Thermoformable Seal Structure for Custom-Fit Patient Interfaces
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Solution Overview
Problem
Existing patient interfaces for respiratory therapies, such as CPAP, suffer from discomfort, poor fit, and reduced compliance due to inadequate sealing and pressure points, leading to potential leaks and reduced effectiveness.
Innovation Solution
A patient interface with a user-formable seal forming structure made from thermoformable materials like polycaprolactone, combined with other materials like silicone or polycarbonate, allowing customization to individual facial features through heating and shaping, enhancing fit and comfort.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Manufacturing precision
If a standard patient interface mask is used, then manufacturing is simple and cost-effective, but the fit is poor and causes pressure points
Solution Approach 1:
The patent incorporates a thermoformable section that allows the user to pre-customize the mask fit to their unique facial contours before use. By heating and shaping the mask material in advance, the device achieves precise fit without requiring complex manufacturing processes for each individual patient.
Solution Approach 2:
The patent utilizes thermoformable material that changes its physical parameters (softness, moldability) when heated. This allows the mask to be transformed from a standard rigid form into a customized conforming shape that matches the patient's facial geometry, resolving the contradiction between standardization and customization.
2Reliability
If the mask is tightly sealed to prevent leaks, then sealing effectiveness improves, but patient comfort deteriorates due to pressure points
Solution Approach 1:
The patent applies different material properties to different sections of the mask. The thermoformable section provides localized customization for precise sealing at critical contact points, while other areas maintain standard material properties for comfort. This localized differentiation allows effective sealing without creating pressure points in non-critical areas.
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
Improves mask fit and sealing, reduces pressure points, and increases patient compliance by providing a customized, comfortable fit for extended wear, particularly during sleep therapy.
Implementation Method 1
a first section of a thermoformable material
Data Source
AI summary
The present specification is directed a method manufacturing a patient interface for treatment of sleep disordered breathing using air pressure by delivery of air to a patient's airway. The method includes locating a shell, a first sub section of a seal forming structure, and a first section of the seal forming structure in a tool. The first sub section includes a groove. The first section is constructed from a thermoformable material. The method further includes introducing a moulding material to the tool and overmolding the shell, the first sub section, and the first section. The moulded material forms a second sub section of the seal forming structure that connects the first sub section to the shell and fully encloses the first section within the groove.