Electric field visualization for electroporation catheters with multiple states

Abstract

A system for electroporation ablation including an electrode assembly and a catheter having one or more states. The electrode assembly may be of different shapes when the catheter is in the different states. The controller is configured to generate a graphical representation of an electric field generated by the electrode assembly when the catheter is in the different states based on one or more models of the electric field. In some embodiments, the controller is configured to overlay the graphical representation of the one or more electric fields on an anatomical map of the patient.

Description

Technical Field

[0001] The present disclosure relates to medical systems and methods for ablating a patient's tissue. More specifically, the present disclosure relates to medical systems and methods for ablation of tissue by electroporation.

Background Art

[0002] Ablation procedures are used to treat many different conditions in patients. Ablation can be used to treat cardiac arrhythmias, benign tumors, cancerous tumors, and to control bleeding during surgery. Typically, ablation is achieved by thermal ablation techniques including radiofrequency (RF) ablation and cryoablation. In RF ablation, a probe is inserted into the patient and high-frequency waves are transmitted through the probe to the surrounding tissue. The high-frequency waves generate heat, which destroys the surrounding tissue and cauterizes blood vessels. In cryoablation, a hollow needle or cryoprobe is inserted into the patient and a cryogenic heat-conductive fluid is circulated through the probe to freeze and kill the surrounding tissue. RF ablation and cryoablation techniques kill tissue indiscriminately through cell necrosis, which can damage or kill otherwise healthy tissue such as tissue in the esophagus, intercostal nerve cells, and tissue in the coronary artery.

[0003] [[ID=1�]]Another ablation technique uses electroporation. In electroporation or electropermeabilization, an electric field is applied to cells to increase the permeability of the cell membrane. Electroporation can be reversible or irreversible depending on the intensity of the electric field. When electroporation is reversible, the increased permeability of the cell membrane can be used to introduce chemicals, drugs, and / or deoxyribonucleic acid (DNA) into the cells before the cells heal and recover. When electroporation is irreversible, the affected cells die by apoptosis.

[0004] Irreversible electroporation can be used as a non-thermal ablation technique. In irreversible electroporation, a series of short, high-voltage pulses are used to generate an electric field strong enough to kill cells by apoptosis. In cardiac tissue ablation, irreversible electroporation may be a safe and effective alternative to the indiscriminate killing achieved by thermal ablation techniques such as RF ablation and cryoablation. Irreversible electroporation can be used to kill target tissues such as cardiomyocytes by using an electric field intensity and duration that kills the target tissue but does not permanently damage other cells or tissues such as non-target cardiomyocytes, red blood cells, vascular smooth muscle tissue, endothelial tissue, and nerve cells. Planning irreversible electroporation ablation procedures can be challenging due to the lack of acute visualization and data indicating which tissues have been irreversibly electroporated, in contrast to reversibly electroporated tissue. Tissue recovery can occur over minutes, hours, or days after the ablation is complete. [Overview of the Initiative]

[0005] In Example 1, the system for electroporation ablation comprises an electrode assembly and a catheter having multiple states, wherein the electrode assembly has a first shape when the catheter is in a first state among the multiple states, and the electrode assembly has a second shape when the catheter is in a second state among the multiple states. The second shape may be different from the first shape, and the electrode assembly may include multiple electrodes. The system for electroporation ablation further comprises a controller configured to generate a first graphical representation of a first electric field generated by multiple electrodes when the catheter is in a first state and deployed in close proximity to a target site, based on a first model of the electric field. The controller further generates a second graphical representation of a second electric field generated by multiple electrodes when the catheter is in a second state and deployed in close proximity to a target site, based on a second model of the electric field, and the graphical user interface may be configured to overlay the first graphical representation of the first electric field and the second graphical representation of the second electric field onto an anatomical map of the patient in close proximity to the target site.

[0006] In Example 2, the second shape is not similar to the first shape in the system of Example 1. In Example 3, in the system of Example 1, the second shape has a smaller volume than the first shape. In Example 4, in any of the systems in Examples 1-3, the catheter includes a catheter shaft defining a longitudinal axis, and the electrode assembly includes a plurality of splines, a proximal end, and a distal end, at least some of the plurality of electrodes are positioned on the plurality of splines, and the proximal end of the electrode assembly extends from the catheter shaft.

[0007] In Example 5, in the system of Example 4, each spline of the multiple splines is arranged curvilinearly around the longitudinal axis between the distal and proximal ends of the electrode assembly when the catheter is in the first state.

[0008] In Example 6, in the system of Example 4, multiple splines are arranged in a petal-like curve when the catheter is in the second state. In Example 7, in any of the systems in Examples 1-6, the controller is further configured to generate a display of the difference between a first graphical representation of the first electric field and a second graphical representation of the second electric field.

[0009] In Example 8, in any of the systems in Examples 1 to 7, the first graphical representation of the first electric field includes one or more first areas, and the electric field intensity of the first electric field within one or more first areas is greater than a predetermined threshold.

[0010] In Example 9, in the system of Example 8, the second graphical representation of the second electric field includes one or more second areas, and the magnitude of the electric field intensity of the second electric field within one or more second areas is greater than a predetermined threshold.

[0011] In Example 10, in any of the systems in Examples 1-9, the first graphical representation includes the first representation of the catheter. In Example 11, in any of the systems from Examples 1 to 10, the controller is further configured to generate a software widget that includes a second display of the catheter and a display of one or more treatment sessions of electroporation ablation performed by the catheter, and to present the software widget in a graphical user interface. In some examples, the software widget includes a display that identifies a particular treatment session from one or more treatment sessions.

[0012] In Example 12, a method for planning electroporation ablation includes the steps of: generating a first graphical representation of a first electric field using electrodes on a catheter in a first state, based on a first model of the electric field using a controller, wherein the catheter includes an electrode assembly having a first shape when the catheter is in the first state; presenting the first graphical representation of the electric field and an anatomical map of the patient adjacent to the target site on a display; generating a second graphical representation of a second electric field using electrodes on a catheter in a second state, based on a second model of the electric field, wherein the catheter includes an electrode assembly having a second shape when the catheter is in a second state, the second shape being different from the first shape; and presenting the second graphical representation of the electric field and an anatomical map of the patient adjacent to the target site on a display.

[0013] In Example 13, the second shape is not similar to the first shape in the method of Example 12. Example 14 further includes the step of generating a display of the difference between a first graphical representation of a first electric field and a second graphical representation of a second electric field, in the manner of either Example 12 or 13.

[0014] Example 15 further includes the steps of generating a software widget that includes a second representation of the catheter and a display of one or more treatment sessions of electroporation ablation performed by the catheter, in any of the methods of Examples 12 to 14, and presenting the software widget on a display.

[0015] In Example 16, the system for electroporation ablation comprises a catheter having multiple electrodes and a controller configured to generate a software widget that includes a representation of the catheter and a display of one or more treatment sessions of electroporation ablation performed by the catheter, and to present the software widget on a graphical user interface. In some examples, the software widget includes a display that identifies a particular treatment session out of one or more treatment sessions.

[0016] In Example 17, the controller is further configured in the system of Example 16 to generate and display graphical representations of the electric fields of multiple electrodes based on an electric field model.

[0017] In Example 18, in either the system of Example 16 or 17, the software widget includes a cross-sectional view of the catheter. In Example 19, in any of the systems in Examples 16–18, the software widget includes an alignment indicator that represents the axial relationship between the catheter axis of the catheter and the target axis of the target ablation area of ​​the electroporation ablation.

[0018] In Example 20, in any of the systems in Examples 16-19, the representation of the catheter includes a first representation of the catheter at a first time and a second representation of the catheter at a second time.

[0019] In Example 21, in the system of Example 20, the first and second representations indicate the difference between the catheter at a first time and the catheter at a second time, the difference including at least one of the following: a difference in shape, a difference in rotation angle, a difference in electric field intensity, and a difference in location.

[0020] In Example 22, in any of the systems in Examples 16-21, the software widget further includes an electric field display representing the electric field generated by multiple electrodes. Although multiple embodiments are disclosed, further embodiments of the present invention will be apparent to those skilled in the art from the following detailed description which illustrates and describes exemplary embodiments of the present invention. Accordingly, the drawings and detailed description are to be regarded as illustrative in nature and not restrictive.

Brief Description of the Drawings

[0021] [Figure 1] FIG. is a diagram showing an exemplary clinical facility for treating a patient using an electrophysiology system and for treating a patient's heart according to an embodiment of the subject matter of the present disclosure. [Figure 2A] FIG. is a schematic diagram showing a catheter that can be used for electroporation including ablation by irreversible electroporation according to an embodiment of the subject matter of the present disclosure. [Figure 2B] FIG. is a schematic diagram showing a catheter that can be used for electroporation including ablation by irreversible electroporation according to an embodiment of the subject matter of the present disclosure. [Figure 3A] FIG. is a schematic diagram showing a catheter that can be used for electroporation including ablation by irreversible electroporation according to an embodiment of the subject matter of the present disclosure. [Figure 3B] FIG. is a schematic diagram showing a catheter that can be used for electroporation including ablation by irreversible electroporation according to an embodiment of the subject matter of the present disclosure. [Figure 3C] FIG. is a schematic diagram showing a catheter that can be used for electroporation including ablation by irreversible electroporation according to an embodiment of the subject matter of the present disclosure. [Figure 4A] FIG. is a diagram showing an example of a graphical user interface according to an embodiment of the subject matter of the present disclosure. [Figure 4B] FIG. is a diagram showing an example of a graphical user interface according to an embodiment of the subject matter of the present disclosure. [Figure 5A] FIG. shows a software widget that facilitates the planning and / or implementation of ablation therapy according to an embodiment of the subject matter of the present disclosure. [Figure 5B]Shows a software widget that facilitates the planning and / or implementation of ablation therapy according to embodiments of the subject matter of the present disclosure. [Figure 5C] Shows a software widget that facilitates the planning and / or implementation of ablation therapy according to embodiments of the subject matter of the present disclosure. [Figure 6A] Is a diagram showing a graphical representation of a software widget and an electric field displayed side by side according to embodiments of the subject matter of the present disclosure. [Figure 6B] Is a diagram showing a graphical representation of a software widget and an electric field displayed side by side according to embodiments of the subject matter of the present disclosure. [Figure 7A] Shows examples of electric fields with various intensities generated by a catheter including an electrode assembly. [Figure 7B] Shows examples of electric fields with various intensities generated by a catheter including an electrode assembly. [Figure 8] Is a flowchart diagram showing a method for planning ablation by irreversible electroporation according to embodiments of the subject matter of the present disclosure.

[0022] Although the present invention can accept various modifications and alternative forms, specific embodiments are shown by way of example in the drawings and are described in detail below. However, the intention is not to limit the present invention to the specific embodiments described. Rather, the present invention is intended to embrace all modifications, equivalents, and alternative forms that fall within the scope of the present invention as defined by the appended claims.

Mode for Carrying Out the Invention

[0023] The following detailed description is illustrative in nature and is not intended in any way to limit the scope, applicability, or configuration of the invention. Rather, the following description provides several practical examples for implementing exemplary embodiments of the invention. Examples of configurations, materials, and / or dimensions are provided for selected elements. Those skilled in the art will recognize that many of the examples mentioned have various suitable alternative forms.

[0024] As used herein with respect to measurements (e.g., dimensions, characteristics, attributes, components, etc.) of tangible things (e.g., products, inventory, etc.) and / or intangible things (e.g., data, electronic representations of currency, accounts, information, parts of things (e.g., percentages, fractions), calculations, data models, dynamic system models, algorithms, parameters, etc.) and their range, “about” and “approximately” include the mentioned measurement and are reasonably close to the mentioned measurement, but exclude measurement errors, differences in measurement and / or manufacturing equipment calibration, human errors in reading and / or setting of measurement values, other measurement values ​​(e.g.) For example, the term can be used interchangeably to refer to any measurement that may differ by a moderately small amount, as can be easily understood and confirmed by those skilled in the art, due to adjustments made to optimize performance and / or structural parameters (taking into account measurements related to other things), specific implementation scenarios, improper adjustments and / or manipulation of things, settings, and / or measurements by people, computer devices, and / or machines, system tolerances, control loops, machine learning, predictable variations (e.g., statistically insignificant variations, chaotic variations, system and / or model instability, etc.), preferences, etc.

[0025] Exemplary methods may be represented by one or more drawings (e.g., flow charts, communication flows, etc.), but the drawings should not be construed as suggesting any requirements for any of the various steps disclosed herein, or any particular order between them. However, certain embodiments may require certain steps and / or a particular order between certain steps, as can be explicitly described herein and / or inferred from the nature of the steps themselves (e.g., the performance of some steps may depend on the results of previous steps). In addition, a “set,” “subset,” or “group” of items (e.g., inputs, algorithms, data values, etc.) may include one or more items, and similarly, a subset or subgroup of items may include one or more items. “Multiple” means more than one.

[0026] As used herein, the term “based on” is not limited to any particular set of terms, but rather indicates that a decision, identification, prediction, calculation, etc., is performed by using at least the term following “based on” as input. For example, predicting an outcome based on certain information may, additionally or alternatively, be based on other information for the same decision.

[0027] Irreversible electroporation (IRE) uses short (e.g., less than 100 microseconds) high-voltage pulses to kill cells by apoptosis. IRE can be targeted to kill cardiomyocytes without damaging other adjacent tissues, including esophageal vascular smooth muscle and endothelium. IRE treatment may be delivered in multiple treatment sections. Each treatment section (e.g., with a duration of 10 milliseconds) may contain multiple electrical pulses (e.g., 20 pulses, 30 pulses, etc.) generated and delivered by an electroporation device powered by an electroporation generator.

[0028] Figure 1 shows an exemplary clinical setup 10 for treating a patient 20 and the patient 20's heart 30 using an electrophysiology system 50, according to embodiments of the subject matter of this disclosure. The electrophysiology system 50 includes an electroporation device 60, a display 92, and an optional location-specific field generator 80. The clinical setup 10 also includes additional equipment such as an imaging device 94 (represented by a C-arm) and various controller elements configured to allow an operator to control various aspects of the electrophysiology system 50. As will be understood by those skilled in the art, the clinical setup 10 may have other components and configurations not shown in Figure 1.

[0029] The electroporation device 60 includes an electroporation catheter 105, an introduction sheath 110, a controller 90, and an electroporation generator 130. In the embodiment, the electroporation device 60 is configured to deliver electric field energy to target tissue in the patient's heart 30 to induce tissue apoptosis, thereby preventing the tissue from conducting electrical signals. Furthermore, as will be described in more detail below, the electroporation device 60 is configured to assist the user in planning irreversible electroporation ablation using the electroporation catheter 105 (e.g., planning ablation before and during the ablation procedure) by generating a graphical representation of the electric field that can be generated using the electroporation catheter 105, based on a model of the electric field, and overlaying the graphical representation of the electric field onto an anatomical map of the patient's heart on the display 92.

[0030] In the embodiment, the electroporation device 60 is configured to generate a graphical representation of the electric field based on the characteristics of the electroporation catheter 105 and the location of the electroporation catheter 105 within the patient 20, such as within the patient 20's heart 30.

[0031] The controller 90 is configured to control the functional aspects of the electroporation device 60. In the embodiment, the controller 90 is configured to control the electroporation generator 130 to generate electrical pulses, such as the magnitude, timing, and duration of the electrical pulses. In the embodiment, the electroporation generator 130 is capable of operating as a pulse generator to generate a pulse sequence and supply it to the electroporation catheter 105.

[0032] In the embodiment, the introducer sheath 110 is operable to provide a delivery conduit through which the electroporation catheter 105 can be deployed to a specific target site in the patient's heart 30. However, it will be understood that the introducer sheath 110 is illustrated and described herein to provide the context of the entire electrophysiology system 50.

[0033] As will be understood by those skilled in the art, the depiction of the electrophysiological system 50 shown in Figure 1 is intended to provide a general overview of the various components of the system 50, and is not intended in any way to suggest that this disclosure is limited to any set of components or arrangement of components. For example, those skilled in the art will readily recognize that additional hardware components, such as breakout boxes, workstations, etc., may and likely be included in the electrophysiological system 50.

[0034] In the illustrated embodiment, the electroperforation catheter 105 includes a handle 105a, a shaft 105b, and an electrode assembly 150. The handle 105a is configured to be operated by the user to position the electrode assembly 150 at a desired anatomical location. The shaft 105b has a distal end 105c and generally defines the longitudinal axis of the electroperforation catheter 105. As shown, the electrode assembly 150 is positioned at or near the distal end 105c of the shaft 105b. In the embodiment, the electrode assembly 150 is electrically coupled to an electroperforation generator 130 to receive an electrical pulse sequence or pulse train, thereby selectively generating an electric field for ablation of target tissue by irreversible electroperforation.

[0035] In some embodiments, as shown in Figure 1, the electrode assembly 150 includes one or more electrodes 152. The electrodes 152 may include an ablation electrode and, optionally, a mapping electrode. In some configurations, the mapping electrode is configured to be used to generate a detailed three-dimensional geometric anatomical map or representation of the cardiac chambers, as well as an electroanatomical map in which the cardiac electrical activity of interest is superimposed on the geometric anatomical map, and to be displayed by the display 92.

[0036] In certain embodiments, the electroporation catheter 105 is a catheter having an electrode assembly and multiple states. In embodiments, the electrode assembly has a first shape when the catheter 105 is in a first state of the multiple states, and a second shape when the catheter 105 is in a second state of the multiple states. The electrode assembly includes multiple electrodes. In some embodiments, the second shape of the electrode assembly is different from the first shape. In some embodiments, the second shape of the electrode assembly is not similar to the first shape. In some embodiments, the volume of the second shape of the electrode assembly is smaller than the volume of the first shape. The catheter 105 may have more than two states. In some embodiments, the catheter 105 has states that are continuous with respect to each other, as opposed to states that are discrete with respect to each other. In other words, the catheter can be tuned along a continuous spectrum of states and is not limited to a discrete finite number of states. In certain examples, the electrode assembly of the catheter 105 may have more than two different shapes.

[0037] In some embodiments, the controller 90 is configured to generate a graphical user interface 95 that is rendered on a display 92. In some embodiments, the controller 90 is configured to collect data associated with the catheter 105 and / or treatment session and store it in a data repository (e.g., a file, a database, etc.). In some examples, the controller 90 is configured to generate a first graphical representation of a first electric field generated by multiple electrodes based on a first model of the electric field, and a second graphical representation of a second electric field generated by multiple electrodes based on a second model of the electric field, and to overlay the first and second graphical representations of the electric field onto an anatomical map of the patient at the catheter location on a graphical user interface rendered on a display 92. The first graphical representation is generated when the catheter is in a first state and deployed in close proximity to the target location. The second graphical representation is generated when the catheter is in a second state and deployed in close proximity to the target location.

[0038] In some examples, the controller 90 is configured to determine the electric field based on the known shapes of the electrode assembly of the catheter 105 in different states (e.g., two or more states, a continuous state) and to generate a graphical representation of the corresponding electric field. In a particular example, the controller 90 is configured to determine the electric field based on the known relative electrode locations of the electrode assembly of the catheter 105 in different states (e.g., two or more states, a continuous state) and to generate a graphical representation of the corresponding electric field.

[0039] In some embodiments, the controller 90 is further configured to generate a display of the difference between a first graphical representation of a first electric field and a second graphical representation of a second electric field. In some examples, the first graphical representation of the first electric field includes one or more first areas, and the magnitude of the electric field intensity of the first electric field in one or more first areas is greater than a predetermined threshold. In some examples, the second graphical representation of the second electric field includes one or more second areas, and the magnitude of the electric field intensity of the second electric field in one or more second areas is greater than a predetermined threshold. In some embodiments, the first graphical representation includes a representation of the catheter 105.

[0040] In some embodiments, as described in more detail below, the controller 90 may be configured to generate a software widget that includes a representation of the catheter 105 and a representation of one or more treatment sessions of electroporation ablation performed by the catheter 105, and to present the software widget in a graphical user interface. In embodiments, the software widget includes a representation that identifies a particular treatment session out of one or more treatment sessions. In embodiments, the software widget includes representations of multiple treatment sessions in which the catheter 105 is in various states having different rotation angles, different locations, and / or different shapes (e.g., basket shape, flower shape, etc.). In one example, for ablation treatment, the catheter is deployed to perform eight treatment sessions, including being positioned at four different rotation angles and in two different shapes at each angle. In some embodiments, the software widget includes a schematic cross-sectional view of the catheter 105. The controller 90 may further be configured to generate a graphical representation of the electric fields of multiple electrodes based on an electric field model and to display the graphical representation of the electric fields of multiple electrodes within the software widget.

[0041] In some examples, the representation of catheter 105 includes a first representation of the catheter at a first time and a second representation of the catheter at a second time. The first and second representations may show the difference between the catheter at the first time and the catheter at the second time. The shown difference includes at least one of the following: a difference in shape, a difference in rotation angle, a difference in electric field intensity, and a difference in location. In some embodiments, a software widget includes an electric field display representing the electric field.

[0042] In some embodiments, the software widget includes an alignment indicator that represents alignment information of the catheter 105. In some examples, the alignment indicator represents the axial relationship between the catheter 105 at a first time and the catheter 105 at a second time, for example, a change in the orientation of the catheter 105 during one treatment session from a previous treatment session. In a particular example, the alignment indicator represents the axial relationship between the catheter and the target ablation area of ​​the electroporation ablation treatment.

[0043] In some embodiments, one or more mapping electrodes on the electroperforation catheter 105 can measure electrical signals and generate output signals that can be processed by a controller 90 to produce an electroanatomical map, also known as an anatomical map. In some examples, the electroanatomical map is generated before ablation to determine the electrical activity of cardiac tissue within the cardiac chamber of interest. In some examples, the electroanatomical map is generated after ablation to verify desired changes in the electrical activity of the ablated tissue and the entire cardiac chamber. The mapping electrodes may also be used to determine the position of the catheter 105 in three-dimensional space within the body. For example, when an operator moves the distal end of the catheter 105 within the cardiac chamber of interest, the boundaries of the catheter movement may be used by the controller 90, which may include or be coupled to a mapping and navigation system to form an anatomical map of the cardiac chamber. An anatomical map of the cardiac chambers may be used to facilitate the navigation of the catheter 105 without the use of ionizing radiation such as fluoroscopy, and to tag the ablation site when the ablation is complete, to guide the ablation interval and help the operator to completely ablate the anatomical structure of interest.

[0044] According to the embodiments, various components of the electrophysiological system 50 (e.g., controller 90) may be implemented on one or more computer devices. The computer devices may include any type of computer device suitable for implementing embodiments of the present disclosure. Examples of computer devices include dedicated or general-purpose computer devices such as workstations, servers, laptops, portable devices, desktops, tablet computers, handheld devices, and general-purpose graphics processing units (GPGPUs), all of which are contemplated within the scope of Figure 1 with respect to the various components of the system 50.

[0045] In some embodiments, a computer device includes buses that directly and / or indirectly connect the following devices: processors, memory, input / output (I / O) ports, I / O components, and power supplies. Any number of additional components, different components, and / or combinations of components may also be included in this computer device. A bus represents what may be one or more buses (e.g., an address bus, a data bus, or a combination thereof). Similarly, in some embodiments, a computer device may include several processors, several memory components, several I / O ports, several I / O components, and / or several power supplies. In addition, any number of these components or combinations thereof may be distributed and / or replicated across several computer devices.

[0046] In some embodiments, the system 50 includes one or more memories (not shown). One or more memories include computer-readable media in the form of volatile and / or non-volatile memory, temporary and / or non-temporary storage media, and may be removable, non-removable, or a combination thereof. Examples of media include random access memory (RAM), read-only memory (ROM), electronically erasable programmable read-only memory (EEPROM), flash memory, optical or holographic media, magnetic cassettes, magnetic tapes, magnetic disk storage devices or other magnetic storage devices, data transmission, and / or any other media that can be used to store information and can be accessed by a computer device, such as quantum state memory. In some embodiments, one or more memories store computer-executable instructions for causing a processor (e.g., controller 90) to implement embodiments of the system components discussed herein and / or perform embodiments of the methods and procedures discussed herein.

[0047] Computer executable instructions may include, for example, computer code, machine-usable instructions, and program components that can be executed by one or more processors associated with a computer device. Program components can be programmed using any number of different programming environments, including various languages, development kits, frameworks, etc. Some or all of the functions contemplated herein may be implemented in hardware and / or firmware, either further or alternatively.

[0048] In some embodiments, the memory may include a data repository that can be implemented using one of the configurations described below. The data repository may include random access memory, flat files, XML files, and / or one or more database management systems (DBMS) running on one or more database servers or data centers. The database management system may be a relational (RDBMS), hierarchical (HDBMS), multidimensional (MDBMS), object-oriented (ODBMS or OODBMS), or object-relational (ORDBMS) database management system, etc. The data repository may be, for example, a single relational database. In some cases, the data repository may include multiple databases that can exchange and aggregate data by a data integration process or software application. In exemplary embodiments, at least a portion of the data repository may be hosted in a cloud data center. In some cases, the data repository may be hosted on a single computer, server, storage device, cloud server, etc. In some other cases, the data repository may be hosted on a set of networked computers, servers, or devices. In some cases, the data repository may be hosted on a tier of data storage devices including local, regional, and central.

[0049] Various components of System 50 may communicate or be connected via communication interfaces, such as wired or wireless interfaces. These communication interfaces include, but are not limited to, any wired or wireless short-range and long-range communication interfaces. Wired interfaces may use cables, umbilicals, etc. Short-range communication interfaces may be, for example, local area networks (LANs), or interfaces conforming to known communication standards such as Bluetooth®, IEEE 802 (e.g., IEEE 802.11), ZigBee® or similar specifications based on IEEE 802.15.4, or other public or proprietary wireless protocols. Long-range communication interfaces may be, for example, wide area networks (WANs), cellular network interfaces, satellite communication interfaces, etc. Communication interfaces may be located within private computer networks such as intranets, or on public computer networks such as the Internet.

[0050] Figures 2A and 2B are schematic diagrams showing an electropermeable ablation catheter 200 that can be used for electropermeable ablation, including irreversible electropermeable ablation, according to embodiments of the subject matter of this disclosure. Figure 2A shows the catheter 200 in a first state, and Figure 2B shows the catheter 200 in a second state. The catheter 200 may have two or more states, which may be formed or controlled by the user, or may be automatically formed by the electropermeable system during treatment. The catheter 200 includes a catheter shaft 202 and a plurality of catheter splines 204 connected to the catheter shaft 202 at its distal end 206. The catheter 200 may further include an internal shaft 203 located within the catheter shaft 202 and extending distally from the distal end 206 of the catheter shaft 202. As understood, the catheter shaft 202 is coupled at its proximal end to a handle assembly (not shown) configured to be operated by the user during the electropermeable ablation procedure. As further shown, the catheter 200 includes an electrode assembly 220 at the distal end extending from the distal end 206 of the catheter shaft 202.

[0051] In the embodiment, the electrode assembly 220 includes a plurality of energy-delivering electrodes 225, and the electrode assembly 220 is configured to be selectively operable in a first state and a second state. In some cases, in the first state, the electrode assembly 220 is configured to deliver ablation energy to form a circumferential ablation wound having a certain diameter.

[0052] In some embodiments, the electrode assembly 220 includes an inner shaft 203, which extends from and is adapted to retract into the catheter shaft 202. In some cases, the electrode assembly 220 includes a plurality of splines 204 connected to the inner shaft 203 at its distal end 211. In some cases, the electrode assembly 220 further includes a central shaft 203a having a proximal end 211a (overlapping with the distal end 211 of the inner shaft 203) and a distal end 212. In some cases, the plurality of splines 204 are coupled to the distal end 212 of the central shaft 203a. In some embodiments, the electrode 225 includes a plurality of first electrodes 208 and a plurality of second electrodes 210 arranged on the plurality of splines 204. In one example, multiple second electrodes 210 are positioned near the distal end 212 of the central shaft 203a, and multiple first electrodes 208 are positioned near the proximal end 211a of the central shaft 203a.

[0053] In some cases, when operating in the first state, the inner shaft 203 and the central shaft 203a extend from the catheter shaft 202, for example, as shown in Figure 2A. In some cases, in the first state, both a plurality of first electrodes 208 and a plurality of second electrodes 210 are selectively energized and activated to form a relatively large diameter for circumferential ablation injury, for example, used in pulmonary vein isolation (PVI) procedures.

[0054] In some embodiments, when operating in the second state, the inner shaft 203 and central shaft 203a are retracted at least partially into the catheter shaft 202 so that all or some of the plurality of first electrodes 208 are retracted into the catheter shaft 202, for example as shown in Figure 2B. In some cases, in the second state, the plurality of first electrodes 208 are deactivated (for example, by electrically disconnecting the first electrodes 208 from any pulse generator circuit), and the plurality of second electrodes 210 are activated and used to generate local ablation damage by electroporation.

[0055] The ablation catheter 200 has a longitudinal axis 222. As used herein, the longitudinal axis refers to a line passing through the centroid of the cross-section of the object. In embodiments, a plurality of splines 204 form a cavity 224. The plurality of splines 204 form a cavity 224a in a first state and a cavity 224b in a second state. In embodiments, the volume of cavity 224a is greater than the volume of cavity 224b. In some embodiments, in the first state, the maximum cross-sectional area of ​​cavity 224a approximately perpendicular to the longitudinal axis 222 has a diameter d1. In some embodiments, in the second state, the maximum cross-sectional area of ​​cavity 224b approximately perpendicular to the longitudinal axis 222 has a diameter d2. In some cases, diameter d1 is greater than diameter d2.

[0056] In some examples, diameter d1 is in the range of 20 to 35 millimeters. In a particular example, diameter d1 is in the range of 10 to 25 millimeters. In some examples, diameter d2 is in the range of 5 to 16 millimeters. In some examples, diameter d2 is in the range of 5 to 16 millimeters. In one example, diameter d1 is 30% to 100% larger than diameter d2. In one example, diameter d1 is at least 30% larger than diameter d2. In one example, diameter d1 is at least 20% larger than diameter d2. In one example, diameter d1 is at least 100% larger than diameter d2 (i.e., at least twice as large as diameter d2). In one example, diameter d1 is at least 150% larger than diameter d2 (i.e., at least 2.5 times as large as diameter d2).

[0057] In some cases, the first electrode group 208 is positioned on or near the outer periphery of the multiple splines 204, and the second electrode group 210 is positioned near the distal end 212 of the catheter 200. In some cases, the first electrode group 208 is called the proximal electrode, and the second electrode group 210 is called the distal electrode, with the distal electrode 210 positioned closer to the distal end 212 of the electroperforation ablation catheter 200 than the proximal electrode 208. In some implementations, the electrode 225 may include a thin film of conductive ink or optical ink. The ink may be polymer-based. The ink may further include materials such as carbon and / or graphite in combination with the conductive material. The electrode may also include biocompatible low-resistance metals such as silver, silver flakes, gold, and platinum, which are further radiopaque.

[0058] Each electrode in the first electrode group 208 and each electrode in the second electrode group 210 conducts electricity and is configured to be operably connected to a controller (e.g., controller 90 in Figure 1) and an ablation energy generator (e.g., electroporation generator 130 in Figure 1). In embodiments, one or more electrodes in the first electrode group 208 and the second electrode group 210 include a flex circuit. In some cases, a plurality of first electrodes 208 are individually controllable. In some cases, a plurality of second electrodes are individually controllable. In some cases, all or some of the plurality of first electrodes 208 are deactivated in a second state. In some cases, some of the plurality of second electrodes 210 are deactivated in a second state.

[0059] The electrodes in the first electrode group 208 are spaced apart from the electrodes in the second electrode group 210. The first electrode group 208 includes electrodes 208a to 208f, and the second electrode group 210 includes electrodes 210a to 210f. Furthermore, the electrodes in the first electrode group 208, such as electrodes 208a to 208f, are spaced apart from each other, and the electrodes in the second electrode group 210, such as electrodes 210a to 210f, are spaced apart from each other.

[0060] The spatial relationships and orientations of the electrodes within group 208 of the first electrodes, and the spatial relationships and orientations of the electrodes within group 210 of the second electrodes, relative to other electrodes on the same catheter 200, are known or can be determined. In the embodiment, the spatial relationships and orientations of the electrodes within group 208 of the first electrodes, and the spatial relationships and orientations of the electrodes within group 210 of the second electrodes, relative to other electrodes on the same catheter 200, are constant once the catheter is deployed.

[0061] With respect to the electric field, in the embodiment, each electrode in the first electrode group 208 and each electrode in the second electrode group 210 may be selected to be an anode or a cathode, thereby allowing the electric field to be set between any two or more electrodes in the first and second electrode groups 208 and 210. Also in the embodiment, each electrode in the first electrode group 208 and each electrode in the second electrode group 210 may be selected to be anode or cathode or a diphase electrode, thereby allowing the electrode to switch between anode and cathode or alternate between them. With respect to the electric field, in the embodiment, each electrode group in the first electrode group 208 and each electrode group in the second electrode group 210 may be selected to be an anode or a cathode or a diphase electrode, thereby allowing the electric field to be set between any two or more electrode groups in the first and second electrode groups 208 and 210.

[0062] In embodiments, electrodes in the first electrode group 208 and the second electrode group 210 may be selected to be biphase electrodes, so that during a pulse train including a biphase pulse train, the selected electrodes switch or alternate between anode and cathode, and the electrodes do not have a single-phase delivery where one is always the anode and the other is always the cathode. In some cases, electrodes in the first and second electrode groups 208 and 210 may form an electric field together with the electrode(s) of another catheter. In such cases, electrodes in the first and second electrode groups 208 and 210 may be the anode or cathode of the electric field.

[0063] Furthermore, as described herein, electrodes are selected to be either anodes or cathodes, but it should be understood without further mention throughout this disclosure that electrodes may be selected to be biphasic electrodes, switching or alternating between anode and cathode. In some cases, one or more electrodes in group 208 of the first electrode are selected to be cathodes, and one or more electrodes in group 210 of the second electrode are selected to be anodes. In embodiments, one or more electrodes in group 208 of the first electrode may be selected as cathodes, and one or more other electrodes in group 208 may be selected as anodes for the first electrode. Furthermore, in embodiments, one or more electrodes in group 210 of the second electrode may be selected as cathodes, and one or more other electrodes in group 210 may be selected as anodes for the second electrode.

[0064] In some cases, the first group of electrodes 208 is positioned proximal to the maximum outer circumference (d1) of the catheter spline 204, and the second group of electrodes 210 is positioned distal to the maximum outer circumference of the catheter spline 204. In some embodiments, additional electrodes (i.e., mapping electrodes) may be added to each of the multiple splines 204.

[0065] Figures 3A to 3C are schematic diagrams showing an ablation catheter 300 that can be used for electroperforation ablation, including irreversible electroperforation ablation, according to embodiments of the subject matter of this disclosure.

[0066] Figure 3A shows catheter 300A in a first state called the first operating mode. In some embodiments, catheter 300A includes an electrode assembly 301A. The electrode assembly 301A has a first shape called a basket shape in Figure 3A. Catheter 300 includes a catheter shaft 302. The electrode assembly includes a plurality of splines 304 coupled to the catheter shaft 302 at the distal end 306 of the catheter shaft 302. The catheter splines 304 include a plurality of electrodes 310 arranged on the catheter splines 204. Each of the electrodes in the plurality of electrodes 310 is configured to conduct electricity and to be operably connected to an electroporation generator (e.g., electroporation generator 130 in Figure 1). In embodiments, one of the electrodes in the plurality of electrodes 310 includes metal.

[0067] The electrode assembly 301A has a proximal end 316 close to the distal end 306 of the catheter shaft 302 and a distal end 314 further away from the distal end 306 of the catheter shaft 302. As shown, the catheter shaft 302 defines a longitudinal axis 312, and the multiple splines 304 are arranged in a curved shape between the distal end 314 and the proximal end 160. In the embodiment, each spline 304 of the electrode assembly 301 in the first state is arranged as a curve without a turning point. In some embodiments, each spline 304 has a curvature less than a predetermined degree. For example, each spline 304 has a curvature of less than 45°.

[0068] Figure 3B shows end views of catheters 300B and 300C in a second state called the second operating mode, and Figure 3C shows a side view of catheter 300C in the second state. In embodiments, each of the plurality of splines 304 includes one or more electrodes 310 positioned thereon. For example, as shown, spline 304a includes four electrodes. In some embodiments, each of the plurality of splines 304 may include more than four electrodes. In some embodiments, each of the plurality of splines 304 may include fewer than four electrodes. As can be understood by those skilled in the art, the number of electrodes on each spline, including the spacing between each electrode, can be adjusted. The catheter shaft may further include a cap 324. In embodiments, the cap 324 is non-traumatic to reduce trauma to tissue.

[0069] Each of the illustrated splines 304 has a similar size, shape, and spacing between adjacent electrodes 310 on the spline 304. In other embodiments, the size, shape, and spacing between adjacent electrodes 310 on the spline 304 may differ. In some embodiments, the thickness and length of each of the splines 304 may vary based on the number of electrodes and the spacing between each electrode on the spline 304. The splines 304 may be made from similar but different materials, and their thickness or length may vary.

[0070] As shown, each of the multiple splines 304 is positioned on the petal-shaped curve 322 in a second state where the distal end 314 of the electrode assembly 301 is adjacent to the proximal end 316 of the electrode assembly 301. Each of the multiple splines 304 passes through the distal end 306 of the catheter shaft 302 and can be connected to the catheter shaft 302 within the catheter shaft lumen. The distal end of each of the multiple splines 304 can be connected to the cap 324 of the catheter 300. In some embodiments, one or more curves 322 are electrically isolated. As shown, the petal-shaped curve 322 includes a turning point.

[0071] In some embodiments, the catheter 300B includes an electrode assembly 301B arranged in a second shape, or a shape referred to as a flower shape, as shown in Figure 3B. In some embodiments, the catheter 300C includes an electrode assembly 301C arranged in a second shape, as shown in Figure 3C. As shown, each of the multiple splines 304 may include a flexible curve so as to rotate or twist and bend to form a petal-shaped curve 322. The minimum radius of curvature of the splines in the petal-shaped configuration may be in the range of about 7 mm to about 25 mm. For example, the splines 304 may form an electrode assembly 301 in the distal portion of the catheter 300 and may be configured to deform between a first shape in which the set of splines is arranged approximately parallel to the longitudinal axis of the catheter 300 and a second shape in which the set of splines rotates or twists and bends around the longitudinal axis of the catheter 300 and is generally biased away from the longitudinal axis of the catheter. In the first configuration, each spline in the set of splines 304 may lie in a plane with respect to the longitudinal axis 312. In the second configuration, each spline in the set of splines 304 may be biased away from the longitudinal axis 312 to form a petal-like curve 322 positioned approximately perpendicular to the longitudinal axis 312. In this way, the set of splines 304 is twisted and bent, biased away from the longitudinal axis 312 of the catheter 300, and thus allows the splines 304 to more easily conform to the geometric shape of the endocardial space, particularly adjacent to the opening of the lung orifice. The second configuration may resemble a flower shape from an end view, for example, as shown in Figure 3B. In some embodiments, each spline in the set of splines in the second configuration may be twisted and bent to form a petal-like curve that, when viewed from the front, exhibits an angle of curvature between the proximal and distal ends of the curve that is close to 180 degrees.

[0072] The spline set may also be configured to deform from a second shape to a third shape, and the spline set 304 may be pressed against (e.g., in contact with) target tissue, such as the tissue surrounding the pulmonary vein orifice. The multiple splines 304 may form a shape that is generally parallel to the longitudinal axis 312 of the catheter shaft 302 when unfolded, and when fully unfolded they may be wound (e.g., spirally wound and twisted) around an axis (not shown) parallel to the longitudinal axis 312, forming any intermediate shapes (such as a cage or barrel) between the various shapes.

[0073] Figures 4A and 4B show examples of a graphical user interface 400 according to embodiments of the subject matter of this disclosure. As described above, an electroporation catheter system (e.g., electroporation device 60 in Figure 1) including a controller (e.g., controller 90 in Figure 1) generates a graphical representation 403 of the electric field that can be generated using the electroporation catheter, based on a model of the electric field, and overlays the graphical representation 403 of the electric field onto an anatomical map 402 of the patient's heart. This graphical representation can assist the user in planning ablation by irreversible electroporation and / or provide real-time visual feedback on the progress of the ablation so that the user can adjust the ablation plan accordingly. In embodiments, the controller (e.g., controller 90 in Figure 1) is configured to display these and other graphical representations in the overlay of the graphical representation of the electric field on the anatomical map on a display (e.g., display 92 in Figure 1).

[0074] In some embodiments, the controller (e.g., controller 90 in Figure 1) is configured to display only three-dimensional surfaces without thickness in the superposition of graphical representations of the electric field on the anatomical map. In some embodiments (not shown), the graphical representation 403 may include different colors to represent different intensities of the projected electric field. In some embodiments (not shown), the graphical representation 403 may include gradient or vector fields to represent different intensities of the projected electric field.

[0075] As shown, a catheter 405, including an electrode assembly 401, is deployed into a vein of the patient's heart. The graphical user interface includes a graphical representation 406 of the electric field having an ablation effect on the surrounding tissue on an anatomical map 402 of the patient's vein. The axis 410 is the projected axis of the catheter 405, aligned with the axis of the vein (not shown). In some examples, the graphical representation 406 includes an area 407, where the electric field intensity within the area is greater than a predetermined threshold. In some examples, the graphical representation 406 includes an area 407, where the electric field intensity within the area is greater than the threshold for electroporation (e.g., 250 V / cm). In a particular example, the graphical representation 406 includes an area 407, where the electric field intensity within the area is greater than the threshold for irreversible electroporation (e.g., 400 V / cm). The graphical user interface 400 includes a representation of the catheter 405, a longitudinal axis 410, an anatomical map 402, and the electric field predicted as a function of the unfolded shape of the catheter 405, thereby enabling the user to advance or navigate the catheter 405 during a treatment session without requiring fluoroscopy.

[0076] The electrode assembly includes a plurality of splines 404, each of which includes one or more electrodes 408 positioned on the splines. The one or more electrodes 408 may include an ablation electrode and / or a mapping electrode. In some embodiments, one or more electrodes may be positioned on other components of the catheter 405, such as an end cap at the distal end 416 and a catheter shaft (not shown).

[0077] In some embodiments, Figures 4A and 4B are updated in real time and show the position of the catheter and the electric field generated by the catheter 405. In certain embodiments, the graphical representation 406 of the electric field includes one or more indicators, including, for example, electric field strength, tissue contact, and colors representing location. In some examples, the graphical representation 406 may have a different color than the previous graphical representation 406 if the catheter 405 has moved from a previous location in a previous treatment session associated with a previous graphical representation to a new location in the current treatment session. In certain embodiments, the graphical representation 406 may have a different color than the previous graphical representation 406 if the catheter 405 has rotated from a previous treatment session associated with a previous graphical representation. In some examples, the colors are grayscale. In certain embodiments, Figures 4A and 4B are presented side by side to show changes in a treatment session. In some embodiments, the electric field of the catheter 405 is generated based on the known relative locations of electrodes within the catheter.

[0078] Figure 4A shows a catheter 405 in a first state, where, as a first shape (e.g., basket shape), a plurality of splines 404 are arranged curvilinearly between the proximal end 414 and the distal end 416 of the electrode assembly 401. Figure 4B shows a catheter 405 in a second state, where the plurality of splines 404 are arranged in a petal-like curve, as a second shape (e.g., flower shape). In some embodiments, the splines 404 are electrically insulated. When the electrode assembly 401 is in the first shape, the splines on the electrode assembly 401 may be arranged approximately parallel to the longitudinal axis of the catheter 405. In the first shape, each spline may be in a plane with respect to the longitudinal axis 410.

[0079] In some embodiments, as shown in Figures 4A and 4B, the first shape of the electrode assembly 401 when the catheter 405 is in a first state is not similar to the second shape of the electrode assembly 401 when the catheter 405 is in a second state. In other embodiments shown in Figures 2A and 2B, the volume of the electrode assembly shape in the first state is different from the volume of the spline shape in the second state.

[0080] As described above, the controller (e.g., controller 90 in Figure 1) is configured to control the electroporation generator (e.g., electroporation generator 130 in Figure 1) to generate electrical pulses and deliver the treatment to a target area within the patient's heart chambers. In some embodiments, the controller may be configured to generate a first graphical representation of the electric field of multiple electrodes in a first state based on a first model of the electric field, and a second graphical representation of the electric field of multiple electrodes in a second state based on a second model of the electric field, and to superimpose the first and second graphical representations of the electric field onto an anatomical map of the patient at the target site where the catheter 405 is deployed.

[0081] When the electrode assembly 401 is in the second shape, the splines on the electrode assembly 401 rotate or twist and bend around the longitudinal axis of the catheter 405, and are generally biased away from the longitudinal axis of the catheter 405. In the second shape, each spline may be biased away from the longitudinal axis 410 to form a petal-like curve positioned approximately perpendicular to the longitudinal axis 410. In this way, the set of splines 304 is twisted and bent and biased away from the longitudinal axis 410, thus allowing the splines to more easily conform to the geometric shape of the endocardial space, particularly adjacent to the opening of the lung orifice. The second shape may resemble the shape of a flower from an end view, for example, as shown in Figure 4B. In some embodiments, each spline in the set of splines in the second shape may twist and bend to form a petal-like curve that, when viewed from the front, exhibits an angle of curvature between the proximal and distal ends of the curve that is close to 180 degrees.

[0082] In addition to those shown in Figures 4A and 4B, the spline set may further be configured to deform from a second shape to a third shape, and the splines may be pressed against (e.g., in contact with) target tissue, such as the tissue surrounding the pulmonary vein orifice. The splines form a shape that is generally parallel to the longitudinal axis 410 when unfolded, and when fully unfolded they may be wound (e.g., spirally wound and twisted) around an axis (not shown) parallel to the longitudinal axis 410, and may form any intermediate shapes (such as a cage or barrel) between the various shapes.

[0083] Figures 5A to 5C show a software widget 500 that facilitates the planning and / or execution of an ablation treatment according to a particular embodiment of the present disclosure. In the implementation, the software widget 500 is implemented by a set of software instructions executed by one or more processors. As shown, the numbers 502, 504 represent the number of ablation treatment sessions (e.g., Session 1, Session 2). 502 indicates a previous treatment session, and 504 indicates the current treatment session being performed by the user. In some examples, several rectangles 506, 508 located outside the circle 515 represent the locations of the catheter electrodes in a cross-sectional view. In a particular example, several rectangles 506, 508 located outside the circle represent the locations of splines on the electrode assembly as viewed from the cross-sectional view. 506 represents the location of the spline during the first (past) session, and 508 represents the location of the spline during the second (current) session. In some examples, as shown, the catheter is rotated 25 degrees between the first and second sessions. In other examples not shown, the rotation angle may be greater or less than 25 degrees.

[0084] In the embodiment, the catheter representation 510 indicates the relative position of the electrode assembly between sessions. As shown in Figure 5A, the catheter representation 510 with multiple teeth 511 located inside the circle 515 indicates that the electrode assembly is located more distally along the patient's vein compared to a previous application / session. As shown in Figure 5B, the solid circle 5155 indicates that the position of the electrode assembly remains substantially the same within the patient's vein compared to a previous application / session. As shown in Figure 5C, the dashed circle 515 indicates that the position of the electrode assembly is located more sinusoidal (antral) or proximal along the patient's vein or cardiac chamber compared to a previous application / session.

[0085] In some embodiments, the software widget 500 includes an alignment indicator 512. In some examples, as shown in Figures 5A and 5C, the alignment indicator 512 is an arrow or dashed arrow indicating the misalignment of the projected axis of the catheter (e.g., the axis defined by the catheter shaft) with respect to the axis of the target ablation area in the patient's vein or cardiac chamber. The alignment indicator 512 may have various shapes and / or colors. As shown in Figure 5B, the alignment indicator 512 is a dot indicating that the projected axis of the catheter shaft is substantially aligned with the axis of the target ablation area in the patient's vein or cardiac chamber.

[0086] In some embodiments, the controller (e.g., controller 90 in Figure 1) may be configured to generate and display a software widget 500 that includes a representation of the catheter and a display of one or more treatment sessions of electroporation ablation (not shown in Figures 5A-5C). In embodiments, the software widget includes a display that identifies a particular treatment session from one or more treatment sessions. In some embodiments, the software widget includes a cross-sectional view of the catheter (e.g., catheter 105 in Figure 1). The controller may be further configured to generate and display a graphical representation of the electric fields of multiple electrodes based on a model of the electric field.

[0087] In some embodiments, the software widget 500 includes an alignment indicator 512 that represents the axial relationship between the catheter and the target ablation area of ​​the electroporation ablation treatment. In some examples, the representation of the catheter 105 includes a first representation of the catheter at a first time and a second representation of the catheter at a second time. The first and second representations may show the difference between the catheter at the first time and the catheter at the second time. The shown difference includes at least one of the following: a difference in shape, a difference in rotation angle, and a difference in location. In some embodiments, the software widget further includes an electric field display that represents an electric field.

[0088] Figures 6A and 6B show graphical representations of side-by-side software widgets and electric fields according to embodiments of the subject matter of this disclosure. As shown, the catheter 600, including the electrode assembly 601, is deployed into the patient's cardiac chambers. A display (e.g., display 92 in Figure 1) shows a graphical representation 606 of the electric field with the effect of ablation on the surrounding tissue on an anatomical map 602 of the patient's cardiac chambers. The axis 610 is the projected axis of the catheter 600, aligned with the axis of the target ablation area (not shown).

[0089] The electrode assembly includes a plurality of splines 604 and one or more electrodes 608 positioned on each of the plurality of splines 604. The one or more electrodes 608 may include an ablation electrode and / or a mapping electrode. Each of the plurality of splines 604 may include one or more additional electrodes other than the electrodes 608.

[0090] Figure 6A shows the catheter 600 in a first state, where multiple splines 604 are arranged in a basket shape between the distal end 614 and the proximal end 616 of the electrode assembly 601. Figure 6B shows the catheter 600 in a second state, where multiple splines 604 are arranged in a flower shape with pedal-like loops. In some embodiments, the loops are electrically insulated.

[0091] In some embodiments, as shown, the curve shape in the first state is not similar to the loop shape in the second state. In other embodiments shown earlier in Figures 2A and 2B, the shape of the spline in the first state is simply different from the shape of the spline in the second state.

[0092] As described above, the controller (e.g., controller 90 in Figure 1) is configured to control the electroporation generator (e.g., electroporation generator 130 in Figure 1) to generate electrical pulses and deliver treatment to a target area within the patient's vein. In some embodiments, the controller may be configured to generate a first graphical representation of the electric field of multiple electrodes in a first state based on a first model of the electric field, and a second graphical representation of the electric field of multiple electrodes in a second state based on a second model of the electric field, and to superimpose the first and second graphical representations of the electric field onto an anatomical map of the patient at the catheter location.

[0093] In some embodiments, the controller (e.g., controller 90 in Figure 1) may be configured to generate and display a software widget 618 that includes a representation of the catheter 600 and a display of one or more treatment sessions of electropermeable ablation (not shown). The software widget 618 may include any embodiments and configurations as described herein. In embodiments, the software widget includes a display that identifies a particular treatment session out of one or more treatment sessions. In some embodiments, the software widget includes a cross-sectional view of the catheter 600 shown in Figure 6A by line 620. The controller may be further configured to generate and display a graphical representation of the electric fields of multiple electrodes based on a model of electric fields.

[0094] In some embodiments, the software widget 618 includes an alignment indicator representing the axial relationship between the catheter and the target ablation area of ​​the electroporation ablation treatment. In some examples, the representation of the catheter 105 includes a first representation of the catheter at a first time and a second representation of the catheter at a second time. The first and second representations may show the difference between the catheter at the first time and the catheter at the second time. The shown difference includes at least one of the following: a difference in shape, a difference in rotation angle, and a difference in location. In some embodiments, the software widget further includes an electric field indicator (not shown) representing an electric field.

[0095] Figures 7A–7B show examples of electric fields of varying intensities generated by a catheter including an electrode assembly. As shown, the catheter 700 includes a catheter shaft 702 and an electrode assembly 701. The electrode assembly includes a plurality of splines 704 connected to the distal end 706 of the shaft 702. Each of the plurality of splines 704 includes one or more electrodes 708. The catheter shaft 702 defines a longitudinal axis 712 that extends along the length of the shaft 702.

[0096] Figure 7A shows the catheter 700 in a first state in which multiple splines 704 are arranged in a curved shape between the distal end 714 and the proximal end 716 of the electrode assembly 701. As shown, the proximal end 716 of the electrode assembly 701 extends from the catheter shaft 702 of the flexible catheter 700.

[0097] Figure 7B shows the catheter 700 in a second state, where multiple splines 704 are arranged in a petal-like curve between the distal end 714 and the proximal end 716 of the electrode assembly 701. As shown, the distal end 714 is further away from the proximal end 716 of the electrode assembly 701 in the first state compared to the second state. Therefore, the depth of the electric field (L1) generated in the first state is greater than the depth of the electric field (L2) generated in the second state. Similarly, the width of the electric field (W1) generated in the first state is shorter than the width of the electric field (W2) generated in the second state.

[0098] The inner electric field 718 is located closer to the electrode assembly 701 and is relatively stronger than the outer electric field 720, which is located further away from the electrode assembly 701. In some examples, the inner electric field 718 may be about 400 volts / cm or more. In some cases, the outer electric field 720 may be about 250 volts / cm or more, but less than 400 volts / cm. In some embodiments, the inner electric field 718 may be strong enough to perform irreversible electroporation. In some embodiments, the outer electric field 720 may be only strong enough to perform reversible electroporation.

[0099] Figure 8 is a flowchart illustrating a method for planning irreversible electroporation ablation according to an embodiment of the subject matter of this disclosure. While the method is described herein in relation to the catheters mentioned above, any suitable electroporation catheter may be used in this method. The embodiments of the method may be performed, for example, by an electrophysiological system or controller (e.g., system 50 in Figure 1, controller 90 in Figure 1). One or more steps of the method are optional and / or can be modified by one or more steps of other embodiments described herein. In addition, one or more steps of other embodiments described herein may be added to the method.

[0100] In 800, the method includes the step of determining the location of an electrode in the patient relative to cardiac tissue after the catheter has been inserted into the patient, and in 802, the method includes the step of determining the characteristics of cardiac tissue near or surrounding the catheter in the patient.

[0101] In 804, the method includes the step of modeling the electric field that may be generated by the catheter in one of a plurality of states. In some embodiments, the method also includes the step of selecting an electrode that is deemed most suitable for ablating target cardiac tissue by electroporation, including ablation of target surface tissue and deeper tissue. In embodiments, this includes the step of providing a user input, such as voltage amplitude. In embodiments, the method also includes the step of modeling the electric field that may be generated by catheter electrode assemblies of different shapes. In some examples, the catheter electrode assembly has a shape for a first state that is different from the shape for a second state. In embodiments, the catheter electrodes have known relative positions when the catheter is in various states.

[0102] In some embodiments, in 804, the method includes the step of a controller generating a first graphical representation of a first electric field based on a first model of the electric field, using electrodes on a catheter in a first state, wherein the catheter includes an electrode assembly having a first shape when the catheter is in the first state. In some embodiments, in 804, the method includes the controller generating a second graphical representation of a second electric field based on a second model of the electric field, using electrodes on a catheter in a second state, wherein the catheter includes an electrode assembly having a second shape when the catheter is in the second state, the second shape being different from the first shape. In some examples, the second shape is not similar to the first shape.

[0103] In some embodiments, the method further includes the step of generating a display of the difference between a first graphical representation of a first electric field and a second graphical representation of a second electric field. In 806, the method includes the step of estimating the shape of the electric field at a particular electric field intensity, including, for example, the surface area and depth of cardiac tissue that is affected or may be affected by the electric field. In embodiments, the method includes the step of determining the electric field intensity in different parts of cardiac tissue. In some examples, the electric field is determined with some degree of uncertainty. In embodiments, this includes the step of determining an electrical pulse to generate an electric field between selected electrodes in order to ablate the tissue by irreversible electroporation. In embodiments, this includes the step of determining an electrical pulse to generate an electric field between selected electrodes in order to ablate the tissue by irreversible electroporation, based at least partially on the known relative locations of the electrodes. Also in embodiments, this includes the step of determining dosing parameters for the electric field, such as the electric field intensity and the length of time the electric field is applied to the cardiac tissue.

[0104] In 808, the method includes the step of generating a graphical representation of an electric field that can be generated using selected electrodes on a catheter, based on a model of the electric field, using a controller 90. In embodiments, the method includes the step of generating a graphical representation of an electric field based on the characteristics of the catheter, the position or location of the catheter in the patient, and the characteristics of the cardiac tissue surrounding the catheter in the patient.

[0105] In 810, the method includes the step of displaying a graphical representation of the electric field and an anatomical map of the patient on a display such as a display 92, which may be used to assist in planning an ablation by electroperforation and / or to modify the ablation plan in real time according to the displayed representation. In embodiments, this includes the step of overlaying a graphical representation of the electric field of interest onto an anatomical map of the heart. In embodiments, the step of displaying the graphical representation includes displaying the electric field intensity based on the electrical pulse parameters of the electrical pulses supplied to a selected electrode among the electrodes.

[0106] In some embodiments, the method in 810 includes the step of presenting a first graphical representation of the electric field and an anatomical map of the patient adjacent to the target location on a display. In some embodiments, the method in 810 includes the step of presenting a second graphical representation of the electric field and an anatomical map of the patient adjacent to the target location on a display.

[0107] In embodiments, the graphical representation may include the steps of displaying one or more of the following: electric field lines in a graphical representation of the electric field on an anatomical map; threshold lines of electric field intensity in a graphical representation of the electric field on an anatomical map; markings where the threshold lines of electric field intensity intersect with surrounding tissue; a predicted zone for reversible electroperforation; a predicted zone for irreversible electroperforation; markings where the electric field intersects with previously created damage; and a predicted damage on an anatomical map.

[0108] In 812, the method includes the step of generating and displaying a software widget (e.g., the software widget 500 in Figures 5A to 5C) to facilitate ablation planning. In embodiments, the software widget includes a representation of one or more of the following: the catheter, the catheter's location, the catheter's rotation angle, the progress of the treatment session, the catheter's alignment, and other relevant ablation information.

[0109] In some embodiments, the method may further include the step of generating a software widget that includes a second representation of the catheter and a display of one or more treatment sessions of electroporation ablation performed by the catheter. In some embodiments, the method may further include the step of presenting the software widget on a display.

[0110] The method returns to 800 for the next treatment session. In embodiments, the method also includes the step of dynamically changing the graphical representation of the electric field over the treatment session based on one or more of the following: changes in the position of the catheter relative to the surrounding tissue, changes in the catheter, changes in the pulse parameters provided to the electrodes of the catheter, and changes in the measured impedance values ​​of the surrounding tissue, by the controller.

[0111] Various modifications and additions can be made to the exemplary embodiments described without departing from the scope of the present invention. For example, while the embodiments described above refer to specific features, the scope of the present invention also includes embodiments having different combinations of features, and embodiments that do not include all of the described features. Accordingly, the scope of the present invention is intended to encompass all such alternative forms, modifications, and variations that fall within the claims, along with all their equivalents.

Claims

1. A catheter comprising an electrode assembly and multiple states, wherein the electrode assembly has a first shape when the catheter is in a first state among the multiple states, and the electrode assembly has a second shape when the catheter is in a second state among the multiple states, the second shape being different from the first shape, the electrode assembly comprising multiple electrodes, the first shape including a basket shape, and the second shape including a flower shape, It is a controller, Based on a first model of the electric field, when the catheter is in the first state and deployed in close proximity to the target site, a first graphical representation of the first electric field is generated that exceeds the threshold for electroporation generated by the plurality of electrodes. Based on a second model of the electric field, when the catheter is in the second state and deployed in close proximity to the target location, a second graphical representation of the second electric field is generated that exceeds the threshold for electroporation generated by the plurality of electrodes. In a graphical user interface, the first graphical representation of the first electric field and the second graphical representation of the second electric field are superimposed on an anatomical map of the patient adjacent to the target location. A system for electroporation ablation, comprising a controller configured to dynamically update the graphical representation in real time based on changes in the position of the catheter relative to the surrounding tissue.

2. The system according to claim 1, wherein the volume of the second shape is smaller than the volume of the first shape.

3. The system according to claim 1, wherein the catheter includes a catheter shaft defining a longitudinal axis, the electrode assembly includes a plurality of splines, a proximal end, and a distal end, at least a portion of the plurality of electrodes are arranged on the plurality of splines, and the proximal end of the electrode assembly extends from the catheter shaft.

4. The system according to claim 3, wherein each of the plurality of splines is arranged curvilinearly around the longitudinal axis between the distal end and the proximal end of the electrode assembly when the catheter is in the first state.

5. The system according to claim 3, wherein the plurality of splines are arranged in a petal-like curve when the catheter is in the second state.

6. The system according to claim 1, wherein the controller is further configured to generate a display of the difference between the first graphical representation of the first electric field and the second graphical representation of the second electric field.

7. The system according to claim 1, wherein the first graphical representation of the first electric field includes one or more first areas, and the magnitude of the electric field intensity of the first electric field within the one or more first areas is greater than a predetermined threshold.

8. The system according to claim 7, wherein the second graphical representation of the second electric field includes one or more second areas, and the magnitude of the electric field intensity of the second electric field within the one or more second areas is greater than a predetermined threshold.

9. The system according to claim 1, wherein the first graphical representation includes a first representation of the catheter.

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