Variable-Knit Headgear Strap for Patient Interface Seal Stability
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Solution Overview
Problem
Existing respiratory therapy devices, particularly patient interfaces, suffer from discomfort, poor fit, and reduced compliance due to inadequate seal-forming structures and stabilization mechanisms, leading to leaks and reduced effectiveness in treating sleep disordered breathing.
Innovation Solution
A patient interface with a positioning and stabilizing structure featuring a knitted strap with varying mechanical properties and a cushion assembly that maintains a seal and therapeutic pressure throughout the respiratory cycle, using a one-piece knitted headgear strap to secure the seal-forming structure effectively on the patient's head.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a conventional patient interface with seal-forming structure is used, then the device can deliver therapeutic pressure to treat sleep disordered breathing, but the seal-forming structure causes discomfort, poor fit, and reduced patient compliance
Solution Approach 1:
The patent uses a flexible cushion assembly with a seal-forming structure made from elastic material that conforms to the patient's face contours. The cushion includes a breathable membrane that flexes with respiratory movements while maintaining the seal, resolving the contradiction between maintaining therapeutic pressure and ensuring patient comfort during breathing cycles.
Solution Approach 2:
The positioning and stabilizing structure incorporates adjustable headgear straps and buckles that allow dynamic adjustment to fit different patient head sizes and shapes. The seal-forming cushion dynamically adapts to facial movements during sleep, maintaining both the therapeutic seal and patient comfort throughout the night.
2Reliability
If a rigid seal-forming structure is used to maintain therapeutic pressure, then pressure delivery is reliable, but the structure causes discomfort and leaks due to inability to accommodate facial movements
Solution Approach 1:
The cushion assembly employs a flexible breathable membrane that maintains the pressurized seal while flexing with nasal and facial movements during respiration. This flexible structure preserves pressure integrity without rigid constraints, preventing leaks while accommodating natural facial dynamics.
Solution Approach 2:
The seal-forming structure utilizes material with specific elastic properties that allow controlled deformation under pressure. The cushion material changes its physical parameters (flexibility, breathability) to maintain seal integrity during inhalation and exhalation cycles, ensuring both pressure reliability and movement accommodation.
3Reliability
If a complex positioning and stabilizing structure is used to secure the patient interface, then fit and stability are improved, but device complexity and difficulty of use increase
Solution Approach 1:
The positioning and stabilizing structure integrates multiple functions into a unified headgear assembly with interconnected straps and buckles that work together as a single system. This merged design provides stable positioning without requiring separate adjustment components, reducing perceived complexity while maintaining reliability.
Solution Approach 2:
The headgear straps serve multiple functions: positioning the cushion assembly, stabilizing the interface on the patient's head, and providing adjustable fit for different head sizes. This multi-functional design reduces the number of separate components needed, simplifying the overall device while improving stability.
Data Source
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AI summary
A patient interface includes a positioning and stabilising structure having a knitted headgear strap comprising physical properties and/or characteristics that vary across the headgear strap. The entire headgear strap or portions thereof may be knitted as a single piece of material directly into its final shape. The variations in physical properties and/or characteristics may be provided by different knit structures and/or textile compositions.