A research team of clinical medicine, optical physics, mechanical and electrical engineering disciplines at ECU has invented a new biomedical imaging technology, Multi-Spectral Physiologic Visualization (MSPV). MSPV is a proprietary laser-illuminated hardware/ software imaging system that is non-contact (35 cm imaging distance), non-invasive (no dyes or injections), non-ionizing (no X-ray, CT), and poses no risk to patients. MSPV is a platform technology (multiple clinical applications) to visualize (image + analysis) and quantify blood flow in vessels and perfusion in tissues in real-time during surgical procedures and clinic evaluations. The ECU team and its commercialization partner RFPi, LLC have also documented derivation of Physiologic Status Parameters (PSPs) from the metadata of this physiologic-based MSPV imaging. This Phase I proposal will study two aspects of MSPV directly related to Point-Of-Care (POC) applications: Imaging Optimization, and Monitoring Accuracy. In POC settings, medical standards of quality and accuracy must be met to reduce complications and prevent avoidable deaths. The Hypothesis of this STTR Phase I Research Strategy is that the MSPV specifications can be optimized for tissue-specific blood flow/perfusion analyses, and the medical accuracy of PSPs can be validated at the optimized specifications. For Imaging Optimization (Specific Aim #1), data are needed to better understand light energy-tissue interactions across the tissues that can be imaged in surgeries at POC (heart, GI organs, skin, veins, arteries, muscle, healing tissues), to then optimize MPSV to tissue-specific configurations. For Monitoring Accuracy (SA #2), preliminary validation of PSPs for medical quality and accuracy is needed to design a portable, hand-held POC device for MSPV visualizations, PSP determinations and trend analyses. Optical physics research techniques with phantoms will be used SA #1 to examine depth of penetration, refraction, reflection, energy transfer, and power density at different illumination wavelength configurations. In SA #2, normal volunteers will undergo MSPV imaging of the palmar surface of the hand at optimal skin MSPV configurations; derived PSP data will be correlated with data from current POC monitoring devices. The findings from both Aims will be important new data. SA #1 results should provide the technical specification pathway for RFPi to develop tissue-specific applications for MSPV flow and perfusion visualization and quantification. SA #2 results should catalyze development of RFPi's vision for a transforming POC monitoring technology solution. Both results bring new physiologic data to POC, to: 1) drive better decision-making based on real-time and trended data; 2) improve clinical care quality; and 3) reduce healthcare costs.
Medical technologies that give immediate new data to providers at point-of-care are evolving. A new imaging technology that provides real-time blood flow and tissue perfusion data has been developed. This project will study two clinical application aspects of this technology: Imaging Optimization, and Monitoring Accuracy.
