Air-blasting Surfactant Atomization for Non-invasive Lung Delivery

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Solution Overview

Problem

Current methods for administering pulmonary surfactant to preterm neonates with respiratory distress syndrome are invasive, inefficient, and often result in incomplete lung distribution due to the use of small particle nebulization, which can lead to exhalation and deposition in upper airways, and require mechanical ventilation, increasing the risk of complications.

Innovation Solution

A system comprising a flexible catheter with separate channels for liquid medicament and pressurized gas, connected to pumps and a pressure sensor to atomize the surfactant only during inspiration, ensuring delivery to the lungs without invasive procedures, using an air-blasting technique to produce larger particles that effectively reach alveoli.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of operation

If nebulized surfactant is administered through a mask, then the administration is non-invasive, but the particles are small and may be exhaled or deposited in upper airways, reducing efficacy

Engineering Contradiction:
Improvenon-invasive administrationVSAvoidsurfactant delivery efficacy
Core Design Contradiction:
Ease of operationVSReliability

Solution Approach 1:

The patent changes the particle size parameter by using an atomizer to generate larger particles (SMD >100 μm) compared to conventional nebulization. This parameter change ensures particles are too large to be exhaled during expiration and will deposit in the alveolar region, thereby improving delivery efficacy while maintaining non-invasive administration through a mask.

Inventive Principle:
Principle #35Parameter changes

2Reliability

If mechanical ventilation is used for surfactant administration, then surfactant can be delivered effectively, but the procedure becomes invasive and increases the risk of complications

Engineering Contradiction:
Improvesurfactant delivery efficacyVSAvoidintubation complications
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent extracts the surfactant delivery function from the mechanical ventilation system. By using an atomizer integrated with the ventilator that generates larger particles, the system can deliver surfactant effectively without requiring endotracheal intubation, thereby eliminating the harmful factors associated with invasive mechanical ventilation while maintaining delivery efficacy.

Inventive Principle:
Principle #2Taking out (Extraction)

3Ease of operation

If small nebulized particles are used, then they can pass through upper airways, but they are likely to be exhaled during expiration or deposited in already opened alveoli, failing to reach atelectatic regions

Engineering Contradiction:
Improveparticle deliveryVSAvoidlung distribution homogeneity
Core Design Contradiction:
Ease of operationVSManufacturing precision

Solution Approach 1:

The patent changes the particle size parameter to SMD >100 μm, which fundamentally alters the deposition pattern. Larger particles cannot pass through the upper airways easily and are instead delivered directly to the alveolar region, ensuring homogeneous distribution throughout the lung including atelectatic areas, thereby improving manufacturing precision of lung distribution.

Inventive Principle:
Principle #35Parameter changes

4Device complexity

If surfactant is administered without synchronization to breathing, then delivery is simple, but some surfactant is exhaled during expiration, increasing dead-space and promoting CO2 retention

Engineering Contradiction:
Improveadministration systemVSAvoidCO2 retention
Core Design Contradiction:
Device complexityVSLoss of energy

Solution Approach 1:

The patent implements periodic action by synchronizing surfactant administration with the inspiratory phase of breathing. The atomizer is activated only during inspiration, delivering surfactant at the appropriate time when the airway is open and the lung is expanding. This periodic action prevents surfactant loss during expiration, reduces dead-space, and minimizes CO2 retention while maintaining relatively simple system complexity.

Inventive Principle:
Principle #19Periodic action

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

This method allows for efficient, non-invasive delivery of surfactant to the lungs, reducing mechanical stress and improving lung distribution, while synchronizing with the patient's breathing pattern to minimize waste and ensure effective treatment.

Implementation Method 1

A system for delivering a medicament to spontaneously breathing patients comprises: a flexible catheter adapted to reach the retro-pharyngeal region of the patient, the catheter including at least a first channel being adapted to convey in the patient's pharyngeal region a flow of liquid medicament and at least a second channel adapted to convey in the patient's pharyngeal region a pressurized flow of gas; first pump means connected to a first end of the at least first channel, adapted to create a pressure which pushes the column of liquid medicament towards the second end of the at least first channel; and second pump means connected to a first end of the at least second channel, adapted to create the flow of pressurized gas; so that when the column of liquid medicament and the pressurized gas meet in the pharyngeal cavity, the liquid column is broken into a plurality of particles causing the atomized medicament to be delivered into the patient's lungs

Methodology Applied
Scientific EffectAir-blasting atomization: Fluid Spray

Data Source

PatentUS10456538B2Method and system for the administration of a pulmonary surfactant by atomization
Publication Date: 2019.10.29 CHIESI FARMACEUTICI SPA
  • US10456538B2 patent drawing
  • US10456538B2 patent drawing
  • US10456538B2 patent drawing

AI summary

A method and system according to preferred embodiments of the present invention allows optimizing the dispensing of aerosol medicaments. In particular the system according to a preferred embodiment of the present invention allows the administration of an exogenous pulmonary surfactant to very young patients (e.g. preterm neonates). A catheter 101 conveys atomized surfactant directly to the retro-pharyngeal region in order to increase efficiency of the medicament administration without being invasive: this is particularly important for very young patients, such as pre-term born neonates suffering from neonatal Respiratory Distress Syndrome (nRDS). According to a preferred embodiment of the present invention the catheter is made of biocompatible flexible material (e.g. plastic material). It is possible to couple the catheter with a rigid scaffolding (e.g. metallic) to increase stiffness of the device and to improve easiness of positioning operations. In a preferred embodiment of the present invention the delivery of the atomized medicament is done by means of an air blasting technique.