Aseptic Tissue Fragmentation Device for Stem Cell Isolation

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Solution Overview

Problem

Current methods for isolating adipose-derived stem cells (ADSCs) and stromal vascular fraction from adipose tissue face regulatory challenges due to enzymatic digestion requirements and lack efficient processing devices for transforming tissue into a homogeneous fluid phase suitable for clinical use.

Innovation Solution

A device with interconnected chambers and rotary cutters, along with axial pistons, facilitates aseptic processing of biological tissues into a homogeneous fluid phase, enabling efficient isolation and concentration of stromal cells within a sealed, sterilizable system, allowing for direct syringe extraction and potential motorized operation.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Productivity

If enzymatic digestion is used to isolate ADSCs and SVF, then a large number of cells can be isolated rapidly, but it is classified as major manipulation subject to strict regulations

Engineering Contradiction:
Improvecell isolation speedVSAvoidregulatory compliance
Core Design Contradiction:
ProductivityVSReliability

Solution Approach 1:

The patent replaces the chemical/enzymatic digestion system with a mechanical fragmentation system. The device uses a rotary cutter with multiple blades that rotate at controlled speeds (50-2000 rpm) to mechanically fragment adipose tissue into micro-fragments, eliminating the need for enzymatic digestion while achieving rapid cell isolation and avoiding regulatory restrictions on major manipulation.

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

2Ease of operation

If tissue is processed into homogeneous fluid phase, then clinical usability is enhanced, but maintaining aseptic conditions throughout processing becomes more complex

Engineering Contradiction:
Improveclinical usabilityVSAvoidaseptic system complexity
Core Design Contradiction:
Ease of operationVSDevice complexity

Solution Approach 1:

The device is divided into two separate sealed chambers: a first chamber for loading and initial processing of adipose tissue, and a second chamber for final homogenization and product collection. This segmentation allows independent sterilization and maintenance of aseptic conditions in each chamber, simplifying the overall aseptic system while enabling continuous processing from raw tissue to homogeneous fluid product.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The patent introduces an intermediate sterile barrier system including a sterile filter membrane and sealed partition between the two chambers. This intermediary structure allows mechanical transmission of cutting forces while maintaining sterile separation, enabling the tissue to be processed in a controlled manner without direct exposure to non-sterile environments.

Inventive Principle:
Principle #24Intermediary (Mediator)

3Productivity

If multiple processing steps are combined in one device, then processing efficiency increases, but device structure becomes more complex

Engineering Contradiction:
Improveprocessing efficiencyVSAvoiddevice structure
Core Design Contradiction:
ProductivityVSDevice complexity

Solution Approach 1:

The patent merges three distinct processing functions into a single integrated device: (1) mechanical fragmentation via rotary cutter, (2) homogenization via pusher piston action, and (3) sterile filtration via filter membrane. These functions are combined in a unified two-chamber structure that processes adipose tissue continuously from raw material to homogeneous cell suspension, eliminating the need for multiple separate processing steps and equipment.

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 device effectively processes adipose tissue into a high-concentration stromal cell solution, addressing regulatory concerns and enhancing clinical usability by ensuring aseptic conditions and efficient sample preparation for laboratory or clinical applications.

Implementation Method 1

a cutter configured to rotate and create micro-fragmentations of the material to be processed

Methodology Applied
Scientific EffectMechanical cutting: Fracture Mechanics

Implementation Method 2

a pusher piston configured to move axially and transfer the material to be processed

Methodology Applied
Scientific EffectMechanical force: Mechanical Force

Implementation Method 3

transformed into a homogeneous fluid or semi-fluid phase intended for laboratory use or for clinical application

Methodology Applied
Scientific EffectMechanical homogenization:

Data Source

PatentEP4069819B1Device for the fragmentation of tissues within a sealed sterile environment with an aseptic procedure and method thereof
Publication Date: 2024.02.14 HYDRA SRL
  • EP4069819B1 patent drawingFigure 1
  • EP4069819B1 patent drawingFigure 2

AI summary

The invention relates to a device and the operating method therefor, for the fragmentation of a biological material within in a sealed sterile environment with an aseptic procedure.