Inflatable Frameless Mask Pneumatic Sealing

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Solution Overview

Problem

Conventional full-face masks for CPAP or NIV therapy are heavy, rigid, and uncomfortable due to their semi-rigid shells, which can be burdensome for long-term use and do not allow for effective monitoring of the user's airways.

Innovation Solution

A frameless, inflatable mask with a flexible shell that surrounds the nose and can be inflated with breathable gas to a higher pressure than ambient, featuring an optically transparent design and a nuchal strap for anchoring, along with an annular gasket for improved sealing and comfort, made from gas-impermeable plastic materials.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If a semi-rigid shell is used for the mask, then structural stability and seal are improved, but weight and user comfort deteriorate

Engineering Contradiction:
Improveseal qualityVSAvoidmask weight
Core Design Contradiction:
ReliabilityVSWeight of moving object

Solution Approach 1:

The mask shell transitions from a static semi-rigid structure to a dynamic inflatable structure. The shell starts in a deflated state and is inflated with breathable gas to achieve the desired shape and sealing pressure, allowing the structure to adapt dynamically to the user's face contours while maintaining light weight

Inventive Principle:
Principle #15Dynamics

Solution Approach 2:

The mask utilizes pneumatic inflation by introducing breathable gas into the shell to create the structural form and sealing pressure. The inflation system allows the shell to achieve adequate seal quality through controlled gas pressure while avoiding the need for heavy semi-rigid materials

Inventive Principle:
Principle #29Pneumatics and hydraulics

2Stability of the object's composition

If a semi-rigid shell is used for the mask, then structural stability is improved, but user comfort and adaptability deteriorate

Engineering Contradiction:
Improvestructural stabilityVSAvoidface contour adaptability
Core Design Contradiction:
Stability of the object's compositionVSAdaptability or versatility

Solution Approach 1:

The shell structure transitions from fixed to dynamic through inflation. When deflated, the shell is flexible and can be easily positioned; when inflated, it stabilizes into the required shape while adapting to different face contours through adjustable inflation pressure

Inventive Principle:
Principle #15Dynamics

Solution Approach 2:

The physical state of the shell is changed from deflated to inflated by varying the gas pressure parameter. This parameter change allows the shell to transition between flexible (for positioning) and stable (for sealing) states, while also adapting to different users by adjusting the inflation pressure level

Inventive Principle:
Principle #35Parameter changes

3Loss of information

If an optically transparent shell is used, then airway monitoring capability is improved, but structural strength deteriorates

Engineering Contradiction:
Improveairway visibilityVSAvoidshell strength
Core Design Contradiction:
Loss of informationVSStrength

Solution Approach 1:

The mask employs a thin, flexible, optically transparent shell that can be inflated to achieve the required structural strength. The strength is not derived from material thickness but from the internal gas pressure maintaining the shell's shape, allowing full optical transparency for airway monitoring while providing adequate structural support

Inventive Principle:
Principle #30Flexible shells and thin films

4Weight of moving object

If a flexible shell is used, then weight and comfort are improved, but sealing capability deteriorates

Engineering Contradiction:
Improvemask weightVSAvoidseal quality
Core Design Contradiction:
Weight of moving objectVSReliability

Solution Approach 1:

The flexible shell is inflated with breathable gas to generate internal pressure that forces the shell's peripheral edge against the user's face, creating an effective seal. The sealing force is provided pneumatically rather than through rigid structure or heavy weight

Inventive Principle:
Principle #29Pneumatics and hydraulics

Solution Approach 2:

The shell transitions from a deflated flexible state to an inflated state where the internal gas pressure dynamically adjusts the shell's shape and contact pressure with the face, achieving reliable sealing while maintaining the benefits of flexibility and light weight

Inventive Principle:
Principle #15Dynamics

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 mask provides a lightweight, comfortable, and economical solution that allows for complete monitoring of airways while reducing perceived weight and enhancing user comfort, with adjustable inflation pressure for optimal fit and functionality.

Implementation Method 1

the breathable gas introduced into the closed volume by the injection means inflates the shell from a deflated configuration of the shell to an inflated configuration of the shell, wherein in the inflated configuration the breathable gas inside the closed volume is at a higher pressure than ambient pressure

Methodology Applied
Scientific EffectGas pressure inflation: Pressure Increase

Implementation Method 2

joining a first shaped portion of a film of a flexible and inextensible plastic material to a second shaped portion of a film of a flexible and inextensible plastic material by radio frequency welding or heat sealing

Methodology Applied
Scientific EffectRadio frequency welding:

Implementation Method 3

joining a first shaped portion of a film of a flexible and inextensible plastic material to a second shaped portion of a film of a flexible and inextensible plastic material by radio frequency welding or heat sealing

Methodology Applied
Scientific EffectHeat sealing:

Data Source

PatentEP3558433B1Inflatable frameless mask for the ventilation of patients
Publication Date: 2021.09.01 INTERSURGICAL SPA
  • EP3558433B1 patent drawingFigure 1
  • EP3558433B1 patent drawingFigure 2~3
  • EP3558433B1 patent drawingFigure 4~5

AI summary

An inflatable frameless mask (10) for the ventilation of patients comprising: - a flexible and inextensible shell (20) provided with a peripheral edge (23) generally closed in a loop able to come in forced, fluid-tight contact with the face of the patient and to inscribe at least the nose of the patient, - means (40) for injecting a breathable gas positioned on the shell (20) for the injection of breathable gas inside a volume enclosed between the shell (20) and the face of the patient; - means (50) for the outflow of gases exhaled by the patient for the exit from the volume of the gases exhaled by the patient; - wherein the breathable gas introduced into the closed volume by the injection means (40) inflates the shell (20) from a deflated configuration of the shell (20) to an inflated configuration of the shell (20), wherein in the inflated configuration the breathable gas inside the closed volume is at a higher pressure than ambient pressure; and - wherein at least one portion of the flexible shell (20) is optically transparent.