VAGINAL PROTECTION DEVICE

This invention concerns a vaginal protection device, which lies against the vagina walls, when the protection device is placed in the vagina.

Background

Currently, vaginal protection devices for women are mainly known from contraceptives as e.g. the diaphragm. This known configuration is disc-shaped with a thick bulb along the edge of the disc-shaped area. The choice of material is a special rubber type with high elasticity equivalent to the demands of the medical authorities.

For the sake of the intended contraceptive effect, a diaphragm, which is normally applied in connection with spermicide, is constructed with an oversized outer circumference, ensuring the diaphragm, when in use, an oblique orientation in the vagina lying against the vagina walls with a considerable contact pressure. Conventional diaphragms are therefore not designed for use over a longer period of time, but must in most cases be removed within 12 hours after time of insertion.

Other known vaginal protection devices also comprise fluid absorbing tampons, which must also be removed rather fast for hygiene reasons.

Further, from US 3780730 a tampon-like device is known, said tampon-like de- vice being adapted for contraceptive purposes only. The product consists of a cube of an absorbing and resilient material being compressed on the centre axis by a string. The cube is inserted in the vagina - as far up as possible - in order to block the cervix of the uterus - but primarily functions by the appliance of a spermicide. This device should also be removed shortly after use for hygiene reasons.

For placement in the vagina over a longer period of time, a urinary incontinence preventing device is a known from WO 95/05790, exerting, however, a fairly high active pressure against the neck of the bladder during insertion in the va-

gina. A corresponding device for the treatment of incontinence is described in US 6470890. This device is similar to a diaphragm and is adapted to, after insertion, press against the walls of the vagina by inflating a hollow ring. Downwards the device is conical in order to encase valves and in order to permit in- flation making the device rather large and ill-suited for contraceptive purposes. Further, the device is configured of several parts which increases the price of the product significantly and makes it ill-suited for disposable use and for cleaning.

During exercise of sporting activities, such as e.g. swimming in public swimming facilities, open-air pools and the like, most women use, considering the pressure discomfort, no other form of protection than a tampon, which, due to its high fluid absorption capacity, is quickly filled by the surrounding water. Even when the surrounding water has been added disinfectants, e.g. chlorine, it most often is a carrier of micro organisms, which might cause infections of the bathing person. This is clearly seen e.g. in the form of frequent eye infections of the guests at public swimming facilities or on guests on holiday resorts at the end of the season.

A considerable number of women, especially in connection with swimming and bathing, get abdominal problems in the form of infections and thereby subsequent have an increased risk that a prolonged, untreated infection might evolve into a precancerous lesion, particularly in the cervix.

Thus, there is a need for a simple protection device, which effectively prevents infections and at the same time does not cause discomfort when being used over a longer period of time.

Objective and description of the Invention It is thus and objective of the present invention to provide a vaginal protection device without the aforementioned disadvantages.

The present invention thus concerns a vaginal protection device comprising at least one central anchoring part and at least two protruding, circumferential and

at least partly flexible sealing elements with a larger outer circumference than the anchoring device, so that the sealing elements at least partly lie against the vagina walls, when the protection is placed in the vagina.

When using this vaginal protection device an optimal adaptation to the inner vaginal contours and diameter is thus achieved, the device lying closely against the vagina walls but without the discomforting dilation of these - as occurs with known diaphragms - or the discomforting pressure against the neck of the bladder. Likewise, with two or more sealing elements an optimal and secure sealing all the way round is achieved - even with an oblique insertion of the protection device. A secure sealing is also achieved for vaginas of all sizes, even though the width of the vagina might vary rather significantly depending on how far up in the vagina the protection device is placed, or vary from time to time or maybe even change size while the protection device is in use. In particular by three or more sealing elements - in addition to the mere mechanical sealing - also a labyrinth sealing is achieved, which further secures against leakages and which is particularly advantageous in connection with walls of a relatively soft material, such as the biological tissue in the walls of the vagina. If a sealing element for unknown reasons does not lie completely up against the walls of the vagina, and thus is not completely tight, a vacuum sealing is built up in the space between the next two sealing elements which again improves and secures the sealing.

Alternative embodiments of this invention are described in the dependant claims. In a further embodiment, the sealing elements might thus be configured with contacting parts comprising a peripheral bulb or alternatively two peripheral, mutually separated flaps.

A vaginal protection device might also comprise an applicator for removal, which in one embodiment comprises a string fixed in the anchoring part.

The configuration of the protection device according to the invention facilitates easy insertion of the device into the vagina ensuring accurate placing again ensuring the desired protection against infections and/or the desired contraceptive

effect. Further, the insertion can practically be made anywhere.

This invention further relates to a protection device with the above described configuration and an applicator for the insertion of the protection device in the vagina and/or the removal of same from the vagina.

Short description of the drawing

In the following the invention will be described with reference to the enclosed figures, where

Fig. 1 shows an axial section of an embodiment of the protection device, as placed in the vagina, when using the insertion applicator,

Fig. 2 and 3 show similar axial sections of the protection device as shown in Fig. 1 and of the insertion applicator, respectively,

Fig. 4 shows an end face section of the protection device in the plane PP in Fig. 2 seen from the one end,

Fig. 5 shows examples of alternative embodiments of sealing lips on the protection device,

Fig. 6 shows an alternative embodiment in a picture corresponding to Fig. 2,

Fig. 7 shows another embodiment of a vaginal protection device according to the invention,

Fig. 8 shows an enlarged section of the contact part of a sealing element,

Fig. 9 shows an insertion and removal applicator in engagement with an anchoring part,

Fig. 10 shows the section A-A from figure 9,

Fig. 11 shows an alternative embodiment of an inflatable vaginal protection device according to the invention,

Fig. 12 shows, in larger details, the applicator from Fig. 11 in engagement with the anchoring part, and

Fig. 13 and 14 show section A-A and section B-B, respectively, from figure 12.

Description of embodiments In the shown embodiment, the protection device (1) comprises a flexible plug- like object made of known rubber or latex qualities or an elastic, deformable plastic material such as e.g. silicone rubber, pharmaceutical silicone or polyure- thane with in effect known colouring. The device (1) comprises, as shown in figure 1 and 2, a central anchoring part (2) and a lip sealing (3) comprising three sealing lips or sealing elements (4), (5) and (6) protruding from and surrounding the anchoring part (2), said sealing lips or sealing elements being, in figure 1, shown in their elastic deformed positions when inserted in close contact with the inner walls of the vagina (100), while the lips (3) in figure 2 are shown in their undeformed position. All or some of the sealing elements (3, 4, 5 and 6) have a larger circumference than the anchoring part (2) securing that parts of these at least partly lie against the vagina walls (100) when the protection device (1) is inserted in the vagina.

In regard to easy removal of the protection device from the vagina, in the in- serted position as shown in figure 1 , a removal means in the form of a string or a ribbon (7) has been fixed on the anchoring part, where said string or ribbon, when inserted as in figure 1, will protrude from the pelvic opening, facilitating easy removal after use, e.g. with a protruding length of 3 cm.

I an embodiment the protection device has no removal means but must be removed manually. The central anchoring part might also be configured with a protrusion as shown in below figures, so that the applicator can also be used for removal of the protection device.

Insertion of the protection device into position can, as shown in figure 1 , be done by means of an insertion applicator as shown in Fig. 3 comprising a push rod (8) with a proximal end (9) and a distal contact end (10) with an end tap (11).

As a bearing for the distal end (10) of the push rod (8) the central anchoring part (2) of the protection device, as in the shown example, is constructed with a recess or a hole (12) for receiving the locking tap (11) at the distal end (10) of the push rod (8).

As shown in figure 4 the protection device has, in its undeformed condition, a substantially circular outer contour of the sealing (3), but might also be designed with other contours such as elliptic, oval or the like. By the axial displacement of the flexible plug-like object (1) of the protection device, the protruding sealing elements (4-6), as shown in figure 1 , are exposed to a substantially elastic inflectional deformation to close adaption with contact against the vaginal walls, ensuring an optimal protection against migration of infection-generating microorganisms in the woman's abdomen as well as being an effective barrier against further migration of semen.

As shown in figure 5 at a) and b), respectively, one or more of the protruding sealing elements (4-6) of the protection device may preferably be designed with a circular peripheral bulb (13) in order to obtain the desired sealing effect, or alternatively with two thin peripheral, mutually separated sealing flaps (14, 15).

A simplified embodiment of the protection device (1 ) is shown in figure 6 where the lip sealing (3, 16) of the protection device is configured with only two sealing elements (17 and 18) in stead of with three lip sealing lips as shown I fig. 1-2. Hereby a good mechanical sealing is still achieved, which to a large extent will be secure even if the protection device is positioned very obliquely in the vagina just as the protection device, when in use, in this embodiment is adapted to various sizes of vaginas, dilations and contractions. Further, this embodiment will have lower production costs. However, if one of the embodiments with three or more sealing lips or elements, as shown in the other figures, is used, an even

more secure labyrinth sealing is obtained, just as the pressure of the protection device against the vagina will be more evenly dispersed over a larger part thereof resulting in less discomfort for the user.

The more accurate configuration of the protruding and circumferential sealing elements may be of various forms. What is important for this invention is primarily that they are flexible and deformable such that they lie closely against the vagina walls when in use.

When inserting the protection device the end tap (11) of the push rod (8) is inserted into the hole (12) in the anchoring part (2) and the string (7) is tightened lightly and held in position together with the push rod (8). After insertion, the push rod (8) is removed and the string (7) now appears with an optional over length, facilitating the removal of the protection device in the same way as known from i.e. tampons.

By the deformation during the insertion of the protection device the disc-shaped sealing elements (4-6) are reclined so as to adapt to the inner contour and diameter of the vagina, such that formation of wrinkles or other contours will be considered as an integrated whole ensuring a total sealing without notable dilation of the vagina walls.

The protruding and disc-shaped sealing lips (4-6) will thus be reclined towards the vaginal opening, and as this reclining deformation occurs in least two posi- tions, the protection device functions as a labyrinth sealing with no notable influence on the surrounding tissue of the vagina walls.

The protection device according to the invention will besides from being an effective infection preventive device also function as a contraceptive device during intercourse, as the protruding lip sealing provides an effective protection, and at the same time the ergonomic shape of the protection device reduces possible discomforts for the man and woman. Furthermore, the plug is optimally suited for positioning against the mouth of the uterus.

The protection device might also be used as a simple practical and easy-to-use tool for swiping cells from the vagina and the vagina walls, reducing the discomfort of such samplings considerably.

As shown and described above, the protection device is extremely user-friendly, as it can be used repeatedly and is easy to clean, just as the configuration is suited for mass production.

Additionally, the consumption of material in connection with production of this protection device (1 ) is rather low thus resulting in low production costs.

In figure 7 a further embodiment of the vaginal protection device (1 ) according to the invention is shown. Compared to the embodiments described above, this embodiment comprises more flexible sealing elements (4) having another con- figuration, but the principle and the function of the protection device are the same. Figure 8 shows in larger details a section of one of the anchoring parts of the sealing elements, which in this example is configures with a nubbly or grooved surface (19). This configuration ensures an improved contact with the vagina and provides an increased protection against displacement. Here the sealing elements (3) also constitute an interconnected entity, in which the central anchoring part (2) is nested and/or embedded. The anchoring part (2) is here made of a different material than the sealing elements, e.g. of plastics or a metal, and will be maintained in the plug-like element comprising the sealing elements by means of a protruding tap (20). The anchoring part may also be maintained behind a narrowing in the plug-like element or in another way being obvious for a person skilled in the art.

In an embodiment of the invention the protection device (1) is configured with a valve function (50) placed in the top of the plug-like element comprising the sealing elements (3), as shown in Fig. 7. Hereby free passage for secretion or the like out of the cervix and the area over the protection device and out via the anchoring part (2) is secured - but obviously not the other way. The valve function may be configured as a shunt or as s small water lock comprising a ball valve or another type of one-way valve.

The anchoring part is shown in larger details in figure 9 along with sections of the applicator or the insertion push rod (8). In figure 10 the anchoring part is shown, as seen from the end in section A-A in figure 9. The anchoring part (2), which here comprises a bush, is at its front end provided with two taps or protrusions (22) positioned (about 180 degrees) displacedly opposite each other, which functions as a backstop for push rod (8). The rear of the plastic bush has a plane cylindrical hole (23) with a conic inlet, which facilitates easy and comfortable insertion of the applicator (8). Here the insertion applicator can be used for both insertion and removal of the protection device. For obtaining a meshing between the insertion applicator and the protection device, the insertion applicator is turned 45-90 degrees.

In the figures 11-14 an inflatable embodiment of a vaginal protection device ac- cording to the invention is shown. Figure 11 shows the inflatable vaginal protection device in an axial section, and figure 12 shows in larger details the applicator meshing with the anchoring part. In the figures 13 and 14 the sections A-A and B-B from figure 12 are shown, respectively.

The protection device (1) here constitutes an inflatable cavity (30), permitting to change the outer diameter of the plug-like element to almost any diameter within an actual diametrical range (111) (as implied in the figure) as well as reduce the obtained diameter back to the small outer original diameter. Here, the insertion applicator (8) has the additional function that it is able to establish a pressure variation in the protection device. Hereby it is possible to give the device a desired adapted pressure against the vagina and an optimal and secure sealing just as the woman will not experience any discomfort due to excessive pressure when using the protection device.

In an embodiment the central anchoring protection device comprises a central anchoring part (2) equipped with a base (24) with openings (25), here shown in figure 12 and 14 with 4 holes (25) displaced 90 degrees from each other. The holes are provided in order to avoid vacuum against the end face (24) of the tube under an axial traction, but may also be omitted, have other configurations

or vary in number or be positioned in the sides of the anchoring part or the like.

The opening (26) of the anchoring part is plane in order to obtain a sealing function between the tubular insertion applicator (8) with an established O-ring (27) and the anchoring part (2). The anchoring part has in its rear end, as shown in figure 9 and 14, two protrusions (22) pointing in the direction of the centre, displaced (about 180 degrees) from each other. The tip of the insertion applicator (8) is shaped as a flat profile (34) enabling the tip to pass the aforementioned protrusions.

The anchoring part (2) of the plug-like element is here shaped as a central tube with a valve function which might provide a backstop for the aforementioned insertion applicator (8). When the insertion applicator (8) and the protection device (1) are inserted into the vagina, the O-ring (27) is active enabling applica- tion of an adapted and appropriate larger or minor excess pressure. This can be done e.g. by squeezing a rubber ball (300), which here is mounted at the protruding end of the insertion applicator as shown in figure 11. The rubber ball can be shaped with various diameters and can practically have any given diameter within a desired range. The size of the rubber ball may be decided either on the basis of a medical evaluation or the user's evaluation, as the before mentioned light squeezing of the rubber ball will be directive for the contact pressure of the protection device on the inner contour of the vagina. Once this has been decided, this procedure will become a repetition or routine for each single user.

The insertion applicator (8) has a centre drilling (31), whose outlet is in front of the position of the mentioned O-ring (27). When inflating the protection device (1) the air passes via the insertion applicator into the protection device via a sectional drilling (28) or alternatively via a number of holes, which might be provided with valves. The insertion applicator is subsequently turned approx. 45-90 degrees enabling the applicator to be removed unrestrictedly from the protection device and the vagina. The protection device has an integrated valve function and will thus maintain the excess pressure.

When the woman wishes to remove the protection device, the insertion applica-

tor (8) is easily inserted into the conic inlet hole (26) of the protection device. Now the insertion applicator is turned to one side or the other, whereby the engagement is established above itself, which enables the anchoring device (2) to be displaced towards the vagina opening whereby the sealing function of the bottom ceases. In this way the excess pressure is released to the applicator, and the minimum diameter of the protection device is immediately reestablished. The protection device can now be removed with no notable resistance from the vagina.

The embodiment of the protection device according to the invention facilitates insertion of the device into the vagina and ensures the exact position for achieving optimal infection protection.

The various configuration of the protection device according to the invention can advantageously be produced by e.g. injection moulding.

It must be understood that the invention as described and depictured in the present description and figures, may be modified or changed and still be comprised by the scope of protection of the below patent claims.