Breath-Synchronized Surfactant Nebulizer for Preterm Infants

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Solution Overview

Problem

Current methods for administering pulmonary surfactant to preterm infants with respiratory distress syndrome, such as bolus administration, are invasive and associated with side effects, and alternative approaches like nebulization have shown poor surfactant deposition due to technical issues like high hydraulic resistance and compliance in delivery systems, leading to delayed and inefficient delivery.

Innovation Solution

A system that uses a pressure sensor to synchronize surfactant delivery with the patient's inspiratory phase, employing a microprocessor to adjust the infusion pump's flow and gas flow to atomize the surfactant effectively, reducing rising and falling times and improving surfactant deposition in the lungs.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If bolus administration is used to deliver pulmonary surfactant, then the surfactant delivery is effective, but the procedure becomes invasive and causes hemodynamic fluctuations

Engineering Contradiction:
Improvesurfactant delivery effectivenessVSAvoidinvasiveness and hemodynamic fluctuations
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent replaces the mechanical bolus injection system with a nebulization system that uses gas-liquid interaction to deliver surfactant. The nebulizer converts liquid surfactant into aerosol particles that can be inhaled by the patient, eliminating the need for invasive intubation and associated mechanical injection procedures.

Inventive Principle:
Principle #28Mechanics substitution (Replace mechanical system)

Solution Approach 2:

The patent changes the physical state and delivery parameters of surfactant from liquid bolus injection to aerosolized particles. By controlling particle size distribution through nebulization parameters (gas flow rate, liquid flow rate, pressure), the system achieves effective lung delivery without invasive procedures.

Inventive Principle:
Principle #35Parameter changes

2Object-affected harmful factors

If nebulization is used to deliver surfactant, then the procedure is less invasive, but surfactant deposition in the lungs is poor

Engineering Contradiction:
Improveinvasiveness reductionVSAvoidsurfactant deposition efficiency
Core Design Contradiction:
Object-affected harmful factorsVSReliability

Solution Approach 1:

The patent optimizes nebulization parameters including gas-to-liquid ratio, pressure, and flow rates to control aerosol particle size. By adjusting these parameters, the system generates particles within the optimal size range (1-10 μm) for deep lung penetration and effective surfactant deposition.

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The system incorporates sensors to monitor aerosol generation and delivery parameters in real-time, with control algorithms that adjust nebulization conditions to maintain optimal particle size and delivery efficiency, ensuring reliable surfactant deposition.

Inventive Principle:
Principle #23Feedback

3Ease of operation

If the nebulizer is not synchronized with the patient's breath, then the device operation is simple, but surfactant is exhaled during expiration

Engineering Contradiction:
Improvedevice operation simplicityVSAvoidsurfactant waste during expiration
Core Design Contradiction:
Ease of operationVSLoss of substance

Solution Approach 1:

The system uses breath detection sensors (flow sensors or pressure sensors) to monitor the patient's respiratory cycle in real-time. The control system processes this feedback signal to synchronize surfactant aerosol delivery with the inspiratory phase, ensuring medication is delivered when the patient inhales and preventing waste during expiration.

Inventive Principle:
Principle #23Feedback

Solution Approach 2:

The nebulizer operates in periodic bursts synchronized with the patient's breathing cycle, activating during inspiration and pausing during expiration. This periodic operation pattern matches the natural respiratory rhythm, maximizing drug delivery efficiency while minimizing waste.

Inventive Principle:
Principle #19Periodic action

4Productivity

If the infusion pump flows surfactant quickly to reduce delivery time, then the productivity increases, but the hydraulic resistance causes delayed response

Engineering Contradiction:
Improvesurfactant delivery speedVSAvoidresponse delay due to hydraulic resistance
Core Design Contradiction:
ProductivityVSLoss of time

Solution Approach 1:

The system uses pressurized gas flow to drive surfactant through the nebulizer, overcoming hydraulic resistance in the fluid pathway. The gas pressure creates a pressure gradient that accelerates liquid surfactant delivery without requiring high pump flow rates, reducing the impact of hydraulic resistance and improving response time.

Inventive Principle:
Principle #29Pneumatics and hydraulics

Solution Approach 2:

The system dynamically adjusts operating parameters including gas pressure, liquid flow rate, and nebulizer configuration to optimize the balance between delivery speed and response time. By changing these parameters adaptively, the system achieves both high productivity and fast response despite hydraulic resistance.

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 system ensures efficient and synchronized delivery of surfactant during inspiration, reducing waste and side effects, and is designed to be compatible with existing hospital equipment for safe and hygienic use.

Implementation Method 1

a pressure sensor along the surfactant line for measuring a value indicative of the pressure in the patient pharyngeal cavity

Methodology Applied
Scientific EffectPressure sensing:

Implementation Method 2

The atomizing catheter includes a first channel where the liquid medicament flows to be conveyed to the patient's pharyngeal region and a second channel that conveys a pressurized flow of gas at the tip of the catheter. The pump moves the column of liquid medicament towards the tip of the catheter so that, when the medicament and the pressurized gas meet in the pharyngeal cavity, the liquid is broken into small particles causing atomization of the medicament

Methodology Applied
Scientific EffectAtomization:

Data Source

PatentEP3285645B1System for effective breath-synchronized delivery of medicament to the lungs
Publication Date: 2020.08.12 CHIESI FARMACEUTICI SPA
  • EP3285645B1 patent drawingFigure 1
  • EP3285645B1 patent drawingFigure 2a~2b
  • EP3285645B1 patent drawingFigure 3

AI summary

The method and system according to preferred embodiments of the present invention allows an effective breath-synchronized delivery of atomized liquid medicament (e.g. a pulmonary surfactant) to the patient's lungs. According to a preferred embodiment, the method of the present invention provides an efficient delivery of the aerosol medicament, controlling the behavior of the infusion pump to make the rising and falling time faster even though the intrinsic time constant of the system is long. Additionally, in an embodiment of the present invention, at the same time the information about the breathing activity contained either directly on the surfactant line or stored in the controller action can be used to extrapolate the breathing pattern.