Blood Separation Device Decouples Collection From Plasma Processing
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Solution Overview
Problem
Existing blood separation technologies face challenges such as poor plasma purity, analyte bias, high hemolysis, and patient discomfort due to the need for centrifugation and specific coatings, as well as being affected by needle gauge and blood pressure during plasma separation.
Innovation Solution
A blood separation device that decouples the blood collection process from plasma separation, allowing for immediate plasma separation after disconnection from the patient, using a sample collection module, activation module, and separation module without the need for centrifugation or power, and utilizing a track-etched membrane for separation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Productivity
If plasma separation is performed during blood collection through a needle, then separation can occur in real-time, but patient discomfort increases and separation performance is affected by needle gauge and blood pressure
Solution Approach 1:
The device is divided into distinct functional modules: a blood collection module with needle and a plasma separation module. This segmentation allows the separation process to occur in a dedicated chamber away from the patient, eliminating the harmful effects of in-line separation while maintaining real-time separation capability through immediate post-collection processing.
Solution Approach 2:
A separation chamber acts as an intermediary between blood collection and plasma analysis. The chamber receives whole blood from the collection needle and provides a controlled environment for plasma separation using a separation member, isolating the separation process from direct patient contact and eliminating the adverse effects of needle-based in-line separation.
2Reliability
If centrifugation is used for plasma separation, then plasma can be separated effectively, but the process takes 15-20 minutes and requires heavy labor or complex workflow
Solution Approach 1:
The patent replaces the complex mechanical centrifugation system with a passive separation mechanism using a separation member (membrane or filter) in the separation chamber. This substitution eliminates the need for heavy centrifugal force generation, reduces operational complexity, and enables rapid plasma separation without requiring 15-20 minutes of centrifugation time.
Solution Approach 2:
The separation chamber is designed to perform plasma separation automatically as blood flows through it, without requiring external centrifugal force or complex operational intervention. The separation member passively filters plasma from whole blood as it passes through the chamber, enabling the system to serve itself and eliminate time-consuming manual centrifugation processes.
3Productivity
If membrane-based separation technologies are used, then plasma separation can occur, but analyte bias problem arises requiring specific coating treatments
Solution Approach 1:
The patent employs a separation member with specifically controlled pore size and material properties to minimize analyte bias. By changing the physical parameters of the separation member (pore diameter, material composition, surface charge), the device achieves effective plasma separation without requiring complex coating treatments, thereby maintaining both separation capability and plasma purity.
4Productivity
If conventional separation technologies are used during patient connection, then plasma can be separated, but hemolysis increases and plasma recovery becomes difficult
Solution Approach 1:
The separation chamber serves as an intermediary that receives blood from the collection needle and provides a low-shear, controlled separation environment. This intermediary chamber prevents the high-shear forces and turbulent flow that cause hemolysis in conventional in-line separation systems, while still enabling effective plasma separation through the separation member.
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 patient discomfort, improves plasma quality and yield, and enables high-volume plasma applications by isolating plasma separation from blood collection processes, unaffected by needle gauge and blood pressure, while maintaining a short on-patient collection time similar to conventional methods.
Implementation Method 1
the first seal transitionable from a closed position in which the collection chamber has a first pressure to an open position, by actuation of a portion of the activation module, in which the collection chamber is in fluid communication with a second pressure greater than the first pressure
Implementation Method 2
a separation module in fluid communication with the collection chamber of the sample collection module, the separation module may be defined as a first chamber having a first volume and a second chamber having a second volume and including a separation member disposed between the first chamber and the second chamber
Data Source
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AI summary
A blood separation device that decouples and separates the blood collection process from the plasma separation process is disclosed. The blood separation device includes a sample collection module, an activation module, and a separation module. Because the plasma separation happens after the blood separation device is disconnected from a patient, the device performance is no longer affected by patient blood pressure and needle gauge, and patient discomfort is greatly reduced.