Mechanical Engineering Practice, Exponent, Inc., 1075 Worcester St, Natick, MA, 01760, USA.
Mechanical Engineering Practice, Exponent, Inc., 149 Commonwealth Drive, Menlo Park, CA, 94025, USA.
Cardiovasc Eng Technol. 2021 Aug;12(4):387-397. doi: 10.1007/s13239-021-00538-7. Epub 2021 Apr 13.
Accelerating development of new therapeutic cardiac devices remains a clinical and technical priority. High-performance computing and the emergence of functional and complex in silico models of human anatomy can be an engine to accelerate the commercialization of innovative, safe, and effective devices.
An existing three-dimensional, nonlinear model of a human heart with flow boundary conditions was evaluated. Its muscular tissues were exercised using electrophysiological boundary conditions, creating a dynamic, electro-mechanical simulation of the kinetics of the human heart. Anatomic metrics were selected to characterize the functional biofidelity of the model based on their significance to the design of cardiac devices. The model output was queried through the cardiac cycle and compared to in vivo literature values.
For the kinematics of mitral and aortic valves and curvature of coronary vessels, the model's performance was at or above the 95th percentile range of the in vivo data from large patient cohorts. One exception was the kinematics of the tricuspid valve. The model's mechanical use environment would subject devices to generally conservative use conditions.
This conservative simulated use environment for heart-based medical devices, and its judicious application in the evaluation of medical devices is justified, but careful interpretation of the results is encouraged.
加速新型治疗性心脏设备的开发仍然是临床和技术上的优先事项。高性能计算和人类解剖功能复杂的计算模型的出现，可以成为加速创新、安全、有效的设备商业化的引擎。
评估了一个现有的具有流动边界条件的人类心脏三维非线性模型。使用电生理边界条件对其肌肉组织进行了锻炼，创建了人类心脏动力学的动态机电模拟。选择解剖学指标来根据它们对心脏设备设计的重要性来描述模型的功能生物保真度。通过心脏周期查询模型输出，并将其与体内文献值进行比较。
对于二尖瓣和主动脉瓣的运动学以及冠状血管的曲率，该模型的性能在大型患者队列的体内数据的第 95 百分位范围内或以上。一个例外是三尖瓣的运动学。该模型的机械使用环境将使设备处于普遍保守的使用条件下。
这种基于心脏的医疗设备的保守模拟使用环境及其在医疗设备评估中的合理应用是合理的，但鼓励对结果进行仔细解释。
