Objectives: To develop a functional prototype of a device capable of reliably applying drug-coated titanium seeds transurethrally into the bladder wall through a cystoscope, as part of a seed-based system for intravesical drug instillation to treat non-muscle invasive bladder cancer (NMIBC). This innovation addresses the limitations of current approaches, such as short drug dwell time in the bladder lumen and poor drug penetration into the bladder wall, while preserving the benefits. Methods: An interdisciplinary collaboration between biomedical engineers and clinical urologists followed a rigorous design process with theoretical evaluation of various designs, resulting in the production of a prototype. This was tested for its ability to implant seeds into different materials (gelatin, bovine muscle tissue). Model-based application by a panel of urologists resulted in the refinement of the initial prototype. The optimized prototype was finally tested in an ex vivo pig bladder model. Results: A functional prototype combining a reusable user interface component and a single-use component was successfully produced. In this cystoscopy-based approach, the seeds stored at the distal end of the device are applied to the bladder wall using a proximal trigger/plunger mechanism. We demonstrated efficient and accurate seed implantation in bladder-mimicking models and in an ex vivo porcine bladder experiment. Conclusions: We developed a device that provides proof-of-concept for the feasibility of transurethral intravesical seed application using the working channel of a flexible cystoscope. With further refinement of the design and adequate validation of corresponding drug-coated seeds, this device would be suitable for testing in patient bladders. Level of evidence: Not applicable
Maas et al. (Wed,) studied this question.