Multi-Channel Bodily Fluid Collection Device for Low-Volume Sampling

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Solution Overview

Problem

Conventional blood sample collection techniques require high volumes of blood, making non-venous draws less favorable and increasing patient apprehension, while also adding complexity in separating samples for different processing methods.

Innovation Solution

A device with multiple sample collection channels and containers that allows for the accurate collection and separation of small blood volumes, enabling simultaneous or sequential filling of containers with different coatings to prevent mixing and premature clogging, and includes a method for introducing anti-coagulants to prevent clotting and facilitate sample transport.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Object-affected harmful factors

If non-venous puncture is used to extract blood sample, then patient discomfort is reduced, but the volume of blood obtained is insufficient for conventional testing

Engineering Contradiction:
Improvepatient discomfortVSAvoidblood volume
Core Design Contradiction:
Object-affected harmful factorsVSQuantity of substance

Solution Approach 1:

The device divides the blood collection process into multiple parallel channels, each collecting a portion of the total required blood volume. Multiple containers are used simultaneously to accumulate sufficient volume while maintaining low-volume draws from the patient site, thus reducing discomfort while achieving adequate total volume.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The collection device is designed with multiple containers that can be configured for different testing purposes. The system can collect blood into multiple containers simultaneously or sequentially, allowing the same non-venous draw to provide sufficient volume for multiple tests that would otherwise require separate venous draws.

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

2Adaptability or versatility

If blood sample is separated into different containers for different processing, then pre-analytical processing is improved, but collection complexity increases

Engineering Contradiction:
Improvepre-analytical processingVSAvoidcollection complexity
Core Design Contradiction:
Adaptability or versatilityVSDevice complexity

Solution Approach 1:

The device incorporates multiple containers within a single collection assembly, each container dedicated to specific processing requirements. This segmentation allows different blood portions to be directed to appropriate containers with suitable coatings or additives, simplifying the separation process while maintaining processing versatility.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The device combines multiple collection functions into a single integrated assembly that interfaces with one puncture site. The multiple containers are pre-configured within the device, merging the complexity of multiple collection procedures into one unified collection action, thereby reducing operational complexity while maintaining processing adaptability.

Inventive Principle:
Principle #5Merging (Combining)

3Reliability

If anti-coagulant is introduced early to prevent clotting, then sample transport reliability is improved, but channel clogging risk increases

Engineering Contradiction:
Improvesample transportVSAvoidchannel clogging
Core Design Contradiction:
ReliabilityVSObject-generated harmful factors

Solution Approach 1:

The device applies anti-coagulant coating selectively to specific channel surfaces rather than uniformly throughout. This localized application prevents clotting in critical areas while minimizing excessive coating that could cause clogging. Different channel regions receive appropriate coating densities based on their functional requirements.

Inventive Principle:
Principle #3Local quality

Solution Approach 2:

The device controls the concentration and distribution of anti-coagulant material within the channels. By optimizing the amount and placement of anti-coagulant, the system achieves sufficient clot prevention for reliable transport while avoiding excessive material that could precipitate or cause channel obstruction.

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 efficient collection and processing of small blood volumes from non-venous sites with reduced patient discomfort and complexity, allowing for effective separation and transport of samples without premature clogging or mixing.

Implementation Method 1

at least two of the channels are configured to simultaneously draw the fluid sample into each of the at least two sample collection channels via a first type of motive force

Methodology Applied
Scientific EffectCapillary action: Capillary Action

Implementation Method 2

the sample containers have a first condition where the sample containers are not in fluid communication with the sample collection channels, and a second condition where the sample containers are operably engagable to be in fluid communication with the collection channels, whereupon when fluid communication is established, the containers provide a second motive force different from the first motive force to move bodily fluid sample from the channels into the containers

Methodology Applied
Scientific EffectVacuum: Vacuum

Data Source

PatentEP4098239A1Systems, devices, and methods for bodily fluid sample collection
Publication Date: 2022.12.07 LABRADOR DIAGNOSTICS LLC
  • EP4098239A1 patent drawingFigure 1A~1B
  • EP4098239A1 patent drawingFigure 2A~2C
  • EP4098239A1 patent drawingFigure 3A~3B

AI summary

A device (1290) for collecting a bodily fluid sample from a subject, the device comprising: a collection portion for drawing the bodily fluid sample into the device from a single end of the device in contact with the subject, the collection portion comprising a plurality of tissue penetrating members (1292) and an actuation mechanism (1291); a sample storage portion (1296) for receiving the fluid sample from the collection portion.