SUMMARY

Chronic Venous Insufficiency (CVI) is characterized by chronic venous hypertension, with venous reflux being a contributing factor in up to 94% of cases. The resulting symptoms include leg pain, varicose veins, fatigue, venous edema, skin pigmentation, inflammation, induration, and ulceration. A noninvasive treatment for deep venous reflux does not currently exist. A transcatheter prosthetic venous valve has the potential to be an effective, noninvasive treatment for deep venous reflux which could treat up to 1.4 million individuals in the United States suffering from venous ulceration and make more than 1.7 billion dollars each year. Previously developed prosthetic venous valves have had problems with competency, patency, thrombogenicity, biocompatibility, and incorrect sizing.

This thesis describes the design, analysis, pre-clinical testing, and evaluation of a novel prosthetic venous valve. Design specifications for an effective prosthetic venous valve were created. Finite element and computational fluid dynamic simulations were performed to analyze the valve. Verification tests were developed and performed which demonstrated that the valve met every design specification. An IACUC protocol for a 12 week study to test the valve in sheep was prepared and approved. A study to evaluate the valve in humans is proposed with endpoints that can be tested for statistical significance and compared with other treatments for CVI. A set of valves which will correct reflux in the majority of common femoral, femoral, and popliteal deep veins is proposed and a sizing guide for surgeons is provided. A comparison of this valve with previously developed prosthetic venous valves and recommendations for future work are given. As the valve proposed in this work is the only valve to meet all design specification for an effective prosthetic venous valve, this valve shows great potential to be an effective noninvasive treatment for deep venous reflux.