Tracheostomy Spirometry Device with Ellipsoidal Anchoring Flange

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Solution Overview

Problem

Current devices for performing spirometry in patients with tracheostomy fail to ensure a reliable and easy procedure due to instability and non-hermetic connections, altering airflow and fluid-dynamic resistance.

Innovation Solution

A 3D-printed, hollow cylindrical device with a countersink for a mouthpiece and an ellipsoidal anchoring flange for secure adhesion to the tracheostoma, ensuring a hermetic and stable connection, made from biocompatible polymeric materials for reusability and compatibility with disinfectants.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Object-affected harmful factors

If a filter is included in the device, then bacterial protection is improved, but fluid-dynamic resistance of air flow is worsened

Engineering Contradiction:
Improvebacterial protectionVSAvoidfluid-dynamic resistance
Core Design Contradiction:
Object-affected harmful factorsVSObject-generated harmful factors

Solution Approach 1:

The patent removes the filter component from the device structure. The specification explicitly states 'without filters' and explains that filters alter fluid-dynamic resistance and complicate the device. The bacterial protection function is achieved through the hermetic seal and closed system design rather than through a filter component.

Inventive Principle:
Principle #2Taking out (Extraction)

Solution Approach 2:

The patent employs disposable mouthpieces and exchanger components that are discarded after use, eliminating the need for reusable filters that would accumulate resistance. The disposable nature of these components simplifies the system while maintaining hygiene through proper disposal rather than filtration.

Inventive Principle:
Principle #27Cheap short-living objects (Disposable)

2Ease of manufacture

If connection elements are simplified, then ease of manufacture is improved, but connection stability and hermetic seal are worsened

Engineering Contradiction:
Improveease of manufactureVSAvoidconnection stability
Core Design Contradiction:
Ease of manufactureVSReliability

Solution Approach 1:

The device is divided into separate modular components: a reusable body, disposable mouthpieces, and exchanger components. Each segment can be manufactured independently using simple processes, while the modular design ensures stable connections through standardized coupling mechanisms that maintain hermetic seals.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The patent employs flexible sealing elements and thin-film membranes at connection interfaces to ensure hermetic seals. These flexible components adapt to slight dimensional variations and maintain reliable connections without requiring complex rigid fastening mechanisms.

Inventive Principle:
Principle #30Flexible shells and thin films

3Device complexity

If the device structure is simplified, then device complexity is improved, but adaptability to different filters and configurations is worsened

Engineering Contradiction:
Improvedevice complexityVSAvoidadaptability to filters
Core Design Contradiction:
Device complexityVSAdaptability or versatility

Solution Approach 1:

The device body is designed with universal coupling mechanisms that can accommodate various mouthpiece types and exchanger configurations. The standardized interfaces allow the same reusable body to work with different disposable components, providing versatility without increasing structural complexity.

Inventive Principle:
Principle #6Universality (Multi-functionality)

Solution Approach 2:

The device incorporates adjustable and reconfigurable elements that allow adaptation to different patient needs and test configurations. The dynamic design enables the same basic structure to accommodate various mouthpiece positions and exchanger types through simple reconfiguration rather than multiple specialized devices.

Inventive Principle:
Principle #15Dynamics

Data Source

PatentEP4491109A1Device for performing spirometry in patients with tracheostomy
Publication Date: 2025.01.15 UNIV DEGLI STUDI MAGNA GRAECIA DI CATANZARO
  • EP4491109A1 patent drawingFigure 1
  • EP4491109A1 patent drawingFigure 2
  • EP4491109A1 patent drawingFigure 3

AI summary

A device (100) for performing spirometry in patients with tracheostomy comprising a hollow cylindrical body (101), having a first end (101a) provided with a countersink (101aa) for hermetic connection to a disposable spirometer filter, and a second end (101b) provided with a protrusion (101bb) configured to adhere to a connector that adheres to the tracheostoma. Said second end (101b) has a substantially ellipsoidal shaped flange (101bc), suitable for anchoring a cannula-holding collar. Said flange (101bc) comprises two through holes (101c), symmetrically located on opposite sides of the flange (101bc).