| 研究生: |
巫苡慈 Wu, I-Tzu |
|---|---|
| 論文名稱: |
關節鏡支撐系統初期研究:市場相關產品分析、醫療器材法規、骨科醫生訪談和微調機構設計 Preliminary study of arthroscopic holding system: analysis of market relevant products, medical device regulations, interviews with orthopedic surgeons, and fine-tuning mechanism design. |
| 指導教授: |
楊岱樺
Yang, Tai-Hua |
| 學位類別: |
碩士 Master |
| 系所名稱: |
工學院 - 生物醫學工程學系 Department of BioMedical Engineering |
| 論文出版年: | 2024 |
| 畢業學年度: | 112 |
| 語文別: | 英文 |
| 論文頁數: | 76 |
| 中文關鍵詞: | 關節鏡支撐器 、細調機構 、市場相關產品調查 、醫療器材法規 、骨科醫生訪談 |
| 外文關鍵詞: | Arthroscope holder, fine-tuning mechanism, market survey of relevant products, medical device regulations, orthopedic surgeon interview |
| 相關次數: | 點閱:72 下載:6 |
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關節鏡手術過程中,當執刀醫師需要使用雙手操作器械進行關節內組織修補、縫合…等動作時,往往會需要一名外科助手在旁協助執刀醫師手持固定關節鏡,並將關節鏡鏡頭對準執刀醫師指定的視野位置,但是往往執刀醫師與助手之間的溝通問題以及手部的生理或人為不經意的顫動容易導致造成術野晃動、偏移、模糊和失焦,進而影響醫師對患部的判斷與手術執行的效率,並增加手術的風險。為此本研究以先前開發的Prototype one為基礎,對被動式關節鏡支撐器進行臨床需求、市場 相關產品和醫療器材法規上的調查並與各個領域的專家進行諮詢。在設計方面, 經過與骨科醫生訪談了解他們對被動式關節鏡支撐器的需求後,與工程師討論被動式關節鏡支撐器的設計改良方向,並採納Prototype one需進行改良的問題點進行新的細調機構設計。最後綜合骨科醫生、各領域專家的意見以及市場調查的結果,判斷被動式關節鏡支撐器未來可能的發展方向及上市後的市場發展潛力。
During arthroscopic surgery, when the orthopedic surgeon requires both hands to manipulate instruments for intra-articular tissue repair, suturing, etc., an assistant is often required to assist the orthopedic surgeon to hold the arthroscope and align the arthroscopic lens with the position specified by the orthopedic surgeon. However, communication issues between the orthopedic surgeon and the assistant, as well as physiological or inadvertent hand tremors, can lead to instability, deviation, blurring, and out-of-focus of the operating field, thereby affecting the orthopedic surgeon's judgment of the affected part and the efficiency of the operation, and increasing the risk of surgery. This study builds upon the previously developed the first-generation prototype to address these challenges. Clinical needs, market-relevant products, and medical device regulations regarding passive arthroscopic holder were investigated, and consultations were held with experts from various fields. In terms of design, insights from orthopedic surgeons regarding their requirements for passive arthroscopic holder were gathered through interviews, discussions with engineers were conducted to explore directions for improving the design of passive arthroscopic holder, and new fine-tuning mechanism designs were developed to address the issues identified in the first-generation prototype. Finally, synthesizing the opinions of orthopedic surgeons, experts from various fields, and the results of market research, the potential future directions for passive arthroscopic holder and the market development prospects post-launch were assessed.
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