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.

摘要 新型冠状病毒疫情扰乱了医疗服务的各个方面。在这个新兴的时代， 病原体和耐药性，即使是普通的和标准的护理实践，现在必须考虑到 患者/提供者互动的安全性。这一安全要求是一个迫切的未满足的需要， 临床医学一个示例是使用常规的方法捕获心血管生命体征数据的过程。 交互式监测（CIM）工具的手表，单点脉搏血氧仪，血压计在 在诊所访问的开始。这种数据采集的遭遇现在使患者和提供者处于危险之中。 RFPi开创性的多光谱生理可视化（MSPV）是一种完全非接触、非接触、 侵入性和非电离医学成像技术，提供：1）血流分布（流入 血管和组织灌注）; 2）2D外周血氧饱和度（2D SpO 2）， 相同FOV中的组织;以及3）心率，血压， 速率-压力乘积、灌注变化以及来自BFD成像的元数据的其他。该分析 显示器在10-14秒的相干近红外激光和可见光下立即实时呈现 显像MSPV的第一个临床形状因子，称为iPhanty ™，已被FDA批准用于开放手术。 先前的研究表明，MSPV数据符合或超过当前的临床实践数据标准， 一致性、可变性和准确性。MSPV技术的临床适用形状因子将 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- 制作和护理交付。 本阶段I提案旨在将MSPV患者光学-组织界面重新设计为1.5-2.5 cm 工作距离（摄像机透镜到组织表面的距离）。这提出了一些光学工程和 设计挑战，因此RFPI汇集了两个杰出的合作组织：INOV INC， 30-年光学设计和工程公司（超过5亿美元的收入来自客户从INOV的产品 设计）和Nocturnal Product Development，LLC，一家位于北卡罗来纳州达勒姆的领先医疗器械设计公司。 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， 反射率图像捕获的挑战，导致这个短WD;和2）原型建立一个医疗级 生理学测定（MGPD）器械，在50名成人志愿受试者中进行临床概念验证测试 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。 这些第一阶段数据和协作组织团队将快速进入第二阶段应用程序 旨在构建和测试临床MGPD外形规格以供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，在> 2018年记录的美国40，000个指定门诊诊所站点。