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.

项目摘要/摘要该研究项目的主要目标是开发和链式验证一种新型的电液压撞击（EHI）设备将有助于临床医生治疗外周动脉慢性全部闭塞患者（CTO）。 CTO代表血管的完全阻塞，很难使用传统的经皮易流血管成形术（PTA）技术和设备。存在 CTO内的钙化和纤维化组织以及容器的大小和曲折的原因是治疗过程中多个并发症。因此，使用侵入性处理大量的CTO 旁路手术，具有明显的发病率，需要大量的恢复时间。核心挑战基于导管的非外科经皮CTO治疗是，越过用血管成形术线钙化和抗性慢性阻塞。尽管已经努力使用准分子激光器或旋转动脉切除术设备（旋转器），这些斑块修饰设备需要电线越过CTO，如果没有建立电线交叉，则可以限制其效用。解决这个临床重要的 CTO Crossing困难的问题，物理科学公司（PSI）与Brigham和妇女合作医院（BWH）和撞击血管（IVA）提议开发和临时评估新颖，更安全 CTO管理的方法和设备。所提出的设备使用产生的电液压撞击器几百个棒的撞击压力，可以穿透CTO牌匾，而不会损害正常弹性动脉组织。因此，EHI将促进CTO交叉和远端导线通道以实现确定性用气球和支架处理。