Single-Procedure Indicators with Irreversible Sterilization Color Change

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Solution Overview

Problem

The reuse of single procedure medical devices poses a risk of transmitting nosocomial infections due to inadequate sterilization or misuse, necessitating a clear indication of end-of-use to prevent recirculation.

Innovation Solution

A biocompatible indicator region on single procedure devices transitions from an unmodified to a modified state upon exposure to sterilization, irreversibly identifying the device's discharge status through a composition of superabsorbent polymers, binders, and additives, ensuring visual and tactile recognition.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Productivity

If single procedure devices are reused, then productivity is improved, but reliability deteriorates due to risk of nosocomial infection transmission

Engineering Contradiction:

Improvedevice utilizationVSAvoidinfection risk

Core Design Contradiction:

ProductivityVSReliability

Solution Approach 1:

The indicator is applied to the device before use and undergoes irreversible changes during sterilization or use, providing advance warning before reuse becomes problematic. The color change occurs during the sterilization process itself, alerting personnel before the device is returned to circulation.

Inventive Principle:

Principle #10Preliminary action

Solution Approach 2:

The indicator provides visual feedback about the device's sterilization status and usage history. The color-changing mechanism creates a feedback loop where the device itself communicates its state to users, preventing misuse through immediate visual confirmation.

Inventive Principle:

Principle #23Feedback

2Reliability

If indicators are added to devices, then reliability is improved by preventing reuse, but device complexity increases

Engineering Contradiction:

Improvedischarge status identificationVSAvoidindicator system

Core Design Contradiction:

ReliabilityVSDevice complexity

Solution Approach 1:

The indicator utilizes color changes to communicate device status. Different colors indicate different states (e.g., sterile vs. used), providing clear visual distinction without requiring complex electronic or mechanical systems. The color change is irreversible, ensuring permanent status indication.

Inventive Principle:

Principle #32Color changes

Solution Approach 2:

The indicator employs composite material structures combining multiple functional components in a single integrated system. This includes the color-changing agent, binder, and protective layers working together as one unit, reducing overall system complexity while maintaining reliability.

Inventive Principle:

Principle #40Composite materials

3Reliability

If irreversible indicators are used, then reliability is improved by eliminating reuse possibility, but ease of operation deteriorates due to lack of reversibility for reprocessing

Engineering Contradiction:

Improveend-of-use identificationVSAvoidreprocessing flexibility

Core Design Contradiction:

ReliabilityVSEase of operation

Solution Approach 1:

The irreversible color change occurs during the initial sterilization process, establishing the device's status before it enters clinical use. This preliminary marking ensures that subsequent reprocessing attempts cannot reset the indicator, preventing reuse while maintaining operational simplicity.

Inventive Principle:

Principle #10Preliminary action

Solution Approach 2:

The indicator is designed as a single-use component that accompanies the disposable device through its lifecycle. The irreversible nature aligns with the disposable philosophy, where the indicator's permanent change confirms the device should not be reused, simplifying operational protocols.

Inventive Principle:

Principle #27Cheap short-living objects (Disposable)

4Measurement precision

If multiple indicator regions are implemented, then measurement precision is improved for status assessment, but device complexity increases

Engineering Contradiction:

Improvedischarge status detectionVSAvoidindicator regions

Core Design Contradiction:

Measurement precisionVSDevice complexity

Solution Approach 1:

Different regions of the indicator are designed with specific color-changing properties optimized for different sterilization methods or usage conditions. Each local region provides targeted information about specific aspects of the device's history, enhancing detection precision without requiring a completely new indicator system.

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 indicator effectively marks devices as end-of-use, reducing the risk of reuse and enhancing patient safety by providing a clear visual and tactile indication of sterilization exposure.

Implementation Method 1

the indicator is a biocompatible composition comprising at least one filler and one or more binders

Methodology Applied

Scientific EffectWater absorption: Absorption (physical)

Implementation Method 2

configured to transition from an unmodified state to a modified state in response to an exposure

Methodology Applied

Scientific EffectPhase transition: Phase Change

Data Source

PatentUS12434281B2Single procedure indicators

Publication Date: 2025.10.07 VIANT AS&O HLDG LLC

AI summary

Disclosed herein are single use indicators and methods for employing the same. Such indicators and their uses are directed towards identifying the discharge status of single procedure devices, which are typically, but not limited to, medical devices.