Resumen
A major medical problem of state-of-the-art heart ventricular assist devices (LVADs) is device-induced thrombus formation due to inadequate blood-flow dynamics generated by the blood pump rotor. The latter is a highly complex device, with difficulties during conventional manufacturing through milling or casting. Therefore, the additive manufacturing technology relying on stereo-lithography (SLA) capable of producing parts of significantly increased freedom for a blood-flow-compatible, thrombus-risk-free design was chosen as novel and flexible technology for that type of application. However, as yet state-of-the-art SLA is not suitable to produce fully safe blood-contacting devices. Therefore, the present experiment covered chemical, mechanical, rheological, tribological, and complex biocompatibility characterization in accordance with i.a. ISO 10993 standards, including hemolysis and an acute thrombogenicity blood test on fresh animal blood (both as innovative laboratory tests to avoid animal usage in preclinical studies) with a special focus on testing demonstrators of miniaturized blood pump rotors. The conducted tests indicated acceptable biocompatibility of the material and a slight improvement in biocompatibility with surface modification. Additionally, a high biocompatibility of the tested materials was confirmed. Based on studies and simulations, stereolithography (SLA) as an additive manufacturing technology with significantly increased freedom for a blood-flow-compatible, thrombus-risk-free design was chosen as a novel and flexible technology basis in the 4DbloodROT project to enable future manufacturing of rotors with exceptional biomimetic complexity.