Fluid Transfer Device for Sterile Medicament Reconstitution

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Solution Overview

Problem

The preparation and administration of medicaments through infusion or injection are complex and challenging, especially for patients requiring regular intravenous infusions, due to the need for sterile environments and the complexity of reconstituting medicaments from multiple vials, which can lead to long preparation times and a high risk of errors and contamination.

Innovation Solution

A fluid transfer device with a body comprising connecting portions for diluent and medicament containers, fluid channels, and a flow control member that allows selective fluid communication between these components, enabling reconstitution and pooling of medicaments while preventing premature exchange or contamination, and can be easily operated to facilitate reconfiguration for administration.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Adaptability or versatility

If multiple vials are used for reconstitution of medicaments, then the medicament can be prepared according to specific patient needs, but the preparation process becomes complex and time-consuming

Engineering Contradiction:
Improvecustomization of medicament preparationVSAvoidpreparation time
Core Design Contradiction:
Adaptability or versatilityVSLoss of time

Solution Approach 1:

The patent combines multiple vial connections and fluid transfer operations into a single integrated device. The device allows simultaneous connection of multiple vials and automated fluid transfer between them, merging what would otherwise be separate manual operations into one unified system that reduces preparation time while maintaining customization capability

Inventive Principle:
Principle #5Merging (Combining)

Solution Approach 2:

The device is designed with multi-functional capabilities to handle various vial types and configurations. It can connect to multiple different vials, perform different operations (transfer, mixing, pooling), and adapt to different medicament preparation protocols, thereby reducing the time needed to switch between different preparation tasks

Inventive Principle:
Principle #6Universality (Multi-functionality)

2Adaptability or versatility

If manual reconstitution and pooling of medicaments is performed, then flexibility in medicament preparation is achieved, but the risk of errors and contamination increases

Engineering Contradiction:
Improveflexibility in medicament preparationVSAvoidrisk of errors and contamination
Core Design Contradiction:
Adaptability or versatilityVSReliability

Solution Approach 1:

The device incorporates automated fluid transfer mechanisms that perform the reconstitution and pooling operations without direct manual intervention. The system self-regulates fluid flow between vials, automatically mixing and pooling medicaments according to programmed parameters, thereby maintaining flexibility while eliminating human error and contamination risks

Inventive Principle:
Principle #25Self-service

Solution Approach 2:

The device acts as an intermediary between the vials and the final medicament product. It provides a controlled environment for fluid transfer with built-in safety features, sterilization capabilities, and error prevention mechanisms, mediating the preparation process to ensure reliability while preserving preparation flexibility

Inventive Principle:
Principle #24Intermediary (Mediator)

3Reliability

If sterile environment is maintained for home-medication, then patient safety is improved, but the complexity of storage and handling increases

Engineering Contradiction:
Improvepatient safetyVSAvoidstorage and handling complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The device utilizes disposable components such as single-use vials, connectors, and fluid path elements that are pre-sterilized. These disposable elements eliminate the need for complex sterilization procedures and storage requirements, maintaining patient safety through factory sterilization while simplifying home storage and handling

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

Solution Approach 2:

The device is designed with modular, separable components that can be individually sterilized and stored. The segmentation allows each component to be independently packaged in sterile condition, reducing the overall complexity of maintaining sterility for the entire system while ensuring patient safety through component-level sterilization control

Inventive Principle:
Principle #1Segmentation

Data Source

PatentUS12171719B1Fluid transfer device
Publication Date: 2024.12.24 GENZYME CORP
  • US12171719B1 patent drawing
  • US12171719B1 patent drawing
  • US12171719B1 patent drawing

AI summary

A fluid transfer device includes a body having a first connecting portion for connecting with a diluent container, and a second connecting portion for connecting with a medicament container. A first fluid channel extends into the first connecting portion, and a second fluid channel extends into the second connecting portion. A discharge duct is configured to connect to a discharge device. A flow control member is selectively fluidically connectable to the first and second fluid channels, the discharge duct, and a discharge channel. The flow control member is movably disposed in or on the body and is movable relative to the body between first and second control positions. In the first control position, the first and second fluid channels are in fluid communication. In the second control position, the discharge duct is in fluid communication with the discharge channel and the first fluid channel or the second fluid channel.