Drug Coated Balloon Adhesion Additive for Vessel Wall Transfer

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Solution Overview

Problem

Drug-coated balloons face challenges in delivering therapeutic agents effectively due to the short contact time between the drug-coated balloon surface and the blood vessel wall, leading to inadequate drug transfer and increased risk of restenosis after angioplasty.

Innovation Solution

A system comprising an expandable member coated with a therapeutic formulation that includes a therapeutic agent and an adhesion additive, such as polycationic or polyanionic polymers, to promote adhesion and uptake of the therapeutic agent into the vessel wall, enhancing drug delivery and retention.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Loss of time

If a drug-coated balloon is used for short-duration inflation, then the procedure time is reduced and vessel trauma is minimized, but the drug transfer efficiency to the vessel wall becomes insufficient

Engineering Contradiction:

Improveinflation timeVSAvoiddrug transfer efficiency

Core Design Contradiction:

Loss of timeVSReliability

Solution Approach 1:

The patent changes the physical and chemical parameters of the coating formulation by incorporating adhesion promoters (polycationic or polyanionic polymers) and adjusting solvent composition (DMSO, ethanol, water ratios). These parameter changes enable the coating to transfer effectively to the vessel wall within the short inflation time window, resolving the contradiction between quick procedure and adequate drug delivery.

Inventive Principle:

Principle #35Parameter changes

Solution Approach 2:

The patent uses composite coating formulations combining therapeutic agents with adhesion-promoting polymers (such as polyethyleneimine, chitosan, carboxymethyl cellulose, or hyaluronic acid). This composite approach enhances the coating's ability to adhere to the vessel wall during brief contact, maintaining drug transfer efficiency despite reduced inflation time.

Inventive Principle:

Principle #40Composite materials

2Productivity

If the balloon contacts the vessel wall for a short period, then procedural efficiency is improved, but the residence time of the therapeutic agent on the vessel wall is insufficient

Engineering Contradiction:

Improveprocedural efficiencyVSAvoidresidence time

Core Design Contradiction:

ProductivityVSDuration of action of moving object

Solution Approach 1:

The patent introduces adhesion promoter polymers as intermediary substances between the drug coating and the vessel wall. These polymers act as mediators that extend the effective residence time of the therapeutic agent on the vessel wall by creating stronger adhesive bonds, allowing sufficient drug transfer even during brief balloon inflation periods.

Inventive Principle:

Principle #24Intermediary (Mediator)

Solution Approach 2:

The coating formulation is pre-engineered with adhesion promoters and optimized solvent systems before application. This preliminary preparation ensures that upon contact with the vessel wall, the coating rapidly adheres and transfers the therapeutic agent, maximizing residence time within the limited inflation window.

Inventive Principle:

Principle #10Preliminary action

3Device complexity

If traditional drug coatings are used without adhesion additives, then the formulation is simpler, but the adhesion and retention of the therapeutic agent on the vessel wall is poor

Engineering Contradiction:

Improveformulation complexityVSAvoidadhesion and retention

Core Design Contradiction:

Device complexityVSReliability

Solution Approach 1:

The patent develops composite coating formulations that integrate therapeutic agents with biocompatible adhesion-promoting polymers. Examples include combinations of paclitaxel with carboxymethyl cellulose, or zotarolimus with hyaluronic acid. These composites enhance adhesion and retention while maintaining relative formulation simplicity and biocompatibility.

Inventive Principle:

Principle #40Composite materials

Solution Approach 2:

The patent modifies the chemical composition parameters of the coating by incorporating specific polymers (polycationic or polyanionic) and optimizing solvent ratios (DMSO, ethanol, water). These parameter changes significantly improve adhesion and retention properties without substantially complicating the manufacturing process.

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 use of adhesion additives increases the residence time and transfer efficiency of therapeutic agents to the vessel wall, reducing restenosis rates and improving treatment outcomes compared to traditional drug-coated balloons and stents.

Implementation Method 1

an adhesion additive to promote adhesion of the therapeutic formulation to the vessel wall

Methodology Applied

Scientific EffectAdhesion: Adhesive

Implementation Method 2

promote adhesion and uptake of the therapeutic agent into the vessel wall

Methodology Applied

Scientific EffectAbsorption: Absorption (physical)

Data Source

PatentUS9782516B2Tissue adhesive coatings for drug coated balloon

Publication Date: 2017.10.10 ABBOTT CARDIOVASCULAR SYSTEMS INC

AI summary

A therapeutic formulation is described for a drug delivery balloon comprising a therapeutic formulation which includes a therapeutic agent and an adhesion additive. The adhesion additive promotes adhesion of the therapeutic formulation a vessel wall of a subject. A system and a method of manufacturing a system including an expandable member having a working length with the therapeutic formulation disposed along at least a portion of the working length is also provided.