Developing a Standardized Method to Determine Hemodynamic Properties of Prosthetic Vein Valves in-vitro Using a Pulse Duplicator
Chronic Venous Insufficiency (CVI) occurs when the vein valves (VV) in a patient's legs fail to keep blood flowing upwards to the heart. Implantable prosthetic VV that replace the patient’s malfunctioning valve have been proposed to address CVI. However, no standards for testing VV in-vitro currently exist. At the moment, the physiological peak forward flow, regurgitant, closing, and leakage volumes, diastolic and systolic pressures, positive change in pressure period, and leakage time for vein valves have not been explored in current literature from direct clinical measurements, but it was hypothesized that these parameters could be measured and calculated through in-vitro testing of prosthetic VV in the pulse duplicator. After conducting a review of previous research on VV to find physiological parameters on flow through the valves, values for three different flow rates through vein valves were determined for subjects performing various levels of activity. Then, data was collected using a pulse duplicator to test tissue-engineered VV in vitro by pumping a solution of deionized water and phosphate-buffered saline through the valve. The pulse duplicator software collected measurements on fluid flow as well as pressure measurements on both sides of the valve, which was analyzed in MATLAB to calculate the missing parameters and determine standards for testing tissue-engineered VV. These standards will hopefully help researchers, medical professionals and regulating bodies like the FDA characterize prosthetic vein valves using consistent and objective measurements, expediting their development.