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
Engineering 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
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
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
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
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
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
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
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
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
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
Data Source
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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.