Vascular Access Device Status Indicator for CRBSI Prevention

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Solution Overview

Problem

Current vascular access devices lack effective indicators to remind operators of the need for cleaning or replacement, leading to increased risks of catheter-related bloodstream infections (CRBSIs) due to contamination and biofilm formation, which are resistant to biocidal agents and can cause significant morbidity and mortality.

Innovation Solution

Integration of a status indicator on vascular access devices that communicates elapsed time, usage, and disinfection status, using various mechanisms such as time-sensitive adhesives, visual indicators, and chemical changes to alert operators when the device needs cleaning or replacement.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Productivity

If vascular access devices are used for extended periods without replacement, then productivity is improved by reducing the frequency of device changes, but reliability deteriorates due to increased risk of contamination and biofilm formation

Engineering Contradiction:
Improvefrequency of device changesVSAvoidrisk of contamination
Core Design Contradiction:
ProductivityVSReliability

Solution Approach 1:

The patent applies preliminary action by incorporating a status indicator that proactively signals contamination risk before actual infection occurs. The indicator uses time-sensitive adhesives or visual cues to alert operators in advance that the device requires replacement, enabling preventive action rather than reactive response to infection

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The patent implements feedback through a visual status indicator that continuously communicates the contamination risk level to operators. The indicator provides real-time information about device status (e.g., color changes, adhesive strength variations), creating a closed-loop system that guides replacement decisions based on actual device condition rather than fixed schedules

Inventive Principle:
Principle #23Feedback

2Reliability

If operators are reminded to clean or replace devices timely, then reliability is improved by reducing CRBSIs, but device complexity increases due to the addition of status indicators

Engineering Contradiction:
ImproveCRBSI preventionVSAvoidstatus indicator mechanism
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The patent applies self-service by designing status indicators that automatically track and report device status without external intervention. The time-sensitive adhesives and visual indicators autonomously monitor device condition and communicate status to operators, eliminating the need for complex external monitoring systems or manual tracking protocols

Inventive Principle:
Principle #25Self-service

Solution Approach 2:

The patent uses color changes as a simple, intuitive visual indicator mechanism to communicate device status. Different colors represent different contamination risk levels or time thresholds, providing clear, immediate information to operators without requiring complex displays, electronics, or training, thus minimizing the complexity increase

Inventive Principle:
Principle #32Color changes

3Loss of information

If status indicators are integrated into vascular access devices, then information availability is improved regarding device status, but manufacturing precision requirements increase

Engineering Contradiction:
Improvedevice status informationVSAvoidindicator integration
Core Design Contradiction:
Loss of informationVSManufacturing precision

Solution Approach 1:

The patent applies merging by integrating the status indicator functionality directly into the existing device structure rather than adding separate components. The time-sensitive adhesives and visual indicators are incorporated into the device housing or connector components, combining multiple functions (structural support, status indication, contamination detection) into unified elements that simplify manufacturing rather than complicate it

Inventive Principle:
Principle #5Merging (Combining)

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 status indicators significantly reduce the risk of CRBSIs by ensuring timely cleaning and replacement of vascular access devices, thereby minimizing contamination and biofilm formation, ultimately lowering morbidity and mortality associated with these infections.

Implementation Method 1

a movable member (26) initially held in place by a time-sensitive adhesive (24)

Methodology Applied
Scientific EffectTime-sensitive adhesive release:

Implementation Method 2

The movable member (26) is attached to the first end of a spring (28), and the second end of the spring (28) is attached to the body (12)

Methodology Applied
Scientific EffectSpring force: Spring

Implementation Method 3

The photochromic material (156) changes from a first color to a second color in response to exposure to ultraviolet (UV) light

Methodology Applied
Scientific EffectPhotochromism: Photochromism

Implementation Method 4

a thermochromic material that changes color in response to disinfection

Methodology Applied
Scientific EffectThermochromism: Thermochromism

Implementation Method 5

a pH sensor that detects changes in pH level in response to disinfection

Methodology Applied
Scientific EffectpH sensing:

Implementation Method 6

an alcohol sensor that changes color in response to exposure to alcohol

Methodology Applied
Scientific EffectAlcohol detection:

Data Source

PatentUS8163237B2Vascular access device pathogenic status indication
Publication Date: 2012.04.24 BECTON DICKINSON & CO
  • US8163237B2 patent drawing
  • US8163237B2 patent drawing
  • US8163237B2 patent drawing

AI summary

A vascular access device for communicating with the vascular system of a patient may include a status indicator. The status indicator may detect and signal that a pathogen is in communication with the vascular access device.