Evaluation and development of minimally invasive techniques to connect an artificial lung to the heart and central vessels (Connex AL)

患有终末期肺部疾病的患者是极其脆弱的。人工肺(AL)的中心插管是当今临床取得成功的致命弱点，因此手术方法应该对患者造成最小的创伤。植入后，对AL患者来说，自由活动是至关重要的。在可达到的流速、最小侵入性的放置(和取出)和最大的移动性方面，哪种途径的灌流是足够有效的，还有待研究。尽管靠近心脏的中心通道似乎是有利的，但目前还没有专门的医疗工具和设备。本项目的目的是对所有解剖学上可能的插管部位进行系统分类，以便进行微创外科或介入性AL置入。这是通过三步迭代方法实现的。在每次迭代中，检查AL模拟电路到所有可想象的心脏或血管连接部位的连接。接下来是手术和技术评估，以及血流动力学特征，以收集所有相关参数，并在不同的入路之间进行比较。第一个工作包将从目前可用的微创和内窥镜技术(I：MI手术)开始。第二组(II：辅助心肌梗死手术)将补充新开发的从外部辅助微创手术入路的技术。这主要包括新的内窥镜设备，允许将电路装订、支架或以其他方式连接到血管。这种方法在第三个工作包中是相反的：在主要的血管内部分(III：血管内手术)，只需要内窥镜手术来辅助相当介入性的、基于导管的方法。在每个包中，开发都通过体外和模拟环境、身体试验和试点动物试验阶段迭代进行。然后，通过对所有用于连接AL的微创插管技术进行彻底的描述，最终完成该项目，无论是否有额外的血泵。然后提供这些数据，并将其链接到Focus方案(SPP2014)的其他项目。

Patients suffering from terminal pulmonary disease are extremely fragile. Central cannulation of an artificial lung (AL) is nowadays Achilles´ heel for clinical success and surgical approaches should therefore induce minimal trauma to the patient. Following implantation, unrestricted mobility is of paramount importance to the patient on AL. It remains to investigate, which route of perfusion is at the same time efficient enough in terms of achievable flow rates, available for minimal invasive placement (and removal) and allowing maximal mobility. Although a central access in proximity to the heart seems favourable, specialised medical tools and devices are currently unavailable. The aim of the current project is the systematic categorization of all anatomically possible cannulation sites for a minimal invasive surgical or interventional AL placement. This is realised in a three step iterative approach. In each iteration, the connection of an AL mock circuit to all imaginable cardial or vascular connection sites is examined. This is followed by a surgical and technical evaluation as well as a hemodynamic characterization to gather all relevant parameters and compare them between the different approaches. The first work package will start from the currently available minimalinvasive and endoscopic techniques (I: MI surgery). The second package (II: assisted MI surgery) will complement newly developed techniques that assist the minimal invasive surgical approach from the outside. This mainly includes new endoscopic devices allowing to staple, stent or otherwise connect the circuit to the vessel. This approach is inverted in the third work package: In the mainly endovascular section (III: endovascular surgery), endoscopic surgery is only needed to assist a rather interventional, catheter-based approach. Within each package, the development is iterated through an in vitro and simulation setting, a cadaver trial and a pilot animal trial phase. The project is then finalized by the thorough characterization of all minimal invasive cannulation techniques for the connection of an AL with or without an additional blood pump. This data is then made available and linked to other projects of the focus program (SPP2014).