Plunger Sub-Assembly with Radially Flexing Prongs for Auto-Injector

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Solution Overview

Problem

Automatic injectors for retractable syringes often fail to provide adequate safety features, such as automatic needle retraction and clear end-of-dose indication, leading to potential needlestick injuries and misuse by self-administering patients.

Innovation Solution

The development of a plunger sub-assembly with a low retraction activation force mechanism, incorporating a compression spring and engagement prongs that radially flex to disengage from the plunger inner, allowing for automatic needle retraction and true end-of-dose indication, integrated into an automatic injector design with a housing, activation mechanism, and syringe cartridge.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Force

If a compression spring is used to provide retraction force, then the retraction force is sufficient to retract the needle, but the activation force required to initiate retraction is too high

Engineering Contradiction:
Improveretraction forceVSAvoidactivation force
Core Design Contradiction:
ForceVSEase of operation

Solution Approach 1:

The engagement prongs are designed to transition from a rigid engaged state during drug delivery to a flexible disengaged state during retraction. The prongs flex radially outward when the plunger outer reaches a specific position, dynamically changing the mechanical engagement to reduce activation force for needle retraction.

Inventive Principle:
Principle #15Dynamics

Solution Approach 2:

The engagement prongs change their mechanical properties by flexing radially, altering the engagement parameter from locked to disengaged. This parameter change allows the compression spring to release and retract the needle with low activation force, while maintaining high retraction force once initiated.

Inventive Principle:
Principle #35Parameter changes

2Reliability

If the engagement prongs are rigid to maintain structural integrity, then the device is reliable, but the activation force to disengage them is too high

Engineering Contradiction:
Improvestructural integrityVSAvoidactivation force
Core Design Contradiction:
ReliabilityVSEase of operation

Solution Approach 1:

The engagement prongs transition from a rigid structural element during drug delivery to a flexible component during retraction. This dynamic behavior maintains structural integrity when needed while enabling easy activation when the retraction phase is reached.

Inventive Principle:
Principle #15Dynamics

3Device complexity

If the plunger outer and plunger inner remain engaged throughout the stroke, then the device is simple, but the needle cannot be automatically retracted

Engineering Contradiction:
Improveengagement mechanismVSAvoidneedle retraction
Core Design Contradiction:
Device complexityVSReliability

Solution Approach 1:

The engagement between plunger outer and plunger inner is dynamic rather than static. The engagement prongs automatically disengage when the plunger outer reaches the retraction position, enabling automatic needle retraction without complex additional mechanisms.

Inventive Principle:
Principle #15Dynamics

Solution Approach 2:

The plunger sub-assembly automatically initiates needle retraction through the flexing engagement prongs and compression spring mechanism without requiring external intervention. The system serves itself by using the existing mechanical components to achieve automatic retraction.

Inventive Principle:
Principle #25Self-service

4Ease of operation

If the engagement prongs flex radially to disengage, then the activation force is reduced, but the manufacturing precision required is higher

Engineering Contradiction:
Improveactivation forceVSAvoidprong flexion geometry
Core Design Contradiction:
Ease of operationVSManufacturing precision

Solution Approach 1:

The engagement prongs are designed with specific geometric parameters that allow controlled radial flexion. By optimizing the prong dimensions and material properties, the design achieves the desired flexibility while maintaining manufacturability and functional reliability.

Inventive Principle:
Principle #35Parameter changes

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

The solution provides enhanced safety by automatically retracting the needle, preventing injuries, and ensuring users are aware when the dose is complete, reducing the force required for retraction and simplifying the device's operation and manufacturing.

Implementation Method 1

a plunger biasing member, which may be a spring such as a compression spring, is retained in a first energized state between the plunger outer and plunger inner

Methodology Applied
Scientific EffectSpring: Spring

Implementation Method 2

The one or more engagement prongs are capable of flexing substantially radially to release from engagement with the shoulder of the plunger inner to permit the plunger spring to expand

Methodology Applied
Scientific EffectElasticity: Elasticity

Data Source

PatentUS10300201B2Plunger sub-assemblies and auto-injectors having low retraction activation force
Publication Date: 2019.05.28 AMGEN INC
  • US10300201B2 patent drawing
  • US10300201B2 patent drawing
  • US10300201B2 patent drawing

AI summary

A low retraction activation force plunger sub-assembly for an automatic injector includes: a plunger outer having one or more engagement prongs, a plunger inner having a shoulder, and a plunger biasing member retained in a first energized state between said plunger outer and plunger inner when the engagement prongs of the plunger outer are releasably engaged with the shoulder of the plunger inner. An automatic injector includes a housing, an activation mechanism, an actuation mechanism, and a syringe cartridge having the plunger sub-assembly and a needle assembly, wherein the actuation mechanism includes comprises an actuation biasing member residing in an initial energized state substantially within an upper portion of an actuation pill. A method of assembling the automatic injector includes the steps of: assembling the plunger sub-assembly and inserting the plunger sub-assembly into the housing such that a proximal end of the plunger sub-assembly contacts the actuation pill.