Biphasic Pulse Generation for Non-Thermal Soft Tissue Ablation
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Solution Overview
Problem
Existing thermal-based soft tissue ablation modalities, such as radiofrequency and cryoablation, often cause collateral damage and tissue necrosis, necessitating the development of more tissue-selective and minimally invasive ablation methods.
Innovation Solution
The use of pulsed field ablation systems and waveforms, including high voltage biphasic pulses with varying inter-phase and pulse-to-pulse delays, delivered through electrodes on minimally invasive devices for precise tissue ablation, minimizing collateral damage and enabling rapid healing.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If thermal-based ablation modalities (radiofrequency, cryoablation) are used, then tissue ablation is achieved, but collateral damage and tissue necrosis occur
Solution Approach 1:
The patent transitions from thermal parameters (temperature, heat flux) to non-thermal electrical parameters (voltage, pulse duration, frequency) to achieve tissue ablation. By changing the fundamental physical parameter from thermal to electrical, the method eliminates collateral thermal damage while maintaining ablation effectiveness through irreversible electroporation of target cells
Solution Approach 2:
The patent replaces thermal-based mechanical/physical ablation systems with electrical field-based pulsed field ablation systems. This substitution uses high-voltage electrical pulses to create transmembrane voltage in target cells, causing irreversible electroporation and cell death without the thermal diffusion that causes collateral damage in traditional methods
2Productivity
If high voltage pulsed waveforms are delivered for rapid tissue ablation, then ablation efficiency increases, but device complexity increases
Solution Approach 1:
The patent divides the ablation process into discrete high-voltage pulsed waveforms with specific parameters (voltage amplitude, pulse width, frequency, duty cycle). By segmenting the continuous thermal energy delivery into controlled electrical pulses, the system achieves rapid ablation while allowing precise control over the ablation zone, thereby managing device complexity through parameterization
Solution Approach 2:
The patent employs periodic high-voltage pulsed waveforms delivered at controlled frequencies and duty cycles to achieve cumulative electroporation effect in target tissues. This periodic electrical action allows rapid ablation through multiple pulses while the intervals between pulses prevent thermal accumulation, maintaining tissue integrity and managing device complexity through temporal control
3Object-affected harmful factors
If pulsed field ablation is used to minimize collateral damage, then tissue selectivity improves, but treatment duration may increase
Solution Approach 1:
The patent delivers continuous trains of high-voltage electrical pulses without interruption to achieve cumulative electroporation effect in target tissues. This continuous pulsed action ensures complete ablation of the target zone while the non-thermal mechanism prevents collateral damage, achieving both tissue selectivity and procedural efficiency simultaneously
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
Pulsed field ablation achieves efficient and rapid tissue ablation with minimal side effects, preserving tissue integrity and allowing for quick post-procedural healing.
Implementation Method 1
Pulsed field ablation, also known as irreversible electroporation, has emerged as a potentially useful ablation modality
Implementation Method 2
the generation of high voltage pulsed waveforms delivered to electrodes disposed near tissue for the rapid and efficient ablation of tissue
Data Source
AI summary
Systems, devices, and methods described herein relate to generation and delivery of pulsed waveforms, e.g., for therapy delivery in soft tissue ablation procedures. In some embodiments, a pulse generator is configured to generate a voltage pulse train including a plurality of biphasic pulses, each biphasic pulse of the plurality of biphasic pulses including a positive pulse, a negative pulse, and an inter-phase delay separating the positive pulse and the negative pulse. In some embodiments, successive biphasic pulses of the plurality of biphasic pulses can be separated by a pulse-to-pulse delay such that the plurality of biphasic pulses is separated by a plurality of pulse-to-pulse delays, and the plurality of pulse-to-pulse delays can include increasing or decreasing sequences of pulse-to-pulse delays.