CN104083204B - A kind of tibial tunnel locating device based on personalized navigation template and method thereof - Google Patents
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Abstract
本发明涉及交叉韧带重建手术中一种基于个性化导航模板的胫骨隧道定位装置及其方法,首先采集患者CT和MRI数据,对数据模型进行处理和三维重建,再根据三维模型测量和确定隧道的位置,分割出定位所需要的骨表面并建立导航模板模型,然后通过快速成型技术加工制备出来,最后通过导航模板结合导向器的定位装置进行定位和校验后钻入克氏针。本发明导航模板定位简单易操作,加上导向器的辅助定位校准,防止了因为软组织残留等因素造成的导向模板导管小角度摆动偏差而造成克氏针钻入在隧道内口误差被放大情况,可有效保证定位精度,使手术效果更加可靠。
The invention relates to a tibial tunnel positioning device and method based on a personalized navigation template in cruciate ligament reconstruction surgery. Firstly, the patient's CT and MRI data are collected, the data model is processed and three-dimensionally reconstructed, and then the tunnel is measured and determined according to the three-dimensional model. Position, segment the bone surface required for positioning and establish a navigation template model, then process and prepare it through rapid prototyping technology, and finally use the navigation template combined with the positioning device of the guide for positioning and verification, and then drill into the Kirschner wire. The positioning of the navigation template of the present invention is simple and easy to operate, coupled with the auxiliary positioning and calibration of the guide, it prevents the small-angle swing deviation of the guide template catheter caused by factors such as soft tissue residues from being magnified when the Kirschner wire is drilled into the inner mouth of the tunnel. It can effectively guarantee the positioning accuracy and make the operation effect more reliable.
Description
技术领域technical field
本发明属于计算机辅助医疗手术技术领域,涉及交叉韧带重建时术中胫骨隧道定位导航技术,具体涉及交叉韧带重建时术中一种基于个性化导航模板的胫骨隧道定位装置及其方法。The invention belongs to the technical field of computer-aided medical operations, and relates to an intraoperative tibial tunnel positioning and navigation technology during cruciate ligament reconstruction, in particular to an intraoperative tibial tunnel positioning device and method based on a personalized navigation template during cruciate ligament reconstruction.
背景技术Background technique
随着交通科技的发展和体育竞技水平的提高,高能量损伤而导致膝关节交叉韧带撕裂的情况不断增加。膝交叉韧带对维持膝关节运动稳定性至关重要,若得不到有效修复可能导致半月板损伤,软骨磨损,加速膝关节退行性变和骨性关节炎等严重后果,然而因其自身的生物环境和供血特点等原因,膝交叉韧带自愈能力极差,因此手术重建成为了修复膝交叉韧带损伤的主要手段和方法,根据调查数据显示,美国每年约有10万例膝交叉韧带损伤行韧带重建术。With the development of transportation technology and the improvement of sports competition level, the cases of knee cruciate ligament tear caused by high energy injury continue to increase. The cruciate ligament of the knee is very important to maintain the stability of the knee joint. If it is not repaired effectively, it may lead to serious consequences such as meniscus damage, cartilage wear, accelerated knee degeneration and osteoarthritis. However, due to its own biological Due to environmental and blood supply characteristics, the self-healing ability of the knee cruciate ligament is extremely poor, so surgical reconstruction has become the main means and method for repairing knee cruciate ligament injuries. According to survey data, there are about 100,000 knee cruciate ligament injuries in the United States every year. reconstructive surgery.
关节镜下膝交叉韧带重建技术因其术中组织创伤小和感染率低,术后无明显并发症且康复速度快等优点而成为最为流行的手术方式,但文献显示其手术成功率仅有65%~90%,翻修率高达10%~20%,而不正确的隧道位置是造成手术失败率高的主要原因之一。Arthroscopic knee cruciate ligament reconstruction has become the most popular surgical method due to its advantages of less tissue trauma and low infection rate, no obvious postoperative complications and fast recovery, but the literature shows that its success rate is only 65%. % to 90%, the revision rate is as high as 10% to 20%, and the incorrect tunnel position is one of the main reasons for the high failure rate.
现有技术中主要有如下几种辅助膝关节交叉韧带重建时隧道定位的方法:In the prior art, there are mainly the following methods for assisting tunnel positioning during cruciate ligament reconstruction of the knee joint:
1、专利授权公告号为CN101919720A所述膝关节前、后交叉韧带股骨侧隧道定位器,该导向器在关节镜下根据骨性标志、韧带残端和相关组织结构为参考粗略确定隧道位置并进行钻孔。由于个体化差异,每个人的骨骼形态尺寸和韧带的解剖位置有较大的差别,同时关节镜视野下的膝关节组织结构形态与实际情况存在较大差异,所以该隧道定位方法的准确性主要依赖于术中医生的经验和操作,隧道定位精度以及方向不可控。1. The patent authorization announcement number is CN101919720A described the anterior and posterior cruciate ligament femoral side tunnel locator of the knee joint. The guider roughly determines the tunnel position and performs drilling. Due to individual differences, there are large differences in the shape and size of bones and the anatomical position of ligaments for each person. At the same time, there is a large difference between the structure of the knee joint under the arthroscopic view and the actual situation. Therefore, the accuracy of the tunnel positioning method mainly depends on Depending on the experience and operation of the surgeon during the operation, the positioning accuracy and direction of the tunnel cannot be controlled.
2、专利授权公告号为CN101518447A所述一种提高脊柱外科手术计算机导航系统精度的方法,脊柱、手术工具器械以及导航智能器械上安装有示踪器,注册后被导航系统识别并确立它们之间的位置,通过摄像机获取患者手术区域的位置,术前或术中获取手术区域的数字影像并导入导航系统并进行图像注册,导航系统实时跟踪手术过程并同步显示来辅助隧道定位。该导航系统设备复杂且价格昂贵,设备连接和注册过程耗时,学习曲线长,手术时间长,摄像机和手术区域之前不能有遮挡,影响手术操作,同时存在影像“漂移”等现象,对手术精度造成误差。2. The patent authorization announcement number is CN101518447A, a method for improving the accuracy of a computerized navigation system for spinal surgery. Tracers are installed on the spine, surgical tools and instruments, and intelligent navigation instruments. After registration, they are recognized by the navigation system and establish the relationship between them. The location of the operation area of the patient is obtained through the camera, and the digital image of the operation area is obtained before or during the operation and imported into the navigation system for image registration. The navigation system tracks the operation process in real time and displays it synchronously to assist tunnel positioning. The navigation system equipment is complicated and expensive, the device connection and registration process is time-consuming, the learning curve is long, the operation time is long, the camera and the operation area cannot be blocked, which affects the operation, and there are phenomena such as image "drift", which affects the accuracy of the operation. cause error.
3、专利授权公告号为CN101390773A所述一种可用于椎弓根定位的导航模板的制作方法,该导航模板利用CT或者MRI采集原始数据并导入计算机中建立椎骨三维模型,对椎弓根进钉通道进行三维分析后反向建立虚拟进钉导向模板,并利用快速成型制作出来。该导航模板只依靠椎骨的表面解剖形态进行定位,缺乏相应的定位评估机构,定位精度低,模板的固定依靠手工按压,入钉过程中电钻的震动可能造成模板定位偏差,只适用于椎弓根定位。3. The patent authorization announcement number is CN101390773A, a method for making a navigation template that can be used for pedicle positioning. The navigation template uses CT or MRI to collect raw data and import it into the computer to establish a three-dimensional model of the vertebra. After the three-dimensional analysis of the channel, a virtual nail-guiding template is reversely established, and it is manufactured by rapid prototyping. The navigation template only relies on the surface anatomy of the vertebrae for positioning, lacks a corresponding positioning evaluation mechanism, and has low positioning accuracy. The template is fixed by manual pressing, and the vibration of the electric drill during the nail insertion process may cause template positioning deviations. It is only suitable for pedicles. position.
4、专利授权公告号为CN101816590A所述一种人体骨科手术导航模板的制作方法及其阴模,该方法采集患者手术的骨原始数据并导入计算机中建立骨三维模型,设定好螺钉定位杆并提取螺钉定位附近的骨曲面,建立反向导航模板模型并将阴模三维模型打印出来,将生物材料灌注到阴模中制备出具有生物相容性的导航模板。对于进钉导航模板,其生物性要求不高,该方法制备的具生物相容性的导航模板工序复杂且制备费用昂贵,实用性不足。4. The patent authorization announcement number is CN101816590A, a method for making a navigation template for human orthopedic surgery and its negative mold. This method collects the original bone data of the patient's operation and imports it into the computer to establish a three-dimensional bone model, sets the screw positioning rod and The bone surface near the screw location is extracted, the reverse navigation template model is established and the three-dimensional model of the female mold is printed out, and the biological material is poured into the female mold to prepare a biocompatible navigation template. As for the nail-in navigation template, its biological requirements are not high, and the biocompatible navigation template prepared by this method is complicated in process and expensive in preparation cost, and its practicability is insufficient.
综上所述,传统的关节镜结合导向器辅助膝关节交叉韧带重建时隧道定位未考虑到人体骨骼个体化差异,手术的成败取决于医生的经验和操作,而影像导航技术昂贵的设备和复杂的操作增加了手术的成本、学习曲线和手术时间,影像“漂移”等将对手术精度造成一定影响,现有的导航模板术中定位精度无法评估,其稳定性和安全性不足,因此,当前亟需提出一种快速高精度的个性化辅助交叉韧带胫骨隧道定位装置及其方法。To sum up, traditional arthroscopy combined with guides to assist knee cruciate ligament reconstruction does not take into account the individual differences in human skeleton tunnel positioning. The success or failure of the operation depends on the experience and operation of the doctor, while the image navigation technology is expensive and complex. The operation increases the cost, learning curve and operation time of the operation, and the image "drift" will have a certain impact on the accuracy of the operation. The positioning accuracy of the existing navigation template cannot be evaluated, and its stability and safety are insufficient. Therefore, the current There is an urgent need to propose a rapid and high-precision personalized auxiliary cruciate ligament tibial tunnel positioning device and method.
发明内容Contents of the invention
基于上述的情况下,本发明提供一种成本低、精度高、使用方便简单的个性化辅助前交叉韧带隧道定位的工具和方法,以解决目前现有技术中个性化隧道解剖定位困难的问题。Based on the above circumstances, the present invention provides a low-cost, high-precision, easy-to-use personalized auxiliary tool and method for positioning the anterior cruciate ligament tunnel, so as to solve the problem of difficulty in the anatomical positioning of the personalized tunnel in the current prior art.
为解决上述技术问题,本发明所采取的技术方案是:一种基于个性化导航模板的胫骨隧道定位装置,包括导航模板和导向器,In order to solve the above technical problems, the technical solution adopted by the present invention is: a tibial tunnel positioning device based on a personalized navigation template, including a navigation template and a guide,
所述的导航模板包含一个内表面与接触的骨表面的解剖形态一致的基座,基座上设计有对应于隧道外口中心的导向管,导向管的中心线与隧道中心线同轴,数量与重建隧道数一致;导向管内设有内螺纹;基座上开有若干通孔,用于检验导航模板的定位以及固定导航模板;The navigation template includes a base whose inner surface is consistent with the anatomical shape of the contacted bone surface, and a guide tube corresponding to the center of the outer opening of the tunnel is designed on the base, the centerline of the guide tube is coaxial with the centerline of the tunnel, and the number Consistent with the number of reconstructed tunnels; there are internal threads in the guide pipe; several through holes are opened on the base for checking the positioning of the navigation template and fixing the navigation template;
所述的导向器包括内杆、外杆、金属导管和测量尺;内杆一端为定位钩,另一端为截面为键槽形状的弧形定位臂,定位臂上设置有显示导向器张角的刻度;外杆的上端与内杆的定位臂相适应,是一截面为键槽形状的弧形滑槽,通过第一锁紧螺钉与定位臂连接;外杆下端连接在一中空的套筒中部一侧;金属导管一端设有与导向管内螺纹相应的外螺纹,金属导管穿过套筒后与导向管连接,套筒通过第二锁紧螺钉将金属导管固定;测量尺是一端为尖状的金属杆,金属杆上设置有对应于定位钩至尖端距离的刻度,用于测量隧道的距离。The guide includes an inner rod, an outer rod, a metal conduit and a measuring ruler; one end of the inner rod is a positioning hook, and the other end is an arc-shaped positioning arm whose section is in the shape of a keyway, and the positioning arm is provided with a scale showing the opening angle of the guide ; The upper end of the outer rod is adapted to the positioning arm of the inner rod, which is an arc-shaped chute with a keyway shape in cross section, and is connected with the positioning arm through the first locking screw; the lower end of the outer rod is connected to one side of the middle part of a hollow sleeve ; One end of the metal conduit is provided with an external thread corresponding to the internal thread of the guide tube, and the metal conduit is connected to the guide tube after passing through the sleeve, and the sleeve fixes the metal conduit through the second locking screw; the measuring ruler is a pointed metal rod at one end , the metal rod is provided with a scale corresponding to the distance from the positioning hook to the tip, which is used to measure the distance of the tunnel.
所述的第一锁紧螺钉安装在外杆上端内侧的平台上,第二锁紧螺钉安装在套筒下部的平台上。The first locking screw is installed on the platform inside the upper end of the outer rod, and the second locking screw is installed on the platform at the lower part of the sleeve.
所述的基座壁厚为2~3mm,导向管内螺纹的公称直径为4mm,中空套筒内径为4mm,长度为30mm,金属导管外螺纹的公称直径为4mm,金属导管内径为2mm,壁厚为1mm,测量尺直径为3.4mm。The wall thickness of the base is 2-3mm, the nominal diameter of the internal thread of the guide pipe is 4mm, the internal diameter of the hollow sleeve is 4mm, and the length is 30mm, the nominal diameter of the external thread of the metal conduit is 4mm, the internal diameter of the metal conduit is 2mm, and the wall thickness is 1mm, and the diameter of the measuring ruler is 3.4mm.
一种与所述的基于个性化导航模板的胫骨隧道定位装置相适应的定位方法,包括以下步骤:A positioning method adapted to the described tibial tunnel positioning device based on a personalized navigation template, comprising the following steps:
步骤一:采集患者膝关节伸直位CT数据,提取出轮廓清晰的胫骨和股骨点数据并导出;Step 1: Collect the CT data of the patient’s knee joint in straight position, extract and export the tibial and femoral point data with clear outlines;
步骤二:采集患者膝关节伸直位MRI数据,提取出包含胫骨、股骨、半月板、软骨和交叉韧带的点数据并导出;Step 2: Collect the MRI data of the patient's knee joint in straight position, extract and export point data including the tibia, femur, meniscus, cartilage and cruciate ligament;
步骤三:对步骤一和步骤二获得的数据进行采样、删除杂点、降噪和光顺处理,分别进行三维重建后通过注册获得带有半月板、软骨和交叉韧带组织结构的股骨和胫骨膝关节模型;Step 3: Sampling, removing noise, denoising and smoothing the data obtained in Step 1 and Step 2, respectively performing 3D reconstruction and obtaining femoral and tibial knee joints with meniscus, cartilage and cruciate ligament tissue structures through registration Model;
步骤四:若患者左右膝关节组织结构无畸变且对称性良好,则根据健侧膝关节三维模型确定健侧交叉韧带附丽点解剖位置并进行测量,然后结合健侧的测量数据和患侧三维模型两者来确定患侧关节胫骨隧道内口位置;否则直接根据患侧膝关节三维模型并结合经验数据确定胫骨隧道内口位置;Step 4: If the patient’s left and right knee joints have no distortion and good symmetry, then determine the anatomical position of the attachment point of the cruciate ligament on the healthy side according to the 3D model of the healthy side’s knee joint and measure it, and then combine the measurement data of the healthy side with the 3D model of the affected side Both are used to determine the position of the inner opening of the tibial tunnel on the affected side; otherwise, the position of the inner opening of the tibial tunnel is determined directly based on the three-dimensional model of the knee joint on the affected side and combined with empirical data;
步骤五:根据步骤四所确定的隧道内口位置,进行虚拟隧道三维设计和分析,并分割出定位所需要的骨表面,在工业三维CAD软件中建立导航模板模型,然后通过快速成型技术加工制备出来;Step 5: According to the position of the tunnel inner mouth determined in Step 4, carry out 3D design and analysis of the virtual tunnel, and segment the bone surface required for positioning, establish a navigation template model in the industrial 3D CAD software, and then process and prepare it by rapid prototyping technology come out;
步骤六:导航模板辅助导向器定位,同时通过导向器的测量尺检验导航模板定位精度,若误差超标可微调导航模板直到满足手术要求。Step 6: The navigation template assists in the positioning of the guide. At the same time, the positioning accuracy of the navigation template is checked by the measuring ruler of the guide. If the error exceeds the standard, the navigation template can be fine-tuned until it meets the surgical requirements.
所述的步骤四中,胫骨交叉韧带附丽点测量方法为在计算机三维模型横断面方向采用胫骨交叉韧带附丽点到胫骨前边缘和内侧边缘的距离分别占胫骨前后边缘和内外边缘总距离的百分比的方法;In the described step four, the tibial cruciate ligament attachment point measurement method is to use the tibial cruciate ligament attachment point to the tibial anterior edge and the inner edge of the distance of the tibial anterior edge and the percentage of the total distance of the inner and outer edges in the cross-sectional direction of the computer three-dimensional model. method;
所述的步骤五中,虚拟隧道三维设计和分析主要包括在计算机中建立虚拟隧道,然后基于膝关节运动学从伸直位屈曲膝关节成若干不同角度后分析设计的隧道内口位置是否会造成韧带重建后发生撞击以及“雨刷效应”和“橡皮筋效应”,测量隧道的长度和方向是否合理;所述的快速成型技术为熔融沉积成型或光固化成型或选择性激光烧结。In Step 5, the three-dimensional design and analysis of the virtual tunnel mainly includes establishing a virtual tunnel in the computer, and then analyzing whether the designed position of the inner mouth of the tunnel will cause a Impact and "wiper effect" and "rubber band effect" after ligament reconstruction, measure whether the length and direction of the tunnel are reasonable; the rapid prototyping technology described is fused deposition modeling or photocuring molding or selective laser sintering.
所述的步骤六包括以下具体步骤:Described step six includes the following specific steps:
(i)使用导航模板贴合于骨表面,基于骨骼的几何形态初步定位;(i) Use the navigation template to fit on the bone surface, and perform preliminary positioning based on the geometry of the bone;
(ii)导航模板和金属导管通过螺纹固定连接,外杆与金属导管在套筒处连接,引导膝关节内导向器的定位钩初步定位,关节镜下观察定位钩的位置,微调模板使定位钩达到理想位置;(ii) The navigation template and the metal catheter are fixedly connected by threads, and the outer rod and the metal catheter are connected at the sleeve to guide the preliminary positioning of the positioning hook of the guide in the knee joint. reach the ideal position;
(iii)保持步骤(ii)中定位钩的位置不变,卸下金属导管,通过测量尺分别测量隧道外口中心点和基座上若干通孔中心点至少四个不同点到定位钩的距离,并将其与计算机测量值进行对比,若保持一致则说明导航模板定位准确;(iii) Keep the position of the positioning hook in step (ii) unchanged, remove the metal conduit, and use a measuring ruler to measure the distance from the center point of the outer opening of the tunnel and the center points of several through holes on the base to at least four different points to the positioning hook , and compare it with the measured value of the computer, if they are consistent, it means that the positioning of the navigation template is accurate;
(iv)使用短克氏针打入基座上通孔固定导航模板,避免克氏针钻入胫骨时抖动造成偏差;(iv) Use a short Kirschner wire to drive into the through hole on the base to fix the navigation template, so as to avoid deviation caused by vibration when the Kirschner wire drills into the tibia;
(v)取下测量尺,再次安装上金属导管引导钻入克氏针。(v) Remove the measuring ruler and install the metal catheter again to guide the drilling into the Kirschner wire.
本发明还要求保护所述的定位装置在前后交叉韧带单束或双束重建手术中胫骨隧道定位中的应用。The present invention also claims to protect the application of the positioning device in tibial tunnel positioning in single-bundle or double-bundle reconstruction of anterior and posterior cruciate ligaments.
本发明提出的一种基于个性化导航模板的胫骨隧道定位装置及其方法,结合了计算机成像重构技术和快速成型技术,充分利用了CT和MRI两者的成像优势,可获得带有半月板、软骨、交叉韧带组织结构和轮廓清晰的胫骨、股骨的完整膝关节模型,为虚拟隧道精确测量和定位提供可靠的参考。基于骨骼解剖形态和术前隧道虚拟分析完成个性化模板设计,术前通过快速成型技术制造出来,使得定位简单易操作,可有效提高手术的成功率和缩短手术时间。加上导向器的辅助定位校准,防止了因为软组织残留等因素造成的导向模板导管小角度摆动偏差而造成克氏针钻入在隧道内口误差被放大情况,有效保证定位精度,使手术效果更加可靠。A tibial tunnel positioning device and method based on a personalized navigation template proposed by the present invention combines computer imaging reconstruction technology and rapid prototyping technology, fully utilizes the imaging advantages of both CT and MRI, and can obtain , cartilage, cruciate ligament tissue structure and a complete knee joint model with clear outlines of tibia and femur provide a reliable reference for accurate measurement and positioning of the virtual tunnel. Based on the anatomical shape of the bone and the virtual analysis of the preoperative tunnel, the personalized template design is completed, and the preoperative rapid prototyping technology is used to make the positioning simple and easy to operate, which can effectively improve the success rate of the operation and shorten the operation time. Coupled with the auxiliary positioning and calibration of the guide, it prevents the small-angle swing deviation of the guide template catheter caused by factors such as soft tissue residues from being magnified when the Kirschner wire drills into the inner mouth of the tunnel, effectively ensuring the positioning accuracy and making the operation effect more effective. reliable.
附图说明Description of drawings
图1为本发明所述的导航模板制备工艺流程图。Fig. 1 is a flow chart of the preparation process of the navigation template according to the present invention.
图2为本发明所述的定位装置整体示意图。Fig. 2 is an overall schematic diagram of the positioning device of the present invention.
图3为本发明所述的导航模板示意图。Fig. 3 is a schematic diagram of a navigation template according to the present invention.
图4为本发明所述的导向器装配示意图。Fig. 4 is a schematic diagram of the assembly of the guider according to the present invention.
图5为本发明所述的导向器内杆示意图。Fig. 5 is a schematic diagram of the inner rod of the guide according to the present invention.
图6为本发明所述的导向器外杆的第一示意图。Fig. 6 is a first schematic view of the outer rod of the guide according to the present invention.
图7为本发明所述的导向器外杆的第二示意图。Fig. 7 is a second schematic diagram of the outer rod of the guide according to the present invention.
图8为本发明所述的内杆定位臂截面图。Fig. 8 is a sectional view of the inner rod positioning arm according to the present invention.
图9为本发明所述的金属导管示意图。Fig. 9 is a schematic diagram of the metal conduit according to the present invention.
图10为本发明所述的测量尺示意图。Fig. 10 is a schematic diagram of the measuring ruler of the present invention.
具体实施方式detailed description
下面结合实施例及其附图详细说明本发明所述的一种基于个性化导航模板的胫骨隧道定位装置及其方法,但本发明的保护范围不局限于下述的实施例。A tibial tunnel positioning device and method based on a personalized navigation template according to the present invention will be described in detail below in conjunction with the embodiments and accompanying drawings, but the scope of protection of the present invention is not limited to the following embodiments.
如图1所示,本发明导航模板的具体制备工艺流程依照箭头方向进行。As shown in FIG. 1 , the specific manufacturing process flow of the navigation template of the present invention is carried out in the direction of the arrow.
如图2所示,本发明导航模板1辅助导向器2隧道内口位置初步定位,在关节镜下观察定位情况并微调精确定位,金属导筒5引导克氏针钻入,有效防止外口导向管12小角度误差而造成内口位置较大的偏差。As shown in Figure 2, the navigation template 1 of the present invention assists the guider 2 in the initial positioning of the inner opening of the tunnel, observes the positioning situation under the arthroscope and fine-tunes the precise positioning, and the metal guide cylinder 5 guides the Kirschner wire to drill in, effectively preventing the outer opening from being guided The small angle error of the tube 12 causes a large deviation in the position of the inner opening.
如图3所示,本发明的双束重建前交叉韧带胫骨隧道定位导航模板1,包括内表面与骨骼表面几何形态一致的基座11、对应于隧道外口中心带有内螺纹13的导向管12和若干通孔14。As shown in Fig. 3, the positioning navigation template 1 of the tibial tunnel for double-bundle reconstruction of the anterior cruciate ligament of the present invention includes a base 11 whose inner surface is geometrically consistent with the bone surface, and a guide tube with an internal thread 13 corresponding to the center of the outer opening of the tunnel. 12 and several through holes 14.
如图4所示,本发明导向器2,包含内杆3、外杆4、金属导管5、第一锁紧螺钉7和第二锁紧螺钉8。As shown in FIG. 4 , the guide 2 of the present invention includes an inner rod 3 , an outer rod 4 , a metal conduit 5 , a first locking screw 7 and a second locking screw 8 .
如图5所示,本发明导向器2的内杆3,包括定位钩31、截面形状为键槽形的弧形定位臂32及其刻度33。As shown in FIG. 5 , the inner rod 3 of the guide 2 of the present invention includes a positioning hook 31 , an arc-shaped positioning arm 32 with a keyway-shaped cross section and a scale 33 thereof.
如图6和图7所示,本发明导向器2的外杆4,包括一端为截面为键槽形状的弧形滑槽41、滑槽41内侧上端平台42、另一端为中空套筒43,套筒43下部平台44。As shown in Figures 6 and 7, the outer rod 4 of the guide 2 of the present invention includes an arc chute 41 with a keyway shape in section at one end, an upper platform 42 on the inner side of the chute 41, and a hollow sleeve 43 at the other end. Bottom platform 44 of cylinder 43 .
如图8所示,本发明内杆3的定位臂32的剖面图。As shown in FIG. 8 , a cross-sectional view of the positioning arm 32 of the inner rod 3 of the present invention.
如图9所示,本发明的金属导管5,一端为公称直径为4mm的螺纹外螺纹51。As shown in FIG. 9 , the metal conduit 5 of the present invention has a threaded external thread 51 with a nominal diameter of 4 mm at one end.
如图10所示,本发明测量尺6为一端为尖状61,直径为3.4mm的金属杆,杆上设置有对应于定位钩至尖端距离的测量刻度62,可用于测量隧道的距离。As shown in Figure 10, the measuring ruler 6 of the present invention is a metal rod with a pointed end 61 and a diameter of 3.4 mm. The rod is provided with a measuring scale 62 corresponding to the distance from the positioning hook to the tip, which can be used to measure the distance of the tunnel.
实施例一Embodiment one
本发明辅助前交叉韧带单束重建胫骨隧道定位的装置和方法步骤如下:The steps of the device and method for assisting single-bundle reconstruction of the anterior cruciate ligament in tibial tunnel positioning according to the present invention are as follows:
步骤一:采集患者膝关节伸直位CT数据,采用mimics软件提取出轮廓清晰的胫骨和股骨点数据并导出。Step 1: Collect the CT data of the patient's knee joint in straight position, and use the mimics software to extract and export the tibial and femoral point data with clear outlines.
步骤二:采集患者膝关节伸直位MRI数据,采用mimics软件提取出包含胫骨、股骨、半月板、软骨和交叉韧带的点数据并导出。Step 2: Collect the MRI data of the patient's knee joint in straight position, use mimics software to extract point data including tibia, femur, meniscus, cartilage and cruciate ligament and export it.
步骤三:利用imageware对步骤一和步骤二获得的数据进行采样、删除杂点、降噪和光顺处理,分别进行三维重建后通过注册获得带有半月板、软骨、交叉韧带组织结构的股骨和胫骨膝关节模型。Step 3: Use imageware to sample the data obtained in Step 1 and Step 2, remove noise points, denoise and smoothen, perform 3D reconstruction respectively, and obtain the femur and tibia with the tissue structure of meniscus, cartilage and cruciate ligament through registration Knee model.
步骤四:在计算机三维模型横断面方向,采用胫骨交叉韧带附丽点到胫骨前边缘和内侧边缘的距离分别占胫骨前后边缘和内外边缘总距离的百分比的方法测量健侧交叉韧带附丽点解剖位置。韧带附丽点距离胫骨前边缘和内侧边缘的距离分别为前后距离的42.8%和内外距离的45.7%。结合健侧的测量数据和患侧三维模型两者来确定患侧关节胫骨隧道内口位置。Step 4: In the cross-sectional direction of the computer three-dimensional model, the anatomical position of the attachment point of the cruciate ligament on the healthy side is measured by the percentage of the distance from the attachment point of the tibial cruciate ligament to the anterior edge and the inner edge of the tibia as a percentage of the total distance between the anterior and posterior edges of the tibia and the inner and outer edges of the tibia. The distance between the ligament attachment point and the anterior border and medial border of the tibia was 42.8% of the anteroposterior distance and 45.7% of the medial and medial distance. Combining the measurement data of the healthy side and the three-dimensional model of the affected side to determine the position of the inner opening of the tibial tunnel of the affected side.
步骤五:根据步骤四所确定的隧道位置,在计算机中虚拟设计隧道,并基于膝关节运动学从伸直位屈曲膝关节成若干不同角度过程中隧道内口位置不会造成韧带重建后发生撞击以及“雨刷效应”和“橡皮筋效应”,隧道的长度为35mm,与胫骨平台的夹角分别为52°。分割出定位所需要的骨表面,在工业PRO-E软件中建立三维反向导航模板1模型,通过选择性激光烧结快速成型技术加工制备出来。Step 5: According to the position of the tunnel determined in step 4, design the tunnel virtually in the computer, and based on the kinematics of the knee joint, the position of the inner mouth of the tunnel will not cause impact after ligament reconstruction. As well as the "wiper effect" and "rubber band effect", the length of the tunnel is 35mm, and the included angle with the tibial plateau is 52°, respectively. The bone surface required for positioning was segmented, and a three-dimensional reverse navigation template 1 model was established in the industrial PRO-E software, which was processed and prepared by selective laser sintering rapid prototyping technology.
步骤六:导航模板1辅助导向器2定位,同时通过导向器2的测量尺6检验校核导航模板1定位。Step 6: The navigation template 1 assists the guide 2 in positioning, and at the same time checks the positioning of the navigation template 1 through the measuring ruler 6 of the guide 2 .
所述的导航模板1包含一个内表面与接触的骨表面的解剖形态一致基座11,其壁厚为2mm;基座11上设计有对应于隧道外口中心的导向管12,其中心线与隧道中心线同轴,数量与重建隧道数一致;导向管12内有公称直径为4mm的内螺纹13;基座11上开有若干通孔14,用于检验导航模板1的定位以及固定导航模板1。Described navigation template 1 comprises a base 11 whose inner surface is consistent with the anatomical form of the contacted bone surface, and its wall thickness is 2 mm; a guide tube 12 corresponding to the center of the outer opening of the tunnel is designed on the base 11, and its centerline is in line with The center line of the tunnel is coaxial, and the number is consistent with the number of reconstructed tunnels; the guide pipe 12 has an internal thread 13 with a nominal diameter of 4 mm; a number of through holes 14 are opened on the base 11, which are used to check the positioning of the navigation template 1 and fix the navigation Template 1.
导向器2由内杆3、外杆4、金属导管5和测量尺6组成。内杆3一端为定位钩31,另一端为截面为键槽形状的弧形定位臂32,定位臂32张角为50°,定位钩31和定位臂32通过圆杆连接。外杆4一端为截面为键槽形状的弧形滑槽41,在滑槽41内侧上端有一平台42安装有第一锁紧螺钉7,另一端为中空套筒43对称分布于滑槽41中心线两侧,内径为4mm,长度为30mm,套筒43下部有一平台44安装有两个第二锁紧螺钉8。金属导管5一端有公称直径为4mm的外螺纹51,金属导管5内径为2mm,壁厚为1mm。测量尺6为一端为尖状61,直径为3.4mm的金属杆,杆上设置有对应于定位钩31至尖端距离的测量刻度62,可用于测量隧道的距离。The guide 2 is composed of an inner rod 3 , an outer rod 4 , a metal conduit 5 and a measuring ruler 6 . Inner rod 3 one end is positioning hook 31, and the other end is the arc positioning arm 32 of keyway shape in section, and positioning arm 32 opening angles are 50 °, and positioning hook 31 and positioning arm 32 are connected by round bar. One end of the outer rod 4 is an arc-shaped chute 41 with a keyway shape in cross section. There is a platform 42 on the inner upper end of the chute 41 on which the first locking screw 7 is installed, and the other end is a hollow sleeve 43 symmetrically distributed on both sides of the center line of the chute 41. On the side, the inner diameter is 4mm, and the length is 30mm. There is a platform 44 on the lower part of the sleeve 43 and two second locking screws 8 are installed. One end of the metal conduit 5 has an external thread 51 with a nominal diameter of 4mm, the inner diameter of the metal conduit 5 is 2mm, and the wall thickness is 1mm. Measuring ruler 6 is a pointed 61 at one end and a metal rod with a diameter of 3.4mm. The rod is provided with a measuring scale 62 corresponding to the distance from the positioning hook 31 to the tip, which can be used to measure the distance of the tunnel.
步骤六的具体使用方法为:The specific usage method of step 6 is:
(i)使用导航模板1贴合于骨表面,基于骨骼的几何形态初步定位。(i) Use the navigation template 1 to fit on the bone surface, and perform preliminary positioning based on the geometry of the bone.
(ii)导航模板1和金属导管5通过内螺纹13和外螺纹51固定连接,外杆4套筒43与金属导管5同轴连接,引导膝关节内导向器2的定位钩31初步定位,关节镜下观察定位钩31的位置,微调模板使定位钩31达到理想位置。(ii) The navigation template 1 and the metal conduit 5 are fixedly connected through the internal thread 13 and the external thread 51, and the sleeve 43 of the outer rod 4 is coaxially connected with the metal conduit 5 to guide the positioning hook 31 of the inner guide 2 of the knee joint for preliminary positioning, and the joint Observe the position of the positioning hook 31 under the microscope, and fine-tune the template to make the positioning hook 31 reach the ideal position.
(iii)保持步骤(ii)中定位钩31的位置不变,卸下金属导管5,通过测量尺6分别测量隧道外口中心点和导航模板1上若干通孔14中心点至少四个不同点到定位钩31尖端距离,并将其计算机测量值进行对比,若保持一致则说明导航模板1定位准确。(iii) Keep the position of the positioning hook 31 in step (ii) unchanged, remove the metal conduit 5, and measure at least four different points at the center point of the outer mouth of the tunnel and the center points of several through holes 14 on the navigation template 1 by measuring ruler 6 The distance to the tip of the positioning hook 31 is compared with the measured values by the computer. If they are consistent, it means that the positioning of the navigation template 1 is accurate.
(iv)使用短克氏针打入基座11通孔14固定导航模板1,避免克氏针钻入胫骨时抖动造成偏差。(iv) Use a short Kirschner wire to drive into the through hole 14 of the base 11 to fix the navigation template 1, so as to avoid deviation caused by shaking when the Kirschner wire is drilled into the tibia.
(v)取下测量尺6,再次安装上金属导管5引导钻入克氏针。(v) Take off the measuring ruler 6 and install the metal conduit 5 again to guide the drilling into the Kirschner wire.
实施例二Embodiment two
本发明辅助前交叉韧带双束重建胫骨隧道定位的装置和方法步骤如下:The steps of the device and method for assisting the positioning of the tibial tunnel for double-bundle reconstruction of the anterior cruciate ligament of the present invention are as follows:
步骤一:采集患者膝关节伸直位CT数据,采用mimics软件提取出轮廓清晰的胫骨和股骨点数据并导出。Step 1: Collect the CT data of the patient's knee joint in straight position, and use the mimics software to extract and export the tibial and femoral point data with clear outlines.
步骤二:采集患者膝关节伸直位MRI数据,采用mimics软件提取出包含胫骨、股骨、半月板、软骨和交叉韧带的点数据并导出。Step 2: Collect the MRI data of the patient's knee joint in straight position, use mimics software to extract point data including tibia, femur, meniscus, cartilage and cruciate ligament and export it.
步骤三:利用geomagicstudio对步骤一和步骤二获得的数据进行采样、删除杂点、降噪和光顺处理,分别进行三维重建后通过注册获得带有半月板、软骨、交叉韧带组织结构的股骨和胫骨膝关节模型。Step 3: Use geomagicstudio to sample the data obtained in step 1 and step 2, remove noise points, denoise and smoothen, perform 3D reconstruction respectively, and obtain femur and tibia with meniscus, cartilage and cruciate ligament tissue structure through registration Knee model.
步骤四:在计算机三维模型横断面方向,采用胫骨交叉韧带附丽点到胫骨前边缘和内侧边缘的距离分别占胫骨前后边缘和内外边缘总距离的百分比的方法测量健侧交叉韧带附丽点解剖位置。前内侧束附丽点距离胫骨前边缘和内侧边缘的距离分别为前后距离的37.3%和内外距离的46.2%,后外侧束附丽点距离胫骨前边缘和内侧边缘的距离分别为前后距离的50.4%和内外距离的51.1%。结合健侧的测量数据和患侧三维模型两者来确定患侧关节胫骨隧道内口位置。Step 4: In the cross-sectional direction of the computer three-dimensional model, the anatomical position of the attachment point of the cruciate ligament on the healthy side is measured by the percentage of the distance from the attachment point of the tibial cruciate ligament to the anterior edge and the inner edge of the tibia as a percentage of the total distance between the anterior and posterior edges of the tibia and the inner and outer edges of the tibia. The distance between the anteromedial bundle attachment point and the anterior border and the medial edge of the tibia is 37.3% of the anteroposterior distance and 46.2% of the medial and medial distance, and the distance between the posterolateral bundle attachment point and the anterior border and the medial edge of the tibia is 50.4% and 51.1% of the inside-outside distance. Combining the measurement data of the healthy side and the three-dimensional model of the affected side to determine the position of the inner opening of the tibial tunnel of the affected side.
步骤五:根据步骤四所确定的隧道位置,在计算机中虚拟设计隧道,并基于膝关节运动学从伸直位屈曲膝关节成若干不同角度过程中隧道内口位置不会造成韧带重建后发生撞击以及“雨刷效应”和“橡皮筋效应”,前内侧束和后外侧束隧道的长度分别为38mm和31mm,与胫骨平台的夹角分别为56°和45°。分割出定位所需要的骨表面,在工业NX-UG软件中建立三维反向导航模板1模型,通过融通沉积快速成型技术加工制备出来。Step 5: According to the position of the tunnel determined in step 4, design the tunnel virtually in the computer, and based on the kinematics of the knee joint, the position of the inner mouth of the tunnel will not cause impact after ligament reconstruction. As well as the "wiper effect" and "rubber band effect", the lengths of the anteromedial and posterolateral tunnels are 38mm and 31mm, respectively, and the angles with the tibial plateau are 56° and 45°, respectively. The bone surface required for positioning is segmented, and a three-dimensional reverse navigation template 1 model is established in the industrial NX-UG software, which is processed and prepared by fusion deposition rapid prototyping technology.
步骤六:导航模板1辅助导向器2定位,同时通过导向器2的测量尺6检验校核导航模板1定位。Step 6: The navigation template 1 assists the guide 2 in positioning, and at the same time checks the positioning of the navigation template 1 through the measuring ruler 6 of the guide 2 .
所述的导航模板1包含一个内表面与接触的骨表面的解剖形态一致基座11,其壁厚为2.5mm;基座11上设计有对应于隧道外口中心的导向管12,其中心线与隧道中心线同轴,数量与重建隧道数一致;导向管12内有公称直径为4mm的内螺纹13;基座11上开有若干通孔14,用于检验导航模板1的定位以及固定导航模板1。The navigation template 1 includes a base 11 whose inner surface is consistent with the anatomical shape of the contacted bone surface, and whose wall thickness is 2.5mm; a guide tube 12 corresponding to the center of the outer opening of the tunnel is designed on the base 11, and its centerline It is coaxial with the center line of the tunnel, and the number is consistent with the number of reconstructed tunnels; the guide tube 12 has internal threads 13 with a nominal diameter of 4mm; the base 11 has a number of through holes 14 for checking the positioning and fixing of the navigation template 1 Navigation template 1.
导向器2由内杆3、外杆4、金属导管5和测量尺6组成。内杆3一端为定位钩31,另一端为截面为键槽形状的弧形定位臂32,定位臂32张角为45°,定位钩31和定位臂32通过圆杆连接。外杆4一端为截面为键槽形状的弧形滑槽41,在滑槽41内侧上端有一平台42安装有第一锁紧螺钉7,另一端为中空套筒43对称分布于滑槽41中心线两侧,内径为4mm,长度为30mm,套筒43下部有一平台44安装有两个第二锁紧螺钉8。金属导管5一端有公称直径为4mm的外螺纹51,金属导管5内径为2mm,壁厚为1mm。测量尺6为一端为尖状61,直径为3.4mm的金属杆,杆上设置有对应于定位钩31至尖端距离的刻度62,可用于测量隧道的距离。The guide 2 is composed of an inner rod 3 , an outer rod 4 , a metal conduit 5 and a measuring ruler 6 . One end of the inner rod 3 is a positioning hook 31, and the other end is an arc positioning arm 32 with a keyway shape in cross section. The 32 opening angles of the positioning arm are 45°, and the positioning hook 31 and the positioning arm 32 are connected by a round bar. One end of the outer rod 4 is an arc-shaped chute 41 with a keyway shape in cross section. There is a platform 42 on the inner upper end of the chute 41 on which the first locking screw 7 is installed, and the other end is a hollow sleeve 43 symmetrically distributed on both sides of the center line of the chute 41. On the side, the inner diameter is 4mm, and the length is 30mm. There is a platform 44 on the lower part of the sleeve 43 and two second locking screws 8 are installed. One end of the metal conduit 5 has an external thread 51 with a nominal diameter of 4mm, the inner diameter of the metal conduit 5 is 2mm, and the wall thickness is 1mm. Measuring ruler 6 is a pointed 61 at one end and a metal rod with a diameter of 3.4mm. The rod is provided with a scale 62 corresponding to the distance from the positioning hook 31 to the tip, which can be used to measure the distance of the tunnel.
步骤六的具体使用方法为:The specific usage method of step 6 is:
(i)使用导航模板1贴合于骨表面,基于骨骼的几何形态初步定位。(i) Use the navigation template 1 to fit on the bone surface, and perform preliminary positioning based on the geometry of the bone.
(ii)导航模板1和金属导管5通过内螺纹13和外螺纹51固定连接,外杆4套筒43与金属导管5同轴连接,引导膝关节内导向器2的定位钩31初步定位,关节镜下观察定位钩31的位置,微调模板使定位钩31达到理想位置。(ii) The navigation template 1 and the metal conduit 5 are fixedly connected through the internal thread 13 and the external thread 51, and the sleeve 43 of the outer rod 4 is coaxially connected with the metal conduit 5 to guide the positioning hook 31 of the inner guide 2 of the knee joint for preliminary positioning, and the joint Observe the position of the positioning hook 31 under the microscope, and fine-tune the template to make the positioning hook 31 reach the ideal position.
(iii)保持步骤(ii)中定位钩31的位置不变,卸下金属导管5,通过测量尺6分别测量隧道外口中心点和导航模板1上若干通孔14中心点至少四个不同点到定位钩31尖端距离,并将其计算机测量值进行对比,若保持一致则说明导航模板1定位准确。(iii) Keep the position of the positioning hook 31 in step (ii) unchanged, remove the metal conduit 5, and measure at least four different points at the center point of the outer mouth of the tunnel and the center points of several through holes 14 on the navigation template 1 by measuring ruler 6 The distance to the tip of the positioning hook 31 is compared with the measured values by the computer. If they are consistent, it means that the positioning of the navigation template 1 is accurate.
(iv)使用短克氏针打入基座11通孔14固定导航模板1,避免克氏针钻入胫骨时抖动造成偏差。(iv) Use a short Kirschner wire to drive into the through hole 14 of the base 11 to fix the navigation template 1, so as to avoid deviation caused by shaking when the Kirschner wire is drilled into the tibia.
(v)取下测量尺6,再次安装上金属导管5引导钻入克氏针。(v) Take off the measuring ruler 6 and install the metal conduit 5 again to guide the drilling into the Kirschner wire.
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