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。虽然供体心脏的移植是最好的解决方案，但大多数情况下不适用于特定患者，但心室辅助装置（VAD）作为植入式轴流泵提供了保持患者存活的解决方案。由于供体器官的短缺，VAD往往成为患者的唯一解决方案，从而成为目的性治疗。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的设计存在血液成分剪切损伤的风险，但也存在由于金属泵组件血液相容性不足而导致的器械内血栓形成的风险。因此，该提案旨在由合作伙伴MIET开发一种名为SPUTNIK的新型轴向血泵，该泵应具有优化设计，以减少血液细胞和von Willebrandt因子的剪切损伤。由于钛合金制成的泵组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剂表面涂层，该涂层基于肝素的共价和吸附固定的组合。体外血液相容性应与人血成分进行研究，重点关注凝血和血小板活化。MIET将在模拟循环方法中研究新型轴流式血泵的血液动力学特性，该方法还将用于研究有关溶血、von Willenbrandt因子损伤、止血和血小板活化的血液损伤。泵几何结构和表面涂层的设计变更可能有助于改善长期血液相容性，这可能允许VAD在未来环境中作为慢性心力衰竭的目标治疗应用。

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.