Flexible Retaining Member for Medical Dispenser Tamper Evidence

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Solution Overview

Problem

Current medical dispenser closure systems fail to provide a secure and reliable fluid sealing connection, are prone to tampering, and require complex and costly production techniques, while also lacking versatility across different connectors and devices.

Innovation Solution

A closure assembly featuring a cover with a flexible retaining member, comprising angularly oriented flexible fingers, which establishes a frictional interference fit with the tip cap and discharge port, preventing reinsertion and ensuring tamper evidence through a flexible, ductile material structure that maintains integrity during removal and use.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If conventional closure systems are used, then the device structure is simple, but the fluid sealing connection is not secure and reliable

Engineering Contradiction:

Improvefluid sealing connectionVSAvoidclosure system structure

Core Design Contradiction:

ReliabilityVSDevice complexity

Solution Approach 1:

The closure system employs a flexible retaining member with fingers that can dynamically change position - initially disposed to allow tip cap removal, then repositioned to prevent reinsertion. This dynamic behavior provides secure fluid sealing while maintaining relatively simple structure.

Inventive Principle:

Principle #15Dynamics

Solution Approach 2:

The retaining member is constructed from flexible material that can bend and deform to accommodate the tip cap during normal operations, then flex into a blocking position to prevent reinsertion. This flexibility enables reliable sealing without complex mechanical components.

Inventive Principle:

Principle #30Flexible shells and thin films

2Object-affected harmful factors

If tamper-proof mechanisms are added, then the protection against unauthorized access is improved, but the device complexity increases

Engineering Contradiction:

Improvetamper resistanceVSAvoidclosure assembly structure

Core Design Contradiction:

Object-affected harmful factorsVSDevice complexity

Solution Approach 1:

The flexible retaining member is pre-configured in an initial position that allows normal tip cap removal. After removal, the member automatically or manually repositions to a blocking configuration that prevents reinsertion, providing tamper evidence without requiring complex additional mechanisms.

Inventive Principle:

Principle #10Preliminary action

Solution Approach 2:

Instead of using complex locks or seals to prevent removal, the system allows removal but then uses the flexible retaining member to invert the situation - blocking reinsertion. This simpler approach provides equivalent tamper protection.

Inventive Principle:

Principle #13The other way round (Inversion)

3Manufacturing precision

If complex production techniques are used, then the manufacturing precision is improved, but the production cost and complexity increase

Engineering Contradiction:

Improveclosure assembly precisionVSAvoidproduction process simplicity

Core Design Contradiction:

Manufacturing precisionVSEase of manufacture

Solution Approach 1:

The flexible retaining member utilizes material flexibility as a key parameter, allowing it to assume different configurations (initial position for removal, blocking position for prevention) without requiring complex manufacturing processes. This approach achieves precise functionality through material properties rather than complex geometry.

Inventive Principle:

Principle #35Parameter changes

4Object-affected harmful factors

If a secure closure system is implemented, then the protection against contamination is improved, but the ease of operation decreases

Engineering Contradiction:

Improvecontamination protectionVSAvoidtip cap removal and reinsertion

Core Design Contradiction:

Object-affected harmful factorsVSEase of operation

Solution Approach 1:

The flexible retaining member dynamically adapts its configuration based on operational needs - initially allowing easy tip cap removal for sterile access, then transitioning to a blocking position that prevents reinsertion and maintains contamination protection. This dynamic behavior balances ease of operation with security.

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

The solution provides a secure, fluid-sealing connection that prevents unauthorized access and reinsertion, reduces production complexity, and enhances cost-effectiveness while maintaining structural reliability across various medical devices.

Implementation Method 1

establishes a frictional interference fit with the tip cap and discharge port

Methodology Applied

Scientific EffectFriction: Friction

Implementation Method 2

flexible, ductile material structure that maintains integrity during removal and use

Methodology Applied

Scientific EffectElasticity: Elasticity

Data Source

PatentUS11793987B1Flex tec closure assembly for a medical dispenser

Publication Date: 2023.10.24 MEDICAL DEVICE ENGINEERING LLC

AI summary

A closure assembly for a medical dispenser including a cover and a tip cap removably disposed therein. A flexible retaining member including a plurality of flexible fingers is/are angularly positioned within the cover in both a retaining relation and a blocking position, which respectively restrict removal of the tip cap from the cover and a reinsertion of the tip cap, back into the cover, subsequent to its removal. Structurally distinguishable but similarly operable embodiments include the plurality of flexible fingers connected to and extending angularly outward from an interior of the cover or connected to an exterior of the tip cap.