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

VSEngineering 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

Engineering Contradiction:
Improveintegrity of balloon catheterVSAvoidaccidental exposure to fluids
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

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.

Inventive Principle:
Principle #10Preliminary action

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

Engineering Contradiction:
Improveprevention of accidental insertionVSAvoidcomplexity of balloon protector
Core Design Contradiction:
Object-affected harmful factorsVSDevice complexity

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.

Inventive Principle:
Principle #1Segmentation

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

Engineering Contradiction:
Improveease of removing balloon protectorVSAvoidintegrity of balloon during removal
Core Design Contradiction:
Ease of operationVSReliability

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.

Inventive Principle:
Principle #3Local quality

Data Source

PatentEP4093479B1Balloon protectors and balloon-catheter assemblies
Publication Date: 2025.06.18 BARD PERIPHERAL VASCULAR INC
  • EP4093479B1 patent drawingFigure 1~2
  • EP4093479B1 patent drawingFigure 3~4
  • EP4093479B1 patent drawingFigure 5~7

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.