骶髂关节复位固定接骨板的研发及其有效性验证  

A new type of sacroiliac reduction plate： design and safety evaluation

作　　者：吴新宝[1] 李宇能[1] 孙旭[1] 韦冬 

机构地区：[1]北京大学第四临床医学院北京积水潭医院创伤骨科北京市创伤骨科研究所,100035 [2]华森医疗器械有限公司

出　　处：《中华创伤骨科杂志》2014年第4期300-304,共5页Chinese Journal of Orthopaedic Trauma

基　　金：北京市科委科技创新基地培育与发展工程项目（Z131110002812121）

摘　　要：目的设计一种骶髂关节复位固定接骨板，并在骶髂关节脱位模型上验证其辅助复位功能和固定强度的有效性。方法①选取80例正常成年人骶髂关节CT平扫影像数据，应用Mimiesl0．0软件测量骶髂关节的解剖参数（s。椎体斜坡和髂窝的表面曲度），并以此参数采用UGN7．0软件确定接骨板的外形及其辅助复位的螺钉孔形状、数量和位置。②从收集的80例正常成年人骶髂关节CT平扫影像数据中选取15例测量骶髂关节间隙内倾角，确定接骨板近端孔、中间孔和远端孔的内倾角度。然后通过3D打印技术打印出接骨板模型，最后制作出真正的钛金属接骨板。③选取10具成年人骶髂关节尸体标本进行骶髂关节脱位造模和接骨板复位、固定的有效性评估。结果骶髂关节复位固定接骨板的髂骨侧分别设计了2组复位螺钉孔：①偏中间的一组椭圆孔（A孔）用于复位分离移位，偏两端的一组椭圆孔（B孔）用于复位向近端的移位。同时，在接骨板的中间设计5个螺钉孔，骶骨侧为3个，髂骨侧为2个，均设计为锁定螺钉。骶骨侧螺丝钉锁定孔方向：近端孔向内倾斜27°，中间孔向内倾斜24°，远端孔向内倾斜250；髂骨侧螺钉设计为垂直方向。在骶髂关节脱位模型上进行的接骨板复位和固定模拟操作结果显示：骶髂关节复位固定接骨板可以纠正垂直5mm及内外3mm的移位，并能获得牢固固定。结论新研发的骶髂关节复位固定接骨板同时考虑了接骨板的解剖形态、辅助复位功能和固定强度。从理论设计及尸体操作验证证实了其对骶髂关节复位与固定的有效性。Objective To test a self-designed new sacroiliac reduction plate in models of sacroiliac dislocation. Methods First, CT scan data of the sacroiliac joint from 80 normal adults were selected for measurement of the anatomic parameters （the vertebral slope of S1 and the intrailiac surface curvature） of the sacroiliac joint using Mimics 10. 0. The reduction plate was shaped and the shape, number, and position of the screw holes were determined according to the parameters using UGNT. 0. Secondly, the CT scan data of the sacroiliac joint from 15 normal adults were used to measure the intra-sacroiliac introversion angle, on the basis of which the introversion angles of the proximal, middle and distal holes of the reduction plate were determined. The actual titanium reduction plates were manufactured accordingly. Thirdly, we performed simulative surgery using the self-designed reduction plate in 10 aduh cadaveric models of the sacroiliac dislocation and evaluated the safety and efficacy of the plate. Results According to the measurements of the posterior pelvic ring in the 80 normal sacroiliac joint, 2 types of screw holes were deigned. The elliptical holes （hole A） of the central type were used for reduction of diastasis dislocation, and the elliptical holes of the polarization type （hole B） were used to reduce the proximal displacement. In the reduction plate, 5 locking screw holes were designed, 3 on the sacral side and 2 on iliac side. The holes on the iliac side were made perpendicular; on the sacral side, the proximal hole had a 27° introversion, the middle one a 24° introversion and the distal one a 25° introversion. The simulated operation showed that the new self-designed reduction plate could achieve rigid fixation, reducing displacements of 5 mm vertically and those of 3 mm laterally and medially. Conclusion Since the new self-designed reduction plate takes the anatomy, reduction and rigidity into consideration in the theoretical design, it proves effective by the cadaveric operation in the redu

关 键 词：骶髂关节 矫形外科固定装置 模型 解剖学 设备设计 

分 类 号：R687.3[医药卫生—骨科学]