Adjustable Tracheostomy Tube Flange Locking Mechanism

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Solution Overview

Problem

Existing medico-surgical tubes, such as tracheostomy tubes, face challenges in securing a movable and lockable flange on obese patients where tissue thickness is significant, requiring a secure yet easy-to-operate locking mechanism, especially when the tube is wet and slippery.

Innovation Solution

A medico-surgical tube assembly featuring a manually-operable lever with a stem and elongate handle that rotates to tighten a C-shaped locking assembly with deformable rings around the tube, allowing the flange to be positioned and locked along the tube's length, with a design that includes a central plate and flexure sections for reduced pressure and ease of access.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Adaptability or versatility

If a fixed flange is used on the tube, then the structure is simple and secure, but it cannot be adjusted to suit patients with varying anatomy such as obese patients with thick tissue

Engineering Contradiction:
Improveadjustability of flange positionVSAvoidcomplexity of locking mechanism
Core Design Contradiction:
Adaptability or versatilityVSDevice complexity

Solution Approach 1:

The flange is made movable along the tube rather than fixed, allowing it to be positioned at different locations. The locking assembly includes a lever that can be operated to lock the flange at any desired position, transforming a static structure into a dynamic, adjustable one that adapts to varying patient anatomy

Inventive Principle:
Principle #15Dynamics

Solution Approach 2:

The locking assembly is designed to be easily operable by the user without requiring additional tools or complex procedures. The lever mechanism allows the user to simply pull the flange to the desired position and operate the lever to lock it, making the system self-servicing and user-friendly

Inventive Principle:
Principle #25Self-service

2Adaptability or versatility

If a movable and lockable flange is implemented, then adaptability to different patient anatomies is improved, but securing the flange securely becomes difficult especially when the tube is wet and slippery

Engineering Contradiction:
Improveadjustability of flange positionVSAvoidsecurity of flange fastening
Core Design Contradiction:
Adaptability or versatilityVSReliability

Solution Approach 1:

The locking assembly includes visual indicators that change appearance based on the locked state. When the lever is in the locked position, the visual indicator shows a specific configuration that is readily apparent to the user, providing immediate visual confirmation that the flange is securely locked without requiring tactile inspection

Inventive Principle:
Principle #32Color changes

Solution Approach 2:

The locking assembly uses curved or rounded surfaces in its design, particularly in the lever and clamping surfaces, which facilitate easy operation even when wet. The curved geometry allows for smooth movement and reduces friction, making it easier to operate the locking mechanism under wet conditions

Inventive Principle:
Principle #14Spheroidality (Curvature)

3Adaptability or versatility

If the flange is made movable and lockable, then it can be positioned ideally for obese patients, but the operation becomes more complex and difficult to secure easily

Engineering Contradiction:
Improveadjustability of flange positionVSAvoidease of locking and unlocking
Core Design Contradiction:
Adaptability or versatilityVSEase of operation

Solution Approach 1:

The locking assembly is divided into distinct functional components: a lever for operation, a stem for mechanical advantage, and clamping surfaces for securing the flange. This segmentation allows each component to be optimized for its specific function, making the overall operation simple and intuitive despite the added adjustability

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The lever acts as an intermediary mechanism between the user's manual operation and the locking action. By operating the lever, the user indirectly actuates the locking mechanism through mechanical advantage, making it easier to secure the flange compared to direct manipulation of the locking components

Inventive Principle:
Principle #24Intermediary (Mediator)

4Adaptability or versatility

If a locking assembly is added to make the flange movable and lockable, then adaptability is improved, but the device complexity increases

Engineering Contradiction:
Improveadjustability of flange positionVSAvoidcomplexity of locking assembly
Core Design Contradiction:
Adaptability or versatilityVSDevice complexity

Solution Approach 1:

The locking assembly is integrated with the flange structure rather than being a separate, additional component. The lever, stem, and clamping surfaces are combined into a single unified assembly that works together to provide locking functionality, reducing overall device complexity compared to having separate locking mechanisms

Inventive Principle:
Principle #5Merging (Combining)

Applied Scientific Principles

This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.

Function Achieved in This Case

The solution provides a secure and easy-to-use locking mechanism for the flange, ensuring a comfortable fit on patients with varying anatomy, reducing pressure on the neck and minimizing the risk of flange loss in skin folds, while being apparent when locked.

Implementation Method 1

The two parts of the locking assembly preferably have a plurality of deformable rings adapted to engage the outside surface of the tube

Methodology Applied
Scientific EffectElastic deformation: Elasticity

Implementation Method 2

The stem preferably has a threaded portion engaging a threaded aperture in one part of the locking assembly such that when the stem is rotated by moving the handle portion the two parts of the locking assembly are moved together

Methodology Applied
Scientific EffectThreaded fastening: Screw

Implementation Method 3

The two parts of the locking assembly are preferably of C shape and connected together by a living hinge

Methodology Applied
Scientific EffectFlexible hinge: Hinge

Implementation Method 4

the locking assembly includes a manually-operable lever having a stem and an elongate handle portion projecting outwardly of the stem to one side

Methodology Applied
Scientific EffectMechanical advantage: Lever

Data Source

PatentEP2035071B1Medico-surgical tube assemblies
Publication Date: 2013.09.04 SMITHS GROUP PLC
  • EP2035071B1 patent drawingFigure 1~2
  • EP2035071B1 patent drawingFigure 3~4
  • EP2035071B1 patent drawingFigure 5

AI summary

An adjustable flange for a tracheostomy tube has a locking assembly (25) with two C shape clamp arms (26) and (27) hinged together at one end (28). A lever (50) with a threaded stem (51) extends through the opposite end of one arm (27) and into a threaded aperture (32) in the other arm (26). When the handle (55) of the lever (50) is inclined out of the plane of the locking assembly (25) it can be slid freely along the tracheostomy tube (1) for positioning. The locking assembly (25) is locked in position by rotating the handle (55) down to lie in the plane of the locking assembly. The flange (20) has two wings (22) and (23) connected with a central plate (20) by webs (42) and (43) of reduced width so that the webs flex to allow the wings to be lifted readily.