Cervical control systems, main bodies of cervical control systems, and methods for inserting and using same

Abstract

Systems, devices, and methods are provided that control, support, and / or elongate a cervix to treat pregnancy complications and / or delay an onset of labor so that a gestational period for a fetus may be extended, thereby preventing preterm labor and delivery of the fetus. The systems and devices may be made by assembling a molded component configured to have a main body with a groove therein and a flange. During manufacturing, the flange may be inserted into the groove and bonded therein to form a cervical cuff balloon and a positioning balloon may be attached to an external surface of the main body. The molded component may further include an inflation media conduit in communication with the cervical cuff balloon.

Description

CERVICAL CONTROL SYSTEMS, MAIN BODIES OF CERVICAL CONTROLSYSTEMS, AND METHODS FOR INSERTING AND USING SAMERELATED APPLICATION

[0001] This international, PCT, application claims priority to United States Provisional Patent Application Number 63 / 689,808, filed 02 September 2024 and entitled “CERVICAL CONTROL DEVICES, CERVICAL CONTROL SYSTEMS, AND METHODS FOR INSERTING AND USING SAME” and is incorporated herein in its entirety.FIELD OF THE INVENTION

[0002] The present disclosure is directed to reproductive, gestational, and prenatal health, and in particular, to devices, methods, and systems that control a cervix to, for example, prevent preterm birth, prevent and / or mitigate pregnancy complications, and / or treat pelvic organ prolapse.BACKGROUND

[0003] The most common reason for infant mortality is complications due to preterm labor. Several factors contribute to early births, including commonly, cervical insufficiency, otherwise referred to medically as a “short cervix”, and / or premature rupture of membranes (PROM) or preterm premature rupture of membranes (PPROM). When a short cervix occurs in singleton pregnancies (i.e. single fetus pregnancies), a common intervention method includes a suture(s) placed in the cervix in attempts to delay birth, known as a cervical cerclage. Generally, interventions for cervical insufficiency in multiple gestations (i.e. multiple fetus pregnancies) are limited and may provide only limited efficacy.

[0004] Another intervention for a short cervix is the application of vaginal progesterone to the cervix so that it may maintain its length and structure. However, vaginal progesterone cannot remain in place for an extended period of time due to vaginal discharge flushing out the medication over time. Furthermore, application of vaginal progesterone to the cervix is an invasive procedure requiring transvaginal access by clinicians.SUMMARY

[0005] The systems and devices disclosed herein may be made and / or manufactured using an assembly for molding a main body of a cervical control system, that in some embodiments may be a one-piece main body. The assembly includes at least three pieces, a top mold, a bottom mold, and a waist mold configured to be positioned between, and cooperate with, the top and bottom molds. The waist mold may include a groove feature configured to form a groove within a molded main body, wherein negative space between the top mold and waist mold is configured to generate a flange and a flange extension of the main body, the flange extension being configured for insertion into and / or attachment to the groove of the main body, thereby forming a cervical cuff balloon of the main body.

[0006] The waist mold may further include a positioning balloon feature (e.g., a groove and / or extension) sized, configured, and positioned to generate a feature in the main body configured to cooperate with (e.g., attached to) a flexible membrane to create a positioning balloon.

[0007] The bottom mold may include a feature, or combination of features (e.g., a fluid conduit extension) configured to cooperate with a corresponding fluid conduit feature, or combination of fluid conduit features of the waist mold to form, for example, one, two, or three fluid conduit(s) in the main body. When a single fluid conduit is formed, it may be in communication with the cervical cuff balloon and, in some embodiments, a positioning balloon. When a two fluid conduits are formed, a first fluid conduit may be in communication with the cervical cuff balloon and a second fluid conduit may be in communication with a positioning balloon. When a three fluid conduits are formed, a first fluid conduit may be in communication with the cervical cuff balloon, a second fluid conduit may be in communication with a positioning balloon, and a third fluid conduit may be in communication with a channel of the main body configured to deliver a medial substance (e.g., saline, medication, hormones, etc.) to cervical tissue. Optionally, the waist and / or bottom mold may also include one or more inlet feature(s) configured to form an inlet in communication with the first, second, or third fluid conduit(s) of the main body. The inlet(s) may be configured to enable attachment of a tube to the main body. When there is one fluid conduit and one inlet formed in a main body, the tube may be a single lumen tube; when there are two fluid conduits and a corresponding two inletsformed in a main body, the tube may be a bi-lumen tube, with one first inlet being configured for communication with a first lumen of the bi-lumen tube and a second inlet being configured for communication with a second lumen of the bi-lumen tube.

[0008] The mold assembly may also include and / or be configured to cooperate with one or more alignment mechanism(s) (e.g., pins, rods, clamps, presses, etc.) configured to align the top, waist, and / or bottom molds prior to, for example, adding material(s) with which to form the main body and / or cure the main body.

[0009] The mold assembly may be used to manufacturing a cervical control system and / or a main body of a cervical control system by adding material to the assembly so that the material fills negative space between the top, waist, and bottom molds, allowing the material to cure, or harden, unmolding the main body (once cured) from the assembly and forming the cervical cuff balloon by inserting the flange extension into the groove. Exemplary materials used to manufacture the cervical control system include, but are not limited to, silicone, plastic, and polymers. When the waist and / or bottom mold includes one or more fluid conduit extensions the method may further include coupling a tube and / or a lumen of the tube to the one or more fluid conduits of the main body. When the bottom mold includes one or more inlet feature(s), the method may further include coupling a first end of a tube and / or a lumen of the tube to the one or more inlets of the main body so that the lumen(s) are in communication with a fluid conduit. In some cases, the method may further include coupling a valve and / or valve housing to a second end of the tube. Manufacturing of the cervical control system and / or a main body of a cervical control system may further include attaching a positioning balloon membrane to the main body. In some cases, the positioning balloon membrane may be attached to the main body via a feature of the main body (e.g., a groove) configured to accept insertion of the flexible membrane and / or attach to the flexible membrane.

[0010] In some embodiments, a method for manufacturing a cervical control system and / or a main body of a cervical control system may include adding material to a mold configured to generate the main body of the cervical control system, the mold including features to generate corresponding features of the main body including an interior passageway and a component configured to be assembled to form a cervical cuff balloon. When the material has cured, the main body may be unmolded from the mold and it may include the interior passageway and the component configured to be assembled to form an inflatable cervical cuff.Manufacturing of the main body may further include forming the cervical cuff balloon using the component configured to be assembled to form a cervical cuff balloon.

[0011] In some embodiments, the mold features may include a groove portion configured to generate a groove in the main body that cooperates with, and accepts, insertion of a flange extension of the main body and a flange extension portion configured to generate the flange extension so that a molded main body includes the groove and the flange extension, wherein the cervical cuff balloon is formed by inserting the flange extension into the groove and causing the flange to be bonded (e.g., chemical, mechanical, and / or heat bonding) to the groove. In some embodiments, a positioning balloon and / or a membrane forming a positioning balloon may be added and / or attached to an exterior surface of the main body. In some embodiments, the mold may further include features configured to generate an inflation media conduit in the main body, wherein the inflation media conduit is configured to communicate with the cervical cuff balloon. In these embodiments, the mold may further include features configured to generate an inlet portion in communication with the inflation media conduit portion and the main body further comprises an inlet in communication with the inflation medica conduit that corresponds to the inlet portion and, at times, manufacturing the main body and / or a cervical control system including the main body may include inserting a first end of a tube into the inlet and a second end of the tube to a valve and / or valve housing that includes a valve configured to cooperate with a source of inflation media when inflating or deflating the cervical cuff balloon.

[0012] Methods of using a cervical control system to, for example, control a patient’s cervix, mitigate a pregnancy risk, restore amniotic fluid, treat short cervix, treat premature rupture of membranes (PROM) or preterm premature rupture of membranes (PPROM), and / or facilitate growth of a cervical mucus plug may include inserting a main body of a cervical control system (e.g., one of the bodies disclosed herein) into the patient’s vagina and positioning a patient’s cervix within an opening, or interior passageway of the main body and / or a cervical cuff balloon of the main body. The cervical cuff balloon may be inflated to engage, compress, and / or secure the cervix within the opening of the cervical cuff balloon, wherein inflation of the cervical cuff balloon exerts traction on the cervix to pull the cervix away from the uterus. Optionally, a positioning balloon of the main body may alsobe inflated to, for example, secure the main body within the vagina and / or adjust angle of orientation of (e.g., posteriorly tilt) of the cervix. The main body may be inserted into the vagina and / or seated around the cervix digitally and / or via the use of tools and, in most cases, may be implanted into the patient without the use of pain management medication and / or procedures (e.g., an epidural).

[0013] The cervical control system may further include a tube with a first end of the tube being in communication with an inflation media conduit of the main body that is also in communication with the cervical cuff balloon and / or the positioning balloon and a second end of the tube being in communication with a valve of a valve housing. The tube may be of sufficient length to allow access, outside the vagina, to the valve without changing a position of the cervical control system relative to the cervix so that the valve housing may be accessed by a clinician by extracting a portion of the tube from the patient’s vagina. Once the valve and / or valve housing is extracted from the vagina, a volume of inflation media within the cervical cuff balloon and / or the positioning balloon via cooperation of an inflation media source and the valve. In some embodiments, the valve housing may include a pressure sensing device and a volume of inflation media within at least one of the cervical cuff balloon and the positioning balloon may be adjusted responsively to a pressure reading from the pressure sensing device. In some embodiments, the cervical cuff balloon and / or positioning balloon may be temporarily deflated (partially or fully) so that a position of the cervix within the opening of the cervical cuff balloon may be adjusted and / or a position of the main body of the cervical control system may be adjusted and, once repositioned, the cervical cuff balloon and / or positioning balloon may be reinflated to secure the main body in its new position and the tube and / or valve may be placed back into the patient’s vagina. In some embodiments, adjustment of a position of the cervical control system and / or main body may be responsive to, for example, an indication of the cervical control system’s performance, a patient complaint, and / or part of a standard of care wherein the position is periodically adjusted to, for example, reduce a risk of tissue trauma within the vagina and / or around the cervix.BRIEF DESCRIPTION OF THE DRAWINGS

[0014] The following drawings are for illustrative (example) purposes only and show non-limiting embodiments. Features from different figures may be combined in several embodiments.

[0015] FIG. 1A provides a schematic diagram of a top view of an exemplary cervical control system, in accordance with some embodiments of the present invention;

[0016] FIG. 1 B provides a schematic diagram of a side view of an assembly of the cervical control system of FIG. 1A and a source of inflation media, in accordance with some embodiments of the present invention;

[0017] FIG. 1C provides a schematic diagram of a cross-section view of the assembly of FIG. 1 B, in accordance with some embodiments of the present invention;

[0018] FIG. 2A provides a schematic diagram of a side view of another exemplary cervical control system, in accordance with some embodiments of the present invention;

[0019] FIG. 2B provides a schematic diagram of a cross-section view of an assembly of the cervical control system of FIG. 2A and an inflation media source, in accordance with some embodiments of the present invention;

[0020] FIG. 2C provides a schematic diagram of a cross-section view of the assembly of FIG. 2B when a positioning balloon is in an expanded, or inflated, state, in accordance with some embodiments of the present invention;

[0021] FIG.3A illustrates a bottom perspective view of an exemplary main body of a cervical control system that includes an internal channel, in accordance with some embodiments of the present invention;

[0022] FIG.3B illustrates a cross section view of the main body of FIG.3A, in accordance with some embodiments of the present invention;

[0023] FIG. 3C provides a side perspective view of a cervical control system that includes the main body of FIG. 3A, in accordance with some embodiments of the present invention;

[0024] FIG. 3D provides a close up view of a portion of the cervical control system of FIG. 3A, in accordance with some embodiments of the present invention;

[0025] FIG. 3E provides a side view of an assembly that includes the cervical control system of FIG. 3A and an inflation media source, in accordance with some embodiments of the present invention;

[0026] FIG. 4A is a schematic diagram of a cross-section view of a portion of the main body of FIG. 1A, 2A, or 3A, in accordance with some embodiments of the present invention;

[0027] FIG. 4B1 is a schematic diagram of a top view of a main body of the cervical control system of FIG. 1A, 2A, or 3A that includes cut-away-section lines for FIG. 4B2 superimposed thereon, in accordance with some embodiments of the present invention;

[0028] FIG. 4B2 is a schematic diagram of a section view of the main body of FIG. 4B1 , in accordance with some embodiments of the present invention;

[0029] FIG. 4C illustrates a cross sectional view of a main body of a cervical control system with a cervix positioned within an inner passageway thereof when a cervical cuff balloon of the main body is in a neutral state, or unexpanded state, in accordance with some embodiments of the present invention;

[0030] FIG. 4D illustrates a cross sectional view of the main body of FIG. 4C with the cervix positioned within the inner passageway thereof and the cervical cuff balloon is in an inflated, expanded, and / or pressurized state, in accordance with some embodiments of the present invention;

[0031] FIG. 4E illustrates a cross sectional view of the main body of FIG. 4D with the cervix positioned within the inner passageway thereof and the cervical cuff balloon and a positioning balloon being in an inflated, expanded, and / or pressurized state, in accordance with some embodiments of the present invention;

[0032] FIG. 4F is a block diagram of a top view of a cervix positioned within the main body of FIG. 1A, 2A, or 3A when the cervical cuff balloon is inflated and the positioning balloon is not inflated, in accordance with some embodiments of the present invention;

[0033] FIG. 4G is a block diagram of a top view of the cervix of FIG. 4F positioned with the main body of FIG. 1 A, 2A, or 3A when the cervical cuff balloon and the positioning balloon are inflated, in accordance with some embodiments of the present invention;

[0034] FIG. 4H provides a block diagram of the main body of FIGs. 1A, 2A, or 3A with cervical cuff thereof in a first stage of inflation, in accordance with some embodiments of the present invention;

[0035] FIG. 41 provides a block diagram of the main body of FIG. 4H with cervical cuff thereof in a second stage of inflation, in accordance with some embodiments of the present invention;

[0036] FIG. 4J provides a block diagram of the main body of FIG. 4H with cervical cuff thereof in a third stage of inflation, in accordance with some embodiments of the present invention;

[0037] FIG. 5A illustrates a bottom view of a top mold, in accordance with some embodiments of the present invention;

[0038] FIG. 5B illustrates a bottom view of a waist mold, in accordance with some embodiments of the present invention;

[0039] FIG. 5C illustrates a top view of waist mold, in accordance with some embodiments of the present invention;

[0040] FIG. 5D illustrates a cross section view of top mold taken along bisecting line 5D of FIG 5A, in accordance with some embodiments of the present invention;

[0041] FIG. 5E illustrates a cross section view of waist mold taken along bisecting line 5E of FIG 5B, in accordance with some embodiments of the present invention;

[0042] FIG. 5F illustrates a top view of a bottom mold, in accordance with some embodiments of the present invention;

[0043] FIG. 5G illustrates a cross section view of bottom mold taken along bisecting line 5G of FIG 5F, in accordance with some embodiments of the present invention;

[0044] FIG. 5H is a bisecting cross section view of an assembly of the top mold of FIG. 5A, the waist mold of FIGS. 5B and 5C, and the bottom mold of FIG. 5F, in accordance with some embodiments of the present invention;

[0045] FIG. 6 is a flowchart illustrating an exemplary method for molding and manufacturing a main body of a cervical control system, in accordance with some embodiments of the present invention;

[0046] FIG. 7A Illustrates a perspective exploded view of the assembly of FIG. 5H with a molded cervical control system, in accordance with some embodiments of the present invention;

[0047] FIG. 7B is a cross section view of the exploded assembly and molded cervical control system of FIG. 7A, in accordance with some embodiments of the present invention;

[0048] FIG. 7C illustrates a bisecting cross sectional view of the cervical control system of FIG. 7A, in accordance with some embodiments of the present invention;

[0049] FIG. 7D illustrates an angled sectional view of the cervical control system of FIG. 7A, in accordance with some embodiments of the present invention;

[0050] FIG. 7E illustrates a bisecting cross sectional view of a cervical control system in which the cervical cuff balloon fully assembled, in accordance with some embodiments of the present invention;

[0051] FIG. 7F provides a side exploded view an assembled cervical control system, in accordance with some embodiments of the present invention; and

[0052] FIG. 8 illustrates a flow chart illustrating a process for using a cervical control system, the systems, and / or devices disclosed herein, in accordance with some embodiments of the present invention.WRITTEN DESCRIPTION

[0053] The cervical control systems disclosed herein may be used to, for example, treat short cervix, insufficient cervix, premature rupture of membranes (PROM), or preterm premature rupture of membranes (PPROM) by, for example, compressing and / or holding the cervix closed, elongating the cervix, and / or redirecting weight from the uterus away from the cervix by, for example, changing an angle of orientation of the cervix. The cervical control systems disclosed herein include a substantially ring-shaped main body with a central aperture, or interior passageway, sized and configured to accept insertion of a cervix therein. An inflatable cervical cuff balloon may be positioned around an exterior surface of a portion of the interior passageway so that it contacts, or otherwise engages, the cervix when inflated. Inflation of the cervical cuff may exert a compressive force on the cervical tissue that serves to, for example, hold the cervical control system in place within the vagina and / or around the cervix, hold the cervix closed so that, for example, amniotic fluid and / or a cervical mucus plug may be replenished, and / or exert traction on the cervix by pulling it away from the uterus and toward the interior of the central aperture. The cervical control system may also include an inflatable positioning balloon positioned on an exterior surface of a portion of the main body. When inflated, the positioning balloon may expand into the vagina to, for example, hold the cervical control system in place relative to the cervix and / or adjust an angleof orientation of the cervix to, for example, redirect weight from the uterus away from cervical tissue.

[0054] The cervical cuff balloons disclosed herein may comprise a flexible membrane of uniform or varying width that define one or more inner chambers open to and / or configured for acceptance of inflation media therein. As inflation media is inserted and / or pushed into the inner chamber of the cervical cuff balloon, the corresponding flexible membrane may responsively expand in size to, for example, engage and / or constrict a cervix positioned therein . The expansion of the cervical cuff balloons may be in radial and / or downward (i.e., away from the uterus) directions. In several embodiments, the cervical cuff balloons disclosed herein are shaped and dimensioned with recessed portions configured to permit blood flow from the upper cervix to the lower cervix protruding through the cervical cuff balloon.

[0055] The cervical control systems disclosed herein may be made from any appropriate material including but not limited to silicone and / or plastic and, on some occasions, a main body of the cervical control systems disclosed herein may be one-piece and / or molded in one piece with a positioning balloon, tube, and optional valve housing including one or more valves to complete the cervical control system.

[0056] Turning now to the drawings, FIG. 1 A provides a schematic diagram of a top view of an exemplary cervical control system 100 that includes a main body 110 with a top (as oriented in FIGs. 1 B and 1 C) side 116 and a bottom (as oriented in FIGs. 1 B and 1C) side 118, a tube 140, and a valve housing 142. FIG. 1 B provides a schematic diagram of a side view of an assembly 101 of exemplary cervical control system 100 and a source of inflation media 180. FIG. 1C provides a schematic diagram of a cross-section view of assembly 101 taken along phantom bisecting line 1C-1C of FIG. 1A.

[0057] Main body 110 is a substantially ring-shaped main body sized and configured to fit within a patient’s vagina proximate to the cervix that includes an exterior surface 112 and an interior surface 115. Inner surface 115 defines and / or establishes an interior passageway 114 that extends from a top side 116 opening to a bottom side 118 opening of main body 110. A positioning balloon 130 may be positioned on a portion of exterior surface 312 and may be of any appropriate shape and / or size. In some embodiments, positioning balloon 130 and may extend around, for example, a full, or partial (e.g., 20-95%, 40-80%, 40-70%, 50%, 60%,70%, 80%, and any range therebetween) circumference of exterior surface 112. Positioning balloon 130 may be configured to extend across a portion (e.g., 10- 100%, 15-95%, 40-85%, 40-75%, 40%, 50%, 60%, 70%, 75%, 80% or 90%) of a height (i.e., the dimension between top 116 and bottom sides 118). In some embodiments, a bottom edge of positioning balloon 130 may approximately align with a bottom edge of main body 110 and / or a top edge of positioning balloon 130 may align with an approximate position of cervical cuff balloon 120. In the embodiment of FIGs. 1A-1C, positioning balloon 130 has an approximately rectangular shape with a length (i.e., around the circumference of main body 110) that is greater than a width (i.e., a distance between the top and bottom sides of positioning balloon) but this need not aways be the case. In some cases, positioning balloon 130 may have an ovoid, trapezoidal, hexagonal, or irregular shape.

[0058] Cervical cuff balloon 120 includes two expandable portions 122 positioned approximately 180 degrees apart from one another around top opening 116. Expandable portions 122 include a plurality (in this case, five per expandable portion 122) of projections, or cleats, 126 thereon that extend from an exterior surface of expandable portions into interior passageway 114 as shown. Cleats 125 may be configured and / or arranged to engage cervical tissue when cervical cuff balloon 120 is inflated to, for example, prevent slippage of cervical control system 100 from its intended position around the cervix. Cervical cuff balloon 120 also includes two recessed portions 124 positioned between expandable portions 122. Recessed portions 224 may be configured to remain relatively static (i.e., not expand) when expandable portions 122 expand to engage the cervix so that compressive force is not uniformly applied to the circumference of the cervix. The lack of compressive force exerted on portions of the cervix underlying recessed portions 124 may allow for the flow of blood within the cervical tissue and / or prevent ischemia of portions of the cervix positioned below cervical support system 100.

[0059] Cervical cuff balloon 120 may be a flexible membrane with a cervical cuff inner chamber 150 positioned therein (see FIG. 1C) and positioning balloon 130 may be a flexible membrane with a balloon inner chamber 132 positioned therein (see FIG. 1C). Cervical cuff inner chamber 150 and balloon inner chamber 132 may be in fluid communication with an inflation media conduit 138 that extends from an inlet 139 positioned on a bottom side of main body 110 to a cross channel134 within main body 110. Cervical control system 100 also includes a cervical cuff balloon inflation media conduit 138 that extends from, and is in fluid communication with, inflation media conduit 138. During inflation, inflation media may be pushed into inflation media conduit 138 via inlet 139. From there, the inflation media may be pushed into cervical cuff balloon inflation media conduit 138 for collection in cervical cuff inner chamber 150 and cross channel 134 for collection within positioning balloon inner chamber 132 so that cervical cuff inner chamber 150 and positioning balloon inner chamber 132 fill with inflation media and the flexible membrane of cervical cuff balloon 120 and positioning ballon 130 expand to accommodate positioning of inflation media therein. For embodiments where cervical cuff inner chamber 150 and positioning balloon inner chamber 132 have the same or a similar overall volume, cervical cuff balloon 120 and positioning balloon 130 may expand an approximately the same rate as inflation media is added to inflation media conduit 138. For embodiments where cervical cuff inner chamber 150 has a smaller volume than positioning balloon inner chamber 132, cervical cuff balloon 120 may expand more quickly than positioning balloon 130. For embodiments where cervical cuff inner chamber 150 has a larger volume than positioning balloon inner chamber 132, cervical cuff balloon 120 may expand slower than positioning balloon 130.

[0060] Optionally, cervical support system 100 further includes a choke point 136 positioned within cross channel 134. Choke point 136 may be configured and positioned to slow a flowrate of inflation media entering positioning balloon inner chamber 132so that inflation media flows faster through inflation media conduit 138 to cervical cuff inner chamber 150 than positioning balloon inner chamber 132, thereby inflating cervical cuff balloon 120 before, or more rapidly than, positioning balloon 130. Thus, choke point 136 may allow for the expansion of cervical cuff balloon 120 around a cervix positioned within inner passageway 114 and / or top opening 116 as, for example, shown and described herein before positioning balloon 130 is inflated. This may allow a clinician to secure cervical support system 100 to a patient’s cervix (via expansion of cervical cuff balloon 120) prior to repositioning (e.g., adjusting an angle) of cervix or otherwise mounting cervical control system 100 within a patient’s vagina and / or inflating positioning balloon 130 to hold cervical control system 100 in place.

[0061] Cervical control system 100 also includes a tube 140, a first end of which may be positioned in line with and / or coupled to inlet 139 so that tube 140 may be in fluid communication with inflation media conduit 138. A second end of tube 140 may be aligned with a first side of single port valve housing 142 and a valve 146 contained therein. As may be seen in the cross section of FIG. 1C, single port valve housing 142 may include a channel 148 configured for cooperation with a lumen of tube 140 and a needle 186 of source of inflation media 180. Valve 146 may be, for example, a one-way valve, a duckbill valve, a silicone valve, a baffle, a check valve, a Halkey Roberts valve, a luer-activated check valve, and / or a check valve. As shown in FIGs. 1A-1C, a lid 144 of single port valve housing 142 is open, thereby allowing access to valve 146. However, when valve 146 is not in use, lid 144 may be closed and / or moved to cover valve 146 to, for example, protect it from damage and / or contamination.

[0062] In FIGs. 1 B and 1C, source of inflation media 120 is embodied as a syringe with a barrel 182 configured to hold a volume of inflation media, a needle 186 configured to communicate inflation media into and / or out of barrel 182, and a plunger 184 positioned within barrel 182 and configured to articulate therein to, for example, push inflation media through needle 186 and into valve 146 to, for example, inflate cervical cuff balloon 120 and / or positioning balloon 130 and / or pull inflation media into barrel 122 valve to, for example, deflate cervical cuff balloon 120 and / or positioning balloon 130 to allow for repositioning (e.g., rotating and / or moving proximally and / or distally along the cervix) and / or removal of cervical control system 100 from the patient’s vagina.

[0063] FIG. 2A provides a schematic diagram of a side view of an exemplary cervical control system 200 that includes a main body 210 with a top side 216 and a bottom side 218, a valve housing 242, an interior passageway 214, a bi-lumen tube 240 physically and communicatively coupled to components of main body 210, and valve housing 242. FIG. 2B provides a schematic diagram of a crosssection view of an assembly 201 of exemplary cervical control system 200 and inflation media source 180 when a positioning balloon 230 of main body 210 is in a neutral, or deflated, state. FIG. 2C provides a schematic diagram of a crosssection view of assembly 201 when positioning balloon 230 is in an expanded, or inflated, state.

[0064] Main body 210 is substantially ring-shaped and includes an exterior surface 212 and an interior surface 215. Inner surface 215 defines and / or establishes a portion of dimensions for an interior passageway 214 that extends from a top (as oriented in FIGs. 2B and 2C) side 216 opening to a bottom (as oriented in FIGs. 2B and 2C) side 218 opening of main body 210. Like positioning balloon 130, positioning balloon 230 is positioned on, and covers, a portion of exterior surface 212 and may extend around, for example, a full, or partial (e.g., 20-95%, 40-80%, 40-70%, 50%, 60%, 70%, 80%, and any range therebetween) circumference of exterior surface 212. Positioning balloon 230 may be configured to extend across a portion (e.g., 10-100%, 15-95%, 40-85%, 40-75%, 40%, 50%, 60%, 70%, 75%, 80% or 90%) of a height (i.e., the dimension between top 216 and bottom sides 218). In some embodiments, a bottom edge of positioning balloon 230 may approximately align with a bottom edge of main body 210 and / or a top edge of positioning balloon 230 may align with an approximate position of a lower portion of cervical cuff balloon 220. In the embodiment of FIGs. 2A-2C, positioning balloon 230 has an approximately rectangular shape with a length (i.e., around the circumference of main body 210) that is greater than a width (i.e., a distance between the top and bottom sides of positioning balloon) but this need not aways be the case. In some cases, positioning balloon 230 may have an ovoid, trapezoidal, hexagonal, or irregular shape.

[0065] Cervical cuff balloon 220 surrounds a top 216 (or top as oriented in FIGs. 2A-2C) portion of interior surface 215 and provides a top opening 217 that opens to interior passageway 214. Cervical cuff balloon 220 includes two expandable portions 222 positioned approximately 180 degrees apart from one another around a circumference of top opening 216. Expandable portions 222 include a plurality of projections, or cleats, 226 positioned thereon that extend from an exterior surface of expandable portions 222 into interior passageway 214 as shown. Cleats 225 may be configured and / or arranged to engage cervical tissue when cervical cuff balloon 220 is inflated to, for example, prevent slippage of cervical control system 200 from its intended position around the cervix. Like cervical cuff balloon 120, cervical cuff balloon 220 also includes two recessed portions 224 positioned between expandable portions 222.

[0066] Cervical cuff balloon 220 may be a flexible membrane with a cervical cuff inner chamber 250 (see FIG. 2B) positioned therein and positioning balloon 230may be a flexible membrane with a positioning balloon inner chamber 232 positioned therein (see FIGs. 2B and 2C). Cervical cuff inner chamber 250 may be in fluid communication with a first inflation media conduit 236 and balloon inner chamber 232 may be in fluid communication with a second inflation media conduit 234. Main body 210 may include a first inlet (not shown) in fluid communication with cervical cuff inner chamber 250 and a second inlet 239 in fluid communication with positioning balloon inner chamber 232 and first end of bi-lumen tube 240 may be physically coupled to main body 210 via the first inlet and second inlet 239 so that a first lumen of bi-lumen tube 240 is in communication with first inflation media conduit 236 and second lumen of bi-lumen tube 210 is in communication with second inflation media conduit 234. First and second portions of bi-lumen tube (which provide the sidewalls for first and second lumens, respectively) 240 may be attached to first and second inlet 239 via an appropriate means including, but not limited to, chemical, mechanical, and / or thermal bonding.

[0067] In some embodiments, bi-lumen tube 240 may have a length (e.g., 3-16 inches) sufficient, when in situ, to extend away from main body 210 (when placed in the patient’s vagina) and out through the vaginal opening such that a care provider may easily access valve system 242 without removing or repositioning main body 210 within the patient. A second, bottom, end of bi-lumen tube 240 may be coupled to a valve housing 242, that includes a first valve 246A, a second valve 246B, and a cover, or cap, 244 that may be connected to valve housing 242 by a tether 243 or other connector (e.g., a hinge). Cap 244 can be removably coupled to the bottom end of the valve housing 242 and may be configured and / or arranged to cover first and / or second valves 246A and 246B when closed (e.g., engaged with a bottom end of valve housing 242) and configured to allow access to first and second valves 246A and 246B when open (e.g., disengaged from the bottom end of valve housing 242). In some embodiments, valve housing 242 may not include cap 244.

[0068] Bi-lumen tube 240 may be coupled to valve housing 242 so that the first lumen of bi-lumen tube 240 is in fluid communication with first valve 246A and the second lumen of bi-lumen tube 240 is in fluid communication with second valve 246B.

[0069] Valve system 242 may be similar in form and / or function to valve system 142 except that it holds two valves instead of one. In some cases, first and secondvalves 246A and 246B may be the same and in other embodiments, they may be different. Exemplary first and / or second valves 246A and 246B include, but are not limited to, one-way valves, duckbill valves, silicone valves, check valves, Halkey Roberts valves, luer activated check valves, check valves with polycarbonate bodies and / or combinations thereof. Use of a polycarbonate main body for first and / or second valve(s) 246A and 246B may reduce and / or eliminate a risk that the valve can be unintentionally manipulated to break the seal and lose pressure. In some embodiments, valve housing 242 may not include valves and, instead may include a first or second port that allows direct fluid communication with first and / or second lumen, respectively.

[0070] Cervical cuff balloon 220 and / or positioning balloon 230 may be inflated using one or more sources of inflation media 180. In FIGs. 2B and 2C, source of inflation media 180 is embodied as syringe with barrel 182 configured to hold a volume of inflation media 262, needle 186 configured to communicate a portion of volume inflation media 262 into and / or out of barrel 182, and a plunger 184 positioned within barrel 182 and configured to articulate therein to, for example, push a portion of volume inflation media 262 through needle 186 and into first valve 246A so that it may be communicated to the first lumen of bi-lumen tube 240, first inflation media conduit 236, and cervical cuff inner chamber 250 so that the membrane of cervical cuff balloon 220 may expand and cervical cuff balloon 220 may inflate. Additionally, or alternatively, source of inflation media 180 may be configured to push a portion of inflation media 262 through needle 186 and into second valve 246B so that it may be communicated to the second lumen of bilumen tube 240, second inflation media conduit 234, and positioning balloon chamber 250 so that the membrane of positioning balloon 220 may expand and positioning balloon 230 may inflate. The reverse process may be performed for the first and / or second valve 246A and / or 246B to deflate cervical cuff balloon 220 and / or positioning balloon 230, respectively. In some embodiments, cervical cuff balloon 220 and / or positioning balloon 230 may be deflated to allow for repositioning (e.g., rotating and / or moving proximally and / or distally along the cervix) and / or removal of cervical control system 200 from the patient’s vagina.

[0071] Because first and second valve s246A and 246B are independently operable, a clinician may tune a degree of inflation of cervical cuff balloon 220 and / or positioning balloon 230 as needed to, for example, increase patient comfort,increase compressive force exerted upon the patient’s cervix, adjust an orientation of the cervix, and / or improve stabilization of cervical control system 200 within the vagina and / or around the cervix. Independent operation of first and second valve s246A and 246B also allows a clinician to fit a woman with cervical support system 200 by inserting cervical control system 200 into the patient’s vagina and positioning the patient’s cervix within interior passageway (via expansion of cervical cuff balloon 220) prior to repositioning (e.g., adjusting an angle) of cervix or otherwise mounting cervical control system 200 within a patient’s vagina and / or inflating positioning balloon 230 to hold cervical control system 200 in place and / or tailor a fit of cervical control system to a patient’s anatomy by separately controlling a degree of inflation of cervical cuff balloon 220 and / or positioning balloon 230.

[0072] Since main body 210 is positioned within the vagina during use, it may be difficult to assess (e.g., visually, or otherwise, observe) how much pressure is being applied to patient tissue by cervical cuff balloon 222 and / or positioning balloon 230. To assist with this assessment, valve housing 242 may optionally include and / or be physically and / or communicatively coupled to one or more sensors 290 configured to, for example, directly and / or indirectly measure and / or monitor one or more aspects of the operation of system 200 including, but not limited to, an amount of backpressure exerted by inflation media present in first and / or second conduits 246 and / or 248, a flowrate of inflation media entering and / or exiting first and / or second conduits 246 and / or 248, a volume of inflation media entering and / or exiting first and / or second conduits 246 and / or 248 and / or changes thereof.

[0073] In some embodiments, sensor 290 may be and / or include a tactile or visual pressure gauge with a display provided on valve housing 242. For example, valve housing 242 may include a first pressure gauge 290A positioned in-line between the first valve 246A and first inflation media conduit 246 and a second pressure gauge 290B positioned in-line (via a lumen 286) between second valve 246B and second inflation media conduit 248 to measure, or provide an indication of, inflation media pressure within respective first and second inflation media conduits 246 and 248 and / or cervical cuff balloon 220 and / or positioning balloon 230, respectively. For example, first and / or second pressure gauges 290A and 290B may comprise a tactile pressure gauge (e.g., a pressure balloon), configured to expand and / or contract responsively to a degree of pressure exerted by inflationmedia within first and / or second lumens and / or first and / or second inflation media conduit(s) 236 and / or 234, respectively. For example, in FIG. 2B, second pressure gauge 290B is flat or not expanded, which corresponds to the neutral, or deflated, state of positioning balloon 230 shown in FIG. 2B. Then, when a volume and pressure of inflation media within positioning ballon inner chamber 232 increases, positioning balloon 230 and second pressure gauge 290B may expand, or inflate, as shown in FIG. 2C. Additionally, or alternatively, in some embodiments, first and / or second pressure gauge 290A and / or 290B may include a visual color indicator or other feedback mechanism.

[0074] FIG.3A provides a bottom perspective view and FIG.3B provides a cross section view of an exemplary main body 310 of a cervical control system 300 (also referred to herein as “system 300”). FIG. 3C provides a side perspective view of cervical control system 300, FIG. 3D provides a close up view of a portion of cervical control system 300, and FIG. 3E provides a side view of an assembly 301 that includes cervical control system 300 and inflation media source 180.

[0075] System 300 includes a main body 310 with a top (as oriented in FIG. 3B) side 316 and a bottom (as oriented in FIG. 3B) side 318, a tri-lumen tube 340, a valve housing 342, first inflation media conduit 236, and second inflation media conduit 234, with first and second inflation media conduits 236 and 234 being positioned in main body 310 as shown in FIGs. 2B and 2C. Main body 310 is a substantially ring-shaped main body sized and configured to fit within a patient’s vagina proximate to the cervix that includes an exterior surface 312 and an interior surface 315. Inner surface 315 defines and / or establishes an interior passageway 314 that extends from a top side 316 opening to a bottom side 318 opening of main body 310. A positioning balloon 330 may be positioned on a portion of exterior surface 312 and may be of any appropriate shape and / or size. In some embodiments, positioning balloon 330 may extend around, for example, a full, or partial (e.g., 20-95%, 40-80%, 40-70%, 50%, 60%, 70%, 80%, and any range therebetween) circumference of exterior surface 312. Positioning balloon 330 may be configured to extend across a portion (e.g., 30-100%, 35-95%, 40-85%, 40- 75%, 40%, 50%, 60%, 70%, 75%, 80% or 90%) of a height (i.e., the dimension between top 316 and bottom sides 318). In some embodiments, a bottom edge of positioning balloon 330 may approximately align with a bottom edge of main body 310 and / or a top edge of positioning balloon 330 may align with an approximateposition of cervical cuff balloon 320. In the embodiment of FIGs. 3A-3E, positioning balloon 330 has an approximately rectangular shape with a length (i.e., around the circumference of main body 310) that is greater than a width (i.e., a distance between the top and bottom sides of positioning balloon) but this need not aways be the case. In some cases, positioning balloon 330 may have an ovoid, trapezoidal, hexagonal, or irregular shape. In some embodiments, positioning balloon 330 may include flexible membrane that is attached to main body 310 via coupling channels 337 (see FIG. 3B).

[0076] Cervical control system 300 includes a cervical cuff balloon 320 similar to cervical cuff balloon 220 and 110 as well as an internal channel 360 positioned on a portion of interior surface 315 that encircles a portion of inner passageway 314. Internal channel 360 includes a plurality of openings, or ports, 362 that may be uniformly, or non-uniformly, spaced around the top interior of system 300. Each port 362 may be configured to allow for fluid (e.g., medication, antibacterial agents, wash fluid, etc.) to exit internal channel 360 so that it may flow onto interior surface 315 and / or a cervix positioned within interior passageway 315 and / or cervical cuff 320, for example, as shown and described herein.

[0077] As may be seen in FIG. 3A, system 300 includes a first port 324, a second port 364, and a third port 339. First port 324 is in communication with cervical cuff balloon 320 via a first inflation media conduit (not shown) that is similar to first inflation media conduit 236. Second port 364 is in communication with positioning balloon 330 via a second inflation media conduit (not shown) that is similar to second inflation media conduit 234. Third port 339 is in communication with internal channel 360 via a conduit 366 (see FIG. 3B). As may be seen in FIG. 3D, first port 324 is in communication with a first section (that includes a first lumen) 342 of trilumen tube 340; second port 364 is in communication with a second section (that includes a second lumen) 344 of tri-lumen tube 340; and third port 339 is in communication with a third section (that includes a third lumen) 346 of tri-lumen tube 340.

[0078] A second end of tri-lumen tube 340 and / or first, second, and / or third sections 342, 344, and / or 346 may be physically coupled to with a first side of a valve housing 342 and each lumen of tri-lumen tube 340 may be in communication with one or more valves 346 (e.g., a one-way valve, a duckbill valve, a silicone valve, a baffle, a check valve, a Halkey Roberts valve, a luer-activated check valve,and / or a check valve) of valve housing. For example, first section 342 may be physically coupled to and / or in communication with a first valve 346A, second section 344 may be physically coupled to and / or in communication with a second valve 346B, and third section 346 may be physically coupled to and / or in communication with a third valve 346C. Inflation media may be added to and / or extracted from cervical cuff inner chamber 350 and / or positioning balloon 330 by inserting a portion (e.g., a needle) of an inflation media source into first or second valve 346A or 346B, respectively and pushing inflation media into first section 342 or second section 344 of tri-lumen tube for communication to cervical cuff inner chamber 350 or an inner chamber of positioning balloon 300, respectively and / or extracting inflation media therefrom as, for example, described herein with regard to cervical control system 200.

[0079] During use, a medical substance (e.g., saline, medication, water, lubricant, hormones, analgesic, etc.) may be introduced to system 300 via insertion of a medical substance source (e.g., a syringe like syringe 180) into third valve 346C and communication of the medication substance from the medical substance source to third portion 346 of tri-lumen tube for communication to internal channel 360. Once in internal channel 360, the medical substance may exit (e.g., pour out, leach out, etc.) one or more ports 362 and contact cervical tissue proximate thereto to, for example, clean and / or medicate the cervical tissue. Additionally, or alternatively, negative pressure and / or a vacuum may be communicated to internal channel 360 and ports 362 via application to a source of negative pressure (e.g., a vacuum pump or syringe by extraction of a plunger from the syringe’s barrel) to third valve 346C. The negative pressure and / or vacuum may evacuate substances (e.g., blood, vaginal discharge, bacteria, rinsing saline, etc.) away from the cervix and / or act to engage or hold the cervix in place by, for example, removing fluid and other material from the cervix.

[0080] As shown in FIGs. 3C, a lid 344 of valve housing 342 is open, thereby allowing access to first, second, and third valve 346A, 346B, and 346C. However, when valve 346 is not in use (e.g., when tri-lumen tube and valve housing 342 are positioned within the vagina), a lid 344 may be closed and / or moved to cover first, second, and / or third valve(s) 346A, 346B, and / or 346C to, for example, protect it from damage and / or contamination.

[0081] In some embodiments, cervical cuff inner chamber 150, 250, and / or 350 may be a single chamber that resides within cervical cuff balloon 120, 220, and / or 320 but has different dimensions for the expandable portions and recessed portions thereof, wherein dimensions for cervical cuff inner chamber 150, 250, and / or 350 are larger for portions of cervical cuff inner chamber 150, 250, and / or 350 corresponding to expandable portions 122, 222, and / or 322 than portions of cervical cuff inner chamber 150, 250, and / or 350 corresponding to recessed portions 124, 224, or 324. Thus, portions of cervical cuff inner chamber 150, 250, and / or 350 corresponding to expandable portions 122, 222, or 322 and recessed portions 124, 224, or 324 are in communication with one another to, for example, allow for a flow of inflation media between them. This allows for all regions of cervical cuff inner chamber 120, 220 and / or 320 to be filled with inflation media and / or allows both expandable portions 122, 222, and / or 322 of a cervical cuff balloon 120, 220, and / or 320 to, for example, hold the same, or similar volumes of inflation media and / or balance pressure exerted by inflation media around cervical balloon 120, 220, and / or 320 so that, for example, compressive force is uniformly, or nearly uniformly, exerted by both expandable portions 122, 222, or 322 of a main body 110, 210, or 310, respectively, around the cervix. Sidewalls of recessed portions 124, 224, and / or 324 may be thicker than sidewalls of expandable portions 122, 223, and / or 323, respectively, and therefore resistant to expansion when cervical cuff balloon 110, 210, and / or 310 is pressurized with inflation media so that their recessed shape relative to expandable portions is maintained even when cervical cuff balloon 110, 210, and / or 310 is inflated and / or pressurized. Thus, recessed portions 124, 224, and / or 324 may expand less than expandable portions recessed portions 122, 222, and / or 322 when inflation media is added to cervical cuff inner chamber 150, 250, or 350.

[0082] FIG. 4A is a schematic diagram of a cross-section view of a portion of a main body 110, 210, or 310 that shows an exemplary cross-sectional shape of chamber 150, 250, or 350 of expandable portions 122, 222, or 322 of cervical cuff balloon 110, 210, or 310, respectively, that includes s a first arc 410 with a length of approximately 5.4-8mm, 6mm, or 6.6mm and a second arc 420 that has a length of, for example, 5.3-3.5mm, 5.1 -4.6mm, or 4.8mm. First arc 410 is longer than second arc 420 and this configuration allows for expansion of cervical cuff balloon 110, 210, or 310 toward interior passageway 114, 214, or 314 as well as adownward direction (as oriented in the figure) toward bottom side 118, 218, or 318, respectively as shown in FIG. 4D. Stated differently, because first arc 410 is longer than second arc 420, a portion of cervical cuff balloon 110, 210, or 310 corresponding to first arc 410 is configured to expand more than a portion of cervical cuff balloon 110, 210, or 310 corresponding to second arc 420 and this difference in the expansion of the portion of cervical cuff balloon 110, 210, or 310 corresponding to first arc 410 acts to cervical cuff balloon 110, 210, or 310 corresponding to first arc 410 toward bottom side 118, 218, or 318 as it expands.

[0083] FIG. 4B1 is a schematic diagram of a top view of a main body 110, 210, or 310 that includes vertical and horizontal cut-away-section lines for FIG. 4B2 superimposed thereon and FIG. 4B is a schematic diagram of a section view of main body 110, 210, or 310 taken along the cut-away-section lines of FIG. 4B1 showing approximately % of main body 110, 210, or 310. FIG. 4B2 shows relative dimensions for a portion of cervical cuff inner chamber 150, 250, or 350 corresponding to, or resident within, expandable portions 122, 222, or 322, respectively and a portion of cervical cuff inner chamber 150, 250, or 530 corresponding to, or resident within, recessed portions 124, 224, or 324, respectively. Dimensions for the portion of cervical cuff inner chamber 150, 250, or 530 corresponding to, or resident within, respective recessed portions 124, 224, or 324 may be smaller than and / or configured to accommodate and / or hold a smaller volume of inflation media than the portion of cervical cuff inner chamber 150, 250, or 350 corresponding to, or resident within, respective expandable portions 122, 222, or 322. In addition, a sidewall of recessed portions 124, 224, or 324 may be thicker than a sidewall of expandable portions 122, 222, or 322. For example, a thickness of a sidewall of expandable portions 122, 222, or 322 may be 0.02-0.095 inches, 0.02-0.06 inches, 0.03-0.045 inches, or 0.04 inches and a thickness of a sidewall of recessed portions 124, 224, or 324 may be 0.03-0. Winches, 0.05-0.15 inches, 0.08-0.15 inches, or 0.1 inches.

[0084] Both the smaller size and thicker sidewalls of the portion of cervical cuff inner chamber 150, 250, or 350 corresponding to, or resident within, respective recessed portions 124, 224, or 324 contribute to less expansion of recessed portions 124, 224, or 324 when cervical cuff inner chamber 150, 250, or 350 is filled with, or pressurized by, inflation media. Stated differently, the portion of cervical cuff inner chamber 150, 250, or 350 corresponding to, or resident within,respective recessed portions 124, 224, or 324 is configured to hold a smaller volume of inflation media than the portion of cervical cuff inner chamber 150, 250, or 350 corresponding to, or resident within, respective expandable portions 122, 222, or 322. In addition, recessed portions 124, 224, and 324 are configured to expand less than expandable portions 122, 222, and 322, or not expand at all, in response to inflation and / or pressurization by inflation media resident within cervical cuff inner chamber 150, 250, or 350 by, for example having thicker (e.g., 10-1000%, 10-400%, 50-500%, 50-250%, 100%, 200%, 300%, 400%, thicker and all values and ranges in between) sidewall than a sidewall of expandable portions 122, 222, and 322.

[0085] FIG. 4C is a sectional view of main body 110, 210, or 310 when cervical cuff balloon 120, 220, or 320 is in a neutral, or uninflated, state, positioning balloon 130, 230, or 330 in a neutral, or uninflated, state, and a cervix 410 is positioned within an interior passageway of main body 110, 210, or 310 with a portion of cervix 410 proximate to the internal cervical os being encircled by cervical cuff balloon 120, 220, or 320 and a remainer of the cervix being positioned in interior passageway 114, 214, or 314 but not necessarily touching internal surface 115, 215, or 316 of internal passageway 114, 214, or 314. FIG. 4C also includes a first phantom line 401 aligned with a top (as oriented in the figure) of cervical cuff balloon 120, 220, or 330 when in a neutral, uninflated, state, a second phantom line 402 aligned with a bottom (as oriented in the figure) of cervical cuff balloon 120, 220, or 330 when in a neutral, uninflated, state, and a phantom line representing a first, unadjusted, and / or original, uterocervical angle 480A for the patient’s cervix as shown in FIG. 4C. A uterocervical angle may be defined as the angle formed between the cervical canal and the lower uterine segment. This angle has an impact on pregnancy outcomes because the uterocervical angle of approximately 180 degrees may causes the gravity of both the uterus and the fetus to be acting in line with the cervix, which puts pressure on the cervix and / or causes it to shorten. In addition, a uterocervical angle of approximately 180 degrees can cause a first, or original, lower uterine segment 470 angle ai to have an acute angular shape as seen in FIG. 4D, which directs force onto cervix 410, which may cause it to shorten and / or dilate.

[0086] Once cervix 410 is positioned within interior passageway 114, 214, or 314 as shown in FIG. 4C, cervical cuff balloon 120, 220, or 320 may be inflated via, for example, inflation media pushed into cervical cuff inner chamber 150, 250, or 350 via inflation media conduit such as inflation media conduit 138 or first inflation media conduit 236, in a manner similar to that described herein. During inflation, cervical cuff balloon 120, 220, or 320 directionally expands toward inner passageway and downward (as oriented in the sectional view of FIG. 4D) past second phantom line 402 so that cleats 126, 226, or 336 press into an exterior surface of cervix 410 to press the cervical tissue closed with, for example, circumferential compressive force, and push it downward further into interior passageway, thereby elongating cervix 410 as shown in FIG. 4D.

[0087] The inward and downward expansion of cervical cuff balloon 120, 220, and 320 is facilitated and enabled by the length of first arc 410 being larger than the length of second arc 420 so that a portion of cervical cuff balloon 120, 220, and 320 corresponding to first arc 410 has more room to expand than a portion of cervical cuff balloon 120, 220, and 320 corresponding to second arc 420. Additionally, or alternatively, the directional expansion of cervical cuff balloon 120, 220, or 320 may be enabled by varying wall thicknesses of material comprising cervical cuff balloon 120, 220, or 320. When in a neutral state, cervical cuff chamber 150, 250, or 350 is bound, or defined, by an inner wall 1521 that has a shape approximating an elongated semi-circle. An exterior surface of cervical cuff balloon 120, 220, or 320 is defined by an outer wall 1523 that has cleats 1526 molded therein. When in a neutral state (e.g., FIG. 4C), a space between inner and outer walls 1521 and 1523 may be relatively thin on the top and bottom and wider at an apical portion of the curve of cervical cuff balloon 120, 220, or 320 so that a material comprising cervical cuff balloon 120, 220, or 320 may be thicker proximate to the apical portion (i.e., toward the apex of the approximately semi-circular curve of cervical cuff balloon 120, 220, or 320) than at the top and bottom. As cervical cuff balloon 120, 220, or 320 is pressurized by the introduction of inflation media into chamber 150, 250, or 350, the respective the apical portion stretches, or becomes thinner (e.g., 10-95% thinner), thereby expanding chamber 150, 250, or 350 to accommodate pressurization caused by the introduction of the inflation media into chamber 150, 250, or 350 in a preferred direction as shown in FIG. 4D. Expansion (e.g., radial inward expansion and / or downward expansion) of cervicalcuff balloon 120, 220, or 320 acts to, for example, press cleats 126, 226, or 336 into cervical tissue, thereby increasing engagement between cleats 126, 226, or 336 and cervical tissue. Additionally, or alternatively, expansion (e.g., radial inward expansion and / or downward expansion) of cervical cuff balloon 120, 220, or 320 may act to engage cervix 410, compress it closed, and / or pull it downward (relative to first and second phantom lines 401 and 402 and away from the uterus), thereby transitioning cervix 410 from its original state (see. e.g., FIG. 4C) to a compressed and / or elongated state as shown in FIG. 4D, which may be helpful with, for example, preventing preterm birth, cervical dilation, and / or treating PROM and / or PPROM. Stated differently, the tension, elongation, and / or compression of cervix 410 via inflation of cervical cuff balloon 120, 220, or 320 may create an anatomical state of cervix 410 that may control cervical function (e.g., prevent dilation and / or shorting) and, in some cases, may provide conditions conducive to replacement, enlargement, and / or regeneration of a cervical mucus plug (not shown) positioned at, or near, an internal os of cervix 410 and / or regeneration of amniotic fluid by preventing leaking of the amniotic fluid from an opening in the cervix.

[0088] FIG. 4E is a sectional view of main body 110, 210, or 310 when with cervix positioned within the inner passageway thereof and cervical cuff balloon 120, 220, or 320 and positioning balloon 130, 230, or 330 are in an inflated, expanded, and / or pressurized state. As positioning balloon 130, 230, or 330 expands, it contacts a vaginal wall 490 and exerts a force F1 thereon. F1 is opposed by a force F2 exerted on the cervical tissue being compressed by inflated cervical cuff balloon 120, 220, or 320, which acts to tilt the cervix by an angle 0 and change first uterocervical angle 480A to a second uterocervical angle 480B, which reduces the force of the uterus and fetus on the cervix so that the cervix is better able to support the fetus, remain closed, and extend gestation time for the fetus. A change 0 between first and second uterocervical angle 480A and 480B may be between, for example, 0.5- 30 degrees, 0.5-25 degrees 10-20 degrees, 15-25 degrees, 20 degrees, 15 degrees, 17 degrees, 28 degrees, 5 degrees, or 8 degrees. In addition, changing the first uterocervical angle 480A to the second uterocervical angle 480B may act to flatten first lower uterine segment 470 angle ai, or transition to a second lower uterine segment 470 angle a2 that is less acute / more obtuse, thereby changing the dimensions for lower uterine segment 470 in a manner that disperses the weightof the uterus and / or a fetus therein across a broader area of the uterus and the patient’s anatomy and not just directly onto the cervix as shown in FIG. 4E.

[0089] FIG. 4F is a block diagram of a top view of a cervix 410 positioned with the cervical control system of FIG. 1A, 2A, or 3A when cervical cuff balloon 110, 210, or 310 inflated and the positioning balloon 130, 230, or 330 is not inflated as may be the case with FIG. 4D. In FIG. 4F, a cervical neck 410A (i.e., portion of the cervix proximate to the uterus) is surrounded by, held in place, and compressed by cervical cuff balloon 110, 210, or 310 while a remaining portion 410B of cervix 410 is positioned within interior passageway 114, 214, or 314 and free to move therein as shown in, for example, FIGs. 4C-4E. FIG. 4F also includes a first phantom line 403 that aligns with a top (as oriented in the figure) of remaining portion of cervix 410B, a second phantom line 404 that aligns with a bottom (as oriented in the figure) of remaining portion of cervix 410B, and a third phantom line 405 that aligns with a bottom (as oriented in the figure) of positioning balloon 130, 230, or 330 when it is not inflated. In some embodiments, third reference line 405 may correspond to a posterior side of the patient while first reference line may correspond to an anterior side of the patient.

[0090] When positioning balloon 130, 230, or 330 is inflated (e.g., expands past third reference line 405) as shown in FIG. 4G, it exerts force F1 on vaginal wall 490, which is opposed by force F2 on cervical neck 410A, which tilts portion 410B of cervix 410 not within cervical cuff balloon 110, 210, or 310 toward third reference line 405 as shown.

[0091] Table 1 provides exemplary dimensions for an internal diameter between a top and a bottom (as oriented in FIGs. 4H-4J) of expandable portions 122, 222, or 322 (represented by a vertical phantom line 450 in FIGs. 4H-4J) and a left and right side (as oriented in FIGs. 4H-4J) of recessed portions 124, 224, or 324 (represented by a horizontal phantom line 460 in FIGs. 4H-4J) of cervical cuff balloon 120, 220, or 330 at a first, second, or third stage of inflation.TABLE 1

[0092] FIG. 4H provides a block diagram of main body 110, 210, or 310 with cervical cuff 120, 22, or 320 at the first stage of inflation, with Occs of inflation media added to cervical cuff balloon 120, 220, or 320 or cervical cuff inner chamber 150, 250, or 350, respectively. At this stage of inflation, vertical phantom line 450A has a length of 35.7mm and horizontal phantom line 460A has a length of 35mm. FIG. 4I provides a block diagram of main body 110, 210, or 310 with cervical cuff 120, 220, or 320 at the second stage of inflation, with 3ccs of inflation media added to cervical cuff balloon 120, 22, or 320 or cervical cuff inner chamber 150, 250, or 350, respectively. At this stage of inflation, vertical phantom line 450B has a length of 26.7mm and horizontal phantom line 460B has a length of 35.3mm. FIG. 4J provides a block diagram of main body 110, 210, or 310 with cervical cuff 120, 22, or 320 at the third stage of inflation, with 5ccs of inflation media added to cervical cuff balloon 120, 22, or 320 or cervical cuff inner chamber 150, 250, or 350, respectively. At this stage of inflation, vertical phantom line 450C has a length of 24.1 mm and horizontal phantom line 460C has a length of 37.2mm. As may be seen in FIGs. 4H-4J and the values of Table 1 , as cervical cuff balloon 120, 22, or 320 inflates, it widens in the horizontal direction and shortens in the vertical direction into an ovoid shape that acts to press cervical neck 410A closed and into a corresponding ovoid shape.

[0093] FIGs. 5A-5H provide various views 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, FIG. 5A is a bottom view of a mold top 501 , FIG. 5B is a bottom view of a waist mold 502, FIG. 5C is a top view of waist mold 502, FIG. 5D is a cross section view of mold top 501 taken along bisecting line 5D of FIG 5A, FIG. 5E is a cross section view of waist mold 502 taken along bisecting line 5E of FIG 5B, FIG. 5F is a top view of bottom mold 503, FIG. 5G is a cross section view of bottom mold 503 taken along bisecting line 5G of FIG 5F, and FIG. 5H is a cross section view of an assembly 505 of top mold 501 , waist mold 502, and bottom mold 503.

[0094] Mold top 501 , waist mold 502, and / or mold bottom 503 may be aligned with one another and / or compressed together to generate a mold for manufacturing one or more of the cervical control systems disclosed herein using any appropriate device, tool, mechanism, and / or system including, but not limited to, alignment pins, alignment holes, alignment grooves, alignment extensions, clamps, presses, alignment blocks, and the like. Material (e.g., silicon) may be injected or otherwise (e.g., pressed) added to / used with mold top 501 , waist mold 502, and / or mold bottom 503 to fabricate one or more of the cervical control systems disclosed herein.

[0095] As may be seen in the bottom view and the cross section view of mold top 501 provided by FIGS. 5A and 5D, respectively, mold top 501 includes a top opening extension 572 sized, configured, and positioned to mold, or manufacture, a top opening of a cervical control system like the top openings disclosed herein. Top mold 501 further includes a pair of upper recessed portion notches 510A sized, configured, and positioned to mold, or manufacture, an upper surface of the recessed portions of a flexible membrane like the recessed portions disclosed herein. Mold top 501 also includes a plurality of cleat notches 516 sized, configured, and positioned to mold, or manufacture a corresponding plurality of cleats that extend from an exterior surface of a flexible membrane of a cervical cuff balloon like the cleats disclosed herein. Mold top 501 further includes an angled plane 506 sized, configured, and positioned to mold, or manufacture an upper surface of a flexible membrane of a cervical cuff balloon like the flexible membranes and cervical cuff balloons disclosed herein. Mold top 501 further includes an extension notch 504 sized, configured, and positioned to mold, or manufacture an upper surface of a groove extending from an outer perimeter of a flexible membrane of a cervical cuff balloon.

[0096] As may be seen in FIGS. 5B, 5C, and 5E, waist mold 502 includes waist mold base 528 and a center aperture 536 sized, configured, and positioned, to allow for the manufacture of an interior passageway of one or more of the cervical control systems disclosed herein via insertion of an interior passageway extension 542 provided by a bottom mold 503 (see e.g., FIGS. 5F and 5G) and a pair of a lower recessed portion notches 510B sized, configured, and positioned to mold, or manufacture, a lower surface of the recessed portions of a flexible membrane like the recessed portions disclosed herein. As may be seen in the cross section viewof assembly 505 provided by FIG. 5H, negative space between top mold 501 , waist mold 502, or bottom mold 503 (i.e., space not occupied by top mold 501 , waist mold 502, or bottom mold 503) may define the shape and configuration of a molded cervical control system like the cervical control systems disclosed herein. In particular, waist mold 502 further includes a cervical cuff forming feature 534 sized and configured to be positioned proximate to angled plane 506 of top mold 501 (see e.g., FIG. 5H) so that negative space between top mold 501 and waist mold 502 forms the cervical cuff balloon flexible membrane, an inner chamber of cervical cuff balloon, and a flexible membrane extension of one or more of the cervical control systems disclosed herein.

[0097] Waist mold 502 further includes a lower extension groove 522 sized, configured, and positioned to cooperate with extension notch 504 to form an underside of a flange, or an extension, of a flexible membrane configured to fit within a groove of a cervical control system formed by groove feature 544 (see e.g., FIG. 5H). Waist mold 502 further includes a positioning balloon groove 555 sized, configured, and positioned to mold a groove into which a flexible membrane of a positioning balloon may be attached as shown in, for example, FIG. 7. Waist mold 502 further includes a fluid conduit feature 532 configured to cooperate with a fluid conduit extension 564 of bottom mold 503 to form a cavity for one or more fluid conduits like the fluid conduits disclosed herein. As may be seen in the cross section of FIG. 5E, cervical cuff forming feature 534 may wrap around and include material used to create an inner chamber of a cervical cuff balloon like the inner chambers disclosed herein.

[0098] FIG. 5F provides a top view of bottom mold 503 and FIG. 5G provides a cross section view of bottom mold 503. Bottom mold 503 includes a bottom mold base 552 with an inner passageway extension 542 that has cleat projections 556 and recessed portion projections 554 extending therefrom. Cleat projections 556 may be sized, positioned, and configured to cooperate with cleat notches 516 of top mold 501 to form cleats that extend from an exterior surface of a flexible membrane of a cervical cuff balloon like the cleats, flexible membranes, and cervical cuff balloons disclosed herein. Recessed portion projections 554 may be sized, positioned, and configured to cooperate with upper recessed portion notches 510A and lower recessed portion notches 510B to form recessed portions of a cervical cuff balloon of a cervical control system like the recessed portions ofcervical cuff balloons disclosed herein. Bottom mold base 552 further includes a cervical control system bottom edge groove 546 sized, positioned, and configured to form the lower, or bottom, edge of a cervical control system like the cervical control systems disclosed herein. In addition, bottom mold base 552 includes a curved groove 548 sized, positioned, and configured to form the lower, or bottom, edge of a flange and / or flexible membrane that forms a cervical cuff balloon like the cervical cuff balloons disclosed herein.

[0099] FIG. 6 is a flowchart illustrating an exemplary method 600 for molding and manufacturing a main body of a cervical control system like the cervical control system bodies disclosed herein. Method 600 may be executed by, for example, a machine, robot, and / or human being.[000100] Initially a mold, or set of mold components (e.g., assembly 505), may be assembled and / or prepared for use to mold a one-piece cervical control system base like cervical control system base 700 (step 605). Execution of step 605 may include, for example, assembling components and / or clamping them together in preparation for introduction of material (e.g., silicon or plastic) therein to mold, or manufacture, the one-piece cervical control system base as shown in, for example, FIG. 5H. Next, the material with which the cervical control system base will be fabricated may be added (e.g., injected, poured, pressed, etc.) to the prepared mold / assembly of mold components (step 610). Once the material has cured, vulcanized, and / or dried, within the mold, the cervical control system base may be removed, or unmolded, from the mold / assembly of mold components (step 615). As an example of how steps 605-615 may be performed, FIG. 7A provides an exploded perspective view of assembly 505 with an exemplary molded cervical control system base 700 that may be manufactured via execution of steps 605 and 610 and unmolded in step 615 and FIG. 7B provides a bisecting cross sectional view of exploded assembly 505 cervical control system base 700. FIG. 7C provides a bisecting cross sectional view of cervical control system base 700, and FIG. 7D provides an angled sectional view of cervical control system base 700.[000101] Cervical control system base 700 includes many of the components of the cervical control systems disclosed herein including a main body 702, a bottom opening 706, an interior passageway 770, a flange 713 with a circumferential extension 752, and a plurality of cleats 716. Main body 702 further includes indentations 715 (formed by positioning balloon groove 555) positioned on anexterior surface of main body 702 and configured for acceptance of a flexible membrane (not shown) to form a positioning balloon as shown in, for example, FIG. 7F, and discussed below. Cervical control system base 700 further includes an open area 755 sized, shaped, and configured to provide a cervical cuff inner chamber 756 for the system once extension 752 is positioned within and / or bonded within a cervical cuff balloon groove 750, thereby forming a fully assembled cervical cuff balloon 708 of a cervical control system 701 as shown in the cross section of FIG. 7E. Cervical cuff balloon 708 further includes recessed portions 724 and expandable portions 712 that may be configured to function in a manner similar to the cervical cuff balloon recessed and expandable portions disclosed herein.[000102] Then, in step 620, a cervical cuff balloon may be assembled or fabricated. In some embodiments, step 620 may be executed by aligning a flange (e.g., flange 713) and / or flange extension (e.g., flange extension 752) of the cervical control system base to a corresponding groove (e.g., cervical cuff balloon groove 750) of the cervical control system base and bonding the flange extension within the cervical cuff balloon groove using, for example, a chemical, thermal, vibrational, and / or mechanical bond. FIG. 7E provides a cross-section view of an assembled cervical control system base 701 , wherein flange extension 752 is positioned with, and bonded to, groove 750, thereby forming cervical cuff inner chamber 756 following execution of step 620.[000103] In step 625, a positioning balloon may be added to the cervical control system base (e.g., cervical control system base 700) by, for example, aligning a positioning balloon flexible membrane within a corresponding groove or indentation (e.g., indentations 715) of the cervical control system base and bonding the positioning balloon flexible membrane to the cervical control system base using, for example, a chemical, thermal, vibrational, and / or mechanical bond, thereby forming a positioning balloon like the positioning balloons disclosed herein. In some embodiments, step 625 may be performed prior to step 620.[000104] In step 630, a first end of a tube (e.g., tube 140, 240, or 340) may be communicatively coupled to an inflation media conduit of cervical control system base 702 via, for example, an inlet and a second end of the tube may be attached to a valve and / or valve housing like the valve housings disclosed herein. FIG. 7F provides a side exploded view of how steps 625 and 630 may be executed to assemble a complete cervical control system 703 as, for example, describedherein. As shown in FIG. 7F, edges of a positioning balloon membrane 730 may be aligned with and / or inserted into indentations 715 as shown to form a positioning balloon like positioning balloon 130, 230, or 330; a first end of tube 140, 240, or 340 may be inserted into cervical control system 701 ; a valve housing like valve housing 142, 242, or 342 may be attached to a second end of tube 140, 240, or 340; and a valve 146, 246A, 246B, 346A, 346B, and / or 346C may be inserted into valve housing 142, 242, or 342 as shown.[000105] FIG. 8 is a flowchart that illustrates an exemplary method 800 for deciding when use of a cervical control system like the cervical control systems disclosed herein is appropriate and / or may be advantageous for a patient; how to insert, adjust, and / or use the cervical control system to, for example, apply compression and / or traction to the cervix in order to, for example, foster regeneration and / or restoration of a cervical mucus plug, prevent pre-term labor and / or delivery, extend gestation of a fetus, and / or treat short cervix, PROM, PPROM, pregnancy complications, and / or prolapse of pelvic organs and / or tissue. Method 800 may be executed by, for example, a clinician, care provider, doctor, surgeon, nurse, or other technician providing medical care to a patient. In some embodiments, one or more steps of method 800 may be executed by and / or with the assistance of a computer or software running on a computer and / or a database such as an electronic medical record database.[000106] Optionally, in step 805, information about a pregnant patient may be received. The information may include, for example, lab testing results for the patient, the patient’s medical history, images of the patient’s anatomy (e.g., pelvic and / or uterine ultrasound images) from which a cervical length, width, structural integrity, and / or dilation may be determined, visual examination of the patient’s anatomy (e.g., vagina and / or cervix), and / or digital examination of the patient’s anatomy. Exemplary lab testing results include, but are not limited to, tests to determine hormone (e.g., estrogen, progesterone, oxytocin, etc.) levels and / or fetal fibronectin (fFN) levels present in, for example, the cervicovaginal fluid. Exemplary medical historical information that may be received includes, but is not limited to, patient age, how many fetuses (e.g., single, twins, triplets, etc.) are present in the patient’s uterus, history of preterm birth for the patient and / or within the patient’s family, history of pregnancy complications for the patient and / or within the patient’s family, history of a short cervix, PROM, and / or PPROM for the patient and / or withinthe patient’s, family whether the patient has undergone a cervical procedure (e.g., surgery, a cerclage, electrosurgical excision procedure (LEEP)), and / or whether the patient has one or more risk factors for pregnancy complications and / or a high risk pregnancy such as advanced age, chronic inflammation, diabetes, and / or high blood pressure. Exemplary examination information that may be received and / or determined via execution of step 805 includes, but is not limited to, a PROM and / or PPROM diagnosis and / or a determination that the cervix is of a particular (e.g., shortened) length that may be less than 25mm, and / or within the range of lengths that includes between 17-39mm, 15-40mm, or 10-45mm.[000107] In step 810, it may be determined (using, for example, some, or all, of the information received and / or determined at step 805) whether the pregnant patient is at risk for and / or has an indication for pre-term birth, pregnancy complications, pelvic (e.g., prolapse) complications, and / or is otherwise a good candidate for use of a cervical control system like the cervical control systems disclosed herein and, if not, method 800 may proceed to step 815 and the patient may be monitored periodically, continuously, and / or on an as-needed basis to, for example, reassess whether or not use of a cervical control system may be beneficial to the patient and / or may extend gestation of the patient’s fetus(es) (e.g., execution of step 810 may be repeated).[000108] In some embodiments, execution of step 810 may include administration of one or more tests and / or examinations that may be general (e.g., to assess maternal and / or fetal health) and / or specific to a particular indication, or problem, the patient is experiencing. For example, if the patient has, or may have, suffered PPROM (in which case, the information received in step 805 may be the patient reporting that her water broke or that she has noticed leaking or discharge) an examination of the patient may be performed to determine if there has been a rupture to the amniotic sac and / or if there is amniotic fluid present in the vagina. These examinations may be, for example, a swab test, such as a ferning test that swabs the posterior fornix and then analyzes secretions from the swap under a microscope to determine if ferning is present and, if so, amniotic fluid is also present in the swabbed secretions; a pH and / or nitrozene test using a drop of vaginal fluid; and / or an immunochromatographic assay (e.g., an AMNISURE™ test strip), and / or immunoassay assay test to detect the presence of amniotic fluid. Alternatively, if the patient is suspected of having short cervix or is experiencingcontractions, a transvaginal and / or abdominal ultrasound may be used to image the patient’s main body to, for example, determine one or more features of the patient’s cervical geometry (e.g., length, width, dilation, etc.). When it is determined in step 810 or is otherwise determined (e.g., by a clinician when steps 805 and / or 810 are not performed) that the pregnant patient is at risk for and / or has an indication for pre-term birth, pregnancy complications, pelvic (e.g., prolapse) complications, and / or is otherwise a good candidate for use of a cervical control system, execution of method 800 may advance to (or initially start with) step 820, wherein a speculum may be placed within the patient’s vagina so that the cervix may be visually observed, measured, and / or digitally examined to, for example, assess dilation, effacement, integrity, sufficiently, length, structural integrity.[000109] In step 825, it may be determined whether or not tools (e.g., speculum, forceps, etc.) for insertion of the cervical control system are needed. When, for example, the cervix is easy to reach and / or has structural integrity tools may not be necessary and the speculum may be removed from the vaginal canal and a cervical control system such as the cervical control systems disclosed herein may be manually inserted into the patient’s vaginal canal and fit around the cervix by, for example, folding the cervical control system to insert it into the vagina, allowing the folded cervical control system to unfold past the introitus, aligning the cervical cuff balloon with the cervix so that the cervix may be positioned within an interior passageway of the cervical control system with the cervical cuff balloon encircling a portion of the cervix as, for example, shown and described herein (step 835). In many cases, the size, shape, and flexibility of the cervical control system allow for digital insertion and placement of the device with no, or minimal pain management interventions (e.g., epidural, local anesthetic, and / or general anesthetic).[000110] When the clinician determines in step 825 that tools may be helpful in placing the cervical control system, as may occur when, for example, the cervix is hard to reach and / or display’s a higher degree of softness such that it may be better / more effective to use a cervical stabilization system (e.g., forceps) to first stabilize the cervix and then place the cervical control system and / or use the cervical stabilization system to pull the cervix through the interior passageway of the cervical control system, the clinician may proceed with doing so (step 830). In some embodiments, step 830 may be performed after the speculum inserted instep 820 has been removed by digitally, or manually, inserting the cervical control system into the vagina and positioning the cervical cuff balloon thereof proximate to the cervix. Then, the cervical stabilization system may be used to ease the cervical tissue into the interior passageway of the cervical control system. This procedure may also be performed without pain management interventions for the reasons provided above and because, for example, the cervix is not being pierced, excessively squeezed, or cut by the cervical stabilization system when positioning it within the interior passageway.[000111] Once the cervical control system is in place around the cervix following execution of step 830 or 835, at step 840 the clinician may optionally reintroduce the speculum. In step 845, the cervical cuff balloon may be inflated with inflation media (e.g., saline, air, etc.) so that it engages and compresses the cervix. When used, the speculum may assist a clinician in visualizing placement of the cervical control system and / or inflation of cervical cuff balloon to, for example, ensure secure fit and / or proper angulation of the cervix.[000112] Once cervical cuff balloon is inflated (step 845), a positioning balloon of the cervical control system may be inflated (step 850) with inflation media to wedge the cervical control system within the vagina and / or orient the cervical control system and / or cervix as clinically necessary and / or desired. In some embodiments, the positioning balloon is positioned within the vagina and inflated to change an orientation of the cervix to, for example, direct weight from the uterus away from the cervix and / or decrease pressure on the cervix from the weight of the uterus.[000113] In step 855, the clinician can remove the speculum (when used) and, in some cases, digitally check placement of the cervical control system and / or use an image (e.g., ultrasound) to verify correct placement of the cervical control system and, when the cervical control system is correctly placed / resident within the vagina and encircling the cervix, a valve housing and a portion of a tube of the cervical control system may be placed within the vagina (step 860) where it may remain during use.[000114] Optionally, in step 865, saline and / or medication may be applied to the cervix prior to, and / or during, execution of steps 805-860, and / or following execution step 860 to, for example, anesthetize the cervical tissue, rinse the cervix and / or surrounding tissue, reduce a risk of infection, and / or treat the cervical tissue with a medication. In some cases, the cervical control system placed around thepatient’s cervix is cervical control system 300, and, in these cases, the saline and / or medication may be applied to the patient’s cervix via the internal channel 360 and / or ports 362 therein.[000115] Optionally, in step 870, an indication of patient condition and / or cervical control system performance may be received and / or determined via, for example, patient examination and / or information provided by the patient (e.g., experiences of discomfort, pain, frequency of contractions, a leaking sensation, feeling the cervical control system and / or cervical control device move, discomfort caused by displacement of the cervical control system and / or cervical control device, and / or the presence of discharge). Patient examination may include, but is not limited to, internal digital examination, palpation of the abdomen, direct visual observation of the cervix via use of, for example, a speculum, direct visual observation of the vaginal canal for signs of discharge, bleeding, and / or amniotic fluid (e.g., a flow and / or pool of amniotic fluid), use of an imaging technique such as ultrasound and / or MRI, and / or measuring and / or monitoring biomarkers (e.g., blood test, urinalysis, swab tests to indicate the presence of, for example, amniotic fluid and / or bacteria in the vagina and / or cervix, or localized or general temperature monitoring of the patient) to, for example, detect a rupture of membranes (PROM or PPROM), infection, and / or hormonal changes that may indicate, for example, an onset of labor and / or fetal distress. In many cases, physical and / or imaging examination of the patient may focus on the patient’s cervical and / or vaginal tissue with an aim of ensuring the cervical control system and / or cervical control device is working as intended to, for example, control and / or support the cervix, facilitate replenishment of amniotic fluid, facilitate rebuilding of a cervical mucus plug, and / or delay onset of labor and delivery of a fetus without damaging or scarring the cervical or vaginal tissue. When patient examination includes ultrasound imaging, the ultrasound imaging may be transabdominal to, for example, look at the fetus (e.g., organs, heartbeat, etc.), maternal tissue (e.g. uterus, cervix, placenta, etc.), and / or amniotic fluid volume within the uterus. Additionally, or alternatively, ultrasound imaging may be transvaginal to image, for example, reproductive organs and, in particular, the cervix to, for example, measure cervical dimensions (e.g., length, dilation, width, etc.). Indications of cervical control system performance include, but are not limited to, an absolute and / or relative position and / or orientation of the cervical control system, an orientation of the patient’s cervix, a size and / or shapeof the patient’s cervix (e.g., too thin, too short, sufficiently long, etc.). In some embodiments, information received in step 870 may include a length of time a patient has been wearing a cervical control system, comorbidities of the patient (e.g., gestational diabetes, high blood pressure, etc.), current pressure of inflation media within the cervical cuff balloon and / or positioning balloon, and / or a length of time since a prior adjustment (e.g., filling and / or emptying of inflation media) of cervical control system position, and / or degree of inflation. In some embodiments, the data received in step 870 may be responsive to a routine examination of the patient (e.g., a pre-natal checkup) and / or may be responsive to a patient complaint and / or change in patient condition.[000116] In step 875, it may be determined whether or not an adjustment of the cervical control system and / or component thereof is necessary and / or desired responsively to the data and / or determinations of step 870. In some embodiments, execution of step 880 may include a clinician adjusting a position and / or degree of inflation of a cervical cuff balloon and / or positioning balloon of the cervical control system responsively to execution of step 870.[000117] In some embodiments, method 800 may be performed periodically (e.g., daily, weekly, bi-weekly, and / or monthly) following implantation of the cervical control system into the patient to, for example, monitor and / or enhance performance and / or make adjustments to position and / or level of inflation to, for example, improve efficacy and / or comfort and / or to reduce risk of tissue trauma and / or scarring. For example, in some embodiments, method 800 may be executed every three days to monitor cervical tissue for irritation and / or trauma and when such irritation or trauma is detected, the cervical cuff balloon and / or the positioning balloon may be deflated so that an orientation and / or position of the cervical control system and / or cleats present on the cervical cuff balloon may be adjusted. Additionally, or alternatively, in some embodiments, step 880 may be performed periodically as a standard of care and / or best practice and, in these embodiments, execution of steps 870 and / or 875 may be optional.[000118] For embodiments of the cervical control system that have tube configured to extend away from the cervical control system and / or a valve system accessible outside the main body, step 880 may be performed by extracting a portion of the tube and the valve system from the vagina for easy access without the need to remove the cervical control system from the patient and, in this way, a level ofinflation, position, and / or angle of orientation of the cervical control system and / or cervical control device may be adjusted in situ.[000119] In some embodiments, the cervical control system may be placed via execution of some, or all, of the steps of method 800 to treat and / or mitigate 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, pressure, pain, incontinence (e.g., urinary incontinence), and so on. Such symptoms may also be treated herein without the underlying condition of pelvic organ prolapse.[000120] Additionally, or alternatively, method 800 and / or steps thereof may be executed to mitigate the effects of and / or treat PPROM or PROM. In these cases, positioning of the cervical control system around the patient’s cervix may act to hold the cervix closed and prevent further escape, or leaking, of amniotic fluid from the ruptured amniotic sac, which may allow for the replenishment of the amniotic fluid within the amniotic sac.[000121] In some embodiments, the various different components, and functions of the embodiments of the cervical control systems described and illustrated herein may be adapted for use with any of the other embodiments disclosed herein. Thus, the cervical control systems of the various illustrative embodiments detailed above may provide a selectively adjustable cervical control system for controlling and / or supporting an insufficient cervix, mitigating leaks of amniotic fluid due to ruptured amniotic sac membranes, fostering growth and / or regeneration of cervical mucus plugs, and / or supporting pelvic organs to, for example, promote extended gestation of pre-term pregnancies, reduce pregnancy complications, and improve patient (pregnant woman and baby) outcomes.[000122] The methods disclosed herein may include certain actions taken by a practitioner; however, the methods can also include any user or third-party instruction of those actions, either expressly or by implication. For example, actions such as “positioning a device” include “instructing positioning of a device.”[000123] The ranges disclosed herein also encompass any and all overlap, subranges, and combinations thereof. Language such as “up to,” “at least,” “greater than,” “less than,” “between,” and the like includes the number recited. Numbers preceded by a term such as “about” or “approximately” include the recited numbers and should be interpreted based on the circumstances (e.g., as accurate asreasonable under the circumstances, for example ±5%, ±10%, ±15%, etc.). For example, “about 4 inches” includes “4 inches.” Phrases preceded by a term such as “substantially” include the recited phrase and should be interpreted based on the circumstances (e.g., as much as reasonably possible under the circumstances). For example, “substantially linear” includes “linear.” Unless stated otherwise, all measurements are at standard conditions including temperature and pressure. In addition, all directional reference terms (e.g., top, bottom, upper, lower, etc.) used in the preceding discussions of the figures are made with reference to the orientations shown in the respective figure.[000124] The phrase “at least one of’ is intended to require at least one item from the subsequent listing, not one type of each item from each item in the subsequent listing. For example, “at least one of A, B, and C” can include A; B; C; A and B; A and C; B and C; or A, B, and C. Changes and modifications in the specifically described embodiments can be carried out without departing from the principles of the present disclosure. Each of the disclosed aspects and examples of the present disclosure may be considered individually or in combination with other aspects, examples, and variations of the disclosure. In addition, unless otherwise specified, none of the steps of the methods of the present disclosure are confined to any particular order of performance.

Claims

CLAIMSWHAT IS CLAIMED IS:1 . An assembly for molding a main body of a cervical control system, the mold comprising: a top mold configured to cooperate with a waist mold; the waist mold comprising a groove feature configured to form a groove within the main body, wherein negative space between the top mold and waist mold is configured to generate a flange and a flange extension of the main body, the flange extension being configured for insertion into the groove of the main body, thereby forming a cervical cuff balloon of the main body; and a bottom mold configured to cooperate with the waist mold.

2. The assembly of claim 1 , wherein the bottom mold further comprises a fluid conduit extension configured to cooperate with a fluid conduit feature of the waist mold to form a fluid conduit in the main body that is in communication with the cervical cuff balloon.

3. The assembly of claim 2, wherein the bottom mold further comprises an inlet feature configured to form an inlet in communication with the fluid conduit of the main body, the inlet being configured to enable attachment of a tube to the main body.

4. The assembly of any of claims 1 , 2, or 3, wherein the waist mold further comprises a positioning balloon feature sized, configured, and positioned to generate a feature in the main body configured to cooperate with a flexible membrane to create a positioning balloon.

5. The assembly of claim 1 , wherein the bottom mold further comprises a first fluid conduit extension configured to cooperate with a first fluid conduit feature of the waist mold to form a first fluid conduit in the main body that is in communication with the cervical cuff balloon and a second fluid conduit extension configured to cooperate with a second fluid conduit feature of the waist mold to form a second fluid conduit in the main body that is in communication with the positioning balloon.

6. The assembly of claim 5, wherein the bottom mold further comprises a first inlet feature configured to form a first inlet in communication with the first fluid conduit of the main body and a second inlet feature configured to form a secondinlet in communication with the second fluid conduit of the main body, the first and second inlets being configured to enable attachment of a bi-lumen tube to the main body.

7. The assembly of any of the above claims, further comprising: an alignment mechanism configured to align at least one of the top mold and the waist mold, the waist mold and the bottom mold, and the top mold, waist mold, and bottom mold.

8. The assembly of any of claims 1-7, wherein the main body is a one-piece main body.

9. A method for manufacturing a cervical control system comprising: adding material to the assembly of any of claims 1 -8; unmolding, when the material has cured, the main body from the assembly; and forming the cervical cuff balloon by inserting the flange extension into the groove.

10. The method of claim 9, wherein the bottom mold further comprises a fluid conduit extension configured to cooperate with a fluid conduit feature of the waist mold to form a fluid conduit in the main body that is in communication with the cervical cuff balloon.11 .The method of claim 10, wherein the bottom mold further comprises an inlet feature configured to form an inlet in communication with the fluid conduit of the main body, the inlet being configured to enable attachment of a tube to the main body, the method further comprising: attaching a first end of a tube to the inlet; and attaching a valve housing to a second end of the tube.

12. The method of any of claims 9-11 , further comprising: attaching a positioning balloon membrane to the main body.

13. The method of any of claims 9-12, wherein the main body is a one-piece main body.

14. A method for manufacturing a main body of a cervical control system comprising: adding material to a mold configured to generate the main body of the cervical control system, the mold including features to generate corresponding features of the main body including an interior passageway and a component configured to be assembled to form a cervical cuff balloon;unmolding, when the material has cured, the main body from the mold, the main body comprising the interior passageway and the component configured to be assembled to form an inflatable cervical cuff; and forming the cervical cuff balloon using the component configured to be assembled to form a cervical cuff balloon.

15. The method of claim 14, wherein the mold features further comprise a groove portion configured to generate a groove in the main body that cooperates with, and accepts, insertion of a flange extension of the main body, the mold further comprising a flange extension portion configured to generate the flange extension, wherein the main body comprises the groove and the flange extension and forming the cervical cuff balloon comprises: inserting the flange extension into the groove; and causing the flange to be bonded to the groove.

16. The method of claim 14, further comprising: attaching the positioning balloon to the main body using the features configured to cooperate with a positioning balloon.

17. The method of any of claims 14-16, wherein the mold further includes features configured to generate an inlet portion in communication with the inflation media conduit portion and the main body further comprises an inlet in communication with the inflation medica conduit that corresponds to the inlet portion.

18. The method of claim 17, wherein the mold further includes features configured to generate an inlet portion in communication with the inflation media conduit portion and the main body further comprises an inlet in communication with the inflation medica conduit that corresponds to the inlet portion.

19. The method of claim 17, further comprising: inserting a first end of a tube into the inlet.

20. The method of claim 19, further comprising: attaching a second end of the tube to a valve housing, the valve housing include a valve configured to cooperate with a source of inflation media when inflating or deflating the cervical cuff balloon.

21. The method of any of claims 14-20, wherein the main body is a one-piece main body.

22. A method of using a cervical control system, the method comprising:inserting a main body of cervical control system into a patient’s vagina, the cervical control system including a main body with an interior passageway, an inflatable cervical cuff encircling a portion of the interior passageway and including an opening to the interior passageway, and an inflatable positioning balloon covering a portion of an exterior surface of the main body; positioning a patient’s cervix within the opening of the cervical cuff balloon; inflating the cervical cuff balloon to secure the cervix within the opening of the cervical cuff balloon, wherein inflation of the cervical cuff balloon exerts traction and compressive force on the cervix; and inflating the positioning balloon after the cervical cuff balloon is inflated, wherein inflation of the positioning balloon adjusts an angle of orientation of the cervix.

23. The method of claim 22, wherein the main body includes an inflation media conduit in fluid communication with at least one of the cervical cuff balloon and positioning balloon, the cervical control system further including a tube with a first end in fluid communication with the inflation media conduit and a second end in communication with a valve.

24. The method of claim 23, wherein the tube is of sufficient length to allow access to the valve without changing a position of the cervical control system relative to the cervix, the method further comprising: accessing the valve housing by extracting a portion of the tube from the patient’s vagina; adjusting a volume of inflation media within at least one of the cervical cuff balloon via cooperation of an inflation media source in communication with the valve.

25. The method of claim 24, wherein the valve is resident within a valve housing, the valve housing also including a pressure sensing device, the method further comprising: accessing the valve housing by extracting a portion of the tube from the patient’s vagina; and adjusting a volume of inflation media within at least one of the cervical cuff balloon and the positioning balloon responsively to a pressure reading from the pressure sensing device.

26. The method of claim 22, wherein the tube is of sufficient length to allow access to the valve without changing a position of the cervical control system relative to the cervix, the method further comprising: accessing the valve housing by extracting a portion of the tube from the patient’s vagina; decreasing a volume of inflation media within the cervical cuff balloon; adjusting a position of the cervix within the opening; inflating the cervical cuff balloon; and placing the portion of the tube into the patient’s vagina.

27. The method of claim 22, wherein the tube is of sufficient length to allow access to the valve without changing a position of the cervical control system relative to the cervix, the method further comprising: receiving an indication of the cervical control system’s performance; and adjusting at least one of a degree of inflation of the cervical cuff balloon, a degree of inflation of the positioning balloon, an orientation of the cervical cuff balloon, and an orientation of the positioning balloon responsively to the indication.

28. The method of any of claims 22-27, wherein the cervical control system is digitally inserted into the patient’s vagina and positioned around the patient’s cervix.

29. The method of any of claims 22-28, wherein inflating the cervical cuff balloon elongates the cervix.

30. The method of any of claims 22-29, wherein inflating the cervical cuff balloon facilitates growth of a cervical mucus plug.31 .The method of any of claims 22-30, wherein the cervical control system is used to mitigate a risk factor for pre-term labor for the patient.

32. The method of any of claims 22-31 , wherein the cervical control system is used responsively to the patient being associated with an indication of pre-term labor.

33. The method of any of claims 22-32, wherein the cervical control system is placed responsively to the patient being diagnosed with a short cervix.

34. The method of any of claims 22-33, wherein the cervical control system is placed responsively to the patient being associated with an indication of pelvic organ prolapse.

35. The method of any of claims 22-34, wherein the cervical control system is placed responsively to the patient being diagnosed with premature rupture of membranes (PROM) or preterm premature rupture of membranes (PPROM).

36. The method of any of claims 22-35, wherein the cervical control system is used to control the patient’s cervix.

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