Respiratory Mask Perimeter Seal and Support Frame

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Solution Overview

Problem

Current full-face masks for CPAP and NIV therapies face challenges in maintaining a tight pneumatic seal and comfort over extended periods, leading to potential respiratory risks and skin ulcers due to pressure issues.

Innovation Solution

A full-face mask design featuring a reusable support frame that uniformly distributes traction along the mask's perimeter edge, enhancing the seal between the mask and the patient's face, and an inflatable annular seal that maximizes hermetic sealing by compressing onto the face.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Stability of the object's composition

If a rigid or semi-rigid shell is used for the mask, then structural stability is improved, but comfort and risk of skin ulcers worsen due to concentrated pressure on the perimeter edge

Engineering Contradiction:
Improvestructural stabilityVSAvoidskin ulcers
Core Design Contradiction:
Stability of the object's compositionVSObject-affected harmful factors

Solution Approach 1:

The mask is divided into two main components: a rigid or semi-rigid shell for structural stability and a separate soft perimeter edge for comfort. This segmentation allows each part to fulfill its specific function without compromise - the shell maintains structural integrity while the soft edge distributes pressure to prevent skin ulcers.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

Different parts of the mask have different material properties optimized for their specific functions. The central shell area uses rigid or semi-rigid material for stability, while the perimeter edge uses soft, compliant material for comfort and pressure distribution. This local quality differentiation resolves the contradiction between structural requirements and comfort requirements.

Inventive Principle:
Principle #3Local quality

2Object-affected harmful factors

If a floppy shell is used for the mask, then comfort is improved, but pneumatic seal reliability worsens under high internal pressure

Engineering Contradiction:
ImprovecomfortVSAvoidpneumatic seal
Core Design Contradiction:
Object-affected harmful factorsVSReliability

Solution Approach 1:

The mask structure is segmented into a rigid or semi-rigid shell that maintains shape under pressure and a soft perimeter edge that provides comfort. This segmentation allows the shell to reliably maintain pneumatic seal under high internal pressure while the soft edge ensures patient comfort during extended wear.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The shell portion is made rigid or semi-rigid to maintain structural integrity and pneumatic seal under pressure, while the perimeter edge is made soft and compliant for comfort. This local quality differentiation resolves the contradiction between seal reliability and comfort.

Inventive Principle:
Principle #3Local quality

3Object-affected harmful factors

If the perimeter edge is made soft for comfort, then skin irritation is reduced, but seal effectiveness under high pressure worsens

Engineering Contradiction:
Improveskin irritationVSAvoidseal effectiveness
Core Design Contradiction:
Object-affected harmful factorsVSReliability

Solution Approach 1:

The perimeter edge is segmented from the main shell structure and given different material properties. The soft perimeter edge reduces skin irritation while the rigid or semi-rigid shell maintains seal effectiveness under high internal pressure. This segmentation allows both requirements to be satisfied simultaneously.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The perimeter edge uses soft material locally where it contacts the skin to reduce irritation, while the main shell body uses rigid or semi-rigid material to maintain seal effectiveness under pressure. This local quality approach resolves the contradiction between comfort and seal reliability.

Inventive Principle:
Principle #3Local quality

4Stability of the object's composition

If a neck strap is used to secure the mask, then mask positioning is improved, but uniform distribution of traction force worsens leading to concentrated pressure points

Engineering Contradiction:
Improvemask positioningVSAvoidconcentrated pressure
Core Design Contradiction:
Stability of the object's compositionVSObject-affected harmful factors

Solution Approach 1:

The traction force distribution is segmented from a single neck strap attachment to multiple attachment points around the perimeter edge. This segmentation allows the traction force to be distributed uniformly across the entire perimeter edge, preventing concentrated pressure points while maintaining secure mask positioning.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The attachment system transitions from a single-point (neck strap) attachment to a distributed multi-point attachment system around the perimeter edge. This dimensional change from 1D linear strap to 2D distributed perimeter attachment enables uniform force distribution and eliminates concentrated pressure points.

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

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, comfortable fit that maintains effective respiratory therapy by reducing gas leaks and minimizing skin irritation, ensuring consistent therapy effectiveness and patient safety.

Implementation Method 1

the annular seal is adapted to be compressed, in use, between the patient's face and the support frame

Methodology Applied
Scientific EffectCompression: Compression

Implementation Method 2

the support frame can be configured to be fitted onto the shell and exert a pressure on the perimeter edge of the shell against the patient's face

Methodology Applied
Scientific EffectPressure: Pressure Increase

Data Source

PatentEP3756716B1Mask for respiratory therapy for patients
Publication Date: 2023.03.22 INTERSURGICAL SPA
  • EP3756716B1 patent drawingFigure 1
  • EP3756716B1 patent drawingFigure 2~3
  • EP3756716B1 patent drawingFigure 4

AI summary

A mask (10) for non-invasive respiratory therapy for patients, which comprises: - a shell (20) provided with a closed loop perimeter edge (23) adapted to come into forced and fluid-tight contact with an area of the patient's face and inscribe at least one from between the nose and mouth of the patient; - intake means (40) of a breathable gas placed on the shell (20) for the intake of breathable gas into a volume contained between the shell (20) and the patient's face; - outflow means (50) of gases expired by the patient for the exit from the volume of the gases expired by the patient; and - an annular support frame (80) removably associated with the shell (20) in proximity to the perimeter edge (23) thereof.