Back-Flushable Leukocyte Depletion Filter for Closed System Processing
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Solution Overview
Problem
Existing methods for leukocyte depletion from blood are labor-intensive, prone to cell contamination, and often require additional processing steps, such as centrifugation or chemical treatment, which can be stressful for the desired cells and may not maintain a closed system.
Innovation Solution
A biological fluid processing device with a porous fibrous leukocyte depletion filter and a diffusing plate, which allows for the efficient separation and recovery of leukocytes and stem cells while reducing contamination from red blood cells, maintaining a closed system and eliminating the need for extra-system rinse fluids.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Productivity
If traditional methods are used for leukocyte depletion, then leukocytes can be removed from blood, but the process is labor-intensive and requires additional processing steps like centrifugation
Solution Approach 1:
The patent combines leukocyte depletion and stem cell recovery into a single integrated filtration process using a specialized filter assembly. The filter simultaneously removes leukocytes while preserving and recovering stem cells in the retentate, eliminating the need for separate centrifugation steps and reducing overall process complexity
Solution Approach 2:
The filter assembly serves multiple functions: it acts as a leukocyte depletion filter, a stem cell recovery device, and a concentration system all in one unit. The same device performs what previously required multiple separate processing steps, improving productivity without adding complexity
2Reliability
If traditional leukocyte depletion methods are used, then leukocytes are removed, but cell contamination occurs and closed system integrity is compromised
Solution Approach 1:
The patent uses a membrane filter with controlled pore structure that acts as a selective barrier. The thin film membrane allows plasma and small molecules to pass while retaining cells, providing physical separation that prevents contamination and maintains closed system integrity throughout the process
Solution Approach 2:
The filter assembly incorporates different regions with specialized properties: a prefilter layer for large particle removal, a main membrane layer for cell separation, and a support structure for mechanical strength. Each layer has locally optimized properties that collectively achieve high purity recovery without contamination
3Manufacturing precision
If additional processing steps like centrifugation are used, then cell separation is achieved, but the cells are subjected to stress that may harm them
Solution Approach 1:
The patent replaces mechanical centrifugation with a filtration-based separation system. Instead of using centrifugal force that subjects cells to high g-forces and stress, the system uses passive filtration through a membrane with controlled pore size, achieving precise separation without mechanical stress on the cells
Solution Approach 2:
The membrane filter acts as an intermediary between the blood components. It provides a controlled interface that separates cells from plasma based on size exclusion, avoiding direct mechanical manipulation of the cells that would cause stress, while still achieving precise separation
4Adaptability or versatility
If open system processing is used, then additional processing flexibility is available, but sterile environment and closed system integrity are compromised
Solution Approach 1:
The patent employs a closed system design where all processing occurs within a sterile, controlled environment. The filter assembly is configured to maintain sterility throughout the process, allowing flexible processing options while protecting against contamination through integrated sterile barriers and sealed connections
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 reduces red blood cell contamination, simplifies the processing by avoiding additional steps like centrifugation, and ensures the recovery of desired cells in a sterile environment, maintaining the integrity of the closed system.
Implementation Method 1
a porous fibrous leukocyte depletion filter having an upstream surface and a downstream surface, disposed in the housing across the fluid flow path
Implementation Method 2
a perforated diffusing plate having a first surface and a second surface, disposed in the housing across the fluid flow path, wherein the diffusing plate is disposed in the housing between the downstream surface of the leukocyte depletion filter and the outlet
Implementation Method 3
passing gas through the outlet port and displacing biological fluid in the downstream chamber from the housing through the drain port into the second container or into a third container
Data Source
AI summary
Devices, methods, and systems for obtaining one or more biological fluid components, and reducing red blood cell contamination, using a back-flushable filter device, are disclosed.