Safer Endotracheal Tube Cuff Pressure Regulation System
Background: The means to regulate endotracheal tube cuff pressure have been proposed in order to decrease the incidence of post-intubation complications caused by cuffed endotracheal tube. The regulation of endotracheal tube cuff pressure in prior art is achieved via a complex external pressure regulating device, which is characterized by inflating the cuff to the desired maximum pressure level during inspiration and deflating the cuff to the desired minimum pressure level during expiration.
The problem, which is the compression pressure on the interior surface of trachea caused by the constant non-regulated endotracheal tube cuff pressure, has not been solved yet. Regulated cuff pressure via an external complex pressure regulating device in prior art has never been fashioned clinically because of its complicated design and proneness to error.
Therefore, a clinically practical and cost-effective means to regulate endotracheal tube cuff pressure during inspiration-expiration cycle will decrease post-intubation discomfort and complications. A much improved short-term and long-term outcome after endotracheal intubation is foreseeable if the above mentioned problem can be solved.
Technology: Anesthesiologists at the University of California, Irvine have invented an endotracheal tube cuff pressure regulating system that can synchronize and equalize the pressures inside of an endotracheal tube cuff and breathing circuit. During the inspiration phase of positive pressure ventilation when breathing circuit pressure rises, the endotracheal tube cuff is inflated via the invented system until an equalized pressure between circuit and cuff is achieved. In contrast, during the expiration phase of positive pressure ventilation when the breathing circuit pressure declines, the endotracheal tube cuff is deflated via the invented system until an equalized pressure between circuit and cuff is again achieved.
The result of this new system is to deliver the desired tidal volume during inspiration when endotracheal tube cuff is inflated and to relieve the compression pressure on the interior surface of trachea during expiration when endotracheal tube cuff is deflated. The vantage of this invention is two folds: (1) guaranteed tidal volume during inspiration so that minute ventilation is not in jeopardy; (2) relieved compression on the trachea during expiration so that post-intubation complications will be minimized.
Application: The invention presented here is intended to be used in any situations where endotracheal intubation is planned. This new method and apparatus allows for pressure equalization and synchronization between endotracheal tube cuff and breathing circuit to be achieved. The pressure regulating system in new apparatus is clinically practical, cost-effective, and error immune in comparison to the prior art because it does not depend on complicated external pressure regulating device. In addition, in situations where overwhelming aspiration risks exist, the endotracheal tube based on the invention can be easily converted into the conventional one in that a constant positive pressure inside of the endotracheal tube cuff can be maintained in order to better protect the airway. This invention is qualified for FDA exemption based on 510(k) Premarket Notification Database (Regulation Number 868.5730).
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