A method for manufacturing a skull orthopedic fixator and a skull orthopedic fixator

Abstract

A method for manufacturing a skull orthopedic fixator and the skull orthopedic fixator, wherein the manufacturing method comprises obtaining a standard head shape of the patient according to the patient's craniosynostosis symptoms and postoperative head shape; obtaining a target head shape of the patient according to the obtained standard head shape of the patient and the skull growth parameters corresponding to the patient; and establishing a skull orthopedic fixator model of the patient according to the obtained target head shape of the patient.

Description

Technical Field

[0001] The present invention relates to the technology of skull orthopedic fixator, and in particular to a manufacturing method of skull orthopedic fixator and the skull orthopedic fixator. Background Art

[0002] Craniostenosis refers to a type of disease characterized by skull deformity caused by premature closure of cranial sutures in infants and young children. According to medical reports, its incidence rate is about 1 / 2500. At present, craniosynostosis is mainly treated by surgery to expand the volume of the cranial cavity, reduce intracranial pressure, protect brain function, and improve the appearance of the head. And after surgery, the skull orthopedic fixator is worn for more than 6 months to protect the brain and fix the skull after surgery. Due to the complexity and diversity of craniosynostosis, especially syndromic craniosynostosis, there is currently no unified surgical method and standard procedure. Summary of the invention

[0003] The present application provides a method for manufacturing a skull orthopedic fixator and a skull orthopedic fixator, which can accurately fit the patient and guide the patient's skull growth recovery.

[0004] The present application provides a method for manufacturing a cranial orthopedic fixator, comprising:

[0005] According to the patient's craniosynostosis symptoms and postoperative head shape, the patient's standard head shape was obtained;

[0006] Obtaining a target head shape for the patient according to the obtained standard head shape for the patient and the skull growth parameters corresponding to the patient;

[0007] A skull orthopedic fixator model of the patient is established according to the obtained target head shape of the patient; or a skull orthopedic fixator model of the patient is established according to the obtained target head shape and standard head shape of the patient.

[0008] In an exemplary embodiment, obtaining the standard head shape of the patient according to the patient's craniosynostosis symptoms and postoperative head shape includes:

[0009] According to the patient's craniosynostosis symptoms, select the corresponding standard head template;

[0010] The selected standard head shape template is modified according to the postoperative head shape to obtain a standard head shape;

[0011] Among them, the standard head shape includes a skull growth reserved space area and a skull growth constraint area. The skull growth reserved space area is set to correspond to the growth restricted side of the patient due to craniosynostosis, and the skull growth constraint area is set to correspond to the compensatory growth area caused by craniosynostosis of the patient.

[0012] In an exemplary embodiment, obtaining the target head shape of the patient according to the obtained standard head shape of the patient and the skull growth parameters corresponding to the patient includes:

[0013] According to the first characteristic parameter of the patient, determining the percentile of the actual head circumference growth and development of the patient in the first head circumference percentile value list;

[0014] According to the second characteristic parameter of the patient, determining the percentile of the reference head circumference growth and development corresponding to the patient in the second head circumference percentile value list;

[0015] According to the determined actual head circumference growth percentile and the reference head circumference growth percentile, the target head circumference growth percentile of the patient is obtained;

[0016] The target head shape is obtained according to the standard head shape and the obtained percentile of the target head circumference growth and development.

[0017] In an exemplary embodiment, obtaining the target head shape according to the standard head shape and the obtained percentile of the target head circumference growth and development includes:

[0018] Obtaining estimated values ​​of skull growth parameters of the target head shape according to the percentile of the target head circumference growth and development, wherein the skull growth parameters include head circumference and cranial brain volume;

[0019] Calculating the differences between the head circumference and cranial brain volume of the postoperative head shape and the head circumference and cranial brain volume of the standard head shape;

[0020] The skull growth reserved space area of ​​the standard head shape is adjusted according to the calculated difference to obtain the target head shape, so that the head circumference and cranial brain volume values ​​of the target head shape match the estimated values ​​of the head circumference and cranial brain volume of the target head shape.

[0021] In an exemplary embodiment, obtaining the target head circumference growth percentile of the patient according to the determined actual head circumference growth percentile and the reference head circumference growth percentile comprises:

[0022] In the first head circumference percentile value list or the second head circumference percentile value list, a head circumference growth and development percentile between the actual head circumference growth and development percentile and the reference head circumference growth and development percentile is selected as the target head circumference growth and development percentile.

[0023] In an exemplary embodiment, the first characteristic parameters of the patient include age, gender, and postoperative head circumference, and the second characteristic parameters of the patient include age, gender, height, and weight.

[0024] In an exemplary embodiment, the symptoms of craniosynostosis include one or more of: frontal synostosis, bilateral coronal synostosis, unilateral coronal synostosis, sagittal synostosis, lambdoid synostosis, and unilateral lambdoid synostosis.

[0025] In an exemplary embodiment, the method for manufacturing the cranial orthopedic fixator further comprises:

[0026] Using the obtained target head shape of the patient as the inner contour surface of the cranial orthopedic fixator model;

[0027] The outer contour surface of the cranial orthopedic fixator model is obtained by performing an equidistant offset on the target head shape; or, the outer contour surface of the cranial orthopedic fixator model is obtained by performing an equidistant offset on the standard head shape.

[0028] In an exemplary embodiment, the method further comprises:

[0029] A local feature corresponding to the patient is generated on the inner contour surface and the outer contour surface of the cranial orthopedic fixator model; the local feature includes at least one of the following:

[0030] A frontal area corresponding to the forehead of the patient, a front baffle corresponding to the front side of the auricle of the patient, and a rear baffle corresponding to the rear side of the auricle of the patient.

[0031] In an exemplary embodiment, the height of the forehead area is set to correspond to 0-5 cm above the patient's eyebrows or to cover the eyebrow position; the width of the front baffle ranges from 2-8 cm, and the front baffle is set to be 0.5-2 cm away from the front point of the patient's auricle; the width of the rear baffle ranges from 2-5 cm and is set to cover the patient's posterior mastoid position.

[0032] In an exemplary embodiment, the cranial orthopedic fixator model is an integrally molded part; or

[0033] The method also includes: dividing the skull orthopedic fixator model into a first fixed shell and a second fixed shell that are spliced ​​to each other, wherein the splicing position of the first fixed shell and the second fixed shell does not pass through the skull growth constraint area and / or passes through the skull growth reserved space area.

[0034] In an exemplary embodiment, the skull top region of the skull orthopedic fixator model is a fully wrapped design; or

[0035] The method further comprises: setting a hole in the skull top region of the skull orthopedic fixator model, wherein the diameter of the hole ranges from 5 cm to 12 cm.

[0036] In an exemplary embodiment, the method further comprises:

[0037] A ventilation area is provided on the cranial orthopedic fixator model, and ventilation holes are provided on the ventilation area. The ventilation area and the ventilation holes are set in at least one of the following ways:

[0038] The air permeable area includes a space reserved for skull growth of the skull orthopedic fixator;

[0039] The air permeable area includes other areas except the skull growth restriction area of ​​the skull orthopedic fixator;

[0040] The breathable zone includes multiple breathable sub-regions, and the sizes of the multiple breathable holes in the same breathable sub-region are consistent, or the multiple breathable holes in the same breathable sub-region; the sizes of the breathable holes gradually change and the apertures of the breathable holes gradually decrease from the central region close to the breathable sub-region to the edge region close to the breathable sub-region; the sizes of the breathable holes in different breathable sub-regions are equal or unequal.

[0041] In an exemplary embodiment, the skull orthopedic fixator model is configured to include an outer shell and an inner shell disposed within the outer shell, the inner surface of the inner shell forming the inner contour surface of the skull orthopedic fixator model, and the outer surface of the outer shell forming the outer contour surface of the skull orthopedic fixator model.

[0042] An embodiment of the present application provides a skull orthopedic fixator, comprising: a skull orthopedic fixator model obtained according to the skull orthopedic fixator design method as described in any of the above embodiments.

[0043] Compared with the related art, the manufacturing method of the cranial orthopedic fixator of the embodiment of the present application is based on the standard head shape and the target head shape obtained based on the symptoms of craniosynostosis and the postoperative head shape of the patient, so the accuracy is high. In addition, the present application helps guide the patient in the process of recovering the postoperative head shape to the standard head shape by setting the target head shape to establish the model, so that corrections can be made regularly during the growth period to help the patient gradually recover to the standard head shape.

[0044] Other features and advantages of the present application will be described in the following description, and partly become apparent from the description, or be understood by implementing the present application. Other advantages of the present application can be realized and obtained by the schemes described in the description and the drawings. BRIEF DESCRIPTION OF THE DRAWINGS

[0045] The accompanying drawings are used to provide an understanding of the technical solution of the present application and constitute a part of the specification. Together with the embodiments of the present application, they are used to explain the technical solution of the present application and do not constitute a limitation on the technical solution of the present application.

[0046] Figure 1 A flowchart of a method for manufacturing a cranial orthopedic fixator according to an embodiment of the present application;

[0047] Figure 2a-2c A schematic diagram of a standard head shape template corresponding to premature closure of the frontal suture according to an embodiment of the present application;

[0048] Figure 3a-3c Schematic diagrams of the top view, side view and rear view of the standard head shape template corresponding to sagittal synostosis according to the embodiment of the present application;

[0049] Figure 4a-4c Schematic diagrams of the top view, side view and rear view of the standard head shape template corresponding to bilateral coronal suture synostosis according to the embodiment of the present application;

[0050] Figure 5a-5c Schematic diagrams of the top view, side view and rear view of the standard head shape template corresponding to unilateral coronal suture synostosis according to the embodiment of the present application;

[0051] Figure 6a-6c Schematic diagrams of the top view, side view, and rear view of the standard head shape template corresponding to bilateral lambdoid suture closure according to the embodiment of the present application;

[0052] Figure 7a-7c Schematic diagrams of the top view, side view, and rear view of the standard head shape template corresponding to unilateral lambdoid suture premature closure according to the embodiment of the present application;

[0053] Figure 8a A stereoscopic view of a skull orthopedic fixator model with a single-side opening according to an embodiment of the present application

[0054] Figure 8b An exemplary view of a top opening model of a cranial orthopedic fixator according to an embodiment of the present application;

[0055] Figure 9a Schematic diagram of a standard head shape and a target head shape according to an embodiment of the present application;

[0056] Figure 9b A schematic diagram of an example of uniform thickness of a cranial orthopedic fixator according to an embodiment of the present application;

[0057] Fig.9c A schematic diagram of an example of non-uniform thickness of a cranial orthopedic fixator according to an embodiment of the present application;

[0058] Figure 9d A schematic diagram of another example of non-uniform thickness of a cranial orthopedic fixator according to an embodiment of the present application;

[0059] Fig.10a A three-dimensional diagram of a cranial orthopedic fixator product according to an embodiment of the present application;

[0060] Fig.10b for Fig.10a3D exploded view of

[0061] Fig.11 This is a diagram showing an application example of the method for manufacturing a cranial orthopedic fixator according to an embodiment of the present application. DETAILED DESCRIPTION

[0062] The present application describes multiple embodiments, but the description is exemplary rather than restrictive, and it is obvious to those skilled in the art that there may be more embodiments and implementations within the scope of the embodiments described in the present application. Although many possible feature combinations are shown in the drawings and discussed in the specific embodiments, many other combinations of the disclosed features are also possible. Unless specifically limited, any feature or element of any embodiment may be used in combination with any other feature or element in any other embodiment, or may replace any other feature or element in any other embodiment.

[0063] The present application includes and contemplates combinations of features and elements known to those of ordinary skill in the art. The embodiments, features and elements disclosed in the present application may also be combined with any conventional features or elements to form a unique invention scheme defined by the claims. Any features or elements of any embodiment may also be combined with features or elements from other invention schemes to form another unique invention scheme defined by the claims. Therefore, it should be understood that any feature shown and / or discussed in the present application may be implemented individually or in any appropriate combination. Therefore, except for the limitations made according to the attached claims and their equivalents, the embodiments are not subject to other restrictions. In addition, various modifications and changes may be made within the scope of protection of the attached claims.

[0064] In addition, when describing representative embodiments, the specification may have presented the method and / or process as a specific sequence of steps. However, to the extent that the method or process does not rely on the specific order of the steps described herein, the method or process should not be limited to the steps of the specific order described. As will be understood by those of ordinary skill in the art, other sequences of steps are also possible. Therefore, the specific sequence of the steps set forth in the specification should not be interpreted as a limitation to the claims. In addition, the claims for the method and / or process should not be limited to the steps of performing them in the order written, and those skilled in the art can easily understand that these sequences can be changed and still remain within the spirit and scope of the embodiments of the present application.

[0065] The embodiment of the present application provides a method for manufacturing a skull orthopedic fixator, which is generally suitable for patients in the skull growth period, such as infants, toddlers, children, and of course teenagers or adults. This article takes infants as an example for detailed description.

[0066] like Figure 1 As shown, the embodiment of the present application provides a method for manufacturing a cranial orthopedic fixator, comprising the following operations:

[0067] S1. Obtain the patient's standard head shape based on the patient's craniosynostosis symptoms and postoperative head shape;

[0068] S2, obtaining a target head shape for the patient according to the obtained standard head shape for the patient and the skull growth parameters corresponding to the patient;

[0069] S3. Establishing a skull orthopedic fixator model for the patient according to the obtained target head shape of the patient; or establishing a skull orthopedic fixator model for the patient according to the obtained target head shape and standard head shape of the patient;

[0070] S4. Manufacturing a skull orthopedic fixator for the patient according to the established skull orthopedic fixator model for the patient.

[0071] The manufacturing method of the cranial orthopedic fixator of the embodiment of the present application is based on the cranial orthopedic fixator model established based on the standard head shape and the target head shape obtained according to the symptoms of craniosynostosis of the patient and the postoperative head shape, so as to have high accuracy. In addition, the present application helps guide the patient in the process of recovering the postoperative head shape to the standard head shape by setting the target head shape to establish the model, so that corrections can be made regularly during the growth period to assist the patient in gradually recovering to the standard head shape.

[0072] The postoperative head shape of the patient described in operation S1 can be obtained by scanning the postoperative skull of the patient to obtain three-dimensional scanning data. The postoperative head shape is obtained by a doctor through three-dimensional scanning after performing surgical treatment on the patient's preoperative head shape. In an exemplary embodiment, the three-dimensional scanning data can be obtained by a laser scanner. Among them, the three-dimensional scanning data may include postoperative head circumference, skull length, skull width, skull ratio CR, oblique diameter A, oblique diameter B, oblique diameter difference CVA, skull vertex asymmetry index, brain volume, bilateral ear displacement, etc.

[0073] The operation S1 of "obtaining the standard head shape of the patient according to the symptoms of craniosynostosis and the postoperative head shape of the patient" includes the following operations:

[0074] S11. According to the patient's craniosynostosis symptoms, select a corresponding standard head shape template from a standard head shape template set; the standard head shape template set stores a plurality of standard head shape templates corresponding to the symptoms of craniosynostosis.

[0075] S12, adjusting the selected standard head shape template according to the postoperative head shape to obtain a standard head shape;

[0076] The standard head shape includes a skull growth reserved space area and a skull growth constraint area. The skull growth reserved space area corresponds to the growth restricted side of the patient due to craniosynostosis, and the skull growth constraint area corresponds to the compensatory growth area caused by craniosynostosis. The above adjustment to the selected standard head shape template is generally to reduce or enlarge.

[0077] Standard head type (ref. Figure 9a The dotted outline in the middle is the most ideal head shape matched to the child's postoperative head shape. There may be a large gap between the standard head shape and the postoperative head shape, so it is necessary to perform iterative adjustments in stages and periodically. In each stage, the target head shape between the standard head shape and the current head shape (reference Figure 9a The solid line contour in the middle is used as the inner contour surface to generate a cranial orthopedic fixator, which is corrected regularly during the growth period to help the patient gradually return to the standard head shape.

[0078] In an exemplary embodiment, the standard head shape template can be obtained by searching the "Health Industry Standards of the People's Republic of China: Growth Standards for Children Under 7 Years Old". Symptoms of craniosynostosis include frontal suture closure, bilateral coronal suture closure, unilateral coronal suture closure, sagittal suture closure, lambdoid suture closure, unilateral lambdoid suture closure, etc. For each symptom of craniosynostosis in the standard head shape template set, there is a corresponding standard head shape template: Figure 2a-2c Standard head shape template corresponding to premature synostosis; Figure 3a-3c Standard head shape template corresponding to sagittal synostosis; Figure 4a-4c Standard head template corresponding to bilateral coronal suture synostosis; Figure 5a-5c Standard head template corresponding to unilateral coronal suture synostosis; Figure 6a-6c Standard head shape template corresponding to bilateral lambdoid suture synostosis; Figure 7a-7c Standard head shape template corresponding to unilateral lambdoid synostosis. In each view, the thinner solid line corresponds to the symptomatic head shape, the thicker solid line corresponds to the standard head shape of the symptomatic head shape repair, and the dotted line is the cranial suture closed due to craniosynostosis. For each symptom of craniosynostosis, three views from top, side, and back are shown.

[0079] After selecting the corresponding standard head shape template, you can refer to the baby's age, gender, head circumference, skull top, auricle, tragus, nasal root, frontal bone, parietal bone, occipital bone, fontanelle and other growth and development data, combined with the corresponding growth and development rules in the skull development database, to predict the child's skull development process in the next 1-6 months, and combine medical indicators such as skull index and symmetry index, as well as modify the standard head shape template through the baby's postoperative head shape scanning data to generate a standard head shape, so that it can more accurately adapt to the child's head shape.

[0080] The generated standard head shape needs to take into account the type of craniosynostosis in children, and has certain constraints on the current postoperative head shape. Therefore, the standard head shape has a skull growth reserved space area A and a skull growth constraint area B. The skull growth reserved space area A is concentrated on the side with growth restriction due to craniosynostosis, providing growth space for the patient's skull after surgery; the skull growth constraint area B is concentrated in the compensatory growth area caused by craniosynostosis, limiting the growth rate of the skull. By setting up the skull growth reserved space area A and the skull growth constraint area B, the growth balance of the patient's skull is achieved, and finally the head shape is close to or grows into the standard head shape.

[0081] The skull index of the standard head shape ranges from 80 to 90, and the skull asymmetry index ranges from 0 to 3.5. The constraint relationship between the standard head shape and different craniosynostosis can be referred to the attached figure (the space between the standard head shape and the postoperative head shape is the reserved space, and the overlapping area is the constraint area). Because children usually have multiple craniosynostosis, and because of the differences and complexity of developmental conditions, a comprehensive design is required to obtain a standard head shape.

[0082] The step of obtaining the target head shape of the patient according to the obtained standard head shape of the patient and the skull growth parameters corresponding to the patient in operation S2 includes the following operations:

[0083] S21. According to the first characteristic parameter of the patient, determine the percentile of the actual head circumference growth and development of the patient in the first head circumference percentile value list; wherein the first characteristic parameter includes age, gender, and postoperative head circumference, etc.

[0084] S22. Determine the reference head circumference growth percentile corresponding to the patient in the second head circumference percentile value list according to the second characteristic parameter of the patient; wherein the second characteristic parameter includes age, gender, height and weight, etc.

[0085] S23, obtaining the target head circumference growth and development percentile of the patient according to the determined actual head circumference growth and development percentile and the reference head circumference growth and development percentile;

[0086] S24. Obtain the target head shape according to the standard head shape and the target head circumference growth percentile.

[0087] As shown in Table A, a list of percentile values ​​of head circumference for boys aged 0-3 years is shown. The corresponding percentile of actual head circumference growth and development can be found in Table A through the patient's first characteristic parameter, such as age (usually corresponding to age in months for infants), gender and postoperative head circumference. As shown in Table B, another list of percentile values ​​of head circumference for boys aged 0-3 years is shown. The corresponding percentile of reference head circumference growth and development can be found through the patient's second characteristic parameter, such as age, gender, height and weight. Generally, due to the skull disease of the child, there is a gap between the actual percentile of head circumference growth and development and the reference percentile of head circumference growth and development, and adjustment is required to obtain the target percentile of head circumference growth and development.

[0088] In an exemplary embodiment, the operation S23 of “obtaining the target head circumference growth percentile of the patient according to the determined actual head circumference growth percentile and the reference head circumference growth percentile” includes the following operations:

[0089] S231. Select a head circumference growth and development percentile between the actual head circumference growth and development percentile and the reference head circumference growth and development percentile from the first head circumference percentile value list or the second head circumference percentile value list as the target head circumference growth and development percentile.

[0090] Operation 24 of “obtaining the target head shape according to the standard head shape and the target head circumference growth percentile” includes the following operations:

[0091] S241. Obtain estimated values ​​of skull growth parameters of the target head shape according to the percentile of the target head circumference growth and development, the skull growth parameters including head circumference and cranial brain volume;

[0092] S242, calculating the difference between the head circumference and cranial brain volume of the postoperative head shape and the head circumference and cranial brain volume of the standard head shape;

[0093] S243. Adjust the reserved space of the standard head shape according to the calculated difference to obtain the target head shape, so that the head circumference and cranial brain volume of the target head shape match the estimated values ​​of the head circumference and cranial brain volume of the target head shape.

[0094] The adjustment of the reserved space is generally a reduction of the standard head shape. The matching of the head circumference and cranial brain volume of the target head shape with the estimated head circumference and cranial brain volume of the target head shape means that the values ​​are consistent or nearly consistent.

[0095] In this embodiment, the current month-specific head circumference percentile can be obtained by looking up the table (as shown in Table A and Table B) through the postoperative head shape scan data and the patient's personal information. Since the child may have abnormal head circumference growth due to craniosynostosis, it is necessary to refer to the current month-specific percentile of other growth values ​​for correction, and estimate the head circumference and cranial brain volume growth during the treatment cycle. The duration of a single treatment cycle is recommended to be set between 1 and 6 months.

[0096] For example, the head circumference of an 8-month-old boy with sagittal synostosis was C 术后 The height is 47cm, the weight is 9.1kg, and the height is 71.7cm. The table shows that the postoperative head circumference percentile of the child is P97, the weight percentile is P50, and the height percentile is P50. It can be seen that the actual growth level of the child should be P50. Due to craniosynostosis and intracranial hematoma after surgery, the head circumference is abnormal. This abnormal condition will be improved in the later postoperative recovery and fixation process, and the head circumference percentile will return to its actual growth level, that is, P50. Therefore, the head circumference growth percentile of the child's current treatment course is corrected to P90. The table shows that the target head circumference C at 11 months of age is obtained. 目标 The head circumference C can be used to estimate the brain volume V of the child according to the following formula:

[0097]

[0098] From the postoperative scan model of the child, we can see that V 术后 The standard head shape C was obtained based on the postoperative scan head shape of the child, that is, the symptoms of craniosynostosis. 标准 =49cm, V 标准 =1350cc, and according to C 目标 V is 47.5cm and can be calculated by the above formula 目标 =1207.8cc. The standard head shape needs to be adjusted and the reserved space reduced so that the head circumference is 47.5±0.5cm and the cranial volume is 1207.8±80cc.

[0099] Table A: Percentile values ​​of weight for age of boys under 7 years old

[0100] The unit is kilogram

[0101] age <![CDATA[P3]]> <![CDATA[P 10 ]]> <![CDATA[P 25 ]]> <![CDATA[P 50 ]]> <![CDATA[P 75 ]]> <![CDATA[P 90 ]]> <![CDATA[P 97 ]]> 0 month 2.8 3.0 3.2 3.5 3.7 4.0 4.2 January 3.7 3.9 4.2 4.6 4.9 5.2 5.6 February 4.7 5.0 5.4 5.8 6.2 6.7 7.1 March 5.5 5.9 6.3 6.8 7.3 7.8 8.3 April 6.1 6.5 7.0 7.5 8.1 8.6 9.2 May 6.6 7.0 7.5 8.0 8.6 9.2 9.8 June 6.9 7.4 7.9 8.4 9.1 9.7 10.3 July 7.2 7.7 8.2 8.8 9.5 10.1 10.8 August 7.5 8.0 8.5 9.1 9.8 10.4 11.1 September 7.7 8.2 8.7 9.4 10.1 10.8 11.5 October 7.9 8.4 9.0 9.6 10.3 11.0 11.8 November 8.1 8.6 9.2 9.8 10.6 11.3 12.0 1 year old 8.2 8.8 9.4 10.1 10.8 11.5 12.3 1 year and 1 month 8.4 9.0 9.6 10.3 11.0 11.7 12.5 1 year and 2 months 8.6 9.2 9.7 10.5 11.2 12.0 12.8 1 year and 3 months 8.8 9.3 9.9 10.7 11.4 12.2 13.0 1 year and 4 months 9.0 9.5 10.1 10.9 11.7 12.4 13.3 1 year and 5 months 9.1 9.7 10.3 11.1 11.9 12.7 13.5 1 year and 6 months 9.3 9.9 10.5 11.3 12.1 12.9 13.8 1 year and 7 months 9.5 10.1 10.7 11.5 12.3 13.2 14.0 1 year and 8 months 9.7 10.3 10.9 11.7 12.6 13.4 14.3 1 year and 9 months 9.8 10.5 11.1 11.9 12.8 13.7 14.6

[0102] Table B Percentile values ​​of height / height for age of boys under 7 years old

[0103] Unit is cm

[0104] age <![CDATA[P3]]> <![CDATA[P 10 ]]> <![CDATA[P 25 ]]> <![CDATA[P 50 ]]> <![CDATA[P 75 ]]> <![CDATA[P 90 ]]> <![CDATA[P 97 ]]> 0 month 47.6 48.7 49.9 51.2 52.5 53.6 54.8 January 51.3 52.5 53.8 55.1 56.5 57.7 59.0 February 54.9 56.2 57.5 59.0 60.4 61.7 63.0 March 58.0 59.4 60.7 62.2 63.7 65.1 66.4 April 60.5 61.9 63.3 64.8 66.4 67.8 69.1 May 62.5 63.9 65.4 66.9 68.5 69.9 71.3 June 64.2 65.7 67.1 68.7 70.3 71.8 73.2 July 65.7 67.2 68.7 70.3 71.9 73.4 74.9 August 67.1 68.6 70.1 71.7 73.4 74.9 76.4 September 68.3 69.8 71.4 73.1 74.7 76.3 77.8 October 69.5 71.0 72.6 74.3 76.0 77.6 79.1 November 70.7 72.2 73.8 75.5 77.3 78.8 80.4 1 year old 71.7 73.3 74.9 76.7 78.5 80.1 81.6 1 year and 1 month 72.8 74.4 76.0 77.8 79.6 81.2 82.8 1 year and 2 months 73.8 75.4 77.1 78.9 80.7 82.4 84.0 1 year and 3 months 74.8 76.5 78.1 80.0 81.8 83.5 85.1

[0105] Operation S3 includes the following operations:

[0106] S31, using the obtained target head shape of the patient as the inner contour surface of the skull orthopedic fixator model, and performing an equal distance offset on the target head shape to obtain the outer contour surface of the skull orthopedic fixator. The distance between the outer contour surface and the inner contour surface is uniform (refer to Figure 9b As shown), the thickness of the skull orthopedic fixator can be stabilized in a relatively thin thickness range. The thickness of the fixator is recommended to be 0.2-4cm. The appearance of the skull orthopedic fixator is consistent with the curvature of the target head shape, and the shape may be an irregular curved surface;

[0107] Alternatively, the target head shape of the patient is used as the inner contour surface of the cranial orthopedic fixator model, and the outer contour surface of the cranial orthopedic fixator is obtained after an equidistant offset is performed on the standard head shape. The thickness of the cranial orthopedic fixator is different at different locations, and there may be a situation where some parts are thicker and some parts are thinner (see Fig.9c , 9d It is recommended that the thickness at the thinnest position should be no less than 0.2mm and the thickness at the thickest position should be no more than 4cm. The appearance of the fixator should be consistent with the curvature of the target head shape, and it should be relatively symmetrical, round and beautiful.

[0108] S32, establishing a skull orthopedic fixator model for the patient according to the inner contour surface and the outer contour surface, and making equal distance offsets to the target head shape or the standard head shape so that the skull orthopedic fixator has a certain thickness, thereby more safely protecting the skull of the patient.

[0109] In addition, local features corresponding to the patient need to be generated on the inner contour surface and the outer contour surface of the cranial orthopedic fixator model, and the local features include at least one of: a forehead area corresponding to the forehead of the patient, a front baffle corresponding to the front side of the patient's auricle, and a rear baffle corresponding to the rear side of the patient's auricle.

[0110] The height of the forehead area 21 is set to correspond to 0-5cm above the patient's eyebrows or cover the eyebrows; the width range of the front baffle 22 is 2-8cm, and the front baffle 22 is set to be 0.5-2cm away from the front point of the patient's auricle, and the width range of the rear baffle 23 is: 2-5cm and is set to cover the mastoid position behind the ear.

[0111] like Figure 8a As shown, in an exemplary embodiment, manufacturing the patient's cranial orthopedic fixture according to the generated cranial orthopedic fixture model of the patient in operation S4 includes:

[0112] S41, dividing the skull orthopedic fixator model into a first fixed shell 1 and a second fixed shell 2 which are spliced ​​to each other, wherein the splicing position of the first fixed shell 1 and the second fixed shell 2 does not include a skull growth constraint area, and / or includes a skull growth reserved space area or an area to be released during surgery.

[0113] The splicing position of the first fixed shell 1 and the second fixed shell 2 does not pass through the skull growth restriction zone to avoid reducing the restriction effect of the skull growth restriction zone. The splicing position of the first fixed shell 1 and the second fixed shell 2 passes through the skull growth reserved space area to further provide the skull with extension space.

[0114] In an exemplary embodiment, manufacturing the patient's cranial orthopedic fixture according to the generated cranial orthopedic fixture model of the patient in operation S4 includes:

[0115] S42. The skull orthopedic fixator model is formed in an integrated manner; the skull orthopedic fixator is designed to fully wrap the top of the skull; or, an opening 10 is set in the top area of ​​the skull of the skull orthopedic fixator model (see 8b), and the diameter of the opening 10 ranges from 5cm to 12cm to increase the breathability of the helmet.

[0116] Due to the developmental abnormalities caused by craniosynostosis, the skull to be corrected is usually accompanied by severe asymmetry, or abnormal protrusions and abnormal depressions. In order to maintain the stability of wearing the skull orthopedic fixator, the hole 10 should not be designed to be too large. The hole 10 is recommended to be designed within a circular area with a diameter of 5cm-12cm.

[0117] The skull orthopedic fixator model can adopt an integrated structure with a unilateral opening. The opening position is designed according to the postoperative head shape data and the target head shape. The opening can be flexibly connected by means of, for example, Velcro. An adjustable snap-on design can also be adopted. The opening position is the loosened side of the skull to be fixed during the skull surgery. A space for growth is provided through a unilateral opening. During the growth process, the size of the space for growth is adjusted by adjusting the connection.

[0118] In operation S4, the skull fixation of the patient is manufactured according to the generated skull orthopedic fixation device model of the patient, and further includes:

[0119] S43, setting a ventilation area on the cranial orthopedic fixator model, and setting ventilation holes on the ventilation area, and the ventilation area and the ventilation holes are set in at least one of the following ways:

[0120] The air permeable area includes the space reserved for skull growth of the cranial orthopedic fixator;

[0121] The air permeable area includes other areas except the skull growth restraint area of ​​the skull orthopedic fixator;

[0122] The ventilation area includes multiple ventilation sub-areas, and the sizes of multiple ventilation holes in the same ventilation sub-area are consistent, or the sizes of multiple ventilation holes in the same ventilation sub-area gradually change and the aperture of the ventilation holes gradually decreases from the central area close to the ventilation sub-area to the edge area close to the ventilation sub-area; the sizes of ventilation holes in different ventilation sub-areas are equal or unequal.

[0123] like Fig.11 As shown, an application example of the method for manufacturing a cranial orthopedic fixator according to an embodiment of the present application includes the following operation process:

[0124] Step 001, scan the infant's skull before surgery to obtain three-dimensional scanning data, or perform a CT scan on the infant before surgery to obtain CT data, and reconstruct the preoperative head shape through an algorithm.

[0125] Step 100, scanning the infant's skull after surgery, obtaining three-dimensional scanning data, and generating the current postoperative head shape;

[0126] Step 200, calculating and generating a corresponding standard head shape according to the obtained current head shape (post-operative head shape), and calculating a production target head shape according to the difference between the current head shape and the standard head shape;

[0127] Step 300, calculating and generating a fixator model according to the standard head shape and the target head shape, and obtaining a fixator by 3D printing;

[0128] Step 301, taking the target head shape as the inner contour surface and the target head shape as the outer contour surface by equal distance offset, calculating and producing a fixture model, and adopting 3D printing to obtain a fixture body.

[0129] Step 302, taking the target head shape as the inner contour surface and the standard head shape as the outer contour surface by equal distance offset, calculating and producing a fixator model, and using 3D printing to obtain a fixator body. Among them, step 301 and step 302 adopt one of them.

[0130] Step 400, adjusting the inner contour of the fixture to gradually approach the standard head shape.

[0131] like Fig.10a , 10b As shown, an embodiment of the present application provides a skull orthopedic fixator 100, which is manufactured using the skull orthopedic fixator manufacturing method of any of the above embodiments.

[0132] The skull orthopedic fixator 100 includes a fixed helmet body 1, which is provided with a skull growth reserved space area A and a skull growth constraint area B. The skull growth reserved space area A corresponds to the growth restricted side of the patient due to craniosynostosis, and the constrained area B corresponds to the compensatory growth area of ​​the patient caused by craniosynostosis.

[0133] like Fig.10b As shown, in an exemplary embodiment, the fixed helmet body 1 includes a first shell 11 and a second shell 12 spliced ​​to each other, and the splicing position of the first shell 11 and the second shell 12 passes through the skull growth reserved space area A and does not pass through the skull growth constraint area B. In another exemplary embodiment, the fixed helmet body 1 is made of one-piece molding.

[0134] In an exemplary embodiment, the fixed helmet body 1 is designed to fully cover the top of the skull. In another exemplary embodiment, an opening 10 is provided in the top of the skull (see Figure 8b As shown), the diameter range of the opening 10 is: 5cm-12cm, so as to increase the breathability of the helmet.

[0135] like Fig.10a As shown, the fixed helmet body 1 is provided with a plurality of ventilation holes 13 , the plurality of ventilation holes 13 include a plurality of ventilation holes 13 arranged in the pre-skull growth reserved space area A, and / or a plurality of ventilation holes 13 are not arranged in the skull growth constraint area B of the skull orthopedic fixator 100 .

[0136] like Fig.10b As shown, the fixed helmet body 1 includes an outer shell 101 and an inner shell 102 which is detachably mounted with the outer shell 101. The inner shell 102 is assembled with the outer shell 101 in a detachable manner, or the inner shell 102 is made of a material that can be processed and ground and cut secondary, so that the distance between the outer shell 101 and the inner shell 102 can be adjusted.

[0137] It will be appreciated by those skilled in the art that all or some of the steps, systems, and functional modules / units in the methods disclosed above may be implemented as software, firmware, hardware, and appropriate combinations thereof. In hardware implementations, the division between the functional modules / units mentioned in the above description does not necessarily correspond to the division of physical components; for example, a physical component may have multiple functions, or a function or step may be performed by several physical components in cooperation. Some or all components may be implemented as software executed by a processor, such as a digital signal processor or a microprocessor, or implemented as hardware, or implemented as an integrated circuit, such as an application-specific integrated circuit. Such software may be distributed on a computer-readable medium, which may include a computer storage medium (or non-transitory medium) and a communication medium (or temporary medium). As known to those skilled in the art, the term computer storage medium includes volatile and non-volatile, removable and non-removable media implemented in any method or technology for storing information (such as computer-readable instructions, data structures, program modules, or other data). Computer storage media include, but are not limited to, RAM, ROM, EEPROM, flash memory or other memory technology, CD-ROM, digital versatile disks (DVD) or other optical disk storage, magnetic cassettes, magnetic tapes, magnetic disk storage or other magnetic storage devices, or any other medium that can be used to store the desired information and can be accessed by a computer. In addition, it is well known to those of ordinary skill in the art that communication media typically contain computer-readable instructions, data structures, program modules, or other data in a modulated data signal such as a carrier wave or other transport mechanism, and may include any information delivery media.

Claims

1. A method for manufacturing a cranial orthopedic fixator, characterized in that: include: According to the patient's craniosynostosis symptoms and postoperative head shape, the patient's standard head shape was obtained; Obtaining a target head shape for the patient according to the obtained standard head shape for the patient and the skull growth parameters corresponding to the patient; Establishing a skull orthopedic fixator model for the patient according to the obtained target head shape of the patient; or establishing a skull orthopedic fixator model for the patient according to the obtained target head shape and standard head shape of the patient; The method of obtaining the standard head shape of the patient according to the symptoms of craniosynostosis and the postoperative head shape of the patient includes: According to the patient's craniosynostosis symptoms, select the corresponding standard head template; The selected standard head shape template is modified according to the postoperative head shape to obtain a standard head shape; The standard head shape includes a skull growth reserved space area and a skull growth constraint area, wherein the skull growth reserved space area is set to correspond to the growth restricted side of the patient due to craniosynostosis, and the skull growth constraint area is set to correspond to the compensatory growth area caused by craniosynostosis of the patient; The step of obtaining the target head shape of the patient according to the obtained standard head shape of the patient and the skull growth parameters corresponding to the patient includes: According to the first characteristic parameter of the patient, determining the percentile of the actual head circumference growth and development of the patient in the first head circumference percentile value list; According to the second characteristic parameter of the patient, determining the percentile of the reference head circumference growth and development corresponding to the patient in the second head circumference percentile value list; According to the determined actual head circumference growth percentile and the reference head circumference growth percentile, the target head circumference growth percentile of the patient is obtained; The target head shape is obtained according to the standard head shape and the obtained percentile of the target head circumference growth and development.

2. The method for manufacturing a cranial orthopedic fixator according to claim 1, characterized in that: The step of obtaining the target head shape according to the standard head shape and the target head circumference growth percentile includes: According to the percentile of the target head circumference growth and development, an estimated value of the skull growth parameter of the target head shape is obtained, wherein the skull growth parameter includes the head circumference and the cranial brain volume; Calculating the differences between the head circumference and cranial brain volume of the postoperative head shape and the head circumference and cranial brain volume of the standard head shape; The skull growth reserved space area of ​​the standard head shape is adjusted according to the calculated difference to obtain the target head shape, so that the head circumference and cranial brain volume values ​​of the target head shape match the estimated values ​​of the head circumference and cranial brain volume of the target head shape.

3. The method for manufacturing a cranial orthopedic fixator according to claim 1, characterized in that: The step of obtaining the target head circumference growth and development percentile of the patient according to the determined actual head circumference growth and development percentile and the reference head circumference growth and development percentile comprises: In the first head circumference percentile value list or the second head circumference percentile value list, a head circumference growth and development percentile between the actual head circumference growth and development percentile and the reference head circumference growth and development percentile is selected as the target head circumference growth and development percentile.

4. The method for manufacturing a cranial orthopedic fixator according to claim 1, characterized in that: The first characteristic parameters of the patient include age, gender and postoperative head circumference, and the second characteristic parameters of the patient include age, gender, height and weight.

5. The method for manufacturing a cranial orthopedic fixator according to any one of claims 1 to 4, characterized in that: The symptoms of craniosynostosis include one or more of: frontal suture synostosis, bilateral coronal suture synostosis, unilateral coronal suture synostosis, sagittal suture synostosis, and lambdoid suture synostosis.

6. The method for manufacturing a cranial orthopedic fixator according to any one of claims 1 to 4, characterized in that: Also includes: Using the obtained target head shape of the patient as the inner contour surface of the cranial orthopedic fixator model; The outer contour surface of the cranial orthopedic fixator model is obtained by performing an equidistant offset on the target head shape; or, the outer contour surface of the cranial orthopedic fixator model is obtained by performing an equidistant offset on the standard head shape.

7. The method for manufacturing a cranial orthopedic fixator according to claim 6, characterized in that: The method further comprises: A local feature corresponding to the patient is generated on the inner contour surface and the outer contour surface of the cranial orthopedic fixator model; the local feature includes at least one of the following: A frontal area corresponding to the forehead of the patient, a front baffle corresponding to the front side of the auricle of the patient, and a rear baffle corresponding to the rear side of the auricle of the patient.

8. The method for manufacturing a cranial orthopedic fixator according to claim 7, characterized in that: The height of the forehead area is set to correspond to 0-5cm above the patient's eyebrows or cover the eyebrow position; the width of the front baffle is in the range of 2-8cm, and the front baffle is set to be 0.5-2cm away from the front point of the patient's auricle; the width of the rear baffle is in the range of 2-5cm and is set to cover the patient's posterior mastoid position.

9. The method for manufacturing a cranial orthopedic fixator according to any one of claims 1 to 4, characterized in that: The cranial orthopedic fixator model is an integrally formed part; or The method also includes: dividing the skull orthopedic fixator model into a first fixed shell and a second fixed shell that are spliced ​​to each other, wherein the splicing position of the first fixed shell and the second fixed shell does not pass through the skull growth constraint area and / or passes through the skull growth reserved space area.

10. The method for manufacturing a cranial orthopedic fixator according to any one of claims 1 to 4, characterized in that: The skull top area of ​​the cranial orthopedic fixator model is a fully enclosed design; or The method further comprises: setting a hole in the skull top region of the skull orthopedic fixator model, wherein the diameter of the hole ranges from 5 cm to 12 cm.

11. The method for manufacturing a cranial orthopedic fixator according to any one of claims 1 to 4, characterized in that: The method further comprises: A ventilation area is provided on the cranial orthopedic fixator model, and ventilation holes are provided on the ventilation area. The ventilation area and the ventilation holes are set in at least one of the following ways: The air permeable area includes a space reserved for skull growth of the skull orthopedic fixator; The air permeable area includes other areas except the skull growth restriction area of ​​the skull orthopedic fixator; The breathable zone includes multiple breathable sub-regions, and the sizes of the multiple breathable holes in the same breathable sub-region are consistent, or the sizes of the multiple breathable holes in the same breathable sub-region gradually change and the aperture of the breathable holes gradually decreases from the central region close to the breathable sub-region to the edge region close to the breathable sub-region; the sizes of the breathable holes in different breathable sub-regions are equal or unequal.

12. The method for manufacturing a cranial orthopedic fixator according to any one of claims 1 to 4, characterized in that: The skull orthopedic fixator model is configured to include an outer shell and an inner shell arranged in the outer shell, the inner surface of the inner shell forms the inner contour surface of the skull orthopedic fixator model, and the outer surface of the outer shell forms the outer contour surface of the skull orthopedic fixator model.

13. A skull orthopedic fixator, characterized in that: include: The cranial orthopedic fixator is manufactured according to the manufacturing method of any one of claims 1 to 12.

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