Menstrual plug

Abstract

A menstrual plug for insertion into a vagina comprises an outer chamber 02 with an opening 04 at its upper end, a drain opening 08 and a stopper 10. The stopper is attached to the outer chamber and is

Description

DESCRIPTION FIELD The present disclosure relates to a menstrual plug. More specifically, the present disclosure relates to a menstrual plug, which may comprise a menstrual cup, and which comprises a drain, a stopper, and an actuator, and a method of using the same. BACKGROUND AND INTRODUCTION Reusable containers for collecting menses (i.e., menstrual blood and related matter) are known and have been used at least since the 19th century. Such containers are commonly known as 'menstrual cups' and work by being inserted into the vagina to collect menses, whilst preventing escape of menses out of the vagina, and by being removed and emptied by the user at appropriate intervals. Collection of menses in a reusable container has a variety of advantages for both the user (e.g. comfort, financial cost) and the environment (e.g. reducing the impact of production and waste), compared to disposable sanitary towels and tampons. However, existing menstrual cups can be difficult to use. Some users find removing a menstrual cup to empty it, to be an invasive, messy, and unhygienic process, particularly where they are obliged to do so with a lack of privacy and / or without access to clean water. For example, it can be difficult when using toilets at places of work, in public places, or while travelling. It can also be problematic when users are in less developed regions or countries, where there may be limited sanitary facilities. Therefore, it has been identified that a traditional menstrual cup would be improved by the ability to empty it without entirely removing it. Any menstrual cup should still be removed, washed, and sanitised on a regular basis, but having an additional option for in situ emptying of a menstrual cup means that the user has control over when and where they remove it. Menstrual cups with drainage mechanisms for in situ emptying are known, and typically include one or more valves or caps, which can be manipulated or moved by the user, to enable fluid flow out of the cup. However, problems and disadvantages occur with such existing drainage mechanisms. For example, the user must insert their fingers into the vagina to open the valve or cap, which can be 29 07 24 almost as messy and invasive as removing a traditional menstrual cup to empty it. This also poses hygiene risks, particularly if access to hand washing facilities is difficult. Moreover, the valve openings tend to be very small, making them difficult for the user to manipulate, difficult to clean, and making it difficult and / or very slow for menses to flow out, especially when the blood is viscous. Additionally, the valves are located at the base of the menstrual cup, and some users have experienced leakage because the movement of their body accidentally opens the valve. In one existing cup, described in GB patent GB2425260, in the name of Kea-Flex Mouldings Limited, an outlet can be moved to outside the vagina, where the cap can be removed, but there are problems with this design. For example, the user must still insert their fingers into the vagina to grasp the outlet. Moreover, the menstrual cup is bulky and is likely to be uncomfortable against the cervix, removal of the cap is fiddly, and there is no mechanism by which the outlet can readily be returned to its collecting position. EP4042988 discloses a menstrual cup with a movable stopper actuated by a pull handle and CN109549771 discloses a menstrual cup with a drain valve that rotates between a first sealing position and a second open position, actuated by an electronic remote control. The present inventor has addressed the above-described issues. SUMMARY Aspects of the present disclosure are defined in the appended independent claims. There is disclosed herein a menstrual plug. The menstrual plug (which may also or instead be referred to as a 'menstrual cup') is arranged for insertion into the vagina, for controlling the flow of menses out of the vagina. The menstrual plug is formed from any suitable soft yet resilient material, to enable user comfort and to ensure a close fit between the outer walls of the menstrual plug and the walls of the vagina. This ensures that menses does not flow around an outer surface of the menstrual plug and leak out of the vagina, when the menstrual plug is properly inserted therein. Menses must flow instead through (at least part of) the menstrual plug, when it is properly inserted, in order to leave the vagina. The menstrual plug comprises a user-controllable stopper (or barrier, or bung) for sealing an opening (or drain) within the menstrual plug, thereby preventing flow of menses out of the vagina, except at times when the user chooses to move or otherwise reconfigure the stopper, and thus to allow such flow to occur. The menstrual plug does not need to be removed from 29 07 24 the vagina in order to allow such flow of menses. However, it can be removed from the vagina, whenever the user wishes to do so, and can be washed and re-used multiple times. The menstrual plug preferably comprises an outer container (or chamber, or receptacle), for collection of menses, when the menstrual plug is inserted in the vagina. However, alternative arrangements are also contemplated, wherein the plug has little or no capacity for collecting or holding menses, but wherein its predominant function is to act as a blockade and thereby to prevent flow of menses out of the vagina, except at user-selected times. The menstrual plug described herein comprises an actuator, which enables user-controlled movement or reconfiguration of the stopper. In embodiments, the actuator comprises a pull actuator, at least part of which is located below the stopper. For example, a distal part of the actuator may be located close to or below the vaginal opening, close to or below the labia majora, or external to the body, when the menstrual plug is suitably inserted. The actuator may, for example, comprise a cord or a string that can be pulled by the user, with or without a loop or other gripping means at the lower end, attached (either directly or indirectly) to the stopper. The actuator may be relatively long such that some length of it may extend out of the body, and it may hang freely or be placed in the user's underwear while the menstrual plug is in use, in the same manner as a tampon string. The actuator may be formed from a relatively thin length of any material, such as a hygienic, washable and reusable material. For example, it may be formed from the same hygienic materials as the rest of the menstrual plug, which could be (but is not limited to) silicone, natural rubber, or thermoplastic elastomers (TPE). The stopper comprised within the menstrual plug may comprise an inner container, which may allow fluid flow therethrough, at least at user-selected times. The inner container may thus be referred to as a 'conduit' and / or a 'vessel'. The inner container may comprise one or more apertures that can be moved, uncovered, reshaped, or otherwise reconfigured in relation to the outer container, in order to enable fluid flow from the outer container, out of the menstrual plug, and so out of the vagina. The actuator may be user-controlled, to move or configure said inner container to a fluid-flow position, and to return it to a collecting position. 29 07 24 When in a collecting position, the stopper (which may comprise an inner container, or conduit) forms a continuous surface with the outer container, thus together forming a sealed collector, which can collect menses when suitably positioned inside the body. When the stopper is in the collecting position, any aperture(s) within the stopper or outer chamber is / are closed and located wholly within the outer container, to prevent fluid flow out of the menstrual plug. When the stopper is moved or reconfigured to the fluid-flow position, one or more apertures therein may be moved externally to the outer container, thereby becoming unobstructed and allow the menses to flow out of the body. The stopper may be biased towards the collecting position. It may be biased towards, and / or returned to, its collecting position by virtue of one or more attachments of the stopper to the outer container. Such attachment(s) may be physically direct or indirect. Elasticity in one or more of: the attachment(s), the stopper, and / or the inner container (if present) may create flexibility of movement such that the stopper / inner container is moveable or deformable when the user pulls on the actuator, to activate fluid flow out of the menstrual plug, while also maintaining some tension so that the stopper / inner container returns to its collecting position after release of the actuator. Alternatively, a combination of flexibility and tension may be created by the distortion of at least part of the outer container, which may be made from a semi-resilient material that can be distorted under force, when the user actuates the actuator, but which returns to its original shape when pressure is released. This can be done without moving or dislodging the entire menstrual plug, within (or from) the vagina. The menstrual plug described herein has many advantages as compared to existing drainage mechanisms for known menstrual cups. For example, because the user can pull on an actuator or string to drain the menses, without removing the menstrual plug from the vagina and without directly contacting the main body of the menstrual plug, the process is much easier, more hygienic, less messy, and less invasive than conventional approaches. Because the stopper and / or an aperture provided in the stopper (or inner container) can be relatively large, the surface area through which menstrual blood is free to flow can be large, enabling relatively easy and quick flow, even of viscous menstrual blood. Because the stopper can be relatively large and robust, and can be resiliently biased towards a closed position, the opening(s) in the menstrual plug is / are unlikely to be accidentally opened by body movement. A further advantage could be, for example, that because the user can pull on the actuator to drain the menses and then continue to pull on the actuator to 29 07 24 remove the menstrual plug, removal of the menstrual plug is very convenient. Removal by this method is safe because pulling on the actuator opens the drain and breaks the suction seal with the walls of the vagina, and it is less messy because the menstrual plug will usually already be empty when it is removed. According to an aspect, a menstrual plug is provided, for insertion into a vagina, the menstrual plug comprising an outer chamber, comprising a fluid receiver and a drain. The menstrual plug further comprises a stopper that is attached to the outer chamber and is moveable between first and second (respectively different) positions. In the first position, the stopper forms a seal to prevent fluid flow out of the drain. In the second position, the stopper permits fluid flow out of the drain. The menstrual plug further comprises an actuator for moving the stopper between the first and second positions. The menstrual plug may comprise a menstrual cup. The outer chamber may be substantially cup-shaped, or substantially U-shaped, or substantially V-shaped, or substantially frustoconical shaped, in vertical cross-section. Alternatively, the outer chamber may be substantially flat, only slightly curved, or include an inverted U-shape, V-shape, or cup-shape in vertical cross-section. The fluid receiver may comprise an inner surface of the outer chamber, such as a base surface. The fluid receiver may comprise at least one opening, for example an opening located substantially at an upper end of the outer chamber, when the menstrual plug is suitably inserted in the vagina. The opening(s) of the fluid receiver may occupy substantially all the horizontal cross-sectional area of the menstrual plug, at the upper end of the outer chamber. The outer chamber may comprise a wall or walls that define(s) the opening(s) of the fluid receiver. The drain may comprise at least one opening, formed at a lower end of the outer chamber, when the menstrual plug is suitably inserted in the vagina. The drain may be provided substantially distal to the fluid receiver. The surface area of the opening(s) at the drain may be relatively smaller than the (combined) surface area of the opening(s) of the fluid receiver. The stopper may be solid or may be at least partially hollow. At least part of the stopper may be sized and shaped to correspond with an opening (or openings) in the drain so that, when it is in the first 29 07 24 position, a seal is formed that prevents escape of menses from the plug. The stopper may include a rim or other protrusion, that may be located below the drain, to help seal the opening(s) in the drain. 'Movement' of the stopper to the second position, may comprise movement of part or all of the stopper. For example, the stopper may be formed of elastically resiliently material. For example, moving the stopper from the first position to the second position may comprise actuating the actuator to stretch at least part of the stopper, away from forming a seal with the drain of the outer chamber, and thus enabling fluid flow out of the drain, either around and / or through the stretched stopper. The stopper may thus be configured so that at least one of its size and / or its shape is different in the second position, as compared to the first position. Thus, 'movement' of the stopper may instead be referred to as being 'actuation' or '(re)configuration' of the stopper. The first and second positions may be referred to as, respectively, first and second positions or configurations of the stopper. The stopper may be attached indirectly or directly, permanently or temporarily, to the outer chamber. There may be one or more attachments between the stopper and the outer chamber. The attachment(s) may ensure that the stopper is not entirely removed from the menstrual cup, when it is moved to the second position. For example, the attachments may comprise one or more relatively thin bands of material, extending from the stopper, such as an upper part of the stopper, to a surface of the outer chamber. The actuator may be arranged for moving the stopper between the first and second positions whilst the menstrual plug remains inserted in the vagina. Thus, the user does not have to remove the menstrual plug from their body each time they need to empty the contents of the menstrual plug or need to check whether it is empty. This gives the user greater ownership and flexibility in relation to the use of their menstrual plug, and reduces potential infection risks that inappropriate, non-ideal and / or non-sanitary conditions may otherwise present. It is especially advantageous for users who frequently need to check that their menses flow has not exceeded the capacity of the menstrual plug, such as those with a heavy menstrual flow, those new to using menstrual cups, those with anxiety about the use of menstrual cups, or those with an irregular / unpredictable flow (including but not limited to users who have recently started their periods, are perimenopausal, or have menstrual disorders). Thus, the menstrual plug is a safer and more suitable choice of sanitary product than conventional menstrual cups for a wide range of users, including those whose access to convenient facilities may be limited by personal or regional poverty, working conditions, lifestyle, displacement, war, or other types of violence. 29 07 24 The actuator may be configured to move the stopper out of its first position, in which it seals the drain, and into the second, fluid-flow position, without removing the stopper entirely from the vagina and without detaching the stopper from the rest of the menstrual cup. This enables fluid to flow out of the menstrual plug, and so out of the body, under the user's control, without risk of the stopper becoming dirty, or being lost, during its movement / reconfiguration. In other words, actuation of the actuator can be used to empty the menstrual plug. There is no need to remove or detach any part of the menstrual plug, for it to be emptied (i.e., for it to enable fluid flow therethrough, and out of the vagina, under the user's control). In other words, simply actuating the actuator, to move or reconfigure the stopper from its first position to its second position, is sufficient to empty the fluid from the menstrual plug. No additional user steps are needed, when the stopper is in the second position. Moreover, it will be appreciated that the fluid may begin draining when the stopper is in between the first and second positions (i.e., during the actuation of the actuator, to move / reconfigure the stopper.) At least part of the actuator may be located distal to the stopper, when the menstrual plug is suitably inserted in the vagina. For example, the actuator may be a pull-type (or pull-activated) actuator. For example, it may comprise a string or cord that extends downwardly from the menstrual plug, when it is suitably inserted in the vagina. The actuator may have a loop or other gripping means at its distal end. The distal end of the actuator may be located close to, or downstream of, the vaginal opening, when the menstrual plug is suitably inserted in the vagina. This enables easy user access, for moving the stopper. It may also enable the user to move the actuator at least partially to one side, away from the flow of menses out of the vagina, whilst the menstrual plug is being emptied. Thus, the emptying process may be cleaner and more hygienic for the user. The actuator may therefore ensure that the stopper does not have to be touched directly by the user and the stopper does not have to encounter a non-sterile environment, outside the body. Moreover, the user may access the actuator relatively easily, to move the stopper. Therefore, use of the menstrual plug, and in particular the action of using the actuator to empty or at least partially empty 29 07 24 the contents of the menstrual plug, without removing it in its entirety from the vagina, is easier, less messy and more hygienic than is possible with previously-known menstrual cups. The stopper may comprise a conduit. The conduit may comprise a first, open end, for receiving fluid flow from the outer chamber, at least when the stopper / conduit is in the second position. The conduit may further comprise a second, closed end, with a wall defined between the first and second ends and at least one aperture provided in said wall. Alternatively, the conduit may comprise first and second open ends, wherein fluid flow between the first and second open ends is permitted when the stopper / conduit is in the second position, but not when it is in the first position. For example, the menstrual plug may provide a ceiling or other barrier, within the outer chamber, that prevents fluid access to one or both of the open ends of the stopper / conduit, when it is in the first position. The conduit may comprise an aperture that is arranged to be in fluid communication with an environment that is external to the menstrual plug, when the conduit is in the second position. That aperture may comprise an opening in an end of the conduit and / or may comprise an opening in a wall of the conduit. By virtue of the aperture, fluid received by the conduit may flow through and out of the conduit, when the stopper / conduit is in the second position. When the conduit is in the first position, the aperture may be wholly located within the outer chamber. Therefore, in such embodiments, fluid flow out of the outer chamber, via the aperture, is not permitted when the stopper / conduit is in the first position. Fluid flow into and / or out of the aperture may be prevented, when the stopper / conduit is in the first position. When in the second position, the stopper / conduit may permit fluid to flow either directly or indirectly out of the drain. For example, it may flow at least partially indirectly, via one or more apertures provided in the stopper. In such embodiments, the aperture(s) may be wholly housed within the upper chamber, when the stopper is in the first position. In such embodiments, fluid flow to and / or out of the aperture(s) may be prevented, when the stopper is in the first position. When the stopper is in the second position, at least some / part of its aperture(s) may be located downstream of at least part of the drain, to enable fluid to flow out of the drain, via the aperture(s). 29 07 24 The aperture(s) may be provided in a wall of the stopper / conduit. The size of the drain and / or the aperture(s) may be relatively large, for example they may be larger than the average size of clots that occur frequently in menses. This has the advantage of enabling quick and easy flow of menses for all users, including those who experience heavy flow and / or clots in their menstrual blood. There may be an elastic attachment, which may be direct or indirect, between the stopper and the outer chamber. This may enable the stopper to move relative to at least part of the upper chamber, under control of the actuator, to / towards the second position. It may also / instead enable the stopper to return to the first position in the absence of an actuation of the actuator, or in response to actuation of the actuator in a substantially opposite direction. At least part of the outer chamber and / or at least part of the stopper may be formed from an elastic material. Therefore, in response to an actuating force (such as a pull action) on the actuator, either at least part of the stopper may stretch elastically, and / or at least part of the upper chamber may stretch or fold elastically, to enable the stopper to move or reconfigure from the first position to the second position. If at least part of the stopper is formed from an elastic material, movement of the stopper from the first position to the second position may comprise stretching at least part of the stopper, so that it no longer forms a fluid-tight seal with the drain of the outer chamber of the menstrual plug. The stopper may be biased towards being in the first position, in the absence of an actuating force on the actuator. It may be possible for the user to actuate the actuator, to return the stopper to the first position from the second position. According to an aspect, a menstrual plug is provided, for insertion into a vagina, the menstrual plug comprising an outer chamber comprising a fluid receiver and a drain. The menstrual plug further comprises a stopper that is attached to the outer chamber and is configurable between first and second (respectively different) configurations. In the first configuration, the stopper forms a seal to prevent fluid flow out of the drain. In the second configuration, the stopper permits fluid flow out of the drain. The menstrual plug further comprises an actuator for (re)configuring the stopper between the first and second configurations. 29 07 24 The menstrual plug may comprise a menstrual cup. The shape, size, position and / or form of the stopper in the first configuration may be different to the respective shape, size, position and / or form of the stopper in the second configuration. For example, at least part of the stopper may be stretched or distorted when it is in the second configuration, as compared to its shape / size / position / form when it is in the first configuration. The location of at least part of the stopper, relative to at least part of the outer chamber, may be different in the first configuration as compared to the second configuration, and vice versa. Changing / reconfiguring the stopper from the first configuration to the second configuration may comprise moving the stopper, including but not limited to shifting, bending, folding, compressing, stretching and / or rotating the stopper, with or without substantially changing its shape, size, position or form. The menstrual plug may be formed using any suitable manufacturing method. For example, the menstrual plug may be formed as a single entity, with the outer chamber, stopper and actuator being integral thereto. The method may comprise forming the menstrual plug from two or more component parts. The component parts may be attached directly or indirectly to one another in a permanent manner, or may be attached to one another with a temporary fixing which enables the user to detach the components (thereby facilitating cleaning of the menstrual plug). The method may comprise forming some or all of the menstrual plug from a washable, re-usable, non-absorbent material. The method may comprise forming some or all of the menstrual plug from a BPA-free, latex-free, hypogenic, flexible material, to aid user comfort. The method may comprise forming some or all of the menstrual plug from an elastic material. The material may comprise one or more of: silicone, natural rubber, or thermoplastic elastomers (TPE). The design and manufacture process may comprise the selection of which component parts are deformable and to what extent, in order to achieve the desired movement of the stopper while retaining sufficient rigidity to stay in place in the vagina. The manufacture process may treat different components of the menstrual plug differently, depending on factors including, but not limited to, the required elasticity of each component. For example, some components may be heated at different temperatures or for different amounts of time, formed from different thicknesses of material, or from materials with different compositions. 29 07 24 According to an aspect, a method is provided of intra-vaginal use of a menstrual plug according to (or manufactured according to) the above aspects. BRIEF DESCRIPTION OF THE DRAWINGS Specific embodiments are described by way of example only. The included figures are as follows: Figure 1 shows a cross-section of a menstrual plug that does not have moveable apertures, with its stopper in a first, collecting position. This figure does not illustrate an embodiment of the current invention; Figure 2 shows a cross-section of the menstrual plug of Figure 1, with its stopper in a second, fluidflow position (also not an embodiment of the current invention); Figure 3a shows a cross section of a menstrual plug according to an embodiment, with its stopper in a first, collecting position; Figure 3b shows a perspective view of the menstrual plug of Figure 3a; Figure 4a shows a cross-sectional view of the menstrual plug of Figures 3a and 3b with its stopper in a second, fluid-flow position; Figure 4b shows a perspective view of the menstrual plug of Figure 4a; Figure 5a shows a cross-sectional view of an alternative option for the menstrual plug of Figures 3a and 3b with its stopper being stretchable, and in a second, fluid-flow position; Figure 5b shows a perspective view of the menstrual plug of 5a; Figure 6a shows a cross-sectional view of another alternative option for a menstrual plug of Figures 3a and 3b with part of the outer chamber being foldable, and the stopper being in a second, fluidflow position; Figure 6b shows a perspective view of the menstrual plug of Figure 6a; Figure 7a shows another embodiment of a menstrual plug with its stopper in a first, collecting position; Figure 7b shows a perspective view of the menstrual plug of Figure 7a; 29 07 24 Figure 8a shows a cross-sectional view of the menstrual plug of Figures 7a and 7b with its stopper in a second, fluid-flow position; Figure 8b shows a perspective view of the menstrual plug of Figure 8a; Figure 9a shows a cross-sectional view of a further embodiment of the menstrual plug with its stopper in the first, collecting position; Figure 9b shows a perspective view of the menstrual plug of 9a; Figure 10a shows a cross-sectional view of the menstrual plug of Figures 9a and 9b, with its stopper in a second, fluid-flow position; Figure 10b shows a perspective view of the menstrual plug of Figure 10a; Figure 11 shows a cross-sectional view of an embodiment similar to the menstrual plug of Figures 9a and 9b, but in which the stopper is more fully encased in the housing of the outer chamber. Shown in a first, collecting position. Figure 12 shows a perspective view of another embodiment of the menstrual plug, with its stopper in a first, collecting, position. The outer chamber is shown with dotted lines as if it were transparent. DETAILED DESCRIPTION An invention is set out in the claims. Embodiments are described below in relation to the figures, for the purpose of illustration. Terms of a singular form may include plural forms unless specified otherwise. Any positional terms such as 'upper', 'lower', 'vertical, 'horizontal', 'inner', 'outer', and so on are used illustratively, to aid reader understanding of the described aspects and embodiments, and should not be construed as limiting. 29 07 24 Although the terms "first" "second" etc. may be used herein to describe various elements, these elements are not to be limited by these terms. These terms are only used to distinguish one element from another. In general terms, a menstrual plug is disclosed herein, which may instead / also be referred to as a menstrual cup. The menstrual plug is for intra-vaginal use. In other words, it is for insertion into the vagina, for user-selected prevention of the escape of menses from the vagina, except at times when the user chooses to control the menstrual plug to allow escape of the menses (for example, when emptying it into a lavatory or other suitable receptacle). The menstrual plug has a mechanism for drainage without removal from the user's body. An inner vessel or stopper is attached to an outer container, and the menstrual plug comprises one or more apertures that are moveable in size, shape, or location between first and second positions. In the first position, the inner vessel and the outer container together form a continuous surface, so that the container can collect menses when in use. In this position, the moveable aperture(s) are located within the outer chamber forming a seal to prevent fluid flow out of the drain. To drain the menstrual plug, the user pulls on an actuator, such as a string, and moves the inner vessel into a position in which the menstrual blood can flow out of the body. In this second position, the moveable aperture(s) are arranged to be in fluid communication with an environment that is external to the menstrual plug. When the user releases the string, the attachment between the inner vessel and the outer container returns the inner vessel to the collecting position. Thus, the drainage mechanism enables reliable, hygienic, and efficient user control of the emptying of menses from their menstrual plug. Figures 3a, 3b, 4a and 4b show an embodiment of a menstrual plug, as disclosed herein. Figure 3a shows a cross section of a menstrual plug according to an embodiment in a first, collecting position, and Figure 3b shows a perspective view of the menstrual plug of Figure 3a. The menstrual plug is shown in the orientation in which it would be situated when suitably inserted into the vagina, if the upper part of each drawing is taken to represent the upper end of the vaginal canal (closer to the cervix), and the lower part of each drawing is taken to represent the lower end of the vaginal canal (closer to the labia). The menstrual plug of Figures 3a&b and 4a&b is shown as being substantially cup-shaped, and as such is substantially U-shaped in vertical cross-section (i.e., in the xy plane, as depicted in Figures 3 29 07 24 and 4). However, it may be formed in different cross-sectional shapes, such as substantially conical, and V-shaped in cross-section, or substantially frustoconical, and will still function and perform as described herein. The menstrual plug comprises an outer container, or outer chamber, 02, with a first opening 04 defined at a first, upper end (when oriented as illustrated in Figures 3 and 4), wherein said opening is substantially circular in cross-section and is defined by an upper rim 06 of the outer container 02. At its distal end (which is a lower end, in the orientation of Figures 3 and 4), there is a second, lower opening 08, which can function as a drain, for releasing menses from the menstrual plug at user-selected times. Other cross-sectional shapes of the opening 04 are possible - such as, but not limited to, oval, elliptical and irregular shapes. However, the menstrual plug should be sized and shaped to fit comfortably and snugly into the vagina, being held in place substantially by virtue of its shape and size, and by the musculature of the vaginal walls. An inner container, conduit or vessel 10 is also comprised within the menstrual plug. In Figures 3a and 3b, this vessel is located such that its lower end is within the second opening 08 and surrounded by the rim 12 of the outer container 02. In this position, the apertures of the inner vessel 20 are located entirely within the outer container 02, meaning that the base of the inner vessel forms a continuous surface with the outer container, such that a fluid-tight seal, or closure, is formed and menses is collected. The inner vessel may include a protrusion or rim 22 that is wider than the second opening 08 of the outer container, to enhance the seal formed therebetween. Other shapes of the inner conduit 10 are possible - such as, but not limited to, cylindrical, spherical, frustoconical, and it may be, for example, substantially funnel-shaped, cup-shaped, U-shaped, or V-shaped in vertical cross-section. Other aspects of the inner conduit may also vary, such as the relative size compared to the outer chamber, the thickness, and the proportions of the conduit, as well as the number, location, shape and size of the openings. There is a plurality of attachments 14 that extend from the inner vessel 10, towards the upper rim 06 of the outer container 02, in order to securely attach the vessel 10 to the outer container 02. These attachments are similar to those described above in relation to the embodiment depicted in Figures 1 and 2: there are three such attachments shown in this example, but a different number, location, and nature of the attachments may be provided. There is an actuator 16, or pull-cord (or string), extending substantially downwardly from the inner vessel 10. As described above with reference to the embodiment depicted in Figures 1 and 2, the 29 07 24 actuator may be formed integrally with the vessel or attached to it in any suitably reliable manner, and the distal end of the actuator 16 may have a loop or other gripping means. In one example, the embodiment depicted in a first, collection position in Figures 3a and 3b, may have attachments 14 that are stretchable. Figures 4a and 4b show this example in a second position / configuration, under force exerted by the user, which allows fluid-flow out of the menstrual plug. In this example, the attachments 14 have stretched under the pulling force exerted by the user on the actuator 16, and so on the inner vessel / conduit. The rim 12 at drain in the outer container may be narrower than the upper opening of the conduit, and thus preventing the conduit from exiting the outer container when force is exerted by the user. In this position, menses previously collected in the outer container, can flow into the upper opening 18 of the conduit, and out of the opening 20 in the side wall of the conduit, out of the user's body. The inner surface of the base 24 of the vessel 10 may be slanted towards the hole 20, to enhance blood flow and enable complete drainage. The attachments 14 in this example are biased so that when the user stops pulling on the actuator, the conduit will return to its first, fluid-collection position, in sealing engagement with the drain. In another example, the embodiment depicted in Figures 3a and 3b may have an inner vessel / conduit which is in whole or part stretchable. Figures 5a and 5b show this example of the menstrual plug in a second position / configuration, allowing fluid flow out of the menstrual plug. A portion of the inner vessel or the whole inner vessel 10 may be made from elastic materials, in combination with the attachments 14 being made either of elastic or non-elastic materials. In Figures 5a and 5b, the inner vessel has been stretched under the pulling force exerted by the user on the actuator 16. Thus, a portion of the vessel 10 extends below the base of the outer container and the menses can flows out. The force of the actuator may additionally enlarge the hole or holes 20 in the inner vessel, to enable maximum flow. The arrangement of the inner vessel 10 in this example is biased so that when the user stops pulling on the actuator, the conduit 10 will return to its first, fluidcollection position, in which the opening of the inner vessel is within the outer container 02 and does not allow fluid-flow through the drain. In another example, the embodiment depicted in a first, collection position in Figures 3a and 3b, may vary such that neither the attachments nor the conduit are stretchable. Figures 6a and 6b show this 29 07 24 example in a second position / configuration, under force exerted by the user, which allows fluid-flow out of the menstrual plug. In this example, there may be one attachment 14 between the conduit 10 and the rim 06 of the outer container 02. Under force on the actuator, the rim 06 of the outer container folds or bends inwards so that the inner conduit 10 can move to a position below the base 12 of the outer container 02. In this position, similar to the descriptions of Figures 4 and 5 above, menses can flow into the upper opening 18 of the conduit, and then flow out of the opening 20 in the side wall of the conduit, to exit the user's body. In this example, the semi-resilient upper rim 06 may be biased to the first position, so that when the user releases the actuator the rim returns to its original shape, thus pulling on the attachment 14 and the conduit 10, such that the whole menstrual plug returns to the first, collecting position / configuration. Figures 7a and 7b show a further embodiment of the menstrual plug. In this embodiment the menstrual plug comprises an outer container, or outer chamber, 02, similar to that described above in relation to the embodiment shown in Figures 1 and 2, but whose second, lower, or distal opening differs in nature as shall now be described. In this example, the rim 12 which surrounds the drain 08 of the outer container 02 is raised to form a housing 26 for the conduit 10 which is situated within the body of the outer container. This extended rim, or housing, in this example is cylindrical and houses a cylindrical inner vessel, but it will be appreciated that this is just one possible shape. In this example, the housing 26 comprises a solid ceiling close to the opening 18 of the inner vessel 10, and walls between the ceiling and lower rim 12, which have one or more apertures 28. In the first, collecting, position, shown in Figures 7a and 7b, the inner vessel and the outer container form a continuous surface and menses are collected because all the openings are obstructed: the side walls of the conduit obstruct the openings 28 in the housing 26, and the housing 26 may provide a ceiling that prevents fluid access to the open ends 18,20 of the conduit. There is a plurality of attachments 14 that extend from the conduit 10, towards the ceiling of the housing 26, in order to securely attach the conduit / stopper 10 to the outer container 02. These attachments are similar to those described above in relation to the embodiment depicted in Figures 1 and 2: there are three such attachments shown in this example, but a different number, location, and nature of the attachments may be provided. There is an actuator 16, or pull-cord (or string), extending substantially downwardly from the inner vessel 10. As described with reference to the depicted in Figures 1 and 2, the actuator may be formed integrally with the vessel or attached to it in any suitably reliable manner, and the distal end of the actuator 16 may have a loop or other gripping means. 29 07 24 Figures 8a and 8b show the menstrual plug from Figures 7a and 7b in a second, fluid-flow, position. In this position, the inner vessel / conduit 10 is displaced such that it no longer obstructs the opening(s) 28, meaning that menses can exit the outer chamber through these openings. The vessel 10 comprises two open ends 18,20. In the second, fluid-flow position, menses can flow into one open end 18 and exit the menstrual plug via the other one 20, and from there exit the user's body. The arrangement of the inner vessel 10 in this example is biased so that when the user stops pulling on the actuator, the conduit 10 will return to its first, fluid-collection position, in which the inner vessel obstructs the opening(s) 28 and does not allow fluid-flow. In yet further embodiments (not depicted) the outer chamber 02 and raised housing 26 could be as shown and described in Figures 7a and 7b, but instead (or as well as) the attachment 14 being stretchable, the vessel or a portion of the vessel could be stretchable, and the arrangement of the openings could be varied, so that the inner vessel function similarly to that depicted in 5a and b. Figures 9a and b, and Figure 10, show a cross section of a menstrual plug according to a further embodiment. Figures 9a and b show the menstrual plug in a first, collecting position. The outer container 02 of the menstrual cup is shown as being substantially disk-shaped, with a slightly raised outer rim 06. Somewhat similar to the embodiment depicted in Figures 8a and b, the rim around the drain is also raised, such that it forms a housing 26 for the stopper / vessel. This housing may be substantially the shape of a semi-sphere as shown, or could be shaped differently. A stopper, or bung 10, is also comprised within the menstrual plug, and may be approximately the size and shape of a tampon. This has the advantage that the overall shape and method of inserting the menstrual plug may feel more familiar to users who are already familiar with tampons. The stopper of this embodiment may be substantially solid (i.e., without openings), but could be entirely or partially hollow. The stopper, which may be longer than the outer chamber is wide, maintains the orientation of the menstrual plug in relation to the vaginal canal, and in addition may be weighted such that it is heavier at the lower end, to further help the menstrual plug to remain in the correct orientation. The stopper may be attached directly to the housing 14, as shown, or may be attached indirectly. In the collecting position, the upper part of the stopper 10 is located within the housing, such that it obstructs the openings 28. In this position the outer container and the stopper form a continuous surface such that menses are prevented from exiting the vaginal canal by the menstrual plug, and are prevented from passing around the sides of the menstrual plug by the suction formed between the rim of the outer container and the walls of the vaginal canal. There is an actuator 16, or pull-cord (or string) extending substantially downwardly from the stopper 10. As with the other embodiments already described, the actuator may be formed integrally with 29 07 24 the stopper or attached to it in any suitably reliable manner, and may include a loop or other gripping means at the distal end. When the menstrual plug is suitably inserted in the vagina, the user can pull on the actuator 16, which in this embodiment moves the stopper and the housing 26 downward in relation to the rest of the outer container 02. As the housing becomes inverted compared to its first position, the stopper is no longer located within the housing, and moves away from the walls of the housing 26, causing the openings 28 to become unobstructed. In this position, menses can flow out of the drain 08, through the openings 28, and around the sides of the stopper 10 to exit the user's body. In this example the housing 26 is biased so that when the user stops pulling on the actuator, the housing and the stopper will return to the first, fluid-collection position, in sealing engagement with the drain. In Figures 9 and 10 this embodiment is shown with the largest part of the stopper 10 located below the outer chamber 02 in the first, collecting position. It will be appreciated that the proportions could be varied such that a larger part of the stopper would be located above the outer chamber 02, within the housing 26, in the collecting position. For example, half or even all of the stopper could be situated within the housing in the collecting position, as illustrated in Figure 11. This example has the additional advantage that after the user releases the actuator and the stopper returns to the collecting position, any menses that have stuck to the side of the stopper are returned to a position above the outer chamber and will not flow out of the body. Users may also find it even easier to insert. Tension on the actuator may cause the stopper to move in relation to the outer chamber to which it is attached 14, due to elasticity or flexibility in one or more of the following: part or all of the housing 26 of the outer chamber 02 (in a similar manner to the menstrual plug shown in Figures 10a and 10b); the attachments 14; or part or all of the stopper / conduit 10. The decision as to what proportion of the stopper would sit within the housing versus below the outer chamber would depend on many factors, including but not limited to the elasticity of the outer chamber material, with a likely goal being that the appropriate tension on the actuator would invert the housing, but that the menstrual plug would also remain biased to the collecting position and return to that position once the user releases tension on the actuator. The overall shape of the stopper and housing may be substantially cylindrical as shown, but may also take a variety of other shapes including but not limited to conical, frustoconical, funnel shaped or cup-shaped, or could take an inverted U-shape or V-shape in vertical cross-section. One possible advantage of sloping walls (for example, if the stopper and housing were conical, with the narrowest point at the ceiling of the housing, not shown) could be that the menstrual plug would begin to empty as soon as force was applied to the actuator. 29 07 24 Lastly, Figure 12 shows an embodiment of the menstrual plug similar to that described in relation to Figures 7 and 8 above, but having a cross-sectional shape similar to the menstrual plug depicted in Figure 11. As per the example depicted in Figures 7 and 8, the conduit 10 is cylindrical in shape with an opening at each end 18,20. The raised housing 26 of the outer chamber 02 comprises a solid ceiling close to the opening 18 of the inner vessel 10, and walls between the ceiling and the drain in the outer container 02, which have one or more apertures 28. In the collecting position, the conduit and the outer container form a continuous surface and menses are collected because all the openings are obstructed. In the fluid-flow position, tension on the actuator 16 displaces the conduit to a lower position in relation to the outer chamber, meaning the conduit no longer obstructs the opening(s) 28 and menses can pass through. The menses enters the conduit 10 through one open end 18 and from there exits the menstrual plug via the other end 20 of the conduit. Tension on the actuator may cause the conduit to move in relation to the outer chamber to which it is attached 14, due to elasticity or flexibility in one or more of the following: the attachments 14; part or all of the conduit 10; or part or all of the housing 26 of the outer chamber 02 (thereby enabling it to stretch, invert, fold, bend or otherwise distort). As with the other embodiments, the menstrual plug can be biased such that when the user releases the tension on the actuator, the menstrual plug returns to its first, collecting position. Hence, a useful, reliable menstrual product is provided, which enables the user not only to manage the flow of blood during menstruation, but to have greater freedom, flexibility and control compared to existing menstrual products. The product has advantages for many potential users, but may be especially advantageous for those with a heavy menstrual flow, those new to using menstrual cups, those with anxiety about the use of menstrual cups, and those with an irregular / unpredictable flow, as well as those whose access to hygienic facilities may be limited by personal or regional poverty, working conditions, lifestyle, displacement, war, or other types of violence. It will be apparent to those skilled in the art that various modifications and variations can be made without departing from the scope of the appended claims. The present disclosure covers all modifications and variations within the scope of the appended claims and their equivalents.

Claims

29 07 241. A menstrual plug, for insertion into a vagina, comprising:an outer chamber comprising a fluid receiver and a drain; anda stopper;the stopper being attached to the outer chamber, wherein at least part of the stopper is moveable between first and second positions;wherein, in the first position, the stopper forms a seal to prevent fluid flow out of the drain; andwherein, in the second position, the stopper permits fluid flow out of the drain; andone or more apertures that are moveable in size, shape, or location between first and second positions;wherein, in the first position, the aperture is located within the outer chamber forming a seal to prevent fluid flow out of the drain; and wherein, in the second position, the aperture(s) is arranged to be in fluid communication with an environment that is external to the menstrual plug;the menstrual plug further comprising an actuator for moving at least part of the stopper between the first and second positions.

2. The menstrual plug of claim 1 wherein the actuator is arranged for moving at least part of the stopper between the first and second positions whilst the menstrual plug remains inserted in the vagina.

3. The menstrual plug of claim 1 or claim 2 wherein at least part of the actuator is located distal to the stopper, when the menstrual plug is inserted in the vagina.

4. The menstrual plug of any preceding claim wherein the stopper comprises the moveable aperture, thus acting as a conduit.

5. The menstrual plug of claim 4 wherein the conduit comprises first and second open ends and wherein the outer chamber comprises a barrier for preventing fluid access to at least one of said first and second open ends of the conduit, when it is in the first position.29 07 246. The menstrual plug of any of claims 4 and 5 wherein the conduit stopper comprises a first open end and a second closed end, with a wall defined between said first, open end and said second, closed end, wherein the moveable aperture is formed in said wall.

7. The menstrual plug of any preceding claim wherein the actuator comprises a pull-type actuator.

8. The menstrual plug of any preceding claim further comprising an elastic attachment between the stopper and the outer chamber.

9. The menstrual plug of any preceding claim wherein at least part of the outer chamber and / or at least part of the stopper is formed from an elastic material.

10. The menstrual plug of any preceding claim wherein the stopper is biased towards being in the first position, in the absence of an actuating force on the actuator.

11. The menstrual plug of any preceding claim wherein the stopper is configured so that at least one of its size and / or its shape is different in the second position, as compared to the first position.

12. The menstrual plug of any preceding claim wherein the outer chamber is configured so that at least one of its size and / or shape is different in the second position, as compared to the first position.

13. The menstrual plug of any preceding claim wherein the outer chamber is substantially disc shaped.

14. The menstrual plug of any preceding claim wherein part or all of the stopper is housed, in the first position, within a portion of the outer chamber.

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