Cervical control device, cervical control system and use method thereof

Abstract

A system, device, and method of controlling, supporting, and / or elongating the cervix uteri are provided to treat gestation complications and / or delay the onset of childbirth such that the gestation period of a fetus can be extended to prevent preterm birth and childbirth of the fetus. A cervical control system may include a body configured to be placed in the vagina. The body has an internal channel configured for receiving a cervix therein and an inflatable and / or inflatable inner cuff extending from a portion of the internal channel. The inner cuff may inflate inwardly toward the cervix, or downwardly away from the cervix, or both inwardly and downwardly, such that the inner cuff may engage or clamp the cervix to secure the cervix control system in place while pressing the cervix to close, elongate, and / or adjust the cervix orientation angle.

Description

Related applications

[0001] This international PCT application claims priority to U.S. Provisional Patent Application No. 63 / 487,802, filed March 1, 2023, entitled “DEVICE FOR REDUCTION OR PREVENTION OF PRETERM LABOR”, and U.S. Provisional Patent Application No. 63 / 617,030, filed January 2, 2024, entitled “SYSTEMS AND DEVICES FOR CERVICAL SUPPORT AND FLUID DELIVERY AND METHODS FOR USING SAME”, the entire contents of which are incorporated herein by reference. Technical Field

[0002] This disclosure relates to reproduction, pregnancy, and prenatal health, and, for example, to devices, methods, and systems for controlling the cervix to, for example, prevent preterm birth, and / or reduce pregnancy complications, and / or treat pelvic organ prolapse. Background Technology

[0003] The most common cause of infant mortality is complications arising from preterm birth. Several factors contribute to preterm birth, the most common being cervical insufficiency, medically known as a "short cervix." When a short cervix occurs in a singleton pregnancy (i.e., a single fetus), a common intervention involves placing a suture in the cervix to attempt to delay labor; this intervention is called cervical cerclage. Interventions for cervical insufficiency in multiple pregnancies (i.e., multiple fetuses) are typically limited and may only provide limited relief.

[0004] Another intervention for short cervixes is the application of vaginal progesterone to the cervix to maintain its length and structure. However, vaginal progesterone cannot remain on the cervix for an extended period, as vaginal secretions gradually wash it away over time. Furthermore, the application of vaginal progesterone to the cervix is ​​an invasive procedure requiring a clinician to insert the medication through the vagina. Summary of the Invention

[0005] This document discloses cervical control devices, systems, and methods of use to, for example, control and / or regulate anatomical and / or functional aspects of the cervix in pregnant mammals (in most cases, pregnant human women, referred to herein as "patients" in some contexts), including but not limited to cervical length, degree of dilation, and orientation. For example, the systems, devices, and / or methods disclosed herein can be used to compress the cervix (which may be partially dilated and closed, or may not be partially dilated and closed), which may delay the onset of labor and / or allow for the regeneration of the cervical mucus plug. Additionally or alternatively, the systems, devices, and methods disclosed herein can be used in patients with risk factors and / or indications associated with premature rupture of membranes (PROM) or preterm premature rupture of membranes (PPROM). In these cases, compression of the cervix using the systems, devices, and methods disclosed herein can serve to stabilize cervical closure, thereby slowing or stopping leakage of amniotic fluid from the membranes and / or replenishing amniotic fluid lost due to rupture of the amniotic sac.

[0006] Additionally or alternatively, the systems, devices, and methods disclosed herein can be used in patients with risk factors and / or indications related to preterm birth and / or a short cervix. Additionally or alternatively, the systems, devices, and / or methods disclosed herein can also be used to support a patient's uterus and / or pelvic organs to avoid and / or mitigate the effects of pelvic organ prolapse. The cervical control devices and / or systems disclosed herein function, but are not limited to, preventing preterm birth and / or preterm delivery, thereby prolonging the gestation period of the patient's fetus.

[0007] The systems, devices, and / or methods disclosed herein can be used in response to one or more factors and / or indications, including but not limited to the patient's medical history, condition, age, and / or risk factors, which can be determined by analyzing the patient's blood test results and / or imaging of the patient's uterus and / or cervix (e.g., ultrasound). In some cases, even when no indications or symptoms are present that may trigger preterm labor, the systems, devices, and / or methods disclosed herein can be used in moderate-risk and / or high-risk situations to prevent the onset of labor and / or preterm labor, thereby preventing preterm labor.

[0008] The cervical control device and / or system disclosed herein may include a body configured for insertion into a patient's vagina, such that an internal channel of the body can receive insertion of the patient's cervix. The body may be flexible and / or foldable to facilitate compression, deformation, and / or folding prior to vaginal insertion, and the size and / or shape of the body may be configured to occupy space within the vagina near the anterior fornix and / or posterior fornix. The internal channel may be configured to receive the patient's cervix therein and may be defined by a cylindrical aperture or orifice located within the body. The internal channel may extend from one end of the body to the other. In some embodiments, a portion of the internal channel and / or the outer surface of the inner sheath may include and / or be coated with, for example, a drug, antibacterial agent, friction enhancer, and / or adhesive.

[0009] The body may also include an inflatable medium conduit disposed within its sidewall. A first end of the inflatable medium conduit may open into and be configured to communicate fluidly with the lumen defined by the flexible membrane of the inner cuff of the cervical control device and / or system. A second end of the inflatable medium conduit may include an inlet configured to receive fluid and / or an inflatable medium (e.g., water, saline, hydrogel, fluid, gas, etc.) to communicate with the lumen of the inner cuff via the first end of the inflatable medium conduit. For purposes of discussion, the portion of the body adjacent to the inner cuff may be referred to herein as the proximal or upper portion or upper side portion of the cervical control device and / or system and / or body, while the portion of the body located opposite the inner cuff may be referred to herein as the distal or lower portion or lower side portion of the cervical control device and / or system and / or body.

[0010] In some cases, the body may have a circular, oval, or irregular horizontal cross-sectional shape. In some embodiments, the radial center of the inner sheath and / or internal passage may be offset from the radial center of the body. Alternatively, the radial center of the inner sheath and / or internal passage may be aligned with the radial center of the body. In some embodiments, the body may include a release notch configured to allow at least one of bending and expansion of the body. Additionally or alternatively, the cervical control device and / or system may also include an annular ring located on the proximal edge of the body and proximal to the inner sheath, the annular ring including a tapered edge configured to guide the cervix into the internal passage.

[0011] The inner sheath may include a flexible membrane defining an inner lumen therein. The flexible membrane may be configured to expand when an inflation medium is added to the lumen via a first end of an inflation medium conduit and / or when the lumen is otherwise pressurized. In some embodiments, the expansion direction of the flexible membrane is radially inward toward the inner channel, such that the outer surface of the inner sheath contacts and compresses the cervix located within the inner channel, and the pressure exerted on the cervix by the expanded flexible membrane increases with the increase in the volume of the inflation medium added to the lumen.

[0012] Additionally or alternatively, the flexible membrane may expand downward or distally, thereby drawing the cervix further into the internal passage and / or elongating the cervix within the internal passage. Additionally or alternatively, the expansion of the flexible membrane can be used to adjust the orientation angle of the cervix, the degree of cervical dilation, and the length of the cervix. In some cases, the elongating force exerted on the cervix by the expanded flexible membrane may also increase with the increase in the volume of the swelling medium added to the lumen. In some embodiments, the expansion of the flexible membrane may cause the cervix to twist or bend.

[0013] In some embodiments, the thickness of the flexible membrane may be uniform or consistent across the entire flexible membrane, and in other embodiments, the thickness of the flexible membrane may be variable across the entire flexible membrane. For example, when the inner bladder is in a neutral or uninflated state, the thickness of the apical portion of the flexible membrane may be greater than the thickness of the upper or proximal portion and / or the lower or distal portion of the flexible membrane. In this example, the thickness of the apical portion of the flexible membrane may decrease as the flexible membrane expands to facilitate the expansion of the inner bladder. Additionally or alternatively, when the inner bladder is in a neutral state, the length of the upper or proximal portion of the flexible membrane may be greater than the length of the lower or distal portion of the flexible membrane, and in this example, due to the longer length of the proximal portion of the flexible membrane, the flexible membrane may expand in the distal and / or downward direction. Additionally or alternatively, the flexible membrane may include folds or other features configured to assist the expansion of the flexible membrane when the lumen can expand.

[0014] In many cases, the flexible membrane of the inner sheath can also be configured to deflate or contract when the inflation medium is withdrawn from the lumen. The degree of expansion or contraction of the flexible membrane of the inner sheath can be controlled by the volume of the inflation medium present in the lumen and / or the pressure level in the lumen. The degree of expansion or contraction of the flexible membrane of the inner sheath can be responsive to indications such as patient comfort, clinical needs, cervical orientation, uterine orientation, degree of cervical dilation, cervical length, degree of cervical softening, and / or the condition of the amniotic sac.

[0015] In some embodiments, the inner sheath may also include a plurality of (e.g., two, three, four, or six) flexible membranes, and each of the plurality of flexible membranes may define a separate lumen therein, the separate lumen being in fluid communication with an inflation medium conduit and configured to expand when an inflation medium is added to each respective lumen and to contract when an inflation medium is withdrawn from each respective lumen.

[0016] In some embodiments, the flexible membrane may further include one or more expandable portions and one or more recessed portions, the expandable portions being configured to expand upon the addition of an inflation medium to the lumen, and the recessed portions being configured to expand to a minimum or not at all when the expandable portions expand. In some cases, a second recessed portion may be positioned at approximately 180 degrees relative to a first recessed portion. The size, structure, and / or location of one or more recessed portions may be configured within the flexible membrane to correspond to the predicted location of cervical vessels (e.g., arteries), such that when the flexible membrane expands, the recessed portions do not expand like the expandable portions, thereby avoiding compression of cervical vessels and allowing blood to flow across the entire cervix, which is particularly important for long-term (e.g., hours or days) use of the devices and / or systems disclosed herein.

[0017] In some cases, one or more wedges may be provided and extended on the outer surface of the flexible membrane and / or the expandable portion of the flexible membrane. In some cases, the wedges may not be located on the outer surface of the recessed portion. The wedges may be configured to press into and secure the cervix, and / or increase the coefficient of friction between the cervix and the flexible membrane, to, for example, effectively retain the cervix within the internal passage and / or prevent accidental movement (e.g., slippage from the cervix) of the cervical control device and / or system.

[0018] One or more wedges may have semicircular, rectangular, parallelogram, triangular, oval, trapezoidal, hook-shaped, curved, and irregular radial, cross-sectional, and / or raised profiles. The wedges may be arranged in any manner (including, but not limited to, at different points on one or more concentric rows, columns, and staggered arrays of wedges extending from the outer surface of the flexible membrane.

[0019] In some embodiments, the cervical control apparatus and / or system disclosed herein may include a valve and / or a valve housing, and / or be permanently or removably coupled to the valve and / or valve housing. The valve may be configured to be in fluid communication with a second end of an inflatable medium conduit and indirectly in fluid communication with an inner lumen. For example, the valve and / or valve housing may be configured to receive an inflatable medium source inserted therein. The inflatable medium can then be transferred from the inflatable medium source to the inflatable medium conduit via a passage through the valve. When the inflatable medium source is removed from the valve, the valve may close, thereby retaining the inflatable medium in the inflatable medium conduit and the inner lumen and maintaining the flexible membrane in an inflated state. When it is necessary to contract the inner sac / flexible membrane, the valve may be opened, allowing some or all of the inflatable medium to escape from the inflatable medium conduit and / or the inner lumen. Exemplary sources of the inflatable medium include, but are not limited to, syringes, pumps, and tubing.

[0020] Exemplary valves include, but are not limited to, check valves, duckbill valves, silicone valves, check valves, Halkey Roberts valves, Luer-type check valves, check valves with polycarbonate bodies, and other check valves. In some embodiments, the valve and / or valve body may be permanently or detachably coupled to a second end of an expansion medium conduit of the body. Additionally or alternatively, the second end of the expansion medium conduit may be permanently or detachably coupled to a first end of a tube or conduit, which may be permanently or detachably coupled to the valve and / or valve body.

[0021] In some embodiments, the valve housing may include a pressure sensor and / or a cap configured to cover the valve when not in use.

[0022] In some embodiments, the inflatable medium catheter may be configured (e.g., having sufficient length) to extend beyond the main body, allowing access from outside the patient's vaginal opening. Optionally, a second end of the inflatable medium catheter may be coupled to a tube or catheter configured (e.g., having sufficient length) to extend externally, allowing access from outside the patient's vaginal opening without interfering with or moving the cervical control device and / or system when in situ. In some cases, the valve and / or valve housing may be configured to be removed from the second end of the inflatable medium catheter and / or tube coupled thereto after use, allowing the second end of the inflatable medium catheter and / or tube coupled thereto to be placed inside the patient's vagina and / or strapped to the patient's leg. This reduces the weight of the system, including the cervical control device and / or system and the valve / valve housing, thereby reducing the likelihood of the system being pulled away from its preferred position by gravity and / or increasing patient comfort when the cervical control device and / or system is in situ but the valve and / or valve housing is not in use.

[0023] In many embodiments, the cervical control device and / or system disclosed herein may include a positioning balloon positioned on the outer surface of a body, which may inflate when an inflation medium is positioned within the positioning balloon. In some embodiments, the positioning balloon may include a flexible membrane defining an inner lumen configured to receive the inflation medium. When the inner lumen is filled with the inflation medium, the flexible membrane of the positioning balloon may extend and inflate outward away from the outer surface of the body, thereby causing peripheral expansion of a portion of the cervical control device and / or system. In some cases, the cervical control device and / or system disclosed herein may include a second or positioning balloon inflation medium conduit disposed within a sidewall of the body. A first end of the positioning balloon inflation medium conduit may open into and be configured to communicate fluidly with the positioning balloon inner lumen defined by the flexible membrane of the positioning balloon. A second end of the positioning balloon inflation medium conduit may include an inlet or valve configured to receive injection of the inflation medium to communicate with the positioning balloon inner lumen through the first end of the positioning balloon inflation medium conduit. In some cases, the positioning balloon inflation medium catheter can be connected to the inner cuff inflation medium catheter, so that the inflation medium entering the inlet can be connected to the inner cuff and / or positioning balloon.

[0024] Similar to the inflation medium catheter used for the inner balloon, the second end of the positioning balloon inflation medium catheter can be permanently or detachably coupled to a valve and / or valve body. The valve and / or valve body can be similar to the valve and / or valve body permanently or detachably coupled to the second end of the inner balloon inflation medium catheter.

[0025] The positioning balloon may surround all or a portion (e.g., 20-75%) of the distal portion of the outer surface of the body. Alternatively or additionally, the positioning balloon may be positioned at the distal end of the body. In some embodiments, the positioning balloon may be configured to adjust the orientation of the cervical control device and / or system when positioned within the vagina and inflated. Alternatively or additionally, the positioning balloon may be configured to adjust the orientation angle of the cervix upon inflating.

[0026] In some embodiments, the cervical control device and / or system disclosed herein can be integrally manufactured and / or integrally molded. In these embodiments, the flexible membrane can be molded to have a first extension and a second extension, the first extension surrounding a proximal edge of the flexible membrane and the second extension surrounding a distal edge of the flexible membrane, and the body can be molded to have a first recess and a second recess, the first recess being sized, positioned, and configured to receive the first extension and the second recess being sized, positioned, and configured to receive the second extension, wherein an inner sheath can be formed when the first extension can be located within the first recess and the second extension can be located within the second recess.

[0027] Additionally or alternatively, in some embodiments, the cervical control devices and / or systems disclosed herein may also include a liquid delivery device, catheter, or channel, comprising at least one port configured to allow liquid to be delivered from the liquid delivery device and / or leak into the cervix. The liquid delivery device may be disposed near the outer surface of the internal channel and / or the inner sheath and / or its flexible membrane, and may be in liquid communication with the liquid catheter. Liquid leaking from and / or delivered by the liquid delivery device includes, but is not limited to, drugs, antibacterial agents, and hormones. In some cases, the liquid catheter may be in communication with the lumen of the inflatable medium catheter and / or the inner sheath. In these embodiments, the inflatable medium may be a fluid intended to be delivered to the cervix via the liquid delivery device, such that the lumen of the inner sheath and / or positioning balloon is inflated using this fluid.

[0028] This document also discloses kits that include one or more cervical control devices and / or systems disclosed herein, and, for example, sources of inflation media, speculum, measuring devices (configured to, for example, measure the length and / or structural integrity of the cervix), forceps, cervical stabilizing devices, hooks, and / or sensors. In some embodiments, the kit may also include a valve housing configured to be in fluid communication with an inflation media conduit (e.g., an inner sheath and / or a positioning balloon inflation media conduit) of the cervical control device and / or system included in the kit. Exemplary sources of inflation media include, but are not limited to, syringes, pumps, and inflation media containers.

[0029] In some embodiments, the cervical control devices and / or systems disclosed herein can provide selective, adjustable, or customizable support and / or control of a patient's cervix and can help delay delivery in singleton and multiple pregnancies, such as for individuals with cervical insufficiency. In some embodiments, the cervical control devices and / or systems disclosed herein can be used to support or reduce the effects of pelvic organ prolapse. The cervical control devices and / or systems disclosed herein may include one or more inflatable portions, balloons, cuffs, or pouches (collectively referred to herein as "cuffs") that can selectively inflate and deflate individually and / or collectively to provide the desired degree of cervical control, cervical compression, and / or cervical position correction. The cervical control device and / or system disclosed herein may include a proximal or inner cuff configured and positioned to engage, control, and / or support the cervix, uterus, and / or fetus, and an outer cuff and / or positioning balloon configured and / or positioned to engage the patient's vaginal wall to support the disclosed cervical control device and / or system near the cervix upon inflating. The inner cuff may be used to apply contractile pressure to the outside of the cervix at the apex of the fornix to attempt to close and / or secure the cervix in a closed state.

[0030] The internal and / or positioning balloon may include one or more individually controllable (e.g., inflatable / contractable) pouches comprising a flexible membrane and an inner lumen. One or more inner pouches may be configured to cooperate with each other to inflate and compress the cervix. In some cases, the inner pouch may be configured to allow blood / fluid to perfuse into the cervix (e.g., by inflating the inflatable portion of the inner pouch) while simultaneously providing sufficient pressure to the cervix.

[0031] The anatomical structure of the cervix may vary from patient to patient in terms of nominal external dimensions, and a cervix with cervical insufficiency may (and is very likely) continue to contract during pregnancy. Therefore, the adjustable functionality of the cervical control devices and / or systems disclosed herein allows care providers (e.g., medical providers such as physicians, midwives, or nurses) to customize cervical support and / or control for a particular patient's cervix by instructing and / or adjusting the inflation / contraction of the inner sac.

[0032] In some cases, when positioned within the patient's vagina, the positioning balloon can be used to adjust the position of one or more cervical control devices and / or systems disclosed herein, and these adjustments can adjust the orientation of the respective cervical control device and / or system relative to the cervix, thereby allowing for reorientation and / or flexion of the cervix.

[0033] Optionally, the cervical control device and / or system disclosed herein can be inverted such that the distal opening is positioned near the vaginal fornix (i.e., facing the cervix), while the inner sac is positioned near the external os of the cervix. In this orientation, the cervical control device and / or system disclosed herein can provide support for pelvic organs (e.g., the bladder and uterus) in the event of prolapse (e.g., uterine prolapse or cervical prolapse) without direct contact with the lower part of the cervix.

[0034] In cases of premature rupture of membranes (PROM) and preterm premature rupture of membranes (PPROM), the use of the cervical control devices and / or systems disclosed herein can also be beneficial in reducing or limiting the risk of infection and / or prolonging fetal development, as the cervical control devices and / or systems disclosed herein are used to fix the cervix closed, thereby preventing the migration of bacteria and foreign bodies (which can lead to infection) into the cervix and / or uterus. Furthermore, the cervical compression provided by the cervical control devices and / or systems disclosed herein allows for the regeneration of the cervical mucus plug, which also helps prevent bacterial migration into the cervix and uterus. This is particularly advantageous because there has traditionally been no effective treatment for patients who have experienced PROM or preterm premature rupture of membranes. Cervical rings are contraindicated in this situation due to the risk of introducing infection or potentially causing cervical lacerations during delivery.

[0035] Furthermore, the cervical control devices and / or systems disclosed herein can be configured to contact / engage the exterior of the cervix without contacting (or minimally contacting) the cervical os. Therefore, the cervical control devices and / or systems disclosed herein can provide support and control of the cervix without introducing infection into the uterus. Mechanical closure and tilting of the cervix can increase amniotic fluid retention, thereby improving fetal outcomes. Moreover, because the cervical control devices and / or systems disclosed herein do not cover the cervical os during use, unlike cervical caps, they do not create an environment conducive to the growth of anaerobic bacteria. Therefore, using the cervical control devices and / or systems disclosed herein may be safer than using cervical caps that cover the cervical os and thus create a bacterial growth environment.

[0036] According to some embodiments, the cervical control device and / or system disclosed herein may include a body defining an internal passage for receiving the cervix. The body may include upper and lower portions defining a proximal opening and a distal opening of the internal passage, respectively, and an outer surface for engaging the vaginal wall. An inner sheath may be coupled to and / or extend from the body at or near the proximal opening. The inner sheath may be configured to receive and surround at least a portion of the cervix when in an uninflated state. Once in place, the inner sheath may be configured to inflate from a neutral state to an inflated state, such that the inner sheath can contact and / or engage at least a portion of the cervix. Once the cervix is ​​secured by the inner sheath, a positioning balloon may be inflated, thereby expanding from the axial center of the distal opening toward the vaginal wall and entering the vaginal wall.

[0037] The cervical control device and / or system disclosed herein may include one or more of the following features. In one embodiment, the positioning balloon may include a small, circumferentially arranged arcuate segment of less than 180 degrees surrounding the outer or lower (distal) surface of the body. In another embodiment, the positioning balloon may include a main arcuate segment of greater than 180 degrees surrounding the outer or lower (distal) surface of the body. In some embodiments, in the inflated state, the radius of the cervical control device and / or system disclosed herein, measured from the axial center of the distal opening to the outer periphery of the positioning balloon, may be greater than the radius of the cervical control device and / or system, measured from the axial center of the distal opening to the circumferential periphery of a portion of the body without the positioning balloon. In some embodiments, the positioning balloon may include a variable or non-uniform wall thickness (and / or elastic or flexible), the variable or non-uniform wall thickness being configured to control the expansion of the positioning balloon away from the axial center of the distal opening to expand toward and enter the vaginal wall. In some embodiments, the positioning balloon may include a first wall thickness located proximally to the device, a second wall thickness located distally to the device, and a third wall thickness located on the outer periphery of the positioning balloon (the third wall thickness extends between the first and second walls). In some embodiments, the first and second wall thicknesses may be substantially the same, and the third wall thickness may be greater than the first and second wall thicknesses. In some embodiments, the length of the first wall may be different from the length of the second wall. In some embodiments, the body may include a hemispherical body or other curved shape, and the area defined by the proximal opening is smaller than the area defined by the distal opening. In one embodiment, the cervical control device disclosed herein may further include one or more wedges disposed along the inner periphery of the inner sac for clamping the exterior of the cervix and holding the cervical control device in place relative to the cervix.

[0038] In some embodiments, the inner sac is configured such that when the inner sac expands around the cervix, it expands substantially radially inward toward the axial center of the proximal opening and / or downward toward the transverse plane of the proximal opening and away from the uterus.

[0039] Additionally or alternatively, the inner sheath and / or its flexible membrane may include a non-uniform wall thickness. For example, the flexible membrane of the inner sheath may include a first wall thickness located proximal to the device, a second wall thickness located distal to the device, and a third wall thickness located on the inner surface of the inner sheath (the third wall thickness extends between the first and second walls). In some embodiments, the first and second wall thicknesses may be substantially the same, and the third wall thickness may be greater than the first and / or second wall thicknesses.

[0040] Alternatively or additionally, the inner cuff may include an inner wall configured at an angle relative to the axial center of the proximal opening. Alternatively or additionally, the inner cuff may include an inner wall opposite a wall on the inner surface of the inner cuff, wherein the inner wall may be configured parallel to the axial center of the proximal opening.

[0041] Additionally or alternatively, the inner sheath may include an inflatable portion adjacent to the recessed portion, wherein the inflatable portion may selectively extend further into the internal channel than the recessed portion. In some embodiments, the inner sheath may include a non-uniform wall thickness, wherein the recessed portion has a greater wall thickness than the inflatable portion, wherein the thicker wall thickness of the recessed portion limits the expansion of the recessed portion relative to the inflatable portion upon expansion. In some embodiments, the inner sheath may include at least two recessed portions and at least two inflatable portions, the at least two inflatable portions being alternately spaced from the recessed portions.

[0042] Additionally or alternatively, the cervical control device disclosed herein may also include one or more inflatable medium catheters, the inflatable medium catheters being sized, shaped, and configured to be in fluid communication with the inner balloon and / or positioning balloon, and facilitating the injection and withdrawal of inflatable medium from the inner balloon and / or positioning balloon. In some cases, the inflatable medium catheter may be configured to receive injection and / or withdrawal of inflatable medium through inlets, ports, and / or valves. In some embodiments, a valve is operable to removably receive a portion of an inflatable device operable to inflate the first and / or positioning balloon without requiring removal of the device from the patient's vagina.

[0043] In some embodiments, the cervical control device may further include a pump and a fluid reservoir disposed within the body. The pump may be in fluid communication with the fluid reservoir, and the fluid reservoir may be in fluid communication with the inner sheath and / or positioning balloon. The pump may be configured to deliver or move an inflation medium between the fluid reservoir and the inner sheath and / or positioning balloon to achieve inflation and contraction of the respective inner sheath or positioning balloon. In some embodiments, the cervical control device may further include a wireless control device for remotely controlling the pump.

[0044] In another embodiment, one or more cervical control devices disclosed herein may include: a hemispherical body or other curved body defining an internal channel for receiving the cervix, the body including an upper portion and a lower portion defining a proximal opening and a distal opening, respectively, and an outer surface for engaging the vaginal wall to support a device proximal to the cervix, the body (e.g., the hemispherical body) including an inner sheath coupled to the body at the proximal opening and configured to surround at least a portion of the cervix, and a positioning balloon disposed at one or both of an outer portion of the body and a lower portion of the body proximal to the distal opening, the positioning balloon being configured to expand axially away from the distal opening to expand toward the vaginal wall and enter. The system comprises: a vaginal wall; a positioning balloon that can inflate from a neutral state to an inflated state, the periphery of which is enlarged in the inflated state compared to its periphery in the neutral state; an inflatable medium conduit including a first end configured to be in fluid communication with the first and / or positioning balloon and a second end opposite to the first end; a valve including a first end configured to be in fluid communication with the second end of the inflatable medium conduit and a second end opposite to the first end, the second end being configured to receive part of an inflatable device that can inflate the first and / or positioning balloon without removing the cervical control system from the patient's vagina; and a valve housing including a first end and a second end configured to receive the inflatable medium conduit, the second end including an opening configured to surround the first end of the valve. In some embodiments, multiple valves are used.

[0045] In some embodiments, the cervical control device disclosed herein may be permanently or detachably coupled to a valve and / or valve housing, the valve and / or valve housing including sensors and / or pressure gauges configured to provide tactile and / or visual indications of pressure within the inner and / or positioning balloons. In some embodiments, the pressure gauge may include a pressure balloon configured to gradually inflate to indicate the amount of pressure increase within the device. In some embodiments, the pressure balloon may have varying wall thickness and / or be color-coded, the varying wall thickness and / or color coding being configured to indicate different pressure levels within the first and / or positioning balloons.

[0046] Although the device described herein is referred to as a "cervical control device," in some embodiments, such a device can also be used to support tissues other than the cervix, such as to support the uterus or bladder in cases of possible pelvic organ prolapse. In the case of pelvic organ prolapse (POP), the cervical control device disclosed herein can be used to support tissues or organs that have prolapsed and / or are displaced or are causing discomfort to the patient. For example, when the cervical control device disclosed herein is used to treat bladder prolapse, the cervical control device can be positioned within the vagina to keep the bladder in an elevated position within the pelvis. For uterine prolapse, the cervical control device disclosed herein can be used to hold the uterus in an elevated position within the pelvis and prevent the cervical control device from descending into the vagina or dislodging from the vaginal opening.

[0047] In several embodiments described herein, the cervical control device disclosed herein can be configured to expand from a neutral state to a swollen state. This includes, for example, expanding from a swollen state or a less swollen state to a more swollen state. In some embodiments, expansion may occur gradually or simultaneously over time, and the degree of expansion of the internal and / or positioning balloon may be responsive to, for example, the patient's physiological condition and / or patient comfort.

[0048] In some embodiments, the device described herein is coated with, embedded with and / or otherwise includes one or more active or inactive agents, such as drugs, hormones, anti-irritants, lubricants, progesterone, tocolytics, antimicrobial APIs (active pharmaceutical ingredients) or silver nitrate (inactive pharmaceutical ingredients may be used).

[0049] In several embodiments, the devices and methods described herein work in conjunction with medications that delay preterm labor (e.g., medications that can slow or stop uterine contractions). In some embodiments, if one of the cervical control devices disclosed herein is used to control the cervix according to one or more embodiments described herein, such medications may require only a shorter course of treatment, a lower dose, or may not be needed at all, thereby reducing undesirable side effects.

[0050] In another embodiment, a method for supporting and reinforcing tissue (e.g., the cervix) is provided, wherein the method may include positioning a cervical control device around a patient's tissue (e.g., the cervix). The cervical control device may include a body defining an internal channel for receiving tissue (e.g., the cervix), upper and lower portions defining a proximal and a distal opening of the internal channel, respectively, and an outer surface (e.g., for engaging a vaginal wall or other structure). An inner sheath may be coupled to and / or extend from the body at or near the proximal opening. The inner sheath may be configured to surround at least a portion of the tissue (e.g., the cervix). The cervical control device may also include a positioning balloon disposed on an outer portion of the body and / or a lower portion of the body near the distal opening, wherein the positioning balloon is disposed surrounding a circumferential portion of the body. Once in place, the inner sheath may be inflated to expand it from a neutral state to a swollen state, such that the inner sheath contacts and / or engages at least a portion of the tissue (e.g., the cervix). The positioning balloon is also inflated, and when the positioning balloon is inflated, it can expand away from the axial center of the distal opening, thereby expanding toward the desired area (e.g. toward and into the vaginal wall). The positioning balloon expands from a neutral state to an inflated state, and the outer perimeter of the positioning balloon in the inflated state is larger than that of the positioning balloon in the neutral state.

[0051] In some embodiments, the cervical control device may further include an inflation medium conduit in fluid communication with the first and / or positioning balloon, and a valve in fluid communication with the inflation medium conduit. In some embodiments, the method may further include connecting an inflation device to the valve to inflate the inner sheath and / or positioning balloon in situ without removing the cervical control device from the patient's vagina and / or detaching it from the cervix. In some embodiments, the positioning balloon may include a small arcuate segment surrounding the body with a circumferential orientation of less than 180 degrees. In some embodiments, the positioning balloon may include a main arcuate segment surrounding the body with a circumferential orientation of greater than 180 degrees. In some embodiments, the positioning balloon may include a non-uniform wall thickness configured to control the inflation of the positioning balloon away from its distal opening at an axial center to inflate toward and into the vaginal wall in situ.

[0052] According to another embodiment, a method for treating prolapse may include positioning a cervical control device, similar to a cervical control device disclosed herein, around the cervix of a patient. The cervical control device may include a body defining an internal passage for receiving the cervix, upper and lower portions defining a proximal and a distal opening of the internal passage, respectively, and an outer surface for contacting, engaging, and / or wedging into the vaginal wall. The cervical control device may also include a positioning balloon disposed on the exterior of the body and / or near the lower (or distal) edge of the distal opening. When the positioning balloon is positioned to surround a portion of the outer periphery of the body, inflation of the positioning balloon may cause the balloon to expand in a desired direction (e.g., along an axial center away from the distal opening and toward and into the vaginal wall).

[0053] According to another embodiment, the cervical control device may include: a body defining an internal passage for receiving the cervix, the body including upper and lower portions defining a proximal opening and a distal opening respectively leading to the internal passage, an outer surface for engaging the vaginal wall, and an inner sheath coupled to the body and / or extending from the body at or near the proximal opening. The inner sheath may be configured to surround at least a portion of the cervix and inflate from a neutral state to a swollen state, in which the inner sheath is configured to engage at least a portion of the cervix. In some cases, the inner sheath may include a non-uniform wall thickness configured to control the expansion of the inner sheath in a desired direction (e.g., radially inward expansion and / or downward expansion away from the transverse plane of the proximal opening and away from the uterus) when the inner sheath expands to surround and engage the cervix. The cervical control device may also include a positioning balloon disposed on the exterior of the body and / or on the lower (distal) edge of the body near the distal opening. A positioning balloon may be disposed circumferentially around a portion of the body and configured to inflate toward and into the vaginal wall from an axial center away from the distal opening. As the positioning balloon inflates from a neutral to a full state, its outer circumference increases compared to its outer circumference in the neutral state. The positioning balloon may include a small arcuate segment shape and / or a non-uniform wall thickness disposed circumferentially around a portion of the body less than 180 degrees. This non-uniform wall thickness is configured to control the inflation of the positioning balloon toward and into the vaginal wall from an axial center away from the distal opening, rather than, for example, toward the distal or proximal opening.

[0054] According to some embodiments, a cervical control device for supporting and / or controlling a patient's cervix is ​​provided, the cervical control device comprising a body sized and shaped for placement within a patient's vagina. The body defines an internal channel having a proximal opening in an upper portion of the body and a distal opening in a lower portion of the body. In one embodiment, a portion of the outer periphery of the body is used to engage and press or partially embed into the vaginal wall to anchor the device near the cervical os. In one embodiment, an inflatable inner sac is disposed around the interior of the body near the proximal opening, such that the inner sac defines at least a portion of the proximal opening. The inner sac can expand toward the axial center of the proximal opening to restrict the external portion of the lower cervix. The inner sac can expand from a neutral state to a swollen state, thereby reducing the area of ​​the proximal opening. In other words, when swollen, the inner sac can expand inward to contract the external portion of the cervix. The inner sac may include one or more recessed portions or minimally swollen portions and one or more enlarged portions or expandable portions adjacent to the recessed portions. The inflatable portion, for example, can expand towards the axial center of the proximal opening to contract the cervix, while the recessed portion of the inner sac typically remains uninflated or unexpanded to allow blood flow between the upper and lower (below the inner sac) cervical tissues. Optionally, the cervical control device may include one, two, or more ridges (e.g., a circular ridge) along the inner periphery of the inner sac for gripping or engaging the exterior of the cervix, for example, providing an improved grip around the cervix when the inner sac is inflated.

[0055] In some embodiments, the body of the cervical control device disclosed herein may be a hemispherical body formed in a hemispherical shape, defining a proximal opening in the upper portion of the hemispherical body and a distal opening in the lower portion of the hemispherical body. The diameter and / or area of ​​the proximal opening may be smaller than the diameter and / or area of ​​the distal opening. The dimensions and shape of the exterior of the body at or near the distal opening may be designed to engage the vaginal wall to support the cervical control device within the vagina near the fornix and / or cervical opening. In other embodiments, the body of the device is curved or arcuate, with the radius of its corners ranging from 7 mm to 15 mm at the transition from the inner sheath to the body. The outer wall of the body may be vertical or arcuate with a radius ranging from 20 mm to 50 mm. The height of the body may be, for example, 15-30 mm. In other embodiments, the body may have a partially cubic shape, a pyramidal shape, a partially oval shape (with an elliptical or partially elliptical cross-section), an irregular three-dimensional shape with an asymmetrical cross-section, or any other shape suitable for placement around the cervix and engaging the vaginal wall.

[0056] Additionally or alternatively, the inner sac of the cervical control device disclosed herein can expand radially inward toward the axial center of the proximal opening and downward away from the transverse plane of the proximal opening and away from the uterus when the inner sac expands around the cervix. The radially inward expansion of the inner sac serves, for example, to contract the external cervix, while the downward expansion serves to pull or push the cervix downward away from the uterus.

[0057] Additionally or alternatively, the inner sheath may include two or more adjacent pouches, the pouches being positioned, shaped, and sized such that, when one or more inflatable pouches are inflated, the inner sheath expands radially inward and / or downward away from the transverse plane of the proximal opening. For example, the inner sheath may include a first inflatable pouch coaxial with the proximal opening and a second inflatable pouch coaxial with both the first inflatable pouch and the proximal opening. In one embodiment, the inner sheath may inflate from a neutral state to an inflated state, in which portions of the inner sheath may expand radially inward toward the axial center of the proximal opening and downward away from the transverse plane of the proximal opening and away from the uterus, thereby applying a downward force to the exterior of the cervix.

[0058] Additionally or alternatively, the radial cross-section of the inner cuff of one or more cervical control devices disclosed herein may be formed to have a non-uniform wall thickness, such that, upon expansion, the arrangement of the non-uniform wall thickness of the cuff causes the inner cuff to expand both radially inward and downward away from the transverse plane of the proximal opening.

[0059] Additionally or alternatively, the cervical control device disclosed herein may include an annular ring located near the upper (proximal) portion of the main body. The annular ring may extend upward in a transverse plane away from the proximal opening. When placing the device in a patient's vagina, the annular ring may be configured to first receive the lower end of the cervix and then guide the cervix into the proximal opening and internal passage, which can help the provider to correctly position the device near and around the cervix.

[0060] The valve disclosed herein can detachably receive a portion of an inflation device (e.g., a pump and / or syringe needle) operable to inflate the internal and / or positioning balloon without requiring removal of the cervical control device from the patient's vagina and / or removal of the cervical control device from the cervix. The valve can be configured to minimize fluid backflow after fluid has been directed into the internal and / or positioning balloon.

[0061] In yet another embodiment, the cervical control device disclosed herein may include a second inflatable annular balloon (also referred to herein as a “positioning balloon”) located near the lower portion and / or outward (convex) bend of the body, for example, near the distal opening. The positioning balloon may inflate outward from the axial center away from the distal opening, such that the positioning balloon inflates toward and contacts the vaginal wall. The positioning balloon may inflate from a neutral state to an inflated state, in which the outer perimeter of the positioning balloon increases (compared to the outer perimeter in the neutral state) to inflate to contact the vaginal wall and anchor the device thereto. The positioning balloon may be in fluid communication with an inflation medium catheter (e.g., the catheter described herein) to receive or release fluid from the positioning balloon. A single inflation medium catheter may be provided in communication with the distal end of the device and the inner balloon, or dedicated inflation medium catheters may be provided for the positioning balloon and the inner balloon, and / or for each individually controllable pouch of the inner balloon and / or the positioning balloon.

[0062] In several embodiments, a cervical control device and / or system for supporting a patient's cervix may be provided, the cervical control device and / or system including a body sized and shaped for placement in a patient's vagina. The body has an upper portion defining a proximal opening and a lower portion defining a distal opening. The exterior of the body is configured to engage the vaginal wall to support or anchor the cervical control device and / or system near the cervical opening.

[0063] The cervical control device and / or system disclosed herein may include, for example, one or more inflatable annular cuffs located within a body near a proximal opening, with the inner cuff defining at least a portion of the proximal opening. In one embodiment, at least a portion of the inner cuff may inflate from a neutral state to an inflated state, in which the inner cuff both (i) expands radially inward toward the axial center of the proximal opening to constrict the exterior of the cervix and (ii) expands downward away from the transverse plane of the proximal opening and away from the uterus to apply a downward force to the exterior of the cervix.

[0064] In some embodiments, the inner sheath may include one or more recessed portions and one or more expandable portions, the recessed portions and expandable portions being circumferentially spaced apart from each other surrounding the inner sheath. The expandable portions may expand toward the axial center of the proximal opening or downward toward a transverse plane away from the proximal opening. The recessed portions of the inner sheath allow blood to flow from the upper cervical tissue to the lower cervical tissue extending through the inner sheath.

[0065] In another embodiment, the radial cross-section of the inner bladder has a non-uniform wall thickness, such that, based on the material properties of the non-uniform wall thickness, the inner bladder can expand both radially inward and downward along a transverse plane away from the proximal opening during expansion.

[0066] In another embodiment, the inner sleeve may include a plurality of inflatable pouches that are adjacent to each other and coaxial. The plurality of inflatable pouches may be arranged such that, when one or more pouches are inflated, the inner sleeve expands radially inward (towards the axial center of the proximal opening) and / or expands downward in a direction away from the transverse plane of the proximal opening.

[0067] The cervical control system, cervical control device and / or method disclosed herein can be used for, for example, delaying labor, controlling the cervix, supporting a weak cervix, treating cervical insufficiency, treating pelvic organ prolapse, treating incontinence, treating pelvic organ pain or pressure, bleeding and / or bladder disorders.

[0068] This document discloses a kit that includes one or more cervical control devices and / or systems disclosed herein, as well as an inflation device.

[0069] Therefore, the cervical control devices and / or systems described herein provide a customizable, adjustable means of supporting and / or controlling the cervix for patients with high-risk pregnancies and / or pregnancies with complications that may progress to preterm labor (e.g., cervical insufficiency, PROM, PPROM, and / or insufficient cervical mucus plug). The cervical control devices and / or systems disclosed herein include an inner sheath and / or an individually controllable inflatable sac, which allows care providers to apply pressure at desired locations around the patient's cervix at the apex of the fornix. The adjustable nature of the cervical control devices and / or systems disclosed herein allows providers or users to adjust, for example, the amount of pressure applied to the cervix, compress cervical closure, and / or adjust the orientation of the cervix and / or the cervical control device and / or system relative to the cervix and vagina, all without requiring vaginal removal of the cervical control device and / or system, or direct manual manipulation of the cervical control device and / or system via the vagina. The internal and / or positioning balloons disclosed herein may include various dimensional features or structural aspects that cause the internal and / or positioning balloons to expand radially inward toward the cervix and / or downward away from the uterus to exert an inclined, inward and downward force on the cervix.

[0070] These and other objects, advantages, uses and features of this disclosure will become apparent when viewed in conjunction with the accompanying drawings in the description below. Attached Figure Description

[0071] The following figures are for illustrative (exemplary) purposes only and illustrate non-limiting embodiments. Features in the different figures may be combined in multiple embodiments.

[0072] Figure 1 shows a sagittal view of a patient with multiple pregnancies according to some embodiments of the present invention, illustrating the placement of an exemplary cervical control system;

[0073] Figure 2 shows another sagittal view of the patient in Figure 1 according to some embodiments of the present invention, wherein the cervical control system is shown in a cross-sectional side view and the inner sac is in an inflated or swollen state.

[0074] Figure 3 shows a top perspective view of the cervical control system of Figure 1 according to some embodiments of the present invention, which shows the inner sheath in a contracted or neutral state.

[0075] Figure 4 shows a top perspective view of the cervical control system of Figure 1 according to some embodiments of the present invention, which shows the inner sheath in an inflated state.

[0076] Figure 5 shows a cross-sectional side view of the cervical control system of Figure 1 taken along the VV line of Figure 3 according to some embodiments of the present invention, which shows the inner sheath in a contracted state.

[0077] Figure 6 shows another cross-sectional side view of the cervical control system of Figure 1, taken along line VI-VI of Figure 4 according to some embodiments of the present invention, which shows the inner sheath in an inflated state.

[0078] Figure 7 shows a cross-sectional side view of another exemplary cervical control system according to some embodiments of the present invention, in which the inner sheath is shown in a contracted or neutral state;

[0079] Figure 8 shows a cross-sectional side view of the cervical control system of Figure 7 according to some embodiments of the present invention, which shows the inner sheath in a swollen or inflated state.

[0080] Figure 9 shows a radial cross-sectional side view of a portion of another inner sheath for a cervical control system according to some embodiments of the present invention;

[0081] Figure 10A shows a radial cross-sectional side view of a portion of another inner sheath of a cervical control system in a neutral state according to some embodiments of the present invention;

[0082] Figure 10B shows a radial cross-sectional side view of a portion of the inner bladder of Figure 10A in an inflated state according to some embodiments of the present invention;

[0083] Figure 11 shows a radial cross-sectional side view of a portion of another inner sheath for a cervical control system according to some embodiments of the present invention;

[0084] Figure 12 shows a radial cross-sectional side view of a portion of another inner sheath in a contracted or neutral state for a cervical control system according to some embodiments of the present invention.

[0085] Figure 13 shows a radial cross-sectional side view of a portion of the inflatable bladder of Figure 12 in an inflated or expanded state, according to some embodiments of the present invention.

[0086] Figure 14 shows a cross-sectional side view of another cervical control system according to some embodiments of the present invention, which shows the inner sheath in a contracted or neutral state.

[0087] Figure 15 shows another cross-sectional side view of the cervical control system of Figure 14 according to some embodiments of the present invention, which shows the inner sheath in a swollen or expanded state.

[0088] Figure 16 shows a cross-sectional side view of the cervical control system of Figure 14 according to some embodiments of the present invention, which shows the position around the patient's cervix at the top of the fornix and shows the inner sheath in a contracted state.

[0089] Figure 17 shows a cross-sectional side view of the cervical control system of Figure 16 according to some embodiments of the present invention, which shows the patient's cervix extending from the top of the fornix into the opening formed by the inner sac;

[0090] Figure 18 shows a cross-sectional side view of the cervical control system of Figure 17 according to some embodiments of the present invention, wherein the inner sac is inflated and the inner sac engages or compresses the outside of the patient's cervix at the top of the fornix.

[0091] Figure 19 shows a cross-sectional side view of another exemplary cervical control system according to some embodiments of the present invention, which is shown as having a positioning balloon in a contracted or neutral state.

[0092] Figure 20 shows a cross-sectional side view of the cervical control system of Figure 19 according to some embodiments of the present invention, which shows the positioning balloon in an inflated or expanded state.

[0093] Figure 21 shows a radial cross-sectional side view of a portion of an exemplary cervical control system according to some embodiments of the present invention, the cervical control system including a pair of positioning balloons in a contracted or neutral state;

[0094] Figure 22 shows a radial cross-sectional side view of the positioning balloon of Figure 21 in an inflated or expanded state according to some embodiments of the present invention.

[0095] Figure 23 shows a top perspective view of another cervical control system according to some embodiments of the present invention, in which the inner sheath and the positioning balloon are shown, both of which are in a contracted or neutral state.

[0096] Figure 24 shows a bottom view of the cervical control system of Figure 23 according to some embodiments of the present invention;

[0097] Figure 25 shows a top perspective view of another cervical control system according to some embodiments of the present invention, in which the inner sheath and the positioning balloon are shown, both of which are in a contracted or neutral state.

[0098] Figure 26 shows an exploded side perspective view of the cervical control system of Figure 25 according to some embodiments of the present invention;

[0099] Figure 27 shows a anatomical view of the components of the cervical control system of Figure 25 taken along section lines XXVII-XXVII of Figure 25 according to some embodiments of the present invention.

[0100] Figure 28 shows another top perspective view of the cervical control system of Figure 25 according to some embodiments of the present invention, which shows the inner sheath in a swollen or inflated state.

[0101] Figure 29 shows a cross-sectional side view taken along section line XXVI-XXVI of Figure 25 according to some embodiments of the present invention, which shows that both the inner sheath and the positioning balloon are in a contracted state.

[0102] Figure 30 shows another cross-sectional side view taken along section line XXVI-XXVI of Figure 25 according to some embodiments of the present invention, which shows the inner sheath in an inflated state and the positioning balloon in a contracted state.

[0103] Figure 31 shows a cross-sectional side view taken along line XXXI-XXXI of Figure 25 according to some embodiments of the present invention, which shows that both the inner bladder and the positioning balloon are inflated.

[0104] Figure 32A shows another cross-sectional side view of the cervical control system of Figure 29 according to some embodiments of the present invention, and shows a four-lumen tube inflation system coupled to a valve system for inflating an inner sheath and / or positioning balloon inserted therein.

[0105] Figure 32B shows an enlarged view of the area marked XXXIIA in Figure 32A according to some embodiments of the present invention;

[0106] Figure 32C shows a side perspective view of the four-lumen tube of Figure 32A according to some embodiments of the present invention;

[0107] Figure 33 shows a sagittal view of a singleton pregnancy patient according to some embodiments of the present invention, including a cross-sectional side view of the cervical control system of Figure 25 supporting the patient's cervix in the patient's vagina.

[0108] Figure 34 shows a radial cross-sectional side view of the inner sheath of the cervical control system of Figure 25 according to some embodiments of the present invention;

[0109] Figure 35 shows a top view of another cervical control system according to some embodiments of the present invention, wherein an inner sheath and a positioning balloon are shown, both of which are in a contracted or neutral state.

[0110] Figure 36 shows a side perspective view of another cervical control system according to some embodiments of the present invention, wherein the inner sheath is in a contracted or neutral state.

[0111] Figure 37 shows a cross-sectional side perspective view of the cervical control system of Figure 36 taken along line XXXVII-XXXVII of Figure 36 according to some embodiments of the present invention.

[0112] Figure 38 shows a radial cross-sectional side view of a first exemplary wedge according to some embodiments of the present invention;

[0113] Figure 39 shows a radial cross-sectional side view of a second exemplary wedge according to some embodiments of the present invention;

[0114] Figure 40 shows a radial cross-sectional side view of a third exemplary wedge according to some embodiments of the present invention;

[0115] Figure 41 shows a radial cross-sectional side view of a fourth exemplary wedge according to some embodiments of the present invention;

[0116] Figure 42 shows a radial cross-sectional side view of a fifth exemplary wedge according to some embodiments of the present invention;

[0117] Figure 43 shows a front view of a sixth exemplary wedge according to some embodiments of the present invention;

[0118] Figure 44 shows a front view of a seventh exemplary wedge according to some embodiments of the present invention;

[0119] Figure 45 shows a front view of an eighth exemplary wedge according to some embodiments of the present invention;

[0120] Figure 46 shows a front view of a ninth exemplary wedge according to some embodiments of the present invention;

[0121] Figure 47 shows a front view of a tenth exemplary wedge according to some embodiments of the present invention;

[0122] Figure 48 shows a front view of an eleventh exemplary wedge according to some embodiments of the present invention;

[0123] Figure 49 shows a front view of a twelfth exemplary wedge according to some embodiments of the present invention;

[0124] Figure 50 shows a front view of a thirteenth exemplary wedge according to some embodiments of the present invention;

[0125] Figure 51 shows a side perspective view of another cervical control system according to some embodiments of the present invention, in which an inner sheath and a positioning balloon are shown, both of which are in a contracted or neutral state.

[0126] Figure 52 shows a side cross-sectional view of the cervical control system of Figure 51 taken along line LII-LII of Figure 51 according to some embodiments of the present invention.

[0127] Figure 53 shows a side cross-sectional view of the cervical control system of Figure 52 according to some embodiments of the present invention, which shows the inner sheath in a contracted state and the positioning balloon in an inflated or expanded state.

[0128] Figure 54 shows another cross-sectional side perspective view of the cervical control system of Figure 53 according to some embodiments of the present invention, which shows the tube and valve assembly for inflating the top and positioning balloon;

[0129] Figure 55 shows a bottom perspective view of another cervical control system according to some embodiments of the present invention, which is shown as having an inner sheath and a positioning balloon in a contracted or neutral state.

[0130] Figure 56 shows a bottom sectional view of the cervical control system of Figure 55 according to some embodiments of the present invention. The bottom sectional view is taken below and perpendicular to the axial center of the inner sheath of the cervical control system.

[0131] Figure 57 shows a partial sectional top perspective view taken along line LVII-LVII of Figure 55 according to some embodiments of the present invention, which shows the internal components of the complete cervical control system to show the internal structure.

[0132] Figure 58 shows a perspective view of a system including a cervical control system, a conduit, and a valve system according to some embodiments of the present invention;

[0133] Figure 59 shows an exploded perspective view of the system of Figure 58 according to some embodiments of the present invention;

[0134] Figure 60 shows a detailed exploded view of the system of Figure 58 according to some embodiments of the present invention;

[0135] Figure 61A shows a cross-sectional view of a valve housing including a pressure gauge in a first position, taken along section lines 61A, 61B, and 61C of Figure 61D according to some embodiments of the present invention.

[0136] Figure 61B shows a cross-sectional view of a valve housing including a pressure gauge in a second position, taken along section lines 61A, 61B, and 61C of Figure 61D according to some embodiments of the present invention.

[0137] Figure 61C shows a cross-sectional view of a valve housing including a pressure gauge in a third position, taken along section lines 61A, 61B, and 61C of Figure 61D according to some embodiments of the present invention.

[0138] Figure 61D shows a cross-sectional perspective view of a valve housing with pressure gauges from Figures 61A-61C according to some embodiments of the present invention;

[0139] Figure 61E shows a side sectional view of a pressure gauge arranged within a valve housing of Figure 61D according to some embodiments of the present invention;

[0140] Figure 62A shows a perspective view of a system according to some embodiments of the present invention, the system including a cervical control system having an inner sheath and a positioning balloon in a neutral and contracted state, and a valve housing having a syringe inserted into a valve in the valve housing, the valve being associated with the positioning balloon.

[0141] Figure 62B shows a side sectional view of the system shown in Figure 62A according to some embodiments of the present invention, and illustrates the fluid communication path from the syringe to the positioning balloon;

[0142] Figure 63A shows a perspective view of the system of Figure 62A according to some embodiments of the present invention, wherein the positioning balloon is in an inflated state, a pressurized state, and / or an inflated state;

[0143] Figure 63B shows a cross-sectional view of the system of Figure 63A according to some embodiments of the present invention;

[0144] Figure 64A shows a cross-sectional view of a portion of a cervical control system according to some embodiments of the present invention, the cervical control system having an inner sheath and a positioning balloon in a neutral or contracted state.

[0145] Figure 64B shows a cross-sectional view of the cervical control system of Figure 64A according to some embodiments of the present invention, wherein the inner sheath is in a neutral or contracted state and the positioning balloon is in an inflated state.

[0146] Figure 65A shows a cross-sectional view of add according to some embodiments of the present invention, wherein the cervix is ​​located within the internal channel of the cervical control system and the inner sheath of the cervical control system is in a neutral state.

[0147] Figure 65B shows a cross-sectional view of the cervical control system of Figure 65B according to some embodiments of the present invention, wherein the cervix is ​​located within the internal channel of the cervical control system, and the inner sheath of the cervical control system is in a state of inflation, expansion, and / or pressure.

[0148] Figure 66 shows a side sectional view of a portion of a cervical control system according to some embodiments of the present invention, which shows the inner sheath and the lumen defined by the flexible membrane of the inner sheath.

[0149] Figure 67A shows a top view of a cervical control system according to some embodiments of the present invention, the cervical control system having an inner sheath and a positioning balloon in a neutral state, and the cervix positioned within the internal channel of the cervical control system;

[0150] Figure 67B shows a top view of the cervical control system of Figure 67A according to some embodiments of the present invention, wherein the cervix is ​​located within the internal channel of the cervical control system, the inner sheath is in a pressurized or inflated state, and the positioning balloon is in a neutral state.

[0151] Figure 67C shows a top view of the cervical control system of Figure 67A according to some embodiments of the present invention, wherein the cervix is ​​located within the internal channel of the cervical control system, and the inner sheath and the positioning balloon are both in a pressurized or inflated state.

[0152] Figure 68A shows a top view of the cervical control system of Figures 67A-67B according to some embodiments of the present invention;

[0153] Figure 68B shows a 90-degree cross-section of the cervical control system of Figure 68A according to some embodiments of the present invention;

[0154] Figure 69A shows a top view of a valve housing for a single valve according to some embodiments of the present invention;

[0155] Figure 69B shows a bottom perspective view of the valve housing of Figure 69A according to some embodiments of the present invention;

[0156] Figure 69C shows a cross-sectional view of the valve housing of Figure 69A according to some embodiments of the present invention;

[0157] Figure 69D shows a top view of a system including a cervical control system and the valve housing of Figure 69A according to some embodiments of the present invention;

[0158] Figure 69E shows a cross-section of a first embodiment of the system of Figure 69D taken along section lines 69E or 69F of Figure 69D according to some embodiments of the present invention.

[0159] Figure 69F shows a cross-section of a second embodiment of the system of Figure 69D taken along section lines 69E or 69F of Figure 69D according to some embodiments of the present invention;

[0160] Figure 69G shows an exploded side view of the system of Figure 69E or Figure 69F according to some embodiments of the present invention;

[0161] Figure 69H shows an assembled side view of the system of Figure 69E or Figure 69F according to some embodiments of the present invention;

[0162] Figure 69I shows a cross-sectional view of the system of Figure 69E or Figure 69F according to some embodiments of the present invention, wherein the inflation source is positioned together with the valve in the valve housing;

[0163] Figure 70A shows a top view or proximal view of an exemplary cervical control system according to some embodiments of the present invention;

[0164] Figure 70B shows a bottom view or a distal view of the cervical control system of Figure 70 according to some embodiments of the present invention.

[0165] Figure 70C shows a block diagram illustrating the cervical control system of Figures 70A and 70B in situ within a patient according to some embodiments of the present invention;

[0166] Figure 71A shows a bottom perspective view of an exemplary cervical control system including an internal channel according to some embodiments of the present invention;

[0167] Figure 71B shows a cross-sectional view of the cervical control system of Figure 71A according to some embodiments of the present invention;

[0168] Figure 72A shows a top view of a three-port valve housing according to some embodiments of the present invention;

[0169] Figure 72B shows a bottom view of the three-port valve housing of Figure 72A according to some embodiments of the present invention;

[0170] Figure 73 shows a cross-sectional view of a three-lumen tube according to some embodiments of the present invention;

[0171] Figure 74A shows an exploded view of a component according to some embodiments of the present invention, the component including the cervical control system of Figures 71A and 71B, the three-port valve housing of Figures 72A and 72B, and the three-lumen tube of Figure 73;

[0172] Figure 74B shows a close-up of a portion of an exploded view of Figure 74A according to some embodiments of the present invention;

[0173] Figure 74C shows the fully assembled state of the components of Figure 74A according to some embodiments of the present invention;

[0174] Figure 75A shows an exploded side view of a system according to some embodiments of the present invention, the system including the cervical control system of Figures 71A and 71B, the three-port valve housing of Figures 72A and 72B, and the three-lumen tube of Figure 73.

[0175] Figure 75B shows a rear perspective view of the system of Figure 75A according to some embodiments of the present invention;

[0176] Figure 75C shows a rear perspective view of the system of Figure 75A after complete assembly, with the valve disposed in the valve housing, according to some embodiments of the present invention.

[0177] Figure 76A shows an exploded rear view of the three-port valve housing, micropump assembly, and reservoir assembly of Figure 72 according to some embodiments of the present invention.

[0178] Figure 76B shows a front perspective exploded view of the three-port valve housing and micropump assembly of Figure 76A according to some embodiments of the present invention, wherein the reservoir is located within the micropump assembly.

[0179] Figure 76C shows a rear perspective view of the three-port valve housing and micropump assembly of Figure 76A according to some embodiments of the present invention, wherein the reservoir is located within the micropump assembly;

[0180] Figure 77 shows a side view of a component according to some embodiments of the present invention, the component including the cervical control system of Figures 71A and 71B, the three-port valve housing of Figures 72A and 72B, the three-lumen tube and syringe of Figure 73;

[0181] Figure 78A shows a bottom view of the top of a mold according to some embodiments of the present invention;

[0182] Figure 78B shows a bottom view of the waist of a mold according to some embodiments of the present invention;

[0183] Figure 78C shows a top view of the waist of a mold according to some embodiments of the present invention;

[0184] Figure 78D shows a cross-sectional view taken along the bisecting line 78D of the top of the mold in Figure 78A according to some embodiments of the present invention;

[0185] Figure 78E shows a cross-sectional view taken along the bisecting line 78E of the waist of the mold in Figure 78B, according to some embodiments of the present invention.

[0186] Figure 78F shows a top view of the bottom mold according to some embodiments of the present invention;

[0187] Figure 78G shows a cross-sectional view taken along the bifurcation line 78G of the bottom mold of Figure 78F according to some embodiments of the present invention;

[0188] Figure 78H shows a cross-sectional view of the components of the top mold of Figure 78A, the mold waist of Figures 78B and 78C, and the bottom mold of Figure 78F according to some embodiments of the present invention.

[0189] Figure 78I shows an exploded perspective view of the component of Figure 78H according to some embodiments of the present invention, the component having a molded cervical control system;

[0190] Figure 78J shows an exploded component of Figure 78I and a cross-sectional view of a molded cervical control system according to some embodiments of the present invention.

[0191] Figure 78K shows a bisection view of the cervical control system of Figure 78I according to some embodiments of the present invention;

[0192] Figure 78L shows an oblique cross-sectional view of the cervical control system of Figure 78I according to some embodiments of the present invention;

[0193] Figure 78M shows a bisection view of a cervical control system according to some embodiments of the present invention, wherein the inner sheath is in a fully assembled state.

[0194] Figure 79 shows a flowchart of some embodiments of the present invention, illustrating a process of using the cervical control system, system and / or device disclosed herein;

[0195] Figure 80A shows a sagittal view of a patient with intact fetal membranes and normal amniotic fluid levels according to some embodiments of the present invention;

[0196] Figure 80B shows a sagittal view of a patient with PPROM according to some embodiments of the present invention;

[0197] Figure 80C shows a sagittal view of a patient according to some embodiments of the present invention, and illustrates how the cervical control system can be placed around the patient's cervix by means of a finger;

[0198] Figure 80D shows a sagittal view of a patient according to some embodiments of the present invention, and illustrates how to use forceps to position the cervical control system inside the patient's vagina and around the patient's cervix;

[0199] Figure 80E shows a sagittal view of the patient and illustrates how, according to some embodiments of the invention, a syringe-type source of inflation medium is used to inflate and / or deflate the inner sheath and / or positioning balloon of an in situ cervical control system.

[0200] Figure 80F shows a sagittal view of the patient in Figure 80E according to some embodiments of the present invention, wherein the inner sac is inflated such that it engages with and closes the cervix.

[0201] Figure 80G shows a sagittal view of the patient in Figure 80F according to some embodiments of the present invention, wherein the inner sac is inflated such that it engages and tilts or changes the orientation and angle of the cervix and closes it.

[0202] Figure 80H shows a sagittal view of the patient in Figure 80E according to some embodiments of the present invention, wherein the fluid conduit and valve housing are located inside the patient's vagina;

[0203] Figure 80I shows a sagittal view of a patient according to some embodiments of the present invention, wherein the cervical control system is placed around the patient’s cervix in a position inverted from the position shown in Figure 80H;

[0204] Figure 80J shows a sagittal view of a patient with an intact amniotic membrane and normal amniotic fluid volume according to some embodiments of the present invention;

[0205] Figure 80K shows a sagittal view of a patient with ruptured amniotic membrane according to some embodiments of the present invention, who has lost some amniotic fluid.

[0206] Figure 80L shows a sagittal view of the patient of Figure 80K according to some embodiments of the present invention, wherein a cervical control system has been installed around the patient's cervix to mitigate and restore amniotic fluid leakage caused by rupture of membranes; and

[0207] Figure 81 shows a block diagram of a kit including a cervical control system according to some embodiments of the present invention. Detailed Implementation

[0208] Various embodiments of cervical control devices, systems, and methods of use are now provided with reference to the accompanying drawings and exemplary embodiments described therein, for mitigating or preventing preterm birth caused by, for example, cervical insufficiency (e.g., cervical shortening or incompetence), prolapse, cervical support, etc. In some embodiments, the cervical control device is adjustable to apply pressure around the outside of the cervix and can be used to change the angle of the cervix, which can promote prolonged pregnancy in patients with cervical insufficiency. The cervical control devices disclosed herein may include one or more inflatable (e.g., inflatable) cuffs that apply pressure to the outside of the cervix when inflated. The cervical control device can be adjusted by an operator or user (e.g., a healthcare provider) without requiring removal of the cervical control system and / or device from the patient. In cases where the cervix is ​​partially dilated, dilated to the point where the cervical mucus plug has detached, the cervical control system can be used to compress the cervix to promote the regeneration of the mucus plug, thereby preventing infection from entering the uterus along the cervix. In the case of PROM or PPROM, the cervical control system can be used to compress the cervix to reduce the rate of amniotic fluid loss, thereby helping to promote fetal lung development. The cervical control system disclosed herein can be used minimally invasively to provide support around the lower part of the cervix, thereby supporting the weight of the uterus and fetus, preferably (in one embodiment) with little or no stimulation or pain to the cervix. In other words, the internal and / or positioning balloon can be in a neutral or uninflated state. If the patient's cervix continues to shorten and dilate, and the minimally invasive approach is insufficient to cope, the internal and / or positioning balloon can be inflated, or further inflated, to reduce the proximal opening diameter, thereby providing additional support to the external cervix and providing external pressure around the external cervix to prevent further opening or dilation of the cervix. In this document, the terms "cuff" and "bladder" are used to refer to the inflatable components of some exemplary embodiments of this disclosure, which can be partially or fully annular, including, for example, an "inner cuff," a "positioning balloon," and an "inflatable bladder." Optionally, the internal and / or positioning balloons may be continuously arranged to surround the internal and / or external circumferential arrangement of the cervical control system, or may be intermittently arranged to surround the internal and / or external circumferential arrangement of the cervical control system at intervals, may inflate to define a non-circular or non-uniform opening, and / or may inflate in lateral (e.g., radial) and / or oblique (e.g., non-radial) directions. In some embodiments, the cervical control system disclosed herein can be used to support the cervix, uterus, and fetus even when the internal and / or positioning balloons are in a neutral or uninflated state.

[0209] This document discloses cervical control devices and systems configured to locally dispense substances onto cervical tissue continuously, on demand, and / or periodically in situ, allowing the substances to come into contact with the cervical tissue (e.g., through reapplication) regardless of whether vaginal secretions are flushed or otherwise cleansed the cervix and vagina. Substances dispensed by the cervical control devices and systems disclosed herein include, but are not limited to, medications such as progesterone, saline solution, disinfectants, antibiotics, lubricants, water, chlorhexidine, povidone-iodine, analgesics, and / or lubricants. Using the systems and devices disclosed herein allows clinicians to deliver substances to the cervix without removing and reinserting the device and / or system or disturbing the cervix.

[0210] The discussion of the cervical control systems, cervical control devices, and methods disclosed herein uses the terms "proximal," "top," "distal," and / or "bottom" to refer to portions of the respective systems, devices, and methods oriented in the corresponding figures. In many embodiments, the top and / or proximal portions of the systems and / or devices disclosed herein are intended to be positioned close to the patient's fornix, with the inner sac surrounding a portion of the cervix near the patient's uterus. The bottom and / or distal portions of the cervical control devices and / or systems disclosed herein may refer to portions configured to be oriented away from the patient's uterus and / or having sides and / or edges close to the patient's vaginal opening. It should be understood that the systems and devices disclosed herein can be used in a variety of orientations (i.e., not necessarily the orientation shown in the figures), and in some cases, a portion of the system and / or device labeled proximal or top may actually be placed distally within the patient when the device is inverted, for example, to treat pelvic organ prolapse.

[0211] Components of the cervical control system described and illustrated herein (e.g., inner sheaths and / or positioning balloons) may include one or more flexible membranes (also referred to herein as “walls”) defining one or more lumens configured to receive an inflation medium therein. When the lumen of the disclosed inner sheath is filled with an inflation medium, the respective flexible membrane of the inner sheath expands in one or more directions (e.g., radial, orthogonal, tangential, oblique, and / or downward (i.e., away from the uterus)) to, for example, contact and / or engage, elongate, compress, or otherwise support and / or control the cervix. When the lumen of the disclosed positioning balloon is filled with an inflation medium, the flexible membrane defining its respective lumen expands in one or more preferred directions (e.g., perpendicular to the body of the cervical control system and / or into the vagina) to, for example, fix the cervical control system within the vagina and / or adjust the position and / or orientation of the cervical control system relative to the patient’s cervix, uterus, and / or vagina. Additionally or alternatively, the flexible membranes of the inner sheath and positioning balloon disclosed herein can be selectively inflated and / or contracted to, for example, adjust the degree of cervical compression and / or elongation, the orientation angle of the cervical control system and / or the position and / or orientation of the cervical support device within the vagina, as desired and / or required by physicians, clinicians and / or patients, according to their needs and / or preferences.

[0212] Turning now to the accompanying drawings, Figures 1 and 2 are sagittal views of a pregnant woman, wherein an exemplary cervical control system 100 (also referred to herein as "system 100") is located within the woman's vagina 103, such that a portion of the woman's cervix 101 is located within and supported by system 100, thereby attempting, for example, to treat PPROM, short cervix, and / or prevent preterm labor according to one or more methods disclosed herein. The inner sheath of system 100 may be configured to switch between a neutral or contracted state (e.g., when cervix 101 is located therein) and an inflated state (e.g., when cervix 101 is located therein and supported and / or reinforced by system 100). Figure 3 is a top perspective view of system 100 when the inner sheath is in a contracted or neutral state, and Figure 4 is a top perspective view of system 100 when the inner sheath is in an inflated state.

[0213] System 100 includes a flexible body 102 and an internal channel 170. The flexible body 102 may have a hemispherical or near-hemispherical shape. The internal channel 170 has an upper or proximal opening 104 located near the upper portion of the body 102 / internal channel 170 (as shown in Figures 3-6), and a lower (as shown in Figures 3-6) or distal opening 106 located near the lower portion of the body 102 / internal channel 170 (as shown in Figures 3-6) (see, for example, Figures 5 and 6). In an exemplary embodiment, the diameter of the proximal opening 104 is smaller than the diameter of the distal opening 106, and when the system 100 is placed in the patient's vagina 103 near the base of the cervix, the proximal opening 104 is sized to receive and surround the lower exterior of the patient's cervix 101 (as shown, for example, Figures 1 and 2). For reference purposes, Figures 16-18 provide a sequential illustration of the positioning of the cervix 101 within an internal channel 470 (similar to internal channel 170) of another exemplary cervical control system 400 and the interaction between the cervical control system 400 and the cervix 101 when the system 400 is placed around and engaged with the cervix 101. The outer surface of a portion of the body 102 (e.g., the lower portion of the body 102 near the distal opening 106) may be sized to engage, press against, and / or interact with the inner wall of the patient's vagina 103 (see, for example, Figures 1 and 2) to, for example, hold the system 100 in place and / or help keep a portion of the cervix 101 located within the internal channel 170 closed.

[0214] System 100 includes an inner sac or pouch 108 that can be circumferentially positioned to surround the proximal opening 104 (e.g., as shown in Figures 5 and 6). The outer (e.g., facing the internal passage) surface of the inner sac 108 is expandable (e.g., inflated with a fluid such as saline or air) such that when the cervix 101 is positioned within the internal passage 170 (e.g., see Figures 1 and 2), the inner sac 108 can expand to engage, contract, and / or restrict a portion of the outer surface of the cervix 101 (e.g., the top of the fornix and / or the lower portion of the cervix 101). Figures 3 and 5 show the inner sac 108 in a normal, neutral, or contracted state, while Figures 4 and 6 show the inner sac 108 in an expanded or inflated state, wherein a portion of the inner sac 108 has expanded toward the center of the proximal opening 104. In its inflated state, the inner sac 108 expands and compresses or invades the exterior of the cervix 101 (or a portion thereof), thereby applying external force or pressure to the cervix 101. This helps to close and / or secure the cervical opening or OS (cervical os) to ensure adequate closure, thus delaying labor and fetal delivery and allowing the fetus to remain in the uterus for a longer period (i.e., preventing preterm birth). When the inner sac 108 is inflated, the area of ​​the proximal opening 104 is significantly reduced. A pair of dashed lines are provided between consecutive Figures 3 and 4 and consecutive Figures 5 and 6 to highlight the relative expansion of the inner sac 108 from the neutral state in Figures 3 and 5 to the inflated state in Figures 4 and 6. As shown, this expansion reduces the size or area of ​​the proximal opening 104 and increases the protrusion of the two recessed portions 110. The inner bladder 108 can be fixed (e.g., chemically, vibratoryly, or thermally bonded) to, integrated into (e.g., by integral molding or overmolding) and / or coupled (e.g., by mechanical coupling such as tenon or dovetail joints) to the proximal end of the internal channel 170. Further details regarding the manufacture of the system 100 and / or the inner bladder 108 are shown, for example, in Figures 1-6 and are discussed herein.

[0215] As shown in Figures 3 and 4, the inner sheath 108 includes two recessed portions 110 on opposite sides of the proximal opening 104 and two expandable portions 112 formed on the other opposite side of the proximal opening 104 between the recessed portions 110. In the neutral state, the inner sheath 108 defines a generally circular shape (see, for example, Figure 3). As the inner sheath 108 expands, the expandable portions 112 expand toward the axial center of the proximal opening 104, while the recessed portions 110 remain substantially stationary, unchanged, or do not expand (as shown, for example, in Figure 4). Thus, in the expanded state, the recessed portions 110 and the expandable portions 112 cooperate to form a non-circular inner periphery of the inner sheath 108 (Figure 4). When the inner sheath 108 is in the expanded state, the area of ​​the proximal opening 104 is reduced compared to the area of ​​the inner sheath 108 in the neutral state. The recessed portion 110 is located within the inner sheath 108 to accommodate the portion of the cervix 101 containing the main blood vessels supplying blood to the cervical tissue (e.g., the distal end of the cervix), and the recessed portion 110 is configured to minimize compression of the cervical tissue so that blood flow through these blood vessels is not impaired when other cervical tissue is compressed by the expansion of the inner sheath 108.

[0216] As shown sequentially in Figures 5 and 6, when the inner sac 108 inflates, it expands both radially inward toward the center of the proximal opening 104 and downward relative to the transverse plane of the proximal opening 104 (as shown in Figure 6). In other words, when the system 100 is placed in the vagina such that the cervix 101 is located within the internal passage and the inner sac 108 inflates, the inflating of the inner sac 108 can contract a portion of the outer surface of the cervix 101 while applying a downward force to the cervix 101 (e.g., away from the uterus 105). The downward angle of the inflating inner sac 108 can be used to pull or push the cervix 101 downward away from the uterus 105, thereby helping to hold the inner sac 108 in place during use (e.g., reducing or preventing the cervix from slipping out of the inner sac 108 due to, for example, the increase in volume of the inner sac during inflating and / or the shortening of the cervix over time). In other words, the combination of lateral and downward contractile forces acting on the cervix 101 can more effectively engage and constrain the exterior of the cervix 101 compared to applying contractile forces only in the lateral or downward direction. The expansion angle of the inner sheath 108 in the lateral plane away from the proximal opening 104 can be selected from a range between 0.5 degrees (0.5°) and 89.5 degrees (89.5°).

[0217] In some embodiments, the entire inner sheath 108 may be formed of the same material (e.g., flexible silicone). In some cases, the entire inner sheath 108 may have different thicknesses (e.g., the thickness of the flexible silicone in the recessed portion 110 is greater than the thickness of the flexible silicone in the expandable portion 112). Optionally, different portions of the inner sheath 108 (e.g., the recessed portion 110 and the expandable portion 112) may be formed of different materials (e.g., the expandable portion 112 may include flexible silicone, while the recessed portion 110 may include medical-grade plastic), and / or the different portions 110 and 112 of the inner sheath 108 may be formed of materials with different compositions (e.g., the expandable portion 112 may include flexible silicone, while the recessed portion 110 may include semi-rigid silicone with a higher hardness than the silicone in the expandable portion).

[0218] In some embodiments, system 100 includes a raised annular edge, ridge, or labial edge 114 (referred to herein as edge 114) positioned near the upper portion (oriented as in Figures 3-6) or proximal portion of body 102. Edge 114 may extend upward over or protrude from the inner cuff 108 (see, for example, Figures 5 and 6) and may be configured to be positioned toward uterus 105 when system 100 is in situ (see Figures 1 and 2). Edge 114 may define the uppermost or proximal edge of system 100 and may include an inclined outer wall 114a extending from the top of edge 114 (oriented as in Figures 5 and 6) toward an interface connecting to the outside of body 102, and an inclined inner wall 114b extending from the top of edge 114 toward the upper edge of inner cuff 108 (oriented as in Figures 5 and 6). The configuration, size, and / or shape of the inclined inner wall 114b can facilitate the entry of the cervix 101 into the proximal opening 104 and the internal passage 170 by introducing the end of the cervix 101 along the inclined inner wall 114b in a funnel-like or guide-like manner during the placement of the system 100 around the cervix 101 in the vagina 103. The inclined inner wall 114b can be at an angle of, for example, 20-85 degrees (20-85°) or between about 5 degrees (5°) and about 60 degrees (60°) relative to the longitudinal axis of the system 100 (shown as a vertically oriented dashed line superimposed on Figures 5 and 6) to guide the cervix 101 into the internal passage 170, for example, when the system 100 is placed in situ (see Figures 1 and 2). In some embodiments, the edge 114 may extend 1-1-mm above the upper edge (as oriented in Figures 3-6) or the proximal edge of the inner sheath 108.

[0219] In some embodiments, system 100 may include an inflatable medium conduit 116 configured to be in fluid communication with an inner bladder 108 via an inlet 120. As shown in Figures 5 and 6, the conduit 116 may be located on an outer surface of the body 102 and / or embedded within the wall 118 of the body 102. According to one or more methods disclosed herein, fluid introduced into the conduit 116 via the inlet 120 may be transferred to the inner bladder 108 and inflated, and fluid withdrawn from the inner bladder 108 via the conduit 116 and the inlet 120 may cause the inner bladder 108 to contract during use. The inlet 120 may be located on the exterior or surface of the body 102, such that the inlet 120 may be accessed and / or detachably coupled to an inflatable device (e.g., a syringe or tube) (not shown) for adding and / or removing fluid from the conduit 116 and / or the inner bladder 108. In this way, the inner cuff 108 can be inflated and / or contracted in situ without requiring the system 100 to be removed from the vagina 103 during treatment. Optionally, a valve (not shown) may be provided at or near the inlet 120 to regulate the flow of fluid into and out of the catheter 116. For example, a y-valve system (e.g., y-valve system 826 shown in Figures 29 and 30 and discussed below) may be used as the valve for the inlet 120. Additionally or alternatively, the inflation / contraction device (e.g., inflation / contraction device 827) includes a tube 828 and a valve 830 (as shown in Figure 32, which will be described in further detail below) that can be used to inflate and / or contract the inner cuff 108.

[0220] In some of the illustrated embodiments, the inner sheath 108 expands downward or toward a transverse plane away from the proximal opening. Additionally or alternatively, the inner sheath 108 may expand substantially along the transverse plane of the proximal opening, for example, as shown in exemplary embodiments of the cervical control systems 400 and 800 illustrated in Figures 14-18 and 29-30, respectively, and described in further detail below. For example, the inner sheath 808 may be configured to expand in a purely radial and concentric manner (as illustrated in the sequential schematic diagram of system 800 in Figures 29 and 30).

[0221] Figures 7 and 8 provide cross-sectional views of another cervical control system 200 similar to system 100 described above, but including some alternative and / or additional components and functions. Similar to system 100, system 200 includes a body 202, a proximal opening 204, a distal opening 206, an inner sheath 208, a raised annular edge 214, an internal passage 270, and an inflatable medium conduit 216 located within the body wall 220. Furthermore, the cervical control system 200 includes a plurality of mechanical engagement elements 222, which are positioned along the inner surface or periphery of the inner sheath 208, for example, in the form of one or more annular ridges, wedges, and / or teeth, and can extend into the internal passage 270. Mechanical engagement element 222 may be configured to engage with cervical tissue to help hold the cervical control system in place and / or prevent unintentional movement (e.g., disengagement from the cervix 101) of the cervical control system 200 due to, for example, a low coefficient of friction between the cervical control system 200 and the cervix 101, which may be caused by, for example, bodily fluids (e.g., secretions and mucus) present on and around the cervix 101 and the vagina 103. In some embodiments, mechanical engagement element 222 may be configured to clamp the outside of the cervix 101, which helps to hold the cervix 101 in an elongated and / or closed state and / or reduce or prevent the cervix 101 from slipping out of the inner sheath 208. In some embodiments, the cervical control system 200 may include multiple rows of mechanical engagement elements 222 configured such that when the inner sheath 208 expands, a compressive force is directed to the cervix 101 through the expanded inner sheath 208. This compressive force is substantially concentrated on the edges of one or more mechanical engagement elements 222, thereby facilitating engagement between the mechanical engagement elements 222 and the cervix 101, such that, for example, the inner sheath 208 can be secured in place regardless of the coefficient of friction between the cervix 101 and the inner sheath 208.

[0222] In some embodiments, one or more mechanical engagement elements 222 may include a ridge or extension that continuously surrounds the entire inner circumference of the inner sheath 208. Additionally or alternatively, one or more mechanical engagement elements 222 may include individual segments or extensions positioned along and extending from and / or pressed into the outer surface of the inner sheath 208, such as the segmented wedges shown by the cervical control systems 1000 and 1100 of Figures 36-37 and 51-54 and discussed herein. When the mechanical engagement element 222 includes segmented ridges, the ends of each ridge may be chamfered or tapered to improve comfort and / or concentrate more of the pressure from the inner sheath 208 onto a smaller surface area in contact with the cervix 101.

[0223] The mechanical engagement element 222 may extend from and / or be pressed into the outer surface of the inner sheath 208 by approximately 0.1 mm to 10 mm, and in many embodiments, it may extend from and / or be pressed into the outer surface of the inner sheath 208 by approximately 1.5 mm to 6 mm or 3 mm. In some cases, the mechanical engagement element 222 may be formed during the manufacture of the inner sheath 208, and / or may be integrally formed or molded with the inner sheath 208 from a material similar to the inner sheath 208 (e.g., flexible silicone). Additionally or alternatively, the mechanical engagement element 222 may be formed from a material different from the inner sheath 208, such as a rigid polymer (e.g., polyetheretherketone (PEEK)), silicone with a higher hardness than that used for the inner sheath 208, and / or a semi-flexible metal (e.g., 316L stainless steel). In these embodiments, the mechanical coupling element 222 can be fixed to the outer surface of the inner sheath 208, and / or can be formed simultaneously with the inner sheath 208 during the manufacturing process of the inner sheath 208 and / or the mechanical coupling element 222. When the mechanical coupling element 222 is formed separately from the inner sheath 208, the mechanical coupling element 222 and the inner sheath 208 can be adhered to the outer surface of the inner sheath 208 by, for example, overmolding processes, adhesive (e.g., chemical, thermal, and / or vibration) processes, and / or by fastening processes using mechanical fasteners (e.g., snap-fits or clips).

[0224] In some embodiments, one or more cervical control systems disclosed herein may include an inner cuff that utilizes various structural and / or geometric features to achieve expansion in a desired (e.g., downward) direction relative to the transverse plane of its respective proximal opening, which will be discussed in further detail below. For example, in some embodiments (see, for example, Figures 9-13 and the discussion below), the inner cuff may be formed with a non-uniform wall thickness along its radial cross-section, and upon expansion, the inner cuff may expand in the direction of the thickest portion of the wall (i.e., the desired expansion direction). Continuing this example, sequential Figures 12 and 13 depict the expansion of an exemplary inner cuff along the desired expansion direction, wherein the inner cuff expands downward (as in the orientation in Figures 9-13) at the thickest portion of the inner cuff wall. In embodiments having an inner cuff forming a non-circular proximal opening, for example, the expanded portion of the inflated inner cuff may have a non-uniform wall thickness, while the recessed portion may have a substantially uniform wall thickness.

[0225] Figure 9 is a cross-sectional view of a portion of a cervical control system similar to cervical control system 100 or 200, which includes an exemplary inner sheath 300 with variable wall thickness, coupled to the proximal portion of the wall 302 of the cervical control system (e.g., system 100 or 200 described above) shown in the cross-sectional view of Figure 9. The inner sheath 300 includes a main inflatable sac or chamber 303 defined by upper and lower thin-walled portions 304, with a thick-walled portion 306 between the thin-walled portions 304 located at the proximal portion of the inner sheath 300. The upper and lower thin-walled portions 304 may be generally parallel to each other and parallel to the transverse plane of the proximal opening formed by the inner sheath 300 (not shown), similar to proximal openings 104 and 204. When the inner bladder 300 includes flexible silicone, due to the expansion characteristics of the flexible silicone, when the inner bladder 300 is inflated, the thick-walled portion 306 will expand more than the thin-walled portion 304, and this difference in expansion can effectively cause the bladder 300 to expand radially toward the center of the proximal opening and downward toward the transverse plane away from the proximal opening in the desired expansion direction.

[0226] In other words, during the inflation process, the thin-walled portion 304 may initially expand faster than the thick-walled portion 306 until each thin-walled portion 304 reaches its maximum expansion, at which point the thin-walled portion 304 will no longer expand, and the remaining expansion of the inner bladder 300 will occur at the thick-walled portion 306. Example wall thicknesses of the inner sheath 300 include thin-walled portions 304 ranging from approximately 0.004 inches to 0.060 inches (e.g., 0.004–0.008 inches, 0.005–0.010 inches, 0.010–0.015 inches, 0.015–0.020 inches, 0.020–0.040 inches, 0.020–0.060 inches, and overlapping ranges therein), and thick-walled regions 306 ranging from approximately 0.010 inches to 0.100 inches (e.g., 0.01–0.03 inches, 0.03–0.07 inches, 0.07–0.1 inches, and overlapping ranges therein). In one embodiment, the different portions (e.g., thin-walled portions 304 and thick-walled portions 306) may be formed of silicone with different hardness, thereby further facilitating the expansion of the sheath 300 in the desired direction. In some cases, the selected wall thickness of the thin-walled portion 304 and / or the thick-walled portion 306 may depend on the material hardness grade or hardness of the material used to manufacture the inner bladder 300. For example, when the inner bladder 300 comprises silicone, the selected wall thickness may depend on the hardness of the silicone.

[0227] Figures 10A and 10B are cross-sectional views of a portion of a cervical control system similar to cervical control system 100 or 200, which includes an exemplary inner sheath 310 with a different wall thickness, and show the inner sheath 310 coupled to the proximal portion of the wall 312 of the main body of the cervical control system when the inner sheath 310 is in a neutral state (Figure 10A) and an inflated state (Figure 10B). The inner sheath 310 has a structure similar to that of sheath 300 and includes a main inflatable sac or chamber 313, a thin-walled portion 314, and a thick-walled portion 316, which function in a manner substantially identical to the corresponding features of the inner sheath 300. Furthermore, the inner sheath 310 includes a pair of ridges, wedges, or teeth 318, which are structurally and functionally similar to the mechanical engagement element 222 of the cervical control system 200 described above (as shown in Figures 7 and 8). The inner bladder 310 also includes a pair of curved wall segments 320 located in corresponding thin-walled portions 314 (Figure 10). In a neutral, uninflated state (see Figure 10A), the curved wall segments 320 of the inner bladder 310 maintain their curved shape (as shown in Figure 10A). When the inner bladder 310 inflates, the curved wall segments 320 extend and flatten to provide initial inflation of the inner bladder 310 as shown in Figure 10B, which allows the inner bladder 310 to expand radially toward the center of the proximal opening and downward (as shown in Figures 10A and 10B), relative to the upper reference line 301 and the lower reference line 305 (as shown in Figures 10A and 10B). The angle between the upper reference line 301 and the upper thin-walled portion 314 when in the neutral state. It can be approximately 0-6 degrees, and the angle between the lower reference line 305 and the lower thin-walled portion 314 is... It can be approximately 0-6 degrees Celsius.

[0228] Once the inner bladder 310 inflates due to the influx of the inflation medium into and / or being pushed into the inner cavity 313, the curved wall section 320 may extend and / or substantially flatten (or unfold), and the remaining expansion of the inner bladder 310 may occur in the thick-walled portion 316. Additionally or alternatively, when the inner bladder 310 inflates, the angle between the upper reference line 301 and the upper thin-walled portion 314... It can be increased to approximately 3-20 degrees or 10 degrees, and in one embodiment, the angle between the lower reference line 305 and the lower thin-walled portion 314 The inner sheath 310 can be positioned at the upper part and / or varied to -2 to 30 degrees (negative 2 to 30 degrees) to allow it to extend in a desired downward direction and / or by the desired displacement. In some embodiments, multiple (e.g., 3, 4, 5, 6, or 8) curved wall segments can allow the inner sheath 310 to achieve greater extension and expansion without reaching its elastic deformation limit. It should also be understood that the curved wall segments 320 can be provided only at the upper or lower part of the inner sheath to allow the inner sheath to expand in a desired direction and / or by the desired displacement.

[0229] Figure 11 is a cross-sectional view of a portion of a cervical control system similar to cervical control system 100 or 200, which includes another embodiment of an inner sac 330 coupled to a proximal portion of the wall 332 of the cervical control system. The inner sac 330 includes features similar to those of inner sacs 300 and 310, such as a main inflatable sac or chamber 333, a thin-walled portion 334, and a thick-walled portion 336, and these features function in substantially the same manner as their counterparts in inner sacs 300 and 310. Furthermore, the inner sac 330 also includes a relatively large first curved wall segment 340a located within the upper (as shown in Figure 11) first thin-walled portion 334 and a relatively smaller second curved wall segment 340b located within the lower thin-walled portion 334. As shown in Figure 11, in a neutral, uninflated state, the first curved wall segment 340a and the second curved wall segment 340b of the inner bladder 330 maintain their flexed shape, and when the inner bladder 330 inflates, the curved wall segments 340a and 340b extend and flatten. Since the first curved wall segment 340a is larger than the second curved wall segment 340b, the first curved wall segment 340a can extend to a longer length than the second curved wall segment 340b, thereby allowing the inner bladder 330 to expand radially toward the center of the proximal opening in the desired expansion direction, and also to expand downward away from the transverse plane of the proximal opening (as shown in Figure 11).

[0230] Figures 12 and 13 are cross-sectional views of yet another embodiment of a cervical control system, similar to cervical control system 100 or 200, which includes an inner sac 350 in a neutral or uninflated configuration and an inflated configuration, respectively. The inner sac 350 is coupled to a proximal portion of the wall 352 of the cervical control system. The inner sac 350 includes features similar to those of inner sacs 300 and 310, such as a main inflatable sac or chamber 353, a thin-walled portion 354, a thick-walled portion 356, and a pair of ridges, wedges, or teeth 358 (similar to teeth 318 in Figure 10), each functioning in substantially the same manner as the corresponding features of sacs 300 and 310. The inner sac 350 does not include a curved wall segment but includes a first inflatable sac or chamber 360 and a second inflatable sac or chamber 362. The second inflatable bladder 362 is located between the first inflatable bladder 360 and the main inflatable chamber 353, and the first inflatable bladder 360 is located between the second inflatable bladder 362 and the wall 352. The first inflatable bladder 360 and the second inflatable bladder 362 are adjacent to each other and are arranged substantially coaxially with the main chamber 353. The first inflatable bladder 360 is defined as an elongated trapezoidal cross-sectional shape, having two elongated sidewalls 360a, an upper wall 360b (as shown in Figure 12), and a bottom wall 360c shorter than the upper wall 360b. The second inflatable bladder 362 is defined as an elongated trapezoidal cross-sectional shape, having two elongated sidewalls 362a, an upper wall (as shown in Figure 12) 362b, and a bottom wall 362c shorter than the upper wall 360b. Compared to the inferior walls 360c and 362c, the relatively longer lengths of the superior walls 360b and 362b are used together to orient the inner cuff 350 at an initial downward (orientation in Figure 12) angle θ1 relative to the lower edge of the inner cuff 350 (as indicated by the orientation in Figure 12), represented by the horizontal dashed line 361 superimposed on Figure 12, and may contribute to the downward expansion of the inner cuff 350. The horizontal dashed line 361 may be parallel to the transverse plane of the proximal opening of the cervical control system containing the inner cuff 350.

[0231] When the inner sac 350 inflates, the first sac 360 and the second sac 362 may extend toward the radial center of the proximal opening (represented by the vertically oriented dashed line 363 superimposed on Figures 12 and 13, which is approximately parallel to the radial center of the proximal opening) or may remain substantially unchanged or uninflated. During inflation, the main chamber 353 extends radially inward toward the vertically oriented dashed line 363 (i.e., the axial center of the proximal opening) and downward at an angle θ2 (e.g., 3–50 degrees) relative to the transverse plane of the proximal opening, represented by the horizontally oriented dashed line 361. Referring to the vertical and horizontal dashed lines 363 and 361, the relative radial and downward movement of the inner sac 350 in the neutral and inflated states can be observed. The dashed lines 363 and 361 are in the same position for Figures 12 and 13, thus allowing observation of the relative change in the position and orientation of the inner sac between the inflated and deflated states. In some embodiments, the first bladder 360 and the second bladder 362 and / or the main chamber 353 may be fluidly connected to each other, such that any expansion of the inner bladder 350 simultaneously expands all three chambers. Optionally, the first bladder 360 and the second bladder 362 and / or the main chamber 353 may be individually sealed and fluidly coupled to a dedicated inflation medium conduit, such that the first bladder 360 and the second bladder 362 and / or the main chamber 353 may be individually controlled by the provider (e.g., inflatable or deflated).

[0232] In another embodiment, the inner sac may have a first sac and a second sac, oriented differently than shown in Figures 12 and 13. For example, in some embodiments, the orientation of the second sac 362 may be reversed by 180 degrees, such that the upper wall 362b is located at the lower edge of the inner sac (as shown in the orientation in Figure 12), while the lower wall 362c is located at the upper edge of the inner sac. In such an embodiment, when the first and second sacs of the inner sac are inflated, the two adjacent upper and lower walls of the first and second sacs may extend in a manner similar to a sine wave, which allows for greater ability to make smaller adjustments to the angle θ of the inner sac relative to the horizontally oriented dashed line 361, thereby allowing adjustment of the direction of the pressure applied to the cervix for a better and / or more secure fit. In yet another embodiment, the first sac 360 may have equal upper and lower wall lengths, while the second sac 362 may have inconsistent upper and lower wall lengths (as shown in Figures 12 and 13). In this embodiment, when the first pouch 360 is inflated, the first pouch 360 can expand substantially radially toward the vertically oriented dashed line 363, and the second pouch can expand radially inward toward the vertically oriented dashed line 363 (i.e., the axial center of the proximal opening) and expand downward relative to the horizontally oriented dashed line 361 (i.e., the transverse plane of the proximal opening).

[0233] Figures 14 and 15 provide cross-sectional views of another cervical control system 400 (also referred to herein as "System 400") in a neutral, contracted, and swollen state, respectively. The cervical control system 400 is similar to Systems 100 and 200 described above, but includes some alternative and / or additional components and functions. Similar to the components of Systems 100 and 200, System 400 includes a body 402, a proximal opening 404, a distal opening 406, an internal channel 470, and an inflatable annular inner sac 408. As shown in the cervical control system placement examples of Figures 1 and 2, the inner sac 408 can surround the cervix (e.g., cervix 101) and be placed within the vagina (e.g., vagina 103). Furthermore, as shown, the inner sac 408 includes a first annular sac 410 located above a second annular sac 412 (as oriented in Figure 14) and mechanical engagement elements 414 (e.g., annular ridges, teeth, or wedges) located on the outer surfaces of the first and second annular sacs 410 and 412. Mechanical engagement element 414 may be similar to mechanical engagement element 222. Mechanical engagement element 414, first annular pouch 410 and / or second annular pouch 412 may be integrally formed (e.g., overmolded) in the upper or proximal portion of body 402 and / or integrally formed with the proximal portion of body 402.

[0234] The first annular pouch 410 and / or the second annular pouch 412 may be individually or jointly controllable and / or inflatable, and in some embodiments, may be configured to inflate proximally (e.g., toward uterus 105), radially (e.g., toward internal passage 470), and / or distally (e.g., away from uterus 105). As shown in FIG14, when in a neutral or uninflated state, the first annular pouch 410 and the second annular pouch 412 are recessed away from the first vertical orientation and the second vertical orientation dashed lines 410a and 401b, and as shown in FIG15, when inflated, the first annular pouch 410 and the second annular pouch 412 inflate radially toward the first vertical orientation and the second vertical orientation dashed lines 410a and 401b. In one example, the first annular pouch 410 inflates first, and after the first annular pouch 410 inflates, the second annular pouch 412 inflates, and the inner pouch 408 may expand in a generally proximal direction (e.g., toward uterus 105). In another example, the second annular pouch 412 is inflated first, then the first annular pouch 410 is inflated, and the inner pouch 408 can expand in a generally radially inward direction toward the axial center of the proximal opening 404.

[0235] Having two independently inflatable annular pouches (such as a first annular pouch 410 and a second annular pouch 412) allows for greater flexibility in the expansion, orientation, positioning, and / or engagement of the customized inner pouch 408 with the patient's cervix 101. This allows for adaptation, for example, to the patient's anatomy or vaginal environment (e.g., to accommodate different levels of friction within the vagina 103) without requiring manual adjustment of the system 400's position within the vagina, thereby avoiding the risk of potential irritation and / or the introduction of pathogens into the cervix 101 or vagina 103.

[0236] Figures 16-18 provide exemplary time-series cross-sectional views of how the system 400 is positioned within the patient's vagina 103 (see, for example, Figures 1 and 2), how the cervix 101 is positioned within the internal passage 470 of the system 400, and how the inner sac 408 inflates to engage the cervix 101, thereby controlling, compressing, and / or supporting the cervix 101, for example, by reducing the size of the cervical opening 471. Figures 16-18 include dashed lines 401a and 410b of the first and second vertical orientations, which are in the same positions as shown in Figures 15 and 16, so that comparisons between the figures can be easily observed. In particular, Figure 16 is a cross-sectional view of a portion of the cervix 101 in an expanded state, with the opening 471a of the cervix 101 positioned within the proximal opening 404, such that the lower portion of the cervix 101 (oriented as in Figure 16) is aligned with the lower edge of the inner sac 408. As shown in Figure 17, as the insertion process of system 400 continues, the cervix 101 is further inserted into the internal channel 470. In Figures 16 and 17, the inner sac 408 is in a neutral or uninflated state. When the cervix 101 is in place (e.g., fully inserted into the internal channel 470), the first annular sac 410 and the second annular sac 412 can inflate (as described above with respect to Figure 15) to extend to the first and second vertically oriented dashed lines 401a and 401b, thereby applying a contractile pressure around the cervix 101 to initiate closure and / or reduce the size of the cervical opening to the closed configuration 471b shown in Figure 18. In some cases, the first annular pouch 410 may inflate before the second annular pouch 412, and this initial inflation of the first annular pouch 410 may apply a force to the cervix 101 perpendicular to the transverse plane of the proximal opening 404, or in other words, a force applied to the cervix 101 substantially upward toward the uterus 105. This may be used to push more cervical tissue, thereby pushing the cervical tissue into the proximal opening 404 and down into the internal passage 470 (as shown in Figure 18). Additionally or alternatively, when the first annular pouch 410 and the second annular pouch 412 are inflated as shown in Figure 18, the mechanical engagement element 414 may invade and engage the exterior of the cervix 101, thereby holding the system 400 in place.

[0237] In some embodiments, the cervical control system may include an external inflatable positioning balloon configured to expand into and / or engage with the vaginal wall when inflated and in situ. These external inflatable positioning balloons may facilitate, for example, orientation of the cervical control system within the vagina to properly and / or optimally accept insertion and / or engage with the cervix, and / or maintain the cervical control system in a proper position around the cervix within the vagina.

[0238] Figures 19 and 20 provide cross-sectional views of another exemplary cervical control system 500, which has an inflatable annular inner cuff 508 (also referred to herein as "inner cuff 508"), the inner cuff 508 including components and functions similar to those of systems 100, 200, and 400 described above. System 500 includes a body 502, a proximal opening 504, a distal opening 506, and an internal channel 570. Furthermore, the inner cuff 508 of system 500 includes a recessed portion 510, an inflatable portion 512, and a first inflation medium conduit 516a, configured to be in fluid communication with the inner cuff 508 via a port 520, as described herein. Port 520 is also in fluid communication with an external distal cuff 518 (also referred to herein as "positioning balloon 518") via a second inflation medium conduit 516b. The recessed portion 510 may be similar to the recessed portion 110, while the inflatable portion 512 may be similar to the inflatable portion 112 (see, for example, Figures 3 and 4). The positioning balloon 518 is sized, positioned, and / or constructed to inflate into and engage the wall of the vagina 103 to hold the system 500 in a desired position and / or orientation around the cervix 101 and / or the vagina 103. In one embodiment, the positioning balloon 518 may include structures and functions similar to those of the inner balloons 108, 208, 300, 310, 330, 350, and / or 408 described above, such as curved wall segments 320, 304a, or 340b (Figures 10 and 11), non-uniform wall thickness as shown in the inner balloons 300, 310, 330, and 350 (Figures 9–13), and / or two or more balloons as shown in the inner balloon 350 (Figures 12 and 13) and the inner balloon 408 (Figures 14–18). During inflation, the positioning balloon 518 expands outward, away from the axial center of the distal opening 506, and thus toward the vaginal wall 103. The outward expansion of the positioning balloon 518 is shown in successive Figures 19 and 20, with dashed lines added to more clearly show the relative movement of the positioning balloon 518 in the inflated state shown in Figure 20 relative to the neutral state shown in Figure 19.

[0239] Figures 21 and 22 illustrate an embodiment of an inflatable cuff system or portion of a cervical control system 600, coupled to the distal portion and / or the exterior of the wall 602 of the cervical control system (e.g., systems 100, 200, 400, or 500 described above). The inner cuff system 600 includes a pair of inflatable annular pouches or chambers, comprising a first or radial pouch 604 and a second or transverse pouch 606. The radial pouch 604 is positioned peripherally around the distal portion of the body 602, and the transverse pouch is positioned along the distal end of the body 602. Upon inflation, the radial pouch 604 expands outwards away from the axial center of the distal opening 608 of the system 600 to extend into the vaginal wall in situ. Upon inflation, the transverse pouch 606 expands downwards away from the distal end of the body 602. In other words, the transverse pouch 606 expands in the direction opposite to the uterus 105. A dashed line is provided between consecutive Figures 21 and 22 to more clearly illustrate the relative expansion of the transverse pouch 606 from the neutral state in Figure 21 to the inflated state in Figure 22. In the inflated state, the transverse pouch 606 increases the overall length of the system 600, which allows the provider to adapt to the patient's anatomy and / or further engage the cervix 101 and / or provide additional control and / or support to the cervix 101 and / or uterus 105 via an inner pouch (similar to the inner pouch disclosed herein) located at the upper or proximal end of the wall 602.

[0240] In some embodiments, either or both of the radial pouch 604 or the transverse pouch 606 may include structures and functions similar to those of the aforementioned pouches 108, 208, 300, 310, 330, 350, 408, 508, and / or 518, such as curved wall segments 320, 304a, or 340b (Figures 10 and 11), non-uniform wall thicknesses as shown in the inner pouches 300, 310, 330, and 350 (Figures 9-13), and / or two or more smaller pouches as shown in the inner pouches 350 and 408 (Figures 12-13 and 14-18, respectively). Although the pouch system 600 is illustrated as having two pouches 604 and 606, in one embodiment, a single pouch or cavity may provide sufficient vaginal wall engagement while also increasing the overall length of the system 600. For example, expansion elements may be provided along specific walls of a single pouch to provide desired directional expansion. It is conceivable that system 600 (and any of the foregoing or subsequent embodiments of the cervical control system) can be placed in the patient's body in an inverted manner, with the distal end facing and engaging the cervix 101 to support the cervix and uterus 105. In this inverted orientation, the positioning balloon of the cervical control device can be positioned to contact the upper vaginal wall and fornix region (e.g., the upper part of the vagina, extending into the recess formed between the vaginal wall and the lower part of the cervix), such that when the positioning balloon inflates, it can provide support for the uterus 105 at the location where prolapse would typically occur. In embodiments where the positioning balloon inflates in the lateral direction, the positioning balloon will distribute the load of the uterus 105 along the vaginal wall to a larger surface area (relative to a cervical control system with the inner balloon oriented towards the uterus in a standard orientation), which can reduce the risk of medical complications (e.g., the risk of pressure sores and / or necrosis). In embodiments where the positioning balloon expands in both the lateral direction and in directions away from the body (e.g., toward the uterus 105), the positioning balloon can provide upward support to the uterus (which can be customized as needed) while distributing the load of the uterus 105 to a larger surface area.

[0241] Figures 23 and 24 provide a top perspective view and a bottom perspective view, respectively, of another embodiment of a cervical control system 700, which includes a body similar to or substantially the same as the cervical control system 100 described herein and shown in Figures 1-6. Similar to system 100, system 700 includes a body 702, a proximal opening 704, a distal opening 706, an inner sheath 708, a recess 710, an expandable portion 712, an inflation medium conduit 716, and an inlet 720, which can be configured and / or functionalized in a manner corresponding, for example, to the body 102, the proximal opening 104, the distal opening 106, the inner sheath 108, the recess 110, the expandable portion 112, the inflation medium conduit 116, and the inlet 120. Furthermore, system 700 includes internal and external release notches 722a and 722b, respectively, located on the internal and external surfaces of the body 702. The internal and external release notches 722a and 722b extend substantially between the distal end of the body 702 and the inner sheath 708, and can be configured to expand and / or provide increased flexibility to the body 702, thereby facilitating the contraction or folding of the system 700 before insertion into and / or withdrawal from the patient's vagina. For example, the provider may be able to fold the cervical control system such that it forms a leading edge or tip with a reduced cross-sectional area for easier insertion through the vaginal opening. In addition to facilitating insertion, the notches 722a and 722b may also provide visual indication of which side is intended for initial insertion into the patient.

[0242] Figures 25-34 provide various views of another exemplary cervical control system 800 (also referred to herein as "System 800"), which may have some features, components, and / or functions of one or more cervical control systems and / or cervical control system components disclosed herein. Specifically, Figure 25 provides a perspective view of System 800 in a neutral state; Figure 26 provides an exploded view of System 800; Figure 27 provides an anatomical view of System 800; Figure 28 provides a top perspective view of System 800 in an inflated state; Figure 29 is a cross-sectional view of System 800 with the inner sheath 808 and positioning balloon 818 in a neutral, uninflated state; and Figure 30 is a sectional view of System 800 with the inner sheath 808 in an inflated or swollen state. The positioning balloon 818 is in a neutral, uninflated state; Figure 31 is a cross-sectional view of the system 800, in which the inner balloon 808 and the positioning balloon 818 are inflated or inflated; Figure 32A is a cross-sectional view of the system 800 coupled to the inflation medium source; Figure 32B is a detailed view of a portion of Figure 32A; Figure 32C is a close-up view of a portion of the inflation medium source; Figure 33 is a sagittal view of the pregnant woman inserted into the system 800 in its original position; Figure 34 is a close-up view of a portion of the system 800.

[0243] System 800 includes a body 802, a proximal opening 804, a distal opening 806, an internal channel 870, an inflatable annular inner bladder 808 (also referred to herein as "inner bladder 808") located near the proximal opening 804, and an inflation medium conduit 816 (Figures 29 and 30). The inner bladder 808 includes three recessed portions 810 and three inflatable portions 812, which are evenly distributed around the proximal portion of the body 802 and define the proximal opening 804, as can be most clearly seen in Figure 28.

[0244] System 800 also includes an externally inflatable annular cuff or cuff system 818 (also referred to herein as “positioning balloon 818”) positioned near the distal opening 806. Positioning balloon 818 is configurable and / or operable to expand distally away from the distal end of body 802 and away from uterus 105 upon in situ inflation. Positioning balloon 818 may include one or more inflatable pouches or pouch segments. In the embodiments of Figures 25-33, positioning balloon 818 includes three inflatable pouch segments 818a arranged circumferentially and evenly spaced around the distal end of body 802 (e.g., see Figure 26), but this arrangement is not mandatory. For example, positioning balloon 818 may include more (e.g., 4-8) or fewer (e.g., 2) inflatable pouch segments, or positioning balloon 818 may be formed from a single, continuous, uninterrupted pouch. Figure 29 depicts system 800 with both the inner cuff 808 and the positioning balloon 818 in a neutral or uninflated state; Figure 30 depicts system 800 with the inner cuff 808 in an inflated or inflated state and the positioning balloon 818 in a neutral or uninflated state; and Figure 31 depicts system 800 with both the inner cuff 808 and the positioning balloon 818 in an inflated or inflated state. Each inflatable pouch segment 818a can be selectively and / or individually inflated, and an example of selective inflation of pouches 818a is shown in Figure 33, where one pouch 818a of the positioning balloon 818 (positioned towards the posterior aspect of the patient) is inflated to a greater extent than the other two pouches 818a.

[0245] During inflation, the inner bulb 808 expands substantially inward toward the axial center of the proximal opening 804, as shown in Figures 30 and 31, with dashed lines added to more clearly show the relative expansion of the inner bulb 808 as it transitions from a neutral state (Figure 29) to the inflated state shown in Figure 30. During inflation, the positioning bulb 818 and / or the inflatable segment 818a expand inward toward the axial center of the distal opening 806 and outward away from the axial center of the distal opening 806, and thus expand toward the vagina in situ, as sequentially illustrated in Figures 30 and 31, with dashed lines added to more clearly show the dimensional changes relative to its neutral state as shown in Figure 30 when in the inflated state shown in Figure 31.

[0246] For example, as shown in Figures 26, 27, and 29-32, system 800 includes a lumen ring 822 located between the distal end of body 802 and positioning balloon 818. The lumen ring 822 includes a plurality of channels 824 leading to a pouch segment 818a, an inflation medium conduit 816, and an inlet 820, and is configured to provide fluid communication between the pouch segment 818a, the inflation medium conduit 816, and the inlet 820. When system 800 is fully assembled with the lumen ring 822 positioned between body 802 and positioning balloon 808, the channels 824 form a plurality of closed cavities (e.g., as shown in Figures 29-32), with the distal end of body 802 forming the top of the closed cavity. Each of the multiple channels can be fluidly connected to the open port 827 of the inlet 820 (see Figure 32B) and the inflatable segment 818a of the positioning balloon 810, such that in some embodiments, each individual inflatable balloon 818a can lead to a single cavity, the other end of which leads to a single port 827, and in this way, the inflation and deflation of each inflatable balloon segment 818a can be individually controlled by injecting and / or withdrawing fluid from the cavity and / or port 827.

[0247] Inlet 820 can be configured to work in conjunction with multi-chamber expandable medium delivery device 801, examples of which are shown in Figures 32A-32C. Multi-chamber expandable medium delivery device 801 includes a multi-chamber tube 828 and an end cap 829, the end cap 829 including four one-way valves 830 (e.g., check valves, one-way duckbill valves, etc.) extending therefrom. The size, construction, and position of the one-way valve 830 can be set on the end cap so that the one-way valve 830 can be inserted into the corresponding port 827 of the inlet 820 for delivering the inflation medium to the channel 824, the inflatable sac segment 818a, the inner sac 808, and / or the positioning balloon 818, and / or extracting the inflation medium from the channel 824, the inflatable sac segment 818a, the inner sac 808, and / or the positioning balloon 818. This allows for individual control of the inflation / contraction of each inflatable sac segment 818a, the inner sac 808, and / or the positioning balloon 818, inflating and / or constricting these components as needed. This allows the system 800 to be properly fitted and fixed within the patient's vagina 103 and around the cervix 101, thereby achieving control of the cervix 101. The ability to manage each of the pockets 808 and 818a allows the care provider to redirect or reposition the cervix 101 in a specific manner to, for example, close the cervix 101, maintain cervical closure, relieve pressure on the cervix, and / or stabilize the cervix 101. For example, the provider can alter the orientation of the system 800 by selectively inflating one or more positioning balloons 818a. For instance, in Figure 33, the pocket segment 818a located posterior to the patient is inflated to a greater degree than the pocket segment 818a located anterior to the patient, such that, for example, the system 800 can be pushed anteriorly towards the patient.

[0248] It is conceivable that the lumen within tube 828 could serve as a channel for delivering items to system 800. For example, nickel-titanium alloy wire, springs, electrical wires, or medications / agents could be delivered to system 800 via tube 828. Tube 828 could be detachably coupled to system 800, thereby facilitating patient movement, or tube 828 could be permanently integrated into the cervical delivery system, with the tube remaining inside the patient and / or extending to the outside of vagina 103.

[0249] In some embodiments, the inner sheath 808 includes a variable wall thickness, having upper and lower thin-walled portions 832 and a thicker or thicker-walled portion 834 at the proximal portion of the inner sheath 808 between the upper and lower thin-walled portions 832, which can be most clearly seen in FIG. 34. In these embodiments, the inner sheath 808 is coupled to the proximal end of the body 802 by teeth 836, which engage with recesses 838 formed at the proximal end of the body 802. The thin-walled portions 832 and the thick-walled portions 834 function similarly to portions 304 and 306 of the inner sheath 300 shown in FIG. 9 and described above.

[0250] Figure 35 provides a top view of another exemplary cervical control system 900, similar to the systems 100, 200, 400, 500, 700, and 900 described above, but with an asymmetrical and non-circular or non-spherical body 902. Similar to systems 100, 200, 400, 500, 700, and 800, system 900 includes a body 902, a proximal opening 904, a distal opening (not shown), an inflatable annular inner sac 908 located near the proximal opening 904, and an inflatable annular positioning balloon 918 located near the distal opening, with two or more inflatable sac segments 918a defining the positioning balloon 918. The asymmetrical shape of the body 902 can, for example, limit or prevent rotation of system 900 within vagina 103 by occupying space in a correspondingly asymmetrically shaped vagina 103 near cervix 101, thereby providing improved engagement with vagina 103.

[0251] Figures 36 and 37 provide a top perspective view and a cross-sectional view of another cervical control system 1000, respectively. System 1000 is similar to systems 100 and 200 described above and shown in Figures 1-6 and 7-8, respectively, and includes a body 1002, a proximal opening 1004, a distal opening 1006, an inflatable annular sheath 1008 having a recessed portion 1010 and an inflatable portion 1012, an internal channel 1070, and a pair of protruding annular segments 1014. Furthermore, the cervical control system 1000 includes a series of mechanical engagement mechanisms 1016 in the form of, for example, ridges, wedges, and / or teeth (collectively referred to herein as “wedges”), which may resemble wedges 222 located on the outer surface of the inflatable portion 1012. Wedges 222 may be arranged in rows, columns, staggered rows, and / or staggered columns along a portion of the inner surface of the inflatable portion 1012 of the inner sheath 1008. The wedge 1016 may be configured to grip the exterior of the cervix 101 when the system 1000 is in situ, to enhance the engagement of the system 1000 with the cervix when positioned within the internal channel 1070, and / or to provide additional gripping force to hold the cervix 1000 in an elongated and closed state, and to mitigate or prevent accidental movement between the system 1000 and the cervix 101 (e.g., preventing the cervix 101 from slipping out of the inner sheath 1008). The wedge 1016 may be formed together with the outer wall of the inner sheath 1008 and / or the expandable portion 1012 by processes such as extrusion, molding, and / or overmolding. It is conceivable that the wall thickness of the inner sheath 1008 at or near each wedge 1016 can vary to allow the wedge 1016 to extend outward relative to the inner sheath 1008, such that when the inner sheath 1008 is in an inflated state, the wedge 1016 protrudes more from the outer surface of the inner sheath wall compared to when the inner sheath 1008 is in a neutral state. As shown, the size and position of the annular edge segment 1014 can be configured to extend from the portion of the body 1002 corresponding to and / or near the inflatable portion 1012, rather than from the portion of the body 1002 corresponding to and / or near the recessed portion 1010. In this way, the size and position of the annular edge segment 1014 can be configured such that the annular edge segment 1014 does not correspond to the location of blood vessels within the cervix located within the internal passage 1070, thus avoiding compression of these blood vessels or inhibition of blood flow through them.

[0252] Figures 38-42 show radial cross-sectional views of various exemplary wedges 1016a-1016e. For reference purposes, figures 38-42 also show dashed arrows next to each radial wedge profile 1016a-1016e to indicate the direction of the distal side of the cervical control system in which the corresponding wedge 1016 may reside. In some embodiments, the height of the wedge 1016 (e.g., the distance by which the wedge 1016 extends above the inner sheath wall) can range, for example, from about 100 micrometers (100 μm) to 1500 micrometers (1500 μm). The length of the exemplary wedge 1016 (e.g., the distance between the top and bottom edges of the wedge 1016 (as shown in Figures 38-42)) can range from about 100 micrometers (100 μm) to 1500 micrometers (1500 μm). In some embodiments, the various wedge profiles 1016a-1016e of Figures 38-42 may be molded or formed from the same material as the inner sheath 1008, or the wedges may be formed from different materials or materials of different hardness (e.g., silicone or plastic that is more rigid than the silicone of the inner sheath 1008) and subsequently fixed to the inner sheath 1008 by any suitable means (e.g., chemical and / or thermal bonding). For manufacturing purposes, it is more preferable that the wedge 1016 is formed from the same elastic material as the inner sheath 1008. The wedge 1016 may be individually configured to function as a suction cup (see, for example, wedge 1016a of Figure 38) to form a vacuum engagement with tissue outside the cervix 101, and / or to function as a protrusion configured to extend into and engage the outside of the cervix 101. As shown in Figures 38-42, wedge profiles 1016a, 1016b, 1016c, 1016d, and 1016e are shown as solid bodies. However, in one embodiment, the wedge 1016 may have a gap between its periphery and the inner sheath wall, or the wedge 1016 may have a gap leading to the inner sheath 1008, such that when the inner sheath inflates, the gap in the wedge 1016 can inflate or expand to expand the size and / or shape of the corresponding wedge 1016. As shown in FIG39, the wedge 1016b has an extension with a curved lower profile configured to extend into and hook cervical tissue; as shown in FIG41, the wedge 1016c has a rectangular profile protrusion; as shown in FIG42, the wedge 1016d has a truncated trapezoidal profile protrusion; as shown in FIG42, the wedge 1016e may be configured such that the downward edge / tip 1017 forms an acute angle with the outer wall of the inner sheath 1008. This configuration can effectively act as a hook to grasp and fix cervical tissue, thereby providing improved engagement with cervical tissue.

[0253] Figures 43-50 show front view shapes of various wedges 1016f-1016m. For reference purposes, figures 43-50 also show dashed arrows next to each wedge 1016f-1016m to indicate the direction of the distal side of the cervical control system in which the corresponding wedge 1016f-1016m can reside. Any wedge shape 1016f-1016m (and other suitable wedge shapes) can be used in combination with any wedge profile 1016a-1016e (and other suitable wedge profiles) to form the desired wedge 1016 for inclusion in the cervical control system and / or inner sheath (e.g., the cervical control device and / or inner sheath disclosed herein) and / or for engagement with the cervix 101. The wedge shape 1016f shown in Figure 43 is circular and may have a diameter, for example, ranging from about 50 micrometers (50 μm) to 2000 micrometers (2000 μm). Figures 44-49 illustrate non-circular wedge shapes 1016g-1016l, which may have total height and width dimensions, for example, ranging from 25 micrometers (25 μm) to 2500 micrometers (2500 μm). Specifically, Figure 44 shows a rectangular wedge 1016g, Figure 45 shows a trapezoidal wedge 1016h, Figure 44 shows an inverted trapezoidal wedge 1016i, Figure 47 shows a truncated triangular wedge 1016j, and Figure 48 shows an inverted truncated triangular wedge 1016k. Figures 49 and 50 show additional geometric wedge shapes 1016l and 1016m, each extending outward from the inner sheath wall 1008 to a tip or apex 1019 and 1021, respectively. The wedge shape 1016l in Figure 49 is typically pyramidal in shape and, in the illustrated embodiment, is an inclined pyramid with its tip 1019 offset downwards. The wedge shape 1016m is typically conical, and in the illustrated embodiment, it is an inclined cone with its tip 1019 offset toward its lower side.

[0254] Figures 51-54 provide various views of another cervical control system 1100 (also referred to herein as "System 1100"). Specifically, Figure 51 provides a top perspective view of System 1100; Figure 52 provides a cross-sectional view of System 1100 when the positioning balloon 1118 is in a neutral state; Figure 53 provides a cross-sectional view of System 1100 when the positioning balloon 1118 is inflated; and Figure 54 provides a cross-sectional view of System 1100 when the positioning balloon 1118 is inflated and System 1100 is coupled to and / or integrated into an inflation medium source. Similar to the components of systems 100, 500, and 1000 described above and shown in Figures 1-6, 19-20, and 36-37 respectively, system 1100 includes a body 1102, a proximal opening 1104, a distal opening 1106, an inflatable annular inner bladder 1108 (also referred to herein as “inner bladder 1108”) having a recessed portion 1110 and an inflatable portion 1112, an internal channel 1170, and a raised annular rim 1114. Further similar to the components of system 500, system 1100 includes an external or distal inflatable annular bladder 1118 (also referred to herein as “positioning balloon 1118”) located near the distal opening 1106 outside the body 1102. Further similar to the components of system 1000, system 1100 includes an array of wedges or teeth 1116 arranged on and extending from the outer surface of an inflatable portion 1112 surrounding an inner sheath 1108. The wedges 1116 may be similar in shape and / or function to the wedge 1016 shown in Figures 38-50 and discussed herein. Compared to system 500, the positioning balloon 1118 of the cervical control system 1100 is relatively larger than the positioning balloon 518, and the positioning balloon 1118 extends upward along the wall of the body 1102 of system 1100 to a greater extent than the positioning balloon 518 extends upward along the body 502.

[0255] In various embodiments, the positioning balloon 1118 may extend to half the outer wall of the body 1102, or to substantially the entire length of the outer wall of the body 1102. The increased size of the positioning balloon 1118 increases the contact area between the positioning balloon 1118 and the patient's vagina 103, to provide, for example, greater stability of the system 1100 in situ, and improved support and / or control of the patient's cervix 101 and / or uterus 105. The positioning balloon 1108 may comprise a single pouch or multiple pouches (e.g., 2-8), such as pouch 818a of the positioning balloon 818 described above and shown in Figures 25-31.

[0256] Furthermore, compared to system 1000, the wedge 1116 of the cervical control system 1100 is significantly larger than the wedge 1016 of system 1000, and the number of wedges 1116 disposed around the inner periphery of the expandable portion 1112 is less. Like wedge 1016, wedge 1116 can be configured to engage (e.g., press in and / or adhere) cervical tissue after the cervix 101 is inserted into the internal channel 1170 and the expandable inner sheath 1108 and / or the expandable portion 1112, in an attempt to provide additional gripping force to pull and / or hold the cervix 101 in an extended and closed state (see, for example, FIG. 18), and to alleviate or prevent the cervix 101 from slipping out of the inner sheath 1108. Wedge 1116 can be integrally formed with the outer wall of the inner sheath 1108 (e.g., by extrusion, molding, or overmolding processes). In some cases, the wall thickness of the inner bladder 1108 at or near each wedge 1116 can vary to, for example, allow the wedge 1116 to extend outward relative to the inner bladder 1108, such that when the inflatable portion 1112 is in an inflated state, the wedge 1116 is located closer to the outer surface of the inflatable portion 1112 than when the inflatable portion 1112 is in a neutral state.

[0257] Similar to the arrangement of the teeth 836 of the inner sheath 808 of the system 800 as described above and shown in Figures 25-31, and the recesses 838 within the wall of the body 802 of the system 800, the inner sheath 1108 is coupled to the proximal end of the wall of the body 1102 via teeth 1136, which are fitted onto the proximal end of the body 1102 and fit into or engage with the recesses 1138 located on the top and bottom sides (oriented as shown in Figure 52) of the proximal end. As shown in Figures 52-54, the body 1102 also has a distally positioned recess 1142 and a centrally positioned recess 1142 located on the outer surface of the body 1102, both sized, constructed, and positioned to receive the distal and proximal teeth 1140 of the positioning balloon 1118, thereby allowing the positioning balloon 1118 to be coupled to the body 1102. Teeth 1136 and / or 1140 can be secured within recesses 1138 and / or 1142 by any acceptable means (including but not limited to chemical, mechanical, thermal and vibrational bonding).

[0258] As shown in Figure 54, system 1100 includes a first inflation medium conduit 1144 and a second inflation medium conduit 1146, both of which are in fluid communication with the inner cuff 1108 and the positioning balloon 1118, respectively. The inflation medium conduits 1144 and 1146 are structurally and functionally similar to the inflation medium conduits 116, 216, 516, and 816 of the corresponding systems 100, 200, 500, and 800 (see, for example, Figures 5 and 6, 7 and 8, 19 and 20, and 29 and 30, respectively). As shown in Figure 54, the inflation medium conduits 1144 and 1146 are dedicated to the corresponding cuffs 1108 and 1118, respectively, and extend within the body 1102 such that their first end opens inward toward the cuff 1108 and the positioning balloon 1118, and their second end extends away from the body 1102 and resides within the tube 1148 (e.g., a multi-lumen conduit) until the distal end of the tube 1148 terminates at the valve system 1150, which is functionally similar to the valve system 826 described above and shown in Figures 29-30.

[0259] Valve system 1150 includes a first valve 1152 communicating with a first catheter 1144 and a second valve 1154 communicating with a second catheter 1146. The first valve 1152 and / or the second valve 1154 may be, for example, a one-way valve and / or a one-way duckbill valve. Tube 1148 may be configured to be of sufficient length to extend from system 1100 to the patient's cervix 101, through the vagina 103, and from the vaginal opening sufficiently (e.g., 2-24 inches) to allow clinicians access to and utilization of valve system 1150 to inject inflation media into inner cuff 1108 and / or positioning balloon 1118, and / or extract inflation media from inner cuff 1108 and / or positioning balloon 1118 without requiring, for example, removal or repositioning of system 1100 from cervix 101 and / or vagina 103. Making the first valve 1152 and / or the second valve 1154 accessible externally to the vagina allows for easy access to and / or use of the first valve 1152 and / or the second valve 1154 without requiring repositioning of the respective first catheter and / or second catheter and / or cervical control system 1000 during use. Additionally or alternatively, positioning the first valve 1152 and / or the second valve 1154 such that they are externally located during use allows the care provider to easily break the pressure seal, thereby releasing pressure within catheters 1144 and 1146 and cuffs 1108 and 1118 (pressure that would otherwise be trapped due to the function of the one-way valves 1152 and 1154). For example, known or commercially available devices (e.g., locking needles or syringe connectors coupled to tube 1148) can be used to allow the care provider to easily break the pressure seal. The care provider can break the pressure seal by removing the valve system 1150 from tube 1148.

[0260] Figures 55-57 provide various views of another cervical control system 1200 (also referred to herein as "System 1200"), wherein Figure 55 is a bottom perspective view, Figure 56 is a cross-sectional bottom perspective view of System 1200 with the distal edge removed to show the dimensions, shape, and location of the fluid reservoir 1240, and Figure 57 is a cross-sectional view of System 1200. System 1200 includes some components similar to System 1100 and other cervical control systems disclosed herein. For example, system 1200 includes a body 1202, a proximal opening 1204, a distal opening 1206, an internal channel 1270, an inflatable annular inner sac 1208 (also referred to herein as "inner sac 1208") including a recessed portion 1210 and an inflatable portion 1212, an array of wedges or teeth 1216 disposed and positioned on the outer surface of the inflatable portion 1212 of the inner sac 1208, and teeth 1236, as shown in FIG. 57, the teeth 1236 being sized, structured, and positioned to mate and engage recesses 1238 formed on the top and bottom (as shown in FIG. 57) of the proximal end of body 1201. Furthermore, system 1200 includes an optional distal external inflatable element 1255 configured to receive an inflation medium and expand outward to the vaginal wall when system 1200 is in situ.

[0261] System 1200 also includes a fluid reservoir 1240 (Figures 56 and 57) located within the wall of body 1202 and in fluid communication with an inner bladder 1208 and a valve system (not shown) having an inlet 1241 (Figure 55). Inlet 1241 may be, for example, a check valve (as described previously for systems 800 and 1100) and / or a duckbill valve configured to transfer the inflation medium from fluid reservoir 1240 to inner bladder 1208 and / or allow air passage, thereby achieving equilibrium within fluid reservoir 1240 (e.g., avoiding a vacuum). System 1200 also includes a component cavity 1242 located within another portion of the wall of body 1202, adjacent to fluid reservoir 1240 (Figure 56). The component cavity 1242 is sized and configured to provide space for accommodating an internal fluid pump 1244, which is located within the wall of the body 1202 and is in fluid communication with a fluid reservoir 1240 via a first conduit 1246 and with an inner bladder 1208 via a second conduit 1248 (FIG. 57). The pump 1244 may be configured and / or operable to deliver fluid from the fluid reservoir 1240 to one or more portions of the inner bladder 1208 to inflate and / or deflate the inner bladder 1208. In some embodiments, the inlet 1241 may be a vent configured to allow air to be introduced to counteract a vacuum created during operation of the pump 1244.

[0262] A controller or computer 1250 is electronically coupled to the pump 1244 and can be configured to execute one or more instructions to control the operation of the pump 1244 (e.g., on / off, flow rate, etc.). A power source (in the form of a rechargeable battery 1252) is coupled to the pump 1244 and the controller 1250. The controller 1250 may support wireless communication / control, allowing a care provider to remotely inflate / contract the inner sac 1208 without any invasive procedures to access the system 1200, thus making the cervical control system 1200 a closed system that does not require external or external physical intervention to regulate the cervical control system. For example, the controller 1250 may include Bluetooth® wireless communication or other remote control devices. A charging cable may be provided for charging the power source, for charging the battery 1252 inside or outside the patient. Optionally, a pressure sensor 1254 may be coupled to the controller 1250 to measure the pressure applied to the system 1200 and provide these measurements directly or indirectly to, for example, a display device (such as a computer screen). Information provided by pressure sensor 1254 can be used to determine, for example, the state of system 1200, the inflation / contraction state of inner sac 1208, and / or the pressure applied to cervix 101 or vagina 103. In some embodiments, pressure sensor 1254 may be adapted to detect pressure drops within an acceptable range (e.g., set by the care provider), and pump 1244 may be configured to automatically add fluid to inner sac 1208 in a pressure drop to maintain a desired level of inflation. In alternative embodiments, position and / or orientation sensing devices (e.g., solid-state gyroscope modules) may be provided to detect orientation data of cervical control system 1200 (e.g., solid-state gyroscope modules may detect and / or determine the orientation angle of system 1800 relative to the gravity vector). Based on the position data, the device may be adapted to automatically adjust the angle of cervical control system if the cervical control system moves beyond a desired position (a desired position set by the care provider). Any apparatus, system, and / or method described herein may include one or more features disclosed in U.S. Patent Application 17 / 813,454 (filed July 19, 2022), International Patent Application PCT / IB2022 / 056650 (filed July 19, 2022), U.S. Provisional Application 63 / 237,708 (filed August 27, 2021), or U.S. Provisional Application 63 / 300,263 (filed January 18, 2022), the entire contents of which are incorporated herein by reference.

[0263] Figures 58 and 59 illustrate an embodiment of system 1301, which includes a cervical control system 1300 (also referred to herein as "system 1300") and an inflation system 1302, wherein Figure 58 is a perspective view of system 1301 and Figure 59 is an exploded perspective view of system 1301. System 1300 has some features and functions similar to those of systems 100, 500, 1000, and 1100 described above and shown in Figures 1-6, 19-20, 36-37, and 51-54, such as a body 1302, a proximal opening 1304, a distal opening 1306, an internal channel 1370, and an inflatable annular inner sheath 1308 having a recessed portion 1310 and an inflatable portion 1312. Further similar to the components of system 1100, system 1300 includes a positioning balloon 1318 positioned on the outer surface of body 1302, near distal opening 1306. Further similar to the components of system 1100, system 1300 includes an array of wedges or teeth 1316 extending from the outer surface of inflatable portion 1312 into internal channel 1370. In some embodiments, system 1300 may not include wedges 1316.

[0264] The positioning balloon 1318 is configured to inflate once the system 1300 is positioned within the patient's body, expanding and entering the vaginal wall from its axial center away from the distal opening. Similar to system 1100, the positioning balloon 1318 of the cervical control system 1300 extends more than the positioning balloon 518 of system 500 on the wall of the body 1302 of system 1300; however, unlike system 1100, the positioning balloon 1318 of the cervical control system 1300 does not surround the entire circumferential extension of the body 1302. Instead, as shown in Figure 58, the positioning balloon 1318 extends only around a portion (e.g., 20-90%) of the circumference of the body 1302. When in a contracted state, the positioning balloon 1318 may be flush with or extend away from the outer surface of the body 1302 (e.g., internal channel 1370) by approximately 0.1-3 mm. When inflated, the positioning balloon 1318 can extend away from the outer surface of the body 1302 (e.g., the internal channel 1370) by approximately 0.5-12 mm, 6.25 mm, 4-7 mm, 7 mm, 4-6 mm, and any value between the above.

[0265] Arranging the positioning balloon 1318 to surround only a portion of the circumference of the main body 1302 allows for more precise positioning of the cervical control system within the patient's anatomy, thereby avoiding pressure and / or force applied, for example, in a posterior direction. This can increase patient comfort and / or reduce the likelihood of the inflated positioning balloon 1318 compressing the rectum, which can lead to discomfort, constipation, and / or bowel complications. For example, the arcuate structure of the positioning balloon 1318 means that it does not inflate uniformly distal to the system 1300 (unlike the uniform inflation of a ring-shaped positioning balloon that extends circumferentially around the main body of the cervical control system). Therefore, pressure may not be uniformly applied to the vaginal extension in all directions, thus avoiding pressure on organs and tissues near the vagina (e.g., the bladder, rectum, etc.) that could be damaged or irritated by the pressure applied thereto. This can make the system 1300 more comfortable for the patient to wear, especially over extended periods (e.g., days or weeks). In some cases, the inflation of the positioning balloon 1318 can adjust the positioning and / or orientation of the cervix to a posterior or anterior position. For example, the inflation and / or expansion of the positioning balloon 1318 can cause translation (e.g., forward movement) of the system 1300, and due to the high position of the system 1300 on the cervix, where the positioning balloon 1318 is positioned close to and / or against the patient's fornix, this translation can result in posterior tilting of the cervix. In some cases, the cervical control system does not have a positioning balloon and only uses an inner sheath. In some embodiments, the cervical control system does not include an inner sheath and only uses a positioning balloon. In these embodiments, the system 1300 may not apply pressure to the cervix, but can tilt the cervix to a preferred angle.

[0266] Inflation system 1351 includes a first inflation medium conduit 1344 and a second inflation medium conduit 1346 located within a tube 1348 (which may be a multi-lumen tube including a first conduit 1344 and a second conduit 1346). System 1300 may include a first inlet (not shown) in fluid communication with an inner cuff 1308 and a second inlet (not shown) in fluid communication with a positioning balloon 1318, and a first end of tube 1348 may be physically coupled to system 1300 through the first inlet and / or the second inlet. Additionally or alternatively, as shown in FIG59, the first inflation medium conduit 1344 may extend away from the second inflation medium conduit 1346 for insertion into the first inlet, thereby allowing the first inflation medium conduit 1344 to be in fluid communication with the inner cuff 1308, as shown in FIG58. Additionally or alternatively, as shown in FIG58, the second inflatable medium conduit 1346 may be configured to be inserted into the second inlet, thereby enabling the second inflatable medium conduit 1346 to be in fluid communication with the positioning balloon 1318. In some cases, system 1301 may include more or fewer than two inflatable medium conduits. For example, system 1301 may include one, three, four or more inflatable medium conduits.

[0267] The length of tube 1348 (e.g., 3-24 inches) is sufficient to extend away from system 1300 (when placed in the patient's vagina) and protrude through the vaginal opening, allowing the care provider easy access to valve system 1350 without removing or repositioning system 1300 from the patient. A second distal end of tube 1348 and / or a second end of first inflation medium catheter 1344 and / or second inflation medium catheter 1346 may be coupled to valve system 1350, which includes valve housing 1360 (see Figures 60-61C and their related discussion below for further details). Valve housing 1360 has a proximal end 1362 and a distal end 1364 and may be coupled to the distal ends of first catheter 1344 and second catheter 1346 within tube 1348. The distal end 1364 of the valve housing 1360 can secure the first valve 1352 and the second valve 1354, and may include a first opening 1366a and a second opening 1366b (as shown in FIG. 59). Through the first opening 1366a and the second opening 1366b, the distal ends of the corresponding first valve 1352 and the second valve 1354 can be accessed and / or coupled to a syringe, pump, or other inflation device (which can supply inflation medium to inflate the internal balloon 1308 and / or the positioning balloon 1318). The valve housing 1360 may include a cap 1368, which can be coupled to the valve housing 1360 via a tether 1370 or other connector (e.g., a hinge). The cap 1368 may be detachably coupled to the distal end of the valve housing 1360 and may be configured and / or arranged to cover the first valve 1352 and / or the second valve 1354 when closed (e.g., engaged with the distal end 1364) and configured to allow access to the first valve 1352 and the second valve 1354 when open (e.g., disengaged from the distal end 1364). In some embodiments, the valve housing 1350 may not include the cap 1368.

[0268] Valve system 1350 may be functionally similar to valve systems 826 and 1150 described above and shown in Figures 29-30 and 54, and may include a first valve 1352 configured to be in fluid communication with a first expansion medium conduit 1344 and a second valve 1352 configured to be in fluid communication with a second expansion medium conduit 1346. In some cases, the first valve 1352 and the second valve 1354 may be a check valve, a duckbill valve, a silicone valve, a check valve, a Halkey Roberts valve, a Luer-type check valve, a check valve with a polycarbonate body, and / or combinations thereof. Using a polycarbonate body for the first valve 1352 and / or the second valve 1354 can reduce and / or eliminate the risk of the valve being accidentally operated, resulting in a breach of the seal and pressure loss.

[0269] In some embodiments, valve housing 1350 may accommodate fewer or more (e.g., 3-6) valves. Alternatively, in some embodiments, system 1301 may not use valves or valve housing 1350, and in these embodiments, the inflation medium source may be directly coupled to the first inflation medium conduit 1344 and / or the second inflation medium conduit 1346 and / or tube 1348.

[0270] Figure 60 is a detailed exploded view of the valve system 1350 shown in Figure 59. As can be seen from Figure 60, the first valve 1352 can be aligned with the first opening 1366a (and ultimately inserted as shown in Figure 58), and the second valve 1354 can be aligned with the second opening 1366b (and ultimately inserted as shown in Figure 58). The first valve 1352 and / or valves 1352 and 1354 can be secured within the valve housing 1360 by any suitable means, including but not limited to chemical, thermal, mechanical (e.g., interference fit and / or friction fit) and / or vibrational engagement. The distal tip or end of the first valve 1352 and / or the second valve 1354 may be configured to allow coupling (e.g., Luer coupling, friction fit, etc.) to and / or insertion (e.g., syringe, pump, or squeeze ball) to an inflation medium source 1380, and to connect the inflation medium source 1380 to the first valve 1352 and / or the second valve 1354 for respectively connecting the first inflation medium catheter and / or the second inflation medium catheter and / or the inner sheath 1308 and / or the positioning balloon 1318. Exemplary inflation media include, but are not limited to: saline, air, gas, hydrogel, water, Newtonian fluids, and / or non-Newtonian fluids.

[0271] In some embodiments, the valve housing 1360, the tube 1348, and / or the first valve 1352 and / or the second valve 1354 may be manufactured separately, assembled together, for example, as shown in FIG60, and then permanently and / or detachably joined together. The valve housing 1360 may be formed of a flexible material, such as silicone or vinyl resin.

[0272] During use, the system 1300 can be positioned within the patient's vagina (e.g., vagina 103), allowing the patient's cervix (e.g., cervix 101) to reside within the internal passage 1370, while a portion of the tube 1348 and valve housing 1360 remains outside the vaginal opening and accessible to a clinician. The clinician can insert or otherwise engage the first and / or second valves into or connect the inflation medium source 1380, and transfer the inflation medium to / from the corresponding first and / or second inflation medium catheters for transfer to / from the inner cuff 1308 and / or positioning balloon 1318, respectively, so that the inner cuff 1308 and / or positioning balloon 1318 can inflate and / or contract as needed.

[0273] Because the body 1302 is positioned within the vagina during use, it may be difficult to assess (e.g., by visual or otherwise observation) how much pressure the inner cuff 1308 and / or positioning balloon 1318 exert on the patient tissue. To facilitate such assessment, the valve housing 1360 may include and / or be physically and / or communicatively coupled to one or more sensors 1390, the sensors 1390 being configured to, for example, directly and / or indirectly measure and / or monitor one or more aspects of the operation of the system 1301, including but not limited to the amount of back pressure exerted by the inflation medium present in the first catheter 1344 and / or the second 1346, the flow rate of the inflation medium entering and / or exiting the first catheter 1344 and / or the second catheter 1346, the volume of the inflation medium entering and / or exiting the first catheter 1344 and / or the second catheter 1346 and its changes, etc. In some embodiments, the sensor 1390 may be and / or include a tactile or visual pressure gauge having a display disposed on the valve housing 1360.

[0274] In some embodiments, sensor 1390 may include a first pressure gauge 1392 and a second pressure gauge 1394, the first pressure gauge 1392 being disposed in series between a first valve 1352 and a first inflation medium conduit 1344, and the second pressure gauge 1394 being disposed in series between a second valve 1354 and a second inflation medium conduit 1346, to measure the inflation medium pressure within the respective first inflation medium conduit 1344 and second inflation medium conduit 1346. In some embodiments, the first pressure gauge 1392 and / or the second pressure gauge 1394 may be tactile pressure gauges (e.g., pressure balloons) that can incrementally inflate to indicate the amount of pressure increase within components of system 1300, and in some cases, may be configured to indicate the amount of pressure increase and / or decrease within their respective conduits in a discretely incremental manner. For example, Figure 61E provides a cross-sectional view of an exemplary pressure gauge 1392 having a base 1396. The upper surface of the base 1396 (as shown in Figure 61E) has a varying or stepped height, wherein a central portion 1396a has a first height, a first ring 1396b surrounding the central portion 1396a has a second height, and a second ring 1396c surrounding the first ring 1396b and defining the outer periphery of the pressure gauge 1392 has a third height, wherein the first central portion 1396 is higher than the first ring 1396, and the first ring 1396b is higher than the second ring 1396c. The upper surface of the base 1396 (i.e., the central portion 1396a, the first ring 1396b, and the second ring 1396c) may comprise a flexible material (e.g., silicon, latex, etc.) that expands when pressure is applied thereon and contracts when pressure is removed thereon. In other words, the central portion 1396a can protrude from the valve housing 1350 in response to a first inflation pressure, the central portion 1396a and the first ring 1396b can protrude from the housing 1350 in response to a second inflation pressure higher than the first inflation pressure, and the central portion 1396a, the first ring 1396b, and the second ring 1396c can protrude from the housing in response to a third inflation pressure higher than the second inflation pressure. Therefore, the thinnest first thickness protrusion in the central portion 1396a can represent the lowest first inflation pressure, the second thickness protrusion in the first ring 1396b can represent a second inflation pressure higher than the first inflation pressure, and the third thickness protrusion in the second ring 1396c can represent a third inflation pressure higher than the second inflation pressure.

[0275] Additionally or alternatively, in some embodiments, the first pressure gauge 1392 and / or the second pressure gauge 1394 may include visual color indicators. For example, the central portion 1396a, the first ring 1396b, and / or the second ring 1396c may be color-coded, such that, for example, the central portion 1396a is a first color, the first ring 1396b is a second color, and the second ring 1396c is a third color. Any color that allows a user to visually distinguish different portions or areas may be used. Visual color indicators or other visual indicators can help clinicians or users determine the pressure within the pressure sensor without relying on tactile sensitivity (e.g., when wearing surgical gloves or examination gloves, tactile sensitivity may be limited). In some cases, the visual indicator may be a color, pattern, symbol, number, or other marking.

[0276] Figure 62A is a perspective view of system 1301, and Figure 62B is a cross-sectional view of system 1301, showing that the inflation medium source 1380 (implemented in the form of a syringe) is located within the second valve 1354 and is in fluid communication with the second inflation medium conduit 1346 and the positioning balloon 1318, with the positioning balloon in a contracted or neutral state. Since the positioning balloon 1318 of system 1300 is in a neutral or contracted state, the second pressure gauge 1394 is in a neutral state, indicating a neutral (e.g., atmospheric) pressure level in the positioning balloon 1318 and the second inflation medium conduit 1346.

[0277] The syringes in Figures 62A-62B include a syringe 1382 filled with a certain volume of expansion medium 1384, a needle 1386 fluidly communicating with the syringe 1382, and a plunger 1388 fluidly fitted within the syringe 1382. As arranged in Figures 62A and 62B, the plunger 1388 extends outward from the syringe 1382, allowing the volume of the expansion medium 1384 to reside within the syringe 1382, for example, when it is necessary to introduce the expansion medium into the second valve 1354 and the second expansion medium conduit 1346 to communicate with the positioning balloon 1318 (thereby inflating the positioning balloon 1318), or when negative pressure is generated by pulling the plunger 1388 out of the syringe 1382, thereby withdrawing the expansion medium from the positioning balloon 1318 (thereby contracting the positioning balloon 1318).

[0278] Figure 63A is a perspective view of system 1301, and Figure 63B is a cross-sectional view of system 1301, showing that the inflation medium source 1380 (implemented in the form of a syringe) is located in the second valve 1354 and is in fluid communication with the second inflation medium conduit 1346 and the positioning balloon 1318, wherein the positioning balloon 1318 is in an inflated or expanded state after a portion of the volume of the inflation medium 1384 is transferred from the syringe 1382 to the second valve 1354, the second inflation medium conduit 1346 and the positioning balloon 1318, thereby inflating the positioning balloon 1318 as shown in the figure. When the plunger 1368 is pressed (i.e. pushed toward the needle 1386) into the syringe 1382, the volume of the inflation medium 1384 can be transferred from the syringe 1382 to the second valve 1354, the second inflation medium conduit 1346, and the positioning balloon 1318. This can apply pressure to the volume of the inflation medium 1384, causing the inflation medium 1384 to move through the needle 1386 and into the second valve 1354, the second inflation medium conduit 1346, and the positioning balloon 1318, thereby inflating the positioning balloon 1318 as shown. The plunger 1388 can be pressed down by, for example, a clinician and / or a mechanical device (e.g., a pump or robot (not shown)). When the positioning balloon 1318 is inflated as shown in Figures 63A and 63B, the pressure gauge 1394 can indicate the pressure level in the second catheter 1346 (and therefore the positioning balloon 1318) by inflating in a manner similar to that described above with respect to Figures 61A-61D. Figure 63B also shows the lumen 1350 of the inner cuff 1308. When an inflation medium is added to the lumen 1350, the inner cuff 1308 (or a flexible membrane comprising the inner cuff or a portion thereof) can expand to accommodate the increase in volume of the inflation medium present within the lumen 1350, thereby inflating or expanding the inner cuff 1308.

[0279] When it is necessary to inflate and / or deflate the inner bladder 1308, the inflation medium source 1380 can be removed from the second valve 1354 and inserted into the first valve 1352, thereby injecting a certain volume of inflation medium 1384 into the first valve 1352 to communicate with the first conduit 1344 and the inner bladder 1308, thus inflating the inner bladder 1308. The inner bladder 1308 can be deflated by the reverse process. Alternatively or additionally, the inner bladder 1308 can be inflated by inserting a second inflation medium source 1380 (not shown), embodied as, for example, a syringe or pump, into the first valve 1352, such that a certain volume of inflation medium 1384 can be injected into the first valve 1352 to communicate with the first conduit 1344 and the inner bladder 1308, thereby inflating the inner bladder 1308. The inner bladder 1308 can be deflated by the reverse process.

[0280] In some embodiments, variations in the wall length and wall thickness of one or more positioning balloons disclosed herein can be used to control the direction of expansion of the positioning balloons when compressed (i.e., inflated and / or filled with an inflation medium) due to the properties of, for example, the materials used to manufacture the positioning balloons and / or the associated cervical control system (e.g., silicon). For example, Figure 64A provides a cross-sectional view of a portion of a cervical control system 1400 (also referred to herein as “System 1400”), similar to, for example, a cervical control system 1300 having a positioning balloon 1418 with varying wall thickness in a neutral or contracted state, and Figure 64B is a cross-sectional view of a portion of System 1400 with the positioning balloon 1418 in an inflated or swollen state.

[0281] Positioning balloon 1418 (in terms of, for example, size, placement extending from the outer surface of system 1400, manner of inflation via the inflation medium conduit, and function) may be similar to positioning balloon 1318. Positioning balloon 1418 may have a proximal wall 1422, a distal wall 1424, and a vertical wall 1426 (extending from the proximal wall 1422 to the distal wall 1424). The vertical wall 1426, proximal wall 1422, distal wall 1424, and the outer surface of body 1402 form positioning balloon chamber 1450, which may be filled with an inflation medium (see, for example, FIG. 64B) to inflate or expand positioning balloon 1418. The initial length L1 of the proximal wall 1422 may be equal to, substantially equal to, and / or not equal to the initial length L2 of the distal wall 1424 to adjust the inflation direction of positioning balloon 1418. In the examples of Figures 64A and 64B, the length L1 of the proximal wall 1422 is approximately equal to the length L2 of the distal wall 1424. This allows the positioning balloon 1418 to expand outwards away from the outer surface of the body 1402, and primarily in a direction perpendicular to the transverse plane of the system body 1402 and / or parallel to the distal opening of the system 1400. Continuing with the examples of Figures 64A and 64B, the thicknesses (T1) of the proximal wall 1422 and (T2) of the distal wall 1424 are smaller than (i.e., have a smaller dimension) the thickness (T3) of the vertical wall 1426.

[0282] For example, due to the properties of the materials contained in the positioning balloon 1418, the different thickness T3 of the vertical wall 1426, compared to T1 and T2 of the proximal wall 1422 and the distal wall 1424 respectively, can help provide outward (oriented to the left in FIG. 64B) expansion of the positioning balloon 1418, while limiting expansion in the distal and proximal directions as shown in FIG. 64B. In this way, the configuration shown in FIG. 64A allows the positioning balloon 1418 to expand outward from the outer surface of the body 1402 and away from the axial center of the distal opening in a direction substantially perpendicular to the transverse plane of the system body 1402 and / or substantially parallel to the distal side of the cervical control system, as indicated by the arrow in FIG. 64B, thereby making the positioning balloon chamber 1450 have a wider rectangular shape in the inflated state (FIG. 64B) than in the neutral state (FIG. 64A). Although the cross-section of the positioning balloon shown in Figures 64A-64B is shown as rectangular or substantially rectangular, the cross-section of the positioning balloon can be circular or substantially circular, semi-circular or substantially semi-circular, triangular or substantially triangular, inverted triangular or substantially inverted triangular, square or substantially square, elliptical or substantially elliptical, partially elliptical or partially substantially elliptical, irregularly shaped with an asymmetrical cross-section, or any other shape capable of providing support and / or engaging with the vaginal wall. In some cases, the cross-sectional shape of the positioning balloon 1418 can be inverted triangular or substantially inverted triangular, which can expand or contract with the vertices of the triangle acting as hinges.

[0283] The exemplary thicknesses T1 and T2 of the proximal wall 1422 and / or the distal wall 1424 may range from 0.3-2 mm, 0.1-1.5 mm, 0.2-1 mm, 0.4-0.8 mm, 0.3-0.6 mm, 0.1-0.5 mm, and overlapping ranges therein. The thickness T3 of the vertical wall 1426 may range from 0.88 mm and / or 0.4-2 mm, 0.6-1.8 mm, 0.8-1.6 mm, 1-1.4 mm, 0.8-1 mm, and overlapping ranges therein. As described herein, in some cases, the selected wall thickness may respond to and / or depend on the hardness grade and / or hardness tester of the material used. For example, when silicone is used, the selected wall thickness may respond to and / or depend on the hardness grade and / or hardness tester of the silicone. For example, when using a lower hardness silicone (e.g., 10A), the wall thickness of T1 and / or T2 may be relatively large (e.g., 1-2 mm); while when using a higher hardness silicone (e.g., 40A-80A on the Shore A scale) and / or a more elastic / tear-resistant material (e.g., silicone dispersion), the wall thickness of T1 and / or T2 may be relatively small (e.g., 0.95-0.05 mm). For example, when the silicone hardness is selected as 20A, 30A, 40A, or 50A, the wall thickness of T1 and / or T2 can be 0.3 mm, 0.4 mm, 0.5 mm, 0.6 mm, 0.7 mm, 0.8 mm, and overlapping ranges therewith. In some embodiments, the silicone hardness selection range can be 10A-70A. In some cases, for expandable walls, the wall thickness can be greater than or equal to 0.1 mm, assuming the wall is being stretched and the manually operated 10cc syringe used can output a pressure of approximately 20 psi. In some cases, for silicone hardness selection with hardness grades of 10A-30A, wall thicknesses T1 and T2 can range from approximately 0.1 to 2 mm. In some embodiments (e.g., hardness grades of 40A-50A), wall thicknesses T1 and T2 can range from 0.1 mm to 1 mm, while in other embodiments (e.g., hardness grades of 60A-70A), wall thicknesses T1 and T2 can range from approximately 0.1 to 0.5 mm. Although the wall thicknesses and hardnesses described herein are described with reference to T1 and T2, these examples of wall thicknesses and associated hardness grades can be used for any wall thickness of any expandable wall and / or membrane in a cervical control system.

[0284] In some embodiments, the inner sheath disclosed herein may also be designed and / or configured to achieve directional expansion, for example by utilizing material properties and / or its dimensions, as shown, for example, in Figures 9-12, 34 and 64A, 64B as described herein, particularly with respect to Figures 9-12 and 34. Another example of an inner sheath with varying wall thickness is shown in Figures 65A and 65B, which is capable of achieving directional expansion in a preferred direction, as will be discussed below. In particular, Figure 65A is a cross-sectional view of an exemplary cervical control system 1500 (also referred to herein as “System 1500”), showing an inner sheath 1508 in a neutral state, a positioning balloon 1518 in a neutral state, and a cervix 101 located within an internal passage 1570 of System 1500. Figures 65A and 65B include a first dashed line 1501 and a second dashed line 1502, the space between the first dashed line 1501 and the second dashed line 1502 defining the proximal plane 1503 of the inner sheath 1508 in the intermediate state shown in Figure 65A.

[0285] As shown in Figure 65A, once the cervix 101 is positioned within the internal passage 1570, the inner sheath 1508 can be inflated by, for example, by an inflating medium pushed into the first inflating medium conduit 1544, in a manner similar to that described above with respect to Figures 58-63, and particularly with respect to Figures 62A-63B. During inflatation, the inner sheath 1508 expands directionally toward the internal passage and downwards (as shown in the cross-sectional view of Figure 65B) across the second dashed line 1502, causing the wedge 1516 to press into the outer surface of the cervix 101 and the cervical tissue, further pushing the cervical tissue downwards into the internal passage, thereby elongating the cervix 101 as shown in Figure 65B.

[0286] The directional expansion of the inner cuff 1508 can be achieved by changing the wall thickness of the material constituting the inner cuff 1508, as disclosed herein with reference to, for example, Figures 9-12, 34, and 64A and 64B. As shown in Figures 65A and 65B, the proximal cuff 1508 includes a chamber 1520 communicating with a first inflation medium conduit 1544. When in a neutral state, the chamber 1520 is defined or constrained by an inner wall 1521 having an approximately elongated semi-circular shape. The outer surface of the inner cuff 1508 is defined by an outer wall 1523, in which a wedge 1526 is molded. When in a neutral state (e.g., FIG. 65A), the space between the inner wall 1521 and the outer wall 1523 is relatively narrow at the proximal and distal wall portions, but wider at the curved apex of the inner sheath 1508, making the material constituting the inner sheath 1508 thicker at the apex (i.e., towards the apex of the approximately semi-circular curve of the inner sheath 1508) than at the proximal and distal wall portions. When the inner sheath 1508 is pressurized by introducing an expansion medium into the chamber 1520, the apex portion stretches or thins (e.g., thins by 10%-95%), causing the chamber 1520 to expand to accommodate the pressurization caused by introducing the expansion medium into the chamber 1520 in the preferred direction shown in FIG. 65B. The expansion of the inner sheath 1508 (e.g., radially inward and / or radially downward) serves, for example, to press the wedge 1516 into the cervical tissue, thereby increasing the engagement between the wedge 1516 and the cervical tissue. Additionally or alternatively, expansion of the inner sac 1508 (e.g., radially inward and / or radially downward) can be used to engage the cervix 101, push it to close, and / or pull it downward (relative to the first dashed line 1510 and the second dashed line 1502), thereby compressing and / or stretching the cervix 101 from its original state (see, for example, FIG. 65A) to the compressed and / or stretched state shown in FIG. 65B, which may be helpful, for example, in preventing preterm labor and / or treating PPROM.

[0287] In other words, the stretching, elongation and / or compression of the cervix 101 exerted by the inflation of the inner sac 1508 can produce an anatomical state of the cervix 101 that controls cervical function (e.g., prevents dilation and / or shortening), and in some cases, can provide conditions conducive to the replacement, enlargement and / or regeneration of the cervical mucus plug (not shown) located at or near the internal os of the cervix 101.

[0288] For example, a portion of the inner cuff 1508 may expand in a plane or more planar direction toward the axial center of the proximal opening of the cervical control system, while another portion of the inner cuff may expand in a slightly distal direction. This allows the cervical control system to intentionally distort the cervix. In some cases, the inner cuff may be sized such that its outer diameter is less than or equal to the diameter of the cervix, thus providing mechanical pressure on the cervix even in a neutral or uninflated state. In some cases, the inner cuff may expand radially inward but not distally. In other cases, the inner cuff may expand distally but not radially inward. In still other cases, the inner cuff may expand only proximally, or radially inward and proximally.

[0289] Figure 66 shows a side sectional view of a portion of an exemplary cervical control system 1600 (also referred to herein as "System 1600"). System 1600 may resemble and / or have features common to, for example, systems 100, 500, 1000, 1100, 1300, 1400, and 1500 as described above and shown in Figures 1-6, 19-20, 36-37, 51-54, 58-59, 64A-64B, and 65A-65B, respectively. For example, System 1600 has a body 1602, an inner sheath 1608, and a wedge 1616 that may surround and extend from the inner periphery of the inner sheath 1608 in a manner similar to, for example, a wedge 1316 that surrounds and extends from the inner periphery and / or outer surface of the inner sheath 1308 of System 1300. The inner bladder 1608 is configured and designed with different wall thicknesses and partial lengths, which facilitates expansion in preferred directions (e.g., radial and / or distal directions). For example, the inner bladder 1608 may have a proximal wall 1632 of a first thickness T1 and a first length L1, a distal wall 1634 of a second thickness T2 and a second length L2, and a tip portion 1636, as shown, which connects the proximal wall 1632 and the distal wall 1634 to form the inner bladder 1600, thereby forming the cavity 1650. As shown in Figure 66, the tip portion 1636 may have a third thickness T3 at the apex or center point of the wedge 1616, while the remainder of the tip portion 1636 (i.e., the portion excluding the wedge 1616) may have a fourth thickness T4. In some cases, the thicknesses T1 and T2 of the proximal wall 1632 and the distal wall 1634 may be less than the thicknesses T3 and T4 of the tip portion 1636, which allows the inner bladder 1608 to expand in a radially inward direction when the inner bladder 1608 is pressurized (i.e., when the inflation medium is added to the inner cavity 1650). Exemplary ranges of the first and / or second thicknesses T1 and / or T2 of the proximal wall 1632 and / or the distal wall 1634 include approximately 0.5 mm to 3 mm, 0.1 mm to 1.5 mm, 0.2 mm to 1 mm, 0.4 mm to 0.8 mm, 0.3 mm to 0.6 mm, and overlapping ranges therein. The exemplary third thickness T3 of the tip portion 1636 having the wedge 1616 may include approximately 1.65 mm and / or 1 mm-2 mm, 1.2 mm-1.8 mm, 1.4 mm-1.7 mm, 1.5 mm-1.7 mm, 1.6 mm-1.65 mm, and overlapping ranges therein. The exemplary thickness range of the tip portion 1636 of the fourth thickness T4 without the wedge 1616 includes approximately 0.88 mm and / or 0.4 mm-2 mm, 0.6 mm-1.8 mm, 0.8 mm-1.6 mm, 1 mm-1.4 mm, 0.8 mm-1 mm, and overlapping ranges therein.The range of the third thickness at the thickest point of wedge 1616 includes approximately 1.9 mm and / or 1-3 mm, 1.5 mm-2.5 mm, 1.8 mm-2.2 mm or 1.9 mm, and the overlapping range therein.

[0290] As shown in Figure 66, the inner sac 1608 may have an inner wall 1638 extending from the proximal wall 1632 to the distal wall 1634 and defining an edge of the chamber 1350 that is generally opposite the apical portion 1636. The inner wall 1638 may be parallel to the axial center of the cervical control system. In other cases, the inner wall 1638 may be inclined upward or downward relative to the axial center of the cervical control system, or inclined (e.g., 90-170 degrees) relative to the upper side (oriented in Figure 66) of the distal wall 1634. The angle of the inner wall 1638 shown in Figure 66 may facilitate the expansion of the chamber 1350 and / or the inner sac 1608 in a preferred (e.g., downward) direction, which may help, for example, elongate the cervix near the inner sac 1608 and / or guide the cervix into a desired position within the system 1600. The inner sac 1608 may be designed to have a downward bias in a neutral or contracted state, such that even if the inner wall 1638 is tilted upward, the inner sac 1608 may expand in a downward direction when inflated as described herein. As shown in Figure 66, the cross-section of the inner sac 1608, which is engaged with the outer surface of the body, may be an irregularly shaped cross-section with an asymmetrical cross-section. Although the cross-sections of the inner sac 1408 and the lumen 1450 shown in Figures 64A-64B are shown to have generally “D”-shaped asymmetrical cross-sections, the cross-sectional shapes of the inner sac 1408 and the lumen 1450 may have any suitable shape, including but not limited to rectangles, parallelograms, circles, substantially circular, semicircles, substantially semicircles, triangles, substantially triangular, squares, substantially squares, ellipses, substantially ellipses, partially ellipses, partially substantially ellipses, or any other shape that can help the lumen 1450 and / or the inner sac 1408 perform, for example, control, support, and / or engagement of the cervix.

[0291] Additionally or alternatively, the length L1 of the proximal wall 1632 and the length L2 of the distal wall 1634 can be varied to control the directional expansion of the inner cuff 1608. For example, the length L1 of the proximal wall 1632 can be greater than the length L2 of the distal wall 1634, which can promote the expansion of the inner cuff 1608 in the distal direction when the inner cuff 1608 is pressurized.

[0292] Figures 67A-67C and 68A-68B show various views of the cervical control system 1700 in situ, which may have similar features and / or functions to, for example, the systems 100, 500, 1000, 1100, 1300, 1400, 1500 and / or 1600 described herein and shown in Figures 1-6, 19-20, 36-37, 51-54, 58-59, 64A-64B, 65A-65B and 66. For example, system 1700 includes a body 1702, a proximal opening 1704, a distal opening (not shown), an internal channel 1770, an inflatable annular inner bladder 1708 having a recessed portion 1710 and an inflatable portion 1712, a positioning balloon 1718 located near the distal opening and on the outer surface of the body 1702, and a plurality of wedges 1716 disposed on the outer surface and / or inner periphery of the inner bladder 1708. These components may be similar to and / or combined with the features of the body, proximal opening, distal opening, internal channel, and inflatable annular inner bladder, positioning balloon, and / or wedges of systems such as systems 100, 500, 1000, 1100, 1300, 1400, 1500, and / or 1600 as described herein and illustrated in the accompanying drawings.

[0293] Figures 67A-67C show top or distal (when in situ) views of the cervical control system 1700, wherein the cervix 101 (shown as a circle in Figure 67A and as a dashed line in Figures 67B and 67C) is located within the internal passage 1770. Figures 67A-67C also show the two main vessels 1794 of the cervix 101, which are located within the recessed portion 1710 of the system 1700 in Figures 67A-67C. Figures 67A-67C also provide a first pair of dashed lines, including the first dashed line 1751 and the second dashed line 1752, located above and below the system 1700 (in the direction shown in the figure) when the inner balloon 1708 and the positioning balloon 1718 are in the contracted state, and a second pair of dashed lines, including the third dashed line 1753 and the fourth dashed line 1754, located above and below the inner cuff 1708 (in the orientation shown in the figure) when the inner balloon 1708 and the positioning balloon 1718 are in the contracted state, so that the relative change in size between the inner cuff 1708 and the outer cuff 1718 can be observed in the neutral and inflated states.

[0294] Specifically, Figure 67A shows a distal view of system 1700, wherein both the inner cuff 1708 and the positioning balloon 1718 are in a neutral or contracted state, for example, when system 1700 is placed within the patient's vagina 103 and the cervix 101 is placed within the internal passage 1770. Figure 67B shows a distal view of system 1700, wherein the inner cuff 1708 is pressurized or inflated to apply pressure around the cervix 101, and the positioning balloon 1718 is in an uninflated state (see the bulging portions of the oriented inner cuff 1708 extending beyond the third and fourth dashed lines 1703 and 1704 in Figure 67B). When the inner sac 1708 is pressurized or inflated, the expandable portion 1712 can expand or extend radially inward, as shown in Figures 67B and 67C, to apply pressure around the cervix 101 excluding the blood vessels 1794, and the recessed portion 1710 can remain uninflated or recessed (i.e., not expanding or extending radially inward, or only expanding or extending radially inward to a minimum), such that the pressure caused by the inflation of the inner sac 1708 is not applied (or is applied in a smaller amount) to the cervical blood vessels 1794. This allows the expandable portion 1712 of the inner sac 1708 to compress most of the circumferential area of ​​the cervix 101 near the blood vessels 1794 (i.e., the portion near the expandable portion 1712), while the recessed portion 1710 of the inner sac 1708 remains uninflated or minimally inflated, and the cervical arteries are not compressed (or are compressed less), thereby allowing blood to flow through the blood vessels 1794 relatively unaffected by the pressure caused by the inflation of the inner sac 1708.

[0295] In some embodiments, the inner bladder 1708 may be formed with an inflatable portion 1712 and a recessed portion 1710 of the inner bladder 1708 using a material with variable wall thickness (e.g., a flexible membrane), wherein the wall thickness of the recessed portion 1710 is greater than (and therefore more resistant to expansion) the wall thickness of the inflatable portion 1712. This arrangement allows the inflatable portion 1712 to expand or inflate at a lower pressure than the recessed portion 1710. Additionally or alternatively, the recessed portion 1710 may be a notch and / or recess in the wall and / or flexible membrane of the inner bladder 1701. Although Figures 67A-67C show a recessed portion 1710 having a generally circular-rectangular shape, the recessed portion 1710 may be any suitable shape, including, for example, a semicircle, an ellipse, a trapezoid, a parallelogram, an irregular shape, and combinations thereof.

[0296] Figures 67A-67C illustrate a recessed portion 1710 of the inner cuff 1708, located on opposite sides of the inner cuff 1708 (e.g., approximately 180 degrees apart). However, the recessed portion 1710 may be located at any necessary and / or preferred location along the inner cuff 1708 to prevent obstruction of blood vessels (such as vessel 1704) and / or avoid restricting blood supply from arteries and / or veins to the cervix 101. In some cases, as shown in Figure 67A, the recessed portion 1710 is present in the inner cuff 1708 before the inner cuff 1708 is inflated or expanded, but this is not mandatory. In some cases, when the inner cuff 1708 is pressurized, the internal volume of the recessed portion 1710 may increase as the inflatable portion 1712 expands or extends radially inward.

[0297] Figure 67C shows a distal view of system 1700, in which the inner sac 1708 is pressurized or inflated to apply pressure around the cervix 101 (as shown in Figure 67B and described above), and the positioning balloon 1718 is in an inflated or expanded state (see the expanded portion of the lower edge of the positioning balloon 1718 (oriented in Figure 67C) extending beyond the second dashed line 1752).

[0298] Figure 68A provides a top view of system 1700 when it is not in situ (i.e., cervix 101 is not positioned within internal passage 1770), and Figure 68B provides a 90-degree cross-sectional view of system 1700 (along dashed lines 1756 and 1757 shown in Figure 68A). As shown in Figure 68B, the inner sheath 1708 can be circumferentially positioned around system 1700 at its proximal end, and the wall thickness of the recessed portion 1710 can be greater than the wall thickness of the expandable portion 1712. This can result in and / or contribute to a larger lumen 1713 of expandable portion 1712 than the lumen 1711 of recessed portion 1710. The larger lumen 1713 of expandable portion 1712 has a larger volume than the lumen 1711 of recessed portion 1712 and can accommodate more expansion medium. This volume difference can contribute to the greater expansion capacity of expandable portion 1712 compared to the expansion capacity of recessed portion 1710.

[0299] In other cases, the inner cuff may be segmented, rather than extending circumferentially around the cervical control system, to provide an inflatable and recessed portion. In this case, a conduit or catheter assembly may be provided for each segment to provide pressure to each individual segment. In some cases, the inner cuff does not include a recessed and inflatable portion. In some cases, the inner cuff does not have a varying wall thickness.

[0300] Figures 69A-69H provide various views of system 1801, which includes a cervical control system configured with a single valve and its components. Specifically, Figure 69A provides a top view of an exemplary single-valve system 1850, Figure 69B provides a perspective view of an exemplary single-valve system 1850, and Figure 69C provides a cross-sectional view of an exemplary single-valve system 1850 (cut along the vertical bisecting dashed line 69C of Figure 69A). The single-valve system 1850 includes a single-port valve housing 1860, a single valve 1854, a valve seat 1852, and a valve cover 1868. The valve cover 1868 includes an extension 1867 defining a recessed region 1865. The extension 1867 is sized, positioned, and configured to sleeve over and protect a portion of the valve 1854, which extends from the valve seat 1852 and lies within the recessed region 1865 when the valve cover 1868 is closed, for example, by pushing it onto the valve 1854. The single-port valve housing 1860 can be configured to house the valve 1854 in a manner similar to, for example, valve housing 1360. The valve 1854 can be, for example, a check valve, a duckbill valve, a silicone valve, a check valve, a Halkey Roberts valve, a Luer-type check valve, or a check valve with a polycarbonate body.

[0301] As can be seen from the cross-section of Figure 69C, the single-port valve housing 1860 may include a channel 1846 configured to mate with an expansion medium conduit that can be in fluid communication with one or more components of a cervical control system (such as cervical control systems 1800A and / or 1800B shown in Figures 69D-69H).

[0302] Figure 69D shows a top view of an exemplary cervical control system 1800A or cervical control system 1800B having a single inflatable medium catheter; Figure 69E shows a cross-sectional view of the cervical control system 1800A (also referred to herein as system 1800A) taken along the dashed bisecting line 69E-69F of Figure 69D; Figure 69F shows a cross-sectional view of the cervical control system 1800B (also referred to herein as system 1800B) taken along the dashed bisecting line 69E-69F of Figure 69D. For example, as shown in Figures 69G-69H, cervical control systems 1800A and / or 1800B may be included in system 1801. Like many cervical control systems disclosed herein, systems 1800A and 1800B include a body 1802, a proximal opening 1804, a distal opening 1806, an internal passage 1870, an inflatable annular inner sac 1808 (also referred to herein as “inner sac 1808”) having a recessed portion 1810 and an inflatable portion 1812, a flexible membrane (the flexible membrane defining an inner lumen 1855 (also referred herein as “inner sac lumen 1855”)), and a positioning balloon 181 positioned near the distal opening 1806 and on the outer surface of the body 1802. 8 (The positioning balloon 1818 includes a flexible membrane defining the inner cavity 1850 of the positioning balloon), a plurality of wedges 1816 arranged on the outer surface and / or inner periphery of the inner sheath 1808, these components being similar to and / or including, for example, the body, proximal opening, distal opening, internal channel, inflatable annular inner sheath having recessed and inflatable portions, positioning balloon and / or corresponding features of the system 100, 500, 1000, 1100, 1300, 1400, 1500, 1600 and / or 1700 as described herein and shown in the accompanying drawings, as well as corresponding features of the teeth.

[0303] System 1800A also includes an inflation medium conduit 1844 extending from an inlet 1820 (which may be similar in form, function, and / or construction to inlet 120) to a transverse channel 1846; both are in fluid communication with the lumen 1850 of the positioning balloon, as shown. System 1800A also includes an inner cuff inflation medium conduit 1848 extending from and in fluid communication with the inflation medium conduit 1844. During inflation, inflation medium can be pushed into the inflation medium conduit 1844 through inlet 1820. From there, inflation medium can be pushed into the inner cuff inflation medium conduit 1848 and collected in the lumen 1855, while simultaneously being pushed into the transverse channel 1846 and collected in the lumen 1850 of the positioning balloon, filling at a relatively uniform rate such that, for example, the lumen 1855 and the lumen 1850 of the positioning balloon are filled with inflation medium at approximately the same rate. In embodiments where the inner lumen 1855 and the positioning balloon inner lumen 1850 have the same or similar total volume, the inner cuff 1808 and the positioning balloon 1818 can inflate at approximately the same rate when the inflation medium is added to the inflation medium catheter 1844. In embodiments where the volume of the inner lumen 1855 is smaller than the volume of the positioning balloon inner lumen 1850, the inner cuff 1808 can inflate at a faster rate than the positioning balloon 1818. In embodiments where the volume of the inner lumen 1855 is larger than the volume of the positioning balloon inner lumen 1850, the inner cuff 1808 can inflate at a slower rate than the positioning balloon 1818.

[0304] Similar to system 1800A, system 1800B also includes an inflation medium conduit 1844 extending from inlet 1820 to transverse channel 1846. However, a throttling point 1846 is provided within transverse channel 1846, configured and positioned to slow the flow rate of inflation medium entering the lumen 1850 of the positioning balloon. This causes the inflation medium to flow through inflation medium conduit 1844 to the inner balloon inflation medium conduit 1848 at a faster rate than through throttling point 1848 in transverse channel 1846, and causes the lumen 1855 to fill faster than the lumen 1850 of the positioning balloon, thereby allowing the inner balloon 1808 to inflate before the positioning balloon 1818. Therefore, throttling point 1846 allows the inner balloon 1808 to expand around, for example, a cervix (e.g., cervical 101) located within the internal channel, before the positioning balloon 1818 inflates. This allows clinicians to secure the System 1800B to the patient's cervix (by the expansion of the inner sheath 1808) before repositioning (e.g., adjusting the angle) the cervix or otherwise installing the System 1800B into the patient's vagina and / or expanding the positioning balloon 1818 to hold the System 1800B in place.

[0305] Figure 69G is an exploded view of system 1801, and Figure 69H is an assembled view of system 1801. As shown in Figure 69G, the positioning balloon 1818 can be aligned and positioned with the main body 1802 of system 1800A or system 1800B, and is fixed to the system as shown in Figure 69H. System 1801 also includes a tube 1848, which can be aligned and positioned with inlet 1820, so that when assembled as shown in Figure 69H, fluid communication can be established between tube 1848 and inflation medium conduit 1844. As shown in Figure 69G, tube 1848 can be aligned with a first side of single-port valve housing 1860, and valve 1854 can be aligned with a second side of single-port valve housing 1860, and are assembled together as shown in Figure 69H to form system 1801.

[0306] System 1800 also includes an inner cuff inflation medium conduit 1848 extending from and in fluid communication with the inflation medium conduit 1844. During inflation, inflation medium can be pushed into the inflation medium conduit 1844 through inlet 1820. From there, inflation medium can be pushed into the inner cuff inflation medium conduit 1848 and collected in the lumen 1855, while being pushed into the transverse channel 1846 and collected in the positioning balloon lumen 1850, filling at a relatively uniform rate such that, for example, the lumen 1855 and the positioning balloon lumen 1850 fill with inflation medium at approximately the same rate. For embodiments where the lumen 1855 and the positioning balloon lumen 1850 have the same or similar total volume, when inflation medium is added to the inflation medium conduit 1844, the inner cuff 1808 and the positioning balloon 1818 can inflate at approximately the same rate. In embodiments where the volume of the inner cavity 1855 is smaller than the volume of the inner cavity 1850 of the positioning balloon, the inflation rate of the inner cuff 1808 can be faster than the inflation rate of the positioning balloon 1818. In embodiments where the volume of the inner cavity 1855 is larger than the volume of the inner cavity 1850 of the positioning balloon, the inflation rate of the inner cuff 1808 can be slower than the inflation rate of the positioning balloon 1818.

[0307] Figures 70A-70C illustrate a cervical control system 2300 configured to support a patient's pelvic organs (e.g., uterus 105, bladder, etc.) and / or hold the uterus in place, for example, to alleviate and / or prevent uterine prolapse. Specifically, Figure 70A is a top or proximal view of the system 2300, while Figure 70B is a bottom or distal view of the system 2300. System 2300 is similar to, for example, systems 100, 500, 1000, 1100, 1300, 1400, 1500, 1600, 1700 and 22200 described above and shown in Figures 1-6, 19-20, 36-37, 51-54, 58-59, 64A-64B, 65A-65B, 66, 67A-67C, 68A-68B and 82, and may include a body 2302, a proximal opening 2304, a distal opening 2306, an inflatable inner bladder 2308 having an inflatable portion 2312 and a recessed portion 2310, an inflatable positioning balloon 2318, and teeth 2316. The inner bladder 2308 and / or the positioning balloon 2318 can be inflated and / or contracted using, for example, an inflation medium conduit, a valve, a valve body and / or an inflation medium source (such as the inflation medium conduit, valve, valve body and / or inflation medium source disclosed herein), and can utilize the two ports 2392 shown in FIG70B.

[0308] Positioning balloon 2318 is configured to extend to surround a portion (e.g., 50-95%) of the exterior of body 2302. For example, as shown in Figures 70A and 70B, positioning balloon 2318 is similar to positioning balloon 1318 because positioning balloon 2318 only covers a circumferential portion of the outer surface of body 2302. However, in the embodiments of Figures 70A and 70B, positioning balloon 2318 is a circumferentially arranged main arcuate segment (or horseshoe shape) surrounding body 2302 by more than 180 degrees and extends beyond the outer periphery of body 2302. Compared to, for example, positioning balloon 1308 and / or positioning balloons shown and / or described with reference to Figures 58-59, 62-65, and 67-68, the larger arcuate segment or main arcuate segment of positioning balloon 2318 can be particularly helpful in controlling, mitigating, and / or preventing pelvic organ prolapse because the larger arcuate shape of positioning balloon 2318 increases the overall diameter of system 2300 when inflated. This can help anchor system 2300 in place, occupy space within the vagina (thus preventing pelvic organs from entering the vagina), and / or distribute forces within the vagina (e.g., vagina 103) so that it is not limited to one or more pressure points (as might be the case with positioning balloon 1318). Furthermore, when inflated, system 2300 can provide additional mechanical support to the ligaments and tissues stabilizing the pelvic organs, naturally securing the prolapsed organs in place.

[0309] In some cases, when dealing with PPROM, the supporting ligaments can be healthy, and the pregnancy will be more restricted in the total space of the vaginal cavity. Therefore, a positioning balloon with a smaller arc or micro-arc shape may be helpful, and the positioning balloon can be used to change the cervical angle rather than to anchor the cervical control system. In some cases, the main arc segment (or horseshoe shape) allows for an increase in the diameter of the cervical control system to help anchor it and provide mechanical support for the prolapsed uterus, while still biasing the cervical control system in a specific direction using only an inflated portion of the inner sac (rather than the sac extending circumferentially along the entire circumference of the cervical control system).

[0310] In some cases, system 2300 can be oriented within the vagina such that areas of the outer surface of the main body 2302 not covered or occupied by the positioning balloon 2318 are located near and / or cover the portion of the patient's anatomy where the bladder or colon is located. Orientation in this manner prevents the positioning balloon 2318 (when inflated) from pressing on the patient's bladder or colon, thereby avoiding pressure on and / or irritation to these organs. As shown in Figure 70C, when system 2300 is oriented in this manner, inflation of the positioning balloon 2318 can anchor the cervical control system within the vagina, but it can be positioned such that the portion of the main body 2302 not covered by the positioning balloon 2318 can rest against the bladder and / or rectum. In this way, when using system 2300, inflation of the positioning balloon 2318 and / or use of the system will not compress, disrupt the operation of the bladder and / or rectum, and / or cause patient discomfort.

[0311] In other cases, system 2300 can be rotated 180 degrees from the position shown in Figure 70C, such that the positioning balloon 2318 can be positioned to press upwards into the bladder space to, for example, prevent and / or alleviate bladder prolapse. Additionally or alternatively, system 2300 can be rotated in any direction to suit patient comfort. This ability to rotate or orient system 2300 to different arrangements is beneficial to patients because while applying pressure to the bladder can benefit patients with bladder prolapse, it may stimulate patients with overactive bladders. Rotation during placement but before inflatation allows pressure to be applied to the anterior wall of the vaginal cavity. In some cases, the increased diameter provided by the inflatation of the positioning balloon 2318 can help anchor the cervical control system within the vagina.

[0312] Figure 71A provides a bottom perspective view of an exemplary cervical control system 1900 (also referred to herein as "system 1900"), and Figure 71B provides a cross-sectional view of the exemplary cervical control system 1900, which is configured to be placed on the vaginal side of the cervix to, for example, mitigate the effects of a short cervix and / or prevent preterm labor.

[0313] System 1900 shares some common features and functions with the cervical control systems disclosed herein (such as systems 100, 500, 1000, and 1100 described above and shown in Figures 1-6, 19-20, 36-37, and 51-54), such as a body 1910 including an inner sac 1905 in fluid communication with an inner sac port 1920 and an inner sac inflation medium conduit (not shown); and an internal channel 1935 including a plurality of ports 1940 and communicating with the internal channel coupled ports 1945 and the channel inflation medium conduit (not shown). Each port 1940 may be configured to allow fluid (e.g., a drug, antibacterial agent, etc.) to flow out of the internal channel, such that the fluid can flow to the inner wall of system 1900 and / or to the cervix, for example, as shown and described herein, located within the internal channel of system 1900. Multiple ports 1940 may be evenly spaced around the proximal interior of system 1900, and, for example, as shown in FIG71B, internal channels 1935 may be concentrically placed within body 1910. In other embodiments, cervical control system 1900 may include multiple channels located inside or outside cervical control system 1900. System 1900 also includes a pair or coupled channels 1915 configured for receiving and engaging the covering layer and / or flexible membrane of positioning balloon (e.g., as shown in FIG69G and 69H).

[0314] When the flexible membrane of the positioning balloon is attached via coupling channel 1915 and the system 1900 is placed near the cervix, the positioning balloon and inner sheath 1905 can be inflated with an inflation medium, such as that described herein. The communication between the internal channel 1935, port 1940, and internal channel coupling 1945 can be used, for example, via one or more ports 1940 as shown in FIG. 71B, to deliver substances (indicated by small arrows in FIG. 71B) to the cervical tissue. Additionally or alternatively, negative pressure and / or vacuum can be connected to the internal channel 1935 and port 1940 via the internal channel coupling 1945. Negative pressure and / or vacuum can expel substances (e.g., blood, vaginal secretions, bacteria, saline solution for irrigation, etc.) from the cervix and / or be used to engage or fix the cervix in place.

[0315] Figure 72A provides a top view of a three-port valve housing 2000, and Figure 72B provides a bottom view of the three-port valve housing 2000, which can be used with system 1900 and includes a base 2010 and a hinged or foldable cover 2040. As shown in Figure 72A, a first side or top side of the base 2010 includes a first port 2015, a second port 2020, and a third port 2025, and the cover 2040 includes a first recess 2016, which is sized, positioned, and configured to cover the first port 2015 when the cover 2040 is folded onto the base 2010. The cover 2040 also includes a second recess 2021 and a third recess 2026. The second recess 2021 is sized, positioned, and configured to cover the second port 2020 when the cover 2040 is folded onto the base 2010. The third recess 2026 is sized, positioned, and configured to cover the third port 2025 when the cover 2040 is folded onto the base 2010. As can be seen from FIG. 72A, the second side or bottom side of the base 2010 includes a first cavity coupling portion 2045. The first cavity coupling portion 2045 is sized, shaped, and configured to be inserted into and / or mate with the first cavity 2065 of the three-cavity conduit 2060 (FIG. 73 shows a cross-sectional view of the three-cavity conduit 2060) and communicate with the first port 2015. The base 2010 also includes a second cavity coupling 2050 and a third cavity coupling portion 2055 on its bottom side. The second cavity coupling 2050 is sized, shaped, and constructed to fit into and / or mate with the second cavity 2070 of the three-lumen tube 2060 and communicates with the second port 2020. The third cavity coupling portion 2055 is sized, shaped, and constructed to fit into and / or mate with the third cavity 2075 of the three-lumen tube 2060 and communicates with the third port 2025. For example, when the three-port valve housing is located inside the vagina but is not yet coupled to another device, the cover 2040 can be folded to cover the first port, second port, and third ports 2015, 2020, and 2025 to protect these ports and / or prevent foreign objects from entering them.

[0316] Figure 74A provides an exploded view of the assembly 1901 of the cervical control system 1900, the three-port valve housing 2000, and the three-lumen tube 2060, showing how the three-lumen tube 2060 is arranged between and aligned with the cervical control system 1900 and the three-port valve housing 2000, and how the two are coupled together. Figure 74B shows a close-up view when the three-lumen tube 2060 is aligned with the back side of the three-port valve housing 2000, wherein one end of the three-lumen tube 2060 has a first valve tube coupling extension 2070, a second valve tube coupling extension 2080, and a third valve tube coupling extension 2087. The first valve tube coupling extension 2070 is sized and configured to be inserted into and / or mate with the first lumen coupling extension 2045, the second valve tube coupling extension 2080 is sized and configured to be inserted into and / or mate with the second lumen coupling extension 2050, and the third valve tube coupling extension 2087 is sized and configured to be inserted into and / or mate with the third lumen coupling extension 2055. Figure 74C provides a bottom perspective close-up view of the cervical control system 1900 and the three-lumen tube 2060, wherein the fourth coupling extension 2090 of the three-lumen tube 2060 is coupled to the inner sheath port 1920, the fifth coupling extension 2092 of the three-lumen tube 2060 is coupled to the positioning balloon inflation port 1930, and the sixth coupling extension 2094 of the three-lumen tube 2060 is coupled to the internal channel coupling port 1945.

[0317] In some embodiments, the cervical control system 1900, the three-port valve housing 2000, and the three-lumen tube 2060 may be further coupled to one or more valves (e.g., check valves, duckbill valves, dome valves, and / or combination valves). For example, Figure 75A shows an exploded side view, while Figure 75B shows an exploded perspective view, illustrating the assembly 1901 of the cervical control system 1900, the three-port valve housing 2000, and the three-lumen tube 2060, as well as two check valves 2110 (only one shown) (e.g., a Halkey Roberts check valve) and / or one or more duckbill valves 2215. As shown in Figure 75B, a first check valve 2110A is inserted into a first port 2015, a second check valve 2110B is inserted into a second port 2020, and a duckbill valve 2215 is inserted into a third port 2025. Figure 75B provides a rear perspective view of component 1901 fully assembled, with a first check valve 2110A inserted into first port 2015, a second check valve 2110B inserted into second port 2020, and a duckbill valve 2215 inserted into third port 2025. The first and second check valves 2110A and 2110B can be configured to allow liquid or gas into their respective cavities and inflation medium conduits, and to maintain their pressure after the inner bladder 1905 and positioning balloon have completed inflation. The duckbill valve 2215 can be configured to accept fluid and / or gas insertion into the third cavity 2075 for communication with the internal passage 1935.

[0318] In some embodiments, component 1901 may be further coupled to micropump assembly 2120 and reservoir 2155 configured to contain a volume of substance (e.g., medication, saline solution, alcohol, gas, etc.), as shown in FIG76A. This substance is pumped into third chamber 2075 and circulated within internal channel 1935, allowing it to be discharged from one or more of a plurality of ports 1940. In these embodiments, extension 2160 of reservoir 2155 may be inserted into a corresponding opening 2150 in the body 2125 of micropump assembly 2120 until the extension 2160 is fully contained therein, as shown in FIG76C, which provides a perspective view of reservoir 2155 within micropump assembly 2120 and a three-port valve housing 2000 engaged with micropump assembly 2120. Figures 76A and 76B also illustrate how the protrusion or nozzle 2140 of the micropump assembly is inserted into the duckbill valve 2215, and how the first check valve 2110A and the second check valve 2110B can be aligned with the corresponding first opening 2130 and second opening 2135, respectively, such that the first check valve 2110A and the second check valve 2110B can be inserted therein as shown in Figure 76C. The first opening 2130 and the second opening 2135 can be located within the base 2145 and can be configured to close the first check valve 2110A and the second check valve 2110B, respectively, to prevent, for example, unwanted check valve activation and / or unwanted substance entry. In some embodiments, the first check valve 2110A and / or the second check valve 2110B can be closed by mechanical engagement (e.g., friction engagement) by the corresponding first opening 2130 and / or second opening 2135.

[0319] The micropump assembly 2120 can be configured to pump liquid and / or gas contained in reservoir 2155 from reservoir 2155 via nozzle 2140 into duckbill valve 2215, and then into third chamber 2075, thereby communicating with channel 1935 and cervical tissue via one or more of a plurality of ports 1940 to provide, for example, quantitative, periodic, on-demand and / or continuous administration of the substance contained in reservoir 2155 over a period of time. In some embodiments, reservoir 2155 may contain a volume of vaginal progesterone, which can be pumped from reservoir 2155 to channel 1935 to provide quantitative, periodic, on-demand and / or continuous administration of vaginal progesterone while the cervical control system and pump are held in the patient's vagina.

[0320] In some embodiments, the micropump assembly 2155 may be coated with a biocompatible and flexible material (not shown), such as, but not limited to, silicone, to reduce discomfort that may occur when the micropump assembly 2120 and reservoir 2155 remain in place in the vaginal canal during use. After the dosing regimen is completed in system 1900, the clinician may refill or replace the reservoir 2155 or remove the micropump assembly 2120 together and close the cap 2040 onto the three-port valve housing 2000.

[0321] In some embodiments, channel 1935, third port 1945, and / or third cavity 2075 may include and / or be filled with and / or include a light-guiding material (e.g., optical fiber cable and / or silicone with a refractive index greater than 1.4). The light-guiding material may be configured and / or selected to allow ultraviolet light to pass through for the purpose of eliminating or mitigating localized bacterial colonization.

[0322] Figure 77 provides a side view of an exemplary assembly 1902 including a syringe 1380 containing a volume of fluid in its barrel 1382. The needle 1386 of the syringe 1380 is inserted into a duckbill valve 2215, allowing the volume of fluid contained in the barrel 1382 to be pushed into a third chamber 2075, thereby establishing communication with channels 1935 and ports 1940 by pressing a plunger 1388 into the barrel 1382.

[0323] Figures 78A-78J illustrate various views of mold parts and mold assemblies that can be used to manufacture, mold, and / or process one or more cervical control systems described herein. Specifically, Figure 78A is a bottom view of the top mold 7801, Figure 78B is a bottom view of the waist mold 7802, Figure 78C is a top view of the waist mold 7802, Figure 78D is a cross-sectional view of the top mold 7801 taken along the bisection line 78D of Figure 78A, Figure 78E is a cross-sectional view of the waist mold 7802 taken along the bisection line 78E of Figure 78B, Figure 78F is a top view of the bottom mold 7803, Figure 78G is a cross-sectional view of the bottom mold 7803 taken along the bisection line 78G of Figure 78F, and Figure 78H shows the top mold 7801, the waist mold 7802, and the bottom mold 7801. Figure 781 is an exploded perspective view of component 7805 of the cervical control system 7700; Figure 78J is a bisection view of the exploded component 7805 of the cervical control system 7700; Figure 78K is a bisection view of the cervical control system 7700; Figure 78L is an oblique section view of the cervical control system 7700; and Figure 78M is a bisection view of the cervical control system 7701, which is a cervical control system 7700 having a fully assembled inner sheath (i.e., the flanges of the flexible membrane constituting the inner sheath are inserted and engaged in corresponding slots in the system body). All directional reference terms (e.g., top, bottom, upper, lower, etc.) used in the following discussion of Figures 78A-78M are relative to the directions shown in Figures 78H-78J. The term "distal" refers to the side of the system opposite the inner sac and is typically configured for use near the uterine fornix (facing the uterus); the term "proximal" typically refers to the side of the system away from the uterus when in situ.

[0324] The top of the mold 7801, the waist of the mold 7802, and / or the bottom of the mold 7803 may be aligned and / or pressed together to manufacture one or more cervical control systems disclosed herein using any suitable means, tools, mechanisms, and / or systems (including, but not limited to, locating pins, alignment holes, alignment slots, alignment extensions, clamps, presses, alignment blocks, etc.). Materials (e.g., silicone) may be injected or otherwise (e.g., pressed) added to the top of the mold 7801, the waist of the mold 7802, and / or the bottom of the mold 7803, or used in conjunction with the top of the mold 7801, the waist of the mold 7802, and / or the bottom of the mold 7803, to manufacture one or more cervical control systems disclosed herein.

[0325] As can be seen from the bottom view and cross-sectional view of the mold top 7801 provided by Figures 78A and 78D respectively, the mold top 7801 includes a proximal opening extension 7872, the size, construction, and position of which are adapted to mold or manufacture a proximal opening of a cervical control system (similar to the proximal opening disclosed herein). The top mold 7801 also includes a pair of upper recessed portion notches 7810A, the size, construction, and position of which are adapted to mold or manufacture the upper surface of a recessed portion of a flexible membrane (similar to the recessed portion disclosed herein). The mold top 7801 also includes a plurality of wedge notches 7816, the size, construction, and position of which are adapted to mold or manufacture corresponding plurality of wedges (similar to the wedges disclosed herein) extending from the outer surface of the flexible membrane of the inner sheath. The top of the mold 7801 also includes an inclined plane 7806, the size, construction, and position of which are adapted to mold or manufacture the upper surface of the flexible membrane of the inner sheath (similar to the flexible membrane and inner sheath disclosed herein). The top of the mold 7801 also includes an extending notch 7804, the size, construction, and position of which are configured to mold or manufacture the upper surface of a recess extending from the outer periphery of the flexible membrane of the inner sheath.

[0326] As shown in Figures 78B, 78C, and 78E, the mold waist 7802 includes a mold waist base 7828, a central hole 7836, and a pair of lower recessed portion notches 7810B. The size, structure, and position of the central hole 7836 allow for the creation of an internal channel by inserting an internal channel extension 7842 provided by the bottom mold 7803 (see, for example, Figures 78F and 78G). The size, structure, and position of the lower recessed portion notches 7810B are adapted to mold or manufacture the lower surface of a recessed portion of a flexible membrane (such as the recessed portion disclosed herein). The mold waist 7801 also includes a flexible membrane surface 7834, the size and configuration of which are arranged close to an inclined plane 7806 of the top mold 7801 (see, for example, Figure 78H), such that the negative space between the top mold 7801 and the waist mold 7802 forms the flexible membrane of the inner sheath, the inner cavity of the inner sheath, and the flexible membrane extension. The mold waist 7801 also includes a lower extension recess 7822, which is sized, constructed, and positioned to mate with an extension recess 7804 to form the underside of an extension of a flexible membrane configured to fit into a recess of a cervical control system formed by a recess extension 7844 (see, for example, FIG. 78H). The molded waist 7802 also includes a positioning balloon recess 7878, which is sized, constructed, and positioned to form a molded recess into which the flexible membrane of the positioning balloon can be attached (for example, as shown in FIG. 59 and / or FIG. 69G). The mold waist 7902 also includes a fluid conduit structure 7832 configured to mate with a fluid conduit extension 7864 of the bottom mold 7803 to form a cavity for one or more fluid conduits (such as those disclosed herein). As can be seen in the cross-section of Figure 78E, the flexible membrane surface 7834 can be covered with and include material for creating an inner lumen (similar to the lumen disclosed herein) for the inner sheath.

[0327] Figure 78F shows a top view of the bottom mold 7803, and Figure 78G shows a cross-sectional view of the bottom mold 7803. The bottom mold 7803 includes a bottom mold base 7852 with an internal channel extension 7842, the internal channel extension 7842 having a wedge-shaped protrusion 7856 and a recessed protrusion 7854 extending therefrom. The size, position, and construction of the wedge-shaped protrusion 7856 can mate with a wedge-shaped recess 7816 of the top mold 7801 to form a wedge extending from the outer surface of the flexible membrane of the inner sheath (similar to the wedge, flexible membrane, and inner sheath disclosed herein). The size, position, and construction of the recessed protrusion 7854 can mate with an upper recessed recess 7810A and a lower recessed recess 7810B to form a recessed portion of the inner sheath of the cervical control system (similar to the recessed portion of the inner sheath disclosed herein). The bottom mold base 7852 also includes a distal edge recess 7846 of the cervical control system, the size, location, and configuration of which are adapted to form the lower edge or distal edge of the cervical control system (similar to the cervical control system disclosed herein). Furthermore, the bottom mold base 7852 has a curved recess 7848, the size, location, and configuration of which are configured to form the lower edge or distal edge of a flexible membrane (which forms an inner sheath similar to the inner sheath disclosed herein).

[0328] When molding or manufacturing a cervical control system similar to the cervical control system disclosed herein, a bottom mold 7803 can be placed on a surface, and a mold waist 7802 can be aligned with the bottom mold 7803 before use. Then, a mold top 7801 can be aligned with and fitted onto the mold waist 7802. The mold top, mold waist, and mold bottom 7801, 7802, and 7803 can be pressed (e.g., clamped) together or otherwise assembled to reduce and / or eliminate the possibility of movement between mold components. Figure 78H shows a cross-sectional view of an exemplary assembly 7805 of the top mold 7801, mold waist 7802, and bottom mold 7803, wherein the negative space between the top mold 7801, mold waist 7802, or bottom mold 7803 (i.e., the space not occupied by the top mold 7801, mold waist 7802, or bottom mold 7803) can define the shape and configuration of the molded cervical control system (such as the cervical control system disclosed herein).

[0329] Next, materials used to manufacture the cervical control system (such as silicone, plastic, etc.) can be injected into a mold assembly (e.g., mold assembly 7805) to form the cervical control system (similar to the cervical control system disclosed herein). Once the material has cured, the mold assembly can be disassembled, thereby releasing the molded cervical control system. Figure 78I shows an exploded perspective view of assembly 7805, and Figure 78J shows a cross-sectional view of assembly 7805 after the cervical control system 7700 has been molded therein. Using assembly 7805, the cervical control system can be molded essentially as a single piece, except for attaching a flexible membrane to form a positioning balloon. This simplifies the manufacturing process and reduces the number of connection points for additional parts, thereby improving durability and performance while reducing manufacturing costs.

[0330] Figures 78K and 78L show cross-sections and sectional views of the cervical control system 7700 (also referred to herein as system 7700) after it has been removed from assembly 7805 before the inner sheath 7708 is attached. System 7700 includes many components of the cervical control system disclosed herein, including a body 7702, a distal opening 7706, an internal channel 7770, a flexible membrane 7713, and a plurality of wedges 7716. The flexible membrane 7713 also includes a notch 7715 formed by a positioning balloon recess 7878, the notch 7715 being positioned on the outer surface of the body 7702 and configured to receive the flexible membrane (not shown) of the positioning balloon, which may be coupled as shown in Figures 59 and / or 69G.

[0331] System 7700 also includes an opening region 7755, the size, shape, and configuration of which are designed to provide a lumen 7756 for the system once the extension 7752 is positioned within and / or engaged within the recess 7750, thereby forming a fully assembled inner sheath 7708 of the cervical control system 7701, as shown in the cross-sectional view of FIG78M. The inner sheath 7708 also includes a recessed portion 7710 and an expandable portion 7712, which can be constructed and / or function in a manner similar to the inner sheath recessed and expandable portions disclosed herein.

[0332] Figure 79 illustrates a flowchart of an exemplary procedure 7900 for determining whether and / or how to insert and / or use a cervical control system similar to those disclosed herein for a patient, and / or to facilitate, for example, the regeneration and / or restoration of the cervical mucus plug, prevent preterm birth and / or delivery, prolong fetal pregnancy, and / or treat short cervix, PROM, PPROM, pregnancy complications, and / or pelvic organ and / or tissue prolapse. Procedure 7900 can be performed by, for example, a clinician, care provider, physician, surgeon, nurse, or other technician providing medical care to the patient. In some embodiments, one or more steps of procedure 7900 may be performed by a computer or software running on a computer and / or database (e.g., an electronic medical record database) and / or with the assistance of a computer or software. Procedure 7900 will be discussed concurrently with the accompanying drawings (e.g., Figures 80-80L illustrate how the various steps in the procedure are performed and / or their results).

[0333] In step 7905, information about the pregnant patient may optionally be received. This information may include, for example, the patient's laboratory test results, the patient's medical history, images of the patient's anatomy from which cervical length and / or dilation can be determined (e.g., ultrasound images of the pelvis and / or uterus), visual examination of the patient's anatomy (e.g., the vagina and / or cervix), and / or manual examination of the patient's anatomy. Exemplary laboratory test results include, but are not limited to, hormone levels (e.g., estrogen, progesterone, oxytocin, etc.) and / or fetal fibronectin (fFN) levels (e.g., present in cervical vaginal fluid). Exemplary medical history information that may be received includes, but is not limited to, age, number of fetuses present in the patient's uterus (e.g., singleton, twins, triplets, etc.), history of preterm birth in the patient and / or her family, history of pregnancy complications in the patient and / or her family, history of short cervix, PROM and / or PPROM in the patient and / or her family, whether the patient has undergone cervical surgery (e.g., surgery, cerclage, electrosurgical excision procedure (LEEP)), and / or whether the patient has one or more factors that lead to pregnancy complications and / or high-risk pregnancy (e.g., advanced age, chronic inflammation, diabetes, and / or hypertension). Exemplary examination information that may be received and / or determined by performing step 7905 includes, but is not limited to, a PROM and / or PPROM diagnosis, and / or a specific length of the cervix (e.g., a shortened cervix), which may be less than 25 mm, and / or within a length range including 17-39 mm, 15-40 mm, or 10-45 mm.

[0334] When step 7905 is performed, it can be determined in step 7910 (based on some or all of the information received and / or determined in step 7905) whether the pregnant patient is at risk of preterm birth, pregnancy complications, pelvic complications (e.g., prolapse) and / or has indications for preterm birth, pregnancy complications, pelvic complications (e.g., prolapse), and / or is a suitable candidate for the use of a cervical control system similar to the cervical control system disclosed herein. If not, process 7900 can proceed to step 7915, and the patient can be monitored periodically, continuously, and / or on demand to, for example, reassess whether the use of the cervical control system is beneficial to the patient (e.g., step 7910 can be repeated).

[0335] When, in step 7910, it is determined or otherwise (e.g., by a clinician when steps 7905 and / or 7910 are not performed) that a pregnant patient is at risk of preterm birth and / or has indications for preterm birth, pregnancy complications, pelvic complications (e.g., prolapse), and / or is otherwise a suitable candidate for the use of a cervical control system, the execution of procedure 7900 may proceed to (or initially begin at) step 7920, in which a speculum may be inserted into the patient's vagina for visual observation, measurement, and / or manual examination of the cervix to, for example, assess cervical dilation, Flattening, integrity, adequacy, length, structural integrity; Figure 80A shows a sagittal view of an exemplary patient 8000, showing the patient's vaginal canal 1992, vaginal opening (vaginal orifice) 1994, short cervix 1996, and external os (distal opening of the cervix) 1998, and Figure 80B shows a sagittal view of patient 8000, showing a speculum located within the vaginal cavity 1992 (as may occur during the execution of step 7920), so that, for example, the cervix 1996 can be visually observed and / or swabbed to obtain a sample for laboratory testing. After the speculum is inserted, the cervix can be manually examined, for example, to assess the dilation, integrity, length, and / or flattening of the cervix.

[0336] When the cervix (e.g., cervix 1996) is easily accessible and / or has structural integrity (as determined in step 7925), the speculum can be removed from the vagina, and a cervical control system (e.g., the cervical control system disclosed herein) can be manually inserted into the vagina (e.g., vagina 1992) and, for example, fitted around the cervix (e.g., cervix 1996) by inserting the cervix into the internal channel of the cervical control system (as described herein) (step 7935). An example of performing step 7935 is shown in Figure 80C, which illustrates a clinician's hand manually inserting the cervical control system by performing step 7025.

[0337] Alternatively, in step 7925, if the clinician determines that the cervix is ​​difficult to access and exhibits a high degree of flexibility, a potentially better / more effective approach might be to first stabilize the cervix using a cervical stabilization system (e.g., forceps) before placing the cervical control system and / or using the cervical stabilization system to pull the cervix through, for example, the internal channel of the cervical control system as shown in Figure 80D (step 7930). Step 7930 can be performed after the speculum inserted in step 7920 has been removed.

[0338] After performing step 7930 or step 7935, once the cervical control system is in place around the cervix, in step 7940, the clinician can reinsert the speculum as shown in Figure 80E and inflate the inner sac (step 7945) as shown in Figure 80F with an inflating medium (e.g., saline). Figure 80F shows that the inner sac can be inflated downwards or extended so that the inflating of the inner sac pulls the cervix downwards and / or does not push the uterus upwards, which would otherwise push the uterus upwards and could cause the cervix to be pulled out of the inner sac 1908 or the entire system.

[0339] Once the inner balloon is fully inflated (step 7945), the positioning balloon of the cervical control system can be inflated with an inflating medium (e.g., saline) (step 7950) to position the positioning balloon, the cervical control system, and / or the cervix as needed, an example of which is shown in Figure 80G. As shown in Figure 80G, the positioning balloon can tilt the cervix at a certain angle by inflating it, thereby, for example, reducing the pressure exerted on it by the uterus. Figure 80G also shows the positioning of the cervix before tilting with dashed line 2032 and the positioning of the cervix after tilting with dashed line 2034. As indicated by the arrows in Figure 80G, the cervix can be tilted further posteriorly after the positioning balloon is inflated. Figure 80G also shows a system with the positioning balloon located posteriorly. In this orientation, by inflating the positioning balloon, the cervical control system can push the top of the posterior portion of the cervix, thereby displacing the rest of the cervix posteriorly as shown in Figure 80G. This can be achieved by pressing the top of the posterior side of the cervix, or in other cases, by rotating the system 180 degrees and pressing the lower part of the anterior side of the cervix (to tilt the cervix posteriorly). Although Figure 80G shows a system with the positioning balloon positioned posteriorly, the positioning balloon 1918 can be positioned in any orientation to tilt the cervix, thereby providing optimal support for the cervix and / or based on the physician's judgment. In the next step 7955, the clinician can remove the speculum and confirm placement by manual examination, and then insert the valve housing 1960 (similar to the valve and valve housing 1360 described with reference to Figures 58-63) into the vagina, for example, as shown in Figure 80H (step 7960).

[0340] In some embodiments, the cervical control system can be positioned by performing some or all of the steps of process 7900 to treat and / or alleviate symptoms associated with prolapse, such as pelvic organ prolapse (e.g., uterine prolapse). In these cases, the cervical control system disclosed herein can be used to treat symptoms of prolapse, including but not limited to bleeding, pressure, pain, incontinence (e.g., urinary incontinence). This invention can be used to treat these symptoms even if the patient does not have an underlying condition of pelvic organ prolapse. As an example, Figure 80I shows a sagittal view of patient 8001, wherein the cervical control system 2200 is positioned around the patient's cervix and used to support uterine prolapse. System 2200 can be similar to, for example, systems 100, 500, 1000, 1100, 1300, 1400, 1500, 1600, and 1700 as described above and shown in Figures 1-6, 19-20, 36-37, 51-54, 58-59, 64A-64B, 65A-65B, 66, 67A-67C, and 68A-68B. Similar to the components of the aforementioned systems 100, 500, 1000, 1100, 1300, 1400, 1500, 1600, and 1700, system 2200 of Figure 80I includes a body 2202, a proximal opening 2204, a distal opening 2206, and an inflatable positioning balloon 2218. As shown in Figure 80I, compared to the orientation described with reference to Figures 1-6, 19-20, 36-37, 51-54, 58-59, 64A-64B, 65A-65B, 66, 67A-67C, and 68A-68B, system 2200 can be placed in an inverted orientation. This inverted orientation orients system 2200 so that the cervix can be cupped within the larger distal opening 2206 of system 2200 and closed by the inflation of the inner sheath of the cervical control system. The distal opening may have a cushioning layer (such as silicone) to increase surface area contact and provide greater user comfort. As shown in Figure 80I, the positioning balloon 2218 can be placed in an anterior position. However, the positioning balloon 2218 can be placed in any orientation that best supports the uterus. Once the cervical control system is placed in the patient, the clinician or user can inflate the positioning balloon 2218 to provide mechanical support to the uterus, thereby treating uterine prolapse. In some cases, the positioning balloon 2218 can be deflated before removal. The system 2200 can provide structurally semi-rigid support while also providing an inflatable portion (e.g., the positioning balloon) to accommodate anatomical differences. When used to treat and / or relieve prolapse symptoms, steps 7905-7960 can be performed; however, in some cases, the inner balloon may not be inflated (step 7945).

[0341] Additionally or alternatively, procedure 7900 and / or its steps may be performed to mitigate and / or treat the effects of PPROM or PROM. In these cases, positioning the cervical control system around the patient's cervix can help close the cervix and prevent further leakage or seepage of amniotic fluid from the ruptured amniotic sac.

[0342] Figure 80J shows a sagittal view of a pregnant patient, showing an intact membrane 1802 filled with normal or clinically acceptable levels of amniotic fluid 1804. Figure 80K shows a sagittal view of a pregnant patient with PPROM and a ruptured membrane 1802 and low levels of amniotic fluid 1804 due to leakage of amniotic fluid from the ruptured membrane 180. Figure 80L shows a sagittal view of a pregnant woman whose cervix 101 is located within and compressed by a cervical control system 1800, which may be similar to one or more cervical control systems described herein. The cervical control system 1800 can be placed in the patient by performing one or more steps of process 7900. Compression of the cervix 101 can act to stop or reduce the flow rate of amniotic fluid leakage from the ruptured membrane 1802, thereby allowing the amniotic fluid in the ruptured membrane 1802 to be replenished. In some embodiments, the body of one or more cervical control systems disclosed herein may be a partially cubic shape, a pyramid shape, a partially oval shape with an elliptical or partially elliptical cross section, an irregular three-dimensional shape with an asymmetrical cross section, or any other shape suitable for surrounding the cervix and engaging the vaginal wall.

[0343] In some cases, multilayer materials (e.g., multilayer silicone) can be used to create proximal and / or positioning balloons and / or cervical control systems and / or the devices themselves. For example, embodiments such as those shown in Figures 26-27 can utilize multilayer materials (e.g., silicone) for bonding. In this case, a plasma bonding process can be used to couple these material layers. For example, plasma can be applied to alter the surface energy / chemical properties of the material to promote adhesion to fully cured silicone. In other cases, silicone adhesives can be used. In some situations, adhesives may pose a risk of clogging the inflation channel and may result in poor sealing performance. Therefore, in some cases, a plasma bonding process can be used without adhesives and / or other adhesives, or with a limited amount of adhesives and / or other adhesives. In some embodiments, one, two, three, or more layers are used, and a plasma bonding process can be used to bond these layers.

[0344] In some embodiments, various components and functions of the cervical control system described and illustrated herein can be adapted to any other embodiments disclosed herein. Therefore, the cervical control systems of the various exemplary embodiments detailed above provide selectively adjustable cervical control systems for controlling and / or supporting cervical insufficiency, mitigating amniotic fluid leakage due to rupture of the amniotic sac, promoting the growth and / or regeneration of the cervical mucus plug, and / or supporting pelvic organs to, for example, promote prolonged pregnancy in preterm pregnancies, reduce pregnancy complications, and improve patient (maternal and infant) outcomes. The cervical control system includes an upper or inner sac for supporting, elongating, and / or contracting the patient's cervix in an attempt to prevent further dilation, opening, or shortening of the cervix.

[0345] The inner cuff disclosed herein may include a flexible membrane of fixed or variable width defining one or more lumens that open to and / or are configured to receive an inflation medium therein. When an inflation medium is inserted into and / or pushed into the lumen of the inner cuff, the corresponding flexible membrane of the inner cuff may expand in size to, for example, engage and / or contract the cervix located therein. The expansion of the flexible membrane / inner cuff may be radial and / or distal. In some cases, the inner cuff disclosed herein may include multiple independently controllable (e.g., inflatable or deflate) inflatable pouches to provide customizable support for the cervix according to the patient's specific needs. In a preferred embodiment, the inner cuff disclosed herein provides lateral and downward forces (e.g., away from the uterus) to the cervix, which may promote cervical retention within the inner cuff, cervical elongation, and / or cervical compression (which may reverse and / or prevent cervical dilation). In some embodiments, the shape and size of the inner cuff allow blood to flow from the upper cervix through the inner cuff to the lower cervix.

[0346] The cervical control system disclosed herein may include a lower portion or positioning balloon of the cervical control system herein, which may be provided to position or secure the main body of the respective cervical control system to the patient's vaginal wall during use. The positioning balloon may include one or more inflatable pouches that can be independently controlled to provide customizable support and / or control of the cervix.

[0347] This document also discloses kits that include one or more cervical control systems described herein. Figure 81 shows a block diagram of contents for an exemplary kit 8100 having exemplary components, parts, devices, and / or apparatuses, including but not limited to one or more cervical control systems and / or systems 8105 (such as the cervical control systems disclosed herein), an inflation medium container 8110, an inflation medium delivery device 8115, one or more cervical stabilizing devices 8120, one or more measuring devices 8125, one or more valve housings 8130, one or more tubes and / or catheters 8135, a speculum 8140, and a lubricant container 8140. It should be noted that not all embodiments of the kit 8100 include all the components, parts, devices, and / or apparatuses shown in Figure 81.

[0348] In some embodiments, kit 8100 may include multiple different cervical control systems with different characteristics, which may be customized for certain conditions and / or patient anatomy. For example, cervical control devices and / or systems 8105 may include small, medium, and large cervical control systems. Additionally or alternatively, cervical control devices and / or systems 8105 may include cervical control systems suitable for treating PPROM and cervical control systems suitable for treating short cervixes. Additionally or alternatively, cervical control devices and / or systems 8105 may include cervical control systems with different features of the inner sheath and / or positioning balloon (e.g., wedge size, number, and / or type, etc.).

[0349] In some embodiments, the expansion medium delivery device may be a pump or syringe, and in some cases, the expansion medium delivery device may be pre-filled with expansion medium. In these cases, kit 8100 may not include expansion medium container 8110. Exemplary cervical stabilization device 8120 includes, but is not limited to, forceps and hooks. Exemplary measuring device 8125 may be configured to measure the length or dilation of the cervix and includes, but is not limited to, a ruler. In some cases, tubes and / or catheters 8135 may include tubes and / or catheters of different lengths, such that, for example, a clinician can select a particular length of tube, for example, when the cervical control system is in situ, the tube can be easily accessed at the end of the tube / catheter extending from the vaginal opening. In this way, the selected tube and / or catheter can be adapted to the patient's anatomy and / or the clinician's preferences. In some embodiments, the tube and / or catheter 8135 may include a tube and / or catheter having one, two, three, or four lumens, and the type of the selected tube and / or catheter 8135 may be responsive to the type of the selected cervical control system and / or system 8105 and / or the number of fluid conduits and / or inlets that the selected cervical control system and / or system 8105 has. The valve housing 8130 may be any valve housing disclosed herein, and in some cases, the kit 8100 may provide multiple valve housings such that the valve housing 8130 used may be responsive to and / or configured to cooperate with the selected tube and / or catheter 8135 or cervical control system and / or system 8105.

[0350] The lubricant container 8140 can hold any suitable lubricating material that can make it easier and / or more comfortable for the patient to use one or more parts of the kit 8100. In some cases, the lubricant may include active agents, such as antimicrobial agents and / or pharmacologically active agents.

[0351] Changes and modifications may be made to the specifically described embodiments without departing from the principles of this disclosure. The various aspects and examples disclosed herein can be considered individually or in conjunction with other aspects, examples, and variations of this disclosure. Furthermore, unless otherwise specified, the method steps of this disclosure are not limited to any particular order of execution.

[0352] While the methods, apparatuses, and systems described herein may be readily modified and substituted in various ways, specific examples have been shown in the accompanying drawings and described in detail herein. However, it should be understood that these embodiments are not limited to the particular forms or methods disclosed herein, but are intended to cover modifications, equivalents, and alternatives falling within the spirit and scope of the various examples and embodiments described herein and the appended claims. Furthermore, any particular feature, aspect, method, property, characteristic, quality, attribute, element, or similar content disclosed herein, when described in conjunction with an example, can be applied to all other examples listed herein. No method steps disclosed herein need to be performed in the listed order. The use of sequential or temporal language such as “then,” “following,” “after,” “subsequently,” etc., unless expressly stated otherwise or understood from the context, is generally for ease of writing and is not intended to limit the order of operations. Therefore, in some instances, operations may be performed in the order described herein, while in other instances, they may be performed in a different order.

[0353] The conditional language used herein, such as “can,” “may,” “can,” “for example,” etc., unless expressly stated otherwise or understood from the context, is generally intended to indicate that certain embodiments include specific features, elements, and / or states, while others do not. Therefore, such conditional language generally does not imply that these features, elements, modules, and / or states are necessary in one or more embodiments, or that one or more embodiments necessarily include logic (whether or not dependent on user input or prompts) for determining whether to include these features, elements, and / or states, or whether to perform them in any particular embodiment. When an apparatus, system, and / or method “comprises” certain features or steps, if so defined in the claims, such apparatus, system, and / or method may also be “substantially constituted” by those features or steps.

[0354] The methods disclosed herein may include certain actions performed by practitioners; however, these methods also include instructions to these actions by any user or third party, whether explicit or implicit. For example, an action such as “locating a device” includes “instructing a locating device.”

[0355] The numerical ranges disclosed herein also encompass all overlapping ranges, subranges, and combinations thereof. Terms such as “at most,” “at least,” “greater than,” “less than,” and “between” include the listed numerical values. When words such as “about” or “approximately” are used before a numerical value, they should be understood to include the stated value and should be interpreted according to the specific context (e.g., reasonable accuracy, such as ±5%, ±10%, ±15%, etc.). For example, “about 4 inches” includes “4 inches.” When words such as “substantially” are used before a phrase, they should be understood to include the stated phrase and should be interpreted according to the specific context (e.g., as close as reasonably possible). For example, “substantially linear” includes “linear.” Unless otherwise stated, all measurements are performed under standard conditions, including temperature and pressure.

[0356] The phrase "at least one" is intended to require at least one item in the subsequent list, rather than a type of each item in each of the subsequent lists. For example, "at least one of A, B, and C" could include A; B; C; A and B; A and C; B and C; or A, B, and C.

Claims

1. A cervical control system comprising: a body configured for insertion into a patient's vagina such that an internal passage of the body can accept insertion of a patient's cervix, the body comprising: an internal passage configured for receiving a patient's cervix therein; an inflation media conduit disposed within a sidewall of the body, a first end of the inflation media conduit opening to and configured to be in fluid communication with an internal lumen defined by a flexible membrane of an internal cuff of the cervical control system, and a second end of the inflation media conduit comprising an inlet configured to receive fluid for communication with the internal lumen of the internal cuff via the first end of the inflation media conduit; an internal cuff comprising: a flexible membrane defining an internal lumen therein, the flexible membrane configured to expand upon addition of inflation media to the internal lumen via the first end of the inflation media conduit.

2. The cervical control system of claim 1, wherein the flexible membrane expands in a direction radially inward toward the internal passage such that an outer surface of the internal cuff contacts and compresses the cervix positioned within the internal passage.

3. The cervical control system of claim 1 or 2, wherein the flexible membrane expands in a distal direction to further draw the cervix into the internal passage.

4. The cervical control system of claim 1, 2, or 3, wherein expansion of the flexible membrane causes elongation of the cervix positioned within the internal passage.

5. The cervical control system of any of the above claims, wherein expansion of the flexible membrane adjusts at least one of an orientation angle of the cervix, a degree of dilation of the cervix, and a length of the cervix.

6. The cervical control system of any of the above claims, wherein as a volume of inflation media added to the internal lumen increases, a compressive force exerted on the cervix by the expanded flexible membrane also increases.

7. The cervical control system of any of the above claims, wherein as a volume of inflation media added to the internal lumen increases, an elongation force exerted on the cervix by the expanded flexible membrane also increases.

8. The cervical control system of any of the above claims, wherein expansion of the flexible membrane causes the cervix to flex.

9. The cervical control system of any of the above claims, wherein a thickness of the flexible membrane is uniform throughout the flexible membrane.

10. The cervical control system of any of the above claims, wherein a thickness of the flexible membrane is variable throughout the flexible membrane.

11. The cervical control system of claim 10, wherein a thickness of an apical portion of the flexible membrane is greater than a thickness of a proximal portion of the flexible membrane and a distal portion of the flexible membrane when the internal cuff is in a neutral state.

12. The cervical control system of claim 10 or 11, wherein the thickness of the apical portion of the flexible membrane decreases as the internal cuff expands.

13. The cervical control system according to any of the preceding claims, wherein a length of a proximal portion of the flexible membrane is greater than a length of a distal portion of the flexible membrane when the inner sleeve is in a neutral state.

14. The cervical control system according to claim 11, wherein the flexible membrane expands in a direction away from the patient's uterus due to the length of the proximal portion of the flexible membrane being greater.

15. The cervical control system according to any of the preceding claims, wherein a portion of an outer surface of the inner sleeve is coated with at least one of a drug, an antibacterial agent, a friction increasing agent, and an adhesive.

16. The cervical control system according to any of the preceding claims, wherein the flexible membrane includes a bend configured to assist in expansion of the flexible membrane when the inner lumen is inflated.

17. The cervical control system according to any of the preceding claims, wherein the flexible membrane is further configured to contract when inflation media is withdrawn from the inner lumen.

18. The cervical control system according to claim 17, wherein the degree of expansion or contraction of the flexible membrane is responsive to at least one of: a clinical need, an orientation of the cervix, an orientation of the patient's uterus, a degree of dilation of the cervix, a length of the cervix, a degree of softening of the cervix, and an indication of a patient's amnion membrane status.

19. The cervical control system according to any of the preceding claims, wherein the flexible membrane expands in a direction away from the patient's uterus and radially toward the patient's cervix when inflation media is added to the inner lumen.

20. The cervical control system according to any of the preceding claims, wherein the inner sleeve further comprises: a plurality of flexible membranes, each of the plurality of flexible membranes defining a separate inner lumen therein, the inner lumens being in fluid communication with the inflation media conduit, and configured to expand when inflation media is added to each respective inner lumen.

21. The cervical control system according to any of the preceding claims, wherein the flexible membrane further comprises: a first recessed portion; and a second recessed portion disposed approximately 180 degrees opposite the first recessed portion, wherein the first recessed portion and the second recessed portion expand to a lesser degree than a remainder of the flexible membrane when the inner sleeve is in an inflated state after inflation media is added to the inner lumen.

22. The cervical control system according to claim 21, wherein at least one of the first recessed portion and the second recessed portion is sized and positioned to avoid compressing blood vessels of the cervix located within the inner passage when the inner sleeve is inflated.

23. The cervical control system according to claim 21 or 22, further comprising: one or more wedges on an outer surface of the flexible membrane that does not include the first recessed portion or the second recessed portion, the wedges configured to press into and secure the cervix.

24. The cervical control system according to any of the preceding claims, further comprising: one or more wedges on an outer surface of the flexible membrane, the wedges configured to press into and secure the cervix. ​ 25. The cervical control system of claim 24, wherein the one or more wedges are configured to increase a coefficient of friction between the cervix and the flexible membrane.

26. The cervical control system of claim 24 or 25, wherein the one or more wedges have a semi-circular, rectangular, parallelogram, triangular, oval, trapezoidal, or irregular radial profile.

27. The cervical control system of any one of claims 24 to 26, wherein the one or more wedges have at least one of a semi-circular, rectangular, parallelogram, triangular, oval, trapezoidal, hook-like, curved, and irregular cross-sectional profile.

28. The cervical control system of any one of claims 24 to 27, wherein the one or more wedges have at least one of a semi-circular, rectangular, parallelogram, triangular, oval, trapezoidal, or irregular bump shape.

29. The cervical control system of any one of the preceding claims, further comprising: an array of wedges arranged in multiple rows and extending from an outer surface of the flexible membrane.

30. The cervical control system of any one of the preceding claims, wherein the second end of the inflation medium conduit is attached to a valve.

31. The cervical control system of any one of claims 1 to 29, wherein the second end of the inflation medium conduit is attached to a valve housing.

32. The cervical control system of claim 31, wherein the valve housing comprises a pressure sensor.

33. The cervical control system of claim 31 or 32, wherein the valve housing comprises a cap configured to removably cover the valve.

34. The cervical control system of any one of claims 30 to 33, wherein the valve is at least one of a one-way valve, a duckbill valve, a silicone valve, a check valve, a Halkey Roberts valve, a Luer activated check valve, a check valve with a polycarbonate body, and a check valve.

35. The cervical control system of claim 30, wherein the valve is configured to accept insertion of an inflation medium source into the valve and to transmit inflation medium from the inflation medium source to the inflation medium conduit for communication with the internal cavity.

36. The cervical control system of any one of the preceding claims, wherein the body further comprises a valve configured to be in fluid communication with the second end of the inflation medium conduit.

37. The cervical control system of any one of the preceding claims, wherein the inflation medium conduit extends beyond the body such that the inflation medium conduit is accessible outside of a patient's vaginal opening.

38. The cervical control system of any one of the preceding claims, wherein at least one of the valve and the valve housing is removably attached to the second end of the inflation medium conduit.

39. The cervical control system of claim 38, wherein at least one of the valve and the valve housing is configured to be removed from the second end of the inflation medium conduit after use so as to place the second end of the inflation medium conduit within a patient's vaginal canal.

40. The cervical control system of any of the preceding claims, further comprising: a positioning balloon disposed on an outer surface of the main body, the positioning balloon being inflatable when the inflation medium conduit is positioned in the positioning balloon.

41. The cervical control system of any of the preceding claims, wherein the inflation medium conduit is a first inflation medium conduit and the flexible membrane is a first flexible membrane, the cervical control system further comprising: a second inflation medium conduit disposed within a sidewall of the main body, a first end of the second inflation medium conduit opening to and configured to be in fluid communication with a positioning balloon lumen defined by a flexible membrane of a positioning balloon, and a second end of the second inflation medium conduit comprising an inlet configured to receive inflation medium for communication with the positioning balloon lumen via the first end of the second inflation medium conduit; a positioning balloon, the positioning balloon comprising: a second flexible membrane defining a positioning balloon lumen therein, the second flexible membrane configured to inflate upon injection of inflation medium into the positioning balloon lumen.

42. The cervical control system of claim 40 or 41, wherein the positioning balloon is configured to adjust an orientation of the cervical control system when positioned within a vagina and inflated.

43. The cervical control system of claim 40, 41, or 42, wherein the positioning balloon encircles a portion of an outer surface of the main body.

44. The cervical control system of claim 40, wherein the positioning balloon encircles less than fifty percent of a distal portion of an outer surface of the main body.

45. The cervical control system of any of claims 40 to 44, wherein the positioning balloon is located at a distal end of the main body.

46. The cervical control system of any of claims 40 to 45, wherein the positioning balloon is located on a side of the main body.

47. The cervical control system of any of claims 40 to 46, wherein the positioning balloon is a first positioning balloon located on a side of the main body, the cervical control system further comprising: a second positioning balloon located at a distal end of the main body.

48. The cervical control system of any of claims 40 to 47, wherein the second end of the second inflation medium conduit is attached to a valve.

49. The cervical control system of any of claims 40 to 48, wherein the second end of the second inflation medium conduit is attached to a valve housing.

50. The cervical control system of claim 49, wherein the valve housing comprises a pressure sensor.

51. The cervical control system of claim 49 or 50, wherein the valve housing comprises a cap configured to removably cover the valve.

52. The cervical control system of claim 48, wherein the valve attached to the second end of the second inflation medium conduit is at least one of: a one-way valve, a duckbill valve, a silicone valve, a check valve, a Halkey Roberts valve, a Luer activated check valve, a check valve with a polycarbonate body, and a check valve.

53. The cervical control system according to claim 48 or 52, wherein the valve attached to the second end of the second inflation medium conduit is configured to accept insertion of an inflation medium source into the valve and to transmit inflation medium from the inflation medium source to the second inflation medium conduit for communication with the positioning balloon lumen.

54. The cervical control system according to any of the preceding claims, wherein the second inflation medium conduit extends out of the body such that the second inflation medium conduit can be accessed outside of the patient's vaginal opening.

55. The cervical control system according to any of claims 40 to 54, wherein inflation of the positioning balloon adjusts an orientation angle of the cervix.

56. The cervical control system according to any of the preceding claims, wherein the body has a circular horizontal cross-sectional shape.

57. The cervical control system according to any of the preceding claims, wherein the body has an oval horizontal cross-sectional shape.

58. The cervical control system according to any of the preceding claims, wherein a radial center of the inner sleeve capsule is offset from a radial center of the body.

59. The cervical control system according to any of the preceding claims, wherein the body includes a release notch configured to allow at least one of bending the body and expanding the body.

60. The cervical control system according to any of the preceding claims, wherein the cervical control system further comprises: an annular ring positioned on a proximal edge of the body and proximate a proximal side of the inner sleeve capsule, the annular ring including a tapered edge configured to guide the cervix into the internal passage.

61. The cervical control system according to any of the preceding claims, wherein the cervical control system is integrally molded.

62. The cervical control system according to claim 61, wherein: the flexible membrane is molded to have a first extension that encircles a proximal edge of the flexible membrane and a second extension that encircles a distal edge of the flexible membrane; and the body is molded to have a first recess and a second recess, the first recess being sized, positioned and configured to receive the first extension and the second recess being sized, positioned and configured to receive the second extension, wherein the inner sleeve capsule is formed when the first extension is positioned within the first recess and the second extension is positioned within the second recess.

63. The cervical control system according to any of the preceding claims, further comprising: a liquid delivery device including at least one port configured to allow liquid to seep from the liquid delivery device onto the cervix, the liquid delivery device being positioned adjacent the internal passage and in liquid communication with the conduit.

64. The cervical control system according to claim 63, wherein the liquid includes at least one of a medication, an antiseptic and a hormone.

65. The cervical control system according to claim 63 or 64, wherein the conduit is an inflation medium conduit in communication with the lumen. ​ 66. The cervical control system of claim 63 or 64, wherein the conduit is a liquid delivery conduit positioned within or secured to the body.

67. A cervical control system comprising: a body defining an internal passage for receiving a cervix, the body including an upper portion and a lower portion defining proximal and distal openings, respectively, to the internal passage, and an outer surface for engaging a vaginal wall; and an inner cuff coupled to the body at the proximal opening and configured to surround at least a portion of the cervix, the inner cuff configured to expand from a neutral state to an inflated state in which the inner cuff is configured to engage at least a portion of the cervix; and a positioning balloon disposed at one or both of an outer portion of the body and a lower portion of the body proximate the distal opening, the positioning balloon disposed circumferentially around a portion of the body and configured to expand away from an axial center of the distal opening to expand toward and into the vaginal wall, the positioning balloon expandable from a neutral state to an inflated state in which an outer perimeter of the positioning balloon is increased compared to an outer perimeter of the positioning balloon in the neutral state.

68. The cervical control system of claim 67, wherein the positioning balloon includes a minor arc segment circumferentially disposed around less than 180 degrees of the body.

69. The cervical control system of claim 67, wherein the positioning balloon includes a major arc segment circumferentially disposed around more than 180 degrees of the body.

70. The cervical control system of claim 67, 68, or 69, wherein in the inflated state, a radius of the cervical control system from an axial center of the distal opening to an outer perimeter of the positioning balloon is greater than a radius of the cervical control system from the axial center of the distal opening to an outer perimeter of the body not disposed with the positioning balloon.

71. The cervical control system of any one of claims 67 to 70, wherein the positioning balloon includes a non-uniform wall thickness configured to control expansion of the positioning balloon away from an axial center of the distal opening to expand toward and into the vaginal wall.

72. The cervical control system of claim 70, wherein the positioning balloon includes a first wall thickness proximal of the positioning balloon, a second wall thickness distal of the positioning balloon, and a third wall thickness at an outer perimeter of the positioning balloon, the third wall thickness extending between the first and second walls.

73. The cervical control system of claim 71, wherein the first and second wall thicknesses are substantially the same, and wherein the third wall thickness is greater than the first and second wall thicknesses.

74. The cervical control system of any one of claims 67 to 73, wherein the body includes a hemi-spherical shape, and the proximal opening defines an area that is less than an area defined by the distal opening.

75. The cervical control system according to any of claims 67 to 74, further comprising a wedge disposed along an inner circumference of the inner sleeve, the wedge configured to grip an exterior of a cervix.

76. The cervical control system according to any of claims 67 to 75, wherein the inner sleeve is configured to substantially expand radially inward toward an axial center of the proximal opening when inflated.

77. The cervical control system according to any of claims 67 to 76, wherein the inner sleeve is configured to expand both radially inward and distally away from a transverse plane of the proximal opening and away from the uterus when the inner sleeve is inflated when the inner sleeve is inflated when the inner sleeve is inflated around a cervix.

78. The cervical control system according to claim 76 or 77, wherein the inner sleeve comprises a non-uniform wall thickness.

79. The cervical control system according to claim 77 or 78, wherein the inner sleeve comprises a first wall thickness proximal to the inner sleeve, a second wall thickness distal to the inner sleeve, and a third wall thickness on an inner surface of the inner sleeve, the third wall thickness extending between the first wall and the second wall.

80. The cervical control system according to claim 78 or 79, wherein the first wall thickness and the second wall thickness are substantially the same, and wherein the third wall thickness is greater than the first wall thickness and the second wall thickness.

81. The cervical control system according to claim 78 or 79, wherein the inner sleeve comprises an inner wall configured at an angle relative to an axial center of the proximal opening.

82. The cervical control system according to claim 78 or 79, wherein the inner sleeve comprises an inner wall opposite a wall on an inner surface of the inner sleeve, wherein the inner wall is configured parallel to an axial center of the proximal opening.

83. The cervical control system according to any of claims 67 to 82, wherein the inner sleeve comprises an inflatable portion proximate to a recessed portion, wherein the inflatable portion is selectively extendable further into the internal passage than the recessed portion.

84. The cervical control system according to claim 82 or 83, wherein the inner sleeve comprises a non-uniform wall thickness, wherein the recessed portion has a greater wall thickness than the inflatable portion.

85. The cervical control system according to any of claims 67 to 84, further comprising an inflation media conduit in fluid communication with the first and / or positioning balloon, and a valve in fluid communication with the inflation media conduit opposite the first and / or positioning balloon.

86. The cervical control system according to claim 84 or 85, wherein the valve is operable to detachably receive a portion of an inflation device, the inflation device operable to inflate the first and / or positioning balloon without removal of the device from a patient's vagina.

87. The cervical control system according to claim 82 or 83, wherein the inner sleeve comprises at least two recessed portions and at least two inflatable portions, the inflatable portions alternatingly spaced apart from the recessed portions.

88. The cervical management system of any of claims 67-87, further comprising a pump and a fluid reservoir disposed in the main body, the pump being in fluid communication with the fluid reservoir and the fluid reservoir being in fluid communication with at least one of the inner cuff and the positioning balloon, wherein the pump is adapted to move fluid between the fluid reservoir and at least one inner cuff and positioning balloon for effecting inflation and deflation of the respective inner cuff or positioning balloon.

89. The cervical management system of claim 87 or 88, further comprising a wireless control device for remotely controlling the pump.

90. A cervical management system for placement in a vaginal canal, the cervical management system comprising: a hemispherical main body defining an internal passage for receiving a cervix, the hemispherical main body including an upper portion and a lower portion defining proximal and distal openings, respectively, and an outer surface for engaging a vaginal wall to support the cervical management system proximate the cervix, the hemispherical main body including: an inner cuff coupled to the main body at the proximal opening and configured to surround at least a portion of the cervix; and a positioning balloon disposed at one or both of an outer portion of the main body and a lower portion of the main body proximate the distal opening, the positioning balloon configured to inflate away from an axial center of the distal opening to expand toward and into the vaginal wall, the positioning balloon expanding from a neutral state to an inflated state, an outer perimeter of the positioning balloon in the inflated state being increased compared to an outer perimeter of the positioning balloon in the neutral state; an inflation media conduit including a first end configured to be in fluid communication with the first and / or positioning balloon and a second end opposite the first end; a valve including a first end configured to be in fluid communication with the second end of the inflation media conduit and a second end opposite the first end, the second end configured to receive a portion of an inflation device operable to inflate the first and / or positioning balloon without removal of the cervical management system from the vaginal canal of the patient; and a valve housing including a first end configured to receive the inflation media conduit and a second end including an opening configured to surround the first end of the valve.

91. The cervical management system of claim 90, wherein the valve housing includes a cap configured to removably cover the valve when engaged with the valve housing and configured to allow access to the valve when the cap is removed from the valve housing.

92. The cervical management system of any of claims 90 or 91, wherein the positioning balloon circumferentially surrounds a portion of the main body.

93. The cervical management system of any of claims 90-92, wherein the valve housing includes a pressure gauge configured to provide a tactile and / or visual indication of a pressure within the first and / or positioning balloon.

94. The cervical control system of claim 92 or 93, wherein the pressure gauge comprises a pressure balloon configured to inflate in steps to indicate an amount of pressure increase within the cervical control system.

95. The cervical control system of claim 93 or 94, wherein the pressure balloon comprises a varying wall thickness configured to indicate different pressure levels within the first and / or positioning balloon.

96. A method of supporting and stabilizing a cervix, the method comprising: positioning a cervical control system about a cervix of a patient, the cervical control system comprising: a body defining an internal passage for receiving the cervix, the body comprising an upper portion and a lower portion defining proximal and distal openings, respectively, to the internal passage, and an outer surface for engaging a vaginal wall; an inner cuff coupled to the body at the proximal opening and configured to surround at least a portion of the cervix; and a positioning balloon disposed at one or both of an outer portion of the body and a lower portion of the body proximate the distal opening, wherein the positioning balloon is disposed about a portion of a circumference of the body; inflating the inner cuff to expand the inner cuff from a neutral state to an inflated state in which the inner cuff engages at least a portion of the cervix; inflating the positioning balloon to expand the positioning balloon away from an axial center of the distal opening to expand toward and into the vaginal wall, the positioning balloon expandable from a neutral state to an inflated state in which an outer perimeter of the positioning balloon is increased compared to an outer perimeter of the positioning balloon in the neutral state.

97. The method of claim 96, wherein the cervical control system further comprises an inflation media conduit in fluid communication with the first and / or positioning balloon, and a valve in fluid communication with the inflation media conduit opposite the first and / or positioning balloon.

98. The method of claim 97, further comprising coupling an inflation device to the valve to inflate the first and / or positioning balloon without removing the cervical control system from the vaginal canal of the patient.

99. The method of any one of claims 96 to 98, wherein the positioning balloon comprises a minor arc segment less than 180 degrees circumferentially disposed about the body.

100. The method of any one of claims 96 to 98, wherein the positioning balloon comprises a major arc segment greater than 180 degrees circumferentially disposed about the body.

101. The method of any one of claims 96 to 100, wherein the second cuff comprises a non-uniform wall thickness configured to control expansion of the positioning balloon away from an axial center of the distal opening to expand toward and into the vaginal wall.

102. A method of treating prolapse, the method comprising: positioning a cervical control system about a cervix of a patient, the cervical control system comprising: a body defining an internal passage for receiving a cervix, the body including an upper portion and a lower portion defining proximal and distal openings, respectively, to the internal passage, and an outer surface for engaging a vaginal wall; and a positioning balloon disposed at one or both of an outer portion of the body and a lower portion of the body proximate the distal opening, wherein the positioning balloon is disposed circumferentially around a portion of the body; and inflating the positioning balloon to expand the positioning balloon away from an axial center of the distal opening to expand toward and into the vaginal wall, the positioning balloon being inflatable from a neutral state to an inflated state, an outer perimeter of the positioning balloon in the inflated state being greater than an outer perimeter of the positioning balloon in the neutral state.

103. The method of claim 102, wherein the support system further comprises an inflation media conduit in fluid communication with the positioning balloon, and a valve in fluid communication with the inflation media conduit opposite the positioning balloon.

104. The method of claim 103, further comprising coupling an inflation device to the valve to inflate the positioning balloon without removing the cervical control system from the patient's vagina.

105. The method of any one of claims 102 to 104, wherein the positioning balloon comprises a minor arc segment circumferentially disposed around less than 180 degrees of the body.

106. The method of any one of claims 102 to 105, wherein the positioning balloon comprises a major arc segment circumferentially disposed around more than 180 degrees of the body.

107. The method of any one of claims 102 to 106, wherein the positioning balloon comprises a non-uniform wall thickness configured to control expansion of the positioning balloon away from an axial center of the distal opening to expand toward and into the vaginal wall.

108. A cervical control system, comprising: a body defining an internal passage for receiving a cervix, the body including an upper portion and a lower portion defining proximal and distal openings, respectively, to the internal passage, and an outer surface for engaging a vaginal wall; an inner cuff coupled to the body at the proximal opening and configured to surround at least a portion of the cervix, the inner cuff being configured to expand from a neutral state to an inflated state in which the inner cuff is configured to engage at least a portion of the cervix, wherein the inner cuff comprises a non-uniform wall thickness configured to control expansion of the inner cuff, and wherein the inner cuff, when expanded, is configured to expand both radially inward and distally away from a transverse plane of the proximal opening and away from the uterus when the inner cuff surrounds the cervix; and an outer cuff coupled to the body at the distal opening and configured to surround at least a portion of the cervix, the outer cuff being configured to expand from a neutral state to an inflated state in which the outer cuff is configured to engage at least a portion of the cervix, wherein the outer cuff comprises a non-uniform wall thickness configured to control expansion of the outer cuff, and wherein the outer cuff, when expanded, is configured to expand both radially outward and distally away from a transverse plane of the distal opening and away from the uterus when the outer cuff surrounds the cervix. a positioning balloon disposed at one or both of an outer portion of the body and a lower portion of the body proximate the distal opening, the positioning balloon disposed about a portion of a circumference of the body and configured to inflate away from an axial center of the distal opening to inflate toward and into the vaginal wall, the positioning balloon inflatable from a neutral state to an inflated state, an outer perimeter of the positioning balloon in the inflated state greater than an outer perimeter of the positioning balloon when in the neutral state; wherein the positioning balloon comprises a minor arc segment shape disposed about less than 180 degrees of a circumference of the body, and wherein the positioning balloon comprises a non-uniform wall thickness configured to control inflation of the positioning balloon away from an axial center of the distal opening to inflate toward and into the vaginal wall.

109. A method of supporting and stabilizing a cervix, the method comprising: positioning a cervical control system about a cervix of a patient, the cervical control system comprising: a body defining an interior passage for receiving a cervix, the body comprising an upper portion and a lower portion defining proximal and distal openings, respectively, to the interior passage, and an outer surface for engaging a vaginal wall; an inner cuff coupled to the body at the proximal opening and configured to enclose at least a portion of the cervix; and a positioning balloon disposed at one or both of an outer portion of the body and a lower portion of the body proximate the distal opening, wherein the positioning balloon is disposed about a portion of a circumference of the body, wherein the positioning balloon comprises a minor arc segment disposed about less than 180 degrees of a circumference of the body; inflating the inner cuff to inflate the inner cuff from a neutral state to an inflated state in which the inner cuff engages at least a portion of the cervix; wherein the inner cuff comprises a non-uniform wall thickness configured to control inflation of the inner cuff, and wherein the inner cuff inflates both radially inward and distally away from a transverse plane of the proximal opening and away from the uterus when the inner cuff encloses the cervix; and inflating the positioning balloon to inflate the positioning balloon away from an axial center of the distal opening to inflate toward and into the vaginal wall, the positioning balloon inflatable from a neutral state to an inflated state, an outer perimeter of the positioning balloon in the inflated state greater than an outer perimeter of the positioning balloon when in the neutral state, wherein the positioning balloon comprises a non-uniform wall thickness configured to control inflation of the positioning balloon away from an axial center of the distal opening to inflate toward and into the vaginal wall.

110. Use of a cervical control system according to any of the preceding claims, wherein the cervical control system is used to delay delivery.

111. Use of a cervical control system according to any of the preceding claims, wherein the cervical control system is used to support a weak cervix or to treat cervical insufficiency.

112. Use of a cervical control system according to any of the preceding claims, wherein the cervical control system is used to treat prolapse.

113. Use of a cervical control system according to any of the preceding claims, wherein the cervical control system is used to treat one or more of incontinence, pelvic organ pain or compression, bleeding, and bladder disease.

114. A kit comprising a cervical control system according to any of the preceding claims and an inflation medium delivery device.

115. A method of operating a system or device according to any of the preceding claims.

116. A kit comprising: a cervical control system according to any of the preceding claims; a source of inflation medium; and a valve housing configured to be in fluid communication with the inflation medium conduit of the cervical control system.

117. The kit of claim 116, further comprising: a speculum.

118. The kit of claim 116 or 117, further comprising: a measuring device.

119. The kit of claim 118, wherein the measuring device is configured to measure the length of a cervix.

120. The kit of any of claims 116 to 119, wherein the source of inflation medium is at least one of a syringe, a pump, and an inflation medium container.

121. The kit of any of claims 116 to 120, further comprising: a cervical stabilizing device.

122. The kit of any of claims 116 to 121, further comprising: at least one of a pair of forceps and a tenaculum.

123. A kit comprising: a cervical control system comprising: a body configured for insertion into a patient’s vagina such that an internal passage of the body can accept insertion of a patient’s cervix, the body comprising: an internal passage configured for receiving a patient’s cervix therein; an inflation medium conduit disposed within a sidewall of the body, a first end of the inflation medium conduit open to and configured to be in fluid communication with an internal cavity defined by a flexible membrane of an internal cuff of the cervical control system, and a second end of the inflation medium conduit comprising an inlet configured to receive fluid for communication with the internal cavity of the internal cuff via the first end of the inflation medium conduit; an internal cuff comprising: a flexible membrane defining an internal cavity therein, the flexible membrane configured to expand upon addition of inflation medium to the internal cavity via the first end of the inflation medium conduit. a source of inflation medium; and a valve housing configured to be in fluid communication with the inflation medium conduit of the cervical control system.

124. The kit of claim 123, further comprising: a speculum.

125. The kit of claim 123 or 124, further comprising: a measuring device. ​ 126. The kit of any one of claims 123-125, wherein the measurement device is configured to measure a length of the cervix.

127. The kit of any one of claims 123-126, wherein the source of inflation medium is at least one of a syringe, a pump, and a saline container.

128. The kit of any one of claims 123-127, further comprising: a cervical stabilization device.

129. The kit of any one of claims 123-128, further comprising: at least one of a pair of forceps and a tenaculum.

130. A method of placing a cervical control system according to any one of the preceding claims, the method comprising: inserting the cervical control system into a patient’s vagina; positioning the patient’s cervix in the internal passageway of the cervical control system; and inflating the inner sleeve balloon to secure the cervix in the internal passageway.

131. The method of claim 130, wherein inflating the inner sleeve balloon causes the cervix to be compression closed.

132. The method of claim 130 or 131, wherein inflating the inner sleeve balloon causes the cervix to be lengthened closed.

133. The method of any one of claims 130-132, wherein inflating the inner sleeve balloon facilitates formation of a cervical mucus plug.

134. The method of any one of claims 130-133, wherein the cervical control system comprises a positioning balloon, the method further comprising: inflating the positioning balloon to adjust an angle of orientation of the cervix.

135. The method of any one of claims 130-134, wherein the cervical control system comprises a positioning balloon, the method further comprising: inflating the positioning balloon to anchor the cervical control system within the patient’s vagina.

136. The method of any one of claims 130-135, wherein the cervical control system comprises a positioning balloon, the method further comprising: inflating the positioning balloon to lengthen the cervix.

137. The method of any one of claims 130-136, wherein the cervical control system comprises a positioning balloon, the method further comprising: inflating the positioning balloon to compression close the cervix.

138. The method of any one of claims 130-137, wherein placement of the cervical control system is in response to the patient being associated with a risk factor for preterm birth.

139. The method of any one of claims 130-138, wherein placement of the cervical control system is in response to the patient being associated with an indication for preterm birth.

140. The method of any one of claims 130-139, wherein placement of the cervical control system is in response to the patient being diagnosed with a short cervix.

141. The method of any one of claims 130-140, wherein placement of the cervical control system is in response to the patient being associated with an indication for pelvic organ prolapse. ​ 142. The method of any of claims 130 to 141, wherein the placement of the cervical control system is in response to a patient being diagnosed with premature rupture of membranes (PROM) or preterm premature rupture of membranes (PPROM).

142. The method of any of claims 130 to 141, wherein the placement of the cervical control system is in response to a patient being diagnosed with premature rupture of membranes (PROM) or preterm premature rupture of membranes (PPROM).

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