Weeping Balloon Catheter Dual-Layer Coating
Find Innovative SolutionsGenerate Solutions
Solution Overview
Problem
Existing balloon catheters face challenges in delivering therapeutic agents uniformly and consistently to body vessel walls, leading to inconsistent therapeutic effects due to issues with solubility, integrity, and uniformity of coatings, and require bedside measurement and mixing of therapeutic agents.
Innovation Solution
A drug-coated weeping balloon catheter with a perforated outer balloon and an inner balloon, where a carrier is used to enhance the elution rate of bioactive agents through apertures, allowing for pre-determined effective delivery without bedside mixing or measurement.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Quantity of substance
If a coating solution including therapeutic agent, contrast agent, and additives is applied to the catheter balloon, then the therapeutic agent can be delivered to the target site, but the solubility increases causing the drug to wash away during translation to the target site
Solution Approach 1:
The coating is segmented into distinct functional layers: a hydrophobic polymer matrix that retains the therapeutic agent, and a hydrophilic outer layer that controls release. This segmentation prevents premature washing away while enabling controlled delivery at the target site.
Solution Approach 2:
A hydrophobic polymer intermediary layer is introduced between the therapeutic agent and the aqueous environment. This intermediary prevents direct contact between the water-soluble drug and body fluids during catheter translation, eliminating premature washaway while allowing controlled release at the target site.
2Strength
If more contrast media is mixed with the therapeutic agent, then the coating becomes less crystalline and more durable, but clumps form that easily flake off during handling
Solution Approach 1:
Different regions of the coating have different properties: the inner layer contains therapeutic agent with controlled crystallinity for durability, while the outer hydrophilic layer provides uniform surface characteristics. This local quality differentiation maintains durability without compromising uniformity.
Solution Approach 2:
The coating uses a composite structure combining hydrophobic and hydrophilic polymers in specific ratios and configurations. This composite material approach allows the therapeutic agent to be embedded in a durable matrix while the outer layer ensures uniform surface properties and prevents clumping.
3Ease of operation
If the therapeutic agent is delivered systemically, then treatment can be administered easily, but areas of the body not needing treatment are also affected
Solution Approach 1:
The therapeutic agent is extracted from systemic circulation and concentrated locally at the target site through the catheter delivery system. The coating design ensures the agent remains trapped during delivery and only releases at the intended location, eliminating off-target effects while maintaining ease of administration.
Solution Approach 2:
The coating provides continuous controlled release of the therapeutic agent at the target site after deployment. This continuous local delivery maintains therapeutic effectiveness while preventing systemic distribution, thereby avoiding off-target effects.
4Adaptability or versatility
If a pre-mixed therapeutic agent solution is prepared at the bedside, then the delivery can be customized, but the process requires additional time and measurement steps
Solution Approach 1:
The therapeutic agent is pre-loaded into the catheter coating during manufacturing with predetermined concentrations and distributions. This preliminary action eliminates the need for bedside mixing and measurement, reducing preparation time while maintaining the ability to select from pre-configured dosing options.
Solution Approach 2:
The catheter system is designed with universal applicability through pre-configured coating options that can accommodate different therapeutic agents and dosing requirements. This multi-functionality allows customization for different patients without requiring complex bedside preparation procedures.
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 weeping balloon catheter achieves enhanced and rapid delivery of bioactive agents, reducing the amount required and time needed for effective treatment, with improved elution rates and reduced variability, ensuring consistent therapeutic outcomes.
Implementation Method 1
The inner balloon is inflated to expand the outer balloon to press against a body vessel wall
Implementation Method 2
A carrier is used to enhance the elution rate of the bioactive agent through the apertures
Data Source
AI summary
Catheter balloons (10) for delivering a bioactive (260) to a body vessel in a greater amount and/or more quickly are provided, as well as related methods of treatment. The catheter balloon may include a dual balloon assembly at the distal portion (300) of the catheter having an inner balloon (44), an outer balloon (42) with apertures (43) concentrically arrayed around the inner balloon, and a catheter shaft (30) adapted to deliver a carrier (270) through the apertures of the outer balloon. The bioactive is disposed on a portion of at least one of the inner and outer balloon surfaces. Radial outward expansion of the inner balloon urges the outer balloon into contact with the wall of the body vessel. The carrier is introducible within the catheter shaft to pass through the annular lumen (242) between the balloons and through the apertures of the outer balloon. The carrier interacts with the bioactive in order to release a therapeutically effective amount of drug to the wall of the body vessel.