Adalyn Pederson

Chronic venous insufficiency (CVI) affects over 7 million Americans, resulting from faulty vein valves in the lower body that lead to blood reflux and pooling in the legs. This condition causes symptoms like pain, swelling, and leg ulcers. Current treatments are often ineffective, particularly for older or less active patients, highlighting the need for therapies that directly address blood reflux. This project tested and analyzed the reflux rates of sinused tissue-engineered vein valves (TEVVs), designed to prevent retrograde blood flow. Additionally, a standardized in-vitro validation method was developed to ensure the universal application of the reflux testing method across laboratories. A testing apparatus was constructed to replicate physiological pressures ranging from 40 to 160 mmHg, incorporating a safety factor of 2. A pinhole plug was designed in SolidWorks, and 3D-printed with specified parameters to produce a standard leakage volume as part of the validation method. Before vein valve testing can be conducted in a new lab, validation results must match those from this setup. The results of TEVV testing showed reflux rates exceeding the acceptable benchmark of 3 mL/min, suggesting that either the TEVV design or test method needs improvement. Observed leakage around the valve may have contributed to inaccuracies, prompting further refinement of the testing method. Despite these challenges, the project successfully developed and validated a universal testing protocol to improve future evaluations of TEVV performance. Future efforts will focus on optimizing valve testing under realistic deployment conditions to enhance CVI treatment effectiveness.