Aseptic Biological Separation Device with Magnetic Membrane Actuation

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Solution Overview

Problem

Current methods for separating and concentrating biological components are prone to contamination due to exposure to pathogens and pose safety risks for users, as they often require needles or cap removal, and struggle with separating distinct liquid fractions without mixing them.

Innovation Solution

A sealed and sterile device with a plunger and self-sealing filter system that allows aseptic handling through a female luer-lock connection, eliminating the need for needles and ensuring safe, reliable operation, along with a buoy for separating fractions by density, preventing mixing during extraction.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If standard centrifuge tubes with caps are used for separation, then separation of biological components can be achieved, but contamination risk increases due to cap removal and exposure to pathogens

Engineering Contradiction:
Improveaseptic separationVSAvoidcontamination by pathogens
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent employs a flexible membrane at the bottom of the tube that can be deformed by a magnet to create openings for fraction extraction. This flexible film allows controlled access to separated fractions without requiring cap removal, maintaining aseptic conditions while enabling selective extraction of centrifuged layers

Inventive Principle:
Principle #30Flexible shells and thin films

Solution Approach 2:

The patent introduces a magnet as an intermediary tool that interacts with magnetic beads attached to the flexible membrane. The magnet remotely controls the membrane deformation and opening/closing of extraction ports without direct contact or penetration, eliminating needle-related contamination risks and user safety hazards

Inventive Principle:
Principle #24Intermediary (Mediator)

2Ease of operation

If needles are used to pierce caps for fraction extraction, then components can be removed from tubes, but user safety risks and contamination dangers increase

Engineering Contradiction:
Improvefraction extractionVSAvoidcontamination and user safety risks
Core Design Contradiction:
Ease of operationVSObject-affected harmful factors

Solution Approach 1:

The patent replaces needles with a magnet as an intermediary that remotely actuates the flexible membrane through magnetic forces. The magnet creates openings in the membrane by deforming it, allowing fraction extraction without physical penetration or cap removal, thereby eliminating needle-related safety risks and contamination pathways

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The patent substitutes the mechanical needle-piercing system with a magnetic field-based actuation system. The magnetic field deforms the flexible membrane to create controlled openings, replacing direct mechanical contact and penetration with a non-contact field-based mechanism that maintains sterility and user safety

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

3Reliability

If conventional tubes are used for centrifugation, then separation of components can be achieved, but difficulty arises in separately extracting subsequent liquid fractions without mixing them

Engineering Contradiction:
Improveseparation of biological componentsVSAvoidextraction of distinct fractions
Core Design Contradiction:
ReliabilityVSEase of operation

Solution Approach 1:

The patent divides the tube into multiple independent extraction zones along its length, each with its own magnet-actuated opening. This segmentation allows selective access to different centrifuged fractions at different heights without disturbing adjacent layers, enabling separate extraction of multiple fractions while maintaining their integrity and preventing mixing

Inventive Principle:
Principle #1Segmentation

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 ensures aseptic separation and concentration of biological components, preventing contamination and safely extracting distinct fractions without mixing, enhancing user safety and operational efficiency.

Implementation Method 1

a duct, fitted with a self-sealing filter, through which the automatic purge of the air/gas contained in the tube is made during the filling of the tube with the fluid to be separated and concentrated

Methodology Applied
Scientific EffectAutomatic purge:

Implementation Method 2

the self-sealing plunger filter, arranged in the automatic air/gas purge duct, comprises a gelling filling which, once the tube is filled with the fluid to be separated, is automatically moistened with the fluid and immediately gels and seals

Methodology Applied
Scientific EffectGelling: Gel

Implementation Method 3

separate and concentrate different liquids, tissues or body fluids aseptically in a sealed device using density gradients and/or differential centrifugation

Methodology Applied
Scientific EffectDensity gradients: Density Gradient

Implementation Method 4

separate and concentrate different liquids, tissues or body fluids aseptically in a sealed device using density gradients and/or differential centrifugation

Methodology Applied
Scientific EffectDifferential centrifugation: Centrifugal Separation

Data Source

PatentUS11071690B2Sealed sterile device for the aseptic separation and concentration of biological components
Publication Date: 2021.07.27 LAB FIDIA FARM S L U
  • US11071690B2 patent drawing
  • US11071690B2 patent drawing
  • US11071690B2 patent drawing

AI summary

A sealed sterile device for the aseptic separation and concentration of biological components, which includes: a tube sealed at first end and which has a mouth at second end; a plunger of flexible material, without an actuation rod, installed inside the tube with the possibility of longitudinal movement, and which has a hole for charging with a fluid to be separated and concentrated and discharging the separated fractions, the hole being provide with a valved female Luer lock connection, the plunger also having a purging duct provided with a self-sealing filter for the automatic purging of the air/gas contained in the tube during the filling of the tube with the fluid to be separated and concentrated; and a cap for protecting the connection-plunger assembly, couplable to the mouth of the tube.