Design and development of a full-scale oxygenator model for future biohybrid lung application

Use of conventional oxygenators is typically limited to 10–14 days due to poor hemocompatibility. Endothelialization of gas exchange membranes can create a natural non-thrombogenic surface and has proven effective in small laboratory models, but this approach requires a specific oxygenator design that can support both effective gas exchange and future membrane endothelialization. Thus, we developed a modular spiral-coil oxygenator using a fabrication approach that enables the production of a large membrane surface area with integrated blood channels. We designed and fabricated multiple oxygenator prototypes using a rolled flat-sheet PDMS/spacer/PDMS membrane structure and evaluated their gas exchange and fluid flow. Prototypes were tested for gas exchange performance following ISO 7199:2016 standards. Computational fluid dynamics (CFD) simulations were performed to assess flow distribution and wall shear stress (WSS). Among the tested prototypes, two designs provided the most promising results. They achieved surface areas of 0.20 m² and 0.34 m² with priming volumes of 348 mL and 312 mL, respectively. Both models showed quantifiable gas exchange supporting the feasibility of the proposed concept. CFD simulations revealed no stagnant areas and low WSS. These results demonstrate the feasibility of a modular spiral-coil oxygenator with a large-area flat-sheet membrane and millimeter-scale blood channels. While gas transfer requires improvement before clinical applicability for extracorporeal CO 2 removal, the fabrication approach provides a foundation for future endothelialization and development of long-term biohybrid lung support devices.