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
Engineering 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
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.
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
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.
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.
3Productivity
If multiple processing steps are combined in one device, then processing efficiency increases, but device structure becomes more complex
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.
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
Implementation Method 2
a pusher piston configured to move axially and transfer the material to be processed
Implementation Method 3
transformed into a homogeneous fluid or semi-fluid phase intended for laboratory use or for clinical application
Data Source
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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.