Frost Protected Injection Device with Decoupling Mechanism

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Solution Overview

Problem

Injection devices face challenges in maintaining dose accuracy and preventing damage from temperature-induced drug expansion, particularly when exposed to freezing conditions, which can lead to excessive force on the piston rod drive mechanism, potentially causing malfunction or breakage.

Innovation Solution

The injection device features a reversible movement mechanism allowing the actuation member and movable wall to displace in response to forces acting on the movable wall due to temperature changes, with a bias means for automatic return and a coupling mechanism that decouples under high forces to prevent damage, ensuring synchronized movements and maintaining dose accuracy.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If a unidirectional coupling mechanism is used to prevent slack between the piston rod and piston, then dose accuracy is improved, but the device becomes vulnerable to breakage when the drug freezes and expands

Engineering Contradiction:
Improvedose accuracyVSAvoiddevice reliability under freezing conditions
Core Design Contradiction:
Measurement precisionVSReliability

Solution Approach 1:

The coupling mechanism transitions from a rigid unidirectional coupling to a dynamic system with two-way coupling capability. The piston rod can couple with the piston during normal operation to ensure dose accuracy, and decouple when freezing forces exceed the retention force, allowing the system to adapt its coupling state based on operational conditions.

Inventive Principle:
Principle #15Dynamics

Solution Approach 2:

The system changes the coupling parameter dynamically - maintaining strong coupling under normal forces to ensure precision, and allowing decoupling when forces exceed a threshold (freezing conditions). The biasing element modifies the coupling parameter by applying a retention force that can be overcome by excessive expansion forces.

Inventive Principle:
Principle #35Parameter changes

2Manufacturing precision

If the piston rod is firmly coupled to the piston to eliminate slack, then injection accuracy is improved, but excessive force from frozen drug expansion can cause component breakage

Engineering Contradiction:
Improveinjection accuracyVSAvoidcomponent strength under expansion force
Core Design Contradiction:
Manufacturing precisionVSStrength

Solution Approach 1:

The biasing element (spring or elastomeric member) is pre-loaded to provide a retention force that maintains coupling during normal operation. This cushioning force ensures accurate coupling during injection while allowing the system to safely decouple when freezing forces exceed the pre-set retention threshold, preventing component breakage.

Inventive Principle:
Principle #11Beforehand cushioning (Prior cushioning)

Solution Approach 2:

The biasing element acts as an intermediary between the piston rod and piston, mediating the force transmission. It provides controlled retention force during normal operation and allows decoupling when forces become excessive, serving as a protective intermediary that prevents direct transmission of damaging forces to the components.

Inventive Principle:
Principle #24Intermediary (Mediator)

3Reliability

If a ratchet and pawl mechanism is used to prevent backward movement of the piston rod, then dose delivery reliability is improved, but the mechanism may break when subjected to large forces from frozen drug

Engineering Contradiction:
Improvedose delivery reliabilityVSAvoidcomplexity of coupling mechanism
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The invention extracts the one-way coupling function from a complex ratchet and pawl mechanism and implements it through a simpler biasing element that provides two-way coupling capability. The biasing element maintains coupling during normal operation and allows decoupling under excessive force, eliminating the need for complex ratchet and pawl components while maintaining reliability.

Inventive Principle:
Principle #2Taking out (Extraction)

4Reliability

If the piston rod drive mechanism is made robust to withstand freezing forces, then device reliability under freezing conditions is improved, but normal operation may be affected and dose accuracy may deteriorate

Engineering Contradiction:
Improvedevice reliability under freezing conditionsVSAvoiddose accuracy
Core Design Contradiction:
ReliabilityVSMeasurement precision

Solution Approach 1:

The coupling mechanism dynamically adjusts its state based on the forces involved. During normal operation, the biasing element maintains strong coupling for precise dose delivery. Under freezing conditions, when forces exceed the retention threshold, the system automatically decouples, allowing the piston to expand freely without affecting the precision of the drive mechanism.

Inventive Principle:
Principle #15Dynamics

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

This configuration ensures reliable and accurate administration of drug doses without damaging the injection mechanism, even when the drug expands due to freezing, by allowing reversible movement and automatic return of components, thus maintaining dose accuracy and preventing device failure.

Implementation Method 1

If an injection device accommodating a liquid drug is for any reason exposed to temperatures below the liquid drug's freezing point, the liquid will expand in the reservoir

Methodology Applied
Scientific EffectFreezing: Freezing

Implementation Method 2

the liquid will expand in the reservoir causing a relatively large pressure on the reservoir walls, including the piston

Methodology Applied
Scientific EffectThermal expansion: Thermal Expansion

Data Source

PatentUS9616175B2Frost protected injection device
Publication Date: 2017.04.11 NOVO NORDISK AS
  • US9616175B2 patent drawing
  • US9616175B2 patent drawing
  • US9616175B2 patent drawing

AI summary

The invention relates to an injection device (100, 200, 300) which is capable of resisting proximal movements of a piston rod (107, 207, 307) relative to a housing (102, 202, 302), when the piston rod (107, 207, 307) is subjected to proximally directed forces below a threshold magnitude, and of allowing reversible proximal movements of the piston rod (107, 207, 307) relative to the housing (102, 202, 302), when the piston rod (107, 207, 307) is subjected to proximally directed forces of or above the threshold magnitude.