Separable Infusion Set With Rotatable Cap And Self-Sealing Septum

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Solution Overview

Problem

Existing infusion sets face challenges such as difficulty in assembly, poor seal integrity, unidirectional extension tubing, and increased risk of infection due to hidden insertion sites, making them cumbersome and prone to contamination.

Innovation Solution

The infusion set design incorporates a self-sealing septum, a rotatable cap assembly, and a latching mechanism that allows for easy alignment and secure attachment of the cap and base, enabling flexible tubing orientation and improved visibility of the insertion site, thereby reducing the risk of infection and leakage.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of operation

If the cap and base are made separable for easy assembly and disassembly, then the ease of operation is improved, but the reliability of the seal may deteriorate

Engineering Contradiction:
Improveease of assemblyVSAvoidseal integrity
Core Design Contradiction:
Ease of operationVSReliability

Solution Approach 1:

The septum is pre-installed in the base with a self-sealing design that automatically seals when the cap is attached or detached. This preliminary preparation ensures that the seal is already in place and functional before the actual connection is made, eliminating the need for complex sealing operations during assembly and disassembly.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The self-sealing septum automatically seals itself when the cap is attached or detached without requiring additional sealing actions or components. The septum's material properties and design allow it to maintain seal integrity through the repeated attachment and detachment cycles, making the system self-sufficient for sealing operations.

Inventive Principle:
Principle #25Self-service

2Device complexity

If the extension tubing is fixed in a unidirectional orientation, then the device complexity is reduced, but the adaptability deteriorates

Engineering Contradiction:
Improvestructural simplicityVSAvoidtubing orientation flexibility
Core Design Contradiction:
Device complexityVSAdaptability or versatility

Solution Approach 1:

The cap assembly is designed to rotate freely on the base, transforming the fixed, static orientation into a dynamic, adjustable configuration. This rotational freedom allows the extension tubing to be repositioned to various angles and directions while maintaining a relatively simple base structure, thus achieving adaptability without proportionally increasing complexity.

Inventive Principle:
Principle #15Dynamics

3Device complexity

If the insertion site is hidden from view, then the device complexity is reduced, but the object-affected harmful factors increase

Engineering Contradiction:
Improvestructural simplicityVSAvoidinfection risk
Core Design Contradiction:
Device complexityVSObject-affected harmful factors

Solution Approach 1:

The base incorporates a transparent or translucent window that allows visual inspection of the insertion site. This optical property change enables users to monitor the insertion site for signs of infection or complications without adding complex mechanical inspection devices, thus reducing harmful factors while maintaining structural simplicity.

Inventive Principle:
Principle #32Color changes

4Reliability

If the cap is difficult to remove and re-attach, then the reliability of the connection is improved, but the ease of operation deteriorates

Engineering Contradiction:
Improveconnection stabilityVSAvoidcap removal and re-attachment
Core Design Contradiction:
ReliabilityVSEase of operation

Solution Approach 1:

The cap and base are designed with pre-aligned attachment features and a self-latching mechanism that automatically engages when the cap is placed on the base. This preliminary configuration ensures proper alignment and secure connection without requiring complex manual adjustment or forcing actions, making the cap easy to remove and re-attach while maintaining reliable connection.

Inventive Principle:
Principle #10Preliminary action

Data Source

PatentEP3372272B1Separatable infusion set with cleanable interface and straight line attachment
Publication Date: 2024.11.20 BECTON DICKINSON & CO
  • EP3372272B1 patent drawingFigure 1~2A
  • EP3372272B1 patent drawingFigure 2B
  • EP3372272B1 patent drawingFigure 2C~2D

AI summary

Infusion sets for insertion into an insertion site for prevent-ing misalignment of the base and cap or fluid connector by providing one or more alignment features between each, and in alternative embodiments, provide one or more features to secure the cap or fluid connector to the base in anyone of a number of rotational positions and having release features to allow the cap or fluid connector to be rotatable with respect to the base portion of the infusion set, and yet easily removed and inserted. Further embodiments provide infusion sets wherein the user can easily see the insertion site of the catheter and the skin, to determine if infections have occurred at an earlier stage than was possible using prior art infusion sets and with substantially less difficulty.