Tracheal Cannula Flexible Flange Insertion Aid

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Solution Overview

Problem

Existing voice restoration devices for tracheostoma insertion often cause irritation, immune reactions, and coughing due to liquid-soluble substances or incomplete dissolution, making it difficult to achieve optimal airflow and correct positioning.

Innovation Solution

A device with flexible wings held by an insertion aid, which unfolds for optimal positioning, featuring a cylindrical body, a flexible flange with air circulation spaces, and a pen-shaped introducer with a spherical tip to facilitate smooth insertion and adjustment, made from flexible silicone with a stopper for adjustable depth.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of operation

If liquid-soluble substances (gelatine capsules) are used for insertion aid, then the device can be inserted into the tracheostoma, but irritation or immune reactions occur in the patient and the capsules do not dissolve completely

Engineering Contradiction:
Improveinsertion easeVSAvoidirritation and immune reactions
Core Design Contradiction:
Ease of operationVSObject-affected harmful factors

Solution Approach 1:

The harmful gelatine capsule is extracted and replaced with a safe alternative. The patent removes the dissolution mechanism that caused irritation and substitutes it with a mechanical release system using a magnet and detachable cap, eliminating the harmful substance while preserving the insertion aid function.

Inventive Principle:
Principle #2Taking out (Extraction)

Solution Approach 2:

The material property of the insertion aid is changed from liquid-soluble (gelatine) to magnetically responsive. Instead of relying on chemical dissolution, the new system uses magnetic field interaction to control the release mechanism, fundamentally changing the operational parameter from chemical to physical.

Inventive Principle:
Principle #35Parameter changes

2Reliability

If a large retaining collar is used to improve prosthesis retention, then the prosthesis is protected against coughing up, but it becomes more difficult to insert and traumatizes the surrounding tissue

Engineering Contradiction:
Improveprosthesis retentionVSAvoidtissue trauma
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The retaining collar is transformed from a static large structure to a dynamic collapsible structure. During insertion, the collar is compressed to a small diameter to minimize tissue trauma, and after positioning, it expands to provide adequate retention, thus resolving the contradiction between size for retention and size for insertion.

Inventive Principle:
Principle #15Dynamics

Solution Approach 2:

The retaining collar is designed to nest within itself during insertion. The collar collapses concentrically like nested dolls, allowing the large retention structure to be packaged in a compact form that can pass through the tracheostoma without causing excessive tissue damage.

Inventive Principle:
Principle #7Nested doll (Nesting)

3Ease of operation

If the flange is held in folded orientation during insertion, then the device can be inserted smoothly, but the flange must be unfolded to achieve optimal airflow orientation

Engineering Contradiction:
Improveinsertion smoothnessVSAvoidpositioning complexity
Core Design Contradiction:
Ease of operationVSDevice complexity

Solution Approach 1:

A magnet serves as an intermediary between the user and the flange orientation mechanism. The magnet externally controls the orientation of the flange by interacting with the magnetically responsive insertion aid, eliminating the need for manual manipulation of the flange itself and simplifying the positioning process.

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The mechanical system of manually unfolding and positioning the flange is replaced with a magnetic field-based system. The magnetically responsive insertion aid allows remote control of the flange orientation through magnetic attraction, substituting direct mechanical manipulation with field-based control.

Inventive Principle:
Principle #28Mechanics substitution (Replace mechanical system)

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

Enables correct positioning for optimal airflow without irritation or immune reactions, reducing the risk of coughing and improving insertion ease and safety.

Implementation Method 1

a flexible flange (2) provided on an outer surface of the device body (1) and having a direction of use in which it extends substantially outwardly from the outer surface of the device body (1) and having an insertion direction in which it is resiliently folded toward the longitudinal axis of the device body (1)

Methodology Applied
Scientific EffectElastic deformation: Elasticity

Implementation Method 2

There are air circulation spaces (221) between the wings (21) of the flange (2)

Methodology Applied
Scientific EffectFluid flow through porous structure: Porosity

Data Source

PatentEP2632523B1Device in the form of a tracheal cannula or a prosthesis for restoring the voice, to be inserted in a tracheostoma
Publication Date: 2017.07.12 PRIMED HALBERSTADT MEDIZINTECHN
  • EP2632523B1 patent drawingFigure 1

AI summary

The aim of the invention is to provide a device for insertion into a hole between the trachea and the oesophagus, which allows a correct positioning of the device in the patient in the direction of use and under an optimal air stream, without provoking irritations or immune reactions from behalf of the patient and without the risk of being ejected by the patient. Said aim is achieved by a device which comprises a cylindrical device body (1) having a longitudinal axis, a flexible flange (2) which is provided on an outer surface of the device body (1) and has a direction of use in which it extends essentially from the outer surface of the device body (1) to the outside and has a direction of use in which it is folded flexibly in the direction towards the longitudinal axis of the device body (1), as well as a pin-shaped insertion aid (3) having a means (31) for retaining the flange (2) in its flexibly folded orientation, wherein the flange (2) is formed by at least two wings (21) which have a recess (23) in the wing tip region (22), in which the means (31) is removably introduced and that the wings (21) have a shape memory that orients the wings (21) away from the longitudinal axis of the device body (1).