Perineal injury reduction device and method for reducing injury during transvaginal delivery of fetus

Abstract

A perineal injury reduction device for reducing injury during transvaginal delivery of a fetus is disclosed. The perineal injury reduction device is configured to be positioned outside a female body, on the perineum. The device comprises: a second portion formed from a sheet of flexible material; an inner surface configured to contact a surface of the female body; an outer surface opposite the inner surface; at least one attachment element, preferably an adhesive, arranged at the inner surface, configured for attachment to the perineum; and two arms and / or two legs adapted to extend along the perineum away from the second portion so as to support the perineum during vaginal delivery. A method for reducing injury during transvaginal delivery of a fetus is also disclosed.

Description

Technical Field

[0001] The present invention relates to a perineal injury reduction device for reducing injury during vaginal child delivery, the perineal injury reduction device being configured to be positioned outside a female body, on the perineum, the device 1 comprising: a second portion 20 formed of a sheet of flexible material; an inner surface configured to contact a surface of the female body; an outer surface opposite to the inner surface; at least one attachment element, preferably an adhesive, arranged at the inner surface and configured to be attached to the perineum; and two arm members 22a, 22b and / or two leg members 22c, 22d, the two arm members and / or two leg members being adapted to extend along the perineum away from the second portion 20 so as to support the perineum during vaginal childbirth.

[0002] The present invention further relates to a method for reducing trauma during vaginal delivery of a fetus. Background Art

[0003] Childbirth is a transformative and joyful experience, but it often carries the risk of perineal injury, a common complication associated with vaginal birth. The perineum, the area between the vaginal opening and the anus, is particularly susceptible to injury, which manifests as perineal tears, a significant concern for both rapid postpartum recovery and long-term health.

[0004] Perineal tears typically occur during vaginal births, affecting the skin and soft tissue structures that separate the vagina from the anus, particularly at the posterior portion of the vaginal entrance. The severity of these tears, especially those involving the anal or urethral sphincter, can lead to complications such as incontinence, pain, and sexual dysfunction. Alarming statistics show that up to 90% of mothers experiencing a first-time vaginal birth experience some form of perineal injury, making it the most prevalent obstetric injury.

[0005] Although prompt detection and immediate suturing of sphincter injuries after delivery can mitigate some of the risks, up to 50% of patients still experience challenges such as fecal or urinary incontinence, pain, or sexual dysfunction. These complications significantly impact women's quality of life, highlighting the need for effective perineal protection during childbirth.

[0006] Traditionally, healthcare providers (primarily midwives) have used a manual technique to support the perineum during vaginal birth. This involves placing their thumb and index finger along the sides of the vaginal entrance (commonly known as the introitus). However, the effectiveness of this manual method depends on the healthcare provider's experience and training, which can be problematic, particularly in resource-limited settings and developing countries, where appropriate training may be lacking.

[0007] In response to the challenges associated with artificial perineal support and the need for trained healthcare personnel, attempts have been made to develop devices designed to reduce perineal tears and protect the perineum during childbirth. One such device is described in WO 09101186A1. While the device is somewhat effective in protecting tissue in the posterior portion of the vaginal entrance, the device suffers from several significant drawbacks - it requires the involvement of trained healthcare personnel, thereby limiting its widespread applicability and accessibility, and, in the experience of healthcare personnel, the device has a tendency to spontaneously discharge during childbirth, particularly when subjected to the forces exerted by the baby during labor. This limitation poses a risk to the efficacy of the device in providing continuous perineal protection, thereby highlighting the need for improved solutions to ensure safe placement and continuous protection throughout the entire childbirth process. Summary of the Invention

[0008] It is therefore an object of the present invention to provide an alternative device which seeks to overcome these disadvantages by providing a perineal trauma reduction device which not only effectively protects the perineum but also remains securely in place during childbirth, thereby providing a reliable solution for women undergoing vaginal childbirth.

[0009] According to one aspect of the present invention, this object and further objects are achieved by a perineal injury reduction device for reducing injury during vaginal delivery of a fetus, the perineal injury reduction device being configured to be positioned outside the female body, on the perineum, the device comprising: a second portion 20 formed from a sheet of flexible material; an inner surface configured to contact the surface of the female body; an outer surface opposite to the inner surface; at least one attachment element, preferably an adhesive, arranged at the inner surface and configured to attach to the perineum; and two arm members 22a, 22b and / or two leg members 22c, 22d, the two arm members and / or two leg members being adapted to extend along the perineum away from the second portion 20, thereby supporting the perineum during vaginal delivery.

[0010] It will be understood throughout this specification that support of the perineum by the device may include supporting the perineum during vaginal birth and / or reducing the rate / acceleration of stretching of the perineum.

[0011] In an embodiment, the device 1 further comprises a first portion 10 formed of a flexible material and configured to be disposed inside the vagina via the vaginal entrance at a posterior portion of the vaginal entrance.

[0012] An advantage of the present invention is that the perineal trauma reduction device provides a protective effect by distributing perineal tension over a wide surface area, not only over the area to which the second portion is attached, but also to the vaginal wall via the neck portion and / or the first portion. Furthermore, the device can slow the dilation time of the perineum, thereby minimizing the risk of rupture.

[0013] In an embodiment, the device 1 further comprises a neck portion 9 connected to the first portion 10 at one end and to the second portion 20 at an opposite end.

[0014] The combination of the first portion, the neck portion, and the second portion facilitates manipulation of the perineal trauma reduction device because it ensures that the device is correctly positioned and remains in place during use. In some embodiments, only the second portion needs to be directly attached to the female body because the shape of the first portion mechanically connects it to the female body.

[0015] The shape of the first part ensures that it is correctly positioned along the vaginal wall at the rear portion of the vaginal entrance. This means that the midwife only needs to ensure that the second part is correctly attached. This is advantageous because once the first part is inserted, it may be difficult to see the first part and therefore difficult to know whether the first part is correctly positioned. This means that the device can be used by midwives with lower or unskilled skills (such as midwives in developing countries), who often have no training or have only received very basic training. It may also be useful for well-trained midwives such as health workers, midwives and doctors.

[0016] In an embodiment, the neck portion is bendable and / or arranged with a bend so as to be able to extend from a second portion 20 arranged on the perineum over a rear portion of the vaginal entrance to a first portion 10 located inside the vagina in use.

[0017] In an embodiment, the angle of the bend and / or the angle between the first portion 10 and the second portion 20 is preferably in the range of 20 to 70 degrees, more preferably 30 to 60 degrees, more preferably 30 to 40 degrees.

[0018] The inclusion of a neck portion connected to both the first and second portions facilitates manipulation of the device, ensuring proper positioning and stability during use. The flexible nature of the neck portion allows it to extend from the perineum, past the vaginal entrance, to the first portion located inside the vagina. This adaptability, preferably with an angle ranging from 20 to 70 degrees, accommodates changes in a woman's body shape during childbirth.

[0019] During vaginal delivery of a fetus, the vaginal entrance dilates, causing adjacent areas (such as the perineum) to also dilate, and thus the second portion may dilate or otherwise change shape. This means that the perineal trauma reduction device can respond to changes in the shape of a woman's body during labor so that the first portion remains in contact with the vaginal wall, even though it is not attached to the vaginal wall.

[0020] In an embodiment, the first portion 10 is adapted to maintain the device 1 in place during childbirth.

[0021] In an embodiment, the first portion 10 comprises an elongated shape adapted to extend across the interior of the vagina.

[0022] In an embodiment, the first portion 10 comprises an elongated shape adapted to extend adjacent the posterior vaginal entrance.

[0023] Internal fixation is the device's key function, using an "anchor" geometry to secure it within the vagina. This function (determined by the material's bending stiffness and the anchor geometry) supports vertical retention and adhesion. Two arms extending along the perineum provide perineal support, thereby dampening and reducing the rate of stretching during contractions.

[0024] In an embodiment, the device is arranged such that in use during vaginal delivery, the device 1 is further held in place because the force exerted by the fetal head on the first portion 10 maintains the device in place.

[0025] The rate of horizontal stretching is suppressed by the viscoelastic properties of the polymer units. Two legs extending along either side of the anus help support the perineum, thus preventing rupture.

[0026] In an embodiment, the vertical hold provided by the two legs may limit training of the perineum to a maximum of 6 cm to 7 cm.

[0027] The device has a thickness range of 0.1mm to 10mm, with the attachment elements covering specific surfaces, ensuring effective attachment to external areas of the female body. 3 layers of chemicals provide a strong attachment.

[0028] In an embodiment, the device further comprises a peeling tap for providing quick removal in an emergency.

[0029] In an embodiment, the two arms 22a, 22b extend away from the second portion 20 in generally opposite directions along the perineum, and more specifically generally along the surface of the perineum overlying the transverse perineum muscle, thereby providing perineal support.

[0030] In an embodiment, two arms 22a, 22b extend away from the second portion 20 in generally opposite directions along the perineum, with one arm extending toward each lateral perineal border (medial thigh surface).

[0031] In an embodiment, two legs 22c, 22d extend along the perineum away from the second portion 20 on each side of the anus, thereby providing perineal support.

[0032] In an embodiment, two legs 22c, 22d extend along the perineum on each side of the anus away from the second portion 20 towards the lower border of the perineum (gluteal cleft).

[0033] In an embodiment, the device has a thickness of 0.1 mm to 10 mm, more preferably 0.5 mm to 5 mm.

[0034] In an embodiment, the attachment element, preferably an adhesive, covers: the inner surface of at least two arms 22a,b and / or two legs 22c-d, and / or a portion of the inner surface of the second portion 20, thereby attaching the device 1 to an external area of ​​the body.

[0035] In an embodiment, the attachment element is an adhesive, preferably a 3-layer chemical adhesive.

[0036] In an embodiment, the device further comprises a release tab, preferably 2 release tabs, more preferably 4 release tabs, to enable the device to be quickly removed in an emergency.

[0037] By arranging a peel tab on each arm and / or leg of the device, the device can be quickly removed by pulling the tabs at the end of the arm / leg to peel each arm / leg from adhering to the skin without causing damage to the skin.

[0038] In an embodiment, the device is made of a flexible material, which may be, for example, a thermoplastic elastomer.

[0039] In an embodiment, the device comprises a viscoelastic polymer.

[0040] The device's support function helps mitigate impact forces applied during uterine contractions and / or lethal pressure and / or ligamentous changes and / or maternal pushing, thereby protecting the perineum from potential rupture. The device achieves this by utilizing its viscoelastic polymer units, which have a high loss modulus (high damping factor and / or tan delta – ratio of loss modulus to elastic modulus). This unique property allows the device to effectively absorb and dissipate the forces generated by uterine contractions, thereby promoting controlled, progressive dilation of the perineum. This function is further enhanced by the inclusion of arm and / or leg members that stretch across the perineum, working in harmony with the adhesion mechanism.

[0041] In a second aspect of the present invention, there is provided a method for reducing trauma, preferably perineal trauma, during vaginal delivery of a fetus. The method comprises:

[0042] - providing a perineal trauma reduction device 1 comprising a first portion 10, a second portion 20, and a neck portion 9 connecting the first and second portions, wherein an inner surface and an outer surface opposite the inner surface are provided, and wherein at least one attachment element, preferably an adhesive, extends partially on the inner surface of the second portion,

[0043] - placing the perineal trauma reduction device on a female body, wherein the first portion 10 is located at the posterior portion of the vaginal entrance, and wherein the second portion 20 extends along the perineum, such that the attachment element arranged on the inner surface contacts the surface of the female body, and

[0044] - Attaching the second portion 20 to said surface of the female body using said at least one attachment element.

[0045] In an embodiment, the perineal trauma reduction device 1 is bent at the neck portion 9 when positioned on a female body such that the first portion and the second portion extend at an angle relative to each other.

[0046] In an embodiment, the opposite ends of the first portion 10 are bent towards each other, preferably to obtain a generally u-shape, before the first portion is arranged in the vagina.

[0047] In an embodiment, the device is arranged such that in use during vaginal delivery, the device 1 is further held in place because the force exerted by the fetal head on the first portion 10 maintains the device in place.

[0048] In an embodiment, two of the arms extend horizontally along the perineum, and the other two legs extend from the inner vagina toward and adjacent to either side of the anus.

[0049] The perineal trauma reducing device is configured to suppress horizontal stretching by suppressing impact force from uterine contraction using viscoelastic properties of polymer units, thereby preventing rupture.

[0050] In embodiments, the viscoelastic polymeric unit has a high loss (tan delta / damping factor) modulus to facilitate resistance to horizontal stretching.

[0051] 3 layers of chemical adhesive ensure strong attachment to the skin and support vertical holding function and horizontal stretching function.

[0052] The device is configured to provide internal fixation within the vagina using an "anchor" geometry to secure the device within the vagina and facilitate vertical retention function.

[0053] In an embodiment, the performance of the internal fixation function is determined by the bending stiffness of the material and the anchor geometry.

[0054] In an embodiment, the perineal trauma reduction device includes a safe removal feature that allows for quick removal in an emergency situation, which is achieved by peel tabs on the legs and arms of the device, where the peel is oriented inward to prevent skin damage.

[0055] In an embodiment, examples of uses / method steps are:

[0056] a. Unpack the device

[0057] b. Bend the upper first part of the device (the "anchor") and insert it into the vagina

[0058] c. Use two fingers to push the anchor down inside the vagina

[0059] d. Turn the outer part of the device over and wipe the perineal area

[0060] e. Remove the first sheet to apply the lower portion of the "body" of the device to the perineum and sides of the anus using the adhesive, ensuring the anus is not covered

[0061] f. Remove the second and third sheets of paper on each side and apply the device horizontally

[0062] g. Make sure the device is properly adhered and do not use the device for more than 60 minutes

[0063] In an embodiment, examples of use / remove steps are:

[0064] h. Slowly pull the body of the device upward from the bottom toward the center.

[0065] i. Slowly pull the horizontal piece from the outside toward the center.

[0066] j. When the device is no longer adhered to the perineum, gently withdraw the device anchor from the vagina.

[0067] In an embodiment, the sheet of flexible material is elastic. Elastic refers to the material's resilience, which is the tendency of a solid material to return to its original shape after a force is applied. This is advantageous when the vaginal entrance expands, causing adjacent surfaces to expand as well. When expanded, the sheet will thus seek to return to its original shape and thus resist the expansion of the perineum.

[0068] In one embodiment, the flexible sheet may be capable of expanding to double or triple its size.

[0069] In one embodiment, the inner surface of the first part comprises a smooth surface. The smooth surface comprises a non-adhesive surface. The smooth surface can facilitate easy handling of the device because the first part will not stick to undesirable places. This is particularly useful in the event that the first part is initially placed incorrectly, which can often happen, especially for unskilled birth attendants, because the first part may not be visible due to its positioning inside the vagina. Once the second part has been attached to the surface of the woman's body, the first part will therefore be free to reposition itself and fall into place, as described above.

[0070] In one embodiment, only the second portion comprises the attachment element.

[0071] In one embodiment, the second portion comprises a middle section and two side sections, and the at least one reinforcing element extends through the middle section and outward toward the edges of the side sections. By providing reinforcing elements extending over a large area of ​​the device, the device becomes stable and easy to operate. This also ensures good force transmission from the second portion to the first portion due to the large contact area between the reinforcing element and the sheet. The large reinforcing elements also allow for good force transmission between the device and the female body.

[0072] The at least one reinforcing element may comprise two sections extending from the first portion to the second portion, said sections being interconnected at the first portion.The reinforcing element may extend to both side sections.

[0073] It is also possible to provide two or more separate reinforcing elements, each extending over both said first portion and said second portion. In this case, one reinforcing element may extend into one side section, while another reinforcing element extends into the other side section.

[0074] In one embodiment, the at least one reinforcing element further extends inwardly and rearwardly toward the middle section of the second portion. The section of the reinforcing element extending in the second portion can then have a rounded shape, preferably a U-shape. This can further stabilize the device because the contact area between the reinforcing element and the sheet is relatively large.

[0075] The reinforcing elements preferably have no sharp edges to avoid damage to the sheet.

[0076] In one embodiment, the first portion and the second portion meet at a bend and extend at an angle relative to each other, preferably in the range of 20 to 70 degrees, more preferably 30 to 60 degrees, and even more preferably 30 to 40 degrees. These angles are particularly well-suited to the anatomy of an average woman, which has proven useful because they help facilitate proper attachment of the device and that the device remains in place during use.

[0077] In one embodiment, the device is pre-shaped to have a curvature between the first and second portions in the delivery position. The delivery position refers to the state of the device when the user possesses the device, including the state of the device when the device is applied to the body. Pre-shaped means that the device is in a ready-to-use state in the delivery position. The ready-to-use state further facilitates manipulation of the device, as the device may already be adapted to the female anatomy and may not require further curvature.

[0078] Pre-forming does not restrict the device to one shape. Pre-formed devices can still be adjusted.

[0079] In an embodiment, the sheet of flexible material has a thickening at the bend. The thickening at the bend is intended to maintain the desired angle between the first and second portions, thereby preventing collapse of the device. However, the thickening should allow for some repositioning of the first and second portions relative to each other during use, for example due to a fetus pressing against the first portion.

[0080] In one embodiment, the at least one reinforcing element is elastic, thereby pulling the device toward labor. This may contribute to the device's ability to follow changes in the female body shape during labor (such as the expansion of the vaginal entrance during fetal passage). The elasticity of the reinforcing element also reduces the risk of breakage, which could result in the formation of sharp edges.

[0081] The reinforcing element may comprise a different material, or it may comprise the same material as the sheet. In the case where the reinforcing element comprises the same material as the sheet, the material of the reinforcing element may have a higher density or compactness.

[0082] The reinforcing element may comprise a polymeric material such as an elastomer, a thermoplastic elastomer, an intermediate thermoplastic elastomer, nylon, polypropylene, polyethylene, polyurethane, polycarbonate, vinyl, polytetrafluoroethylene, silicone, or a textile.

[0083] In embodiments, the reinforcing element may comprise a non-polymeric material, such as a metallic material.

[0084] In one embodiment, the reinforcing element has a higher stiffness than the sheet. This allows the reinforcing element to strengthen the device and thereby facilitate its manipulation. Stiffness refers to the degree to which an object resists deformation in response to an applied force. Stiffness ensures a stable reinforcing element.

[0085] In one embodiment, the reinforcing element is embedded in the flexible material sheet between the inner and outer surfaces. This can further facilitate handling of the device and reduce the risk of any accidental injury to the mother, fetus, or unskilled birth attendants caused by the reinforcing element. For similar reasons, the reinforcing element preferably has no sharp edges.

[0086] If the reinforcing element is not covered by a sheet element, it should preferably be biocompatible.

[0087] In an embodiment, the sheet of flexible material comprises a polymeric material, such as an elastomer, a thermoplastic elastomer, an intermediate thermoplastic elastomer, nylon, polypropylene, polyethylene, polyurethane, polycarbonate, vinyl, polytetrafluoroethylene, silicon, or a textile.

[0088] In one embodiment, the sheet of flexible material may comprise a non-polymeric material.

[0089] Flexible materials are materials that have the ability to bend or compress easily without cracking under normal conditions. Flexible materials allow the device to adapt to different shapes, which is advantageous in dynamic environments, such as during vaginal delivery of a fetus.

[0090] The sheet of flexible material may comprise one or more layers of the same material or different materials.

[0091] In one embodiment, the sheet of flexible material comprises a transparent material.The transparent material may allow the user to continuously inspect the underlying tissue during application of the device and / or during labor.

[0092] The flexible sheet of material may have perforations or grooves. This helps remove potential fluids, such as bodily fluids, from the area. This can be advantageous, as fluids can impair adhesion. This feature also protects the skin from any potential damage, as prolonged exposure to fluids can damage the skin. The perforations can also allow unskilled birth attendants to inspect the skin through the perforations, which is useful if the sheet is opaque.

[0093] The outer surface of the first portion may be smooth, at least when wet, and have low frictional resistance to human skin and hair. This may help the fetus slide over the device.

[0094] The material of the flexible sheet should be biocompatible and should not cause allergic reactions. For this reason, latex or similar allergenic materials may be less preferred.

[0095] The sheet of flexible material may be cuttable, allowing it to be cut to size. This is useful if the area between the posterior portion of the vaginal entrance and the anus is smaller than average. Another advantage of using a cuttable material is that an episiotomy can be performed without removing the device.

[0096] In one embodiment, the attachment element comprises an adhesive. This will help the device remain in place during use.

[0097] The attachment element may be provided on the sheet of flexible material forming the second portion or may be integrated into the second portion. The attachment element on the inner surface of the second portion may be provided so that the inner surface of the second portion itself is adhesive or so that the 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 is preferably made of a material that adheres to surfaces of the body that are covered with body fluids, such as vaginal discharge.

[0098] The separate attachment element may comprise an adhesive, such as a pressure sensitive adhesive or glue, for example a tissue specific glue. It may be advantageous that the attachment element is able to adhere to the location where the hair occurs to ensure good adhesion.

[0099] In one embodiment, only the inner surface of the second portion comprises attachment elements.

[0100] In the delivery position, the attachment element may be covered by the cover. This may prevent the device from accidentally attaching to other items, such as other perineal trauma reduction devices.

[0101] The cover may comprise several separate elements or be divided into two or more sections, for example by perforations, so that sections of the attachment element can be exposed independently. This would allow, for example, a middle section comprising a middle section as described above and the second part of the two side sections to be exposed and attached to the female body, while the side sections remain covered. This would allow the device to be applied while a certain part of the attachment elements remains covered, thereby reducing the risk of accidental 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.

[0102] In an embodiment, the device has a thickness of 0.1 mm to 10 mm, more preferably 0.5 mm to 5 mm. These thicknesses provide a balance between material consumption, ease of handling, and functionality. The thickness of the device can be selected based on functionality and user acceptance, i.e., from a technical perspective, the device can operate at a thickness as low as 0.1 mm, but can be thicker to accommodate user perception and acceptance.

[0103] In an embodiment, the second portion is thicker than the first portion.

[0104] In one embodiment, the first portion is thicker than the second portion.

[0105] The thickness of the first portion and / or the second portion can vary. For example, the second portion can be thicker or thinner in the middle section compared to the side sections to provide desired physical properties, or the edges of the second portion can be thinner than the rest of the portion to facilitate attachment or removal. As another example, the edges of the first portion can be thinner than the center section to make them more flexible than the center section, thereby potentially facilitating insertion or giving the first portion a shape that matches the shape of the vaginal wall.

[0106] In an embodiment, the elongated protrusion extends away from the first portion.

[0107] A second aspect of the present invention relates to a method for reducing trauma during vaginal delivery of a fetus, the method comprising:

[0108] A perineal trauma reduction device is provided comprising a first portion and a second portion, wherein a sheet of flexible material defines an inner surface and an outer surface opposite the inner surface, the inner surface extending over the first portion and the second portion, and wherein at least one reinforcing element extends over both the first portion and the second portion and stabilizes the sheet,

[0109] arranging the perineal trauma reduction device wherein the first portion is inserted into the female body via the vaginal entrance at a posterior portion of the vaginal entrance, and wherein the second portion extends outside the female body away from the posterior portion of the vaginal entrance toward the anus with the inner surface in contact with a surface of the female body, and

[0110] The second portion is attached to a surface of the female body between the posterior portion of the vaginal entrance and the anus using at least one attachment element at the inner surface.

[0111] Unless otherwise stated, embodiments and advantages described with reference to one aspect of the invention also apply to the other aspects. As an example, the possible removal of sections of the covering at different times during application of the perineal trauma reduction device described above with reference to the first aspect also applies to this method. BRIEF DESCRIPTION OF THE DRAWINGS

[0112] In the following description, embodiments of the present invention will be described with reference to the accompanying schematic drawings, in which:

[0113] Figure 1 A first embodiment of a perineal trauma reduction device is shown in a perspective view,

[0114] Figure 2 is a front view of the device according to the first embodiment,

[0115] Figure 3 is a side view of the device according to the first embodiment,

[0116] Figure 4 is a cross-sectional view of a female body and a perineal trauma reduction device in use during vaginal delivery of a fetus,

[0117] Figure 5 is a front view showing the female external genitalia during vaginal delivery of a fetus and the perineal trauma reduction device during use,

[0118] Figure 6 is a perspective view of a second embodiment of a perineal trauma reduction device,

[0119] Figure 7 is a perspective view of a third embodiment of a perineal trauma reduction device,

[0120] Figure 8 is a perspective view of a fourth embodiment of a perineal trauma reduction device,

[0121] Figure 9 is a perspective view of a fifth embodiment of a perineal trauma reduction device,

[0122] Figure 10 is a perspective view of a sixth embodiment of a perineal trauma reduction device,

[0123] Figure 11 is a front view showing the female external genitalia during vaginal delivery of a fetus and the perineal trauma reduction device during use,

[0124] Figure 12 is a side view of a device according to a sixth embodiment of a perineal trauma reduction device,

[0125] Figure 13 is a side view of the perineal trauma reduction device,

[0126] Figure 14 is a cross-sectional view of a female body and a perineal trauma reduction device in use during vaginal delivery of a fetus,

[0127] Figure 15is a cross-sectional view of a female body and a perineal trauma reduction device in use during vaginal delivery of a fetus,

[0128] Figure 16 is a cross-sectional view of a female body and a perineal trauma reduction device in use during vaginal delivery of a fetus,

[0129] Figure 17 is a perspective view of a seventh embodiment of a perineal trauma reduction device,

[0130] Figure 18 is a perspective view of an eighth embodiment of a perineal trauma reduction device,

[0131] Figure 19 is a side view of a device according to an eighth embodiment of a perineal trauma reduction device,

[0132] Figure 20 is a front view of the perineal trauma reduction device,

[0133] Figure 21 is a front view of the perineal trauma reduction device,

[0134] Figure 22 is a perspective view of a ninth embodiment of a perineal trauma reduction device,

[0135] Figure 23 is a front view showing the female external reproductive organs during vaginal delivery of a fetus and the device according to the ninth embodiment during use,

[0136] Figure 24 is a perspective view of a tenth embodiment of a perineal trauma reduction device,

[0137] Figure 25 is a front view showing the female external reproductive organs during vaginal delivery of a fetus and the device according to the tenth embodiment during use.

[0138] Figure 26 is a front view of a perineal trauma reduction device according to an eleventh embodiment,

[0139] Figure 27 is a front view showing the female external genitalia during vaginal delivery of a fetus and the perineal trauma reduction device during use,

[0140] Figure 28 is a cross-sectional view of a female body and a perineal trauma reduction device in use during vaginal delivery of a fetus,

[0141] Figure 29 is a front view of a perineal trauma reduction device according to a twelfth embodiment,

[0142] Figure 30 is a front view showing the female external genitalia during vaginal delivery of a fetus and the perineal trauma reduction device during use,

[0143] Figure 31 is a cross-sectional view of a female body and a perineal trauma reduction device in use during vaginal delivery of a fetus,

[0144] Figure 32 is a front view of a perineal trauma reduction device according to a thirteenth embodiment,

[0145] Figure 33 is a front view showing the female external genitalia during vaginal delivery of a fetus and the perineal trauma reduction device during use,

[0146] Figure 34 is a cross-sectional view of a female body and a perineal trauma reduction device in use during vaginal delivery of a fetus,

[0147] Figure 35 is a front view of a perineal trauma reduction device according to a fourteenth embodiment,

[0148] Figure 36 is a front view showing the female external genitalia during vaginal delivery of a fetus and the perineal trauma reduction device during use,

[0149] Figure 37 is a cross-sectional view of a female body and a perineal trauma reduction device in use during vaginal delivery of a fetus,

[0150] Figure 38 is a front view of a perineal trauma reduction device according to a fifteenth embodiment,

[0151] Figure 39 is an angled profile view of a perineal trauma reduction device according to a sixteenth embodiment,

[0152] Figure 40 is a side view of the perineal trauma reduction device,

[0153] Figure 41 is a stereoscopic posterior view of the perineal trauma reduction device, and

[0154] Figure 42 are front and side views of a perineal trauma reduction device. DETAILED DESCRIPTION

[0155] First turn Figure 26 to Figure 4 4 is the embodiment shown.

[0156] Figure 26This is a front view of an eleventh embodiment of a perineal injury reduction device 1 for reducing injury during vaginal delivery of a fetus, the perineal injury reduction device being configured to be positioned outside a female body, on the perineum, the device 1 comprising: a second portion 20 formed of a sheet of flexible material; an inner surface configured to contact a surface of the female body; an outer surface opposite to the inner surface; at least one attachment element, preferably an adhesive, arranged at the inner surface and configured to be attached to the perineum; and two arms 22a, 22b and / or two legs 22c, 22d adapted to extend along the perineum away from the second portion 20 so as to support the perineum and reduce the rate of stretching of the perineum during vaginal delivery.

[0157] In the context of a patent application, a "sheet of flexible material" refers to a planar structure consisting of a pliable substance that can bend, deform, or adapt to different shapes. The term encompasses entities that are (geometrically) thin, substantially flat, and (mechanically) can be easily manipulated or molded. Examples of materials that conform to this specification include, but are not limited to, polymers, elastomers, fabrics, films, membranes, or any other similar flexible materials. The use of the term "sheet" does not necessarily imply a strict two-dimensional limitation, and may also encompass materials with a certain degree of thickness. The thickness may be variable and continuous. In this context, synonyms for "sheet" may include layer, membrane, film, panel, flat plate, plate, slat, or any other term for expressing a planar structure.

[0158] In an embodiment, the device is at least partially cast and / or injection molded.In an embodiment, the second portion and / or the first portion and / or the neck are at least partially cast and / or injection molded.

[0159] Figure 27 A front view is shown depicting the application of the perineal trauma reduction device 1 to a female body 51 before the fetus 52 passes through the vaginal opening 6. The second portion 20 is attached to the perineum between the posterior portion of the vaginal opening 6 and the anus 3 and is intended to protect this area during childbirth.

[0160] Various embodiments may feature different shapes and sizes of the second portion 20 to accommodate various factors, such as the anatomical variability of the female body 51, as illustrated in the different figures and embodiments presented.

[0161] As the fetus 52 advances through the vaginal opening 6, the length of the rear portion may double or triple, depending on the girth and head presentation position of the fetus 52. To accommodate these changes, the sheet material is constructed of an elastic material, thereby ensuring that the device stretches without damage.

[0162] Figure 28 A cross-sectional perspective view of a female body during vaginal delivery is shown with the perineal trauma reduction device properly positioned. The susceptibility to rupture (typically originating from the posterior side of the vaginal introitus 6) highlights the importance of shielding this area. The second portion 20 adheres to a substantial portion of the perineum, thereby ensuring all-around protection throughout the vaginal delivery process. In a specific embodiment, the second portion 20 has an elongated configuration characterized by being wider than it is tall. This design choice serves to extend coverage to a considerable area of ​​the perineum and adjacent areas, thereby enhancing the device's effectiveness in preventing potential complications during delivery.

[0163] In the following text, the same reference numerals are assigned to components serving the same function. The differences between them will be clarified in the description.

[0164] Figure 29 An embodiment of the perineal trauma reduction device 1 is shown, wherein the device 1 further comprises a first portion 10 formed of a flexible material and configured to be disposed inside the vagina, preferably via the vaginal entrance at a posterior portion of the vaginal entrance.

[0165] In an embodiment, the device 1 further comprises a neck portion 9 connected to the first portion 10 at one end and to the second portion 20 at an opposite end.

[0166] The device 1 is shown with the first portion 10 and the second portion 20 interconnected by a neck portion. It should be understood that throughout this specification, the terms "neck" and "bend" are used interchangeably to refer to this connecting element between the first and second portions. The neck / bend can take various configurations, such as being flat or curved.

[0167] When the neck is bent, the first and second portions extend at an angle A relative to each other, as in Figure 31 Better visible.

[0168] The designated angle A between the first and second portions 10, 20 significantly contributes to achieving an optimal fit for the device 1. Taking into account inherent physiological variations between individuals, angle A is designed to be adjustable, allowing for potential adjustments during childbirth. This adaptability ensures that the device can be adapted to different anatomical considerations. Furthermore, to accommodate the unique characteristics of each woman's body 51, a range of devices can be provided, each featuring a different angle and / or size of the first and second portions. This variety allows for personalized selection based on individual needs and ensures the device's effectiveness across a range of physiological differences.

[0169] In an embodiment, the second portion 20 is longer than the first portion 10. In an embodiment, the second portion extends further away from the bend than the first portion.

[0170] As in Figure 31 As can be seen above, the neck portion is flexible and / or is arranged with a bend so as to be able to extend from a second portion 20 arranged on the perineum over a rear portion of the vaginal entrance to a first portion 10 located inside the vagina in use.

[0171] In an embodiment, the angle of the bend and / or the angle between the first portion 10 and the second portion 20 is preferably in the range of 20 to 70 degrees, more preferably 30 to 60 degrees, more preferably 30 to 40 degrees.

[0172] In an embodiment, the first portion 10 is adapted to maintain the device 1 in place during childbirth.The first portion 10 is in contact with the posterior portion of the vaginal wall 8 (ie the portion closest to the anus 3).

[0173] The length of the first portion 10 can be adjusted for specific scenarios; a shorter first portion may be beneficial for later administration during vaginal delivery, while a longer first portion enhances contact with the vaginal wall 8, thereby ensuring better interaction between the female body 51 and the device 1. Both embodiments are preferred in view of different physiological considerations across different regions.

[0174] The vertical retention function allows the perineal cover to be expanded during childbirth to no more than 10 cm, preferably no more than 8 cm, and more preferably about 6 cm to 7 cm. This function is achieved by the synergistic interaction of internal fixation, the adhesive properties of the legs of the device, and the elasticity of the neck portion 9 to the legs via the second portion 20, as controlled by the geometry and elastic modulus.

[0175] The device's increased thickness in the vertical dimension enhances elasticity, providing greater resistance to plastic deformation. This structural design ensures the device's stability and effectiveness, significantly reducing the risk of perineal trauma by providing stable support and minimizing excessive and / or rapid stretching during childbirth. The device's adaptability meets diverse physiological conditions, adding an additional universal layer, making it ideal for diverse applications in different childbirth scenarios.

[0176] The device according to the twelfth embodiment comprises two arms 22a and 22b extending away from a central portion of the second portion 20 in generally opposite directions along the perineum.

[0177] As in Figure 30 As can be seen above, the two arms extend generally along the surface of the perineum, with this particular area of ​​the perineum overlying the transverse perineal muscle to provide perineal support.

[0178] In an embodiment, each arm extends toward the lateral border of the perineal triangle (medial thigh surface).

[0179] Steering Figures 32 to 34 , these figures show another embodiment of the invention in which two legs 22c, 22d extend along the perineum away from the second portion 20 on either side of the anus to provide perineal support to inhibit and / or reduce the rate of perineal stretching.

[0180] In an embodiment, each leg member extends toward the lower border of the perineal triangle (gluteal cleft).

[0181] In an embodiment, the device comprises two arm members 22a, b and two leg members 22c, d.

[0182] In an embodiment (not shown), the device includes a plurality of arm / leg members.

[0183] like Figure 33 As shown above, the second portion 20 is designed to match the typical distance between the vaginal opening 6 and the anus 3. However, taking into account the natural variation of anatomical dimensions between individuals, the device allows customization by cutting. If the distance is less than the average value, the device can be trimmed to have both the first portion 10 and the second portion 20 of equal length, or to have a shorter second portion 20. In addition, the design allows for the creation of a local recess in the middle section of the second portion, thereby adapting to specific anatomical changes. Cutting instructions (not depicted) can guide the customization process, thereby ensuring that the incision does not compromise the integrity of the reinforcing element. This adjustable feature emphasizes the versatility of the device, thereby making it suitable for a range of female body sizes and shapes without sacrificing its protective efficacy.

[0184] As from Figure 32 The size of the first part 10 shown is similar to Figure 35 As will be apparent from the variations in size shown, the components can be adjusted to accommodate specific anatomical variations. Figure 32 and Figure 35 As depicted, the variation in size of the second portion 20 highlights the adaptability of this portion to specific anatomical differences. This flexibility highlights the ability of the device to conform to different anatomies, thereby providing a tailored and effective solution for a range of individuals.

[0185] Likewise, the size (ie, width, height, and depth) of the neck 9 may vary between different embodiments.

[0186] The neck 9 of the device 1 is placed above the vaginal opening and inside the vagina, e.g. Figure 36 and Figure 37The neck provides protection and distributes pressure from small sharp angles over a larger surface (neck width).

[0187] The term "anchor" in the context of this application should be understood to refer to the first portion 10 and the neck 9, or just the first portion 9, depending on the description / embodiment. It should be understood that the first portion 10, with or without the neck 9, acts as a flexible anchor to hold the device in place and ensure retention from the outside to the inside of the vagina in order to prevent excessive upward stretching and elongation of the perineal wall.

[0188] In an embodiment, the first portion 10 is arranged between the vaginal wall and the baby's head so as to hold the first portion in place. Thus, a retention of the device from the inside of the vagina is provided.

[0189] Steering Figure 38 , which shows a preferred embodiment. Here, the device 1 further comprises an attachment element 34, preferably an adhesive, more preferably at least two layers of chemical adhesive, more preferably at least three layers of chemical adhesive. In another embodiment, the attachment element 34 is a pressure-sensitive adhesive, a tissue-specific glue, and / or a combination of these. This ensures reliable adhesion even in areas with hair.

[0190] The adhesive 34 partially covers the inner surfaces of at least the two arm members 22a, b and the two leg members 22c - d , as well as the elongated portion 20a of the inner surface of the second portion 20 .

[0191] Adhesive 34 provides for easy attachment of the device 1 to the exterior of a woman's body.

[0192] In an embodiment, the legs 22c, d and the elongated portion 20a provide vertical support and / or retention.

[0193] Throughout the delivery process, a covering mechanism (not shown) (such as a cover) may be provided to prevent accidental adhesion to other objects. In an embodiment, the cover comprises a separate element and / or may be divided into multiple sections by including perforations to allow the attachment element sections to be exposed independently.

[0194] For example, the elongated portion 20a of the second portion 20 can be revealed and attached to the female body, while the arm and leg pieces remain covered. This gradual exposure minimizes the risk of accidental attachment.

[0195] Once the device is securely positioned in the middle section, the covers on the side sections can be removed, facilitating attachment to the female body.Various sequences of administration are possible.

[0196] As in Figure 39 and Figure 40As best seen above, in embodiments, the first portion 10 comprises a preferably elongated protrusion 10a.

[0197] In an embodiment, the protrusion 10a has a half teardrop shape (as in Figure 40 visible in the side view).

[0198] The projection 10a helps the midwife to correctly position the anchor / first part 10, as the midwife can push the first part 10 between the baby's head and the vaginal wall by pushing the projection 10a, preferably with two fingers.

[0199] In an embodiment, the widest part of the device is the first portion, preferably the protrusion 10a portion of the first portion 10, as seen from the side view.

[0200] In an embodiment, the first portion has a depth greater than a depth of the second portion 20 .

[0201] These terms are commonly used to describe the three dimensions of an object, especially in geometric and physical descriptions. Height refers to the vertical dimension of an object, width refers to the horizontal dimension, and depth refers to the third dimension extending into the object. These concepts are fundamental to describing the properties of shape and space.

[0202] As in Figure 38 and Figure 39 As can be seen from the above, the shape of the second portion 20 not covered with adhesive can be varied according to different needs of consumers / users.

[0203] at last, Figure 42 An example of an embodiment of a perineal trauma reduction device according to the present invention is shown. Here, an exemplary version of the device is shown to illustrate an example of the size of the device. This is of course only an illustrative example and is not limiting in any way.

[0204] Seen in side view, the projection 10a and the first portion 10 have a combined width of 1 mm to 10 mm, preferably 3 mm to 7 mm, more preferably about 5 mm.

[0205] The width of the first portion 10 is 100 mm to 175 mm, preferably 125 mm to 150 mm, more preferably 130 mm to 140 mm, as viewed from the front.

[0206] The width of the neck 9 as viewed from the front is 10 mm to 75 mm, preferably 25 mm to 60 mm, more preferably 40 mm to 50 mm.

[0207] Now turn Figures 1 to 25 The embodiment shown.

[0208] Figure 1and Figure 2 FIG1 is a schematic diagram of a first embodiment of a perineal trauma reduction device 1 having a first portion 10 and a second portion 20. An inner surface 32 extends over the first portion 10 and the second portion 20, and an outer surface 33 is opposite the inner surface. Here, the inner surface 32 of the second portion 20 and the outer surface 33 of the first portion 10 face the viewer.

[0209] The inner surface 32, outer surface 33 and overall shape of the device are defined by a sheet of flexible material 7, which may be made, for example, of a thermoplastic elastomer. Here, the embodiment is shown in perspective so that the reinforcing elements 30a, 30b inside the device are visible, however this may not be the case in other embodiments.

[0210] The device 1 is shown in a state in which the first portion 10 and the second portion 20 meet at the bend 9 and extend at an angle A relative to each other, as in Figure 3 As can be better seen in FIG. 1 , the figure also shows that the second portion 20 can be longer than the first portion 10 .

[0211] exist Figure 3 In the embodiment, angle A is approximately 45 degrees, but other angle sizes may be advantageous depending on, for example, the materials used for the device 1, the configuration of the first part 10 and the second part 20, and the anatomy of the female body 51 on which the device is to be used.

[0212] The two reinforcing elements 30a, 30b extend from the first portion 10 into the middle section 21 of the second portion 20 and extend outwardly from there towards the side sections 22a, 22b of the second portion 20. The reinforcing elements 30a, 30b then extend rearwardly towards the middle section 21. This curved shape of the reinforcing elements 30a, 30b provides a large contact area between the sheet 7 and the reinforcing elements 30a, 30b, which provides stability to the device.

[0213] The reinforcing elements 30a, 30b are parallel to each other in the first portion 10 to reinforce a wide area of ​​the first portion 10. The reinforcing elements may also be interconnected at the first ends 31a, 31b (not shown) to form one reinforcing element.

[0214] In the figures, the reinforcing elements 30a, 30b are consistently shown as being flat, however they may have a rounded cross-sectional shape.

[0215] Figure 1 and Figure 2 The perineal trauma reduction device 1 in FIG. 1 includes recesses 91a, 91b at the curved portion 9. This may be advantageous in matching the shape of some female bodies.

[0216] The middle section 21 and the side sections 22a, 22b may be visually distinguishable, for example by Figure 2 A visual indication is provided at the dashed lines B in , or they may be indistinguishable.

[0217] Figure 4 is a schematic diagram illustrating the principle of a perineal trauma reduction device 1 that is applied to a female body 51 before a fetus 52 passes through the vaginal opening 6. The first portion 10 contacts the posterior portion of the vaginal wall 8 (i.e., the portion closest to the anus 3). The second portion 20 is attached to the area between the posterior portion of the vaginal opening 6 and the anus 3 to protect the area as the fetus passes through the vaginal opening 6. The angle A between the first portion 10 and the second portion 20 ensures a good fit of the device 1. Since physiology varies from person to person, the angle A can be adjustable and can be changed during delivery. Different devices with first and second portions of different angles and / or sizes can also be provided to select according to the individual female body 51.

[0218] In this embodiment, the first portion 10 is longer than the first portion 10 according to the first embodiment. For example, if the device is to be administered late in the course of vaginal delivery of the fetus, a shorter first portion 10 may be advantageous. However, a longer first portion 10 may provide a larger contact area between the first portion 10 and the vaginal wall 8 and may therefore provide better contact between the female body 51 and the device 1. Since physiology varies from country to country, both embodiments are preferred. In different embodiments, the first portion 10 may have different shapes and sizes, depending on, for example, the anatomical structure of the female body 51. In this embodiment, the first portion 10 has a rounded shape, however it may also have a more pointed shape, such as, for example Figure 10 shown.

[0219] exist Figure 4 In FIG, the first portion 10 is depicted as being in the correct position, however this may not be the initial position. The first portion 10 may have been attached to the second portion 20 or expanded (e.g., after the second portion 20 has been expanded). Figure 5 The inner surface 32 of the first portion 10 is smooth which will help to allow this repositioning, as will the reinforcing elements 30a, 30b.

[0220] Figure 5A schematic diagram of the female external genitalia is shown, including the urethral opening 2, anus 3, anal sphincter 4, fetus 52, and the perineal trauma reduction device 1 in use, wherein the second portion 20 covers the area between the vaginal opening and the anus 3 (also known as the perineum). The fetus 52 is in the process of passing through the vaginal opening 6, and therefore, the length of the posterior portion of the vaginal opening 6 may become two or three times, depending on the girth of the fetus 52 and the presenting position of the fetal head. For this reason, the sheet can be made of an elastic material to ensure that the device does not break when stretched. Reinforcement elements 30a, 30b provide additional stability to the device.

[0221] The rupture usually begins at the posterior portion of the vaginal opening 6, which is why it is important to protect this area. The second portion 20 is adhered to at least a portion of the perineum to provide good protection to this area throughout the vaginal delivery of the fetus. Figure 5 It is not visible in the vagina because it is located in the vagina, such as Figure 4 The second portion 20 is wider than the first portion 10 so that the device can fit into the vaginal opening while still covering a large area of ​​the perineum and adjacent areas.

[0222] exist Figure 5 In the embodiment, the second portion 20 has a size that matches the distance between the vaginal opening 6 and the anus 3. However, if this distance is less than average, the device can be cut so that the first and second portions 10, 20 are equal in length, or so that the second portion 20 is shorter than the first portion 10. A localized recess can also be cut in the middle section of the second portion. Cutting instructions (not shown) can be provided to ensure that the cut does not affect the reinforcing element.

[0223] In the following, the same reference numerals are used for components sharing the same function. Only the differences will be described.

[0224] Figure 6 and Figure 7 Shown with Figure 1 An embodiment similar to the embodiment in Figure 6 In the embodiment, the first ends 31a, 31b of the reinforcing elements 30a, 30b extend towards each other in the first portion 10 and Figure 7 In the embodiment shown in FIG. 1 , the first ends 31 a , 31 b of the reinforcing elements 30 a , 30 b extend away from each other in the first portion 10 . Figure 6 The embodiment in provides a particularly strong reinforcement at the center of the first portion, while Figure 7 The embodiment in can ensure that the side of the first part 10 will not collapse.

[0225] Figure 8 and Figure 9 Also shown with Figure 1, but here, the reinforcing elements 30a, 30b do not extend rearwardly toward the middle section 21. In these embodiments, the reinforcing elements 30a, 30b are shorter than in the previously described embodiments and have a smaller contact area with the sheet 7. This may be advantageous if the device 1 needs to be cut to fit the size of a petite female body.

[0226] Figure 10 Another embodiment is shown in FIG. Here, the sheet 7 has a butterfly shape to cover the area adjacent to the anus 3 and extending upward along the side of the vaginal opening. This may provide greater protection for the perineum because the second portion 20 covers a larger part of the perineum without covering the anus, which is also in the Figure 11 As shown in FIG. , the force is thus distributed over a larger area, thereby reducing the risk of injury to the perineum. Attaching the second part 20 completely or partially to the anus 3 can be uncomfortable for the woman and, due to different tissue types and body fluids, can impair the attachment, which is why this should be avoided. In this embodiment, the reinforcing element is not visible but is present inside the sheet 7.

[0227] Figure 12 Shown in side view Figure 11 , wherein the side segments 22 a, 22 b extend beyond the bend 9 .

[0228] exist Figure 13 In the embodiment, the side segments 22a, 22b extend beyond the bend to a lesser extent than Figure 12 The first part 10 is more Figure 12 The length of the middle.

[0229] Figure 14 1 is a schematic diagram showing the principle of the perineal trauma reduction device 1 in use. In this embodiment, the first portion 10 is shorter than the second portion 20, and the side sections 22a, 22b extend beyond the anus 3. It should be understood that the second portion does not cover the anus, but rather is in contact with the anus. Figure 11 Alternatively, the first portion 10 may be longer, as in Figure 15 Embodiments in which the device does not extend below the anus are also possible, such as Figure 16 As shown, in principle corresponds to Figure 5 The situation in .

[0230] Figure 17 The perineal trauma reduction device 1 is depicted, wherein the first portion 10 is longer than in the previously described embodiment and has a curvature in the delivery position. The first portion 10 is thicker at the ends and sides than in the middle section. This can facilitate insertion into the vaginal opening.

[0231] Figure 18 and Figure 19 Another embodiment is shown in which the first portion 10 has a Figure 17 The curved shape shown is slightly shorter, and the second portion 20 is also shorter than Figure 17 For example, if the female body is smaller than average, this embodiment may be advantageous. Figure 1 and Figure 2 Compared with the implementation scheme in Figure 18 The embodiment in has no recess at the bend 9. This may provide strength advantages.

[0232] Figures 20 to 25 , which illustrate possible variations in the size and shape of the first and second portions 10, 20. It should be understood that these are merely examples and that further variations and combinations are within the scope of the present invention.

[0233] In the context of the present invention, it is emphasized that the embodiments shown in the accompanying drawings are exemplary in nature and serve as a demonstration of various potential configurations of perineal trauma reduction devices. These embodiments are not intended to be exhaustive or limiting, and the scope of the invention encompasses a wider range of variations and combinations that are not explicitly depicted. Therefore, these embodiments are provided for illustrative purposes only, and the present invention should not be construed as limited to the specific structural or functional features shown in any single figure. It is expressly stated that any additional variation, modification or combination of features, whether or not explicitly described, falls within the scope of the invention as defined by the appended claims. This interpretative flexibility is designed to ensure that the present invention covers the full range of potential embodiments, thereby allowing innovation and adaptation in response to specific application requirements or technological advances.

[0234] Another embodiment of the present invention:

[0235] In an embodiment, a perineal trauma reduction device for reducing trauma during vaginal delivery of a fetus is provided. The device comprises:

[0236] a first portion configured to be inserted into a female body via a vaginal entrance at a posterior portion of the vaginal entrance, and

[0237] a second portion configured to extend outside the female body away from the rear portion of the vaginal entrance toward the anus,

[0238] an inner surface extending over the first portion and the second portion and configured to contact a surface of a female body,

[0239] an outer surface, the outer surface being opposite to the inner surface,

[0240] The inner surface and the outer surface are formed from a sheet of flexible material, and

[0241] The perineal trauma reduction device further comprises at least one reinforcing element for stabilizing the sheet,

[0242] in,

[0243] the at least one reinforcing element extending over both said first portion and said second portion,

[0244] and characterized in that the second portion includes at least one attachment element at an inner surface, the at least one attachment element being configured for attachment to a surface of the female body.

[0245] In embodiments, the inner surface of the first portion comprises a smooth surface.

[0246] In an embodiment, the second portion comprises a middle section and two side sections, and wherein the at least one reinforcing element extends through the middle section and outwardly towards the edges of said side sections.

[0247] In embodiments, the at least one reinforcing element extends further inwardly rearwardly towards the middle section of the second portion.

[0248] In an embodiment, the first portion and the second portion meet at a bend and extend at an angle relative to each other, the angle preferably being in the range of 20 to 70 degrees, more preferably 30 to 60 degrees, more preferably 30 to 40 degrees.

[0249] In an embodiment, in the delivery position, the device is pre-shaped with the bend between the first portion and the second portion.

[0250] In an embodiment, the sheet of flexible material has a thickening at the bend.

[0251] In an embodiment, the at least one reinforcing element is elastic, thereby pulling the device towards the delivery position.

[0252] In an embodiment, the reinforcing element has a higher stiffness than the sheet.

[0253] In an embodiment, the reinforcing element is embedded in the sheet of flexible material between said inner surface and said outer surface.

[0254] In an embodiment, the attachment element comprises an adhesive.

[0255] In an embodiment, the perineal trauma reduction device comprises a thickness of 0.1 mm to 10 mm, more preferably 0.5 mm to 5 mm.

[0256] In an embodiment, a method for reducing trauma during vaginal delivery of a fetus, the method comprising:

[0257] A perineal trauma reduction device is provided comprising a first portion and a second portion, wherein a sheet of flexible material defines an inner surface and an outer surface opposite the inner surface, the inner surface extending over the first portion and the second portion, and wherein at least one reinforcing element extends over both the first portion and the second portion and stabilizes the sheet,

[0258] arranging the perineal trauma reduction device wherein the first portion is inserted into the female body via the vaginal entrance at a posterior portion of the vaginal entrance, and wherein the second portion extends outside the female body away from the posterior portion of the vaginal entrance toward the anus with the inner surface in contact with a surface of the female body, and

[0259] The second portion is attached to a surface of the female body between the posterior portion of the vaginal entrance and the anus using at least one attachment element at the inner surface.

[0260] In an embodiment, the perineal trauma reduction device is bent prior to being positioned on the female body such that the first portion and the second portion extend at an angle relative to each other.

[0261] 1 Device 2 urethral opening 3 anus 4 anal sphincter 51 female body 52 fetus 6 vaginal opening 7 Flexible material sheet 8 vaginal wall 9 Bend / neck 91a concavity 91b concavity 10 Part 1 20 Part 2 21 middle section 22a Side section 22b Side section 30a Reinforcement components 30b Reinforcement components 31a The first end of the reinforcing element 30a 31b The first end of the reinforcing element 30b 32 inner surface 33 outer surface 34 Attachment element (preferably adhesive) A Angle between the first portion 10 and the second portion 20 B Visual indicator line

Claims

1. A perineal trauma reduction device 1 for reducing trauma during vaginal delivery of a fetus, the perineal trauma reduction device being configured to be positioned externally on a female body, on the perineum, the device 1 comprising: a second portion 20 formed from a sheet of flexible material, - an inner surface configured to come into contact with a surface of the female body, - an outer surface, opposite to said inner surface, at least one attachment element 34 , preferably an adhesive, arranged at the inner surface, configured for attachment to the perineum, and - two arms 22a, 22b and / or two legs 22c, 22d adapted to extend along the perineum away from the second portion 20 in order to support said perineum during vaginal delivery.

2. The perineal injury reduction device 1 according to claim 1, wherein: The device 1 further comprises a first portion 10 formed of a flexible material and configured to be arranged inside the vagina via the vaginal entrance at a posterior portion of the vaginal entrance.

3. The perineal injury reduction device 1 according to any one of claims 1 or 2, wherein: The device 1 further comprises a neck portion 9 connected to the first portion 10 at one end and to the second portion 20 at an opposite end.

4. The perineal injury reduction device 1 according to claim 3, wherein: The neck portion is bendable and / or arranged with a bend so as to extend, in use, from the second portion 20 arranged on the perineum, across the rear portion of the vaginal entrance, to the first portion 10 located inside the vagina.

5. The perineal injury reduction device 1 according to claim 4, wherein: The angle of the bend and / or the angle between the first portion 10 and the second portion 20 is preferably in the range of 20 to 70 degrees, more preferably 30 to 60 degrees, more preferably 30 to 40 degrees.

6. The perineal damage reduction device 1 according to any one of claims 2 to 5, wherein: The first portion 10 is adapted to maintain the device 1 in place during childbirth.

7. The perineal damage reduction device 1 according to any one of claims 2 to 6, wherein: The first portion 10 comprises an elongated shape adapted to extend across the interior of the vagina, preferably adjacent the posterior vaginal entrance.

8. The perineal trauma reduction device 1 according to any one of the preceding claims, wherein: The two arms 22a, 22b extend away from the second portion 20 in generally opposite directions along the perineum, and more particularly generally along the surface of the perineum overlying the transverse perineum muscle, so as to provide perineal support.

9. The perineal trauma reduction device 1 according to any one of the preceding claims, wherein: Two legs 22c, 22d extend along the perineum away from the second portion 20 on each side of the anus to provide perineal support.

10. The perineal trauma reduction device 1 according to any one of the preceding claims, the device 1 having a thickness of 0.1 to 10 mm, more preferably 0.5 to 5 mm.

11. The perineal trauma reduction device 1 according to any one of the preceding claims, wherein: The attachment element 34, preferably adhesive, covers: the inner surface of at least two arms 22a, b and / or two legs 22c-d, and / or A portion of the inner surface of the second portion 20, The device 1 is thereby attached to an external area of ​​the body.

12. A method for reducing trauma, preferably to the perineum, during vaginal delivery of a fetus, the method comprising: - providing a perineal trauma reduction device 1 comprising a first portion 10, a second portion 20, and a neck portion 9 connecting the first and second portions, wherein an inner surface and an outer surface opposite the inner surface are provided, and wherein at least one attachment element 34, preferably an adhesive, extends partially on the inner surface of the second portion, - placing the perineal trauma reduction device on a female body, wherein the first portion 10 is located at the posterior portion of the vaginal entrance, and wherein the second portion 20 extends along the perineum, such that the attachment element arranged on the inner surface contacts the surface of the female body, and - attaching the second portion 20 to said surface of the female body using said at least one attachment element.

13. The method according to claim 12, wherein: The perineal trauma reduction device 1 is bent at the neck portion 9 when arranged on the female body so that the first portion and the second portion extend at an angle relative to each other.

14. The method according to any one of claims 12 to 13, wherein Before the first portion is arranged in the vagina, the opposite ends of the first portion 10 are bent towards each other, preferably to obtain a generally U-shape.

15. The method according to any one of claims 12 to 14, wherein The device is arranged such that in use during vaginal delivery, the device 1 is further held in place because the force exerted by the fetal head on the first portion 10 maintains the device in place.

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