Floating Needle Transfer Set for Safe Drug Reconstitution

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Solution Overview

Problem

Current drug reconstitution methods are labor-intensive and prone to contamination and user error, with a need for a safer and more accurate activation system that prevents premature needle exposure and allows flexibility in assembly and attachment of containers.

Innovation Solution

A transfer set with a cylindrical housing that allows bidirectional fluid communication between a cartridge and a vial, featuring a needle assembly with a locking structure that prevents premature release and re-exposure, and allows for pre-assembled kits or user-attached configurations, ensuring safe and flexible assembly.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of operation

If a traditional syringe-based reconstitution method is used, then the user can manually inject diluent into the dry drug vial, but the process is labor-intensive and prone to contamination and user error

Engineering Contradiction:

Improveease of reconstitutionVSAvoidrisk of contamination and user error

Core Design Contradiction:

Ease of operationVSReliability

Solution Approach 1:

The device enables self-service reconstitution by allowing the patient to independently attach the vial and cartridge to the adapter assembly and activate the needle mechanism without requiring assistance from a medical practitioner, thereby improving ease of operation while maintaining reliability through built-in safety features

Inventive Principle:

Principle #25Self-service

Solution Approach 2:

The adapter assembly serves as an intermediary device that mediates between the vial and cartridge, providing a controlled environment for reconstitution that reduces contamination risk through its sealed design and controlled needle exposure mechanism

Inventive Principle:

Principle #24Intermediary (Mediator)

2Productivity

If the needle is exposed for reconstitution, then fluid communication can be established between containers, but premature exposure or connection could lead to contamination or loss of drug

Engineering Contradiction:

Improvespeed of reconstitutionVSAvoidrisk of contamination

Core Design Contradiction:

ProductivityVSReliability

Solution Approach 1:

The needle is pre-positioned within the adapter assembly in a retracted state before use, and the vial and cartridge are pre-attached to the adapter. The needle is only exposed when the user intentionally activates the mechanism, ensuring that fluid communication is established only when intended and preventing premature contamination

Inventive Principle:

Principle #10Preliminary action

Solution Approach 2:

The locking structure provides preliminary anti-action by preventing needle exposure until the user deliberately activates the release mechanism, thereby counteracting the risk of premature needle exposure and contamination before the reconstitution process begins

Inventive Principle:

Principle #9Preliminary anti-action

3Productivity

If the needle mechanism is made easily activatable, then the reconstitution process is faster, but the needle may be prematurely exposed or connected

Engineering Contradiction:

Improvespeed of activationVSAvoidrisk of user error

Core Design Contradiction:

ProductivityVSEase of operation

Solution Approach 1:

The vial and cartridge are pre-attached to the adapter assembly during manufacturing, and the needle is pre-positioned in a locked state. This preliminary configuration allows for rapid activation by the user while preventing user error during assembly, as the components are designed to be attached in a specific sequence and orientation

Inventive Principle:

Principle #10Preliminary action

4Adaptability or versatility

If the device allows flexible assembly configurations, then it can be provided as pre-assembled kit or separate components, but the activation system must ensure safe needle control

Engineering Contradiction:

Improveflexibility in assemblyVSAvoidneedle safety control

Core Design Contradiction:

Adaptability or versatilityVSReliability

Solution Approach 1:

The adapter assembly is designed with universal features that allow it to function in multiple configurations: it can be provided as part of a pre-assembled kit with the vial and cartridge attached, or as a separate component to which the vial and cartridge are attached by the user just prior to use. The locking structure ensures needle safety control in both configurations

Inventive Principle:

Principle #6Universality (Multi-functionality)

Solution Approach 2:

The needle holder is designed to be dynamically controllable, transitioning from a locked retracted state to an active extended state only when the user intentionally activates the mechanism. This dynamic control ensures needle safety regardless of whether the device is used in pre-assembled or separate component configuration

Inventive Principle:

Principle #15Dynamics

Data Source

PatentUS11351091B2Transfer set with floating needle for drug reconstitution

Publication Date: 2022.06.07 BECTON DICKINSON & CO

AI summary

An adapter assembly for establishing bidirectional fluid connection between a cartridge and a vial includes a housing having an open first end adapted to engage the cartridge and a second open end adapted to engage the vial. The adapter includes a needle assembly having a first tip and a second tip, with the needle assembly disposed within the housing and at least partially supported by a needle holder. The needle assembly is movable relative to the housing from an initial position in which the first and second tip are isolated from the cartridge and vial, to an end of use position, in which first tip is engaged with the vial and the second tip is engaged with the cartridge, establishing fluid communication therebetween. The needle assembly is maintained in the initial position by a locking structure which is released by rotationally advancing the needle holder relative to the housing.