Currently, artificial-membrane lungs consist of thousands of hollow fiber membranes where blood flows around the fibers and gas flows inside the fibers, achieving diffusive gas exchange. At both ends of the fibers, the interspaces between the hollow fiber membranes and the plastic housing are filled with glue to separate the gas from the blood phase. During a uniaxial centrifugation process, the glue forms the “potting.” The shape of the cured potting is then determined by the centrifugation process, limiting design possibilities and leading to unfavorable stagnation zones associated with blood clotting. In this study, a new multiaxial centrifugation process was developed, expanding the possible shapes of the potting and allowing for completely new module designs with potentially superior blood flow guidance within the potting margins. Two-phase simulations of the process in conceptual artificial lungs were performed to explore the possibilities of a biaxial centrifugation process and determine suitable parameter sets. A corresponding biaxial centrifugation setup was built to prove feasibility and experimentally validate four conceptual designs, resulting in good agreement with the simulations. In summary, this study shows the feasibility of a multiaxial centrifugation process allowing greater variety in potting shapes, eliminating inefficient stagnation zones and more favorable blood flow conditions in artificial lungs.
Graphic abstract
The overall survival rate of extracorporeal life support (ECLS) remains at 60%. Research and development has been slow, in part due to the lack of sophisticated experimental models. This publication introduces a dedicated rodent oxygenator (“RatOx”) and presents preliminary in vitro classification tests. The RatOx has an adaptable fiber module size for various rodent models. Gas transfer performances over the fiber module for different blood flows and fiber module sizes were tested according to DIN EN ISO 7199. At the maximum possible amount of effective fiber surface area and a blood flow of 100 mL/min, the oxygenator performance was tested to a maximum of 6.27 mL O2/min and 8.2 mL CO2/min, respectively. The priming volume for the largest fiber module is 5.4 mL, while the smallest possible configuration with a single fiber mat layer has a priming volume of 1.1 mL. The novel RatOx ECLS system has been evaluated in vitro and has demonstrated a high degree of compliance with all pre-defined functional criteria for rodent-sized animal models. We intend for the RatOx to become a standard testing platform for scientific studies on ECLS therapy and technology.
The survival rate of extracorporeal life support (ECLS) remains overall at 60 %. Research and development is slow, partly due to the lack of sophisticated experimental models. This publication introduces a dedicated rodent oxygenator (“RatOx”) and shows preliminary in vitro classification tests. The RatOx has an adaptable fiber module size for various rodent models. Gas transfer performance over the fiber module for different blood flows and fiber module sizes were tested according to DIN EN ISO 7199.At the maximum possible amount of effective fiber surface and a blood flow of 100 ml/min, the oxygenator performance has been tested to a maximum of 6.27 ml O2/min and 8.2 ml CO2/min, respectively. The priming volume for this the largest fiber module is 5.4 ml, while the smallest possible configuration with a single fiber mat layer has 1.1 ml of priming volume. The novel RatOx ECLS system has been evaluated in-vitro to comply to a high degree with all predefined functionality criteria for rodent sized animal models. We intend for the RatOx to become a standard testing platform for scientific studies on ECLS therapy and technology.
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