非轴流可自动变形腔静脉滤器应用于预防肺动脉栓塞的研究

Pulmonary thrombo-embolism (PTE) is the one of significant causes of sudden death in clinic, which is mostly often believed as a complication of lower limb deep venous thrombosis. With a high mortality and effortless treatment, severe PTE can be simply and effectively prevented by Vena Cava Filters treatment. But the ugly situations, for which the current filters were prone to induce local thrombosis by interfering the caval hemodynamics, and as well as anticoagulation medicines for lifelong had potential bleeding complication, limited vena cava filter application in clinic. This suject is the further research of series study for automatically convertible filter by independent R & D. Previous studies successfully utilized degradable polymer materials constituted control structure to convert the filter structure to stenting structure in a certain condition after the filter was implanted in the body, the result had confirmed that the idea can effectively reduce of the hemodynamic interference by the filter. In this study, the degradable magnesium alloy material, with independent intellectual property rights, will be applied to construct the structural deformational control components. The new architecture created originally by our team is non-axial flow structure, which can further reduce the local hemodynamic interference especially when thrombus captured by filter than current used filter. The specially designed conoid structure and actiion by hemodynamics can lead the captured thrombus "moving " to vessel well, the thrombus can adhere to vessel well and trap as organized thrombus to avoid the risk of PTE by secondary thrombus dropping off after filter structure conversion. This study aimed to develop the revolutionarily novel filter to improve the clinical dilemma for the prevention of PTE and to accumulate experience of the application of degradable magnesium alloy material in clinics.

肺动脉栓塞（PTE）是临床猝死的重要病因之一，常继发于下肢深静脉血栓。重症PTE治疗困难，病死率高，腔静脉滤器预防PTE发生是最简单有效的措施。临床现有各种滤器对腔静脉血流动力学干扰大、易引起局部血栓、需长期服用抗凝药，使其应用受到限制。本课题是独立研发的可自动变形滤器序列研究的深化，在前期研究中，实现了利用可降解材料控制滤器植入体内后，一定条件下变形为支架样结构，有效减少了滤器结构对血流动力学干扰。本课题采用具有独立知识产权的、可降解镁合金材料构建结构变形控制组件，独创的非轴流结构进一步减少了血栓捕获后对局部血流动力学的干扰，特殊设计的锥形结构可以引导捕获血栓与血管壁发生粘连机化，避免滤器变形后二次脱落的风险。本研究目的是开发具有变革意义的新型滤器，改变目前临床预防PTE的困境，并积累可降解镁合金材料在生命科学应用的基础。

肺动脉栓塞（PTE）是临床猝死的重要病因之一，腔静脉滤器预防PTE发生是最有效的措施。临床现有各种滤器对腔静脉血流动力学干扰大、易引起局部血栓、需长期服用抗凝药。本课题是独立研发的可自动变形滤器设计了利用可降解材料控制滤器植入体内后，一定条件下变形为支架样结构，有效减少了滤器结构对血流动力学干扰。本课题拟采用具有独立知识产权的、可降解镁合金材料构建结构变形控制组件，设计非轴流结构减少对局部血流动力学的干扰，锥形结构可以引导捕获血栓与血管壁发生粘连机化。研究结果证实，简单的滤器结构对腔静脉血流动力学有明显干扰，本研究所开发的非轴流滤器结构，在此方面有明显的优势。经体外和计算机模拟证实，非对称结构捕获血栓有较好效率，且可以诱导血栓同血管壁的粘连。镁合金具有较好的物理特性和可生物降解特性，但加工性质条件高，需深化研究。在体内长期残留的支架样结构经过长期饲养证实可以完全内膜化，不干扰血流动力学。研究结果表明，本研究的方向和技术既有前景，应逐步深化。