Electrohydraulic impactor for peripheral arterial occlusion management

项目概要/摘要 本研究项目的主要目标是开发和临床前验证一种新型的电动液压 冲击（EHI）器械，将帮助临床医生治疗外周动脉慢性完全闭塞患者 （CTO）。CTO代表血管的完全阻塞，并且难以使用血管造影剂再通。 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尺寸和迂曲度是导致 治疗过程中出现多种并发症。因此，大量的CTO使用侵入性治疗。 旁路手术，其具有显著的发病率并且需要长时间的恢复。核心挑战是 基于导管的非手术经皮CTO治疗的另一个问题是， 钙化和抗血管成形术线的慢性阻塞。尽管已经努力利用 准分子激光器或旋切装置（旋转消融器），这些斑块修改装置需要金属丝 穿过CTO，如果没有建立导线交叉，则限制了它们的实用性。为了解决这个临床上重要的 困难的CTO交叉问题，物理科学公司。(PSI)与布里格姆和妇女组织合作， Hospital（BWH）和Impact Vascular（IVAS）提议开发一种新型且更安全的 一种CTO管理的方法和装置。所提出的装置使用电动液压冲击器， 几百巴的定向冲击压力穿透CTO斑块而不损坏正常弹性 动脉组织因此，EHI将有助于CTO通过和远端导丝通过， 用球囊和支架治疗。

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.