Microneedle Bioassay for Real-Time Interstitial Fluid Monitoring

Resolve Bottlenecks,
Find Innovative Solutions
Generate Solutions

Solution Overview

Problem

Conventional monitoring methods are invasive, require large sample volumes, and cause pain due to interactions with deeper skin layers, limiting their use for long-term sensing and drug delivery applications, while current microneedle technologies are not capable of performing long-term sensing or providing drug-injection feedback loops.

Innovation Solution

A microfluidic bioassay device integrated with microneedles and multifunctional lab-on-chip electrode arrays that can extract interstitial fluid for real-time monitoring, featuring a sensor component for marker detection, a delivery component for therapeutic agents, and an electronic component for signal processing and control, enabling minimally invasive, long-term diagnostic and treatment functions.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If conventional monitoring methods are used, then diagnostic accuracy is achieved, but pain and tissue damage occur due to interaction with deeper skin layers

Engineering Contradiction:
Improvediagnostic accuracyVSAvoidpain and tissue damage
Core Design Contradiction:
Measurement precisionVSObject-affected harmful factors

Solution Approach 1:

The device segments the monitoring function into two distinct needle types: hollow needles for fluid extraction and solid needles for drug delivery. This segmentation allows each needle type to be optimized for its specific function while minimizing overall invasiveness and pain compared to traditional single-needle approaches that must perform multiple functions.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The device applies local quality by using hollow needles specifically at sensing locations for interstitial fluid extraction, while solid needles are positioned at drug delivery locations. This localized differentiation allows minimally invasive fluid sampling without requiring deep penetration into pain-sensitive layers, thereby maintaining diagnostic accuracy while reducing pain and tissue damage.

Inventive Principle:
Principle #3Local quality

2Object-affected harmful factors

If microneedles are used for minimally invasive access, then pain and tissue damage are reduced, but long-term sensing capability is lost

Engineering Contradiction:
Improvepain and tissue damageVSAvoidlong-term sensing capability
Core Design Contradiction:
Object-affected harmful factorsVSDuration of action of moving object

Solution Approach 1:

The hollow microneedles enable continuous interstitial fluid extraction over extended periods, allowing long-term sensing capability. The fluid extraction pathway remains open and functional throughout the wear period, maintaining continuous monitoring capability without requiring repeated insertions or causing cumulative tissue damage that would limit duration.

Inventive Principle:
Principle #20Continuity of useful action

Solution Approach 2:

The device integrates multiple functions into a single wearable platform: hollow needles for long-term fluid extraction and sensing, solid needles for drug delivery, and integrated electronic components for real-time analysis. This multi-functionality allows the device to provide both minimally invasive access and sustained long-term sensing capability simultaneously.

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

3Object-affected harmful factors

If microneedles are used for fluid extraction, then minimally invasive access is achieved, but drug delivery feedback loop capability is lost

Engineering Contradiction:
Improveminimally invasive accessVSAvoiddrug delivery feedback loop capability
Core Design Contradiction:
Object-affected harmful factorsVSAdaptability or versatility

Solution Approach 1:

The device merges fluid extraction and drug delivery functions into a single integrated wearable platform. Hollow needles extract interstitial fluid for sensing while solid needles deliver therapeutic agents, with electronic components providing real-time analysis and feedback control. This merging enables a complete drug-delivery feedback loop while maintaining minimally invasive microneedle access.

Inventive Principle:
Principle #5Merging (Combining)

Solution Approach 2:

The integrated electronic components continuously analyze extracted interstitial fluid and provide real-time feedback on physiological markers. Based on this feedback, the system can automatically adjust and control drug delivery through the solid needles, creating a closed-loop feedback system that maintains minimally invasive microneedle access while enabling sophisticated drug delivery capabilities.

Inventive Principle:
Principle #23Feedback

4Quantity of substance

If larger needles are used to extract blood, then sample volume is increased, but pain and discomfort increase

Engineering Contradiction:
Improvesample volumeVSAvoidpain and discomfort
Core Design Contradiction:
Quantity of substanceVSObject-affected harmful factors

Solution Approach 1:

The device segments the sampling function by using hollow microneedles specifically for interstitial fluid extraction rather than blood drawing. This segmentation allows sufficient sample volume collection for diagnostic analysis while keeping needle size small enough to avoid deep tissue penetration and associated pain and discomfort.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The hollow microneedles are positioned and designed to access interstitial fluid locally in the epidermis or upper dermis, avoiding deeper pain-sensitive layers. This localized fluid extraction provides adequate sample volume for sensing applications while maintaining minimally invasive characteristics and reducing pain and discomfort compared to larger blood-drawing needles.

Inventive Principle:
Principle #3Local quality

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 minimally invasive, real-time monitoring and treatment platform capable of detecting physiological markers and delivering therapeutic agents, reducing pain and tissue damage, and enabling autonomous diagnostic and treatment functions.

Implementation Method 1

at least one sensing transducer is configured to detect one or more markers in the sample

Methodology Applied
Scientific EffectElectrochemical detection: Electrochemiluminescence

Implementation Method 2

Their size enables minimally-invasive interrogation due to their ability to puncture the skin's stratum corneum and access interstitial fluid

Methodology Applied
Scientific EffectCapillary action: Capillary Action

Data Source

PatentUS9987427B1Diagnostic/drug delivery “sense-respond” devices, systems, and uses thereof
Publication Date: 2018.06.05 NATIONAL TECHNOLOGY & ENGINEERING SOLUTIONS OF SANDIA LLC
  • US9987427B1 patent drawing
  • US9987427B1 patent drawing
  • US9987427B1 patent drawing

AI summary

The present invention is directed to devices, systems, and methods for detecting and/or monitoring one or more markers in a sample. In particular, such devices integrate a plurality of hollow needles configured to extract or obtain a fluid sample from a subject, as well as transducers to detect a marker of interest.