CN101766508B - 股骨头置换模块及手术工具 - Google Patents

股骨头置换模块及手术工具 Download PDF

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CN101766508B
CN101766508B CN2008102082496A CN200810208249A CN101766508B CN 101766508 B CN101766508 B CN 101766508B CN 2008102082496 A CN2008102082496 A CN 2008102082496A CN 200810208249 A CN200810208249 A CN 200810208249A CN 101766508 B CN101766508 B CN 101766508B
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femur
femoral head
neck
cover body
replacement module
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CN101766508A (zh
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施鲁孙
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  • Oral & Maxillofacial Surgery (AREA)
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Abstract

本发明公开了一种股骨头置换模块及手术工具，其手术工具包括一裁切模套与一模刀，该裁切模套一中空且具有与股骨颈表面相同形状的壳体，使其可简易、紧密套合于股骨颈周侧，以供一模刀将股骨头欲置换端形切成一预设解剖断面的形状，且便于手术完毕后取下，于该裁切模套顶侧设有一导管，以供对股骨头钻设一中央孔，裁切模套中段横设一横槽道，可供作切除股骨头的精确导引；而该股骨头置换模块则至少包括一罩体与一人工股骨头，该罩体利用立体扫描仪器辅助，使其基端的形状成型为具有与股骨颈下方大小粗细相同的表面形状，且其顶段设与上述股骨头置换端相同或近似的解剖断面，使该人工股骨头的罩体亦能以精密而稳固的状态结合于上述股骨头置换端。

Description

股骨头置换模块及手术工具
技术领域
本发明涉及一种股骨头置换模块及其手术工具，特别是涉及一种以置换股骨颈表面的结构，有效改善人工股骨头与原始股骨头间的结合精确度，进而得以提升手术后的股骨纠正质量者。
背景技术
传统关于有柄或无柄人工髋关节的股骨头置换手术，其常见的切除部位为如图1所示，主要是直接将股骨4沿股骨颈41的基底部斜向(如切除线L4所示)切除该颈部连同病变或磨损的股骨头42，并将股骨髓腔掏空扩大后植入固定一人工髋关节柄，并由该人工髋关节柄结合一人工股骨头5；此种手术切除方式，于美国专利第5163961号“COMPRESSION-FIT HIP PROSTHSIS AND PROCEDURES FOR IMPLANTATION THEREOF”专利案中，以及中国实用新型专利公告第CN2430959Y号【自锁式无柄人工髋关节】专利案中，自头颈部切除病变或磨损的股骨头42，并将一罩体51以螺栓固定于残留的股骨颈上，皆有明确的相关揭示，显见均已确为极普遍的手术方式；然而，此以上各种手术方式于实际应用上却有下列缺点：
1)由于有柄人工髋关节置换手术需进行大部位的骨头与骨髓切除、掏除及塑型，使得手术的创伤程度、作业时间及失血量皆为的大幅增加，大大升高了整体手术的危险性；
2)由于大部位的骨头(如股骨颈的全部)的切除或掏除，均造成相关尺寸精度不易控制的因素，致使有柄人工髋关节柄表面或无柄人工髋关节的罩体内表面与装设的骨头表面准确匹配精度难以保持，不仅该等人工髋关节无法由较坚硬的骨头或骨颈表面来达到稳固的结合支撑力，容易因而造成应力集中的现象，直接而严重地影响手术的结果与手术愈后质量；
3)由于各种人工关节皆有其使用年限，经过长久使用后，往往都会有磨损、松动及下沉等合并症发生的情形而必须进行翻修手术，而上述传统有柄人工髋关节置换手术其由于初次手术切除部位及创伤极大，致使在需再次翻修手术时，则一般均需将整个股骨随腔再次扩大加深，如此一来，必然增加了创伤及手术的困难度；
4)传统无柄人工髋关节股骨头置换手术的骨头切除部位由于并无较科学且完整明确的量测定位方式及程序，因此大多需依靠手术者的经验来决定股骨颈部切除位置，而不同手术操作者所得到手术后结果亦有明显差异，难以确保手术的一致性，因此，手术的成败与良劣无法在手术前进行预先的模拟推演及评估，病患术前的心理建设较为困难；
5)如图1所示，由于无柄人工髋关的罩体51斜设于该平行切除线L4的裁切平面上，且其股骨颈41表面无法保证与罩体51内部表面形成连续性紧配合，而使得关节应力无法均匀分布与传导，致使实际应用上容易产生应力集中，而影响其整体结构的耐用性，实有加以改进的必要。
鉴于常见髋关节的股骨头置换手术有上述缺点，因此，需开发针对上述缺点的研究改进发明。
发明内容
本发明的主要目的在于提供一种股骨头置换模块，其可有效确保各部位间的组装精度，以改善手术后的髋关节的纠正效果，并提升手术质量。
本发明的另一目的在于提供一种股骨头置换模块，其直接组合固定于股骨颈上，而可以最大化面积保留该股骨颈部位，且不破坏股骨髓腔，因此，当有该部位需再次手术更新时，可再实施如传统有柄人工髋关节完全切除股骨颈部位的手术，以延长股骨的使用寿命。
本发明的再一目的在于提供一种股骨头置换模块，其可紧密地套合于股骨颈上，且使其可完善地服贴于股骨颈近端表面上，并扩展延伸至股骨颈远程基底部，使不仅以置换模块取代(置换)已去除的股骨颈近端部位，并延伸至股骨颈的远程基底部位，使得以与近端去除股骨颈表面的部位及远程之未去除表面坚实部位取得最大解剖形支撑面积，以大幅增进其结合于股骨头上之后的强度，以确实牢固地将人工关节结合于人体股骨颈上，进而大幅确保及延长其使用寿命的目的。
本发明的又一目的在于提供一种股骨头置换手术工具，其通过由计算机扫描数据所精确组制，不仅可符合生物力学机理，亦可减少骨骼裁切面积而可降低手术的损伤及困难度，更可配合适当的仿真软件，将上述工具数据输入，以进行术前的推演模拟，使手术操作者可先行熟习手术过程中的各种状况，以提升手术成功率，并建立患者术前的信心，减少手术的危险性。
为达成上述目的及功效，本发明所实行的技术手段包括：提供一种股骨头置换模块，其至少包括：一罩体及一人工股骨头，该罩体具有二相对延伸的一凹部与一向外凸伸的结合部，该凹部具有一基段及一顶段，该基段的内表面形状及尺寸以医疗用立体扫描仪器扫描患者股骨颈表面所获得，该顶段的内表面形状及尺寸，则以股骨颈表面周缘距中心线最短距离的各点所连接成的一切除封闭曲线为基准而向内成型，使该顶段可紧密套合于股骨的股骨颈上所对应形切出的凸部，且以该罩体的内表面与股骨颈表面形成紧密结合与定位，以提升其结合强度；而该人工股骨头具有一凹孔，可供套合于该罩体的结合部上并加以固定。
本发明另提供一种股骨头置换手术工具，其至少包括：一裁切模套及一模刀，该裁切模套是一具有股骨颈表面形状的中空壳体，其并于中间部位剖切成一侧开口，于该裁切模套顶侧设有一沿股骨颈中心线延伸的导管，以供于股骨头上对应位置开设一中央孔，另于裁切模套中段横设一可供导引裁切位置的横槽道，该模刀设有一套管部及一裁切形刀部，于该裁切形刀部末端为一开口，于该开口的周缘设有锋利的刃部，且该刃部位置的尺寸及断面形状相符合于股骨颈表面周缘距中心线最短距离的各点所连接成的一切除封闭曲线，而该套管部套合于一设置在中央孔上的导引件以形成往复滑移的动作，利用该往复滑移的操作使该裁切开口上的刃部得以简易朝股骨颈欲置换部位进行形切操作。
由于采用上述结构，本发明可达到提升手术质量、延长使用寿命并降低手术危险性的功效。
附图说明
下面结合附图与具体实施方式对本发明作进一步详细的说明：
图1是常见髋关节置换手术中常见的股骨头切除部位及人工股骨头装设结构示意图；
图2是本发明的股骨头初次裁切部位及其相关定位线条示意图；
图3是本发明的股骨颈周缘切削所需的切除封闭曲线及另一置换封闭曲线位置示意图；
图4是本发明的裁切模套立体结构图；
图5是本发明于股骨头初次裁切后的裁切部位俯视图；
图6是本发明于股骨头初次裁切后的立体外观图；
图7是本发明的裁切模套结合于初次裁切后股骨端部的状态示意图；
图8是本发明的模刀立体结构图；
图9是本发明的模刀侧视剖面图；
图10是本发明的模刀操作动作示意图；
图11是本发明经模刀切削后的股骨颈形成锥凸部的状态示意图；
图12是本发明的人工股骨头组件立体结构图；
图13是本发明的人工股骨头组装完成后立体外观图；
图14是本发明的人工股骨头组合后侧视剖面图；
图15是本发明的人工股骨头组装完成后另一侧立体外观图；
图16是本发明的实际应用示意图；
图17是本发明的人工股骨头组件另一较佳实施例图。
其中，附图标记如下：
1-裁切模套         314-贯孔
10-底段部位        315-定位凹部
11-侧开口          316-辅助定位组件
12-顶平面          32-定位组件
13-导管            33、5-人工股骨头
131、211-导引孔    331-凹孔
132-钻孔设备       341-延伸固定部
14、312-下侧缘     342-定位件
15-定位孔          35-套座
151-暂时定位组件   4、40、400-股骨
16-横槽道          41-股骨颈
161-纵槽道         42-股骨头
2-模刀             43-中央孔
21-套管部          44-凸部
22-裁切形刀部      51-座体
221-刃部           C1-切除封闭曲线
23-导引件          C2-置换封闭曲线
3-人工股骨头组件   CL-中心线
31、34-罩体        L2-颈头界面线
311-凹部           L3-初次裁切线
3111-基段          L4-切除线
3112-顶段     P2-裁切面
313-结合部    P3-初次裁切面
具体实施方式
为使本发明的上述目的、功效及特征可获致更具体的了解，兹依下列附图说明如下：
参图2、图3所示，首先，于手术前需于股骨4的股骨头42与股骨颈41的弧线衔接部位取出一侧视适当的颈头接口线L2，并于该颈头界面线L2旁侧向股骨头42方向适当距离取一与该颈头接口线L2平行的初次裁切线L3，利用该颈头接口线L2或初次裁切线L3为基准，定出一股骨头42及股骨颈41的共同中心线CL，同时，利用医疗用立体(三维)扫描仪器(如：断层扫描CT或核磁共振MRI)测知该股骨颈41表面形状数据(数据)，再由该中心线CL向股骨颈41周缘分别取出最短距离，以形成一最窄断面的切除封闭曲线C1，另于该切除封闭曲线C1以下的股骨颈41基部与股骨4间取出最大衔接断面，并以该断面的周缘线形成一置换封闭曲线C2。
参图4至图11所示，可知本发明的手术工具主要包括：一裁切模套1及一模刀2，该裁切模套1利用股骨颈41周缘的表面形状配合该初次裁切线L3的位置而形成其基本形状，其至少在对应上述切除封闭曲线C1以下的底段部位10具有符合或接近股骨颈41外表面形状与尺寸的内表面，且于对应初次裁切线L3的部位设有一不小于上述初次裁切线L3所形成的股骨颈断面的顶平面12，并于中间部位可纵向剖切成一侧开口11，而于该顶平面12上设有一导管13，该导管13内设一沿中心线CL延伸的导引孔131，且该裁切模套1中段于顶平面12旁侧对应该颈头接口线L2位置设一横槽道16，并于该横槽道16中段设有一平行于中心线CL的纵槽道161；于裁切模套1表面更可布设复数定位孔15，且使裁切模套1底段部位10的边缘形成符合该置换封闭曲线C2形状的下侧缘14(如图4所示)；该模刀2以一套管部21结合一裁切形刀部22所构成，其中该裁切形刀部22可设成具口大内小开口的内锥形式，于该裁切形刀部22周缘设有符合该切除封闭曲线C1形状与尺寸且锋利的刃部221(如图8、图9所示)。
使用时，先沿该初次裁切线L3裁切股骨头42，使股骨40于该裁切部位形成一初次裁切面P3(如图5、图6所示)，将该裁切模套1以侧开口11套合于股骨颈41外表，利用复数暂时定位组件151分别贯穿各定位孔15并嵌入股骨40内，可使该裁切模套1稳固地结合于股骨颈41周缘部位(如图7所示)，此时，利用横槽道16的导引，可供手术者确认该颈头接口线L2的正确位置，同时可通过由纵槽道161刻划中心线CL的位置，且利用钻孔设备132由导管13的导引孔131伸入，可于该初次裁切面P3上对应中心线CL的位置钻设一中央孔43，再利用该横槽道16切除颈头接口线L2以上的股骨头。
接着，再以一导引件23(可为一条柱体)插置或锁接于该中央孔43，使该模刀2的套管部21套合于该导引件23上往外延伸出的部份，而可实施往复滑移的动作(如图10所示)，通过由该裁切形刀部22上的刃部221得以切削该切除封闭曲线C1上方的股骨头42边缘，以形成一具有中央孔43的下大上小锥状的凸部44，且该凸部44外部形状接近该股骨颈最窄断面形状(如图11所示)。
再请参图12至图15，可知本发明的置换模块(即人工股骨头组件3)包括：一罩体31及一人工股骨头33；该罩体31具有二相对延伸的凹部311与一向外凸伸的结合部313，该凹部311与结合部313之间以一贯孔314相通，利用上述取得的股骨颈41表面形状资料，撷取该切除封闭曲线C1与置换封闭曲线C2间的表面形状资料，可作为该凹部311一基段3111的内表面形状数据，而该凹部311内的基段3111上方则为一顶段3112，该顶段3112的表面形状及尺寸即符合上述模刀2所形切而成，且位于切除封闭曲线C1渐缩至颈头接口线L2之间接近股骨颈最窄断面的形状，而该罩体31底侧边缘则形成符合该置换封闭曲线C2形状的下侧缘312，同时于该凹部311边缘可依需要至少设有一定位凹孔315(如图12所示)。
组装时，以该罩体31套合于股骨400具凸部44的置换端，此时，该凸部44恰可套入罩体31的顶端3112，且罩体31的基段3111可吻合地套合于切除封闭曲线C1至置换封闭曲线C2间的股骨颈表面(如图13及图14所示)，令该罩体31与股骨颈之间形成高贴合度的稳固结合，而后，再以一定位组件32(螺钉)贯穿罩体31的贯孔314后伸(螺)入凸部44的中央孔43内，配合一辅助定位组件316贯穿定位凹孔315后伸(螺)入凸部44旁侧的股骨400内，可使该罩体31于股骨400端部形成稳固的定位，然后，再以一人工股骨头33以其预设的凹孔331套合于该罩体31的结合部313上并加以固定(如图15所示)，则可完成此股骨头置换手术；而于实际应用时，于该人工股骨头33外周侧可套合一套座35，该套座35可包覆于人工股骨头33外并形成相对枢转的结合，使该人工股骨头组件3与套座35分别装设于人体髋关结的二相对活动部位，即可取代患者损坏的髋关结组织。
本发明利用上述裁切模套1、模刀2等手术工具加以辅助，可有效确保需裁切、钻孔或切削等各部位的位置准确性，以提升组装的精度，进而改善手术后的髋关节的纠正效果，并提升手术质量，更适于配合计算机仿真软件，提供手术前的推演操作，令手术操作者可于术前进行模拟，达到降低手术误差、熟悉手术过程，进而确保手术成功率的优良设计；再者，由于罩体31紧密套合于股骨颈41顶端对应设置的凸部44上，并配合定位组件32、辅助定位组件316的固定，因此具有较佳的结合强度，以形成更稳固的结合状态，而该罩体31可与股骨400的相衔接端部之间形成最大的有效接触及置换面积，以分散该人工股骨头组件3传递至股骨颈41上的作用力，如此，不但可降低股骨400端部的各部压力、避免应力集中所造成的破坏，亦可大幅增强该置换部位的作用力承受度，进而达到延长整体组件使用寿命的目的；同时相较于传统直接由股骨颈41的基部切除股骨头42的手术方式，本发明由于由股骨颈41上方的切除封闭曲线C1切除股骨头42，而可保留该股骨颈41的切除封闭曲线C1以下大部份结构，故而，若有罩体31或人工股骨头组件3的其它组件损坏而需再度手术时，则可再进行一次上述的传统手术(沿切除线L4切除股骨颈41)，因此可有效延长股骨400的使用寿命。
图17是本发明的人工股骨头组件另一较佳实施例图，由该图所示，可知本发明的另一人工股骨头组件30除了相同的人工股骨头33外，可具有另一种罩体34结构，该罩体34以罩体31的结构为基础，仅于其底侧边缘增设一片状的延伸固定部341，该延伸固定部341可供复数定位件342(螺栓)贯穿而嵌(螺)入股骨400内，此种加强定位的结构，尤其适用于具有骨质疏松情形的患者，可使该罩体34可产生更佳的定位效果。
综合以上所述，本发明的股骨头置换模块及其手术工具确可达到提升手术质量、延长使用寿命并降低手术危险性的功效，但上述说明内容，仅为本发明的较佳实施例说明，举凡依本发明的技术手段与范畴所延伸的变化、修饰、改变或等效置换者，亦皆应落入本发明的专利申请范围内。

Claims (13)

1.一种股骨头置换模块，其特征在于：其至少包括：
一罩体，具有二相对延伸的一凹部与一向外凸伸的结合部，该凹部具有一基段及一顶段，该基段的内表面形状及尺寸以医疗用立体扫描仪器扫描患者股骨颈表面所获得，该顶段的内表面形状及尺寸，则以股骨颈表面周缘距中心线最短距离的各点所连接成的一切除封闭曲线为基准而向内成型，使该顶段可紧密套合于股骨的股骨颈上所对应形切出的凸部，且以该罩体的内表面与股骨颈表面形成紧密结合与定位；
一人工股骨头，套合固定于该罩体的结合部上，该罩体的凹部与该结合部之间以一贯孔相通。
2.如权利要求1所述的股骨头置换模块，其特征在于：该贯孔设于所述罩体中央，可供一定位组件贯穿并伸入股骨颈的凸部顶面而形成定位。
3.如权利要求1或2所述的股骨头置换模块，其特征在于：所述罩体上至少另设有一定位凹孔，可供一辅助定位组件贯穿并伸入股骨上的对应部位。
4.如权利要求1或2所述的股骨头置换模块，其特征在于：所述罩体另设有至少一片状的延伸固定部，该延伸固定部可供至少一定位件贯穿嵌入股骨内。
5.如权利要求3所述的股骨头置换模块，其特征在于：所述罩体另设有至少一片状的延伸固定部，该延伸固定部可供至少一定位件贯穿嵌入股骨内。
6.如权利要求1或2所述的股骨头置换模块，其特征在于：所述股骨颈上的凸部呈一上小下大的锥状凸起。
7.如权利要求3所述的股骨头置换模块，其特征在于：所述股骨颈上的凸部呈一上小下大的锥状凸起。
8.如权利要求4所述的股骨头置换模块，其特征在于：所述股骨颈上的凸部呈一上小下大的锥状凸起。
9.如权利要求5所述的股骨头置换模块，其特征在于：所述股骨颈上的凸部呈一上小下大的锥状凸起。
10.如权利要求1或2所述的股骨头置换模块，其特征在于：所述股骨颈基部与股骨间可取出最大衔接部位，以形成一置换封闭曲线，而该罩体底侧边缘则具有符合该置换封闭曲线的形状。
11.如权利要求3所述的股骨头置换模块，其特征在于：所述股骨颈基部与股骨间可取出最大衔接部位，以形成一置换封闭曲线，而该罩体底侧边缘则具有符合该置换封闭曲线的形状。
12.如权利要求4所述的股骨头置换模块，其特征在于：所述股骨颈基部与股骨间可取出最大衔接部位，以形成一置换封闭曲线，而该罩体底侧边缘则具有符合该置换封闭曲线的形状。
13.如权利要求6所述的股骨头置换模块，其特征在于：所述股骨颈基部与股骨间可取出最大衔接部位，以形成一置换封闭曲线，而该罩体底侧边缘则具有符合该置换封闭曲线的形状。
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