BACKGROUND AND OBJECTIVES

Mouth retractors are essential in ensuring efficient yet safe exposure of the oral cavity and oropharynx. However, when applied improperly or haphazardly, retractors can cause tissue injuries and compromise patient safety. In addition, there are gaps in the usability of existing designs. This study aimed to identify the issues encountered by otorhinolaryngology surgeons in the use of commercially available mouth retractors, design and fabricate an improved retractor, and explore the use of additive manufacturing (popularly known as 3D printing) for retractor prototyping.

The study used the United States Food and Drug Administration (US FDA) Design Control as its framework. End-user requirements from otorhinolaryngologists were collected through key informant interviews. Results were organized into a Design Input template which was used to guide the design and development process. Prototype designs were iteratively created using computer-aided design software and 3D printing. Once design specifications were satisfied, a beta prototype was fabricated and given to another cohort of otorhinolaryngologists. The participants assessed the usability of the beta prototype. System Usability Scale (SUS) was used to quantify participant's feedback.

Five designs were created in the course of the study. The final prototype was fabricated using a Stereolithography (SLA) 3D printer. Several features were developed to address user requirements. The primary modification was to make the retractor modular to facilitate easier and shorter mounting and assembly. Gingival injury was addressed with the replacement of the maxillary alveolus hook with support bars. Five participants evaluated the beta prototype which received a mean SUS score of 75, well above the 50th percentile threshold.

This study demonstrates the applicability of the US FDA Design Control Process in the local setting to improve the mouth retractor design. Clinical and ergonomic issues were identified and design solutions were proposed and some have been implemented in a low-fidelity prototype. Results of the small-scale usability test suggest that the present form factor can be the basis for further iterations. Future studies can implement the proposed features to address other clinical and ergonomic needs.

OBJECTIVE: To compare the effectiveness of O-arm navigation and C-arm navigation for guiding percutaneous long sacroiliac screws in treatment of Denis type Ⅱ sacral fractures. METHODS: A retrospective study was conducted on clinical data of the 46 patients with Denis type Ⅱ sacral fractures between April 2021 and October 2022. Among them, 19 patients underwent O-arm navigation assisted percutaneous long sacroiliac screw fixation (O-arm navigation group), and 27 patients underwent C-arm navigation assisted percutaneous long sacroiliac screw fixation (C-arm navigation group). There was no significant difference in gender, age, causes of injuries, Tile classification of pelvic fractures, combined injury, the interval from injury to operation between the two groups ( P>0.05). The intraoperative preparation time, the placement time of each screw, the fluoroscopy time of each screw during placement, screw position accuracy, the quality of fracture reduction, and fracture healing time were recorded and compared, postoperative complications were observed. Pelvic function was evaluated by Majeed score at last follow-up. RESULTS: All operations were completed successfully, and all incisions healed by first intention. Compared to the C-arm navigation group, the O-arm navigation group had shorter intraoperative preparation time, placement time of each screw, and fluoroscopy time, with significant differences ( P<0.05). There was no significant difference in screw position accuracy and the quality of fracture reduction ( P>0.05). There was no nerve or vascular injury during screw placed in the two groups. All patients in both groups were followed up, with the follow-up time of 6-21 months (mean, 12.0 months). Imaging re-examination showed that both groups achieved bony healing, and there was no significant difference in fracture healing time between the two groups ( P>0.05). During follow-up, there was no postoperative complications, such as screw loosening and breaking or loss of fracture reduction. At last follow-up, there was no significant difference in pelvic function between the two groups ( P>0.05). CONCLUSION Compared with the C-arm navigation, the O-arm navigation assisted percutaneous long sacroiliac screws for the treatment of Denis typeⅡsacral fractures can significantly shorten the intraoperative preparation time, screw placement time, and fluoroscopy time, improve the accuracy of screw placement, and obtain clearer navigation images.
Humans ; Fracture Fixation, Internal/methods* ; Retrospective Studies ; Imaging, Three-Dimensional ; Bone Screws ; Surgery, Computer-Assisted ; Tomography, X-Ray Computed ; Spinal Fractures/surgery* ; Fractures, Bone/surgery* ; Pelvic Bones/injuries* ; Postoperative Complications ; Neck Injuries

Background and Objective: To design and fabricate a suction port adapter to use various sizes of suction cannulas with a wireless otoendoscope enabling ear cleaning under endoscopic guidance demonstrated using an ear examination simulator. Methods: Design: Instrument Innovation. Setting: Tertiary Private Training Hospital. Patient: Ear Examination Simulator. Results: The fabricated suction port adapters were able to hold the wireless otoendoscope and suction cannulas together, allowing simultaneous inspection of the ear canal and suctioning of ear canal debris using the Ear Examination Simulator. Conclusion Our prototype 3D-printed suction port adapters for a wireless otoendoscope may improve ear cleaning by enhancing the accuracy of suctioning debris and decreasing duration since they hold the suction cannulas in place under endoscopic guidance. They may aid ENT physicians in easier visualization and simultaneous ear cleaning of patients and improve ear cleaning techniques and times, especially among less experienced physicians, but actual clinical trials are needed to confirm this.
Printing, Three-Dimensional ; Cerumen ; Otoscopy

Background: In this study, 3D printed floating tablet devices for Metronidazole (MTZ) were developed to prolong its exposure with Helicobacter pylori and eradicate it from causing peptic ulcer Objectives: To utilize Quality by Design (QbD) in the development of the tablet devices through Fused Deposition Modelling (FDM) 3D printing. This aimed to develop and construct optimized design dimensions of tablet devices subject for characterization. Methodology: Tablet designs were established using QbD, Design Failure Mode Effect and Analysis (DFMEA) and 2 factorial design. Four floating tablets devices were developed through FDM 3D printing using Polyvinyl alcohol (PVA) filament. Characterization tests determined their dimensions, density, floating mechanism, in vitro dissolution rate, drug release kinetics, surface morphology, infill and thermal characteristics. Significance of the QbD model was also assessed. Results: Density of all devices were less than 1.004 g/cm . The floating Lag time (FLT) showed instant floatation and Total Floating Time (TFT) lasted for an average of 1 hour. Drug release kinetics show Korsmeyer-Peppas kinetics. Thermal characteristics fall within o o 186.12 C-187.27 C. 3D CTX-ray results show accuracy of printing 3D renders. Tablet device 3 exhibited the best surface morphology, longest floating time and slowest drug release. Conclusion The study successfully developed 3D printed floating tablet devices for Metronidazole with sustained release mechanism. Thus, utilizing QbD in pre-formulation studies using novel technology is essential in optimizing drug dosage forms. Plots from Design Expert Software show the significant design models.
Printing, Three-Dimensional

The registration of preoperative magnetic resonance (MR) images and intraoperative ultrasound (US) images is very important in the planning of brain tumor surgery and during surgery. Considering that the two-modality images have different intensity range and resolution, and the US images are degraded by lots of speckle noises, a self-similarity context (SSC) descriptor based on local neighborhood information was adopted to define the similarity measure. The ultrasound images were considered as the reference, the corners were extracted as the key points using three-dimensional differential operators, and the dense displacement sampling discrete optimization algorithm was adopted for registration. The whole registration process was divided into two stages including the affine registration and the elastic registration. In the affine registration stage, the image was decomposed using multi-resolution scheme, and in the elastic registration stage, the displacement vectors of key points were regularized using the minimum convolution and mean field reasoning strategies. The registration experiment was performed on the preoperative MR images and intraoperative US images of 22 patients. The overall error after affine registration was (1.57 ± 0.30) mm, and the average computation time of each pair of images was only 1.36 s; while the overall error after elastic registration was further reduced to (1.40 ± 0.28) mm, and the average registration time was 1.53 s. The experimental results show that the proposed method has prominent registration accuracy and high computational efficiency.
Humans ; Imaging, Three-Dimensional/methods* ; Magnetic Resonance Imaging/methods* ; Ultrasonography/methods* ; Algorithms ; Surgery, Computer-Assisted/methods*

Magnetic resonance (MR) imaging is an important tool for prostate cancer diagnosis, and accurate segmentation of MR prostate regions by computer-aided diagnostic techniques is important for the diagnosis of prostate cancer. In this paper, we propose an improved end-to-end three-dimensional image segmentation network using a deep learning approach to the traditional V-Net network (V-Net) network in order to provide more accurate image segmentation results. Firstly, we fused the soft attention mechanism into the traditional V-Net's jump connection, and combined short jump connection and small convolutional kernel to further improve the network segmentation accuracy. Then the prostate region was segmented using the Prostate MR Image Segmentation 2012 (PROMISE 12) challenge dataset, and the model was evaluated using the dice similarity coefficient (DSC) and Hausdorff distance (HD). The DSC and HD values of the segmented model could reach 0.903 and 3.912 mm, respectively. The experimental results show that the algorithm in this paper can provide more accurate three-dimensional segmentation results, which can accurately and efficiently segment prostate MR images and provide a reliable basis for clinical diagnosis and treatment.
Male ; Humans ; Prostate/diagnostic imaging* ; Image Processing, Computer-Assisted/methods* ; Magnetic Resonance Imaging/methods* ; Imaging, Three-Dimensional/methods* ; Prostatic Neoplasms/diagnostic imaging*

Three-dimensional (3D) cell culture model is a system that co-culture carriers with 3D structural materials and different types of cells in vitro to simulate the microenvironment in vivo. This novel cell culture model has been proved to be close to the natural system in vivo. In the process of cell attachment, migration, mitosis and apoptosis, it could produce biological reactions different from that of monolayer cell culture. Therefore, it can be used as an ideal model to evaluate the dynamic pharmacological effects of active substances and the metastasis process of cancer cells. This paper compared and analyzed the different characteristics of cell growth and development under two-dimensional (2D) and 3D model culture and introduced the establishment method of 3D cell model. The application progress of 3D cell culture technology in tumor model and intestinal absorption model was summarized. Finally, the application prospect of 3D cell model in the evaluation and screening of active substance was revealed. This review is expected to provide reference for the development and application of new 3D cell culture models.
Cell Culture Techniques, Three Dimensional ; Cell Culture Techniques ; Apoptosis ; Cell Proliferation ; Technology

OBJECTIVE: To investigate the feasibility of MRI three-dimensional (3D) reconstruction model in quantifying glenoid bone defect by comparing with CT 3D reconstruction model measurement. METHODS: Forty patients with shoulder anterior dislocation who met the selection criteria between December 2021 and December 2022 were admitted as study participants. There were 34 males and 6 females with an average age of 24.8 years (range, 19-32 years). The injury caused by sports injury in 29 cases and collision injury in 6 cases, and 5 cases had no obvious inducement. The time from injury to admission ranged from 4 to 72 months (mean, 28.5 months). CT and MRI were performed on the patients' shoulder joints, and a semi-automatic segmentation of the images was done with 3D slicer software to construct a glenoid model. The length of the glenoid bone defect was measured on the models by 2 physicians. The intra-group correlation coefficient ( ICC) was used to evaluate the consistency between the 2 physicians, and Bland-Altman plots were constructed to evaluate the consistency between the 2 methods. RESULTS: The length of the glenoid bone defects measured on MRI 3D reconstruction model was (3.83±1.36) mm/4.00 (0.58, 6.13) mm for physician 1 and (3.91±1.20) mm/3.86 (1.39, 5.96) mm for physician 2. The length of the glenoid bone defects measured on CT 3D reconstruction model was (3.81±1.38) mm/3.80 (0.60, 6.02) mm for physician 1 and (3.99±1.19) mm/4.00 (1.68, 6.38) mm for physician 2. ICC and Bland-Altman plot analysis showed good consistency. The ICC between the 2 physicians based on MRI and CT 3D reconstruction model measurements were 0.73 [95% CI (0.54, 0.85)] and 0.80 [95% CI (0.65, 0.89)], respectively. The 95% CI of the difference between the two measurements of physicians 1 and 2 were (-0.46, 0.49) and (-0.68, 0.53), respectively. CONCLUSION The measurement of glenoid bone defect based on MRI 3D reconstruction model is consistent with that based on CT 3D reconstruction model. MRI can be used instead of CT to measure glenoid bone defects in clinic, and the soft tissue of shoulder joint can be observed comprehensively while reducing radiation.
Male ; Female ; Humans ; Young Adult ; Adult ; Imaging, Three-Dimensional/methods* ; Tomography, X-Ray Computed/methods* ; Joint Instability ; Shoulder Joint/diagnostic imaging* ; Shoulder Dislocation ; Magnetic Resonance Imaging/methods*

OBJECTIVE: To review the research progress of the feasibility of a new treatment method for atrophic rhinitis (ATR) based on tissue engineering technology (seed cells, scaffold materials, and growth factors), and provide new ideas for the treatment of ATR. METHODS: The literature related to ATR was extensively reviewed. Focusing on the three aspects of seed cells, scaffold materials, and growth factors, the recent research progress of ATR treatment was reviewed, and the future directions of tissue engineering technology to treat ATR were proposed. RESULTS: The pathogenesis and etiology of ATR are still unclear, and the effectiveness of the current treatments are still unsatisfactory. The construction of a cell-scaffold complex with sustained and controlled release of exogenous cytokines is expected to reverse the pathological changes of ATR, promoting the regeneration of normal nasal mucosa and reconstructing the atrophic turbinate. In recent years, the research progress of exosomes, three-dimensional printing, and organoids will promote the development of tissue engineering technology for ATR. CONCLUSION Tissue engineering technology can provide a new treatment method for ATR.
Humans ; Tissue Engineering/methods* ; Tissue Scaffolds ; Rhinitis, Atrophic ; Printing, Three-Dimensional ; Cytokines

OBJECTIVE: To explore correlation between femoral mechanical axis and Blumensaat line (FMBL) angle of knee joint (angle between Blumensaat line and femoral mechanical axis), α angle (angle between Blumensaat line and axis of distal femur in sagittal plane) on EOS biplane imaging and non-contact anterior cruciate ligament(ACL) injury, and evaluate angle for its accuracy in predicting the populations prone to non-contact ACL injury. METHODS: From February 2018 to October 2020, EOS imaging and clinical data from 88 patients (176 knees) with unilateral non-contact ACL injury were retrospectively analyzed, including 53 males and 35 females, aged from 18 to 45 years old with an average of (30.3±6.2) years old, 48 patients on the left side and 40 patients on the right side. The patients were divided into ACL-affected group and ACL-health group according to side of ACL injuries, and 51 patients (51 knees) with non-ACL identified from EOS database were included in normal control group, including 28 males and 23 females, aged from 20 to 44 years old with an average of (31.6±5.5) years old, 26 patients on the left side and 25 patients on the right side. Full-length EOS imaging of skeleton extremitatis inferioris among three groups were reconstructed to 3D images of skeletal system with EOS software, and then FMBL angle and α angle were measured on the images. Univariate binary Logistic regression analysis was performed to determine the influence of the univariate(FMBL angle or α angle) on ACL status(normal or torn). And the angle cutoff value for univariate was selected based on receiver operating characteristics curve (ROC) to got the best accuracy. RESULTS: There was no statistically significant difference in age, gender and side distribution between ACL-injured group and normal control group(P>0.05). Statistical analyses (one-way ANOVA) indicated no significant difference in FMBL angle between ACL-injured knee group (32.8±2.3)° and ACL-injured contralateral knee group(32.5±2.3)°(P>0.05), but the values between two groups were significantly lower than that in normal control group (37.0±2.0)°(P<0.001). There was no statistically significant difference in α angle among three groups (P>0.05). Univariate binary Logistic regression analysis demonstrated that FMBL angle was risk factor for non-contact ACL injury[OR=0.433, 95%CI(0.330, 0.569), P<0.001]. The area under ROC curve for FMBL angle was 0.909[95%CI(0.861, 0.958), P<0.001], and the sensitivity and specificity were 70.5% and 98.0% respectively, cut-off value was 33.7°. CONCLUSION FMBL angle formed by Blumensaat line and femoral mechanical axis is one of the risk factors for non-contact ACL injury and has good predictive accuracy. The general population with FMBL angle below 33.7° may be increased risk for ACL injury.
Male ; Female ; Humans ; Adolescent ; Young Adult ; Adult ; Middle Aged ; Anterior Cruciate Ligament Injuries/diagnostic imaging* ; Retrospective Studies ; Imaging, Three-Dimensional ; Magnetic Resonance Imaging/methods* ; Anterior Cruciate Ligament/diagnostic imaging* ; Knee Joint/diagnostic imaging*