BFS Vial Pneumatic Delivery for Body Cavity Aerosols

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Solution Overview

Problem

There is a need for an efficient system to deliver substances from Blow-Fill-Seal (BFS) containers to target sites within the body, ensuring sufficient material delivery and reproducibility while minimizing personnel intervention and ensuring the delivery system can produce aerosols effectively for specific body cavities.

Innovation Solution

A device with a pierceable vial and a mechanism to interface with a puncturing member, using pressurized fluid to entrain substances and release them as aerosols within body cavities, optimizing parameters like pressure, gas volume, and orifice size for effective delivery, including a screw mechanism for piercing and a cap for sealing, capable of delivering a range of substances including gases, liquids, and powders.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Extent of automation

If BFS containers are used to store substances, then sterile preparation and reduced personnel intervention are achieved, but efficient delivery of substance to target site and sufficient material delivery are compromised

Engineering Contradiction:
Improvepersonnel interventionVSAvoiddelivery efficiency
Core Design Contradiction:
Extent of automationVSProductivity

Solution Approach 1:

The patent introduces an intermediary delivery system comprising a puncturing member, pressurized fluid chamber, and aerosolization mechanism that mediates between the sealed BFS container and the target site. This intermediary system enables automated substance delivery without direct personnel handling of the sterile container, resolving the contradiction between reduced intervention and efficient delivery.

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The patent employs pneumatic principles by using pressurized gas stored in a chamber to drive the substance from the BFS container through a puncturing member and into an aerosolization chamber. The pressurized fluid propels the substance efficiently to the target site, achieving both automation and high delivery productivity.

Inventive Principle:
Principle #29Pneumatics and hydraulics

2Reliability

If BFS containers are used, then aseptic preparation is improved, but the ability to produce aerosols effectively for specific body cavities deteriorates

Engineering Contradiction:
Improveaseptic preparationVSAvoidaerosol production capability
Core Design Contradiction:
ReliabilityVSAdaptability or versatility

Solution Approach 1:

The delivery system is segmented into distinct functional modules: the sealed BFS container for sterile storage, the puncturing mechanism for access, the pressurized fluid chamber for propulsion, and the aerosolization chamber for particle generation. This segmentation allows each component to be optimized independently, maintaining aseptic integrity while enabling effective aerosol production for specific body cavities.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The system enables parameter changes by adjusting pressurized gas volume, pressure levels, and aerosolization conditions to optimize delivery for different body cavities. The controllable parameters allow the same BFS container system to adapt to various delivery requirements while maintaining sterile conditions.

Inventive Principle:
Principle #35Parameter changes

3Productivity

If rapid delivery with release time less than 500 milliseconds is achieved, then productivity is improved, but control over substance release and aerosol formation may deteriorate

Engineering Contradiction:
Improverelease speedVSAvoidaerosol control
Core Design Contradiction:
ProductivityVSManufacturing precision

Solution Approach 1:

The system performs preliminary actions by pre-storing pressurized gas in the chamber and pre-positioning the puncturing member before activation. When triggered, these pre-prepared elements enable rapid substance release within 500 milliseconds while maintaining control over aerosol formation through the pre-configured delivery pathway and aerosolization chamber conditions.

Inventive Principle:
Principle #10Preliminary 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

The system enables rapid and efficient delivery of substances to body cavities, achieving aerosol formation with controlled distribution and absorption, enhancing the delivery of medicaments to specific tissues like the brain, with a focus on reproducibility and reduced intervention, improving the transfer of medicaments to target areas.

Implementation Method 1

the pressurized fluid flows from the chamber, via the fluid inlet port, entrains the substances, erupts via the fluid discharging outlet port to within the body cavity in the form of aerosol

Methodology Applied
Scientific EffectEntrainment: Entrainment

Implementation Method 2

a pressurized gas volume, an orifice diameter, a substance volume, a release time, a pressure, and a temperature

Methodology Applied
Scientific EffectPressure-driven flow: Pressure Gradient

Data Source

PatentUS11992604B2Devices and methods for delivering a substance to a body cavity
Publication Date: 2024.05.28 APTARGROUP INC
  • US11992604B2 patent drawing
  • US11992604B2 patent drawing
  • US11992604B2 patent drawing

AI summary

The present invention provides methods and a BFS/FFS device for delivering either one or more substances within at least one body cavity, characterized by a vial comprising Vsub [ml] of said substances; said vial from a pierceable container, a blow-fill-seal and a form-fill-seal, having fluid inlet and a fluid discharging outlet of diameter D [mm], configured for placement in proximity to said body cavity; said fluid inlet configured by means of size and shape to interface in a sealable manner a puncturing member, configured to, upon coupling to said fluid inlet, piercing the same, thereby providing said substances in a fluid communication, via a valve, with a chamber configured to accept pressurized fluid at volume VPF [ml] and pressure PPF [barg]; said valve is commutable from an CLOSE to an OPEN CONFIGURATION within a short period of time, <500 milliseconds (dT); at said OPEN CONFIGURATION, said pressurized fluid flows from said chamber, via said fluid inlet, entrains said substances by one erupts via said fluid discharging outlet to within said body cavity.