医用机器人及计算机辅助导航手术系统在胫骨髓内钉手术中的设计与应用

目的以胫骨骨折闭合复位、带锁髓内钉手术为研究对象，开发医用机器人及计算机辅助导航手术系统，总结该系统的临床应用经验，优化系统的结构设计，评价系统的临床应用效果。方法应用机器人双目视觉空间定位技术，进行医用机器人的模块化、小型化、实用化结构设计，开发医用机器人及计算机辅助导航手术系统；对胫骨骨折进行机器人辅助复位、计算机辅助导航定位髓内钉置入；临床应用于30例闭合胫、腓骨骨折（胫骨中1／3骨折8例、胫骨中下1／3骨折17例、胫骨远1／3骨折5例；其中斜螺旋骨折16例，蝶形骨折5例，粉碎、多段骨折9例）。受伤至手术的平均时间为36h。记录总手术时间、系统连接建立时间、骨折闭合复位所需X线透视时间（C型臂透视次数）、每个远端锁定螺钉置入所需要的透视时间（C型臂透视次数）。髓内钉型号大小8／310～11／330。结果30例手术均按照机器人及计算机导航系统的预定程序，规划完成，但关键的操作（髓内钉入点置入、远端锁钉锁孔）是在机械臂精确定位的辅助下，由术者亲自完成。总手术时间平均为77min（46～110min）；系统连接建立时间5min（3～7min）；骨折闭合复位所需X线透视时间10．1s（7．0～18．0s），C型臂透视次数12次（9～21次）；每个远端锁定螺钉置入所需的透视时间2．9s（2．2～6．9s），C型臂透视次数7次（5～16次），并且所有远端锁孔均一次锁定成功。结论医用机器人及计算机辅助导航手术系统设计合理，系统的基本功能可满足胫骨带锁髓内钉手术中骨折闭合复位、锁钉准确置人、患肢牢靠固定的要求；系统结构安装简便、易于掌握，人机接口方便、安全，对于未来在创伤骨科发展智能化、微创化、数字化手术具有重要意义。

Robot-assisted and computer-guided intramedullary nailing for tibial fractures: design and clinical application

Objective To evaluate and investigate the clinical feasibility and curative effects of robot- assisted and computer- guided intramedullary nailing for tibia fractures. Methods Based on the technology of robot- assisted stereo visualization, a modular, mini- sized, practical robot- assisted and computer- guided system was designed. The system was used for fracture reduction and real- time tool navigation for 30 patients with close tibial and fibular fractures. They were treated with closed intramedullary nailing. There were 8 cases of median third fractures, 17 median and lower third fractures, and 5 lower third fractures. The average time for whole surgical procedure, the time for system registration, fluoroscopic time for fracture reduction and fluoroscopic time for distal locking were recorded. Sizes of unreamed and reamed tibial nails ranged from 8/300 to 11/330. Results All the 30 operations were performed by the robot- assisted and computer- guided system successfully. Fracture reduction was conducted by the robot, but intramedullary nail insertion and distal locking were performed by the orthopedists with the help of robot. The average time for whole surgical procedure was 77 min (46 to 110min), the time for system registration was 5 min (3 to 7 min), fluoroscopic time for fracture reduction was 10.1 s (7 to 18 s) and fluoroscopic time for distal locking was 2.9 s (2.2 to 6.9 s). Conclusions The preliminary clinical experience has shown that all the steps of the procedure, including fracture reduction and intramedullary nail placement can be performed by the robot- assisted and computer- guided orthopedic surgery system. It can attain a new level of minimal invasiveness and operative precision. As robotic surgery is still in its infancy, further research in this field is worthwhile.