Balloon Protector with Distal Stop and Peel-Off Tabs
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Solution Overview
Problem
Existing balloon protectors do not adequately prevent the advancement of balloon catheters through introducer sheaths without first removing the protector, which can lead to exposure of the drug-coated balloon to fluids and other contaminants.
Innovation Solution
A balloon protector design featuring a balloon-covering section with a tip piece and a tabbed section that can be progressively split to completely peel off the balloon, including features such as a tapered tip for guidewire threading and an overlapping portion to prevent insertion into an introducer sheath.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a balloon protector is designed to cover and protect the drug-coated balloon during shipping and handling, then the integrity and safety of the balloon catheter is maintained, but the risk of accidental advancement through the introducer sheath without removing the protector increases
Solution Approach 1:
The patent applies preliminary action by designing the balloon protector with a pre-formed distal stop that prevents advancement before the protector is intentionally removed. The stop is created during manufacturing, establishing a mechanical barrier that proactively prevents the harmful event of accidental catheter advancement through the introducer sheath while maintaining balloon protection during shipping and handling.
2Object-affected harmful factors
If a balloon protector includes a distal stop to prevent advancement, then accidental exposure is prevented, but the complexity of the protector design increases
Solution Approach 1:
The patent applies segmentation by dividing the balloon protector into distinct functional zones: a distal stop portion that prevents advancement, a intermediate section that covers the balloon, and a proximal section with tabs for removal. This segmentation allows each portion to perform its specific function independently, achieving the safety goal of preventing accidental insertion while maintaining manageable design complexity through clear functional division.
3Ease of operation
If the balloon protector is designed to be peeled off the balloon, then easy removal is achieved, but the risk of incomplete removal or damage to the balloon increases
Solution Approach 1:
The patent applies local quality by creating a tabbed section at the proximal end of the balloon protector with tabs that extend beyond the main body. This localized feature provides a gripping point for removal without affecting the integrity of the balloon or the protective function of the remaining cover. The tabs are specifically designed with increased surface area and structural reinforcement to distribute removal forces, enabling easy peeling while protecting the balloon from damage.
Data Source
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AI summary
Disclosed herein are balloon protectors, balloon catheters including the balloon protectors, and methods thereof. The balloon protector (100) includes a balloon-covering section (106) and a tabbed section (110) proximal of the balloon-covering section. The balloon-covering section is configured to cover a drug-coated balloon of the balloon catheter. The balloon-covering section includes a tip piece (104) of the balloon protector coupled to a distal-end portion of a body piece of the balloon protector. The tabbed section includes a pair of tabs (122) configured to be continuously pulled away from each other to progressively split the balloon protector along the balloon-covering section until the balloon protector is completely peeled off the balloon. Beneficially, an outer diameter of the tip piece can provide a stop to prevent insertion of a balloon catheter into an introducer sheath while the balloon protector is covering a balloon of the balloon protector.