Mechanical Blood Separator Float Bellows Ballast

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Solution Overview

Problem

Conventional blood sample separation devices using thixotropic gels or mechanical separators face issues such as limited shelf-life, chemical reactions with analytes, premature release of fluid phases, and complex manufacturing processes, leading to sample contamination and poor sample quality.

Innovation Solution

A mechanical separator assembly within a tube that moves under centrifugal force, comprising a float, ballast, and bellows, with a pierceable head and isolated seal function, optimized for density between fluid phases to separate serum and plasma without interfering with analytes and using simpler manufacturing techniques.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If thixotropic gel materials are used as separation barriers, then separation between heavier and lighter phases is achieved, but shelf-life is limited and globules may be released causing clogging

Engineering Contradiction:
Improveseparation barrier stabilityVSAvoidshelf-life
Core Design Contradiction:
ReliabilityVSDuration of action of stationary object

Solution Approach 1:

The patent replaces the thixotropic gel material system with a mechanical separator system consisting of a float, bellows, and ballast. This mechanical system provides separation barrier functionality without the chemical and physical degradation issues of gel materials, thereby extending shelf-life and maintaining reliability.

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

Solution Approach 2:

The patent changes the fundamental parameter of the separation barrier from a chemical gel material to a mechanical device with controllable density (through ballast adjustment). This allows the separator to maintain its position and function over extended periods without the globule release and degradation problems associated with gel materials.

Inventive Principle:
Principle #35Parameter changes

2Reliability

If gel barriers are used for separation, then phase separation is maintained, but chemical reactions with analytes may occur causing adverse reactions

Engineering Contradiction:
Improveseparation maintenanceVSAvoidchemical reaction with analytes
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent replaces the chemical gel barrier with a mechanical separator that uses density-based positioning (float-bellows-ballast system) rather than chemical interaction. This eliminates chemical reactions with analytes while maintaining effective phase separation through physical barrier formation.

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

Solution Approach 2:

The mechanical separator acts as an intermediary device that physically separates phases without chemically interacting with the analytes. The separator's materials are selected to be chemically inert, mediating the separation process without introducing adverse chemical reactions.

Inventive Principle:
Principle #24Intermediary (Mediator)

3Stability of the object's composition

If conventional mechanical separators are affixed to tube closure, then premature movement is prevented, but sample pooling and pre-launch may occur

Engineering Contradiction:
Improveseparator position stabilityVSAvoidsample quality
Core Design Contradiction:
Stability of the object's compositionVSReliability

Solution Approach 1:

The patent employs a dynamic float-bellows-ballast system that automatically adjusts its position based on the density of the fluid sample and applied centrifugal force. This dynamic positioning eliminates the need for fixed attachment to tube closure, preventing sample pooling and pre-launch while maintaining stability during centrifugation.

Inventive Principle:
Principle #15Dynamics

Solution Approach 2:

The separator's effective density is可调 (adjustable) through the ballast component, allowing it to optimize its position within the tube based on sample characteristics and centrifugal force. This parameter adjustment capability ensures reliable separation without premature movement or sample pooling.

Inventive Principle:
Principle #35Parameter changes

4Reliability

If conventional mechanical separators with bellows are used, then sealing is provided, but manufacturing complexity increases due to multi-part fabrication

Engineering Contradiction:
Improvesealing functionVSAvoidmanufacturing complexity
Core Design Contradiction:
ReliabilityVSEase of manufacture

Solution Approach 1:

The patent combines multiple functions (sealing, positioning, and separation) into an integrated float-bellows-ballast assembly. The bellows component serves both as a sealing element and as part of the density-adjustment mechanism, reducing the number of separate parts and simplifying manufacturing while maintaining reliable sealing.

Inventive Principle:
Principle #5Merging (Combining)

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 mechanical separator effectively separates blood components without cross-contamination, is stable for radiation sterilization, and reduces manufacturing complexity, ensuring better sample quality and compatibility with standard sampling equipment.

Implementation Method 1

the device and fluid sample are subjected to centrifugation in order to cause separation of the heavier fraction from the lighter fraction of the fluid sample

Methodology Applied
Scientific EffectCentrifugal force: Centrifugal Force

Implementation Method 2

The components of the separator are dimensioned and configured to achieve an overall density for the separator that lies between the densities of the phases of a fluid sample

Methodology Applied
Scientific EffectDensity gradient: Density Gradient

Data Source

PatentEP2527039B1Density phase separation device
Publication Date: 2015.06.24 BECTON DICKINSON & CO
  • EP2527039B1 patent drawingFigure 1
  • EP2527039B1 patent drawingFigure 2
  • EP2527039B1 patent drawingFigure 3~4

AI summary

A mechanical separator for separating a fluid sample into first and second phases is disclosed. The mechanical separator includes a float having a passageway extending between first and second ends thereof with a pierceable head enclosing the first end of the float, a ballast longitudinally moveable with respect to the float, and a bellows extending between a portion of the float and a portion of the ballast. The bellows is adapted for deformation upon longitudinal movement of the float and the ballast, with the bellows isolated from the pierceable head. The float has a first density and the ballast has a second density greater than the first density. The bellows is structured for sealing engagement with a cylindrical wall of a tube, and the pierceable head is structured for application of a puncture tip therethrough. The separation device is suitable for use with a standard medical collection tube.