Ablation Waveform Generator for Muscle-Sparing Biphasic Pulses

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Solution Overview

Problem

Existing ablation therapies, both thermal and non-thermal, struggle to achieve high efficacy and tissue selectivity while avoiding muscle stimulation, particularly with biphasic waveforms that risk muscle stimulation or require paralytics.

Innovation Solution

A device and method utilizing a voltage source, capacitor bank, and output stage with feedback circuits and switch pairs to control electrical ablation, allowing for biphasic waveforms that avoid muscle stimulation by adjusting parameters such as interpulse period and amplitude based on muscle response detection.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If monophasic waveform is used for IRE, then cell death efficacy is improved, but muscle stimulation occurs requiring paralytics

Engineering Contradiction:
Improvecell death efficacyVSAvoidmuscle stimulation
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The single monophasic pulse is segmented into multiple phase components (first phase with first polarity, second phase with second polarity, third phase with first polarity) delivered in sequence. This segmentation allows the waveform to accumulate sufficient charge for effective IRE while interspersing opposite polarity phases that prevent muscle stimulation by canceling out depolarization effects.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The waveform employs periodic alternation between opposite polarities within each pulse cycle. The first phase (first polarity) is followed by a second phase (second polarity), then a third phase (first polarity), creating a periodic structure that delivers cumulative ablation effect while periodically neutralizing muscle stimulation through polarity reversal.

Inventive Principle:
Principle #19Periodic action

2Object-affected harmful factors

If biphasic waveform is used to avoid muscle stimulation, then muscle stimulation is reduced, but ablation efficacy decreases at same energy level

Engineering Contradiction:
Improvemuscle stimulationVSAvoidablation efficacy
Core Design Contradiction:
Object-affected harmful factorsVSReliability

Solution Approach 1:

The waveform parameters are changed from a simple biphasic structure to a multiphasic structure with three distinct phases. The first phase delivers the primary ablation charge, the second phase (with opposite polarity and potentially different duration/amplitude) prevents muscle stimulation, and the third phase (returning to first polarity) supplements the ablation effect. This parameter transformation maintains charge balance for muscle safety while accumulating sufficient total charge for effective IRE.

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The waveform is constructed as a composite of multiple phase components with different characteristics. Each phase contributes differently to the overall effect: the first phase provides initial poration, the second phase provides charge balance and muscle protection, and the third phase provides additional poration. This composite structure achieves both safety and efficacy that neither simple monophasic nor simple biphasic waveforms can achieve alone.

Inventive Principle:
Principle #40Composite materials

3Reliability

If power is increased to make biphasic waveform more effective, then ablation efficacy is improved, but thermal ablation risk increases

Engineering Contradiction:
Improveablation efficacyVSAvoidthermal ablation risk
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The periodic alternation between opposite polarity phases prevents sustained current flow in one direction that would generate heat through resistive heating. By rapidly switching polarities within the pulse train, the waveform delivers cumulative electroporation effects while the alternating directions cancel out thermal accumulation, allowing higher effective doses without thermal damage risk.

Inventive Principle:
Principle #19Periodic action

Solution Approach 2:

The potential harmful effect of high power delivery is converted into a benefit through the multiphasic structure. The opposite polarity phases, which could be seen as reducing net charge delivery, actually prevent thermal accumulation by reversing current direction before significant heat can build up. This transforms what would be a thermal hazard into a safety feature that enables higher effective dosing.

Inventive Principle:
Principle #22Blessing in disguise (Convert harm into benefit)

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 effective ablation therapy with high selectivity and minimal muscle stimulation, mimicking monophasic efficacy without requiring paralytics, by dynamically adjusting waveform parameters to prevent muscle response.

Implementation Method 1

a capacitor bank having at least a first capacitor and one or more additional capacitors

Methodology Applied
Scientific EffectCapacitance: Capacitance

Implementation Method 2

an output stage coupling the capacitor bank to a plurality of output nodes, the output stage comprising: a power selector switch pair coupled to the capacitor stack

Methodology Applied
Scientific EffectElectrical conduction: Conduction (electrical)

Implementation Method 3

Electroporation refers to a phenomenon in which the plasma membrane of a cell exposed to high voltage pulsed electric fields becomes temporarily permeable due to destabilization of the lipid bilayer

Methodology Applied
Scientific EffectElectroporation:

Implementation Method 4

A device and method utilizing a voltage source, capacitor bank, and output stage with feedback circuits and switch pairs to control electrical ablation, allowing for biphasic waveforms that avoid muscle stimulation by adjusting parameters such as interpulse period and amplitude based on muscle response detection

Methodology Applied
Scientific EffectElectrical signal detection:

Data Source

PatentUS12558144B2Waveform generator and control for selective cell ablation
Publication Date: 2026.02.24 BOSTON SCIENTIFIC SCIMED INC
  • US12558144B2 patent drawing
  • US12558144B2 patent drawing
  • US12558144B2 patent drawing

AI summary

Methods and devices for performing ablation. In some examples an ablation delivery system is configured to allow separate voltage levels of a capacitor stack to be accessed for use in therapy delivery. Ablation therapy systems switchable between current and voltage controlled output are described. Methods of treating a patient using adjustable interphase or interpulse delay are disclosed as well.