Electrohydraulic impactor for peripheral arterial occlusion management

用于外周动脉闭塞治疗的电动液压冲击器

基本信息

批准号：
10256269
负责人：
NICUSOR IFTIMIA
金额：
$ 26.31万
依托单位：
PHYSICAL SCIENCES, INC
依托单位国家：
美国
项目类别：
财政年份：
2021
资助国家：
美国
起止时间：
2021-04-01 至 2024-03-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10256269
关键词：
Address American Amputation Angioplasty Animals Arterial Occlusive Diseases Arteries Atherectomy Balloon Angioplasty Biliary calculi Blood Vessels Blood flow Bypass Cadaver Catheters Chronic Clinical Collaborations Complex Consult Development Device or Instrument Development Devices Diagnostic radiologic examination Disease Dissection Distal Doctor of Philosophy Effectiveness Electrical Engineering Electrodes Future Goals Grant Histology Hospitals Human Impairment Intervention Investigation Laboratories Lasers Leg Lesion Limb structure Lithotripsy Measurement Mechanics Medical Device Medical Device Designs Medical Records Methods Modeling Modification Morbidity - disease rate Operative Surgical Procedures Optical Coherence Tomography Pain in lower limb Patient-Focused Outcomes Patients Perforation Performance Perfusion Peripheral Peripheral arterial disease Phase Physicians Procedures Process Recovery Research Research Project Grants Resistance Resources Risk Rotational Atherectomies Stenosis Stents Techniques Technology Testing Time Tissues Ureterolithiasis Woman artery occlusion base calcification chronic ulcer commercialization design effective therapy experience experimental study foot improved in vivo evaluation insight limb amputation limb ischemia limb loss medical schools member necrotic tissue novel physical science pre-clinical pressure prevent programs research clinical testing success technology development tool

项目摘要

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.

项目概要/摘要该研究项目的主要目标是开发并进行临床前验证一种新型电动液压装置冲击 (EHI) 装置将帮助临床医生治疗外周动脉慢性完全闭塞患者（首席技术官）。 CTO 代表血管完全堵塞，很难使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，以及血管大小和弯曲度，是导致治疗期间出现多种并发症。因此，大量 CTO 接受侵入性治疗搭桥手术的发病率很高，并且需要很长的恢复时间。主要挑战是基于导管的非手术经皮 CTO 治疗的缺点是通常很难跨越用血管成形术丝治疗钙化且顽固的慢性阻塞。尽管已经努力使用准分子激光器或旋磨设备（旋转器），这些斑块修改设备需要一根电线跨越 CTO，如果没有建立电线交叉，就会限制其效用。为了解决这个临床上重要的问题物理科学公司 (PSI) 与布莱根妇女医院合作解决了 CTO 穿越困难的问题医院 (BWH) 和影响血管 (IVAS) 提议开发一种新型且更安全的药物并进行临床前评估一种CTO管理方法及装置。所提出的装置使用电动液压冲击器来产生数百巴的定向冲击压力可穿透 CTO 斑块而不损坏正常弹性动脉组织。因此，EHI 将促进 CTO 交叉和远端导丝通道，以实现明确的用球囊和支架治疗。