Device for reduction or prevention of preterm labor

Abstract

To provide a device for reinforcing and supporting the cervix so as to promote pregnancy period extension of a patient who has developed complications by preterm labor.SOLUTION: A medical device is for supporting a patient's cervix, such as in an event of an insufficient cervix or uterine prolapse. The device includes: a main body 102 configured for placement in a vagina; a proximal opening 104 at an upper portion of a body; and a distal opening at a lower portion of the body. A portion of the body engages and anchors the device along a vaginal wall proximate a cervical opening. An expandable cuff 108 at the proximal opening is expandable to circumscribe an exterior of the cervix. The cuff is expandable inward toward the cervix, or downward away from a uterus, or both inward and downward. The cuff may include multiple features, such as a recessed portion 110 and an enlargeable portion arranged adjacent one another, in which the recessed portion may permit blood flow to lower cervical tissue.SELECTED DRAWING: Figure 4

Description

[Technical Field]

[0001] The present invention relates to reproductive, pregnancy, and prenatal health, and in particular to devices for the reduction or prevention of preterm labor. [Background technology]

[0002] The most common reason for infant death is complications from preterm labor. Several factors contribute to preterm labor, most commonly including cervical insufficiency, also medically referred to as a "short cervix." When a short cervix occurs in a singleton pregnancy (i.e., a pregnancy with a single fetus), a common intervention method involves the placement of sutures within the cervix in an attempt to delay labor, known as a cervical cerclage. Generally, interventions for cervical insufficiency in multiple pregnancies (i.e., multiple pregnancies) are limited and may provide limited effectiveness. When placed within a patient, some commonly known or commercially available cervical support devices constrict or block the flow of blood / fluids to the lower extremities of the cervix. Summary of the Invention [Means for solving the problem]

[0003] The present invention provides a device that reinforces and supports the cervix to promote pregnancy extension in patients complicated by preterm labor due to an insufficient cervix. The device is referred to herein as a cervical support device. The device provides selectively adjustable or customizable support to a patient's cervix and can help delay labor in both single and multiple pregnancies in individuals with an insufficient cervix. In some configurations, the device can be utilized to support or reduce the effects of pelvic organ prolapse. The device includes one or more inflatable cuffs or bladders that are selectively inflatable and deflatable to provide a desired amount of support and / or positional correction to the cervix. The cuffs may be independently inflatable or collectively inflatable. The device can include an upper or proximal cuff for engaging and supporting the cervix, uterus, and / or fetus, and outer and / or lower distal cuffs for engaging the patient's vaginal wall to support the device proximate to the cervix. The proximal cuff may be utilized to apply a clamping compressive force to the exterior of the lower portion of the cervix in an attempt to hold the cervix closed. The cuff of the device may include one or more individually accessible (i.e., inflatable / deflate) bladders that cooperate with each other to provide the desired support. The proximal cuff may be configured to apply a sufficient amount of compressive pressure to the cervix while allowing blood / fluid perfusion within the cervix (e.g., by inflating the expandable portion of the cuff). Cervical anatomy may vary in nominal outer dimensions from patient to patient, and an insufficient cervix may (and is likely to) continue to contract as the pregnancy progresses. Thus, the adjustable functionality of the cervical support device of the present invention may allow a care provider (i.e., a healthcare provider such as a doctor, midwife, or nurse) to customize support for a specific patient's cervix by directing cuff inflation / deflation. The distal cuff may be utilized to adjust the position of the device within the patient's vagina, for example, to elevate or redirect the device relative to the cervix.Optionally, the device may be inverted so that the distal opening faces toward the cervix, allowing the device to provide support to the pelvic organs (e.g., the sac and uterus) in the event of prolapse (e.g., uterine or cervical prolapse) (without directly contacting the lower portion of the cervix). The device may also be beneficial in reducing or limiting the risk of infection and / or prolonging fetal development in the event of premature rupture of membranes (PROM) and preterm premature rupture of membranes (PPROM).

[0004] According to one aspect of the present invention, a cervical support and reinforcement device is provided for supporting a patient's cervix and includes a main body sized and shaped for placement within the patient's vagina. The main body defines an interior passageway having a proximal opening at an upper portion of the body and a distal opening at a lower portion of the body. A portion of the body's periphery is provided for engaging and pressing against or partially embedding in the vaginal wall to secure the device near the cervical opening. An expandable annular cuff is provided around the interior of the body immediately adjacent the proximal opening, such that the cuff defines at least a portion of the proximal opening. The cuff is expandable toward the axial center of the proximal opening to circumscribe an outer surface portion of the lower cervix. The cuff is expandable from a neutral state to an expanded state, thereby reducing the area of ​​the proximal opening. In other words, when inflated, the cuff expands inward to clamp against the outer surface of the cervix. The cuff may include one or more recessed or minimally expandable portions and one or more expansion or expandable portions adjacent the recessed portions. The expansion portion is expandable toward the axial center of the proximal opening to clamp the cervix, and the recess of the cuff remains generally uninflated or unexpanded to allow blood flow from the upper to the lower cervical tissue. Optionally, the cervical support device may include an annular ridge along the inner circumference of the cuff to grip or engage the outer surface of the cervix to provide an improved grip around the cervix when the cuff is inflated.

[0005] In one aspect, the primary body of the device is a hemispheroid formed with a hemispheroid shape defining a proximal opening at an upper portion of the hemispheroid and a distal opening at a lower portion of the hemispheroid. The proximal opening has a smaller area than the distal opening. An exterior portion of the body at or near the distal opening can be sized and shaped to engage the vaginal wall to support the device proximate the cervical opening.

[0006] In another aspect, the cuff is expandable radially inward toward the axial center of the proximal opening and downwardly away from the cross section of the proximal opening and away from the uterus as the cuff expands around the cervix, with the inward radial expansion of the proximal cuff acting to clamp the outer portion of the cervix, while the downward expansion acts to pull or push the cervix downwardly and away from the uterus.

[0007] In yet another embodiment, the cuff includes two or more adjacent bladders positioned, shaped, and dimensioned such that, upon inflation of one or more of the inflatable bladders, the cuff (i) expands radially inward and / or downwardly away from the transverse plane of the proximal opening. For example, the cuff may include a first inflatable bladder coaxial with the proximal opening and a second inflatable bladder coaxial with the first inflatable bladder and the proximal opening. Preferably, the cuff is expandable from a neutral state to an expanded state in which portions of the cuff expand both radially inward toward the axial center of the proximal opening and downwardly away from the transverse plane of the proximal opening and away from the uterus, thereby exerting a downward force on the external surface of the cervix.

[0008] In yet another aspect, the radial cross section of the cuff (e.g., the enlarged portion of the cuff) is formed with a non-uniform wall thickness such that upon expansion, the non-uniform walled cuff configuration causes the cuff to expand both radially inward and downward away from the cross section of the proximal opening.

[0009] In yet another aspect, the cervical support device includes an annular rim on an upper portion of the main body that flares upwardly away from the cross-section of the proximal opening. When the device is placed in a patient's vagina, the annular rim first receives the lower end of the cervix and then guides the cervix toward the proximal opening, thereby assisting the provider in properly positioning the device adjacent to the cervix.

[0010] A fluid conduit may be disposed within the main body of the cervical support device with a fluid connection to the cuff for introducing or removing fluid (e.g., liquid or air) from the cuff. A valve may be provided in fluid communication with the fluid conduit at an end opposite the cuff. The valve may removably receive a portion of an inflation device (e.g., a pump) operable to inflate the cuff without removing the device from the patient's vagina. The valve may include a check valve, such as a duckbill valve, to minimize backflow of fluid after it is directed into the cuff.

[0011] In yet another embodiment, the cervical support device includes another or second expandable annular cuff near the lower portion and / or outer (convex) curvature of the main body, such as immediately proximal to the distal opening. Where applicable, this additional cuff is hereinafter referred to as the "distal cuff," while the previously described cuff is hereinafter referred to as the "proximal cuff." The distal cuff is expandable outward, away from the axial center of the distal opening, so that the distal cuff expands toward and contacts the vaginal wall. The distal cuff is expandable from a neutral state to an expanded state in which the circumference of the distal cuff increases (compared to its circumference in the neutral state) to expand and contact the vaginal wall, securing the device thereto. The additional or distal cuff may be in fluid communication with a fluid conduit, such as those described above, for receiving or releasing fluid to / from the distal cuff. A single fluid conduit may be provided in communication with each cuff of the device, or dedicated fluid conduits may be provided for each cuff and / or each individually accessible bladder of a cuff.

[0012] In another form of the invention, a cervical support and reinforcement device is provided for supporting a patient's cervix and includes a main body sized and shaped for placement within the patient's vagina. The main body has an upper portion defining a proximal opening and a lower portion defining a distal opening. An outer surface portion of the body is configured to engage the vaginal wall to support or secure the device proximate the cervical opening. The device includes an expandable annular cuff within the body near the proximal opening, the cuff defining at least a portion of the proximal opening. At least a portion of the cuff is expandable from a neutral state to an expanded state in which the cuff expands both (i) radially inward toward the axial center of the proximal opening to clamp an outer surface portion of the cervix and (ii) downwardly away from the transverse plane of the proximal opening and away from the uterus to apply a downward force to the outer surface of the cervix.

[0013] In one embodiment, the cuff includes one or more recesses and one or more enlarged portions in a spaced apart configuration. The enlarged portions are expandable downwardly toward the axial center of the proximal opening and away from the transverse plane of the proximal opening. The recesses in the cuff can permit blood flow from upper to lower cervical tissue extending through the cuff.

[0014] In another aspect, the radial cross-section of the cuff has a non-uniform wall thickness such that upon expansion, the cuff is expandable both radially inward and downward away from the cross-section of the proximal opening based on material properties of the non-uniform wall thickness.

[0015] In yet another embodiment, the cuff includes multiple inflatable bladders that are adjacent and coaxial with one another and are arranged such that inflation of one or more of the bladders causes the cuff to expand radially inward toward an axial center of the proximal opening and / or downwardly away from a transverse plane of the proximal opening.

[0016] In another aspect, the cervical support device includes an expandable distal annular cuff disposed on a lower portion of the body immediately proximal to the distal opening, the distal cuff expandable outwardly away from the axial center of the distal opening and expands toward and into contact with the vaginal wall to securely anchor the device within the vagina. [Effects of the Invention]

[0017] Thus, the cervical support and reinforcement device of the present invention provides a customizable and adjustable device for supporting the cervix of patients with an insufficient cervix that may progress to preterm labor. The device includes one or more inflatable cuffs and / or individually accessible inflatable bladders that allow a care provider to direct a compressive force at a desired location about the lower portion of the patient's cervix. The adjustable nature of the device allows the provider to adjust the amount of pressure applied to the cervix or adjust the orientation of the device relative to the cervix and vagina without any need to remove the device through the vagina or directly manually manipulate the device. The cuffs may include various dimensional features or structural aspects to expand the cuffs both radially inward toward the cervix and downward away from the uterus to apply an oblique, inward, downward force to the cervix.

[0018] These and other objects, advantages, goals and features of the present invention will become apparent upon review of the following specification in conjunction with the drawings. [Brief explanation of the drawings]

[0019] [Figure 1] FIG. 1 is a sagittal view of a patient with multiple pregnancies showing placement of the cervical support and reinforcement device of the present invention. [Figure 2] FIG. 2 is another sagittal view of the patient of FIG. 1, showing the cervical support device with the upper inner cuff in an inflated or expanded state in a side cross-sectional view. [Figure 3]FIG. 2 is a top perspective view of the cervical support device of FIG. 1, with the upper inner cuff shown in a deflated or neutral state. [Figure 4] FIG. 2 is another top perspective view of the cervical support device of FIG. 1, with the upper inner cuff shown in an inflated state. [Figure 5] FIG. 4 is a side cross-sectional view taken along line VV of FIG. 3, with the upper inner cuff shown in a deflated state. [Figure 6] 6 is another cross-sectional side view taken along line VI-VI of FIG. 4, with the upper inner cuff shown in an inflated state. [Figure 7] FIG. 10 is a side cross-sectional view of another cervical support and reinforcement device according to the present invention, with the upper inner cuff shown in a deflated or neutral state. [Figure 8] FIG. 8 is another side cross-sectional view of the cervical support device of FIG. 7, with the upper inner cuff shown in an inflated or expanded state. [Figure 9] FIG. 10 is a radial side cross-sectional view of a portion of another expandable or inflatable cuff for a cervical support device. [Figure 10] FIG. 10 is a radial side cross-sectional view of a portion of another expandable or inflatable cuff for a cervical support device. [Figure 11] FIG. 10 is a radial side cross-sectional view of a portion of another expandable or inflatable cuff for a cervical support device. [Figure 12] FIG. 10 is a radial side cross-sectional view of a portion of another expandable or inflatable cuff for a cervical support device shown in a contracted or neutral state. [Figure 13] 13 is another radial side cross-sectional view of a portion of the inflatable cuff of FIG. 12 shown in an inflated or expanded state. [Figure 14] FIG. 10 is a side cross-sectional view of another cervical support and reinforcement device according to the present invention, with the upper inner cuff shown in a deflated or neutral state. [Figure 15] FIG. 15 is another side cross-sectional view of the cervical support device of FIG. 14, with the upper inner cuff shown in an inflated or expanded state. [Figure 16]FIG. 15 is another side cross-sectional view of the cervical support device of FIG. 14 shown in place around the lower portion of the cervix with the upper inner cuff shown in a deflated state. [Figure 17] FIG. 17 is another side cross-sectional view of the cervical support device of FIG. 16 showing the lower portion of the cervix extending into the opening formed by the upper inner cuff. [Figure 18] FIG. 18 is another side cross-sectional view of the cervical support device of FIG. 17, shown with the upper inner cuff in an inflated state and engaging or impinging on the outer surface of the lower portion of the cervix. [Figure 19] FIG. 10 is a side cross-sectional view of another cervical support and reinforcement device according to the present invention, in which the cervical support device is shown with the lower outer cuff in a contracted or neutral state. [Figure 20] FIG. 20 is another side cross-sectional view of the cervical support device of FIG. 19, with the lower outer cuff shown in an inflated or expanded state. [Figure 21] FIG. 1 is a radial side cross-sectional view of a pair of adjacent expandable or inflatable cuffs shown in a deflated or neutral state. [Figure 22] 22 is another radial side cross-sectional view of the inflatable cuff of FIG. 21, the cuff shown in an inflated or expanded state. [Figure 23] FIG. 10 is a top perspective view of another cervical support and reinforcement device according to the present invention, with the upper inner cuff and lower cuff shown in their respective contracted or neutral states. [Figure 24] FIG. 24 is a bottom view of the cervical support device of FIG. 23. [Figure 25] FIG. 10 is a top perspective view of another cervical support and reinforcement device according to the present invention, with the upper inner cuff and lower cuff shown in their respective contracted or neutral states. [Figure 26] FIG. 26 is an exploded side perspective view of the cervical support device of FIG. 25. [Figure 27] 27 is an exploded cross-sectional view of the components of the cervical support device of FIG. 25 taken along line XXVII-XXVII of FIG. 25. [Figure 28]FIG. 26 is another top perspective view of the cervical support device of FIG. 25, with the upper inner cuff shown in an inflated or expanded state. [Figure 29] 26 is a side cross-sectional view taken along line XXVI-XXVI of FIG. 25, with the upper inner cuff and the lower cuff each shown in a deflated state. [Figure 30] FIG. 30 is another side cross-sectional view of the cervical support device of FIG. 29, shown with the upper inner cuff in an inflated state and the lower cuff in a deflated state. [Figure 31] FIG. 26 is a side cross-sectional view taken along line XXXI-XXXI of FIG. 25, with the upper inner cuff and the lower cuff each shown in an inflated state. [Figure 32] FIG. 30 is another side cross-sectional view of the cervical support device and quadruple lumen inflation device of FIG. 29 coupled with a valve system for inflating the cuff of the device. [Figure 32A] FIG. 33 is an enlarged view of the area designated XXXIIA in FIG. 32. [Figure 32B] FIG. 33 is a side perspective view of the quadruple lumen of FIG. 32. [Figure 33] FIG. 26 is a sagittal view of a patient with a single pregnancy, including a side cross-sectional view of the cervical support device of FIG. 25 within the patient's vagina to support the patient's cervix. [Figure 34] FIG. 26 is a radial side cross-sectional view of the expandable or inflatable cuff of the cervical support device of FIG. 25. [Figure 35] FIG. 10 is a top perspective view of another cervical support and reinforcement device according to the present invention, with the upper inner cuff and lower cuff shown in their respective contracted or neutral states. [Figure 36] FIG. 10 is a side perspective view of another cervical support and reinforcement device according to the present invention, with the upper inner cuff shown in a deflated or neutral state. [Figure 37] FIG. 37 is a cross-sectional side perspective view taken along line XXXVII-XXXVII of FIG. 36. [Figure 38] 1 is a radial side cross-sectional view of an exemplary cleat or tooth for an expandable or inflatable cuff according to the present invention. [Figure 39]1 is a radial side cross-sectional view of an exemplary cleat or tooth for an expandable or inflatable cuff according to the present invention. [Figure 40] 1 is a radial side cross-sectional view of an exemplary cleat or tooth for an expandable or inflatable cuff according to the present invention. [Figure 41] 1 is a radial side cross-sectional view of an exemplary cleat or tooth for an expandable or inflatable cuff according to the present invention. [Figure 42] 1 is a radial side cross-sectional view of an exemplary cleat or tooth for an expandable or inflatable cuff according to the present invention. [Figure 43] FIG. 10 is a front view of an exemplary cleat or tine for an expandable or inflatable cuff for use with the cervical support device of the present invention. [Figure 44] FIG. 10 is a front view of an exemplary cleat or tine for an expandable or inflatable cuff for use with the cervical support device of the present invention. [Figure 45] FIG. 10 is a front view of an exemplary cleat or tine for an expandable or inflatable cuff for use with the cervical support device of the present invention. [Figure 46] FIG. 10 is a front view of an exemplary cleat or tine for an expandable or inflatable cuff for use with the cervical support device of the present invention. [Figure 47] FIG. 10 is a front view of an exemplary cleat or tine for an expandable or inflatable cuff for use with the cervical support device of the present invention. [Figure 48] FIG. 10 is a front view of an exemplary cleat or tine for an expandable or inflatable cuff for use with the cervical support device of the present invention. [Figure 49] FIG. 10 is a front view of an exemplary cleat or tine for an expandable or inflatable cuff for use with the cervical support device of the present invention. [Figure 50] FIG. 10 is a front view of an exemplary cleat or tine for an expandable or inflatable cuff for use with the cervical support device of the present invention. [Figure 51] FIG. 10 is a side perspective view of another cervical support and reinforcement device according to the present invention, with the upper inner cuff and lower outer cuff shown in their respective contracted or neutral states. [Figure 52] FIG. 52 is a cross-sectional side perspective view taken along line LII-LII of FIG. 51. [Figure 53] FIG. 53 is another cross-sectional side perspective view of the cervical support device of FIG. 52 shown with the upper inner cuff in a deflated state and the lower outer cuff in an inflated or expanded state. [Figure 54] FIG. 54 is another cross-sectional side perspective view of the cervical support device of FIG. 53, showing the tube and valve assemblies for inflating the upper and lower cuffs. [Figure 55] FIG. 10 is a bottom side perspective view of another cervical support and reinforcement device according to the present invention, with the upper inner cuff shown in a deflated or neutral state. [Figure 56] FIG. 56 is a cross-sectional bottom side perspective view of the cervical support device of FIG. 55 taken below and perpendicular to the axial center of the upper inner cuff of the device. [Figure 57] FIG. 56 is a partial cross-sectional bottom side perspective view taken along line LVII-LVII of FIG. 55, with the internal components of the device intact to show the internal structure. DETAILED DESCRIPTION OF THE INVENTION

[0020] Referring now to the drawings and exemplary embodiments shown therein, various embodiments of a cervical support device for reducing or preventing preterm labor caused by cervical insufficiency (i.e., a shortened or dysfunctional cervix) are provided. The device is adjustable to apply a compressive force about the exterior of the cervix and can function to change the angle of the cervix, thereby promoting gestational age for the fetus in patients with cervical insufficiency. The device includes one or more expandable (e.g., inflatable) cuffs that, when expanded, apply a compressive force to the exterior of the cervix. The cuffs can be adjusted by the operator or user (e.g., a healthcare provider) without removing the device from inside the patient. In some instances where the cervix is ​​partially dilated to the point where the cervical mucus plug is shed, or in instances of PROM or PPROM, the device can be utilized to compress the cervix, thereby encouraging mucus plug regeneration, which can prevent infection from ascending the cervix and entering the uterus. The device can be utilized in a minimally invasive manner to provide support around the underside of the cervix to support the weight of the uterus and fetus, preferably with little or no irritation or inflammation to the cervix. In other words, the cuff can be left in a neutral or uninflated state. If the patient's cervix continues to shorten or dilate and minimally invasive techniques are not sufficient, the cuff can be inflated or further inflated to reduce the proximal opening diameter, thereby providing additional support to the external cervix and applying an external compressive force around the outer surface of the cervix in an attempt to prevent further opening or dilation. The terms "cuff" and "bladder" are used herein to refer to the expanding annular components of exemplary embodiments of the present disclosure, including, for example, a "proximal cuff," a "distal cuff," and an "inflatable bladder." Optionally, the cuff (either proximal or distal) may be continuous around the circumference of the device, may be intermittently spaced around the circumference of the device, may expand to define a non-circular or non-uniform opening, and / or may be expandable in both a transverse (e.g., radial) and oblique (e.g., non-radial) direction.It will be appreciated that the cervical support device may be utilized to support the cervix, uterus, and fetus even when the cuff is in a neutral or uninflated state.

[0021] With reference to the exemplary embodiment of FIGS. 1-6, a cervical support and reinforcement device 100 for reducing or preventing preterm labor is provided. Device 100 includes a flexible, hemispheroidal or hemispherical body 102 having an internal passageway with an upper or proximal opening 104 in an upper portion of body 102 and a lower or distal opening 106 in a lower portion of body 102 ( FIGS. 5 and 6 ). In the exemplary embodiment, proximal opening 104 is smaller in diameter than distal opening 106 and is dimensioned to receive and surround a lower, outer surface portion of a patient's cervix 101 when the device is positioned in the patient's vagina 103 immediately adjacent the base of the cervix ( FIGS. 1 and 2 ). For reference, FIGS. 16-18 provide sequential views of the interaction between a cervical support device 400 (similar to cervical support device 100 of FIGS. 1-6 ) and a patient's cervix 101 as the device is positioned and engaged with the cervix. The periphery of the lower portion of body 102 is dimensioned to engage or interact with the patient's inner vaginal wall (see FIGS. 1 and 2). In other words, the periphery of body 102 at distal opening 106 engages the vaginal wall to secure or support device 100 in sufficient proximity to cervix 101.

[0022] An upper or proximal cuff or bladder 108 is provided around the periphery of the proximal opening 104. The upper cuff 108 is expandable, e.g., inflatable with a fluid such as saline or air, to clamp or circumscribe the outer surface of the lower portion of the cervix 101. The proximal cuff 108 is shown in a normal, neutral, or deflated state in FIGS. 3 and 5 and in an expanded or inflated state in FIGS. 4 and 6, with a portion of the cuff 108 expanded toward the center of the proximal opening 104. In the inflated state, the proximal cuff 108 penetrates or impinges on the outer surface 101 of the cervix, thereby exerting an external force or pressure on the cervix, which can help keep the cervical opening or OS sufficiently closed and allow the fetus to remain in the uterus for a longer period of time. The area of ​​the proximal opening 104 is significantly reduced when the proximal cuff 108 is inflated. To emphasize the relative expansion of the proximal cuff 108 from its neutral state in Figures 3 and 5 to its expanded state in Figures 4 and 6, a pair of imaginary lines is provided between the series of Figures 3 and 4 and between the series of Figures 5 and 6. In an exemplary embodiment, the proximal cuff 108 is coupled to the proximal end of the wall of the body 102, such as in the form of a tongue and groove or dovetail mating configuration. However, it will be understood that the cuff 108 may be integrally formed with the wall of the body 102, such as by a one-piece molding process or an overmolding process.

[0023] As best shown in FIGS. 3 and 4 , the proximal cuff 108 includes two recesses 110 on opposite sides of the proximal opening 104 and two enlarged portions 112 on other opposite sides of the proximal opening 104 formed between the recesses 110. In the neutral state, the proximal cuff 108 defines a generally circular shape ( FIG. 1 ). As the proximal cuff 108 expands, the enlarged portions 112 expand toward the axial center of the proximal opening 104, while the recesses 110 remain substantially stationary, unchanged, or unexpanded. Thus, in the expanded state, the recesses 110 and the enlarged portions 112 cooperate to form a non-circular inner circumference of the proximal cuff 108 ( FIG. 5 ). When the proximal cuff 108 is in the expanded state, the area of ​​the proximal opening 104 is reduced compared to its area when the proximal cuff 108 is in the neutral state. The recess 110 is positioned to receive the portion of the cervix 101 that contains the major blood vessels that supply blood to the end of the cervix, and thus the recess 110 allows blood to flow into the underlying tissues of the cervix extending through the proximal opening 104 while the proximal cuff 108 is expanded and applies a compressive force to the cervix.

[0024] 5 and 6 , as the proximal cuff 108 expands, it expands radially inward toward the center of the proximal opening 104 and downward relative to the cross-section of the proximal opening 104. In other words, when the proximal cuff 108 expands with the device 100 positioned within the vagina immediately adjacent to the cervix 101, it clamps against the outer surface of the cervix while exerting a downward force on the cervix (i.e., away from the uterus 105). The downward angle of expansion of the proximal cuff 108, due to displacement caused by the increasing volume of the cuff during expansion or due to the cervix continuing to shorten over time, can act to pull or push the cervix 101 downward, away from the uterus 105, mitigating or preventing the cervix from slipping through the cuff. In other words, the combination of lateral and downward clamping forces can more effectively engage and restrain the outer surface of the cervix 101 compared to when clamping forces are applied only in the lateral direction. The angle of expansion of the proximal cuff 108 away from the transverse plane of the proximal opening 104 can be selected from a range between approximately one-half degree (0.5°) and eighty-nine-five degrees (89.5°).

[0025] It will be understood that the entire proximal cuff 108 may be formed of the same material (e.g., flexible silicone), different portions 110 and 112 of the cuff 108 may be formed of different materials (e.g., a flexible silicone extension portion 112 and a medical-grade plastic recess 110), and / or different portions 110 and 112 of the cuff 108 may be formed of materials of different compositions (e.g., a flexible silicone extension portion 112 and a semi-rigid silicone recess 110 having a higher durometer than the silicone of the extension portion 112).

[0026] Device 100 includes a raised annular rim, ridge, or lip 114 on the upper portion of body 102 that extends upwardly above or from proximal cuff 108 (i.e., toward uterus 105 when the device is placed in a patient's vagina; see FIGS. 5 and 6 ). Annular rim 114 defines the uppermost or proximal-most edge of device 100 and comprises a sloped outer wall 114a that extends from the top of rim 114 toward the outer surface of body 102 (in the cuff's neutral state; see FIGS. 5 and 6 ) and a sloped inner wall 114b that extends from the top of rim 114 toward the inner circumference of proximal cuff 108. Sloped inner wall 114b facilitates entry of cervix 101 into proximal opening 104 by funneling or guiding the end of the cervix along the sloped inner wall during placement of the device in the vagina. The sloped inner wall 114b may be angled at about eighty degrees (80°) relative to the longitudinal axis of the device 100 while still providing some guidance to the cervix 101. Preferably, the angle of the sloped inner wall 114b is between about five degrees (5°) and about sixty degrees (60°). In some embodiments, the raised lip may extend about ten millimeters (10 mm) above the upper or proximal edge of the proximal cuff 108. Preferably, the rim 114 is between about one millimeter (1 mm) and about four millimeters (4 mm) above the upper or proximal edge of the proximal cuff 108.

[0027] As shown in FIGS. 5 and 6 , a fluid conduit 116 is provided through a wall 118 of the body 102. The conduit 116 is in fluid communication with the proximal cuff 108 to allow a care provider to inflate or deflate the cuff 108 as needed to provide sufficient support to the cervix 101. An inlet 120 is provided on an exterior portion of the body 102, and an inflation / deflation device may be removably coupled to the device 100 to inflate or deflate the cuff 108 without removing the device 100 from the patient's vagina. Optionally, a valve may be provided at or near the inlet 120 to regulate the flow of fluid into and out of the conduit 116. An exemplary valve system 826 is shown in FIGS. 29 and 30 , and an inflation / deflation device 827 (including a tube 828 and a valve 830) is shown in FIG. 32 , which are described in further detail below.

[0028] It will be appreciated that while in some of the illustrated embodiments the proximal cuff expands downward or away from the cross-plane of the proximal opening, other embodiments are contemplated in which the proximal cuff expands substantially along the cross-plane, as shown in the exemplary embodiments of similar cervical support devices 400 and 800 shown in Figures 14-18 and 29-30, respectively, and described in further detail below. For example, the proximal cuff 808 may be configured to expand purely radially and concentrically, as shown sequentially for device 800 in Figures 29 and 30.

[0029] 7 and 8, another cervical support and reinforcement device 200 for reducing or preventing preterm labor is provided. Device 200 is similar to device 100 described above, but includes several alternative and / or additional components and features. Similar to the components of device 100, device 200 includes a main body 202, a proximal opening 204, a distal opening 206, an expandable annular cuff 208, a raised annular rim 214, and a fluid conduit 216 within a body wall 220. Compared to device 100, cervical support device 200 includes a mechanical anchoring element in the form of a pair of annular ridges, cleats, or teeth 222 along the inner circumference of proximal cuff 208. Due to the use environment of device 200 within the vaginal canal and around the outer cervix, which each have a relatively low coefficient of friction due to the presence of bodily fluids (e.g., waste and mucus), the mechanical anchoring element can prevent device 200 from slipping off cervix 101. Mechanical anchor elements can also be provided to engage the vaginal wall 103. Thus, the ridges 222 are configured to provide a mechanical anchor element (see example arrangements in FIGS. 1 and 2 ) for gripping the outer surface 101 of the cervix to provide additional grip for holding the cervix in the elongated, closed state and to mitigate or prevent the cervix from slipping out of the proximal cuff 208. It is contemplated that multiple rows of cleats or ridges can be provided such that as the cuff expands, compressive forces directed toward the cervix are substantially concentrated at the edges of one or more of the ridges to ensure sufficient interaction between the cervix and the cuff. The additional rows of ridges can help prevent the cervix from slipping out of the cuff as the cuff expands, which may otherwise occur due to the low coefficient of friction of the cervical surface.

[0030] The ridges 222 may be continuous or uninterrupted around the entire inner circumference of the proximal cuff 208. However, it will be understood that the ridges 222 may be segmented and spaced apart along the inner circumference of the proximal cuff (see below for examples of segmented cleats for devices 1000 and 1100 in FIGS. 36-37 and 51-54). In embodiments with segmented ridges, the ends of each ridge segment may be chamfered for comfort and / or to concentrate more of the compressive forces from the cuff onto a smaller area of ​​the cervix 101. The height or depth of the ridges may be between approximately 0.1 millimeter (0.1 mm) and 10 millimeters (10 mm). Preferably, each ridge 222 is formed of a similar material to the proximal cuff 208 (e.g., flexible silicone) and may be integrally formed or molded with the cuff 208. However, it is contemplated that the ridge may be formed of a different material than the cuff, such as a hard polymer (e.g., polyetheretherketone (PEEK)), a silicone of a higher durometer than that used for the cuff, or a semi-flexible metal (e.g., 316L stainless steel). While forming the ridge with the cuff may be preferred for manufacturing and durability purposes, the ridge may also be formed separately from the cuff and then adhered to the cuff, such as by an overmolding process, bonding, or fastening with mechanical fasteners.

[0031] In various cervical support devices of the present disclosure, the proximal cuff can utilize various structural aspects to achieve downward expansion of the cuff relative to the cross-section of the proximal opening, as described in further detail below. For example, the cuff can be formed with a non-uniform wall thickness along its radial cross-section. Upon expansion, a cuff with a non-uniform wall thickness expands toward the thickest portion of its wall (see FIGS. 9-13, described in further detail below, particularly the exemplary cuffs shown in the sequence of FIGS. 12 and 13, which illustrate expansion of the cuff at the thickest portion of the cuff wall). In embodiments having a cuff that forms a non-circular proximal opening, for example, the expansion portion can utilize a non-uniform wall thickness, while the recessed portion can have a generally uniform wall thickness.

[0032] A cross-sectional view of an exemplary expandable cuff 300 is shown in FIG. 9 and is shown coupled to a proximal portion of a wall 302 of a cervical support device (such as device 100 or 200 described above). Cuff 300 includes a primary inflatable bladder or chamber 303 defined by upper and lower thin-walled sections 304 and a thicker or thicker-walled section 306 between the thin-walled sections 304 at the proximal portion of cuff 300. Upper and lower thin-walled sections 304 are generally parallel to each other and to the cross-section of the proximal opening formed by the cuff. In this configuration, due to the properties of flexible silicone, upon inflation of the cuff, thicker-walled section 306 expands more than thin-walled section 304, effectively expanding cuff 300 radially toward the center of the proximal opening and downwardly away from the cross-section of the proximal opening. During inflation, thin-walled portion 304 initially expands more rapidly than thick-walled portion 306 until they each reach maximum expansion, at which point thin-walled portion 304 no longer expands and the remaining expansion of cuff 350 occurs in thick-walled portion 306. Exemplary wall thicknesses of the cuff include thin-walled portion 304 ranging from approximately 0.102 millimeters (0.004 inches) to 0.508 millimeters (0.020 inches) thick, while thick-walled region 306 ranges from approximately 0.254 millimeters (0.010 inches) to 2.54 millimeters (0.100 inches) thick. It will be appreciated that the different portions, i.e., thin-walled portion 304 and thick-walled portion 306, may be formed of silicone having different durometers, which can further encourage expansion of cuff 300 in a desired direction.

[0033] Another exemplary expandable cuff 310 is shown in FIG. 10 and is shown coupled to a proximal portion of a wall 312 of a cervical support device (such as device 100 or 200 described above). Cuff 310 has a similar or substantially identical structure to exemplary cuff 300 and includes a main inflatable bladder or chamber 313, a thin-walled portion 314, and a thick-walled portion 316 that function substantially similarly to the corresponding aspects of cuff 300. In comparison to cuff 300 of FIG. 9, cuff 310 shown in FIG. 10 includes a pair of ridges, cleats, or teeth 318 that are similar in structure and function to ridges 222 described above for cervical support device 200 and shown in FIGS. 7 and 8. Cuff 310 also includes a pair of buckled wall segments 320 in each thin-walled portion 314 (FIG. 10). In a neutral, unexpanded state, the buckled wall segments 320 of the cuff 310 retain their buckled shape, as shown in FIG. 10 . When the cuff 310 is inflated, the buckled wall segments 320 unfold and flatten, thereby providing an initial expansion of the cuff 310 and allowing the cuff to expand radially toward the center of the proximal opening. Once the buckled wall segments 320 have substantially flattened, the remainder of the expansion of the cuff 310 may occur in the thicker wall portions 316. It will be appreciated that multiple buckled wall segments may be provided on the upper and / or lower portions of the cuff to allow the cuff to expand in a desired direction and / or with a desired displacement. Multiple buckled wall segments may allow for extended expansion of the cuff 310 without the cuff reaching its elastic deformation limit. It will also be appreciated that buckled wall segments may be provided only on the upper or lower portions of the cuff to allow the cuff to expand in a desired direction and / or with a desired displacement.

[0034] Another exemplary inflatable cuff 330 is shown in FIG. 11 and is shown coupled to a proximal portion of a wall 332 of a cervical support device (such as device 100 or 200 described above). Cuff 330 has a similar or substantially identical structure to exemplary cuffs 300 and 310, including a main inflatable bladder or chamber 333, a thin-walled portion 334, and a thick-walled portion 336 that function substantially similarly to the corresponding aspects of cuffs 300 and 310. Compared to cuff 300 of FIG. 9, cuff 330 includes a pair of buckled wall segments 340a and 340b in each thin-walled portion 334 (FIG. 11). Compared to cuff 310 of FIG. 10, cuff 330 shown in FIG. 11 does not include ridges, cleats, or teeth. Cuff 330 also includes a larger buckled wall segment 340a in upper thin-walled portion 334 and a smaller buckled wall segment 340b in lower thin-walled portion 334. In a natural, unexpanded state, buckled wall segments 340a and 340b of cuff 330 retain their buckled shape, as shown in FIG. 11 . When cuff 330 is inflated, buckled wall segments 340a and 340b spread out and flatten. Because segment 340a is larger than segment 340b, it can spread out to a greater length than segment 340b, thus allowing cuff 330 to expand radially toward the center of the proximal opening and downwardly away from the cross-section of the proximal opening.

[0035] Yet another exemplary inflatable cuff 350 is shown in FIGS. 12 and 13 and is shown coupled to a proximal portion of a wall 352 of a cervical support device (such as device 100 or 200 described above). Cuff 350 has a similar or substantially identical structure to exemplary cuffs 300 and 310, including a main inflatable bladder or chamber 353, a thin-walled portion 354, a thick-walled portion 356, and a pair of ridges, cleats, or teeth 358 that function substantially similarly to the corresponding aspects of cuffs 300 and 310, respectively. Compared to cuff 310 of FIG. 10, cuff 350 shown in FIGS. 12 and 13 does not include a buckled wall segment. Compared to cuff 300 of FIG. 9, cuff 350 includes a pair of inflatable bladders or chambers 360 and 362 (FIGS. 12 and 13) in addition to main inflatable chamber 353. The pair of chambers 360 and 362 are adjacent to and substantially coaxial with each other and the main chamber 353. In the exemplary embodiment, the chambers 360 and 362 are defined as elongated trapezoids with elongated side walls 360a and 362a and upper walls 360b and 362b that are longer than bottom walls 360c and 362c. In the natural, unexpanded state, the longer upper walls 360b and 362b position the cuff 350 at an angle that points initially downward to encourage downward expansion of the cuff relative to the cross-section of the proximal opening. When the cuff 350 is inflated, the pair of chambers 360 and 362 can expand somewhat toward the axial center of the proximal opening or can remain substantially unchanged or unexpanded. During inflation, the main chamber 353 expands radially inward toward the axial center of the proximal opening and downward relative to the cross-section of the proximal opening. The relative radial and downward movement of inflated cuff 350 can be seen in succession in Figures 12 and 13 and with reference to the phantom lines therebetween. Chambers 353, 360, and 362 may be in fluid communication with one another such that any inflation of cuff 350 inflates all three chambers together, or each chamber may be individually sealed and fluidly connected to a dedicated fluid conduit such that the chambers are individually accessible (e.g., inflatable or deflated) by the provider.

[0036] Similar cuffs are contemplated that are similar to that of expandable cuff 350 described above and shown in FIGS. 12 and 13, but instead of the long walls of the additional chambers being adjacent to each other at their respective upper walls 360b and 362b as shown in FIGS. 12 and 13, the longer walls are offset such that one chamber has a long upper wall 360b and a short lower wall 360c similar to those shown in FIGS. 12 and 13, and an adjacent chamber has a short upper wall and a long lower wall. In such an embodiment, when the chambers of the cuff are inflated, the two adjacent upper and lower walls of the additional chambers may extend in a manner similar to a sine wave. This may allow a care provider to make slight adjustments to the angle of the expanded cuff to adjust and fine-tune the direction of the compressive force applied about the cervix, or may allow the provider to reposition the cervix within the cuff. In yet another possible embodiment, one of the additional chambers may have upper and lower wall lengths that are equal, while the second additional chamber has upper and lower wall lengths that are unequal, such that the first chamber expands substantially radially toward the axial center of the proximal opening and the second cuff expands radially inward toward the axial center of the proximal opening and downward relative to the cross-section of the proximal opening (e.g., trapezoidal chambers 360 and 362, as shown in Figures 12 and 13).

[0037] 14-18, another cervical support and reinforcement device 400 for reducing or preventing preterm labor is provided. Device 400 is similar to devices 100 and 200 described above, but includes several alternative and / or additional components and features. Similar to the components of devices 100 and 200, device 400 includes a main body 402, a proximal opening 404, a distal opening 406, and an inflatable annular cuff 408 (see example arrangements in FIGS. 1 and 2). Proximal cuff 408 is similar to cuff 350 described above and shown in FIGS. 12 and 13 in that cuff 408 includes multiple inflatable bladders or chambers 410 and 412, except that instead of being arranged side-by-side as in bladders 360 and 362, an upper first bladder 410 is positioned above a lower second bladder 412. Bladders 410 and 412 are integrally formed (e.g., overmolded) into or unitarily formed with an upper or proximal portion of wall 402 of device 400. Figure 14 shows device 400 with both cuff bladders 410 and 412 in a neutral or deflated state, and Figure 15 shows device 400 with both cuff bladders 410 and 412 in an inflated or expanded state.

[0038] Bladders 410 and 412 may be individually accessible and are configured such that when upper bladder 410 is independently inflated, cuff 408 expands in a generally upward manner (i.e., toward uterus 105), and when lower bladder 412 is independently inflated, the cuff expands generally radially inward toward the axial center of proximal opening 404. Thus, the independent bladders 410 and 412 of cuff 408 may allow a care provider to fine-tune or adjust positional aspects of device 400 without having to manually adjust the device position within the vagina and without risking potential further irritation to cervix 101 or vagina 103. For example, when the device 400 is placed within the vagina 103 and the lower portion of the device engages the ligaments and muscles of the vaginal wall (see example placements in FIGS. 1 and 2 ), the upper chamber 410 is first inflated or expanded to apply a force to the cervix 101 that is perpendicular to the cross-section of the proximal opening 404, or in other words, a force that is directed substantially upward toward the uterus 105, which can serve to displace more of the cervical tissue, thereby urging it toward the proximal opening 404. Once the cervix 101 is sufficiently embedded within the proximal opening 404, the provider can inflate the second lower chamber 412 to apply a clamping compressive force around the cervix. Annular ridges, teeth, or cleats 414 ( FIGS. 14 and 15 ) are provided on the inner circumference of the proximal cuff 408 such that as the lower bladder 412 expands, the ridges 414 penetrate and engage the outer surface 101 of the cervix (see FIG. 18 ). It is contemplated that the peripheral walls of bladders 410 and 412 may include expansion elements formed therein to impart or encourage a desired direction of expansion for each bladder. For example, the periphery of bladders 410 and 412 may include expansion elements in the form of one or more buckled or folded walls or wall segments (similar to buckled wall portions 320 and 340a and 340b shown in FIGS. 10 and 11, respectively) that, upon expansion of each bladder, bias the expansion of each bladder in a desired direction (e.g., upward toward uterus 105 or radially toward the axial center of proximal opening 404).As another example, certain portions of the bladder walls may include perforations that bias the expansion of each bladder toward a desired direction upon expansion of the respective bladder.

[0039] 19 and 20, another cervical support and reinforcement device 500 for reducing or preventing preterm labor is provided. Device 500 is similar to devices 100, 200, and 400 described above, but includes several alternative and / or additional components and features, with more significant differences described below. Similar to the components of devices 100, 200, and 400, device 500 includes a main body 502, a proximal opening 504, a distal opening 506, an expandable annular cuff 508 immediately adjacent the proximal opening, a recess in proximal cuff 508, an enlarged portion of proximal cuff 510, and a fluid conduit 516 (see example arrangements in FIGS. 1 and 2).

[0040] Another or second expandable annular cuff 518 is provided proximate the distal opening 506 and / or the outer wall of the device 500 (FIGS. 19 and 20). The cuff 518, hereafter referred to as the distal cuff 518, is provided to expand into and engage the wall of the vagina 103 to provide additional grip or support to hold the device 500 in a desired position adjacent the cervix 101. It will be appreciated that distal cuff 518 can include similar structure and functionality to cuffs 108, 208, 300, 310, 330, 350, and / or 408 described above, such as, for example, buckled wall portions 320, 304a, or 340b (FIGS. 10 and 11), non-uniform wall thickness as shown in expandable cuffs 300, 310, 330, and 350 (FIGS. 9-13), and / or two or more bladders as shown in expandable cuff 350 (FIGS. 12 and 13), and expandable cuff 408 (FIGS. 14-18). FIG. 19 illustrates device 500 with proximal cuff 508 and distal cuff 518, respectively, in a neutral or uninflated state, and FIG. 20 illustrates device 500 with proximal cuff 508 in a neutral or uninflated state and distal cuff 518 in an inflated or expanded state. During inflation, the distal cuff 518 expands outward, away from the axial center of the distal opening 506 and therefore toward the vaginal wall 103. The outward expansion of the distal cuff 518 is shown in the sequence of Figures 19 and 20, with phantom lines added to more clearly illustrate the relative movement of the cuff 518 in its expanded state shown in Figure 20 relative to its neutral state shown in Figure 19.

[0041] An exemplary expandable cuff system or device 600 is shown in FIGS. 21 and 22 and is coupled to the distal portion and / or outer surface of a wall 602 of a cervical support and reinforcement device (such as devices 100, 200, 400, or 500 described above). Cuff system 600 comprises a pair of inflatable annular bladders or chambers including a first or radial bladder 604 and a second or lateral bladder 606. Radial bladder 604 is disposed around the periphery of the distal portion of wall 602, and lateral bladder 606 is disposed along the distal end of wall 602. Upon inflation, radial bladder 604 expands outward, away from the axial center of a distal opening 608 of the device, to provide additional grip or support along the vaginal wall. Upon inflation, lateral bladder 606 expands downward, away from the distal end of wall 602. In other words, the lateral bladders 606 expand in opposite directions to the uterus. To more clearly illustrate the relative expansion of the lateral bladders 606 from their neutral state in FIG. 21 to their expanded state in FIG. 22, phantom lines are provided between the successive FIGS. 21 and 22. In their expanded state, the lateral bladders 606 provide an increase in the overall height of the device 600, which may allow the provider to further engage the proximal cuffs at the upper or proximal end of the wall 602 with the cervix 101 and / or provide additional support to the fundus of the cervix 101 and uterus 105.

[0042] It will be understood that either or both radial bladder 604 or lateral bladder 606 can include similar structure and functionality to cuffs 108, 208, 300, 310, 330, 350, 408, 508, and / or 518 described above, such as, for example, buckled wall portions 320, 304a, or 340b (FIGS. 10 and 11), non-uniform wall thickness as shown in expandable cuffs 300, 310, 330, and 350 (FIGS. 9-13), and / or two or more smaller bladders as shown in expandable cuffs 350 and 408 (FIGS. 12-13 and 14-18, respectively). While cuff system 600 is shown as having two bladders 604 and 606, it will be understood that a single bladder or chamber can provide sufficient vaginal wall engagement while also increasing the overall height of device 600. For example, expansion elements may be provided along particular walls of a single bladder to provide the desired directional expansion. It is contemplated that device 600 (as well as any of the above-described or below-described embodiments of the cervical support device) may be placed on a patient in an inverted manner, with the distal end facing and engaging the cervix 101, to support the cervix and uterus 105. In the inverted orientation, the distal cuff of the device can be placed in contact with the upper vaginal wall and fornix region (i.e., the upper portion of the vagina extending into the depression created between the vaginal wall and the outer surface of the lower portion of the cervix) so that, as the distal cuff expands, it can provide support to the uterus 105 in a location where prolapse typically occurs. In embodiments in which the distal cuff expands laterally, the distal cuff distributes the weight of the uterus 105 over a larger surface area along the vaginal wall (relative to a device oriented in the standard direction with the proximal cuff toward the uterus), which may reduce the risk of complications such as pressure sores and / or necrosis. In embodiments in which the distal cuff expands both laterally (e.g., toward the uterus 105) and away from the main device body, the distal cuff can distribute the weight of the uterus 105 over a larger surface area while providing upward support to the uterus (which can be customized as needed).

[0043] 23 and 24 illustrate another exemplary cervical support and reinforcement device 700 that is similar to or substantially identical to the cervical support device 100 described above and shown in FIGS. 1-6. The device 700 includes inner and outer relief notches 722a and 722b formed in the inner and outer surface portions of the wall 718. The notches 722a and 722b extend substantially between the distal end of the wall and the proximal cuff 708. The notches 722a and 722b provide increased flexibility to the wall 718, which can facilitate folding or collapsing of the device 700 to aid in insertion of the device into the patient's vagina. For example, a provider may be able to fold the device so that it forms a leading edge or tip with a reduced cross-sectional area to more easily protrude through the vaginal opening. In addition to aiding insertion, the notches 722a and 722b can also provide a visual indication of which side is intended to be inserted into the patient first.

[0044] 25-33, another cervical support and reinforcement device 800 for reducing or preventing preterm labor is provided. Device 800 is similar to devices 100, 200, 400, 500, and 700 described above, but includes several alternative and / or additional components and features, with more significant differences described below. Similar to the components of devices 100, 200, 400, 500, and 700, device 800 includes, for example (see example arrangements in FIGS. 1 and 2), a main body 802, a proximal opening 804, a distal opening 806, an expandable annular cuff 808 immediately adjacent proximal opening 804, and a fluid conduit 816 (FIGS. 29 and 30). Similar to the components of device 500, and as best shown in FIG. 28, proximal cuff 808 of device 800 includes a recess 810 and an enlarged portion 812. However, instead of two respective sets of recesses and extensions, proximal cuff 808 includes a set of three recesses 810 and a set of three extensions 812, which are evenly distributed around the proximal portion of body 802 and define proximal opening 804. Also similar to the components of device 500, device 800 includes an expandable annular cuff or cuff system 818 immediately proximal to distal opening 806, with distal cuff 818 operable to expand downwardly, away from the distal end of the wall and away from uterus 105. Distal cuff 818 includes three segments of inflatable bladders 818a equally spaced around the circumference of the distal end of body 802 (FIGS. 25-31). However, it will be understood that distal cuff 818 may include more or fewer bladder segments, or distal cuff 818 may be formed of a single, continuous, uninterrupted bladder. FIG. 29 shows the device 800 with the proximal cuff 808 and the distal cuff 818 each in a neutral or uninflated state, FIG. 30 shows the device 800 with the proximal cuff 808 in an inflated or expanded state and the distal cuff 818 in a neutral or uninflated state, and FIG. 31 shows the device 800 with the proximal cuff 808 and the distal cuff 818 each in an inflated or expanded state.An example of selective inflation of bladders 818a is shown in FIG. 33, where one of the bladders 818a of distal cuff 818 is inflated more than the other two bladders 818a.

[0045] During inflation, the proximal cuff 808 expands substantially inwardly toward the axial center of the proximal opening 804. The inward expansion of the proximal cuff 808 is shown in the sequence of FIGS. 29 and 30, with phantom lines added to more clearly illustrate the relative movement of the cuff 808 in its expanded state shown in FIG. 30 relative to its neutral state shown in FIG. 29. During inflation, the distal cuff 818 expands partially inwardly toward the axial center of the distal opening 806 and partially outwardly away from the axial center of the distal opening 806, and thus toward the vaginal wall 103. The inward and outward expansion of the distal cuff 818 is shown in the sequence of FIGS. 30 and 31, with phantom lines added to more clearly illustrate the relative movement of the cuff 818 in its expanded state shown in FIG. 31 relative to its neutral state shown in FIG. 30.

[0046] A lumen ring 822 (best shown in FIGS. 26, 27, 29, and 30) is provided between the distal end of the main body 802 and the distal cuff 818 and is fluidly connected to the inlet 820 ( FIG. 27 ) of the fluid conduit 816. The lumen ring 822 includes open channels 824 on the proximal side of the ring. Preferably, each channel 824 includes at least two dedicated ports 827 that are open to atmosphere ( FIG. 32A ). When the device 800 is fully assembled, the channels 824 form a closed lumen on the proximal side of the ring 822. The distal cuff is fitted to the bottom distal side of the lumen ring 822, with one of the open ports 827 of each channel 824 opening to one of the inflatable segments 818 a of the distal cuff. Optionally, a check valve mechanism device may be provided, such as in fluid connection with fluid inlet 820, one of channels 824, and / or open port 827. Individual bladders 818a may each be ported to a single lumen, and the other end of the lumen may be ported to a check valve for independently controlling the inflation and deflation of each bladder 818a. An inflation device, e.g., a tube, may be connected or coupled to the check valve to introduce fluid (e.g., air or saline) into the various expandable cuff elements to fill or inflate the cuff, as needed, thereby properly fitting and securing the device within the patient's vagina 103 to support the cervix 101. For example, a multi-lumen tube 828 ( FIG. 32 ) having a one-way valve, such as a duckbill check valve 830, may be provided to engage open port 827 for inflating the cuff components. Preferably, each lumen of tube 828 is individually accessible so that a care provider can direct the inflation of only one or a selected subset of the cuff components at a time (see FIG. 33 ) to fine-tune the clamping force exerted around cervix 101, along with the positioning of device 800. The ability to manipulate each of bladders 808 and 818a may allow a care provider to redirect or angle cervix 101 in a specific manner to relieve pressure and stabilize cervix 101. For example, a provider can change the orientation of device 800 by selectively inflating one or more of distal cuff bladders 818a.A lumen within tube 828 may provide a passageway for items to be delivered to device 800, for example, nitinol wire, springs, electrical wiring, or medicines / drugs could be passed through tube 828 and into device 800. Tube 828 may be removably coupled to device 800, which may provide easier movement for the patient, or tube 828 may be permanently joined to the device, with the tube remaining inside the patient and / or extending to the exterior of vagina 103.

[0047] 34, proximal cuff 808 includes a variable wall thickness, with upper and lower thin-walled sections 832 and a thicker or thicker-walled section 834 in the proximal portion of cuff 808 between upper and lower thin-walled sections 832. Proximal cuff 808 is coupled to the proximal end of the wall of body 802 with teeth 836 that engage grooves 838 formed in the proximal end of the wall. Thin-walled section 832 and thick-walled section 834 function similarly to sections 304 and 306 of cuff 300 shown in FIG. 9 and described above.

[0048] Referring now to FIG. 35 , another cervical support and reinforcement device 900 for reducing or preventing preterm labor is provided. Device 900 is similar to devices 100, 200, 400, 500, 700, and 900 described above, but includes several alternative and / or additional components and features, with more significant differences described below. Similar to the components of devices 100, 200, 400, 500, 700, and 800, device 900 includes a main body 902, a proximal opening 904, a distal opening, an expandable annular cuff 908 immediately adjacent to the proximal opening 904, and an expandable annular cuff 918 immediately adjacent to the distal opening, e.g., two or more inflatable bladders 918a defining distal cuff 918 ( FIG. 35 ) (see example arrangements in FIGS. 1 and 2 ). Main body 902 of device 900 is asymmetrical, i.e., not circular or spherical. For example, the main body 902 includes three flared sections with larger radii and three smaller sections between the flared sections. The flared sections may provide improved engagement with the vaginal walls to inhibit, limit, or inhibit rotation of the device 900 inside the vagina 103.

[0049] 36 and 37 , another cervical support and reinforcement device 1000 for reducing or preventing preterm labor is provided. Device 1000 is similar to devices 100 and 200 described above and shown in FIGS. 1-6 and 7-8 , but includes several alternative and / or additional components and features. Similar to the components of devices 100 and 200, device 1000 of FIGS. 36-37 includes a main body 1002, a proximal opening 1004, a distal opening 1006, an expandable annular cuff 1008 having a recess 1010 and an enlarged portion 1012, and a raised annular rim 1014. In comparison to devices 100 and 200, cervical support device 1000 includes an array of a number of ridges, cleats, or teeth 1016 arranged in a spaced-apart configuration along the inner circumference of the enlarged portion 1012 of proximal cuff 1008. The cleats 1016 are configured to grip the outer surface 101 of the cervix (see example arrangements in FIGS. 1 and 2 ) to provide additional grip to hold the cervix in the elongated closed state and to mitigate or prevent the cervix from slipping out of the proximal cuff 1008. The cleats 1016 may be formed with the outer wall of the cuff 1008, such as by an extrusion, molding, or overmolding process. It is contemplated that the wall thickness of the cuff 1008 at or adjacent to each cleat 1016 may be modified to allow the cleats 1016 to splay outward relative to the cuff wall such that the cleats 1016 lie higher from the cuff wall when the cuff 1008 is in an inflated state compared to when the cuff 1008 is in a neutral state.

[0050] 38-42 show various exemplary shapes in which the radial profile of the cleat 1016 may be formed. For reference, the phantom arrows beside each of the exemplary cleat profiles 1016a-1016e in FIGS. 38-42 indicate a direction toward the bottom of the cervical support device, which is therefore a direction toward the bottom of the cervix 101 when the device is positioned with the cuff 1008 encircling the cervix. In some embodiments, the cleat height (i.e., the distance the cleat rises from the cuff wall) may range, for example, between about one hundred micrometers (100 μm) and one thousand five hundred micrometers (1500 μm). The cleat width (i.e., the length from top to bottom of the cleat) may range, for example, between about one hundred micrometers (100 μm) and one thousand five hundred micrometers (1500 μm). The various forms of cleat profiles 1016a-1016e in Figures 38-42 may be molded or formed from the same material as the cuff 1008, or the cleats may be formed from a different material or material of different hardness, such as a silicone or plastic that is more rigid than the silicone of the cuff 1008. For manufacturing purposes, it may be more preferable for the cleats to be formed from the same resilient material as the cuff 1008. It is contemplated that the cleats 1016 may be individually configured to act or function as suction cups to form a vacuum engagement with the tissue of the exterior surface of the cervix 101. As shown in Figures 38-42, cleat profiles 1016a, 1016b, 1016c, 1016d, and 1016e are shown as solid bodies. However, it will be appreciated that the cleat may be formed with a gap between its perimeter and the cuff wall, or with a gap that is open into the cuff 1008 so that when the cuff is inflated, the gap in the cleat may expand or dilate to expand the cleat. As shown in FIG. 42, cleat 1016e may be formed such that the downward edge / tip 1017 forms an acute angle with the outer wall of the cuff 1008. This configuration may effectively act as a hook to grasp and hold cervical tissue, thus providing improved engagement with the cervical tissue.

[0051] 43-50 show various exemplary shapes in which the front elevational profile of cleat 1016 may be formed. For reference, the phantom arrows provided on each of exemplary cleat shapes 1016f-1016m indicate a direction toward the bottom of the cervical support device, and thus, toward the bottom of cervix 101 when the device is positioned with cuff 1008 surrounding the cervix. Any of cleat shapes 1016f-1016m (in addition to other suitable cleat shapes) may be utilized with any of cleat profiles 1016a-1016e (in addition to other suitable cleat profiles) to form a desired cleat 1016 for engaging cervix 101. Cleat shape 1016f shown in FIG. 43 is circular and may have a diameter ranging, for example, between approximately fifty micrometers (50 μm) and two thousand micrometers (2000 μm). 44-49 show non-circular cleat shapes 1016g-1016l, which may have overall height and width dimensions ranging, for example, between twenty-five micrometers (25 μm) and two-five hundred micrometers (2500 μm). FIGS. 49 and 50 show additional geometric cleat shapes 1016l and 1016m, respectively, extending outward from the cuff wall 1008 to pointed ends or tips 1019 and 1021, respectively. Cleat shape 1016l in FIG. 49 is generally pyramidal in shape, and in the illustrated embodiment, is an oblique pyramid with tip 1019 offset toward its underside. Cleat shape 1016m is generally conical in shape, and in the illustrated embodiment, is an oblique cone with tip 1019 offset toward its underside.

[0052] 51-54, another cervical support and reinforcement device 1100 for reducing or preventing preterm labor is provided. Device 1100 is similar to devices 100, 500, and 1000 described above and shown in FIGS. 1-6, 19-20, and 36-37, but includes several alternative and / or additional components and features. Similar to the components of devices 100, 500, and 1000 described above, device 1100 of FIGS. 51-54 includes a main body 1102, a proximal opening 1104, a distal opening 1106, an expandable annular proximal cuff 1108 having a recess 1110 and an enlarged portion 1112, and a raised annular rim 1114. In further similarity to components of device 500, device 1100 includes an expandable second annular cuff 1118 proximate the distal opening 1106 and / or the outer surface of body 1102. Second cuff 1118 is hereinafter referred to as the “distal cuff” 1118. In further similarity to components of device 1000, device 1100 includes an array of cleats of teeth 1116 arranged in a spaced apart configuration about the inner circumference of enlarged portion 1112 of proximal cuff 1108. Compared to device 500, distal cuff 1118 of cervical support device 1100 is relatively larger than cuff 518 and extends further up the wall of body 1102 of device 1100 than does cuff 518. Exemplary embodiments of cuff 1118 may extend, for example, over half of the outer wall of body 1102 or along substantially the entire length of the outer wall of body 1102. The increased size increases the contact area between the cuff 1118 and the vaginal wall 103, providing improved support to the cervix 101 and / or uterus 105. It will be appreciated that the distal cuff 1108 may be formed with a single bladder or two or more bladders similar to the bladder 818a of the distal cuff 818 described above and shown in FIGS. 25-31. Additionally, compared to device 1000, the cleats 1116 of the cervical support device 1100 are significantly larger than the cleats 1016 of device 1000, and fewer cleats 1116 are provided around the inner circumference of the enlarged portion 1112.Cleats 1116, similar to cleats 1016, are configured to grip the outer surface 101 of the cervix (see example arrangements in FIGS. 1 and 2 ) to provide additional grip to hold the cervix in the elongated, closed state and to mitigate or prevent the cervix from slipping out of the proximal cuff 1108. The cleats 1116 may be formed with the outer wall of the cuff 1108, such as by an extrusion, molding, or overmolding process. It is contemplated that the wall thickness of the cuff 1108 at or adjacent to each cleat 1116 may be modified to allow the cleats 1116 to splay outward relative to the cuff wall such that the cleats 1116 lie higher from the cuff wall when the cuff 1108 is in an inflated state compared to when the cuff 1108 is in a neutral state.

[0053] Similar to the tooth 836 and groove 838 configuration of the proximal cuff 808 and the wall of the body 802 of the device 800 described above and shown in FIGS. 25-31 , the proximal cuff 1108 of the device 1100 is coupled to the proximal end of the wall of the body 1102 with teeth 1136 that engage grooves 1138 formed in the proximal end of the wall ( FIGS. 52-54 ). The distal cuff 1118 of the device 1100 is coupled to the distal end of the wall of the body 1102 (e.g., at the distal-most portion of the outer surface of the wall) at one end and to a central outer surface portion of the wall of the body 1102 at the opposite end. Each end of the distal cuff 1118 is coupled to the body 1102 with teeth 1140 that engage corresponding grooves 1142 formed in the wall of the body 1102.

[0054] Device 1100 includes fluid conduits 1144 and 1146 in fluid communication with proximal cuff 1108 and distal cuff 1118, respectively (FIG. 54). Fluid conduits 1144 and 1146 are similar in structure and function to conduits 116, 216, 516, and 816 of respective devices 100, 200, 500, and 800 (FIGS. 5 and 6, 7 and 8, 19 and 20, and 29 and 30, respectively). As shown in FIG. 54, conduits 1144 and 1146 are dedicated to the corresponding cuffs 1108 and 1118 and extend from the body 1102 of device 1100 to the interior of a tube 1148 that extends from the body 1102 toward the interior of device 1100. A valve system 1150, similar in function to valve system 826 described above and shown in FIGS. 29-30 , is provided at the distal end of tube 1148 to provide valves 1152 and 1154, such as one-way duckbill valves, for each of conduits 1144 and 1146. Tube 1148 may be long enough to extend out from the device through the vaginal opening (when positioned within the patient's vagina), allowing a care provider to easily access valve system 1150 without removing or repositioning the device within the patient. An advantage of having the valves exposed on the exterior of the vaginal opening is that a care provider can easily break the pressure seal to relieve pressure within conduits 1144 and 1146 and cuffs 1108 and 1118 that would otherwise be trapped by the function of one-way valves 1152 and 1154. For example, a commonly known or commercially available device, such as a locking needle or syringe tip coupled to tube 1148, may be utilized to allow a care provider to easily break the pressure seal. A caregiver can break the pressure seal by removing the valve system 1150 from the tube 1148 .

[0055] 55-57, another cervical support and reinforcement device 1200 for reducing or preventing preterm labor is provided. Device 1200 is similar to device 1100 described above and shown in FIGS. 51-54, but includes several alternative and / or additional components and features. Similar to the components of device 1200 described above, device 1200 of FIGS. 55-57 includes a main body 1202, a proximal opening 1204, a distal opening 1206, an expandable annular proximal cuff 1208 having a recess 1210, an array of cleats or teeth 1216 disposed in a spaced apart configuration around the inner circumference of enlarged portion 1212 of proximal cuff 1208, and teeth 1236 that engage grooves 1238 formed in the proximal end of the wall (FIG. 57). Unlike device 1100, device 1200 does not include an expandable annular distal or external cuff, although it will be appreciated that a distal or external cuff may be provided with device 1200 if desired.

[0056] A fluid reservoir 1240 is formed within the wall of the body 1202 and is in fluid communication with the cuff 1208 (FIGS. 56 and 57). The device 1200 includes a valve system having an inlet port 1241 (FIG. 55). The inlet port 1241 may be formed as a one-way valve, for example, as described above for devices 800 and 1100. The device 1200 includes a component cavity 1242 formed within another portion of the wall of the body 1202 adjacent to the fluid reservoir 1240 (FIG. 56). The component cavity 1242 is provided to house an internal fluid pump 1244 disposed within the wall of the body 1202 and in fluid communication with the fluid reservoir 1240 via a first conduit 1246 and with the cuff 1208 via a second conduit 1248 (FIG. 57). The pump 1244 is operable to move fluid from the reservoir 1240 to one or more portions of the cuff 1208 to inflate and / or deflate the cuff. The inlet port 1241 may be configured as a vent to allow the transfer of air to offset a vacuum created during operation of the pump 1244.

[0057] A controller or computer 1250 is electronically coupled to the pump 1244 to control its operation. A power source in the form of a rechargeable battery 1252 is coupled to the pump 1244 and the controller 1250. The controller 1250 may be wireless communication / control enabled to allow a care provider to remotely inflate / deflate the cuff 1208 without any invasive procedures to access the device 1200, thus allowing the cervical support device 1200 to be a closed system and eliminating the need for physical manipulation to adjust the device. For example, the controller may include Bluetooth® wireless communication or other remote control devices. A charging cable may be provided for charging the battery 1252, either internal or external to the patient. A pressure transducer 1254 is coupled to the controller 1250 to provide the care provider with information regarding the status of the device 1200, such as the inflation / deflation status of the cuff 1208 and the force exerted on the cervix 101 or vagina 103. In some embodiments, the pressure transducer 1254 may be adapted to detect a pressure drop within an acceptable range (as set by a care provider), and the pump 1244 may be configured to automatically add fluid to the cuff under pressure to maintain a desired inflation level. In an optional embodiment, a position sensing device (e.g., a solid-state gyroscope module) may be provided to detect orientation data of the cervical support device 1200 (e.g., the solid-state gyroscope module can detect the angle of the device relative to the gravity vector). Based on the position data, the device may be adapted to automatically adjust the angle of the device if the device deviates beyond a desired position (as set by a care provider).

[0058] It will be understood that the various different components and features of the cervical support device embodiments described herein and illustrated in Figures 1-57 may be adapted for use with any of the other embodiments disclosed herein.

[0059] Thus, the cervical support device of various exemplary embodiments detailed above provides a selectively adjustable device for supporting an insufficient cervix to promote gestational prolongation of preterm pregnancies. The cervical support device includes an upper or proximal cuff for supporting and / or clamping the patient's cervix to prevent the cervix from opening or further shortening. The proximal cuff can include multiple inflatable bladders that can be independently accessible (i.e., inflatable or deflated) to provide customizable support to the cervix based on the patient's specific needs. In preferred embodiments, the proximal cuff can provide lateral and downward forces (i.e., away from the uterus) on the cervix, thereby promoting retention of the cervix within the proximal cuff. A lower or distal cuff may be provided for seating or securing the main body of the device to the patient's vaginal wall. The distal cuff can also include multiple inflatable bladders that can be independently accessible to provide customizable support to the device. Preferably, the proximal cuff is shaped and dimensioned to allow blood flow from the upper cervix protruding through the proximal cuff to the lower cervix.

[0060] Examples of the present invention are as follows. [Example 1] a body defining an internal passageway for receiving the cervix, the body including upper and lower portions defining proximal and distal openings, respectively, to the internal passageway, and an outer surface for engaging the vaginal wall; a cuff coupled to the body at the proximal opening and configured to encircle at least a portion of the cervix, the cuff including an expandable portion adjacent a recess, the expandable portion selectively expandable further into the interior passage than the recess; 1. A cervical support and reinforcement device comprising: [Example 2] 2. The cervical support and reinforcement device of example 1, wherein the body comprises a hemispheroid shape and the proximal opening defines a smaller area than the distal opening. [Example 3] 2. The cervical support and reinforcement device of example 1, further comprising ridges disposed along an inner circumference of the cuff for gripping the outer surface of the cervix. [Example 4] 2. The cervical support and reinforcement device of example 1, wherein the cuff is configured to expand substantially radially inward toward an axial center of the proximal opening upon expansion. [Example 5] The cervical support and reinforcement device of Example 1, wherein the cuff is configured, upon expansion, to expand both radially inward and downward away from the cross-section of the proximal opening and away from the uterus as the cuff unfolds around the cervix. [Example 6] 6. The cervical support and reinforcement device of example 5, wherein the cuff comprises a non-uniform wall thickness. [Example 7] 6. The cervical support and reinforcement device of example 5, wherein the cuff comprises a plurality of inflatable bladders that are adjacent to and coaxial with one another. [Example 8] 2. The cervical support and reinforcement device of example 1, further comprising a rim disposed on the upper portion of the body and extending upwardly and away from the proximal opening, the rim configured to guide the cervix into the proximal opening when the cervical support and reinforcement device is positioned. [Example 9] The cervical support and reinforcement device of Example 1, further comprising an expandable second cuff disposed on one or both of the outer surface portion of the body and the lower portion of the body immediately proximate the distal opening, the second cuff expandable away from the axial center of the distal opening to expand toward the vaginal wall therein, the second cuff expandable from a neutral state to an expanded state in which the circumference of the second cuff is enlarged compared to its circumference when in the neutral state. [Example 10] 2. The cervical support and reinforcement device of example 1, further comprising a fluid conduit in fluid communication with the cuff and a valve in fluid communication with the fluid conduit on an opposite side of the cuff. [Example 11] The cervical support and reinforcement device of example 10, wherein the valve is operable to removably receive a portion of an inflation device operable to inflate the cuff without removing the cervical support and reinforcement device from the patient's vagina. [Example 12] The cervical support and reinforcement device of Example 10, further comprising an expandable second cuff disposed on one or both of the outer surface portion of the body and the lower portion of the body immediately proximate the distal opening, the second cuff being expandable away from the axial center of the distal opening so as to expand toward and into the vaginal wall, and the second cuff being in fluid communication with the fluid conduit. [Example 13] 2. The cervical support and reinforcement device of example 1, wherein the cuff comprises at least two of the recesses and at least two of the expandable portions spaced apart from the recesses. [Example 14] The cervical support and reinforcement device of Example 1, further comprising a pump and a fluid reservoir disposed within the body, the pump in fluid communication with the fluid reservoir, the fluid reservoir in fluid communication with the cuff, and the pump configured to move fluid between the fluid reservoir and the cuff for inflation and deflation of the cuff. [Example 15] 15. The cervical support and reinforcement device of example 14, further comprising a wireless control device for remotely controlling the pump. [Example 16] 1. A cervical support and reinforcement device for placement in the vagina, a body defining an internal passageway for receiving the cervix, the body including upper and lower portions defining proximal and distal openings, respectively, to the internal passageway, and an outer surface for engaging a vaginal wall to support the cervical support and reinforcement device immediately adjacent the cervix; a cuff coupled to the body at the proximal opening and configured to encircle at least a portion of the cervix, the cuff being expandable from a neutral state to an expanded state in which the cuff expands both radially inward and downward away from a cross-section of the proximal opening and away from the uterus; 1. A cervical support and reinforcement device comprising: [Example 17] The cervical support and reinforcement device of Example 16, wherein the cuff comprises one or more expandable portions adjacent to one or more recesses, the expandable portions being selectively expandable further into the internal passage than the recesses. [Example 18] 17. The cervical support and reinforcement device of Example 16, wherein the cuff comprises a non-uniform wall thickness. [Example 19] 17. The cervical support and reinforcement device of Example 16, wherein the cuff comprises a plurality of inflatable bladders that are adjacent to and coaxial with one another. [Example 20] The cervical support and reinforcement device of Example 16, further comprising a rim disposed on the upper portion of the body and extending upwardly and away from the proximal opening, the rim configured to guide the cervix into the proximal opening when the cervical support and reinforcement device is positioned. [Example 21] The cervical support and reinforcement device of Example 16, further comprising an expandable distal cuff disposed on the lower portion of the body immediately adjacent the distal opening, the distal cuff being expandable away from the axial center of the distal opening so as to expand toward and into the vaginal wall or fornix. [Example 22] 1. A cervical support device for placement within a vagina, comprising: a hemispheroid defining an internal passageway for receiving the cervix, the hemispheroid including upper and lower portions defining proximal and distal openings, respectively, and an outer surface for engaging a vaginal wall to support the cervical support device immediately adjacent the cervix; a cuff coupled to the hemispheroid at the proximal opening and configured to encircle at least a portion of the cervix; The cuff comprises: a first bladder coaxial with the proximal opening; and a second bladder coaxial with the first bladder and the proximal opening; Equipped with A cervical support device, wherein the first bladder and the second bladder are selectively inflatable and expandable into the internal passageway. [Example 23] The cervical support device of Example 22, wherein the cuff is expandable from a neutral state to an expanded state, and in the expanded state the cuff expands both radially inward toward the axial center of the proximal opening and downward away from the cross-section of the proximal opening and away from the uterus. Changes and modifications in the specifically described embodiments may be made without departing from the principles of the invention, which are intended to be limited only by the scope of the appended claims when interpreted in accordance with principles of patent law, including the doctrine of equivalents.

[0061] The following are excerpts from the accompanying drawings, which are shown in comparison with each other in the original application and the corresponding international application PCT / IB2022 / 056650 (whose international publication number is WO2023 / 026109). [Figure 3-4 shown in contrast] TIFF2025186477000002.tif241161 [Figures 5-6 shown in contrast] TIFF2025186477000003.tif241161 [Figures 7-8 shown in contrast] TIFF2025186477000004.tif241161 [Figures 12-13 shown in contrast] TIFF2025186477000005.tif241161 [Figure 14-15 shown in contrast] TIFF2025186477000006.tif241161 [Figures 16-18 shown in contrast] TIFF2025186477000007.tif241161 [Figures 19-20 shown in contrast] TIFF2025186477000008.tif241161 [Figures 21-22 shown in contrast] TIFF2025186477000009.tif241161 [Figures 29-31 shown in contrast] TIFF2025186477000010.tif241161

Claims

1. In cervical support and reinforcement devices, A cuff configured to encircle at least a portion of the cervix, a proximal opening, a distal opening, and an internal passageway between the proximal opening and the distal opening, the internal passageway configured to receive at least a portion of the cervix; and an outer surface for engaging a vaginal wall, A cervical support and reinforcement device, wherein the cuff is configured to expand from a neutral state to an expanded state, wherein the cuff is expanded both radially and downwardly into the internal passage, whereby when the cuff is in the expanded state, the cuff exerts a pulling force, pushing the cervix away from the uterus.

2. 10. The cervical support and reinforcement device of claim 1, further comprising a fluid conduit in fluid communication with the cuff, the fluid conduit configured to inflate the cuff by being in fluid communication with the cuff and to deflate the cuff by drawing fluid from the cuff.

3. 3. The cervical support and reinforcement device of claim 2, further comprising a valve in fluid communication with the fluid conduit.

4. 3. The cervical support and reinforcement device of claim 2, further comprising a valve in fluid communication with the fluid conduit, the valve operable to removably receive a portion of the inflation device operable to inflate the cuff without removing the inflation device from the patient's vagina.

5. 5. The cervical support and reinforcement device of claim 1, further comprising a distal cuff disposed on the outer surface and configured to extend into the vaginal wall.

6. 5. The cervical support and reinforcement device of claim 1, further comprising a plurality of cleats extending from an outer surface of the cuff.

7. 5. The cervical support and reinforcement device of claim 1, wherein the cuff further comprises at least two recesses and at least two expandable portions spaced apart from each other in alternating relation to the recesses.

8. In cervical support and reinforcement devices, A ring configured to encircle at least a portion of the cervix, a proximal opening, a distal opening, and an internal passageway between the proximal opening and the distal opening, the internal passageway configured to receive at least a portion of the cervix; an outer surface for engaging a vaginal wall; 1. A cervical support and reinforcement device comprising: a ring comprising: a plurality of cleats extending from the ring and configured to engage the cervix; A cervical support and reinforcement device, wherein the ring is configured to expand from a neutral state to an expanded state, wherein in the expanded state the ring is expanded both radially and downwardly into the interior passage, whereby the ring exerts a pulling force, pushing the cervix away from the uterus.

9. 10. The cervical support and reinforcement device of claim 8, further comprising a fluid conduit in fluid communication with the ring, the fluid conduit configured to fluidly communicate with the ring to inflate the ring and to withdraw fluid from the ring to deflate the ring.

10. 10. The cervical support and reinforcement device of claim 9, further comprising a valve in fluid communication with the fluid conduit.

11. 10. The cervical support and reinforcement device of claim 9, further comprising a valve in fluid communication with the fluid conduit, the valve operable to removably receive a portion of the inflation device operable to inflate the ring without removing the inflation device from the patient's vagina.

12. 12. The cervical support and reinforcement device of any one of claims 8-11, further comprising a distal cuff disposed on the outer surface and configured to extend into the vaginal wall.

13. 12. The cervical support and reinforcement device of claim 8, wherein the ring further comprises at least two recesses and at least two expandable portions spaced apart from each other in alternating relation to the recesses.

14. In cervical support and reinforcement devices, An expandable cuff configured to encircle at least a portion of the cervix, a proximal opening, a distal opening, and an internal passageway between the proximal opening and the distal opening, the internal passageway configured to receive at least a portion of the cervix; an outer surface for engaging a vaginal wall; and one or more expandable portions adjacent one or more recesses, A cervical support and reinforcement device, wherein the one or more expandable portions are configured to extend further into the internal passage than the one or more recesses, and the one or more recesses are positioned to receive a predetermined portion of the cervix, including the major cervical blood vessels, such that expansion of the cuff does not compress the major cervical blood vessels.

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