CN1480111A - Preparation method of individualized artificial half-articular surface substitute and artificial half-joint substitute - Google Patents
Preparation method of individualized artificial half-articular surface substitute and artificial half-joint substitute Download PDFInfo
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Abstract
本发明针对个体化人工半关节面替代物制备方法及关节替代物，个体化半关节面替代物由半关节体、生物连接器、髓内针连接桩和手术定位器组成。其按下述步骤进行：利用患者健侧关节进行CT扫描、图像处理、通过软件进行关节软骨面三维重构；设计半关节体，在其上设计生物连接器和髓内针连接桩，设计定位模，用快速成型机制备成人工半关节面替代物原型；精密熔模铸制备成人工关节；整体装配人工关节。该发明解决个体匹配化制造问题，保留对侧没有受损的关节面，减小手术范围，利于术后康复和功能恢复。对于发育期患者，减少了截骨造成的对骨骺的破坏，最大程度保留肢体发育能力。适应创伤、肿瘤、关节炎等造成的半关节面破坏进行人工关节置换的病例。
The invention is directed to a method for preparing an individualized artificial semi-articular surface substitute and the joint substitute. The individualized semi-articular surface substitute is composed of a semi-articular body, a biological connector, an intramedullary needle connecting post and a surgical positioner. It is carried out in the following steps: use the healthy side of the patient to perform CT scanning, image processing, and three-dimensional reconstruction of the articular cartilage surface through software; design a half-joint body, design a biological connector and an intramedullary needle connecting post on it, and design a positioning The prototype of the artificial semi-articular surface substitute is prepared by rapid prototyping machine; the artificial joint is prepared by precision investment casting; the artificial joint is assembled as a whole. The invention solves the problem of individual matching manufacturing, preserves the undamaged articular surface on the contralateral side, reduces the scope of surgery, and facilitates postoperative rehabilitation and functional recovery. For developing patients, the damage to the epiphysis caused by osteotomy is reduced, and the ability of limb development is preserved to the greatest extent. It is suitable for the cases of artificial joint replacement for hemiarticular surface damage caused by trauma, tumor, arthritis, etc.
Description
一、技术领域1. Technical field
本发明涉及医疗行业的骨关节修复。The invention relates to bone and joint repair in the medical industry.
二、背景技术2. Background technology
现有技术使用的人工关节替代物有两种方式：一种方法是双侧全置换人工关节，它切除了对侧尚没有受损的关节面，增加了手术范围，不利于术后康复和功能恢复，特别是对于发育期的青少年患者，截骨造成的对骨骺的破坏，破坏了肢体的发育能力；另一种方法是用异体骨移植，它存在手术后关节面坏死及关节面匹配性差，从而影响关节功能恢复的问题。以上方法均难以解决个体化置换。There are two methods of artificial joint substitutes used in the prior art: one method is bilateral total replacement of artificial joints, which removes the undamaged articular surface on the opposite side, increases the scope of surgery, and is not conducive to postoperative rehabilitation and function Recovery, especially for young patients in the developing period, the damage to the epiphysis caused by osteotomy will destroy the developmental ability of the limbs; another method is to use allogeneic bone transplantation, which has articular surface necrosis and poor matching of the articular surface after operation. Thereby affecting the recovery of joint function. The above methods are difficult to solve individual replacement.
三、发明内容3. Contents of the invention
本发明的发明目的是提供一种利用计算机辅助设计(CAD)和快速成型(Rapid Prototyping)技术，依据病人CT图像设计和制造个体化人工半关节面替代物制备方法。The invention object of the present invention is to provide a kind of utilization computer-aided design (CAD) and rapid prototyping (Rapid Prototyping) technology, design and manufacture individualized artificial hemiarticular surface substitute preparation method according to patient's CT image.
本发明的另一发明目的是提供个体化人工半关节面替代物。Another object of the present invention is to provide individualized artificial hemiarticular surface substitutes.
本发明提供针对以上个体化人工半关节面替代物的手术定位器。The present invention provides a surgical positioner for the above individualized artificial half articular surface substitute.
实现发明目的的技术方案是这样解决的：个体化人工半关节面替代物制备方法依次按下述步骤进行：The technical solution for realizing the purpose of the invention is solved in this way: the preparation method of the individualized artificial semi-articular surface substitute is carried out in sequence according to the following steps:
a、利用患者健全侧关节进行CT扫描，获取骨组织图像数据；a. Use the patient's healthy side joints to perform CT scans to obtain bone tissue image data;
b、利用图像处理技术，对图象数据进行镜面对称处理，依据软组织与骨质在CT图像中灰度的差异进行图像分割，提取轮廓数据，得到关节软骨和骨骼轮廓数据；b. Using image processing technology, image data is mirror-symmetrically processed, image segmentation is performed based on the gray level difference between soft tissue and bone in the CT image, and contour data is extracted to obtain articular cartilage and bone contour data;
c、将获得的骨轮廓数据，输入反求软件或CAD软件进行关节骨面三维重构；c. Input the obtained bone contour data into reverse software or CAD software for three-dimensional reconstruction of the articular bone surface;
d、在关节骨面上设计生物连接器和髓内针联接桩；d. Design biological connectors and intramedullary nail coupling posts on the articular bone surface;
e、按照所设计的个体化人工半关节面，进行手术定位器的设计与制造；e. According to the designed individualized artificial semi-articular surface, design and manufacture the surgical positioner;
f、将设计好的CAD模型转化成快速成型文件格式，用快速成型技术制备成人工半关节面替代物的原型；f. Convert the designed CAD model into a rapid prototyping file format, and use rapid prototyping technology to prepare a prototype of the artificial half articular surface substitute;
g、对原型实施后处理，精密熔模铸制备成人工半关节替代物；g. Perform post-processing on the prototype, and prepare artificial half-joint substitutes by precision investment casting;
h、整体装配人工半关节。h. Overall assembly of the artificial half joint.
本发明提供单侧关节面的替代物治疗方法，仅更换受损的单侧关节面，且关节面替代物的外表面其受损前的关节面相同，实现了替代物与对侧关节面的匹配运动。在关节面替代物的内表面的连接结构，面上安装有生物连接器和髓内针连接桩。生物连接器为与髓内针方向平行的圆柱筒，筒周围开有4-6mm的小孔，其中将填入自体松质骨或人工生物材料。髓内针连接桩是内表面上的一个圆柱台，圆柱台中为锥度为自锁莫氏锥度的锥孔，其方向的确定方法为：分别取病人股骨的最大截面和最小截面，连接两截面的中心，该方向为得髓内针连接桩的方向；髓内针连接桩将与手术中安装的髓内针连接。为保证手术关节面替代物的安装，发明关节面替代物的手术定位器，其结构包括定位模和装夹器。定位模以关节面的曲面为基准面的快速成型件，其中有三个定位孔，分别对应髓内针和生物连接器方向和尺寸。手术定位器包括由装夹器的基座、底端夹具和顶端夹具组成，固定定位模和修复骨，便于手术操作。The invention provides a unilateral articular surface replacement treatment method, only the damaged unilateral articular surface is replaced, and the outer surface of the articular surface substitute is the same as the articular surface before damage, realizing the replacement of the replacement and the contralateral articular surface Match sports. In the connection structure of the inner surface of the articular surface substitute, a biological connector and an intramedullary nail connection post are installed on the surface. The biological connector is a cylinder parallel to the direction of the intramedullary needle, and there are small holes of 4-6 mm around the cylinder, which will be filled with autologous cancellous bone or artificial biomaterials. The intramedullary nail connection post is a cylindrical pedestal on the inner surface, and the taper in the cylindrical pedestal is a taper hole with a self-locking Morse taper. The method for determining the direction is: respectively take the largest section and the smallest section of the patient's femur, and connect the two sections. Center, which is the direction to get the intramedullary nail connecting post; the intramedullary nail connecting post will be connected with the intramedullary nail installed during the operation. In order to ensure the installation of the surgical articular surface substitute, a surgical positioner for the articular surface substitute is invented, and its structure includes a positioning mold and a clamp. The positioning mold is a rapid prototyping part based on the curved surface of the articular surface, and there are three positioning holes in it, corresponding to the direction and size of the intramedullary needle and the biological connector. The operation positioner consists of the base of the clamper, the bottom clamp and the top clamp, and fixes the positioning mold and repairs the bone, which is convenient for operation.
本发明与目前常用的全关节置换相比，不仅解决了个体匹配化制造问题，同时保留了对侧没有受损的关节面，减小了手术范围，利于术后康复和功能恢复。特别是对于发育期的青少年患者，减少了截骨造成的对骨骺的破坏，最大程度保留肢体的发育能力。整个系统均采用快速制造技术，对于创伤等需要在短时间内手术治疗的病例提供了时间上的保障。生物连接器和髓内针系统可以实现假体与宿主骨的生物性连接，减少松动、疼痛等晚期并发症。适用于对侧关节面正常的半关节损伤患者，包括创伤、肿瘤、关节炎等各种原因造成的半关节面破坏需要进行人工关节置换的病例。可以根据每一位患者的不同损伤情况进行个体化的设计与制造。Compared with the currently commonly used total joint replacement, the present invention not only solves the problem of individual matching manufacturing, but also preserves the undamaged articular surface on the contralateral side, reduces the scope of operation, and facilitates postoperative rehabilitation and functional recovery. Especially for adolescent patients in the developing period, the damage to the epiphysis caused by osteotomy is reduced, and the developmental ability of the limbs is preserved to the greatest extent. The entire system adopts rapid manufacturing technology, which provides time guarantee for cases such as trauma that require surgical treatment in a short time. The biological connector and intramedullary nail system can realize the biological connection between the prosthesis and the host bone, and reduce late complications such as loosening and pain. It is suitable for patients with hemiarticular injury with normal contralateral articular surface, including cases where artificial joint replacement is required for hemiarticular surface damage caused by various reasons such as trauma, tumor, and arthritis. Individualized design and manufacture can be carried out according to the different injury conditions of each patient.
仿生个体化人工半关节替代物具有以下特点：①关节内面带两个生物连接器，手术时内置自体骨及BMP、FGF、TGF等骨生长因子，起生物固定关节面的作用。②人工关节面以患者患侧关节软骨外表面轮廓为外表面。内表面因手术不同而定，可以是异体骨外表面，也可以是手术修正后的自体骨外表面。③人工关节与髓内针相结合。④个体化制造。该设计和制造可达到人工关节面与患者正常侧关节面的最佳匹配。The bionic individualized artificial half-joint substitute has the following characteristics: ① There are two biological connectors on the inner surface of the joint. Autologous bone and bone growth factors such as BMP, FGF, and TGF are built in during the operation to biologically fix the articular surface. ②The outer surface of the artificial articular surface is the contour of the outer surface of the articular cartilage on the affected side of the patient. The inner surface depends on different operations, it can be the outer surface of allogeneic bone, or the outer surface of autogenous bone after surgical revision. ③The combination of artificial joint and intramedullary nail. ④Individualized manufacturing. The design and manufacture can achieve the best matching of the artificial joint surface and the patient's normal side joint surface.
提出的针对个体化人工半关节替代物，解决异体骨移植手术后关节面坏死及关节面匹配性差，从而影响关节功能恢复的问题。提出的利用现代计算机和工程学技术，依据病人CT图像复制替代的关节面形状的个体化人工半关节面制造方法。用该种方法制造出的关节面与大段异体骨或自体骨配合使用，以解决异体骨单侧移植手术中关节软骨坏死的问题。可取得关节面理想的生理学重建和后期良好的功能。The proposed individualized artificial half-joint substitute solves the problem of articular surface necrosis and poor matching of the articular surface after allograft bone transplantation, which affects the recovery of joint function. Proposed using modern computer and engineering technology, based on the patient's CT image to copy the shape of the replacement articular surface individualized artificial hemiarticular surface manufacturing method. The articular surface produced by this method is used together with a large segment of allograft bone or autogenous bone to solve the problem of articular cartilage necrosis in unilateral allograft bone transplantation. Ideal physiological reconstruction of the articular surface and good function in the later period can be achieved.
四、附图说明4. Description of drawings
图1为本发明的制备流程图；Fig. 1 is the preparation flowchart of the present invention;
图2为关节内表面结构示意图；Figure 2 is a schematic diagram of the structure of the inner surface of the joint;
图3为关节外表面结构示意图；3 is a schematic diagram of the structure of the outer surface of the joint;
图4为手术定位器结构示意图。Fig. 4 is a schematic structural diagram of the surgical positioner.
五、具体实施方式5. Specific implementation
附图为本发明的其中一种实施例。The accompanying drawing is one of the embodiments of the present invention.
下面结合附图对本发明的内容作进一步说明：Below in conjunction with accompanying drawing, content of the present invention will be further described:
参照图1所示，流程图即为本发明的制备方法，依次按下述步骤进行：Shown in Fig. 1 with reference to, flowchart is exactly the preparation method of the present invention, carries out by following steps successively:
a、利用患者健全侧关节进行CT扫描，获取骨组织图像数据；a. Use the patient's healthy side joints to perform CT scans to obtain bone tissue image data;
b、利用图像处理技术，对图象数据进行镜面对称处理，依据软组织与骨质在CT图像中灰度的差异进行图像分割，提取轮廓数据，得到关节软骨和骨骼轮廓数据；b. Using image processing technology, image data is mirror-symmetrically processed, image segmentation is performed based on the gray level difference between soft tissue and bone in the CT image, and contour data is extracted to obtain articular cartilage and bone contour data;
c、将获得的骨轮廓数据，输入反求软件或CAD软件进行关节骨面三维重构；c. Input the obtained bone contour data into reverse software or CAD software for three-dimensional reconstruction of the articular bone surface;
d、在关节骨面上设计生物连接器和髓内针联接桩，以提高假体在人体内安装的牢固性；d. Design biological connectors and intramedullary nail coupling posts on the articular bone surface to improve the firmness of the prosthesis installed in the human body;
e、按照所设计的个体化人工半关节面，进行手术定位器的设计与制造；e. According to the designed individualized artificial semi-articular surface, design and manufacture the surgical positioner;
f、将设计好的CAD模型转化成快速成型文件格式，用快速成型技术制备成人工半关节面替代物的原型；f. Convert the designed CAD model into a rapid prototyping file format, and use rapid prototyping technology to prepare a prototype of the artificial half articular surface substitute;
g、对原型实施后处理，精密熔模铸制备成人工半关节替代物；g. Perform post-processing on the prototype, and prepare artificial half-joint substitutes by precision investment casting;
h、整体装配人工半关节。h. Overall assembly of the artificial half joint.
快速成型技术，是一种新兴的数字化制造技术，在计算机的控制下，根据物体的CAD模型或CT等数据，通过材料的堆积成型，快速制造任意结构的原型。快速成型技术的特点是特别适合于复杂结构物件、单件或小批量物件的生产。在医学领域与CT结合，针对单侧关节面精确匹配的个体化特殊要求，可以实现关节等生物替代物个体化快速制造。Rapid prototyping technology is an emerging digital manufacturing technology. Under the control of the computer, according to the CAD model or CT data of the object, the prototype of any structure can be rapidly manufactured through the accumulation of materials. The characteristic of rapid prototyping technology is that it is especially suitable for the production of complex structural objects, single-piece or small-batch objects. Combined with CT in the medical field, it can realize individualized and rapid manufacturing of biological substitutes such as joints for the individualized special requirements of precise matching of unilateral articular surfaces.
图2、图3、图4所示，个体化半关节面替代物包括由半关节体4、生物连接器1、髓内针连接桩3和手术定位器组成。个体化半关节面替代物为金属材料制造。在半关节体4替代物的内表面2的连接结构上安装有生物连接器1和髓内针连接桩3，生物连接器1设有其结构为与髓内针方向平行的圆柱筒，筒周围开有4-6mm的小孔，其中将填入自体松质骨或人工生物材料。髓内针连接桩3是内表面2上的一个圆柱台，圆柱台中为锥度为自锁莫氏锥度(3°)的锥孔，其方向的确定方法为：分别取病人股骨的最大截面和最小截面，连接两截面的中心，该方向为得髓内针连接桩3的方向；髓内针连接桩3将与手术中安装的髓内针连接。为保证手术关节面替代物的安装，发明关节面替代物的手术定位器，其结构包括定位模和装夹器。定位模12以关节面的曲面为基准面的快速成型件，其中有三个定位孔，分别是髓内针瞄准孔5和生物连接器瞄准孔6，装夹器由基座9、底端夹具10和顶端夹具11组成，用于固定定位模12和被修复骨8，定位模12的曲面与被修复骨8上的关节面曲面7相同。As shown in Fig. 2, Fig. 3 and Fig. 4, the individualized hemiarticular surface substitute consists of a hemiarticular body 4, a biological connector 1, an intramedullary nail connecting post 3 and a surgical positioner. Individualized hemiarticular replacements are made of metal materials. On the connection structure of the inner surface 2 of the half-joint body 4 substitute, a biological connector 1 and an intramedullary needle connection post 3 are installed. The biological connector 1 is provided with a cylindrical cylinder whose structure is parallel to the direction of the intramedullary needle. A small hole of 4-6mm is opened, which will be filled with autologous cancellous bone or artificial biomaterial. The intramedullary nail connecting post 3 is a cylindrical platform on the inner surface 2, and in the cylindrical platform is a tapered hole whose taper is a self-locking Morse taper (3°). The section connects the centers of the two sections, and this direction is the direction of obtaining the intramedullary nail connecting post 3; the intramedullary nail connecting post 3 will be connected with the intramedullary nail installed in the operation. In order to ensure the installation of the surgical articular surface substitute, a surgical positioner for the articular surface substitute is invented, and its structure includes a positioning mold and a clamp. The positioning mold 12 is a rapid prototyping part with the curved surface of the articular surface as the reference surface, and there are three positioning holes, which are respectively the aiming hole 5 of the intramedullary needle and the aiming hole 6 of the biological connector. Composed of the top clamp 11, used to fix the positioning mold 12 and the repaired bone 8, the curved surface of the positioning mold 12 is the same as the articular surface curved surface 7 on the repaired bone 8.
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Cited By (23)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN100528103C (en) * | 2007-08-14 | 2009-08-19 | 西安交通大学 | Bionic artificial semi-joint body and manufacturing technique thereof |
| CN100588379C (en) * | 2008-06-26 | 2010-02-10 | 上海交通大学 | Preparation method of artificial joint prosthesis with locally controllable porous structure |
| CN101879086A (en) * | 2010-06-22 | 2010-11-10 | 中国人民解放军第三军医大学第一附属医院 | Fabrication method for fracture fixator |
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2003
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