Flexible Compartment Cell Separation Device for High-Yield Stem Cell Recovery

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Solution Overview

Problem

Current methods for concentrating stem cells from umbilical cord blood and bone marrow aspirate result in low yields and require large volumes, making it difficult to achieve highly concentrated buffy coat fractions necessary for clinical applications.

Innovation Solution

The development of an apparatus and method using a flexible compartment supported by a rigid exoskeleton, allowing for the separation and concentration of stem cells, platelet poor plasma, and red blood cell fractions under sterile conditions, with the ability to automate the process and recover fractions in a smaller volume than traditional methods.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Quantity of substance

If traditional blood banking equipment or small volume platelet concentration systems are used to concentrate stem cells, then the procedure can be performed, but the recovery yield is low and large volumes are required

Engineering Contradiction:
Improvestem cell recovery yieldVSAvoidvolume of buffy coat fraction
Core Design Contradiction:
Quantity of substanceVSVolume of moving object

Solution Approach 1:

The device divides the blood sample into distinct density-based fractions (plasma, buffy coat, red blood cells) using multiple density shelves, allowing selective recovery of the buffy coat fraction containing stem cells. This segmentation enables high recovery yield in a small volume by isolating stem cells from the bulk plasma and red blood cells.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The device utilizes density as a separating parameter, with adjustable density shelves that create specific density zones. By changing the density parameters of the separation medium, the system can optimize the concentration and recovery of stem cells in the buffy coat fraction while minimizing the overall volume required.

Inventive Principle:
Principle #35Parameter changes

2Manufacturing precision

If density shelves are used for separating blood components, then separation is achieved, but the device complexity increases

Engineering Contradiction:
Improveseparation precision of blood fractionsVSAvoidcomplexity of separation system
Core Design Contradiction:
Manufacturing precisionVSDevice complexity

Solution Approach 1:

The density shelf system is designed to perform multiple separation functions simultaneously, separating plasma, buffy coat, and red blood cells in a single operation. This multi-functionality achieves high separation precision while controlling device complexity by consolidating multiple separation steps into one integrated system.

Inventive Principle:
Principle #6Universality (Multi-functionality)

Solution Approach 2:

The device incorporates pre-formed density shelves with predetermined density values, eliminating the need for complex real-time density adjustments during operation. This preliminary preparation of separation parameters simplifies the operational complexity while maintaining high separation precision for different blood fractions.

Inventive Principle:
Principle #10Preliminary action

3Productivity

If manual separation methods are used, then the process can be performed, but automation capability is limited

Engineering Contradiction:
Improveprocessing efficiencyVSAvoidautomation of separation process
Core Design Contradiction:
ProductivityVSExtent of automation

Solution Approach 1:

The device is designed with automated mechanisms that enable the system to perform separation and fraction collection without extensive manual intervention. The automated density shelf system and fraction collection mechanisms improve processing efficiency while increasing the extent of automation, allowing the system to self-regulate and self-collect fractions.

Inventive Principle:
Principle #25Self-service

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

Enables the recovery of highly concentrated buffy coat fractions with greater than 95% recovery in a small volume, along with other fractions like platelet poor plasma and red blood cells, reducing contamination risks and improving point-of-care therapies.

Implementation Method 1

separating the plurality of cells into distinct relative density layers

Methodology Applied
Scientific EffectSedimentation: Sedimentation

Data Source

PatentUS8241592B2Cell separation method and apparatus
Publication Date: 2012.08.14 CERVOS MEDICAL LLC
  • US8241592B2 patent drawing
  • US8241592B2 patent drawing
  • US8241592B2 patent drawing

AI summary

Disclosed herein are apparatus and methods for isolating a fraction of interest from a physiological fluid sample. A sample holder for isolating a fraction of interest from a physiological fluid sample includes a flexible compartment and a rigid exoskeleton that supports the flexible compartment. The flexible compartment may have at least one reservoir with a height to volume ratio of about 0.1 cm/mL to about 5 cm/mL. An automated device for extracting a fraction of interest from the sample includes a sample holder with a flexible compartment supported by a rigid exoskeleton, a support for the sample holder connected to one or more fluid extraction devices, and a motor for moving the extraction device relative to the sample holder. The automated device may include an optical sensor and may include a clamp for clamping the flexible compartment.