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.
Keywords: Biomedical devices; biomechanical testing/analysis; biomedical instrumentation; cardiovascular implants; cardiovascular system mechanics.