Rapid Prototyping Techniques for the Development of a Take-Home Surgical Anastomosis Simulation Model.

OBJECTIVE: The objective of this paper is to describe the techniques and process of developing and testing a take-home surgical anastomosis simulation model. DESIGN: Through an iterative process, a simulation model was customized and designed to target specific skill development and performance objectives that focused on anastomotic techniques in thoracic surgery and consist of 3D printed and silicone molded components. Various manufacturing techniques such as silicone dip spin coating and injection molding have been described in this paper and explored as part of the research and development process. The final prototype is a low-cost, take-home model with reusable and replaceable components. SETTING: The study took place at a single-center quaternary care university-affiliated hospital. PARTICIPANTS: The participants included in the model testing were 10 senior thoracic surgery trainees who completed an in-person training session held during an annual hands- on thoracic surgery simulation course. Feedback was then collected in the form of an evaluation of the model from participants. RESULTS: All 10 participants had an opportunity to test the model and complete at least 1 pulmonary artery and bronchial anastomosis. The overall experience was rated highly, with minor feedback provided regarding the set- up and fidelity of the materials used for the anastomoses. Overall, the trainees agreed that the model was suitable for teaching advanced anastomotic techniques and expressed an interest in being able to use this model to practice skill development. CONCLUSIONS: Developed simulation model can be easily reduced, with customized components that accurately simulate real-life vascular and bronchial components suitable for training of anastomoses technique amongst senior thoracic surgery trainees.

Assessment of effectiveness and safety of thrombolytic therapy to pulmonary emboli by endobronchial ultrasound-guided transbronchial needle injection.

Objective: Endobronchial ultrasound-guided transbronchial needle injection (EBUS-TBNI) may effectively treat acute pulmonary embolisms (PEs). Here, we assessed the effectiveness of clot dissolution and safety of tissue plasminogen activator (t-PA) injection using EBUS-TBNI in a 1-week survival study of a porcine PE model. Methods: Six pigs with bilateral PEs were used: 3 for t-PA injection using EBUS-TBNI (TBNI group) and 3 for systemic administration of t-PA (systemic group). Once bilateral PEs were created, each 25 mg of t-PA injection using EBUS-TBNI for bilateral PEs (a total of 50 mg t-PA) and 100 mg of t-PA systemic administration was performed on day 1. Hemodynamic parameters, blood tests, and contrast-enhanced computed tomography scans were carried out at several time points. On day 7, pigs were humanely killed to evaluate the residual clot volume in the pulmonary arteries. Results: The average of percent change of residual clot volumes was significantly lower in the TBNI group than in the systemic group (%: systemic group 36.6 ± 22.6 vs TBNI group 9.6 ± 6.1, P < .01) on day 3. Considering the elapsed time, the average decrease of clot volume per hour at pre-t-PA to post t-PA was significantly greater in the TBNI group than in the systemic group (mm3/hour: systemic 68.1 ± 68.1 vs TBNI 256.8 ± 148.1, P < .05). No hemorrhage was observed intracranially, intrathoracically, or intraperitoneally on any contrast-enhanced computed tomography images. Conclusions: This study revealed that t-PA injection using EBUS-TBNI is an effective and safe way to dissolve clots.

Better safe than sorry? Results from an ex-vivo study demonstrate that the thulium fiber laser may cause eye injury without standard protection.

INTRODUCTION: We conducted a study using an ex-vivo porcine model to evaluate whether a thulium fiber laser (TFL) induces ocular injury in the context of inadvertent exposure to the laser beam. METHODS: A 365 µm TFL was positioned at a set distance (0 cm, 5 cm, 8 cm, and 10 cm) from a freshly harvested (<12 hours) porcine eyeball and the laser was activated for one second at select laser settings for lithotripsy (0.2 J at 50 Hz, 0.5 J at 20 Hz, and 1 J at 10 Hz) and soft tissue ablation (2 J at 10 Hz, 1 J at 50 Hz). The experiment was repeated with laser safety goggles and prescription eyeglasses. Thermal injury was assessed by histopathological analysis. RESULTS: Without eye protection, corneal injury was observed even at 10 cm away for one lithotripsy setting (1 J at 10 Hz) and both tissue ablation settings. All thermal injuries observed were superficial only, except for at 0 cm distance, where deep-layer injury was observed. Laser safety goggles offered complete protection regardless of setting or distance. Partial protection was demonstrated with prescription glasses: histopathological damage was observed for both soft tissue ablation settings and only at 0 cm for two lithotripsy settings (0.5 J at 20 Hz, 1 J at 10 Hz). CONCLUSIONS: The TFL can induce ocular injury at close distances and at higher power settings. The use of laser safety goggles confers complete protection while prescription eyeglasses confer partial protection. Further study is warranted.

Open ventilator evaluation framework: A synthesized database of regulatory requirements and technical standards for emergency use ventilators from Australia, Canada, UK, and US.

Development of emergency use ventilators has attracted significant attention and resources during the COVID-19 pandemic. To facilitate mass collaboration and accelerate progress, many groups have adopted open-source development models, inspired by the long history of open-source development in software. According to the Open-source Hardware Association (OSHWA), Open-source Hardware (OSH) is a term for tangible artifacts - machines, devices, or other physical things - whose design has been released to the public in such a way that anyone can make, modify, and use them. One major obstacle to translating the growing body of work on open-source ventilators into clinical practice is compliance with regulations and conformance with mandated technical standards for effective performance and device safety. This is exacerbated by the inherent complexity of the regulatory process, which is tailored to traditional centralized development models, as well as the rapid changes and alternative pathways that have emerged during the pandemic. As a step in addressing this challenge, this paper provides developers, evaluators, and potential users of emergency ventilators with the first iteration of a pragmatic, open-source assessment framework that incorporates existing regulatory guidelines from Australia, Canada, UK and USA. We also provide an example evaluation for one open-source emergency ventilator design. The evaluation process has been divided into three levels: 1. Adequacy of open-source project documentation; 2. Clinical performance requirements, and 3. Conformance with technical standards.

Development, manufacturing, and preliminary validation of a reusable half-face respirator during the COVID-19 pandemic.

INTRODUCTION: The COVID-19 pandemic has led to widespread shortages of N95 respirators and other personal protective equipment (PPE). An effective, reusable, locally-manufactured respirator can mitigate this problem. We describe the development, manufacture, and preliminary testing of an open-hardware-licensed device, the "simple silicone mask" (SSM). METHODS: A multidisciplinary team developed a reusable silicone half facepiece respirator over 9 prototype iterations. The manufacturing process consisted of 3D printing and silicone casting. Prototypes were assessed for comfort and breathability. Filtration was assessed by user seal checks and quantitative fit-testing according to CSA Z94.4-18. RESULTS: The respirator originally included a cartridge for holding filter material; this was modified to connect to standard heat-moisture exchange (HME) filters (N95 or greater) after the cartridge showed poor filtration performance due to flow acceleration around the filter edges, which was exacerbated by high filter resistance. All 8 HME-based iterations provided an adequate seal by user seal checks and achieved a pass rate of 87.5% (N = 8) on quantitative testing, with all failures occurring in the first iteration. The overall median fit-factor was 1662 (100 = pass). Estimated unit cost for a production run of 1000 using distributed manufacturing techniques is CAD $15 in materials and 20 minutes of labor. CONCLUSION: Small-scale manufacturing of an effective, reusable N95 respirator during a pandemic is feasible and cost-effective. Required quantities of reusables are more predictable and less vulnerable to supply chain disruption than disposables. With further evaluation, such devices may be an alternative to disposable respirators during public health emergencies. The respirator described above is an investigational device and requires further evaluation and regulatory requirements before clinical deployment. The authors and affiliates do not endorse the use of this device at present.