Drug-Coated Balloon Coating for Controlled Vascular Drug Release
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Solution Overview
Problem
Existing drug coated balloons face challenges in providing sufficient initial drug dosage, stable polymer coating, and controlled drug release, especially with sirolimus due to its low lipophilicity, leading to potential safety hazards and inefficiencies in vascular drug delivery.
Innovation Solution
A drug coated balloon with a non-hydrophilic structure containing a first and second controllable sustained release drug component with different kinetics, and an active drug in a free unbound form, encapsulated in biocompatible and biodegradable polymers, ensures controlled drug release and improved vascular drug transfer.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Quantity of substance
If a drug coated balloon uses a large dose of active drug to ensure sufficient initial drug delivery, then the drug delivery efficacy is improved, but the risk of drug loss and safety hazards increases
Solution Approach 1:
The drug coating is segmented into multiple layers with different functions: a hydrophilic polymer layer for controlled release and a lipophilic layer for drug retention. This segmentation allows the balloon to carry sufficient drug dosage while reducing drug loss through structured delivery mechanisms.
Solution Approach 2:
The patent uses composite coating materials combining hydrophilic polymers (for controlled release) and lipophilic substances (for drug retention and transfer). This composite structure enables efficient drug delivery with reduced waste and improved safety by optimizing both drug retention on the balloon and transfer to the vessel wall.
2Quantity of substance
If the balloon contact time with the blood vessel wall is extended to improve drug transfer, then the drug delivery efficacy is improved, but the procedural complexity and time consumption increase
Solution Approach 1:
The patent changes the physical-chemical parameters of the coating materials to enhance drug transfer efficiency. By using lipophilic substances with appropriate logP values and controlling the coating thickness and composition, the balloon achieves effective drug transfer during the standard brief contact time, eliminating the need for extended procedures.
3Loss of substance
If a stable polymer coating system is implemented to reduce drug loss during tracking, then the drug retention is improved, but the coating complexity and manufacturing difficulty increase
Solution Approach 1:
The patent applies local quality by creating a coating with spatially varying properties: a hydrophilic layer facing the blood vessel for controlled release and a lipophilic layer for drug retention. This localized functional differentiation reduces drug loss during tracking while maintaining manageable coating complexity through targeted material placement.
4Object-affected harmful factors
If sirolimus is used as the active drug due to its safety profile, then the safety is improved, but the drug transfer to vascular wall becomes challenging due to low lipophilicity
Solution Approach 1:
The patent introduces a lipophilic intermediary layer in the coating system that facilitates the transfer of sirolimus (which has low inherent lipophilicity) to the vascular wall. This intermediary layer acts as a bridge, enhancing drug transfer efficiency while maintaining the safety benefits of using sirolimus as the active pharmaceutical ingredient.
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 balloon provides adequate initial drug loading, controlled long-acting therapeutic drugs, and enhances vascular drug release efficacy by adjusting drug release rates, addressing safety and efficiency issues.
Implementation Method 1
Each of the controllable sustained release drugs is encapsulated in a polymer as a carrier to form drug loaded particles
Implementation Method 2
a first drug loaded coating component including at least two controllable sustained release drugs with different drug release kinetics
Implementation Method 3
Both the first drug loaded coating component and the second drug loaded coatings component are non-hydrophilic compositions... ensuring the lipophilicity of the drug loaded coating, and ensuring the drug transfer ability to the vascular wall
Implementation Method 4
The stent is implanted and retained in the target lesion site... the drug is less likely to migrate to other locations in the body
Data Source
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AI summary
A drug coated balloon and a preparation method thereof are provided. The drug coated balloon includes a balloon body and a drug loaded coating layer. The drug loaded coating layer includes a first drug loaded coating component having at least two controllable sustained release drugs with different drug release kinetics, and a second drug loaded coating component including an active drug in a free unbound form. The second drug loaded coating component is dispersed among the controllable sustained release drugs in the first drug loaded coating component and couples the controllable sustained release drugs on the balloon body. The first and second drug loaded coatings component are both non-hydrophilic compositions. The drug coated balloon can provide sufficient initial drug loading dosage to the lesion site, and multiple controllable sustained release drugs having different drug release kinetics is able to avoid explosive drug release and extinction. The drug release rate can also be regulated through different combinations, thereby allowing the drug coated balloon to provide bioactive drugs to the treatment site at different stages of the cascade reaction of vascular restenosis, providing the controllable long-acting therapeutic drugs to the lesion site, and improving the overall vascular drug release efficacy.