Cutting Balloon Folding Tool for Uniform, Damage-Resistant Folds
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Solution Overview
Problem
Existing medical balloon folding systems result in non-uniform folds, leading to variability in profile and potential damage, which affects burst pressure and assembly ease, especially when cutting and scoring elements are present.
Innovation Solution
A tool with a housing and radially displaced blade and balloon pusher elements, allowing independent actuation and varied inward end configurations, is used to impart uniform folds on medical balloons.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Volume of moving object
If conventional folding systems are used to reduce balloon profile, then the balloon can be compressed to fit delivery catheters, but the folds become non-uniform causing variability in profile and potential balloon damage
Solution Approach 1:
The folding tool is divided into multiple independently actuatable balloon pusher members (at least two per balloon pusher element) that can be controlled separately. This segmentation allows each member to independently form specific folds, ensuring uniform fold geometry throughout the balloon circumference while maintaining reduced profile for delivery catheter compatibility.
Solution Approach 2:
The balloon pusher members are designed with independent actuation capability, allowing dynamic control of each member's position and movement. This enables real-time adjustment during the folding process to maintain consistent fold uniformity while achieving the required profile reduction, preventing balloon damage that would occur with static, non-uniform folding.
2Object-affected harmful factors
If folding is performed to protect anatomy from cutting elements, then the balloon and blades are protected during delivery, but non-uniform folds cause variability in burst pressure and rewrap characteristics
Solution Approach 1:
By segmenting the balloon pusher into multiple independently controlled members, each member can be precisely positioned to create uniform folds that consistently contain cutting elements during delivery. This uniform containment protects anatomy from blade exposure while ensuring consistent fold structure that maintains reliable burst pressure and rewrap characteristics.
Solution Approach 2:
Different balloon pusher members can be independently actuated to create locally optimized fold patterns. This allows specific regions of the balloon to have enhanced protection for cutting elements while maintaining overall fold uniformity, ensuring both anatomy protection during delivery and consistent reliability for burst pressure and rewrap performance.
3Device complexity
If simple folding mechanisms are used, then the device complexity is reduced, but the ease of assembly and fold uniformity deteriorate
Solution Approach 1:
The balloon pusher is segmented into multiple members that can be independently actuated, providing precise control for uniform folds. Despite this increased internal complexity, the overall device remains manageable through coordinated control of the segmented members, achieving both fold uniformity and acceptable assembly ease.
Solution Approach 2:
The dynamically controllable balloon pusher members allow for programmable folding sequences that simplify the assembly process. By controlling each member's movement independently, the system can automatically achieve uniform folds without requiring complex manual intervention, balancing device complexity with ease of operation.
Data Source
AI summary
Tools for imparting a plurality of folds to a balloon. An illustrative tool may include a housing defining a central aperture extending along a length of the housing, a plurality of blade pusher elements spaced about a circumference of the housing, and a plurality of balloon pusher elements spaced about a circumference of the housing. The plurality of blade pusher elements may each extende from a radially outward edge to a radially inward portion configured to extend into the central aperture. The plurality of balloon pusher elements may each extend from a radially outward edge to a radially inward end configured to extend into the central aperture. Each balloon pusher element of the plurality of balloon pusher elements may comprise two or more balloon pusher members.