Drug-Coated Balloon Coating Retention During Folding
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Solution Overview
Problem
Drug-coated balloons face challenges in retaining therapeutic agents during folding and assembly, leading to potential damage, loss, or contamination, which affects the efficacy of drug delivery in treating atherosclerosis.
Innovation Solution
A method and system for coating an expandable medical device, such as a balloon catheter, involving inflation to a partial pressure, applying a therapeutic agent, and then partially deflating while applying an external force to maintain the coating without damage or loss, using a mandrel for alignment and controlled deflation to ensure uniform coating retention.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If the balloon is folded and assembled after coating with therapeutic agent, then the device can be stored and delivered, but the therapeutic agent may be damaged, lost, or contaminated
Solution Approach 1:
The balloon is inflated to a partial pressure before coating with the therapeutic agent, creating a controlled environment that prevents damage during subsequent folding and assembly operations. This preliminary inflation action establishes the proper configuration for safe coating and handling.
Solution Approach 2:
The balloon transitions through different pressure states (inflated to partial pressure during coating, then deflated for folding and assembly). This dynamic pressure control allows the balloon to be in the optimal state for each manufacturing operation, preventing therapeutic agent damage while enabling easy folding and assembly.
2Manufacturing precision
If the balloon is inflated to full pressure for coating, then uniform coating is achieved, but folding and assembly become difficult
Solution Approach 1:
The inflation pressure is changed from full pressure (used for achieving uniform coating) to a partial pressure (used for facilitating folding and assembly). This parameter change allows the system to optimize for coating uniformity during the coating operation, then optimize for ease of folding during assembly operations.
3Volume of moving object
If the balloon is deflated completely for folding, then compact storage is achieved, but therapeutic agent loss or contamination increases
Solution Approach 1:
The balloon is inflated to a partial pressure before coating, creating a stable configuration that prevents therapeutic agent loss during folding. This preliminary action establishes conditions that protect the therapeutic agent while still allowing compact folding for storage.
Solution Approach 2:
The partial inflation pressure acts as a cushioning mechanism that protects the therapeutic agent coating during folding and assembly operations. This beforehand cushioning prevents damage and contamination that would occur with complete deflation, while still enabling compact storage.
Data Source
AI summary
Device, system, method of coating an expandable member is provided. The method comprises providing an expandable member with a plurality of folds defined therein, the expandable member having a folded configuration and a fully expanded configuration at a rated nominal pressure. The expandable member is inflated to an initial pressure of from 10% to about 300% of nominal pressure. A therapeutic agent is disposed on at least a portion of the expandable member. The expandable member is partially deflated to an intermediate pressure by withdrawing an amount of inflation medium from the expandable member, and by applying an external force to the expandable member.