阻塞型睡眠呼吸中止症候群 (obstructive sleep apnea, OSA)，是指在睡眠期間，有短暫呼吸停止的現象，此現象與睡眠時上呼吸道狹窄有關。連續氣道正壓治療為現今睡眠呼吸中之症候群病患最主要選擇的治療方式。但大部分病患使用一段時間後，對於此治療方法會有排斥感，最主要的因素在他們所使用的鼻罩，在長久配戴後會有使用上的不方便及不舒適，甚至有幽閉恐慌的情形。
為了解決傳統鼻罩的缺點，首先經問卷調查瞭解顧的客需求，以產品使用者的觀點來考慮，導入品質機能展開(QFD)的方法，經由品質屋來分析後以：1.CPAP鼻罩之客製化開發、2.鼻罩內部流場分析、3.周邊機構與功能之改善，作為鼻罩開發之概念設計，依照此三項概念設計來規劃本研究之流程。
在客製化軟墊部分，首先是使用牙模粉搭配石膏粉複製病患的臉型，使用了逆向工程技術建構出臉部CAD模型，做為軟墊設計的基礎，再以快速原型技術設計與製造軟墊模具，應用此快速模具注入矽膠來獲得矽膠軟墊。此外以數值模擬氣流的方式，分析比較取得最佳鼻罩外型設計參數，接著將鼻罩周邊的零件機構做改良，讓鼻罩使用起來更為便利。新設計之原型是由快速原型技術所製造，並且由使用者評估裝配。
本研究提出一種新的方式，是透過快速模具來製作客製化軟墊，能讓軟墊達到更好的密合係數。如果客製化軟墊需求數量增加，可讓此項產品在價格上更具競爭力。最後建議幾項鼻罩設計與周邊機構之改善，可讓使用者提供方便及舒適的配戴效果。

People with Obstructive Sleep Apnea (OSA) may stop breathing momentarily during sleep due to the narrow upper respiratory tract. Nowadays, Continuous Positive Airway Pressure (CPAP) is one of the main treatments for OSA. However, most patients treated by this approach tend to complain the inconvenience and the uncomfortableness of the nasal mask after long-term use. Some may even encounter a serious problem of claustrophobia.
In order to reduce the drawbacks of the traditional nasal mask, this research first conducted surveys to understand the customers’ needs. Quality Functional Deployment (QFD) tools were applied to analyze the survey results and summaried the following subjects for nasal mask design improvement—development of customized cushion, analysis of the internal flowing fields in various nasal mask designs, and enhancement of peripheral components’ mechanism and their functions.
For the customized cushions, the patient’s face was first duplicated twice by Hydrogum and plaster. The face model, on which the cushion CAD design was based, was digitalized by the reverse-engineering technology. The tooling of the cushion was then designed and manufactured by rapid prototyping techniques. At last, silicone was cast into the rapid tooling to obtain customized cushions. The customized cushion was compared with other commercial cushions through fit factor test. The results of the customized cushion showed a great advantage over two other similar products. Besides, three nasal mask design parameters were proposed and the static air flow pattern was simulated respectively to conclude a better external shape of the nasal mask. Moreover, some design ideas of peripheral components were suggested to provide better functions and convenience. The prototypes of the new designs were fabricated by rapid prototyping technique and assembled for user evaluation.
This research has proposed a new approach to manufacture the customized cushion with better fit factor through rapid tooling. The cost of customized cushion can stay competitive if the required number is increased. The suggested nasal mask design and peripheral mechanisms are expected to provide convenient and comfortable wearing experiences for the users.

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