Auto-occlusion Valve for Infusion Systems

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Solution Overview

Problem

Rapid infusion procedures in vascular systems often lead to excessive fluid pressure, causing rupture of infusion components, which can result in adverse events such as device fragmentation, embolism, and patient injury, due to the inability of existing systems to effectively manage increased pressure.

Innovation Solution

An auto-occlusion safety device with a pressure-sensitive valve that automatically activates to occlude the fluid pathway when pressure exceeds a threshold, preventing rupture, and includes a locking mechanism to maintain occlusion and a visual indicator for activation status, along with an accumulator to divert and retain infusant and reduce pressure spikes.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If rapid infusion procedures are performed to enhance visualization and improve image quality, then bolus density and image quality are improved, but fluid pressure increases causing increased likelihood of infusion component rupture

Engineering Contradiction:
Improveimage qualityVSAvoidfluid pressure
Core Design Contradiction:
Measurement precisionVSObject-affected harmful factors

Solution Approach 1:

A pressure-sensitive occlusion valve is introduced as an intermediary device between the power injector and the infusion component. The valve automatically occludes the fluid pathway when fluid pressure exceeds a predetermined threshold, preventing excessive pressure from reaching the infusion component while still allowing rapid infusion procedures to be performed for enhanced image quality

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The occlusion valve is designed to automatically activate and deactivate based on fluid pressure conditions without requiring external control or user intervention. The valve self-regulates pressure by opening when pressure is within safe limits and automatically closing when pressure exceeds the threshold, providing self-service pressure protection during rapid infusion procedures

Inventive Principle:
Principle #25Self-service

2Measurement precision

If higher injection rates are used to produce enhanced bolus density, then image quality improves, but the likelihood of infusion component rupture increases due to increased pressure

Engineering Contradiction:
Improvebolus densityVSAvoidinfusion component integrity
Core Design Contradiction:
Measurement precisionVSReliability

Solution Approach 1:

The pressure-sensitive occlusion valve serves as a protective intermediary that monitors fluid pressure in real-time during high-rate infusion. When the injection rate produces pressure exceeding the safe threshold, the valve automatically occludes the pathway, preventing the excessive pressure from compromising the infusion component while allowing the high injection rate to continue for enhanced bolus density

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The occlusion valve is pre-configured with a predetermined pressure threshold that acts as a safety cushion before the infusion component reaches its rupture point. This beforehand protection mechanism allows the system to operate at higher injection rates for improved bolus density while the valve stands ready to activate if pressure approaches dangerous levels

Inventive Principle:
Principle #11Beforehand cushioning (Prior cushioning)

3Ease of operation

If line patency is compromised by patient or catheter position or flow rate induced kinking, then fluid delivery is obstructed, but pressure within the vascular access devices increases leading to increased rupture risk

Engineering Contradiction:
Improveline patencyVSAvoidpressure buildup
Core Design Contradiction:
Ease of operationVSObject-affected harmful factors

Solution Approach 1:

The pressure-sensitive occlusion valve acts as an intermediary pressure management device that distinguishes between beneficial pressure (from intentional rapid infusion) and harmful pressure (from accidental kinking or line obstruction). When pressure exceeds the threshold due to line patency issues, the valve automatically occludes upstream, preventing further pressure buildup that could cause rupture while allowing the line patency issue to be addressed

Inventive Principle:
Principle #24Intermediary (Mediator)

4Device complexity

If existing vascular access devices are used without pressure protection mechanisms, then device simplicity is maintained, but device rupture occurs under excessive pressure conditions

Engineering Contradiction:
Improvedevice simplicityVSAvoiddevice rupture resistance
Core Design Contradiction:
Device complexityVSReliability

Solution Approach 1:

A pressure-sensitive occlusion valve is introduced as a separate intermediary device rather than complicating the existing simple vascular access devices. This approach maintains the simplicity and ease of use of the original devices while adding pressure protection functionality through the standalone valve that automatically prevents excessive pressure from reaching the infusion component

Inventive Principle:
Principle #24Intermediary (Mediator)

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 auto-occlusion safety device effectively prevents component rupture by automatically regulating pressure, ensuring safer and more efficient rapid infusion procedures while providing a visual indication of activation and additional time for system shutdown through pressure management.

Implementation Method 1

A compression spring is interposedly positioned between the piston and the compression chamber, such that the portion of the piston disposed in the compression chamber is biased towards the lower portion of the compression chamber

Methodology Applied
Scientific EffectSpring: Spring

Data Source

PatentEP2282791B1Systems for providing an automatic occlusion device
Publication Date: 2019.10.16 BECTON DICKINSON & CO
  • EP2282791B1 patent drawingFigure 1
  • EP2282791B1 patent drawingFigure 1B
  • EP2282791B1 patent drawingFigure 2A

AI summary

An auto-occlusion safety device is provided for use in preventing rupture of infusion components during rapid infusion procedures. An occlusion valve is disclosed having a threshold pressure that is less than a rupture tolerance of the infusion system components. As the fluid pressure of the infusion system increases beyond the threshold pressure of the occlusion valve, the occlusion valve is automatically activated thereby occluding fluid flow upstream from a vulnerable infusion component. An accumulator is further disclosed for use in combination with the safety device to compensate for time delays in full activation of the occlusion valve.