CN107280816B - 一种髌骨植入体 - Google Patents

一种髌骨植入体 Download PDF

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CN107280816B
CN107280816B CN201610193885.0A CN201610193885A CN107280816B CN 107280816 B CN107280816 B CN 107280816B CN 201610193885 A CN201610193885 A CN 201610193885A CN 107280816 B CN107280816 B CN 107280816B
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pore
patellar implant
patella
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fixing columns
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CN107280816A (zh
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叶雷
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Chongqing Runze Pharmaceutical Co Ltd
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Chongqing Runze Pharmaceutical Co Ltd
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Abstract

本发明公开了一种髌骨植入体，包括用于与髌骨切骨后的剩余髌骨相匹配的主体部，它具有支撑部、设置在所述支撑部与剩余髌骨的贴合面上用于插入所述剩余髌骨的孔位中的固定柱，固定柱不少于2个，支撑部和固定柱均由多孔材料构成，该多孔材料为多级孔材料，它由以材料孔径大小进行分级的各级孔腔，及围绕形成孔腔的各级腔壁构成，每级孔腔均各自相互贯通且各级孔腔相互间也彼此贯通，分级级数至少两级以上，其渗透率大于0.5×10‑9m2；该种髌骨植入体可以承载更多的生长因子等药物，并有较大的渗透率，非常有利于植入后血液的流动，骨组织的长入，加速髌骨植入体与相邻骨组织的有效融合、固定，能满足髌骨修复对髌骨植入体的多功能需求。

Description

一种髌骨植入体
技术领域
本发明涉及医疗器械领域，尤其涉及一种髌骨植入体。
背景技术
髌骨位于膝关节前方，股骨的下端前面，是人体内最大的籽骨，包埋于股四头肌腱内，与股骨的髌面相关节，参与膝关节的构成。髌骨具有保护膝关节，避免股四头肌腱对股骨髁软骨面摩擦的功能，有传递股四头肌的力量，参与构成伸膝装置功能；有维持膝关节在半蹲位的稳定性，防止膝关节过度内收、外展和伸屈活动的功能，以及有车链作用，增加膝关节回转能力的功能。
髌骨主要病症有：髌骨软化症，我国髌骨软化症患病率达36. 2%，髌骨关节骨性关节炎是髌骨软化症的中晚期，发病率为5%左右，在老年人中发病率更高。髌骨骨折由直接或间接暴力联合作用所致，多会造成髌骨横行骨折、垂直型骨折、粉碎性骨折，严重的髌骨骨折可采用部分髌骨切除术或全髌骨切除术。单纯的切除术不利于伸肌结构的恢复，尤其是全切手术往往对患者后期生活质量造成不利影响，越来越多的临床需求要求进行髌骨关节面重建，人工髌骨植入体置换术是解决问题的一个有效手段。
现有人工髌骨假体置换术常用的髌骨植入体材料一般采用为聚乙烯等不可降解材料，常见的髌骨植入体有圆顶帽型。圆顶帽型髌骨植入体的形状的适应性较强、安装方便，但与正常髌骨的形状并不一致，致使安装在人体内的髌骨外壳假体容易被磨损，磨损过程中形成的聚乙烯磨屑可能引起滑膜炎和金属沉着病，对人体造成危害，同时，其材料由于是致密材料，缺乏缓冲功能。
为了克服上述不足，人们提出了用多孔材料制备髌骨植入体，如CN103598935A“髌骨假体结构”公开了一种骸骨假体结构，包括用于与髌骨切骨后的人体，剩余髌骨相匹配的主体部，所述主体部具有与所述人体剩余髌骨相贴的贴合面，所述贴合面上固定设置有用于插入所述人体剩余髌骨的孔位中的固定柱，所述主体部和所述固定柱均具有多孔结构，所述多孔结构具有多个相互连通的孔隙。该髌骨假体结构通过设置具有多孔结构的主体部与固定柱，患者的骨组织可以长入多孔结构中孔隙的内部，通过让骨组织长入主体部的内部及固定柱的内部，可以有效增加主体部与骨组织的结合力，而且材料由于是多孔材料，具有缓冲功能。CN104069542 A“髌骨组织工程支架及其制造材料和制备方法”也公开了一种由镁、铝、锌和锆形成的相互贯通的多个孔洞构成的髌骨植入体，CN103260553B“假体膝盖骨”公开的髌骨植入体的骨头接触侧可以包括促进骨头向内生长的材料如骨小梁金属，即多孔钽。上述技术不足之处在于所用的多孔材料均为单一孔隙的材料，而单一孔隙的材料不足之处在于一方面能负载的生长因子等药物有限，另外其渗透率与人体骨相比较低，不利于血液流动、组织生长，难以满足人工髌骨植入体置换的多功能需求。
发明内容：
本发明的目的是提供一种新的髌骨植入体，它能满足人工髌骨植入体置换对植入体的多功能需求。
本发明目的通过如下技术方案实现：
一种髌骨植入体，包括用于与髌骨切骨后的剩余髌骨相匹配的主体部，所述主体部具有支撑部、设置在所述支撑部与剩余髌骨的贴合面上用于插入所述剩余髌骨的孔位中的固定柱，所述固定柱不少于2个，所述支撑部和所述固定柱均由多孔材料构成，所述多孔材料为多级孔材料，它由以材料孔径大小进行分级的各级孔腔，及围绕形成孔腔的各级腔壁构成，每级孔腔均各自相互贯通且各级孔腔相互间也彼此贯通，分级级数至少两级以上，所述多级孔材料渗透率大于0.5×10-9m2。
进一步说，所述的髌骨植入体，所述固定柱为2个，2个固定柱与所述贴合面接触面的中心的连线穿过所述贴合面重心并位于所述贴合面长轴方向，所述2个固定柱与所述贴合面接触面的中心的距离不小于贴合面最大几何尺寸的50%，从而有助于提高髌骨植入体安装后的稳定性。
进一步说，所述的髌骨植入体，所述固定柱有3个，3个固定柱之间呈三角状排布，3个固定柱与所述贴合面接触面的中心的连线形成的三角形的面积不小于所述贴合面面积的12%，有助于提高髌骨植入体安装后的稳定性。
进一步说，所述的髌骨植入体，所述3个固定柱与所述贴合面接触面的中心的连线形成的三角形为等边三角形，有助于髌骨植入体安装后稳定性更高。
进一步说，所述的髌骨植入体，所述固定柱侧面与所述贴合面为圆角过渡，圆角半径值不小于垂直于固定柱长轴的横截面面积值平方根的0.4倍，使固定柱能承受更大的剪切力。
进一步说，所述的髌骨植入体，所述的多级孔材料的总孔隙率为61%-90%，有助于组织液在植入体中的流动，并具有较好的缓冲功能。
进一步说，所述的髌骨植入体，所述的多级孔材料按照材料孔径大小分为三级，最小级孔腔孔径为纳米级，最大级孔腔孔径为微米级，中间一级孔腔孔径介于最小级孔腔孔径与最大级孔腔孔径之间，这样结构的植入体特别有利于髌骨植入体植入后的骨组织再生。
进一步说，所述的髌骨植入体，所述的具有三级孔的多级孔材料渗透率大于1.5×10-9m2，使植入体渗透率更佳。
进一步说，所述的髌骨植入体，所述的多级孔材料的最大一级孔的孔径为360μm-600μm，特别有利于骨组织长入。
进一步说，所述的髌骨植入体，所述的多级孔材料用医用钽及合金、医用钛及合金、医用铌及合金、医用钴基合金、医用不锈钢、羰基磷灰石、磷酸钙、磷酸三钙、生物活性玻璃、氧化铝、氧化锆制备
本发明的有益效果：
（1）髌骨植入体采用多级孔结构的材料使得腔壁上的小孔腔可以承载更多的生长因子等药物，由于其比表面积大，其承载的药物相对单一孔隙的多孔材料显著增加，加之较大的渗透率，非常有利于植入后血液的流动，骨组织的长入，加速髌骨植入体与与之接触的骨组织的有效融合、固定。而且小孔腔增加了血液流通的通道，有助于增大渗透率，特别是，贯通的小孔腔的毛细作用能显著增大渗透率。
（2）固定柱为2个时，通过将2个固定柱与所述贴合面接触面的中心的距离设定为不小于贴合面最大几何尺寸的50%，提高了髌骨植入体安装后的稳定性。
（3）固定柱为3个时，通过使3个固定柱与所述贴合面接触面的中心的连线形成的三角形的面积不小于所述贴合面面积的12%及三角形设为等边三角形，提高了髌骨植入体安装后的稳定性。
（4）使固定柱侧面与贴合面为圆角过渡，圆角半径值不小于垂直于固定柱长轴的横截面面积值平方根的0.4倍，会使固定柱能承受更大的剪切力。
（5）当孔径大小分为三级，最小级孔腔孔径为纳米级，最大级孔腔孔径为微米级，中间一级孔腔孔径介于最小级孔腔孔径与最大级孔腔孔径之间时，髌骨植入体能获得较佳的性能：纳米孔腔具有很大的比表面积，能承载很多的生长因子等药物，并有助于血液有更多的流动通道，其纳米级的联通孔会产生很大的毛细力，显著增大渗透率，达到1.5×10-9m2以上，促进血液流动，而且，纳米孔有利于细胞的粘附、分化、迁移、生长。中间一级孔腔用于细胞的寄居，最大级孔腔用于血管、组织的长入，因而，这种结构的髌骨植入体特别能满足人工髌骨植入体置换对髌骨植入体的多功能需求。
（6）当髌骨植入体的多级孔材料的最大一级孔的孔径为360μm-600μm，特别有利于骨组织长入，有利于骨组织再生。
附图说明
下面将结合附图与实施例对本发明作进一步阐述。
图1为本发明髌骨植入体结构示意主视图；
图2为图1的左视图；
图3为髌骨植入体实施例2结构示意主视图；
图4为图3的左视图；
图5为髌骨植入体实施例3结构示意主视图；
图6为图5的左视图；
图7为髌骨植入体实施例5结构示意主视图；
图8为图7的左视图。
具体实施方式
下面结合附图对本发明的具体实施方式作说明，实施方式以本发明技术方案为前提，给出了详细的实施方式和具体的操作过程，但本发明的保护范围不仅限于下述的实施方式。
如图1-2所示，1为支撑部，2为固定柱，3为支撑部与剩余髌骨的贴合面。
以下详细给出本发明的实施例：
实施例1
本实施例髌骨植入体，参见图1-2，其支撑部1上有3个固定柱2，材料采用多级孔磷酸钙，具有两级孔结构，均匀分布的大孔腔平均孔径为360µm，在大孔腔的腔壁上有均匀分布的小孔腔，平均孔径为350nm，大孔腔、小孔腔各自互相贯通且大孔腔与小孔腔之间也相互贯通，总孔隙率为61%，渗透率为0.51×10-9m2。该髌骨植入体制备方法是：
（1）将平均粒径50nm的磷酸钙粉、平均粒径430nm的淀粉、平均粒径450µm的甲基纤维素按照体积比25：6：77均匀混合。
（2）参照CT影像设计髌骨植入体的形状尺寸，然后设计制造髌骨植入体模具。
（3）将（1）中制备的混合粉末均匀填满（2）中的髌骨植入体模具并压实，放入真空炉烧结，再按照磷酸钙常规工艺进行后续处理，即得到具有二级孔结构的磷酸钙髌骨植入体。
实施例2
本实施例髌骨植入体，参见图3-4，其支撑部上有2个固定柱，材料采用多级孔铌，具有两级孔结构，均匀分布的大孔腔平均孔径为500µm，在大孔腔的腔壁上有均匀分布的小孔腔，平均孔径为410nm，大孔腔、小孔腔各自互相贯通且大孔腔与小孔腔之间也相互贯通，总孔隙率为75%，渗透率为0.56×10-9m2。该髌骨植入体2个固定柱与所述贴合面接触面的中心的连线穿过所述贴合面重心c并位于所述贴合面长轴方向b-b，所述2个固定柱与所述贴合面接触面的中心的距离a为贴合面最大几何尺寸s的55% ，制备方法与实施例1相似。
实施例3
本实施例髌骨植入体，参见图5-6，其支撑部上有3个固定柱，材料采用多级孔钛，具有两级孔结构，均匀分布的大孔腔平均孔径为600µm，在大孔腔的腔壁上有均匀分布的小孔腔，平均孔径为450nm，大孔腔、小孔腔各自互相贯通且大孔腔与小孔腔之间也相互贯通，总孔隙率为85%，渗透率为0.59×10-9m2，3个所述固定柱之间呈三角状排布， 3个固定柱与所述贴合面接触面的中心的连线形成的由阴影表示的三角形的面积为贴合面面积的15%，制备方法与实施例1相似。
实施例4
本实施例与实施例3基本相同，不同之处在于3个固定柱与所述贴合面接触面的中心的连线形成的三角形为等边三角形。
实施例5
本实施例髌骨植入体，参见图7-8，其支撑部上有3个固定柱，材料采用多级孔钽，具有三级孔结构，其中，均匀分布、相互贯通的第一级孔腔（即最大级孔腔）的腔壁上有均匀分布、相互贯通的第二级孔腔，第二级孔腔的腔壁上有均匀分布、相互贯通的第三级孔腔（即最小级孔腔）；且各级孔腔相互间也彼此贯通。其第三级孔腔平均孔径为230nm，第二级孔腔平均孔径为90µm，第一级孔腔平均孔径为600µm。总孔隙率为90%，渗透率为1.52×10- 9m2。该髌骨植入体固定柱侧面与支撑部贴合面为圆角过渡，圆角半径为r，其值为图中阴影部分显示的垂直于固定柱长轴的横截面面积值平方根的0.45倍，该髌骨植入体制备方法是：
（1）采用平均粒径为40nm的钽粉为原料，平均粒径为300nm 的淀粉做为待制多级孔钽的最小一级孔腔的造孔剂，用平均粒径为300nm的硬脂酸作为粘合剂，按照钽粉：淀粉：硬脂酸：蒸馏水按体积比1：4：1：12配制成浆料。
采用孔径为500µm-800µm的聚酯泡沫，将所述浆料用泡沫浸渍法均匀填充其中，形成坯体并干燥，然后破碎得到颗粒为40µm-60µm的含有原料、造孔剂与聚酯泡沫的混合颗粒。
（2）参照CT影像设计髌骨植入体的形状尺寸，按照髌骨植入体的形状及尺寸制备三维贯通的聚酯泡沫体及模具，聚酯泡沫体棱平均直径为710µm、平均孔径为700µm，将混合颗粒、平均粒径为100µm的氯化铵按体积比1：4充分均匀混合后均匀地灌入上述聚酯泡沫体中，然后将聚酯泡沫体放入模具真空烧结。
（3）烧结后的坯体按照钽材工艺进行常规后续热处理得到具有三级孔的多级孔钽髌骨植入体。

Claims (8)

1.一种髌骨植入体，包括用于与髌骨切骨后的剩余髌骨相匹配的主体部，所述主体部具有支撑部、设置在所述支撑部与剩余髌骨的贴合面上用于插入所述剩余髌骨的孔位中的固定柱，所述固定柱不少于2个，所述支撑部和所述固定柱均由多孔材料构成，其特征在于：所述多孔材料为多级孔材料，它由以材料孔径大小进行分级的各级孔腔，及围绕形成孔腔的各级腔壁构成，每级孔腔均各自相互贯通且各级孔腔相互间也彼此贯通，所述的多级孔材料按照材料孔径大小分为三级，最小级孔腔孔径为纳米级，最大级孔腔孔径为微米级，中间一级孔腔孔径介于最小级孔腔孔径与最大级孔腔孔径之间，所述的多级孔材料的最大一级孔的孔径为360μm-600μm，所述多级孔材料渗透率大于0.5×10-9 m2。
2.如权利要求1所述的髌骨植入体，其特征在于：固定柱为2个，2个固定柱与所述贴合面接触面的中心的连线穿过所述贴合面重心并位于所述贴合面长轴方向，所述2个固定柱与所述贴合面接触面的中心的距离不小于贴合面最大几何尺寸的50%。
3.如权利要求1所述的髌骨植入体，其特征在于：所述固定柱有3个，3个固定柱之间呈三角状排布，3个固定柱与所述贴合面接触面的中心的连线形成的三角形的面积不小于所述贴合面面积的12%。
4.如权利要求3所述的髌骨植入体，其特征在于：所述3个固定柱与所述贴合面接触面的中心的连线形成的三角形为等边三角形。
5.如权利要求1至4任一权利要求所述的髌骨植入体，其特征在于：所述固定柱侧面与所述贴合面为圆角过渡，圆角半径值不小于垂直于固定柱长轴的横截面面积值平方根的0.4倍。
6.如权利要求1至4任一权利要求所述的髌骨植入体，其特征在于：所述的多级孔材料的总孔隙率为61%-90%。
7.如权利要求1至4任一权利要求所述的髌骨植入体，其特征在于：所述多级孔材料渗透率大于1.5×10-9 m2。
8.如权利要求1至4任一权利要求所述的髌骨植入体，其特征在于：所述的多级孔材料用医用钽及合金、医用钛及合金、医用铌及合金、医用钴基合金、医用不锈钢、羰基磷灰石、磷酸钙、磷酸三钙、生物活性玻璃、氧化铝或者氧化锆制备。
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