Flexible Blister for Segmented Nucleic Acid Processing

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Solution Overview

Problem

Current nucleic acid testing (NAT) assays are complex, require specialized facilities and personnel, and are not suitable for field-testing or resource-limited settings due to contamination risks and high costs, limiting their use in areas like developing countries.

Innovation Solution

A device with a flexible blister that can be divided into sealed regions using external pressure, allowing for on-site sample processing with retained reagents, reducing contamination risks and simplifying the device structure, enabling automated processing and analysis within a single enclosure.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If current NAT assay procedures are used, then nucleic acid detection sensitivity is improved, but device complexity and requirement for specialized facilities increase

Engineering Contradiction:
Improvenucleic acid detection sensitivityVSAvoidassay procedure complexity
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The device divides the single enclosure into multiple sealed regions using flexible membranes, with each region containing specific reagents or sample compartments. This segmentation allows complex multi-step NAT procedures to be performed in separate isolated zones while maintaining overall device simplicity and portability.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The patent employs a nested structure where multiple sealed regions are contained within a single enclosure. The flexible membranes create hierarchical containment, allowing the device to integrate multiple assay steps (extraction, amplification, detection) in a compact nested arrangement that reduces overall complexity.

Inventive Principle:
Principle #7Nested doll (Nesting)

2Measurement precision

If current NAT assay procedures are used, then nucleic acid detection sensitivity is improved, but the risk of amplicon contamination increases

Engineering Contradiction:
Improvenucleic acid detection sensitivityVSAvoidamplicon contamination risk
Core Design Contradiction:
Measurement precisionVSObject-affected harmful factors

Solution Approach 1:

The device creates physically separated sealed regions for different assay steps, isolating amplicon generation zones from sample preparation and detection zones. This spatial segmentation prevents amplicon carryover contamination while maintaining the sensitivity required for nucleic acid detection.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

Flexible membranes act as intermediaries between sealed regions, allowing controlled transfer of samples or reagents while maintaining physical barriers that prevent contamination. The membranes enable selective permeability or controlled breaking to transfer contents without exposing adjacent regions to contaminants.

Inventive Principle:
Principle #24Intermediary (Mediator)

3Measurement precision

If current NAT assay procedures are used, then detection accuracy is improved, but the cost of reagents and equipment increases

Engineering Contradiction:
Improvedetection accuracyVSAvoidreagent cost
Core Design Contradiction:
Measurement precisionVSQuantity of substance

Solution Approach 1:

The device combines multiple reagents, samples, and assay steps into a single integrated enclosure with multiple sealed regions. This merging eliminates the need for multiple separate containers and equipment, reducing overall reagent consumption and equipment costs while maintaining detection accuracy through controlled regional separation.

Inventive Principle:
Principle #5Merging (Combining)

Solution Approach 2:

The single enclosure with flexible membranes serves multiple functions: it contains samples, reagents, amplification reactions, and detection components all in one device. This multi-functionality reduces the need for specialized equipment for each assay step, lowering overall costs while maintaining detection precision.

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

4Reliability

If current NAT assay procedures are used, then detection reliability is improved, but ease of operation decreases

Engineering Contradiction:
Improvedetection reliabilityVSAvoidoperational simplicity
Core Design Contradiction:
ReliabilityVSEase of operation

Solution Approach 1:

The device pre-segments the enclosure into functional regions that guide the operator through the assay process in a logical sequence. Each sealed region corresponds to a specific assay step, making the procedure more intuitive and easier to operate while maintaining reliable detection through controlled separation of steps.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The flexible membranes and sealed regions are designed to automatically maintain separation between assay steps without requiring complex manual intervention. The structure itself enforces proper procedure sequencing, reducing the skill level required for operation while ensuring reliable detection through consistent physical barriers.

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 solution enables efficient, automated, and contamination-controlled nucleic acid processing in resource-limited settings, simplifying the device structure and reducing contamination risks, making it suitable for field-testing and near-patient use.

Implementation Method 1

a blister defined between first and second walls wherein the first wall is flexible such that the blister can be divided into one or more sealed regions by an external pressure applied to a portion of the first wall that urges the first wall towards the second wall

Methodology Applied
Scientific EffectElastic deformation: Elasticity

Data Source

PatentUS10661271B2Device, system and method for processing a sample
Publication Date: 2020.05.26 DIAGNOSTICS FOR THE REAL WORLD LTD
  • US10661271B2 patent drawing
  • US10661271B2 patent drawing
  • US10661271B2 patent drawing

AI summary

A device for processing a sample comprises a blister defined by first and second walls. The first wall is flexible allowing the blister to be divided into one or more sealed regions by an external pressure applied to a portion of the first wall. The external pressure is applied in the form of a 2-dimensional shape to form a sealed region having that shape.