Multi-spectral Physiologic Visualization Imaging For Non-contact, Real-time Capture of Cardiovascular Vital Signs Using a Novel Optical Engineering Design

摘要 Covid大流行扰乱了医疗保健提供的方方面面。在这个新兴的新时代 病原体和耐药性，即使是平凡的和标准的护理做法现在也必须解释 患者/提供者交互的安全性。这一安全要求是中国尚未满足的迫切需要 临床医学。一个例子是使用常规的 手表、单点脉搏血氧计和血压计的交互监测(CIM)工具 诊所就诊的开始。这种数据捕获的遭遇现在将患者和提供者置于风险之中。 RFPI的突破性多光谱生理可视化(MSPV)是一种完全非接触、非 侵入性和非电离医学成像技术，提供：1)血流分布(流入 组织中的血管和灌注)视野(FOV)；2)二维周围血氧饱和度(2DSpO2) 3)心率、血压等心血管生理状态参数， 来自BFD成像元数据的心率-压力乘积、血流灌注变化等。这一分析 实时显示10-14秒的相干近红外激光和可见光 成像。MSPV的第一个临床形式因素，称为iCertainty™，已被美国食品和药物管理局批准用于开放手术。 先前的研究表明，MSPV数据达到或超过了当前临床实践数据标准 一致性、可变性和准确性。适用于临床的MSPV技术的外形尺寸将 消除这种遭遇风险，同时捕获更高质量的心血管生命体征数据，以便做出更好的决策- 提供和护理服务。 此第一阶段提案的目标是将MSPV患者的光学-组织界面重新设计为1.5-2.5厘米 工作距离(相机镜头到组织表面的距离)。这提出了许多光学工程和 设计挑战，因此RFPI将两个优秀的合作组织聚集在一起：Inov Inc.，一个 30年的光学设计和工程公司(客户从Inov的产品中获得超过5亿美元的收入 设计)，以及位于北卡罗来纳州达勒姆的领先医疗器械设计公司Nocuronal Product Development，LLC。 该提案的两个具体目标是：1)开发光学解决方案，以优化照明和 这一短小的WD带来的反射图像捕获挑战；和2)医疗级的原型构建 生理测定仪(MGPD)对50名成年志愿者的临床概念验证测试 在MSPV-NOED研究中，以确定与当前使用的CIM工具的一致性、可变性和准确性。 这些第一阶段的数据和该协作组织团队将快速转移到第二阶段的应用程序 旨在构建和测试临床MGPD外形因素，以供FDA提交。这项高度创新的技术 这种方法有可能影响患者和提供者的安全，以及生命体征数据的质量； 2018年，美国记录了4万个指定的门诊网站。

ABSTRACT All aspects of healthcare delivery have been disrupted by the Covid pandemic. In this emerging era of new pathogens and drug-resistance, even mundane and standard-of-care practices must now account for the safety of the patient / provider interaction. This safety requirement is an immediate unmet need in clinical medicine. An example is the process of capturing cardiovascular Vital Sign data using the Conventional Interactive Monitoring (CIM) tools of a wristwatch, a single-point pulse oximeter, and a sphygmomanometer at the beginning of the clinic visit. This data capture encounter now puts patients and providers at risk. RFPi’s groundbreaking Multi-spectral Physiologic Visualization (MSPV) is an entirely non-contact, non- invasive, and non-ionizing medical imaging technology that provides: 1) Blood Flow Distribution (flow in vessels AND perfusion in tissues) in the Field of View (FOV); 2) 2D peripheral oxygen saturation (2D SpO2) in tissues in the same FOV; and 3) cardiovascular physiologic status parameters of heart rate, blood pressure, rate-pressure product, perfusion variation, and others from the metadata of the BFD imaging. This analysis display is presented in immediate real-time from 10-14 seconds of coherent NIR laser and Visible light imaging. The first clinical form factor of MSPV, called iCertainty™, is FDA-approved for open surgical use. Prior studies have indicated that the MSPV data meet or exceed current clinical practice data standards for consistency, variability, and accuracy. A clinic-appropriate form factor of the MSPV technology would eliminate this encounter risk while capturing better quality cardiovascular Vital Sign data for better decision- making and care delivery. This Phase I proposal objective is to re-engineer the MSPV patient optics-tissue interface into a 1.5-2.5 cm working distance (camera lens to tissue surface distance). This presents a number of optics engineering and design challenges, so RFPi has brought together two outstanding Collaborating Organizations: INOV INC, a 30-year optics design and engineering firm (over $500 M in revenue generated by clients from INOV’s product designs), and Nocturnal Product Development, LLC, a leading medical device design company in Durham, NC. The two Specific Aims of the proposal are to: 1) Develop the optics solutions to optimize the Illumination and Reflectance Image Capture challenges resulting from this short WD; and 2) Prototype Build of a Medical Grade Physiology Determination (MGPD) device, with clinical proof-of-concept testing in 50 adult volunteer subjects in the MSPV-NOED Study to determine consistency, variability and accuracy vs. the CIM tools currently in use. These Phase I data and this Collaborating Organization team will quickly move to a Phase II application designed to build and test a clinical MGPD form factor for FDA submission. This highly innovative technology approach has the potential to impact patient and provider safety, as well as Vital Sign data quality, in the > 40,000 designated outpatient clinic sites in the United States documented in 2018.