Tamper Evident Closure Assembly With Frangible Attachment

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Solution Overview

Problem

Current tamper-evident solutions for medical tubing fittings, such as shrink bands, are time-consuming to install, prone to quality issues, and leave remnants on the fitting, while existing rigid solutions do not provide effective tamper indication without physical remnants.

Innovation Solution

A tamper-evident closure assembly with an integral cap, collar, and frangible attachment, featuring internally-directed threads, externally-directed splines, and a coaxial post, which forms a fluid seal and indicates tampering by severing when removed.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If shrink bands are used for tamper evidence, then tamper indication is achieved, but installation time increases and quality issues arise

Engineering Contradiction:
Improvetamper indication reliabilityVSAvoidinstallation time
Core Design Contradiction:
ReliabilityVSLoss of time

Solution Approach 1:

The patent combines the cap and collar into a single integral unit with a frangible attachment, eliminating the need for separate shrink band application and heat shrinking processes. This merging of components achieves tamper indication while reducing installation time and eliminating secondary operations.

Inventive Principle:
Principle #5Merging (Combining)

Solution Approach 2:

The integral unit is designed with a frangible attachment that can segment into separate cap and collar portions when tampering occurs. This segmentation provides clear tamper evidence while maintaining the integrity of the sealing function during normal use.

Inventive Principle:
Principle #1Segmentation

2Reliability

If rigid tamper evident features are used, then tamper indication is provided, but remnants are left on the fitting

Engineering Contradiction:
Improvetamper indicationVSAvoidremnants on fitting
Core Design Contradiction:
ReliabilityVSObject-generated harmful factors

Solution Approach 1:

The frangible attachment is designed to dynamically separate into cap and collar portions when tampering forces are applied. This dynamic separation ensures that no permanent remnants are left on the fitting, unlike rigid tamper evident features that remain as debris.

Inventive Principle:
Principle #15Dynamics

3Reliability

If shrink bands with perforations are used, then tamper evidence is achieved, but manufacturing quality varies

Engineering Contradiction:
Improvetamper evidenceVSAvoidperforation uniformity
Core Design Contradiction:
ReliabilityVSManufacturing precision

Solution Approach 1:

The patent changes the physical state and properties of the frangible attachment to create a controlled weakness that severs predictably. Instead of relying on perforation uniformity, the frangible attachment uses material property changes and geometric design to ensure consistent tamper indication with high manufacturing precision.

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

Provides a reliable and efficient tamper-evident mechanism that maintains sterility and prevents remnants on the fitting, allowing immediate detection of tampering without secondary operations or quality issues.

Implementation Method 1

Tampering with the integral unit when the integral unit is applied to the fitting severs the frangible attachment, thereby defining the cap and collar as separate pieces

Methodology Applied
Scientific EffectFracture Mechanics: Fracture Mechanics

Implementation Method 2

the post and the cap form a fluid seal

Methodology Applied
Scientific EffectFluid Seal:

Data Source

PatentUS10780259B2Tamper evident closure assembly
Publication Date: 2020.09.22 BIOQ PHARMA INC
  • US10780259B2 patent drawing
  • US10780259B2 patent drawing
  • US10780259B2 patent drawing

AI summary

A tamper evident closure assembly is for use with a fitting having an outer sidewall with internally-directed threads, externally-directed splines, and an open post. The closure assembly includes a cap, a collar, and a frangible attachment coupling the cap and collar. The cap, collar, and frangible attachment are formed integrally as an integral unit. A radial lug on the cap engages with the fitting threads. A pawl on the collar allows rotation of the integral unit on the fitting in a first rotational direction and prevents rotation in a second rotational direction. Application of the integral unit to the fitting engages the radial lug with the threads on the fitting and the post and the cap form a fluid seal. Tampering with the integral unit when the integral unit is applied to the fitting severs the frangible attachment, thereby defining the cap and collar as separate pieces.