Menstrual device with pressure points and elongated removal stem

An asymmetrical menstrual device with functional pressure points that aid in the insertion, opening, and removal of the device and requires minimal contact with the device itself, as well as with the body while placing inside the vaginal canal. Major design elements support ease of placement and effective opening of the device to create a seal, while minimizing pressure in sensitive areas. Another design feature is the length, functionality, and malleability of the removal stem that can be adapted to any length up until the base of the device. These elements enable greater cleanliness, comfort, and overall ease of use.

FIELD

A menstrual device with pressure points, asymmetrical shape, elongated removal stem, and various elements that provide more comfort and ease during insertion, during wear and usage, and removal. A major part of the device is the method to apply pressure and fold the device with one hand, thereby allowing minimal contact to the device.

BACKGROUND

Menstrual cups (also sometimes referred to as “devices”) are products that are placed within the vaginal canal and allow the user to collect menstrual fluid. The materials used can vary, but should include medical grade silicone for safety and hygienic purposes. Cups can be reused for several years, pending proper care, thus reducing the overall cost and amount of waste other menstrual products, such as pads and tampons, create. Cup options have been on the rise in the marketplace, but there has been a need for designs that address discomfort, sometimes even pain, that is associated with insertion, removal, as well as difficulty creating a proper seal that diminishes the likelihood of leakage. Cups often require two hands to properly fold or pinch down the material and then put in place, and often require additional skin contact with the labia, as well as within the vaginal canal, to ensure it is properly placed with the seal of the upper ring intact. This can be problematic as placing or removing a cup can be messy and access to running water or other means to clean the cup prior to re-insertion and wash one's hands can sometimes be limited.

SUMMARY

By designing a menstrual device that is asymmetrical, it enables greater comfort and functionality during insertion and removal and reduces the possibility of leakage due to the unique integrity of the device shape that lends itself to fully opening once placed in the vaginal canal.

The disclosed design features provide a menstrual device in which comfort, functionality, and methods for insertion and removal are major elements of the overall asymmetrical shape.

The base of the device extends into an elongated stem that can be adapted by the user to their desired length to any length up until the base of the device. The elongated stem also minimizes the need for additional skin contact or possible probing inside the vaginal canal to establish the device location.

The base of the device exhibits areas with functional pressure points for collapsing the device with one hand instead of two; ensuring a full pop-open or seal of the upper ring when placed in the vaginal canal; and enabling a gentle breaking of the seal for comfort and ease of removal.

Further features, advantages and properties of the device associated with this application; will become clear in the detailed descriptions.

DETAILED DESCRIPTION

The vaginal cavity is quite adaptable and varies slightly with each individual. It is where menstrual blood exits from the cervix in various amounts for a duration, typically, of several days each month. Methods and products for menses range from absorption, with pads and tampons, to collection, with catamenial devices, now more commonly known as menstrual cups.

Menstrual cups provide a healthy and sustainable alternative to the waste accumulating one-time usage of pads and tampons. Menstrual cups can be made from silicone via a liquid silicone rubber, silicone injection molding process, and with proper care can be used for several years. However, it is challenging to find a product that has gone through the full certification and validation processes. This can impact the overall quality in available products, ranging from the materials used, to their manufacturing and post-manufacturing processes, resulting in products that may be suspect.

Menstrual cups, with increasing popularity and awareness, has become a more common menstrual solution—especially amongst those who wish to reduce waste and save money with a healthy alternative, but many are hindered by the needed body contact to place and remove the cup and fear it will be messy. To properly place a traditional menstrual cup, the user will need to pinch or press down the sides of the cup wall to collapse it and make it smaller for insertion. This, traditionally; has required contact on all outer wall surfaces of the cup and the use of two hands. Similar to a tampon, the cup is then inserted into the vaginal canal, where it will need to open, or unfold, in order to ensure a seal. The goal of the seal, which is achieved by continuous contact on the sides of the vaginal wall by the upper ring of a cup, is to prevent the possibility of leakage. Most cups will require the user to have additional physical contact of their labia as well as inside their vaginal walls to check and make sure a cup is properly placed and fully open, thereby creating the desired seal for collection. This process sometimes involves: manual examination within the vaginal cavity with a finger along all sides of the wall to check for a folded area or crease; additional cup rotation within the vaginal canal with hopes that it will eventually open fully; or other similar actions, which is more involved than many might be comfortable with, and can be messy. There is not always access to clean, running water, so this part of the process might prove problematic for some, increasing the risk of being unhygienic in those instances. Further, checking to make sure a cup is properly placed each time might take more time than some prefer. However, cups generally have a larger capacity than tampons or pads, so some users are able to go up to twelve hours between emptying their cup, thus plan accordingly and wait until they are in a more favorable location to wash their hands and empty the cup, also saving time overall due to less frequent changing demands compared to tampons or pads.

Some cups tty to avoid this additional contact inside the vaginal canal to check or manually create a seal, by designing a thick or stiff upper ring that has a stronger pop-open, but this, in turn, might be painful or uncomfortable for some users. Further, having increased pressure at the top of the cup, that is the furthest distance into the vaginal cavity, can create an undesired effect of additional pressure on the urethra and colon, creating a sensation of needing to urinate, or restricting that process. It can also create a sensation of blockage or constipation in the user when it comes to bowel movements. The female anatomy of the urethra and colon are closer in proximity to the vaginal cavity the further into the vaginal canal one goes. Conversely, there is less impact on other bodily functions or discomfort if there is rigidity or pressure closer to the vaginal opening where the spacing of the urethra and colon are further from the vaginal canal. Furthermore, when it's time to remove and empty the cup, the thick or stiff upper ring that is no longer collapsed like it was during insertion, but fully open, can cause pain for some users in that it's a much larger area that's being removed from the vaginal canal.

Most cups, while they are malleable, are symmetrical in shape, which does not take into account the overall shape of the vaginal cavity. This can create slight discomfort and awareness when a symmetrical cup is being used. Sometimes those cups go beyond discomfort and cause irritation, rubbing or rashes, soreness, bruising of the cervix, near the public bone, or other areas in or near the vaginal canal, in part, due to their symmetrical shape. It should also be noted that small holes can be seen near the upper ring of most cups, which help to maintain a balance in bodily fluids and relate to the effectiveness of the seal.

Removal of the cup to empty, clean, and reinsert if still menstruating, can require intimate contact as opposed to a pad or tampon, which can be removed with an attached string. Most cups have a base with little or no material to grasp and pull the cup down and out of the vaginal cavity. Some have a base or stem that extends to almost an inch in length and are not necessary for the overall function of the cup and can be cut or removed completely if the user desires due to having a lower cervix, or if they have sensitivity to the often abrasive material extending out from the stem to create a grip. The abrasive materials can cause friction, create discomfort, and sometimes even a rash, especially when extending from a cup base or stem that is quite substantial in material width. The stem in some cups may be covered with small “spikes” or the like, insofar that it might feel to a user like a stiff popsicle stick or straw with extending ladder rungs, or like rough sandpaper against delicate tissues. In cups with minimal or no stem at the base, the user might need to search for the cup by reaching up and into the vaginal cavity because the cup might have shifted higher or out of place during use—especially in the case of individuals who have a higher cervix. This can prove problematic, again, in cases where one can't properly clean their hands before or after, or in situations where someone might have longer fingernails, as they might inadvertently scratch themselves, or damage the cup as they try to grab hold of the cup and pull it out for removal.

Once the user has hold of the cup, due to the often stiff upper ring that is now fully open, resulting in a much larger surface area and circumference than the previously, collapsed cup for insertion, removal can sometimes create discomfort or even pain for the user. This, along with some of the many other aspects found in traditional cups described above, can deter someone from continuing usage of a cup.

Therefore, it is the aim of this present design to address prevalent limitations and provide a more comfortable, functional, and reliable menstrual device. Such design, while being more user friendly for first-time and long-time cup users, may also benefit individuals with disabilities due to a more functional and user-friendly insertion and removal process. Additionally, considering social and cultural stigmas and taboos often still surrounding menstruation, female bodies, and physical contact, this particular design may help alleviate stigmas insofar as the device requires far less physical contact for placement and removal compared to traditional cups. Further, it is of utmost importance that the material sourced and used for manufacturing has gone through extensive biological testing in order to obtain regulatory clearance for medical device usage. Manufacturing aims to meet all federal requirements and is certified, registered, and listed to produce such medical devices, which is in opposition to current market trends where products don't always follow such procedures.

The material of the menstrual device may be made from medical grade silicone. The medical grade silicone may be designed to meet Current Good Manufacturing Practice, (cGMP) standards in facilities directly or indirectly regulated by US FDA (Food and Drug Administration). The liquid silicone rubber, or LSR, is designed for liquid injection molding, or LIM, as well as overmolding, which is another production option. The present design may also minimize production waste during the LIM process since the removal stem may also function as the channel in which the LSR travels within the tool or mold when manufacturing the menstrual device. In some devices, the material range can be 40 to 70 durometers, depending on specific design, function, and desired product feel. It should be noted that the device can be made with or without a removal stem, with or without additional grips on the stem or base or the cup, from alternate materials, with alternate manufacturing processes.

It is noted that this list is not exhaustive as there may be other advantages not explicitly detailed herein. Further, the present application includes features and descriptions that can be implemented in combinations other than those explicitly, described.

A first perspective of the menstrual device is illustrated inFIG. 1. The device150has a noticeably long and slender removal stem100. Removal of the device150with the stem100should enable less probing if a user has a high cervix, or the device moves further up in the vaginal canal during wear, thus creating a safer and cleaner removal process. The existence of a removal stem is not unique per se, but this particular removal stem100is useful because it is noticeably elongated, yet remains highly flexible for increased comfort due to the stem width that does not need to be uniform in width, and can range from 1.5 mm to 6 mm. Removal stem100can be adapted to any length up until the removal bulb140or base of the device160, by cutting the stem100to the desired length of the user. In some devices, the removal stem100may comprise small bulbs120that may vary in width and function both as a grip during removal or as a unique reference110for if a user wanted to shorten the stem. The user may do so by counting the number of bulbs120from the tip of the stem100, removing the cup150from their body, then using that reference number to cut the stem100, thereby eliminating what stem100length might not be needed for their body. The stem100can range in length from 0 mm, if removed, to just under 50 mm. Further comprising, the stem100is singly molded with the base of the device in uniform material, which due to the unique length and dimensions, is useful because it creates a reusable removal stem. Alternatively, users might otherwise have to add a one-time-use string, other material, or approach that might prove less healthy or sustainable in order to create additional length for ease of access.

A second perspective view inFIG. 1, the stem100may thrther comprise of one or more removal grip rings130in the removal stem100, providing traction while also minimizing potential for friction or discomfort from rough or protruding edges. The existence of additional material or grips130is not unique per se, but this particular placement of the grips130and unique contoured shape of the grips130and bulbs120assists in removal, while limiting potential for irritation. Alternatively, the device150is manufactured without the existence of the grips130, removal stem100, and/or the removal bulb140at the base160.

In the exemplary perspective view ofFIG. 2, an upper ring200is viewed from the back, and slightly above, the cup150. The existence of the upper ring200is not unique per se, but it should be noted that the upper ring200is not uniformly within the inner diameter of a cup wall270, nor is it uniformly extending out as an outer diameter ring from the cup wall270. It should be noted that this particular upper ring200is useful because it provides needed continued contact against the vaginal wall while minimizing pressure on other bodily functions. The inner diameter of the upper ring200for the front210and back220surfaces of the device ring200extend further into the interior dimensions of the device walls210a,220b, by a range of 0.5 min to 6 min. The right230cand left230bsides of the upper ring200extend outwards from the walls250c,250b, anywhere from 0.5 mm to omin. The existence of the upper ring200extending outwards from the cup walls270is not unique per se, but this particular extension of the ring200outwards from the device wall270is substantial enough to assist in creating a seal when placed within the vaginal cavity, while not extending out in width to the point of creating intense pressure or rigidity due to excessive material volume dimensions. Further comprising, the upper ring200, does not uniformly extend inside210a,220b, from the walls270, nor outwards230b,230c, from the walls270as other devices, but this particular ring200design is useful in that it reduces or eliminates undue pressure, bruising, soreness, or discomfort due to a malleable and minimal material dimension that eliminates what is typically a stiff upper ring. It should be noted that the upper ring200at the front facing side210may reduce pressure in areas such as the urethra.FIG. 13,FIG. 14, while the back side220, may reduce pressure on the colon due to being more flush with the cup walls270. Alternatively, the upper ring200may uniformly extend inside the cup walls, or outside the cup walls270.

In the exemplary perspective view ofFIG. 3, the small removal bulb140at the base of the device160provides a place to hold securely and pull to remove the device150. Further comprising, pulling anywhere along the elongated stem100or removal bulb140downwards, or from side to side can break the seal of the upper ring200and ease removal. Further, from this perspective view, the front side of the upper ring300is noticeably lower than the back side of the upper ring310. This is due, in part, to a shorter front wall350, which is unique in that during removal, the shorter front wall350assists in breaking the seal of the upper ring200, thereby minimizing prolonged suction or discomfort. Further, the shorter front wall350provides greater comfort to the user during removal as it allows more flexibility as the now fully opened upper ring200is pulled out from the vaginal canalFIG. 14. It should be noted that from this perspective view the sides230b,230cof the upper ring200visibly protrude outward from the cup walls250b,250c.

In the exemplary perspective view ofFIG. 4, an internal spine400extends from the base of the device160up the inside wall440of the front side of the device350. Alternatively, the internal spine400can, but does not need to, extend the full length of the device410. This is in part due to the slight dip in the front of the upper ring300, which assists in creating a crease, fold, or “hinge” when pressure is applied to the front wall350, as demonstrated inFIG. 8. The internal spine400assists in the device150folding with pressure applied in one or more locations on the device front wall350, as demonstrated inFIG. 7throughFIG. 12. Further comprising, the internal spine400assists in the device150fully opening, once placed inside the vaginal cavityFIG. 14, from the collapsed positioning, as demonstrated inFIG. 10throughFIG. 12.

Alternatively, the internal walls440of the device150remain substantially smooth, without the presence of an internal spine400or additional material protruding in width.

In the exemplary perspective view ofFIG. 5, the front outer edge of the upper ring540, and back outer edge of the upper ring550are more flush with the cup walls230f,230g. The front540and back550upper ring extends between 0.05 mm and 5 mm outwards from the device walls230f,230g. The upper ring200has minimal volume of material in order to reduce the amount of pressure in the upper extremities of the device, which is useful because anatomically, the distances between the urethra, vaginal canal, and colon are closer together the further up you go from their openings, so less pressure at the top of the device,540,550,200is desired to reduce pressure on other organs and bodily functions. The upper ring200ranges from 2 mm to 7 mm in width. Further comprising, the specific aspects that are unique in the functioning of the upper ring200are that it applies less pressure to critical areas in the front540and back550of the device to the urethra and colon due to being more flush with the device walls230f,230g, thus distributing the pressure instead of intensifying it.

A second perspective view ofFIG. 5, the internal spine400and asymmetrical, as demonstrated inFIG. 5, device shape500assist the device fully opening once inside the vaginal cavity. This particular design is useful because the upper ring200,300, asymmetrical device body500, internal spine400, individually, or in concert, helps to create an effective seal. The specific aspects unique in their functioning are that they can eliminate the need for increased skin contact to manually facilitate the device opening fully. Further comprising, this particular design is useful because it can eliminate the uncertainty or guesswork that even the most experienced cup users exhibit as to whether an effective pop open or seal was created.

A third perspective view ofFIG. 5, the asymmetrical shape500results in the device opening fully with integrity, and not relying on a stiff upper ring200for holding its shape within a constricting space. Further comprising, having a device body500with increased integrity and strength due to the asymmetrical shape500also eliminates the need for a drastic pop-open, or opening of the of the device upper ring200, which in this particular design is useful because it reduces the potential for pain, bruising, or soreness in users. Further comprising, it minimizes the intensity of the suction from the seal when removing the device.

A fourth perspective view ofFIG. 5, a pressure point570within the lower third of the device front wall350allows for one-handed folding of the device and can eliminate the need for handling and touching upper regions of the device500to create a fold, as demonstrated inFIG. 7throughFIG. 12, that collapses the device walls and concentrates the device circumference so as to prepare for insertion into the vaginal canal,FIG. 10throughFIG. 12. Further comprising, the asymmetrical device500also curves580towards the base160from near the pressure point570. This particular curvature580near the pressure point is useful because it helps the user to identify the front side of the cup350from near the base160, the location of the pressure point570, as well as conforms to contours within the vaginal wallFIG. 13andFIG. 14. Further comprising, the curvature580minimizes potential for bruising or soreness of pressure placed against the pubic bone, but instead, due to complimentary contours, further assists holding the cup in placeFIG. 14. It should be noted, that the curvature580also enables users to identify from just above the base160when placing the device where the front facing wall350is located due to the slender curve580as opposed to the more bulbous curve of the back side510, which due to it's shape and placement within the vaginal cavity, enables significant collection of fluids.

A fifth perspective view ofFIG. 5, the removal bulb140in this particular device is placed forward of the cup center line590, and angled forward as if towards the user's toes when standing, not directly downwards and parallel to the cup center point590. This unique placement is useful in that it better conforms to anatomy and compliments contours. Further comprising, the angle160enables effective stem100placement for function, providing logical placement for removal in that the stem100goes towards the vaginal opening, which increases comfort as well since the stem material isn't probing into the vaginal canal or into the labia. Similar to how a user using a tampon would need to insert it towards their lower back, and not directly up and towards their head, so too with a menstrual cup, hence the particular asymmetrical location for the removal stem160, bulb140, and angle of the stem100. Further comprising, the unique stem placement not only creates a reference as to the cup placement and location, but also enables the cup to stay in place properly, as opposed to traditional cups that sometimes migrate or move out of position, thus causing discomfort or leaking. Further comprising, placement of the stem slightly forward not only simplifies the location for grabbing hold of the stem and base of the cup, but potentially benefits individuals with reduced mobility as well in that placement slightly forward means not having to reach back as far as traditional stems that are positioned and angled directly down.

A sixth perspective view ofFIG. 5, the upper ring520, forward of the cup center line590, is sloping towards the front300, creating an asymmetrical and sloping upper ring200resulting in a higher height in the back wall310of the device than the front wall350. Further, the lower front wall350and ring520of the device results in less material and device circumference when folding the device500in preparation to insert, as is visible inFIG. 11, enabling greater ease and comfort for the user when placing the device. Further comprising, this particular design is useful because with the shorter front wall350and the asymmetrical upper ring520, less pressure570is required to create the fold and collapse the device, thereby enabling the option of using the device with just one hand, as well as eliminating the need to touch additional areas of the device. Further comprising, the upper ring540material shifts further towards the inner wall210, thereby is further usefid in that it creates an easier “hinge” or crease for the fold when pressure is applied570as there is less material that might otherwise bunch and create resistance at540.

A seventh perspective view ofFIG. 5, the unique shape500which allows for substantial volume of menstrual fluid collection, retains the integrity of the device shape, yet conforms to natural bodily contours510,580,160. The overall shape of the device body500ensures wall integrity and comfort with its asymmetrical shape500. This particular asymmetrical shape500, is useful because the front facing wall350has the slight curvature580that connects to the base160, while the back wall510is more bulbous, with curvature that conforms to the female anatomy. Further comprising, the angle of the upper ring520assists users who may have a lower cervix, thereby possibly, eliminating: potential disruption of proper placement within the vaginal canal; interference with the device fully opening; or possible bruising of the cervix. Further comprising, the removal bulb140has the option to be asymmetrical with less material protruding on the front facing side140ain order to be more flush with the vaginal wall, thereby potentially further reducing any pressure.

In the exemplary perspective view ofFIG. 6, the two points600a,600babove the device base160, equidistant from the front of the device350, can be pressed or pinched together in order to assist the device fully popping open, if needed, to create the seal of the upper ring200. The existence of these unique pressure points can be useful if the device does not fully open upon initial placementFIG. 14, because, for example, the user has a tighter vaginal cavity. In which case, the pressure points600a,600blocated in the lower quarter of the device150, can have pressure applied from opposite sides to facilitate opening of the device. This specific aspect is unique in the functioning because it encourages the desired opening of the device with minimal guesswork or contact further up the device and into the vaginal canal to check that the seal200is fully intact. Further comprising, the user can determine if the device is fully open from base620, as opposed to having to reach further into the vaginal canal to manually determine this, due to the fold, as demonstrated inFIG. 10, that the user can feel at the front base620of the cup150. Further comprising, the removal stem160has the option of being asymmetrical in shape to further enable flexibility of movement.

A second perspective view ofFIG. 6, if assistance is needed to comfortably and effectively break the seal200for removal, direct pressure can be placed gently near the base620of the device, which will effectively break the seal of the upper ring200. Further comprising, a user may gently guide the cup150towards the vaginal opening by pulling down or side to side on the stem100, then when the cup150is almost completely removed, holding securely at the now visible and accessible base160with the option of pressing gently on the pressure point620to break the seal. This approach is possible in part due to the elongated stem100, as well as the pressure point at the base of the cup620functioning in concert with the upper ring200to reduce the pressure and circumference of the upper ring200, thereby better controlling and minimizing potential spillage while emptying menstrual material from the cup.

A third perspective view inFIG. 6illustrates where the one or more pressure or cup seal holes640to balance bodily functions while placed inside the vaginal canal are visible near the upper ring200of the device. It should be noted that they are not a unique design feature.

In the exemplary perspective view ofFIG. 7, the device150is held in one hand with two fingers, such as the thumb and middle finger, on opposite sides of the lower third of the cup body700a,700b, and finger, such as the index finger, touching the pressure point570. Further comprising, the device150has the option of including additional grips or material near the base that extends from the device walls in order to provide additional traction while contacting the cup for collapsing, or for removal.

In the exemplary perspective view ofFIG. 8, the device150is shown with pressure applied800to the front wall350at the pressure point570, which coincides with the internal spine400. The upper ring200is shown collapsing at the front-facing, lowest point300, further assisted by the upper ring material210that extends further into the cup walls, thereby creating a hinge.

In the exemplary perspective view ofFIG. 9, the device150is shown collapsed900. Side walls700a,700bcontinue to be pressed together with the two or more fingers.

In the exemplary perspective view ofFIG. 10, the device150is shown fully collapsed10a. The fold10con the front facing side of the cup extends from the upper ring200down to the base1101), thereby enabling a user to feel and identify from the base of the cup whether it is fully open or still partially collapsed while it is placed inside the vaginal canalFIG. 14. Further comprising, in the event that the device150does not fully open, for example in a user who has a narrower vaginal canal when first inserting the cup, and the pressure collapsing the cup700a,700bis removed, the user may apply pressure on the lower portion of the cup base600a,600b, to encourage full opening of the device.

In the exemplary perspective view ofFIG. 11, the device150is shown from above in a collapsed configuration11a. Further comprising, the asymmetrical shape and shorter front wall when collapsed11bdoes not bunch material from the entire upper ring onto each other 11c, but rather is offset11din most areas, thus resulting in creating a smaller overall cup dimension when collapsed.

In the exemplary perspective view ofFIG. 1, the device150is shown fully collapsed12aand ready for insertion into the vaginal canal.

These, along with other details of this unique design, will become more apparent in the following claims and drawings. It is understood that there may be some changes to the exact structure described and shown, but they do not negate the overall spirit of the invention. Further, features described in the preceding description may be used in combinations other than the combinations explicitly described.

Whilst aiming to draw attention to features of the invention believed to be of particular importance, it should be understood that the Applicant claims protection in respect of any patentable feature or combination of features hereinbefore referred to and/or shown in the drawings whether or not particular emphasis has been placed thereon.

The term “comprising” as used in the claims does not exclude other elements or steps. The term “a” or “an” as used in the claims does not exclude a plurality. A unit or other means may fulfill the functions of several units or means recited in the claims.