CN113397767B - 一种方便置换的仿生型表面髋关节假体 - Google Patents
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Abstract
本发明涉及医疗器械设计技术领域,尤其涉及一种方便置换的仿生型表面髋关节假体,其包括髋臼杯假体、股骨头假体、压力主钉及张力辅钉,髋臼杯假体的内表面与股骨头假体的外表面为半球形滑动摩擦配合,髋臼杯假体及股骨头假体与骨接触面为3D打印骨小梁结构,股骨头假体内设有隔板使股骨头假体内形成头部凹槽及尾部凹槽,头部凹槽处装配有球面盖,压力主钉及张力辅钉后端部分别设有外螺纹,压力主钉与张力辅钉前端部分别与隔板连接。本发明提供的器械结构简单,置换方便,成本低,摩擦系数、金属离子析出较低,远期骨长入性能良好且能够重建髋关节生理支点。
Description
技术领域
本发明涉及医疗器械设计技术领域,尤其涉及一种方便置换的仿生型表面髋关节假体。
背景技术
表面髋关节假体是用于替代部分人体髋关节的骨科植入物。用来行表面髋关节置换手术。表面髋关节假体主要包括髋臼外杯假体,以及套入在髋臼外杯假体内且插入人体股骨头的股骨头假体。表面髋关节理论上可保留股骨骨质,减缓病情的进展,并能改善病人与今后翻修手术相关的髋关节功能。
但随着表面髋关节置换术的广泛开展,该手术也存在一些缺陷。导致假体失败的主要原因包括:股骨颈骨折、股骨头坍塌和假体松动等。现有的表面髋关节假体的髋臼外杯与股骨头假体的摩擦界面为钴铬钼金属的“金对金”界面,虽然“金对金”界面相对于其他摩擦界面摩擦系数相对较低,但“金对金”界面会导致钴、铬金属离子的析出,其会产生不利的生物学反应,包括关节附近软组织的毒性作用、延迟型超敏反应、骨质溶解以及一定的致癌性,最终导致假体松动失效。现有的表面髋关节假体的髋臼外杯的骨整合界面为喷涂的羟基磷灰石涂层,该方式会存在涂层脱落或在一定时间内被吸收的风险,导致失去相应的骨整合作用。现有的表面髋关节假体易发生股骨颈骨折、股骨头坍塌,其主要原因是由于股骨头假体的固定轴的设计方式无法重建生理支点,无法恢复正常人体髋关节受力形式,导致固定失败及并发症的产生。并且现有的股骨头置换假体为一体式结构,球面的顶部磨损后需要整体置换股骨头假体,成本比较高,而且手术操作比较麻烦,需要将压力主钉、张力辅钉及股骨头分离置换。
根据张殿英杠杆平衡重建理论,股骨近端是一种杠杆结构,其支点是由股骨的外展角及压力和张力骨小梁决定的,正常的生理支点位于股骨头中心附近,形成了一个股骨近端费力杠杆结构。以往的髋关节结构设计无理论支撑,本设计在于重建髋关节生理解剖支点并恢复压力及张力骨小梁,产生全仿生的人工髋关节假体。
发明内容
本发明所要解决的技术问题是提供摩擦系数、金属离子析出较低,远期骨长入性能良好且能够重建髋关节生理支点的一种方便置换的仿生型表面髋关节假体。
本发明是通过以下技术方案予以实现:
一种方便置换的仿生型表面髋关节假体,其包括髋臼杯假体、股骨头假体、压力主钉及张力辅钉,所述股骨头假体设于髋臼杯假体内且髋臼杯假体的内表面与股骨头假体的外表面为半球形滑动摩擦配合,髋臼杯假体及股骨头假体与骨接触面为3D打印骨小梁结构,所述股骨头假体内中部一体成型有隔板使股骨头假体内形成头部凹槽及尾部凹槽,所述头部凹槽处装配有与股骨头假体形成表面光滑球面的球面盖,所述压力主钉及张力辅钉后端部分别设有外螺纹,压力主钉与张力辅钉前端部分别与隔板连接。
优化的,髋臼杯假体、股骨头假体、压力主钉及张力辅钉均为锆铌合金材料,且髋臼杯假体内表面与股骨头假体外表面均经氧化处理形成氧化锆摩擦界面。
进一步,球面盖与头部凹槽之间为相互配合的锥形连接。
优化的,隔板上开设有两个螺纹孔,压力主钉与张力辅钉前端部分别在螺纹孔处与隔板螺纹连接。
进一步,压力主钉的前端与螺纹孔之间为螺纹连接,张力辅钉倾斜设置且整体设有外螺纹。
优化的,压力主钉上开设有斜插孔,张力辅钉穿过斜插孔后与隔板在螺纹孔处通过螺纹连接。
进一步,张力辅钉的外螺纹延伸至与压力主钉斜插孔斜插位置处。
优化的,压力主钉和张力辅钉为全螺纹结构。
本发明的有益效果
本发明保护的一种方便置换的仿生型表面髋关节假体,具有如下优势:
1.①锆铌合金氧化层高温后与表面髋关节假体形成一体,不存在涂层脱落问题。②锆铌合金表面摩擦系数是钴铬合金界面的0.5倍,具有优秀的耐磨性能。③锆铌合金的强度、耐腐蚀性及润滑度均优于钴铬合金,可以减少关节置换术后假体破碎及骨溶解的发生。④锆铌合金具有理想的生物相容性及低敏性的优势。
2. 3D打印骨小梁结构具有以下优势:①3D打印骨小梁结构应力分布更为优化,最大应力值明显减小,因此会降低应力遮挡效应,利于假体周围骨质增长,避免假体松动的风险。②模仿人体松质骨结构的骨小梁多孔结构,具有良好的生物相容性。③3D打印骨小梁髋臼外杯具有高摩擦系数、高孔隙率和更好的力学性能。④3D打印技术颗粒残留低、金属离子析出量低,避免出现人体异物排斥、过敏、严重炎症的不良反应。
3.股骨头假体的固定形式可将髋关节支点恢复到股骨近端张力骨小梁与压力骨小梁交汇点处,恢复到人体正常髋关节支点,避免由于人体髋关节力学不平衡,导致假体松动的产生。
4.股骨头假体内中部一体成型有隔板使股骨头假体内形成头部凹槽及尾部凹槽,所述头部凹槽处装配有与股骨头假体形成表面光滑球面的球面盖,头部凹槽方便球面盖的装配,并且当球面盖处由于受力较大磨损较严重时,可以单独更换球面盖,更换时,无需更换股骨头假体手术操作更简单,手术成本也比较低,并且股骨头假体的整体稳固性也比较强。
附图说明
图1为本发明具体实施例一爆炸结构示意图;
图2为本发明具体实施例一装配示意图;
图3为本发明具体实施例二爆炸结构示意图;
图4为本发明具体实施例二装配示意图;
图5为本发明对照组仿真应力分布图;
图6为本发明具体实施例一仿真应力分布图;
图7为本发明具体实施例二仿真应力分布图。
图中1.股骨头假体,2.尾部凹槽,3.压力主钉,4.张力辅钉,5.隔板,6.球面盖,7.头部凹槽,8.斜插孔。
具体实施方式
一种方便置换的仿生型表面髋关节假体,其包括髋臼杯假体(未示出)、股骨头假体1、压力主钉3及张力辅钉4,所述股骨头假体设于髋臼杯假体内且髋臼杯假体的内表面与股骨头假体的外表面为半球形滑动摩擦配合,髋臼杯假体及股骨头假体与骨接触面为3D打印骨小梁结构,应力分布更为优化,最大应力值明显减小,降低了应力遮挡效应,利于假体周围骨质增长,避免假体松动的风险,并且具有良好的生物相容性及力学性能。
股骨头假体内中部一体成型有隔板5使股骨头假体内形成头部凹槽7及尾部凹槽2,所述头部凹槽处装配有与股骨头假体形成表面光滑球面的球面盖6,将股骨头假体分为两部分,设置一个球面盖,当球面盖处由于受力较大磨损较严重时,可以单独更换球面盖,更换时,无需更换股骨头假体手术,操作更简单,手术成本也比较低。
压力主钉及张力辅钉后端部分别设有外螺纹,压力主钉与张力辅钉前端部分别与隔板连接。压力主钉与张力辅钉的设计,可以起到固定防旋的作用。
优化的,髋臼杯假体、股骨头假体、压力主钉及张力辅钉均为锆铌合金材料,其弹性模量低于传统的钴铬钼合金材料,可以降低应力遮挡,髋臼杯假体内表面与股骨头假体外表面均经氧化处理形成氧化锆,二者之间形成良好的摩擦界面。
进一步,球面盖与头部凹槽之间为相互配合的锥形连接,股骨头假体的整体稳固性比较强。
具体实施例一,隔板上开设有两个螺纹孔,压力主钉与张力辅钉前端部分别在螺纹孔处与隔板螺纹连接。
压力主钉的前端与螺纹孔之间为螺纹连接,张力辅钉倾斜设置且整体设有外螺纹。
压力主钉、张力辅钉与隔板之间采用螺纹连接,方便手术操作,压力主钉的前端与螺纹孔之间为螺纹连接,使压力主钉的固定更加稳固,而张力辅钉倾斜设置且整体设有外螺纹,可以根据患者实际需要调整张力辅钉角度,整体设有外螺纹更加便于骨生长。
具体实施例二,压力主钉上开设有斜插孔8,张力辅钉穿过斜插孔后与隔板在螺纹孔处通过螺纹连接,压力主钉与张力辅钉交叉设置,结构更加稳固,更加有利于骨生长,并且防旋作用更强。
张力辅钉的外螺纹延伸至与压力主钉斜插孔斜插位置处,便于骨生长。
优化的,压力主钉中部光滑部位为骨小梁结构,进一步提高生物相容性,促进骨生长。
手术时,操作在股骨头处进行,先插入股骨头假体,再插入压力主钉,然后插入张力辅钉,最后安装球面盖,最后将股骨头假体与髋臼杯假体球面配合安装。
本发明是一种方便置换的仿生型表面髋关节假体,股骨头假体内中部一体成型有隔板使股骨头假体内形成头部凹槽及尾部凹槽,头部凹槽处装配有与股骨头假体形成表面光滑球面的球面盖,头部凹槽方便球面盖的装配,并且当球面盖处由于受力较大磨损较严重时,可以单独更换球面盖,更换时,无需更换股骨头假体,手术操作更简单,手术成本也比较低。
同时设置压力主钉及张力辅钉两个螺钉,可以形成仿生压力骨小梁和张力骨小梁,尽量还原原生骨受力情况,股骨头假体的固定轴采用将重建的支点恢复到股骨近端压力骨小梁与张力骨小梁交汇点处的形式,形成生理杠杆受力结构,模拟原生骨受力设计结构,能够有效防止假体松动,改善了股骨颈受力,降低了股骨颈骨折发生的概率。
同时由于髋臼杯假体、股骨头假体、压力主钉及张力辅钉均为锆铌合金材料,其弹性模量低于传统的钴铬钼合金材料,可以降低应力遮挡,髋臼杯假体内表面与股骨头假体外表面均经氧化处理形成氧化锆。二者之间形成良好的摩擦界面,不会出现涂层脱落,且耐磨性、耐腐蚀性及润滑度比较强,从而减少关节置换术后假体破碎及骨溶解的发生,并且锆铌合金具有理想的生物相容性及低敏性的优势,颗粒残留低、金属离子析出量低,避免出现人体异物排斥、过敏、严重炎症的不良反应。
本发明具体实施例和对照组的有限元模型进行有限元分析如下:
对照组为传统髋关节表面置换假体。
实验验证
本发明实施例一和对照组的有限元模型进行有限元分析,如图5-6所示,对照组应力集中范围为0.01~5.18MPa,实施例一应力集中范围为0.01~5.09MPa,实施例一应力集中范围较小,实施例一假体对人体股骨的应力损伤小。
对本发明实施例二和对照组的有限元模型进行有限元分析,如图5、7所示,对照组应力集中范围为0.01~5.18MPa,实施例二应力集中范围为0.01~4.22MPa,因此,实施例二应力集中范围较小,实施例二假体对人体股骨的应力集中损伤小。
注:本申请附图中未示出髋臼杯假体,其为现有技术,外形结构与股骨头假体相似,且内表面与股骨头假体的外表面相配合。
综上所述,本发明是一种方便置换的仿生型表面髋关节假体,结构简单,置换方便,成本低,摩擦系数、金属离子析出较低,远期骨长入性能良好且能够重建髋关节生理支点。
以上所述仅为本发明的优选实施例而已,并不用于限制本发明,对于本领域的技术人员来说,本发明可以有各种更改和变化。凡在本发明的精神和原则之内,所作的任何修改、等同替换、改进等,均应包含在本发明的保护范围之内。
Claims (8)
1.一种方便置换的仿生型表面髋关节假体,其特征在于,包括髋臼杯假体、股骨头假体、压力主钉及张力辅钉,所述股骨头假体设于髋臼杯假体内且髋臼杯假体的内表面与股骨头假体的外表面为半球形滑动摩擦配合,髋臼杯假体及股骨头假体为3D打印骨小梁结构,所述股骨头假体内中部一体成型有隔板使股骨头假体内形成头部凹槽及尾部凹槽,所述头部凹槽处装配有与股骨头假体形成表面光滑球面的球面盖,所述压力主钉及张力辅钉后端部分别设有外螺纹,压力主钉与张力辅钉前端部分别与隔板连接,将髋关节支点恢复到股骨近端张力骨小梁与压力骨小梁交汇点处。
2.根据权利要求1所述的一种方便置换的仿生型表面髋关节假体,其特征在于,髋臼杯假体、股骨头假体、压力主钉及张力辅钉均为锆铌合金材料,且髋臼杯假体内表面与股骨头假体外表面均经氧化处理形成氧化锆摩擦界面。
3.根据权利要求1所述的一种方便置换的仿生型表面髋关节假体,其特征在于,球面盖与头部凹槽之间为相互配合的锥形连接。
4.根据权利要求1所述的一种方便置换的仿生型表面髋关节假体,其特征在于,所述隔板上开设有两个螺纹孔,压力主钉与张力辅钉前端部分别在螺纹孔处与隔板螺纹连接。
5.根据权利要求4所述的一种方便置换的仿生型表面髋关节假体,其特征在于,压力主钉的前端与螺纹孔之间为螺纹连接,张力辅钉倾斜设置且与压力主钉同为全螺纹结构。
6.根据权利要求4所述的一种方便置换的仿生型表面髋关节假体,其特征在于,所述压力主钉上开设有斜插孔,张力辅钉穿过斜插孔后与隔板在螺纹孔处通过螺纹连接。
7.根据权利要求6所述的一种方便置换的仿生型表面髋关节假体,其特征在于,张力辅钉的外螺纹延伸至与压力主钉斜插孔斜插位置处。
8.根据权利要求1所述的一种方便置换的仿生型表面髋关节假体,其特征在于,压力主钉中部光滑部位为骨小梁结构。
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