新型组合式腰椎间融合器的研制和生物力学评价  

The design and biomechanical evaluation of a assemble interbody fusion cage

作　　者：丁金勇[1] 钱莘[2] 吴小程[1] 田华科[1] 刘涛[1] 周跃[1] 

机构地区：[1]第三军医大学附属新桥医院骨科,重庆400037 [2]武警广东总队医院肿瘤科,广州510507

出　　处：《中国临床解剖学杂志》2009年第5期588-591,共4页Chinese Journal of Clinical Anatomy

基　　金：重庆市自然科学基金(编号:2007BB5060);获得国家知识产权局专利(200720125104.0)

摘　　要：目的:介绍新型组合式腰椎间融合器的设计原理和构型,并对其进行生物力学评价。方法:采用聚醚醚酮材料研制一种具有组合式构型的腰椎椎间融合器,在新鲜小牛脊柱功能节段标本上测试正常组(完整状态)、椎间盘摘除组(不稳组)、自体植骨融合组、传统PEEK融合器组(与新型融合器材料大小形状相同)、新型PEEK融合器组合组(融合器在组合状态)、新型PEEK融合器分开组(融合器在分开状态)在前屈、后伸、左、右侧屈、左右旋转状态下的活动角度值(Range of Motion,ROM)和压缩载荷和拔出力(分别在装载植骨、未装载植骨时)。结果:(1)新型分开组与正常组、不稳组和植骨组在前屈、后伸、左右侧弯4种状态比较,P<0.05,有统计学差异;(2)与传统融合组、新型组合组相比,P>0.05,无统计学差异;(3)新型分开组左、右旋转状态与正常组和植骨组相比,P>0.05,无显著统计学意义,但与传统融合组、新型组合组相比,ROM数值增大,P<0.05,有统计学差异。(4)新型融合器分开组在未植骨和植骨时的压缩载荷值大于传统融合器组、新型融合器组合组,但无统计学差异;(5)新型融合器分开组拔出力在植骨和未植骨时均低于传统融合器组和新型融合器组合组,但无统计学差异。结论:新型组合式腰椎间融合器体外生物力学实验显示具有良好的植入运动稳定性和抗压缩载荷、抗拔出性能,能满足临床植入的生物力学要求,尤其是微创脊柱外科手术中。Objective： To design a new type of assemble lumber interbody fusion cage（AL1FCage） made of Polyetheretherketone-PEEK and to evaluate its biomechanical behavior. Methods： Twenty-four calf lumbar specimens were randomly divided into 6 groups with 4 specimens in each group, including control （intact） group, destabilized （after discectomy） group, autogenous graft （AG） group, traditional PEEK cage （T-PEEKCage）group, ALIFCage-1 group （in separate state）, and ALIFCage-2 group （in assemble state）. Specimens of all groups were tested for range of motion （ROM） under the condition of anteflexion, extension, bending laterally （left/right） and axial rotation （left/right）, axial compressing load and pull-out strength using a spinal three dimension analysis system. Results： For ROM, statistically significant difference was observed among ALIFCage-I group, intact group, destabilized group and AG group （P〈0.05） under the condition of flexion, extension, bending laterally, but no significant difference compared to that of T-PEEKCage group and AL1FCage-2 group. Under the condition of axial rotation, there was no significant difference among ALIFCage-1 group, intact group and AG group, however, significant difference existed between T-PEEKCage group and ALIFCage-2 group. For axial compressing load and pull-out strength, ALIFCage-l group increased and decreased compared to T-PEEKCage group and ALIFCage-2 group respectively, despite of no significant difference. Conclusions： The ALIFCAGE designed demonstrates good biomechanical stability of implantion, axial compressing load and pull out resistance in vitro. It can be used as a reliable lumbar interbodv fusion device in vivo, especially in the minimal invasive spine surgery.

关 键 词：椎间融合器 腰椎功能节段 生物力学 

分 类 号：R318.01[医药卫生—生物医学工程]