Continuous Loop Seal Structure for Patient Interface Pressure
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Solution Overview
Problem
Current respiratory therapy devices and interfaces for treating disorders such as Obstructive Sleep Apnea and Chronic Obstructive Pulmonary Disease face challenges with comfort, compliance, and efficacy due to issues like poor fitting, noise, and difficulty in use, leading to reduced patient compliance and suboptimal treatment outcomes.
Innovation Solution
A patient interface with a seal-forming structure that forms a continuous loop with an interior surface, providing a therapeutic pressure of at least 6 cmH2O, and a positioning and stabilizing structure that holds the interface effectively on the patient's head, along with a vent structure for continuous gas exhalation, allowing mouth breathing without pressurized air, and a design that accommodates various face shapes and sizes for improved comfort and compliance.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a seal-forming structure with continuous loop support is used, then sealing effectiveness and comfort are improved, but device complexity increases
Solution Approach 1:
The support structure and seal-forming structure are merged into a single continuous loop component, eliminating the need for separate support elements and reducing assembly complexity while maintaining structural integrity and sealing effectiveness
Solution Approach 2:
The continuous loop structure serves multiple functions simultaneously: it provides structural support, forms the seal against the patient's face, and distributes pressure evenly. This multi-functionality reduces the need for additional specialized components
2Reliability
If therapeutic pressure is maintained at least 6 cmH2O, then treatment efficacy is improved, but patient comfort deteriorates
Solution Approach 1:
The seal-forming structure incorporates a cushioning portion with different material properties than the support structure, providing localized softness and comfort at the contact points with the patient's face while maintaining the rigid support needed to sustain therapeutic pressure
Solution Approach 2:
The cushioning portion is pre-integrated into the seal-forming structure to provide comfort before the device is even worn, preventing discomfort from developing during therapy rather than attempting to mitigate it afterward
3Adaptability or versatility
If the seal-forming structure accommodates various face shapes and sizes, then adaptability is improved, but manufacturing precision requirements increase
Solution Approach 1:
The seal-forming structure is designed with flexible, elastomeric materials that can dynamically adapt to different face shapes and sizes through elastic deformation, allowing a single design to fit multiple patients without requiring custom manufacturing for each individual
Solution Approach 2:
The elastomeric material properties are selected to provide optimal balance between flexibility for adaptation and structural integrity for maintaining seal, with material parameters chosen to work across a range of face geometries
4Ease of operation
If mouth breathing is allowed without pressurized air, then patient compliance is improved, but pressure maintenance difficulty increases
Solution Approach 1:
The patient interface is segmented to provide separate pathways: the seal-forming structure maintains pressure sealing around the nose while the mouth remains open and unobstructed, allowing independent control of nasal and oral breathing zones
Solution Approach 2:
The seal-forming structure acts as an intermediary that selectively applies pressure sealing only where needed (around the nares) while leaving other areas (mouth) open, using its specific geometric configuration to mediate between pressure requirements and breathing freedom
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 treatment efficacy by providing a comfortable, well-fitting interface that maintains therapeutic pressure and allows for effective gas exchange, reducing noise and discomfort, thereby improving respiratory therapy outcomes.
Implementation Method 1
maintains therapeutic pressure of at least 6 cmH2O above ambient in a plenum chamber
Implementation Method 2
positioning and stabilizing structure to provide a force to hold the seal-forming structure in a therapeutically effective position
Implementation Method 3
vent structure to allow a continuous flow of gases exhaled by the patient from an interior of the plenum chamber to ambient
Data Source
Figure 1A
Figure 1B
Figure 1C
AI summary
The invention relates to a seal-forming structure for a patient interface. The structure is constructed and arranged to form a seal with a region of the patient's face surrounding an entrance to the patient's airways. The structure is constructed and arranged to maintain a therapeutic pressure in a plenum chamber throughout the patient's respiratory cycle. The structure comprises a patient-contacting surface, a posterior opening formed in the patient-contacting surface, and a support structure extending from a first location on the patient-contacting surface to a second location on an interior surface of the seal-forming structure. The support structure and the interior surface form a continuous loop. The patient interface is configured to allow the patient to breath from ambient through their mouth in the absence of a flow of pressurised air through the plenum chamber inlet port, or the patient interface is configured to leave the patient's mouth uncovered. A superior portion of the seal-forming structure is structured to engage the patient's nose inferior to the patient's nasal bone.