Deformable Luer Cap Seal for Sterility and Fluid Control

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Solution Overview

Problem

Central venous catheters are prone to infections due to exposure to foreign bodies, leading to increased hospital costs and morbidity, as existing solutions fail to effectively maintain sterility of medical connectors.

Innovation Solution

A cap for medical connectors featuring a disinfecting agent chamber with an insert that deforms to apply antiseptic fluid around the connector while minimizing fluid entry, configured to engage with both male and female luer connectors, and designed to maintain a seal during use and disengagement.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If a cap is used to protect the sterility of open medical connectors, then the risk of infections is reduced, but the cap may allow fluid leakage or fail to maintain effective disinfection

Engineering Contradiction:

Improvesterility maintenanceVSAvoidfluid leakage

Core Design Contradiction:

ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent employs a flexible membrane that forms a seal against the connector surface. This membrane is deformable to accommodate engagement forces while maintaining an effective barrier against fluid leakage, thus preserving sterility without compromising sealing integrity

Inventive Principle:

Principle #30Flexible shells and thin films

Solution Approach 2:

The membrane is designed to be dynamically deformable during cap engagement and disengagement. It flexes to allow connector insertion/removal while automatically returning to its sealed configuration, providing continuous protection against fluid leakage throughout the operational cycle

Inventive Principle:

Principle #15Dynamics

2Reliability

If an insert deforms to apply antiseptic fluid around the connector, then disinfection effectiveness is improved, but fluid may enter the connector lumen

Engineering Contradiction:

Improvedisinfection effectivenessVSAvoidfluid entry into lumen

Core Design Contradiction:

ReliabilityVSObject-generated harmful factors

Solution Approach 1:

The insert is designed with differentiated zones: an outer region that deforms to distribute antiseptic fluid around the connector exterior for effective disinfection, and an inner region that maintains structural integrity to prevent fluid from entering the connector lumen, thus achieving localized functional optimization

Inventive Principle:

Principle #3Local quality

3Adaptability or versatility

If the cap is designed to engage with both male and female luer connectors, then versatility is improved, but device complexity increases

Engineering Contradiction:

Improveconnector compatibilityVSAvoidcap design complexity

Core Design Contradiction:

Adaptability or versatilityVSDevice complexity

Solution Approach 1:

The cap incorporates a universal engagement mechanism with opposing threads that can interface with both male and female luer connectors. This single design achieves multi-functionality by adapting its engagement mode based on the connector type, eliminating the need for separate caps for different connector genders

Inventive Principle:

Principle #6Universality (Multi-functionality)

4Reliability

If the insert exerts force against the connector to maintain seal, then sealing effectiveness is improved, but the insert may damage the connector

Engineering Contradiction:

Improveseal effectivenessVSAvoidconnector integrity

Core Design Contradiction:

ReliabilityVSStrength

Solution Approach 1:

The insert material is selected with specific mechanical properties (durometer, elasticity) that allow it to exert sufficient sealing force against the connector surface while remaining compliant enough to prevent damage. The force parameters are optimized to achieve reliable sealing without exceeding the connector's structural tolerance

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 cap effectively reduces the risk of infections by applying antiseptic agents to medical connectors, minimizing fluid entry into the connectors, and maintaining sterility, thereby decreasing hospital-acquired infections and associated costs.

Implementation Method 1

the insert is configured to deform when a luer connector is engaged with the cap

Methodology Applied

Scientific EffectDeformation: Deformation

Implementation Method 2

The cap may include a seal configured to prevent the antiseptic fluid from entering the luer connector when the luer connector is engaged with the cap

Methodology Applied

Scientific EffectSealing:

Data Source

PatentUS11752318B2Disinfecting luer cap and method of use

Publication Date: 2023.09.12 MERIT MEDICAL SYSTEMS INC

AI summary

Medical devices including a cap for a medical connector are disclosed. In some embodiments, the cap comprises a disinfectant, such as an antiseptic fluid and an insert configured to seal or partially seal the medical connector as it is engaged with the cap. In some embodiments the cap insert has a segment which is deformable under axially applied pressure as an end-user attaches the cap to the medical connector. In some embodiments this insert is configured to improve the exposure of antiseptic to the outer surface of the medical connector while minimizing exposure of the antiseptic inside the medical connector open lumen.