Restricted mouth opening (trismus) is one of the most common complications following head and neck cancer treatment. Early initiation of mouth-opening exercises is crucial for preventing or minimizing trismus. Current methods for these exercises predominantly involve finger exercises and traditional mouth-opening training devices. Our research group successfully designed an intelligent mouth-opening training device (IMOTD) that addresses the limitations of traditional home training methods, including the inability to quantify mouth-opening exercises, a lack of guided training resulting in temporomandibular joint injuries, and poor training continuity leading to poor training effect. For this device, an interactive remote guidance mode is introduced to address these concerns. The device was designed with a focus on the safety and effectiveness of medical devices. The accuracy of the training data was verified through piezoelectric sensor calibration. Through mechanical analysis, the stress points of the structure were identified, and finite element analysis of the connecting rod and the occlusal plate connection structure was conducted to ensure the safety of the device. The findings support the effectiveness of the intelligent device in rehabilitation through preclinical experiments when compared with conventional mouth-opening training methods. This intelligent device facilitates the quantification and visualization of mouth-opening training indicators, ensuring both the comfort and safety of the training process. Additionally, it enables remote supervision and guidance for patient training, thereby enhancing patient compliance and ultimately ensuring the effectiveness of mouth-opening exercises.

Little research has been reported on evaluating the safety of the fixation construct in cervical kyphosis correction. In this study, we proposed a principal-strain criterion to evaluate the safety of the fixation construct and validated the modeling method against a retrospective case of anterior cervical discectomy fusion (ACDF). From C2 to T2 vertebra bodies, fixation instruments were reconstructed and positioned as per postoperative computed tomography (CT) scans. Head weight (HW) and various moments estimated from isometric strength data were imposed onto the C2. The postoperative stability of non-surgical segments, deformations surrounding the screw trajectories, and contact slipping on zygapophysial joints were analyzed. The model was validated against the reality that the patient had a good fusion and deformity correction. The ACDF restricted the range of motions (ROMs) of cervical segments and lent stability to vertebra fusion, no failure was found in the finite element (FE) model of cervical vertebrae. The deformation surrounding the screw trajectories were concentrated to the lateral sides of trajectories, recommending that the shape of the anterior cervical plate conforming to the curvature of the vertebra and screws fully inserted into vertebrae reduced the deformation concentration around the screw trajectories.