WO2026008109A1

WO2026008109A1 - A perineum damage-reducing device and a method for reducing damage during vaginal child delivery

Info

Publication number: WO2026008109A1
Application number: PCT/DK2024/050166
Authority: WO
Inventors: Ditte Marie Fog IBSEN; Julia SAND
Original assignee: Oasicare Aps
Current assignee: Oasicare Aps
Priority date: 2024-07-04
Filing date: 2024-07-04
Publication date: 2026-01-08
Anticipated expiration: 2027-01-04
Also published as: WO2026008857A1

Abstract

A perineum damage-reducing device for reducing damage during vaginal child delivery is disclosed. It comprises a first part configured to be inserted into a female body via introitus vagina at a posterior part of introitus vagina, and a second part configured to extend outside the female body away from the posterior part of introitus vagina towards anus. The second part extends in a continuation of said first part in a longitudinal direction of said perineum damage-reducing device, and said second part comprises a flexible material. An inner surface extends over the first part and the second part and is configured to be in contact with surfaces of the female body, and an outer surface opposite to said inner surface. The perineum damage-reducing device has a width direction perpendicular to the longitudinal direction, and a thickness direction perpendicular to the width direction and the longitudinal direction. The second part comprises at least one attachment element at the inner surface configured for attachment to a surface of the female body. The first part is longer than the second part in the longitudinal direction. A method for reducing damage during vaginal child delivery is also disclosed.

Description

Title

A perineum damage-reducing device and a method for reducing damage during vaginal child delivery

Field of the Invention

The present invention relates to a perineum damage-reducing device for reducing damage during vaginal child delivery, comprising: a first part configured to be inserted into a female body via introitus vagina at a posterior part of introitus vagina, and a second part configured to extend outside the female body away from the posterior part of introitus vagina towards anus, said second part extends in a continuation of said first part in a longitudinal direction of said perineum damagereducing device, and said second part comprising a flexible material; an inner surface extending over the first part and the second part and being configured to be in contact with surfaces of the female body; an outer surface opposite to said inner surface; the perineum damage-reducing device having a width direction perpendicular to the longitudinal direction, and a thickness direction perpendicular to the width direction and the longitudinal direction; and wherein the second part comprises at least one attachment element at the inner surface configured for attachment to a surface of the female body. The invention further relates to a method for reducing damage during vaginal child delivery.

Background of the Invention

Damage to the perineum, i.e. the area between the opening of the vagina and the anus, is a common complication following vaginal 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.

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.

Perineal protection during vaginal child delivery can be achieved manually by healthcare personnel, usually midwives, where they place their thumb and index fingers alongside 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.

To address the challenges associated with manual perineal support and reduce the need for trained healthcare personnel, attempts have been made to develop devices aimed at reducing perineal damage and safeguarding the perineum during childbirth. One such device is described in WO 09101186 Al. 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 personal report that the device is subject to spontaneous, unintended expulsion during child birth 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. There is therefore a need for an improved solution that ensures secure placement and sustained protection during the vaginal child delivery process.

Summary of the Invention

It is therefore an object of the invention to provide an alternative device that seeks to overcome these shortcomings by providing a perineum damagereducing device that not only effectively protects the perineum but also remains securely in place during childbirth, offering a reliable solution for women undergoing vaginal child delivery. According to an aspect of the invention, this and further objects are achieved with a perineum damage-reducing device as described in the introduction, characterized in that the first part is longer than the second part in the longitudinal direction.

An advantage of the invention is that 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.

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 which can be determined by experiments without undue burden.

By providing a first part of the device that is 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 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. Likewise, a large contact area between the device and the child may imply a better protection of the child as there will be less direct contact between the vaginal wall and the child. Further, a large contact area between the device and the child 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 occurs with a distance to a distal end of the first part which is furthest from the second part. In an embodiment, it may be acceptable that the first part of the device travels with the child when contact between the first part of the device 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.

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 in an angle relative to each other. It will be understood that the longitudinal direction is in relation to an flat condition of the device, i.e. when the inner and outer surfaces of the device are planar.

It is to be understood that the vaginal wall forms part of the vaginal tube.

The wordings introitus vagina and vaginal opening are used interchangeably throughout this application.

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. In addition to relieving the tissue of the perineum, this may help the first part to remain in contact with the vaginal tube even though not attached to it.

It will be understood throughout this description, that support of the perineum by the device may comprise of; 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 child birth.

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 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 stay in contact with the tissue at all times.

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 parts. It is to be understood that the first part may be bent when inserted into the introitus vagina. A small bending and/or expulsion of the first part may be acceptable as it 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.

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.

In an embodiment, the first part comprises a neck section and a body section, said neck section having a proximal end connected to the second part and a distal end connected to the body section, said neck section being more narrow than the body section in the width direction perpendicular to the longitudinal direction. By providing a more narrow neck section, the device may comply with the anatomy of the female 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 introitus 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.

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.

The body section and/or neck section may be made of a medical-grade elastomer, which is flexible yet firm enough to protect against internal tears during childbirth.

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.

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 - 50 mm.

In an embodiment, the neck section is bendable and/or arranged with a bend, so as to in use be able to extend from the second part arranged on the perineum, over the posterior part of the introitus vagina and into the vagina. The bendable nature of the neck section allows it to extend from the perineum, over the posterior part of the introitus vagina to the body section inside the vagina. This adapta- bility, 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.

The bendable nature of the first part and the connection to the second part 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.

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 1 mm to 10 mm, preferably 1 mm to 4 mm, more preferably 1mm 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.

In an embodiment, the second part is adapted to maintain the device in place during childbirth through adhesion and/or absorption of forces, whereas the first part is configured for providing a protective barrier to the vaginal wall and/or facilitate vaginal child delivery. 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.

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.

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. 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.

In an embodiment, the stiff section of the second part is adapted to maintain the device in place during child birth.

The references to a stiff section and flexible section is not 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.

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.

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

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

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 be compromised.

In an embodiment, the second part comprises at least one reinforcing element for improving the stability of the device, said reinforcing element either form- ing part of the stiff section or supplementing it. A reinforcing element may also or alternatively be provided in the first part to prevent it from collapsing.

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

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.

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

In an embodiment, the body section comprises four arms, each arm extending 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.

In an embodiment, the first part has a width of 30 to 400 mm, preferably

125 to 350 mm, more preferably 200 to 300 mm. 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.

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.

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. 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 as described above with reference to the arms of the first part. The legs may extend at angles to both the longitudinal direction and the width direction as also described above with reference to the arms of the first part. Some legs may be intended primarily for supporting in a horizontal direction, while others are intended primarily for supporting in a vertical direction.

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 rup- tures. 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.

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.

In an embodiment, the legs of the second part hart a higher stiffness than the first part of the device. This may enable reinforcement of 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 may ensure that at least part of the second part is stable.

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.

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

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

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

The device's thickness, ranging from 0.1 mm to 10 mm, with the attachment element covering specific surfaces, ensures effective attachment to the female body's outside area.

In an embodiment, a 3-layer chemical provides strong attachment.

In an embodiment, the device further comprises peeling taps for providing quick removal in emergency situations.

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 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.

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

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.

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.

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).

In an embodiment, the 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.

In an embodiment, the 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).

In an embodiment the device is made from a flexible material, which may for example be thermoplastic elastomers. At least a section of the first part and at least a section of the second part may be made from the same material.

In an embodiment, the attachment element, preferably an adhesive, covers a part of the inner surface of the second part, such as the inner surface of the at least two legs and/or a strip part, so as to attach the device to the outside area of the female body.

In an embodiment, the attachment element is an adhesive, preferably a 3- layer chemical adhesive.

In an embodiment, the second part of the device further comprises a peeling tap, preferably 2 peeling taps, more preferred 4 pealing taps to enable the device to be removed quickly in emergency situations.

By arranging a peeling tap on each leg of the second part, it may be possible to quickly remove the device by pulling the tap at the end of the leg, so as to peel each leg free from adhesion to the skin without causing damage to the skin.

The flexible material of the device may be cutable, allowing it to be cut to size. This is useful in cases where the area between the posterior part of the introi- tus vagina and anus is smaller than average. Another advantage of using cutable material is that an epsiotomi may be performed without removing the device. Likewise, the first part may be cutable to allow adaptation of it's size and/or shape.

In one embodiment, the attachment element comprises an adhesive. This may help the second part of the device to remain in place during use.

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.

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.

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.

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.

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 may allow the application of the device, while some part of the attachment element remain covered, thus reducing the risk of unintentional attachment.

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.

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.

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

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. In an embodiment, the device comprises a viscoelastic polymer.

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.

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 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.

In one embodiment, the flexible material comprises a transparent material. The transparent material may allow the user to continuously inspect the tis- sue 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.

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

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.

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.

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.

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.

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

The device may be is made of a sheet of flexible material. 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, mem- brane, film, panel, plate, board, plank, or any other term conveying a planar structure.

In a second aspect of the present disclosure, a method for reducing damage, preferably to the perineum, during vaginal child delivery, comprising: providing a perineum damage-reducing device according to any one of the preceding claims; arranging the perineum damage-reducing device on the female body with the first part 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 extending along the perineum such that the inner surface is in contact with surfaces of the female body; and attaching at least one attachment element on the second part to a surface of the female body.

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.

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.

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

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

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

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

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

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

Fig. 6 is a cross-sectional view of a female body and a perineum damagereducing device in use during vaginal child delivery;

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

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

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

Fig. 10 is a cross-sectional view of a female body and a perineum damagereducing device in use during vaginal child delivery;

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

Fig. 12 is a cross-sectional view of a female body and a perineum damagereducing device in use during vaginal child delivery;

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

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 damagereducing device in use during vaginal child delivery;

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

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

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

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

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

Fig. 21 is a cross-sectional view of a female body and a perineum damagereducing device in use during vaginal child delivery;

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

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

Fig. 24 is a cross-sectional view of a female body and a perineum damagereducing device in use during vaginal child delivery;

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

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

Fig. 1 is a perspective view of a perineum damage-reducing device according to an embodiment;

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

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

Fig. 30 is a cross-sectional view of a female body and a perineum damagereducing device in use during vaginal child delivery;

Fig. 31 is a front view of a perineum damage-reducing device according to an embodiment;

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

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

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

Fig. 35 is a cross-sectional view of a female body and a perineum damagereducing device in use during vaginal child delivery;

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

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

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

Fig. 39 is a perspective view of a section of a first part of a perineum dam- age-reducing device according to an embodiment;

Fig. 40 is a perspective view of a section of a first part of a perineum dam- age-reducing device according to an embodiment;

Fig. 41 is a perspective view of a section of a first part of a perineum dam- age-reducing device according to an embodiment;

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

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

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

Detailed Description

Fig. 1 is a front view illustration of an embodiment of a perineum damagereducing device 1 for reducing damage during vaginal child delivery, comprising a first part 10 configured to be inserted into a female body via introitus vagina 6 at a posterior part of introitus vagina (see Fig. 2), and a second part 20 configured to extend outside the female body away from the posterior part of introitus vagina towards anus 3. In the flat condition shown in Fig. 1, the second part 20 extends in continuation of the first part 10 in a longitudinal direction L of the perineum dam- age-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. 1, the inner surface 32 of the device faces the viewer. 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 may be the state of delivery.

The first part 10 comprises a neck section 9 and a body section 13. The neck section 13 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 more narrow 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. 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.

The second part 20 comprises an attachment element 34 at the inner surface 32 configured for attachment to a surface of the female body. The attachment 34 is here a non-stretch adhesive. The attachment element 34 is provided on each of four legs 22a-d. Each leg 22a-d extends outwardly at an angle to the longitudinal direction L from a centre section 23 of the second part 20. The legs 22a-d extend in a symmetrical manner about the longitudinal direction L as described above with reference to the arms of the first part. In this embodiment, the attachment element 34 also covers a strip section 20a of the second part 20. The second part 20 has 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.

The first part 10 and at least a part of the centre section 23 of the second part 20 has a thickness smaller than a thickness of the legs 22a-d of the second part 20. This may enhance proper attachment of the legs 22a-d during vaginal child delivery, as the increased thickness of the legs may improve stability of the device 1. The flexible section 24 of the second part 20 has substantially the same thickness as the first part and may have a smaller thickness than the legs 22a-d.

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. In an embodiment, the attachment element 34 is a pressure-sensitive adhesive, a tissuespecific 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 20 and a strip section 20a of the centre section of the second part 20. 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.

The first part 10 is longer than the second part 20 in the longitudinal direction L. The first part 10 shown in Fig. 1 has a length of approximately 132 mm, and the second part 20 has a length of approximately 63 mm. In this embodiment, the neck section 9 is longer than the body section 13 in the longitudinal direction L. In other embodiments, the body section 13 is longer than the neck section 9.

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 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.

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.

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. The device 1 complies with the anatomy of the average female body.

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 customiza- tion 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.

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.

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. Likewise, the large contact area between the device 1 and the child may 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. The 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.

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.

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. 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.

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. 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 child birth, the first part 10 is located between the vaginal walls and the child's head 52.

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.

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

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 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

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.

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).

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. 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.

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.

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.

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

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.

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.

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. 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.

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.

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

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

Fig. T1 resembles the embodiment of Fig. 9, however the first part 10 comprises four arms 12a-d.

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.

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.

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.

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.

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.

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

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 the device. An anchor may additionally or alternatively be provided on the outer surface of the device.

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.

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.

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

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.

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.

Claims

PATENT CLAIMS

1. A perineum damage-reducing device (1) for reducing damage during vaginal child delivery, comprising: 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 configured to extend outside the female body away from the posterior part of introitus vagina towards anus, said second part extends in a continuation of said first part in a longitudinal direction (L) of said perineum damage-reducing device (1), and said second part (20) comprising a flexible material, an inner surface extending over the first part and the second part and being configured to be in contact with surfaces of the female body, an outer surface opposite to said inner surface, the perineum damage-reducing device having a width direction perpendicular to the longitudinal direction, and a thickness direction perpendicular to the width direction and the longitudinal direction, and wherein the second part comprises at least one attachment element at the inner surface configured for attachment to a surface of the female body, c h a r a c t e r i z e d in that in that the first part is longer than the second part in the longitudinal direction.

2. The perineum damage-reducing device according to claim 1, wherein 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

3. The perineum damage-reducing device according to any one of the preceding claims, wherein the first part comprises a neck section and a body section, said neck section having a proximal end connected to the second part and a distal end connected to the body section, said neck section being more narrow than the body section in the width direction perpendicular to the longitudinal direction.

4. The perineum damage-reducing device according to any one of the preceding claims, wherein the first part has a thickness smaller than a thickness of at least a section of the second part.

5. The perineum damage-reducing device according to any one of claims 3 or 4, wherein at least the neck section of the first part is bendable and/or arranged with a bend, so as to in use be able to extend from the second part arranged on the perineum, over the posterior part of the introitus vagina and into the vagina.

6. The perineum damage-reducing device according to any one 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.

7. The perineum damage-reducing device according to any one of claims 3 to 6, wherein the body section comprises at least two arms, preferably four arms, extending outwardly at an angle to the longitudinal direction, such as radially from a centre section of the body section, preferably symmetrically about the longitudinal direction.

8. The perineum damage-reducing device according to any one of claims 3 to 7, wherein the body section comprises four arms, each arm extending at an angle relative to both the longitudinal direction (L) and the width direction (W), preferably two arms extending in a forward direction towards the distal end of the first part (10) and two arms extending in a backward direction towards the proximal end of the first part (10) or in a sideward direction.

9. The perineum damage-reducing device according to any one of the pre- ceding claims, wherein the second part comprises at least two legs, preferably four arms, 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.

10. The perineum damage-reducing device according to claim 9, wherein 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.

11. A method for reducing damage, preferably to the perineum, during vaginal child delivery, comprising:

- providing a perineum damage-reducing device according to any one of the preceding claims,

- arranging the perineum damage-reducing device (1) on the female body with the first part 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 extending along the perineum such that the inner surface is in contact with surfaces of the female body, and

- attaching at least one attachment element on the second part to a surface of the female body.

12. The method according to claim 11, wherein the perineum damagereducing device (1) is bent at a neck section of the first part when arranged on the female body, so that the first part and said second part extend at an angle in relation to each other.

13. The method according to claim 11 or 12, wherein the device is arranged so that in use during vaginal child birth, the first part is located between the vaginal walls and the child's head.

14. The method according to any one of claims 11 - 13, 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.

15. The method according to any one of claims 11 - 14, further comprising the step of: allowing the first part (10) of the device (1) to travel with the child's head (52) towards the introitus vagina.