INTRAVASCULAR XRAY SOURCE FOR RESTENOSIS TREATMENT

该项目的目标是开发一种微型的、基于导管的x射线源，用于放射治疗，以防止经皮腔内血管成形术后再狭窄。30% - 50%的血管成形术患者在手术后6个月内会出现再狭窄。血管内放射治疗已被证明对预防或显著延缓冠状动脉和外周血管再狭窄有效。正在进行的血管内近距离放射治疗再狭窄的临床试验使用伽马或β发射放射性同位素通过引导导管输送到血管成形术部位，并在足够剂量的剂量输送到动脉段时退出。这些放射性装置有明显的缺点，包括剂量率有限，对病人和医务人员的安全危害，以及运输、储存和处置方面的限制。牛顿科学公司建议开发一种一次性的、电动的x射线源，它足够小，可以通过一个标准的引导导管到达血管成形术部位。所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图。此外，伴随使用放射性物质的监管和安全问题完全消除了。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微型源的可行性。建议的商业应用：全球每年约有1,000,000例冠状动脉成形术。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。一种灵活的、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for restenosis use gamma or beta-emitting radioisotopes delivered to the angioplasty site via a guide catheter and withdrawn when sufficient dose has been delivered to the arterial segment.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.