Patient Interface Strap Plenum Chamber Seal Integrity
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Solution Overview
Problem
Existing respiratory therapy systems for treating respiratory disorders such as Obstructive Sleep Apnea (OSA) and Cheyne-Stokes Respiration (CSR) face challenges with patient compliance due to uncomfortable, difficult-to-use, and aesthetically unappealing mask designs, which can lead to reduced effectiveness of the therapy.
Innovation Solution
A patient interface system with a positioning and stabilising structure, including a strap configured to hold a seal-forming structure in a therapeutically effective position on the patient's head, and a plenum chamber that maintains therapeutic pressure throughout the respiratory cycle, enhancing comfort and usability.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a mask is designed to provide effective respiratory therapy, then therapeutic effectiveness is improved, but comfort and ease of use deteriorate
Solution Approach 1:
The patient interface is divided into separate modular components including a headgear assembly, a cushion assembly, and a connector assembly. This allows each component to be optimized independently for its specific function while improving overall comfort and ease of use.
Solution Approach 2:
The headgear incorporates adjustable straps and flexible positioning mechanisms that allow the mask to adapt dynamically to different patient head shapes and sizes, improving both comfort and seal integrity throughout the respiratory cycle.
2Ease of operation
If a mask design is improved for comfort, then ease of use is improved, but seal integrity deteriorates
Solution Approach 1:
The cushion assembly features localized soft cushioning zones at the contact points with the patient's face, while maintaining a rigid structural framework. This provides comfort at critical sealing surfaces without compromising the overall structural integrity needed for maintaining seal.
Solution Approach 2:
The mask incorporates composite construction combining rigid materials for structural support and sealing surfaces with flexible, soft materials for patient contact areas. This composite approach simultaneously achieves comfort and reliable seal integrity.
3Reliability
If the mask structure is made complex to improve seal integrity, then reliability is improved, but device complexity increases
Solution Approach 1:
The headgear assembly serves multiple functions simultaneously: it provides structural support, adjusts to different patient anatomies, secures the cushion in proper position, and maintains seal integrity. This multi-functionality reduces the need for additional separate components.
Solution Approach 2:
The connector assembly integrates the airway connector, cushion attachment mechanism, and headgear connection points into a single unified structure, reducing overall device complexity while maintaining reliable sealing.
4Device complexity
If existing mask designs are used, then device complexity is reduced, but patient compliance deteriorates
Solution Approach 1:
The adjustable headgear and flexible cushion assembly allow the mask to adapt dynamically to patient movement and different sleeping positions, maintaining comfort and seal integrity throughout the night, thereby improving compliance.
Solution Approach 2:
The mask incorporates adjustable parameters including strap tension, cushion position, and headgear configuration that can be customized to each patient's preferences and anatomical features, improving comfort and compliance without significantly increasing complexity.
Data Source
AI summary
A patient interface for treatment of sleep disordered breathing, the patient interface comprising: a strap comprising: an anterior portion configured to be positioned anterior to the patient's face in use; and a seal-forming structure formed by or provided to the anterior portion; wherein the anterior portion of the strap is shaped to form a plenum chamber; wherein the strap forms a positioning and stabilising structure to provide a force to hold the seal-forming structure in a therapeutically effective position on the patient's head.