AN INTRAVASCULAR X-RAY SOURCE FOR RESTENOSIS TREATMENT

描述(申请人摘要逐字)：本项目的目标是 开发一种微型、基于导管的X射线源用于放射治疗 预防经皮腔内血管成形术后再狭窄。血管再狭窄 影响30%至50%的血管成形术患者在6个月内 手术过程。血管内放射治疗已被证明是有效的。 在预防或显著延缓冠状动脉和冠状动脉再狭窄方面 周围血管。正在进行的血管内近距离放射治疗的临床试验 再狭窄使用伽马或贝塔发射的放射性同位素 血管成形术部位经导尿管，当足够的剂量 被输送到动脉节段。这些放射性装置有 重大缺陷，包括有限的剂量率和固定的剂量深度 简介、对患者和医务人员的安全危害以及对 运输、储存和处置。 在第一阶段，我们评估了开发一种一次性、 小到足以到达血管成形术部位的电动X射线源 通过标准的导尿管。建议的源的优势包括 开关能力、高辐射剂量率、用户可控剂量深度 简介，并消除随之而来的监管和安全问题 放射性物质的使用。第一阶段的结果证明了该方案的可行性 利用所需的辐射构建超小型X射线源 剂量率和剂量-深度特性。一个完全可操作的X射线源和 输送导管将在第二阶段开发，并在模体中进行测试。 建议的商业应用： 全世界大约有100万例冠状动脉成形术 每年。如果放射治疗再狭窄在临床试验中被证明有效，这 这代表了以导管为基础的辐射设备的巨大市场。一种灵活的以导管为基础的 X射线源在放射肿瘤学中也有许多潜在的应用。

DESCRIPTION (Applicant's abstract verbatim): 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 percent to 50 percent 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for restenosis use gamma or beta-emitting radioisotopes delivered to the angioplasty site via a guide catheter and withdrawn when sufficient dose has been delivered to the arterial segment.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 and fixed dose-depth profiles, safety hazards to patient and medical personnel, and restrictions on transportation, storage and disposal. In Phase I, we evaluated the feasibility of developing 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, user-controlled dose-depth profile, and elimination of the regulatory and safety issues that accompany the use of radioactive materials. The Phase I results demonstrate the feasibility of constructing an ultra-miniature X-ray source with the required radiation dose rate and dose-depth characteristics. A fully operational X-ray source and delivery catheter will be developed in Phase II and tested in phantoms. PROPOSED COMMERCIAL APPLICATION: 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 radiation oncology.