Technologies to safely, effectively, and efficiently monitor clinical cardiovascular status in patients with one or more cardiovascular-related diseases are an unmet need in healthcare. Since small changes in clinical status can compound rapidly, monitoring a number of physiologic status parameters (PSPs) simultaneously and trending their changes over time is crucial for early intervention, in order to maintain cardiovascular status stability in the outpatient setting. Elderly patients in whom healthy independent living is a desired personal, family and healthcare goal are especially in need of technology solutions that will provide reliable clinical data in an efficient format to the physician, while also providing feedback on well-being status that is understandable to these patients and their families. Important emotional reassurance is conveyed as well. RFPi, Inc. envisions a simple, efficient, patient-friendly, and effective non-invasive cardiovascular monitoring and communication technology to promote healthy independent living. This technology vision is an exciting continuation of RFPi?s ongoing agenda for onsite tools and technologies for point-of-care (POC) monitoring, and is based on RFPi?s novel imaging technology, termed Multi-spectral Physiologic Visualization (MSPV). MSPV images and quantifies relative blood flow distribution (blood flow in vessels and perfusion in tissues) non-invasively and in real-time. The distribution and the physiologic status drivers of that distribution (e.g., heart rate, blood pressure) are both contained in the digital imaging data. These simultaneously- obtained PSPs are linked with real-time perfusion assessment, and provide a comprehensive digital profile trended over time to document changes in the patient?s cardiovascular status. To increase effectiveness, the PSP portfolio must also include non-invasive determination of peripheral oxygen saturation (SpO2) and hemoglobin concentration [Hgb], where an elegant solution would be to derive SpO2 and [Hgb] by augmenting the MPSV technology solution itself. This would directly link oxygen carrying capacity with perfusion and oxygen delivery. Our preliminary studies confirm that this is indeed achievable. Validation of this approach and development of the plan to build a pre-clinical prototype will be the products of this Phase I SBIR.
In Specific Aim #1, comparison between published data and the optimized MPSV+SpO2 solution for remote SpO2 monitoring will be made. The optimized configuration SpO2 data will be then correlated with pulse oximetry and arterial blood gas data experimentally.
In Specific Aim #2, the engineering and product design for the commercial prototype of this novel MPSV+SpO2 solution will be developed in collaboration with Nocturnal Product Development, Durham, NC. A simple, intuitive, iPad-sized form factor to non-invasively image real-time dynamic perfusion to the palm of the hand and generate enhanced PSP trends in < 10 sec is achievable. In short, an entirely novel cardiovascular monitoring and assessment approach for healthy independent living in elderly patients.
RFPi, Inc. is providing an entirely novel approach to cardiovascular monitoring, to meet the specific need for technologies to enable healthy independent living in elderly patients. This technology vision is an exciting continuation of RFPi?s ongoing agenda for onsite tools and technologies for point-of-care monitoring. The product of this Phase I SBIR will be the validation of this independent living technology solution and the engineering and product development plan for the pre-commercial prototype.
