A perineum damage-reducing device for reducing perineum damage during vaginal child delivery

Abstract

A perineum damage-reducing device (1) for reducing damage to a female human body during vaginal child delivery is disclosed. It comprises a first part (10) for insertion into the female human body via introitus vagina, and a second part (20) configured to extend out-side the female human body away from the posterior part of introitus vagina towards anus. An attachment element (34) for attachment to a surface of the female human body is provided on the second part. The first part is longer than the second part in the longitudinal direction, and a primary reinforcing element (41) extends along a centre axis of the first part, said centre axis being parallel with the longitudinal direction and centred on the first part in the width direction. A method for use of the device is also disclosed.

Description

[0001] Title

[0002] A PERINEUM DAMAGE-REDUCING DEVICE FOR REDUCING PERINEUM DAMAGE DURING VAGINAL CHILD DELIVERY

[0003] Technical Field

[0004] The present disclosure relates to a perineum damage-reducing device for reducing damage to a female human body during vaginal child delivery, said female human body comprising vagina, introitus vagina, perineum, and anus, and said perineum damage-reducing device comprising: a first part configured to be inserted into the female human body via introitus vagina at a posterior part of introitus vagina; a second part configured to extend outside the female human body away from the posterior part of introitus vagina towards anus; an attachment element configured for attachment to a surface of the female hu-man body; and a primary reinforcing element; where the second part extends in a continuation of the first part in a longitudinal direction of the perineum dam- age-reducing device, where the first part and the second part extend in a width direction perpendicular to the longitudinal direction, where the perineum damage-reducing device has an inner surface configured to be in contact with surfaces of the female human body and an outer surface opposite to said inner surface, where a thickness direction of said perineum damage-reducing extends from the inner surface to the outer surface, perpendicular to the width direction and the longitudinal direction; and where the attachment element is provided on the second part on the inner surface. The invention further relates to a method for reducing perineum damage during vaginal child delivery, using such a device.

[0005] Background Art

[0006] Damage to the perineum, i.e. the area between the opening of the vagina and the anus, is a common complication in vaginal child delivery and can cause long-term discomfort. Damage to the perineum may come in the form of perineal tears, which are laceration of the skin and other soft tissue structures which, in women, separate the vagina from the anus. Ruptures often start at the posterior part of the introitus vagina, i.e. the area of the introitus vagina closest to the anus and to the back of the body. While all ruptures give discomfort, more severe ruptures involving the anal sphincters or urethral sphincters may cause incontinence.

[0007] Up to 9 in 10 first-time mothers who have a vaginal child delivery will have some sort of perineum damage, making it the most common form of obstetric injury. Even though a sphincter injury is detected and sutured immediately after delivery, up to 50% of patients experience faecal or urinary incontinence, pain, or sexual dysfunction at some point. These complications can have important consequences for the woman's quality of life.

[0008] Perineal protection during vaginal child delivery can be achieved manually by healthcare personnel, usually midwives, placing their thumb and index finger on the perineum on opposite sides of the introitus vagina, also referred to as the vaginal opening, to support the perineum. However, many of them have not received proper training, especially not in developing countries.

[0009] To address the challenges associated with manual perineal support and reduce the need for trained healthcare personnel, attempts have been made to develop perineum damage-reducing devices.

[0010] One such device is described in W009101186A1. While to some degree effective in protecting the tissue in the posterior part of the introitus vagina, this device presents several significant drawbacks. It requires the involvement of trained healthcare personnel, limiting its widespread applicability and accessibility, and healthcare personnel report that the device is subject to spontaneous, unintended expulsion from the vagina during childbirth due to the contact between the device and the child. Expulsion of the device poses a risk to the device's efficacy in that it compromises a continuous perineal protection.

[0011] An improved perineum damage-reducing device, where the risk of expulsion is reduced, is known from WO2024146674A1. Experiments have, however, shown that the device is not always placed correctly inside the vagina, even when used by trained healthcare personnel, and that a risk of expulsion still exists. Furthermore, an even more efficient protection against perineum damage is desired. Summary

[0012] With this background, it is therefore an object of the invention to provide a perineum damage-reducing device which is further improved with respect to secure placement and sustained protection during vaginal child delivery process. Another object of the invention is to provide an improved method for reducing perineum damage during vaginal child delivery.

[0013] According to an aspect of the invention, this and further objects are achieved with a perineum damage-reducing device as described in the introduction, where the first part is longer than the second part in the longitudinal direction, and where the primary reinforcing element extends along a centre axis of the first part, said centre axis being parallel with the longitudinal direction and centred on the first part in the width direction.

[0014] The perineum damage-reducing device provides a protective effect via dispersion of the perineal tension over a wide surface area, not only over the area of the female body to which the second part is attached, but also to the vaginal wall via the first part. Moreover, the device may slow down the expansion time of the perineum, thus minimizing the risk of ruptures.

[0015] Even though the device is named a perineum damage-reducing device, it is to be understood that it may also reduce the likelihood of damage to the vaginal wall and that loads affecting the vaginal wall or introitus vagina may also contribute to an overstretching of the perineum.

[0016] The combination of the first part and the second part facilitates handling of the perineum damage-reducing device, as it ensures that the device is positioned correctly and remains in place during use. Only the second part needs to be attached to the female body directly, whereas the first part may be kept in place simply by having appropriate dimensions and / or shape. Example of such dimensions and shapes are provided below, and based on these further suitable dimensions and shapes can be determined by experiments without undue burden.

[0017] In other words, the second part is adapted to maintain the device in place during childbirth through adhesion and / or absorption of forces, while at least a section of the second part adheres to the skin and may be the only part of the device that is attached to the female body. The first part is configured for providing a protective barrier to the vaginal wall and / or facilitate vaginal child delivery, and the primary reinforcing element distributes forces over the length of the first part.

[0018] By the first part being longer than the second part of the device, stability and proper positioning of the device during a period of high stress to the perineum may be ensured. An advantage is that the first part may reach further into the vagina along the vaginal wall, thereby increasing the contact area between the device and the vaginal wall and / or between the device and the child's head. A large contact area between the device and the vaginal wall allows force to be distributed over a larger area of the vaginal wall and may imply that a larger area of the vaginal tissue is protected from damage, as the first part may provide a protective layer to the tissue it covers. Further, a longer first part may reduce the risk of the device collapsing and / or being displaced, since the force that the child's head exerts on the first part may occur with a distance to a distal end of the first part, i.e., the end which is furthest from the second part. It may be acceptable that the first part of the device travels with the child when contact between the first part and the child's head has been established, i.e., resulting in an acceptable or intentional partial or complete expulsion of the first part. Ones in contact with the child, the first part will provide support even though travelling with the child towards the introitus vagina and hence distribute force in the area, which is subject to the highest loads at any particular time.

[0019] The vaginal wall is here understood as the surface defining the vaginal tube formed by the vagina and that the wordings introitus vagina and vaginal opening are used interchangeably throughout this application.

[0020] In a state of delivery, the device may be in a flat condition. State of delivery refers to the state of the device at the time the user comes in possession of the device. In a state of use, the device will be in a non-flat condition, also referred to as a bend condition or state, where the first part and the second part extend at an angle relative to each other. It will be understood that the longitudinal direction is in relation to the flat condition of the device, i.e. when the inner and outer surfaces of the device are planar.

[0021] During vaginal child delivery, introitus vagina expands causing the adjacent areas, such as the perineum, to expand as well, and, consequently, due to the attachment of the second part to the perineum, at least a section of the second part may expand or otherwise change shape. This means that the perineum damage-reducing device may respond to changes in the shape of the female body during child delivery, while still providing a resistance to expansion, which reduced the risk of overstretching of the perineum. In addition to relieving the tissue of the perineum, an expansion or change of shape of the second part may help the first part to remain in contact with the vaginal tube even though not attached to it.

[0022] It will be understood that when reference is made to support of the perineum by the device throughout this description, said support may comprise providing a protective layer to the tissue of the female body, absorption of forces that occurs at the child passes through introitus vagina, and / or reduction of the speed / acceleration of the stretching of the perineum during vaginal childbirth. The perineum damage-reducing device is especially configured to redirect and absorb the energy of impact from the head and shoulders of the new-born during vaginal child delivery.

[0023] The contact area between the device and the tissue of the female body and / or the child refers to the area of the device that is in contact with the tissue when in use. This is not to be understood as if the area of the device needs to be in contact with the tissue at all times. Some sections may come into and out of contact with the tissue during different stages of vaginal child delivery as a consequence of deformation of either the tissue or the device or both. This particularly applies to the first part, which is not attached to the tissue, whereas some sections of the second part should preferably stay in contact with the tissue at all times.

[0024] Collapsing of the first part and / or second parts refers to unintentional bending of at least section of the first part and / or breaking of the first and / or second part. It is to be understood that the first part may be bent when inserted into the introitus vagina. Some deformation of the first part may be acceptable and may create a fold on the first part at the posterior part of the introitus vagina. The size of the perineum varies from individual to individual due to biological variation. Therefore, it may be an advantage to provide a first part that is rather too long than too short. In cases where the first part is too long, a bending of the first part may result in the device being usable without having to shorten the first part, for example by cutting.

[0025] The primary reinforcing element extending along a centre axis of the first part contributes to preventing a collapsing of the first and hence also contributes to preventing unintentional expulsion of the first part from the vagina. Furthermore, the primary reinforcing element provides stiffness to the first part along the centre axis, where the device is typically subject to the highest loads. This allows the loads to be distributed over the length of the first part, which will not only result in the local loads at the centre being reduced but also in an improved distribution of force to the sides of the first part, hence allowing loads to distributed over a large area, potentially even over the entire first part. Loads are thus distributed over a relatively large section of the vaginal wall instead of being concentrated at the introitus vagina and the perineum. In comparison, the shorter reinforcing elements provided at the sides of the first part in WO2024146674A1 distributes forces to the areas on each side of the introitus vagina and to the second part of the device, which is attached to the perineum. Common to all of the prior art devices is that the first part functions primarily as a slide, allowing the child to slide more easily through the last part of the vaginal tube and the introitus vagina, not to distribute forces on the vaginal wall.

[0026] In one embodiment, the primary reinforcing element has a width in the width direction, which is less than 50% of the smallest width of the first part in the width direction, preferably less than 30%, more preferred less than 20%. Side sections of the first part without reinforcement are then extending on opposite sides of the reinforcing element between the reinforcing element and side edges of the first part extending from the second part towards a distal end of the first part, said distal end being furthest from the second part. The centre axis will be located at approximately equal distance from both side edges.

[0027] When the width of the primary reinforcing element is less the width of first part and the primary reinforcing element is thus at a distance from the side edges, the primary reinforcing element will distribute force along the longitudinal direction, but still distribute some force in the width direction to the side sections, thus distributing force over the entire area of the vaginal wall, which is in contact with the first part. The distribution will depend on the stiffness of the reinforcing element relative to the stiffness of the side sections, but most of the load applied to the first part by the contact with the child will typically be transferred to the posterior part of the vaginal tube, i.e., the part of the vaginal tube closes to the back of the female human body near the perineal muscle zone, thus reducing horizontal expansion of the perineum. The terms "vertical" and "horizontal" are used herein to indicate directions when the device is in use while the female giving birth is lying on her back. It is to be understood that these direction will be different if the device is used in other birthing situations and are therefore not to be understood as limiting. As an example, the female may stand up and / or move around during child delivery. Due to the attachment of the second part to the female body and the first part extending far into the vaginal tube, the likelihood of the device falling out or becoming displaced when the female stands up and / or moves around is low. The relatively long first part may also contribute to keeping the device in place in such situations, as the first part will be located between the vaginal wall and the child's head and pressed against the vaginal wall by child's head.

[0028] In some embodiments the primary reinforcing element is of a linear shape, having substantially the same width over its entire length in the longitudinal direction. The primary reinforcing element may, however, also have different geometries with varying width, such as an hour-glass shape, a lens shape, or a tapering shape, or comprise two or more branches, for example two branches branching off from each other at a proximal end of the first part, closest to the second part, and meeting each other at the distal end, thus forming on open oval or lens shape. The primary reinforcing element may also have a T-shape with its head at the distal end of first part. The open oval or lens shape and the T-shape may contribute to preventing unintentional folding of the first part and / or may urge the first part towards the vaginal walls in the width direction, which may be particularly advantageous if the first part is relatively wide.

[0029] It is presently considered advantageous that the primary reinforcing element or a part of the primary reinforcing element extending in the first part has a width of 4-20 mm in the width direction, preferably 5-15 mm, more preferably 6-10 mm.

[0030] The first part preferably has a width of 30-90 mm in the width direction, preferably 40-70 mm, more preferably 45-60 mm. In other embodiments, the first part has a width of 30 to 400 mm, preferably 125 to 350 mm, more preferably 200 to 300 mm.

[0031] When the primary reinforcing element extends only in the first part, it is presently considered advantageous that the reinforcing element has a length of 50-110 mm in the longitudinal direction, preferably 60-100 mm, more preferably 70-80 mm.

[0032] In an embodiment, the first part has a length of at least 65 mm in the longitudinal direction, preferably at least 80 mm, preferably at least 90 mm, preferably at least 100 mm, preferably at least 110 mm, preferably at least 120 mm, more preferably at least 130 mm. By providing a first part with a length of at least 65 mm, the first part may extend all the way to the cervix of the female body. These dimensions have been found to match the anatomy of the average female body of Western European women. However, natural variation should be taken into account.

[0033] The perineum damage-reducing device can be made from any material which is bendable so that it can be arranged with a bend between the first part and the second part, so that when the device is in use the first part is able to extend from the second part arranged on the perineum, over the posterior part of the introitus vagina and into the vagina. The bend allows the first part to extend from the perineum, over the posterior part of the introitus vagina to the body section inside the vagina. Adaptability, with an angle preferably in the range of 20-70 degrees, preferably 30-60 degrees, preferably 30-40 degrees, caters to changes in the shape of the female body during childbirth.

[0034] The bendable nature of the device may facilitate correct positioning along the vaginal wall at the posterior part of the introitus vagina, in that the birth helpers only needs to ensure that the second part is attached properly and then insert the first part in the vagina. This is advantageous as it may be difficult to see the first part once inserted, and thus difficult to know if it is positioned correctly. This entails that the device can be applied by less skilled or unskilled birth helpers, such as birth helpers in developing countries, who have often received no or only very basic training. It may also be useful for trained birth helpers, such as health workers, midwives, and doctors.

[0035] To further facilitate correct application, the primary reinforcing element may extend into the second part and / or a secondary reinforcing element is provided in the second part, preferably extending in continuation of the primary reinforcing element in the first part. Providing one or more reinforcing elements in the second part may contribute to ensuring desired properties of the second part allowing it to prevent overstretching of the perineum, and may also facilitate handling and hence correct application of the device. If the primary reinforcing element extends into the second part, it must be configured for allowing bending of the device, for example by being made from a plastic, i.e., substantially non-elastic material, or the device may be provided in a pre-bend state.

[0036] In one embodiment, the primary reinforcing element has a flat end surface at a proximal end or at the joint between the first part and the second part, such as in a neck section of the first part, said flat end surface extending in the width direction and in thickness direction, preferably perpendicular to the longitudinal direction. This end surface may be used for applying force on the device in the longitudinal direction in order to push the first part into the vagina, either during insertion of the device or to prevent unintentional expulsion.

[0037] The primary reinforcing element and the second reinforcing element if any is preferably without sharp edges to avoid damage to the device, the female and the child.

[0038] In one embodiment, the at least one reinforcing element is elastic, pulling the device towards the state of delivery. This may contribute to the ability of the device to follow changes in the shape of the female body during child delivery, such as the introitus vagina expanding during passing of the child. Elasticity of the reinforcing element also reduces the risk of breakage, which might result in the formation of sharp edges.

[0039] The reinforcing element may be made from the same material as the rest of the device and may then be constituted by a thickening of the material. The material from which the device is made is here to be understood as the material forming the first part and the second part, not including the attachment element and other items, such as a liner provided to protect the attachment element before use.

[0040] Alternatively, or additionally, the reinforcing element may be embedded in or attached to a sheet of flexible material, for example being arranged between two sheets of flexible material defining the inner surface and the outer surface, respectively. In the case of the reinforcing element is made from the same material as the sheet(s), the material of the reinforcing element may have a higher density or compactness. The reinforcing element has a higher stiffness than the sheet. This enables the reinforcing element to reinforce the device and thereby facilitate handling of the device. The stiffness refers to the extent to which an object resists deformation in response to an applied force. The stiffness ensures a stable reinforcing element.

[0041] The reinforcing elements may comprise a polymeric material, such as elastomers, thermoplastic elastomers, mediprene thermoplastic elastomers, nylon, polypropylene, polyethylene, polyurethane, polycarbonate, vinyl, polytetrafluoreten, silicon, or textiles. In an embodiment, the reinforcing elements may comprise a non-polymeric material, such as a metallic material. If the reinforcing element is not covered by the sheet element, it should preferably be biocompatible.

[0042] As mentioned above, a sheet of material may form part of the device, possibly defining the inner and / or outer surface. In the context of this patent application, a "sheet of flexible material" refers to a planar structure composed of a pliable substance that can bend, deform, or adapt to different shapes. The term encompasses entities that are (geometrically) thin, substantially flat, and (mechanical) can be easily manipulated or moulded. Examples of materials fitting this description include but are not limited to polymers, elastomers, fabrics, films, membranes, or any other analogous flexible materials. The use of the term "sheet" does not necessarily imply a strict two-dimensional limitation, and may also encompass materials with some degree of thickness. The thickness may be variable and continuous. Synonyms for "sheet" in this context could include layer, membrane, film, panel, plate, board, plank, or any other term conveying a planar structure.

[0043] Flexible materials refer to materials having the ability to bend or compress easily without cracking under normal conditions. Flexible materials enable the device to fit different shapes which is advantageous in a dynamic environment, such as during a vaginal child delivery. In a preferred embodiment, the sheet of flexible material comprises a polymeric material, such as elastomers, thermoplastic elastomers, mediprene thermo-plastic elastomers, nylon, polypropylene, polyethylene, polyurethane, polycarbonate, vinyl, poly- tetrafluoreten, silicon, or textiles.

[0044] In one embodiment, the sheet of flexible material may comprise a non-polymeric material.

[0045] The sheet of flexible material may comprise one or more layers of the same material or different materials.

[0046] In one embodiment, the sheet of flexible material comprises a transparent material. The transparent material may allow the user to continuously inspect the tissue underneath, during application of the device and / or during child delivery. A reinforcing element may also be made from a transparent material.

[0047] The sheet of flexible material and / or the primary reinforcing element and / the secondary reinforcing element may have perforations or grooves. This helps potential fluids, such as bodily fluids to be removed from the area. This may be especially advantageous in the sheet, as fluids may compromise adhesion. This feature also protects the skin from any potential damage as prolonged exposure to liquids may damage the skin. Perforations may also enable the unskilled birth helper to inspect the skin through the perforations, which is useful in cases where the material is non-transparent.

[0048] At least a section of the first part and at least a section of the second part may be made from the same material.

[0049] The material(s) and dimensions used should be configured to modulate the perineal stretch speed.

[0050] In one embodiment the first part comprises a neck section and a body section, wherein the neck section has a proximal end connected to the second part and a distal end connected to the body section, wherein the neck section constitutes a bending zone facilitating a bending of the perineum damage-reducing device about a primary bending axis, which is parallel to the width direction, and wherein the primary reinforcing element does not extend into the neck section.

[0051] By the primary reinforcing element extending only on the first part and not extending into the neck section, bending at the neck section is facilitated, thus contributing to ensuring the perineum damage-reducing device bends at the intended position and thereby facilitating correct application of the device.

[0052] The neck section may be narrower than the body section in the width direction to facilitate bending. In that case the width of the first section is measured at the neck section when determining a relative width of the primary reinforcing element.

[0053] By providing a more narrow neck section, the device may comply with the anatomy of the female human body without using excess material. Further, an advantage may be that the neck section is positioned at the introitus vagina where there may be less space than inside the vaginal tube where the body section is positioned. This may facilitate handling of the device, and may facilitate correct positioning and stability of the device during use, whereas the wider and / or larger body section provides for a large contact area between the device and the tissue of the female body and / or between the device and the child's head. The neck section of the first part is configured to interact with critical areas like the anterior perineum, posterior vestibule, and vaginal tube. It may reduce the expansion of the perineum horizontally by distributing force downwards and / or distributing the forces in different directions than those directly applied by the child's head. Furthermore, the neck section may serve as a force distribution layer evening out possible difference in deformation of the tissue of the vaginal tube, the posterior vestibule, and the anterior perineum, and serving as a slide guiding the child's head over and through the in- troitus vagina. The neck section may thus offer protection against internal ruptures or tears by supporting critical areas. This will apply, even if the neck section has substantially the same width as the body section, i.e. to any first part regardless of shape.

[0054] The body section and / or the neck section of the first part may facilitate insertion or removal of the device, potentially shielding internal structures and adapting to internal contours for enhanced fit and comfort.

[0055] In an embodiment, the neck section has a length of 30 mm to 110 mm, preferably 50 mm to 100 mm, more preferably 65 mm to 90 mm. The length of the neck section may be advantageous to match the dimensions of the female body, such as perineum.

[0056] In an embodiment, the width of the neck section is 10 to 100 mm, preferably 20 mm to 75 mm, preferably 25 to 60 mm, more preferred 35 to 50 mm.

[0057] To further facilitate correct application of the perineum damage-reducing device, one or more tertiary reinforcing elements may be provided in the neck section, providing resistance against bending about a secondary bending axis, which is parallel to the longitudinal direction. A tertiary reinforcing element may for example be a thickening of a sheet material forming the neck section. In an embodiment, at least three such thickenings each extend over the entire width of the neck section.

[0058] In an embodiment, the first part or a body section of the first part comprises at least two arms, preferably four arms, extending outwardly at an angle to the longitudinal direction, such as radially from a / the centre section, preferably symmetrically about the longitudinal direction.

[0059] By providing at least two arms, the contact area between the device and the child and / or the female body is increased, and the stability of the device may be increased. An advantage is that the risk of the device collapsing is decreased, as the device and / or the first part may still work even if at least one of the arms has collapsed or folded.

[0060] In an embodiment, the at least two arms diverge away from the centre section of the body section to comply with the anatomy of the female body and thereby potentially ensure max surface contact. In an embodiment, the body section comprises at least two arms, each extending outwardly in the width direction substantially with an angle of 90 degrees relative to the longitudinal direction.

[0061] In an embodiment, the at least two arms substantially have the same length.

[0062] In an embodiment where the body section comprises four arms, each arm extends at an angle relative to both the longitudinal direction and the width direction, preferably two arms extending in a forward direction towards the distal end of the first part and two arms extending in a backward direction towards the proximal end of the first part or in a sideward direction, substantially perpendicular to the longitudinal direction. With four arms, the body section will have a flower shape. The shape of the arms enables to first part to spread out further in the vagina in multiple directions. Embodiments with three of five arms are also possible and one arm will then extend in the longitudinal direction, forming the distal end of the first part.

[0063] The primary reinforcing element may be shaped to extend into the arms, having for example a four-leaf clover shape if there are four arms.

[0064] In an embodiment, the first part comprises an anchor, preferably at the distal end of the first part. The anchor may be in the formed by bending the first part or by a protrusion extending in the thickness direction of the first part. The anchor may be flexible. The anchor of the first part may allow the first part to obtain a stable position within the vaginal cavity as the anchor may provide for a point of fixation and / or contribute to vertical hold and retainment of the first part.

[0065] In an embodiment, the anchor is in the form of a frictional element provided on the inner surface of the first part of the device.

[0066] The second part preferably extends further in the width direction than the first part to be able to cover and attach to a large area of the perineum and distribute forces, but in embodiments where the first part comprises arms as described above, the arms may extend so far in the width direction that the total width of the first part equals the width of the second part.

[0067] The size of the perineum damage-reducing device may be adaptable to different anatomical sizes, for example by being made from a material / materials, which are cutable, allowing it to be cut to size. This is useful for example in cases where the area between the posterior part of the introitus vagina and anus is smaller than average and where the size of the second part may then be reduced. Another advantage of using cutable material for the second part is that an epsiotomi may be performed without removing the device. Likewise, the first part may be cutable to allow adaptation of its size and / or shape. Reinforcing elements may be cutable or provided at a distance from the edges of the device, allowing sections to be removed without affecting the reinforcing element(s).

[0068] In an embodiment, the first part has a thickness smaller than a thickness of at least a section of the second part. As the second part may ensure stability of the device, at least a section of the second part preferably has a thickness in the range of 0.1 mm to 10 mm, preferably 0.5 mm to 5 mm, preferably 1 mm to 4 mm, more preferably 1 mm to 3 mm to ensure stability of the device, such that it does not break during use. By providing the first part with a relatively small thickness, it may be possible to cover a larger contact area between the first part and the child and / or female body without taking up unnecessary space. The smaller thickness of the first part relative to the second part may apply only to sections of the first part not including the primary reinforcing element.

[0069] In an embodiment, the first part of the device has a thickness of 0.1 mm to 7 mm, more preferably 0.5 mm to 3 mm.

[0070] In an embodiment, at least a section not carrying an attachment element, such as the centre section and / or the flexible section, of the second part of the device has a thickness of 0.1 mm to 5 mm, more preferably 0.5 mm to 2 mm.

[0071] In one embodiment, the attachment element comprises an adhesive, preferably a 3- layer chemical adhesive. This may help the second part of the device to remain in place during use.

[0072] The attachment element may be provided on the flexible material forming at least part of the second part or be integrated in at least part of the second part. The attachment element at the inner surface of the second part may be provided in that the inner surface of the second part is in itself adhering or in that an attachment element is provided on the inner surface. The attachment element is made of a material that adheres to surfaces of the female body, and preferably a material that adheres to surfaces of the body, which are covered with bodily fluids, such as vaginal secretion.

[0073] In one embodiment, only the inner surface of the second part comprises an attachment element. The outer surface of the first part may be smooth with a low frictional resistance against human skin and hair, at least when wet. This may help the child slide over the device.

[0074] The flexible material of the device should be biocompatible and should not cause an allergic reaction. For this reason, latex or similar allergenic materials may be less preferred.

[0075] A separate attachment element may comprise an adhesive, such as a pressure-sensitive adhesive or glue, e.g. tissue specific glue. It may be advantageous that the attachment element is able to adhere to places where hair appears to ensure good adhesion.

[0076] The attachment element may be covered by a cover in a state of delivery. This may prevent the device from unintentionally attaching to other items, such as other perineum damage-reducing devices. The cover may comprise several separate elements or be divided in two or more sections, for example by perforations, such that sections of the attachment element may be uncovered independently. This will, for example, allow the middle section of a second part, that comprises a middle section and two side section to be uncovered and attached to the female body, while the side section remain covered. This will allow the application of the device, while some part of the attachment element remain covered, thus reducing the risk of unintentional attachment. Once the device has been positioned and attached at the middle section, the cover on the side sections can be removed and the side sections attached to the female body. Other application sequences are also possible.

[0077] In an embodiment, the second part of the device further comprises a peeling tap, preferably two peeling taps, more preferred four pealing taps to enable the device to be removed quickly in an emergency situation.

[0078] In an embodiment, the second part comprises a flexible section configured for being deformed and / or stretched during vaginal child delivery, and at least one stiff section configured for substantially maintaining its shape. By providing a flexible section, the device may deform and / or stretch during use to support the perineum. The stiff section may provide stability to the device and ensure that the device does not break or detach from the female body.

[0079] In an embodiment, the stiff section of the second part is adapted to maintain the device in place during childbirth. The references to a stiff section and flexible section is not to be understood as if the stiff section needs to be inflexible, rather it is to be understood that the stiff section is less flexible than the flexible section.

[0080] The stiff section may achieve its stiffness through a thickness of the at least one stiff section. In such embodiments, the thickness of the at least one stiff section is greater than a thickness of the flexible section.

[0081] Alternatively or additionally, the stiff section may comprise a reinforcing material for achieving stability and / or stiffness of the stiff section.

[0082] In an embodiment, the stiff section of the section part has a thickness of 1 mm to 10 mm, preferably 1 mm to 4 mm, more preferably 1mm to 3 mm.

[0083] In an embodiment, the at least one stiff section comprises the attachment element, preferably an adhesive. The stiff section may ensure that the second part and / or the device is held in position during use by adhering to the skin. By providing the attachment element in the stiff section, improved adhesion to the skin may be achieved through stability of the stiff section, such that deformation of the second part does not occur at an attachment area. The flexible section may not comprise an attachment element and may comprise a smooth surface to reduce friction against the female body, such the flexible section may easily deform and thereby reduce forces on the adhered section(s). This may help to ensure that adhesion to the female body during use is not compromised.

[0084] In an embodiment, the second part comprises at least one secondary reinforcing element for improving the stability of the device, said reinforcing element either forming part of the stiff section or supplementing it. Additionally, or alternatively, the primary reinforcing element may extend into the second part.

[0085] In an embodiment, the second part comprises at least two legs, preferably four legs, extending outwardly at an angle to the longitudinal direction, such as radially from a centre section of the second part, preferably symmetrically about the longitudinal direction.

[0086] Dampening speed of horizontal stretch is achieved through the viscoelastic property of the material of at least the second part. The at least two legs may extend along each side of the anus contribute to perineal support, preventing ruptures.

[0087] The at least two legs may extend along the perineum to provide perineal support, dampening and reducing the speed of the stretching during contractions. In an embodiment, at least one of the at least two legs comprises the attachment element. This may facilitate attachment and / or handling of the device.

[0088] In an embodiment, at least one of the at least two legs constitutes at least a part of the stiff section of the second part.

[0089] In an embodiment, the legs of the second part hart a higher stiffness than the first part of the device. This may facilitate handling of the device. The stiffness refers to the extent to which an object resists deformation in response to an applied force. The stiffness may ensure that at least part of the second part is stable.

[0090] In an embodiment, a vertical hold provided by the at least two legs, may constrain the stretching of the perineum to a maximum of 5-10 cm.

[0091] The legs of the second part and / or the arms of the first part may substantially have the same length.

[0092] In an embodiment, the second part has a length in the range of 35 mm to 70 mm, preferably 45 to 65 mm.

[0093] In an embodiment, edges of the legs of the second part and / or the arms of the first part are substantially rounded.

[0094] The thickness of the first part and / or of the second part may vary. For example, the second part may be thicker or thinner in a centre section of the legs compared to edges of the legs to provide desired physical properties and / or or the edges of the second part may be thinner than the rest to facilitate attachment or removal to facilitate attachment. This may further provide improved stability of the device as the risk of unintended removal of the device may be reduced. Moreover, thinner edges may result in a rounded shape of the legs, reducing the risk of the legs being unintentionally peeled off, for example due to being caught and carried along by other items used during vaginal child delivery or the birth helper's hands. As another example the edges of the first part may be thinner than a central section to make them more pliable than the central section, thereby potentially facilitating insertion or giving the first part a shape matching the shape of the vaginal wall.

[0095] The thicknesses of the first part and the second part may provide a balance between material consumption, ease of handling, and functionality, and to increase the contact area. The thickness of the device may be selected based on functionality and the acceptance by the user, i.e. the device may from a technical perspective work at thicknesses down to 0.1 mm, but may be thicker to accommodate the user's perception and acceptance of it.

[0096] In an embodiment, at least part of the centre section of the second part constitutes the flexible section.

[0097] In an embodiment, the at least two legs of the second part have a thickness greater than a thickness of the flexible section of the second part for providing stiffness and / or improved adhesion.

[0098] In an embodiment, the at least two legs extends away from the second part along the perineum in approximately opposite directions, more specifically approximately along the surface of the perineum covering a transverse perineal muscle, so as to provide perineal support.

[0099] In an embodiment, the at least two legs extend away from the centre section of the second part along the perineum in approximately opposite directions, each extending towards each of the lateral perineum borders (medial surface of thigh).

[0100] In an embodiment, at least two legs extend away from the centre section of the second part along the perineum on each side of the anus so as to provide perineal support.

[0101] In an embodiment, two legs extends away from the centre section of the second part along the perineum on each side of the anus towards inferior border of the perineum (intergluteal cleft).

[0102] In an embodiment, the inner surface of said first part comprises a smooth surface. A smooth surface comprises a non-adhering surface. The smooth surface may facilitate handling of the device, as the first part will not stick to undesired places. This is particularly useful in cases where the first part is initially placed incorrectly, which may happen frequently especially for unskilled birth helpers, as the first part may not be visible due to its position inside the vagina. When the second part has been attached to the surfaces of the female body, the first part will consequently be free to reposition itself and fall into place as described above.

[0103] The smooth surface may still provide friction between the device and the female body and / or the child.

[0104] The first part of the device is held in place primarily due to its shape and / or dimensions. A smooth surface of the first part may be an advantage in that it allows the first part to move when having achieved a relatively large contact area with the child's head while avoiding unnecessary friction between the device and the female body and / or the device and the child's head.

[0105] In an embodiment, the device comprises a viscoelastic polymer.

[0106] The support function of the device is instrumental in mitigating the impact forces exerted during contractions and / or fatal pressure and / or changes of ligaments and / or maternal pushing, thus safeguarding the perineum from potential ruptures. The device may achieve this through the utilization of its viscoelastic polymeric properties which possesses a high loss modulus (high dampening factor and / or tan delta - the ratio of loss modulus / elasticity modulus). This unique property allows the device to effectively absorb and dissipate the forces generated by contractions, facilitating a controlled and gradual expansion of the perineum. The inclusion of legs that extends across the perineum further enhances this function, working in harmony with the adhesion mechanism.

[0107] Flexible materials refer to materials having the ability to bend or compress easily without cracking under normal conditions. Flexible materials enable the device to fit different shapes which is advantageous in a dynamic environment, such as during a vaginal child delivery.

[0108] In an embodiment, the device is made of a sheet of flexible material, which may comprise one or more layers of the same material or different materials.

[0109] In one embodiment, the flexible material comprises a transparent material. The transparent material may allow the user to continuously inspect the tissue underneath, during application of the device and / or during child delivery. The sheet of flexible material may have perforations or grooves. This helps potential fluids, such as bodily fluids to be removed from the area. This may be an advantage as fluids may compromise adhesion. This feature also protects the skin from any potential damage as prolonged exposure to liquids may damage the skin. Perforations may also enable the unskilled birth helper to inspect the skin through the perforations, which is useful in cases where the sheet is non-transparent.

[0110] In an embodiment, the flexible material may be able to expand to double or triple its size.

[0111] In an embodiment, the flexible material is elastic. Elastic refers to the elasticity of a material, which is the tendency of solid materials to return to their original shape after forces are applied on them. This is an advantage when the introitus vagina expands and causes the adjacent surfaces to expand as well. When expanded, the sheet will thereby seek to return to its original shape and may thereby resist expansion of the perineum.

[0112] In an embodiment, the perineum damage-reducing device comprises a safety removal functionality, allowing for quick removal in emergency situations, achieved by peeling tabs on the legs of the second part, where the peeling is directed inwards to prevent skin damage.

[0113] In an embodiment, the device is at least partly cast moulded and / or injection moulded. In an embodiment the second part and / or the neck section and / or the body section of the first part is least partly cast moulded and / or injection moulded.

[0114] Sections of the device on opposite sides relative to the longitudinal direction and at the joint between the first part and the second part may be referred to as the shoulders. The shoulders may be subject to relatively high loads and should be provided with sufficient tear resistance to avoid ruptures. At the same time, the shoulders should preferably be thin and smooth to not take up unnecessary space at the vaginal opening and be able to bend to facilitate application of the device. The shoulders may form part of the flexible section of the second part.

[0115] In an embodiment, the device is a single-use device.

[0116] A second aspect of the present disclosure relates to a method for reducing perineum damage to a female human body comprising vagina, introitus vagina, perineum, and anus during vaginal child delivery, comprising: a) providing a perineum damage-reducing device according to any one of the preceding claims, b) inserting the first part of the perineum damage-reducing device into the female human body via introitus vagina at a posterior part of introitus vagina, so that the primary reinforcing element extends into the vagina in a direction of insertion extending away from introitus vagina, c) arranging the second part of the perineum damage-reducing device to extend outside the female human body away from the posterior part of introitus vagina towards anus, and d) attaching the at least one attachment element to a surface of the female human body. The direction of insertion during step b) is substantially parallel to the longitudinal direction of the perineum damage-reducing device.

[0117] The longer first part makes it easier to insert the first section in such a manner that it becomes positioned between the vaginal wall and the child's head. Inserting the first part between a wall of the vagina and a head of a child during step a) will prevent the first part from moving away from the vaginal wall due to elasticity in a / the material from which the perineum damage-reducing device is made. Furthermore, it may increase the likely of correct positioning and contribute to preventing unintentional expulsion of the device.

[0118] It is noted that step c) can be performed before b) depending on the preference of the midwife or other birth helper and the specific design of the perineum damage-reducing device, such as the stiffness of the first part relative to the stiffness of the second part.

[0119] In an embodiment, the perineum damage-reducing device is bent about a primary bending axis, which is parallel to the width direction, during step a), during step b), or prior to both step a) and step b). The order of performance of steps b) and c) may also depend on when the device is being bent.

[0120] To facilitate insertion into the vagina, the method many comprise bending the first part about a secondary bending axis, which is parallel to the longitudinal direction, during step a) or prior to step a).

[0121] In an embodiment, the device may be applied during the second stage of labour. The second stage refers to the period of time from when the cervix is substantially fully dilated to when the child is born.

[0122] In an embodiment the first part is arranged in the vaginal tube when the child's head has passed symphysis pubis and the child's neck is opposite to the symphysis pubis. At this stage, the position of the child is relatively stable, and the birth helper has room for insertion of her / his hand holding the first part.

[0123] Embodiments and advantages described with reference to one aspect of the present disclosure also applies to the other unless otherwise stated. As an example, the possible removal of sections of a cover at different times during the application of a perineum damage-reducing device described above with reference to the first aspect also applies to the method. Brief Description of Drawings

[0124] In the following description, embodiments will be described with reference to the schematic drawings, in which

[0125] Fig. 1 is a front view of a perineum damage-reducing device according to an embodiment;

[0126] Fig. 2 is a front view showing external female genital organs during vaginal child delivery, and a perineum damage-reducing device during use;

[0127] Fig. 3 is a cross-sectional view of a female body and a perineum damage reducing device in use during vaginal child delivery;

[0128] Fig. 4 is a front view of a perineum damage-reducing device according to an embodiment;

[0129] Fig. 5 is a front view showing external female genital organs during vaginal child delivery, and a perineum damage-reducing device during use;

[0130] Fig. 6 is a cross-sectional view of a female body and a perineum damage-reducing device in use during vaginal child delivery;

[0131] Fig. 7 is a front view of a perineum damage-reducing device according to an embodiment;

[0132] Fig. 8 is a perspective view of a perineum damage-reducing device according to an embodiment;

[0133] Fig. 9 is a perspective view of a perineum damage-reducing device according to an embodiment;

[0134] Fig. 10 is a cross-sectional view of a female body and a perineum damage-reducing device in use during vaginal child delivery;

[0135] Fig. 11 is a front view of a perineum damage-reducing device according to an embodiment;

[0136] Fig. 12 is a cross-sectional view of a female body and a perineum damage-reducing device in use during vaginal child delivery;

[0137] Fig. 13 is a front view of a perineum damage-reducing device according to an embodiment;

[0138] Fig. 14 is a front view showing external female genital organs during vaginal child delivery, and a perineum damage-reducing device during use; Fig. 15 is a cross-sectional view of a female body and a perineum damage reducing device in use during vaginal child delivery;

[0139] Fig. 16 is a front view of a perineum damage-reducing device according to an embodiment;

[0140] Fig. 17 is a front view showing external female genital organs during vaginal child delivery, and a perineum damage-reducing device during use;

[0141] Fig. 18 is a cross-sectional view of a female body and a perineum damage reducing device in use during vaginal child delivery;

[0142] Fig. 19 is a front view of a perineum damage-reducing device according to an embodiment;

[0143] Fig. 20 is a front view showing external female genital organs during vaginal child delivery, and a perineum damage-reducing device during use;

[0144] Fig. 21 is a cross-sectional view of a female body and a perineum damage-reducing device in use during vaginal child delivery;

[0145] Fig. 22 is a front view of a perineum damage-reducing device according to an embodiment;

[0146] Fig. 23 is a front view showing external female genital organs during vaginal child delivery, and a perineum damage-reducing device during use;

[0147] Fig. 24 is a cross-sectional view of a female body and a perineum damage-reducing device in use during vaginal child delivery;

[0148] Fig. 25 is a front view of a perineum damage-reducing device according to an embodiment;

[0149] Fig. 26 is a front view of a perineum damage-reducing device according to an embodiment;

[0150] Fig. 27 is a perspective view of a perineum damage-reducing device according to an embodiment;

[0151] Fig. 28 is a front view of a perineum damage-reducing device according to an embodiment;

[0152] Fig. 29 is a front view showing external female genital organs during vaginal child delivery, and a perineum damage-reducing device during use;

[0153] Fig. 30 is a cross-sectional view of a female body and a perineum damage reducing device in use during vaginal child delivery; Fig. 31 is a front view of a perineum damage-reducing device according to an embodiment;

[0154] Fig. 32 is a front view showing external female genital organs during vaginal child delivery, and a perineum damage-reducing device during use;

[0155] Fig. 33 is a cross-sectional view of a female body and a perineum damage reducing device in use during vaginal child delivery;

[0156] Fig. 34 is a front view of a perineum damage-reducing device according to an embodiment;

[0157] Fig. 35 is a cross-sectional view of a female body and a perineum damage-reducing device in use during vaginal child delivery;

[0158] Fig. 36 is a perspective view of a perineum damage-reducing device according to an embodiment;

[0159] Fig. 37 is a front view of a perineum damage-reducing device according to an embodiment;

[0160] Fig. 38 is a front view of a perineum damage-reducing device according to an embodiment;

[0161] Fig. 39 is a perspective view of a section of a first part of a perineum damage-reducing device according to an embodiment;

[0162] Fig. 40 is a perspective view of a section of a first part of a perineum damage-reducing device according to an embodiment;

[0163] Fig. 41 is a perspective view of a section of a first part of a perineum damage-reducing device according to an embodiment;

[0164] Fig. 42 is a perspective view of a perineum damage-reducing device according to an embodiment;

[0165] Fig. 43 is a cross-sectional view of a perineum damage-reducing device according to an embodiment;

[0166] Fig. 44 is a cross-sectional view of a perineum damage-reducing device according to an embodiment.

[0167] Fig. 45 is a front view of a perineum damage-reducing device according to an embodiment;

[0168] Fig. 46 is a cross-sectional view of a perineum damage-reducing device according to an embodiment. Fig. 47 is a front view of a perineum damage-reducing device according to an embodiment;

[0169] Fig. 48 is a cross-sectional view of a perineum damage-reducing device according to an embodiment.

[0170] Fig. 49 is a front view of a perineum damage-reducing device according to an embodiment;

[0171] Fig. 50 is a cross-sectional view of a perineum damage-reducing device according to an embodiment.

[0172] Fig. 51 is a front view of a perineum damage-reducing device according to an embodiment;

[0173] Fig. 52 is a cross-sectional view of a perineum damage-reducing device according to an embodiment.

[0174] Fig. 53 is a front view of a perineum damage-reducing device according to an embodiment;

[0175] Fig. 54 is a cross-sectional view of a perineum damage-reducing device according to an embodiment.

[0176] Description of Embodiments

[0177] Referring initially to Fig. 45 and Fig. 46, an embodiment of a perineum damage-reducing device 1 for reducing damage during vaginal child delivery is shown. The perineum damage-reducing device comprises a first part 10 configured to be inserted into a female body via introitus vagina at a posterior part of introitus vagina, and a second part 20 configured to extend outside the female body away from the posterior part of introitus vagina towards anus as will be described in detail below with reference to Fig. 2 and Fig. 3.

[0178] In the flat condition shown in Fig. 45, the second part 20 extends in continuation of the first part 10 in a longitudinal direction L of the perineum damage-reducing device 1, an inner surface 32 extends over the first part 10 and the second part 20 and is configured to be in contact with surfaces of the female body, and an outer surface 33 is opposite to said inner surface 32. In Fig. 45, the outer surface 33 of the device faces the viewer. The first part 10 is longer than the second part 20 in the longitudinal direction. The first part 10 has a length of approximately 130 mm, and the second part 20 has a length of approximately 60 mm.

[0179] The perineum damage-reducing device has a width direction W perpendicular to the longitudinal direction L, and a thickness direction T perpendicular to the width direction W and the longitudinal direction L. The flat condition shown in Fig. 45 and 46 may be the state of delivery.

[0180] The first part 10 comprises a neck section 9 and a body section 13. The neck section 9 has a proximal end 91 connected to the second part 20 and a distal end 92 connected to the body section 13. The neck section 9 is narrower than the body section 13 in the width direction W. The width of the neck section is indicated by Wl, and the width of the body section is indicated W2. In this embodiment, the body section 13 is longer than the neck section 9. In other embodiments, the neck section 9 is longer than the body section 13 in the longitudinal direction L.

[0181] As seen in Figs. 45-54, the first part 10 further comprises a primary reinforcing element 41 extending along a centre axis C in the longitudinal direction at equal distance from both side edges 14a, 14b. The primary reinforcing element 41 may extend into the second part 20, as it is shown in the embodiment of Fig. 45, or extend only in the first part, for example until the distal end 92 of the neck section 9 as in Fig. 49. In the embodiments where the primary reinforcement 41 extends until the distal end 92, a secondary and / or a tertiary reinforcing element may be comprised in the second part 20 and the neck section 9, respectively, as will be described below.

[0182] In the embodiments of Figs. 45-46, 49-50 and 53-54 the primary reinforcing element 41 has a width of less than 50% of the total width of the first part, in Fig. 45 less than 20% of the total width. Side sections, which are less stiff than the primary reinforcing element, extend on either side between the primary reinforcing element and the side edges 14a. 14b. In the embodiment in Fig. 53, the side sections are of a configuration with sub-sections of different and varying thickness, thus providing a bigger and / or more refined load-distribution potential than for the embodiment in Fig. 45.

[0183] In the embodiment of Fig. 47-48 the width of the primary reinforcing element 41 is only slightly smaller than the total width of the first part and in the embodiment in Fig. 51-52 the primary reinforcing element has a width equal to the width of the first part of the device.

[0184] In Fig. 49-50 the perineum damage-reducing device 1 comprises the primary reinforcing element 41 along the first part 10, and a tertiary reinforcing element 43 in the neck section. Said tertiary reinforcing element 43 is formed by a series of ridges 431 extending perpendicularly to the centre axis, from one side edge of the neck section 9 to the opposite side edge of the neck section. The ridges are formed by a change in the thickness of the material in the neck section 9, allowing the neck section 9 to act as a hinge, by having stiff portions in the ridges formed by a greater material thickness, and flexible portions formed by a lower material thickness. The ridges are equidistant to each other and extend from the distal end 92 to the proximal end 91. The tertiary reinforcement prevents unintentional bending about an axis parallel to the longitudinal direction during insertion of the first part into the vagina, the direction of insertion being substantially parallel to the longitudinal direction.

[0185] A similar tertiary reinforcement 43 is seen in Fig. 51-52, where it covers a larger area of the first part.

[0186] Tertiary reinforcing elements are only as a plurality of elements and only in embodiments comprising a neck section, but it is to be understood that a single tertiary reinforcing element may suffice and that one or more tertiary reinforcing elements may be provided on a first element without a neck section. In that case the tertiary element(s) will be provide where the device bends during use.

[0187] The ridges, as seen in Fig. 50 and Fig. 52, are formed in a rectangular cross section. The ridges could have other shapes, but the flat end surface provide by the rectangular cross section when seen in the longitudinal direction is advantageous in that it provides a surface which can be pushed on when inserting the first part 10 into the female body or held against when there is a risk of unintentional expulsion of the first part.

[0188] A flat end surface 412 suitable for use in pushing on the first part is also found on the primary reinforcing element in Figs. 47-54, said flat end surface forming an angle, around 90 degrees with the neck section, where the thickness of the material is lower to allow for a flexible portion.

[0189] At the opposite end of the first part 10 in these embodiments, the primary reinforcing element 41 gradually decreases in material thickness to form a slope 411 at the distal end of the first part 10. The slope 411 allows for easier insertion of the first part 10 into the female body, specifically to facilitate the insertion of the first part 10 between the child's head 52 and the vaginal wall and / or allows the child to move over the distal end of the first part with less friction that when having a primary reinforcing element without a slope as in Figs. 45-46.

[0190] Figs. 49-50 shows a perineum damage-reducing device 1 further comprising a secondary reinforcing elements. The secondary reinforcing element 42 extends along the same centre axis as the primary reinforcing element 41, across the second part 20. Thicker and / or stiffer sections of the second part as those forming a butterfly-shape in Figs. 47 and 51 may also serve as secondary reinforcing elements.

[0191] As mentioned above, the reinforcing elements 41, 42, 43 may be formed by use of a stiff material embedded or attached to the material used for other parts of the device, or by increasing the thickness of one material used for the entire device.

[0192] In all of Figs. 45-54 as well as in Fig, 1, the second part 20 comprises four legs 22a-d, each extending outwardly at an angle to the longitudinal direction L from a centre section 23, 24 of the second part 20. The four legs 22a-d extend in a symmetrical manner about the longitudinal direction. Two of the legs 22a, 22d substantially have the same length respect each other. The other two of the legs 22b, 22c also have the same length respect to each other. In this embodiment, legs 22b, 22c are shorter than the legs 22a, 22d, however the length of the legs 22a-d may vary. Two of the legs 22a, 22d extend sideways, substantially perpendicularly to the longitudinal direction, and the other two legs 22b, 22c extend in a smaller angle with the longitudinal direction.

[0193] The centre section 23 is a flexible section 24 configured for being deformed and / or stretched during vaginal child delivery. At least a section of the centre section 23 constitutes the flexible section. Each of the legs 22a-d and the strip section 20a constitute stiff sections of the second part 20. The stiff sections are configured for substantially maintaining their shape. The legs 22a-d achieve the stiff material properties through a greater material thickness. The combination of the stiff sections and flexible section of the second part ensures the device's stability and effectiveness, significantly reducing the risk of perineal damage by providing steady support and minimizing excessive and / or too fast stretching during the vaginal child delivery. The adaptability of the device, catering to varying physiological conditions, adds an extra layer of versatility, making it well-suited for diverse applications in different childbirth scenarios.

[0194] As is seen in Fig. 1, the second part 20 further comprises an attachment element 34 at the inner surface 32 configured for attachment to a surface of the female body. It is to be understood that a similar attachment element will be provided on the embodiments shown in Figs. 47-54 even though not shown in these figures. The attachment element 34 shown in Fig. 1 is provided on each of four legs 22a-d and one coherent attachment element, but is could be provided as several separate attachment elements as shown for example in Fig. 7.

[0195] The attachment element 34 is here in the form of an adhesive, more preferred an at least two-layer chemical adhesive, more preferred at least a three-layer chemical adhesive, arranged on the inner surface 32 of the second part, possibly a non-stretch adhesive. In an embodiment, the attachment element 34 is a pressure-sensitive adhesive, a tissue specific glue, and / or a combination of these. This ensures reliable adherence even in areas with hair. The adhesive 34 provides easy attachment of the device 1 to the outside of the female body. The adhesive 34 is provided on the inner surface of the legs 22a-d of the second part. The section of the second part 20, that is not covered with adhesive, is referred to as the flexible section. The shape of the flexible section may vary depending on the different needs of the consumer / user. In the embodiment in Fig. 1, the adhesive of the attachment element 34 is also provided on a strip section 20a of the second part 20.

[0196] In the following, reference will be made primarily to the embodiments in Figs. 1-44. It is to be understood that these perineum damage-reducing devices are also provided with a primary reinforcing element as described with reference to Figs. 45-54, even though it is not shown in Figs. 1-44. Secondary and / or tertiary reinforcing elements may also be used in these embodiments.

[0197] In the embodiment of Fig. 1, the body section 13 comprises four arms 12a-d, each extending outwardly at an angle to the longitudinal direction L from a centre section of the body section 13. The four arms 12a-d extend in a symmetrical manner about the longitudinal direction. An advantage by providing four arms 12a-d may be that in the event that one of the arms collapses during use, the first part may still work when at least one of the other arms 12a-d have not collapsed. Two of the arms 12a, 12d substantially have the same length. The other two of the arms 12b, 12c also have the same length. The other two of the arms 12b, 12c are shorter than the arms 12a, 12d, however the length of the arms 12a-d may vary. Two of the arms 12a, 12d extend sideways, substantially perpendicularly to the longitudinal direction, and the other two of the arms 12b, 12c extend in a forward direction, forming the distal end of the first part.

[0198] Fig. 2 is a frontal schematic view depicting a perineum damage-reducing device 1 during use on / in a female body 51 prior to the passage of a child 52 through the vaginal opening 6. The second part 20 is attached to the perineum, situated between the posterior part of the vaginal opening 6 (also referred to as the introitus vagina), and the anus 3, aiming to safeguard this region during childbirth. Various embodiments may feature distinct shapes and dimensions of the second part 20, accommodating factors such as the anatomical variability of the female body 51, as exemplified in the figures and embodiments of the drawing.

[0199] As the child's head 52 progresses through the vaginal opening 6, the length of the posterior part of the vaginal opening 6 may experience a doubling or tripling, contingent upon the child's 52 circumference and head presentation. To accommodate these variations, at least the flexible section 24 is composed of elastic materials, ensuring the device withstands stretching without compromise.

[0200] In Fig. 3, which illustrates a cross-sectional perspective of a female body with a perineum damage-reducing device 1 appropriately positioned during vaginal child delivery, the device 1 is in a non-flat condition. The neck section 9 of the first part 10 is bent so that the device 1 extends from the second part 20 arranged on the perineum, over the posterior part of the introitus vagina 6 and into the vagina, and the first part matches the shape of the vaginal wall. The device 1 thus complies with the anatomy of the average female body.

[0201] As is seen in Fig. 2, the second part 20 does not cover the anus 3, but extends on either side of it. The device 1 is designed to match the typical distance between the vaginal opening 6 and the anus 3. However, recognizing the natural variations in anatomical dimensions among individuals, the device allows for customization through cutting. If the distance is smaller than average, the device 1 can be trimmed to have both the first part 10 and the second part 20 of equal lengths or with a shorter second part 20. This adaptable feature emphasizes the device's versatility, making it suitable for a range of female body sizes and shapes without sacrificing its protective efficacy.

[0202] Ruptures of the perineum during vaginal child delivery typically originates from the posterior aspect of the vaginal opening 6, and the significance of shielding this region is therefore high. The second part 20 adheres to a substantial portion of the perineum, ensuring comprehensive protection throughout the entire course of vaginal childbirth. The design choice of the second part 20 serves to extend coverage over a considerable portion of the perineum and adjoining regions, thereby enhancing the device's efficacy in averting potential complications during childbirth.

[0203] The first part 10 provides for a large contact area between the device and the vaginal wall and between the device and the child's head 52. The large contact area 15 between the device 1 and the vaginal wall ensures that a larger area of the vaginal tissue is protected from damage, as the first part 10 provides a protective layer to the tissue it covers and evens out loads. The provision of the primary reinforcing element allows the first part to transfer loads from the section, which is in contact with the child's forehead, i.e., the section subject to the highest loads, to other sections. In the stage of labour shown in Fig. 3, where the child's forehead is just about to pass through the vaginal opening, the loads on the introitus vagina and the perineum are very high. At this stage, the combination of a primary reinforcement transferring loads to parts of the vaginal wall deeper inside the vagina and the second parts supporting the perineum on the exterior side is particularly advantageous.

[0204] The large contact area between the device 1 and the child may also imply a better protection of the child as there will be less direct contact between the vaginal wall and the child, the first part 10 potentially acting as a slip sheet.

[0205] Furthermore, ahe large contact area between the device 1 and the child's head 52 also reduce the risk of the device 1 collapsing and / or being displaced since the force that the child's head 52 exerts on the first part 10 occurs with a distance to a distal end 17 of the first part 10 which is furthest from the second part.

[0206] The first part 10 is arranged between the vagina wall and the baby's head 52. This may contribute to retaining the first part 10 in place. When contact has been established between the first part 10 and the child's head 52, the first part 10 may travel with the child out of the vaginal opening.

[0207] A specified angle A between the first part 10 and the second part 20 may contributes to achieving an optimal fit of the device 1. Recognizing the inherent physiological variations among individuals, the angle A is designed to be adaptable, allowing for potential adjustments during the course of child delivery. This adaptability ensures that the device can accommodate diverse anatomical considerations.

[0208] Moreover, to cater to the unique characteristics of each female body 51, a range of devices may be offered, each featuring distinct angles and / or sizes for the first and second parts. This variety allows for a personalized selection based on individual requirements and ensures the device's effectiveness across a spectrum of physiological differences. It may also be possible to adapt the angle during use or the device may be soft so that the angle is determined solely by the anatomy of the female body, when the first part and the second parts comes into contact with the vaginal tube and the perineum, respectively.

[0209] The device is applied by arranging the perineum damage-reducing device 1 on the female body 51 with the first part 10 extending into the vaginal tube and at least a first section of the first part at a posterior part of introitus vagina and with the second part 20 extending along the perineum, such that the inner surface is in contact with surfaces of the female body. The device 1 is attached by at least one attachment element 34 on the second part 20 to a surface of the female body 51.

[0210] The devices shown in Fig. 45-54 are shown as having the primary reinforcement on the outer surface, i.e., the surface facing the child, but is also possible to provide it on the inner surface, i.e., the surface facing the vaginal wall.

[0211] The device 1 is bent at the neck section 9 of the first part 10 when arranged on the female body 51, so that the first part 10 and the second part 20 extend at an angle A in relation to each other. The device 1 is arranged so that in use during vaginal childbirth, the first part 10 is located between the vaginal walls and the child's head 52.

[0212] In an embodiment, the device 1 is applied to the female body 51 when the child's head 52 has passed the symphysis pubis 53 and the child's neck 54 is opposite the symphysis pubis 53, i.e later than shown in Fig. 3. This may provide more space of applying the device. In an embodiment, the first part 10 of the device 1 may travel with the child's head 52 towards the introitus vagina, when contact between the device 1 and the child's head 52 has been established as shown in Fig. 3. This may be referred to as intentional expulsion or acceptable expulsion of the first part. The primary reinforcing element will, however, reduce the likelihood of expulsion and hence reduce the risk of unintentional expulsion.

[0213] In the subsequent text, identical reference numbers are assigned to components serving the same function, even though they may not be identical. Distinctions between them will be elucidated in the descriptions.

[0214] Referring now to Figs. 4-6, an embodiment of the device 1 is shown. The device 1 resembles that of Fig. 1, however the flexible section 24 of the second part 20 has a different shape. This shape of the flexible section 24 has proven to be particularly advantageous as a larger flexible section 5 may increase the stability of the attachment of the second part. The four arms 12a-d here have substantially the same length and are larger than in Fig. 1, providing for a larger contact area between the device and the child's head and / or the vaginal wall, as depicted in Fig. 6. The body section comprises four arms, each arm extending at an angle relative to both the longitudinal direction and the width direction. Two arms 12b, 12c extend in a forward direction towards the distal end of the first part 10 and two arms 12a, 12d extend in a backward direction towards the proximal end of the first part 10. The body section 13 may be said to have a flower shape. The shape of the arms 12a-d enables the first part 10 to spread out further in the vagina in multiple directions, as shown in Fig. 6 compared to Fig. 3. In the embodiment of Figs. 4-6, the four arms 12a-d have substantially the same length and width.

[0215] As evident from the variations in the size of the first part 10 illustrated in Fig. 1 compared to the size shown in Fig. 4, this component can be adjusted to accommodate specific anatomical variations. Similarly, the size of the second part 20 may vary, as seen by comparing Fig. 1 and Fig. 19. This flexibility underscores the device's capacity to cater to diverse anatomies, providing a tailored and effective solution for a range of individuals.

[0216] Likewise, the size (i.e. width, length and thickness) of the neck section 9 may vary between different embodiments. The neck section 9 of the first part 10 is placed over the vagina opening and inside of the vagina as seen in Figs. 3 and 6 for example. The neck section 9 protects and spreads the pressure by the child's head over a bigger surface (the neck section width).

[0217] In the embodiments of Figs. 7-9, the first part 10 of the device 1 comprises an anchor 19. The anchor may provide a good contact with the child's head 52 and / or the vaginal tube. The device 1 is shown from the inner surface.

[0218] In Figs. 8 and 9, the second parts 20 have legs and a strip section 20a that are thicker than the centre section 23 of the second part 20. The increased thickness of the legs and the strip section 20a results an increased stiffness for improving stability of the device. The neck section 9 of Fig. 8 and 9 is shorter than the neck section 9 of Fig. 7.

[0219] The anchor 19 may assist a birth helper in positioning the first part 10 correctly, since the first part 10 can be pushed in between the child's head and the vagina wall by pushing the anchor 19, preferably using two fingers.

[0220] In an embodiment, the anchor 19 helps provide a proper contact between the child's head and the device. In the embodiment of Figs. 8 and 9, the anchor protrudes at the inner surface of the device, however, the anchor may additionally or alternatively protrude at the outer surface of the device, as shown in the embodiments of Figs. 39-41.

[0221] Fig. 10 shows the embodiments of Figs. 7-9 in use.

[0222] Figs. 11 and 12 show an embodiment where the neck section 9 of the first part 10 is longer than the body section 13 of the first part, and where the body section is structurally very simply, with no distinct arms. The width of the neck section 9 increases towards the distal end.

[0223] In Figs. 13-15, the body section 13 comprises two arms 12a, 12d extending symmetrically about the longitudinal direction. The second part 20 comprises five attachment elements 34 which are provided separately on each of the legs 22a-d and on the strip section 20a. In such embodiments, the attachment element 34 may be covered by five separate covers (not shown) to facilitate attachment of the second part 20 to the female body, and one or more covers may also be used for covering one or more attachment elements shown in the other figures.

[0224] In Figs. 16-18, the body section 13 comprises two arms 22a, 22d that extends away from the centre of the first part 10 in approximately opposite directions. The arms 12a, 12d have a curvature extending slightly in a backwards direction towards the proximal end 91 of the device 1. This device does not comprise a strip section 20a.

[0225] In Figs. 19-21, the second part 20 comprises two outer legs 22a, 22d of substantially the same length. Two inner legs 22b, 22c have substantially the same length but the inner legs 22b, 22c are shorter than the outer legs 22a, 22d. The outer legs 22a, 22d have substantially the same length as the arms 12a-d of the first part 10.

[0226] In the embodiment of Figs. 22-24, the inner legs 22b, 22c of the second part have substantially the same length as the arms 12a-d of the first part 10. The outer legs 22a, 22d are longer than the inner legs 22b, 22c of the second part 20 and the arms 12a-d of the first part 10 for covering a providing a larger contact area and thereby cover a larger area of the perineum. Other lengths and sizes of the legs are also possible, see Figs. 31- 33.

[0227] Fig. 25 shows a device comprising an anchor 19. The legs 22a-d of the second part 20 vary in size.

[0228] In Fig. 26, the two arms 12a, 12d are longer compared to the two arms of Fig. 13.

[0229] Fig. 27 resembles the embodiment of Fig. 9, however the first part 10 comprises four arms 12a-d.

[0230] In Fig. 28 the device is seen from the inner surface. In Fig. 28-30 the first part 10 comprises three arms 12a-c. An inner arm 12b is larger than two outer arms 12a, 12c.

[0231] In Fig. 31, the device is seen from the outer surface. It is to be understood that all figures shown without attachment elements are seen from the outer surface.

[0232] In Fig. 31-33, the second part 20 comprises four arms 22a-d, wherein two outer arms 22a, 22d are substantially longer than two inner arms 22b, 22c.

[0233] In Figs. 34 and 35, the arms 12a, 12d of the first part 10 extend at an angle of substantially 90 degrees relative to each other.

[0234] Fig. 36 resembles the embodiment of Fig. 9, however two inner arms 12b, 12c of the first part 10 are shorter than two outer arms 12a, 12d of the first part 10.

[0235] In Fig. 37, the attachment element 34 only covers the legs 22a-d of the second part 20.

[0236] The attachment element 34 of Fig. 38 covers a smaller section 20a of the centre section 23 of the second part. In Figs. 39-41, different devices comprising an anchor are shown. These anchors are provided on the inner surface of 5 the device. An anchor may additionally or alternatively be provided on the outer surface of the device.

[0237] Figs. 42-44 show an embodiment where edges of the legs 22a-d of the second part 20 are chamfered, i.e. inclining, reducing the risk of the device being peeled off unintentionally.

[0238] Fig. 43 shows a cross-sectional side view of the second part 20. The legs 22a-d and a section of the centre section 23 have an increased thickness.

[0239] Fig. 44 shows a cross-sectional side view of one of the legs 22c.

[0240] In Fig. 42 the width of the neck section 9 increases towards the distal end 92 of the first part 10 until reaching a maximum, and from there the width decreases. The wider middle portion of the neck provides a large contact area where large forces resulting from contact with the child's head is expected.

[0241] In the context of the present invention, it is emphasized that the embodiments illustrated in the figures are exemplary in nature and serve as illustrations of various potential configurations of the perineum damage-reducing device. These embodiments are not intended to be exhaustive or limiting, and the scope of the invention encompasses a broader range of variations and combinations that are not explicitly depicted. As such, these embodiments are provided for illustrative purposes only, and the invention should not be construed as being confined to the specific structural or functional features illustrated in any single figure. It is expressly stated that any further variations, modifications, or combinations of features, whether explicitly described or not, fall within the ambit of the invention as defined by the appended claims. This flexibility in interpretation is designed to ensure that the invention encompasses the full spectrum of potential embodiments, allowing for innovation and adaptation in response to specific application requirements or technological advancements.

[0242] The primary reinforcing element 41 and its combinations with secondary reinforcing element 42 and tertiary reinforcing element 43 are applicable to all embodiments shown in Figs. 1-54 even if not shown.

Claims

Claims1. A perineum damage-reducing device for reducing damage to a female human body during vaginal child delivery, said female human body comprising vagina, introitus vagina, perineum, and anus, and said perineum damage-reducing device comprising: a first part configured to be inserted into the female human body via introitus vagina at a posterior part of introitus vagina, a second part configured to extend outside the female human body away from the posterior part of introitus vagina towards anus, an attachment element configured for attachment to a surface of the female human body, and a primary reinforcing element, where the second part extends in a continuation of the first part in a longitudinal direction of the perineum damage-reducing device, where the first part and the second part extend in a width direction perpendicular to the longitudinal direction, where the perineum damage-reducing device has an inner surface configured to be in contact with surfaces of the female human body and an outer surface opposite to said inner surface, and where a thickness direction of said perineum damage-reducing extends from the inner surface to the outer surface, perpendicular to the width direction and the longitudinal direction, where the attachment element is provided on the second part on the inner surface, where the first part is longer than the second part in the longitudinal direction, and where the primary reinforcing element extends along a centre axis of the first part, said centre axis being parallel with the longitudinal direction and centred on the first part in the width direction.

2. A perineum damage-reducing device according to claim 1, wherein the primary reinforcing element has a width in the width direction, which is less than 50% of the smallest width of the first part in the width direction, preferably less than 30%, more preferred less than 20%.

3. A perineum damage-reducing device according to any of the preceding claims, wherein the primary reinforcing element or a part of the primary reinforcing element extending in the first part has a width of 4-20 mm in the width direction, preferably 5-15 mm, more preferably 6-10 mm.

4. A perineum damage-reducing device according to one or more of the preceding claims, wherein, when the primary reinforcing element extends only in the first part, the reinforcing element has a length of 50-110 mm in the longitudinal direction, preferably 60-100 mm, more preferably 70-80 mm.

5. A perineum damage-reducing device according to claim 3, wherein the primary reinforcing element extends into the second part and / or where a secondary reinforcing element is provided in the second part, preferably extending in continuation of the primary reinforcing element in the first part.

6. A perineum damage-reducing device according to one or more of the preceding claims, wherein the first part comprises a neck section and a body section, wherein the neck section has a proximal end connected to the second part and a distal end connected to the body section, wherein the neck section constitutes a bending zone facilitating a bending of the perineum damage-reducing device about a primary bending axis, which is parallel to the width direction, and wherein the primary reinforcing element does not extend into the neck section.

7. A perineum damage-reducing device according to claim 6, wherein one or more tertiary reinforcing elements are provided in the neck section, providing resistance against bending about a secondary bending axis, which is parallel to the longitudinal direction.

8. A perineum damage-reducing device according to any of the preceding claims, wherein the primary reinforcing element is constituted by a thickening of a material from which the perineum damage-reducing device is made.

9. The perineum damage-reducing device according to one or more of claims 1-7, wherein the reinforcing element is embedded a sheet of flexible material between said inner surface and said outer surface.

10. The perineum damage-reducing device according to one or more of the preceding claims, wherein the primary reinforcing element has a flat end surface at a proximal end or at the joint between the first part and the second part, such as in a neck section of the first part, said flat end surface extending in the width direction and in thickness direction, preferably perpendicular to the longitudinal direction11. The perineum damage-reducing device according to one or more of the preceding claims, wherein the second part comprises a flexible section configured for being deformed and / or stretched during vaginal child delivery, and at least one stiff section configured for substantially maintaining its shape.

12. The perineum damage-reducing device according to one or more of the preceding claims, wherein the second part comprises at least two legs, preferably four legs, extending outwardly at an angle to the longitudinal direction, such as radially from a centre section of the second part, preferably symmetrically about the longitudinal direction.

13. A method for reducing perineum damage to a female human body comprising vagina, introitus vagina, perineum, and anus during vaginal child delivery, comprising: a) providing a perineum damage-reducing device according to any one of the preceding claims, b) inserting the first part of the perineum damage-reducing device into the female human body via introitus vagina at a posterior part of introitus vagina, so that the primary reinforcing element extends into the vagina in a direction of insertion extending away from introitus vagina, c) arranging the second part of the perineum damage-reducing device to extend outside the female human body away from the posterior part of introitus vagina towards anus, andd) attaching the at least one attachment element to a surface of the female human body.

14. The method according to claim 13, where the perineum damage-reducing de- vice is bent about a primary bending axis, which is parallel to the width direction, during step a), during step b), or prior to both step a) and step b).

15. The method according to claim 13 or 14, where the first part is bent about a secondary bending axis, which is parallel to the longitudinal direction, during step a) or prior to step a).

16. The method according to one or more of claims 13 to 15, where the first part is inserted between a wall of the vagina and a head of a child during step a).

17. The method according to one or more of claims 13 to 16, wherein the device is applied to the female body when the child's head has passed the symphysis pubis and the child's neck is opposite the symphysis pubis.

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