Microorganism Isolation Device Using Density Cushion

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Solution Overview

Problem

Current diagnostic methods for detecting pathogenic microorganisms in blood culture samples are time-consuming, often taking several days, and face challenges with interference from blood components, leading to inaccurate results and safety hazards during processing.

Innovation Solution

A separation device with a capillary tube, density cushion, and optical window is used to isolate and pellet microorganisms, allowing for safe and rapid characterization and identification by enabling efficient separation from blood culture broths and other complex samples, compatible with various interrogation techniques.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If traditional automated phenotypic ID tests are used with colonies grown from positive broth, then robust identification results are obtained, but the testing time is extended to 18-24 hours plus additional incubation time

Engineering Contradiction:
Improveidentification accuracyVSAvoiddiagnostic time
Core Design Contradiction:
ReliabilityVSLoss of time

Solution Approach 1:

The patent performs preliminary separation of microorganisms from blood culture broth before identification testing. The separation device isolates microorganisms in advance, allowing direct testing without requiring additional 18-24 hour incubation for colony growth, thus reducing total diagnostic time while maintaining identification accuracy

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The patent extracts microorganisms from the complex blood culture broth matrix using a separation device with density cushion and centrifugation. This extraction removes interfering blood components and media, enabling direct phenotypic or molecular identification testing without the time-consuming colony growth step while preserving microbial integrity for accurate identification

Inventive Principle:
Principle #2Taking out (Extraction)

2Loss of time

If microorganisms are isolated directly from positive blood culture bottles for faster testing, then diagnostic time is reduced to 3-8 hours, but the results are not robust for all microorganisms and lack manufacturer validation

Engineering Contradiction:
Improvediagnostic timeVSAvoididentification robustness
Core Design Contradiction:
Loss of timeVSReliability

Solution Approach 1:

The patent introduces a separation device as an intermediary step between blood culture broth and identification testing. This intermediary process selectively isolates microorganisms while removing blood products and media components that interfere with testing, creating a purified sample that is suitable for all types of microorganisms and compatible with manufacturer-validated test protocols

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The patent changes the physical state and composition of the sample by using density-based separation and centrifugation. This parameter change transforms the complex broth sample into a concentrated microbial pellet with removed interferents, enabling reliable testing across all microorganism types while maintaining the accelerated 3-8 hour diagnostic timeline

Inventive Principle:
Principle #35Parameter changes

3Quantity of substance

If two-step differential centrifugation and serum separator tube methods are used to recover microorganisms, then microorganisms can be isolated from blood culture broth, but the preparation contains contaminating blood components that cause poor results and the process is labor-intensive and unsafe

Engineering Contradiction:
Improvemicroorganism recoveryVSAvoidcontaminating blood components
Core Design Contradiction:
Quantity of substanceVSObject-generated harmful factors

Solution Approach 1:

The patent applies local quality by creating a density cushion with specific density properties (1.06-1.20 g/ml) that selectively separates microorganisms from blood components based on their different densities. This localized density-based separation ensures microorganisms are recovered while blood cells, platelets, and proteins remain in the supernatant, eliminating contamination without additional processing steps

Inventive Principle:
Principle #3Local quality

Solution Approach 2:

The patent extracts microorganisms from blood culture broth using a controlled centrifugation process with density cushion. This extraction selectively removes microorganisms while leaving behind contaminating blood components in the supernatant, which can then be discarded. The process is automated and contained, eliminating aerosol exposure risks while achieving clean microbial isolation

Inventive Principle:
Principle #2Taking out (Extraction)

4Productivity

If optical spectroscopy and mass spectrometry methods are used for rapid identification, then identification can be performed very quickly, but interference from fluorescent and absorptive compounds in culture media and blood samples reduces accuracy

Engineering Contradiction:
Improveidentification speedVSAvoidspectroscopic accuracy
Core Design Contradiction:
ProductivityVSMeasurement precision

Solution Approach 1:

The patent converts the harmful interference from blood components and culture media into a benefit by using density-based separation to remove these interferents before spectroscopic or mass spectrometric analysis. The same centrifugation process that isolates microorganisms also eliminates fluorescent and absorptive compounds that would otherwise interfere with optical detection, enabling rapid and accurate identification simultaneously

Inventive Principle:
Principle #22Blessing in disguise (Convert harm into benefit)

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 device provides a safe, efficient, and rapid means to isolate microorganisms, reducing processing time and improving diagnostic accuracy by minimizing interference from blood components, enabling identification within hours instead of days.

Implementation Method 1

The container has a density cushion, wherein the density cushion has a homogeneous density in the range of 1.025 to 1.120 g/ml

Methodology Applied
Scientific EffectDensity gradient centrifugation: Density Gradient

Implementation Method 2

a lower portion comprising a capillary tube having an internal diameter from about 0.001 to about 0.04 inches

Methodology Applied
Scientific EffectCentrifugal separation: Centrifugal Separation

Data Source

PatentEP2364218B1Container for the isolation and identification of microorganisms
Publication Date: 2020.04.15 BIOMERIEUX INC
  • EP2364218B1 patent drawingFigure 1~7
  • EP2364218B1 patent drawingFigure 8~11
  • EP2364218B1 patent drawingFigure 12

AI summary

The present invention is directed to a separation device or container that can be used in the separation, isolation or pelleting of microorganisms from a test samples known to contain or suspected of containing said microorganisms. Subsequently, the separated, isolated or pelleted microorganism sample can undergo one or more interrogation steps to provide measurements useful for the characterization and/or identification of microorganism. In one aspect of the present invention, the interrogation steps can occur in situ in the separation device or container described herein.