Development of higher efficiency and safer Oxygenators for Critical Respiratory Failure Treatment and Heart/Lung Surgery Assist

Project Summary/Abstract Essential life-maintaining O2 and CO2 gas exchanges for over 700,000 patients worldwide with critical respiratory failure or undergoing heart/lung surgery are provided by flowing blood through an circuit containing an extracorporeal oxygenator. Commercially available oxygenators use hollow fibers (HF) as gas exchange components. 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. However, key hemostatic complication risk factors, like blood- contact area, priming volume, turbulent and high-pressure flow conditions, and accumulated shear stress, pose continuous health risks that affect treatment and recovery (i.e., temporary cognitive impairment, etc.) and contribute to significant morbidity and mortality (i.e., multiple organ failures, etc.), which are further aggravated with prolonged use. 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 infant (low flow capacity) stage. The goal of this SBIR proposal is to develop first a pediatric and then an adult safer FAB- Oxygenator. FAB-Oxygenators incorporate novel gas exchange components (Fluid channel Array Bricks, herein called “FABs”) having a straight and laminar blood flow path, low-pressure drop, and a higher O2 and CO2 gas transfer efficiency. These FAB-Oxygenators provide the required O2 and CO2 gas transfer rates with lower levels of multiple key hemostatic complication risk factors, i.e. (i) blood contact surface area, (ii) priming volume, (iii) pressure drop, and (iv) accumulated stress, thereby improving patient safety. These risk factors affect blood damage and loss, platelet activation, coagulation risk, demand for blood products, and gas transfer rate stability. The long-term goal of this SBIR proposal is to develop a family of safer oxygenators, optimally configured for each patient class (neonatal, pediatric, small, and large adults). 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 develop a safer pediatric FAB-Oxygenator. Feasibility will be established by comparison to commercially available pediatric HF oxygenators through in vitro evaluation under the FDA-recommended AAMI 7199 test protocol, and with modeling and a safety merit function value comparison. Phase II, if granted, will be sufficient to complete extended in vitro verification/validation of up to adult size FAB-Oxygenators, perform the first in vivo tests, begin the transfer to volume manufacturing, and prepare for FDA submission. We plan to establish FAB-Oxygenator design licensing/technology transfer and FABs/FAB-SubAssembly supply partnerships with multiple oxygenator manufacturers and to assemble a team of experts, clinicians, marketers, manufacturers, and engineers who can jointly bring FAB-Oxygenators into the market.