IP Required: Emory IP

Experience Required:

-Mechanical Design

Endotracheal intubation is a procedure performed by medical professionals to support an individual’s oxygenation, ventilation, and maintenance of airway (also known as airway protection). Regardless of the indication, the fundamental equipment is the same requiring the use of an endotracheal tube. This device has remained mostly unchanged for many years and has room for improvement, especially in times of malfunction.

Then endotracheal tube (ETT) is a plastic tube made of polyvinyl chloride (PVC) consistent of several different key components: tube, cuff, bevel, Murphy’s eye, and the connector along with several additional components needed to optimize its use (stylet, syringe for cuff/pilot balloon, universal 15 mm connector, end-tidal CO2 device). Though there are several areas for improvement in this device, one large and cumbersome issue resides in with the cuff and what needs to be done when it fails. 

The cuff is an inflatable balloon at the distal end of the ETT. It produces a seal against the tracheal wall preventing gastric contents from entering the trachea and facilitating the execution of positive pressure ventilation. The cuff inflates by attaching an appropriate size syringe (10 to 20 ml for adult ETT) to the pilot balloon (a small balloon external to body to estimate cuff pressure based on palpation alone). The ideal cuff pressure is at about 20cm H2O. A cuff leak should be suspected if the pilot balloon fails to hold air, an audible whistle is heard, or tidal volumes on the ventilator decrease. Herein lies the problem with current device setup. 

Despite there being no clear objective way to determine if a cuff leak is present or what the exact pressure the balloon is inflated to (an easy fix by medical device standards), a major problem is what happens when the cuff fails or ruptures. When this occurs, the patient requires a completely new ETT requiring a repeat intubation procedure conferring a lot of risk each time it is performed. This often means heavily sedating the patient again to suppress cough and gag reflexes (which can come with further hemodynamic compromises), removing the old ETT, and under direct laryngeal visualization replacing a new ETT. Additionally, if the patient has a challenging airway, being forced to repeat this procedure adds substantial additional risk. All this for a small part of this device to fail.

A new and improved ETT would provide a significant stride forward to this device’s functionality and more notably patient safety. Improving this device, with a focus on a better resolution to cuff rupture could be field-changing and have the ability to change the ETT design for decades to come.