In situ venous valve device and method of formation

摘要

A venous valve device and method of formation are described to provide antegrade blood flow in the deep venous vessels of the leg or in other venous vessels of the body having incompetent or irreversibly dysfunctional valves. A venous valve is formed in situ from autologous vein conduit not having a valve present locally. An overlap region is formed by attaching two opposing walls of the vein together in a generally axial direction forming two tubular regions. One region provides antegrade blood flow and the other region provides a sinus cavity that is filled during the initiation of retrograde blood flow. A valve cusp is formed by attaching vessel wall together forming a commissure that extends between the two overlap regions. A single valve cusp moves toward the sinus cavity to allow antegrade blood flow and moves away from the sinus cavity to block retrograde blood flow. Inlet and outlet transition regions can be formed to provide hemodynamic antegrade blood flow through the valve. The autologous tissue valve remains endothelialized to prevent thrombus deposit in the valve. The venous valve can also be formed from biological tissue from an autologous, heterologous, or other tissue source and implanted interpositionally at the site of valvular incompetency.