Introducing Stylet with Gradient Rigidity for Smooth ETT Insertion

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Solution Overview

Problem

Conventional endotracheal intubation devices face challenges in positioning and smoothly passing the endotracheal tube through the larynx due to issues like the ETT becoming hung-up on laryngeal structures, and existing stylets do not adequately address these problems, often requiring re-shaping and re-attempts during procedures.

Innovation Solution

An improved introducing stylet with a distal end that extends longitudinally beyond the ETT, featuring a soft S-shape, obturating feature, Murphy eye plug, and oxygen source cap, which minimizes trauma and facilitates smooth passage by engaging the ETT to prevent movement and maintain air flow, while the obturating feature and bridges stabilize the ETT within the stylet.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of operation

If a rigid stylet is used to control ETT direction, then control and guidance of ETT tip is improved, but trauma risk to laryngeal structures increases

Engineering Contradiction:
Improvecontrol of ETT tipVSAvoidtrauma to laryngeal structures
Core Design Contradiction:
Ease of operationVSObject-affected harmful factors

Solution Approach 1:

The stylet changes its rigidity parameter along its length, with the proximal portion being rigid for control and the distal portion being flexible to reduce trauma. This gradient in rigidity allows the operator to maintain control while the flexible tip safely navigates laryngeal structures.

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The stylet is divided into distinct segments with different mechanical properties - a rigid proximal segment for operator control and a flexible distal segment for safe passage through the airway. This segmentation allows each portion to perform its specific function optimally.

Inventive Principle:
Principle #1Segmentation

2Adaptability or versatility

If manual shaping of stylet is performed, then customization of curvature is improved, but procedural time increases

Engineering Contradiction:
Improvecurvature customizationVSAvoidprocedural time
Core Design Contradiction:
Adaptability or versatilityVSLoss of time

Solution Approach 1:

The stylet is pre-formed with an optimal curvature that is determined through design rather than manual shaping during the procedure. This preliminary preparation eliminates the time-consuming manual bending step while maintaining the necessary adaptability for proper ETT guidance.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The stylet incorporates adjustable curvature parameters that can be modified within a range to accommodate different patient anatomies, eliminating the need for complete manual reshaping while still providing customization capability.

Inventive Principle:
Principle #35Parameter changes

3Ease of operation

If stylet extends beyond ETT distal end, then directional control is improved, but trauma risk increases

Engineering Contradiction:
Improvedirectional controlVSAvoidtrauma to vocal cords
Core Design Contradiction:
Ease of operationVSObject-affected harmful factors

Solution Approach 1:

The stylet exhibits a gradient in rigidity parameter, being rigid proximally for control and flexible distally to reduce trauma risk when extending beyond the ETT end.

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The distal portion of the stylet is constructed as a flexible element that can bend and conform to the airway anatomy, reducing the risk of trauma to vulnerable structures like the vocal cords while still providing directional guidance.

Inventive Principle:
Principle #30Flexible shells and thin films

4Productivity

If ETT passage is forced through larynx, then intubation speed is improved, but trauma and complications increase

Engineering Contradiction:
Improveintubation speedVSAvoidtrauma and complications
Core Design Contradiction:
ProductivityVSObject-affected harmful factors

Solution Approach 1:

The stylet's variable rigidity parameter allows it to be stiff enough for controlled advancement but flexible enough to bend around obstacles, enabling faster passage without excessive force that would cause trauma.

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The stylet dynamically adapts its flexibility along its length, with the distal portion able to bend and conform to the laryngeal anatomy in real-time, facilitating smooth passage through variable anatomical conditions without forcing that leads to complications.

Inventive Principle:
Principle #15Dynamics

Data Source

PatentEP3876812B1Introducing stylet
Publication Date: 2023.07.12 GARDNER GLENN P
  • EP3876812B1 patent drawingFigure 1
  • EP3876812B1 patent drawingFigure 2~7
  • EP3876812B1 patent drawingFigure 8~10

AI summary

An introducing stylet is configured for insertion into an endotracheal tube (ETT) and includes an elongated rod having a distal end and a proximal end, and a positioning feature formed on the rod and configured to engage the ETT to prevent both longitudinal and lateral movement of the introducing stylet relative to the ETT. A portion of the distal end of the rod that extends longitudinally outwardly of the ETT and defines a leading end.