Stackable Crystalline IV Container for On-Demand Reconstitution

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Solution Overview

Problem

Current IV solutions face challenges such as high storage and shipping costs, chemical instability, and labor-intensive manual preparation, which can lead to contamination and inefficiencies in delivering medications to patients.

Innovation Solution

The development of stackable, machine-manipulable IV solution containers that store crystalline hydration chemicals and therapeutic drugs, which can be reconstituted with sterile water on demand, using robotic systems for efficient preparation and labeling, reducing the need for centralized pharmacy preparation and enhancing storage and shipping efficiency.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of operation

If IV solutions are stored and shipped as complete fluid products, then they are ready for immediate use, but they require immense amounts of storage space, are heavy, and are expensive to ship

Engineering Contradiction:
Improveimmediacy of useVSAvoidstorage and shipping weight
Core Design Contradiction:
Ease of operationVSWeight of stationary object

Solution Approach 1:

The IV solution is divided into two separate components: a sterile water component and a crystalline ingredient component. This segmentation allows the heavy water portion to be excluded from shipping, sending only the lightweight crystalline ingredients to healthcare facilities where they are reconstituted on-demand, thereby reducing storage and shipping weight while maintaining immediate availability when needed.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The crystalline ingredients are pre-prepared and sterilized during manufacturing, then shipped in a stable, space-efficient form. The actual reconstitution action is performed preliminarily at the point of use rather than in advance, allowing the system to maintain readiness without the burden of storing large volumes of finished fluid.

Inventive Principle:
Principle #10Preliminary action

2Ease of operation

If drugs are manufactured in liquid IV solution form, then they are ready for administration, but they cannot easily survive the quality/regulatory systems and supply chain due to chemical instability

Engineering Contradiction:
Improvereadiness for administrationVSAvoidchemical stability
Core Design Contradiction:
Ease of operationVSReliability

Solution Approach 1:

The drug is transformed from a liquid state to a crystalline solid state. This parameter change fundamentally alters the chemical stability and physical properties of the drug, allowing it to withstand the rigors of manufacturing, storage, and supply chain distribution without degradation, while still enabling ready administration through simple reconstitution.

Inventive Principle:
Principle #35Parameter changes

3Adaptability or versatility

If manual preparation of IV solutions is performed in healthcare facilities, then customization is possible, but it is hazardous due to human error and contamination, and is labor-intensive

Engineering Contradiction:
Improvecustomization capabilityVSAvoidcontamination and human error
Core Design Contradiction:
Adaptability or versatilityVSObject-affected harmful factors

Solution Approach 1:

The system enables automated self-service reconstitution through robotic components that automatically assemble the IV solution by combining the crystalline ingredients with sterile water according to prescribed parameters. This eliminates human hands-on preparation, thereby removing the hazards of contamination and human error while preserving the ability to customize dosages and formulations.

Inventive Principle:
Principle #25Self-service

Solution Approach 2:

Manual mechanical preparation by healthcare workers is replaced with an automated robotic system that performs the reconstitution process. This substitution maintains customization capability through programmable control while eliminating the harmful factors associated with manual handling, such as contamination and human error.

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

4Adaptability or versatility

If special adapter containers are used for IV solutions, then vials can be attached for activation, but the IV solutions add cost and the activation process is complex with failure rates

Engineering Contradiction:
Improvevial attachment capabilityVSAvoidactivation process complexity
Core Design Contradiction:
Adaptability or versatilityVSDevice complexity

Solution Approach 1:

The complex adapter mechanism and activation process are completely removed from the system. Instead of using special adapter containers that require attachment and activation steps, the invention uses simple, standalone containers with crystalline ingredients that are directly reconstituted, thereby eliminating device complexity and associated failure rates while maintaining versatility.

Inventive Principle:
Principle #2Taking out (Extraction)

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

This approach reduces storage and shipping costs, ensures better potency and sterility of IV doses, and allows for real-time reconstitution near patient care units, improving the availability and immediacy of IV medications.

Implementation Method 1

an expandable sealing membrane sealed to the rigid portion to form a cavity

Methodology Applied
Scientific EffectElasticity: Elasticity

Implementation Method 2

crystalline contents of an intravenous (IV) solution dose may be reconstituted with sterile water for injection just prior to use

Methodology Applied
Scientific EffectDissolution: Solvation

Data Source

PatentEP3718527B1Reconstitution device for iv fluids and method of use
Publication Date: 2024.02.28 CAREFUSION 303 INC
  • EP3718527B1 patent drawingFigure 1~2
  • EP3718527B1 patent drawingFigure 3
  • EP3718527B1 patent drawingFigure 4

AI summary

A system is provided for storage and reconstitution of IV solutions. The system may include one or more storage and reconstitution devices each configured to store and manipulate IV solution containers containing IV solutions in crystalline form that include hydration chemicals and therapeutic drugs. Crystalline hydration chemicals may include crystalline salts and sugars. The containers may be dimensionally precise enough for mechanical manipulation and configured such that sharp objects such as needles are not needed for fluid delivery to or from the container. Each storage and reconstitution device may store stacked containers and may include components for retrieval of a container from the storage and for reconstitution of the contents therein using a sterile water source within the device. IV doses may be manufactured, under appropriate standards, that can be mechanically reconstituted to produce high-quality doses in real time on the patient care unit or in the pharmacy.