Electroporation Waveform Segmentation for Microbubble Reduction

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Solution Overview

Problem

Existing tissue ablation systems using electroporation therapy face challenges in reducing microbubble formation, which is undesirable during procedures like pulmonary vein isolation.

Innovation Solution

The system employs a catheter with multiple electrodes and a pulse generator that produces a specific waveform consisting of bursts with loops of pulses, each pulse being 3 microseconds or less in width, to minimize microbubble formation.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If conventional electroporation waveforms are used, then electroporation therapy can be delivered, but microbubble formation increases

Engineering Contradiction:
Improveelectroporation therapy deliveryVSAvoidmicrobubble formation
Core Design Contradiction:
ReliabilityVSObject-generated harmful factors

Solution Approach 1:

The waveform is segmented into multiple bursts, with each burst containing multiple loops of pulses. This segmentation allows the therapy to be delivered in controlled intervals, reducing microbubble formation while maintaining electroporation effectiveness. The pulse train is divided into discrete bursts separated by intervals, preventing continuous microbubble generation.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The waveform employs periodic action through repeated loops of pulses within each burst, with bursts separated by intervals. This periodic structure allows the tissue to recover between bursts while maintaining cumulative electroporation effect. The periodic pulsing pattern reduces microbubble formation compared to continuous waveforms.

Inventive Principle:
Principle #19Periodic action

2Reliability

If higher voltage pulses are used, then electroporation effect is enhanced, but thermal heating increases

Engineering Contradiction:
Improveelectroporation effectVSAvoidthermal heating
Core Design Contradiction:
ReliabilityVSTemperature

Solution Approach 1:

The periodic waveform structure with bursts separated by intervals allows heat to dissipate between bursts, preventing cumulative thermal heating. The electroporation effect is maintained through the periodic pulsing, while the intervals between bursts prevent temperature buildup that would occur with continuous high-voltage application.

Inventive Principle:
Principle #19Periodic action

Solution Approach 2:

The waveform parameters (pulse width, burst duration, interval between bursts) are optimized to deliver sufficient electroporation effect while minimizing thermal heating. By adjusting these parameters, the therapy achieves the necessary electroporation effect without excessive temperature rise.

Inventive Principle:
Principle #35Parameter changes

3Reliability

If longer pulse widths are used, then electroporation effect is improved, but skeletal muscle recruitment increases

Engineering Contradiction:
Improveelectroporation effectVSAvoidskeletal muscle recruitment
Core Design Contradiction:
ReliabilityVSObject-generated harmful factors

Solution Approach 1:

The pulse train is segmented into multiple bursts with intervals between them. This segmentation allows the use of shorter pulse widths within each burst that are effective for electroporation but too short to trigger skeletal muscle recruitment. The cumulative effect of multiple bursts achieves the necessary electroporation without muscle recruitment.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The pulse width parameter is optimized to a specific range that provides sufficient electroporation effect while remaining below the threshold for skeletal muscle recruitment. The waveform parameters are adjusted to achieve the desired electroporation effect without causing muscle contractions.

Inventive Principle:
Principle #35Parameter changes

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

This approach effectively reduces microbubble formation, allowing for more controlled and efficient electroporation therapy with reduced thermal heating and skeletal muscle recruitment.

Implementation Method 1

Electroporation is a substantially non-thermal ablation technique that involves applying strong electric-fields that induce pore formation in the cellular membrane. The electric field may be induced by applying a relatively short duration pulse

Methodology Applied
Scientific EffectElectroporation: Electric Field

Implementation Method 2

Microbubble formation may be attributable to, for example, a combination of electrolysis and gas displacement due to shock waves

Methodology Applied
Scientific EffectElectrolysis: Electrolysis

Implementation Method 3

The ablation catheter imparts ablative energy (e.g., radiofrequency energy, cryoablation, lasers, chemicals, high-intensity focused ultrasound, etc.) to cardiac tissue to create a lesion

Methodology Applied
Scientific EffectRadiofrequency heating: Joule Heating

Data Source

PatentUS20250134571A1Systems and methods for reducing microbubbles in electroporation applications
Publication Date: 2025.05.01 ST JUDE MEDICAL CARDILOGY DIV INC
  • US20250134571A1 patent drawing
  • US20250134571A1 patent drawing
  • US20250134571A1 patent drawing

AI summary

An electroporation system is provided. The electroporation system includes a catheter comprising a plurality of electrodes, and a pulse generator coupled to the catheter, the pulse generator configured to generate a waveform to be delivered using at least one of the plurality of electrodes. The waveform includes a plurality of bursts, each burst including a plurality of loops, and each loop including a plurality of pulses, wherein each of the plurality of pulses has a pulse width of 3 microseconds (μs) or less, wherein each burst includes no more than ten loops, wherein the plurality of bursts include at least ten bursts, and wherein the pulse widths, number of loops per burst, and number of bursts facilitate reducing microbubble formation.