Fusible and Reference Components for Medical Device Status Detection

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Solution Overview

Problem

Existing methods for preventing the reuse of medical device components, such as disposable instruments in invasive surgeries, face challenges due to complex software validation requirements and the inability to reliably indicate the status and integrity of these components, potentially leading to cross-contamination or improper reuse.

Innovation Solution

A method and apparatus utilizing a combination of fusible and non-fusible components to determine the status of medical device components, including whether they have been used, their identity, and type, by measuring properties like resistance or capacitance, ensuring that the components cannot be reused inappropriately and tailoring the operation of the main medical device accordingly.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If complex electronic reuse mitigation measures such as RFID chips or integrated circuits containing software are used, then the ability to identify and track medical device component status is improved, but device complexity and software validation requirements increase

Engineering Contradiction:
Improvestatus identification accuracyVSAvoidelectronic component complexity
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The patent extracts the identification function from complex electronic systems (RFID, software) and implements it through simple passive electronic components (fusible and non-fusible elements) that can be read by the controlling system without requiring active communication or power sources.

Inventive Principle:
Principle #2Taking out (Extraction)

Solution Approach 2:

The patent uses inexpensive passive electronic components instead of expensive reusable electronic identification systems. The fusible and non-fusible elements are simple, low-cost components that provide reliable status indication without the complexity of programmable or communicative electronic systems.

Inventive Principle:
Principle #27Cheap short-living objects (Disposable)

2Device complexity

If a onetime fusible element is used to indicate use status, then the indication of used status is simple and reliable, but the ability to identify the device and verify connection integrity is lost

Engineering Contradiction:
Improvestatus indication simplicityVSAvoiddevice identification capability
Core Design Contradiction:
Device complexityVSMeasurement precision

Solution Approach 1:

The patent combines multiple functions into a single integrated system: the fusible element indicates use status, the non-fusible element provides device identification and connection verification, and together they enable comprehensive status monitoring without requiring separate systems for each function.

Inventive Principle:
Principle #5Merging (Combining)

3Reliability

If disposable medical device components are discarded after single use, then prevention of reuse and cross-contamination is achieved, but cost efficiency and revenue optimization are reduced

Engineering Contradiction:
Improveprevention of cross-contaminationVSAvoidcost efficiency
Core Design Contradiction:
ReliabilityVSProductivity

Solution Approach 1:

The patent implements a feedback mechanism where the controlling system reads the status of fusible and non-fusible elements to determine component usage state, enabling automated prevention of reuse while providing clear status information for inventory management and cost tracking.

Inventive Principle:
Principle #23Feedback

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

This solution provides a simple, robust, and reliable way to prevent the reuse of medical device components, ensuring safety and maintaining the integrity of medical devices by using dual-state circuits that indicate used/unused and connected/disconnected states, thereby preventing cross-contamination and ensuring tailored operation based on the specific device type.

Implementation Method 1

at least one fusible component to indicate whether the medical device component has been used

Methodology Applied
Scientific EffectFusible: Melting

Implementation Method 2

by measuring properties like resistance or capacitance

Methodology Applied
Scientific EffectElectrical Resistance: Electrical Resistance

Implementation Method 3

by measuring properties like resistance or capacitance

Methodology Applied
Scientific EffectCapacitance: Capacitance

Data Source

PatentEP2844179B1Apparatus and method for determinging a status of a medical device component
Publication Date: 2019.12.04 EMBLATION
  • EP2844179B1 patent drawingFigure 1
  • EP2844179B1 patent drawingFigure 2(a)~2(b)
  • EP2844179B1 patent drawingFigure 3~4

AI summary

Apparatus for determining a status of a medical device component, wherein the apparatus comprises at least one fusible component to indicate whether the medical device component has been used, and at least one reference component having at least one reference property that is representative of the presence, identity or type of the medical device component, wherein the reference component is non-fusible under ordinary operating conditions.