Closed Blood Collection Device Plasma Separation

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Solution Overview

Problem

Current blood sampling techniques are device-intensive, leading to increased time and cost, and point-of-care testing devices face challenges with inconsistent and inaccurate results due to manual, open-system sample collection and transfer.

Innovation Solution

A closed biological fluid collection and testing system that separates plasma from cellular components within a device, allowing for fast mixing with a sample stabilizer and transfer to a point-of-care testing device without exposure, incorporating a housing with an inlet port, flow channel, puncturing element, separation member, and wicking element for efficient blood collection and analysis.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If multiple intermediate devices (needles, vacuum tubes) are used for blood collection and transfer, then blood samples can be collected and transported, but the time and cost of the testing process increases

Engineering Contradiction:
Improveblood sample collectionVSAvoidtesting process time
Core Design Contradiction:
ReliabilityVSLoss of time

Solution Approach 1:

The patent combines multiple separate devices (collection device, transfer mechanism, and testing device) into a single integrated system. The collection device is directly coupled to the testing device, eliminating the need for separate vacuum tubes and manual transfer steps, thereby reducing both time and the number of intermediate devices required.

Inventive Principle:
Principle #5Merging (Combining)

Solution Approach 2:

The integrated system performs multiple functions within a single device: it collects blood samples, separates plasma from cellular components, and transfers the plasma to the testing device. This multi-functionality eliminates the need for separate collection and transfer devices, reducing overall process time.

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

2Reliability

If multiple intermediate devices are used for blood collection, then blood samples can be obtained, but the number of devices and complexity increases

Engineering Contradiction:
Improveblood sample collectionVSAvoidnumber of devices
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The patent merges the collection device, transfer mechanism, and testing device into a single integrated system. This consolidation reduces the number of separate devices from multiple intermediate components to one unified device, thereby reducing complexity while maintaining collection reliability.

Inventive Principle:
Principle #5Merging (Combining)

3Ease of operation

If manual open-system sample collection and transfer is used, then samples can be collected, but result accuracy and consistency deteriorate

Engineering Contradiction:
Improvesample collectionVSAvoidtest result accuracy
Core Design Contradiction:
Ease of operationVSMeasurement precision

Solution Approach 1:

The integrated system combines collection and testing functions with an automated transfer mechanism, eliminating manual open-system handling. This reduces contamination risks and variability introduced by manual operations, thereby improving result accuracy and consistency while maintaining ease of operation through automated processes.

Inventive Principle:
Principle #5Merging (Combining)

Solution Approach 2:

The automated transfer mechanism acts as an intermediary between the collection device and testing device, providing a controlled, closed-system transfer path. This intermediary mechanism ensures consistent, contamination-free sample transfer, improving measurement precision while requiring minimal user intervention.

Inventive Principle:
Principle #24Intermediary (Mediator)

4Reliability

If evacuated tubes are used for blood collection, then samples can be collected, but sample waste occurs

Engineering Contradiction:
Improveblood sample collectionVSAvoidblood sample waste
Core Design Contradiction:
ReliabilityVSLoss of substance

Solution Approach 1:

The integrated system is designed to collect only the necessary amount of blood required for the specific test, rather than using fixed-volume evacuated tubes. The system can adjust collection volume based on test requirements, thereby reducing sample waste while maintaining reliable collection for the intended purpose.

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

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 reduces blood sample exposure, provides accurate and reproducible results by enabling closed transfer of pure plasma to point-of-care testing devices, eliminating waste associated with evacuated tubes and improving ease of use for small sample tests.

Implementation Method 1

The wicking element includes a sample stabilizer disposed therewith

Methodology Applied
Scientific EffectCapillary action: Capillary Action

Implementation Method 2

a separation member disposed within the flow channel between the inlet port and the reservoir

Methodology Applied
Scientific EffectFiltration: Filter (physical)

Data Source

PatentEP2986220B1Biological fluid collection device and biological fluid collection and testing system
Publication Date: 2017.02.01 BECTON DICKINSON & CO
  • EP2986220B1 patent drawing
  • EP2986220B1 patent drawing
  • EP2986220B1 patent drawing

AI summary

A blood collection device adapted to receive a multi-component blood sample is disclosed. After collecting the blood sample, the blood collection device separates a plasma portion from a cellular portion. After separation, the blood collection device is able to transfer the plasma portion of the blood sample to a point-of-care testing device. The blood collection device of the present disclosure also provides a closed collection and transfer system that reduces the exposure of a blood sample and provides fast mixing of a blood sample with a sample stabilizer. The blood collection device is engageable with a blood testing device for closed transfer of a portion of the plasma portion from the blood collection 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.