Patient Interface Headgear With Cheek Supports for Stable Nasal Sealing
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Solution Overview
Problem
Existing patient interfaces for respiratory therapy, such as CPAP and NIPPV, often suffer from poor fit, discomfort, and instability, particularly when used for extended periods, and fail to accommodate diverse facial shapes and movements.
Innovation Solution
A patient interface with dual-walled nasal pillows, a semi-rigid frame, and adjustable headgear features, including cheek supports and flexible straps, to enhance seal, comfort, and stability, allowing for a wide range of facial fits and minimizing disruptions.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Stability of the object's composition
If a rigid or semi-rigid frame is used to provide structural support, then stability is improved, but comfort deteriorates due to pressure points and lack of flexibility
Solution Approach 1:
The frame is divided into multiple zones with different rigidity characteristics. The nasal pillow area uses softer materials for comfort, while the rear and side portions use more rigid materials for stability. This segmentation allows each region to perform its specific function optimally without compromising the other.
Solution Approach 2:
Different portions of the frame have locally optimized properties: the nasal pillow portion is soft and compliant for patient comfort, while the rear headgear portion is rigid for stable positioning. This local quality differentiation resolves the contradiction between overall stability and local comfort.
2Reliability
If headgear straps are tightened to improve seal, then seal quality is improved, but comfort deteriorates due to excessive pressure and cheek marks
Solution Approach 1:
The nasal pillows are pre-formed with a shape that naturally conforms to the nasal cavity geometry. This preliminary shaping allows the pillows to create an effective seal through their inherent form rather than requiring excessive tightening of headgear straps, thereby maintaining comfort while achieving reliable sealing.
Solution Approach 2:
The nasal pillows are designed as replaceable, disposable components that can be easily replaced when worn. This allows patients to use fresh pillows that maintain optimal sealing characteristics without the degradation that would require increasing strap tension over time, thus avoiding comfort issues.
3Adaptability or versatility
If the mask system is designed to fit diverse facial shapes, then adaptability is improved, but device complexity increases due to multiple adjustment mechanisms
Solution Approach 1:
The headgear system is designed as a universal assembly that can accommodate various facial shapes and sizes through a standardized set of adjustment mechanisms. The same basic structure serves multiple functions: adjusting strap length, positioning the nasal pillows, and securing the frame, thereby achieving high adaptability without proportionally increasing complexity.
Solution Approach 2:
The headgear incorporates dynamic adjustment capabilities allowing patients to easily modify the fit throughout the day as needed. The adjustment mechanisms are designed to be simple and accessible, enabling quick changes to accommodate different sleeping positions or facial swelling without complex procedures.
4Object-affected harmful factors
If nasal pillows are made softer to improve comfort, then comfort is improved, but seal reliability deteriorates due to insufficient support
Solution Approach 1:
The nasal pillows are constructed using composite material structures combining soft outer layers for comfort with slightly more rigid inner structures or support elements. This composite construction allows the pillows to remain soft and comfortable against the patient's skin while maintaining sufficient structural integrity to form a reliable seal.
Solution Approach 2:
The nasal pillows are pre-formed during manufacturing with an optimized geometry that inherently provides sealing support. This preliminary shaping compensates for the softness of the material, allowing the pillows to maintain their sealing function without requiring excessive rigidity that would compromise comfort.
Data Source
AI summary
A patient interface for delivering breathable gas to a patient includes a nasal prong assembly including a pair of nasal prongs structured to sealingly communicate with nasal passages of a patient's nose in use and headgear to maintain the nasal prong assembly in a desired position on the patient's face. The headgear includes side straps and rigidizers provided to respective side straps. Each rigidizer includes a first end portion that provides a connector structured to engage a respective end of the nasal prong assembly and an inwardly curved protrusion in the form of a cheek support that curves inwardly of the connector. The cheek support is adapted to follow the contour of the patient's cheek and guide a respective end portion of the side strap into engagement with the patient's cheek to provide a stable cheek support.