Biphasic Pulsed-Field Cardiac Ablation With Reduced Collateral Damage
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Solution Overview
Problem
Existing cardiac ablation techniques, particularly those using radiofrequency (RF) energy, face challenges such as collateral damage to non-target tissues, extended treatment times, and potential for embolic events due to tissue charring, with RF energy application proximity to structures like the esophagus or phrenic nerve.
Innovation Solution
A system employing pulsed-field ablation with a generator delivering biphasic pulses of specific parameters, including inter-pulse and inter-phase delays, voltage, and frequency, controlled by ECG electrodes to target cardiac tissue, minimizing collateral effects and reducing treatment time.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If RF energy is applied to ablate cardiac tissue, then arrhythmia treatment is achieved, but collateral damage to non-target tissue occurs
Solution Approach 1:
The patent changes the energy delivery parameters from continuous RF energy to pulsed electric fields with specific characteristics (pulse width 1-5μs, frequency 1kHz, voltage 300-4000V). This parameter change enables selective ablation of cardiac tissue while minimizing thermal spread to adjacent structures like the esophagus and phrenic nerve, thus resolving the contradiction between treatment efficacy and collateral damage.
Solution Approach 2:
The patent employs periodic pulsed energy delivery instead of continuous RF energy. The pulsed field ablation delivers energy in controlled bursts (at least 60 pulses per train, with inter-pulse delays of at least 5μs), creating localized lesions without sustained thermal exposure to surrounding tissues. This periodic action achieves reliable arrhythmia treatment while protecting non-target structures.
2Reliability
If RF energy is applied for extended periods to ensure complete ablation, then arrhythmia correction is achieved, but treatment time increases
Solution Approach 1:
The patent delivers multiple pulse trains (at least 60 pulses per train, four trains per site) in rapid succession with minimal interruption. This continuous pulsed energy delivery ensures complete and reliable ablation of arrhythmogenic tissue without requiring extended treatment periods, as each pulse train contributes to cumulative lesion formation.
Solution Approach 2:
By changing from continuous RF energy to high-voltage pulsed fields with microsecond durations, the patent achieves more efficient energy deposition per unit time. The specific parameters (voltage 300-4000V, pulse width 1-5μs, frequency 1kHz) enable rapid tissue ablation, reducing overall treatment time while maintaining complete arrhythmia correction.
3Reliability
If RF energy is applied for extended periods, then complete ablation is achieved, but tissue charring and embolic events increase
Solution Approach 1:
The pulsed energy delivery allows brief intervals between pulses for heat dissipation, preventing cumulative thermal effects that cause charring. The periodic pulsed fields (with inter-pulse delays of at least 5μs) achieve complete ablation through repeated stress cycles rather than sustained heating, eliminating the harmful effect of tissue carbonization and reducing embolic risk.
Solution Approach 2:
The patent replaces the thermal mechanism of RF ablation with a non-thermal pulsed electric field mechanism. Instead of relying on continuous heating that causes charring, the pulsed fields induce electroporation and mechanical stress in tissue, achieving complete ablation without thermal degradation products that could embolize.
4Manufacturing precision
If higher energy is applied to create deeper lesions, then ablation effectiveness is improved, but collateral damage to surrounding structures increases
Solution Approach 1:
The pulsed electric fields create highly localized energy deposition at the electrode-tissue interface, producing deep lesions precisely where needed. The electric field concentration at the tissue surface enables controlled lesion depth adjustment without increasing energy spread to adjacent structures, achieving both deep penetration and spatial precision.
Solution Approach 2:
By adjusting pulsed field parameters (voltage amplitude, pulse width, frequency, and number of pulses), the patent enables independent control of lesion depth and geometry. Higher voltages (300-4000V) create deeper lesions, while the pulsed nature and short duration prevent lateral thermal spread, thus improving ablation effectiveness without increasing collateral damage.
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 pulsed-field ablation system effectively creates precise, deeper lesions with reduced collateral damage and shorter treatment duration, minimizing risks to non-target tissues and avoiding muscle stimulation.
Implementation Method 1
a medical system, including a medical device having a plurality of deployable arms, and at least one electrode on at least one of the plurality of deployable arms; and an electric signal generator in communication with the medical device, the electric signal generator programmed to deliver pulsed energy to the medical device to ablate cardiac tissue
Implementation Method 2
The pulse train includes at least 60 pulses, an inter-phase delay between 0μs and 5μs, an inter-pulse delay of at least 5μs, and a pulse width between 1 and 5μs
Data Source
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Figure 3~4
AI summary
A method for ablating tissue by applying at least one pulse train of pulsed-field A system (10) for ablating cardiac tissue, the system (10) comprising: a generator (14) configured to deliver at least one pulse train of energy at a predetermined frequency, the pulse train of energy including biphasic pulses, the generator (14) being configured to deliver the biphasic pulses at a plurality of voltage amplitudes (A); and a medical device (12) in electrical communication with the generator (14), the medical device (12) having a plurality of electrodes (24), each electrode (24) configured to have a polarity that is different than each adjacent electrode (24) and configured to deliver the at least one pulse train of energy in bipolar mode from the plurality of electrodes (24).