Design and evaluation of a modular instrument for endoscopic thyroid surgery
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Abstract
Introduction- The global incidence of thyroid cancer has risen significantly, prompting the development of innovative surgical techniques. Transoral thyroidectomy offers a scarless alternative, with the transoral endoscopic thyroidectomy vestibular approach (TOETVA) showing promising results. However, CO2 insufflation during TOETVA can lead to fatal complications. To address these issues, researchers have explored gasless TOETVA methods. Our study introduces a modular articulating retractor integrated with a 5mm camera system, aimed at minimizing CO2-related complications while preserving the benefits of the conventional procedure.
Method- Through a design process comprising problem definition, ideation, and solution creation. A detailed digital CAD design is developed based on force measurements obtained from a preliminary cadaver study. Subsequently, a functional prototype is created and subjected to pre-clinical testing using Thiel-embalmed and fresh frozen cadavers.
Result- Force tests determined a mean force of 4.73N across cadavers, with 5.29N necessary for optimal skin elevation. SolidWorks simulation indicated maximum stresses of 128.10 MPa and 113.80 MPa in articulated and horizontal positions. Backdrivability of articulation occurred at approximately 4N applied force. Assembly and disassembly tasks demonstrated mostly normal distribution, with significant differences observed between initial and final assembly attempts. Despite successful procedure performance, challenges included endoscope removal limitations and partial functionality constraints during articulation within cadavers. Overall removal time averaged 3.2s, with a maximum of 4.1s.
Conclusion- The gasless TOETVA procedure was performed successfully with sufficient visualization for the surgeon. While achieving three of our four objectives, including the design and compatibility with standard endoscopic cameras, limitations prevented direct comparison with conventional CO2-based TOETVA methods. Despite this setback, the initial incorporation of our instrument into surgical procedures demonstrates promise. However, further research is imperative to compare its performance against conventional methods, validating its efficacy and potential in clinical practice.