Biologic Nebulizer With Passive Venting for Stable Aerosolization
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Solution Overview
Problem
Nebulizers for delivering biologic drugs face challenges in maintaining effective aerosolization without foaming or denaturation due to negative pressure in the reservoir, leading to quality deterioration and potential termination of the nebulizing process.
Innovation Solution
A nebulizer design featuring a vibratable membrane with a piezoelectric actuator, a plenum chamber, and a passive vent to maintain atmospheric pressure, combined with a reservoir vent to prevent foaming and ensure consistent aerosol delivery.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Productivity
If a sealed reservoir is used to maintain negative pressure for increasing nebulization efficiency, then aerosol generation rate is improved, but foaming occurs and biologic denaturation is caused
Solution Approach 1:
The patent extracts the harmful effect of negative pressure by introducing a vent that allows air to enter the reservoir, eliminating the negative pressure condition that causes foaming and biologic denaturation while maintaining adequate aerosol generation
Solution Approach 2:
The patent converts the harmful negative pressure into a beneficial controlled pressure system by using a vent with specific flow resistance that allows minimal air leakage to prevent foaming while maintaining sufficient negative pressure for aerosol generation
2Reliability
If a vent is added to prevent foaming, then biologic stability is improved, but device complexity increases
Solution Approach 1:
The patent merges the vent function with the existing reservoir structure by forming the vent as an integral part of the reservoir wall or lid, eliminating the need for separate vent components and reducing overall device complexity
Solution Approach 2:
The vent structure serves multiple functions: it prevents foaming by allowing air entry, controls pressure differential, and maintains structural integrity of the reservoir, thereby reducing the need for additional specialized components
3Productivity
If membrane vibration frequency is increased to improve aerosol output, then productivity is improved, but shear forces increase causing biologic destruction
Solution Approach 1:
The patent employs dynamic control of the piezoelectric actuator to optimize membrane vibration characteristics, adjusting frequency and amplitude to achieve adequate aerosol output while maintaining shear forces below the threshold for biologic destruction
Solution Approach 2:
The patent changes the physical parameters of aerosol generation by using ultrasonic vibration frequencies that produce sufficient aerosol output without generating excessive shear forces, finding an optimal frequency range that balances productivity and biologic stability
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
Minimizes shear forces and heat transfer, preventing biologic denaturation while ensuring a high delivered dose with reduced residue and consistent aerosol quality.
Implementation Method 1
a piezoelectric actuator for vibrating the membrane, whereby an aerosol of the liquid solution is generated at the active area
Implementation Method 2
a vibratable membrane having an active area with apertures, wherein the liquid solution is feedable to the active area... the piezoelectric actuator for vibrating the membrane
Data Source
Figure 1~2
Figure 3(A)~3(C)
Figure 4~6
AI summary
The invention relates to a drug-device combination comprising a liquid solution (26) containing a biologic, and a nebulizer (10) for aerosolization of the liquid solution. The nebulizer comprises: a reservoir (24) for holding the liquid solution, the reservoir (24) having a vent (48) for maintaining atmospheric pressure in the reservoir (24); a vibratable membrane (60) having an active area (62) with apertures (110), wherein the liquid solution is feedable to the active area at a liquid side (64) of the membrane; a piezoelectric actuator for vibrating the membrane, whereby an aerosol of the liquid solution is generated at the active area at an aerosol side (66) of the membrane; and a plenum chamber (23) having an inlet (76) at an inlet side at the aerosol side of the membrane and an outlet (94) at an outlet side for administering the aerosol.