Dual-Chamber Plastic Bag for Ophthalmic Irrigation

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Solution Overview

Problem

Current packaging systems for two-part ophthalmic irrigation solutions, such as those containing bicarbonate, pose safety risks due to glass bottle breakage, require manual reconstitution with potential for incomplete mixing, and have sterility and environmental concerns.

Innovation Solution

A dual-chamber plastic laminate gas-impermeable bag with a frangible seal and over-wrap, allowing for steam sterilization and easy reconstitution, replacing glass bottles with flexible plastic, and featuring an administration port for safe and efficient use.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If glass bottles are used for packaging two-part ophthalmic irrigation solutions, then terminal sterilization can be achieved, but safety risks increase due to potential breakage

Engineering Contradiction:
Improvesterilization capabilityVSAvoidbreakage risk
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent changes the material parameter from glass to plastic laminate, transforming the packaging material to eliminate breakage risk while maintaining sterilization capability through steam autoclaving. This parameter change resolves the contradiction by selecting a material that is both safe (flexible plastic) and sterilizable.

Inventive Principle:
Principle #35Parameter changes

2Stability of the object's composition

If separate glass bottles are used for two-part solutions, then storage stability is maintained, but reconstitution requires manual manipulation with potential for incomplete mixing

Engineering Contradiction:
Improvesolution stabilityVSAvoidreconstitution ease
Core Design Contradiction:
Stability of the object's compositionVSEase of operation

Solution Approach 1:

The patent merges two separate bottles into a single dual-chamber bag system. The frangible seal separates the chambers during storage to maintain stability, but allows complete mixing when broken during reconstitution. This merging resolves the contradiction by providing both stability during storage and ease of complete reconstitution during use.

Inventive Principle:
Principle #5Merging (Combining)

Solution Approach 2:

The patent segments the solution into two separate chambers within a single flexible bag, each containing one component. The frangible seal provides a predetermined break point that ensures complete mixing when broken, eliminating the manual manipulation issues of separate bottles while maintaining storage stability.

Inventive Principle:
Principle #1Segmentation

3Reliability

If one bottle is sterilized via sterile filtration and aseptically filled, then sterility is maintained, but the risk of non-sterile contamination increases

Engineering Contradiction:
ImprovesterilityVSAvoidcontamination risk
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent changes the sterilization parameter from sterile filtration to steam autoclaving, allowing both chambers to be terminally sterilized in a single process. This eliminates the contamination risk associated with aseptic filling while maintaining sterility through a more reliable terminal sterilization method.

Inventive Principle:
Principle #35Parameter changes

4Reliability

If glass bottles are used for packaging, then solution containment is achieved, but shipping and disposal difficulty increases with environmental impact

Engineering Contradiction:
Improvecontainment capabilityVSAvoidshipping and disposal ease
Core Design Contradiction:
ReliabilityVSEase of manufacture

Solution Approach 1:

The patent replaces rigid glass bottles with flexible plastic laminate bags. The flexible material provides adequate containment while being lightweight for shipping and easily disposable with reduced environmental impact. This resolves the contradiction by selecting a material that maintains containment functionality while improving shipping and disposal characteristics.

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 dual-chamber packaging system enhances patient safety, reduces environmental impact, and simplifies handling and disposal while ensuring sterility and complete reconstitution of ophthalmic irrigation solutions.

Implementation Method 1

a frangible (releasable) seal separating the first and second chambers

Methodology Applied
Scientific EffectFrangible seal breaking:

Implementation Method 2

a plastic laminate gas-impermeable dual-chamber bag

Methodology Applied
Scientific EffectGas barrier property: Permeation

Implementation Method 3

All of the components of the dual-chamber solution packaging system can withstand steam sterilization

Methodology Applied
Scientific EffectSteam sterilization:

Data Source

PatentEP1937202B1Dual-chamber solution packaging system
Publication Date: 2010.01.27 ALCON INC
  • EP1937202B1 patent drawingFigure 1
  • EP1937202B1 patent drawingFigure 2
  • EP1937202B1 patent drawingFigure 3

AI summary

A solution packaging system (10) is disclosed. One embodiment of the solution packaging system of the present invention comprises a gas-impermeable dual-chamber bag (15) , having a first chamber (30) and a second chamber (35) separated by a frangible (releasable) seal (25) , and an over-wrap member (20) enclosing and containing the dual-chamber inner bag. The dual-chamber bag can be used to package two-part medicinal solutions containing bicarbonate, such as ophthalmic irrigation solutions. The over-wrap member can serve as a dust cover and need not be a moisture or gas barrier, as the dual-chamber inner bag will have sufficient gas barrier properties to minimize the loss of CO2 from the first part of the solution (e.g., the bicarbonate) . The dual-chamber bag can be fitted with an administration port (110) , and sealed with a stopper and an aluminum crimp seal. The dual-chamber bag can further comprise fill-ports (100) to fill each chamber. The fill port openings can be sealed after filling the chambers and the fill ports cut from the dual-chamber bag. The frangible seal between the chambers of the embodiments of this invention can be broken by the end user to mix and reconstitute the two parts of the solution prior to use.