Impedance-Based Irreversible Electroporation Protocol Adjustment

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Solution Overview

Problem

Invasive ablation techniques using irreversible electroporation (IRE) face challenges in controlling electrical impedance to prevent excessive Joule heating, which can lead to clinical hazards such as steam popping in cardiac tissue.

Innovation Solution

An IRE method and system that measure impedance between electrodes and adjust the IRE protocol by changing pulse width, repetition rate, and number of pulses to maintain a safe impedance threshold, ensuring that the electrical current does not cause overheating, while maintaining the cumulative energy delivery for effective ablation.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Productivity

If IRE pulses are applied with high power to achieve effective ablation, then the ablation efficacy is improved, but the Joule heating increases causing tissue overheating and steam popping

Engineering Contradiction:
Improveablation efficacyVSAvoidJoule heating
Core Design Contradiction:
ProductivityVSObject-affected harmful factors

Solution Approach 1:

The system dynamically adjusts IRE protocol parameters (pulse width, repetition rate, number of pulses) based on real-time impedance measurements. The protocol is not fixed but adapts to changing tissue conditions, allowing optimization of ablation efficacy while preventing excessive Joule heating through continuous monitoring and adjustment.

Inventive Principle:
Principle #15Dynamics

Solution Approach 2:

The system incorporates real-time impedance measurement as feedback to control the IRE pulse delivery. By continuously monitoring impedance changes during the procedure, the system can detect tissue heating trends and adjust protocol parameters accordingly, creating a closed-loop control system that prevents steam popping while maintaining ablation effectiveness.

Inventive Principle:
Principle #23Feedback

2Reliability

If the IRE protocol parameters are adjusted to reduce Joule heating, then the safety is improved, but the cumulative energy delivery decreases reducing ablation efficacy

Engineering Contradiction:
ImprovesafetyVSAvoidablation efficacy
Core Design Contradiction:
ReliabilityVSProductivity

Solution Approach 1:

The system dynamically optimizes protocol parameters based on real-time impedance measurements. When impedance indicates lower risk of overheating, the system can apply longer pulse widths or higher repetition rates to increase cumulative energy delivery. When impedance suggests higher heating risk, the system reduces power density while maintaining total energy delivery through extended treatment duration, thus balancing safety and efficacy.

Inventive Principle:
Principle #15Dynamics

Solution Approach 2:

The system changes multiple protocol parameters simultaneously (pulse width, repetition rate, number of pulses) in coordinated ways to maintain cumulative energy delivery while adjusting power density. For example, when reducing peak power to prevent overheating, the system compensates by increasing pulse duration or number of pulses, keeping the total energy delivered within the range required for effective ablation.

Inventive Principle:
Principle #35Parameter changes

3Reliability

If real-time impedance measurement and adaptive protocol adjustment are implemented, then the safety control is improved, but the device complexity increases

Engineering Contradiction:
Improvesafety controlVSAvoidsystem complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The system performs self-monitoring and self-adjustment through automated impedance measurement and protocol selection algorithms. The device autonomously evaluates tissue conditions and selects appropriate IRE protocols without requiring complex external control systems or manual intervention, reducing overall system complexity while maintaining sophisticated safety control.

Inventive Principle:
Principle #25Self-service

Solution Approach 2:

The system pre-establishes multiple IRE protocols with different parameter combinations before the procedure. During treatment, the system simply measures impedance and selects from pre-defined protocols rather than calculating optimal parameters in real-time, significantly reducing computational complexity while maintaining adaptive safety control.

Inventive Principle:
Principle #10Preliminary action

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 ensures safe and effective IRE ablation by adjusting the protocol based on measured impedance, reducing the risk of excessive heating and maintaining clinical efficacy, thereby enhancing the safety and effectiveness of cardiac IRE procedures.

Implementation Method 1

An impedance is measured between the selected electrodes. Based on the measured impedance, an IRE protocol is chosen

Methodology Applied
Scientific EffectElectrical Impedance: Electrical Resistance

Implementation Method 2

Invasive ablation techniques using irreversible electroporation (IRE) face challenges in controlling electrical impedance to prevent excessive Joule heating

Methodology Applied
Scientific EffectJoule Heating: Joule Heating

Data Source

PatentUS20240335231A1Impedance based irreversible-electroporation (IRE)
Publication Date: 2024.10.10 BIOSENSE WEBSTER (ISRAEL) LTD
  • US20240335231A1 patent drawing
  • US20240335231A1 patent drawing

AI summary

An irreversible electroporation (IRE) method includes selecting electrodes of a catheter placed in contact with tissue in an organ, for applying IRE pulses between the selected electrodes. An impedance is measured between the selected electrodes. Based on the measured impedance, an IRE protocol is chosen, that has parameters that meet a predefined safety criterion under the measured impedance. The IRE pulses are applied according to the chosen protocol.