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

患有晚期肺病的病人非常脆弱。人工肺（AL）的中央插管是当今临床成功的阿喀琉斯之踵，因此手术方法应对患者造成最小的创伤。植入后，不受限制的活动性对AL患者至关重要。仍需研究哪种灌注途径在可实现的流速方面同时足够有效，可用于微创放置（和移除）并允许最大的活动性。虽然靠近心脏的中央通道似乎是有利的，但目前还没有专门的医疗工具和设备。当前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，以进行微创手术或介入AL置入。这是实现在一个三步迭代的方法。在每次迭代中，检查AL模拟回路与所有可想象的血管或血管连接部位的连接。随后进行手术和技术评价以及血流动力学表征，以收集所有相关参数并在不同入路之间进行比较。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。第二套（二：辅助MI手术）将补充新开发的技术，从外部辅助微创手术方法。这主要包括新的内窥镜器械，允许缝合、支架或以其他方式将回路连接到血管。在第三个工作包中，该方法被颠倒：在主要血管内部分（III：血管内手术）中，仅需要内窥镜手术来辅助相当介入的基于导管的方法。在每个包中，通过体外和模拟设置，尸体试验和试点动物试验阶段迭代开发。然后，通过对所有微创插管技术进行全面表征，最终确定该项目，这些技术用于连接AL（有或没有额外的血泵）。然后，这些数据将被提供，并与重点项目（SPP 2014）的其他项目相关联。

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).