Fluid channel Array Brick (FAB) Blood-Gas Exchangers for building Artificial Lungs for Critical Respiratory Failure Treatment

Project Summary/Abstract Essential life-maintaining O2 and CO2 gas exchange for over 1 million patients worldwide with critical respiratory failure or undergoing heart/lung surgery is provided by flowing blood through an extracorporeal circuit containing an oxygenator. Commercially available oxygenators use proprietary spaced assemblies of Hollow Fibers (HFs) as blood-gas exchangers. Blood flows turbulently around the outside of these HFs while a sweep gas flows through their hollow channels. Through the microporous HF walls, O2 diffuses into the blood, and CO2 diffuses out, converting venous blood into arterial blood. Key hemostatic complication risk factors of oxygenators, like blood-contact area, priming volume, turbulent and high-pressure flow conditions, accumulated shear stress, and gas transfer rate decay pose continuous health risks that affect costs, treatment, and recovery, and further aggravated by prolonged use, contribute significantly to morbidity and mortality. HF oxygenator technology has only incrementally improved over the last decade and alternative technologies that could significantly improve performance and/or safety are still in their low flow capacity stage. The goal of this SBIR proposal is to develop optimized novel Fluid channel Array Brick (FAB) blood-gas exchangers, for maximizing safety gains and use time for an optimized family of safer FAB-Oxygenators. FABs have a patterned array of straight fluid channels with laminar blood flow paths, higher porosity for gas exchange, and a higher surface-area-to-volume ratio compared to an equivalent HF assembly. Optimized higher efficiency FABs will lead to significant extracorporeal oxygenator safety gains. This will decrease blood damage and coagulation risk, unlock longer usage potential, reduce blood product transfusions, and replacement frequency during long-term use, which further reduces healthcare costs and infection risks. The long-term goal of the SBIR proposal is to enable the development of a family of safer FAB-Oxygenators, with each device tailored to the needs of a specific patient class. FAB-Oxygenator scale-up to adult patient class, together with fully optimized FABs, under a future development, could lead to an extracorporeal artificial lung. In Phase I, we will design/manufacture a series of FABs with different fluid channel array patterns and test them inside FAB-Oxygenators for up to 6 hours. These results will be used to develop a performance prediction for an optimized, full adult FAB-Oxygenators incorporating respective optimized FABs. Feasibility will be established by in vitro evaluation under the FDA-recommended AAMI 7199 test protocol of optimized FABs, modeling, and adult FAB-Oxygenator design performance prediction comparison to commercially HF oxygenators. Phase II funding will allow to develop and test further improved and/or antithrombotic coated FABs for up to 7 days of use, and to conduct first in vivo testing to refine safety gain advantages. We plan to establish licensing and FAB-supply partnerships with oxygenator manufacturers and to assemble a team of experts, clinicians, marketers, manufacturers, and engineers who can jointly bring FAB-Oxygenators to market.