Preservative-Free Single-Dose Inhaler with Vibratable Membrane

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Solution Overview

Problem

Existing inhalers are not suited for delivering unit doses of aerosolized insulin in a repeatable and predictable manner for pulmonary delivery, particularly for type I and II diabetic patients.

Innovation Solution

A single-dose aerosolization system comprising a squeezable container with a resilient body and a vibratable membrane aerosolizer, which includes a hollow needle to pierce the container and deliver a precise dose of liquid insulin to the membrane, ensuring complete aerosolization of a preservative-free solution without ambient air contact, thereby avoiding the need for preservatives and evaporative losses.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Manufacturing precision

If a conventional inhaler is used to aerosolize insulin, then the device may be simple in structure, but it cannot deliver unit doses in a repeatable and predictable fashion

Engineering Contradiction:
Improvedose delivery precisionVSAvoidinhaler structure complexity
Core Design Contradiction:
Manufacturing precisionVSDevice complexity

Solution Approach 1:

The system divides the insulin delivery process into discrete unit doses contained in individual single-use containers. Each container holds a pre-measured unit dose of insulin, ensuring precise and repeatable delivery without requiring complex dosing mechanisms in the inhaler device itself.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The insulin is pre-aerosolized and pre-dosed within the single-use container before use. This preliminary preparation eliminates the need for complex real-time dosing and aerosolization control mechanisms, simplifying the inhaler structure while ensuring precise dose delivery.

Inventive Principle:
Principle #10Preliminary action

2Reliability

If preservatives are added to insulin solution for multi-dose use, then the solution can be stored longer, but it increases contamination risks and is not suitable for pulmonary delivery

Engineering Contradiction:
Improvesolution stabilityVSAvoidcontamination risk
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The system uses disposable single-use containers that are discarded after one use. This eliminates the need for preservatives entirely, as each container is used immediately and discarded, preventing any contamination risk while maintaining solution stability without adding harmful chemical agents.

Inventive Principle:
Principle #27Cheap short-living objects (Disposable)

Solution Approach 2:

The preservative component is completely removed from the system by using single-use containers. Each container is sealed and sterile until use, eliminating the need for preservatives that would otherwise be required to maintain stability in multi-dose formulations.

Inventive Principle:
Principle #2Taking out (Extraction)

3Ease of operation

If the container is not properly sealed, then access to the liquid is easier, but ambient air contact causes evaporative losses and contamination

Engineering Contradiction:
Improvecontainer access easeVSAvoidinsulin evaporative loss
Core Design Contradiction:
Ease of operationVSLoss of substance

Solution Approach 1:

A needle serves as an intermediary element that pierces the sealed container to access the insulin solution. This allows the container to remain tightly sealed during storage and transport, preventing evaporative losses and contamination, while still enabling easy access through simple needle insertion at the point of use.

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The container uses a flexible sealed membrane or film that can be pierced by a needle. This maintains an airtight seal during storage to prevent evaporation and contamination, while allowing easy access through needle puncture without requiring the container to be opened in a traditional sense.

Inventive Principle:
Principle #30Flexible shells and thin films

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 nearly complete delivery of the insulin dose with each use, minimizing waste and contamination risks, and is designed for efficient pulmonary delivery with high precision and reliability.

Implementation Method 1

an aerosol generator that comprises a vibratable membrane having a front face and a rear face, and a vibratable element used to vibrate the membrane

Methodology Applied
Scientific EffectVibration: Vibration

Implementation Method 2

a squeezable container having a resilient container body configured to deliver a unit dosage of a liquid when squeezed a single time

Methodology Applied
Scientific EffectPressure: Pressure Increase

Data Source

PatentUS11833291B2Preservative-free single dose inhaler systems
Publication Date: 2023.12.05 AERAMI THERAPEUTICS INC
  • US11833291B2 patent drawing
  • US11833291B2 patent drawing
  • US11833291B2 patent drawing

AI summary

An aerosolization system includes a container that is configured to deliver a unit dosage of a liquid when squeezed a single time. The system also includes an aerosolizer that is constructed of a housing defining a mouthpiece, and an aerosol generator disposed in the housing. The aerosol generator includes a vibratable membrane having a front face and a rear face, and a vibratable element used to vibrate the membrane. Further, the housing includes an opening that is adapted to receive a unit dosage of the liquid from the container. The opening provides a liquid path to the rear face of the vibratable membrane.