The OncoReach Stylet for Brachytherapy: Design Evaluation and Pilot Study

摘要

Cervical cancer accounts for a significant portion of the global cancer burden among women. Interstitial brachytherapy (ISBT) is a standard procedure for treating cervical cancer; it involves placing a radioactive source through a straight hollow needle within or in close proximity to the tumor and surrounding tissue. However, the use of straight needles limits surgical planning to a linear needle path. We present the OncoReach stylet, a handheld, tendon-driven steerable stylet designed for compatibility with standard ISBT 15- and 13-gauge needles. Building upon our prior work, we evaluated design parameters like needle gauge, spherical joint count and spherical joint placement, including an asymmetric disk design to identify a configuration that maximizes bending compliance while retaining axial stiffness. Free space experiments quantified tip deflection across configurations, and a two-tube Cosserat rod model accurately predicted the centerline shape of the needle for most trials. The best performing configuration was integrated into a reusable handheld prototype that enables manual actuation. A patient-derived, multi-composite phantom model of the uterus and pelvis was developed to conduct a pilot study of the OncoReach steerable stylet with one expert user. Results showed the ability to steer from less-invasive, medial entry points to reach the lateral-most targets, underscoring the significance of steerable stylets.