Asymmetric Balloon Cuff Tracheostomy Tube for Secretion Management

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Solution Overview

Problem

Conventional tracheostomy tubes lack stability within the trachea, leading to movement and potential dislocation, which can cause inflammation and secretion accumulation, increasing the risk of ventilator-acquired pneumonia (VAP).

Innovation Solution

A balloon-cuffed tracheostomy tube design with a non-uniform inflatable balloon configuration, where the distal balloon portion is centered and the proximal balloon portion is off-center, providing enhanced anchorability without sealing the tracheal stoma, allowing secretions to exit through the stoma for removal.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If a conventional cuffed tracheostomy tube is used, then airway sealing is achieved, but tube stability and anchorage are poor leading to movement and dislocation

Engineering Contradiction:
Improveairway sealingVSAvoidtube stability
Core Design Contradiction:
ReliabilityVSStability of the object's composition

Solution Approach 1:

The balloon is divided into multiple segments: a distal balloon portion and a proximal balloon portion, each serving different functions. The distal portion provides sealing while the proximal portion provides anchorage, resolving the contradiction between sealing reliability and tube stability.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The proximal balloon portion is positioned off-center relative to the tube axis, creating an asymmetric configuration that enhances anchorage by engaging the tracheal wall more effectively. This asymmetric design improves tube stability without compromising the symmetric sealing function of the distal balloon portion.

Inventive Principle:
Principle #4Asymmetry

2Stability of the object's composition

If a balloon is inflated to control tube movement, then tube stability improves, but the tracheal stoma is sealed preventing secretion removal

Engineering Contradiction:
Improvetube stabilityVSAvoidsecretion accumulation
Core Design Contradiction:
Stability of the object's compositionVSObject-generated harmful factors

Solution Approach 1:

The balloon is segmented into distal and proximal portions with different functions. The distal portion seals the trachea below the stoma for stability, while the proximal portion is positioned to allow secretion egress through the stoma, preventing harmful secretion accumulation.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

Different portions of the balloon have different functional qualities: the distal portion provides sealing quality while the proximal portion provides anchorage quality with secretion egress capability. This local differentiation resolves the contradiction between stability and secretion removal.

Inventive Principle:
Principle #3Local quality

3Productivity

If the distal tip of the trach tube is positioned to reach the lower airways, then air delivery is effective, but the tip causes damage and inflammation to the posterior wall of the trachea

Engineering Contradiction:
Improveair delivery effectivenessVSAvoidtracheal wall damage
Core Design Contradiction:
ProductivityVSObject-affected harmful factors

Solution Approach 1:

The inflated proximal balloon portion acts as a counterweight or anchorage point that offsets the downward force and movement of the distal tip. This prevents the distal tip from rubbing against the posterior tracheal wall, eliminating damage while maintaining effective air delivery positioning.

Inventive Principle:
Principle #8Anti-weight (Counterweight)

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 design enhances tube stability, reduces the risk of dislocation, and facilitates secretion removal, thereby minimizing the risk of VAP while maintaining effective airway sealing below the stoma.

Implementation Method 1

an inflatable balloon component including a distal balloon portion substantially centered about and attached to the distal end portion of the tube and a proximal balloon portion attached to the bend region of the tube and positioned substantially off-center about the bend region below the proximal plane of the device

Methodology Applied
Scientific EffectInflation:

Implementation Method 2

Upon inflation, this configuration provides for expansion of the balloon around the distal end portion of the tube and the proximal end portion of the tube below the proximal plane of the device to seal the trachea below the tracheal stoma

Methodology Applied
Scientific EffectSealing:

Implementation Method 3

The balloon adheres to the internal lining of the trachea in its generally cross-sectional dimension in order to prevent air insufflated by the respirator into a patient from escaping to the environment

Methodology Applied
Scientific EffectAdhesion: Adhesive

Implementation Method 4

The balloon also aids in supporting the tube inside the trachea

Methodology Applied
Scientific EffectExpansion:

Implementation Method 5

a balloon designed so as to enhance the tube's anchorability

Methodology Applied
Scientific EffectAnchoring:

Data Source

PatentEP2192941B1Improved balloon cuff tracheostomy tube
Publication Date: 2017.08.02 AVENT INC
  • EP2192941B1 patent drawingFigure 1
  • EP2192941B1 patent drawingFigure 2
  • EP2192941B1 patent drawingFigure 3

AI summary

There is provided a balloon cuffed tracheostomy tube (160) with a balloon (175) designed so as to enhance the tube's anchorability without sealing the tracheal stoma (210). The tracheostomy tube device includes a conventional curved hollow tube. The distal (165) end of the tube is adapted for insertion through a tracheal stoma and into the tracheal lumen (200) of a patient's throat. The device further includes an inflatable balloon enveloping a portion of the tube. The balloon has a distal portion (180) substantially centered about and attached to the distal end portion of the tube, and a proximal portion (185) attached to the bend region of the tube and positioned substantially off-center relative to the proximal portion of the tube and about the bend region below the proximal plane of the device. Upon inflation, this configuration provides for expansion of the balloon around the distal end portion of the tube and the proximal end portion of the tube below the proximal plane of the device to seal the trachea below the tracheal stoma and to avoid sealing the trachea above the tracheal stoma. This configuration of the balloon should allow secretions to exit the stoma so that they do not accumulate and become a possible source of ventilator acquired pneumonia.