Higher Computed Tomography (CT) Scan Resolution Improves Accuracy of Patient-specific Mandibular Models When Compared to Cadaveric Gold Standard.

BACKGROUND: 3D-printed patient-specific anatomical models are becoming an increasingly popular tool for planning reconstructive surgeries to treat oral cancer. Currently there is a lack of information regarding model accuracy, and how the resolution of the computed tomography (CT) scan affects the accuracy of the final model. PURPOSE: The primary objective of this study was to determine the CT z-axis resolution necessary in creating a patient specific mandibular model with clinically acceptable accuracy for global bony reconstruction. This study also sought to evaluate the effect of the digital sculpting and 3D printing process on model accuracy. STUDY DESIGN: This was a cross-sectional study using cadaveric heads obtained from the Ohio State University Body Donation Program. INDEPENDENT VARIABLES: The first independent variable is CT scan slice thickness of either 0.675 , 1.25, 3.00, or 5.00 mm. The second independent variable is the three produced models for analysis (unsculpted, digitally sculpted, 3D printed). MAIN OUTCOME VARIABLE: The degree of accuracy of a model as defined by the root mean square (RMS) value, a measure of a model's discrepancy from its respective cadaveric anatomy. ANALYSES: All models were digitally compared to their cadaveric bony anatomy using a metrology surface scan of the dissected mandible. The RMS value of each comparison evaluates the level of discrepancy. One-way ANOVA tests (P < .05) were used to determine statistically significant differences between CT scan resolutions. Two-way ANOVA tests (P < .05) were used to determine statistically significant differences between groups. RESULTS: CT scans acquired for 8 formalin-fixed cadaver heads were processed and analyzed. The RMS for digitally sculpted models decreased as slice thickness decreased, confirming that higher resolution CT scans resulted in statistically more accurate model production when compared to the cadaveric gold standard. Furthermore, digitally sculpted models were significantly more accurate than unsculpted models (P < .05) at each slice thickness. CONCLUSIONS: Our study demonstrated that CT scans with slice thicknesses of 3.00 mm or smaller created statistically significantly more accurate models than models created from slice thicknesses of 5.00 mm. The digital sculpting process statistically significantly increased the accuracy of models and no loss of accuracy through the 3D printing process was observed.

The Larry Tube: Customized 3D Printed Laryngectomy Tubes Following Total Laryngectomy.

OBJECTIVE: To determine whether a custom laryngectomy tube can improve airway symptoms in total laryngectomy patients with atypical anatomy who are unable to use commercial laryngectomy tubes. Furthermore, to exemplify the power of customizable 3D printed medical devices when combined with the expanded access pathway through the FDA. METHODS: A custom-fabricated laryngectomy tube, manufactured at in-house clinical engineering labs, was utilized for each patient following typical laryngectomy tube protocols. All participants had previously undergone a total laryngectomy. Patients were selected based on critical airway obstruction posing potentially life-threatening scenarios while using commercially available laryngectomy tubes. RESULTS: For all patients involved, there were no further airway obstruction complications or events, and they reported a subjective, significant improvement in comfort after placement of the custom laryngectomy tube. CONCLUSION: Custom laryngectomy tubes can provide patients with atypical anatomy relief from airway obstructions and improve comfort when commercial options fail to address the anatomic restriction. The process used to develop custom laryngectomy tubes may be relevant for other diseases and patients with atypical anatomies through the expanded access pathway.

Use of 3-dimensional printing at the point-of-care to manage a complex wound in hemifacial necrotizing fasciitis: a case report.

BACKGROUND: Complex facial wounds can be difficult to stabilize due to proximity of vital structures. We present a case in which a patient-specific wound splint was manufactured using computer assisted design and three-dimensional printing at the point-of-care to allow for wound stabilization in the setting of hemifacial necrotizing fasciitis. We also describe the process and implementation of the United States Food and Drug Administration Expanded Access for Medical Devices Emergency Use mechanism. CASE PRESENTATION: A 58-year-old female presented with necrotizing fasciitis of the neck and hemiface. After multiple debridements, she remained critically ill with poor vascularity of tissue in the wound bed and no evidence of healthy granulation tissue and concern for additional breakdown towards the right orbit, mediastinum, and pretracheal soft tissues, precluding tracheostomy placement despite prolonged intubation. A negative pressure wound vacuum was considered for improved healing, but proximity to the eye raised concern for vision loss due to traction injury. As a solution, under the Food and Drug Administration's Expanded Access for Medical Devices Emergency Use mechanism, we designed a three-dimensional printed, patient-specific silicone wound splint from a CT scan, allowing the wound vacuum to be secured to the splint rather than the eyelid. After 5 days of splint-assisted vacuum therapy, the wound bed stabilized with no residual purulence and developed healthy granulation tissue, without injury to the eye or lower lid. With continued vacuum therapy, the wound contracted to allow for safe tracheostomy placement, ventilator liberation, oral intake, and hemifacial reconstruction with a myofascial pectoralis muscle flap and a paramedian forehead flap 1 month later. She was eventually decannulated and at six-month follow-up has excellent wound healing and periorbital function. CONCLUSIONS: Patient-specific, three-dimensional printing is an innovative solution that can facilitate safe placement of negative pressure wound therapy adjacent to delicate structures. This report also demonstrates feasibility of point-of-care manufacturing of customized devices for optimizing complex wound management in the head and neck, and describes successful use of the United States Food and Drug Administration's Expanded Access for Medical Devices Emergency Use mechanism.

The role of computer aided design/computer assisted manufacturing (CAD/CAM) and 3- dimensional printing in head and neck oncologic surgery: A review and future directions.

Microvascular free flap reconstruction has remained the standard of care in reconstruction of large tissue defects following ablative head and neck oncologic surgery, especially for bony structures. Computer aided design/computer assisted manufacturing (CAD/CAM) and 3-dimensionally (3D) printed models and devices offer novel solutions for reconstruction of bony defects. Conventional free hand techniques have been enhanced using 3D printed anatomic models for reference and pre-bending of titanium reconstructive plates, which has dramatically improved intraoperative and microvascular ischemia times. Improvements led to current state of the art uses which include full virtual planning (VP), 3D printed osteotomy guides, and patient specific reconstructive plates, with advanced options incorporating dental rehabilitation and titanium bone replacements into the primary surgical plan through use of these tools. Limitations such as high costs and delays in device manufacturing may be mitigated with in house software and workflows. Future innovations still in development include printing custom prosthetics, 'bioprinting' of tissue engineered scaffolds, integration of therapeutic implants, and other possibilities as this technology continues to rapidly advance. This review summarizes the literature and serves as a summary guide to the historic, current, advanced, and future possibilities of 3D printing within head and neck oncologic surgery and bony reconstruction. This review serves as a summary guide to the historic, current, advanced, and future roles of CAD/CAM and 3D printing within the field of head and neck oncologic surgery and bony reconstruction.

From bottle to microplastics: Can we estimate how our plastic products are breaking down?

Microplastics (MPs) have become an emerging new pollutant of rising concern due to the exponential growth of plastics in consumer products. Most MP and nanoplastic pollution comes from the fragmentation of plastics through mechanical stress, chemical reactions and biological degradation that occurs during use and after disposal. Models predicting the generation and behavior of MP in the environment are developing, however there is lack of data to predict the rates of MP generation as a function of the abrasive forces. A method to deliver scalable, quantitative release rates of MPs during mechanical stress throughout a plastic's life cycle (e.g., sanding, chewing, river and ocean disposal) is described. A custom abrasion machine was built with features to provide data to calculate power input. The generation rate of MPs through abrasion was tested for the following 3D printed polymers: polylactic acid (PLA), polycarbonate (PC), thermoplastic polyurethane 85A (TPU), polyethylene glycol terephthalate (PETG), high-impact polystyrene (HIPS), and nylon. Each material underwent tensile strength material tests to identify which mechanical properties drive their abrasion rate. Abrasion rate was not observed to correlate to macroscopic mechanic properties. Results indicate that the order of abrasion from most to least were HIPS, nylon, PC, PLA, PETG, and then TPU. This study will help comprehend and provide data to understand generation rates of MPs from consumer plastic products and macro-plastic debris. This will be instrumental in helping to better understand the release of MPs and nanoplastics into the environment and to provide data for fate and transport models, especially in order to predict the amount of plastic entering water systems. MP generation rates and power inputs can be correlated with each plastic's use to inform which release the most MPs and how to better change these products in order to reduce pollution in water sources.

Bioinspired Mineral-Organic Bioresorbable Bone Adhesive.

Bioresorbable bone adhesives have potential to revolutionize the clinical treatment of the human skeletal system, ranging from the fixation and osteointegration of permanent implants to the direct healing and fusion of bones without permanent fixation hardware. Despite an unmet need, there are currently no bone adhesives in clinical use that provide a strong enough bond to wet bone while possessing good osteointegration and bioresorbability. Inspired by the sandcastle worm that creates a protective tubular shell around its body using a proteinaceous adhesive, a novel bone adhesive is introduced, based on tetracalcium phosphate and phosphoserine, that cures in minutes in an aqueous environment and provides high bone-to-bone adhesive strength. The new material is measured to be 10 times more adhesive than bioresorbable calcium phosphate cement and 7.5 times more adhesive than non-resorbable poly(methyl methacrylate) bone cement, both of which are standard of care in the clinic today. The bone adhesive also demonstrates chemical adhesion to titanium approximately twice that of its adhesion to bone, unlocking the potential for adherence to metallic implants during surrounding bony incorporation. Finally, the bone adhesive is shown to demonstrate osteointegration and bioresorbability over a 52-week period in a critically sized distal femur defect in rabbits.