CN106039424A - 一种用于骨骼固定的新型聚乳酸玻纤复合材料 - Google Patents

一种用于骨骼固定的新型聚乳酸玻纤复合材料 Download PDF

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CN106039424A
CN106039424A CN201610353835.4A CN201610353835A CN106039424A CN 106039424 A CN106039424 A CN 106039424A CN 201610353835 A CN201610353835 A CN 201610353835A CN 106039424 A CN106039424 A CN 106039424A
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陈照峰
叶信立
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Nanjing Fengyuan New Materials Technology Co Ltd
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Abstract

本发明公开了一种用于骨骼固定的新型聚乳酸玻纤复合材料,按轴向方向包括:聚乳酸纤维层和超细玻璃纤维纸层,聚乳酸纤维层包括聚乳酸立构复合物、聚乙醇酸纤维和TiNi反向记忆合金,聚乳酸立构复合物和聚乙醇酸纤维交错分布,形成多孔的网络结构,TiNi反向记忆合金填充于网络结构中;超细玻璃纤维纸层由多层超细纤维纸叠加而成,其间隙和贴聚乳酸纤维层侧表面均匀地散落有能够随着聚乳酸纤维层温度的升高而固化的粘结剂,超细玻璃纤维纸层与聚乳酸纤维层紧密贴合。本发明利用了聚乳酸的生物可相容性,改善了聚乳酸玻纤复合材料的力学性能,可根据骨骼的形状进行变形,能够使外固定件紧紧贴合在骨骼外表面皮肤,稳固骨骼,同时本发明保温性能好、厚度薄且成本低。

Description

一种用于骨骼固定的新型聚乳酸玻纤复合材料
技术领域
本发明专利涉及一种聚乳酸玻纤复合材料,特别是涉及一种用于骨骼固定的新型聚乳酸玻纤复合材料。
技术背景
传统的骨科手术通常采用金属材料(钛合金、不锈钢等)内固定物进行接骨、复位固定、修复等。此类金属材料器件力学性能稳定,外形保持性良好,可以使骨折准确复位,促进骨骼愈合,是目前治疗骨折的主要选用器件,但是这类金属内固定物在创伤愈合后继续保留在患者体内,强度没有变化,容易在骨愈合过程中产生应力遮挡,不利于新生骨的生长,导致骨折愈合后可能再次发生骨折的危险。因此,绝大多数此类金属内固定物在创伤治愈后需要二次手术进行拆除,这样不但增加了患者的痛苦,而且增加了患者的治疗费用。另外,该类金属内固定物植入人体后患者不宜进行放射性和核磁共振检查,从而影响对患者病情的深入观察及治疗。使用可生物降解高分子材料器件代替金属材料器件是骨科内固定器件的发展趋势。
聚乳酸具有良好的生物相容性、无毒、无抗原性,可以完全降解,无需二次手术取出等优点,是当前医用的主要生物降解高分子材料器件。但是,它的初始力学强度不高,只能用于非承重骨的内固定,而不能用于四肢长管状骨骼的内固定。传统的骨骼内固定件使用聚乳酸作为载体,利用其生物相容性进行骨骼的修复,但是此类骨骼内固定材料也同时存在成本相对偏高、危险系数较高的缺点而不能得到广泛的应用。
现有技术对于骨骼的外固定多采用材质较硬的固定板进行固定,不能即时根据人体骨骼的形状进行调整,会出现固定不紧密的现象,因此急需一种新型的骨骼固定装置来解决此问题。
发明内容
本发明旨在克服现有技术的不足,提供一种可降解、保温性能好、厚度薄且成本低的用于骨骼固定的新型聚乳酸玻纤复合材料,该发明能够改善聚乳酸玻纤复合材料的力学性能,且可根据骨骼的形状进行变形,能够使外固定件紧紧贴合在骨骼外表面皮肤,稳固骨骼。
一种用于骨骼固定的新型聚乳酸玻纤复合材料,按轴向方向包括:
聚乳酸纤维层,为贴皮肤层,由生物降解材料制成,包括60~80wt%的聚乳酸立构复合物、15~30wt%的聚乙醇酸纤维和5~10wt%的TiNi反向记忆合金;聚乳酸立构复合物和聚乙醇酸纤维交错分布,形成孔径为10nm~20nm的多孔网络结构,TiNi反向记忆合金填充于所述网络结构中,所述聚乙醇酸纤维不仅保持聚乙醇酸的生物相容性和生物降解性,还具有优异的力学性能;
超细玻璃纤维纸层,由多层超细纤维纸叠加而成,纸与纸之间的间隙和贴聚乳酸纤维层侧表面均匀地散落有能够随着聚乳酸纤维层温度的升高而固化的粘结剂,超细玻璃纤维纸层与聚乳酸纤维层紧密结合。
所述的聚乳酸立构复合物是采用等摩尔比的D-聚乳酸和L-聚乳酸、利用熔融共混法制得,或者采用等摩尔比的D-聚乳酸和L-聚乳酸聚合制得。
所述的粘结剂是超细玻璃纤维棉毡用粘结剂,其主要成分是硫酸铵、γ-氨丙基三乙氧基硅烷、甲基硅油、氨水、矿物油和自交联苯乙烯丙烯酸酯类聚合物,在所述的超细玻璃纤维质层中的体积含量为10%~20%。
所述的聚乳酸纤维层的厚度为2mm~4mm。
所述的超细玻璃纤维纸的厚度为2μm~10μm,所述的超细玻璃纤维纸层的厚度为3mm~6mm。
所述的一种用于骨骼固定的新型聚乳酸玻纤复合材料的使用方法是:所述聚乳酸纤维层制成后在30℃以下储存,使用时,将所述超细玻璃纤维纸层与聚乳酸纤维层紧密贴合,贴于皮肤表面。
本发明的有益效果是:(1)聚乳酸纤维层的生物可相容性好,应用于骨骼外固定时,对皮肤表面的刺激性较小,长期使用对人体无任何副作用,另外聚乳酸纤维层的保温性能较好,人体热量不易散失,利于骨骼的自我恢复;(2)添加粘结剂之后的超细玻璃纤维纸层的力学性能能够得到较大的改善,同时能紧紧贴合聚乳酸纤维层,起到保护内层的作用;(3)聚乳酸玻纤外固定件较传统的材料厚度更薄、质量更轻、保温性能更好,且对人体不造成危害,成本也相对较低,另外可根据骨骼的形状进行变形,一旦贴合之后,聚乳酸纤维内层失去变形能力,超细玻璃纤维纸外层开始固化,外固定件能紧紧贴合在骨骼外表面皮肤,不受外力的影响而变形,起到稳固骨骼的作用。
具体实施方式
下面结合具体实施例,进一步阐明本发明。
实施例1
一种用于骨骼固定的新型聚乳酸玻纤复合材料,按轴向方向包括:
聚乳酸纤维层,为贴皮肤层,厚度为4mm,由生物降解材料制成,包括80wt%的聚乳酸立构复合物、30wt%的聚乙醇酸纤维和10wt%的TiNi反向记忆合金;聚乳酸立构复合物和聚乙醇酸纤维交错分布,形成孔径为20nm的多孔网络结构,TiNi反向记忆合金填充于所述网络结构中,所述的聚乳酸立构复合物是采用等摩尔比的D-聚乳酸和L-聚乳酸、利用熔融共混法制得;
超细玻璃纤维纸层,厚度为6mm,由厚度为10μm的超细纤维纸叠加而成,纸与纸之间的间隙和贴聚乳酸纤维层侧表面均匀地散落有能够随着聚乳酸纤维层温度的升高而固化的粘结剂,粘结剂在超细玻璃纤维质层中的体积含量为20%,超细玻璃纤维纸层与聚乳酸纤维层紧密贴合。
所述的粘结剂的主要成分是硫酸铵、γ-氨丙基三乙氧基硅烷、甲基硅油、氨水、矿物油和自交联苯乙烯丙烯酸酯类聚合物。
实施例2
一种用于骨骼固定的新型聚乳酸玻纤复合材料,按轴向方向包括:
聚乳酸纤维层,为贴皮肤层,厚度为2mm,由生物降解材料制成,包括60wt%的聚乳酸立构复合物、15wt%的聚乙醇酸纤维和5wt%的TiNi反向记忆合金;聚乳酸立构复合物和聚乙醇酸纤维交错分布,形成孔径为10nm的多孔网络结构,TiNi反向记忆合金填充于所述网络结构中,所述的聚乳酸立构复合物是采用等摩尔比的D-聚乳酸和L-聚乳酸聚合制得;
超细玻璃纤维纸层,厚度为6mm,由厚度为2μm的超细纤维纸叠加而成,纸与纸之间的间隙和贴聚乳酸纤维层侧表面均匀地散落有能够随着聚乳酸纤维层温度的升高而固化的粘结剂,粘结剂在超细玻璃纤维质层中的体积含量为10%,超细玻璃纤维纸层与聚乳酸纤维层紧密贴合。
所述的粘结剂的主要成分是硫酸铵、γ-氨丙基三乙氧基硅烷、甲基硅油、氨水、矿物油和自交联苯乙烯丙烯酸酯类聚合物。
实施例3
一种用于骨骼固定的新型聚乳酸玻纤复合材料,按轴向方向包括:
聚乳酸纤维层,为贴皮肤层,厚度为3mm,由生物降解材料制成,包括70wt%的聚乳酸立构复合物、23wt%的聚乙醇酸纤维和8wt%的TiNi反向记忆合金;聚乳酸立构复合物和聚乙醇酸纤维交错分布,形成孔径为15nm的多孔网络结构,TiNi反向记忆合金填充于所述网络结构中,所述的聚乳酸立构复合物是采用等摩尔比的D-聚乳酸和L-聚乳酸聚合制得;
超细玻璃纤维纸层,厚度为5mm,由厚度为6μm的超细纤维纸叠加而成,纸与纸之间的间隙和贴聚乳酸纤维层侧表面均匀地散落有能够随着聚乳酸纤维层温度的升高而固化的粘结剂,粘结剂在超细玻璃纤维质层中的体积含量为15%,超细玻璃纤维纸层与聚乳酸纤维层紧密贴合。
所述的粘结剂的其主要成分是硫酸铵、γ-氨丙基三乙氧基硅烷、甲基硅油、氨水、矿物油和自交联苯乙烯丙烯酸酯类聚合物。
实施例4
一种用于骨骼固定的新型聚乳酸玻纤复合材料,按轴向方向包括:
聚乳酸纤维层,为贴皮肤层,厚度为3mm,由生物降解材料制成,包括80wt%的聚乳酸立构复合物、23wt%的聚乙醇酸纤维和5wt%的TiNi反向记忆合金;聚乳酸立构复合物和聚乙醇酸纤维交错分布,形成孔径为15nm的多孔网络结构,TiNi反向记忆合金填充于所述网络结构中,所述的聚乳酸立构复合物是采用等摩尔比的D-聚乳酸和L-聚乳酸聚合制得;
超细玻璃纤维纸层,厚度为4mm,由厚度为6μm的超细纤维纸叠加而成,纸与纸之间的间隙和贴聚乳酸纤维层侧表面均匀地散落有能够随着聚乳酸纤维层温度的升高而固化的粘结剂,粘结剂在超细玻璃纤维质层中的体积含量为15%,超细玻璃纤维纸层与聚乳酸纤维层紧密贴合。
所述的粘结剂的主要成分是硫酸铵、γ-氨丙基三乙氧基硅烷、甲基硅油、氨水、矿物油和自交联苯乙烯丙烯酸酯类聚合物。
实施例5
一种用于骨骼固定的新型聚乳酸玻纤复合材料,按轴向方向包括:
聚乳酸纤维层,为贴皮肤层,厚度为3mm,由生物降解材料制成,包括60wt%的聚乳酸立构复合物、23wt%的聚乙醇酸纤维和10wt%的TiNi反向记忆合金;聚乳酸立构复合物和聚乙醇酸纤维交错分布,形成孔径为17nm的多孔网络结构,TiNi反向记忆合金填充于所述网络结构中,所述的聚乳酸立构复合物是采用等摩尔比的D-聚乳酸和L-聚乳酸聚合制得;
超细玻璃纤维纸层,厚度为4mm,由厚度为8μm的超细纤维纸叠加而成,纸与纸之间的间隙和贴聚乳酸纤维层侧表面均匀地散落有能够随着聚乳酸纤维层温度的升高而固化的粘结剂,粘结剂在超细玻璃纤维质层中的体积含量为18%,超细玻璃纤维纸层与聚乳酸纤维层紧密贴合。
所述的粘结剂的主要成分是硫酸铵、γ-氨丙基三乙氧基硅烷、甲基硅油、氨水、矿物油和自交联苯乙烯丙烯酸酯类聚合物。
实施例6
一种用于骨骼固定的新型聚乳酸玻纤复合材料,按轴向方向包括:
聚乳酸纤维层,为贴皮肤层,厚度为3mm,由生物降解材料制成,包括70wt%的聚乳酸立构复合物、30wt%的聚乙醇酸纤维和5wt%的TiNi反向记忆合金;聚乳酸立构复合物和聚乙醇酸纤维交错分布,形成孔径为12nm的多孔网络结构,TiNi反向记忆合金填充于所述网络结构中,所述的聚乳酸立构复合物是采用等摩尔比的D-聚乳酸和L-聚乳酸、利用熔融共混法制得;
超细玻璃纤维纸层,厚度为4mm,由厚度为4μm的超细纤维纸叠加而成,纸与纸之间的间隙和贴聚乳酸纤维层侧表面均匀地散落有能够随着聚乳酸纤维层温度的升高而固化的粘结剂,粘结剂在超细玻璃纤维质层中的体积含量为12%,超细玻璃纤维纸层与聚乳酸纤维层紧密贴合。
所述的粘结剂的主要成分是硫酸铵、γ-氨丙基三乙氧基硅烷、甲基硅油、氨水、矿物油和自交联苯乙烯丙烯酸酯类聚合物。
实施例7
一种用于骨骼固定的新型聚乳酸玻纤复合材料,按轴向方向包括:
聚乳酸纤维层,为贴皮肤层,厚度为3mm,由生物降解材料制成,包括70wt%的聚乳酸立构复合物、15wt%的聚乙醇酸纤维和10wt%的TiNi反向记忆合金;聚乳酸立构复合物和聚乙醇酸纤维交错分布,形成孔径为15nm的多孔网络结构,TiNi反向记忆合金填充于所述网络结构中,所述的聚乳酸立构复合物是采用等摩尔比的D-聚乳酸和L-聚乳酸、利用熔融共混法制得;
超细玻璃纤维纸层,厚度为4mm,由厚度为4μm的超细纤维纸叠加而成,纸与纸之间的间隙和贴聚乳酸纤维层侧表面均匀地散落有能够随着聚乳酸纤维层温度的升高而固化的粘结剂,粘结剂在超细玻璃纤维质层中的体积含量为15%,超细玻璃纤维纸层与聚乳酸纤维层紧密贴合。
所述的粘结剂的主要成分是硫酸铵、γ-氨丙基三乙氧基硅烷、甲基硅油、氨水、矿物油和自交联苯乙烯丙烯酸酯类聚合物。
实施例1~7所述的一种用于骨骼固定的新型聚乳酸玻纤复合材料的使用方法是:所述聚乳酸纤维层制成后在30℃以下储存,使用时,将所述超细玻璃纤维纸层与聚乳酸纤维层紧密贴合,贴于皮肤表面时。
本发明的工作原理是:贴于皮肤表面时,所述聚乳酸纤维层表面温度低于30℃,所述聚乳酸纤维层根据骨骼外表面皮肤进行变形,随着热量的传递,所述TiNi反向记忆合金失去变形能力,紧紧贴敷在皮肤外表面,所述多孔的网络结构大大增加了整个聚乳酸玻纤外固定件的保温性能,利于骨骼的恢复;同时,随着聚乳酸纤维层的温度的慢慢升高,超细玻璃纤维纸层的粘结剂开始固化,使超细玻璃纤维质层的力学性能大大增强,整个聚乳酸玻纤外固定件的机械性能得到加强,从而起到了稳固骨骼的作用,同时也保护外固定件因外力而破裂。
总之,本发明提供的一种用于骨骼固定的新型聚乳酸玻纤复合材料利用了聚乳酸的生物可相容性,能够改善聚乳酸玻纤复合材料的力学性能,且可根据骨骼的形状进行变形,能够使外固定件紧紧贴合在骨骼外表面皮肤,稳固骨骼,同时本发明保温性能好、厚度薄且成本低。

Claims (7)

1.一种用于骨骼固定的新型聚乳酸玻纤复合材料,其特征在于:按轴向方向包括:
聚乳酸纤维层,为贴皮肤层,包括60~80wt%的聚乳酸立构复合物、15~30wt%的聚乙醇酸纤维和5~10wt%的TiNi反向记忆合金;聚乳酸立构复合物和聚乙醇酸纤维交错分布,形成多孔的网络结构,TiNi反向记忆合金填充于所述网络结构中;
超细玻璃纤维纸层,由多层超细纤维纸叠加而成,纸与纸之间的间隙和贴聚乳酸纤维层侧表面均匀地散落有能够随着聚乳酸纤维层温度的升高而固化的粘结剂,超细玻璃纤维纸层与聚乳酸纤维层紧密贴合。
2.根据权利要求1所述的用于骨骼固定的新型聚乳酸玻纤复合材料,其特征在于:所述的聚乳酸立构复合物是采用等摩尔比的D-聚乳酸和L-聚乳酸、利用熔融共混法制得,或者采用等摩尔比的D-聚乳酸和L-聚乳酸聚合制得。
3.根据权利要求1所述的用于骨骼固定的新型聚乳酸玻纤复合材料,其特征在于:所述的粘结剂的主要成分是硫酸铵、γ-氨丙基三乙氧基硅烷、甲基硅油、氨水、矿物油和自交联苯乙烯丙烯酸酯类聚合物,所述的粘结剂在所述的超细玻璃纤维质层中的体积含量为10~20%。
4.根据权利要求1所述的用于骨骼固定的新型聚乳酸玻纤复合材料,其特征在于:所述的聚乳酸纤维层的厚度为2mm~4mm。
5.根据权利要求1所述的用于骨骼固定的新型聚乳酸玻纤复合材料,其特征在于:所述的多孔的网络结构的孔径为10nm~20nm。
6.根据权利要求1所述的用于骨骼固定的新型聚乳酸玻纤复合材料,其特征在于:所述的超细玻璃纤维纸的厚度为2μm~10μm,所述的超细玻璃纤维纸层的厚度为3mm~6mm。
7.根据权利要求1~6任一项所述的用于骨骼固定的新型聚乳酸玻纤复合材料,其特征在于:所述的新型聚乳酸玻纤复合材料的使用方法是,所述聚乳酸纤维层制成后在30℃以下储存,使用时,将所述超细玻璃纤维纸层与聚乳酸纤维层紧密贴合,贴于皮肤表面。
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