Devices and methods for cervical and fetal assessment during labor

Abstract

A device for providing cervical and / or fetal parameters includes an imaging device, an inserter configured to assist in insertion of 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 use machine vision to determine cervical and / or fetal parameters based on the imaging of the cervix and / or fetus, respectively.

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims the benefit of priority to U.S. Provisional Patent Application No. 63 / 480,992, filed January 23, 2023, the contents of which are incorporated herein by reference in their entirety.

[0002] Field The subject matter disclosed herein relates generally to obstetrics, and more specifically to cervical and fetal assessment before and during labor. [Background technology]

[0003] background Digital vaginal examination is the currently accepted method for measuring the cervix to determine the progress of labor. During the examination, the physician assesses cervical dilation, cervical effacement (thickness of the cervix; thinner the closer to labor), cervical consistency (softness of the cervix; softer the closer to labor), cervical position (posterior or anterior), and the station and position of the newborn. To perform the examination, the physician inserts two fingers into the woman's vagina and palpates the cervix and surrounding areas. Often, the examination can be repeated multiple times at the end of pregnancy and during labor and can be performed by different physicians.

[0004] Digital vaginal examinations have several potential drawbacks. The passage of bacteria from the vagina into the cervix can increase the chance of infection for both the mother and the newborn, and this risk can increase with each additional examination. Furthermore, due to the nature of the examination, it may provide an assessment rather than an accurate measurement of the above parameters. In the case of cervical dilation assessments, it has been found to be inaccurate 50% of the time, with an error of up to 20%. Furthermore, the examination is subjective and highly dependent on the physician's level of expertise. For example, in 40% of cases, the same physician repeating the examination may obtain different dilation results, and different physicians 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 physician to refuse / refuse to perform the examination, threatening the mother and / or child. Furthermore, in 20% of cases, such as in high-risk pregnancies, placenta previa, and premature rupture of membranes, vaginal examinations cannot be used due to the higher risk of infection and bleeding.

[0005] During a vaginal exam, a physician may use a speculum to spread and support the vaginal walls and to gain visual access to the cervix. Because speculums are made of metal or hard plastic, many women report discomfort when used during a vaginal exam.

[0006] Cervical dilation is considered a key parameter for assessing the progress of labor. It provides information on which decisions for many labor interventions, including induction, cesarean section, and amniotomy, can be based. However, currently, no technical solution is available that can objectively and accurately measure cervical dilation. Due to the subjective nature of the test and its high error rate, it can lead to erroneous emergency surgical interventions and dangerously prolonged labor, or it can cause inaccurate medication administration in the event of a misdiagnosis of preterm labor.

[0007] Ultrasound may occasionally be used, but ultrasound technology is user-dependent and requires a high level of expertise to interpret ultrasound images. Devices for screening for cervical cancer, such as optical colposcopy, are not designed to, and cannot, measure cervical dilation and effacement, fetal position and station during labor. Summary of the Invention [Problem to be solved by the invention]

[0008] Therefore, there is a need for devices and methods for assessing the cervix and fetus during labor without the need for a digital vaginal exam. [Means for solving the problem]

[0009] overview In various embodiments, medical devices and methods of use are provided for measuring cervical dilation and effacement and for assessing the station and position of a newborn, and conditions such as vasa previa and placenta previa. Thus, rather than relying on subjective examination by a physician, which has high rates of intra- and inter-observer variability, the devices can provide accurate measurements independent of the physician performing the measurements.

[0010] In some embodiments, the device may include an imaging device mounted on a flexible and / or steerable shaft and operated within the vagina to capture images and video of the external and internal cervix and the fetus. In some embodiments, the device includes a monitor displaying a graphical user interface (GUI) that can present captured images and video, allowing automated or physician-assisted measurement 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 stereoscopic camera, laser scanner, LIDAR, structured light, depth maps from 2D images, or a combination thereof. 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 operate outside the vaginal canal, e.g., transabdominally, transperineally, or translabially, to provide complementary ultrasound images and quantitative data of the cervix and fetus. In some embodiments, the device may use the Doppler effect to help detect conditions such as placenta previa and vasa previa. In some embodiments, the device may include the ability to assess cervical firmness, for example, light-induced fluorescence (LIF), Raman spectroscopy, near-infrared imaging (NIRS), or an elasticity sensor.

[0011] In some embodiments, 3D capabilities and machine learning (ML) algorithms may enable extraction of dimensional and qualitative information about 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 and provide dimensional and qualitative information related to the cervix and / or fetus to the device user.

[0012] In some embodiments, the device may provide a visual / audible indication that the image within its field of view is of sufficient quality to perform a successful image analysis, as well as to inform the operator to take a snapshot and / or record a video.

[0013] In some embodiments, the device may provide a visual / audible indication that the image within its field of view is of sufficient quality to perform successful image analysis, as well as to inform the operator that automatic capture of snapshots and / or video recordings has begun.

[0014] In some embodiments, the imaging device may include a camera and a laser to emit laser light diagonally relative to the axis of the camera, such that the position of the laser beam on the cervix varies with 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.

[0015] In some embodiments, a laser may be used as an aiming beam on the tissue, allowing the user to identify locations of interest in real time. In some embodiments, a software algorithm built into the device can use the laser spot on the tissue as a mark and display a virtual ruler superimposed on the image, with the ruler's scale varying depending on the distance of the imaging device to the cervix. In some embodiments, with the virtual ruler superimposed on the image, the physician can measure (on a monitor) the cervical dilation.

[0016] In some embodiments, the acquired images and videos, along with the measurement data, may be recorded and stored in a patient file to be accessed as labor progresses. In some embodiments, a set of software measurement tools may be provided for the physician to use to determine point / line-to-point / line distance, area, diameter and thickness measurements on the acquired images and 3D renderings, thereby measuring cervical dilation and effacement.

[0017] 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 dilate and support the vaginal walls in a manner that provides the imaging device with a line of sight to the cervix. The vaginal canal is essentially a collapsible tube at the end of which the cervix resides, and the inserter provides a more comfortable alternative to, for example, a colposcope.

[0018] In some embodiments, the inserter can include a narrow cylindrical channel no wider than a tampon (e.g., 15-20 mm) that can contain a dilator that is expanded within the vagina to expand and support the vaginal walls. In some embodiments, the dilator can be collapsible / foldable into a housing, approximately the size of a tampon in diameter. In some embodiments, the inserter can be inserted into the vagina, and when the housing is pulled back, the dilator can expand and push against the vaginal walls.

[0019] In contrast to digital vaginal exams, where the spread of two fingers reaches 10 centimeters, the device may require minimal extension, thereby minimizing the level of discomfort.

[0020] In some embodiments, the measured data can be stored and accessed at any time, allowing tracking of the progress of labor, hi some embodiments, the measured data can be uploaded to a hospital / clinic network to be stored in the patient's file.

[0021] Although the device may need to be used multiple times during labor to monitor the cervix, due to its greater accuracy compared to current vaginal exams and the additional visual information it provides, it is expected that fewer measurements will be needed to track the progress of labor, thereby reducing the risk of infection and medical complications. It is also expected that unnecessary labor interventions may be minimized, basing decisions on accurate device-measured data rather than potentially inaccurate manually assessed parameters.

[0022] When vaginal testing is not possible, the disclosed device provides a solution as it still operates intravaginally but does not require contact with the cervix (except for the optional measurement of cervical firmness provided in some embodiments), allowing for the collection of information from a distance. This non-contact measurement helps reduce the risk of infection even in normal pregnancies.

[0023] It is anticipated that cervical images and videos captured by the device may be used to generate databases that serve as educational materials in universities and hospitals that can be used by the scientific community to further study cervical changes during pregnancy and labor.

[0024] Consistent with certain disclosed embodiments, a device for providing cervical and / or fetal parameters may include an imaging device, an inserter configured to assist in insertion of the imaging device into the vaginal canal for imaging of the cervix and / or fetus, and a processor in data communication with the imaging device and configured to use machine vision to determine cervical and / or fetal parameters based on the imaging of the cervix and / or fetus, respectively.

[0025] In some embodiments, the device further includes a flexible shaft having an imaging device attached to a distal end thereof, and the processor is configured to guide the flexible shaft to aim the imaging device. In some embodiments, the device further includes a handle having the shaft attached to a distal end thereof, the processor is housed within the handle, and the handle includes a controller for controlling the device.

[0026] In some embodiments, the device further includes a monitor configured to display a GUI generated by the processor, the GUI including imaging acquired by the imaging device and cervical and / or fetal parameters. In some embodiments, the inserter includes a housing and a dilator configured to fold into the housing and to expand when pushed out of the housing, the dilator being rigid enough to widen the vaginal canal.

[0027] In some embodiments, the cervical parameter is selected from a list including cervical dilation, cervical effacement, and cervical consistency, hi some embodiments, the fetal parameter is selected from a list including fetal position, vasa previa, placenta previa, and fetal station.

[0028] In some embodiments, the imaging device is selected from the group consisting of a 3D imaging device, a stereoscopic 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 of the above. In some embodiments, the imaging device includes a laser configured to be aimed at the edge of the cervix, and the processor is configured to display, in the GUI, a virtual ruler superimposed on an imaging device-acquired image of the cervix featuring light from the laser to enable measurement of cervical dilation.

[0029] In some embodiments, the captured images or videos are stored 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 in a GUI based on the imaging from the imaging device.

[0030] 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 assess cervical firmness using LIF, Raman spectroscopy, or NIRS. In some embodiments, the device further includes an elasticity sensor and is further configured to assess cervical firmness using the elasticity sensor. In some embodiments, the device is further configured to provide a visual / audio 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. In some embodiments, the device is further configured to provide a visual / audio indication that automatic image or video capture has begun.

[0031] Consistent with certain disclosed embodiments, a method for providing cervical and / or fetal parameters may include providing the device described above, inserting the housing into the vaginal canal, expanding the dilator out of the housing and into the vaginal canal, moving an imaging device through the housing and the dilator to obtain images of the cervix and / or fetus, and determining, by a processor, the cervical and / or fetal parameters based on the images of the cervix and / or fetus, respectively.

[0032] Consistent with certain disclosed embodiments, a method for providing cervical and / or fetal parameters may include providing the device described above; activating the device transabdominally, transperineally, or translabially to obtain imaging of the cervix and / or fetus; and determining, by a processor, the cervical and / or fetal parameters based on the imaging of the cervix and / or fetus, respectively.

[0033] This Summary is provided to introduce a selection of concepts in a simplified form that may be further described below in the Detailed Description. It can 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. Details of one or more embodiments disclosed herein can be set forth in the accompanying drawings and the description that follows. Other features will be apparent from the description and drawings, and from the claims.

[0034] BRIEF DESCRIPTION OF THE DRAWINGS Non-limiting embodiments disclosed herein are described below with reference to the accompanying drawings listed following this paragraph. Identical structures, elements, or portions that appear in more than one figure are generally designated with the same numeral in all figures in which they appear. Where similar reference numerals are shown, the corresponding description will not be repeated and the interested reader is referred to the previously discussed figures for descriptions of similar elements. The drawings and description are intended to facilitate and clarify the understanding of the embodiments disclosed herein, but should not be considered limiting in any way. In particular, changes and modifications obvious to those skilled in the art may be contemplated without departing from the scope of the claims. [Brief explanation of the drawings]

[0035] [Figure IA] 1 is a diagram of a cervical measurement device according to an embodiment disclosed herein; [Figure lB] FIG. 10 is a diagram of a cervical measurement device according to another embodiment disclosed herein. [Figure 1C] FIG. 1 is a block diagram illustrating components of a cervical measurement device according to some embodiments, as disclosed herein. [Figure 2A] 1 shows a flow diagram of a process for use of a cervical measurement device according to some embodiments disclosed herein. [Figure 2B] 1 shows an illustration of the use of a cervical measurement device according to an embodiment disclosed herein. [Figure 2C] 10 shows a diagram of the use of a cervical measurement device according to another embodiment disclosed herein. [Figure 2D] 10 shows a diagram of the use of a cervical measurement device according to another embodiment disclosed herein. [Figure 2E] 10 shows a diagram of the use of a cervical measurement device according to another embodiment disclosed herein. DETAILED DESCRIPTION OF THE INVENTION

[0036] Detailed Description 1A-1B are diagrams of a cervical measurement device 100 (hereinafter "device 100") according to some embodiments disclosed herein. FIG. 1C is a block diagram illustrating components of cervical measurement 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.

[0037] 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, ultrasound scanner, laser scanner, a single camera using a 2D depth map, or any combination thereof. 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 a Doppler effect. In some embodiments, device 110 may include the capability to assess cervical firmness, such as induced fluorescence (LIF), Raman spectroscopy, near-infrared imaging (NIRS), or an elasticity sensor.

[0038] In some embodiments, imaging device 110 is attached to the tip 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 a portion thereof, may be flexible and / or steerable such that shaft 112 may be controlled by controller 115 on handle 114 to bend to aim imaging device 110 in a desired direction.

[0039] The handle 114 may be held by a physician during use of the device 100 and may include a controller 115 at a proximal end of the handle 114. In some embodiments, the controller 115 may control the movement of the shaft 112 and the operation of the imaging device 110. In some embodiments, the controller 115 may include one or more buttons, a touchscreen, or other interface components that allow the physician to operate the device 100. In some embodiments, the handle 114 or another part of the device 100 may include a power source (e.g., a battery) so that the device 100 may be used wirelessly.

[0040] Device 100 may include processor 118, and thus may be a computing device as defined herein. Processor 118 and the modules and components included in device 100 may include or be in communication with a non-transitory computer-readable medium (e.g., memory 119) containing instructions configured to perform functions and / or operations necessary to provide the functionality described herein when executed by at least one processor (e.g., processor 118). 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. When device 100 is said to provide particular functionality or perform operations herein, it is understood that the functionality or operations may be performed by processor 118 that may require the use of other components of device 100. Processor 118 may be implemented by various types of processor devices and / or processor architectures, including, for example, an embedded processor, a communications processor, a graphics processing unit (GPU), a soft-core processor, and / or a built-in processor. The processor may be in data communication with other components of the device 100, such as the imaging device 110, the shaft 112, the controller 115, and / or the monitor .

[0041] In some embodiments (as shown in FIG. 2D ), the monitor 116 may be attached to the handle 114. In some embodiments, the monitor 116 may be separate from the handle 114. The monitor 116 may display a graphical user interface (GUI) generated by the processor 118. In some embodiments, the monitor 116 may include a human interface component, such as a touchscreen, by which a user may interact with the device 100 in conjunction with or as an alternative to the controller 115.

[0042] In some embodiments, device 100 may optionally include a communications module (not shown) to enable transmission and / or reception of data (eg, captured images and measurements) over a communications network.

[0043] 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 in diameter than imaging device 110. In some embodiments, housing 122 may have a diameter of 10-20 mm. In some embodiments, inserter 120 may be a disposable, sterile attachment into which shaft 112 may be inserted before or after insertion of inserter 120 into vaginal canal 134 (FIG. 2B).

[0044] In some embodiments, the inserter 120 can have two configurations: a collapsed / folded configuration in which the dilator 124 is collapsed into the housing 122, and an expanded / expanded configuration in which the dilator 124 expands out of the housing 122. In some embodiments, the dilator is sufficiently rigid so as to widen the vaginal canal 134 (FIG. 2B) when the dilator 124 presses against the walls of the vaginal canal 134.

[0045] In some embodiments, the dilator 124 can be collapsed along its longitudinal axis to a diameter small enough to fit inside the housing 122. During use, when the housing 122 is inserted into the vaginal canal 134, the collapsed dilator 124 can be pushed out of the housing 122 and expanded to its full diameter, thus pressing against the walls of the vaginal canal 134 and widening it.

[0046] In some alternative embodiments, the inserter 120 may include an expandable portion (not shown) attached to the outside of the dilator 124 that can expand when the dilator 124 is pushed out of the housing 122 inside the vaginal canal 134 (FIG. 2B) and exerts pressure on the walls of the vaginal canal 134, thus creating vaginal expansion.

[0047] In use, device 100 can be operated internally (transvaginally) or externally. For example, internal use may utilize camera imaging and ultrasound, while external use may rely solely on ultrasound.

[0048] Figure 2A shows a flow diagram of a process 200 for use of device 100 according to embodiments disclosed herein. Figures 2B-2E show an illustration of the use of device 100 to view cervix 130 after insertion of device 100 into vaginal canal 134 before the birth of fetus 132, according to some embodiments disclosed herein.

[0049] The non-transitory computer-readable medium may include instructions that, when executed by at least one processor, may perform the methods and operations described in one or more of the steps in process 200. The non-transitory computer-readable medium and the at least one processor may correspond to processor 118 and memory 119 of device 100, and / or one or more of other components of device 100. Process 200 may utilize machine learning processes defined herein.

[0050] In step 202, the physician may insert the inserter 120 into the vaginal canal 134 in its collapsed configuration and move the inserter 120 toward the cervix, as shown in, for example, Figure 2B. In step 204, once in a position that allows the imaging device 110 to obtain a view of the cervix 130, as shown in Figure 2C, the inserter 120 may be expanded, for example, by pushing the dilator 124 out of the housing 122, such that the dilator presses against the walls of the vaginal canal 134, thereby widening the walls of the vaginal canal 134.

[0051] 2D , the physician may push shaft 112 through inserter 120 and manipulate shaft 112 (e.g., with controller 115) until the view of cervix 130 acquired by imaging device 110 is displayed on monitor 116. In some embodiments, inserter 120 may be pushed further into vaginal canal 134 to allow shaft 112 to be pushed further into the vaginal canal until the view of cervix 130 acquired by imaging device 110 is displayed on monitor 116.

[0052] In some embodiments, in step 208, the view from the 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 on the controller 115 or monitor 116.

[0053] In step 210, the exterior and interior of the cervix 130 and fetus 134 during pregnancy and labor may be imaged from within the vaginal canal 134 or externally by device 100, as shown, for example, in FIGS. 2D and 2E . As described above, imaging device 110 may include, for example, a camera and an ultrasound scanner for capturing images and video of the exterior and interior of the cervix 130 and fetus 134. Step 210 may include using device 100 (e.g., via controller 115) to obtain images and record video of the exterior and interior of the cervix 130 and fetus 134 provided by imaging device 110. In some embodiments, device 100 may be used external to the vaginal canal 134, and steps 202-204 may be omitted. For example, if imaging device 110 includes an ultrasound scanner, it may be used to capture images or video as described below as part of step 210. In some embodiments, device 100 may be used transabdominally, transperineally, or translabially.

[0054] In some embodiments, the processor 118 can initiate image and video capture by the imaging device 110 and then use machine vision technology to automatically perform measurements related to the exterior and interior of the cervix 130 and fetus 134 and recommend results to the physician via the monitor 116. In some embodiments, measurements automatically performed by the device 100 can include cervical dilation, cervical length (effacement), fetal position, fetal station, conditions such as placenta previa and vasa previa, and level of cervical consistency. In some embodiments, machine learning / machine vision algorithms can be trained to automatically segment and identify the imaged anatomical structures (cervix, fetus) and perform measurements and display them on the monitor 116. In some embodiments, fetal station can be measured using machine vision with respect to the ischial spine or pubic bone or other bony structures and reported as distance in centimeters. In some embodiments, fetal position can be analyzed by a machine learning algorithm and results provided in clinical terms. It should be appreciated that such an approach can significantly simplify the effort required by a physician who only needs to perform steps 202-208 before device 100 operates to automatically provide widely available information.

[0055] In some embodiments, step 210 may further include activating (by device 100 or automatically by the physician) a distance measurement component (e.g., a laser) of imaging device 110 aimed at the edge of cervix 130 to enable real-time accurate measurement of cervical dilation by overlaying a virtual ruler on monitor 116.

[0056] Additionally or alternatively, in some embodiments, a physician may use device 100 to perform dimensional measurements on captured images of cervix 130. In some embodiments, captured images or videos may be stored on device 100 or uploaded to an external computing device (such as, but not limited to, a hospital network and patient data files). In some embodiments, captured images and videos may be accessed for use in comparison with previous or future images taken by device 100 during the progress of labor.

[0057] In some embodiments, the processor 118 may run a 3D reconstruction algorithm to present the cervix in 3D on the screen based on imaging from the imaging device 110 .

[0058] In some embodiments, image measurement tools may be displayed on monitor 116 to allow the physician 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 to display information about the structure and mechanics of cervix 130 and / or the position of fetus 132 as labor progresses.

[0059] Steps 206 and 208 or only step 206 or only step 208 may be repeated for each image / video acquisition / analysis in step 210 .

[0060] At step 212, once step 210 is completed, device 100 may be withdrawn from the vaginal canal 134. In some embodiments, inserter 120 may be collapsed to its minimum size configuration by withdrawing dilator 124 into housing 122 prior to removal from the vaginal canal 134. Process 200 may be repeated throughout labor (e.g., as indicated by arrow 214) as needed to monitor the cervix and fetus.

[0061] 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 are not intended to be limiting.

[0062] Disclosed embodiments include methods, systems, devices, and computer-readable media. The present disclosure relates to a system for providing a technical solution to the challenging technical problem of measuring cervical and fetal related data before or during labor and for providing cervical dilation measurements in a system having at least one processor (e.g., a processor, processing circuit, or other processing structure described herein). To facilitate discussion, exemplary methods are described below with the understanding that aspects of the exemplary methods also apply 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. A computing device may include at least one processor (e.g., a CPU, GPU, DSP, FPGA, ASIC, or any electrical circuitry for performing logical operations on input data) to perform the exemplary methods. Other aspects of such methods may be implemented over a network (e.g., a wired network, a wireless network, or both).

[0063] As another example, some aspects of such methods may be implemented as operations or program code on a non-transitory computer-readable medium. The operations or program code may be executed by at least one processor. A non-transitory computer-readable medium as described herein may be implemented as hardware, firmware, software, or a combination of any medium capable of storing data that can be read by any computing device with a processor to perform the methods and operations represented by the stored data. In the broadest sense, the exemplary methods are not limited to any particular physical or electronic means, but rather may be accomplished using many different means.

[0064] Implementations of the methods disclosed herein may involve performing or completing certain selected tasks or steps manually, automatically, or a combination thereof. Furthermore, depending on the actual means and apparatus, some selected steps may be implemented by hardware (HW) or by software (SW) of any operating system, any firmware, or a combination thereof. For example, as hardware, selected steps may be implemented as a chip or circuit. As software or an algorithm, selected steps may be implemented as software instructions executed by a computer using any suitable operating system. In either case, selected steps may be described as being performed by a data processor, e.g., a computing device for executing instructions.

[0065] It should be noted that while this disclosure refers to a "processor," "computing device," "computer," or "mobile device," optionally, any device 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, mobile phone, IP phone, smartphone, smart watch, or PDA (personal digital assistant). Any two or more such devices in communication with each other may form a "network" or "computer network."

[0066] To provide for user interaction, the systems and techniques described herein may be implemented on a computer having a display device (such as an LED (light emitting diode), or OLED (organic LED), or LCD (liquid crystal display) monitor / screen) for displaying information to the user, a keyboard, and a pointing device (e.g., a mouse or trackball) by which the user may provide input to the computer. Other types of devices may be used to provide for user interaction as well; for example, feedback provided to the user may be any form of sensory feedback (e.g., visual feedback, auditory feedback, or tactile feedback), and input from the user may be received in any form, including auditory, spoken, or tactile input.

[0067] In some embodiments, the systems disclosed herein may be implemented in one or more server or storage systems and / or services associated with a business or corporation, 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 cyberlocker. In some embodiments, the systems disclosed herein may be provided in a variety of deployment models, including, but not limited to, cloud-based, hardware server, or virtual.

[0068] Memory may include one or more types of computer-readable storage media, including, for example, transactional memory and / or long-term memory facilities, and may function 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, or flash memory. As long-term memory, memory may include, for example, volatile or non-volatile computer storage media, hard disk drives, solid-state drives, magnetic recording media, flash memory, and / or other storage facilities. Hardware memory facilities may store fixed sets of information (e.g., software code), including, for example, but not limited to, files, programs, applications, source code, object code, etc.

[0069] As used herein, the terms "machine learning," "machine vision," or "artificial intelligence" refer to the use of algorithms on a computing device to analyze data, learn from the data, and then make decisions or generate data, where the decisions or generated data are not deterministically replicable (e.g., with deterministically oriented software known in the art). In some embodiments, a machine learning algorithm (also referred to herein as a machine learning model or artificial intelligence) may be trained using training examples. Furthermore, in some examples, training a machine learning algorithm using training examples can produce a trained machine learning algorithm, which can be used to predict outputs for inputs not included in the training examples. In some examples, a machine learning algorithm may have parameters and hyperparameters.

[0070] Although certain method steps are outlined herein as being performed by particular modules, and other steps by other modules, this should not be construed as limiting in any way.

[0071] When a claim or the specification refers to "a" or "an" element, it should be understood that such reference is not to be construed as indicating that there is only one of that element. In the description and claims of this application, the verbs "comprise," "include," and "have," as well as their conjugations, are used to indicate that the object or objects of the verb are not necessarily an exhaustive list of the components, elements, or parts of the object of the verb.

[0072] While this disclosure has been described with respect to particular embodiments and generally associated methods, modifications and rearrangements of the embodiments and methods will be apparent to those skilled in the art. It is understood that the disclosure is not limited to the particular embodiments described herein, but rather only by the scope of the appended claims.

Claims

1. 1. A device for providing cervical and / or fetal parameters, comprising: An imaging device; an inserter configured to assist insertion of the imaging device into the vaginal canal for imaging of the cervix and / or fetus; 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; Including, the device.

2. 10. The device of claim 1, wherein the device further comprises a flexible shaft having the imaging device attached to a distal end thereof, and wherein the processor is configured to guide the flexible shaft to aim at the imaging device.

3. 3. The device of claim 2, wherein the device further comprises a handle having the shaft attached to a distal end thereof, the processor housed within the handle, and the handle including a controller for controlling the device.

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

5. 10. The device of claim 1, wherein the inserter includes a housing and a dilator configured to fold into the housing and to expand when pushed out of the housing, the dilator being rigid enough to widen the vaginal canal.

6. 10. The device of claim 1, wherein the cervical parameter is selected from the group consisting of cervical dilation, cervical effacement, and cervical consistency.

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

8. 10. The device of claim 1, wherein the imaging device is selected from the group consisting of a 3D imaging device, a stereoscopic 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. 10. The device of claim 1, wherein the imaging device includes a laser configured to be aimed at the edge of the cervix, and the processor is configured to display in a graphical user interface (GUI) a virtual ruler superimposed on an image acquired by the imaging device of the cervix featuring light from the laser to enable measurement of cervical dilation.

10. The device of claim 1 , wherein captured images or videos are stored 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 in 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. 10. The device of claim 1, wherein the device is further configured to provide light-induced fluorescence (LIF), Raman spectroscopy, or near-infrared imaging (NIRS), and further configured to assess cervical firmness using the LIF, Raman spectroscopy, or NIRS.

14. The device of claim 1 , wherein the device further comprises an elasticity sensor and is further configured to assess cervical firmness using the elasticity sensor.

15. The device of claim 1 , further configured to provide a visual / audio 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 device of claim 15 , further configured to provide a visual / audio indication that automatic image or video capture has begun.

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

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

19. 1. A method for providing cervical and / or fetal parameters, comprising: Providing a device according to any one of claims 1 to 16; actuating the device transabdominally, transperineally, or translabially to obtain an image of the cervix and / or fetus; determining, by the processor, the cervical and / or fetal parameters based on the respective imaging of the cervix and / or fetus; A method comprising:

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