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

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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.