Knitted Patient Interface Headgear for Stable, Comfortable Sealing
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Solution Overview
Problem
Existing respiratory therapy devices and patient interfaces suffer from discomfort, poor fit, difficulty of use, and reduced compliance due to inadequate seal-forming structures and stabilizing mechanisms, leading to inefficacy in treating respiratory disorders.
Innovation Solution
A patient interface with a positioning and stabilizing structure comprising an integrally formed knitted strap, featuring varying mechanical properties and ventilation regions, designed to maintain a secure seal and therapeutic pressure during sleep, while allowing breathability and ease of use.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a conventional patient interface with seal-forming structure is used, then therapy pressure can be delivered to treat respiratory disorders, but the patient experiences discomfort and poor fit leading to reduced compliance
Solution Approach 1:
The headgear strap is constructed with different knitting structures in different regions: a first region with a first knitting structure providing elasticity and comfort for patient contact, and a second region with a second knitting structure providing rigidity for structural support. This local differentiation allows the single piece to simultaneously provide both comfort and stable seal formation, resolving the contradiction between patient compliance and therapeutic pressure delivery.
2Reliability
If a rigid stabilizing structure is used to maintain seal, then therapeutic pressure is maintained, but patient comfort is reduced
Solution Approach 1:
The headgear strap employs region-specific knitting structures where the first region contacts the patient with a comfortable elastic knitting structure, while the second region provides rigidity for seal stabilization. This spatial differentiation of material properties allows the same component to simultaneously reduce patient discomfort and maintain seal stability.
Solution Approach 2:
The headgear strap integrates two different knitting structures within a single piece, creating a composite structure that combines the properties of elasticity and rigidity. This composite approach allows different regions to fulfill different functions: comfort where needed and stability where required, resolving the contradiction between seal stability and patient comfort.
3Adaptability or versatility
If multiple separate straps are used for positioning, then adjustability is improved, but device complexity increases
Solution Approach 1:
The invention combines multiple functional straps into a single integrated headgear strap made by flat knitting. This single piece simultaneously provides positioning, stabilizing, and adjusting functions that would traditionally require multiple separate components. The merging reduces device complexity while maintaining adaptability through the inherent flexibility and adjustability of the knitted structure.
Solution Approach 2:
The single headgear strap performs multiple functions: it positions the patient interface, stabilizes the seal, and allows adjustment. By making the strap multi-functional through its design with different knitting structures and configurations, the invention eliminates the need for separate dedicated components for each function, reducing overall device complexity while maintaining versatility.
4Reliability
If a non-breathable strap material is used, then seal integrity is maintained, but patient comfort during sleep is reduced
Solution Approach 1:
The headgear strap uses different knitting structures in different regions, where the first region has properties suitable for patient comfort including breathability, while the second region provides seal stability. This local differentiation allows the strap to simultaneously maintain seal integrity and provide breathability where it contacts the patient, resolving the contradiction between these two requirements.
Data Source
AI summary
A patient interface includes a positioning and stabilising structure having headgear comprising a ring strap portion with a superior portion configured to overlay the parietal bones of the patient's head in use and an inferior portion configured to overlay or lie inferior to the occipital bone of the patient's head in use. The ring strap portion defines a loop having a pair of upper strap portions configured to connect between the ring strap portion and a cushion assembly in use on a respective side of the patient's head superior to an otobasion superior. The headgear may comprise a rigidised portion. The headgear may be integrally formed by flat knitting and the strap portions may include blind guides to provide tactile indications of the locations of fastening portions.


