Closed-Loop Blood Cell Processing for Concurrent Leukapheresis Enrichment
Find Innovative SolutionsGenerate Solutions
Solution Overview
Problem
Current leukapheresis processes are inefficient, time-consuming, and costly, with separate devices required for collection, enrichment, and modification, leading to potential microbial contamination, loss of valuable lymphocytes, and thrombocytopenia, and lack of a closed-loop, patient-connected system for concurrent processing.
Innovation Solution
A closed-loop, patient-connected device for concurrent leukapheresis, enrichment, and optional modification of target cells, allowing bulk mononuclear cells to be collected, enriched, and optionally modified within a single device, with non-target cells returned to the patient.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If separate devices are used for leukapheresis, enrichment, and modification, then each function can be performed by specialized equipment, but the process becomes time-consuming, costly, and prone to microbial contamination
Solution Approach 1:
The patent combines leukapheresis collection, cell enrichment, and cell modification functions into a single integrated device. The collection chamber receives blood, separates mononuclear cells, enriches target cells using magnetic beads, and modifies cells in the same continuous closed-loop system, eliminating the need for multiple separate devices and reducing contamination risk.
Solution Approach 2:
The single device performs multiple functions: it acts as a leukapheresis collector, an enrichment system using magnetic separation, and a modification chamber. This multi-functional approach allows the system to complete the entire cell processing workflow in one continuous operation without transferring cells between different devices.
2Productivity
If separate devices are used for cell processing, then each device can be optimized for its specific function, but operating costs increase and product loss occurs during transfers
Solution Approach 1:
The system maintains continuous blood flow through the collection chamber, enrichment system, and modification chamber in a closed-loop configuration. This continuous processing eliminates interruptions and transfers between devices, preventing cell loss and improving overall processing efficiency while reducing operating costs.
3Productivity
If a closed-loop continuous-flow system is implemented, then processing efficiency increases and contamination is reduced, but the device complexity increases
Solution Approach 1:
The integrated device is divided into distinct functional chambers: a collection chamber for leukapheresis, an enrichment chamber for magnetic separation, and a modification chamber. Each chamber performs a specific function while being part of the continuous closed-loop system, allowing modular design that manages complexity through functional segmentation.
4Measurement precision
If bulk mononuclear cells are collected and then enriched separately, then target cells can be isolated, but valuable lymphocytes are lost and the process becomes time-consuming
Solution Approach 1:
The system performs preliminary enrichment of target cells immediately after collection in the same device, using magnetic bead conjugation and separation. This preliminary action occurs while the system is already in operation, eliminating the need for separate enrichment steps and reducing overall processing time while maintaining high purity.
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 processing, and maintains patient safety by maintaining a continuous flow system for efficient cell collection and enrichment.
Implementation Method 1
The blood is normally separated into three fractions: RBC (about 45% of total blood), 'buffy coat' (less than 1% of total blood) and plasma (about 55% of total blood)
Implementation Method 2
Devices used for this purpose include, for example, the Baxter Isolex 300i and the Miltenyi CliniMACS, 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.