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  • 期刊

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

摘要


始於國科會(科技部),經濟部學界科專及教育部頂尖計畫的支持推動下,團隊於2002年開始合作磨合,於2009年開始投入骨科發展3D列印醫材的研究,開發醫學影像解碼與處理軟體、專家系統軟體、與醫學專用軟體的研發,進而以3D列印完成醫材的製造。團隊從脊椎手術教學系統開發開始,經術中的客製化鑽孔導引,以及術後護具的設計製造,均從自建的核心軟體出發,有多項專利及論文。椎足鑽孔導引手術計畫專用軟體,可提供由椎弓表面做三度空間的延伸,是個無中生有的設計,設計出導引件表面的契合度及位置是我們的特點,具極佳的穩定性與精準度。搭配設計的全套周邊器械,從豬隻實驗進入人體腰椎、胸椎、乃至進展到高位頸椎,都有極佳的穩定與精準度。以影像疊代技術,自動建立計畫與術後比對評估機制,針對困難複雜的案例,包含頸椎滑脫、椎節變形、腫瘤、骨折、脊椎側彎等等至今已施行了130多例個案,共超過400椎節的運用,術後與計畫骨釘路徑的平均角度差小於3度,進入點位移量小於2公釐(mm),所有鋼釘都在椎蒂內部。而且因為可以順勢產出實體模型,也運用於數例的脊椎天生的前側彎矯正。至於近期研究的客製化護具,包含術後的頸護具、腕護具、與背架,我們以科學方法找到符合穿戴舒適度的設計裕度,保有固定目的但又不至產生壓瘡的參數,進行臨床試驗,除兼具療效,更進一步提供現有護具在材料、透氣度、輕便性、舒適度、強度、造型的最佳選擇。滿足開刀的患者臨床上換藥保護與固定性功能,產品組裝容易,清洗簡單、通風、輕便,並可以依個人需求產出兼具美觀與個性化設計。

並列摘要


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.

參考文獻


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