Multi-layer cushion assembly for patient interface seal integrity
Find Innovative SolutionsGenerate Solutions
Solution Overview
Problem
Existing patient interface cushions for airway pressure support systems are uncomfortable due to scratchy edges and difficult alignment of large openings, which can lead to a weak seal and reduced structural integrity, compromising the effectiveness of pressure support therapy for sleep disordered breathing conditions like sleep apnea.
Innovation Solution
A patient interface design featuring a support layer with a dense array of small thru-holes and an elastic patient engaging layer with strategically positioned thru-holes to align with nasal openings, providing a comfortable and secure seal by minimizing raw edge contact and ensuring proper alignment, thereby enhancing the delivery of breathing gas.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of manufacture
If a fabric cushion with large openings is used, then the cushion is easier to manufacture, but the alignment of openings becomes difficult and structural integrity is reduced
Solution Approach 1:
The cushion is divided into multiple layers (first cushion layer, second cushion layer, third cushion layer) with different functions. The first layer has laser-cut openings for structural support, the second layer has needle-punched openings for comfort, and the third layer provides sealing. This segmentation allows each layer to be manufactured independently with optimal precision for its specific function, resolving the alignment difficulty.
Solution Approach 2:
The cushion uses a composite structure combining different materials and manufacturing techniques: laser-cut fabric layer for structural integrity, needle-punched nonwoven layer for comfort and softness, and thermoplastic material for sealing. This composite approach allows each material to contribute its strengths while compensating for the weaknesses of others, particularly regarding alignment and structural integrity.
2Productivity
If laser cutting is used for cushion manufacturing, then production efficiency is improved, but edge roughness increases causing discomfort
Solution Approach 1:
A second cushion layer made of needle-punched nonwoven material is introduced as an intermediary between the laser-cut first layer and the patient's skin. This intermediate layer has softer, more comfortable edges that mask the rough laser-cut edges of the first layer, thereby maintaining manufacturing efficiency while eliminating the discomfort caused by rough edges.
Solution Approach 2:
Different regions of the cushion have different material properties and manufacturing methods. The first layer uses laser cutting for structural openings, while the second layer uses needle-punching for softer, more comfortable edges. This local differentiation allows the cushion to maintain both manufacturing efficiency and comfort by applying the appropriate manufacturing technique to each specific region and layer.
3Device complexity
If a single-layer cushion design is used, then the structure is simpler, but seal integrity and comfort are compromised
Solution Approach 1:
The cushion is segmented into three distinct layers, each performing a specific function: the first layer provides structural support and gas flow pathways, the second layer provides comfort and softness, and the third layer provides sealing against the patient's face. This functional segmentation ensures that each layer optimizes for its specific purpose, thereby achieving reliable seal integrity and comfort while maintaining reasonable structural simplicity through modular design.
Data Source
AI summary
A patient interface for use in delivering a flow of breathing gas to an airway of a patient. The patient interface includes a front portion and a rear portion coupled to the front portion. The front portion and the rear portion together define a cavity therebetween which is structured to receive the flow of breathing gas. The rear portion includes a support layer disposed directly adjacent the cavity, the support layer having a region having a plurality of first thru-holes structured to receive the flow of breathing gas from the cavity. The rear portion further includes a patient engaging layer structured to engage the patient at or about the airway of the patient, the patient engaging layer including at least a second thru-hole structured to receive the flow of breathing gas from the plurality of first thru-holes.