110 results about "Irreversible electroporation" patented technology

Methods for treating tissue with irreversible electroporation and immunotherapy are described. The methods include placing a probe in tissue within a human body, wherein the probe has at least a first electrode, applying a plurality of electrical pulses through the first electrode and a second electrode, causing irreversible electroporation (IRE) of the tissue within a target ablation zone, and administering one or more exogenous agents into the tissue within the target ablation zone or to the human, thereby stimulating or otherwise modulating an immune system response within the body.

The present invention provides systems, methods, and devices for electroporation-based therapies (EBTs). Embodiments provide patient-specific treatment protocols derived by the numerical modeling of 3D reconstructions of target tissue from images taken of the tissue, and optionally accounting for one or more of physical constraints or dynamic tissue properties. The present invention further relates to systems, methods, and devices for delivering bipolar electric pulses for irreversible electroporation exhibiting reduced or no damage to tissue typically associated with an EBT-induced excessive charge delivered to the tissue.

Treatment of damaged, diseased, abnormal, obstructive, cancerous or undesired tissue (e.g. a tumor, a benign tumor, a malignant tumor, a cyst, or an area of diseased tissue, etc) is provided by delivering specialized pulsed electric field energy to target tissue areas in a specific dose so as to obtain a superior outcome. The specialized PEF energy and delivery has been optimized to provide advanced treatment of target tissue areas, including destruction of undesired tissue and generation of improved inflammatory and immune responses. The specialized PEF energy provides superior outcomes to radiofrequency ablation and irreversible electroporation.

High-frequency irreversible electroporation (H-FIRE) is a tissue ablation modality employing bursts of electrical pulses in a positive phase-interphase delay-negative phase-interpulse delay pattern. Despite accumulating evidence suggesting the significance of these delays, their effects on therapeutic outcomes from clinically-relevant H-FIRE waveforms have not been studied extensively. The present invention provides methods of pulse delivery, including delays, that mitigate bubble formation and / or minimize the risk of arcing, such as due to the presence of bubbles, and / or minimize muscle stimulation are described herein.

The invention discloses a tumor irreversible electroporation ablation simulation prediction system, which comprises the following modules: a simulation model geometric structure establishment module, which is used for determining related parameters of a tumor irreversible electroporation ablation operation and a catheter electrode structure, and establishing a geometric structure of a simulation model; the geometric model and numerical model setting module is used for setting a geometric model and a numerical model; respectively constructing a two-electrode plate type three-dimensional finite element multi-physical field simulation model and a three-electrode plate type three-dimensional finite element multi-physical field simulation model for irreversible electroporation ablation of tumors; the data set establishment module is used for respectively performing simulation calculation on the two numerical models constructed by the geometric model and the numerical model setting module; the model training module is used for training the respective data sets of the two numerical models obtained by the data set establishing module by using a random forest regression algorithm; and the simulation prediction module is used for predicting the tumor ablation condition and the damage condition of surrounding normal tissues. The system provided by the invention can accurately predict the tumor ablation condition and the damage condition of surrounding normal tissues.

Systems and methods are provided for modeling and for providing a graphical representation of tissue heating and electric field distributions for medical treatment devices that apply electrical treatment energy through one or a plurality of electrodes. In embodiments, methods comprise: providing one or more parameters of a treatment protocol for delivering one or more electrical pulses to tissue through a plurality of electrodes; modeling electric and heat distribution in the tissue based on the parameters; and displaying a graphical representation of the modeled electric and heat distribution. In another embodiment, a treatment planning module is adapted to generate an estimated target ablation zone based on a combination of one or more parameters for an irreversible electroporation protocol and one or more tissue-specific conductivity parameters.

The invention discloses an irreversible electroporation damage assessment system and method based on myocardial dielectric properties, solves the problem of how to assess damage in a pulsed electric field ablation process, and belongs to the technical field of medical equipment. The system comprises an acquisition module and a workstation, wherein the acquisition module acquires an intracardiac ECG signal, a global electric field voltage signal of a target cardiac cavity, and impedance and temperature between ablation electrode pairs in real time; the work station processes the collected signals to obtain electrocardio characteristics, ablation parameters, temperature between the ablation electrode pairs, impedance drop, contact force and contact state between the ablation electrode pairs and myocardial tissue and ablation electrode position stability, the obtained signals are input into the evaluation model, and the evaluation model outputs IRE injury evaluation classification results. The evaluation model is realized based on a neural network. And real-time measurement and evaluation are carried out on PF ablation injury so as to assist a user to complete comprehensive, objective and accurate evaluation of the ablation effect.

Systems and methods are provided for modeling and for providing a graphical representation of tissue heating and electric field distributions for medical treatment devices that apply electrical treatment energy through one or a plurality of electrodes. In embodiments, methods comprise: providing one or more parameters of a treatment protocol for delivering one or more electrical pulses to tissue through a plurality of electrodes; modeling electric and heat distribution in the tissue based on the parameters; and displaying a graphical representation of the modeled electric and heat distribution. In another embodiment, a treatment planning module is adapted to generate an estimated target ablation zone based on a combination of one or more parameters for an irreversible electroporation protocol and one or more tissue-specific conductivity parameters.

The invention discloses a cartilage regeneration and repair method and system based on an irreversible electroporation technology. The method comprises the following steps: establishing an electroporation model of a cell membrane, simulating the distribution of an electric field and the potential change of the cell membrane, and predicting a membrane perforation effect; analyzing potential change according to an electroporation model, and combining energy consumption change of the cell membrane to obtain a critical condition of cell membrane pore formation; in combination with critical conditions, establishing an adaptive adjustment feedback mechanism, controlling the adjustment of electroporation parameters, and performing cartilage related gene transfection and cartilage repair; setting a comprehensive evaluation function, evaluating the repairing effect of the cartilage tissue, and adjusting electroporation parameters and a gene transfection strategy. The system comprises an electroporation model modeling module, a critical analysis module, an adaptive mechanism establishment module, a transfection repair module and an evaluation adjustment module. According to the method, the transfection efficiency of cartilage repair related genes can be improved and cartilage regeneration can be promoted by accurately regulating and controlling electroporation parameters and combining a self-adaptive feedback mechanism.

A method includes inserting an ablation catheter into an ablation site in a patient heart. Multiple electrocardiogram (ECG) signals are acquired. A refractory period of the patient heart is detected based on the acquired ECG signals. The ablation site is ablated using the ablation catheter during the detected refractory period.

Catheter systems and methods for the selective and rapid application of DC voltage to drive irreversible electroporation are disclosed herein. In some embodiments, an apparatus includes a voltage pulse generator and an electrode controller. The voltage pulse generator is configured to produce a pulsed voltage waveform. The electrode controller is configured to be operably coupled to the voltage pulse generator and a medical device including a series of electrodes. The electrode controller includes a selection module and a pulse delivery module. The selection module is configured to select a subset of electrodes from the series of electrodes. The selection module is configured identify at least one electrode as an anode and at least one electrode as a cathode. The pulse delivery module is configured to deliver an output signal associated with the pulsed voltage waveform to the subset of electrodes.

The invention belongs to the technical field of biomedicine and nano material electronics, and particularly relates to a low-voltage efficient sterilization electrode device based on local enhanced electric field treatment. According to the electrode device, vertically-oriented nanoneedles serve as a core functional layer, a nanoneedle array is arranged on a conductive substrate, the intensity of an electric field in a pinpoint area is amplified by multiple times through the lightning rod effect induced by the tips of the nanoneedles so as to achieve irreversible electroporation of a low-potential induced pathogen membrane, the length of the nanoneedles is 5-100 micrometers, and the length of the nanoneedles is 5-100 micrometers. The curvature radius of the needle tip is lt; and the sterilization device can realize nearly complete sterilization on escherichia coli and methicillin-resistant staphylococcus aureus within 5 minutes. The invention further provides a nanometer microneedle sterilization patch based on the local enhanced electric field, a self-power-supply or external-source-power-supply energy supply mode is adopted, and rapid sterilization of a wound can be achieved without medicine adding.

High-frequency irreversible electroporation (H-FIRE) is a tissue ablation modality employing bursts of electrical pulses in a positive phase-interphase delay-negative phase-interpulse delay pattern. Despite accumulating evidence suggesting the significance of these delays, their effects on therapeutic outcomes from clinically-relevant H-FIRE waveforms have not been studied extensively. The present invention provides methods of pulse delivery, including delays, that mitigate bubble formation and / or minimize the risk of arcing, such as due to the presence of bubbles, and / or minimize muscle stimulation are described herein.

Catheter systems and methods for the selective and rapid application of DC voltage to drive irreversible electroporation are disclosed herein. In some embodiments, an apparatus includes a voltage pulse generator and an electrode controller. The voltage pulse generator is configured to produce a pulsed voltage waveform. The electrode controller is configured to be operably coupled to the voltage pulse generator and a medical device including a series of electrodes. The electrode controller includes a selection module and a pulse delivery module. The selection module is configured to select a subset of electrodes from the series of electrodes. The selection module is configured identify at least one electrode as an anode and at least one electrode as a cathode. The pulse delivery module is configured to deliver an output signal associated with the pulsed voltage waveform to the subset of electrodes.

An electroporation ablation system for treating targeted tissue in a patient. The electroporation ablation system including an ablation catheter and an electroporation generator. The ablation catheter including a handle, a shaft having a distal end, and catheter electrodes situated at the distal end of the shaft and spatially arranged to generate electric fields in the targeted tissue in response to electrical pulses. The electroporation generator operatively coupled to the catheter electrodes and configured to deliver the electrical pulses in an irreversible electroporation pulse sequence that includes a preconditioning pulse sequence and an electroporation pulse sequence to one or more catheter electrodes. Wherein the preconditioning pulse sequence includes preconditioning electrical pulses configured to cause electrolysis near the targeted tissue and tetanizing skeletal muscle stimulation in the patient.

The application relates to the technical field of medical devices, in particular to a lung tumor treatment device based on irreversible electroporation and cryoablation, which comprises a single needle for generating high-voltage electric pulses, an ice knife for conveying cold gas medium and a CT display module for displaying CT images in real time, comprises a puncture sleeve, the puncture sleeve is provided with a sliding groove, the single needle and the ice knife are in gap cooperation with the sliding groove; a needle head is detachably connected in the sliding groove, the puncture sleeve is communicated with a conveying pipe, and the puncture sleeve is provided with an outlet for discharging the cold gas medium at one end; the sliding groove is also communicated with a collection mechanism for collecting external tissues, and the collection mechanism is used for collecting the external tissues based on the pushing of the needle head, the single needle and the ice knife; the application is convenient for switching surgical tools, reduces the damage to the surrounding tissues in the body during the treatment of lung ground glass nodules, and guarantees the removal effect of the lung ground glass nodules.

A method includes inserting an array of multiple electrodes, fitted at a distal end of a catheter, into a cavity in an organ of a patient. The array is brought into contact with an inner surface of the cavity. An input is received from a user, the input specifying one or more tissue segments to be ablated on the inner surface. In response to the input, using a processor, one or more pairs of the electrodes in the array are selected that, when driven with irreversible electroporation (IRE) signals, would ablate the specified tissue segments. The specified tissue segments are ablated by applying the IRE signals to the pairs of the electrodes.

A catheter for ablating cardiac tissue through irreversible electroporation, the catheter comprising a flexible circuit having a plurality of flex circuit branches and including an outwardly-facing ablation electrode including a plurality of ablation electrode branches extending proximally along a portion of a respective one of the flex circuit branches, and a support member having a plurality of support member branches, wherein the support member includes an electrically conductive base member covered by an electrically insulative coating, wherein each of the flex circuit branches is secured to a respective one of the support member branches, and the ablation electrode is electrically coupled to the electrically conductive base member.

The present invention describes a device, systems and a method which effect irreversible electroporation by means of energy-monitored control. An exemplary embodiment of the device has an electrical signal generator, an electrode pair, and an evaluation and control unit connected to the signal generator.

A catheter for ablating tissue by irreversible electroporation is disclosed. The catheter includes an elongate body having a proximal end and a distal end. The catheter also includes a first electrode spaced proximally from a second electrode along the elongate body, the first electrode and the second electrode each having a transition region terminating at opposing edges. The catheter further includes an insulator disposed on the electrode and extending between the first and second electrodes at the transition region. In the transition region, the electrode thickness of each electrode decreases toward the opposing edges, and the insulator thickness correspondingly increases to maintain a substantially constant total thickness.

An irreversible electroporation (IRE) is provided that includes setting an initial IRE protocol for applying IRE pulses by electrodes of a catheter placed in contact with tissue in an organ. Upon determining that the initial IRE protocol is expected to cause bubbles in blood, a notification is issued to a user. In response to the notification, user input is received from the user that selects between the initial IRE protocol and an alternative protocol that is expected not to cause bubbles. Depending on the user input, the IRE pulses are applied in accordance with the initial IRE protocol or the alternative IRE protocol.

The present invention relates to an Electronic apparatus (100) for delivering Coherent Sine Burst Irreversible Electroporation energy to a biological tissue (1) to be treated. The electronic apparatus comprises at least one electrode (3) that is positionable either on or near the biological tissue (1) to be treated. The electronic apparatus (100) also includes a power generator (2) for supplying electric energy to the or each electrode (3), and more particularly being configured to generate a respective electric signal (S) to energize the or each individual electrode (3). The or each electric signal (S) is formed by alternating over time a first electric signal (S1) with a second electric signal (S2), with each first electric signal (S1) being the same. The first electric signal (S1) is supplied to an individual electrode (3) during a first time interval (T1) and the second electric signal (S2) is supplied to the individual electrode (3) during a second time interval (T2), subsequent to the first time interval (T1). The first electric signal (S1) is a continuous bipolar signal which comprises two or more basic sine waves (SB) in the first time interval (T1). Each basic sine wave has a peak-to-peak mean amplitude in the range 2,000 V to 20,000 V and consists of one positive half-wave and one negative half-wave, with each half-wave having the same width. The first electric signal (S1) also has a frequency in the range 25 kHz to 75 kHz. Meanwhile, the second electric signal (S2) has an amplitude equal to zero in said second time interval (T2).

Several new inventions are detailed with this system, method, and device. While at the core, these inventions may ablate tissue by application of a short duration electric field, the therapy waveform used to apply the electric field is novel and optimized to preserve the intra-cellular content possible across different identified tissues. The optimized pulse biases tissue to an electroporation state and then presents a “hammer pulse” which may be along the same polarity or different polarity. This treatment minimizes thermal effects and is being defined as Pulse Field Immunotherapy (PFI). The antigens are left in situ and taken up by antigen-presenting cells in the periphery allowing the immune system to engage. Additional tissue feedback is obtained through an invention that performs measurements on tissue to determine its composition while the applicator is inserted into normal tissue, followed by diseased tissue. Tissue composition is compared against a library of characterized Tissue Identity Profiles (TIPs), allowing for immediate assessments and therapy to be provided while the patient is undergoing traditional diagnosis.

Catheter systems and methods for the selective and rapid application of DC voltage to drive irreversible electroporation are disclosed herein. In some embodiments, an apparatus includes a voltage pulse generator and an electrode controller. The voltage pulse generator is configured to produce a pulsed voltage waveform. The electrode controller is configured to be operably coupled to the voltage pulse generator and a medical device including a series of electrodes. The electrode controller includes a selection module and a pulse delivery module. The selection module is configured to select a subset of electrodes from the series of electrodes. The selection module is configured identify at least one electrode as an anode and at least one electrode as a cathode. The pulse delivery module is configured to deliver an output signal associated with the pulsed voltage waveform to the subset of electrodes.

The present invention discloses a micellar mixed system for enhancing the therapeutic effect of irreversible electroporation on pancreatic cancer and a preparation method thereof. By mixing CGP37157-loaded PEG-PCL micelles (CGP37157@PEG-PCL) with a CaCl2 solution to form an injectable micellar mixed system, the poorly water-soluble CGP37157 sodium-calcium exchange inhibitor can be delivered into tumor cells. During electroporation therapy, as the permeability of tumor cells increases, the excretion of calcium ions in mitochondria is inhibited, further leading to mitochondrial calcium overload and accelerating tumor cell death. This can effectively improve the efficiency of IRE treatment and has good clinical application prospects.

This application provides a pulse generation system, an irreversible electroporation device, and a related method. The pulse generation system generates a high-voltage pulse signal by controlling the conduction of a pulse transmission circuit according to a control signal. This high-voltage pulse signal is applied to biological tissue through at least one pair of electrodes, causing irreversible electroporation and cell death within the tissue. Furthermore, the pulse generation system can also generate a low-voltage pulse signal to collect electrical information from the biological tissue. This electrical information is then used to determine the effectiveness of the irreversible electroporation and whether to continue the high-voltage pulse treatment. Thus, a single pulse generation system can generate both high-voltage and low-voltage pulses without requiring additional equipment, making it more convenient to use. Moreover, since it is a single circuit, the control effect is better.

The application discloses a tumor irreversible electroporation ablation operation parameter optimization system, comprising an initialization population module, an individual grade division module, a first generation sub-population generation module, a new population determination module, a new parent population establishment module, a new parent population update module, a merging module and a result selection module. The NSGA-II algorithm in the genetic algorithm is adopted to optimize the operation parameters, and a threshold setting is added. The system can assist doctors in formulating the best operation parameter scheme, so as to achieve the operation target of maximizing killing of tumor tissues, minimizing damage to normal tissues and minimizing the number of pulses.

To provide a device and method for irreversible electroporation of tissue.SOLUTION: A device and a method for the electroporation are described. An exemplary embodiment of the device has a catheter and a signal generator-evaluation unit connected to the proximal end of the catheter.SELECTED DRAWING: Figure 1

The invention discloses a steep pulse generator for high-frequency irreversible electroporation, which is characterized in that a pulse generation module simultaneously conducts positive and negative Sic MOSFETs (Metal Oxide Semiconductor Field Effect Transistor) through a bipolar push-pull structure to ensure that the rising / falling time, amplitude and pulse width of positive and negative pulses are strictly symmetrical and reduce tissue damage or non-uniform energy distribution caused by waveform asymmetry. Meanwhile, an adopted voltage closed-loop feedback control network can automatically compensate energy loss caused by tissue impedance fluctuation, it is ensured that the electric field intensity is stable, the penetration depth of the electric field can be accurately controlled, and the system is suitable for scenes with high treatment precision requirements. And multi-path output is expanded through the decoder, and flexible configuration of different electrode arrays is supported. Different modules are arranged independently in a split-board mode, high-voltage and low-voltage circuits are designed in a full-isolation mode, whole machine repair is not needed when faults occur, the equipment maintenance cost is reduced, and the expansibility of the modules is high.