技术领域technical field
本发明涉及医疗器械领域，尤其涉及一种人工膝关节置换术用股骨远端及胫骨平台个性化截骨定位导向装置及使用方法。The invention relates to the field of medical devices, in particular to a personalized osteotomy positioning guide device for distal femur and tibial plateau for artificial knee replacement and a method of use.
背景技术Background technique
人工膝关节置换手术的首要目标之一是恢复下肢机械力线，使髋关节旋转中心、膝关节中点和踝关节中点在冠状面上位于一条假想下肢力线上。正确的截骨是术后获得良好下肢对线的基础。One of the primary goals of artificial knee replacement surgery is to restore the mechanical line of force of the lower extremity, so that the center of rotation of the hip joint, the midpoint of the knee joint, and the midpoint of the ankle joint lie on an imaginary line of force of the lower extremity on the coronal plane. Correct osteotomy is the basis for good lower limb alignment after operation.
目前临床上人工膝关节置换术中最为常用的截骨定位方法是股骨髓内定位技术及胫骨髓外定位技术。确保术中股骨髓内杆准确指示股骨远端解剖轴线的方向是股骨髓内定位技术的操作关键点之一。术中操作时，扩髓的入口位置、方向、深度以及直径等多种因素都会影响并引起髓内杆位置偏差，致使髓内杆不能够准确指示股骨远端解剖轴的方向。因此，股骨髓内定位技术潜在误差风险较高，临床研究也证实了这一观点。胫骨髓外定位技术中，通常将抱踝器固定在小腿外部，通过目测将髓外杆远端指示踝关节中点的体表对应位置，近端指示胫骨平台关节面上髁间嵴中心位置来确定胫骨力线。由于通过目测踝关节体表外形，定位踝关节中点的精准度不高，定位偏差可导致产生明显的胫骨平台截骨偏差。因此，利用常规的股骨髓内定位截骨装置和胫骨髓外定位截骨装置出现截骨偏差的潜在风险较高，容易导致术后下肢机械力线偏差，影响手术疗效。At present, the most commonly used osteotomy positioning methods in artificial knee arthroplasty are femoral intramedullary positioning technology and tibial extramedullary positioning technology. Ensuring that the femoral intramedullary rod accurately indicates the direction of the anatomical axis of the distal femur is one of the key points in the operation of femoral intramedullary positioning techniques. During the operation, various factors such as the entrance position, direction, depth and diameter of the reamed medulla will affect and cause the position deviation of the intramedullary rod, so that the intramedullary rod cannot accurately indicate the direction of the anatomical axis of the distal femur. Therefore, the risk of potential error in femoral intramedullary positioning technology is high, and clinical studies have also confirmed this point of view. In the tibial extramedullary positioning technique, the ankle gripper is usually fixed on the outside of the calf, and the distal end of the extramedullary rod indicates the corresponding position on the body surface of the midpoint of the ankle joint, and the proximal end indicates the center of the intercondylar ridge on the articular surface of the tibial plateau. Determine the alignment of the tibia. Because the accuracy of locating the midpoint of the ankle joint is not high through visual inspection of the surface shape of the ankle joint, positioning deviation can lead to obvious deviation of tibial plateau osteotomy. Therefore, using the conventional femoral intramedullary positioning osteotomy device and tibial extramedullary positioning osteotomy device has a high potential risk of osteotomy deviation, which may easily lead to deviation of the mechanical force line of the lower limbs after operation and affect the surgical efficacy.
计算机辅助导航定位技术和3D打印个性化截骨导板定位技术是确定股骨远端和胫骨近端截骨方向的两种新兴技术。计算机辅助导航定位技术是通过个体化的手术设计和实时导航，对截骨和下肢机械力线对线角度等数据进行量化，并根据术中具体情况确定是否存在信息误差，并进行及时修正的一种定位技术。计算机辅助导航定位技术能够显著提高膝关节置换手术的截骨精确度，但该技术因对设备要求高而不能广泛应用。3D打印个性化截骨导板定位技术是根据术前下肢CT或MRI影像重建，借助计算机辅助设计，确定截骨角度与厚度，采用3D打印技术构建患者个性化截骨导向模块，术中通过将3d打印的个性化截骨导向模块与关节面特定区域贴合匹配从而确定术中截骨方向。根据目前大部分临床研究报道，3D打印个体化截骨导板定位技术在截骨精确度上与传统截骨定位技术相比，并无显著优势，但大大增加了医疗成本。Computer-aided navigation positioning technology and 3D printing personalized osteotomy guide positioning technology are two emerging technologies to determine the osteotomy direction of the distal femur and proximal tibia. Computer-aided navigation and positioning technology is to quantify data such as osteotomy and lower limb mechanical force line alignment angle through individualized surgical design and real-time navigation, and determine whether there is information error according to the actual situation in the operation, and make timely corrections. positioning technology. Computer-aided navigation and positioning technology can significantly improve the accuracy of osteotomy in knee replacement surgery, but this technology cannot be widely used due to high equipment requirements. 3D printing personalized osteotomy guide plate positioning technology is based on preoperative CT or MRI image reconstruction of the lower limbs, with the help of computer-aided design, determine the osteotomy angle and thickness, and use 3D printing technology to construct the patient's personalized osteotomy guide module. The printed personalized osteotomy guide module fits and matches with the specific area of the articular surface to determine the direction of osteotomy during operation. According to most current clinical research reports, 3D printing personalized osteotomy guide plate positioning technology has no significant advantages in osteotomy accuracy compared with traditional osteotomy positioning technology, but it greatly increases medical costs.
故研发一套高性价比的个性化截骨定位导线装置，使之具备较高的个性化精确度和临床适用性，提高股骨远端及胫骨平台截骨手术精确度，改善术后效果，是目前人工膝关节置换手术的重要难点之一。Therefore, developing a set of cost-effective personalized osteotomy positioning guide wire device, so that it has high personalized accuracy and clinical applicability, improves the accuracy of distal femoral and tibial plateau osteotomy, and improves the postoperative effect. One of the important difficulties in artificial knee replacement surgery.
发明内容Contents of the invention
有鉴于此，有必要针对上述问题，提供一种股骨远端及胫骨平台个性化截骨定位导向装置及使用方法。In view of this, it is necessary to provide a personalized osteotomy positioning guide device for the distal end of the femur and the tibial plateau and a method of use to address the above problems.
为了实现上述目的，本发明采用如下技术方案：In order to achieve the above object, the present invention adopts the following technical solutions:
股骨远端及胫骨平台个性化截骨定位导向装置，包含股骨前皮质定位导向器和截骨厚度测量器；所述股骨前皮质定位导向器包含第一定位板和L型杆，第一定位板上设有固定槽，L型杆包含定位杆及位于其一端部的固定杆，固定杆穿过固定槽；所述截骨厚度测量器包含第二定位板、圆柱刻度尺和指示杆，第二定位板具有定位卡口，所述圆柱刻度尺可拆卸的安装在第二定位板上，所述圆柱刻度尺设有开孔，指示杆一端部设有指示柱，指示杆穿过开孔，指示柱位于第二定位板的定位卡口的开口侧。The personalized osteotomy positioning guide device for the distal end of the femur and the tibial plateau includes a femoral anterior cortical positioning guide and an osteotomy thickness measuring device; the femoral anterior cortical positioning guide includes a first positioning plate and an L-shaped rod, and the first positioning plate The L-shaped rod includes a positioning rod and a fixing rod at one end thereof, and the fixing rod passes through the fixing groove; the osteotomy thickness measuring device includes a second positioning plate, a cylindrical scale and an indicating rod, and the second The positioning plate has a positioning bayonet, and the cylindrical scale is detachably installed on the second positioning plate. The cylindrical scale is provided with an opening, and one end of the indicating rod is provided with an indicating column, and the indicating rod passes through the opening to indicate The column is located at the opening side of the positioning bayonet of the second positioning plate.
优选的，所述第一定位板包含两个固定槽板及连接二者的贴合板，每个定位槽板上设有一个固定槽。Preferably, the first positioning plate includes two fixing groove plates and a bonding plate connecting them, and each positioning groove plate is provided with a fixing groove.
优选的，所述第一定位板包含一个固定槽板及与其相接的贴合板，定位槽板上设有一个固定槽。Preferably, the first positioning plate includes a fixing groove plate and a bonding plate connected to it, and a fixing groove is provided on the positioning groove plate.
优选的，固定槽板的边缘开口或不开口，所述贴合板为多边形板、圆形板或椭圆形板。Preferably, the edge of the fixing groove plate is open or not, and the said bonding plate is a polygonal plate, a circular plate or an oval plate.
优选的，所述L型杆的固定杆与定位杆之间的角度为90°、91°、92°或93°。Preferably, the angle between the fixing rod and the positioning rod of the L-shaped rod is 90°, 91°, 92° or 93°.
优选的，所述定位杆中部设有划线槽。Preferably, a scoring groove is provided in the middle of the positioning rod.
优选的，所述第二定位板为C形板、多边形板、圆形板或椭圆形板。Preferably, the second positioning plate is a C-shaped plate, a polygonal plate, a circular plate or an oval plate.
优选的，所述定位卡口为C形、半圆形、半椭圆形或抛物线形。Preferably, the positioning bayonet is C-shaped, semi-circular, semi-elliptical or parabolic.
优选的，所述第二定位板中部设有两块相对设置的固定围板，固定围板内侧为圆弧面，圆柱刻度尺可滑动的安装在所述两块固定围板之间，固定围板的高度与圆柱刻度尺的高度相同。Preferably, the middle part of the second positioning plate is provided with two oppositely arranged fixed enclosures, the inner side of the fixed enclosure is an arc surface, and the cylindrical scale is slidably installed between the two fixed enclosures, and the fixed enclosure The height of the plate is the same as that of the cylinder scale.
使用所述股骨远端及胫骨平台个性化截骨定位导向装置确定截骨方向和厚度的方法，包括以下步骤：The method for determining the osteotomy direction and thickness using the personalized osteotomy positioning guide device of the distal end of the femur and the tibial plateau comprises the following steps:
S1、确定内侧髁和外侧髁截骨的最大厚度：根据下肢CT或MRI扫描数据，结合三维建模图像分析软件，按照截骨要求模拟膝关节截骨操作，通过测量截骨块的三维解剖形态，获得股骨侧及胫骨侧内外侧髁截骨的最大厚度；S1. Determine the maximum thickness of the osteotomy of the medial condyle and lateral condyle: According to the CT or MRI scanning data of the lower limbs, combined with the 3D modeling image analysis software, the knee joint osteotomy operation is simulated according to the osteotomy requirements, and the 3D anatomical shape of the osteotomy block is measured , to obtain the maximum thickness of femoral and tibial medial and lateral condyle osteotomy;
S2、确定股骨远端在矢状面上的截骨方向：将第一定位板贴合股骨远端的前皮质表面，根据选用假体类型，选择相应角度的L形杆，将其固定杆插入固定槽内，按照定位杆的指示划方向线，股骨内外侧髁侧面的方向线均确定后，两条方向线即为股骨远端在矢状面上的截骨方向；S2. Determine the osteotomy direction of the distal femur on the sagittal plane: fit the first positioning plate to the anterior cortical surface of the distal femur, select an L-shaped rod with a corresponding angle according to the type of prosthesis selected, and insert the fixing rod In the fixing groove, draw a direction line according to the instructions of the positioning rod. After the direction lines on the side of the medial and lateral femoral condyle are determined, the two direction lines are the osteotomy direction of the distal femur on the sagittal plane;
S3、确定股骨远端在冠状面上的截骨方向及截骨厚度：将第二定位板的定位开口临时固定在股骨髁远端的两侧，第二定位板与步骤S2中的两条方向线平行，通过调节指示杆的位置，使其指示柱端点指示内外侧髁端点位置，调节第二定位板的位置，使内外侧髁的截骨厚度均与步骤S1中测量的相应的截骨块厚度相同；S3. Determine the osteotomy direction and osteotomy thickness of the distal end of the femur on the coronal plane: temporarily fix the positioning opening of the second positioning plate on both sides of the distal end of the femoral condyle, the second positioning plate and the two directions in step S2 Lines are parallel, by adjusting the position of the indicating rod so that the end point of the indicating column indicates the end point position of the medial and lateral condyle, adjust the position of the second positioning plate, so that the osteotomy thickness of the medial and lateral condyle is the same as the corresponding osteotomy piece measured in step S1 the same thickness;
S4、确定胫骨平台的截骨方向及截骨厚度：将第二定位板的定位开口临时固定在胫骨平台内外侧，通过调节指示杆的位置，使其指示柱端点指示内外侧髁中点位置，调节第二定位板的位置，使内外侧髁的截骨厚度均与步骤S1中测量的相应的截骨块厚度相同。S4. Determine the osteotomy direction and osteotomy thickness of the tibial plateau: temporarily fix the positioning opening of the second positioning plate on the inner and outer sides of the tibial plateau, and adjust the position of the indicator rod so that the end point of the indicator column indicates the midpoint of the inner and outer condyles. Adjust the position of the second positioning plate so that the thickness of the osteotomy of the medial and lateral condyles is the same as the thickness of the corresponding osteotomy piece measured in step S1.
本发明股骨远端及胫骨平台个性化截骨定位导向装置及使用方法，术前利用下肢全长CT或MRI扫描数据，结合三维建模图像分析软件，根据下肢对线要求，模拟人工膝关节置换术中截骨，测量获得股骨侧及胫骨侧内外侧髁截骨块的厚度；术中充分显露膝关节面，股骨侧以股骨内外侧髁关节面最远端作为定位基准点，胫骨侧以胫骨内外侧髁关节面中心点作为基准点，利用本发明股骨远端及胫骨平台个性化截骨定位导向装置，在术中调节定位板的方向，使内外侧髁截骨厚度均与预定厚度一致。本发明是针对膝关节置换手术向着个性化、精确化发展趋势而研发的高性价比、个性化、高精确度的截骨定位导向装置。与现有技术相比，本发明具有如下有益效果：The personalized osteotomy positioning guide device for the distal femur and the tibial plateau and the method of use of the present invention use full-length CT or MRI scanning data of the lower limbs before operation, combined with three-dimensional modeling image analysis software, and simulate artificial knee joint replacement according to the alignment requirements of the lower limbs Osteotomy was performed during the operation, and the thickness of the femoral and tibial medial and lateral condyle osteotomy pieces was measured; the knee joint surface was fully exposed during the operation, and the distal end of the femoral medial and lateral femoral The center point of the articular surface of the medial and lateral condyles is used as a reference point, and the orientation of the positioning plate is adjusted during the operation by using the personalized osteotomy positioning guide device for the distal end of the femur and the tibial plateau, so that the thickness of the osteotomy of the medial and lateral condyles is consistent with the predetermined thickness. The present invention is a cost-effective, personalized and high-precision osteotomy positioning and guiding device developed for the development trend of knee joint replacement surgery towards personalization and precision. Compared with the prior art, the present invention has the following beneficial effects:
1、本发明结构简单、制备方便、容易使用，具备较高的个性化精确度和临床适用性，适用于基层医疗卫生机构，性价比高；1. The present invention is simple in structure, convenient in preparation, easy to use, has high individualized accuracy and clinical applicability, is suitable for primary medical and health institutions, and has high cost performance;
2、本发明在实现个性化精确截骨的基础上，不依赖与计算机导航和3D打印设备，可有效解决全膝关节置换个性化截骨的技术门槛和成本过高、临床应用少的问题；2. On the basis of realizing personalized and precise osteotomy, the present invention does not rely on computer navigation and 3D printing equipment, and can effectively solve the problems of technical threshold, high cost and few clinical applications of personalized osteotomy in total knee replacement;
3、本发明在实现个性化精确截骨的基础上，不依赖于传统的股骨髓内定位方法和胫骨髓外定位方法，开创性应用髓外个性化定位截骨技术，避免扩髓引起的出血增多、脂肪肺栓塞等并发症。3. On the basis of realizing personalized and precise osteotomy, the present invention does not rely on the traditional femoral intramedullary positioning method and tibial extramedullary positioning method, and pioneers the application of extramedullary personalized positioning osteotomy technology to avoid bleeding caused by reaming Increased, fat pulmonary embolism and other complications.
附图说明Description of drawings
图1为本发明中股骨前皮质定位导向器结构示意图。Fig. 1 is a schematic diagram of the structure of the positioning guide for the anterior cortex of the femur in the present invention.
图2为本发明中截骨厚度测量器结构示意图。Fig. 2 is a schematic structural view of the osteotomy thickness measuring device in the present invention.
图3为本发明中第一定位板结构示意图。Fig. 3 is a schematic diagram of the structure of the first positioning plate in the present invention.
图4为本发明中L型杆结构示意图。Fig. 4 is a schematic diagram of the structure of the L-shaped bar in the present invention.
图5为本发明中截骨厚度测量器具体结构示意图。Fig. 5 is a schematic diagram of the specific structure of the osteotomy thickness measuring device in the present invention.
图6为本发明中股骨前皮质定位导向器确定股骨远端在矢状面上的截骨方向示意图。Fig. 6 is a schematic diagram of determining the osteotomy direction of the distal end of the femur on the sagittal plane by the anterior cortex positioning guide of the present invention.
图7为本发明中截骨厚度测量器确定股骨远端在冠状面上的截骨方向示意图。Fig. 7 is a schematic diagram of determining the osteotomy direction of the distal femur on the coronal plane by the osteotomy thickness measuring device of the present invention.
图8为本发明中截骨厚度测量器确定胫骨平台在冠状面上的截骨方向示意图。Fig. 8 is a schematic diagram of determining the osteotomy direction of the tibial plateau on the coronal plane by the osteotomy thickness measuring device in the present invention.
附图标记为：The reference signs are:
股骨前皮质定位导向器1， 划线槽19，Anterior femoral cortex positioning guide 1, scoring groove 19,
第一定位板11， 截骨厚度测量器2，The first positioning plate 11, the osteotomy thickness measuring device 2,
L型杆12， 第二定位板21，L-shaped bar 12, the second positioning plate 21,
固定槽13， 圆柱刻度尺22，Fixed groove 13, cylindrical scale 22,
定位杆14， 指示杆23，positioning rod 14, indicator rod 23,
固定杆15， 定位卡口24，Fixed rod 15, positioning bayonet 24,
隔板16， 开孔25，Partition 16, opening 25,
定位槽板17， 指示柱26，Positioning groove plate 17, indicating column 26,
贴合板18， 固定围板27。Fitting plate 18, fixed enclosure 27.
具体实施方式Detailed ways
为了更好的说明本发明，下面结合附图和具体实施方式做进一步说明。In order to better illustrate the present invention, further description will be made below in conjunction with the accompanying drawings and specific embodiments.
实施例1Example 1
如图1和图2所示，本发明股骨远端及胫骨平台个性化截骨定位导向装置，包含股骨前皮质定位导向器1和截骨厚度测量器2；股骨前皮质定位导向器1用于确定股骨远端矢状面上的截骨方向，截骨厚度测量器2用于确定股骨远端或胫骨平台冠状面上的截骨方向及厚度。As shown in Fig. 1 and Fig. 2, distal end of femur and tibial plateau individualized osteotomy positioning guide device of the present invention comprise femoral anterior cortex positioning guide 1 and osteotomy thickness measuring device 2; Femoral anterior cortical positioning guide 1 is used for Determine the direction of osteotomy on the sagittal plane of the distal femur, and the osteotomy thickness measuring device 2 is used to determine the direction and thickness of the osteotomy on the coronal plane of the distal femur or the tibial plateau.
优选的，如图2所示，所述股骨前皮质定位导向器1包含第一定位板11和L型杆12，第一定位板11上设有固定槽13，L型杆12包含定位杆14及位于其一端部的固定杆15，固定杆15穿过固定槽13。固定杆15的大小与固定槽13匹配，固定杆15可以在外力作用下在固定槽13内前后、左右滑动，但固定杆15不会固定槽13内自行滑动或晃动。Preferably, as shown in Figure 2, the anterior femoral cortex positioning guide 1 includes a first positioning plate 11 and an L-shaped bar 12, the first positioning plate 11 is provided with a fixing groove 13, and the L-shaped bar 12 includes a positioning bar 14 And a fixed rod 15 located at one end thereof, the fixed rod 15 passes through the fixed slot 13 . The size of the fixed rod 15 matches the fixed groove 13, the fixed rod 15 can slide back and forth, left and right in the fixed groove 13 under the action of external force, but the fixed rod 15 will not slide or shake in the fixed groove 13 by itself.
更优选的，如图2-3所示，所述第一定位板11可以通过多种方式实现。在本发明的一个实施例中，所述第一定位板11包含一个固定槽板17及与其相连的贴合板18，定位槽板17上设有一个固定槽13(图3A)。在本发明的另一个实施例中，所述第一定位板11包含两个固定槽板17及连接二者的贴合板18，每个定位槽板17上设有一个固定槽13(图3B)。固定槽板17的边缘开口或不开口。所述贴合板18为多边形、圆形或椭圆形。贴合板在使用时，贴合板18与股骨前皮质贴合。More preferably, as shown in Fig. 2-3, the first positioning plate 11 can be realized in various ways. In one embodiment of the present invention, the first positioning plate 11 includes a fixing slot plate 17 and a fitting plate 18 connected thereto, and a fixing slot 13 is provided on the positioning slot plate 17 ( FIG. 3A ). In another embodiment of the present invention, the first positioning plate 11 includes two fixing groove plates 17 and a bonding plate 18 connecting the two, and each positioning groove plate 17 is provided with a fixing groove 13 ( FIG. 3B ) . The edge of the fixed groove plate 17 is open or not. The bonding board 18 is polygonal, circular or elliptical. When the fitting plate is in use, the fitting plate 18 is fitted to the anterior cortex of the femur.
更优选的，如图2和图4所示，所述L型杆12的固定杆15与定位杆14之间的角度为90°、91°、92°或93°。在使用时，根据具体情况选择合适角度的L型杆12。优选的，所述定位杆14中部设有划线槽19(图4A)，在使用股骨前皮质定位导向器1确定好截骨方向后，沿划线槽19划出方向线。所述定位杆14也可以不含划线槽19(图4B)，在使用股骨前皮质定位导向器1确定好截骨方向后，可以直接沿定位杆14的壁划出方向线。More preferably, as shown in FIG. 2 and FIG. 4 , the angle between the fixing rod 15 and the positioning rod 14 of the L-shaped rod 12 is 90°, 91°, 92° or 93°. When in use, select an L-shaped bar 12 with a suitable angle according to specific conditions. Preferably, a marking groove 19 ( FIG. 4A ) is provided in the middle of the positioning rod 14 , and after the osteotomy direction is determined using the anterior femoral cortex positioning guide 1 , a direction line is drawn along the marking groove 19 . The positioning rod 14 may also not contain a scoring groove 19 ( FIG. 4B ). After the osteotomy direction is determined using the anterior femoral cortex positioning guide 1 , a direction line can be drawn directly along the wall of the positioning rod 14 .
优选的，如图1和图5所示，所述截骨厚度测量器2包含第二定位板21、圆柱刻度尺22和指示杆23，第二定位板21具有定位卡口24，所述圆柱刻度尺22可拆卸的安装在第二定位板21上，所述圆柱刻度尺22设有开孔25，指示杆23一端部设有指示柱26，指示杆23穿过开孔25，指示柱26位于第二定位板21的定位卡口24的开口侧。Preferably, as shown in Figures 1 and 5, the osteotomy thickness measuring device 2 includes a second positioning plate 21, a cylindrical scale 22 and an indicator rod 23, the second positioning plate 21 has a positioning bayonet 24, and the cylindrical The scale 22 is detachably installed on the second positioning plate 21, the cylindrical scale 22 is provided with an opening 25, and one end of the indicating rod 23 is provided with an indicating post 26, and the indicating rod 23 passes through the opening 25, and the indicating post 26 Located on the opening side of the positioning bayonet 24 of the second positioning plate 21 .
更优选的，所述定位卡口24用于将第二定位板卡21扣在股骨远端或胫骨平台。优选的，所述定位卡口24为C形、半圆形或半椭圆形。所述第二定位板21的形状不限，优选C形板、多边形板、圆形板或椭圆形板。More preferably, the positioning bayonet 24 is used to buckle the second positioning plate 21 on the distal end of the femur or the tibial plateau. Preferably, the positioning bayonet 24 is C-shaped, semi-circular or semi-elliptical. The shape of the second positioning plate 21 is not limited, preferably a C-shaped plate, a polygonal plate, a circular plate or an elliptical plate.
更优选的，所述第二定位板21中部设有两块相对设置的固定围板27，固定围板27内侧为弧面，圆柱刻度尺22安装在所述两块固定围板27之间。固定围板27的大小与圆柱刻度尺22的大小向匹配。固定围板27的高度与圆柱刻度尺22的高度相同，两块固定围板27围成的空间与圆柱刻度尺22的圆周大小相同，圆柱刻度尺22可以在外力作用下在其内旋转及上下可滑动。More preferably, the middle part of the second positioning plate 21 is provided with two oppositely arranged fixed enclosures 27 , the inner side of the fixed enclosures 27 is an arc surface, and the cylindrical scale 22 is installed between the two fixed enclosures 27 . The size of the fixed shroud 27 matches the size of the cylindrical scale 22 . The height of the fixed shroud 27 is the same as that of the cylindrical scale 22, and the space surrounded by the two fixed shrouds 27 is the same size as the circumference of the cylindrical scale 22, and the cylindrical scale 22 can rotate and go up and down in it under the action of an external force. Can slide.
实施例2Example 2
使用所述股骨远端及胫骨平台个性化截骨定位导向装置确定截骨方向和厚度的方法，包括以下步骤：The method for determining the osteotomy direction and thickness using the personalized osteotomy positioning guide device of the distal end of the femur and the tibial plateau comprises the following steps:
S1、确定内侧髁和外侧髁截骨的最大厚度：术前利用股骨全长和胫骨全长CT或MRI扫描数据，结合三维建模图像分析软件，按照截骨要求模拟膝关节截骨操作，通过测量截骨块的三维解剖形态，获得股骨侧及胫骨侧内外侧髁截骨的最大厚度。S1. Determine the maximum thickness of the medial condyle and lateral condyle osteotomy: preoperatively use CT or MRI scan data of the full length of the femur and tibia, combined with 3D modeling and image analysis software, simulate the knee joint osteotomy operation according to the osteotomy requirements, through The three-dimensional anatomical shape of the osteotomy block was measured to obtain the maximum thickness of the femoral and tibial medial and lateral condyle osteotomies.
S2、确定股骨远端在矢状面上的截骨方向：如图6所示，术中充分显露膝关节面，将第一定位板贴合股骨远端的前皮质表面，根据选用假体类型，选择合适角度的L型杆，将L型杆的固定杆插入固定槽内，按照定位杆的指示划方向线，股骨内外侧髁侧面的方向线均确定后，两条方向的方向线即为股骨远端在矢状面上的截骨方向；当定位槽仅能放一条L型杆时，每次只能确定条方向线，股骨内外侧髁的方向线需要分2次确定，当定位槽可以同时放置两条L型杆时，股骨内外侧髁的方向线可以同时1次确定。S2. Determine the osteotomy direction of the distal femur on the sagittal plane: as shown in Figure 6, the knee joint surface is fully exposed during the operation, and the first positioning plate is fitted to the anterior cortical surface of the distal femur. , choose an L-shaped rod with a suitable angle, insert the fixing rod of the L-shaped rod into the fixing groove, and draw a direction line according to the instructions of the positioning rod. The osteotomy direction of the distal femur on the sagittal plane; when only one L-shaped rod can be placed in the positioning slot, only one direction line can be determined each time, and the direction line of the medial and lateral femoral condyles needs to be determined twice. When two L-shaped rods can be placed at the same time, the direction line of the medial and lateral femoral condyles can be determined at the same time.
S3、确定股骨远端在冠状面上的截骨方向及截骨厚度：如图7所示，将第二定位板的定位开口临时固定在股骨髁远端的两侧，第二定位板与步骤S2中的内侧髁侧的方向线平行，将圆柱刻度尺安装到第二定位板上，将指示杆插入圆柱刻度尺的开孔内；通过调节指示杆的位置，使其指示柱端点指示内侧髁端点位置，圆柱刻度尺与第二定位板的相对位置随指示杆位置变化而变化，比较实际测定的内侧髁截骨厚度与术前测量预定内侧髁的截骨厚度，再进一步调节第二定位板的位置，修正股骨远端截骨面的位置，直到内侧髁的截骨厚度与步骤S1中测量的股骨远端内侧髁的截骨块厚度相同；按照相同的方法测定股骨外侧髁的截骨厚度；S3. Determine the osteotomy direction and osteotomy thickness of the distal end of the femur on the coronal plane: as shown in Figure 7, the positioning opening of the second positioning plate is temporarily fixed on both sides of the distal end of the femoral condyle, the second positioning plate and the step In S2, the direction line on the side of the medial condyle is parallel, install the cylindrical scale on the second positioning plate, and insert the indicating rod into the opening of the cylindrical scale; adjust the position of the indicating rod so that the end point of the indicating column indicates the medial condyle The end position, the relative position between the cylindrical scale and the second positioning plate changes with the position of the indicator rod, compare the actual measured medial condylar osteotomy thickness with the preoperative measured medial condylar osteotomy thickness, and then further adjust the second positioning plate Correct the position of the osteotomy surface of the distal femur until the osteotomy thickness of the medial femoral condyle is the same as the thickness of the osteotomy block of the distal medial femoral condyle measured in step S1; measure the osteotomy thickness of the lateral femoral condyle in the same way ;
S4、确定胫骨平台在冠状面上的截骨方向及截骨厚度：如图8所示，将第二定位板的定位开口临时固定在胫骨平台内外侧，将圆柱刻度尺安装到第二定位板上，将指示杆插入圆柱刻度尺的开孔内；通过调节指示杆的位置，使其指示柱端点指示内侧髁中点位置，圆柱刻度尺与第二定位板的相对位置随指示杆位置变化而变化，比较实际测定的内侧髁截骨厚度与术前测量预定内侧髁的截骨厚度，再进一步调节第二定位板的位置，修正胫骨平台截骨面的位置，直到内侧髁的截骨厚度与步骤S1中测量的胫骨平台内侧髁的截骨块厚度相同；按照相同的方法测定胫骨外侧髁的截骨厚度。S4. Determine the osteotomy direction and osteotomy thickness of the tibial plateau on the coronal plane: as shown in Figure 8, temporarily fix the positioning opening of the second positioning plate on the inside and outside of the tibial plateau, and install the cylindrical scale on the second positioning plate Insert the indicating rod into the opening of the cylindrical scale; by adjusting the position of the indicating rod so that the end point of the indicating rod indicates the midpoint of the medial condyle, the relative position of the cylindrical scale and the second positioning plate changes with the position of the indicating rod. Change, compare the actual measured osteotomy thickness of the medial condyle with the pre-measured osteotomy thickness of the medial condyle, and then further adjust the position of the second positioning plate to correct the position of the osteotomy surface of the tibial plateau until the osteotomy thickness of the medial condyle is the same as that of the medial condyle. The thickness of the osteotomy piece of the medial tibial plateau condyle measured in step S1 is the same; the osteotomy thickness of the lateral tibial condyle is determined by the same method.
本发明股骨远端及胫骨平台个性化截骨定位导向装置，术前利用下肢全长CT或MRI扫描数据，结合三维建模图像分析软件，根据下肢对线要求，模拟人工膝关节置换术中截骨，测量获得股骨侧及胫骨侧内外侧髁截骨块的厚度；术中充分显露膝关节面，股骨侧以股骨内外侧髁关节面最远端作为定位基准点，胫骨侧以胫骨内外侧髁关节面中心点作为基准点，利用本发明股骨远端及胫骨平台个性化截骨定位导向装置，在术中调节定位板的方向，使内外侧髁截骨厚度均与预定厚度一致。The personalized osteotomy positioning and guiding device for distal femur and tibial plateau of the present invention utilizes full-length CT or MRI scanning data of the lower limbs before operation, combines with three-dimensional modeling image analysis software, and simulates osteotomy during artificial knee joint replacement according to the alignment requirements of the lower limbs. The bone was measured to obtain the thickness of the femoral and tibial medial and lateral condyle osteotomy pieces; the knee joint surface was fully exposed during the operation, and the distal end of the femoral medial and lateral femoral condyle articular surface was used as the reference point for the femoral side, and the tibial medial and lateral condyle was used as the positioning reference point. The center point of the articular surface is used as a reference point, and the orientation of the positioning plate is adjusted during the operation by using the personalized osteotomy positioning guide device for the distal end of the femur and the tibial plateau so that the thickness of the osteotomy of the medial and lateral condyles is consistent with the predetermined thickness.
本发明是针对膝关节置换手术向着个性化、精确化发展趋势而研发的高性价比、个性化、高精确度的截骨定位导向装置，本发明结构简单、制备方便、容易使用，适用于基层医疗卫生机构和临床应用。本发明在实现个性化精确截骨的基础上，不依赖与计算机导航和3D打印设备，可有效解决全膝关节置换个性化截骨的技术门槛和成本过高、临床应用少的问题；本发明在实现个性化精确截骨的基础上，不依赖于传统的股骨髓内定位方法和胫骨髓外定位方法，开创性应用髓外个性化定位截骨技术，避免扩髓引起的出血增多、脂肪肺栓塞等并发症。The present invention is a cost-effective, personalized, and high-precision osteotomy positioning and guiding device developed for the development trend of knee joint replacement surgery toward individualization and precision. The invention has simple structure, convenient preparation, and easy use, and is suitable for primary medical care Health institutions and clinical applications. On the basis of realizing personalized and accurate osteotomy, the present invention does not rely on computer navigation and 3D printing equipment, and can effectively solve the problems of technical threshold, high cost and few clinical applications of personalized osteotomy for total knee joint replacement; On the basis of realizing personalized and precise osteotomy, it does not rely on the traditional femoral intramedullary positioning method and tibial extramedullary positioning method, and pioneers the application of extramedullary personalized positioning osteotomy technology to avoid increased bleeding and fatty lung caused by reaming Embolism and other complications.
以上所述实施例仅表达了本发明的几种实施方式，其描述较为具体和详细，但并不能因此而理解为对本发明专利范围的限制。应当指出的是，对于本领域的普通技术人员来说，在不脱离本发明构思的前提下，还可以做出若干变形和改进，这些都属于本发明的保护范围。因此，本发明专利的保护范围应以所附权利要求为准。The above-mentioned embodiments only express several implementation modes of the present invention, and the description thereof is relatively specific and detailed, but should not be construed as limiting the patent scope of the present invention. It should be pointed out that those skilled in the art can make several modifications and improvements without departing from the concept of the present invention, and these all belong to the protection scope of the present invention. Therefore, the protection scope of the patent for the present invention should be based on the appended claims.
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201510195746.7ACN104758028B (en) | 2015-04-22 | 2015-04-22 | Individualized osteotomy positioning guide device for distal femur and tibial plateau and use method |
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201510195746.7ACN104758028B (en) | 2015-04-22 | 2015-04-22 | Individualized osteotomy positioning guide device for distal femur and tibial plateau and use method |
| Publication Number | Publication Date |
|---|---|
| CN104758028Atrue CN104758028A (en) | 2015-07-08 |
| CN104758028B CN104758028B (en) | 2017-05-31 |
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201510195746.7AExpired - Fee RelatedCN104758028B (en) | 2015-04-22 | 2015-04-22 | Individualized osteotomy positioning guide device for distal femur and tibial plateau and use method |
| Country | Link |
|---|---|
| CN (1) | CN104758028B (en) |
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