Design of a Pulsatile Flow Facility to Evaluate Thrombogenic Potential of Implantable Cardiac Devices

摘要: Due to expensive nature of clinical trials, implantable cardiac devices should first be extensively characterized in vitro. Prosthetic heart valves (PHVs), an important class these devices, have been shown associated with thromboembolic complications. Although various vitro systems designed quantify blood-cell damage and platelet activation caused by nonphysiological hemodynamic shear stresses PHVs, very few attempt characterize both blood fluid dynamics aspects PHVs the same test system. Various numerical modeling methodologies are also evolving simulate structural mechanics, devices. This article presents a completely hemocompatible small-volume test-platform that can used for thrombogenicity studies experimental mechanics characterization. Using programmable piston pump drive freshly drawn human inside cylindrical column, presented system physiological pathophysiological conditions testing PHVs. The includes modular device-mounting chamber, this case, 23 mm St. Jude Medical (SJM) Regents® mechanical valve (MHV) aortic position was as device. validated its capability measuring induced tester itself (using whole blood). Blood levels were ascertained through clinically relevant assays on while using time-resolved particle image velocimetry (PIV) blood-mimicking fluid. itself, assessed Thrombin-anti-Thrombin (TAT), Prothrombin factor 1.2 (PF1.2), hemolysis (Drabkins assay), within accepted levels. hydrodynamic performance showed consistent, repeatable pressure flow conditions. In addition, contains proximity sensors accurately capture leaflet motion during entire cycle. PIV results skewing leakage jet, asymmetric closing two leaflets. All critical characterizing characteristics SJM MHV, proving utility precise assessing hemodynamics