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CN106388978A - Preparation method of acetabulum side model and guide plate based on three-dimensional reconstruction technology - Google Patents

Preparation method of acetabulum side model and guide plate based on three-dimensional reconstruction technology Download PDF

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CN106388978A
CN106388978A CN201610819251.1A CN201610819251A CN106388978A CN 106388978 A CN106388978 A CN 106388978A CN 201610819251 A CN201610819251 A CN 201610819251A CN 106388978 A CN106388978 A CN 106388978A
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model
guide plate
acetabular
dimensional
bone
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CN106388978B (en
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钟达
胡懿郃
王成功
廖前德
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Xiangya Hospital of Central South University
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2/32Joints for the hip
    • A61F2/34Acetabular cups
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2/3094Designing or manufacturing processes
    • A61F2/30942Designing or manufacturing processes for designing or making customized prostheses, e.g. using templates, CT or NMR scans, finite-element analysis or CAD-CAM techniques
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/28Bones
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2/32Joints for the hip
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2002/30001Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2/3094Designing or manufacturing processes
    • A61F2/30942Designing or manufacturing processes for designing or making customized prostheses, e.g. using templates, CT or NMR scans, finite-element analysis or CAD-CAM techniques
    • A61F2002/30948Designing or manufacturing processes for designing or making customized prostheses, e.g. using templates, CT or NMR scans, finite-element analysis or CAD-CAM techniques using computerized tomography, i.e. CT scans
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2/3094Designing or manufacturing processes
    • A61F2/30942Designing or manufacturing processes for designing or making customized prostheses, e.g. using templates, CT or NMR scans, finite-element analysis or CAD-CAM techniques
    • A61F2002/30952Designing or manufacturing processes for designing or making customized prostheses, e.g. using templates, CT or NMR scans, finite-element analysis or CAD-CAM techniques using CAD-CAM techniques or NC-techniques

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Abstract

一种基于三维重建技术的髋臼侧模型和导板的制备方法,步骤一、将患者术前的髋关节三维CT数据进行加工后建立数字化三维数据模型,重建髋臼侧三维骨性结构,还原疾病原始状态;步骤二、通过分析髋臼位置、评估髋臼状态、明确髋臼周围骨量和计算髋臼周围骨厚度,制定髋臼磨锉和髋臼螺钉置入方案,并对这些导板和模型进行三维建模;步骤三、使用3D打印机制作术前髋臼侧骨性模型、术中磨臼导板、术中髋臼螺钉导板和术后髋臼侧骨性模型;步骤四、上述导板和模型整合并检验,若不合格则重新设计,若合格则将导板和模型消毒后投入手术。

A preparation method of acetabular side model and guide plate based on 3D reconstruction technology, step 1, after processing the 3D CT data of the hip joint of the patient before operation, establish a digital 3D data model, reconstruct the 3D bony structure of the acetabular side, and restore the disease Original state; step 2, by analyzing the acetabular position, assessing the acetabular state, determining the bone volume around the acetabulum, and calculating the bone thickness around the acetabular area, formulate a plan for acetabular reaming and acetabular screw placement, and use these templates and models Carry out 3D modeling; step 3, use a 3D printer to make the preoperative acetabular side bone model, the intraoperative acetabular guide plate, the intraoperative acetabular screw guide plate, and the postoperative acetabular side bone model; step 4, integrate the above guide plate and model And check, if it is unqualified, it will be redesigned, if it is qualified, the guide plate and model will be sterilized and put into operation.

Description

一种基于三维重建技术的髋臼侧模型和导板的制备方法A preparation method of acetabular side model and guide plate based on three-dimensional reconstruction technology

技术领域technical field

本发明属于三维重建骨骼技术领域,涉及一种基于三维重建技术的髋臼侧模型和导板的制备方法。The invention belongs to the technical field of three-dimensional reconstruction of bones, and relates to a method for preparing an acetabular side model and a guide plate based on three-dimensional reconstruction technology.

背景技术Background technique

三维重建是指对三维物体建立适合计算机表示和处理的数学模型,是在计算机环境下对其进行处理、操作和分析其性质的基础,也是在计算机中建立表达客观世界的虚拟现实的关键技术。Three-dimensional reconstruction refers to the establishment of mathematical models suitable for computer representation and processing of three-dimensional objects.

人工关节置换术是指采用金属、高分子聚乙烯、陶瓷等材料,根据人体关节的形态、构造及功能制成人工关节假体,通过外科技术植入人体内,代替患病关节功能,达到缓解关节疼痛,恢复关节功能的目的。Artificial joint replacement refers to the use of metal, high molecular polyethylene, ceramics and other materials to make artificial joint prostheses according to the shape, structure and function of human joints, and implant them into the human body through surgical techniques to replace the function of diseased joints to achieve relief. Joint pain, the purpose of restoring joint function.

3D打印通常是采用数字技术材料打印机来实现的。常在模具制造、工业设计等领域被用于制造模型,后逐渐用于一些产品的直接制造,已经有使用这种技术打印而成的零部件。该技术在珠宝、鞋类、工业设计、建筑、工程和施工(AEC)、汽车,航空航天、牙科和医疗产业、教育、地理信息系统、土木工程、枪支以及其他领域都有所应用。3D printing is usually achieved using digital technology material printers. It is often used to make models in the fields of mold manufacturing and industrial design, and is gradually used in the direct manufacture of some products. There are already parts printed using this technology. The technology has applications in jewelry, footwear, industrial design, architecture, engineering and construction (AEC), automotive, aerospace, dental and medical industries, education, geographic information systems, civil engineering, firearms, and others.

目前,髋关节的疾病发病率很高,人工髋关节置换术仍然是目前最佳的治疗方法。At present, the incidence of diseases of the hip joint is very high, and artificial hip replacement is still the best treatment method at present.

但是,目前对于许多患者,尤其是髋关节畸形复杂、病情严重的患者,例如DDH;或者对于许多经验尚浅的关节科医生。在手术中往往遇到了许许多多的麻烦和难点:比如真臼确定,髋臼螺钉深度位置方向确定等,为手术带来了困难,且往往导致患者愈后较差。具体的问题如:手术时间长,如需要找真臼、确定髋臼位置、深度、角度,确定髋臼螺钉位置步骤过于繁琐。手术损伤大,需要反复磨臼、截骨等,导致出血量大等并发症。医生往往无法拟定精准个性化的手术方案。However, this is currently the case for many patients, especially those with complex, severe hip deformities such as DDH; or for many less experienced arthrologists. During the operation, many troubles and difficulties are often encountered: such as the determination of the true acetabulum, the determination of the depth, position and direction of the acetabular screw, etc., which bring difficulties to the operation and often lead to poor prognosis of the patient. Specific problems such as: the operation time is long, if it is necessary to find the real socket, determine the position, depth, angle of the acetabular, and determine the position of the acetabular screw is too cumbersome. Surgical injuries are large, requiring repeated grinding of sockets, osteotomies, etc., resulting in complications such as heavy bleeding. Doctors are often unable to formulate precise and individualized surgical plans.

复杂人工髋关节置换术(如DDH)的成功率不理想,高难度人工髋关节置换术的失败率较高,治疗效果不确切。成为了亟待解决的难题。The success rate of complex artificial hip replacement (such as DDH) is not ideal, and the failure rate of difficult artificial hip replacement is relatively high, and the treatment effect is uncertain. has become an urgent problem to be solved.

解决上述问题的关键有几点:1、客观全面正确的认识疾病的真实状态;2、为手术患者(特别是高难度手术患者)制定疗效确切、安全合理的个性化、精准手术方案;3、保证该方案的不打折扣的顺利实施。There are several key points to solve the above problems: 1. To understand the real state of the disease objectively, comprehensively and correctly; 2. To formulate a personalized and precise surgical plan with definite curative effect, safety and reasonableness for surgical patients (especially those with difficult surgery); 3. Ensure the smooth implementation of the program without compromise.

即便如此,上述方法还是需要靠经验十分丰富的专家通过反复分析论证后才能实现,并且效率和成功率堪忧。Even so, the above method still needs to be realized after repeated analysis and demonstration by experienced experts, and the efficiency and success rate are worrying.

因此,如何利用3D打印技术更好的为髋关节手术服务就显得尤为必要。Therefore, how to use 3D printing technology to better serve hip surgery is particularly necessary.

发明内容Contents of the invention

本发明的目的是提供一种基于三维重建技术的髋臼侧模型和导板的制备方法。解决了目前许多医生,尤其是针对髋关节畸形复杂、病情严重的患者,例如DDH在手术中真臼确定,髋臼螺钉的问题。The purpose of the present invention is to provide a method for preparing acetabular side model and guide plate based on three-dimensional reconstruction technology. It solves the problems that many doctors currently have, especially for patients with complex and serious hip joint deformities, such as DDH in determining the true socket and acetabular screws during surgery.

为达到上述目的,本发明的技术方案为:To achieve the above object, the technical solution of the present invention is:

一种基于三维重建技术的髋臼侧模型和导板的制备方法,包括如下步骤:A method for preparing an acetabular side model and guide plate based on three-dimensional reconstruction technology, comprising the following steps:

步骤一、将患者术前的髋关节三维CT数据进行加工后建立数字化三维数据模型,重建髋臼侧三维骨性结构,还原疾病原始状态。Step 1. After processing the preoperative 3D CT data of the hip joint, a digital 3D data model is established to reconstruct the 3D bony structure of the acetabular side and restore the original state of the disease.

其中,对髋关节三维CT数据进行加工后建立数字化三维数据模型的具体操作为:图像导入→阈值划分(特定组织提取)→三维重建模型生成→计算机辅助设计(测量、设计导板,钛板贴面,个性化植入物等)→3D打印;Among them, the specific operation of establishing a digital 3D data model after processing the 3D CT data of the hip joint is: image import→threshold division (specific tissue extraction)→3D reconstruction model generation→computer-aided design (measurement, design guide plate, titanium plate veneer) , personalized implants, etc.) → 3D printing;

具体如下:details as follows:

1)图像导入:1) Image import:

利用mimics和E-3D等三维重建软件,支持DICOM标准的薄层扫描图像。病人通过CT或者MRI检查后,可以导出此格式的图像;Using 3D reconstruction software such as mimics and E-3D, it supports DICOM standard thin-slice scanning images. After the patient has passed the CT or MRI examination, the image in this format can be exported;

2)阈值划分:2) Threshold division:

CT扫描图像的灰度值反应的是组织对于X线的不同衰减系数;阈值分割方法是基于灰度图像的一种计算操作,在设定阈值范围内的组织被保留,其他的被去除;The gray value of the CT scan image reflects the different attenuation coefficients of the tissue for X-rays; the threshold segmentation method is a calculation operation based on the gray image, and the tissues within the set threshold range are retained, while others are removed;

3)三维重建模型生成:3) 3D reconstruction model generation:

在MIMICS和E-3D软件中,则是通过三维基元的体数据来描述物体,通过CT等断层扫描设备得到病患的体数据后,通过阈值分割来得到物体的三维蒙板,基于三维蒙板计算三维模型的过程就是三维重建;In MIMICS and E-3D software, the object is described by the volume data of the three-dimensional primitive. After obtaining the volume data of the patient through CT and other tomography equipment, the three-dimensional mask of the object is obtained through threshold segmentation. Based on the three-dimensional mask The process of calculating the 3D model of the board is 3D reconstruction;

4)计算机辅助设计:4) Computer aided design:

根据病患三维模型的实际情况,进行虚拟手术设计;通过CAD,3-matic,MAGICS等辅助工具或者软件设计出合适的导板或植入物等,参与到手术过程,辅助医生进行手术;According to the actual situation of the patient's three-dimensional model, virtual surgery design is carried out; through CAD, 3-matic, MAGICS and other auxiliary tools or software, suitable guide plates or implants are designed to participate in the operation process and assist doctors in the operation;

5)3D打印:5) 3D printing:

3D打印技术也叫增量制造,指由数字模型直接驱动的,运用金属、塑料、陶瓷、树脂、蜡、纸、砂等可粘合材料,在快速成形设备里通过逐层叠加的方式来构造物理实体的技术;把三维重建好的病患模型以及设计好的导板模型放入快速成型设备,最终得到1:1的实体;3D printing technology is also called incremental manufacturing, which refers to the direct drive of digital models, using metal, plastic, ceramics, resin, wax, paper, sand and other bondable materials to construct by layer-by-layer in rapid prototyping equipment Physical entity technology; put the 3D reconstructed patient model and the designed guide plate model into the rapid prototyping equipment, and finally get a 1:1 entity;

步骤二、通过分析髋臼位置、评估髋臼状态、明确髋臼周围骨量和计算髋臼周围骨厚度,制定髋臼磨锉和髋臼螺钉置入方案,并对这些导板和模型进行三维建模;Step 2. By analyzing the position of the acetabulum, assessing the state of the acetabulum, determining the amount of bone around the acetabulum, and calculating the thickness of the bone around the acetabulum, formulate a plan for acetabular reaming and acetabular screw placement, and perform three-dimensional modeling of these guide plates and models. mold;

其中,骨量测量:Among them, bone mass measurement:

因三维重建后的数字模型在阈值分割时,有部分骨松质没有提取,因而最终得出的三维模型会有很多空洞;通过三维软件对模型进行修复,补洞后可以选择需要测量的地方测量三维模型的体积,从而得出骨量;Part of the spongy bone was not extracted during the threshold segmentation of the 3D reconstructed digital model, so the final 3D model will have many cavities; the model is repaired by 3D software, and after filling the holes, you can choose the place to be measured for measurement The volume of the 3D model to derive the bone mass;

骨厚度测量bone thickness measurement

通过MAGICS等三维软件,直接选择模型的前后壁的两个点,两点之间的距离就是骨厚度;Through 3D software such as MAGICS, directly select two points on the front and rear walls of the model, and the distance between the two points is the bone thickness;

步骤三、使用3D打印机制作术前髋臼侧骨性模型、术中磨臼导板、术中髋臼螺钉导板和术后髋臼侧骨性模型;Step 3. Use a 3D printer to make a preoperative acetabular bone model, an intraoperative grinding guide, an intraoperative acetabular screw guide, and a postoperative acetabular bone model;

其中,制作模型的材料采用医用高分子材料,具体为尼龙材料FS3200PAAmong them, the material for making the model is medical polymer material, specifically nylon material FS3200PA

步骤四、上述导板和模型整合并检验,若不合格则重新设计,若合格则将导板和模型消毒后投入手术;Step 4. The above-mentioned guide plate and model are integrated and inspected. If it is unqualified, it will be redesigned. If it is qualified, the guide plate and model will be sterilized and put into operation;

其中,具体的检验标准为:所有导板和模型在3D打印出来的第一时间将接受“产品与设计图是否吻合的检测”,采用人工判断,如果产品的形状、结构、质地等性状不合格,则进行再加工和改进,严重不合格者则调整设计参数后重新制作产品;Among them, the specific inspection standard is: all guide plates and models will be subject to "testing whether the product matches the design drawing" as soon as they are 3D printed. Manual judgment is used. If the shape, structure, texture and other properties of the product are unqualified, If it is seriously unqualified, it will adjust the design parameters and re-make the product;

将“术前髋臼侧骨性模型、术中磨臼导板、术中髋臼螺钉导板和术后髋臼侧骨性模型”依次进行手术模拟试验,观察各导板与各模型之间是否能正确顺畅地组合,如果有不顺利的情况,则再加工,或重新制作。The "preoperative acetabular side bone model, intraoperative grinding guide plate, intraoperative acetabular screw guide plate and postoperative acetabular side bone model" were performed in sequence to perform surgical simulation tests to observe whether the relationship between each guide plate and each model can be correct and smooth. If there is any unsatisfactory situation, reprocess or remake.

相对于现有技术,本发明的有益效果为:Compared with the prior art, the beneficial effects of the present invention are:

1.手术前能通过观察模型,最大限度还原疾病原始状态1. By observing the model before surgery, the original state of the disease can be restored to the greatest extent

2.手术前能通过观察模型和导板,将他们进行组合演练,为患者设计个性精准化手术方案2. By observing the model and the guide plate before the operation, they can be combined and practiced to design a personalized and precise surgical plan for the patient

3.手术中可以快速确定髋臼的定位、磨锉的大小、深度、角度等3. The position of the acetabulum, the size, depth and angle of the file can be quickly determined during the operation

4.手术中可以快速确定髋臼螺钉入钉位置、角度、长度等4. The position, angle and length of the acetabular screw can be quickly determined during the operation

5.实现精确手术方案、减少手术损伤、缩短手术时间、提高复杂人工髋关节置换术的成功率、降低高难度人工髋关节置换术的失败率。5. Realize accurate surgical plan, reduce surgical injury, shorten operation time, improve the success rate of complex artificial hip replacement, and reduce the failure rate of difficult artificial hip replacement.

附图说明Description of drawings

图1为本发明方法的流程示意框图。Fig. 1 is a schematic block diagram of the process of the method of the present invention.

图2为本发明试验例中磨臼导板、髋臼螺钉导板与术后(磨臼后)骨性模型的结合的模型图。Fig. 2 is a model diagram of the combination of the acetabular guide plate, the acetabular screw guide plate and the postoperative (after the acetabular) bone model in the test example of the present invention.

具体实施方式detailed description

下面结合附图和具体实施方式对本发明技术方案做进一步详细描述:The technical solution of the present invention will be further described in detail below in conjunction with the accompanying drawings and specific embodiments:

如图1所示,一种基于三维重建技术的髋臼侧模型和导板的制备方法,包括如下步骤:As shown in Figure 1, a preparation method of acetabular side model and guide plate based on three-dimensional reconstruction technology includes the following steps:

步骤一、将患者术前的髋关节三维CT数据进行加工后建立数字化三维数据模型,重建髋臼侧三维骨性结构,还原疾病原始状态。Step 1. After processing the preoperative 3D CT data of the hip joint, a digital 3D data model is established to reconstruct the 3D bony structure of the acetabular side and restore the original state of the disease.

其中,对髋关节三维CT数据进行加工后建立数字化三维数据模型的具体操作为:图像导入→阈值划分(特定组织提取)→三维重建模型生成→计算机辅助设计(测量、设计导板,钛板贴面,个性化植入物等)→3D打印;Among them, the specific operation of establishing a digital 3D data model after processing the 3D CT data of the hip joint is: image import→threshold division (specific tissue extraction)→3D reconstruction model generation→computer-aided design (measurement, design guide plate, titanium plate veneer) , personalized implants, etc.) → 3D printing;

具体如下:details as follows:

6)图像导入:6) Image import:

利用mimics和E-3D等三维重建软件,支持DICOM标准的薄层扫描图像。病人通过CT或者MRI检查后,可以导出此格式的图像;Using 3D reconstruction software such as mimics and E-3D, it supports DICOM standard thin-slice scanning images. After the patient has passed the CT or MRI examination, the image in this format can be exported;

7)阈值划分:7) Threshold division:

CT扫描图像的灰度值反应的是组织对于X线的不同衰减系数;阈值分割方法是基于灰度图像的一种计算操作,在设定阈值范围内的组织被保留,其他的被去除;The gray value of the CT scan image reflects the different attenuation coefficients of the tissue for X-rays; the threshold segmentation method is a calculation operation based on the gray image, and the tissues within the set threshold range are retained, while others are removed;

8)三维重建模型生成:8) 3D reconstruction model generation:

在MIMICS和E-3D软件中,则是通过三维基元的体数据来描述物体,通过CT等断层扫描设备得到病患的体数据后,通过阈值分割来得到物体的三维蒙板,基于三维蒙板计算三维模型的过程就是三维重建;In MIMICS and E-3D software, the object is described by the volume data of the three-dimensional primitive. After obtaining the volume data of the patient through CT and other tomography equipment, the three-dimensional mask of the object is obtained through threshold segmentation. Based on the three-dimensional mask The process of calculating the 3D model of the board is 3D reconstruction;

9)计算机辅助设计:9) Computer aided design:

根据病患三维模型的实际情况,进行虚拟手术设计;通过CAD,3-matic,MAGICS等辅助工具或者软件设计出合适的导板或植入物等,参与到手术过程,辅助医生进行手术;According to the actual situation of the patient's three-dimensional model, virtual surgery design is carried out; through CAD, 3-matic, MAGICS and other auxiliary tools or software, suitable guide plates or implants are designed to participate in the operation process and assist doctors in the operation;

10)3D打印:10) 3D printing:

3D打印技术也叫增量制造,指由数字模型直接驱动的,运用金属、塑料、陶瓷、树脂、蜡、纸、砂等可粘合材料,在快速成形设备里通过逐层叠加的方式来构造物理实体的技术;把三维重建好的病患模型以及设计好的导板模型放入快速成型设备,最终得到1:1的实体;3D printing technology is also called incremental manufacturing, which refers to the direct drive of digital models, using metal, plastic, ceramics, resin, wax, paper, sand and other bondable materials to construct by layer-by-layer in rapid prototyping equipment Physical entity technology; put the 3D reconstructed patient model and the designed guide plate model into the rapid prototyping equipment, and finally get a 1:1 entity;

步骤二、通过分析髋臼位置、评估髋臼状态、明确髋臼周围骨量和计算髋臼周围骨厚度,制定髋臼磨锉和髋臼螺钉置入方案,并对这些导板和模型进行三维建模;Step 2. By analyzing the position of the acetabulum, assessing the state of the acetabulum, determining the amount of bone around the acetabulum, and calculating the thickness of the bone around the acetabulum, formulate a plan for acetabular reaming and acetabular screw placement, and perform three-dimensional modeling of these guide plates and models. mold;

其中,骨量测量:Among them, bone mass measurement:

因三维重建后的数字模型在阈值分割时,有部分骨松质没有提取,因而最终得出的三维模型会有很多空洞;通过三维软件对模型进行修复,补洞后可以选择需要测量的地方测量三维模型的体积,从而得出骨量;Part of the spongy bone was not extracted during the threshold segmentation of the 3D reconstructed digital model, so the final 3D model will have many cavities; the model is repaired by 3D software, and after filling the holes, you can choose the place to be measured for measurement The volume of the 3D model to derive the bone mass;

骨厚度测量bone thickness measurement

通过MAGICS等三维软件,直接选择模型的前后壁的两个点,两点之间的距离就是骨厚度;Through 3D software such as MAGICS, directly select two points on the front and rear walls of the model, and the distance between the two points is the bone thickness;

步骤三、使用3D打印机制作术前髋臼侧骨性模型、术中磨臼导板、术中髋臼螺钉导板和术后髋臼侧骨性模型;Step 3. Use a 3D printer to make a preoperative acetabular bone model, an intraoperative grinding guide, an intraoperative acetabular screw guide, and a postoperative acetabular bone model;

其中,制作模型的材料采用医用高分子材料,具体为尼龙材料FS3200PAAmong them, the material for making the model is medical polymer material, specifically nylon material FS3200PA

步骤四、上述导板和模型整合并检验,若不合格则重新设计,若合格则将导板和模型消毒后投入手术;Step 4. The above-mentioned guide plate and model are integrated and inspected. If it is unqualified, it will be redesigned. If it is qualified, the guide plate and model will be sterilized and put into operation;

其中,具体的检验标准为:所有导板和模型在3D打印出来的第一时间将接受“产品与设计图是否吻合的检测”,采用人工判断,如果产品的形状、结构、质地等性状不合格,则进行再加工和改进,严重不合格者则调整设计参数后重新制作产品;Among them, the specific inspection standard is: all guide plates and models will be subject to "testing whether the product matches the design drawing" as soon as they are 3D printed. Manual judgment is used. If the shape, structure, texture and other properties of the product are unqualified, If it is seriously unqualified, it will adjust the design parameters and re-make the product;

将“术前髋臼侧骨性模型、术中磨臼导板、术中髋臼螺钉导板和术后髋臼侧骨性模型”依次进行手术模拟试验,观察各导板与各模型之间是否能正确顺畅地组合,如果有不顺利的情况,则再加工,或重新制作。The "preoperative acetabular side bone model, intraoperative grinding guide plate, intraoperative acetabular screw guide plate and postoperative acetabular side bone model" were performed in sequence to perform surgical simulation tests to observe whether the relationship between each guide plate and each model can be correct and smooth. If there is any unsatisfactory situation, reprocess or remake.

材质采用的是尼龙材料FS3200PAThe material is nylon material FS3200PA

拉伸强度:Tensile Strength:

48Mpa,完全满足打孔固定导板,辅助磨挫,切割,打孔等操作的强度要求。48Mpa, fully meet the strength requirements of drilling fixed guide plate, auxiliary grinding, cutting, drilling and other operations.

熔点:Melting point:

170,通过低温消毒跟环氧乙烷等消毒方式不会产生变形等问题。物理性质:170. There will be no deformation and other problems through low-temperature disinfection and ethylene oxide and other disinfection methods. Physical properties:

化学性质:Chemical properties:

学名聚十二内酰胺。一种热塑性树脂。密度1.01~1.04。熔点178~180℃。吸水率1.26%(在20℃水中)。耐稀酸,不耐浓酸。耐碱性很好。耐溶剂性较好。The scientific name is polylaurolactam. A thermoplastic resin. Density 1.01 ~ 1.04. The melting point is 178-180°C. Water absorption 1.26% (in water at 20°C). Resistant to dilute acid, not resistant to concentrated acid. Alkali resistance is very good. Good solvent resistance.

毒理学数据:Toxicological data:

1、急性毒性:小鼠腹膜腔LD50:100mg/kg;1. Acute toxicity: mouse peritoneal cavity LD50: 100mg/kg;

2、其他多剂量毒性:大鼠经口TDLo:2730mg/kg/13W-C;2. Other multi-dose toxicity: oral TDLo in rats: 2730mg/kg/13W-C;

3、生殖毒性:交配前42天的雄性大鼠经口TDLo:1260mg/kgSEX/DURATION;3. Reproductive toxicity: oral TDLo of male rats 42 days before mating: 1260mg/kgSEX/DURATION;

临床试验例:Examples of clinical trials:

步骤一step one

通过方位块与盆骨相交线确定盆骨的三维方向。The three-dimensional direction of the pelvis is determined by the intersection line of the orientation block and the pelvis.

步骤二,通过MIMICS软件,确定植入髋臼杯的大小与位置,得到虚拟髋臼杯中心的位置。Step 2: Determine the size and position of the implanted acetabular cup through MIMICS software, and obtain the position of the center of the virtual acetabular cup.

此病人最后选用52MM的髋臼杯The patient finally chose a 52MM acetabular cup

步骤三,得到髋臼杯中心线,通过虚拟股骨头中心,盆骨的三维方向垂直方向旋转45度,前倾15度。Step 3: Obtain the centerline of the acetabular cup, pass through the center of the virtual femoral head, rotate the three-dimensional direction of the pelvis vertically by 45 degrees, and tilt forward by 15 degrees.

步骤四、以髋臼杯中心做髋臼半径26MM加上20MM最短螺钉的长度,得到46mm的假想螺钉,螺钉漏出骨头的为非安全距离螺钉。Step 4: Make an acetabular radius of 26 mm from the center of the acetabular cup and add the length of the shortest screw of 20 mm to obtain an imaginary screw of 46 mm. The screw that leaks out of the bone is a non-safe distance screw.

步骤五,盆骨以52mm为直径,去掉多余骨头,做一个直径52mm的半圆球杯,并含限位标志。半球杯与可打螺钉相交位置为2CM螺钉的安全范围。Step 5: The diameter of the pelvis is 52mm, and the excess bone is removed to make a semicircular cup with a diameter of 52mm and a limit mark. The intersection position between the hemispherical cup and the driveable screw is the safe range of 2CM screw.

步骤六,在限位标志处选择贴合面,在术中贴合骨面,从而固定半球杯的位置。Step 6: Select the fitting surface at the limit mark, and fit the bone surface during the operation to fix the position of the hemispherical cup.

步骤七step seven

通过贴合面导板上平行髋臼杯中心线做根圆棒,术中可以插入克氏针,指导磨骨的方向。A round rod is made parallel to the centerline of the acetabular cup on the fitting surface guide, and a Kirschner wire can be inserted during the operation to guide the direction of the bone grinding.

步骤八step eight

在贴合导板上左平行半球杯的外弧限位环,确定磨骨的方向以及深度。On the outer arc limit ring of the left parallel hemispherical cup on the fitting guide plate, determine the direction and depth of bone grinding.

上述设计完善后开始打印产品(模型+导板)最终产品如图2所示。After the above design is completed, start to print the product (model + guide plate). The final product is shown in Figure 2.

手术Operation

任意髋关节常规入路→暴露髋臼上缘区域→寻找术前计划的骨性标志→安装磨臼导板→磨臼→安装髋臼螺钉导板并标记→检查→置入臼杯产品→置入髋臼螺钉→后续步骤与常规手术步骤相同Conventional approach to any hip joint→expose the upper border of the acetabulum→find the bony landmarks planned before operation→install the acetabular guide plate→grind the acetabulum→install the acetabular screw guide plate and mark it→check→place the acetabular cup product→place the acetabular screw → Subsequent steps are the same as conventional surgery steps

表1:“本方法”相比“导航技术”的优势:Table 1: Advantages of "this method" compared with "navigation technology":

表2:“本方法”相比“单纯3D打印”的优势(目前已有许多三维重建后3D打印出骨性模型的报道):Table 2: Advantages of "this method" over "pure 3D printing" (currently there are many reports on 3D printing of bone models after 3D reconstruction):

以上所述,仅为本发明的具体实施方式,但本发明的保护范围并不局限于此,任何不经过创造性劳动想到的变化或替换,都应涵盖在本发明的保护范围之内。因此,本发明的保护范围应该以权利要求书所限定的保护范围为准。The above is only a specific implementation of the present invention, but the scope of protection of the present invention is not limited thereto, and any changes or replacements that do not come to mind through creative work shall be covered within the scope of protection of the present invention. Therefore, the protection scope of the present invention should be determined by the protection scope defined in the claims.

Claims (4)

1. the preparation method of a kind of acetabular bone side form type based on three-dimensional reconstruction and guide plate is it is characterised in that include following walking Suddenly:
Step one, the hip joint three dimensional CT data before operation in patients is processed after set up Digital Three-Dimensional data model, rebuild Acetabular bone side three-dimensional bony structure, reduces disease reset condition;
Wherein, the concrete operations setting up Digital Three-Dimensional data model after hip joint three dimensional CT data being processed are:Image Importing → threshold value division → Three-dimension Reconstruction Model generation → CAD → 3D printing;
Step 2, by analyzing acetabular bone position, assessment acetabular bone state, clear and definite Periacetabular bone amount and to calculate Periacetabular bone thick Degree, formulates acetabular bone burr and scheme inserted by acetabular bone screw, and carries out three-dimensional modeling to these guide plates and model;
Step 3, made using 3D printer preoperative acetabular bone side seam model, grinding mortar guide plate in art, in art acetabular bone screw guide plate and Postoperative acetabular bone side seam model;
Wherein, the material making model adopts medical macromolecular materials, specially nylon material FS3200PA;
Step 4, above-mentioned guide plate and model integration are simultaneously checked, if unqualified, redesign, if qualified, guide plate and model are disappeared Operation is put into after poison.
2. according to claim 1 a kind of based on the acetabular bone side form type of three-dimensional reconstruction with the preparation method of guide plate, its It is characterised by, in described step one, after hip joint three dimensional CT data is processed, set up the tool of Digital Three-Dimensional data model Gymnastics is made to comprise the steps:
1) image imports:
Support the three-dimensional reconstruction software of the thin layer scanning image of dicom standard using mimics and E-3D;By patient pass through CT or View data after person MRI inspection, exports as the image of DICOM format;
2) threshold value divides:
The gray value reaction of CT scan image is the differential declines coefficient for x-ray for the tissue;Threshold segmentation method is based on ash The a kind of of degree image calculates operation, and the tissue in the range of given threshold is retained, and others are removed;
3) Three-dimension Reconstruction Model generates:
In MIMICS and E-3D software, then it is object to be described by the volume data of three-dimensional primitive, by tomoscans such as CT After equipment obtains the volume data of sufferer, obtain the three-dimensional mask of object by Threshold segmentation, calculated based on three-dimensional mask three-dimensional The process of model is exactly three-dimensional reconstruction;
4) CAD:
According to the actual conditions of sufferer threedimensional model, carry out virtual operation design;By CAD, 3-matic, MAGICS etc. assist Instrument or Software for Design go out suitable guide plate or implant etc., participate in surgical procedure, and auxiliary doctor is performed the operation;
5) 3D printing:
3D printing technique is also named increment manufacture, refers to be directly driven by mathematical model, with metal, plastics, pottery, resin, wax, Paper, sand etc. can jointing material, carry out the technology of structural physical entity in quickly shaping device by way of being successively superimposed;Three Rapid forming equipment put into by the dimension sufferer model rebuild and the guide plate model designing, and finally gives 1:1 entity.
3. according to claim 1 a kind of based on the acetabular bone side form type of three-dimensional reconstruction with the preparation method of guide plate, its It is characterised by, in described step 2, the concrete measuring method of bone amount and bone thickness is:
Because the mathematical model after three-dimensional reconstruction is in Threshold segmentation, part cancellous bone is had not extract, thus finally draw three Dimension module has a lot of cavities;By three-dimensional software, model is repaired, after filling-up hole, can select to need the local survey of measurement The volume of amount threedimensional model, thus draw bone amount;
By three-dimensional softwares such as MAGICS, directly select two points of the front and rear wall of model, be exactly that bone is thick at the distance between 2 points Degree.
4. according to claim 1 a kind of based on the acetabular bone side form type of three-dimensional reconstruction with the preparation method of guide plate, its It is characterised by, in described step 4, specific test stone is:The very first time out will in 3D printing for all guide plates and model Accept " detection whether product and design drawing coincide ", using artificial judgment, the such as proterties such as the shape of fruit product, structure, quality Unqualified, then reprocessed and improved, serious failure is then remake product after adjusted design parameter;
Will " acetabular bone screw guide plate and postoperative acetabular bone side seam model in grinding mortar guide plate in preoperative acetabular bone side seam model, art, art " Carry out surgical simulation test successively, observe and whether can correctly swimmingly combine, if there are not smooth between each guide plate and each model Situation, then reprocess, or remake.
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CN112451090B (en) * 2019-11-06 2022-02-18 中国人民解放军总医院第四医学中心 Construction system of analysis model
CN110974490A (en) * 2019-11-28 2020-04-10 佛山市逸合生物科技有限公司 Manufacturing method of personalized acetabular cup with bone defect repair function
CN111329626A (en) * 2020-03-09 2020-06-26 中南大学湘雅医院 Knee joint spacer and preparation method thereof
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