Closed-Loop Blood Processing for Concurrent Leukapheresis and Enrichment
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Solution Overview
Problem
Current leukapheresis processes are inefficient, time-consuming, and costly, with risks of microbial contamination, loss of valuable lymphocytes and platelets, and complications such as thrombocytopenia, due to the use of separate devices for collection, enrichment, and modification of blood components in a patient-disconnected manner.
Innovation Solution
A closed-loop, patient-connected device for concurrent leukapheresis and enrichment of target cells, allowing simultaneous collection of bulk mononuclear cells, enrichment of specific target cells, and return of non-target cells to the patient, with optional modification of target cells before reinfusion.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If separate devices are used for leukapheresis, enrichment, and modification in a patient-disconnected manner, then each function can be performed with specialized equipment, but the process becomes time-consuming, costly, and risks microbial contamination and loss of valuable cells
Solution Approach 1:
The patent combines leukapheresis collection, cell enrichment, and cell modification functions into a single integrated device that maintains patient connection throughout the process. This eliminates the need to disconnect and transfer cells between separate devices, thereby reducing microbial contamination risk and processing time while maintaining specialized functionality for each operation.
Solution Approach 2:
The system enables continuous patient connection and continuous cell flow through the integrated device, eliminating interruptions and disconnections that occur with separate devices. The continuous operation maintains cell viability, reduces exposure to contamination, and accelerates the overall process by eliminating idle transfer times.
2Ease of manufacture
If separate devices are used for collection, enrichment, and modification, then each device can be optimized for its specific function, but operating costs increase and valuable lymphocytes and platelets are lost
Solution Approach 1:
The integrated device incorporates specialized subsystems for leukapheresis collection, magnetic-activated cell sorting enrichment, and modular cell modification within a single platform. This merging approach maintains the functional optimization of each subsystem while eliminating cell loss associated with transfer between separate devices and reducing overall operating costs through shared infrastructure.
Solution Approach 2:
The device provides multi-functionality by integrating collection, enrichment, and modification capabilities in one system. The universal platform can handle various cell types and modification protocols while maintaining specialized functionality, thereby reducing cell loss and operational costs compared to multiple separate specialized devices.
3Reliability
If multiple separate devices are used for blood processing, then each device can perform its specific task effectively, but the complexity of the overall system increases and efficiency decreases
Solution Approach 1:
The patent integrates multiple functional subsystems (leukapheresis collection, magnetic enrichment, cell modification) into a single device with unified control. This reduces system complexity by eliminating the need to coordinate multiple separate devices while maintaining the functional effectiveness of each subsystem through dedicated modules within the integrated platform.
Solution Approach 2:
The integrated device provides universal functionality for collection, enrichment, and modification operations. By consolidating these functions into one multi-functional system, the patent reduces overall system complexity while maintaining the effectiveness of each specific function through specialized modules designed within the unified platform.
4Ease of manufacture
If patient-disconnected processing is used with separate devices, then cell manipulation can be performed with dedicated equipment, but the risk of microbial contamination increases and cell delivery consistency is compromised
Solution Approach 1:
The system maintains continuous patient connection and continuous cell flow through the integrated device, eliminating interruptions and disconnections that occur with separate devices. This continuous operation minimizes exposure to microbial contamination while maintaining the specialized functionality needed for effective cell manipulation throughout the process.
Solution Approach 2:
The integrated device combines dedicated equipment for cell manipulation with continuous patient connection. By merging the specialized manipulation functions within a single integrated platform that maintains closed-loop connection, the system preserves the effectiveness of dedicated equipment while eliminating the contamination risks associated with patient disconnection and device transfer.
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
This approach reduces operating costs, minimizes product loss and contamination risks, ensures consistent cell delivery, and enhances efficiency by integrating collection, enrichment, and modification in a single device, maintaining a continuous flow.
Implementation Method 1
separating the blood components (e.g. based on density)
Implementation Method 2
which enrich PBPC based on a specific ligand (CD34, both devices and CD133 Miltenyi) on the cells' surface
Data Source
AI summary
Methods (300), devices, and systems of processing blood are described. The method (300) comprises the steps of: obtaining (312) blood from a patient coupled to a single blood processing device to form a closed loop between the patient and the blood processing device; collecting (314) bulk mononuclear blood cells from the blood by leukapheresis implemented using the blood processing device in the closed loop; and enriching (316) concurrently target cells separated from non-target cells in the bulk mononuclear blood cells using the blood processing device in the closed loop.