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 |
相關次數: | 點閱:294 下載:0 |
分享至: |
查詢本校圖書館目錄 查詢臺灣博碩士論文知識加值系統 勘誤回報 |
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.
[1] 台北榮民總醫院 (民47年7月1日)。一般外科學術論文專題-胰臟癌。民106年7月13日,取自 : https://wd.vghtpe.gov.tw/gs/Fpage.action?muid=863&fid=3908。
[2] 李金德(民102)。膽管癌之臨床診斷與治療。臺灣醫界,56,16-21。
[3] Johns Hopkins Medicine. Liver tumor center. Retrieved July 14, 2017, from http://www.hopkinsmedicine.org/liver_tumor_center/conditions/index.html
[4] Medical Devices Innovation Institute. Medical Devices Challenges and Opportunities for Enhancing the Health and Wealth of Canadians. Retrieved July 14, 2017, from https://c.ymcdn.com/sites/www.medec.org/resource/resmgr/Government_Submissions/Final_Medical_Devices_Challe.pdf
[5] Urakami, Y., Seifert, E., & Butke, H. (1977). Peroral direct cholangioscopy (PDCS) using routine straight-view endoscope: first report. Endoscopy, 9(01), 27-30.
[6] Raijman, I. (2013). Choledochoscopy/cholangioscopy. Gastrointestinal endoscopy clinics of North America, 23(2), 237-249.
[7] Larghi, A., & Waxman, I. (2006). Endoscopic direct cholangioscopy by using an ultra-slim upper endoscope: a feasibility study. Gastrointestinal endoscopy, 63(6), 853-857.
[8] 宋皚峰、劉乃仁(民105)。經口膽道內視鏡。內科學誌,27,174-178。
[9] 莊棠惟(民104)。上消化道內視鏡檢查另類選擇-經鼻內視鏡。奇美醫訊,109,39-40。
[10] Dumonceau, J. M., Tringali, A., Blero, D., Devière, J., Laugiers, R., Heresbach, D., & Costamagna, G. (2012). Biliary stenting: indications, choice of stents and results: European Society of Gastrointestinal Endoscopy (ESGE) clinical guideline. Endoscopy, 44(03), 277-298.
[11] Nguyen-Tang, T., & Dumonceau, J. M. (2011). A new method to facilitate bilateral hepatic duct drainage: simultaneous insertion of two thin 6-Fr self-expandable metal stents. Endoscopy, 43(S 02), E24-E25.
[12] Hodgson, D. E., Ming, W. H., & Biermann, R. J. (1990). Shape memory alloys. ASM International, Metals Handbook, Tenth Edition., 2, 897-902.
[13] Shabalovskaya, S. A. (2002). Surface, corrosion and biocompatibility aspects of Nitinol as an implant material. Bio-medical materials and engineering, 12(1), 69-109.
[14] Dolce, M., & Cardone, D. (2001). Mechanical behaviour of shape memory alloys for seismic applications 2. Austenite NiTi wires subjected to tension. International Journal of Mechanical Sciences, 43(11), 2657-2677.
[15] Otsuka, K., & Kakeshita, T. (2002). Science and technology of shape-memory alloys: new developments. mrs bulletin, 27(2), 91-100.
[16] Pelton, A. R., Dicello, J., & Miyazaki, S. (2000). Optimisation of processing and properties of medical grade Nitinol wire. Minimally Invasive Therapy & Allied Technologies, 9(2), 107-118.
[17] Liu, X., Wang, Y., Yang, D., & Qi, M. (2008). The effect of ageing treatment on shape-setting and superelasticity of a nitinol stent. Materials Characterization, 59(4), 402-406.
[18] 蔡宗河 (民84)。CO2雷射加工。臺北市:全華圖書股份有限公司。
[19] 林三寶 (民98)。雷射原理與應用。臺北市:全華圖書股份有限公司。
[20] Mannion, P., Magee, J., Coyne, E., & O’Connor, G. M. (2003). Ablation thresholds in ultrafast laser micromachining of common metals in air. In Proc. of SPIE Vol (Vol. 4876, p. 471).
[21] 許育豪 (民100)。飛秒雷射製作金屬玻璃微奈米轉印精密模具應用分析(碩士論文)。國立台灣科技大學。
[22] Kleine, K. F., Whitney, B., & Watkins, K. G. (2002, October). Use of fiber lasers for micro cutting applications in the medical device industry. In 21st International Congress on Applications of Lasers and Electro-Optics, Scottsdale.
[23] Baumeister, M., Dickmann, K., & Hoult, T. (2006). Fiber laser micro-cutting of stainless steel sheets. Applied Physics A: Materials Science & Processing, 85(2), 121-124.
[24] Muhammad, N., Whitehead, D., Boor, A., & Li, L. (2010). Comparison of dry and wet fibre laser profile cutting of thin 316L stainless steel tubes for medical device applications. Journal of Materials Processing Technology, 210(15), 2261-2267.
[25] Muhammad, N., & Li, L. (2012). Underwater femtosecond laser micromachining of thin nitinol tubes for medical coronary stent manufacture. Applied Physics A, 107(4), 849-861.
[26] Fu, C. H., Liu, J. F., & Guo, A. (2015). Statistical characteristics of surface integrity by fiber laser cutting of Nitinol vascular stents. Applied Surface Science, 353, 291-299.
[27] Chen, C. S., Lin, S. Y., Chou, N. K., Chen, Y. S., & Ma, S. F. (2012). Optimization of Laser Processing in the Fabrication of Stents. Materials Transactions, 53(11), 2023-2027.
[28] Wu, W., Qi, M., Liu, X. P., Yang, D. Z., & Wang, W. Q. (2007). Delivery and release of nitinol stent in carotid artery and their interactions: a finite element analysis. Journal of Biomechanics, 40(13), 3034-3040.
[29] 陳正宗 (民102)。膽管支架之設計與光纖雷射加工(碩士論文)。國立台灣科技大學。
[30] Kugler, T., & Naeem, M. (2002). Material processing with super modulation. ICALEO 2002 proceedings, Phoenix.
[31] Misawa, H., & Juodkazis, S. (Eds.). (2006). 3D laser microfabrication: principles and applications. John Wiley & Sons.
[32] 張國順、鄭壽昌 (民97)。現代雷射製造技術。新北市:新文京開發出版股份有限公司。
[33] 鄭博謙 (民104)。膽管支架擴張製程與可取回設計(碩士論文)。國立台灣科技大學。
[34] 吳子奇 (民105)。雷射切割膽管支架的可取回設計(碩士論文)。國立台灣科技大學。