Variable Resistance Expiratory Valve for Sleep Apnea

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Solution Overview

Problem

Current treatments for obstructive sleep apnea (OSA), such as CPAP systems, are cumbersome, uncomfortable, and have low user compliance due to high airflow rates, nasal dryness, and noise, while alternative methods like Provent therapy are ineffective for mouth breathers and lack a 'rescue pressure' during apneic events.

Innovation Solution

A novel valve structure connected to an air flow generator and a mask that covers the nostrils, featuring an inlet pressure port and an expiratory valve with a membrane that forms seals with primary and secondary seats, allowing variable opening pressure based on inlet pressure, and an inspiration valve for easy airflow from outside the mask, reducing the need for high airflow rates and enhancing user comfort.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Stress or pressure

If high airflow rates are used in CPAP systems to maintain airway pressure, then airway pressure is maintained, but user comfort deteriorates due to nasal dryness and discomfort

Engineering Contradiction:
Improveairway pressureVSAvoidnasal dryness and discomfort
Core Design Contradiction:
Stress or pressureVSObject-affected harmful factors

Solution Approach 1:

The valve structure dynamically adjusts airflow resistance based on breathing phase. During inspiration, the valve opens to allow high airflow rates to maintain airway pressure. During expiration, the valve closes to reduce airflow resistance, preventing nasal dryness and discomfort. This dynamic adjustment resolves the contradiction between maintaining airway pressure and avoiding harmful side effects.

Inventive Principle:
Principle #15Dynamics

Solution Approach 2:

The system changes the parameter of airflow resistance throughout the breathing cycle. By varying resistance from low during inspiration to high during expiration, the system maintains effective airway pressure while reducing the harmful effects of continuous high airflow rates, such as nasal dryness.

Inventive Principle:
Principle #35Parameter changes

2Stress or pressure

If high airflow rates are used in CPAP systems, then airway pressure is maintained, but device complexity and noise increase

Engineering Contradiction:
Improveairway pressureVSAvoiddevice complexity and noise
Core Design Contradiction:
Stress or pressureVSDevice complexity

Solution Approach 1:

The valve structure is a passive, self-regulating component that automatically adjusts airflow resistance based on pressure differential without requiring external control systems. The valve opens when inspiratory pressure exceeds expiratory pressure and closes when expiratory pressure exceeds inspiratory pressure, eliminating the need for complex electronic controls and reducing device complexity and noise.

Inventive Principle:
Principle #25Self-service

Solution Approach 2:

The system uses pneumatic principles to control valve operation. The valve responds to pressure differences between inspiration and expiration phases, using the breathing itself to drive the valve mechanism. This pneumatic control system is simpler and quieter than electronic control systems while effectively maintaining airway pressure.

Inventive Principle:
Principle #29Pneumatics and hydraulics

3Device complexity

If alternative methods like Provent therapy are used, then device complexity is reduced, but effectiveness deteriorates for mouth breathers and during apneic events

Engineering Contradiction:
Improvedevice complexityVSAvoideffectiveness for mouth breathers and during apneic events
Core Design Contradiction:
Device complexityVSReliability

Solution Approach 1:

The valve structure is designed to work with both nasal and oral breathing pathways. It can be integrated into masks that cover either the nose or both nose and mouth, making it effective for different breathing patterns. Additionally, the valve provides active pressure support during apneic events by maintaining resistance, unlike passive alternatives such as Provent therapy.

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

Solution Approach 2:

The valve structure is pre-configured to provide immediate pressure support during apneic events. The resilient member is pre-loaded to maintain a baseline resistance that automatically increases during apnea, providing rescue pressure without requiring detection algorithms or active control, unlike some electronic systems.

Inventive Principle:
Principle #10Preliminary action

4Device complexity

If simple valve structures are used, then device complexity is reduced, but ability to provide rescue pressure during apnea deteriorates

Engineering Contradiction:
Improvedevice complexityVSAvoidrescue pressure during apnea
Core Design Contradiction:
Device complexityVSReliability

Solution Approach 1:

The valve structure dynamically adjusts resistance based on the breathing phase and apnea detection. During normal breathing, the valve provides baseline resistance. During apnea, the valve maintains higher resistance to provide rescue pressure. This dynamic behavior is achieved through the interaction of the resilient member and pressure differential, not complex electronics.

Inventive Principle:
Principle #15Dynamics

Solution Approach 2:

The valve uses pneumatic principles to provide automatic rescue pressure during apnea. The resilient member maintains a spring-loaded resistance that prevents complete valve closure during apneic events, ensuring continuous pressure support. This passive pneumatic mechanism provides reliable rescue pressure without complex control systems.

Inventive Principle:
Principle #29Pneumatics and hydraulics

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 valve structure provides a more comfortable and effective treatment for OSA by reducing airflow resistance, maintaining airway pressure, and allowing for easier breathing, with improved user compliance and reduced side effects compared to traditional CPAP systems.

Implementation Method 1

the opening pressure of the expiratory valve increases when the pressure of air in the inlet pressure port increases; and/or (2) the opening pressure of the expiratory valve decreases when the pressure of air in the inlet pressure port decreases

Methodology Applied
Scientific EffectPressure differential: Pressure Gradient

Implementation Method 2

an inspiratory valve constructed to allow air flow from the outside of the mask into the mask with little resistance

Methodology Applied
Scientific EffectPressure gradient: Pressure Gradient

Implementation Method 3

an expiratory valve constructed to allow air flow from within the mask to the outside of the mask with a resistance to air flow that varies based on the pressure of air in the inlet pressure port

Methodology Applied
Scientific EffectPressure differential: Pressure Gradient

Data Source

PatentUS11253672B2Sleep apnea treatment system and improvements thereto
Publication Date: 2022.02.22 FRESCA MEDICAL INC
  • US11253672B2 patent drawing
  • US11253672B2 patent drawing
  • US11253672B2 patent drawing

AI summary

A valve structure for treating a patient suffering from obstructive sleep apnea is provided. The valve structure is connected to an air flow generator and is connected to a mask that covers at least the nostrils of a patient. The valve structure includes an inlet pressure port attached to the air flow generator and an expiration valve that includes an expiratory membrane, a primary seat and a secondary seat. During inspiration, the expiratory membrane forms a seal with the primary seat, and during expiration, the expiratory membrane forms a seal with the secondary seat.