Variable Piston Force Drug Delivery Drive Mechanism

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Solution Overview

Problem

Current drug delivery devices, particularly pen-type devices, lack the ability to efficiently manage variable doses, especially for users without formal medical training, such as diabetic patients, and often require higher forces for initial dispensing due to bung stiction, which can be challenging and inefficient.

Innovation Solution

A drug delivery device with a housing that houses a cartridge and a drive mechanism, featuring a bung that is movably retained within the cartridge, and a drive mechanism that adjusts the maximal driving force based on the bung's position and the cartridge's filling level, providing an initial higher force to overcome stiction and then reducing it for subsequent doses, utilizing a combination of energy storage and supplemental storage members to assist in dispensing.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Extent of automation

If a spring-driven mechanism is used to dispense drug doses, then the device can operate automatically without manual force application, but the initial stiction force required to move the bung from rest is excessively high, causing unreliable dose delivery

Engineering Contradiction:
Improveautomatic dose dispensingVSAvoidinitial stiction force
Core Design Contradiction:
Extent of automationVSForce

Solution Approach 1:

The patent applies dynamics by making the spring stiffness variable rather than constant. The spring mechanism transitions from a stiff initial state to a more compliant state as the bung moves, allowing high initial force to overcome stiction, then reducing force for the remainder of the stroke. This dynamic adjustment resolves the contradiction between automatic operation and excessive initial force requirements.

Inventive Principle:
Principle #15Dynamics

Solution Approach 2:

The patent changes the physical parameter of spring stiffness during operation. By using a progressive spring mechanism where the effective spring constant varies with displacement, the system provides high force when needed (at startup to overcome stiction) and lower force afterward. This parameter change directly addresses the force contradiction while maintaining automation.

Inventive Principle:
Principle #35Parameter changes

2Reliability

If a high force is applied to overcome initial bung stiction, then the device can reliably start dispensing, but the excessive force causes discomfort and difficulty for users without medical training

Engineering Contradiction:
Improvedose dispensing reliabilityVSAvoiduser effort
Core Design Contradiction:
ReliabilityVSEase of operation

Solution Approach 1:

The patent replaces the simple mechanical spring system with a progressive spring mechanism that intelligently modulates force output. This substitution maintains the mechanical advantage of spring-driven automation while eliminating the disadvantage of excessive user-applied force. The progressive spring automatically adjusts force levels, ensuring reliable Bung movement without requiring high user effort.

Inventive Principle:
Principle #28Mechanics substitution (Replace mechanical system)

Solution Approach 2:

By implementing dynamic force adjustment through the progressive spring mechanism, the system delivers high force only when necessary (to overcome stiction) and reduces force afterward. This dynamic behavior resolves the contradiction between reliability (needing high initial force) and ease of operation (needing low user effort).

Inventive Principle:
Principle #15Dynamics

3Device complexity

If a fixed spring preload is used to drive the bung, then the device structure is simple, but the force applied to the bung cannot be adjusted for different filling levels, leading to inefficient dispensing

Engineering Contradiction:
Improvedrive mechanism structureVSAvoiddispensing efficiency
Core Design Contradiction:
Device complexityVSProductivity

Solution Approach 1:

The patent implements parameter changes by making the spring stiffness variable rather than fixed. The progressive spring mechanism automatically adjusts the effective spring constant based on the bung position and cartridge filling level. This allows the system to optimize force application for different dosing scenarios without requiring complex external control systems, thus maintaining relatively simple structure while improving dispensing efficiency.

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The progressive spring mechanism introduces dynamic adaptability to the drive system. Rather than a fixed preload, the spring characteristics change during operation to match the varying resistance encountered at different filling levels. This dynamic adjustment improves productivity by ensuring optimal force is applied throughout the dispensing process while keeping the overall device structure manageable.

Inventive Principle:
Principle #15Dynamics

4Device complexity

If manual force application is required to dispense each dose, then the device structure is simple, but users without medical training cannot reliably select and administer variable doses

Engineering Contradiction:
Improvedose setting mechanismVSAvoiddose selection and administration
Core Design Contradiction:
Device complexityVSEase of operation

Solution Approach 1:

The progressive spring mechanism enables self-service operation by automatically providing the necessary force variations throughout the dispensing process. Users simply need to initiate the process, and the system self-adjusts the force profile to overcome stiction and complete the dose delivery. This eliminates the need for users to manually manage complex force application while maintaining relatively simple device structure.

Inventive Principle:
Principle #25Self-service

Solution Approach 2:

The patent replaces manual force management with an automated progressive spring mechanism. This substitution maintains mechanical simplicity while dramatically improving ease of operation for variable dose administration. Users no longer need to understand or control the force profile; the progressive spring handles this automatically, making the device accessible to non-medical users.

Inventive Principle:
Principle #28Mechanics substitution (Replace mechanical system)

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

Enables user-friendly, efficient dispensing of variable drug doses with reduced user effort and increased accuracy by adjusting the driving force according to the bung's position and cartridge filling level, effectively addressing the initial stiction challenge and ensuring consistent dispensing throughout the device's operation.

Implementation Method 1

devices which are driven by a spring or the like

Methodology Applied
Scientific EffectSpring: Spring

Implementation Method 2

utilizing a combination of energy storage and supplemental storage members to assist in dispensing

Methodology Applied
Scientific EffectEnergy storage: Mechanical Accumulator

Data Source

PatentEP3223884B1Drug delivery device with variable piston force
Publication Date: 2023.05.10 SANOFI SA(FR)
  • EP3223884B1 patent drawingFigure 1~3
  • EP3223884B1 patent drawingFigure 4a~5
  • EP3223884B1 patent drawingFigure 6~8

AI summary

The present disclosure relates to a drug delivery device, comprising a housing (10), a cartridge (100), the cartridge containing a drug in a quantity sufficient for a plurality of doses of the drug, a bung (101 ), the bung being movably retained within the cartridge to dispense a dose of the drug from the cartridge upon movement of the bung with respect to the cartridge, and a drive mechanism (30), the drive mechanism being operable to transfer a driving force to the bung to dispense the dose of the drug from the cartridge, wherein the drug delivery device is configured such that the maximal driving force which is transferable to the bung via the drive mechanism varies and is adjusted to the current position of the bung within the cartridge.