Segmented Electrode Catheter Contact Quality Control

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Solution Overview

Problem

Existing cardiac radiofrequency (RF) and electrophysiological (EP) multi-electrode catheters face challenges in ensuring consistent physical contact between electrodes and tissue during ablation, leading to inefficient and potentially unsafe ablation procedures, as incomplete contact can cause unwanted effects such as clot formation or incomplete tissue isolation.

Innovation Solution

An expandable catheter with multiple electrodes and a processor-controlled switching assembly that determines the quality of electrode-tissue contact by evaluating temperature and impedance criteria, allowing electrodes to switch between ablative power delivery and EP sensing, ensuring effective and safe ablation by reusing electrodes for sensing if contact is insufficient.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of operation

If electrodes are used for ablation without verifying contact quality, then ablation procedure is simplified, but safety and effectiveness deteriorate due to incomplete contact causing clot formation or incomplete tissue isolation

Engineering Contradiction:
Improveablation procedure simplicityVSAvoidablation safety and effectiveness
Core Design Contradiction:
Ease of operationVSReliability

Solution Approach 1:

The system performs preliminary contact quality assessment by measuring impedance and temperature before initiating ablation. This preliminary action ensures that electrodes are properly contacted with tissue, preventing unsafe ablation while maintaining procedural simplicity through automated pre-checks.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The system continuously monitors impedance and temperature during ablation and provides feedback to the control mechanism. When contact quality deteriorates or insufficient contact is detected, the system automatically adjusts or terminates ablation, ensuring safety and effectiveness without requiring complex manual monitoring.

Inventive Principle:
Principle #23Feedback

2Productivity

If electrodes with insufficient contact are used for ablation, then ablation coverage is maintained, but harmful effects increase due to clot formation and incomplete tissue isolation

Engineering Contradiction:
Improveablation coverageVSAvoidclot formation and incomplete tissue isolation
Core Design Contradiction:
ProductivityVSObject-affected harmful factors

Solution Approach 1:

The system uses real-time feedback from impedance and temperature sensors to detect insufficient electrode-tissue contact. When such conditions are identified, the control mechanism automatically adjusts ablation parameters or terminates the procedure, preventing harmful effects while maintaining effective ablation coverage in properly contacted regions.

Inventive Principle:
Principle #23Feedback

Solution Approach 2:

The system applies different ablation strategies to different electrode segments based on their individual contact quality. Electrodes with good contact receive full ablation power, while those with insufficient contact are either adjusted or excluded, ensuring local optimization that prevents harmful effects while maintaining overall ablation coverage.

Inventive Principle:
Principle #3Local quality

3Productivity

If all electrodes are continuously used for ablation, then ablation efficiency is maintained, but electrode lifespan decreases due to wear from repeated switching and potential damage from insufficient contact

Engineering Contradiction:
Improveablation efficiencyVSAvoidelectrode lifespan
Core Design Contradiction:
ProductivityVSDuration of action of stationary object

Solution Approach 1:

The system automatically identifies electrodes with insufficient contact quality and excludes them from further ablation use. These electrodes are recovered from the ablation circuit and can be reused in future procedures after proper positioning, extending their lifespan while maintaining ablation efficiency with the remaining functional electrodes.

Inventive Principle:
Principle #34Discarding and recovering

Solution Approach 2:

The system performs self-diagnosis of electrode contact quality and automatically manages electrode allocation without external intervention. This self-service capability ensures continuous ablation efficiency while protecting electrodes from damage through automated monitoring and selective deactivation of problematic electrodes.

Inventive Principle:
Principle #25Self-service

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 enhances the safety and effectiveness of cardiac ablation treatments by ensuring optimal electrode-tissue contact, reducing unwanted effects and improving clinical outcomes for procedures like pulmonary vein isolation.

Implementation Method 1

The processor is configured to determine whether the physical contact of the electrode meets the predefined contact quality, by evaluating a preset temperature criterion. In other exemplary embodiments, the processor is configured to evaluate the preset temperature criterion by evaluating a relation of a measured temperature of the electrode to a preset threshold temperature.

Methodology Applied
Scientific EffectTemperature sensing:

Implementation Method 2

the processor is configured to determine whether the physical contact of the electrode meets the predefined contact quality, by evaluating a preset impedance criterion. In another exemplary embodiment, the processor is configured to evaluate the impedance criterion by assessing whether a frequency-dependence of the impedance indicates that the electrode contacts blood or indicates that the electrode contacts tissue.

Methodology Applied
Scientific EffectImpedance measurement: Electrical Resistance

Implementation Method 3

The electrode is adapted to be connected to a source of ablation energy to conduct ablation energy for transmission by the electrode into tissue at the tissue-electrode interface.

Methodology Applied
Scientific EffectRadiofrequency heating: Dielectric Heating

Implementation Method 4

The electrode is adapted to be connected to a source of ablation energy to conduct ablation energy for transmission by the electrode into tissue at the tissue-electrode interface.

Methodology Applied
Scientific EffectJoule heating: Joule Heating

Implementation Method 5

The systems and methods also include an element to cool the electrode.

Methodology Applied
Scientific EffectThermal conduction: Conduction (thermal)

Data Source

PatentUS12114918B2Dynamic ablation and sensing according to contact of segmented electrodes
Publication Date: 2024.10.15 BIOSENSE WEBSTER (ISRAEL) LTD
  • US12114918B2 patent drawing
  • US12114918B2 patent drawing
  • US12114918B2 patent drawing

AI summary

A system includes an expandable distal end of a catheter and a processor. The expandable distal end has multiple electrodes that are configured to be placed in contact with a tissue in an organ and to apply ablative power to tissue. The processor is configured to, during application of the ablative power, determine whether a physical contact between the electrodes and tissue meets a predefined contact quality, and, if the physical contact of an electrode among the electrodes with the tissue does not meet the predefined contact quality, re-use the electrode for electrophysiological (EP) sensing.