Lipid Coating for Medical Devices Enhancing Drug Release

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Solution Overview

Problem

Existing medical devices with static surfaces and polymer coatings are inadequate for delivering therapeutic agents to dynamic or elastic surfaces, as they often fail to provide sufficient drug release to target tissues, especially when the device is transiently inserted or has a non-static surface.

Innovation Solution

A medical device with an expandable and collapsible structure coated with a bioactive agent and a lipid coating that is solid at room temperature but melts at body temperature, facilitating controlled release and improved delivery of therapeutic agents to tissues.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If polymer coatings are used on static surfaces, then drug release is controlled, but the coating is not suitable for dynamic or elastic surfaces and does not provide sufficient drug release to target tissues

Engineering Contradiction:
Improvedrug release effectivenessVSAvoidsurface compatibility
Core Design Contradiction:
ReliabilityVSAdaptability or versatility

Solution Approach 1:

The patent applies parameter changes by using a lipid coating with a specific melting point range (37-45°C) that transitions from solid at room temperature to liquid at body temperature. This phase change parameter enables the coating to adapt to dynamic surfaces while maintaining drug delivery effectiveness, resolving the contradiction between reliability and adaptability.

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The invention uses a composite lipid coating system that combines multiple lipid components with specific melting points. This composite material approach creates a coating that is both adaptable to dynamic surfaces and effective at controlling drug release, simultaneously addressing both requirements.

Inventive Principle:
Principle #40Composite materials

2Reliability

If the lipid coating melts at body temperature, then drug release is enhanced at the target site, but the coating may be unstable during handling and storage at room temperature

Engineering Contradiction:
Improvedrug release effectivenessVSAvoidcoating stability
Core Design Contradiction:
ReliabilityVSStability of the object's composition

Solution Approach 1:

The patent carefully selects lipid components with melting points in the 37-45°C range, creating a narrow transition zone between solid and liquid states. This parameter optimization ensures the coating remains stable during handling (solid state) while effectively releasing drug at body temperature (liquid state), resolving the stability-release contradiction.

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The lipid coating acts as an intermediary medium that transitions between solid and liquid states based on temperature. This intermediary behavior allows the coating to maintain structural integrity during storage and handling while facilitating drug release at the target site, bridging the contradiction between stability and effectiveness.

Inventive Principle:
Principle #24Intermediary (Mediator)

3Productivity

If the device is transiently inserted, then minimal intervention is required, but the polymer coating does not provide sufficient drug release rate to target tissue

Engineering Contradiction:
Improvedrug release rateVSAvoiddevice insertion duration
Core Design Contradiction:
ProductivityVSDuration of action of moving object

Solution Approach 1:

The patent exploits phase transitions of the lipid coating, which melts from solid to liquid at body temperature (37-45°C). This phase change dramatically increases the drug release rate during the brief transient insertion period, enabling high productivity despite short duration of action. The phase transition occurs precisely when the device contacts target tissue, maximizing drug delivery efficiency.

Inventive Principle:
Principle #36Phase transitions

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 lipid coating enhances the delivery of bioactive agents by protecting the agent during handling, reducing friction, and ensuring effective release at the target site, increasing the amount of therapeutic agent delivered and maintaining structural integrity of the coating.

Implementation Method 1

a lipid coating on the agent coating, wherein the lipid coating is solid at room temperature and liquid at 37 °C

Methodology Applied
Scientific EffectMelting: Melting

Data Source

PatentEP2588157B1Lipid coating for medical devices delivering bioactive agent
Publication Date: 2020.03.18 SURMODICS INC
  • EP2588157B1 patent drawingFigure 1
  • EP2588157B1 patent drawingFigure 2
  • EP2588157B1 patent drawingFigure 3

AI summary

The present invention relates compositions for delivering therapeutic agents from a medical device including an expandable and collapsible structure and methods employing them. A lipid coating including one or more fatty acids increases the amount of therapeutic agent released from the device at the delivery site. The therapeutic agent can be in a matrix including a hydrophilic polymer or an amphiphilic polymer. Release and adhesion coatings can also facilitate delivery of therapeutic agent.