Disposable Cartridge for Simultaneous Hemoglobin and pH Analysis

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Solution Overview

Problem

Current point-of-care testing (POCT) systems for blood analysis, particularly CO-oximetry and blood gas measurements, face delays and inaccuracies due to sample transport and handling issues, leading to errors in measuring hemoglobin species and acid-base status, as they rely on incomplete measurements and assumptions that can result in incorrect patient oxygenation and acid-base status assessments.

Innovation Solution

A disposable cartridge system that combines spectroscopic and biosensor technologies for simultaneous measurement of hemoglobin species and blood pH, using a cartridge with an optical chamber, biosensor conduit, air bladder, and calibration fluid pouch, which allows for precise analysis of blood samples without the need for sample transfer, minimizing atmospheric contamination and ensuring accurate oxygenation and acid-base status assessment.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If blood samples are transported from collection site to central laboratory for testing, then comprehensive analysis can be performed, but delays occur and red blood cells continue to consume oxygen changing the chemical composition

Engineering Contradiction:
Improveaccuracy of blood gas and hemoglobin measurementsVSAvoidtime delay in testing
Core Design Contradiction:
Measurement precisionVSLoss of time

Solution Approach 1:

The system divides the blood analysis into two separate measurement paths: an optical chamber for spectroscopic measurement of hemoglobin species and a biosensor conduit for electrochemical measurement of blood gases and pH. This segmentation allows simultaneous measurement of different parameters without requiring sample transport to a centralized laboratory, thereby eliminating time delays while maintaining measurement accuracy.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The patent introduces a disposable cartridge as an intermediary device that contains both optical and biosensor measurement chambers. This cartridge serves as a portable analysis station that can be used at the point of care, eliminating the need for transporting blood samples to centralized laboratories while preserving sample integrity and measurement accuracy.

Inventive Principle:
Principle #24Intermediary (Mediator)

2Measurement precision

If CO-oximetry requires hemolyzing red blood cells using sound generator or chemical detergent, then blood sample becomes more transparent for spectroscopic measurement, but the measurement process becomes more complex and additional reagents are required

Engineering Contradiction:
Improvespectroscopic measurement accuracyVSAvoidcomplexity of hemolysis process
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The patent uses an optical chamber that creates a path for electromagnetic radiation to pass through the blood sample without requiring physical alteration of the red blood cells. By optimizing the optical path and using appropriate wavelengths, the system achieves spectroscopic measurements on intact blood samples, eliminating the need for hemolysis while maintaining measurement accuracy.

Inventive Principle:
Principle #26Copying

3Measurement precision

If spectroscopic techniques measure hemoglobin species in the wavelength range of 300nm to 2500nm, then hemoglobin measurement is accurate, but hydrogen ions and electrolytes cannot be measured by the same method

Engineering Contradiction:
Improvehemoglobin species measurement accuracyVSAvoidrange of measurable parameters
Core Design Contradiction:
Measurement precisionVSAdaptability or versatility

Solution Approach 1:

The patent combines two different measurement technologies within a single disposable cartridge: spectroscopic measurement in the optical chamber for hemoglobin species and electrochemical biosensor measurement in the biosensor conduit for blood gases and pH. This merging allows simultaneous measurement of multiple parameter types (hemoglobin, oxygen, carbon dioxide, pH, electrolytes) using a single integrated system, achieving both spectral accuracy and broad analytical versatility.

Inventive Principle:
Principle #5Merging (Combining)

4Ease of operation

If blood samples are exposed to air during transfer and handling, then oxygen from air is absorbed into the blood sample, but sO2 measurements become falsely elevated

Engineering Contradiction:
Improvesample handling convenienceVSAvoidoxygen saturation measurement accuracy
Core Design Contradiction:
Ease of operationVSMeasurement precision

Solution Approach 1:

The patent extracts the measurement process from the blood sample itself by using a disposable cartridge with sealed measurement chambers. The optical chamber and biosensor conduit are designed to measure blood parameters in situ without requiring the sample to be transferred or exposed to air, thereby eliminating atmospheric contamination while maintaining ease of operation through simple cartridge-based testing.

Inventive Principle:
Principle #2Taking out (Extraction)

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 system provides accurate and reliable measurements of hemoglobin species and blood pH, reducing errors associated with sample transport and handling, enabling confident monitoring of patient oxygenation and acid-base status, especially in neonates and emergency situations like smoke inhalation.

Implementation Method 1

CO-oximetry is a spectroscopic technique that is used to measure the different Hemoglobin (Hb) species present in a blood sample

Methodology Applied
Scientific EffectAbsorption Spectroscopy: Absorption Spectroscopy

Implementation Method 2

Parameters that can be measured in blood by spectroscopic techniques are limited by the amount of EMR absorbed by the analytes measured

Methodology Applied
Scientific EffectAbsorption (EM radiation): Absorption (EM radiation)

Implementation Method 3

blood gas and electrolyte measurements usually employ biosensors, also referred to as electrochemical sensors or electrochemical detectors

Methodology Applied
Scientific EffectElectrochemical sensing:

Implementation Method 4

an air bladder exit port, having an arrangement with the blood storage conduit entrance for providing pressurized air to the blood storage conduit via the blood storage conduit entrance, for urging the blood into the biosensor conduit

Methodology Applied
Scientific EffectPressure gradient: Pressure Gradient

Data Source

PatentEP3149489B1Joint spectroscopic and biosensor system for point-of-care testing
Publication Date: 2021.05.05 RELAY MEDICAL CORP
  • EP3149489B1 patent drawingFigure 1
  • EP3149489B1 patent drawingFigure 2A~2H
  • EP3149489B1 patent drawingFigure 3A~3F

AI summary

Some embodiments of the invention provide a system for measurement of at least two hemoglobin species in a patient's blood sample by spectroscopy, and measurement of at least pH of the blood sample by biosensor. The system comprises a disposable cartridge adapted for insertion into a slot of an analyzer, and the results are used to monitor the acid-base status of a patient. A method for monitoring the acid-base status of a patient using the system is also provided.