Single-Use Cap with Elastomeric Sleeve for Needleless Connectors

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Solution Overview

Problem

Needleless connectors (NCs) contribute to catheter-related bloodstream infections (CRBSI) due to inadequate disinfection, leading to high treatment costs, prolonged hospital stays, and increased mortality, with existing disinfection guidelines being complex and prone to user errors, and single-use caps often being reused or improperly attached.

Innovation Solution

A single-use cap with an elastomeric sleeve releasably coupled to a carrier, designed to self-modify and prevent reuse by transferring to the connector head upon insertion, ensuring proper disinfection and preventing contamination through a sealing membrane and disinfectant applicator.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If complex disinfection guidelines are implemented, then disinfection effectiveness is improved, but user compliance deteriorates due to complexity and prone to errors

Engineering Contradiction:
Improvedisinfection effectivenessVSAvoiduser compliance
Core Design Contradiction:
ReliabilityVSEase of operation

Solution Approach 1:

The single-use cap system performs disinfection automatically through the transfer mechanism. The elastomeric sleeve with integrated disinfectant applicator self-applies disinfectant to the connector head during the transfer process, eliminating the need for users to manually disinfect the connector head separately. This self-service approach maintains high disinfection effectiveness while greatly simplifying user operation.

Inventive Principle:
Principle #25Self-service

Solution Approach 2:

The invention combines multiple functions into a single integrated cap system: the elastomeric sleeve serves as both the sealing component and the disinfectant delivery mechanism. The disinfectant applicator is integrated into the sleeve structure, merging disinfection function with the cap's primary sealing and transfer functions. This consolidation ensures disinfection is performed as an inherent part of the cap application process, improving both reliability and ease of use.

Inventive Principle:
Principle #5Merging (Combining)

2Ease of operation

If single-use caps are designed to be simple, then ease of operation is improved, but risk of reuse deteriorates

Engineering Contradiction:
Improvecap application simplicityVSAvoidprevent reuse capability
Core Design Contradiction:
Ease of operationVSReliability

Solution Approach 1:

The elastomeric sleeve is designed as a disposable component that is transferred to and remains on the connector head after use. The sleeve incorporates a destrucible link mechanism that prevents removal and reuse. By designing the cap's critical sealing component as a single-use disposable item with built-in anti-reuse features, the system maintains simplicity while ensuring reliability through prevention of reuse.

Inventive Principle:
Principle #27Cheap short-living objects (Disposable)

Solution Approach 2:

The destrucible link is pre-configured in the elastomeric sleeve to break during the transfer process. This preliminary design feature ensures that once the cap is applied, the connector head cannot be recapped with the same sleeve. The anti-reuse mechanism is built into the structure before use, requiring no additional user action or complex procedures to prevent reuse.

Inventive Principle:
Principle #10Preliminary action

3Adaptability or versatility

If elastomeric sleeve is releasably coupled to carrier, then transferability is improved, but risk of improper attachment deteriorates

Engineering Contradiction:
Improvetransfer capabilityVSAvoidproper attachment assurance
Core Design Contradiction:
Adaptability or versatilityVSReliability

Solution Approach 1:

The elastomeric sleeve's releasable coupling mechanism is designed to transfer automatically when the cap is properly applied to the connector head. The mechanical interaction between the sleeve and carrier during insertion causes the sleeve to release from the carrier and attach to the connector head without requiring separate user actions. This self-service transfer process ensures proper attachment while maintaining the necessary adaptability for transfer.

Inventive Principle:
Principle #25Self-service

Solution Approach 2:

The releasable coupling mechanism provides mechanical feedback during the transfer process. As the cap is applied, the sleeve experiences specific forces and movements that trigger the release from the carrier. This feedback mechanism ensures the transfer occurs only under the correct conditions, providing assurance of proper attachment while enabling the necessary transfer functionality.

Inventive Principle:
Principle #23Feedback

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 effectively reduces the risk of CRBSI by ensuring proper disinfection and preventing reuse of the elastomeric sleeve, enhancing compliance with disinfection protocols and reducing the risk of pathogen ingress, thereby decreasing treatment costs and mortality rates.

Implementation Method 1

an elastomeric sleeve releasably coupled to the carrier to span the opening

Methodology Applied
Scientific EffectElasticity: Elasticity

Data Source

PatentUS12017034B2Single use cap with sleeve and carrier for needleless connectors
Publication Date: 2024.06.25 QUEST MEDICAL INC
  • US12017034B2 patent drawing
  • US12017034B2 patent drawing
  • US12017034B2 patent drawing

AI summary

A single use cap for connectors and corresponding method of use. The single use cap has a carrier with a body including a base that defines an opening separated from an end wall by a side wall. The opening leads into a cavity sized to receive a connector head. The single use cap also has an elastomeric sleeve releasably coupled to the carrier to span the opening. The elastomeric sleeve is configured to be transferred to the connector upon insertion of the head through the opening and at least partially into the cavity.