Balloon Refolding Device for Uniform Deflation and Blade Nesting
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Solution Overview
Problem
Balloon catheters face challenges during deflation, as uneven collapse can cause irregular bulges, making removal difficult, and cutting balloons risk incising tissue due to sharp blades, necessitating a solution for predictable folding and blade protection during deflation.
Innovation Solution
A device with first and second bands on the catheter tube, featuring elastic members that expand with the balloon during inflation and recover to fold it compactly onto the tube, ensuring uniform deflation and nesting blades within pleats to prevent tissue incision.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If the balloon is deflated without a folding device, then the deflation process is simple, but the balloon collapses unevenly causing irregular bulges that make removal difficult
Solution Approach 1:
The balloon surface is segmented into multiple sections by the elastic members, which divide the balloon into zones that collapse in a controlled sequence. This segmentation prevents uneven collapse and irregular bulges, enabling smooth balloon withdrawal from the artery.
Solution Approach 2:
The elastic members are pre-positioned on the balloon surface before deflation begins. During deflation, these pre-positioned members automatically engage and guide the folding process, ensuring the balloon collapses uniformly without requiring external intervention or complex control mechanisms.
2Reliability
If cutting balloons are used to treat stenoses, then vessel recoil is minimized and restenosis rate is lowered, but the sharp blades risk inadvertently incising non-target tissue during movement
Solution Approach 1:
The blades are nested within grooves or channels in the balloon structure, and during deflation they become embedded within the folded balloon layers themselves. This nesting configuration keeps the sharp blades enclosed and protected, preventing them from contacting or incising the arterial wall during catheter movement.
Solution Approach 2:
The elastic members and balloon pleats act as intermediary protective layers between the sharp blades and the surrounding tissue. As the balloon deflates, the elastic members guide the blades into a retracted position where they are shielded by the folded balloon material, eliminating direct contact with non-target tissue.
3Ease of operation
If the balloon deflates uniformly into a predictable configuration, then the balloon can be easily withdrawn from the artery, but requiring a folding mechanism increases device complexity
Solution Approach 1:
The elastic members are self-actuating components that automatically engage and drive the folding process during balloon deflation. They utilize the balloon's own deflation pressure to activate the folding mechanism, eliminating the need for external actuators, motors, or complex control systems while ensuring uniform collapse and easy withdrawal.
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
Facilitates easy and safe removal of the balloon catheter by ensuring uniform deflation and protecting against tissue injury by keeping blades nestled, enhancing the safety and efficacy of angioplasty procedures.
Implementation Method 1
Each elastic member extends between a distal end that is attached to the first band and a proximal end that is attached to the second band. Each elastic member is positioned for interaction with the outer surface of the balloon
Data Source
AI summary
A device for folding a balloon of a balloon catheter onto a catheter tube during a balloon deflation includes a first band positioned on the catheter tube distal to the balloon and a second band positioned on the catheter tube proximal to the balloon. One or more elastic member(s) are attached to and extend between the bands for interaction with the outer surface of the balloon. During a balloon deflation, the elastic members cooperate to fold the balloon into pleats. When used on a cutting balloon, each elastic member is formed with a slot to allow a respective blade of the cutting balloon to extend through the elastic member. The elastic members fold the cutting balloon into a configuration in which each blade becomes nestled within a pair of adjacent balloon pleats to prevent the blade from inadvertently incising tissue during an in-vivo movement of the balloon catheter.