corresponding (multiple) descriptions are not repeated, and the interested reader is referred to the (multiple) drawings discussed previously for a description of the similar (multiple) elements. The drawings and descriptions are intended to illustrate and clarify the embodiments disclosed herein, but should not be considered to be limiting in any way. In particular, changes and modifications that are obvious to those skilled in the art may be considered without departing from the scope of the claimed scope.

[0036] Figure 1A to Figure 1B is an illustration of a cervical measurement device according to some embodiments disclosed herein;

[0037] Figure 1C is a block diagram illustrating components of a cervical measurement device according to some embodiments disclosed herein;

[0038] Figure 2A A flow chart showing a process of using a cervical measurement device according to some embodiments disclosed herein;

[0039] Figures 2B to 2E A diagram illustrating the use of a cervical measurement device according to some embodiments disclosed herein. DETAILED DESCRIPTION

[0040] Figure 1A to Figure 1B is an illustration of a cervical measurement device 100 (hereinafter referred to as "device 100") according to some embodiments disclosed herein. Figure 1C is a block diagram illustrating components of a cervical measurement device 100 according to some embodiments disclosed herein. In some embodiments, the device 100 may include an imaging device 110 , a shaft 112 , a handle 114 , a monitor 116 , a processor 118 , and an inserter 120 .

[0041] In some embodiments, the imaging device 110 can be a 3D imaging device. In some embodiments, the imaging device 110 can include a stereo camera, a LIDAR, a structured light scanner, an ultrasound scanner, a laser scanner, a single camera using a 2D depth map, or a combination of any of these. In some embodiments, the imaging device 110 can include a light source for illumination. In some embodiments, the imaging device 110 can include a distance measuring laser. In some embodiments, the imaging device 110 can include Doppler capabilities. In some embodiments, the device 110 can include the ability to assess cervical texture, such as light induced fluorescence (LIF), Raman spectroscopy, near infrared imaging (NIRS), or an elastic sensor.

[0042] In some embodiments, the imaging device 110 is mounted on the distal end of a shaft 112. In some embodiments, the shaft 112 can have a diameter of 10 mm to 30 mm. In some embodiments, the shaft 112 can have a length of 15 cm to 30 cm. In some embodiments, the shaft 112 or a portion of the shaft can be flexible and / or steerable such that the shaft 112 can be flexed by a controller 115 on a handle 114 to align the imaging device 110 in a desired direction.

[0043] The handle 114 can be held by the practitioner when the device 100 is in use, and the handle can include a controller 115 on the proximal end of the handle 114. In some embodiments, the controller 115 can control the movement of the shaft 112 and the operation of the imaging device 110. In some embodiments, the controller 115 can include one or more buttons, a touch screen, or other interface components that enable the clinician to operate the device 100. In some embodiments, the handle 114 or another portion of the device 100 can include a power source (such as a battery) so that the device 100 can be used wirelessly.

[0044] The device 100 may include a processor 118, and the device may therefore be a computing device as defined herein. The processor 118, and the modules and components included in the device 100 may include or communicate with a non-transitory computer-readable medium (such as memory 119), which contains 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. The processor 118 may manage the operation of the components of the device 100 and may direct data flow between the components of the device 100. Where the device 100 is said herein to provide a particular function or perform an action, it should be understood that the function or action may be performed by the processor 118, which may call other components of the device 100. The processor 118 may be implemented by various types of processor devices and / or processor architectures, including, for example, embedded processors, communication processors, graphics processing units (GPUs), soft-core processors, and / or embedded processors. The processor may be in data communication with other components of the device 100 , such as the imaging device 110 , the axis 112 , the controller 115 , and / or the monitor 116 .

[0045] In some embodiments (such as Figure 2D ), the monitor 116 can be attached to the handle 114. In some embodiments, the monitor 116 can be separate from the handle 114. The monitor 116 can display a graphical user interface (GUI) generated by the processor 118. In some embodiments, the monitor 116 can include a human-machine interface component (such as a touch screen) through which a user can interact with the device 100 in addition to or instead of the controller 115.

[0046] In some embodiments, the apparatus 100 may include a communication module (not shown) for enabling transmission and / or reception of data (such as captured images and measurement results) optionally via a communication network.

[0047] In some embodiments, the device 100 can include an introducer / inserter 120 (herein "inserter 120"). In some embodiments, the inserter 120 includes a housing 122 and a dilator 124. In some embodiments, the housing 122 can have a cylindrical shape with a hollow central lumen that is larger than the diameter of the imaging device 110. In some embodiments, the housing 122 can have a diameter between 10 mm and 20 mm. In some embodiments, the inserter 120 can be a disposable sterile attachment into which the shaft 112 can be inserted before or after the inserter 120 is inserted into the vaginal lumen 134 ( Figure 2B ).

[0048] In some embodiments, the inserter 120 can have two configurations, namely, a collapsed / folded configuration in which the dilator 124 is folded into the housing 122, and an expanded / expanded configuration in which the dilator 124 is expanded from the housing 122. In some embodiments, the dilator is sufficiently strong to dilate the vaginal lumen 134 when the dilator 124 is pressed against the wall of the vaginal lumen 134 ( Figure 2B ).

[0049] In some embodiments, the dilator 124 can be collapsed along the longitudinal axis to a diameter small enough to fit inside the housing 122. In use, once the housing 122 is inserted into the vaginal lumen 134, the collapsed dilator 124 can be pushed out of the housing 122 and expanded to its full diameter, thereby pressing against the walls of the vaginal lumen 134 and dilating the vaginal lumen 134.

[0050] In some alternative embodiments, the inserter 120 may include an inflatable portion (not shown) attached to the outer surface of the dilator 124, which is inflated once the dilator 124 is pushed out of the housing 122 ( Figure 2B ), the inflatable portion will be inflated to apply pressure to the wall of the vaginal lumen 134, thereby causing vaginal dilation.

[0051] In use, the device 100 can be operated internally (intravaginally) or externally. For example, internal use can utilize both camera imaging and ultrasound, while external use can rely solely on ultrasound.

[0052] Figure 2A A flow chart illustrating a process 200 of using the apparatus 100 according to embodiments disclosed herein is shown. Figures 2B to 2E A diagram illustrating the use of the device 100 according to some embodiments disclosed herein for viewing the cervix 130 prior to birth of a fetus 132 after the device 100 is inserted into the vaginal lumen 134 .

[0053] The non-transitory computer-readable medium may contain instructions that, when executed by at least one processor, may perform the methods 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 the processor 118 and the memory 119 of the device 100 and / or other components of the device 100. The process 200 may utilize a machine learning process as defined herein.

[0054] for example Figure 2B As shown in FIG, in step 202, the clinician can insert the inserter 120 in its folded configuration into the vaginal canal 134 and can move the inserter 120 toward the cervix. Figure 2CAs shown in , in step 204, once in a position that will enable the imaging device 110 to capture a view of the cervix 130, the inserter 120 can be expanded (such as by pushing the dilator 124 out of the housing 122) so that the dilator presses against the walls of the vaginal lumen 134, thereby dilating the walls of the vaginal lumen 134.

[0055] for example Figure 2D , in step 206, the clinician may advance the shaft 112 through the inserter 120 and manipulate the shaft 112 (e.g., with the aid of the controller 115) until a view of the cervix 130 acquired by the imaging device 110 is shown on the monitor 116. In some embodiments, the inserter 120 may be further advanced into the vaginal lumen 134 to enable the shaft 112 to be further advanced into the vaginal lumen until a view of the cervix 130 acquired by the imaging device 110 is shown on the monitor 116.

[0056] In some embodiments, in step 208 , the view from imaging device 110 may be adjusted, including but not limited to adjusting the amount of light, focus, and zoom, for example, using a touch screen of controller 115 or monitor 116 .

[0057] for example Figure 2D and Figure 2E As shown in FIG, in step 210, the exterior and interior of the cervix 130 and the fetus 134 during pregnancy and labor can be imaged by the device 100 from inside or outside the vaginal lumen 134. As described above, the imaging device 110 can include, for example, a camera and an ultrasound scanner for capturing images and video of the exterior and interior of the cervix 130 and the fetus 134. Step 210 can include using the device 100 (such as via the controller 115) to capture images of the exterior and interior of the cervix 130 and the fetus 134 provided by the imaging device 110 and recording video. In some embodiments, the device 100 can be used outside the vaginal lumen 134 and steps 202 to 204 can be skipped. For example, where the imaging device 110 includes an ultrasound scanner, this can be used to capture images or video, as described below as part of step 210. In some embodiments, the device 100 can be used via a transabdominal, transperineal, or translabial approach.

[0058] In some embodiments, processor 118 can initiate the capture of images and videos by imaging device 110, then use machine vision techniques to automatically perform measurements related to the exterior and interior of cervix 130 and fetus 134, and present the results to the clinician via monitor 116. In some embodiments, measurements automatically performed by device 100 may include cervical dilation, cervical length (effecacy), fetal position, fetal presenting part height, conditions such as placenta previa and vasa previa, and cervical texture. In some embodiments, machine learning / machine vision algorithms can be trained to automatically segment and identify imaged anatomical structures (cervix, fetus), perform measurements, and display the results on monitor 116. In some embodiments, fetal presenting part height can be measured using machine vision using the ischial spines, pubic bone, or other bony structures and reported as a distance in centimeters. In some embodiments, fetal position can be analyzed by a machine learning algorithm, providing results in clinical terms. It will be appreciated that this approach can significantly simplify the effort required of the clinician, who only needs to perform steps 202 through 208, after which device 100 automatically provides a wide range of available information.

[0059] In some embodiments, step 210 may further include activating (automatically by the device 100 or by the clinician) a distance measuring component (such as a laser) of the imaging device 110 aimed at the edge of the cervix 130 to superimpose a virtual ruler on the monitor 116, thereby enabling real-time and accurate measurement of cervical dilation.

[0060] Additionally or alternatively, in some embodiments, a clinician can use the device 100 to perform size measurements on the captured images of the cervix 130. In some embodiments, the captured images or videos can be saved on the device 100 or uploaded to an external computing device (such as, but not limited to, a hospital network and a patient's data files). In some embodiments, the captured images and videos can be accessed for comparison with previous or future images acquired by the device 100 as labor progresses.

[0061] In some embodiments, the processor 118 may operate a 3D reconstruction algorithm to render the cervix in 3D on a screen based on the imaging from the imaging device 110 .

[0062] In some embodiments, an image measurement tool can be displayed on the monitor 116 to allow the clinician to manually measure different dimensions of the cervix, such as dilation and effluvium. In some embodiments, the imaging device 110 can provide a combination of ultrasound and structured light data (or any other optical method described above), which can be processed by the processor 118 to display information about the structure and dynamics of the cervix 130 and / or the position of the fetus 132 as labor progresses.

[0063] Steps 206 and 208 , or only step 206 or only step 208 , may be repeated for each image / video capture / analysis of step 210 .

[0064] In step 212, once step 210 has been completed, the device 100 can be withdrawn from the vaginal canal 134. In some embodiments, the inserter 120 can be collapsed to its smallest size configuration by retracting the dilator 124 into the housing 122 and then removed from the vaginal canal 134. The process 200 can be repeated as needed during birth (such as indicated by arrow 214) to monitor the cervix and fetus.

[0065] 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.

[0066] The disclosed embodiments include methods, systems, devices, and computer-readable media. They are used to provide technical solutions to the challenging technical problem of measuring cervical and fetal-related data before or during birth, and relate to a system for providing cervical dilation measurement, wherein the system has at least one processor (e.g., a processor, processing circuit, or other processing structure described herein). For ease of discussion, an example method is described below, and it should be understood that aspects of the example method are also applicable to systems, devices, and computer-readable media. For example, some aspects of such a method can 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 circuit system for performing logical operations on input data) to perform the example method. Other aspects of such a method can be implemented over a network (e.g., a wired network, a wireless network, or both a wired network and a wireless network).

[0067] As another example, some aspects of such a method can be implemented as an operation or program code in a non-transient computer-readable medium. The operation or program code can be performed by at least one processor. As described herein, a non-transient computer-readable medium can be implemented as any combination of hardware, firmware, software, or any medium capable of storing data that can be read by any computing device having a processor for performing the method or operation represented by the stored data. In the broadest sense, the example methods are not limited to specific physical or electronic instruments, but can be completed using many different instruments.

[0068] The embodiment of the method disclosed herein can be related to manually, automatically, or by a combination of manual and automatic execution or completion of some selected tasks or steps. In addition, according to actual instruments and equipment, some selected steps can 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, the selected steps can be implemented as a chip or circuit. As software or algorithm, the selected steps can be implemented as multiple software instructions, which are executed by a computer using any suitable operating system. In any case, the selected steps can be described as being executed by a data processor (such as a computing device for executing multiple instructions).

[0069] Although this disclosure refers to a "processor," "computing device," "computer," or "mobile device," it should be noted that any device optionally characterized by 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), server, distributed server, virtual server, cloud computing platform, cellular phone, IP phone, smart phone, smart watch, or PDA (personal digital assistant). Any two or more of such devices communicating with each other may form a "network" or "computer network."

[0070] To provide interaction with a user, the systems and techniques described herein can be implemented on a computer having a display device (an 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 pointing device (e.g., a mouse or trackball) through which the user can provide input to the computer. Other types of devices can also be used to provide interaction with the user; for example, the feedback provided to the user can be any form of sensory feedback (e.g., visual feedback, auditory feedback, or tactile feedback); and the input from the user can be received in any form, including sound, voice, or tactile input.

[0071] In some embodiments, the systems disclosed herein can be implemented on one or more servers or storage systems and / or services associated with an enterprise or corporate entity, including, for example, a file hosting service, a 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 network storage locker. In some embodiments, the systems disclosed herein can be provided in various deployment models, including but not limited to cloud-based hardware servers or virtual servers.

[0072] The memory may include one or more types of computer-readable storage media, such as transactional memory and / or long-term storage memory facilities, and may be used as file storage, document storage, program storage, and / or working memory. The latter may be in the form of, for example, static random access memory (SRAM), dynamic random access memory (DRAM), read-only memory (ROM), cache memory, or flash memory. As long-term memory, the memory may include, for example, volatile or non-volatile computer storage media, hard drives, solid-state drives, magnetic storage media, flash memory, and / or other storage facilities. Hardware memory facilities may, for example, store fixed sets of information (e.g., software code), including but not limited to files, programs, applications, source code, object code, and the like.

[0073] As used herein, the terms "machine learning," "machine vision," or "artificial intelligence" refer to the use of algorithms on a computing device that parse data, learn from the data, and then make decisions or generate data, where the decisions or generated data cannot be deterministically replicated (such as using deterministic directed software as is known in the art). In some embodiments, a machine learning algorithm (also referred to herein as a machine learning model or artificial intelligence) can be trained using training examples. Further, in some examples, training a machine learning algorithm using training examples can generate a trained machine learning algorithm, and the trained machine learning algorithm can be used to estimate outputs for inputs not included in the training examples. In some examples, a machine learning algorithm can have parameters and hyperparameters.

[0074] Although certain steps of a method are outlined herein as being performed by a particular module and other steps being performed by another module, this should in no way be construed as limiting.

[0075] It should be understood that where the claims or specification refer to "a" or "an" element, such reference should not be interpreted as meaning that there is only one of the element. In the specification and claims of this application, each of the verbs "comprise," "include," and "have," and their conjugations, are used to indicate that one or more objects of the verb are not necessarily a complete list of components, elements, or parts of the subject matter of the verb.

[0076] Although the present disclosure has been described in terms of certain embodiments and generally related methods, changes and permutations of these embodiments and methods will be apparent to those skilled in the art. The present disclosure is to be understood not to be limited by the particular embodiments described herein, but only by the scope of the appended claims.

Claims

1. A device for providing cervical parameters and / or fetal parameters, the device comprising: Imaging device; an inserter configured to assist in inserting the imaging device into the vaginal lumen for imaging the cervix and / or fetus; as well as A processor is in data communication with the imaging device and is configured to determine the cervical parameters and / or fetal parameters based on respective imaging of the cervix and / or fetus using machine vision.

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

3. The device of claim 2, further comprising a handle attached to the shaft at the distal end, wherein The processor is housed within 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 comprising the imaging captured by the imaging device and the cervical parameters and / or fetal parameters.

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

6. The device according to claim 1, wherein The cervical parameters are selected from the group consisting of: cervical dilation, cervical efflorescence, and cervical texture.

7. The device according to claim 1, wherein The fetal parameters are selected from the group consisting of: fetal position, vasa previa, placenta previa, and height of the fetal presenting part.

8. The device according to claim 1, wherein The imaging device is selected from the group consisting of: a 3D imaging device, a stereo camera, a LIDAR, a structured light scanner, an ultrasound scanner, a laser scanner, a camera, a single camera using a 2D depth map, a Doppler ultrasound scanner, and combinations thereof.

9. The device according to claim 1, wherein The imaging device includes a laser configured to target the edge of the cervix, wherein the processor is configured to display a virtual ruler on a graphical user interface (GUI) superimposed on an image of the cervix captured by the imaging device featuring light from the laser to enable measurement of cervical dilation.

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

11. The device according to 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 can include a light source for illumination.

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

14. The apparatus of claim 1, further comprising an elasticity sensor, and further configured to assess cervical texture using the elasticity sensor.

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

16. The apparatus of claim 15, further configured to provide a visual / audible indication that automatic capture of images or video has commenced.

17. A method for providing cervical parameters and / or fetal parameters, the method comprising: Providing a device according to any one of claims 1 to 16; inserting the housing into the vaginal lumen; expanding the dilator from the housing inserted into the vaginal lumen; as well as An imaging device is moved through the housing and the dilator to capture images of the cervix and / or fetus.

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

19. A method for providing cervical parameters and / or fetal parameters, the method comprising: Providing an apparatus as claimed in claims 1 to 16; manipulating the device via a transabdominal, transperineal, or translabial approach to capture images of the cervix and / or fetus; as well as The cervical parameters and / or fetal parameters are determined by the processor based on respective imaging of the cervix and / or fetus.

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