INTRAVASCULAR XRAY SOURCE FOR RESTENOSIS TREATMENT

用于再狭窄治疗的血管内 X 射线源

基本信息

批准号：
2873895
负责人：
RUTH E SHEFER
金额：
$ 10万
依托单位：
NEWTON SCIENTIFIC, INC.
依托单位国家：
美国
项目类别：
财政年份：
1999
资助国家：
美国
起止时间：
1999-05-01 至 2000-12-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/2873895
关键词：
X ray biomedical equipment development catheterization disease /disorder prevention /control energy source intraluminal angioplasty miniature biomedical equipment radiation dosage radiation therapy restenosis

项目摘要

The goal of this project is to develop a miniature, catheter-based X-ray source for radiation therapy to prevent restenosis after percutaneous transluminal angioplasty. Restenosis affects 30% to 50% of angioplasty patients within six months of the procedure. Intravascular radiation therapy has been shown to be effective in preventing or significantly delaying restenosis in both coronary and peripheral vessels. Ongoing clinical trials of intravascular brachytherapy for restenosis use gamma or beta-emitting radioisotopes delivered to the angioplasty site via a guide catheter and withdrawn when sufficient dose has been delivered to the arterial segment. These radioactive devices have significant drawbacks, including limited dose rates, safety hazards to patient and medical personnel, and restrictions on transportation, storage and disposal. Newton Scientific Inc. proposes to develop a disposable, electrically- powered X-ray source small enough to reach the angioplasty site through a standard guide catheter. Advantages of the proposed source include on-off capability, high radiation dose rate, and user-controlled dose-depth profile. Moreover, the regulatory and safety issues that accompany the use of radioactive materials are eliminated completely. In Phase I, two key technologies will be tested to determine the feasibility of constructing an ultra-miniature source with the required radiation dose rate and dose-depth characteristics. PROPOSED COMMERCIAL APPLICATIONS: Approximately 1,000,000 coronary angioplasty procedures are performed worldwide each year. If radiation therapy for restenosis is proven effective in clinical trials, this represents a large market for catheter-based radiation devices. A flexible, catheter-based X-ray source also has many potential applications in oncology.

该项目的目的是开发一种基于导管的X射线疗法，以防止经皮易流动性血管成形术后再狭窄。再狭窄在手术后六个月内影响30％至50％的血管成形术患者。血管内辐射疗法已显示可有效预防或显着延迟冠状动脉和外围血管的再狭窄。正在进行的血管内尿治疗的临床试验用于再狭窄的病使用伽马或发射β发射放射性异位素，该试验通过导管输送到血管成形术部位并在将足够剂量递送到动脉段时撤回。这些放射性设备具有明显的缺点，包括有限的剂量率，对患者和医务人员的安全危害以及对运输，存储和处置的限制。牛顿科学公司（Newton Scientific Inc.）建议开发一次性，电力的X射线源，足够小，可以通过标准导管到达血管成形术位点。所提出的来源的优点包括开关能力，高辐射剂量率和用户控制的剂量深度概况。此外，完全消除了使用放射性材料的法规和安全问题。在第一阶段，将测试两种关键技术，以确定构建具有所需辐射剂量率和剂量深度特征的超米底源的可行性。拟议的商业应用：每年在全球范围内进行大约1,000,000个冠状动脉血管成形术程序。如果证明对再狭窄的放射治疗在临床试验中有效，则代表了基于导管的辐射装置的大型市场。灵活的，基于导管的X射线源在肿瘤学中也具有许多潜在的应用。