CN104667342B - 椎间植入物 - Google Patents
椎间植入物 Download PDFInfo
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- CN104667342B CN104667342B CN201410527785.8A CN201410527785A CN104667342B CN 104667342 B CN104667342 B CN 104667342B CN 201410527785 A CN201410527785 A CN 201410527785A CN 104667342 B CN104667342 B CN 104667342B
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Abstract
一种椎间植入物,其由多个金属球体所组成的一多孔结构,且椎间植入物包括骨支撑区及骨成长区;其中,骨支撑区及骨成长区各具有多个个连通孔,且骨支撑区的孔隙率小于骨成长区的孔隙率。本发明提供的椎间植入物,其由多个均一粒径的金属球体所组成,且具有多个区域,各区依金属球体所组成的数量不同,具有相异的孔隙率及孔隙大小,藉此提供具有多重刚性复合孔隙结构的椎间植入物,且各区孔隙分布平均,其所产生应力也平均,使椎间植入物可承受的应力效果更佳。
Description
技术领域
本发明涉及一种椎间植入物,特别涉及一种由多个均一粒径的金属球体所组成的椎间植入物,且椎间植入物具有多个区域,其中各区依金属球体所组成的数量不同,分别形成相异的孔隙率及孔隙大小,使椎间植入物为具有多重刚性的复合孔隙结构。
背景技术
腰椎椎间融合术,意指从两节脊椎中取出椎间盘,然后把二者融合起来。这个步骤又名为「脊柱融合术」。通常用于治疗由脊椎退化、椎间盘突出等脊柱病而引致的持续背痛、坐骨神经痛或双腿酸软无力等病患。
现存椎间融合植体于植入骨后有融合效果不佳并且造成滑脱的问题,因此临床常利用人工骨、生长因子与药物等辅助治疗方法,促进脊椎骨质与植体的融合度,但是利用额外添加方式其释放期程短且具有局部区域浓度不均匀等问题,因此在植体上设置多孔结构,用以使骨生长于孔隙中提高植体于骨的融合度。
现有技术中,如中国专利号202086620所揭示的一种具有生物活性多孔钛合金人颈椎间融合器。该生物活性多孔钛合金人颈椎间融合器的外周部具有规则孔隙,平均孔径300至400μm,孔隙率40%至50%;但中央部具有骨小梁样不规则孔隙,平均孔径400至1000μm,孔隙率60%至80%,且在外周部及中央部的孔隙中附着有rhBMP-2或明胶微球,多孔结构及其内部生物活性因数缓释系统能诱导新生骨组织长入,解决了骨与材料介面结合问题,具有比致密材料更好的力学相容性与骨整合能力,但中央部具有骨小梁样不规则孔隙,此结构成形难,目前金属粉体激光烧结成形设备仍无法达成内部不规则与外部规则接合,且孔隙大小不平均,其结构容易产生不同应力。
现有技艺中,如中国专利号CN101279106所揭示的一种多孔钛钴合金医用植入物的凝胶注模制备方法。属于医用材料制备技术领域。将单体丙烯酰胺、交联剂亚甲基双丙烯酰胺与去离子水配制成一定浓度的预混液,加入分散剂油酸使钛钴粉末悬浮于预混液中制成浆体,调节pH值至9.0~10.0,然后加入适量催化剂N-四甲基乙二胺和引发剂过硫酸铵搅拌均匀,经排气后注入模具中,模内的单体发生聚合反应形成网状结构将钛钴粉体包裹,成为由大分子网络定型的坯体。坯体经干燥、排胶、烧结得到产品,此外还可以通过调节固含量来改变多孔钛钴合金的孔隙率和力学性能。
现有技术中,如美国专利号US8361150 Composite implant所揭示一种可用于椎间融合治疗的综合结构的腰椎植入物。包含上下层多孔状金属结构,中间夹合一层高分子结构。其中上下两层多孔结构物让骨细胞攀附后往内孔生长,中间层高分子结构物具备黏合上下两层多孔结构功能与支撑整体植入物功能。整体综合结构植入物具备使上下两节椎体融合的功能,此技术价格较高昂,因上下层为单一孔细隙率多孔结构,稳定度较低。
发明内容
本发明的目的在于提供一种椎间植入物,其由多个均一粒径的金属球体所组成,且具有多个区域,各区依金属球体所组成的数量不同,具有相异的孔隙率及孔隙大小,藉此提供具有多重刚性复合孔隙结构的椎间植入物,且各区孔隙分布平均,其所产生应力也平均,使椎间植入物可承受的应力效果更佳。
本发明利用造孔剂混合多个均一粒径的金属粉粒,接着经由烧结得到的椎间植入物,因此可直接通过调整造孔剂混合于金属粉粒的重量百分比,控制椎间植入物的孔隙率及孔隙大小,达成所需的力学性能。进一步地,本发明利用具有骨支撑形成区及骨成长形成区的制具,分别填充具有相异重量百分比的造孔剂混合于金属粉粒的混料,藉此形成具有骨支撑区及骨成长区的椎间植入物,且骨支撑区及骨成长区具有相异孔隙率及孔隙大小,使椎间植入物不需要高分子材料也可以达到多重刚性功能。
本发明椎间植入物,其是由多个金属球体所组成的多孔结构,且椎间植入物包括骨支撑区及骨成长区;其中,骨支撑区及骨成长区各具有多个连通孔,且骨支撑区的孔隙率小于骨成长区的孔隙率。
如上述,在一实施例中,多孔结构是由多个金属粉粒混合一造孔剂,以真空烧结成多个金属球体所组成。
如上述,在一实施例中,骨支撑区及骨生长区所含多个金属球体各具有均一粒径。
如上述,在一实施例中,其中当多个金属粉粒混合造孔剂时,造孔剂的重量百分比介于1wt%至70wt%之间。
如上述,在一实施例中,多个金属球体的粒径介于10um至100um之间。
如上述,在一实施例中,其中多个连通孔的孔径大小各介于50um至500um之间。
如上述,在一实施例中,其中骨支撑区及骨生长区的孔隙率各介于10%至90%之间。
如上述,在一实施例中,其中骨支撑区及骨成长区的弹性膜数介于0.17GPa至30GPa之间。
如上述,在一实施例中,多孔结构的孔洞分别均匀分布。
为了达到上述目的,本发明提供一种椎间植入物的制造方法,包括:提供一制具,制具区分有骨支撑形成区及骨成长形成区;接着以金属粉粒混合造孔剂,形成第一混料及第二混料,其中第一混料的造孔剂含量小于第二混料的造孔剂含量;接着填充第一混料于骨支撑区,且填充第二混料于骨生长区,最后以真空烧结,形成具有骨支撑区及骨成长区的椎间植入物,且骨支撑区的孔隙率是小于骨成长区的孔隙率。
本发明椎间植入物是由多个均一粒径的金属球体所组成,且具有多个区域,各区因分别填充具有相异重量百分比的造孔剂混合于金属粉粒的混料,经真空烧结后,使各区所含的金属球体数量不同,而形成为具有相异孔隙率及孔隙大小的多孔结构,多孔结构使骨生长于孔隙中,提高植体于骨的融合度,且各区的孔洞分别均匀分布且孔隙尺寸平均,因此所产生的应力也平均,则具有较佳的力学相容性。
本发明椎间植入物因各层体分别具有相异的孔隙率及孔隙大小,其不需要高分子材料也可以达到多重刚性功能,也因此当椎间植入物植入腰椎椎间时,可承受由腰椎活动时所产生的各种应力,可承受的应力范围广,稳定度高。
本发明利用造孔剂混合多个金属粉粒,经由烧结得到的椎间植入物,因此可通过调整造孔剂混合于金属粉粒的重量百分比,来控制椎间植入物的孔隙率及孔隙大小,达到所需的刚性表现。
本发明椎间植入物更接近人体椎间骨格力学性能的仿生异相多孔钛合金医材,使人体活动时,椎间可承受的应力效果更佳。
以下结合附图和具体实施例对本发明进行详细描述,但不作为对本发明的限定。
附图说明
图1根据本发明的一种椎间植入物的制造方法流程图;
图2根据本发明的一种椎间植入物的制造方法的制具分解示意图;
图3A根据本发明的一种椎间植入物的制造方法的第一混料示意图;
图3B根据本发明的一种椎间植入物的制造方法的第二混料示意图;
图4A至图4C根据本发明的一种椎间植入物的制造方法的第一混料及第二混料填满于制具示意图;
图5根据本发明的一种椎间植入物的制造方法的金属胚示意图;
图6根据本发明的一种椎间植入物的立体图。
其中,附图标记
1 制具
10 骨支撑形成区
20 骨成长形成区
30 第一混料
35 第二混料
40 金属粉粒
50 造孔剂
60 第二金属胚
70 椎间植入物
71 骨支撑区
72 骨成长区
73 金属球体
74 连通孔
90 中心块
91 上盖
95 弧面
96 器械挟持部
步骤S1~步骤S3 椎间植入物的制造方法
具体实施方式
为使对本发明的目的、构造特征及其功能有进一步的了解,兹配合相关实施例及附图详细说明如下:
请参阅图1及图2,图1根据本发明的一种椎间植入物的制造方法流程图,图2根据本发明的一种椎间植入物的制造方法的制具分解示意图。
本发明一种椎间植入物,其制造方法包括下列步骤:首先,步骤S1,提供制具1,制具1区分有骨支撑形成区10、骨成长形成区20、中心块90及上盖91。
制具1是经由电脑模拟与绘图,依所需的刚性表现,设计出椎间植入物的模具。
制具1的骨成长形成区20为可自由取出的中心块90。
使用碱性液体对制具1进行表面清洁,碱性液体的PH值为9以上。
接着请参阅图3A及图3B,图3A根据本发明的一种椎间植入物的制造方法的第一混料示意图,图3B根据本发明的一种椎间植入物的制造方法的第二混料示意图,步骤S2,以金属粉粒40混合造孔剂50,形成第一混料30及第二混料35,第一混料30的造孔剂50含量小于该第二混料35的造孔剂50含量,也就是说,第一混料30的造孔剂50的重量百分比小于第二混料35的造孔剂50的重量百分比。
使第一混料30及第二混料35中的金属粉粒40于造孔剂50中为均匀分布。
如上述,在一实施例中,第一混料30及第二混料35中的金属粉粒40为均一粒径,但本发明不限于此,依所需刚性进行设计,第一混料30及第二混料35中的金属粉粒40为相异粒径。
如上述,在一实施例中,金属粉粒为钛或钛合金,且粒径介于10um至100um。
如上述,在一实施例中,造孔剂50为粉状、浓稠度高的浆状或具可塑性的固状,可使第一混料30及第二混料35经压实后定型。
接着,请参阅图4A至图4C及图5,图4A至图4C根据本发明的一种椎间植入物的制造方法的第一混料及第二混料填满于制具示意图,图5根据本发明的一种椎间植入物的制造方法的金属胚示意图。步骤S3,填充第一混料30于骨支撑形成区10,藉由上盖91及中心块90压实后,形成具有与骨支撑形成区10相对应形状的第一金属胚,如图4A所示。
接着打开上盖91,取出中心块90,此时骨生长形成区20为一腔室,且腔室为对应中心块90的形状,如图4B所示。
接着填充第二混料35于骨生长形成区20,如图4C所示,再藉由上盖91压实后形成第二金属胚60,如图5所示。
请参阅图6,图6根据本发明的一种椎间植入物的立体图,为了使图示能清晰表现,以实线代表椎间植入物外观形状,以虚线代表骨生长区72形状。
接着对第二金属胚60进行真空烧结,经真空烧结后,形成具有骨支撑区71及该骨成长区72的一椎间植入物70,且该骨支撑区71的孔隙率是小于该骨成长区72的孔隙率。
本发明藉由上述制造方法形成一种椎间植入物70,其是由多个金属球体73所组成的一多孔结构,且该椎间植入物70包括骨支撑区71及骨成长区72;其中,骨支撑区71及骨成长区72各具有多个连通孔74,且如上述步骤S2所述,因第一混料30的造孔剂50含量小于第二混料35的造孔剂50含量,所以当第二金属胚60烧结后,骨支撑区71的孔隙率是小于骨成长区72的孔隙率。
如上述,在一实施例中,多孔结构是由多个金属粉粒40混合一造孔剂50,以真空烧结成该多个金属球体73所组成,所以金属球体73与金属粉粒40的粒径大抵相同,且金属球体73的粒径介于10um至100um之间。
如上述步骤S2所述,因第一混料30及第二混料35中的金属粉粒40为均一粒径,所以该骨支撑区71及该骨生长区72所含多个金属球体各具有均一粒径。
如上述步骤S2中,当多个金属粉粒40混合造孔剂50时,造孔剂50的重量百分比介于1wt%至70wt%之间,且造孔剂50主要为碳酸氢胺或聚甲基丙烯酸甲酯(PMMA),但本发明不限于此,造孔剂50进一步为高分子材料。
如上述,在一实施例中,其中多个连通孔74的孔径大小各介于50um至500um之间,骨支撑区71及骨生长区72的孔隙率各介于10%至90%之间,骨支撑区71及骨成长区72的弹性膜数介于0.17GPa至30GPa之间。
如上述步骤S2中所述,因第一混料30及第二混料35中的金属粉粒40于造孔剂50中为均匀分布,所以经烧结后所形成于椎间植入物70的多孔结构的孔洞分别均匀分布。
本发明椎间植入物70进一步包括一弧面95的设计,使在手术时易于植入椎间,另外,椎间植入物70进一步包括器械挟持部96,方便夹具挟持,使手术作业效率提升。
如上述,椎间植入物70包括骨支撑区71及骨生长区72的结构,分别具有相异的孔隙率及孔隙大小,但本发明不限于此,椎间植入物可经由制具设计为一多个区域结构,再调配出含有不同重量百分比的造孔剂的混料,由最内层填满含有重量百分比最高的造孔剂的混料依序逐层向外填满含有重量百分比较低的造孔剂的混料,接着经真空烧结后形成具有多个区域的椎间植入物,使椎间植入物具备多重刚性。
本发明椎间植入物是由多个均一粒径的金属球体所组成,且具有多个区域,各区分别因添加造孔剂于金属粉粒的重量百分比不同,形成具有相异数量的多个均一金属球体,使各区具有相异的孔隙率及孔隙大小,使椎间植入物为具有多重刚性的复合孔隙结构。因椎间植入物具有多重刚性,所以植入腰椎椎间时,可承受由腰椎活动时所产生的各种应力。且椎间植入物的各层孔隙均匀分布,使骨生长时与腰椎椎间植体融合的效率提升。
本发明具有复合孔隙结构的椎间植入物更接近人体椎间骨格力学性能的仿生异相多孔金属植体医材,当腰椎椎间植体植入人体椎间,使人体活动时,椎间可承受的应力效果更佳。
当然,本发明还可有其他多种实施例,在不背离本发明精神及其实质的情况下,熟悉本领域的技术人员当可根据本发明作出各种相应的改变和变形,但这些相应的改变和变形都应属于本发明所附的权利要求的保护范围。
Claims (10)
1.一种椎间植入物,其特征在于,由多个金属球体所组成的一多孔结构,且该椎间植入物包括一骨支撑区及一骨成长区;
其中,该骨支撑区及该骨成长区各具有多个连通孔,且该骨支撑区的孔隙率小于该骨成长区的孔隙率。
2.根据权利要求1所述的椎间植入物,其特征在于,该多孔结构由多个金属球体混合一造孔剂,以真空烧结成该多个金属球体所组成。
3.根据权利要求1所述的椎间植入物,其特征在于,该骨支撑区及该骨生长区所含多个金属球体各具有均一粒径。
4.根据权利要求2所述的椎间植入物,其特征在于,当该多个金属粉粒混合该造孔剂时,该造孔剂的重量百分比介于1wt%至70wt%之间。
5.根据权利要求1所述的椎间植入物,其特征在于,该多个金属球体的粒径介于10um至100um之间。
6.根据权利要求1所述的椎间植入物,其特征在于,该多个连通孔的孔径大小各介于50um至500um之间。
7.根据权利要求1所述的椎间植入物,其特征在于,该骨支撑区及该骨生长区的孔隙率各介于10%至90%之间。
8.根据权利要求1所述的椎间植入物,其特征在于,该骨支撑区及该骨成长区的弹性模量介于0.17GPa至30GPa之间。
9.根据权利要求1所述的椎间植入物,其特征在于,该多孔结构的孔洞分别均匀分布。
10.一种椎间植入物的制造方法,其特征在于,包括:
提供一制具,该制具区分有一骨支撑形成区及一骨成长形成区;
以金属粉粒混合造孔剂,形成一第一混料及一第二混料,该第一混料的造孔剂含量小于该第二混料的造孔剂含量;
填充该第一混料于该骨支撑形成区,且填充该第二混料于该骨生长形成区,经真空烧结后,形成具有该骨支撑区及该骨成长区的一椎间植入物,且该骨支撑区的孔隙率小于该骨成长区的孔隙率。
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US20150150689A1 (en) | 2015-06-04 |
TWI607736B (zh) | 2017-12-11 |
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