WO2025137718A1

WO2025137718A1 - Systems and devices for practicing performance of cervical procedures and methods of use thereof

Info

Publication number: WO2025137718A1
Application number: PCT/US2024/061791
Authority: WO
Inventors: Donald J. LEE; Amelia M. Degenkolb; Lauren Martin
Original assignee: Novocuff Inc
Current assignee: Novocuff Inc
Priority date: 2023-12-22
Filing date: 2024-12-23
Publication date: 2025-06-26
Anticipated expiration: 2026-06-22
Also published as: WO2025137719A1

Abstract

Preterm birth stemming from short cervix and/or cervical failure is the leading cause of infant mortality globally. The cerclage is a useful intervention to help support the tissue of a short and/or failing cervix so that it may remain closed until a later point in fetal development, thereby extending fetal gestational period and, at times, preventing preterm birth. This cerclage procedure is effective but training and practice performing the procedure it is difficult to due to a lack of proper training models. Disclosed herein are different embodiments of model cervixes and methods of use that provides users (with a model on which to practice performance of cervical procedures under various simulated, or modeled, conditions (e.g., cervical anatomy, degree of lubrication, protruding amniotic sac, etc.). The model cervixes disclosed herein may have adjustable component(s) and/or may utilize material that is closely representative of the anatomical cervix under various conditions.

Description

SYSTEMS AND DEVICES FOR PRACTICING PERFORMANCE OF CERVICAL PROCEDURES AND METHODS OF USE THEREOF

RELATED APPLICATION

[0001]This application is an INTERNATIONAL (PCT) application of, and claims priority to United States Provisional Patent Application Number: 63/614,468, filed on 22 December 2023 and entitled “SYSTEMS AND DEVICES FOR PRACTICING PERFORMANCE OF CERVICAL PROCEDURES AND METHODS OF USE THEREOF,” which is incorporated herein by reference.

FIELD OF USE

[0002]This application generally relates to medical devices, systems, and methods for use. In particular, the application pertains to model cervixes and other systems and devices upon which to practice performance of cervical procedures.

BACKGROUND

[0001] A cervical cerclage is an obstetric procedure that is performed to strengthen the integrity of the cervix and prolong labor to ultimately prevent preterm birth. It involves sewing the cervix shut using a stitch and can be performed using various techniques. The most common technique is the McDonald cerclage, where a suture is inserted into the cervix, stitched in a purse-string pattern, and tied off with a knot in the anterior or posterior region of the cervix. Emergency cerclages are occasionally placed when fetal membranes (e.g., the amniotic sack) are protruding out of the patient’s dilated cervix and involve tucking the protruded membrane back into the cervix and carefully performing the cerclage so as to not rupture the fetal membrane. Highly skilled obstetricians trained in performing cerclage procedures are scarce, especially in healthcare deserts and areas isolated from hospitals specializing in maternal care.

SUMMARY

[0002] Disclosed herein is a model cervix and optional accessories that may be used and, in some cases, reused as a training device upon which a user may practice performance of one or more types of cervical procedures including, but not limited to, suturing, cerclage and emergency cerclage (e.g. a cerclage performed when the amniotic sac is protruding from the cervical os). Optional accessories for the model cervix include, but are not limited to, insert(s) with various properties configured to mimic various anatomical cervixes, sensors configured to measure, for example, force, pressure, and/or movement of the model cervix and/or a portion thereof, and mounting hardware such as brackets and stands that facilitate positioning of the model cervix on, for example, a tabletop for easy access. In some embodiments, the sensor(s) may be a FlexiForce sensor that is covered and/or protected by a housing configured to cooperate with an internal cavity of the model cervix. Another optional accessory is a vaginal sheath that may be configured to mimic spatial restrictions within the vaginal canal experienced by clinicians when performing a procedure on the cervix.

[0003] In some embodiments, the model cervix may include reinforcing material and/or features that, for example, prevent tearing, failure, and/or disintegration during use and/or following suturing. This reinforcing material may contribute to the life-like feel of the model cervix and may also allow the model cervix to be used for performance of repeated procedures without failure.

[0004]The model cervixes disclosed herein may include a base and an extension projecting from the base. The model cervixes may be made from, for example, silicone, rubber, plastic, vinyl and/or combinations thereof. At times, the model cervixes disclosed herein may be manufactured all in one piece via, for example, injection or other molding processes.

[0005] In some embodiments, the base may be configured to cooperate with mounting hardware to be mounted to a stand. The extension may be configured to approximate anatomical features of cervical tissue and, on some occasions, may include a reinforcing component configured to maintain structural integrity of the extension when the extension is repeatedly sutured, cut, compressed, bent, tilted, or otherwise used. [0006]ln some embodiments, the model cervixes disclosed herein may feature (e.g., an opening or indent) positioned on an end of the extension not in communication with the base and the opening may be configured to approximate an external cervical os.

[0007] Add itionally, or alternatively, in some embodiments, the model cervixes disclosed herein may include one or more internal chambers configured to hold fluid (e.g., gas, water, saline, hydrogel, etc.) and/or a soft (e.g., Shore durometer value of 0, 00, or 000 and/or hardness scale A) polymer (e.g., silicone) chosen so as to, for example, approximate the feel and response to force of anatomical cervical tissue and or tissue proximate to a cervix. For the sake of brevity, the fluid and/or polymer may be collectively referred to herein as “fluid”. At times, internal chamber may be filled with fluid and a portion of the internal chamber may be defined by an expandable wall segment configured to expand to accommodate displacement of fluid within the internal chamber that may be caused by, for example, movement, tilting, suturing, and/or compression of the model cervix and/or a portion thereof (e.g., the extension).

[0008] In some embodiments, the chamber may reside in an interior portion of the base and/or the extension. Additionally, or alternatively, in some embodiments the model cervixes disclosed herein may include a membrane separating a first portion of the chamber from a second portion of the chamber. At times, the first portion may reside in the base and the second portion may reside in the extension. The membrane may be configured to expand or deform responsively to fluid displacement within the first portion of the chamber or the second portion of the chamber. Additionally, or alternatively, in some embodiments, the model cervixes disclosed herein may include a channel resident within the body and configured to approximate a blood vessel.

[0009] In some embodiments, the model cervixes disclosed herein may include an opening positioned on an end of the extension not in communication with the base, the opening being configured to approximate an external cervical os and a channel that is open to the opening and extends from the opening through the extension and a portion of the base. The channel may be defined by a channel wall of approximately uniform thickness or a channel wall of approximately varying thicknesses, wherein a thickness of a first portion of the channel wall extending through the extension is less than a thickness of a second portion of the channel wall extending through a portion of the base. At times, the thickness of the first portion of the channel wall is configured to enable compression of the extension. In some embodiments, fluid may be placed within the channel so that a user may practice performance of a procedure on the model cervix while limiting emission of the fluid from the central channel in a manner that approximates limiting or eliminating leakage of amniotic fluid from the model cervix/channel.

[00010] Exemplary systems disclosed herein may include a model cervix and a vaginal sheath comprising a sidewall defining a cavity that is configured to approximate vaginal anatomy and accept insertion of the model cervix therein. The sheath may further include an opening configured to allow user access to the extension of the model cervix. In some embodiments, a portion of the sidewall may be configured to fit over the base, thereby holding the vaginal sheath in place relative to the model cervix. In some instances, the system may further include mounting hardware configured to mount an assembly of the model cervix and the vaginal sheath.

[00011] Additionally, or alternatively, exemplary systems disclosed herein may include a model cervix and a sensor configured to sense a condition of the model cervix. The sensor may be a motion sensor, an accelerometer, a gyroscope, a pressure meter, a pressure transducer, and/or a force and/or force flex sensor. For example, the sensor may be a force or pressure sensor configured to measure compression of the extension or base, a gyroscope and/or accelerometer configured to measure an orientation of the model cervix or the extension. The sensor may be positioned within a cavity of the model cervix.

BRIEF DESCRIPTION OF THE DRAWINGS

[00012] FIG. 1A provides a top perspective view of an exemplary model cervix, in a manner consistent with some embodiments disclosed herein;

[00013] FIG. 1 B provides a cross-section view of the exemplary model cervix of FIG. 1A in a manner consistent with some embodiments disclosed herein;

[00014]FIG. 1C provides a cut-away view of the exemplary model cervix of FIG. 1A, [00015] FIG. 2A provides a cross-section view of a system including the model cervix of FIGs. 1A-1C and an insert positioned within an internal cavity of the model cervix, in a manner consistent with some embodiments disclosed herein;

[00016] FIG. 2B provides a cross section view of the system of FIG. 2A, in a manner consistent with some embodiments disclosed herein; [00017] FIG. 2C provides a bottom perspective view of the system of FIG. 2A, in a manner consistent with some embodiments disclosed herein;

[00018] FIG. 3A provides a side perspective view of a first or second model cervix that includes a chamber, in a manner consistent with some embodiments disclosed herein; [00019] FIG. 3B provides a cross section view of the first model cervix with chamber of FIG. 3A, in a manner consistent with some embodiments disclosed herein;

[00020]FIG. 3C provides a cross section view of the second model cervix with chamber of FIG. 3A, in a manner consistent with some embodiments disclosed herein;

[00021] FIG. 4A provides a side perspective view of a first or second model cervix that includes a chamber and an internal channel, in a manner consistent with some embodiments disclosed herein;

[00022] FIG. 4B provides a cross section view of the first model cervix that includes a chamber and an internal channel of FIG. 4A, in a manner consistent with some embodiments disclosed herein;

[00023]FIG. 4C provides a cross section view of the second model cervix that includes a chamber and an internal channel of FIG. 4A, in a manner consistent with some embodiments disclosed herein;

[00024] FIG. 5A provides a perspective view of an exemplary vaginal sheath, in a manner consistent with some embodiments disclosed herein;

[00025] FIG. 5B provides a side view of the exemplary vaginal sheath of FIG. 5A, in a manner consistent with some embodiments disclosed herein;

[00026] FIG. 6A provides a perspective view of a bracket configured for attachment to, and cooperation with, the model cervix of FIGs. 1A-1C, in a manner consistent with some embodiments disclosed herein;

[00027] FIG. 6B provides a top view of the bracket of FIG. 6A, in a manner consistent with some embodiments disclosed herein;

[00028]FIG. 6C provides a bottom view of the bracket of FIG. 6A, in a manner consistent with some embodiments disclosed herein;

[00029] FIG. 6D is a cross-section of an assembly of a model cervix, the vaginal sheath of FIG. 5A, and the bracket of FIG. 6A; [00030] FIG. 7A provides an exploded view of an assembly the model cervix of FIGs. 1A-1C, the vaginal sheath of FIGs. 5A and 5B, the bracket of FIGs. 6A-6C, a sensor housing, and a sensor, in a manner consistent with some embodiments disclosed herein;

[00031] FIG. 7B provides a cross-section view of a portion of the assembly of FIG. 7A without the vaginal sheath, in a manner consistent with some embodiments disclosed herein;

[00032] FIG. 7C provides a cross-section perspective view of a portion of assembly of FIG. 7A that does not include the bracket, in a manner consistent with some embodiments disclosed herein;

[00033] FIG. 8A is a diagram of a first system that includes an assembly of mounting hardware that is coupled to an assembly of the bracket of FIGs. 6A-6C and the model cervix of FIGs. 1A-1C, 3A-3C, or 4A-4C, in a manner consistent with some embodiments disclosed herein;

[00034]FIG. 8B is a diagram of a second system that includes the assembly of FIG. 8A and the vaginal sheath of FIGs. 5A and 5B positioned over the model cervix of FIGs. 1A-1C, 3A-3C, or 4A-4C, in a manner consistent with some embodiments disclosed herein;

[00035] FIG. 8C is a diagram of the second system of FIG. 8B with a cross-section view of the assembly of the vaginal sheath of FIGs. 5A and 5B and the model cervix of FIGs. 1A-1C, 3A-3C, or 4A-4C, in a manner consistent with some embodiments disclosed herein;

[00036] FIG. 8D is a diagram of a third system that includes mounting hardware and the model cervix of FIGs. 1A-1C, 3A-3C, or 4A-4C, in a manner consistent with some embodiments disclosed herein;

[00037] FIG. 9 is a side perspective view of an assembly of a stand and the model cervix of FIGs. 1A-1C, 3A-3C, or 4A-4C, in a manner consistent with some embodiments disclosed herein;

[00038] FIG. 10 is a flow diagram of an exemplary process for setting up and using the model cervix of FIGs. 1A-1C, 3A-3C, or 4A-4C, in a manner consistent with some embodiments disclosed herein; [00039] FIG. 11A is a diagram of a user using the model cervix of FIGs. 1A-1C, 3A-3C, or 4A-4C and a sensor to practice a cerclage procedure, wherein a cross-section view of the model cervix is provided by the figure, in a manner consistent with some embodiments disclosed herein;

[00040] FIG. 11 B is a diagram of a top view of the user using the model cervix of FIGs. 1A-1C, 3A-3C, or 4A-4C to practice a cerclage procedure, in a manner consistent with some embodiments disclosed herein;

[00041] FIG. 12 is a flow diagram of an exemplary process for setting up and using a model cervix to practice performance of an emergency cervical procedure upon a cervical model from which a portion of an amniotic sack is protruding from an os, in a manner consistent with some embodiments disclosed herein;

[00042] FIG. 13A is a first diagram of a user executing the process of FIG. 12, in a manner consistent with some embodiments disclosed herein;

[00043]FIG. 13B is a second diagram of a user executing the process of FIG. 12, in a manner consistent with some embodiments disclosed herein;

[00044] FIG. 14 is a block diagram of an exemplary system configured to execute one or more processes described herein, in a manner consistent with some embodiments disclosed herein; and

[00045] FIG. 15 provides a flowchart of an exemplary process for receiving and/or analyzing data received from one or more sensors, in a manner consistent with some embodiments disclosed herein.

WRITTEN DESCRIPTION

[00046] Preterm birth stemming from short cervix and/or cervical failure is the leading cause of infant mortality globally. The cerclage is a useful intervention to help support the tissue of a short or otherwise insufficient or failed cervix so that it may remain closed until a later point in fetal development, thereby extending the gestational period for the fetus and, in some cases, preventing preterm birth. While the cerclage procedure is effective, it is difficult, if not impossible, to practice performing the procedure except in clinic and for high-risk pregnancies due to a lack of proper training models and materials. Anatomical training models are essential in familiarizing physicians with the cerclage and other cervical procedures and increasing their skill and confidence in correctly performing these procedures prior to performing them on a patient especially within the confines of the vaginal canal proximate to the cervix and in high-risk pregnancy situations.

[00047]The present invention is directed to systems and devices that include a model cervix and methods of their use that provide users (e.g., medical personnel, students, residents, and/or nurses) with a training model cervix on which to practice performance of the cerclage procedure and/or other cervical procedures under various simulated, or modeled, conditions (e.g., cervical anatomy, degree of lubrication, protruding amniotic sac, etc.). In many embodiments, the model cervixes disclosed herein may have one or more adjustable components and/or may utilizes material that is closely representative of and/or approximates the anatomical cervix under various conditions.

[00048]Turning now to the figures, FIG. 1A provides a top perspective view, FIG. 1 B provides a cross-section view, and FIG. 1C provides a cut-away view of an exemplary model cervix 100 that includes a base 130, an extension 110 that approximates anatomical and/or physical attributes (e.g., size, shape, texture, density, deformation characteristics, and/or shear stress tolerance) of an anatomical cervix and tissue proximate to a cervix, a cervical opening, or os, 120 that approximates an anatomical cervical os, a cervix/base interface 115 positioned where base 130 meets extension 110, and an internal cavity 140 (seen in FIGs. 1 B and 1C). As may be seen in, for example, FIG. 1 B, model cervix 100 includes an outer shell, or body, 135 that may be manufactured to provide tactile feedback to a user that approximates that of an anatomical cervix. In different embodiments, cervical os 120 may range in size to, for example, approximate an undilated (e.g., 1-2.5mm), partially dilated (e.g., 1-3 or 2-6cm) and/or fully dilated (e.g., 8-10cm) cervix.

[00049] In some embodiments, model cervix 100 may include one or more sensors 180 positioned, for example within a sidewall or component of model cervix 100 and/or on an exterior and/or interior surface thereof. In the embodiment of model cervix 100 shown in FIGs. 1A-1C, model cervix includes a first sensor 180 embedded within a sidewall of body 130 and a second sensor 180 positioned on an exterior surface (e.g., the surface facing into the page of FIGs. 1 B and 1C) of extension 110 but, a model cervix may include any number of sensors 180 within and/or coupled to a portion thereof. Sensor 180 may be configured to sense, or measure, one or more actions taken upon model cervix 100 during, for example, performance of cerclage practice. Sensor 180 may be embodied as, for example, a motion sensor, an accelerometer, a gyroscope, a pressure meter, a pressure transducer, a force, a moisture sensor, and/or force flex sensor.

[00050] In some embodiments, sensor(s)180 may be in communication with an external device (e.g., computer or receiver) that may be configured to collect and/or analyze measurements or other data collected by sensor 180. This communication may be done via a wired and/or wireless communicative coupling. Additionally, or alternatively, sensor 180 may include a memory configured to, for example, store one or more measurements for later downloading and/or access by, for example, a computer and/or processor running a software program configured to receive data from sensor 180 and, is some cases, analyze the received data. Additionally, or alternatively, sensor 180 may include a wireless transceiver or other communication interface configured to wirelessly communicate data to, for example, an external computing device (e.g., a computer and/or processor) as, for example, described herein (see e.g., FIG. 14).

[00051]

[00052]0uter shell 135 may be configured to approximate the feel and response of anatomical tissue and, in some embodiments, outer shell 135 may comprise a soft and flexible material, such as silicone, and may have a Shore A scale rating ranging from, for example, 7A to 70A, with a preferred durometer within a range of 20A-40A and/or have a thickness within a range of 0.002-0.02 inches, 0.004-0.010 inches, or 0.02-0.1 inches. . Additionally, or alternatively, outer shell 135 may comprise a shelf lubricating polymer, such as self-lubricating silicone, in order to represent and/or approximate, for example, the lubricious nature of the cervix in situ.

[00053]As may be seen in FIGs. 1 B and 1C, extension 110 includes a reinforcing component 125 positioned between the interior and exterior surfaces of extension 110. Reinforcing component 125 may comprise, for example, a woven mesh and/or a reinforcing feature (e.g., ring, column, and/or set of distinct features) configured to provide structural integrity that may allow for repeated suturing and, at times, removal of sutures and re-suturing of extension 110 in a manner that may be consistent with practicing performance of a cerclage procedure without failure (e.g., tearing, disintegration, and/or ripping). Exemplary materials for reinforcing component include, but are not limited to polymers, fabric, mesh, and/or metal. Reinforcing feature 125 may be present along a portion (as shown in FIGs. 1 B and 1C) and/or an entire length of extension 110 and/or model cervix 100.

[00054] In some embodiments, model cervix may include an internal component that is cast into outer shell 135, positioned within, and/or inserted into internal cavity 140 to, for example, provide rigidity, weight, and/or simulate a tactile response of an anatomical cervix under various conditions. FIG. 2A is a cross-section of a system 201 that includes model cervix 100 and an interior component 210 positioned within internal cavity 140. In some embodiments, interior component 210 may comprise materials (e.g., silicon or container of saline) configured to have a durometer that causes system 201 to mimic one or more cervical characteristics (e.g., hardness, flexibility, thickness, etc.) so that, for example, the user may practice performance of a cerclage procedure on model cervixes with different anatomical characteristics. For example, interior component 210 may comprise a silicone material that is on the Shore 00 scale so that system 201 may mimic a soft, or compromised, cervical hardness level. In some embodiments, interior component 210 may include a channel 220 which may be configured to accept insertion of, for example, one or more sensors and/or fluids therein.

[00055]At times, outer shell 135 may include one or more channels 245 as shown in the cross-section of cervical model 202 provided by FIG. 2B. Channels 245 may be configured to approximate (e.g., size and/or position) blood vessels within cervical tissue. In these embodiments, the channels 245 may be filled with a fluid that approximates blood to, for example, provide visual and/or tactile feedback (e.g., fluid leakage from channel 245 when they have punctured and/or cut the channel/modeled vessel) to a user of where vessels may be located and/or when the user has punctured a vessel via practicing a cerclage procedure using model cervix 100. One or more channels 245 may also be present that port to, for example, outer shell 135 and these channels may allow for lubricant to be dispensed to coat model cervix 100 during use. Once a material such as artificial blood and/or lubricant is placed within one or more channel(s) 245, an opening to the respective channel 245 may be sealed with a plug 240 as shown in FIG. 2B and the exploded view of FIG. 2C, wherein plugs 240 are aligned with openings to channels 245 and then are inserted therein as shown in FIG. 2B. In some embodiments, plugs 240 may be one-way valves (e.g., a duckbill valve) that enable a user to insert fluid via insertion of, for example, a nozzle or needle, but then seals the opening following extraction thereof. Additionally, or alternatively, one, or both plugs 240 may include and/or be coupled to a sensor 180.

[00056] FIG. 3A provides a side perspective view of a first or second model cervix that includes a chamber 301 or 302. First and second model cervixes with chamber 301 and 302 include a base 330, an extension 310 (similar to extension 110) that approximates anatomical and/or physical attributes (e.g., size, shape, texture, density, deformation characteristics, and/or shear stress tolerance) of an anatomical cervix, a cervical opening, or os, 320 (similar to os 120) that approximates an anatomical cervical os, a cervix/base interface 315 (similar to cervix/base interface 115) positioned where base 330 meets extension 310, and a channel 340 that encircles base 330 may be configured to, for example, cooperate with mounting hardware as, for example, disclosed herein.

[00057]As may be seen in the cross-section of FIG. 3B, first model cervix with chamber 301 includes a chamber 350 that may be filled with any appropriate fluid and/or gel including, but not limited to, gas, air, water, saline, a hydrogel, and/or a soft (e.g., Shore durometer value of 0, 00, or 000 and/or hardness scale A) polymer (e.g., silicone) chosen so as to, for example, approximate the feel and response to force of anatomical cervical tissue and or tissue proximate to a cervix. For the sake of brevity, the fluid and/or polymer may be collectively referred to herein as “fluid”. Chamber 350 and the fluid contained therein may be configured to assist first model cervix with chamber 301 to approximate the feel, consistency, and/or rigidity of an anatomical cervix and/or surrounding tissue. On some occasions, an amount and/or type of fluid present within chamber 350 may be varied to, for example, alter the feel, consistency, and/or rigidity of first model cervix with chamber 301 in a manner that may represent anatomical cervixes with corresponding differences in feel, consistency, and/or rigidity. First model cervix with chamber 301 also includes an expandable wall segment 345 positioned at the base of the first model cervix with chamber 301 . Expandable wall segment may be configured to deform, or expand, thereby for fluid to be displaced from chamber 350 when, for example, pressure is exerted directly, or indirectly, upon chamber 350. For example, in some embodiments, when first model cervix with chamber 301 is compressed, the fluid held within chamber 350 may be displaced by budging out of expandable wall segment 345, thereby allowing displacement of fluid within chamber 350. Expansion of expandable wall segment 345 may be accomplished by, for example, dimensions (e.g., width) that are relatively thin compared to other walls defining chamber 350.

[00058]ln some embodiments, dimensions (e.g., thickness and/or size (e.g., circumference or width)) of expandable wall segment 345 may be varied to, for example, approximate cervixes of varying stiffness. For example, a relatively thin (e.g., 0.003-0.0065 inches) expandable wall segment 345 may allow more liquid to be displaced from internal liquid-filled chamber 350 in response to pressure exerted upon first model cervix with chamber 301 than a relatively thick (e.g., 0.0065-0.12 inches) expandable wall segment 345 and, in this way, the thin expandable wall segment 345 may approximate a soft cervix while a thicker expandable wall segment 345 may approximate a firmer cervix. Although expandable wall segment 345 is shown at the base of first model cervix with chamber 301, this need not always be the case. For example, an expandable wall segment may be present proximate to os 320 and/or project from a side of base 330. FIG. 3B also shows an optional bottom chamber 335 that may be configured to provide space into which expandable wall segment 345 may expand without pushing first model cervix with chamber 301 away from mounting hardware, a base, and/or table upon which it rests or is positioned.

[00059] In some embodiments, first model cervix with chamber 301 may include an optional plug 365 that is configured to provide access to chamber 350 to, for example, add and/or subtract fluid therefrom. In some embodiments, optional plug 365 may be a removable plug that, once removed, provides access to an orifice by which fluid may be added and/or subtracted from chamber 350. Additionally, or alternatively, optional plug 356 may be a valve (e.g., a duckbill valve) that, once opened, provides access to an orifice by which fluid may be added and/or subtracted from chamber 350 using, for example, a syringe or tube.

[00060]Second model cervix that includes a chamber 302 has all the components of first model cervix that includes a chamber 301 with the exception that chamber 350 is divided into a first chamber 350A (housed within extension 310) and a second chamber 350B (housed within base 330) by a membrane 325 that separates the first and second chambers 350A and 350B. Membrane 325 may be configured to allow for fluid displacement from extension 310 by, for example, expanding toward base 330 and/or allow for fluid displacement from base 330 by, for example, expanding toward extension 310. Membrane 325 may be made from, for example, fabric, rubber, and/or silicone. [00061] In some embodiments, first and/or second model cervix that includes a chamber 301 and/or 302 may include one or more sensors 180. For example, first model cervix that includes a chamber 301 may include a sensor 180 within fluid filled chamber 350 and/or within a sidewall of body 330 and/or extension 310 as, for example, shown in FIG. 3B. Additionally, or alternatively, second model cervix that includes a chamber 302 may include a sensor 180 within first and/or second chambers 350A and/or 350B and/or within a sidewall of body 330 and/or extension 310 as, for example, shown in FIG. 3C. [00062] FIG. 4A provides a side perspective view of a first or second model cervix that includes a chamber and an internal channel 401 or 402. First and second model cervixes with the chamber and internal channel 401 and 402 include a base 430 (similar to base 130), an extension 410 (similar to extension 110) that approximates anatomical and/or physical attributes (e.g., size, shape, texture, density, deformation characteristics, and/or shear stress tolerance) of an anatomical cervix, a cervical opening, or os, 420 (similar to os 120) that approximates an anatomical cervical os, a cervix/base interface 415 (similar to cervix/base interface 115) positioned where base 430 meets extension 410, and a circumferential channel 440 (similar to channel 330) that may be configured to, for example, cooperate with mounting hardware as, for example, disclosed herein.

[00063]As may be seen in the cross-section of FIG. 4B, first model cervix with chamber and internal channel 401 includes a chamber 450 that may be filled with any appropriate fluid and/or gel including, but not limited to, gas, air, water, saline, and/or a hydrogel. Chamber 450 and the fluid contained therein may be configured to assist first model cervix with chamber and an internal channel 401 to approximate the feel, consistency, and/or rigidity of an anatomical cervix and/or surrounding tissue. First model cervix with chamber and internal channel 401 also includes an expandable wall segment 445 positioned at the base of the first model cervix with chamber and internal channel 401 , which allows for fluid to be displaced from chamber 450 when, for example, pressure is exerted directly, or indirectly, upon chamber 450. For example, in some embodiments, when first model cervix with chamber and internal channel 401 is compressed, the fluid held within chamber 450 may be displaced by budging out of expandable wall segment 445 in a manner similar to that of expandable wall segment 345, thereby allowing displacement of fluid within chamber 450.

[00064] In some embodiments, first model cervix with chamber and internal channel 401 may include an optional plug 465 that is configured to provide access to chamber 450 to, for example, add and/or subtract fluid therefrom in a manner similar to how optional plug 365 works with chamber 350 in a manner similar to plug 365.

[00065] First model cervix includes a chamber and internal channel 401 also includes a channel lumen 455 that extends from os 420 to expandable wall segment 340 and may be open at one or both ends. Channel lumen 455 may be defined by a channel wall 425 that may be approximately uniform in thickness along its length as shown in the cross-section of FIG. 4B. Channel wall 425 and/or channel lumen 455 may be configured to allow for placement of fluid therein that may approximate amniotic fluid so that, for example, a user may practice execution of procedures on model 401 that reduce and/or prevent leaking of this fluid from channel lumen 455 by, for example, sewing extension 410 closed and/or applying a technique (e.g., suturing and/or compression) that applies a posterior tilt to extension 410 to, for example, reduce a leak rate of the fluid from channel lumen 455.

[00066]FIG. 4C provides a cross-section of second model cervix that includes a chamber and internal channel 402, which includes the same components as model cervix that includes a chamber and internal channel 401 with the exception of a modified channel wall. As shown in FIG. 4B, channel wall 425 of first model cervix that includes a chamber and internal channel 401 is approximately uniform along its length. However, the channel wall of model 402 has two sections: a first section 425A, which extends from os 420 to approximately half-way through channel lumen 455 is thinner (e.g., 0.002-0.04 inches) than a second section 425B, which extends from an opening in expandable wall segment 445 to meet first section 425A and is thicker (e.g., 0.03-0.1 inches) than first section 425A. First segment 425A may be configured so that it collapses when extension 410 is compressed, which may allow for approximation of cervical compression caused by a cervical control device and/or system that fits over extension 410 to hold os 420 closed in a procedure to mimic that of holding the cervix closed to prevent pre-term birth and/or treat premature rupture of membranes (PROM) or pre-term premature rupture of membranes (PPROM).

[00067] In some embodiments, first and/or second cervix that includes a chamber and internal channel 401 and/or 402 may include one or more sensors 180 placed in a manner similar to that shown and described above with model cervix 100 (see e.g., FIGs. 2B and 2C.

[00068] FIGs. 5A and 5B provide perspective and side views, respectively, of an exemplary vaginal sheath 500 configured to approximate the dimensions and feel of a vagina proximate to the cervix. Vaginal sheath 500 includes a body 510 with a hollow cavity 540 therein. Vaginal sheath 500 also includes a proximal end 530 configured to interface with base 130 and accept insertion of a portion of base 130 therein and a distal end 520 that approximates a vaginal opening (e.g., 1-3 inches in diameter), or introitus, as if retractors or surgical tools were in place to create a larger opening. Distal end 520 may be, for example, round, oval, or elliptical in shape. In some embodiments, vaginal sheath 500 may comprise a compliant material such as, but not limited to, silicone. Vaginal sheath 500 may range from, for example, 10 to 50 durometer on the Shore A scale. In some embodiments, vaginal sheath 500 may include one or more rigid structure(s) therein and/or thereon that may be configured to, for example, mimic bone and/or other anatomical landmarks. Optionally, vaginal sheath 180 may include one or more sensors embedded in and/or attached to an exterior and/or interior (e.g., facing cavity 540) surface. The sensors may be configured to, for example, sense moisture within cavity 540 as may occur when artificial amniotic fluid is leaking from channel 455 and/or artificial blood is leaking from channel 245. Additionally, or alternatively, sensor 180 when coupled to/within vaginal sheath 500 may measure forces and/or stretching of vaginal sheath to, for example, provide feedback to a user that they are, or are not, able to perform a cervical procedure without exerting force upon the vaginal wall that may exceed a patient’s pain tolerance.

[00069]FIGs. 6A-6C provide perspective, top, and bottom views, respectively, of a bracket 600 configured for attachment to and cooperation with model cervix 100 and, in particular, proximal end of base 130. As may be seen in FIGs. 6A and 6B, bracket 600 includes a base plate 610 from which three tabs 630 extend. Tabs 630 are configured to engage with and hold an exterior surface of base 130 of cervical model 100 as described herein and shown in, for example, FIG. 7A. Bracket 600 also includes a coupling 620 sized, shaped, and configured to be inserted into and engage with cavity 140 of model cervix 100 as shown in, for example, FIG. 6D, which is a cross-section of an assembly 601 of model cervix 100, vaginal sheath 500, and bracket 600. Bracket 600 also includes an opening 640 through which cables or other devices may extend. Opening 640 also provides access to the base of assembly 601 and/or an assembly of model cervix 100 and vaginal sheath 500. The bottom view of FIG. 6C shows support structures 660 for base plate 610 as well as an aperture 650 configured to couple to, for example, a mounting device as disclosed herein. When assembled as, for example, shown in FIG. 6D, a distance between distal end of extension 110 and distal end 520 of vaginal sheath 500 may be, for example, 1-5 inches and, in some cases, may be 1 .5- 2.5 inches.

[00070] FIG. 7A provides an exploded view of an assembly 700 of model cervix 100, interior component 210 (not shown), vaginal sheath 500, bracket 600, a sensor housing 710, and a sensor 180. FIG. 7B provides a cross-section view of a portion of assembly 700B without vaginal sheath that shows how interior component 210 is positioned within a distal end cavity 140, sensor housing 710 is positioned within channel 220, coupling 620 is positioned within a proximal end of cavity 140, bracket 600 is positioned at the base of model cervix 100, a tab 630 is positioned on an outside surface of, and engaged with, outer shell 135, and sensor 180 extends from sensor housing 710, through opening 640 and outside of bracket 640. FIG. 7C provides a cross-section perspective view of a portion of assembly 700C that does not include bracket 600 and shows how assembly 700 may be prepared prior to affixing an assembly of model cervix 100, interior component 210, sensor housing 710, and sensor 180 to bracket 600.

[00071] In the embodiment of FIG. 7A, sensor 180 may be sized, shaped, and configured so that it may be inserted through a proximal end of model cervix 100 and interior component 210 and reside within channel 220 as shown in FIGs. 7B and 7C. In some embodiments, sensor housing 710 may be a protective casing configured to prevent unwanted damage to sensor 180 from, for example, a suture needle passing through extension 110. Additionally, or alternatively, sensor 180 may have a rigid or protective layer so that use of a protective housing like housing 710 is not necessary. Sensor 180 may be in communication with an external device (e.g., computer or receiver) that may be configured to collect and/or analyze measurements or other data collected by sensor 180.

[00072] At times, an assembly of bracket 600 and model cervix 100 and/or an assembly of bracket 600, interior component 210, sensor housing 710, and model cervix 100 may be attached to mounting hardware configured to allow a user to conveniently use same without risk of unintentional movement while practicing performance of a cervical (e.g., cerclage) procedure. The mounting hardware may attach the assembly to, for example, a bench or tabletop, and/or provide a base by which the assembly may rest upon a surface. At times, the mounting hardware may comprise one or more mechanical components configured and arranged to allow for adjusting an orientation of model cervix 100 and/or an assembly of components including model cervix 100.

[00073] FIG. 8A is a diagram of an exemplary system 801 that includes an assembly of mounting hardware 810 that is coupled to an assembly of bracket 600 and model cervix 100. Assembly of mounting hardware 810 includes an upper arm 811 coupled to a lower arm 807 via an adjustable and/or articulating hinge 812, which may be embodied as a Hirth joint. Hinge 812 may be configured to allow a relative angle between upper arm 811 and lower arm 807 to be adjusted according to, for example, user preference to, for example, approximate a position and/or orientation of a patient’s cervix.

Assembly of mounting hardware 810 also includes a top plate 804 with an opposing threaded level mount 805 configured to allow anchoring of assembly of mounting hardware 810 to a board, table, or bench via a threaded wing nut. Additionally, or alternatively, in some embodiments, assembly of mounting hardware 810 may include a clamp, a quick release clamp, and/or motorized clamp. A horizontal extension 806 may extend from upper arm 811 and its position (e.g., height) on upper arm 811 may be adjustable using a clamp or screw mechanism as, for example, shown in FIGs. 8A-8C. [00074]FIG. 8B is a diagram of another exemplary of system 802 that includes assembly of mounting hardware 810 along with an assembly of bracket 600, vaginal sheath 500, and cervical model 100 (not shown) and FIG. 8C is a cross section of system 802 that shows how cervical model 100 is positioned within vaginal sheath 500 when attached to bracket 600 and assembly of mounting hardware 810.

[00075] In other embodiments, an assembly of model cervix 100, bracket 600, and optionally vaginal sheath 500 may be mounted to hardware with base configured to rest on a table without a clamp, an example of which is provided by FIG. 8D, which is a diagram of system 803. System 803 includes mounting hardware 811 , which includes upper arm 811 , hinge 812, and a base 620 configured to be placed on a working surface and hold assembly of bracket 600 and model cervix 100 as shown. Base 620 may be configured so that, for example, it relies on weight, friction, and/or suction, to hold the remainder of system 803 in place during use.

[00076] FIG. 9 is a side perspective view of an assembly of one of the cervical models 100, 201 , 202, 301 , 302, 401 , or 402 mounted on a stand 910 that includes a base 920 and a platform 930. Stand 910 may be made from any acceptable material or combination of materials including, but not limited to, plastic, metal, and wood. On some occasions, cervical model 100, 201 , 202, 301 , 302, 401 , or 402 may be affixed and/or mounted to stand 910 via mounting hardware like bracket 600. Additionally, or alternatively, cervical model 100, 201 , 202, 301 , 302, 401 , or 402 may be affixed and/or mounted to stand 910 via a projection from platform 930 (not shown) configured to cooperate with a cavity like cavity 140 or cervix/base interface like cervix/base interface 315 or 415.

[00077] FIG. 10 is a flow diagram of an exemplary process 1000 for setting up and/or using a model cervix like the model cervixes disclosed herein so that, for example, a user may practice performance of a cervical procedure and/or cerclage as shown in, for example, FIGs. 11A and 11 B. [00078] Initially, in step 1005, a sensor like sensor 180 may be set up for use. In some embodiments, execution of step 1005 may include turning the sensor(s) on, pairing it/them with a computing device (e.g., smart phone, tablet, laptop computer, etc. such as computing device 1420 shown in FIG. 14 and discussed below), positioning the sensor(s) on or within a model cervix and/or system including a model cervix, and/or calibrating the sensor(s). Then, the sensor may be coupled to the model cervix (step 1010) as, for example, shown in FIGs. 7A, 7B, and/or 7C. Additionally, or alternatively, execution of step 1010 may include attaching the sensor to a surface of the model cervix and/or a vaginal sheath (e.g., vaginal sheath 500) used with the model cervix. Optionally, in step 1015, a vaginal sheath (e.g., vaginal sheath 500) may be placed over the model cervix as, for example, shown in FIG. 7C and the model cervix (with the sensor), an assembly of the model cervix and the sensor, and/or an assembly of the model cervix, sensor, and vaginal sheath may be optionally affixed to mounting hardware (step 1020) such as mounting hardware 810, 811 , 806, and/or stand 910 as, for example, shown in FIGs. 8A-8C and 9. Optionally, in step 1025, a position and/or orientation of the model cervix, an assembly of the model cervix and the sensor, and/or an assembly of the model cervix, sensor, and vaginal sheath may be adjusted via, for example, adjusting a height and/or orientation of mounting hardware 810, 806, and/or 811 fix, for example, articulating hinge 812. Optionally, in step 1030, a user may add fluid to a channel of the model cervix. Execution of step 1030 may include adding blood-approximating fluid (e.g., water, saline, artificial blood, etc.) to one or more channels 245 so that, for example, the user may practice performance of a cervical procedure with a model cervix that includes blood vessels, wherein the user may practice performance of the procedure without disrupting the blood-approximating fluid within the channel as would be desirable in a clinical situation. Additionally, or alternatively, execution of step 1030 may include adding a fluid that approximates, or models amniotic fluid (e.g., saline, water, etc.) to a central channel (e.g., channel 455) of the cervical model so that the user may practice cervical procedures (e.g., cervical compression or tilting) designed to restrict and/or stop the flow of amniotic fluid from the cervix. [00079]Then, the user may begin using the model cervix, an assembly of the model cervix and the sensor, and/or an assembly of the model cervix, sensor, and vaginal sheath to practice performance of one or more cervical procedures (e.g., cerclage, change of cervical orientation, cervical compression, etc.) (step 1030). In some embodiments, execution of step 1030 may include performance of a cerclage procedure as shown in FIGs. 11A and 11 B, wherein a user 1105 is practicing performance of a cerclage procedure by suturing a portion of extension 110 of model cervix 100 in a purse-string pattern by moving forceps 1120 holding a suture 1110 as shown in FIGs. 11 A and 11 B. FIGs. 11A and 11 B also show how user 1105 may practice performance of the cerclage procedure on extension 110 within the confines of cavity 540 of vaginal sheath 500 and FIG. 11A further shows how sensor 180 and sensor housing 710 may be positioned within model cervix 100 during use to, for example, sense force exerted thereon and/or sense motion and/or moisture of, or proximate to, the cervical model. Data and/or measurements collected by sensor (s)180 may be communicated to an external computing device (step 1040) for further analysis and/or processing to, for example, provide feedback to user 1105 regarding his or her performance of the cerclage on the model cervix. See FIG. 15 and the discussion of process 1500 for more details regarding execution of step 1040.

[00080] In some embodiments, not all steps of process 1000 may be performed as may be the case when data from a sensor is not desired and/or necessary. For example, when a user wants to practice cervical procedures to limit or eliminate flow of amniotic fluid from the cervix and/or blood from blood vessels (e.g., a cerclage), execution of process 1000 may include execution of steps 1030 and 1035 and execution of step(s) 1020 and/or 1025 may be optional. Additionally, or alternatively, the steps of process 1000 need not always be performed in the order listed in FIG. 10. For example, in some embodiments, step 1015 may be performed before step(s) 1005 and/or 1010 and/or step 1030 may be performed before step(s) 1005, 1010, 1015, 1020, and/or 1025.

[00081] FIG. 12 is a flow diagram of an exemplary process 1200 for setting up and using a model cervix and/or system like the model cervixes and/or systems disclosed herein so that a user may, for example, practice performance of a cervical procedure upon a cervical model from which a portion of an amniotic sack is protruding from an os (e.g., os 120, 320, and/or 420) as shown in, for example, FIGs. 13A and 13B.

[00082] In some embodiments, execution of process 1200 may include execution of steps 1005, 1010, and/or 1015. In step 1205, an amniotic sac model may be prepared and/or added/inserted into a cervical model to, for example, approximate a situation in which the amniotic sac is protruding from a cervical os. The amniotic sac model may be generated (or pre-made) by, for example, filling a membrane (e.g., balloon or condom) with fluid (e.g., water, saline, etc.) and arranging the filled membrane within a model cervix. When the model cervix being used is model cervix 100, 201 , or 202, execution of step 1205 may include positioning an amniotic sac model (e.g., fluid-filled membrane or membrane to be later filled with fluid) within cavity 140 so that a portion of the membrane protrudes from cervical os 120. An example of this assembly is shown in FIG. 13A, which is a cross-section view of an assembly of model cervix 100, 201 , or 202, two sensor housings 710 positioned within a portion of cavity 140 within extension 110, two sensors 180, a portion of which is positioned with a respective sensor housing 180, and an amniotic sac model comprising a membrane 1310 in which fluid 1315 is contained. When properly assembled, a portion of membrane and fluid protrudes from os 120 (referred to herein as protruding portion 1320) as shown in FIGs. 13A and 13B, which approximates a portion of an amniotic sac that may protrude from a patient’s cervical os. In some embodiments, membrane 1310 may be pre-lubricated and, in other embodiments, a lubricant may be added to an exterior surface of membrane 1310, which may aid in positioning of membrane 1310 within model cervix 100, 201 , or 202 and/or cervical os 120. In some embodiments, model cervix 100, 201 , and/or 202 may include one or more channels in which lubricant may be pumped or injected externally into so that the lubricant may travel to an internal channel of the model cervix. When the assembly includes two sensors 180 as shown in FIGs. 13A and 13B, each sensor 180 and/or sensor housing 710 may be positioned so that it does not interfere with and/or obstruct access to membrane 1310. Optionally, sensor 180 may be embodied as a pressure transducer that is in communication with membrane 1310 so that it may measure pressure changes thereon as the user practices performance of an emergency cerclage (i.e., a cerclage procedure performed when the amniotic sac protrudes from the cervical os).

[00083]When the model cervix being used is model cervix 401 or 402, amniotic sac model (e.g., a membrane like membrane 1310 and fluid like fluid 1315) may be positioned within channel 455 and a portion thereof may protrude from os 420 in a manner similar to protruding portion 1320.

[00084]0ptionally, in step 1210, an assembly of the model cervix and amniotic sac model, an assembly of the model cervix, amniotic sac model, and sensor(s), or an assembly of the model cervix, amniotic sac model, sensor(s), and vaginal sheath may be affixed to mounting hardware and/or a stand as, for example, described herein and, optionally, in step 1215, an orientation and/or position of the assembly mounted in step 1210 may be adjusted in a manner similar to that described above with regard to, for example, step 1025.

[00085] In step 1220, when the assembly of the model cervix and amniotic sac model; the assembly of the model cervix, amniotic sac model, and sensor(s); or the assembly of the model cervix, amniotic sac model, sensor(s), and vaginal sheath are ready, the user may practice performing a procedure on the assembly (e.g., an emergency cerclage procedure) by, for example, pushing a portion (e.g., protruding portion 1320) of amniotic sac model protruding from a model cervical os (e.g., os 120 or 420) back through the cervical os using, for example, a tool (e.g., a plunger, rod, catheter, Foley catheter and/or Foley catheter with the tip resected). FIG. 13B provides an example of how step 1220 may be executed, wherein a user 1305 uses a plunger or rod 1350 to push protruding portion 1320 toward and through cervical os 120 or 420. On some occasions, the user may perform another cervical procedure (e.g., apply compression) upon the model cervix once the protruding portion of the amniotic sac membrane is repositioned below the cervical os in a manner similar to, for example, execution of step 1035. Optionally, in step 1225, data received from the sensor(s) may be reviewed and/or evaluated. At times, execution of step 1225 may be similar to execution of step 1040.

[00086] FIG. 14 is a block diagram of an exemplary system 1400 in/with which one or more methods or processes described herein may be executed. System 1400 includes a plurality of sensors 180A-180N, a computing device 1420, an optional network 1430, and an optional display device 1440, which may be resident within computing device 1420. Computing device 1420 may be any device configured to execute one or more data processing, analysis, and/or display steps described herein as, for example, described in process 1500 described herein (e.g., below with regard to FIG. 15). At times, computing device 1420 may include a user input device/interface (e.g., keyboard, touch screen, track pad, etc.) and a wired and/or wireless communication interface for communication with one or more components of system 1400. Display device 1440 may be any device configured to display information to a user including, but not limited to, a touch screen, monitor, dial, indicator light, etc. First, second, and/or nth sensors 180A, 180B, and/or 180N may each include sensing hardware and/or software 1405A, 1405B, and/or 1405N, respectively configured to sense and/or measure information as, for example, described herein. First, second, and/or nth sensors 180A, 180B, and/or 180N may also include a communication interface 1410A, 1410B, 1410N, respectively configured to, for example, communicate with one or more components of system 1400 via wired and/or wireless communication. First, second, and/or nth sensors 180A, 180B, and/or 180N may be embodied as, for example, a motion sensor, an accelerometer, a gyroscope, a pressure meter, a pressure transducer, a force, a moisture sensor, an electricity sensor (e.g., a voltmeter), and/or force flex sensor. Network 1430 may be any network that enables communication between components of system 1400 such as the Internet.

[00087] FIG. 15 provides a flowchart of an exemplary process 1500 for receiving and/or analyzing data received from one or more sensors (e.g., sensor 180) in accordance with, for example, one or more methods disclosed herein. Process 1500 may be executed by system 1400 and/or components thereof (e.g., computing device 1420 and/or sensor(s) 180).

[00088] In step 1505, sensor data from one or more sensors like sensors 180, 180A, 180B, and/or 180N may be received. Optionally, user input may also be received in step 1505. Exemplary user input received in step 1405 includes, but is not limited to, user identifying information, sensor type, system and/or device characteristics (e.g., type, size, durometer, etc.), cervical procedure the user is practicing using one or more of systems and/or devices disclosed herein, and the like. Exemplary sensor data received in step 1505 includes but is not limited to motion data, force data, pressure data, compression data, an orientation of, and/or moisture on or proximate to a cervical model (e.g., cervical model 100, 301 , 302, 401 , and/or 402), a portion of a cervical model (e.g., extension 110, 310, and/or 410) or a system and/or assembly including a cervical model (e.g., system and/or assembly 700, 700B, 700C, 801 , 802, 803, 900, and/or 1300). For example, moisture may be sensed by a sensor 270 configured as a moisture sensor. The moisture may come from, for example, water, saline, artificial blood, artificial amniotic fluid, and/or lubricant that may have originally been resident within channel 245 and/or channel lumen 455 and may be representative of the user’s puncture of channel 245 and/or failure to stop the flow of fluid from channel lumen 455. [00089] In step 1510, the received sensor and/or user input data may be analyzed to, for example, determine a magnitude or other characteristic thereof. Optionally, in step 1515, the sensor data and/or a result of the analysis of step 1510 may be compared with a threshold and/or benchmark value to, for example, determine whether or not the user has used the cervical model and/or performed the practice procedure correctly. Then, in step 1520, a result of the analysis (step 1510) and/or comparison (step 1515) may be communicated to a display device (e.g., display device 1440) for display to the user. Execution of step(s) 1510, 1515, and/or 1520 may provide valuable feedback to the user regarding their performance practicing the cervical procedure.

Claims

CLAIMS \Ne claim:

1 . A model cervix comprising: a base; and an extension projecting from the base, the extension being configured to approximate anatomical features of cervical tissue.

2. The model cervix of claim 1, wherein the base is configured to cooperate with mounting hardware to be mounted to a stand.

3. The model cervix of claim 1 or 2, wherein the extension comprises a reinforcing component configured to maintain structural integrity of the extension when the extension is repeatedly sutured.

4. The model cervix of any of claims 1-3 wherein the base and extension are manufactured using silicone.

5. The model cervix of any of claims 1-4, wherein the base and extension are manufactured in one piece.

6. The model cervix of any of claims 1-5, further comprising an opening positioned on an end of the extension not in communication with the base, the opening being configured to approximate an external cervical os.

7. The model cervix of any of claims 1-6, further comprising: a chamber configured to hold fluid, a hydrogel, silicone, soft silicone, and/or a polymer.

8. The model cervix of claim 7, wherein the internal chamber is filled with the fluid, hydrogel, silicone, soft silicone, and/or polymer and a portion of the internal chamber is defined by an expandable wall segment configured to expand to accommodate displacement of the fluid hydrogel, silicone, soft silicone, and/or polymer within the internal chamber.

9. The model cervix of claim 7 or 8, wherein displacement of the fluid is caused by compression of the extension.

10. The model cervix of claim 7, 8, or 9, wherein displacement of the fluid is caused by tilting the extension.

11 . The model cervix of any of claims 7-10, wherein displacement of the fluid is caused by suturing the extension to close the opening.

12. The model cervix of any of claims 7-11 , wherein displacement of the fluid is caused by suturing the extension to change an angle of orientation of the extension.

13. The model cervix of any of claims 7-12, wherein the chamber resides in an interior portion of the base and the extension.

14. The model cervix of any of claims 7-13, further comprising a membrane separating a first portion of the chamber from a second portion of the chamber.

15. The model cervix of claim 14, wherein the first portion resides in the base and the second portion resides in the extension.

16. The model cervix of claim 14 or 15, wherein the membrane is configured to expand or deform responsively to fluid displacement within the first portion of the chamber or the second portion of the chamber.

17. The model cervix of any of claims 1-16, further comprising: a channel resident within the body and configured to approximate a blood vessel

18. The model cervix of any of the above claims further comprising: an opening positioned on an end of the extension not in communication with the base, the opening being configured to approximate an external cervical os; and a central channel that is open to the opening and extends from the opening through the extension and a portion of the base.

19. The model cervix of claim 18, wherein the channel is defined by a channel wall of approximately uniform thickness.

20. The model cervix of claim 18, wherein the channel is defined by a channel wall of approximately varying thicknesses.

21 .The model cervix of claim 20, wherein a thickness of a first portion of the channel wall extending through the extension is less than a thickness of a second portion of the channel wall extending through a portion of the base.

22. The model cervix of claim 20, wherein a thickness of a first portion of the channel wall is configured to enable compression of the extension.

23. The model cervix of any of claims 18-22, wherein fluid is placed within the central channel so that a user may practice performance of a procedure on the model cervix while limiting emission of the fluid from the central channel.

24. A system comprising: the model cervix of any of any of claims 1-23; and a vaginal sheath comprising: a sidewall defining a cavity; the cavity, the cavity being configured to accept insertion of the model cervix therein; and an opening configured to allow access to the extension.

25. The system of claim 24, wherein the cavity is sized and configured to approximate anatomical features of a vagina.

26. The system of claim 24 or 25, wherein a portion of the sidewall is configured to fit over the base, thereby holding the vaginal sheath in place relative to the model cervix.

27. The system of any of claims 24-26, further comprising: mounting hardware configured to mount an assembly of the model cervix and the vaginal sheath.

28. A system comprising: the model cervix of any of claims 1 -23; and a sensor configured to sense a condition of the model cervix.

29. The system of claim 28, wherein the sensor is a force sensor configured to measure compression of the extension or base.

30. The system of claim 28 or 29, wherein the sensor is configured to measure an orientation of the model cervix or the extension.

31 .The system of any of claims 28-30, wherein the sensor is at least one of a motion sensor, an accelerometer, a gyroscope, a pressure meter, a pressure transducer, and/or a force and/or force flex sensor.

32. The system of any of claims 28-31 , wherein the sensor is positioned within a cavity of the model cervix.