Density Phase Separation Device for Blood Samples
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Solution Overview
Problem
Conventional blood sample separation devices using thixotropic gels or mechanical barriers face issues such as limited shelf-life, chemical reactions with analytes, clogging, and complex manufacturing processes, leading to inefficient separation and potential contamination.
Innovation Solution
A mechanical separator device with a float and ballast system that moves within a collection container under centrifugal force, separating blood samples into higher and lower density phases without requiring piercing and minimizing cross-contamination, using materials like thermoplastic elastomers and mineral-filled polypropylene for stability and compatibility.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If thixotropic gel materials are used as separation barriers, then separation effectiveness is improved, but shelf-life is limited and chemical reactions with analytes occur
Solution Approach 1:
The patent employs a disposable plastic barrier component that is discarded after a single use, eliminating the need for long-term shelf-life preservation. This disposable barrier is made from inert materials that do not chemically react with analytes, solving both the shelf-life limitation and chemical reaction issues while maintaining separation effectiveness during the brief period when the device is in use.
Solution Approach 2:
The patent replaces the chemical thixotropic gel barrier system with a mechanical plastic barrier component. This substitution eliminates the chemical reactions between gel and analytes while providing a stable, inert separation interface that maintains its structural integrity without requiring long-term shelf-life preservation, as it is designed for single-use disposal.
2Reliability
If gel-based separators are used, then separation is achieved, but globules are released over time causing contamination
Solution Approach 1:
The disposable plastic barrier is designed to maintain its structural integrity throughout the brief period when the device is in use, preventing globule release and contamination. After serving its separation function, the barrier is discarded, eliminating any risk of long-term degradation or globule release that would occur with gel-based systems.
Solution Approach 2:
The patent replaces the gel-based barrier with a rigid plastic barrier component that does not degrade or release globules over time. This mechanical substitution provides a stable separation interface that prevents contamination while maintaining separation effectiveness, as the plastic material does not have the temporal degradation characteristics of gel.
3Reliability
If conventional mechanical separators are positioned above the collected whole blood specimen, then separation orientation is improved, but device complexity and manufacturing difficulty increase
Solution Approach 1:
Instead of positioning the mechanical separator above the blood specimen as in conventional designs, the patent inverts the configuration by positioning the barrier component at the bottom of the collection tube. This inversion simplifies the attachment mechanism to a straightforward snap-fit design and eliminates the need for complex mechanical interlocks, while still achieving proper separation orientation through the reversed spatial arrangement.
Solution Approach 2:
The patent divides the separation device into distinct functional segments: a collection tube, a removable barrier component, and a closure assembly. This segmentation allows the barrier to be independently manufactured with simple snap-fit attachments to the tube and closure, reducing overall device complexity while maintaining proper separation orientation through the modular arrangement of these segments.
4Reliability
If bellows components are used in mechanical separators, then sealing is achieved, but sample pooling and premature separator release occur
Solution Approach 1:
The disposable plastic barrier component is designed with a simple snap-fit attachment that prevents sample pooling and premature release during the brief collection period. After use, the entire barrier assembly is discarded, eliminating any risk of long-term sealing degradation or sample contamination that would occur with reusable bellows-based systems.
Solution Approach 2:
The patent replaces the complex bellows-based sealing mechanism with a simple plastic barrier component that uses elastic deformation for sealing. This substitution eliminates the sample pooling and premature release issues associated with bellows while maintaining effective sealing during the collection period, as the plastic material provides sufficient seal integrity without the mechanical complexity of bellows.
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 device effectively separates blood components without interfering with analytes, reduces sample pooling, and simplifies manufacturing, providing a stable and efficient method for separating serum and plasma from whole blood.
Implementation Method 1
the device and fluid sample are subjected to centrifugation in order to cause separation of the higher density fraction from the lower density fraction of the fluid sample
Implementation Method 2
separating blood samples into higher and lower density phases
Data Source
AI summary
A mechanical separator for separating a fluid sample into first and second phases within a collection container is disclosed. The mechanical separator may have a separator body having a through-hole defined therein, with the through-hole adapted for allowing fluid to pass therethrough. The separator body includes a float, having a first density, and a ballast, having a second density greater than the first density. A portion of the float is connected to a portion of the ballast. Optionally, the float may include a first extended tab adjacent a first opening of the through-hole and a second extended tab adjacent the second opening of the through-hole. In certain configurations, the separator body also includes an extended tab band disposed about an outer surface of the float. The separator body may also include an engagement band circumferentially disposed about at least a portion of the separator body.