Dome-and-Saddle Patient Interface Seal With Varying Thickness
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Solution Overview
Problem
Existing respiratory therapy devices and interfaces, such as CPAP masks, suffer from discomfort, poor fit, and reduced compliance due to inadequate sealing mechanisms, leading to inefficacy and reduced patient adherence.
Innovation Solution
A patient interface with a seal-forming structure that includes a silicone rubber sealing structure with a tie or loop mechanism to maintain a seal against the face, a low-profile design for side sleeping, and a gas washout vent to minimize CO2 rebreathing, ensuring effective pressure maintenance and comfort during therapy.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a conventional sealing structure is used in patient interfaces, then the device can maintain therapeutic pressure, but it causes discomfort and poor fit leading to reduced patient compliance
Solution Approach 1:
The sealing structure incorporates regions of varying thickness with different mechanical properties. Thinner regions provide flexibility and comfort at contact points, while thicker regions maintain structural integrity and sealing pressure. This local differentiation allows the seal to adapt to individual patient anatomy, improving both sealing effectiveness and patient compliance.
Solution Approach 2:
The sealing structure's thickness parameter is varied across different regions to optimize performance. By changing the thickness parameter from uniform to graduated, the seal achieves better conformity to facial contours, reducing discomfort while maintaining adequate seal pressure for therapeutic effectiveness.
2Strength
If a thick uniform sealing structure is used, then the seal is strong and maintains pressure, but it causes discomfort and poor fit
Solution Approach 1:
Different regions of the sealing structure have different thicknesses tailored to their specific functions. Contact regions have reduced thickness for comfort, while support regions maintain greater thickness for strength. This local quality differentiation resolves the contradiction between seal strength and patient comfort.
Solution Approach 2:
The sealing structure is segmented into functional zones with varying thickness characteristics. This segmentation allows each zone to perform its specific function optimally - comfort zones provide flexibility while structural zones provide strength - without compromising overall seal performance.
3Ease of manufacture
If a simple seal design is used, then the device is easy to manufacture, but it provides inadequate sealing leading to therapy inefficacy
Solution Approach 1:
The gradient thickness profile is achieved through controlled parameter changes during manufacturing. By systematically varying the thickness parameter across the sealing structure, the design achieves complex functional performance while remaining compatible with standard manufacturing processes for elastomeric components.
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 design enhances patient compliance and therapy efficacy by providing a comfortable, secure seal and reducing CO2 rebreathing, even during side sleeping, thus improving treatment outcomes for respiratory disorders.
Implementation Method 1
a seal-forming structure including a tie or loop that extends between a first interior surface region of the seal-forming structure that is opposite the sealing surface and a second interior surface region of the patient interface such that the tie or loop resists deformation of the seal-forming structure
Implementation Method 2
a gas washout vent to minimize CO2 rebreathing, ensuring effective pressure maintenance and comfort during therapy
Data Source
AI summary
A cushion assembly for a patient interface includes an elastomeric seal-forming portion that includes a dome-shaped superior region and a saddle-shaped inferior region. The elastomeric sealing portion further includes a first support region extending from the saddle-shaped inferior region to the dome-shaped superior region, the first support region having a consistent elastomeric wall thickness that is greater than the elastomeric wall thickness of the dome-shaped superior region and the saddle-shaped inferior region. In addition, the seal-forming portion include a second support region adjacent the first support region that extends from the saddle-shaped inferior region to the dome-shaped superior region, the second support region being bounded by the first support region on a proximal side and having a distal side opposite the proximal side, the elastomeric wall thickness in the second support region increases from the distal side to the proximal side.