Elastic Medical Device Coating for Controlled Drug Release

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Solution Overview

Problem

Existing drug delivery systems for implantable medical devices face challenges in controlled release of bioactive agents, especially on elastic surfaces, where traditional polymer coatings are not suitable and may not provide sufficient therapeutic doses to target tissues during transient insertion.

Innovation Solution

The use of expandable elastic medical devices with a coating comprising a flexible hydrogel matrix and microparticulates, which become disassociated and released upon expansion, ensuring targeted bioactive agent delivery to tissues with controlled release components like biodegradable polymers.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If traditional polymer coatings are used on implantable devices, then drug release can be controlled, but the coatings are not suitable for elastic surfaces and may not provide sufficient therapeutic doses during transient insertion

Engineering Contradiction:
Improvedrug release controlVSAvoidsuitability for elastic surfaces
Core Design Contradiction:
ReliabilityVSAdaptability or versatility

Solution Approach 1:

The patent changes the physical and chemical parameters of the coating material by using a two-layer system: a rigid polymer coating for controlled drug release and a flexible hydrogel layer for adhesion to elastic surfaces. This parameter change allows the coating to maintain both drug release control and adaptability to expanding/contracting surfaces.

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The patent employs a composite coating structure consisting of a rigid polymer layer containing therapeutic compounds and a flexible hydrogel layer. This composite material combines the advantages of both materials: the rigid polymer provides controlled drug release while the flexible hydrogel ensures proper adhesion to elastic surfaces during device expansion and contraction.

Inventive Principle:
Principle #40Composite materials

2Ease of manufacture

If drugs are applied directly to the device surface, then the device can be manufactured simply, but the drug can be easily removed during insertion and release is difficult to control

Engineering Contradiction:
Improvedrug application simplicityVSAvoiddrug release control
Core Design Contradiction:
Ease of manufactureVSReliability

Solution Approach 1:

The patent applies the preliminary action principle by first forming the polymer coating with embedded therapeutic compounds on the device surface, then adding the flexible hydrogel layer. This sequential preparation ensures that the drug is securely entrapped in the polymer matrix before the device is inserted, preventing drug loss during insertion while maintaining controlled release capabilities.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The composite coating structure with the rigid polymer layer containing entrapped therapeutic compounds provides both secure drug retention during insertion and controlled release after implantation, while the flexible hydrogel layer ensures proper adhesion to the elastic surface.

Inventive Principle:
Principle #40Composite materials

3Productivity

If the device is expanded at the target site, then microparticulates can be released effectively, but bioactive agent loss may occur during insertion before expansion

Engineering Contradiction:
Improvemicroparticulate release effectivenessVSAvoidbioactive agent loss during insertion
Core Design Contradiction:
ProductivityVSLoss of substance

Solution Approach 1:

The patent uses preliminary action by securing the microparticulates in the flexible hydrogel layer before device insertion. The flexible hydrogel acts as a retaining matrix during transit, preventing premature release and bioactive agent loss, while allowing effective release upon expansion at the target site when the mechanical constraints are relieved.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The flexible hydrogel layer serves as a cushioning matrix that protects and retains the microparticulates during device insertion and handling. This beforehand cushioning prevents premature release and ensures that the microparticulates are delivered intact to the target site for effective release upon expansion.

Inventive Principle:
Principle #11Beforehand cushioning (Prior cushioning)

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

This approach minimizes bioactive agent loss during insertion, maximizes transfer to the target site, and provides sustained therapeutic effects by facilitating the controlled release of bioactive agents at the target tissue, enhancing the efficacy of drug delivery.

Implementation Method 1

an expandable elastic portion, a coating comprising a flexible hydrogel matrix on the expandable elastic portion... Upon expansion of the elastic portion in the subject, a portion of the microparticulates become disassociated from the coating

Methodology Applied
Scientific EffectElastic expansion: Elasticity

Implementation Method 2

The microparticulates comprise a bioactive agent that can be released following insertion of the device and transfer of the microparticulates to the tissue... provides sustained therapeutic effects by facilitating the controlled release of bioactive agents at the target tissue

Methodology Applied
Scientific EffectControlled release: Diffusion

Data Source

PatentUS11020513B2Insertable medical devices having microparticulate-associated elastic substrates and methods for drug delivery
Publication Date: 2021.06.01 SURMODICS INC
  • US11020513B2 patent drawing
  • US11020513B2 patent drawing
  • US11020513B2 patent drawing

AI summary

The present invention provides insertable medical devices having elastic surfaces associated with bioactive agent-containing microparticulates and a coating material. Upon expansion of the elastic surfaces the microparticulates can be released to a subject.