CN106178104B - 一种医用可载药多孔聚醚醚酮及其制造方法和应用 - Google Patents
一种医用可载药多孔聚醚醚酮及其制造方法和应用 Download PDFInfo
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Abstract
本发明涉及一种医用可载药多孔聚醚醚酮及其制造方法和应用,该医用聚醚醚酮具有均匀的多孔结构或呈梯度变化多孔结构,孔径大小为0.05‑2mm,孔隙率为10%‑90%。该材料制备过程中熔融态聚醚醚酮通过压力铸造等方式挤压进入预制体孔隙中,然后通过化学方法腐蚀掉预制体,形成多孔的聚醚醚酮。该材料具有优异力学性能,并且孔径大小和孔隙率可以控制。该材料多孔结构中可根据需要载入药物,起到预防感染,促进骨生长和愈合的作用。与现有技术相比,本发明具有操作简单易行,结构可控,载药方便,药物结合牢固,成本低等优点。
Description
技术领域
本发明属于生物医用材料领域,具体涉及一种医用可载药多孔聚醚醚酮及其制备方法,制备的材料主要用于人工关节、脊柱融合、骨修复和骨移植等方面。
背景技术
聚醚醚酮具有良好的力学性能、化学稳定性和生物相容性,可耐受蒸气和辐照消毒。因此聚醚醚酮医用材料获得广泛的临床应用。聚醚醚酮作为生物惰性材料,难以和人体骨骼形成骨融合,限制了其作为骨修复材料的应用。
针对这一不足,许多学者应用不同的方法处理PEEK,以提高其成骨效能;包括:PEEK-羟基磷灰石(HA)复合材料、PEEK-HA-碳纤维复合材料、纳米氟磷灰石-PEEK复合材料、纳米二氧化钛-PEEK复合材料等等。
这些方法的确改善了PEEK的生物活性,然而生物活性物质与聚醚醚酮的结合不够紧密,造成在植入和应用过程中涂层易脱落,使得植入体达不到应有的效果。
医用材料中的孔可以为骨细胞生长和体液传输提供通道,有利于材料和骨的结合,并且多孔结构可以作为药物的载体。所以设计具有多孔结构的医用聚醚醚酮具有十分重要的意义。根据需要在多孔聚醚醚酮多孔结构载药可以起到增加表面活性、促进骨细胞生长和分化、预防感染、针对性给药、局部给药等作用。
发明内容
本发明的目的就是为了克服克服目前医用聚醚醚酮的不足,提供一种医用可载药多孔聚醚醚酮及其制造方法和应用。该材料具有孔径大小和孔隙率可控的多孔结构,有利于骨细胞生长和体液传输。多孔结构中可根据需要载入药物,起到预防感染,促进骨生长和愈合的作用。该材料可满足人工关节、脊柱融合材料和骨支撑修复材料等植入需要。
本发明的目的可以通过以下技术方案来实现:一种医用可载药多孔聚醚醚酮,其特征在于,该医用聚醚醚酮具有均匀的多孔结构或呈梯度变化多孔结构,孔径大小为0.05-2mm,孔隙率为10%-90%。
所述的多孔聚醚醚酮的抗压屈服强度范围为1MPa-120MPa,弹性模量范围为0.1GPa-20GPa。
所述的多孔聚醚醚酮孔的大小和孔隙率可根据需要调节。
所述的聚醚醚酮中可根据需要添加短纤维增强相或颗粒增强相,所述的短纤维增强相选自碳纤维、氧化物晶须或生物玻璃纤维,所述的颗粒增强相选自物玻璃颗粒、钽粉或羟基磷灰石粉。
该方法包括以下步骤:熔融态聚醚醚酮通过压力铸造方式挤压进入预制体孔隙中,然后通过化学方法腐蚀掉预制体,形成多孔的聚醚醚酮。
所述的预制体为钛丝,锆丝,铝丝或不锈钢丝缠绕编织而成。
所述的预制体所用金属丝直径为0.05-2mm,预制体孔隙率为10%-90%。
所述的腐蚀掉预制体采用的化学腐蚀剂为氢氟酸、盐酸、硝酸、硫酸或王水。
一种医用可载药多孔聚醚醚酮的应用,其特征在于,在聚醚醚酮的孔中根据需要载入药物,药物通过激光熔覆、渗透法、包埋法、溶剂挥干法、熔融法或吸附平衡法载入。
所载药物包括生物相容性好的物质、预防术后感染的药物、促进骨细胞生长的元素,抗肿瘤的药物或生长因子;
所述的生物相容性好的物质包括钽粉、羟基磷灰石、硅酸钙、磷酸钙或硫酸钙等;
所述的预防术后感染的药物包括银离子、硫酸庆大霉素或万古霉素;
所述的促进骨细胞生长的元素包括锶、锌、锂、钙。
本发明材料具有均匀的多孔结构或呈梯度变化多孔结构,孔内可载药,起到预防感染,促进骨生长和愈合的作用。制备过程中熔融态聚醚醚酮通过压力铸造等方式挤压进入预制体孔隙中。因为聚醚醚酮具有优良的耐蚀性,几乎不被浓硫酸意外的任何酸服饰。所以可以通过化学方法腐蚀掉预制体,形成多孔的聚醚醚酮。
与现有技术相比,本发明多孔聚醚醚酮具有以下优点:
1.具有优良的力学性能,骨传输和骨诱导能力;
2.操作简便,制造成本低;
3.力学性能可调;
4.多孔结构孔径大小、分布和孔隙率可根据需要调节;
5.材料形状和大小容易控制,可根据植入需要设计;
6.载药方便,药物结合牢固;
7.可以满足大多数人工关节、脊柱融合、骨填充、骨修复和骨移植的需求。
附图说明
图1为医用可载药多孔聚醚醚酮形貌图。
具体实施方式
下面对本发明的实施例作详细说明,本实施例在以本发明技术方案为前提下进行实施,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限于下述的实施例。
实施例1
采用直径为0.05mm的钛丝,缠绕编织成设定形状,其孔隙率为10%,通过压力铸造将熔融的聚醚醚酮注入多孔钛的孔隙中,再通过浓度为10%的氢氟酸腐蚀12小时,形成孔径0.05mm,孔隙率90%的多孔聚醚醚酮,利用激光熔覆方法在孔中载入钽粉,钽具有优良的生物相容性,可有效提高材料的骨结合能力。该材料的压缩屈服强度为1MPa,弹性模量为0.1GPa,适用于非受力情况下的骨修复和骨植入。
实施例2
采用直径为0.2mm的钛丝,缠绕编织成设定形状,其孔隙率为30%,通过压力铸造将熔融的聚醚醚酮注入多孔钛的孔隙中,再通过浓度为10%的氢氟酸腐蚀8小时,形成孔径0.2mm,孔隙率70%的多孔聚醚醚酮,在孔中载入羟基磷灰石浆体然后固化,羟基磷灰石具有优良的生物相容性,可促进植入体与骨形成牢固的结合。该材料的压缩屈服强度为10MPa,弹性模量为2GPa,适用于非受力情况下的骨修复和骨植入。
实施例3
采用直径为0.4mm的钛丝,缠绕编织成设定形状,其孔隙率为50%,通过压力铸造将熔融的聚醚醚酮注入多孔钛的孔隙中,再通过浓度为10%的氢氟酸腐蚀8小时,形成孔径0.4mm,孔隙率50%的多孔聚醚醚酮,其形貌如图1所示,利用包埋法在孔中载入万古霉素,万古霉素是目前临床常用的抗生素,具有抑制葡萄球菌(包括耐青霉素和耐新青霉素株)的作用,可以预防术后感染,降低植入手术失败的几率。该材料的压缩屈服强度为30MPa,弹性模量为5GPa,适用于受力载荷情况下的骨修复和骨植入。
实施例4
采用直径为1mm的钛丝,缠绕编织成设定形状,其孔隙率为70%,通过压力铸造将熔融的聚醚醚酮注入多孔钛的孔隙中,再通过浓度为10%的氢氟酸腐蚀8小时,形成孔径1mm,孔隙率30%的多孔聚醚醚酮,在孔中载入银离子,银离子具有很好的抑菌作用,可以预防术后感染,降低手术失败的几率。该材料的压缩屈服强度为60MPa,弹性模量为10GPa,适用于受力载荷情况下的骨修复和骨植入。
实施例5
采用直径为2mm的钛丝,缠绕编织成设定形状,其孔隙率为90%,通过压力铸造将熔融的聚醚醚酮注入多孔钛的孔隙中,再通过浓度为10%的氢氟酸腐蚀6小时,形成孔径2mm,孔隙率10%的多孔聚醚醚酮,该材料的压缩屈服强度为100MPa,弹性模量为18GPa,适用于受力载荷情况下的骨修复和骨植入。
实施例6
采用直径为0.5mm的铝丝,缠绕编织成设定形状,其孔隙率为60%,通过压力铸造将熔融的聚醚醚酮注入多孔钛的孔隙中,再通过浓度为10%的盐酸腐蚀6小时,形成孔径0.5mm,孔隙率40%的多孔聚醚醚酮,该材料的压缩屈服强度为40MPa,弹性模量为7GPa,适用于受力载荷情况下的骨修复和骨植入。
实施例7
采用直径为0.1mm的锆丝,缠绕编织成设定形状,其孔隙率为40%,通过压力铸造将熔融的聚醚醚酮注入多孔钛的孔隙中,再通过浓度为10%的氢氟酸腐蚀8小时,形成孔径0.1mm,孔隙率60%的多孔聚醚醚酮,该材料的压缩屈服强度为20MPa,弹性模量为4GPa,适用于受力载荷情况下的骨修复和骨植入。
Claims (8)
1.一种医用可载药多孔聚醚醚酮,其特征在于,该医用聚醚醚酮具有均匀的多孔结构或呈梯度变化多孔结构,孔径大小为0.05-2mm,孔隙率为10%-90%;
所述的多孔聚醚醚酮的抗压屈服强度范围为1MPa-120MPa,弹性模量范围为0.1GPa-20Gpa;
所载药物包括生物相容性好的物质、预防术后感染的药物、促进骨细胞生长的元素,抗肿瘤的药物或生长因子;
所述的生物相容性好的物质包括钽粉、羟基磷灰石、硅酸钙、磷酸钙或硫酸钙;
所述的预防术后感染的药物包括银离子、硫酸庆大霉素或万古霉素;
所述的促进骨细胞生长的元素包括锶、锌、锂、钙。
2.根据权利要求1所述的医用可载药多孔聚醚醚酮,其特征在于,所述的多孔聚醚醚酮孔的大小和孔隙率可根据需要调节。
3.根据权利要求1所述的医用可载药多孔聚醚醚酮,其特征在于,所述的聚醚醚酮中可根据需要添加短纤维增强相或颗粒增强相,所述的短纤维增强相选自碳纤维、氧化物晶须或生物玻璃纤维,所述的颗粒增强相选自生物玻璃颗粒、钽粉或羟基磷灰石粉。
4.一种如权利要求1所述的医用可载药多孔聚醚醚酮的制造方法,其特征在于,该方法包括以下步骤:熔融态聚醚醚酮通过压力铸造方式挤压进入预制体孔隙中,然后通过化学方法腐蚀掉预制体,形成多孔的聚醚醚酮。
5.根据权利要求4所述的医用可载药多孔聚醚醚酮的制造方法,其特征在于,所述的预制体为钛丝,锆丝,铝丝或不锈钢丝缠绕编织而成。
6.根据权利要求4或5所述的医用可载药多孔聚醚醚酮的制造方法,其特征在于,所述的预制体所用金属丝直径为0.05-2mm,预制体孔隙率为10%-90%。
7.根据权利要求4所述的医用可载药多孔聚醚醚酮的制造方法,其特征在于,所述的腐蚀掉预制体采用的化学腐蚀剂为氢氟酸、盐酸、硝酸、硫酸或王水。
8.一种如权利要求1所述的医用可载药多孔聚醚醚酮的应用,其特征在于,可根据需要在聚醚醚酮的孔中载入药物,药物通过激光熔覆、渗透法、包埋法、溶剂挥干法、熔融法或吸附平衡法载入。
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