Apheresis Kit Flow Circuit for Flush and Divert Prime Stage
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Solution Overview
Problem
Current blood treatment systems require separate, differently configured disposable fluid processing assemblies for replacement fluid therapeutic plasma exchange (TPE) and plasma adsorption TPE, leading to issues such as unintended mixing of red blood cells and plasma when trying to use a disposable assembly designed for replacement fluid TPE in plasma adsorption TPE.
Innovation Solution
A blood treatment system with a reusable separation device and a flow circuit that includes a plurality of cassettes, a separation chamber, and tubings, configured to perform both replacement fluid TPE and adsorption TPE procedures by switching between configurations, including a flush step and a divert prime step, to prevent backflow and ensure proper fluid handling.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Adaptability or versatility
If a disposable fluid processing assembly designed for replacement fluid TPE is used in plasma adsorption TPE, then the system can perform adsorption procedures, but unintended mixing of red blood cells and plasma occurs
Solution Approach 1:
The flow circuit is divided into distinct segments with dedicated pathways: a first fluid pathway for replacement fluid TPE and a second fluid pathway for plasma adsorption TPE. This segmentation prevents mixing of blood components by ensuring that red blood cells and plasma travel through separate, isolated routes throughout the system.
Solution Approach 2:
A check valve is introduced as an intermediary component in the plasma tubing to control unidirectional flow. This intermediary device prevents backflow of plasma into the red blood cell compartment, ensuring that the two blood components remain separated and do not mix unintentionally during procedure transitions.
2Reliability
If separate disposable fluid processing assemblies are used for replacement fluid TPE and plasma adsorption TPE, then each procedure has optimized configuration, but device complexity and operational efficiency decrease
Solution Approach 1:
A single disposable fluid processing assembly is designed with multi-functionality to accommodate both replacement fluid TPE and plasma adsorption TPE procedures. The assembly includes a dual-pathway fluid circuit with a check valve, enabling it to perform multiple functions that previously required separate specialized assemblies, thereby reducing overall system complexity.
Solution Approach 2:
The flow circuit incorporates a check valve that dynamically controls flow direction based on procedure requirements. During replacement fluid TPE, the check valve allows flow in one direction, while during plasma adsorption TPE, it switches to prevent backflow, adapting the circuit configuration dynamically without requiring physical reconfiguration of the disposable assembly.
3Productivity
If a single flow circuit is used for both replacement fluid TPE and plasma adsorption TPE, then operational efficiency improves, but risk of unintended mixing increases
Solution Approach 1:
The flow circuit is divided into distinct segments with dedicated pathways: a first fluid pathway for replacement fluid TPE and a second fluid pathway for plasma adsorption TPE. This segmentation prevents mixing of blood components by ensuring that red blood cells and plasma travel through separate, isolated routes throughout the system.
Solution Approach 2:
A check valve is introduced as an intermediary component in the plasma tubing to control unidirectional flow. This intermediary device prevents backflow of plasma into the red blood cell compartment, ensuring that the two blood components remain separated and do not mix unintentionally during procedure transitions.
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 effectively performs both replacement fluid TPE and plasma adsorption TPE procedures without the risk of unintended mixing of blood components, by utilizing a single flow circuit that can be reconfigured to accommodate different procedures, thus enhancing operational efficiency and safety.
Implementation Method 1
As the whole blood is spun by the centrifuge, the heavier (greater specific gravity) components, such as red blood cells, move radially outwardly away from the center of rotation toward the outer or 'high-G' wall of a separation chamber included as part of the fluid processing assembly. The lighter (lower specific gravity) components, such as plasma, migrate toward the inner or 'low-G' wall of the separation chamber.
Implementation Method 2
The adsorption device will remove undesirable substances from the plasma by immuno-adsorption. The exact substances removed depend upon the needs of the patient. For example, the substances removed from the plasma by the adsorption device may include low-density lipoproteins and Lipoprotein (a) for patients suffering from severe hypercholesterolemia.
Data Source
AI summary
A flow circuit for a blood treatment system includes flow cassettes, a separation chamber fluidically connected to the cassettes, tubings fluidically connecting the cassettes and the separation chamber, the tubings including a plasma tubing including a first column connector, a Luer activated port, and a check valve. The flow circuit has a first configuration for a replacement fluid therapeutic plasma exchange procedure in which the first column connector has first and second mating parts connected to one another, and a second configuration for an adsorption therapeutic plasma exchange procedure in which the flow circuit further comprises an adsorption device having a second column connector and the adsorption device is connected in line with plasma tubing and the first and second mating parts of the first column connector are connected to corresponding first and second parts of the second column connector.