Nasal Patient Interface Cushion Segmentation for Comfortable Sealing
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Solution Overview
Problem
Existing patient interfaces for respiratory therapy are often obtrusive, uncomfortable, poorly fitting, and difficult to use, especially for long periods or when unfamiliar, leading to issues with seal integrity and patient compliance.
Innovation Solution
A patient interface with a seal-forming structure that is removable for cleaning, lightweight, unobtrusive, and quiet in use, featuring a cushion assembly with a plenum chamber and a positioning and stabilising structure that maintains a therapeutic pressure throughout the respiratory cycle.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If a patient interface is designed to be comfortable and unobtrusive, then patient compliance improves, but seal integrity may deteriorate
Solution Approach 1:
The patient interface is divided into separable components: a cushion assembly with seal-forming structure and a frame assembly. This segmentation allows the cushion to be removed for cleaning while maintaining seal integrity during use, and enables customization of the frame to fit different patient faces without compromising comfort or seal effectiveness.
Solution Approach 2:
The cushion assembly is designed to be movable and adjustable on the frame, allowing it to be positioned optimally for each patient. The cushion can be removed, repositioned, or replaced to maintain both comfort and effective sealing, adapting to different patient needs and facial structures dynamically.
2Weight of moving object
If the patient interface is made lightweight and unobtrusive, then comfort improves, but structural strength may worsen
Solution Approach 1:
The interface is segmented into a lightweight cushion assembly and a supportive frame assembly. The cushion provides necessary sealing and comfort with minimal weight, while the frame provides structural strength and stability. This division allows each component to be optimized independently for its specific function.
Solution Approach 2:
Different parts of the interface have different material properties optimized for their specific functions. The cushion uses soft, compliant materials for comfort and sealing, while the frame uses rigid materials for structural support. This local differentiation of material quality allows the overall structure to be lightweight yet strong where needed.
3Ease of repair
If the seal-forming structure is made removable for cleaning, then ease of maintenance improves, but device complexity increases
Solution Approach 1:
The cushion assembly is designed as a separable component that can be easily removed from the frame for cleaning. This segmentation provides dedicated access to the seal-forming structure for hygiene maintenance while using relatively simple connection mechanisms that do not significantly increase overall device complexity.
4Ease of operation
If the patient interface is designed for ease of use, then patient compliance improves, but manufacturing precision requirements increase
Solution Approach 1:
The interface is divided into a cushion assembly and frame assembly that can be manufactured separately with standardized connection interfaces. This segmentation allows for modular manufacturing with controlled precision requirements at each stage, while the overall system maintains ease of use through simple assembly and adjustment mechanisms.
Solution Approach 2:
The cushion assembly is designed to be adjustable and repositionable on the frame, allowing compensation for manufacturing tolerances and individual patient variations. This dynamic adjustability maintains ease of use while reducing the stringency of manufacturing precision requirements.
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 patient interface provides improved comfort, ease of use, and manufacturability, while maintaining effective seal integrity and therapeutic pressure, thereby enhancing patient compliance and treatment efficacy.
Implementation Method 1
a seal-forming structure (3100) constructed from an elastomeric material... constructed and arranged to form a seal against the patient's face when force is applied
Implementation Method 2
a plenum chamber (3200) constructed and arranged to be pressurised at a pressure above ambient pressure in use... configured to maintain a therapy pressure in a range of about 4cmH2O to about 30 cmH2O above ambient air pressure
Data Source
AI summary
A nasal patient interface for delivery of a supply of pressurised air or breathable gas to an entrance of a patient's airways includes a cushion member that includes a retaining structure and a seal-forming structure permanently connected to the retaining structure, a frame member attachable to the retaining structure, and a positioning and stabilising structure releasably attachable to the frame member.