Devices, systems, and methods for real-time monitoring of electrophysical effects during tissue treatment
Inventors
Davalos, Rafael V. • BONAKDAR, MOHAMMAD • LATOUCHE, EDUARDO L. • Mahajan, Roop L. • Robertson, John L. • ARENA, Christopher B. • Sano, Michael B.
Assignees
Virginia Tech Intellectual Properties Inc • Virginia Polytechnic Institute and State University
Publication Number
US-11903690-B2
Publication Date
2024-02-20
Expiration Date
2035-12-15
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Abstract
Provided herein are devices, systems, and methods for monitoring lesion or treated area in a tissue during focal ablation or cell membrane disruption therapy.
Core Innovation
The invention provides devices, systems, and methods for real-time monitoring of electrophysical effects, specifically the formation and progression of lesions or treated areas in tissue during focal ablation or cell membrane disruption therapies. The core components include an electrical conductivity sensor featuring an array of impedance sensors configured to measure both low-frequency (α region) and high-frequency (β region) impedance at specific locations within tissue. These sensors can be integrated with or attached to probes that may be flexible, biocompatible, and optionally feature additional sensing modalities such as temperature, pH, chemical concentrations, or gas measurements.
The problem addressed by the invention is the lack of precise, real-time monitoring techniques for determining the location, size, and progression of lesions or treated areas during clinical procedures like focal ablation or electroporation. Current monitoring approaches—such as bulk impedance measurements or external imaging methods like electrical impedance tomography—either lack spatial specificity, are difficult to implement due to anatomical constraints, or do not provide active, real-time feedback within the tissue being treated. This results in imprecise treatment boundaries and risks to surrounding healthy tissue.
By using an array of localized impedance sensors, the invention enables continuous, real-time measurement and comparison of tissue impedance at different frequencies and locations, allowing for precise detection of the lesion front and its migration. The systems can autonomously adjust or halt therapy in response to these measurements, and can generate 2D/3D images of the treated area, overlaying this information on medical imagery for visualization. The technology can be implemented using flexible substrates, configured arrays, or integrated with treatment probes for improved therapy control and specificity.
Claims Coverage
The patent has three independent claims, each introducing distinct inventive features in sensor construction, probe assembly, and integrated monitoring systems.
Electrical conductivity sensor with dual-frequency impedance array and temperature sensor
An electrical conductivity sensor comprising: - An array of impedance sensors configured to measure impedance at a first frequency (about 0.001 Hz to 1 kHz) and a second frequency (about 0.1 MHz to 100 GHz). - One or more temperature sensors. - A substrate, with the array of impedance sensors and temperature sensors coupled to the substrate. The invention supports integration of additional sensing elements and flexible substrate design.
Electrical conductivity probe with flexible-coupled sensor array and temperature sensing
An electrical conductivity probe comprising: - An elongated member. - An electrical conductivity sensor coupled to a flexible substrate, the flexible substrate in turn coupled to the elongated member. - The electrical conductivity sensor includes an array of impedance sensors configured to measure impedance at both a first frequency (0.001 Hz to 1 kHz) and a second frequency (about 0.1 MHz to 100 GHz), and one or more temperature sensors. Design enables removable coupling at the substrate and multi-point impedance sensing.
Integrated system for tissue monitoring with waveform generator and impedance analysis
A system comprising: - A waveform generator. - An impedance analyzer. - A treatment probe with an elongated member, with: - One or more electrodes configured to deliver electrical energy to tissue. - One or more impedance sensors configured to measure impedance within two frequency ranges (0.001 Hz to 1 kHz and about 0.1 MHz to 100 GHz). - The impedance analyzer communicates with the sensors to measure impedance, and the waveform generator delivers electrical energy to the electrodes and electrical signal to the sensors. The system can include a computer that determines tissue location and generates user signals based on monitored data.
The inventive features focus on localized, frequency-diverse impedance measurement with temperature and additional sensing, flexible and integrated sensor probe construction, and real-time monitoring systems capable of interfacing with therapeutic and diagnostic workflows.
Stated Advantages
Allows real-time, active monitoring of lesion or treated area formation and migration during focal ablation or cell membrane disruption, improving treatment control and specificity.
Enables practitioners to control, adjust, or discontinue treatment in response to migration of the lesion or treated area front, thereby minimizing treatment side effects.
Provides improved specificity for focal ablation and membrane disruption therapies compared to current techniques that rely on bulk impedance measurements or difficult-to-implement imaging methods.
Facilitates autonomous or user-alerted treatment adjustment or cessation based on tissue monitoring, enhancing patient safety and therapeutic efficacy.
Provides capability to generate 3D models or images of the lesion or treated area for overlay on medical images, enhancing visualization and treatment planning.
Documented Applications
Real-time monitoring of lesion formation during focal ablation therapies, including radiofrequency ablation, microwave ablation, laser ablation, cryo-ablation, and ultrasound.
Real-time monitoring of cell membrane disruption procedures, including electroporation (reversible and irreversible), supraporation, and radiation therapy.
Application to tumor ablation and destruction of undesired tissue during clinical treatment.
Monitoring and guiding drug, gene, or nucleic acid delivery to tissue during therapeutic interventions.
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