Isothermal Nucleic Acid Amplification Incubator with Phase Change Material

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Solution Overview

Problem

Existing point-of-care (POC) devices for isothermal nucleic acid amplification tests (NAATs) face challenges such as inconsistent energy output, toxicity of reactants, complexity, and expense due to reliance on microcontrollers and sophisticated equipment.

Innovation Solution

A portable, inexpensive POC device that maintains isothermal conditions using a heater, heat sinks, and phase change material (PCM) to incubate NAATs, eliminating the need for complex electronics and expensive equipment.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of manufacture

If exothermic chemical reactions are used as heat source, then device cost is reduced and robustness is improved, but energy output consistency deteriorates and user expertise requirement increases

Engineering Contradiction:
Improvedevice costVSAvoidenergy output consistency
Core Design Contradiction:
Ease of manufactureVSReliability

Solution Approach 1:

The patent replaces the chemical heating system (exothermic reactions) with an electrical heating system (resistive heating element). This substitution eliminates the inconsistencies associated with chemical reactant performance while maintaining low device cost through the use of simple, reliable electrical components that can be precisely controlled.

Inventive Principle:
Principle #28Mechanics substitution (Replace mechanical system)

Solution Approach 2:

The patent changes the heating mechanism from chemical to electrical, allowing for precise control of heating parameters through a microcontroller. This enables consistent energy output by electronically regulating the resistive heating element, overcoming the variability inherent in chemical reactions while keeping the device simple and affordable.

Inventive Principle:
Principle #35Parameter changes

2Measurement precision

If micro-controller is used to control heating, then temperature control precision is improved, but device complexity and expense increase

Engineering Contradiction:
Improvetemperature control precisionVSAvoiddevice complexity
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The patent implements a self-regulating temperature control system where the phase change material automatically maintains isothermal conditions during phase transition. The microcontroller simply monitors and makes minor adjustments, allowing the system to self-regulate temperature without complex control algorithms or additional active components, thus achieving precise temperature control with minimal added complexity.

Inventive Principle:
Principle #25Self-service

Solution Approach 2:

The patent utilizes phase change material (PCM) that undergoes phase transition at the target temperature, providing automatic thermal regulation. The PCM absorbs excess heat during melting and releases heat during solidification, creating a natural feedback mechanism that works with the microcontroller to maintain precise isothermal conditions without requiring complex control systems.

Inventive Principle:
Principle #36Phase transitions

3Use of energy by moving object

If reaction volume is placed in microchip, then surface area for heating is maximized, but ease of operation deteriorates

Engineering Contradiction:
Improveheating efficiencyVSAvoidease of operation
Core Design Contradiction:
Use of energy by moving objectVSEase of operation

Solution Approach 1:

The patent transitions from two-dimensional microchip reactions to three-dimensional reaction tubes that can be placed vertically in the heating device. This dimensional change allows for adequate surface area contact with the heating element while enabling easy insertion and removal of standard PCR tubes, significantly improving ease of operation without sacrificing heating efficiency.

Inventive Principle:
Principle #17Another dimension (Dimensionality change)

Solution Approach 2:

The patent uses standard PCR tubes as reaction vessels, which are universally compatible with existing molecular biology equipment and protocols. This universal approach allows the device to accept any standard PCR tube without custom adapters or specialized containers, greatly enhancing ease of operation while the resistive heating element maintains efficient thermal contact with the tube surfaces.

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 device provides a robust, user-friendly method for diagnosing infectious diseases in low-resource settings, ensuring timely and accurate treatment, and potentially slowing the spread of disease.

Implementation Method 1

A portable, inexpensive POC device that maintains isothermal conditions using a heater

Methodology Applied
Scientific EffectResistive heating: Joule Heating

Implementation Method 2

phase change material (PCM) adapted for regulating temperature of the reactions

Methodology Applied
Scientific EffectPhase change: Phase Change

Implementation Method 3

at least one heat sink disposed in the housing in thermal communications with heater, and configured to speed up heating

Methodology Applied
Scientific EffectThermal conduction: Conduction (thermal)

Data Source

PatentUS20250041869A1Point-of-care incubator for isothermal nucleic acid amplification tests (PIINT) and applications of same
Publication Date: 2025.02.06 THE BOARD OF TRUSTEES OF THE UNIV OF ARKANSAS
  • US20250041869A1 patent drawing
  • US20250041869A1 patent drawing
  • US20250041869A1 patent drawing

AI summary

This invention provides a point-of-care (POC) device for isothermal nucleic acid amplification tests (NAAT). The POC device comprises a housing; a heater disposed in the housing; at least one heat sink disposed in the housing in thermal communications with the heater, and configured to speed up heating and hold reaction tubes containing the NAAT being incubated; and a phase change material adapted for regulating temperature of the reactions. The POC device is a point-of-care incubator for isothermal nucleic acid amplification tests (PIINT). The POC device is used for POC detection of Johne's disease (JD) in a subject.