Nasal Prong Bellows Segmentation for CPAP Seal

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Solution Overview

Problem

Conventional nasal interface prong devices for CPAP systems in infants face challenges such as discomfort due to immobile prongs causing pressure points, potential tissue damage, and the need for multiple sizes to accommodate varying nasal anatomies, especially in premature infants, due to lack of flexibility and inadequate self-correction for nasal diameter variations.

Innovation Solution

A nasal interface prong device with flexible bellows segments and tips that pivot relative to the base, allowing for radial movement and accommodating misalignments, featuring a reduced wall thickness at the tip for comfort and a curved design to conform to nasal anatomy, with a non-symmetrical bellows segment configuration to reduce pressure points and accommodate septal deviations.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If the prong is made soft to achieve fluid seal, then the seal is improved, but the prong may kink during use

Engineering Contradiction:
Improvefluid sealVSAvoidprong structure
Core Design Contradiction:
ReliabilityVSStability of the object's composition

Solution Approach 1:

The prong is divided into two distinct segments: a soft tip portion for sealing and a rigid shaft portion for structural stability. The soft tip portion can be made of elastomeric material to achieve fluid seal, while the rigid shaft portion maintains structural integrity and prevents kinking during use.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

Different portions of the prong have different mechanical properties. The tip portion is soft and compliant to accommodate nasal tissue and maintain seal, while the shaft portion is rigid to provide structural support and prevent deformation. This local differentiation resolves the contradiction between seal quality and structural stability.

Inventive Principle:
Principle #3Local quality

2Stability of the object's composition

If the prong is made rigid to maintain structure, then the stability is improved, but pressure points cause discomfort and tissue damage

Engineering Contradiction:
Improveprong structureVSAvoidpressure points
Core Design Contradiction:
Stability of the object's compositionVSObject-affected harmful factors

Solution Approach 1:

The prong is segmented into a rigid shaft portion that maintains structural stability and a soft tip portion that distributes pressure. The rigid shaft provides structural support while the soft tip prevents pressure point formation through its compliant nature.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The prong exhibits local quality differentiation where the shaft portion is rigid for structural stability and the tip portion is soft for comfort. This local property variation allows the prong to maintain overall structure while eliminating harmful pressure points at the tissue interface.

Inventive Principle:
Principle #3Local quality

3Adaptability or versatility

If the prong is made flexible to accommodate misalignment, then the adaptability is improved, but the prong may collapse during insertion

Engineering Contradiction:
Improvemisalignment accommodationVSAvoidprong structural strength
Core Design Contradiction:
Adaptability or versatilityVSStrength

Solution Approach 1:

The prong is divided into a flexible tip portion that can pivot and adapt to misalignment, and a rigid shaft portion that maintains structural strength. The flexible tip allows the prong to accommodate varying nasal anatomy while the rigid shaft prevents collapse during insertion and use.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The prong has local quality differentiation where the tip portion is flexible to accommodate misalignment and the shaft portion is rigid to maintain structural strength. This local property variation enables the prong to adapt to anatomical variations without collapsing.

Inventive Principle:
Principle #3Local quality

4Adaptability or versatility

If multiple sizes of prongs are used to accommodate varying nasal anatomies, then the adaptability is improved, but the device complexity and inventory requirements increase

Engineering Contradiction:
Improvenasal anatomy accommodationVSAvoidinventory requirements
Core Design Contradiction:
Adaptability or versatilityVSDevice complexity

Solution Approach 1:

The prong incorporates a flexible, movable tip portion that can dynamically adjust its position and orientation to accommodate varying nasal anatomies. This dynamic adaptability eliminates the need for multiple fixed sizes, as a single prong design can adapt to different patient anatomies through the flexible tip's movement.

Inventive Principle:
Principle #15Dynamics

Solution Approach 2:

The prong is designed with universal adaptability through its flexible tip portion that can accommodate various nasal diameters and anatomical variations. A single prong design serves multiple patients with different anatomies, eliminating the need for multiple specialized sizes and reducing inventory requirements.

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

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 device provides a comfortable and secure seal with reduced risk of pressure sores, accommodates anatomical variations, and allows for easy alignment of the CPAP generator, minimizing the need for multiple sizes and enhancing patient comfort and safety.

Implementation Method 1

Each prong includes a bellows segment, a tip, and a lumen... the bellows segment renders the corresponding prong highly flexible such that the respective tips radially pivot relative to the base

Methodology Applied
Scientific EffectFlexible deformation: Elasticity

Data Source

PatentEP3150246B1Nasal interface prong device
Publication Date: 2018.10.31 VYAIRE MEDICAL CONSUMABLES LLC
  • EP3150246B1 patent drawingFigure 1
  • EP3150246B1 patent drawingFigure 2A~2B
  • EP3150246B1 patent drawingFigure 2C

AI summary

A nasal interface device (20) comprising: first and second nasal prongs (22,24); and a base (26) connected to each of first and second nasal prongs (22, 24) by means of a first passage (72) and a second passage (74) respectively, each defining a passage axis (P), the first and second nasal prongs (22,24) each including: a bellows segment (42), a tip (40) having a tip body (48) extending from the bellows segment (42) and terminating in a tip end (46) opposite the bellows segment, a foot (44) extending from the base (26) to the bellows segment (42); and a lumen (28, 30) extending through the prong and open at the tip end, wherein in an undeflected state, a central axis (Abellows) of the lumen as defined by the bellows segment (42) is transversely offset from a central axis (Atip) of the lumen as defined by the tip end (46), and, relative to the passage axis (P), a central axis (Afoot) of the foot (44) projects laterally outwardly with proximal extension of the foot (44) from the base (26).