CORONARY STENTS WITH ION IMPLANTED RADIOACTIVITY

具有离子注入放射性的冠状动脉支架

• 批准号: 2424321
• 负责人: ANTHONY J ARMINI
• 金额: $ 9.99万
• 依托单位: IMPLANT SCIENCES CORPORATION
• 依托单位国家: 美国
• 财政年份: 1997
• 资助国家: 美国
• 起止时间: 1997-07-15 至 1998-01-14
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/2424321
• 关键词: biomaterial development /preparation; biomedical equipment development; phosphorus; radiological health; radiology; radionuclide implant; radionuclides; restenosis; silicon compounds; tissue support frame

In 1995 about one million people worldwide had fatty blockages in their coronary arteries opened by dilation. This procedure still results in a reclosure of the artery (restenosis) in about 30% of the cases despite the use of a tiny mesh supporting tube (stent) in the artery at the blockage site. Recently the exposure of the stent site to ionizing radiation has shown a marked inhibition of restenosis in animal and human studies. The technique with the lowest radiation dose to the patient is by using the radioisotope phosphorous-32 ion implanted into the stent itself. This isotope produces short-range radiation with a 14 day half-life which only affects the nearest tissues, rather than the entire body. Ion implantation burys the radioisotope below the surface of the stent, providing a safe, sealed product for the medical team handling the stent. Even though the FDA has authorized a 1200 patient study of the effects of phosphorous-32 ion implanted stents, no production facility presently exists in the U.S. to do the implantation. There are special safety hazards in generating radioactive ion beams using the techniques previously employed. We propose an innovative type of radioactive phosphorous source which consists of a sealed solid disk. Successful completion of Phase I and Phase II will produce a low cost technique to safely mass produce radioactive stents that will significantly improve the long term success rate of coronary angioplasty. PROPOSED COMMERCIAL APPLICATION This research will lead to the high volume ion implantation of coronary stents with radioactive P-32. Radioactive stents have been shown to markedly reduce restenosis after arthroplasty. Implant Sciences Corporation plans to offer the ion implantation as a service to stent manufactures.

1995年，全球约有100万人在他们的 通过扩张开放的冠状动脉。 此过程仍导致 尽管大约30％ 在动脉中使用微小的网状支撑管（支架） 阻塞站点。 最近，支架位点暴露于电离辐射已显示 动物和人类研究中对再狭窄的明显抑制作用。 这 对患者的辐射剂量最低的技术是使用 放射性同位素磷-32离子植入支架本身。 这 同位素可产生14天半衰期的短距离辐射 仅影响最近的组织，而不是整个身体。 离子 植入将放射性同位素掩埋在支架表面以下， 为医疗团队提供安全的密封产品 支架。 即使FDA已授权对效果进行1200个患者研究 磷酸32离子植入支架，目前没有生产设施 在美国存在植入。 有特殊安全 使用这些技术生成放射性离子光束的危害 先前雇用。 我们提出了一种创新的放射性类型 由密封的固体磁盘组成的磷源。 成功的 第一阶段和第二阶段的完成将产生低成本技术 安全质量产生放射性支架，将显着改善 冠状动脉成形术的长期成功率。 拟议的商业应用 这项研究将导致冠状动脉的大容量离子植入 带有放射性P-32的支架。 放射性支架已显示为 关节置换术后明显减少再狭窄。 植入科学 公司计划提供离子植入作为支架的服务 制成品。