Toroidal Nasal Device for EPAP Generation
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Solution Overview
Problem
Current nasal devices for treating sleep apnea-hypopnea syndrome, particularly CPAP-based treatments, are often uncomfortable and poorly tolerated due to side effects such as stomach swelling, headaches, mucous membrane irritation, diaphragm weakening, and limited positional flexibility, affecting around 50% of patients, and existing devices lack mechanical responsiveness and require a power source.
Innovation Solution
A toroidal nasal device with a flexible, ring-shaped structure that separates nasal tissues and optionally creates expiratory positive airway pressure (EPAP) using airflow resistances, allowing for comfortable, power-free use and adaptation to various nasal anatomies, while maintaining mechanical responsiveness and ease of installation and removal.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If CPAP-based treatments are used to create positive airway pressure, then airway expansion and breathing improvement are achieved, but patient comfort deteriorates due to side effects such as stomach swelling, headaches, and mucous membrane irritation
Solution Approach 1:
The device segments the air pressure generation function from the traditional CPAP system by using separate airflow resistance elements positioned at different locations within the nasal cavity. This segmentation allows targeted pressure generation without the need for full-face masks and continuous high-pressure air delivery, thereby reducing side effects while maintaining treatment efficacy.
Solution Approach 2:
The patent introduces airflow resistance elements as intermediary components that passively generate positive airway pressure through the natural breathing process. These resistance elements act as mediators between the patient's breathing effort and the airway, creating EPAP without requiring external power sources or complex mask systems, thus improving comfort while maintaining reliability.
2Reliability
If standard CPAP devices with power sources are used, then positive airway pressure is generated effectively, but device complexity and portability deteriorate due to the need for electrical power supply
Solution Approach 1:
The device employs self-service mechanisms where the patient's own breathing effort drives the airflow through resistance elements, automatically generating the required positive airway pressure. The spring-loaded closure elements and airflow resistance structures are activated passively by inhalation and exhalation forces, eliminating the need for external power sources, batteries, or electrical components, thereby simplifying the device while maintaining effective pressure generation.
Solution Approach 2:
The patent replaces the electrical-mechanical system of traditional CPAP devices (motors, pumps, power supplies) with a purely passive mechanical system based on spring-loaded closure elements and airflow resistance. This mechanical substitution eliminates complex electrical components and power requirements while maintaining the core function of generating positive airway pressure through the natural breathing cycle.
3Adaptability or versatility
If nasal devices are designed to fit various nasal anatomies, then adaptability improves, but device stability and positioning accuracy deteriorate
Solution Approach 1:
The device incorporates dynamic elements including spring-loaded closure components that can adjust their position and force based on the specific nasal anatomy encountered. The elastic elements allow the device to adapt to varying nasal cavity dimensions and shapes while maintaining stable positioning through controlled elastic forces that self-regulate according to the anatomical constraints of each patient.
Solution Approach 2:
The patent utilizes parameter changes in the elastic properties and geometric configuration of the closure elements to achieve both adaptability and stability. By designing springs and elastic components with specific force constants and geometric parameters, the device can accommodate a range of nasal anatomies while maintaining sufficient stabilizing forces for reliable positioning during use.
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 toroidal nasal device improves nasal airflow by separating tissues and generating EPAP, enhancing breathing comfort and efficiency without the need for a power source, addressing the limitations of existing devices and improving user tolerance and treatment efficacy.
Implementation Method 1
a flexible toroidal structure, suitable to be introduced partially into the subject's nasal cavities
Implementation Method 2
devices which create positive airway pressure using airflow resistances located in the upper airways, which resist the exit of air during the expiratory phase
Data Source
Figure 1~3
Figure 4a~4c
Figure 5a~6b
AI summary
The present invention relates to a nasal device for modifying the nasal airflow comprising a flexible toroidal structure (1), suitable to be inserted into the subject's nasal cavities, separating the tissues of the nasal anatomy. The device comprises a closing element (2) connected to the toroidal structure (1), equipped with means to alter the shape of said toroidal structure (1), causing it to adopt a new form comprising at least two lobes (1', 1"), each of which can be inserted into a subject's nasal cavity. When the device is inserted into the subject's nasal cavities, the closing element (2) is arranged in the lower external region of the nose between the two nostrils, and each of the lobes (1', 1") of the toroidal structure (1) presses against the inner surface of the nasal cavities.