Pulsed Electric Field Generator for Closed-Loop Tissue Ablation
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Solution Overview
Problem
Existing electroporation technologies lack precise control over high voltage application for tissue selectivity and safety, particularly in ablation therapy for cardiac arrhythmias, necessitating improved measurement and control schemes for energy delivery.
Innovation Solution
A system with a multi-channel voltage/signal generator and programmable controller for adaptive adjustment of waveform amplitude, using current measurement and resistor modulation to ensure controlled energy delivery, and hierarchical pulse waveforms synchronized with cardiac pacing to minimize tissue damage.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Manufacturing precision
If high voltage pulses are applied to tissue for ablation therapy, then tissue selectivity and ablation effectiveness are improved, but safety and control over energy delivery deteriorate
Solution Approach 1:
The system measures the actual current delivered to tissue and uses this feedback to dynamically adjust subsequent voltage pulses. The controller monitors tissue impedance changes and adapts the waveform in real-time, ensuring safe energy delivery while maintaining effective ablation. This closed-loop control prevents excessive energy delivery that could compromise safety.
Solution Approach 2:
The patent implements dynamic adjustment of voltage waveform parameters including amplitude, duration, and inter-pulse intervals based on real-time tissue response. The system transitions from static pre-programmed pulses to adaptive waveforms that evolve during the procedure, optimizing both selectivity and safety throughout the ablation process.
2Manufacturing precision
If high voltage pulses are applied to tissue for ablation therapy, then ablation effectiveness is improved, but control over energy delivery deteriorates
Solution Approach 1:
Real-time current measurement and impedance monitoring provide feedback that enables automatic adjustment of energy delivery parameters. The system self-regulates based on tissue conditions, making complex high-voltage delivery controllable through automated algorithms rather than manual adjustment.
Solution Approach 2:
The patent replaces manual control mechanisms with automated electronic control systems that use algorithms to determine optimal pulse parameters. The controller automatically adjusts voltage, current, and timing based on measured tissue properties, substituting complex mechanical adjustment procedures with intelligent electronic control.
3Measurement precision
If voltage output is dynamically adjusted during pulse delivery, then energy delivery precision is improved, but device complexity increases
Solution Approach 1:
The system uses a single integrated controller that performs multiple functions: generating voltage pulses, measuring current, calculating impedance, and adjusting waveform parameters. This multi-functional approach achieves precise energy delivery without proportionally increasing device complexity, as one component handles diverse control tasks.
Solution Approach 2:
The patent combines the voltage generation, current measurement, and waveform control functions into an integrated system architecture. By merging these functions into a coordinated control framework, the system achieves precise energy delivery while minimizing the complexity increase that would result from separate independent control systems.
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
Enhances the safety and effectiveness of energy delivery by reducing the electric field threshold for irreversible electroporation, allowing precise ablation with minimized healthy tissue damage and reduced total energy use.
Implementation Method 1
Application of brief, high DC voltages to tissue may generate locally high electric fields typically in the range of hundreds of volts per centimeter that disrupt cell membranes by generating pores in the cell membrane. Such electroporation may be irreversible if the applied electric field at the membrane is larger than a threshold value, leading to the pores remaining open, thereby leading to necrosis and/or apoptosis (cell death).
Data Source
AI summary
Systems, devices, and methods for current control of energy delivery to ablate tissue are disclosed. A generator may include a set of electrode channels coupled to a set of electrodes during use. Each electrode channel from the set of electrode channels may include a first switch from a first set of switches and a second switch from a second set of switches. A set of energy sources may be coupled to a third set of switches. The third set of switches may be configured to switch from an OFF state to an ON state to couple the set of energy sources to the set of electrodes. A set of resistors may be coupled to the second set of switches. The second set of switches may be configured to switch from an OFF state to an ON state to couple the set of resistors to the set of electrodes.