CN113456305A - 一种方便手术操作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,尤其涉及一种方便手术操作的仿生型表面髋关节假体,其包括髋臼杯假体、股骨头假体、假体中间体、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,所述假体中间体设于股骨头假体内且假体中间体外表面与股骨头假体内表面通过锥面配合,髋臼杯假体、股骨头假体及假体中间体与骨的接触面均为3D打印骨小梁结构,所述压力主钉与张力辅钉后端部均与假体中间体连接。本发明提供的器械摩擦系数、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,尤其涉及一种方便手术操作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***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。
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手术操作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:
一种方便手术操作的仿生型表面髋关节假体,其包括髋臼杯假体、股骨头假体、假体中间体、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,所述假体中间体设于股骨头假体内且假体中间体外表面与股骨头假体内表面通过锥面配合,髋臼杯假体、股骨头假体及假体中间体与骨的接触面均为3D打印骨小梁结构,所述压力主钉与张力辅钉后端部均与假体中间体连接。
优化的,髋臼杯假体、股骨头假体、假体中间体、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。
优化的,假体中间体为碗状结构,碗状结构的下部与股骨头假体的内表面形成锥面配合且在碗状结构的侧面开设两个螺纹孔,压力主钉与张力辅钉后端部均在螺纹孔处与假体中间体通过螺纹连接,压力主钉与张力辅钉前端部均设有外螺纹。
优化的,假体中间体为锥台形与股骨头假体内表面配合,锥台底面开设有张力辅钉螺纹通孔,压力主钉与假体中间体一体成型且为全螺纹结构,所述张力辅钉为全螺纹结构且后端部安装在张力辅钉螺纹孔内。
进一步,压力主钉在靠近股骨颈的位置开设有斜插孔,张力辅钉穿过斜插孔与压力主钉交叉设置。
本发明的有益效果
本发明保护的一种方便手术操作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打印骨小梁结构具有高摩擦系数、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(股骨头中心附近),避免由于人体髋关节受力不平衡,导致假体松动的产生。
4.设置一个假体中间体,手术时,可以先将压力主钉、张力辅钉与假体中间体连接好并植入皮质骨后,再将假体中间体与股骨头假体通过锥面配合连接,然后再将股骨头假体与髋臼杯假体装配,完成手术,手术更易操作。
附图说明
图1为本发明具体实施例一***结构示意图;
图2为本发明具体实施例一装配结构示意图;
图3为本发明具体实施例二***结构示意图;
图4为本发明具体实施例二装配结构示意图;
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有限元分析应力分布图;
图7为本发明具体实施例二有限元分析应力分布图;
图中01.股骨头假体,02.螺纹孔,03.假体中间体,04.张力辅钉,05.斜插孔,06.压力主钉。
具体实施方式
一种方便手术操作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、假体中间体3、压力主钉6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,所述假体中间体设于股骨头假体内且假体中间体外表面与股骨头假体内表面通过锥面配合。设置一个假体中假体,手术时可以先将压力主钉、张力辅钉与假体中间体连接好并植入皮质骨后,再将假体中间体于股骨头假体通过锥面配合连接,然后再将股骨头假体装入髋臼杯假体内,手术的操作更加方便快捷。
髋臼杯假体、股骨头假体及假体中间体与骨的接触面均为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,且颗粒残留低、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。
髋臼杯假体、股骨头假体、假体中间体、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,不会造成涂层脱落,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。
压力主钉与张力辅钉后端部均与假体中间体连接,压力主钉与张力辅钉的设计,可以起到固定防旋的作用。
具体实施例一,假体中间体为碗状结构,碗状结构的下部与股骨头假体的内表面形成锥面配合且在碗状结构的侧面开设两个螺纹孔2,压力主钉与张力辅钉后端部均在螺纹孔处与假体中间体通过螺纹连接,压力主钉与张力辅钉前端部均设有外螺纹。
采用假体中间体为碗状结构,碗状结构的下部与股骨头假体的内表面形成锥面配合且在碗状结构的侧面开设两个螺纹孔,压力主钉和张力辅钉在股骨颈处交叉,此结构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。
具体实施例二,假体中间体为锥台形与股骨头假体内表面配合,锥台底面开设有张力辅钉螺纹通孔,压力主钉与假体中间体一体成型,张力辅钉与压力主钉为全螺纹结构且张力辅钉后端部安装在假体中间体张力辅钉螺纹孔内。
此结构压力主钉与假体中间体一体,压力主钉与假体中间体同时安装,张力辅钉与压力主钉为全螺纹结构,结构及安装都相对简单,压力主钉结构强度高,***稳定性高。
进一步,压力主钉在靠近股骨颈的位置开设有斜插孔5,张力辅钉穿过斜插孔与压力主钉交叉设置。
手术时具体实施方法如下:
克氏针定位:确定压力主钉位置及方向,打入克氏针;
修整股骨头:按照需要修整股骨头;
测量长度:测量孔深,确定压力主钉、张力辅钉长度;
安装假体中间体:安装假体中间体;
安装压力主钉:按照克氏针方向拧入压力主钉,钉子前端超过斜孔部分均为螺纹,螺纹与皮质骨和松质骨均有配合,增加稳定性,后端螺纹与假体中间体配合,压力主钉外端不可超出假体中间体外表面,以免影响股骨假体的安装及稳定性;
安装张力辅钉:按照张力辅钉方向拧入张力辅钉,钉子前端超过斜孔部分均为螺纹,螺纹与皮质骨和松质骨均有配合,增加稳定性,后端螺纹与假体中间体配合,张力辅钉外端不可超出假体中间体外表面,以免影响股骨假体的安装及稳定性;
安装股骨头假体:股骨头假体与假体中间体锥连接;
将股骨头假体与髋臼杯假体球面配合安装。
本发是一种方便手术操作的仿生型表面髋关节假体,设置一个假体中间体,与股骨头假体形成锥面连接,并通过压力主钉与张力辅钉的设置,方便手术操作,而且可以很好地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、股骨头假体及假体中间体预估的接触面均为3D打印骨小梁结构,其应力分布更为优化,最大应力值明显减小,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,且颗粒残留低、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。
并且由于髋臼杯假体及股骨头假体均为锆铌合金材料且表面经氧化处理,其耐磨性、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。
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。
对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0.01~4.22MPa,因此,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集中损伤小。
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0.01~4.97MPa,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损伤较小。
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,本发明是一种方便手术操作的仿生型表面髋关节假体,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 (5)
1.一种方便手术操作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、假体中间体、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,所述假体中间体设于股骨头假体内且假体中间体外表面与股骨头假体内表面通过锥面配合,髋臼杯假体、股骨头假体及假体中间体与骨的接触面均为3D打印骨小梁结构,所述压力主钉与张力辅钉后端部均与假体中间体连接。
2.根据权利要求1所述的一种方便手术操作的仿生型表面髋关节假体,其特征在于,所述髋臼杯假体、股骨头假体、假体中间体、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所述的一种方便手术操作的仿生型表面髋关节假体,其特征在于,所述假体中间体为碗状结构,碗状结构的下部与股骨头假体的内表面形成锥面配合且在碗状结构的侧面开设两个螺纹孔,压力主钉与张力辅钉后端部均在螺纹孔处与假体中间体通过螺纹连接,压力主钉与张力辅钉前端部均设有外螺纹。
4.根据权利要求1所述的一种方便手术操作的仿生型表面髋关节假体,其特征在于,所述假体中间体为锥台形与股骨头假体内表面配合,锥台底面开设有张力辅钉螺纹通孔,压力主钉与假体中间体一体成型且前端部设有外螺纹,所述张力辅钉和压力主钉为全螺纹结构且张力辅钉后端部安装在张力辅钉螺纹孔内。
5.根据权利要求3或4所述的一种方便手术操作的仿生型表面髋关节假体,其特征在于,所述压力主钉在靠近股骨颈的位置开设有斜插孔,张力辅钉穿过斜插孔与压力主钉交叉设置。
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