FiDiS

F.I.Di.S. Project has seen the participation of four small Medium Enterprises and the Polytechnic of Turin. The scope of the project is human and veterinary traumatology. The main objective was the realization of an innovative internal fixator for the solidarization of fractures, composed of two parts: a right support with housing of screws to be anchored to the bone in a part of the fractured stump, and a sliding guide that is fixed by screws in the other part of the bone stump. The innovative features of the project are mainly two.

In the first place, the aim of the project was to make sure that the right support and the sliding guide are bound together while maintaining a single degree of freedom, that of the reciprocal sliding between the right support and the sliding guide, in order to allow a reciprocal movement between the two components limited to a few millimeters. This sliding should allow an early healing thanks to the solidarization of the fracture by second intention, soliciting the production of new bone tissue around the fracture rhyme, with a relative sliding between the two components decreasing with the progress of the solidarization of the fracture and with the granting of the load to the patient.

The second objective, particularly innovative and singular, was to allow to monitor the extent of the sliding between the two components of the internal dynamic fixator through an impedance sensor with integrated power supply. A user-friendly interface can be used on any computer station allows the simple reading of the acquired signal allowing the medical team to monitor the progress of the solidarity of the fracture without resorting to invasive diagnostics for the patient.

The secondary objectives of the project were the creation of an instrumentation and a surgical technique such as to allow a minimally invasive approach when implanting the dynamic internal fixator on the patient. All project objectives were achieved thanks to the close cooperation between the partners.

The prototypes of internal dynamic sensorized fixator for veterinary and human use met all the objectives and results expected at the beginning of the project. The solutions developed, following the resolution of the main difficulties that occurred during the project activities, are in many cases at least partially ready for industrial scale exploitation. Further developments of the results achieved are also being studied in order to try to optimise, where possible, the possibility of significantly reducing industrial costs, for example by using components already consolidated and present on the market as far as possible, in order to simplify the assembly steps of the sensor components and the sensor on the dynamic internal fixator.

It is being studied how to proceed in order to try to possibly submit the product produced to the CE marking with the consequent possibility of placing it on the market. The main difficulties lie in the substantial costs to be incurred for the performance of all the additional tests, complementary to those carried out within the project, necessary to complete the mandatory activities for the preparation of a complete technical dossier. There is a lack of market references using technologies similar to those developed during the project by the partnership in the same sector, since it is an implantable medical device that due to the presence of integrated power supply and signal transmission, make it also active, expanding the competence for obtaining the CE marking potentially to two directives and not only one.

All the components of the project partnership intend to intensify the commercial relations for the exploitation of the results that have been achieved in a shared way and with active participation in all project activities.

Finally, the device designed, as an implantable “displacement meter”, lends itself to application on other fronts that may be identified in the future by the FIdis project team. The collaboration from the partners will not prescind, thanks to the enormous advantages characterized inside of the plan, from the involvement of the Polytechnic of Turin, that although for own nature is not interested to the economic exploitation of the reached results, may be a valid support to spread the scientific value of the results that the partnership has achieved and intends to further develop, through publications in journals of international prestige of the solutions found.

PROJECT NUMBERS

• Other Private Partners : Medicomp S.r.l., Traumavet S.r.l., Laboratori Biomicron S.r.l.
• Other Public Partners: Polytechnic of Turin
• Total number of partners: 5
• Number of dependent researchers (permanent, fixed-term and cocopro) involved:17
• Duration in months:36
• Total budget: 1.118.580,00
• Funding: 559.290,00
• Number of scientific publications: 0
• Number of presentations at conferences and seminars: 2
• Number of patents filed: 0
• Number of permanent, fixed-term and cocopro jobs created: 3
• Number of jobs maintained at project end:3
• Number of public researchers involved:5