CN107198597A - 一种胫骨托植入体 - Google Patents
一种胫骨托植入体 Download PDFInfo
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Abstract
一种胫骨托植入体,包括胫骨托板、胫骨茎、胫骨茎支撑,它由多孔金属材料制成,该多孔金属材料为多级孔金属材料,其本体是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;呈三维空间围绕构成上级孔腔的腔壁由下级多孔金属材料构成,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;该胫骨植入体有利于组织长满植入体内部,实现植入体与胫骨的紧密融合,使界面稳固,避免了松动。
Description
技术领域
本发明涉及一种医用植入体,特别是胫骨托植入体。
背景技术
如今患慢性膝关节疾病的中老年人群中主要患的是骨性关节炎和类风湿性关节炎,到目前为止,全膝置换手术(TKA)将发生病变且无法进行自我修复的股骨关节面软骨、胫骨关节面软骨、半月板等软骨组织全部去除,然后换上与此膝关节解剖结构和几何尺寸相近的人工膝关节,己经成为其比较有效的治疗方式。随着全球人口老龄化的加剧,全膝置换的需求越来越大。美国仅2011年的膝关节置换量就达68万,比1999年增长了159%,2010和2011年还分别以3.7%和4.4%的增长率在增长。中国2009年进行了3.7万例TKA,2011年是6.1万例,2年增长了62.3%,2010和2011年还分别在以27. 9%和26. 9%的增长率在增长。因此人工膝关节植入体需求巨大。
人工膝关节一般由三个部件组成:股骨髁植入体、半月板植入体、胫骨托植入体。半月板植入体位于股骨髁植入体和胫骨托植入体中间,可以在股骨和胫骨托植入体之间传导负荷。
人体膝关节负重时受力大且应力状态复杂:它同时承受拉力、压力、扭转和界面剪切及反复疲劳、磨损等力的作用,因此要求植入体必须与骨之间牢牢固定。传统的人工膝关节主体和表面均为无孔致密的结构,通常采用增大表面粗糙度以提高与骨骼之间结合。应用结果表明,该种结合不稳固,部分患者出现无菌性松动并发症,影响了使用寿命。
为提高植入体与骨结合的稳固性,研究人员采用了多孔材料制造人工膝关节部件,如CN201280071940.9“用于膝关节假体的不对称胫骨件”介绍的人体膝关节部件胫骨托用多孔生物材料制备,如多孔钽、多孔铌,该多孔材料使骨向内增长使胫骨托在骨上固定。然而,该胫骨托植入体所用的多孔材料为单一空隙的材料,其孔的腔壁仍为致密材料,胫骨托植入体植入后,在受力时,尽管材料整体弹性模量较低,但作为腔壁的致密材料由于弹性模量较大,使得多孔材料的孔的腔壁上的细胞难以感受到力的刺激作用,出现应力屏蔽,不利于细胞生长,不利于植入体与胫骨的融合,不利于实现骨组织再生;进一步研究发现,用单一空隙的化学气相沉积制备的多孔钽作为骨植入体,骨组织长入植入体的深度不足3mm,从而使得植入体与相邻骨组织的界面不牢固,会出现松动。
发明内容:
本发明的目的是提供一种与周围骨组织结合界面稳固、牢靠的胫骨托植入体。
本发明目的通过如下技术方案实现:
一种胫骨托植入体,包括胫骨托板、胫骨茎、胫骨茎支撑,它由多孔金属材料制成,所述的多孔金属材料为多级孔金属材料,所述多级孔金属材料本体是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;呈三维空间围绕构成上级孔腔的腔壁由下级多孔金属材料构成,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。
进一步说,所述的胫骨托植入体,所述多级孔金属材料分级级数为三级时,第一级孔腔的孔径为微米级孔,第三级孔腔孔径为纳米级孔,第二级孔腔的孔径介于第一级孔腔与第三级孔腔的孔径之间,该种结构特别有利于胫骨托植入体植入后的骨组织再生。
进一步说,所述的胫骨托植入体,所述多级孔金属材料中最小级多孔金属材料的孔径为1微米以下,最小级多孔金属材料的弹性模量为80GPa以下,孔隙率不小于40%为佳,该孔隙率是指材料仅有该级孔腔的孔隙率,最小级孔在上一级孔的腔壁上,从而使得上一级孔的腔壁的弹性模量小于致密金属材料的弹性模量。
进一步说,所述的胫骨托植入体,多级孔金属材料中,比最小级孔腔大一级的上级多孔金属材料的弹性模量小于50GPa,孔隙率不小于55%为佳,该上级多孔金属材料的腔壁上最小级孔腔的存在使得腔壁的弹性模量小于致密金属材料的弹性模量,另外,该多级孔金属材料的整体弹性模量相对于只有单一上极孔材料的弹性模量也进一步降低。
进一步说,所述的胫骨托植入体,所述多级孔金属材料中,比最小级孔腔大二级的上级多孔金属材料的弹性模量小于12GPa,孔隙率不小于70%为佳,该弹性模量值及孔隙率值结合下两级孔的存在有利于骨组织再生。
进一步说,所述的胫骨托植入体,所述多级孔金属材料整体弹性模量为1.5-5GPa,与人体骨弹性模量接近,有利于胫骨托植入体得到应力刺激。
进一步说,所述的胫骨托植入体,所述多级孔金属材料中的每一级的同级多孔金属材料的孔腔在所述材料本体内是均匀分布的,从而使得胫骨托植入体性能均匀、一致。
进一步说,所述的胫骨托植入体,所述多级孔金属材料由医用钛及合金、医用铌及合金、医用钽及合金、医用不锈钢、医用钴基合金制备。
本发明的有益效果:
(1)本发明提供的胫骨托植入体,采用了多级孔结构的多孔金属材料,材料本体是由以材料孔径大小进行分级的孔腔,及围绕形成孔腔的腔壁构成,呈三维空间围绕构成上级多孔金属材料的孔腔的腔壁由下级多孔金属材料构成,每级多孔金属材料的孔腔均各自相互贯通且各级多孔材料的孔腔相互间也彼此贯通。由于上级孔腔的腔壁上有下级孔,使得该孔腔的弹性模量相对致密材料显著降低,从而使孔内粘附在腔壁上的细胞能感受到应力的刺激,避免应力屏蔽,促进细胞快速生长,实现再生,由于贯通性很好,加之腔壁上孔具有毛细作用,使组织液、新陈代谢物能快速、充分传输,组织顺利生长,特别是有利于骨组织长入植入体内部,实现植入体与相邻骨组织的紧密融合,使胫骨托植入体牢固地固定在胫骨上,克服了界面不稳、松动问题,避免了关节返修,减轻了病人痛苦,延长了人工膝关节寿命。
(2)本发明提供的胫骨托植入体,所用多级孔结构的多孔金属材料采用的三级孔结构特别有利于胫骨托植入体植入后的骨组织再生,第一级孔腔尺寸有益于满足组织长入的需求,第二级孔腔有益于多种细胞的寄居,第三级孔腔有益于满足细胞的的黏附、分化需求。
(3)本发明提供的胫骨托植入体,所用多级孔结构的多孔金属材料最小级孔、最小级孔上一级孔及上二级孔材料的弹性模量、孔隙率数值的设定有助于使孔腔腔壁的弹性模量相对于致密金属材料显著降低,有助于使孔内粘附在腔壁上的细胞能感受到应力的刺激,且整体弹性模量与动物松质骨整体弹性模量相当,有利于胫骨托植入体上的细胞得到应力刺激。
(4)多级孔金属材料中的每一级的同级多孔金属材料的孔腔在所述材料本体内是均匀分布的,从而使得胫骨托植入体性能均匀、一致。
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为本发明胫骨托植入体示意图,1-1为主视图,1-2左视图,1-3为俯视图。
图2显示了用于制备胫骨托植入体的多级孔金属材料结构。
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所示,1为胫骨托板,2为胫骨茎,3为胫骨茎支撑。图2显示多级孔金属材料为二级孔材料,4为大孔,5为大孔的腔壁,6为大孔腔壁上的小孔。
实施例1
一种胫骨托植入体,采用二级孔结构的多孔铌材料制备,第一级孔腔孔径为350µm-550µm,第二级孔腔孔径为300nm-600nm。其制备方法是:
(1)多孔铌材料坯体制备
a.材料准备
采用粒径为100nm-150nm的铌粉为原料,粒径为400nm-700nm的甲基纤维素做为最小级孔造孔剂,用粒径为400nm-700nm的聚苯乙烯作为粘合剂,按照铌粉:甲基纤维素:聚苯乙烯:蒸馏水按体积比1:1.5:1:7配制成浆料。
采用棱直径为430µm-640µm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430µm-640µm的含有原料、造孔剂与聚酯泡沫的混合颗粒。
b.将混合颗粒放入密闭模具压制成致密坯体。
c.将致密坯体真空烧结;烧结后的坯体按照铌的常规工艺进行后续处理得到级数为二级的多孔铌材料坯体。
(2)对多孔铌材料坯体进行机加工,加工出胫骨托植入体。
用常规泡沫浸渍法制备仅具有第一级孔腔的多孔铌,其孔的分布与原具有二级孔的多孔铌相同,孔隙率为76%,采用Instron力学试验机测试上述多孔铌试样压缩应力-应变曲线,其应力-应变曲线显示的初始变形为弹性变形,取弹性变形部分应力值与相应应变值之比即为弹性模量,测得弹性模量为6.5GPa。
用纳米压痕法测量第二级多孔铌材料的弹性模量,测得具有第二级孔腔的多孔铌的弹性模量为79GPa,第二级多孔铌材料孔隙率为41%。
采用Instron力学试验机测试该具有二级孔结构的多孔铌材料整体弹性模量为4.5GPa。
实施例2:
一种胫骨托植入体,采用二级孔结构的多孔钴基合金材料CoNiCrMo制备,第一级孔腔孔径为200µm-400µm,第二级孔腔孔径为400nm-650nm。其制备方法与实施例1相似。
该种多孔钴基合金第一级孔孔隙率为73%,弹性模量为8GPa,第二级孔孔隙率为56%,弹性模量为48GPa,整体弹性模量为5GPa。
实施例3:
一种胫骨托植入体,采用三级孔结构的多孔钽材料,第一级孔腔孔径为450µm-600µm,第二级孔腔孔径为45µm-75µm,孔隙率为73%,第三级孔腔孔径为350nm-520nm,孔隙率为62%。其制备方法与实施例1相似,不同是在多孔钽材料制备中,将破碎得到的混合颗粒、粒径为53µm-85µm的乙基纤维素按体积比1:3均匀混合后均匀地灌入棱直径为530µm-700µm、孔径为680µm-890µm的三维贯通的聚酯泡沫中,然后将聚酯泡沫放入密闭模具压制成致密坯体。将致密坯体真空烧结;烧结后的坯体按照钽材工艺进行常规后续热处理得到级数为三级的多孔钽坯体,然后机加工出胫骨托植入体。
用断面直接观察法测试材料孔隙率,结果为:第一级孔孔隙率为87%,该孔隙率是指材料仅有第一级孔腔的孔隙率,即计算时不计第二、第三级孔腔(将第二、第三级孔腔视为致密实体)。第三级孔腔孔隙率为65%,该孔隙率是指材料仅有第三级孔腔的孔隙率,即计算时,取仅有第三级孔腔的材料部分进行分析计算,第二级孔孔隙率为73%,该孔隙率是指材料仅有第二级孔腔的孔隙率,即计算时,取仅有第二级、第三级孔腔的材料部分进行计算,但不计第三级孔腔,将其作为致密实体。
用纳米压痕法测量第二级多孔材料、第三级多孔材料的弹性模量,测得具有第二级孔腔的多孔钽的弹性模量为30GPa,具有第三级孔腔的多孔钽的弹性模量为55GPa。
用常规泡沫浸渍法制备仅具有第一级孔腔的多孔钽,采用Instron力学试验机测试上述多孔钽试样压缩应力-应变曲线,其应力-应变曲线显示的初始变形为弹性变形,取弹性变形部分应力值与相应应变值之比即为弹性模量,测得弹性模量为2.4GPa。
用上述同样测试方法,测得该具有三级孔腔结构的多孔钽整体弹性模量为1.5GPa。
发明人用上述发明的几种胫骨托植入体对家犬胫骨进行了植入试验,结果表明,植入13周后,组织完全长满植入体内部,该种胫骨托植入体与胫骨组织紧密融合,界面稳固,没有出现松动现象。
Claims (10)
1.一种胫骨托植入体,包括胫骨托板、胫骨茎、胫骨茎支撑,它由多孔金属材料制成,其特征在于,所述的多孔金属材料为多级孔金属材料,所述多级孔金属材料本体是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;呈三维空间围绕构成上级孔腔的腔壁由下级多孔金属材料构成,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。
2.如权利要求1所述的胫骨托植入体,其特征在于:所述多级孔金属材料分级级数为三级时,第一级孔腔的孔径为微米级孔,第三级孔腔孔径为纳米级孔,第二级孔腔的孔径介于第一级孔腔与第三级孔腔的孔径之间。
3.如权利要求1所述的胫骨托植入体,其特征在于:多级孔金属材料中最小级多孔金属材料的孔径为1微米以下,最小级多孔金属材料的弹性模量为80GPa以下,孔隙率不小于40%。
4.如权利要求2所述的胫骨托植入体,其特征在于:所述多级孔金属材料中最小级多孔金属材料的弹性模量为80GPa以下,孔隙率不小于40%。
5.如权利要求1至4任一权利要求所述的胫骨托植入体,其特征在于:所述多级孔金属材料中,比最小级孔腔大一级的上级多孔金属材料的弹性模量小于50GPa,孔隙率不小于55%。
6.如权利要求1至4任一权利要求所述的胫骨托植入体,其特征在于:所述多级孔金属材料中,比最小级孔腔大二级的上级多孔金属材料的弹性模量小于12GPa,孔隙率不小于70%。
7.如权利要求5所述的胫骨托植入体,其特征在于:所述多级孔金属材料中,比最小级孔腔大二级的上级多孔金属材料的弹性模量小于12GPa,孔隙率不小于70%。
8.如权利要求1至7任一权利要求所述的胫骨托植入体,其特征在于:所述多级孔金属材料整体弹性模量为1.5-5GPa。
9.如权利要求1至8任一权利要求所述的胫骨托植入体,其特征在于:所述多级孔金属材料中的每一级的同级多孔金属材料的孔腔在所述材料本体内是均匀分布的。
10.如权利要求1至9任一权利要求所述的胫骨托植入体,其特征在于:所述多级孔金属材料由医用钛及合金、医用铌及合金、医用钽及合金、医用不锈钢、医用钴基合金制备。
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CN105233347A (zh) * | 2015-10-30 | 2016-01-13 | 吉林大学 | 一种3d打印梯度孔径医用多孔金属骨组织支架 |
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CN105233347A (zh) * | 2015-10-30 | 2016-01-13 | 吉林大学 | 一种3d打印梯度孔径医用多孔金属骨组织支架 |
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