AN INTRAVASCULAR X-RAY SOURCE FOR RESTENOSIS TREATMENT

用于再狭窄治疗的血管内 X 射线源

• 批准号: 6499004
• 负责人: RUTH E SHEFER
• 金额: $ 45.14万
• 依托单位: NEWTON SCIENTIFIC, INC.
• 依托单位国家: 美国
• 财政年份: 1999
• 资助国家: 美国
• 起止时间: 1999-05-01 至 2005-01-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6499004
• 关键词: X ray; biomedical equipment development; catheterization; coronary artery; coronary disorder; disease /disorder prevention /control; energy source; intraluminal angioplasty; miniature biomedical equipment; phantom model; radiation dosage; radiation therapy; restenosis

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for restenosis use gamma or beta-emitting radioisotopes delivered to the angioplasty site via a guide catheter and withdrawn when sufficient dose has been delivered to the arterial segment.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

描述（申请人的逐字摘要）：该项目的目标是 开发一种用于放射治疗的微型导管式 X 射线源 预防经皮腔内血管成形术后再狭窄。再狭窄 六个月内影响 30% 至 50% 的血管成形术患者 程序。血管内放射治疗已被证明是有效的 预防或显着延迟冠状动脉和冠状动脉的再狭窄 周围血管。正在进行的血管内近距离放射治疗临床试验 再狭窄使用发射γ或β的放射性同位素传递到 通过引导导管进入血管成形术部位，并在剂量足够时撤回 被输送到动脉段。这些放射性装置具有 显着的缺点，包括有限的剂量率和固定的剂量深度 概况、对患者和医务人员的安全隐患以及限制 运输、储存和处置。 在第一阶段，我们评估了开发一次性、 电动 X 射线源足够小，可以到达血管成形术部位 通过标准引导导管。所提议来源的优点包括 开关能力、高辐射剂量率、用户控制的剂量深度 轮廓，并消除伴随的监管和安全问题 使用放射性材料。一期结果证明可行性 构建具有所需辐射的超小型 X 射线源 剂量率和剂量深度特征。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体模中进行测试。 拟议的商业应用： 全球大约进行了 1,000,000 例冠状动脉血管成形术 每年。 如果放射治疗在临床试验中被证明对再狭窄有效，那么这 代表了基于导管的辐射设备的巨大市场。 一种灵活的、基于导管的 X射线源在放射肿瘤学中也有许多潜在的应用。