In vitro blood flow model with physiological wall shear stress for hemocompatibility testing-An example of coronary stent testing.

Abstract

Hemocompatibility of blood contacting medical devices has to be evaluated before their intended application. To assess hemocompatibility, blood flow models are often used and can either consist of in vivo animal models or in vitro blood flow models. Given the disadvantages of animal models, in vitro blood flow models are an attractive alternative. The in vitro blood flow models available nowadays mostly focus on generating continuous flow instead of generating a pulsatile flow with certain wall shear stress, which has shown to be more relevant in maintaining hemostasis. To address this issue, the authors introduce a blood flow model that is able to generate a pulsatile flow and wall shear stress resembling the physiological situation, which the authors have coined the "Haemobile." The authors have validated the model by performing Doppler flow measurements to calculate velocity profiles and (wall) shear stress profiles. As an example, the authors evaluated the thrombogenicity of two drug eluting stents, one that was already on the market and one that was still under development. After identifying proper conditions resembling the wall shear stress in coronary arteries, the authors compared the stents with each other and often used reference materials. These experiments resulted in high contrast between hemocompatible and incompatible materials, showing the exceptional testing capabilities of the Haemobile. In conclusion, the authors have developed an in vitro blood flow model which is capable of mimicking physiological conditions of blood flow as close as possible. The model is convenient in use and is able to clearly discriminate between hemocompatible and incompatible materials, making it suitable for evaluating the hemocompatible properties of medical devices.