Tamper-Indicating Catheter Connector Housing With Frangible Seal

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Solution Overview

Problem

Existing medical catheters are vulnerable to accidental and unauthorized access via needleless connectors, leading to potential infections and drug abuse, with no effective means to ensure the integrity and tamper evidence of these connectors.

Innovation Solution

A protection device comprising an inner and outer housing with a tamper indicating assembly, where the inner housing is securely received within the outer housing, and upon removal, a frangible member breaks to indicate tampering, ensuring visual evidence of unauthorized access.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of operation

If needleless connectors are made easily accessible for catheter access, then ease of operation is improved, but vulnerability to accidental and unauthorized access increases

Engineering Contradiction:

Improvecatheter accessVSAvoidunauthorized access

Core Design Contradiction:

Ease of operationVSObject-affected harmful factors

Solution Approach 1:

The protection device employs a nested structure with an outer housing containing an inner housing, where the medical article is received in the inner housing which is itself received in the outer housing. This nested configuration provides multiple layers of protection while maintaining controlled access to the needleless connector through the port interface.

Inventive Principle:

Principle #7Nested doll (Nesting)

Solution Approach 2:

The protection device is pre-assembled with the medical article before use, with the inner housing already containing the needleless connector and the outer housing providing initial protection. The tamper-indicating assembly is pre-configured to detect any unauthorized manipulation attempts before the device is actually used.

Inventive Principle:

Principle #10Preliminary action

2Reliability

If protection devices are designed to prevent unauthorized access, then reliability is improved, but device complexity increases

Engineering Contradiction:

Improveintegrity of needleless connectorVSAvoidstructure of protection device

Core Design Contradiction:

ReliabilityVSDevice complexity

Solution Approach 1:

The protection device is divided into distinct functional segments: an outer housing for initial protection and transport, an inner housing for securing the medical article, a tamper-indicating assembly for detecting unauthorized access, and a port interface for controlled catheter access. This segmentation allows each component to perform its specific function efficiently while maintaining overall system reliability.

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The tamper-indicating assembly serves as an intermediary mechanism between the protective housing structure and the needleless connector. It detects unauthorized manipulation attempts and provides visual indication without directly interfering with the normal function of the needleless connector when accessed through the designated port interface.

Inventive Principle:

Principle #24Intermediary (Mediator)

3Difficulty of detecting and measuring

If tamper indicating mechanisms are added to detect unauthorized access, then ability to detect tampering is improved, but device complexity increases

Engineering Contradiction:

Improvetampering detectionVSAvoidtamper indicating assembly

Core Design Contradiction:

Difficulty of detecting and measuringVSDevice complexity

Solution Approach 1:

The tamper-indicating assembly utilizes color changes or visual indicators to signal unauthorized access attempts. When the inner housing is removed from the outer housing or when unauthorized access is attempted, the tamper-indicating mechanism displays a visible change (such as a color change or exposed indicator) that clearly indicates tampering has occurred, making detection straightforward without complex electronics.

Inventive Principle:

Principle #32Color changes

4Reliability

If the protection device securely retains the medical article, then reliability is improved, but ease of operation decreases

Engineering Contradiction:

Improvesecure retentionVSAvoidaccess to needleless connector

Core Design Contradiction:

ReliabilityVSEase of operation

Solution Approach 1:

The port interface is designed with multi-functionality, serving both as a secure closure that maintains the integrity of the needleless connector and as a controlled access point for authorized catheter connections. The same port structure provides both protection and functional access, eliminating the need for separate mechanisms and maintaining ease of operation for authorized users.

Inventive Principle:

Principle #6Universality (Multi-functionality)

Data Source

PatentUS20250381382A1Protection device for medical article

Publication Date: 2025.12.18 SOLVENTUM INTELLECTUAL PROPERTIES CO

AI summary

A protection device for a medical article is disclosed. The protection device includes an inner housing including a socket disposed at a second inner end thereof, an outer housing, and a tamper indicating assembly disposed proximal to a second outer end of the outer housing. The tamper indicating assembly includes body including a breaking member, and an indicator including an engagement member and a frangible member coupled to the engagement member. Upon at least partially receiving the inner housing within the outer housing, the socket at least partially receives and retains the engagement member therein, such that the engagement member is secured to the inner housing. Upon removal of the inner housing from the outer housing, the breaking member breaks the frangible member. A breakage of the frangible member is indicative of tampering with the protection device.