NEEDLE-BASED DEVICES AND METHODS FOR IN VIVO DIAGNOSTICS OF DISEASE CONDITIONS

Smart overview of the Invention

Innovative diagnostic devices and methods are designed for in vivo screening of disease conditions, particularly cancer and Mendelian diseases. These devices facilitate direct contact with cell-free nucleic acids or circulating tumor cells (CTCs) in a patient’s bloodstream, utilizing a needle equipped with a specialized detection reaction module.

Importance of Cell-Free Nucleic Acids

The study of cell-free DNA (cfDNA) in body fluids like plasma and urine has gained traction due to its potential as a non-invasive biomarker for cancer detection. The presence of specific genetic alterations in cfDNA can indicate the early stages of cancer, making it a valuable tool for clinicians. As cancer cases continue to rise globally, effective screening methods are essential for improving patient outcomes.

Challenges in Current Detection Methods

Current diagnostic methods face limitations due to the small volume of blood sampled, which often leads to missed diagnoses. Detecting CTCs and cfDNA directly in the bloodstream could enhance early cancer detection and monitoring. The need for improved devices that can isolate and characterize these biomarkers in vivo is evident.

Device Structure and Functionality

The proposed diagnostic device includes a needle with nanostructures on its surface that can capture and analyze cell-free biological samples. These nanostructures may incorporate advanced components like Cas proteins and engineered CRISPR targeting RNAs, allowing for highly sensitive detection of various genetic mutations associated with cancer.

Screening Methodology

The method involves inserting the device into the bloodstream to collect samples, followed by analysis to identify signals indicative of disease conditions. The device's design enables efficient sampling and high sensitivity, with potential applications in real-time monitoring and early diagnosis of cancers through minimal invasiveness.