The ProSTATIC – a Suction based Stabilisation Instrument for the Prostate

Abstract

Treatment of prostate cancer can be done by performing brachytherapy, where radioactive seeds are transperineally implanted in the prostate via needles. A known problem during treatments with needles is the risk of targeting errors caused by the deviation of the needle from the planned path in the prostate. One of the main sources of this error is the displacement of the prostate due to insertion of the needle. Often, stabilisation needles are used to stabilise the prostate, however, stabilisation needles alter prostate properties, damage tissue, and do not fully reduce prostate displacement. Therefore, in this study, we propose and evaluate an alternative solution that stabilises the prostate without additional tissue damage. The stabilisation solution is a modular suction cup referred as the ProSTATIC, which can be transperineally inserted via a 5 mm incision to attach to the prostate within the rectoprostatic space. The ProSTATIC has a multi-holed design consisting of three structural layers with their functionality; (1) the top to maintain the pressure inside of the suction cup and provide for structural stability, (2) the footprint to adapt and form a closed seal with the prostate surface, and (3) the self-regulating valves to increase the attachment reliability on irregular surface textures. For the footprint, we experimented with micro-patterns and suction hole sizes to increase the overall grip force. The prototype was completely fabricated out of biocompatible and ultrasound-compatible silicone rubber using mould casting. An experimental evaluation showed that the self-regulating valves work only on healthy prostate phantom. On healthy-tumorous and full tumorous tissue phantoms the suction holes deform, hindering the optimal working of the valves and leading to air leaks. Furthermore, only the prototype with the base footprint with enlarged suction holes (from 2 mm to 3.2 mm diameter) and radial ridges was able to generate a maximum grip force higher than the required 5 N for stabilisation and demonstrated that prostate displacement was reduced by 75% during needle insertion without the use of the ProSTATIC. The prototype proposed in this study forms an initial breakthrough in safe and reliable volumetric stabilisation of the prostate during brachytherapy.