CN107693164A - 一种3d打印髋臼内衬的防脱位髋关节假体及其制造方法 - Google Patents
一种3d打印髋臼内衬的防脱位髋关节假体及其制造方法 Download PDFInfo
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Abstract
一种3D打印髋臼内衬的防脱位髋关节假体，包括髋臼内衬，其特征在于，所述髋臼内衬上设有半球形槽，半球形槽的边缘一体延伸成型有超半径扣边，髋臼内衬的内部设有股骨头假体，所述股骨头假体呈球形，股骨头假体与髋臼内衬的内部空间大小一致，超半径扣边的开口的直径小于股骨头假体的直径，股骨头假体上设有股骨颈假体。
Description
技术领域
本发明涉及医疗领域，具体涉及一种3D打印髋臼内衬的防脱位髋关节假体及其制造方法。
背景技术
人工全髋关节置换术已经作为治疗老年髋关节重度骨关节炎、股骨头坏死晚期及股骨颈骨折常规手术，其手术疗效已得到临床的肯定，从最早期60年代髋关节置换手术治疗高龄患者重度骨关节炎病，到现在年轻患者通过髋关节置换术恢复髋关节良好功能，生物工程学及材料学的进步无疑起着举足轻重的作用，但是髋关节置换术后也存在一些并发症，诸如无菌性松动、假体周围感染及髋关节置换术后脱位。既往研究报道髋关节置换术后假体脱位发生率为1% ～3%，仅次于无菌性松动，人工半骨盆置换术后人工髋关节脱位的发生率高达8.3%，髋关节翻修手术后的脱位率则可高达5% ～ 20%，此外文献也报道髋关节置换术后初次脱位患者再次出现假体脱位的概率高达55%。再次脱位后保守或翻修手术不仅增加患者住院时间,影响术后功能恢复，同时也造成医疗资源额外消耗。既往研究已经明确指出髋关节置换术后脱位的众多影响因素，包括患者自身因素、假体设计以及手术技术等。因此我们可以通过改善假体设计来预防髋关节置换术后脱位。从力学上讲，髋关节脱位是股骨头中心先垂直再平行于髋臼表面的移动，是促进和防止脱位的两种力量相互对抗的结果，髋关节活动超过一定范围就会出现小转子或股骨假体与髋臼及其周围软组织的撞击，如果防止脱位的力量不足以阻挡这一倾向，就会发生脱位。
另外髋关节的稳定与关节的包容及周围软组织的张力有关系，如果关节包容关系不佳比如髋臼或者股骨柄的前倾或者髋臼外展位置放置不佳就会导致髋臼与股骨头包容差，日常活动所需的髋关节活动范围就可能导致撞击从而发生脱位。此外髋关节周围软组织的张力是对抗脱位的主要因素，如果患者因为神经肌肉方面的原因导致髋关节周围软组织张力差，那么髋关节的稳定性就差，从而导致脱位。此外，目前常规髋关节假体使用髋臼内衬小半径设计，为的是方便术中股骨头打入，但是这种设计不包含防脱位机制，仅靠髋臼假体及股骨头的包容关系及周围软组织张力进行约束，这种假体设计无疑会增加术后假体脱位率。为此，部分厂家通过增加股骨头直径以及增加髋臼内衬高边来预防髋关节脱位。机制原理为:1.股骨头越大，发生脱位所需的跳出距离就越大，髋关节越稳定，但是也存在弊端。首先，增大股骨头直径势必会减少髋臼内衬厚度，从而影响髋臼内衬的寿命。再者，既往研究发现增大股骨头的直径会增加髋臼内衬与股骨头之间的磨损，从而影响假体的寿命。2.增加髋臼内衬局部高边将髋臼内衬形成超半径，这样可以增加髋臼内衬对股骨头的包容，但是目前髋臼内衬与股骨头是分体制造，考虑到术中股骨头的打入，其髋臼内衬高边设计有限，其结果也是只能一定程度减少脱位发生。综上所述，目前髋关节置换术后防脱位技术效果有限，存在弊端。
此外，髋部或者股骨近端肿瘤患者髋关节周围软组织功能很差，导致术后脱位率明显高于普通髋关节置换。髋臼及股骨头假体均为分体锻造，髋关节假体为超半径设计，所谓超半径设计，即髋关节内衬超过了半球形，对股骨头形成了一定的包被，髋关节内衬向外延伸的超过半径的弧度称为超半径弧度。然而一方面其锁定机制为机械性锁定，依靠髋臼内衬超半径高边对股骨头进行约束，为了能保证术中股骨头的置入，其髋臼内衬超半径范围有限，此外股骨头在术中需外力强行打入，这种置入方式会损坏其锁定机制，临床观察中术后髋关节脱位仍有发生。且初次脱位后容易造成髋关节复发性脱位。
2012年英国著名杂志《经济学人》发表专题报道，指出全球工业正在经历第三次工业革命，其中3D打印最具有代表性。3D打印技术，学术上又称“添加制造”技术，也称为增材制造或者增量制造。美国材料与试验协会（ASTM）定义3D打印技术为基于三维CAD模型数据，通过增加材料逐层制造的方式。3D打印具有如下优势和特点：1.数字制造：借助CAD软件将产品结构数字化，驱动机器设备加工制造器件。2.分层制造：把三维结构物体先分解成二维结构，逐层累加形成三维物品。因此，原理上3D打印技术可以制造出任何复杂的结构。3.堆积制造：“从下而上”的堆积方式对于实现非匀致材料、功能梯度器件更有优势。目前3D打印技术已经能打印出常规制作工艺所无法制造的东西，因此利用该技术我们完全可以实现在股骨头上打印出我们想要的防脱位的髋臼内衬。
通过增加髋臼内衬高边来实现髋臼内衬与股骨头之间牢固锁定，从而有效的防止股骨头脱出。这种设计尤其适应于髋关节周围软组织张力欠佳以及髋部肿瘤术后严重软组织缺损的患者，它可以促进髋关节置换术后患者早期进行功能的康复，从而提高手术效果。
发明内容
本发明的目的就是利用3D打印技术，将髋臼内衬直接打印在股骨头上，整个髋关节为一个整体。且髋臼内衬的超半径包边大幅增大，实现髋臼内衬与股骨头之间牢固锁定，从而有效的防止股骨头脱出。
本发明是通过如下技术方案实现的：
一种3D打印髋臼内衬的防脱位髋关节假体，包括股骨头假体，所述股骨头假体上套有3D打印髋臼内衬，3D打印髋臼内衬包括半球形槽，半球形槽的边缘一体延伸成型有超半径扣边，股骨头假体与3D打印髋臼内衬的内部空间大小一致，超半径扣边的开口的直径小于股骨头假体的直径，股骨头假体上设有股骨颈假体。
进一步的改进，所述3D打印髋臼内衬的内部空间为球缺形，所述超半径扣边的超半径弧度为15°~45°。
进一步的改进，所述超半径扣边的超半径弧度为20°。
进一步的改进，所述超半径扣边包括按顺时针方向排布的第一低点、第一高点、第二低点和第二高点，相邻两点间隔四分之一圆周且相邻两点之间为平滑的曲线连接；超半径扣边在第一低点和第二低点处不超半径，超半径扣边在第一高点处超半径弧度为10°-40°，超半径扣边在第二高点处超半径弧度为5°-25°。
进一步的改进，第一高点和第二高点处的超半径弧度之和小于45°。
进一步的改进，所述3D打印髋臼内衬为高交联聚乙烯材料制成。
进一步的改进，所述股骨头假体为陶瓷材料或金属材料制成。
一种3D打印髋臼内衬的防脱位髋关节假体的制造方法，包括如下步骤：
步骤一）根据规格制造出股骨头假体；
步骤二）根据股骨头假体的大小设计出3D打印髋臼内衬的立体模型，将股骨头假体放入3D打印机，采用高交联聚乙烯在股骨头假体的外部打印出3D打印髋臼内衬；
步骤三）在股骨头假体上组装股骨颈假体。
与现有技术相比，本发明具有以下优点：
本设计通过改变既往髋臼内衬及股骨头分体锻造制造工艺，通过3D打印技术将髋臼内衬直接打印在股骨头上，产品一体成型，不需要考虑股骨头置入技术，可以在保证髋关节活动度前提下，最大程度的增加内衬的高边及超半径度数，这样可以更加有效的增加髋臼内衬与股骨头之间的约束，防止脱位的发生。
附图说明
图1为实施例1示意图；
图2为实施例1纵切面示意图；
图3为实施例2示意图；
图4为实施例2纵切面示意图；
图5为实施例2纵向活动范围示意图；
图6为实施例2横向活动范围示意图。
具体实施方式
实施例1
如图1和图2所示的髋关节假体，包括髋臼内衬，包括股骨头假体3，所述股骨头假体上套有3D打印髋臼内衬，3D打印髋臼内衬包括半球形槽1，半球形槽1的边缘一体延伸成型有超半径扣边2，股骨头假体3与3D打印髋臼内衬1的内部空间大小一致，超半径扣边2的开口的直径小于股骨头假体3的直径，股骨头假体3上设有股骨颈假体。（剖面图中股骨头中间的方形槽即为安装股骨颈的位置）。3D打印髋臼内衬1为高交联聚乙烯材料制成，股骨头假体采用金属材料制成。
该假体的制造方法包括如下步骤：
步骤一）根据规格制造出股骨头假体；
步骤二）根据股骨头假体的大小设计出3D打印髋臼内衬的立体模型，将股骨头假体放入3D打印机，采用高交联聚乙烯在股骨头假体的外部打印出3D打印髋臼内衬；
步骤三）在股骨头假体上组装股骨颈假体。
在此实施例中，髋臼内衬上用于置入股骨头假体的内部空间设计为一个球缺形，骨头假体的半径与该球缺的半径基本相同，超半径扣边的超半径弧度为20°，即超半径扣边为半球形槽向外一体延伸20°的弧度所形成，这种超半径设计远远大于当前分体式设计的髋关节假体，因此股骨头假体会被超半径扣边牢固的扣在髋臼内衬里面，不会脱出。超半径弧度的范围可以为15°~45°，如果太小则防脱位效果差，太大则会影响关节的灵活度。
实施例2
如图3和图4所示，在此实施例中髋臼内衬上的超半径扣边为波浪形设计，包括两个高点和两个低点，相邻两点间隔四分之一圆周且相邻两点之间为平滑的曲线连接；超半径扣边在第一低点和第二低点处不超半径，超半径扣边在第一高点处超半径弧度为10°-40°，超半径扣边在第二高点处超半径弧度为5°-25°。且第一高点和第二高点处的超半径弧度之和小于45°。相当于在半球形槽上部和下部一体延伸出两个波浪状的超半径扣边，而在两个波浪的交接处形成左右两个凹槽（图3中髋臼内衬上部波浪形突起为第一高点，凹陷处最低点为第二低点，下部波浪形突起为第二高点，第一低点位置与第二低点对称）。两个波浪状的超半径扣边可以起到防脱位的作用，而左右的两个凹槽增加了髋关节左右的活动范围。而且在股骨头假体打印完成后，可以通过两个凹槽进行打磨加工等操作。
图5和图6展示了实施例2的髋关节假体的活动范围，可见采用实施例2的波浪式超半径扣边设计，能够在完全不影响关节活动的前提下实现股骨头的限位。
Claims (8)
1.一种3D打印髋臼内衬的防脱位髋关节假体，包括股骨头假体，其特征在于，所述股骨头假体上套有3D打印髋臼内衬，3D打印髋臼内衬包括半球形槽，半球形槽的边缘一体延伸成型有超半径扣边，股骨头假体与3D打印髋臼内衬的内部空间大小一致，超半径扣边的开口的直径小于股骨头假体的直径，股骨头假体上设有股骨颈假体。
2.如权利要求1所述的一种3D打印髋臼内衬的防脱位髋关节假体，其特征在于，所述3D打印髋臼内衬的内部空间为球缺形，所述超半径扣边的超半径弧度为15°~45°。
3.如权利要求2所述的一种3D打印髋臼内衬的防脱位髋关节假体，其特征在于，所述超半径扣边的超半径弧度为20°。
4.如权利要求1所述的一种3D打印髋臼内衬的防脱位髋关节假体，其特征在于，所述超半径扣边包括按顺时针方向排布的第一低点、第一高点、第二低点和第二高点，相邻两点间隔四分之一圆周且相邻两点之间为平滑的曲线连接；超半径扣边在第一低点和第二低点处不超半径，超半径扣边在第一高点处超半径弧度为10°-40°，超半径扣边在第二高点处超半径弧度为5°-25°。
5.如权利要求1所述的一种3D打印髋臼内衬的防脱位髋关节假体，其特征在于，第一高点和第二高点处的超半径弧度之和小于45°。
6.如权利要求1所述的一种3D打印髋臼内衬的防脱位髋关节假体，其特征在于，所述3D打印髋臼内衬为高交联聚乙烯材料制成。
7.如权利要求1所述的一种3D打印髋臼内衬的防脱位髋关节假体，其特征在于，所述股骨头假体为陶瓷材料或金属材料制成。
8.一种3D打印髋臼内衬的防脱位髋关节假体的制造方法，其特征在于，包括如下步骤：
步骤一）根据规格制造出股骨头假体；
步骤二）根据股骨头假体的大小设计出3D打印髋臼内衬的立体模型，将股骨头假体放入3D打印机，采用高交联聚乙烯在股骨头假体的外部打印出3D打印髋臼内衬；
步骤三）在股骨头假体上组装股骨颈假体。
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