IRE and H-FIRE Treatment Planning via Normalized Current Monitoring
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Solution Overview
Problem
Current methods for determining the extent of tissue ablation during irreversible electroporation (IRE) and high-frequency IRE (H-FIRE) procedures lack reliability, particularly in assessing the impact of temperature, making it difficult for clinicians to design and plan treatment effectively, and there is no standardized way to compare treatment outcomes across different clinicians and clinics.
Innovation Solution
The system determines the appropriate application of IRE and H-FIRE based on tumor immunoscore and type, using invasive and non-invasive immunomonitoring technologies to classify tumors as 'cold,' 'immunosuppressed,' or 'hot,' and adjusts treatment intensity accordingly, normalizing current responses to compare treatment efficacy and plan further procedures.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If clinicians use thermal ablation techniques to determine extent of ablation, then temperature and exposure time can be used to assess ablation, but this method cannot be reliably applied to IRE or H-FIRE procedures due to lack of temperature impact data
Solution Approach 1:
The patent changes the measurement parameter from temperature (thermal ablation) to current (electrical ablation). By monitoring current changes during IRE/H-FIRE procedures, the system can determine ablation extent without relying on temperature data, which is not reliably captured or interpreted for electrical ablation methods.
Solution Approach 2:
The patent substitutes the thermal measurement system with an electrical measurement system. Instead of using temperature sensors and thermal models to assess ablation, the system uses current measurements and electrical conductivity changes to determine ablation extent, providing a more reliable method for electrical ablation procedures.
2Adaptability or versatility
If treatment protocols are customized for each clinician and clinic, then treatment can be adapted to local needs, but data sharing and comparison between different clinicians and clinics becomes difficult
Solution Approach 1:
The patent standardizes the measurement parameter across all clinics by using normalized current values. This allows treatment data from different clinicians and clinics to be compared and shared effectively, while still allowing customization of treatment protocols based on local needs and patient characteristics.
Solution Approach 2:
The patent creates a universal data format and comparison framework that works across different clinics and treatment protocols. By normalizing current responses and providing standardized treatment planning tools, the system enables both local customization and broad data sharing simultaneously.
3Productivity
If current methods are used to monitor IRE treatment, then treatment can be performed, but the complexity of ablation volume and lack of standardized comparison makes treatment planning difficult
Solution Approach 1:
The patent simplifies the assessment of ablation volume by focusing on current changes rather than attempting to directly measure complex volumetric parameters. By monitoring electrical conductivity changes and normalized current responses, the system provides a simpler, more direct indicator of treatment progress and ablation extent.
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 allows for precise determination of treatment intensity, simplifies the complexity of ablation volume, and enables the creation of databases for sharing treatment protocols, improving the accuracy and consistency of IRE and H-FIRE treatments by normalizing current responses, thus enhancing treatment planning and outcomes.
Implementation Method 1
Irreversible electroporation (IRE) and high-frequency IRE (H-FIRE) are techniques to cause permanent death of tissue cells in a body, thereby ablating the tissue. IRE and H-FIRE are facilitated by application of voltage pulses to tissue to create short but strong electrical fields to form permanent nanopores in cell membranes of the tissue.
Implementation Method 2
the present disclosure provides to compare current across treatment plans as well as between various clinician and/or clinic protocols. In general, the present disclosure provides to normalize the current response from a treatment and compare normalized current between treatments.
Data Source
AI summary
Provided are techniques to compare current across treatment plans as well as between various clinician and/or clinic protocols. Further provided are devices and methods to generate a recommended treatment plan for an ablation modality like IRE or H-FIRE to treat a tumor. 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, or a completion of a treatment, can be determined based on a change in the normalized current. Also provided is a database of treatment results including indications of normalized current from the treatments.