Cranial deformity correction device, system and method

Abstract

To provide a cranial deformity correction device for an infant's head, a manufacturing method and a manufacturing system thereof. The cranial deformity correction device 100 includes a rigid outer shell 110 having a front portion 111 removably connected to a rear portion 112. The front portion 111 is shaped and configured to be worn on the front of the baby's head. The rear portion 112 is shaped and configured to be worn on the back of the baby's head. The front portion 111 and the rear portion 112 may each have an inner surface including at least one lining target area and at least one lining-free area. The at least one lining target area includes a pad selectively positioned to inhibit head growth. The at least one lining-free area has a plurality of ventilation holes 114 extending through the inner surface to the outer surface and is selectively configured to allow head growth or displacement to correct the baby's head.

Description

Related Applications

[0001] This application claims the benefit of and priority to U.S. Provisional Patent Application No. 63 / 278,893, filed November 12, 2021, the entire teachings of which are incorporated herein by reference. [Technical field]

[0002] The present disclosure relates to an orthosis, and in particular to a cranial deformity correction orthosis for correcting the head shape of a young human being, such as, but not limited to, an infant or child (e.g., approximately 3 to 18 months of age). [Background technology]

[0003] During early infancy, the human skull is made up of plates of bone interconnected by ligaments known as sutures. As the infant grows, the plates fuse together, eventually forming the permanent skull shape. However, before the permanent skull shape is formed, the skull may be flexible or soft enough to deform under external pressure. For example, if a child's head is placed against a hard surface for an extended period of time, the child's skull may develop one or more flattened areas or regions.

[0004] In a sense, this process is thought of as flat-headed infantile syndrome, which may be present in a variety of ways, including but not limited to one or a combination of deformational plagiocephaly, brachycephaly, and navicular cephaly (also known as dolicocephaly). Babies may be fitted with skull correction helmets to encourage their skull to reshape into a common or other acceptable head shape. Typically, such helmets consist of a rigid shell with a foam lining on the inside that acts as a mold to encourage the specific shape into which the baby's skull will grow. Summary of the Invention [Problem to be solved by the invention]

[0005] Although traditional helmets have met with some success, the previous approach has certain shortcomings. For example, traditional helmets are labor intensive to manufacture and the use of compatible helmet materials is inadequate. Additionally, the previous approach requires multiple helmet adjustments to induce gradual skull correction, which unnecessarily increases the cost to helmet effectiveness. [Means for solving the problem]

[0006] The solution of the present disclosure overcomes the above-mentioned shortcomings and others that may become apparent in the future.

[0007] In one embodiment, a cranial deformity correction device is disclosed. The device may include a rigid outer shell having a front portion removably connected to a rear portion. The front portion is shaped and configured to be attached to the front of an infant's skull, and the rear portion is shaped and configured to be attached to the rear of the infant's skull. The front and rear portions may each have an inner surface including at least one lining target area and at least one lining-free area. The at least one lining target area includes a pad selectively positioned to inhibit cranial growth in an area of ​​the skull aligned below the lining target area, and the at least one lining-free area is configured to allow cranial growth in an area of ​​the skull aligned below the lining-free area, and the at least one lining-free area has a plurality of ventilation holes extending through the inner surface to an outer surface. In this regard, the at least one lining-free area may be configured to provide space above an area where cranial growth is desired.

[0008] In some configurations, the forward portion and the rearward portion each include a hollow gap between an inner surface and an outer surface.

[0009] In some configurations, the size and shape of each of the at least one lining target area is determined based on a precise 3D scan of the infant's skull, and the selectively placed pads are configured to inhibit further growth of a corresponding cranial region of the skull when the device is worn.

[0010] In some configurations, the size and shape of each of the at least one asymmetrical lining-free area is determined based on data from a precise 3D scan of the infant's skull.

[0011] In some configurations, the vents in the at least one asymmetrical unlined area are selectively arranged to terminate at a common inner circumference in a series of intersecting and / or spaced apart spiral curves or patterns. The diameter of the vents may vary gradually from a maximum diameter near or at the outer edge of the front and / or rear portions to a minimum diameter as the common inner circumference is approached. In some configurations, vents are arranged across the outer surfaces of the front and rear portions, extending toward the outer edge and terminating in a solid portion across the edge of the helmet. Vents are arranged in unlined areas of the inner surfaces of the front and rear shells, terminating in the lined area and / or the solid portion across the edge of the brace. Advantageously, the vents can cool and ventilate the child's or infant's head to allow for proper head growth.

[0012] In some configurations, when coupled, an annular opening is formed between adjacent upper contour edges of the forward and rearward portions.

[0013] In some configurations, a slit is formed between adjacent side edges of the front and rear portions when in a coupled state.

[0014] In some configurations, the forward portion and the rearward portion each have a pair of side edges extending from an upper profile edge to a lower profile edge, and at least one connection means integrally formed on each side edge, each connection means of the forward portion configured to securely connect with a corresponding connection means of the rearward portion.

[0015] In some configurations, the at least one connection means on each side edge of the forward portion is a tongue projecting orthogonally from each side edge.

[0016] In some configurations, the at least one connection means on each side edge of the rear portion is a receiving groove formed in each side edge, the receiving groove configured to securely receive a corresponding tongue of the forward portion in a shear-proof manner.

[0017] In some configurations, a locking mechanism is configured to move between a coupled state in which the front and rear portions are coupled and an uncoupled state in which the front and rear portions are disengaged. The locking mechanism may include a peripheral protrusion extending from an outer surface of the front and rear portions and surrounding an internal portion, and a clasp configured to securely engage a locking portion of the internal portion in the coupled state and to pivot away from the locking portion in the uncoupled state.

[0018] In one embodiment, a method for manufacturing a custom cranial deformity correction device for an infant's skull is disclosed, which includes the steps of: generating a 3D model of the infant's skull based on a 3D scan of the infant's skull using a 3D scanner; analyzing the 3D model using a computing device to determine at least one prominent part of the skull that needs to be corrected using the cranial deformity correction device; generating a corrected symmetrical shape model of the infant's skull based on the determined at least one prominent part; and processing the corrected symmetrical shape model sent from the computing device by an additive manufacturing device. and creating anterior and posterior portions of the outer shell of the custom cranial deformity correction brace based on the information from the data processor, the anterior and posterior portions each having an inner surface including at least one lining target area and at least one lining-free area, the at least one lining-free area being configured to allow for cranial growth of an area of ​​the skull aligned below the lining-free area, the at least one lining-free area having a plurality of ventilation holes extending through the inner surface to the outer surface, the plurality of ventilation holes being open to allow air to easily reach the skull without obstruction.

[0019] In some configurations, the method may include selectively positioning padding along at least one lining target area of ​​the posterior portion and / or the anterior portion to inhibit cranial growth of at least one prominent portion of the infant's skull when the customized cranial deformity correction device is worn.

[0020] In some configurations, the process of analyzing the three-dimensional model by the computing device to determine at least one prominent area of ​​the head that requires correction with the cranial deformity correction device includes a sub-step of applying a machine learning system to the three-dimensional model to identify at least one prominent area and determine a deformation treatment procedure associated with the corrected symmetrical shape model, the machine learning system having been generated by processing patient data and multiple past infant head training models.

[0021] In some configurations, the step of generating the corrected symmetric shape model of the infant's skull based on the at least one distinguishing region determined by the computing device includes a substep of superimposing at least one lining-free area and at least one padding area of ​​the anterior and posterior portions to correct the infant's skull. In this regard, the method may include the steps of detecting, by the computing device and the three-dimensional model, a cranial shape condition of the infant, including at least one of symmetric or asymmetric brachycephaly, plagiocephaly, and symmetric or asymmetric scaphocephaly, and determining, by the computing device, a padding arrangement for correcting the infant's skull to a shape corresponding to the corrected symmetric shape model based on the detected cranial shape condition.

[0022] In some configurations, the method may include the forward and aft portions of the outer skin shell being unitary.

[0023] In some configurations, the additive manufacturing apparatus of the present disclosure may be at least one of a powder bed fusion, binder jetting, material jetting, material extrusion, liquid bath photopolymerization, a laser-based stereolithography (SLA) system, a continuous liquid interface manufacturing (CLIP) system, a fused filament fabrication (FFF) system, a selective laser sintering (SLS) system, and a selective heat sintering (SHS) system.

[0024] In some configurations, the method may include selectively arranging the ventilation holes in the at least one unlined area to terminate at a common inner circumference in a series of intersecting and / or spaced spiral curves or patterns, wherein the diameter of the ventilation holes gradually changes from a maximum diameter near or toward the outer edge of the forward and / or rearward portions to a minimum diameter as the ventilation holes approach the common inner circumference.

[0025] In some configurations, a system for manufacturing a customized cranial deformity correction device includes at least one memory storing instructions and at least one processor, the at least one processor executing the instructions to perform the following steps: generating a three-dimensional model of the infant's skull based on a three-dimensional scan of the infant's skull; analyzing the three-dimensional model to determine at least one prominent region of the skull that requires correction with the cranial deformity correction device; generating a corrected symmetrical shape model of the infant's skull based on the determined at least one distinctive feature; and having an additive manufacturing device create anterior and posterior portions of an outer shell of the custom cranial deformity correction orthosis based on information of the corrected symmetrical shape model, the anterior and posterior portions each having an inner surface with at least one lining target area and at least one lining-free area, the at least one lining-free area having a plurality of ventilation holes extending through the inner surface to an outer surface; The device is configured to perform a process that may include:

[0026] To the accomplishment of the foregoing and related ends, certain illustrative configurations are described herein in connection with the following description and the annexed drawings. These configurations are indicative, however, of but a few of the various ways in which the principles of the claimed subject matter can take place and the claimed subject matter is intended to include all such configurations and equivalents. Other advantages and novel features may become apparent from the following detailed description when considered in conjunction with the drawings.

[0027] The above and further features of the present invention are described in detail with reference to the following description in conjunction with the accompanying drawings. In the various figures, like reference numerals refer to like structural elements and features. The drawings are not necessarily to scale, emphasis instead being placed upon illustrating the principles of the invention. The drawings depict at least one embodiment of an apparatus of the present invention, which are presented by way of example only and are not intended to be limiting. [Brief description of the drawings]

[0028] [Figure 1A] FIG. 1 is a top view of an example of an infant's head illustrating protruding and flattened areas that may require addressing with an orthotic. [Figure 1B] FIG. 1B is a side view of the example head of FIG. 1A showing protruding and flat areas that need to be addressed with an orthotic. [Diagram 2] FIG. 1 is a perspective view of a cranial reshaping orthosis according to some configurations of the present disclosure. [Figure 3A] FIG. 1 is a schematic plan view of an example of an asymmetric head of an infant wearing an orthotic according to some configurations of the present disclosure. [Figure 3B] 3B is a schematic plan view of an example of the head of the infant of FIG. 3A after being corrected to a symmetrical state by wearing the orthotic of FIG. 3A according to some configurations of the present disclosure. FIG. [Figure 4A] FIG. 1 is a perspective view of a posterior portion of an outer shell of an example cranial reshaping orthosis in accordance with some configurations of the present disclosure. [Figure 4B] FIG. 1 is a perspective view of a front portion of an outer shell of a cranial reshaping orthosis according to some configurations of the present disclosure; [Figure 5A] FIG. 1 is a perspective view of a posterior portion of a cranial deformity correction brace including an example of selectively placed padding, in accordance with some configurations of the present disclosure. [Figure 5B] FIG. 1 is a perspective view of a front portion of a cranial deformity correction brace including an example of selectively placed padding, in accordance with some configurations of the present disclosure. [Figure 6] 4B is a cross-sectional front view of the rear portion of FIG. 4A according to some configurations of the present disclosure. [Figure 7A] FIG. 1 is a side perspective view of a cranial deformity correction brace including an example of a fixing mechanism according to a portion of the present disclosure. [Figure 7B] FIG. 13 is a side perspective view of a cranial deformity correction brace with another example of a fixing mechanism according to some configurations of the present disclosure. [Figure 8A] 7B, showing an enlarged view of portion 8A of FIG. 7B, illustrating an example fastening mechanism in a coupled state according to some configurations of the present disclosure. [Figure 8B] 7B, showing an enlarged view of portion 8A of FIG. 7B, illustrating an example uncoupled clasp locking mechanism in accordance with some configurations of the present disclosure. [Figure 9] 1A-1C are schematic diagrams of corresponding stages of a system for stereolithography of multiple cranial deformity correctors for correcting a skull. [Figure 10] FIG. 1 is a computer architecture diagram illustrating a computing system capable of implementing configurations of the present disclosure in accordance with one or more embodiments described herein. [Figure 11A] FIG. 13 is a plan view of an example of a pad area of ​​a cranial deformity correction brace with pads placed overlying an infant C in whom symmetric brachycephaly has been detected. [Figure 11B] FIG. 11B is a front view of the example padded area of ​​FIG. 11A superimposed on an infant. [Figure 11C] FIG. 11B is a rear view of the example padded area of ​​FIG. 11A superimposed on an infant. [Figure 11D] FIG. 11B is a side view of the example padded area of ​​FIG. 11A superimposed on an infant. [Figure 12A]FIG. 13 is a plan view of an example of a pad area of ​​a cranial deformity correction brace with pads placed over one another on an infant C who has been found to have both brachycephaly and plagiocephaly. [Figure 12B] FIG. 12B is a front view of the example padded area of ​​FIG. 12A superimposed on an infant. [Figure 12C] FIG. 12B is a rear view of the example padded area of ​​FIG. 12A superimposed on an infant. [Figure 12D] FIG. 12B is a side view of the example padded area of ​​FIG. 12A superimposed on an infant. [Figure 13A] This is a plan view of an example of a pad area of ​​a cranial deformity correction brace with pads placed over each other on infant C in whom symmetric and asymmetric scaphocephaly has been detected. [Figure 13B] FIG. 13B is a front view of the example padded area of ​​FIG. 13A superimposed on an infant. [Figure 13C] FIG. 13B is a rear view of the example padded area of ​​FIG. 13A superimposed on an infant. [Figure 13D] FIG. 13B is a side view of the example padded area of ​​FIG. 13A superimposed on an infant. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0029] Although exemplary embodiments of the disclosed technology are described in detail herein, it is to be understood that other embodiments are possible, and that the disclosed technology is not limited in scope to the details of construction and the arrangement of components set forth in the following description or illustrated in the drawings, and that the disclosed technology is capable of other embodiments and of being practiced or carried out in various ways.

[0030] It should also be noted that, as used in this specification and the appended claims, the singular forms "a," "an," and "the" are intended to encompass plurals unless the context clearly dictates otherwise. "Comprising," "including," and "having" mean, at a minimum, that the subject compound, component, particle, or method process / step / step is present in a composition, article, or method, and do not exclude the presence of other compounds, substances, particles, method processes / steps / steps even if such other compounds, substances, particles, method processes / steps / steps have the same function as the subject compound.

[0031] Specific embodiments will be described in detail below with reference to the drawings. Similar reference numbers (e.g., 100 and 100', 111 and 111', etc.) refer to components of the same or similar functions. In describing the exemplary embodiments, terminology will be relied upon for brevity. Each term is intended to have the broadest meaning understood by those skilled in the art and encompasses all technical equivalents that perform similar functions to achieve similar purposes. Furthermore, when one or more steps / processes / procedures of a method are described, it should be understood that this does not exclude the existence of additional or intervening steps / processes / procedures of the method between the steps / processes / procedures specified. The steps / processes / procedures of the method may be performed in a different order than described herein without departing from the scope of the technology of the present disclosure. Similarly, when one or more components of an apparatus or system are described, it should be understood that this does not exclude the existence of additional or intervening components between the components specified.

[0032] The skull or head of a "subject" as referred to herein may refer to the skull or head of a young child, such as an infant.

[0033] As used herein, a "practitioner" may include, but is not limited to, a doctor, surgeon, nurse, physical therapist, or other medical professional, or any other suitable individual or delivery equipment associated with the device of the present disclosure.

[0034] In this specification, relative terms such as "about," "approximately," and "to the extent of" are used to indicate that the numerical values ​​stated may vary by ±10%.

[0035] In describing the exemplary embodiments, for the sake of brevity, we will rely on technical terms. Each term is intended to have the broadest meaning understood by those skilled in the art and is intended to encompass all technical equivalents that perform the same function and achieve the same purpose. It should also be understood that the description of one or more steps / processes / procedures of a method does not preclude the presence of additional or intervening steps / processes / procedures of the method between the steps / processes / procedures specified. The steps / processes / procedures of the method may be performed in a different order than described herein without departing from the scope of the technology of the present disclosure. It should also be understood that the description of one or more components of a device or system does not preclude the presence of additional or intervening components between the components specified.

[0036] As mentioned above, positional plagiocephaly is a condition in which parts of an infant's head (e.g., the back, left, or right side of the head) become flattened. Typically, this is the result of the infant being placed on their back or resting their head against a flat surface (e.g., a stroller, car seat, crib, playpen, etc.) for an extended period of time in a way that causes flattening. An infant's head is relatively soft and able to remodel to allow for brain growth during the first year of life. Unfortunately, infants are susceptible to being "molded" into a flat shape.

[0037] For illustrative purposes only, Figures 1A and 1B are plan and side views of an example of the head of infant C. Examples of protruding portion A and flattened portion B are depicted, and it can be seen that there is a certain degree of unevenness. As can be particularly seen from the gap depicted between the example of the overlapping line showing symmetry and the flattened portion B, the head of infant C depicted in Figures 1A and 1B requires cranial correction using a cranial deformity correction device to work toward approximating the shape corresponding to the example of the overlapping line showing symmetry.

[0038] FIG. 2 is a perspective view of a cranial deformity correction device 100 according to a part of the configuration of the present disclosure. The device 100 of the present disclosure is generally called a helmet, and is configured to eliminate head shape deformations such as plagiocephaly, brachycephaly, and navicular cephaly (for example, to correct asymmetric deformations, etc.). In some configurations, the device 100 is highly effective in eliminating head shape deformations in infants about 3 to 18 months old. The device 100 may be most suitable for use with younger infants (e.g., closer to 3 months old) because the growth rate decreases as the infant ages. The device 100 is configured to secure space over areas where head growth is desired while retaining or maintaining full contact with predetermined areas where head growth is undesirable. That is, the device 100 is designed to accommodate the natural growth of the baby's head while inhibiting the growth of convex areas (e.g., protruding areas, etc.) and allowing the growth of at least one identified prominent area (e.g., flat area B in FIGS. 1A and 1B) that requires correction by the device 100. In some configurations, the device 100 is configured to provide a symmetrical space for the baby's head to grow into when worn by the baby. The device 100 provides a cushioning that is tuned to prevent the baby's head from becoming more flattened even if the baby's head is placed on one side for a long period of time. In some configurations, the device 100 can include a rigid outer shell 110 (e.g., nylon 12 (polyamide 12), etc.) with at least one padded area 120 (e.g., a padded cushion formed of foam, etc.) selectively disposed along an inner surface of the shell 110.

[0039] In some configurations, at least one padding section 120 is positioned or aligned with a particular prominent portion of the head of the infant C (e.g., pressure points, protruding portions of the head of the infant C, etc.) to allow growth to occur in areas of the device 100 that would otherwise be unlined and provide void space. This eliminates excess material and weight from the device 100 and promotes breathability, thereby reducing sweating while wearing the device 100, as opposed to conventional helmet devices that completely cover the infant with padding or liners. In some configurations, foams contemplated for use in the at least one padding section 120 may include a closed cell ethylene vinyl acetate foam liner having a uniform density and / or hardness. However, other foam materials and variations in density and / or hardness are contemplated.

[0040] The shell 110 may be formed by two or more interconnected components. In some configurations, the two or more interconnected components of the shell 110 may be formed from additively laminated thermoplastic materials, such as, but not limited to, acrylonitrile butadiene styrene, nylon, polylactic acid, polyvinyl alcohol, polycarbonate, polystyrene, polyethylene terephthalate, and / or thermoplastic polyurethane. For example, the shell 110 may be formed by connecting a rear portion 112 (e.g., a front half portion) and a front portion 111 (e.g., a rear half portion). The portions 111 and 112 may be secured to each other by a fastening mechanism 130. In some configurations, the mechanism 130 may include a strap 132 extending from one portion (e.g., portion 112) to be securely attached to a corresponding receptacle (e.g., a receptacle provided on portion 111 in this example). The receptacle and the strap 132 may each include a hook-and-loop surface, such as provided by Velcro®. In other configurations, the mechanism 130 may include a latch 136 (e.g., a rivet, etc.) fixedly attached to one portion of the shell 110 (e.g., portion 112). The latch 136 may include a belt loop 134. A strap 132 extends from portion 112 and may be folded back into the belt loop 134 for attachment to the receptacle of portion 111. Of course, the illustrated configuration of the mechanism 130 is merely exemplary, and the components of the mechanism 130 may be modified or even interchanged (e.g., the strap 132 may extend from portion 111 to portion 112 rather than from portion 112 to portion 111 as shown and described). Additionally, instead of a single mechanism 130 as shown in FIG. 2, portions 111 and 112 may be secured together by multiple mechanisms 130 to securely engage portions 111 and 112 with one another.

[0041] In some configurations, the portions 111 and 112 of the shell 110 may each be selectively lined with a padded area 120. For example, the padded area 120 may be positioned only on the to-be-lined surfaces of the portions 111 and 112 to be aligned over the protruding areas (e.g., area A in FIGS. 1A and 1B) detected for the infant C, while the non-padded areas of the portions 111 and 112 may be positioned over or aligned over the flat areas (e.g., area B in FIGS. 1A and 1B). In some configurations, the inner surface of the shell 110 after the facade is created (e.g., after creation by method 900 described below) may include at least one area that is not lined for growth of the flat areas of the patient's head. The padded area 120 of the to-be-lined area is configured to correct the deformity by restricting undesired growth of the protruding areas while allowing desired growth at the flat areas. Padded area 120 also allows a practitioner to adjust the area underneath the interior surface of shell 110 to accommodate normal growth. In some configurations, if infant C's skull unexpectedly grows into a predetermined area (e.g., as a result of non-compliance on the part of infant C), the practitioner may be able to remove structure of padded area 120 accordingly (e.g., by selectively removing portions of padded area 120 or removing structure of padded area 120 entirely).

[0042] FIG. 3A is a schematic cross-sectional view of an example of an asymmetric head of an infant C wearing an example of the device 100. As shown, the padding area 120 is lined along the inner surface of the shell 110 and is placed in selective contact with a portion of the head of the infant C (e.g., a flattened portion and / or a protruding portion). The shape and contour of the inner surface of the shell 110 is essentially symmetrical and matches the symmetrical shape determined for the particular infant C. The portion of the padding area 120 that contacts the infant C prevents cranial growth. In contrast, the void area Z formed between the head of the infant C and the inner surface of the shell 110 allows cranial growth. FIG. 3B shows an example of an improved head of the infant C after the infant C wears the device 100 for a period of time (e.g., 3 months), in which the void area Z is mostly filled by the corrected symmetrical head of the infant C. FIG. 3B also shows that the growth of the rest of the head of the infant C has been prevented by the padding area 120.

[0043] FIG. 4A is a perspective view of an example of the rear portion 112. In some configurations, the portion 112 may include a lining target portion 115 that may be contoured to surround the appearance of the forehead of the head of the infant C. In some configurations, a portion or the entire inner surface of the portion 115 of FIG. 4A may include padding of the padded area 120. The portion 112 may further include a plurality of selectively positioned ventilation holes 114 aligned with the absence of lining of the portion 112. The portion or area of ​​the portion 112 that is absent of lining may be generally asymmetric. For example, the absence of lining of the portion 112 that includes the holes 114 may be provided on only one side of the portion 112. Also, the absence of lining of the portion 112 may be generally lacking in symmetry. In some configurations, the holes 114 may be arranged to terminate at a common inner circumference in a series of intersecting and / or spaced apart spiral curves or patterns that are not provided with lining.

[0044] In some configurations, holes 114 are incorporated into portions 112 only where there is no lining, i.e., no padding. In some configurations, holes 114 do not penetrate shell 110 in the lining areas where padding is to be applied (see, e.g., FIG. 6 ). In some configurations, the diameter of holes 114 may be the same. In some configurations, the shape and / or diameter of holes 114 may vary from a maximum near or toward the outer edge to a smaller diameter toward the inner portion of the non-lining portion of portions 112, 111. In some configurations, the diameter of holes 114 may vary in shape and diameter (e.g., from a larger outer shape like an oval (e.g., 12 mm×4 mm) to a smallest inner circle with a diameter of about 0.35 mm). Locating holes 114 only in the non-lined areas of shell 110 provides a solid, smooth surface on the inside of portions 111, 112 of shell 110 for attachment of padding in area 120. Locating holes 114 only in the non-lined areas also allows holes 114 to act as a pad placement guide (e.g., when padding area 120 is selectively positioned and / or when padding in area 120 is attached to the inside of shell 110). Portion 112 may have a solid contoured edge 119 that extends around the entire edge of portions 111, 112.

[0045] The portion 112 may have a plurality of connection means 116a integrally formed along the rear edge 106a. For example, one pair of connection means 116a may be located on the left side of the portion 112 and another pair of connection means 116a may be located on the opposite right side of the portion 112. In some configurations, each rear edge 106a with connection means 116a may extend longitudinally from a lower end adjacent the ear region of the infant C toward the top of the infant C's head. In some configurations, the portion 112 may have a solid upper contour edge 113a that may extend between upper corners of the edge 106a to form a semicircular shape.

[0046] FIG. 4B is a perspective view of an example of the front portion 111. In some configurations, like portion 112, portion 111 may include a lining target portion 115 that may be contoured to surround the rear appearance of the head of infant C. In some configurations, a portion or the entire inner surface of portion 115 of FIG. 4B may include padding of padded area 120. Also, like portion 112, portion 111 may further include a plurality of selectively positioned ventilation holes 114 aligned with the absence of lining in portion 111. These ventilation holes 114 may also be asymmetric in nature and appearance. In some configurations, holes 114 are incorporated only in portions of portion 111 where there is no lining, i.e., no padding. The portion 111 may have a plurality of connecting means 116b integrally formed along the leading edge 106b, the connecting means 116b being configured to securely engage with corresponding connecting means 116a of the portion 112.

[0047] For example, the connecting means 116a, 116b may be tongue (e.g., protrusions, etc.) and groove (e.g., recesses, etc.) connecting means configured to prevent shearing while maintaining a smooth transition between the portions 111, 112. FIG. 5A illustrates an example of the connecting means 116a protruding from each edge 106a, while the connecting means 116b in FIG. 5B comprises a recess in each edge 106b configured to form a friction fit with the corresponding connecting means 116a. In some configurations, a continuous contoured outer surface may be formed between the portions 111, 112 after the connecting means 116a, 116b are connected to each other. In some configurations, the portion 111 may have an upper contoured edge 113b that may extend between the upper corners of the edges 106b to form a semicircular shape. When portions 111 and 112 are coupled together in a coupled state, edges 113a and 113b may form an annular opening (e.g., a generally circular opening, etc.) on the upper surface of shell 110. In some configurations, the opening formed between edges 113a and 113b may expose the top of infant C's head after wearing by infant C, thereby allowing continued head growth within the allotted space. It can be seen that when portions 111 and 112 are coupled, shell 110 forms a generally lateral cleft therebetween.

[0048] FIG. 5A is a perspective view of portion 112 with example pads (e.g., pads 122, 125 of pad area 120, etc.) selectively placed along the lining absence on the inner surface of portion 112. By way of example only and not by way of limitation, pad 122 may be selectively placed on the underside of portion 112 adjacent to lining edge 119 based on a precise 3D scan of infant C's head and related analysis (see, e.g., method 900 of FIG. 9, etc.). Also, selective placement of the lining absence with hole 114 may be performed based on the precise 3D scan of infant C's head and related analysis. In some configurations, pad 122 may be configured to redirect the growth of infant C's head at a corresponding identified prominent portion of the head when device 100 is worn. Similarly, pad 125 may be placed on the inner surface opposite the lining absence. In some configurations, pad 125 may extend between the lining absences of hole 114, edge 113a, and edge 119. Like pad 122, pad 125 may be configured to provide a direct pressure point against infant C when device 100 is worn to inhibit further growth of the corresponding region of the infant's head.

[0049] 5B is a perspective view of portion 111 with example padding selectively positioned along the absence of lining on the inner surface of portion 111, such as pads 123, 125 of padding area 120. In some configurations, pad 123 may be positioned along a lower edge of portion 111 between the side edges and below the absence of lining at hole 114. Each of pads 123, 125 in FIG. 5B may provide a direct contact pressure point for infant C when device 100 is worn to inhibit further growth of the corresponding region of infant C's head.

[0050] 6 is a front cross-sectional view of the middle of portion 112 of FIG. 4A according to some configurations of the present disclosure. As shown, portion 112 may be hollow with gap 105 formed between inner surface 115d and outer surface 115c of lining target portion 115. In some configurations, the wall thickness of each wall of inner surface 115d and outer surface 115c may be on the order of 1.25 mm, and gap 105 may be on the order of 2 mm, resulting in a total thickness of portion 112 (and portion 111) of 4.5 mm. A similar gap may also be present between the inner and outer surfaces of the non-lining portion, including holes 114. The gap 105 is highly advantageous as it reduces the weight of device 100, thereby improving comfort for infant C wearing device 100.

[0051] FIG. 7A is a side perspective view of device 100 in a locked state with portions 111 and 112 locked together, including locking mechanism 130 as described above. Portions 111 and 112 are locked together in said coupled state with a smooth transition therebetween, as described above. FIG. 7B is a side perspective view of another example of device 100', including another example of locking mechanism 140 shown in portion 8A instead of and / or in addition to locking mechanism 130 as described above. FIG. 8A is a close-up view of portion 8A of FIG. 7B, showing the same example of locking mechanism 140 in a locked state. Mechanism 140 can be an integrated clasp mechanism.

[0052] The features 140 may be integrally formed with the portions 111', 112' and disposed on adjacent edges of a side slit that extends between the portions 111', 112' when the portions 111', 112' are coupled together. The features 140 may include a first peripheral protrusion 142a of the portion 111' and a second peripheral protrusion 142b of the portion 112'. The protrusions 142a, 142b may extend radially outward from the outer surfaces of the portions 111', 112', respectively. The protrusions 142a, 142b may each be partially elliptical or semicircular in shape such that when the portions 111', 112' are coupled together, the protrusions 142a, 142b form a corresponding peripheral shape (e.g., a peripheral ellipse, a peripheral circle, any suitable or desired shape, etc.). The mechanism 140 may further include a first internal portion 144a of the portion 111' and a second internal portion 144b of the portion 112'. The portions 144a, 144b may extend radially outward and be disposed within and / or nested with the corresponding protrusions 142a, 142b, respectively. The portions 144a, 144b may each be partially elliptical or semicircular in shape such that when the portions 111', 112' are coupled together, the portions 144a, 144b form a corresponding circumferential shape (e.g., a circumferential ellipse, a circumferential circle, or any other suitable or desired shape). In some configurations, the portion 144b may further include a stop 145 on an edge opposite the portion 144a. A clasp 143 may be pivotally connected to at least one edge of the portion 144a. The coupled state of Figure 8A shows that the catch 143 is held securely under the structure of the catch 145, which creates a smooth transition between the sections 111', 112'. In contrast, in the uncoupled state of Figure 8B, the catch 143 has been decoupled from the catch 145 by pivoting about a pivot in the middle of the section 144a (e.g., about a hinge therein). It can be seen that in the uncoupled state, a space has been created between the sections 111' and 112', and the smooth transition between them has disappeared.Of course, the example of Figures 7B to 8B is just one embodiment, and the parts may be interchanged or rearranged (for example, locking part 145 may be on part 144a, and clasp 143 may be rotatably connected to part 144b).

[0053] 9 illustrates an example method 900 for manufacturing a customized brace in accordance with some aspects of the present disclosure. In step 905, a digital, accurate, three-dimensional model of the head of infant C may be generated for infant C by scanning the head of infant C with a three-dimensional scanner 910. In step 907, the generated three-dimensional model is electronically transmitted to a computing device of a manufacturing device 1000, such as an additive manufacturing device 930, also known as a "stereolithography" system.

[0054] In step 909, the device 1000 may analyze (e.g., semi-automatically and / or fully automatically) the digital accurate three-dimensional model to determine at least one prominent area of ​​the head of the infant C that needs to be corrected by the orthotic. In some configurations, the computational techniques used to determine the at least one prominent area of ​​the head of the infant C may include, but are not limited to, statistical analysis, autonomous or machine learning, and AI. AI may include, but are not limited to, deep learning, neural networks, classification, clustering, and regression algorithms. By using such computational techniques, the accuracy of head diagnosis is significantly improved with reliability and efficiency. In some configurations, the computational system that processes one or more of the computational techniques described above may have a trained machine learning algorithm that takes the infant's head data, past infant head training models, and past patient data as inputs to determine at least one prominent area (e.g., protruding area, flat area, etc.) that needs to be corrected by a deformity correction device.

[0055] Learning what regions are salient can be done in a number of ways, including but not limited to: (1) Weakly supervised learning: training a machine learning system (e.g., multi-layer perceptron (MLP), convolutional neural network (CNN), graph neural network, support vector machine (SVM), random forest, etc.) by multiple instance learning (MIL) using digital images or sets of images with weak labels (labels can correspond to the presence or absence of salient features); and / or (2) bounding box or polygon-based supervised learning: training a machine learning system (e.g., Region-based CNN (R-CNN), Fast R-CNN, Selective Search, etc.) with bounding boxes or polygons that identify salient subregions of a digital image to detect the presence or absence of a biomarker; and / or (3) Pixel-level labeling (e.g., semantic segmentation, instance segmentation, etc.): training machine learning systems (e.g., Mask R-CNN, U-Net, fully convolutional neural networks, etc.) with pixel-level labeling that identifies individual pixels as salient; and / or (4) Use of other corresponding digital images to identify salient areas. The device 1000 may generate a symmetrical shape model of the head of the infant C after correction based on the determination of the at least one prominent part. For example, the model may include information related to the structure of the outer shell of the corresponding corrector (e.g., the dimensions and shapes of the rear part, the front part, the lining area, and the lining-free area, the position of the padding required for the correction of the head of the infant C, etc.). In some configurations, the machine learning system may be trained to detect the cranial shape state of the infant based on the three-dimensional model (e.g., at least one of symmetric brachycephaly, brachycephaly, plagiocephaly, and symmetric and asymmetric scaphocephaly, etc.). In some configurations, the machine learning system may also be trained to determine a pad arrangement configuration (e.g., see the arrangement configuration examples in Figures 11 to 13, which are not limiting of the present invention) for correcting the head of the infant to a shape corresponding to the symmetrical shape model after correction based on the detected cranial shape state. Rather than removing material from protruding areas of the head of the infant C, the flat areas of the head of the infant C may be corrected by adding padding to the at least one prominent area determined based on the generated model. Thus, in step 909, the device 1000 may generate a 3D model of the actual orthotic that is updated based on the corrected shape.

[0056] In step 911, a manufacturing device 930 fabricates at least one shell model based on the updated straightened symmetrical geometric model to form the front portion 111 and the rear portion 112 of the shell 110. In some configurations, the front portion 111 and the rear portion 112 of the shell 110 are a single integral unit or are integrally formed with each other.

[0057] In some configurations of the method 900, the fabricated orthotic shell 110 may be packaged as a kit with a padding kit corresponding to the dimensions of the helmet shell 110 and the desired correction for the head of the infant C. In some configurations, the packaged kit, which may include the corresponding padding and orthotic shell 110, may be shipped to a practitioner (e.g., a doctor, etc.) who fits the device to the head of the infant C.

[0058] In some configurations of method 900, the practitioner may selectively place padding material (e.g., foam pads, etc.) included in the padding kit only in the at least one determined region corresponding to a protruding portion of the child's head. Each pad has a pressure sensitive adhesive underside for application to the inside of the orthotic shell 110. Portions of the orthotic shell 110 may be perforated for ventilation (e.g., via holes 114), while other portions of the orthotic shell 110 may be relatively smooth along the inside surface (e.g., surface 115d, etc.) for optimal adhesion with the padding material. In some configurations, some or all of the padding material previously added to the at least one determined region may be removed (e.g., by scraping or removing the entire pad) to accommodate changes in the shape of the infant C's head as the infant C grows.

[0059] FIG. 10 is a general computer architecture diagram illustrating a computing system capable of implementing the disclosed arrangements in accordance with one or more embodiments described herein. The computer 1000 of the exemplary manufacturing method 900 illustrated in FIG. 9 may be configured to perform at least one function according to an embodiment of the present disclosure. For example, the computer 1000 may be configured to process 3D scan information of a particular child C's head to create an orthotic (e.g., device 100, 200, 300, 400, etc.) that is tailored to the precise scan of the infant C's head. It should be understood that the computer 1000 may be implemented in a single computing device or in a computing system formed of multiple connected computing devices. The computer 1000 may be configured to perform various distributed computing tasks, and processing and / or storage resources may be distributed among multiple devices. The data acquisition and display computer 1050 and / or the operation console 1010 of the system illustrated in FIG. 10 may be one or more systems or components of the computer 1000.

[0060] As shown, the computer 1000 includes a processing unit 1002 ("CPU"), a system memory 1004, and a system bus 1006 connecting the memory 1004 to the CPU 1002. The computer 1000 further includes a mass storage device 1012 for storing a program module 1014. The program module 1014 may be operable to analyze and / or modify the current settings of the applicator and / or to personalize the structure of the orthotic for the infant C, such as the structure of the outer shell and padding and their respective dimensions and positions. The program module 1014 may include an imaging application 1018 for performing the data acquisition and / or processing functions described herein to acquire and / or process image data corresponding to, for example, a three-dimensional scan of the head of the infant C. The computer 1000 may include a data store 1020 for storing data, which may comprise imaging-related data 1022, such as data acquired by performing a magnetic resonance imaging procedure according to embodiments of the present disclosure.

[0061] Mass storage device 1012 is connected to CPU 1002 through a mass storage controller (not shown) connected to bus 1006. Mass storage device 1012 and its associated computer storage media provide non-volatile storage for computer 1000. Although the discussion of computer storage media contained herein refers to mass storage devices such as hard disks and CD-ROM drives, those skilled in the art will recognize that any available computer storage media may be used as long as it is accessible by computer 1000.

[0062] By way of non-limiting example only, computer storage media (also referred to herein as "computer-readable storage media") may include volatile or non-volatile, removable or non-removable media implemented in any method or technology for storing information, such as computer stored instructions, data structures, program modules, and other data. Examples of computer storage media include, but are not limited to, solid-state memory technologies such as RAM, ROM, EPROM, EEPROM, Flash memory, optical storage devices such as CD-ROM, digital versatile disks ("DVD"), HD-DVD, BLU-RAY®, magnetic storage devices such as magnetic cassettes, magnetic tape, magnetic disk storage, or any other medium that can be utilized to store the desired information and that can be accessed by computer 1000. As used herein, "computer storage media" and "computer-readable storage media" do not include transient signals.

[0063] In various embodiments, computer 1000 may operate in a networked environment by connecting to other local or remote computers over network 1016 via network interface 1010 coupled to bus 1006. Network interface 1010 may couple input / output of the computing device to one or more suitable networks and / or connections, such as a local area network (LAN), a wide area network (WAN), the Internet, a cellular network, a radio frequency (RF) network, a Bluetooth®-enabled network, a Wi-Fi®-enabled network, a satellite-based network, or other wired and / or wireless network for communicating with external devices and / or systems.

[0064] The computer 1000 may further include an input / output controller 1008 that receives and processes input from any of a number of input devices, which may include one or more of a keyboard, a mouse, a stylus, a touch screen, a microphone, an audio capture device, and an image / video capture device. An end user may use the input devices to interact with a user interface, such as a graphical user interface, to manage the various functions performed by the computer 1000. The bus 1006 may enable code and / or data to be read from and / or read from the processing unit 1002 to a computer storage medium, such as a mass storage device 1012.

[0065] The computer storage medium may represent devices in the form of storage elements implemented in any suitable technology, including but not limited to semiconductors, magnetic materials, optical devices, etc. The computer storage medium may comprise memory components characterized as RAM, ROM, flash, etc. types of technology. The computer storage medium may also comprise secondary storage devices, such as hard drives. Hard drive implementations may be characterized as solid state or may include rotating media that store magnetically encoded information. Program modules 1014, including imaging application 1018, may include instructions that, when loaded and executed by processing unit 1002, provide computer 1000 with functionality in accordance with one or more embodiments illustrated in the figures of this disclosure. Program modules 1014 may also provide various tools and techniques for computer 1000 to participate in an overall system or operating environment utilizing components, flows, and data structures described throughout this specification.

[0066] In general, the processing unit 1002, or the entire computer 1000, which is a general-purpose computing system, may be converted into a special-purpose computing system by loading and executing the program module 1014 into the processing unit 1002. The processing unit 1002 may be constructed from any number of individual circuit elements, such as transistors, which may be individually or collectively in any number of states. More specifically, the processing unit 1002 may operate as a finite state machine in response to executable instructions contained within the program module 1014. These computer-executable instructions may specify transitions between states of the processing unit 1002, thereby causing changes in the individual hardware elements, such as transistors, that make up the processing unit 1002, causing the processing unit 1002 to change.

[0067] Also, the physical structure of the computer storage medium may be changed by encoding the program module 1014. The specific change in physical structure may depend on various factors in each embodiment of the present specification. Examples of such factors may include, but are not limited to, the technology used to realize the computer storage medium, such as whether the computer storage medium is characterized as a primary or secondary memory. For example, if the computer storage medium is realized as a semiconductor-based memory, the physical state of the semiconductor memory may be changed by encoding software into the program module 1014. For example, the program module 1014 may change the state of individual circuit elements, such as transistors, capacitors, etc., that make up the semiconductor memory.

[0068] As another example, the computer storage medium may be implemented using magnetic or optical technology. In such implementations, software may be encoded into the program module 1014 to change the physical state of the magnetic or optical media. Such changes may include changing the magnetic properties of a particular location within a given magnetic media. Also, such changes may include changing the optical properties of a particular location within a given optical media due to changes in the physical characteristics or properties of the location. Other changes of the physical media are possible without departing from the scope of this specification, and the above examples are merely provided to facilitate this description.

[0069] 11A-11D show examples of various cranial deformities with corresponding pad kits and selective placements. In particular, FIGS. 11A-11D are diagrams of examples of pad areas 220 of a cranial deformity correcting device 200 with pads superimposed on an infant C with detected symmetric brachycephaly. In some configurations, an embodiment of method 900 has been performed in which infant C has been determined to have symmetric brachycephaly based on a scan of infant C, and the structure of device 200 is created accordingly. In FIGS. 11A-11D, pad areas 220 of device 200 are selectively placed in a placement optimized for inhibiting further growth of corresponding regions of infant C's head. For example, the pad placement of area 220 corresponds to inhibiting further growth of the forehead region, suboccipital neck region, and occipital temporal region of infant C's head.

[0070] 12A-12D are diagrams of examples of pad areas 320 of a cranial deformity correction device 300 with pads positioned over an infant C in which asymmetric brachycephaly and / or brachycephaly and plagiocephaly have been detected. In some configurations, an embodiment of method 900 has been performed in which infant C is detected and determined to have asymmetric brachycephaly and / or brachycephaly and plagiocephaly based on a scan of infant C, and the structure of device 300 is created accordingly. In FIGS. 12A-12D, pad areas 320 of device 300 are selectively positioned in a position optimized to inhibit further growth of corresponding regions of infant C's head. For example, the pad positioning of area 320 corresponds to inhibiting further growth of the forehead region, suboccipital neck region, and occipital temporal region of infant C's head.

[0071] 13A-13D are diagrams of examples of pad areas 420 of a cranial deformity correction device 400 with pads superimposed on an infant C in which symmetric and asymmetric scaphocephaly have been detected. In some configurations, an embodiment of method 900 has been performed in which infant C is detected and determined to have symmetric and asymmetric scaphocephaly based on a scan of infant C, and the structure of device 400 is created accordingly. In FIGS. 12A-12D, pad areas 420 of device 400 are selectively positioned in a position optimized to inhibit further growth of corresponding regions of infant C's head. For example, the pad positioning of area 420 corresponds to inhibiting further growth of the forehead region, suboccipital neck region, and occipital temporal region of infant C's head.

[0072] The specific configuration, material selection, and dimensions and shapes of each component may be changed according to the specific design specifications and constraints required for the system or method constructed according to the principles of the technology of the present disclosure. Such changes are intended to be included within the scope of the technology of the present disclosure. In other words, the embodiments of the present disclosure are exemplary in all respects and should not be considered to limit the present invention. Thus, although specific forms of the present disclosure have been illustrated and described, various changes can be made without departing from the spirit and scope of the present disclosure, and it will be apparent from the above that all changes within the meaning and scope of the equivalent are included in the present disclosure.

Claims

1. A cranial deformity correction device for an infant's skull, comprising: a rigid outer shell having a front portion removably connected to a rear portion, the front portion being shaped and configured to be fitted to a front portion of the infant's skull and the rear portion being shaped and configured to be fitted to a rear portion of the infant's skull; Equipped with the anterior and posterior portions each have an interior surface including at least one lining target area and at least one lining-free area, the at least one lining target area having a pad selectively positioned to inhibit cranial growth in an area of ​​the skull aligned below the lining target area, and the at least one lining-free area is configured to permit cranial growth in an area of ​​the skull aligned below the lining-free area; The at least one lining-free area has a plurality of ventilation holes extending through the inner surface to the outer surface.

2. 10. The brace of claim 1, wherein the anterior and posterior portions are each hollow with a gap formed between an inner surface and an outer surface, and the at least one lining-free area is asymmetric.

3. 2. The brace of claim 1, wherein the size and shape of the at least one lining target area is determined based on a precise 3D scan of the infant's skull, and the selectively placed pads are configured to provide direct pressure points against the infant's skull to inhibit further growth of a corresponding cranial region thereof when the brace is worn.

4. 10. The brace of claim 1, wherein the size and shape of the at least one lining-free area is determined based on data from a precise 3D scan of the infant's skull.

5. 5. The brace of claim 4, wherein the vents in the at least one unlined area are selectively arranged to terminate at a common inner circumference in a series of intersecting and / or spaced apart spiral curves or patterns, and wherein the diameters of the vents vary gradually from a maximum diameter near or toward an outer edge of the anterior and / or posterior portions to a minimum diameter as the common inner circumference is approached.

6. The brace of claim 1 , wherein, in a connected condition, an annular opening is formed between adjacent upper contour edges of the anterior and posterior portions.

7. The brace of claim 1 , wherein in a connected state, a slit is formed between adjacent side edges of the front and rear portions.

8. 2. The brace of claim 1, wherein the anterior and posterior portions each have a pair of side edges extending from an upper profile edge to a lower profile edge and at least one connection means integral with each side edge, each connection means of the anterior portion configured to securely connect with a corresponding connection means of the posterior portion.

9. 9. The brace of claim 8, wherein said at least one connection means on each side edge of said anterior portion is a tongue projecting orthogonally from each side edge.

10. 10. The brace of claim 9, wherein the at least one connection means on each side edge of the rear portion is a receiving groove formed in each side edge, the receiving groove configured to positively receive a corresponding tongue of the front portion in an anti-shear manner.

11. The orthosis of claim 1, further comprising: a locking mechanism configured to move between a coupled state in which the front portion and the rear portion are coupled and a non-coupled state in which the front portion and the rear portion are disengaged; wherein the fixing mechanism includes a peripheral protrusion protruding from an outer surface of the anterior portion and the posterior portion and surrounding an internal portion, and a clasp configured to securely engage a locking portion of the internal portion in the connected state and to rotate away from the locking portion in the unconnected state.

12. A method for manufacturing a custom cranial deformity correction device for an infant's skull, comprising the steps of: generating a three-dimensional model of the infant's skull based on a three-dimensional scan of the infant's skull with a three-dimensional scanner; analyzing the three-dimensional model by a computing device to determine at least one prominent region of the skull that requires correction by the cranial deformity correction device; generating, by the computing device, a corrected symmetrical shape model of the infant's skull based on the determined at least one distinctive feature; fabricating anterior and posterior portions of an outer shell of the custom cranial deformity correction brace by an additive manufacturing device and based on the corrected symmetrical shape model information sent from the computing device, the anterior and posterior portions each having an inner surface including at least one lining target area and at least one lining-free area, the at least one lining-free area configured to allow for cranial growth of an area of ​​the skull aligned below the lining-free area, the at least one lining-free area having a plurality of ventilation holes extending through the inner surface to an outer surface; A method comprising:

13. The method of claim 12 further comprising: selectively positioning padding along the at least one lining target area of ​​the posterior portion and / or the anterior portion to inhibit cranial growth of one or more of the at least one prominent portion of the skull of the infant when the customized cranial deformity correction device is worn; A method comprising:

14. 13. The method of claim 12, wherein the step of analyzing the three-dimensional model by the computing device and determining at least one prominent region of the skull that requires correction by the cranial deformity correction device includes a substep of applying a machine learning system to the three-dimensional model to identify at least one prominent region and determine a deformation treatment procedure associated with the corrected symmetrical shape model, the machine learning system being generated by processing patient data and multiple past training models of infant skulls.

15. 13. The method according to claim 12, wherein the step of generating, by the computing device, the corrected symmetrical shape model of the skull of the infant based on the determined at least one distinctive portion includes a substep of superimposing at least one padding area for correcting the skull of the infant on the at least one lining-free area of ​​the anterior portion and the posterior portion, the method further comprising: detecting, by the computing device and the three-dimensional model, a cranial shape condition of the infant, including at least one of symmetric brachycephaly, brachycephaly, plagiocephaly, and symmetric scaphocephaly and asymmetric scaphocephaly; A step of determining, by the computing device, a pad arrangement configuration for correcting the baby's head to a shape corresponding to the post-correction symmetrical shape model based on the detected cranial shape state; A method comprising:

16. 13. The method of claim 12, wherein the forward and aft portions of the outer skin shell are a single integral unit.

17. 13. The method of claim 12, wherein the additive manufacturing device comprises at least one of a laser-based stereolithography (SLA) system, a continuous liquid interface manufacturing (CLIP) system, a fused filament fabrication (FFF) system, a selective laser sintering (SLS) system, and a selective heat sintering (SHS) system.

18. The method of claim 12 further comprising: selectively arranging the vents in the asymmetric unlined areas to terminate at a common inner circumference in a series of intersecting and / or spaced apart spiral curves or patterns; wherein a diameter of the vent gradually changes from a maximum diameter near or toward an outer edge of the forward and / or rearward portions to a minimum diameter as the vent approaches the common inner circumference.

19. 1. A system for manufacturing a custom cranial deformity correction device, comprising: at least one memory for storing instructions; At least one processor; wherein the at least one processor executes the instructions to perform the following steps: generating a three-dimensional model of the infant's head based on a three-dimensional scan of the infant's head; analyzing the three-dimensional model to determine at least one prominent area of ​​the head that requires correction with the cranial deformity correction device; generating a corrected symmetrical shape model of the head of the infant based on the determined at least one prominent feature; and having an additive manufacturing device create anterior and posterior portions of an outer shell of the customized cranial deformity correction orthosis based on information of the corrected symmetrical shape model, the anterior and posterior portions each having an inner surface including at least one lining target area and at least one asymmetric lining-free area, the at least one asymmetric lining-free area having a plurality of ventilation holes extending through the inner surface to an outer surface; A system configured to perform a process including:

20. 20. The system of claim 19, The system further comprises a step of generating a post-correction symmetrical shape model of the infant's head based on the determined at least one prominent portion, the step including overlaying at least one pad area for correcting the infant's head on the at least one asymmetric non-lining area of ​​the front and rear portions.

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