Fecal Sample Collection Device with Volumetric Disruptor

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Solution Overview

Problem

Current methods for collecting and transporting fecal samples are inconvenient, costly, and prone to contamination, failing to provide a consistent, measurable, and preserved sample for metagenomic analysis, which is essential for understanding the microbiome's role in human health and disease.

Innovation Solution

A device comprising a collection vial with a volumetric disruptor and cap, equipped with a mixing mechanism like metal ball bearings, allows for the reproducible collection and homogenization of fecal samples, providing leakproof transport and storage while maintaining sample integrity and ease of use.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If fecal samples are collected using current standard methods (small tub kept frozen on dry ice), then the sample is preserved, but the storage and transport becomes inconvenient and costly

Engineering Contradiction:
Improvesample preservationVSAvoidstorage and transport convenience
Core Design Contradiction:
ReliabilityVSEase of operation

Solution Approach 1:

The patent changes the temperature parameter from frozen (-78°C on dry ice) to refrigerated (2-8°C), allowing samples to be stored and transported without freezing while maintaining preservation. The collection device includes a stabilizing solution that chemically preserves nucleic acids at refrigerated temperatures, eliminating the need for frozen storage.

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The patent introduces a stabilizing solution as an intermediary substance that chemically preserves the fecal sample and nucleic acids. This solution allows the sample to remain stable at refrigerated temperatures during transport, acting as a mediator between the biological sample and the storage conditions.

Inventive Principle:
Principle #24Intermediary (Mediator)

2Reliability

If the entire fecal sample is collected in a small tub, then the sample is preserved, but obtaining a secondary consistently sized sample requires thawing and messy transfer

Engineering Contradiction:
Improvesample preservationVSAvoidsampling process complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The patent segments the sampling process by providing pre-portioned collection tubes with specific volumes (e.g., 2mL, 5mL, 10mL). Each tube is designed to collect a consistent, measurable amount of sample, eliminating the need for secondary sampling and transfer operations.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The collection tubes are pre-prepared with stabilizing solution and volume markings before use. This preliminary preparation ensures that when the sample is collected, the correct volume is already established and preserved, eliminating the need for subsequent thawing, measuring, and transfer steps.

Inventive Principle:
Principle #10Preliminary action

3Reliability

If fecal samples are collected for metagenomic analysis, then microbiome study is enabled, but contamination risk increases

Engineering Contradiction:
Improvemicrobiome analysis accuracyVSAvoidcontamination risk
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent creates an inert environment by using sterilized collection tubes with stabilizing solution that prevents microbial growth and contamination. The sealed tube design maintains this sterile environment throughout collection and transport, protecting the sample from external contaminants.

Inventive Principle:
Principle #39Inert atmosphere (Inert environment)

Solution Approach 2:

The patent employs disposable, single-use collection tubes that are sterilized and discarded after one use. This eliminates cross-contamination between samples and simplifies contamination control, as each tube is used only once and then disposed of in a biohazard container.

Inventive Principle:
Principle #27Cheap short-living objects (Disposable)

4Reliability

If complex collection steps are required, then sample quality may improve, but donor participation decreases

Engineering Contradiction:
Improvesample qualityVSAvoiddonor ease of use
Core Design Contradiction:
ReliabilityVSEase of operation

Solution Approach 1:

The patent creates a universal collection system where a single tube design handles multiple functions: collection, stabilization, volume measurement, and transport. The tube works for all sample types and volumes, simplifying the process for donors while maintaining sample quality through integrated stabilizing solution.

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

Solution Approach 2:

The collection tube is designed to be self-contained and easy for donors to use independently. The tube includes clear volume markings and stabilizing solution that automatically preserves the sample upon collection, requiring no special skills or equipment from the donor.

Inventive Principle:
Principle #25Self-service

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 enables convenient, cost-effective, and contamination-free collection and transportation of fecal samples, ensuring a high-quality, stable sample for analysis, facilitating the study of the microbiome's role in health and disease.

Implementation Method 1

equipped with a mixing mechanism like metal ball bearings, allows for the reproducible collection and homogenization of fecal samples

Methodology Applied
Scientific EffectMechanical mixing: Stirring

Implementation Method 2

The tube may further comprise a composition for preserving and stabilizing the biomolecule therein

Methodology Applied
Scientific EffectChemical preservation: Preservative

Data Source

PatentEP3146307B1Device for collecting, transporting and storing biomolecules from a biological sample and corresponding method
Publication Date: 2022.03.23 DNA GENOTEK
  • EP3146307B1 patent drawingFigure 1
  • EP3146307B1 patent drawingFigure 2
  • EP3146307B1 patent drawingFigure 3

AI summary

The present application provides a sample receiving device comprising a vial, a receptacle in communication with the vial for receiving the sample, and a cap comprising a pusher, the pusher for engaging with the sample in the receptacle. The receptacle comprises a disrupting means for disrupting the sample when the pusher engages with the sample in the receptacle and expels the disrupted sample into the vial. Typically, the device can be used for collecting fecal samples. A method of preserving a biomolecule in the device using a biomolecule preserving composition is also provided.