Balloon Catheter Distal Termination Nesting
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Solution Overview
Problem
Current balloon catheters with single distal tip electrodes require a long time to accumulate data for detailed cardiac maps due to the need for point-by-point measurement, limiting the efficiency of arrhythmia treatment and mapping processes.
Innovation Solution
A balloon catheter design where the distal termination is housed within the balloon, allowing for a smooth external shape and the inclusion of a magnetic coil sensor and guide wire, enabling simultaneous multi-point electrical activity measurement and efficient data acquisition.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Device complexity
If a single distal tip electrode is used in a balloon catheter, then the structure is simple, but the data acquisition time is excessively long due to point-by-point measurement requirements
Solution Approach 1:
The catheter is segmented into distinct functional zones: a distal electrode array for simultaneous multi-point measurement, a mid-section for structural support, and a proximal control section. The electrode array itself is segmented into multiple independently positioned electrodes that can measure electrical activity at multiple locations simultaneously, eliminating the need for point-by-point measurement.
Solution Approach 2:
The invention transitions from one-dimensional point-by-point measurement along the catheter axis to two-dimensional simultaneous measurement across multiple spatial points on the balloon surface. The electrodes are distributed across the balloon's surface area, enabling parallel data acquisition from multiple cardiac tissue locations at once.
2Ease of operation
If the distal termination protrudes from the balloon, then the electrode is accessible for measurement, but the external shape is irregular and may interfere with navigation
Solution Approach 1:
The distal termination structure is nested within the balloon envelope rather than protruding externally. The electrode array is positioned inside the balloon's volume, with conductive elements extending through the balloon wall to contact cardiac tissue. This nesting approach maintains a smooth external balloon shape while preserving electrode functionality.
Solution Approach 2:
The balloon wall acts as a flexible shell that contains the distal termination structures while allowing electrical and mechanical interaction with the surrounding environment. The thin film of the balloon wall permits electrode functionality without requiring external protrusion, maintaining both smooth external shape and measurement capability.
3Productivity
If multiple electrodes are added to measure electrical activity simultaneously, then mapping efficiency improves, but the device complexity and manufacturing difficulty increase
Solution Approach 1:
The balloon catheter serves multiple functions simultaneously: the balloon structure provides both mechanical support for positioning and a substrate for mounting electrodes; the electrode array performs both electrical measurement and serves as a reference for mapping; the distal termination structure provides both structural integrity and electrode support. This multi-functionality reduces the need for separate dedicated components.
Solution Approach 2:
The invention merges the balloon structure with the electrode mounting structure, combining what could be separate components into an integrated assembly. The distal termination is merged with the electrode array, and both are integrated into the balloon structure, simplifying the overall device architecture while enabling simultaneous multi-point measurement.
4Shape
If the distal termination is housed within the balloon, then the external shape is smooth for better navigation, but the electrode accessibility and signal quality may be compromised
Solution Approach 1:
The balloon wall serves as an intermediary structure that enables electrical signal transmission while maintaining a smooth external shape. The electrode array positioned within the balloon uses the balloon wall and surrounding fluid medium as intermediaries to achieve electrical contact with cardiac tissue, preserving signal quality without requiring external protrusion.
Solution Approach 2:
The invention changes the operational parameters of the electrode system by positioning electrodes within the balloon's internal volume rather than externally. This parameter change in electrode location is compensated by adjusting the electrical configuration and signal acquisition parameters to maintain measurement precision despite the different physical arrangement.
Data Source
AI summary
A catheter adapted to slidably receive a hollow shaft through its lumen. An expandable balloon is attached to the distal portion of the hollow shaft. A nose piece disposed at the front face of the balloon forms a connection between the balloon and the distal portion of the hollow shaft. When the balloon is expanded the nose piece does not protrude beyond the front face of the balloon.