Smooth-Equidistant Electrodes for Uniform IRE Field Distribution
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Solution Overview
Problem
Existing catheter designs for irreversible electroporation (IRE) ablation face challenges in maintaining consistent electric field strengths due to variable inter-electrode distances and sharp edges, leading to unpredictable clinical outcomes and potential thermal effects.
Innovation Solution
The use of an expandable frame with smooth-edged, equiangularly disposed electrodes on a catheter, ensuring uniform lateral distance between adjacent electrodes, which minimizes thermal effects and allows for consistent electric field application between electrodes.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Object-affected harmful factors
If traditional ablation electrodes with gaps are used on the balloon, then the electrodes can be manufactured with simpler geometry, but thermal effects occur in tissue contact with gaps due to heat conduction from nearby ablated tissue
Solution Approach 1:
The patent changes the geometric parameters of the electrodes by adding smooth rounded edges instead of sharp corners and gaps. This modifies the electric field distribution to eliminate thermal effects while maintaining manufacturability through standard fabrication processes for rounded electrode geometries.
Solution Approach 2:
The patent converts the potential harmful thermal effects from gap regions into a beneficial design feature by deliberately rounding all electrode edges. This ensures uniform electric field distribution and prevents thermal damage, turning what could be a manufacturing complication into a therapeutic advantage.
2Reliability
If electrodes with variable inter-electrode distances are used, then the catheter design is simpler, but the electric field strength becomes unpredictable leading to inconsistent clinical outcomes
Solution Approach 1:
The patent establishes a fixed parameter for inter-electrode distance, ensuring uniform spacing between all adjacent electrodes around the balloon circumference. This standardized spacing parameter guarantees consistent electric field strength and predictable clinical outcomes while remaining compatible with standard catheter manufacturing capabilities.
3Object-affected harmful factors
If sharp-edged electrodes are used, then manufacturing is easier, but excessive heat is generated at sharp edges causing unpredictable thermal effects
Solution Approach 1:
The patent modifies the edge geometry parameter of the electrodes by specifying smooth rounded edges with a defined radius of curvature. This parameter change eliminates excessive heat generation at sharp edges while the rounded geometry can be achieved through standard fabrication methods such as laser cutting with appropriate parameters or precision molding.
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
This configuration enables more predictable and effective cardiac IRE ablation with reduced collateral damage, improving the clinical outcome for treating cardiac arrhythmia by maintaining uniform electric field strengths and minimizing thermal effects.
Implementation Method 1
the electrodes are configured to apply irreversible electroporation (IRE) pulses to tissue between pairs of the electrodes
Implementation Method 2
a lateral distance between neighboring edges of any pair of adjacent electrodes is uniform along a longitudinal axis... minimizing thermal effects
Data Source
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Figure 2
AI summary
A system includes a catheter and an IRE pulse generator. The catheter includes an expandable frame fitted at a distal end thereof, the expandable frame including multiple electrodes configured to be placed in contact with a tissue in an organ of a patient, wherein a lateral distance between neighboring edges of any pair of adjacent electrodes is uniform along a longitudinal axis, and wherein the electrodes are configured to apply irreversible electroporation (IRE) pulses to tissue between pairs of the electrodes. The IRE pulse generator is configured to generate the IRE pulses.