带预警装置的椎弓根螺锥的研制与实验研究
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摘要
目的:研制一种带预警装置的椎弓根螺锥,在胸腰椎(T_8～L_5)椎弓根系统内固定钉道准备过程中,螺锥误入椎管或穿透椎骨之前可提供实时自动报警,提示术者改变方向,避免损伤重要神经、血管。
方法:研制一种带预警装置的椎弓根螺锥(简称预警螺锥),在椎弓根系统内固定钉道准备过程中,在压力达到报警阈值时,可立即发出声音、灯光双重警报。报警阈值研究:阈值的设定条件为大于在椎骨(T_8～L_5)内部的最大压力最大值,小于穿破椎骨皮质时的最大压力的最小值。首先测定预警螺锥在椎骨内的最大压力,然后测定预警螺锥突破椎弓根上、下、内、外侧皮质,椎体前侧及两侧皮质时的最大压力。选取8具正常成人尸体,取胸腰椎(T_8～L_5)脊柱标本,随机平均分为4组。第1组测试预警螺锥在椎骨内部的最大压力,第2组测试预警螺锥突破椎体前方皮质时的最大压力,第3组测试预警螺锥穿透上下终板、椎弓根上下切迹时的最大压力,第4组测试预警螺锥穿透椎弓根内外侧皮质及椎体侧方皮质时的最大压力。将数据通过SPSS13.0软件进行统计学分析,设定预警螺锥的报警阈值。测试报警效应:取4具正常成人尸体,俯卧位,后正中切口,将预警螺锥设定为报警阈值,利用预警螺锥在胸腰椎(T_8～L_5)按常规椎弓根系统手术准备椎弓根螺钉钉道,术中一旦预警螺锥报警即停止进针,记录每个椎骨的报警结果。术后将每个椎骨沿钉道剖开,直视下观察钉道与椎骨皮质的关系,利用统计学分析预警螺锥的报警效应。
结果:在预警螺锥压力测试中,经统计学分析,突破椎骨内部的最大压力与突破椎骨各部分皮质时的最大压力有非常显著性差异,P＜0.01。经统计学分析后,测得报警阈值为9.6～12.3千克力。在测试螺锥的报警效应中,测得预警螺锥的诊断效率为92.5%,灵敏度为92.31%,特异度为95.12%,可用度为87.45%,Youden指数为87.43%,均达到了满意的效果。
结论:在体外实验中,预警螺锥在胸腰椎(T_8～L_5)椎弓根螺钉钉道准备过程中,具有良好的报警效应,可作为传统椎弓根系统手术中的辅助器械。
Objective To design a pedicle piercer with early warning device which can provide real time auto alarm before the piercer would penetrate through vertebral body on the pedicle screw system of T_8～L_5.It can prompt surgeon to change drilling direction,and avoid damaging important nerves and blood vessel.
Methods A pedicle piercer with early warning device(Pedicle-guide to call for short) was designed,which could warn by sound and light at once when the pressure increased stress at the threshold.Study of the threshold:The condition of the threshold was what the maximum pressure in the vertebral bodies was greater than the maximum pressure when Pedicle-guide penetrated through cortical bone.Maximum pressure was measured when the Pedicle-guide penetrated through cortical bone and cancellous bone of T_8～L_5.Eight thoracolumbar(T_8～L_5) spine specimens of normal adult body were randomly divided into 4 groups.Group 1,the maximum pressure was tested when Pedicle-guide penetrated through cancellous bone of vertebrae.Group 2,the maximum pressure was tested when Pedicle-guide penetrated through anterior vertebral cortical.Group 3,the maximum pressure was tested when Pedicle-guide penetrated through vertebral cortical of lamina terminalis and vertebral notch.Group 4, maximum pressure was tested when Pedicle-guide penetrated through the lateral vertebral cortex of vertebrae and pedicle.The threshold was set after statistical analysis.The effect of warning:Four spine specimens were choosen,included T_8～L_5,eighty vertebrae.The entry site for each pedicle was identified using anatomic landmarks based on estimation of the pedicle projection dorsally,our routine method in clinical practice.The screw channel was prepared with Pedicle-guide,the result of everyone was recorded.The screw channel was dissected,and the position between screw channel and cortex of vertebrae was compared.The effect of warning was analysis by using statistics.
Results There was significant difference between the maximum pressure in the vertebral bodies and the maximum pressure when Pedicle-guide penetrated through cortical bone (P＜0.01).The threshold is 9.6～12.3kgN after statistical analysis.In the testing of the effect of warning,diagnostic effciency was 92.5%,senstivity was 92.31%,specificity was 95.12%,diagnostic availabiity was 87.45%,Youden index was 87.43%.The results was satisfactory.
Conclusion The results of this in vitro study suggest the Pedicle-guide can sound the alarm and light immediately on pedicle screw fixation of T_8～L_8.It can be used as auxiliary surgical instruments on the operation of traditional pedicle screw fixation.
方法:研制一种带预警装置的椎弓根螺锥(简称预警螺锥),在椎弓根系统内固定钉道准备过程中,在压力达到报警阈值时,可立即发出声音、灯光双重警报。报警阈值研究:阈值的设定条件为大于在椎骨(T_8～L_5)内部的最大压力最大值,小于穿破椎骨皮质时的最大压力的最小值。首先测定预警螺锥在椎骨内的最大压力,然后测定预警螺锥突破椎弓根上、下、内、外侧皮质,椎体前侧及两侧皮质时的最大压力。选取8具正常成人尸体,取胸腰椎(T_8～L_5)脊柱标本,随机平均分为4组。第1组测试预警螺锥在椎骨内部的最大压力,第2组测试预警螺锥突破椎体前方皮质时的最大压力,第3组测试预警螺锥穿透上下终板、椎弓根上下切迹时的最大压力,第4组测试预警螺锥穿透椎弓根内外侧皮质及椎体侧方皮质时的最大压力。将数据通过SPSS13.0软件进行统计学分析,设定预警螺锥的报警阈值。测试报警效应:取4具正常成人尸体,俯卧位,后正中切口,将预警螺锥设定为报警阈值,利用预警螺锥在胸腰椎(T_8～L_5)按常规椎弓根系统手术准备椎弓根螺钉钉道,术中一旦预警螺锥报警即停止进针,记录每个椎骨的报警结果。术后将每个椎骨沿钉道剖开,直视下观察钉道与椎骨皮质的关系,利用统计学分析预警螺锥的报警效应。
结果:在预警螺锥压力测试中,经统计学分析,突破椎骨内部的最大压力与突破椎骨各部分皮质时的最大压力有非常显著性差异,P＜0.01。经统计学分析后,测得报警阈值为9.6～12.3千克力。在测试螺锥的报警效应中,测得预警螺锥的诊断效率为92.5%,灵敏度为92.31%,特异度为95.12%,可用度为87.45%,Youden指数为87.43%,均达到了满意的效果。
结论:在体外实验中,预警螺锥在胸腰椎(T_8～L_5)椎弓根螺钉钉道准备过程中,具有良好的报警效应,可作为传统椎弓根系统手术中的辅助器械。
Objective To design a pedicle piercer with early warning device which can provide real time auto alarm before the piercer would penetrate through vertebral body on the pedicle screw system of T_8～L_5.It can prompt surgeon to change drilling direction,and avoid damaging important nerves and blood vessel.
Methods A pedicle piercer with early warning device(Pedicle-guide to call for short) was designed,which could warn by sound and light at once when the pressure increased stress at the threshold.Study of the threshold:The condition of the threshold was what the maximum pressure in the vertebral bodies was greater than the maximum pressure when Pedicle-guide penetrated through cortical bone.Maximum pressure was measured when the Pedicle-guide penetrated through cortical bone and cancellous bone of T_8～L_5.Eight thoracolumbar(T_8～L_5) spine specimens of normal adult body were randomly divided into 4 groups.Group 1,the maximum pressure was tested when Pedicle-guide penetrated through cancellous bone of vertebrae.Group 2,the maximum pressure was tested when Pedicle-guide penetrated through anterior vertebral cortical.Group 3,the maximum pressure was tested when Pedicle-guide penetrated through vertebral cortical of lamina terminalis and vertebral notch.Group 4, maximum pressure was tested when Pedicle-guide penetrated through the lateral vertebral cortex of vertebrae and pedicle.The threshold was set after statistical analysis.The effect of warning:Four spine specimens were choosen,included T_8～L_5,eighty vertebrae.The entry site for each pedicle was identified using anatomic landmarks based on estimation of the pedicle projection dorsally,our routine method in clinical practice.The screw channel was prepared with Pedicle-guide,the result of everyone was recorded.The screw channel was dissected,and the position between screw channel and cortex of vertebrae was compared.The effect of warning was analysis by using statistics.
Results There was significant difference between the maximum pressure in the vertebral bodies and the maximum pressure when Pedicle-guide penetrated through cortical bone (P＜0.01).The threshold is 9.6～12.3kgN after statistical analysis.In the testing of the effect of warning,diagnostic effciency was 92.5%,senstivity was 92.31%,specificity was 95.12%,diagnostic availabiity was 87.45%,Youden index was 87.43%.The results was satisfactory.
Conclusion The results of this in vitro study suggest the Pedicle-guide can sound the alarm and light immediately on pedicle screw fixation of T_8～L_8.It can be used as auxiliary surgical instruments on the operation of traditional pedicle screw fixation.
引文
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