Improved blood compatibility of rotary blood pump Sputnik by new design and novel anticoagulant surface coatings

急性和慢性心力衰竭是欧洲联盟以及俄罗斯联邦现代医学面临的主要挑战。虽然供体心脏移植是最好的解决方案，但大多不适用于特定患者，心室辅助装置（VAD）作为植入式轴流泵提供了维持患者生命的解决方案。由于供体器官的短缺，VAD往往成为患者的唯一解决方案，因此是目的地治疗。长期应用VAD需要全身抗凝，这降低了血栓形成的风险，但增加了出血的风险。此外，VAD的设计存在剪切损伤血液部件的风险，也存在金属泵部件血液相容性不足导致装置内血栓形成的风险。因此，该提案寻求由合作伙伴MIET开发一种名为SPUTNIK的新型轴向血泵，该泵应具有优化设计，以减少剪切引起的血细胞损伤和血管性血友病因子。由于钛合金泵部件的血液相容性需要改进，合作伙伴MLU将开发一种新的耐用抗凝表面涂层，该涂层基于肝素的共价和吸附固定相结合。以凝血和血小板活化为重点，研究与人血成分的体外血液相容性。新型轴向血泵的血流动力学特性将通过MIET在模拟循环方法中进行研究，该方法也将用于研究血液损伤，包括溶血、von Willenbrandt因子损伤、止血和血小板活化。泵的几何形状和表面涂层的设计变化可能有助于改善长期血液相容性，这可能使VAD在未来的设置中作为慢性心力衰竭的目的治疗。

Acute and chronic heart failure are major challenges in modern medicine in the European Union, but also in the Russian Federation. While transplantation of donor hearts is the best solutions, but mostly not available for a specific patient, ventricular assist devices (VAD) as implantable axial pumps have provided solutions to keep patients alive. Because of the shortage of donor organs, VAD become often the only solution for patients and hence a destination therapy. Long-term application of VAD requires systemic anticoagulation, which decreases the risk of thrombosis but increases that of bleeding. Moreover, the design of VAD bears risk of shear-induced damage of blood components, but also in-device thrombosis due to insufficient blood compatibility of metallic pump components. Hence, the proposal seeks to develop a new axial blood pump called SPUTNIK by the partner MIET that shall possess an optimized design to reduce shear-induced damage of blood cells and von Willebrandt factor. Since the blood compatibility of pump components made of titanium alloys needs to be improved, the partner MLU will develop a new durable anticoagulant surface coating that is based on a combination of covalently and adsorptive immobilization of heparin. The in vitro blood compatibility shall be studied with human blood components focusing on coagulation and platelet activation. The hemodynamic properties of the novel axial blood pump will be studied by MIET in a mock circulation approach that will also serve to study blood damage regarding hemolysis, von Willenbrandt factor damage, hemostasis and platelet activation. Design changes of pump geometry and surface coatings may contribute to an improved long-term blood compatibility that may permit VAD application in future settings as destination therapy in chronic heart failure.