Binary Connector for Reconstitution with Activation Indicators

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Solution Overview

Problem

Conventional adaptors for reconstituting medications in intravenous solutions are not intuitive to use, lack indicators for activation status, and are prone to accidental activation or reuse, leading to potential contamination and inefficiencies in drug preparation.

Innovation Solution

A binary connector system with a control valve and seal body that allows fluid connection between a drug container and a solution container in a closed state, with a rotatable shaft and locking mechanism to ensure secure activation and prevent reuse, featuring indicators for activation status and seals to prevent leakage.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of operation

If conventional adaptors are used for reconstitution, then fluid connection between drug container and solution container is established, but the adaptors are not intuitive to use and lack indicators for activation status

Engineering Contradiction:

Improveintuitiveness of useVSAvoidactivation status indication

Core Design Contradiction:

Ease of operationVSLoss of information

Solution Approach 1:

The patent employs color-coded components and visual indicators to show activation status. The connector includes visible indicators that change appearance or position to clearly indicate whether the connector is in closed or activated state, making the device intuitive to use and eliminating uncertainty about activation status.

Inventive Principle:

Principle #32Color changes

Solution Approach 2:

The connector provides immediate visual feedback to the user about its activation state through indicators that are visible without disassembly. This feedback mechanism allows users to confirm proper assembly and activation status, eliminating the information loss about whether the connector is ready for use.

Inventive Principle:

Principle #23Feedback

2Reliability

If conventional adaptors are used, then reconstitution can be performed, but accidental activation or reuse may occur leading to contamination

Engineering Contradiction:

Improveprevention of accidental activationVSAvoidcontamination risk

Core Design Contradiction:

ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The connector is designed with pre-assembled components that are prepared in advance but remain in a closed, non-activated state during storage and transport. The activation mechanism requires a specific user action that cannot be accidentally triggered, ensuring that reconstitution only occurs when intentionally activated by the user.

Inventive Principle:

Principle #10Preliminary action

Solution Approach 2:

The connector is designed as a single-use disposable device that is discarded after one activation. This eliminates the risk of reuse and contamination from previous use, as the connector cannot be reactivated or reused. The disposable nature ensures reliability by preventing accidental or intentional reuse.

Inventive Principle:

Principle #27Cheap short-living objects (Disposable)

3Duration of action of stationary object

If drugs and diluents are kept separate, then shelf life is extended, but thorough mixing takes time delaying administration

Engineering Contradiction:

Improveshelf life of separate componentsVSAvoidmixing time

Core Design Contradiction:

Duration of action of stationary objectVSLoss of time

Solution Approach 1:

The connector and components are pre-assembled and prepared in advance during pharmacy bulk preparation, but the actual mixing is delayed until right before administration. The connector maintains a closed state during storage, preserving shelf life, then enables rapid mixing when activated, minimizing the time loss before administration.

Inventive Principle:

Principle #10Preliminary action

Solution Approach 2:

The mixing process is extracted and separated from the storage process. Components are stored separately to maintain shelf life, then quickly combined through the activated connector immediately before administration. This separation allows shelf life to be maximized while mixing time is minimized to only what is necessary for actual administration.

Inventive Principle:

Principle #2Taking out (Extraction)

4Reliability

If a coring configuration is used to remove septum plug, then fluid passage is opened, but the plug may become lodged inside the spike blocking flow

Engineering Contradiction:

Improveopening of fluid passageVSAvoidplug blockage

Core Design Contradiction:

ReliabilityVSObject-generated harmful factors

Solution Approach 1:

The septum plug is completely extracted and removed from the system during the coring process. Instead of leaving the plug inside the spike where it could block flow, the design ensures the plug is fully removed and discarded, eliminating the harmful blockage effect while maintaining reliable fluid passage opening.

Inventive Principle:

Principle #2Taking out (Extraction)

Data Source

PatentUS20230301874A1Binary connector for reconstitution

Publication Date: 2023.09.28 B BRAUN MEDICAL INC

AI summary

A device and method for fluidly connecting a drug container with a solution container in a closed state, and for combining contents of the drug container and the solution container in an activated state. The device has a connector body with a first coupling and first fluid passage that connect with the drug container. The connector body also has a second coupling and second fluid passage that connect with the solution container. A control valve has a movable valve body that defines a third fluid passage. The valve body is positionable relative to the connector body in a first position that blocks fluid communication between the first fluid passage and second fluid passage. The valve body is also positionable in a second position that permits fluid communication between the first fluid passage and second fluid passage.