Regulatory Science for Engineering Intuitive, Engaging, Safe and Effective Human-Device Interaction
(UH PI; Dr. Ramin Bighamian, Interoperability)
Background: Physiological closed-loop controlled (PCLC) medical devices are designed to autonomously regulate physiological variables by delivering interventions, such as fluids in hemorrhagic shock or oxygen for tissue oxygenation. However, PCLC devices are often not designed to account for the physiological interdependencies between different organ functions, such as the cardiovascular and respiratory systems. For instance, in patients with lung injury, adjusting mechanical ventilator settings to improve oxygenation can decrease cardiac output, leading a closed-loop fluid resuscitation system to increase the infusion rate to maintain blood pressure. This added fluid can worsen lung injury by increasing pulmonary fluid accumulation, which may then require further ventilator adjustments, creating a potentially destabilizing cycle. Without a thorough understanding of these interdependencies, PCLC devices may inadvertently trigger harmful feedback loops that compromise patient stability.
Research Plan: The primary goal of this project is to perform a comprehensive literature review on the interactions between the cardiovascular and respiratory systems under polytrauma conditions, with a focus on how these interactions affect PCLC medical devices. The analysis will also identify gaps in how well current models capture the essential interactive mechanisms between the heart and lungs, especially when two PCLC medical devices are used for fluid resuscitation and ventilation. Additionally, this project will explore how to integrate these insights into our in-house mathematical models in Matlab. Throughout the project, tasks such as annotating, aligning, reformatting, and verifying data from animal subjects may be required to verify the heart-lung interactions identified from literature. The findings will help develop strategies for optimizing multi-PCLC design and their performance evaluation and creating tools to prevent or identify destabilizing effects between them. Ultimately, this literature review and mathematical modeling project will support the development of PCLC medical devices that can adapt to the complex dynamics of polytrauma, enhancing patient safety in resource-limited settings.
Prerequisites: An introductory course in differential equations and familiarity with mathematical modeling and Matlab are desired.
Dr. Ramin Bighamian is a biomedical engineer with a research background in medical cyber-physical systems. His work focuses on developing regulatory science tools to evaluate the efficacy of autonomous medical devices, including physiological closed-loop controlled systems, brain-machine interface technologies, and machine learning applications in healthcare. He has authored and co-authored numerous peer-reviewed publications and presented at major conferences. Dr. Bighamian holds a Ph.D. in Mechanical Engineering from the University of Maryland, College Park, and is currently affiliated with the Division of Biomedical Physics in the Office of Science and Engineering Laboratories, Center for Devices and Radiological Health, U.S. Food and Drug Administration.