Modern Design Software for Biomedical Devices

描述（由申请人提供）：成功的第一阶段SBIR计划开发了新技术，将实现基于CFD的生物医学设备自动设计优化。该项目开发了创新软件，将航空航天优化领域的最佳技术与心血管设备开发领域的最佳技术相结合。第一阶段的工作已经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设备时的有效性。运行自动形状优化代码，以最大限度地减少血液透析连接器中的血液溶血，并通过实验验证结果。计算结果与实验数据吻合良好。新一代基于CFD的设计优化软件的设计和开发也已启动。第一阶段的所有目标均已达到或超过，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最大限度地减少临床实际生物医学设备中的溶血来证明。还将全面采用一套方便用户的商业质量软件包，专门用于设计和分析血液输送装置。该设计软件的潜在用户包括从事生物医学设备开发的任何团体。该软件将是第一个商业产品，将实际的血液损伤模型，用于生物医学设备的分析和设计应用。

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.