Using the applied classification as a tool for future design will not only provide insight into previously applied steering technology, it will identify new and unexplored options too. Additionally, insight into the requirements and challenges for catheter steering toward and inside the heart, will allow more dedicated systems, allowing intervention- and patient-specific instrument manipulation.

In recent years, steerable catheters have been developed to combat the effects of the dynamic cardiac environment. Mechanically actuated steerable catheters appear the most in the clinical setting; however, they are bound to a number of mechanical limitations. The aim of this research is to gain insight in these limitations and use this information to develop a new prototype of a catheter with increased steerability. The main limitations in mechanically steerable catheters are identified and analysed, after which requirements and solutions are defined to design a multi-steerable catheter. Finally, a prototype is built and a proof-of-concept test is carried out to analyse the steering functions. The mechanical analysis results in the identification of five limitations: (1) low torsion, (2) shaft shortening, (3) high unpredictable friction, (4) coupled tip-shaft movements, and (5) complex cardiac environment. Solutions are found to each of the limitations and result in the design of a novel multi-steerable catheter with four degrees of freedom. A prototype is developed which allows the dual-segmented tip to be steered over multiple planes and in multiple directions, allowing a range of complex motions including S-shaped curves and circular movements. A detailed analysis of limitations underlying mechanically steerable catheters has led to a new design for a multi-steerable catheter for complex cardiac interventions. The four integrated degrees of freedom provide a high variability of tip directions, and repetition of the bending angle is relatively simple and reliable. The ability to steer inside the heart with a variety of complex shaped curves may potentially change conventional approaches in interventional cardiology towards more patient-specific and lower complexity procedures. Future directions are headed towards further design optimizations and the experimental validation of the prototype.

Even though technological advances have increased the application area of minimally invasive surgery (MIS), there are still hurdles to allow for widespread adoption for more complex procedures. The development of steerable instruments, in which the surgeon can alter the tip orientation, has increased the application area of MIS, but they are bulky, which limits their ability to navigate through narrow environments, and complex, which complicates miniaturization. Furthermore, they do not allow for navigating through complex anatomies. In an effort to improve the dexterity of the MIS instruments, while minimizing the outer dimensions, the previously developed cable-ring mechanism was redesigned, resulting in the thinnest, Ø 2 mm (Ø 1 mm lumen), eight degrees-of-freedom (DOF) multisteerable tip for MIS to date. The multisteerable tip consists of four steerable segments of 2DOF stackable elements allowing for ±90 deg articulation, as well the construction of complex shapes, actuated by 16 Ø 0.2 mm stainless steel cables. In a proof-of-principle experiment, an ultrasound transducer and optical shape sensing (OSS) fiber were inserted in the lumen, and the multisteerable tip was used to perform scanning motions in order to reconstruct a wire frame in three-dimensional (3D). This configuration could in future be used to safely navigate through delicate environments and allow for tissue characterization. Therefore, the multisteerable tip has the potential to increase the application area of MIS in future, as it allows for improved dexterity, the ability to guide several tip tools toward the operation area, and the ability to navigate through tight anatomies.

This work focuses on the design of a new device (called ChoRe) to place artificial chords in the mitral valve structure during a trans-catheter procedure. The aim of the device is to restore the correct functionality of the valve and solve mitral valve regurgitation, that is, a common consequence of chordae tendineae rupture. An analysis of the requirements was carried out and used to design and develop a first functional prototype. The resulting device was able to connect artificial chords at the posterior leaflet of the mitral valve and at the apex of the left ventricle, also allowing the control of the artificial chord length. The ChoRe was tested ex-vivo in bovine hearts. The qualitative assessment of the ChoRe focused on the performance of the device and preliminary evaluation of the procedure time. Results demonstrated that the device is able to create a top and bottom fixation in an average time of 3.45 ± 1.44 min. Future improvements will focus on enhancing the connection at the leaflet, as well as the overall functionality, in order to guarantee better control of the artificial chord length. This work shows future potentials for more patient-specific treatments in trans-catheter scenarios for mitral valve repair.

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.