Magnetic Pseudo Sample for Drug-Delivery Cap Force Validation
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Solution Overview
Problem
Existing test methods for measuring cap removal force in drug delivery devices lack reliability and repeatability, leading to potential user difficulties in accessing medication and increased risk of accidental needle sticks or premature fluid expulsion.
Innovation Solution
A pseudo sample is developed with adjustable magnets within the drug delivery device to simulate a standard cap removal force, allowing for precise adjustment and validation of test methods by altering the distance between magnets to achieve a desired cap removal force.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If magnets are used to simulate cap removal force, then measurement precision and repeatability are improved, but device complexity increases
Solution Approach 1:
The patent creates a pseudo sample that copies the essential functional characteristics of a real drug delivery device cap assembly. By replicating only the critical magnetic interaction components (magnet in cap, magnet in body) without including all device components, it achieves a simplified model that still provides valid measurement of cap removal force. This selective copying resolves the contradiction by maintaining measurement precision while reducing unnecessary complexity.
Solution Approach 2:
The patent utilizes magnetic field parameters (strength, distance) to control and standardize cap removal force. By adjusting the position or strength of magnets, the cap removal force can be precisely controlled to match target values. This parameter-based control improves measurement repeatability and precision while providing a systematic approach to managing the device complexity through adjustable parameters rather than fixed complex mechanisms.
2Reliability
If adjustable magnets are implemented to control cap removal force, then reliability is improved, but ease of manufacture deteriorates
Solution Approach 1:
The patent implements an adjustable magnet position mechanism that allows the magnetic components to be moved to different positions within the pseudo sample body. This dynamic adjustment capability enables precise control over cap removal force to ensure reliable test method validation. The adjustability is achieved through simple mechanical means (slots, guides, or movable mounts) rather than complex mechanisms, balancing reliability improvement with manufacturing ease.
Solution Approach 2:
The patent incorporates magnets and adjustment mechanisms during the pseudo sample manufacturing process itself, rather than requiring post-manufacturing calibration or assembly. The magnets are positioned and secured in predetermined locations during fabrication, and the adjustment capability is built into the structure from the outset. This preliminary action approach improves reliability by ensuring consistent initial conditions while simplifying the overall manufacturing process.
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 pseudo sample provides a quantifiable, repeatable, and reproducible force for validating test methods, ensuring consistent cap removal forces and reducing the risk of device failure or user error.
Implementation Method 1
an attraction between the upper magnet and the cap magnet is configured to deliver a standard force required to remove the cap from the body of the drug delivery device
Data Source
AI summary
Disclosed herein are a pseudo sample configured for validating the test method of measuring a force required to remove a cap from a drug delivery device, wherein the pseudo sample comprises an upper magnet movably secured within a body of the drug delivery device; and a cap magnet secured within the cap, wherein an attraction between the upper magnet and the cap magnet is configured to deliver a standard force required to remove the cap from the body of the drug delivery device. Also disclosed herein are methods of assembling such a pseudo sample, and methods of using such a pseudo sample to validate the test method of measuring a force required to remove a cap from a drug delivery device.