Immunity Sensor for Hemolysis Detection in Whole Blood

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Solution Overview

Problem

Existing blood analyzers face interference issues when measuring blood gas and electrolyte parameters due to lysed blood cells, leading to inaccurate results, especially when plasma separation is not feasible and separate electrolyte concentration sensors are unavailable.

Innovation Solution

A method using an immittance sensor to measure electrical immittance at multiple frequencies, allowing for the calculation of hemolysis and hematocrit levels without separating plasma, and applying correction factors to affected analyte values, utilizing kernel-based orthogonal projections to latent structures for accurate measurements.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If optical methods are used to detect hemoglobin in serum, then lysed cells can be detected, but plasma separation is required which increases device complexity and time

Engineering Contradiction:
Improvelysed cell detection accuracyVSAvoidplasma separation requirement
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The patent extracts the hemoglobin detection function from the plasma separation process by using electrical immittance measurements on whole blood. The immittance sensor directly measures hemoglobin concentration in the blood sample without requiring physical separation of plasma from cells, thus eliminating the centrifuge or filtration steps while maintaining detection accuracy

Inventive Principle:
Principle #2Taking out (Extraction)

Solution Approach 2:

The patent replaces the mechanical plasma separation system (centrifuge or filter) with an electrical measurement system. By using electrical immittance at multiple frequencies, the system can distinguish hemoglobin signals from intact cells through mathematical modeling, substituting mechanical separation with electrical field-based detection

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

2Ease of operation

If electrical immittance is used to measure hematocrit, then measurement is simplified, but electrolyte concentration variations cause errors

Engineering Contradiction:
Improvehematocrit measurement simplicityVSAvoidhematocrit measurement accuracy
Core Design Contradiction:
Ease of operationVSMeasurement precision

Solution Approach 1:

The patent transitions from single-frequency immittance measurement to multi-frequency immittance measurement. By measuring at multiple frequencies and analyzing the frequency-dependent response, the system can separate the effects of electrolyte concentration from hematocrit, adding a frequency dimension to the measurement that enables simultaneous determination of both parameters

Inventive Principle:
Principle #17Another dimension (Dimensionality change)

Solution Approach 2:

The patent changes the measurement parameter from single-frequency conductance to multi-frequency immittance spectrum. By analyzing how immittance varies with frequency, the system can distinguish between effects caused by electrolyte concentration and those caused by hematocrit, allowing accurate hematocrit measurement without separate electrolyte compensation

Inventive Principle:
Principle #35Parameter changes

3Measurement precision

If plasma separation is performed to eliminate hemolysis interference, then measurement accuracy improves, but measurement time and device complexity increase

Engineering Contradiction:
Improveanalyte measurement accuracyVSAvoidplasma separation time
Core Design Contradiction:
Measurement precisionVSLoss of time

Solution Approach 1:

The patent extracts the hemolysis detection capability from the plasma separation process. By using electrical immittance measurements on whole blood, the system can detect and quantify hemolysis interference directly in the blood sample without requiring plasma separation, thus eliminating the time-consuming centrifugation or filtration steps

Inventive Principle:
Principle #2Taking out (Extraction)

Solution Approach 2:

The patent introduces mathematical modeling and correction algorithms as intermediaries between the raw immittance measurements and the final analyte results. These computational tools allow the system to account for hemolysis interference and electrolyte variations, providing accurate measurements without physical plasma separation

Inventive Principle:
Principle #24Intermediary (Mediator)

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 enables accurate measurement of hemolysis and hematocrit levels, correcting for interference in blood analyte values and reducing errors in patient diagnosis, even in point-of-care settings without separate plasma separation or electrolyte concentration sensors.

Implementation Method 1

employing an immittance sensor, measuring immittance at a plurality of frequencies, to obtain a value for the level of lysed blood in a sample

Methodology Applied
Scientific EffectElectrical immittance measurement: Electrical Impedance Tomography

Data Source

PatentEP3146332B1Hemolysis and hematocrit detection method and system
Publication Date: 2022.03.23 NOVA BIOMEDICAL CORP
  • EP3146332B1 patent drawingFigure 1~2
  • EP3146332B1 patent drawingFigure 3
  • EP3146332B1 patent drawingFigure 4

AI summary

A hemolysis detection method and system includes measuring a conductance of a blood sample in a sample test module at a plurality of multiple-frequency AC inputs provided by a sine-wave generator module, calculating an immittance value for each of the plurality of multiple-frequency AC inputs received from a multichannel A/D converter module using a computer processing module, and subjecting each immittance value calculated to a function that maps immittance values to either lysed blood levels or hematocrit levels residing in the processing module and applying further processing residing in a memory module to produce respective percent-lysed value or hematocrit value of the blood sample.