Gradient Paclitaxel Shellac Coating for Catheter Balloons

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Solution Overview

Problem

Current catheter balloon coatings with paclitaxel do not effectively prevent restenosis due to inadequate release of the active agent, as the existing methods do not achieve a controlled gradient distribution, leading to insufficient therapeutic effect.

Innovation Solution

A catheter balloon coating with a gradient distribution of paclitaxel in shellac, featuring both vertical and horizontal concentration gradients, ensuring effective transfer and release of the active agent to the vessel wall during balloon inflation.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If a uniform coating of paclitaxel in shellac is applied to the catheter balloon, then the coating structure is simple and manufacturing is easy, but the drug release is insufficient and therapeutic effect is inadequate

Engineering Contradiction:
Improvetherapeutic effectVSAvoidcoating structure
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The patent applies a gradient coating structure where the paclitaxel concentration varies spatially within the shellac matrix. The coating features a high concentration region near the balloon surface for immediate drug release and a low concentration region deeper in the matrix for sustained release, creating locally optimized drug delivery zones that enhance therapeutic effectiveness

Inventive Principle:
Principle #3Local quality

Solution Approach 2:

The patent changes the concentration parameter of paclitaxel within the coating matrix by creating a controlled gradient distribution. This parameter variation allows the coating to provide both immediate and sustained drug release, resolving the contradiction between simple uniform structure and effective therapeutic action

Inventive Principle:
Principle #35Parameter changes

2Reliability

If paclitaxel is applied without a controlled gradient distribution, then the coating application process is simple, but the drug release pattern is uncontrolled and bioavailability is insufficient

Engineering Contradiction:
Improvedrug release controlVSAvoidcoating application
Core Design Contradiction:
ReliabilityVSEase of manufacture

Solution Approach 1:

The patent prepares paclitaxel solutions in advance with specific concentrations before applying them to the balloon. By pre-configuring the drug solutions with controlled concentrations and applying them in a sequential manner through dip-coating, the system achieves controlled gradient distribution while maintaining manufacturing simplicity

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The shellac matrix serves as an intermediary carrier that controls the release pattern of paclitaxel. The biodegradable shellac matrix gradually degrades, mediating the release of paclitaxel from the coating onto the vessel wall in a controlled manner, thereby achieving both drug release control and manufacturing ease

Inventive Principle:
Principle #24Intermediary (Mediator)

3Reliability

If a gradient coating with high paclitaxel concentration is applied, then drug delivery effectiveness is improved, but the amount of shellac matrix increases which may affect coating detachment

Engineering Contradiction:
Improvedrug delivery effectivenessVSAvoidshellac matrix amount
Core Design Contradiction:
ReliabilityVSQuantity of substance

Solution Approach 1:

The gradient coating structure concentrates paclitaxel in specific regions (high concentration near the surface) rather than uniformly distributing it throughout the entire matrix. This local concentration strategy achieves effective drug delivery while minimizing the total shellac matrix required, as the drug is delivered where it is most needed

Inventive Principle:
Principle #3Local quality

Solution Approach 2:

The patent creates a composite coating system where paclitaxel and shellac are combined in a gradient structure. This composite material approach allows the shellac matrix to provide structural support and controlled release while the gradient distribution of paclitaxel ensures high drug delivery effectiveness without requiring excessive matrix material

Inventive Principle:
Principle #40Composite materials

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 gradient coating ensures higher bioavailability and effectiveness of paclitaxel, suppressing neointimal hyperplasia and reducing restenosis by providing a concentrated and pure drug delivery directly to the vessel wall.

Implementation Method 1

the active agents are released during the balloon inflation at the stenosis, in order to penetrate the arterial wall segment

Methodology Applied
Scientific EffectDiffusion: Diffusion

Implementation Method 2

a coating with an active agent and shellac, wherein the coating comprises at least one layer

Methodology Applied
Scientific EffectBiodegradation: Decomposition (biological)

Data Source

PatentEP2729196B1Balloon surface coating
Publication Date: 2016.12.28 CARDIONOVUM Z O O
  • EP2729196B1 patent drawingFigure 1~2
  • EP2729196B1 patent drawingFigure 3
  • EP2729196B1 patent drawing

AI summary

The present invention relates to catheter balloons coated with a gradient coating comprising at least one active agent and shellac. Moreover the present invention relates to a special method for coating catheter balloons with a pharmacological active agent and the biodegradable composition shellac.