3D列印醫材在脊椎手術導引件及客製化護具的進展

3D Printing Medical Device Breakthroughs on Guiding Template and Customized Brace

The cross-disciplinary collaborations between engineer and orthopedics surgeons began from 2002. Since year 2009 till now, the research team dedicated customized medical devices by 3D technology. We continuously obtained research funding from Ministry of Science and Technology, Ministry of Economy, and Ministry of Education. Gradually built up the research kernels of medical imaging decoding, image processing, and 3D reconstruction from DICOM medical imaging, to generate orthopedic expertise software and its' further medical applications. Finally, virtual objects designed on computer become materialization by rapid prototyping machine. The applicable research products or devices using in orthopedics include transpedicular screw trajectory planning training system, pedicle screw guiding templates in operation room, customized braces developed and manufactured. Aforesaid outcomes are completely base on our own developed kernel in expertise package software. The guiding templates for pedicle screw insertion are generated from each of the associated vertebra surface. It was constructed by our developed surgical planning software. Fitting and positioning of the guiding template sitting on associated vertebra are demanding in operation. Ultimate stability and precision of screw trajectory are our distinguishing futures. Integrated with the upgrade and refined peripheral devices step by step, we carefully moved from in Vitro experiments on swine cervical fixation to in Vivo on lumbar, thoracic, and high cervical vertebras fixation on patients. We have obtained predictable outcomes from the template of excellent stability and precision. Furthermore, we have developed method of interactive closest points for image fusion between pre- and post- computer tomography in order to assess the deviations between planning and post-op. Focus on complex and difficult syndromes, such as cervical subluxation, deformity, tumor, fracture, and scoliosis, we have applied on over 400 vertebras from over 130 patients. Angular deviations between screw trajectories of planning and post-op is less than 3 degrees in average. Deviation distances of entry points is less than 2 millimeters. All the screws are safely located inside the pedicle. Aside from that, actual models of either soft or hard tissues can be generated which is capable to benefit the correction of congenital kyphoscoliosis. In terms of our late research in customized braces development, we have uncovered the fitting allowances of brace by clinical trials in either cervical orthoses, wrist brace and, low back brace. It retains both wear comfort and affected part fixation without generating pressure sores. Besides, the outcomes provide an alternative choice of current off-the-shelf brace with many features in light weight, ventilation, convenience, comfort, strength enough, easy install, easy clean and, nevertheless, retaining both outlooks and personality design.