Helical Balloon Catheter Deflectable Section
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Solution Overview
Problem
There is a need for a balloon catheter that can provide radial outward force against a body lumen wall without causing occlusion, capable of varying expansive characteristics and navigating through tortuous anatomy.
Innovation Solution
The catheter design includes a deflectable section with an elastic material on one side and a flexible support material on the other, featuring an inflation lumen bounded by both, where a pull wire causes the section to deflect into a helical profile, allowing expansion without occluding the lumen, and optionally includes guidewire and fluid delivery lumens for enhanced navigation and functionality.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Force
If a balloon catheter is deployed to provide radial outward force against a body lumen wall, then the force is applied to open or maintain the lumen, but the lumen may become occluded
Solution Approach 1:
The catheter is divided into distinct functional segments: a proximal portion, a deflectable section with helical geometry, and a distal portion. The deflectable section is further segmented with an elastic material layer and a flexible support material layer, allowing differential expansion and force application while maintaining lumen patency through the helical structure's inherent geometry.
Solution Approach 2:
The deflectable section is configured with a helical (coil-like) geometry rather than a straight structure. This curvature allows the catheter to navigate tortuous anatomy while the helical shape itself prevents complete occlusion by creating a continuous passage through the deployed structure, enabling radial force application without blocking the lumen.
2Force
If the catheter is made rigid to provide stable radial force, then force application is improved, but the ability to navigate through tortuous anatomy is reduced
Solution Approach 1:
Different portions of the catheter have different mechanical properties: the proximal and distal portions are relatively rigid for stable force application, while the deflectable section incorporates a helical structure with specific material properties that provide flexibility for navigation. The elastic material layer in the deflectable section is specifically engineered to be flexible enough to navigate tortuous anatomy while still providing controlled expansion.
Solution Approach 2:
The deflectable section is designed to be dynamically deformable, allowing it to adapt its shape to navigate through tortuous anatomy during insertion, then stabilize into a helical configuration upon inflation to provide consistent radial force. The helical geometry allows the structure to dynamically respond to forces while maintaining structural integrity.
3Force
If the elastic material expands uniformly, then radial force is maximized, but the helical profile and flow path are compromised
Solution Approach 1:
The elastic material layer is positioned asymmetrically within the deflectable section, specifically on the outer diameter of the helical profile rather than uniformly distributed. This asymmetric positioning allows the elastic material to expand radially outward to maximize force application against the lumen wall while preserving the helical geometry and creating an open flow path through the center of the helix.
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
The catheter effectively applies radial force while maintaining flow through the body lumen, allowing for navigation and deployment of medical devices without occluding the vessel, and can be configured for various anatomical paths and procedures.
Implementation Method 1
an elastic material on a first side... where when a pressure within the inflation lumen increases, the elastic material expands away from the inflation lumen
Implementation Method 2
a pull wire extending through the flexible support material at least along the length of the deflectable section and at least to the proximal portion of the catheter, such that proximal tension applied to the pull wire causes the deflectable section to deflect into a helical profile
Data Source
AI summary
Methods and devices described for improved catheters including those having a deflectable section to allow for expansion while maintaining flow through a vessel.