Tracheostomy HME Device With Nested Heat Exchange Element

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Solution Overview

Problem

Conventional HME devices for tracheostomy tubes are bulky, conspicuous, prone to displacement, cause discomfort due to twisting motion, and introduce additional deadspace, which can lead to patient trauma and increased waste.

Innovation Solution

The HME device is designed with the HME element extending inside the tracheostomy tube connector, featuring a tapered inner surface and an annular recess, allowing for a clip-fit removal without twisting, reducing bulkiness and deadspace, and enabling easy replacement.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of operation

If the HME element is contained in a housing that projects outwardly from the tracheostomy tube, then the HME element is accessible for replacement, but the device becomes bulky and conspicuous increasing the risk of displacement and patient discomfort

Engineering Contradiction:
ImproveAccessibility of HME element for replacementVSAvoidBulkiness of HME device
Core Design Contradiction:
Ease of operationVSVolume of moving object

Solution Approach 1:

The HME element is nested within the internal lumen of the tracheostomy tube connector, with the external housing containing only the machine end portion. This nesting arrangement allows the HME element to be accessible for replacement while minimizing the overall device volume and eliminating the protruding structure that causes bulkiness and displacement risks.

Inventive Principle:
Principle #7Nested doll (Nesting)

2Volume of moving object

If the HME element is positioned to extend inside the connector, then the device bulk is reduced and deadspace is minimized, but the connector geometry becomes more complex

Engineering Contradiction:
ImproveBulkiness of HME deviceVSAvoidGeometry of connector
Core Design Contradiction:
Volume of moving objectVSDevice complexity

Solution Approach 1:

The connector is segmented into distinct functional zones: an internal lumen portion that receives the HME element, an external housing portion that contains the machine end, and a transition zone with annular recesses. This segmentation allows the complex geometry to be organized into manageable sections, each serving a specific function, thereby reducing overall device bulk while maintaining manageable geometric complexity.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The design utilizes radial and axial dimensional variations, with annular recesses positioned at specific radial distances from the connector axis. The HME element extends axially within the connector while the housing provides radial containment. This multi-dimensional arrangement minimizes bulk and deadspace without requiring overly complex single-dimension geometries.

Inventive Principle:
Principle #17Another dimension (Dimensionality change)

3Reliability

If a tapered slip fit connection is used between HME and connector, then the connection is secure, but the HME must be twisted during installation and removal causing discomfort

Engineering Contradiction:
ImproveSecurity of connectionVSAvoidTwisting motion during installation
Core Design Contradiction:
ReliabilityVSEase of operation

Solution Approach 1:

The connection interface is segmented into a reusable external housing portion and a replaceable internal HME element portion. The housing includes a tapered slip fit connection to the connector that provides secure attachment, while the HME element can be removed from the housing without twisting. This segmentation allows the secure connection to be maintained while eliminating the twisting motion that causes patient discomfort.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The connection system transitions from a rigid twist-fit mechanism to a dynamic system where the housing provides a stable, twist-free connection point. The tapered slip fit allows for easy insertion and removal of the HME element from the housing without requiring twisting of the entire assembly, thereby maintaining connection security while improving ease of operation.

Inventive Principle:
Principle #15Dynamics

4Ease of operation

If the HME element is made removable from the housing, then replacement is easier and waste is reduced, but the housing structure becomes more complex

Engineering Contradiction:
ImproveEase of replacementVSAvoidStructure of housing
Core Design Contradiction:
Ease of operationVSDevice complexity

Solution Approach 1:

The HME device is segmented into a reusable external housing portion and a replaceable internal HME element portion. The housing includes a tapered slip fit connection to the connector and annular recesses for positioning, while the HME element can be easily removed from the housing without complex mechanisms. This segmentation enables easy replacement and waste reduction while keeping the housing structure relatively simple.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The HME element is extracted as a separate, removable component from the housing structure. The housing is designed with simple annular recesses and a tapered slip fit connection that allow the HME element to be easily removed and replaced without complex mechanisms. This extraction approach facilitates easy replacement and waste reduction while minimizing the added complexity to the housing structure.

Inventive Principle:
Principle #2Taking out (Extraction)

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 minimizes patient discomfort, reduces the risk of displacement, decreases deadspace, and lowers environmental waste by allowing easy and twist-free replacement of the HME element, while maintaining effective heat and moisture exchange.

Implementation Method 1

When the patient exhales, gas passes through the exchange element and gives up a major part of its heat and moisture to the element. When the patient inhales, gas passes through the exchange element in the opposite direction and takes up a major part of the heat and moisture in the exchange element

Methodology Applied
Scientific EffectHeat exchange: Heat Exchanger

Implementation Method 2

The HME device is configured such that a major part of the length of the HME element is arranged to extend inside the cooperating connector on the tube, that the outer housing of the HME device has a tapered inner surface suitable to fit on the male tapered outside of the cooperating connector

Methodology Applied
Scientific EffectFriction: Friction

Implementation Method 3

the outside of the HME element is spaced from the inner surface of the outer housing at least along its patient end such as to define an annular recess at the patient end of the device in which at least the machine end of the cooperating connector can be received

Methodology Applied
Scientific EffectPhysical containment: Physical Containment

Data Source

PatentEP4346968B1Heat and moisture exchange device
Publication Date: 2025.09.17 ICU MEDICAL INTERNATIONAL LTD
  • EP4346968B1 patent drawingFigure 1
  • EP4346968B1 patent drawingFigure 2
  • EP4346968B1 patent drawingFigure 3

AI summary

An HME device (2) for a tracheal tube (1) has an outer housing (21) with an HME element (20) spaced from the housing at its patient end by an annular recess (40). The HME element (20) is retained with the outer housing (21) by a clip fitting (29) and (30). The inside surface (26) of the housing (21) is tapered to fit on the outside of a connector (13) on the tube (1) so that the connector extends in the recess (40). The HME element (20) extends internally of the connector (13) and can be removed from the tube (1) by releasing the clip fitting with the outer housing (21).