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研究生: 白雅云
Ya-Yun Pai
論文名稱: 聚合物支架取栓系統開發及體外試驗
Development and In Vitro Test for Polymer Stent Retriever Systems
指導教授: 張復瑜
Fuh-Yu Chang
口試委員: 林建宏
Chien-Hung Lin
何羽健
Yu-Chien Ho
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: 2022
畢業學年度: 110
語文別: 中文
論文頁數: 152
中文關鍵詞: 缺血性腦中風取栓支架3D列印體外系統
外文關鍵詞: Ischemic Stroke, Stent Retriever, 3D Printing, In Vitro System
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  • 缺血性中風常見的原因是腦血管堵塞導致腦部缺氧,現在已逐漸開始使用機械取栓術進行缺血性中風的治療。但機械取栓裝置在臨床使用上還有許多問題,例如以取栓裝置取栓易導致血管壁損傷、取栓過程易造成血栓破裂而導致遠端血管栓塞、對於老化或鈣化血栓的取栓結果較差等。
    因此,本研究嘗試開發新型的聚合物支架取栓系統以改善目前取栓手術在臨床上會遇到的困境,並建立一系列的體外取栓模型進行驗證。聚合物支架的幾何結構為參考市售取栓支架的設計概念進行設計,並規畫列印路徑及調控列印參數進行所設計聚合物支架的3D列印製作。支架材料使用熱塑性共聚酯 (Thermoplastic Copolyester, TPC),而非市售取栓支架常用的鎳鈦合金,藉由使用更柔順的支架材料來改善支架取栓可能導致血管壁損傷的問題。另外,本研究嘗試以旋轉取栓,及搭配氣球導管使用的吸出裝置,探討解決鈣化血栓的取栓結果較差及血栓破裂而導致遠端血管栓塞等現行取栓技術需克服的問題。
    本研究建立了模擬血管內取栓的體外支架取栓驗證模型,並製作了鈣化血栓模擬物用於此驗證模型。藉由所建立的體外取栓模型及鈣化血栓模擬物,本研究初步驗證所開發的新型聚合物支架取栓系統應可成功解決現行機械取栓術需克服的問題。


    The common cause of ischemic stroke is a blockage of blood vessels that leads to a lack of oxygen in the brain, and using mechanical thrombectomy is gradually being used for the treatment of ischemic stroke. However, there are still many problems in the clinical practice of mechanical thrombectomy devices. For example, thrombectomy with stent retrievers can easily lead to vascular wall injury, thrombosis rupture leading to distal vascular embolism, and poor thrombectomy results for aging or calcified thrombosis.
    Therefore, this study attempted to develop a new polymer stent thrombectomy system to improve the clinical difficulties encountered in the current thrombectomy and established a series of in vitro thrombectomy models for verification. The geometric structure of the polymer stent was designed according to the design concept of commercially available thrombectomy stents, and the printing path and printing parameters were planned to make 3D printing of the designed polymer stent. Using thermoplastic copolyester instead of Nitinol, which is commonly used in commercially available thrombectomy stents, ameliorates the problem of vascular wall damage caused in stent thrombectomy by using a more flexible stent material. In addition, this study attempted to solve the problems that the current thrombectomy technology needs to overcome, such as poor thrombectomy results of calcified thrombus and distal vascular embolism caused by thrombosis rupture, by using rotary thrombectomy and aspiration device with a balloon.
    In this study, an in vitro stent thrombectomy validation model simulating intravascular thrombectomy was established, and a calcified thrombus analog was made for this validation model. An established in vitro thrombectomy model and calcified thrombus mimetic demonstrated that the new polymer stent thrombectomy system can successfully solve the problems that the current mechanical thrombectomy needs to overcome.

    摘要 I Abstract III 誌謝 V 目錄 VI 圖目錄 XI 表目錄 XVIII 1 第一章 緒論 1 1.1 研究背景 1 1.2 研究動機與目的 5 2 第二章 文獻回顧 8 2.1 機械取栓裝置介紹 8 2.1.1 線圈回收器 8 2.1.2 吸出裝置 9 2.1.3 支架取回器 11 2.2 自擴張支架 13 2.2.1 熱塑性共聚酯(Thermoplastic Copolyester, TPC) 13 2.2.2 鎳鈦合金材料性質 15 2.2.3 自擴張支架比較 16 2.2.4 自擴張支架徑向力 18 2.3 血栓 25 2.3.1 血栓的組成 25 2.3.2 血栓形成的位置 27 2.3.3 鈣化血栓形成原因 29 2.4 取栓手術 31 2.4.1 體外血栓切除測試 31 2.4.2 傳統鈣化腦栓塞治療方法 33 2.4.3 新興聯合取栓手術 37 3 第三章 實驗方法 41 3.1 支架取栓系統設計 43 3.1.1 支架取栓系統設計概念 43 3.1.2 TPC支架設計 47 3.1.3 血管粗化 57 3.1.4 支架取栓性能 58 3.1.5 支架扭轉 60 3.1.6 氣球導管 61 3.1.7 吸出裝置 62 3.2 支架3D列印製作 65 3.2.1. 3D列印機及TPC線材 65 3.2.2. 3D列印路徑規劃 67 3.2.3. 3D列印製程參數 70 3.3 血栓製作 71 3.3.1. 新鮮血栓材料參數 71 3.3.2. 鈣化血栓材料參數 72 3.3.3. 新鮮血栓和鈣化血栓類似物製作 73 3.4 體外取栓驗證實驗 75 3.4.1 驗證實驗一 (單純支架取栓) 76 3.4.2 驗證實驗二 (支架旋轉取栓) 78 3.4.3 驗證實驗三 (搭配遠端氣球及吸出裝置) 79 3.5 實驗設備 82 3.5.1 3D列印機台 82 3.5.2 電磁加熱攪拌機(Hot Plate and Magnetic Stirrer) 83 3.5.3 壓縮裝置(Crimping Device) 85 3.5.4 平板壓縮裝置(Loadcell) 85 3.5.5 自動智能抽水器 87 4 第四章 實驗結果與討論 88 4.1 以3D列印製作支架 88 4.1.1 支架尺寸量測結果 88 4.1.2 支架徑向力實驗結果 89 4.1.3 支架尺寸及徑向力結果分析 91 4.1.4 扭轉支架 91 4.2 支架取栓性能實驗結果 93 4.2.1. 新鮮血栓加光滑血管 93 4.2.2. 新鮮血栓加粗化血管 94 4.2.3. 鈣化血栓加光滑血管 95 4.2.4. 鈣化血栓加粗化血管 96 4.2.5. 結果分析與改善 96 4.3 體外取栓驗證實驗結果 99 4.3.1. 驗證實驗一 (單純支架取栓) 結果 99 4.3.2. 驗證實驗二 (支架旋轉取栓) 結果 109 4.3.3. 驗證實驗三 (搭配遠端氣球及吸出裝置) 結果 118 5 第五章 結論與未來展望 124 5.1 結論 124 5.2 未來展望 126 參考文獻 128

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