CN111265344B - 一种纤维增强3d打印聚合物盆骨替代物 - Google Patents
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Abstract
一种纤维增强3D打印聚合物盆骨替代物,分为不含髋臼盆骨替代物和含髋臼盆骨替代物;不含髋臼盆骨替代物包括增强承重部分、边界部分和非承重部分,含髋臼盆骨替代物包括增强承重部分、边界部分、非承重部分和髋臼杯部分;边界部分与骨连接,非承重部分起保持盆骨原始解剖形貌的作用,增强承重部分内部有增强纤维,起到增强替代物抗拉和抗弯强度的作用,根据盆骨整体力线中缺损替代部分的力线方向确定增强纤维走向,根据盆骨服役状态下的受力分布确定增强纤维的纤度和体积,使盆骨替代物在人体生理载荷下具有足够的安全系数;本发明增强承重部分通过设计外形和内部的增强纤维的走向、纤度和体积,满足各种步态条件下人体盆骨部位的力学环境要求。
Description
技术领域
本发明属于盆骨假体技术领域,具体涉及一种纤维增强3D打印聚合物盆骨替代物。
背景技术
在日常活动中,盆骨将人体上身载荷传递到下肢,是人体骨骼结构的重要组成部分。然而,因伤病造成盆骨损伤后,需要对损伤部位进行切除和重建,盆骨假体重建随着材料和制造技术的发展成为主流的盆骨重建方式。目前所使用的假体材料大多是以钛合金为代表的金属合金,由于其较高的弹性模量,会产生应力遮挡效应,进而引起骨流失和假体松动等并发症。
以聚醚醚酮(PEEK)为代表的具有优良生物相容性的高分子材料,因具备良好的生物相容性和耐磨性,已经在椎间融合器等领域得到了成功应用。与钛合金相比,PEEK材料的弹性模量与皮质骨相近,且具有良好的放射线透过性,能在很大程度上避免应力遮挡效应和CT的伪影问题;但聚合物材料的在静强度和疲劳强度远低于金属材料,限制了其在临床医学上的应用。
发明内容
为了克服上述现有技术的缺点,本发明的目的在于提供了一种纤维增强3D打印聚合物盆骨替代物,通过在替代物中沿人体盆骨力线方向定向铺设增强纤维,提高替代物的许用强度;通过在替代物和骨连接的部位使用多孔结构和生物活性颗粒,提高聚合物的生物活性,提高替代物的早期骨整合能力,满足人体盆骨部位的力学性能要求并能够与周围骨紧密整合。
为了达到上述目的,本发明采取如下技术方案:
一种纤维增强3D打印聚合物盆骨替代物,分为不含髋臼盆骨替代物和含髋臼盆骨替代物两种类别;不含髋臼盆骨替代物包括增强承重部分1、边界部分2和非承重部分3,含髋臼盆骨替代物包括增强承重部分1、边界部分2、非承重部分3和髋臼杯部分4;边界部分2与剩余骨连接,非承重部分3起保持盆骨原始解剖形貌的作用,非承重部分3的形态根据同类型临床需求来确定;增强承重部分1内部有增强纤维5,起到增强替代物抗拉和抗弯强度的作用;髋臼杯部分4内部亦含有增强纤维5。
所述增强承重部分1根据几何形貌及所受应力的要求,进行内部的增强纤维5的走向、纤度和体积的设计,进而满足各种步态条件下人体盆骨部位的力学环境要求;增强承重部分1内的增强纤维5的走向和盆骨整体力线中缺损替代部分的力线方向相一致,增强纤维5的纤度和体积根据盆骨服役状态下的受力分布确定。
所述边界部分2与剩余骨接触的界面为孔隙率范围在0-100%的多孔结构,边界部分2的表层能够复合厚度为1-10mm的生物活性颗粒,边界部分2与剩余骨的固定方式为螺钉固定或翼板连接。
所述生物活性颗粒为羟基磷灰石、碳酸钙、磷酸钙、氧化锆、氧化钛、硫酸钡或生物玻璃,以提高其生物活性和骨组织结合能力。
所述髋臼杯部分4内部的增强纤维5的铺设方向包括三角形、弧形、环状、网状、放射状、螺旋状或上述形状的组合。
所述增强纤维5是连续纤维或短切纤维,纤维含量范围为0wt%-80wt%,纤维材料为碳纤维、玻璃纤维、芳纶纤维或金属纤维。
所述纤维增强3D打印聚合物盆骨替代物的基体使用生物相容性良好的高分子材料,包括聚醚醚酮(PEEK)、聚砜(PSF)。
所述纤维增强3D打印聚合物盆骨替代物通过增材制造技术进行一体化打印或根据假体功能模块分别制造并装配使用。
和现有技术相对比,本发明具有如下优点:
1.本发明的盆骨替代物,其基体使用生物相容性良好的高分子材料,能有效避免因金属材料高弹性模量导致的应力遮挡效应,进而提高假体周围骨的重建效果和假体的远期稳定性;
2.本发明的盆骨替代物,根据盆骨整体力线中缺损替代部分的力线方向确定替代物的纤维走向,根据盆骨服役状态下的受力分布确定增强纤维的纤度和体积,便于在最大程度上发挥增强纤维对替代物力学性能的增强效果,满足复杂人体盆骨部位的力学环境要求;
3.本发明的盆骨替代物,通过在替代物与骨的连接部位使用多孔结构和生物活性颗粒,以提高其生物活性和骨组织结合能力,有助于提高替代物的早期稳定性。
附图说明
图1为本发明不含髋臼盆骨替代物的装配示意图。
图2为本发明不含髋臼盆骨替代物的结构示意图。
图3为图2的A-A(人体矢状面)截面示意图。
图4为图2的B-B(人体横截面)截面示意图。
图5为本发明含髋臼盆骨替代物的装配示意图。
图6为本发明含髋臼盆骨替代物的结构示意图。
图7为图6的][部位放大视图。
具体实施方式
下面结合附图和实施例对本发明做进一步详细介绍,应当指出的是,此处所描述的实施例仅用于说明和解释本发明,但并不限制此发明。
实施例1,以I型假体(髂骨切除)为例,如图1、图2、图3和图4所示,一种纤维增强3D打印聚合物盆骨替代物,盆骨替代物为不含髋臼盆骨替代物,不含髋臼盆骨替代物包括增强承重部分1、边界部分2和非承重部分3;增强承重部分1内部有增强纤维5,起到增强替代物抗拉和抗弯强度的作用;边界部分2与剩余骨连接;非承重部分3为盆骨替代物除去增强承重部分1和边界部分2后的其余部分,起保持盆骨原始解剖形貌的作用,非承重部分3的形态可根据同类型临床需求来确定。
所述增强承重部分1根据几何形貌及所受应力的要求,进行内部的增强纤维5的走向、纤度和体积的设计,进而满足各种步态条件下人体盆骨部位的力学环境要求;如图1所示,所述增强承重部分1内的增强纤维5的走向沿盆骨环,和图中带箭头粗实线的走向一致。
所述增强纤维5的纤度和体积根据盆骨服役状态下的受力分布确定,具体方法如下:建立包括替代物和剩余骨的有限元模型,根据替代物和剩余骨的连接方式和盆骨模型所处人体盆骨部位的力学环境定义载荷和边界条件,进行有限元计算;通过调整增强纤维5的纤度和体积,使替代物有足够的安全储备。
所述边界部分2与剩余骨接触的界面为孔隙率为30%的多孔结构,边界部分2表层可以复合厚度为5mm的生物活性颗粒,边界部分2与剩余骨的固定方式为螺钉固定和翼板连接。
所述纤维增强3D打印聚合物盆骨替代物的基体材料使用聚醚醚酮(PEEK);增强纤维5使用连续碳纤维,纤维含量为40wt%;生物活性颗粒使用羟基磷灰石。
所述纤维增强3D打印聚合物盆骨替代物通过增材制造技术进行一体化打印。
实施例2,以II+III(髋臼+坐骨切除)型假体为例,如图5、图6和图7所示,一种纤维增强3D打印聚合物盆骨替代物,盆骨替代物为含髋臼盆骨替代物,与实施例1中的I型假体的区别在于,含髋臼盆骨替代物的边界部分2与剩余骨的固定方式为螺钉固定;此外,含髋臼盆骨替代物包括髋臼杯部分4,髋臼杯部分4内部含有增强纤维5;增强纤维5的铺设方向为放射状。除连接方式和髋臼杯部分4之外,其余部分与实施例1中描述类似,这里不再赘述。
Claims (5)
1.一种纤维增强3D打印聚合物盆骨替代物,分为不含髋臼盆骨替代物和含髋臼盆骨替代物两种类别,其特征在于:不含髋臼盆骨替代物包括增强承重部分(1)、边界部分(2)和非承重部分(3),含髋臼盆骨替代物包括增强承重部分(1)、边界部分(2)、非承重部分(3)和髋臼杯部分(4);边界部分(2)与剩余骨连接,非承重部分(3)起保持盆骨原始解剖形貌的作用,非承重部分(3)的形态根据同类型临床需求来确定;增强承重部分(1)内部有增强纤维(5),起到增强替代物抗拉和抗弯强度的作用;髋臼杯部分(4)内部亦含有增强纤维(5);
所述增强承重部分(1)根据几何形貌及所受应力的要求,进行内部的增强纤维(5)的走向、纤度和体积的设计,进而满足各种步态条件下人体盆骨部位的力学环境要求;增强承重部分(1)内的增强纤维(5)的走向和盆骨整体力线中缺损替代部分的力线方向相一致,增强纤维(5)的纤度和体积根据盆骨服役状态下的受力分布确定;定向增强纤维(5)的纤度和体积确定过程如下:建立包括替代物和剩余骨的有限元模型,根据人体盆骨部位的力学环境定义载荷和边界条件进行各种步态的有限元计算,按照强度需求得纤维具体参数,并通过调整增强纤维(5)的纤度和体积,使替代物有足够的安全储备;
所述边界部分(2)与剩余骨接触的界面为孔隙率范围在0-100%的多孔结构,边界部分(2)的表层能够复合厚度为1-10mm的生物活性颗粒,边界部分(2)与剩余骨的固定方式为螺钉固定或翼板连接;
所述纤维增强3D打印聚合物盆骨替代物通过增材制造技术进行一体化打印。
2.根据权利要求1所述的一种纤维增强3D打印聚合物盆骨替代物,其特征在于:所述生物活性颗粒为羟基磷灰石、碳酸钙、磷酸钙、氧化锆、氧化钛、硫酸钡或生物玻璃,以提高其生物活性和骨组织结合能力。
3.根据权利要求1所述的一种纤维增强3D打印聚合物盆骨替代物,其特征在于:所述髋臼杯部分(4)内部的增强纤维(5)的铺设方向包括三角形、弧形、环状、网状、放射状、螺旋状或上述形状的组合。
4.根据权利要求1所述的一种纤维增强3D打印聚合物盆骨替代物,其特征在于:所述增强纤维(5)是连续纤维或短切纤维,纤维含量范围为0wt%-80wt%,纤维材料为碳纤维、玻璃纤维、芳纶纤维或金属纤维。
5.根据权利要求1所述的一种纤维增强3D打印聚合物盆骨替代物,其特征在于:所述纤维增强3D打印聚合物盆骨替代物的基体使用生物相容性良好的高分子材料,包括聚醚醚酮(PEEK)、聚砜(PSF)。
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CN109276352A (zh) * | 2018-09-17 | 2019-01-29 | 上海交通大学医学院附属第九人民医院 | 一种3d打印个体化的一体成型金属骨盆翻修假体及其制备方法 |
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