Modern Design Software for Biomedical Devices

描述(由申请人提供)：成功的第一阶段SBIR项目开发了新技术，将使生物医学设备基于CFD的自动设计优化成为可能。该项目开发了创新的软件，将航空航天优化领域的最佳技术与心血管设备开发方面的技术相结合。第一阶段的工作清楚地证明了这种设计方法在应用于新的和现有的心脏辅助装置时的有效性。运行自动形状优化代码以最小化血液透析连接器中的血液溶血，并对结果进行实验验证。验证了计算的正确性和准确性，与实际实验数据吻合较好。并启动了基于CFD的下一代设计优化软件的设计与开发工作。达到或超过了所有第一阶段的目标，并建立了概念验证。在第二阶段，基于CFD的设计技术的生物医学意义将通过自动几何形状优化将临床现实生物医学设备中的溶血降至最低。还将全面实施专门为载血设备的设计和分析量身定做的方便用户的商业质量软件包。该设计软件的潜在用户包括任何从事生物医学设备开发的团体。该软件将是第一个将实用血液损伤模型纳入生物医疗设备分析和设计应用程序的商业产品。

DESCRIPTION (provided by applicant): The successful Phase I SBIR program has developed new technology that will enable automated CFD-based design optimization of biomedical devices. The project has developed innovative software that combines the best technologies available in aerospace optimization with those in cardiovascular device development. The Phase I work has clearly demonstrated the effectiveness of such a design approach when applied to new and existing cardiac-assist devices. An automated shape optimization code was run to minimize blood hemolysis in a hemodialysis connector and experimentally validated the results. The computation was verified as being correct and accurate and the agreement with actual experimental data is excellent. The design and development of next- generation CFD-based design optimization software was also started. All Phase I objectives were met or exceeded and proof-of-concept was established. In Phase II, the biomedical significance of the CFD-based design technology will be demonstrated by minimizing hemolysis in clinically realistic biomedical devices via automated geometry shape optimization. A user-friendly commercial-quality software package specifically customized for design and analysis of blood-carrying devices will also be fully implemented. The potential users of this design software include any group engaged in biomedical device development. The software will be the first commercial product to incorporate practical blood damage models for biomedical device analysis and design applications.