开放式记忆合金人工椎体的研制和生物力学分析
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摘要
目的：设计一种开放式记忆合金人工椎体,可用于胸腰椎肿瘤、爆裂性骨折、侧弯、后凸畸形等脊柱疾患手术切除病变椎体后脊柱结构的重建,且可使手术变得简便、安全,并对其进行生物力学分析。
方法：课题分为两部分：(1)开放式记忆合金人工椎体的研制：依据胸腰椎的解剖特点,研究正常国人腰椎脊髓神经根窗的高度,提出国人腰椎人工椎体的规格数据,研制出开放式记忆合金人工椎体。(2)开放式记忆合金人工椎体的生物力学分析：选取正常成年新鲜猪脊柱标本胸14-腰5(猪胸椎有15个)8具。每个标本制作4种状态的实验模型：完整椎体模型,行T15、L1、L3、L4椎弓根钉固定模型,记忆合金人工椎体重建L2椎体+T15、L1、L3、L4椎弓根钉固定模型,钛网重建L2椎体+T15、L1、L3、L4椎弓根钉固定模型。在美国MTS-858脊柱三维运动实验机上先依次完成完整椎体模型和椎弓根钉固定模型的三维活动范围(ROM)测试,再轮替进行记忆合金人工椎体置换模型和钛网置换模型的制作,进行脊柱稳定性测试。将计算机采集的数据应用SPSS13.0软件进行自身交叉设计实验的方差分析。
结果：(1)开放式记忆合金人工椎体的形状记忆效应使其在冰水中可压缩体积通过相应的脊髓神经根窗,复温后可产生可靠的回复力,撑开恢复椎节的高度,因此记忆合金人工椎体可从后路植入椎体间,且操作简便。(2)与完整椎体模型相比,单纯椎弓根固定模型、记忆合金人工椎体置换模型和钛网置换模型各节段的前屈、后伸、左右侧弯、左右旋转活动范围均较小,稳定性好,有统计学差异(P<0.05),其中,在L1-L3节段记忆合金人工椎体置换模型前屈、后伸、左侧弯、右侧弯、左旋、右旋活动范围分别为完整椎体模型的11%、10%、6%、6%、15%、15%。与单纯行椎弓根固定模型相比,记忆合金人工椎体置换模型在各方向的活动度无统计学差异(P>0.05)。与钛网置换模型相比,记忆合金人工椎体置换模型在T15-L1及L3-L4节段的前屈、后伸、左右侧弯、左右旋转的活动范围较小,有统计学差异(P<0.05)；在L1-L3节段各方向活动范围无明显统计学差异(P>0.05)。
结论：开放式记忆合金人工椎体结构设计符合脊柱内固定器械设计的原理,具有创新性,生物力学性能良好。开放式记忆合金人工椎体能恢复椎节的高度,与钛网置换模型具有相近的术后即刻稳定性,在附加椎弓根钉固定的情况下能重建脊柱的即刻稳定。其对相邻节段影响较小,有助于减小应力集中,降低内固定失败的几率。研究结果为下一步的动物实验和初期临床应用提供了生物力学基础。
Objective To design an open shape memory alloy artificial vertebral body that can be used to reconstrut the vertebral body in spine diseases,such as thoracolumbar spine tumors, burst fracture of the vertebral,kyphotic and scoliosis.And to evaluate the biomechanical stability of lumbar functional segment unit after insertion with the shape memory alloy artificial vertebral body.
Methods The research divided into two parts,(1)The development of open shape memory alloy artificial vertebral body:We collected the height of lumbar roots in normal people and according to the spine data,we made sure the size of the artificial vertebral body.Finally, we made the open nickel-titanium shape memory alloy artificial vertebral body. (2) The biomechanical analysis of open shape memory alloy artificial vertebral body:Eight normal adult fresh porcine spine specimens(thoracic 14-lumbar 5) (the pig has 15 thoracic vertebrae) was used to detect the range of motion(ROM) in four models,which were intact vertebral model, pedicle screw fixation inT15, L1, L3and L4 model, L2 total resection and reconstructed by open shape memory alloy artificial vertebral body model, lumbar 2 total resection and reconstructed by titanium mesh vertebral body model. The last two models were made by turns. All models were tested using a spinal three dimensional anlysis system (tipe:U.S. MTS-858).Undertake the data with medical statistical analysls.
Results (1)The open shape memory alloy artificial vertebral body can be putted through the lumbar roots windows when be compressed in the ice water.Then when temperature rised,the elastic recovered to revive the height of the spine.So the open shape memory alloy artificial vertebral body made the operation easily. (2)Compared with the intact vertebral body model, the other three models were more stable in compression,flexion, left and right lateral bending, and rotation,there was significant difference(P0.05).Compared with the titanium mesh reconstructed model, the memory alloy artificial vertebral body reconstructed model had less degree of motion in T15-L1 and L3-L4 segments(P<0.05),but no statistic significance in L1-L3 segment.
Conclusion The design of the open shape memory alloy artificial vertebral body meets the design principles.It is innovative and has a good biomechanical stability. It can be used to recover the height and stabilize the spinal segment with pedicle screw fixation.And there is less effective in the adjacent segments. It can help to reduce the stress concentration. So it can reduce the probability of failure.This study offers the bio-mechanical basis to the next phase of animal experiments and initial clinical application.
方法：课题分为两部分：(1)开放式记忆合金人工椎体的研制：依据胸腰椎的解剖特点,研究正常国人腰椎脊髓神经根窗的高度,提出国人腰椎人工椎体的规格数据,研制出开放式记忆合金人工椎体。(2)开放式记忆合金人工椎体的生物力学分析：选取正常成年新鲜猪脊柱标本胸14-腰5(猪胸椎有15个)8具。每个标本制作4种状态的实验模型：完整椎体模型,行T15、L1、L3、L4椎弓根钉固定模型,记忆合金人工椎体重建L2椎体+T15、L1、L3、L4椎弓根钉固定模型,钛网重建L2椎体+T15、L1、L3、L4椎弓根钉固定模型。在美国MTS-858脊柱三维运动实验机上先依次完成完整椎体模型和椎弓根钉固定模型的三维活动范围(ROM)测试,再轮替进行记忆合金人工椎体置换模型和钛网置换模型的制作,进行脊柱稳定性测试。将计算机采集的数据应用SPSS13.0软件进行自身交叉设计实验的方差分析。
结果：(1)开放式记忆合金人工椎体的形状记忆效应使其在冰水中可压缩体积通过相应的脊髓神经根窗,复温后可产生可靠的回复力,撑开恢复椎节的高度,因此记忆合金人工椎体可从后路植入椎体间,且操作简便。(2)与完整椎体模型相比,单纯椎弓根固定模型、记忆合金人工椎体置换模型和钛网置换模型各节段的前屈、后伸、左右侧弯、左右旋转活动范围均较小,稳定性好,有统计学差异(P<0.05),其中,在L1-L3节段记忆合金人工椎体置换模型前屈、后伸、左侧弯、右侧弯、左旋、右旋活动范围分别为完整椎体模型的11%、10%、6%、6%、15%、15%。与单纯行椎弓根固定模型相比,记忆合金人工椎体置换模型在各方向的活动度无统计学差异(P>0.05)。与钛网置换模型相比,记忆合金人工椎体置换模型在T15-L1及L3-L4节段的前屈、后伸、左右侧弯、左右旋转的活动范围较小,有统计学差异(P<0.05)；在L1-L3节段各方向活动范围无明显统计学差异(P>0.05)。
结论：开放式记忆合金人工椎体结构设计符合脊柱内固定器械设计的原理,具有创新性,生物力学性能良好。开放式记忆合金人工椎体能恢复椎节的高度,与钛网置换模型具有相近的术后即刻稳定性,在附加椎弓根钉固定的情况下能重建脊柱的即刻稳定。其对相邻节段影响较小,有助于减小应力集中,降低内固定失败的几率。研究结果为下一步的动物实验和初期临床应用提供了生物力学基础。
Objective To design an open shape memory alloy artificial vertebral body that can be used to reconstrut the vertebral body in spine diseases,such as thoracolumbar spine tumors, burst fracture of the vertebral,kyphotic and scoliosis.And to evaluate the biomechanical stability of lumbar functional segment unit after insertion with the shape memory alloy artificial vertebral body.
Methods The research divided into two parts,(1)The development of open shape memory alloy artificial vertebral body:We collected the height of lumbar roots in normal people and according to the spine data,we made sure the size of the artificial vertebral body.Finally, we made the open nickel-titanium shape memory alloy artificial vertebral body. (2) The biomechanical analysis of open shape memory alloy artificial vertebral body:Eight normal adult fresh porcine spine specimens(thoracic 14-lumbar 5) (the pig has 15 thoracic vertebrae) was used to detect the range of motion(ROM) in four models,which were intact vertebral model, pedicle screw fixation inT15, L1, L3and L4 model, L2 total resection and reconstructed by open shape memory alloy artificial vertebral body model, lumbar 2 total resection and reconstructed by titanium mesh vertebral body model. The last two models were made by turns. All models were tested using a spinal three dimensional anlysis system (tipe:U.S. MTS-858).Undertake the data with medical statistical analysls.
Results (1)The open shape memory alloy artificial vertebral body can be putted through the lumbar roots windows when be compressed in the ice water.Then when temperature rised,the elastic recovered to revive the height of the spine.So the open shape memory alloy artificial vertebral body made the operation easily. (2)Compared with the intact vertebral body model, the other three models were more stable in compression,flexion, left and right lateral bending, and rotation,there was significant difference(P
Conclusion The design of the open shape memory alloy artificial vertebral body meets the design principles.It is innovative and has a good biomechanical stability. It can be used to recover the height and stabilize the spinal segment with pedicle screw fixation.And there is less effective in the adjacent segments. It can help to reduce the stress concentration. So it can reduce the probability of failure.This study offers the bio-mechanical basis to the next phase of animal experiments and initial clinical application.
引文
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