摘要
由於人們可能因為意外或老年疾病導致對骨科器材之需求，如年輕人可能因為運動發生骨折及扭傷，而老年人可能會罹患關節炎，因而骨科器材常見於各年齡層，其中人工關節、骨板系統需求量與高齡化社會也有相對的關係，隨著高齡化相關需求攀升，使得相關醫材與服務成為龐大商機。近年來台灣有許多傳統製造業者，也藉由技術水平整合，積極轉型切入醫材領域、跨足醫療器材業，此舉有助於提升技術研發能力、降低整體生產成本、同時改善台灣醫療器材業整體的競爭力。本文提出藉由鍛造製程配合CNC加工來節省材料與加工成本，不僅能強化骨板成品內部組職結構，也能擁有良好的表面精度。為了改善骨板加工生產方式，本研究針對骨板外型設計與鍛造模具方面來進行研究，透過電腦輔助有限元素分析，找出影響骨板強度的幾何外型並設計鍛造成形模具。 研究主要分為骨板外型分析、模具設計與成形分析、模具製作與鍛造實驗等三個部分，首先參考ASTM標準測試法，配合有限元素分析軟體對市售骨板產品進行強度探討，接著以螺絲孔為四孔的骨板為鍛件設計目標，設計其鍛件分模線與尺寸公差，並進行模具設計與金屬成形分析，探討不同胚料尺寸、模具設計與製程參數，藉由分析結果求出較佳的胚料尺寸、模具設計與製程參數，並進行模具製作與鍛造實驗，最後觀察鍛件外形與尺寸量測以評估是否修模，並將實驗結果與模擬結果進行比對，完成有限元素模擬分析的驗證。期望研究成果能對相關產業在骨板製程規畫與模具設計上有參考的價值。
並列摘要
People may need orthopedic equipment due to accidental injuries or age-related diseases. For examples, sports may bring youngsters fractures and sprains, while elderly people may suffer from arthritis. As a results, use of orthopedic equipment can be seen in all ages, making related medical materials and services a huge business opportunity. In recent years, many Taiwanese traditional manufacturers have horizontally integrated their technologies to transform and engage in the medical equipment and material market. This engagement can help the industry to improve the research and development capacity, reduce overall production costs, and meanwhile enhance the integrated competitiveness of the Taiwan medical equipment industry. This research proposes to use forging coupled with CNC processing to save the material and processing costs, so that the bone plate internal texture structure can be enhanced and the surface precision can also be perfected. To improve the bone plate processing approach, this article studies the designs of the bone plate appearance and forging molds. By way of a computer-aided finite element analysis, the impact of the 316L stainless steel bone plate's geometric appearance is discussed and a forging mold is designed. In the end, forging experiments are given. This research comes in three parts, which are bone plate appearance analysis, mold design and formation analysis, and mold making and forging experiments. To start with, the ASTM standard test method is taken, coupled with a finite element analysis software, to explore the strength of the bone plate. Then, the bone plate forging pieces and molds are designed and, through the metal formation analysis, billets of various specifications, the mold design, and production parameters are discussed. Based on a better parameterized data, the mold is then produced for the forging experiments. And then the appearance of the forging pieces is observed and the sizes are measured to decide whether modification on the mold is needed. The experiment results are compared with the simulation results to complete the verification of the finite element simulation analysis. The forging experiment reveals that the material's flow pattern is conformable to the trend of the simulative analysis, a confirmation of the accuracy of this research. Hopefully, the research results can provide useful reference to the bone plate production planning and mold designing.