Endotracheal Intubation is a common medical procedure conducted over 15 million times annually in the U.S. that carries risks of laryngeal injuries from prolonged intubation. Some of the injuries include difficulty swallowing, coughing, severe sore throat, hoarseness, and vocal fold paralysis. Dr. Andrew Vahabzadeh-Hagh devised the Endotracheal Tube Support Clip (ETSC) to alleviate pressure on the posterior larynx caused by endotracheal tubes (ETTs). The ETSC induces a bend that mimics the throat's natural curvature, thus reducing injuries as a result of exerted forces on the larynx. To further enhance this clip, Dr. Vahabzadeh-Hagh requested improvements on the ETSC design with the intention of transitioning the manufacturing process from 3D printing to injection molding.
The objective of this project was to develop an optimized version of the ETSC. This involved enhancing the design of the ETSC for manufacturing, specifically for injection molding. Aside from creating an injection mold for cost-effective mass production, the ETSC had to be biocompatible and incorporate an emergency extraction method. The clip also had to be durable, user-friendly, and compatible with various ETT sizes.
The ETSC will continue to be made of BioMed Clear resin. It will continue to create and maintain a 90° bend on the ETT for over 72 hours on all ETT sizes. The inner diameter is 10.7 mm, with a thickness of 1.4 mm. On the proximal end tooth, there is an added appendage of 2.45 mm on the lower portion of the clip and an added appendage of 0.6 mm to the upper portion of the clip. The tooth sizes have been increased by 2 mm from the original design, securing the clip onto the ETT better. The middle tooth has a slant edge detail that provides a larger space for the clip to slip onto the tube. This final design has smooth leading edge to avoid damaging the pilot balloon cord. In case of an emergency a suture string can be tied through two holes on the back of the clip. Lastly the final design includes a slit on the back of the clip in order to provide a place for a radiopaque material to be added.
CAD of the Final Design
Image of the Final Design
Through physical testing the ETSC has shown that it is able to reach the functional requirements such as:
It's able to maintain the 90° bent shape on all ETT sizes.
It fits a variety of ETT sizes without damaging the tubes and or breaking when attached and detached.
It's able to be pulled with a suture string over 50 times without breaking.
The material is biocompatible.