Pretreatment Waveform Sequencing for Skeletal Muscle-Sparing IRE Ablation
Find Innovative SolutionsGenerate Solutions
Solution Overview
Problem
Existing ablation techniques like RF and cryoablation indiscriminately damage healthy tissue, while irreversible electroporation (IRE) can cause skeletal muscle stimulation (SMS), necessitating a method to deliver effective IRE energies without SMS.
Innovation Solution
An electroporation ablation system with a catheter and generator that includes a preconditioning pulse sequence to cause electrolysis and tetanize skeletal muscle stimulation, followed by an electroporation pulse sequence to create targeted tissue apoptosis, using a closed-loop system with an accelerometer to monitor and adjust pulse delivery.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If high voltage pulses are used to deliver effective IRE energies, then targeted tissue ablation is achieved, but skeletal muscle stimulation occurs
Solution Approach 1:
The patent applies preliminary action by delivering a preconditioning pulse sequence before the main IRE pulse sequence. The preconditioning pulses at lower voltages prepare the tissue and gradually acclimate the skeletal muscle system, reducing the likelihood of unwanted SMS during the subsequent high-voltage IRE pulses while maintaining ablation effectiveness
Solution Approach 2:
The patent employs parameter changes by systematically varying pulse voltage, duration, and inter-pulse intervals in a ramping sequence. The voltage increases from lower preconditioning levels to higher IRE levels, while pulse durations and intervals are adjusted to optimize tissue permeabilization while staying below the SMS threshold
2Object-affected harmful factors
If IRE pulse strength is reduced to avoid skeletal muscle stimulation, then SMS is minimized, but ablation lesion size decreases
Solution Approach 1:
The preconditioning pulse sequence performs preliminary action by creating initial permeabilization pathways in the cell membranes at lower voltages. This preparatory step reduces the threshold for irreversible electroporation, allowing subsequent pulses to achieve larger lesion sizes with lower peak voltages that avoid SMS
Solution Approach 2:
The patent implements continuity of useful action by delivering multiple pulses in rapid succession with short inter-pulse intervals. The cumulative effect of continuous permeabilization across multiple pulses achieves larger lesion sizes than single pulses, while the brief exposure duration prevents skeletal muscle stimulation
3Productivity
If standard IRE pulse sequences are used, then treatment time is efficient, but unwanted side effects occur
Solution Approach 1:
The patent applies segmentation by dividing the IRE treatment into distinct phases: a preconditioning phase with lower voltage pulses and a main ablation phase with higher voltage pulses. This segmented approach allows each phase to be optimized independently - the preconditioning phase prepares tissue without SMS, and the ablation phase delivers effective treatment
Solution Approach 2:
The patent employs periodic action through the structured alternation of pulse sequences with varying parameters. The rhythmic delivery of preconditioning pulses followed by IRE pulses creates a periodic pattern that systematically builds tissue permeabilization while maintaining safety margins below SMS thresholds
Data Source
AI summary
An electroporation ablation system for treating targeted tissue in a patient. The electroporation ablation system including an ablation catheter and an electroporation generator. The ablation catheter including a handle, a shaft having a distal end, and catheter electrodes situated at the distal end of the shaft and spatially arranged to generate electric fields in the targeted tissue in response to electrical pulses. The electroporation generator operatively coupled to the catheter electrodes and configured to deliver the electrical pulses in an irreversible electroporation pulse sequence that includes a preconditioning pulse sequence and an electroporation pulse sequence to one or more catheter electrodes. Wherein the preconditioning pulse sequence includes preconditioning electrical pulses configured to cause electrolysis near the targeted tissue and tetanizing skeletal muscle stimulation in the patient.