Dual Seal Patient Interface for NIPPV Leakage Control
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Solution Overview
Problem
Non-invasive positive pressure ventilation (NIPPV) therapies face challenges due to air leakage between the patient interface and the face, leading to reduced therapy effectiveness, patient discomfort, and disturbances such as noise and eye irritation, as existing solutions struggle to achieve a perfect seal without increasing pressure or wasting supplemental oxygen.
Innovation Solution
A patient interface with multiple seals and a leak reduction mechanism, including inflatable seals and vacuum lines, is designed to manage leakage by sealing, diffusing, or deflecting air away from the eyes, thereby reducing discomfort and improving therapy efficacy.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a single seal is used at the patient interface, then the device complexity is low, but air leakage occurs reducing therapy effectiveness
Solution Approach 1:
The patient interface is divided into multiple sealing zones with separate seals: a first seal at the periphery and a second seal at the nasal bridge. Each seal operates independently to prevent leakage through different pathways, thereby improving therapy effectiveness without requiring a single complex seal design
Solution Approach 2:
A chin strap is introduced as an intermediary element to support the patient interface and enhance the sealing action of both seals. The chin strap applies downward force to press the seals against the patient's face, improving seal reliability without increasing the complexity of the seals themselves
2Reliability
If pressure is increased to prevent leakage, then leakage is reduced, but patient discomfort and noise increase
Solution Approach 1:
By segmenting the sealing function into two separate seals at different locations (periphery and nasal bridge), the system prevents leakage without needing to increase overall pressure. Each seal handles specific leakage pathways, maintaining comfort while ensuring seal integrity
Solution Approach 2:
The dual seal design allows the system to self-regulate leakage prevention without requiring excessive pressure. The geometry and positioning of the two seals work together to create effective sealing through their combined action rather than through high pressure alone
3Reliability
If a perfect seal is attempted, then leakage is minimized, but the flow generator must work harder increasing energy consumption
Solution Approach 1:
The sealing function is segmented into two separate seals that address different leakage pathways. This segmentation prevents leakage more efficiently than a single seal design, reducing the workload on the flow generator and lowering energy consumption while maintaining reliable sealing
4Stress or pressure
If leak flow is increased to maintain pressure, then pressure is maintained, but supplemental oxygen and humidifier water are wasted
Solution Approach 1:
By implementing two seals at different locations, the system prevents leakage that would otherwise require increased flow compensation. This segmentation maintains airway pressure without excessive leak flow, preventing waste of supplemental oxygen and humidifier water
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 proposed solution effectively minimizes leakage, enhancing the comfort and effectiveness of NIPPV therapies by maintaining a consistent seal, reducing noise, and preventing eye irritation, while optimizing the use of supplemental oxygen and water in humidifiers.
Implementation Method 1
a first seal (50) adapted to contact the patient's face and seal a first space between the patient interface and the patient's face at a first positive pressure; and a second seal (52) adapted to contact the patient's face and seal a second space between the patient interface and the patient's face at a second positive pressure
Implementation Method 2
a vacuum line (44) configured to create a negative pressure in the second space and remove any gas leaking from the first space to the second space
Data Source
AI summary
A patient interface for use in delivering a flow of breathable gas to an airway of a patient includes a first seal adapted to contact the patient's face and seal a first space between the patient interface and the patient's face at a first positive pressure; and a second seal adapted to contact the patient's face and seal a second space between the patient interface and the patient's face at a second positive pressure. The first seal also seals the first space from the second space. A leak reducing element may be provided on a seal to reduce and/or diffuse leakage of gas. A vacuum line configured to create a negative pressure may be provided in the second space to remove any gas leaking from the first space to the second space. A seal may be connected to a conduit for delivering the flow of gas that is incorporated into a frame of the patient interface. The seal may be inflatable by the flow of breathable gas to pressurize the seal against the patient's face and include a vent that directs the flow of breathable gas to a space between the patient interface and the patient's face. A cuff may be provided over the seal in the nasal bridge region to direct any leakage of the gas flow from the seal in the nasal bridge region in a direction away from the patient's eyes.


