Passive Needle Guard for Lyophilized Drug Reconstitution

Solution Overview

Problem

Current syringe systems for reconstituting lyophilized drugs often expose users to the risk of needle sticks and do not adequately prevent syringe reuse, as safety shields activate prematurely during the reconstitution phase, interfering with the mixing process.

Innovation Solution

A syringe system with a passive needle guard that remains retracted during reconstitution and automatically activates to cover the needle after administration, using a clip to prevent premature activation and ensure safe needle shielding.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Object-affected harmful factors

If a passive needle guard is used to prevent accidental needle sticks, then needle safety is improved, but the safety shield activates prematurely during reconstitution, interfering with the mixing process

Engineering Contradiction:

Improveneedle stick riskVSAvoidreconstitution process

Core Design Contradiction:

Object-affected harmful factorsVSEase of operation

Solution Approach 1:

The needle guard system transitions from a static protective state during reconstitution to an active protective state during administration. The trigger mechanism dynamically responds to plunger position, automatically activating the shield only when the plunger is fully advanced, thus preventing premature activation during mixing while ensuring protection during injection.

Inventive Principle:

Principle #15Dynamics

Solution Approach 2:

The system is pre-configured with a trigger mechanism that anticipates the administration phase. The trigger finger is positioned to detect when the plunger reaches full advancement, automatically initiating the shield extension before the needle can pose a risk, thus preparing the protective action in advance of the actual need.

Inventive Principle:

Principle #10Preliminary action

2Object-affected harmful factors

If a safety shield is activated to cover the needle after administration, then needle stick prevention is improved, but the shield cannot be activated during reconstitution as it interferes with the mixing process

Engineering Contradiction:

Improveneedle exposureVSAvoidmulti-phase functionality

Core Design Contradiction:

Object-affected harmful factorsVSAdaptability or versatility

Solution Approach 1:

The needle guard system transitions from a static protective state during reconstitution to an active protective state during administration. The trigger mechanism dynamically responds to plunger position, automatically activating the shield only when the plunger is fully advanced, thus preventing premature activation during mixing while ensuring protection during injection.

Inventive Principle:

Principle #15Dynamics

Solution Approach 2:

Different phases of the process receive different levels of protection. During reconstitution, the system maintains needle accessibility with the shield retracted. During administration, the system provides full protection with the shield extended. This localized quality adjustment ensures safety is provided exactly when and where needed without interfering with other operations.

Inventive Principle:

Principle #3Local quality

3Extent of automation

If the plunger thumb pad contacts the trigger finger to activate the shield, then automatic needle protection is improved, but the same mechanism causes premature activation during diluent injection

Engineering Contradiction:

Improveautomatic shield activationVSAvoidreconstitution time

Core Design Contradiction:

Extent of automationVSLoss of time

Solution Approach 1:

The needle guard system transitions from a static protective state during reconstitution to an active protective state during administration. The trigger mechanism dynamically responds to plunger position, automatically activating the shield only when the plunger is fully advanced, thus preventing premature activation during mixing while ensuring protection during injection.

Inventive Principle:

Principle #15Dynamics

Solution Approach 2:

The system uses the parameter of plunger position as the trigger condition. By monitoring whether the plunger is fully advanced (indicating administration phase) versus partially advanced (reconstitution phase), the system automatically adjusts its protective state. This parameter-based control eliminates premature activation while maintaining automatic protection when needed.

Inventive Principle:

Principle #35Parameter changes

Data Source

PatentUS10702663B2Reconstitution means for safety device

Publication Date: 2020.07.07 SAFETY SYRINGES INC

AI summary

The present disclosure describes a needle guard device or system that can be used with drugs requiring reconstitution. The needle guard is preferably a passive needle guard that can be used during reconstitution without activating the safety mechanism. Following administration of the medication, the needle guard shields a user from inadvertent needle sticks by extending a protective shield over the needle.