MaxillOsteo

Osteotomies are carried out by many surgeons to cut and/or shape bone and cartilage tissues in order to modify their geometry. The use of osteotomes has been reported in various surgical fields including maxillo-facial (e.g. rhinoplasty), dental (e.g. Summers) and orthopedic (e.g. spine or tibiay) surgeries. Despite their routine clinical use, there remain risks of surgical failure. One of the main difficulties lies in that visual control is often not possible because the osteotome tip is hidden by soft tissues. Dramatic consequences for the patient may be associated with uncontrolled crack propagation or with the osteotome crossing bone tissue, thus harming soft tissues located behind the region of interest. MaxillOseo aims at developing an innovative medical device to provide a real time decision support system in a patient-specific manner to be used during various kinds of osteotomies. We aim at achieving a market-ready prototype that will be validated in anatomical subjects. We will i) optimize the performances of the existing experimental set-up, ii) extend and adapt the technique validated in animal for the rhinoplasty to other types of surgeries, iii) develop and validate the device in anatomical subjects. These studies will be used to refine the signals processing analyses and validate the pre-clinical process. We aim at achieving an industrial development of the device by considering cost reduction and miniaturization, and by working on its regulatory pathways. We will develop reliable numerical simulations to mimic the measurement conditions in order to better understand the mechanisms involved during the impacts. The originality of MaxillOsteo lies in the development of a medical device bringing a quantification into a field where the surgeon proprioception is still widely employed in the operating room. We will develop a final prototype respecting all regulatory issues and adapted to the requirements of a use in a clinical environment. To do so, we will work on the measurement protocol and on the hardware (size and weight of the hammer, data processing, sensors, etc...). In order to reduce the number of experimental tests with anatomical subjects, numerical simulations will be used to improve the accuracy of the device. We will develop a reliable in silico model of the impact procedure for different osteotomies, which will allow the development of a signal processing algorithm involving machine learning algorithms to perform the inversion. The technological breakthrough consists in the development of a standalone decision-support system that will be made available to surgeons to help them realize various osteotomies in a patient-specific manner. The innovation is based on the possibility to obtain a quantitative information of the fragility of bone tissue located around the osteotome tip, which will allow the surgeon to adapt the number and amplitude of impacts. MaxillOsteo is based on the work of fundamental nature carried out by MSME and IMRB, which consists in the proof of concept obtained with a similar device. The translational character of the project is proven by the fact that its main objective is to bring this technique into the medical field. The approach introduced in the project presents the advantage of an easy integration of the device in the operating room since the method does not require any modification of the surgical procedure, thus maximizing the chances of massive adoption by the surgeons. The consortium brings together leading partners in their respective field. This Consortium is a balanced mix of partners from universities, research institutes, hospitals and SME that complement each other to cover a wide spectrum of scientific knowledge and technological innovation that the project relies on.