Focal Catheter for IRE and RF Ablation
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Solution Overview
Problem
Current ablation techniques for cardiac arrhythmias, such as RF ablation, face challenges in minimizing thermal damage to non-target tissues and organs, while newer methods like irreversible electroporation (IRE) offer a non-thermal approach but require advanced catheter designs capable of delivering precise electrical pulses for effective tissue ablation.
Innovation Solution
A catheter system configured with a linear distal portion, tip electrode, middle ring electrode, and proximal ring electrode, capable of delivering both RF electrical current and IRE pulses, allowing for unipolar, bipolar, or combined ablation modes, with integrated irrigation ports and thermocouples for temperature control, and a contact force sensor for precise tissue interaction.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If RF ablation is used to treat cardiac arrhythmias, then effective tissue ablation is achieved, but thermal damage to non-target tissues and organs occurs
Solution Approach 1:
The catheter is divided into multiple functional segments: a distal electrode array for IRE delivery, an intermediate electrode for RF ablation, and a proximal electrode for reference. This segmentation allows different ablation modalities to be applied at different locations along the catheter shaft, enabling selective treatment while protecting sensitive structures through proper positioning of each functional segment.
Solution Approach 2:
The system changes the physical parameter of energy delivery from continuous thermal RF energy to pulsed electric field IRE. The IRE pulses (high voltage, microsecond duration) create irreversible electroporation in target tissue without significant heat generation, fundamentally changing the ablation mechanism to avoid thermal damage to surrounding tissues while maintaining effective tissue destruction.
2Object-affected harmful factors
If IRE pulses are delivered to achieve non-thermal ablation, then thermal damage to surrounding tissues is reduced, but precise delivery of electrical pulses requires advanced catheter designs
Solution Approach 1:
The catheter is designed with multi-functionality to perform both IRE and RF ablation through different electrode configurations. The distal electrode array can deliver IRE pulses in various configurations (bipolar between adjacent electrodes, or unipolar relative to the proximal electrode), while the intermediate electrode enables RF ablation. This universal design consolidates multiple treatment capabilities into a single device, managing complexity through integration rather than requiring separate catheters for each modality.
Solution Approach 2:
The catheter structure itself acts as an intermediary that translates complex electrical pulse requirements into effective tissue treatment. The specific arrangement of electrodes along the catheter shaft mediates the delivery of IRE pulses, ensuring proper current distribution and field configuration without requiring external complex positioning systems or additional components.
3Adaptability or versatility
If multiple electrodes are configured for both IRE and RF ablation, then treatment versatility is improved, but device complexity increases
Solution Approach 1:
The catheter employs dynamic electrode configuration where the same physical electrodes can be activated in different patterns depending on treatment requirements. The system can dynamically switch between bipolar IRE (using adjacent distal electrodes), unipolar IRE (using distal electrodes relative to proximal electrode), and RF ablation (using the intermediate electrode). This dynamic reconfiguration capability provides treatment versatility without requiring separate fixed electrode structures for each modality.
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 system enables simultaneous or interleaved RF and IRE ablation, reducing thermal risks and improving precision, thereby effectively treating cardiac arrhythmias with reduced tissue damage and increased safety.
Implementation Method 1
The tip electrode can be configured to provide radio frequency (RF) ablation electrical signals
Implementation Method 2
Ablation by irreversible electroporation (IRE), referred throughout this disclosure interchangeably as pulsed electric field (PEF) ablation and pulsed field ablation (PFA) is a more recently developed technique in which electric potential (voltage) is applied across target tissue which disrupts cellular structures of myocardium and cause cell death
Implementation Method 3
The tip electrode can include thermocouples therein
Data Source
AI summary
Examples presented herein generally include a catheter and a system configured to deliver electrical pulses for ablation by IRE and methods for constructing and using the same. The catheter and system can further be configured to delivery RF electrical current for thermal ablation interleaved with ablation by IRE, simultaneously with ablation by IRE, and/or separately from ablation by IRE. The catheter can have a linear distal portion with a tip electrode, a middle ring electrode, and a proximal ring electrode. The electrodes be configured in several combinations to provide unipolar ablation, bipolar ablation, and/or a combination thereof.