Physiological Sensor Refurbishment With Replaceable Sensing Assembly

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Solution Overview

Problem

The reprocessing of medical sensors often results in decreased reliability due to wear and damage of sensing components, and the current practice of replacing only the adhesive portions can lead to sensors being discarded unnecessarily, increasing costs.

Innovation Solution

A method for reprocessing physiological sensors that involves replacing the entire sensor assembly, including pre-testing and calibrating new components before refurbishment, to ensure reliability and cost-effectiveness, while retaining the sensor cable and patient monitor attachments.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Loss of substance

If only the adhesive portion of the sensor is replaced during reprocessing, then material costs are reduced, but the reliability of the sensor decreases due to wear and damage of sensing components

Engineering Contradiction:
Improvematerial costVSAvoidsensor reading reliability
Core Design Contradiction:
Loss of substanceVSReliability

Solution Approach 1:

The sensor is divided into replaceable sensing components and retained cable/connector portions. During reprocessing, only the sensing components are replaced while the cable and connector are retained if functional, creating a segmented replacement strategy that optimizes both cost and reliability

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The reprocessing approach changes from binary (replace entire sensor or only adhesive) to a graduated parameter-based approach where replacement extent is determined by functional testing results, component wear assessment, and damage evaluation, allowing optimal balance between cost and reliability

Inventive Principle:
Principle #35Parameter changes

2Reliability

If sensing components are replaced during reprocessing, then sensor reliability is improved, but material costs increase

Engineering Contradiction:
Improvesensor reading reliabilityVSAvoidmaterial cost
Core Design Contradiction:
ReliabilityVSLoss of substance

Solution Approach 1:

Sensing components are discarded after single use and recovered through replacement during reprocessing, while cable and connector portions are recovered and retained for future use if they pass functional testing, optimizing the balance between reliability improvement and material cost control

Inventive Principle:
Principle #34Discarding and recovering

Solution Approach 2:

Functional testing and component assessment are performed before final replacement decisions to preliminarily identify which components need replacement, preventing unnecessary replacements and optimizing material cost while ensuring reliability

Inventive Principle:
Principle #10Preliminary action

3Reliability

If strict functional testing procedures are instituted during reprocessing, then sensor reliability is improved, but the number of sensors eligible for refurbishment decreases

Engineering Contradiction:
Improvesensor performance reliabilityVSAvoidnumber of sensors eligible for refurbishment
Core Design Contradiction:
ReliabilityVSProductivity

Solution Approach 1:

Testing is segmented into critical functional checks rather than comprehensive testing of all parameters. Only components showing actual wear, damage, or functional degradation are identified for replacement, allowing more sensors to pass refurbishment eligibility criteria while maintaining reliability

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The testing protocol transitions from strict pass/fail criteria to a graduated assessment system that identifies specific components needing replacement based on actual condition, allowing sensors with minor wear to be refurbished successfully while still ensuring reliability through targeted component replacement

Inventive Principle:
Principle #35Parameter 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

This approach reduces material costs and extends the number of sensors eligible for refurbishment by ensuring reliable performance and cost savings over producing new sensors, while maintaining high fidelity readings.

Implementation Method 1

The detector is responsive to the emitted light after attenuation by pulsatile blood flowing in the tissue site

Methodology Applied
Scientific EffectLight attenuation: Absorption (EM radiation)

Data Source

PatentEP2544591B1Reprocessing of a physiological sensor
Publication Date: 2021.07.21 MASIMO CORP
  • EP2544591B1 patent drawingFigure 1A
  • EP2544591B1 patent drawingFigure 1B~1C
  • EP2544591B1 patent drawingFigure 2

AI summary

Because reprocessing or refurbishing of physiological sensors reuses large portions of an existing sensor, the material costs for refurbishing sensors is significantly lower than the material costs for making an entirely new sensor. Typically, existing reprocessors replace only the adhesive portion of an adhesive physiological sensor and reuse the sensing components. However, re-using the sensing components can reduce the reliability of the refurbished sensor and/or reduce the number of sensors eligible for refurbishing due to out- of-specification sensor components. It is therefore desirable to provide a process for refurbishing physiological sensors that replaces the sensing components of the sensor. While sensing components are replaced, generally, sensor cable and/or patient monitor attachments are retained, resulting in cost savings over producing new sensors.