The RELIEF project proposes the following scientific and technological objectives:
O.1) Optimization of the artificial endo-urethral sphincters and their adaptation to para / tetraplegic users.
This optimization consists in the introduction of a magnetic safety mechanism that allows to urinate without the presence of the external forcing magnetic element, the customization of some components of the sphincters on the basis of the most common anatomies and the use by disabled patients, and the optimization of the ergonomics and usability for the external activation system based on permanent magnets.
O.2) Design of an extra-urethral artificial sphincter based on a bistable magnetic mechanism.
This objective consists in the development of a magnetic closing/opening system in order to develop a simple and minimally invasive device that allows to effectively control the hermetic closure and, when desired, the opening of the urethral canal. This allows the design of an innovative system, featured by a small number of mechanical components and reduced invasiveness respect to the extra-urethral systems currently available on the market.
O.3) Wireless monitoring of the closure of the artificial endo-urethral sphincter.
Objective 3 consists in the introduction of suitable sensors for the registration of the bladder pressure/filling level to provide the user with relevant information for the management of urination. This activity also foresees the investigation of the technical problems related to the emptying of the bladder for para- and tetra-plegic patients. This survey will be carried out at the clinical units by using the experience and feedback from health professionals.
O.4) In Vitro Set-up for the characterization of artificial valves and sphincters.
For the testing of the devices mentioned in the previous sections, a set-up allowing to assess the performances of polymer valves and overall artificial sphincters is necessary. This set-up should be able to simulate the hydrodynamic conditions featured in vivo and to evaluate the pressure profiles and the fluid-dynamic parameters of the tested devices.
O.5) Methodologies to evaluate the interaction between materials and urine.
Resistance to urine is a fundamental feature of the components that will constitute the artificial sphincters (especially for endo-urethral versions). In order to evaluate this resistance, methodologies mimicking in vitro conditions of a prolonged exposure of materials to urine and quantifying the response of these materials, in terms of quantity and type of encrustations and possible variations of the mechanical features, will be developed.
O.6) Engineering activity and CE certification.
The engineering activity includes a first phase for the identification of simple, reliable and sustainable manufacturing and assembly processes, and a second phase for the preparation of the documentation needed to apply for the CE certification of the endo-urethral device developed in the objective 1. Appropriate industrial actors for developing – with tracked and certified processes – the components of the artificial sphincters will be approached.
O.7) Activation of a clinical evaluation.
The experimentation will focus on the most promising system among those described. A clinical evaluation is planned on carefully selected patients.
O.8) Scientific dissemination and industrial promotion.
The dissemination of results is carried out at national and international level, through participation in events with opinion leaders in the sector and participation in medical device exhibitions. We plan to set-up a start-up company that can ensure the technology transfer of the overall process.