CN107349031B - 一种多孔金属棒 - Google Patents
一种多孔金属棒 Download PDFInfo
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Abstract
一种多孔金属棒,由多孔金属材料制备,该多孔金属棒包括两部分,一部分为圆棒状部分,与其相连的另一部分为螺纹部分,其外部具有螺纹,螺纹外径大于圆棒状外径,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。该多孔金属棒有利于组织长满植入体内部,实现植入体与股骨的紧密融合,使界面稳固,避免了松动,避免了病人痛苦,延缓了人工髋关节置换的时间。
Description
技术领域
本发明涉及假体领域,具体涉及一种用于治疗早期股骨头坏死的医用植入的多孔金属棒。
背景技术
股骨头坏死是一种慢性进行性疾病,是由于多种原因导致的股骨头缺血、坏死、骨小梁断裂、股骨头塌陷,临床以髋关节疼痛、功能障碍为主要表现,致残率高。全世界现有股骨头坏死患者2000多万例,其中我国有500-750万例。
成人股骨头坏死的治疗方法很多,各有优缺点,当病情发展到关节毁损阶段时,需行人工髋关节置换。然而,人工髋关节置换存在感染、松动、脱位、磨损等诸多缺点,特别是年轻患者,由于人工关节的使用寿命限制,需要多次置换,假体的植入,骨量的大量丢失,会使翻修越来越困难。股骨头坏死的治疗效果与病情轻重、发现早晚、病程分期有很大关系,病变发现越早,病情越轻,治疗效果就越好,因此股骨头坏死应做到早期诊断和早期治疗,以缓解病人症状、促进骨组织修复、延缓人工髋关节置换的时间。近年来,多孔金属棒如多孔钽金属棒是治疗早期股骨头坏死的一种新方法,它具有减压、结构性支撑、微创的特点,且不存在取骨部位并发症,既有助于恢复股骨头颈的力学性能,又有利于达到股骨头颈部的植骨融合的目的。目前已有国外的多孔金属棒在国内临床应用。
发明专利CN 103462730 B 一种多孔钽棒及其应用介绍了一种多孔钽棒,用于治疗早、中期股骨头坏死。该多孔钽棒包括本体,本体由化学气相沉积方法制备的多孔钽制成,本体的一端设置有凹槽,可负载骨髓基质干细胞或骨髓基质干细胞联合生物膜复合体等,有利于新生骨的生成,另一端为螺纹结构,所述螺纹结构末端端面上设置有槽口。然而,该多孔钽棒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,多孔钽棒植入后,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,不利于植入体与股骨的融合,而且致密材料的腔壁承载的生长因子等药物有限,因而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,影响了治疗效果。
发明内容:
本发明的目的是提供一种有利于骨组织再生、治疗效果更好的用于治疗早期股骨头坏死的医用植入的多孔金属棒。
发明人认为,如果在单一空隙的多孔材料的孔的腔壁上再设置空隙,就可以降低腔壁的弹性模量,并能使腔壁承载更多的药物,因此,本发明提出了如下技术方案:
一种多孔金属棒,由多孔金属材料制备,该多孔金属棒包括两部分,一部分为圆棒状部分,与其相连的另一部分为螺纹部分,其外部具有螺纹,螺纹部分末端端面上设置有槽口,螺纹外径大于圆棒状外径,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,所述的多孔金属棒,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孔径与第三级孔腔孔径之间,该种结构特别有利于多孔金属棒植入后的骨组织再生。
进一步说,所述的多孔金属棒,所述多级孔金属材料中最小级多孔金属材料的孔径为1µm以下,最小级多孔金属材料的弹性模量为76GPa以下,孔隙率不小于43%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,所述的多孔金属棒,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52GPa,孔隙率不小于50%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,所述的多孔金属棒,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14GPa,孔隙率不小于60%为佳,该弹性模量值及孔隙率值结合下两级孔的存在更有利于骨组织再生。
进一步说,所述的多孔金属棒,所述多级孔金属材料整体弹性模量为2-5GPa,与人体骨弹性模量接近,有利于多孔金属棒得到应力刺激。
进一步说,所述的多孔金属棒,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,从而使得多孔金属棒性能均匀、一致。
进一步说,所述的多孔金属棒,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)本发明提供的多孔金属棒,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,而且腔壁上有孔隙显著增加了腔壁的比表面积,其承载的生长因子等药物显著增加,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,促进骨组织修复,实现植入体与相邻骨组织的紧密融合,使多孔金属棒牢固地固定在股骨中,克服了界面不稳、松动问题,避免了病人痛苦,延缓了人工髋关节置换的时间。
(2)本发明提供的多孔金属棒,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多孔金属棒植入后的骨组织再生,第一级孔腔尺寸有利于组织长入,第二级孔腔有利于多种细胞的寄居,第三级孔腔特别有利于细胞的的黏附、分化、迁移。
(3)本发明提供的多孔金属棒,所用多级孔结构的多孔金属材料各级孔孔隙率与弹性模量更有利于使多孔金属棒的整体弹性模量真正地与人体骨整体弹性模量相当,有利于多孔金属棒上的细胞得到应力刺激,促进骨组织再生。
(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,从而使得多孔金属棒性能均匀、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为本发明多孔金属棒示意图,图2为图1左视图。图3显示了用于制备多孔金属棒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、图2所示,1为圆棒状部分,2为螺纹部分,3为螺纹部分末端端面上的槽口。图3显示多级孔金属材料为二级孔材料,大孔4为第一级孔腔,5为大孔4的腔壁,大孔4腔壁5上的小孔6为第二级孔腔。
实施例1
一种多孔金属棒,由多孔金属材料制备,该多孔金属棒包括两部分,一部分为圆棒状部分1,与其相连的另一部分为螺纹部分2,其外部具有螺纹,螺纹部分2末端端面上设置有槽口3,螺纹外径大于圆棒状外径,所述的多孔金属材料为多级孔金属材料,该多级孔金属材料分为两级,第一级孔腔4为大孔,孔径为150µm-450µm,呈三维空间围绕构成第一级孔腔4的腔壁5由第二级多孔金属材料构成,第二级多孔金属材料的孔腔6孔径为370nm-600nm,每级孔腔均各自相互贯通且各级孔腔相互间也彼此贯通,材料为不锈钢316L,其制备方法是:
(1)多孔不锈钢材料坯体制备
a.材料准备
采用粒径为100nm-150nm的不锈钢316L粉为原料,粒径为450nm-700nm的甲基纤维素做为最小级孔造孔剂,用粒径为450nm-700nm的聚苯乙烯作为粘合剂,按照不锈钢粉:甲基纤维素:聚苯乙烯:蒸馏水按体积比1:1.5:1:8配制成浆料。
采用棱直径为250µm-550µm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250µm-550µm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;烧结后的坯体按照不锈钢316L的常规工艺进行后续处理得到级数为二级的多孔不锈钢316L材料坯体。
(2)对多孔不锈钢316L材料坯体进行机加工,加工出多孔金属棒。
所制备的多孔金属棒的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。
用常规泡沫浸渍法制备仅具有第一级孔腔4的多孔不锈钢,其孔的分布与原具有二级孔的多孔不锈钢相同,孔隙率为72%,该孔隙率是指材料仅有第一级孔腔的孔隙率,即计算时不计第二级孔腔(将第二级孔腔视为致密实体),采用WE-100B力学试验机测试上述多孔不锈钢试样压缩应力-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7.3GPa。
用纳米压痕法测量第二级多孔不锈钢材料的弹性模量,测得具有第二级孔腔6的多孔不锈钢的弹性模量为60GPa,第二级多孔不锈钢材料孔隙率为50%,该孔隙率计算时仅取第二级多孔金属材料,按照第二级孔腔的体积与所取的材料体积计算孔隙率。
采用WE-100B力学试验机测试该具有二级孔结构的多孔不锈钢材料整体弹性模量为5GPa。
实施例2:
本实施例与实施例1相似,不同之处为多孔金属棒所用材料为纯钛,第一级孔腔4孔径为850µm-1400µm,孔隙率为78%,弹性模量为2.9GPa,第二级孔腔6孔径为450nm-750nm,孔隙率为45%,弹性模量为72GPa,多孔金属整体弹性模量为2GPa。
实施例3:
一种多孔金属棒,采用钽金属制备的多级孔金属材料,具有三级孔结构,第一级孔腔孔径为380µm-500µm,第二级孔腔孔径为35µm-65µm,第三级孔腔孔径为300nm-450nm,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,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,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45µm-75µm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460µm-580µm、孔径为600µm-830µm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孔级数为三级的多孔钽坯体,然后机加工出多孔金属棒。
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80%,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56%,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70%,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36GPa,具有第三级孔腔的多孔钽的弹性模量为65GPa。
用常规泡沫浸渍法制备仅具有第一级孔腔的多孔钽,采用WE-100B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3.9GPa。
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2.8GPa。
Claims (10)
1.一种多孔金属棒,由多孔金属材料制备,该多孔金属棒包括两部分,一部分为圆棒状部分,与其相连的另一部分为螺纹部分,其外部具有螺纹,螺纹部分末端端面上设置有槽口,螺纹外径大于圆棒状外径,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;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。
2.如权利要求1所述的多孔金属棒,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孔径与第三级孔腔孔径之间。
3.如权利要求1所述的多孔金属棒,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孔径为1µm以下,最小级多孔金属材料的弹性模量为76GPa以下,孔隙率不小于43%。
4.如权利要求2所述的多孔金属棒,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76GPa以下,孔隙率不小于43%。
5.如权利要求1至4任一权利要求所述的多孔金属棒,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52GPa,孔隙率不小于50%。
6.如权利要求1至4任一权利要求所述的多孔金属棒,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14GPa,孔隙率不小于60%。
7.如权利要求5所述的多孔金属棒,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14GPa,孔隙率不小于60%。
8.如权利要求1至4中任一权利要求所述的多孔金属棒,其特征在于:所述多级孔金属材料整体弹性模量为2-5GPa。
9.如权利要求1至4任一权利要求所述的多孔金属棒,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、医用不锈钢或医用钴基合金制备。
10.如权利要求8所述的多孔金属棒,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、医用不锈钢或医用钴基合金制备。
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