"Previous studies have shown that even if a donor valve is found, implanting it can cause significant trauma to the patient's leg," explained Ku, who has doctoral degrees in mechanical engineering and medicine. "To avoid these complications, other prosthetic vein valves have been designed, but most have demonstrated poor clinical potential for humans."
Ku and his collaborators believe the valve they have developed will overcome previous difficulties. The one-way flap is made of poly(vinyl alcohol) cryogel, a material patented by Georgia Tech in 1999. The material has many useful attributes, including its biocompatibility with body tissue because of its attraction to water; the ability to adjust its mechanical strength; flexibility comparable to that of natural body tissue; and composition of organic polymer, rather than silicone.
The researchers will begin conducting preclinical animal trials at Emory University in October to test the in vivo biocompatibility and performance of the prosthetic vein valve prototype in sheep. Sheep were chosen because their cardiovascular geometry and physiology are similar to those of humans.
In each animal trial, two prosthetic vein valves will be implanted by Milner. The researchers will test the biocompatibility and performance of the devices for four weeks, using imaging techniques to check that the valves remain in the proper location, are open and allow blood to pass through the vein.
The animal trials will be conducted after several years of optimizing the valve design
|Contact: Abby Vogel|
Georgia Institute of Technology Research News