Electrohydraulic impactor for peripheral arterial occlusion management

项目摘要/摘要 本研究项目的主要目的是开发一种新型电液压源并进行临床前验证。 将帮助临床医生治疗外周动脉慢性完全闭塞患者的冲击(EHI)设备 (首席技术官)。CTO代表血管的完全堵塞，很难用 传统的经皮腔内血管成形术(PTA)技术和设备。.的存在 CTO内的钙化和纤维化组织，以及血管的大小和弯曲是导致 治疗过程中出现多种并发症。因此，相当数量的CTO使用侵入性治疗 搭桥手术，这种手术发病率很高，需要很长的恢复时间。主要的挑战是 基于导管的非手术经皮CTO治疗通常是令人难以置信的困难跨越 用血管成形术钢丝钙化和抵抗慢性阻塞。尽管已经做出了努力使用 准分子激光或旋转式动脉粥样硬化装置(旋转装置)，这些斑块修改装置需要一根钢丝 穿过CTO，如果没有建立导线交叉，这将限制它们的使用。为了解决这一临床上的重要问题 难以跨越的CTO问题，物理科学公司(PSI)与布里格姆和妇女协会合作 医院(BWH)和冲击血管(IVAS)建议开发和临床前评估一种新的更安全的 一种CTO管理的方法和装置。建议的装置使用电液冲击器，它可以产生 几百巴的定向冲击压力，以穿透CTO斑块而不破坏正常弹性 动脉组织。因此，EHI将促进CTO交叉和远端导丝通过，以实现最终的 用气囊和支架治疗。

Project Summary/Abstract The primary goal of this research project is to develop and pre-clinically validate a novel electrohydraulic impact (EHI) device that will aid clinicians in treating patients with peripheral artery chronic total occlusions (CTOs). CTOs represent the complete blockage of the blood vessels and are difficult to recanalize using traditional percutaneous transluminal angioplasty (PTA) techniques and apparatus. The presence of calcifications and fibrotic tissues within CTOs, together with the vessel size and tortuosity, are the causes of multiple complications during treatment. Therefore, a significant number of CTOs are treated using an invasive bypass surgery, which has significant morbidity and requires extensive recovery time. The central challenge to catheter based nonsurgical percutaneous CTO treatment is that it often is incredibly difficult to cross the calcified and resistant chronic blockage with an angioplasty wire. Although efforts have been made to use excimer lasers or rotational atherectomy devices (rotablator), these plaque modification devices require a wire to cross the CTO, which limits their utility if no wire crossing is established. To address this clinically important problem of difficult CTO crossing, Physical Sciences Inc. (PSI) in collaboration with Brigham and Women's Hospital (BWH) and Impact Vascular (IVAS) proposes to develop and pre-clinically evaluate a novel and safer method and device for CTO management. The proposed device uses an electrohydraulic impactor that creates a directed impact pressure of several hundred bar to penetrate the CTO plaque without damaging normal elastic arterial tissue. Therefore, EHI will facilitate CTO crossing and distal guide-wire passage to enable definitive treatment with balloons and stents.