Stylet With Pivotable Tip For Intubation

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Solution Overview

Problem

Current intubation methods face challenges in accurately visualizing and placing endotracheal tubes, particularly in patients with restricted neck flexibility or obesity, due to limited visualization and the need for precise tube shaping, which can lead to delays and incorrect placements.

Innovation Solution

A stylet with a pivotable tip and controlled actuator mechanism that allows ±90° movement, combined with an image acquisition device and a preforming rod, enables precise adjustment and visualization of the tube's placement, facilitating accurate intubation by providing a wide range of motion and minimizing obstruction.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Illumination intensity

If a video laryngoscope is used to facilitate intubation in patients with restricted neck flexibility or obesity, then visualization of the airway is improved, but the distal end of the blade partially obstructs the field of view and the ET tube may obstruct the view of the vocal cords and trachea

Engineering Contradiction:
Improvevisualization capabilityVSAvoidobstruction of field of view
Core Design Contradiction:
Illumination intensityVSObject-generated harmful factors

Solution Approach 1:

The device is divided into functionally separate components: a laryngoscope blade for visualization and a stylet for tube manipulation. The stylet can be independently shaped and positioned to guide the ET tube without interfering with the optical path, as it operates through the tube lumen rather than in the visual field.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The stylet acts as an intermediary tool that transfers the shaping control to the ET tube indirectly. By pre-shaping the stylet to match the desired tube configuration, the tube can be guided through the airway without requiring direct manipulation that would obstruct the view.

Inventive Principle:
Principle #24Intermediary (Mediator)

2Ease of operation

If the ET tube is made from semi-rigid polymer with a gentle curve to align with airways, then the tube is flexible and comfortable, but it cannot retain a specific shape with sharper bends needed to aid insertion through vocal cords into trachea

Engineering Contradiction:
Improveflexibility and comfortVSAvoidability to retain sharp bends
Core Design Contradiction:
Ease of operationVSShape

Solution Approach 1:

The stylet is pre-shaped to the specific configuration needed for the patient's anatomy before intubation begins. This preliminary shaping allows the ET tube to be inserted with the correct sharp bends already in place, eliminating the need for intra-procedural manipulation that would obstruct the view or delay the procedure.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The stylet provides temporary rigid structural support to the flexible ET tube during insertion, allowing it to hold sharp bends. Once the tube is positioned, the stylet is removed and the tube returns to its natural flexible state for patient comfort.

Inventive Principle:
Principle #15Dynamics

3Shape

If a stylet is inserted into the ET tube to hold it in a specific shape to facilitate intubation, then the tube can be shaped to match patient anatomy, but setting the shape of the stylet before intubation can lead to delays where the set shape turns out to be not quite right for the patient's anatomy

Engineering Contradiction:
Improvecustomization to patient anatomyVSAvoiddelays during intubation procedure
Core Design Contradiction:
ShapeVSLoss of time

Solution Approach 1:

The stylet incorporates a dynamic control mechanism that allows real-time adjustment of its shape during the intubation procedure. The control wires extend to the proximal end where they can be manipulated to deflect the distal end of the stylet, enabling the clinician to adapt the shape to match the patient's specific anatomy without delay.

Inventive Principle:
Principle #15Dynamics

Solution Approach 2:

The system provides visual feedback through the video laryngoscope to show how the tube is positioned in real-time, allowing the operator to adjust the stylet shape based on observed feedback and achieve correct placement more quickly.

Inventive Principle:
Principle #23Feedback

4Measurement precision

If direct visualisation of the ET tube passing through the vocal cords into the trachea is used to determine correct placement, then placement accuracy is improved, but this method is not always possible depending on patient anatomy such as restricted neck flexibility or obesity

Engineering Contradiction:
Improveplacement accuracyVSAvoidapplicability to different patient anatomies
Core Design Contradiction:
Measurement precisionVSAdaptability or versatility

Solution Approach 1:

The stylet's controllable deflection mechanism allows it to adapt to different anatomical configurations by adjusting the shape in real-time based on the patient's specific airway geometry, maintaining visualization capability across diverse patient populations.

Inventive Principle:
Principle #15Dynamics

Solution Approach 2:

The system changes the physical parameters of the stylet (deflection angle, curvature) to match different patient anatomies, allowing direct visualization to be achieved regardless of neck flexibility or body type.

Inventive Principle:
Principle #35Parameter changes

Data Source

PatentEP3628015B1Stylet and intubation kit
Publication Date: 2024.07.03 FLEXICARE GRP LTD
  • EP3628015B1 patent drawingFigure 1(a)~1(b)
  • EP3628015B1 patent drawingFigure 2(a)~2(b)
  • EP3628015B1 patent drawingFigure 3

AI summary

A stylet is disclosed for insertion into an endotracheal tube for guiding the tube during intubation. The stylet has a body (3) with a pivotable tip portion (5) at its distal end which is movable in either of two opposing directions away from the axis of the stylet. The tip portion (5) may carry an image acquisition device for video imaging. A control mechanism for controlling the pivot angle of the pivotable tip has a hand-operated actuator (7) at the proximal end of the stylet and flexible control wires (23) extending down the stylet to connect the actuator to the pivotable tip portion (5). Also disclosed is an endotracheal tube (100) usable with the stylet and having a bending portion (103), defined by a concertina or thinned portion, at its distal end to facilitate bending of its tip portion (104) by the stylet tip portion (5).