IRE/RFA Waveform Interleaving for Cardiac Tissue Ablation
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Solution Overview
Problem
Existing methods for delivering radiofrequency ablation (RFA) and irreversible electroporation (IRE) treatments separately may not be effective in certain applications, such as cardiac treatments, due to factors like cardiac motion, and there is a need for a more effective combined treatment approach.
Innovation Solution
A generator system that simultaneously delivers intertwined IRE and RFA waveforms, allowing for the interleaving of IRE pulses with RF cycles on a sub-second scale, thereby enabling joint delivery of both treatments to the same tissue location.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If separate RFA and IRE treatments are delivered sequentially, then each treatment can be optimized independently, but the overall treatment effectiveness is reduced due to tissue movement and incomplete ablation
Solution Approach 1:
The patent combines RFA and IRE treatments into a single integrated system that delivers both waveforms simultaneously through the same electrode array. The controller coordinates the delivery of RF waves and IRE pulses in an interleaved manner, merging two separate treatment processes into one unified treatment session. This eliminates the need for sequential treatment delivery and addresses tissue movement issues by treating the same tissue location concurrently with both modalities.
2Reliability
If RFA and IRE are delivered simultaneously through the same electrode, then treatment effectiveness is improved, but waveform interference and signal quality deteriorate
Solution Approach 1:
The patent segments the waveform generation process into separate dedicated modules: an RF wave generator for producing continuous radiofrequency waves and an IRE pulse generator for producing high-voltage pulsed electric fields. The controller then selectively interleaves these pre-generated waveforms, delivering them through the same electrode at different time intervals. This segmentation allows each waveform type to be optimized independently while avoiding interference during simultaneous delivery.
Solution Approach 2:
The controller implements periodic action by interleaving RF wave cycles with IRE pulse deliveries in a structured temporal pattern. The system alternates between delivering RF waves and IRE pulses at controlled intervals, creating a periodic delivery schedule that prevents waveform interference while maintaining continuous treatment effect on the target tissue.
3Reliability
If high voltage IRE pulses are delivered, then cell necrosis is achieved, but thermal heating and collateral damage increase
Solution Approach 1:
The patent applies continuous RF wave delivery between IRE pulses to maintain thermal heating action continuously throughout the treatment. The RF waves provide uninterrupted thermal energy to the tissue, ensuring that cells are heated consistently while IRE pulses are delivered at intervals to create necrotic lesions. This continuous useful action from RF waves compensates for the intermittent nature of IRE pulses and maintains treatment effectiveness.
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 combined IRE/RFA treatment approach enhances the effectiveness of tissue ablation by ensuring that tissue insufficiently destroyed by one modality is fully ablated by the other, potentially improving clinical outcomes in invasive treatments like cardiac arrhythmia therapy.
Implementation Method 1
apply a second sequence of electrical pulses to the central electrode to induce cell necrosis in the tissue by irreversible electroporation
Implementation Method 2
The harmonic filtration circuitry is configured to convert the IRE pulses into an RF signal
Implementation Method 3
apply a first sequence of electrical pulses to the electrode array to induce thermal heating in the tissue
Implementation Method 4
The waveform interleaver, which is configured to receive the IRE pulses and the RF signal and generate an IRE/RFA output signal by interleaving in alternation one or more of the IRE pulses with one or more periods of the RF signal
Data Source
AI summary
An irreversible electroporation and radio frequency ablation (IRE/RFA) generator includes an IRE pulse generator, harmonic filtration circuitry, and a waveform interleaver. The IRE pulse generator is configured to generate biphasic IRE pulses. The harmonic filtration circuitry is configured to convert the IRE pulses into an RF signal. The waveform interleaver, which is configured to receive the IRE pulses and the RF signal and generate an output signal having a composition of the adapted IRE pulses having a final shape and repetition rate, the converted RF sinusoidal signal, or a combined IRE/RFA output signal, by switching between the received IRE square pulses and the received converted RF sinusoidal signal.