Under-Nose Seal Full-Face Mask With Split Gas Paths

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Solution Overview

Problem

Existing respiratory therapy systems face challenges in effectively flushing anatomical and interface dead space, and there is a need for a user interface that can be used for both Non-Invasive Ventilation (NIV) and High Flow Nasal Therapy (NHF), providing a useful choice for patients and medical professionals.

Innovation Solution

A respiratory user interface featuring a full face mask with an under-nose seal, a breathing gas flow director, and non-sealing nasal prongs that split the gas flow into two paths: one directly to the nares and another to pressurize the mask interior, with vent apertures to continuously flush dead space and provide optimal humidity and pressure support.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If a conventional full face mask is used for NIV therapy, then pressure support is provided to the user's respiratory system, but the mask interior dead space is not effectively flushed leading to CO2 re-breathing

Engineering Contradiction:
Improvepressure support deliveryVSAvoiddead space CO2 re-breathing
Core Design Contradiction:
ReliabilityVSObject-generated harmful factors

Solution Approach 1:

The gas flow director divides the single gas supply into two separate flow paths: one path delivers gas to pressurize the mask interior for NIV therapy, while the other path delivers high flow gas directly to the nasal passages to flush dead space. This segmentation allows simultaneous achievement of pressure support and dead space flushing without compromising either function.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The breathing gas flow director acts as an intermediary device that coordinates between the single gas source and the two distinct therapeutic requirements (pressure support and dead space flushing). It distributes gas appropriately to each pathway, ensuring both NIV pressure delivery and effective dead space ventilation are achieved from a single gas supply.

Inventive Principle:
Principle #24Intermediary (Mediator)

2Object-generated harmful factors

If a nasal cannula is used for NHF therapy, then dead space flushing is improved, but pressure support capability is lost

Engineering Contradiction:
Improvedead space flushingVSAvoidpressure support delivery
Core Design Contradiction:
Object-generated harmful factorsVSReliability

Solution Approach 1:

The invention merges the functionality of a full face mask (for pressure support) with a nasal cannula (for dead space flushing) into a single integrated user interface. The mask portion provides the sealing interface for NIV pressure delivery, while the nasal cannula portion with flow director enables NHF-style dead space flushing, allowing both therapeutic modes to coexist in one device.

Inventive Principle:
Principle #5Merging (Combining)

Solution Approach 2:

The user interface is designed with multi-functionality to accommodate both NIV and NHF therapy requirements. By incorporating both mask and nasal cannula components with an integrated flow director, the device can deliver pressure support through the mask while simultaneously providing dead space flushing through the nasal passages, making it versatile for different therapeutic needs.

Inventive Principle:
Principle #6Universality (Multi-functionality)

3Adaptability or versatility

If a single user interface is designed to provide both NIV and NHF therapy, then versatility is improved, but device complexity increases

Engineering Contradiction:
Improvetherapy mode flexibilityVSAvoidinterface structure
Core Design Contradiction:
Adaptability or versatilityVSDevice complexity

Solution Approach 1:

The nasal cannula and flow director assembly is nested within the mask structure. The flow director is positioned inside the mask interior, and the nasal cannula extends from the mask front, allowing the cannula components to be housed within or attached to the mask body. This nesting arrangement integrates multiple functions into a compact unified structure rather than separate devices.

Inventive Principle:
Principle #7Nested doll (Nesting)

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 interface effectively flushes dead space, delivers optimal humidity and pressure support, and allows for simultaneous NIV and NHF therapy without requiring interface removal, improving patient comfort and treatment efficacy.

Implementation Method 1

a breathing gas flow director configured to split the breathing gas flow into two flow paths, such that a portion of the breathing gas flow is delivered along a first flow path from the inlet into the interior chamber to pressurise the interior chamber, and such that a portion of the breathing gas flow is delivered along a second flow path from the inlet through the nasal prongs

Methodology Applied
Scientific EffectFluid flow splitting:

Implementation Method 2

a portion of the breathing gas flow is delivered along a second flow path from the inlet through the nasal prongs... The nasal prongs are configured to be connected to and project from an outlet end of the breathing gas flow director and are shaped and dimensioned to be received in a user's nares in use without sealing with the nares

Methodology Applied
Scientific EffectGas flushing:

Data Source

PatentEP4201460B1Respiratory user interface
Publication Date: 2025.09.17 FISHER & PAYKEL HEALTHCARE LTD
  • EP4201460B1 patent drawingFigure 1
  • EP4201460B1 patent drawingFigure 2~3
  • EP4201460B1 patent drawingFigure 4a~4d

AI summary

There is provided a user interface (201) comprising an under-nose seal full face mask which comprises: a a mask body (203); b. a mask cushion (205) attached to the mask body and configured to comprise a mouth seal portion (205A) forming a seal around a user's mouth and a nose seal portion (205B) forming a seal around the underside of the user's nose in use;wherein the mask body and mask cushion together define an interior chamber of the user interface; c. a breathing gas delivery inlet (209) provided in the mask body and configured to receive a breathing gas flow from a gas source; d. a pair of non-sealing nasal prongs (223); and e. a breathing gas flow director configured to split the breathing gas flow into two flow paths, such that a portion of the breathing gas flow is delivered along a first flow path (F2) from the inlet into the interior chamber to pressurise the interior chamber, and such that a portion of the breathing gas flow is delivered along a second flow path (F3) from the inlet through the nasal prongs; wherein the nasal prongs are configured to be connected to the breathing gas flow director and are shaped and dimensioned to be received in a user's nares in use.