Purpose

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.

Methods

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.

中文翻译：

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对孤立跳动心脏中新型可操纵导管的首次专家评估

目的

在之前的研究中，我们开发了两种可操纵导管的机械原型：Sigma和Epsilon，它使用操纵杆来驱动两个可操纵的尖端部分，而Epsilon的手柄是尖端的放大版本。在这项研究中，我们对心脏环境中的原型进行了首次性能评估。评估由专家用户（一位拥有 20 多年经验的电生理学家）进行，以深入了解临床相关因素。

方法

进行了两个实验。在第一个实验中，Sigma被用于被动跳动的心脏装置，该装置连接到带有生理盐水和摄像头的泵，并与专家过去使用传统可操纵导管的经验进行了比较。在第二个实验中，Sigma用于通过冠状动脉进行血液灌注和回波可视化的主动跳动心脏设置，并与Epsilon原型进行比较。该原型通过有关任务性能、导管可用性和工作量的问卷进行评估。每次实验后，通过调查评估导管特性，然后进行深入访谈。

结果与结论

出于本实验的目的，专家用户发现被动跳动心脏设置比主动跳动心脏设置更成功，在心脏处于跳动状态时具有洞察力的可视化。原型的可操纵性被认为是有用的和临床相关的。根据问卷和访谈，我们能够确定可操纵导管原型的未来设计改进和开发。