CN105796170A - 一种骨折固定用多孔钽金属螺钉及其应用 - Google Patents
一种骨折固定用多孔钽金属螺钉及其应用 Download PDFInfo
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Abstract
本发明公开了一种骨折固定用多孔钽金属螺钉,包括螺钉本体,螺钉本体的前端设置有前端螺纹段,所述螺钉本体的后端设置有后端螺纹段,所述前端螺纹段和后端螺纹段之间为光滑的圆杆,其特征在于,所述后端螺纹段的螺纹螺距小于前端螺纹段的螺纹螺距,所述后端螺纹段的螺纹深度大于前端螺纹段的螺纹深度,所述后端螺纹段的端部的两侧外表面以螺钉本体中心线对称开有凹槽,所述凹槽的两斜面夹角为30。本发明的螺钉的结构,有利于其拧入及牢靠的固定,防止骨折处再移位的发生,可避免螺钉拧入时尾部变形的缺点,从而使力均一的达到前端,减少了螺钉变形及断裂的可能。
Description
技术领域
本发明涉及一种医用永久性植入物,特别是一种用于股骨颈骨折治疗的医用植入物的多孔钽金属螺钉。
背景技术
股骨颈骨折是临床常见的疾病,尤其是老年股骨颈患者,可能要面对长期卧床或人工关节置换的命运;因此针对其治疗也存在一定的争议,多数学者认为新鲜股骨颈骨折的治疗原则应力求早期,解剖复位,牢固固定;然而目前内固定方式基本上均采用空心加压螺钉固定。目前临床上多采用钛金属所制成的空心螺钉,虽然目前取得了一定的临床效果,但其无诱导骨生成、二次取出等临床弊端。
多孔医用金属植入材料具有治疗骨组织创伤和诱导骨组织再生等重要而特殊的用途,现常见的这类材料有多孔不锈钢、多孔钛等。作为骨组织创伤、缺损治疗使用的多孔植入材料,其孔隙度应达到30-85%,而且孔隙最好全部连通和均匀分布,或根据需要孔隙部分连通和均匀分布,使之既与人体的骨组织生长相一致,又减轻了材料本身的重量,以适合人体植入使用。
金属钽对人体无毒害等副作用,具有很好的生物相容性和力学性能,其多孔材料有望替代前述传统医用金属生物材料,有望成为股骨颈骨折治疗领域的主要生物材料。随着国内外医学的飞速发展,对钽作为人体植入材料的进一步认知,人们对人体植入用多孔金属钽材料的需求变得越来越迫切,对其要求也越来越高。其中作为多孔医用植入金属钽,如果能具有很高的均匀分布连通孔隙以及与人体相适应的物理机械性能,则是保证新生骨组织正常生长的重要连接件构成材料。
关于多孔钽这类材料,US5282861公开了一种应用于松质骨植入体、细胞和组织感受器的开孔钽材料及其制备。这种多孔钽由纯商业钽制成,它以聚亚氨酯前体进行热降解得到的碳骨架为支架,该碳骨架呈多重的十二面体,其内为网格样结构,整体遍布微孔,孔隙率可高达98%,再将商业纯钽通过化学蒸气沉积、渗透的方法结合到碳骨架上以形成多孔金属微结构,简称化学沉积法。这种方法所获得的多孔钽材料其表面的钽层厚度在40-60μm之间;在整个多孔材料中,钽比重约占99%,而碳骨架重量则占1%左右。文献进一步记载,该多孔材料的抗压强度50-70MPa,弹性模量2.5-3.5GPa,抗拉强度63MPa,塑性变形量15%。
目前在临床上用于固定股骨颈骨折的螺钉,多为空心加压螺钉,有多种结构,如金属钛材质的空心螺钉等,具有较短的三角形螺纹结构,还有其他材料构成的空心螺钉等,其尾部钉帽多为圆形结构。普遍存在结构复杂、生物力学效能不强、机械力度不够、需要二次取出等临床常见问题,在应用中常常出现内固定螺钉断裂、骨折再次移位等问题。
发明内容
本发明的目的在于针对上述现有用于固定股骨颈骨折的螺钉存在的问题,提供一种用于固定股骨颈骨折的多孔钽金属螺钉。该多孔钽金属螺钉结构简单、具有较好的力学强度以及生物效能较好、内固定牢固性能、同时具有较高组织相容性和生物力学性能,可诱导骨组织生成,便于骨组织的长入。
本发明的技术方案为如下:
一种骨折固定用多孔钽金属螺钉,包括螺钉本体,螺钉本体的前端设置有前端螺纹段,所述螺钉本体的后端设置有后端螺纹段,所述前端螺纹段和后端螺纹段之间为光滑的圆杆,其特征在于,所述后端螺纹段的螺纹螺距小于前端螺纹段的螺纹螺距,所述后端螺纹段的螺纹深度大于前端螺纹段的螺纹深度,所述后端螺纹段的端部的两侧外表面以螺钉本体中心线对称开有凹槽,所述凹槽的两斜面夹角为30°。
上述技术方案中所述的多孔钽金属螺钉为实心螺钉。
进一步地,后端螺纹段的螺纹螺距与前端螺纹段的螺纹螺距的比为8~9:10,所述后端螺纹段的螺纹深度与前端螺纹段的螺纹深度的比为10:8~9。
进一步地,所述前端螺纹段的长度与螺钉本体的长度比为1:3.5~4.5。
进一步地,所述后端螺纹段的长度与螺钉本体的长度比为1:3.0~4.5。
进一步地,所述凹槽的长度与螺钉本体的长度比为1:8~10。
进一步地,前端螺纹段螺纹的螺纹和后端螺纹段螺纹均为楔形螺纹。这样的设计减少了螺钉进入前的自攻过程,减少骨质的进一步丢失,加强骨折处的内固定强度。
进一步地,所述前端螺纹段螺纹为英制螺纹,其牙型角为55°。
进一步地,所述后端螺纹段螺纹为公制螺纹,其牙型角为60。
进一步地,本发明的多孔钽金属螺钉中,所述的前端螺纹段的最大螺纹大径与后端螺纹段的螺纹大径相同,所述螺纹大径与螺钉圆杆的直径的比为1.2-1.5:1。螺钉螺杆是指非螺钉的非螺纹部分。
本发明的骨折固定用多孔钽金属螺钉的后端螺纹段的螺纹相对于前端螺纹段的螺纹,其螺距加窄,螺纹深度加深,这样的设计有利于螺钉的把持防止其退钉,有利于骨折部位的坚强固定。
进一步地,上述所述的多孔钽金属螺钉,采用的材料是利用化学气相沉积方法,将钽金属化合物还原为钽金属粉,均匀沉积于石墨碳骨架、碳化硅骨架或玻璃碳纤维支架表面形成钽涂层制备得到,其中所述钽金属化合物为五氯化钽、氟化钽中的一种;所述石墨碳骨架、碳化硅支架或玻璃碳纤维支架的孔隙率>85%,孔径为200-600μm;所述钽涂层的厚度为40-60μm。
上述用于制备所述多孔钽金属螺钉的材料的孔隙度为85%,孔径为200-600μm,且至少80%多面体相互交织的网状结构,具有孔隙三维连通分布的十二面体网状结构,有利于骨细胞和组织的长入。
本发明还提供上述骨折固定用多孔钽金属螺钉的制备方法,包括如下步骤:
(1)将权利要求9所述石墨碳骨架、碳化硅骨架或玻璃碳纤维支架用稀盐酸浸蚀10-20min,依次用水和乙醇清洗后用氮气吹干,置入反应室内;
(2)反应室内同时通入处理气体和氢气,在900-1050℃,真空度10-15Pa条件下,反应4-6小时;
其中:所述处理气体包含钽金属化合物和载气,将钽金属化合物放入源罐中,加热至120-250℃,300℃惰性气体为载气通入至反应室;
所述惰性气体为氩气、氦气中的一种或两种的混合;
所述处理气体的流量为80-100ml/min;
所述氢气的流量为100-150ml/min。
本发明的有益效果:
1.本发明的骨折固定用多孔钽金属螺钉具有前端螺纹段和后端螺纹段,且后端螺纹段的螺纹相对于前端螺纹段的螺纹,其螺距较窄,螺纹深度加深,这样的设计有利于螺钉的把持防止其退钉,有利于骨折部位的坚强固定。
2.本发明的螺钉,后端螺纹段的端部的两侧外表面以螺钉本体中心线对称开有凹槽,作为拧紧工具的把持部,把持部的两个侧面具有螺纹,有利于螺钉与骨皮质的贴合,提高了螺钉在固定部位的固定作用,不易松动。
3.本发明的螺钉,前端螺纹段螺纹为英制螺纹,其牙型角55°,而后端螺纹段的螺纹为公制螺纹,其牙型角60°,这样的设计有利于螺钉的坚强固定,防止其松动退钉的现象发生。
4.本发明的螺钉可避免螺钉拧入时尾部变形的缺点,从而使力均一的达到前端,减少了螺钉变形及断裂的可能;把持部具有螺纹,具有更加良好的把持固定作用;避免了在植入皮质骨等坚硬骨质时螺钉的变形及断裂;无需二次手术取出,减轻患者痛苦。
本发明的多孔钽金属螺钉,有利于新生骨的生成及替代骨的作用,尤其股骨颈骨折的治疗中有较好的临床效果,本发明的多孔钽金属螺钉的材料具有十二面体立体网状结构,其结构与松质骨骨小梁类似,具有较高组织相容性,可诱导骨组织生成,便于骨组织的长入;而且具有较强的生物力学性能,可提供一定的力学支撑,达到诱导及替代骨组织的目的。本发明的多孔钽金属螺钉,其制备方法简单、成本低,有利于实施和临床应用,适合于广大患者的需要。
附图说明
图1为本发明多孔钽金属螺钉的结构示意图。
图2为本发明多孔钽金属螺钉后端螺纹段的端部凹槽的结构示意图。
附图标号:1、螺钉本体,11、前端螺纹段,12、后端螺纹段,13、螺钉本体圆杆,2、凹槽,L1、前端螺纹段的长度,L2、后端螺纹段的而长度,L3、螺钉本体圆杆的长度。
具体实施方式
下述非限制性实施例可以使本领域的普通技术人员更全面地理解本发明,但不以任何方式限制本发明。
实施例1
如图1-2所示,一种骨折固定用多孔钽金属螺钉,包括螺钉本体1,螺钉本体的前端设置有前端螺纹段11,所述螺钉本体的后端设置有后端螺纹段12,所述前端螺纹段和后端螺纹段之间为光滑的圆杆13,所述前端螺纹段11、后端螺纹段12和圆杆13是一体化结构,所述后端螺纹段的端部的两侧外表面以螺钉本体中心线对称开有凹槽,所述凹槽的两斜面夹角为30°,该螺钉为实心螺钉。所述螺钉本体的总长度为85mm,所述前端螺纹段长度L1为20.6mm,所述后端螺纹段长度L2为26mm,螺钉本体圆杆的长度L3为38.4mm,所述凹槽的长度为10mm。所述前端螺纹段11为英制螺纹,其牙型角为55°,前螺纹的最大螺纹大径为10.4mm,最大螺纹小经为7mm,螺距为4mm;后端螺纹段12为公制螺纹,其牙型角为60°,螺纹的螺纹大径为10.4mm,最大螺纹小经为8mm,螺距为3.5mm;
在具体使用中根据植入部位的大小、组织等特点,可以适当调节所述螺钉的具体尺寸,以达到最好的治疗效果。
实施例2
实施例1所述的多孔钽金属螺钉,用如下方法制备得到:
(1)将孔隙率为85%的石墨碳骨架、碳化硅骨架或者玻璃碳骨架用稀盐酸浸蚀10min,依次用水和乙醇清洗后用氮气吹干,置入反应室内;
(2)将粒径为400目的五氯化碳粉末放入源罐中,加热至150℃,以高温氩气(300℃)为载气通入至反应室,载气流量为100ml/min,反应室温度为1050℃,反应室真空度为10Pa;反应室中通入以氩气为载气通入五氯化钽粉末的同时,以120ml/min流量通入氢气,还原反应4小时,使还原成金属粉末的钽金属均匀沉积于石墨碳、碳化硅、玻璃碳纤维等骨架表面以及其空隙表面,得本发明的多孔钽金属螺钉成品。
多孔钽金属螺钉本体材料的孔隙率为85%,弹性模量为10GPa,最大抗压强度为35MPa.,其中孔隙率为根据国家标准GB/T21650.1-2008,弹性模量为根据国家标准GB/T22315-2008中所述的方法检测。
所述多孔钽金属螺钉本体材料,具有孔隙三维连通分布的十二面体网状结构,其结构与松质骨骨小梁类似,具有较高组织相容性,可诱导骨组织生成,便于骨组织的长入;而且具有较强的生物力学性能,可提供一定的力学支撑,达到促进骨折愈合及修复、填充骨缺损的目的。
在上述制备方法中,首先将石墨碳骨架、碳化硅骨架或者玻璃碳骨架加工成图1所述的形状,然后经步骤(1)~(2)其制备成本发明的多孔钽金属螺钉。
Claims (10)
1.一种骨折固定用多孔钽金属螺钉,包括螺钉本体,螺钉本体的前端设置有前端螺纹段,所述螺钉本体的后端设置有后端螺纹段,所述前端螺纹段和后端螺纹段之间为光滑的圆杆,其特征在于,所述后端螺纹段的螺纹螺距小于前端螺纹段的螺纹螺距,所述后端螺纹段的螺纹深度大于前端螺纹段的螺纹深度,所述后端螺纹段的端部的两侧外表面以螺钉本体中心线对称开有凹槽,所述凹槽的两斜面夹角为30°。
2.根据权利要求1所述的多孔钽金属螺钉,其特征在于,后端螺纹段的螺纹螺距与前端螺纹段的螺纹螺距的比为8~9:10,所述后端螺纹段的螺纹深度与前端螺纹段的螺纹深度的比为10:8~9。
3.根据权利要求1所述的多孔钽金属螺钉,其特征在于,所述前端螺纹段的长度与螺钉本体的长度比为1:3.5~4.5。
4.根据权利要求1所述的多孔钽金属螺钉,其特征在于,所述后端螺纹段的长度与螺钉本体的长度比为1:3.0~4.5。
5.根据权利要求1所述的多孔钽金属螺钉,其特征在于,所述凹槽的长度与螺钉本体的长度比为1:8~10。
6.根据权利要求1所述的多孔钽金属螺钉,其特征在于,前端螺纹段螺纹后端螺纹段螺纹均为楔形螺纹。
7.根据权利要求1所述的多孔钽金属螺钉,其特征在于,所述前端螺纹段螺纹为英制螺纹,其牙型角为55°。
8.根据权利要求1所述的多孔钽金属螺钉,其特征在于,所述后端螺纹段螺纹为公制螺纹,其牙型角为60°。
9.根据权利要求1的所述的多孔钽金属螺钉,其特征在于,所述螺钉采用的材料是利用化学气相沉积方法,将钽金属化合物还原为钽金属粉,均匀沉积于石墨碳骨架、碳化硅骨架或玻璃碳纤维支架表面形成钽涂层制备得到,其中所述钽金属化合物为五氯化钽、氟化钽中的一种;所述石墨碳骨架、碳化硅支架或玻璃碳纤维支架的孔隙率>85%,孔径为200-600μm;所述钽涂层的厚度为40-60μm。
10.一种如权利要求9所述的多孔钽金属螺钉的制备方法,其特征在于,包括如下步骤:
(1)将权利要求9所述石墨碳骨架、碳化硅骨架或玻璃碳纤维支架用稀盐酸浸蚀10-20min,依次用水和乙醇清洗后用氮气吹干,置入反应室内;
(2)反应室内同时通入处理气体和氢气,在900-1050℃,真空度10-15Pa条件下,反应4-6小时;
其中:所述处理气体包含钽金属化合物和载气,将钽金属化合物放入源罐中,加热至120-250℃,300℃惰性气体为载气通入至反应室;
所述惰性气体为氩气、氦气中的一种或两种的混合;
所述处理气体的流量为80-100ml/min;
所述氢气的流量为100-150ml/min。
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