Abstract
PurposeIn 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.MethodsTwo 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 & ConclusionsThe 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.
Highlights
Catheters and sheaths are used to treat and diagnose disorders in the majority of cardiac interventions
Besides the regular push/pull and torque movements, steerable catheters may have additional Degrees of Freedom (DOF) and one or more deflectable segments in the tip that allow the interventionist to navigate through the cardiac environment and precisely position the tip
We aimed to investigate the performance of the prototypes in the cardiac environment and under limited instrument visibility
Summary
Catheters and sheaths are used to treat and diagnose disorders in the majority of cardiac interventions. Precise manipulation of cardiac catheters remains a complicated task, due to the dynamic cardiac environment and the limited freedom of catheter movement.. A number of different steerable catheter systems have become available commercially in recent years. Besides the regular push/pull and torque movements, steerable catheters may have additional Degrees of Freedom (DOF) and one or more deflectable segments in the tip that allow the interventionist to navigate through the cardiac environment and precisely position the tip. Commercially available steerable systems include the manually steerable introducer sheath AgilisTM NxT (St. Jude Medical, St. Paul, MN, USA), the robotic catheter systems SenseiÒ X and MagellanTM (Hansen Medical, Mountain View, CA, USA), and the remote magnetic catheter navigation system Niobe (Stereotaxis, St. Louis, MO, USA). Clinical trials have shown significant improvements in procedural time and patient
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