Microneedle Array Active Agent Delivery Confirmation via Optical Response

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Solution Overview

Problem

It is difficult to confirm visually whether a microneedle array has delivered an active agent into the skin, as the small size and dried coating make it impossible to distinguish between coated and uncoated arrays without aid.

Innovation Solution

A method using a selected incident light spectrum to probe the microneedle array before and after application, detecting optical responses to determine if the active agent has been delivered, with a measurement device analyzing the difference in responses to indicate successful delivery.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Productivity

If microneedles are made small for effective skin penetration, then delivery effectiveness is improved, but visual detectability of active agent coating deteriorates

Engineering Contradiction:
Improvedelivery effectivenessVSAvoidvisual detectability
Core Design Contradiction:
ProductivityVSDifficulty of detecting and measuring

Solution Approach 1:

The patent applies fluorescent or phosphorescent materials to the microneedle array or active agent coating, causing them to emit light when excited by specific wavelengths. This creates a visible optical signal that allows detection and confirmation of the microneedle array and its coating, resolving the contradiction between small size and visual detectability.

Inventive Principle:
Principle #32Color changes

2Loss of substance

If the active agent coating is made thin to minimize material usage, then material efficiency is improved, but detectability of coating presence deteriorates

Engineering Contradiction:
Improvematerial efficiencyVSAvoidcoating detectability
Core Design Contradiction:
Loss of substanceVSDifficulty of detecting and measuring

Solution Approach 1:

By incorporating fluorescent or phosphorescent properties into the thin active agent coating or the microneedle structure, the patent enables detection of the coating's presence and distribution even when the coating is extremely thin, thus maintaining material efficiency while improving detectability.

Inventive Principle:
Principle #32Color changes

Solution Approach 2:

The patent replaces visual inspection methods with optical detection using fluorescence or phosphorescence excitation. This substitution allows detection of the thin coating through optical signals rather than relying on visual appearance, enabling detection of material-efficient thin coatings.

Inventive Principle:
Principle #28Mechanics substitution (Replace mechanical system)

3Loss of information

If optical detection methods are added to confirm active agent delivery, then delivery confirmation capability is improved, but device complexity increases

Engineering Contradiction:
Improvedelivery confirmation capabilityVSAvoiddetection system complexity
Core Design Contradiction:
Loss of informationVSDevice complexity

Solution Approach 1:

The microneedle array itself is made fluorescent or phosphorescent, allowing it to serve as both the delivery vehicle and the detection signal source. This self-service approach enables delivery confirmation without requiring separate complex detection equipment, as the array provides its own optical signal.

Inventive Principle:
Principle #25Self-service

Solution Approach 2:

The use of fluorescent or phosphorescent materials that can be excited by simple light sources provides a straightforward optical detection method. This approach improves delivery confirmation capability while minimizing the increase in device complexity, as the detection relies on inherent optical properties rather than complex measurement systems.

Inventive Principle:
Principle #32Color changes

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 confirmation of active agent delivery by measuring the change in optical responses, ensuring the desired amount of the agent has been transferred into the skin.

Implementation Method 1

An active agent formulation covers at least a portion of the tip of one or more of the microneedles and modulates the first optical response of the microneedles when probed with the selected incident light spectrum

Methodology Applied
Scientific EffectOptical response modulation: Absorption (EM radiation)

Implementation Method 2

a plurality of tapered microneedles arranged on a substrate, wherein the microneedles have a fluorescence that is greater than that of the substrate

Methodology Applied
Scientific EffectFluorescence: Fluorescence

Data Source

PatentUS8554317B2Microneedle arrays and methods of use thereof
Publication Date: 2013.10.08 KINDEVA DRUG DELIVERY LP
  • US8554317B2 patent drawing
  • US8554317B2 patent drawing
  • US8554317B2 patent drawing

AI summary

A method of treating a patient with a microneedle array having an active agent disposed on at least a portion of one or more of the microneedles, wherein the array with active agent is characterized by a first optical response when probed with a selected incident light spectrum. The array with active agent is applied to a skin surface, optionally allowed to remain on the skin surface for a specified time, and removed. The used array is probed with the selected incident light spectrum, a second optical response is sensed, and the difference between the first optical response and the second optical response is determined and compared to a predetermined threshold value.