Adjustable Needle-Free Connector for Pressure Regulation and 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
An adjustable needle-free connector with integrated pressure regulation and indication features, including a plunger, elastomeric bellows, and visual indicators, that automatically adjusts fluid flow based on set pressure thresholds.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If typical needle-free connectors are used, then the device complexity is low, but pressure regulation and indication capabilities are lacking
Solution Approach 1:
The patent combines pressure regulation and pressure indication functions into a single integrated connector assembly. The regulator body houses both the pressure regulating mechanism (adjustable needle-free connector with diaphragm) and the pressure indication system (color-coded indicators showing pressure ranges), allowing multiple functions to be performed by one device rather than separate components.
Solution Approach 2:
The connector assembly serves multiple functions: it regulates infusion pressure through adjustable restrictions, indicates pressure levels through color-coded visual feedback, and maintains fluid flow control. This multi-functional design eliminates the need for separate pressure monitoring and regulation devices, resolving the contradiction between enhanced reliability and device complexity.
2Object-affected harmful factors
If pressure regulation is added to prevent hemolysis and bag breakage, then patient safety is improved, but the device complexity increases
Solution Approach 1:
The connector incorporates a pressure indication system that provides real-time visual feedback to clinicians about the current infusion pressure. Color-coded indicators (green for safe range, yellow for approaching limit, red for excessive pressure) allow immediate recognition of pressure conditions, enabling timely adjustments to prevent hemolysis and bag breakage without complex monitoring equipment.
Solution Approach 2:
The pressure regulating mechanism allows adjustment of the pressure threshold through a dial or knob that modifies the restriction level in the fluid path. By changing the physical parameter of flow resistance, the system adapts to different infusion requirements while maintaining safety limits, preventing excessive pressure without requiring complex electronic control systems.
3Loss of information
If visual pressure indicators are integrated, then real-time pressure monitoring is improved, but the device complexity increases
Solution Approach 1:
The pressure indication system uses color-coded visual indicators that change appearance based on the current pressure level. Green indicators represent safe pressure ranges, yellow indicates approaching limits, and red signals excessive pressure. This color-based information transmission provides immediate, intuitive pressure feedback without requiring complex displays or electronics, minimizing device complexity while maximizing information delivery.
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
Provides real-time pressure indication and automatic shut-off to prevent excessive infusion pressures, ensuring safe and controlled fluid delivery.
Implementation Method 1
a bellows and a plunger coupled to the bellows
Implementation Method 2
a turbine coupled to the spring
Data Source
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.