CN111317868A - 一种定向增强3d打印聚合物股骨近端替代物及其设计方法 - Google Patents
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Abstract
一种定向增强3D打印聚合物股骨近端替代物及其设计方法，替代物包括主体部分和固定部分；主体部分的外形与人体缺损股骨近端的形貌相匹配，主体部分和固定部分内部有增强纤维，增强纤维的铺设方向与股骨近端替代物的主应力迹线方向一致，增强纤维的分布密度和分布区域满足股骨近端替代物的拉伸和弯曲强度要求，起到提高股骨近端替代物抗拉和抗弯强度的作用；主体部分和固定部分内部有增强颗粒，增强颗粒的含量满足股骨近端替代物压缩强度要求，起到提高股骨近端替代物抗压强度的作用；本发明使用主应力迹线作为高分子聚合物基体材料中的增强纤维排布方式的依据，使替代物既获得了高分子聚合物的轻质、低模量优势，又具有足够的强度。
Description
技术领域
本发明属于个性化骨替代物技术领域，具体涉及一种定向增强3D打印聚合物股骨近端替代物及其设计方法。
背景技术
由于股骨头坏死、股骨近端肿瘤或事故等原因造成的人体股骨近端严重骨缺损对病人的运动功能有重大影响，严重者甚至危及生命，切除近端股骨并使用人工材料进行重建是解决严重骨缺损的重要手段。采用金属3D打印技术对缺损骨骼进行个性化重建是近年来修复严重骨缺损的新方法，但金属骨替代物存在弹性模量大、重量大、成本高和伪影等问题，因此以聚醚醚酮、聚乙烯等为代表的可植入的高分子聚合物材料被认为是可以替代金属材料的下一代骨植入物材料，相比于金属材料，高分子聚合物材料的优势在于力学性能接近于人体骨、密度低、比强度高且CT下不显影，已在胸肋骨、颅颌面、肩胛骨替代物等有所应用。
目前，高分子聚合物材料在人体下肢承力部位的替代物中尚无应用，主要是由于下肢长骨及关节承担人体运动载荷，以股骨近端假体为例，单纯使用高分子聚合物材料对股骨近端进行重建可能会面临假体强度不足的问题，纤维增强是提高高分子聚合物材料强度的重要手段，但纤维增强复合材料的力学性能通常与内部纤维排列方向密切相关，呈现各向异性，难以适应骨替代物在人体内的复杂受力情况。
发明内容
为了克服上述现有技术存在的缺点，本发明的目的在于提供一种定向增强3D打印聚合物股骨近端替代物及其设计方法，使股骨近端替代物内部的增强纤维排布方向适应自身受力情况，提高替代物的安全性。
为了达到上述目的，本发明采取的技术方案为：
一种定向增强3D打印聚合物股骨近端替代物，包括主体部分1和固定部分，主体部分1的外形与人体缺损股骨近端的形貌相匹配，主体部分1和固定部分内部有增强纤维3，增强纤维3的铺设方向与股骨近端替代物的主应力迹线方向一致，增强纤维3的分布密度和分布区域满足股骨近端替代物的拉伸和弯曲强度要求；所述主体部分1和固定部分内部有增强颗粒4，增强颗粒4的含量满足股骨近端替代物压缩强度要求。
所述固定部分采用髓内针结构2-1或翼板结构2-2。
所述增强纤维3的铺设方向的设计方法为：建立包括股骨近端替代物和残余股骨的股骨近端有限元模型，根据患者股骨近端的生物力学环境为有限元模型定义载荷和边界条件，进行有限元计算并提取计算结果的主应力迹线，将所有主应力迹线根据方向划分为若干主应力迹线束，主应力迹线束方向即为增强纤维3的铺设方向。
所述增强纤维3的分布密度和分布区域的设计方法为：首先建立增强纤维3的分布密度α与许用拉伸强度[σ]的强度关系函数[σ]＝f(α)，以及增强纤维3的分布密度α与等效弹性模量E的模量关系函数E＝g(α)；为每一主应力迹线束赋予初始增强纤维分布密度αi，i为主应力迹线束的序号，并根据模量关系函数计算每一主应力迹线束的等效弹性模量Ei；在股骨近端有限元模型中，使用每一主应力迹线束的等效弹性模量Ei为股骨近端替代物内的增强纤维3的分布区域赋予弹性模量，并实施有限元计算；在有限元计算的结果中提取每一主应力迹线束的最大应力σi,max，并根据强度关系函数计算每一主应力迹线束的许用拉伸强度[σi]，根据公式
计算每一主应力迹线束的安全系数Ni；调整所有主应力迹线束的增强纤维3的分布密度αi和分布区域的横截面积，使所有主应力迹线束的安全系数Ni大于额定安全系数[N]。
所述增强纤维3的材料为碳纤维、芳纶纤维、玻璃纤维或金属丝纤维合成纤维材料。
所述的增强颗粒4的材料为陶瓷颗粒或金属颗粒，采用具有多材料打印功能的熔融沉积成形3D打印设备制造。
所述定向增强3D打印聚合物股骨近端替代物选用的基体材料为具有生物相容性的高分子聚合物材料。
本发明的优点和效果在于：
1.本发明的股骨近端替代物具有较高的个性化适配程度，可用于各类患者。由于患者的骨骼形态和病理特征等差异，其所需的替代物需根据实际情况进行个性化定制，本发明能够满足替代物的形状个性化重建。
2.本发明使用主应力迹线作为高分子聚合物基体材料中的增强纤维排布方式的依据，能够最大程度上利用纤维在拉伸方向上的高强度，使替代物既获得了高分子聚合物的轻质、低模量优势，又具有足够的强度。
3.本发明使用个性化的有限元模型对替代物中的主应力迹线进行计算，能够得到适用于个体化患者的主应力迹线及增强纤维排布方式，所设计制备的替代物具有力学个性化特征。
附图说明
图1为本发明髓内针结构的示意图。
图2为本发明翼板结构的示意图。
图3为本发明髓内针结构的冠状剖面的增强纤维铺设示意图。
图4为本发明翼板结构的冠状剖面的增强纤维铺设示意图。
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描述，应当理解，此处所描述的实施案例仅用于说明和解释本发明，但本发明的实施方式不仅限于此。
如图1和图2所示，一种定向增强3D打印聚合物股骨近端替代物，包括主体部分1和固定部分(固定部分采用髓内针结构2-1或翼板结构2-2)，主体部分的外形与人体缺损股骨近端的形貌相匹配，主体部分1和固定部分2内部有增强纤维3；如图3和图4所示，增强纤维3的铺设方向与股骨近端替代物的主应力迹线方向一致，增强纤维3的分布密度和分布区域满足股骨近端替代物的拉伸和弯曲强度要求，起到提高股骨近端替代物抗拉和抗弯强度的作用；所述主体部分1和固定部分2内部有增强颗粒4，增强颗粒4的含量满足股骨近端替代物压缩强度要求，起到提高股骨近端替代物抗压强度的作用。
所述增强纤维3的铺设方向的设计方法为：建立包括股骨近端替代物和残余股骨的股骨近端有限元模型，根据患者股骨近端的生物力学环境为有限元模型定义载荷和边界条件，进行有限元计算并提取计算结果的主应力迹线，将所有主应力迹线根据方向划分为若干主应力迹线束，主应力迹线束方向即为增强纤维3的铺设方向。
所述增强纤维3的分布密度和分布区域的设计方法为：首先建立增强纤维3的分布密度α与许用拉伸强度[σ]的强度关系函数[σ]＝f(α)，以及增强纤维3的分布密度α与等效弹性模量E的模量关系函数E＝g(α)；为每一主应力迹线束赋予初始增强纤维分布密度αi(i为主应力迹线束的序号)，并根据模量关系函数计算每一主应力迹线束的等效弹性模量Ei；在股骨近端有限元模型中，使用每一主应力迹线束的等效弹性模量Ei为股骨近端替代物内的增强纤维3的分布区域赋予弹性模量，并实施有限元计算；在有限元计算的结果中提取每一主应力迹线束的最大应力σi,max，并根据强度关系函数计算每一主应力迹线束的许用拉伸强度[σi]，根据公式
计算每一主应力迹线束的安全系数Ni；调整所有主应力迹线束的增强纤维3的分布密度αi和分布区域的横截面积，使所有主应力迹线束的安全系数Ni大于额定安全系数[N]＝2。
所述固定部分2采用髓内针结构2-1或翼板结构2-2。
所述的个性化定向增强可控3D打印聚合物股骨近端替代物选用的基体材料为聚醚醚酮材料，增强纤维3的材料为碳纤维，增强颗粒4的材料为羟基磷灰石陶瓷颗粒，采用具有多材料打印功能的熔融沉积成形3D打印设备制造。
Claims (7)
1.一种定向增强3D打印聚合物股骨近端替代物，包括主体部分(1)和固定部分，其特征在于：主体部分(1)的外形与人体缺损股骨近端的形貌相匹配，主体部分(1)和固定部分内部有增强纤维(3)，增强纤维(3)的铺设方向与股骨近端替代物的主应力迹线方向一致，增强纤维(3)的分布密度和分布区域满足股骨近端替代物的拉伸和弯曲强度要求；主体部分(1)和固定部分内部有增强颗粒(4)，增强颗粒(4)的含量满足股骨近端替代物压缩强度要求。
2.根据权利要求1所述的一种定向增强3D打印聚合物股骨近端替代物，其特征在于：所述固定部分采用髓内针结构(2-1)或翼板结构(2-2)。
3.根据权利要求1所述的一种定向增强3D打印聚合物股骨近端替代物的增强纤维(3)的铺设方向的设计方法，其特征在于：建立包括股骨近端替代物和残余股骨的股骨近端有限元模型，根据患者股骨近端的生物力学环境为有限元模型定义载荷和边界条件，进行有限元计算并提取计算结果的主应力迹线，将所有主应力迹线根据方向划分为若干主应力迹线束，主应力迹线束方向即为增强纤维(3)的铺设方向。
4.根据权利要求1所述的一种定向增强3D打印聚合物股骨近端替代物的增强纤维(3)的分布密度和分布区域的设计方法，其特征在于：首先建立增强纤维(3)的分布密度α与许用拉伸强度[σ]的强度关系函数[σ]＝f(α)，以及增强纤维(3)的分布密度α与等效弹性模量E的模量关系函数E＝g(α)；为每一主应力迹线束赋予初始增强纤维分布密度αi，i为主应力迹线束的序号，并根据模量关系函数计算每一主应力迹线束的等效弹性模量Ei；在股骨近端有限元模型中，使用每一主应力迹线束的等效弹性模量Ei为股骨近端替代物内的增强纤维(3)的分布区域赋予弹性模量，并实施有限元计算；在有限元计算的结果中提取每一主应力迹线束的最大应力σi,max，并根据强度关系函数计算每一主应力迹线束的许用拉伸强度[σi]，根据公式
计算每一主应力迹线束的安全系数Ni；调整所有主应力迹线束的增强纤维(3)的分布密度αi和分布区域的横截面积，使所有主应力迹线束的安全系数Ni大于额定安全系数[N]。
5.根据权利要求1所述的一种定向增强3D打印聚合物股骨近端替代物，其特征在于：所述增强纤维(3)的材料为碳纤维、芳纶纤维、玻璃纤维或金属丝纤维合成纤维材料。
6.根据权利要求1所述的一种定向增强3D打印聚合物股骨近端替代物，其特征在于：所述的增强颗粒(4)的材料为陶瓷颗粒或金属颗粒，采用具有多材料打印功能的熔融沉积成形3D打印设备制造。
7.根据权利要求1所述的一种定向增强3D打印聚合物股骨近端替代物，其特征在于：所述定向增强3D打印聚合物股骨近端替代物选用的基体材料为具有生物相容性的高分子聚合物材料。
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