Multi-Catheter Segmentation for Electroporation Voltage Control
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Solution Overview
Problem
Existing medical devices for electroporation ablation lack the ability to selectively and rapidly deliver high DC voltage to tissue, leading to inefficiencies and limitations in treating cardiac arrhythmias.
Innovation Solution
The development of catheter systems with a voltage pulse generator and an electrode controller that allow for the selective and rapid application of DC voltage to drive electroporation. This system includes a selection module to identify anode and cathode electrodes on separate catheters and a pulse delivery module to deliver pulsed voltage waveforms with specific polarities to these electrodes.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If substantial insulation is used around catheter leads to minimize dielectric breakdown, then reliability is improved, but device complexity and size increase
Solution Approach 1:
The patent divides the catheter system into multiple separate catheters, each carrying only electrodes of a single polarity (all anodes or all cathodes). This segmentation eliminates the need for complex insulation between opposite polarity leads within the same catheter, as each catheter contains only like-polarity electrodes. The segmentation approach maintains reliability by preventing dielectric breakdown while simplifying the insulation requirements for each individual catheter.
Solution Approach 2:
The patent introduces a controller as an intermediary device that coordinates the application of voltage pulses to multiple separate catheters. The controller manages the timing and polarity assignment of voltage pulses, enabling selective energy delivery to different tissue regions without requiring complex insulation within each catheter. This intermediary control system facilitates reliable high-voltage delivery while maintaining simpler catheter construction.
2Productivity
If high DC voltage is applied to drive electroporation, then productivity is improved, but the risk of dielectric breakdown increases
Solution Approach 1:
By segmenting the electrode system into multiple catheters with single-polarity electrodes, the patent enables application of high DC voltage pulses to drive electroporation effectively. Each catheter can be driven to high voltages without the dielectric breakdown risk that would exist if opposite polarity electrodes were in close proximity within the same catheter. This segmentation allows productive electroporation while maintaining safety.
Solution Approach 2:
The patent employs periodic pulsed voltage delivery to drive electroporation, where voltage pulses are applied in controlled sequences to multiple catheters. This periodic action allows tissue ablation through electroporation while providing intervals between pulses to minimize cumulative dielectric stress. The pulsed regime maintains productivity by delivering sufficient energy over time while reducing instantaneous dielectric breakdown risk.
3Manufacturing precision
If selective energy delivery is implemented across multiple catheters, then manufacturing precision is improved, but device complexity increases
Solution Approach 1:
The patent segments the ablation system into multiple independent catheters, each with simplified electrode configurations. This segmentation enables selective activation of specific electrodes or catheter combinations to achieve precise energy delivery to targeted tissue regions. The modular nature of segmented catheters facilitates manufacturing precision by allowing independent construction and testing of each catheter unit.
Solution Approach 2:
The patent employs a universal controller that can manage multiple catheters with identical or similar electrode configurations. This universal control architecture enables selective energy delivery by programming different activation patterns across the multiple catheters, achieving manufacturing precision without requiring each catheter to be uniquely complex. The multi-functional controller handles timing, polarity assignment, and pulse delivery coordination across the entire multi-catheter system.
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
Enables selective and rapid electroporation of cardiac tissue, improving the efficacy of ablation therapy for cardiac arrhythmias by allowing for precise energy delivery and minimizing the risk of dielectric breakdown.
Implementation Method 1
applying brief, high voltage DC pulses to tissue, thereby generating locally high electric fields, typically in the range of hundreds of Volts/centimeter. The electric fields disrupt cell membranes by generating pores in the cell membrane
Implementation Method 2
If the applied electric field at the membrane exceeds a threshold value, typically dependent on cell size, the electroporation, is irreversible and the pores remain open, permitting exchange of material across the membrane and leading to apoptosis or cell death
Data Source
AI summary
Catheter systems, tools and methods are disclosed for the selective and rapid application of DC voltage to drive irreversible electroporation, with the system controller configurable to apply voltages to an independently selected subsets of electrodes, such that voltages of one polarity are applied to a multiplicity of electrodes on a first medical device and voltages of the opposite polarity to a multiplicity of electrodes on a second medical device. The first and second medical devices can be epicardial catheters positioned such that their opposing distal tips are approximately aligned and whose segments with electrodes collectively wrap around the pulmonary veins.