TECHNICAL HELD

The objective of the present invention is related to menstrual management using an intravaginal devise that allows blood collection and emptying without its removal.

BACKGROUND ART

Menstrual cups are a well know alternative to sanitary pads and tampons in menstrual management. There are many different versions in the market, but nonetheless based on the original art by Chahner’s disclosure (US2089113) in 1935. Despite its convenience of reusability and reasonably good containment of menstrual blood, it is springy and bulky, even in a folded state, to be inserted into the vagina, and messy to be removed from vagina for periodic emptying throughout the day. While to date there are still no new ways to solve the bulkiness issue, attempts have been made to solve the emptying problem by adding an emptying stem to the cup (US5827248). However, for the emptying stem to be readily manipulatable for occlusion and intermittent drainage, it needs to protrude substantially outside the introitus, which may cause considerable discomfort when placed in between the sensitive vulvae and labia and underwear. For this reason, the emptying stem is typically short and hidden inside the vagina, which can make the manipulation difficult and, indeed, bloody messy. Furthermore, due to the stem’s small diameter, menstrual clots often block the flow through it. There is therefore a need for an intravaginal menstrual management device that has a genuinely small dimension for easy insertion and removal without the need of intravaginal finger manipulation, a distal menstrual blood emptying means that is comfortable to be worn inside the underwear while providing a wide unimpeded blood emptying without its removal from vagina.

SUMMARY OF THE INVENTION

The objective of the present invention is to provide an intravaginal menstrual management device comprising a proximal flexible ring with a distal elongated membranous tube that extends substantially beyond the introitus. This novel design takes into the considerations of the unique anatomy of the vagina and the needs of easy insertion and removal of the device while making sure that the device stays well in the vagina during use. Because when the ring is in a transverse position relative to the long axis of the vagina, it is more difficult to remove than when the ring is in a longitudinal position, it is desirable that the ring is inserted and removed in a longitudinal position, and it is kept in vagina in a transverse position for blood collection. In order to achieve this, an novel applicator is also disclosed in the present invention. The flexible ring, which is substantially annular, can be compressed radially inwards into a small double rod-like configuration comprising a proximal and a distal loop, preferably by using a cylindrical applicator, so that it can be easily inserted and removed longitudinally in and out the vagina. Inside the vagina, the ring springs open to encircle the cervix allowing collection of menstrual blood. So, in practise, the bulk of the devise is just a double rod as opposed to a cup.

The distal membranous tube is made of a thin, soft, flaccid, and flexible latex or polymeric material. It lines the vaginal wall to divert the blood for distal emptying without the removal of the proximal ring from the vagina. Due to its light and flimsy texture, it can be comfortably placed between external genitalia and underwear. In contrast to menstrual cup, the tube in this form can readily be occluded by folding, twisting, or tying. There may be a resealable tube occluding means to further strengthen the tube occlusion, such as a clip, band, zip locking and so on, to allow opportune emptying of the menstrual blood. Additionally, the thinness of the tube membrane also enables better sensation of fullness of the content in the tube to alert the user of the need for blood emptying, as opposed to the thick walls in the menstrual cups that impede such sensation. The distal end of the tube, which dangles outside the introitus, can be used to remove the device by simple tugging, thereby avoiding unhygienic intravaginal fingering as seen in menstrual cups. In this regard, for easy identification of the distal opening of the tube, a reinforced rim may be provided at the edge of the opening.

There may be a few preferred designs of the ring, which can be an annular rod, a tubular band (such as one seen in a wrist band) or a compressible corrugated tubular band. A widened band may provide better anchorage in vagina but at the expense of difficulty in insertion and removal due to the increased bulkiness. Such bulkiness may however be offset by making it corrugated and compressible like an accordion.

The membranous tube may be in several shapes. One being a straight tube in a single diameter. The others are tapering shape and funnelling shapes, both having a smaller distal diameter. In the case of the funnelling shape, the distal smaller part of the tube may be centrally or peripherally placed. Specifically, tugging the peripherally placed distal tube can cause the ring to tilt for it to be removed longitudinally instead of transversely.

While the ring is typically transversely aligned to the membranous tube, it can also be aligned in an angle to the tube. The angulation increases the volume at the proximal part of the tube and facilitates the removal process as tugging on the external part of the tube causes it to be tilted for it to be withdrawn longitudinally. The present invention also comprises an applicator to facilitate atraumatic insertion and removal, especially in the sexually naive users whose introitus is small, while ensures a proper placement of the device in the vagina. The applicator comprises a hollow barrel with a plunger with external markings. During application, the ring is radially inward-compressed and inserted wholly or partially into the barrel. The barrel is then inserted all the way into the vagina to reach the posterior fornix, and the plunger is depressed to release the ring. With that, the ring springs open with its proximal loop caught in the posterior fornix and distal loop anchoring at the anterior fornix or subpubic region, thereby encircling the cervix, to divert all menstrual blood into the membranous tube. For the device’s removal, a small hook, which is smaller than the diameter of the barrel, can be attached by an appropriate means, such as screwing, to the tip of the plunger. The plunger is placed in the barrel with the hook sticking out of the barrel’s end, which is inserted into the hymenal opening to hook and pull the distal loop of the ring into the barrel prior to its withdrawal from the vagina. There may be markings on the barrel and plungers to enable easy visual and tactile recognitions of the orientations of the ring and hook for proper application and removal of the device.

BRIEF DESCRIPTION OF THE DRAWINGS

Figures 1 shows the perspective view a ring 1 with attached membranous tube 3.

Figure 2 shows the perspective view of a tubular band la with attached membranous tube 3.

Figure 3 is the perspective view of a corrugated tubular band lb with attached membranous tube 3.

Figures 4 is the front view of a ring 1 that is placed at the closed end 3a of the membranous tube 3. The proximal opening 2 of the tube 3 is through the inner rim of the ring 1. The tube 3 is laid flat anterior- posteriorly.

Figures 4.1 shows the side view of the device as in Figure 4, wherein the membranous tube 3 is laid flat laterally.

Figures 4.2 shows the side view of the device as in Figure 4.1, wherein the ring 1 is tilted posteriorly to face superiorly, thus creating a bulge 3c at the proximal part of the tube 3.

Figures 4.3 shows the side view of the device as in Figure 4.1, wherein the distal part of the tube 3b is sealed and cut 3d to remove a part3e of the tube 3e.

Figures 4.4 shows the side view of the device as in Figure 4.3, wherein the distal part of the tube 3b is now a narrow tube.

Figures 4.5 shows the side view of the device as in Figure 4.4, wherein the ring 1 is tilted posteriorly to face superiorly.

Figures 5 shows the sideview of the device dully deployed in the vagina 27 on a pelvic model, wherein the ring 1 encircles the cervix 23, with blood collected 26 in the proximal part of the tube 3c, and the tube 3 being twisted to prevent spillage of blood. The distal part of the tube 3b is placed outside of the vagina. Figures 6 shows the side view of the applicator in a form of a barrel 13.

Figures 6.1 shows the perspective view of the barrel 13 with marking 13c at the barrel flange 13a and another marking 13d at barrel tip 13b.

Figures 7 shows the side view of the plunger 12 for the applicator.

Figures 7.1 shows the perspective view of the plunger with makings 12c and 12d at the plunger flange 12a and plunger tip 12b, respectively. There is a tunnel 12e for the hook 11 (Figure 7.2) attachment.

Figures 7.2 shows the side view of the hook 11 as mentioned in Figure 7.1 for the removal of the device by hooking onto the distal loop Id of the ring 1 (Figure 8). There is a screw' Ila on it for attachment to the tunnel 12c at the plunger’s tip 12b.

Figures 8 shows the side view of the distal loop of the ring Id being drawn into the barrel 13 by a hook 11 that is attached 11a to the plunger tip 12b. The membranous tube 3 is crumbled up at withdrawal from vagina.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS

In a preferred embodiment of the present invention, the device comprises a flexible ring 1 with an attached membranous tube 3 (Figure 1). At deployment, the proximal ring 1 is compressed radially inward into a double rod shape. To facilitate the compression, there may be two or more opposing indentations (or grooves) on the inner surface of the ring, such that the folding occurs at the weakness points (indentations) on the ring 1. The ring 1 is inserted into the vagina longitudinally along the long axis of the vagina, and it will spring open once in place to create a tension between the ring 1 and the side wall of the vagina to ensure leak proof containment of the menstrual blood inside the ring 1 and the tube 3. The distal part 3b of the elongated tube 3, is left on the outside of the vagina (Figure 8). By twisting the distal part (i.e., the part outside the vagina) of the tube 3 in multiple turns, the proximal part 3c of the tube 3 can be occluded to contain the blood and be made to stay in twisted position with the compression from underwear. As the tube 3 is soft and membranous, it w'ill be barely noticeable by the wearer, by giving a feeling much like a thin panty liner. At emptying, the tube 3 is untwisted and straightened so that menstrual blood can drain out at a substantial distance away from the user, thus avoiding contamination of the blood on the hands, external genitalia, and its surrounding areas. The opening 4 can then be wiped dry and the tube 4 is twisted back to contain the menstrual blood until the next emptying. It should be noted that though twisting is preferred, other means of occluding the tube 3, such as banding, clip or zip locking may also be employed. The distal opening edge 4 may be reinforced with a rim for easy identification and twisting by the user. In another preferred embodiment (Figure 2), the ring 1 comprises of an elongated tubular structure lb akin to menstrual cups. The tubular design of the ring 1 ensures a transverse placement of the device along the long axis of vagina. However, since it cannot be compressed into a stick like configuration, it suffers the drawbacks of the bulky menstrual cups, requiring so called C-fold, U-fold, 7-fold or punch down fold for insertion and removal, with intravaginal manipulation and spillage at removal. However, as its distal end is joined to the membranous tube 3 as above, it still has the benefit of easy containment and emptying of menstrual blood without removal the device, while having the comfort of placement between the external genitalia and underwear.

To address the issues of bulkiness on insertion of the tubular ring 1, while still ensuring proper transverse device placement in the vagina, another embodiment (Figure 3) of the present invention is disclosed. Here the said tubular ring 1 is corrugated lb, in an accordion configuration, so that it can be compressed vertically and folded horizontally into a stick like configuration for easy insertion. The latter can again be aided by having two or more indentations on the inner surface of the ring as aforementioned.

In yet another preferred embodiment (Figure 4), the tube 3 is flattened into two layers of films with its proximal end 3a sealed closed and its distal end left open 4. The ring 1 and its opening 2 is installed at one of the films at the proximal end 3a. In this way the ring 1 is aligned parallel to the tube 3. The ring 1 can now be tilted into longitudinal position by simple tugging the distal part 3b of the tube during its removal. Furthermore, when the ring is in a transverse position in the vagina 27, there is a posterior bulge 3c (Figure 4.3) giving more rooms for the containment of blood 26 (Figure 5). The ring 1 may be manufactured in various angulations with respect to the tube 3 for the above effects according to one’s need.

In another preferred embodiment, a portion of the distal part 3e of the tube 3 is removed by sealing and cutting (Figure 4.1 and Figure 4.3), creating a smaller distal part 3b for the drainage of blood (Figure 4.4). On tilting the ring transversely (Figure 4.5), a more pronounced bulge 3c, 3d is created for blood collection. Such design has the benefit of providing an even smaller tube 3b hanging outside the vagina for comfort. It also makes the twisting of the tube easier (Figure 5), as excessive twisting of the smaller distal tube 3b will not significantly reduce the volume of the proximal bulge 3c, 3b (Figure 4.5). Furthermore, by tugging on the peripherally located smaller distal tube 3b, the ring 1 will invariably be tilted longitudinally for easy removal. With a proper insertion technique using an applicator (see below) that ensures the opening of the ring 2 is always facing superiorly, the spillage of the content 26 in the tube 3c (Figure 5) can be kept to a minimum. To ensure that the device can collect the blood 26 from cervix 23 the ring 1 has to encircle the cervix (Figure 5). A fool proof way is needed to make sure that the proximal loop 1c of the ring 1 can reach and stay at the posterior fornix. It is therefore provided in the present invention an applicator comprising a barrel 13 and a plunger 12 (Figure 6-7). The applicator not only facilitates the device insertion without finger entering the vagina and makes the device smaller and more comfortable during insertion, but also ensures the device’s proper placement in the vagina. To use the applicator, the ring 1 is compressed and inserted into the tip 13b of the barrel 13 with the distal part 3b of the tube hanging outside (Figure 8). The applicator is then inserted all the way into the vagina superior-posteriorly, and the plunger 12 is depressed when the applicator cannot go any further. When deployed, the proximal loop 1c of the ring 1 will invariably be caught in the posterior fornix with the distal loop Id placed at the anterior fornix or subpubic region 25 (Figure 5) to serve the device’s blood collecting function.

In another preferred embodiment of the applicator, both the barrel 13 and the plunger 12 have their respective markings (13 c and 13d; 12c and 12d) at their respective flanges and tips (13a and 13b; 12a and 12b). These markings indicate the orientation of the ring opening’s 2 as the ring 1 is to be inserted into the barrel 13 with its opening 2 facing the markings, which should all be aligned in a straight line. When the applicator is inside the vagina, by either visual or tactile cue on the markings the user can be sure that ring opening 2 is the right side up so long as the markings are facing up, and by inserting the applicator superior- posteriorly, the barrel’s tip 13b, and thus the proximal loop 1c of the ring 1, will always end up reaching the posterior fornix 28 for an accurate deployment of the ring 1 (Figure 5 and Figure 8). In other words, due to the anatomical relations between the cervix 23, cervical fomices 29,28, vagina 27, and the gravitating blood 26, the insertion of the ring 1 needs to be direction specific. Once the ring is in the applicator and in the vagina, only by having external markings on the applicator can the direction the ring is facing be known for a proper deployment.

To further facilitate the removal of the device, the ring 1 can be compressed into the stick-like configuration by using a hook or grasping means against the distal tip 13b of the barrel 13. In a preferred embodiment, a hook 11 is attached to the distal tip 12b of the plunger 12 at an attachment tunnel 12e with the hook’s gap lib facing the marking 12d of the plunger’s tip 12b (Figure 7, 7.1 and 7.2). To remove the device from the vagina, the applicator is inserted into the vagina with the markings, therefore the hook’s gap lib, facing anteriorly to catch the distal loop Id of the ring 1 in the hook’s gap lib, and force the loop Id into the barrel 13 by pulling the plunger flange 12a (Figure 8). Once the whole ring 1 is completely in the barrel 13, the applicator can be withdrawn from the vagina 27 without any finger entering the bloody vagina Though the ring 1 by itself is already easy to be removed longitudinally, this feature may still be welcome by those with a small vaginal calibre.