CN102178983A - Ha纤维增强peek脊柱融合器 - Google Patents
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Abstract
HA纤维增强PEEK脊柱融合器,其特征在于所述脊柱融合器采用PEEK材料加入HA纤维制成,所述HA纤维为直径为纳米级、长度为微米级的羟基磷灰石纤维。所述PEEK为医用植入型PEEK原料。所述HA纤维增强PEEK中含有5%-30%质量分数的HA纤维。HA纤维能够增强PEEK的强度,克服PEEK作为脊柱融合器的不足,满足脊柱融合器的力学要求,同时,本发明的HA纤维增强PEEK脊柱融合器改善了PEEK与骨的生物相容性,提高了PEEK的生物活性,利于骨的融合。
Description
技术领域
本发明属于生物医用材料领域,具体的涉及利用新材料的脊柱融合器。
背景技术
椎体间融合术作为脊柱外科的一项重要技术,己经广泛应用于脊柱骨折、脱位等情况的治疗,尤其是在退行性脊柱疾病的治疗中发挥了不可替代的作用。脊柱融合是治疗脊柱结核、感染、畸形、退行性病变以及椎间盘损伤等脊柱疾患的有效手段。
20世纪50年代,Cloward首先提出后路腰椎间融合术(posterior lumbar interbody fusion,PLIF)的概念。从生物力学看这是一种较为理想的脊柱融合术,已逐渐发展成为脊柱外科基本技术之一。1984年,DeBowes报道将不锈钢笼(cage)置入马的颈椎获得愈合。1988年,Bagby将cage按照Clowar方法用于人体颈椎间融合,并提出“撑开-压缩”原理来描述纤维环撑开后对椎间隙内cage形成压缩固定的力学机制。椎间融合器具有撑开椎间隙,使前纵韧带处于紧张状态、恢复椎间高度,并通过腹部肌肉的收缩、自身体重等对椎间融合器的压缩实现椎间融合器的稳定并促进椎体间的骨性融合,其作用主要是有效维持椎间隙的高度并稳定融合节段,从而实现椎间的骨性融合。同年,Kuslich与Bagby合作,采用钛合金制成cage用于腰椎间融合,命名为BAK(Bagby And Kuslich,BAK)。1989年Bay设计出金属螺纹融合支架TFC(threaded fusion cage,TFC)BAK,TFC成为腰椎间融合器的早期代表。脊柱椎间融合器能够通过椎体周围肌肉收缩和椎体周围韧带张力作用而保持每个融合节段的稳定性,随着临床及生物力学研究以及材料学的发展和外形设计的进步,为融合节段的稳定性提供了更多的保证。cage从早期的螺纹式圆柱体形,发展出长方体、椭圆形和网状等多种形态。应用cage治疗腰椎疾患只有短短的一二十年的时间,但它在生物力学方面的优越性越来越受到关注,新的设计理念不断引入,技术、材料日益改进,更新,呈现较快的发展。
目前临床上应用的融合器主要由钛合金和高分子PEEK材料制成,然而在使用中两种材料都存在不同程度的问题。
金属脊柱融合器的弹性模量远远高于皮质骨,在体内会引起应力遮挡,从而导致植入部位产生骨质疏松、骨萎缩、植入部位塌陷、融合器松动或滑脱等并发症。金属材料无法透过X光,影响术后对骨融合部位的观察。
由人工合成的高分子材料制成的脊柱融合器(如聚醚醚酮,PEEK),虽然弹性模量与推体骨匹配,具有良好的抗腐蚀性,能透过X光,但同时也可导致一系列并发症:神经根损伤;融合器松动;融合器塌陷,椎间隙及椎间孔高度减小;不融合等。
羟基磷灰石是一种磷酸钙即Hydroxyapatite(HA),广泛存在于人体中,主要分布于骨骼和牙齿中,因此其生物相容性很好。羟基磷灰石实质上是一种高度交错聚合的陶瓷磷酸钙聚合物,其中钙磷元素摩尔比值为1.67。在骨骼和牙齿中,钙和磷主要以胶体磷酸钙结晶形态存在,并和胶原蛋白质共同构成复杂的网络结构。羟基磷灰石能与胶原蛋白和细胞紧密结合,促进骨骼的生长,在硬和软组织的连接中起到关键的作用。有研究表明,植入的羟基磷灰石材料在缺损处为修复早期的微血管形成及宿主骨系细胞的附着提供支撑。但常规羟基磷灰石陶瓷是脆性材料,仅能用于人工关节涂层,听耳骨等非承重条件下的生物材料应用。
发明内容
为克服以上不足,本发明提供HA纤维增强的PEEK制成的脊柱融合器。
HA纤维增强PEEK脊柱融合器,其特征在于所述脊柱融合器采用PEEK材料加入HA纤维制成,所述HA纤维为直径为纳米级、长度为微米级的羟基磷灰石纤维。
所述PEEK为医用植入型PEEK原料。
所述HA纤维增强PEEK中含有5%-30%质量分数的HA纤维。
所述HA纤维经分散和偶合处理。
所述HA纤维与PEEK混合注塑成型。
所述脊柱融合器为用于椎间盘的脊柱融合器,用于颈椎的矩形立方体脊柱融合器或用于腰椎的棋形立方体脊柱融合器。
技术效果:
应用HA纤维增强PEEK材料制成脊柱融合器中,不仅克服了金属材料脊柱融合器的诸多缺点,也可有效克服PEEK和HA本身的不足。
本发明采用HA纤维增强PEEK注塑成型制成的脊柱融合器,既避免了金属融合器所存在的应力遮挡和金属碎屑问题,且兼容CT和MRI检查。
用特殊工艺将HA制成直径为纳米级,长度为微米级的纤维,可大大改善HA的机械性能。PEEK中加少量HA纤维,利用HA纤维的高强度、硬度和纤维的独特性能可改进PEEK原有的性能,同时保证PEEK与骨匹配的弹性模量,植入体内后,HA还可与骨有良好的融合性。
本发明将HA纤维增强PEEK应用于脊柱融合器,能够增强PEEK的强度,能够克服PEEK作为脊柱融合器的不足,满足脊柱融合器的力学要求,同时,本发明的HA纤维增强PEEK脊柱融合器改善了PEEK与骨的生物相容性,在体内与骨达到骨性融合。
具体实施方式
下面结合具体实施例对本发明作进一步的说明。
实施例1
脊柱融合器为长方香蕉型,宽14mm,长25mm,高10mm,壁厚2.5mm,上下表面具有解剖型结构,其上的咬合齿高度为0.5mm。适用于患者L5/S1椎间盘突出症。
HA纤维增强PEEK脊柱融合器,脊柱融合器所用材料为德国EVONIK公司进口的医用植入型PEEK材料。HA纤维为直径纳米级、长度微米级的自制羟基磷灰石纤维。HA纤维加入量为20%。
实施例2
脊柱融合器的结构尺寸同实施例1。但融合器有前低后高5度的倾斜度。宽14mm,长25mm,高10mm,壁厚2.5mm,上下表面具有解剖型结构,其上的咬合齿高度为0.5mm。
HA纤维增强PEEK脊柱融合器,脊柱融合器所用材料为德国EVONIK公司进口的医用植入型PEEK材料。HA纤维的直径为纳米级,长度为微米级的自制羟基磷灰石纤维,经分散和偶合处理。HA纤维加入量为20%。适用于患者L4/L5椎间盘突出症。
实施例3
HA纤维增强PEEK脊柱融合器,脊柱融合器所用材料为德国EVONIK公司进口的医用植入型PEEK材料。HA纤维的直径为纳米级,长度为微米级的自制羟基磷灰石纤维,经分散和偶合处理。HA纤维加入量为30%。适用于患者L5/S1椎间盘突出症。
实施例4
HA纤维增强PEEK脊柱融合器,脊柱融合器所用材料为德国EVONIK公司进口的医用植入型PEEK材料。HA纤维的直径为纳米级,长度为微米级的自制羟基磷灰石纤维。HA纤维加入量为10%。
实施例5
HA纤维增强PEEK脊柱融合器,脊柱融合器所用材料为德国EVONIK公司进口的医用植入型PEEK材料。HA纤维的直径为纳米级,长度为微米级的自制羟基磷灰石纤维。HA纤维加入量为5%。
实施例6
HA纤维增强PEEK脊柱融合器,脊柱融合器所用材料为德国EVONIK公司进口的医用植入型PEEK材料。HA纤维的直径为纳米级,长度为微米级的自制羟基磷灰石纤维。HA纤维加入量为25%。
其它实施例
本发明的脊柱融合器具有各种不同的设计型式和尺寸,以适应不同的患者及不同的脊往受损部位。
还包括适用于颈椎的矩形立方体脊柱融合器,宽13mm,长13mm,高7mm。
还包括适用于腰椎的棋形立方体脊柱融合器,宽25mm,长13mm,高13mm,等等。
以上各实施例的弯曲强度在160MPa左右,弹性模量在106Pa左右。成年人骨的弯曲强度为160Mpa,弹性模量在18Gpa左右,这说明HA纤维增强的PEEK材料在力学强度上还是比较符合人体骨的力学标准的。
各实施例证明为提高医用植入级PEEK机械性能和生物相容性,在PEEK中添加总质量为5%-30%的HA纤维是有效的。掺杂5%、10%、15%、20%、30%,它们都能不同程度的提高PEEK的硬度和强度,对生物相容性也有不同程度的改善.
为使HA纤维能更好地均匀分散,并更加牢固地与PEEK结合,HA纤维与PEEK混合前应做分散处理和偶合处理。HA纤维增强PEEK脊柱融合器能够增强PEEK的强度,克服PEEK作为脊柱融合器的不足,满足脊柱融合器的力学要求,同时,本发明的HA纤维增强PEEK脊柱融合器改善了PEEK与骨的生物相容性,提高了PEEK的生物活性,利于骨的融合。
Claims (6)
1.HA纤维增强PEEK脊柱融合器,其特征在于所述脊柱融合器采用PEEK材料加入HA纤维制成,所述HA纤维为直径为纳米级、长度为微米级的羟基磷灰石纤维。
2.根据权利要求1所述的HA纤维增强PEEK脊柱融合器,其特征在于所述PEEK为医用植入型PEEK原料。
3.根据权利要求1所述的HA纤维增强PEEK脊柱融合器,其特征在于所述所述HA纤维质量分数为5%-30%。
4.根据权利要求1所述的HA纤维增强PEEK脊柱融合器,其特征在于所述HA纤维经分散和偶合处理。
5.根据权利要求1所述的HA纤维增强PEEK脊柱融合器,其特征在于所述HA纤维与PEEK混合注塑成型。
6.根据权利要求1-5任一所述的脊柱融合器,其特征在于所述脊柱融合器为用于椎间盘的脊柱融合器,用于颈椎的矩形立方体脊柱融合器或用于腰椎的棋形立方体脊柱融合器。
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Cited By (2)
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CN102602000A (zh) * | 2012-03-02 | 2012-07-25 | 北京奥精医药科技有限公司 | 一种植入级peek冷压烧结成型方法及脊柱融合器 |
WO2015184696A1 (zh) * | 2014-06-03 | 2015-12-10 | 深圳兰度生物材料有限公司 | 人工椎间盘及其制备方法 |
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CN102602000A (zh) * | 2012-03-02 | 2012-07-25 | 北京奥精医药科技有限公司 | 一种植入级peek冷压烧结成型方法及脊柱融合器 |
CN102602000B (zh) * | 2012-03-02 | 2014-07-30 | 北京奥精医药科技有限公司 | 一种植入级peek冷压烧结成型方法及脊柱融合器 |
WO2015184696A1 (zh) * | 2014-06-03 | 2015-12-10 | 深圳兰度生物材料有限公司 | 人工椎间盘及其制备方法 |
CN105147420A (zh) * | 2014-06-03 | 2015-12-16 | 深圳兰度生物材料有限公司 | 人工椎间盘及其制备方法 |
CN105147420B (zh) * | 2014-06-03 | 2017-07-28 | 深圳兰度生物材料有限公司 | 人工椎间盘及其制备方法 |
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