Virtual dose mapping for radiation sterilization

用于辐射灭菌的虚拟剂量图

• 批准号: 10541758
• 负责人: TOBIAS FUNK
• 金额: $ 19.89万
• 依托单位: TRIPLE RING TECHNOLOGIES, INC.
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-09-27 至 2023-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10541758
• 关键词: Virtual; dose; mapping; radiation; sterilization

Project Summary Because sterilization is often only considered after a medical device has been fully engineered and manufactured, the costs associated with failing to meet regulatory sterilization requirements are astronomical. In the best case, the sterilization configuration can be iteratively modified until the regulatory requirements are met. This is an expensive and time-consuming endeavor. However, it is still preferable to the worst cases of having to redesign parts of the device or abandoning the device all together. This “trial-and-error” approach is prevalent throughout all aspects of sterilization. As another example, when choosing between sterilization modalities, medical device companies often rely on rules-of-thumb which may lead to a suboptimal choice for their device. As such, the medical device industry needs a tool that will allow them to consider sterilization requirements early in the product development process, in the same way they would consider other engineering concerns such as thermal management, stress distributions, and environmental sensitivity. The incorporation of such a tool into the product development process will allow for a first-class consideration of medical device safety as it relates to sterilization, which has a positive impact on public health. This project proposes to fill this gap in the computer-aided engineering market by developing a simulation tool capable of predicting the outcome of radiation sterilization without having a fully engineered or manufactured product. From only the Computer Aided Design (CAD) model of the device, the proposed software will be able to calculate the full three-dimensional dose distribution that would be delivered during radiation sterilization. By leveraging the validated Monte Carlo library Geant4, and the scalability and flexibility of cloud computing, the simulation tool will be fast, accurate, and user-friendly. Developing such a simulation tool involves architecting and implementing a flexible cloud computing infrastructure and user-friendly web interface. Through both a series of internal verification tests and usability testing, this project will result in an accurate and verified cloud-based simulation tool for the medical device sterilization market.

项目摘要 因为通常只有在医疗器械完全设计完成后才考虑灭菌， 在制造过程中，与未能满足监管灭菌要求相关的成本是天文数字。 在最好的情况下，可以反复修改灭菌配置，直到满足法规要求。 met.这是一项昂贵且耗时的奋进。然而，它仍然比最坏的情况更好， 不得不重新设计设备的部件或一起放弃设备。 这种“试错法”在绝育的所有方面都很普遍。另一个例子，当 在灭菌方式之间进行选择时，医疗器械公司通常依赖于经验法则， 导致他们设备的次优选择。 因此，医疗器械行业需要一种工具，使他们能够考虑灭菌要求 在产品开发过程的早期，他们会以同样的方式考虑其他工程问题 例如热管理、应力分布和环境敏感性。这样的一个结合 产品开发过程中的工具将允许对医疗器械安全性进行一流的考虑， 与绝育有关，这对公众健康有积极影响。 该项目提议通过开发模拟工具来填补计算机辅助工程市场的这一空白 能够预测辐射灭菌的结果，而无需完全设计或制造 产品仅从设备的计算机辅助设计（CAD）模型，所提出的软件将能够 以计算在辐射灭菌期间将输送的全三维剂量分布。通过 利用经过验证的Monte Carlo库Geant 4以及云计算的可扩展性和灵活性， 模拟工具将是快速、准确和用户友好的。 开发这样的模拟工具涉及到架构和实现灵活的云计算 基础设施和用户友好的网络界面。通过一系列内部验证测试和可用性测试， 通过测试，该项目将为医疗器械提供一个准确且经过验证的基于云的模拟工具 消毒市场。