45 results about "Irreversible electroporation" patented technology

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.

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.

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 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 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.

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.

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.

An energy delivery therapy system facilitates determining various characteristics of a lesion and / or tissue at a treatment site, such as the size and / or location of the lesion; stiffness and / or elasticity of the tissue; an impedance or resistance of the tissue (which may affect the form of energy, such as electroporation and / or irreversible electroporation applied to the tissue); and / or the effect of the treatment applied to the lesion. The collected information about the treatment site may be used to assist in predicting and measuring lesions, and / or to determine an appropriate treatment plan based on the condition of each patient. After the energy delivery assembly has been withdrawn from the treatment site, indicia may be used to facilitate localization of the treatment site.

A system for ablating cardiac tissue through irreversible electroporation is disclosed. The system includes an electroporation and mapping catheter, a graphical display, and a controller coupled to the graphical display and the catheter. The catheter includes an electrode assembly defining a distally located central hub portion and splines, each spline including a distal end portion extending from the central hub portion, and a proximal end portion attached to and constrained by an outer shaft. The electrode assembly includes electrodes having sensing electrodes located on each spline. The controller determines an impedance from a four-terminal configuration wherein a current is injected to a current carrying pair of electrodes and a volage is measured across a sensing pair of electrodes comprising sensing electrodes. The controller generates a graphical representation of a model of the impedance of the spline on the graphical display.

The cryo-assisted Irreversible Electroporation (IRE) ablation system includes an IRE ablation generator, a coolant supply, cryo-assisted IRE ablation stylet(s), and a cryo-assisted IRE ablation controller for controlling the IRE ablation generator and the cryo-assisted IRE ablation stylet(s). The ablation stylets include a stylet needle having longitudinally directed strip electrode(s) and a freezing module for cooling a longitudinal directed ice-forming surface for freezing a generally hemi-ellipsoidal volume of target tissue. The controller repeatedly switches the ablation stylets between an IRE ablation energy mode and a non-cryoablation freezing mode whereupon, in an absence of ice formation, each cryo-assisted IRE ablation stylet generates a pre-ice 3D electric field pattern in target tissue and, subsequent to a generally hemi-ellipsoidal ice formation, the ice formation modifies the pre-ice 3D electric field pattern to a post-ice 3D electric field pattern different from the pre-ice 3D electric field pattern.

Disclosed herein is an electroporation system including a catheter shaft, at least one electrode coupled to the catheter shaft at a distal end thereof, and a signal generator. The signal generator is coupled in communication with the at least one electrode. The signal generator supplies a biphasic pulse to the at least one electrode, the biphasic pulse including a first phase having a first polarity, a first initial voltage amplitude, and a first pulse width. The biphasic pulse includes a second phase having a second polarity opposite to the first polarity, a second initial voltage amplitude, and a second pulse width, wherein at least one of the first initial voltage amplitude or the first pulse width is different from the second initial voltage amplitude or the second pulse width, respectively. A leading edge of the second phase occurs after an interphase delay following a trailing edge of the first phase.

An energy supply treatment system that enables determination of various characteristics of the lesion and / or tissue at the treatment site, such as the size and / or location of the lesion, the stiffness and / or elasticity of the tissue, the impedance or resistance of the tissue (which can affect the form of energy applied to the tissue, such as electroporation and / or irreversible electroporation), and / or the effect of the treatment applied to the lesion. Information collected regarding the treatment site can be used to help predict and measure the lesion and / or determine an appropriate treatment plan for each patient. Markers can be used to enable localization of the treatment site after the energy supply assembly has been withdrawn from the treatment site.

A system for performing irreversible electroporation within a tissue under a skin surface of a patient, the system including: a power source configured to generate power; a base; and at least one electrode extending from the base, where the at least one electrode is configured to receive the power and based on the power to generate an electric field sufficient to porate a cell membrane within the tissue while increasing a temperature of the skin surface less than 3 deg C. during poration.

The present disclosed subject matter provides a return electrode, such as a body surface electrode, which includes an accelerometer, for detecting movement of the body at and proximate to the location of the return electrode. The body movement results from pulses from an Irreversible Electroporation (IRE) pulse generator which are delivered to the return electrode, by a pulse delivery electrode. The data associated with the body movement at each location on the body of the return electrode, is used to determine suitable, and in some cases optimal, locations for return electrodes for IRE procedures.

The invention discloses a dual-electrode irreversible electroporation ablation needle, an ablation method and application. The method comprises the steps that the number of ablation needles and an electrode combination ablation mode are selected according to the form and the size of a focus; an irreversible electroporation pulse electric signal is applied in a selected electrode combination ablation mode, so that an irreversible electroporation ablation area is formed in the tissue around the needle body, and the focus tissue is ablated; the ablation mode comprises an ablation mode between the first electrode and the second electrode in the single ablation needle; and ablation modes between the first electrodes, between the second electrodes or between the cross electrodes between the different ablation needles. Multiple ablation modes are achieved through the two needles, the ablation mode is flexible, the electric field coverage range is adjustable, incomplete ablation is effectively avoided, the ablation efficiency is improved, the number of the distributed needles is reduced, the consistency, controllability and reliability of ablation are improved while the surgical operation process is simplified, and good clinical application prospects are achieved.

The invention relates to the technical field of cardiac ablation, in particular to an irreversible electroporation ablation system with OCT (optical coherence tomography), which comprises an electrophysiology catheter, the electrophysiology catheter comprises a catheter head end, the catheter head end is provided with an electrode, a magnetic positioning sensor, a pressure sensor and an OCT sensor, and the OCT sensor is used for emitting a light beam to irradiate an ablation position and collecting scattered light from tissues; the ablation equipment is electrically connected with the electrophysiology catheter; the three-dimensional mapping system is electrically connected with the electrophysiology catheter and the ablation device, the three-dimensional mapping system comprises a magnetic positioning module, a pressure monitoring module and an OCT processing module, the OCT processing module is used for optical coherence tomography, and the three-dimensional mapping system is used for displaying electrophysiology catheter position information, catheter head end pressure and OCT imaging information. According to the invention, a one-dimensional depth image, a two-dimensional section image and a three-dimensional image can be generated in real time, an ablation position is scanned through an OCT technology, real-time image display can be obtained, and a doctor performing a pulse ablation operation is helped to timely and accurately judge an ablation result.

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.

This invention relates to the field of image assessment technology and discloses a method and system for image assessment after nanosecond pulse ablation. The method involves: acquiring images of the ablation area after nanosecond pulse ablation and dividing it into a deterministic irreversible region, an indeterminate border region, a reversible edema region, and a normal region; constructing an original pairwise set within the deterministic irreversible region and a weak pairwise set between the deterministic irreversible region and the indeterminate border region; calculating the attribute label of each voxel in the indeterminate border region and combining it with the deterministic irreversible region to output an irreversible electroporation region. This invention can accurately identify voxels in the indeterminate border region that truly constitute irreversible damage, and combine them with the deterministic irreversible region to output a complete irreversible electroporation region, providing a reliable quantitative assessment indicator of ablation integrity for clinical practice.

An exemplary pulsed electric field system and method that can uniformly emit electrical pulses via use of a conductivity-controlled liquid medium to penetrate a pre-defined depth of a target tissue for a whole or region of a hollow or tubular organ to induce a tissue response. The conductivity-controlled liquid medium allows more uniform electrical pulses to be generated with less localized or focal bursts of pulses, which can reduce the required power rating of the electric generator for the pulses. The pulsed electric field system and method can be used for irreversible electroporation and subsequent exfoliation of the surface tissue, electroporation, pulsed field ablation, or cell stimulation.

A catheter for ablating cardiac tissue through irreversible electroporation is disclosed. The catheter includes an elongated shaft having a distal region, the elongated shaft defining a longitudinal axis. A set of splines extend from the distal region of the shaft for translation along the longitudinal axis to transition between a collapsed configuration and an expanded configuration. Each spline forms a loop in the expanded configuration. Each spline of the set of splines includes an electrode assembly having a flexible circuit. The flexible circuit includes lead traces electrically coupled to electrodes on a surface of each of the respective splines.

The present application relates to a method for detecting the degree of irreversible electroporation by scanning electrochemical microscopy (SECM), which realizes rapid and efficient detection of the degree of cell electroporation by measuring the membrane permeability (Pm) of cells after stimulation by a pulsed electric field. The method first measures the approach curve of the SECM probe to the cells, then converts the approach curve into the membrane permeability of the cells to complete the measurement of the degree of electroporation, and measures the survival rate curve of the cells by the existing detection method, establishes the relationship between the Pm value and the cell survival rate, verifies the detection of irreversible electroporation by the membrane permeability of the cells, and finds that the law of the change of the membrane permeability with the pulsed voltage is almost the same as the law of the change of the cell survival rate with the pulsed voltage, so the method for measuring the degree of cell electroporation by SECM is effective and reliable.

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.

To provide an electroporation ablation system for treating targeted tissue in a patient.SOLUTION: The electroporation ablation system includes an ablation catheter and an electroporation generator. The ablation catheter includes 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 is operatively coupled to the catheter electrodes and configured to deliver the electrical pulses in an irreversible electroporation pulse sequence, which includes a preconditioning pulse sequence and an electroporation pulse sequence, to one or more catheter electrodes. The preconditioning pulse sequence includes multiple preconditioning electrical pulses configured to cause electrolysis near the targeted tissue and tetanizing skeletal muscle stimulation in the patient.SELECTED DRAWING: Figure 1

The invention relates to a CT compatible universal probe support for tumor percutaneous ablation, comprising: a main body bearing plate comprising a bottom plate adapted to a CT examination bed and an integrally formed convex platform perpendicular to the side edge of the bottom plate; the clamping base is integrally formed by an upper clamping arm, a lower clamping arm and a connecting plate which are parallel to each other, a C-shaped clamping opening is formed, and the clamping base is buckled on the protruding platform; the telescopic supporting rod assembly is vertically connected to the connecting plate of the clamping base and comprises a hollow cylindrical rod piece which is connected in a sleeved mode; the multi-interface bottom plate is fixedly connected to the top end of the telescopic supporting rod assembly and is in a long strip shape, and a plurality of bayonet type quick-release interfaces are distributed on the multi-interface bottom plate in an integrated matrix mode; the universal probe bracket comprises a low-artifact universal locking tube, a connecting cap and a fixing clamp for clamping an ablation probe which are connected in sequence; and the low-artifact universal locking pipe is arranged on the bayonet type quick release interface. The method is suitable for keeping the probe absolutely stable cryoablation, microwave ablation, radiofrequency ablation, irreversible electroporation ablation and other operations in the CT scanning period.

An electroporation ablation system for treating a target tissue in a patient. The electroporation ablation system includes an ablation catheter and an electroporation generator. The ablation catheter includes a handle, a shaft having a distal end, and a catheter electrode at the distal end of the shaft and spatially arranged to generate an electric field in the target tissue in response to an electric pulse. The electroporation generator is operably coupled to the catheter electrode and configured to deliver an electric pulse in a sequence of irreversible electroporation pulses to the one or more catheter electrodes, the sequence of irreversible electroporation pulses including a pre-treatment pulse sequence and an electroporation pulse sequence. Wherein the pre-treatment pulse sequence includes pre-treatment electric pulses configured to cause electrolysis in the vicinity of the target tissue and to cause skeletal muscle stimulation tetanus in the patient.

The invention discloses an irreversible electroporation tissue ablation effect evaluation method and device, and relates to the technical field of pulse ablation. After impedance spectrums before and after ablation are obtained, relaxation time distribution DRT inversion is carried out on the impedance spectrums before and after ablation, so that impedance spectrum information on a frequency domain is converted into a relaxation time distribution function on a time domain, and the relaxation time distribution function is used for evaluating the ablation effect of the irreversible electroporation tissue. A reasonable circuit topology does not need to be preset for analysis, and relaxation time distribution characteristics are directly extracted from impedance spectrum data; then, a plurality of corresponding characteristic peaks in the relaxation time distribution function are selected, the change ratio of the peak area of the characteristic peaks after ablation is obtained, and in the process, a plurality of detection interpretation processes are mapped to quantification of the change ratio of the peak area of the characteristic peaks after ablation, so that the specific ablation mechanism is clearly distinguished; and finally, performing linear fitting on the change ratio of the peak areas of the plurality of characteristic peaks and the real tissue ablation depth to form a relation model, thereby realizing accurate irreversible electroporation tissue ablation effect evaluation.