Development of a Highly Accurate Wrist/Ankle-Mount Non-invasive Blood Pressure Monitor for Neonatal Patients

SUMMARY/ABSTRACT More than 340,000 neonates are admitted to the neonatal intensive care unit (NICU) each year in the United States. Monitoring arterial blood pressure (BP) for them, particularly preterm low-birthweight newborns, can be challenging. The oscillometric (OSC) brachial cuff is much less accurate in neonates than in adults because it derives systolic and diastolic pressures using population-based ratios. With lower BP, neonates as a group are statistically underrepresented in these ratios, thus their BP measurements tend to be erroneous. The standard method for neonatal BP monitoring is via the umbilical arterial catheter (UAC). However, UAC fails to work for approximately 10% of patients when both umbilical arteries are damaged or regressed after birth. For these patients, there is no alternative available. UAC also carries significant risks, including thrombosis, hematomas, infections, and even death. To address this unmet clinical need for neonatal BP monitoring, JB HealthTech, Inc. (JBH) is developing a highly accurate non-invasive BP monitor neoBPTM that operates in 3 modes. Its continuous mode provides high-fidelity arterial BP waveforms similar to UAC, to derive arterial pressures, respiration rate, and a suite of hemodynamic parameters. Its intermittent mode gives a convenient BP snapshot and heart rate, similar to OSC. Its periodic mode runs at predefined running/resting time intervals for any clinical needs in between. neoBP is based on a volume clamp (VC) technology, which is advantageous over other technologies, such as statistical modeling where neonates are underrepresented, less accurate devices with airbags only, and cuffless devices depending on calibration with UAC or OSC for every use. Using a novel closed-form theoretical framework without empirical elements, we dynamically build the patient-specific pressure-volume function and solved a long-standing inaccuracy problem of the BP industry. We have implemented the innovative algorithms on the prototype, initiated preliminary adult clinical testing, and filed four US patent applications. JBH has strong engineering expertise in medical device development. We also have partnered with neonatologists and cardiologists to benefit from their clinical experiences and insights. With this diverse, complementary team, we will advance our device from prototype to practice. Our tasks for this Phase I SBIR project include hardware redesigns and rigorous clinical tests. We will build our second-generation hardware and neonatal cuffs, which meet product specification matrixes. We will also validate the accuracy of neoBP against the standard of care UAC to demonstrate its feasibility. A successful comparative study in the NICU will be the milestone for the project to advance to Phase II. neoBP would be the first highly accurate non- invasive BP monitor in the NICU and provide a simple and reliable way to measure BP for all neonates. With accuracy comparable to UAC, neoBP will eliminate UAC-related complications and become an indispensable tool in every neonatologist's armamentarium. In Phase II, we will further test it in multi-center clinical studies, resolve any clinical related issues, redesign it for manufacturability, and receive FDA 510(k) clearance.