CPAP Patient Interface With Modular Seals and Flexible Headgear Fit
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Solution Overview
Problem
Existing respiratory therapy devices and interfaces suffer from discomfort, poor fit, difficulty of use, and reduced compliance due to inadequate sealing mechanisms, noisy operation, and cumbersome design, leading to suboptimal treatment outcomes for respiratory disorders.
Innovation Solution
A patient interface with a modular frame assembly and cushion system that allows independent connection of the air delivery connector and cushion, featuring dynamic and static seals, swivel elbow, and adjustable headgear for improved fit and comfort, along with a lockout feature to ensure proper assembly, and a vent system to minimize noise and leaks.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a traditional patient interface with integrated cushion and frame is used, then structural simplicity is maintained, but sealing effectiveness and comfort are reduced
Solution Approach 1:
The patient interface is divided into separate modular components: a cushion assembly with seal-forming structure, a frame assembly with headgear connectors, and an air delivery connector. These assemblies can be independently connected and disconnected, allowing each component to be optimized for its specific function while improving overall sealing effectiveness and comfort.
2Adaptability or versatility
If a fixed rigid connection system is used, then assembly simplicity is maintained, but adaptability to different patients and comfort are reduced
Solution Approach 1:
The headgear connectors incorporate flexible portions that can deform to conform to varying facial profiles and headgear configurations. This dynamic flexibility allows the rigid frame assembly to adapt to different patient anatomies and treatment requirements while maintaining structural integrity.
3Reliability
If simple connection mechanisms are used, then ease of assembly is maintained, but sealing reliability and leak prevention are reduced
Solution Approach 1:
The connection between assemblies uses a combination of mechanical features (protrusions and recesses for alignment) and pneumatic sealing (flexible seals that deform under air pressure to create airtight connections). This replaces simple mechanical fastening with a more sophisticated system that uses the therapy air pressure itself to enhance sealing at the connection interfaces.
4Object-affected harmful factors
If traditional venting systems are used, then structural simplicity is maintained, but noise levels and air leaks increase
Solution Approach 1:
The vent system uses an intermediary structure (the flexible seal at the elbow assembly connection) to mediate between the pressurized air delivery system and the external environment. This flexible seal can dynamically open and close to allow controlled venting of excess air and CO2 while minimizing turbulent flow noise and preventing uncontrolled leaks.
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
Enhances patient compliance and therapeutic efficacy by providing a comfortable, easy-to-use, and effective sealing mechanism, reducing noise and leaks, and ensuring proper assembly, thus improving treatment outcomes for respiratory disorders.
Implementation Method 1
a dynamic seal between the air delivery connector and frame assembly
Implementation Method 2
a static seal between the frame assembly and cushion assembly
Implementation Method 3
each of the arms including one or more flexible portions structured and arranged to conform to varying facial profiles
Data Source
Figure 1A
Figure 1B
Figure 1C
AI summary
The present invention relates to a patient interface for sealed delivery of a flow of air at a continuously positive pressure with respect to ambient air pressure to an entrance to a patient's airways including at least entrance of a patient's nares, wherein the patient interface is configured to maintain a therapy pressure in a range of about 4 cmH20 to about 30 cmH20 above ambient air pressure in use, throughout a patient's respiratory cycle, while the patient is sleeping, to ameliorate sleep disordered breathing; said patient interface comprising: a headgear including a pair of straps; a frame assembly including a shroud and a headgear connector operatively attachable to the headgear; a cushion assembly including a shell and a seal-forming structure provided to the shell and structured to form a seal with a patient's nose and/or mouth, the shell and the seal- forming structure cooperating to form a plenum chamber, the shell being constructed of a relatively rigid material and the seal-forming structure being constructed of a relatively flexible or pliable material, wherein the cushion assembly is structured to releasably connect to the shroud via a snap-fit connection; wherein the frame assembly includes an upper headgear connector structured to connect to the pair of straps, the upper headgear connector including a shroud connection portion connected to the shroud and a pair of headgear connector arms extending from respective sides of the shroud connection portion and structured to connect to respective headgear straps, each of the headgear connector arms including one or more flexible portions structured and arranged to conform to varying facial profiles.