Concept of patient-specific shape memory implants for the treatment of orbital floor fractures.

PURPOSE: We will aim to develop implants made of a Ni-Ti shape memory alloy which can be applied for the treatment of midface fractures, such as isolated orbital floor fractures. These can then be implanted in a compressed form and unfold automatically in the body. With the help of newly developed application instruments, the implants can be applied along transnasal and transantral approaches into the maxillary sinus. Our objective is to evaluate the operation process and the functionality of these implants, already in a pre-investigation by an experienced surgeon on a phantom.

METHODS: The functionality of the surgical procedure and an implant prototype were both evaluated with the help of a realistic phantom. The minimally invasive application was carried out using the transnasal and transantral approach. Instruments and implant were rated individually on a scale, from -2 (not at all) to +2 (very good) for vaious criteria, such as the implants functionality or the ergonomics of the entire procedure. For a geometric comparison between the manufactured implant and the planned target geometry, the implants were scanned by micro-computed tomography. CAD models were derived from the scans by using reverse engineering.

RESULTS: Both the implants and the application procedure were assessed as good; thus, the implant concept is suitable for further development.

CONCLUSIONS: Implants made of shape memory alloys could allow in the future and allow less invasive access to treat orbital floor fractures. The implant design has to be modified that the implant can be stabilized and fixed with screws or a suture to avoid dislocation or implant loosening. The complication rates and risks of conventional orbital reconstructions should be lowered by this new method.