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

使用新颖的光学工程设计非接触式实时捕获心血管生命体征的多光谱生理可视化成像

• 批准号: 10324829
• 负责人: Thomas Bruce Ferguson
• 金额: $ 25.96万
• 依托单位: RFPI, LLC
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-09-21 至 2023-06-20
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10324829
• 关键词: Address; Adult; Ambulatory Care Facilities; Architecture; Award; Blood Pressure; Blood flow; Businesses; COVID-19 pandemic; Cardiovascular system; Client; Clinic; Clinic Visits; Clinical; Clinical Medicine; Computer software; Data; Data Files; Decision Making; Development; Devices; Drug resistance; Engineering; FDA approved; Generations; Grant; Heart Rate; Image; Imaging technology; Individual; Lasers; Lighting; Medical; Medical Device Designs; Medical Imaging; Metadata; Monitor; Operative Surgical Procedures; Optics; Oxygen; Patient Care; Patients; Perfusion; Peripheral; Phase; Physiologic pulse; Physiological; Physiology; Process; Provider; Risk; Safety; Series; Site; Small Business Technology Transfer Research; Sphygmomanometers; Surface; Surgeon; Technology; Testing; Time; Tissues; United States; Variant; Visible Radiation; Visualization; care delivery; clinical application; clinical decision-making; clinical practice; commercialization; coronavirus disease; data quality; data standards; data visualization; design; emerging pathogen; engineering design; experience; health care delivery; heart rate variability; image visualization; improved; indexing; innovation; innovative technologies; lens; novel; novel therapeutics; patient safety; patient-provider contact; pressure; product development; prototype; sensor; standard of care; tool; trend; volunteer

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.

抽象的 在这个新兴的新时代，医疗保健服务的各个方面都受到了新冠疫情的干扰。 病原体和耐药性，甚至是普通的标准护理实践现在也必须考虑到 患者/提供者互动的安全性是当前未满足的需求。 一个例子是使用传统方法捕获心血管生命体征数据的过程。 手表、单点脉搏血氧计和血压计的交互式监测 (CIM) 工具 现在，这种数据采集过程将患者和提供者置于危险之中。 RFPi 的突破性多光谱生理可视化 (MSPV) 是一种完全非接触式、非接触式的 侵入性非电离医学成像技术可提供： 1) 血流分布（血流分布） 视野 (FOV) 中的血管和组织灌注 2) 中的 2D 外周血氧饱和度 (2D SpO2)； 同一视场中的组织；3) 心率、血压等心血管生理状态参数； 速率-压力乘积、灌注变化以及 BFD 成像元数据中的其他内容。 显示从 10-14 秒的相干近红外激光和可见光中立即实时呈现 MSPV 的第一个临床形式称为 iCertainty™，已获得 FDA 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的临床实践数据标准 MSPV 技术的一致性、可变性和准确性。 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做出更好的决策 - 制作和护理服务。 该第一阶段提案的目标是将 MSPV 患者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技术。 设计挑战，因此 RFPi 汇集了两个杰出的合作组织：INOV INC，一家 拥有 30 年历史的光学设计和工程公司（客户从 INOV 的产品中获得的收入超过 5 亿美元） 设计），以及位于北卡罗来纳州达勒姆的领先医疗设备设计公司 Nocturnal 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 短 WD 带来的反射图像捕获挑战；以及 2) 医疗级原型构建 生理学测定 (MGPD) 设备，在 50 名成年志愿者受试者中进行了临床概念验证测试 在 MSPV-NOED 研究中确定与当前使用的 CIM 工具的一致性、可变性和准确性。 这些第一阶段的数据和这个合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 形状因子，以供 FDA 提交这种高度创新的技术。 方法有可能影响患者和提供者的安全以及生命体征数据质量，> 2018 年，美国记录了 40,000 个指定门诊诊所地点。