Skull remodeling orthosis

Abstract

The invention aims to provide a skull remodeling orthosis and a design and production method thereof. The skull remodeling orthosis of the present invention comprises an outer housing (1) and an inner housing (4) wherein an inner wall (2) of the outer housing defines an inner cavity (3) of the outer housing for insertion of the head of a wearer wherein the skull remodeling orthosis further comprises an inner housing (4) removably connected to the outer housing (1), wherein the inner housing (4) defines a reduced interior cavity (5) for insertion of the wearer's head, the reduced interior cavity having a smaller volume than the interior cavity (3) of the outer housing. The inner housing (4) is removably connected to the outer housing (1) at at least two different locations distributed around the circumference of the inner housing (4).

Description

TECHNICAL FIELD

[0001] The present invention relates to a cranial remodeling orthosis, in particular for treating head deformities in newborns, infants and toddlers. BACKGROUND

[0002] Cranial remodeling orthoses are used to fix or support the remodeling of the head of the wearer into an appropriate shape. These orthoses must be precisely adapted to the head of the specific wearer in order to achieve their comfort and proper functioning of the cranial orthosis.

[0003] For example, newborns, infants and toddlers sometimes experience unwanted head deformities, usually caused by lying in the same position often, which require prompt corrective treatment to correct the shape of the head. These deformities include so-called plagiocephaly, a defect in the symmetry of the head, brachycephaly, a defect in the proportions of the head, or a combination of both, known as asymmetrical brachycephaly, in which the head exhibits both asymmetry and defective proportions. Plagiocephaly is manifested, for example, by asymmetric flattening on the back of the head, a forehead bulge on the side of the back flattening, ear displacement forward on the side of the back flattening, or asymmetry in the position of the face. Brachycephaly is manifested by symmetric flattening on the back of the head when viewed from above, a widening of the head, or a higher skull. The combination of these two types of deformity is subsequently manifested by bilateral flattening of the back of the head, in which one side of the head is flatter than the other, a greater flattening of the forehead forward on the side of the greater occipital flattening, or ear displacement forward on the side of the greater occipital flattening.

[0004] These defects can be treated by wearing a cranial orthosis. Such an orthosis has an internal cavity for receiving the head, which is specifically designed to correspond to the head shape that the head should have at the end of treatment. Such an orthosis subsequently guides the correction of the head shape during growth. This means that in certain positions the internal walls of the shell of the cranial orthosis do not come into contact with the head, so that in these positions the head growth is supported; while in the positions where the internal walls of the shell of the cranial orthosis come into contact with the head, the head growth is limited. However, ensuring this ideal shape of the internal walls of the shell that ensures proper growth results in a cranial orthosis that, due to its functional nature, cannot firmly fit on the head of the wearer, in which unwanted rotation of the orthosis with respect to the head often occurs, which results in a decrease in the comfort of the wearer and a decrease in the effectiveness of the cranial orthosis treatment.

[0005] Currently, several solutions exist to ensure a better fit of cranioplasty devices to the wearer's head. The issue of a better fit is often addressed by shaping the inner wall of the shell not to conform to the target head shape, but rather to correspond only to specific intermediate growth stages toward that target shape. In this solution, the shape of the shell's inner cavity is adjusted so that the gap between the head and the shell's inner wall decreases at the deformed position, preventing such large, unwanted rotational movements while simultaneously supporting growth at a given position—that is, the head still does not contact the shell's inner wall at the deformed position. The main drawback of this solution is the need for frequent replacement of cranioplasty devices, as a new device must be fabricated after the head has grown to the inner wall of the shell at the deformed position to again provide growth space at that location. Therefore, a large number of cranioplasty devices must be used during treatment, each corresponding to a different intermediate stage of head growth toward the target physiological shape. Consequently, treatment requires a large amount of material to produce different shells, more expert time to plan the entire treatment, and frequent patient checkups, making the treatment significantly more complex and expensive.

[0006] In solutions where the shell is made of a material that can be ground from the inside, these costs are reduced, where specialists grind the inside of the cranioplasty during treatment, allowing the internal shape to support growth in deformed areas. Based on continuous examination, the inside of the orthosis is gradually ground into the ideal shape the head should have. This process is technically demanding and requires a high level of expertise; it is not possible to simply monitor and predict the treatment process, which must always respond to the actual shape of the wearer's head during examination. Furthermore, in the early stages of wear, the cranioplasty can become excessively heavy due to the need to contain all the gradually worn material, which may lead to developmental complications in the neck and spine, potentially resulting in neck and spinal injuries.

[0007] Another solution to the aforementioned problem is, for example, a cranial orthosis with adjustable fasteners, as described in document WO2019115965 A1. The helmet can be gradually opened as the head grows into the current volume within the shell via adjustable fasteners on the side. No modifications to the helmet are required, nor is it necessary to continuously manufacture new helmets. However, this solution is only applicable to certain types of deformities, and its effectiveness is significantly limited. Furthermore, it is a structurally demanding solution and carries the risk of undesirable displacement of the clamping mechanism.

[0008] Another related prior art is document CN 217448164, which discloses the principle of replacing the inner shell during treatment.

[0009] For the reasons mentioned above, it is desirable to develop a cranioplasty orthosis that is securely and comfortably placed on the wearer's head and provides appropriate treatment for a variety of different head deformities throughout the entire period of wearing the cranioplasty orthosis. Summary of the Invention

[0010] The cranioplasty of the present invention eliminates the above-mentioned disadvantages. The cranioplasty includes an outer shell, wherein the inner wall of the outer shell defines an inner cavity of the outer shell for insertion of a wearer's head, and wherein the cranioplasty further includes an inner shell removably connected to the outer shell, wherein the inner shell defines a reduced inner cavity for insertion of a wearer's head, the reduced inner cavity having a smaller volume than the inner cavity of the outer shell.

[0011] The advantage of the cranioplasty orthosis of the present invention is that it is placed securely and comfortably on the wearer's head, while providing appropriate treatment for a variety of different head deformities throughout the entire period of wearing the cranioplasty orthosis.

[0012] Therefore, the shell of the cranioplasty of the present invention comprises at least two components: an outer shell and an inner shell. The outer shell refers to the basic load-bearing component of the cranioplasty, defining the external shape of the orthosis and ensuring sufficient robustness and structural stability. The outer shell includes an inner wall that defines the inner cavity of the outer shell and forms the basis for defining an inner cavity of the cranioplasty suitable for accommodating the wearer's head. The inner cavity of the outer shell is not intended to refer to a cavity within the outer shell wall, but rather a cavity defined by the shape of the outer shell and to a certain extent defining the space for accommodating the wearer's head, wherein the resulting space of the cranioplasty for accommodating the wearer's head is represented by the inner cavity of the cranioplasty. In various embodiments, the inner wall of the outer shell may be provided with a lining or additional layer to ensure, for example, greater comfort or safety. The outer shell may be implemented as a thin-walled shell comprising only one shell or layer, or may include an inner shell and an outer shell with a mesh 3D structure between them to enhance the structure, or a combination of these variations. In some embodiments, the inner wall of the outer shell may represent the inner wall of the cranioplasty, in other words, it may directly define the cavity of the cranioplasty adapted to receive the wearer's head. In other embodiments, the cranioplasty may include additional components placed within the outer shell that form the entire inner wall of the cranioplasty, thus forming the cavity of the cranioplasty adapted to receive the wearer's head, or these additional components may only partially form the cavity together with the inner wall of the outer shell. Therefore, in some embodiments, the cavity of the outer shell may not correspond to the cavity of the cranioplasty, or in some embodiments, the inner wall of the outer shell may not correspond to the inner wall of the cranioplasty.

[0013] The cavity of a cranioplasty for the wearer's head to be inserted refers to the space within the cranioplasty that the cranioplasty is shaped around and that space is adapted to accommodate the wearer's head, thus roughly corresponding to the external shape of the wearer's head. The cavity of the cranioplasty is defined by a shell or other layers placed on the inner wall of the shell, wherein its openings correspond to the edge contour of the shell, which, in cranioplasty remodeling orthoses, extends above the eyebrows, then around the ears on both sides of the head, and converges in the occipital region. The internal shape of the cavity of the cranioplasty remodeling orthose, or more precisely, the orthose, roughly corresponds to the shape of the skull in the frontal, parietal, and occipital regions. Viewed from the inside, the inner shell and / or outer shell may include linings or additional layers placed on the inner wall of the shell to improve the comfort or breathability of the cranioplasty. These additional layers naturally affect the shape of the inner wall of the cranial orthosis, and thus the shape of the cavity of the cranial orthosis used to accommodate the head, in which these additional layers must be taken into account in the design of the inner and outer shells.

[0014] The inner housing can be removably attached to the outer housing in various ways. For example, the inner housing can be directly attached to the inner wall of the outer housing, such that the inner and outer housings form a continuous member. In this embodiment, the inner housing is attached to the outer housing by bridging members at at least two locations around its circumference, preferably at least four locations around its circumference, and more preferably around its entire circumference. These pins / bridging members are thin and fragile compared to the rest of the housing structure, and thus break when the inner housing is twisted relative to the outer housing, allowing the inner housing to be removed from the cavity of the outer housing. In other embodiments, the inner housing may extend above the edge of the outer housing, wherein in these embodiments, the inner housing may also be attached to the outer side of the outer housing. Additionally, the inner housing can be attached to the outer housing by adhesive, double-sided adhesive tape, or by mechanical connection (such as a groove-protrusion type), or via resilient stops. In some embodiments, the inner housing may be attached to the outer housing via a liner. In other embodiments, the inner housing may be attached to the inner wall of the outer housing. Therefore, a removable connection between the inner and outer shells usually means this specific implementation of their connection that allows the inner and outer shells to be separated without causing significant damage to the outer shell that would limit the function of the craniotomy.

[0015] Furthermore, the outer shell may consist of multiple parts connected by a clamping mechanism when placed on the wearer's head. In these embodiments, the descriptions of the inner wall of the craniotomy, the inner wall of the outer shell, the inner cavity of the outer shell, and the inner cavity of the craniotomy refer to the shell in the assembled position, where all components of the outer shell are placed together.

[0016] In the context of this invention, the cranioplasty has a variable cranioplasty cavity, wherein the size of the cranioplasty cavity can be changed when the inner shell is removed from the outer shell, or by replacing one inner shell with another. In this context, two cavities are defined in the cranioplasty: a target cavity and a reduced cavity. The reduced cavity of the cranioplasty is defined by a reduced inner wall of the cranioplasty, and the target cavity of the cranioplasty is defined by a target inner wall of the cranioplasty, wherein the reduced cavity of the cranioplasty has a smaller volume than the target cavity of the cranioplasty, or the target cavity is adapted to accommodate a wearer's head with a larger volume. Thus, generally, the target cavity and the reduced cavity of the cranioplasty correspond to different stages of head growth during remodeling, wherein the reduced cavity corresponds to an intermediate stage of head growth to the target shape of the wearer's head, which corresponds to the target cavity of the cranioplasty. The reduced wall of the cranioplasty may be formed by the inner and outer shells together or entirely by the inner shell. The target wall of the cranioplasty may be formed by the inner and outer shells together, entirely by the inner shell, or entirely by the outer shell. Additional layers (such as, for example, linings on the inner or outer shell) affect the shape of the reduced inner wall or cavity or the target inner wall or cavity, wherein the specific implementation of the inner and / or outer shells must be adapted in shape to the given additional layers such that they together form the desired shape of the inner wall of the cranioplasty, and thus the desired shape of the cavity of the cranioplasty.

[0017] The reduced cavity of the cranioid corresponds to the volume of the target cavity of the cranioid minus the volume occupied by the inner shell from the target cavity volume. Therefore, the reduced cavity means that the target cavity of the cranioid has been reduced in volume by a certain amount, which is defined by the inner shell inserted into the cavity of the outer shell.

[0018] Preferably, the inner shell is removably connected to the inner wall of the outer shell. In these embodiments of the invention, the inner wall of the outer shell has a generally concave or convex shape adapted to the shape of the head and defining an inner cavity of the outer shell that also corresponds to the target inner cavity of the craniotomy. The inner shell preferably has a shape that generally follows the concavity of the inner wall of the outer shell at a given location. As the difference between the target inner cavity and the reduced inner cavity increases, or as the volume of the inner cavity of the outer shell surrounded by the inner shell increases, the shape of the inner shell becomes flatter relative to the shape of the area of ​​the inner wall of the outer shell covered by the inner shell. The inner shell preferably follows the wall of the inner cavity of the outer shell continuously, wherein the transition between the inner wall of the outer shell and the surface of the inner shell is gradual and smooth to maximize wearer comfort. In these embodiments, the reduced inner wall of the craniotomy is formed by the surface of the inner shell or by the inner wall of the inner shell and the inner wall of the outer shell together, wherein, after the inner shell is removed, the target inner wall of the craniotomy is formed by the inner wall of the outer shell.

[0019] In other alternative preferred embodiments, the cranioplasty of the present invention is part of an assembly that further includes at least one other inner housing for removable connection to an outer housing, wherein each of the at least two inner housings defines a different reduced inner cavity with a different volume. In these embodiments, the assembly includes two interchangeable inner housings: a first inner housing and a second inner housing, both adapted for removable connection to an outer housing. The first inner housing may at least partially form a reduced inner wall of the cranioplasty, wherein, upon replacement, the second inner housing at least partially forms a target inner wall of the cranioplasty. In this embodiment of the invention, the cavity of the outer housing does not represent the cavity of the cranioplasty because it is not adapted to accommodate the wearer's head. In other embodiments, the first inner housing may form a first reduced inner wall of the cranioplasty, the second inner housing may form a larger second reduced inner wall of the cranioplasty, and the target inner wall of the cranioplasty may be formed by the inner wall of the cranioplasty. The components of the cranioplasty orthotine of this embodiment of the invention include an outer shell and at least two inner shells, wherein the inner shells are adapted to define different cavities of the cranioplasty orthotine corresponding to different growth stages of the wearer's head when connected to the outer shell.

[0020] Preferably, the inner housing includes a perforated surface. The surface of the inner housing can be rigid or flexible, wherein increased flexibility can be achieved through perforation or material selection. Preferably, the inner housing further includes a mesh 3D structure that at least partially fills the volume between the surface of the insert and the inner wall of the craniotomy. The inner housing includes a surface, wherein the surface of the inner housing can be continuous or perforated. The inner housing can be implemented simply as a wall defining a specific shape of the surface of the insert, the wall being adapted to be removably connected to the outer housing at its circumference. In other embodiments, the inner housing may include a 3D mesh structure that at least partially fills the space between the surface of the inner housing and the inner wall of the craniotomy covered by the inner housing, wherein the 3D mesh structure may also form the surface of the inner housing.

[0021] Mesh 3D structures include shaped openings distributed throughout their volume, the specific implementation of which can be used to modify the flexibility or stiffness of an internal shell or only a portion thereof. Depending on their specific shape, spacing, and size, the openings modify the stiffness of a given area and cause it to extend in different directions. An opening refers to a volumetric cutout of a specific shape within the volume of a mesh 3D structure. The stiffness of a mesh 3D structure is determined by the specific shape, spacing, and size of the openings located within a given volume. The distribution of openings within the volume of a mesh 3D structure results in a rigid structure filling the volume between them having the structure of a three-dimensional (3D) mesh. In cases where the openings are small, have shapes that provide greater stiffness to the surrounding structure, and / or are spaced apart, a thicker structure of material filling the spaces between the openings is implemented, thereby ensuring higher stiffness of the mesh 3D structure. A thicker 3D-printed structure refers to a structure with a larger cross-section at the locations between the openings and a higher volumetric representation proportional to the volumetric representation of the openings. If the openings have a large shape that provides lower stiffness to the surrounding structure and / or the openings are positioned close together, a weaker structure of material is achieved to fill the space between the openings, thus ensuring lower stiffness of the mesh 3D structure. A weaker 3D printed structure means a structure with a smaller cross-section at the location between the openings and a smaller volume representation relative to the volume representation of the openings.

[0022] In various embodiments of the inner and outer shells, the cranioplasty of the present invention forms a target inner wall defining a target cavity of the cranioplasty and a reduced inner wall defining a reduced cavity of the cranioplasty. In the context of the present invention, the target cavity and the reduced cavity of the cranioplasty can also be understood as cavities defined not only by the cranioplasty but also by the external shape of the wearer's head, particularly the initial shape of the wearer's head. In other words, generally speaking, the inner cavity of the cranioplasty can be understood as the cavity between the external shape of the wearer's head and the inner wall of the cranioplasty. Therefore, the target inner cavity of the cranioplasty can be understood as the cavity between the initial external shape of the wearer's head and the target inner wall of the cranioplasty, and the reduced inner cavity of the cranioplasty can be understood as the cavity between the initial external shape of the wearer's head and the reduced inner wall of the cranioplasty. In this sense, the reduced inner cavity of the cranioplasty can be 10% to 90% smaller than the target inner cavity of the cranioplasty, preferably 40% to 60% smaller.

[0023] The inner shell of the present invention is preferably adapted to be placed within the cavity of the outer shell of the craniotomy, in a region corresponding to a significant deformity on the wearer's head—that is, a region where the current shape of the wearer's head is significantly smaller than the normal physiological shape of the head, which is the target of treatment using the craniotomy, where growth will be supported by the orthosis in this location, whereas in other regions of the head, growth may be restricted by the orthosis. Therefore, the inner wall of the inner shell corresponds to the shape of the head at a specific intermediate stage between the current shape of the head and the target physiological shape of the head.

[0024] For the invention to function properly, when centered, the reduced inner walls must at least partially correspond to the target inner wall of the craniotomy. Their shape difference is only required at the deformed position, where the reduced inner walls at least partially reduce the space between the wearer's head and the target inner wall of the craniotomy. The inner shell must form the reduced inner walls such that it corresponds to an intermediate stage of head growth at the deformed position, while in other areas of the head, growth support is not desired because they have a shape already corresponding to the target external shape of the head, where the inner wall of the craniotomy remains unchanged in both the reduced and target versions (where it is not part of the deformity).

[0025] Preferably, the inner shell is connected to the outer shell at at least two different locations distributed around its circumference. Preferably, the inner shell is connected to the inner wall of the cranioplasty along a large portion of its circumference. In embodiments where the inner shell is connected to the inner wall of the outer shell, preferably, the inner shell has a rounded edge, and preferably, the connection to the outer shell is located around the circumference of the inner shell to ensure the most stable possible adhesion between the inner and inner sides of the outer shell, thereby preventing gaps from forming between the shells at the circumference. Similarly, in embodiments where the inner shell is connected to the outer shell in other areas of the outer shell (such as around its circumference at openings in the inner cavity of the outer shell or from the outer side of the outer shell), it is also preferred here that the connection is located around the circumference or edge of the inner shell. Therefore, the connections are not located where the inner shell and / or the outer shell form the inner wall of the cranioplasty, where they do not structurally affect the structure of the shells at these locations, and the structure of the inner wall of the cranioplasty can be fully focused on the function and comfort of the cranioplasty.

[0026] Preferably, the inner shell is made of 3D printed material. Both the inner and outer shells are preferably made using 3D printing technologies (such as SLA, SLS, FDM, MJF, DLP, 3DP, PJF, CLIP). Materials used to produce the inner and / or outer shells can be, for example, polymers such as PA, ABS, PLA, PE, PP, CPP, HPP, PC, PETG, photopolymers, elastomers (TPU, TPA, TPE, silicone), and other materials not only applicable to the aforementioned 3D printing methods. Preferably, thermoplastic elastomers, such as thermoplastic polyamide (TPA), thermoplastic polyurethane (TPU), or copolymer blends (TPE), are used to produce the 3D mesh structure.

[0027] The method for designing and manufacturing the cranial remodeling orthosis of the present invention includes the following steps:

[0028] a) Obtain a model of the external shape of the wearer's head.

[0029] b) Designing a cranioplasty model based on a model of the wearer's head external shape, including the step of determining the target external shape of the wearer's head based on the model of the wearer's head external shape, and subsequent steps of determining the target inner wall of the cranioplasty that defines the target cavity of the cranioplasty.

[0030] c) Production of cranial orthotics

[0031] The step (b) of designing the model of the cranial orthosis further includes the step of determining the reduced inner wall of the cranial orthosis that defines the reduced inner cavity of the cranial orthosis, the step of which includes comparing a model of the external shape of the wearer's head with a representation of the target external shape of the wearer's head, the step (b) of designing the model of the cranial orthosis further includes the step of designing an inner shell based on the step of determining the reduced inner wall of the cranial orthosis, wherein the reduced inner wall of the cranial orthosis is at least partially formed by the inner shell, and the step (c) of manufacturing the cranial orthosis includes the step of manufacturing the inner shell.

[0032] The initial step in designing and manufacturing the cranioplasty orthopedic device of the present invention is to obtain a model of the external shape of the wearer's head or a 3D model based on the actual anatomical shape of the wearer's head, wherein this model can be obtained in several ways, ranging from various scanning methods to inputting measurement data into a computer device for designing a 3D model of the head based on the data. The wearer refers to the person to whom the cranioplasty orthopedic device is intended. The most common method for obtaining a 3D model based on the anatomical shape of the wearer's head is to perform a direct 3D scan of the wearer's head. During the 3D scan, the data obtained from the 3D scan of the wearer's head is converted into a polygonal mesh of defined points with a density of at least 10 points / cm². 2 Another method is, for example, to create a physical model of the wearer's head based on a mold of the wearer's head, and then to 3D scan the created physical model. In some cases, it is recommended to modify the physical model of the head before 3D scanning. Other methods for obtaining a model of the external shape of the wearer's head include, for example, digitizing the internal regions of an existing craniotomy, or creating a physical model of the wearer's head from an existing craniotomy, and then digitizing the external regions of the obtained physical model of the head, which may be modified before digitization. Alternatively, a model of the external shape of the wearer's head can be obtained by first measuring the wearer's head (e.g., its circumference, width, length, and diagonal dimensions), and these data are input into a computer device based on user input, which designs a 3D model based on these data. The resulting 3D model based on the anatomical shape of the wearer's head is then uploaded from a scanning device to a computer device, where it is further processed within the design method according to the invention.

[0033] The next step is to design a cranioplasty model, which includes determining the target external shape of the wearer's head, determining the target inner wall of the cranioplasty, determining the reduced inner wall of the cranioplasty, and designing the inner shell. The step of determining the target external shape of the wearer's head is performed based on input parameters from a model that includes the external shape of the wearer's head. The model of the external shape of the wearer's head can be modified to better suit the wearer's specific needs before proceeding to further steps. Therefore, the model of the external shape of the wearer's head can refer to a physical representation, a modified physical representation, a digital representation, or a modified digital representation of the external shape of the wearer's head. Other input parameters may represent age, sex, type and severity of deformity, wearer's medical data, planned duration of cranioplasty treatment, head width at various locations, head length, head circumference, shape / circumference percentile of head growth, head diagonal dimensions, or other parameters representing the initial state of the wearer's head. Therefore, the input parameters define the wearer's initial state, especially the data defining the current deformity and influencing the head reshaping process.

[0034] The target external shape of the head is designed based on these input parameters, which are based on the ideal head shape, i.e., the physiological shape of the head, taking into account the planned period for the wearer to wear the craniotomy orthotics. A model of the wearer's initial head shape or external head shape shows the areas and types of deformities that need correction. The most common corrections are for head symmetry defects—plague, head proportion defects—brachycephaly, or a combination of symmetry and proportion defects—so-called complex deformities. At the center of the 3D model of the wearer's initial external head shape and the 3D model of the target external head shape, in some areas the 3D model of the target external head shape is above the area of ​​the 3D model of the initial external head shape, where head growth will be supported; in other areas the area of ​​the 3D model of the target external head shape is merged with the area of ​​the 3D model of the initial external head shape, where growth will be at least partially restricted.

[0035] The step of determining the target inner wall of a craniotomy is based on the step of determining the target outer shape of the wearer's head, wherein the final shape of the target inner wall is determined to achieve the target outer shape of the wearer's head. In some embodiments, the shape of the target inner wall of the craniotomy may directly correspond to the target outer shape of the wearer's head. In other embodiments, its shape may vary; for example, the target inner wall of the craniotomy may be smaller in some areas, or may represent a shape with a smaller head volume, wherein in these "reduced" areas, the target inner wall of the craniotomy includes flexible areas that provide a firmer and more stable fit of the orthosis on the head, while at the same time, due to their flexibility, these areas support head growth to some extent.

[0036] The steps of designing a model of a cranioid orthosis further include designing an outer shell. This outer shell is designed to form a sufficient structural basis for a specific implementation of the inner wall of the cranioid orthosis. In embodiments where the inner wall of the outer shell forms the target inner wall of the cranioid orthosis, it is evaluated whether any additional layers (such as a liner) will be implemented on the outer shell. These layers and additional elements within the orthosis's cavity affect the shape of the cavity of the cranioid orthosis into which the wearer's head is inserted (whether targeted or reduced), and thus affect its function as a reshaping tool. All this information must be processed to create a customized liner and shell that together form an ideal inner wall of the cranioid orthosis that is both comfortable and represents an ideal reshaping tool for achieving the physiological shape of the head. Therefore, in some embodiments, the outer shell or its surface may be increased in thickness to correspond to the shape of the target inner wall of the cranioid orthosis, corresponding to a given additional layer (such as a liner), such that they together form a shape corresponding to the target inner wall of the cranioid orthosis. In other words, the inner wall of the outer shell does not necessarily correspond to the shape of the target inner wall of the craniotomy, wherein the final shape of the target inner wall of the craniotomy is achieved by placing an additional layer on the inner wall of the outer shell. In embodiments without an additional layer, the shape of the inner wall of the outer shell can directly correspond to the target outer shape of the wearer's head.

[0037] Next, the step of designing the model of the cranioplasty includes determining the reduced inner wall of the cranioplasty. This step of determining the reduced inner wall of the cranioplasty occurs similarly to the step of determining the target inner wall of the cranioplasty, except that it is not based on the target external shape of the wearer's head, but rather on the shape of a specific intermediate growth stage between the initial external shape of the wearer's head and the target external shape. Therefore, it can be said that the reduced inner wall of the cranioplasty is designed based on a reduced model of the external shape of the wearer's head corresponding to this intermediate growth stage. Thus, the step of determining the reduced inner wall of the cranioplasty includes comparing a model of the external shape of the wearer's head with a representation of the target external shape of the wearer's head. In various embodiments, the representation of the target external shape of the wearer's head may refer to the target external shape of the wearer's head in digital or physical form, the target inner wall of the cranioplasty, and the target cavity of the cranioplasty. In some embodiments, a cranioplasty with a target inner wall can be formed prior to the design and manufacture of the inner shell, wherein in this case, a representation of the target external shape of the wearer's head may already be the target inner wall of the formed cranioplasty. In such embodiments, for example, a suitable reduced inner wall of the cranioplasty or inner shell can be determined by trial and error using a pre-manufactured inner shell, wherein optimal fit is tested in a comparison step. Thus, the steps of determining the reduced inner wall of the cranioplasty and designing and manufacturing the inner shell can occur simultaneously, or they can be completely combined into one step. However, preferably, the comparison step occurs in digital form, wherein the model is centered, and the step of determining the reduced inner wall of the cranioplasty occurs based on the space between a region of the digital 3D model of the initial shape of the wearer's head and the digital 3D model representation of the target external shape of the wearer's head.

[0038] In some embodiments, the shape of the reduced inner wall of the cranioid orthosis may directly correspond to the reduced outer shape of the wearer's head. In other embodiments, its shape may differ; for example, the reduced inner wall of the cranioid orthosis may be smaller in some areas, or may represent a shape with a smaller head volume. In these "reduced" areas, the reduced inner wall of the cranioid orthosis includes flexible areas that provide a firmer and more stable fit of the orthosis on the head, while at the same time, due to their flexibility, these areas support head growth to some extent.

[0039] In the step of determining the reduced inner wall of the craniotomy, the shape of the reduced inner wall of the craniotomy can be designed by averaging the area of ​​a model of the wearer's external head shape with the area representing the target external shape of the wearer's head. Therefore, the 3D model of the reduced inner wall of the craniotomy is formed by points corresponding to the average of these coordinates representing the initial and target shapes of the wearer's head. In other embodiments, the reduced inner wall can be designed such that it is not exactly in the middle between these areas as in the case of averaging, but closer to the area forming the initial external shape of the wearer's head or closer to the area forming the target external shape of the wearer's head, wherein the reduced inner wall is preferably located at 1 / 3 to 2 / 3 of the distance from the area of ​​the initial model of the wearer's head to the area of ​​the target model. More preferably, the shape of the reduced inner wall of the craniotomy is located at 1 / 3 to 1 / 2 of the distance from the area of ​​the initial model of the wearer's head to the area of ​​the target model. In a specific size, the maximum gap between the model of the wearer's external head shape and the representation of the wearer's head target shape at the deformation location typically reaches 10 mm to 25 mm. Specifically, when the gap between the model of the wearer's external head shape and the representation of the wearer's head target shape at the deformation location is 10 mm, the distance of the reduced inner wall of the craniotomy in the corresponding area can be 3.33 mm to 5 mm, and when the gap is 25 mm, this distance can be 8.33 mm to 12.5 mm. In other areas, the distance between the model of the wearer's external head shape and the representation of the wearer's head target shape decreases in the direction from the area of ​​maximum deformation, and the distance relative to the reduced inner wall of the craniotomy decreases accordingly, depending on a given ratio.

[0040] The method for designing the reduced inner wall of the craniotomy as presented in the preceding paragraphs is suitable for uniformly supporting growth in all deformation zones, wherein the symmetry of the head (and possibly also the proportions of the head) is corrected by growth into the target inner wall of the craniotomy. In other preferred embodiments, for combined deficiencies in the symmetry and proportions of the wearer's head, the reduced inner wall of the craniotomy can be designed such that it corresponds to the external shape of the wearer's head with corrected symmetry, wherein the inner shell of the craniotomy and the resulting reduced cavity first address the symmetry of the head, and then, after the inner shell is removed, the head grows into the target cavity of the craniotomy to address the proportions of the head. In other embodiments, the proportions of the head can be addressed first, followed by the symmetry of the head.

[0041] The steps of designing the inner shell are based on the steps of designing the outer shell and on the steps of determining the reduced inner wall of the cranioplasty and / or determining the target inner wall of the cranioplasty. As part of the design of the inner shell, a specific implementation of the corresponding outer shell for which the inner shell is designed is evaluated. In the step of designing the inner shell, it is evaluated whether any additional layers (such as linings) will be implemented on the inner shell. These layers and additional elements within the cavity of the orthosis affect the shape of the cavity of the cranioplasty into which the wearer's head is inserted (whether targeted or reduced), and thus affect its function as a reshaping tool. All this information must be processed to create a customized lining and shell that together form an ideal inner wall of the cranioplasty that is both comfortable and represents an ideal reshaping tool for achieving a healthy head shape. Therefore, in some embodiments, the inner shell or its surface may be increased in thickness corresponding to the reduced inner wall of the cranioplasty, such that they together form a shape corresponding to the reduced inner wall of the cranioplasty. In other words, the surface of the inner shell does not necessarily correspond to the shape of the reduced inner wall of the craniotomy, wherein the final shape of the reduced inner wall of the craniotomy is achieved by placing an additional layer on the surface of the inner shell. In embodiments without an additional layer, the shape of the surface of the inner shell can directly correspond to the reduced outer shape of the wearer's head.

[0042] In an embodiment in which the inner shell is connected to the inner wall of the target inner wall of the craniotomy, the inner shell is structured such that, after connection, the surface of the outer shell continuously follows the surface of the inner wall of the outer shell, while the surface of the outer shell corresponds to the corresponding reduced inner wall of the craniotomy.

[0043] In one embodiment of the cranioplasty of the present invention, which is part of an assembly having at least two replaceable inner shells, the inner shells being designed such that the two shells can be removably connected to an outer shell of the cranioplasty. One such replaceable inner shell may be designed based on a reduced shape of the inner wall of the cranioplasty, and the other such replaceable inner shell may be designed based on a target shape of the inner wall of the cranioplasty. Thus, in these embodiments, the step of designing the inner shells includes designing at least two inner shells based on the steps of determining the reduced inner wall of the cranioplasty and determining the target inner wall of the cranioplasty.

[0044] Preferably, in the step of designing the inner shell, the inner shell is designed such that it exists only in the space between the target inner wall of the cranioplasty and the model of the external shape of the wearer's head. The inner shell is preferably primarily used to reduce the space between the target inner wall of the cranioplasty and the model of the external shape of the wearer's head, where in other areas they would exert unnecessary pressure on the wearer. In this way, the inner shell can be designed and manufactured in addition to the already formed cranioplasty (which already forms the target inner wall of the cranioplasty).

[0045] Preferably, in the comparison step, a digital 3D model of the wearer's external head shape is compared with a digital 3D model of the target inner wall of the craniotomy. In this way, these models can be easily compared, and the reduced inner wall of the craniotomy can be designed more accurately without significant deviation.

[0046] Preferably, the method for designing and manufacturing a cranioplasty orthosis includes the step of obtaining input parameters, wherein the input parameters are a model of the external shape of the wearer's head and at least one parameter from the set of: age, sex, type and severity of deformity, planned duration of cranioplasty treatment, head width, head length, head circumference, percentile of head growth circumference, and head diagonal dimension, wherein in the step of designing the model of the cranioplasty orthosis, the model of the cranioplasty orthosis is designed based on the input parameters. Age, among other factors, determines head size, its physiological shape, and head growth rate. These data can be used to improve the accuracy of the model of the inner wall of the cranioplasty orthosis, wherein the head growth rate determines when the head will grow to a reduced shape and target shape, thereby allowing for precise timing of the reshaping process and expert follow-up. The planned duration of treatment, particularly in combination with the growth rate, forms the data upon which the specific implementation of the inner wall of the cranioplasty orthosis is based. The percentile of head growth circumference is data that determines the head's growth curve over time, and it is also data suitable for the specific implementation of the inner wall of the cranioplasty orthosis. The type and severity of the deformation can also be used to improve the accuracy of the cranial orthosis model, which can therefore be reflected in the specific implementation of the inner wall of the cranial orthosis, particularly through the specific implementation of the lining, the flexible area and / or the distance between the inner wall of the cranial orthosis and the wearer's head in the deformation area.

[0047] Preferably, the step of producing the inner shell is performed by a 3D printing method. The 3D printing method makes it possible to produce the inner shell of the present invention at minimal initial cost.

[0048] Preferably, in the step of determining the reduced inner wall of the cranial orthosis, the reduced inner wall of the cranial orthosis is determined such that the volume between the model of the wearer's external head shape and the reduced inner wall of the cranial orthosis is 10% to 90% smaller than the volume between the model of the wearer's external head shape and the target inner wall of the cranial orthosis. More preferably, the volume between the model of the wearer's external head shape and the reduced inner wall of the cranial orthosis is 40% to 60% smaller than the volume between the model of the wearer's external head shape and the target inner wall of the cranial orthosis. Attached Figure Description

[0049] An overview of the invention is further illustrated by using exemplary embodiments of the invention described with reference to the accompanying drawings, in which:

[0050] Figure 1 A lateral cross-sectional view of a cranial reshaping orthosis according to a first exemplary embodiment of the present invention is shown.

[0051] Figure 2 A top cross-sectional view of a cranial reshaping orthosis according to a first exemplary embodiment of the present invention is shown.

[0052] Figure 3 This is a perspective view of a cranial remodeling orthosis with an operating opening and a perforated surface of an inner shell according to a first exemplary embodiment of the present invention.

[0053] Figure 4 This is a perspective view of an alternative embodiment of a craniotomy orthosis with an inner shell according to a first exemplary embodiment of the invention, wherein the inner shell has a perforated surface but no operating opening.

[0054] Figure 5 This is a perspective view of an alternative embodiment of a cranioplasty orthosis with an inner shell having no perforated surface, according to a first exemplary embodiment of the invention.

[0055] Figure 6 A lateral cross-sectional view of a cranial reshaping orthosis according to a second exemplary embodiment of the present invention is shown.

[0056] Figure 7 A top cross-sectional view of a cranial reshaping orthosis according to a second exemplary embodiment of the present invention is shown.

[0057] Figure 8 This is a perspective view of a cranial reshaping orthosis according to a second exemplary embodiment of the present invention.

[0058] Figure 9 A lateral cross-sectional view of a cranial reshaping orthosis according to a third exemplary embodiment of the present invention is shown.

[0059] Figure 10 A top cross-sectional view of a cranial reshaping orthosis according to a third exemplary embodiment of the present invention is shown.

[0060] Figure 11 This is a perspective view of a cranial reshaping orthosis according to a third exemplary embodiment of the present invention.

[0061] Figure 12 A lateral cross-sectional view of a cranial reshaping orthosis according to a fourth exemplary embodiment of the present invention is shown.

[0062] Figure 13 A top cross-sectional view of a cranial reshaping orthosis according to a fourth exemplary embodiment of the present invention is shown.

[0063] Figure 14 This is a perspective view of a cranial reshaping orthosis according to a fourth exemplary embodiment of the present invention.

[0064] Figure 15 A lateral cross-sectional view of a cranial reshaping orthosis according to a fifth exemplary embodiment of the present invention is shown.

[0065] Figure 16 A top cross-sectional view of a cranial reshaping orthosis according to a fifth exemplary embodiment of the present invention is shown.

[0066] Figure 17 This is a perspective view of a cranial reshaping orthosis according to a fifth exemplary embodiment of the present invention.

[0067] Figure 18 A lateral cross-sectional view of a cranial reshaping orthosis according to a sixth exemplary embodiment of the present invention is shown.

[0068] Figure 19 A top cross-sectional view of a cranial reshaping orthosis according to a sixth exemplary embodiment of the present invention is shown.

[0069] Figure 20 A lateral cross-sectional view of a cranial reshaping orthosis according to a seventh exemplary embodiment of the present invention is shown.

[0070] Figure 21 A top cross-sectional view of a cranial reshaping orthosis according to a seventh exemplary embodiment of the present invention is shown.

[0071] Figure 22 This is a perspective view of a cranial reshaping orthosis according to a seventh exemplary embodiment of the present invention.

[0072] Figure 23 A lateral cross-sectional view of a cranioplasty according to an eighth exemplary embodiment of the present invention is shown, wherein the inner shell defines a reduced cavity for the cranioplasty.

[0073] Figure 24 A top cross-sectional view of a cranioplasty according to an eighth exemplary embodiment of the present invention is shown, wherein the inner shell defines a reduced cavity for the cranioplasty.

[0074] Figure 25 A lateral cross-section of a cranioplasty orthosis according to an eighth exemplary embodiment of the present invention is shown, wherein the inner shell defines a target cavity for the cranioplasty orthosis.

[0075] Figure 26 A top cross-sectional view of a cranioplasty according to an eighth exemplary embodiment of the present invention is shown, wherein the inner shell defines the target cavity of the cranioplasty.

[0076] Figure 27 A lateral cross-sectional view of a cranioplasty orthosis is shown, in which the outer shell defines the target cavity of the cranioplasty orthosis without an inner shell.

[0077] Figure 28 A top cross-sectional view of a cranioplasty orthosis is shown, in which the outer shell defines the target cavity of the cranioplasty orthosis without an inner shell.

[0078] Figure 29 The diagram shows a centered (initial) model of the wearer's head's external shape, a model of the wearer's head's reduced external shape, and a model of the wearer's head's target external shape. Detailed Implementation

[0079] The cranial reshaping orthosis of the present invention will be further illustrated using exemplary embodiments with reference to the accompanying drawings.

[0080] A first exemplary embodiment of the basic components of the present invention and their arrangement therein Figure 1 , Figure 2 and Figure 3The following is an example. A first exemplary embodiment of a craniocerebral orthosis includes an outer housing 1, which includes an inner wall 2 defining an inner cavity of the craniocerebral orthosis, wherein both the outer housing 1 and the inner housing 4 are made of a 3D printing material (especially polyamide). Here, the inner wall 2 of the outer housing represents a target inner wall 10 of the craniocerebral orthosis, wherein the target cavity of the craniocerebral orthosis corresponds to the inner cavity 3 of the outer housing. The inner housing 4 is adhesively attached to the inner wall 2 of the outer housing. A liner 13 is placed on the surface 6 of the inner housing and on an adjacent area of ​​the inner wall 2 of the outer housing, wherein the liner 13 and the inner housing 4 together reduce the volume of the inner cavity 3 of the outer housing to a reduced inner cavity 5 of the craniocerebral orthosis. The inner housing 4 defines a space for reducing the target inner cavity 11 of the craniocerebral orthosis (the inner cavity 3 of the outer housing), wherein the resulting reduced inner wall 12 of the craniocerebral orthosis is represented by the surface of the liner 13. In the design of the inner shell 4, the thickness of the liner 13 is taken into account such that when the liner 13 is inserted, they together form the resulting reduced inner wall 12 of the cranioplasty. The inner shell 4 includes a perforated surface 6 of the inner shell, including an operating opening 14 in the surface 6 of the inner shell for facilitating removal of the inner shell 4 from the outer shell 1. The first exemplary cranioplasty is a two-piece design, wherein it includes a front member of the shell ( Figure 1 (left part) and rear component ( Figure 1 The inner wall 2 of the outer shell (right part of the inner shell) together forms the outer shell 1. A liner 13 is provided on the inner wall 2 of the front part of the outer shell, wherein the inner wall 2 of the outer shell on the front member and the corresponding liner 13 together partially form the target inner wall 10 and the reduced inner wall 12 of the cranioid orthotine. Therefore, in this embodiment of the invention, the difference between the target inner wall 10 and the reduced inner wall 12 of the cranioid orthotine is formed only by the inner shell 4 and the liner 13 on the rear member of the cranioid orthotine.

[0081] The inner wall 2 of the outer shell of the rear member can also be adapted to its shape for placing the liner 13, wherein together they can thus form the target inner wall 10 of the craniotomy on the rear member of the outer shell 1. In this embodiment, Figure 1 and Figure 2 The illustrated liner 13 can be formed simultaneously after the removal of the inner shell 4, and the liner 13 together with the inner wall 2 of the outer shell of the rear member forms the target inner wall 10 of the craniotomy.

[0082] exist Figure 2 On model 8, which illustrates the external shape of the head, it can be seen that the head is located in the right rear part ( Figure 2 The upper left of the image includes a significant deformation that points towards the left rear side of the head. Figure 2 The upper right corner of the head decreases, while the head has a nearly physiological target shape on the upper left rear side. For example... Figure 2As can be seen, the reduced inner cavity 5 is designed based on the wearer's external head shape with corrective symmetry. The difference between the reduced inner wall 12 and the target inner wall 10 of the craniotomy is only in the length of the head, where the target inner wall 10 is slightly more concave, and their left and right sides are symmetrical, as shown. Figure 2 The upper cross-sectional view is visible. After achieving a shape that approximates the shape of the reduced inner wall 12 of the cranial orthosis, a near-corrected symmetry of the head is thus expected. Therefore, the target inner wall 10 is subsequently adapted to correct the proportions of the head.

[0083] In an alternative embodiment of the cranioid device according to the first exemplary embodiment of the invention, the target inner wall 10 of the cranioid device or the inner wall 2 of the outer shell may be designed to be provided with a liner 13, which is inserted into the cavity after the inner shell 4 is removed. In this embodiment, the inner wall 2 of the outer shell is larger in size to correspond to a given additional layer (such as the liner 13) such that when the layers are inserted together, they form the final target inner wall 10 of the cranioid device.

[0084] In an alternative embodiment of the craniotomy device according to the first exemplary embodiment of the present invention, the inner housing 4 does not include the operating opening 14 in the surface 6 of the inner housing. Such embodiments... Figure 4 Example in.

[0085] exist Figure 5 In an alternative embodiment of the cranial orthosis of the first exemplary embodiment of the present invention, the inner housing 4 does not include the perforated surface 6 of the inner housing.

[0086] The cranioplasty device of the second exemplary embodiment is in Figure 6 to Figure 8 The following is an example. This embodiment differs from the first embodiment in that the inner shell 4 is connected to the outer shell 1 via a liner 13, which is disposed on the outer shell 1 at the mounting position of the inner shell 4. The inner shell 4 is connected to the liner 13 by double-sided adhesive tape. Therefore, the target inner wall 10 of the cranioid orthotine in this embodiment refers to the surface of the liner 13 on the inner side of the outer shell, and the reduced inner wall 12 of the cranioid orthotine is formed by the surface 6 of the inner shell and the surface of the liner 13 not covered by the inner shell 4 on the inner wall 2 of the outer shell.

[0087] The cranioplasty device of the third exemplary embodiment is in Figure 9 to Figure 11The following is an example. This embodiment differs from the first exemplary embodiment in that the reduced inner wall 12 of the craniotomy corresponds to a direct intermediate growth stage between the initial external shape of the wearer's head and the target external shape 9 of the wearer's head. Therefore, the area of ​​the reduced inner wall 12 of the craniotomy corresponds to the average of the area of ​​the model 8 representing the external shape of the wearer's head and the area of ​​the model representing the target external shape 9 of the wearer's head. Thus, the reduced inner wall 12 of the craniotomy, or the reduced model 8 of the wearer's external shape, corresponds to a head shape exhibiting signs of asymmetry and proportional defects, where both symmetry and proportion are corrected solely by the target inner wall 10 of the craniotomy.

[0088] The cranioplasty of the fourth exemplary embodiment is in Figure 12 to Figure 14 The following is an example. This embodiment differs from the third exemplary embodiment in that it includes a larger inner shell 4, wherein the difference between the reduced inner cavity 5 and the target inner cavity 11 is greater than that in the third exemplary embodiment. The surface 6 of the inner shell of the fourth exemplary embodiment follows the inner wall of the craniocerebral orthosis more continuously, and the craniocerebral orthosis is more comfortable to wear because the reduced inner wall 12 of the craniocerebral orthosis better corresponds to the actual shape of the wearer's head. In this embodiment, the inner shell 4 is attached to the inner wall 2 of the outer shell by double-sided adhesive tape.

[0089] The cranioplasty of the sixth exemplary embodiment is in Figure 15 to Figure 17 As illustrated in the diagram. In this embodiment, the cranial reshaping orthosis is adapted to correct deformation of the anterior portion of the head. The inner shell 4 is connected to the inner wall 2 of the outer shell of the anterior member. The inner shell 4 completely fills the space between the surface 6 of the inner shell and the inner wall 2 of the outer shell, wherein the inner shell is made of 3D-printed thermoplastic elastomer.

[0090] The cranioplasty of the sixth exemplary embodiment is in Figure 18 to Figure 19 The following is an example. This embodiment differs from the first exemplary embodiment in that the inner shell 4 includes a mesh 3D structure 7 that fills the space between the surface 6 of the inner shell and the inner wall 2 of the outer shell. The inner shell 4 is made of a 3D-printed thermoplastic elastomer, which thus possesses elastic properties, further increasing the flexibility of the reduced inner wall 12 in contact with the wearer's head, making the cranioplasty more comfortable.

[0091] The cranioplasty of the seventh exemplary embodiment is in Figure 20 to Figure 22 As illustrated in the figure. The cranial remodeling orthosis is particularly characterized in that it is part of an arrangement comprising two different internal shells 4. Figure 20A cross-sectional view of a cranioplasty orthosis according to a seventh exemplary embodiment is shown, wherein a first inner shell 4 defines a reduced cavity 5 of the cranioplasty orthosis. The first inner shell 4 is mechanically connected circumferentially to an outer shell 1 via a groove-protrusion type connection, wherein the inner shell 4 is made of thermoplastic elastomer by 3D printing, and wherein it defines both grooves and protrusions in its shape at the connection location, where the outer shell 1 also defines corresponding grooves and protrusions in its shape at that location. The first inner shell 4 includes a perforated surface 6 of the inner shell and a mesh 3D structure 7 following the surface 6 of the inner shell, the mesh 3D structure filling the space between the surface 6 of the inner shell and the inner wall of the cranioplasty orthosis. In this embodiment, both the mesh 3D structure 7 and the surface 6 of the inner shell are formed of an elastic thermoplastic elastomer, wherein the entire inner shell 4 represents a flexible area that elastically deforms when forces are applied to the surface 6 of the inner shell. In an alternative embodiment, the mesh 3D structure 7 is formed of a more rigid material, wherein it forms a support for the surface 6 of the inner shell. Figure 20 and Figure 21 The illustrated model 8 of the external shape of the wearer's head is a reduced external shape of the wearer's head, wherein the model 8 corresponds to the reduced inner wall 12 of the craniotomy, thus illustrating the model 8 of the head when the head has grown into the reduced inner cavity 5 of the craniotomy and it is about time to replace the first inner shell 4 with the second inner shell 4 that defines the target inner cavity 11 of the craniotomy.

[0092] The cranioplasty of the eighth exemplary embodiment is in Figure 23 to Figure 26 The eighth embodiment is illustrated in the diagram. Similar to the seventh exemplary embodiment of the invention, the eighth embodiment is characterized in that the cranioplasty is part of an assembly of a cranioplasty remodeling orthosis, the assembly including a first inner shell 4 defining a reduced inner wall 12 of the cranioplasty and a second inner shell 4 defining a target inner wall 10 of the cranioplasty. The two inner shells 4 are adapted to place a liner 13 on their surfaces, wherein the two inner shells together with the liner 13 form the inner wall of the cranioplasty. The cranioplasty of the eighth exemplary embodiment having the first inner shell 4 is... Figure 23 and Figure 24 The first inner shell 4 is formed by a surface wall that defines a surface 6 of the inner shell and is adjacent along its circumference to a corresponding region formed by the structure of the outer shell 1, wherein these regions of the inner shell 4 and the outer shell 1 are connected via double-sided adhesive tape. In an alternative embodiment, these regions are mechanically connected by a pin-groove connection. The surface of the first inner shell 4 is shaped to form, together with the liner 13, a reduced inner wall 12 of the cranioid orthotium. The cranioid orthotium of the eighth exemplary embodiment having a second inner shell 4... Figure 25 and Figure 26As illustrated in the diagram. The second inner shell 4 is structurally identical to the first inner shell 4, except for its surface shape. This is because the surface shape of the second inner shell 4 is adapted to form the target inner wall 10 of the cranial orthotine together with the liner 13.

[0093] All figures of the eighth embodiment of the present invention ( Figure 23 to Figure 26 The initial model 8 of the external shape of the wearer's head is also shown, in which it can be observed how the first inner shell and the second inner shell 4 change the size of the space between the initial external shape of the wearer's head and the given inner wall of the cranial orthotist.

[0094] This document will use specific implementations to describe the method of designing and manufacturing the cranial reshaping orthosis of the present invention.

[0095] In an exemplary embodiment of the method for designing and manufacturing the cranioplasty orthosis of the present invention, in the step of obtaining a model 8 of the external shape of the wearer's head, the wearer's head is scanned by a scanning device, wherein the created 3D scan image is stored in the memory of a computer device. This 3D scan image of the wearer's head represents an initial model 8 of the external shape of the wearer's head. The description of the relationships between the various digitized regions (model 8 of the external shape of the wearer's head, regions corresponding to the inner walls of the cranioplasty orthosis, ...) relates to their centered positions relative to the initial model 8 of the external shape of the wearer's head, illustrative examples of which are shown in... Figure 29 Example in.

[0096] The input parameters further include information that the target inner wall 10 of the craniocerebral orthosis will be provided with a 5mm liner 13 and information on preferably correcting the symmetry of the head and then correcting the proportions of the head. Based on the model 8 of the external shape of the wearer's head, the target external shape 9 of the wearer's head is further designed and then modified into the final embodiment of the target inner wall 10 of the craniocerebral orthosis. Now, the shape of the target inner wall 10 of the craniocerebral orthosis is known, and the design of the outer shell 1 on the computer device follows such that the resulting craniocerebral orthosis has the target shape of the inner wall of the craniocerebral orthosis. A liner 13 with a thickness of 3 mm will be placed on the inner wall of the craniocerebral orthosis, i.e., on the inner wall 2 of the outer shell, which (which together with the liner 13 defines the target inner cavity 11 of the craniocerebral orthosis) thus adds 3 mm to the area defining the target inner cavity 11 of the craniocerebral orthosis, wherein the difference between the area defining the target inner cavity 11 of the craniocerebral orthosis and the area defining the inner wall 2 of the outer shell corresponds to the size of the liner 13. Therefore, the lining 13 placed on the inner wall of the cranioplasty reduces the inner cavity 3 of the outer shell to a cavity corresponding to the target inner cavity 11 of the cranioplasty. Thus, the entire inner shell 4 can now be designed, structurally based on the defined shape of the inner wall 2 of the outer shell, to provide sufficient robustness and stability for the cranioplasty structure. Subsequently, the outer shell 1 is produced by 3D printing.

[0097] The outer shell 1 produced to define the target cavity 11 of the craniotomy device is in Figure 27 and Figure 28 As illustrated, a significant gap is visible between the initial model 8 of the wearer's head's external shape and the target inner wall 10 of the craniotomy, resulting in undesirable rotation of the craniotomy around the wearer's head. Therefore, the inner shell 4 is subsequently designed to reduce this volume, and it is based on either a reduced external shape of the wearer's head or a reduced inner wall 12 of the craniotomy.

[0098] The next step is to determine the reduced inner wall 12 of the cranial orthopedic device, which is located within... Figure 29 The diagram illustrates this schematically. The step of determining the reduced inner wall 12 of the cranial orthotist includes comparing a model 8 of the wearer's head's external shape with a representation of the wearer's head's target external shape 9, wherein the initial external shape of the wearer's head is first compared with the target external shape 9 of the wearer's head. Figure 29As can be seen, the wearer's head exhibits significant deformation in the right posterior region of the head, which disrupts the overall symmetry and proportions of the head. The reduced inner wall 12 of the craniocerebral orthosis will correspond to the shape of the head with corrected symmetry, where the proportion defect will subsequently be addressed by allowing the head to grow into the target cavity 11 of the craniocerebral orthosis. In this embodiment, the reduced inner wall 12 of the craniocerebral orthosis is formed by modifying the target inner wall 10 of the craniocerebral orthosis, which is modified by shifting it toward a model of the initial external shape of the wearer's head while maintaining a symmetrical shape. The reduced inner wall 12 of the craniocerebral orthosis is designed here such that it divides the volume between the region corresponding to the initial external shape of the wearer's head and the region corresponding to the target external shape 9 of the wearer's head into two approximately equal cavities (see [link to relevant documentation]). Figure 29 ).

[0099] The next step is to design the inner shell 4 based on the reduced inner wall 12 of the cranioplasty. The inner shell 4 will not have a liner 13 or any other supplementary layer, wherein the surface 6 of the inner shell will correspond as closely as possible to the surface of the reduced inner wall 12 of the cranioplasty. Therefore, the inner shell 4 is designed such that its surface completely corresponds to the reduced inner wall 12 of the cranioplasty at locations different from the target inner wall 10 of the cranioplasty; at their overlapping locations, the reduced inner wall 12 of the cranioplasty is formed by the liner 13 on the inner wall 2 of the outer shell. The inner shell 4 is adapted to be connected to the outer shell 1 via its liner 13, wherein the inner shell includes a contact area around its circumference corresponding to the liner 13 at a given location on the outer shell 1, wherein the contact area and the liner are connected by double-sided adhesive tape.

[0100] Subsequently, the inner shell 4, designed by 3D printing, is attached to the outer shell 1 in front of the lining 13 by double-sided adhesive tape, thus completing the production of the cranial orthotist.

[0101] The product obtained by the exemplary design and manufacturing method according to the present invention is based on Figure 6 to Figure 8 The skull orthopedic device of the second exemplary embodiment illustrated.

[0102] In the examples of the above design and manufacturing methods, it can be seen that the steps of designing and manufacturing the outer shell 1 and the steps of designing and manufacturing the inner shell 4 can occur at different times. In an alternative embodiment, the inner shell 4 can be designed first, followed by the design of a suitable outer shell 1 for it. This may be preferred, for example, in the methods of designing and manufacturing cranioids of the seventh and eighth embodiments, which are part of a cranioid assembly having two inner shells 4. In these, based on the determined reduced inner wall 12 and target inner wall 10 of the cranioid, it is necessary to design a first inner shell and a second inner shell 4 suitable for the same removable connection with the outer shell 1, after which the outer shell 1 representing the rest of the structure of the cranioid can be designed, thereby providing structural stability and robustness of the cranioid.

[0103] Industrial applicability

[0104] This invention can be applied to the field of reshaping orthotics.

[0105] List of reference signs

[0106] 1-Outer casing

[0107] 2-Inner wall of the outer casing

[0108] 3-Inner cavity of the outer casing

[0109] 4-Inner shell

[0110] 5-Reduced internal cavity of cranial orthotics

[0111] 6- Surface of the inner shell

[0112] 7-Mesh 3D Structure

[0113] 8- Model of the external shape of the head

[0114] 9-Target external shape of the head

[0115] 10-Target inner wall of cranial orthotics

[0116] 11-Target cavity of cranial orthotics

[0117] 12-Reduced inner wall of cranial orthotics

[0118] 13- Lining

[0119] 14-Operating opening.

Claims

1. A cranial reshaping orthosis comprising an outer shell (1) and an inner shell (4), wherein an inner wall (2) of the outer shell defines an inner cavity (3) of the outer shell for insertion into a wearer's head, wherein the inner shell (4) is removably connected to the outer shell (1) and defines a reduced inner cavity (5) for insertion into a wearer's head, the reduced inner cavity having a volume smaller than that of the inner cavity (3) of the outer shell, characterized in that... The inner housing (4) is removably connected to the outer housing (1) at at least two different locations circumferentially distributed around the inner housing (4).

2. The cranial reshaping orthosis according to claim 1, characterized in that... The inner housing (4) is removably connected to the inner wall (2) of the outer housing.

3. The cranial reshaping orthosis according to claim 1 or 2, characterized in that... The cranial remodeling orthosis is part of an assembly of the cranial remodeling orthosis, the assembly further including at least one other inner housing (4) for removable connection to the outer housing (1), wherein each of the at least two inner housings (4) defines a different reduced cavity (5) with a different volume.

4. The cranial reshaping orthosis according to claims 1 to 3, characterized in that... The inner housing (4) includes a perforated surface (6) of the inner housing.

5. The cranial reshaping orthosis according to claims 1 to 4, characterized in that... The inner shell (4) is made of 3D printed material.

6. The cranial reshaping orthosis according to claims 1 to 5, characterized in that... The inner housing (4) further includes a mesh 3D structure (7) between the surface (6) of the inner housing and the inner wall (2) of the outer housing.

7. The cranial reshaping orthosis according to claims 1 to 6, characterized in that... The inner housing (4) is removably connected to the outer housing (1) along most of the circumference of the inner housing.

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