Cranial remodeling orthosis with a hinge mechanism

Abstract

The object of the invention is a cranial remodeling orthosis with a hinge mechanism (4) comprising a front portion (1 ), a rear portion (2), at least one clamping mechanism (3) for removable connection of the front portion (1 ) and the rear portion (2) on one lateral side of the cranial remodeling orthosis, and, further, a hinge mechanism (4) for hinged connection of the front portion (1 ) and the rear portion (2) on the opposite lateral side of the cranial remodeling orthosis. The hinge mechanism (4) comprises a hinge (4a) of a flexible material housed in the front portion (1 ) and the rear portion (2)

Description

[0001] Cranial remodeling orthosis with a hinge mechanism

[0002] Technical Field

[0003] The present invention relates to a cranial remodeling orthosis with a hinge mechanism, in particular for the treatment of head deformations in newborns, infants and toddlers.

[0004] Background of the Invention

[0005] Cranial remodeling orthoses are used to secure or support the remodeling of the wearer’s head into the correct shape. These orthoses must be precisely adapted to the head of the particular wearer for both their comfort and the correct function of the cranial remodeling orthosis. For example, unwanted head deformations sometimes occur in newborns, infants, and toddlers (mostly due to flattening from lying in one position), which require prompt corrective treatment to correct the shape of the head. These deformations include so-called plagiocephaly, which is a defect in the symmetry of the head, so-called brachycephaly, which is a defect in the proportions of the head, or a combination of the two (referred to as asymmetrical brachycephaly), where the head exhibits both asymmetry and defective proportions. Plagiocephaly is manifested, for example, by asymmetrical flattening on the rear side of the head, prominence of the forehead on the side of the rear flattening, forward displacement of the ear on the side of the rear flattening, or asymmetry in facial alignment. Brachycephaly is manifested by a symmetrical flattening on the rear side of the head, an excessive width of the head, or a higher skull. The combination of these two types of deformation is then manifested by bilateral flattening of the rear side of the head, where one side of the head is flatter than the other, the forehead is displaced forward on the side of the greater flattening on the rear side of the skull, or the ear is displaced forward on the side of the greater occipital flattening.

[0006] These defects may be treated by wearing a cranial remodeling orthosis. Such an orthosis has an inner cavity to accommodate the head specifically designed to match the head shape the head should have at the end of treatment. Such an orthosis then directs the correction of the shape of the head during the course of growth. This means that the inner wall of the shell of the cranial remodeling orthosis is not in contact with the head in some places, so head growth is supported in these places, while in places where the inner wall of the shell of the cranial remodeling orthosis is in contact with the head, head growth is limited.

[0007] In the current state of the art, several kinds of cranial remodeling orthoses are known, differing in the manner in which the orthosis is applied and fixed to the head.

[0008] There are, for example, one-portion cranial remodeling orthoses that are made of one portion of material that is divided on one side by a gap running from top to bottom. This creates two free ends of the orthosis, which can be opened to open the whole orthosis such that it can be applied on the head. A disadvantage of this one-portion solution lies mainly in the fact that it does not provide uniform control over the correct position of the applied orthosis. For example, an undesirable displacement of the free ends of the orthosis up or down relative to each other may occur. In addition, a spatially distinctive strap is used to tighten both ends of the orthosis together, which is visually distracting.

[0009] There are also two-portion cranial remodeling orthoses that are more preferable for manufacture using 3D printing technology and that use clamping mechanisms on both lateral sides of the orthosis to connect the individual portions (front and rear). An example of such a solution is a cranial remodeling orthosis known as Talee by the Invent Medical company. The clamping mechanisms used, in combination with the shape guide arranged on the individual portions of the orthosis, provide uniform control over the correct position of the applied orthosis and, moreover, do not interfere with the visual appearance thereof. A disadvantage of this solution, however, lies in the more difficult manipulation when applying, or conversely, taking off the orthosis, as it is necessary to always fasten or unfasten both clamping mechanisms. Since both portions are completely separated while applying the orthosis (before they are connected by means of the clamping mechanisms), for example a portion of the orthosis may be dropped on the ground and the overall manipulation is more complicated.

[0010] Two-portion cranial remodeling orthoses, where both portions are riveted together at the top, allowing the front and rear portions to mutually open up and down, are also known. Such orthoses are not very comfortable, either in terms of wearing them or applying them on the head.

[0011] Another two-portion solution of the cranial remodeling orthosis is described in the patent document KR200437272 Y1 . This orthosis comprises a front and rear portion that are connected on one lateral side of the orthosis by a clamping mechanism (specifically using Velcro), and both portions are on the opposite lateral side of the orthosis connected by a hinge. This hinge allows both portions of the orthosis to be opened sideways apart from each other, thus simplifying the manipulation for applying the orthosis, or conversely, for taking it off. On the one hand, it is enough to fasten or unfasten only one clamping mechanism, and it is also advantageous that the individual portions of the orthosis remain connected by a hinge during their application, and thus there is no risk of dropping the portion on the ground in case of careless handling. A disadvantage of this solution, however, lies in the fact that said hinge is firmly attached to both portions of the orthosis, for example by rivets, screws, or adhesive, and it is therefore difficult to replace the hinge if necessary, or to disassemble the orthosis into individual separate portions, which may be required e.g. for space-efficient storage of the orthoses prior to their delivery to the customer. The hinge is made e.g. of stainless steel or plastic and is fixed on the outer side of the orthosis. It is therefore entirely visible from the outside, which interferes with the visual appearance of the orthosis and may be less comfortable during manipulation and use.

[0012] Therefore, it would be desirable to come up with a solution of a cranial remodeling orthosis that would allow for easy manipulation when applying or taking off the orthosis. The proposed solution also should not contain any element that would be visually distracting and should allow for complete separation of the individual portions of the orthosis if necessary. The cranial remodeling orthosis should also be suitable for manufacture by 3D printing. Summary of the Invention

[0013] The above shortcomings are eliminated to a certain extent by a cranial remodeling orthosis with a hinge mechanism comprising a front portion, a rear portion, at least one clamping mechanism for removable connection of the front portion and the rear portion on one lateral side of the cranial remodeling orthosis, and, furthermore, a hinge mechanism for hinged connection of the front portion and the rear portion on the opposite lateral side of the cranial remodeling orthosis. The essence of the cranial remodeling orthosis of the present invention lies in the fact that the hinge mechanism comprises a hinge made of a flexible material housed in the front portion and the rear portion.

[0014] The hinge means an element that allows for hinged connection of the front portion and the rear portion, i.e. an element that allows the front portion and the rear portion to be pivoted away from each other (opened) and the front portion and the rear portion to be pivoted back toward each other (closed). In the present invention, this mutual pivoting away I pivoting together movement of the front portion and the rear portion is enabled precisely because the hinge is made of a flexible material. Therefore, there is no need for the hinge to have a more complex structure or to be composed of a larger number of parts. The flexible material means a bendable material whose deformation (bending) allows the front portion and the rear portion, which are connected together by the hinge made of the flexible material, to move together. Preferably, however, this flexible material is not only bendable but also elastic. The flexible material of the hinge may be e.g. elastomer (Vulkollan, TPU, TPA, silicone rubber, etc.) or thermoplastic (PE, PP, CPP, ABS). Alternatively, the hinge may be implemented in the form of a metal spring strip. The manufacturing technology can also be chosen in accordance with the material. If the hinge is made e.g. of TPU, e.g. the 3D printing method may be used for its manufacture. If the hinge were made e.g. of Vulkollan, e.g. the laser or waterjet cutting method could be used for its manufacture.

[0015] In general, the hinge may be implemented in various shapes as long as it reliably performs the hinged connection function of the front and rear portion. However, preferably the hinge has a flat shape, which means that the thickness thereof is less than the other two dimensions thereof. Due to the flat shape, the hinge may be housed both in the front portion and the rear portion, which have relatively thin walls, and it can be embedded in these walls. Preferably, the hinge also has an elongated shape, which means that a first end, by which the hinge is removably housed in the front portion, and a second end, by which the hinge is removably housed in the rear portion, may be defined. The elongated shape of the hinge requires relatively little material for manufacturing, wherein there is no need for the hinge to have a width too large.

[0016] An advantage of the hinged connection on one lateral side of the cranial remodeling orthosis lies in the fact that although the cranial remodeling orthosis is made of two portions, it is characterized by ease of manipulation during its application on the wearer's head or when taking it off. The individual portions remain connected by the hinge (unless the user decides to disassemble this connection as well and preferably remove the hinge), and there is no risk of e.g. dropping one of the portions on the ground in case of careless handling. However, pivoting portions away, or conversely, toward each other is only possible if the clamping mechanism on the opposite lateral side of the cranial remodeling orthosis is unfastened. The clamping mechanism may be arranged e.g. on the right lateral side of the cranial remodeling orthosis, while the hinge mechanism may be located on the left lateral side of the cranial remodeling orthosis. Alternatively, the sides may be reversed, i.e. the clamping mechanism may be arranged, e.g., on the left lateral side of the cranial remodeling orthosis and the hinge mechanism may be located on the right lateral side of the cranial remodeling orthosis.

[0017] The clamping mechanism may be implemented in various ways as long as the given embodiment allows for a removable connection of the front portion and the rear portion. A possible embodiment of the clamping mechanism comprises e.g. a lever rotatably fixed to one of the portions, a loop fixed to the lever, and a slot for the loop located on the other one of the portions. To connect the front portion and the rear portion by means of the clamping mechanism, the loop is inserted into the slot for the loop and subsequently the lever is rotated toward the front portion. Alternatively, however, any other embodiment of the clamping element known from the state of the art may be used, e.g. using Velcro, straps, various buckles, etc.

[0018] The front portion and the rear portion are preferably manufactured by 3D printing as rigid shells. The 3D printing allows for the manufacture of the cranial remodeling orthosis parts tailored to the specific patient such that the assembled cranial remodeling orthosis allows for treatment of head deformations as needed. Alternatively, the front portion and the rear portion may also be manufactured in other ways, e.g. using plastic forming technology.

[0019] Housing the hinge in the front portion and the rear portion ensures that at least a part of the hinge is located inside the front portion and the rear portion. The hinge housed in this manner thus improves the visual appearance of the cranial remodeling orthosis and does not interfere with its manipulation. To house the hinge, the cranial remodeling orthosis comprises recesses for the hinge, wherein the front portion comprises at least one recess for the hinge adapted in shape to house the hinge and the rear portion also comprises at least one recess for the hinge adapted in shape to house the hinge. These recesses for the hinge may e.g. have the shape of a cavity in which the hinge may be housed so as to be surrounded by walls of the corresponding portion of the orthosis, including from the lateral sides. Alternatively, however, these recesses for the hinge may have such a shape that after the hinge is housed, they do not cover the hinge completely but the hinge is visible from the lateral side. However, in such a case it is desirable for the hinge to not protrude beyond the outer wall of the corresponding portions of the cranial remodeling orthosis. Preferably, the recesses for the hinge have a shape precisely complementary to the shape of the hinge. Alternatively, the recesses for the hinge do not have to have a shape precisely complementary to the shape of the hinge if this shape allows for the hinge to be housed in the recess for the hinge. It is preferable for the recesses for the hinge to have a shape complementary at least to the shape of the end parts of the hinge.

[0020] The hinge is preferably housed in the front portion and the rear portion removably. Due to the fact that the hinge is housed in the front portion and the rear portion removably, the entire cranial remodeling orthosis may be disassembled into individual parts and, above all, the hinge may be replaced with another one if necessary. For example, in this way it is possible to replace a damaged hinge with a new one or to replace a hinge of a certain material with a hinge of a different (e.g. more elastic) material, easily and without the use of any tools. To remove the hinge from the front portion and the rear portion, it is generally necessary to overcome only the frictional force between the hinge and the corresponding recess for the hinge, and possibly also the force of the form -fit housing - in case the hinge comprises shape protrusions or shape recesses, as will be described below. The recesses for the hinge may be arranged in the contact surfaces of the front portion and the rear portion, by which the front portion and the rear portion abut each other when connected. Preferably, both recesses for the hinge form together a space for housing the entire hinge.

[0021] Alternatively, the hinge may be fixed when housed in the front portion and the rear portion, e.g. by means of adhesive applied between the hinge and the recess for the hinge or mechanically (by a rivet, screw connection). The hinge may also be fixed in only one portion, while it may be housed removably in the other portion. Such embodiment retains the possibility to separate the front portion and the rear portion also on this lateral side of the cranial remodeling orthosis.

[0022] When housed in the front portion and the rear portion, the hinge is preferably completely embedded in the front portion and the rear portion. In such an embodiment, the hinge is not visible when the cranial remodeling orthosis is viewed from either the outer or the inner side. For example, only the stop may be visible, if the hinge mechanism includes one, as will be described below. Embedding the entire hinge in the front portion and the rear portion further improves the visual appearance of the cranial remodeling orthosis and ensures that the hinge does not interfere with the manipulation of the orthosis.

[0023] The front portion and the rear portion are preferably provided with a shape guide to precisely align the relative position of the front portion and the rear portion. Thanks to the shape guide, it is possible to fit the front portion and the rear portion into each other to create a complete cranial remodeling orthosis allowing for treatment tailored to the individual patient. The shape guide prevents e.g. the front portion and the rear portion from rotating relative to each other. The shape guide may be implemented e.g. to comprise several shape cavities formed in one of the portions and several shape protrusions arranged on the opposite portion. The shape protrusions fit by their shape into the shape cavities and are located in positions corresponding to the positions of these shape cavities. In various alternative embodiments, the specific shape or number of the shape protrusions and shape cavities may vary. Alternatively, the shape guide may comprise only one shape protrusion and shape cavity, or the shape protrusion and the shape cavity may be arranged along the entire length of the contact surface of the front portion or the rear portion, or along a substantial part of this contact surface.

[0024] The hinge is preferably provided with a stop, wherein when the hinge is housed in the front portion and the rear portion, at least part of the stop is located between the edges of the front portion and the rear portion. The presence of the stop material in the place between the edges of the front portion and the rear portion prevents the edges from rubbing against each other, which would otherwise occur when opening the cranial remodeling orthosis using the hinge mechanism. Thanks to the stop, these edges do not come into direct contact with each other when opening, but instead remain in contact with the stop. The stop may be made of the same flexible material as the hinge itself, or it may be made of a material different than the hinge. However, the stop should be made of a material that is softer than the material of the front portion and the rear portion.

[0025] At least one of the front portion and the rear portion preferably comprises a recess for the stop, wherein when the hinge is housed in the front portion and the rear portion, at least a part of the stop is located in the recess for the stop. Thanks to the above mentioned recesses for the stop, it is possible to position the stop so that it does not interfere with the precise alignment of the position of the front portion and the rear portion. The stop as well as the recess for the stop may have different shapes, wherein the shape of the recess for the stop preferably corresponds to the shape of at least the part of the stop to be housed in the recess for the stop. The stop may have e.g. the shape of a thin partition in the vicinity of the hinge, and at a certain distance from the hinge, its shape may widen into a widened part. The shape of the recess for the stop may thus correspond to e.g. the shape of this widened part. As already indicated, the recess for the stop does not have to be created in both portions of the cranial remodeling orthosis but may alternatively be created only in the front portion or only in the rear portion depending on the shape of the stop. Preferably, the stop has such a shape and dimensions that when housed in the recess for the stop, its outer surface is aligned with the outer surface of the front portion and the rear portion. The stop thus preferably does not protrude outward from the cranial remodeling orthosis.

[0026] Preferably, the stop is an integral part of the hinge. In other words, this means that the stop forms a single integral part with the hinge, which is efficient from a manufacturing standpoint, as both components may be manufactured simultaneously, e.g. using a 3D printing method. The stop extends integrally perpendicularly from the outer side of the hinge, i.e. , the side of the hinge that is oriented away from the cranial remodeling orthosis. Therefore, the stop is typically made of the same material as the hinge. Alternatively, if the manufacturing technology permits, the stop may be made of a different material than the hinge from which it extends, even though here the stop and the hinge form one integral part.

[0027] The stop is preferably slid onto the hinge. This alternative version to the integral version described above allows the hinge and the stop to be separated and, e.g., only one of these components to be replaced if necessary. In addition, this allows for an easier combination of the materials from which the hinge and the stop are made and, if necessary, for selection a different manufacturing technology for each of these components. The hinge may be made, e.g., from so-called Vulkollan, a high-elasticity polyurethane elastomer, and preferably from a flat polyurethane plate by laser or waterjet cutting. At the same time, the stop may be made, e.g. from TPU, preferably using 3D printing technology. Alternatively, the hinge and the stop may be made from other materials or using other manufacturing technologies. For the purposes of sliding onto the hinge, the stop comprises an eye, a slot, or other element adapted in shape to slide onto the hinge. Simultaneously, the shape of the stop and the hinge and their mutual friction ensure that the stop does not slip off the hinge without the application of required force. Slipping of the stop from the hinge may also be prevented by the elasticity of the stop or by shape projections that the hinge may contain and by which the stop may also stop.

[0028] The stop preferably comprises a suspension for suspending from the front portion and / or the rear portion. The stop in both integral and sliding versions as explained above may be provided with such a suspension, wherein due to the suspension, the stop is additionally fixed to the front portion or the rear portion, which improves the compactness of the orthosis. The stop may therefore comprise, e.g., only one suspension for suspending from the front portion or the rear portion, or alternatively it may comprise two suspensions (or one common suspension) for suspending from both the front portion and the rear portion. The suspension may be implemented, e.g., as an elastic loop that can be stretched into the slot for a locking element, which will be described below. Alternatively, however, the suspension may be implemented differently, e.g. as a cable ending with a hook, and may be suspended from or hooked to a different part of the front portion or the rear portion other than the slot for the locking element.

[0029] The hinge mechanism further preferably comprises a locking element for holding the front portion and the rear portion together. This locking element therefore counteracts the force that would push the front portion and the rear portion away from each other and that could cause their undesired separation. For example, the force acting on the rear portion in the direction away from the front portion (or the force acting on the front portion in the direction away from the rear portion) could be so great that it could overcome the frictional force between the hinge and the recess for the hinge. The locking element prevents this. The force counteracting the force that would push the front portion and the rear portion away from each other may be provided, e.g., by the locking element being made of an elastic material.

[0030] The locking element is preferably a loop, wherein at least one of the front portion and the rear portion comprise a slot for the locking element. The loop may be implemented, e.g., as an elastic circumferential ring, so-called O-ring, but may also be of a different shape or generally implemented in a different way. The shape, length, crosssection, or number of slots for the locking element may also vary. For example, a single U-shaped slot for the locking element may be formed in both the front portion and the rear portion, wherein the open ends of the individual slots for the locking element may be accessible from the same sides as the recess for the hinge and the recess for the stop. In the assembled state of the cranial remodeling orthosis, the two slots for the locking element are then connected to form one common slot for the locking element. Alternatively, however, the slot for the locking element may be formed only in the front portion and the locking element is attached to the rear portion in a different way, or vice versa. Alternatively, multiple slots for the locking element may be formed in each portion. Alternatively, the locking element may not be inserted into the slot, but may be inserted, hooked, or otherwise attached to a different part of the front portion or the rear portion.

[0031] The hinge preferably comprises at least one shape projection and / or at least one shape recess. The shape projections or shape recesses ensure reliable housing of the hinge in the front portion and the rear portion, specifically in the recess for the hinge. The shape projection means a part of the hinge that projects outward from the hinge, e.g., a part that widens the hinge or that, e.g., increases its height. The shape recess means a part of the hinge that is formed inward within the hinge, thus e.g. the part that narrows the hinge or that, e.g., reduces its height. The shape recess may also be a notch, e.g., a notch running in the longitudinal direction of the hinge from its individual ends. With respect to the shape of the hinge, a shape of the recess for the hinge is also proposed, wherein the shape of the recess for the hinge copies the shape of the hinge with these shape projections or shape recesses. In other words, it means that the recesses for the hinge comprise elements that are complementary in shape to the shape projections or the shape recesses. This creates a mechanical connection that holds the hinge firmly in the recess for the hinge, but when a certain force is exerted (to overcome friction and also the engagement of the shape projections and shape recesses with the corresponding shape-complementary elements), the hinge may be removed from the recess for the hinge and possibly replaced.

[0032] Description of Drawings

[0033] A summary of the invention is further clarified using exemplary embodiments thereof, which are described with reference to the accompanying drawings, in which: fig. 1 shows a cranial remodeling orthosis in the first exemplary embodiment of the present invention in an assembled state, in a side view and with the plane of section A indicated. fig. 2 shows the cranial remodeling orthosis in the first exemplary embodiment of the present invention in exploded and side view, fig. 3 shows the cranial remodeling orthosis in the first exemplary embodiment of the present invention in the assembled state and in a spatial view of the front portion, fig. 4 shows the cranial remodeling orthosis in the first exemplary embodiment of the present invention in exploded and spatial view of the front portion, fig. 5 shows the cranial remodeling orthosis in the first exemplary embodiment of the present invention in a section A-A, fig. 6 shows the cranial remodeling orthosis in the second exemplary embodiment of the present invention, in exploded and side view, fig. 7 shows a detail of the hinge of the second exemplary embodiment in a side view, fig. 8 shows a detail of the hinge of the second exemplary embodiment in a spatial view and with the stop shown separately from the hinge, and fig. 9 shows a detail of the hinge of the second exemplary embodiment in a spatial view and with the stop fitted. fig. 10 shows the cranial remodeling orthosis in the third exemplary embodiment of the present invention, in the assembled state and in a side view, fig. 11 shows the cranial remodeling orthosis in the third exemplary embodiment of the present invention, in exploded and side view, fig. 12 shows the cranial remodeling orthosis in the third exemplary embodiment of the present invention in the assembled state and in a spatial view of the front portion, fig. 13 shows the cranial remodeling orthosis in the third exemplary embodiment of the present invention, in exploded and spatial view of the front portion.

[0034] Exemplary Embodiments of the Invention

[0035] The invention will be further clarified using exemplary embodiments with reference to the respective drawings.

[0036] Example 1 :

[0037] In the first exemplary embodiment, shown in fig. 1 to fig. 5, a cranial remodeling orthosis comprises a front portion 1. and a rear portion 2, wherein the front portion 1_ is adapted in shape to the shape of the front portion of the the wearer's head and the rear portion 2 is adapted in shape to the shape of the rear portion of the the wearer's head. Thus, the front portion 1. and the rear portion 2 form the two basic parts of the cranial remodeling orthosis, and by combining them the entire cranial remodeling orthosis is assembled.

[0038] As best seen in fig. 1 , the partition between the front portion 1. and the rear portion 2 is vertical. It is then apparent from the exploded view of fig. 2 or fig. 4 that the front portion 1_ and the rear portion 2 comprise contact surfaces provided with a shape guide 5 for precisely align the relative position of the front portion 1_ and the rear portion 2. This ensures that the front portion 1_ and the rear portion 2 are precisely flush with each other when connected. In the exemplary embodiment described, the shape guide 5 comprises mutually shape-complementary elements arranged on the front portion 1. and the rear portion 2. Specifically, the front portion 1. is provided with shape cavities and the rear portion 2 is provided with shape protrusions that fit into the shape cavities with their shapes.

[0039] For example, the front portion 1_ and the rear portion 2 are implemented as rigid shells made by 3D printing technology tailored to the patient such that the assembled cranial remodeling orthosis allows treatment of head deformations as needed. In order for the front portion 1. and the rear portion 2 to hold together and form a functional cranial remodeling orthosis, they are connected to each other on both lateral sides of the cranial remodeling orthosis. As can be clearly seen in the section A-A of fig. 5, there is a clamping mechanism 3 on one lateral side of the cranial remodeling orthosis, and there is a hinge mechanism 4 on the opposite lateral side of the cranial remodeling orthosis. Both the clamping mechanism 3 and the hinge mechanism 4, which mainly improves the solutions known from the state of the art, will be described in more detail below.

[0040] The clamping mechanism 3 provides removable connection between the front portion 1. and the rear portion 2 on one lateral side of the cranial remodeling orthosis. Thus, when the clamping mechanism 3 is unfastened, the front portion 1. and the rear portion 2 on this lateral side are separated and subsequently opened, as the front portion 1. and the rear portion 2 remain connected on the opposite lateral side by the hinge mechanism 4.

[0041] In the exemplary embodiment described, the clamping mechanism 3 comprises two parts, which are located individually on the front portion 1. and the rear portion 2. For example, the first part of the clamping mechanism 3 is arranged on the front portion 1_ and comprises a lever 3a, which is rotatably connected at one of its ends to the shell of the front portion 1_. A loop 3b is attached to this lever 3a. The second part of the clamping mechanism 3 is arranged on the rear portion 2 and comprises at least one slot 3c for the loop 3b. To firmly connect the front portion 1. and the rear portion 2 by means of the clamping mechanism 3, the loop 3b is inserted from the outer side into the slot 3c for the loop 3b and subsequently the lever 3a is rotated toward the shell of the front portion 1_. In this position, the lever 3a is located along the shell of the front portion 1. and copies its curved shape as shown in fig. 5. The unfastening of the clamping mechanism 3, and hence the separation of the front portion 1. and the rear portion 2 on said lateral side of the cranial remodeling orthosis, is conversely achieved by rotating the lever 3a away from the shell of the front portion 1_, to a position approximately perpendicular to the outer wall of the shell of the front portion 1_, and subsequently removing the loop 3b from the slot 3c for the loop 3b.

[0042] As mentioned above, the hinge mechanism 4 is located on the opposite lateral side of the cranial remodeling orthosis and forms the hinged connection of the front portion 1_ and the rear portion 2. The hinge mechanism 4 thus allows the front portion 1. and the rear portion 2 to open (swung away) from each other when the clamping mechanism 3 is unfastened.

[0043] The hinge mechanism 4 comprises primarily a hinge 4a of a flexible material that is removably housed in the front portion 1_ and the rear portion 2. For the removable housing of the hinge 4a, the hinge mechanism 4 further comprises at least one recess 4c for the hinge 4a formed in the front portion 1. and at least one recess 4c for the hinge 4a formed in the rear portion 2. These recesses 4c for the hinge 4a are adapted in shape for housing the hinge 4a, wherein the hinge 4a in the recesses 4c for the hinge 4a is held by its shape and by friction. However, by exerting a certain force, the friction may be overcome and the hinge 4a may be removed from the recess 4c for the hinge 4a. Specifically, the recesses 4c for the hinge 4a are formed in the contact surfaces of the front portion 1. and the rear portion 2, by which the front portion 1. and the rear portion 2 abut each other when connected. The recess 4c for the hinge 4a is best visible in fig. 4 and fig. 5.

[0044] In fig. 2 in exploded view and in fig. 5 in the section view, it can be clearly seen that the hinge 4a has an elongated shape. Thus, the first end, with which the hinge 4a is removably housed in the front portion 1_, and the second end, with which the hinge 4a is removably housed in the rear portion 2, can be defined. It can also be said that the hinge 4a has a substantially flat shape, wherein this flat shape of the hinge 4a is interrupted by a stop 4b, which is located, for example, in the central part of the hinge 4a. In the first exemplary embodiment, the stop 4b is an integral part of the hinge 4a and extends integrally perpendicularly from its outer side, i.e. , the side that is oriented away from the cranial remodeling orthosis. The stop 4b first extends from the hinge 4a in the form of a thin partition, which at the farthest end widens into a flat shape which, when viewed from the outer side, is approximately rectangular, or rectangular with rounded corners. To ensure that the stop 4b does not hinder the precise alignment of the relative position of the front portion 1. and the rear portion 2, recesses 4d for the stop 4b are individually created in the front portion 1. and in the rear portion 2. These recesses 4d for the stop 4b correspond in shape to the widened end of the stop 4b, or, as can be clearly seen e.g. in fig. 2, each recess 4d for the stop 4b corresponds to the corresponding half of the widened end of the stop 4b. Thus, each recess 4d for the stop 4b has an essentially rectangular shape with two corners rounded. The individual recesses 4d for the stop 4b are specifically formed in the contact surfaces of the front portion 1 and the rear portion 2, similar to the individual recesses 4c for the hinge 4a, and are accessible from the same sides for housing the stop 4b as the recesses 4c for the hinge 4a are accessible for housing the hinge 4a.

[0045] It can be seen from fig. 1 or fig. 3, which shows the cranial remodeling orthosis in the assembled state, that when viewed from the outside, only this stop 4b is visible, which fits precisely into the space formed by the two recesses 4d for the stop 4b, when the front portion 1. and the rear portion 2 are tilted together. In addition, the stop 4b has such a shape and dimensions that its outer surface is aligned with the outer surface of both shells. Therefore, the stop 4b does not protrude outward from the cranial remodeling orthosis in any way. The hinge 4a itself is not visible at all in the assembled state of the cranial remodeling orthosis, as it is entirely hidden in the space formed by the two recesses 4c for the hinge 4a. As can be seen in fig. 5, only the vertical partition between the front portion 1. and the rear portion 2 is visible from the inner side of the cranial remodeling orthosis.

[0046] When opening the front portion 1_ and the rear portion 2 (if the clamping mechanism 3 is unfastened), the stop 4b acts as a protective element preventing the edges of the front portion 1. and the rear portion 2 from rubbing against each other. This is made possible by the fact that at the location of the stop 4b, the material of the stop 4b is located between the edges of the front portion 1_ and the rear portion 2, and these edges do not come into direct contact in the place of the stop 4b when mutually opened.

[0047] The flexible material from which the hinge 4a and the stop 4b are made is, for example, an elastomer (TPU, TPA, silicone rubber, etc.) or thermoplastic (PE, PP, CPP, ABS) and is made, for example, by 3D printing as the shells of the front portion 1. and the rear portion 2 described above. However, the hinge 4a has a lower stiffness (i.e. higher elasticity) than the material of the shells. The elasticity of the hinge 4a not only allows the front portion 1_ and the rear portion 2 to open but also the shape of the hinge 4a is adapted to the curved shape of the cranial remodeling orthosis. This is best seen in fig. 5, where it is apparent that housing the hinge 4a in the recess 4c for the hinge 4d results in bending the hinge 4a.

[0048] In the first exemplary embodiment described, the hinge mechanism 4 also comprises a locking element 4e and, further, a slot 4f for the locking element 4e, which is arranged in the front portion 1. and in the rear portion 2. The locking element 4e helps to hold the front portion 1. and the rear portion 2 together on this lateral side of the cranial remodeling orthosis. As best seen from exploded view in fig. 2 or fig. 4, in this exemplary embodiment, the locking element 4e is an elastic circumferential ring, so-called O-ring, which is inserted into both slots 4f for the locking element 4e. In this embodiment, the locking element 4e of the hinge mechanism 4 is implemented in the same way as the loop 3b of the clamping mechanism 3, i.e. , for example, the loop 3b is also implemented as an elastic circumferential ring.

[0049] For example, the individual slots 4f for the locking element 4e have a shape resembling a horizontal letter U, wherein the open ends of the individual slots 4f for the locking element 4e are accessible from the same sides as in the case of the recess 4c for the hinge 4a and the recess 4d for the stop 4b. In addition, the slots 4f for the locking element 4e are also open from the outer side of the cranial remodeling orthosis. As can be seen e.g. in fig. 4, the individual slots 4f for the locking element 4e define, by their shape, parts of the front portion 1. or the rear portion 2, in which the recesses 4c for the hinge 4a and the recesses 4d for the stop 4b are formed.

[0050] In the assembled state of the cranial remodeling orthosis of fig. 1 or fig. 3, the individual slots 4f for the locking element 4e are connected by their open ends. This creates one common closed slot 4f for the locking element 4e.

[0051] Example 2:

[0052] In the second exemplary embodiment, which is shown in fig. 6 to fig. 9, the cranial remodeling orthosis is implemented the same way as in the first exemplary embodiment except for the fact that the hinge 4a with the stop 4b are implemented differently. In contrast to the first exemplary embodiment and with respect to the different implementation of the hinge 4a, the recesses 4c for the hinge 4a are also modified, as described below. Particularly in fig. 8 and fig. 9, which show a detailed view of the hinge 4a with the stop 4b, it can be clearly seen that the stop 4b is not an integral part of the hinge 4a in this embodiment but is slid onto the hinge 4a. Otherwise, however, as in the first exemplary embodiment, the approximately rectangular part of the stop 4b is located on the outer side of the hinge 4a. This can be seen in fig. 6.

[0053] For sliding onto the hinge 4a, the stop 4b comprises an eye, which is adapted in shape such that the hinge 4a can be pulled through it during assembly but simultaneously such that the stop 4b does not fall out of the hinge 4a. With respect to the flat shape of the hinge 4a, the eye has an elongated shape. In addition, the hinge 4a is prevented from slipping out of the eye of the stop 4b by the shape projections 4g, which are located at both ends of the hinge 4a. Since the stop 4b is made of a flexible material (for example TPU, e.g,. using a 3D printing method), it may be pulled over these shape projections 4g during fitting and remains in the central part of the hinge 4a due to its elasticity. For example, the hinge 4a is made from Vulkollan, i.e., a high-elasticity polyurethane elastomer, for example from a flat polyurethane plate by laser or waterjet cutting.

[0054] However, the shape projections 4g primarily ensure reliable housing of the hinge 4a in the recess 4c for the hinge 4a. In addition to the shape projections 4g, the reliability of this housing may also be improved by means of shape recesses 4h, which may be seen e.g. in fig. 7 as notches running in the longitudinal direction of the hinge 4a from its individual ends. It can also be seen in this figure that in this particular embodiment, the shape projections 4g taper towards the ends of the hinge 4a. With respect to the particular shape of the hinge 4a, the shape of the recess 4c for the hinge 4a is also modified, wherein the shape of the recess 4c for the hinge 4a copies the shape of the hinge 4a. This creates mechanical connection that firmly holds the hinge 4a in the recess 4c for the hinge 4a, but when exerting a certain force (to overcome friction and also the engagement of the shape projections 4g and the shape recesses 4h with the corresponding parts of the recess 4c for the hinge 4a), the hinge 4a may be removed from the recess 4c for the hinge 4a.

[0055] Example 3:

[0056] In the third exemplary embodiment, which is shown in fig. 10 to fig. 13, the cranial remodeling orthosis is implemented in the same way as in the second exemplary embodiment except for the fact that the stop 4b is implemented differently. In this embodiment, the stop 4b also comprises an eye for sliding onto the hinge 4a, but in addition to this eye it further comprises a suspension in the form of a loop. As can be seen from fig. 11 or fig. 13, the suspension is oriented approximately perpendicular to the eye and thus substantially parallel to the hinge 4a. Using the suspension, the stop 4b, or rather the stop 4b slid onto the hinge 4a, is suspended to the shell of the cranial remodeling orthosis. Here in particular, the stop 4b is suspended from the front portion 1_ in a place that is defined by the slot 4f for the locking element 4e. Thus, when assembling the cranial remodeling orthosis, the suspension is first inserted into the slot 4f for the locking element 4e and subsequently, the locking element 4e is also inserted into the slot 4f for the locking element 4e. For these purposes, the suspension is made of an elastic material, as is the hinge. For example, the stop 4b (the eye and the suspension) is made of TPU, e.g., by 3D printing method, and the hinge 4a is made, for example, of Vulkollan.

[0057] Further exemplary embodiments may be created, e.g., by combining features of the individual embodiments described above. In one alternative exemplary embodiment, e.g., the hinge 4a with an integrated stop 4b as was described in Example 1 is used, but this hinge 4a has shape projections 4q or shape recesses 4h as was described in Example 2 or Example 3.

[0058] Industrial Applicability

[0059] The above described cranial remodeling orthosis with a hinge mechanism can be used for the treatment of head deformations, especially in newborns, infants and toddlers. List of Reference Signs

[0060] 1 - front portion

[0061] 2 - rear portion

[0062] 3 - clamping mechanism

[0063] 3a - lever

[0064] 3b - loop

[0065] 3c - slot for the loop

[0066] 4 - hinge mechanism

[0067] 4a - hinge

[0068] 4b - stop

[0069] 4c - recess for the hinge

[0070] 4d - recess for the stop

[0071] 4e - locking element

[0072] 4f - slot for the locking element

[0073] 4g - shape projection

[0074] 4h - shape recess

[0075] 5 - shape guide

Claims

CLAIMS1. A cranial remodeling orthosis with a hinge mechanism (4) comprising a front portion (1 ), a rear portion (2), at least one clamping mechanism (3) for removable connection of the front portion (1 ) and the rear portion (2) on one lateral side of the cranial remodeling orthosis, and, further, a hinge mechanism (4) for hinged connection of the front portion (1 ) and rear portion (2) on the opposite lateral side of the cranial remodeling orthosis characterized in that the hinge mechanism (4) comprises a hinge (4a) from a flexible material housed in the front portion (1 ) and the rear portion (2).

2. The cranial remodeling orthosis according to claim 1 , characterized in that the hinge (4a) is housed in the front portion (1 ) and the rear portion (2) removably.

3. The cranial remodeling orthosis according to any one of the preceding claims, characterized in that the hinge (4a), when housed in the front portion (1 ) and the rear portion (2), is completely embedded in the front portion (1 ) and the rear portion (2).

4. The cranial remodeling orthosis according to any one of the preceding claims, characterized in that the front portion (1 ) and the rear portion (2) are provided with a shape guide (5) for precisely aligning the relative position of the front portion (1 ) and the rear portion (2).

5. The cranial remodeling orthosis according to any one of the preceding claims, characterized in that the hinge (4a) is provided with a stop (4b), wherein when the hinge (4a) is housed in the front portion (1 ) and the rear portion (2), at least a part of the stop (4b) is located between the edges of the front portion (1 ) and the rear portion (2).

6. The cranial remodeling orthosis according to claim 5, characterized in that at least one of the front portion (1 ) and the rear portion (2) comprises a recess (4d) for the stop (4b), wherein when the hinge (4a) is housed in the front portion (1 ) and the rear portion (2), at least a part of the stop (4b) is located in the recess (4d) for the stop (4b).

7. The cranial remodeling orthosis according to any one of claims 5 and 6, characterized in that the stop (4b) is an integral part of the hinge (4a).

8. The cranial remodeling orthosis according to any one of claims 5 and 6, characterized in that the stop (4b) is slid onto the hinge (4a).

9. The cranial remodeling orthosis according to any one of the preceding claims 5 to8, characterized in that the stop (4b) comprises a suspension for suspending from the front portion (1 ) and / or the rear portion (2).

10. The cranial remodeling orthosis according to any one of the preceding claims, characterized in that the hinge mechanism (4) further comprises a locking element (4e) for holding the front portion (1 ) and the rear portion (2) together.

11. The cranial remodeling orthosis according to claim 10, characterized in that the locking element (4e) is a loop, wherein at least one of the front portion (1 ) and the rear portion (2) comprises a slot (4f) for the locking element (4e).

12. The cranial remodeling orthosis according to any one of the preceding claims, characterized in that the hinge (4a) comprises at least one shape projection (4g) and / or at least one shape recess (4h).

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