Nasal Patient Interface Seal Structure for Comfort and Leak Control
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Solution Overview
Problem
Existing patient interfaces for respiratory therapy are often obtrusive, poorly fitting, uncomfortable, and difficult to use, leading to leaks and discomfort, especially when worn for extended periods.
Innovation Solution
A patient interface with a removable seal-forming structure and a hard-to-hard connection, featuring a plenum chamber and connection portion made from different materials, allowing for easy cleaning and improved fit, along with a gas delivery system using a helical coil and vent technology to minimize noise and leaks.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If a patient interface is designed to be comfortable and well-fitting, then therapy compliance improves, but device complexity increases
Solution Approach 1:
The patient interface is divided into separate components: a headgear assembly and a mask assembly. The mask assembly includes a cushion member with a seal-forming structure that can be detached from the headgear. This segmentation allows each component to be optimized independently for comfort and fit while reducing overall device complexity through modular design.
Solution Approach 2:
The seal-forming structure on the cushion member is designed to be deformable and adaptable to different patient faces. The cushion member can be selectively positioned and secured in different locations on the patient's face, allowing dynamic adjustment to achieve optimal fit and comfort for each user.
2Ease of repair
If the seal-forming structure is made removable for cleaning, then ease of maintenance improves, but device complexity increases
Solution Approach 1:
The seal-forming structure is integrated into the cushion member as a removable component that can be detached from the headgear assembly. This segmentation allows the seal-forming structure to be easily removed for cleaning and disinfection without requiring disassembly of the entire device, improving maintenance ease while keeping the overall structure relatively simple.
3Manufacturing precision
If hard-to-hard connection is used for the plenum chamber and connection portion, then manufacturing precision and seal integrity improve, but device complexity increases
Solution Approach 1:
The plenum chamber and connection portion are combined into a single integrated component formed from one piece of material. This merging eliminates the need for separate connections and assemblies, improving seal integrity by removing potential leak points at joints while actually reducing device complexity through consolidation.
4Weight of moving object
If the patient interface is designed to be light-weight and unobtrusive, then comfort improves, but structural strength may be compromised
Solution Approach 1:
The cushion member is constructed from a flexible material that can be formed into a thin, lightweight structure while maintaining sufficient strength and durability. The flexible nature of the material allows it to conform to the patient's face while providing adequate structural support for the seal-forming function, achieving both light weight and strength.
Data Source
Figure 1a
Figure 1b
Figure 1c
AI summary
A patient interface comprises: a plenum chamber (3200) pressurisable to a therapeutic pressure above ambient air pressure, said plenum chamber including a plenum chamber inlet port sized and structured to receive a flow of air at the therapeutic pressure for breathing by a patient; a seal-forming structure (3100) constructed and arranged to seal with a region of the patient's face surrounding an entrance to the patient's airways, said seal-forming structure being constructed and arranged such that the flow of air at said therapeutic pressure is delivered to an entrance to the patient's nares, and the seal-forming structure being constructed and arranged to maintain said therapeutic pressure in the plenum chamber throughout the patient's respiratory cycle in use; a positioning and stabilising structure configured to hold the seal-forming structure in a therapeutically effective position on the patient's head, the positioning and stabilising structure comprising a tie, and the tie being constructed and arranged so that at least a portion overlies a region of the patient's head superior to an otobasion superior of the patient's head in use; and a vent structure formed in the plenum chamber and configured to allow a continuous flow of gases exhaled by the patient from an interior of the plenum chamber to ambient; wherein the patient interface is configured to leave the patient's mouth uncovered during therapy, wherein the seal-forming structure is shaped and dimensioned such that no portion of the seal-forming structure enters into the patient's nares during use, wherein the seal-forming structure (3100) comprises two lateral support regions (3112.3; 3117), each located at a lateralmost side of the seal-forming structure (3100), and a medial region (3112.1; 3113, 3115) positioned between the lateral support regions, the naris openings passing through the seal-forming structure at the medial region, wherein the lateral support regions (3112.3; 3117) are thicker than the medial region (3112.1; 3113, 3115), and wherein the seal-forming structure further comprises two mid-lateral regions (3112.2), each of the mid-lateral regions being positioned laterally outward from and adjacent to the medial region and medially inward from and adjacent to a corresponding one of the lateral support regions, the mid-lateral regions being thicker than the medial region and thinner than the lateral support regions.