Microneedle Patch for Ultrasensitive ISF Biomarker Detection
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Solution Overview
Problem
Current methods for extracting and analyzing interstitial fluid (ISF) are invasive, time-consuming, and inefficient, with limited sensitivity, making comprehensive proteomic and metabolomic analysis challenging, especially for point-of-care and resource-limited settings.
Innovation Solution
A bilayered microneedle patch with a magnetic backing layer and an array of microneedles coated with capture biorecognition elements and ultrabright plasmonic-fluor labels for direct sampling and ultrasensitive detection of protein biomarkers in dermal interstitial fluid, enabling minimally invasive, quantitative, and sensitive analysis.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Productivity
If conventional ISF extraction methods are used, then sample collection is achieved, but the process is time-consuming and requires bulky instruments
Solution Approach 1:
The patent divides the ISF extraction system into microneedle units that can penetrate skin individually, allowing parallel sampling from multiple sites simultaneously. This segmentation enables rapid sample collection without requiring bulky centralized extraction equipment, directly improving productivity while reducing time loss.
Solution Approach 2:
The patent extracts the essential function of ISF collection from complex extraction machines and implements it through simple microneedle patches that can be applied directly to skin. This takes out the cumbersome instrumentation and replaces it with a minimalistic approach using microneedles alone for effective ISF sampling.
2Ease of operation
If microneedle-assisted extraction is used, then sample collection is simplified, but the sample volume is extremely small (only 3-5 μL)
Solution Approach 1:
The patent merges multiple microneedle sampling sites into a single patch device, allowing simultaneous collection from numerous skin locations. This combining approach accumulates sufficient sample volume for comprehensive proteomic and metabolomic analysis while maintaining the operational simplicity of microneedle application.
Solution Approach 2:
The patent transitions from single-point ISF extraction to multi-point parallel extraction across the skin surface. By utilizing the two-dimensional array of microneedles in the patch, the system dramatically increases total sample volume while keeping each individual needle simple and easy to apply.
3Productivity
If vacuum suction is used for ISF withdrawal, then sample collection is achieved, but strong suction may alter analyte concentration
Solution Approach 1:
The microneedle patch performs self-driven ISF collection through passive diffusion and capillary action along the needle shafts, eliminating the need for external vacuum suction. This self-service mechanism naturally maintains physiological analyte concentrations without the distortion caused by strong suction forces.
4Ease of manufacture
If conventional detection methods are used, then analysis is performed, but sensitivity is limited making ultrasensitive detection challenging
Solution Approach 1:
The patent changes the detection parameter from conventional fluorophores to ultrabright plasmonic-fluor labels, which provide dramatically enhanced fluorescence signals. This parameter change in the detection reagent enables ultrasensitive detection of protein biomarkers while maintaining ease of implementation through standard immunoassay procedures.
Solution Approach 2:
The patent employs composite plasmonic-fluor labels that combine metallic nanorods with fluorescent dyes, creating materials with both plasmonic resonance and fluorescence properties. This composite structure amplifies the detection signal through plasmonic enhancement, achieving ultrasensitivity while keeping the detection method manufacturable and practical.
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 microneedle patch allows for rapid, sensitive, and quantitative detection of protein biomarkers, improving the limit-of-detection by nearly 800-fold compared to conventional methods, facilitating efficient and minimally invasive sampling and analysis of ISF, suitable for both clinical and pre-clinical applications.
Implementation Method 1
the microneedle layer comprises an array of microneedles coated with a plurality of capture biorecognition elements
Implementation Method 2
adding a plurality of fluorescent labels to the microneedle patch, wherein each of the plurality of fluorescent labels comprises a plasmonic-fluor; and detecting the target ISF analyte based on a fluorescence signal from the plasmonic-fluor
Data Source
AI summary
The present disclosure is directed to microneedle patches for direct sampling and ultrasensitive detection of protein biomarkers in dermal interstitial fluids. The microneedle patches are comprised of polymers with high protein absorption capability (e.g. polystyrene) and are modified with capture biorecognition elements that are specific to target analytes in the interstitial fluid (ISF). Systems and methods are further provided for detection of a target ISF analyte obtained by in vivo sampling of the ISF using a microneedle patch.