Needle-Free Connector Pressure Regulation With Visual Indication

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Solution Overview

Problem

Existing infusion sets lack pressure regulation and indication capabilities, which are crucial for safe infusion therapy, particularly in conditions like chemotherapy, neonatal care, and power injection, to prevent hemolysis and bag breakage.

Innovation Solution

Development of adjustable needle-free connectors with integrated pressure regulation and indication features, utilizing elastomeric bellows, deformable valves, and visual indicators to manage fluid pressure within safe limits.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If typical needle-free connectors are used, then the device complexity is low and ease of operation is good, but pressure regulation capability is lacking and pressure indication is not provided

Engineering Contradiction:
Improvepressure regulation capabilityVSAvoidconnector structure complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The patent combines multiple functions (flow control, pressure regulation, and pressure indication) into a single needle-free connector assembly. The flow regulator valve integrates a bellows mechanism, plunger, and visual indicator system into one unified component that replaces what would traditionally be separate devices, thereby improving reliability while managing complexity through functional integration.

Inventive Principle:
Principle #5Merging (Combining)

Solution Approach 2:

The needle-free connector is designed to perform multiple functions simultaneously: it provides needle-free connection, flow regulation through the valve mechanism, pressure regulation via the bellows and plunger system, and pressure indication through the visual indicator. This multi-functionality resolves the contradiction by embedding pressure regulation capabilities within the existing connector structure rather than requiring additional separate components.

Inventive Principle:
Principle #6Universality (Multi-functionality)

2Adaptability or versatility

If pressure regulation features are added to needle-free connectors, then pressure control capability improves, but device complexity increases

Engineering Contradiction:
Improvepressure control capabilityVSAvoidconnector structure complexity
Core Design Contradiction:
Adaptability or versatilityVSDevice complexity

Solution Approach 1:

The patent employs dynamic elements including an elastomeric bellows that expands and contracts, a movable plunger that slides within the valve body, and a visual indicator that moves in response to pressure changes. These dynamic components enable adjustable pressure control by allowing the user to modify the bellows preload and observe real-time pressure status, providing adaptability while keeping the mechanism relatively simple through the use of flexible membranes and sliding parts rather than complex mechanical assemblies.

Inventive Principle:
Principle #15Dynamics

3Loss of information

If visual pressure indication is implemented, then real-time pressure monitoring capability improves, but manufacturing complexity increases

Engineering Contradiction:
Improvepressure information visibilityVSAvoidmanufacturing complexity
Core Design Contradiction:
Loss of informationVSEase of manufacture

Solution Approach 1:

The patent uses a visual indicator that changes its displayed information based on pressure conditions. The indicator mechanism, coupled to the bellows and plunger assembly, provides visual feedback (potentially through color changes or positional changes visible through a window) that reflects the current pressure state and whether the set pressure limit has been reached. This approach provides real-time pressure information monitoring while maintaining ease of manufacture by using optical indicators rather than complex electronic sensing and display systems.

Inventive Principle:
Principle #32Color 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

Ensures safe infusion by automatically regulating fluid pressure and providing real-time visual feedback to prevent excessive pressure, protecting patient health and equipment integrity.

Implementation Method 1

an indicator portion including a bellows

Methodology Applied
Scientific EffectElasticity: Elasticity

Implementation Method 2

a deformable valve

Methodology Applied
Scientific EffectPressure gradient: Pressure Gradient

Data Source

PatentUS20250375604A1Adjustable pressure regulating and pressure indicating needle-free connectors
Publication Date: 2025.12.11 CAREFUSION 303 INC
  • US20250375604A1 patent drawing
  • US20250375604A1 patent drawing
  • US20250375604A1 patent drawing

AI summary

A needle-free connector assembly is provided that includes a main housing coupled to an indicator housing. A plunger is coupled to a bellows disposed in the main housing. An inlet port is disposed at an upstream end of the indicator housing and an outlet port is disposed at a downstream end of the main housing, with a valve disposed within the indicator housing and adjacent the inlet port. A switch member is slidingly disposed in the main housing, wherein the needle-free connector assembly provides both flow regulation and pressure indication when the switch member is in a downstream position and only pressure indication when the switch member is in an upstream position. Infusion sets and methods of operating a needle-free connector are also provided.