Aerosol Delivery Device Gasket Compression Control

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Solution Overview

Problem

Aerosol delivery devices face challenges in achieving consistent particle size for effective drug delivery, as variations in particle size can lead to inadequate efficacy or side effects due to uneven drug distribution in the bloodstream and lungs.

Innovation Solution

An adjustable aerosol delivery device with a piezo disc and gasket system that alters the compression of a flexible gasket to control the particle size of aerosol particles, allowing for precise adjustment of the aerosol particle size by manipulating the gasket's compression, which affects the energy distribution and resonant frequency, thereby optimizing the delivery of active substances like treprostinil.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Length of moving object

If particle size is increased to improve drug delivery depth, then particles can reach deeper into lung tissue, but particles become too large to be effectively deposited and absorbed

Engineering Contradiction:
Improveparticle sizeVSAvoiddrug deposition efficiency
Core Design Contradiction:
Length of moving objectVSReliability

Solution Approach 1:

The patent applies parameter changes by systematically varying the particle size of the aerosol formulation to optimize drug delivery. The invention identifies a specific particle size range (0.5-5 micrometers) that balances deep lung penetration with effective deposition and absorption, transforming the liquid active substance into aerosol particles within this critical size window through controlled atomization processes.

Inventive Principle:
Principle #35Parameter changes

2Length of moving object

If particle size is decreased to improve deposition and absorption, then particles can be effectively deposited in lungs, but particles may be exhaled before being deposited and absorbed

Engineering Contradiction:
Improveparticle sizeVSAvoiddrug delivery effectiveness
Core Design Contradiction:
Length of moving objectVSProductivity

Solution Approach 1:

The patent utilizes parameter changes by establishing a lower bound for particle size (0.5 micrometers) to prevent particles from being too small and exhaled before deposition. This parameter optimization ensures that particles remain within the lung airspace long enough to be deposited and absorbed effectively, while still being small enough to reach deep into lung tissue.

Inventive Principle:
Principle #35Parameter changes

3Ease of operation

If aerosol particle size varies, then device operation is simplified, but exact dosage of active substance delivered to user becomes inconsistent

Engineering Contradiction:
Improveaerosol generationVSAvoiddosage accuracy
Core Design Contradiction:
Ease of operationVSManufacturing precision

Solution Approach 1:

The patent applies parameter changes by controlling the atomization process to produce aerosol particles within a specific size range (0.5-5 micrometers). This parameter control ensures consistent dosing of the active substance by maintaining uniform particle sizes that deposit predictably in the lungs, thereby achieving both ease of operation and dosage accuracy.

Inventive Principle:
Principle #35Parameter changes

4Quantity of substance

If too little drug is present in bloodstream to achieve therapeutic concentration, then side effects are minimized, but efficacy is inadequate

Engineering Contradiction:
Improvedrug concentration in bloodstreamVSAvoidtherapeutic efficacy
Core Design Contradiction:
Quantity of substanceVSReliability

Solution Approach 1:

The patent applies parameter changes by optimizing aerosol particle size to ensure efficient lung deposition and rapid transfer to the bloodstream. The controlled particle size (0.5-5 micrometers) maximizes the surface area to volume ratio, enhancing absorption efficiency and achieving therapeutic blood concentrations reliably without requiring excessive drug doses, thus avoiding side effects.

Inventive Principle:
Principle #35Parameter changes

5Quantity of substance

If too much drug is present in bloodstream, then efficacy is maximized, but side effects occur

Engineering Contradiction:
Improvedrug concentration in bloodstreamVSAvoidside effects
Core Design Contradiction:
Quantity of substanceVSObject-generated harmful factors

Solution Approach 1:

The patent applies parameter changes by precisely controlling aerosol particle size to optimize absorption kinetics. The specific particle size range (0.5-5 micrometers) ensures that the drug is delivered at a controlled rate, achieving therapeutic concentrations without overshooting into toxic ranges. This parameter optimization allows for effective drug delivery while maintaining safety margins.

Inventive Principle:
Principle #35Parameter changes

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 achieves precise control over aerosol particle size, ensuring consistent and effective delivery of pharmaceuticals, maintaining therapeutic window concentrations while minimizing side effects by adjusting the gasket compression to alter the energy focal point and mechanical load on the piezo disc.

Implementation Method 1

providing a piezo disc (230) within a piezo disc housing (250)... an oscillator (240) configured to generate an ultrasonic wave that causes the piezo disc (230) to vibrate

Methodology Applied
Scientific EffectPiezoelectric effect: Piezoelectric Effect

Implementation Method 2

an oscillator (240) configured to generate an ultrasonic wave that causes the piezo disc (230) to vibrate and transmit the oscillations through the carrier liquid to the active liquid

Methodology Applied
Scientific EffectUltrasonic vibration: Ultrasonic Vibration

Implementation Method 3

manipulating a compression of the gasket (260) to alter a particle size of the active substance produced by the aerosol delivery device... altering the compression of the flexible gasket to control the particle size of aerosol particles, allowing for precise adjustment of the aerosol particle size by manipulating the gasket's compression, which affects the energy distribution and resonant frequency

Methodology Applied
Scientific EffectResonance: Resonance

Data Source

PatentEP3565621B1Aerosol delivery device and method for manufacturing and operating the same
Publication Date: 2021.09.01 UNITED THERAPEUTICS CORP
  • EP3565621B1 patent drawingFigure 1~2
  • EP3565621B1 patent drawingFigure 3
  • EP3565621B1 patent drawingFigure 4A~4C

AI summary

An adjustable aerosol delivery device includes an active liquid container, a carrier liquid container, a piezo disc mounted with a flexible gasket relative to the carrier liquid container, an oscillator configured to generate an ultrasonic wave that causes the piezo disc to oscillate and transmit the oscillations through the carrier liquid to the active liquid to cause at least a portion of the active liquid to become an aerosol, a bushing fixed relative to the carrier liquid container via a fixing portion that conforms to and mates with an entire perimeter of a fixing section of the bushing, and a fastener extending through the piezo disc housing and into the bushing. The fastener is configured to be loosened or tightened to manipulate a compression of the gasket to adjust a particle size of the aerosol. A pull force of the bushing is greater than a counter force of the gasket.