Modular Headgear Clips for Nasal and Oro-Nasal Mask Fit
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Solution Overview
Problem
Existing respiratory therapies and devices for treating respiratory disorders, such as CPAP and NIV, face challenges with comfort, compliance, and efficacy due to poorly fitting masks, noise, and cumbersome design, leading to reduced patient adherence.
Innovation Solution
A modular patient interface with adjustable nasal and oro-nasal masks and customizable headgear configurations, along with a CPAP system, to enhance comfort and ease of use, allowing conversion between mask types and improved seal formation with customizable straps and clips for better fit and stability.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Adaptability or versatility
If a fixed-design mask is used, then manufacturing is simple, but it cannot adapt to different patient face shapes and sizes
Solution Approach 1:
The mask is divided into multiple adjustable components including headgear sections, straps, and cushion assemblies that can be independently adjusted to fit different patient face shapes and sizes while maintaining overall mask functionality
Solution Approach 2:
The mask incorporates adjustable headgear and strap systems that allow dynamic adaptation to various patient anatomies through manual adjustment of strap lengths, tension, and positioning to achieve optimal fit for each individual patient
2Ease of operation
If a single mask design is used for all patients, then device complexity is low, but comfort and compliance deteriorate
Solution Approach 1:
The mask system allows patients to dynamically adjust headgear tension, strap positioning, and cushion fit to achieve optimal comfort and seal, thereby improving compliance without requiring multiple different mask designs
Solution Approach 2:
A single mask design incorporates multiple adjustment mechanisms and configurable components that can accommodate various patient needs and preferences, providing universal applicability across different patient populations while maintaining ease of use
3Adaptability or versatility
If the headgear is fixed in configuration, then manufacturing is easier, but it cannot provide optimal positioning for different mask types
Solution Approach 1:
The headgear is segmented into separate adjustable sections with independent straps and connection points, allowing each component to be manufactured using standard processes while enabling diverse configurations when assembled
Solution Approach 2:
The headgear incorporates adjustable straps and connection mechanisms that allow the same manufactured components to be configured in multiple ways to optimize positioning for different mask types and patient anatomies
4Ease of operation
If the mask structure is rigid, then structural strength is high, but comfort and seal formation deteriorate
Solution Approach 1:
The mask incorporates flexible cushion materials and compliant sealing surfaces that can conform to the patient's face contours to achieve optimal seal formation, while the overall mask structure maintains sufficient strength through its frame and headgear support system
Solution Approach 2:
The mask design allows the cushion and sealing portions to dynamically adapt to patient face shape through material compliance and adjustable positioning mechanisms, while maintaining structural integrity through the rigid frame and headgear assembly
Data Source
AI summary
A patient interface to deliver air at a positive pressure to a patients airways, including nasal and mouth cushions; a positioning and stabilizing structure to provide a force to hold the nasal seal-forming structure or the nasal seal and the mouth seal-forming structure in position on a patients head, the positioning and stabilizing structure comprising nasal and oro-nasal headgear configurations and including left and right headgear sections, a pair of nasal headgear clips connecting the nasal headgear to the left and right headgear sections at a first angle and/or position applying nasal headgear forces to the nasal seal-forming structure, and a pair of oro-nasal headgear clips connecting the oro-nasal headgear to the left and right headgear sections at a second angle and/or position applying oro-nasal forces to the mouth seal forming structure in the oro-nasal configuration. The first angle and/or position is different than the second angle and/or position.


