WO2021134165A1 - 胫骨高位截骨的术前规划方法及其导板模型的构建方法 - Google Patents

胫骨高位截骨的术前规划方法及其导板模型的构建方法 Download PDF

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WO2021134165A1
WO2021134165A1 PCT/CN2019/129810 CN2019129810W WO2021134165A1 WO 2021134165 A1 WO2021134165 A1 WO 2021134165A1 CN 2019129810 W CN2019129810 W CN 2019129810W WO 2021134165 A1 WO2021134165 A1 WO 2021134165A1
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planning method
preoperative planning
osteotomy
tibial
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PCT/CN2019/129810
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French (fr)
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刘非
程咏华
杨林
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上海昕健医疗技术有限公司
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Priority to PCT/CN2019/129810 priority Critical patent/WO2021134165A1/zh
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/14—Surgical saws ; Accessories therefor
    • A61B17/15—Guides therefor

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  • the invention relates to the field of medical devices, and in particular to a preoperative planning method for high tibial osteotomy and a method for constructing a guide plate model.
  • High tibial osteotomy is currently used to treat medial compartment osteoarthritis (OA) of the knee joint.
  • HTO can effectively preserve the femur and tibia of the knee joint.
  • HTO is divided into closed wedge-shaped HTO and open wedge-shaped HTO. Since closed wedge-shaped HTO is prone to complications such as atrioventricular syndrome, lateral muscle separation, proximal fibula amputation, limb shortening, and peroneal nerve injury, open wedge-shaped HTO is easier to obtain favorable surgery After the effect, and a large number of clinical studies have proved its efficacy.
  • the doctor In the traditional medial open wedge HTO, the doctor relies on clinical experience and existing measurement tools to perform osteotomy operations, which leads to a high dependence on the doctor’s experience in osteotomy accuracy and correction accuracy. In addition, frequent X-ray fluoroscopy measurements are performed during the operation. , It also increases the radiation hazards of patients and doctors.
  • the purpose of the present invention is to provide a preoperative planning method for high tibial osteotomy and a method for constructing a guide plate model.
  • the present invention provides a preoperative planning method for high tibial osteotomy, which includes the following steps: acquiring two-dimensional or three-dimensional images of the patient's lower limbs and performing three-dimensional reconstruction; selecting the patient's lower limbs and fitting the femoral head spherical center , And select the center point of the ankle joint and the condyle line to obtain the reference plane; select the hinge point at the patient's tibia, based on the reference plane, take the hinge point as the starting point, and define the tibial joint line and the inner tibial contour line as the end point
  • the first intercept line obtain the first intercept guide surface based on the vertical reference plane and pass the first intercept guide line; based on the axis of the hinge point parallel to the direction of the intersection line formed by the intersection of the first intercept guide surface and the reference plane , Rotate the first intercept guide surface by an angle to obtain the second intercept guide surface; complete the osteotomy operation and display it.
  • the line connecting the inner and outer edge points of the tibial plateau is selected as the tibial joint line.
  • the hinge point is the intersection formed by the tibial joint line and the tibial lateral boundary line offset inward by a distance, respectively.
  • the offset distance of the tibial joint line is positively correlated with the length of the tibial joint line.
  • center point of the ankle joint is the projection point of the line connecting the convex point of the distal end of the fibula and the inner convex point of the distal tibia to the plane of the ankle joint.
  • transcondylar line is the line connecting the femoral side internal collateral ligament and the fulcrum of the external collateral ligament.
  • the reference plane direction is the plane direction obtained by the vector product of the lower limb force line and the pelvic condyle line, and both the lower limb force line and the pelvic condyle line are parallel to the reference plane.
  • the present invention provides a method for constructing a high tibial osteotomy guide plate model.
  • the outer contour, osteotomy guide surface and orthopedic angle of the high tibial osteotomy guide plate model are constructed , Obtain the high tibia osteotomy guide plate model.
  • the present invention provides an electronic device, including a memory, a processor, and a computer program stored in the memory and running on the processor.
  • the processor implements high tibial osteotomy when the program is executed. Steps of preoperative planning method.
  • the present invention provides a computer-readable storage medium storing a computer program that, when executed by a processor, realizes the steps of a preoperative planning method for high tibial osteotomy.
  • the invention obtains tibia parameters and parameter points through industrial software, obtains the first intercept guide surface and the second intercept guide surface, obtains the osteotomy surface information in the high tibial osteotomy, and performs surface reconstruction on the three-dimensional image according to the specific surgical operation
  • the operation model is edited, which can effectively eliminate the interference information.
  • the generated surgical plan is designed for the patient's lower limb bones. It is highly targeted.
  • the designed surgical plan has high precision and does not require the doctor to rely too much on the operation during the operation.
  • the patient's condition is judged by experience, thereby increasing the degree of completion of the operation and the postoperative effect.
  • the operation plan is generated through the digital operation result, which reduces the operation risk to a certain extent, shortens the operation time, and greatly improves the operation effect.
  • FIG. 1 is a schematic diagram of the preoperative planning method for high tibial osteotomy of the present invention to determine the reference plane;
  • Fig. 2 is a schematic diagram of determining two osteotomy planes of the preoperative planning method for high tibial osteotomy of the present invention.
  • the preoperative planning method for high tibial osteotomy of the present invention is used to simulate osteotomy and corrective operations before high tibial osteotomy, so as to confirm the accuracy of osteotomy during the operation.
  • Location and related surgical details For ease of description, define the coronal plane, sagittal plane and transverse plane.
  • the preoperative planning method for high tibial osteotomy includes the following steps:
  • the first intercept guide surface P2 is rotated by an angle to obtain the second intercept guide surface P3;
  • the above-mentioned two-dimensional or three-dimensional images may be CT tomographic scan images or MRI scan images, or other images that can achieve the same function, so as to be reconstructed by industrial software.
  • the center of the sphere is the center of the femoral head. point.
  • the smooth surface structure of the femoral head can be selected, and the selected points should be distributed as evenly as possible on the surface of the femoral head.
  • the center point of the ankle joint is the projection point of the line connecting the convex point of the distal fibula and the inner convex point of the distal tibia to the plane of the ankle joint.
  • the transcondylar line AB is the line connecting the femoral side internal collateral ligament and the fulcrum of the external collateral ligament.
  • the line connecting the inner and outer edge points of the tibial plateau is selected as the tibial joint line.
  • Try the tibial plateau usually refers to the plane fitted with the metaphysis and articular surface of the proximal tibia. In the coronal view, obtain the medial contour of the tibia from the inner point of the tibial joint line, and obtain the lateral contour of the tibia from the outer point of the tibial joint line.
  • the hinge point Q is the intersection formed by the tibial joint line and the outer tibial boundary line offset inward by a distance.
  • the offset distance of the tibial joint line is positively related to the length of the tibial joint line, and the offset distance of the tibial joint line needs to conform to the tibial joint line offset curve and pass through the upper proximal part of the fibula.
  • the angle formed between the two osteotomy positions is an obtuse angle, which can be adjusted to separate the tibial tubercle and the tibial plateau.
  • the osteotomy surface of the tibia has been determined.
  • the relevant osteotomy parameters are displayed on the industrial software, and the operation plan is generated.
  • the operation model is obtained by editing the surface reconstruction 3D image according to the specific operation operation, which can effectively eliminate the interference information.
  • the generated operation plan is designed for the patient's lower extremity bone condition, which is highly targeted and the designed operation plan has high accuracy. There is also no need for doctors to rely too much on surgical experience to judge the patient’s condition during the surgical process, thereby increasing the degree of completion of the operation and the postoperative effect.
  • the surgical plan is generated through digital surgical results, which reduces the surgical risk to a certain extent, shortens the operation time, and greatly improves Surgical effect.
  • the outer contour, osteotomy guide surface and orthopedic angle of the high tibial osteotomy guide plate model were constructed to obtain the high tibial osteotomy guide plate model.
  • the osteotomy guide tool 100 is used in high tibial osteotomy, and it is a three-dimensional model reconstructed according to the medical image data of the patient's tibia reversely designed and manufactured by rapid prototyping technology.
  • the steps of the preoperative planning method for high tibial osteotomy can be realized when the processor executes the program. Therefore, the present invention provides an electronic device including a memory, a processor, and a computer program stored on the memory and running on the processor. The steps of the preoperative planning method for achieving high tibial osteotomy when the processor executes the program.
  • the technical solution of the present invention is essentially or the part that contributes to the existing technology or the part of the technical solution can be embodied in the form of a software product.
  • the computer software product is stored in a storage medium and includes a number of instructions to enable A computer device (which may be a personal computer, a server, or a network device, etc.) executes all or part of the steps of the methods in the various embodiments of the present invention.
  • the aforementioned storage media include: U disk, mobile hard disk, read-only memory (ROM, Read-Only Memory), random access memory (RAM, Random Access Memory), magnetic disks or optical disks and other media that can store program codes. .
  • each implementation manner can be implemented by means of software plus a necessary general hardware platform, and of course, it can also be implemented by hardware.
  • the above technical solution essentially or the part that contributes to the existing technology can be embodied in the form of a software product, and the computer software product can be stored in a computer-readable storage medium, such as ROM/RAM, magnetic A disc, an optical disc, etc., include several instructions to make a computer device (which may be a personal computer, a server, or a network device, etc.) execute each embodiment or some part of the method of the embodiment. Therefore, the present invention also provides a computer-readable storage medium storing a computer program that, when executed by a processor, realizes the steps of a preoperative planning method for high tibial osteotomy.

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Abstract

一种胫骨高位截骨的术前规划方法及其导板模型的构建方法。术前规划方法包括如下步骤：获取患者下肢的二维或三维影像，进行三维重建；选取患者下肢部位，拟合股骨头球心，并选取踝关节中心点以及通髁线（AB），以获取参考平面（P1）；在患者胫骨处选取合页点（Q），基于参考平面（P1），以合页点（Q）为起点，胫骨关节线与胫骨内侧轮廓线为终点，定义出第一截距线；基于垂直参考平面（P1）并通过第一截距引导线，获取第一截距引导面（P2）；基于合页点（Q）平行于第一截距引导面（P2）与参考平面（P1）相交形成的相交线方向的轴线，将第一截距引导面（P2）旋转一角度，获取第二截距引导面（P3）；完成截骨操作，并进行显示。

Description

胫骨高位截骨的术前规划方法及其导板模型的构建方法 技术领域
本发明涉及医疗器械领域，尤其涉及一种胫骨高位截骨的术前规划方法及其导板模型的构建方法。
背景技术
胫骨高位截骨术(high tibial osteotomy,HTO)目前已应用于治疗膝关节内侧间室骨关节炎(osteoarthritis,OA)，相较于传统全膝关节置换手术，HTO可有效保留膝关节股骨、胫骨以及髌骨等的关节面，因此特别适用于年轻的患者。HTO分为闭合楔形HTO和开放楔形HTO，由于闭合楔形HTO易产生房室综合征、侧肌分离、近端腓骨切断、肢体缩短以及腓神经伤害等并发症，因此开放楔形HTO更易获得有利的术后效果，且大量临床研究均证明了其疗效。传统的内侧开放楔形HTO中，医生凭借临床经验和现有的测量工具进行截骨手术操作，因而导致截骨精度和矫正精度对医生的经验依赖较高，此外，术中频繁的X射线透视测量，也增加了患者和医生的辐射危害。
因此，确有必要提供一种胫骨高位截骨的术前规划方法，以克服现有技术中存在的缺陷。
发明内容
本发明的目的在于提供一种胫骨高位截骨的术前规划方法及其导板模型的构建方法。
为实现上述目的，本发明提供了一种胫骨高位截骨的术前规划方法，包括如下步骤：获取患者下肢的二维或三维影像，进行三维重建；选取患者下肢部位，拟合股骨头球心，并选取踝关节中心点以及通髁线，以获取参考平面；在患者胫骨处选取合页点，基于参考平面，以合页点为起点，胫骨关节线与胫骨内侧轮廓线为终点，定义出第一截距线；基于垂直参考平面并通过第一截距引导线，获取第一截距引导面；基于合页点平行于第一截距引导面与参考平面相交形成的相交线方向的轴线，将第一截距引导面旋转一角度，获取第二截距引导面；完成截骨操作，并进行显示。
进一步地，基于参考平面，选取胫骨平台内外侧边缘点的连线为胫骨关节线。
进一步地，所述合页点为胫骨关节线及胫骨外侧边界线分别向内偏置一距离后形成的交点。
进一步地，所述胫骨关节线的偏置距离与胫骨关节线的长度成正相关。
进一步地，所述踝关节中心点为腓骨远端凸点与胫骨远端内侧凸点连线的中心点投影至 踝关节平面的投影点。
进一步地，所述通髁线为股骨侧内副韧带与外副韧带支点的连线。
进一步地，所述参考平面方向为下肢力线与通髁线的向量积求得的平面方向，所述下肢力线和通髁线均与参考平面平行。
为实现上述目的，本发明提供了一种胫骨高位截骨导板模型的构建方法，根据胫骨高位截骨的术前规划方法，构建胫骨高位截骨导板模型的外轮廓、截骨引导面及矫形角度，获取胫骨高位截骨导板模型。
为实现上述目的，本发明提供了一种电子设备，包括存储器、处理器及存储在存储器上并可在处理器上运行的计算机程序，所述处理器执行所述程序时实现胫骨高位截骨的术前规划方法的步骤。
为实现上述目的，本发明提供了一种计算机可读存储介质，存储有计算机程序，所述计算机程序被处理器执行时实现胫骨高位截骨的术前规划方法的步骤。
本发明通过工业软件获取胫骨参数及参数点，获取第一截距引导面和第二截距引导面，获得胫骨高位截骨术中的截骨面信息，根据具体手术操作对表面重建三维图像进行编辑得到操作模型，可有效剔除干扰信息，此时生成的手术计划是针对患者的下肢骨骼情况进行的设计，针对性强，设计出的手术计划精度高，亦无需医生在手术过程过多依赖手术经验来判断患者情况，从而增加手术完成度及术后效果，通过数字化手术结果生成手术方案，在一定程度降低了手术风险，缩减了手术时间，大大提升了手术效果。
附图说明
图1为本发明胫骨高位截骨的术前规划方法确定参考平面的示意图；
图2为本发明胫骨高位截骨的术前规划方法的确定两截骨面的示意图。
具体实施方式
为使本发明的上述目的、特征和优点能够更为明显易懂，下面结合附图对本发明的具体实施例作详细的说明。
请结合图1至图2所示，本发明的胫骨高位截骨的术前规划方法，用于在胫骨高位截骨术前进行模拟截骨和矫正操作，从而确认手术过程中需要截骨的准确位置及相关手术细节。为了便于描述，界定冠状面、矢状面和横断面。
所述胫骨高位截骨的术前规划方法包括如下若干步骤：
获取患者下肢的二维或三维影像，通过工业软件，进行三维重建；
选取患者下肢对应部位，拟合股骨头球心，并选取踝关节中心点以及通髁线AB，以获 取参考平面P1；
在患者胫骨处选取合页点Q，基于参考平面P1，以合页点Q为起点，胫骨关节线与胫骨内侧轮廓线为终点，定义出第一截距线；
基于垂直参考平面P1并通过第一截距引导线，获取第一截距引导面P2；
基于合页点Q平行于第一截距引导面P2与参考平面P1相交形成的相交线方向的轴线，将第一截距引导面P2旋转一角度，获取第二截距引导面P3；
完成截骨操作，并进行显示。
上述二维或三维影像可以是CT断层扫描影像或MRI扫描影像，或者其他可实现相同功能的影像，以通过工业软件实现重建。
在拟合股骨头球心过程中，在股骨头上任意选取四个不共面的点，根据空间任意不共面的四点可以确定一个球体，因此该球体的球心，即股骨头的中心点。当然，为了确保该球体与股骨头结构尽量一致，选取四点时，可以选取股骨头表面结构平滑处，且选点应该尽量均匀分布在股骨头表面各处。当拟合出的球体与股骨头结构相差较大时，可重新选点进行拟合，直至拟合出的球体与股骨头结构大体一致。
在本发明中，所述踝关节中心点为腓骨远端凸点与胫骨远端内侧凸点连线的中心点投影至踝关节平面的投影点。所述通髁线AB为股骨侧内副韧带与外副韧带支点的连线。
通过股骨头球心和踝关节中心获取下肢力线，下肢力线与通髁线AB的向量积求得的平面方向，即所述参考平面P1方向，所述下肢力线和通髁线AB均与参考平面P1平行。
基于参考平面P1方向，选取胫骨平台内外侧边缘点的连线为胫骨关节线。试试胫骨平台通常指以胫骨近端的干骺端及关节面拟合所得的平面。在冠状面视图上，从胫骨关节线内侧点开始获取胫骨内侧轮廓，从胫骨关节线外侧点开始获取胫骨外侧轮廓。
在本发明中，所述合页点Q为胫骨关节线及胫骨外侧边界线分别向内偏置一距离后形成的交点。所述胫骨关节线的偏置距离与胫骨关节线的长度成正相关，且胫骨关节线的偏置距离需要符合胫骨关节线偏置曲线经过腓骨近端上部。
在获取第二截距引导面P3时，两截骨位置之间形成的角度为钝角，可进行调节，使其能够分隔开胫骨结节与胫骨平台。
在完成第一截距引导面P2和第二截距引导面P3的获取后，即胫骨的截骨面已经确定，此时，在工业软件上显示相关截骨参数，并生成手术计划。根据具体手术操作对表面重建三维图像进行编辑得到操作模型，可有效剔除干扰信息，此时生成的手术计划是针对患者的下肢骨骼情况进行的设计，针对性强，设计出的手术计划精度高，亦无需医生在手术过程过多 依赖手术经验来判断患者情况，从而增加手术完成度及术后效果，通过数字化手术结果生成手术方案，在一定程度降低了手术风险，缩减了手术时间，大大提升了手术效果。
根据胫骨高位截骨的术前规划方法，构建胫骨高位截骨导板模型的外轮廓、截骨引导面及矫形角度，从而获取胫骨高位截骨导板模型。
引导截骨和矫正操作，以实现下肢力线的重建，恢复正常的膝关节运动。在本发明中，所述截骨手术引导工具100应用在胫骨高位截骨术中，且其是根据患者胫骨的医学图像数据重构的三维模型逆向设计并通过快速成型技术制成的。
上述胫骨高位截骨的术前规划方法的步骤可通过处理器执行程序时实现。因此，本发明提供一种电子设备，包括存储器、处理器及存储在存储器上并可在处理器上运行的计算机程序。所述处理器执行所述程序时实现胫骨高位截骨的术前规划方法的步骤。本发明的技术方案本质上或者说对现有技术做出贡献的部分或者该技术方案的部分可以以软件产品的形式体现出来，该计算机软件产品存储在一个存储介质中，包括若干指令用以使得一台计算机设备(可以是个人计算机，服务器，或者网络设备等)执行本发明各个实施例方法的全部或部分步骤。而前述的存储介质包括：U盘、移动硬盘、只读存储器(ROM，Read-Only Memory)、随机存取存储器(RAM，Random Access Memory)、磁碟或者光盘等各种可以存储程序代码的介质。
通过以上的实施方式的描述，本领域的技术人员可以清楚地了解到各实施方式可借助软件加必需的通用硬件平台的方式来实现，当然也可以通过硬件。基于这样的理解，上述技术方案本质上或者说对现有技术做出贡献的部分可以以软件产品的形式体现出来，该计算机软件产品可以存储在计算机可读存储介质中，如ROM/RAM、磁碟、光盘等，包括若干指令用以使得一台计算机设备(可以是个人计算机，服务器，或者网络设备等)执行各个实施例或者实施例的某些部分方法。因此，本发明还提供了一种计算机可读存储介质，存储有计算机程序，所述计算机程序被处理器执行时实现胫骨高位截骨的术前规划方法的步骤。
上文所列出的详细说明仅仅是针对本发明的可行性实施方式的具体说明，它们并非用以限制本发明的保护范围，凡未脱离本发明技艺精神所作的等效实施方式或变更均应包含在本发明的保护范围之内。

Claims (10)

  1. 一种胫骨高位截骨的术前规划方法，其特征在于：包括如下步骤：
    获取患者下肢的二维或三维影像，进行三维重建；
    选取患者下肢部位，拟合股骨头球心，并选取踝关节中心点以及通髁线，以获取参考平面；
    在患者胫骨处选取合页点，基于参考平面，以合页点为起点，胫骨关节线与胫骨内侧轮廓线为终点，定义出第一截距线；
    基于垂直参考平面并通过第一截距引导线，获取第一截距引导面；
    基于合页点平行于第一截距引导面与参考平面相交形成的相交线方向的轴线，将第一截距引导面旋转一角度，获取第二截距引导面；
    完成截骨操作，并进行显示。
  2. 如权利要求1所述的胫骨高位截骨的术前规划方法，其特征在于：基于参考平面，选取胫骨平台内外侧边缘点的连线为胫骨关节线。
  3. 如权利要求2所述的胫骨高位截骨的术前规划方法，其特征在于：所述合页点为胫骨关节线及胫骨外侧边界线分别向内偏置一距离后形成的交点。
  4. 如权利要求3所述的胫骨高位截骨的术前规划方法，其特征在于：所述胫骨关节线的偏置距离与胫骨关节线的长度成正相关。
  5. 如权利要求1所述的胫骨高位截骨的术前规划方法，其特征在于：所述踝关节中心点为腓骨远端凸点与胫骨远端内侧凸点连线的中心点投影至踝关节平面的投影点。
  6. 如权利要求1所述的胫骨高位截骨的术前规划方法，其特征在于：所述通髁线为股骨侧内副韧带与外副韧带支点的连线。
  7. 如权利要求1所述的胫骨高位截骨的术前规划方法，其特征在于：所述参考平面方向为下肢力线与通髁线的向量积求得的平面方向，所述下肢力线和通髁线均与参考平面平行。
  8. 一种胫骨高位截骨导板模型的构建方法，其特征在于：根据权利要求1所述的胫骨高位截骨的术前规划方法，构建胫骨高位截骨导板模型的外轮廓、截骨引导面及矫形角度，获取胫骨高位截骨导板模型。
  9. 一种电子设备，包括存储器、处理器及存储在存储器上并可在处理器上运行的计算机程序，其特征在于：所述处理器执行所述程序时实现如权利要求1至7任一项所述胫骨高位 截骨的术前规划方法的步骤。
  10. 一种计算机可读存储介质，存储有计算机程序，其特征在于：所述计算机程序被处理器执行时实现如权利要求1至7任一项所述胫骨高位截骨的术前规划方法的步骤。
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