Advanced Modelling Platform with Moving Ventricular Walls for Increasing Speed to Market of Heart Pumps

左心辅助装置(LVAD)是辅助晚期心力衰竭(HF)患者的重要医疗器械。将创新的心脏泵推向市场是一个漫长的过程，通常需要10年时间。由于泵在其中运行的真实世界心血管系统(CS)的复杂性，以及在活体测试之前确定泵性能的当前分析工具的局限性，开发时间被延长。该项目将通过一种创新的LVAD和CS耦合模型消除这些限制，捕捉左心室(LV)和瓣膜开口的运动室壁(MVW)。了解LVAD如何在体内动物试验和严重心力衰竭(SHF)患者或恢复中的一系列生理脉动流动条件下工作，是成功推出LVAD的关键。通常动物模型在生理上与SHF患者显著不同，制造商使用其他技术，如计算流体动力学(CFD)和模拟循环(MLS)，以提供信心将VAD用于人体试验。通过了解生理学，可以在设备控制器中实施复杂的算法，以量身定制治疗并警告临床医生潜在的不良事件(AE)。通过合作，Calon为LVAD创建了强大的CFD建模能力，Calon开发了包含LVAD的零维(0D)数学CS模型。这使得Calon能够模拟泵中的流动，并分析脉动条件下的剪切应力、停留时间和血液损伤。我们已经用简单的模型证明了需要包括MVW，当流体进入泵入口时，MVW会扰乱流体。Calon将开发一个LV与MVW和泵的3D耦合CFD模型。0D模型将定义进出阀门的流量，这将形成CFD模型的边界条件。心脏的运动将从心脏成像中得出。0D模型将利用患者群体的数据进一步开发，使Calon能够更好地了解泵在现实流变学和生理学中的性能，这将最终提高LVAD的安全性。此外，卡隆将对产生的数据和可用的文献进行审查，以探索用于改善患者结果和帮助临床医生的算法。

Left Ventricular Assist Devices (LVADs) are vital medical devices in aiding patients with advanced Heart Failure (HF). Bringing innovative heart pumps to market is a lengthy process, typically taking \>10 years. Development times are extended due to the complexity of the real-world cardiovascular system (CS), in which the pump operates, and limitations in current analytical tools for determining pump performance prior to _in vivo_ testing. This project will remove these limitations with an innovative coupled LVAD and CS model, capturing the Moving Ventricular Wall (MVW) of the Left Ventricle (LV) and valve openings.Understanding how an LVAD works across the range of physiological pulsatile flow conditions expected for _in vivo_ animal tests and patients with Severe Heart Failure (SHF) or in recovery, is critical to the successful launch of an LVAD.Often animal models are significantly different physiologically from SHF patients and manufacturers use other techniques such as Computational Fluid Dynamics (CFD) and Mock Loops (MLs) to provide confidence to take a VAD to human trials. Understanding physiology allows complex algorithms to be implemented within the device controller to tailor treatments and warn clinicians of potential Adverse Events (AEs).Calon, through partnerships, has created a robust CFD modelling capability for LVADs and Calon has developed a zero-dimensional (0D) mathematical CS model, incorporating the LVAD. This allows Calon to simulate flows through the pump and analyse shear stress, residence time and blood damage in pulsatile conditions. We have shown, with simplistic models, the need to include MVWs, which perturbs the fluid as it enters the pump inlet.Calon will develop a 3D coupled CFD model of the LV with MVWs and the pump in situ. The 0D model will define the flow in and out of the valves, which will form the boundary conditions for the CFD model. The movement of the heart will be derived from cardiac imaging. The 0D model will befurther developed with data from patient populations, allowing Calon to better understand the performance of the pump in realistic rheology and physiology, which will ultimately improve the safety of the LVAD. Furthermore, Calon will conduct a review of the data generated and the available literature to explore algorithms used to improve patient outcomes and aid clinicians.