Skull orthosis and design method for skull orthosis gap

Abstract

The application relates to a skull orthosis and a design method of a gap of the skull orthosis. The skull orthosis comprises a body, the body encloses an open orthosis cavity; the body is provided with a wearing slit and at least one gap, wherein the bodies on both sides of the wearing slit are separated from each other; the body is provided with a sagittal plane, and the wearing slit and the at least one gap are located on both sides of the sagittal plane. In this way, on one hand, the external force applied in the wearing process can be reduced, so that the skull orthosis is easy to wear; on the other hand, the rebound force of the skull orthosis in the wearing process can be reduced, so that the damage of the skull orthosis to the patient in the wearing process is reduced; on the other hand, the stress condition of the skull orthosis in the wearing process is improved, so that the fatigue performance of the skull orthosis is improved, and the service life of the skull orthosis is further improved.

Description

Technical Field

[0001] This application relates to the field of medical device technology, and in particular to a cranial orthosis and a design method for a notch in the cranial orthosis. Background Technology

[0002] Infants aged 3-18 months are prone to cranial deformities, such as plagiocephaly, brachycephaly, lopsided head, asymmetrical brachycephaly, and scaphoid head. These are all considered cranial deformities. In order to treat the symptoms of cranial deformities, it is generally necessary to correct them with a craniotomy.

[0003] Traditionally, craniotomies are typically manufactured using 3D printing. The process begins with obtaining a model of an infant's head using a scanner. This model is then used to design the corrected head shape, and based on this model, the craniotomy structure is designed, resulting in a 3D model. Finally, this 3D model is imported into a 3D printer for processing. The craniotomy has an opening on its side for wearing. To wear it, the craniotomy must be opened through this opening, and the head inserted into the orthotic cavity.

[0004] However, the above-mentioned cranioid devices have the following problems: they require a large force to wear, making them difficult to put on; they are prone to causing injury to patients during wear; and they have poor fatigue performance, which reduces their service life. Summary of the Invention

[0005] Therefore, it is necessary to provide a design method for a cranial orthosis and a notch in the cranial orthosis to address at least one of the above problems.

[0006] In a first aspect, this application provides a cranial orthopedic device, including a body that forms an open orthopedic cavity; the body has a wearing slit and at least one notch, wherein the body located on both sides of the wearing slit is separated from each other;

[0007] The body has a sagittal plane, and the wearing slit and the at least one notch are located on both sides of the sagittal plane.

[0008] The aforementioned cranial orthosis, by creating a notch in its body and positioning the notch and wearing slit on opposite sides of the sagittal plane, allows the notch to release some of the stress generated by the orthosis's own deformation during wear, thereby reducing stress on the orthosis during the wearing process. This reduces the external force applied during wear, making the orthosis easier to put on; it also reduces the rebound force during wear, thus minimizing injury to the patient; furthermore, it improves the stress distribution on the orthosis during wear, thereby enhancing its fatigue performance and ultimately extending its service life.

[0009] In one embodiment, the body has a first curvature region and a second curvature region adjacent to each other, the curvature of the first curvature region being greater than the curvature of the second curvature region; the notch is located in the first curvature region.

[0010] In one embodiment, the notch extends through the body within the first curvature region.

[0011] In one embodiment, the number of the notches is multiple, and the multiple notches are arranged at intervals on the same side of the sagittal plane.

[0012] Secondly, this application provides a method for designing a notch in a cranial orthopedic device, comprising:

[0013] Establish a simulation model of the cranial orthotics;

[0014] Set the first constraint and the first input parameter;

[0015] Adjust the first input parameter to determine the location of the maximum stress in the simulation model that satisfies the first constraint condition;

[0016] A notch is made at the location of maximum stress in the simulation model.

[0017] In one embodiment, the step of adjusting the first input parameter to determine the location of the maximum stress in the simulation model that satisfies the first constraint includes:

[0018] The deformation displacement and stress values ​​of the simulation model are calculated based on the first input parameters;

[0019] Adjust the first input parameter so that the deformation displacement of the simulation model satisfies the first constraint condition. At this time, the location of the maximum stress value of the simulation model corresponding to the first input parameter is the maximum stress location.

[0020] In one embodiment, the step of creating a notch at the location of maximum stress in the simulation model includes:

[0021] A mathematical model is established using the volume of the simulation model as the objective function;

[0022] Set the second constraint and the second input parameter;

[0023] Adjust the second input parameter to determine the optimal notch size that satisfies the second constraint condition;

[0024] A notch is created at the location of maximum stress in the simulation model according to the optimal notch size.

[0025] In one embodiment, the step of adjusting the second input parameter to determine the optimal notch size that satisfies the second constraint includes:

[0026] Calculate the volume of the simulation model based on the second input parameter;

[0027] The second input parameter is adjusted to make the simulation model meet the second constraint condition, and all the second input parameters that meet the second constraint condition and minimize the volume of the simulation model are obtained; wherein, the second input parameter is the optimal notch size of the simulation model.

[0028] In one embodiment, the first input parameter is the load applied to both sides of the wearing slit of the cranial orthotine, and the second input parameter is the size of the notch.

[0029] In one embodiment, the first constraint is D≤Dx≤1.2D; where Dx is the deformation displacement of the simulation model, and D is the target displacement of the simulation model;

[0030] And / or, the second constraint condition is: Sx < S, Fx ≤ u × F; where Sx is the actual maximum stress of the cranial orthotine, S is the preset maximum stress of the cranial orthotine, Fx is the load applied to both sides of the wearing slit of the cranial orthotine, F is the preset load, and u is the preset coefficient.

[0031] The aforementioned design method for the notch in the cranioplasty involves determining the location of maximum stress in the simulation model through simulation calculations and then creating a notch at that location. This approach serves several purposes: firstly, it reduces the external force applied during wear, making the cranioplasty easier to put on; secondly, it reduces the rebound force of the cranioplasty during wear, thereby minimizing injury to the patient; and thirdly, it improves the stress distribution of the cranioplasty during wear, thus enhancing its fatigue performance and ultimately extending its lifespan. Attached Figure Description

[0032] To more clearly illustrate the technical solutions in the embodiments of this application or the conventional technology, the drawings used in the description of the embodiments or the conventional technology will be briefly introduced below. Obviously, the drawings described below are only some embodiments of this application. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0033] Figure 1 A schematic diagram of the structure of a cranial orthosis provided in an embodiment of this application from a first-view perspective;

[0034] Figure 2 for Figure 1 The diagram shown is a structural schematic of the cranial orthotine from a second-view perspective.

[0035] Figure 3 for Figure 1 A top view of the cranial orthopedic device shown;

[0036] Figure 4 A schematic diagram of the structure of another cranial orthopedic device provided in an embodiment of this application from a first-view perspective;

[0037] Figure 5 for Figure 4 The diagram shown is a structural schematic of the cranial orthotine from a second-view perspective.

[0038] Figure 6 for Figure 2 A top view of the cranial orthopedic device shown;

[0039] Figure 7 This is a schematic diagram of the structure of another cranial orthopedic device provided in an embodiment of this application;

[0040] Figure 8 A schematic flowchart illustrating a method for designing a notch in a cranial orthotic device according to an embodiment of this application;

[0041] Figure 9 for Figure 8 A detailed schematic diagram of the steps in S300 of the design method for the cranial orthotist notch shown;

[0042] Figure 10 for Figure 8 A detailed schematic diagram of the steps in S400 of the design method for the cranial orthotist notch shown;

[0043] Figure 11 for Figure 10 A detailed schematic diagram of the steps in S430 of the design method for the cranial orthotic notch shown.

[0044] Figure label:

[0045] 10-Cranial orthotist; 11-Body; 111-First curvature zone; 112-Second curvature zone; 12-Orthotonic cavity; 13-Wearing slit; 14-Notch; 15-Sagittal plane; 16-Reinforcing part. Detailed Implementation

[0046] To make the above-mentioned objectives, features, and advantages of this application more apparent and understandable, the specific embodiments of this application are described in detail below with reference to the accompanying drawings. Many specific details are set forth in the following description to provide a thorough understanding of this application. However, this application can be implemented in many other ways different from those described herein, and those skilled in the art can make similar modifications without departing from the spirit of this application. Therefore, this application is not limited to the specific embodiments disclosed below.

[0047] In the description of this application, it should be understood that the terms "center", "longitudinal", "lateral", "length", "width", "thickness", "upper", "lower", "front", "rear", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "outer", "clockwise", "counterclockwise", "axial", "radial", "circumferential", etc., indicating the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings, are only for the convenience of describing this application and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation, and therefore should not be construed as a limitation of this application.

[0048] Furthermore, the terms "first" and "second" are used for descriptive purposes only and should not be construed as indicating or implying relative importance or implicitly specifying the number of technical features indicated. Thus, a feature defined as "first" or "second" may explicitly or implicitly include at least one of that feature. In the description of this application, "multiple" means at least two, such as two, three, etc., unless otherwise explicitly specified.

[0049] In this application, unless otherwise expressly specified and limited, the terms "installation," "connection," "joining," and "fixing," etc., should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral part; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium; they can refer to the internal communication of two components or the interaction between two components, unless otherwise expressly limited. Those skilled in the art can understand the specific meaning of the above terms in this application according to the specific circumstances.

[0050] In this application, unless otherwise expressly specified and limited, "above" or "below" the second feature can mean that the first feature is in direct contact with the second feature, or that the first feature is in indirect contact with the second feature through an intermediate medium. Furthermore, "above," "on top of," and "over" the second feature can mean that the first feature is directly above or diagonally above the second feature, or simply that the first feature is at a higher horizontal level than the second feature. "Below," "below," and "under" the second feature can mean that the first feature is directly below or diagonally below the second feature, or simply that the first feature is at a lower horizontal level than the second feature.

[0051] It should be noted that when an element is referred to as being "fixed to" or "set on" another element, it can be directly on the other element or there may be an intervening element. When an element is considered to be "connected to" another element, it can be directly connected to the other element or there may be an intervening element. The terms "vertical," "horizontal," "upper," "lower," "left," "right," and similar expressions used herein are for illustrative purposes only and do not represent the only possible implementation.

[0052] When used herein, the singular forms of “a,” “an,” and “the” may also include the plural forms unless the context clearly indicates otherwise. It should also be understood that the terms “comprising / including” or “having,” etc., specify the presence of the stated features, wholes, steps, operations, components, parts, or combinations thereof, but do not preclude the possibility of the presence or addition of one or more other features, wholes, steps, operations, components, parts, or combinations thereof. Meanwhile, in this specification, the term “and / or” includes any and all combinations of the associated listed items.

[0053] Firstly, referring to Figures 1-3As shown, this application embodiment provides a cranioplasty 10, which includes a body 11 that forms an open orthotic cavity 12. It should be noted that "open" means the orthotic cavity 12 has at least one opening; that is, the orthotic cavity 12 has an opening near the patient's neck, allowing the patient's head to enter the orthotic cavity 12 when wearing the cranioplasty 10. Furthermore, the orthotic cavity 12 may also have an opening near the top of the patient's head, which improves the breathability of the cranioplasty 10 and thus enhances wearing comfort.

[0054] Specifically, the body 11 has a wearing slit 13 and at least one notch 14, wherein the body 11 located on both sides of the wearing slit 13 is separated from each other. The body 11 has a sagittal plane 15, and the wearing slit 13 and the at least one notch 14 are respectively located on both sides of the sagittal plane 15.

[0055] It should be noted here that when wearing the cranial orthosis 10, the main body 11 on both sides of the wearing slit 13 can be pried open from the wearing slit 13, thereby enlarging the opening of the cranial orthosis 10 and allowing the head to be inserted into the orthotic cavity 12. (Refer to...) Figure 3 As shown, "Sagittal plane 15" can be understood as: a plane that passes through the center of cranial orthotine 10 and divides cranial orthotine 10 into two.

[0056] The aforementioned cranial orthosis 10, by creating a notch 14 in its body 11 and positioning the notch 14 and the wearing slit 13 on opposite sides of the sagittal plane 15, allows the notch 14 to release some of the stress generated by the deformation of the cranial orthosis 10 during wear, thereby reducing the stress on the cranial orthosis 10 during the wearing process. This reduces the external force applied during wear, making the cranial orthosis 10 easier to wear; it also reduces the rebound force of the cranial orthosis 10 during wear, thus reducing injury to the patient; furthermore, it improves the stress distribution of the cranial orthosis 10 during wear, thereby improving its fatigue performance and ultimately extending its service life.

[0057] It is understood that there may be only one notch 14. In a preferred embodiment, this single notch 14 may be located at the point of maximum stress in the cranial orthosis 10. The point of maximum stress in the cranial orthosis 10 can be determined through simulation.

[0058] By placing the notch 14 at the point of maximum stress, the maximum stress on the cranioplasty 10 during wear can be effectively reduced. On the one hand, this reduces the external force applied during wear, making the cranioplasty 10 easier to wear; on the other hand, it reduces the rebound force of the cranioplasty 10 during wear, thereby reducing injury to the patient; furthermore, it improves the stress condition of the cranioplasty 10 during wear, thereby improving the fatigue performance of the cranioplasty 10 and thus increasing its service life.

[0059] In one embodiment, reference Figure 2 As shown, the body 11 has a first curvature region 111 and a second curvature region 112 that are adjacent to each other, and the curvature of the first curvature region 111 is greater than the curvature of the second curvature region 112. The notch 14 is located in the first curvature region 111. In one example, refer to... Figure 2 Taking the orientation shown in the figure as an example, the first curvature zone 111 can be located at the top of the cranial orthosis 10, and the second curvature zone 112 can be located below the first curvature zone 111. It should be noted here that the attached figure is only for illustrative purposes to show the range of the first curvature zone 111 and the second curvature zone 112, and does not mean that the first curvature zone 111 and the second curvature zone 112 are limited to the range shown in the figure.

[0060] It is understandable that when the cranial orthosis 10 is opened, the stress in the area with greater curvature is greater. By opening a notch 14 in the area with greater stress, the stress in that area can be reduced, thereby reducing the stress of the cranial orthosis 10 when worn.

[0061] In one embodiment, the notch 14 extends through the body 11 within the first curvature region 111. This minimizes the stress on the craniotomy 10 during wear and improves the stress distribution of the craniotomy 10 during the wearing process.

[0062] In one embodiment, there are multiple notches 14, which are spaced apart on the same side of the sagittal plane 15. In this way, the stress generated by the deformation of the cranial orthosis 10 due to its own deformation can be released through the multiple notches 14, thereby further reducing the stress on the cranial orthosis 10 during the wearing process.

[0063] Understandably, referring to Figure 1 as well as Figures 4-6 As shown, the shape of the notch 14 can be a narrow slit, or it can be a notch 14 that is wider and shorter than a slit. The embodiments of this application do not limit the type of slit.

[0064] In one embodiment, reference Figure 7As shown, the notch 14 can also penetrate the body 11. In this case, a reinforcing part 16 can be provided on the body 11, and the reinforcing part 16 connects the body 11 on both sides of the notch 14.

[0065] Secondly, combining Figures 1-7 and reference Figure 8 As shown in the embodiment of this application, a method for designing a notch in a cranial orthotist is provided, the method comprising:

[0066] S100: Establish a simulation model of the cranial orthotist. That is, establish a three-dimensional model of the cranial orthotist 10.

[0067] S200: Set the first constraint conditions and the first input parameters. It is understood that boundary conditions for the simulation model can also be set in this step.

[0068] S300: Adjust the first input parameter to determine the location of the maximum stress in the simulation model that satisfies the first constraint condition.

[0069] S400: A notch is created at the location of maximum stress in the simulation model.

[0070] The above-mentioned design method for the notch in the cranial orthosis involves determining the location of maximum stress in the simulation model through simulation calculations and creating a notch 14 at the location of maximum stress. This approach serves several purposes: firstly, it reduces the external force applied during wear, making the cranial orthosis 10 easier to wear; secondly, it reduces the rebound force of the cranial orthosis 10 during wear, thereby reducing injury to the patient; and thirdly, it improves the stress distribution of the cranial orthosis 10 during wear, thus enhancing its fatigue performance and ultimately increasing its service life.

[0071] In one embodiment, reference Figure 9 As shown, S300: The step of adjusting the first input parameter to determine the location of the maximum stress in the simulation model that satisfies the first constraint condition includes:

[0072] S310: The deformation displacement and stress values ​​of the simulation model are calculated based on the first input parameters.

[0073] Specifically, the first input parameter is the load applied to both sides of the wearing slit 13 of the craniotomy 10. This load is the force applied when the craniotomy 10 is worn to open the wearing slit 13. Here, deformation displacement refers to the actual deformation displacement of the craniotomy 10 after the load is applied. Stress value refers to the maximum stress value on the body 11 of the craniotomy 10 after the load is applied.

[0074] S320: Adjust the first input parameter so that the deformation displacement of the simulation model satisfies the first constraint condition. At this time, the location of the maximum stress value of the simulation model corresponding to the first input parameter is the maximum stress location. It can be understood that in this step, it is necessary to continuously adjust the value of the first input parameter to find the first input parameter that can satisfy the first constraint condition. The location of the maximum stress value obtained according to the first input parameter is the maximum stress location.

[0075] In one embodiment, the first constraint is D ≤ Dx ≤ 1.2D. Here, Dx is the deformation displacement of the simulation model, and D is the target displacement of the simulation model.

[0076] Reference Figure 4 As shown, when a certain load force F is applied to the wearing slit 13 of the craniotomy 10 to pry it open, the craniotomy 10 can only allow the head to enter the orthotic cavity 12 of the craniotomy 10 if it generates a certain amount of displacement. The target displacement D can be understood as: the amount of displacement generated by the craniotomy 10 when the head can just enter the orthotic cavity 12; or, the minimum amount of displacement required by the craniotomy 10 when the head needs to be fully inserted into the orthotic cavity 12. It can be understood that when the actual displacement is greater than the target displacement D, the head can also be inserted into the orthotic cavity 12.

[0077] By ensuring that the deformation of the simulation model satisfies the first constraint condition, it can be guaranteed that the first input parameter (the load applied to both sides of the wearing slit 13 of the cranial orthosis 10) can open the cranial orthosis 10 so that the head can be inserted into the orthotic cavity 12. It can also be guaranteed that the cranial orthosis 10 will not undergo large deformation, thus avoiding fatigue caused by the cranial orthosis 10 being subjected to large external forces.

[0078] Furthermore, the first constraint condition can also be D = Dx. In this way, the force F (i.e., the first input parameter) required to be applied when the head can just fit into the orthopedic cavity 12 and the position of maximum stress of the cranial orthotist 10 can be simulated.

[0079] In one embodiment, reference Figure 10 As shown, S400: The step of creating a notch at the location of maximum stress in the simulation model includes:

[0080] S410: Establish a mathematical model with the volume of the simulation model as the objective function.

[0081] S420: Set the second constraint and the second input parameter. It is understood that boundary conditions for the simulation model can also be set in this step.

[0082] S430: Adjust the second input parameter to determine the optimal notch size that satisfies the second constraint condition.

[0083] S440: Create a notch at the location of maximum stress in the simulation model based on the optimal notch size.

[0084] It should be noted that the above steps are equivalent to optimizing the notch 14 of the cranial orthosis 10 so that the notch 14 can reduce the maximum stress of the cranial orthosis 10, while also reducing the weight of the cranial orthosis 10 and improving the comfort of wearing the cranial orthosis 10.

[0085] In one embodiment, the second input parameter is the size of the notch 14. Specifically, refer to... Figure 6 As shown, the dimensions of the notch 14 can be the length L and the width W of the notch 14.

[0086] In one embodiment, reference Figure 11 As shown, S430: The steps for adjusting the second input parameter to determine the optimal notch size that satisfies the second constraint include:

[0087] S431: Calculate the volume of the simulation model based on the second input parameter. This step can be understood as: inputting the length L and width W of notch 14 into the simulation model, and calculating the volume of the simulation model.

[0088] S432: Adjust the second input parameter to make the simulation model meet the second constraint condition, and obtain all the second input parameters that meet the second constraint condition and minimize the volume of the simulation model. Here, the second input parameter is the optimal notch size of the simulation model.

[0089] Specifically, the second constraint is: Sx < S, Fx ≤ u × F. Where Sx is the actual maximum stress of the cranial orthosis 10, S is the preset maximum stress of the cranial orthosis 10, Fx is the load applied to both sides of the wearing slit 13 of the cranial orthosis 10, F is the preset load, and u is the preset coefficient. In one example, 0.5 ≤ u < 1.

[0090] It should be noted that in this step, Fx needs to be input, and then the value of the second input parameter is continuously adjusted. The actual maximum stress Sx corresponding to each second input parameter is calculated. When Sx < S, the second input parameter and its corresponding volume are recorded. In this way, multiple second input parameters satisfying the second constraint condition can be obtained. Then, the volumes corresponding to these second input parameters are compared, and the simulation model with the smallest volume is selected. The second input parameter in this simulation model is the optimal notch size.

[0091] By using the above method, an opening with an optimal notch size is designed on the cranial orthosis 10. This allows for a minimum weight design of the cranial orthosis 10 while ensuring better stress conditions and a smaller applied force load. As a result, the cranial orthosis 10 has better fatigue performance, ease of wear, and comfort.

[0092] It should be understood that, although Figure 8 The steps in the flowchart are shown sequentially as indicated by the arrows, but these steps are not necessarily executed in the order indicated by the arrows. Unless otherwise specified herein, there is no strict order in which these steps are executed, and they can be performed in other orders. Figure 8 At least some of the steps in the process may include multiple steps or multiple stages. These steps or stages are not necessarily completed at the same time, but may be executed at different times. The execution order of these steps or stages is not necessarily sequential, but may be executed in turn or alternately with other steps or at least some of the steps or stages in other steps.

[0093] In the description of this specification, references to terms such as "some embodiments," "other embodiments," and "ideal embodiments" indicate that a specific feature, structure, material, or characteristic described in connection with that embodiment or example is included in at least one embodiment or example of the invention. In this specification, the illustrative descriptions of the above terms do not necessarily refer to the same embodiments or examples.

[0094] The technical features of the above embodiments can be combined in any way. For the sake of brevity, not all possible combinations of the technical features of the above embodiments are described. However, as long as there is no contradiction in the combination of these technical features, they should be considered to be within the scope of this specification.

[0095] The embodiments described above are merely illustrative of several implementation methods of this application, and while the descriptions are relatively specific and detailed, they should not be construed as limiting the scope of the patent application. It should be noted that those skilled in the art can make various modifications and improvements without departing from the concept of this application, and these all fall within the protection scope of this application. Therefore, the protection scope of this patent application should be determined by the appended claims.

Claims

1. A method for designing a notch in a cranial orthotic device, characterized in that, include: Establish a simulation model of the cranial orthotics; Set a first constraint and a first input parameter; the first input parameter is the load applied to both sides of the wearing slit of the cranial orthotist; the first constraint is D≤Dx≤1.2D; where Dx is the deformation displacement of the simulation model and D is the target displacement of the simulation model; Adjust the first input parameter to determine the location of the maximum stress in the simulation model that satisfies the first constraint condition; A notch is made at the location of maximum stress in the simulation model; The step of adjusting the first input parameter to determine the location of the maximum stress in the simulation model that satisfies the first constraint includes: The deformation displacement and stress values ​​of the simulation model are calculated based on the first input parameters; Adjust the first input parameter so that the deformation displacement of the simulation model satisfies the first constraint condition. At this time, the location of the maximum stress value of the simulation model corresponding to the first input parameter is the maximum stress location.

2. The design method for the cranial orthotic notch according to claim 1, characterized in that, The step of creating a notch at the location of maximum stress in the simulation model includes: A mathematical model is established using the volume of the simulation model as the objective function; Set a second constraint and a second input parameter; the second input parameter is the size of the notch; the second constraint is: Sx < S, Fx ≤ u × F; where Sx is the actual maximum stress of the cranial orthotine, S is the preset maximum stress of the cranial orthotine, Fx is the load applied to both sides of the wearing slit of the cranial orthotine, F is the preset load, and u is the preset coefficient. Adjust the second input parameter to determine the optimal notch size that satisfies the second constraint condition; A notch is created at the location of maximum stress in the simulation model according to the optimal notch size.

3. The method for designing the notch in a cranial orthosis according to claim 2, characterized in that, The step of adjusting the second input parameter to determine the optimal notch size that satisfies the second constraint includes: Calculate the volume of the simulation model based on the second input parameter; The second input parameter is adjusted to make the simulation model meet the second constraint condition, and all the second input parameters corresponding to the conditions that meet the second constraint condition and minimize the volume of the simulation model are obtained; wherein, the second input parameter is the optimal notch size of the simulation model.

4. A cranial orthotic device, characterized in that, The cranial orthosis, obtained by the design method described in any one of claims 1-3, includes a body (11) that forms an open orthotic cavity (12); the body (11) has a wearing slit (13) and at least one notch (14) on it, wherein the body (11) located on both sides of the wearing slit (13) is separated from each other; The body (11) has a sagittal plane (15), and the wearing slit (13) and the at least one notch (14) are located on both sides of the sagittal plane (15).

5. The cranial orthopedic device according to claim 4, characterized in that, The body (11) is provided with a first curvature region (111) and a second curvature region (112) adjacent to each other, the curvature of the first curvature region (111) is greater than the curvature of the second curvature region (112); the notch (14) is located in the first curvature region (111).

6. The cranial orthopedic device according to claim 5, characterized in that, The notch (14) penetrates the body (11) within the first curvature region (111).

7. The cranial orthopedic device according to claim 4, characterized in that, The number of the notches (14) is multiple, and the multiple notches (14) are arranged at intervals on the same side of the sagittal plane (15).

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