Vascular Access Device Volume Displacement Control

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Solution Overview

Problem

Current vascular access devices face complications such as catheter-related bloodstream infections (CRBSIs) due to reflux or displacement of blood from the vascular system into the extravascular system, leading to biofilm formation and potential embolisms, which existing sealed systems fail to adequately prevent.

Innovation Solution

A medical device with a vascular access port featuring a septum and a pivoting member, such as a T-bone or L-shaped rigid structure, that controls volume displacement within the extravascular system by inserting a substance to offset volume changes, preventing blood reflux through the use of a bistable spring or tension-based mechanisms.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Object-affected harmful factors

If a sealed system of extravascular devices is used to prevent external contamination, then protection against external bacteria is improved, but blood reflux into the extravascular system occurs due to volume changes and pressure differentials

Engineering Contradiction:
Improveexternal bacterial contaminationVSAvoidblood reflux into extravascular system
Core Design Contradiction:
Object-affected harmful factorsVSObject-generated harmful factors

Solution Approach 1:

The patent applies preliminary anti-action by incorporating a blood reflux prevention mechanism that actively counteracts the vacuum pressure generated during device removal. The system includes a check valve or one-way valve arrangement that prevents blood from flowing backward into the extravascular system when volume increases occur during device disconnection, thereby preemptively blocking the harmful effect before it can occur.

Inventive Principle:
Principle #9Preliminary anti-action

Solution Approach 2:

The patent uses an intermediary mechanism in the form of a valve or flow control element positioned between the vascular system and the extravascular system. This intermediary allows normal infusion flow while blocking reverse blood flow during volume displacement events, effectively mediating between the sealed system requirements and the prevention of blood reflux.

Inventive Principle:
Principle #24Intermediary (Mediator)

2Ease of operation

If devices are removed from the extravascular system, then access for infusion is improved, but the volume of the extravascular system increases causing vacuum pressure that draws blood into the system

Engineering Contradiction:
Improvedevice access and removalVSAvoidprevention of blood entry into extravascular system
Core Design Contradiction:
Ease of operationVSReliability

Solution Approach 1:

The system incorporates a reflux prevention valve that is pre-configured to automatically activate when volume displacement occurs during device removal. This preliminary anti-action mechanism counteracts the vacuum pressure effect before it can draw blood into the system, allowing easy device access while maintaining reliability.

Inventive Principle:
Principle #9Preliminary anti-action

Solution Approach 2:

The patent implements a self-regulating volume compensation mechanism that automatically detects and corrects volume changes in the extravascular system. When devices are removed and volume increases, the system self-adjusts by controlling fluid flow or activating compensation mechanisms to maintain pressure equilibrium, preventing blood reflux without requiring external intervention.

Inventive Principle:
Principle #25Self-service

3Adaptability or versatility

If the volume of the extravascular system is increased during device removal, then device exchange is facilitated, but vacuum pressure decreases causing blood to flow from the vascular system to the extravascular system

Engineering Contradiction:
Improvedevice exchange capabilityVSAvoidblood flow into extravascular system
Core Design Contradiction:
Adaptability or versatilityVSObject-generated harmful factors

Solution Approach 1:

A flow control valve serves as an intermediary element that permits forward fluid flow during device exchange while blocking reverse blood flow. This mediator allows the system to adapt to device removal and volume changes while preventing the harmful effect of blood entering the extravascular system.

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The patent applies local quality by implementing a one-way flow control mechanism at the critical interface where blood reflux occurs. The valve or check mechanism is positioned specifically at the point where volume displacement could cause harmful backflow, providing localized protection while maintaining overall system versatility for device exchange.

Inventive Principle:
Principle #3Local quality

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 solution effectively limits or prevents blood reflux into the extravascular system, reducing the risk of biofilm formation and embolisms, thereby enhancing the safety and reliability of infusion therapy by maintaining a stable fluid dynamics within the vascular system.

Implementation Method 1

A pivoting member in communication with the access port pivots when the port is accessed by an access device. The pivoting member may articulate upon a bistable spring, a torsion spring, or other spring or tension creating member.

Methodology Applied
Scientific EffectElasticity: Elasticity

Implementation Method 2

The pivoting member may articulate upon a bistable spring, a torsion spring, or other spring or tension creating member.

Methodology Applied
Scientific EffectTorsion spring: Torsion Spring

Data Source

PatentEP2046418B1Vascular access device volume displacement
Publication Date: 2013.01.16 BECTON DICKINSON & CO
  • EP2046418B1 patent drawingFigure 1
  • EP2046418B1 patent drawingFigure 2
  • EP2046418B1 patent drawingFigure 3

AI summary

A medical device includes a vascular access device with an access port having a septum and a slit. The slit is formed on the inner surface of the body of the septum where the access port receives an access device that is separate from the vascular access device through the slit of the septum. A pivoting member in communication with the access port pivots when the port is accessed by an access device. The medical device may be used to control the volume displacement of a chamber within the medical device by decreasing the volume of the chamber by inserting a substance having a mass into the chamber, pivoting a structure associated with the chamber, and increasing the volume of the chamber simultaneously and commensurately with the mass of the substance inserted into the chamber.