Ultrasonic Instrument End-of-Life Indicator

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Solution Overview

Problem

Ultrasonic medical instruments are prone to fatigue and wear, leading to potential sudden failure and damage to organic tissues during surgical procedures, as existing methods lack effective indicators for monitoring instrument degradation.

Innovation Solution

An ultrasonic medical instrument with a biocompatible and biodegradable end-of-life indicator element made of ceramic or polymeric materials that gradually disintegrates with use, providing a visible indicator of the instrument's remaining useful life, which can be affixed to the probe shaft or head, and includes a secondary indicator that becomes visible once the primary indicator degrades.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Productivity

If ultrasonic instruments are used for extended periods to maximize productivity, then productivity improves, but reliability deteriorates due to fatigue and wear leading to sudden failure

Engineering Contradiction:
Improveinstrument usage durationVSAvoidinstrument failure risk
Core Design Contradiction:
ProductivityVSReliability

Solution Approach 1:

The patent applies preliminary action by incorporating an end-of-life indicator element that proactively signals instrument degradation before sudden failure occurs. The indicator element is pre-installed on the probe shaft and gradually disintegrates or changes appearance as the instrument accumulates use, providing advance warning to replace the instrument before it fails, thus maintaining both productivity and reliability.

Inventive Principle:
Principle #10Preliminary action

2Loss of substance

If instrument usage is extended beyond recommended limits to reduce costs, then cost efficiency improves, but harmful factors increase due to potential damage to organic tissues

Engineering Contradiction:
Improveinstrument replacement frequencyVSAvoidtissue damage risk
Core Design Contradiction:
Loss of substanceVSObject-affected harmful factors

Solution Approach 1:

The patent implements feedback through the end-of-life indicator element that provides continuous visual information about the instrument's degradation state. As the indicator element disintegrates or changes appearance with use, it gives real-time feedback to the operator about the instrument's remaining safe usage life, enabling timely replacement before tissue damage can occur, thus balancing cost efficiency with patient safety.

Inventive Principle:
Principle #23Feedback

3Device complexity

If no visual indicator is provided for instrument degradation, then device complexity is reduced, but measurement precision deteriorates as degradation cannot be detected

Engineering Contradiction:
Improveinstrument structureVSAvoiddegradation detection accuracy
Core Design Contradiction:
Device complexityVSMeasurement precision

Solution Approach 1:

The patent applies color changes by using an end-of-life indicator element that undergoes visible physical or chemical changes as it degrades. The indicator element may change color, become translucent, or disintegrate visibly, providing a simple yet effective visual measurement of the instrument's degradation state without adding complex monitoring systems, thus maintaining low device complexity while improving measurement precision.

Inventive Principle:
Principle #32Color changes

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 prevents sudden failure and reduces tissue damage by allowing medical personnel to monitor and retire the instrument before it reaches the end of its useful life, ensuring patient safety and preventing unnecessary damage.

Implementation Method 1

the indicator element being made of a second material that gradually disintegrates or degrades with use of the instrument

Methodology Applied
Scientific EffectDisintegration:

Implementation Method 2

source of ultrasonic mechanical vibratory energy

Methodology Applied
Scientific EffectUltrasonic vibration: Ultrasonic Vibration

Data Source

PatentEP3049001B1Ultrasonic instrument with use indicator
Publication Date: 2019.04.10 MISONIX INC
  • EP3049001B1 patent drawingFigure 1

AI summary

An ultrasonic medical instrument includes a probe shaft having a threaded coupling at a proximal end and an end effector or head at a distal end. The coupling is configured for operative attachment to a source of ultrasonic mechanical vibratory energy, while the head has an operative surface configured for engagement with organic tissues of a patient. The probe shaft, the coupling, and the head are made of a metal or metal alloy. At least one end-of-life indicator element is affixed to the probe shaft or head, the indicator element being made of a material that gradually disintegrates or degrades with use of the instrument so as to provide a visible indicator of degree of use and remaining useful life of the instrument.