Perineal trauma reduction device and method for reducing trauma during vaginal birth of a child

Abstract

A perineal injury reduction device for reducing injury during vaginal birth of a child is disclosed. It comprises a first portion configured to be inserted into a woman's body through the vaginal introitus at a posterior portion of the vaginal introitus and a second portion configured to extend from the posterior portion of the vaginal introitus toward the anus and outward from the woman's body. The device comprises a sheet of flexible material and at least one reinforcing element stabilizing the sheet and extending across both the first and second portions. The second portion further comprises at least one attachment element on an interior surface configured to attach to a surface of the woman's body. In one embodiment, the first and second portions meet at a bend and extend at an angle relative to each other in a birthing position. A method for reducing injury during vaginal birth of a child is also disclosed.

Description

[Technical Field]

[0001] The present invention relates to a perineal injury reduction device for reducing injury during vaginal birth of a child, the perineal injury reduction device comprising a first portion configured to be inserted into a woman's body through the vaginal introitus at a posterior portion of the vaginal introitus and a second portion configured to extend outside the woman's body away from the posterior portion of the vaginal introitus towards the anus, an inner surface extending across the first and second portions and configured to contact a surface of the woman's body, an outer surface opposite the inner surface, the inner surface and the outer surface being formed by a sheet of flexible material, the perineal injury reduction device further comprising at least one reinforcing element for stabilizing the sheet. The present invention further relates to a method for reducing trauma during vaginal delivery of a child. [Background technology]

[0002] Injury to the perineum, the area between the vaginal opening and the anus, is a common complication after vaginal birth and can cause long-term discomfort. Injury to the perineum can occur in the form of perineal tears, which are tears in the skin and other soft tissue structures that separate the vagina from the anus in women. Tears often begin posterior to the vaginal introitus, the area of ​​the vaginal opening closest to the anus and the rear of the body. While all tears cause discomfort, more severe tears involving the anal or urethral sphincter can cause incontinence.

[0003] Up to 9 in 10 first-time mothers who deliver their children vaginally will have some type of perineal injury, making it the most common form of obstetric trauma. Even if sphincter injuries are detected and sutured immediately after delivery, up to 50% of patients will experience fecal or urinary incontinence, pain, or sexual dysfunction at some point. These complications can have significant consequences on a woman's quality of life.

[0004] Perineal protection during vaginal birth of a child can be achieved manually by a health care provider, usually a midwife, who places their thumb and index finger along the vaginal opening, also called the introitus, to support the perineum, however, many of them, especially in developing countries, do not receive proper training.

[0005] Therefore, attempts have been made to provide such devices to reduce the number of tears and protect the perineum during vaginal birth of a child. Such a device is known from WO09101186A1. This device is specifically adapted to protect the tissues at the posterior part of the vaginal introitus and works very well, but requires the involvement of trained medical personnel. Summary of the Invention

[0006] It is therefore an object of the present invention to provide an alternative device that can be handled by unskilled birth helpers.

[0007] According to one aspect of the present invention, this and further objects are achieved by a device as described above, further comprising at least one reinforcing element extending across both the first portion and the second portion, the second portion comprising at least one attachment element on an inner surface thereof configured for attachment to the surface of a female body.

[0008] The combination of attachment and reinforcing elements extending across both the first and second sections facilitates handling of the perineal trauma reduction device, ensuring that the device is accurately positioned and stays in place during use. Only the second section needs to be attached to the woman's body. The reinforcing elements extending within the first section ensure that the positioning of the second section results in the first section being positioned along the vaginal wall at the posterior of the vaginal opening. This means that an inexperienced birth assistant only needs to ensure that the second section is properly attached. This is particularly advantageous because it can be difficult to see the first section once inserted and therefore difficult to know whether it is correctly positioned. This means that the device can be applied by inexperienced birth assistants, such as those in developing countries, who often have no or only very basic training and therefore may rely on application instructions, such as illustrations or app instructions. This device may be particularly useful for inexperienced birth assistants, but may also be useful for trained birth assistants, such as health care workers, midwives, and doctors.

[0009] A reinforcing element extending across both the first and second portions can also cause the first portion to reposition as a result of a change in shape of the second portion. During vaginal delivery of a child, the vaginal opening dilates, causing the adjacent area to also dilate, which can cause the second portion to 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 vaginal delivery of a child, such that the first portion remains in contact with the vaginal wall even when not attached to the vaginal wall.

[0010] The at least one attachment element further ensures that the device remains attached to the woman's body during the entire use.

[0011] A further advantage of the present invention is that the perineal trauma reduction device provides protection through distribution of perineal tension over a wide surface area, not only in the area where the second portion is attached, but also through the first portion to the vaginal wall. Additionally, the device may slow perineal distension time, thus minimizing the risk of laceration.

[0012] Providing at least one reinforcing element that extends across both the first and second portions also contributes to easier handling and positioning of the device for untrained birthing helpers. The reinforcing element that extends across both portions provides stability and prevents the device from sticking together or twisting.

[0013] In a preferred embodiment, the sheet of flexible material is elastic. Elasticity refers to the resilience of a material, which is the tendency of a solid material to return to its original shape after a force is applied to it. This is advantageous when the vaginal introitus expands, causing adjacent surfaces to also expand. When expanded, the sheet thereby attempts to return to its original shape, thereby resisting perineal expansion.

[0014] In one embodiment, the flexible sheet may be capable of expanding to two or three times its size.

[0015] In one embodiment, the inner surface of the first part includes a smooth surface. The smooth surface comprises a non-adhesive surface. The smooth surface can facilitate handling of the device because the first part does not stick to unwanted locations. This is particularly useful if the first part is initially positioned incorrectly, which can often occur with inexperienced birth helpers because the first part may not be visible due to its position in the vagina. Once the second part is attached to the surface of the woman's body, the first part can then be freely repositioned and fall into place as described above.

[0016] In one embodiment, only the second portion comprises the attachment element.

[0017] In one embodiment, the second portion comprises two side sections and a central section, with at least one reinforcing element extending through the central section and outward toward the edges of the side sections. Providing a reinforcing element that extends across a large area of ​​the device makes the device stable and easy to handle. This also ensures good force transmission from the second portion to the first portion, since there is a large contact area between the reinforcing element and the seat. The large reinforcing element also allows for good force transmission between the device and the woman's body.

[0018] At least one reinforcing element may comprise two sections extending from a first portion to a second portion, said sections being interconnected at the first portion. The reinforcing element may extend into both side sections.

[0019] It is also possible to provide two or more separate reinforcing elements, each extending across both the first and second portions, with one reinforcing element extending into one side section and another reinforcing element extending into the other side section.

[0020] In one embodiment, at least one reinforcing element further extends back inward toward the central section of the second portion. The section of the reinforcing element extending into the second portion may have a rounded shape, preferably a U-shape. This may further stabilize the device since there is a relatively large contact area between the reinforcing element and the sheet.

[0021] The reinforcing elements preferably do not have sharp edges to avoid damage to the sheet.

[0022] In one embodiment, the first and second portions meet at a bend and extend at an angle relative to one another, the angle preferably ranging from 20 to 70 degrees, more preferably from 30 to 60 degrees, more preferably from 30 to 40 degrees. These angles have proven useful as they fit the average female anatomy particularly well and the angle helps to facilitate accurate placement of the device, which stays in place during use.

[0023] In one embodiment, in the delivery position, the device is pre-formed with a bend between the first and second portions. The delivery position refers to the state of the device when the user holds the device, including the state of the device when applying the device to the body. Pre-formed indicates that the device is formed in a ready-to-use state in the delivery position. The ready-to-use state further facilitates handling of the device, as the device may already conform to the anatomy of the female body and may not require further bending.

[0024] Pre-forming does not limit the device to one shape: a pre-formed device can still be adjusted.

[0025] In one embodiment, the sheet of flexible material has a thickened portion at the bend. The thickened portion at the bend is intended to maintain the intended angle between the first and second portions, thus preventing the device from collapsing. However, the thickness should allow for some repositioning of the first and second portions relative to each other during use, for example, as a result of a child pushing on the first portion.

[0026] In one embodiment, at least one reinforcing element is elastic and pulls the device toward the delivery position. This may contribute to the device's ability to adapt to changes in the shape of the woman's body during delivery, such as the dilation of the vaginal opening during the passage of the baby. The elasticity of the reinforcing element also reduces the risk of breakage, which could result in the formation of sharp edges.

[0027] The reinforcing elements may comprise a different material or may comprise the same material as the sheet. If the reinforcing elements comprise the same material as the sheet, the material of the reinforcing elements may have a higher density or compactness.

[0028] The reinforcing element may comprise a polymeric material such as an elastomer, a thermoplastic elastomer, a Mediprene thermoplastic elastomer, nylon, polypropylene, polyethylene, polyurethane, polycarbonate, vinyl, polytetrafluoroethylene, silicone, or a woven fabric.

[0029] In one embodiment, the reinforcing element may comprise a non-polymeric material, such as a metallic material.

[0030] In one embodiment, the reinforcing element has a higher stiffness than the sheet. This allows the reinforcing element to reinforce the device, thereby facilitating handling of the device. Stiffness refers to the degree to which an object resists deformation in response to an applied force. Stiffness ensures a stable reinforcing element.

[0031] In one embodiment, the reinforcing elements are embedded in the sheet of flexible material between the inner and outer surfaces. This may make the device easier to handle and may reduce the risk of any unintentional injury to the mother, the baby, or untrained birth helpers caused by the reinforcing elements. For the same reason, the reinforcing elements preferably do not have sharp edges.

[0032] If the reinforcing element is not covered by a sheet element, the reinforcing element should preferably be biocompatible.

[0033] In a preferred embodiment, the sheet of flexible material comprises a polymeric material such as an elastomer, a thermoplastic elastomer, a Mediprene thermoplastic elastomer, nylon, polypropylene, polyethylene, polyurethane, polycarbonate, vinyl, polytetrafluoroethylene, silicone, or a woven fabric.

[0034] In one embodiment, the sheet of flexible material may comprise a non-polymeric material.

[0035] A flexible material refers to a material that has the ability to easily bend or compress under normal conditions without cracking. Flexible materials allow the device to conform to different shapes, which is advantageous in dynamic environments such as during vaginal delivery of a child.

[0036] The sheet of flexible material may comprise one or more layers of the same or different materials.

[0037] In one embodiment, the sheet of flexible material comprises a transparent material that may allow the user to continuously inspect the underlying tissue during application of the device and / or during vaginal delivery of the child.

[0038] 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 an advantage, as fluids can impair adhesion. This feature also protects the skin from any potential damage, as prolonged exposure to liquids can damage the skin. The perforations also allow an untrained birthing helper to inspect the skin through the perforations, which is useful if the sheet is opaque.

[0039] The exterior surface of the first portion may be smooth, at least when wet, having low friction resistance against human skin and hair, which can help a child slide on the device.

[0040] The material of the flexible sheet must be biocompatible and must not cause an allergic reaction, for this reason latex or similar allergenic materials may be less preferred.

[0041] The sheet of flexible material may be cuttable, allowing it to be cut to size. This is useful if the area between the posterior vaginal opening 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.

[0042] In one embodiment, the attachment element comprises an adhesive, which helps the device stay in place during use.

[0043] The attachment elements may be provided on the sheet of flexible material forming the second portion or may be integral to the second portion. The attachment elements on the inner surface of the second portion may be provided such that the inner surface of the second portion is self-adhering or the attachment elements are provided on the inner surface. The attachment elements are made of a material that will adhere to a female body surface, preferably a material that will adhere to a body surface covered with bodily fluids such as vaginal secretions.

[0044] The separate attachment element may comprise an adhesive such as a pressure sensitive adhesive or glue, e.g., a tissue specific glue. The attachment element may advantageously be able to adhere to the location where the hair emerges to ensure good adhesion.

[0045] In one embodiment, only the inner surface of the second portion comprises the attachment elements.

[0046] The attachment elements may be covered by a cover in the birthing condition, which may prevent the device from being unintentionally attached to other items, such as other perineal trauma reduction devices.

[0047] The cover may comprise several separate elements or may be divided into two or more sections, for example by perforations, so that sections of the attachment elements are not independently covered. This allows, for example, a second part comprising a central section and two side sections as described above, with the central section exposed and attached to the woman's body, while the side sections remain covered. This allows the device to be applied while some of the attachment elements remain covered, thus reducing the risk of unintentional attachment. Once the device is placed and attached to the central section, the covers of the side sections can be removed and the side sections can be attached to the woman's body. Other application sequences are also possible.

[0048] In one 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 may be selected based on functionality and user acceptance; i.e., the device may function from a technical standpoint at a thickness of up to 0.1 mm, but may be thicker to accommodate user perception and acceptance.

[0049] In one embodiment, the second portion is thicker than the first portion.

[0050] In one embodiment, the first portion is thicker than the second portion.

[0051] The thickness of the first and / or second portions may vary. For example, the second portion may be thicker or thinner in the center section compared to the side sections to provide desired physical characteristics, or the edges of the second portion may be thinner than the remainder to facilitate attachment or removal. As another example, the edges of the first portion may be thinner and more flexible than the center section, thereby potentially facilitating insertion or providing the first portion with a shape that conforms to the shape of the vaginal wall.

[0052] A second aspect of the present invention relates to a method for reducing injury during vaginal birth of a child, the method comprising providing a perineal injury reduction device comprising a first part and a second part; a sheet of flexible material defining an inner surface and an outer surface opposite the inner surface, the inner surface extending across the first part and the second part, at least one reinforcing element extending across both the first part and the second part and stabilizing the sheet; positioning the perineal injury reduction device so that the first part is inserted through the vaginal introitus into a female body at a posterior vaginal introitus and the second part extends outside the female body from the posterior vaginal introitus towards the anus, the inner surface contacting a surface of the female body; and attaching the second part to a surface of the female body between the posterior vaginal introitus and the anus using at least one attachment element on the inner surface.

[0053] Embodiments and advantages described with reference to one aspect of the invention also apply to the other aspects unless stated otherwise. By way of 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 the present method. [Brief explanation of the drawings]

[0054] In the following description, embodiments of the present invention will be described with reference to the figures. [Figure 1] FIG. 1 illustrates a perspective view of a first embodiment of a perineal trauma reduction device. [Figure 2] FIG. 2 is a front view of the device according to the first embodiment. [Figure 3] FIG. 3 is a side view of the device according to the first embodiment. [Figure 4] FIG. 4 is a cross-sectional view of a woman's body and a perineal trauma reduction device used during vaginal delivery of a baby. [Figure 5] FIG. 5 is a front view showing the external female genitalia during vaginal delivery of a child and the perineal trauma reduction device in use. [Figure 6]FIG. 1 is a perspective view of a second embodiment of a perineal trauma reduction device. [Figure 7] FIG. 7 is a perspective view of a third embodiment of a perineal trauma reduction device. [Figure 8] FIG. 8 is a perspective view of a fourth embodiment of a perineal trauma reduction device. [Figure 9] FIG. 9 is a perspective view of a fifth embodiment of a perineal trauma reduction device. [Figure 10] FIG. 10 is a perspective view of a sixth embodiment of a perineal trauma reduction device. [Figure 11] FIG. 11 is a front view showing the external female genitalia during vaginal delivery of a child and a perineal trauma reduction device in use. [Figure 12] FIG. 12 is a side view of a device according to a sixth embodiment of a perineal trauma reduction device. [Figure 13] FIG. 13 is a side view of a perineal trauma reduction device. [Figure 14] FIG. 14 is a cross-sectional view of a woman's body and a perineal trauma reduction device used during vaginal delivery of a baby. [Figure 15] FIG. 15 is a cross-sectional view of a woman's body and a perineal trauma reduction device used during vaginal delivery of a baby. [Figure 16] FIG. 16 is a cross-sectional view of a woman's body and a perineal trauma reduction device used during vaginal delivery of a baby. [Figure 17] FIG. 17 is a perspective view of a seventh embodiment of a perineal trauma reduction device. [Figure 18] FIG. 18 is a perspective view of an eighth embodiment of a perineal trauma reduction device. [Figure 19] FIG. 19 is a side view of a device according to an eighth embodiment of a perineal trauma reduction device. [Figure 20] FIG. 20 is a front view of a perineal trauma reduction device. [Figure 21] FIG. 21 is a front view of a perineal trauma reduction device. [Figure 22] FIG. 22 is a perspective view of a ninth embodiment of a perineal trauma reduction device. [Figure 23] FIG. 23 is a front view showing the external female genitalia during vaginal delivery of a child and a device according to the ninth embodiment in use. [Figure 24] FIG. 24 is a perspective view of a tenth embodiment of a perineal trauma reduction device. [Figure 25] FIG. 25 is a front view showing the external female genitalia during vaginal delivery of a child and a device according to the tenth embodiment in use. DETAILED DESCRIPTION OF THE INVENTION

[0055] 1 and 2 are perspective views 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 across the first portion 10 and the second portion 20, and an outer surface 33 is opposite the inner surface, where the inner surface 32 of the second portion 20 and the outer surface 33 of the first portion 10 face the viewer.

[0056] 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 from, for example, a thermoplastic elastomer. Here, the embodiment is shown as see-through so that the reinforcing elements 30a, 30b inside the device are visible, although this may not be the case in other embodiments.

[0057] Device 1 is shown with first portion 10 and second portion 20 meeting at bend 9 and extending at angle A relative to each other as better seen in FIG. 3, which also shows that second portion 20 may be longer than first portion 10.

[0058] In FIG. 3, angle A is approximately 45 degrees, although other angle sizes may be advantageous depending, for example, on the material used in device 1, the configuration of first portion 10 and second portion 20, and the anatomical structure of the female body 51 in which the device is to be used.

[0059] Two reinforcing elements 30a, 30b extend from first portion 10 into central section 21 of second portion 20, and from there extend outward toward side sections 22a, 22b of second portion 20. Reinforcing elements 30a, 30b then extend backward toward central section 21. This curved shape of reinforcing elements 30a, 30b provides a large contact area between sheet 7 and reinforcing elements 30a, 30b, which provides stability to the device.

[0060] The reinforcing elements 30a, 30b are parallel to each other within the first portion 10 to reinforce a large area of ​​the first portion 10. The reinforcing elements may also be interconnected at first ends 31a, 31b (not shown), thereby forming one reinforcing element.

[0061] Although in the drawings the reinforcing elements 30a, 30b are shown as being consistently flat, they may also have a rounded cross-sectional shape.

[0062] The perineal trauma reduction device 1 of Figures 1 and 2 includes recesses 91a, 91b in the bend 9. This can be advantageous for adapting to the shape of some women's bodies.

[0063] The central section 21 and side sections 22a, 22b may or may not be visually distinguishable, for example, by providing a visual indication at dashed line B in FIG.

[0064] FIG. 4 is a principle diagram depicting the perineal trauma reduction device 1 applied to a woman's body 51 before a baby 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 this area as the baby 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. Because physiology varies from person to person, the angle A is adaptable and may change during the delivery of the baby. Different devices with different angles and / or sizes of the first and second portions may also be provided to be selected according to the individual woman's body 51.

[0065] In this embodiment, the first portion 10 is longer than the first portion 10 of the first embodiment. A shorter first portion 10 may be advantageous, for example, when the device is applied during the later stages of vaginal childbirth. However, a longer first portion 10 may provide a larger contact area between the first portion 10 and the vaginal wall 8, and thus better contact between the female body 51 and the device 1. Because physiology varies from country to country, both embodiments are preferred. The first portion 10 may have different shapes and sizes in different embodiments, for example, depending on the anatomical structure of the female body 51. In this embodiment, the first portion 10 has a rounded shape, but it may also have a more pointed shape, as shown in FIG. 10 .

[0066] In Figure 4, the first part 10 is shown in the correct position, but this need not be the initial position. The first part 10 may be repositioned to the correct position after attachment of the second part 20, or after expansion of the second part 20 as shown in Figure 5, where the head of the child 52 has passed through the vaginal opening. The smoothness of the inner surface 32 of the first part 10 contributes to allowing repositioning of the reinforcing elements 30a, 30b.

[0067] FIG. 5 shows a schematic representation of the main external female genitalia, including the urethral meatus 2, anus 3, anal sphincter 4, baby 52, and perineal trauma reduction device 1 in use, with second portion 20 covering the area between the vaginal opening and anus 3, also known as the perineum. Baby 52 is in the process of passing through vaginal opening 6, so that the length of the portion posterior to the vaginal opening 6 can be doubled or tripled depending on the circumference of baby 52 and the presentation of the baby's head. For this reason, the sheet may be made from an elastic material to ensure that the device does not break when stretched. Reinforcing elements 30a, 30b provide additional stability to the device.

[0068] Tears often begin posterior to the vaginal opening 6, which is why protecting this area is important. Second portion 20 adheres to at least a portion of the perineum to provide good protection to this area throughout the vaginal delivery of the child. First portion 10 is not visible in FIG. 5 because it is located in the vagina as shown in FIG. 4. Second portion 20 is wider than first portion 10, so that the device can conform to the vaginal opening while still covering a large area of ​​the perineum and adjacent areas.

[0069] In Figure 5, the second part 20 has a size that corresponds to the distance between the vaginal opening 6 and the anus 3. However, if this distance is smaller than average, the device can be cut so that the first and second parts 10 and 20 are of equal length, or so that the second part 20 is shorter than the first part 10. It is also possible to cut a localized recess in the central section of the second part. Cutting indicators (not shown) may be provided to ensure that the cut does not affect the reinforcing element.

[0070] In the following description, parts sharing the same functionality will use the same reference numerals, and only the differences will be described.

[0071] Figures 6 and 7 show an embodiment similar to that of Figure 1, but in Figure 6 the first ends 31 a, 31 b of the reinforcing elements 30 a, 30 b extend towards each other within the first part 10, and in Figure 7 the first ends 31 a, 31 b of the reinforcing elements 30 a, 30 b extend away from each other within the first part 10. The embodiment of Figure 6 provides particularly strong reinforcement in the centre of the first part, while the embodiment of Figure 7 can ensure that the sides of the first part 10 do not collapse.

[0072] 8 and 9 also show an embodiment similar to that of FIG. 1, but here the reinforcing elements 30a, 30b do not extend rearward towards the central section 21. In these embodiments, the reinforcing elements 30a, 30b are shorter than in the previous embodiments, and have a smaller contact area with the seat 7. This can be advantageous if the device 1 needs to be cut to fit the dimensions of a small female body.

[0073] A further embodiment is shown in FIG. 10. 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 can provide greater protection for the perineum, as the second portion 20 covers a larger portion of the perineum without covering the anus, as also shown in FIG. 11. Thus, forces are distributed over a larger area, thereby reducing the risk of injury to the perineum. Full or partial attachment of the second portion 20 to the anus 3 can be uncomfortable for the woman and may compromise attachment due to different tissue types and bodily fluids, which is why this should be avoided. In this embodiment, the reinforcing elements are not visible but are present inside the sheet 7.

[0074] FIG. 12 shows the embodiment of FIG. 11 in side view, with side sections 22 a , 22 b extending beyond bend 9 .

[0075] In the embodiment of FIG. 13, the side sections 22a, 22b extend beyond the bend to a lesser extent than in the embodiment of FIG. 12, and the first portion 10 is longer than in FIG.

[0076] Figure 14 is a principle diagram showing 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 extends on either side of it in the same manner as shown in Figure 11. The first portion 10 may alternatively be longer, as can be seen in Figure 15. An embodiment in which the device does not extend below the anus is also possible, as shown in Figure 16, which corresponds in principle to the situation in Figure 5.

[0077] 17 depicts a perineal trauma reduction device 1 in which the first portion 10 is longer than in previous embodiments and has a curvature in the delivery position. The first portion 10 is thicker at the tip and sides compared to the central section. This may facilitate insertion into the vaginal opening.

[0078] Figures 18 and 19 show a further embodiment in which the first section 10 has a curvature similar to that of Figure 17, but is slightly shorter, and the second section 20 is also smaller than that of Figure 17. This embodiment may be advantageous, for example, for women with smaller than average bodies. In contrast to the embodiments of Figures 1 and 2, the embodiment of Figure 18 does not have a recess at the bend 9. This may provide a strength advantage.

[0079] Further embodiments illustrating possible variations in size and shape of first portion 10 and second portion 20 are shown in Figures 20 through 25. It should be understood that these are merely examples and that further variations and combinations are within the scope of the present invention.

[0080] List of Reference Numbers 1 device 2 Urethral meatus 3 anus 4 Anal sphincter 51 Female Body 52 children 6. Vaginal opening 7. Sheet of flexible material 8. Vaginal wall 9 Bend 91a recess 91b recess 10 First Part 20 Second Part 21 Central Section 22a Side Section 22b side section 30a reinforcement elements 30b reinforcement element 31a First end of reinforcing element 30a 31b First end of reinforcing element 30b 32 Inner 33 Exterior

Claims

1. 1. A perineal trauma reduction device for reducing trauma during vaginal birth of a child, comprising: a first portion configured to be inserted into a woman's body through the vaginal opening at a portion posterior to the vaginal opening; a second portion configured to extend from a posterior portion of the vaginal opening toward the anus and outside the female body; an inner surface extending across the first portion and the second portion and configured to contact a surface of the female anatomy; the outer surface is opposite the inner surface; the inner and outer surfaces are formed by sheets of flexible material; the perineal trauma reduction device further comprises at least one reinforcing element for stabilizing the seat; the at least one reinforcing element extends across both the first portion and the second portion; The perineal trauma reduction device, wherein the second portion includes at least one attachment element on the inner surface configured to attach to a surface of the female body.

2. The perineal trauma reduction device of claim 1 , wherein the inner surface of the first portion comprises a smooth surface.

3. 3. The perineal injury reduction device of claim 1 or 2, wherein the second portion comprises two side sections and a central section, and wherein the at least one reinforcing element extends through the central section and outwardly toward edges of the side sections.

4. The perineal trauma reduction device of claim 3 , wherein the at least one reinforcing element further extends inwardly back toward the central section of the second portion.

5. 5. The perineal injury reduction device of any one of claims 1 to 4, wherein 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.

6. 6. The perineal trauma reduction device of claim 5, wherein in a birthing condition, the device is preformed with the bend between the first and second portions.

7. 7. The perineal injury reduction device of claim 5 or 6, wherein the sheet of flexible material has a thickened portion at the bend.

8. 8. The perineal trauma reduction device of any one of claims 1 to 7, wherein the at least one reinforcing element is elastic and pulls the device towards a birthing position.

9. 9. A perineal injury reduction device according to any one of claims 1 to 8, wherein the reinforcing element has a higher stiffness than the sheet.

10. 10. The perineal trauma reduction device of any one of claims 1 to 9, wherein the reinforcing element is embedded in the sheet of flexible material between the inner surface and the outer surface.

11. The perineal trauma reduction device of claim 1 , wherein the attachment element comprises an adhesive.

12. 12. A perineal trauma reduction device according to any one of claims 1 to 11, having a thickness of from 0.1 mm to 10 mm, more preferably from 0.5 mm to 5 mm.

13. 1. A method for reducing trauma during vaginal delivery of a child, comprising: providing a perineal trauma reduction device comprising a first portion and a second portion; a sheet of flexible material defining an inner surface and an outer surface opposite the inner surface, the inner surface extending across the first portion and the second portion; and at least one reinforcing element extending across both the first portion and the second portion to stabilize the sheet; positioning the perineal trauma reduction device so that the first portion is inserted through the vaginal introitus into the female body at the posterior vaginal introitus and the second portion extends outside the female body from the posterior vaginal introitus toward the anus, the inner surface contacting a surface of the female body; and attaching the second portion to a surface of the female body between the posterior vaginal opening and the anus using at least one attachment element on the interior surface.

14. 14. The method of claim 13, wherein the perineal trauma reduction device is bent before being placed on the female body so that the first portion and the second portion extend at an angle relative to one another.

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