機械心瓣為了延長使用年限，樞紐轉動部位的幾何形狀將是重要的關鍵。第四代三葉片機械心瓣最佳化參數改良研究，針對葉片重心、樞紐轉動部位幾何、制動裝置與運動機制關係、停靠背曲面進行研究改善。本研究機械心瓣的凹槽為下弦月C字型開口，更有益於流場的通過，其運作方式則利用側邊接觸的原理及搭配局部突出式之後置式制動裝置來控制葉片的閉合行為。
     藉由葉片平移測試及PRO/E 動態模擬進行分析，以確定合適的餘隙及干涉檢測分析。餘隙的研究將是掌控靈活度的關鍵，過猶不及將深深影響產品的安全性。另外，本研究所使用的參數將提供參考，以利下一代心瓣之設計。

In order to extend lifetime of mechanical heart valve (MHV), the geometric shape of hinge’s rotational part is an important key point. The study chose center-of gravity position, geometric shape of hinge, stopper and kinetic mechanism, improvement for stop-back, old-moon-C-shaped pivot as parameters has been design in this study, and it is helpful for flowing throughout. The closing behavior of leaflet is utilizing broadside touch and back-stopper. Move-test and Pro/E Mechanism module were used to analysis the gap and interference between the leaflets and housing ring. The gap is related to agile degree, so over or less could involve its safety. Moreover, the study will provide all parameters used in this research for designing future generations of MHV.

目錄
目錄	I
圖目錄	III
表目錄	IV
第一章 緒論	1
1.1 前言	1
1.2 研究目的、動機及方法	2
第二章 文獻回顧	3
2.1 機械式心瓣文獻回顧	3
2.2 人工心瓣發展史	9
第三章 三葉片機械心瓣設計理論及參數	10
3.1 機械心瓣的設計標的	10
3.2 機械心瓣的設計理論	11
3.2.1 葉片轉軸部位的設計理論	11
3.2.2 葉片關與開時之血液壓力、人體循環圖及瓣膜位置	11
3.2.3 前置式制動裝置與後置式制動裝置之比較	13
3.2.4 前置式與後置式的優缺點比較、機制	17
3.2.5 後置式制動裝置之改良設計	19
3.2.6 環座停靠背之研究	22
3.2.7 樞紐內壁的設計理論	23
3.2.8 靜態平移測試及自由度探討	24
3.2.9 縫合環之設計	25
3.2.10 可能影響流體的設計結構	26
3.3 三葉片心瓣的設計參數	27
3.3.1 進行流場研究之新型機械式三葉瓣的設計參數	27
3.3.2 樞紐及環座的設計參數	27
3.3.3 防震結構的設計參數	30
第四章 材料及實驗流程	32
4.1 工程材料性質	32
4.2 實驗設備	35
4.3 加工、繪圖流程及實際測試流程	36
4.3.1 CAD製作流程	36
4.3.2 加工流程	37
4.3.3 實際測試流程	38
第五章 三葉片機械心瓣軸承功能特性探討	39
5.1 側邊接觸理論	39
5.2  “8”字型凹槽與“C” 字型凹槽的比較	40
5.3 動態模擬及干涉檢測	41
5.4 第四代機械心瓣軸承功能特性探討	42
5.5 葉片與環座工程圖	45
5.5.1 公差及配合	53
5.6 葉片投影輪廓線方程式	54
第六章 結果討論	61
6.1 結果討論	61
6.2 設計參數整合表	66
6.3 比較本研究及國外心瓣的優缺點	72
6.4 成品拍攝分析	73
第七章 結論及建議	77
7.1 總結	77
7.2 設計上的挑戰性	78
7.3 葉片設計極限、加工極限	79
7.4 未來研究方向建議	80
參考文獻	82
附錄	84

圖目錄
圖1. 臺灣地區主要死因死亡率趨勢圖......................................................4
圖2. 人體循環圖........................................................................................12
圖3. 制動裝置種類....................................................................................16
圖4a. 接觸面是靠近制動裝置的下游曲面(改良前)...............................19
圖4b. 接觸面是靠近制動裝置的上游曲面(改良後)...............................20
圖4c. 主要接觸區範圍..............................................................................20
圖5a. 停靠背的改善方式..........................................................................22
圖5b. 易產生血栓之停靠背形式..............................................................23
圖6a. 外環式縫合環..................................................................................25
圖6b. 內溝式縫合環..................................................................................26
圖7. 開放式凹槽種類................................................................................29
圖8. CAD設計流程圖................................................................................36
圖9. 加工流程圖........................................................................................37
圖10. 研究目標流程圖..............................................................................38
圖11. 轉動接觸區......................................................................................39
圖12. 樞紐種類..........................................................................................42
圖13. 環座細部圖解..................................................................................45
圖14. 環座上視圖(上)、環座下視圖(下)................................................46
圖15. 葉片細部圖解..................................................................................47
圖16. 葉片樞紐局部視圖、透視圖..........................................................48
圖17. 關閉組立圖......................................................................................49
圖18. 開啟組立圖......................................................................................50
圖19. 葉片重心位置..................................................................................52
圖20. 葉片上、下表面投影圖樣..............................................................54
圖21. 葉片上投影面..................................................................................55
圖22. 葉片下投影面..................................................................................55
圖23. 葉片上表面投影輪廓線參考點......................................................56
圖24. 葉片下表面投影輪廓線參考點......................................................57
圖25. 葉片上表面投影視圖趨勢線方程式..............................................59
圖26. 葉片下表面投影視圖趨勢線方程式..............................................60
圖27. 迴圈式效應流程圖..........................................................................62
圖28a. C字型滑道(頂視圖)....................................................................64
圖28b. C字型外輪廓(正視圖)................................................................64
圖28c. 凹槽的弧形面..............................................................................65
圖29. 參數等級塔......................................................................................67
III
圖30. 葉片參數..........................................................................................71
圖31. 人工心瓣模型..................................................................................73
圖32. 葉片開啟過程..................................................................................74
圖33. 葉片閉合過程..................................................................................75
圖34. 生理波形圖......................................................................................76
圖35. 正向工程搭配逆向工程流程圖......................................................80
圖A. ATS...................................................................................................84
圖B. TRIFLO............................................................................................84
圖C. 第二代心瓣(水滴型葉片)...............................................................85
表目錄
表1. 台灣地區主要死亡原因......................................................................5
表2. 心瓣發展史..........................................................................................9
表3. 葉片開啟及閉合行為探討................................................................14
表4. 平移測試參數....................................................................................24
表5. 材料物理性質(一).............................................................................33
表6. 材料物理特性(二).............................................................................34
表7. 蝴蝶型凹槽與C字型凹槽比較.........................................................40
表8-1. 球形樞紐功能特性表....................................................................43
表8-2. 錐形樞紐功能特性表....................................................................43
表8-3. 柱狀樞紐功能特性表....................................................................44
表8-4. 圓形樞紐功能特性表....................................................................44
表9. 葉片上、下投影輪廓線參考點座標................................................58
表10. 直接因子及間接因子......................................................................66
表11. 第四代人工心瓣參數彙總表..........................................................68
表12. 影響因子..........................................................................................69
表13. 國內外機械心瓣比較......................................................................72

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