2012-02-012024-05-14https://scholars.lib.ntu.edu.tw/handle/123456789/656583摘要：使用預先成型鈦網頭片來執行顱骨重建手術，可使患者顱顏恢復原有之對稱 外觀，並且可縮短手術時間，降低感染機率。預先成型式鈦網頭片國内目前主要 來源為國外進口產品，售價昂貴之餘，尚有以下使用困擾：（1)術中軟組織覆蓋 困難，（2)邊緣翹曲剝離，周圍固定釘可能產生疲勞滑脫，（3)不同型態之顱顏缺 損，缺乏最適之固定方法，（4)缺乏便利的手術器械。本計畫目的在於研發客製 化鈦網頭片之最佳化設計準則與計算模組，針對不同顱顏缺損型態，產生最佳鈦 網頭片之設計與固定方式，並於產品製造後，以力學測試驗證其機械強度與疲勞 而才受性，並發展配套之手術器械。寶元科技為國内少數同時掌握醫學影像處理、逆向工程計算、機械製造等關 鍵技術的醫療器材公司，本計畫將借助其關鍵技術，配合台大醫工所自有之虛擬 骨材設計平台與精密醫材測試平台，在兩年的計劃執行期間陸續完成：量化鈦網 頭片之最適微調度、定義鈦網頭片之最適機械強度、建構鈦網頭片最佳設計運算 模組、生產客製化鈦網頭片與配套之手術器械、產品安全性測試等工作項目。期 望藉著計畫之執行，可促進國内高品質之客製化鈦網頭片研發製造，協助提升國 内醫療器材自有品牌之國際競爭優勢。<br> Abstract: The merits of customized pre-shaped Titanium mesh plates for cranioplasty surgery include symmetry restoration of large cranial defects, surgery time reduction, and lower post-surgical infection rate. In Taiwan, most cranioplasty plates are imported from developed countries. Not only these plates are expensive, but also neurosurgeons often encounter many difficulties in using these imported plates, e.g., (1) insufficient soft tissue coverage during surgery, (2) fatigue pull-out of fixation screw induced by unfitted edges, (3) lack of optimized fixation patterns for different defect types, (4) lack of convenient surgical instruments. The objective of this project is to develop a design system to fabricate customized titanium cranioplasty mesh plates. The system will include an optimized design guideline and a computation module to design the optimized plate shape and fixation pattern for different cranial defect types. The optimized guideline and computation algorithm will be verified by evaluating the mechanical strength and fatigue strength of the plate. Lastly, the accompanying surgery instruments will be developed to facilitate the surgery.Pao-Yuen Tech, based in Taiwan, is a growing medical device company, owning many kernel technologies including medical image progressing, reverse engineering, and high-precision free-form manufacturing. This project will synergize Pao-Yuen，s technologies with the virtual design platform of orthopedic implants and precision implant testing platform developed by our lab. The focus of the two-year project is the qualification of clinical adjustment of Titanium cranioplasty mesh plate, optimization of mechanical strength of the plate, establishment of design computation module and fabrication system for customized pre-shaped mesh plate, the accompanying surgical instruments, and the correspondent regulatory safety testing. It is hoped the results of this project is able to promote our domestic venders to produce high-quality and high-valued medical implants, especially cranioplasty related implants and fixation devices, and increase the venders strength for international market.