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研究生: 高慶隆
Ching-Lung Gao
論文名稱: 5-French鎳鈦膽道支架研發
Development of 5-French Nitinol Biliary Stents
指導教授: 張復瑜
Fuh-Yu Chang
口試委員: 湯孝威
Hsiao-Wei Tang
葉家宏
Chia-Hung Yeh
謝宏麟
Hung-lin Hsieh
張以全
I-Tsyuen Chang
學位類別: 碩士
Master
系所名稱: 工程學院 - 機械工程系
Department of Mechanical Engineering
論文出版年: 2017
畢業學年度: 105
語文別: 中文
論文頁數: 118
中文關鍵詞: 濕式雷射切割鎳鈦支架支架運輸系統
外文關鍵詞: wet laser cutting, Nitinol Stent, stent delivery system
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鎳鈦膽道支架(Nitinol Biliary Stent)為一種中空管狀結構的醫療器材,可將其壓縮到運輸系統(Delivery System)內,經由內視鏡的工作通道(Working Channel)放置到因腫瘤而窄化之病灶處,鎳鈦支架由運輸系統釋放後能因人體溫度自行撐開窄化之病灶,因此又稱自擴型膽道支架(Self-Expandable Biliary Stent)。
  本研究使用ANSYS輔助分析開發出能壓縮到5 French(Fr,約等於1.66 mm)運輸系統內之鎳鈦支架後,使用光纖雷射加工2 mm鎳鈦合金管材,並搭配濕式切割降低因雷射導致的熱影響,成功加工出線寬120 μm之鎳鈦支架。本研究採用不同的加熱時間探討鎳鈦支架擴張後的回縮量,並搭配本研究設計之擴張模具與壓克力遮罩,在僅提供支架徑向力的情況下擴張鎳鈦支架,成功將鎳鈦支架均勻擴張至直徑12 mm,接著使用錐度棒與支架壓縮器控制鎳鈦支架的壓縮量,並在結構完整的情況下將鎳鈦支架壓縮到5 Fr矽膠管內,最後將壓縮完成之鎳鈦支架釋放到36℃之水中,模擬鎳鈦支架在人體內擴張之情況,結果發現鎳鈦支架自行擴張到11.5 mm, 整體結構完整,沒有因壓縮而受到損壞或變形。


A Nitinol biliary stent is a medical device with hollow tube structure and used to deal with the bile duct obstruction. It is crimped into a delivery system, deployed to tumor or obstructive position, then expanding by itself to dilate the blockage of bile duct.
In this study, ANSYS was used to develop a biliary stent that can be crimped in a catheter with 5 French (Fr) diameter and expanded to 12 mm diameter. Nanosecond fiber laser was determined to cut a 2 mm diameter Nitinol tube to fabricate the designed biliary stent. A wet laser cutting method was applied to reduce heat affected zone (HAZ), and stents with strut width 120 μm were successfully fabricated.
In addition, this study investigated the retraction rate of expanded stents with different heat treatment time and temperature. A stent expanding tool was designed and applied to expand stents to 12 mm diameter uniformly, with only radial expanding force. After that, the expanded stents were crimped into 5 Fr catheters and then released. The results showed the released stents could self-expand to more than 11.5 mm easily and their struts were all in good shape, without any significant damage.

摘要 I Abstract II 誌謝 III 目錄 IV 圖目錄 VII 表目錄 XI 第一章、 緒論 1 1.1. 膽道疾病 1 1.2. 研究動機 3 1.3. 研究目的 5 第二章、 文獻回顧 7 2.1 鎳鈦支架 7 2.2 鎳鈦合金的材料機械性質 9 2.3 鎳鈦合金熱處理參數 14 2.4 雷射原理與特性 18 2.4.1 雷射原理 18 2.4.2 雷射光斑直徑 19 2.4.3 雷射剝離閥值 20 2.4.4 雷射掃描速度 22 2.5 雷射加工文獻回顧 23 第三章、 實驗流程 34 3.1 鎳鈦支架設計與模擬 37 3.1.1. 支架繪製 37 3.1.2. 建立有限元素模型 39 3.1.3. 定義材料性能 39 3.1.4. 網格大小收斂性分析 41 3.1.5. 支架壓縮與擴張模擬設定方法 44 3.2 光纖雷射加工 45 3.2.1. 光纖雷射系統 45 3.2.2. 光纖雷射實驗規劃 48 3.2.3. 光纖雷射加工參數 49 3.2.4. 雷射加工路徑規劃 54 3.2.5. 膽管支架材料選用 56 3.2.6. 濕式雷射加工 57 3.3 膽管支架擴張與壓縮製程 60 3.3.1 膽管支架擴張製程 60 3.3.2 擴張設備 61 3.3.3 膽管支架壓縮製程 64 3.3.4 壓縮設備 65 3.4 實驗儀器 67 3.4.1. 掃描式電子顯微鏡 67 3.4.2. 光學顯微鏡 68 3.4.3. 超音波震盪機 68 第四章、 實驗結果與討論 70 4.1. 膽管支架設計與模擬 70 4.1.1. Crown寬度設計 70 4.1.2. Strut長度設計 72 4.1.3. Crown高度設計 74 4.1.4. Connector寬度設計 76 4.1.5. Connector過渡曲線 78 4.2. 光纖雷射實驗 80 4.2.1. 支架切割路徑規劃 82 4.2.2. 支架餘料加工路徑 89 4.2.3. 支架融渣 91 4.2.4. 支架錯位問題修正 93 4.3. 支架擴張製程 96 4.3.1. 消除殘留應力 96 4.3.2. 熱處理時間與支架回縮量之關係 96 4.3.3. 模具擴張支架 97 4.3.4. 支架擴張成果比較 102 4.4. 支架壓縮製程 103 4.4.1. 鎳鈦支架分段壓縮 103 4.4.2. 鎳鈦支架壓縮後觀察 105 4.4.3. 鎳鈦支架釋放 106 4.4.4. 鎳鈦支架徑向力測試 109 第五章、 結論與未來展望 112 5.1. 結論 112 5.2. 未來展望 114 參考文獻 116

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