Wearable Patch With Hollow Microneedles for Non-Invasive Biomarker Prediction

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Solution Overview

Problem

Current methods for diagnosing cardiovascular complications, such as heart diseases, are often unreliable and invasive, with biomarkers in blood being insufficient for detecting conditions originating in solid tissues, and existing monitoring systems fail to predict upcoming conditions effectively.

Innovation Solution

A wearable patch system equipped with hollow microneedles, an assay compartment, and a microprocessor that collects and analyzes biological fluid for biomarkers, using an osmotic gradient or pumping mechanism to draw fluid and communicate data to a computing device for predictive analysis via a neural network.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If blood tests are used to detect biomarkers for cardiovascular complications, then diagnostic capability is provided, but the method is invasive and time-consuming

Engineering Contradiction:
Improvediagnostic capabilityVSAvoidinvasiveness
Core Design Contradiction:
ReliabilityVSEase of operation

Solution Approach 1:

The patent extracts the diagnostic function from invasive blood tests by using microneedles to access interstitial fluid in the skin, providing a non-invasive alternative that maintains biomarker detection capability while eliminating the need for venipuncture and blood processing

Inventive Principle:
Principle #2Taking out (Extraction)

Solution Approach 2:

The patent introduces interstitial fluid as an intermediary medium between the body's cardiovascular system and the diagnostic assay. By detecting biomarkers in interstitial fluid rather than requiring direct blood sampling, the system provides a non-invasive window into cardiovascular health status

Inventive Principle:
Principle #24Intermediary (Mediator)

2Measurement precision

If tissue biopsies are used to detect biomarkers for solid tissue conditions, then detection accuracy is improved, but the process becomes time-consuming, painful, risky, and costly

Engineering Contradiction:
Improvedetection accuracyVSAvoidprocedure complexity
Core Design Contradiction:
Measurement precisionVSEase of operation

Solution Approach 1:

The patent extracts the diagnostic function from invasive tissue biopsies by accessing biomarkers through the skin's interstitial fluid using microneedles, eliminating the need for surgical tissue removal while maintaining the ability to detect solid tissue conditions

Inventive Principle:
Principle #2Taking out (Extraction)

Solution Approach 2:

The patent changes the sampling parameter from solid tissue biopsy to liquid interstitial fluid collection. This parameter change transforms the invasive surgical procedure into a simple skin penetration process, reducing pain, risk, and complexity while maintaining detection capability

Inventive Principle:
Principle #35Parameter changes

3Reliability

If continuous monitoring is implemented to predict upcoming conditions, then predictive capability is improved, but device complexity and data processing requirements increase

Engineering Contradiction:
Improvepredictive capabilityVSAvoidmonitoring system complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The patent segments the monitoring system into modular functional components: microneedle array for fluid collection, portable assay device for biomarker detection, and separate data processing system for predictive analysis. This segmentation reduces overall system complexity by allowing each component to be optimized independently

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The patent implements self-service through automated microneedle fluid collection and on-device assay processing. The system automatically collects interstitial fluid, processes it for biomarker detection, and transmits data without requiring manual intervention, reducing operational complexity while enabling continuous monitoring

Inventive Principle:
Principle #25Self-service

4Adaptability or versatility

If multiple biomarkers are tested simultaneously in a multiplex reaction, then diagnostic comprehensive is improved, but assay complexity and processing time increase

Engineering Contradiction:
Improvediagnostic comprehensiveVSAvoidassay complexity
Core Design Contradiction:
Adaptability or versatilityVSDevice complexity

Solution Approach 1:

The patent merges multiple biomarker detection assays into a single multiplex reaction platform. By combining several detection channels and biomarker targets into one integrated system, the patent achieves comprehensive diagnostic capability while managing complexity through unified assay architecture

Inventive Principle:
Principle #5Merging (Combining)

Solution Approach 2:

The patent creates a universal assay platform that can simultaneously detect multiple different biomarkers using the same microneedle collection system and integrated detection apparatus. This multi-functional system handles various diagnostic requirements through a single versatile platform rather than requiring separate specialized tests

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 system provides continuous, non-invasive monitoring and prediction of cardiovascular complications and other conditions by accurately detecting biomarkers, enabling timely interventions and personalized treatment regimens.

Implementation Method 1

The at least one hollow microneedle draws fluid from the subject to monitor the presence of at least one biomarker by way of at least one of an osmotic gradient and a pumping mechanism

Methodology Applied
Scientific EffectOsmotic gradient: Osmosis

Data Source

PatentUS20240203596A1Systems and methods for predicting a condition
Publication Date: 2024.06.20 LINDSAY LIFESCIENCE LLC
  • US20240203596A1 patent drawing
  • US20240203596A1 patent drawing
  • US20240203596A1 patent drawing

AI summary

A system and method for predicting a condition is described herein. A patch that affixes to a subject communicates with a computing device to allow one to predict a condition before it happens, during the occurrence of the condition, or after the occurrence of the condition.