本研究的目的是設計出一個理想的人工心瓣。雖然人工心瓣發展已經超過半個世紀，但目前臨床上所使用的機械心瓣還是存在血栓與溶血等缺點，而生物心瓣卻有不耐用的問題。本文利用分析各種三葉片機械心瓣的專利和相關文獻，進而提出全新的改良設計。新設計的葉片與環座是完全以自由曲面所建構而成，外形平順完整而沒有突出的支架，具有圓滑的轉軸，使葉片能夠靈活地轉動。
然後以鈦合金製作實驗原型，提供實驗團隊進行體外流場實驗分析，以驗證新設計的流場性能表現與發展可行性。然後根據新設計的概念，提出美國專利申請，作為後續發展三葉片機械心瓣的基礎。
根據實驗原型的設計經驗，以全面的觀點來探討三葉片心瓣設計所可能遇到的問題與解決策略，歸納成初步的設計準則，提供後續研究人員作進一步的深入分析與討論。

The main objective of the thesis is trying to design the optimal heart valve prosthesis. Since 1952, when the first artificial heart valve was implanted in a human, cardiac surgeons have been looking for a perfect heart valve prosthesis. Currently, there are two major types of valve prostheses used clinically. Patients with mechanical valves require consistent anti-coagulation therapy to prevent complications like thrombosis and hemolysis. Biological valves have much less durability than mechanical valves. 
This thesis presents the completely redesigned mechanical heart valve from patent analysis. The novel trileaflet mechanical heart valve may have a capability to provide excellent valve durability and hemodynamics. The leaflets and ring are totally created by freeform surface modeling. The streamline shape design provides advantage of fluid dynamic and improves washing of the hinge regions that minimize blood clotting tendencies. Leaflets can rotate freely without much friction, but does not wobble.
According to the experience in prototype design, we provide the design critera of the trileafet mechanical heart valve. Furthermore, we have applied for a patent on the new trileaflet heart valve. The design concept was therefore adopted as the basis for the further study and development.

目錄
摘要	i
Abstract	ii
致謝	iii
目錄	iv
圖目錄	vi
表目錄	ix
第1章	緒論	1
1.1	前言	1
1.2	研究動機與目的	2
1.3	研究內容與方法	5
第2章	文獻回顧	6
2.1	人工心瓣的發展	6
2.2	專利分析	7
2.2.1	Bokros的三葉片心瓣設計	13
2.2.2	Lapeyre的三葉片心瓣設計	14
2.2.3	Otto的三葉片心瓣設計	16
2.2.4	Sievers的三葉片心瓣設計	19
2.2.5	Lentell的三葉片心瓣設計	20
2.3	心瓣產品的風險	23
第3章	設計演化	24
3.1	一號心瓣-三角圓端	24
3.2	二號心瓣-倒鉤箭頭	28
3.3	三號心瓣-箭頭	31
第4章	設計概念	34
4.1	心瓣的組成	34
4.1.1	葉片的特徵	35
4.1.2	環座的特徵	36
4.2	葉片的設計	36
4.3	轉軸的設計	40
4.3.1	軸孔的形狀	40
4.3.2	轉軸位移設計	44
4.3.3	軸孔血塊附著的問題	45
4.4	心瓣的組裝	47
4.5	心瓣葉片的接觸角	53
4.6	葉片下游嚙合的錯位	53
第5章	結論與建議	57
5.1	設計準則	57
5.2	階段發展策略	58
5.3	未來展望	60
參考文獻	61
　　
　　
圖目錄
圖1-1 心瓣解剖圖[1]	1
圖1-2主動脈心瓣展開解剖圖[1]	2
圖1-3 Hufnagel球閥人工心瓣[2]	3
圖1-4 St. Jude Medical Regent?雙葉片機械心瓣[3]	3
圖1-5 St. Jude Medical Biocor?生物心瓣[3]	4
圖1-6研究流程	5
圖2-1機械心瓣的種類[4]	6
圖2-2 Bokros一號三葉片心瓣[10]	13
圖2-3 Bokros二號三葉片心瓣[11]	13
圖2-4 Lapeyre一號三葉片心瓣[12]	14
圖2-5 Lapeyre二號三葉片心瓣[13]	15
圖2-6 Lapeyre三號三葉片心瓣[14]	15
圖2-7 Lapeyre三號三葉片心瓣[15]	15
圖2-8 Otto一號三葉片心瓣原型[16]	16
圖2-9 Otto三葉片心瓣流場示意圖[17]	17
圖2-10 Otto一號三葉片心瓣[18]	17
圖2-11 Otto二號三葉片心瓣[19]	17
圖2-12 Otto二號三葉片心瓣原型(閉合)[20]	18
圖2-13 Otto二號三葉片心瓣原型(開啟)[20]	18
圖2-14 Otto二號三葉片心瓣鈦合金原型[21]	18
圖2-15 Sievers早期設計的三葉片心瓣上視圖[22]	19
圖2-16 Sievers早期設計的三葉片心瓣[22]	19
圖2-17 Sievers反向三葉片心瓣[23]	20
圖2-18 Sievers反向三葉片心瓣葉片[23]	20
圖2-19 Lentell一號三葉片心瓣[24]	21
圖2-20 Lentell二號三葉片心瓣[25]	21
圖2-21 Lentell三葉片心瓣原型[26]	21
圖2-22 Lentell三葉片心瓣植入原型[27]	22
圖2-23接受三葉片機械心瓣置換的第一人[27]	22
圖3-1顏廉育的三葉片心瓣設計[35]	24
圖3-2圓滑外形的葉片	25
圖3-3一號心瓣上游視圖	26
圖3-4一號心瓣鞍型軸孔	26
圖3-5葉片旋轉置入示意圖	27
圖3-6葉片開啟時的轉軸位置	28
圖3-7二號心瓣的上游正視圖	29
圖3-8二號心瓣的葉片	29
圖3-9箭頭[36]	30
圖3-10二號心瓣的下游視圖	30
圖3-11二號心瓣的上游視圖	31
圖3-12三號心瓣的葉片	31
圖3-13葉片側角用於葉片關閉定位	32
圖3-14三號心瓣的下游視圖	32
圖3-15三號心瓣設計原型	33
圖3-16三號心瓣設計原型開啟狀	33
圖4-1三葉片心瓣	34
圖4-2葉片的特徵	35
圖4-3環座的特徵	36
圖4-4葉片關閉與開啟的角度	37
圖4-5葉片轉軸角度	37
圖4-6葉片弧線與外側流孔面積	38
圖4-7葉片開啟的停靠面	38
圖4-8葉片上游嚙合線	39
圖4-9環座軸孔的形狀	40
圖4-10葉片凹口側面的轉動範圍	41
圖4-11葉片旋轉軸的位移	41
圖4-12軸孔深淺與轉軸接觸角	42
圖4-13軸孔的空間差異	42
圖4-14葉片轉軸形狀的差異	43
圖4-15 Lapeyre心瓣的外形比較圖[38]	44
圖4-16葉片轉軸位移示意圖	45
圖4-17軸孔蟲洞的心瓣設計	46
圖4-18軸孔蟲洞的示意圖	46
圖4-19壓縮環座示意圖	47
圖4-20葉片旋轉置入軸孔示意圖	48
圖4-21轉軸形狀對組裝間隙的影響	49
圖4-22壓縮環座的三爪夾頭	49
圖4-23葉片軸距量規	50
圖4-24均勻厚度的環座	50
圖4-25縮小的環座內側嚙合面	51
圖4-26 ATS Open Pivot?心瓣環[40]	51
圖4-27碳環座與鈦強化箍環	52
圖4-28葉片上游嚙合面的間隙示意圖	52
圖4-29接觸角示意圖	53
圖4-30心瓣關閉時下游邊的間隙	54
圖4-31下游邊的錯位	54
圖4-32嚙合面的分類	55
圖4-33葉片下游嚙合面的復位機制	56
圖4-34虹膜式光圈簾[42]	56
表目錄
表2-1專利檢索條件的設定	9
表2-2三葉片機械心瓣的美國專利	10
表2-3技術功效矩陣表	12
表5-1 SWOT 矩陣策略表[43]	58
表5-2三葉片機械心瓣的SWOT分析[43]	59

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