Cervical control device, cervical control system, and method for using the same

Abstract

Systems, devices, and methods are provided for controlling, supporting, and / or elongating the cervix in order to treat pregnancy complications and / or delay the onset of labor, thereby prolonging the gestation period of the fetus and thereby preventing premature birth and delivery of the fetus. The cervical control system may include a main body configured for placement in the vagina. The main body has an internal passage configured for receiving the cervix therein, and an inflatable and / or expandable internal cuff extending from a portion of the internal passage. The internal cuff may be expandable inward toward the cervix, or inward toward the uterus, or both inward and inward, so that the internal cuff may engage with or grasp the cervix, thereby holding the cervical control system in place while compressing and closing the cervix, elongating the cervix, and / or adjusting the angle of orientation of the cervix.

Description

Technical Field

[0001] Related Applications This international PCT application was filed on March 1, 2023, claiming priority to U.S. Provisional Patent Application No. 63 / 487,802, entitled "DEVICE FOR REDUCTION OR PREVENTION OF PRETERM LABOR", and U.S. Provisional Patent Application No. 63 / 617,030, entitled "SYSTEMS AND DEVICES FOR CERVICAL SUPPORT AND FLUID DELIVERY AND METHODS FOR USING SAME", filed on January 2, 2024, the entireties of both of these U.S. provisional patent applications being incorporated herein by reference.

[0002] The present disclosure is directed to reproduction, pregnancy, and prenatal health, and, for example, devices, methods, and systems for controlling the cervix to prevent preterm labor, prevent pregnancy complications, and / or reduce and / or treat pelvic organ prolapse.

Background Art

[0003] The most common cause of infant mortality is complications resulting from preterm labor. Most commonly, several factors contribute to preterm labor, including cervical incompetence, which is medically referred to as "cervical shortening". In singleton pregnancies (i.e., single fetus pregnancies), when the cervix is short, a common intervention method includes sutures placed on the cervix to delay childbirth, known as cervical cerclage. Generally, interventions for cervical incompetence in multiple pregnancies (i.e., multiple fetus pregnancies) are limited and may have only limited effects.

[0004] Another intervention for a short cervix is ​​the application of vaginal progesterone to the cervix to help maintain its length and structure. However, vaginal progesterone cannot remain in place for extended periods because vaginal secretions wash the medication away over time. Furthermore, applying vaginal progesterone to the cervix is ​​an invasive procedure that requires transvaginal access by a clinician. [Overview of the project]

[0005] This specification discloses cervical control devices, systems, and methods of use thereof for controlling and / or regulating the anatomical and / or functional aspects of the cervix of a pregnant mammal (most often a pregnant human woman, sometimes referred to herein as “patient”), including, but not limited to, the length, degree of dilation, and orientation of the cervix. For example, the systems, devices, and / or methods disclosed herein may be used to compress the cervix, which may be partially dilated, closed, or not partially dilated, thereby delaying the onset of labor and / or allowing the regeneration of the cervical mucus plug. Additionally or alternatively, the systems, devices, and methods disclosed herein may be used when the patient is associated with risk factors and / or indicators of premature rupture of membranes (PROM) or premature rupture of membranes (PPROM). In these cases, compression of the cervix via the use of the systems, devices, and methods disclosed herein may act to keep the cervix closed so that leakage of amniotic fluid from the membrane can be delayed or stopped, and / or amniotic fluid lost due to a ruptured amniotic membrane can be replenished.

[0006] Additionally or alternatively, the systems, devices, and methods disclosed herein may be used when a patient is associated with risk factors and / or indicators of premature labor and / or cervical shortening. Additionally or alternatively, the systems, devices, and / or methods disclosed herein may also be used to support the patient's uterus and / or pelvic organs to avoid and / or mitigate the effects of pelvic organ prolapse. The functions of the cervical control devices and / or systems disclosed herein include, but are not limited to, preventing premature labor and / or premature delivery, thereby extending the gestation period of the patient's fetus.

[0007] The use of the systems, devices, and / or methods disclosed herein may depend on one or more factors and / or indicators, including but not limited to the patient's medical history, condition, age, and / or risk factors, which may be determined through the patient's blood tests and / or the analysis of images of the patient's uterus and / or cervix (e.g., ultrasound). In some cases, the systems, devices, and / or methods disclosed herein may be used to prevent labor and / or the onset of preterm birth in moderate and / or high-risk situations, even when there are no indicators or symptoms associated with conditions that may cause preterm birth, in order to prevent preterm birth.

[0008] The cervical control devices and / or systems disclosed herein may include a body configured for insertion into the patient's vagina, such that its internal passage can receive the insertion of the patient's cervix. The body may be flexible and / or foldable to facilitate compression, deformation, and / or folding before insertion into the vagina, and may be sized and / or shaped to occupy the space in the vagina near the anterior and / or posterior fornix. The internal passage may be configured to receive the patient's cervix therein and may be defined by a cylindrical opening or orifice located within the body. The internal passage may extend from one end of the body to the other. In some embodiments, a portion of the internal passage and / or the outer surface of the internal cuff may contain, and / or be coated with, for example, a drug, an antimicrobial agent, a friction enhancer, and / or an adhesive.

[0009] The main body may also include an inflation medium conduit disposed within its side wall. The first end of the inflation medium conduit may be configured to open into an internal chamber defined by the flexible membrane of the inner cuff of the cervical control device and / or system, and to be in fluid communication with the internal chamber. The second end of the inflation medium conduit may have an inlet configured to receive a fluid and / or inflation medium (e.g., water, saline, hydrogel, fluid, gas, etc.) for communication with the internal chamber of the inner cuff via the first end of the inflation medium conduit. For the purposes of discussion, the portion of the main body near the inner cuff may be referred to herein as the proximal or upper portion or proximal or upper of the cervical control device and / or system and / or main body, and the portion of the main body opposite the inner cuff may be referred herein as the distal or lower portion or distal or lower of the cervical control device and / or system and / or main body.

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

[0011] The inner cuff may include a flexible membrane that defines an internal chamber. The flexible membrane may be configured to expand when an expansion medium can be added to the internal chamber via a first end of an expansion medium conduit and / or when it can be pressurized in another way. In some embodiments, the flexible membrane expands radially inward toward the inner passage, so that the outer surface of the inner cuff contacts and compresses the cervix positioned within the inner passage, and as the volume of expansion medium added to the internal chamber increases, the compressive force applied to the cervix by the expanding flexible membrane also increases.

[0012] Additionally or alternatively, the flexible membrane may expand downward or distally, thereby drawing the cervix further into the internal passage and / or stretching the cervix within the internal passage. Additionally or alternatively, the expansion of the flexible membrane may act to adjust the angle of orientation of the cervix, the degree of cervical expansion, and the length of the cervix. In some cases, if the volume of the expanding medium added to the internal chamber increases, the stretching force applied to the cervix by the expanding flexible membrane may also increase. In some embodiments, the expansion of the flexible membrane may act to twist or otherwise bend the cervix.

[0013] In some embodiments, the thickness of the flexible membrane may be constant or uniform across and / or throughout the flexible membrane, while in other embodiments, the thickness of the flexible membrane may be variable across the flexible membrane. For example, if the inner cuff can be in a neutral or non-expanding state, the apex portion of the flexible membrane may be thicker than the upper or proximal portion and / or lower or distal portion of the flexible membrane. In this example, the thickness of the apex portion of the flexible membrane may decrease as the flexible membrane expands to facilitate the expansion of the inner cuff. Additionally or alternatively, if the inner cuff can be in a neutral state, the length of the upper or proximal portion of the flexible membrane may be longer than the length of the lower or distal portion of the flexible membrane, and in this example, since the length of the proximal portion of the flexible membrane is longer, the flexible membrane may expand distally and / or downward. Additionally, or alternatively, the flexible membrane may include buckles or other features configured to assist in the expansion of the flexible membrane if the internal chamber can be expanded.

[0014] In many cases, the flexible membrane of the inner cuff may be further configured to deflate or contract when the inflatable medium is withdrawn from the inner chamber. The degree of expansion or contraction of the flexible membrane of the inner cuff may be controlled by the volume of the inflatable medium present in the inner chamber and / or the degree of pressure within the inner chamber. The degree of expansion or contraction of the flexible membrane of the inner cuff may depend, for example, on patient comfort, clinical need, cervical orientation, orientation of the patient's uterus, degree of cervical dilation, cervical length, degree of cervical softness, and / or indicators of the patient's amniotic sac status.

[0015] In some embodiments, the inner cuff may further include a plurality (e.g., two, three, four, or six) flexible membranes, each of which may define a separate internal chamber therein, the internal chambers of which are in fluid communication with an expansion medium conduit and may be configured to expand when the expansion medium is added to each internal chamber and to contract when the expansion medium is withdrawn from each internal chamber.

[0016] In some embodiments, the flexible membrane may further include one or more expandable portions configured to expand when an expansion medium is added to an internal chamber, and one or more recesses configured to expand minimally or not expand at all when the expandable portions are expanded. Sometimes, the second recess may be positioned about 180 degrees opposite to the first recess. One or more recesses may be sized, configured, and / or positioned within the flexible membrane to coincide with the predicted location of cervical blood vessels (e.g., arteries), so that when the flexible membrane is expanded, the recesses do not expand as much as the expandable portions, thereby avoiding compression of the cervical blood vessels, and consequently allowing blood to flow throughout the cervix, which is particularly important for the long-term use (e.g., hours or days) of the devices and / or systems disclosed herein.

[0017] Sometimes, one or more cleats may be present, positioned on and extending from the outer surface of the flexible membrane and / or the expandable portion of the flexible membrane. In some cases, the cleats may not be positioned on the outer surface of the recess. The cleats may be configured to press in and hold the cervix, and / or to increase the coefficient of friction between the cervix and the flexible membrane, for example, to effectively hold the cervix within the internal passage, and / or to prevent unintended movement of the cervical control device and / or system (e.g., slipping out of the cervix).

[0018] One or more cleats may have semicircular, rectangular, parallelogram, triangular, oval, trapezoidal, hook-shaped, curved, and irregularly radial cross-sectional and / or elevation profiles. The cleats may be arranged in any manner, including, but not limited to, one or more concentric rows, multiple columns, and various points in an array of offset cleats extending from the outer surface of the flexible membrane.

[0019] In some embodiments, the cervical control devices and / or systems disclosed herein include a valve and / or a valve housing, and / or the valve and / or valve housing may be permanently or detachably coupled. The valve may be configured for fluid communication with a second end of the inflation medium conduit and for indirect fluid communication with the internal chamber. For example, the valve and / or valve housing may be configured to receive the insertion of an inflation medium source into it. The inflation medium can then be transferred from the inflation medium source through the valve to the inflation medium conduit. When the inflation medium source is removed from the valve, the valve closes, thereby confining the inflation medium within the inflation medium conduit and internal chamber, and holding the flexible membrane in an inflated state. If deflation of the inner cuff / flexible membrane is desired, the valve can be opened, as a result allowing some or all of the inflation to escape from the inflation medium conduit and / or internal chamber. Exemplary sources of the inflation medium include, but are not limited to, syringes, pumps, and tubing.

[0020] Exemplary valves include, but are not limited to, one-way valves, duckbill valves, silicone valves, check valves, Halkey-Roberts valves, Luer-operated check valves, check valves with polycarbonate bodies, and check valves. In some embodiments, the valve and / or valve housing may be permanently or detachably coupled to a second end of the 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 catheter which can be permanently or detachably coupled to the valve and / or valve housing.

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

[0022] In some embodiments, the inflation medium conduit may be configured to extend outside the main body (e.g., having sufficient length) so that it can be accessed from outside the patient's vaginal opening. Alternatively, the second end of the inflation medium conduit may be coupled to a tube or catheter (e.g., having sufficient length) configured to extend outside the main body, thereby allowing access from outside the patient's vaginal opening without obstructing or moving the cervical control device and / or system when it is in place. Sometimes, the valve and / or valve housing may be configured to be detached after use from the second end of the expansion medium conduit and / or the tube connected thereto, so that the second end of the expansion medium conduit and / or the tube connected thereto can be positioned in the patient's vaginal canal and / or taped to the patient's leg, thereby reducing the weight of the system comprising the cervical control device and / or system and the valve / valve housing, thereby reducing the possibility that gravity could pull the system away from its preferred position and / or improve patient comfort when the cervical control device and / or system is in place but the valve and / or valve housing is not in use.

[0023] In many embodiments, the cervical control devices and / or systems disclosed herein may include a positioning balloon disposed on the outer surface of a body, which may be expandable when an inflation medium is placed therein. In some embodiments, the positioning balloon may include a flexible membrane defining an internal chamber configured for receiving the inflation medium. As the internal chamber is filled with the inflation medium, the flexible membrane of the positioning balloon expands outward from the outer surface of the body, thereby expanding the outer periphery of a portion of the cervical control device and / or system. Sometimes, the cervical control devices and / or systems disclosed herein may include a second or positioning balloon inflation medium conduit disposed within the side wall of the body. The first end of the positioning balloon inflation medium conduit may open to the positioning balloon internal chamber defined by the flexible membrane of the positioning balloon and be configured to fluidly communicate with the positioning balloon internal chamber. The second end of the positioning balloon inflation medium conduit may include an inlet or valve configured to receive insertion of the inflation medium to communicate with the positioning balloon internal chamber via the first end of the positioning balloon inflation medium conduit. Sometimes, the positioning balloon inflation medium conduit may be in communication with the inner cuff inflation medium conduit, so that the inflation medium entering the inlet can communicate with the inner cuff and / or the positioning balloon.

[0024] Similar to the expansion medium conduit for the inner cuff, the second end of the positioning balloon expansion medium conduit may be permanently or removablely coupled to a valve and / or valve housing. This valve and / or valve housing may be similar to the valve and / or valve housing permanently or removablely coupled to the second end of the inner cuff expansion medium conduit.

[0025] The positioning balloon may surround all or part (e.g., 20–75%) of the distal portion of the outer surface of the main body. Additionally or alternatively, the positioning balloon may be located at the distal end of the main body. In some embodiments, the positioning balloon may be configured to adjust the orientation of the cervical control device and / or system when placed in the vagina and inflated. Additionally or alternatively, the positioning balloon may be configured to adjust the angle of cervical orientation when inflated.

[0026] In some embodiments, the cervical control devices and / or systems disclosed herein can be manufactured and / or molded integrally. In these embodiments, the flexible membrane may be molded to include a first extension surrounding the proximal edge of the flexible membrane and a second extension surrounding the distal edge of the flexible membrane, and the body may be molded to include a first groove sized, positioned and configured to receive the first extension and a second groove sized, positioned and configured to receive the second extension, and the inner cuff may be formed such that the first extension can be positioned in the first groove and the second extension can be positioned in the second groove.

[0027] Additionally, or alternatively, in some embodiments, the cervical control devices and / or systems disclosed herein may further comprise a liquid delivery device, conduit, or channel having at least one port configured to enable delivery and / or leaching of liquid from the liquid delivery device to the cervix. The liquid delivery device may be disposed near an inner surface of an internal passageway and / or inner cuff and / or its flexible membrane, and may be in liquid communication with a liquid conduit. The liquid leaching from and / or delivered by the liquid delivery device includes, but is not limited to, drugs, antibacterial agents, hormones. Sometimes, the liquid conduit may communicate with an inflation medium conduit and / or an internal chamber of the inner cuff. In these embodiments, the inflation medium may be a fluid intended to be delivered to the cervix via the liquid delivery device, such that the internal chamber of the inner cuff and / or positioning balloon is inflated using this fluid.

[0028] Also disclosed herein are kits comprising one or more cervical control devices and / or systems disclosed herein, together with, for example, an inflation medium source, a speculum, a measurement device configured to measure, for example, the length and / or degree of structural integrity of the cervix, forceps, a cervical stabilization device, a tenaculum, and / or a sensor. In some embodiments, the kit may also include a valve housing configured to be in fluid communication with an inflation medium conduit (e.g., an inner cuff and / or positioning balloon inflation medium conduit) of the cervical control device and / or system included in the kit. Exemplary inflation medium sources include, but are not limited to, syringes, pumps, containers of inflation medium.

[0029] In some embodiments, the cervical control devices and / or systems disclosed herein can provide selectively adjustable or customizable support and / or control to a patient's cervix, and can, for example, be useful in delaying labor in both singleton and multiple pregnancies in individuals experiencing an incompetent cervix. In some embodiments, the cervical control devices and / or systems disclosed herein can be utilized to support or mitigate 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 bladders (sometimes collectively referred to herein as "cuffs"), which can be selectively inflatable and deflatable individually and / or collectively to provide a desired amount of cervical control, cervical compression, and / or cervical position correction. The cervical control devices and / or systems disclosed herein include a proximal or inner cuff configured and arranged to engage, control, and / or support the cervix, uterus, and / or fetus, and an outer and / or positioning balloon configured and / or arranged to engage the patient's vaginal wall upon inflation to support the cervical control devices and / or systems disclosed herein near the cervix. The inner cuff can be utilized to provide a compressive force that cinches against the outside of the cervix at the top of the dome to close and / or hold the cervix in a closed state.

[0030] The inner and / or positioning balloons can include one or more individually addressable (e.g., inflatable / deflatable) bladders having a flexible membrane and an internal chamber. The inner cuff bladders can be configured to cooperate with each other to inflate and compress the cervix. Sometimes, the inner cuff can be configured to allow perfusion of blood / fluid in the cervix (such as by inflating an expandable portion of the inner cuff) while providing a sufficient amount of compressive force against the cervix.

[0031] The anatomical structure of the cervix may vary in nominal external dimensions from patient to patient, and an inadequate cervix may (likely) continue to shrink as pregnancy progresses. Therefore, the adjustable functionality of the cervical control devices and / or systems disclosed herein may allow healthcare providers (e.g., physicians, midwives, or nurses) to customize cervical support and / or control for a particular patient's cervix by directing and / or adjusting the inflation / deflation of the internal cuff.

[0032] Sometimes, a positioning balloon can be used to adjust the position of one or more cervical control devices and / or systems disclosed herein when placed in the patient's vagina, and these adjustments can be made to adjust the orientation of each cervical control device and / or system relative to the cervix, thereby changing the orientation of the cervix and / or twisting the cervix.

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

[0034] The use of the cervical control devices and / or systems disclosed herein may also be beneficial in reducing or limiting the risk of infection and / or prolonging fetal growth in cases of premature rupture of membranes (PROM) or premature rupture of membranes (PPROM). This is because the cervical control devices and / or systems act to keep the cervix closed, thereby preventing bacteria and foreign bodies (which can cause infection) from migrating into the cervix and / or uterus. Furthermore, the cervical compression provided by the cervical control devices and / or systems disclosed herein provides an opportunity for the regrowth of the cervical mucus plug, which also helps prevent bacteria from migrating into the cervix and uterus. This is particularly advantageous because, conventionally, there has been no treatment for patients who have experienced PROM or PPROM. Cervical cerclage is contraindicated due to the risk of causing infection or cervical laceration that may occur during delivery.

[0035] Furthermore, the cervical control devices and / or systems disclosed herein may be configured to contact / engage with the outside of the cervix while not contacting (or minimally contacting) the cervix. Thus, the cervical control devices and / or systems disclosed herein can provide supportive control of the cervix without causing infection to the uterus. Mechanical closure and angle adjustment of the cervix can increase amniotic fluid retention and improve fetal outcomes. In addition, because the cervical control devices and / or systems disclosed herein may not cover the opening of the cervix (like a cervical cap) during use, they do not create an environment in which anaerobic bacteria can thrive, and therefore, the use of the cervical control devices and / or systems disclosed herein may be safer than the use of a cervical cap, which covers the opening and creates an environment in which bacteria can thrive.

[0036] According to some embodiments, the cervical control devices and / or systems disclosed herein may comprise a body defining an internal passage for receiving the cervix, the body comprising an upper and lower portion defining a proximal and distal opening to the internal passage, respectively, and an outer surface for engaging with the vaginal wall. An internal cuff may be coupled to and / or extend from the body at or near the proximal opening. When in an unexpanded state, the internal cuff may be configured to receive the insertion of the cervix and surround at least a portion of the cervix. When positioned in place, the internal cuff may be configured to expand from a neutral to an expanded state, thereby contacting and / or engaging with at least a portion of the cervix. Once the cervix is ​​secured by the internal cuff, a positioning balloon may be inflated, thereby expanding into the vaginal wall away from the axis of the distal opening and toward the vaginal wall.

[0037] The cervical control devices and / or systems disclosed herein may include one or more of the following features: In one embodiment, the positioning balloon may have a subarc shape positioned around less than 180 degrees of the circumference of the outer or lower (distal) surface of the body. In another embodiment, the positioning balloon may have a superarc shape positioned beyond 180 degrees of the circumference of the outer or lower (distal) surface of the body. In some embodiments, in the expanded state, the radius of the cervical control devices and / or systems disclosed herein, measured from the axis of the distal opening to the outer circumference of the positioning balloon, may be greater than the radius of the device from the axis of the distal opening to the outer circumference of the body in a portion of the circumference of the body without the positioning balloon. In some embodiments, the positioning balloon may have varying or non-uniform wall thicknesses (and / or elasticity or flexibility) configured to control the expansion of the positioning balloon into the vaginal wall, away from the axis of the distal opening. In some embodiments, the positioning balloon may have a first wall thickness on the proximal side of the device, a second wall thickness on the distal side of the device, and a third wall thickness on the outer circumference of the positioning balloon extending 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 first and second walls may be of different lengths. In some embodiments, the body may have a hemispherical or other curved shape, and the proximal opening may define a smaller area than the distal opening. In one embodiment, the cervical control device disclosed herein may further comprise one or more cleats disposed along the inner circumference of the inner cuff to grasp the outside of the cervix and to hold the cervical control device in place relative to the cervix.

[0038] In some embodiments, the internal cuff is configured to expand substantially radially inward toward the axis of the proximal opening and / or downward away from the cross-section of the proximal opening and away from the uterus as it expands around the cervix during expansion.

[0039] Additionally or alternatively, the inner cuff and / or its flexible membrane may have non-uniform wall thicknesses. For example, the flexible membrane of the inner cuff may have a first wall thickness on the proximal side of the device, a second wall thickness on the distal side of the device, and a third wall thickness on the inner surface of the inner cuff extending 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] Additionally, or alternatively, the internal cuff may include an internal wall configured to be at an angle to the axis of the proximal opening. Additionally, or alternatively, the internal cuff may include an internal wall opposite to the wall on the inner surface of the internal cuff, and the internal wall may be configured to be parallel to the axis of the proximal opening.

[0041] Additionally or alternatively, the inner cuff may include an expandable portion adjacent to the recess, the expandable portion being selectively extendable further into the internal passage than the recess. In some embodiments, the inner cuff may have non-uniform wall thicknesses, and the recess may have a thicker wall thickness than the expandable portion, the thicker wall thickness of the recess limiting the expansion of the recess relative to the expandable portion during expansion. In some embodiments, the inner cuff may comprise at least two of the recesses and at least two of the expandable portions arranged alternately with the recesses.

[0042] Additionally or alternatively, the cervical control devices disclosed herein may further comprise one or more inflation medium conduits, sized, shaped, and configured to facilitate fluid communication with an inner balloon and / or positioning balloon, and communication with an inflation medium to and from the inner cuff and / or positioning balloon. Sometimes, the inflation medium conduits may be configured to accept the insertion and / or withdrawal of the inflation medium via an inlet, port, and / or valve. In some embodiments, the valves may be operable to detachably accept a portion of the device that is operable to inflate the first balloon and / or positioning balloon without removing the inflation 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 main body. The pump may be in fluid communication with the fluid reservoir, which may be in fluid communication with the inner cuff and / or positioning balloon, and may be configured to move or transfer an inflation medium between the fluid reservoir and the inner cuff and / or positioning balloon for inflation and / or deflation of the inner cuff and / 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 comprise a hemispherical or other curved body defining an internal passage for receiving the cervix, the body comprising an upper and lower portion defining a proximal and distal opening, respectively, and an outer surface for engaging with the vaginal wall to support the device near the cervix, the body (e.g., a hemispherical body) comprising an internal 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 on one or both of the outer portion of the body and the lower portion of the body near the distal opening, the positioning balloon configured to expand away from the axis of the distal opening and expand toward the vaginal wall into the vaginal wall, the positioning balloon expands from a neutral position The device may include a positioning balloon that is expandable to a state in which the outer circumference of the positioning balloon is enlarged compared to its outer circumference when it is in a neutral state; an inflation medium conduit having a first end configured to fluidize with a first and / or positioning balloon and a second end opposite to the first end; a valve having a first end configured to fluidize with the second end of the inflation medium conduit and a second end opposite to the first end configured to receive a portion of an inflation device that can operate to inflate the first and / or positioning balloon without removing the device from the patient's vagina; and a valve housing having a first end configured to receive the inflation medium conduit and a second end having 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 devices disclosed herein may be permanently or detachably coupled to a valve and / or valve housing that may include sensors and / or pressure gauges configured to provide tactile and / or visual indicators of pressure within an internal cuff and / or positioning balloon. In some embodiments, the pressure gauge may include a pressure balloon configured to be inflated in stages to indicate how much the pressure has increased within the device. In some embodiments, the pressure balloon may have a variable wall thickness and / or be color-coded, the color coding may be configured to indicate different pressure levels within a first and / or positioning balloon.

[0046] The devices described herein are described as “cervical control devices,” but such devices may, in some embodiments, also be used to support other tissues, such as the uterus or bladder, in place of or in addition to the cervix, as can occur in pelvic organ prolapse. In the case of pelvic organ prolapse (POP), the cervical control devices disclosed herein may be used to support the prolapsed tissue or organ, and / or the displaced tissue or organ, or the tissue or organ causing discomfort to the patient. For example, when the cervical control devices disclosed herein are used to treat bladder prolapse, the cervical control devices may be placed in the vaginal canal to keep the bladder elevated in the pelvis. In the case of uterine prolapse, the cervical control devices disclosed herein may be used to keep the uterus elevated in the pelvis and prevent the uterus from descending into the vaginal canal or protruding out of the vaginal opening.

[0047] In some embodiments described herein, the cervical control device disclosed herein may be configured to expand from a neutral state to an expanded state. This includes, for example, expansion from an expanded state or a lower expanded state to a higher expanded state. In some embodiments, expansion may occur gradually over time or all at once, and the degree of expansion of the internal and / or positioning balloon may depend, for example, on the patient's physiological state and / or patient comfort.

[0048] In some embodiments, the devices described herein are coated with, embedded with, and / or otherwise contain, one or more active or inactive agents, such as drugs, hormones, antistimulants, lubricants, progesterone, uterine contraction inhibitors, antimicrobial APIs (active pharmaceutical ingredients), or silver nitrate (inactive pharmaceuticals may also be used).

[0049] In some embodiments, the devices and methods described herein work synergistically with drugs that delay premature labor (such as oral or intravenous drugs) (such as drugs that can slow or stop uterine contractions). In some embodiments, when one of the cervical control devices disclosed herein is used to control the cervix according to one or more embodiments described herein, such drugs may be required for shorter periods, at lower doses, or not at all, thus reducing undesirable side effects.

[0050] In another embodiment, a method is provided for supporting and reinforcing tissue (such as the cervix), which may include positioning a cervical control device around the patient's tissue (e.g., the cervix). The cervical control device may comprise a body defining an internal passage for receiving the tissue (e.g., the cervix), an upper and lower portion defining a proximal and distal opening to the internal passage, respectively, and an outer surface (e.g., for engaging with the vaginal wall or other structure). An internal cuff may be attached to and / or extend from the body at or near the proximal opening. The internal cuff may be configured to surround at least a portion of the tissue (e.g., the cervix). The cervical control device may further include a positioning balloon disposed on the outer portion of the body and / or on the lower portion of the body near the distal opening, the positioning balloon being disposed around a portion of the circumference of the body. When positioned correctly, the internal cuff is inflated, expanding from a neutral to an expanded state, so that the internal cuff may contact and / or engage with at least a portion of the tissue (e.g., the cervix). The positioning balloon can also be inflated, and when inflated, the positioning balloon can expand away from the axis of the distal opening toward a desired region (e.g. toward the vaginal wall toward the vaginal wall toward the vaginal wall), and the positioning balloon is expandable from a neutral to an expanded state, in which the outer circumference of the positioning balloon is enlarged compared to its outer circumference in the neutral state.

[0051] In some embodiments, the cervical control device may further comprise an inflation medium conduit that is in fluid communication with a first and / or positioning balloon, and a valve that is in fluid communication with the inflation medium conduit. In some embodiments, the method may further include connecting the inflation device to the valve to inflate the inner cuff and / or positioning balloon in place 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 have a subarc shape that is positioned around less than 180 degrees of the circumference of the body. In some embodiments, the positioning balloon may have a superarc shape that is positioned beyond 180 degrees of the circumference of the body. In some embodiments, the positioning balloon may have a non-uniform wall thickness configured to control the expansion of the positioning balloon so that, when in place, it expands into the vaginal wall toward the vaginal wall away from the axis of the distal opening.

[0052] According to another embodiment, a method for treating prolapse may include positioning a cervical control device, such as the cervical control device disclosed herein, around the patient's cervix, the cervical control device may comprise a body defining an internal passage for receiving the cervix, an upper and lower portion defining a proximal and distal opening to the internal passage, respectively, and an outer surface for contacting, engaging, and / or wedge-in with the vaginal wall. The cervical control device may further comprise a positioning balloon disposed on the outer edge and / or lower (or distal) edge of the body near the distal opening. If the positioning balloon is disposed around a portion of the outer circumference of the body, inflation of the positioning balloon may act to expand the positioning balloon in a desired direction (e.g., into the vaginal wall, away from the axis of the distal opening).

[0053] According to another embodiment, the cervical control device may comprise a body defining an internal passage for receiving the cervix, the body comprising an upper and lower portion defining a proximal and distal opening to the internal passage, respectively, an outer surface for engaging with the vaginal wall, and an inner cuff coupled to and / or extending from the body at or near the proximal opening. The inner cuff may be configured to surround at least a portion of the cervix and to expand from a neutral state to an expanded state configured to engage with at least a portion of the cervix. Sometimes, the inner cuff may have a non-uniform wall thickness configured to control the expansion of the inner cuff in desired directions, such as radially inward and / or away from the cross-section of the proximal opening and downward away from the uterus, as the inner cuff expands around the cervix and engages with the cervix. The cervical control device may further comprise a positioning balloon disposed on the outer portion of the body and / or on the lower (distal) edge of the body near the distal opening. A positioning balloon may be positioned around a portion of the circumference of the main body and configured to inflate and expand into the vaginal wall, away from the axis of the distal opening. When the positioning balloon expands from a neutral state to an expanded state, the outer circumference of the positioning balloon is enlarged compared to its outer circumference in the neutral state. The positioning balloon may have a subarc shape positioned around less than 180 degrees of the circumference of the main body, and / or have a non-uniform wall thickness configured to control the expansion of the positioning balloon, for example, to expand into the vaginal wall, away from the axis of the distal opening, without expanding toward the distal or proximal opening.

[0054] According to several embodiments, a cervical control device is provided for supporting and / or controlling a patient's cervix and includes a main body sized and shaped for placement in the patient's vagina. The main body defines an internal passage having a proximal opening in the upper portion of the body and a distal opening in the lower portion of the body. In one embodiment, a portion of the outer circumference of the body is provided to engage with and press against the vaginal wall, or to be partially embedded, to secure the device near the cervical opening. In one embodiment, an expandable inner cuff is provided around the inside of the body near the proximal opening, so that the inner cuff defines at least a portion of the proximal opening. The inner cuff may be expandable toward the axis of the proximal opening so as to surround the lateral portion of the lower cervix. The inner cuff may be expandable from a neutral state to an expanded state, thereby reducing the area of ​​the proximal opening. In other words, when expanded, the inner cuff can expand inward to constrict the outside of the cervix. The inner cuff may include one or more recesses or minimally inflatable portions and one or more expanding portions or expandable portions adjacent to the recesses. The expandable portions may be expandable, for example, toward the axis of the proximal opening to contract the cervix, and the recesses of the inner cuff may generally remain uninflated or unexpanded to allow blood flow between the upper and lower (below the inner cuff) cervical tissue. Optionally, the cervical control device may include one, two, or more protrusions (such as annular protrusions) along the inner circumference of the inner cuff for grasping or engaging with the outside of the cervix, such as providing improved grip around the cervix as the inner cuff is inflated.

[0055] In some embodiments, the main body of the cervical control device disclosed herein may be a hemispherical body formed in a hemispherical shape, with a proximal opening defined in the upper portion of the hemispherical body and a distal opening defined in the lower portion of the hemispherical body. The proximal opening may have a smaller diameter and / or area than the distal opening. The outer portion of the body at or near the distal opening may be sized and shaped to engage with the vaginal wall to support the cervical control device in the vagina near the fornix and / or cervical opening. In other embodiments, the main body of the device is curved or arc-shaped at an angle ranging from 7 mm to 15 mm in radius, where the inner cuff transitions into the main body. The outer wall of the main body may be vertical or curved in an arc ranging from 20 mm to 50 mm in radius. The height of the main body may be, for example, 15 to 30 mm. In other embodiments, the main 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 positioning around the cervix and engaging with the vaginal wall.

[0056] Additionally or alternatively, the inner cuff of the cervical control device disclosed herein is expandable radially inward toward the axis of the proximal opening as the inner cuff expands around the cervix, and is also expandable downward away from the cross-section of the proximal opening and away from the uterus. For example, radially inward expansion of the inner cuff acts to constrict, for example, the lateral portion of the cervix, while downward expansion acts to pull or push the cervix downward away from the uterus.

[0057] Additionally or alternatively, the internal cuff may include two or more adjacent bladders, which are arranged, shaped, and dimensional such that when one or more of the inflatable bladders are inflated, the internal cuff expands radially inward and / or downward away from the cross-section of the proximal opening. For example, the internal cuff may include a first inflatable bladder coaxial with the proximal opening and a second inflatable bladder coaxial with the first inflatable bladder and the proximal opening. In one embodiment, the internal cuff is expandable from a neutral state to an expanded state, in which a portion of the internal cuff expands radially inward toward the axis of the proximal opening and downward away from the cross-section of the proximal opening and away from the uterus, thereby being able to exert a downward force on the outside of the cervix.

[0058] Additionally, or alternatively, the radial cross-section of one or more inner cuffs of the cervical control devices disclosed herein may be formed to have non-uniform wall thickness, thereby, during expansion, the arrangement of cuffs with non-uniform walls causes the inner cuff to expand radially inward and downward away from the cross-section of the proximal opening.

[0059] Additionally or alternatively, the cervical control devices disclosed herein may include an annular rim positioned near the upper (proximal) portion of the main body. The annular rim may extend upward away from the cross-section of the proximal opening. When the device is placed in the patient's vagina, the annular rim may be configured to first receive the lower end of the cervix and then guide the cervix into the proximal opening and medial passage, which may help the healthcare provider to properly position the device near and around the cervix.

[0060] The valves disclosed herein can detachably receive a portion of an inflation device (e.g., a pump and / or needle) that is capable of inflating an internal and / or positioning balloon without removing the cervical control device from the patient's vagina and / or removing the cervical control device from the cervix. The valves may be configured to minimize backflow of fluid after it has been directed towards the internal and / or positioning balloon.

[0061] In another embodiment, the cervical control device disclosed herein may include a second expandable annular cuff (also referred to herein as a “positioning balloon”) positioned near the lower portion and / or outward (convex) curvature of the main body, such as near the distal opening. The positioning balloon may be expandable outward away from the axis of the distal opening to expand toward and contact with the vaginal wall. The positioning balloon may be expandable from a neutral state to an expanded state, in which the outer circumference of the positioning balloon increases (compared to its outer circumference in the neutral state), expands to contact the vaginal wall, and can secure the device to the vaginal wall. The positioning balloon may be in fluid communication with an expansion medium conduit, such as an expansion medium conduit as described herein, for receiving fluid from or releasing fluid into the positioning balloon. A single inflation medium conduit may be provided communicating with the distal and medial cuffs of the device, or separate, dedicated inflation medium conduits may be provided for the positioning balloon and the medial cuff, and / or dedicated inflation medium conduits may be provided for each individually addressable bladder of the medial and / or positioning balloon.

[0062] In some embodiments, a cervical control device and / or system may be provided to support a patient's cervix and may include a main body sized and shaped to be positioned within the patient's vagina. The main body has an upper portion defining a proximal opening and a lower portion defining a distal opening. The external portion of the body is configured to engage with the vaginal wall to support or secure the cervical control device and / or system near the cervical opening.

[0063] The cervical control devices and / or systems disclosed herein may include, for example, one or more expandable annular cuffs inside a body near the proximal opening, the inner cuff defining at least a portion of the proximal opening. In one embodiment, at least a portion of the inner cuff is expandable from a neutral state to an expanded state, in which case the inner cuff (i) expands radially inward toward the axis of the proximal opening to constrict the outer portion of the cervix, and (ii) expands downward away from the cross-section of the proximal opening and away from the uterus to apply a downward force to the outside of the cervix.

[0064] In some embodiments, the internal cuff may include one or more recesses and one or more expandable portions, spaced apart from each other around the circumference of the internal cuff. The expandable portions are expandable toward the axis of the proximal opening and also expandable downward away from the cross-section of the proximal opening. The recesses of the internal cuff may allow blood flow from the upper cervical tissue to the lower cervical tissue extending through the internal cuff.

[0065] In another embodiment, the radial cross-section of the inner cuff has a non-uniform wall thickness, and thereafter, based on the material properties of the non-uniform wall thickness, the inner cuff can expand both radially inward and downward away from the cross-section of the proximal opening when expanded.

[0066] In another embodiment, the inner cuff may include a plurality of adjacent and coaxial inflatable bladders. The plurality of inflatable bladders may be arranged such that when one or more of the bladders are inflated, the inner cuff expands radially inward toward the axis of the proximal opening and / or downward away from the cross-section of the proximal opening.

[0067] The cervical control systems, cervical control devices and / or methods disclosed herein may be used, for example, to delay labor, control the cervix, support a weak cervix, treat cervical incompetence, treat pelvic organ prolapse, treat incontinence, and treat pain or pressure in the pelvic organs, bleeding, and / or bladder symptoms.

[0068] A kit comprising one or more of the cervical control devices and / or systems disclosed herein and an inflation device is disclosed herein.

[0069] Accordingly, the cervical control devices and / or systems disclosed herein provide customizable and adjustable devices for supporting and / or controlling the cervix of patients with high-risk pregnancies and / or patients experiencing pregnancy complications that may progress to premature labor, such as insufficient cervix, PROM, PPROM, and / or cervical mucus plug insufficiency. The cervical control devices and / or devices disclosed herein include an internal cuff and / or individually addressable inflatable bladder, which allows a healthcare provider to direct compressive force to a desired position around the patient's cervix at the top of the fornix. The adjustable nature of the cervical control devices and / or devices disclosed herein allows a healthcare provider or user to adjust, for example, the amount of pressure applied to the cervix, compress and close the cervix, 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 removing the cervical control device and / or system through the vagina or directly manipulating it. The internal and / or positioning balloons disclosed herein may include various dimensional features or structural embodiments for expanding the internal and / or positioning balloon radially inward toward the cervix and / or downward away from the uterus to apply an oblique inward downward force to the cervix.

[0070] These and other purposes, advantages, objectives, and features of this disclosure will become apparent upon consideration of the following specification together with the drawings.

[0071] The following drawings are for illustrative purposes only and illustrate non-limiting embodiments. Features from different drawings may be combined in some embodiments. [Brief explanation of the drawing]

[0072] [Figure 1]This is a sagittal view of a patient with a multiple pregnancy, showing the arrangement of an exemplary cervical control system according to some embodiments of the present invention. [Figure 2] Another sagittal view of the patient in Figure 1, showing a cross-sectional side view of a cervical control system in which the internal cuff is in an inflated or expanded state, according to some embodiments of the present invention. [Figure 3] Figure 1 is a top perspective view of a cervical control system according to several embodiments of the present invention, with the inner cuff shown in a contracted or neutral state. [Figure 4] Figure 1 is a top perspective view of a cervical control system according to several embodiments of the present invention, with the inner cuff shown in an inflated state. [Figure 5] This is a cross-sectional side view of the cervical control system of Figure 1, along line V-V in Figure 3, showing the inner cuff in a contracted state, according to some embodiments of the present invention. [Figure 6] Another cross-sectional side view of the cervical control system of Figure 1, along line VI-VI in Figure 4, showing the inner cuff in an inflated state, according to some embodiments of the present invention. [Figure 7] This is a cross-sectional side view of another exemplary cervical control system according to some embodiments of the present invention, in which the inner cuff is shown in a contracted or neutral state. [Figure 8] Figure 7 is a cross-sectional side view of a cervical control system according to several embodiments of the present invention, in which the inner cuff is shown in an inflated or expanded state. [Figure 9] This is a radial cross-sectional side view of a portion of another internal cuff for a cervical control system according to some embodiments of the present invention. [Figure 10A] This is a radial cross-sectional side view of a portion of another internal cuff for a neutral cervical control system according to some embodiments of the present invention. [Figure 10B] This is a radial cross-sectional side view of a portion of the inner cuff of Figure 10A in an expanded state, according to some embodiments of the present invention. [Figure 11]This is a radial cross-sectional side view of a portion of another internal cuff for a cervical control system according to some embodiments of the present invention. [Figure 12] This is a radial cross-sectional side view of a portion of another internal cuff for a cervical control system, illustrated in a contracted or neutral state, according to some embodiments of the present invention. [Figure 13] This is a radial cross-sectional side view of a portion of the inflatable cuff of Figure 12, shown in an inflated or expanded state according to some embodiments of the present invention. [Figure 14] This is a cross-sectional side view of another cervical control system according to some embodiments of the present invention, in which the inner cuff is shown in a contracted or neutral state. [Figure 15] This is another cross-sectional side view of the cervical control system of Figure 14, in which the inner cuff is shown in an inflated or expanded state, according to some embodiments of the present invention. [Figure 16] Figure 14 is a cross-sectional side view of a cervical control system according to some embodiments of the present invention, showing the inner cuff in a contracted state, positioned appropriately around the patient's cervix at the top of the fornix. [Figure 17] Figure 16 is a cross-sectional side view of a cervical control system illustrating the patient's cervix at the upper part of a fornix extending into an opening formed by an internal cuff, according to some embodiments of the present invention. [Figure 18] Figure 17 is a cross-sectional side view of a cervical control system according to some embodiments of the present invention, in which the inner cuff is in an inflated state and engaged with or in contact with the outside of the patient's cervix at the top of the fornix. [Figure 19] This is a cross-sectional side view of another exemplary cervical control system, illustrated with a positioning balloon in a contracted or neutral state, according to some embodiments of the present invention. [Figure 20] Figure 19 is a cross-sectional side view of a cervical control system, illustrated with a positioning balloon in an inflated or expanded state, according to some embodiments of the present invention. [Figure 21] This is a partial radial cross-sectional side view of an exemplary cervical control system, including a pair of positioning balloons, illustrated in a contracted or neutral state, according to some embodiments of the present invention. [Figure 22] This is a radial cross-sectional side view of the positioning balloon of Figure 21, shown in an inflated or expanded state according to some embodiments of the present invention. [Figure 23] This is a top perspective view of another cervical control system according to some embodiments of the present invention, in which the internal cuff and positioning balloon are each shown in a contracted or neutral state. [Figure 24] Figure 23 is a bottom view of a cervical control system according to several embodiments of the present invention. [Figure 25] This is a top perspective view of another cervical control system according to some embodiments of the present invention, in which the internal cuff and positioning balloon are each shown in a contracted or neutral state. [Figure 26] Figure 25 is an exploded side perspective view of a cervical control system according to several embodiments of the present invention. [Figure 27] This is an exploded cross-sectional view of the components of the cervical control system of Figure 25, viewed along the cutting line XXVII-XXVII in Figure 25, according to some embodiments of the present invention. [Figure 28] Another top perspective view of the cervical control system of Figure 25, according to some embodiments of the present invention, with the inner cuff shown in an inflated or expanded state. [Figure 29] This is a cross-sectional side view along the cutting line XXVI-XXVI of Figure 25, showing the inner cuff and positioning balloon, respectively, in a deflated state, according to some embodiments of the present invention. [Figure 30] This is another cross-sectional side view along the cutting line XXVI-XXVI of Figure 25, illustrating the inner cuff in an inflated state and the positioning balloon in a deflated state, according to some embodiments of the present invention. [Figure 31]This is a cross-sectional side view along line XXXI-XXXI in Figure 25, showing the inner cuff and positioning balloon, respectively, in an inflated state, according to some embodiments of the present invention. [Figure 32A] Figure 29 shows a cervical control system according to some embodiments of the present invention, and another cross-sectional side view of a quad-lumen inflation system coupled with a valve system for inflating the internal and / or positioning balloon of the system inserted therein. [Figure 32B] This is an enlarged view of the region indicated by XXXIIA in Figure 32A, according to some embodiments of the present invention. [Figure 32C] Figure 32A shows a side perspective view of a quad lumen according to several embodiments of the present invention. [Figure 33] Figure 25 shows a sagittal view of a patient with a singleton pregnancy, including a cross-sectional side view of a cervical control system in the patient's vagina for supporting the patient's cervix, according to some embodiments of the present invention. [Figure 34] Figure 25 is a radial cross-sectional side view of the inner cuff of the cervical control system according to several embodiments of the present invention. [Figure 35] This is a top view of another cervical control system according to some embodiments of the present invention, in which the internal cuff and positioning balloon are each shown in a contracted or neutral state. [Figure 36] This is a side perspective view of another cervical control system according to some embodiments of the present invention, in which the inner cuff is shown in a contracted or neutral state. [Figure 37] This is a side cross-sectional perspective view of the cervical control system of Figure 36, along line XXXVII-XXXVII in Figure 36, according to some embodiments of the present invention. [Figure 38] This is a radial cross-sectional side view of a first exemplary cleat according to several embodiments of the present invention. [Figure 39] This is a radial cross-sectional side view of a second exemplary cleat according to some embodiments of the present invention. [Figure 40]This is a radial cross-sectional side view of a third exemplary cleat according to several embodiments of the present invention. [Figure 41] This is a radial cross-sectional side view of a fourth exemplary cleat according to several embodiments of the present invention. [Figure 42] This is a radial cross-sectional side view of a fifth exemplary cleat according to some embodiments of the present invention. [Figure 43] This is a front view of a sixth exemplary cleat according to some embodiments of the present invention. [Figure 44] This is a front view of a seventh exemplary cleat according to some embodiments of the present invention. [Figure 45] This is a front view of an eighth exemplary cleat according to several embodiments of the present invention. [Figure 46] This is a front view of a ninth exemplary cleat according to some embodiments of the present invention. [Figure 47] This is a front view of a tenth exemplary cleat according to some embodiments of the present invention. [Figure 48] This is a front view of an eleventh exemplary cleat according to some embodiments of the present invention. [Figure 49] This is a front view of a twelfth exemplary cleat according to some embodiments of the present invention. [Figure 50] This is a front view of a thirteenth exemplary cleat according to some embodiments of the present invention. [Figure 51] This is a side perspective view of another cervical control system according to some embodiments of the present invention, in which the internal cuff and positioning balloon are each shown in a contracted or neutral state. [Figure 52] Figure 51 shows a side cross-sectional perspective view of the cervical control system according to several embodiments of the present invention, along the line LII-LII in Figure 51. [Figure 53] Figure 52 is a side cross-sectional perspective view of a cervical control system according to several embodiments of the present invention, in which the inner cuff is shown in a contracted state and the positioning balloon is shown in an inflated or expanded state. [Figure 54]Figure 53 is another side cross-sectional perspective view illustrating a tube and valve assembly for inflating the upper part and positioning a balloon, according to some embodiments of the present invention. [Figure 55] This is a bottom perspective view of another cervical control system according to some embodiments of the present invention, in which the internal cuff and positioning balloon are shown in a deflated or neutral state. [Figure 56] Figure 55 is a bottom cross-sectional perspective view of a cervical control system according to some embodiments of the present invention, viewed from below and perpendicular to the axis of the inner cuff of the cervical control system. [Figure 57] Figure 55 is a partial cross-sectional upper perspective view along line LVII-LVII, illustrating the internal structure of a cervical control system according to several embodiments of the present invention, with the internal components left as they are. [Figure 58] This is a perspective view of a system including a cervical control system, tubing, and valve system according to some embodiments of the present invention. [Figure 59] Figure 58 is an exploded perspective view of the system according to several embodiments of the present invention. [Figure 60] Figure 58 is a detailed exploded view of the system according to several embodiments of the present invention. [Figure 61A] This is a cross-sectional view of a valve housing including a pressure gauge in a first position, along the cutting lines 61A, 61B, and 61C of Figure 61D, according to some embodiments of the present invention. [Figure 61B] This is a cross-sectional view of a valve housing including a pressure gauge in a second position, along the cutting lines 61A, 61B, and 61C in Figure 61D, according to some embodiments of the present invention. [Figure 61C] This is a cross-sectional view of a valve housing including a pressure gauge in a third position, along the cutting lines 61A, 61B, and 61C in Figure 61D, according to some embodiments of the present invention. [Figure 61D] Figures 61A to 61C show perspective views of a cross-sectional valve housing equipped with a pressure gauge according to several embodiments of the present invention. [Figure 61E] Figure 61D is a side cross-sectional view of a pressure gauge located inside a valve housing according to several embodiments of the present invention. [Figure 62A] This is a perspective view of a cervical control system according to some embodiments of the present invention, which includes an inner cuff and a positioning balloon in a neutral and contracted state, and a valve housing with a syringe inserted into the valve of the valve housing, the valve being associated with the positioning balloon. [Figure 62B] Figure 62A is a side cross-sectional view of a system according to several embodiments of the present invention, showing the fluid communication path from the syringe to the positioning balloon. [Figure 63A] Figure 62A is a perspective view of the system according to some embodiments of the present invention, in which the positioning balloon is in an inflated, pressurized, and / or expanded state. [Figure 63B] This is a cross-sectional view of the system shown in Figure 63A according to some embodiments of the present invention. [Figure 64A] This is a partial cross-sectional view of a cervical control system according to some embodiments of the present invention, in which the internal cuff and positioning balloon are in a neutral or contracted state. [Figure 64B] Figure 64A is a cross-sectional view of a cervical control system according to some embodiments of the present invention, in which the inner cuff is in a neutral or contracted state and the positioning balloon is in an inflated state. [Figure 65A] This is a cross-sectional view of a cervical control system according to some embodiments of the present invention, in which the cervix is ​​positioned within its internal passage and the internal cuff of the cervical control system is in a neutral position. [Figure 65B] Figure 65B is a cross-sectional view of a cervical control system according to some embodiments of the present invention, in which the cervix is ​​positioned within its internal passage and the internal cuff of the cervical control system is in an inflated, expanded, and / or pressurized state. [Figure 66] This is a partial side cross-sectional view of a cervical control system according to some embodiments of the present invention, showing an inner cuff and an internal chamber defined by the flexible membrane of the inner cuff. [Figure 67A] This is a top view of a cervical control system according to some embodiments of the present invention, in which both the internal cuff and the positioning balloon are in a neutral position and the cervix is ​​positioned within its internal passage. [Figure 67B] Figure 67A is a top view of a cervical control system according to some embodiments of the present invention, in which the cervix is ​​positioned within its internal passage, the internal cuff is in a pressurized or expanded state, and the positioning balloon is in a neutral state. [Figure 67C] Figure 67A is a top view of a cervical control system according to some embodiments of the present invention, in which the cervix is ​​positioned within its internal passage and both the internal cuff and the positioning balloon are in a pressurized or expanded state. [Figure 68A] Figures 67A and 67B are top views of a cervical control system according to several embodiments of the present invention. [Figure 68B] This figure shows a 90-degree cross-section of the cervical control system of Figure 68A according to several embodiments of the present invention. [Figure 69A] This is a top view of a valve housing for a single valve according to some embodiments of the present invention. [Figure 69B] This is a bottom perspective view of the valve housing shown in Figure 69A, according to some embodiments of the present invention. [Figure 69C] Figure 69A is a cross-sectional view of a valve housing according to several embodiments of the present invention. [Figure 69D] Figure 69A is a top view of a system including a cervical control system and valve housing according to some embodiments of the present invention. [Figure 69E] This figure shows a cross-section of a first embodiment of the system in Figure 69D, along the cutting line 69E or 69F of Figure 69D, according to some embodiments of the present invention. [Figure 69F] This figure shows a cross-section of a second embodiment of the system in Figure 69D, along the cutting line 69E or 69F of Figure 69D, according to some embodiments of the present invention. [Figure 69G]This is an exploded side view of the system shown in Figure 69E or Figure 69F, according to some embodiments of the present invention. [Figure 69H] This is an assembled side view of the system shown in Figure 69E or Figure 69F, according to some embodiments of the present invention. [Figure 69I] This is a bisecting cross-sectional view of the system shown in Figure 69E or Figure 69F, according to some embodiments of the present invention, in which the expansion source is located together with the valve in the valve housing. [Figure 70A] An exemplary top or proximal view of a cervical control system according to some embodiments of the present invention. [Figure 70B] Figure 70 shows a bottom view or distal view of a cervical control system according to several embodiments of the present invention. [Figure 70C] These are block diagrams representing the cervical control systems shown in Figures 70A and 70B, located in a predetermined position within a patient, according to some embodiments of the present invention. [Figure 71A] This is a bottom perspective view of an exemplary cervical control system including an internal channel, according to some embodiments of the present invention. [Figure 71B] Figure 71A is a cross-sectional view of a cervical control system according to several embodiments of the present invention. [Figure 72A] This is a top view of a triple-port valve housing according to several embodiments of the present invention. [Figure 72B] Figure 72A is a bottom view of a triple-port valve housing according to some embodiments of the present invention. [Figure 73] This is a cross-sectional view of a trilumen tube according to several embodiments of the present invention. [Figure 74A] Figures 71A and 71B show an exploded view of an assembly including a cervical control system, a triple-port valve housing, and a tri-lumen tube, according to several embodiments of the present invention. [Figure 74B] This figure shows an enlarged portion of the exploded view of Figure 74A, according to some embodiments of the present invention. [Figure 74C] This figure shows the fully assembled assembly of Figure 74A according to several embodiments of the present invention. [Figure 75A] Figure 73 is a side exploded view of a system including the cervical control system shown in Figures 71A and 71B, the triport valve housing shown in Figures 72A and 72B, and the trilumen tube shown in Figure 73, according to some embodiments of the present invention. [Figure 75B] This is a rear perspective view of the system shown in Figure 75A, according to some embodiments of the present invention. [Figure 75C] Figure 75A is a rear perspective view of the system when fully assembled with the valves positioned within the valve housing, according to some embodiments of the present invention. [Figure 76A] Figure 72 is a rear-view exploded view of a triple-port valve housing, micropump assembly, and reservoir assembly according to some embodiments of the present invention. [Figure 76B] Figure 76A is a front perspective exploded view of a triple-port valve housing and micropump assembly, according to some embodiments of the present invention, in which the reservoir is located within the micropump assembly. [Figure 76C] Figure 76A is a rear perspective view of an assembly of a triple-port valve housing and micropump assembly, in which the reservoir is located within the micropump assembly, according to some embodiments of the present invention. [Figure 77] This is a side view of an assembly according to several embodiments of the present invention, including the cervical control system shown in Figures 71A and 71B, the triple-port valve housing shown in Figures 72A and 72B, the tri-lumen tube shown in Figure 73, and a syringe. [Figure 78A] This is a bottom view of the top of a mold according to several embodiments of the present invention. [Figure 78B] This is a bottom view of a mold waist according to several embodiments of the present invention. [Figure 78C] This is a top view of the mold waist according to several embodiments of the present invention. [Figure 78D] This is a cross-sectional view of the upper part of the mold along the bisector 78D of Figure 78A, according to some embodiments of the present invention. [Figure 78E] This is a cross-sectional view of the mold waist along the bisector 78E of Figure 78B, according to some embodiments of the present invention. [Figure 78F] This is a top view of a bottom mold according to several embodiments of the present invention. [Figure 78G] This is a cross-sectional view of the bottom mold along the bisector 78G of Figure 78F, according to several embodiments of the present invention. [Figure 78H] This is a bisected cross-sectional view of an assembly comprising the upper mold shown in Figure 78A, the mold waist shown in Figures 78B and 78C, and the bottom mold shown in Figure 78F, according to some embodiments of the present invention. [Figure 78I] Figure 78H is an exploded perspective view of an assembly comprising a molded cervical control system according to several embodiments of the present invention. [Figure 78J] Figure 78I shows a disassembled assembly and a cross-sectional view of a molded cervical control system according to several embodiments of the present invention. [Figure 78K] Figure 78I is a bisected cross-sectional view of a cervical control system according to several embodiments of the present invention. [Figure 78L] Figure 78I is an oblique cross-sectional view of a cervical control system according to several embodiments of the present invention. [Figure 78M] This is a bisected cross-sectional view of a cervical control system with a fully assembled inner cuff, according to several embodiments of the present invention. [Figure 79] This flowchart shows a process for using several embodiments of the present invention, including a cervical control system, a plurality of such systems, and / or a plurality of devices disclosed herein. [Figure 80A] This is a sagittal view of a patient having an intact membrane and a normal amount of amniotic fluid, according to some embodiments of the present invention. [Figure 80B] This is a sagittal view of a patient who experienced PPROM according to some embodiments of the present invention. [Figure 80C] This is a sagittal view of a patient, illustrating how a cervical control system can be positioned with fingers around the patient's cervix according to some embodiments of the present invention. [Figure 80D] This is a sagittal view of a patient, illustrating how, according to some embodiments of the present invention, a cervical control system may be positioned within the patient's vagina and around the patient's cervix using forceps. [Figure 80E] This is a sagittal view of a patient, illustrating how, according to some embodiments of the present invention, the internal cuff and / or positioning balloon of a cervical control system at a given location may be inflated and / or deflated using an inflation medium source in the form of a syringe. [Figure 80F] Figure 80E is a sagittal view of a patient, showing an internal cuff inflated according to some embodiments of the present invention, which consequently engages with the cervix, pressing and closing the cervix. [Figure 80G] Figure 80F is a sagittal view of a patient, showing an internal cuff inflated according to some embodiments of the present invention, which consequently engages with the cervix, tilts the cervix, changes its orientation and angle, and presses against and closes the cervix. [Figure 80H] Figure 80E is a sagittal view of a patient, showing a fluid conduit and valve housing positioned inside the patient's vagina according to some embodiments of the present invention. [Figure 80I] This is a sagittal view of a patient in which the cervical control system is positioned around the cervix in a position inverted from the position shown in Figure 80H, according to some embodiments of the present invention. [Figure 80J] This is a sagittal view of a patient having an intact amniotic membrane and a normal volume of amniotic fluid, according to some embodiments of the present invention. [Figure 80K] This is a sagittal view of a patient with amniotic rupture and some loss of amniotic fluid, according to some embodiments of the present invention. [Figure 80L]Figure 80K is a sagittal view of a patient in which, according to some embodiments of the present invention, the cervical control system is fitted around the cervix, resulting in slowed leakage of amniotic fluid from a ruptured amniotic membrane and recovery. [Figure 81] This is a block diagram of a kit including a cervical control system according to some embodiments of the present invention. [Modes for carrying out the invention]

[0073] With reference to the drawings and the exemplary embodiments illustrated herein, various embodiments of cervical control devices, systems, and methods of use are provided for reducing or preventing premature labor caused, for example, by cervical incompetence (e.g., cervical shortening or cervical insufficiency), prolapse, cervical support, etc. In some embodiments, the cervical control device may be adjustable to apply a compressive force to the outside of the cervix and may function to change the angle of the cervix, thereby potentially promoting a prolongation of fetal gestation in patients experiencing cervical incompetence. The cervical control devices disclosed herein may include one or more expandable (e.g., inflatable) cuffs, one or more expandable cuffs that, when expanded, apply a compressive force to the outside of the cervix. The cervical control device may be adjusted by an operator or user (e.g., a healthcare provider) without removing the cervical control system and / or device from within the patient. In some cases, such as when the cervix is ​​partially dilated and open until the cervical mucus plug falls out, a cervical control system can be used to compress the cervix to promote mucus plug regeneration, thereby preventing infection from moving up the cervix and into the uterus. In cases of PROM or PPROM, a cervical control system can be used to compress the cervix to reduce amniotic fluid loss and help promote fetal lung development. The cervical control systems disclosed herein can be used minimally invasively to provide support around the lower cervix to support the weight of the uterus and fetus, preferably with little or no irritation or inflammation to the cervix (in one embodiment). In other words, the internal and / or positioning balloon can be left in a neutral or undinflated state. If the patient's cervix continues to shorten and dilate, and a minimally invasive approach is not appropriate, the internal balloon and / or positioning balloon may be inflated, or further inflated, to reduce the proximal opening diameter, provide additional support to the lateral cervix, and provide external compressive force to the lateral cervix to prevent further opening or dilation of the cervix.In this specification, the terms “cuff” and “bladder” are used to refer to expansion components of some exemplary embodiments of the present disclosure, which include, for example, an “internal cuff,” a “positioning balloon,” and an “inflatable bladder,” and may be partially or completely annular. Optionally, the internal balloon and / or positioning balloon may be continuous along the inner and / or outer circumference of the cervical control system, or intermittently spaced along the inner and / or outer circumference of the cervical control system, or may expand to define a non-circular or non-uniform opening, and / or may be expandable laterally (e.g., radially) and / or obliquely (e.g., non-radially). In some embodiments, the cervical control systems disclosed herein may be used to support the cervix, uterus, and fetus even when the internal balloon and / or positioning balloon are in a neutral or undinflated state.

[0074] Cervical control devices and systems are disclosed herein that are configured to deliver substances locally to the cervical tissue, in a predetermined location, continuously, as needed, and / or periodically, so that the substances can come into contact with the cervical tissue (e.g., by reapplication), regardless of whether it is for washing away vaginal secretions or other washing of the cervix and vagina. Substances delivered via the cervical control devices and systems disclosed herein include, but are not limited to, drugs such as progesterone, saline, disinfectants, antibiotics, lubricants, water, chlorhexidine, betadine, analgesics, and / or lubricants. The use of the systems and devices disclosed herein allows clinicians to deliver substances to the cervix without removing and reinserting the device and / or system, or irritating the cervix.

[0075] Discussions of the cervical control systems, cervical control devices, and methods disclosed herein use the terms proximal, superior, distal, and / or base to refer to the respective parts of the systems, devices, and methods oriented in each figure, and in many embodiments, the superior and / or proximal parts of the systems and / or devices disclosed herein are intended to be positioned near the patient's fornix with an internal cuff surrounding a portion of the cervix closer to the patient's uterus, and the base and / or distal parts of the cervical control devices and / or systems disclosed herein may refer to parts of the cervical control devices and / or systems configured to be oriented away from the patient's uterus and / or having sides and / or edges closer to the patient's vaginal opening. The systems and devices disclosed herein may be used in various orientations (i.e., orientations not necessarily shown in the figures), and it will be understood that in some cases, parts of the systems and / or devices labeled as proximal or superior may actually be positioned distally within the patient, for example, when inverted to treat pelvic organ prolapse.

[0076] Components of a cervical control system described and shown herein (e.g., an internal cuff and / or positioning balloon) may include one or more flexible membranes (also referred to herein as “walls”) defining one or more internal chambers configured to receive the insertion of an inflatable medium. As the internal chambers of the internal cuff disclosed herein are filled with the inflatable medium, each flexible membrane 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 with, stretch, compress, or otherwise support and / or control the cervix. As the internal chambers of the positioning balloons disclosed herein are filled with the inflation medium, the flexible membranes defining each internal chamber expand in one or more preferred directions (e.g., perpendicular to the main body of the cervical control system and / or into the vagina) to, for example, secure the cervical control system in 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 internal cuffs and positioning balloons disclosed herein are selectively inflatable and / or deflated to adjust, for example, the degree of compression and / or extension of the cervix, the angle of orientation of the cervix and / or the cervical control system, and / or the position and / or orientation of the cervical support device in the vagina, as desired and / or required by the needs and / or preferences of the physician, clinician, and / or patient.

[0077] Returning to the figures, Figures 1 and 2 are sagittal views of a pregnant woman in which an exemplary cervical control system 100 (also referred to herein as "system 100") is positioned within the woman's vagina 103, for example, according to one or more methods disclosed herein, to treat PPROM, cervical shortening, and / or prevent premature labor, resulting in a portion of the woman's cervix 101 being positioned within and supported by the system 100. The internal cuff of the system 100 may be configured to move between a neutral or contracted state (e.g., when the cervix 101 is positioned within it) and an inflated state (e.g., when the cervix 101 is positioned within it and supported and / or reinforced by the system 100). Figure 3 is a top perspective view of the system 100 when the internal cuff is in the contracted or neutral state, and Figure 4 is a top perspective view of the system 100 when the internal cuff is in the inflated state.

[0078] The system 100 includes a flexible body 102 which may have a hemispherical or semi-spherical shape, as shown, for example, in Figures 5 and 6, and an internal passage 170 which has an upper or proximal opening 104 positioned close to the upper portion (in the orientation of Figures 3 to 6) of the body 102 / internal passage 170, and a lower (in the orientation of Figures 3 to 6) or distal opening 106 positioned close to the lower portion (in the orientation of Figures 3 to 6) of the body 102 / internal passage 170. In exemplary embodiments, the diameter of the proximal opening 104 is smaller than that of the distal opening 106, and is sized to receive and surround the lower outer portion of the patient's cervix 101 when the system 100 is positioned near the base of the cervix in the patient's vagina 103, as shown, for example, in Figures 1 and 2. For reference purposes, Figures 16–18 provide illustrations illustrating the positioning of the cervix 101 within an internal passage 470 (similar to the internal passage 170) of another exemplary cervical control system 400, and an example of the interaction between the cervical control system 400 and the cervix 101 when the system 400 is positioned around the cervix 101 and engages 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), which may help, for example, hold the system 100 in place and / or hold the portion of the cervix 101 positioned within the internal passage 170 in a closed position.

[0079] System 100 includes an internal cuff or bladder 108 which may be positioned around the circumference of the proximal opening 104, as shown, for example, in Figures 5 and 6. The outer surface of the internal cuff 108 (e.g., facing the internal passage) is expandable (e.g., expandable with a fluid such as saline or air), and as a result, when the cervix 101 is in place within the internal passage 170 (see, for example, Figures 1 and 2), the internal cuff 108 may expand to engage with a portion of the outer surface of the cervix 101 (e.g., the upper part of the fornix and / or the lower part of the cervix 101), constricting and / or enclosing the portion of the outer surface. The internal cuff 108 is shown in its normal, neutral, or contracted state in Figures 3 and 5, and in its expanded or inflated state in Figures 4 and 6, with a portion of the internal cuff 108 expanded toward the center of the proximal opening 104. In the inflated state, the inner cuff 108 expands and penetrates or impacts the outside of the cervix 101 (or a portion thereof), thereby applying external force or pressure to the cervix 101, which can help close and / or maintain a fully closed state of the cervical opening or cervix, thereby delaying labor and delivery of the fetus and allowing the fetus to remain in the uterus for a longer period of time (i.e., preventing premature labor). When the inner cuff 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 between consecutive Figures 5 and 6, to highlight the relative expansion of the inner cuff 108 from its neutral state in Figures 3 and 5 to its expanded state in Figures 4 and 6, where relative expansion reduces the size or area of ​​the proximal opening 104 and increases the protrusion of the two recesses 110 as shown. The inner cuff 108 may be fixed to the proximal end of the internal passage 170 via mechanical coupling, such as a tongue-and-groove fitting or a dovetail fitting (e.g., chemically, vibratoryly, or thermally joined), integrated (e.g., via an integral molding process or an overmolding process), and / or joined. Further details relating to the manufacture of the system 100 and / or the inner cuff 108 are shown, for example, in Figures 1 to 6 and discussed herein.

[0080] As shown in Figures 3 and 4, the inner cuff 108 comprises two recesses 110 on opposite sides of the proximal opening 104 and two expandable portions 112 formed between the recesses 110 on the other opposite sides of the proximal opening 104. In the neutral state, the inner cuff 108 defines a generally circular shape (see, for example, Figure 3). When the inner cuff 108 expands, the expandable portions 112 expand toward the axis of the proximal opening 104, while the recesses 110 remain substantially stationary, unchanged, and unexpanded, as shown, for example, in Figure 4. Thus, in the expanded state, the recesses 110 and the expandable portions 112 work together to form a non-circular inner circumference of the inner cuff 108 (Figure 4). When the inner cuff 108 is in the expanded state, the area of ​​the proximal opening 104 is reduced compared to its area when the inner cuff 108 is in the neutral state. The recess 110 is positioned within the inner cuff 108 to receive a portion of the cervix 101 (e.g., the end of the cervix) that includes the major blood vessels supplying blood to the cervical tissue, and is configured to contract the cervical tissue to a minimum extent so as not to impair blood flow through these vessels while the rest of the cervical tissue is being compressed by the expansion of the inner cuff 108.

[0081] As shown sequentially in Figures 5 and 6, as the inner cuff 108 expands, it expands radially inward toward the center of the proximal opening 104 and downward (in the orientation of Figure 6) relative to the cross-section of the proximal opening 104. In other words, if the system 100 is positioned in the vagina such that the cervix 101 is located within the internal passage and the inner cuff 108 expands, the expansion of the inner cuff 108 may 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 expansion angle of the inner cuff 108 can act to pull or push the cervix 101 downward away from the uterus 105, which helps to hold the inner cuff 108 in place during use (e.g., to reduce or prevent the cervix from slipping out of the inner cuff 108), which may be caused, for example, by an increase in the volume of the inner cuff during expansion and / or cervical shortening over time. In other words, the combination of lateral and downward constricting forces on the cervix 101 can engage and constrict the outside of the cervix 101 more effectively than if the constricting force were applied laterally or downward only. The expansion angle of the inner cuff 108 away from the cross-section of the proximal opening 104 can be selected from a range of 0.5 degrees (0.5°) to 89.5 degrees (89.5°).

[0082] In some embodiments, the entire inner cuff 108 may be formed of the same material (e.g., flexible silicone), which may optionally have varying thicknesses (e.g., the flexible silicone of the recess 110 is thicker than the flexible silicone of the expandable portion 112). Alternatively, different parts of the inner cuff 108 (e.g., the recess 110 and the expandable portion 112) may be formed from different materials (e.g., the expandable portion 112 may contain flexible silicone, and the recess 110 may contain medical-grade plastic), and / or the different parts 110 and 112 of the inner cuff 108 may be formed from materials of different compositions (e.g., the expandable portion 112 may contain flexible silicone, and the recess 110 may contain semi-rigid silicone having a higher durometer than the silicone of the expandable portion 112).

[0083] In some embodiments, the system 100 includes a raised annular rim, protrusion, or lip 114 (hereinafter referred to as rim 114) located near the upper (in the orientation of Figures 3 to 6) or proximal portion of the body 102. The rim 114 may extend above the inner cuff 108 or may protrude beyond the inner cuff 108 (see, for example, Figures 5 and 6) and may be configured to be positioned toward the uterus 105 when the system 100 is in a given position (see Figures 1 and 2). The rim 114 may define the uppermost or most proximal edge of the system 100 and may include an inclined outer wall 114a extending from the upper part of the rim 114 (in the orientation of Figures 5 and 6) toward the boundary with the outside of the body 102, and an inclined inner wall 114b extending from the upper part of the rim 114 toward the upper edge of the inner cuff 108 (in the orientation of Figures 5 and 6). The inclined inner wall 114b may be configured, sized, and / or shaped to facilitate the entry of the cervix 101 into the proximal opening 104 and the internal passage 170 by funneling or guiding the end of the cervix 101 along the inclined inner wall 114b while positioning the system 100 around the cervix 101 in the vagina 103. The inclined inner wall 114b may be angled, for example, 20 to 85 degrees (20 to 85°) or about 5 degrees (5°) to about 60 degrees (60°) with respect to the longitudinal axis of the system 100 (as represented by the vertically oriented dashed lines superimposed in Figures 5 and 6) so that when positioning the system 100 in place, the cervix 101 may be guided, for example, into the internal passage 170 (see Figures 1 and 2). In some embodiments, the rim 114 may extend 1 to 1 mm above the upper edge (in the orientation shown in Figures 3 to 6) or proximal edge of the inner cuff 108.

[0084] In some embodiments, the system 100 may include an expansion medium conduit 116 configured to communicate fluidly with an inner cuff 108 via an inlet 120. The conduit 116 may be located on the outer surface of the body 102 and / or embedded within the wall 118 of the body 102, as shown in Figures 5 and 6. Fluid introduced into the conduit 116 via the inlet 120 may communicate with the inner cuff 108 and inflate the inner cuff 108, and fluid extracted from the inner cuff 108 via the conduit 116 and the inlet 120 may deflate the inner cuff 108 during use according to one or more methods disclosed herein. The inlet 120 is located on the external portion or outer surface of the body 102 and is therefore accessible by an inflation device (e.g., a syringe or tube) (not shown) for the purpose of adding fluid to the conduit 116 and / or the inner cuff 108 and / or removing fluid from the conduit 116 and / or the inner cuff 108, and / or can be detachably coupled to an inflation device. In this way, the inner cuff 108 can be inflated and / or deflated in place without the need to remove the system 100 from the vagina 103 during treatment. Optionally, a valve (not shown) may be provided in or near the inlet 120 to regulate the flow of fluid in and out of the conduit 116. For example, a Y-valve system such as the 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, an inflatable / deflated device, such as an inflatable / deflated device 827 including a tube 828 and a valve 830 as shown in Figure 32, which will be described in more detail below, may be used to inflate and / or deflate the inner cuff 108.

[0085] In some of the embodiments shown, the internal cuff 108 extends downward or away from the cross-section of the proximal opening. Additionally or alternatively, the internal cuff 108 may extend substantially along the cross-section of the proximal opening, as illustrated, for example, in exemplary embodiments of the cervical control systems 400 and 800, shown in Figures 14–18 and 29–30, respectively, and described in further detail below. For example, the internal cuff 808 may be configured to extend purely radially and concentrically, as illustrated sequentially for system 800 in Figures 29 and 30.

[0086] Figures 7 and 8 provide cross-sectional views of another cervical control system 200, similar to the system 100 described above, but including several alternative and / or additional components and functions. Similar to the components of system 100, system 200 includes a main body 202, a proximal opening 204, a distal opening 206, an inner cuff 208, a raised annular rim 214, an internal passage 270, and an expansion medium conduit 216 within the body wall 220. The cervical control system 200 also includes a plurality of mechanical engagement elements 222, for example, in the form of one or more annular protrusions, cleats, and / or teeth, arranged along the inner surface or periphery of the inner cuff 208, which may extend into the internal passage 270. The mechanical engagement element 222 may be configured to engage with cervical tissue to assist in holding the cervical control system in place and / or to prevent unintended movement of the cervical control system 200 (e.g., detachment from the cervix 101) caused by, 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 vagina 103. In some embodiments, the mechanical engagement element 222 may also be configured to grip the outside of the cervix 101, which may assist in holding the cervix 101 in an extended and / or closed position, and / or reduce or prevent the cervix 101 from slipping out of the inner cuff 208. In some embodiments, the cervical control system 200 may include a plurality of rows of mechanical engagement elements 222, configured such that as the inner cuff 208 expands, the expanded inner cuff 208 directs a compressive force toward the cervix 101, and this compressive force is substantially concentrated on the edge of one or more mechanical engagement elements 222, thereby promoting engagement between the mechanical engagement elements 222 and the cervix 101, and as a result, the inner cuff 208 can be held in place regardless of the coefficient of friction between the cervix 101 and the inner cuff 208.

[0087] In some embodiments, one or more mechanical engagement elements 222 may include a raised or extended portion that continuously encircles the entire inner circumference of the inner cuff 208. Additionally or alternatively, one or more mechanical engagement elements 222 may include individual segments or extended portions, such as segmented cleats, which are positioned along the outer surface of the inner cuff 208, extend from the outer surface of the inner cuff 208, and / or are pushed into the outer surface of the inner cuff 208, as discussed herein and provided by the cervical control systems 1000 and 1100 of Figures 36-37 and 51-54. If the mechanical engagement elements 222 include segmented raised portions, the ends of each raised segment may be chamfered or tapered for comfort and / or to concentrate the compressive force from the inner cuff 208 over a smaller surface area in contact with the cervix 101.

[0088] The mechanical engagement element 222 may extend from the outer surface of the inner cuff 208 by about 0.1 mm to 10 mm and / or be pressed into the outer surface of the inner cuff 208, and in many embodiments, may extend from the outer surface of the inner cuff 208 by about 1.5 to 6 mm or 3 mm and / or be pressed into the outer surface of the inner cuff 208. Sometimes, the mechanical engagement element 222 may be formed during the process for manufacturing the inner cuff 208 and / or be made from the same material as the inner cuff 208 (e.g., flexible silicone) by integrally forming or molding with the inner cuff 208. Additionally or alternatively, the mechanical engagement element 222 may be formed from a different material than the inner cuff 208, for example, a rigid polymer (e.g., polyetheretherketone (PEEK)), silicone with a higher durometer than that used for the inner cuff 208, and / or a semi-flexible metal (e.g., 316L stainless steel). In these embodiments, the mechanical engagement element 222 may be fixed to the outer surface of the inner cuff 208 and / or formed when the inner cuff 208 is formed as part of the manufacturing process of the inner cuff 208 and / or the mechanical engagement element 222. If the mechanical engagement element 222 is formed separately from the inner cuff 208, the mechanical engagement element 222 may be attached to the outer surface of the inner cuff 208 by fastening processes that may, for example, use an overmolding process, bonding (e.g., chemical, thermal, and / or vibratory), and / or mechanical fasteners (e.g., clips or snaps).

[0089] In some embodiments, one or more cervical control systems disclosed herein may include an internal cuff that utilizes various structural and / or geometric features to achieve expansion in a desired direction (e.g., downward) relative to the cross-section of their respective proximal openings, as will be discussed in more detail below. For example, in some embodiments (see, for example, Figures 9 to 13 below and discussion), the internal cuff may be formed with non-uniform wall thickness along its radial cross-section, and upon expansion, the internal cuff may expand in the direction of the thickest portion of the wall (i.e., the desired expansion direction). Continuing this example, the consecutive Figures 12 and 13 illustrate exemplary internal cuff expansion along the desired expansion direction, where the internal cuff expands downward (in the orientation of Figures 9 to 13) at the thickest portion of the internal cuff wall. In embodiments having an internal cuff that forms a non-circular proximal opening, the expanded portion of the inflated internal cuff may utilize non-uniform wall thickness, while the recess may have, for example, a generally uniform wall thickness.

[0090] Figure 9 is a cross-sectional view of a portion of a cervical control system, such as the cervical control system 100 or 200, which includes an exemplary inner cuff 300 having varying wall thicknesses, coupled to the proximal portion of the wall 302 of the cervical control system (such as the system 100 or 200 described above) shown in the cross-sectional view of Figure 9. The inner cuff 300 includes a main inflatable bladder or chamber 303, defined by an upper thin-walled portion and a lower thin-walled portion 304, and a thicker wall or thick-walled portion 306 between the thin-walled portions 304 in the proximal portion of the inner cuff 300. The upper thin-walled portion and the lower thin-walled portion 304 may be substantially parallel to each other and may be substantially parallel to the cross-section (not shown) of a proximal opening formed by the inner cuff 300, such as the proximal openings 104 and 204. If the inner cuff 300 contains flexible silicone, due to the expansion properties of the flexible silicone, the thick-walled portion 306 expands more than the thin-walled portion 304 when the inner cuff 300 expands, and this difference in degree of expansion can effectively expand the cuff 300 in desired expansion directions, both radially toward the center of the proximal opening and downward away from the cross-section of the proximal opening.

[0091] In other words, during expansion, the thin-walled sections 304 can initially expand faster than the thick-walled sections 306 until each of them reaches its maximum expansion. Once the maximum expansion is reached, the thin-walled sections 304 do not expand any further, and the remaining expansion of the inner cuff 300 occurs in the thick-walled sections 306. Examples of wall thicknesses for the inner cuff 300 include thicknesses ranging from approximately 0.01016 cm to 0.1524 cm (0.004 inches to 0.060 inches) (for example, 0.01016 cm to 0.02032 cm (0.004 to 0.008 inches), 0.0127 to 0.0254 cm (0.005 to 0.010 inches), 0.0254 to 0.0381 cm (0.010 to 0.015 inches), 0.0381 to 0.0508 cm (0.015 to 0.020 inches), and 0.0508 to 0.1016 cm (0.020 to 0.040 inches). The thick-walled region 306 includes a thin-walled portion 304 in the range of 0.0508 to 0.1524 cm (0.020 to 0.060 inches), and the thickness of the thick-walled region 306 is in the range of approximately 0.0254 cm to 0.254 cm (0.010 to 0.100 inches) (e.g., 0.0254 to 0.0762 cm, 0.0762 to 0.1778 cm, 0.1778 to 0.254 cm (0.01 to 0.03 inches, 0.03 to 0.07 inches, 0.07 to 0.1 inches), and the overlapping range). In one embodiment, different portions, for example, the thin-walled portion 304 and the thick-walled portion 306, may be formed from silicone having different durometers, which may further facilitate the expansion of the cuff 300 in a desired direction. In some cases, the wall thickness selected for the thin-walled portion 304 and / or the thick-walled portion 306 may depend on the hardness level or durometer of the material used to manufacture the inner cuff 300. For example, if the inner cuff 300 contains silicone, the selected wall thickness may depend on the durometer of the silicone.

[0092] Figures 10A and 10B are cross-sectional views of a portion of a cervical control system, such as a cervical control system 100 or 200, showing another exemplary inner cuff having a different wall thickness 310, coupled to the proximal portion of the wall 312 of the main body of the cervical control system when the inner cuff 310 is in a neutral state (Figure 10A) and an expanded state (Figure 10B). The inner cuff 310 has a similar structure to the cuff 300 and includes a main inflatable bladder or chamber 313, a thin-walled portion 314, and a thick-walled portion 316, which function substantially the same as the corresponding feature portions of the inner cuff 300. The inner cuff 310 also includes a pair of protrusions, cleats, or teeth 318, which are similar in structure and function to the mechanical engagement elements 222 described above for the cervical control system 200 shown in Figures 7 and 8. The inner cuff 310 also includes a pair of buckling wall segments 320 in each thin-walled portion 314 (Figure 10). In the neutral, non-expanded state (see Figure 10A), the buckling wall segments 320 of the inner cuff 310 retain their buckled shape as shown in Figure 10A. When the inner cuff 310 is expanded, the buckling wall segments 320 stretch and flatten to provide an initial expansion of the inner cuff 310 as shown in Figure 10B, which allows the inner cuff 310 to expand both radially toward the center of the proximal opening and downward (in the orientation of Figures 10A and 10B), as shown with respect to the upper 301 and lower 305 (in the orientation of Figures 10A and 10B). When in a neutral state, the angle φ1 between the upper reference line 301 and the upper thin wall portion 314 may be approximately 0 to 6 degrees, and the angle φ2 between the lower reference line 305 and the lower thin wall portion 314 may also be approximately 0 to 6 degrees.

[0093] As the inner cuff 310 expands due to the expansion medium entering and / or being pushed into the inner chamber 313, the buckled wall segment 320 may stretch and / or become substantially flat (or unbuckle), and the remaining expansion of the inner cuff 310 may occur in the thick wall portion 316. Additionally or alternatively, if the inner cuff 310 expands, the angle φ between the upper reference line 301 and the upper thin wall portion 3141’ The angle between the lower reference line 305 and the lower thin wall portion 314 may increase to approximately 3 to 20 degrees or up to 10 degrees. 2’ In one embodiment, a plurality of buckling wall segments are provided at the top of the inner cuff 310 so that it extends downward in a desired direction and / or through a desired displacement as shown, and can vary from -2 to 30 degrees (minus 2 to 30). In some embodiments, a plurality of (e.g., three, four, five, six, or eight) buckling wall segments may allow for further expansion of the inner cuff 310 without the inner cuff reaching the limits of elastic deformation. It will also be recognized that buckling wall segments 320 may be provided only on the upper or lower portion of the inner cuff to allow the inner cuff to expand in a desired direction and / or through a desired displacement.

[0094] Figure 11 is a cross-sectional view of a portion of a cervical control system, such as a cervical control system 100 or 200, including another embodiment of an inner cuff 330 coupled to the proximal portion of the wall 332 of the cervical control system. The inner cuff 330 includes features similar to those of inner cuffs 300 and 310, such as a main inflatable bladder or chamber 333, a thin-walled portion 334, and a thick-walled portion 336, which function substantially the same as the corresponding features of inner cuffs 300 and 310. The inner cuff 330 also includes a first relatively large buckling wall segment 340a located within the upper (in the orientation of Figure 11) first thin-walled portion 334, and a second relatively small buckling wall segment 340b located within the lower thin-walled segment 334. In the neutral, non-expanded state, the first and second buckling wall segments 340a and 340b of the inner cuff 330 retain their buckled shape, as shown in Figure 11. As the inner cuff 330 expands, the buckling wall segments 340a and 340b stretch and flatten. Since the first buckling wall segment 340a is larger than the second buckling wall segment 340b, the first buckling wall segment 340a can be extended to a length longer than the second buckling wall segment 340b, thereby allowing the inner cuff 330 to expand in desired expansion directions, both radially toward the center of the proximal opening and downward away from the cross-section of the proximal opening, as shown in Figure 11.

[0095] Figures 12 and 13 are cross-sectional views of yet another embodiment of a cervical control system, such as the cervical control system 100 or 200, which includes an inner cuff 350 in a neutral or non-expanded configuration and an expanded configuration, respectively. The inner cuff 350 is coupled to the proximal portion of the wall 352 of the cervical control system. The inner cuff 350 includes several feature parts similar to those of the inner cuffs 300 and 310, such as a main inflatable bladder or chamber 353, a thin-walled portion 354, a thick-walled portion 356, a pair of ridges, cleats, or teeth 358 (such as teeth 318 in Figure 10), each of which functions substantially the same as the corresponding feature parts of the cuffs 300 and 310. The inner cuff 350 does not include a buckling wall segment but includes a first inflatable bladder or chamber 360 and a second inflatable bladder or chamber 362. The second inflatable bladder 362 is positioned between the first inflatable bladder 360 and the main inflatable chamber 353, and the first inflatable bladder 360 is positioned between the second inflatable bladder 362 and the wall 352. The first and second inflatable bladders 360 and 362 are adjacent to each other and to the main chamber 353 and are substantially coaxial. The first inflatable bladder 360 is defined as having an elongated trapezoidal cross-sectional shape with two elongated side walls 360a, an upper (in the orientation of Figure 12) wall 360b, and a bottom wall 360c that is shorter than the upper wall 360b. The second inflatable bladder 362 is defined as having an elongated trapezoidal cross-sectional shape with two elongated side walls 362a, an upper (in the orientation of Figure 12) wall 362b, and a bottom wall 362c that is shorter than the upper wall 360b. The relatively longer lengths of the upper walls 360b and 362b compared to the lower walls 360c and 362c act to collectively orient the inner cuff 350 to an initial downward (in the orientation of Figure 12) angle θ1 of approximately 0.5 to 50 degrees relative to the lower (in the orientation of Figure 12) edge of the inner cuff 350, represented by the horizontal dashed line 361 superimposed in Figure 12, which can promote downward expansion of the inner cuff 350. The horizontal dashed line 361 may be parallel to the cross-section of the proximal opening of the cervical control system incorporating the inner cuff 350.

[0096] As the inner cuff 350 is inflated, the first and second bladders 360 and 362 may extend toward the radial center of the proximal opening (represented by the vertically oriented dashed line 363 superimposed in Figures 12 and 13, which is substantially parallel to the radial center of the proximal opening), or they may remain substantially unchanged or not inflated. During inflation, the main chamber 353 extends both radially inward toward the vertically oriented dashed line 363 (i.e., the axis of the proximal opening) and downward at an angle θ2 (e.g., 3 to 50 degrees) with respect to the cross-section of the proximal opening, as represented by the horizontally oriented dashed line 361. The relative radial and downward movement between the inner cuffs 350 in the neutral and inflated states can be viewed with reference to virtual lines 363 and 361 in the vertical and horizontal orientations, respectively, where these virtual lines are in the same position in both Figure 12 and Figure 13, and as a result, relative changes in the position and orientation of the inner cuffs between the inflated and deflated states can be observed. In some embodiments, the first and second bladders 360 and 362 and / or the main chamber 353 may be fluidly connected to each other so that inflation of the inner cuff 350 inflates all three chambers together. Alternatively, the first and second bladders 360 and 362 and / or the main chamber 353 may be individually sealed and fluidly connected to dedicated inflation medium conduits, thereby making the first and second bladders 360 and 362 and / or the main chamber 353 individually addressable (e.g., inflatable or deflated) by the healthcare provider.

[0097] In another embodiment, the inner cuff may have first and second bladders oriented in a different direction than that shown in Figures 12 and 13. For example, in some embodiments, the orientation of the second bladder 362 may be reversed by 180 degrees such that the upper wall 362b is positioned at the lower edge (in the orientation of Figure 12) of the inner cuff and the lower wall 362c is positioned at the upper edge of the inner cuff. In such embodiments, as the first and second bladders of the inner cuff are inflated, the two adjacent upper and lower walls of the first and second bladders can stretch in a sinusoidal manner, which can allow for a greater ability to achieve fine adjustments to the angle θ of the inner cuff with respect to a horizontal imaginary line 361, and as a result, the direction in which compressive force is applied to the cervix can be adjusted for a better and / or more secure fit. In another embodiment, the first bladder 360 may have equal upper and lower wall lengths, while the second bladder 362 has non-uniform upper and lower wall lengths, as shown in Figures 12 and 13. In this embodiment, when the first bladder 360 is inflated, the first bladder may expand substantially radially toward a vertically oriented virtual line 363, and the second bladder may expand both radially inward toward the vertically oriented virtual line 363 (i.e., the axis of the proximal opening) and downward toward the horizontally oriented virtual line 361 (i.e., the cross-section of the proximal opening).

[0098] Figures 14 and 15 provide cross-sectional views of another cervical control system 400 (also referred to herein as "System 400") in a neutral or contracted and inflated state, respectively. The cervical control system 400 is similar to the systems 100 and 200 described above, but includes several alternative components and capabilities and / or additional components and capabilities. Similar to the components of systems 100 and 200, System 400 includes a main body 402, a proximal opening 404, a distal opening 406, an internal passage 470, and an expandable annular internal cuff 408 which may be positioned around the cervix, such as the cervix 101, within a vagina, such as the vagina 103, as shown in the example cervical control system configurations of Figures 1 and 2. The inner cuff 408 also includes a first annular bladder 410 positioned above the second annular bladder 412 (in the orientation shown in Figure 14), and mechanical engagement elements 414 (e.g., annular protrusions, teeth, or cleats) positioned on the outer surfaces of both the first and second annular bladders 410 and 412 as shown. The mechanical engagement elements 414 may be similar to the mechanical engagement elements 222. The mechanical engagement elements 414, the first annular bladder 410, and / or the second annular bladder 412 may be integrally formed (e.g., overmolded) with the upper or proximal portion of the main body 402, and / or formed in conjunction with the proximal portion of the main body 402.

[0099] The first and / or second annular bladder 410 and 412 are individually or collectively addressable and / or inflatable and, in some embodiments, may be configured to inflate proximal (e.g., towards the uterus 105), radially (e.g., towards the internal passage 470), and / or distally (e.g., away from the uterus 105). As shown in Figure 14, in the neutral or uninflated state, the first and second annular bladder 410 and 412 are recessed away from the first and second vertically oriented virtual lines 410a and 401b, and when inflated, both the first and second annular bladder 410 and 412 expand radially toward the first and second vertically oriented virtual lines 410a and 401b, as shown in Figure 15. In one example, the first annular bladder 410 is inflated first, and after the first annular bladder 410 is inflated, the second annular bladder 412 is inflated, and the medial cuff 408 may expand generally in a proximal direction (for example, toward the uterus 105). In another example, the second annular bladder 412 is inflated before the first annular bladder 410, and the medial cuff 408 may expand generally radially inward toward the axis of the proximal opening 404.

[0100] Having two independently inflatable annular bladders, such as the first and second annular bladders 410 and 412, provides greater flexibility in adjusting how the inner cuff 408 is inflated, oriented, positioned, and / or engages with the patient's cervix 101, and as a result, the inner cuff 408 can be adapted to the patient's anatomical structure or the patient's vaginal environment (e.g., to accommodate varying levels of friction within the vagina 103) without the need to manually adjust the position of the system 400 within the vagina, and without the risk of potential irritation to the cervix 101 or the vagina 103, or the introduction of pathogens.

[0101] Figures 16–18 provide exemplary time-series cross-sectional views of how the system 400 may be positioned within the patient's vagina 103 (see, for example, Figures 1 and 2), how the cervix 101 may be positioned within the internal passage 470 of the system 400, and how the inner cuff 408 expands and engages with the cervix 101 to control, compress, and / or support the cervix 101, for example, by reducing the size of the cervical opening 471. Figures 16–18 include first and second vertically oriented imaginary lines 401a and 410b in the same positions as shown in Figures 15 and 16, so that comparisons between the figures may be made easily. In particular, Figure 16 is a cross-sectional view of a portion of the cervix 101 that is expanded with the opening 471a positioned within the proximal opening 404 so that the lower side of the cervix 101 (in the orientation of Figure 16) is aligned with the lower edge of the inner cuff 408. As the fitting procedure of system 400 continues, the cervix 101 is further inserted into the internal passage 470, as shown in Figure 17. The internal cuff 408 is in a neutral or uninflated state in Figures 16 and 17. When the cervix 101 is in place (e.g., fully inserted into the internal passage 470), the first and second annular bladder 410 and 412 may be inflated (as described above with respect to Figure 15) to extend to the first and second vertically oriented imaginary lines 401a and 401b, applying a compressive force that constricts the cervix 101, beginning to close the cervical opening and / or reducing its size to the closed configuration 471b, as shown in Figure 18. In some cases, the first annular bladder 410 may be inflated before the second annular bladder 412, and this initial inflatation of the first annular bladder 410 can apply a force perpendicular to the cross-section of the proximal opening 404 to the cervix 101, in other words, a substantially upward force toward the uterus 105, which can displace more cervical tissue, as shown in Figure 18, thereby pushing the cervical tissue toward the proximal opening 404 and downward into the internal passage 470.Additionally, or alternatively, if the first annular bladder 410 and the second annular bladder 412 are inflated as shown in Figure 18, the mechanical engagement element 414 penetrates and engages with the outside of the cervix 101 as shown, thereby holding the system 400 in place.

[0102] In some embodiments, the cervical control system may include an externally expandable positioning balloon configured to expand into and / or engage with the vaginal wall when inflated and in a predetermined position. These externally expandable positioning balloons can, for example, orient the cervical control system within the vagina to properly and / or optimally receive the insertion and / or engagement of the cervix, and / or hold the cervical control system in place around the cervix within the vagina.

[0103] Figures 19 and 20 provide cross-sectional views of another exemplary cervical control system 500, which includes an expandable annular internal cuff 508 (also referred to herein as the “internal cuff 508”), and which may include components and functionality similar to those of the systems 100, 200, and 400 described above. The system 500 includes a main body 502, a proximal opening 504, a distal opening 506, and an internal passage 570. The internal cuff 508 of the system 500 also includes a recess 510, an expandable portion 512, and a first inflation medium conduit 516a configured to fluidize the internal cuff 508 via a port 520, as described herein. The port 520 also fluidize the external distal cuff 518 (also referred to herein as the “positioning balloon 518”) via a second inflation medium conduit 516b. The recess 510 may be the same as the recess 110, and the expandable portion 512 may be the same as the expandable portion 112 (see, for example, Figures 3 and 4). The positioning balloon 518 may be sized, positioned, and / or configured to expand into the vaginal wall 103 and engage with the vaginal wall 103 to hold the system 500 in a desired position and / or orientation around the cervix 101 and / or vagina 103. In one embodiment, the positioning balloon 518 may include a structure and function similar to the internal cuffs 108, 208, 300, 310, 330, 350, and / or 408 described above, for example, buckling wall portions 320, 304a, or 340b (Figures 10 and 11), non-uniform wall thickness as shown in internal cuffs 300, 310, 330, and 350 (Figures 9 to 13), and / or two or more bladders as shown in internal cuff 350 (Figures 12 and 13), as well as internal cuff 408 (Figures 14 to 18), etc. During inflation, the positioning balloon 518 expands outward away from the axis of the distal opening 506, and therefore toward the vaginal wall 103. The outward expansion of the positioning balloon 518 is shown in the consecutive Figures 19 and 20, with dashed lines added to more clearly illustrate the relative movement of the positioning balloon 518 in the expanded state shown in Figure 20 to its neutral state shown in Figure 19.

[0104] Some embodiments of the expandable cuff system or cervical control system 600 are shown in Figures 21 and 22 and are coupled to the distal portion and / or outside of the wall 602 of a cervical control system (such as the systems 100, 200, 400, or 500 described above). The internal cuff system 600 includes a pair of expandable annular bladders or chambers, including a first or radial bladder 604 and a second or transverse bladder 606. The radial bladder 604 is positioned around the outer circumference of the distal portion of the body 602, and the transverse bladder is positioned along the distal end of the body 602. When expanded, the radial bladder 604 expands outward away from the axis of the distal opening 608 of the system 600 in order to extend into the vaginal wall when in place. When expanded, the transverse bladder 606 expands downward away from the distal end of the body 602. In other words, the transverse bladder 606 expands in the opposite direction to the uterus 105. A dashed line is provided between the consecutive Figures 21 and 22 to more clearly illustrate the relative expansion of the transverse bladder 606 from its neutral state in Figure 21 to its expanded state in Figure 22. In its expanded state, the transverse bladder 606 results in an increase in the overall length of the system 600, which may allow the healthcare provider to adapt to the patient's anatomical structure, and / or to further engage with the cervix 101 via an internal cuff (such as the internal cuff disclosed herein) positioned at the upper or proximal end of the wall 602, and / or to provide additional control and / or support of the cervix 101 and / or the uterus 105.

[0105] In some embodiments, one or both of the radial bladder 604 or the transverse bladder 606 may include structures and functions similar to those of the cuffs 108, 208, 300, 310, 330, 350, 408, 508 and / or 518 described above, for example, buckling wall portions 320, 304a, or 340b (Figures 10 and 11), non-uniform wall thickness as shown in the inner cuffs 300, 310, 330, and 350 (Figures 9-13), and / or two or more smaller bladders as shown in the inner cuffs 350 and 408 (Figures 12-13 and 14-18, respectively). Although the cuff system 600 is shown having two bladders 604 and 606, in one embodiment, a single bladder or chamber may provide sufficient engagement with the vaginal wall while also increasing the overall length of the system 600. For example, an expansion element may be provided along a specific wall of a single bladder to provide expansion in a desired direction. It is envisioned that the system 600 (and any of the aforementioned or later embodiments of the cervical control system) may be positioned in a patient in an inverted position, with its distal end facing and engaging with the cervix 101 to support the cervix and uterus 105. In the opposite orientation, the positioning balloon of the cervical control device may be positioned in contact with the upper vaginal wall and fornix region (e.g., the upper part of the vagina extending into a recess formed between the vaginal wall and the outer part of the lower portion of the cervix), thereby allowing the positioning balloon to provide support to the uterus 105 at the location where prolapse typically occurs as the positioning balloon expands. In embodiments in which the positioning balloon expands laterally, the positioning balloon distributes the load on the uterus 105 over a larger surface area along the vaginal wall (compared to a standard orientation-oriented cervical control system where the inner cuff is directed toward the uterus), which may reduce the risk of medical complications such as pressure ulcers and / or necrosis. In embodiments in which the positioning balloon expands both laterally and away from the main body (for example, toward the uterus 105), the positioning balloon can provide upward support (which may be customized as needed) to the uterus while distributing the load of the uterus 105 over a larger surface area.

[0106] Figures 23 and 24 provide top and bottom perspective views, respectively, of another embodiment of a cervical control system 700, which includes a body similar to or substantially identical to the cervical control system 100 described herein and shown in Figures 1 to 6. Like system 100, system 700 includes a body 702, a proximal opening 704, a distal opening 706, an internal cuff 708, a recess 710, an expandable portion 712, an inflation medium conduit 716, and an inlet 720, which are configured and / or may function, for example, to correspond to the body 102, proximal opening 104, distal opening 106, internal cuff 108, recess 110, expandable portion 112, inflation medium conduit 116, and inlet 120 of system 100, respectively. System 700 also includes an internal relief notch 722a and an external relief notch 722b located on the inner and outer surfaces, respectively, of the body 702. Internal and external relief notches 722a and 722b substantially extend between the distal end of the body 702 and the internal cuff 708 and may be configured to expand and / or provide increased flexibility of the body 702, which may facilitate crushing or folding the system 700 before insertion into and / or withdrawal from the patient's vagina. For example, a healthcare provider may be able to fold the cervical control system so that it forms an anterior edge or tip with a reduced cross-sectional area to protrude more easily through the vaginal opening. In addition to assisting insertion, notches 722a and 722b may also provide a visual indicator of which side is intended for initial insertion into the patient.

[0107] Figures 25 to 34 provide various diagrams of another exemplary cervical control system 800 (also referred to herein as "System 800") which may have several feature parts, components and / or functionalities, comprising one or more of the cervical control systems and / or cervical control system components disclosed herein. In particular, 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 exploded cross-sectional view of System 800; Figure 28 provides a top perspective view of System 800 in an expanded state; Figure 29 is a cross-sectional view of System 800 with the inner cuff 808 and positioning balloon 818 in a neutral, non-expanded state; and Figure 30 shows the inner cuff 808 in an expanded or inflated state and the positioning balloon 818 in a neutral, non-expanded state. Figure 31 is a cross-sectional view of the system 800 in an expanded state, Figure 32A is a cross-sectional view of the system 800 with the inner cuff 808 and positioning balloon 818 in an expanded or inflated state, Figure 32A is a cross-sectional view of the system 800 coupled to an inflation medium source, Figure 32B is a detailed view of a part of Figure 32A, Figure 32C is an enlarged view of a part of the inflation medium source, Figure 33 is a sagittal view of a pregnant woman with the system 800 in a predetermined position, and Figure 34 is an enlarged view of a part of the system 800.

[0108] The system 800 includes a main body 802, a proximal opening 804, a distal opening 806, an internal passage 870, an expandable annular internal cuff 808 (also referred to herein as “internal cuff 808”) located near the proximal opening 804, and an expansion medium conduit 816 (Figures 29 and 30). The internal cuff 808 includes three recesses 810 and three expandable portions 812, which are uniformly distributed around the proximal portion of the body 802 and define the proximal opening 804, and is best illustrated in Figure 28.

[0109] System 800 also includes an external expandable annular cuff or cuff system 818 (also referred to herein as the “positioning balloon 818”) positioned near the distal opening 806. The positioning balloon 818 may be configured and / or operable to expand distally away from the distal end of the body 802 and away from the uterus 105 when inflated in a given position. The positioning balloon 818 may include one or more expandable bladder or bladder segments. In the embodiments shown in Figures 25 to 33, the positioning balloon 818 includes, but is not necessarily, three expandable bladder segments 818a arranged evenly spaced along the circumference of the distal end of the body 802 (see, for example, Figure 26). For example, the positioning balloon 818 may include more (e.g., 4 to 8) or fewer (e.g., 2) expandable bladder segments, or the positioning balloon 818 may be formed of a single continuous, uninterrupted bladder. Figure 29 illustrates system 800 in which the inner cuff 808 and positioning balloon 818 are each in a neutral or undinflated state; Figure 30 illustrates system 800 in which the inner cuff 808 is in an inflated or expanded state and the positioning balloon 818 is in a neutral or undinflated state; and Figure 31 illustrates system 800 in which the inner cuff 808 and positioning balloon 818 are each in an inflated or expanded state. Each of the inflatable bladder segments 818a is selectively and / or individually inflatable, and an example of selective inflation of a bladder 818a is shown in Figure 33, in which one of the bladder 818a of the positioning balloon 818 (positioned toward the posterior end of the patient) is inflated more than the other two bladder 818a.

[0110] During inflation, the inner cuff 808 expands substantially inward toward the axis of the proximal opening 804, as shown in Figures 30 and 31, where dashed lines have been added to more clearly illustrate the relative expansion of the inner cuff 808 as it transitions from a neutral state (Figure 29) to the expanded state shown in Figure 30. During inflation, the positioning balloon 818 and / or inflatable segment 818a expand both inward toward the axis of the distal opening 806 and outward toward the axis of the distal opening 806, and thus toward the vagina, as shown consecutively in Figures 30 and 31, where dashed lines have been added to more clearly illustrate the relative change in size when in the expanded state shown in Figure 31 compared to its neutral state as shown in Figure 30.

[0111] For example, as shown in Figures 26, 27, 29-32, the system 800 includes a lumen ring 822 positioned between the distal end of the main body 802 and the positioning balloon 818. The lumen ring 822 includes a plurality of channels 824 that are open and configured to provide fluid communication between the bladder segment 818a, the expansion medium conduit 816, and the inlet 820. When the system 800 is fully assembled with the lumen ring 822 positioned between the body 802 and the positioning balloon 808, the channels 824 form a plurality of closed lumens (for example, as shown in Figures 29-32), with the distal side of the body 802 forming the ceiling of the closed lumens. Each of the multiple channels can be in fluid communication with the opening port 827 of the inlet 820 (see Figure 32B) and the inflatable segment 818a of the positioning balloon 810. As a result, in some embodiments, each individual inflatable bladder 818a opens into a single lumen, the other end of the lumen opens into a separate port 827, and in this way, the expansion and contraction of each inflatable bladder segment 818a can be individually controlled by the insertion and / or extraction of fluid from the lumen and / or port 827.

[0112] The inlet 820 may be configured to work with a multi-lumen inflatable medium delivery device 801, an example of which is shown in Figures 32A–32C. The multi-lumen inflatable medium delivery device 801 includes a multi-lumen tube 828 and an end cap 829 extending therefrom, which includes four one-way valves 830 (e.g., check valves, one-way duckbill valves, etc.). One-way valves 830 can be sized, configured, and positioned on end caps so that they can be inserted into each port 827 of the inlet 820 to deliver and / or extract inflation medium to and from the channel 824, inflatable bladder segment 818a, inner cuff 808, and / or positioning balloon 818, thereby allowing the inflation / deflation of each inflatable bladder segment 818a, inner cuff 808, and / or positioning balloon 818 to be individually controlled, thereby allowing these components to be inflated and / or deflated as needed, and enabling the system 800 to fit and secure properly within the patient's vagina 103 and around the cervix 101 so that the cervix 101 can be controlled. The ability to address each of the bladders 808 and 818a may enable a healthcare provider to orient or reposition the cervix 101 in a specific manner, for example, to close the cervix 101, to keep the cervix 101 closed, to reduce pressure on the cervix, and / or to stabilize the cervix 101. For example, a healthcare provider may orient the system 800 by selectively inflating one or more of the positioning balloon bladders 818a. For example, in Figure 33, the bladder segment 818a positioned on the posterior side of the patient is inflated more than the bladder segment 818a positioned on the anterior side of the patient, and as a result, for example, the system 800 may be pushed toward the front of the patient.

[0113] The lumen within tube 828 can provide a passage for items to be delivered to system 800, for example, nitinol wire, springs, electrical wiring, or pharmaceuticals / medicines may be passed through tube 828 to system 800. Tube 828 may be detachably coupled to system 800, thereby allowing the patient to move more easily, or tube 828 may be permanently coupled to the cervical delivery system, with the tube remaining inside the patient and / or extending outside the vagina 103.

[0114] In some embodiments, the inner cuff 808 includes upper and lower thin-walled portions 832 and a thicker or thicker-walled portion 834 in the proximal portion of the inner cuff 808 between the upper and lower thin-walled portions 832, which is most clearly visible in Figure 34. In these embodiments, the inner cuff 808 is coupled to the proximal end of the body 802 by teeth 836 that engage with grooves 838 formed in the proximal end of the body 802. The thin-walled portion 832 and the thicker-walled portion 834 are shown in Figure 9 and function similarly to portions 304 and 306 of the inner cuff 300 described above.

[0115] 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 having an asymmetrical and non-circular or non-spherical body 902. Like the systems 100, 200, 400, 500, 700, and 800, system 900 includes a main body 902, a proximal opening 904, a distal opening (not shown), an expandable annular inner cuff 908 positioned near the proximal opening 904, and an expandable annular positioning balloon 918 positioned near the distal opening, with two or more expandable bladder segments 918a defining the positioning balloon 918. The asymmetrical shape of the main body 902 may result in improved engagement with the vagina 103, for example, by occupying space near the cervix 101 within the similarly asymmetrically shaped vagina 103, thereby limiting or prohibiting rotation of system 900 within the vagina 103.

[0116] Figures 36 and 37 provide a top perspective view and a cross-sectional view, respectively, of another cervical control system 1000. System 1000 is similar to systems 100 and 200 described above and shown in Figures 1-6 and 7-8, respectively, and includes a main body 1002, an expandable annular cuff 1008 with a proximal opening 1004, a distal opening 1006, a recess 1010 and an expandable portion 1012, an internal passage 1070, and a pair of raised annular rim segments 1014. Cervical control system 1000 also includes an array of mechanical engagement mechanisms 1016 in the form of, for example, raised portions, cleats, and / or teeth (collectively referred to herein as “cleats”), the array of mechanical engagement mechanisms 1016 may be similar to cleats 222 located on the outer surface of the expandable portion 1012. Cleats 222 may be arranged in rows, columns, offset rows, and / or offset columns along a portion of the inner surface of the expandable portion 1012 of the inner cuff 1008. Cleats 1016 are configured to grip the outside of the cervix 101 when the system 1000 is in place, thereby enhancing the engagement between the system 1000 and the cervix when positioned within the internal passage 1070, and / or providing additional grip to hold the cervix 1000 in an elongated closed position, thereby mitigating or preventing unintended movement between the system 1000 and the cervix 101 (e.g., the cervix 101 slipping out of the inner cuff 1008). Cleats 1016 may be formed together with the outer wall and / or expandable portion 1012 of the inner cuff 1008, for example, by an extrusion process, a molding process, and / or an overmolding process. It is conceivable that the wall thickness of each cleat 1016, or of the inner cuff 1008 adjacent to each cleat 1016, may be modified to allow the cleat 1016 to extend outward relative to the inner cuff 1008, such that the cleat 1016 protrudes beyond the outer surface of the inner cuff wall when the inner cuff 1008 is in an expanded state, compared to when the inner cuff 1008 is in a neutral state.The annular rim segment 1014 may be sized and positioned, as shown in the figure, to extend from the proximal portion of the body 1002 corresponding to and / or near the expandable portion 1012, and not to extend from the proximal portion of the body 1002 corresponding to and / or near the recess 1010. In this way, the annular rim segment 1014 may be sized and positioned so as not to correspond to the location of the cervical blood vessels located within the internal passage 1070, and therefore will not constrict these vessels or obstruct blood flow through them.

[0117] Figures 38–42 provide radial profile diagrams of various exemplary cleats 1016a–1016e, respectively. For reference purposes, Figures 38–42 also provide virtual arrows alongside each radial cleat profile 1016a–1016e to indicate the distal direction of the cervical control system in which each cleat 1016 may reside. In some embodiments, the height of the cleat 1016 (e.g., the distance the cleat 1016 protrudes from the medial cuff wall) may range, for example, from about 100 micrometers (100 μm) to 1500 micrometers (1500 μm). The length of the exemplary cleat 1016 (e.g., the distance between the upper and lower edges of the cleat 1016 (in the orientation of Figures 38–42)) may range from about 100 micrometers (100 μm) to 1500 micrometers (1500 μm). In some embodiments, the various forms of the cleat profiles 1016a to 1016e in Figures 38 to 42 may be molded or formed from the same material as the inner cuff 1008, or the cleat may be formed from a different material or a material of different hardness, such as silicone or plastic that is harder than the silicone of the inner cuff 1008, and later fixed to the inner cuff 1008 by any suitable means (e.g., chemical bonding and / or thermal bonding). For manufacturing purposes, it may be more preferable that the cleat 1016 be formed from the same elastic material as the inner cuff 1008. The cleat 1016 may be individually configured to act or function as a suction cup (see, for example, cleat 1016a in Figure 38) to form a vacuum engagement with the tissue outside the cervix 101 and / or form a projection configured to protrude and engage with the outside of the cervix 101. As shown in Figures 38 to 42, the cleat profiles 1016a, 1016b, 1016c, 1016d, and 1016e are shown as solids.However, in one embodiment, the cleats 1016 may be formed with a gap between them and the inner cuff wall, or the cleats 1016 may be formed with a gap leading to the inner cuff 1008 so that as the inner cuff is inflated, the gap within the cleats 1016 is inflated or expanded, thereby expanding the size and / or shape of each cleat 1016. As shown in Figure 39, the cleat 1016b has an extension with a curved lower profile configured to protrude into the cervical tissue and hook onto the cervical tissue, as shown in Figure 41, the cleat 1016c has a projection with a rectangular profile, as shown in Figure 42, the cleat 1016d has a projection with a truncated trapezoidal profile, and as shown in Figure 42, the cleat 1016e may be formed such that its downward-facing edge / tip 1017 forms an acute angle with the outer wall of the inner cuff 1008. This configuration effectively functions as a hook to grasp and hold the cervical tissue, thus resulting in improved engagement with the cervical tissue.

[0118] Figures 43–50 show front and elevation views of various cleats 1016f–1016m. For reference purposes, Figures 43–50 also provide virtual arrows next to each cleat 1016f–1016m to indicate the distal direction of the cervical control system in which each cleat 1016f–1016m may reside. Any of the cleat shapes 1016f–1016m (in addition to other suitable cleat shapes) can be used in conjunction with any of the cleat profiles 1016a–1016e (in addition to other suitable cleat profiles) to form a desired cleat 1016 for integration into a cervical control system such as a cervical control device and / or an internal cuff, and / or for engagement with the cervix 101, as disclosed herein. The cleat shape 1016f illustrated in Figure 43 is circular and may have a diameter ranging, for example, from approximately 50 micrometers (50 μm) to 2000 micrometers (2000 μm). Figures 44 to 49 show non-circular cleat shapes 1016g to 1016l, respectively, which may have overall height and width dimensions ranging, for example, from 25 micrometers (25 μm) to 2500 micrometers (2500 μm). In particular, Figure 44 shows a rectangular cleat 1016g, Figure 45 shows a trapezoidal cleat 1016h, Figure 44 shows an inverted trapezoidal cleat 1016i, Figure 47 shows a truncated triangular cleat 1016j, and Figure 48 shows an inverted truncated triangular cleat 1016k. Figures 49 and 50 show additional geometric cleat shapes 1016l and 1016m, respectively, extending outward from the inner cuff wall 1008 to the tip or apex 1019 and 1021. The cleat shape 1016l in Figure 49 is generally pyramidal, and in the illustrated embodiment, it is an oblique pyramid with the apex 1019 offset downwards. The cleat shape 1016m is generally conical, and in the illustrated embodiment, it is an oblique cone with the apex 1019 offset downwards.

[0119] Figures 51 to 54 provide various diagrams of another cervical control system 1100 (also referred to herein as "System 1100"). In particular, 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 position, Figure 53 provides a cross-sectional view of System 1100 when the positioning balloon 1118 is in an inflated position, and Figure 54 provides a cross-sectional view of System 1100 when the positioning balloon 1118 is in an inflated position and System 1100 is coupled and / or integrated with an inflation medium source. Similar to the components of systems 100, 500, and 1000 as described above and shown in Figures 1-6, 19-20, and 36-37, respectively, system 1100 includes a main body 1102, a proximal opening 1104, a distal opening 1106, an expandable annular inner cuff 1108 (also referred to herein as the “inner cuff 1108”) having a recess 1110 and an expandable portion 1112, an internal passage 1170, and a raised annular rim 1114. In further similarity to the components of system 500, system 1100 includes an external or distal expandable annular cuff 1118 (also referred to herein as the “positioning balloon 1118”) located near the distal opening 1106 on the outside of the main body 1102. In further similarity to the components of system 1000, system 1100 includes an array of cleats or teeth 1116 disposed around the outer surface of the expandable portion 1112 of the inner cuff 1108 and extending therefrom. The cleats 1116 are shown in Figures 38 to 50 and may be similar in shape and / or function to the cleats 1016 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 extends further up the wall of the body 1102 of system 1100 than the positioning balloon 518 extends to the body 502.

[0120] Various embodiments of the positioning balloon 1118 may extend, for example, to half the outer wall of the body 1102, or to substantially the entire length of the outer wall of the body 1102. Increasing the size of the positioning balloon 1118 increases the contact area between the positioning balloon 1118 and the patient's vagina 103, providing greater stability to the system 1100 when the system 1100 is in a predetermined position, and improving support and / or control of the patient's cervix 101 and / or uterus 105. The positioning balloon 1108 may include a single bladder, or multiple bladders (e.g., 2 to 8), such as the bladder 818a of the positioning balloon 818 described above and shown in Figures 25 to 31.

[0121] Furthermore, compared to system 1000, the cleat 1116 of the cervical control system 1100 is significantly larger than the cleat 1016 of system 1000, and fewer cleats 1116 are provided on the inner circumference of the expandable portion 1112. Like the cleat 1016, the cleat 1116 may be configured to engage with the cervical tissue (e.g., by pushing in and / or adhering to the cervical tissue) after insertion of the cervix 101 into the internal passage 1170 and inflation of the inner cuff 1108 and / or expandable portion 1112, to provide additional gripping and attempt to pull and / or hold the cervix 101 in an elongated closed state (see, for example, Figure 18), thereby mitigating or preventing the cervix 101 from slipping out of the inner cuff 1108. The cleat 1116 may be formed together with the outer wall of the inner cuff 1108 by, for example, an extrusion process, a molding process, or an overmolding process. Sometimes, the wall thickness of each cleat 1116, or of the inner cuff 1108 adjacent to each cleat 1116, may be modified, for example, to allow the cleat 1116 to extend outward relative to the inner cuff 1108, so that when the expandable portion 1112 is in an expanded state compared to when the expandable portion 1112 is in a neutral state, the cleat 1116 protrudes beyond the outer surface of the expandable portion 1112.

[0122] Similar to the arrangement of the teeth 836 of the inner cuff 808 and the groove 838 in the wall of the body 802 of the system 800 as described above and shown in Figures 25 to 31, the inner cuff 1108 is coupled to the proximal end of the wall of the body 1102 by teeth 1136, which fit into the proximal end of the body 1102 and engage with grooves 1138 located on the upper and lower sides (in the orientation of Figure 52) of the proximal end of the wall, as shown in Figures 52 to 54. The body 1102 also has distal positioning grooves 1142 and central positioning grooves 1142 located on the outer surface of the body 1102, which are sized, configured, and positioned to receive the distal and proximal teeth 1140 of the positioning balloon 1118, thereby enabling the attachment of the positioning balloon 1118 to the body 1102 as shown in Figures 52 to 54. The teeth 1136 and / or 1140 can be fixed within the grooves 1138 and / or 1142 by any acceptable means, including but not limited to chemical bonding, mechanical bonding, thermal bonding, and vibration bonding.

[0123] As can be seen in Figure 54, system 1100 includes a first expansion medium conduit 1144 and a second expansion medium conduit 1146, both of which are in fluid communication with the inner cuff 1108 and the positioning balloon 1118, respectively. The expansion medium conduits 1144 and 1146 are structurally and functionally similar to the expansion medium conduits 116, 216, 516, and 816 of systems 100, 200, 500, and 800, respectively (see, for example, Figures 5 and 6, 7 and 8, 19 and 20, and 29 and 30, respectively). As shown in Figure 54, the expansion medium conduits 1144 and 1146 are dedicated to the corresponding cuffs 1108 and 1118, respectively, and extend within the body 1102, so that their first ends open to the inner cuff 1108 and positioning balloon 1118, and their second ends extend away from the body 1102 and remain within the tube 1148 (e.g., a multi-lumen catheter) until the distal end of the tube 1148 terminates in the valve system 1150, the valve system 1150 which may be functionally similar to the valve system 826 described above and shown in Figures 29-30.

[0124] The valve system 1150 includes a first valve 1152 communicating with a first conduit 1144 and a second valve 1154 communicating with a second conduit 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. The tube 1148 may be configured to extend from the system 1100 to the patient's cervix 101, through the vagina 103, and to extend outward to a sufficiently far distance from the vaginal opening (e.g., 5.08–60.96 cm (2–24 inches)), so that a clinician can access and utilize the valve system 1150 for introducing and / or withdrawing inflation medium to and from the inner cuff 1108 and / or positioning balloon 1118 without, for example, removing or repositioning the system 1100 from the cervix 101 and / or vagina 103. Making the first valve 1152 and / or the second valve 1154 accessible outside 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 conduit and / or second conduit and / or cervical control system 1000 during use. Additionally or alternatively, positioning the first valve 1152 and / or the second valve 1154 so that they may be outside the vagina during use allows the healthcare provider to release pressure in the conduits 1144 and 1146 and cuffs 1108 and 1118 simply by breaking the pressure seal, which, if not released, would be trapped due to the function of the one-way valves 1152 and 1154. For example, a commonly known or commercially available device, such as a locking needle or syringe tip coupled to tube 1148, may be used to allow the healthcare provider to easily break the pressure seal. The healthcare provider can break the pressure seal by removing the valve system 1150 from the tube 1148.

[0125] Figures 55–57 provide various diagrams of another cervical control system 1200 (also referred to herein as “System 1200”), where Figure 55 is a bottom perspective view; Figure 56 is a cross-sectional bottom perspective view of System 1200, with the distal end removed, thereby showing the size, shape, and location of the fluid reservoir 1240; and Figure 57 is a section view of System 1200. System 1200 includes several components similar to those of System 1100 and other cervical control systems disclosed herein. For example, system 1200 includes a main body 1202, an expandable annular internal cuff 1208 (also referred to herein as “internal cuff 1208”) including a proximal opening 1204, a distal opening 1206, an internal passage 1270, a recess 1210, an expandable portion 1212, an array of cleats or teeth 1216 disposed and positioned on the outer surface of the expandable portion 1212 of the internal cuff 1208, and teeth 1236 sized, configured, and positioned to fit into and engage with grooves 1238 formed on the upper and lower parts (in the orientation of Figure 57) of the proximal end of the main body 1201, as shown in Figure 57. System 1200 also includes an optional distal external expandable element 1255 configured to receive an expansion medium when system 1200 is in a predetermined position and to expand outward toward the vaginal wall.

[0126] System 1200 further includes a fluid reservoir 1240 (Figures 56 and 57) located within the wall of the body 1202 and in fluid communication with an inner cuff 1208 and a valve system (not shown) having an inlet port 1241 (Figure 55). The inlet port 1241 may be, for example, a one-way valve as described above for systems 800 and 1100, and / or a duckbill valve configured to allow air to pass through in order to transfer an expansion medium from the fluid reservoir 1240 to the inner cuff 1208 and / or to reach an equilibrium state (e.g., not a vacuum) within the fluid reservoir 1240. System 1200 further includes a component cavity 1242 located within another portion of the wall of the body 1202 adjacent to the fluid reservoir 1240 (Figure 56). The component cavity 1242 is located inside the wall of the main body 1202 and is sized and configured to provide space for housing an internal fluid pump 1244, which is in fluid communication with the fluid reservoir 1240 via a first conduit 1246 and in fluid communication with the inner cuff 1208 via a second conduit 1248 (Figure 57). The pump 1244 may be configured and / or operable to move fluid from the fluid reservoir 1240 to one or more portions of the inner cuff 1208, thereby inflating and / or deflating the inner cuff 1208. In some embodiments, the inlet port 1241 may be a vent configured to allow air movement to counteract the vacuum generated during the operation of the pump 1244.

[0127] A controller or computer 1250 is electronically coupled to the pump 1244 and may be configured to execute one or more commands 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 be enabled to perform wireless communication / control, thereby allowing a healthcare provider to remotely inflate / deflate the internal cuff 1208 without invasive procedures to access the system 1200, and thus enabling the cervical control system 1200 to be a closed system, without requiring external or physical manipulation to adjust the cervical control system. For example, the controller 1250 may include a Bluetooth® wireless communication device or other remote control device. A charging cable may be provided to charge the power source to charge the battery 1252, either inside or outside the patient. Optionally, a pressure transducer 1254 may be coupled to a controller 1250 to measure the pressure applied to the system 1200 and provide these measurements directly or indirectly to a display device, such as a computer screen. The information provided by the pressure transducer 1254 may be used, for example, to determine the status of the system 1200, the inflation / deflation state of the internal cuff 1208, and / or the pressure applied to the cervix 101 or vagina 103. In some embodiments, the pressure transducer 1254 may be adapted to detect a pressure drop within an acceptable range (such as one set by a healthcare provider), and the pump 1244 may be configured to automatically add fluid to an underinflated internal cuff 1208 to maintain a desired inflation level. In optional embodiments, a position and / or orientation sensing device (e.g., a solid-state gyro module) may be provided to detect orientation data of the cervical control system 1200 (e.g., the solid-state gyro module may detect and / or determine the angle of orientation of the system 1800 relative to the gravity vector).Based on positional data, the device may be adapted to automatically adjust the angle of the cervical control system if the cervical control system shifts beyond a desired position (such as one set by a healthcare provider). Any device, system, and / or method described herein may include one or more features disclosed in U.S. Patent Application No. 17 / 813,454 filed July 19, 2022, International Patent Application No. PCT / IB2022 / 056650 filed July 19, 2022, U.S. Provisional Application No. 63 / 237,708 filed August 27, 2021, or U.S. Provisional Application No. 63 / 300,263 filed January 18, 2022, each of which is incorporated in whole by reference.

[0128] Figures 58 and 59 show embodiments of System 1301, which includes a cervical control system 1300 (also referred to herein as "System 1300") and an inflation system 1302, where Figure 58 is a perspective view of System 1301 and Figure 59 is an exploded perspective view of System 1301. System 1300 shares some features and functions with Systems 100, 500, 1000, and 1100 described above and shown in Figures 1-6, 19-20, 36-37, and 51-54, such as an expandable annular inner cuff 1308 with a main body 1302, a proximal opening 1304, a distal opening 1306, an internal passage 1370, and a recess 1310 and an expandable portion 1312. Further similarity to the components of system 1100, system 1300 includes a positioning balloon 1318 positioned on the outer surface of the body 1302 near the distal opening 1306. Further similarity to the components of system 1100, system 1300 includes an array of cleats or teeth 1316 extending from the outer surface of the expandable portion 1312 into the internal passage 1370. In some embodiments, system 1300 may not include the cleats 1316.

[0129] The positioning balloon 1318 is inflated when the system 1300 is placed in the patient and is configured to expand away from the axis of the distal opening and into the vaginal wall. Similar to the system 1100, the positioning balloon 1318 of the cervical control system 1300 extends further up the wall of the body 1302 of the system 1300 than the positioning balloon 518 of the system 500, but in contrast to the system 1100, the positioning balloon 1318 of the cervical control system 1300 does not extend around the entire circumference of the body 1302. Instead, the positioning balloon 1318 extends only around a portion of the circumference of the body 1302 (e.g., 20–90%), as shown in Figure 58. When deflated, the positioning balloon 1318 may be flush with the outer surface of the body 1302 (e.g., the internal passage 1370) or extend about 0.1–3 mm away from it. When inflated, the positioning balloon 1318 (e.g., internal passage 1370) may extend approximately 0.5–12 mm, 6.25 mm, 4–7 mm, 7 mm, 4–6 mm, and values ​​in between these from the outer surface of the body 1302.

[0130] Placing the positioning balloon 1318 only around a portion of the circumference of the main body 1302 allows for more precise placement of the cervical control system within the patient's anatomical structure, resulting in, for example, no pressure and / or force being applied in the posterior direction, which can improve patient comfort and / or reduce the possibility that the inflated positioning balloon 1318 may press against the rectum, which could cause discomfort, constipation, and / or excretory complications. For example, the arcuate structure of the positioning balloon 1318 means that the distal positioning balloon 1318 of the system 1300 does not inflate uniformly (as in the case of an annular positioning balloon extending around the entire circumference of the main body of the cervical control system), and therefore pressure may not be applied uniformly to the vagina in all directions, resulting in no pressure being applied to organs and tissues close to the vagina (e.g., bladder, rectum, etc.), which could be damaged or irritated by the pressure applied to the vagina, which can make it more comfortable for the patient to wear the system 1300, especially over long periods (e.g., several days or several weeks). In some cases, inflation of the positioning balloon 1318 can adjust the position and / or orientation of the cervix to a posterior or anterior position. For example, inflation and / or expansion of the positioning balloon 1318 can cause movement of the system 1300 (e.g., forward movement), and since the system 1300 is positioned high on the cervix and the positioning balloon 1318 is positioned close to and / or in contact with the patient's fornix, this movement can tilt the cervix posteriorly. In some cases, the cervical control system does not have a positioning balloon and uses only an internal cuff. In some embodiments, the cervical control system does not include an internal cuff and uses only a positioning balloon. In these embodiments, the system 1300 may not apply compressive force to the cervix, but it can tilt the cervix to a preferred angle.

[0131] The 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). The system 1300 includes a first inlet (not shown) that is in fluid communication with an inner cuff 1308 and a second inlet (not shown) that is in fluid communication with a positioning balloon 1318, and the first end of the tube 1348 may be physically coupled to the system 1300 via the first inlet and / or the second inlet. Additionally or alternatively, the first inflation medium conduit 1344 may extend away from the second inflation medium conduit 1346 for insertion into the first inlet, as shown in Figure 59, and as a result, the first inflation medium conduit 1344 may be in fluid communication with the inner cuff 1308, as shown in Figure 58. Additionally, or alternatively, a second expansion medium conduit 1346 may be configured for insertion into a second inlet, thereby enabling fluid communication with the positioning balloon 1318 as shown in Figure 58. In some cases, the system 1301 may include more than two or fewer expansion medium conduits. For example, the system 1301 may include one, three, four, or more expansion medium conduits.

[0132] Tube 1348 is long enough (e.g., 7.62–60.96 cm (3–24 inches)) to extend away from system 1300 (if placed inside the patient's vagina) and out of the vaginal opening so that a healthcare provider can easily access the valve system 1350 without removing or repositioning system 1300 within the patient. The second distal end of tube 1348 and / or the second ends of the first inflation medium conduit 1344 and / or the second inflation medium conduit 1346 may be coupled to the valve system 1350, which includes the valve housing 1360 (see Figures 60–61C and the relevant discussion below for further details). The valve housing 1360 has a proximal end 1362 and a distal end 1364, which may be connected to the distal ends of the first conduit 1344 and the second conduit 1346 within tube 1348. The distal end 1364 of the valve housing 1360 can hold the first valve 1352 and the second valve 1354 and may include a first opening 1366a and a second opening 1366b (shown in Figure 59), so that the distal ends of the first valve 1352 and the second valve 1354, respectively, may be accessible and / or connectable to a syringe, pump, or other inflation device that can supply inflation medium for inflating the inner balloon 1308 and / or the positioning balloon 1318. The valve housing 1360 may include a cap 1368 that can be connected to the valve housing 1360 by a tether 1370 or other connector (e.g., a hinge). The cap 1368 can be removably coupled to the distal end of the valve housing 1360 and may be configured and / or disposed to cover the first valve 1352 and / or the second valve 1354 when closed (e.g., engaged with the distal end 1364) and to allow access to the first valve 1352 and the second valve 1354 when open (e.g., released from the distal end 1364). In some embodiments, the valve housing 1350 may not include the cap 1368.

[0133] 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 fluidize a first expansion medium conduit 1344, and a second valve 1352 configured to fluidize a second expansion medium conduit 1346. In some cases, the first valve 1352 and the second valve 1354 may be one-way valves, duckbill valves, silicone valves, check valves, Halkey-Roberts valves, Luer-operated check valves, check valves with polycarbonate bodies, and / or combinations thereof. The use of polycarbonate bodies for the first valve 1352 and / or the second valve 1354 may reduce and / or eliminate the risk that the valve may be unintentionally operated, damaging the seal and causing a loss of pressure.

[0134] In some embodiments, the valve housing 1350 may accommodate fewer or more (e.g., 3 to 6) valves. Alternatively, in some embodiments, the system 1301 may not utilize valves or valve housing 1350, and in these embodiments, the expansion medium source may be directly coupled to the first expansion medium conduit 1344 and / or the second expansion medium conduit 1346 and / or the tube 1348.

[0135] Figure 60 is a detailed exploded view of the valve system 1350 shown in Figure 59. As can be seen in Figure 60, the first valve 1352 can be aligned with the first opening 1366a (and eventually inserted into the first opening 1366a as shown in Figure 58), and the second valve 1354 can be aligned with the second opening 1366b (and eventually inserted into the second opening 1366b as shown in Figure 58). The first valve 1352 and / or the second valve 1354 can be fixed within the valve housing 1360 using any suitable means, including but not limited to chemical bonding, thermal bonding, mechanical bonding (e.g., press-fit and / or friction fit), and / or vibration bonding. The distal tips or ends of the first valve 1352 and / or the second valve 1354 may be configured to allow communication of the expansion medium source 1380 to the first valve 1352 and / or the second valve 1354 for coupling (e.g., Luer coupling, friction fit, etc.) and / or insertion with an expansion medium source 1380 such as a syringe, pump, or squeeze valve, and for communication with the first expansion medium conduit and / or the second expansion medium conduit and / or the inner cuff 1308 and / or the positioning balloon 1318, respectively. Exemplary expansion mediums include, but are not limited to, saline solution, air, gas, hydrogel, water, Newtonian fluids and / or non-Newtonian fluids.

[0136] 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 as shown in Figure 60, for example, and then permanently and / or removably joined. The valve housing 1360 may be formed from a flexible material such as silicone or vinyl.

[0137] During use, the system 1300 may be positioned inside the patient's vagina (e.g., vagina 103), so that a portion of the tube 1348 and the valve housing 1360 remain outside the vaginal opening, while the patient's cervix (e.g., cervix 101) may be located within the internal passage 1370, accessible by the clinician, who inserts or otherwise engages the first valve and / or second valve together with the inflation medium source 1380, and communicates the inflation medium to / from the respective first inflation medium conduits and / or second inflation medium conduits, which communicate to / from the inner cuff 1308 and / or positioning balloon 1318, so that the inner cuff 1308 and / or positioning balloon 1318 can be inflated and / or deflated as needed.

[0138] Since the main body 1302 is placed inside the vagina during use, it can be difficult to assess (e.g., visually or otherwise) how much pressure is being applied to the patient's tissue by the inner cuff 1308 and / or positioning balloon 1318. To assist in this assessment, the valve housing 1360 may include and / or be physically and / or communicatively coupled one or more sensors 1390 configured to 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 applied by the inflating medium present in the first conduit 1344 and / or the second conduit 1346, the flow rate of the inflating medium entering and leaving the first conduit 1344 and / or the second conduit 1346, the volume of the inflating medium entering and leaving the first conduit 1344 and / or the second conduit 1346, and / or changes thereof. In some embodiments, the sensor 1390 may be a tactile or visual pressure gauge with a display provided on the valve housing 1360, and / or may include such a pressure gauge.

[0139] In some embodiments, the sensor 1390 includes a first pressure gauge 1392 arranged in series between a first valve 1352 and a first expansion medium conduit 1344, and a second pressure gauge 1394 arranged in series between a second valve 1354 and a second expansion medium conduit 1346, to measure the expansion medium pressure in the respective first and second expansion medium conduits 1344 and 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 be inflated in stages to indicate how much pressure has increased within the components of the system 1300, and in some cases may be configured to indicate in separate increments how much pressure has increased and / or decreased within each of those conduits. For example, Figure 61E provides a cross-sectional view of an exemplary pressure gauge 1392 having a base 1396 whose upper surface (in the orientation shown in Figure 61E) has varying or stepped heights, where the central portion 1396a has a first height, the first ring 1396b around the central portion 1396a has a second height, and the second ring 1396c surrounding the first ring 1396b and defining the outer circumference of the pressure gauge 1392 has a third height, where, as shown, the first central portion 1396 is higher than the first ring 1396b, and the first ring 1396a 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 include a flexible material (e.g., silicon, latex, etc.) that expands when pressure is applied and contracts when the pressure is removed. In other words, the central portion 1396a may protrude from the valve housing 1350 in response to a first expansion pressure, the central portion 1396a and the first ring 1396b may protrude from the housing 1350 in response to a second expansion pressure higher than the first expansion pressure, and the central portion 1396a, the first ring 1396b, and the second ring 1396c may protrude from the housing in response to a third expansion pressure higher than the second expansion pressure.Therefore, the thinnest protrusion of the first thickness in the central portion 1396a can represent the lowest first expansion pressure, the second protrusion of the first ring 1396b can represent a second expansion pressure higher than the first expansion pressure, and the third protrusion of the second ring 1396c can represent a third expansion pressure higher than the second expansion pressure.

[0140] Additionally or alternatively, in some embodiments, the first pressure gauge 1392 and / or the second pressure gauge 1394 may include a visual color indicator. For example, the central portion 1396a, the first ring 1396b, and / or the second ring 1396c may be color-coded, for example, the central portion 1396a being a first color, the first ring 1396b being a second color, and the second ring 1396c being a third color. Any color that allows the user to visually distinguish different parts or areas can be used for any of those parts or areas. This visual color indicator or other visual indicator can help a clinician or user determine the pressure in the pressure sensor without requiring tactile acuity that may be impaired, for example, by wearing surgical or laboratory gloves. In some cases, the visual indicator can be a color, pattern, symbol, number, or other mark.

[0141] Figure 62A is a perspective view of system 1301 when the expansion medium source 1380 (embodied as a syringe) is located in a second valve 1354 and is in fluid communication with a second expansion medium conduit 1346 and a positioning balloon 1318, and the positioning balloon is in a deflated or neutral state, and Figure 62B is a cross-sectional view of system 1301 in that case. The positioning balloon 1318 of system 1300 is in a neutral or deflated state, and as a result, the second pressure gauge 1394 indicates that it is in a neutral state and that there is a neutral (e.g., atmospheric pressure) amount of pressure in the positioning balloon 1318 and the second expansion medium conduit 1346.

[0142] The syringe in Figures 62A and 62B includes a barrel 1382 filled with a certain amount of expansion medium 1384, a needle 1386 that is in fluid communication with the barrel 1382, and a plunger 1388 that is fitted into the barrel 1382 by a liquid-tight seal. As arranged in Figures 62A and 62B, the plunger 1388 extends outward from the barrel 1382, so that the volume of the expansion medium 1384 can be present in the barrel 1382, for example, when the expansion medium is introduced into a second valve 1354 and a second expansion medium conduit 1346 and communicates with a positioning balloon 1318 (therefore inflating the positioning balloon 1318), or when the expansion medium is extracted from the positioning balloon 1318 by the application of negative pressure caused by withdrawing the plunger 1388 from the barrel 1382 (therefore inflating the positioning balloon 1318).

[0143] Figure 63A is a perspective view of system 1301 when the expansion medium source 1380 (embodied as a syringe) is located inside the second valve 1354 and is in fluid communication with the second expansion medium conduit 1346 and the positioning balloon 1318. Figure 63B is a cross-sectional view of system 1301 in the same case, where the positioning balloon 1318 is in an expanded or expanded state after a portion of the volume of the expansion medium 1384 is transferred from the barrel 1382 to the second valve 1354, the second expansion medium conduit 1346, and the positioning balloon 1318, thereby inflating the positioning balloon 1318 as shown. When the plunger 1368 is pushed down within the barrel 1382 (i.e., pushed toward the needle 1386), a volume of the expansion medium 1384 is transferred from the barrel 1382 to the second valve 1354, the second expansion medium conduit 1346, and the positioning balloon 1318. This can pressurize the volume of the expansion medium 1384, thereby moving the expansion medium 1384 through the needle 1386 to the second valve 1354, the second expansion medium conduit 1346, and the positioning balloon 1318, thereby inflating the positioning balloon 1318 as shown. The plunger 1388 may be pushed down, for example, by 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 may indicate the pressure level in the second conduit 1346 (and therefore the positioning balloon 1318) by expanding as shown, in the same manner as discussed above with respect to Figures 61A to 61D. Figure 63B also shows the internal chamber 1350 of the inner cuff 1308. When expansion medium is added to the internal chamber 1350, the inner cuff 1308 (or the flexible membrane including the inner cuff or a portion thereof) may expand to accommodate the increase in the volume of expansion medium present in the internal chamber 1350, thereby inflating or expanding the inner cuff 1308.

[0144] If expansion and / or contraction of the inner cuff 1308 is desired, the expansion medium source 1380 can be drawn from the second valve 1354 and inserted into the first valve 1352, so that the volume of the expansion medium 1384 is injected into the first valve 1352, communicating with the first conduit 1344 and the inner cuff 1308, thereby expanding the inner cuff 1308. By reversing this process, the inner cuff 1308 can be contracted. Additionally, or alternatively, the inner cuff 1308 can be inflated by inserting a second expansion medium source 1380 (not shown), embodied, for example, as a syringe or pump, into the first valve 1352, thereby injecting the volume of the expansion medium 1384 into the first valve 1352, communicating with the first conduit 1344 and the inner cuff 1308, and thereby inflating the inner cuff 1308. By reversing this process, the inner cuff 1308 can be deflated.

[0145] In some embodiments, variations in the wall length and wall thickness of one or more of the positioning balloons disclosed herein may help control the direction in which the positioning balloon expands when pressurized (i.e., when inflated and / or filled with an inflation medium), for example, due to the properties of the material (e.g., silicone) used to fabricate the positioning balloon and / or the associated cervical control system. For example, Figure 64A provides a partial cross-sectional view of a cervical control system 1400 (also referred to herein as “System 1400”), such as a cervical control system 1300, which has a positioning balloon 1418 having varying wall thicknesses when in a neutral or deflated state, and Figure 64B is a partial cross-sectional view of System 1400 with a positioning balloon 1418 in an expanded or inflated state.

[0146] The positioning balloon 1418 may be similar to the positioning balloon 1318 (e.g., size, location extending from the outer surface of the system 1400, method of inflation via the inflation medium conduit, function, etc.). The 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, the proximal wall 1422, the distal wall 1424, and the outer surface of the main body 1402 form a positioning balloon chamber 1450 (see, for example, Figure 64B) which can be filled with an inflation medium to inflate or expand the positioning balloon 1418. The initial length L1 of the proximal wall 1422 and the initial length L2 of the distal wall 1424 may be equal, substantially equal, and / or different in order to adjust the expansion direction of the positioning balloon 1418. In the examples in Figures 64A and 64B, the length L1 of the proximal wall 1422 is approximately the same as the length L2 of the distal wall 1424, which may allow the positioning balloon 1418 to extend outward away from the outer surface of the main body 1402, and mainly in a direction perpendicular to the system body 1402 and / or parallel to the cross-section of the distal opening of the system 1400. Continuing with the examples in Figures 64A and 64B, the thickness (T1) of the proximal wall 1422 and the thickness (T2) of the distal wall 1424 are thinner (i.e., smaller in size) than the thickness (T3) of the vertical wall 1426.

[0147] For example, due to the properties of the material constituting the positioning balloon 1418, the unique thickness T3 of the vertical wall 1426, compared to the thicknesses T1 and T2 of the proximal wall 1422 and distal wall 1424, respectively, can help cause the positioning balloon 1418 to expand outward (to the left in the orientation of Figure 64B) while limiting the distal and proximal expansion as shown in Figure 64B. Thus, the configuration shown in Figure 64A allows the positioning balloon 1418 to expand outward from the outer surface of the main body 1402, and in a direction substantially perpendicular to the system body 1402 away from the axis of the distal opening, and / or in a direction substantially parallel to the distal cross-section of the cervical control system as indicated by the arrow in Figure 64B, and as a result, the positioning balloon chamber 1450 has a wider rectangular shape when expanded (Figure 64B) than when in the neutral state (Figure 64A). Although the cross-sections of the positioning balloons shown in Figures 64A and 64B are shown as rectangular or substantially rectangular, the cross-sections of the positioning balloons can be circular or substantially circular, semicircular or substantially semicircular, triangular or substantially triangular, inverted or substantially inverted triangular, square or substantially square, elliptical or substantially elliptical, partially elliptical or substantially partially elliptical, irregular shapes with asymmetrical cross-sections, or any other shape that can provide support to and / or engage with the vaginal wall. In some cases, the cross-sectional shape of the positioning balloon 1418 may be an inverted or substantially inverted triangular shape in which the vertices of the triangle can act as hinges to expand or contract.

[0148] The exemplary thicknesses T1 and T2 of the proximal wall 1422 and / or distal wall 1424 may be in the range of 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 within these ranges. The thickness T3 of the vertical wall 1426 may be 0.88 mm, and / or in the range of 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 within these ranges. In some cases, as described herein, the selected wall thickness may also depend on and / or the hardness level and / or durometer of the material being used. For example, when silicone is used, the selected wall thickness may also depend on and / or the hardness level and / or durometer of the silicone. For example, when a lower durometer silicone (e.g., 10A) is used, the wall thicknesses of T1 and / or T2 may be relatively thicker (e.g., 1-2 mm) than when a higher durometer silicone (e.g., 40A-80A on the Shore A scale) and / or a relatively thinner (e.g., 0.95-0.05 mm) or a material with higher elasticity / tear resistance (e.g., silicone dispersion material) is used. For example, the wall thicknesses of T1 and / or T2 may be 0.3 mm, 0.4 mm, 0.5 mm, 0.6 mm, 0.7 mm, 0.8 mm, and overlapping ranges within these ranges, and the silicone durometer selection may be 20A, 30A, 40A, or 50A. In some embodiments, the silicone durometer selection range can be 10A-70A. In some cases, assuming the wall is stretchable and the 10cc syringe used for handle operation can output approximately 20 psi, the wall thickness of the expandable wall can be 0.1 mm or more. In some cases, for a choice of hardness levels of 10A to 30A for the silicone durometer, the wall thicknesses T1 and T2 can be in the range of approximately 0.1 to 2 mm.In some embodiments (e.g., hardness 40A to 50A), wall thicknesses T1 and T2 can be in the range of 0.1 mm to 1 mm, and in other embodiments (e.g., hardness 60A to 70A), wall thicknesses T1 and T2 can be in the range of about 0.1 to 0.5 mm. Although the wall thicknesses and hardnesses described herein are described with reference to T1 and T2, examples of wall thicknesses and associated hardness levels can be used for any wall thickness of the dilation wall and / or membrane of the cervical control system.

[0149] In some embodiments, the internal cuffs disclosed herein may be designed and / or configured for directional expansion, for example, by taking advantage of their material properties and / or dimensions, as described herein and shown in Figures 9–12, 34, and 64A, 64B, particularly with respect to Figures 9–12 and 34. Another example of an internal cuff having various wall thicknesses that allows directional expansion in a preferred direction is shown in Figures 65A and 65B and 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 internal cuff 1508 in a neutral position, a positioning balloon 1518 in a neutral position, and a cervix 101 positioned within an internal passage 1570 of System 1500. System 1500 is similar to and / or may have similar features and / or functions to one or more of the cervical control systems disclosed herein. Figures 65A and 65B include a first virtual line 1501 and a second virtual line 1502, and the space between the first virtual line 1501 and the second virtual line 1502 defines the proximal plane 1503 of the neutral inner cuff 1508, as shown in Figure 65A.

[0150] Once the cervix 101 is positioned within the internal passage 1570 as shown in Figure 65A, the inner cuff 1508 can be inflated via the expansion medium pushed into the first expansion medium conduit 1544, for example, in the same manner as described above with respect to Figures 58–63, and especially Figures 62A–63B. During inflation, the inner cuff 1508 expands directionally toward the internal passage and downward (in the orientation of the cross-sectional view in Figure 65B) beyond the second imaginary line 1502, as a result the cleat 1516 pushes the outer surface of the cervix 101 and cervical tissue, pushing the cervical tissue further downward into the internal passage, thereby elongating the cervix 101 as shown in Figure 65B.

[0151] Directional expansion of the inner cuff 1508 can be achieved, for example, by changing the wall thickness of the material constituting the inner cuff 1508, as disclosed herein with respect to Figures 9–12, 34, and 64A, 64B. As can be seen in Figures 65A and 65B, the proximal cuff 1508 comprises a chamber 1520 communicating with a first expansion medium conduit 1544. In the neutral position, the chamber 1520 is bounded or defined by an inner wall 1521 having an elongated semicircular shape. The outer surface of the inner cuff 1508 is defined by an outer wall 1523 from which a cleat 1526 is formed. In the neutral state (e.g., Figure 65A), the space between the inner wall 1521 and the outer wall 1523 is relatively narrow in the proximal and distal wall portions and wider at the apex of the curve of the inner cuff 1508. As a result, the material constituting the inner cuff 1508 is thicker at the apex (i.e., towards the apex of the nearly semicircular curve of the inner cuff 1508) than in the proximal and distal wall portions. As the inner cuff 1508 is pressurized by the introduction of the expansion medium into the chamber 1520, the apex stretches or thins (e.g., by 10-95%), thereby expanding the chamber 1520 to accommodate the pressurization caused by the introduction of the expansion medium into the chamber 1520, in a preferred direction as shown in Figure 65B. The expansion of the inner cuff 1508 (e.g., radially inward and / or radially downward) acts to push the clit 1516 into the cervical tissue, thereby strengthening the engagement between the clit 1516 and the cervical tissue. Additionally or alternatively, the expansion of the inner cuff 1508 (e.g., radially inward and / or radially downward) may also act to push and close the cervix, and / or pull the cervix downward (relative to the first virtual line 1510 and the second virtual line 1502) so as to engage with the cervix 101, thereby compressing and / or extending the cervix 101 from its original state (e.g., see Figure 65A) to the compressed and / or extended state shown in Figure 65B, which may be useful, for example, in preventing premature birth and / or treating PPROM.

[0152] In other words, the tension, stretching, and / or compression of the cervix 101 by the inflation of the inner cuff 1508 can create an anatomical condition of the cervix 101 that can control cervical function (e.g., prevent dilation and / or shortening), and in some cases can provide conditions that lead to the replacement, dilation, and / or regeneration of a cervical mucus plug (not shown) located at or near the internal opening of the cervix 101.

[0153] For example, one portion of the inner cuff 1508 can expand more planarly or in a more planar direction toward the axis of the proximal opening of the cervical control system, while another portion of the inner cuff can expand slightly distally. This allows the cervical control system to intentionally twist the cervix. In some cases, the inner cuff can be sized to provide mechanical compression to the cervix in a neutral or non-expanded state by making the outer diameter of the inner cuff less than or equal to the diameter of the cervix. In some cases, the inner cuff can expand radially inward but not distally. In some cases, the inner cuff can expand distally but not radially inward. In other cases, the inner cuff can expand proximal only, or radially inward and proximal.

[0154] Figure 66 shows a partial side section view of an exemplary cervical control system 1600 (also referred to herein as "System 1600"). System 1600 is similar to, and / or may have common features with, systems 100, 500, 1000, 1100, 1300, 1400, and 1500 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, as a main body 1602, an inner cuff 1608 and a cleat 1616 positioned on the inner circumference of the inner cuff 1608 and extending therefrom, in a similar manner to how, for example, a cleat 1316 is positioned around the inner and / or outer surface of the inner cuff 1308 of system 1300, from which the cleat 1316 extends. The inner cuff 1608 is configured and designed to vary the wall thickness and length in portions that can facilitate expansion in a preferred direction (e.g., radially and / or distally). For example, the inner cuff 1608 may have a proximal wall 1632 with a first thickness T1 and a first length L1, a distal wall 1634 with a second thickness T2 and a second length L2, and a vertex section 1636 connecting the proximal wall 1632 and the distal wall 1634 to form the inner cuff 1600, which forms the inner chamber 1650 as shown. The vertex section 1636 may have a third thickness T3 at the vertex or center point of the cleat 1616, as shown in Figure 66. The remaining portion of the apex section 1636 (i.e., excluding the cleat 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 are thinner than the thicknesses T3 and T4 of the apex section 1636, which may allow the inner cuff 1608 to expand radially inward when it is pressurized (i.e., when an expansion medium is added to the inner chamber 1650). The exemplary first thickness T1 and / or second thickness T2 of the proximal wall 1632 and / or the distal wall 1634 may be in the range of about 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 within these ranges.The exemplary third thickness T3 of the apex portion 1636 with the cleat 1616 is approximately 1.65 mm, and / or may be in the range of 1 mm to 2 mm, 1.2 mm to 1.8 mm, 1.4 mm to 1.7 mm, 1.5 mm to 1.7 mm, 1.6 mm to 1.65 mm, and overlapping ranges within these ranges. The exemplary fourth thickness T4 of the apex portion 1636 other than the cleat 1616 is approximately 0.88 mm, and / or may be in the range of 0.4 mm to 2 mm, 0.6 mm to 1.8 mm, 0.8 mm to 1.6 mm, 1 mm to 1.4 mm, 0.8 mm to 1 mm, and overlapping ranges within these ranges. The third thickness at the thickest point of the cleat 1616 may be approximately 1.9 mm, and / or in the range of 1-3 mm, 1.5 mm-2.5 mm, 1.8 mm-2.2 mm, or 1.9 mm, and any overlapping ranges within these ranges.

[0155] As shown in Figure 66, the inner cuff 1608 has an inner wall 1638 extending from the proximal wall 1632 to the distal wall 1634, which can define the edge of the chamber 1350 approximately opposite the apex portion 1636. The inner wall 1638 can be parallel to the axis of the cervical control system. In other cases, the inner wall 1638 can be inclined upward or downward with respect to the axis of the cervical control system, or inclined (e.g., 90 to 170 degrees) with respect to the upper side (in the orientation of Figure 66) of the distal wall 1634, as shown in Figure 66. The angle of the inner wall 1638 shown in Figure 66 can help expand the chamber 1350 and / or the inner cuff 1608 in a preferred direction (e.g., downward), which can help, for example, elongate the cervix near the inner cuff 1608 and / or guide the cervix to a desired position within the system 1600. The inner cuff 1608 may be designed to have a downward bias in the neutral or contracted state, and as a result, even if the inner wall 1638 is inclined upward, the inner cuff 1608 may expand downward when inflated as described herein. As shown in Figure 66, the cross section of the inner cuff 1608 that engages with the outer surface of the main body may be an irregularly shaped cross section having an asymmetrical cross section. The cross-sections of the inner cuff 1408 and inner chamber 1450 shown in Figures 64A and 64B are shown as having an asymmetrical cross-section of roughly the shape of "D". However, the cross-sectional shape of the inner cuff 1408 and inner chamber 1450 may have any suitable shape, including, but not limited to, a rectangle, parallelogram, circle, substantially circle, semicircle, substantially semicircle, triangle, substantially triangle, square, substantially square, ellipse, substantially ellipse, partially ellipse, substantially partially ellipse, or any other shape that the inner chamber 1450 and / or inner cuff 1408 can, for example, control the cervix, provide support to the cervix, and / or assist in engaging with the cervix.

[0156] Additionally, or alternatively, the lengths L1 of the proximal wall 1632 and L2 of the distal wall 1634 can be modified to control the directional expansion of the medial cuff 1608. For example, the length L1 of the proximal wall 1632 can be longer than the length L2 of the distal wall 1634, which may facilitate the distal expansion of the medial cuff 1608 when it is pressurized.

[0157] Figures 67A–67C and 68A–68B show various diagrams of a cervical control system 1700 in a given position that may have similar features and / or functionality to systems 100, 500, 1000, 1100, 1300, 1400, 1500, and / or 1600 as described herein and shown in Figures 1–6, 19–20, 36–37, 51–54, 58–59, 64A–64B, 65A–65B, and 66, respectively. For example, system 1700 includes a main body 1702, a proximal opening 1704, a distal opening (not shown), an internal passage 1770, an expandable annular inner cuff 1708 having a recess 1710 and an expandable portion 1712, a positioning balloon 1718 located near the distal opening and on the outer surface of the main body 1702, and a plurality of cleats 1716 disposed on the outer surface and / or inner circumference of the inner cuff 1708, which are similar to, and / or may incorporate, the features of the main body, proximal opening, distal opening, internal passage, and expandable annular inner cuff with recess and expandable portion, positioning balloon, and / or cleats of systems 100, 500, 1000, 1100, 1300, 1400, 1500, and / or 1600 described herein and shown in the figures.

[0158] Figures 67A to 67C show a top view or distal (if in place) view of the cervical control system 1700 in a predetermined position, with the cervix 101 (represented as a circle in Figure 67A and as a dashed line in Figures 67B and 67C) positioned within the internal passage 1770. Two major blood vessels 1794 of the cervix 101 are also shown, positioned within the recess 1710 of the system 1700 in Figures 67A to 67C. Figures 67A to 67C also provide a first pair of virtual lines, including a first virtual line 1751 and a second virtual line 1752, positioned above and below (in the orientation shown in the figure) the system 1700 when the inner balloon 1708 and positioning balloon 1718 are deflated, and a second pair of virtual lines, including a third virtual line 1753 and a fourth virtual line 1754, positioned above and below (in the orientation shown in the figure) the inner cuff 1708 when the inner balloon 1708 and positioning balloon 1718 are deflated, so that a relative change in size between the inner cuff 1708 and the outer cuff 1718 in the neutral and inflated states can be observed.

[0159] In particular, Figure 67A shows a distal view of system 1700 when both the inner cuff 1708 and the positioning balloon 1718 are in a neutral or deflated state, as in the case where system 1700 is positioned in the patient's vagina 103 and the cervix 101 is positioned in the internal passage 1770. Figure 67B shows a distal view of system 1700 when 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 (note that the upper and lower sides of the inner cuff 1708 (in the orientation of Figure 67B) are extended beyond the third and fourth dashed lines 1703 and 1704, respectively). When the inner cuff 1708 is pressurized or inflated, the expandable portion 1712 may expand or extend radially inward, as shown in Figures 67B and 67C, and apply pressure around the cervix 101, excluding the blood vessels 1794, while the recess 1710 may remain in an uninflated or recessed state (i.e., not expand or extend radially inward, or expand or extend minimally), and as a result, the pressure caused by the expansion of the inner cuff 1708 is not applied to (or is applied to a reduced amount to) the cervical blood vessels 1794. This allows the expandable portion 1712 of the inner cuff 1708 to compress a large portion of the circumferential area of ​​the cervix 101 that is relatively uncompressed, close to the blood vessels 1794 (i.e., the portion close to the expandable portion 1712), while the recess 1710 of the inner cuff 1708 remains uncompressed or not very compressed, so that the cervical arteries are not compressed (or only slightly compressed), which allows blood flow through the blood vessels 1794 to be relatively unobstructed by the compression caused by the inner cuff 1708.

[0160] In some embodiments, the inner cuff 1708 may be provided with a material having a variable wall thickness (e.g., a flexible membrane) to form an expandable portion 1712 and a recess 1710 of the inner cuff 1708, the recess 1710 having a thicker wall thickness (and therefore greater resistance to expansion) than the expandable portion 1712. This arrangement can allow the expandable portion 1712 to expand or inflate at a lower pressure than the recess 1710. Additionally or alternatively, the recess 1710 may be a depression and / or recess in the wall and / or flexible membrane of the inner cuff 1701. Figures 67A to 67C show a recess 1710 having a substantially rounded rectangular shape, but the recess 1710 may be any suitable shape, including, for example, a semicircle, an ellipse, a trapezoid, a parallelogram, an irregular shape, and a combination thereof.

[0161] Figures 67A–67C show a recess 1710 of the inner cuff 1708 located on the opposite side of the inner cuff 1708 (for example, on the side approximately 180 degrees away). However, the recess 1710 can be located at any position along the inner cuff 1708 that is necessary and / or preferred to prevent the formation of blood vessels such as blood vessels 1704 and / or restriction of blood flow from arteries and / or veins to the cervix 101. In some cases, as shown in Figure 67A, the recess 1710 is present in the inner cuff 1708 prior to inflation or expansion of the inner cuff 1708, but this is not always the case. In some cases, when the inner cuff 1708 is pressurized, the internal volume of the recess 1710 may increase as the expandable portion 1712 expands or stretches radially inward.

[0162] Figure 67C shows a distal view of system 1700 with the inner cuff 1708 pressurized or inflated to apply pressure around the cervix 101 (as shown in Figure 67B and described above) and the positioning balloon 1718 in an inflated or expanded state (note that the lower edge of the positioning balloon 1718 (in the orientation of Figure 67C) is expanded beyond the second dashed line 1752).

[0163] Figure 68A is a top view of the system 1700 when it is not in a predetermined position (i.e., the cervix 101 is not positioned within the internal passage 1770), and Figure 68B provides a 90-degree cross-sectional view of the system 1700 in this case (along the dashed lines 1756 and 1757 shown in Figure 68A). As shown in Figure 68B, the internal cuff 1708 can be positioned around the circumference of the system 1700 at the proximal end of the system 1700, and the wall thickness of the recess 1710 may be thicker than the wall thickness of the expandable portion 1712, which may cause the internal chamber 1713 of the expandable portion 1712 to be larger than the internal chamber 1711 of the recess 1710, and / or contribute to the internal chamber 1713 of the expandable portion 1712 being larger than the internal chamber 1711 of the recess 1710. The larger internal chamber 1713 of the expandable portion 1712 has a larger volume than the internal chamber 1711 of the recessed portion and can accommodate more expansion medium, and this volume difference may contribute to the greater expandability of the expandable portion 1712 compared to the expandability of the recessed portion 1710.

[0164] In other cases, the inner cuff may be segmented instead of extending circumferentially around the cervical control system to provide expandable portions and recesses. In such cases, each segment may be supplied with a tube or conduit assembly for providing pressure to each individual segment. In some cases, the inner cuff does not include recesses and expandable portions. In some cases, the inner cuff does not have a variable wall thickness.

[0165] Figures 69A to 69H provide various diagrams of a system 1801 including a cervical control system configured to have a single valve and its components. In particular, Figure 69A is a top view of an exemplary single-valve system 1850 including a single-port valve housing 1860, a single valve 1854, a valve base 1852, and a valve cover 1868 including an extension 1867 defining a recessed area 1865; Figure 69B is a perspective view of the exemplary single-valve system 1850; and Figure 69C provides a cross-sectional view of the exemplary single-valve system 1850 (along the vertical bisector dashed line 69C in Figure 69A). The extension 1867 may be sized, positioned, and configured to fit into and protect a portion of the valve 1854 that extends from the valve base 1852 and resides within the recessed area 1865 when the valve cover 1868 is pressed over the valve 1854 and closed. The single-port valve housing 1860 may be configured to hold the valve 1854 in a manner similar to that of the valve housing 1360, for example. The valve 1854 may be, for example, a one-way valve, a duckbill valve, a silicone valve, a check valve, a Halkey-Roberts valve, a Luer-operated check valve, or a check valve with a polycarbonate body.

[0166] As can be seen in the cross-section of Figure 69C, the single-port valve housing 1860 may include a channel 1846 configured to cooperate with an expansion medium conduit that can fluidly communicate with one or more components of a cervical control system, such as the cervical control systems 1800A and / or 1800B shown in Figures 69D to 69H.

[0167] Figure 69D is a top view of an exemplary cervical control system 1800A or cervical control system 1800B having a single expansion medium conduit; Figure 69E is a cross-sectional view of the cervical control system 1800A (also referred to herein as system 1800A) along the virtual bisector 69E69F of Figure 69D; and Figure 69F is a cross-sectional view of the cervical control system 1800B (also referred to herein as system 1800B) along the virtual bisector 69E69F of Figure 69D. The cervical control systems 1800A and / or 1800B may include a system 1801, for example, as shown in Figures 69G to 69H. Like many of the cervical control systems disclosed herein, systems 1800A and 1800B include a main body 1802, an expandable annular internal cuff 1808 (also referred to herein as “internal cuff 1808”) having a proximal opening 1804, a distal opening 1806, an internal passage 1870, a recess 1810, an expandable portion 1812, and a flexible membrane defining an internal chamber 1855 (also referred to herein as “internal cuff internal chamber 1855”), a positioning balloon 1818 positioned on the outer surface of the body 1802 near the distal opening 1806, and a positioning balloon internal chamber The system includes a positioning balloon 1818 containing a flexible membrane defining the humb 1850, and a plurality of cleats 1816 disposed on the outer surface and / or inner circumference of the inner cuff 1808, which are similar to, and / or may incorporate, the features of the respective features of the main body, proximal opening, distal opening, internal passage, and expandable annular inner cuff, positioning balloon, and / or cleats of the systems 100, 500, 1000, 1100, 1300, 1400, 1500, 1600, and / or 1700 described herein and shown in the figures.

[0168] System 1800A further includes an expansion medium conduit 1844 extending from an inlet 1820 (which may be similar in form, function, and / or configuration to the inlet 120) to a cross channel 1846, both of which are in fluid communication with the positioning balloon internal chamber 1850 as shown. System 1800A also includes an inner cuff expansion medium conduit 1848 extending from the expansion medium conduit 1844 and in fluid communication with the expansion medium conduit 1844. During expansion, the expansion medium may be pushed into the expansion medium conduit 1844 via the inlet 1820. From there, the expansion medium is pushed at a relatively uniform rate into the inner cuff expansion medium conduit 1848 and collected in the internal chamber 1855, and into the cross channel 1846 and collected in the positioning balloon internal chamber 1850, so that, for example, the internal chamber 1855 and the positioning balloon internal chamber 1850 are filled with the expansion medium at approximately the same rate. In embodiments where the inner chamber 1855 and the positioning balloon inner chamber 1850 have the same or similar overall volume, the inner cuff 1808 and the positioning balloon 1818 may expand at approximately the same rate as the expansion medium is added to the expansion medium conduit 1844. In embodiments where the inner chamber 1855 has a smaller volume than the positioning balloon inner chamber 1850, the inner cuff 1808 may expand faster than the positioning balloon 1818. In embodiments where the inner chamber 1855 has a larger volume than the positioning balloon inner chamber 1850, the inner cuff 1808 may expand more slowly than the positioning balloon 1818.

[0169] Like system 1800A, system 1800B further includes an inflation medium conduit 1844 extending from the inlet 1820 to the cross channel 1846. However, a choke point 1846 is located within the cross channel 1846, configured and positioned to slow the flow rate of inflation medium into the positioning balloon inner chamber 1850, so that the inflation medium flows through the inflation medium conduit 1844 to the inner cuff inflation medium conduit 1848 faster than the choke point 1848 in the cross channel 1846, and the inner chamber 1855 fills faster than the positioning balloon inner chamber 1850, thereby inflating the inner cuff 1808 before the positioning balloon 1818. Thus, the choke point 1846 can allow the inner cuff 1808 to expand around the cervix (e.g., cervix 101) located within the inner passage, for example, as shown and described herein, before the positioning balloon 1818 is inflated. This may allow the clinician to fix the system 1800B to the patient's cervix (by expanding the inner cuff 1808) before performing cervical repositioning (e.g., adjusting the angle) or before otherwise attaching the system 1800B to the patient's vagina and / or before inflating the positioning balloon 1818 to hold the system 1800B in place.

[0170] Figure 69G is an exploded view of system 1801, and Figure 69H is an assembled view of system 1801. As can be seen in Figure 69G, the positioning balloon 1818 is positioned in line with the body 1802 of system 1800A or system 1800B and is fixed to the main body 1802 as shown in Figure 69H. System 1801 also includes a tube 1848 which may be positioned in line with the inlet 1820, thereby establishing fluid communication between the tube 1848 and the expansion medium conduit 1844 when assembled as shown in Figure 69H. As shown in Figure 69G, the tube 1848 may be aligned with the first side of the single-port valve housing 1860, and the valve 1854 may be aligned with the second side of the single-port valve housing 1860, and when assembled as shown in Figure 69H, system 1801 is formed.

[0171] System 1800 also includes an inner cuff expansion medium conduit 1848 extending from the expansion medium conduit 1844 and in fluid communication with the expansion medium conduit 1844. During expansion, the expansion medium can be pushed into the expansion medium conduit 1844 via the inlet 1820. From there, the expansion medium is pushed at a relatively uniform rate into the inner cuff expansion medium conduit 1848 and collected in the inner chamber 1855, and into the cross channel 1846 and collected in the positioning balloon inner chamber 1850, so that, for example, the inner chamber 1855 and the positioning balloon inner chamber 1850 are filled with the expansion medium at approximately the same rate. In embodiments where the inner chamber 1855 and the positioning balloon inner chamber 1850 have the same or similar overall volume, the inner cuff 1808 and the positioning balloon 1818 can expand at approximately the same rate as the expansion medium is added to the expansion medium conduit 1844. In embodiments where the internal chamber 1855 has a smaller volume than the positioning balloon internal chamber 1850, the internal cuff 1808 may expand faster than the positioning balloon 1818. In embodiments where the internal chamber 1855 has a larger volume than the positioning balloon internal chamber 1850, the internal cuff 1808 may expand more slowly than the positioning balloon 1818.

[0172] Figures 70A–70C show a cervical control system 2300 configured to support the patient's pelvic organs (e.g., uterus 105, bladder, etc.) and / or hold the uterus in place, thereby reducing and / or preventing, for example, uterine prolapse. Specifically, Figure 70A is a top or proximal view of the system 2300, and Figure 70B is a bottom or distal view of the system 2300. System 2300 is similar to systems 100, 500, 1000, 1100, 1300, 1400, 1500, 1600, 1700, and 2200 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, respectively, and may include a main body 2302, a proximal opening 2304, a distal opening 2306, an expandable inner cuff 2308 with an expandable portion 2312 and a recess 2310, an expandable positioning balloon 2318, and a cleat 2316. The inner cuff 2308 and / or positioning balloon 2318 can be inflated and / or deflated using an expansion medium conduit, valve, valve housing, and / or expansion medium source, such as an expansion medium conduit valve, valve housing, and / or expansion medium source disclosed herein, and two ports 2392 shown in Figure 70B can be utilized.

[0173] The positioning balloon 2318 is configured to extend around a portion of the exterior of the main body 2302 (e.g., 50-95%). For example, as shown in Figures 70A and 70B, the positioning balloon 2318 is similar to the positioning balloon 1318 in that it covers only a portion of the circumference of the outer surface of the main body 2302. However, in the embodiments of Figures 70A and 70B, the positioning balloon 2318 is an arc shape (or horseshoe shape) positioned around more than 180 degrees of the circumference of the main body 2302, extending beyond the outer circumference of the main body 2302. For example, compared to the positioning balloon 1308 and / or positioning balloon shown and / or described with reference to Figures 58-59, 62-65, and 67-68, the larger arc shape or super-arc shape of the positioning balloon 2318 can be particularly useful in controlling, mitigating, and / or preventing pelvic organ prolapse, as the larger arc shape of the positioning balloon 2318 acts to increase the overall diameter of the system 2300 when inflated, which can help to fix the system 2300 occupying space within the vagina (thus preventing pelvic organs from entering the vagina) and / or to distribute the forces within the vagina (e.g., vagina 103) so that the forces do not concentrate at one or more pressure points (as in the case of positioning balloon 1318). Additionally, the system 2300 may provide additional mechanical support to the ligaments and tissues that hold the pelvic organs, which, when inflated, are naturally used to hold the prolapsed organs in place.

[0174] In some cases, when used in PPROM, the supporting ligaments may be healthy, and in such cases, pregnancy will further restrict the total space within the vaginal canal. Therefore, it may be useful for the positioning balloon to have a small arc shape or a less arc shape, and the positioning balloon may be used for the purpose of shifting the cervical angle rather than fixing the cervical control system. In some cases, a larger arc shape (or horseshoe shape) fixes the cervical control system and provides mechanical support against uterine prolapse by allowing an increase in the diameter of the cervical control system, while still biasing the cervical control system in a particular direction, through only one inflatable portion of the inner cuff (as opposed to a cuff that extends around the entire circumference of the cervical control system).

[0175] In some cases, the system 2300 can be oriented within the vagina such that the area of ​​the outer surface of the main body 2302 is not covered or occupied, but the positioning balloon 2318 is positioned near and / or covering a portion of the patient's anatomical structure where the bladder or colon is located. Such orientation prevents the positioning balloon 2318 (when expanded) from pressing against the patient's bladder or colon, thereby applying pressure to and / or irritating these organs. As shown in Figure 70C, when the system 2300 is oriented in this manner, inflation of the positioning balloon 2318 occurs, thereby positioning the cervical control system so that it is fixed within the vaginal canal, but the portion of the main body 2302 not covered by the positioning balloon 2318 can contact the bladder and / or rectum. In this way, inflation of the positioning balloon 2318 and / or use of the system does not compress the bladder and / or rectum, interfere with their movement, and / or cause discomfort to the patient during use of the system 2300.

[0176] In other cases, the system 2300 can be rotated 180 degrees from the position shown in Figure 70C, so that the positioning balloon 2318 is positioned to be pushed up into the bladder space, for example, to prevent and / or reduce bladder prolapse. Additionally or alternatively, the system 2300 can be rotated in any direction to accommodate patient comfort. The ability to rotate or position the system 2300 in any configuration is beneficial to the patient, because pressure on the bladder can be beneficial to patients with bladder prolapse but irritating to patients with overactive bladder. Rotation during configuration, but before inflation, can allow pressure to be applied to the anterior wall of the vaginal canal. In some cases, the increase in diameter resulting from the inflation of the positioning balloon 2318 can help to secure the cervical control system to the vaginal canal.

[0177] Figure 71A provides a bottom perspective view of an exemplary cervical control system 1900 (also referred to herein as “System 1900”) positioned on the vaginal side of the cervix and configured, for example, to mitigate the effects of cervical shortening and / or prevent premature birth, and Figure 71B provides a cross-sectional view of the exemplary cervical control system 1900.

[0178] System 1900 shares some features and functionalities with the cervical control systems disclosed herein, such as Systems 100, 500, 1000, and 1100 shown above and in Figures 1-6, 19-20, 36-37, and 51-54, for example, a main body 1910 including an inner cuff 1905 that fluidly communicates with an inner cuff port 1920 and an inner cuff expansion medium conduit (not shown), and an internal channel 1935 that includes a plurality of ports 1940, including an internal channel-connecting port 1945 and an internal channel that communicates with an internal channel expansion medium conduit (not shown). Each port 1940 may be configured to allow a fluid (e.g., a drug, antimicrobial agent, etc.) to exit the internal channel and flow to the cervix located in the inner wall of System 1900 and / or in the internal passages of System 1900, for example, as shown and described herein. Multiple ports 1940 can be arranged at uniform intervals around the proximal interior of the system 1900, and internal channels 1935 can be arranged concentrically within the main body 1910, for example, as shown in Figure 71B. In other embodiments, the cervical control system 1900 may include multiple channels inside or outside the cervical control system 1900. The system 1900 also includes a pair of coupling channels 1915 configured to receive and bond to a positioning balloon cover and / or flexible membrane, for example, as shown in Figures 69G and 69H.

[0179] When the flexible membrane of the positioning balloon is attached via the coupling channel 1915 and the system 1900 is positioned near the cervix, the positioning balloon and inner cuff 1905 may be inflated with an inflation medium, for example, as described herein. Communication between the internal channel 1935, port 1940, and internal channel coupling 1945 may be used, for example, to communicate material (indicated by small arrows in Figure 71B) exiting one or more ports 1940 to the cervical tissue. Additionally, or alternatively, negative pressure and / or vacuum may be delivered to the internal channel 1935 and port 1940 via the internal channel coupling 1945. Negative pressure and / or vacuum may act to expel material (e.g., blood, vaginal secretions, bacteria, saline solution, etc.) from the cervix and / or to engage or hold the cervix in place.

[0180] Figure 72A provides a top view of a triple-port valve housing 2000, which can be used with system 1900 and includes a base 2010 and an articulated or collapsible cover 2040, and Figure 72B provides a bottom view of the triple-port valve housing 2000. As can be seen in Figure 72A, the first side or top 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 over the base 2010. The cover 2040 further includes a second recess 2021 sized, positioned, and configured to cover the second port 2020 when the cover 2040 is folded over the base 2010, and a third recess 2026 sized, positioned, and configured to cover the third port 2025 when the cover 2040 is folded over the base 2010. As can be seen in Figure 72A, the second side or bottom side of the base 2010 includes a first lumen coupling 2045 inserted into and / or cooperating with the first lumen 2065 of the tri-lumen tube 2060 and sized, shaped, and configured to communicate with the first port 2015, and a cross-sectional view of the tri-lumen tube 2060 is provided by Figure 73. The bottom of the base 2010 further includes a second lumen coupling 2050, which is inserted into and / or cooperates with the second lumen 2070 of the tri-lumen tube 2060 and is sized, shaped, and configured to communicate with the second port 2020, and a third lumen coupling 2055, which is inserted into and / or cooperates with the third lumen 2075 of the tri-lumen tube 2060 and is sized, shaped, and configured to communicate with the third port 2025.The cover 2040 folds over the first port 2015, the second port 2020, and the third port 2025 to protect the ports and / or prevent foreign objects from entering the ports, for example, when the triple port valve housing is positioned inside the vagina but is not coupled to another device.

[0181] Figure 74A provides an exploded view of the assembly 1901 of the cervical control system 1900, the triple port valve housing 2000, and the tri-lumen tube 2060, showing how the tri-lumen tube 2060 is positioned between the cervical control system 1900 and the triple port valve housing 2000, aligned with them, and coupled to them. Figure 74B provides an enlarged view of a tri-lumen tube 2060 aligned to the rear side of the triple-port valve housing 2000, the end of which has a first valve coupling extension 2070 inserted into and / or configured to work with the first lumen coupling 2045, a second valve coupling extension 2080 inserted into and / or configured to work with the second lumen coupling 2050, and a third valve coupling extension 2087 inserted into and / or configured to work with the third lumen coupling 2055. Figure 74C provides a bottom perspective enlargement of the assembly of the cervical control system 1900 and the tri-lumen tube 2060, wherein the fourth coupling extension 2090 of the tri-lumen tube 2060 is coupled to the internal cuff port 1920, the fifth coupling extension 2092 of the tri-lumen tube 2060 is coupled to the positioning balloon inflation port 1930, and the sixth coupling extension 2094 of the tri-lumen tube 2060 is coupled to the internal channel coupling port 1945.

[0182] In some embodiments, the cervical control system 1900, the triple-port valve housing 2000, and the tri-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 provides a side exploded view of an assembly 1901 of the cervical control system 1900, the triple-port valve housing 2000, and the tri-lumen tube 2060, as well as two check valves 2110 (only one is illustrated) (e.g., a Halkey-Roberts check valve) and / or one or more duckbill valves 2215, and Figure 75B provides a perspective exploded view thereof. As can be seen in Figure 75B, the first check valve 2110A is inserted into the first port 2015, the second check valve 2110B is inserted into the second port 2020, and the duckbill valve 2215 is inserted into the third port 2025. Figure 75B provides a rear perspective view of the fully assembled assembly 1901 with the first check valve 2110A inserted into the first port 2015, the second check valve 2110B inserted into the second port 2020, and the duckbill valve 2215 inserted into the third port 2025. The first check valve 2110A and the second check valve 2110B may be configured to allow the passage of liquid or gas to their respective lumens and expansion medium conduits and to maintain the pressure on their respective inner cuffs 1905 and positioning balloons after their expansion. The duckbill valve 2215 may be configured to accept the insertion of fluid and / or gas into the third lumen 2075 for communication with the internal channel 1935.

[0183] In some embodiments, as shown in Figure 76A, assembly 1901 can be further coupled with a micropump assembly 2120 and a reservoir 2155 configured to hold a certain amount of substance (e.g., drug, saline solution, alcohol, gas, etc.) to be pumped into a third lumen 2075 for circulation within an internal channel 1935, so that the substance can exit through one or more of a plurality of ports 1940. In these embodiments, as shown in Figure 76C, an extension 2160 of the reservoir 2155 can be inserted until it is fully installed in the corresponding opening 2150 of the body 2125 of the micropump assembly 2120, and Figure 76C provides a perspective view of the reservoir 2155 installed within the micropump assembly 2120 and the triple-port valve housing 2000 engaged with the micropump assembly 2120. Figures 76A and 76B show how the projection or nozzle 2140 of the micropump assembly can be 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 the second opening 2135, respectively, so 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 may be located within the base 2145 and may be configured to close the first check valve 2110A and the second check valve 501B, respectively, to prevent, for example, undesirable activation of the check valves and / or the entry of undesirable substances into the check valves. In some embodiments, the first check valve 2110A and / or the second check valve 2110B may be closed by mechanical engagement, for example, by friction fit with one of the first openings 2130 and / or the second opening 2135.

[0184] The micropump assembly 2120 may be configured to pump the liquid and / or gas contained in the reservoir 2155 from the reservoir 2155, through the nozzle 2140, into the duckbill valve 2215, and then pump it into the third lumen 2075, communicating with the channel 1935 and cervical tissue through one or more of the multiple ports 1940, for example, to administer a quantitative, periodic, as-needed, and / or continuous dose of the substance contained in the reservoir 2155 over a period of time. In some embodiments, the reservoir 2155 may hold a certain amount of vaginal progesterone that can be pumped from the reservoir 2155 into the channel 1935, providing a quantitative, periodic, as-needed, and / or continuous dose of vaginal progesterone while the cervical control system and pump remain in the patient's vaginal canal.

[0185] In some embodiments, the micropump assembly 2155 may be covered with a biocompatible and adaptable material (not shown), such as, but not limited to, silicone, which may help reduce discomfort if the micropump assembly 2120 and reservoir 2155 remain in place in the vaginal canal during use. After the system 1900 has completed the administration plan, the clinician may replenish or replace the reservoir 2155, or remove the entire micropump assembly 2120 and close the cap 2040 of the triple-port valve housing 2000.

[0186] In some embodiments, the channel 1935, the third port 1945, and / or the third lumen 2075 may comprise and / or be filled with and / or include a photoconductive material such as a fiber optic cable and / or silicone having a refractive index greater than 1.4. The photoconductive material may be configured and / or selected to allow ultraviolet transmission which can be used to eradicate or mitigate localized bacterial colonization.

[0187] Figure 77 provides a side view of an exemplary assembly 1902, which includes a syringe 1380 that holds a certain amount of fluid in its barrel 1382. The needle 1386 of the syringe 1380 is inserted into the duckbill valve 2215, and as a result, the amount of fluid held in the barrel 1382 is pushed into the third lumen 2075 for communication with the channel 1935 and port 1940 by pushing a plunger 1388 into the barrel 1382.

[0188] Figures 78A to 78J provide various diagrams of mold pieces and mold assemblies that may be used to fabricate, mold, and / or manufacture one or more of the cervical control systems described herein. In particular, Figure 78A is a bottom view of the upper mold 7801, Figure 78B is a bottom view of the mold waist 7802, Figure 78C is a top view of the mold waist 7802, Figure 78D is a cross-sectional view of the upper mold 7801 along the bisector 78D of Figure 78A, Figure 78E is a cross-sectional view of the mold waist 7802 along the bisector 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 along the bisector 78G of Figure 78F, Figure 78H is a cross-sectional view of the assembly 7805 of the upper mold 7801, mold waist 7802, and bottom mold 7803, and Figure 78I is a molded child Figure 78A-78M is an exploded perspective view of assembly 7805 with the cervical control system 7700, Figure 78J is a bisecting section of the exploded assembly 7805 of the cervical control system 7700, Figure 78K is a bisecting section of the cervical control system 7700, Figure 78L is an oblique section of the cervical control system 7700, and Figure 78M is a bisecting section of the cervical control system 7701, which is the cervical control system 7700 with the inner cuff fully assembled (i.e., the flanges of the flexible membrane constituting the inner cuff are inserted into and coupled into corresponding grooves present in the main body of the system). All directional reference terms used in the following discussion of Figures 78A-78M (e.g., top, bottom, upper side, lower side, etc.) are derived from the orientations shown in Figures 78H-78J. The term "distal" refers to the side of the system opposite the internal cuff and is generally configured for use near the fornix (towards the uterus), while the term "proximal" generally refers to the side of the system furthest from the uterus when the system is in place.

[0189] The mold upper section 7801, the mold waist 7802, and / or the mold bottom section 7803 are aligned with each other and / or compressed together to produce one or more of the cervical control systems disclosed herein using any suitable devices, tools, mechanisms, and / or systems, including but not limited to alignment pins, alignment holes, alignment grooves, alignment extensions, clamps, presses, alignment blocks, etc. Material (e.g., silicone) may be added to the mold upper section 7801, the mold waist 7802, and / or the mold bottom section 7803 by injection or other means (e.g., by pressing) and / or used with these molds to produce one or more of the cervical control systems disclosed herein.

[0190] As can be seen in the bottom and cross-sectional views of the mold upper 7801 provided by Figures 78A and 78D, respectively, the mold upper 7801 includes a proximal opening extension 7872 sized, configured, and positioned for molding or manufacturing a proximal opening of a cervical control system, such as the proximal opening disclosed herein. The upper mold 7801 further includes a pair of upper recess notches 7810A sized, configured, and positioned for molding or manufacturing the upper surface of a recess of a flexible membrane, such as the recess disclosed herein. The mold upper 7801 also includes a plurality of cleat notches 7816 sized, configured, and positioned for molding or manufacturing a plurality of corresponding cleats extending from the outer surface of the flexible membrane of an inner cuff, such as the cleats disclosed herein. The mold upper 7801 further includes an angled plane 7806 sized, configured, and positioned to form or manufacture the upper surface of the flexible membrane of an inner cuff, such as the flexible membrane and inner cuff disclosed herein. The mold upper 7801 further includes an extension notch 7804 sized, configured, and positioned to form or manufacture the upper surface of a groove extending from the outer periphery of the flexible membrane of the inner cuff.

[0191] As can be seen in Figures 78B, 78C, and 78E, the mold waist 7802 includes a mold waist base 7828, a central opening 7836 sized, configured, and positioned to allow the manufacture of an internal passage by insertion of an internal passage extension 7842 provided by the bottom mold 7803 (see, for example, Figures 78F and 78G), and a pair of lower recess notches 7810B sized, configured, and positioned to form or manufacture the lower surface of a recess of the flexible membrane, such as the recess disclosed herein. The mold waist 7801 further includes a flexible membrane surface 7834 sized and configured to be positioned near the angled plane 7806 of the upper mold 7801 (see, for example, Figure 78H), so that a negative space between the upper mold 7801 and the waist mold 7802 forms the inner cuff flexible membrane, the inner cuff internal chamber, and the flexible membrane extension. The mold waist 7801 further includes a lower extension groove 7822, sized, configured, and positioned to form the lower side of a flexible membrane extension, configured to work in cooperation with an extension notch 7804 to fit into a groove of a cervical control system formed by a groove extension 7844 (see, for example, Figure 78H). The mold waist 7802 further includes a positioning balloon groove 7878, sized, configured, and positioned to form a groove into which a flexible membrane of a positioning balloon can be fitted, as shown, for example, in Figures 59 and / or 69G. The mold waist 7902 further includes a fluid conduit feature 7832, configured to work in cooperation with a fluid conduit extension 7864 of the bottom mold 7803 to form a cavity for one or more fluid conduits, such as the fluid conduits disclosed herein. As can be seen in the cross-section of Figure 78E, the flexible film surface 7834 may enclose and include material used to create an inner chamber of the inner cuff, such as the inner chamber disclosed herein.

[0192] Figure 78F provides a top view of the bottom mold 7803, and Figure 78G provides a cross-sectional view of the bottom mold 7803. The bottom mold 7803 includes a bottom mold base 7852 having an inner passage extension 7842 having a cleat projection 7856 and a recess projection 7854 extending therefrom. The cleat projection 7856 may be sized, positioned, and configured to cooperate with a cleat notch 7816 of the upper mold 7801 to form a cleat extending from the outer surface of the flexible membrane of an inner cuff, such as the cleat, flexible membrane, and inner cuff disclosed herein. The recess projection 7854 may be sized, positioned, and configured to cooperate with an upper recess notch 7810A and a lower recess notch 7810B to form a recess of an inner cuff of a cervical control system, such as the recess of an inner cuff disclosed herein. The bottom mold base 7852 further includes a cervical control system distal edge groove 7846, sized, positioned, and configured to form the lower or distal edge of a cervical control system, such as the cervical control system disclosed herein. The bottom mold base 7852 also includes a curved groove 7848, sized, positioned, and configured to form the lower or distal edge of a flexible membrane forming an inner cuff, such as the inner cuff disclosed herein.

[0193] When molding or manufacturing a cervical control system such as the cervical control system disclosed herein, the bottom mold 7803 can be placed on a surface, and the mold waist 7802 can be aligned with the bottom mold 7803 before use. The mold upper 7801 can then be aligned with the mold waist 7802 and fitted onto it. The mold upper 7801, mold waist 7802, and mold base 7803 can be compressed together (e.g., clamped) or otherwise assembled so as to reduce and / or eliminate the possibility of movement between the mold pieces. A cross-sectional view of an exemplary assembly 7805 comprising the upper mold 7801, mold waist 7802, and bottom mold 7803 is provided by Figure 78H, where the negative space between the upper mold 7801, mold waist 7802, or bottom mold 7803 (i.e., the space not occupied by the upper mold 7801, mold waist 7802, or bottom mold 7803) can define the shape and configuration of a molded cervical control system, such as the cervical control system disclosed herein.

[0194] Next, a material for manufacturing the cervical control system (e.g., silicone, plastic, etc.) is injected into a mold assembly (e.g., mold assembly 7805) to form a cervical control system such as the cervical control system disclosed herein. Once the material has cured, the mold assembly can be disassembled, and as a result, the molded cervical control system can be removed therefrom. Figure 78I provides an exploded perspective view of assembly 7805 after the cervical control system 7700 has been molded, and Figure 78J provides a cross-sectional view of the assembly 7805. Using assembly 7805, the cervical control system can be molded substantially integrally, except for the attachment of a flexible membrane for forming a positioning balloon. This leads to improved durability and performance while simplifying the manufacturing process, reducing the number of joints of additional parts, and lowering manufacturing costs.

[0195] Figures 78K and 78L provide cross-sectional and cross-sectional views, respectively, of the cervical control system 7700 (also referred to herein as system 7700) after it has been removed from assembly 7805 and before the inner cuff 7708 has been assembled. System 7700 includes many of the components of the cervical control system disclosed herein, including a main body 7702, a distal opening 7706, an internal passage 7770, a flexible membrane 7713, and a plurality of cleats 7716. The flexible membrane 7713 further includes a recess 7715 formed by a positioning balloon groove 7878, which is located on the outer surface of the main body 7702 and configured to receive a flexible membrane (not shown) of a positioning balloon that can be attached, for example, as shown in Figure 59 and / or Figure 69G.

[0196] The system 7700 further includes an open area 7755 which is sized, shaped, and configured to provide an internal chamber 7756 to the system when the extension 7752 is positioned in the groove 7750 and / or joined in the groove 7750, thereby forming a fully assembled inner cuff 7708 of the cervical control system 7701 as shown in the cross section of Figure 78M. The inner cuff 7708 further includes a recess 7710 and an expandable portion 7712 which are configured and / or may function similarly to the recesses and expandable portions of the inner cuffs disclosed herein.

[0197] Figure 79 is a flowchart illustrating an exemplary process 7900 for determining whether a cervical control system, such as the cervical control system disclosed herein, should be inserted and / or used for a patient, and / or how the cervical control system should be inserted and / or used to, for example, promote the regeneration and / or repair of the cervical mucus plug, prevent premature labor and / or preterm birth, prolong fetal gestation, and / or treat cervical shortening, PROM, PPROM, pregnancy complications, and / or prolapse of pelvic organs and / or tissues. Process 7900 may be performed, for example, by a clinician, healthcare provider, physician, surgeon, nurse, or other technician providing medical care to a patient. In some embodiments, one or more steps of process 7900 may be performed by a computer or software running on a computer, and / or by a database, such as an electronic medical record database, and / or with the assistance of these. Process 7900 will be discussed in conjunction with the figures (for example, Figures 80 to 80L illustrating how the various steps of the process may be performed and / or their results).

[0198] Optionally, in step 7905, information regarding the pregnant patient may be received. This information may include, for example, the patient's laboratory findings, the patient's medical history, images of the patient's anatomical structures in which cervical length and / or dilation can be determined (e.g., ultrasound images of the pelvis and / or uterus), a visual examination of the patient's anatomical structures (e.g., vagina and / or cervix), and / or a digital examination of the patient's anatomical structures. Exemplary laboratory findings include, but are not limited to, levels of hormones present in the cervical-vaginal fluid (e.g., estrogen, progesterone, oxytocin, etc.) and / or fetal fibronectin (fFN) levels. Symbolic medical information that may be received includes, but is not limited to, age, the number of fetuses present in the patient's uterus (e.g., singleton, twins, triplets), history of preterm birth in the patient and / or the patient's family, history of pregnancy complications in the patient and / or the patient's family, history of cervical shortening, PROM, and / or PPROM in the patient and / or the patient's family, whether the patient has ever undergone cervical treatment (e.g., surgery, cervical cerclage, electrosurgical excision (LEEP), etc.), and / or whether the patient has one or more risk factors for pregnancy complications and / or high-risk pregnancies, such as advanced age, chronic inflammation, diabetes, and / or hypertension. Symbolic laboratory information that may be received and / or determined by performing Step 7905 includes, but is not limited to, a diagnosis of PROM and / or PPROM, and / or a determination that the cervix is ​​of a specific (e.g., shortened) length, the specific length may be less than 25 mm and / or within a range of lengths including 17–39 mm, 15–40 mm, or 10–45 mm.

[0199] If step 7905 is performed, in step 7910, it may be determined (using 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, or pelvic (e.g., prolapse) complications, and / or has indicators thereof, and / or otherwise is a good candidate for use of a cervical control system such as the cervical control system disclosed herein. If not, process 7900 proceeds to step 7915, where the patient may be monitored periodically, continuously, and / or as needed to reassess whether, for example, the use of a cervical control system could be beneficial to the patient (for example, the execution of step 7910 may be repeated).

[0200] If it is determined in step 7910 that a pregnant patient is at risk of premature birth, pregnancy complications, or pelvic (e.g., prolapse) complications, and / or has indicators thereof, and / or is otherwise a good candidate for use of a cervical control system, or if it is determined otherwise (e.g., by a clinician if steps 7905 and / or 7910 have not been performed), then the execution of process 7900 may proceed to step 7920 (or begin with step 7920), in which a speculum may be placed in the patient's vagina, and as a result the cervix may be visually observed, measured, and / or digitated to assess, for example, dilation, disappearance, integrity, sufficiency, length, and structural integrity. Figure 80A provides a sagittal view of an exemplary patient 8000 showing the patient's vaginal canal 1992, vaginal ore (vaginal opening) 1994, cervical shortening 1996, and external os (distal opening of the cervix) 1998, and Figure 80B provides a sagittal view of patient 8000 showing that the speculum is positioned within the vaginal canal 1992 (which may occur during the execution of step 7920), and as a result, for example, the cervix 1996 can be visually observed and / or swab to obtain a sample for clinical examination. After the speculum is positioned, the cervix can be examined with a finger to assess, for example, dilation, integrity, length, and / or disappearance.

[0201] If the cervix (e.g., cervix 1996) is easily accessible and / or has structural integrity (determination of step 7925), the speculum can be removed from the vaginal canal, and a cervical control system, such as the cervical control system disclosed herein, can be inserted into the vaginal canal (e.g., vaginal canal 1992) by fingers, for example, by inserting the cervix into the internal passage of the cervical control system, and fitted around the cervix (e.g., cervix 1996), as shown and described herein (step 7935). An example of how step 7935 is performed is shown in Figure 80C, which shows a clinician's hand inserting the cervical control system by fingers by performing step 7025.

[0202] Alternatively, in step 7925, the clinician may determine that the cervix is ​​difficult to reach and exhibits high flexibility, and therefore it may be better / more effective to first use a cervical stabilization system (e.g., forceps) to stabilize the cervix, as shown in Figure 80D, and then to position and / or use the cervical control system to draw the cervix into the internal passage of the cervical control system (step 7930). Step 7930 may be performed after the microscope inserted in step 7920 has been removed.

[0203] If, after performing step 7930 or 7935, the cervical control system is in place around the cervix, in step 7940 the clinician may reintroduce the microscope as shown in Figure 80E and inflate the inner cuff with an inflating medium (e.g., saline solution) as shown in Figure 80F (step 7945), Figure 80F showing how the inner cuff expands or stretches downward so that the inflation of the inner cuff pulls the cervix down and / or does not push the uterus up, as pushing the uterus up may cause the cervix to be pulled out of the inner cuff 1908 or the system.

[0204] Once the internal cuff is inflated (step 7945), the positioning balloon of the cervical control system is inflated with an inflation medium (e.g., saline solution) (step 7950) so that the positioning balloon, the cervical control system, and / or the cervix are positioned as desired, an example of which is shown in Figure 80G. As shown in Figure 80G, the positioning balloon can be inflated to tilt the cervix to a certain angle, for example, to reduce the pressure exerted on the cervix by the uterus. Figure 80G also shows the position of the cervix before tilting with dashed line 2032 and the position of the cervix after tilting with dashed line 2034. As indicated by the arrows in Figure 80G, after the positioning balloon is inflated, the cervix can be positioned further posteriorly. Figure 80G also shows the system with the positioning balloon positioned posteriorly. In this orientation, by inflating the positioning balloon, the cervical control system can push the upper part of the posterior portion of the cervix to move the rest of the cervix backward, as shown in Figure 80G, which may be done by pushing the upper part of the posterior side of the cervix, or in other cases, by rotating the system 180 degrees and pushing the lower part of the anterior side of the cervix (to tilt the cervix backward). Figure 80G shows a system with the positioning balloon positioned backward, but the positioning balloon 1918 can be positioned in any orientation to tilt the cervix in order to provide optimal support for the cervix and / or at the discretion of the physician. In the next step 7955, the clinician may remove the microscope, confirm the position with their fingers, and then push the valve housing 1960 (similar to the valve and valve housing 1360 described with reference to Figures 58-63) into the vaginal canal (step 7960), as shown, for example, in Figure 80H.

[0205] In some embodiments, the cervical control system may 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 systems disclosed herein may be used to treat symptoms of prolapse, including but not limited to bleeding, compression, pain, and incontinence (e.g., urinary incontinence). Such symptoms may also be treated by the present invention even without the underlying condition of pelvic organ prolapse. As an example, Figure 80I shows a sagittal view of patient 8001 in which the cervical control system 2200 is positioned around the patient's cervix and used to support uterine prolapse. System 2200 may be similar to, for example, systems 100, 500, 1000, 1100, 1300, 1400, 1500, 1600, and 1700 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 systems 100, 500, 1000, 1100, 1300, 1400, 1500, 1600, and 1700 described above, system 2200 in Figure 80I includes a main body 2202, a proximal opening 2204, a distal opening 2206, and an expandable positioning balloon 2218. As shown in Figure 80I, system 2200 can be positioned in an inverted orientation compared to the orientations 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. The inverted orientation of system 2200 orients system 2200 such that the cervix is ​​cupped inside the larger distal opening 2206 of system 2200 and closed by the inflation of the inner cuff of the cervical control system. The distal opening may have a cushioning layer, such as silicone gel, to increase the contact area and provide greater comfort to the user. The positioning balloon 2218 can be positioned in an anterior position as shown in Figure 80I.However, the positioning balloon 2218 can be positioned in any orientation that most promotes support to the uterus. When the cervical control system is placed within 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 prior to removal. The system 2200 can provide structurally semi-rigid support while also providing expandable components (such as positioning balloons) to accommodate anatomical diversity. Process steps 7905-7960 can be performed when used to treat and / or alleviate symptoms of prolapse, although in some cases the inner cuff may not need to be inflated (step 7945).

[0206] Additionally, or alternatively, process 7900 and / or its steps can be performed to reduce and / or treat the effects of PPROM or PROM. In these cases, placing the cervical control system around the patient's cervix can act to keep the cervix closed and prevent further outflow or leakage of amniotic fluid from the ruptured amnion.

[0207] FIG. 80J shows a sagittal view of a pregnant patient showing an intact membrane 1802 of the amnion filled with normal or clinically acceptable levels of amniotic fluid 1804. FIG. 80K shows a sagittal view of a pregnant patient who has experienced PPROM and has a ruptured membrane 1802 and a low level of amniotic fluid 1804 due to leakage of amniotic fluid from the ruptured membrane 180. FIG. 80L shows a sagittal view of a pregnant patient in which the cervix 101 of the pregnant patient is disposed within a cervical control system 1800, which may be similar to one or more of the cervical control systems described herein, and the cervix 101 of the pregnant patient is being compressed by the cervical control system 1800. The cervical control system 1800 may be disposed within the patient by performing one or more steps of process 7900. Compression of the cervix 101 may act to stop or reduce the flow rate of amniotic fluid leakage from the ruptured membrane 1802, thereby allowing replenishment of the amniotic fluid within the ruptured membrane 1802. In some embodiments, the main body of one or more of the cervical control systems disclosed herein may have a partial cubic shape, a pyramid shape, an oval shape with a partial oval or elliptical cross-section, an irregular three-dimensional shape with an asymmetric cross-section, or any other shape suitable for placement around the cervix and engagement with the vaginal wall.

[0208] In some cases, multiple material layers (e.g., multiple silicone layers) can be used to create a proximal balloon and / or a positioning balloon, and / or a cervical control system and / or the device itself. For example, embodiments shown in Figures 26-27 can utilize multiple material layers (e.g., silicone) to be bonded. In such cases, a plasma bonding process can be used to bond the layers of material. For example, a plasma can be applied to alter the surface energy / chemical properties of the material to facilitate adhesion with fully cured silicone. In other cases, silicone adhesives can be used. In some cases, adhesives may pose a risk of blocking channels for expansion, resulting in poor sealing properties. Therefore, in some cases, a plasma bonding process can be used, with no glue and / or other adhesives used at all, or with limited amounts of glue and / or other adhesives. In some embodiments, one, two, three, or more layers are used, and these layers can be bonded using a plasma bonding process.

[0209] In some embodiments, various different components and functions of the embodiments of the cervical control system described and illustrated herein may be adapted for use with any of the other embodiments disclosed herein. Thus, the various exemplary embodiments of the cervical control system detailed above provide a selectively adjustable cervical control system to control and / or support an inadequate cervix, reduce amniotic fluid leakage due to a ruptured amniotic membrane, promote the growth and / or regeneration of the cervical mucus plug, and / or support the pelvic organs, for example, to promote the prolongation of pregnancy to prevent preterm birth, reduce pregnancy complications, and improve patient (maternal and infant) outcomes. The cervical control system includes an upper or internal cuff for supporting, stretching, and / or contracting the patient's cervix to prevent the patient's cervix from further dilating, opening, or further shortening.

[0210] The internal cuffs disclosed herein may comprise a fixed-width or variable-width flexible membrane defining one or more internal chambers that are open to and / or configured to receive an inflatable medium. As the inflatable medium is inserted into and / or pushed into the internal chambers of the internal cuff, the size of their corresponding flexible membranes may expand to engage with and / or constrict, for example, the cervix placed therein. The expansion of the flexible membrane / internal cuff may be radial and / or distal. Sometimes, the internal cuffs disclosed herein may include a plurality of independently addressable (e.g., inflatable or deflated) expandable bladders to provide customizable support to the cervix based on the specific needs of the patient. In a preferred embodiment, the internal cuffs disclosed herein provide lateral and downward forces (e.g., away from the uterus) to the cervix, which may facilitate retention of the cervix within the internal cuff, extension of the cervix, and / or compression of the cervix (which may reverse and / or prevent cervical dilation). In some embodiments, the inner cuff is shaped and sized to allow blood flow from the upper cervix to the lower cervix protruding through the inner cuff.

[0211] The cervical control systems disclosed herein may include a lower balloon or positioning balloon of the cervical control system disclosed herein, which may be provided to seat or secure the body of the corresponding cervical control system to the patient's vaginal wall during use. The positioning balloon may include one or more independently addressable expandable bladders to provide customizable support and / or control over the cervix.

[0212] Kits comprising one or more of the cervical control systems described herein are also disclosed herein. Figure 81 provides a block diagram of the contents of an exemplary kit 8100, which includes, but is not limited to, one or more cervical control systems and / or systems 8105, a container for inflation medium 8110, an inflation medium delivery device 8115, one or more cervical stabilization devices 8120, one or more measuring devices 8125, one or more valve housings 8130, one or more tubes and / or catheters 8135, an microscope 8140, and a container for lubricant 8140. Importantly, not all embodiments of kit 8100 will include all of the components, parts, devices, and / or apparatus shown in Figure 81.

[0213] In some embodiments, Kit 8100 may include several different cervical control systems with different features that can be adapted to specific situations and / or patient anatomical characteristics. For example, the cervical control device and / or system 8105 may include small, medium, and large cervical control systems. Additionally or alternatively, the cervical control device and / or system 8105 may include a cervical control system adapted to treat PPROM and a cervical control system adapted to treat cervical shortening. Additionally or alternatively, the cervical control device and / or system 8105 may include a cervical control system with different internal cuff and / or positioning balloon features (e.g., clit size, number, and / or type).

[0214] In some embodiments, the inflation medium delivery device may, in some cases, be a pump or syringe that can be pre-filled with the inflation medium. In these cases, the kit 8100 may not include the inflation medium container 8110. An exemplary cervical stabilization device 8120 includes, but is not limited to, forceps and a tenacule. An exemplary measuring device 8125 measures the length or dilation of the cervix and is configured to include, but is not limited to, a ruler. In some cases, the tube and / or catheter 8135 may include tubes and / or catheters of various lengths, so that, for example, a clinician may select a tube of a particular length that allows easy access to the end of the tube / catheter extending from the vaginal opening when the cervical control system is in place. In this way, the selected tube and / or catheter may accommodate the patient's anatomical structure and / or the clinician's preference. 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 tube and / or catheter 8135 selected may depend on the type of cervical control system and / or system 8105 selected, 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 of the valve housings disclosed herein, and in some cases, multiple valve housings may be provided by the kit 8100, and as a result, the valve housing 8130 used may be configured to correspond to and / or cooperate with the selected tube and / or catheter 8135 or cervical control system and / or system 8105.

[0215] The lubricant container 8140 may hold a suitable lubricant that can make the use of one or more components of kit 8100 easier and / or more comfortable for the patient. In some cases, the lubricant may contain an active agent such as an antimicrobial agent and / or a pharmacological agent.

[0216] Modifications and alterations in the embodiments described herein can be made without departing from the principles of the Disclosure. Each of the embodiments and examples disclosed herein may be considered individually or in combination with other embodiments, examples, and variations of the Disclosure. Unless otherwise specified, none of the steps of the methods disclosed herein are limited to any particular order of execution.

[0217] The methods, devices, and systems described herein are capable of various modifications and alternative forms, specific examples of which are shown in the drawings and described in detail herein. However, it should be understood that the embodiments are not limited to any particular form or method disclosed, but rather are intended to cover the various examples and embodiments described, as well as modifications, equivalents, and alternatives that fall within the spirit and scope of the appended claims. Furthermore, any particular features, aspects, methods, properties, characteristics, qualities, attributes, elements, etc., disclosed herein in relation to a particular example may be used in all other examples described herein. None of the methods disclosed herein have to be performed in the order described. The use of sequential or chronological words such as “then,” “next,” “after,” and “following” is generally intended to facilitate the flow of text, and not to limit the order in which actions are performed, unless otherwise specified or understood otherwise in the context in which they are used. Thus, some examples may be performed using the sequence of actions described herein, while others may follow a different sequence of actions.

[0218] Conditional language used herein, such as in particular “can,” “may,” “may,” and “for example,” is generally intended to convey that some examples include certain features, elements, and / or states, while others do not, unless otherwise specifically stated or understood in the context in which they are used. Therefore, such conditional language is not generally intended to suggest that features, elements, blocks, and / or states are required in some way for one or more examples, or that one or more examples necessarily include logic for determining whether these features, elements, and / or states are included or should be performed in any particular example, with or without input or prompting from the author. Where a device, system, and / or method “companies” certain features or steps, such device, system, and / or method may “substantially consist of” such features or steps, if identified so in the claims.

[0219] The methods disclosed herein may include certain actions performed by experts. However, the methods may also include instructions, express or implied, for such actions by a user or a third party. For example, an action such as "positioning a device" may include "instructing the placement of a device."

[0220] The scope disclosed herein includes all overlaps, sub-scopes, and combinations thereof. Words such as “at most,” “at least,” “greater than,” “less than,” and “between” include the stated figures. Numbers preceded by terms such as “about” or “approximately” include the stated figures and should be interpreted on a case-by-case basis (e.g., as accurately as is reasonable depending on the circumstances, e.g., ±5%, ±10%, ±15%). For example, “about 10.16 cm (4 inches)” includes “10.16 cm (4 inches).” Phrases preceded by terms such as “substantially” include the stated phrase and should be interpreted on a case-by-case basis (e.g., as reasonably as is reasonable depending on the circumstances). For example, “substantially linear” includes “linear.” Unless otherwise stated, all measurements are taken under standard conditions, including temperature and pressure.

[0221] The phrase "at least one" is intended to mean that you need at least one item from the following list, not that you need one of each type of item from each item in the following list. 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.

[0222] The following are excerpts from the attached drawings, specifically those shown in a comparative format in the international application for this application, PCT / US2024 / 018224 (whose international publication is WO2024 / 182773). [Figure 12-13 shows the contrasting states] TIFF2026510572000002.tif241161

Claims

1. In the cervical control system, A body configured for insertion into the patient's vagina, wherein its internal passage is capable of receiving the insertion of the patient's cervix, and the body is, The internal passage configured to receive the patient's cervix therein, An expansion medium conduit disposed within the side wall of the main body, wherein the first end of the expansion medium conduit is open to an internal chamber defined by the flexible membrane of the inner cuff of the cervical control system and is configured for fluid communication with the internal chamber, and the second end of the expansion medium conduit has an inlet configured to receive fluid for communication of the inner cuff to the internal chamber via the first end of the expansion medium conduit. The main unit is equipped with, The inner cuff, wherein the inner cuff is The flexible membrane defining the internal chamber therein, the flexible membrane is configured to expand when an expansion medium is added to the internal chamber via the first end of the expansion medium conduit. The inner cuff and A cervical control system equipped with [the following features].

2. The cervical control system according to claim 1, wherein the direction of expansion of the flexible membrane is radially inward toward the inner passage, and as a result, the outer surface of the inner cuff contacts the cervix located within the inner passage and compresses the cervix.

3. The cervical control system according to claim 1 or 2, wherein the flexible membrane expands distally, thereby further drawing the cervix into the internal passage.

4. The cervical control system according to claim 1, 2, or 3, wherein the expansion of the flexible membrane extends the cervix within the internal passage.

5. The cervical control system according to any one of claims 1 to 4, wherein the expansion of the flexible membrane adjusts at least one of the angle of orientation of the cervix, the degree of cervical expansion, and the length of the cervix.

6. The cervical control system according to any one of claims 1 to 5, wherein as the volume of the expanding medium added to the internal chamber increases, the compressive force applied to the cervix by the expanding flexible membrane also increases.

7. The cervical control system according to any one of claims 1 to 6, wherein as the volume of the expansion medium added to the internal chamber increases, the stretching force applied to the cervix by the expanded flexible membrane also increases.

8. The cervical control system according to any one of claims 1 to 7, wherein the expansion of the flexible membrane causes the cervix to twist.

9. The cervical control system according to any one of claims 1 to 8, wherein the thickness of the flexible membrane is constant throughout the entire flexible membrane.

10. The cervical control system according to any one of claims 1 to 9, wherein the thickness of the flexible membrane is variable throughout the entire flexible membrane.

11. The cervical control system according to claim 10, wherein when the inner cuff is in a neutral position, the apex portion of the flexible membrane is thicker than the proximal portion and the distal portion of the flexible membrane.

12. The cervical control system according to claim 10 or 11, wherein the thickness of the apex portion of the flexible membrane decreases as the inner cuff expands.

13. The cervical control system according to any one of claims 1 to 12, wherein when the inner cuff is in a neutral position, the length of the proximal portion of the flexible membrane is longer than the length of the distal portion of the flexible membrane.

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

15. The cervical control system according to any one of claims 1 to 14, wherein a portion of the outer surface of the inner cuff is coated with at least one of a drug, an antibacterial agent, a friction enhancer, and an adhesive.

16. The cervical control system according to any one of claims 1 to 15, wherein the flexible membrane includes a buckle configured to assist in the expansion of the flexible membrane when the internal chamber is inflated.

17. The cervical control system according to any one of claims 1 to 16, wherein the flexible membrane is further configured to contract when the expansion medium is withdrawn from the internal chamber.

18. The cervical control system according to claim 17, wherein the degree of expansion or contraction of the flexible membrane corresponds to at least one of the following: clinical need, orientation of the cervix, orientation of the patient's uterus, degree of cervical expansion, length of the cervix, degree of cervical softness, and status of the patient's amniotic membrane.

19. The cervical control system according to any one of claims 1 to 18, wherein when an expanding medium is added to the internal chamber, the flexible membrane expands in a direction away from the patient's uterus and radially toward the patient's cervix.

20. The aforementioned inner cuff is, Multiple flexible membranes, each of which defines a separate internal chamber and is in fluid communication with an expansion medium conduit, and is configured to expand when an expansion medium is added to each of its internal chambers. A cervical control system according to any one of claims 1 to 19, further comprising the above.

21. The aforementioned flexible film is The first recess and A second recess, the second recess being located approximately 180 degrees opposite to the first recess, and Furthermore, The cervical control system according to any one of claims 1 to 20, wherein the degree of expansion of the first recess and the second recess is less than the degree of expansion of the rest of the flexible membrane when the inner cuff is in an expanded state after the addition of the expansion medium to the inner chamber.

22. The cervical control system according to claim 21, wherein at least one of the first recess and the second recess is located within the internal passage and is sized and positioned to avoid compression of the cervical blood vessels when the internal cuff is inflated.

23. One or more cleats disposed on the outer surface of the flexible membrane, which does not include the first recess or the second recess, and which are configured to press in and hold the cervix. The cervical control system according to claim 21 or 22, further comprising the above.

24. One or more cleats disposed on the outer surface of the flexible membrane, configured to press in and hold the cervix A cervical control system according to any one of claims 1 to 23, further comprising the above.

25. The cervical control system according to claim 24, wherein one or more cleats are configured to increase the coefficient of friction between the cervix and the flexible membrane.

26. The cervical control system according to claim 24 or 25, wherein one or more cleats have a semicircular profile, a rectangular profile, a parallelogram profile, a triangular profile, an oval profile, a trapezoidal profile, or an irregular radial profile.

27. The cervical control system according to any one of claims 24 to 26, wherein one or more cleats have at least one of the following profiles: a semicircular profile, a rectangular profile, a parallelogram profile, a triangular profile, an oval profile, a trapezoidal profile, a hooked profile, a curved profile, and a profile with an irregular cross-section.

28. The cervical control system according to any one of claims 24 to 27, wherein the one or more cleats have at least one of the following shapes: semicircular, rectangular, parallelogram, triangular, oval, trapezoidal, or irregular elevation.

29. An array of cleats arranged in multiple rows and extending from the outer surface of the flexible membrane. A cervical control system according to any one of claims 1 to 28, further comprising the above.

30. The cervical control system according to any one of claims 1 to 29, wherein the second end of the expansion medium conduit is attached to a valve.

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

32. The cervical control system according to claim 31, wherein the valve housing includes a pressure sensor.

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

34. The cervical control system according to 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-operated check valve, a check valve with a polycarbonate body, and a check valve.

35. The cervical control system according to claim 30, wherein the valve is configured to receive the insertion of an expansion medium source therein, and to connect the expansion medium from the expansion medium source to the expansion medium conduit and then to the internal chamber.

36. The cervical control system according to any one of claims 1 to 35, wherein the main body further comprises a valve configured to fluidly communicate with the second end of the expansion medium conduit.

37. The cervical control system according to any one of claims 1 to 36, wherein the expansion medium conduit extends outside the main body so that it can be accessed from outside the vaginal opening of the patient.

38. The cervical control system according to any one of claims 1 to 37, wherein at least one of the valve and the valve housing is removably attached to the second end of the expansion medium conduit.

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

40. A positioning balloon disposed on the outer surface of the main body, which is expandable when an expansion medium conduit is placed inside it. A cervical control system according to any one of claims 1 to 39, further comprising the above.

41. The expansion medium conduit is a first expansion medium conduit, the flexible membrane is a first flexible membrane, and the cervical control system is A second expansion medium conduit disposed within the side wall of the main body, wherein the first end of the second expansion medium conduit is configured to open into an internal chamber of the positioning balloon defined by the flexible membrane of the positioning balloon and to be in fluid communication with the internal chamber of the positioning balloon, and the second end of the second expansion medium conduit has an inlet configured to receive an expansion medium for communication with the internal chamber of the positioning balloon via the first end of the second expansion medium conduit, The positioning balloon, A second flexible membrane defining the internal chamber of the positioning balloon therein, wherein the second flexible membrane is configured to expand when an expansion medium is inserted into the internal chamber of the positioning balloon. The positioning balloon and A cervical control system according to any one of claims 1 to 40, further comprising the above.

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

43. The cervical control system according to claim 40, 41, or 42, wherein the positioning balloon surrounds a part of the outer surface of the main body.

44. The cervical control system according to claim 40, wherein the positioning balloon surrounds less than 50 percent of the distal portion of the outer surface of the main body.

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

46. The cervical control system according to any one of claims 40 to 45, wherein the positioning balloon is arranged on the side surface of the main body.

47. The positioning balloon is a first positioning balloon positioned on the side of the main body, and the cervical control system is A second positioning balloon located at the distal end of the main body. A cervical control system according to any one of claims 40 to 46, further comprising the above.

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

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

50. The cervical control system according to claim 49, wherein the valve housing includes a pressure sensor.

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

52. The cervical control system according to claim 48, wherein the valve attached to the second end of the second expansion 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-operated 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 expansion medium conduit is configured to receive the insertion of an expansion medium source and to connect the expansion medium from the expansion medium source to the second expansion medium conduit and to the internal chamber of the positioning balloon.

54. The cervical control system according to any one of claims 1 to 53, wherein the second expansion medium conduit extends outside the main body so that it can be accessed from outside the vaginal opening of the patient.

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

56. The cervical control system according to any one of claims 1 to 55, wherein the main body has a circular horizontal cross-sectional shape.

57. The cervical control system according to any one of claims 1 to 56, wherein the main body has an oval horizontal cross-sectional shape.

58. The cervical control system according to any one of claims 1 to 57, wherein the position of the radius center of the inner cuff is offset from the position of the radius center of the main body.

59. The cervical control system according to any one of claims 1 to 58, wherein the main body includes a relief notch configured to allow at least one of bending the main body and expanding the main body.

60. The cervical control system is An annular ring positioned on the proximal edge of the main body, near the proximal side of the inner cuff, and including a tapered edge configured to guide the cervix into the internal passage. A cervical control system according to any one of claims 1 to 59, further comprising the above.

61. The cervical control system according to any one of claims 1 to 60, wherein the cervical control system is integrally molded.

62. The flexible film is formed to include a first extension surrounding the proximal edge of the flexible film and a second extension surrounding the distal edge of the flexible film. The body is molded to include a first groove sized, positioned, and configured to receive the first extension, and a second groove sized, positioned, and configured to receive the second extension, wherein the inner cuff is formed when the first extension is positioned in the first groove and the second extension is positioned in the second groove. The cervical control system according to claim 61.

63. A liquid delivery device comprising at least one port configured to allow liquid to seep from the liquid delivery device to the cervix, located near the internal passage and in communication with a conduit for liquid, the liquid delivery device A cervical control system according to any one of claims 1 to 62, further comprising the above.

64. The cervical control system according to claim 63, wherein the liquid comprises at least one of a drug, an antibacterial agent, and a hormone.

65. The cervical control system according to claim 63 or 64, wherein the conduit is the expansion medium conduit that communicates with the internal chamber.

66. The cervical control system according to claim 63 or 64, wherein the conduit is a liquid delivery conduit located within the main body or fixed to the main body.

67. A body defining an internal passage for receiving the cervix, comprising an upper and lower portion defining a proximal opening and a distal opening to the internal passage, respectively, and an outer surface for engaging with the vaginal wall, An inner cuff, connected to the main body at the proximal opening and configured to surround at least a portion of the cervix, wherein the inner cuff is configured to expand from a neutral state to an expanded state, and in the expanded state, the inner cuff is configured to engage with at least a portion of the cervix, A positioning balloon disposed on either or both of the outer portion of the main body and the lower portion of the main body near the distal opening, wherein the positioning balloon is disposed around a portion of the circumference of the main body and is configured to expand away from the axis of the distal opening and expand toward the vaginal wall into the vaginal wall, the positioning balloon is expandable from a neutral state to an expanded state, and in the expanded state, the outer circumference of the positioning balloon is enlarged compared to its outer circumference in the neutral state, and A cervical control system equipped with [the following features].

68. The cervical control system according to claim 67, wherein the positioning balloon has an inferior arc shape and is arranged around the circumference of the main body at less than 180 degrees.

69. The cervical control system according to claim 67, wherein the positioning balloon has an arc shape and is arranged around the circumference of the main body at a rate exceeding 180 degrees.

70. The cervical control system according to claim 67, 68, or 69, wherein, in the expanded state, the radius of the cervical control system from the axis of the distal opening to the outer circumference of the positioning balloon is greater than the radius of the cervical control system from the axis of the distal opening to the outer circumference of the main body in a portion of the circumference of the main body without the positioning balloon.

71. The cervical control system according to any one of claims 67 to 70, wherein the positioning balloon has a non-uniform wall thickness configured to control the expansion of the positioning balloon so that it expands into the vaginal wall toward the vaginal wall away from the axis of the distal opening.

72. The cervical control system according to claim 70, wherein the positioning balloon has a first wall thickness on the proximal side of the positioning balloon, a second wall thickness on the distal side of the positioning balloon, and a third wall thickness on the outer circumference of the positioning balloon extending between the first wall and the second wall.

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

74. The cervical control system according to any one of claims 67 to 73, wherein the main body has a hemispherical shape, and the proximal opening defines a smaller area than the distal opening.

75. The cervical control system according to any one of claims 67 to 74, further comprising a cleat disposed along the inner circumference of the inner cuff for grasping the outer side of the cervix.

76. The cervical control system according to any one of claims 67 to 75, wherein the internal cuff is configured to expand substantially radially inward toward the axis of the proximal opening when expanded.

77. The cervical control system according to any one of claims 67 to 76, wherein the inner cuff is configured to expand both radially inward and downward, away from the cross-section of the proximal opening and away from the uterus, as the inner cuff expands around the cervix during expansion.

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

79. The cervical control system according to claim 77 or 78, wherein the inner cuff comprises a first wall thickness on the proximal side of the inner cuff, a second wall thickness on the distal side of the inner cuff, and a third wall thickness on the inner surface of the inner cuff 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 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 cuff has an inner wall configured to form an angle with respect to the axis of the proximal opening.

82. The cervical control system according to claim 78 or 79, wherein the inner cuff comprises an inner wall facing the inner wall of the inner cuff, and the inner wall is configured to be parallel to the axis of the proximal opening.

83. The cervical control system according to any one of claims 67 to 82, wherein the inner cuff comprises an expandable portion adjacent to the recess, the expandable portion being further selectively extendable into the internal passage beyond the recess.

84. The cervical control system according to claim 82 or 83, wherein the inner cuff has an uneven wall thickness, and the recess has a wall thickness greater than the expandable portion.

85. The cervical control system according to any one of claims 67 to 84, further comprising an expansion medium conduit having fluid communication with the first and / or positioning balloon, and a valve having fluid communication with the expansion medium conduit on the opposite side of the first and / or positioning balloon.

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

87. The cervical control system according to claim 82 or 83, wherein the inner cuff comprises at least two of the recesses and at least two of the expandable portions arranged alternately with respect to the recesses.

88. A pump and a fluid reservoir disposed within the main body, wherein the pump is in fluid communication with the fluid reservoir, the fluid reservoir is in fluid communication with at least one of the inner cuff and the positioning balloon, and the pump is adapted to move fluid between the fluid reservoir and at least one of the inner cuff and the positioning balloon to inflate and deflate the respective inner cuff or the positioning balloon. A cervical control system according to any one of claims 67 to 87, further comprising the above.

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

90. In a cervical control system for placement inside the vagina, the cervical control system is A hemispherical body defining an internal passage for receiving the cervix, the body comprising an upper and lower portion defining a proximal opening and a distal opening, respectively, and an outer surface for engaging with the vaginal wall to support the cervical control system near the cervix, the hemispherical body is An inner cuff, which is connected to the main body at the proximal opening and configured to surround at least a portion of the cervix, A positioning balloon disposed on either or both of the outer portion of the main body and the lower portion of the main body near the distal opening, wherein the positioning balloon is configured to expand away from the axis of the distal opening and expand toward the vaginal wall into the vaginal wall, the positioning balloon is expandable from a neutral state to an expanded state, and in the expanded state, the outer circumference of the positioning balloon is enlarged compared to its outer circumference in the neutral state, A hemispherical body equipped with, An expansion medium conduit having 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 comprising a first end configured to be in fluid communication with the second end of the expansion medium conduit, and a second end opposite to the first end configured to receive a portion of an expansion device that is operable to inflate the first and / or positioning balloon without removing the cervical control system from the patient's vagina, A valve housing comprising a first end configured to receive the expansion medium conduit, and a second end including an opening configured to surround the first end of the valve. A cervical control system equipped with [the following features].

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

92. The cervical control system according to claim 90 or 91, wherein the positioning balloon is arranged around a part of the circumference of the main body.

93. The cervical control system according to any one of claims 90 to 92, wherein the valve housing comprises a pressure gauge configured to provide a tactile and / or visual indicator of the pressure in the first and / or positioning balloon.

94. The cervical control system according to claim 92 or 93, wherein the pressure gauge comprises a pressure balloon configured to be inflated in stages to indicate how much the pressure has increased within the cervical control system.

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

96. In a method for supporting and strengthening the cervix, the method is: The method involves placing a cervical control system around the cervix of a patient, wherein the cervical control system is A body defining an internal passage for receiving the cervix, comprising an upper and lower portion defining a proximal opening and a distal opening to the internal passage, respectively, and an outer surface for engaging with the vaginal wall, An inner cuff, which is connected to the main body at the proximal opening and configured to surround at least a portion of the cervix, A positioning balloon disposed on one or both of the outer portion of the main body and the lower portion of the main body near the distal opening, wherein the positioning balloon is disposed around a portion of the circumference of the main body and To have, to arrange, The process involves inflating the inner cuff from a neutral state to an expanded state in which the inner cuff engages with at least a portion of the cervix. The positioning balloon is inflated to expand away from the axis of the distal opening and toward the vaginal wall into the vaginal wall, wherein the positioning balloon is expandable from a neutral state to an expanded state, and in the expanded state, the outer circumference of the positioning balloon is enlarged compared to its outer circumference in the neutral state. Methods that include...

97. The method according to claim 96, wherein the cervical control system further comprises an expansion medium conduit that is in fluid communication with the first and / or positioning balloon, and a valve that is in fluid communication with the expansion medium conduit on the opposite side of the first and / or positioning balloon.

98. The method according to claim 97, further comprising connecting an inflation device to the valve to inflate the first and / or positioning balloon without removing the cervical control system from the patient's vagina.

99. The method according to any one of claims 96 to 98, wherein the positioning balloon has an inferior arc shape disposed around the circumference of the main body at less than 180 degrees.

100. The method according to any one of claims 96 to 98, wherein the positioning balloon has an arc shape arranged around the circumference of the main body at a rate exceeding 180 degrees.

101. The method according to any one of claims 96 to 100, wherein the second cuff has a non-uniform wall thickness configured to control the expansion of the positioning balloon so as to expand into the vaginal wall toward the vaginal wall away from the axis of the distal opening.

102. In a method for treating prolapse, the method is: The cervical control system is positioned around the cervix of the patient, and the cervical control system is A body defining an internal passage for receiving the cervix, comprising an upper and lower portion defining a proximal opening and a distal opening to the internal passage, respectively, and an outer surface for engaging with the vaginal wall, A positioning balloon disposed on one or both of the outer portion of the main body and the lower portion of the main body near the distal opening, wherein the positioning balloon is disposed around a portion of the circumference of the main body and To have, to arrange, The positioning balloon is inflated to expand away from the axis of the distal opening and toward the vaginal wall into the vaginal wall, wherein the positioning balloon is expandable from a neutral state to an expanded state, and in the expanded state, the outer circumference of the positioning balloon is enlarged compared to its outer circumference in the neutral state. Methods that include...

103. The method according to claim 102, wherein the support system further comprises an expansion medium conduit that is in fluid communication with the positioning balloon, and a valve that is in fluid communication with the expansion medium conduit on the opposite side of the positioning balloon.

104. The method according to claim 103, further comprising connecting an inflation device to the valve and inflating the positioning balloon without removing the cervical control system from the patient's vagina.

105. The method according to any one of claims 102 to 104, wherein the positioning balloon has an inferior arc shape disposed around the circumference of the main body at less than 180 degrees.

106. The method according to any one of claims 102 to 105, wherein the positioning balloon has an arc shape that is arranged around the circumference of the main body at a rate exceeding 180 degrees.

107. The method according to any one of claims 102 to 106, wherein the positioning balloon has a non-uniform wall thickness configured to control the expansion of the positioning balloon so as to expand into the vaginal wall toward the vaginal wall away from the axis of the distal opening.

108. A body defining an internal passage for receiving the cervix, comprising an upper and lower portion defining a proximal opening and a distal opening to the internal passage, respectively, and an outer surface for engaging with the vaginal wall, An inner cuff, connected to the main body at the proximal opening and configured to surround at least a portion of the cervix, wherein the inner cuff is configured to expand from a neutral state to an expanded state, and in the expanded state, is configured to engage with at least a portion of the cervix, and the inner cuff has a non-uniform wall thickness configured to control the expansion of the inner cuff, and the inner cuff is configured to expand both radially inward and downward, away from the cross-section of the proximal opening and away from the uterus, as the inner cuff expands around the cervix during expansion, A positioning balloon disposed on either or both of the outer portion of the main body and the lower portion of the main body near the distal opening, wherein the positioning balloon is disposed around a portion of the circumference of the main body and is configured to expand away from the axis of the distal opening and expand toward the vaginal wall into the vaginal wall, the positioning balloon is expandable from a neutral state to an expanded state, and in the expanded state, the outer circumference of the positioning balloon is enlarged compared to its outer circumference in the neutral state, and Equipped with, A cervical control system comprising a positioning balloon having a subarc shape disposed around the circumference of the main body at less than 180 degrees, and the positioning balloon having a non-uniform wall thickness configured to control the expansion of the positioning balloon so as to expand into the vaginal wall toward the vaginal wall away from the axis of the distal opening.

109. In a method for supporting and strengthening the cervix, the method is: The method involves placing a cervical control system around the cervix of a patient, wherein the cervical control system is A body that defines an internal passage for receiving the cervix, comprising an upper portion and a lower portion that define a proximal opening and a distal opening to the internal passage, respectively, and an outer surface for engaging with the vaginal wall, An inner cuff, which is connected to the main body at the proximal opening and configured to surround at least a portion of the cervix, A positioning balloon disposed on either or both of the outer portion of the main body and the lower portion of the main body near the distal opening, wherein the positioning balloon is disposed around a portion of the circumference of the main body and has a subarc shape disposed around less than 180 degrees of the circumference of the main body. To have, to arrange, The process of inflating the inner cuff from a neutral state to an expanded state in which the inner cuff engages with at least a portion of the cervix, wherein the inner cuff has a non-uniform wall thickness configured to control the expansion of the inner cuff, and as the inner cuff expands around the cervix, the inner cuff expands both radially inward and downward, away from the cross-section of the proximal opening and away from the uterus. The method of inflating the positioning balloon to expand away from the axis of the distal opening and into the vaginal wall toward the vaginal wall, wherein the positioning balloon is expandable from a neutral state to an expanded state, and in the expanded state, the outer circumference of the positioning balloon is enlarged compared to its outer circumference in the neutral state, and the positioning balloon has a non-uniform wall thickness configured to control the expansion of the positioning balloon to expand away from the axis of the distal opening toward the vaginal wall toward the vaginal wall and into the vaginal wall, and Methods that include...

110. The use of any of the cervical control systems according to claims 1 to 109, wherein the cervical control system is used to delay labor.

111. The use of any of the cervical control systems according to claims 1 to 110, wherein the cervical control system is used to support a weak cervix or to treat cervical incompetence.

112. The use of any of the cervical control systems according to claims 1 to 111, wherein the cervical control system is used to treat prolapse.

113. The use of any of the cervical control systems according to claims 1 to 112, wherein the cervical control system is used to treat one or more of the following: incontinence, pain or pressure of the pelvic organs, bleeding, and bladder symptoms.

114. A kit comprising a cervical control system according to any one of claims 1 to 113 and an expansion medium delivery device.

115. A method for operating any of the systems or devices described in any of claims 1 to 114.

116. Any of the cervical control systems described in claims 1 to 115, Expansion medium source, A valve housing configured to communicate fluidly with the expansion medium conduit of the cervical control system A kit that includes the following:

117. Microscope The kit according to claim 116, further comprising:

118. Measuring devices The kit according to claim 116 or 117, further comprising:

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

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

121. Cervical stabilization device The kit according to any one of claims 116 to 120, further comprising:

122. At least one of forceps and tenacula The kit according to any one of claims 116 to 121, further comprising:

123. A cervical control system, A body configured for insertion into the patient's vagina, wherein its internal passage can accept the insertion of the patient's cervix, and the body is, An internal passage designed to receive the patient's cervix, An expansion medium conduit disposed within the side wall of the main body, wherein the first end of the expansion medium conduit is open to an internal chamber defined by the flexible membrane of the inner cuff of the cervical control system and is configured for fluid communication with the internal chamber, and the second end of the expansion medium conduit has an inlet configured to receive fluid for communication of the inner cuff to the internal chamber via the first end of the expansion medium conduit. The main unit, equipped with The inner cuff, wherein the inner cuff is The flexible membrane defining the internal chamber therein, the flexible membrane is configured to expand when an expansion medium is added to the internal chamber via the first end of the expansion medium conduit. The inner cuff A cervical control system equipped with, Expansion medium source, A valve housing configured to communicate fluidly with the expansion medium conduit of the cervical control system A kit that includes the following:

124. Microscope The kit according to claim 123, further comprising:

125. Measuring devices The kit according to claim 123 or 124, further comprising:

126. The kit according to any one of claims 123 to 125, wherein the measuring device is configured to measure the length of the cervix.

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

128. Cervical stabilization device The kit according to any one of claims 123 to 127, further comprising:

129. At least one of forceps and tenacula The kit according to any one of claims 123 to 128, further comprising:

130. A method for arranging any of the cervical control systems described in claims 1 to 129, wherein the method is: The aforementioned cervical control system is inserted into the patient's vagina, The patient's cervix is ​​positioned within the internal passage of the cervical control system, To fix the cervix within the internal passage, the inner cuff is inflated. Methods that include...

131. The method according to claim 130, wherein inflating the inner cuff compresses and closes the cervix.

132. The method according to claim 130 or 131, wherein inflating the inner cuff extends and closes the cervix.

133. The method according to claims 130 to 132, wherein inflating the inner cuff promotes the growth of the cervical mucus plug.

134. The cervical control system includes a positioning balloon, and the method is To adjust the angle of the cervix, the positioning balloon is inflated. The method according to any one of claims 130 to 133, further comprising:

135. The cervical control system includes a positioning balloon, and the method is To fix the cervical control system inside the vagina of the patient, the positioning balloon is inflated. The method according to any one of claims 130 to 134, further comprising:

136. The cervical control system includes a positioning balloon, and the method is To extend the cervix, the positioning balloon is inflated. The method according to any one of claims 130 to 135, further comprising:

137. The cervical control system includes a positioning balloon, and the method is To compress and close the cervix, the positioning balloon is inflated. The method according to any one of claims 130 to 136, further comprising:

138. The method according to any one of claims 130 to 137, wherein the cervical control system is configured in accordance with the patient being associated with risk factors for premature labor.

139. The method according to any one of claims 130 to 138, wherein the cervical control system is configured in accordance with the patient being associated with an indicator of early labor.

140. The method according to any one of claims 130 to 139, wherein the cervical control system is configured in response to the patient being diagnosed with cervical shortening.

141. The method according to any one of claims 130 to 140, wherein the cervical control system is configured in accordance with the patient being associated with an indicator of pelvic organ prolapse.

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

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