Patient Interface Seal Zones for PAP Therapy
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Solution Overview
Problem
Current respiratory therapies for disorders such as Obstructive Sleep Apnea, Cheyne-Stokes Respiration, and Chronic Obstructive Pulmonary Disease face challenges with comfort, compliance, and efficacy due to inadequate seal-forming structures and stabilizing mechanisms in patient interfaces, leading to leaks and discomfort, which can disrupt sleep and reduce treatment effectiveness.
Innovation Solution
The development of a patient interface with a seal-forming structure and positioning and stabilizing structure that conforms to the patient's face, using a combination of pressure-assisted sealing mechanisms, compression sealing portions, and flexible materials to maintain a secure seal while minimizing discomfort and improving airflow distribution, along with a complementary flow device that delivers air for additional therapeutic benefits.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a seal-forming structure is used to prevent leaks, then treatment effectiveness is improved, but patient comfort deteriorates due to restricted airflow and pressure buildup
Solution Approach 1:
The seal-forming structure is divided into multiple sealing zones with different characteristics. The first sealing zone uses a first material with specific properties, while the second sealing zone uses a second material with different properties, allowing each zone to address different sealing requirements and airflow needs, thus maintaining effectiveness while improving comfort
Solution Approach 2:
Different portions of the seal-forming structure have different material properties and functions. The first sealing zone is optimized for one aspect of sealing, while the second sealing zone is optimized for another aspect, creating local variations in material composition and structure that balance sealing performance with patient comfort
2Reliability
If a rigid patient interface is used to maintain seal, then sealing reliability is improved, but adaptability to different face shapes deteriorates
Solution Approach 1:
The patient interface incorporates materials with varying degrees of rigidity and flexibility. By changing the material parameters - using more rigid materials in areas requiring structural support and more flexible materials in areas requiring conformability - the interface can maintain sealing reliability while adapting to different face shapes and sizes
3Reliability
If high pressure is applied to form seal, then sealing effectiveness is improved, but patient comfort deteriorates due to increased pressure on face
Solution Approach 1:
The seal-forming structure employs different materials in different zones, where certain areas are designed to distribute pressure more evenly while other areas provide focused sealing. This local differentiation allows the interface to achieve effective sealing without concentrating excessive pressure on any single area of the patient's face
Solution Approach 2:
The patient interface uses composite materials combining rigid and flexible components, or materials with different pressure-distribution characteristics. This composite construction enables the interface to maintain sealing effectiveness while reducing peak pressures and improving overall comfort
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 improved patient interface enhances treatment compliance and efficacy by reducing leaks, increasing comfort, and providing additional therapeutic benefits through targeted airflow, thereby improving respiratory therapy outcomes for patients with sleep-related disorders.
Implementation Method 1
pressure-assisted sealing mechanisms
Implementation Method 2
compression sealing portions
Implementation Method 3
flexible materials
Data Source
AI summary
Disclosed is an apparatus for delivery of pressurised air or breathable gas to a patient. The apparatus may comprise a flow generator configured to generate a flow of air. A patient interface may be constructed and arranged to form a seal with a region of the patient's face surrounding an entrance to the patient's airways. The patient interface may be configured to deliver the pressurised air or breathable gas to the patient's airways for respiratory therapy. An air delivery tube may be coupled between the flow generator and the patient interface to deliver the flow of air from the flow generator to the patient interface as the pressurised air or breathable gas. A complementary flow device may be configured to divert at least part of the pressurised air or breathable gas away from the patient's airway.