Methods, systems, and apparatus for tracking ablation equipment and generating damage lines.

Abstract

Systems, devices, and methods for electroporation ablation therapy are disclosed. [Solution] The device may be configured to activate a field generator to generate an electric or magnetic field, so that a signal is received by a receiver connected to an ablation device positioned adjacent to the tissue surface. Processing data related to the signal may be acquired. The position and orientation of the ablation device may be determined based on the processing data. The planned ablation areas of the ablation device on the tissue surface may be determined based on the position and orientation of the ablation device. A map of the tissue surface and a visual representation of the planned ablation areas positioned on the map of the tissue surface may be displayed.

Description

[Technical Field]

[0001] The embodiments described herein generally relate to systems, apparatus, and methods for tracking medical devices for therapeutic electrical energy transmission, more specifically ablation devices (e.g., ablation catheters), and for generating injury lines using such devices. [Background technology]

[0002] Pulsed-field ablation, which uses the application of high-voltage pulses, has been shown to be suitable for the rapid and effective generation of damage in cardiac tissue as well as other target biostructures. In the cardiac environment, pulsed-field ablation is used for local ablation or the generation of individual localized damage. For example, an ablation catheter configured for local ablation may be used for pulsed-field ablation delivered to cardiac tissue by irreversible electroporation.

[0003] In clinical catheterization laboratories, electroanatomical mapping systems using impedance tracking systems or impedance-based location systems may be used to provide three-dimensional visualization feedback of devices placed within a patient's biostructure. Furthermore, electromagnetic tracking sensors may be integrated into the devices and used to track these devices within the patient's biostructure.

[0004] It may be desirable to track the characteristics of the ablation device during ablation surgery and to use such information to evaluate the characteristics of the ablation, for example, to assist in planning the ablation surgery. [Overview of the project]

[0005] Systems, devices, and methods for visualizing and generating local tissue ablation using ablation catheters are described herein. In some embodiments, the ablation devices used in these systems may be placed in the epicardium or within the heart in cardiac applications.

[0006] In some embodiments, the apparatus may include a memory and a processor operably coupled to the memory, the processor being configured to activate a field generator to generate an electric or magnetic field so that a signal is received by a receiver coupled to an ablation device positioned adjacent to the tissue surface, to acquire processing data related to the signal, to determine the position and orientation of the ablation device based on the processing data, to determine the planned ablation areas of the ablation device on the tissue surface based on the position and orientation of the ablation device, and to display a map of the tissue surface and a visual representation of the planned ablation areas on the map of the tissue surface by an output device.

[0007] In some embodiments, the method may include receiving data in a processor indicating a signal received by a receiver connected to an ablation device positioned adjacent to the tissue surface, the receiver receiving a signal in response to an electric or magnetic field generated by a field generator; determining the position and orientation of the ablation device in the processor based on the data indicating the signal; determining the planned ablation area of ​​the ablation device on the tissue surface in the processor based on the position and orientation of the ablation device; and displaying a map of the tissue surface and a visual representation of the planned ablation area in the map of the tissue surface by an output device operably connected to the processor.

[0008] In some embodiments, the system may include a field generator configured to generate an electric or magnetic field, a signal generator configured to generate pulse waveforms for ablation of tissue, an output device, and a processor operably coupled to the field generator, the signal generator, and the output device, the processor being configured to activate the field generator to generate an electric or magnetic field so that a signal is received by a receiver coupled to an ablation device positioned adjacent to the tissue surface, to acquire processing data associated with the signal, to determine the position and orientation of the ablation device based on the processing data, to determine the planned ablation areas of the ablation device on the tissue surface based on the position and orientation of the ablation device, to cause the output device to display a map of the tissue surface and a visual representation of the planned ablation areas on the map of the tissue surface, and to activate the signal generator to generate pulse waveforms to be transmitted to the ablation device so that the ablation device produces ablated areas corresponding to the planned ablation areas, depending on the planned ablation areas corresponding to the desired ablation areas.

[0009] In some embodiments, the apparatus may include memory and a processor may be operably coupled to the memory, the processor activating a field generator to generate an electric or magnetic field so that a signal can be received by a receiver coupled to an ablation device positioned adjacent to the tissue surface, acquiring processing data related to the signal, determining the position and orientation of the ablation device based on the processing data, displaying a map of the tissue surface constructed from a plurality of points forming a point cloud using an output device, determining the shortest distance from the ablation device to the tissue surface, identifying a set of points from the plurality of points that are within a predetermined distance from the distal end of the ablation device according to the shortest distance being smaller than a predetermined value, determining the center of the set of points, determining a local tangent plane to the surface extending through that center, determining a center representing the center of the planned ablation area, which is the location of the center of the surface of the ablation area, based on the position and orientation of the ablation device with respect to the local tangent plane, and displaying a visual representation of the planned ablation area in the map of the tissue surface using an output device.

[0010] In some embodiments, the planned ablation area may be a first planned ablation area, and the processor is further configured to determine a second planned ablation area of ​​the ablation device on the tissue surface in response to changes in the position or orientation of the ablation device, and to display a visual representation of the ablated area related to the first planned ablation area on the tissue surface map and a visual representation of the second planned ablation area on the tissue surface map by an output device.

[0011] In some embodiments, the processor may be configured to display a visual representation of the ablated areas and a visual representation of the second planned ablated areas by projecting the ablated areas onto a map of the tissue surface using a first set of marks, and projecting the second planned ablated areas onto the map of the tissue surface using a second set of marks different from the first set of marks.

[0012] In some embodiments, the ablation apparatus may include a set of splines, each spline from the set of splines including a set of proximal electrodes and a set of distal electrodes, so that the set of splines includes a plurality of proximal electrodes and a plurality of distal electrodes as a whole, and the processor is configured to determine the position and orientation of the ablation apparatus by determining a set of geometric parameters of the ablation apparatus based on processing data, determining the morphology of the ablation apparatus based on the set of geometric parameters, and determining at least one of the position and orientation of the ablation apparatus based on the determined morphology of the ablation apparatus and the processing data.

[0013] In some embodiments, the processor may be configured to determine the orientation of the ablation device by determining at least a longitudinal unit vector associated with the ablation device. In some embodiments, the processor may be configured to determine the orientation of the ablation device by at least (1) identifying an unfolded form having a set of associated geometric parameters that most closely matches a determined set of geometric parameters, and (2) identifying an unfolded form in a set of unfolded forms, each having a set of associated geometric parameters.

[0014] In some embodiments, the processor may be configured to identify an unfolded form having a set of relevant geometric parameters that most closely matches a determined set of geometric parameters by using the least squares method. In some embodiments, an amplifier may be configured to amplify the signal received by a receiver, and the processor is configured to obtain processed data by digitizing and processing the signal amplified by the amplifier. In some embodiments, the processor may be further configured to display a visual representation of the ablation device by an output device based on the position and orientation of the ablation device.

[0015] In some embodiments, the ablation device may include multiple electrodes, and the processor is further configured to identify from the multiple electrodes in contact with the tissue surface the electrode whose center is located where the electrode's location corresponds to the center of the planned ablation area, and to identify from the multiple planned ablation area shapes based on the position and orientation of the ablation device the planned ablation area has. In some embodiments, the processor may be further configured to construct a map of the tissue surface based on processing data associated with signals received by the receiver as the ablation device is advanced to multiple locations along the tissue surface. In some embodiments, the default value may be less than about 4 mm, and the default distance may be less than about 3 cm.

[0016] In some embodiments, the method may include: receiving data indicating a signal received by a receiver connected to an ablation device positioned adjacent to the tissue surface and receiving a signal in response to an electric or magnetic field generated by a field generator, in one of a set of processors; determining the position and orientation of the ablation device based on the data indicating the signal in one of the set of processors; displaying a map of the tissue surface constructed from a plurality of points forming a point cloud by an output device operably connected to one of the set of processors; determining the shortest distance from the ablation device to the tissue surface in one of the set of processors; identifying a set of local points from a plurality of points in accordance with the shortest distance smaller than a default value, within a predetermined distance from the distal end of the ablation device; determining a local tangent plane to the surface based on the set of local points in one of the set of processors; determining the center of a planned ablation area based on the position and orientation of the ablation device with respect to the local tangent plane, in one of the set of processors; and displaying a visual representation of the planned ablation area in the map of the tissue surface by an output device.

[0017] In some embodiments, the method may further include activating a signal generator to cause the ablation device to generate a pulse waveform to be transmitted to the ablation device in order to produce an ablated area corresponding to a planned ablation area. In some embodiments, the method may further be configured to display a visual representation of the ablated area in a map of the tissue surface, distinct from a visual representation of the planned ablation area, by an output device and based on the transmission of the pulse waveform.

[0018] In some embodiments, the reception of data representing a signal received by a receiver may occur when the ablation device is located at a first location, the location of the ablation device is the first location of the ablation device, the orientation of the ablation device is the first orientation of the ablation device, and the planned ablation area is the first planned ablation area. The method further includes receiving data representing a signal received by a receiver in response to an electric or magnetic field when the ablation device is located at a second location different from the first location, determining the second location and second orientation of the ablation device based on the data representing the signal when the ablation device is located at the second location, determining a second planned ablation area of ​​the ablation device on the tissue surface based on the second location and second orientation of the ablation device, and displaying a visual representation of the ablated area using a first set of markers and a visual representation of the second planned ablation area using a second set of markers different from the first set of markers, by an output device.

[0019] In some embodiments, the ablated area may be a first ablated area, and the method further includes activating a signal generator to produce a pulse waveform to be transmitted to the ablation device in response to a second planned ablated area having a slight overlap greater than a threshold with the first ablated area, so that the ablation device produces a second ablated area corresponding to the second planned ablated area, and the first and second ablated areas form part of continuous damage in the tissue surface. In some embodiments, the threshold may be a default value.

[0020] In some embodiments, the signal may be a first signal, and the method further includes: (i) identifying at each of the locations from which an ablation device including multiple electrodes is being operated, at each of the locations from which an ablation device including multiple electrodes is being operated, data representing a second signal received by a receiver in accordance with electric and magnetic fields generated by a field generator; (ii) identifying at least one electrode in contact with the tissue surface from the multiple electrodes based on at least one of the electrocardiogram (ECG) data recorded from the electrodes; generating a point cloud including multiple points, where each of the multiple points corresponds to the location of at least one electrode identified at a different location from the multiple locations; and constructing a map of the tissue surface using the point cloud.

[0021] In one embodiment, the ablation device may include a set of splines, each spline of which includes a set of proximal electrodes and a set of distal electrodes, so that the set of splines includes a plurality of proximal electrodes and a plurality of distal electrodes as a whole, and the determination of the position and orientation of the ablation device includes determining a set of geometric parameters of the ablation device based on received data representing a signal, determining the morphology of the ablation device based on the set of geometric parameters, and determining at least one of the determined morphology of the ablation device and the position or orientation of the ablation device based on received data representing a signal. In some embodiments, the method may further include displaying a visual representation of the ablation device on a map of the tissue surface based on the position and orientation of the ablation device using an output device.

[0022] In some embodiments, the system may include a field generator configured to generate an electric or magnetic field, a signal generator configured to generate a pulse waveform for ablation of tissue, an output device, and a processor operably connected to the field generator, signal generator and output device, the processor activating the field generator to generate an electric or magnetic field so that the signal is received by a receiver connected to an ablation device positioned adjacent to the tissue surface, acquiring processing data related to the signal, determining the position and orientation of the ablation device based on the processing data, displaying a map of the tissue surface constructed from a plurality of points forming a point cloud on the output device, and the shortest distance from the ablation device to the tissue surface The system is configured to determine a distance, identify a set of local points from multiple points that are within a predetermined distance from the distal end of the ablation device according to the shortest distance which is smaller than a predetermined value, determine a local tangent plane to the surface based on the set of local points, determine the center of the planned ablation area based on the position and orientation of the ablation device with respect to the local tangent plane, display a visual representation of the planned ablation area on a map of the tissue surface on the output device, and activate a signal generator to generate a pulse waveform to be transmitted to the ablation device so that the ablation device produces an ablated area corresponding to the planned ablation area according to the planned ablation area corresponding to the desired ablation area.

[0023] In some embodiments, the field generator may include a set of electrode patches that generate one or more electric fields, and the electric or magnetic field includes one or more electric fields generated by the set of electrode patches. In some embodiments, the field generator may include a set of transmitter coils, each of which generates a time-varying magnetic field, and the electric or magnetic field includes a time-varying magnetic field generated by the set of transmitter coils. In some embodiments, the processor may be further configured to cause the output device to change the visual display of a planned ablation area to indicate that the planned ablation area is to be ablated, in response to activating the signal generator.

[0024] In some embodiments, the ablation device may include a set of splines, each spline of the set of splines including a set of proximal electrodes and a set of distal electrodes, so that the set of splines collectively includes a plurality of proximal electrodes and a plurality of distal electrodes, and the processor is configured to determine a set of geometric parameters of the ablation device based on the processing data, determine the shape of the ablation device based on the set of geometric parameters, and determine at least one of the position or orientation of the ablation device based on the determined shape of the ablation device and the processing data, thereby determining the position and orientation of the ablation device.

[0025] In some embodiments, the ablation device includes a plurality of splines configured to form a basket shape. In some embodiments, the ablation device includes a distal portion including a linear shape. BRIEF DESCRIPTION OF THE DRAWINGS

[0026] [Figure 1A] FIG. 1 is a schematic diagram of a mapping / device location confirmation system according to an embodiment. [Figure 1B] FIG. 2 is a schematic diagram of an electroporation system according to an embodiment. [Figure 2A] FIG. 3 is a side view of an ablation catheter according to an embodiment. [Figure 2B] FIG. 4A is a front view of the ablation catheter shown in FIG. 2A. [Figure 3] FIG. 5 is a schematic cross-sectional view of a set of electrodes of an ablation catheter according to an embodiment. [Figure 4] FIG. 6 is a schematic diagram of a simulated view of an ablation device within a patient's biological structure according to an embodiment. [Figure 5] FIG. 7 is a schematic diagram of a simulated view of an ablation device within a patient's biological structure according to an embodiment. [Figure 6] FIG. 8 is a schematic diagram of a simulated view of an ablation device within a patient's biological structure according to an embodiment. [Figure 7] This is a diagram illustrating the ablation device within a patient's biological structure according to the embodiment. [Figure 8] This is a diagram illustrating the ablation device within a patient's biological structure according to the embodiment. [Figure 9A] This is a flowchart of tissue mapping and ablation surgery according to the embodiment. [Figure 9B] This is a flowchart of tissue mapping and ablation surgery according to the embodiment. [Figure 10] This is a perspective view of a biological structure surface map according to the embodiment. [Figure 11] This is a perspective view of a biological structure surface map according to the embodiment. [Figure 12] This is a perspective view of a biological structure surface map according to the embodiment. [Figure 13] This is a perspective view of a biological structure surface map according to the embodiment. [Figure 14] This is a diagram illustrating the ablation device in a patient's biological structure according to the embodiment. [Figure 15] This is a diagram illustrating the ablation device in a patient's biological structure according to the embodiment. [Figure 16] This is a diagram illustrating the ablation device in a patient's biological structure according to the embodiment. [Figure 17] This is a perspective view of a biological structure surface map according to the embodiment. [Figure 18] This is a perspective view of a biological structure surface map according to the embodiment. [Figure 19] This is a perspective view of a biological structure surface map according to the embodiment. [Figure 20] This is a perspective view of a biological structure surface map according to the embodiment. [Modes for carrying out the invention]

[0027] Systems, apparatus, and methods for the selective and rapid application of pulsed electric fields to ablate tissue by irreversible electroporation are described herein. Generally, the systems, apparatus, and methods described herein may be used to generate damage lines by ablation apparatus (e.g., local ablation apparatus).

[0028] In some embodiments, the systems, devices, and methods described herein provide spatial tracking of an ablation device (e.g., a catheter) within a body cavity to assist in tissue ablation, such as generating adjacent transmural injury lines with a local ablation catheter. Such spatial tracking provides, for example, immediate tracking of the spatial location and orientation of the ablation device. Systems, devices, and methods incorporating spatial tracking capabilities may enable immediate surgical planning and may be applied to pulsed field ablation surgery environments by transmitting high-voltage pulse waveforms to generate injury using irreversible electroporation.

[0029] Pulsed field ablation for cardiac tissue ablation has recently been demonstrated to be a suitable procedure for the rapid and effective generation of ablation injury. In the cardiac environment, the generation of local ablation and individual local injury are relevant applications of pulsed field ablation. In clinical catheterization laboratories, electroanatomical mapping systems (e.g., the CARTO system manufactured by Biosense Webster or the NavX system manufactured by Abbott Laboratories) may be used to provide three-dimensional visualization feedback for catheter devices positioned within cardiac biostructure or ventricles.

[0030] Electromagnetic tracking sensors can be integrated into catheter devices using electrodes configured to track the device's position (e.g., immediately) within a target three-dimensional volume. Suitable electromagnetic tracking or location systems for medical applications include, for example, systems and sensors manufactured by Northern Digital. Using a catheter with such sensors in the heart to advance to different locations within the ventricles, location data from the catheter electrodes and / or ECG signals recorded from the electrodes can be used to reconstruct the ventricular surface biostructure.

[0031] Furthermore, or alternatively, a device location tracking system may determine the location of a device (e.g., a catheter) using an electric field or voltage gradient generated by a set of surface electrode patches on a patient, for example, a potential difference occurring between the surface electrode patches. With at least three such independently paired potential differences, not all of which are coplane, the three-dimensional location of the electrodes can be estimated based on potentials measured by electrodes or sensors associated with one or more surface patches. That is, impedance measurements can be estimated based on measured currents and / or voltages. Suitable techniques and methods for estimating spatial location using such potential differences or voltage gradients of an electrode set are also called impedance tracking or impedance-based location systems and are incorporated into electroanatomical mapping systems such as the NavX system manufactured by Abbott Laboratories, the Rhythmia system manufactured by Boston Scientific, or the CARTO system manufactured by Biosense Webster. In some embodiments, when a catheter device includes an electromagnetic sensor for electromagnetic tracking and is used in conjunction with an impedance tracking system, the electrode location on the catheter can be estimated more accurately than by using impedance tracking without electromagnetic tracking.

[0032] If a local catheter is configured to transmit pulsed-field ablation damage (e.g., damage caused by irreversible electroporation) along with a high-voltage pulse waveform, the characteristics of the damage (e.g., spatial extent and shape) transmitted using such a catheter at a given pulsed-field ablation waveform and voltage can be determined using computer modeling and / or damage data from studies or past surgeries (e.g., preclinical or animal studies and / or surgeries). Depending on the electrode shape of the local catheter, the shape of the damage generated by such ablation generally depends, at least in part, on the orientation of the device to the local tissue surface or wall.

[0033] The systems and methods described herein relate to planned injury shapes or ablation areas on a biostructure map or surface rendering that can enable a series of injuries (e.g., adjacent and / or transmural) to be effectively generated within a predetermined biostructure region. In some embodiments, a local ablation catheter configured to generate pulsed field ablation injuries can take on a variety of geometric shapes. In some embodiments, the methods, systems and devices disclosed herein may include one or more methods, systems and devices described in U.S. Patent Application No. 16 / 375,561, filed April 4, 2019, “Systems, Devices and Methods for Local Ablation,” U.S. Patent Application No. 16 / 886,514, filed May 28, 2020, and International Patent Application No. PCT / US2020 / 037948, filed June 16, 2020, the contents of which are incorporated herein by reference in their entirety.

[0034] As used herein, the term "electroporation" refers to the application of an electric field to a cell membrane to alter its permeability to the extracellular environment. As used herein, the term "reversible electroporation" refers to the application of an electric field to a cell membrane to temporarily alter its permeability to the extracellular environment. For example, a cell undergoing reversible electroporation may exhibit temporary and / or intermittent structures of one or more pores that close when the electric field in its cell membrane is removed. As used herein, the term "irreversible electroporation" refers to the application of an electric field to a cell membrane to permanently alter its permeability to the extracellular environment. For example, a cell undergoing irreversible electroporation may exhibit structures of one or more pores that persist even after the electric field in its cell membrane is removed.

[0035] system Systems and devices configured to generate local ablation damage within tissue are disclosed herein. Generally, systems described herein for ablating tissue with high-voltage pulse waveforms may include an instrument tracking or location unit, an ECG recording or observation unit, a cardiac stimulator, and an ablation unit. The systems, methods, and practices described herein are applicable to synchronous or asynchronous ablation transmission. Furthermore, as described herein, systems and devices may be placed in the endocardium and / or epicardium to treat cardiac fibrillation.

[0036] Figure 1A is a schematic diagram of a mapping or location-finding system (10) (e.g., electromagnetic tracking) including a field generator (46) which includes a set of transmitters configured to generate an electromagnetic field. In embodiments including an impedance-based tracking system, the field generator (46) may include a set of electrode patches between subsets in which a potential difference is maintained over a frequency range. In embodiments including an electromagnetic tracking system (10), the field generator (46) may include a set of transmitter coils, each configured to generate a time-varying magnetic field. The generated electric or magnetic field (for an impedance-based tracking system or an electromagnetic tracking system, or for both types of systems, respectively) is typically received as a signal (voltage, current, or both) by a set of receivers (18) of a medical device (e.g., an ablation catheter, local ablation device (110)) to be tracked spatially. The received signal may be amplified by an amplifier (43) and then digitized and processed by one or more processors (42). The processors (42) may also be configured to control or drive the field generator (46). The processor (42) may be configured to estimate and / or determine the position and / or orientation of the medical device based on the received signal. The estimated position and orientation information may be displayed on an input / output device (48) (e.g., a graphic display (160)) in the form of a visual rendering of the spatially tracked device. In some embodiments, the input / output device (48) may allow the user to interact with the rendering (e.g., view it from different viewpoints) and / or visualize the device together with the biological structure of a constructed object or an imaged object.

[0037] Figure 1B is a schematic diagram of an electroporation system (100) including an ablation device (110), a mapping system (140), a pulse waveform generator (130), and optionally a cardiac stimulator (180). The ablation device (110) may include one or more electrodes (116) configured to generate a pulsed electric field for pulsed field ablation, for example, by irreversible electroporation. The ablation device (110) may include one or more receivers (118) configured to receive a signal (voltage, current, or both) from, for example, a field generator (146) of the mapping system (140), as will be further described below. In some embodiments, the ablation device (110) may also be an ablation catheter that can be introduced into the biological structure of the heart, for example, into the intracardiac space of the atrium. The distal portion of the ablation catheter may include electrodes (116) configured to transmit ablation energy (e.g., pulsed electric field energy) to nearby tissue. One or more electrodes (116) may be wired together or independently addressable. During operation (e.g., during ablation surgery), a voltage (e.g., a very short high-voltage pulse) may be applied to a selected subset of electrodes of the ablation device. Each electrode (116) may include an insulated wire configured to maintain a potential difference between approximately 200 V and approximately 3,000 V across its thickness without dielectric breakdown. In some embodiments, the electrodes (116) may include multiple electrodes that can be classified into one or more anode-cathode subsets, such as, but not limited to, a subset including one anode and one cathode, a subset including two anodes and two cathodes, a subset including two anodes and one cathode, a subset including one anode and two cathodes, a subset including three anodes and one cathode, a subset including three anodes and two cathodes, and so on. Further details and exemplary embodiments of the ablation device (110) are provided in the following drawings.

[0038] The ablation device (110) may be operably connected to a mapping system (140). The mapping system (140) may include components functionally and / or structurally similar to the ablation mapping system (10) described above with respect to Figure 1A. For example, the mapping system (140) may include a processor (142), memory (144), field generators (146), and input / output devices (148). The processor (142) may be any suitable processing device configured to execute and / or perform a set of instructions or codes. The processor (142) may be, for example, a general-purpose processor, a field-programmable gate array (FPGA), an application-specific integrated circuit (ASIC), a digital signal processor (DSP), etc. The processor may be configured to execute and / or perform processes and / or functions (not shown) related to the application process and / or other modules, the systems and / or networks associated therewith. The underlying technology of the device may be provided within various component types, such as metal-oxide-semiconductor field-effect transistors (MOSFETs), complementary metal-oxide-semiconductor (CMOS) technologies, bipolar technologies such as emitter-coupled logic (ECL), polymer technologies (e.g., silicon-conjugated polymers and metal-conjugated polymer metal structures), and a mix of analog and digital. The processor (142) may be configured to control a field generator (146) to generate one or more electric fields, magnetic fields, or electromagnetic fields. In some embodiments, the field generator (146) may include a set of electrode pads that are placed externally on the patient and can be used to generate an electric field. In some embodiments, the field generator (146) may include a set of transmitter coils configured to generate a time-varying magnetic field. The field generated by the field generator (146) may be received by a receiver (118). In some embodiments, the receiver (118) may be integrated into the ablation device (110). For example, electrodes on the device may sense the potential generated by the field generator (146).Furthermore, the receiver (118) may be positioned near, in the middle of, or adjacent to the ablation device (110), for example, on a probe or sensor located within the lumen of the ablation device (110). The processor (142) may be configured to determine the position, orientation and / or morphology of the ablation device (110) or other tracked device. For example, as further described in the following further embodiments, the processor (142) may process and / or analyze the data received by the receiver (118) to determine the position or orientation of the ablation device relative to the cardiac surface or cardiac wall, or the morphology (e.g., shape, deployment state) of the ablation device (110) when deployed in cardiac space. The processor (142) may be configured to determine a planned ablation area in the target biostructure, taking into account information relating to the patient, the ablation device (e.g., position, orientation and / or morphology), pulse waveform parameters, etc., as further described in the following embodiments of this example. While generating adjacent transmural damage, the processor (142) may be configured to determine the planned ablation area and / or the ablated area.

[0039] The memory (144) may be, for example, random access memory (RAM), a memory buffer, a hard drive, erasable programmable read-only memory (EPROM), electrically erasable read-only memory (EEPROM), read-only memory (ROM), flash memory, etc. The memory may store instructions for causing the processor (142) to perform modules, processes and / or functions such as field generation and / or location and orientation determination.

[0040] The input / output device (148) may be used to display information and / or to receive information from the user and / or other computer equipment (e.g., remote computing equipment operably connected to the electroporation system (100) by wired and / or wireless connections). In some embodiments, a processor (142) (or another processor) may be configured to generate information and control the input / output device (148) to display that information using, for example, a display, audio equipment, a projector, etc. The input / output device (148) may include a user interface, such as a display or audio equipment, which enables the display of output to the user and / or the reception of input from the user. In some embodiments, the input / output device (148) may display a visual representation of a specific biological structure (e.g., the biological structure of the heart) along with a visual representation of equipment being tracked within that biological structure (e.g., an ablation device (110)). During operation (e.g., during ablation surgery), the visual display may show the position, orientation, and / or morphology of the tracked instrument as it moves through the target biostructure, for example, immediately (e.g., within a few seconds). In some embodiments, the input / output device (148) may be used to receive input from the user specifying pulse waveform parameters (e.g., voltage, duration, delay time, etc.), characteristics or features, and / or other information that can help determine the planned ablation area of ​​the ablation instrument (e.g., type of ablation instrument, placement, etc.). In some embodiments, the input / output device (148) may be configured to display the planned ablation area and / or ablated area immediately, for example, during ablation surgery. In some embodiments, the input / output device (148) may be configured to display different features or components (e.g., structures on the surrounding biostructure, ablation instrument, planned ablation area and / or ablated area) using different markings, patterns, visual renderings, and / or colors to show them in configuration in superimposed with other components.

[0041] The pulse waveform generator (130) may be configured to generate an ablation pulse waveform for irreversible electroporation of tissue, such as a pulmonary vein orifice. For example, the pulse waveform generator (130) may generate a pulse waveform and transmit the pulse waveform to an ablation device (10) that generates a pulsed electric field capable of ablating tissue. In some embodiments, the pulse waveform generator (130) is configured to generate the ablation pulse waveform in synchronization with the cardiac cycle (e.g., within the normal refractory period of the atrial and ventricular pacing signals). For example, in some embodiments, the normal refractory period may begin substantially immediately (or with a very slight delay) following the pacing signal and last for about 250 milliseconds (ms) or a short duration thereafter. In some embodiments, the entire pulse waveform may be transmitted within this duration, while in other embodiments, a portion of the pulse waveform may be transmitted within this duration and the other portion may be transmitted during the normal refractory period of the subsequent cardiac cycle. In such embodiments, synchronization with the cardiac cycle may be achieved through the use of pacing or by appropriate gating of ablation transmission to R-wave detection based on ECG recording.

[0042] In some embodiments, the cardiac stimulator (180) may be configured to generate a pacing signal and provide the pacing signal to any pacing device (120) positioned near the target biostructure. The pacing device (120) may include a set of electrodes (122) that can receive the pacing signal and transmit the pacing signal to the biostructure of the heart, for example, to regulate the pace of the heart. Either or both of the atrial and / or ventricular pacing signals may be generated in or transmitted to the heart. In some embodiments, the pacing device (120) may be configured to sense and / or analyze patient information (e.g., cardiac signals) and provide this information to one or more of the mapping system (140) and / or pulse waveform generators (130) to further assist in controlling the operation of these devices (e.g., initiating or interrupting pulse waveform transmission, determining planned ablation areas and / or ablated areas, etc.).

[0043] In some embodiments, the cardiac stimulator (180) and the pulse waveform generator (130) may communicate with each other (e.g., to coordinate the timing of pulse waveform transmission and pacing signal transmission). In some embodiments, the cardiac stimulator (180) may be integrated with the pulse waveform generator (130) within a single signal control panel. In some embodiments, the cardiac stimulator (180) and the pulse waveform generator (130) may communicate with other devices, such as a mapping system (140) or telecomputing equipment, directly or through one or more networks, each of which may be of any type. A wireless network may refer to any type of digital network that is not connected by any kind of cable. However, a wireless network may be connected to a wired network to interact with the Internet, other carrier voice and data networks, business networks, and personal networks. Wired networks are typically transmitted via twisted-pair copper wire, coaxial cable, or fiber optic cable. There are many different types of wired networks, including wide area networks (WANs), city-scale networks (MANs), local area networks (LANs), campus area networks (CANs), global area networks (GANs) such as the Internet, and virtual private networks (VPNs). Hereinafter, "network" refers to any combination of interconnected wireless, wired, public, and private data networks that are typically interconnected via the Internet, providing integrated network construction and information access solutions.

[0044] In some embodiments, the pulse waveform generator (130) and / or cardiac stimulator (180) may be operably coupled to a mapping system (140), so that information regarding pulse waveforms, pacing signals and / or sensed signals (e.g., sensed cardiac signals from a pacing device (120)) may be provided to the mapping system (140) for, for example, to assist in device location confirmation and / or scheduled ablation decisions. In some embodiments, the mapping system (140) and / or processor associated with the pulse waveform generator (130) and / or cardiac stimulator (180) may be integrated into one or more controllers capable of controlling the respective components of these devices.

[0045] Although not shown, the cardiac stimulator (180) and pulse waveform generator (130) may include one or more processors similar to a processor (142), which may be any suitable processing device configured to execute or perform a set of instructions or codes.

[0046] Although not shown, the cardiac stimulator (180) and pulse waveform generator (130) may include one or more memories or storage devices similar to memory (144). The memory may store instructions for one of the processors of the cardiac stimulator (180) and pulse waveform generator (130) to perform modules, processes and / or functions such as pulse waveform generation and / or cardiac pacing.

[0047] Figures 2A and 2B are schematic diagrams of embodiments of ablation devices (e.g., local ablation devices). Figure 2A shows a catheter device (200) configured to receive a pulse waveform and generate an electric field for ablation of cardiac tissue. The ablation device (200) may include an outer catheter axis (210), an inner catheter axis (220), a set of splines (230), and electrodes (232, 234, 236, 238). The outer catheter axis (210) may include a distal end where the proximal ends of the set of splines (230) (four splines in Figures 2A and 2B) are symmetrically connected to the inner catheter axis (220) within the lumen of the outer catheter axis (210). In some embodiments, the inner catheter axis (220) may be configured to extend beyond the outer catheter axis (210). The distal end of the spline set (230) may be connected to the distal end of the internal catheter shaft (220) by a distal cap (240), as shown in Figure 2B. In some embodiments, the internal catheter shaft (220) may be operated (e.g., deployed, retracted) using a control mechanism (e.g., actuator) that can transition the spline set (230) (e.g., the spline basket) to bend or change its shape, for example from a substantially linear shape to a bulb shape, as shown in Figure 2A, such as a knob or rocker switch (not shown) in the catheter handle. The spline set (230) may be configured to have multiple forms of different shapes and diameters, from undeployed (e.g., compressed in the external catheter lumen, or in a stopped or unrestricted state) to partially deployed and fully deployed. That is, the spline set (230) may be deployed over a range of continuous larger deployments that extend the maximum diameter of the deployed shape of the spline (230) over the range of deployed shapes or forms. For example, a set of splines (220) may transition to a semi-unfolded state having a diameter between the diameter of the un-unfolded state and the diameter of the fully-unfolded state.

[0048] In some embodiments, one or more splines (230) may include one or more sets of proximal electrodes (232, 234) and distal electrodes (236, 238). In some embodiments, one spline in the set of splines (230) may include about 1 to about 8 proximal electrodes (232, 234) and about 1 to about 8 distal electrodes (236, 238). In some embodiments, the instrument (200) may include about 2 to about 12 splines, including all ranges and sub-values ​​in between.

[0049] In some embodiments, the ablation device (e.g., ablation device(110, 200)) may be incorporated into a receiver (e.g., receiver(118)) implemented as an electromagnetic tracking sensor for tracking the position or orientation of the ablation device. Along with the calculations of the device configurations described herein, electromagnetic location data can provide a refined (e.g., improved) spatial location of all device electrodes. In such embodiments, the ablation device may be used to travel through different locations within the heart chambers while collecting location data and / or cardiac data (e.g., recorded using one or more electrodes of the ablation device), and thus may be used to construct a visual representation of the surface biostructure of the heart chambers.

[0050] Furthermore, or in some embodiments, the ablation catheter (e.g., ablation device (110)) may include a receiver implemented as an electrode configured to measure voltage and / or current induced by an electric field generated by a set of surface patches. In such embodiments, the set of surface patches may be configured to generate electric fields in multiple planes, such that voltage and / or current signals are measured by the electrodes of the ablation catheter (or impedance is estimated using such measurements).

[0051] While a basket-shaped ablation device (110) is shown in Figures 2A and 2B, it should be understood that ablation devices suitable for the applications described herein may have different shapes from those shown in Figures 2A and 2B. For example, other example ablation devices may include a linear local ablation catheter in which a set of electrodes is arranged along the distal portion of the catheter axis. A suitable example of a linear ablation catheter is described in U.S. Provisional Patent Application No. 62 / 863,588, “System, Device and Method for Local Ablation,” filed June 19, 2019, whose disclosure is incorporated herein by reference. The set of electrodes may include a set of distal electrodes and a set of proximal electrodes arranged on a single linear axis. In some embodiments, the set of distal electrodes may include a distal cap electrode. The distal device shape can generally be characterized by a set of parameters including, for example, the length and diameter of the electrodes as well as a set of separation distances between adjacent electrodes. Similar to what has been described above with respect to the ablation catheters shown in Figures 2A and 2B, the distal device shape, or electrode shape in general, can be characterized by a set of geometric parameters for a predetermined geometric arrangement of electrodes on the local ablation catheter device.

[0052] method Methods for determining the planned ablation area during tissue ablation surgery performed in or near one or more cardiac chambers using the systems and instruments described herein are also described herein. In embodiments, the cardiac chamber may be the left atrium and may include the associated pulmonary veins, but the instruments and methods described herein may also be used in other cardiac chambers. Generally, one or more catheters may be advanced through the vascular system to the target site in a minimally invasive manner. For example, an ablation device may be advanced through the vascular system via a deflectable sheath on a guidewire. This sheath may be configured to be deflectable and may be used to advance the local ablation catheter through the vascular system and one or more predetermined targets (e.g., pulmonary vein orifices). A dilator may be advanced on a guidewire and may be configured to create and dilate a transseptal orifice during and / or before use. Methods described herein include introducing and positioning an ablation device (e.g., ablation device (110, 200)) in contact with one or more pulmonary vein orifices or cavity areas. The pacing signal may be transmitted to the heart using a cardiac stimulator (e.g., cardiac stimulator (180)) and / or cardiac activity may be measured. The spatial characteristics of the ablation device and tissue (e.g., location, orientation, morphology) may be determined and used to generate a tissue map for planned ablation areas and / or display. A pulse waveform may be transmitted by one or more electrodes of the ablation device to ablate the tissue. In some embodiments, the ablation energy may be transmitted in sync with cardiac pacing. In some embodiments, the voltage pulse waveforms described herein may be applied during the refractory period of the cardiac cycle to avoid disruption of the sinus rhythm of the heart. A tissue map including ablated tissue and planned ablation areas may be updated immediately on the display as the device moves through the tissue and additional pulse waveforms are transmitted to the tissue.

[0053] A pulse waveform may be generated and transmitted to one or more electrodes of the device to ablate tissue. In some embodiments, the pulse waveform may be generated in sync with the cardiac pacing signal to avoid disruption of the cardiac sinus rhythm. In some embodiments, the electrodes may be configured in an anode-cathode subset. Furthermore, or alternatively, the pulse waveform may include multiple levels of hierarchy to reduce the total amount of energy transmitted, as described, for example, in International Patent Application No. PCT / US2019 / 031135, “System, apparatus and method for transmitting ablation energy to tissue,” filed on May 7, 2019. This disclosure is incorporated herein by reference. In some embodiments, the ablation devices described herein (e.g., ablation devices (110, 200)) may be used for epicardial and / or intracardiac ablation. Examples of suitable ablation catheters are described in International Patent Application No. PCT / US2019 / 014226, incorporated above by reference.

[0054] Figure 9A shows an exemplary method (900) of tissue mapping and ablation according to embodiments described herein. Method (900) may be carried out by any of the mapping and / or ablation systems described herein, including, for example, system (10, 100). Specifically, method (900) may be carried out by a processor or controller associated with the mapping system or system (e.g., processor (42, 142)). Method (900) includes introducing an ablation device (e.g., ablation device (110, 200)) into a cardiac chamber (e.g., intracardiac space) so as to be in contact with or near cardiac tissue in (902). The ablation device may be advanced to a predetermined location, e.g., near the tissue surface, in (904). For example, the ablation device may be positioned near or in contact with the inner radial surface of a lumen (e.g., one or more pulmonary vein orifices) for mapping and / or tissue ablation. The ablation device may optionally transition to one of several forms (e.g., deployed states) in (906). For example, the ablation device may transition from a fully undeployed state to a fully deployed state or any intermediate state (e.g., a partially deployed state). In some embodiments, the ablation device may include a set of splines, each of which includes a set of proximal electrodes and a set of distal electrodes, so that the set of splines includes multiple proximal electrodes and multiple proximal electrodes as a whole. In some embodiments, the user may control an actuator (e.g., a handle) to transition the set of splines between different deployed states.

[0055] In some embodiments, spatial information relating to the ablation device and tissue may be determined in (908). For example, a signal may be received by a receiver (e.g., a sensor, electrode, etc.) connected to or integrated with the ablation device in accordance with the electric or magnetic field generated by a field generator. Data indicating the signal received by the receiver may be received by a processor (e.g., processor (42, 142)) capable of further processing and / or analyzing such information. Based on such analysis, spatial information of the ablation device (e.g., position, orientation, morphology) may be determined by the processor.

[0056] For example, such an analysis may involve determining one or more geometric parameters that characterize the distal end of the ablation device. In some embodiments, using a known distal shape of the distal portion of the ablation device (e.g., a local ablation catheter), the shape of the ablation device may be characterized by a set of geometric parameters for a given form of spline. For example, as shown in Figure 3, the center of the proximal electrode (not shown for clarity) on each spline lies on the proximal circle (300), and the center of the distal electrode (not shown for clarity) on each spline lies on the distal circle (320). The proximal and distal circles (300, 320) lie in parallel planes and are separated by a distance b(340). The proximal circle (300) has a diameter d1(310), and the distal circle (320) has a diameter d2(330). The shape of the distal portion of the ablation device can be characterized by these parameters.

[0057] In some embodiments, the impedance-based location system may be configured to generate the spatial coordinates of the proximal and distal electrodes of the ablation device. Conventional impedance-based location systems may be prone to errors due to tissue heterogeneity. As described herein, the location system may generate an improved (or refined) spatial coordinate estimation of the distal portion of the local ablation device. Considering the coordinates of the distal electrodes of the ablation device obtained from the impedance-based location system, the center of the proximal electrode on each spline can be determined. From this set of centers on each spline, the center of those centers x1 of the proximal electrodes can be determined. Center x1 can be used to calculate the center of the best-fit circle C1 (corresponding to the proximal electrode), which has a diameter d1 and may be calculated, for example, using least-squares fitting. Similarly, the center of the distal electrode on the set of splines may be determined, and the center of the centers x2 of the distal electrode can be determined. Center x2 can be used to calculate the center of the best-fit circle C2 (corresponding to the distal electrode), which has a diameter d2. The diameter d1 of central x1 and the diameter d2 of central x2 can be determined. The distance b between central x1 and x2 can be calculated.

[0058] The morphology of the ablation device may be determined based on diameter d1, diameter d2 and distance b, and the orientation of the ablation device may be defined using centers x1 and x2. Specifically, each is a parameter {d 1,i d 2,i , b i} and the known deployment form of the corresponding ablation device (labeled by index i) {F i Considering the set of}, the closest form {F * i} is, for example, the minimum error or cost S using [Number 1]. i It may be calculated by finding the form using [a specific method / tool].

[0059]

number

[0060] In embodiments where the local ablation catheter device does not incorporate an electromagnetic sensor, the device orientation can be partially defined by a unit vector v as shown in [Equation 2].

[0061]

number

[0062] Furthermore, the unit vector w = (p1-x1) / |p1-x1| from the center x1 to the center p1 of the proximal electrode on the reference spline (e.g., the first spline), together with v, can completely define the instrument orientation. The instrument configuration and instrument orientation obtained above can provide an improved spatial location for each instrument electrode.

[0063] Optionally, the surface biostructure of the cardiac chambers may be constructed (e.g., simulated) using the instrument location and / or tracking systems described herein. For example, as shown in Figure 9B, the local catheter instrument may be advanced to different locations within the cardiac chambers in (950), and electrodes in contact with the tissue surface may be identified at any time in (952) (e.g., based on ECG amplitude, timing, or other criteria) based on intracardiac ECG recordings from cardiac electrodes. After identifying these electrodes in contact with the tissue surface in (954), the individual electrode locations of these electrodes may be identified based on the instrument shape and sensing location as described above with reference to Figures 3 and 9A. Electrode locations may be acquired as points for a biostructure map or surface reconstruction. As the instrument is advanced to various locations on the surface of the cardiac lumen, a very large number of such points (e.g., electrode locations in contact with the tissue surface) or point clouds may be acquired to form a basis for a tissue map. In some embodiments, a tissue map may be generated in (956). For example, a point cloud containing multiple points may be generated in (954), where each of the multiple points corresponds to the location of an electrode identified at a different location among multiple locations. A map of the tissue surface can be constructed using a point cloud as shown in (956).

[0064] A portion of such a display (e.g., an tissue map) is shown in Figure 10. In Figure 10, a surface reconstruction (1000) of the intracardiac biostructure is constructed using points (1020) that indicate the locations of electrodes that came into contact with the tissue surface at multiple locations where the ablation device advanced. Based on these points, a surface rendering including light and shadow effects, perspective projection, etc., may be generated using surface triangulation or a mesh.

[0065] In some embodiments, a biostructural map of the cardiac chambers may be acquired using other equipment (e.g., imaging equipment), and the biostructural map may be provided to a mapping and ablation system as described herein. In such embodiments, the ablation equipment may optionally be used to verify the accuracy of the biostructural map, for example, using the method shown in Figure 9B. Alternatively, paragraphs 950-956 may be excluded, and the systems described herein may rely on biostructural maps provided by external sources.

[0066] Referring back to Figure 9A, method (900) further includes determining the planned ablation area of ​​the ablation device in (912) and indicating the planned ablation area (e.g., visually on a display) in (914). Optionally, a portion of the ablation device may also be indicated along with the planned ablation area. For example, an output device may display a visual representation of the ablation device on a map of the tissue surface based on the location and orientation of the ablation device. Figure 10 shows the distal portion (1050) of a local ablation catheter device near or on the inner cardiac surface (1010), including a basket of splines on that surface. Figure 10 further shows the planned ablation area (1030) displayed on a surface reconstruction (1000) corresponding to the location of the local ablation device on the inner cardiac surface. The ablation area (1030) has a center (1032) which may be located as described herein. Figures 11 and 12 show ablation devices (1150, 1250) with determined positions and orientations relative to tissue surface maps (1110, 1210), respectively. Similarly, Figure 17 further shows the planned ablation area (1730) displayed on a surface reconstruction (1700) corresponding to the location of the linear local ablation device on the inner cardiac surface (1710). The ablation area (1730) has a center (1732) that may be located as described herein. Figures 18 and 19 show linear ablation devices (1850, 1950) with determined positions and orientations relative to tissue surface maps (1810, 1910), respectively.

[0067] In some embodiments, the planned ablation area may be determined by a processor (e.g., processor(42, 142)) based on the position and orientation of the ablation device, as further described below. For example, the planned ablation area may be determined by determining the shortest distance from the ablation device to the tissue surface, identifying a set of points from a plurality of points that are within a predetermined distance from the distal end of the ablation device when the shortest distance is less than a predetermined value, determining the center of the set of points, determining a local tangent plane to the surface extending through the center, and determining the center of the planned ablation area, which represents the location of the tissue surface with the maximum ablation depth (e.g., the location of the center of the surface of the ablation device), based on the position and orientation of the ablation device with respect to the local tangent plane. Furthermore, the planned ablation area may be based on one or more pulse waveform parameters (e.g., pulse voltage, interval, delay, number, number of pulse groups, etc.) that can modify, for example, the size and depth of the planned ablation area.

[0068] To illustrate an example of determining a planned ablation region, FIGS. 11 and 18 show an ablation device (1150, 1850), such as a local ablation catheter and a linear local ablation catheter, respectively, on the endocardial surface represented by a point cloud including a number of points each containing a point (1120, 1820). As shown, the ablation device (1120) may be in an inclined orientation state and may be partially deployed (similar to FIGS. 5 and other drawings further described below). The ablation device (1850) may be in an inclined orientation state similar to the ablation device (1120). The distal tips (1152, 1852) of the devices are also shown in FIGS. 11 and 18. Based on the current location of the distal tips (1152, 1852) and if the shortest distance from the device to the endocardial surface is less than a predetermined separation, a set of local points within a point cloud within a predetermined distance D from the device tip can be identified by the points (1120, 1820). For example, the predetermined separation may be less than about 4 mm and the predetermined distance may be less than about 3 cm. Although other points in the point cloud are not shown, it may be understood that the point cloud may include additional points (not shown) that are not within the set of local points.

[0069] The center (1122, 1822) of this set of local points can be calculated. A local tangent plane (1110, 1810) to the surface passing through the local center (1122, 1822) is determined. For example, such a plane can be determined by solving an optimization problem. If the set of local points (1120, 1820) is y i and the center (1122, 1822) is x c and the unit normal of the local tangent plane (1110, 1810) is n, the distance of each local point to the tangent plane (1110, 1810) is given by [Equation 3].

[0070]

Equation

[0071] The cost function can be defined as the sum of the squared distances as in [Equation 4].

[0072]

number

[0073] Here, matrix A is defined as the sum of cross products (beyond the local set of points).

[0074]

number

[0075] In some embodiments, it is desirable to find the normal n to the local tangent plane that minimizes cost C. Furthermore, since n is the unit normal, constraints n T This satisfies n=1. By introducing an appropriate Lagrange method λ, this leads to a constrained cost function.

[0076]

number

[0077] In some embodiments, C′ can be minimized with respect to n and λ. For example, the eigenvalue equation can be derived by performing this minimization.

[0078]

number

[0079] The unit eigenvector n corresponding to the smallest eigenvalue of matrix A. * This is the desired solution for the normal to the local tangent plane (1110, 1810). Thus the local tangent plane (1110, 1810) is determined.

[0080] Once the local tangent plane is known, the ablation area center (1130, 1830) can be determined based on known characteristics of the ablation area (and its center) that depend on the orientation of the distal device shape relative to the local tangent plane and / or the unfolded configuration. Subsequently, the planned ablation area can be rendered within the local tangent plane, taking into account the device positioning and placement on the intracardiac surface. In some embodiments, the planned ablation area may be projected onto the surface rendering itself, or it may be shown as one or more of a surface, a colored patch, or other graphic indicators (e.g., projected or rendered in a tissue map in (914)).

[0081] The planned ablation areas may be indicated in (914) in a variety of ways. For example, a map of the tissue surface and a visual representation of the planned ablation areas in the map of the tissue surface may be displayed by an output device operably connected to the processor (e.g., input / output devices (48, 148) or an output device connected to an external computing device).

[0082] In some embodiments, the planned ablation area can be determined (e.g., by a processor including processors (42, 142), etc.) by identifying the electrode that contacts the tissue surface from among a plurality of electrodes (e.g., using ECG data as described above), identifying the planned ablation area shape from a plurality of planned ablation area shapes based on the position and orientation of the ablation device, and generating a planned ablation area based on the planned ablation area shape, with a center representing the location of the tissue surface having the maximum ablation depth (e.g., the location of the center of the surface of the ablation area) at a location corresponding to the electrode location. For example, Figure 4 provides an illustration of an ablation device (430) (e.g., a local ablation catheter) in contact with a tissue region (410), and a simulated or planned ablation area (440) generated by pulsed field ablation. The tissue region (410) is in contact with the blood pool (420) at the tissue wall surface or blood-tissue interface (412) where the catheter device (430) in the shape of a partially deployed local ablation catheter is positioned. In Figure 4, the distal portion of the device has a spline basket shape similar to that in Figures 2A-2B, and the device (430) engages with respect to the blood-tissue interface (412) in a vertical or normal orientation. The device (430) may be configured to generate a pulsed electric field (indicated by the field shape (441)) that can generate a planned ablation area (440) by irreversible electroporation. The planned ablation area (440) is concentrated (or has maximum depth) at a tissue surface or interface location (442) corresponding to the location of the distal tip of the catheter device (430).

[0083] The shape, size, and / or orientation of the planned ablation area (440) may be based on the spatial characteristics or shape of the ablation device. For example, a linear local device may have an ablation area whose shape and size may differ from that of a typical local ablation device. In some embodiments, the ablated area generated by the ablation device (430) may be recorded for the ablation device (430) when the device is present in multiple positions, orientations, and / or forms relative to the tissue surface, and the shape obtained from the generated ablated area may be recorded and stored to further mention that it generates a planned ablation area. In some embodiments, such an ablated area may be generated in an experimental environment, for example, using a subject / preclinical animal model.

[0084] Further examples of planned ablation areas are shown in Figures 5-8 and 14-16, illustrating modifications to planned ablation areas depending on the spatial characteristics of the ablation device, and are described with reference to Figures 5-8 and 14-16. Figure 5 provides an illustration of the ablation device (530) in contact with a tissue region (510) and a simulated ablation area or planned ablation area (540) generated by pulsed electric field ablation. The tissue region (510) is in contact with the blood pool at the tissue wall surface or blood-tissue interface (512) where the catheter device, in the shape of a partially deployed local ablation catheter, is positioned. In Figure 5, the distal portion of the device has a spline basket shape as already shown in Figures 2A-2B, and the device engages with the tissue interface in an oblique orientation relative to the blood-tissue interface (512). The device (530) may be configured to generate a pulsed electric field (indicated by a field outline (541)) that can generate the planned ablation area (540) by irreversible electroporation. In this case, the planned ablation area (540) is concentrated at a tissue surface or interface location (542) corresponding to the location of the most distal electrode of the catheter device (530) closest to the tissue wall interface (512).

[0085] Figure 6 provides an illustration of an ablation device (630) in contact with a tissue region (610) and a simulated or planned ablation area (640) generated by pulsed electric field ablation. The tissue region (610) is in contact with the blood pool at the tissue wall surface or blood-tissue interface (612) where the catheter device, which is in the shape of a partially deployed local ablation catheter, is positioned. In Figure 6, the distal portion of the device has a spline basket shape similar to that in Figures 2A-2B, and the device (630) engages with the tissue interface in a parallel orientation to the blood-tissue interface (612). The device (630) may be configured to generate a pulsed electric field (indicated by a field shape (641)) that can generate the planned ablation area (640) by irreversible electroporation. The ablation area (640) is, in this case, concentrated at the tissue surface or interface location (612) corresponding to the location just adjacent to the nearest edge of the distal electrode of the catheter device (630) closest to the tissue wall interface (612), as shown in Figure 6 (or having the maximum depth).

[0086] Figure 7 provides an illustration of an ablation device (730) in contact with a tissue region (710) and a simulated or planned ablation area (740) generated by pulsed electric field ablation. The tissue region (710) is in contact with the blood pool at the tissue wall surface or blood-tissue interface (712) where the catheter device (730), in the shape of a partially deployed local ablation catheter, is positioned. In Figure 7, the distal portion of the fully deployed device (730) has a spline basket shape, and the device engages with the tissue interface (712) in a state perpendicular or normal orientation to the blood-tissue interface (712). The device (730) may be configured to generate a pulsed electric field (indicated by a field outline (741)) that can generate the planned ablation area (740) by irreversible electroporation. The ablation area (740) is concentrated (or has maximum depth) at the tissue surface or interface location (712) corresponding to the location of the distal tip of the catheter device (730), as shown in Figure 7.

[0087] Figure 8 provides an illustration of an ablation device (830) in contact with a tissue region (810) and a simulated or planned ablation area (840) generated by pulsed electric field ablation. The tissue region (810) is in contact with the blood pool (820) at the tissue wall surface or blood-tissue interface (812) where the catheter device (830), which is in the shape of a partially deployed local ablation catheter, is positioned. In Figure 8, the distal portion of the fully deployed device (830) has a spline basket shape, and the device engages with the tissue interface (812) in an oblique orientation relative to the blood-tissue interface (812). The device (830) may be configured to generate a pulsed electric field (indicated by a field shape (841)) that can generate the planned ablation area (840) by irreversible electroporation. The ablation area (840) is concentrated in the tissue surface or interface location (842) corresponding to the location on the tissue surface closest to the distal tip of the catheter device (730), as shown in Figure 8 (or having the maximum depth).

[0088] Figure 14 provides an illustration of an ablation device (1430) (e.g., a linear local ablation catheter) in contact with a tissue region (1410) and a simulated or planned ablation area (1440) generated by pulsed electric field ablation. The tissue region (1410) is in contact with the blood pool (1420) at the tissue wall surface or blood-tissue interface (1412) where the linear catheter device (1430) is positioned. In Figure 14, the distal portion of the device (1430) engages with the tissue interface (1412) in a state perpendicular or normal orientation to the blood-tissue interface (1412). The device (1430) may be configured to generate a pulsed electric field that can generate the planned ablation area (1440) by irreversible electroporation. The planned ablation area (1440) is, in this case, concentrated at the tissue surface or interface location (1442) corresponding to the location of the distal tip of the catheter device (1430) (or having the maximum depth).

[0089] The linear local ablation apparatus (1430) may include a set of annular electrodes positioned on the distal portion of the apparatus (1430). For example, the apparatus (1430) may include a set of proximal electrodes (1432) and a set of distal electrodes (1434). In some embodiments, the apparatus (1430) may include a distal cap electrode (1436) (e.g., the most distal electrode). A set of electrode parameters defining the shape of the electrodes may include one or more of the electrode length and diameter and the distance between adjacent electrodes. In some embodiments, the linear ablation apparatus (1430) may include one or more sensors. For example, the distal portion of the apparatus (1430) may include sensors configured to receive electromagnetic signals for measuring one or more of the position and / or orientation of the distal portion of the apparatus (1430), as will be described in further detail herein.

[0090] The shape, size, and / or orientation of the planned ablation area (1440) may be based on the spatial characteristics or shape of the ablation device. For example, a linear local device may have an ablation area whose shape and size may generally differ from that of a local ablation device having a basket shape. In some embodiments, the ablated area generated by the ablation device (1430) may be recorded for the ablation device (4130) when the device is present in multiple positions, orientations, and / or forms relative to the tissue surface, and the shape obtained from the generated ablated area may be recorded and stored to indicate that it generates the planned ablation area. In some embodiments, such ablated areas may be generated in an experimental environment, for example, using a subject / preclinical animal model. Furthermore, or alternatively, the shape of such ablated area may be derived from a computational model.

[0091] Figure 15 provides an illustration of an ablation device (1530) in contact with a tissue region (1510) and a simulated or expected ablation area (1540) generated by pulsed electric field ablation. The tissue region (1510) is in contact with the blood pool (1520) at the tissue wall surface or blood-tissue interface (1512) where the catheter device (1530), which has the shape of a linear local ablation catheter, is positioned. In Figure 15, the distal portion of the device engages with the tissue interface in an oblique orientation relative to the blood-tissue interface (1512). The device (1530) may be configured to generate a pulsed electric field that can generate the intended ablation area (1540) by irreversible electroporation. The intended ablation area (1540) is concentrated at a tissue surface or interface location (1542) that approximately corresponds to the location of the most distal electrode of the catheter device (1530) closest to the tissue wall interface (1512) (or has the maximum depth).

[0092] Figure 16 provides an illustration of an ablation device (1630) in contact with a tissue region (1610) and a simulated or expected ablation area (1640) generated by pulsed electric field ablation. The tissue region (1610) is in contact with the blood pool (1620) at the tissue wall surface or blood-tissue interface (1612) where the linear catheter device is positioned. In Figure 16, the distal portion of the device (1630) engages with the tissue interface (1612) in an orientation substantially parallel to the blood-tissue interface (1612). The device (1630) may be configured to generate a pulsed electric field that can generate the expected ablation area (1640) by irreversible electroporation. The ablation area (1640) is concentrated at a tissue surface or interface location (1612) corresponding to a location just adjacent to the nearest edge of the distal electrode of the catheter device (1630), as shown in Figure 16.

[0093] As shown in Figures 4-8 and 14-16, the ablation areas generated by the pulsed electric field may be concentrated at tissue surface locations (generally the inner surface of cardiac tissue adjacent to the blood pool) and may vary with respect to the device shape (e.g., generally based on the device's deployment range and / or orientation of the device to local tissue interfaces). In some embodiments, the planned transmural ablation areas (where the tissue ablation areas extend intermittently across the thickness of the tissue from the inner side of the heart to the epicardial side of the tissue) may exhibit similar patterns.

[0094] In some embodiments, the planned shape of the ablation area (including the approximate center of the ablation area) is estimated, and the representation of the ablation area, e.g., the minimum planned ablation area, can be provided graphically when a map of the tissue surface biostructure is available, depending on either or both of the instrument deployment and the orientation of the instrument relative to the local tissue wall.

[0095] For Figure 9A, after determining and displaying the planned ablation area, method (900) may wait for confirmation (e.g., from the user or a computing device) regarding whether or not to deliver the ablation pulse. For example, the user can view the displayed planned ablation area and determine whether the planned ablation area is appropriate for treatment or requires further adjustment. The user may provide input (e.g., by an input / output device (48, 148)) indicating whether or not to proceed with ablation of the tissue. Alternatively, a computing device (e.g., a processor (42, 142)) may be programmed to evaluate the planned ablation area and determine whether or not to proceed with ablation of the tissue based on whether the planned ablation area meets certain parameters (e.g., a specified amount of overlap with a previously ablated area to form a continuous injury). If ablation should not be continued (e.g., because the planned ablation area requires adjustment and therefore repositioning and / or reconfiguration of the ablation device) (916-no), the process may return to (904). In such cases, the ablation apparatus is repositioned at (904) and / or reconfigured at (906), and the spatial characteristics of the apparatus may be re-evaluated to determine the planned ablation areas after such adjustments to the ablation apparatus. In some embodiments, the planned ablation areas may be immediately updated and displayed, for example, on a tissue map of the target tissue surface. When ablation is continued (916-yes), the tissue is ablated by the ablation apparatus at (918), and the ablated areas may be displayed (for example, on a tissue map).

[0096] In some embodiments, a mapping system (e.g., mapping system (10, 140)) separate from a signal generator (e.g., pulse waveform generator (130)) may transmit a signal to the signal generator to cause the signal generator to generate a pulse waveform to be transmitted to the ablation device, so that the ablation device generates an electric field that generates ablated areas corresponding to the planned ablation areas. In some embodiments, the mapping system may be integrated with the signal generator, and based on the decision to continue ablation, the mapping system may generate a pulse waveform and deliver it to the ablation device. As will be described in more detail herein, Figures 12 and 13 show ablation areas (1220, 1222, 1224, 1320, 1322, 1324, 1326) on a tissue surface (1210, 1310).

[0097] In some embodiments, the systems, apparatus and methods described herein may be based on ablated areas on a planned ablation area (e.g., having an ablated area similar to the planned ablation area). Furthermore, after ablation of tissue in (918), such systems, apparatus and methods may indicate ablated areas by changing the markings of the planned ablation area to indicate that the area has been ablated. For example, the planned ablation area may be visually indicated using a first set of marks or by coloring before ablation, and the ablated area may be visually indicated using a second set of marks or by a different coloring than the first set of marks before ablation.

[0098] In some embodiments, the system, apparatus and method may use further methods for detecting the ablated tissue area (e.g., using signals (e.g., impedance) received by one or more sensors (e.g., electrodes (116, 122)) or using external equipment). In such embodiments, the system, apparatus and method may be further adapted to determine the planned ablation area based on the detected ablated area (e.g., model, algorithm). For example, future determination of the planned ablation area can be improved by using, for example, an analysis of the comparison between the planned ablation area and the actual ablated area, along with parameters related to the tissue and / or ablation equipment (e.g., tissue thickness, tissue type, ablation equipment shape and / or placement, etc.) that may have caused the difference between the planned ablation area and the actual ablated area.

[0099] In (920-No), if the transmission of the ablation pulse is not completed by the ablation device (for example, when generating a continuous damage line using the ablation device as further described with reference to Figure 12), the process may return to (904), so the ablation device may be moved to another location and further ablation pulses may be transmitted. For example, when the ablation device is in a second location different from the first location, the receiver may receive data indicating a signal depending on the electric or magnetic field. The second position and second orientation of the ablation device may then be determined based on the data indicating a signal. The second planned ablation area of ​​the ablation device on the tissue surface may be determined based on the second position and second orientation of the ablation device.

[0100] The visual representation of the ablated areas may be displayed by the output device using a first set of marks, and the visual representation of the second planned ablation area may be displayed using a second set of marks different from the first set of marks. For example, as will be further described below, Figure 12 shows the visual representation of a first set of three ablated areas (1220, 1222, 1224) indicated by a first set of marks (e.g., solid lines) and a second planned ablation area (1230) indicated by a second set of marks (e.g., dashed lines).

[0101] In some embodiments, the first and second ablated areas may form part of a continuous injury in the tissue surface. For example, a signal generator may be activated to generate a pulse waveform for transmission to the ablation device, so that when the second planned ablation area has a larger area than a predetermined value that overlaps with the ablated area, the ablation device generates a second ablated area corresponding to the second planned ablation area. Figures 12 and 19 illustrate the process of generating a continuous injury line using the systems and devices described herein (e.g., basket ablation devices, linear ablation devices). The distal device shape of a local ablation device (1250, 1950) is shown on the inner cardiac surface (1210, 1910). The estimated ablation areas (1230, 1930) of the current placement of the device (1250, 1950) are shown as dashed contours on the inner cardiac surface (1210, 1910) in Figures 12 and 19. In Figures 12 and 19, the previously ablated areas (1220, 1222, 1224, 1920, 1922, 1924) are indicated by solid outlines. If this arrangement and planned ablation areas have a proper overlap with the previously ablated areas (1220, 1222, 1224, 1292, 1922, 1924) as defined by the user, the user may ablate the current equipment arrangement and mark the planned areas as ablated areas, and the display may update to render dashed outlines as solid outlines indicating that ablation is complete, as shown by the ablated areas (1326, 2026) in Figures 13 and 20, respectively. In some embodiments, various other renderings of ablated and planned ablated areas may be used to visually distinguish the area types, and include, but are not limited to, different and distinguishable colors, outlines, shading, transparency, or various graphical rendering methods for rendering a visual distinction between planned ablated areas and already ablated areas.

[0102] This process may be continued to generate a series of overlapping ablated areas for the generation of a continuous injury line. In some embodiments, the size of the indicated planned ablation area may be shown to be smaller than the size of the area simulated or determined preclinically as a way to indicate closer placement of adjacent ablations to ensure proper injury overlap. Furthermore, the shape and size of the surface rendering of the ablation area generally depend on the instrument orientation and / or instrument deployment state relative to the local tangent plane. In some embodiments, the shape and size of the indicated ablation area may depend at least in part on the distal instrument shape. For example, a linear local ablation instrument may correspond to ablation areas with shapes and sizes that generally differ from those of local ablation instruments with basket shapes.

[0103] Once the ablation is complete (920-yes), the ablation device may be withdrawn from the cardiac chamber and the patient (992). The examples and drawings in this disclosure provide typical purposes and deviations, as well as examples of variations such as the number of splines and electrodes. In other words, it should be understood that various local ablation devices, such as linear ablation catheters, can be constructed and developed in accordance with the teachings herein without departing from the scope of the present invention.

[0104] Where used herein, the terms “about” and / or “approximately” refer to numbers and / or ranges that are close to the listed numbers and / or ranges when used in combination with numbers and / or ranges. In some examples, the terms “about” and / or “approximately” may mean within ±10% of the listed values. For example, in some examples, “about 100 [units]” may mean within ±10% of 100 (e.g., from 90 to 110). The terms “about” and / or “approximately” may be used interchangeably.

[0105] Some embodiments described herein relate to computer memory products having a non-temporary computer-readable medium (which may also be referred to as a non-temporary processor-readable medium) having instructions or computer code thereon for performing various computer implementation operations. The computer-readable medium (or processor-readable medium) is non-temporary in the sense that it does not contain inherently temporary propagating signals (e.g., propagating electromagnetic waves carrying information on a transmitting medium such as space or cable). The medium and computer code (which may also be referred to as code or algorithms) may be designed and configured for a particular purpose or for other purposes. Examples of non-temporary computer-readable mediums include, but are not limited to, magnetic storage media such as hard disks, floppy disks and magnetic tapes; optical storage media such as compact disks / digital video discs (CDs / DVDs), compact disk read-only memory (CD-ROMs) and holographic devices; magneto-optical storage media such as optical disks; and hardware specifically configured to store and execute program code, such as carrier signal processing modules, application-specific integrated circuits (ASICs), programmable logic circuits (PLDs), read-only memory (ROMs) and random access memory (RAM) devices. Other embodiments described herein relate to computer program products, which may include, for example, instructions and / or computer code disclosed herein.

[0106] The systems, devices, and / or methods described herein may be implemented by software (implemented on hardware), hardware, or a combination thereof. Hardware modules may include, for example, general-purpose processors (or microprocessors or microcontrollers), field-programmable gate arrays (FPGAs), and / or application-specific integrated circuits (ASICs). Software modules (executed on hardware) may be expressed in a variety of software languages, including C, C++, Java (registered trademark), Ruby, Visual Basic (registered trademark), and / or other object-oriented, procedural, or other programming languages ​​and development tools. Examples of computer code include, but are not limited to, microcode or microinstructions, machine instructions such as those generated by a compiler, code used to generate web services, and files containing higher-level instructions executed by a computer using interpreter programs. Further examples of computer code include, but are not limited to, control signals, encryption code, and compression code.

[0107] The specific examples and descriptions herein are, in practice, typical examples, and embodiments may be developed by those skilled in the art based on the materials taught herein without departing from the scope of the invention, which is limited only by the appended claims.

[0108] [Note 1] An apparatus comprising a memory and a processor operably coupled to the memory, wherein the processor is configured to activate a field generator to generate an electric or magnetic field so that a signal can be received by a receiver coupled to an ablation device positioned adjacent to the tissue surface, to acquire processing data related to the signal, to determine the position and orientation of the ablation device based on the processing data, to determine the planned ablation area of ​​the ablation device within the tissue surface based on the position and orientation of the ablation device, and to display a map of the tissue surface and a visual representation of the planned ablation area in the map of the tissue surface by an output device.

[0109] [Note 2] The apparatus according to Note 1, wherein the planned ablation area is a first planned ablation area, and the processor is further configured to determine a second planned ablation area of ​​the ablation device on the tissue surface in response to a change in the position or orientation of the ablation device, and to display a visual representation of the ablated area on the map of the tissue surface and a visual representation of the second planned ablation area on the map of the tissue surface by the output device.

[0110] [Appendix 3] The apparatus according to Appendix 2, wherein the processor is configured to display a visual representation of the ablated areas and a visual representation of the second planned ablated areas by projecting the ablated areas onto the map of the tissue surface using a first set of marks and projecting the second planned ablated areas onto a graphic representation of the surface using a second set of marks different from the first set of marks.

[0111] [Note 4] The apparatus according to Note 1, wherein the ablation apparatus includes a set of splines, and each spline in the set of splines includes a set of proximal electrodes and a set of distal electrodes, so that the set of splines as a whole includes a plurality of proximal electrodes and a plurality of distal electrodes, and the processor is configured to determine the position and orientation of the ablation apparatus by determining a set of geometric parameters of the ablation apparatus based on the processing data, determining the form of the ablation apparatus based on the set of geometric parameters, and determining at least one of the position and orientation of the ablation apparatus based on the determined form of the ablation apparatus and the processing data.

[0112] [Appendix 5] The apparatus according to Appendix 4, wherein the processor is configured to determine the orientation of the ablation device by determining at least a longitudinal unit vector related to the ablation device.

[0113] [Appendix 6] The apparatus according to Appendix 4, wherein the processor is configured to determine the orientation of the ablation apparatus by identifying at least one deployment configuration having a set of relevant geometric parameters that most closely matches the determined set of relevant geometric parameters from a set of deployment configurations, each having a set of relevant geometric parameters.

[0114] [Appendix 7] The apparatus according to Appendix 6, wherein the processor is configured to identify an expansion having a set of relevant geometric parameters that most closely fits a determined set of geometric parameters by using the least squares method.

[0115] [Appendix 8] The apparatus according to Appendix 1, further comprising an amplifier configured to amplify the signal received by the receiver, wherein the processor is configured to acquire the processed data by digitizing and processing the signal amplified by the amplifier.

[0116] [Note 9] The apparatus according to Note 1, wherein the processor is further configured to cause the output device to display a visual representation of the ablation device based on the position and orientation of the ablation device.

[0117] [Note 10] The apparatus according to Note 1, wherein the ablation apparatus includes a plurality of electrodes, and the processor is configured to determine the planned ablation area of ​​the ablation apparatus by: identifying an electrode that contacts the tissue surface from the plurality of electrodes; identifying a planned ablation area shape from a plurality of planned ablation area shapes based on the position and orientation of the ablation apparatus; and generating the planned ablation area based on the planned ablation area shape, having a center at a location corresponding to the location of the electrode and indicating the location of the tissue surface having the maximum ablation depth.

[0118] [Appendix 11] The apparatus according to Appendix 1, wherein the processor is further configured to construct the map of the tissue surface based on processing data related to the signals received by the receiver when the ablation device is advanced to multiple locations along the tissue surface.

[0119] [Note 12] The apparatus according to Note 1, wherein the map of the tissue surface is represented by a plurality of points forming a point cloud, and the processor is configured to determine the planned ablation area by determining the shortest distance from the ablation device to the tissue surface, identifying from the plurality of points a set of points located within a predetermined distance from the distal end of the ablation device in cases where the shortest distance is less than a predetermined value, determining the center of the set of points, determining a local tangent plane to the surface extending through the center, and determining the center of the planned ablation area indicating the location of the tissue surface having the maximum ablation depth based on the position and orientation of the ablation device with respect to the local tangent plane.

[0120] [Note 13] The apparatus as described in Note 12, wherein the default value is less than approximately 4 mm and the default distance is less than approximately 3 cm. [Note 14] A method comprising: receiving data indicating a signal received by a receiver connected to an ablation device positioned adjacent to a tissue surface, the receiver receiving a signal in response to an electric or magnetic field generated by a field generator, in one of a set of processors; determining the position and orientation of the ablation device based on the data indicating the signal in one of the set of processors; determining a planned ablation area of ​​the ablation device on the tissue surface based on the position and orientation of the ablation device in one of the set of processors; and displaying a map of the tissue surface and a visual representation of the planned ablation area on the map of the tissue surface by an output device operably connected to one of the set of processors.

[0121] [Note 15] The method according to Note 14, further comprising activating a signal generator to generate a pulse waveform to be transmitted to the ablation device, such that the ablation device generates an ablation area corresponding to the planned ablation area.

[0122] [Note 16] The method of Note 15, further comprising displaying a visual representation of the ablation area in the map of the tissue surface, which is different from the visual representation of the planned ablation area, by the output device and based on the transmission of the pulse waveform.

[0123] [Note 17] The method according to Note 16, wherein the ablation device is located in a first location, the location is a first location, the orientation is a first orientation, and the ablation area is a first ablation area, and the method further includes receiving data indicating a signal received by the receiver in accordance with the electric or magnetic field when the ablation device is located in a second location different from the first location, determining a second location and a second orientation of the ablation device based on the data indicating the signal when the ablation device is located in the second location, determining a second planned ablation area of ​​the ablation device on the tissue surface based on the second location and the second orientation of the ablation device, and displaying a visual representation of the first ablation area using a first set of marks and a visual representation of the second planned ablation area using a second set of marks different from the first set of marks using the output device.

[0124] [Note 18] The method according to Note 17, further comprising activating the signal generator to generate the pulse waveform transmitted to the ablation device such that the ablation device generates a second ablated area corresponding to the second planned ablated area, in accordance with the second planned ablated area having a slight overlap greater than a threshold with the first ablated area, wherein the first ablated area and the second ablated area form part of a continuous damage on the tissue surface.

[0125] [Note 19] The threshold is a default value, as described in Note 18. [Note 20] The method according to Note 14, further comprising: receiving data indicating a signal received by the receiver in response to the electric or magnetic field generated by the field generator at each of a plurality of locations where the ablation apparatus including a plurality of electrodes is performed; at each of the plurality of locations, identifying at least one electrode in contact with the tissue surface from the plurality of electrodes based on at least one of (i) the data indicating the signal received by the receiver at that location, and (ii) electrocardiogram (ECG) data recorded from the electrodes; generating a point cloud including a plurality of points, where each point corresponds to the location of an electrode identified at another of the plurality of locations; and constructing the map of the tissue surface using the point cloud.

[0126] [Note 21] The method according to Note 14, wherein the ablation apparatus includes a set of splines, and each spline in the set of splines includes a set of proximal electrodes and a set of distal electrodes, so that the set of splines includes a plurality of proximal electrodes and a plurality of distal electrodes as a whole, and determining the position and orientation of the ablation apparatus includes determining a set of geometric parameters of the ablation apparatus based on received data indicating the signal, determining the form of the ablation apparatus based on the set of geometric parameters, and determining at least one of the position and orientation of the ablation apparatus based on the determined form of the ablation apparatus and the received data indicating the signal.

[0127] [Note 22] The method according to Note 14, further comprising displaying a visual representation of the ablation device on the map of the tissue surface based on the position and orientation of the ablation device using the output device.

[0128] [Note 23] A system comprising: a field generator configured to generate an electric or magnetic field; a signal generator configured to generate a pulse waveform for ablation of tissue; an output device; and a processor operably connected to the field generator, the signal generator, and the output device, wherein the processor is configured to activate the field generator to generate the electric or magnetic field, to acquire processing data related to the signal, to determine the position and orientation of the ablation device based on the processing data, to determine the planned ablation area of ​​the ablation device on the tissue surface based on the position and orientation of the ablation device, to cause the output device to display a map of the tissue surface and a visual representation of the planned ablation area on the map of the tissue surface, and to activate the signal generator to generate the pulse waveform for transmission to the ablation device, to cause the ablation device to generate an ablated area corresponding to the planned ablation area, depending on the planned ablation area corresponding to a desired ablation area.

[0129] [Note 24] The field generator is the system described in Note 23, comprising a set of electrode patches that generate one or more electric fields. [Note 25] The field generator is the system described in Note 23, which includes a set of transmitter coils, each of which generates a time-varying magnetic field.

[0130] [Note 26] The system according to Note 23, wherein the processor is further configured to cause the output device to change the visual display of the planned ablation area to indicate that the planned ablation area has been ablated, in response to activating the signal generator.

[0131] [Note 27] The system according to Note 23, wherein the ablation apparatus includes a set of splines, and each spline in the set of splines includes a set of proximal electrodes and a set of distal electrodes, so that the set of splines includes a plurality of proximal electrodes and a plurality of distal electrodes as a whole, and the processor is configured to determine the position and orientation of the ablation apparatus by determining a set of geometric parameters of the ablation apparatus based on the processing data, determining the form of the ablation apparatus based on the set of geometric parameters, and determining at least one of the position and orientation of the ablation apparatus based on the determined form of the ablation apparatus and the processing data.

[0132] [Note 28] The system according to Note 23, wherein the map of the tissue surface is represented by a plurality of points forming a point cloud, and the processor is configured to determine the planned ablation area by: determining the shortest distance from the ablation device to the tissue surface; identifying from the plurality of points a set of local points located within a predetermined distance from the distal end of the ablation device if the shortest distance is less than a predetermined value; determining a local tangent plane to the surface based on the set of local points; and determining the center of the planned ablation area based on the position and orientation of the ablation device with respect to the local tangent plane.

[0133] [Note 29] An apparatus comprising a memory and a processor operably coupled to the memory, wherein the processor is configured to activate a field generator to generate an electric or magnetic field so that a signal can be received by a receiver coupled to an ablation device positioned adjacent to the tissue surface, acquire processing data related to the signal, determine the position and orientation of the ablation device based on the processing data, display a map of the tissue surface constructed from a plurality of points forming a point cloud using an output device, determine the shortest distance from the ablation device to the tissue surface, identify a set of points within a predetermined distance from the distal end of the ablation device from the plurality of points if the shortest distance is less than a predetermined value, determine the center of the set of points, determine a local tangent plane to the surface extending through the center, determine the center of a planned ablation area indicating the location of the center of the surface of the ablation area based on the position and orientation of the ablation device with respect to the local tangent plane, and display a visual representation of the planned ablation area in the map of the tissue surface using the output device.

[0134] [Note 30] The apparatus according to Note 29, wherein the planned ablation area is a first planned ablation area, the processor is further configured to determine a second planned ablation area of ​​the ablation device on the tissue surface in response to changes in the position and orientation of the ablation device, and the output device displays a visual representation of the ablated area related to the first planned ablation area and a visual representation of the second planned ablation area on the map of the tissue surface.

[0135] [Appendix 31] The apparatus according to Appendix 30, wherein the processor is configured to display a visual representation of the ablated area and a visual representation of the second planned ablated area by projecting the ablation area onto the map of the tissue surface using a first set of marks and projecting the second planned ablation area onto the map of the tissue surface using a second set of marks different from the first set of marks.

[0136] [Note 32] The apparatus according to Note 29, wherein the ablation apparatus includes a set of splines, and each spline in the set of splines includes a set of proximal electrodes and a set of distal electrodes, so that the set of splines includes a plurality of proximal electrodes and a plurality of distal electrodes as a whole, and the processor is configured to determine the position and orientation of the ablation apparatus by determining a set of geometric parameters of the ablation apparatus based on the processing data, determining the form of the ablation apparatus based on the set of geometric parameters, and determining at least one of the position and orientation of the ablation apparatus based on the determined form of the ablation apparatus and the processing data.

[0137] [Appendix 33] The apparatus according to Appendix 32, wherein the processor is configured to determine the orientation of the ablation device by determining at least a longitudinal unit vector related to the ablation device.

[0138] [Appendix 34] The apparatus according to Appendix 32, wherein the processor is configured to determine the orientation of the ablation apparatus by (1) having a set of relevant geometric parameters that most closely conform to a determined set of geometric parameters, and (2) identifying at least one of a set of deployments which each has a set of relevant geometric parameters.

[0139] [Appendix 35] The apparatus according to Appendix 34, wherein the processor is configured to identify an expansion having a set of relevant geometric parameters that most closely fits a determined set of geometric parameters by using the least squares method.

[0140] [Appendix 36] The apparatus according to Appendix 29, further comprising an amplifier configured to amplify the signal received by the receiver, wherein the processor is configured to acquire the processed data by digitizing and processing the signal amplified by the amplifier.

[0141] [Appendix 37] The apparatus according to Appendix 29, wherein the processor is further configured to display a visual representation of the ablation device by the output device based on the position and orientation of the ablation device.

[0142] [Note 38] The apparatus according to Note 29, wherein the ablation apparatus includes a plurality of electrodes, and the processor is further configured to identify an electrode from the plurality of electrodes that contacts the tissue surface and whose center in the planned ablation area is located at a location corresponding to the location of that electrode, and to identify the planned ablation area shape having of a plurality of planned ablation area shapes from the planned ablation area shapes.

[0143] [Appendix 39] The apparatus according to Appendix 29, wherein, when the ablation device is advanced to multiple locations within the heart, the processor is further configured to construct the map of the tissue surface based on processing data related to the signals received by the receiver.

[0144] [Note 40] The apparatus as described in Note 29, wherein the default value is less than approximately 4 mm and the default distance is less than approximately 3 cm. [Note 41] A receiver connected to an ablation device positioned adjacent to the tissue surface, which receives a signal in response to an electric field or magnetic field generated by a field generator, receives data indicating the signal received by the receiver, and determines the position and orientation of the ablation device based on the data indicating the signal, and displays a map of the tissue surface constructed from a plurality of points forming a point cloud by an output device operably connected to one of the processors, and determines the shortest distance from the ablation device to the tissue surface by one of the processors A method comprising: determining the shortest distance, identifying a set of local points located within a predetermined distance from the distal end of the ablation device using one of the set of processors, depending on whether the shortest distance is smaller than a predetermined value; determining a local tangent plane to the surface using one of the set of processors based on the set of local points; determining the center of the planned ablation area using one of the set of processors based on the position and orientation of the ablation device with respect to the local tangent plane; and displaying a visual representation of the planned ablation area in the map of the tissue surface using the output device.

[0145] [Appendix 42] The method according to Appendix 41, further comprising activating a signal generator to generate a pulse waveform to be transmitted to the ablation device, such that the ablation device generates an ablated area corresponding to the planned ablation area.

[0146] [Note 43] The method of Note 42, further comprising displaying a visual representation of the ablated areas in the map of the tissue surface, which is different from the visual representation of the planned ablation areas, based on the transmission of the pulse waveform by the output device.

[0147] [Note 44] The method according to Note 43, wherein the data indicating the signal received by the receiver is received when the ablation device is in a first location, the position of the ablation device is the first position of the ablation device, the orientation of the ablation device is the first orientation of the ablation device, the planned ablation area is the first planned ablation area, and the method further includes receiving data indicating the signal received by the receiver in accordance with the electric or magnetic field when the ablation device is in a second location different from the first location, determining the second location and second orientation of the ablation device based on the data indicating the signal when the ablation device is in the second location, determining a second planned ablation area of ​​the ablation device on the tissue surface based on the second location and second orientation of the ablation device, and displaying a visual representation of the ablated area using a first set of marks and a visual representation of the second planned ablation area using a second set of marks different from the first set of marks by the output device.

[0148] [Note 45] The method according to Note 44, wherein the ablated area is a first ablated area, and the method comprises activating the signal generator to generate the pulse waveform transmitted to the ablated device such that the ablated device generates a second ablated area corresponding to the second planned ablated area, depending on the second planned ablated area having a slight overlap greater than a threshold with the first ablated area, the first ablated area and the second ablated area form part of a continuous damage in the tissue surface.

[0149] [Note 46] The threshold is a default value, as described in Note 45. [Note 47] The method according to Note 41, wherein the signal is a first signal, and the method includes receiving data indicating a second signal received by the receiver in response to the electric or magnetic field generated by the field generator at each of a plurality of locations where the ablation apparatus including a plurality of electrodes is advanced; at each of the plurality of locations, identifying at least one electrode in contact with the tissue surface from the plurality of electrodes based on at least one of (i) the data indicating the second signal received by the receiver at that location, or (ii) electrocardiogram (ECG) data recorded from the electrodes; generating the point cloud including the plurality of points, each of which corresponds to the location of at least one electrode identified at each of the plurality of locations; and constructing the map of the tissue surface using the point cloud.

[0150] [Note 48] The method according to Note 41, wherein the ablation apparatus includes a set of splines, and each spline in the set of splines includes a set of proximal electrodes and a set of distal electrodes, so that the set of splines includes a plurality of proximal electrodes and a plurality of distal electrodes as a whole, and determining the position and orientation of the ablation apparatus includes determining a set of geometric parameters of the ablation apparatus based on received data indicating the signal, determining the form of the ablation apparatus based on the set of geometric parameters, and determining at least one of the position or orientation of the ablation apparatus based on the determined form of the ablation apparatus and the received data indicating the signal.

[0151] [Appendix 49] The method according to Appendix 41, further comprising displaying a visual representation of the ablation device on the map of the tissue surface based on the position and orientation of the ablation device using the output device.

[0152] [Note 50] The system includes a field generator configured to generate an electric or magnetic field, a signal generator configured to generate a pulse waveform for ablation of tissue, an output device, and a processor operably connected to the field generator, the signal generator, and the output device, wherein the processor activates the field generator to generate the electric or magnetic field, generates a signal, acquires processing data related to the signal, determines the position and orientation of the ablation device based on the processing data, displays a map of the tissue surface constructed from a plurality of points forming a point cloud on the output device, determines the shortest distance from the ablation device to the tissue surface, and the shortest distance A system configured to identify a set of local points located within a predetermined distance from the distal end of the ablation device in accordance with a distance smaller than a predetermined value, to determine a local tangent plane to the surface based on the set of local points, to determine the center of a planned ablation area based on the position and orientation of the ablation device with respect to the local tangent plane, to display a visual representation of the planned ablation area on the map of the tissue surface on the output device, and to activate the signal generator to generate the pulse waveform transmitted to the ablation device so that the ablation device generates an ablated area corresponding to the planned ablation area, depending on the planned ablation area corresponding to a desired ablation area.

[0153] [Appendix 51] The system according to Appendix 50, wherein the field generator includes a set of electrode patches that generate one or more electric fields, and the electric field or magnetic field includes the one or more electric fields generated by the set of electrode patches.

[0154] [Note 52] The system according to Note 50, wherein the field generator includes a set of transmitter coils, each of which generates a time-varying magnetic field, and the electric or magnetic field includes the time-varying magnetic field generated by the set of transmitter coils.

[0155] [Note 53] The system according to Note 50, wherein the processor is further configured to cause the output device to provide a visual indication of the planned ablation area to indicate that the planned ablation area has been ablated, in response to activating the signal generator.

[0156] [Note 54] The system according to Note 50, wherein the ablation apparatus includes a set of splines, and each spline in the set of splines includes a set of proximal electrodes and a set of distal electrodes, so that the set of splines includes a plurality of proximal electrodes and a plurality of distal electrodes as a whole, and the processor is configured to determine the position and orientation of the ablation apparatus by determining a set of geometric parameters of the ablation apparatus based on the processing data, determining the form of the ablation apparatus based on the set of geometric parameters, and determining at least one of the position and orientation of the ablation apparatus based on the determined form of the ablation apparatus and the processing data.

[0157] [Appendix 55] The ablation apparatus is the apparatus described in any one of Appendices 1 to 53, comprising a plurality of splines configured to form a basket shape. [Note 56] The ablation device is the apparatus described in any one of Notes 1 to 53, including a distal portion that has a linear shape.

Claims

1. A field generator configured to generate an electric field or a magnetic field, A signal generator configured to generate pulse waveforms for tissue ablation, Output device and The field generator, the signal generator, and the output device include a processor operably connected to them. The aforementioned processor, The field generator is activated to generate an electric or magnetic field so that a signal is received by a receiver connected to an ablation device positioned adjacent to the tissue surface. The signal received by the receiver is processed to obtain processed data representing the signal. Based on the processing data, the position and orientation of the ablation device are determined. Determining the shortest distance from the ablation device to the tissue surface, Depending on whether the shortest distance is smaller than a predetermined value, the distal end of the ablation device identifies a set of local points that are within a predetermined distance from a plurality of points that form a point cloud representing a map of the tissue surface. Based on the aforementioned set of local points, a local tangent plane to the tissue surface is determined, Based on the position and orientation of the ablation device with respect to the local tangent plane, the center of the planned ablation area is determined. Based on this, the planned ablation area for the ablation device is determined on the tissue surface. The output device is made to display the map of the tissue surface represented by the plurality of points forming the point cloud, and a visual display of the planned ablation area in the map of the tissue surface. A system configured to activate the signal generator to generate the pulse waveform to be delivered to the ablation device, such that the ablation device generates an ablated area corresponding to the planned ablation area, depending on the planned ablation area corresponding to the desired ablation area.

2. The system according to claim 1, wherein the field generator includes a set of electrode patches that generate one or more electric fields.

3. The system according to claim 1, wherein the field generator includes a set of transmitter coils, each transmitter coil generating a time-varying magnetic field.

4. The system according to claim 1, wherein the processor is configured to change the visual display of the planned ablation area on the output device to indicate that the planned ablation area has been ablated, in response to activating the signal generator.

5. The ablation apparatus includes a set of splines, and each spline in the set of splines includes a set of proximal electrodes and a set of distal electrodes; therefore, the set of splines as a whole includes multiple proximal electrodes and multiple distal electrodes. The aforementioned processor, Based on the processing data, determine the set of geometric parameters of the ablation device, The form of the ablation device is determined based on the set of geometric parameters, By determining at least one of the position and orientation of the ablation device based on the determined form of the ablation device and the processing data, The system according to claim 1, configured to determine at least one of the position and orientation of the ablation device.

6. The system according to claim 1, wherein the field generator is a magnetic field generator configured to generate a magnetic field, and the receiver is a sensor configured to receive a signal corresponding to the magnetic field.

7. The ablation device is a linear local ablation catheter including a set of proximal electrodes and a set of distal electrodes, wherein the set of proximal electrodes and the set of distal electrodes are configured to receive the pulse waveform generated by the signal generator, according to claim 1 or 6.

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