以自擴張環形熱壓轉印技術開發生物可降解支架｜國立臺灣科技大學博碩士論文系統

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研究生：	劉凡于 Fan-Yu Liu
論文名稱：	以自擴張環形熱壓轉印技術開發生物可降解支架 Utilizing Self-Expandable Circular Thermal Imprint to Fabricate Biodegradable Stents
指導教授：	張復瑜 Fuh-Yu Chang
口試委員:	楊申語 Sen-Yeu Yang 陳品銓 Pin-Chuan Chen
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：	2015
畢業學年度：	103
語文別：	中文
論文頁數：	106
中文關鍵詞：	環形轉印、生物可降解支架、鎳鈦合金
外文關鍵詞：	Circular imprint, Biodegradable stent, Nickel titanium alloy
相關次數：	點閱：245 下載：0
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　　聚乳酸(Polylactic acid，PLA)是目前被廣泛使用的生醫材料，其中包括手術縫線、心血管支架(stent)、組織工程支架(Scaffolds)、和藥物傳輸裝置等，在今日醫療技術有著重要的地位。PLA 更因其生物可降解特性及環保再生來源受到研究學者及產業界高度的關注。
　　本研究以環形鎳鈦模具及環型熱壓轉印技術開發生物可降解支架，透過環型鎳鈦結構擴張模擬進行分析與實驗量測，與平面熱壓實驗進行參數歸納，找出最佳填充參數，進而判斷環形轉印之最佳轉印參數，再利用現有設備開發一特殊環形轉印系統及製造方法成功備製出可降解PLA 支架。
　　本實驗更利用環型鎳鈦擴張技術與四片環型支架模具進行環形轉印實驗，並探討其成型特性。本研究利用環型鎳鈦擴張技術以環形熱壓方式成功成型出直徑6 mm、厚度0.45 mm 之心血管支架，由實驗結果得到在壓印時間20 分鐘、轉印溫度115°C 及轉印壓力0.1 MPa的製程條件下具有最佳的轉寫率。此環形轉印製程對於目前心血管和非心血管的生物可降解支架在製程及量產上，具有一定的貢獻及突破。

Polylactide (PLA) is currently used in a number of biomedical tools,　including sutures, stents, scaffolds, and drug delivery devices. PLA is a widely used polymer for biomedical devices which has received much　attention for its biodegradability and origin in renewable resources.

In this research, we present the fabrication of biodegradable stent by　self-expandable circular thermal imprint technology. Firstly, a special　designed self-expandable mold was applied to proceed the innovative　process. Through the circular Nitinol mold expansion force measurement　and flat thermal imprint experiments the operation parameters for　fabricating PLA stent with self-expandable circular thermal imprint were　found. Utilizing the expansion force of circular Nitinol mold, the　designed strut patterns were transferred to a PLA tube and a PLA stent　was produced by our circular thermal imprint process successfully.

Secondly, the self-expandable mold was used as a self-expandable　tool and a special designed circular mold were employed to fabricate PLA　stents. The circular mold was assembled by several parts for the purpose　of demolding easily. It makes draft angle from negative to positive when　we carry out a circular imprint process. PLA stents were fabricated using　the designed system and the experimental results indicate the special　circular imprint process with duration 20 minutes, imprint temperature　115C and imprint pressure 0.1 MPa can achieve the best stent pattern　transfer rate. The developed circular imprint system has successfully been　used to fabricate PLA stents with dimensions of diameter 6 mm and　thickness 0.45 mm. This study contributes to the fabrication and mass　production of biodegradable vascular and non-vascular polymer stents.

摘要 ............................................................................................................. i
Abstract ...................................................................................................... ii
目錄 ........................................................................................................... iii
圖目錄 ...................................................................................................... vii
表目錄 ..................................................................................................... xiii
第一章 、緒論 ....................................................................................... 1
1-1 研究背景 ...................................................................................... 1
1-2 研究動機與目的 .......................................................................... 1
1-3 論文架構 ...................................................................................... 3
第二章、文獻回顧 .................................................................................... 4
2-1 聚乳酸高分子簡介 ....................................................................... 4
2-2 聚乳酸特性 .................................................................................. 4
2-2-1 光學活性 ............................................................................ 5
2-2-2 分子量 ................................................................................ 7
2-2-3 結晶性 ................................................................................ 7
2-2-4 機械性質 ............................................................................ 8
iv
2-2-5 生物可降解性質 ................................................................ 9
2-3 微/奈米轉印技術 ....................................................................... 10
2-4 血管支架(Stents)簡介 ................................................................ 13
2-4-1 可降解支架製備相關方法 .............................................. 14
2-4-2 PLA 組織工程支架製備相關方法 .................................. 19
2-5 鎳鈦合金材料介紹 .................................................................... 19
2-6 鎳鈦合金熱處理 ........................................................................ 23
第三章、研究方法 .................................................................................. 25
3-1 實驗原理 ..................................................................................... 25
3-1-1 模具材料選用 .................................................................. 25
3-1-2 鎳鈦模具之擴張製程 ...................................................... 26
3-2 實驗設備 ..................................................................................... 27
3-2-1 微/奈米轉印機台 ............................................................. 27
3-2-2 光纖雷射系統 .................................................................. 28
3-2-3 擴張設備 .......................................................................... 30
3-2-4 壓縮設備 .......................................................................... 32
3-2-5 熱風循環烘箱 (Cyclic Oven) ......................................... 34
3-3 量測儀器 ..................................................................................... 35
v
3-3-1 光學顯微鏡 (Optical Microscope, OM) ......................... 35
3-3-2 Z 軸量測平台................................................................. 36
3-3-3 熱示差掃瞄分析儀 (Differential Scanning Calorimeter)
..................................................................................................... 37
3-3-4 轉式動態流變儀(Modular Compact Rheometer) ....... 38
第四章、實驗規劃 .................................................................................. 40
4-1 材料及實驗製備 ........................................................................ 41
4-1-1 材料性質 .......................................................................... 41
4-1-2 黏度量測 .......................................................................... 43
4-1-3 PLA 管材製作 .................................................................. 44
4-2 環形熱壓轉印製程測試 ............................................................ 47
4-2-1 鎳鈦合金擴張力量測與模擬 ........................................... 48
4-2-2 鎳鈦模具平板熱壓轉印測試 .......................................... 51
4-3 環形熱壓轉印實驗 .................................................................... 55
4-3-1 環形熱壓轉印流程 ........................................................... 55
4-3-2 螺旋鎳鈦模具實驗 .......................................................... 57
4-3-3 環形鎳鈦支架實驗 .......................................................... 58
4-4 環形模具轉印製程實驗 ............................................................ 60
4-4-1 環形四片模具設計 .......................................................... 61
vi
第五章、實驗結果分析 .......................................................................... 63
5-1 鎳鈦合金擴張力量測與模擬分析 ............................................ 63
5-2 平板熱壓轉印結果與分析 ........................................................ 65
5-2-1 溫度測試結果 .................................................................. 65
5-2-2 轉印時間測試結果 .......................................................... 67
5-2-3 材料不同製程之測試結果 .............................................. 69
5-2-3 平板熱壓轉印測試結果與討論 ....................................... 71
5-3 環形熱壓轉印實驗結果與分析 ................................................ 72
5-3-1 向外轉印實驗結果 .......................................................... 72
5-3-2 向內轉印實驗結果 .......................................................... 74
5-3-3 螺旋模具轉印實驗結果 .................................................. 74
5-4 環形模具熱壓實驗結果與分析 ................................................ 76
5-4-1 環形模具轉印實驗結果 .................................................. 76
5-4-2 環形模具轉印實驗分析 .................................................. 78
第六章、結論與未來展望 ...................................................................... 82
6-1 結論 ..................................................................................... 82
6-2 未來展望 ............................................................................. 83
參考文獻 ................................................................................................... 84
                                

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