技术领域technical field
本发明涉及医疗器材领域，具体涉及一种生产漏斗胸矫形板的方法。The invention relates to the field of medical equipment, in particular to a method for producing pectus excavatum orthopedic plates.
背景技术Background technique
漏斗胸（Pectus excavatum，简称PEX)是指构成前胸壁的胸骨、肋软骨及部分肋骨向脊柱方向凹陷呈漏斗状。它在前胸壁畸形中最为常见,约占前胸壁畸形的87%,其发病率为1/300~1/400,男女比例约为4:1。漏斗胸也是儿童最常见的胸壁畸形，其发病原因尚不明确，畸形的发展呈进行性加重，即胸骨的畸形程度随年龄增长而加重，可能逐步由对称性漏斗胸演变为不对称性漏斗胸，将导致胸腔容积减小,影响呼吸循环系统的功能，出现呼吸道感染，甚至可发展为阻塞性肺疾病，对儿童的生长发育及心理健康产生不良影响。Pectus excavatum (PEX for short) refers to the funnel-shaped depression of the sternum, costal cartilage and some ribs that make up the anterior chest wall toward the spine. It is the most common anterior chest wall deformity, accounting for about 87% of anterior chest wall deformities, its incidence rate is 1/300~1/400, and the ratio of male to female is about 4:1. Pectus excavatum is also the most common chest wall deformity in children. The cause of the disease is still unclear. The development of the deformity is progressive, that is, the degree of deformity of the sternum increases with age, and it may gradually evolve from symmetrical pectus excavatum to asymmetric pectus pectus excavatum. , will lead to a decrease in chest volume, affect the function of the respiratory and circulatory system, cause respiratory infections, and even develop into obstructive pulmonary disease, which will have adverse effects on children's growth and mental health.
1998年NUSS等人开创了微创漏斗胸矫形(Minimally invasive repair of pectus excavatum,简称MIRPE),又称NUSS手术,漏斗胸的治疗进入了微创时代。该手术方法是在胸骨下置入尺寸合适的金属矫形器使胸骨抬高,无需切除前胸壁的软骨,金属矫形器在体内保留2~3年后取出。相比之前的胸骨上举术、胸骨翻转术等创伤大,出血量多,术后恢复慢,远期复发率高的传统方法，NUSS手术具有切口位于胸部两侧,美容效果好；无须切断肋骨,组织创伤减少；患儿术后不必长时间卧床,恢复快等诸多优势。因此，目前NUSS手术已经广泛应用于临床。In 1998, Nuss and others created the minimally invasive repair of pectus excavatum (MIRPE for short), also known as NUSS surgery, and the treatment of pectus excavatum entered the minimally invasive era. This surgical method is to insert a metal orthosis of appropriate size under the sternum to elevate the sternum without removing the cartilage of the anterior chest wall. The metal orthosis is retained in the body for 2 to 3 years and then removed. Compared with the previous traditional methods such as sternal lift and sternal reversal, which have large trauma, heavy bleeding, slow postoperative recovery, and high long-term recurrence rate, NUSS surgery has incisions on both sides of the chest, and the cosmetic effect is good; there is no need to cut ribs , Tissue trauma is reduced; children do not have to stay in bed for a long time after surgery, recover quickly and many other advantages. Therefore, the NUSS operation has been widely used clinically.
但是我们也注意到在当前NUSS手术中存在一些不足，比如：手术切口的具体位置，金属矫形器即钢板的形状、固定方式等仅由医师凭临床经验确定,没有精确的仿真实验和力学分析进行辅助。这造成了手术效果很大程度上取决于医师的主观判断，会出现在手术中反复调整钢板形状的情况，延长了手术时间；同时，钢板多次穿进穿出病人胸腔也增加了对病人产生伤害的可能性。因此，有必要提出一种矫形板的个性化设计及生产方法，以解决上述问题。However, we have also noticed that there are some deficiencies in the current NUSS surgery, such as: the specific position of the surgical incision, the shape of the metal orthosis, that is, the shape of the steel plate, and the fixing method are only determined by the doctor based on clinical experience, without accurate simulation experiments and mechanical analysis. auxiliary. This has caused the effect of the operation to a large extent to depend on the subjective judgment of the doctor, and the shape of the steel plate will be adjusted repeatedly during the operation, which prolongs the operation time; possibility of injury. Therefore, it is necessary to propose a personalized design and production method of orthopedic plates to solve the above problems.
发明内容Contents of the invention
为解决上述问题，本发明提供一种生产漏斗胸矫形板的方法，以胸部CT扫描数据为基础，通过重建胸骨架三维模型设计矫形板的三维模型，利用有限元分析等分析手段分析矫形板置入胸腔后胸廓的恢复情况，从而确定矫形板在胸腔中的入点和出点、矫形板的几何参数。In order to solve the above problems, the present invention provides a method for producing pectus pectus orthopedic plate, based on chest CT scan data, the three-dimensional model of the orthopedic plate is designed by reconstructing the three-dimensional model of the thoracic skeleton, and the orthopedic plate is analyzed by means of analysis such as finite element analysis. The recovery of the thorax after entering the thoracic cavity, so as to determine the entry point and exit point of the orthopedic plate in the thoracic cavity, and the geometric parameters of the orthopedic plate.
本发明采用的技术方案如下所述：The technical scheme that the present invention adopts is as follows:
一种生产漏斗胸矫形板的方法，该方法根据漏斗胸病人的胸部CT图像，利用三维软件重建胸骨架3D模型，参考具有相近胸廓尺寸的正常人胸廓模型及其曲率变换设计矫形板的3D模型，利用有限元软件，分析漏斗胸病人胸骨架置入矫形板之后胸腔的矫正形状，与正常人胸廓相比，判断矫形板是否满足要求，如果是则确定矫形板的设计参数，并利用3D打印技术根据矫形板的三维模型进行生产；否则重新设计矫形板的3D模型。A method for producing a pectus excavatum orthopedic plate, the method uses three-dimensional software to reconstruct a 3D model of the thoracic skeleton according to the chest CT image of a pectus excavatum patient, and designs the 3D model of the orthopedic plate with reference to a normal human chest model with similar thoracic dimensions and its curvature transformation , using finite element software to analyze the corrected shape of the thoracic cavity of pectus pectus patients after the thoracic skeleton is placed in the orthopedic plate, compared with the normal thorax to judge whether the orthopedic plate meets the requirements, if so, determine the design parameters of the orthopedic plate, and use 3D printing Technology produces from the 3D model of the orthopedic plate; otherwise redesigns the 3D model of the orthopedic plate.
进一步地，所述生产漏斗胸矫形板的方法具体包括如下步骤：Further, the method for producing a pectus excavatum orthopedic plate specifically includes the following steps:
a) 建立正常人胸廓模型数据库，包含基于CT图像的胸廓三维模型，胸廓Haller指数，以及年龄性别人种的基本信息；a) Establish a normal human thorax model database, including the 3D thorax model based on CT images, the Haller index of the thorax, and the basic information of age, sex, and race;
b) 漏斗胸病人胸部进行CT扫描，得到完整的CT图像；b) CT scanning of the chest of patients with pectus pectus excavatum to obtain a complete CT image;
c) 利用三维软件，根据CT图像，提取并重建胸骨架三维模型；c) Utilize 3D software to extract and reconstruct the 3D model of the thoracic skeleton according to the CT images;
d) 根据漏斗胸病人的年龄、胸廓尺寸信息，从正常人胸廓模型数据库中选择与病人胸廓相近的正常人胸廓模型；d) According to the age and chest size information of the pectus pectus excavatum patient, select a normal human chest model similar to the patient's chest from the normal human chest model database;
e) 以正常人胸廓模型为参考，初步确定矫形板的数量以及矫形板在胸廓的置入点位置；e) Using the normal human thoracic model as a reference, preliminarily determine the number of orthopedic plates and the placement point of the orthopedic plates in the thorax;
f) 以正常人胸廓模型为参考，基于胸廓在胸骨架置入点横截面的胸腔内侧壁曲率变换趋势设计矫形板三维模型；f) Taking the normal human thoracic model as a reference, design the three-dimensional model of the orthopedic plate based on the curvature transformation trend of the inner thoracic wall of the thorax at the insertion point of the thoracic skeleton;
g) 根据漏斗胸病人的年龄和胸廓尺寸信息因素，确定胸腔骨架各部位的骨骼物理参数；确定矫形板的物理参数；利用有限元分析方法或者软件，分析胸骨架在置入矫形板之后胸腔的矫正形状；g) Determine the bone physical parameters of each part of the thoracic skeleton according to the age of the pectus excavatum patient and the thoracic size information factors; determine the physical parameters of the orthopedic plate; use the finite element analysis method or software to analyze the thoracic cavity after the thoracic skeleton is placed in the orthopedic plate Correct the shape;
h) 有限元分析结果与步骤d)所确定的正常人胸廓相比，判断矫形结果是否满足要求；如果满足要求，则确定矫形板三维模型以及确定矫形板在胸腔的置入点位置；否则，返回步骤f)，重新设计矫形板形状或者重新确定矫形板的置入位置，重新分析设计及分析，最终确定矫形板的设计模型以及确定置入点的位置。h) Comparing the finite element analysis result with the normal human thorax determined in step d), it is judged whether the orthopedic results meet the requirements; if the requirements are met, then determine the three-dimensional model of the orthopedic plate and determine the position of the orthopedic plate in the thoracic cavity; otherwise, Return to step f), redesign the shape of the orthopedic plate or re-determine the placement position of the orthopedic plate, re-analyze the design and analysis, and finally determine the design model of the orthopedic plate and determine the position of the placement point.
进一步地，步骤h)中对矫形结果的判断，还能通过胸廓多个水平截面的Haller指数与步骤d)中所选定的正常人胸廓Haller指数相比较。Further, the judgment of the orthopedic result in step h) can also be compared with the Haller index of the normal person's thorax selected in step d) through the Haller index of multiple horizontal sections of the thorax.
进一步地，步骤f）所建立的矫形板三维模型，其形状变化、长度、厚度、高度，与病人胸廓尺寸、年龄特征有密切相关；上述的矫形板三维模型形状变化、长度、厚度、高度，将根据步骤g)和h)的分析和判断结果进行调整。Further, the shape change, length, thickness, and height of the three-dimensional model of the orthopedic plate established in step f) are closely related to the chest size and age characteristics of the patient; the shape change, length, thickness, and height of the above-mentioned three-dimensional model of the orthopedic plate, Adjustments will be made according to the analysis and judgment results of steps g) and h).
进一步地，步骤g）中的基于有限元方法的矫形板矫形分析，还需要在有限元分析法或软件中对置入矫形板的胸廓施加外部力，分析置入矫形板后胸廓可以承受的重量。Further, in the orthopedic analysis of the orthopedic plate based on the finite element method in step g), it is also necessary to apply an external force to the thorax with the orthopedic plate in the finite element analysis method or software, and analyze the weight that the thorax can bear after the orthopedic plate is placed. .
进一步地，矫形板的三维模型，在满足胸腔矫形及外部受力要求的条件下，还对矫形板的尺寸和重量进行最优化，其目标是降低矫形板的整体重量。Furthermore, the three-dimensional model of the orthopedic plate optimizes the size and weight of the orthopedic plate while meeting the requirements of chest cavity correction and external force, with the goal of reducing the overall weight of the orthopedic plate.
相对于现有技术，本发明具有以下优点：Compared with the prior art, the present invention has the following advantages:
本发明一种生产漏斗胸矫形板的方法，能够根据漏斗胸病人的胸骨架形状，个性化设计矫形板的形状及尺寸，并通过有限元方法获得最优的矫形板参数。根据个性化设计模型而制作的矫形板，可有效避免了反复调整钢板形状给患者带来的伤害，有利于缩短手术时间，降低手术创伤和术中、术后出血量，保证术后的矫正效果。The invention discloses a method for producing pectus excavatum orthopedic plates, which can individually design the shape and size of the orthopedic plate according to the shape of the pectoral skeleton of the pectus excavatum patient, and obtain the optimal orthopedic plate parameters through the finite element method. The orthopedic plate made according to the personalized design model can effectively avoid the injury caused by repeated adjustment of the shape of the plate, which is conducive to shortening the operation time, reducing surgical trauma and intraoperative and postoperative blood loss, and ensuring the postoperative correction effect .
附图说明Description of drawings
图1是实施例中一种生产漏斗胸矫形板的方法的流程图。Fig. 1 is a flow chart of a method for producing a pectus excavatum orthopedic plate in an embodiment.
具体实施方式detailed description
下面将结合具体实施例对本发明作进一步说明，但不限于此，需指出的是，以下若有未特别详细说明之过程或参数，均是本领域技术人员可参照现有技术实现或理解的。The present invention will be further described below in conjunction with specific embodiments, but is not limited thereto. It should be noted that, if there are any processes or parameters that are not specifically described in detail below, those skilled in the art can realize or understand with reference to the prior art.
一种漏斗胸个性化治疗中矫形板的设计方法，根据漏斗胸病人的胸部CT图像，利用Mimics和Solidworks等三维软件重建胸骨架3D模型，参考具有相近胸廓尺寸的正常人胸廓模型及其曲率变换设计矫形板的3D模型，利用有限元软件，分析漏斗胸病人胸骨架置入矫形板之后胸腔的矫正形状，与正常人胸廓相比，判断矫形板是否满足要求，如果是则可以确定矫形板的设计参数，否则重新设计矫形板的3D模型并进一步分析。具体的设计步骤如下：A design method of orthopedic plate in the personalized treatment of pectus pectus excavatum. According to the chest CT image of the pectus excavatum patient, the 3D model of the chest skeleton is reconstructed by using Mimics and Solidworks and other 3D software, referring to the normal human chest model with similar chest size and its curvature transformation Design the 3D model of the orthopedic plate, and use the finite element software to analyze the corrected shape of the chest cavity of the pectus excavatum patient after the thoracic skeleton is placed in the orthopedic plate, and compare it with the normal thorax to determine whether the orthopedic plate meets the requirements. Design parameters, otherwise redesign the 3D model of the orthopedic plate and analyze further. The specific design steps are as follows:
a) 建立正常人胸廓模型数据库，包含基于CT图像的胸廓三维模型，胸廓Haller指数，以及年龄性别人种等基本信息；a) Establish a normal human thorax model database, including basic information such as the 3D thorax model based on CT images, the Haller index of the thorax, and age, sex, and race;
b) 漏斗胸病人胸部进行CT扫描，得到完整的CT图像；b) CT scanning of the chest of patients with pectus pectus excavatum to obtain a complete CT image;
c) 利用三维软件，根据CT图像，提取并重建胸骨架三维模型；c) Utilize 3D software to extract and reconstruct the 3D model of the thoracic skeleton according to the CT images;
d) 根据漏斗胸病人的年龄、胸廓尺寸等信息，从正常人胸廓模型数据库中选择与病人胸廓相近的正常人胸廓模型；d) Select a normal human thorax model similar to the patient's thorax from the normal human thorax model database according to the age and thorax size of the pectus excavatum patient;
e) 以正常人胸廓模型为参考，初步确定矫形板的数量以及矫形板在胸廓的置入点位置；e) Using the normal human thoracic model as a reference, preliminarily determine the number of orthopedic plates and the placement point of the orthopedic plates in the thorax;
f) 以正常人胸廓模型为参考，在与步骤e) 相同的置入点位置所在的横截面上，分析在该横截面上胸腔内壁的曲线形状，分析其曲率变化趋势，并以此作为矫形板的设计参考。在步骤e)的置入点位置，建立胸腔横截面，根据该胸腔横截面的尺寸，以上述建立的正常人曲线为依据，设计矫形板的尺寸外形。f) Using the normal human thorax model as a reference, analyze the curve shape of the inner wall of the thoracic cavity on the cross-section at the same cross-section as in step e), and analyze its curvature change trend, and use this as an orthopedic board design reference. At the position of the insertion point in step e), a cross-section of the chest cavity is established, and the size and shape of the orthopedic plate are designed according to the size of the cross-section of the chest cavity and the normal curve established above.
g) 根据漏斗胸病人的年龄等因素，确定胸腔骨架各部位的骨骼物理参数，主要有骨骼的密度分布、杨氏模量、泊松比；确定矫形板的物理参数；利用有限元分析方法或者软件，分析胸骨架在置入矫形板之后胸腔的矫正形状；g) According to factors such as the age of the pectus excavatum patient, determine the bone physical parameters of each part of the thoracic skeleton, mainly including bone density distribution, Young's modulus, and Poisson's ratio; determine the physical parameters of the orthopedic plate; use finite element analysis methods or Software to analyze the corrected shape of the thoracic cavity after the thoracic skeleton is placed in the orthopedic plate;
h) 有限元分析结果与步骤d)所确定的正常人胸廓相比，判断矫形结果是否满足要求；如果满足要求，则确定矫形板三维模型以及确定矫形板在胸腔的置入点位置；否则，重新设计矫形板形状或者重新确定矫形板的置入位置，重新分析设计及分析，最终确定矫形板的设计模型以及确定置入点的位置。h) Comparing the finite element analysis result with the normal human thorax determined in step d), it is judged whether the orthopedic results meet the requirements; if the requirements are met, then determine the three-dimensional model of the orthopedic plate and determine the position of the orthopedic plate in the thoracic cavity; otherwise, Redesign the shape of the orthopedic plate or re-determine the placement position of the orthopedic plate, re-analyze the design and analysis, and finally determine the design model of the orthopedic plate and determine the location of the placement point.
进一步地，步骤h)中对矫形结果的判断，还可以通过胸廓多个水平截面的Haller指数与步骤d)中所选定的正常人胸廓Haller指数相比较。Further, in the judgment of the orthopedic result in step h), the Haller index of multiple horizontal sections of the thorax can also be compared with the Haller index of the thorax of a normal person selected in step d).
进一步地，步骤f）所建立的矫形板三维模型，其形状变化、长度、厚度、高度等参数，与病人胸廓尺寸、年龄特征有密切相关；上述的矫形板三维模型各种参数，将根据步骤g)和h)的分析和判断结果进行调整。Further, the shape change, length, thickness, height and other parameters of the three-dimensional model of the orthopedic plate established in step f) are closely related to the chest size and age characteristics of the patient; various parameters of the three-dimensional model of the orthopedic plate mentioned above will be determined according to the steps The analysis and judgment results of g) and h) shall be adjusted.
进一步地，步骤g）中的基于有限元方法的矫形板矫形分析，还对置入矫形板的胸廓施加外部力。在有限元分析软件中，在胸腔模型外侧施加载荷，分析置入矫形板后胸廓可以承受的重量。Further, in the orthopedic analysis of the orthopedic plate based on the finite element method in step g), an external force is also applied to the thorax in which the orthopedic plate is placed. In the finite element analysis software, a load is applied to the outside of the chest model, and the weight that the chest can bear after the orthopedic plate is placed is analyzed.
进一步地，矫形板的三维模型，在满足胸腔矫形及外部受力要求的条件下，还需要对矫形板的尺寸和重量进行最优化，其目标是降低矫形板的整体重量。Furthermore, the three-dimensional model of the orthopedic plate needs to optimize the size and weight of the orthopedic plate under the condition of meeting the requirements of chest cavity correction and external force, and the goal is to reduce the overall weight of the orthopedic plate.
根据上述说明书的揭示和教导，本发明所属领域的技术人员还可以对上述实施方式进行变更和修改。因此，本发明并不局限于上面揭示和描述的具体实施方式，对本发明的一些修改和变更也应当落入本发明的权利要求的保护范围内。According to the disclosure and teaching of the above-mentioned specification, those skilled in the art to which the present invention belongs can also make changes and modifications to the above-mentioned embodiment. Therefore, the present invention is not limited to the specific embodiments disclosed and described above, and some modifications and changes to the present invention should also fall within the protection scope of the claims of the present invention.
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| RJ01 | Rejection of invention patent application after publication | Application publication date:20160928 |