Drug-Coated Balloon Nanocrystals for Predictable Tissue Uptake
Find Innovative SolutionsGenerate Solutions
Solution Overview
Problem
Current drug delivery balloons using paclitaxel coatings suffer from unpredictable drug distribution and release, with non-uniform particle distribution leading to variable tissue uptake and extended release kinetics affected by amorphous and crystalline morphologies, resulting in inefficiencies and potential negative effects.
Innovation Solution
The use of nanocrystalline drug particles of controlled size and morphology applied to the balloon surface, accompanied by tracer particles for monitoring, and a textured surface to enhance drug carrying capacity, ensures predictable drug delivery and release.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Quantity of substance
If paclitaxel is applied directly to the balloon or formulated with excipients and sprayed/dip-coated on the balloon surface, then the drug can be delivered to the tissue site, but the drug matrix breaks into large pieces upon deployment leading to non-uniform distribution and unpredictable therapeutic levels
Solution Approach 1:
The patent segments the drug matrix into nanocrystalline particles with controlled size distribution (10-100 nm) rather than allowing it to break into large unpredictable pieces. This is achieved by pre-formulating paclitaxel as nanocrystals and loading them onto the balloon surface, ensuring uniform particle size that prevents non-uniform distribution upon deployment.
Solution Approach 2:
The patent performs preliminary action by pre-establishing the nanocrystalline structure of paclitaxel before applying it to the balloon. The nanocrystals are prepared in advance with controlled size distribution and then loaded onto the balloon surface, so that when the balloon is deployed, the particles maintain their integrity and uniform size rather than breaking apart.
2Quantity of substance
If large chunks of drug matrix are delivered to the vessel wall, then drug delivery is achieved, but the distribution over the vessel wall becomes non-uniform with voids at other places
Solution Approach 1:
The patent changes the critical parameter of particle size from micrometer-scale chunks to nanometer-scale crystals (10-100 nm). This parameter change enables the drug particles to distribute uniformly across the vessel wall surface, eliminating voids and ensuring complete coverage while maintaining adequate drug quantity for therapeutic effect.
3Reliability
If micrometer sized particles are used, then some uptake into tissue occurs, but absorption is variable and some particles hang on the wall or float downstream
Solution Approach 1:
The patent changes the particle size parameter from micrometer scale to nanometer scale (10-100 nm). This parameter change fundamentally improves tissue uptake reliability because nanocrystals are better absorbed by cells through enhanced permeability and cellular internalization mechanisms, while their small size prevents them from hanging on the vessel wall or floating downstream.
4Ease of manufacture
If paclitaxel is sprayed in solution, then the coating is applied to the balloon surface, but the drug ends up in an unknown mixture of amorphous and crystalline nature affecting extended release kinetics
Solution Approach 1:
The patent performs preliminary action by pre-establishing the crystalline morphology of paclitaxel in the form of nanocrystals before applying to the balloon. This ensures that the drug maintains a known and controlled crystalline structure throughout the coating process, eliminating the unknown mixture of amorphous and crystalline forms that would result from spraying solutions.
Solution Approach 2:
The patent changes the physical state parameter of paclitaxel from solution phase to solid nanocrystalline phase before application. This parameter change ensures that the drug maintains its crystalline structure during coating application, providing predictable extended release kinetics rather than the variable behavior associated with amorphous-crystalline mixtures.
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
This approach provides controlled drug delivery with uniform distribution, predictable tissue residence, and improved drug retention, allowing for precise dosage and extended therapeutic effect.
Implementation Method 1
it is known that single micrometer sized and nano-sized particles are better absorbed by cells
Data Source
AI summary
A drug delivery balloon (10) has a drug thereon in the form of crystalline particles (12), the drug having a predetermined size distribution. Optionally marker particles (14, 16) are also provided. A texturized coating (18), a cap layer (20) and/or other methods may be used to increase particle loading capacity of the balloon.