Spinning Membrane Separator for Automated Blood Component Processing
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Solution Overview
Problem
Current blood collection and processing methods are time-consuming, labor-intensive, and prone to human error, with a need for more efficient separation devices and systems for blood components like red cells and plasma.
Innovation Solution
A single-pass automated blood collection system using a spinning membrane separator with a reusable hardware component and a disposable fluid circuit, featuring a donor access device, anticoagulant source, and a blood separation device with rotating surfaces to separate whole blood into concentrated red cells and plasma, optionally including leukocyte filtration and data management systems.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Productivity
If manual blood collection and processing methods are used, then flexibility and adaptability are maintained, but time consumption and labor intensity increase significantly
Solution Approach 1:
The system divides the blood collection and processing function into separate modular components: a reusable hardware platform and disposable fluid circuits. This segmentation enables automated processing while maintaining flexibility, as different disposable circuits can be used for various blood processing tasks without redesigning the entire system.
Solution Approach 2:
The automated blood collection system performs separation and processing functions automatically without requiring manual intervention for each step. The system self-manages the collection, separation of blood components, and processing tasks, significantly reducing labor intensity and processing time while maintaining high productivity.
2Productivity
If automated blood separation devices are implemented, then processing speed and efficiency improve, but device complexity and initial costs increase
Solution Approach 1:
The system is divided into a complex reusable hardware platform that provides automated separation functionality and simpler disposable fluid circuits that are pre-assembled and single-use. This segmentation concentrates the complexity in the reusable portion while keeping the disposable portion simple, making the system more accessible and easier to use.
Solution Approach 2:
The reusable hardware platform is designed to be universal and multi-functional, capable of performing various blood processing tasks with different disposable fluid circuits. This universality justifies the initial investment in the reusable platform by enabling multiple applications and high-throughput processing across different scenarios.
3Reliability
If manual manipulation and assembly of fluid processing apparatus are required, then device simplicity is maintained, but human error and contamination risk increase
Solution Approach 1:
The disposable fluid circuits are pre-assembled in a controlled manufacturing environment with precise connections and proper configuration before sterilization. This preliminary assembly eliminates the need for manual manipulation and assembly during blood processing, significantly reducing human error and contamination risk while maintaining ease of operation through simple connection and use.
4Loss of time
If repeated centrifugation and manual manipulation are used for cell washing, then equipment simplicity is maintained, but time consumption and labor intensity increase
Solution Approach 1:
The disposable fluid circuit integrates multiple washing steps and centrifugation operations into a single pre-assembled unit that performs all cell washing operations automatically in sequence. This merging of multiple manual steps into one automated system dramatically reduces the time required for cell washing while increasing the extent of automation, eliminating repeated manual manipulation.
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 system enables efficient, automated 'chairside' collection and separation of red cells and plasma, reducing manual handling, costs, and error rates, while improving the efficiency of blood processing and data management.
Implementation Method 1
a blood separation device with rotating surfaces to separate whole blood into concentrated red cells and plasma
Implementation Method 2
at least one or which carries a porous membrane substantially permeable to plasma and substantially impermeable to red blood cells
Data Source
AI summary
A membrane separation device is disclosed along with systems and methods employing the device in blood processing procedures. In one embodiment, a spinning membrane separator is provided in which at least two zones or regions are created in the gap between the membrane and the shell, such that mixing of the fluid between the two regions is inhibited by a radial rib associated with the membrane that decreases the gap between the membrane and the shell to define two fluid regions, the ridge isolating the fluid in the two regions to minimize mixing between the two. Automated systems and methods are disclosed for separating a unit of previously collected whole blood into components, such as concentrated red cells and plasma, for collecting red cells and plasma directly from a donor in a single pass, and for cell washing. Data management systems and methods and priming methods are also disclosed.