CN105596122A - 一种人工全膝关节假体 - Google Patents
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Abstract
本发明公开了一种人工全膝关节假体，包括依次相连的股骨髁、衬垫和胫骨托，且衬垫的上表面与股骨髁形成滑动配合，而衬垫的下表面与胫骨托配合；股骨髁、衬垫和胫骨托均采用聚醚醚酮或其衍生物制成。本发明提供的人工全膝关节假体具有高耐磨性能、较好的生物相容性和较好的缓冲性能，能够更好地模拟正常膝关节的生物性能，还能改善病人的主观感受，且所述人工全膝关节假体的使用寿命长，翻修率低，不会产生金属离子毒性和过敏反应，不影响透视显影和核磁共振成像。
Description
技术领域
本发明涉及医疗康复器械领域，尤其涉及一种人工全膝关节假体。
背景技术
膝关节为人体最大且构造最复杂，损伤机会亦较多的关节。关节置换是目前改善膝关节功能的常用方法，可以减轻关节疼痛，矫正关节畸形，恢复关节活动度。人工膝关节假体目前常用的材料为CoCrMo合金/UHMWPE摩擦界面，此界面具有较好的摩擦性能且超高分子量聚乙烯提供了一定的缓冲性能，但是长期使用下因聚乙烯的磨损产生的颗粒可以诱导炎性反应，诱发骨溶解并导致假体松动；其次，CoCrMo合金弹性模量大，会产生应力遮挡问题；再次，CoCrMo合金会释放一定量的金属离子，对机体有一定的毒性；另外，金属材料会在X射线下显示伪影，并影响核磁共振的成像，因此迫切需要一种高耐磨、具有较好的生物相容性和较好的缓冲性能且使用寿命长的膝关节假体。
发明内容
本发明要解决的技术问题在于，针对现有技术中人工膝关节假体因易磨损而容易诱导炎性反应、骨溶解并导致假体松动、且会产生应力遮挡问题、对机体有一定的毒性且影响核磁共振成型的上述缺陷，提供一种高耐磨、具有较好的生物相容性和较好的缓冲性能、能够更好地模拟正常膝关节的生物性能、改善病人的主观感受、延长使用寿命并降低翻修率的人工全膝关节假体。
本发明为解决上述技术问题，其所采用的技术方案如下：
一种人工全膝关节假体，包括依次相连的股骨髁、衬垫和胫骨托，且衬垫的上表面与股骨髁形成滑动配合，而衬垫的下表面与胫骨托配合；
股骨髁、衬垫和胫骨托均采用聚醚醚酮或其衍生物制成。
在本发明所述人工全膝关节假体中，上述衬垫的上表面与股骨髁形成滑动配合，而衬垫的下表面与胫骨托配合，不仅使得所述人工全膝关节假体能够代替人体全膝关节以实现人体全膝关节该有的功能，而且因为衬垫的上表面与股骨髁之间为滑动配合、衬垫与胫骨托之间的接触面为光滑面，有助于减缓股骨髁与衬垫、胫骨托与衬垫之间的相互磨损，延长了所述人工全膝关节假体的使用寿命，降低了其翻修率。
上述股骨髁、衬垫和胫骨托均采用聚醚醚酮或其衍生物制成，聚醚醚酮或其衍生物具有较低的摩擦系数、较低的磨损率和理想的弹性模量，这样使得所述人工全膝关节假体具有高耐磨性能和较好的缓冲性能，大大降低了磨损，进而有助于降低骨溶解和所述人工全膝关节假体松动的发生率，并能够更好地模拟正常膝关节的生物性能；除此之外，聚醚醚酮或其衍生物还具有良好的生物相容性，这样有助于提高所述人工全膝关节假体的生物相容性，有助于改善病人的主观感受。另外，因为上述股骨髁、衬垫和胫骨托均采用聚醚醚酮或其衍生物制成，故使得所述人工全膝关节假体内不含金属材料，不会产生金属离子毒性和过敏反应，不影响透视显影和核磁共振成像。
作为对本发明所述人工全膝关节假体的一种改进，上述股骨髁的弹性模量的取值范围为10GPa～25GPa。将该股骨髁的弹性模量的取值范围限定为10GPa～25GPa，这样的设计使得股骨髁的弹性模量与人体骨组织相近，可以避免应力遮挡，能对人体骨组织起到保护作用，一方面，可避免产生磨损颗粒，有助于降低骨溶解和所述人工全膝关节假体松动的发生率，另一方面，有助于进一步延长所述人工全膝关节假体的使用寿命，降低了其翻修率。如若股骨髁的弹性模量小于10GPa，则会使得所述人工全膝关节假体的强度太差，如若股骨髁的弹性模量大于25GPa，则会导致应力遮挡，也就是说，将股骨髁的弹性模量的取值范围限定为10GPa～25GPa，使得所述人工全膝关节假体能够模拟人体骨骼的性能，在保证其强度的同时避免应力遮挡。
作为对本发明所述人工全膝关节假体的一种改进，上述股骨髁的下表面设有髌骨滑槽。股骨髁下表面设置的髌骨滑槽，能够使得股骨髁与髌骨轨迹贴合，从而防止髌骨嵌顿或磨损。
作为对本发明所述人工全膝关节假体的一种改进，所述股骨髁的上表面设有股骨髁稳定结构。
作为对本发明所述人工全膝关节假体的一种改进，上述衬垫顶端边缘设有髌骨槽。该衬垫顶端边缘设置的髌骨槽有利于髌韧带力量的传递，也使得衬垫能够与髌骨轨迹贴合，从而防止髌韧带磨损。
在本发明所述人工全膝关节假体中，衬垫上还设有前唇，且该前唇位于上述髌骨槽的上方位置，该前唇能够与股骨髁外侧贴合，使得所述人工全膝关节假体具有较高的伸直位稳定性。
作为对本发明所述人工全膝关节假体的一种改进，上述胫骨托的弹性模量的取值范围为10GPa～25GPa。同上所述，将胫骨托的弹性模量限定为10GPa～25GPa，这样的设计使得胫骨托的弹性模量与人体骨组织相近，可以避免应力遮挡，能对人体骨组织起到保护作用，一方面，可避免产生磨损颗粒，有助于进一步降低骨溶解和所述人工全膝关节假体松动的发生率，另一方面，有助于进一步延长所述人工全膝关节假体的使用寿命，其翻修率也大幅降低。如若胫骨托的弹性模量小于10GPa，则会使得所述人工全膝关节假体的强度太差，如若胫骨托的弹性模量大于25GPa，则会导致应力遮挡，即，将胫骨托的弹性模量的取值范围限定为10GPa～25GPa，使得所述人工全膝关节假体能够模拟人体骨骼的性能，在保证其强度的同时避免应力遮挡。
作为对本发明所述人工全膝关节假体的一种改进，上述胫骨托包括胫骨平台及设置在该胫骨平台底端的固定轴，且该固定轴的外侧表面设有至少一对固定翼。该固定轴、固定翼可以与松质骨稳定结合，起到稳定结合所述人工全膝关节假体与松质骨的作用；该固定翼可以防止该胫骨托旋转，使得所述人工全膝关节假体具有较好的早期稳定性。
在本发明所述人工全膝关节假体中，上述衬垫与胫骨托之间设有限定组件，该限定组件可以防止衬垫脱出，起到稳定衬垫与胫骨托之间连接的作用。
上述限定组件包括设置在衬垫上的衬垫限制结构和设置在胫骨托顶端的防脱结构，且该衬垫限制结构与防脱结构相互配合。当衬垫限制结构与防脱结构相互配合时，便可达到将衬垫与胫骨托稳固结合在一起的目的，使用十分方便。
作为对本发明所述人工全膝关节假体的一种改进，上述股骨髁和胫骨托的硬度均大于衬垫的硬度。这样的设计使得衬垫作为被磨损方，在保证良好缓冲和关节功能的同时减缓股骨髁与衬垫、胫骨托与衬垫之间的磨损，有助于提升所述人工全膝关节假体的缓冲性能；如若股骨髁和胫骨托的硬度均与衬垫的硬度相同，则股骨髁与衬垫、胫骨托与衬垫之间的磨损会相当严重；如若股骨髁和胫骨托的硬度均小于衬垫的硬度，则会使得股骨髁在磨损过程中发生变形，使得所述人工全膝关节假体的关节功能受到严重影响。
作为对本发明所述人工全膝关节假体的一种改进，上述股骨髁、衬垫或胫骨托表面镶嵌有显影物质。在安装所述人工全膝关节假体后，股骨髁、衬垫或胫骨托表面镶嵌的显影物质方便了对所述人工全膝关节假体进行透视定位。
另外，在本发明所述技术方案中，凡未作特别说明的，均可通过采用本领域中的常规技术手段来实现。
因此，本发明提供的人工全膝关节假体具有高耐磨性能、较好的生物相容性和较好的缓冲性能，能够更好地模拟正常膝关节的生物性能，还能改善病人的主观感受，且所述人工全膝关节假体的使用寿命长，翻修率低，不会产生金属离子毒性和过敏反应，不影响透视显影和核磁共振成像。
附图说明
下面将结合附图及实施例对本发明作进一步说明，附图中：
图1是实施例一中人工全膝关节假体的装配图；
图2是实施例一中人工全膝关节假体的爆炸图；
图3是实施例一中股骨髁的结构示意图；
图4是图3的俯视图；
图5是实施例一中衬垫的结构示意图；
图6是实施例一中胫骨托的结构示意图；
图7是实施例二中人工全膝关节假体的装配图；
图8是实施例二中人工全膝关节假体的爆炸图；
图9是实施例二中股骨髁的结构示意图；
图10是图9的俯视图；
图11是实施例二中衬垫的结构示意图；
图12是实施例二中胫骨托的结构示意图；
现将附图中的标号说明如下：1为股骨髁，1.1为髌骨滑槽，1.2为股骨髁稳定结构，2为衬垫，2.1为髌骨槽，2.2为前唇，2.3为窝柱结构，2.4为椭柱状凸，2.5为条状凸，2.6为锁定槽，3为胫骨托，3.1为胫骨平台，3.2为固定轴，3.3为固定翼，3.4凹槽，3.5为固定槽，3.6为锁定扣，4为显影物质。
具体实施方式
为了使本发明的目的、技术方案及优点更加清楚明白，以下结合附图及实施例，对本发明进行进一步详细说明。应当理解，此处所描述的具体实施例仅用以解释本发明，并不用于限定本发明。
实施例一：
一种人工全膝关节假体，该人工全膝关节假体为交叉韧带保留型假体，即CR假体，如图1和图2所示，包括依次相连的股骨髁1、衬垫2和胫骨托3，且该衬垫2的上表面与股骨髁1形成滑动配合，而该衬垫2的下表面与胫骨托3配合，该衬垫2与胫骨托3的接触面是光滑面。
上述股骨髁1、衬垫2和胫骨托3均采用聚醚醚酮或其衍生物制成，该聚醚醚酮的衍生物可为碳纤维增强聚醚醚酮、玻璃纤维增强聚醚醚酮等。
上述股骨髁1的弹性模量的取值范围为10GPa～25GPa；如图3和图4所示，该股骨髁1的下表面和上表面分别设有髌骨滑槽1.1和股骨髁稳定结构1.2，且该股骨髁1表面还镶嵌有显影物质4。
如图5所示，该衬垫2的顶端边缘上设有髌骨槽2.1，该衬垫2表面也镶嵌有显影物质4。
上述胫骨托3的弹性模量的取值范围为10GPa～25GPa；如图6所示，该胫骨托3包括胫骨平台3.1及设置在该胫骨平台3.1底端的固定轴3.2，且该固定轴3.2的外侧表面设有至少一对固定翼3.3，具体可为一对固定翼3.3；另外，该胫骨托3的表面也镶嵌有显影物质4。
上述衬垫2与胫骨托3之间还设有限定组件，该限定组件包括设置在衬垫2上的衬垫限制结构和设置在胫骨托3顶端的防脱结构，且该衬垫限制结构与防脱结构相互配合，从而允许衬垫2在一定范围内旋转，具体可参照图5和图6：该衬垫限制结构为设置在衬垫2底端的椭柱状凸2.4，该防脱结构包括设置在胫骨托3顶端的凹槽3.4，且该椭柱状凸2.4与凹槽3.4相互配合。
在本实施例中，上述股骨髁1和胫骨托3的硬度均大于衬垫2的硬度。
实施例二：
一种人工全膝关节假体，该人工全膝关节假体为后稳定型假体，即PS型假体，采用固定平台设计，包括依次相连的股骨髁1、衬垫2和胫骨托3，且如图7和图8所示，该衬垫2的上表面与股骨髁形成滑动配合，而该衬垫的下表面与胫骨托配合，且该衬垫2与胫骨托3的接触面是光滑面。
上述股骨髁1、衬垫2和胫骨托3均采用聚醚醚酮或其衍生物(比如碳纤维增强聚醚醚酮、玻璃纤维增强聚醚醚酮等)制成。
上述股骨髁1的弹性模量的取值范围为10GPa～25GPa；如图9和图10所示，该股骨髁1的下表面和上表面分别设有髌骨滑槽1.1和股骨髁稳定结构1.2，且该股骨髁1表面还镶嵌有显影物质4。
如图11所示，该衬垫2上设有髌骨槽2.1和前唇2.2，其中，髌骨槽2.1位于该衬垫2的顶端边缘，该前唇2.2位于髌骨槽2.1的上方位置；该衬垫2的上表面还设有窝柱结构2.3，该窝柱结构可以防止股骨髁1在高度屈曲状态下向前滑脱，即有助于维持人工全膝关节假体的稳定性；另外，该衬垫2表面也镶嵌有显影物质4。
上述胫骨托3的弹性模量的取值范围为10GPa～25GPa；如图12所示，该胫骨托3包括胫骨平台3.1及设置在该胫骨平台3.1底端的固定轴3.2，且该固定轴3.2的外侧表面设有至少一个固定翼3.3，具体可为一对固定翼3.3；另外，该胫骨托3的表面也镶嵌有显影物质4。
上述衬垫2与胫骨托3之间还设有限定组件，该限定组件包括设置在衬垫2上的衬垫限制结构和设置在胫骨托3顶端的防脱结构，且该衬垫限制结构与防脱结构相互配合，具体可参照图11和图12：该衬垫限制结构为设置在衬垫2底端的条状凸2.5和锁定槽2.6，该防脱结构包括设置在胫骨托3顶端的固定槽3.5和锁定扣3.6，该衬垫2可沿固定槽3.5从前向后滑入，条状凸2.5与固定槽3.5相互配合，而锁定扣3.6与锁定槽2.6相互锁定，从而稳定衬垫2，防止旋转和脱出。
在本实施例中，上述股骨髁1和胫骨托3的硬度也均大于衬垫2的硬度。
应当理解的是，对本领域普通技术人员来说，可以根据上述说明加以改进或变换，而所有这些改进和变换都应属于本发明所附权利要求的保护范围。
Claims (9)
1.一种人工全膝关节假体，其特征在于，包括依次相连的股骨髁(1)、衬垫(2)和胫骨托(3)，且所述衬垫(2)的上表面与所述股骨髁(1)形成滑动配合，而所述衬垫(2)的下表面与所述胫骨托(3)配合；
所述股骨髁(1)、衬垫(2)和胫骨托(3)均采用聚醚醚酮或其衍生物制成。
2.根据权利要求1所述的人工全膝关节假体，其特征在于，所述股骨髁(1)的弹性模量的取值范围为10GPa～25GPa。
3.根据权利要求1所述的人工全膝关节假体，其特征在于，所述股骨髁(1)的下表面设有髌骨滑槽(1.1)。
4.根据权利要求1所述的人工全膝关节假体，其特征在于，所述股骨髁(1)的上表面设有股骨髁稳定结构(1.2)。
5.根据权利要求1所述的人工全膝关节假体，其特征在于，所述衬垫(2)顶端边缘设有髌骨槽(2.1)。
6.根据权利要求1所述的人工全膝关节假体，其特征在于，所述胫骨托(3)的弹性模量的取值范围为10GPa～25GPa。
7.根据权利要求1所述的人工全膝关节假体，其特征在于，所述胫骨托(3)包括胫骨平台(3.1)及设置在所述胫骨平台(3.1)底端的固定轴(3.2)，且所述固定轴(3.2)的外侧表面设有至少一对固定翼(3.3)。
8.根据权利要求1所述的人工全膝关节假体，其特征在于，所述股骨髁(1)和胫骨托(3)的硬度均大于所述衬垫(2)的硬度。
9.根据权利要求1所述的人工全膝关节假体，其特征在于，所述股骨髁(1)、衬垫(2)或胫骨托(3)表面镶嵌有显影物质(4)。
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