BioMechanical Engineering, Delft University of Technology, Delft, Zuid-Holland, The Netherlands.
Erasmus Medical Center, Electrophysiology, Rotterdam, Zuid-Holland, The Netherlands.
Cardiovasc Eng Technol. 2020 Dec;11(6):769-782. doi: 10.1007/s13239-020-00499-3. Epub 2020 Nov 18.
In previous studies we developed two mechanical prototypes of steerable catheters: the Sigma, which uses joysticks to actuate two steerable tip segments, and the Epsilon, which has a handle that is an enlarged version of the tip. In this study, we present a first performance evaluation of the prototypes in the cardiac environment. The evaluation was carried out by an expert user, an electrophysiologist with over 20 years of experience, to obtain insight in clinically relevant factors.
Two experiments were conducted. In the first experiment, the Sigma was used in a passive beating heart setup connected to pumps with a saline solution and camera visualization, and compared with the expert's past experience with conventional steerable catheters. In the second experiment, the Sigma was used in an active beating heart setup with blood perfusion through the coronary arteries and echo visualization, and compared with the Epsilon prototype. The prototype was evaluated through questionnaires on task performance, catheter usability, and workload. After each of the experiments, the catheter characteristics were evaluated via a survey and followed by an in-depth interview.
RESULTS & CONCLUSIONS: The expert user found the passive beating heart setup to more successful than the active beating heart setup for the purpose of this experiment, with insightful visualization while the heart was in beating condition. The steerability of the prototypes was experienced as useful and clinically relevant. Based on the questionnaires and interview we were able to identify future design improvements and developments for the steerable catheter prototypes.
在之前的研究中，我们开发了两种可转向导管的机械原型：Sigma，它使用操纵杆来驱动两个可转向的尖端段；以及 Epsilon，它的手柄是尖端的放大版本。在这项研究中，我们首次在心脏环境中对原型进行了性能评估。该评估由一位经验丰富的专家用户（一位拥有 20 多年经验的电生理学家）进行，以了解与临床相关的因素。
进行了两项实验。在第一项实验中，Sigma 在连接有盐水泵和摄像头的被动跳动心脏装置中使用，并与专家过去使用传统可转向导管的经验进行了比较。在第二项实验中，Sigma 在具有冠状动脉血液灌注和超声可视化的主动跳动心脏装置中使用，并与 Epsilon 原型进行了比较。通过任务绩效、导管可用性和工作负荷的问卷对原型进行了评估。在每项实验之后，通过调查和深入访谈对导管特性进行了评估。
专家用户发现，对于本实验的目的而言，被动跳动心脏装置比主动跳动心脏装置更成功，因为在心脏跳动的情况下可以进行有洞察力的可视化。原型的可转向性被认为是有用的，并且与临床相关。根据问卷调查和访谈，我们能够确定可转向导管原型的未来设计改进和发展方向。
