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.

3D-Printed Simulation Device for Orbital Surgery.

OBJECTIVES: Orbital surgery is a challenging procedure because of its complex anatomy. Training could especially benefit from dedicated study models. The currently available devices lack sufficient anatomical representation and realistic soft tissue properties. Hence, we developed a 3D-printed simulation device for orbital surgery with tactual (haptic) correct simulation of all relevant anatomical structures. DESIGN, SETTING, AND PARTICIPANTS: Based on computed tomography scans collected from patients treated in a third referral center, the hard and soft tissue were segmented and virtually processed to generate a 3D-model of the orbit. Hard tissue was then physically realized by 3D-printing. The soft tissue was manufactured by a composite silicone model of the nucleus and the surrounding tissue over a negative mold model also generated by 3D-printing. The final model was evaluated by a group of 5 trainees in oral and maxillofacial surgery (1) and a group of 5 consultants (2). All participants were asked to reconstruct an isolated orbital floor defect with a titanium implant. A stereotactic navigation system was available to all participants. Their experience was evaluated for haptic realism, correct representation of surgical approach, general handling of model, insertion of implant into the orbit, placement and fixation of implant, and usability of navigated control. The items were evaluated via nonparametric statistics (1 [poor]-5 [good]). RESULTS: Group 1 gave an average mark of 4.0 (±0.9) versus 4.6 (±0.6) by group 2. The haptics were rated as 3.6 (±1.1) [1] and 4.2 (±0.8) [2]. The surgical approach was graded 3.7 (±1.2) [1] and 4.0 (±1.0) [2]. Handling of the models was rated 3.5 (±1.1) [1] and 4 (±0.7) [2]. The insertion of the implants was marked as 3.7 (±0.8) [1] and 4.2 (±0.8) [2]. Fixation of the implants was also perceived to be realistic with 3.6 (±0.9) [1] and 4.2 (±0.45) [2]. Lastly, surgical navigation was rated 3.8 (±0.8) [1] and 4.6 (±0.56) [2]. CONCLUSION: In this project, all relevant hard and soft tissue characteristics of orbital anatomy could be realized. Moreover, it was possible to demonstrate that the entire workflow of an orbital procedure may be simulated. Hence, using this model training expenses may be reduced and patient security could be enhanced.

Model-based segmentation in orbital volume measurement with cone beam computed tomography and evaluation against current concepts.

PURPOSE: Objective determination of the orbital volume is important in the diagnostic process and in evaluating the efficacy of medical and/or surgical treatment of orbital diseases. Tools designed to measure orbital volume with computed tomography (CT) often cannot be used with cone beam CT (CBCT) because of inferior tissue representation, although CBCT has the benefit of greater availability and lower patient radiation exposure. Therefore, a model-based segmentation technique is presented as a new method for measuring orbital volume and compared to alternative techniques. METHODS: Both eyes from thirty subjects with no known orbital pathology who had undergone CBCT as a part of routine care were evaluated (n = 60 eyes). Orbital volume was measured with manual, atlas-based, and model-based segmentation methods. Volume measurements, volume determination time, and usability were compared between the three methods. Differences in means were tested for statistical significance using two-tailed Student's t tests. RESULTS: Neither atlas-based (26.63 ± 3.15 mm(3)) nor model-based (26.87 ± 2.99 mm(3)) measurements were significantly different from manual volume measurements (26.65 ± 4.0 mm(3)). However, the time required to determine orbital volume was significantly longer for manual measurements (10.24 ± 1.21 min) than for atlas-based (6.96 ± 2.62 min, p < 0.001) or model-based (5.73 ± 1.12 min, p < 0.001) measurements. CONCLUSION: All three orbital volume measurement methods examined can accurately measure orbital volume, although atlas-based and model-based methods seem to be more user-friendly and less time-consuming. The new model-based technique achieves fully automated segmentation results, whereas all atlas-based segmentations at least required manipulations to the anterior closing. Additionally, model-based segmentation can provide reliable orbital volume measurements when CT image quality is poor.