Objective: 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. Technology: 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. Results: 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. Conclusions: 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.

中文翻译：

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用于原位内移植开窗术的新型 EM 引导的血管内仪器

目的：这项工作旨在提供新型血管内器械，以克服目前原位内移植物开窗术的技术局限性，包括在透视控制下瞄准开窗部位和在内移植物穿孔期间提供机械支持方面的挑战。技术：开发了新型电磁可跟踪仪器，以促进开窗装置的导航及其在目标位置的稳定。使用专门设计的激光导丝和商用血管内导丝的尖端，进行了体外试验，以初步评估用于主动脉内移植物顺行原位开窗的拟议仪器。结果：在 22 项试验中成功地进行了原位开窗术。总共使用了两个激光工具，因为激光导丝尖端的过度弯曲，由于其制造，导致使用的第一个设备中的传感器损坏。结论：初步体外试验证明了所提议的仪器的可行性，该仪器可以推广原位开窗手术。获得的结果应经过动物研究的验证。临床影响：拟议的仪器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。获得的结果应经过动物研究的验证。临床影响：拟议的仪器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。获得的结果应经过动物研究的验证。临床影响：拟议的仪器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。