研究生: |
楊珣 Xun Yang |
---|---|
論文名稱: |
REBOA球囊支架的設計與製作 Design and Fabrication of REBOA Balloon Stents |
指導教授: |
張復瑜
Fuh-Yu Chang |
口試委員: |
林原慶
Yuan-Ching Lin 鄭有森 Yu-Sen Cheng |
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: | 2019 |
畢業學年度: | 107 |
語文別: | 中文 |
論文頁數: | 166 |
中文關鍵詞: | REBOA 、出血性休克 、支架 、球囊 、鎳鈦合金 |
外文關鍵詞: | REBOA, hemorrhagic shock, stent, balloon, nitinol |
相關次數: | 點閱:137 下載:0 |
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急救性主動脈球囊阻斷術(Resuscitative Endovascular Balloon Occlusion of the Aorta, REBOA)是一種出血性休克的急救方式,當患者腹部或骨盆以下遭受重創並無法有效直接加壓止血時,可用REBOA進行胸主動脈或腹主動脈的暫時性止血,以避免患者因出血性休克而死亡。
本研究開發出一款外徑為6Fr(2mm)之可縮放REBOA球囊支架,並利用有限元素模型,進行模擬及改善設計,目標解決目前市售REBOA導管(catheter)直徑較大(於患者股動脈易產生干涉問題)、須以X光輔助置放及觀測其擴張情形、以及治療中縮放球囊(balloon)讓血液通過時易產生位移等問題。本研究先製作與設計之球囊支架尺寸及特徵相同的不鏽鋼與鎳鈦支架試片,分別進行擴張量、壓縮力、與徑向力之量測,並與理論模擬結果進行比較及分析,結果顯示所建立的有限元素模型,套用不鏽鋼與鎳鈦材料參數,均能成功預測支架試片的應力應變情形。
為了找出最適合的球囊支架設計,本研究針對三種使用情境組合(支架、球囊和有無使用液體輔助擴張),利用有限元素模型分析其作用時與血管的接觸狀況,探討是否能達到球囊支架置入後阻擋血流的目的,且針對設計參數進行支架應變量的優化,以決定最終球囊支架原型設計。本研究並探討不同熱處理的時間與溫度對鎳鈦支架形狀記憶及機械特性的影響,並決定以熱處理溫度310C及時間1分鐘為球囊支架原型的熱處理參數。本研究最後以雷射加工、喷砂、酸洗、電解拋光、及熱處理製程,完成所設計的REBOA球囊支架原型,並進行測試及分析。
Resuscitative endovascular balloon occlusion of aorta (REBOA) is a first-aid treatment of hemorrhagic shock. While patient’s abdomen or pelvis was under severe trauma and non-compressible hemorrhage, REBOA could be applied for temporary occlusion in aorta in order to prevent patient from death due to hemorrhagic shock.
In this study an innovative REBOA balloon stent, retrievable and with 6 Fr diameter, was designed and improved by using finite element simulation and analysis. The goal of this design is to deal with the problems which appear on the current REBOA catheters. For example, the diameter is too large and may cause interference in femoral aorta, an X-ray system has to be used to assist monitoring the position and inflation of balloon, temporarily deflating the balloon to let the blood pass could result in the migration of balloon, and so on.
For experimental study, stainless and nitinol stent samples, which had similar features and dimensions with designed stent, were made to proceed the measurement of expanded diameter, axial and radial force, and the measured result was compared with the theoretical work. The result showed that the built theoretical model in this study can predict the stress-strain behavior of the samples successfully.
In order to find the best design of REBOA balloon stent, three types of combination (stent, balloon, with or without saline assistance) were conducted to simulate the contact situation with aorta and investigate if they could achieve the goal of occlusion. Also, the optimization of design parameters were conducted to determine the final design of balloon stent prototype. This study also investigated the effect of different heat treatment time and temperature on the shape memory function and mechanical properties of nitinol stents, and finally it was decided to use 300˚C with 1 minute as the parameters of heat treatment for the final prototype. After processing with laser cutting, sand blasting, acid pickling, electro-polishing and heat treatment, the final REBOA balloon stent prototype was fabricated, then tested to verify if it can meet the goal of this study.
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