Textile seal with silicone layer
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Solution Overview
Problem
Current respiratory therapy devices, such as CPAP machines and masks, face challenges in comfort, compliance, and effectiveness due to issues like poor fit, discomfort, and difficulty in use, particularly for patients with sleep disordered breathing, leading to reduced patient adherence to treatment.
Innovation Solution
A patient interface with a textile membrane seal-forming structure that is air-impermeable, stretchy, and designed to maintain therapeutic pressure during sleep, featuring a plenum chamber and positioning stabilizing structure to ensure a secure fit and comfortable use, reducing leaks and pressure points.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a conventional seal-forming structure is used in a patient interface, then the device can be manufactured with standard materials and processes, but the patient experiences discomfort, poor fit, and reduced compliance due to leaks and pressure points
Solution Approach 1:
The seal-forming structure uses a composite material system consisting of a porous elastomeric material providing cushioning and conformability, combined with a non-porous material layer (such as silicone or thermoplastic elastomer) that provides air impermeability. This composite structure simultaneously achieves reliable sealing (preventing leaks) and patient comfort (through soft, conformable contact with facial contours), resolving the contradiction between seal effectiveness and comfort.
Solution Approach 2:
The invention changes the physical parameters of the seal material by using a porous elastomeric material with specific porosity characteristics that allows the material to be both soft/compliant for comfort and yet form an effective seal when pressurized. The material's porosity, elasticity, and surface properties are optimized to provide comfort during donning and wearing while maintaining therapeutic pressure and preventing leaks during use.
2Ease of operation
If the seal-forming structure is made from soft, compliant material to improve comfort, then patient comfort increases, but the structure may deform under therapeutic pressure leading to reduced seal effectiveness
Solution Approach 1:
The composite structure combines a soft, porous elastomeric material that provides comfort and conformability with a non-porous material layer that maintains structural integrity and air impermeability under therapeutic pressure. The non-porous layer prevents deformation that would compromise sealing, while the porous elastomeric layer maintains comfort, thus resolving the contradiction between comfort and seal effectiveness under pressure.
Solution Approach 2:
The seal-forming structure is segmented into distinct functional layers: a porous elastomeric material layer for comfort and conformability, and a non-porous material layer for structural support and air impermeability. This segmentation allows each layer to perform its specific function optimally - the soft layer contacts the patient for comfort while the non-porous layer maintains seal integrity under pressure.
3Reliability
If the patient interface maintains high therapeutic pressure to ensure effective treatment, then treatment effectiveness improves, but patient comfort decreases due to increased pressure points and discomfort
Solution Approach 1:
The porous elastomeric material layer acts as a cushioning layer that absorbs and distributes pressure before it reaches the patient's face. This beforehand cushioning allows the interface to maintain high therapeutic pressure for effective treatment while the elastomeric layer protects the patient from discomfort and pressure points, resolving the contradiction between treatment effectiveness and comfort.
Solution Approach 2:
The elastomeric material's porosity and elasticity parameters are optimized to allow pressure transmission necessary for effective treatment while simultaneously providing pressure distribution and cushioning to maintain comfort. The material properties are tuned to balance therapeutic pressure requirements with patient comfort 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 solution enhances patient compliance and comfort by providing a secure, comfortable fit that maintains therapeutic pressure, reducing leaks and pressure points, thereby improving the effectiveness of respiratory therapy.
Implementation Method 1
an air impermeable silicone layer applied to a textile material
Data Source
AI summary
A patient interface comprises a cushion assembly including a textile membrane. The textile membrane includes an air impermeable silicone layer applied to a textile material. The textile material comprises 1) nylon and/or polyester, and 2) elastane. A yarn count of the nylon and/or polyester is in a range of 20-80 denier, and the textile material has stretchability in both a direction of the wales and a direction of the course.