Normalized Current Analysis for Irreversible Electroporation Treatment Planning
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Solution Overview
Problem
Current methods for analyzing tissue ablation in irreversible electroporation (IRE) and high-frequency IRE (H-FIRE) procedures are invasive, expensive, and prone to interference with the electrical field, making it difficult to accurately determine the extent of tissue ablation and compare treatment outcomes across clinicians and clinics.
Innovation Solution
A system that normalizes current responses during IRE or H-FIRE treatments using a processor and sensor system, allowing for comparison of treatment plans and protocols, and includes a database for sharing treatment data, enabling clinicians to predict treatment outcomes and adjust parameters in real-time.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If conventional tools (in situ electrical conductivity measurements, fluroptic or thermocouple based temperature measurements, MRI guided temperature mapping, ultrasound, computer tomography) are used to analyze tissue ablation, then measurement capability is provided, but the tools are invasive, expensive, and interfere with the electrical field used to cause cell death
Solution Approach 1:
The patent uses normalized current measurements as an intermediary parameter to indirectly assess tissue ablation status without directly interfering with the electrical field. Instead of using invasive sensors or imaging tools that perturb the field, the system analyzes current output characteristics (normalized current, rate of change, percentage change) that reflect tissue state changes during IRE/H-FIRE treatment.
Solution Approach 2:
The patent replaces mechanical/invasive measurement systems (electrical conductivity sensors, thermocouples, MRI, ultrasound, CT) with an electrical measurement approach that analyzes current output characteristics. This substitution eliminates the need for physical sensors within the treatment field while providing comparable ablation assessment capability.
2Measurement precision
If conventional tools are used to determine extent of tissue ablation, then measurement is possible, but data post processing is required and the tools are expensive
Solution Approach 1:
The patent extracts and normalizes key current characteristics (current output, rate of change, percentage change) from the raw electrical signals during treatment. By isolating these critical parameters and presenting them in a normalized format, the system eliminates the need for complex post-processing of raw data from multiple sensors or imaging modalities.
Solution Approach 2:
The system performs self-service by automatically normalizing current measurements and providing real-time feedback during treatment. The normalized current calculations and treatment guidance are generated autonomously by the system itself, eliminating the need for external post-processing operations or complex data analysis pipelines.
3Productivity
If current output is used to monitor treatment progress, then real-time feedback is available, but it is difficult to compare different treatments across clinicians and clinics due to numerous variables
Solution Approach 1:
The patent transforms raw current output measurements into normalized current values by adjusting for voltage, electrode configuration, and other treatment-specific parameters. This parameter transformation creates a standardized metric that can be consistently compared across different treatments, clinicians, and clinics while maintaining real-time monitoring capability.
Solution Approach 2:
The normalization process creates equipotentiality in data comparison by equalizing the impact of varying treatment parameters across different clinics. By expressing all current measurements in a standardized normalized format, the system eliminates disparities caused by different voltage levels, electrode configurations, and protocol variations, enabling direct comparison.
4Power
If voltage is increased to improve ablation effectiveness, then treatment intensity increases, but overcurrent occurs especially at higher voltages
Solution Approach 1:
The system continuously monitors normalized current and its rate of change during treatment, providing real-time feedback on tissue response. This feedback mechanism enables the system to detect when voltage increases are causing excessive current changes or when treatment thresholds are approaching, allowing for dynamic adjustment to prevent overcurrent while maintaining effective ablation.
Solution Approach 2:
The patent implements dynamic monitoring and adjustment of treatment parameters based on real-time normalized current measurements. Rather than using static voltage settings, the system dynamically adapts voltage delivery in response to observed tissue response, optimizing ablation effectiveness while preventing overcurrent through continuous parameter adjustment.
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 simplifies the analysis of ablation volume by accounting for intrinsic and extrinsic factors, enabling more precise treatment planning, reducing the risk of overcurrent, and facilitating data sharing across clinics, thereby improving the effectiveness and consistency of IRE and H-FIRE treatments.
Implementation Method 1
the sensor arranged to measure a current produced responsive to application of the plurality of electrical pulses to the target tissue
Implementation Method 2
Irreversible electroporation (IRE) and high-frequency IRE (H-FIRE) are interventional oncology techniques, which may trigger a range of different cell death mechanisms thereby ablating the target tissue
Data Source
AI summary
Provided are devices and techniques to compare current across treatment plans as well as between various clinician and/or clinic protocols. Current from an ablation therapy treatment can be measured and normalized to compare the normalized current between ablation therapy treatments. An efficacy of a treatment, a real-time display of treatment progression, a completion of a treatment, and/or effective treatment planning can be determined based on a change (or a potential change) in the normalized current. Also provided is a database of treatment results including indications of normalized current from the treatments.