Cuffed Inner Cannula and Flexible Outer Cannula Trachesotomy Device: Ensuring a Stable Airway

Abstract

Tracheostomy tubes (TTs) are used to provide a direct airway to a patient’s trachea when natural respiration is no longer possible. A TT generally includes an elongate outer cannula as well as a smaller inner cannula formed so as to have a gradual curve to facilitate insertion into a patient’s trachea. In order seal the airway around the tube, a conventional TT generally has an inflatable cuff attached to the perimeter of the outer cannula. When inflated, the cuff seals the airway around the cannula, thereby, requiring air to pass through only the cannula. In order to retain the distal end of the device in its operative position, the TT generally includes a neck plate or other fixation device, which is attached to the proximal end of the outer cannula. There are many potential drawbacks with current TTs, which can range in effect from minor irritation to death. Varying sizes of individuals and differences in anatomical dimensions leads to discomfort from TTs that fit poorly. The rigid ends of the outer cannula often put pressure on the walls of the trachea, which can cause irritation and ulceration. Cuffed inner cannulas are required to be replaced with uncuffed inner cannulas as soon as possible, after placement, to avoid pressure necrosis and allow for vocalization. The process of switching TTs may also be very hazardous, especially when treating obese patients. The stoma can easily be lost among layers of fat and skin, as well as the trachea, which all move independently of one another. Losing the stoma may cause suffocation and possibly death. Our novel device is a TT for use with a neck plate having an aperture. The TT comprises an elongate outer cannula having a lumen and configured to extend through the aperture. An elongate inner cannula having a lumen and an inflatable cuff and configured to extend through the lumen of the outer cannula such that the cuff extends beyond a distal end of the outer cannula and an interlocking mechanism configured to releasably secure a proximal end of the inner cannula to a proximal end of the outer cannula. This superior TT has the potential for wide application with a special emphasis on application within the obese population. Such patients experience the most difficulty with current devices. There is no single device in the market today that packages the numerous features of this particular design.