Intravaginal device for treating pelvic pain and for blocking vaginal fluids

Abstract

Intravaginal device for treating pelvic pain and for blocking fluids through a vagina, the intravaginal device comprises: a body configured to be placed in a vagina, the body comprising a ring-shaped rim configured to seal the body against the vaginal wall, when placed in the vagina, the body comprising a closure means closing the surface area within the ring-shaped rim to block fluids through the vagina; and electrostimulation means configured to stimulate the vaginal wall to treat pelvic pain.

Description

[0001] INTRA VAGINAL DEVICE FOR TREATING PELVIC PAIN AND FOR BLOCKING VAGINAL FLUIDS

[0002] Technical Field

[0003] The present invention relates to an intravaginal device for treating pelvic pain and for blocking vaginal fluids

[0004] Prior art

[0005] Menstrual pain and menstrual bleeding are common challenges faced by many women during their reproductive years, impacting their quality of life. Pain, often caused by uterine contractions (dysmenorrhea), can range from mild discomfort to debilitating cramps, interfering with daily activities, work, and mental well-being. Menstrual bleeding, more generally menstrual flow or liquids, can cause physical discomfort, inconvenience, and emotional strain, often disrupting daily activities and overall well-being.

[0006] The problem of menstrual fluids is normally managed by the means of menstrual hygienic products. These menstrual hygienic products can be broadly categorized in absorbing hygienic products like tampons, sanitary / menstrual pads, pantyliners or period underwear and collecting hygienic products like menstrual cups, menstrual discs. Menstrual hygienic products can be further categorized in extra-vaginal products like sanitary / menstrual pads, pantyliners or period underwear and intravaginal products like tampons, menstrual cups and menstrual discs.

[0007] Menstrual pain can be treated in many ways like by general pain medication, hormonal control, heat therapy or other ways. Another way to treat pelvic pain in general is via electrostimulation as disclosed for example in WO2022 / 086893A1. However, such pelvic pain therapy devices are difficult to use during menstruation.

[0008] Therefore, it was proposed to incorporate such electrostimulation therapy in tampons like in W02024 / 011123A1 or WO00 / 07658A1. However, although this idea has been known for many years, no working product has been developed that combines a pelvis treatment device with an absorbing intravaginal menstrual hygienic device.

[0009] Brief summary of the invention

[0010] It is the object of the invention to provide a device which improves the pelvic pain reduction and the vaginal hygiene of women.

[0011] It is further the object of the invention to provide a device which eases the challenges faced by many women during their menstrual cycle.

[0012] According to the invention, this object is solved by an intravaginal device for treating pelvic pain and for blocking fluids through a vagina, the intravaginal device comprises: a body configured to be placed in a vagina, the body comprising a ring-shapedrim configured to seal the body against the vaginal wall, when placed in the vagina, the body comprising a closure means closing the surface area within the ring-shaped rim to block fluids (or its passage) through the vagina or the vaginal canal; and a means configured to stimulate the vaginal wall to treat pelvic pain.

[0013] Integrating the electrostimulation against pelvic pain in an intravaginal device which stops or blocks vaginal fluids has the advantage, that the same device which is used for blocking the fluids in the vagina and is placed there an extended period of time can thus be used continuously to treat the pelvic pain. The body with the rim allows sealing the vaginal channel without the need for an absorbing material which permits the reuse of the intravaginal device many times. Therefore, the electronics for the electrostimulation for the pelvic pain treatment can also be used many times.

[0014] According to the invention, this object is solved by a collecting menstrual hygiene device configured for treating pelvic pain and for collecting vaginal fluids, the device comprises: a body having a shape configured to be placed in a vagina at the vaginal wall and to collect vaginal fluid and prevent the collected vaginal fluid from leaving the vagina; and electrostimulation means configured to stimulate the vaginal wall to treat pelvic pain.

[0015] Integrating electrostimulation against pelvic pain in a menstrual hygiene device has the advantage that the device for collecting the menstrual fluids can treat the menstrual pelvic pain effectively by electrostimulation. Since the menstrual hygiene device is of the collecting type (rather than the absorbing type), the device is reusable. Integrating the pelvic pain treatment in such a collecting menstrual hygiene device allows to reuse the electronics for the electrostimulation for the pelvic pain treatment many times. The dependent claims refer to further advantageous embodiments.

[0016] In one embodiment, the body comprises a ring-shaped rim configured to be placed / pushed against a vaginal wall of the vagina and a blocking means in the space enclosed by the rim (to block the passage through the vagina at the position of the rim in the vaginal channel).

[0017] In one embodiment, the intravaginal device being a collecting menstrual hygiene device (in contrast to an absorbing menstrual hygiene device). Collecting menstrual hygiene devices can be reused (contrary to absorbing menstrual hygiene devices like tampons). This allows the electronics for treating pelvic pain in the collecting menstrual hygiene device to be reused multiple times. In an absorbing menstrual device, the electronics, if inserted in the tampon can normally be used only once and is thus disposable.

[0018] In one embodiment, the closure means forms a receptacle to collect vaginal fluids. In one embodiment, the closure means closing the surface area within the ring-shaped rim to block fluids through the vagina is a receptacle or container configured to close the surface area within the ring-shaped rim, thereby blocking vaginal fluids leaving the vagina and collecting the vaginal fluids.

[0019] In one embodiment, the body is configured to be inserted in a compressed state of the elastic ring-shaped rim, and the elastic ring-shaped rim is configured to exert an outward radial force or pressure against the vaginal wall, when re-expanding towards its original shape. This simple realization allows a good sealing with the wall and a comfortable wearing of the intravaginal device due to the elastic adaptation to the individual form of the vaginal channel.

[0020] In one embodiment, the body with the ring-shaped rim and the closure means is made of an elastomeric material. This material is elastic, comfortable to wear and does not allow vaginal fluid to penetrate the body (contrary to absorbing material like tampons).

[0021] In one embodiment, the intravaginal device or menstrual hygiene device being a menstrual disc. The menstrual disc has compared to a tampon or a menstrual cup the advantage that its position at one end is in the posterior fornix which is the optimal or favorable position to treat the pelvic pain with the electrostimulation. This is why, preferably, at least one, preferably, two of the electrodes are arranged at a first side opposed to the second side with a removal protrusion.

[0022] In one embodiment, the intravaginal device or menstrual hygiene device is a menstrual cup.

[0023] In one embodiment, the closure means forms a receptacle to collect vaginal fluids.

[0024] In one embodiment, the closure means or body has a diameter which is larger than its depth.

[0025] In one embodiment, the closure means or body has a diameter smaller than 80 mm, preferably smaller than 70mm and / or larger than 50mm. These are suitable dimensions to position the intravaginal device in the fornix, preferably with the electrodes in the posterior fornix. If the body, closure means or rim is not circular, the diameter refers preferably to the longest diameter.

[0026] In one embodiment, the body is designed such that a first side of the rim can be positioned at a fornix of the vagina, preferably a posterior fornix of the vagina. In this position, the body seals the vagina for the passage of fluids into the vagina or out of the vagina.

[0027] In one embodiment, the body comprises a removal protrusion for facilitating the removal of the intravaginal device.In one embodiment, the removal protrusion is arranged at a side opposed to the electrodes.

[0028] In one embodiment, the removal protrusion protrudes from the rim. In one embodiment, removal protrusion protrudes radially to a receptacle axis from the rim. In one embodiment, removal protrusion protrudes substantially parallel to a receptacle axis from the rim. In one embodiment, the removal protrusion is attached bendable at the rim so that the angle between removal protrusion and an axis of the receptacle is changeable

[0029] In one embodiment, the removal protrusion protrudes radially to a receptacle axis from a bottom of the receptacle.

[0030] In one embodiment, the removal protrusion protrudes centrally from a bottom of the receptacle.

[0031] In one embodiment, the electrostimulation means comprises at least one, preferably two electrodes arranged in the rim. Since the rim presses against the vaginal wall to obtain a sealing effect and to block the fluids in the vagina, the contact with the vaginal wall is particularly good. By arranging the electrodes in the rim which seals the vagina, not only are two functions combined in the same device, but also the electrostimulation is improved as the force of the rim against the vaginal wall to exert the sealing effect also improves the contact to the vaginal wall for the electrostimulation and thus improves the treatment of the pelvic pain.

[0032] In one embodiment, the body is made of elastic polymer, wherein the at least one electrode is realized in conductive elastic polymer embedded in the elastic polymer of the body. In one embodiment, the body is made of silicon, wherein the at least one electrode is realized in conductive silicone embedded in the silicone of the body.

[0033] In one embodiment, the electrostimulation means comprises a power source, electronics and a conductor means, wherein the conductor means are configured to connect the electronics with the at least one electrode, wherein the electronics are configured to receive the power from the power source and to generate an electrical stimulation signal at the at least one electrode to stimulate the vaginal wall.

[0034] In one embodiment, the conductor means extends along the rim.

[0035] In one embodiment, the conductor means extends from the bottom of the receptacle to the rim at the position of the at least one electrode.

[0036] In one embodiment, the conductor means is realized for each electrode as a conductor track on a flexible printed circuit board.

[0037] In one embodiment, the conductor means and the electronics are realized on the same flexible printed circuit board.In one embodiment, the conductor means and the electronics are realized on a rigid-flex printed circuit board with at least some parts of the electronics being on the rigid part of the printed circuit board and at least the conductor means being realized in the flexible parts of the printed circuit board.

[0038] In one embodiment, the power source is arranged in the bottom of the receptacle.

[0039] In one embodiment, the power source is arranged in the rim or the lateral wall of the receptacle.

[0040] In one embodiment, the power source is a battery and the electrostimulation means comprises a charging circuit for wireless charging of the battery.

[0041] In one embodiment, the electronics (or a part of the electronics) are arranged in the removal protrusion.

[0042] In one embodiment, the conductors extend from the removal protrusion into the rim and / or receptacle, preferably into the rim. This does not only allow electrical connection between the electrode(s) in the rim to at least one component of the electronics in the removal protrusion but also increases the structural stability of the connection between the removal protrusion and the rim and / or receptacle.

[0043] In one embodiment, the electronics (or a part of the electronics) are arranged in the rim opposite to the at least one electrode.

[0044] In one embodiment, removal protrusion is arranged opposed to the at least one electrode. In one embodiment, the collecting menstrual hygiene device is nonabsorbent and / or is vaginal fluid impermeable. This allows that the device is reusable.

[0045] In one embodiment, the collecting menstrual hygiene device comprising a sensor for measuring a sensor parameter, wherein the electrostimulation means is configured to control the electrostimulation signal based on the measured sensor parameter. This allows to adapt the electrostimulation to the current pain situation based on the measured sensor parameters.

[0046] In one embodiment, the collecting menstrual hygiene device comprising a sensor for measuring a physiological or biomechanical sensor parameter of a pelvic region and a wireless communication interface configured to send the measured sensor parameter to an external device, e.g. a smartphone. This allows to analyse the pelvic pain based on measured sensor values. Al analysis could use these parameters to report about the vaginal health and / or establish a pelvic pain profile. If the user inputs (e.g. in the external device) user feedback on the current level of pelvic pain, it can be identified which sensor parameters (and their values) are related to the pelvic pain. This could also be used above to automatically adapt the electrostimulation.In one embodiment, the sensor comprises one or more of : a) a pH sensor configured to measure an acidity level of a vaginal environment, b) an inertial measurement unit configured to detect user activity, posture, or pelvic movement, c) a temperature sensor configured to detect local temperature variations indicative of inflammation, ovulation, or infection, d) a contraction sensor configured to monitor pelvic floor muscle activity, the contraction sensor comprising a pressure sensor and or an electromyography sensor, and e) a bio impedance sensor configured to analyze tissue characteristics or properties of vaginal fluids.

[0047] In one embodiment, the at least one electrode on the rim extends along the rim for a circular length of more than 30°. Preferably the at least one electrode comprises two electrodes on the rim extending each along the rim for a circular length of more than 30°. These long electrodes provide a good electrical contact with the vaginal tissue. These long electrodes are particularly advantageous when they are realized as soft electrodes.

[0048] Other embodiments according to the present invention are mentioned in the appended claims and the subsequent description of an embodiment of the invention.

[0049] Brief description of the Drawings

[0050] Fig. 1 shows a first embodiment of the intravaginal device according to the invention.

[0051] Fig. 2 shows a second embodiment of the intravaginal device according to the invention.

[0052] Fig. 3 shows a variation of the first embodiment of the intravaginal device according to the invention.

[0053] Fig. 4 shows a variation of the second embodiment of the intravaginal device according to the invention.

[0054] Fig. 5 shows a third embodiment of the intravaginal device according to the invention.

[0055] Fig. 6 shows a fourth embodiment of the intravaginal device according to the invention.

[0056] Fig. 7 shows schematically the position of the intravaginal device of Fig. 10 in a vagina.

[0057] Fig. 8 shows schematically the position of the intravaginal device of Fig. 3 in a vagina.

[0058] Fig. 9 shows a fifth embodiment of the intravaginal device according to the invention.

[0059] Fig. 10 shows a sixth embodiment of the intravaginal device according to the invention.Fig. 11 shows a seventh embodiment of the intravaginal device according to the invention.

[0060] In the drawings, the same reference numbers have been allocated to the same or analogue element.

[0061] Detailed description of an embodiment of the invention

[0062] Other characteristics and advantages of the present invention will be derived from the non-limiting following description, and with reference to the drawings and the examples.

[0063] Fluids in the vagina could be vaginal fluids or extra-vaginal fluids. Vaginal fluids are all fluids produced by the vagina. During the menstrual cycle, the vaginal fluids contain menstrual fluids. However, vaginal fluids can also contain other vaginal fluids like cervical mucus, normal vaginal discharge or other. Extra-vaginal fluids could be any fluid entered from outside the vagina, for example sperm during sexual intercourse.

[0064] The intravaginal device according to the invention is configured to fulfil two purposes, first to treat pelvic pain by electrostimulation and second, to be positioned / to seal such in the vagina that fluids cannot any more enter or leave the vagina. Preferably, the second function is to be positioned such in the vagina that vaginal fluids cannot leave the vagina, especially for preventing menstrual fluids from leaving the vagina. Preferably, the intravaginal device is an intravaginal hygiene device, preferably an intravaginal hygiene device of the collecting type, also called an intravaginal collecting hygiene device. The intravaginal hygiene device is preferably a menstrual hygiene device but could be equally used for collecting other vaginal fluids.

[0065] Embodiments of the intravaginal collecting hygiene device 1, 1 ' are shown in Fig. 1 to 11. Before describing each embodiment in more detail, the intravaginal collecting hygiene device is described in general.

[0066] The intravaginal device 1, 1 ' comprises a body and an electrostimulation means.

[0067] The body is configured to be placed in a vagina. The body is configured to seal the body against the vaginal wall 28, when placed in the vagina in a sealing position, and to block the passage of fluids through the vagina at the sealing position. The body is preferably elastic so that it can be inserted in the vagina and can adapt to the form of the vagina in the sealing position. The body is preferably made of an elastic material, preferably of an elastomeric material, for example silicone. Elastic material has the property that it (substantially) returns to its original and / or relaxed shape after deformation. In other words, the elastic material has a certain stiffness which generates a force under deformationforcing the elastic material back into its original and / or relaxed shape. So, the elastic material is resilient. Due to the elasticity of the body, the body is pressed against the vaginal wall for sealing. This allows the body to seal against the vaginal wall so that the vaginal channel can be effectively sealed. The pressure against the vaginal wall is obtained by the resilience of the body tending to return to its original shape. Since the body is inserted in a compressed shape into the vagina, the body generates a radial pressure against the vaginal wall due to its tendency to recover its natural / relaxed / original shape. Obviously other elastic materials are possible as well. If the body is elastic, all description refers to the non-compressed form of the elastic body, i.e. to its form / shape without any external influence. In a less preferred embodiment, the body could be made of a non-elastic material. Then, the body requires a mechanism which allows the shape of the body to be switched between a reduced shape for inserting the body and an expanded shape for sealing the vaginal channel. The body

[0068] The body extends preferably in a horizontal plane and a vertical direction. The vertical direction can be distinguished in or defined by a top direction and a bottom direction opposite to the top direction. The body comprises preferably a top side and a bottom side 12. The horizontal plane is perpendicular to the vertical direction. The horizontal plane is spanned by a first direction and a second direction. The first direction extends from a first side 6 to a second side 7 of the body or of the rim 4. The second direction extends perpendicular to the first direction and / or extends from a third side to a fourth side of the body or the rim 4. It is understood that the terms horizontal and vertical are used for reference purposes only and do not limit the final position of the body in the vagina. The body is preferably symmetrical with respect to a symmetry plane parallel to a plane spanned by the vertical direction and the first direction. The symmetry plane in the sealing position in the vagina corresponds substantially to the sagittal plane of the woman wearing the intravaginal device.

[0069] The body comprises preferably a rim 4 and a closure means 2.

[0070] The rim 4 is ring-shaped. The ring-shaped rim 4 extends preferably substantially in the horizontal plane. Preferably, the ring-shaped rim 4 extends fully in the horizontal plane, i.e. in a side view from the first, second, third or fourth side, the rim 4 would extend along a straight line. However, it would also be possible that the ring-shaped rim 4 is not fully extending in the horizontal plane, for example when the side view from the third or fourth side shows the rim 4 from the first side 6 to the second side 7 (at least in parts) as a curved or bent line, especially with the second side 7 of the rim 4 bending or curving more towards the top direction out of the horizontal plane. This provides the advantage to positioning thesecond side 7 higher, thus closer to the posterior fornix. In this cose, the horizontal plane would be considered the horizontal plane of the principal extension of the rim 4.

[0071] The ring-shape of the rim 4 shall include any shape of the rim 4 in which the trajectory of the rim 4 meets again with a previous point of the trajectory of the rim 4 to form a ring and / or to enclose a surface. Preferably, one end of the rim 4 is connected with the opposed end of the rim 4 so that the rim 4 is basically endless as the rim 4 does not end at one end but starts right over again. The two ends could be integrally formed or could be connected. In case, the two ends are integrally formed, i.e. the ring-shaped ring is manufactured already as a ring, the above-mentioned ends shall be considered as virtual ends which could be any point along the trajectory of the ring-shaped rim 4. Thus, this point would form the two virtual ends of the rim 4 meeting together. Preferably, the two ends of the rim 4 meet such that the cross-section of the rim 4 at the first end touches the crosssection of the rim 4 at the second end, preferably such that the cross-sections are aligned and / or that the cross-section of the first end does not protrude the cross-section of the second end. However, it would also be possible that the first end has a first end portion and the second end has a second end portion, wherein the first end and the second end touch each other to close the ring. For example, the first end portion and the second end portion could be arranged parallel to each other touching each other in this parallel arrangement.

[0072] The ring-shape of the rim 4 encloses a surface which preferably corresponds to a typical shape of the vaginal wall in the sealing position of the device. The ring-shape of the rim 4 is preferably round (or rounded) with a longitudinal axis parallel to the first direction being longer than a lateral axis parallel to the second direction (see first to sixth embodiment). Preferably, the ring-shape of the rim 4 is an oval ring-shape, i.e. the ring of the rim 4 encloses an ovally formed surface. The oval ring-shape rim 4 can have an egg ringshape, an elliptic ring-shape, a Cassini oval ring-shape, a stadium ring-shape or many more oval shapes. However, it is also possible that the ring-shape of the rim 4 is circular as in the seventh embodiment. The ring-shape of the rim 4 refers to the shape of the ring-shaped rim 4 from a top view or a view on the ring from a view direction which is perpendicular to the horizontal plane. The centre point of the rim 4 is the centre point of the ring formed by the rim, e.g. the intersection point of the longitudinal and lateral axis. It is clear from the previous definition of the term "ring-shape" that this is not limited to circular rings and also encompasses other ring-shapes, e.g. oval ring shapes, shall be covered by this term.

[0073] The rim 4 is made of elastic material. The description of the elastic material for the body holds equally for the elastic material of the rim 4.The rim 4 is configured to be in contact with the vaginal wall 28, when the body is in the sealing position. The rim 4 is configured to press against the vaginal wall 28 to obtain the sealing effect. The pressure enables the body to seal against the vaginal wall. Due to the ring-shape of the rim 4 pressing radially outwards against the vaginal wall, the rim 4 forms a 360° sealing line with the vaginal channel so that no fluids can pass beyond the rim 4 (between the rim 4 and the vaginal wall). The pressure against the vaginal wall for sealing is obtained preferably by the elastic properties of the rim 4 (or the body). This pressure (due to the elastic properties) against the vaginal wall is generated by the resilience of the rim 4 tending to return to its natural / relaxed shape. Since the rim 4 is inserted into the vagina in a compressed shape, the rim 4 generates / exerts a (outward) radial pressure against the vaginal wall due to its tendency to expand towards its natural / relaxed / original shape or its desire to decompress. This allows first an effective sealing with the vaginal wall and second, allows the rim 4 to adapt to the cross-sectional shape of the vaginal channel. The rim 4 is preferably thicker than the closure means 2 so that the rim 4 is more rigid than the closure means 2 and exerts a strong(er) force against the vaginal wall 28 (than the closure means 2). The rim 4 could comprise one or more sea ling lips extending as a closed ring at the outside or outer surface of the rim 4 to improve the sealing effect (not shown in the figures).

[0074] To insert the body into the vagina, the body or the rim 4 is compressed. This compression is preferably obtained by two fingers inserting the body / rim 4 but could alternatively also be obtained by an applicator. Such an applicator can contain the body in the compressed state to insert the compressed body with the applicator in the vagina and release the body / rim 4 within the vagina by removing it from the applicator.

[0075] Preferably, two opposite sides of the rim 4 are pressed together to insert the body in the vagina so that they extend substantially parallel to each other. Preferably the third side and the fourth side of the rim 4 are pushed or compressed together, when inserting the body in the vagina through the opening 23. This allows the user to control the correct position or orientation of the electrodes at the front of the rim 4 when inserting the body in the vagina. When the compressed body is then inserted with the second side leading towards the cervix 27, the second side 7 of the rim 4 will be automatically positioned at the posterior fornix, once the first side 6 is pushed or tucked behind the pubic bone. By releasing the pressure on the third and fourth side of the rim 4, the rim 4 presses against the vaginal walls 28 and stabilizes in the sealing position. The pubic bone prevents the rim 4 from moving towards the opening 23, thereby maintaining the body stably in the sealed position.

[0076] In some embodiments, the compressed rim 4 is, in addition to the compression of the two opposite sides of the rim 4, is further folded (so that basically four sides of the rim4 are arranged substantially parallel) in order to insert the body in the vagina. This could be used for example for an embodiment like the below described menstrual cup with electric stimulation or could be used for inserting the body within an applicator. This could for example be used for the insertion via an applicator.

[0077] The rim 4 has preferably at least one bending point 18 at which the bending of the ring-shaped rim 4 is easier than at other parts of the rim 4. The bending point 18 is thus configured to facilitate bending of the ring-shaped rim 4 relative to other parts of the rim 4. The bending point 18 is preferably arranged or located at the first side 6 and / or at the second side 7 of the rim 4. In the first and second embodiment of the intravaginal device 1 , the bending point 18 is realized or formed by a notch or a corner which facilitates the bending. In the third embodiment in Fig. 5, in addition to the notch or corner, the rim 4 is cut (through at the corner) so that the rim 4 (ends) opens when the third and fourth sides are compressed towards each other. Since the rim 4 in the sealing position pushes against the vaginal wall 28, this force against the wall 28 is also exerted at the bending point 18 where the two ends of the rim 4 push one versus the other and assure that the sealing is tight enough. In other words, the force against the wall 28 at the bending point(s) causes the two ends of the rim 4 to press against each other ensuring an effective seal.

[0078] The closure means 2 is configured to close the surface area within the ringshaped rim 4 to block (the passage of) fluids through the vagina. Thus, the closure means 2 is connected with its peripheral sides with the rim 4 in order to close the opening formed by the rim 4. The closure means 2 is made preferably of a vaginal fluid impermeable material, i.e. a liquid impermeable material to vaginal fluids. Thus, the closure means 2 forms a (fluid impermeable) barrier (e.g. a silicone barrier) which prevents any fluids from penetrating into it or through it. The closure means 2 or barrier is preferably realized as a film or membrane which is connected peripherally to the rim 4 so that no fluids can go through the body, film and / or in between the rim 4. The closure means 2 and / or film is made of a material which blocks fluids from one side to the other, i.e. which is impermeable to fluids, e.g. an elastic polymer like silicone. Preferably, the rim 4 and the closure means 2 are made of the same material, preferably silicone. However, it would also be possible to make the closure means 2 out of a different material.

[0079] In the intravaginal collecting hygiene devices according to the shown embodiments, the closure means 2 is a receptacle or container for collecting vaginal fluids. The receptacle extends from the rim 4 or the horizontal plane downwards (in the bottom direction). The receptacle has an opening 5 on its top side. In the sealing position, the vaginal fluids flow into the opening 5 of the receptacle 2 and are collected in thereceptacle 2. Since the rim 4 seals the body versus the vaginal wall 28 (seals against the vaginal wall 28), the vaginal fluids can only flow into the receptacle 2. The receptacle 2 contains preferably lateral walls which extend at least partly in the bottom direction until the bottom side 12 of the receptacle 2 or of the body. Obviously, the closure means 2 may also first extend in the horizontal plane towards the centre of the ring-shaped rim 4 and then downwards into the receptacle 2. The receptacle axis is the line between the deepest point of the receptacle and the centre point of the rim 4. If the receptacle comprises a region (not a point) which is deepest, the centre point of the deepest region is considered as the deepest point for the definition of the receptacle axis. The receptacle axis may extend along the vertical axis. The receptacle axis may also have an angle with the horizontal plane larger than 45°, preferably larger than 60°, preferably larger than 75°, preferably larger than 80°. The receptacle axis may have an angle with the first direction (angle enclosed between first side of rim 4, centre point of rim 4 and deepest point of bottom side 12) may be made smaller than 90° in order to adapt the receptacle 2 to the anatomy of the cervix 27, when the body is positioned in the vagina. While these asymmetries between the first and second side 6, 7 of the body are advantageous for the first to sixth embodiment which like a menstrual disc are positioned between the pubic bone and the posterior fornix 25, the seventh embodiment which is positioned like a menstrual cup rather in the vaginal canal is rather symmetric and the receptacle axis extends preferably in the vertical direction or is perpendicular to the rim 4 or its horizontal plane. The receptacle 2 preferably has a capacity to collect a volume of more the 10 millilitre (ml), preferably more than 20 ml, preferably more than 30 ml, preferably more than 35 ml. The receptacle 2 preferably has a capacity to collect a volume of less than 100 ml, preferably less than 90 ml, preferably less than 80 ml, preferably less than 70 ml.

[0080] In one embodiment, the closure means 2 is made of an elastic material. The closure means 2 can be formed as an elastic film / membrane which tends to return to its original shape, i.e., the shape of the receptacle or body. Alternatively, the closure means 2 or film or membrane may be configured to be a stretchable and / or non-resilient film / membrane (without the tendency to return to a specific shape), similar to the material of a condom or like a thin extensible membrane. This increases wearing comfort, as the receptacle conforms to the constraints of the vaginal anatomy. This property may be achieved, for example, by reducing the thickness of the film / closure means 2. However, it may have a higher risk that the vaginal fluids are pressed out of the receptacle and that the film gets damaged.Fig. 7 and 8 show the anatomy of the female vagina. The vagina comprises an opening 23 at one end and the cervix 27 as the other end of the vagina serving as the entrance to the uterus 21. The vaginal canal 22 connects the opening 23 and the cervix 27. The side of the vagina arranged or oriented towards the rectum is the posterior side of the vagina and the side of the vagina arranged or oriented towards the bladder is the anterior side of the vagina. Vaginal walls 28 surround the vaginal canal 22 from the entrance 23 up to the cervix 27. The region of the posterior vaginal wall 28 close to the cervix 27 defines the posterior fornix 25. The region of the anterior vaginal wall 28 adjacent to the cervix 27 defines the anterior fornix 26. The pubic bone is situated in the anterior vaginal wall 28 of the vagina. Neural structures of the pelvic region (like pelvic nerves) pass in close proximity to the vaginal posterior fornix 25. Accordingly, electrostimulation applied near the posterior fornix 25 enables effective stimulation of said neural structures for the treatment of pelvic pain.

[0081] As previously mentioned, the first to sixth embodiments of the intravaginal device 1 are configured to be positioned at the upper end of the vaginal canal close to (or proximate to) the cervix 27. Preferably, the intravaginal device 1 is positioned with its second side 7 at the posterior fornix 25 (similartoa menstrual disc), preferably engaging the posterior fornix 25. The first side 6 of the intravaginal device 1 is preferably positioned at or superior to the pubic bone. This configuration allows the intravaginal device 1 to be secured / fixed between the anterior vaginal wall, preferably (behind) the pubic bone and the posterior fornix 25 as shown in Fig.8.

[0082] In an alternative embodiment of the intravaginal device 1 ', it is positioned rather in the lower vaginal canal 22 as shown in Fig. 7 (similar to a menstrual cup).

[0083] In a preferred embodiment, the intravaginal device 1, 1 ' comprises a removal protrusion 3. The removal protrusion is configured to facilitate the removal of the intravaginal device 1, 1 ' from the vagina. The removal protrusion 3 extends / protrudes preferably from the second side 7 and / or from the rim 4 of the body (see first to fourth embodiment and sixth embodiment. The removal protrusion 3 may extend (in its non-compressed state) in the horizontal plane and / or radially with respect to the centre point of the rim 4 as for example in the first embodiment in Fig. 1 or 3. The removal protrusion 3 could extend more downwards from the horizontal plane like the second, third, fourth and fifth embodiment. The removal protrusion 3 is preferably bendable at the connection point / line with the rim 4. This facilitates the insertion of the body. In some embodiments, the removal protrusion 3 is not bendable versus the top direction or is configured to resist bending towards the top direction. This can be achieved by side-flaps 15 which connect the removal protrusion 3 laterally to the receptacle 2 as shown for example in Fig. 5. The side flaps are connected on the other sideto the lateral wall of the receptacle 2 and holding the removal protrusion 3 down. This creates a kind of pocket 16 (between the removal protrusion 3, the lateral wall of the receptacle 2 and the flaps 15) for inserting a finger to grasp the removal protrusion 3. In fig.

[0084] 6, a kind of pocket 16 is formed between the removal protrusion 3, the lateral wall of the receptacle 2 and the flaps 15 for inserting a finger to grasp the removal protrusion 3. The pocket 16 can be formed by increasing (or thickening or enlarging) the rim 4 on the second side 7 forming the removal protrusion 3 integrally with this increased rim 4 (similar to a collar of a pullover). This limits the movement of the removal protrusion in the top direction (or at least makes the movement towards the top direction (further away from the receptacle 2) harder (or more difficult) than versus the bottom direction (closer to the receptacle 2)). In some embodiments, e.g. in Fig. 10 and 11, the removal protrusion extends from the bottom side 12 of the receptacle 2. In some embodiments, e.g. in Fig. 11, the removal protrusion 3 extends along the receptacle axis or vertical axis from the bottom side 12 of the receptacle. In some embodiments, e.g. in Fig. 10, the removal protrusion 3 extends along the first direction from the bottom side 12 of the receptacle (maybe with a component towards the vertical direction).

[0085] The electrostimulation means are configured to stimulate the vaginal wall 28 (preferably the posterior fornix 25) to treat pelvic pain. The electrostimulation means (electronics) comprise electrodes 8, signal generation means, conductors 9 to connect the electrodes 8 with the signal generation means and a power source 11 .

[0086] The electrodes 8, 8' refer to any electrically conductive stimulation interface configured to electrically couple the device to vaginal tissue and deliver an electrical stimulation thereto. The electrode 8, 8' can be realized as any conductive element configured to conduct the electrostimulation signal from the signal generation means and configured to stimulate the vaginal tissue / wall with the electrostimulation signal. The conductive element could be for example a metallic element, a conductive surface, conductive coating, conductive polymer, or equivalent electrically conductive elements. The at least one electrode 8, 8' can be a galvanic electrode or a capacitive electrode. The galvanic electrode 8, 8' is arranged such that it is in electrical contact with the vaginal tissue / wall to stimulate the vaginal tissue with the electrostimulation signal conducted from the electrode 8, 8' to the vaginal tissue. In this case, the electrode 8, 8' can be exposed and be in direct contact with the vaginal wall or could be covered or encapsulated by an ion-permeable layer so that the electrostimulation signal is conducted through the ion-permeable layer. The latter could have the advantage that it allows direct current flow to the tissue, but provides (hermetic) encapsulation of the electrode 8', 8. Thus, the galvanicelectrode 8, 8' would assure an ion-exchange between electrode and tissue. The electrode 8, 8' could also be a capacitive electrode which is encapsulated in the elastic material of the rim 4 and vaginal tissue is stimulated by capacitive coupling with the capacitive electrodes 8, 8'. This is the case, if the electrode 8, 8' is not exposed and the encapsulating layer or layers do not allow an ion-exchange with the vaginal tissue.

[0087] The electrode 8, 8' is preferably realized as a soft (and conformable) electrode, i.e. an electrode made of a soft material. A soft electrode or material has such a low stiffness and / or low Young's modulus that it bends, stretches and / or deforms with the body or rim 4. Such soft electrodes 8, 8' can be achieved by thin metal layers or foils (for example embedded in or coated on the elastic material of the rim 4), conductive polymers, elastomer-embedded conductors, or other means. The electrodes 8, 8' can be mounted on a substrate (of the rim 4) or coating made of a soft and biocompatible polymer, such as thermoplastic polyurethane or silicone, and are connected via conductive leads made of any biocompatible conductive material suitable for repeated vaginal use, such as a noble metal, a metal alloy, or a conductive coating.

[0088] The electrodes 8, 8' are positioned to follow the geometry of the rim of the disc, ensuring stable contact and optimal current distribution with the targeted tissue.

[0089] The electrodes 8, 8' and / or leads / conductors 9 are preferably hermetically encapsulated, preferably by a multilayer polymer stack. This (robust) encapsulation ensures the electrical integrity and reliability of the stimulation system in the humid and dynamic environment of the vaginal cavity, protecting the conductors from delamination and corrosion during repeated use. It further protects against bacteria entering any surfaces between electrodes 8, 8' and the elastic material of the rim 4.

[0090] There are preferably two electrodes 8, 8'. The two electrodes 8, 8' are preferably arranged symmetrically with respect to a line from the first side 6 to the second side 7 and / or with respect to a vertical plane extending from the first side 6 to the second side 7. However, in a different embodiment, it would also be possible to have one electrode or more than two electrodes. The electrodes 8, 8' are preferably arranged in the rim 4, preferably symmetrically. The electrodes 8 are preferably arranged on the second side 7 of the body, preferably at the second side 7 of the rim 4. In one embodiment, the first and / or second electrode extend over a circumferential segment of the rim 4. Preferably, the first and / or second electrode follows the rim 4 circumferentially for a circular length of more than 20°, preferably more than 30°, preferably more than 40°, preferably more than 50°, preferably more than 60°, preferably more than 70°, preferably more than 80°, preferably more than 90°. If the second side 7 (at the symmetry axis) is defined as 0°, the first electrodestarts on the circumference of the rim 4 at a starting angle which is preferably larger than 5°, preferably than 10°, preferably than 15° and / or which is preferably smaller than 45°, preferably than 30°, preferably than 20°, preferably than 15°. From the starting angle the electrode would then extend circumferentially for the circular length in the direction of the first side 6. The second electrode starts on the circumference of the rim 4 at a starting angle which is preferably smaller than -5°, preferably smaller than -10°, preferably than -15° and / or which is preferably larger than -45°, preferably than -30°, preferably than -20°, preferably than -15°. From the starting angle the second electrode would then extend circumferentially for the circular length in the direction of the first side 6.

[0091] When the body is in the sealing position, i.e. in the position in which the body should be placed in the vagina, with its second side 7 at the posterior fornix25, the electrodes 8, 8' at the second side 7 of the rim 4 establish a good / intimate contact (or effective electrical contact) with the vaginal wall 28 at the posterior fornix 25. This contact is obtained and / or maintained due to the sealing pressure generated by the rim 4. In one embodiment, the electrodes 8 could be realized as conductive elastic or elastomeric material embedded in (non-conductive) elastic or elastomeric material of the remainder or rest of the rim 4 (see embodiments of Fig. 1, 3, 5, 9). In one embodiment, the electrodes 8 could be realized as conductive silicone embedded in (non-conductive) silicone of the remainder or rest of the rim 4 (see embodiments of Fig. 1, 3, 5, 9). The conductive silicone is connected with the conductor 9 to receive the electrostimulation signal from the electronics. In another embodiment, the electrodes 8' are realized as metal elements disposed on the surface of the rim 4 connected with the conductors 9. These metal elements could be metallic balls arranged at the end of each conductor 9 embedded such in the elastic material of the rim 4 that a part of the metal element is exposed for getting in contact with the vaginal wall in the sealing position of the rim 4 or body. In one embodiment, the electrodes comprise an exposed conductive metallic material, such as, but not limited to, medical-grade stainless steel.

[0092] In one embodiment, the electrodes comprise a noble metal or conductive alloy, such as, but not limited to, gold, platinum, platinum-iridium alloys, or other biocompatible conductive alloys, the electrodes being integrated, encapsulated, or partially encapsulated within a biocompatible polymer material, such as silicone, TPE, orTPU.

[0093] In one embodiment, electrical contact with the tissue is provided directly by a metallic electrode surface.

[0094] In one embodiment, the electrodes are exposed, partially exposed, or embedded within the polymer material so as to provide an electrical interface with biological tissue.In one embodiment, the electrodes further comprise o surface treatment, such as, but not limited to, polishing, sandblasting, micro- or nano structuring, conductive or electrochemically active coatings, or any other surface modification configured to improve electrical conductivity, electrochemical stability, biocompatibility, or the electrode-tissue interface.

[0095] In one embodiment, electrical contact with the tissue is provided indirectly via a conductive polymer material, such as a conductive silicone.

[0096] The signal generation means is configured to generate the electrostimulation signal which is applied to the electrodes 8 to treat the pelvic pain via electrostimulation. The signal generation means comprises preferably a (digital) chip configured to generate the electrostimulation signal. The chip is preferably a microchip or a microcontroller. However, the chip could also be a general-purpose chip with dedicated software for generating the electrostimulation signal. Preferably, the signal generation means comprises preferably an analogue circuitry to transfer the digital electrostimulation signal in an electric signal. This analogue circuitry could comprise an amplifier. However, it would also be possible to generate the signal using purely analogue components, thereby removing the need for a digital chip. The signal generation means is preferably realized on a circuit board preferably a printed circuit board (PCB) 10. The PCB 10 could be implemented as a flex PCB, a rigid PCT or a rigid-flex PCB, or any other form of electronic substrate or circuit carrier capable of providing the same electronic functionality. The flex PCB 10 offers the advantage that the PCB is not rigid and increases the wearing comfort. Furthermore, the flex PCB 10 can be further used to realize the conductors 9 as conductor tracks extending from the signal generation means to the electrodes 8. For example, in the realizations in Fig. 1, 3, 5 and 10. The conductor tracks 9 on the flex PCB acting as conductors 9 can be arranged within the rim 4 to connect the electrodes 8 at the second side 7 of the rim 4 to the signal generation means at the first side 6, e.g. in the removal protrusion 3. Alternatively, the conductor tracks of the flex PCB could also be arranged in the lateral wall of the receptacle 2 to connect the electrodes 8 at the second side 7 of the rim 4 with the signal generation means or power source 11 in the bottom 12 of the receptacle 2. As noted, the PCB 10 could however also be realized as a rigid PCB or as a rigid-flex PCB, the latter comprising rigid portions and flexible portions. A rigid-flex PCB could be used with the rigid PCB portion supporting components like the chip or signa I generation means and / or the power source 11 , while the flex PCB portion could be used for (at least a part of) the conductors 9. The electrodes 8, 8' could be connected to the distal end of the flex PCB portion (opposed to the rigid PCB part)or could also be realised in the conductor tracks of the flex PCB portion.The signal generation means and / or the PCB 10 is preferably arranged in the removal protrusion 3 and / or at the first side of the device 1. However, it is also possible to arrange the signal generation means or the PCB 10 in the lateral wall of the receptacle as in Fig. 9 or in the bottom 12 of the receptacle 2 as in Fig. 10 or in the rim 4 (not shown).

[0097] The design of the stimulation signal to treat pelvic pain is known in the state of the art and is described subsequently only shortly without any limitation of the invention. Electrostimulation signals used in intravaginal devices for treating pelvic pain are carefully designed to deliver therapeutic effects while ensuring comfort and safety. These signals typically feature a biphasic waveform, which prevents tissue irritation by balancing the electrical charge, and are often delivered in a pulsed pattern to mimic natural nerve activity. The frequency range can be selected or adjusted based on the therapeutic goal. The amplitude, measured in milliamps, is customizable and generally kept low, ensuring gentle stimulation suitable for the sensitive posterior fornix. Pulse widths, typically between 50 to 400 microseconds, are chosen to either target sensory nerves or penetrate deeper tissues for muscle relaxation. To enhance user safety, these devices include features like automatic shut-off after a session, gradual ramp-up of intensity, and safeguards against electrical overload. Overall, these signals aim to modulate pain, relax pelvic muscles, and improve local circulation, providing targeted and effective relief for pelvic pain.

[0098] The electrostimulation signal of the device 1 is specifically designed for pelvic pain relief. The waveform may be biphasic, symmetric or asymmetric. Asymmetric pulses may have a phase ratio between 1:2 and 1:10 to favor gentle sensory stimulation and minimize tissue irritation. The electrostimulation signal has preferably a nominal or maximum current smaller than 100 mA, preferably smaller than 75 mA, preferably smaller than 50 mA, preferably smaller than 40 mA, preferably smaller than 30 mA, preferably smaller than 20 mA, preferably smaller than 15 mA (considering a 500 Ohm load). Symmetric pulses may also be used if compliance or implementation constraints require. Pulse durations per phase are generally in the range of 50 to 450 microseconds. Frequencies are selected between 1 Hz and 150 Hz to target sensory nerves and deeper tissues for muscle relaxation rather than inducing strong muscle contractions. The current amplitude output is 0.1 to 80 mA, typically kept low to provide gentle stimulation of sensitive vaginal tissue, particularly the posterior vaginal fornix. Safety features include gradual ramp-up of intensity, automatic shut-off after a session, and protection against electrical overload. These parameters and the waveform are chosen to modulate pain, improve local circulation, and relax pelvic muscles, rather than to achieve significant pelvic floor muscle contraction or training.In one embodiment, the device is configured to adjust or change the stimulation signal based on a user input. The user input may be received based on a haptic (or tactile) user input interface on the device 1 itself, for example a switch. In a preferred embodiment, the user input for selecting or receiving the stimulation signal is received wirelessly via a communication interface (see description later). The device 1 could offer multiple stimulation modes, such as continuous or burst delivery, to accommodate different user needs and treatment protocols. The selection may be effected by a switch in the device 1 or received via the wireless communication interface.

[0099] The power source is preferably a battery 11. The battery 11 is preferably arranged in the removal protrusion 3. However, it is also possible to arrange the battery 11 somewhere else in the body / device 1, e.g. in the bottom portion 12 as in fig. 9 and 10. The battery 11 or other power source can be mounted directly on the PCB 10 (see Fig. 5, 6) or could be connected via wires (see e.g. Fig. 2, 4) or via conductor tracks of a flex PCB (see e.g. Fig. 1, 10). The electronics preferably comprise a charging circuit for the wirelessly charging the battery 11. This enables the electronics to be encapsulated, thereby facilitating effective cleaning (or sanitization) of the device 1 , while simultaneously ensuring a reliable charging of the battery 11.

[0100] The electronics preferably comprise a wireless communication interface, e.g. a Bluetooth interface (or a similar short-range communication module). The wireless communication interface could be integrated on the PCB 10, e.g. as a communication chip mounted on the PCB 10 together with an antenna 14. The antenna 14 can be formed directly on the PCB 10 as an extra component 14 like in Fig. 1, 6, 9. The wireless communication interface could be used to control the electrostimulation means, e.g. via a connected smartphone or other (external) computing device. The electrostimulation means could be controlled via a user input from an app on a smartphone. The user input can be used to switch the electrostimulation on and off. It could be further used to change the type or parameter of electrostimulation signal. For example, It may further be used to adjust the type or parameters of the electrostimulation signal. The wireless communication interface could further give out certain information about the device 1 , for example the state or status of the battery 11. The wireless communication interface could further give out or transmit sensor information received from sensors of the device 1.

[0101] The device 1 might contain one or more sensors.

[0102] to the device 1 or the electronics may include a filling state sensor. The filling state sensor senses or measures the filling state of the receptacle. The sensed filling statemight be given out via the wireless communication interface, for example, when the collecting hygienic device 1 or its receptacle 2 is full and / or requires emptying.

[0103] The device 1, electronics and / or the one or more sensors may comprise a contraction sensor to monitor pelvic floor muscle activity. The contraction sensor may utilize pressure sensing or electromyography (EMG).

[0104] The device 1, electronics and / or the one or more sensors may comprise a temperature sensor. The temperature measured via the temperature sensor can be used to detect local temperature changes indicative of inflammation, ovulation, or infection.

[0105] The device 1, electronics and / or the one or more sensors may comprise an inertial measurement unit (IMU), such as an accelerometer and / or gyroscope, configured to track user activity levels, posture, or pelvic floor movement which may correlate with pain episodes.

[0106] The device 1, electronics and / or the one or more sensors may include a pH sensor configured to monitor the acidity of the vaginal environment.

[0107] The device 1 , electronics and / or the one or more sensors may comprise a bioimpedance sensor configured to analyze tissue characteristics or fluid properties.

[0108] The electronics may be configured to aggregate the data from the one or more sensors and transmit it via the wireless communication interface, allowing an external computing device to analyze the user's comprehensive pelvic health profile (or pelvic pain health state). The external computing device could use Al algorithms to analyze the user's comprehensive pelvic health profile. The external computing device could be a smartphone running a dedicated software application. The analysis of the user's comprehensive pelvic health profile could be (partially or fully) be realized by a server connected to the dedicated software application running on the smartphone.

[0109] Furthermore, the device 1 may be configured to control the electrostimulation based on the collected sensor data of the one or more sensors. Thus, the device 1 may be operated in a closed-loop mode, wherein the parameters of the electrostimulation signal (e.g., intensity and / or frequency) are automatically adjusted in real-time based on the collected sensor data. For example, the stimulation intensity can be increased upon detection of a strong contraction (detected via the contraction sensor). In another example, the stimulation signal can be adjusted in response to an inflammatory spike (e.g. detected via the temperature sensor).In the first embodiment shown in Fig. 1, the signal generation means or the PCB 10 and the battery 11 are arranged in the removal protrusion 3. The removal protrusion 3 extends in the (horizontal) plane of the ring-shaped rim 4 (radially from the rim 4) at the first side 6 opposed to the electrodes 8. The connection point between the rim 4 and the removal protrusion 3 is very thin and / or provides a maximum flexibility / bendability of the removal protrusion with respect to the rim 4. A rigid PCB 10 is connected via a conductor 9 to the electrodes. A first conductor 9 extends from the PCB 10 of the removal protrusion 3 through one side (on the third side of device 1 ) of the rim 4 to the first electrode 8. A second conductor 9 extends from the PCB 10 of the removal protrusion 3 through the other side (on the fourth side of device 1 ) of the rim 4 to the second electrode 8. The conductor 9 is realized here as two conductor tracks 9 extending on a flex PCB. The flex PCB has a first portion which is arranged in the removal protrusion 3 with the first and second conductor tracks. The first portion of the flex PCB bifurcates into two arms, with each arm extending on opposed sides of the rim 4 to the respective electrodes. When the width of each arm is small, the arm behaves in flexibility terms, like a wire. Thus, the first conductor track extends on the first arm to the first electrode 8 and the second conductor track extends on the second arm to the second electrode 8. Furthermore, the first and second arm could be embedded in the (silicone) rim 4 so that the rim material insulates the conductor tracks 9. The flex PCB comprising the conductor tracks 9 may be connected to a separate rigid PCB 10. Alternatively, the rigid PCB 10 and the flex PCB comprising the conductor tracks 9 may be realized as a single rigid-flex PCB. It is also possible to realize the PCB 10 as flex PCB as well and to arrange the signal generation means and the conductor tracks 9 all on the flex PCB. The first portion of the flex PCB 9 connects preferably also the battery 11. However, the conductors 9 could also be realized as wires 9‘ as in Fig. 3. The electrodes 8 are preferably realized as conductive silicone or as another conductive elastic or elastomeric material . The conductor track 9 ends in the portion of the rim 4 comprising the electrodes 8. In these portions, the conductor track 9 or its flex PCB is embedded in a conductive silicone so that the stimulation signal from the conductor track 9 is applied to the respective electrode 8. However, it is also possible to use metal electrodes as in Fig. 3. The metal electrodes could also be combined with the conductor tracks of the flex PCB or the wires 9‘ of Fig. 3 instead of the electrodes 8 realized as conductive silicone.

[0110] Fig. 3 shows a variation of the first embodiment in which the battery 11 is mounted directly on the PCB 10.

[0111] Fig. 2 shows a second embodiment of the intravaginal device 1. The removal protrusion 3‘ in the second embodiment extends downwards or substantially parallel to thereceptacle axis. The receptacle 2 is also connected to the removal protrusion 3 so that the removal protrusion 3‘ is prevented from being bent upwards. Preferably, the side of the removal protrusion 3‘ pointing / facing away from the receptacle 2 is connected to the rim 4. Preferably, the side of the removal protrusion 3 pointing towards the receptacle 2 is connected to the lateral wall of the receptacle 2. Here, the electrodes 8‘ are realized as metal electrodes 8‘ , although other electrodes could be used, e.g. the conductive silicone electrodes 8 from Fig. 1. The electrodes 8 or 8‘ are connected with wires 9‘ with the signal generation means or the PCB 10 in the removal protrusion 3‘. The same wires 9‘ are used to connect the battery 11 in the removal protrusion 3‘ with the PCB 10. The first wire extends from the first electrode 8‘ through the (third side of the) rim 4 to the removal protrusion 3‘. The second wire extends from the second electrode 8‘ through the (fourth side of the) rim 4 to the removal protrusion 3‘.

[0112] In the variant of the second embodiment shown in Fig. 4, the cylindrical battery is arranged in a rotated position or orientation. In Fig. 2, the cylinder axis is arranged in the first direction, while in Fig.4, the cylinder axis of the battery 11 is arranged substantially parallel to the vertical direction or to the longitudinal direction aligned with the longitudinal axis of the removal protrusion 3‘ or to the direction of the receptacle axis. Another small difference is that along the connection line of the lateral wall of the receptacle 2 and the side of the removal protrusion 3‘ pointing towards receptacle 2, the thickness of the removal protrusion 3‘ is reduced by a recess or notch 17. This increases the capability of the removal protrusion 3‘ to bend and might facilitate the removal of the body from the vagina.

[0113] While the receptacles 2 in the first and second embodiment were designed for receiving 60 ml, the receptacles in the third and fourth embodiment are designed smaller, here for 40 ml. However, other sizes of the receptacles 2 are possible without any limitation of the invention.

[0114] The third embodiment in Fig. 5 has a removal protrusion 3‘ similar as in the second embodiment. The removal protrusion 3‘ is additionally connected at its lateral sides with the lateral wall of the receptacle 2. This forms a pocket 16 between the lateral wall of the receptacle 2, the flaps 15 and the removal protrusion 3‘. Here the battery 11 is mounted directly on the PCB 10 arranged in the removal protrusion 3‘. Since the battery 11 points towards the pocket 16, the component does not create discomfort for the woman. In the third embodiment, the electrodes are realized as conductive silicone as in the first embodiment in Fig. 1 and the conductor 9‘ as wires as in the second embodiment in Fig. 2.

[0115] In the fourth embodiment illustrated in Fig. 6, the rim 4 starts from the third and fourth side to extend more downwards the closer you get to the first side 6 of the rim. In otherwords, the rim 4 is configured to extend progressively downwards from the third and fourth sides as it approaches the first side 6 of the rim 4. The rim 4 extending downwards resembles a collar which extends parallel to the lateral wall of the receptacle 2. Thus, the rim 4 on the first side 6 forms thus a removal protrusion 3 and / or generates a pocket 16 between the lateral wall of the receptacle 2 and the rim 4 or the removal protrusion 3. The electrodes 8‘ are realized as metal electrodes 8‘ and the conductors 9‘ as wires. The PCB 10 with the battery 11 and the antenna 14 are arranged in the lateral wall of the receptacle 2 at the first side 6 so that the components of the PCB are pointing or facing into the pocket 16.

[0116] In the fifth embodiment illustrated in Fig. 9, the battery 11 is arranged in the bottom 12 of the receptacle 2. The PCB 10 is arranged in the lateral wall of the receptacle 2 on the first side 6. Preferably, the antenna 14 is arranged in the removal protrusion 3.

[0117] In the sixth embodiment illustrated in Fig. 10, removal protrusion 3 extends not from the rim 4, but from the bottom side 12 of the recipient 2. This allows to arrange parts of the electronics in the bottom side 12 of the receptacle 2 and the removal protrusion 3 and to connect the electrodes 8 at the second side 6 with conductors 9 extending from the bottom side 12 to the second side 7 of the rim 4 along the lateral wall of the receptacle 2. For example, in the shown embodiment, the battery 11 is arranged in the bottom 12 of the receptacle 2 as in Fig. 9 and / or the PCB 10 is arranged in the removal protrusion 3. The PCB 10 and the conductors 9 are arranged by one flex PCB.

[0118] The seventh embodiment in Fig. 11 shows an intravaginal device 1 ‘ which is positioned closer to the opening 23 of the vagina in contrast to the intravaginal devices 1 shown in Fig. 1 to 6 and Fig. 8 to 10. The intravaginal device 1 ‘ is positioned in the vaginal canal 22 (below the cervix 27) as shown in Fig. 7. The shape of the intravaginal device 1 ‘ is like a menstrual cup and / or is bell or funnel shaped. The removal protrusion 3 is arranged at the bottom side 12 at the centre of the receptacle 2 extending in the vertical direction. This embodiment may offer some advantages in terms of comfort as it is not inserted that deep, but has some disadvantages for the pelvic pain treatment as the electrodes are at a greater distance from the posterior fornix 25.

[0119] While the intravaginal device has been primarily described herein as an intravaginal collecting hygiene device, it is also envisioned that the intravaginal device may be configured as a contraceptive device, such as a contraceptive diaphragm or a contraceptive cup, incorporating the electrostimulation means as described above. Analogous to the intravaginal device described previously, the contraceptive device comprises a rim and electrodes arranged in or on the rim of the contraceptive cup or diaphragm.It should be understood that the present invention is not limited to the described embodiments and that variations can be applied without going outside of the scope of the claims.

Claims

25CLAIMS1. Collecting menstrual hygiene device for treating pelvic pain and for collecting vaginal fluids, the collecting menstrual hygiene device comprises:a body configured to be placed in a vagina, the body comprising:a ring-shaped rim (4) made of an elastic material configured to press against a vaginal wall of the vagina and to seal the body against the vaginal wall, when placed in the vagina, anda closure means (2) closing the surface area within the ring-shaped rim to block a passage of the vaginal fluids through the vagina and forming a receptacle (2) to collect the vaginal fluids; andelectrostimulation means configured to stimulate the vaginal wall to treat pelvic pain, wherein the electrostimulation means comprises at least one electrode (8, 8') arranged in the rim (4).

2. Collecting menstrual hygiene device according to claim 1, wherein the body is configured to be inserted in a compressed state of the elastic ring-shaped rim (4), and the elastic ring-shaped rim (4) is configured to exert an outward radial pressure against the vaginal wall, when re-expanding towards its original shape.

3. Collecting menstrual hygiene device according to claim 1 or 2, wherein the closure means (2) forms a vaginal fluid impermeable film or barrier.

4. Collecting menstrual hygiene device according to claim 3, wherein the closure means (2) or vaginal fluid impermeable film or barrier is connected at its peripheral sides to the rim such that the vaginal fluid cannot pass through the body in between the rim.

5. Collecting menstrual hygiene device according to anyone of claims 1 to 4, wherein the collecting menstrual hygiene device being a menstrual disc.

6. Collecting menstrual hygiene device according to anyone of claims 3 to 5, wherein the closure means (2) or body has a diameter between 50 mm and 100 mm.

7. Collecting menstrual hygiene device according to one of claims 1 to 6, wherein the body is designed such that a first side of the rim (4) is positionable at a vaginal fornix sealing the vagina.

8. Collecting menstrual hygiene device according to one of claims 1 to 7, wherein the body comprises a removal protrusion (3) configured to facilitate the removal of the collecting menstrual hygiene device.

9. Collecting menstrual hygiene device according to claim 8, wherein the removal protrusion (3) protrudes or extends from the rim (4).

10. Collecting menstrual hygiene device according to claim 9, wherein the removal protrusion (3) is attached bendable at the rim (4) so that the angle between removal protrusion (3) and an axis of the receptacle (2) is variable.

11. Collecting menstrual hygiene device according to one of claims 1 to 10, wherein the rim (4) is thicker than the closure means (2) so that the rim (4) has a higher rigidity than the closure means (2).

12. Collecting menstrual hygiene device according to one of claims 1 to 11, wherein the body is made of an elastomer, wherein the at least one electrode (8, 8')is realized in conductive elastomer embedded in the elastomer of the body.

13. Collecting menstrual hygiene device according to one of claims 1 to 12, wherein the electrostimulation means comprises a power source, electronics and a conductor means, wherein the conductor means are configured to connect the electronics with the at least one electrode, wherein the electronics are configured to receive the power from the power source and to generate an electrical stimulation signal at the at least one electrode to stimulate the vaginal wall.

14. Collecting menstrual hygiene device according to claim 13, wherein the conductor means extends along the ring-shaped rim (4).

15. Collecting menstrual hygiene device according to claim 13 or 14, wherein the conductor means is realized as a conductor track of a flexible printed circuit board.

16. Collecting menstrual hygiene device according to one of claims 13 to 15, wherein the electronics and / or the power source is arranged in a removal protrusion of the body.

17. Collecting menstrual hygiene device according to one of claims 1 to 16, wherein the body with the ring-shaped rim and the closure means is made of elastomeric material.

18. Collecting menstrual hygiene device according to one of claims 1 to 17, wherein collecting menstrual hygiene device is non-absorbent or is vaginal fluid impermeable.

19. Collecting menstrual hygiene device according to one of claims 1 to 18 comprising a sensor for measuring a sensor parameter, wherein the electrostimulation means is configured to control the electrostimulation signal based on the measured sensor parameter.

20. Collecting menstrual hygiene device according to one of claims 1 to 19 comprising a sensor for measuring a physiological or biomechanical sensor parameter of a pelvic region and a wireless communication interface configured to send the measured sensor parameter to an external device.

21. Collecting menstrual hygiene device according to claim 1 or 20, wherein the sensor comprises one or more of :a pH sensor configured to measure an acidity level of a vaginal environment, an inertial measurement unit configured to detect user activity, posture, or pelvic movement,a temperature sensor configured to detect local temperature variations indicative of inflammation, ovulation, or infection,a contraction sensor configured to monitor pelvic floor muscle activity, the contraction sensor comprising a pressure sensor and or an electromyography sensor, a bio impedance sensor configured to analyze tissue characteristics or properties of vaginal fluids.

22. Collecting menstrual hygiene device according to one of claims 1 to 21, wherein the at least one electrode comprises two electrodes on the rim (4) extending each along the rim 4 for a circular length of more than 30°.

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