Medicament Stopper With Cold-Flowable Polymer Self-Sealing

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Solution Overview

Problem

Conventional stoppers for medicament containers are not self-sealing and resealable after needle penetration, leading to compromised sterility and single-use limitations, resulting in unnecessary disposal of costly and unused medicaments.

Innovation Solution

A stopper comprising a hollow shell with an outer layer of substantially solid polymer and an inner layer of cold-flowable polymer, which deforms to allow needle insertion and reforms to seal the path upon withdrawal, enabling multiple uses of medicament containers.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of operation

If a conventional rubber stopper is used to allow needle penetration for medicament extraction, then the stopper provides good closing properties and chemical resistance, but the puncture creates a permanent path for microorganisms and contaminants to enter the sterile container, compromising sterility

Engineering Contradiction:
Improveneedle penetration capabilityVSAvoidmicroorganism and contaminant entry
Core Design Contradiction:
Ease of operationVSObject-affected harmful factors

Solution Approach 1:

The patent changes the physical state of the stopper material from permanently elastic (conventional rubber) to temporarily deformable. The cold-flowable polymer undergoes a parameter change in its flow properties: it deforms plastically under needle insertion stress but then flows back to seal the puncture path when the needle is removed, eliminating permanent contamination pathways while maintaining ease of needle penetration.

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The invention uses a composite material system combining a solid polymer matrix with a cold-flowable polymer component. This composite structure integrates the structural integrity needed for needle penetration with the self-sealing capability to prevent microorganism entry, resolving the contradiction between operational ease and contamination prevention.

Inventive Principle:
Principle #40Composite materials

2Object-affected harmful factors

If a conventional stopper is designed for single-use to maintain sterility after needle penetration, then contamination is prevented, but the container must be discarded even when medicament remains, leading to waste of costly and limited quantities of medicament

Engineering Contradiction:
Improvesterility maintenanceVSAvoidunused medicament disposal
Core Design Contradiction:
Object-affected harmful factorsVSLoss of substance

Solution Approach 1:

The stopper performs self-service by automatically sealing the puncture path after needle removal without requiring external intervention. The cold-flowable polymer spontaneously flows to close the gap created by needle penetration, enabling the container to maintain sterility and remain reusable multiple times, thereby preventing waste of unused medicament while preserving sterility.

Inventive Principle:
Principle #25Self-service

Solution Approach 2:

The patent introduces dynamic behavior to the stopper material, which transitions from a rigid, permanently punctured state to a dynamic self-healing state. The cold-flowable polymer dynamically responds to needle insertion and removal by deforming and then flowing back to seal the path, enabling multiple uses while maintaining sterility and preventing medicament waste.

Inventive Principle:
Principle #15Dynamics

3Productivity

If a hollow needle is inserted through a conventional rubber stopper to extract medicament, then the needle pathway may become blocked or cored, but with proper stopper design, efficient extraction is achieved, yet the stopper cannot be reused

Engineering Contradiction:
Improvemedicament extraction efficiencyVSAvoidstopper reusability
Core Design Contradiction:
ProductivityVSDuration of action of stationary object

Solution Approach 1:

The patent applies parameter changes to the stopper material's flow characteristics, allowing it to temporarily deform during needle insertion for efficient medicament extraction, then automatically return to its original sealed state. This enables the stopper to maintain extraction efficiency across multiple uses by preventing pathway blockage and corrosion through its self-sealing cold-flowable polymer structure.

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

The stopper provides a hermetically sealed and reusable medicament container, preventing contamination and allowing multiple doses from a single container, thereby reducing waste and ensuring sterility.

Implementation Method 1

The cold-flowable polymer is deformable when an object, such as a needle, is inserted therein thereby forming a gap or fractured path

Methodology Applied
Scientific EffectCold-flowable deformation: Plasticity

Implementation Method 2

is capable of reforming to its original shape and/or seal the fractured path when the object is removed

Methodology Applied
Scientific EffectElastic recovery: Elastic Recovery

Data Source

PatentUS10449117B2Stopper for medicament containers
Publication Date: 2019.10.22 Q MEDICAL LLC
  • US10449117B2 patent drawing
  • US10449117B2 patent drawing
  • US10449117B2 patent drawing

AI summary

A stopper is generally provided in which a hollow shell includes at least one outer layer and an inner layer positioned within the outer layer. The outer layer is formed from a substantially solid polymer while the inner layer is formed from a cold-flowable polymer. The cold-flowable polymer is deformable when an object is inserted therein and is scalable when the object is removed.