Electroanalytical Bilirubin Measurement System

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Solution Overview

Problem

Current methods for diagnosing neonatal jaundice are inefficient and prone to errors due to pre-analytical issues, light degradation of bilirubin samples, and limitations in point-of-care testing, leading to delayed or incorrect diagnosis and increased risk of severe complications like kernicterus.

Innovation Solution

The development of electroanalytical systems and methods that use a release agent to measure bilirubin levels in a sample, allowing for simpler, faster, and more robust point-of-care testing by determining total serum bilirubin concentrations using electrochemical data, eliminating manual handling errors and providing extended shelf life.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If traditional laboratory methods are used for bilirubin measurement, then measurement precision may be maintained, but device complexity and manual handling increase leading to pre-analytical errors

Engineering Contradiction:
Improvebilirubin measurement precisionVSAvoidmanual handling complexity
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The patent replaces manual mechanical handling and traditional laboratory measurement systems with an automated optical detection system. The device automatically measures bilirubin levels through optical properties without requiring manual sample preparation, handling, or processing, thereby eliminating pre-analytical errors while maintaining measurement precision.

Inventive Principle:
Principle #28Mechanics substitution (Replace mechanical system)

Solution Approach 2:

The device enables self-service measurement where the system automatically performs all measurement functions without requiring manual intervention. The automated optical detection system handles sample analysis independently, eliminating the need for complex manual handling procedures while maintaining accurate bilirubin measurement.

Inventive Principle:
Principle #25Self-service

2Productivity

If point-of-care testing is implemented, then ease of operation and speed improve, but measurement precision and reliability may deteriorate due to sample degradation

Engineering Contradiction:
Improvetesting speedVSAvoiddiagnosis reliability
Core Design Contradiction:
ProductivityVSReliability

Solution Approach 1:

The device performs preliminary measurement action immediately upon sample acquisition at the point of care. By conducting the optical measurement right away without delays or complex preparation steps, the system prevents sample degradation while maintaining both speed and reliability of the diagnosis.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The patent replaces manual handling procedures with automated optical detection that is insensitive to sample degradation issues. The optical measurement method directly assesses bilirubin levels without requiring stable sample conditions, thereby maintaining reliability despite the rapid point-of-care testing format.

Inventive Principle:
Principle #28Mechanics substitution (Replace mechanical system)

3Ease of operation

If manual handling procedures are used, then measurement can be performed, but pre-analytical errors increase leading to delayed or incorrect diagnosis

Engineering Contradiction:
Improveoperational simplicityVSAvoidbilirubin level accuracy
Core Design Contradiction:
Ease of operationVSMeasurement precision

Solution Approach 1:

The patent replaces manual handling procedures with an automated optical detection system that eliminates pre-analytical errors. The device automatically performs measurements through optical properties of the sample, removing all manual steps that could introduce errors while maintaining operational simplicity for the user.

Inventive Principle:
Principle #28Mechanics substitution (Replace mechanical system)

Solution Approach 2:

The system performs self-service measurement where the device automatically handles sample analysis without manual intervention. This eliminates pre-analytical errors associated with manual handling while keeping the operation simple - the user only needs to initiate the measurement process.

Inventive Principle:
Principle #25Self-service

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

These systems enable accurate and rapid bilirubin measurement, reducing the risk of misdiagnosis and complications by providing reliable point-of-care testing, improving diagnostic accuracy and reducing the need for invasive laboratory procedures.

Implementation Method 1

measuring electrochemical data of the sample using an electrochemical cell; and determining a total serum bilirubin concentration of the sample using the electrochemical data

Methodology Applied
Scientific EffectElectrochemical detection:

Implementation Method 2

adding a release agent to the sample, the release agent configured to release the bound bilirubin from the albumin

Methodology Applied
Scientific EffectCompetitive binding displacement:

Data Source

PatentUS10371707B1System and methods for bilirubin analysis
Publication Date: 2019.08.06 NEOLIGHT LLC
  • US10371707B1 patent drawing
  • US10371707B1 patent drawing
  • US10371707B1 patent drawing

AI summary

A method for measuring bilirubin levels in a subject. The method can include the steps of providing a sample to be measured from the subject, wherein the sample comprises bilirubin bound to albumin; adding a release agent to the sample, the release agent configured to release the bound bilirubin from the albumin; measuring electrochemical data of the sample using an electrochemical cell; and determining a total serum bilirubin concentration of the sample using the electrochemical data. This method is capable of providing a simpler, faster, and more robust measurement when compared to traditional bilirubin assay methods.