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-10694972-B2
Publication Date
2020-06-30
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. Provided herein are embodiments of an electrical conductivity sensor having an impedance sensor, where the impedance sensor can be configured to measure a low-frequency and a high-frequency impedance and a substrate, where the impedance sensor is coupled to the substrate. The substrate can be flexible. In embodiments, the impedance sensor can contain two or more electrical conductors. The electrical conductors can be in a bipolar configuration. The electrical conductors can be in a tetrapolar configuration. In embodiments, the electrical conductivity sensor can have two impedance sensors that can be coupled to the substrate such that they are orthogonal to each other.
Core Innovation
The invention provides devices, systems, and methods for real-time monitoring of lesions or treated areas in tissue during focal ablation or cell membrane disruption therapy. The solution features an electrical conductivity sensor that includes an impedance sensor capable of measuring both low-frequency and high-frequency impedance, coupled to a substrate which can be flexible. The impedance sensor may include two or more electrical conductors configured in either a bipolar or tetrapolar arrangement, and can be organized in arrays or in orthogonal orientations to improve spatial resolution.
A key problem addressed is the lack of specificity in current monitoring methods for focal ablation or membrane disruption procedures, which rely on bulk tissue properties and often fail to pinpoint the spatial location of the lesion or treated area front. Traditional solutions like electrical impedance tomography require complicated external electrode array placement and often suffer from limited resolution due to anatomical constraints and electrode positioning difficulties. There is therefore a need for improved techniques that allow real-time and specific monitoring of treatment progression within targeted tissues.
The described invention overcomes these limitations by using an impedance sensor, and optionally a sensor array, to measure changes in impedance or other tissue characteristics (such as pH, temperature, or chemical concentrations) at well-defined points within the tissue. This enables precise detection of the lesion or treated area front's position and monitoring of its growth during therapy. The added capability of continuous real-time measurement allows practitioners to receive alerts when predetermined treatment boundaries are reached, or to enable automatic adjustment or cessation of treatment based on sensor feedback.
Claims Coverage
The patent includes two independent claim structures: one for a system and one for a method, each covering several inventive features related to real-time electrical monitoring of tissue during ablation or membrane disruption.
System for real-time monitoring of tissue impedance during ablation or membrane disruption
The system comprises: - An electrical conductivity probe with an elongated member and a removably coupled electrical conductivity sensor, where the sensor includes an impedance sensor capable of measuring both low-frequency and high-frequency impedance. - A substrate to which the impedance sensor is coupled. - A treatment probe configured to deliver energy sufficient to disrupt a cell membrane. - An impedance analyzer connected to the electrical conductivity probe. - A low voltage power supply for delivering low voltage energy to the probe. - A waveform generator connected to the low voltage power supply. - A gate driver connected to the waveform generator and low voltage power supply. - A high voltage switch connecting the treatment probe and impedance analyzer. - A high voltage power supply connected to the high voltage switch.
Computer-enabled determination and feedback of lesion or treated area
The system can further include a computer connected to the impedance analyzer, the computer comprising processing logic configured to: - Determine the position of a lesion or treated area front within tissue undergoing focal ablation or cell membrane disruption therapy. - Generate a signal to a user when the lesion or treated area front reaches a predetermined position. - Automatically manipulate the system to adjust or stop treatment when the lesion or treated area front has reached a predetermined location.
Method for monitoring lesion or treated area front or size during therapy
The method includes: 1. Inserting the electrical conductivity probe and the treatment probe into tissue. 2. Applying treatment by delivering energy through the treatment probe. 3. Continuously measuring a tissue characteristic (such as impedance, pH, temperature, gas concentration, chemical concentration, nucleic acid concentration, or combinations thereof) during the treatment. 4. Detecting changes in the tissue characteristic. 5. Using an impedance sensor array with two or more impedance sensors, and determining the lesion or treated area front or size by comparing data between the sensors. - The method may include stopping or adjusting treatment, or alerting a user, when a change or a threshold is detected. - Calculating lesion size based on changes in impedance measurements. - Overlaying computed 2D/3D lesion or treated area geometry on medical images and visualizing migration or growth via image overlay.
In summary, the inventive features center on a system and method integrating a specialized impedance-sensing probe, real-time electronics, and computer-based logic to enable direct, real-time monitoring and control of tissue ablation or disruption therapies. The system achieves high specificity by measuring at defined internal points within the tissue and integrates automated feedback or control functions.
Stated Advantages
Provides improved specificity in monitoring lesion/treated area during focal ablation or cell membrane disruption procedures compared to existing bulk impedance measurement techniques.
Enables real-time detection and precise spatial localization of lesion or treated area front, supporting dynamic control and adjustment of therapy.
Facilitates automatic or user-alerted cessation or adjustment of treatment when a user-defined endpoint is reached, reducing undesirable side effects and improving treatment safety.
Allows integration with imaging to visualize lesion progression and provides feedback on lesion size and growth.
Documented Applications
Monitoring and control of tumor ablation during radiofrequency, microwave, laser, cryo-ablation, ultrasound, electroporation (reversible and irreversible), supraporation, and radiation therapy.
Active real-time monitoring of drug delivery, gene therapy, and nucleic acid or molecule delivery to tissue during membrane disruption techniques.
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