Delivery Device

Abstract

The present invention relates to devices for assisting birth and / or preventing obstruction of birth, methods of making such devices, methods for assisting birth and / or preventing obstruction of birth. The invention also extends to the use of hydrogels for assisting birth and / or preventing obstruction of birth.

Description

[Technical field]

[0001] The present disclosure relates to devices for assisting childbirth. The present disclosure also relates to methods of making the devices, methods of using the devices to assist childbirth, and uses of hydrogels to assist childbirth.

[0002] Labour can be divided into three stages: the first stage: from diagnosis of labour to full cervical dilation (10 cm), the second stage: from full cervical dilation to delivery of the baby, which usually lasts less than 2 hours in nulliparous women and 1 hour in multiparous women, and the third stage: from delivery of the baby to complete delivery of the placenta and membranes.

[0003] During the second stage of labor, the fetal head experiences significant friction from the mother's birth canal. The performance of natural lubricants, which include a mixture of amniotic fluid, vernix caseosa, and vaginal fluids, varies from person to person. Natural lubricants may not fully cover the sliding surfaces throughout the birth process. In the absence of natural lubricants, contact between exposed skin and the birth canal can significantly increase the frictional forces generated during labor and can result in damage to the delicate mucous membrane of the birth canal. Damage to the mucous membrane can induce localized swelling, further increasing the frictional forces generated during labor.

[0004] To alleviate this problem, artificial lubricants such as water-based lubricating gels can be introduced into the birth canal during labor. However, the driving forces provided by uterine contractions and maternal pushing come in waves. As a result, the fetal movement through the birth canal undergoes a start-stop pattern at low speeds. Under such circumstances, liquid lubricants may be pushed off the sliding surfaces, exposing them to boundary lubrication and resulting in a significant increase in friction. Furthermore, water-based gel lubricants may reduce friction initially upon application. However, after a short period of time, friction usually increases significantly due to loss of water content through factors such as evaporation and / or absorption. The increased friction may make delivery of the baby more difficult, especially during obstructed labour.

[0005] Labor arrest occurs when the fetal emergence point does not extend from the birth canal despite strong uterine contractions (during the second stage). It can lead to fetal and maternal complications if not promptly relieved. Labor arrest can only be relieved by operative delivery, either Caesarean section or instrument-assisted delivery (e.g., forceps, vacuum extraction, or pubotomy). [Prior art documents] [Patent documents]

[0006] Summary of the Invention [Problem to be solved by the invention]

[0007] Thus, there is a need for improved means to assist birth and / or prevent labor arrest.

[0008] According to a first aspect of the present disclosure, a hydrogel membrane for covering at least a portion of the baby in the birth canal and / or for lining at least a portion of the birth canal during birth; A device for assisting childbirth is provided, including:

[0009] The hydrogel membrane for covering at least a portion of the baby during birth and / or lining at least a portion of the birth canal during birth may be at least about 1 cm 2 The one or more hydrogel membranes may have a total surface area of ​​about 1 cm. 2 ~About 3,000cm 2 may have a total surface area of

[0010] The membrane can be a 2D shape. The membrane can be for wrapping around a portion of the baby while it is in the birth canal. For example, the membrane can be a 2D shape capable of wrapping around a portion of the baby and / or lining a portion of the birth canal. The membrane can be a (3D) closed loop capable of wrapping around a portion of the baby while it is in the birth canal and / or lining a portion of the birth canal. Wrapping can mean wrapping the baby around its longitudinal axis (circumferential wrapping) and / or wrapping the baby along its longitudinal axis. That is, the device (e.g., hydrogel membrane) can be a sleeve. The hydrogel membrane can be for wrapping the baby circumferentially.

[0011] The portion of the baby may be the baby's head, the baby's neck, the baby's torso, the baby's limbs, the baby's arms, or the baby's legs. The at least a portion of the birth canal may be 10%, 20%, 30%, 40%, 50%, 60%, 70%, 75%, 80%, 85%, 90%, 95%, 96%, 97%, 98%, 99% or 100% of the surface area of ​​the birth canal. The at least a portion of the baby may be at least about 10%, 20%, 30%, 40%, 50%, 60%, 70%, 75%, 80%, 85%, 90%, 95%, 96%, 97%, 98%, 99% or 100% of the surface area of ​​the baby's entire body, the baby's head, the baby's neck, the baby's torso, the baby's limbs, the baby's arms, or the baby's legs. The device may cover one or more parts of the baby selected from the group consisting of the baby's head, the baby's neck, the baby's torso, the baby's legs, the baby's arms, and the baby's legs.

[0012] The hydrogel membrane may include one or more (intermittent) non-hydrogel regions, such as strips. The non-hydrogel regions may include or be made of a high friction material.

[0013] In one embodiment, the hydrogel membrane includes or is in the shape of a crown that is worn over the baby's head, and the crown has an opening for receiving the baby's head.

[0014] That is, according to another aspect of the present disclosure, Including the crown that is placed on the baby's head, the crown having an opening for receiving the baby's head; The crown is made of or comprises a hydrogel; A device for assisting childbirth is provided.

[0015] The device (e.g., hydrogel membrane) may include a bulbous rim. The entire perimeter or circumference of the hydrogel membrane may be or may include a bulbous rim. That is, in one embodiment, the bulbous rim defines the perimeter or circumference of the hydrogel membrane. In another embodiment, the bulbous rim defines an opening in the crown. That is, the opening may include a bulbous rim.

[0016] According to another aspect of the present disclosure, A crown placed on the baby's head, a rounded rim defining an opening in the crown; The opening is for receiving the baby's head, The crown and rim are made of or comprise a hydrogel; A device for assisting childbirth is provided.

[0017] The rolled rim may be made from or include a hydrogel. The rolled rim may be made from or include the same hydrogel as the crown or hydrogel membrane. The rolled rim may be made from or include a non-hydrogel material, for example a high friction material. The rolled rim may include one or more (intermittent) non-hydrogel areas, such as strips. The rolled rim or the non-hydrogel areas may be made from or include a high friction material. The high friction material referred to in this application may be one or more selected from the group including or consisting of rubber, silicone, polyethylene, polyurethane, nylon, polydimethylsiloxane, polyvinyl chloride, polyethersulfone, polytetrafluoroethylene, polyetherimide, polycarbonate, polysulfone, polyetheretherketone and polypropylene.

[0018] In one embodiment, the device can be a cap, hi another embodiment, the device can be a sleeve.

[0019] The device of the present invention can be used to assist birth and / or prevent labor arrest. This is achieved by (i) preventing direct (sticky) contact between the unborn baby and the mucosal tissue of the birth canal, and (ii) creating a (lubricious) hydrogel surface in contact with the mucosal tissue of the birth canal. In other words, the device acts as an interface between the skin of the unborn baby and the mucosal tissue of the birth canal during birth. Furthermore, the self-lubricating properties of the hydrogel ensure that the device is continuously lubricated as it is used. It also allows the device to be used for extended periods of time without drying out. As a result, once the device is in place (in the birth canal), it: 1) providing a lower degree of friction at the baby-device interface compared to the degree of friction at the device-birth canal interface, resulting in the delivery of the baby without a device (this is most likely when the device is in the form of a sleeve and is anchored to the birth canal); 2) providing a lower degree of friction at the device-birth canal interface compared to the degree of friction at the baby-device interface, resulting in simultaneous delivery of the baby and device (this is most likely when the device is one that is placed over the baby's head); 3) providing a combination of (1) and (2) (this is most likely when the device is oversized), or 4) in embodiments where the device provides multiple hydrogel surfaces between the baby and the mucosal tissue of the birth canal, providing a lower degree of friction at the interface of the hydrogel surfaces so that the surfaces slide against one another (and aid in the delivery of the baby), or providing a combination of (1)-(3); This aids in childbirth.

[0020] The hydrogel of the device can be reinforced with synthetic polymer fibers. That is, the hydrogel membrane, the hydrogel of the crown, or the hydrogel of the sleeve can be reinforced with synthetic polymer fibers. The hydrogel of the rolled rim can be reinforced with synthetic polymer fibers. The hydrogel of the crown or the hydrogel membrane, or the hydrogel of the sleeve can be reinforced with synthetic polymer fibers, but the hydrogel of the rolled rim can be not reinforced with synthetic polymer fibers. The hydrogel of the rolled rim can be reinforced with synthetic polymer fibers, but the hydrogel of the crown, the hydrogel of the membrane, or the hydrogel of the sleeve can be not reinforced with synthetic polymer fibers. The hydrogel of the rolled rim can be reinforced with synthetic polymer fibers, but the hydrogel of the crown, the hydrogel of the membrane, or the hydrogel of the sleeve can be not reinforced with synthetic polymer fibers.

[0021] The device (e.g., sleeve) in one embodiment may also be for covering the baby's torso, i.e., the device or crown may be for covering the baby's head over its torso.

[0022] The device or crown in one embodiment can be a cap. In this embodiment, the opening in the crown is for receiving the circumference of the baby's head. That is, the cap can be for covering from the top (or crown) of the baby's head to the circumference of the baby's head or up to the baby's neck. The cap can be placed over at least the baby's head. The cap can be for covering the baby's torso. That is, the cap can be for covering from the top of the baby's head to the baby's torso. The cap can be for covering from the top of the baby's head up to and including the baby's feet. The crown can be folded to create a double layer of hydrogel between the baby's head and the mucosal tissue of the birth canal.

[0023] The device or crown in one embodiment may be a sleeve. The sleeve may be used to assist in birth by creating a lubricious surface that prevents direct contact between the baby's skin (e.g., only the head, a portion of the baby, or the entire body) and the mucosal tissue of the birth canal. The sleeve may include a first opening and an opposing second opening. The sleeve may have a first rounded rim at one end that defines the first opening and a second opening at the other end. The sleeve may further include a (third) rounded rim located between the first rounded rim and the second opening. The second opening may be defined by the second rounded rim. That is, the sleeve may include a second rounded rim located at the second opening. The first rounded rim may be for sitting on top of the baby's head. That is, the first rounded rim or the first opening may have a smaller diameter (or greatest length) than the baby's head. The second round rim and / or the third round rim or the second opening may have a larger diameter (or a longer length) than the first round rim. The second round rim and / or the third round rim or the second opening may have a larger diameter (or a longer length) than the baby's head. The second round rim and the third round rim may be of the same length circumference or have the same diameter. The sleeve may be used as a crown, i.e. the crown or sleeve may be placed over at least the baby's head. The sleeve may be for covering the baby's torso, i.e. the sleeve may be for covering from the baby's head to the baby's torso. The sleeve may cover from the baby's head to the baby's feet and including the feet. The sleeve may be folded to create a double layer of sleeve material between the baby's head (and optionally the baby's body) and the surface of the birth canal. The double layer of hydrogel may facilitate the baby's passage through the birth canal.

[0024] The crown may be any shape that at least covers or can be used to be placed over the baby's head, i.e., in one embodiment, the cap or sleeve may be in the shape of a cone.

[0025] The baby's head is usually the most challenging body part to push out of the birth canal due to its relative size. Once the head has fully emerged from the birth canal, the rest of the body can be pushed out relatively easily. That is, the cap may cover only the baby's head. The cap may cover at least about 50%, at least about 60%, at least about 70%, at least about 80%, or at least about 90% of the baby's head while the baby's head is in the birth canal. However, the sleeve may be used to cover at least about 50%, at least about 60%, at least about 70%, at least about 80%, or at least about 90% of the baby's body while the baby's body is in the birth canal.

[0026] The crown may be made of or include one or more separate panels of hydrogel. The crown of the cap may include a handle to aid in removal of the cap. The cap may include a handle connected via an extraction cord to the crown to aid in removal of the cap. The extraction cord may be attached to the upper half and outer surface of the crown. The crown may be dome-shaped.

[0027] The cap opening may have a diameter (or largest length) of greater than 7 cm, or greater than 8 cm, or greater than 9 cm. Thus, the cap opening may have a circumference of greater than 22 cm, or greater than 25 cm, or greater than 28 cm. The cap opening may have a diameter between about 7 cm and about 15 cm, between about 7 cm and about 12 cm, preferably between about 8 cm and about 14 cm. The cap opening may have a circumference of between about 22 cm and about 47 cm, between about 22 cm and about 37 cm, between about 25 cm and about 44 cm, or between about 26 cm and about 40 cm. Preferably, the circumference is at least about 24 cm, or between about 24 cm and about 40 cm, or about 40 cm.

[0028] The first opening of the sleeve may have a diameter (or largest length) of less than 12 cm, or less than 11 cm, or less than 10 cm, or less than 9 cm, or less than 8 cm. Thus, the first opening of the sleeve may have a circumference of less than 37 cm, or less than 35 cm, or less than 31 cm, or less than 28 cm, or less than 26 cm, or less than 25 cm. The second opening of the sleeve may have a diameter of more than 7 cm, or more than 8 cm, or more than 9 cm, or more than 13 cm. The second opening of the sleeve may have a circumference of more than 22 cm, or more than 25 cm, or more than 28 cm, or more than 40 cm. The first opening of the sleeve may have a diameter (or largest length) between about 7 cm and about 12 cm. The first opening of the sleeve may have a circumference between about 22 cm and about 38 cm. The diameter (or largest length) or circumference of the first opening may be smaller than the second opening. That is, the diameter (or greatest length) of the second opening can be about 12 cm or more, about 14 cm or more, or about 16 cm or more. Thus, the circumference of the second opening can be about 38 cm or more, about 40 cm or more, about 44 cm or more, about 47 cm or more, or about 50 cm or more. The diameter (or greatest length) of the second opening can be about 16 cm. The circumference of the second opening can be about 47 cm or about 50 cm.

[0029] Those skilled in the art will appreciate that the size of the opening in the device will ultimately be determined by how it is intended to be used. The size of the opening or openings will be determined by the circumference of the newborn's head. The circumference of a newborn's head is between 26 cm and 40 cm. However, most newborns have head circumferences between 30 cm and 37 cm in length. In view of this, in one embodiment, the sleeve may be used to assist in the delivery of the baby without the sleeve being simultaneously present in the birth canal. That is, the circumference of the first opening may be greater than about 24 cm and the circumference of the second opening may be greater than about 24 cm; the circumference of the first opening may be greater than about 26 cm and the circumference of the second opening may be greater than about 26 cm; the circumference of the first opening may be greater than about 28 cm and the circumference of the second opening may be greater than about 28 cm; the circumference of the first opening may be greater than about 30 cm and the circumference of the second opening may be greater than about 30 cm; or the circumference of the first opening may be greater than about 32 cm and the circumference of the second opening may be greater than about 32 cm. The circumference of the first opening may be between about 24cm and 40cm and the circumference of the second opening may be between about 24cm and 40cm, the circumference of the first opening may be between about 26cm and 40cm and the circumference of the second opening may be between about 26cm and 40cm, the circumference of the first opening may be between about 28cm and 40cm and the circumference of the second opening may be between about 28cm and 40cm, or the circumference of the first opening may be between about 30cm and 40cm and the circumference of the second opening may be between about 30cm and 40cm.

[0030] In other embodiments, the device (e.g., sleeve or cap) may be used to aid in the delivery of a baby, preferably by being present in the birth canal at the same time as the baby, i.e., the sleeve may have a first opening with a circumference less than about 30 cm and a second opening with a circumference greater than about 37 cm, or the first opening with a circumference less than about 28 cm and a second opening with a circumference greater than about 35 cm, or the first opening with a circumference less than about 28 cm and a second opening with a circumference greater than about 32 cm, or the first opening with a circumference less than about 26 cm and a second opening with a circumference greater than about 30 cm, or the first opening with a circumference less than about 26 cm and a second opening with a circumference greater than about 28 cm. The circumference of the first opening may be between about 0cm and 30cm and the circumference of the second opening may be between about 24cm and 40cm, the circumference of the first opening may be between about 10cm and 28cm and the circumference of the second opening may be between about 26cm and 40cm, the circumference of the first opening may be between about 15cm and 26cm and the circumference of the second opening may be between about 28cm and 40cm, or the circumference of the first opening may be between about 20cm and 26cm and the circumference of the second opening may be between about 30cm and 40cm.

[0031] The circumference of the opening of the (first) cap may be less than about 30 cm, less than about 28 cm, or less than about 26 cm. Preferably, the circumference is less than about 26 cm.

[0032] The (first and / or second) bulbous (in cross section) rims may be any closed loop shape, such as square, elliptical, or annular. The bulbous rim(s) may be elliptical or annular. Preferably, the bulbous rim(s) form an elliptical or annular shape along the circumference of the opening. The cross section of the bulbous rim(s) may be any shape, including square, elliptical, or annular. The cross section of the bulbous rim(s) may be elliptical or annular. The thickness of the bulbous rim(s) may be less than about 10 mm, less than about 9 mm, less than about 8 mm, less than about 7 mm, less than about 6 mm, less than about 5 mm, less than about 4 mm, or less than about 3 mm. The thickness of the rim(s) may be greater than about 2 mm, greater than about 3 mm, greater than about 4 mm. The thickness of the rim(s) may be between about 1 mm and 20 mm, or between about 2 mm and 10 mm. Preferably, the thickness of the rim(s) is between about 2 mm and about 5 mm. The lubricious nature of the hydrogel makes the crown difficult to grip or handle. The rounded rim(s) facilitates the handling of the device (e.g., cap, membrane or sleeve). To further improve the ease with which the device of an embodiment can be handled, the rounded rim can be made of or include a non-hydrogel material, such as a high friction material. The high friction material can be one or more selected from the group including or consisting of rubber, silicone, polyethylene, polyurethane, nylon, polydimethylsiloxane, polyvinyl chloride, polyethersulfone, polytetrafluoroethylene, polyetherimide, polycarbonate, polysulfone, polyetheretherketone and polypropylene.

[0033] A portion of the rolled rim may include or be made from a hydrogel. A portion of the rolled rim may include or be made from a non-hydrogel material. That is, the rolled rim may include or be made from one or more regions of a hydrogel and one or more regions of a non-hydrogel material (e.g., high friction material, rubber, etc.).

[0034] The device may include means to aid in the insertion, support and / or removal of the device from the birth canal. The means to aid in the insertion, support and / or removal of the device from the birth canal may be referred to as a guide. The means to aid in the insertion, support and / or removal of the device may be a rolled rim as referred to herein. The means to aid in the insertion, support and / or removal of the device may be a pocket in the membrane, rim and / or crown to allow one or more fingers to be inserted therein. The means to aid in the insertion, support and / or removal of the device may be a handle or extraction cord attached to or integral with the membrane, rim and / or crown. The extraction cord may be fixed to the synthetic polymer fiber. The extraction cord may be manufactured from the same material as the synthetic polymer fiber. The extraction cord may be between about 7 cm and 30 cm in length. Thus, a method of assisting birth using an embodiment of the device may include pulling the extraction cord. The extraction cord may be located outside the birth canal when using the device.

[0035] Hydrogels can be made from a 3D network of hydrophilic polymers that is immersed in a liquid. The liquid can be absorbed by the 3D network of hydrophilic polymers, thus causing the 3D network to expand. Thus, the term "hydrogel" can refer to a 3D network of cross-linked hydrophilic polymers that contains a liquid that causes the network to expand. The advantage of using a hydrogel as part of an embodiment is its self-lubricating property. When placed under pressure, the hydrogel releases liquid (e.g., water) at the contact surface, thus maintaining the lubricity of the fluid-film and dramatically reducing the level of friction (friction coefficient). Furthermore, hydrogels are highly absorbent.

[0036] The device may be a single unit. The device may be a single unit hydrogel or hydrogel membrane. The device may be molded. The hydrogel is not dissolved in a liquid, such as water. In one embodiment, the hydrogel is not dissolved in a liquid, for example, at a temperature below 45° C. In another embodiment, the hydrogel is dissolved in a liquid, for example, at a temperature below 45° C. The hydrogel may be a physically crosslinked hydrogel or a chemically crosslinked hydrogel.

[0037] The hydrophilic polymer of the hydrogel can be natural or synthetic. Natural hydrophilic polymers include hyaluronic acid, chitosan, alginate, collagen, silk and fibroin. Synthetic hydrophilic polymers include polyvinyl alcohol (PVA), polyacrylamide (PAAm), polyhydroxyethyl methacrylate (HEMA) copolymers, polyethylene glycol (PEG), and polydimethylsiloxane (PDMS). The hydrophilic polymer of the hydrogel can be synthetic. Hydrogels can be natural or synthetic.

[0038] The hydrogel or hydrogel membrane can be biocompatible, i.e., the hydrophilic polymer and the fluid can be biocompatible. Biocompatible hydrophilic polymers include PVA, PEG, PAAm, HEMA, PDMS, and mixtures thereof. That is, the hydrogel or hydrogel membrane can be made from one or more polymers selected from the group consisting of PVA, PEG, PAAm, HEMA copolymers, and PDMS. The hydrogel or hydrogel membrane can be made from PAAm, i.e., the polymer of the hydrogel can be PAAm. PAAm creates a hydrogel with a very low coefficient of friction.

[0039] The hydrogel can be made from HEMA copolymers, such as poly(2-hydroxyethyl methacrylate / methacrylic acid) (HEMA-MAA) or HEMA-vinylpyrrolidone (HEMA-VP). That is, the polymer of the hydrogel can be HEMA-MAA or HEMA-VP. HEMA copolymers create a strong and stretchy hydrogel, so that it is more able to withstand the shear forces encountered during childbirth.

[0040] The hydrogel may be made from PVA, i.e., the polymer of the hydrogel may be PVA, which creates a hydrogel that is stretchy and therefore more able to withstand the shear forces encountered during childbirth.

[0041] Preferably, the hydrophilic polymer is a PAAm, PVA, or HEMA copolymer, i.e., the hydrogel may be made from a PAAm, PVA, or HEMA copolymer. More preferably, the hydrophilic polymer is a HEMA copolymer or PVA, i.e., the hydrogel may be made from a PVA or HEMA copolymer. Most preferably, the hydrophilic polymer is PVA, i.e., the hydrogel may be made from PVA.

[0042] The hydrogel polymer may be about 5% PVA to about 20% PVA (w / w). A hydrogel made from about 5% PVA to about 20% PVA (w / w) may have a coefficient of friction of about 0.4 or less. A hydrogel made from a polymer containing about 5% PVA has a low coefficient of friction. Preferably, the hydrogel polymer is about 15% PVA (w / w). A hydrogel made from a polymer containing about 15% PVA has a low coefficient of friction (e.g., about 0.4 or less) and exhibits some flexibility. The hydrogel polymer (e.g., HEMA copolymer, PVA, or PAAm) may contain water or be mixed with water. That is, for example, the hydrogel polymer may be about 95% water to about 80% water (w / w) and about 5% PVA to about 20% PVA (w / w).

[0043] The average molecular weight of the PVA can be between about 47000 g / mol and about 200500 g / mol, between about 61000 g / mol and about 195000 g / mol, between about 125000 g / mol and about 195000 g / mol, between about 125000 g / mol and about 195000 g / mol, or between about 145000 g / mol and about 186000 g / mol. Preferably, the average molecular weight of the PVA is between about 145000 g / mol and about 186000 g / mol, more preferably, the average molecular weight of the PVA is about 145000 g / mol. Thus, for example, the polymer of the hydrogel can be about 95% water to about 80% water (w / w) and about 5% PVA to about 20% PVA (w / w) with an average molecular weight of about 145000 g / mol and about 186000 g / mol.

[0044] The PVA of the hydrogel can be at least about 88% hydrolysed, at least about 92% hydrolysed, at least about 98% hydrolysed, or at least about 99% hydrolysed, or 100% hydrolysed.

[0045] Hydrogels made from PVA may have a viscosity of about 5 mPa-s to about 60 mPa-s, about 10 mPa-s to about 50 mPa-s, about 15 mPa-s to about 50 mPa-s, or about 20 mPa-s to about 50 mPa-s. Preferably, hydrogels made from PVA may have a viscosity of about 20 mPa-s to about 40 mPa-s. Most preferably, hydrogels made from PVA have a viscosity of about 28 mPa-s.

[0046] The viscosity can be measured by a Brookfield synchronous motor rotary type using a 4% aqueous solution at 200°C.

[0047] The polymer of the hydrogel can be about 7.5% PAAm to about 20% PAAm (w / w). A hydrogel made from about 7.5% PAAm to about 20% PAAm (w / w) has a coefficient of friction of about 0.1 or less. A hydrogel made from a polymer containing about 7.5% PAAm has a low coefficient of friction (e.g., about 0.1 or less). The polymer of the hydrogel can be about 15% PAAm (w / w). A hydrogel made from a polymer containing about 15% PAAm has a low coefficient of friction (e.g., about 0.1 or less) and is strong when combined with a mesh. Thus, for example, the polymer of the hydrogel can be about 92.5% water to about 80% water (w / w) and about 7.5% PAAm to about 20% PAAm (w / w).

[0048] The polymer of the hydrogel may be a HEMA copolymer. The polymer may be about 40% to about 98% HEMA copolymer (w / w). A hydrogel made from about 40% HEMA to about 98% HEMA (w / w) may have a coefficient of friction of about 0.1 or less. In an embodiment where the HEMA-copolymer is HEMA-MAA, the polymer may comprise about 90% to about 98% HEMA-MAA (w / w). Thus, for example, the polymer may be about 90% to about 98% HEMA-MAA (w / w) and about 10% to about 2% water (w / w). In an embodiment where the HEMA-copolymer is HEMA-VP, the polymer may comprise about 90% to about 40% HEMA-VP (w / w). Thus, for example, the polymer may be about 90% to about 40% HEMA-VP (w / w) and about 10% to about 60% water (w / w).

[0049] Once the polymer of the hydrogel is made (e.g., by mixing the polymer (powder) with water and drying the mixture), a liquid is added to the polymer (e.g., the dried mixture) to make the hydrogel. The liquid of the hydrogel or hydrogel membrane can be water (e.g., deionized water), a water-based lubricant, or an oil-based lubricant. Water-based lubricants do not include oil or silicone-containing lubricants. The liquid of the hydrogel (e.g., water) acts as a lubricant, thus making the hydrogel lubricous. The highly absorbent nature of the hydrogel can allow the device to absorb natural lubricants from the birth canal within it.

[0050] The presence of liquid (e.g., water) in the hydrogel causes the hydrophilic hydrogel polymer to swell. The swelling ratio of the polymer can be between 2-20:1.

[0051] In one embodiment, the hydrogel comprises a 3D network of a hydrophilic polymer (e.g., PVA or HEMA copolymer) and water (e.g., deionized water) to facilitate swelling of the 3D network, i.e., the hydrogel may comprise a 3D network of PVA and water (e.g., deionized water).

[0052] The coefficient of friction of the device can be calculated using a "2D"-bench test setup (see FIG. 4(A)).

[0053] The "2D" bench test setup (Biometer [BTM, PS Instruments, London]) measures the frictional forces generated during sliding contact between synthetic skin (141500, Syndaver, Tampa FL, USA) used to simulate the skin head of a baby and synthetic vaginal tissue (141690, Syndaver, Tampa FL, USA) used to simulate the tissue of the birth canal, optionally using an embodiment of the device as the interface between the synthetic tissue and the synthetic skin. The experimental conditions used in the "2D" setup are as follows: TIFF2025503329000002.tif57140

[0054] The output of the "2D" setup is the static friction coefficient.

[0055] The "3D" birth simulator setup measures the resistance and distance traveled when an artificial head covered with SynDaver® fetal skin (141500, Syndaver, Tampa FL, USA [5 mm thick]) instead of the one covered with the device of one embodiment is pushed through an artificial birth canal lined with SynDaver® vaginal tissue (141690, Syndaver, Tampa FL, USA [20 mm thick]). In other words, the 3D setup simulates and measures the amount of energy required from the mother to push the baby out of the birth canal with and without the device of one embodiment. The artificial head can be pushed through the birth canal over 70 mm at a speed of 1 mm / s. The outputs measured are the instantaneous force N and the total work done J. These output values ​​can be used to calculate the total energy loss using the following formula: TIFF2025503329000003.tif13150, where x i represents the cumulative displacement of the "fetal head" into the "birth canal" in step i. The sum of steps n is 7000, where the actual cumulative displacement and instantaneous force F i is measured by the system.

[0056] The device of one embodiment, particularly the hydrogel or hydrogel membrane, has a low coefficient of friction, which can mean a value of about 0.5 or less, about 0.4 or less, about 0.3 or less, about 0.2 or less, or about 0.1 or less (according to a 2D bench set-up).

[0057] The coefficient of friction of the hydrogel or hydrogel membrane of the device of one embodiment may be about 1 or less, about 0.9 or less, about 0.8 or less, about 0.7 or less, about 0.6 or less, about 0.5 or less, about 0.4 or less, about 0.3 or less, about 0.2 or less, or about 0.1 or less. A device comprising a PAAm hydrogel or hydrogel membrane may have a coefficient of friction of about 1 or less, about 0.9 or less, about 0.8 or less, about 0.7 or less, about 0.6 or less, about 0.5 or less, about 0.4 or less, about 0.3 or less, about 0.2 or less, or about 0.1 or less. A device comprising a PVA hydrogel or hydrogel membrane may have a coefficient of friction of about 1 or less, about 0.9 or less, about 0.8 or less, about 0.7 or less, about 0.6 or less, about 0.5 or less, about 0.4 or less, about 0.3 or less, about 0.2 or less, or about 0.1 or less. Devices containing PEG hydrogels or hydrogel membranes may have a coefficient of friction of about 1 or less, about 0.9 or less, about 0.8 or less, about 0.7 or less, about 0.6 or less, about 0.5 or less, about 0.4 or less, about 0.3 or less, about 0.2 or less, or about 0.1 or less. Devices containing HEMA copolymer hydrogels or hydrogel membranes may have a coefficient of friction of about 1 or less, about 0.9 or less, about 0.8 or less, about 0.7 or less, about 0.6 or less, about 0.5 or less, about 0.4 or less, about 0.3 or less, about 0.2 or less, or about 0.1 or less. Devices containing PDMS hydrogels or hydrogel membranes may have a coefficient of friction of about 1 or less, about 0.9 or less, about 0.8 or less, about 0.7 or less, about 0.6 or less, about 0.5 or less, about 0.4 or less, about 0.3 or less, about 0.2 or less, or about 0.1 or less. The coefficient of friction may be calculated using a "2D" Benli test set-up.

[0058] Those skilled in the art will appreciate that the thicker the hydrogel layer, the more difficult it is to place the cap on the baby's head in the birth canal and the more difficult it is to deliver the baby. However, the thinner the hydrogel layer, the more likely it is to break. As a result, the hydrogel may include synthetic polymer fibers (e.g., polyamide fibers such as nylon). The synthetic polymer fibers may be embedded or immersed (impregnated) in the hydrogel. The synthetic polymer fibers may reinforce the hydrogel without substantially increasing the overall thickness of the hydrogel. The term "substantially" may mean an increase of less than about 30%, less than about 25%, less than about 20%, less than about 15%, less than about 10%, less than about 5%, or less than about 1%. The term "substantially" may mean no increase in the overall thickness of the hydrogel.

[0059] The synthetic polymer fibers may be woven or non-woven. The synthetic polymer fibers (e.g., polyamide fibers such as nylon) may form a mesh. The synthetic polymer fibers may form at least one layer of synthetic polymer fibers, or two or more layers. The layer or layers of synthetic polymer fibers may be porous or non-porous. The layer of synthetic polymer may be a mesh, for example, a knit mesh. The mesh may be an open mesh, a filter mesh, a woven mesh, or a warp knit mesh. The mesh may be warp knit, which provides a smooth surface while maintaining reasonable flexibility at a low thickness. The synthetic polymer fibers do not degrade in liquids such as hydrogels or water.

[0060] Advantageously, the synthetic polymer fibers allow the hydrogel of the device to have a minimal thickness while maintaining low friction and good flexibility / tensile strength. They also prevent the hydrophilic polymer network from deforming due to excessive swelling. That is, they allow the hydrogel to maintain a well-defined structure.

[0061] The pores of the mesh or the layer of synthetic polymer fibers may have a diameter (or maximum length) of about 0.5 mm to about 20 mm. Pores in this range can reinforce the hydrogel and prevent it from swelling excessively. The pores may have a diameter (or maximum length) of about 1.0 mm. The fibers of the mesh may have a thickness / diameter between about 0.05 mm and 0.4 mm. The fibers of the mesh may have a diameter / thickness of about 0.2 mm. Preferably, the mesh (e.g., polyamide) has a pore size of 0.4 mm x 0.4 mm and fibers of a thickness of about 0.2 mm.

[0062] The synthetic polymer of the synthetic polymer fiber may be hydrophilic or hygroscopic, i.e., the synthetic polymer fiber may form hydrogen bonds with water molecules in the hydrogel. The water molecules may also form hydrogen bonds with the polymer of the hydrophilic hydrogel. That is, the hydrogen bonds help prevent delamination or separation of the hydrogel from the synthetic polymer fiber when the device is placed under stress. The synthetic polymer of the synthetic polymer fiber may be one or more selected from the group consisting of polyamide (e.g., nylon), polyacrylonitrile, polyester, polypropylene, polybutester, polyurea, and polyurethane. Preferably, the synthetic polymer may be polyamide. More preferably, the synthetic polymer is nylon or elastane (i.e., a copolymer of polyether and polyurea). More preferably, the synthetic polymer fiber forms at least one layer of polyamide (e.g., nylon). At least one layer of porous polyamide may be porous.

[0063] In one embodiment, the synthetic polymer fibers are made of or include polyamide (e.g., nylon) and the hydrogel is made of PVA and water (e.g., deionized water). In another embodiment, the synthetic polymer fibers are made of or include polyamide (e.g., nylon) and the hydrogel is made of or include HEMA copolymer and water (e.g., deionized water). In another embodiment, the synthetic polymer fibers are made of or include polyamide (e.g., nylon) and the hydrogel is made of or include PAAm copolymer and water (e.g., deionized water). The synthetic polymer fibers can be made into a mesh by warp knit formation.

[0064] The hydrogel crown or hydrogel membrane may be less than 2 mm, less than 1.5 mm, less than 1.0 mm, or less than 0.5 mm thick. The hydrogel crown may be greater than 0.01 mm, greater than 0.05 mm, greater than 0.1 mm, greater than 0.2 mm, greater than 0.25 mm, greater than 0.3 mm, or greater. Preferably, the hydrogel crown or hydrogel membrane is between about 0.05 mm and 10 mm thick, between about 0.1 mm and 2 mm thick, or between about 0.05 mm and 0.5 mm thick. The hydrogel crown or hydrogel membrane may be of uniform thickness.

[0065] The rolled rim is thicker than the crown or hydrogel membrane wall (remainder) of the device. The rolled rim can be at least about 5 times, at least about 10 times, at least about 20 times, at least about 50 times, or at least about 100 times thicker than the crown or hydrogel membrane wall, preferably the rolled rim is about 5 to about 10 times thicker, and most preferably the rim is about 5 times thicker.

[0066] The crown may be between 0.5mm and 2mm thick and made from PVA hydrogel. The crown may be between 0.5mm and 2mm thick and made from 5%-20% PVA hydrogel. The crown may be between 0.5mm and 2mm thick and made from about 15% PVA hydrogel. The hydrogel membrane may be between 0.5mm and 2mm thick and made from PVA hydrogel. The membrane may be between 0.5mm and 2mm thick and made from 5%-20% PVA hydrogel. The hydrogel membrane may be between 0.5mm and 2mm thick and made from about 15% PVA hydrogel.

[0067] One surface of the device may include a high friction material. The high friction material may be one surface of the crown or membrane and / or the rolled rim. The high friction material may be a material mentioned in the present application. For example, the high friction may be one or more materials selected from the group consisting of rubber, silicone, polyethylene, polyurethane, nylon, polydimethylsiloxane, polyvinyl chloride, polyethersulfone, polytetrafluoroethylene, polyetherimide, polycarbonate, polysulfone, polyetheretherketone and polypropylene. In an embodiment in which the device is reinforced with synthetic polymer fibers, the high friction material may be extruded from the inside of the hydrogel to the outside surface, for example, against the outside surface of the crown, sleeve, cap, membrane and / or the rolled rim. The high friction material may be present on the inside surface of the device (i.e., the surface that contacts the baby during use). That is, when present in the birth canal, the outside surface of the device is more likely to slide against the birth canal than the inside surface of the device, which slides against the baby. As a result, the device can assist in the delivery of the baby and preferably exit the birth canal at the same time. In other embodiments, a high friction material may be present on the outer surface of the device (i.e., the surface that contacts the birth canal during use), such that when present in the birth canal, the baby is more likely to slide against the inner surface of the device than the outer surface of the device which slides against the birth canal, thereby allowing the device to assist in the delivery of the baby and, preferably, exit the birth canal at the same time.

[0068] According to a second aspect of the present disclosure, molding a hydrogel solution containing synthetic polymer fibers into the shape of a device for assisting childbirth; A method of manufacturing a device for assisting childbirth is provided, comprising:

[0069] According to another aspect of the present disclosure, A method of manufacturing a device for assisting childbirth is provided that includes molding a hydrogel solution into the shape of the device for assisting childbirth.

[0070] In one embodiment, the hydrogel solution includes synthetic polymer fibers.The method of the invention can be for producing a device according to the present disclosure.

[0071] Molding can include casting a hydrogel solution to create a cast containing the hydrogel solution and synthetic polymer fibers, initiating hydrogel formation, and solidifying the cast into the shape of the device to assist childbirth. Molding can be injection molding, casting, or compression molding.

[0072] The hydrogel solution may be made by mixing a powder of a hydrophilic polymer in a liquid to prepare a mixture. The liquid may be water, preferably deionized water.

[0073] The "start" step may include performing a heating / cooling process, in which the cast / mixture may be heated until a clear, transparent, viscous solution is prepared. The cast / mixture may be mixed during the heating step.

[0074] The solidifying step may include waiting for the cast to solidify (or cool) at room temperature. The solidifying step may be carried out at about 10° C. to about 25° C. Preferably, the solidifying step may be carried out at about 20° C. The solidifying step may include using UV light.

[0075] The curing step may be at least about 10 minutes, at least about 20 minutes, or at least about 30 minutes in length. Preferably, the curing step is about 30 minutes in length. The cooling step may be at least about 10 minutes to about 50 minutes, or about 20 minutes to about 40 minutes in length.

[0076] That is, the solidification step may be carried out at about 10° C. to about 25° C. for about 20 minutes to about 40 minutes.

[0077] The method of the present invention may further comprise performing 1, 2, 3 or 4 freeze / thaw cycles, preferably after the solidification step. The method of the present invention may further comprise performing 2 or 3 freeze / thaw cycles, preferably after the solidification step. The freeze / thaw cycles have an effect on the mechanical characteristics of the hydrogel.

[0078] The freeze / thaw cycle may involve freezing the device at about -35° C. to about -15° C. for at least about 12 hours, followed by thawing the device at about 4° C. for at least about 4 hours. The freeze / thaw cycle may involve freezing the device at about -25° C. for at least about 12 hours, followed by thawing the device at 4° C. for about 4 hours.

[0079] The method of the present invention may optionally further comprise hydrating the device after the freeze / thaw step. The hydration of the device may be carried out by placing the device in a liquid such as water (e.g., deionized water) or an aqueous solution. The hydration step may be carried out (e.g., with water) for about 12-48 hours, about 18-48 hours, or about 24 hours. Preferably, the hydration step may be carried out in water or an aqueous solution for up to about 48 hours. Preferably, the hydration step is carried out at about 10° C. to about 25° C. for about 24 hours.

[0080] The method of the second aspect may be used to manufacture a device (eg, a cap, sleeve or hydrogel membrane) in accordance with the present disclosure.

[0081] According to a third aspect, there is provided a device produced or producible by the method of the present disclosure.

[0082] According to the fourth perspective, placing a device of the disclosed subject matter over the baby's head within the subject's birth canal to assist in birth; or The device of the present disclosure is used to line at least a portion of the birth canal and / or cover at least a portion of the baby within the birth canal during birth. Methods are provided for assisting childbirth by a pregnant woman (pregnant subject), particularly by preventing arrest of labor, including:

[0083] Placing the device on the baby's head in the birth canal, or lining at least a portion of the birth canal, or covering at least a portion of the baby in the birth canal breaks the contact between the baby or the baby's head and the mucosal tissue of the birth canal. Mechanical pressure on the hydrogel during birth causes the hydrogel to release its liquid (e.g., water) to generate a lubricating fluid film. The film is generated without the need for movement between the baby and the mother. This type of lubricity, which relies on the low compliance of the hydrogel and its ability to contain an interfacial water film without relative movement, results in a stable and low friction interaction between the device and the tissue of the birth canal. In other words, the method of the present disclosure allows for assisting birth or preventing (preventing) labor arrest by reducing the level of friction between the baby and the birth canal.

[0084] Placing the device on the baby's head in the birth canal can include folding the crown or sleeve such that there is a double layer of reinforced hydrogel between the baby's head and the birth canal. Lining at least a portion of the birth canal or covering at least a portion of the baby in the birth canal can include folding a hydrogel membrane such that there is a double layer of reinforced hydrogel between the baby's head and the birth canal.

[0085] The term "childbirth" in this application means birth through the birth canal or unassisted vaginal delivery. Childbirth does not include birth through a Caesarean section. That is, childbirth includes, for example, delivering a child in a breech position or a cephalic position. The sleeve of the present disclosure may be used for delivery of a breech baby.

[0086] For birth to occur through the birth canal (23), the baby, and in particular the head (19), must pass through the pregnant woman's pelvis (25) (see Figure 9). Figure 9 shows the baby's head (19) covered within the cap (21) in the birth canal (23).

[0087] The pelvic bone may be divided into three regions: (1) the inlet (superior aperture), (2) the cavity, and (3) the outlet (inferior aperture). The inlet is wider in the transverse direction than in the anteroposterior direction, the cavity is circular, but the outlet is wider in the anteroposterior direction.

[0088] In one embodiment, the method of the present invention includes placing the device on the baby's head while the pregnant woman is in the second stage of labor. That is, the method of the present invention of the fourth / third aspect includes inserting the device into the birth canal of the subject and placing it on the baby's head (and optionally the body). Alternatively, the method of the present invention of the fourth aspect may include inserting the device of an embodiment into the birth canal of the subject so as to prevent direct contact between the baby's skin and the mucous membrane lining of the birth canal. However, the method of the present invention may include distributing a liquid lubricant on the outer surface of the cap before insertion into the birth canal or within the birth canal.

[0089] An embodiment method may include placing a device (eg, a sleeve or cap) on the baby's head exhibiting cephalic (head first) presentation.

[0090] The fetal head is the widest part that must pass during the birthing process, and once the head has cleared the passageway, delivery of the remainder of the birth is relatively easy. The device of one embodiment may be placed on the baby's head (and optionally on the baby's body) to aid in the baby's passage through the pelvis. That is, the device may be placed on the baby once the widest part of the baby's head is at the entrance, cavity, or exit. The device may be placed on the baby once the widest part of the baby's head has cleared the entrance or cavity.

[0091] Station levels are used to assess the descent of the fetus through the birth canal, with station 0 being represented by the ischial spine in the maternal pelvic cavity. The device may be placed on the baby's head once descent is at or after station level 0. That is, the device may be placed on the baby's head at or after station level 0, 1, 2 or 3. Most preferably, the device is placed on the baby's head at or after station level 1.

[0092] The method of one embodiment may include placing a device on the baby's head during cephalic presentation.

[0093] A baby's head contains plates connected by cranial sutures. The cranial sutures between the bone plates are soft during birth, meaning the shape of the skull can change under pressure (molding) to fit through the passages. The bone plates can overlap each other, for example, during molding.

[0094] In addition to potentially changing the shape of the baby's head during delivery, fetal attitude can change. Posture refers to the baby's posture (i.e., flexed, deflexed, or extended). The position of the baby will determine what size the widest diameter is and will affect the ease with which the baby can be delivered.

[0095] The baby's head is not always fully flexed as it enters the pelvis. Flexion occurs as the head descends into the narrower mid-pelvis. The fetal chin tucks towards its chest so that its smaller presenting diameter allows easier passage through the maternal pelvic bones.

[0096] The widest diameter of the baby's head can be suboccipitobregmatic (well flexed), occipitofrontal (partially flexed or deflexed), occipitomental (extended brow presentation), or submentobregmatic (hyperextended face presentation).

[0097] The device may be placed on the baby's head when the baby's head is well flexed. The device may be placed on the baby's head when the baby's head is in a partially flexed or disflexed position. The device may be placed on the baby's head when the baby's head is in a flexed forehead position. The device may be placed on the baby's head when the baby's head is in a hyperflexed facial position.

[0098] In one embodiment, the device is placed on the baby's head when the head is in submental bregmatic (high anteflexion) or submental bregmatic (super flexed face position).

[0099] The baby's head may enter the pelvic inlet and exit in different positions (positions). At the exit, the baby may be in an occipito-anterior (OA) position, such as right occipito-maternal anterior position, orthogonal occipito-maternal anterior position, or left occipito-maternal anterior position. At the exit, the baby may be in an occipito-transverse position (OT) position, such as right temporal-maternal anterior position, orthogonal temporal-maternal anterior position, or left temporal-maternal anterior position. At the exit, the baby may be in an occipito-posterior (OP) position, such as right occipito-maternal posterior position, orthogonal occipito-maternal posterior position, or left occipito-maternal posterior position. Preferably, the baby is in the OA position.

[0100] That is, the device may be placed on the baby's head in the OA, OT or OP position.

[0101] The method of one embodiment may include removing the device from the baby once birth has occurred (ie, once the baby is delivered).

[0102] According to a fifth aspect, there is provided a use of the device of an embodiment for assisting birth and / or preventing labor arrest during birth.

[0103] In another aspect, a device is provided in an embodiment for use in preventing labor arrest during childbirth.

[0104] According to a sixth aspect there is provided a use of a hydrogel for assisting birth and / or preventing labour arrest during birth.

[0105] In one embodiment, the hydrogel is a hydrogel membrane. The hydrogel membrane may be a hydrogel membrane as referred to herein.

[0106] An embodiment may include using one or more separate hydrogel membranes, i.e., an embodiment may include using 1 or more, 2 or more, 3 or more, 4 or more, or 5 or more separate hydrogel membranes. An embodiment may include using a device of an embodiment to assist in birth or prevent labor arrest during birth.

[0107] In another embodiment, a hydrogel is provided for use in preventing labor arrest during childbirth.

[0108] The "device" referred to in this application may be a cap or sleeve of the present disclosure.

[0109] The term "hydrogel" may refer to a hydrogel membrane, such as the membranes referred to in this application.

[0110] "Hydrogel membrane" may mean a layer of insoluble material made from or including a hydrogel.

[0111] The term "lining" can refer to a covering. That is, the hydrogel membrane of the present disclosure covers at least a portion of the birth canal during childbirth, e.g., at least about 1 cm. 2 may be for covering a total surface area of

[0112] The term "comprising" may mean "consisting of" or "consisting essentially of."

[0113] Embodiments and features described in this application (including any accompanying claims, abstract and drawings) All of the features and / or steps of any disclosed method or process may be combined with any of the above aspects or embodiments in any combination, unless otherwise described with reference to a specific combination, e.g., a combination in which at least some of such features and / or steps are mutually exclusive. [Brief description of the drawings]

[0114] For a better understanding of the disclosure and to show how embodiments of the present disclosure can be put into effect, reference will now be made by way of example only and with reference to the drawings. [Figure 1] FIG. 1 shows (A) a CAD cap of one embodiment and (B) a drawing of the cap on a training dummy's head. [Diagram 2] FIG. 2 is a photograph of a training dummy's head emerging from the birthing dummy's birth canal while wearing a cap according to one embodiment. [Diagram 3] FIG. 3 shows (A) a photograph of a PAAm hydrogel sheet reinforced with a nylon warp knit mesh, (B) a photograph of a HEMA copolymer (HEMA-MAA) hydrogel dish without a mesh, and (C) a PVA hydrogel sheet reinforced with a nylon warp knit mesh. [Figure 4(A)] FIG. 4(A) is a schematic overview of the test setup used to measure the coefficient of friction of SynDaver® synthetic vaginal tissue vs. synthetic skin tissue with the addition of friction-reducing materials. [Figure 4(B)]FIG. 4(B) shows experimental results obtained with a 2D bench setup under different conditions, where "Syndaver Dry" refers to SynDaver® skin vs. vaginal tissue under padded and dry conditions, "Syndaver Wet" refers to SynDaver® skin vs. vaginal tissue with excess water, and "SynDaver® Hibitane" refers to SynDaver® skin vs. vaginal tissue with lubricant Hibitane™. "15% PVA(water)" refers to a hydrogel interface prepared from 15% PVA and water, "20% PVA(water)" refers to a hydrogel interface prepared from 20% PVA and water, and "15% PVA Hibitane" refers to a hydrogel interface prepared from 15% PVA and water and coated in lubricant Hibitane™. [Figure 4(C)] In FIG. 4(C), "Skin only" means that the slide surface was SynDaver® skin vs. PAAm hydrogel, "Vag only" means that the slide surface was SynDaver® vaginal tissue vs. PAAm hydrogel, and "Skin-Vag" means that the slide surface was SynDaver® skin vs. vaginal tissue with PAAm hydrogel sandwiched between them. [Diagram 5] FIG. 5 shows the effect of loading force on the static friction coefficient of wet hydrogel samples (15% PVA) tested using a 2D setup (SynDaver® vaginal / skin tissue). [Figure 6(A)] FIG. 6(A) shows the “3D”-birth-simulator setup with an artificial head covered with SynDaver® fetal skin positioned within an artificial birth canal lined with SynDaver® vaginal tissue. [Figure 6(B)] Figure 6(B) is a close-up of the "3D" birth-simulator setup with the prototype visible between the head and the birth canal. [Figure 7(A)]FIG. 7(A) shows the cumulative energy dissipation results for a simulated maternal push, where the fetal head was pushed at a fixed speed and over the same distance through the birth canal of a 3D-birth simulator, and different experimental conditions were each repeated three times, where "wet" means birth canal with excess water and no prototype, "dry" means moist birth canal padded and dried with paper towels and no prototype, "wet prototype" means birth canal with excess water and prototype on the fetal head, and "dry prototype" means birth canal with prototype on the fetal head. [Figure 7(B)] FIG. 7(B) shows a summary of the results of FIG. 7(A). [Figure 8] FIG. 8 shows the static friction coefficients of PVA and HEMA-MAA hydrogels obtained with the 2D bench setup of FIG. [Figure 9] FIG. 9 is a diagram of an embodiment of the device placed inside the birth canal and on the baby's head during the second stage of labor. [Figure 10] FIG. 10 shows (A) a perspective view of a hydrogel containing a reinforcing mesh, (B) a top view of a hydrogel containing a reinforcing mesh, and (C) a photograph of the warped mesh. [Figure 11] FIG. 11 is a drawing of the nylon mesh (29a) on the mold (before the mesh is molded into the hydrophilic polymer liquid). [Figure 12] FIG. 12 is a depiction of a sleeve according to one embodiment of the present disclosure. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS EXAMPLES

[0115] FIG 1 (A) shows a CAD cap (1a) of one embodiment of the present disclosure. The cap (1a) includes an opening (not shown) defined by a rounded (in cross section) rim (3). In FIG 1 (B), the cap (1b) is made from PVA hydrogel reinforced with nylon mesh (2). The cap is made by attaching (e.g., sewing) several sheets of reinforced hydrogel together, i.e., the cap also includes seams (5).

[0116] A birthing dummy (7) is shown in use by a birthing trainer in Figure 2. The head of the training dummy in the birthing dummy's birth canal is covered by a cap (1) in one embodiment. The cap is inserted into the birth canal and over the baby's head to assist in the delivery of the training dummy before the baby's head emerges.

[0117] FIG. 3(A) shows a photograph of a PAAm hydrogel sheet with a nylon mesh. FIG. 3(B) shows a photograph of a hydrogel made from a HEMA-based copolymer (HEMA-MAA). FIG. 3(C) shows a photograph of a PVA hydrogel with a nylon mesh. The shiny appearance of the hydrogel is caused by water trapped in the pores of the hydrogel and mesh. In use, the hydrogel sheet is used to make a cap of one embodiment. Substitutions and variations within the scope of this disclosure will be apparent to those skilled in the art. For example, the hydrogel can be made from polyacrylamide, polyvinyl alcohol (PVA), polyacrylamide (PAAm), HEMA-based copolymers, polyethylene glycol (PEG), polydimethylsiloxane (PDMS), or mixtures thereof, can include a water-based lubricant, and synthetic polymer fibers can form a non-porous layer.

[0118] In FIG. 4(A) a "2D" bench setup for measuring sliding friction is shown. Tribological tests to determine the friction coefficient of hydrogels are performed using a Biotribometer machine (PCS Instruments). The machine is characterized by a moving top element that slides against a fixed bottom plate with a specific load applied. The tests involve fixing two materials against the top arm (6) and bottom plate (22) to determine the friction coefficient of a suitable tribosystem that includes the two materials, for example a skin mimic (SynDaver®) (16) and a vagina mimic material (20) from SynDaver®. The vagina mimic material (20) from SynDaver® is applied against the bottom plate (22) while the skin mimic (16) is applied against the specimen holder (10) to more closely simulate an in vivo scenario. A hydrogel sample (18) is placed between the two skin mimics (16, 20) and allowed to slide freely. For example, an applied load (12) of 1 N, a stroke length of 20 mm, and a speed of 0.5 mm / s is used to evaluate the effective friction coefficient of the system. (4) corresponds to the actuation system, and (6) corresponds to the actuation arm.

[0119] Figure 4(B) summarizes the experimental results obtained using the 2D bench setup. The results clearly show that placing a hydrogel, such as PVA, between the "vaginal tissue" and the "skin" significantly reduces the static / sliding friction.

[0120] FIG. 5 shows that the greater the force applied to the specimen tissue, the smaller the coefficient of friction becomes when the hydrogel of an embodiment is present.

[0121] Figures 6(A) and 6(B) show a 3D'-birth-simulator setup (8) with an artificial head (9) covered with synthetic skin tissue positioned in a birth canal (11) lined with synthetic vaginal tissue. The simulator is used to measure the amount of energy required to slide the baby's head (9) through the birth canal (11) as well as allowing the user to measure the average steady state force. (13) corresponds to the position of the force transducer (not shown), (15) corresponds to the two removable alignment beams, and (17) corresponds to the actuation platform.

[0122] 7(A) and 7(B) show that the introduction of the various prototypes into a 3D'-birth-simulator setup reduces the energy required to slide the head through the birth canal by approximately 40%.

[0123] Figure 8 shows the static friction coefficients of hydrogels made with PVA and separate hydrogels made with HEMA-MAA (poly(2-hydroxyethyl methacrylate / methacrylic acid). The static friction coefficients were obtained using the 2D' bench setup described above. The HEMA-based hydrogels have a friction coefficient that is more than six times smaller than PVA.

[0124] Figures 10(A) and 10(B) show an example of a nylon mesh (29) embedded within a hydrogel (30). Figure 10(C) shows a photograph of an example of a nylon warp knit mesh.

[0125] Figure 12 shows a sleeve (31) according to one embodiment of the present disclosure. The sleeve (31) includes a first opening (35) and a second opening (39). The first opening (35) is defined by a first rounded rim (33) and the second opening (39) is defined by a second rounded rim (37).

[0126] Example 1 - Preparing a 15% PVA Hydrogel Cap Containing a Mesh

[0127] material Poly(vinyl alcohol) "PVA" (146,000-186,000g mol -1 , CAS:9002-89-5) and deionised water were supplied by Sigma-Aldrich UK. Nylon (warp knit) mesh. Beakers made from borosilicate glass were used as they can withstand the high temperatures and pressures they will be exposed to.

[0128] Examples of content amounts are listed in Table 1. The total weight can be adjusted depending on the size of the product being molded.

[0129] Table 1 - Calculated weights for PVA, scale [up or down] as desired. TIFF2025503329000004.tif21134

[0130] protocol: 1. Place nylon (warp knit) mesh inside the mold. 2.Measure out the DI water and PVA powder ingredients and place them into separate beakers. 3. Place the 15% PVA mixture in a high temperature pressure cooker or equivalent and set on high for 1 hour, stopping the cooker and mixing by hand every 20 minutes. 4. This means after 20 minutes, stop the cooker, remove the beaker, mix the solution thoroughly by hand, i.e. with a metal spatula or some equivalent (not plastic as it will melt), and place it back in the cooker, set on "high" for another 20 minutes, remove, mix by hand, etc., for a total cooking time of approximately 1 hour. After 1 hour of cooking time, the final solution should be clear, transparent (all PVA particles should be dissolved) and highly viscous. If not, continue repeating the cooking and mixing cycle until the correct solution is achieved. If the solution is gelatinous, it is either because the solution was not heated enough to dissolve all the PVA particles or the manual mixing was insufficient. 5. Take care to avoid excessive evaporation during the process; if a conical flask is used, the screw cap should be loosely fitted, and if an open flask is used, aluminum foil should be placed to cover the flask opening. 6. While it is boiling, immediately remove it from the pressure cooker, pour 15% PVA into the mold and close the mold. 7. Allow to cool and stabilize for 30 minutes. 8. Place in the freezer (approximately -25°C) for 18 hours (or overnight). 9. Thaw at 4°C (in the refrigerator) for 4 hours. Allow samples to come to room temperature (1 hour). 10. Remove from mold and allow to hydrate in deionized (DI) water for approximately 24 hours.

[0131] Example 2 - Fabricating a HEMA-MAA Hydrogel Sleeve Containing a Mesh

[0132] material 2-Hydroxyethyl methacrylate "HEMA", methacrylic acid "MAA", ethylene glycol dimethacrylate "EGDMA", 2,2´-azobis(2-methylpropionamidine) dihydrochloride "Azobis" (from Sigma-Aldrich UK), and deionized water "DI Water". Nylon (warp knit) mesh.

[0133] equipment Weighing scale, weighing paper, spatula, borosilicate glass beaker with plastic screw lid, magnetic stir bar, magnetic stirrer, plastic Petri dish, ultrasonic bath, nitrogen gas, chemical fume hood, UV curing machine (12W LED UV at 365nm).

[0134] Examples of ingredients are listed in Table 2. The total weight can be adjusted depending on the size of the product being molded.

[0135] Table 2 - Calculated weights for HEMA-MAA gel, scale [up or down] as desired. TIFF2025503329000005.tif36136

[0136] protocol: 1. Place nylon (warp knit) mesh inside the mold. 2. Weigh DI water directly into a glass beaker. Measure all ingredients and pour into the water in the beaker. Be careful not to breathe into the monomer powder / MAA. 3. Place a magnetic stirrer in the beaker, place a lid on the beaker, and turn on the magnetic stirrer to stir at room temperature at a fast but steady rate until the contents are dissolved (clear and transparent solution), and then leave to stir for an additional 30 minutes. 4. Deoxygenate the solution by nitrogen bubbling for 30 minutes and ultrasonic bath for 30 minutes. 5. Pour the molten hydrogel solution into the mold. 6. Place the mold under UV light until the solution solidifies (time depends on sample thickness). 7. Submerge the hydrogel with mold in an excess amount of DI water (in this example, greater than 2 L) for at least 48 hours. 8. Remove the formed hydrogel from the mold. 9. Wearing gloves, drain the water containing the unreacted monomer and rinse the HEMA-MAA sample several more times with water.

[0137] Example 3 - Fabricating a PAAm hydrogel cap containing a mesh

[0138] material Acrylamide, N,N'-methylenebis(acrylamide) "Bis", 2,2'-azobis(2-methylpropionamidine) dihydrochloride "Azobis" (from Sigma-Aldrich UK) and deionized water "DI Water".

[0139] equipment Weighing scale, weighing paper, spatula, borosilicate glass beaker with plastic screw cap, magnetic stir bar, magnetic stirrer, plastic Petri dish, ultrasonic bath, nitrogen gas, chemical fume hood, UV curing machine (12W LED UV at 365nm). Nylon (warp knit) mesh.

[0140] Examples of ingredients are listed in Table 3. The total weight can be adjusted depending on the size of the product being molded.

[0141] Table 3 - Calculated weights for PAAm gel, scale [up or down] as desired. TIFF2025503329000006.tif31136

[0142] protocol: 1. Place nylon (warp knit) mesh inside the mold. 2. Weigh DI water directly into a glass beaker. Measure all ingredients and pour into the water in the beaker. Be careful not to breathe into the monomer powder / MAA. 3. Place a magnetic stirrer in the beaker, place a lid on the beaker, and turn on the magnetic stirrer to stir at room temperature at a fast but steady rate until the contents are dissolved (clear and transparent solution), and leave to stir for an additional 30 minutes. 4. Deoxygenate the solution by nitrogen bubbling for 30 minutes and ultrasonic bath for 30 minutes. 5. Pour the molten hydrogel solution into the mold. The solution has a low viscosity to make it easier to pour into more complex molds. 6. Place the mold under UV light until the solution solidifies (time depends on sample thickness). 7. Submerge the hydrogel with mold in an excess amount of DI water (in this example, greater than 2 L) for at least 48 hours. 8. Remove the formed hydrogel from the mold. 9. Wearing gloves, drain the water containing the unreacted monomer and rinse the PAAm sample several more times with water.

[0143] Example 4 - Methods of the Disclosure Section 1. A method of making a device for assisting childbirth, comprising molding a hydrogel solution into the device for assisting childbirth. Section 2. The method of section 1, wherein the hydrogel solution comprises synthetic polymer fibers. Section 3. A method of making a device for assisting childbirth, comprising molding a hydrogel solution containing synthetic polymer fibers into the device for assisting childbirth. Section 4. The method of any of sections 1-3, wherein molding includes casting a hydrogel solution to create a cast comprising the hydrogel solution and synthetic polymer fibers, initiating hydrogel formation, and solidifying the cast to form a device for assisting childbirth. Section 5. A method of assisting a pregnant woman in childbirth comprising placing a device of the present disclosure over the baby's head in the subject's birth canal to assist in childbirth. Clause 6. The method of clause 5, wherein placing the device on the baby's head in the birth canal includes folding the crown or sleeve so that there is a double layer of reinforced hydrogel between the baby's head and the birth canal. Clause 7. A method according to claim 5 (clause 5) or claim 6 (clause 6), wherein the device is placed on the baby's head while the baby's head is in suboblique (well flexed) or submental bregmatic (super flexed facial position). Section 8. A method of assisting a pregnant woman in giving birth, particularly by preventing labor arrest, comprising using a device of the present disclosure to line at least a portion of the birth canal or to cover at least a portion of the baby in the birth canal during birth.

Claims

1. a hydrogel membrane for covering at least a portion of the baby in the birth canal and / or for lining at least a portion of the birth canal during childbirth; Devices for assisting childbirth, including

2. 2. The device of claim 1, wherein the part of the baby is the baby's head, the baby's neck, the baby's torso, or the baby's legs.

3. the hydrogel membrane comprises or is in the shape of a crown to be placed over the baby's head, the crown having an opening for receiving the baby's head; The device of claim 1 .

4. The device includes a rounded rim, The device of claim 1 .

5. The rounded rim defines the opening or the rounded rim defines the entire periphery or edge of the hydrogel membrane. The device of claim 4.

6. the rounded rim is made from or comprises a hydrogel; and / or The rounded rim is made of or comprises a high friction material having a higher coefficient of friction than the hydrogel membrane. The device of claim 4.

7. The rounded rim is made from or contains the same hydrogel as the crown or the hydrogel membrane. The device of claim 4.

8. The hydrogel membrane is reinforced with synthetic polymer fibers. The device of claim 1 .

9. The hydrogel membrane comprises a water-based lubricant or an oil-based lubricant. The device of claim 1 .

10. The device is a cap and the circumference of the opening is at least 24 cm. The device of claim 1 .

11. the device being a sleeve including a first rounded rim defining a first opening at one end and a second opening at the other end; the circumference of the first opening is less than 26 cm and the circumference of the second opening is greater than 28 cm, or the circumference of the first opening and the second opening is greater than 28 cm; The device of claim 1 .

12. the hydrogel membrane is biocompatible; The device of claim 1 .

13. The hydrogel membrane is made of one or more polymers selected from the group consisting of PVA, PEG, PAAm, HEMA copolymers and PDMS; The device of claim 1 .

14. The device of claim 1 , wherein the hydrogel membrane is made from a PVA, PAAm, or HEMA copolymer.

15. The synthetic polymer fibre is a woven fabric; The device of claim 8.

16. The synthetic polymer fibers form a mesh, the mesh being an open mesh, a filter mesh, a woven mesh or a warp knit mesh. The device of claim 8.

17. the mesh is a warp knit mesh; 17. The device of claim 16.

18. The synthetic polymer fibers are made from or comprise one or more polymers selected from the group consisting of polyamide, polyacrylonitrile, polyester, polypropylene, polybutester, polyurea, and polyurethane; The device of claim 8.

19. The synthetic polymer fibers are made from or include polyamide, and the synthetic polymer fibers are made from or include nylon; The device of claim 8.

20. The hydrogel membrane has a coefficient of friction of less than or equal to 0.5 (according to the 2D bench setup); The device of claim 1 .

Images