首页 > 资料专栏 > 经贸 > 商贸 > 商贸可研 > 经椎弓根定位骶髂螺钉导向器的研制及可行性研究报告

经椎弓根定位骶髂螺钉导向器的研制及可行性研究报告

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目的:本课题尝试通过对 S1 椎弓根与侧块特殊解剖关系的研究,探索经椎弓根定 位引导螺钉置入的可行性、安全性;设计并应用导向器置钉,为其应用于临床提供实验 依据和理论基础。 方法:1、对正常成人骨盆 100 例(男女各 50 例)进行 CT 影像学测量:(1)、常规 测量:①S1 横、矢状径;②S1 前、后缘高;③水平、冠状面侧块最窄处宽度;④矢状 面骶髂通道最窄处面积;⑤水平面骶髂通道轴线长度;⑥S1 中心点与外侧定位点间距离。 (2)、分别测量当定位于 S1 椎体中心和外侧点时:①水平面最大、最小进钉角度;② 冠状面最大、最小进钉角度;③水平、冠状面进钉角度范围;④水平、冠状面轴线角度。 2、分析数据并制作导向器,应用导向器在 AO 标准模拟骨盆上(5 具干骨盆,10 例骶 髂关节)进行模拟置钉。 结果:1、(1)、“S1 横、矢状径”,“S1 前、后缘高”,“水平面侧块最窄处宽度”, “矢状面通道最窄处面积”男女之间差异具有统计学意义,且男性均数大于女性。说明 男性 S1 椎体体积大于女性,男性骶髂通道较女性大。(2)、男、女性置钉安全角度测量 数据一致,差异无统计学意义;(3)、定位于 S1 外侧点所测各项指测均大于定位于 S1 中心点时所测指标。定位于 S1 外侧点,根据以 S1 椎体中心为定位点所测安全范围进钉, 安全、可靠。(4)、男性标本中:水平面上最大进针角度为:93.65°7.73°,最小为: 76.71°4.60°,具有 16.93°6.14°安全置钉范围;冠状面上最大进针角度为:92.16 °6.84°,最小为:65.05°3.80°,具有 27.11°7.18°安全置钉范围。女性标本中: 水平面上最大进针角度为:95.69°4.98°,最小为:78.09°3.72°,具有 17.60°2.74 °安全置钉范围;冠状面上最大进针角度为:94.24°5.05°,最小为:65.96°4.74 °,具有 28.28°6.12°安全置钉范围。2、根据测量数据制作导向器,并运用导向器对 10 例骶髂关节成功置入螺钉。10 枚螺钉位置良好,无螺钉位置不当或是置钉失败。 结论:经椎弓根定位引导螺钉置入安全、可行。经导向器置钉操作简便、透视少, 其适应、禁忌症与传统置钉方式基本一致。对于传统置钉方式不适合的骶骨侧块下倾角2 较大者,或是骶髂通道过于狭窄者,若在空间上允许骶髂螺钉的置入,均可应用导向器 置钉。该导向器尚未正式应用于临床,具体应用经验有待于后期研究中进一步积累、补 充。 关键词 骶髂关节,导向器,骶髂螺钉,安全区3 The feasibility analysis of sacroiliac screw director through pedicle orientation ABSTRACT Objective: To explore feasibility of screw placement by the pedicle positioning through the special anatomical relationship between S1 pedicle and lateral mass, provide experimental evidence and theoretical basis for the application of screw placement by the pedicle positioner. Methods: 1、100 normal adult pelvises (male and female were 50 cases each) were measured by CT imaging. (1) Conventional measurement: ①the S1 transverse and sagittal diameter; ②t he height of S1 front and rear edge; ③the width of the narrowest point in the horizontal and coronal plane; ④the area of the narrowest sacroiliac channel in the sagittal plane; ⑤ the length of sacroiliac channel axis in the horizontal plane; ⑥the distance between the center of S1 and lateral positioning point. (2) When positioning at the center and lateral point of S1, ① the maximum and minimum nail-entry angle in the horizontal plane; ②the maximum and minimum nail-entry angle in the coronal plane; ③ the range of nail-entry angle in the horizontal and coronal plane; ④t he angle of axis in the horizontal and coronal plane. 2、 The director, designed by data analysis, was used to place pedicle screw in the AO standard analog pelvis (5 dry pelvises and 10 cases of sacroiliac joint). Results: 1 (1) There were significant differences between men and women in the S1 transverse and sagittal diameter, the height of S1 front and rear edge, “the width of the narrowest point in the horizontal plane”, and the area of the narrowest sacroiliac channel in the sagittal plane. The mean of males were larger than females, indicating the S1 volume and sacroiliac channels of males were larger than females; (2) there was no significant difference between safe angle of screw placement; (3) the measured indicators in the lateral point of S1 were greater than in the center point of S1. The nail-entry range was safe and reliable to locate in the S1 lateral point, according to the positioning of S1 vertebral center point; (4)In the male specimens: the needle angle in the horizontal plane, maximum: 93.65° ± 7.73°, minimum:4 76.71° ± 4.60°, with a safe range of 16.93° ± 6.14° for pedicle screw placement; the needle angle in the coronal plane, maximum: 92.16° ± 6.84°, minimum: 65.05 ° ± 3.80°, with a safe range of 27.11° ± 7.18° for pedicle screw placement. Female specimens: the needle angle in the horizontal plane, maximum: 95.69 ° ± 4.98 °, minimum: 78.09° ± 3.72°, with a safe range of 17.60° ± 2.74° for pedicle screw placement; the needle angle in the coronal plane, maximum: 94.24° ± 5.05°, minimum: 65.96° ± 4.74°, with a safe range of 28.28° ± 6.12° for pedicle screw placement. 2, The director, designed by data analysis, was successfully used to place pedicle screw in 10 cases of sacroiliac joint, no screws were poorly located, or fail. Conclusion: The screw placement by the pedicle positioning was safe and feasible. It was simple to place pedicle screw by director, and the indications and contraindications were the same as traditional pedicle screw way. The director could be used to patients unsuitable for traditional pedicle screw, such as greater next angle of sacrum lateral mass, narrow sacroiliac channel, if there was enough space for screws. The director has not yet formally applied to the clinical, and the specific application experience needs to be further accumulated in the late-stage study. Keyword: Sacroiliac joint , Aiming device ,Sacroiliac screw ,Safe zone5 符号说明 L5:(the 5th Lumbar)第 5 腰椎 S1:(the 1st Sacral)第 1 骶椎 S2:(the 2nd Sacral)第 2 骶椎 ICD:(iliac cortical density)髂骨皮质致密区 H-:(in the Horizontal plane)在水平面上 C-:(in the Coronal plane)在冠状面上 S-:(in the Sigittal plane)在矢状面上 ASZ:(the Angle in the Safe Zone)骶髂通道中的进钉角度,单位:°。 maxASZ:最大进钉角度,单位:°。 minASZ:最小进钉角度,单位:°。 ranASZ:进钉角度范围,单位:°。 midASZ:轴线(居中)进钉角度,单位:°。 H-宽:水平面骶髂通道最窄处宽度,单位:㎜。 C-宽:冠状面骶髂通道最窄处宽度,单位:㎜。 S-面积:矢状面骶髂通道最窄处面积,单位:㎜^2。 C-轴长:水平面骶髂通道轴线长度,单位:㎜。6 目录 摘要 ................................................................................................................................................................ 1 符号说明......................................................................................................................................................... 1 目录 ................................................................................................................................................................ 1 前言 ................................................................................................................................................................ 1 1.骶髂螺钉是骨盆后环固定的优越方法.............................................................................................. 1 2.骶髂螺钉植入的技术难点与现状...................................................................................................... 1 3.发展趋势.............................................................................................................................................. 2 4.拟解决的问题及方案.......................................................................................................................... 3 材料与方法..................................................................................................................................................... 4 1.实验材料.............................................................................................................................................. 4 2.实验方法.............................................................................................................................................. 4 2.1 CT 测量部分............................................................................................................................. 4 2.2 制作导向器.............................................................................................................................. 8 结果 ................................................................................................................................................................ 9 1.CT 测量数据结果................................................................................................................................ 9 1.1 对 T1、T2 数据分别进行统计学描述,结果均以均数标准差(xs)表示 ....................... 9 1.2 组间、组内配对 t 检验结果................................................................................................. 10 2.导向器的制作及操作过程................................................................................................................ 12 2.1 设计示意图............................................................................................................................ 13 2.2 导向器实物图........................................................................................................................ 14 2.3 导向器操作流程.................................................................................................................... 15 2.4 应用导向器在 AO 标准模拟骨盆上进行模拟置钉 .......................................................... 190 讨论 ............................................................................................................................................................ 201 1.传统置钉方式存在明显不足.......................................................................................................... 201 1.1 骶髂螺钉进钉点的选择,观点众多,每一种方法均存在其优点与不足 ...................... 2017 1.2 进钉角度操作性差,且角度失真,医源性损伤多,学习曲线冗长 .............................. 223 2. 影像学研究证明:经椎弓根定位引导骶髂螺钉置入是安全、可行的 .................................... 224 2.1 男、女骨盆后环解剖具有一定差异 .................................................................................. 234 2.2 当定位于 S1 椎体中心时,骶髂螺钉置入的安全范围.................................................... 245 2.3 当定位于 S1 椎体外侧时,骶髂螺钉置入安全范围增大................................................ 257 3. 运用导向器使骶髂螺钉置入安全、简便.................................................................................... 268 4. 特殊病例报道................................................................................................................................ 280 5. 应用导向器置钉优势突出............................................................................................................ 312 5.1 运用导向器使置钉更安全.................................................................................................. 312 5.2 导向器操作简便.................................................................................................................. 323 5.3 经导向器置钉可减少术中透视.......................................................................................... 323 5.4 导向器适用于部分骶骨发育异常者 .................................................................................. 323 6. 适应症与禁忌症............................................................................................................................ 334 7. 对骨盆标本应用导向器置钉后的经验总结 ................................................................................ 334 8. 展望................................................................................................................................................ 345 结论 .............................................................................................................................................................. 35