Temperature-Responsive Coating for Drug-Coated Balloon Catheters

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Solution Overview

Problem

Inflatable balloon catheters face challenges with drug retention and uniform drug distribution due to substantial drug loss during tracking, leading to higher doses and systemic exposure, while current drug-coated balloons struggle to efficiently release therapeutic agents at the treatment site.

Innovation Solution

A temperature-responsive coating on the inflatable balloon catheter, with a release transition temperature between 30°C and 35°C, retains therapeutic agents at lower temperatures and releases them effectively when heated, allowing for reduced drug amounts and controlled delivery.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If a higher dose of therapeutic agent is coated on the inflatable balloon to compensate for drug loss during tracking, then the drug retention at the treatment site is improved, but the systemic drug exposure increases

Engineering Contradiction:

Improvedrug retention at treatment siteVSAvoidsystemic drug exposure

Core Design Contradiction:

ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The coating's temperature-sensitive properties are utilized to change its state from retaining at room temperature to releasing at body temperature, enabling controlled drug delivery that reduces systemic exposure while ensuring adequate treatment dose delivery

Inventive Principle:

Principle #35Parameter changes

Solution Approach 2:

The coating undergoes a phase transition at body temperature, changing from a drug-retaining state during tracking to a drug-releasing state at the treatment site, thereby improving drug retention effectiveness while minimizing systemic exposure

Inventive Principle:

Principle #36Phase transitions

2Reliability

If more therapeutic agent is coated on the inflatable balloon to ensure sufficient treatment, then the treatment efficacy is improved, but the uniformity of drug distribution across the atherosclerotic lesion deteriorates

Engineering Contradiction:

Improvetreatment efficacyVSAvoiduniformity of drug distribution

Core Design Contradiction:

ReliabilityVSManufacturing precision

Solution Approach 1:

The coating's temperature-sensitive characteristics enable it to maintain drug retention during tracking and then uniformly release the drug at body temperature, achieving both adequate treatment dose and uniform distribution across the lesion

Inventive Principle:

Principle #35Parameter changes

Solution Approach 2:

The phase transition of the coating at body temperature ensures simultaneous and uniform drug release across the entire coated surface, improving drug distribution uniformity while maintaining treatment efficacy

Inventive Principle:

Principle #36Phase transitions

3Reliability

If a higher dose of therapeutic agent is used to compensate for tracking loss, then the drug retention at the treatment site is improved, but the amount of therapeutic agent required increases

Engineering Contradiction:

Improvedrug retention at treatment siteVSAvoidamount of therapeutic agent

Core Design Contradiction:

ReliabilityVSQuantity of substance

Solution Approach 1:

The coating's phase transition at body temperature ensures that the therapeutic agent is retained during tracking and then efficiently released at the treatment site, reducing the total amount of drug needed while maintaining adequate retention

Inventive Principle:

Principle #36Phase transitions

Solution Approach 2:

By utilizing the coating's temperature-sensitive properties, the system achieves controlled drug release that improves retention efficiency, thereby reducing the overall quantity of therapeutic agent required for effective treatment

Inventive Principle:

Principle #35Parameter 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

The temperature-responsive coating enables efficient retention and controlled release of therapeutic agents, reducing systemic exposure and ensuring more uniform drug distribution across atherosclerotic lesions, thereby enhancing treatment efficacy while minimizing tissue exposure.

Implementation Method 1

When the temperature of the coating is below the release transition temperature, the coating retains at least a portion of the therapeutic agent on the exterior surface of the inflatable balloon

Methodology Applied

Scientific EffectThermal retention:

Implementation Method 2

When the temperature of the coating is above the release transition temperature, the coating releases at least a portion of the therapeutic agent from the exterior surface of the inflatable balloon

Methodology Applied

Scientific EffectThermal release:

Implementation Method 3

The coating has a release transition temperature within a range from about 30°C to about 35°C

Methodology Applied

Scientific EffectPhase transition: Phase Change

Data Source

PatentEP3238773B1Drug coated inflatable balloon having a thermal dependent release layer

Publication Date: 2023.11.22 MEDTRONIC VASCULAR INC

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Figure 3~4
Figure 5A~5B

AI summary

A medical device includes an inflatable balloon defining an interior surface and an exterior surface, and a coating including a therapeutic agent disposed on the exterior surface of the inflatable balloon. The coating has a release transition temperature within a range from about 25°C to about 50°C. When the temperature of the coating is below the release transition temperature, the coating retains at least a portion of the therapeutic agent on the exterior of the inflatable balloon. When the temperature of the coating is above the release transition temperature, the coating releases at least a portion of the therapeutic agent from the exterior of the inflatable balloon.