EP3200734A1

EP3200734A1 - Hygiene device

Info

Publication number: EP3200734A1
Application number: EP15784477.0A
Authority: EP
Inventors: Liita lyaloo NAUKUSHU
Original assignee: Kalitasha Ltd
Current assignee: Kalitasha Ltd
Priority date: 2014-10-02
Filing date: 2015-10-02
Publication date: 2017-08-09
Also published as: WO2016051385A1; GB201417457D0

Abstract

A reusable hygiene device configured to collect or store biological fluid, the device comprising a reservoir for receiving biological fluid; and members which, in use, engage a user's upper thigh to hold the device in place.

Description

Hygiene device

Field of the disclosure

The present disclosure provides a reusable feminine hygiene device for collecting/absorbing biological fluid eliminating the risk of leakage of said biological fluid, while maintaining the comfort of the user.

Background

Tampons and sanitary napkins are the most widely used products for managing the menstrual cycle. In developed countries most of these products are disposable and, while they are a convenient solution, they are expensive and their handling has a great environmental impact. It is calculated that each female uses on average 17,000 sanitary napkins and/or tampons during her fertile years to manage the menstruation. Disposable menstruation management products are generally manufactured from bleached pulp and plastic and they often contain non-biodegradable materials such as adhesives and plastic packaging. Both the packaging and the menstruation management products end up in landfill.

Low-income women in developing countries cannot afford to buy these disposable products or have restricted access to them. Many women in this socioeconomic situation resort to ineffective and often unhygienic methods to manage their menses, such as old rags, bark and even newspapers. This can lead to urinary and reproductive tract infections that often cannot be treated due to the lack of resources in their environment.

Moreover, in these socio-economic environments, menstruation often generates anxiety and insecurity associated with fear to the failure of the rudimentary menstruation management products. According to an estimate by the United Nations Children's Fund (UNICEF) from 2010, "about 1 in 10 African school-age girls do not attend school during menstruation or drop out when puberty starts". This is mainly due to the lack of safe and effective methods for girls to manage their menstruation and results in an inability of these females to keep up academically with their male and wealthier female counterparts.

Currently there are reusable alternatives for managing menstruation, which are used both in poor and developed countries. For example, multiple variants of reusable pads and underwear exist. They generally comprise an absorbent material sandwiched between two layers of woven textile and sometimes comprise a further layer of hydrophobic material to prevent staining or leaking. However, these pads often leak when they are saturated with menses and therefore also generate anxiety and embarrassment to the user. Furthermore, disposable and reusable pads are attached to the underwear in such a way that they are commonly displaced during normal activities such as walking or exercising. This results in chaffing, discomfort and leakage of the menses.

Tampons are worn inside the vagina and solve many of the discomfort and insecurity issues associated with pads known in the art because they are discrete and they do not move. However, tampons also leak when they are saturated with menses. Moreover, it is often difficult for the user to choose the right size of tampon for her menstrual flow and is easy to forget to remove it. Using too absorbent tampons or leaving them inside the vagina for too long can cause drying up of the vaginal mucosa and lead to vaginal infections such as vaginitis, yeast and bacterial infections or even more serious conditions such as the Toxic Shock Syndrome (TSS).

Reusable menstrual cups are safer, more affordable and reduce the risk of leak associated with disposable tampons. However, this is not a viable solution for many females who do not feel comfortable inserting devices inside their vagina for personal and/or religious reasons.

As such, described herein is a feminine hygiene device that solves the current need for an external menstrual and urinary management device that is affordable, reusable, eco- friendly, discrete, safe, comfortable and prevents leakage of the absorbed biological fluid.

Summary

In a first aspect, the present disclosure provides a reusable hygiene/sanitary device for collecting/storing biological fluid and for preventing the leakage of biological fluids onto clothing and the like. The device takes the form of a barrier, menstrual cup or catamenial sack which may be worn externally and positioned adjacent the pubic area/the vaginal opening such that biological fluids, including for example, menstrual fluids, passing out of the vagina may be caught or trapped by the device.

In a first aspect, the disclosure provides a reusable device for collecting biological fluids, the device comprising a reservoir for receiving biological fluid; and members which, in use, engage a user's thigh to hold the device in place.

The device may be self-retaining. In use, the device is configured to maintain its position relative to a user without the need for any further securing means. For example, interaction between any extending members of the device and the wearer's body parts, for example the thighs and/or buttocks, ensures that the device remains in situ.

Within the context of the present disclosure, the term biological fluid encompasses any fluid discharged from the vagina. For example, the term includes menstrual fluid, vaginal discharge, urine, semen and/or sweat.

Thus, the device of this disclosure may be worn in order to collect and/or store menstrual fluid discharged from the vagina.

When in use, the device may be secured into place by means of its members. Furthermore, the device may be used in conjunction with the user's undergarment. The user's undergarment may assist in securing the device in place. The device may be further adapted to engage or co-operate with a user's undergarment so as to secure the device in place when in use.

In use, the reservoir of the device collects, stores and/or retains biological fluid discharging from the user's pubic region. Moreover, the device prevents discharging fluid from leaking out unchecked and/or onto clothing. The device of this disclosure may be worn in order to collect, store and/or prevent leakage of menstrual fluid discharged from the vagina.

The device may be worn externally (i.e. outside of the vagina) and adjacent the vaginal opening.

Typically, a device of this disclosure is elongate, being generally longer than it is wide. The device may be curved to fit the profiles and contours of the female pubic region and/or the inner thighs. The device may be curved to fit the profiles and contours of a representative female pubic region such that the device is made to a general shape and, the device may be resilient to conform to minor variations in shape of an individual female's pubic region. The device may be shaped to extend up and engage the front of the pubic region, for example the device may be shaped to fit the profile of the mons pubis. In use, the device may extend from the front of the pubic region to engage with at least part of the backside of the user.

The device has upper and lower surfaces and in use, it is the upper surface which is placed adjacent the pubic region of the user, for example the vagina. The members which, in use engage a user's thighs, are located on either side of the device. The members may run along the edges and/or margins of the device. The members may be located towards the rear of the device such that when worn, the members engage with a rear part of the user's thighs, for example the part where the upper thigh meets the backside. The upper surface of the device may define the reservoir. The reservoir may take the form of a cavity or chamber for receiving and/or storing biological fluid. The upper surface of the device may define a reservoir opening. In use, the reservoir opening is located or placed adjacent the vagina such that biological fluid discharging therefrom may be collected and held/stored within the reservoir.

The depth of the cavity or chamber defined by the device may be constant. Alternatively, the depth of the cavity or chamber may vary along its length and/or width. For example, the cavity or chamber may present a gradient depth profile over its length and/or width. In embodiments where the cavity presents a gradient depth profile, the deepest point of the cavity or chamber may be located at one end (for example the rear end) of the cavity. In use, the deepest region of the cavity or chamber may not cover the entire pubic area. For example, in use, the deepest region of the cavity may be configured to cover only the area of the vulva and one end of the cavity may be located under the mons pubis and the other end under the perineum.

The cavity and/or chamber of the reservoir defined by the device may present a variable or gradient depth profile along its longitudinal axis. For example, one end of the reservoir cavity or chamber may be shallow and flattened and in use this end may adapt or conform to the profile of the mons pubis, providing comfort to the user. The relatively shallow end of the reservoir may then extend into a deeper portion of the cavity or chamber. In use, this deeper portion may be located adjacent the vaginal opening so as to ensure that any biological fluid discharged therefrom is collected and/or stored/held therein. Also, any fluid contacting a shallower part of the reservoir will, under gravity, be collected in the deepest part. The other end of the reservoir chamber/cavity may be shallower than the deepest part. This part of the reservoir may, in use, be located under the perineum and may prevent any leakage/spillage of collected biological fluid outside the device. The gradient depth profile of the cavity also allows for the collection of urine in the deepest portion of the cavity.

The reservoir may define one or more ribs on an inner surface thereof. The ribs may define a closed shape, that is, a shape which starts and ends at the same point. The ribs may be fluid retaining barrier ribs. In use, the ribs may prevent fluid contained within the ribs from moving outside the perimeter of the ribs. In one embodiment, the ribs are abutted ribs defined by an inner surface of the reservoir.

The reservoir of the device may define any number of ribs. The reservoir of the device may define 1 , 2, 3, 4, 5, 6, 7, 8, 9, 10 or more barrier ribs. In one embodiment, the reservoir may define three barrier ribs. The barrier ribs may define any suitable shape and size. The barrier ribs may define a circular shape, a square shape, a triangular shape, a trapezoidal shape an elliptical shape, an oblong shape, a parabolic shape, an arcuate shape and the like. In a particular embodiment, the barrier ribs define a pear shape. In embodiments where there is more than one barrier rib, the ribs may be of different sizes. In one embodiment, the device defines barrier ribs of different sizes nested into each other in a decreasing size fashion. As such, the largest barrier rib may surround the next largest barrier rib, which in turn surrounds the next largest barrier rib, etc. Therefore, in one embodiment the reusable feminine hygiene device defines barrier ribs of different sizes nested into each other in a decreasing size sequence.

As stated, the device comprises members, which engage a user's upper thigh to hold the device in place. The device may comprise two members, one on each side of the device. The members may be located on the elongate sides of the device. The members may be located towards a rear end of the device such that the members engage with the inner thigh and the cheeks of the buttocks. Furthermore, the members may run along the entire length of the sides of the device or they may cover only part of the length of the device. The two members may be symmetrical and they may be located on each longitudinal side of the device. Each member may protrude from an edge of the reservoir opening and extend outwards in opposite directions.

The members may be deformable such that in use they are configurable to mould and/or conform to the profile or contours of the user's thighs/buttock cheeks. In use, the members may grip the user's thighs.

Each thigh/buttock interacting member may comprise an extruded, deformable, resilient flap. As stated, there may be two members, one on each side of the device and extending therefrom, each designed, formed and adapted to interact and/or engage with one of the user's thighs. The members may each engage and/or interact with the user's upper thighs. Each member may extend along the longitudinal axis of the device. Each member may engage and/or interact with the user's upper thighs and the cheeks of the user's buttocks.

When not in use, the members may be biased towards a first, open configuration. Wherein in use, the members may move to a second, folded configuration. The members may move from the first configuration to the second configuration upon location of the device between the user's upper thighs. The resilient material of the members allows the deformation of the members from the first configuration to the second configuration. The bias of the members towards the first, open configuration may force the members to press against the user's upper thighs and/or buttock cheeks, maintaining the device in place. As such, the members of the device may be regarded as stabilisers that maintain the device in the correct position. Upon removal of the device, the members may move back to the first, open configuration.

In use, the device is placed between the thighs of the user, the extruded thigh/buttock interacting flaps may extend downwards from the reservoir along the secondary transverse axis of the device and they define a concave profile configured to adapt to the contour of the upper thighs of the user. In use, at least part of the device may define an inverted "U" shape. Furthermore, the extruded flaps may be profiled in a crescent shape along the plane defined by the longitudinal and secondary transverse axis of the device, to maintain a secured position against the user's thighs without restricting the user's movements. Wherein in use, the device hugs the inner thighs of the user by means of an extruded flap arrangement disposed on either side of the device along its longitudinal axis.

When the members are located towards the rear end of the device such that the members engage with the inner thigh and the cheeks of the buttocks, in use the members advantageously exert an upwards pressure which will push the device into closer engagement with the pubic area of a user.

The extruded flap members may prevent spillage of the collected biological fluid and provide an additional anti-leakage barrier to the device. Furthermore, the user may know that the device is positioned correctly when it is comfortably located between the thighs. If the device has been displaced, the user will notice this and replace the device in the correct location, thus preventing leakage.

The members may be of any suitable size and construction to secure the device in place without restricting the user's movements.

The members may extend downwards from the device and may not have first open and second folded configurations. Instead the members may take a predetermined form designed to match and fit or mate with the profile and/or contours of the upper thigh. The members may be of a general shape to fit a range of different thigh shapes, profiles and contours. The members may be bespoke shaped to exactly match the contours and/or profiles of a particular user's thighs. The members may be resilient and/or deformable such that they can conform to variations in the profile/shape of the user's thigh/buttocks. The members may further define one or more ribs, for example ribs extending longitudinally across the outer surface of each member. The ribs may be configured to be in contact with the user's inner thigh. Without wishing to be bound by theory, in use the ribs may provide additional protection against the displacement of the device, for example by gravity, by providing grip and thus preventing the device from slipping under the upper thighs of the user. Moreover, the ribs may permit the passage of air, thus avoiding direct contact of the entire surface of member against the user's thigh. This may prevent the generation of excessive sweat, which may be uncomfortable for the user and it could lubricate the device leading to its displacement. The members may define ribs of any suitable shape or form. For example, the ribs may be straight lines running longitudinally across the members. Alternatively, the member ribs may be curved, for example semi circles, running longitudinally across the members. The members may define any number of ribs. For example, each member may define 1 , 2, 3, 4, 5 or more ribs. In use, the ribs provide grip against the user's skin, assisting the members in maintaining the device in the correct position.

The device may be used together with an absorbent pad or material (referred to hereinafter for convenience as a "pad"). A pad for use may be shaped or fashioned so as to occupy all or part of the reservoir of the device. The pad may be releasably held within the device and/or the reservoir thereof.

In use, the pad may absorb biological fluid discharged from the vagina.

The pad may draw fluid away from the vagina, into the device where ultimately it is held within the pad and/or reservoir. In this way, discomfort associated with prolonged humidity and/or moisture near the skin is avoided. Furthermore, the reservoir allows for greater fluid capacity than the pad, which provides for a prolonged use of the device without leakage of the fluid outside the device.

The pad may be disposable and/or reusable.

The pad may comprise any suitable synthetic and/or natural material(s). For example, the pad may comprise one or more materials selected from the group consisting of a flannel, cotton (including soft or woven cotton), wool, hemp, terry cloth, batting, bamboo, sea sponge, luffa sponge, flax, cellulose, suede cloth, microfiber, microterry, super absorbing polymers, rayon, lyocell, olefin, polyactide, reticulated hydro sponge, microfibre towel/cloth, polyether and/or polyester.

The pad may comprise a laminate with a layer formed and adapted to provide a dry feeling to the user. For example, the pad or layer (or outer layer thereof) may comprise a funnel-type cotton net or polyester. Material of this type ensures that biological fluid discharged from the vagina is rapidly absorbed and wicked away from the user. Such an arrangement can help keep moisture away from skin and body tissues - this reduces the incidence of skin irritation/itch, urinary tract and vaginal infections. Moreover, it helps keep the pad (or a surface thereof) at least feeling dry.

The pad may be supplied in different thicknesses. One of skill will appreciate that different thicknesses may be exploited in order to cope with the amount of biological fluid that needs to be collected. Thicker pads/materials may be used where the flow of biological fluid is heavy and thinner pads or materials may be used when the flow is light or lighter. The pad may have a variable thickness with regions or areas in which the material is thicker than in others. While it is acknowledged that some women have heavier menstrual periods than others, by exploiting pads with variable absorbent properties that may easily be inserted into and removed therefrom, the device of this disclosure suits the needs of all.

As stated, in use, the pad may occupy all or part of the reservoir. For example, a pad or material for use may be dimensioned to span the entire length of the labia majora of the user. Additionally, or alternatively, the pad may be of any suitable width to ensure coverage of the distance from the clitoris to the urethra.

For example, the pad may be of any suitable thickness to provide a comfortable fit and to absorb biological fluid, for, for example up to 12 hours.

Where the pad is disposable, it can be hygienically disposed once it is saturated or if has been worn for a suitable period of time. Where the pad is reusable, the pad can be cleaned by rinsing with water and/or washing.

The pads may be sold individually or in packs. Pads of different thicknesses may be sold in one pack to suit the absorption needs of a woman during the length of a menstrual cycle. Pads of different materials may be sold to suit each user's needs and/or preferences. Moreover, the pack may further comprise a hydrophobic resalable bag to store used pads until they can be appropriately discarded or washed, avoiding spillage, odours and spread of microorganisms. The pack may further comprise one or more wash bags to facilitate the handling and washing of used pads.

The reservoir opening defined by the upper surface of the device may comprise a rim. The rim may run around all or part of the reservoir opening. The rim may be an overhang rim or overarching rim. The overarching rim may have a rounded profile. The rim may facilitate retention of a pad within the reservoir.

The rim (or an edge thereof) may further define a slot or a groove. The slot, groove or channel may extend around all or part of the perimeter of the reservoir. The slot may be defined by two spaced apart rims which run around all or part of the reservoir opening. Additionally or alternatively, the slot, channel or groove may be defined by a rim running around all or part of the reservoir opening and a surface, for example bottom surface of the reservoir of the device. Where there are two rims, one of the two rims, typically the upper rim, may over extend the other. In this way the groove, channel or slot is recessed beneath the reservoir opening defined by the upper surface of the device.

A pad for use with a device of this invention may be inserted into the slot, groove or channel defined by the device. This would ensure that the pad is securely retained in place when the device is in use.

In use, the absorbent pad is secured in place under at least a rim defined by the upper surface of the device and running around all or part of the reservoir opening. In use, the rim of the device is compressed under the pressure exerted by the user's undergarment and the natural curvature of the user's body. The absorbent pad is thus squeezed between the base of the device and the rim as a result of the compression. In use, the device may bend simultaneously in two directions, providing a pinch point on the pad at four distributed locations. The liquid retained in the absorbent pad may be drained into the chamber of the reservoir.

In use, the chamber of the device directs the excess fluid away from the body to a focused location in the chamber. The excess fluid from the absorbent pad is squeezed mainly on the pinch point and the fluid is directed to the area enclosed within the barrier ribs. In embodiments where there only one barrier rib, the fluid may be directed to the barrier rib. Once the fluid has filled the volume of the cavity created by the barrier rib, the fluid overflows outside the barrier rib to fill the rest of the chamber. In embodiments where there is more than one barrier rib, the fluid filling the first (smallest) barrier rib can sequentially overflow onto barrier ribs of increasing sizes. Without wishing to be bound by theory, the barrier ribs may provide an anti-leakage barrier by controlling the movement of the fluid, which is contained in distinct locations within the chamber. Furthermore, the barrier ribs provide the additional advantage of visually indicating to the user the amount of fluid that has been collected. This may act as an indicator of the need to empty the reservoir and/or change the pad. For example, when the fluid has filled the largest barrier rib, the user may know that is time to change the pad and/or empty the chamber. This feature may assist in preventing undesired leakage of fluid outside the device and maintaining hygiene by reducing the amount of fluid which is in proximity to the skin of the user. Once the reservoir is full, its contents can be emptied together with waste water. For example, the biological fluid collected in the device may be disposed in the toilet.

The reusable wearable device may be used in combination with an undergarment. Within the context of the present disclosure an undergarment can be any form of lower body underwear such as knickers, panties, briefs, bikinis, boyshorts, tangas, thongs, hipsters, g-strings, and the like. Wherein in use, the lower surface of the reservoir of the device is placed on the inner surface of the garment and the members are located on either side of the undergarment's leg openings.

Furthermore, the device may further comprise a fastener to clamp the device to the undergarment. The fastener may comprise an arrangement of flaps extending from the device, typically a lower surface thereof. The fastening means may comprise a button-and-loop closure, a hook-and-eye closure, a hook-and-loop closure and the like.

The fastener may comprise a push fit or interference fit arrangement. In one embodiment, the fastening means comprises a male feature on the top surface of one of the fastening flaps and a female feature on the other flap. The male feature may be a protrusion of any shape and size. The female feature may be an aperture and/or hole defined on the fastening flap. The female feature of one flap is configured to receive the male feature of the other flap. The fastening flap bearing the female feature is, in use, folded over the fastening flap bearing the male feature. The male feature may fit in the aperture defined by the female feature and reversibly close the fastening means. The fastening means may be clamped around the undergarment or it may clamp the undergarment between the two fastening flaps.

In another embodiment, the fastener comprises a push fit or interference fit connection defined between the lower surface of the device and the extruded flaps. For example, the lower surface of the device may define one or more male features such as an abutment that fit into a receiving feature (such as a female feature) located on the flaps. In use, the device is located on the inner surface of the user's undergarment and the extruded flaps are folded over the outer surface of the undergarment. Upon closure of the fastener, the device is securely located and the undergarment is clamped by the fastener.

In another embodiment, the fastener comprises one or more attachment means, each of which forms an interference fit between an undergarment and the device. For example, the attachment means may be in the form of a groove, channel or slot for the insertion of a portion of an undergarment. The attachment means may be positioned at any location on the device. It should be understood that any groove, channel or slot may grip the undergarment fabric placed or forced therein.

Advantageously, the fastening means may clamp or secure the device to the undergarment of the user to prevent the device from shifting across the surface of the undergarment or tilting. This feature, in combination with the members which engage the thighs, ensures that the device is stable in use. In this way, the device is also able to adapt to the movements of the body without being displaced and so as to prevent leakage of the collected fluid, chaffing and/or rubbing, which are typically associated with the displacement of menstruation management devices attached to undergarments.

The fastening means may be of any suitable size to allow for an accurate overlap space between the fastening flaps to clamp the undergarment between the fastening flaps.

The device of this invention may be configured to be breathable. For example, the device may comprise, consist essentially of or consist of a breathable material. The device may comprise regions of a breathable material. Alternatively, or in addition, the device may comprise regions having perforations or defining holes to allow for breathability. Breathable regions defining holes, may further allow parts of the user's body/flesh to protrude through, further enhancing the stability of the device in situ.

The device of this invention may comprise, consist essentially of or consist of a resilient, reusable material impermeable to biological fluid. The material may further be hydrophobic to ensure that no biological fluid escapes the device, while being air permeable, to allow the device to transpire. This feature may provide greater comfort to the user and reduce the odours associated with the biological fluid. The reusable device may comprise at least one material selected from the group consisting of: rubber, latex, soft vinyl, regular silicone, soft silicone, medical grade silicone, plastic, thermoplastic elastomer and/or polyethylene.

Without wishing to be bound by theory, the reusable device described herein may provide effective and reliable protection against the soiling of garments by the leakage of the body fluids collected in the device as the user moves. This may enhance the user's confidence to perform the daily movements and even sport activities.

After use, the reusable device may be cleaned with soapy water and it may be disinfected by placing it into boiling water for a period of time. The various features of this device may be integrally formed such that the device is a single unitary unit. Alternatively, one or more of the features described herein may be separately formed and attached to the device.

In a second aspect, the present disclosure provides a kit comprising a reusable hygiene device according to any aspect of the present disclosure and a pad or multiple pads for use in combination with the wearable device.

The kit may also comprise a hydrophobic resalable bag to store used pads until they can be appropriately discarded or washed. The kit may also comprise a bag or case for storing the device and/or one or more wash bags to for handling and washing used pads. The kit may further comprise instructions for use.

Brief description of the drawings

The present disclosure will now be described in detail with reference to the following figures, which show:

Figure 1 : Side plan view of a device according to an embodiment of this invention. Figure 2: Bottom plan view of the device shown in Figure 1 ;

Figure 3: Front plan view of the device shown in Figures 1 and 2;

Figure 4: Top plan view of the device shown in Figures 1 -3.

Figure 5: Isometric (perspective) view of the device shown in Figures 1 -4.

Figure 6: Isometric (perspective) view of the device shown in Figures 1 -5 with a located pad component.

Figure 7: Exploded isometric (perspective) view of the device and pad component shown in Figure 6;

Figure 8: Isometric (perspective) view of a device according to a further embodiment of this invention.

Figure 9: Bottom isometric (perspective) view of the device shown in Figure 8;

Figure 10: Cross sectional view through line a-a' in Figure 8 of the device shown in Figures 8 and 9.

Figure 1 1 : Exploded isometric (perspective) view of the device of Figures 8-10 with a pad component.

Figure 12: Isometric (perspective) view of a device according to a further embodiment of this invention.

Figure 13: Front view of the device of Figure 12 in use.

Figure 14: Back view of the device of Figure 12 in use.

Detailed description Figure 1 shows a side view of a device 10 according to an embodiment of this invention. Device 10 is a reusable feminine hygiene/sanitary device for collecting/storing biological fluid, including menstrual fluid, and preventing leakage of said collected biological fluid onto clothing and the like.

Device 10 is generally oblong in shape and comprises a reservoir 12 for receiving biological fluid and members 16a and 16b (16b not shown in this Figure), which, in use, engage a user's thighs to hold the device in place. Device 10 is intended to be located between the user's legs, adjacent the vagina in order to collect menstrual fluid or other biological fluids discharging from the vagina and/or the pubic region. Device 10 is therefore an externally (extra-vaginal) worn feminine hygiene device configured to collect biological fluid such as menstruation fluid and prevent its leakage outside the device.

The device 10 may be used on its own or it may be used in conjunction with the user's undergarment(s) in order to further secure the device in place.

The device may be manufactured in a resilient, reusable, fluid proof, material impermeable to biological fluid. For example, the device may be manufactured in medical grade silicon, which is a flexible and durable material, impermeable to biological fluids and biocompatible.

Figure 1 shows that the device has upper 2 and lower 4 surfaces. In use, upper surface 2 is located adjacent the vagina. In embodiments in which the device is used in conjunction with an undergarment, lower surface 4 is placed on an inner surface of the user's undergarment and members 16a and 16b (again not shown in this Figure) extend through leg openings of the undergarment.

Upper surface 2 defines a series of protrusions 18a which run along part of the edge of upper surface 2. In use, these protrusions are in contact with the skin of the user and ensure increased grip to prevent the displacement of device 10 in response to the user's movements. Furthermore, protrusions 18a reduce the overall contact between the user and upper surface 2 of device 10 - this provide greater breathability and air circulation and helps reduce the risk of injury (chaffing and the like) and/or infection through prolonged use.

Clearly shown in Figure 1 is member 16a. There is a corresponding member (16b) on the other side of the device but this is not shown in Figure 1 . In use, member 16a is directly in contact with the user's left thigh. Member 16a protrudes or extends from the left edge of device 10 and takes the form of an extruded, deformable, resilient flap which, in use, engages with the user's thighs to provide grip and to prevent the displacement of the device from its intended location.

When not in use, and as shown in Figure 1 , member 16a (and 16b) may lie substantially in the same plane as upper surface 2. In use and when device 10 is located between the legs of a user, member 16(a) (and 16b) is forced downward so that upper surface 6 of member 16a (and the corresponding upper surface of member 16b) is in contact with the inner thigh of the user. In use, member 16a (and 16b) deforms so as to define a generally concave profile configured to adapt to the profile and contour(s) of the inner upper thigh of a user. When not in use, member 16a (and 16b) returns to lying substantially in the same plane as the upper surface 2 of device 10.

In use, member 16a (and 16b) also provides an anti-leakage barrier that prevents the spillage of any collected fluid outside device 10.

As shown, member 16a comprises or defines ribs 20, which extend in a curved shape across part of the upper surface 6 of member 16a. Similar ribs are provided on member 16b but are not shown in this figure. Ribs 18 provide additional protection against the displacement of device 10 in use. For example, ribs 18 may help prevent device 10 from dislodging during user movement and/or slipping along the length of the user's thighs under gravity. Moreover, ribs 18 reduce the overall contact between the users thighs and device 10 and facilitate the flow of air to help reduce chaffing and infection through prolonged use. Ribs 18 and the resulting increased air flow may also help reduce the production of sweat, which is uncomfortable for the user and may lubricate the device contributing to its displacement.

Figure 1 also shows part of fastener 22a, which is best shown in Figures 2 and 3. Fastener 22a is generally centrally located on the lower surface 4 of device 10. Faster 22a extends from lower surface 4. Not shown is an identical fastener 22b also extending from lower surface 4 and positioned symmetrically on the other side of the device 10. The structure and function of fastener 22a is described in more detail below.

Figure 1 further shows part of reservoir 14 defined by upper surface 2 of device 10. Reservoir 14 is not clearly shown in this Figure and therefore the structure and function of this feature is discussed in more detail below.

Figure 2 is a bottom view of device 10. Shown in this figure are both members 16a and 16b each provided with a upper surface 6 which defines ribs 20. Best shown in this Figure are the features of lower surface 4 of device 10. Fasteners 22a and 22b are both shown extending from lower surface 4 of device 10. The fasters 22a and 22b are located on either side of device 10 and generally in centre of the longitudinal sides of the device 10 and underneath members 16a and 16b respectively. Fasteners 22a and 22b are part of a fastening system further comprising components 24a, 24b, 26a and 26b.

Fasteners 22a and 22b can be bent in towards lower surface 4 of device 10 such that parts 24a and 24b can engage and interact with parts 26a and 26b respectively. The fastening system defined by parts 22a, b, 24a, b and 26a, b is an interference or push fit system. Parts 24a, b can be pressed onto parts 26a, b which take the form of studs which releasably fit into apertures defined by parts 24a, b. As explained above, an inner surface of a user's undergarment may be paced against lower surface 4 of device 10. In such an arrangement, studs 26a and 26b may be felt through the material of the undergarment and parts 24a, b brought down and pressed thereon thus trapping the undergarment with the components 22a, b, 24a, b and 26a, b of the fastening system. This way, device 10 becomes releasably secured to a user's undergarments.

Figure 2 also shows a domed area 14 of the lower surface 4 of device 10. This domed area is part of the reservoir 12 (not shown) defined by the upper surface 2 of device 10.

Figure 3 is a front view of device 10. In this figure it can be appreciated that the front portion of device 10 extends generally upwards and the domed area 14 of lower surface 4 of device 10 is located towards the rear end of device 10. Members 16a and 16b are shown folded down and underneath, fasteners 22a and 22b are shown extending from lower surface 4. Parts 24a, 24b, 26a and 26b of the fastening system described above are also shown in this figure.

Figure 4 is a top view of device 10. This figure best shows the features of upper surface 2. Upper surface 2 defines an edge, rim or lip 28 which runs around the perimeter of the upper surface of the device. Edge, rim or lip 28 defines an opening to reservoir 12 which in this embodiment takes the form of a recessed chamber having a deep section 14.

The deep section 14, or reservoir 12 defines a pear shape, being wider at one end (the rear end) than the other (the front end). The deep section 14 is configured to be located directly underneath the vaginal opening and is designed and adapted to receive and contain biological fluid. While the depth of reservoir 12 varies along the length and width of device 10. As stated the deepest portion is marked by reference numeral 14 and is located towards the rear end of the device. The front end of reservoir 12 is shallow and flattened and in use is located under the mons pubis of the user. The lack of a bulky end of reservoir 12 at the front end of the device provides added comfort to the user and renders the device discrete such that it may not be noticeable even when the user is wearing tight clothing. The rear end of reservoir 12, located (in use) under the perineum, is also shallower than cavity 14, enabling the user to sit comfortably. Furthermore, any fluid collecting in the shallower portions of reservoir 12 will, under gravity, move to the deepest portion (i.e. that defined by section 14). As such, the gradient profile of reservoir 12 ensures that the fluid is mainly contained within deep section 14.

The edge, rim or lip 28 which defines the reservoir opening is an overarching rim defining a recessed channel or space between the lower base of the reservoir 12 and the underside of the edge, rim or lip 28 (please note, for convenience, feature 28 will be referred to hereinafter as the "rim"). With this arrangement, it is possible to insert an absorbent pad (not shown) into the reservoir and secure its edges under rim 28. Thus rim 28 facilitates the retention of an absorbent pad within the reservoir.

Rim 28 further defines a plurality of "stud-like" or "button" protrusions 18a and 18b. Protrusions 18a and 18b are located such that in use, they are directly in contact with the user's skin.

Also shown in Figure 4 are the features of the base of reservoir 12 which, in addition to the defined deep section 14, further ribs 30. Ribs 30 define zones of differing size around deep section 14. In this particular embodiment, the surface of reservoir 12 defines three ribs 30. The ribs act as barriers to prevent the fluid from moving across the entire surface of the reservoir. In use, the device initially contains fluid within the deep section 14; however, as this section fills, fluid then overflows and is retained within the zone defined by first of ribs 30. As the amount of fluid collected increases, each section defined by ribs 30 sequentially fills. Should a very large amount of fluid be discharged from the vagina or collected over time, the entire volume defined by reservoir 12 may become full.

Ribs 30 not only provide some control of the region of the reservoir in which the fluid is collected, they also serve as a visual indicator of the amount of fluid collected. For example, when the fluid is only contained within the cavity marked 14, the device can be used for a longer period of time before it is emptied at a more convenient time. However, when the fluid has already filled the zone defined by second rib 30, the user will know that soon the device should be emptied. Of course, device 10 may be used with an absorbent pad located within the reservoir 12 and this will further increase the amount of fluid that can be stored and the length of time between emptying.

Figure 5 is an isometric view of device 10, showing many of the features described in Figures 1 , 2, 3 and 4 above.

Figure 5 best shows the concave profile of device 10 and reservoir 12. It also shows that most of the edges and features the device have a generally rounded profile to increaser user comfort.

Figure 6 shows an isometric view of device 10 in conjunction with absorbent pad 100, which has been inserted into reservoir 12. As shown, pad 100 substantially fills reservoir 100 and is secured in place by tucking its edges under rim 28 and into the channel of space defined between the surface of reservoir 12 and the underside of rim 28.

Figure 7 shows an exploded view of device 10 and pad 100 in a disassembled configuration. As stated, pad 100 is shaped fit within device 10 and in use is in direct contact with the user's pubic region. In use, pad 100 absorbs fluid discharging from the user's pubic region and further increases the fluid storage capacity of device 10.

Pad 100 can be a reusable pad or disposable pad. Moreover, pad 100 can comprise any absorbent material, for example flannel, cotton (including soft or woven cotton), wool, hemp, terry cloth, batting, bamboo, sea sponge, luffa sponge, flax, cellulose, suede cloth, microfiber, microterry, super absorbing polymers, rayon, lyocell, olefin, polyactide, reticulated hydro sponge, microfibre towel/cloth, polyether, polyester or combinations thereof.

Pad 100 can also comprise a laminate with an upper layer formed and adapted to provide a dry feeling to the user. For example, pad 100 may comprise an upper layer of a funnel-type cotton net or polyester. This ensures that the biological fluid is absorbed as soon as it is discharged and the humidity is wicked away from the skin of the user, thus reducing the incidence of health issues. Such as skin irritation/itch, urinary tract and vaginal infections. Moreover, it helps keep the pad (or a surface thereof) at least feeling dry.

Figure 8 shows a further embodiment of a reusable feminine hygiene/sanitary device according to this invention. This figure shows an isometric view of a device designated 200. Specifically, device 200 is for collecting/storing biological fluid, including menstrual fluid, and preventing leakage of said collected biological fluid onto clothing and the like.

Device 200 is generally oblong in shape and comprises a reservoir 210 for receiving biological fluid. Reservoir 210 defines cavity 250 which is adapted to collect and retain fluid. Also shown are members 220a and 220b (220b not shown in this Figure), which, in use, engage a user's thighs to hold the device in place. Device 200 is intended to be located between the user's legs, adjacent the vagina in order to collect menstrual fluid or other biological fluids discharging from the vagina and/or the pubic region. Device 200 is therefore an externally (extra-vaginal) worn feminine hygiene device configured to collect biological fluid such as menstruation fluid and prevent its leakage outside the device.

The device 200 may be used on its own or it may be used in conjunction with the user's undergarment(s) in order to further secure the device in place.

Device 200 may be manufactured in a resilient, reusable, fluid proof, material impermeable to biological fluid. For example, the device may be manufactured in medical grade silicon, which is a flexible and durable material, impermeable to biological fluids and biocompatible.

Figure 8 shows that the device has upper 202 and lower 204 surfaces. In use, upper surface 202 is located adjacent the vagina. In embodiments in which the device is used in conjunction with an undergarment, lower surface 204 is placed on an inner surface of the user's undergarment and members 220a and 220b (again not shown in this Figure) extend through leg openings of the undergarment.

Clearly shown in Figure 9 is member 220a. There is a corresponding member (220b) on the other side of the device but this is not shown in Figure 8. In use, member 220a is directly in contact with the user's left thigh. Member 220a protrudes or extends from the left edge of device 200 and takes the form of an extruded, deformable, resilient flap which, in use, engages with the user's thighs to provide grip and to prevent the displacement of the device from its intended location.

As shown in Figure 8, member 220a (and 220b) may lie substantially in a plane perpendicular to that of upper surface 202. Member 220a (and 220b) has a generally concave profile configured to adapt to or match with the profile and contour(s) of the inner upper thigh of a user.

In use, member 220a (and 220b) also provides an anti-leakage barrier that prevents the spillage of any collected fluid outside device 200. Figure 9 shows an isometric view of the bottom side of device 200. Device 200 presents a concave shape whereby reservoir 210 presents a gradient depth profile, being shallower towards the front and rear ends and the sides of device 200. Members 220a and 220b extend generally downwards and have a profile generally adapted to match that of a user's inner thigh. Device 200 may be used in conjunction with the user's undergarment. In use, the lower surface 204 of device 200 may be placed on the inner surface of the user's undergarment (not shown) and members 220a and 220b extend through the leg openings of the undergarment. As stated members 220a and 220b define a crescent shape and are concave in order to conform to the contours of the user's inner thighs. As explained above, the members maintain the device in the correct position, preventing displacement of the device and spillage of the collected fluid within cavity 250 defined by reservoir 210.

Figure 10 shows a cross section of device 200 through line a-a' shown in figure 8. In this figure is can be seen that upper surface 202 of reservoir 210 defines a perimeter rim 240 which itself defines an opening to reservoir cavity 250. Furthermore, it can be seen that there is a slot or space 240a between the lower surface of rim 240 and the base of cavity 25 into which the edge of a pad may be located to secure it within the cavity 250 of reservoir 210.

Figure 1 1 shows an exploded view of device 200 and pad 300 in a disassembled configuration. Pad 300 is configured to be located within cavity 250 of the device and tucked under rim 240.

This figure also shows the generally curved shape of the reservoir, which enables biological fluid collected within cavity 250 to be primarily maintained within the deepest portion of cavity 250.

Figure 12 shows a further embodiment of a reusable feminine hygiene/sanitary device according to this invention. This figure shows an isometric view of a device designated 300. Specifically, device 300 is for collecting/storing biological fluid, including menstrual fluid, and preventing leakage of said collected biological fluid onto clothing and the like. Figures 13 and 14 show device 300 in position on a user.

Device 300 is generally oblong in shape. The device 300 has a front portion 306 which is shaped to extend up in front of the pubic region to engage the mons pubis (as illustrated in Figure 13). The front portion 306 may define holes 306a, 306b shown by the dashed lined region of Figure 12. Holes 306a, 306b allow for breathability of the device. Without wishing to be bound by theory, when the device is in use, skin from the mons pubis will extend through the holes 306a, 306b thus providing a more secure fit to the user. Holes 306a, 306b may alternatively be in the form of perforations created in the front portion 306. Alternatively, the front portion 306 may be formed from a breathable material.

Device 300 comprises a reservoir 310 for receiving biological fluid. Reservoir 310 defines cavity 350 which is adapted to collect and retain fluid.

Also shown is member 320a (an identical member 320b extends from the opposite side of device 300, shown in Figure 14). Members 320a and 320b, in use, engage a user's thighs and buttocks to hold the device in place (Figure 14). Device 300 is intended to be located between the user's legs, adjacent the vagina in order to collect menstrual fluid or other biological fluids discharging from the vagina and/or the pubic region. Device 300 is therefore an externally (extra-vaginal) worn feminine hygiene device configured to collect biological fluid such as menstruation fluid and prevent its leakage outside the device.

Device 300 is self retaining and effectively becomes clamped or held between the mons pubis and rear thigh/buttock region as shown in Figures 13 and 14 and by virtue of members 320a/b (and their interaction with the rear upper thigh/buttock) and front portion 306 (which grips the mons pubis).

The device 300 may be used on its own or it may be used in conjunction with the user's undergarment(s) in order to further secure the device in place.

Device 300 may be manufactured in a resilient, reusable, fluid proof, material impermeable to biological fluid. For example, the device may be manufactured in medical grade silicon, which is a flexible and durable material, impermeable to biological fluids and biocompatible.

Figure 12 shows that the device has upper 302 and lower 304 surfaces. In use, upper surface 302 is located adjacent the vagina. In embodiments in which the device is used in conjunction with an undergarment, lower surface 304 is placed on an inner surface of the user's undergarment and members 320a and 320b extend through leg openings of the undergarment. Members 320a and 320b are located at a rear end of the device 300 such that in use, the members engage with a user's thigh and cheeks of a user's buttocks. The engagement of members 320a and 320b with the cheeks exerts an upward pressure on the device 300 thus pushing the device into closer engagement with the user.

Device 300 has two additional members 330a, 330b located on each longitudinal side of the device. Members 330a and 330b, in use, also engage a user's thighs. Some or all of members 320a, 320b, 330a and 330b have attachment means in the form of clip 322 which provides interference fit with a portion of an undergarment when the portion of the undergarment is inserted into the grooves 322. The portion of the undergarment will normally be the hem of the undergarment.

The device 300 may be configured for use with a pad, if desired by the user. In

Figure 12 it can be seen that the upper surface 302 of device 300 defines a perimeter rim 340 which itself defines an opening to reservoir cavity 350. Similarly to previous embodiments of the device, there is a slot or space between the lower surface of rim 340 and the base of cavity 350 into which the edge of a pad may be located to secure it within the cavity 350 of reservoir 310.

To avoid repetition, other features described above in relation to device 10 and device 200 are also applicable to device 300.

The present disclosure also provides a reusable wearable device constructed, and arranged substantially as described with reference to and as illustrated in the accompanying drawings.

Those skilled in the art will recognise that the above-described embodiments are merely exemplary of the present disclosure and that various modifications and improvements may be made thereto without departing from the scope of the disclosure. Furthermore, the various embodiments described above include a number of different features. It will be recognised by those of skill in the art that many of these features offer advantages independently of the other features present in the embodiments and could be incorporated in other aspects of the disclosure.

Claims

CLAIMS:

1 . A reusable hygiene device configured to collect or store biological fluid, the device comprising

a reservoir for receiving biological fluid; and

members which, in use, engage a user's upper thigh and/or buttock to hold the device in place.

2. The device of claim 1 , wherein the device is self retaining.

3. The device of claim 1 or 2, wherein the device is further configured to cooperate with the user's undergarment so as to secure the device in place.

4. The device of claims 1 -3, wherein the device is worn externally and positioned adjacent the vagina and it is configured to collect biological fluids discharging therefrom.

5. The device of any preceding claim, wherein the device is curved in order to fit the profiles and contours of the female pubic region and/or inner thighs.

6. The device of any preceding claim, wherein the reservoir defines a cavity or chamber configured to store biological fluid discharging from the user's pubic region.

7. The device of claim 6, wherein the cavity or chamber defines a gradient depth profile along its longitudinal axis.

8. The device of claim 7, wherein the deepest portion of the cavity or chamber is configured to be located adjacent the vaginal opening.

9. The device of any preceding claim, wherein the device comprises two members each member protruding from one side of the device.

10. The device of any preceding claim, wherein the members are deformable and configurable to mould and/or conform to the profile of the user's thighs and engage with the user's thighs and/or buttocks.

1 1 . The device of any preceding claim, wherein the members comprise extruded, deformable flaps comprising a resilient material.

12. The device of any preceding claim, wherein not in use the members are biased towards a first, open configuration and wherein in use the members are moved to a second, folded configuration.

13. The device of claim 12, wherein in use, the bias of the members towards the first, open configuration is configured to force the members to press against the user's upper thighs and/or buttocks so as to maintain the device in place.

14. The device of any preceding claim, wherein in use the members define a concave profile configured to adapt to the contour of the upper thighs of the user.

15. The device of any one of claims 1 -14, wherein the members are formed, adapted and configured to interact with and adapt to the contours of, the rear of the upper thigh and the base of the buttock cheeks.

16. The device of any one of claims 1 to 1 1 , wherein the members take a predetermined form designed to match and fit the profile and/or contours of the user's upper thigh.

17. The device of any preceding claim, wherein the upper surface of the device defines an opening comprising a rim around all or part of the reservoir opening.

18. The device of claim 17, wherein the rim further defines a slot, groove or channel around all or part of the perimeter of the reservoir.

19. The device of claim 18, wherein the slot, groove or channel is configured to releasably receive an absorbent material or pad.

20. The device of claims 18 or 19, wherein in use, the rim of the device is configured to be compressed under the pressure exerted by the user's undergarment and the natural curvature of the user's body and to squeeze the absorbent pad.

21 . The device of any preceding claim, wherein the reservoir defines one or more ribs on the inner surface of the chamber defining a closed shape configured to prevent the fluid contained within the ribs from moving outside the perimeter of the ribs.

22. The device of claim 21 , wherein the reservoir defines ribs of different sizes nested into each other in a decreasing size sequence.

23. The device of any one of claims 1 to 22, wherein the device comprises a fastener for releasably securing the device to an undergarment.

24. The device of claim 23, wherein the fastener comprises an arrangement of flaps extending outwards from the outer surface of the reservoir, at opposing sides of the reservoir.

25. The device of claims 23 or 24, wherein the fastener comprises a push fit or interference fit arrangement.

26. The device of claims 24 and 25, wherein the fastener comprises extruded flaps located underneath the members of the device.

27. The device of claims 25 or 26, wherein the fastener comprises a male feature on one of the flaps and a female feature configured to receive the male feature on the other flap.

28. The device of any one of claims 25 to 27, wherein the fastener comprises a male feature defined on the lower surface of the device and a female feature in each flap and wherein the flaps are configured to be folded over the lower surface of the device and pressed against the male features to close the fastener.

29. The device of any one of claims 23 to 28, wherein the fastener is configured to releasably clamp the user's undergarment to secure the device in place.

30. The device of any preceding claim wherein the device comprises a resilient, reusable material impermeable to biological fluid selected from the group consisting of: rubber, latex, soft vinyl, regular silicone, soft silicone, medical grade silicone, plastic, thermoplastic elastomer and/or polyethylene.

31 . The device of any preceding claim, wherein the device is elongated and it comprises:

a reservoir for receiving biological fluid, the reservoir defining a cavity with a depth profile and abutted ribs for preventing the flow of the collected biological fluid and a slot configured to releasably receive an absorbent pad;

deformable resilient members extending from the edges of the longitudinal axes of the device and configured to engage with the user's upper thighs and/or buttocks and to press against them to prevent displacement of the device; and

fasteners configured to clamp or secure the device to the user's undergarment by means of a push fit or interference fit.

32. An absorbent pad configured to be used in combination with the reusable device of any preceding claim.

33. The pad of claim 32, wherein the pad absorbs biological fluid discharged from the vagina and draws away the fluid from the vagina into the device.

33. The pad of claims 32 or 33, wherein the pad is disposable and/or reusable.

35. The pad of any one of claims 32 to 34, wherein the pad comprises one or more materials selected from the group consisting of flannel, cotton (including soft or woven cotton), wool, hemp, terry cloth, batting, bamboo, sea sponge, luffa sponge, flax, cellulose, suede cloth, microfiber, microterry, super absorbing polymers, rayon, lyocell, olefin, polyactide, reticulated hydro sponge, microfibre towel/cloth, polyether and/or polyester.

36. The pad of any one of claims 32 to 35, wherein the pad comprises a laminate with a layer configured to rapidly absorb and wick the fluid away from the user.

37. The pad of any one of claims 32 to 36, wherein the pad is supplied in different thicknesses.

38. The pad of any one of claims 32 to 37, wherein the pad has a variable thickness with regions or areas in which the pad is thicker than others.

39. The pad of any one of claims 32 to 38, wherein the pad is configured to be squeezed between the base of the device and the reservoir opening rim for draining the liquid retained in the absorbent material or pad into the chamber of the reservoir of the device.

40. A kit of parts comprising the device of any one of claims 1 to 31 and an absorbent pad or multiple pads of any one of claims 32 to 38.

41 . The kit of claim 40 further comprising at least one of:

a) a hydrophobic resealable bag configured to store used pads until they can be appropriately discarded or washed;

b) a bag or case for storing the device;

c) one or more wash bags for handling and washing used pads; and/or d) instructions for use.

42. A pack of pads according to any one of claims 32 to 38, wherein the pack comprises pads of different thicknesses for adapting to different absorption needs of the user during the menstrual cycle.

43. The pack of claim 42, wherein the pack contains pads of different materials according to the user's preference.

44. A reusable feminine hygiene device, an absorbing pad, a kit or a pack substantially as described herein and shown in the figures.