下顎前置型口內止鼾裝置之機構設計

Abstract

本論文主要是針對下顎前置型之口內止鼾裝置做機構設計。透過市場調查、品質機能展開(QFD)、概念設計、有限元素分析法、決策矩陣法，提供一完整之工程設計流程。 在著手進行工程設計流程之前，首先要對打鼾機制進行了解。打鼾是一種普遍存在的現象，也是睡眠呼吸障礙症最顯著的表徵，忽略睡眠呼吸障礙症的治療將導致嚴重的健康問題。透過瞭解打鼾的機制以及診斷和治療方式之發展，確定了口內止鼾裝置之高療效以及病患高接受度，其中又以下顎前置型口內止鼾裝置為最。 市場調查包含市售產品調查及專利分析。根據市售產品調查，由於睡眠醫療逐漸受到重視，以及美國睡眠醫療學會(AASM)發表了口內止鼾裝置為打鼾之標準治療方式，自1995年起逐年皆有新的可調整式下顎前置型口內止鼾裝置問世。透過專利分析發現，目前的設計仍存在許多缺點有待改進，例如：佩帶舒適度、高價位、體積過大及不容易調整等，而在實際使用經驗上，更有裝置損壞之問題。 依據品質機能展開法之步驟，定義出顧客需求並將其轉換為可量化之工程規格，並評估市場現有產品規格，與其比較之後定義出最終的工程目標。接下來進行概念設計階段，使用子系統分解法將口內止鼾裝置分解成數個次系統，搭配使用腦力激盪法來結合出一系統化之程序，並產出四個最終概念。利用有限元素分析法對所有最終概念及一現有產品進行整體強度分析，來比較彼此間之效能優劣。最後，使用決策矩陣法，根據顧客需求的重要程度，從所有最終概念中挑選出最符合客戶需求之設計，再與品質機能展開法中所定義出之工程目標進行比較，其中有所差異之部分將可做為未來改善之參考依據。

This study focuses on the mechanism design of mandibular advancement devices (MAD). A complete engineering design process including market survey, quality function deployment (QFD), conceptual design and embodiment design is used. Before the design process proceeded, the realization of snoring is necessary. Snoring is prevalent and is the most significant feature of sleep-disordered breathing (SDB). Ignore the therapies of SDB will lead to serious problems in health. Based on the research of mechanisms, diagnosis, and treatments of snoring, oral appliances are ensured in therapeutic effect and compliance, especially the MAD. Market survey includes commercial product reviews and patent analyses. Due to pay more attention to the sleep medicine, the oral appliances are considered as a standard treatment of snoring that promoted by American Academy of Sleep Medicine (AASM). There are more and more adjustable MADs developed since 1995. According to the patent analyses, there are many drawbacks existing in the present design, such as uncomfortable, high cost, bulky volume, and complex to adjust, etc. According to the experiences of usage, this device is suffered from the failure problem which requires to be improved in the future. In accordance with the procedure of QFD, the customers’ requirements are obtained and translated to the measurable engineering specifications. Evaluate the commercial product to ensure the competition specifications, and set the engineering target at the end of the QFD process. In the conceptual design phase, a systematic procedure for generating concepts combines the functional decomposition which is used to divide the MAD into several sub-functions and the brainstorming method which is used to generate concepts for sub-functions. After that, four concepts are generated by the conceptual design process. The finite element analysis (FEA) is introduced to proceed the strength simulation for all of the concepts and one commercial product to evaluate the performance between each other. Finally, the decision-matrix method is used to evaluate all of the concepts based on the customers’ requirements and their own importance to select the best one. The comparison between engineering targets and specifications of the final design is carried out to estimate the performance of the final design, and to be considered as a criterion for further design works.