Patient Interface Frame and Cushion Coupling for Seal Integrity
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Solution Overview
Problem
Existing patient interface devices for non-invasive ventilation and pressure support therapies are not comfortable enough for extended wear, leading to potential non-compliance due to leaks and discomfort, especially during treatments like CPAP for sleep apnea.
Innovation Solution
A patient interface device with a cushion and frame design that includes a torus-shaped portion, adjustable arm members, and a coupling mechanism with locating features, along with a headgear clip for secure strap attachment, to minimize leaks and enhance comfort by providing a continuous seal and easy adjustment.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a traditional mask shell and cushion design is used, then the device structure is simple, but patient comfort is insufficient leading to leaks during extended wear
Solution Approach 1:
The device is divided into distinct functional components: a cushion assembly with front and rear portions for sealing, a separate frame structure with torus-shaped portion, and a coupling mechanism. This segmentation allows each component to be optimized for its specific function while maintaining overall simplicity.
Solution Approach 2:
The frame includes a torus-shaped portion and the cushion is designed with curved surfaces that conform to facial contours. This curvature enables better adaptation to the patient's face shape, improving seal reliability without requiring complex adjustable mechanisms.
2Reliability
If the cushion and frame are tightly secured to prevent leaks, then seal reliability improves, but patient comfort decreases due to pressure and restriction
Solution Approach 1:
Different portions of the cushion have different properties: the front portion is structured to receive coupling mechanisms and maintain position, while the rear portion is designed to engage the user's face and provide sealing. This local differentiation allows the sealing areas to be secure while other areas remain comfortable.
Solution Approach 2:
The coupling mechanism allows for adjustable positioning of the frame relative to the cushion, enabling the device to adapt to different patient faces and comfort requirements while maintaining reliable sealing through the torus-shaped portion engaging with the cushion's groove.
3Ease of operation
If the device is designed for easy cleaning and simple structure, then ease of operation improves, but seal reliability and leak prevention worsen
Solution Approach 1:
The separable design of the cushion and frame components, connected through a simple groove-coupling mechanism, allows each component to be easily removed and cleaned independently while maintaining effective sealing through the torus-shaped coupling portion.
4Adaptability or versatility
If adjustable straps and headgear are used to secure the mask, then adaptability to different patients improves, but device complexity increases
Solution Approach 1:
The torus-shaped frame portion with its opening for the coupling mechanism serves multiple functions: it provides structural support, enables coupling with the cushion, and works with standard headgear straps for adjustment. This multi-functionality reduces the need for additional specialized components.
Data Source
AI summary
A patient interface includes a cushion having a body with a front portion and a rear portion. The front portion has a lower opening structured to receive a flow of a treatment gas and a coupling mechanism. The rear portion is structured to engage a user's face and provide a generally continuous seal therewith. The patient interface further includes a frame having a torus shaped portion defining an opening. The opening has at least a portion of the coupling mechanism disposed therein.