Disposable Centrifuge Insert for Stem Cell Separation
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Solution Overview
Problem
Current devices for isolating stromal or stem cells from medullary aspirate are costly, complex, and difficult to use, lacking in precision and convenience for operators.
Innovation Solution
A modular, disposable medical device with a centrifugation system and automated apparatus for precise separation of blood fractions, allowing for the isolation of stromal or stem cells in a closed system, preventing contamination and enabling easy handling and disposal.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Manufacturing precision
If a rigid insert with density-based separation is used in a centrifugable container, then separation of blood fractions is achieved, but device complexity and manufacturing cost increase
Solution Approach 1:
The patent employs a disposable centrifugable container with an integrated rigid insert designed for single-use. This eliminates the need for complex cleaning and sterilization procedures, reduces device complexity for reuse, and ensures consistent separation precision without requiring multiple reusable components. The disposable nature allows for pre-sterilization and quality control during manufacturing while simplifying the overall device architecture.
2Adaptability or versatility
If a cannula system with multiple hollow elements is used for selective sampling, then fraction sampling capability is improved, but ease of operation deteriorates
Solution Approach 1:
The patent extracts the sampling function from the complex multi-element cannula system and implements it through a simpler alternative opening system. The rigid insert includes predefined openings at specific heights that align with collection tubes during centrifugation, allowing selective sampling of different blood fractions without requiring complex cannula manipulation. This maintains fraction sampling capability while dramatically improving ease of operation.
Solution Approach 2:
The rigid insert is pre-configured with openings at predetermined heights during manufacturing, positioned to align with specific collection tubes based on blood fraction density. This preliminary arrangement eliminates the need for complex real-time manipulation of cannula elements during operation, as the alignment is automatically achieved through the centrifugation process and pre-set geometric relationships.
3Measurement precision
If a valve device with multiple positions is used for fluid communication control, then sampling precision is improved, but device complexity increases
Solution Approach 1:
The patent removes the valve device entirely from the system and replaces it with a passive opening system in the rigid insert. The openings are positioned at fixed heights and automatically align with collection tubes during centrifugation based on blood fraction separation, achieving sampling precision without requiring active valve control mechanisms. This extraction of the valve function simplifies the device architecture while maintaining precise fraction collection.
4Reliability
If a closed system is used for cell isolation, then contamination prevention is improved, but device complexity increases
Solution Approach 1:
The patent merges multiple functions into the centrifugable container with an integrated rigid insert: separation, containment, and collection all occur within a single closed system. The rigid insert with predefined openings serves both as a separation element and a collection interface, eliminating the need for separate transfer steps that could compromise sterility. This integration maintains contamination prevention while reducing overall device complexity compared to systems requiring multiple separate components.
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 cost-effective, precise, and safe method for isolating stromal or stem cells, facilitating automated and convenient separation of blood fractions, enhancing the efficiency of cell therapy applications.
Implementation Method 1
separating it into fractions, and obtaining a concentrate of cells from one of the separated fractions
Implementation Method 2
the portion with intermediate density, i.e., the buffy coat, in a central funnel-shaped area of the insert itself
Data Source
AI summary
A medical device for the separation of a concentrate enriched with cells from a biological fluid, in particular a concentrate of stromal or stem cells from medullar aspirate or venous blood, comprises:a treatment container for receiving and treating the biological fluid for the purposes of its separation into a number of fractions;a first collection container, for receiving a first fraction of the fluid, in particular a fraction poor in said cells;a second collection container, for receiving a second concentrated fraction of the fluid enriched with said cells;a deviator valve having a first way connected or prearranged for connection to the treatment container, a second way connected or prearranged for connection to the first collection container, and a third way connected or prearranged for connection to the second collection container;a first line for connection of the treatment container to the first way of the deviator valve, a second line for connection of the first collection container to the second way of the deviator valve, and a third line for connection of the second collection container with the third way of the deviator valve.The treatment container is a syringe container with a plunger having a plunger stem associated in a releasable way to a corresponding plunger head, and the first connection line comprises a first transparent tube, in particular a flexible transparent tube, and at least one of the second and third connection lines preferably comprises a second flexible tube. At least one connection line, or each connection line, further comprises:at least one respective hydraulic connector, for separable connection of a corresponding tube to the corresponding container and/or to the corresponding way of the deviator valve; andat least one automatic-closing or one-way valve.