Microneedle Devices with Eutectic Anesthetic Coating

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Solution Overview

Problem

Current methods for transdermal delivery of local anesthetics, such as through microneedle devices, face challenges in achieving predictable and controlled delivery across the stratum corneum, with existing solutions often resulting in non-uniform penetration and limited duration of anesthetic effect.

Innovation Solution

Microneedle devices coated with a combination of lidocaine and prilocaine, along with a local anesthetic dose-extending component like tetracaine, ropivacaine, or bupivacaine, provide a controlled, immediate, and sustained anesthetic effect by dissolving in tissue, ensuring higher and extended tissue levels compared to traditional methods.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Quantity of substance

If microneedles are used to penetrate the stratum corneum, then transdermal delivery is enhanced, but penetration uniformity deteriorates due to skin deflection and resistance

Engineering Contradiction:
Improveagent flux through stratum corneumVSAvoidpenetration uniformity
Core Design Contradiction:
Quantity of substanceVSManufacturing precision

Solution Approach 1:

The patent changes the physical state of the anesthetic from liquid to solid by forming a eutectic mixture, which allows the microneedles to maintain structural integrity during penetration while delivering a controlled amount of anesthetic, thereby improving penetration uniformity while maintaining enhanced agent flux

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The patent uses a composite eutectic mixture of lidocaine and prilocaine in specific proportions (2.5% lidocaine and 2.5% prilocaine) that creates a material with optimized properties for both penetration and controlled delivery, resolving the contradiction between enhanced flux and uniform penetration

Inventive Principle:
Principle #40Composite materials

2Object-affected harmful factors

If topical anesthesia cream is applied, then pain management is achieved, but application time must be extended to 60 minutes

Engineering Contradiction:
Improvepain or discomfortVSAvoidapplication time
Core Design Contradiction:
Object-affected harmful factorsVSLoss of time

Solution Approach 1:

The microneedles are pre-coated with the eutectic anesthetic mixture before application, so that the active ingredients are already in position to be delivered immediately upon penetration, eliminating the need for prolonged application time while maintaining effective pain management

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The patent replaces the passive diffusion mechanism of topical creams with active mechanical penetration via microneedles, enabling immediate delivery of the anesthetic without requiring extended contact time, thus reducing loss of time while achieving the same pain relief effect

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

3Device complexity

If a dried coating on microneedles is used, then device simplicity is improved, but controlled and sustained delivery is compromised

Engineering Contradiction:
Improvedevice simplicityVSAvoidanesthetic effect duration
Core Design Contradiction:
Device complexityVSDuration of action of moving object

Solution Approach 1:

The patent changes the physical and chemical parameters of the coating by creating a eutectic mixture with specific composition ratios, which controls the dissolution rate and maintains sustained anesthetic effect while keeping the device structure simple and coating-based

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The patent creates local quality variations in the coating by using a eutectic mixture that dissolves at a controlled rate in the tissue, providing sustained delivery of anesthetic while maintaining overall device simplicity, thus resolving the contradiction between simple structure and controlled sustained delivery

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 microneedle devices achieve higher and sustained tissue levels of local anesthetics, offering improved pain management for procedures like venepuncture and dermatological procedures, with a controlled dose that minimizes toxicity risks.

Implementation Method 1

After penetrating the stratum corneum, the local anesthetic in the coating on the microneedles dissolves in the tissue underlying the stratum corneum. In the case of dissolvable microneedles, the local anesthetic in the microneedles dissolves in the tissue.

Methodology Applied
Scientific EffectDissolution: Solvation

Implementation Method 2

using topical anesthesia, such as EMLATM cream, a eutectic mixture of 2.5% lidocaine and 2.5% prilocaine

Methodology Applied
Scientific EffectEutectic mixture: Phase Change

Implementation Method 3

Passive delivery of this type involves the agent diffusing across at least the stratum corneum, where the rate of diffusion through the stratum corneum can be rate limiting.

Methodology Applied
Scientific EffectDiffusion: Diffusion

Data Source

PatentEP2683359B1Microneedle devices and methods
Publication Date: 2015.04.22 3M INNOVATIVE PROPERTIES CO
  • EP2683359B1 patent drawingFigure 1~2
  • EP2683359B1 patent drawingFigure 3~4
  • EP2683359B1 patent drawingFigure 5~7

AI summary

A medical device, comprising: an array of microneedles, and a coating disposed on the microneedles, wherein the coating comprises: a local anesthetic selected from the group consisting of lidocaine, prilocaine, and a combination thereof; and a local anesthetic dose-extending component selected from the group consisting of tetracaine, ropivacaine, bupivacaine, procaine and a combination thereof; wherein the local anesthetic is present in an amount of at least 1 wt-% based upon total weight of solids in the coating, and wherein the local anesthetic and dose-extending component are in a non-eutectic weight ratio; a medical device, comprising an array of dissolvable microneedles, the microneedles comprising: a dissolvable matrix material; at least 1 wt-% of a local anesthetic selected from the group consisting of lidocaine, prilocaine, and a combination thereof; and a local anesthetic dose-extending component selected from the group consisting of tetracaine, ropivacaine, bupivacaine, procaine and a combination thereof; wherein the local anesthetic and dose-extending component are in a non-eutectic weight ratio, and wherein wt-% is based upon total weight of solids in all portions of the dissolvable microneedles which contain the local anesthetic; a method of extending a topically delivered local anesthetic dose in mammalian tissue using the devices; and methods of making the devices are provided.