Safety and Automation Concepts for Artificial Implantable Lungs - SmartLungControl

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The development of extracorporeal long-term lung support, as addressed in SPP 2014 "Towards an Implantable Lung", requires a multitude of technical innovations. One focus of attention was on the development of innovative components of a long-term artificial lung, such as membrane design, biologization of surfaces, or anticoagulation. Within the framework of the SPP 2014, the applicants already addressed the question of connecting the patient to such an artificial lung. A further project was concerned with new in-vitro test methods for the evaluation of such long-term setups using hardware-in-the-loop test benches. In addition to improved hardware, the operation of long-term lung support or even an implantable artificial lung will differ significantly from present therapies. While today's extracorporeal lung support is performed in an intensive care unit under the direct supervision of a clinical expert, a long-term procedure will also be used outside the intensive care unit, and, as a final goal even in an ambulatory setting. The lack of continuous care and supervision of the system by appropriately trained medical personnel, such as intensive care nurses, perfusionists, or intensive care physicians, requires a fundamental reconsideration of the control and safety concept.As a consequence, this proposal will address the new challenges of autonomous operation. New methods, algorithms, and sensors will be conceptualized and studied. Previous approaches for automation (where our group in Aachen made a significant contribution in the past) focused on supporting the clinical expert regarding maintaining the operation point and safety monitoring. In the proposed project, we want to investigate a concept for a demand-adapted controller and safety monitoring of a long-term artificial lung outside the intensive care unit. In the first step, a requirements analysis based on existing patient and animal trial data will be carried out, followed by a systematic expert survey using the Delphi method. Secondly, a controller design, as well as a safety concept for the autonomous artificial lung, will be researched and evaluated. To this end, new sensor concepts, required for the demand-based adaptation and dependability concept, will be developed. Finally, the prototype will be validated and tested in-silico, in-vitro, and in-vivo in animal experiments. Here we will address various basic conditions, changes induced by mobilization, as well as defined critical operating states.As a result of our research, a concept will be available for the safe, demand-adapted, and individualized operation of a long-term artificial lung outside of the intensive care unit.