Variable Resistance Expiratory Valve for Sleep Apnea

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Solution Overview

Problem

Current treatments for obstructive sleep apnea (OSA) and snoring, such as CPAP systems and ProventĀ® Sleep Apnea Therapy, face challenges including poor patient compliance due to discomfort, high airflow rates, and ineffectiveness in mouth breathers, with a need for more comfortable and effective solutions that provide continuous airway pressure during both inhalation and exhalation.

Innovation Solution

A system comprising a mask with a one-way, variable resistance expiratory valve that adjusts resistance over the expiratory phase, a portable air flow generator providing low flow rates (1-20 liters per minute), and a design that eliminates the need for high flow rates, allowing for a more comfortable and effective treatment of OSA and snoring by maintaining airway pressure throughout the breathing cycle.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If CPAP systems provide high airflow rates to compensate for mask leaks, then airway pressure is maintained, but patient discomfort increases and compliance decreases

Engineering Contradiction:
Improveairway pressure maintenanceVSAvoidpatient compliance
Core Design Contradiction:
ReliabilityVSEase of operation

Solution Approach 1:

The expiratory valve incorporates a feedback mechanism where the valve opening degree automatically adjusts based on the detected airway pressure. When pressure drops (indicating potential leakage), the valve opens wider to maintain pressure. When pressure is sufficient, the valve closes more to reduce airflow resistance. This closed-loop feedback eliminates the need for high continuous airflow rates while maintaining therapeutic pressure, thereby improving patient comfort and compliance.

Inventive Principle:
Principle #23Feedback

Solution Approach 2:

The expiratory valve transitions from a static fixed-orifice design to a dynamic variable-orifice design. The valve opening degree changes continuously during the expiratory phase based on real-time pressure conditions, allowing the system to adapt to varying breathing patterns and leakage rates without requiring high airflow compensation.

Inventive Principle:
Principle #15Dynamics

2Device complexity

If fixed orifice resistors are used to provide expiratory resistance, then device simplicity is maintained, but pressure control precision deteriorates

Engineering Contradiction:
Improvevalve structure simplicityVSAvoidpressure control precision
Core Design Contradiction:
Device complexityVSMeasurement precision

Solution Approach 1:

The expiratory valve employs a dynamic opening mechanism where the valve aperture automatically adjusts during expiration based on pressure feedback. This dynamic adjustment enables precise pressure control throughout the expiratory phase, overcoming the fixed-orifice limitation while maintaining relatively simple valve construction using elastic membranes or shape memory alloys.

Inventive Principle:
Principle #15Dynamics

Solution Approach 2:

The valve utilizes material property changes (elastic deformation of membranes or phase transition of shape memory alloys) to dynamically alter the opening degree parameter in response to pressure changes, achieving precise pressure control without complex mechanical actuation systems.

Inventive Principle:
Principle #35Parameter changes

3Reliability

If expiratory resistance is increased to maintain airway pressure, then positive pressure is achieved, but exhalation discomfort increases

Engineering Contradiction:
Improveairway pressureVSAvoidexhalation discomfort
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The expiratory valve provides time-varying resistance during the expiratory phase by dynamically adjusting its opening degree. Early in expiration when airflow is high, the valve opens wider to reduce resistance and discomfort. As expiration progresses and airflow decreases, the valve gradually closes to maintain airway pressure. This dynamic adaptation eliminates the constant high resistance of fixed-orifice devices while achieving therapeutic pressure maintenance.

Inventive Principle:
Principle #15Dynamics

Solution Approach 2:

The valve operation follows a periodic pattern synchronized with the breathing cycle, providing low resistance during high-flow periods and high resistance during low-flow periods, optimizing both comfort and therapeutic effect throughout the expiratory phase.

Inventive Principle:
Principle #19Periodic action

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 system improves patient compliance and treatment efficacy by reducing discomfort, maintaining airway pressure, and being effective for both nasal and mouth breathers, while being more compact and less cumbersome than traditional CPAP systems.

Implementation Method 1

providing a first amount of resistance to expiration during an early portion of an expiratory phase of breathing and providing a second, greater amount of resistance to expiration during a later portion of the expiratory phase

Methodology Applied
Scientific EffectVariable resistance valve mechanism:

Implementation Method 2

providing positive airflow into an airway of the patient during the early portion and providing a second, greater amount of positive airflow into the airway during the later portion

Methodology Applied
Scientific EffectPositive airway pressure generation:

Data Source

PatentEP2996753B1Auto-feedback valve for a sleep apnea device
Publication Date: 2019.12.11 FRESCA MEDICAL INC
  • EP2996753B1 patent drawingFigure 1A~1B
  • EP2996753B1 patent drawingFigure 2
  • EP2996753B1 patent drawingFigure 3A

AI summary

A device (1500) for treating a patient suffering from obstructive sleep apnea or snoring can include an expiratory valve (1502) connected to a manifold. The expiratory valve can include a body portion including a feedback port (1518) configured to be connected to an air flow generator. The expiratory valve can include a plunger (1504) at least partially disposed in the body portion. The expiratory valve can include a pressurizing chamber (1516) positioned between an end of the plunger and an end of the expiratory valve. The pressurizing chamber can be configured to receive air from the air flow generator through the feedback port.