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用于原位血管内移植物开窗的新型电磁引导血管内器械

Novel EM Guided Endovascular Instrumentation for In Situ Endograft Fenestration.

作者信息

Condino S, Piazza R, Viglialoro R M, Mocellin D M, Turini G, Berchiolli R N, Micheletti F, Rossi F, Pini R, Ferrari V, Ferrari M

机构信息

1Information Engineering DepartmentUniversity of Pisa56122PisaItaly.

2EndoCAS CenterDepartment of Translational Research and New Technologies in Medicine and SurgeryUniversity of Pisa56126PisaItaly.

出版信息

IEEE J Transl Eng Health Med. 2020 Mar 4;8:1900208. doi: 10.1109/JTEHM.2020.2973973. eCollection 2020.

Abstract

This work aims at providing novel endovascular instrumentation to overcome current technical limitations of in situ endograft fenestration including challenges in targeting the fenestration site under fluoroscopic control and supplying mechanical support during endograft perforation. Novel electromagnetically trackable instruments were developed to facilitate the navigation of the fenestration device and its stabilization at the target site. In vitro trials were performed to preliminary evaluate the proposed instrumentation for the antegrade in situ fenestration of an aortic endograft, using a laser guidewire designed ad hoc and the sharp end of a commercial endovascular guidewire. In situ fenestration was successfully performed in 22 trials. A total of two laser tools were employed since an over bending of laser guidewire tip, due to its manufacturing, caused the damage of the sensor in the first device used. Preliminary in vitro trials demonstrate the feasibility of the proposed instrumentation which could widespread the procedure for in situ fenestration. The results obtained should be validated performing animal studies. Clinical Impact: The proposed instrumentation has the potential to expand indications for standard endovascular aneurysm repair to cases of acute syndromes.

摘要

这项工作旨在提供新型血管内器械,以克服当前原位血管内移植物开窗术的技术局限性,包括在荧光镜控制下靶向开窗部位以及在血管内移植物穿孔期间提供机械支撑方面的挑战。开发了新型电磁可跟踪器械,以促进开窗装置的导航及其在目标部位的稳定。进行了体外试验,以初步评估所提议的用于主动脉血管内移植物顺行原位开窗术的器械,使用了专门设计的激光导丝和商用血管内导丝的尖锐末端。在22次试验中成功进行了原位开窗术。总共使用了两种激光工具,因为由于制造原因,第一个使用的装置中激光导丝尖端过度弯曲导致传感器损坏。初步体外试验证明了所提议器械的可行性,这可能会推广原位开窗术。所获得的结果应通过进行动物研究来验证。临床影响:所提议的器械有可能将标准血管内动脉瘤修复的适应症扩大到急性综合征病例。

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