Articulating Tracheal Introducer Sheath for Precise Intubation Angles
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Solution Overview
Problem
Existing introducers face limitations in maintaining desired contours and angles during intubation, particularly when navigating around the epiglottis, leading to difficulty in visualizing the vocal cords and increasing the risk of complications due to excessive time and force applied externally.
Innovation Solution
A tracheal introducer sheath (TIS) that allows for real-time articulation of the introducer tip between 10 and 90 degrees, providing improved haptic control and maneuverability, and can accommodate various introducer types based on clinical needs, while being stiffer to reduce wobbling and improve safety.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If a kinked or angled introduces tip is used to navigate around the epiglottis, then the introducer can pass through the glottic opening, but the introduces tip becomes extremely limited in taking steep angles and requires external force vectors that are difficult to control
Solution Approach 1:
The patent places an articulating mechanism inside a sheath structure, where the sheath contains the articulation components (wires, channels, and articulation component) while allowing the introducer to be passed through the sheath. This nested arrangement enables complex angular control to be housed within a simple external structure, resolving the contradiction between ease of operation and device complexity.
Solution Approach 2:
The patent implements a dynamic articulating mechanism that allows the introduces tip to be adjusted between 10 and 90 degrees during the procedure. The articulation component can be positioned at different angles along the introduces shaft, enabling real-time angular adjustment without requiring multiple separate devices or complex external control systems.
2Ease of operation
If manual molding of a kink is performed prior to introduction, then the introduces tip can be shaped to navigate the airway, but the angle cannot be manipulated after placement and requires corrective actions that have limited utility
Solution Approach 1:
The patent enables dynamic angular adjustment of the introduces tip during the intubation procedure through the articulating mechanism. The articulation component can be repositioned along the introduces shaft to achieve desired angles between 10 and 90 degrees, eliminating the need for time-consuming corrective actions after initial placement.
Solution Approach 2:
The patent incorporates haptic feedback through the articulation component, allowing the operator to feel the angular position and manipulation resistance through the sheath. This feedback mechanism enables real-time angular adjustment without requiring visual or temporal confirmation of each corrective action, reducing procedural time.
3Adaptability or versatility
If a flexible introduces tip is used to navigate around the epiglottis, then the introduces can pass through the cords, but the introduces tip cannot maintain desired contour and takes a sharp angle that is difficult to control
Solution Approach 1:
The patent implements a dynamic articulation system that allows the introduces tip to be adjusted between 10 and 90 degrees during the procedure. The articulation component can be positioned at different angles along the introduces shaft, enabling real-time angular adjustment without requiring multiple separate devices or complex external control systems.
Solution Approach 2:
The patent changes the physical state of the introduces tip from a fixed kinked configuration to a dynamically adjustable articulation mechanism. The articulation component can be positioned at different angles along the introduces shaft, enabling real-time angular adjustment without requiring multiple separate devices or complex external control systems.
4Force
If external force vectors are applied to control the introduces, then the introduces can be pushed through the airway, but the force control is difficult and may cause complications from excessive force
Solution Approach 1:
The patent uses the sheath as an intermediary structure that guides and constrains the introduces during passage through the airway. The sheath provides a stable channel that reduces the need for external force vectors, allowing the introduces to be propelled with more precision and less risk of complications from excessive force.
Solution Approach 2:
The patent employs a flexible sheath structure that can conform to the airway anatomy while providing sufficient structural support to control the introduces. The sheath's flexibility allows it to navigate the airway curves without requiring excessive external force, while its structural integrity maintains control precision during propulsion.
Data Source
AI summary
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 academic hospitals), which is often cost prohibitive for many rural and community hospitals to stock. As such, the TIS may improve access of lower socioeconomic classes to important technologies in the management of respiratory failure.