Needle-Free Capillary Blood Collection Device with Integrated Stabilization

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Solution Overview

Problem

Current devices for collecting biological samples, such as blood, are cumbersome, require trained personnel, and often result in excessive sample collection, with a lack of immediate stabilization capabilities for molecular diagnostic tests.

Innovation Solution

A device comprising a housing, a retainer with a solution, and a collector with an absorbent member that facilitates easy sample collection and mixing with additives for stabilization, allowing self-collection and integration with automated testing systems.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If venous collection tubes with needles are used, then sample collection is reliable and additives are effectively delivered, but the procedure requires trained personnel and carries puncture risks

Engineering Contradiction:
Improvesample collection reliabilityVSAvoidease of operation
Core Design Contradiction:
ReliabilityVSEase of operation

Solution Approach 1:

The invention extracts the needle component from the collection system, replacing it with a needle-free capillary tube insertion method. The capillary tube is inserted directly into a vein or vessel without requiring needle puncture, thereby maintaining reliable sample collection while eliminating the need for trained personnel and removing puncture risks.

Inventive Principle:
Principle #2Taking out (Extraction)

Solution Approach 2:

The invention introduces a intermediary device - a holder with a capillary tube - that mediates between the user and the blood collection process. The holder guides the capillary tube into the vein and contains the stabilization buffer, serving as an intermediary that simplifies operation while ensuring reliable sample collection and additive delivery.

Inventive Principle:
Principle #24Intermediary (Mediator)

2Ease of operation

If capillary tube based collection devices are used, then the procedure is simpler and safer, but the volume of sample collected is insufficient for molecular diagnostic tests

Engineering Contradiction:
Improveease of operationVSAvoidsample volume
Core Design Contradiction:
Ease of operationVSQuantity of substance

Solution Approach 1:

The invention makes the capillary tube dynamic by allowing it to extend beyond the holder after insertion. The flexible capillary tube can be advanced further into the vessel to collect additional sample volume as needed, transforming a static short tube into a dynamic collection system that can adapt to volume requirements for molecular diagnostic tests.

Inventive Principle:
Principle #15Dynamics

3Reliability

If immediate mixing with stabilization buffer is required, then molecular diagnostic sample quality is improved, but current collection devices lack integrated mixing capability

Engineering Contradiction:
Improvesample stabilization qualityVSAvoiddevice complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The invention merges the sample collection function and the stabilization buffer storage function into a single integrated device. The holder contains both the capillary tube for sample collection and the stabilization buffer reservoir, combining multiple functions into one device rather than requiring separate collection and mixing steps.

Inventive Principle:
Principle #5Merging (Combining)

Solution Approach 2:

The invention prepares the stabilization buffer in advance within the holder, positioned to be immediately delivered to the collected sample. The buffer is pre-loaded and positioned so that as soon as blood enters the capillary tube, the stabilization buffer is already in place to mix and stabilize the sample, ensuring immediate stabilization without requiring additional mixing actions.

Inventive Principle:
Principle #10Preliminary action

4Quantity of substance

If excessive sample is collected with traditional devices, then sufficient sample is available for testing, but sample waste increases and handling becomes more difficult

Engineering Contradiction:
Improvesample availabilityVSAvoidsample waste
Core Design Contradiction:
Quantity of substanceVSLoss of substance

Solution Approach 1:

The invention changes the volume parameter of the collection system by using a smaller capillary tube with controlled internal diameter. This parameter change allows collection of only the necessary sample volume required for molecular diagnostic tests, rather than collecting excessive amounts with traditional larger tubes, thereby reducing sample waste while ensuring sufficient sample availability.

Inventive Principle:
Principle #35Parameter changes

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

Enables simplified, efficient collection and stabilization of biological samples, particularly for molecular diagnostics, allowing for immediate stabilization and easy handling by patients or medical personnel, with integration into standard laboratory processes.

Implementation Method 1

Capillary tube based collection devices are used to collect a small volume of blood from a patient's fingertip or heel. These devices usually function by holding the tip of an open end capillary tube against the drop of fluid and the fluid is then drawn into the tube using capillary forces.

Methodology Applied
Scientific EffectCapillary action: Capillary Action

Implementation Method 2

the inwardly recessed central portion or the protrusion of the closed bottom of the vessel compresses the absorbent member when the collector is engaging or engaged with the open end portion of the housing, thereby squeezing the biological sample out of the absorbent member

Methodology Applied
Scientific EffectCompression: Compression

Data Source

PatentEP3154696B1Devices and methods for collecting and stabilizing biological samples
Publication Date: 2020.04.08 DXTERITY DIAGNOSTICS INC
  • EP3154696B1 patent drawingFigure 1A~1B
  • EP3154696B1 patent drawingFigure 1C~1D
  • EP3154696B1 patent drawingFigure 2A~2B

AI summary

The present invention generally relates to devices and methods for collecting and stabilizing biological samples, and more particularly, for collecting and stabilizing blood or other bodily fluids from a user's fingertip, earlobe, heel or other locations. The present invention also relates to sample collection devices that simplify the process for mixing the biological samples with an additive or additives, provide for efficient storage and safe transport of the samples, and provide for easy access to the samples for subsequent processing.