Artificial uterine system and method for the production thereof

Abstract

The invention relates to an artificial uterine system comprising a fetal chamber (1) having an interior (1a) which is delimited by at least one flexible inner wall (1b), and having an opening (1l), through which a fetus is able to be introduced into the interior (1a), and having an inflow connection and an outflow connection (1i) via which artificial amniotic fluid is able to be passed through the interior (1a), and a cover (1f) by means of which the opening (1l) of the fetal chamber (1) is able to be closed, and which has an umbilical cord feedthrough (1g) through which the umbilical cord of a fetus is able to be passed, wherein the fetal chamber (1) has a flexible outer wall (1c) arranged around the inner wall (1b), and between the inner wall (1b) and outer wall (1c) an outer space (1d) is formed which has at least one port (1j), wherein a fluid is able to be introduced into the outer space (1d) or is able to be removed from the outer space (1d) via the at least one port (1j). The invention also relates to a method for producing such a fetal chamber.

Description

[0001] RWTH Aachen

[0002] Artificial uterine system and methods for its manufacture

[0003] The invention relates to an artificial uterine system comprising a fetal chamber with an interior space enclosed by at least one flexible inner wall, in particular by a single inner wall without edges or corners, and with an opening, preferably an upper opening, through which a fetus can be inserted into the interior space, and with an inlet and an outlet connection through which artificial amniotic fluid can be passed through the interior space, and further comprising a lid with which the opening of the fetal chamber can be closed, and which has an umbilical cord passage through which the umbilical cord of a fetus can be passed.

[0004] The invention also relates to a method for manufacturing a fetal chamber of such an artificial uterine system.

[0005] An artificial uterine system of this type is known in the prior art, e.g. through publication EP 3 310 316 B1.

[0006] Such systems are used when a very premature fetus needs to be cared for outside the natural amniotic sac. For this purpose, the fetus lies in the fetal chamber of such a system, is surrounded by artificial amniotic fluid, and artificially supplied with oxygen-enriched blood via the natural umbilical cord, which is routed out of the system through the umbilical cord opening in the lid.

[0007] The problem with such systems is that the natural environment of a fetus has so far only been inadequately replicated in the artificial womb system.

[0008] It is therefore an object of the invention to improve such an artificial uterine system in such a way that a better replica of the natural environment is achieved, preferably wherein a natural growth of the fetus and amniotic sac can be replicated in the artificial uterine system, further preferably wherein a replica of the mother's muscle structures is also achieved.

[0009] It is also a task to provide a simple method for producing a fetal chamber that enables the aforementioned replica.

[0010] This problem is solved according to the invention in that, in an artificial uterine system of the type mentioned above, the fetal chamber has a flexible outer wall arranged around the inner wall, in particular a single outer wall without edges or corners, and an outer space is formed between the inner wall and the outer wall, which has at least one connection, preferably an inlet and an outlet connection, wherein a fluid can be filled into or removed from the outer space via the at least one connection.

[0011] This makes it possible to guide artificial amniotic fluid through the interior of the fetal chamber and its connections, while the fluid in the external space can exert pressure on the interior depending on the volume of fluid contained within, thereby allowing artificial amniotic fluid to be pushed out of the interior or drawn into it.

[0012] It is preferable to provide that the wall thickness of the outer wall is greater than the wall thickness of the inner wall. This results in greater flexibility in the inner wall, even if the inner and outer walls are made of the same material.

[0013] Preferably, the inner wall and outer wall are made of the same material, in particular an elastomer, preferably silicone.

[0014] The amniotic fluid circulation preferably forms a reservoir for receiving or releasing amniotic fluid. The volume of the interior can thus be influenced by the volume of the exterior space, allowing the interior to be adapted to the developmental stage of the fetus within. This enables the artificial growth of the interior, creating an artificial amniotic sac, as the fetus increases in size. The invention thus prevents the need to transfer a developing fetus to a different artificial uterine system as it grows.

[0015] A preferred embodiment provides that the inner wall and the outer wall are integrally joined in the area of ​​a collar surrounding the opening of the fetal chamber, to which the lid can be attached. This can be achieved, for example, if the inner wall of the fetal chamber and the outer wall are manufactured simultaneously and together.

[0016] This is preferably provided in an inventive method for producing a fetal chamber which has an interior space with an opening surrounded by a collar and which has an outer wall surrounding the inner wall and defining an outer space, in particular which has the features to be suitable for a system of the type named in this description, wherein, according to the invention, a mold is provided in which a first cavity defining the interior space and the inner wall and a second cavity defining the outer space and the outer wall are arranged opposite each other around a third cavity representing the collar and its opening edge.

[0017] Preferably, this provides a casting mold that represents a negative mold of the fetal chamber in a state in which the interior space is turned outwards from the exterior space at the opening plane and / or at the collar.

[0018] Furthermore, according to the invention, a liquid casting agent, in particular an elastomer, preferably silicone, forming the walls and the collar, is poured into the cavities. This agent is distributed onto the cavity walls by pivoting the mold and solidifies, in particular through vulcanization and / or polymerization. After the casting agent has solidified, the resulting form is removed from the mold by opening it. To form the fetal chamber, the inner wall formed in the first cavity is inverted into the space, in particular the future outer space, which is surrounded by the outer wall formed in the second cavity. The method thus makes it possible to produce the fetal chamber in a preform that can be demolded from a mold and is subsequently transferred into the final form by the aforementioned inversion, particularly for which no demoldable mold could be produced.

[0019] Preferably, the method provides that the desired wall thickness of the inner and / or outer wall is not achieved in a single step of filling and distributing the casting material, but rather that this process of filling and distributing the casting material is repeated several times, particularly to successively increase the wall thickness. Between the multiple filling and distributing steps, the excess casting material is drained from the mold to achieve solidification at the desired layer thickness.

[0020] A time interval is observed between the steps, which allows sufficient solidification but is short enough to allow the next layer to bond to the previous one.

[0021] This time is also referred to as the pot life of the casting compound used and preferably means the time available for processing the casting compound. In particular, the reactions that cause solidification are not completely finished within this time. Preferably, a layer can still bond to a previous one during this time because there is still the possibility that the casting compound of the later layer can react with the casting compound of the earlier layer.

[0022] In a preferred further development, it is provided that the casting agent is distributed successively in different cavities by swiveling it onto the respective cavity wall, in particular first being distributed successively in the first and second cavities and then the wall areas formed in the first and second cavities being connected by distributing the casting agent in the third cavity.

[0023] This allows for different layer thicknesses to be achieved in the first and second cavities, especially if the wall thickness in each cavity is built up successively as described above. For example, the layer thickness of the future outer wall can be greater, in particular twice as thick, as that of the future inner wall.

[0024] In a preferred further development, the inflow and outflow connections of the fetal chamber are each routed through the outer space and through the outer wall.

[0025] In terms of the process, a projection extending into the second cavity can be provided for each connection of the interior. Casting material is deposited onto this projection, which, after demolding, is cut open at the free end of the projection, forming a sleeve. A connection fitting cast in the first cavity can be inserted through this sleeve after the inner wall has been inverted into the outer space enclosed by the outer wall. The respective connection fitting can then be bonded to the sleeve, thus sealing the connection of the interior through the outer space and the outer wall.

[0026] The invention, preferably in conjunction with the aforementioned method, reveals that the fetal chamber forms a component, in particular a cast component, made of a flexible, especially elastic, material, the inner wall of which, at the region of the collar surrounding the opening, is folded / inverted from a position above the opening into a space surrounded by the outer wall, and the inlet and outlet connections, integrally molded onto the inner wall, are guided through the outer wall and sealed therein, in particular by a material bond, preferably by adhesive bonding or vulcanization. This enables the production of the inner wall and outer wall in a common mold, e.g., using the aforementioned method.

[0027] A further preferred embodiment provides that a flexible cover wall is arranged between the lid and the collar surrounding the opening, in particular having an umbilical cord opening. This cover wall, together with the lid, encloses a space above the interior, which can be pressurized by a fluid through the lid. Thus, a fetus lying in the interior is protected from the lid by the cover wall, which can therefore be made of a more rigid material than the inner and outer walls. Furthermore, the pressurization allows the volume enclosed between the lid and the cover wall to be varied and adjusted. This also influences the volume of the interior of the fetal chamber.

[0028] It is particularly preferred that the inner wall and / or the outer wall of the fetal chamber is adapted to the anatomical shape of a fetus in its lower region (in the direction of gravity). This is preferably achieved by having at least one, and preferably at least two, molded-in depressions in the lower region of at least the inner wall, and in particular also the outer wall. Such at least one, and preferably at least two, depressions create a receiving area adapted to the head and / or buttocks of the fetus and are preferably arranged at corresponding positions of the head and / or buttocks of the fetus.

[0029] Another possible embodiment involves the fetal chamber being located within, and in particular suspended within, a chamber, preferably gimbal-mounted, which can be filled with or is filled with a fluid. This achieves the compensation of the weight of the fetal chamber and the fetus, because the fetus floats within the fluid of the surrounding chamber. This prevents sagging of the inner wall sections under the weight of the fetus. The walls of the chamber are more rigid compared to the walls of the fetal chamber; in particular, the walls of the chamber are rigid walls, e.g., made of glass or plastic sheets.

[0030] A preferred embodiment, particularly as an alternative to arranging the fetal chamber in a surrounding chamber, provides that the inner and / or outer wall of the fetal chamber comprises at least one stiffening structure embedded in the material of the inner and / or outer wall. Such a stiffening structure can contribute to sufficient strength of the respective wall, in particular to such an extent that a surrounding chamber can be omitted, thus simplifying the system.

[0031] Such a stiffening structure has the further advantage of mimicking the course of the mother's muscle strands that surround and stabilize the natural amniotic sac. Advantageously, the course of such stiffening structures is adapted to the natural course of these muscle strands.A preferred further development provides that the at least one stiffening structure is formed from a material which has a higher modulus of elasticity than the material of the wall, and / or that the stiffening structure comprises reinforcing fibers which are embedded in the material of the wall, and / or that the stiffening structure is formed in a band shape with a progression starting from a starting point in a region of the collar surrounding the opening, downwards to a lower endpoint or back upwards to an upper endpoint in a second region of the collar surrounding the opening, in particular wherein the starting point and the upper endpoint or the first and the second region are opposite each other around the opening.

[0032] It is particularly preferred that at least one stiffening structure terminates in or passes through one of the aforementioned recesses. This particularly reinforces a point in the fetal chamber, especially its inner wall, which is subjected to stress from the buttocks or head of the fetus.

[0033] The invention is described in more detail using the figures.

[0034] Figures 1A and 1B show a possible embodiment of the system with a fetal chamber 1 surrounded by another chamber 2, in which the fetal chamber 1 floats in a fluid. The fetal chamber 1 itself is also shown in Figure 2. All features of the fetal chamber 1 in Figure 1 also apply to the fetal chamber in Figure 2.

[0035] The further chamber 2 comprises walls which may be attached to a frame 2a, which is preferably held by a supporting structure 2b. The chamber 2 may preferably include a cover 2c through which the fetal chamber 1 is accessible. The cover 2c includes an umbilical cord passage 2d.

[0036] The further chamber 2 preferably has at least one connection 2e for filling it with a fluid, draining it from it or passing it through the chamber.

[0037] The fetal chamber 1 has an interior space 1a, which is enclosed by an inner wall 1b. The inner wall 1b is preferably without corners or edges.

[0038] Preferably, the inner wall 1b is made of a flexible and / or elastic material, e.g., an elastomer, preferably silicone. The inner wall 1b thus effectively forms a bubble made of the selected material. The inner wall 1b is surrounded by an outer wall 1c, which defines an outer space 1d located between the outer wall 1c and the inner wall 1b. The outer wall 1c is also preferably free of corners and edges. The outer wall 1c is further preferably also made of a flexible and / or elastic material, e.g., an elastomer, preferably silicone. The outer wall 1c thus also effectively forms a bubble made of the selected material.

[0039] The inner wall 1b and the outer wall 1c are preferably joined in one piece at a collar 1e, which surrounds an opening through which a fetus can be placed into the interior 1a. The inner wall 1b and the outer wall 1c can also be two separate walls that are joined in the area of ​​the collar 1e, e.g., by clamping. For example, both walls 1b and 1c can each have a collar that are clamped together while lying on top of each other.

[0040] A cover 1f is clamped to the collar 1e. This cover closes off the interior space 1a at the top. The cover 1f has an umbilical cord opening 1g to allow the umbilical cord of a fetus to pass through it. A cover wall 1h, preferably made of an elastic and / or flexible material, particularly the same as that used for walls 1b and 1c, is clamped between the collar 1e and the cover 1f. This creates a pressurizable space between the cover 1f and the cover wall 1h, which separates the interior space 1a from the cover 1f. The space has, for example, a connection in the cover.

[0041] The interior space 1a has an inlet and an outlet connection 1i to allow artificial amniotic fluid to flow through the interior space 1a. The two connections 1i are preferably located on opposite sides.

[0042] In this embodiment, the outer chamber 1d also has an inlet and an outlet connection 1j to guide a fluid, in particular a liquid fluid, through the outer chamber 1d. The volume of fluid in the outer chamber 1d can influence the volume of the inner chamber 1a.

[0043] Figure 2 shows a fetal chamber 1, which, as shown in Figure 1, can be arranged in a surrounding chamber 2, but can also be used without the surrounding chamber 2. It has the lid 1f and the cover wall 1h (not shown here) with all the features described in relation to Figure 1.

[0044] This fetal chamber 1 of Figure 2 preferably has the same features as those described for Figure 1 and is preferably further developed by stiffening structures 1k. Except for the stiffening structures, but possibly also these, the fetal chamber 1 of Figure 1 preferably also has the same features as those described for the fetal chamber 1 of Figure 2.

[0045] These stiffening structures 1k are embedded in the inner wall 1b and / or outer wall 1c. In the process, this can be achieved by placing at least one stiffening structure 1k into the mold of the fetal chamber 1 before its production, thus embedding it in the formed walls 1b and / or 1c.

[0046] In the embodiment shown in Figure 2, several stiffening structures 1k can be seen. There are at least stiffening structures that run vertically in the inner wall 1b and / or outer wall 1c, preferably also at least one that runs transversely to the vertical direction, particularly in the area of ​​the opening 11.

[0047] Preferably, at least some of the vertically extending stiffening structures 1k terminate in or pass through recesses 1m, which are positioned at locations in the inner wall 1b and / or outer wall 1c where the head and / or buttocks of a fetus will lie. The upper ends of these vertically extending stiffening structures 1k then terminate in the region of the opening 11, preferably on opposite sides around the opening 11. In particular, the upper ends terminate in a horizontally extending stiffening structure 1k surrounding the opening 11.

[0048] In general, and independent of the designs shown here, stiffening structures 1k can be, for example, reinforcing fibers or strips of a material that has a different, in particular larger, modulus of elasticity than the material of inner wall 1b and / or outer wall 1c. Stiffening structures 1k can, for example, have an elongation (e.g., tensile strain) that is only 1 / 3 of the elongation of the material of walls 1b, 1c.

[0049] Figures 3A to 3D show several views of a mold 3 for the production of the fetal chamber. The mold 3 is preferably composed of several mold parts, e.g., by screwing them together. In the mold 3, a first cavity 3a, defining the interior 1a and the inner wall 1b, and a second cavity 3b, defining the outer space 1d and the outer wall 1c, are arranged opposite each other around a third cavity 3c, representing the collar 1e and its opening edge, as shown particularly in the sectional views of Figures 3b and 3c.

[0050] This preferably results in a negative mold of the fetal chamber 1 in a state in which the interior space 1a is turned outwards from the outer space 1d at the plane of the opening 11 and / or at the collar 1e. The mold can be multi-part, e.g., a separation can be made in the area of ​​the collar 1e or the third cavity 3c.

[0051] Here, in the first cavity 3a, features 3d can be seen which represent the negative form of the inlet and outlet connections 1i of the later interior space 1a. The second cavity 3b also has such features 3e, which represent the negative form of the at least one connection 1j, in particular the inlet and outlet connections 1j of the later exterior space 1d.

[0052] Additionally, in the second cavity 3b, a projection 3f is provided for each connection 1i of the interior 1a. This projection extends into the second cavity 3b, and during the manufacture of the fetal chamber, casting material is deposited onto this projection. After demolding, this material is cut open at the free end of the projection 3f, forming a sleeve through which a spigot of connection 1i, cast in the first cavity, can be inserted. This occurs after the inner wall 1b has been inverted into the outer space 1d, which is enclosed by the outer wall 1c. The spigot of connection 1i can then be bonded to the sleeve, thus sealing the respective connection 1i of the interior 1a through the outer space 1d and the outer wall 1c.

[0053] Preferably, to open the mold 3, a mold part with the first cavity 3a is separated at the collar area from a mold part with the second cavity 3b, after which the fetal chamber, which still needs to be inverted, can be removed from the mold 3. The cavity 3c is then preferably formed by opposing areas of the two connected mold parts. As symbolized in Figure 3C, the casting compound 4 poured into the mold 3 spreads onto the inner walls of the cavities 3a, 3b, 3c, e.g., by swiveling the mold, and forms the inner wall 1b, outer wall 1c, and the collar 1e. The casting compound 4 is only partially shown in Figure 3C and at a distance from the cavity wall that does not exist in reality; it is shown here only for the purpose of visualizing the deposited casting compound 4.

Claims

Patent claims 1. Artificial uterine system comprising a. a fetal chamber (1) i. with an interior space (1a) enclosed by at least one flexible inner wall (1b), in particular by a single inner wall (1b) formed without edges or corners, and ii. with an opening (11), preferably an upper opening (11), through which a fetus can be inserted into the interior space (1a), and iii. with an inlet and an outlet connection (1i) through which artificial amniotic fluid can be passed through the interior space (1a), and b. a lid (1f) i. with which the opening (11) of the fetal chamber (1) can be closed, and ii. which has an umbilical cord passage (1g) through which the umbilical cord of a fetus can be passed, characterized in that c. the fetal chamber (1) has a flexible outer wall (1c) arranged around the inner wall (1b), in particular a single outer wall (1c) without edges or corners, and d.An external space (1d) is formed between the inner wall (1b) and the outer wall (1c), which has at least one connection (1j), preferably an inlet and an outlet connection (1j), wherein the. at least one connection (1j) allows a fluid to be poured into or removed from the external space (1d).

2. System according to claim 1, characterized in that the inner wall (1 b) and the outer wall (1 c) are integrally connected in the area of ​​a collar (1 e) surrounding the opening (11) of the fetal chamber (1), to which the cover (1f) can be attached.

3. System according to one of the preceding claims, characterized in that the inlet and outlet connection (1 i) of the interior (1a) are each led through the exterior space (1d) and through the outer wall (1c).

4. System according to one of the preceding claims 2 or 3, characterized in that the fetal chamber (1) forms a component, in particular a cast component, made of a flexible, in particular elastic, material, the inner wall (1b) of which is folded into a space (1d) surrounded by the outer wall (1c) at the area of ​​the collar (1e) surrounding the opening (11), in particular from a position located above the opening (11), and the inlet and outlet connections (1i) integrally formed on the inner wall (1b) are guided through the outer wall (1c) and sealed in it, in particular by a material bond, preferably by bonding or vulcanization.

5. System according to one of the preceding claims, characterized in that a flexible cover wall (1 h) is arranged between the lid (1f) and the collar (1e) surrounding the opening (11), in particular having an umbilical cord passage which, together with the lid (1f), defines a space above the interior (1a) which can be pressurized by means of a fluid through the lid (1f).

6. System according to one of the preceding claims, characterized in that the inner wall (1b) and / or the outer wall (1c) of the fetal chamber (1) is adapted in the lower region to the anatomical shape of a fetus, in particular by at least one, preferably by at least two, depressions (1m) formed in the lower region of the wall, in particular the are arranged, at least essentially, in the head and buttocks position of a fetus placed in the interior.

7. System according to one of the preceding claims, characterized in that the fetal chamber (1 ) is located in a chamber (2), in particular is suspended in the chamber (2), preferably gimbal suspended, which can be filled with a fluid.

8. System according to one of the preceding claims, characterized in that the inner wall (1 b) and / or the outer wall (1 c) of the fetal chamber (1 ) comprises at least one stiffening structure (1 k) which is embedded in the material of the wall (1 b, 1 c).

9. System according to claim 8, characterized in that the at least one stiffening structure (1k) a. is formed from a material having a higher modulus of elasticity than the material of the wall (1b, 1c), and / or b. comprises reinforcing fibers embedded in the material of the wall (1b, 1c), and / or c. is formed in a band shape with a progression starting from a starting point in a region of the collar (1e) surrounding the opening (11), downwards to a lower endpoint or back upwards to an upper endpoint in a second region of the collar (1e) surrounding the opening (11), in particular wherein the starting point and the upper endpoint or the first and the second region are opposite each other around the opening (11), in particular wherein a stiffening structure (1k) terminates in or passes through a recess (1m) according to claim 7.

10. Method for producing a fetal chamber (1) having an interior space (1a) with an opening (11) surrounded by a collar (1e) and having an outer wall (1c) surrounding the inner wall (1b) and defining an outer space (1d), in particular for a system according to one of the preceding claims, characterized in that a. a mold (3) is provided in which a first cavity (3a) encompassing the interior space (1a) and the inner wall (1b) and a second cavity (3b) encompassing the outer space (1d) and the outer wall (1c) are arranged opposite each other around a third cavity (3c) representing the collar (1e) and its opening edge, in particular whereby the mold (3) represents a negative mold of the fetal chamber (1) in a state in which the interior space (1a) is turned out of the outer space (1d) at the opening plane and / or at the collar (1e), and b. a casting agent (4), in particular an elastomer, preferably silicone, forming the walls (1 b, 1 c) and the collar (1e), is poured into the cavities (3a, 3b, 3c), which is distributed on the cavity walls by swiveling the mold (3) and solidifies, in particular by vulcanization and / or polymerization, and c.After the casting medium (4) has solidified, the resulting form is removed from the mold (3) by opening it, and d. to form the fetal chamber (1 ), the inner wall (1b) formed in the first cavity (3a) is inverted into the space, in particular the later outer space (1 d), which is surrounded by the outer wall (1c) formed in the second cavity (3b).

11. Method according to claim 10, characterized in that step b) is carried out repeatedly, in particular for the successive increase of the wall thickness.

12. Method according to one of the preceding claims 10 or 11, characterized in that the casting agent (4) is distributed successively in different cavities (3a, 3b, 3c) by pivoting onto the respective cavity wall, in particular first being distributed successively in the first and second cavities (3a, 3b) and subsequently the wall areas formed in the first and second cavities (3a, 3b) are connected by distributing the casting agent (4) in the third cavity (3c).

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