Needleless Connector Sealing Device with Collapsible Neck

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Solution Overview

Problem

Needleless connectors (NCs) in medical settings are a cause of catheter-related bloodstream infections (CRBSI) due to inadequate disinfection, leading to high treatment costs, prolonged hospital stays, and increased mortality, with current disinfection guidelines being complex and prone to user error, and single-use caps often being reused or not used properly.

Innovation Solution

A sealing device with a head and neck that expands to accommodate a needleless connector, featuring a disinfectant applicator and a spacer that maintains the expanded configuration, preventing reuse by collapsing when the connector is removed, ensuring effective sealing and disinfection prior to use.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If current disinfection guidelines are followed, then disinfection effectiveness is improved, but device complexity and user error increase

Engineering Contradiction:
Improvedisinfection effectivenessVSAvoiddisinfection protocol complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The sealing device is pre-configured with a spacer that maintains the neck in an expanded configuration during storage and transport. This preliminary action ensures that when the device is first used, the aperture is already in the optimal expanded state for sealing, eliminating the need for users to manually expand it and reducing steps in the disinfection protocol.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The neck of the sealing device is designed to dynamically change between expanded and collapsed configurations. The spacer maintains the expanded configuration during storage, and when the apparatus is removed, the neck automatically collapses to a smaller diameter. This dynamic behavior simplifies the disinfection process by automatically adapting to the sealing and post-removal states.

Inventive Principle:
Principle #15Dynamics

2Object-affected harmful factors

If single-use caps are used, then contamination prevention is improved, but reuse and improper use occur

Engineering Contradiction:
Improvecontamination preventionVSAvoidproper usage compliance
Core Design Contradiction:
Object-affected harmful factorsVSEase of operation

Solution Approach 1:

The neck's dynamic collapse from expanded to collapsed configuration after apparatus removal provides a mechanical indication that the device has been used. This physical change makes it immediately apparent that the sealing device should not be reused, thereby preventing improper reuse while maintaining ease of operation during the initial sealing function.

Inventive Principle:
Principle #15Dynamics

Solution Approach 2:

The sealing device incorporates a visual indicator that changes appearance between used and unused states. This visual feedback mechanism makes it obvious whether the device has been previously used, preventing reuse and ensuring proper single-use compliance without complicating the operation for healthcare providers.

Inventive Principle:
Principle #32Color changes

3Reliability

If aperture diameter is increased, then sealing capability is improved, but device size increases

Engineering Contradiction:
Improvesealing capabilityVSAvoiddevice size
Core Design Contradiction:
ReliabilityVSArea of stationary object

Solution Approach 1:

The neck is designed to dynamically change diameter between expanded and collapsed states. During storage and initial use, the spacer maintains the neck in an expanded configuration with a larger aperture diameter for optimal sealing capability. After the apparatus is removed, the neck automatically collapses to a smaller diameter, reducing the overall device size and allowing for more compact storage and handling.

Inventive Principle:
Principle #15Dynamics

Solution Approach 2:

The collapsed configuration of the neck allows the sealing device to be more compact, essentially nesting the larger expanded structure into a smaller form factor when not in use. This enables the device to provide large aperture sealing capability when needed while maintaining a compact size for storage and transport.

Inventive Principle:
Principle #7Nested doll (Nesting)

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 sealing device effectively prevents contamination and disinfects needleless connectors before use, reducing the risk of CRBSI by ensuring proper sealing and disinfection, thereby decreasing hospital costs and mortality rates while simplifying disinfection protocols.

Implementation Method 1

The aperture is configured to collapse and expand, having a first diameter in a collapsed configuration and a second diameter in an expanded configuration

Methodology Applied
Scientific EffectElasticity: Elasticity

Implementation Method 2

The interior surface of the neck includes an engagement interface that is configured to releasably engage with a spacer

Methodology Applied
Scientific EffectMechanical Fastening: Mechanical Fastener

Data Source

PatentUS20230398344A1Sealing device for needleless connectors
Publication Date: 2023.12.14 QUEST MEDICAL INC
  • US20230398344A1 patent drawing
  • US20230398344A1 patent drawing
  • US20230398344A1 patent drawing

AI summary

A sealing device for sealing an opening of an apparatus. The sealing device has a head that defines a cavity and a neck that defines a passage disposed between the cavity at a first end of the neck and an aperture at a second end of the neck. The aperture is configured to collapse and expand, having a first diameter in a collapsed configuration and a second diameter in an expanded configuration. The interior surface of the neck includes an engagement interface that is configured to releasably engage with a spacer. When the engagement interface is engaged with the spacer, the neck is in the expanded configuration.