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 医疗保健提供的各个方面都受到了共同大流行的破坏。在这个新兴时代 病原体和抗药性，即使是平凡的和护理标准的做法，现在也必须说明 患者 /提供者互动的安全性。此安全要求是立即未满足的需求 临床医学。一个例子是使用常规的捕获心血管生命体征数据的过程 手表的互动监测（CIM）工具，单点脉冲氧和血压计处 诊所访问的开始。现在，这种数据捕获的遇到使患者和提供者处于危险之中。 RFPI的开创性多光谱生理可视化（MSPV）是一种完全无接触的 提供的侵入性和非电源医学成像技术：1）血流分布（流在 在组织中的血管和灌注）（FOV）； 2）2D外周氧饱和（2D SPO2） 在同一FOV中的组织； 3）心率，血压的心血管生理状态参数， BFD成像元数据的速率压力产物，灌注变化以及其他。这个分析 展示是在10-14秒的连贯NIR激光器和可见光的立即实时显示的 成像。 MSPV的第一个临床形式称为iCnectionty™，是FDA批准的，用于开放手术使用。 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技术的适合诊所的形式将 消除这种遭遇风险，同时捕获质量更好的心血管生命体征数据以更好地决策 - 进行和护理交付。 该阶段的建议目标是将MSPV患者光学系接口重新设计为1.5-2.5 cm 工作距离（相机镜头到组织表面距离）。这提供了许多光学工程和 设计挑战，因此RFPI汇集了两个出色的合作组织：Inov Inc，一个 30年的光学设计和工程公司（客户从INOV产品中获得的收入超过$ 500 m 设计）和夜间产品开发有限责任公司，该公司是北卡罗来纳州达勒姆市领先的医疗设备设计公司。 该提案的两个具体目的是：1）开发光学解决方案以优化照明和 反射率图像捕获挑战是由这个简短的WD造成的； 2）原型建造医学等级 生理确定（MGPD）设备，并在50名成人志愿者中进行临床概念验证测试 在MSPV-奖的研究中，确定一致性，可变性和准确性与目前正在使用的CIM工具。 这些I阶段数据和这个合作组织团队将迅速转移到II期应用程序 旨在构建和测试FDA提交的临床MGPD形式。这项高度创新的技术 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，美国指定的40,000名指定的门诊诊所现场记录了。