A supportive device for insertion into a vaginal canal of a human

Abstract

The invention relates to a device for insertion into a vaginal canal of a human, said device is configured to provide support along a front and back wall of said vaginal canal in an extent including an upper and lower end of said vaginal cavity, to restore a anatomy of the vaginal canal, said device comprising a body portion made of resilient material having a horizontal extension, a medial extension, a frontal extension, and an interior cavity (2) provided within said body portion, wherein said medial extension is smaller than said horizontal and frontal extensions, and wherein the device can be fully housed within said vaginal canal.

Description

[0001] A SUPPORTIVE DEVICE FOR INSERTION INTO A VAGINAL CANAL OF A HUMAN

[0002] FIELD OF THE INVENTION

[0003] The invention relates to a device for insertion into a vaginal canal of a human, said device is configured to provide support along a front and back wall of said vaginal canal in an extent including an upper and lower end of said vaginal cavity.

[0004] BACKGROUND OF THE INVENTION

[0005] A high proportion of females worldwide suffer from one or more of the physical conditions: pelvic organ prolapse / tissue collapse, rectocele and / or urinary incontinence. Such physical conditions are unpleasant for those affected as they give rise to many symptoms, such as pain, discomfort and bowel emptying difficulty (obstructed defecation). If surgery is used to alleviate the physical condition, the procedure is highly delicate as the risk of re-surgery and / or causing unwanted side-effect(s) is high.

[0006] Further, with the physical condition(s) follows a stigmatisation of the female, as the physical condition(s), although being well described in medical literature, is often thought of as something to be ashamed of.

[0007] Accordingly, as surgery may not be a viable option and there is a need for reducing the discomfort related to the physical condition(s), it would be advantageous to find a way to at least mitigate the symptoms related to the physical condition.

[0008] OBJECT OF THE INVENTION

[0009] In particular, it may be seen as an object of the present invention to provide a minimal invasive measure to, at least, mitigate discomfort and / or symptoms related to vaginal collapse, rectocele and / or urinary incontinence.

[0010] SUMMARY OF THE INVENTION

[0011] Thus, the above described object and several other objects are intended to be obtained in a first aspect of the invention by providing a device for insertion into a vaginal canal of a human, said device is configured to provide support along a front and back wall of said vaginal canal in an extent including an upper and lower end of said vaginal cavity, said device preferably comprises

[0012] • a body portion made from a resilient material and having o a horizontal extension, a medial extension, a frontal extension, and an interior cavity provided within said body portion; wherein

[0013] • preferably, said frontal extension, said horizontal extension and said medial extension have dimensions configuring the body portion to restore a anatomy of said vaginal canal when said device is arranged within said vaginal canal, and

[0014] • said medial extension is smaller than said horizontal extension and said frontal extension each has a dimension allowing the device to be fully housed within said vaginal canal.

[0015] Preferred embodiments of the device, is configured by its shape and resiliency to withstand the abnormal pressure introduced in the vaginal canal by bulging tissue.

[0016] Terms used herein are used in a manner being ordinary to a skilled person. Some of the used words are elucidated here below.

[0017] "Functional anatomy of a vaginal canal" typically refers to the anatomy of a vaginal canal being well functioning as provided by the support along a front and back wall of said vaginal canal in an extent including an upper and lower end of said vaginal cavity.

[0018] "Restoring" as used in "restoring functional anatomy of a vaginal canal" preferably refers to providing to the vaginal canal with support.

[0019] Devices according to preferred embodiments aim to alleviate discomfort associated with e.g. vaginal prolapse, rectocele and / or stress urinary incontinence. Such conditions are typically associated with that the anatomy of the vaginal canal is not functional in the sense that the size and / or shape of the vaginal canal is not functional. The inventors have realized that by introducing a device according to the first aspect of the invention into a vaginal canal, the functional anatomy of the vaginal canal can be restored. In this regard, the inventors have realized that a device being rotational symmetric around a median direction is not particularly useful for restoring the functional anatomy of the vaginal canal.

[0020] Horizontal plane, frontal plane and medial plane are defined in Fig. 1. Directions in these planes are defined as a direction in one of these planes, e.g. a horizontal direction, where these directions form an orthogonal set of directions. These directions, frontal direction, horizontal direction and medial direction, are also defined in Fig. 1. Further a cross section is given relatively to one of the planes. E.g. as a horizontal cross sectional view is a cross section made in the horizontal plane.

[0021] BRIEF DESCRIPTION OF THE FIGURES

[0022] The present invention and in particular preferred embodiments thereof will now be described in more details with regard to the accompanying figures. The figures show ways of implementing the present invention and are not to be construed as being limiting to other possible embodiments falling within the scope of the attached claim set.

[0023] Fig. 1A illustrates left hand side in a semi-transparent 3-dimensional view a device according to a first embodiment. Right hand side illustrates planes used herein to disclose the device. Fig. IB illustrates in a horizontal cross sectional view a horizontal elongate cross section of the device illustrated in Fig. 1A. Fig. 1C is a frontal cross sectional view of the device of Fig. 1A, and Fig. ID is a top view of the device of Fig. 1A.

[0024] Fig. 2A illustrates in 3-dimensional view a device according to a second embodiment. Fig. 2B is a frontal view of the device of Fig. 2A. Fig. 2C is a frontal cross sectional view, Fig. 2D is a top view, and Fig. 2E is a horizontal cross sectional view of the device of Fig. 2A.

[0025] Fig. 3A illustrates in a top view a third embodiment of a device. Fig. 3B is a horizontal cross sectional view of the device of Fig. 3A. Fig. 4A illustrates in a top view a fifth embodiment of a device. Fig. 4B is a horizontal cross sectional view of the device of Fig. 4A. In Fig. 4B redirection of forces exerted by a rectocele bulge on the device towards the sides of the device is illustrated by labelled arrows.

[0026] Fig. 5A illustrates in a 3-dimensional view a sixth embodiment of a device. Fig. 5B is a frontal cross sectional view along the plane indicated by A-A of the device of Fig. 5A. Fig. 5C is horizontal cross section view.

[0027] Fig. 6A illustrated in a 3-dimensional view a seventh embodiment of a device. Fig. 6B is a top view, Fig. 6C is a sideview and Fig. 6D is a bottom view of the device of Fig. 6A. Fig. 6E is a median cross sectional view, Fig. 6F is a horizontal cross sectional view of the device of Fig. 6A

[0028] Fig. 7 is a is median cross sectional view seen in a medial plane of an eighth embodiment of a device.

[0029] Fig. 8A is a photograph illustrating an embodiment of a container for containing a device according to the present invention; the container is illustrated in a closed configuration. Fig. 8B is a photograph illustrating the embodiment of Fig. 8A where the container is in an open configuration;

[0030] Fig. 9A is a photograph illustrating an embodiment of a container configured as an air drying receptacle for receiving a device according to the present invention; the container is illustrated in a closed configuration. Fig. 9B is a photograph illustrating the embodiment of Fig. 9A where the container is an in open configuration;

[0031] Fig. 10A illustrates in a 3-dimensional view a ninth embodiment of a device according to the present invention. Fig. 10B is an illustration of the ninth embodiment seen in the medial plane (left) and a cross-sectional view of the device through the frontal plane (right). Fig. 10C is an illustration of the ninth embodiment seen in the frontal plane (left) and a cross-sectional view of the device through the median plane (right). Fig. 11A illustrates in a 3-dimensional view a tenth embodiment of a device according to the present invention. Fig. 11B is an illustration of the tenth embodiment as seen in the frontal plane (left) and a cross-sectional view of the device through the median plane (right). Fig. 11C is a closer view of parts of Fig. 11B.

[0032] Fig. 12A illustrates in a 3-dimensional view an eleventh embodiment of a device according to the present invention. Fig. 12B is an illustration of the eleventh embodiment as seen in the median plane. Fig. 12C are illustrations of crosssections of Fig. 12B through the frontal plane (left) and the horizontal plane (right).

[0033] Fig. 13A illustrates in a 3-dimensional view a twelfth embodiment of a device according to the present invention. Fig. 13B is an illustration of the twelfth embodiment as seen in the frontal plane (left) and a cross-section through the median plane (right).

[0034] Fig. 14A illustrates in a 3-dimensional view a twelfth embodiment of a device according to the present invention. Fig. 14B is an illustration of the twelfth embodiment as seen in the median plane (left) and a cross-section through the frontal plane (right).

[0035] Fig. 15 is a graph of a typical compression curve for a device according to the present invention.

[0036] DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS

[0037] Reference is made to Fig. 1 schematically illustrates a first embodiment according to the present invention. Before describing details of the first embodiment, reference is made to the right hand side of Fig. 1A which introduces planes used in general in the description of preferred embodiments. The planes used are adopted from anatomical planes of a human body and thereby the planes used also refers to the orientation of a device according to the invention when inserted into a vaginal canal of a female. Specifically, Fig. 1 illustrates a first embodiment of a device that is configured to provide support along a front and back wall of said vaginal canal in an extent including an upper and lower end of said vaginal cavity. As illustrated, the device comprises a body portion 4. As will be apparent in the following, the device may, optionally, also comprise an outwardly tapering portion 15 and / or an inwardly tapering portion 16.

[0038] The body portion 4 is made from a resilient material. The resiliency of the material is, inter alia, to allow for folding the body portion 4 and the outwardly and inwardly tapering portion in the median plane so as to reduce the dimension in the frontal and horizontal plane, thereby easy insertion of the device into the vaginal cavity. The resiliency of the material should also allow for unfolding inside the vaginal cavity and exert a pressure on the interior wall of the vaginal cavity.

[0039] The body portion 4 has a horizontal extension 6, a medial extension 7, a frontal extension 5 having dimensions detailed below. The body portion also has an interior cavity 1 provided within said body portion 4. By this, the body may be described as a tubular element. The purpose of the cavity is inter alia to reduce the weight of the device, but also to provide local flexibility to the wall making up to allow for the wall to adopt to shape of the vaginal cavity.

[0040] The frontal extension 5, the horizontal extension 6 and the medial extension 7 have dimensions configuring the body portion 4 to restore a functional anatomy of vaginal canal when the device is arranged within the vaginal canal. This preferably means that preferred embodiments of the device essentially abuts side walls the vaginal cavity, and acts as an internal support structure where the vaginal cavity is supported. E.g. an inward bulge in the horizontal direction, as is the case with rectocele, is "flattened" whereby the functional anatomy of the rectum is restored as a consequence of shaping the anatomy of the vaginal canal.

[0041] To provide a widening of the vaginal canal and at the same time shaping the vaginal canal, the medial extension 7 is smaller than the horizontal extension 6. In addition, it is often preferred that the body portion 4, or the device in general, is fully contained within the vaginal canal, and the frontal extension 5 has accordingly a dimension allowing the device to be fully housed within the vaginal canal.

[0042] The embodiment of Fig. 1, besides having a medial extension 7 being smaller than the horizontal extension 6, one or more horizontal cross sections of the body portion 4 being elongate cross sections 8. Fig. IB schematically illustrates one example on elongate cross section 8. As illustrated, such a elongate cross section preferably has the form of a rounded trapezoid, where rounded here refers to that the corners in the trapezoid are not sharp corners by rounded so as to following e.g. the circumference of a circle section.

[0043] The two parallel sections of the rounded trapezoid form a first wall section 9 and a second wall section 10, and the two non-parallel sections of said rounded trapezoid form a third wall section 11 and a fourth wall section 12, which wall sections make up an exterior wall of the body portion 4. It is noted that the wall sections typically uninterruptedly form the exterior wall of the body portion 4.

[0044] As will become clear from the following, the one or more horizontal cross sections may be oval shaped, such as the oval shape illustrated in Fig. 2E.

[0045] In the embodiment of Fig. 1, the body portion 4 has essentially the same horizontal cross section through out the frontal extension of the body portion 4, although the invention is not limited to this.

[0046] The wall sections 9, 10, 11, 12 in the embodiment of Fig. 1 each has substantially a uniform thickness and the uniform thicknesses of each wall section are substantially equal to each other.

[0047] In order to increase the device's stiffness in the medial direction, the body portion 4 may be provided with a beam portion 13. The beam portion is typically made from the same material from which the device is made from. The beam portion extends within the interior cavity in a medial direction between two opposing walls of the body portion 4. As the beam portion 13 extends in the horizontal direction, wall sections of the body portion facing in horizontal direction will have a lower tendency to flex inwardly into the internal cavity as such inward flexing would require a compression of the beam portion 13. This reduced flexing has been found to further increase shaping of the vaginal canal and further assist in restoring e.g. the functional anatomy of the rectum. As an example, functional anatomy may be that when the bulging of the rectum is corrected it improves bowel emptying (similar to when people are advised to lift their knees for easier bowel emptying).

[0048] The beam portion may be given a number of different shapes, although the beam portion 13 preferably has a cross section having a larger frontal extension than a horizontal extension. By this, the support of the beam portion 13 acts on a longer frontal extension than horizontal extension, which may increase the likelihood of positioning the device in such a manner that it e.g. "flattens out" a bulge extending inwardly in medial direction in the vaginal cavity. A preferred shape of a frontal cross section is an elliptical cross section as clearly visible in Fig. 1C, where the longer elliptic's axis extends in the frontal direction.

[0049] Instead of extending between two opposing walls of the body without bifurcation(s) as illustrated in Fig. 1, the beam may comprise a beam portion as illustrated in Fig. 3. As perhaps most clearly visible, in the horizontal cross sectional view of Fig. 3b, the beam portion has a horizontal cross sectional view being X-shaped, hence the beam portion 13 is referred to as an X-beam 13. The X-beam has two pair of legs 24 extending inside the cavity and converge into a center portion. The X-beam 13 is preferably symmetric in the horizontal plane 30 in the medial direction. Between the legs 24, a void 23 is provided whereby the body portion 4 has a central region being more flexible compared to the flexibility of the portion from which the legs 24 depart. Further, since the legs 24 converge toward the center portion, a force applied in medial direction on one side of the body portion 4 will be transformed into a force having a sideway directed component, that is a force component acting in the horizontal direction. This has inter alia the advantage that since there is mainly soft tissue to the side of the pelvis, the force is not redirected to the bladder, bowels or other organs

[0050] As illustrated in Fig. 2C, the body portion may curve inwardly in the frontal plane 31. Further, as shown inter alia in Fig. 2E, the device may preferably be ovalshaped. The oval shape has turned out to be beneficial in the sense that a pressure on the side of the vaginal canal affects less nerve endings and more connective tissue, contrary to a pressure front and rear where the bladder and rectum are located upwardly in the vaginal canal.

[0051] In order to increase transformation of the force applied in the horizontal direction to sideway (horizontal direction), the device may have a Y-beam 18 as illustrated in Fig. 4. The Y-beam 18 is perhaps most clearly visible in the horizontal cross sectional view of Fig. 4b. The Y-beam 18 has a singular portion 25 extending in the medial plane 32 inside the interior cavity from a wall. This singular portion 25 bifurcates centrally inside the interior cavity 1 into two legs 24, where each of the legs 24 extends and turns into the horizontal plane 31 to opposite walls of the body portion 4. As schematically illustrated in Fig. 4B, a rectocele bulge will provide a pressure in the region where the singular portion 25 is connected with the wall, and as the legs 24 turn into the horizontal plane 31 this pressure results in a force directed to the sides, that is in the horizontal direction.

[0052] It is generally preferred that a preferred embodiment of a device has an upper opening 2 into the interior cavity 1. An example of such an upper opening 2 is disclosed in the Figs. 1-7. The opening 2 serves inter alia the purpose of receiving a part of the cervix in the opening and the opening 2 is shaped and dimensioned accordingly. By the opening receiving the cervix, is has been found that discomfort during use of the device has at least to some extent been mitigated and / or the device will provide a better fit inside the vaginal cavity thereby at least to some extent mitigating the risk of dislocation of the device during use.

[0053] To further improve the comfort, the upper opening 2 can be provided in a upper collar portion 14 where the upper collar portion 14 preferably is torus shaped.

[0054] As illustrated perhaps most clearly in Fig. 1A, the upper collar portion 14 is connected with the body portion 4 by a tubular outwardly tapering portion 15. By this, the device has a larger exterior form than the body portion 4 which has been found to improve receipt of a section of cervix, which in turn has been found to improve the comfort and / or further mitigate the risk of dislocating the device during use. As disclosed inter alia in Fig. 1, a device may have a lower opening 3 into said interior cavity 1. The lower opening 3 like the upper opening 2 provides a passage into the interior cavity 1. By this, the device may be considered as a tubular element which a fluid may flow through. This has inter alia the advantage that fluid, such as body liquid and gas, which could otherwise be trapped inside the interior cavity 1 and possibly affect the flexibility of the device, will not be trapped inside the interior cavity.

[0055] In other embodiments, the device has a closed lower end (not illustrated) and an upper opening, such as an upper opening 2 disclosed herein. By this, the device forms a receptacle which can be used to collect fluid during menstrual period which at same time provides support to the vaginal canal

[0056] In the embodiments illustrated in Figs. 1-7, the lower opening 3 is provided at a lower end of a tubular shaped inwardly tapering section 16 extending from a lower end of said body portion 4. However, if a device does not have the inwardly tapering section 16, the lower opening is typically provided at a lower end of the body portion 4.

[0057] Reference is made to Figs. 2, 3 and 4 in particular. These figures illustrates that the body portion 15 may be outwardly tapering in horizontal direction. By outwardly tapering in horizontal direction is typically meant that the horizontal extension 6 of the body portion 15 increases in upward direction. Such a outwardly tapering of the body portion may provide a better comfort for the user while still providing support to the vaginal canal.

[0058] Reference is made to Fig. 5 in particular. Fig. 5 illustrates a device according in which the body portion 5 has a fore and rear wall 27a and 27b both extending in a frontal plane 31 and both having an essential flat outer surface. The fore and rear wall 27a and 27b are connected with side walls 28 extending in a median plane 32. As illustrated, the side walls 28 each has a curved outer surface. As can be realized from the cross section view of Fig. 5C, the thickness of the side wall is larger than the thickness of the fore and rear wall 27a and 27b. By this, the device will have a relative high resistance against torsion and bending while the relatively thinner fore and rear wall 27a and 27b still provides flexibility and thereby comfort for the user.

[0059] Reference is made to Fig. 6 in particular. Fig. 6 illustrates a device in which the outwardly tapering portion 15 comprises a one-sided overhang portion 29. Here, one-side typically refers to that the overhang extend in direction only to one side of the device. In Fig. 6A and 6C the overhang portion 29 is indicated by the dotted lines and from this in can be seen that the overhang portion 29 extends in median direction beyond a frontal plane 31 (indicated by a solid line in Fig. 6C) of an outer surface of a rear wall 27b of the body portion 5.

[0060] Such an overhang portion 29 provides in general a device having a longer rearward extension than a forward extension.

[0061] Reference is made to Fig. 7 which illustrates an eighth embodiment of a device according to the invention. The embodiment is illustrated a median cross section view. The embodiment of Fig. 7 has similarities with the embodiment of Fig. 6, such as the overhang portion 29, although the embodiment of Fig. 7 differs from the embodiment in Fig. 6 in the following manner. The beam portion 13 is curved upwardly in the direction towards the upper opening 2, such that the middle of the beam portion 13 is closer to the upper opening 2 than the ends of the beam portion 13. Such an upwardly curving of the beam portion 13 has the advantage of providing a more smooth flexing in medial direction compared with the straight beam portion 13 of Fig. 6. Another advantage is that it allows for a better grip by a user during retraction of the device. Upon retraction of the device from the vaginal cavity a user introduces a finger into the interior of the device through the lower opening 3 to grip the device at the lower collar portion 34 wherein said lower opening 3 is provided. Access is improved compared e.g. with device of Fig. 6, since the volume below the beam member 13 is made larger due to the upwardly curved beam member.

[0062] As also seen from Fig. 7, the body portion may be inwardly in the frontal plane, by having a section 37 being inwardly curving, typically at the middle of the device. In addition, the lower collar portion 34 has a triangular cross section whereby an interior ledge 35 is provided which increases the grip by a finger and allows for an easy retraction of the device from the vaginal cavity.

[0063] The cross section of upper collar portion 14 in the embodiment of Fig. 7 varies along the perimeter of the upper collar portion 14. At a front position, the cross section 36a is essentially straight interior to the device and curved towards the interior at the exterior of the device as illustrated. At a rear position, the cross section 36b is generally rounded and has an overhang portion, overhanging the outwardly tapering portion 15. The change in cross section preferably occurs gradually e.g. without abrupt change in cross section.

[0064] Reference is made to Fig. 10, which illustrates a ninth embodiment of the device. In the ninth embodiment, the device is further provided with an extraction element 38 for facilitating extraction of the device from a vaginal canal. The extraction element 38 may be in the form of an elongate flexible member extending in a frontal direction towards the lower opening 3. The extraction element 38 may be configured to be gripped or engaged by at least one finger of a user, by the user inserting the at least one finger through the lower opening 3 of the device. The extraction element 38 may be pulled on by the user in order to move the device downward to another position within or fully out from the vaginal canal.

[0065] In preferred embodiments, the extraction element 38 extends from an interior portion of the body portion 4 of the device, such as from the beam portion 13, from at least one leg 24 of an x-beam 17, from at least one leg 24 or a singular portion 25 of a y-beam, or from an inside surface of a wall section 9, 10, 11, 12 of the device.

[0066] In preferred embodiments, such as illustrated in Fig. 10B, the extraction element 38 may be in the form of a loop. Thus, a user may grip or engage with the loop extraction element by the use of only a single finger to pull on or remove the device from a vaginal canal. The loop of the loop extraction element is substantially aligned with the frontal plane 31 or median plane 32. In some embodiments not illustrated herein, the extraction element 38 may be foldable. The foldable extraction element is configured to be in a folded position prior to and during insertion of the device, as well as when the device is positioned in the vaginal canal of a user. In the folded position, the extraction element is preferably contained fully within the interior cavity 1 of the device. For extracting and / or moving the device, the foldable extraction element may be unfolded to extend through the lower opening 3, such that one end of the foldable extraction element protrudes out from the interior cavity 1 through the lower opening 3. By protruding out from the interior cavity 1, the foldable extraction element may be substantially easier to reach by a finger of a user.

[0067] In some embodiments, the foldable extraction element may be in the form of a loop, where a first end of the loop of the foldable extraction element is fixedly attached to an interior portion of the body of the device, while a second end of the loop of the foldable extraction element is releasably attached to an interior portion of the body of the device. The second end of the foldable extraction element may be attached by means of an adhesive or a piece of material with lowered tensile strength. To allow for unfolding of the device, the adhesive or material is configured to release or break respectively, if the loop of the foldable extraction element is pulled on in a direction towards the lower opening 3.

[0068] In other embodiments, the foldable extraction element may be in the form of a string. A first end of the string is fixedly attached to an interior portion of the body of the device. A second end of the string may be releasably attached to an internal portion of the body of the device, or the string may be rolled or coiled up and configured to be pulled on to unroll and extend to pass through the lower opening 3.

[0069] Furthermore, the foldable extraction element may comprise a loop at an end thereof, such that the end loop of the foldable extraction element may be engaged by a single finger of a user after unfolding of the foldable extraction element, to move or extract the device from the vaginal canal.

[0070] In some embodiments, the device may comprise retention elements disposed on outward facing walls thereof. The retention elements are provided to increase the positional stability of the device within the vaginal canal by increasing the retention force between the vaginal canal and the device.

[0071] In some embodiments not illustrated herein, retention elements may be provided by patterning on the external surfaces of the device. The patterning may be in the form of protrusions and / or recesses spaced apart around the circumference and along the frontal direction to form a pattern of protrusions, the pattern extending in both longitudinal and circumferential directions along the outside of the device. The pattern of protrusions and / or recesses may be arranged to cover an outside surface of the device partially, such as partially around the circumference and / or along the length of the device. Preferably, a protrusion height of the protrusions and / or a recess depth of the recesses are smaller than the wall thickness of the device.

[0072] An example of retention elements is illustrated in Fig. 10, where retention elements are provided in the form of ridges 39 spaced apart on the outside surface of the device along the frontal direction of the device. The ridges 39 are formed around the full circumference of the device, such that at the horizontal plane where a ridge 39 is located, the device has an increased diameter of the horizontal cross-section. Closed spaces between the vaginal canal and the outer walls of the device are formed between neighbouring ridges 39. Preferably, the ridges 39 are formed closer to the lower opening 3 than the upper opening 2 of the device.

[0073] Reference is made to Fig. 11, which illustrates a tenth embodiment of the device. In the tenth embodiment, the retention elements are provided in the form of concave surfaces 40 in the form of dimples in outer surfaces of the device. The concave surfaces 40 may serve to cause pockets of negative pressure between the wall of the vaginal canal and the device, increasing the retention force. Negative pressure refers to that the pressure is lower at one point than another point. Preferably, the concave surfaces 40 may be formed on outer surfaces of the device at locations opposite ends of the beam member 13, 17, 18. By providing the concave surfaces 40 at outside surfaces opposite ends of the beam member 13, 17, 18, areas of reduced wall thickness are avoided. Therefore, potential differences in strength of the walls of the device in and around the concave surfaces 40 due to varying wall thicknesses are reduced.

[0074] Alternatively, a plurality of dimples may be provided in a pattern covering partially or fully an outside surface of the device to cause a plurality of pockets of negative pressure between the wall of the vaginal canal and the device.

[0075] During extraction of the device by a user, where a finger of the user is inserted through the lower opening 3 of the device during extraction, flow of fluid through the device may be substantially restricted. Hence, the force required to move the device and / or user discomfort during extraction may be increased due to increases in negative pressure forming between the device and the inside of the vaginal canal when the device is moved downwards in the vaginal canal. If the device is moved quickly during extraction or relocation, local negative pressures may cause considerable discomfort to the user.

[0076] Reference is made to Fig. 12, which illustrates an eleventh embodiment of the device. To prevent negative pressures from forming during extraction of the device from the vaginal canal, at least one wall portion 9, 10, 11, 12 of the device of the eleventh embodiment may comprise at least one aperture 41 to allow for flow of fluid through the at least one aperture 41 even when the lower opening 3 of the device is blocked by a finger of a user. When the device is resting in the vaginal canal, the apertures 41 may be in contact with a wall of the vaginal canal, such that flow of fluid through the device is only allowed through the upper 2 and lower 3 openings. During extraction, the at least one aperture 41 is not in contact with the vaginal canal due to stretching of the device, allowing flow of fluid through the apertures.

[0077] In preferred embodiments, the at least one aperture 41 is located closer to the lower opening 3 than the upper opening 2 of the device. Preferably, the at least one aperture 41 is located in the wall portion 9, 10, 11, 12 at a position along the frontal direction between the beam member 13, 17, 18 and the lower opening 3.

[0078] If the finger of the user blocking the lower opening 3 also occludes the at least one aperture 41 in the wall portion 9, 10, 11, 12 during extraction, fluid flow through the device may be substantially restricted. The at least one aperture 41 may also be blocked by a vaginal wall during extraction, if the user pushes on the device in the direction of the at least one aperture 41. In preferred embodiments, the device therefore comprises at least two apertures 41 located in at least two different wall portions 9, 10, 11, 12. Even if one of the at least two apertures 41 is blocked by a vaginal wall or the finger of the user, at least one of the at least two apertures 41 will be unblocked.

[0079] Even if the device is formed from an elastomer, the device may still cause some discomfort for a user during movement. In particular, the device may cause localised pressure on vaginal innervation zones, especially when a user moves or after a user has changed positions.

[0080] Reference is made to Fig. 13, which illustrates a twelfth embodiment of the device. In the twelfth embodiment, the perimeter of the lower opening 3 may be configured to avoid increasing localized pressure on the vaginal innervation zones. In particular, the perimeter of the lower opening 3 may be a circular, oval or elliptical opening when seen in the horizontal plane, comprising at least one arch or undulation 42.

[0081] In some embodiments not illustrated, the perimeter of the lower opening 3 comprises a plurality of undulations disposed circumferentially around the lower opening. By providing a plurality of undulations, it is possible to avoid increasing localized pressure on a plurality of vaginal innervation zones.

[0082] Providing an undulated geometry of the lower opening 3, may also aid in preventing device extrusion during user movement. Furthermore, the undulated geometry of the lower opening 3 may also ease the insertion of a finger of a user into the lower opening during insertion, adjustment or extraction of the device.

[0083] In some embodiments, an overhang portion 29 may be configured to aid in positional stability of the device. For example, by providing the overhang portion 29 in the form of an upper edge of the device protruding in a horizontal direction, the positional stability of the device when inserted in a vaginal canal may be improved. Preferably, the overhang portion 29 is configured to be positioned within a posterior fornix of the user. After insertion, a part of the device will therefore be retained between the cervix / uterus and the posterior vaginal wall, substantially preventing displacement of the device.

[0084] Reference is made to Fig. 14, which illustrates a thirteenth embodiment of the device. In the thirteenth embodiment, an overhang portion 29 is provided due to the centre of the upper opening 2 being displaced in a horizontal direction in relation to the centre of the lower opening 3, such that one edge of the upper opening 2 protrudes in a horizontal direction away from the centre axis of the device, where the centre axis of the device is an axis through the centre of and perpendicular to the lower opening 3. The upper opening 2 may be circular, oval or elliptical in shape, and the upper opening 2 may have a larger area than the lower opening 3. Both the upper 2 and lower 3 opening may have their centres in the same frontal plane 31. The upper 2 and lower 3 openings may be parallel to each other or angled in relation to each other.

[0085] As illustrated in Fig. 14B, where the overhang portion 29 is provided by the displacement of the upper opening 2, the displacement of the centre of the upper opening 2 may be larger than the difference between the radii of the upper 2 and lower 3 openings. If seen in the horizontal plane 30, the circumference of the lower opening 3 and the circumference of the upper opening 2 thus intersect each other. In such embodiments, the upper part of one outside wall towards which the upper opening 2 is displaced may comprise an overhang portion 29, while the upper part of the opposite outside wall 43 may curve in a horizontal direction towards the centre axis of the device, such as illustrated in Fig. 14B.

[0086] In some embodiments such as illustrated in Fig. 14A-B, the smallest angle between the overhang portion 29 and the horizontal plane 30 may be smaller than 90 degrees, preferably smaller than 45 degrees. The angle of the overhang portion 29 may be defined as an average or as a maximum angle of the overhang portion 29 to the horizontal plane 30. In embodiments where the upper part of the opposite outside wall 43 curves inwards towards the centre axis of the device, the smallest angle between the inward curving upper part 43 and the horizontal plane 30 is smaller than 90 degrees, preferably smaller than 45 degrees. Alternatively, if seen in the horizontal plane 30, the upper opening 2 may be displaced fully past the lower opening 3, such that the circumference of the lower opening 3 and the circumference of the upper opening 2 may be externally tangent or at a distance from each other if seen in the horizontal plane 30.

[0087] In some embodiments where the overhang portion 29 is provided by the displacement of the upper opening 2, the displacement of the centre of the upper opening 2 is smaller than the difference between the radii of the upper 2 and lower 3 openings. If seen in the horizontal plane 30, the circumference of the lower opening 3 is therefore fully within the circumference of the upper opening 2, such as illustrated in Fig. 6b and 6d.

[0088] The device is preferably made from a material having a modulus of elasticity within the range of 0.0005-1.0 GPa. In some preferred embodiments, the device is made from silicone, latex or polyvinyl chloride.

[0089] As illustrated in Fig. 15, the device typically comprises a non-linear compression profile. Fig. 15 is a result of compression testing of the device between two parallel plates aligned with the median plane 32 of the device. Initial deflection of the device from 0-18 mm requiring relatively low and constant force is due to deflection of the upper collar portion. Above 18 mm, the force required to compress the device further increases due to the body portion 4. Above 30 mm, the beam member 13, 17, 18 causes a steep increase in the force required to compress the device. Due to the beam member, the device is therefore substantially more likely to remain expanded and open to fluid flow through and between the upper 2 and lower 3 openings when in use, as higher force is required to compress the beam member 13, 17, 18 than the body of the device.

[0090] While a device according to the invention may be assembled, e.g. by gluing, from separate parts, such as a separate body portion 4, a separate outwardly tapering portion 15 and a separate inwardly tapering portion 16, it may be generally preferred that the device is a unitary body. Such a unitary body may be provided by moulding, where a pre-shaped for instance is made by 3D printing, and a mould is made from the 3D printed pre-shaped. The device being a unitary body may provide enhanced structural integrity as compared to a device assembled from parts. The unitary body device may have a reduced risk of breakage, in particular the risk of breakage of the device in places where the device would have otherwise required assembly by e.g. gluing or other joining means. Additionally, the unitary body device may exhibit increased reliability over a device assembled from parts, due to elimination of alignment issues introduced during joining of parts which could otherwise cause differences and / or inconsistency in mechanical properties at and around joining interfaces for devices assembled from parts. By elimination of joining interfaces, user comfort may also be improved.

[0091] Since the device is to be inserted into the vaginal cavity, discoloration may occur. To mitigate this, the device may be given a colour selected from blue, purple, turquoise or yellow, as it has been found that discoloration is not particularly visible for these colours.

[0092] As presented herein, a device is typically dimensioned to provide mechanical support to a vaginal canal. This also means that the flexibility of the device is sufficiently high to support the vaginal canal and at the same sufficiently low to prevent discomfort during use.

[0093] Preferred embodiments is configured to provide a mechanical support to the vaginal canal to an extend which introduces, restores, or augments anatomical structure for the functional function of the vaginal canal, urinary tract, or rectum.

[0094] In preferred embodiments, a device according to the invention is used for vaginal prolapse.

[0095] In preferred embodiments, a device according to the invention is used for rectocele.

[0096] In preferred embodiments, a device according to the invention is used for enterocele. In preferred embodiments, a device according to the invention is used for cystocele.

[0097] In preferred embodiments, a device according to the invention is used for uterocele.

[0098] In preferred embodiments, a device according to the invention is used for stress urinary incontinence.

[0099] By "is used for" is meant that the device is introduced into the vaginal canal with an orientation relative to the human, so that the device's medial, frontal and horizontal directions when positioned in the vaginal canal matches the humans' medial, frontal and horizontal planes. In addition, in embodiments having the outwardly tapering portion 15, the device is housed in the vaginal canal to so that the cervix does not push the device downwards, which in inter alia is accomplished by at least a part of the cervix may be housed in the outwardly tapering portion 15. In embodiments not have the tapering portion 15, the device is introduced into the vaginal canal to an extend where the cervix abuts an upper part of the body portion 4.

[0100] The invention also relates to container 20 for containing a device according to present invention. On such embodiment is disclosed in Fig. 8. The disclosed embodiment an impermeable wall defining an interior void dimensioned to house a device according to the invention. The wall is divided into at least two parts 20A and 20B and releasable connected to each other so as to allow a device to be placed in the container, whereafter the container can be closed by mating the two parts with each other. In Fig. 8B it can be seen that the two cavities provided in the two halves 20A and 20B mate with the outer contour of the device illustrated in Fig. 1. If the container is to house another embodiment that the one of Fig. 1, such as the one of Fig. 6, the two cavities will typically be shaped so as to mate with the outer contour of that embodiment.

[0101] In preferred embodiments of the container 20, a plurality of through going openings 22 are provided in the impermeable wall so as to allow moisture to escape from said interior void. Such an embodiment is illustrated in Figs. 9A-9B, where Fig. 9A illustrates the container in a closed configuration and Fig. 9B illustrates the container in an open configuration with the embodiment of Fig. 1 placed in one 21b of the two halves 21a and 21b of the container. The through going openings allows inter alia for drying of the device when the device after cleaning has been placed in the container. The container also has larger (relatively the openings 22) through going openings at ends of the container. These larger through going openings 26 allow for an efficient drying of the interior of the device.

[0102] ITEMIZED LIST OF PREFERRED EMBODIMENTS

[0103] Item 1. A device for insertion into a vaginal canal of a human, said device is configured to provide support along a front and back wall of said vaginal canal in an extent including an upper and lower end of said vaginal cavity, said device comprising

[0104] • a body portion (4) made from a resilient material and having o a horizontal extension (6), a medial extension (7), a frontal extension (5), and an interior cavity (1) provided within said body portion (4); wherein

[0105] • said frontal extension (5), said horizontal extension (6) and said medial extension (7) have dimensions configuring the body portion (4) to restore an anatomy of said vaginal canal when said device is arranged within said vaginal canal, and

[0106] • said medial extension (7) is smaller than said horizontal extension (6) and said frontal extension (5) each has a dimension allowing the device to be fully housed within said vaginal canal.

[0107] Item 2. A device according to item 1, wherein one or more horizontal cross sections of said body portion (4) are elongate cross section (8) having the form of an oval (34), such as elliptic.

[0108] Item 3. A device according to item 1 or 2, wherein one or more horizontal cross sections of said body portion (4) are elongate cross sections (8) having the form of a rounded trapezoid, wherein

[0109] • two parallel sections of said rounded trapezoid form a first wall section (9) and a second wall section (10), and and two non-parallel sections of said rounded trapezoid form a third wall section (11) and a fourth wall section (12).

[0110] Item 4. A device according to any one of the preceding items, wherein said wall sections (9, 10, 11, 12) each has substantially a uniform thickness, said uniform thickness' being substantially equal.

[0111] Item 5. A device according to any one of the preceding items, comprising a beam portion (13) extending medially within said cavity (1) between to opposing walls of said body portion (4).

[0112] Item 6. A device according to item 5, wherein said beam portion (13) has a cross section having a larger frontal extension than a horizontal extension, such as having a elliptical cross section.

[0113] Item 7. A device according to item 5 or 6, wherein said beam portion (13) comprises an x-beam (17).

[0114] Item 8. A device according to item 5 or 6, wherein said beam portions (13) comprises a Y-beam (18).

[0115] Item 9. A device according to any one of the preceding items 5-8, wherein said beam portion (13) is curved upwardly.

[0116] Item 10. A device according to any one of the preceding items, wherein said device comprising an upper opening (2) into said interior cavity (1).

[0117] Item 11. A device according to item 10, wherein said upper opening (2) is provided in a upper collar portion (14), said upper collar portion (14) preferably being torus shaped.

[0118] Item 12. A device according to item 11, wherein said upper collar portion (14) has varying cross sections along a perimeter of the upper collar portion (14), where • at a front position, the cross section (36a) is essentially straight interior to the device and curved towards the interior at exterior of the device, and at a rear position, the cross section (36b) is generally rounded and has an overhang portion.

[0119] Item 13. A device according to item 12, wherein a change in said varying cross sections occurs gradually, such as without abrupt change in cross section.

[0120] Item 14. A device according to any one of the preceding items, wherein said body portion (4) has a section (37) being inwardly curved.

[0121] Item 15. A device according to any one of the preceding items 11-14, wherein said upper collar portion (14) is connected with said body portion (4) by a tubular outwardly tapering portion (15).

[0122] Item 16. A device according to any one of the preceding items, wherein said device comprising a lower opening (3) into said interior cavity (1).

[0123] Item 17. A device according to item 16, wherein said lower opening (3) is provided at an lower end of a tubular shaped inwardly tapering section (16) extending from a lower end of said body portion (4).

[0124] Item 18. A device according to any one of the preceding items 9-17, wherein said lower opening (3) is provided in a lower collar portion (34).

[0125] Item 19. A device according to item 18, wherein said lower collar portion (34) has a triangular cross section and provides an interior ledge (35).

[0126] Item 20. A device according to any one of the preceding items, wherein said body portion is outwardly tapering in horizontal direction

[0127] Item 21. A device according to any one of the preceding items, wherein said body portion (5) comprises a fore and rear wall extending in a frontal plane (31) and having an essential flat outer surface, said fore and rear wall being connected with side walls (28) extending in a median plane (32), said side walls having a curved outer surface. Item 22. A device according to any one of the preceding items, when dependant on item 15, wherein said outwardly tapering portion (15) comprising a one-sided overhang portion (29), wherein said overhang portion (29) extends in median direction beyond a frontal plane (31) of an outer surface of a rear wall (27b) of the body portion (5).

[0128] Item 23. A device according to any one of the preceding items, wherein said upper collar portion (14) is upwardly curved.

[0129] Item 24. A device according to any one of the preceding items, wherein said device is made from a material having an elastic modulus within the range of 0.0005-1.0 GPa.

[0130] Item 25. A device according to any one of the preceding items, wherein said device is made from silicone, latex or polyvinyl chloride.

[0131] Item 26. A device according to any one of the preceding items, wherein said device is a unitary body.

[0132] Item 27. A device according to any one of the preceding items, wherein said device is blue, purple, turquoise or yellow coloured.

[0133] Item 28. A device according to any one of the preceding items, wherein the device is dimensioned to provide mechanical support to a vagina canal.

[0134] Item 29. A device according to item 28, wherein said mechanical support introduces, restores, or augments anatomical structure for the functional function of the vaginal canal, urinary tract, or rectum.

[0135] Item 30. A device according to any one of the preceding items, wherein the device is used for vaginal prolapse.

[0136] Item 31. A device according to any one of the preceding items, wherein the device is used for rectocele. Item 32. A device according to any one of the preceding items, wherein the device is used for enterocele.

[0137] Item 33. A device according to any one of the preceding items, wherein the device is used for cystocele.

[0138] Item 34. A device according to any one of the preceding items, wherein the device is used for uterocele.

[0139] Item 35. A device according to any one of the preceding items, wherein the device is used for stress urinary incontinence.

[0140] Item 36. A device according to any one of the preceding items the device further comprising an extraction element (38) arranged on an interior surface of the device and protruding in a direction towards the lower opening (3).

[0141] Item 37. A device according to item 36, wherein the extraction element (38) is foldable, wherein the extraction element (38) is configured to be contained substantially within the interior cavity (1) in a folded state, and to protrude from the device through the lower opening (3) in an unfolded state.

[0142] Item 38. A device according to item 36 or 37, wherein the extraction element (38) comprises a loop.

[0143] Item 39. A device according to any one of the preceding items, the device further comprising a plurality of circumferential ridges (39) disposed on an outside surface thereof and spaced apart along a frontal direction.

[0144] Item 40. A device according to any one of the preceding items, the device further comprising a plurality of apertures (41) in at least one wall portion of the device.

[0145] Item 41. A device according to item 40, wherein the apertures (41) are located at a position along the frontal direction between the lower opening (3) and the beam portion (13). Item 42. A device according to any one of the preceding items, wherein the lower opening (3) comprises an undulated curvature.

[0146] Item 43. A device according to any one of the preceding items comprising a pattern of projections and / or cavities, the pattern at least partly covering an outside surface thereof.

[0147] Item 44. A device according to any one of the preceding items, the device further comprising at least one concave surface (40) disposed on an outside surface thereof.

[0148] Item 45. A device according to item 44, wherein the at least one concave surface (40) is disposed at a position on an outside surface opposite a position of at least one end of the beam portion (13) on an inside surface.

[0149] Item 46. A device according to item 22, wherein at least part of the overhang portion (29) is configured to be disposed within a posterior fornix of a user.

[0150] Item 47. A container (20) for containing a device according to any one of the preceding items, comprising an impermeable wall defining an interior void dimensioned to house said device, wherein said wall is divided into at least two parts and releasable connected to each other.

[0151] Item 48. A container according to item 47, wherein a plurality of through going openings are provided in said impermeable wall so as to allow moisture to escape from said interior void.

[0152] Item 49. A kit of parts comprising a device according to any one of the preceding items 1-46 and a container according to any one of the preceding items 47-48.

[0153] Although the present invention has been described in connection with the specified embodiments, it should not be construed as being in any way limited to the presented examples. The scope of the present invention is set out by the accompanying claim set. In the context of the claims, the terms "comprising" or "comprises" do not exclude other possible elements or steps. Also, the mentioning of references such as "a" or "an" etc. should not be construed as excluding a plurality. The use of reference signs in the claims with respect to elements indicated in the figures shall also not be construed as limiting the scope of the invention. Furthermore, individual features mentioned in different claims, may possibly be advantageously combined, and the mentioning of these features in different claims does not exclude that a combination of features is not possible and advantageous.

[0154] List of reference symbols used

[0155] 1 Interior cavity

[0156] 2 Upper opening

[0157] 3 Lower opening

[0158] 4 Body portion

[0159] 5 Frontal extension

[0160] 6 Horizontal extension

[0161] 7 Medial extension

[0162] 8 Elongate cross section

[0163] 9 First wall section

[0164] 10 Second wall section

[0165] 11 Third wall section

[0166] 12 Fourth wall section

[0167] 13 Beam portion

[0168] 14 Upper collar portion

[0169] 15 Outwardly tapering portion

[0170] 16 Inwardly tapering portion

[0171] 17 X-beam

[0172] 18 Y-beam

[0173] 20 Container

[0174] 20a First container part

[0175] 20b Second container part

[0176] 21 Drying receptacle

[0177] 21a First drying receptacle part

[0178] 21b Second drying receptacle part

[0179] 22 Through going openings

[0180] 23 Void

[0181] 24 Leg

[0182] 25 Singular portion

[0183] 26 Larger through going opening

[0184] 27a, b Fore and rear wall respectively

[0185] 28 Side wall

[0186] 29 Overhang portion

[0187] 30 Horizontal plane

[0188] 31 Frontal plane 32 Median plane

[0189] 33 Oval (cross section)

[0190] 34 Lower collar portion

[0191] 35 Interior ledge 36a Cross section of upper collar portion at a front position

[0192] 36b Cross section of upper collar portion at a rear position

[0193] 37 Inward curving of body portion in frontal plane

[0194] 38 Extraction element

[0195] 39 Ridge 40 Concave surface

[0196] 41 Aperture

[0197] 42 Undulation

[0198] 43 Upper part of opposite outside wall

Claims

CLAIMS1. A device for insertion into a vaginal canal of a human, said device is configured to provide support along a front and back wall of said vaginal canal in an extent including an upper and lower end of said vaginal cavity, said device comprising• a body portion (4) made from a resilient material and having o a horizontal extension (6), a medial extension (7), a frontal extension (5), and an interior cavity (1) provided within said body portion (4); wherein• said frontal extension (5), said horizontal extension (6) and said medial extension (7) have dimensions configuring the body portion (4) to restore a anatomy of said vaginal canal when said device is arranged within said vaginal canal, and• said medial extension (7) is smaller than said horizontal extension (6) and said frontal extension (5) each has a dimension allowing the device to be fully housed within said vaginal canal.

2. A device according to claim 1, wherein one or more horizontal cross sections of said body portion (4) are elongate cross sections (8) having the form of an oval (34), such as elliptic.

3. A device according to claim 1 or 2, wherein one or more horizontal cross sections of said body portion (4) are elongate cross sections (8) having the form of a rounded trapezoid, wherein• two parallel sections of said rounded trapezoid form a first wall section (9) and a second wall section (10), and• and two non-parallel sections of said rounded trapezoid form a third wall section (11) and a fourth wall section (12).

4. A device according to any one of the preceding claims, wherein said wall sections (9, 10, 11, 12) each has substantially a uniform thickness, said uniform thickness' being substantially equal.

5. A device according to any one of the preceding claims, comprising a beam portion (13) extending medially within said cavity (1) between to opposing walls of said body portion (4).

6. A device according to claim 5, wherein said beam portion (13) has a cross section having a larger frontal extension than a horizontal extension, such as having a elliptical cross section.

7. A device according to claim 5 or 6, wherein said beam portion (13) comprises an x-beam (17).

8. A device according to claim 5 or 6, wherein said beam portions (13) comprises a Y-beam (18).

9. A device according to any one of the preceding claims 5-8, wherein said beam portion (13) is curved upwardly.

10. A device according to any one of the preceding claims, wherein said device comprising an upper opening (2) into said interior cavity (1).

11. A device according to claim 10, wherein said upper opening (2) is provided in a upper collar portion (14), said upper collar portion (14) preferably being torus shaped.

12. A device according to claim 11, wherein said upper collar portion (14) has varying cross sections along a perimeter of the upper collar portion (14), where• at a front position, the cross section (36a) is essentially straight interior to the device and curved towards the interior at exterior of the device, and• at a rear position, the cross section (36b) is generally rounded and has an overhang portion.

13. A device according to claim 12, wherein a change in said varying cross sections occurs gradually, such as without abrupt change in cross section14. A device according to any one of the preceding claims, wherein said body portion (4) has a section (37) being inwardly curved.

15. A device according to any one of the preceding claims 11-14, wherein said upper collar portion (14) is connected with said body portion (4) by a tubular outwardly tapering portion (15).

16. A device according to any one of the preceding claims, wherein said device comprising a lower opening (3) into said interior cavity (1).

17. A device according to claim 16, wherein said lower opening (3) is provided at an lower end of a tubular shaped inwardly tapering section (16) extending from a lower end of said body portion (4).

18. A device according to claim any one of the preceding claims 9-17, wherein said lower opening (3) is provided in a lower collar portion (34).

19. A device according to claim 18, wherein said lower collar portion (34) has a triangular cross section and provides an interior ledge (35).

20. A device according to any one of the preceding claims, wherein said body portion is outwardly tapering in horizontal direction21. A device according to any one of the preceding claims, wherein said body portion (5) comprises a fore and rear wall extending in a frontal plane (31) and having an essential flat outer surface, said fore and rear wall being connected with side walls (28) extending in a median plane (32), said side walls having a curved outer surface.

22. A device according to any one of the preceding claims, when dependant on claim 15, wherein said outwardly tapering portion (15) comprising a one-sided overhang portion (29), wherein said overhang portion (29) extends in median direction beyond a frontal plane (31) of an outer surface of a rear wall (27b) of the body portion (5).

23. A device according to any one of the preceding claims, wherein said upper collar portion (14) is upwardly curved.

24. A device according to any one of the preceding claims, wherein said device is made from a material having an elastic modulus within the range of 0.0005-1.0 GPa.

25. A device according to any one of the preceding claims, wherein said device is made from silicone, latex or polyvinyl chloride.

26. A device according to any one of the preceding claims, wherein said device is a unitary body.

27. A device according to any one of the preceding claims, wherein said device is blue, purple, turquoise or yellow coloured.

28. A device according to any one of the preceding claims, wherein the device is dimensioned to provide mechanical support to a vagina canal.

29. A device according to claim 28, wherein said mechanical support introduces, restores, or augments anatomical structure for the functional function of the vaginal canal, urinary tract, or rectum.

30. A device according to any one of the preceding claims, wherein the device is used for• vaginal prolapse and / or• for rectocele and / or• for enterocele and / or• for cystocele and / or• for uterocele and / or• for stress urinary incontinence.

31. A device according to any one of the preceding claims, the device further comprising an extraction element (38) arranged on an interior surface of said device and protruding in a direction towards said lower opening (3).

32. A device according to claim 31, wherein said extraction element (38) is foldable, wherein said extraction element (38) is configured to be containedsubstantially within said interior cavity (1) in a folded state, and to protrude from said device through said lower opening (3) in an unfolded state.

33. A device according to claim 31 or 32, wherein said extraction element (38) comprises a loop.

34. A device according to any one of the preceding claims, said device further comprising a plurality of circumferential ridges (39) disposed on an outside surface thereof and spaced apart along a frontal direction.

35. A device according to any one of the preceding claims, said device further comprising a plurality of apertures (41) in at least one wall portion of the device.

36. A device according to claim 35, wherein said apertures (41) are located at a position along said frontal direction between said lower opening (3) and said beam portion (13).

37. A device according to any one of the preceding claims, wherein said lower opening (3) comprises an undulated curvature.

38. A device according to any one of the preceding claims comprising a pattern of projections and / or cavities, said pattern at least partly covering an outside surface thereof.

39. A device according to any one of the preceding claims, said device further comprising at least one concave surface (40) disposed on an outside surface thereof.

40. A device according to claim 39, wherein said at least one concave surface (40) is disposed at a position on an outside surface opposite a position of at least one end of said beam portion (13) on an inside surface.

41. A device according to claim 22, wherein at least part of said overhang portion (29) is configured to be disposed within a posterior fornix of a user.

42. A container (20) containing a device according to any one of the preceding claims, comprising an impermeable wall defining an interior void dimensioned to house said device, wherein said wall is divided into at least two parts and releasable connected to each other.

43. A container according to claim 42, wherein a plurality of through going openings are provided in said impermeable wall so as to allow moisture to escape from said interior void.

44. A kit of parts comprising a device according to any one of the preceding claims 1-41 and a container according to any one of the preceding claims 42-43..

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