Intraoperative Nucleic Acid Analysis Device Using Isothermal Amplification
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Solution Overview
Problem
Current molecular diagnostics face challenges in translating genomic discoveries into clinical practice due to time constraints, manual labor requirements, and limited analysis capabilities, particularly in surgical settings where rapid nucleic acid analysis is needed for surgical specimens.
Innovation Solution
Development of integrated devices and methods for intraoperative analysis of nucleic acids from solid tumors using isothermal amplification and computational units to assess gene expression levels, enabling rapid and accurate diagnosis during surgical procedures.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If traditional molecular diagnostic methods are used for surgical specimens, then analysis accuracy can be maintained, but analysis time is too long and requires specialized facilities
Solution Approach 1:
The device segments the molecular diagnostic process into modular functional units: sample input unit, nucleic acid analysis unit with isothermal amplification, and computational unit. This segmentation enables the system to be performed in smaller, faster steps rather than as a monolithic process, reducing overall analysis time while maintaining accuracy
Solution Approach 2:
The patent employs isothermal amplification which changes the temperature parameter from traditional PCR's cyclic temperature changes to a constant temperature process. This parameter change eliminates the need for complex thermal cycling equipment and reduces amplification time, enabling rapid nucleic acid analysis in surgical settings
2Measurement precision
If complex multivariate analysis is performed manually, then comprehensive results can be obtained, but the process requires specially trained personnel and cannot be performed during surgery
Solution Approach 1:
The computational unit performs multivariate analysis automatically without requiring manual intervention or specialized training. The system self-services by taking raw nucleic acid data and automatically applying complex algorithms to generate clinically meaningful results, eliminating the need for specially trained personnel to perform calculations during surgery
Solution Approach 2:
The computational unit acts as an intermediary between the nucleic acid analysis unit and the surgeon. It translates complex molecular data into simplified clinical interpretations, mediating the information flow and making sophisticated analysis results accessible to clinicians without requiring them to understand the underlying complexity
3Measurement precision
If traditional facilities and resources are required for molecular analysis, then analysis quality can be maintained, but the locations where samples can be analyzed are limited
Solution Approach 1:
The integrated device combines multiple functions into a single portable system: sample reception, nucleic acid extraction, isothermal amplification, and computational analysis. This multi-functionality allows the same device to perform complete molecular diagnostics in diverse locations including operating rooms, clinics, and remote settings, greatly increasing location flexibility while maintaining analysis quality
Solution Approach 2:
The patent replaces complex mechanical and thermal systems with isothermal amplification that operates at constant temperature. This substitution eliminates the need for sophisticated thermal cycling equipment and specialized laboratory infrastructure, enabling high-quality molecular analysis in locations previously unsuitable for such procedures
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 real-time analysis of nucleic acid expression during surgeries, allowing for immediate decision-making and reducing the need for additional procedures, thereby improving patient outcomes and reducing medical costs.
Implementation Method 1
measuring the target nucleic acid expression level comprises an isothermal amplification of the target nucleic acid
Data Source
AI summary
Provided herein are devices and methods for rapid analysis of biological samples. In particular, devices and methods described herein can be applied to rapid nucleic acid analysis of solid tissue samples.