Cardiac Ablation Catheter Using Biphasic Electroporation Waveforms

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Solution Overview

Problem

Current cardiac ablation methods for treating atrial fibrillation are time-consuming and inefficient, particularly for persistent AF patients, as they require precise manipulation of catheters to create consistent lesions, and existing energy sources like RF, cryo, and laser systems have limitations in effectively treating all patients.

Innovation Solution

The method employs electroporation by applying an electrical potential across cardiac cells using a plurality of electrodes within an applicator to rupture cell membranes, forming lesions, which can be controlled to create linear or multiple lesions efficiently, synchronized with the heart's natural beat, using a biphasic, truncated waveform to optimize energy delivery.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If radio frequency energy is applied via catheter tip to create lesions by heating tissue, then lesions can be created to prevent AF, but the procedure becomes time-consuming (2-4 hours) and highly dependent on operator skill

Engineering Contradiction:
Improvelesion creation effectivenessVSAvoidprocedure duration
Core Design Contradiction:
ReliabilityVSLoss of time

Solution Approach 1:

The catheter is divided into multiple ring electrodes along its length, allowing simultaneous or sequential application of RF energy at multiple positions along the catheter rather than requiring sequential tip-based applications. This segmentation enables parallel lesion creation, dramatically reducing procedure time while maintaining reliable lesion formation through controlled energy delivery at each electrode position

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The manual manipulation of the catheter tip to create spot lesions is replaced by a controlled electrical energy delivery system through multiple electrodes. The mechanical skill-dependent process of positioning and creating overlapping burn spots is substituted with an electrical system that can deliver energy along the entire catheter length, reducing operator skill dependency and procedure time

Inventive Principle:
Principle #28Mechanics substitution (Replace mechanical system)

2Productivity

If linear ablation catheters are used to deliver RF along the edge of the catheter, then linear lesions can be created faster, but consistent contact with tissue along the catheter length is difficult to maintain

Engineering Contradiction:
Improvelesion creation speedVSAvoidlesion consistency
Core Design Contradiction:
ProductivityVSManufacturing precision

Solution Approach 1:

Temperature sensors (thermistors or thermocouples) are integrated at each ring electrode position to provide real-time feedback on tissue temperature during RF delivery. This feedback enables closed-loop control of the RF energy at each electrode, ensuring consistent lesion formation even when catheter-tissue contact varies. The system automatically adjusts energy delivery based on measured temperature, maintaining precision without requiring perfect mechanical contact

Inventive Principle:
Principle #23Feedback

Solution Approach 2:

The system dynamically adjusts RF energy delivery at each electrode based on real-time temperature measurements and tissue response. Rather than delivering static energy levels, the system modulates power to each ring electrode independently based on feedback, allowing adaptation to varying contact conditions while maintaining consistent linear lesion formation throughout the catheter length

Inventive Principle:
Principle #15Dynamics

3Reliability

If cryo or laser energy systems are used to ablate around pulmonary vein ostia, then lesions can be created around PVs to terminate AF, but these systems are not effectively used successfully in persistent AF patients

Engineering Contradiction:
ImproveAF termination success for paroxysmal AFVSAvoideffectiveness across different AF types
Core Design Contradiction:
ReliabilityVSAdaptability or versatility

Solution Approach 1:

The RF ablation catheter with multiple ring electrodes is designed to create linear lesions that can address both focal sites around pulmonary vein ostia and broader atrial tissue involved in persistent AF. The system can deliver energy patterns suitable for PV isolation while also creating extended linear lesions in other atrial regions, making it universally applicable to both paroxysmal and persistent AF mechanisms

Inventive Principle:
Principle #6Universality (Multi-functionality)

Solution Approach 2:

The system allows adjustment of RF energy parameters (power, duration, pulse patterns) at each electrode to adapt to different tissue types and AF mechanisms. By modifying electrical parameters rather than being constrained to fixed thermal or mechanical ablation parameters, the system can effectively treat both the focal pathology of paroxysmal AF and the more diffuse changes in persistent AF tissue

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 allows for precise and efficient creation of lesions, potentially reducing procedure time and improving success rates for both paroxysmal and persistent AF treatments by utilizing energy-efficient electroporation, enhancing control over heart tissue ablation.

Implementation Method 1

supply an electrical potential across cells within one or more areas of tissue within the heart; wherein the electrical potential supplied across the cells acts to rupture said cells to form a lesion within the tissue

Methodology Applied
Scientific EffectElectroporation:

Data Source

PatentEP3463134B1Apparatus for cardiac ablation
Publication Date: 2022.07.20 DOT MEDICAL LTD
  • EP3463134B1 patent drawingFigure 1~2
  • EP3463134B1 patent drawingFigure 3~4
  • EP3463134B1 patent drawing

AI summary

The invention comprises an apparatus for performing cardiac ablation by electroporation comprising: an applicator comprising a plurality of electrodes (16) each operable in use to supply an electrical potential across cells within an area of tissue (12); and a means to control the waveform of the electrical potential supplied by the plurality of electrodes, configured to provide a biphasic, truncated waveform with leading and trailing edges of differing magnitude.