NSF/FDA SIR: Real-Time Simulations of Electrical Activity of the Heart and Augmented/Virtual Reality for Medical Device Applications

NSF/FDA SIR：心脏电活动的实时模拟以及医疗设备应用的增强/虚拟现实

• 批准号: 2037894
• 负责人: Flavio Fenton
• 金额: $ 10万
• 依托单位: Georgia Tech Research Corporation
• 依托单位国家: 美国
• 项目类别: Standard Grant
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-01-01 至 2022-12-31
• 项目状态: 已结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=2037894&HistoricalAwards=false
• 关键词: NSF; FDA; SIR; Real; Time

There is a major transformation shift occurring in healthcare resulting from a number of factors including, genome sequencing, patient-specific approaches, and major digital technology advances. The FDA is responsible for the safety and efficacy of all medical products in the US, and its Center for Devices and Radiological Health (CDRH) is responsible for the oversight of ~175,000 devices including nearly 100 novel Pre-Market Approvals (PMAs) per year. FDA, and CDRH in particular, has been pro-active in regard to innovative technology as evident by the release of “Guidance Documents,” Standards, and a major “Digital Health” initiative. The Digital Health initiative includes “Software as a Medical Device, Advanced Analytics, Artificial Intelligence, Cloud Computing, Cybersecurity, Interoperability, Medical Deice Data System, Mobile Medical Aps, and Wireless and Novel Technology. The goal of this one year NSF/FDA Scholar-in-Residence project is to expand these efforts by: 1) catalyzing the ongoing efforts of CDRH regarding Augmented Realty (AR) and Virtual Reality (VR); and 2) develop a novel hardware and software ‘platform’ to address certain devices incorporating BOTH AR/VR and real-time simulations. This new testbed will be housed at FDA and include an “exemplar device” to represent the dynamics within of a “cardiac electrophysiology test” performed in patients. As part of outreach and public dissemination, the software developed for the VR/AR testbed will be made freely available to the public. Developments for the testbed will include an interactive, “walkable” 3D virtual museum and interactive educational simulations about the heart for clinicians, their patients and the public in general to visualize heart dynamics, arrhythmias and existing treatments/therapies. The goal of this project is to help create an infrastructure critically needed by the FDA to evaluate and validate in silico studies and VR/AR systems intended to explore new approaches for visualization and manipulation of cardiovascular anatomies, including electrical wave propagations and strategical planning of invasive procedures used in the clinic as well as anti-arrhythmic drug design. While high performance computer simulations of complex physiological and biological models and VR/AR visualization of biological and medical systems have been done in the past, this is believed to be the first time the two are merged to be simulated and made interactive at the same time. The in-real-time testbed developed will allow the FDA to study interaction of devices and simulations in the loop with patients in the clinic. To achieve this goal, the research plan is organized under three aims: (1) Incorporate interactive real-time simulations of complex mathematical cell models in accurate realistic 3D cardiac structures, and develop a framework for visualization and interaction with these models in VR and AR on a desktop computer to eliminate the need for supercomputer simulations; (2) Develop a large catalogue of electrophysiological and structural models to run under this interactive VR/AR framework from aim 1; and (3) Develop online resources for medical doctors, patients and general public, to explain the heart’s function, heart arrhythmias as some of the methods currently used for control and termination of arrhythmias using the VR/AR testbed. The infrastructure developed will enable the FDA to be proactive and prepared to address the complex regulatory issues introduced by these emergent advanced technologies, which is particularly relevant for cardiac electrophysiological devices because the most dangerous arrhythmias involve complex spatio-temporal patterns that are recorded with limited spatial resolution using cardiac mapping catheters during a cardiac electrophysiological test.This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.

由于基因组测序、针对患者的方法和重大数字技术进步等多种因素，医疗保健领域正在发生重大转变。 FDA 负责美国所有医疗产品的安全性和有效性，其设备和放射健康中心 (CDRH) 每年负责监督约 175,000 种设备，其中包括近 100 种新型上市前批准 (PMA)。 FDA，特别是 CDRH，在创新技术方面一直积极主动，发布的“指导文件”、标准和一项重大的“数字健康”举措就证明了这一点。数字健康计划包括“软件作为医疗设备、高级分析、人工智能、云计算、网络安全、互操作性、医疗设备数据系统、移动医疗应用程序以及无线和新技术。这一为期一年的 NSF/FDA 常驻学者项目的目标是通过以下方式扩大这些努力：1) 促进 CDRH 在增强现实 (AR) 和虚拟现实 (VR) 方面的持续努力；2) 开发一种新颖的硬件和软件“平台”来解决某些结合 AR/VR 和实时模拟的设备。这个新的测试台将设在 FDA 内，并包括一个“示例设备”，用于代表在患者中进行的“心脏电生理学测试”的动态。 作为推广和公共传播的一部分，为 VR/AR 测试平台开发的软件将免费向公众开放。测试平台的开发将包括交互式、 “可步行”3D 虚拟博物馆和关于心脏的交互式教育模拟，供临床医生、患者和公众直观地了解心脏动态、心律失常和现有治疗/疗法。该项目的目标是帮助创建 FDA 急需的基础设施，以评估和验证计算机研究和 VR/AR 系统，旨在探索心血管可视化和操纵的新方法 解剖学，包括电波传播和临床使用的侵入性手术的战略规划以及抗心律失常药物的设计。虽然过去已经完成了复杂生理和生物模型的高性能计算机模拟以及生物和医疗系统的 VR/AR 可视化，但这被认为是第一次将两者合并起来进行模拟并同时进行交互。开发的实时测试平台将允许 FDA 进行研究 设备和模拟在诊所与患者的循环交互。 为了实现这一目标，该研究计划分为三个目标：（1）将复杂数学细胞模型的交互式实时模拟融入精确的真实3D心脏结构中，并开发一个在桌面计算机上的VR和AR中与这些模型可视化和交互的框架，以消除对超级计算机模拟的需要； (2) 建立电生理学大目录 以及在目标 1 的交互式 VR/AR 框架下运行的结构模型； (3) 为医生、患者和公众开发在线资源，利用 VR/AR 测试平台解释心脏功能、心律失常等目前用于控制和终止心律失常的一些方法。开发的基础设施将使 FDA 能够积极主动并准备好解决这些新兴先进技术带来的复杂监管问题， 这与心脏电生理设备特别相关，因为最危险的心律失常涉及复杂的时空模式，这些模式是在心脏电生理测试期间使用心脏标测导管以有限的空间分辨率记录的。该奖项反映了 NSF 的法定使命，并通过使用基金会的智力价值和更广泛的影响审查标准进行评估，被认为值得支持。

项目成果

Optical Ultrastructure of Cardiac Tissue Helps to Reproduce Discordant Alternans by In Silico Data Assimilation

心脏组织的光学超微结构有助于通过计算机数据同化再现不一致的交替序列

• DOI: 10.1109/esgco55423.2022.9931369
• 发表时间: 2022
• 期刊: 2022 12th Conference of the European Study Group on Cardiovascular Oscillations (ESGCO
• 作者: Horning, Marcel;Loppini, Alessandro;Erhardt, Julia;Fenton, Flavio H.;Filippi, Simonetta;Gizzi, Alessio
• 通讯作者: Gizzi, Alessio

Voltage-mediated mechanism for calcium wave synchronization and arrhythmogenesis in atrial tissue

• DOI: 10.1016/j.bpj.2021.12.040
• 发表时间: 2022-02-01
• 期刊: BIOPHYSICAL JOURNAL
• 影响因子: 3.4
• 作者: Greene, D'Artagnan;Kaboudian, Abouzar;Shiferaw, Yohannes
• 通讯作者: Shiferaw, Yohannes