Drug Delivery Balloon Pre-Annealing for Uniform Coating
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Solution Overview
Problem
Existing drug delivery balloons face challenges in achieving uniform drug coatings due to non-uniform coating distribution and interference with folding machinery, leading to reduced coat weight uniformity and operational issues.
Innovation Solution
A method involving pre-annealing of the balloon to induce fold/wrap memory, followed by unfolding and applying a drug coating, then slowly evacuating to refold and rewrap the balloon, allowing for a uniform and durable coating without the need for conventional folding machinery.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Manufacturing precision
If a folded and wrapped balloon is coated using conventional folding machinery, then the balloon can be folded and wrapped, but the coating becomes non-uniform and material is left on the contacting parts of the folding machinery
Solution Approach 1:
The balloon is pre-annealed before coating to induce fold/wrap memory, creating predetermined fold lines that guide subsequent folding. This preliminary structural preparation ensures that the balloon folds along consistent paths during coating and evacuation, preventing material residue on machinery and ensuring uniform coating distribution.
Solution Approach 2:
The patent replaces conventional mechanical folding machinery with a chemical/thermal approach using annealing to induce fold memory in the balloon material. The fold/wrap memory allows the balloon to self-fold along predetermined lines without complex mechanical folding apparatus, eliminating the problem of material residue on machinery.
2Ease of manufacture
If the balloon is coated while folded and wrapped, then coating can be applied, but the coating texture and thickness vary depending on fold completion and spacing
Solution Approach 1:
The balloon undergoes pre-annealing to establish fold/wrap memory with precise fold lines before coating application. This ensures that when the balloon is folded during coating, the folds are consistent and predictable, allowing for uniform coating thickness and texture across the entire surface.
Solution Approach 2:
The patent uses thermal annealing to change the physical parameters of the balloon material, creating a memory effect that defines precise fold geometry. This parameter change ensures consistent fold spacing and completion, which directly translates to uniform coating properties during subsequent coating and evacuation steps.
3Ease of operation
If conventional folding machinery is used to fold and wrap the coated balloon, then the balloon can be folded, but operational issues arise due to material interference
Solution Approach 1:
The patent replaces mechanical folding systems with a thermal annealing process that induces fold/wrap memory in the balloon material. This eliminates the need for complex folding machinery that contacts the coated surface, preventing operational issues and material interference while maintaining ease of folding through the memory effect.
Solution Approach 2:
The balloon material itself serves the folding function through its induced fold/wrap memory. The annealed material automatically folds along predetermined lines during evacuation without requiring external mechanical assistance, eliminating operational issues with folding machinery while maintaining ease of operation.
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 method results in a substantially uniform and durable drug coating that maintains effectiveness during deployment, providing consistent drug delivery to the treatment site while avoiding operational issues with folding machinery.
Implementation Method 1
subjecting a balloon catheter with a folded and wrapped balloon thereon to a pre-annealing step to induce a fold/wrap memory in the resulting pre-annealed balloon
Implementation Method 2
unfolding the pre-annealed balloon sufficiently to expose the full circumferential surface of the balloon by application of an inflation pressure that retains said fold/wrap memory
Implementation Method 3
evacuating the balloon slowly to induce refolding and rewrapping of the balloon
Data Source
AI summary
A method of producing a drug coated balloon that comprises the steps of: subjecting a balloon catheter with a folded and wrapped balloon thereon to a pre-annealing step to induce a fold/wrap memory in the resulting pre-annealed balloon; unfolding the pre-annealed balloon sufficiently to expose the full circumferential surface of the balloon by application of an inflation pressure that retains said fold/wrap memory; applying a drug coating formulation to the unfolded balloon surface; releasing pressure to relax the balloon and induce creasing along fold memory; and evacuating the balloon slowly to induce refolding and rewrapping of the balloon. The method overcomes the need to use a folding apparatus to fold and wrap a drug coated balloon.