Safety and Automation Concepts for Artificial Implantable Lungs - SmartLungControl

发展SPP 2014“迈向可移植肺”所述的体外长期肺支持，需要大量的技术创新。人们关注的一个焦点是长期人工肺的创新组件的开发，例如膜设计、表面生物化或抗凝。在2014年SPP框架内，申请者已经解决了将患者连接到这种人工肺的问题。另一个项目涉及使用硬件在环试验台对这种长期设置进行评估的新的体外测试方法。除了硬件的改进，长期肺支持的操作，甚至植入式人工肺的操作将与目前的治疗方法有很大的不同。虽然今天的体外肺支持是在重症监护病房中由临床专家直接监督进行的，但长期程序也将在重症监护病房之外使用，作为最终目标，即使是在门诊环境中也是如此。由于缺乏受过适当培训的医务人员(如重症监护护士、输液师或重症监护医生)对该系统的持续护理和监督，需要从根本上重新考虑控制和安全概念。因此，这项提议将应对自主操作的新挑战。新的方法、算法和传感器将被概念化和研究。以前的自动化方法(我们在亚琛的团队过去在这方面做出了重大贡献)侧重于支持临床专家维护操作点和安全监控。在拟议的项目中，我们想要研究一种概念，用于在重症监护病房外对长期人工肺进行需求适应控制器和安全监测。在第一步中，将根据现有的患者和动物试验数据进行需求分析，然后使用德尔菲法进行系统的专家调查。其次，将对自主人工肺的控制器设计以及安全概念进行研究和评估。为此，将开发基于需求的适应和可靠性概念所需的新传感器概念。最后，原型将在硅胶、体外和体内动物实验中进行验证和测试。在这里，我们将讨论各种基本条件，动员引起的变化，以及定义的关键操作状态。作为我们研究的结果，我们将提出一个概念，用于在重症监护病房外进行长期人工肺的安全、需求适应和个性化操作。

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.