Unobtrusive Patient Interface System for Sleep Apnea Therapy
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Solution Overview
Problem
Current patient interface systems for delivering breathable gas, such as those used in treating sleep disordered breathing, are often obtrusive, making them uncomfortable for patients and leading to treatment resistance, especially for mild cases where a seal is not necessary or difficult to maintain.
Innovation Solution
The development of a patient interface system that includes a cannula with non-sealing nasal prongs and adjustable positioning structures, such as straps and clips, to deliver breathable gas in a less obtrusive manner, allowing for comfortable use without forming a seal with the patient's airways, and incorporating features like foam gaskets and vented cannulae to reduce noise and improve comfort.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a mask interface that forms a seal with the patient's airways is used to deliver breathable gas, then the prescribed pressure can be maintained, but the patient finds it difficult to sleep in familiar positions and the treatment becomes obtrusive
Solution Approach 1:
The patient interface is segmented into separate functional components: a headgear system for positioning and a minimal-contact interface element (such as a nasal pillow or small cushion) for gas delivery. This segmentation allows the interface to maintain pressure reliability through proper sealing at the nose while eliminating the need for extensive face coverage, thereby improving comfort during sleep in various positions.
Solution Approach 2:
The invention extracts the essential sealing function from the traditional full-face mask and relocates it to a minimal-contact interface element positioned only at the nose. This extraction removes the obtrusive headgear and large cushion components, allowing patients to sleep in familiar positions while maintaining the necessary seal for pressure delivery through the simplified nasal interface.
2Ease of operation
If a nasal cannula with small diameter is used to deliver breathable gas, then the device is less obtrusive, but significant pressure drop occurs requiring the compressor to generate excess pressure
Solution Approach 1:
The invention applies local quality by providing a larger diameter interface element specifically at the nose (where the seal is formed) while maintaining smaller cannula portions for gas delivery. This localized enlargement at the critical sealing point reduces pressure drop without compromising the minimal-contact, comfortable design of the overall system.
Solution Approach 2:
The interface system incorporates dynamic elements such as adjustable headgear straps and flexible positioning mechanisms that allow the interface to adapt to different patient positions and facial contours. This dynamic adjustment capability maintains optimal seal quality and minimizes pressure drop regardless of the patient's sleeping position, while preserving the comfortable, less-obtrusive design.
3Object-affected harmful factors
If the air compressor is located in an adjacent room to reduce noise, then the sleeping person is not disturbed, but the person cannot operate the turbine regulator
Solution Approach 1:
The invention introduces an intermediary control mechanism that allows the turbine regulator to be operated remotely or automatically. The intermediary system (such as wireless controls, automated pressure regulation, or remote monitoring capabilities) enables the compressor to be positioned in an adjacent room to eliminate noise disturbance while maintaining the ability to operate and adjust the turbine regulator without direct physical access.
4Reliability
If a seal is formed with the patient's airways using a mask, then the prescribed pressure can be delivered, but the patient may abandon the treatment due to discomfort
Solution Approach 1:
The invention inverts the traditional approach by starting with the comfort requirement and designing the interface to minimize contact and obtrusiveness, then incorporating the necessary sealing function into this simplified structure. Rather than adding comfort features to a traditional mask, the design begins with a minimal interface (such as nasal pillows) and ensures pressure delivery reliability through precise sealing at the nose, thereby achieving both compliance and effectiveness.
Data Source
AI summary
A patient interface assembly includes a flexible cushion configured to sealingly engage the patient's nares and a frame with a pair of flexible extending members that extend laterally from opposite sides of the frame. The frame and the flexible cushion together form a chamber. The patient interface assembly also includes a positioning and stabilising structure configured to maintain the flexible cushion in engagement with the patient's nares. The positioning and stabilizing structure has a pair of headgear straps. Each headgear strap is connected to a respective one of the flexible extending members. The flexible extending members do not form an airflow path for the breathable gas. The headgear straps have a multi-layered structure, at least one layer being made of fabric and at least one layer being made of plastic. In addition, the at least one plastic layer is a rigidizer that adds rigidity to the respective headgear strap.