Closed Blood Sampling Device Plasma Separation

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Solution Overview

Problem

Current blood sampling techniques are device-intensive, time-consuming, and costly, with open systems leading to inconsistent results and increased exposure of blood samples, especially when transferring samples to point-of-care testing devices.

Innovation Solution

A closed biological fluid sampling and transfer system that separates plasma from cellular components within a device, allowing for fast mixing with a sample stabilizer and direct transfer to point-of-care testing devices without external machinery, reducing exposure and minimizing waste.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If traditional open blood sampling systems are used with multiple devices, then blood samples can be collected and transferred, but sample exposure increases and process time increases

Engineering Contradiction:
Improvesample safetyVSAvoidprocess time
Core Design Contradiction:
ReliabilityVSLoss of time

Solution Approach 1:

The patent combines multiple separate devices (collection device, separation device, transfer device) into a single integrated closed system. The collection tube, separation element, and transfer mechanism are merged into one unit that maintains sample containment throughout the entire process, eliminating the need to transfer samples between multiple open devices and thereby reducing both exposure time and total process time.

Inventive Principle:
Principle #5Merging (Combining)

Solution Approach 2:

The patent introduces a closed system as an intermediary between the blood collection needle and the testing device. This closed system acts as a mediator that maintains sample containment while enabling the necessary operations of collection, separation, and transfer, thus improving sample safety without increasing process time.

Inventive Principle:
Principle #24Intermediary (Mediator)

2Ease of operation

If traditional blood sampling with multiple devices is used, then blood collection is possible, but device complexity increases and cost increases

Engineering Contradiction:
Improvesampling simplicityVSAvoidnumber of devices
Core Design Contradiction:
Ease of operationVSDevice complexity

Solution Approach 1:

The patent merges the collection device, separation device, and transfer device into a single integrated unit. This combination reduces the number of separate devices from three or more to one, simplifying the overall system while maintaining all necessary functions. The integrated design makes the sampling process easier to operate as clinicians need to handle fewer components.

Inventive Principle:
Principle #5Merging (Combining)

Solution Approach 2:

The integrated device performs multiple functions within a single unit: it collects blood samples, separates plasma from cellular components, and transfers the plasma to testing devices. This multi-functionality eliminates the need for multiple specialized devices, reducing device complexity while maintaining ease of operation.

Inventive Principle:
Principle #6Universality (Multi-functionality)

3Measurement precision

If open blood sampling systems are used, then blood samples can be transferred to testing devices, but sample exposure increases leading to inconsistent results

Engineering Contradiction:
Improvetesting accuracyVSAvoidsample exposure
Core Design Contradiction:
Measurement precisionVSObject-affected harmful factors

Solution Approach 1:

The closed system serves as a protective intermediary that maintains sample containment during collection, separation, and transfer. This intermediary prevents exposure to harmful factors (contamination, degradation) that would otherwise occur in open systems, thereby ensuring consistent and accurate test results.

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The patent extracts the plasma portion from the blood sample within the closed system using a separation element, and immediately transfers it to the testing device without exposing the sample to the external environment. This extraction and immediate transfer within the closed system eliminates exposure-related inconsistencies.

Inventive Principle:
Principle #2Taking out (Extraction)

4Loss of substance

If traditional blood sampling methods are used, then blood collection is possible, but waste is generated from unused blood portions

Engineering Contradiction:
Improveblood wasteVSAvoidsampling efficiency
Core Design Contradiction:
Loss of substanceVSProductivity

Solution Approach 1:

The patent extracts only the necessary plasma portion from the blood sample using a separation element integrated into the collection device. This selective extraction allows the system to use only the required amount of blood for testing, eliminating waste of the cellular portion that would otherwise be discarded in traditional methods where entire samples must be collected in larger volumes.

Inventive Principle:
Principle #2Taking out (Extraction)

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 provides a safe, reproducible, and accurate process for blood sampling by reducing sample exposure, enabling integrated collection and plasma creation without centrifugation, and minimizing process time while eliminating waste associated with traditional methods.

Implementation Method 1

a separation element disposed between the inlet port and the transfer port. The separation element is adapted to restrain a first component of the multi-component blood sample and allow a second component of the multi-component blood sample to pass therethrough

Methodology Applied
Scientific EffectDensity Gradient: Density Gradient

Implementation Method 2

a mixing channel in fluid communication with the inlet port and the transfer port and shaped to promote mixing of the blood sample

Methodology Applied
Scientific EffectTurbulence: Turbulence

Data Source

PatentEP2986380B1Biological fluid sampling, separation and testing system
Publication Date: 2023.07.05 BECTON DICKINSON & CO
  • EP2986380B1 patent drawingFigure 1~2
  • EP2986380B1 patent drawingFigure 3
  • EP2986380B1 patent drawingFigure 4

AI summary

A biological fluid sampling transfer device adapted to receive a multi-component blood sample is disclosed. After collecting the blood sample, the biological fluid sampling transfer device is able to separate a plasma portion from a cellular portion. After separation, the biological fluid sampling transfer device is able to transfer the plasma portion of the blood sample to a point-of-care testing device. The biological fluid sampling transfer device also provides a closed sampling and transfer system that reduces the exposure of a blood sample and provides fast mixing of a blood sample with a sample stabilizer. The biological fluid sampling transfer device is engageable with a blood testing device for closed transfer of a portion of the plasma portion from the biological fluid sampling transfer device to the blood testing device. The blood testing device is adapted to receive the plasma portion to analyze the blood sample and obtain test results.