- 學位論文
基介入性人工心臟瓣膜之設計與分析
Design and Analysis of Transcatheter Heart Valve Leaflets
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摘要
心臟瓣膜疾病由於老化、感染、先天缺陷或鈣化等原因引起，會導致患者心臟血液輸送量下降，影響日常生活和運動，甚至可能導致其他心臟疾病。隨著全球人口老齡化，心臟瓣膜疾病的發病率逐漸增高。人工心臟瓣膜的更換是主要的治療手段之一，而經導管人工心臟瓣膜（TAVR）因其手術創口小、恢復快的優勢，成為一個越來越受歡迎的選擇。然而，這項技術在近十年內才獲得FDA許可，目前市面上經導管人工心臟瓣膜的選擇仍較少，相關研究對於設計參數上能提供的建議也較有限。 有鑑於此，本研究針對人工心臟瓣膜設計參數進行更有系統性的研究，期望能對於未來設計介入性人工心臟瓣膜時提供參考。本研究旨在構建一個基於參數化設計與統計學Box-Behnken設計（BBD）方法的介入性人工心臟瓣膜設計框架，並通過有限元素分析（FEA）、計算流體動力學（CFD）以及體外流場實驗對其性能進行全面量化和評估。本研究利用參數化設計方法，快速生成不同結構和尺寸的瓣膜設計方案，以滿足不同患者的需求。同時，利用Box-Behnken設計方法進行多參數優化分析，取得瓣膜設計參數與各項指標的顯著性關係，以實現最優的生物力學和血液動力學性能。 在有限元素分析中，本研究評估了人工瓣膜在生理環境中的結構強度和變形行為，著重於瓣膜材料在心臟周期性負荷下的應力應變分佈，確保其在開合過程中的耐久性和穩定性。通過計算流體動力學模擬，預測瓣膜的血液流動特性，包括血流速度分佈、流線以及湍流情況。為了驗證數值模擬結果的可靠性和可行性，本研究進行了體外流場實驗，並設計了一套電腦控制的模擬理想心臟環境進行性能測試，最終將結果與模擬數據進行對照。
並列摘要
Heart valve disease, caused by aging, infection, congenital defects, or calcification, leads to a reduction in cardiac blood transport, impacting daily activities and exercise, and potentially causing other heart conditions. With the global aging population, the incidence of heart valve disease is increasing. The replacement of artificial heart valves is one of the primary treatment methods, and Transcatheter Aortic Valve Replacement (TAVR) has become an increasingly popular choice due to its minimal invasiveness and rapid recovery. However, this technology has only been approved by the FDA in the past decade, and there are currently limited options for transcatheter artificial heart valves on the market, with insufficient research providing design parameter recommendations. Therefore, this study systematically investigates the design parameters of artificial heart valves, aiming to offer guidance for future designs of interventional artificial heart valves. This study establishes a design framework for interventional artificial heart valves based on parametric design and the statistical Box-Behnken Design (BBD) method, and comprehensively quantifies and evaluates their performance through Finite Element Analysis (FEA), Computational Fluid Dynamics (CFD), and in vitro flow field experiments. The parametric design method is employed to rapidly generate valve design schemes of different structures and sizes to meet the needs of various patients. Simultaneously, the Box-Behnken Design method is used for multi-parameter optimization analysis to determine the significant relationships between valve design parameters and various indicators, achieving optimal biomechanical and hemodynamic performance. In the Finite Element Analysis, the structural strength and deformation behavior of artificial valves under physiological conditions were assessed, focusing on the stress-strain distribution of valve materials under the cyclic loading of the heart to ensure durability and stability during opening and closing processes. Computational Fluid Dynamics simulations predicted the blood flow characteristics of the valve, including blood flow velocity distribution, streamlines, and turbulence. To verify the reliability and feasibility of the numerical simulation results, in vitro flow field experiments were conducted, and a computer-controlled simulated ideal heart environment was designed for performance testing, with the results ultimately compared with the simulation data.
參考文獻
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