Biosafety Assessment of a Prototype Centrifugal Pump Rotor for Cardiac Assist System

The study explores the innovative application of stereolithography to address key material and technological limitations in left ventricular assist devices. Currently, the invasiveness of left ventricular assist device implantation presents a significant clinical challenge, and while early studies on miniaturization and less invasive implantation are promising, they encounter a fundamental limitation: blood clot formation. The root cause of this issue lies in the inherent limitations of conventional manufacturing processes, such as machining, which impede the precise optimization of blood flow dynamics within pump impellers. To overcome this significant barrier, a new approach to stereolithography has been proposed as an innovative 3D printing method to fabricate impellers with advanced biomimetic geometries, radically enhancing blood flow and minimizing the risk of thrombus formation. Moreover, the successful fabrication of these impellers with the stereolithography method relied on the development of a special composite material possessing the necessary mechanical properties. Hemocompatibility evaluations confirmed a low thrombogenic profile, minimal immunological response, and limited biological material accumulation. The findings of this research unequivocally demonstrate that stereolithography technology offers revolutionary potential in left ventricular assist device design and manufacturing, enabling the creation of highly complex and functional structures. However, preclinical validation of the long-term safety and durability of these additively manufactured components is essential prior to their translation into clinical application. Recent advancements in biomedical engineering have intensified the pursuit of more efficient and biocompatible circulatory support devices. Titanium impellers, while commonly used in commercial blood pumps, present limitations in terms of weight and hemocompatibility. In this study, a novel impeller design that demonstrates significantly reduced mass and enhanced resistance to clot formation was designed, addressing key clinical challenges associated with current technologies. The improved performance of these developed components highlights their potential for safe and effective long-term cardiovascular support.