Corrugated Sealing Flap for Patient Interface Devices
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Solution Overview
Problem
Conventional patient interface devices for non-invasive ventilation and pressure support therapies face issues with sealing problems, pressure points, and red marks due to their geometry, which fails to conform to various facial geometries, leading to discomfort and potential leaks.
Innovation Solution
A corrugated sealing flap design with alternating furrows and ridges that extends from the distal edge to the proximal edge of the sealing flap, increasing the opening circumference without altering the height or depth, allowing for better flexibility and conformity to different facial geometries.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Device complexity
If the sealing flap uses traditional convex geometry without reversals, then the structure is simple, but it creates excessive pressure points and red marks on the patient's face
Solution Approach 1:
The sealing flap is segmented into multiple zones with different geometries: a first zone with convex geometry and a second zone with concave geometry (reversal). This segmentation allows different portions of the sealing flap to interact differently with facial features, distributing pressure more evenly and preventing concentration of force at single points.
Solution Approach 2:
The invention introduces a reversal in the sealing flap geometry, transitioning from convex to concave. This inversion creates a geometry that better accommodates the natural contours of the face, particularly around the nose bridge area, thereby reducing excessive pressure and preventing red marks while maintaining sealing effectiveness.
2Reliability
If the sealing flap has a finite arc length to conform to facial geometries, then it can seal against the face, but it creates excess pressure and red marks when compressed
Solution Approach 1:
The sealing flap incorporates dynamic geometry changes through the reversal feature, allowing the flap to adapt its shape when compressed against the face. The concave portion enables the material to deform more naturally, distributing compressive forces across a larger area and reducing pressure concentration that would otherwise occur with a purely convex geometry.
Solution Approach 2:
The invention changes the geometric parameters of the sealing flap by introducing a reversal from convex to concave geometry. This parameter change allows the sealing flap to maintain adequate arc length for sealing while modifying how the material distributes stress during compression, thereby reducing excess pressure and preventing red marks on the patient's face.
3Adaptability or versatility
If the sealing flap must stretch and flex to conform to all patient faces, then it can accommodate various facial geometries, but it creates shear forces that cause discomfort and pressure
Solution Approach 1:
By dividing the sealing flap into zones with different geometries (convex and concave portions), the invention allows each zone to interact optimally with specific facial features. This segmentation reduces the overall shear forces required for conformity, as each zone can deform more naturally with the underlying anatomy rather than requiring the entire flap to stretch uniformly.
Solution Approach 2:
The reversal in geometry changes the physical parameters of the sealing flap, creating regions with different compliance characteristics. This allows the sealing flap to conform to various facial geometries with reduced shear forces, as the concave portion can better accommodate facial contours without requiring excessive material deformation.
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 corrugated design reduces pressure points and red marks by distributing forces more evenly, providing a robust seal across various facial geometries without the need for multiple designs, enhancing patient comfort and therapy compliance.
Implementation Method 1
The sealing flap includes a corrugated portion, wherein the corrugated portion commences at a distal edge of the sealing flap which defines an opening in the sealing flap and extends toward a proximal edge of the sealing flap along at least a portion of a width of the sealing flap including the top outer surface. The corrugated portion includes a series of alternating furrows and ridges
Implementation Method 2
because the length of the sealing flap distal end is finite, when compressed against the patient's face, it tends to create excess pressure and resultant red marks across and on the patient's face... the finite opening circumference of the sealing flap (typically made of an elastomeric material such as TPE, silicone, rubber, etc.) must flex and stretch into the nose bridge
Data Source
AI summary
A cushion (26) for a patient interface device includes a support wall portion having a first edge and an opposite second edge, and a sealing flap (40) extending in a cantilevered fashion inwardly from the second edge and toward a longitudinal axis of the cushion such that when the patient interface device is donned a portion of the face of the user will engage the top outer surface of the sealing flap to form a seal. The sealing flap includes a corrugated portion (56), wherein the corrugated portion commences at a distal edge of the sealing flap and extends toward a proximal edge of the sealing flap along at least a portion of a width of the sealing flap. The corrugated portion includes a series of alternating furrows and ridges.