PEF Ablation Mapping With Electrode Tracking and Field Correlation
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Solution Overview
Problem
Existing tissue ablation procedures, such as radiofrequency ablation, risk collateral damage due to excessive thermal energy application, and there is a need for improved methods to assess and minimize thermal and non-thermal effects in pulsed electric field (PEF) ablation to enhance precision and safety.
Innovation Solution
A medical system utilizing a generator to deliver PEF energy through electrodes, with a tracking system to measure electrode positions and correlate therapeutic effects, visually coding zones of irreversible and reversible electroporation, and displaying these zones on a tissue map to optimize ablation precision.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If radiofrequency ablation is used to heat target tissue, then therapeutic effect is achieved, but collateral damage increases
Solution Approach 1:
The patent changes the energy delivery parameter from continuous thermal energy (RF) to pulsed electric field energy. This fundamental parameter change allows selective electroporation of target cells while minimizing thermal spread to collateral structures, resolving the contradiction between therapeutic efficacy and collateral damage
Solution Approach 2:
The patent employs periodic pulsed electric field delivery rather than continuous energy application. The pulsed nature allows for controlled energy delivery with intervals between pulses, enabling precise temporal control that limits thermal accumulation and collateral heating while maintaining therapeutic electroporation effects
2Reliability
If thermal energy is applied to achieve ablation, then cell death occurs, but temperature control becomes difficult due to tissue movement
Solution Approach 1:
The patent replaces the thermal mechanism (heat diffusion) with an electrical mechanism (electroporation). Electric fields can be precisely controlled and delivered in milliseconds, making the process largely independent of tissue movement and thermal diffusion delays, thus resolving the temperature control difficulty
Solution Approach 2:
The patent applies electric field pulses before significant thermal diffusion can occur. The rapid electroporation action happens on a timescale much faster than thermal conduction, allowing the therapeutic effect to be established before tissue movement and heat spread compromise precision
3Reliability
If successive PEF applications are used to enhance therapeutic effect, then treatment efficacy improves, but temperature rise increases risking collateral damage
Solution Approach 1:
The patent uses periodic pulsed delivery with sufficient intervals between successive applications. This allows thermal dissipation during intervals while maintaining cumulative electroporation effects, resolving the contradiction between enhancing treatment efficacy and limiting temperature rise
Solution Approach 2:
The patent maintains continuous therapeutic action through repeated pulsed applications that build cumulative electroporation effect. The useful action (electroporation) continues across multiple pulses while the harmful thermal effect is limited by the pulsed nature and intervals between applications
4Measurement precision
If real-time measurement of therapeutic effect is implemented, then treatment precision improves, but system complexity increases
Solution Approach 1:
The patent implements feedback by measuring impedance changes that directly correlate with electroporation程度. This simple electrical measurement provides real-time information about therapeutic effect without requiring complex imaging or sensing systems, resolving the contradiction between measurement precision and system complexity
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 precision and safety of PEF ablation by accurately mapping and predicting therapeutic effects, minimizing collateral damage and improving treatment efficacy.
Implementation Method 1
a generator configured to generate pulsed electric field (PEF) energy. A medical device is in electrical communication with the generator and has a plurality of electrodes configured to deliver the generated PEF energy to a target tissue to create electroporated regions in the target tissue
Implementation Method 2
A delivery element tracking system is in communication with the generator and the medical device. The tracking system has processing circuitry configured to: measure a position of at least one of the plurality of electrodes proximate in time to a delivery of PEF energy to the target tissue
Implementation Method 3
The pulsed electric field can be generated with electrical pulses delivered in short bursts. The compromised cell membrane results in the desired cell death and is associated with other measurable phenomena, such as impedance changes resulting from the liberated exchange of ions through the permeabilized cell membranes
Implementation Method 4
The electric field in PEF ablation is established between conductive elements, such as electrodes, and currents flowing through the target tissue, which act as a resistive medium, result in energy dissipation and some temperature rise in the tissue and fluid
Data Source
Figure 1
Figure 2A~2B
Figure 2C~2D
AI summary
A medical system includes a generator configured to generate pulsed electric field (PEF) energy. A medical device is in electrical communication with the generator and has a plurality of electrodes configured to deliver the PEF energy to a target tissue to create electroporated regions in the target tissue. A delivery element tracking system is in communication with the generator and the medical device. The tracking system has processing circuitry configured to: measure a position of at least one of the plurality of electrodes prior to delivery of PEF energy to the target tissue with respect to the target tissue and correlate a PEF field distribution based on the delivery of PEF energy to the target tissue to determine or modify at least one metric of a therapeutic effect from the PEF delivery at positions other than the measured location of the plurality of electrodes.