TRACHEAL INTRODUCER SHEATH AND SIMPLIFIED TRACHEAL INTRODUCER SHEATH

Abstract

According to the CDC, the same month (March, 2020) they declared COVD-19 a pandemic, nearly 25% of confirmed COVID-19 hospitalized patients required intubation, or ventilator use. More recently, in the US, during the summer of 2021, child intubations more than quadrupled, when the Delta variant predominated. As Omicron and additional COVID-19 variants continue to arise globally, there will be an increasing number of sudden spikes in critical illness and respiratory failure. Preparedness with efficacious airway tools that optimize success rate of intubations is critical. Without the proper tools, intubation procedures take excessive time, and can fail entirely, causing diminished central nervous system oxygenation and potentially permanent neurologic sequelae. Airway adjuncts such as the Tracheal Introducer Sheath (TIS) and Simplified Tracheal Introducer Sheath (STIS) hold immense potential to improve chances of successful intubations. The TIS is a STIS with an added articulating mechanism, but otherwise is a similar device. For the purposes of further explanation, the TIS refers to both TIS and STIS unless otherwise specified. TIS is an adjunct medical device for control and guidance of any form of tracheal introducer device through the glottic opening of a patient's airway. This facilitates endotracheal intubation by passage of the endotracheal tube. An airway introducer is placed within and controlled by the TIS, a mechanically specialized sheath, open at both ends, and covering the distal end of the introducer (where control is most relevant). The TIS acts as a relatively stiff channel, or tunnel, for the introducer to be directed through for smooth travel along courses of varied angles. The proceduralist is able to apply curvature in real-time to the TIS-introducer assemblage based on patient anatomy and other clinical factors. Without the TIS as a channel, an introducer alone can be bent at its tip, but it is limited in its ability to move along that axis as it is being proximally controlled, outside of the patient. The mechanistic basis for the sheath's guidance capability is based on composition, including, but not limited to, a hollowed shaft of polytetrafluoroethylene (PTFE), with a specific ID/OD (internal diameter/outer diameter) ratio, such that there is sufficient stiffness for the sheath to act as a guide within which the introducer can travel, whilst maintaining appropriate elasticity for malleable control. The TIS confers additional introducer controllability by minimizing introducer wobble, as introducers can consist of relatively long shaft-like devices, often nearly 60 cm. Introducer guidance by a TIS, but not the simplified version (STIS) includes a distal articulating tip mechanism, angled as needed while in the tracheal space of a patient, and controlled outside of the patient by moving the proximal sheath through a pull sheath mechanism. To recap, the Simplified Tracheal Introducer Sheath (STIS) lacks this articulating mechanism, but otherwise is a similar device. Rotatory control in the case of both the TIS and STIS is achieved by rotating the introducer which sits outside the proximal end of the sheath. A major additional benefit of utilizing a sheath with an introducer is selection of an introducer for placement into a sheath on a case-by-case basis. For example, a smaller, softer tipped introducer could be utilized with a TIS in cases where airway friability or injury is of particular concern; i.e. a mass with high vascularity and bleeding potential. In another example an introducer with a central canal for oxygenation can be utilized with a TIS when the decision is made to oxygenate through the introducer prior to placement of the endotracheal tube. Finally, the TIS, with its integration of an articulating mechanism utilizing a pull sheath is without costly electrical components and thus serves as a cost-effective alternative to fiberoptic intubation with a bronchoscope (often utilized among top ...

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