Automated Red Blood Cell Additive Volume Determination
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Solution Overview
Problem
Current blood processing methods are labor-intensive, time-consuming, and prone to human error due to the manual separation and processing of blood components, which limits the ability to standardize hematocrit levels in red blood cell products.
Innovation Solution
A system comprising a durable hardware component with a separator and controller, integrated with a disposable fluid flow circuit, that automatically separates target blood components and adds a custom amount of additive solution to achieve specific collection parameters, such as target hematocrit levels.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If manual collection and processing methods are used, then flexibility in handling blood components is maintained, but labor intensity and time consumption increase significantly
Solution Approach 1:
The system enables automated self-service processing where the blood processing system automatically performs separation, measurement, and additive solution addition without requiring manual intervention at each step, thereby increasing productivity while maintaining operational simplicity through centralized control
Solution Approach 2:
Manual mechanical operations are replaced with an automated system that uses electronic control, automated measurement devices, and programmable additive solution delivery mechanisms to perform blood component processing, significantly improving processing efficiency
2Ease of manufacture
If pre-determined fixed volume of additive solution is added, then the process is simplified, but hematocrit standardization cannot be achieved
Solution Approach 1:
The system dynamically adjusts the additive solution volume parameter based on measured RBC volume and desired hematocrit target, replacing the fixed pre-determined volume approach with a variable parameter control strategy that achieves hematocrit standardization while maintaining process simplicity through automated calculation and delivery
3Manufacturing precision
If automated system with customized additive solution addition is implemented, then hematocrit standardization and precision are improved, but system complexity increases
Solution Approach 1:
The automated system integrates multiple functions including RBC separation, RBC volume measurement, additive solution volume calculation, and precise additive delivery into a single multi-functional platform, reducing the need for separate equipment and operations despite the increased precision capabilities
Solution Approach 2:
The system uses feedback from automated RBC volume measurement to dynamically calculate and adjust the additive solution volume required to achieve the target hematocrit, implementing closed-loop control that ensures precision while automating the complexity of calculations and adjustments
4Adaptability or versatility
If multiple operator interactions are required, then manual control and adaptability are maintained, but human error and time consumption increase
Solution Approach 1:
The system performs automated measurements, calculations, and additive solution additions without requiring multiple operator interactions, eliminating human error sources while maintaining the ability to handle different blood components and processing scenarios through programmable versatility
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 automated and customized blood processing, reducing human error and improving efficiency by allowing precise control over the volume of additive solution added to blood components, thereby standardizing product quality.
Implementation Method 1
The whole blood is typically first collected in what is called a primary collection container... The whole blood is typically first collected in what is called a primary collection container that also contains an anticoagulant... The whole blood is typically first collected in what is called a primary collection container that also contains an anticoagulant, such as but not limited to a solution of sodium citrate, phosphate, and dextrose ('CPD'). After initial collection, it is a common practice to transport the collected whole blood to another facility or location, sometimes called a 'back lab,' for further processing to separate red blood cells ('RBCs'), platelet, and plasma from the whole blood... The processing usually entails manually loading the primary collection container and associated tubing and satellite containers into a centrifuge to separate the whole blood into concentrated red cells and platelet-rich or platelet-poor plasma.
Implementation Method 2
The volume of pure RBCs in a unit of whole blood is dependent on the hematocrit of the donation, which is often unknown...
Data Source
AI summary
Automated blood processing systems and methods including a durable hardware component, a single use fluid flow circuit, and a controller configured to determine and add a custom amount of additive solution. More particularly, systems and methods for adding a custom amount of a red blood cell (RBC) additive solution to obtain a target RBC product with a target hematocrit.