DESIGN SOFTWARE FOR CARDIOVASCULAR DEVICES

人造心血管装置的安全性和有效性关键取决于控制血液创伤和血栓形成的相互竞争的血液动力学因素。与使用计算流体动力学(CFD)等先进设计方法来优化空气动力学的航空航天行业不同，医疗器械行业没有类似的工具来优化血液动力学。拟议的项目将通过开发创新软件来满足这一需求，该软件将航空航天优化领域现有的最佳技术与心血管设备开发方面的技术相结合。由此产生的产品将实现心血管设备的自动化优化，将溶血和血栓形成降至最低。我们小组应用于旋转式心脏辅助装置的初步工作证明了这种设计方法的有效性。在第一阶段，我们建议简化、增强我们目前的设计流程，并将其整合到一个实用的计算机程序中。在第二阶段，将开发通用的、用户友好的商业级软件，用于设计和分析血液接触流体设备。该项目将为分析和优化心血管假体提供合理的基础，从而既可以预测设备引发的血液创伤，又可以将其降至最低。在商业上，拟议的软件将是市场上第一个专门为心血管设备行业设计的同类产品。建议的商业应用：该设计软件的潜在用户包括任何从事心血管设备开发的个人、团体或公司。市场可能会从医疗应用扩展到几乎所有涉及计算流体力学设计的企业。由于这是同类产品中的第一款，Antakamatics乐观地预计，该软件将逐渐站稳脚跟，成为心血管设备开发商的卓越设计软件--就像Ansys、Patran、AUTOCAD等已经在汽车和航空航天行业变得无处不在一样。

The safety and efficacy of a prosthetic cardiovascular device critically depends on competing hemodynamic factors governing blood trauma and thrombosis. Unlike the aerospace industry which uses advanced design methods such as computational fluid dynamics (CFD) to optimize aerodynamics, the medical device industry has no analogous tool to optimize hemodynamics. The proposed project will address this need by developing innovative software that combines the best technologies available in aerospace optimization with those in cardiovascular device development. The resulting product will enable automated optimization of cardiovascular devices for minimal hemolysis and thrombogenicity. Preliminary work by our group applied to rotary cardiac-assist devices has demonstrated the effectiveness of this design approach. In Phase I, we propose to streamline, enhance and integrate our current design processes into a functional computer program. During Phase II, versatile, user-friendly commercial grade software for the design and analysis of blood-contacting fluid devices will be developed. The proposed project will provide a rational basis for analyzing and optimizing prosthetic cardiovascular devices such that device-induced blood trauma can be both predicted and minimized. Commercially, the proposed software will be the first product of its kind on the market specifically designed for the cardiovascular device industry. PROPOSED COMMERCIAL APPLICATIONS: The potential users of this design software include any individual, group, or company engaged in cardiovascular device development. The market may be extended beyond medical applications, to virtually all enterprises involving computational fluid dynamics design. Because this is the first product of its kind, Antakamatics optimistically envisions this software gradually gaining foothold as the pre-eminent design software for cardiovascular device developers -- much like ANSYS, Patran, AutoCAD, etc. have become ubiquitous in the automotive and aerospace industry.