Tracheal Introducer Sheath for Real-Time Tip Articulation
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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 difficulties in first-pass success and potential complications due to unwieldiness and lack of haptic control.
Innovation Solution
A tracheal introducer sheath (TIS) that allows for real-time articulation of the introducer tip up to 90 degrees, providing improved maneuverability and haptic control, and can be used with various introducer types, enhancing the proceduralist's ability to navigate the airway safely and efficiently.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If an introducer is used to assist endotracheal tube passage, then first-pass success rate improves, but the introducer's ability to maintain desired contour and angle deteriorates due to limited articulation capability
Solution Approach 1:
The introducer incorporates a dynamic articulation mechanism that allows the distal tip to articulate relative to the proximal shaft, enabling real-time angle adjustment (up to 90 degrees) during airway navigation. This dynamic capability resolves the contradiction by providing both reliable passage assistance and operational flexibility for maintaining desired contours.
Solution Approach 2:
The introducer is divided into distinct segments: a proximal shaft and a distal tip that can articulate independently. This segmentation allows the distal tip to be controlled separately for precise angular positioning while the proximal shaft maintains stability, thereby improving both first-pass success and articulation control.
2Ease of operation
If the introducer tip is made kinked and malleable to navigate the airway, then passage through cords improves, but control and haptic feedback deteriorate
Solution Approach 1:
The introducer separates navigation functions into distinct segments: a flexible, kinked distal tip for navigating airway obstacles and a stiffer proximal shaft for maintaining control and transmitting haptic feedback. This segmentation allows the tip to be highly maneuverable while the shaft remains controllable.
Solution Approach 2:
Different portions of the introducer have different mechanical properties: the distal tip is made soft and malleable for navigation, while the proximal shaft maintains appropriate stiffness for control. This local differentiation resolves the contradiction between navigation capability and control.
3Ease of operation
If manual molding of introducer tip is performed to aid navigation, then angular control improves, but time consumption and procedural complexity increase
Solution Approach 1:
The introducer features a dynamically articulating tip that can be controlled in real-time during the procedure, eliminating the need for static pre-molding. The operator can adjust the tip angle on-demand as needed for navigation, significantly reducing preparation time while maintaining angular control capability.
Solution Approach 2:
The articulation mechanism acts as an intermediary between the operator's control inputs and the distal tip positioning, enabling precise angular control without manual molding. This mechanical mediation provides responsive control while eliminating time-consuming preparation steps.
Data Source
AI summary
A tracheal introducer sheath device (TIS) device is disclosed for guiding the insertion of a tracheal introducer. Tracheal introducer sheath device has a hollowed tube of flexible material that provides a sheath channel for a tracheal introducer. Tracheal introducer sheath device has a proximal end and a distal end. Tracheal introducer is guided via the sheath channel from the proximal end in a controller manner to a glottic opening of a person's airway. Sheath channel in the tracheal introducer sheath device is manually moldable to articulate different angles, wherein the different angles supports the movement of the tracheal introducer deeper into a person's airway.