Cranial Remodeling Orthosis.

Description

1 / 38 “METHOD OF DESIGN AND PRODUCTION OF A CRANIAL REMODELING ORTHOSIS”. TECHNICAL FIELD 001 The invention relates to a method of designing and producing a cranial remodeling orthosis, in particular for the treatment of head deformities in newborns, infants and young children. BACKGROUND OF THE INVENTION 002 Cranial remodeling orthoses are used to fix or assist in remodeling the user's head, giving it the proper shape. These orthoses must be precisely adapted to the user's head, both for their comfort and for the proper functioning of the cranial orthosis. 003 For example, newborns, infants, and young children sometimes exhibit undesirable head deformities (usually from frequently lying in the same position), requiring immediate corrective treatment to correct the head shape. These deformities include plagiocephaly, a defect in head symmetry; brachycephaly, a defect in head proportions; or a combination of both (called asymmetrical brachycephaly), in which the head exhibits asymmetry and defective proportions. Plagiocephaly manifests, for example, as asymmetrical flattening at the back of the head, prominence of the forehead on the side of the posterior flattening, anterior displacement of the ear on the side of the posterior flattening, or asymmetry in facial position. Brachycephaly manifests as symmetrical flattening at the back of the head, a wider head, or a higher skull when viewed from above.The combination of these two types of deformity manifests as bilateral flattening of the back of the head, where one side of the head is flatter than the other, and the forehead is displaced forward on the side with greater flattening at the back of the head. Petition 870260058976, dated 06 / 17 / 2026, page 6 / 47 2 / 38 skull, or the ear is displaced forward on the side of the greater occipital flattening. 004 These defects can be treated with the use of a cranial orthosis. This orthosis has an internal cavity to receive the head, specifically designed to match the shape the head should have at the end of treatment. This orthosis then directs the correction of the head shape during growth. This means that, in some places, the inner wall of the cranial orthosis shell is not in contact with the head, so that head growth is supported in these locations, while in places where the inner wall of the cranial orthosis shell is in contact with the head, head growth is limited.However, ensuring this ideal shape of the inner wall of the shell, which guarantees proper growth, results in the fact that the cranial orthosis, by the nature of its function, does not fit firmly to the user's head, where unwanted rotations of the orthosis in relation to the head frequently occur, resulting in less comfort for the user and less effectiveness of the treatment with the cranial orthosis. 005 Currently, there are several solutions to ensure a better fit of the cranial orthosis to the user's head. The problem of a better fit of the orthosis to the user's head is often solved by the fact that the shape of the inner wall of the shell is not adapted to the target shape that the head should have, but only corresponds to a certain intermediate stage of growth towards the target shape. In such solutions, the shape of the inner cavity of the shell is adjusted so that the gap between the head and the inner wall of the shell is reduced at the sites of deformation, so that the orthosis does not allow such large unwanted rotational movements and, at the same time, growth is supported at the determined location, i.e., the head is not yet in contact with the inner wall of the shell at the site of the deformation.The main disadvantage of this solution is that the cranial orthosis needs to be replaced frequently, as the head grows up to the inner wall of the concha in the location of the... Petition 870260058976, dated 06 / 17 / 2026, page 7 / 47 3 / 38 deformation, a new orthosis needs to be created to provide space for growth again at the site of the deformation. Thus, a large number of cranial orthoses must be used in the treatment process, corresponding to different intermediate stages of growth until the desired physiological shape of the head is achieved. The treatment, therefore, requires a large amount of materials for the production of different shells, demands more time from specialists to plan the entire treatment, and the user frequently needs to attend medical appointments, making the treatment significantly more complex and expensive. 006 These costs are reduced in solutions where the structure is made of a material that can be internally polished, where the specialist polishes the inner part of the cranial orthosis during treatment, so that the internal shape supports growth in the areas of deformation. Based on continuous checks, the inner part of the orthosis is gradually polished until it reaches the ideal shape that the head should have. This process is technologically demanding and requires a high level of specialization; it is not possible to simply monitor and predict the course of treatment, always needing to react to the actual shape of the user's head during the check. Furthermore, in the initial stages of wear, the cranial orthosis is very heavy, as it needs to incorporate all the material that is gradually polished, which can lead to complications in the development of the neck and spine, potentially leading to injuries. 007 Another partial solution to the aforementioned problems is a cranial orthosis with adjustable fixation, for example, according to document WO2019115965 A1. By means of the adjustable fixation of the helmet laterally, it can be gradually opened as the head grows to the current volume of the shell's interior. There is no need to modify the helmet in any way or to constantly create new helmets. However, such a solution can only be applied to certain types of deformities and its effectiveness is significantly limited. Furthermore, it is a Petition 870260058976, dated 06 / 17 / 2026, page 8 / 47 4 / 38 This is a structurally demanding solution and there is a risk of unwanted displacement of the fastening mechanism. 008 Another relevant example of the state of the art is document CN 217448164 U, which describes the principle of replacing the inner shell during treatment. 009 Another relevant example of the state of the art is document WO 2018 / 212632 A1, which describes a method for manufacturing a cranial orthosis with an internal shell that is repeatedly reshaped during treatment, according to the current scan of the head. 010 For the reasons stated, it is desirable to develop a cranial remodeling orthosis that fits firmly and comfortably to the user's head, providing the correct treatment for a wide range of different head deformities throughout the period of use of the cranial remodeling orthosis. SUMMARY OF THE INVENTION 011 The above deficiencies are eliminated by a method of designing and producing a cranial remodeling orthosis of the invention, comprising the steps of: a) Obtaining a model of an initial external shape of the user's head, b) Designing a model of the cranial remodeling orthosis based on the model of the initial external shape of the user's head, comprising a step of determining a target external shape of the user's head based on the model of the initial external shape of the user's head and a subsequent step of determining a target internal wall of the cranial orthosis, defining a target internal cavity of the cranial orthosis, where the shape of the target internal wall is determined to achieve the target external shape of the user's head, c) production of the cranial orthosis, in which the design stage of the cranial orthosis model (b) also includes a stage of determining a reduced internal wall of the cranial orthosis, defining a reduced internal cavity of the orthosis. Petition 870260058976, dated 06 / 17 / 2026, page 9 / 47 5 / 38 Cranial orthosis comprising a step of comparing the model of the user's initial external head shape with a representation of the user's target external head shape, wherein the step of designing the cranial orthosis model (b) further comprises a 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, wherein the reduced inner wall of the cranial orthosis corresponds to a certain intermediate stage of growth between the user's initial external head shape and the user's target external head shape, wherein the step of designing the cranial orthosis model (b) further comprises a step of designing an outer shell, wherein the target inner wall of the cranial orthosis is formed entirely by the outer shell,and the stage of producing the cranial orthosis (c) comprises a stage of producing the inner shell and a stage of producing the outer shell. 012 The above deficiencies are also eliminated by a method of designing and producing a cranial remodeling orthosis of the invention, comprising the steps of: a) Obtaining a model of an initial external shape of the user's head, b) Designing a model of the cranial remodeling orthosis based on the model of the initial external shape of the user's head, comprising a step of determining a target external shape of the user's head based on the model of the initial external shape of the user's head and a subsequent step of determining a target internal wall of the cranial orthosis, defining a target internal cavity of the cranial orthosis, where the shape of the target internal wall is determined to achieve the target external shape of the user's head, c) production of the cranial orthosis, in which the design stage of the cranial orthosis model b) also includes a stage of determining a reduced internal wall of the cranial orthosis, defining a reduced internal cavity of the cranial orthosis, including a stage of comparing the model to the external form Petition 870260058976, dated 06 / 17 / 2026, page 10 / 47 6 / 38 initial shape of the user's head with a representation of the target external shape of the user's head, wherein the step of designing the cranial orthosis model b) further comprises a step of designing a first 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 first inner shell, wherein the reduced inner wall of the cranial orthosis corresponds to a certain intermediate stage of growth between the initial external shape of the user's head and the target external shape of the user's head, wherein the step of designing the cranial orthosis model b) further comprises a step of designing a second inner shell based on the step of determining the target inner wall, wherein the target inner wall of the cranial orthosis is at least partially formed by the second inner shell,wherein the step of designing the cranial orthosis model b) further comprises a step of designing an outer shell, in which the first inner shell and the second inner shell are designed to be removablely connected to the outer shell and to be mutually interchangeable, and the step of producing the cranial orthosis c) comprises a step of producing the first inner shell, a step of producing the second inner shell, and a step of producing the outer shell. 013 The product of the method of designing and producing a cranial remodeling orthosis according to the invention is a cranial remodeling orthosis comprising an outer shell, wherein the inner wall of the outer shell defines an inner cavity of the outer shell for insertion of the user's head, further comprising an inner shell that is removablely connected to the outer shell, wherein the inner shell defines a reduced inner cavity for insertion of the user's head, with a volume smaller than the inner cavity of the outer shell. 014 The advantage of the method of designing and producing the cranial remodeling orthosis, according to the invention, is that it results in a cranial remodeling orthosis that fits firmly and comfortably to the user's head, providing adequate treatment for Petition 870260058976, dated 06 / 17 / 2026, page 11 / 47 7 / 38 a wide range of different head deformities, throughout the period of orthosis use. 015 Thus, the structure of the cranial orthosis is composed of at least two parts: the external structure and the internal structure. The external structure refers to the basic load-bearing part of the cranial orthosis, which defines the external shape of the orthosis and ensures sufficient firmness and structural stability. The external structure comprises the inner wall of the external structure, which defines the internal cavity of the external structure and forms the basis for defining the internal cavity of the cranial orthosis, which is adapted to contain the user's head. The internal cavity of the external shell does not mean a cavity within the wall of the external shell, but a cavity that is defined by the shape of the external shell and which, to a certain extent, defines the space to contain the user's head, with the resulting space of the cranial orthosis to contain the user's head being represented by the internal cavity of the cranial orthosis.In various embodiments, the inner wall of the outer shell may be provided with a lining or additional layers, ensuring, for example, greater comfort or safety. The outer shell may be implemented as a thin-walled shell comprising only one envelope or layer, or it may comprise an inner and outer envelope with a 3D mesh structure between them to reinforce the structure, or a combination of these variants. In some embodiments, the inner wall of the outer shell may represent the inner wall of the cranial orthosis, i.e., it may directly define the internal cavity of the cranial orthosis adapted to contain the user's head.In other modalities, the cranial remodeling orthosis may contain additional components placed within the outer shell that form the entire inner wall of the cranial orthosis and, therefore, the internal cavity of the cranial orthosis adapted to contain the user's head, or it may only partially form the inner wall of the outer shell. Thus, the internal cavity of the outer shell may not correspond to the internal cavity of the cranial orthosis in some cases. Petition 870260058976, dated 06 / 17 / 2026, page 12 / 47 8 / 38 modalities, or the inner wall of the outer shell may not correspond to the inner wall of the cranial orthosis in some modalities. 016 The internal cavity of the cranial orthosis for insertion of the user's head means the space within the cranial orthosis that the cranial orthosis surrounds in shape and that is adapted to contain the user's head; this space, therefore, corresponds approximately to the external shape of the user's head. The internal cavity of the cranial orthosis is defined by the shell or other layers placed on the inner wall of the shell, where its orifice corresponds to the marginal contours of the shell which, in cranial remodeling orthoses, run above the eyebrows, then on both sides of the head around the ears and meet in the region of the occipital bone. With its internal shape, the cranial remodeling orthosis, or rather, the internal cavity of the orthosis, corresponds approximately to the shape of the skull in the regions of the frontal bone, parietal bones and occipital bone.On the inner side, the inner and / or outer shell may comprise additional linings or layers placed on the inner walls of the shells for greater comfort or breathability of the cranial orthosis. These additional layers naturally affect the shape of the inner wall of the cranial orthosis and therefore the shape of the inner cavity of the cranial orthosis to contain the head, and these additional layers should be considered in the design of the inner and outer shells. 017 The inner shell can be connected to the outer shell in a removable manner in several ways. For example, the inner shell can be connected directly to the inner wall of the outer shell, so that the inner and outer shells form a continuous piece. In such an embodiment, the inner shell is connected to the outer shell at at least 2 points around its circumference by bridges, preferably at at least 4 points around its circumference, more preferably around its entire circumference. These pins / bridges are thin and fragile compared to the rest of the shell structure, so that when the inner shell is twisted relative to the outer shell, they break and the inner shell can thus be... Petition 870260058976, dated 06 / 17 / 2026, page 13 / 47 9 / 38 removed from the inner cavity of the outer shell. In other embodiments, the inner shell may extend over the margins of the outer shell, and in these embodiments, the inner shell may also be connected to the outer part of the outer shell. Furthermore, the inner shell may be connected to the outer shell by gluing, double-sided adhesive tape, or by a mechanical connection, such as a groove-projection type, or by means of an elastic stop. In some embodiments, the inner shell may be connected to the outer shell by means of a sheath. In other embodiments, the inner shell may be connected to the inner wall of the outer shell. Thus, a removable connection between the inner and outer shells generally means an implementation of their connection that allows the separation of the inner shell from the outer shell without significant damage to the outer shell that would limit the functionality of the cranial orthosis. 018 In addition, the outer shell may be composed of multiple parts that are connected by a fastening mechanism when placed on the user's head. In these embodiments, the description of the inner wall of the cranial orthosis, the inner wall of the outer shell, the inner cavity of the outer shell, and the inner cavity of the cranial orthosis refers to the shell in the assembled position, where all the parts of the outer shell are joined together. 019 In the context of the invention, the cranial orthosis has a variable internal cavity, the size of which can change by removing the inner shell from the outer shell or by replacing one inner shell with another. In this context, two internal cavities of the cranial orthosis are defined: target and reduced. The reduced cavity of the cranial orthosis is defined by the reduced inner wall of the cranial orthosis, and the target cavity of the cranial orthosis is defined by the target inner wall of the cranial orthosis, wherein the reduced cavity of the cranial orthosis has a smaller volume than the target cavity of the cranial orthosis, or the target cavity is adapted to contain the user's head with a larger volume. Thus, in general, the target and reduced cavities of the cranial orthosis correspond to different stages of growth of the Petition 870260058976, dated 06 / 17 / 2026, page 14 / 47 10 / 38 head during remodeling, where the reduced cavity corresponds to the intermediate stage of head growth until the user's target head shape, which corresponds to the target internal cavity of the cranial orthosis. The reduced wall of the cranial orthosis can be formed jointly by the inner and outer shells or entirely by the inner shell; the target wall of the cranial orthosis can be formed jointly by the inner and outer shells, entirely by the inner shell, or entirely by the outer shell. Additional layers, such as the lining of the inner or outer shell, affect the shape of the inner wall or the reduced or target cavity, and the implementation of the inner and / or outer shell must be adapted in its shape to the additional layers provided, so that together they form the necessary shape of the inner wall of the cranial orthosis and, therefore, of the internal cavity of the cranial orthosis. 020 The reduced internal cavity of the cranial orthosis corresponds to the volume of the target internal cavity of the cranial orthosis reduced by the volume removed from the target internal cavity volume by the internal concha. Thus, the reduced internal cavity means the target internal cavity of the cranial orthosis reduced by a specific volume defined by the internal concha inserted into the internal cavity of the external concha. 021 Preferably, the inner shell is removablely connected to the inner wall of the outer shell. In these modalities, the inner wall of the outer shell generally has a concave or convex shape, adapted to the shape of the head and defining the inner cavity of the outer shell, which also corresponds to the target inner cavity of the cranial orthosis. The inner shell preferably has a shape that approximately follows the concavity of the inner wall of the outer shell at the indicated location. The shape of the inner shell is flatter in relation to the shape of the region of the inner wall of the outer shell that the inner shell covers, with an increasing difference between the target inner cavity and the reduced inner cavity, or increasing volume of the inner cavity of the outer shell delimited by the Petition 870260058976, dated 06 / 17 / 2026, page 15 / 47 11 / 38 Inner shell. The inner shell preferably follows continuously the wall of the inner cavity of the outer shell, with the transition between the inner wall of the outer shell and the surface of the inner shell being gradual and smooth for maximum user comfort. In these modalities, the reduced inner wall of the cranial orthosis is formed jointly by the surface of the inner shell, or inner wall of the inner shell, and by the inner wall of the outer shell, and after removal of the inner shell, the target inner wall of the cranial orthosis is formed by the inner wall of the outer shell. 022 In other preferred alternative embodiments, the cranial remodeling orthosis is part of an assembly that also includes at least one other inner shell for removable connection to the outer shell, each of the at least two inner shells defining a different reduced inner cavity with a different volume. In these embodiments, the assembly comprises two mutually replaceable inner shells: the first inner shell and the second inner shell, both adapted for removable connection to the outer shell. The first inner shell may form, at least partially, the reduced inner wall of the cranial orthosis, and, after replacement, the second inner shell forms, at least partially, the target inner wall of the cranial orthosis. In such an embodiment, the inner cavity of the outer shell does not represent the inner cavity of the cranial orthosis, since it is not adapted to contain the user's head.In other modalities, the first inner shell may form the first reduced inner wall of the cranial orthosis, the second inner shell may form the second reduced, more voluminous inner wall of the cranial orthosis, and the target inner wall of the cranial orthosis may be formed by the inner wall of the cranial orthosis. The cranial remodeling orthosis assembly of this modality comprises an outer shell and at least two inner shells, these inner shells being adapted to define, when connected to the outer shell, different internal cavities of the cranial orthosis, corresponding to different phases of head growth in the user. Petition 870260058976, dated 06 / 17 / 2026, page 16 / 47 12 / 38 023 Preferably, the inner shell comprises a perforated inner shell surface. The inner shell surface may be rigid or flexible, with greater flexibility being achieved through perforations or material selection. Preferably, the inner shell further comprises a three-dimensional mesh structure that at least partially fills the volume between the insert surface and the inner wall of the cranial orthosis. The inner shell comprises an inner shell surface, wherein the inner shell surface may be continuous or perforated. The inner shell may be implemented only as a specifically shaped wall that defines the insert surface, which is adapted for removable connection to the outer shell on its circumference.In other embodiments, the inner shell may comprise a three-dimensional mesh structure that at least partially fills the space between the surface of the inner shell and the inner wall of the cranial orthosis that is covered by the inner shell, wherein the three-dimensional mesh structure may also form the surface of the inner shell. 024 The 3D mesh structure comprises molded openings distributed throughout its volume, the specific implementation of which can be used to modify the flexibility or stiffness of the inner shell, or just a part of it. Depending on the specific shape, distance, and size, the openings modify the stiffness of the given region and give it a different directional expansion. The openings must be volume cutouts of a specific shape in the volume of the 3D mesh structure. The stiffness of the 3D mesh structure is determined by the specific shape, distance, and size of the openings located in the given volume. The openings are distributed throughout the volume of the 3D mesh structure in such a way that the rigid structure filling the volume between them has the structure of a three-dimensional (3D) mesh.In cases where the openings are smaller, have a shape that provides greater rigidity to the surrounding structure, and / or are far apart from each other, thicker structures of the material filling the space between the openings are obtained, thus ensuring greater rigidity of the 3D mesh structure. 3D printed structures more... Petition 870260058976, dated 06 / 17 / 2026, page 17 / 47 13 / 38 Thick structures are understood as structures with a larger cross-section in the space between the openings and with a greater volumetric representation in proportion to the volumetric representation of the openings. If the openings have a larger shape that provides less rigidity to the surrounding structure and / or are located close to each other, weaker structures are obtained from the material that fills the space between the openings, thus ensuring less rigidity of the 3D mesh structure. Weaker 3D printed structures are understood as structures with a smaller cross-section in the space between the openings and with less volumetric representation in relation to the volumetric representation of the openings. 025 Cranial remodeling orthoses, in various internal and external lining modalities, form the target inner wall, which defines the target cavity of the cranial orthosis, and the reduced inner wall, which defines the reduced cavity of the cranial orthosis. The target cavity and the reduced cavity of the cranial orthosis can also be understood, in the context of the invention, as cavities defined not only by the cranial remodeling orthosis, but also by the external shape of the user's head, specifically the initial shape of the user's head. In other words, in general, the inner cavity of the cranial orthosis can be understood as the cavity between the external shape of the user's head and the inner wall of the cranial orthosis.Thus, the target internal cavity of the cranial orthosis can be understood as the cavity between the initial external shape of the user's head and the target internal wall of the cranial orthosis, and the reduced internal cavity of the cranial orthosis can be understood as the cavity between the initial external shape of the user's head and the reduced internal wall of the cranial orthosis. In this sense, the reduced internal cavity of the cranial orthosis can be 10 to 90% smaller, preferably 40 to 60% smaller, than the target internal cavity of the cranial orthosis. 026 The inner shell of the invention is preferably adapted to be placed in the inner cavity of the shell. Petition 870260058976, dated 06 / 17 / 2026, page 18 / 47 14 / 38 external part of the cranial orthosis, in a region corresponding to an area of ​​significant deformation in the user's head, that is, a region where the current shape of the user's head is significantly smaller than the normal physiological shape of the target head for treatment with the cranial remodeling orthosis, where growth should be supported by the orthosis in that location, while in other regions of the head growth can be limited by the orthosis. Thus, the inner wall of the inner shell corresponds to the shape of the head at a certain intermediate stage between the current shape of the head and the target physiological shape of the head. 027 In order for the product of the design and production method of the cranial remodeling orthosis, according to the invention, to function properly, it is necessary that the reduced inner wall correspond, at least partially, to the target inner wall of the cranial orthosis when centered. The difference in its shape is necessary only at the site of the deformation, where the reduced inner wall reduces, at least partially, the space between the user's head and the target inner wall of the cranial orthosis. The inner shell must form the reduced inner wall in such a way that it corresponds to the intermediate stage of head growth at the site of the deformation, while in other regions of the head it is undesirable to support growth, since they have a shape that already corresponds to the target external shape of the head, and in these other regions (which are not part of the deformation) the inner wall of the cranial orthosis remains unchanged in both the reduced and target versions. 028 Preferably, the inner shell is connected to the outer shell in at least two different locations, distributed around the circumference of the inner shell. Preferably, the inner shell is connected to the inner wall of the cranial orthosis along most 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 circumference, and preferably the connection to the outer shell is located around the Petition 870260058976, dated 06 / 17 / 2026, page 19 / 47 15 / 38 circumference of the inner shell to ensure the most stable possible adhesion of the inner shell to the inner face of the outer shell, thus avoiding the formation of gaps between the shells at the margins. Similarly, in embodiments where the inner shell is connected to the outer shell in other regions of the outer shell, such as around its circumference at the orifice of the inner cavity of the outer shell or from the outer face of the outer shell, it is preferable, even here, that the connections be located around the circumference or margin of the inner shell. Thus, the connections are not located where the inner shell and / or the outer shell form the inner wall of the cranial orthosis, not structurally affecting the structure of the shells in these locations, and the structure of the inner wall of the cranial orthosis can be entirely focused on the function and comfort of the cranial remodeling orthosis. 029 Preferably, the inner shell is made of 3D printed material. The inner and outer shells are preferably manufactured using 3D printing technology such as SLA, SLS, FDM, MJF, DLP, 3DP, PJF, and CLIP. The material for producing the inner and / or outer shell can be, for example, polymers such as PA, ABS, PLA, PE, PP, CPP, HPP, PC, PETG, photopolymers, elastomers (TPU, TPA, TPE, silicones), and other suitable materials not only for the 3D printing methods mentioned above. Preferably, a thermoplastic elastomer, such as thermoplastic polyamide (TPA), thermoplastic polyurethane (TPU), or a copolymer blend (TPE), is used to produce the three-dimensional mesh structure. 030 The initial step in the design and production method of the cranial remodeling orthosis of the invention is obtaining a model of the initial external shape of the user's head, or a three-dimensional model based on the actual anatomical shape of the user's head. This model can be obtained in various ways, from various scanning methods to the input of the measured data into a computational device that projects the three-dimensional model of the head based on this data. The user refers to Petition 870260058976, dated 06 / 17 / 2026, page 20 / 47 16 / 38 person for whom the cranial remodeling orthosis is intended. The most common method for obtaining the three-dimensional model based on the anatomical shape of the user's head is a direct three-dimensional scan of the user's head. During the 3D scan, the data obtained from the 3D scan of the user's head is transformed into a polygonal grid of defining points with a density of at least 10 points per cm2. Another method is to make a physical model of the user's head, for example, from a mold of the user's head, and a subsequent 3D scan of the created physical model. In some cases, it is advisable to modify the physical model of the head before the 3D scan.Other methods for obtaining the initial external shape model of the user's head include, for example, scanning the internal area of ​​an existing cranial orthosis or making a physical model of the user's head from an existing cranial orthosis and subsequently scanning the external area of ​​the resulting physical head model, which may be modified before scanning. Additionally, the initial external shape model of the user's head can be obtained by initially measuring the user's head, for example, its circumference, width, length, and diagonal dimensions. This data is entered into a computer device based on the information entered by the user, which designs a 3D model based on this data. The resulting 3D model, based on the anatomical shape of the user's head, is then uploaded from the scanning device to the computer device, where it is further processed within the design method according to the invention. 031 The next stage is the design of the cranial orthosis model, which includes the steps of determining the target external shape of the user's head, determining the target internal wall of the cranial orthosis, determining the reduced internal wall of the cranial orthosis, and designing the internal shell. The step of determining the target external shape of the user's head is performed based on the input parameters that make up the initial external shape model of the user's head. Petition 870260058976, dated 06 / 17 / 2026, page 21 / 47 17 / 38 The initial external shape model of the user's head can be modified before further measures are taken to better suit the user's specific needs. Thus, the initial external shape model of the user's head can mean a physical representation, a modified physical representation, a digital representation, or a modified digital representation of the user's external head shape. Other input parameters may represent age, gender, type and severity of deformity, user's medical data, planned length for cranial orthosis treatment, head width at various locations, head length, head circumference, percentage of head shape / circumference growth, diagonal head dimensions, or other parameters representing the initial state of the user's head.Thus, the input parameters define the user's initial state; in particular, the data that define the current deformation and affect the head reshaping process are important. 032 The target external head shape is designed based on these input parameters, being based on the shape the head should have, that is, the physiological shape of the head, taking into account the planned period of use of the cranial remodeling orthosis by the user. The user's initial head shape, or the model of the user's initial external head shape, shows the regions and types of deformities that need to be corrected. The most common corrections are a defect in head symmetry - plagiocephaly, a defect in head proportions - brachycephaly, or a combination of a defect in symmetry and a defect in proportions - the so-called combined deformity.In the centralized position of the 3D model of the user's initial external head shape and the 3D model of the target external head shape, in some regions the 3D model of the target external head shape is located above the area of ​​the 3D model of the user's initial head shape, where in these regions head growth will be supported; in other regions, the area of ​​the 3D model of the target external head shape merges with the area of ​​the 3D model of the initial external shape. Petition 870260058976, dated 06 / 17 / 2026, page 22 / 47 18 / 38 user's head, where in these regions growth will be at least partially limited. 033 The step of determining the target inner wall of the cranial orthosis is based on the step of determining the target external shape of the user's head, where the resulting shape of the target inner wall is determined to achieve the target external shape of the user's head. In some modalities, the shape of the target inner wall of the cranial orthosis may directly correspond to the target external shape of the user's head. In other modalities, their shapes may differ; for example, the target inner wall of the cranial orthosis may be smaller in some regions or may represent a less voluminous head shape, where in these reduced regions the target inner wall of the cranial orthosis comprises flexible regions that can provide a firmer and more stable fit of the orthosis on the head, while at the same time, thanks to the flexibility, these regions support the growth of the head to a certain extent. 034 The design phase of the cranial orthosis model also includes the design phase of the outer shell. It is designed to form a sufficient structural base for the specific implementation of the inner walls of the cranial orthosis. In modalities where the inner wall of the outer shell forms the target inner wall of the cranial orthosis, it is evaluated whether additional layers, such as a lining, will be implemented in the outer shell. These layers and additional elements in the internal cavity of the orthosis affect the shape of the internal cavity of the cranial orthosis for insertion into the user's head, whether target or reduced, and therefore affect its function as a reshaping tool. All this information must be processed to create a customized lining and shell that, together, form the ideal inner wall of the cranial orthosis, which will be comfortable and represent the ideal reshaping tool to achieve a physiological head shape.Thus, in some modalities, the outer shell or its surface may correspond to the shape of the target inner wall of the cranial orthosis, plus an additional thickness. Petition 870260058976, dated 06 / 17 / 2026, page 23 / 47 19 / 38 corresponding to the additional layer provided, as a coating, so that, together, they form a shape corresponding to the target inner wall of the cranial orthosis. In other words, the inner wall of the outer shell does not need to correspond to the shape of the target inner wall of the cranial orthosis, since the resulting shape of the target inner wall of the cranial orthosis is obtained by placing the additional layer over the inner wall of the outer shell. In modalities without additional layers, the shape of the inner wall of the outer shell may directly correspond to the target outer shape of the user's head. 035 Next, the design phase of the cranial orthosis model comprises the step of determining the reduced inner wall of the cranial orthosis. The step of determining the reduced inner wall of the cranial orthosis occurs similarly to the step of determining the target inner wall of the cranial orthosis, except that it is not based on the target external shape of the user's head, but on the shape of a certain intermediate stage of growth between the initial external shape of the user's head and the target external shape of the user's head. Thus, it can be said that the reduced inner wall of the cranial orthosis is designed based on a reduced model of the initial external shape of the user's head that corresponds to this intermediate stage of growth. Therefore, the step of determining the reduced inner wall of the cranial orthosis comprises the step of comparing the model of the initial external shape of the user's head with a representation of the target external shape of the user's head.The representation of the user's target external head shape can, in various modalities, signify the user's target external head shape, the target internal wall of the cranial orthosis, and the target internal cavity of the cranial orthosis, in digital or physical format. In some modalities, the cranial remodeling orthosis with the target internal wall of the cranial orthosis can be formed before the conception and production of the inner shell; in these cases, the representation of the user's target external head shape may already be this formed target internal wall of the cranial orthosis. In such modalities, for example... Petition 870260058976, dated 06 / 17 / 2026, page 24 / 47 20 / 38 For example, the appropriate reduced inner wall of the cranial orthosis, or inner shell, can be determined by a trial-and-error method using pre-produced inner shells, where the best fit is tested in the comparison step. The step of determining the reduced inner wall of the cranial orthosis and the step of designing and producing the inner shell can therefore occur simultaneously or can be completely merged into a single step. Preferably, however, this comparison step occurs in a digitized format, where the models are centered and the step of determining the reduced inner wall of the cranial orthosis occurs based on the space between the area of ​​the 3D digital model of the initial shape of the user's head and the representation of the 3D digital model of the target external shape of the user's head. 036 In some modalities, the shape of the reduced inner wall of the cranial orthosis may directly correspond to the reduced external shape of the user's head. In other modalities, their shapes may differ; for example, the reduced inner wall of the cranial orthosis may be smaller in some regions or may represent a less voluminous head shape, and in these reduced regions, the reduced inner wall of the cranial orthosis includes flexible regions that can provide a firmer and more stable fit of the orthosis on the head, while at the same time, thanks to the flexibility, these regions support the growth of the head to a certain extent. 037 In the step of determining the reduced inner wall of the cranial orthosis, the shape of the reduced inner wall of the cranial orthosis can be projected by averaging the area of ​​the model of the initial external shape of the user's head with the area of ​​the representation of the target external shape of the user's head, and thus, the 3D model of the reduced inner wall of the cranial orthosis is formed by points corresponding to the average of these coordinates of these two areas that represent the initial and target shapes of the user's head. In other modalities, the reduced inner wall can be projected so that it is not entirely halfway between these areas, as in the case Petition 870260058976, dated 06 / 17 / 2026, page 25 / 47 21 / 38 of the average, but closer to the area that forms the initial external shape model of the user's head or the target external shape model area of ​​the user's head, preferably located 1 / 3 to 2 / 3 of the distance between the initial model area and the target model area of ​​the user's head. More preferably, the reduced inner wall shape of the cranial orthosis is located 1 / 3 to 1 / 2 of the distance between the initial model area and the target model area of ​​the user's head.In specific dimensions, the largest gap between the model of the user's initial external head shape and the representation of the user's target head shape at the deformation site often reaches a distance of 10 to 25 mm. The reduced inner wall of the cranial orthosis may be 3.33 mm to 5 mm away in the corresponding region in the case of a 10 mm gap, and 8.33 mm to 12.5 mm in the case of a 25 mm gap between the model of the user's initial external head shape and the representation of the user's target head shape at the deformation site. In other regions, the distances between the model of the user's initial external head shape and the representation of the user's target head shape decrease towards the region of greatest deformation, and, according to the given ratio, the distances relative to the reduced inner wall of the cranial orthosis decrease accordingly. 038 The methods of designing the reduced inner wall of the cranial orthosis presented in the previous paragraph are adapted to support uniform growth in all regions of deformation where head symmetry, and possibly also head proportions, are corrected by growth in the target inner wall of the cranial orthosis. In other preferred embodiments, for combined defects of symmetry and proportion of the user's head, the reduced inner wall of the cranial orthosis can be designed to correspond to the external shape of the user's head with corrected symmetry, where the inner shell and the reduced inner cavity formed by the cranial orthosis first resolve head symmetry and then, after removal of the inner shell, head growth in the inner cavity. Petition 870260058976, dated 06 / 17 / 2026, page 26 / 47 22 / 38 target of the cranial orthosis resolves the head proportion. In other modalities, first the head proportions and then the head symmetry can be resolved analogously. 039 The inner shell design stage is based on the outer shell design stage and the stage of determining the reduced inner wall of the cranial orthosis and / or the stage of determining the target inner wall of the cranial orthosis. As part of the inner shell design, the implementation of the respective outer shell for which the inner shell was designed is evaluated. In the inner shell design stage, it is evaluated whether additional layers will be implemented in the inner shell, such as a lining. These layers and additional elements in the internal cavity of the orthosis affect the shape of the internal cavity of the cranial orthosis for insertion into the user's head, whether target or reduced, and therefore affect its function as a remodeling tool.All this information must be processed to create a customized liner and shell that, together, form the ideal inner wall of the cranial orthosis, which will be comfortable and represent the ideal reshaping tool to achieve a healthy head shape. Thus, in some modalities, the inner shell or its surface may correspond to the shape of the reduced inner wall of the cranial orthosis, plus a thickness corresponding to the additional layer provided, as a lining, so that together they form a shape corresponding to the reduced inner wall of the cranial orthosis. In other words, the surface of the inner shell does not need to correspond to the shape of the reduced inner wall of the cranial orthosis, the resulting shape of the reduced inner wall of the cranial orthosis being obtained by applying an additional layer over the surface of the inner shell.In models without additional layers, the shape of the inner shell surface can directly correspond to the reduced outer shape of the user's head. 040 In embodiments where the inner shell is connected to the inner wall of the outer shell that forms the target inner wall of Petition 870260058976, dated 06 / 17 / 2026, page 27 / 47 23 / 38 cranial orthosis, the structure of the inner shell is adapted to this wall so that, after connection, the surface of the outer shell continuously follows the surface of the inner wall of the outer shell, while, at the same time, the surface of the outer shell corresponds to the corresponding reduced inner wall of the cranial orthosis. 041 In embodiments where the cranial remodeling orthosis of the invention is part of an assembly with at least two replaceable inner shells, these inner shells are designed so that both shells can be removablely connected to an outer shell of the cranial orthosis. One of these replaceable inner shells may be designed based on the reduced shape of the inner wall of the cranial orthosis, and the other replaceable inner shell may be designed based on the target shape of the inner wall of the cranial orthosis. Thus, in these embodiments, the inner shell design step comprises a design of at least two inner shells based on the step of determining the reduced inner wall of the cranial orthosis and the step of determining the target inner wall of the cranial orthosis. 042 Preferably, in the design phase of the inner shell, the inner shell is designed so that it is located exclusively in the space between the target inner wall of the cranial orthosis and the model of the initial external shape of the user's head. Inner shells preferably serve primarily to reduce the space between the target inner wall of the cranial orthosis and the model of the initial external shape of the user's head, where, in other regions, they would cause unnecessary pressure on the user. In this way, the inner shell can also be designed and produced in addition to already formed cranial orthoses that already form the target inner wall of the cranial orthosis. 043 Preferably, in the comparison stage, a digitized 3D model of the initial external shape of the user's head and a digitized 3D model of the target internal wall of the cranial orthosis are Petition 870260058976, dated 06 / 17 / 2026, page 28 / 47 24 / 38 compared. In this way, it is possible to easily compare these models and design the reduced inner wall of the cranial orthosis more accurately, without major deviations. 044 Preferably, the method for designing and producing the cranial remodeling orthosis comprises the step of obtaining the input parameters, the input parameter being the model of the initial external shape of the user's head and at least one parameter from the following set: age, gender, type and severity of the deformity, planned length for treatment with the cranial orthosis, head width, head length, head circumference, percentile of head circumference growth, and diagonal dimensions of the head. In the design step of the cranial remodeling orthosis model, the cranial remodeling orthosis model is designed based on the input parameters. Age determines, among other things, the size of the head, its physiological shape, and the rate of head growth.This data can be used to improve the accuracy of the internal wall models of the cranial orthosis, where the head growth rate determines when it will grow to both the reduced and target shapes, allowing for precise timing of the remodeling process and follow-ups with the specialist. The planned treatment duration, especially in combination with the growth rate, forms the data on which the specific implementation of the internal walls of the cranial orthosis is based. The percentile of head circumference growth is data that determines the head growth curve over time, which, in turn, is data to which the specific implementation of the internal walls of the cranial orthosis can be adapted.The type and severity of the deformity can also serve to improve the accuracy of the cranial orthosis model, which can therefore be reflected in specific implementations of the inner walls of the cranial orthosis, specifically through the implementation of the lining, flexible regions and / or distances between the inner walls of the cranial orthosis and the user's head in the regions of the deformity. Petition 870260058976, dated 06 / 17 / 2026, page 29 / 47 25 / 38 045 Preferably, the production stage of the inner shell is carried out using a 3D printing method. The 3D printing method enables the production of the inner shell of the invention with minimal initial cost. 046 Preferably, in the step of determining the reduced inner wall of the cranial orthosis, the reduced inner wall of the cranial orthosis is determined so that the volume between the model of the initial external shape of the user's head and the reduced inner wall of the cranial orthosis is 10 to 90% smaller than the volume between the model of the initial external shape of the user's head and the target inner wall of the cranial orthosis. More preferably, the volume between the model of the initial external shape of the user's head and the reduced inner wall of the cranial orthosis is 40 to 60% smaller than the volume between the model of the initial external shape of the user's head and the target inner wall of the cranial orthosis. DESCRIPTION OF THE DRAWINGS 047 A summary of the invention is further clarified by means of examples of its embodiment, described with reference to the accompanying drawings, in which: 048 Figure 1 shows a lateral section of the cranial remodeling orthosis. 049 Figure 2 shows a top section of the cranial remodeling orthosis according to the first embodiment example. 050 Figure 3 is a perspective illustration of the cranial remodeling orthosis according to the first embodiment example with an opening for manipulation and a perforated surface of the inner concha. 051 Figure 4 is a perspective illustration of the cranial remodeling orthosis according to the first embodiment example with an alternative implementation of the inner shell with the perforated surface of the inner shell without the opening for manipulation. Petition 870260058976, dated 06 / 17 / 2026, page 30 / 47 26 / 38 052 Figure 5 is a perspective illustration of the cranial remodeling orthosis according to the first embodiment example with an alternative implementation of the inner shell without the perforated surface of the inner shell. Figure 6 shows a lateral section of the cranial remodeling orthosis according to the second embodiment example. Embodiment example. 054 Figure 7 shows a top section of the cranial remodeling orthosis according to the second embodiment example. 055 Figure 8 is a perspective illustration of the cranial remodeling orthosis according to the second embodiment example. 056 Figure 9 shows a lateral section of the cranial remodeling orthosis according to the third embodiment example. 057 Figure 10 shows a top section of the cranial remodeling orthosis according to the third embodiment example. 058 Figure 11 is a perspective illustration of the cranial remodeling orthosis according to the third embodiment example. 059 Figure 12 shows a lateral section of the cranial remodeling orthosis according to the fourth embodiment example. 060 Figure 13 shows a top section of the cranial remodeling orthosis according to the fourth embodiment example. 061 Figure 14 is a perspective illustration of the cranial remodeling orthosis according to the fourth embodiment example. 062 Figure 15 shows a lateral section of the cranial remodeling orthosis according to the Fifth Exemplary Modality. 063 Figure 16 shows a top section of the cranial remodeling orthosis according to the fifth exemplary modality. 064 Figure 17 is a perspective illustration of the cranial remodeling orthosis according to the fifth exemplary modality. Petition 870260058976, dated 06 / 17 / 2026, page 31 / 47 27 / 38 065 Figure 18 shows a lateral section of the cranial remodeling orthosis according to the sixth exemplary modality. 066 Figure 19 shows a top section of the cranial remodeling orthosis according to the sixth exemplary modality. 067 Figure 20 shows a lateral section of the cranial remodeling orthosis according to the seventh exemplary modality. 068 Figure 21 shows a top section of the cranial remodeling orthosis according to the seventh exemplary embodiment. 069 Figure 22 is a perspective illustration of the cranial remodeling orthosis according to the seventh exemplary embodiment. 070 Figure 23 shows a lateral section of the cranial remodeling orthosis according to the eighth exemplary embodiment, with the inner shell defining the reduced internal cavity of the cranial orthosis. 071 Figure 24 shows a top section of the cranial remodeling orthosis according to the eighth exemplary embodiment, with the inner shell defining the reduced internal cavity of the cranial orthosis. 072 Figure 25 shows a lateral section of the cranial remodeling orthosis according to the eighth exemplary embodiment, with the inner shell defining the target internal cavity of the cranial orthosis. 073 Figure 26 shows a top section of the cranial remodeling orthosis according to the eighth exemplary embodiment, with the inner shell defining the target internal cavity of the cranial orthosis. Petition 870260058976, dated 06 / 17 / 2026, pp. 32 / 47 28 / 38 074 Figure 27 shows a lateral section of the cranial remodeling orthosis, with the outer shell defining the target internal cavity of the cranial orthosis without the inner shell. 075 Figure 28 shows a top section of the cranial remodeling orthosis, with the outer shell defining the target internal cavity of the cranial orthosis without the inner shell. 076 Figure 29 shows a diagram of the centered model of the initial external shape of the user's head, the model of the reduced external shape of the user's head, and the model of the target external shape of the user's head. EXAMPLES OF IMPROVEMENT OF THE INVENTION 077 The method of designing and producing the cranial remodeling orthosis of the invention will be better clarified by means of embodiments and resulting products, with reference to the respective drawings. 078 The first exemplary embodiment of the method for designing and producing the cranial remodeling orthosis of the invention and its arrangement are illustrated in Figures 1, 2 and 3. The cranial orthosis of the first exemplary embodiment comprises an outer shell 1 comprising an inner wall 2 of the outer shell that defines an inner cavity of the cranial orthosis, wherein both the outer and inner shells 1 and 4 are made of a 3D printed material, in particular polyamide. The inner wall 2 of the outer shell represents, herein, the target inner wall 10 of the cranial orthosis, the target cavity of the cranial orthosis corresponding to the inner cavity 3 of the outer shell. The inner shell 4 is fixed to the inner wall 2 of the outer shell by gluing.On the surface 6 of the inner shell and in the adjacent regions of the inner wall 2 of the outer shell, a lining 13 is placed, in which the lining 13 and the inner shell 4, together, reduce the volume of the inner cavity 3 of the outer shell to the reduced inner cavity 5 of the cranial orthosis. The inner shell 4 defines a space that reduces the target inner cavity 11 of the cranial orthosis. Petition 870260058976, dated 06 / 17 / 2026, pp. 33 / 47 29 / 38 Cranial orthosis (internal cavity 3 of the external shell), the reduced internal wall 12 resulting from the cranial orthosis being represented by the surface of the lining 13. In the design of the internal shell 4, the thickness of the lining 13 was considered such that, when the lining 13 is inserted, together they form the reduced internal wall 12 resulting from the cranial orthosis. The internal shell 4 comprises the perforated surface 6 of the internal shell, including a handling opening 14 on the surface 6 of the internal shell that serves to facilitate the removal of the internal shell 4 from the external shell 1. The cranial orthosis of the first example is composed of two pieces, comprising a front part (left in Figure 1) and a rear part of the shell (right in Figure 1), which together form the external shell 1.The inner wall 2 of the outer shell on the front is provided with lining 13, and the inner wall 2 of the outer shell on the front and the corresponding lining 13 together partially form the target and reduced inner walls 10 and 12 of the cranial orthosis. Thus, in this embodiment of the product, the difference between the target and reduced inner walls 10 and 12 of the cranial orthosis is formed only by the inner shell 4 and the lining 13 on the back of the cranial orthosis. 079 The inner wall 2 of the outer shell of the backpiece can also have its shape adapted for the placement of the sheath 13, so that, together, they can form the target inner wall 10 of the cranial orthosis in the backpiece of the outer shell 1. In such an embodiment, the sheath 13 illustrated in Figures 1 and 2 can, after the removal of the inner shell 4, simultaneously form the sheath 13 which, together with the inner wall 2 of the outer shell of the backpiece, forms the target inner wall 10 of the cranial orthosis. 080 In a model 8 of the initial external shape of the head illustrated in Figure 2, it can be observed that the head presents a significant deformation in the right rear part (upper left corner in Figure 2), which decreases towards the left rear side of the head (upper right corner in Figure 2), and, on the left rear side of the head, Petition 870260058976, dated 06 / 17 / 2026, pp. 34 / 47 30 / 38 presents a near-physiological target shape. As can be seen in Figure 2, the reduced internal cavity 5 is designed based on the user's external head shape, with corrected symmetry. The difference between the reduced internal wall 12 and the target internal wall 10 of the cranial orthosis lies only in the length of the head, where the target internal wall 10 is slightly lower, with its left and right sides symmetrical, as can be seen in the upper section of Figure 2. After achieving a head shape close to the shape of the reduced internal wall 12 of the cranial orthosis, a near-corrected symmetry of the head is expected. Consequently, the target internal wall 10 is then adapted to correct the proportions of the head. 081 In an alternative embodiment of the cranial orthosis of the first exemplary embodiment of the product, the target inner wall 10 of the cranial orthosis, or the inner wall 2 of the outer shell, may be designed to be adapted to receive the sheath 13, which is inserted into the cavity after removal of the inner shell 4. In such an embodiment, the inner wall 2 of the outer shell is larger in a dimension corresponding to the additional layer provided, such as the sheath 13, so that when this layer is inserted together, they form the resulting target inner wall 10 of the cranial orthosis. 082 In an alternative embodiment of the cranial orthosis of the first exemplary embodiment of the product, the inner shell 4 does not comprise the handling opening 14 on the surface 6 of the inner shell. This embodiment is illustrated in Figure 4. 083 In an alternative embodiment of the cranial orthosis of the first exemplary embodiment of the product illustrated in Figure 5, the inner shell 4 does not comprise the perforated surface 6 of the inner shell. 084 The cranial orthosis of the second exemplary modality is illustrated in Figures 6 to 8. This modality differs from the first exemplary modality in that the inner shell 4 is connected to the outer shell 1 by means of the covering 13 that the outer shell Petition 870260058976, dated 06 / 17 / 2026, pp. 35 / 47 31 / 38 has an application point for the inner shell 4. The inner shell 4 is connected to the sheath 13 by double-sided adhesive tape. Thus, the target inner wall 10 of the cranial orthosis in this embodiment means the sheath surface 13 on the inner face of the outer shell, and the reduced inner wall 12 of the cranial orthosis is formed by the surface 6 of the inner shell and the sheath surface 13 on the inner wall 2 of the outer shell that is not covered by the inner shell 4. 085 The cranial orthosis of the third exemplary modality is illustrated in Figures 9 to 11. This modality differs from the first exemplary modality in that the reduced inner wall 12 of the cranial orthosis corresponds to a direct intermediate stage of growth between the initial external shape of the user's head and the target external shape 9 of the user's head. Thus, the area of ​​the reduced inner wall 12 of the cranial orthosis corresponds to the average between the area of ​​the model 8 of the initial external shape of the user's head and the area of ​​the model representing the target external shape 9 of the user's head. Thus, the reduced inner wall 12 of the cranial orthosis, or the reduced model 8 of the initial external shape of the user, corresponds to a head shape that presents both signs of asymmetry and defects in proportion, and both symmetry and proportions are corrected only by the target inner wall 10 of the cranial orthosis. 086 The cranial orthosis of the fourth exemplary modality is illustrated in Figures 12 to 14. This modality differs from the third exemplary modality by comprising a larger inner shell 4, in which the difference between the reduced inner cavity 5 and the target inner cavity 11 is greater than in the third exemplary modality. The surface 6 of the inner shell of the fourth exemplary modality more continuously follows the inner wall of the cranial orthosis, and the use of the cranial orthosis is therefore more comfortable, since the reduced inner wall 12 of the cranial orthosis corresponds better to the actual shape of the user's head. In this Petition 870260058976, dated 06 / 17 / 2026, pp. 36 / 47 32 / 38 mode, the inner shell 4 is connected to the inner wall 2 of the outer shell with double-sided adhesive tape. 087 The cranial orthosis of the sixth exemplary modality is illustrated in Figures 15 to 17. In this modality, the cranial remodeling orthosis is adapted to correct a deformation in the frontal part of the head. The inner shell 4 is connected to the inner wall 2 of the outer shell of the frontal piece. 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, being made of a 3D-printed thermoplastic elastomer. 088 The cranial orthosis of the sixth exemplary modality is illustrated in Figures 18 to 19. This modality differs from the first exemplary modality in that the inner shell 4 comprises a 3D mesh 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, and is therefore elastic, further increasing the flexibility of the reduced inner wall 12 of the cranial orthosis that comes into contact with the user's head, making the cranial orthosis more comfortable. 089 The cranial orthosis of the seventh exemplary embodiment is illustrated in Figures 20 to 22. This cranial remodeling orthosis is particularly characterized by being part of an arrangement of a cranial remodeling orthosis comprising two different inner shells 4. Figure 20 shows a section of the cranial remodeling orthosis of the seventh exemplary embodiment with the first inner shell 4 defining the reduced internal cavity 5 of the cranial orthosis. The first inner shell 4 is connected to the outer shell 1 along its circumference by a groove-projection type mechanical connection, where the inner shell 4 is made by 3D printing from a thermoplastic elastomer, where its shape defines both the groove and the projection at the connection point. The outer shell 1 at this point also defines both the groove and the projection with its shape. Petition 870260058976, dated 06 / 17 / 2026, pp. 37 / 47 33 / 38 corresponding to both the groove and the projection of the inner shell 4. The first inner shell 4 comprises the perforated surface 6 of the inner shell and the 3D mesh structure 7 following the surface 6 of the inner shell, which fills the space between the surface 6 of the inner shell and the inner wall of the cranial orthosis. In this embodiment, both the 3D mesh structure 7 and the surface 6 of the inner shell are formed by an elastic thermoplastic elastomer, where the entire inner shell 4 represents a flexible region that deforms elastically when a force acts on the surface 6 of the inner shell. In other embodiments, the 3D mesh structure 7 is formed by a more rigid material, forming a support for the surface 6 of the inner shell.Model 8 of the initial external shape of the user's head illustrated in Figures 20 and 21 is the reduced external shape of the user's head, where this model 8 corresponds to the reduced internal wall 12 of the cranial orthosis, thus illustrating model 8 of the head at the moment when the head has grown into the reduced internal cavity 5 of the cranial orthosis and is approximately the moment of replacing the first internal shell 4 with the second internal shell 4, which defines the target internal cavity 11 of the cranial orthosis. 090 The cranial orthosis of the eighth exemplary embodiment is illustrated in Figures 23 to 26. Like the seventh exemplary embodiment of the product, the eighth embodiment is characterized by being part of a cranial remodeling orthosis assembly comprising the first inner shell 4 which defines the reduced inner wall 12 of the cranial orthosis and the second inner shell 4 which defines the target inner wall 10 of the cranial orthosis. Both inner shells 4 are adapted for the placement of the sheath 13 on their surface, forming the inner wall of the cranial orthosis together with this sheath 13. The cranial orthosis of the eighth exemplary modality with the first inner shell 4 is illustrated in Figures 23 and 24. The first inner shell 4 is formed by a superficial wall of the inner shell 4 that defines the surface 6 of the inner shell and that is adjacent, along its circumference, to a corresponding area. Petition 870260058976, dated 06 / 17 / 2026, pp. 38 / 47 34 / 38 formed by the structure of the outer shell 1, with these areas of the inner and outer shells 4 and 1 being connected by means of double-sided adhesive tape. In an alternative embodiment, they are mechanically connected by a pin and groove connection. The surface of the first inner shell 4 is adapted with its shape to form the reduced inner wall 12 of the cranial orthosis, together with the sheath 13. The cranial orthosis of the eighth exemplary embodiment with the second inner shell 4 is illustrated in Figures 25 and 26. The second inner shell 4 is structurally identical to the first inner shell 4, except that it differs in the shape of the surface of the second inner shell 4. This is because the surface of the second inner shell 4 is adapted with its shape to form the target inner wall 10 of the cranial orthosis, together with the sheath 13. 091 All drawings of the eighth product modality (Figures 23 to 26) also show model 8 of the initial external shape of the user's head, where it can be observed how the first and second inner shells 4 alter the size of the space between the initial external shape of the user's head and the defined inner wall of the cranial orthosis. 092 The method of designing and producing the cranial remodeling orthosis of the invention will be described here using specific embodiments. 093 In an exemplary embodiment of the method of designing and producing the cranial remodeling orthosis of the invention, in the step of obtaining model 8 of the initial external shape of the user's head, the user's head is scanned by a scanning device, where the created 3D scan is stored in the memory of a computer device. This 3D scan of the user's head represents model 8 of the initial external shape of the user's head. The description of the relationship between the individual scanned areas (model 8 of the external shape of the user's head, areas corresponding to the internal walls of the cranial orthosis, ...) is related to their centralized position in relation to model 8 of the initial external shape of the Petition 870260058976, dated 06 / 17 / 2026, pp. 39 / 47 35 / 38 user's head. A schematic example of the centering of these areas is illustrated in Figure 29. 094 The input parameters also include the information that the target inner wall 10 of the cranial orthosis should be provided with a 5 mm coating 13 and the information that correction of head symmetry is preferred, followed by correction of head proportions. Based on this model 8 of the initial external shape of the user's head, the target external shape 9 of the user's head is subsequently designed, and then modified for the final implementation of the target inner wall 10 of the cranial orthosis. Now, the shape of the target inner wall 10 of the cranial orthosis is known, and the design of the outer layer 1 in the computer device follows so that the cranial orthosis in the result has the target shape of the inner wall of the cranial orthosis.The 3 mm thick lining 13 will be placed on the inner wall of the cranial orthosis. The inner wall 2 of the outer shell, which together with lining 13 should define the target inner cavity 11 of the cranial orthosis, is therefore increased by 3 mm over the area that defines the target inner cavity 11 of the cranial orthosis, where the difference between the area that defines the target inner cavity 11 of the cranial orthosis and the area that defines the inner wall 2 of the outer shell corresponds to the dimensions of lining 13. Thus, lining 13 placed on the inner wall of the cranial orthosis reduces the inner cavity 3 of the outer shell to a cavity corresponding to the target inner cavity 11 of the cranial orthosis. Thus, it is now possible to design the entire inner shell 4, which is structurally designed from the determined shape of the inner wall 2 of the outer shell, in order to give the cranial orthosis sufficient firmness and structural stability.Subsequently, the outer shell 1 is produced using the 3D printing method. 095 The external shell 1 produced, defining the target internal cavity 11 of the cranial orthosis, is illustrated in Figures 27 and 28, where a significant gap is observed between model 8 of the initial external shape of the user's head and the target internal wall 10 of the cranial orthosis, resulting in Petition 870260058976, dated 06 / 17 / 2026, pp. 40 / 47 36 / 38 unwanted rotations of the cranial orthosis around the user's head. Therefore, the inner shell 4 is subsequently designed to reduce this volume, based on the reduced external shape of the user's head or the reduced inner wall 12 of the cranial orthosis. 096 The next step is to determine the reduced internal wall 12 of the cranial orthosis, schematically illustrated in Figure 29. This step involves comparing the model 8 of the user's initial external head shape with the representation of the target external head shape 9. The initial external head shape is first compared with the target external head shape 9. In Figure 29, it can be observed that the user's head presents a significant deformation in the right posterior region, a deformation that disturbs the overall symmetry and proportions of the head. The reduced internal wall 12 of the cranial orthosis should correspond to the corrected symmetry of the head, and subsequently, the proportion defect will be corrected by the growth of the head in the target internal cavity 11 of the cranial orthosis.In this embodiment, the reduced inner wall 12 of the cranial orthosis is formed by modifying the target inner wall 10 of the cranial orthosis, which is modified by its displacement towards the model of the initial external shape of the user's head, maintaining a symmetrical shape. The reduced inner wall 12 of the cranial orthosis is designed here to divide the volume between the area corresponding to the initial external shape of the user's head and the area corresponding to the target external shape 9 of the user's head into two approximately equal cavities (see Figure 29). 097 The design step for the inner shell 4 based on the reduced inner wall 12 of the cranial orthosis is as follows. The inner shell 4 will not be provided with a lining 13 or any other complementary layer, and the surface 6 of the inner shell should correspond as closely as possible to the surface of the reduced inner wall 12 of the orthosis. Petition 870260058976, dated 06 / 17 / 2026, pp. 41 / 47 37 / 38 cranial. Thus, the inner shell 4 is designed in such a way that its surface corresponds completely to the reduced inner wall 12 of the cranial orthosis at the point where it differs from the target inner wall 10 of the cranial orthosis; at the points where they overlap, the reduced inner wall 12 of the cranial orthosis is formed by the lining 13 on the inner wall 2 of the outer shell. The inner shell 4 is adapted for connection to the outer shell 1 by means of its lining 13, comprising a contact area around its circumference that corresponds to the lining 13 of the outer shell 1 at the indicated point, both being connected by double-sided adhesive tape. 098 Subsequently, the designed inner shell 4 is produced by 3D printing and connected to the outer shell 1 on the front of the lining 13 with double-sided adhesive tape, thus completing the production stage of the cranial orthosis. 099 The product resulting from the exemplary method of design and production, according to the invention, is a cranial orthosis according to the second exemplary embodiment illustrated in Figures 6 to 8. 0100 In the example of the design and production method above, it can be observed that the design and production stage of the outer shell 1 and the design and production stage of the inner shell 4 can occur separately at different times. In an alternative embodiment, the inner shell 4 can be designed first, and subsequently, a suitable outer shell 1 can be designed for it. This may be preferable, for example, in the design and production methods of the cranial orthosis of the seventh and eighth modalities, which are part of the assembly of the cranial orthosis with two inner shells 4. In these, based on the reduced inner walls and determined targets 12 and 10 of the cranial orthosis, it is necessary to design the first and second inner shells 4 adapted for the same removable connection with the outer shell 1. Then, the outer shell 1 can be Petition 870260058976, dated 06 / 17 / 2026, pp. 42 / 47 38 / 38 designed to represent the remainder of the cranial orthosis structure, providing structural stability and firmness to the cranial orthosis. INDUSTRIAL APPLICABILITY 0101 The invention can be used in the field of orthotic remodeling. 0102 List of Reference Signs: - Outer shell; - Inner wall of the outer shell; - Internal cavity of the outer shell; - Inner shell; - Reduced internal cavity of the cranial orthosis; - Surface of the inner shell; - 3D mesh structure; - Model of the initial external shape of the head; - Target external shape of the head; - Target inner wall of the cranial orthosis; - Internal cavity targeted by the cranial orthosis; - Reduced inner wall of the cranial orthosis; - Coating; - Handling opening. Petition 870260058976, dated 06 / 17 / 2026, pp. 43 / 47

Claims

1 / 4 CLAIMS 1. METHOD OF DESIGNING AND PRODUCING A CRANIAL REMODELING ORTHOSIS is characterized by comprising the steps of: a) obtaining a model (8) of an initial external shape of the user's head, b) designing a model of the cranial remodeling orthosis based on the model (8) of the initial external shape of the user's head, comprising a step of determining a target external shape (9) of the user's head based on the model (8) of the initial external shape of the user's head and a subsequent step of determining a target internal wall (10) of the cranial orthosis, defining a target internal cavity (11) of the cranial orthosis, wherein the shape of the target internal wall (10) is determined to achieve the target external shape (9) of the user's head, c) producing the cranial orthosis,wherein: the step of designing the cranial orthosis model b) further includes a step of determining a reduced internal wall (12) of the cranial orthosis defining a reduced internal cavity (5) of the cranial orthosis including a step of comparing the model (8) of the initial external shape of the user's head with a representation of the target external shape (9) of the user's head, wherein the step of designing the cranial orthosis model b) further includes a step of designing an internal shell (4) based on the step of determining the reduced internal wall (12) of the cranial orthosis, wherein the reduced internal wall (12) of the cranial orthosis is at least partially formed by the internal shell (4), wherein the reduced internal wall (12) of the cranial orthosis corresponds to a certain intermediate stage of growth between the initial external shape of the user's head and the target external shape (9) of the user's head,wherein the step of designing the cranial orthosis model b) further comprises a step of designing an outer shell (1), wherein the target inner wall (10) of the cranial orthosis is formed entirely by the outer shell (1), and the step of producing the cranial orthosis c) comprises a step of producing the inner shell (4) and a step of producing the outer shell (1). Petition 870250061225, dated 17 / 07 / 2025, pp. 101 / 122 2 / 4, 2. METHOD OF DESIGNING AND PRODUCING A CRANIAL REMODELING ORTHOSIS is characterized by comprising the steps of: a) obtaining a model (8) of an initial external shape of the user's head, b) designing a model of the cranial remodeling orthosis based on the model (8) of the initial external shape of the user's head, comprising a step of determining a target external shape (9) of the user's head based on the model (8) of the initial external shape of the user's head and a subsequent step of determining a target internal wall (10) of the cranial orthosis, defining a target internal cavity (11) of the cranial orthosis, wherein the shape of the target internal wall (10) is determined to achieve the target external shape (9) of the user's head, c) producing the cranial orthosis,wherein: the step of designing the cranial orthosis model b) further includes a step of determining a reduced internal wall (12) of the cranial orthosis defining a reduced internal cavity (5) of the cranial orthosis including a step of comparing the model (8) of the initial external shape of the user's head with a representation of the target external shape (9) of the user's head, wherein the step of designing the cranial orthosis model b) further includes a step of designing a first internal shell (4) based on the step of determining the reduced internal wall (12) of the cranial orthosis, wherein the reduced internal wall (12) of the cranial orthosis is at least partially formed by the first internal shell (4), wherein the reduced internal wall (12) of the cranial orthosis corresponds to a certain intermediate stage of growth between the initial external shape of the user's head and the target external shape (9) of the user's head,wherein the cranial orthosis model design step b) further comprises a step of designing a second inner shell (4) based on the target inner wall determination step (10), wherein the target inner wall (10) of the cranial orthosis is at least partially formed by the second inner shell (4), wherein the cranial orthosis model design step b) further comprises a step of designing an outer shell (1), wherein the first inner shell (4) and the second inner shell (4) are designed to be removablely connected to the outer shell (1) and to be mutually interchangeable, and the cranial orthosis production step c) comprises a production step of the first inner shell (4), a production step of the second inner shell (4) and a production step of the outer shell (1).

3. METHOD OF DESIGNING AND PRODUCING A CRANIAL REMODELING ORTHOSIS is characterized by, according to claim 1, the fact that in the design stage of the inner shell (4), the inner shell (4) is designed so that it is located exclusively in the space between the target inner wall (10) of the cranial orthosis and the model (8) of the initial external shape of the user's head.

4. METHOD OF DESIGNING AND PRODUCING A CRANIAL REMODELING ORTHOSIS is characterized by, according to claims 1 to 3, the fact that, in the comparison step, a digitized 3D model (8) of the initial external shape of the user's head and a digitized 3D model of the target internal wall (10) of the cranial orthosis are compared.

5. METHOD OF DESIGNING AND PRODUCING A CRANIAL REMODELING ORTHOSIS is characterized by, according to claims 1 to 4, comprising a step of obtaining input parameters, wherein the input parameter is the model (8) of the initial external shape of the user's head and at least one parameter from the following set: age, gender, type and severity of deformity, planned length of treatment with the cranial orthosis, head width, head length, head circumference, head circumference growth percentile, diagonal dimensions of the head, wherein, in the step of designing the cranial remodeling orthosis model, the cranial remodeling orthosis model is designed based on the input parameters.

6. METHOD OF DESIGNING AND PRODUCING A CRANIAL REMODELING ORTHOSIS is characterized by, according to claims 1 to 5, the fact that the design stage of the cranial remodeling orthosis model b) comprises a model modification stage (8) of the initial external shape of the user's head. Petition 870250061225, dated 17 / 07 / 2025, pp. 103 / 122 4 / 4 7. METHOD OF DESIGNING AND PRODUCING A CRANIAL REMODELING ORTHOSIS is characterized by, according to claims 1, 3, 4, 5 or 6, the fact that the production step of the inner shell (4) is carried out by a 3D printing method.

8. METHOD OF DESIGNING AND PRODUCING A CRANIAL REMODELING ORTHOSIS is characterized by, according to claims 1 to 7, the fact that in the step of determining the reduced inner wall (12) of the cranial orthosis, the reduced inner wall (12) of the cranial orthosis is determined in such a way that the volume between the model (8) of the initial external shape of the user's head and the reduced inner wall (12) of the cranial orthosis is 10 to 90% smaller than the volume between the model (8) of the initial external shape of the user's head and the target inner wall (10) of the cranial orthosis. Petition 870250061225, dated 07 / 17 / 2025, pp. 104 / 122

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