INTRAVASCULAR XRAY SOURCE FOR RESTENOSIS TREATMENT

该项目的目标是开发一种用于放射治疗的微型、基于导管的X射线源，以防止经皮血管腔内成形术后的再狭窄。30%至50%的血管成形术患者在手术后6个月内会受到再狭窄的影响。血管内放射治疗已被证明在预防或显著延缓冠状动脉和外周血管的再狭窄方面是有效的。正在进行的血管内再狭窄近距离放射治疗临床试验使用伽马或贝塔放射性同位素通过引导导管输送到血管成形术部位，当足够剂量的放射性同位素输送到动脉节段时退出。这些放射性设备有很大的缺点，包括有限的剂量率，对病人和医务人员的安全威胁，以及对运输、储存和处置的限制。牛顿科学公司计划开发一种一次性的电动X射线源，其体积足够小，可以通过标准的引导导管到达血管成形术部位。提出的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分布。此外，完全消除了与使用放射性材料相关的监管和安全问题。在第一阶段，将测试两项关键技术，以确定构建具有所需辐射剂量率和剂量-深度特性的超小型源的可行性。拟议的商业应用：全世界每年大约进行100万例冠状动脉血管成形术。如果放射治疗再狭窄在临床试验中被证明是有效的，这代表着基于导管的放射设备的巨大市场。灵活的、基于导管的X射线源在肿瘤学中也有许多潜在的应用。

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for restenosis use gamma or beta-emitting radioisotopes delivered to the angioplasty site via a guide catheter and withdrawn when sufficient dose has been delivered to the arterial segment.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.