Apparatus, system, and method for preventing arc discharge between electrodes in medical procedures

Abstract

An energy delivery assembly probe, formed from a long energy delivery member, has one or more electrodes defined along the energy delivery region of the energy delivery member. An electrode-defining insulating member is provided to cover the energy delivery member and defines at least a first electrode to be separated from a second electrode. One or more of the electrodes and / or insulating members are configured and / or have the characteristics or properties to reduce / minimize / eliminate arc discharge between or across the electrodes of the energy delivery assembly.

Description

Technical Field

[0001] The present disclosure generally relates to medical devices, assemblies, systems, and methods for applying energy to a patient for therapeutic purposes and the like. Specifically, the present disclosure relates to medical devices, assemblies, systems, and methods for applying electrical energy, such as therapeutic electrical pulses, to a patient. More specifically, the present disclosure relates to various devices, assemblies, systems, and methods for electroporation procedures. Even more specifically, the present disclosure relates to bipolar devices, assemblies, systems, and related methods for applying energy, such as electrical energy, for electroporation methods and the like. This application claims the benefit of priority of U.S. Provisional Patent Application No. 63 / 472,711, filed on Jun. 13, 2023, the entire disclosure of which is incorporated herein by reference for all purposes.

Background Art

[0002] Various devices, assemblies, systems, and methods exist for energy-based medical procedures and / or therapeutic protocols. For example, various topical treatment devices are configured to reduce the volume of target tissue or eliminate malignant cells by applying energy. Various techniques for such treatments rely on thermal effects such as radiofrequency ("RF") heating, microwave heating, cryoablation, and high-intensity focused ultrasound ("HIFU"). In contrast, electroporation and / or irreversible electroporation are non-thermal therapies and have significant potential advantages over thermal modalities. Energy can be applied to perform electroporation and / or irreversible electroporation ("IRE") as a mode of treating various conditions and / or diseases using an electric field to disrupt and / or alter the properties of biological cellular material. For example, an applied electric field can significantly increase the conductivity and permeability of plasma within the cell membrane. The applied energy creates pathways / pores in the cell wall and / or membrane near the device from which the energy is applied (e.g., near the electrodes, probes, etc., of that device). Electric fields disrupt homeostasis and, in the case of IRE, kill cells by apoptosis and / or necrosis. Advances in this technology have led to bipolar probes (typically equipped with two electrodes separated by an insulator) to mitigate certain effects of exposure to electric fields (e.g., muscle stimulation that can lead to muscle contraction, cardiac interference, etc.). Once placed within a target site (e.g., a tumor), the device is operated by generating an electric field between and / or around its electrodes for various therapeutic procedures. One challenge with bipolar probes is the potential for arc discharge from one electrode to the other. Arc discharge can negatively impact therapeutic efficiency and effectiveness. There remains a need to at least reduce or mitigate the formation of unintended or undesirable electric field concentration. Furthermore, there is a need to reduce, preferably prevent, the occurrence of arc discharge. [Overview of the Initiative]

[0003] This summary of the invention is provided in a simplified form to introduce the selection of concepts that will be described in more detail below in embodiments for carrying out the invention. This summary is not intended to necessarily identify any important or essential features of the claimed subject matter, nor is it intended to be an aid in determining the scope of the claimed subject matter. A person skilled in the art will understand that each of the various aspects and features of the disclosure may be used advantageously, in some cases separately, or in other cases in combination with other aspects and features of the disclosure, whether or not they are described in this summary. No limitation on the scope of the claimed subject matter is intended by the inclusion or exclusion of elements, components, etc., in this summary.

[0004] According to various principles of the present disclosure, an energy delivery assembly includes an energy delivery member formed of a conductive material, an electrode-defining insulating member positioned to cover a portion of the energy delivery member and defining a first electrode separated from the second electrode, and at least one arc-reducing interface between the electrode-defining insulating member and one of the adjacent first and second electrodes.

[0005] In some embodiments, the arc reduction interface includes a region having a modified shape in at least one of the electrode-defining insulating member and the adjacent one of the first and second electrodes. In some embodiments, the arc reduction interface has the form of a chamfer or fillet along the interface between the electrode-defining insulating member and the adjacent one of the first and second electrodes. Additionally or alternatively, in some embodiments, the arc reduction interface has the form of a rolled wall of the first electrode adjacent to the electrode-defining insulating member. In some embodiments, the arc reduction interface has the form of a thickness in the electrode-defining insulating member adjacent to the adjacent one of the first and second electrodes being reduced with respect to an intermediate region of the electrode-defining insulating member spaced apart from the adjacent one of the first and second electrodes. Additionally or alternatively, in some embodiments, the arc reduction interface has the form of a discontinuity in the electrode-defining insulating member adjacent to at least one of the adjacent one of the first and second electrodes. In some embodiments, a slot for defining the discontinuity is provided in the electrode defining insulating member.

[0006] Additionally or alternatively, at least one of the first electrode and the second electrode has an end adjacent to the electrode-defining insulating member and an end spaced away from the electrode-defining insulating member, and an echo-generating feature portion is provided closer to the at least one end of the first electrode and the second electrode spaced away from the electrode-defining insulating member than to the at least one end of the first electrode and the second electrode adjacent to the electrode-defining insulating member, and the at least one end of the first electrode and the second electrode adjacent to the electrode-defining insulating member that does not have an echo-generating feature portion defines the arc reduction interface.

[0007] Additionally or alternatively, the arc-reducing interface is formed by doping at least one region of the electrode-defining insulating member to create a gradient in electrical conductivity between the adjacent one of the first and second electrodes and the electrode-defining insulating member.

[0008] Additionally or alternatively, the arc reduction interface includes a non-insulating additional member between the electrode defining insulating member and the adjacent one of the first and second electrodes, wherein the non-insulating additional member has an electrical conductivity lower than that of the adjacent one of the first and second electrodes.

[0009] Additionally or alternatively, the arc-reducing interface includes a coating that covers one of the adjacent electrodes of the first and second electrodes. Additionally or alternatively, the first electrode and the second electrode are collinear, defining the energy delivery assembly as a linear bipolar probe.

[0010] According to various principles of this disclosure, an energy delivery system includes an energy delivery assembly. The energy delivery assembly includes an energy delivery member formed of a conductive material, an electrode-defining insulating member positioned to cover a portion of the energy delivery member and defining a first electrode separated from a second electrode, and at least one arc-reducing interface between the electrode-defining insulating member and one adjacent of the first and second electrodes. The system further includes a power connector configured to deliver energy along the first and second electrodes by delivering energy to the energy delivery assembly and then to the energy delivery member.

[0011] In some embodiments, the arc reduction interface includes a region having a modified shape in at least one of the electrode defining insulating member and one of the adjacent electrodes of the first and second electrodes.

[0012] Additionally or alternatively, at least one of the first electrode and the second electrode has an end adjacent to the electrode-defining insulating member and an end spaced away from the electrode-defining insulating member, and an echo-generating feature portion is provided closer to the at least one end of the first electrode and the second electrode spaced away from the electrode-defining insulating member than to the at least one end of the first electrode and the second electrode adjacent to the electrode-defining insulating member, and the at least one end of the first electrode and the second electrode adjacent to the electrode-defining insulating member that does not have the echo-generating feature portion defines the arc reduction interface.

[0013] Additionally or alternatively, the arc-reducing interface is formed by doping at least one region of the electrode-defining insulating member to create a gradient in electrical conductivity between the adjacent one of the first and second electrodes and the electrode-defining insulating member.

[0014] Additionally or alternatively, the arc reduction interface includes a non-insulating additional member between the electrode defining insulating member and the adjacent one of the first and second electrodes, wherein the non-insulating additional member has an electrical conductivity lower than that of the adjacent one of the first and second electrodes.

[0015] Additionally or alternatively, the arc-reducing interface includes a coating that covers one of the adjacent electrodes of the first and second electrodes. According to various principles of this disclosure, a method for applying electroporation or irreversible electroporation energy includes the use of a multi-electrode energy delivery treatment system having at least a first electrode and a second electrode. The first electrode and the second electrode are defined along the energy delivery member such that the first electrode and the second electrode are separated from each other by an electrode-defining insulating member positioned to cover the energy delivery member of the multi-electrode energy delivery treatment system. In some embodiments, the method includes delivering energy from an energy source to the energy delivery member of the multi-electrode energy delivery treatment system to deliver electroporation or irreversible electroporation energy to the first electrode and the second electrode of the multi-electrode energy delivery treatment system, and reducing arc discharge between the first electrode and the second electrode of the multi-electrode energy delivery treatment system by creating a gradient in electrical conductivity between at least one of the first electrode and the second electrode of the multi-electrode energy delivery treatment system and the electrode-defining insulating member.

[0016] In some embodiments, the method includes creating a conductivity gradient by at least one of the following: modifying the properties of at least one of the first and second electrodes of the multi-electrode energy delivery treatment system; modifying the properties of the electrode-defining insulating member; adding a non-insulating member having an intermediate conductivity less than the conductivity of at least one of the first and second electrodes between the at least one of the first and second electrodes and the electrode-defining insulating member; and coating at least a portion of at least one of the first and second electrodes.

[0017] These and other features and advantages of this disclosure will be readily apparent from the following detailed description. The scope of the claimed invention is set out in the attached claims. The following disclosure is presented with respect to a number of aspects or embodiments, each of which may be claimed separately or in combination with the aspects and features of that embodiment or any other embodiment. [Brief explanation of the drawing]

[0018] [Figure 1] Figure 1 is an elevation view showing an example of an embodiment of an energy delivery treatment system formed according to an aspect of this disclosure. [Figure 1A] Figure 1A is a detail view along detail region 1A of Figure 1, showing further details of an example embodiment of an energy delivery assembly usable in the energy delivery treatment system shown in Figure 1, formed according to various principles of this disclosure. [Figure 2] Figure 2 is an elevation view showing an embodiment of an energy delivery treatment system formed according to an aspect of this disclosure for reducing / minimizing / eliminating arc discharge between electrodes via modified echogenicity functions, etc. [Figure 3] Figure 3 is an elevation view showing an embodiment of an energy delivery treatment system formed according to an aspect of this disclosure for reducing / minimizing / eliminating arc discharge between electrodes via a modified interface between the electrode and an insulating member. [Figure 4] Figure 4 shows elevation and partial cross-sectional views illustrating embodiments of an energy delivery treatment system formed according to an aspect of this disclosure for reducing / minimizing / eliminating arc discharge between electrodes via one or more modified interfaces between electrodes and insulating members. [Figure 5] Figure 5 is an elevation view showing an embodiment of an energy delivery treatment system formed according to an aspect of this disclosure for reducing / minimizing / eliminating arc discharge between electrodes via modified insulating material between electrodes. [Figure 6]FIG. 6 is an elevation view showing an embodiment of an energy delivery treatment system formed in accordance with aspects of the present disclosure for reducing / minimizing / eliminating arc discharge between electrodes via a modified insulating member or the like between the electrodes. [Figure 7] FIG. 7 is an elevation view showing an embodiment of an energy delivery treatment system formed in accordance with aspects of the present disclosure for reducing / minimizing / eliminating arc discharge between electrodes via a modified material or the like between at least one electrode and an insulating member. [Figure 8] FIG. 8 is an elevation view showing an embodiment of an energy delivery treatment system formed in accordance with aspects of the present disclosure for reducing / minimizing / eliminating arc discharge between electrodes via a modified material or the like between at least one electrode and an insulating member. [Figure 9] FIG. 9 is an elevation view showing an embodiment of an energy delivery treatment system formed in accordance with aspects of the present disclosure for reducing / minimizing / eliminating arc discharge between electrodes via an intermediate material or the like between at least one electrode and an insulating member. [Figure 10] FIG. 10 is an elevation view showing an embodiment of an energy delivery treatment system formed in accordance with aspects of the present disclosure for reducing / minimizing / eliminating arc discharge between electrodes via at least one modified electrode or the like. [Figure 11] FIG. 11 is an elevation view showing an embodiment of an energy delivery treatment system formed in accordance with aspects of the present disclosure for reducing / minimizing / eliminating arc discharge between electrodes via at least one modified electrode or the like. [Figure 12] FIG. 12 is an elevation view showing an embodiment of an energy delivery treatment system formed in accordance with aspects of the present disclosure for reducing / minimizing / eliminating arc discharge between electrodes via additional modifications or the like to at least one modified electrode.

MODE FOR CARRYING OUT THE INVENTION

[0019] Non-limiting embodiments of the present disclosure will be described by way of example with reference to the accompanying drawings. The accompanying drawings are schematic and are not intended to be drawn to scale. The accompanying drawings are provided for illustrative purposes only, and the dimensions, positions, orders, and relative sizes reflected in the figures may be changed. For example, the device may be enlarged so that details are distinguishable, but is intended to be reduced, for example, with respect to fitting into a working channel of a delivery catheter or an endoscope. In each figure, the same or substantially the same or equivalent elements are typically labeled with the same reference numerals, and similar elements are typically labeled with similar reference numerals that differ by a multiple of 100, and duplicate descriptions are omitted. For clarity and brevity, not all elements are labeled in all figures, and not all elements of each embodiment are shown if illustration is not necessary for those skilled in the art to understand the present disclosure.

[0020] The following detailed description may be better understood when taken in conjunction with the accompanying drawings in which like reference characters represent like elements. The following detailed description should be read with reference to the drawings illustrating exemplary embodiments. This disclosure is not limited to the specific embodiments described and can be modified. All devices, systems, and methods described herein are examples of devices and / or systems and / or methods implemented in accordance with one or more principles of this disclosure. Each example of an embodiment is provided for illustrative purposes only and is merely an example, not the only way to implement these principles. Accordingly, references to elements, structures, or features in the drawings should be recognized as references to examples of embodiments of this disclosure and should not be understood as limiting this disclosure to any specific element, structure, or feature illustrated. By reading this disclosure, a person skilled in the art will be able to conceive of other examples of ways to implement the disclosed principles. Indeed, it will be apparent to a person skilled in the art that various modifications and variations can be made in this disclosure without departing from the scope or spirit of the subject matter. For example, a feature illustrated or described as part of one embodiment may, when used in conjunction with another embodiment, result in a further embodiment. Accordingly, this subject matter is intended to encompass modifications and variations that fall within the scope of the appended claims and their equivalents.

[0021] This disclosure is described in this application with varying levels of detail. In some instances, details that are not necessary for a person skilled in the art to understand this disclosure, or that would make it difficult to grasp other details, have been omitted. The terms used herein are for the purpose of describing specific embodiments only and are not intended to limit the scope beyond the appended claims. Unless otherwise defined, the technical terms used herein should be understood as generally understood by a person skilled in the art to which this disclosure belongs. All apparatuses and / or methods disclosed and claimed herein can be constructed and carried out in light of this disclosure without undue experimentation.

[0022] As understood herein, “corresponding” is intended to describe the relationship between components, parts, elements, etc., configured to interact with each other or to have other intended relationships. As used herein, “proximal” means the direction or position closest to the user (medical professional, clinician, technician, operator, physician, etc., such terminology is not intended to be limited to these but is used interchangeably herein, including automated controller systems, etc.) and / or the direction or position closest to the delivery device when using the device (e.g., when introducing the device into a patient, or during implantation, placement, or delivery). “Distal” means the direction or position furthest from the user and / or the direction or position furthest from the delivery device when using the device (e.g., when introducing the device into a patient, or during implantation, placement, or delivery). “Longitudinal” means the direction extending along the longer or greater dimension of an element. “Longitudinal axis” means the direction extending along the longitudinal range of an element, but not necessarily a straight line, and does not necessarily maintain a fixed configuration if the element bends or curves. The term "axis" generally refers to a movement along a longitudinal axis. However, it should be understood that references to axes or longitudinal movements relating to the systems or elements described above do not need to be strictly limited to axes and / or longitudinal movements along the longitudinal axis or central axis of the element being referred to. "Center" means dividing the center point at least roughly and / or being roughly equidistant from the periphery or boundary, and "central axis" means, with respect to an opening, a line that divides the center point of the opening at least roughly, and if the opening includes, for example, a tubular element, a column, a channel, a cavity, or a hole, the "central axis" extends longitudinally along the length of the opening. As used herein, the "free end" of an element is the end beyond which such an element does not extend. The terms "at the end," "on the end," "adjacent to the end," or "along the end," etc., can be used interchangeably herein without limitation unless otherwise stated, and are intended to indicate generally relative spatial relationships rather than precisely defined locations.For convenience, terms such as therapy, treatment, diagnosis, procedure, etc., including their various grammatical forms, may be used interchangeably and without intent to limit, and without the exclusion of other terms, unless explicitly stated otherwise. Furthermore, treatment sites, target sites, sites, etc., may also be used interchangeably and without intent to limit. Finally, references to "in" a place or site are intended to include locations within such place or site and / or locations near it (e.g., along, adjacent to, nearby, etc.).

[0023] As used herein, the term “ablation” generally refers to the removal of cells directly or indirectly by supplying energy within an electric field, and may include loss of cellular function, cell lysis, coagulation, protein denaturation, necrosis, apoptosis, and / or removal by irreversible electroporation. “Ablation” may also refer to the creation of damage by ablation. Furthermore, the terms “undesirable tissue,” “target cells,” “affected tissue,” “affected cells,” “tumor,” and “cell mass” may be used herein to refer to cells that have been removed, or are to be removed, entirely or partially by ablation, but are not intended to limit the application of any assembly, system, apparatus, or method described herein. For example, such terms include ablation of both affected cells and certain associated cells, even without explicit indication that such associated cells are affected. Ablation performed by an assembly, system, apparatus, or method described herein may be of cells located around biological lumens, such as blood vessels, tubes, or tubular areas, so that a medical professional can create a margin for excising additional cells by ablation or other methods. According to various principles of this disclosure, the apparatus, assemblies, systems, and methods disclosed herein may be configured to perform ablation via electroporation and / or IRE.

[0024] In certain embodiments, an electrical ablation apparatus may generally include one or more electrodes configured to be positioned in or near unwanted tissue within a tissue treatment area (e.g., a target site or work area). The tissue treatment area may have evidence of abnormal tissue growth. Generally, the electrodes may include a conductive portion and may be configured to be electrically coupled to an energy source. Once the electrodes are positioned in or across the unwanted tissue (e.g., extending beyond bilateral tumors / masses), an energizing potential may be applied to the electrodes to generate an electric field that exposes the unwanted tissue. The energizing potential (and the resulting electric field) may be characterized by various parameters such as frequency, amplitude, pulse width (pulse duration or pulse length), and / or polarity. A suitable energy source includes an electrical waveform generator, such as an IRE, high-frequency IRE, nanopulse, and / or a waveform generator capable of generating an excision waveform. The energy source generates an electric field with desired characteristics for the treatment performed at the target site, based on, for example, the treatment site, application, apparatus, etc. For example, the electric field can be generated to have a suitable characteristic waveform output with respect to voltage, impedance, frequency, amplitude, pulse width, delay (e.g., delay between pulses), number of pulses per burst, number of bursts, and waveform polarity (monopolar or bipolar). Current flows between electrodes and within tissue based on the applied potential and tissue impedance. The supply current provided by the energy source can deliver a pulse sequence to the target site. For example, the energy source can supply various waveforms in one or more pulse sequences tailored to the desired application.

[0025] In some embodiments, the apparatus, assemblies, systems, and methods of the present disclosure are configured for use in treatment / therapy by electroporation and / or irreversible electroporation ("IRE"). For example, the apparatus, assemblies, systems, and methods may be configured according to various principles of the present disclosure for minimally invasive ablation treatment of unwanted tissue through the use of IRE. Minimally invasive ablation treatment may be characterized by its ability to ablate selected tissue in a controlled and intensive manner with reduced or no thermal damage to surrounding healthy tissue.

[0026] According to various principles of this disclosure, an energy delivery treatment system capable of performing electroporation and / or IRE includes a conductive elongated body, which is defined along it as a first electrode portion and a second electrode portion, for example, to form a bipolar probe. Specifically, the electrode portions of the conductive elongated body may be formed from conductive materials such as medical-grade stainless steel, platinum, gold, nitinol, cobalt-chromium alloy, nickel-cobalt alloy such as MP35N, or other alloys, or materials plated with conductive materials. An insulating member is placed between these electrodes to electrically isolate them (typically, one electrode functions as the anode and the other as the cathode). In order to effectively treat a target site using electroporation and / or IRE, it is necessary to generate an effective electric field between the two electrodes of the bipolar probe. However, when energy is applied using a bipolar probe, an arc discharge of energy may occur between the electrodes of the probe. In particular, the risk of arc discharge increases as the electrodes are closer to each other, and / or as the voltage between the electrodes of the probe is higher, and / or as the current applied to the probe is higher. Typically, the smaller the target site for treatment (e.g., the smaller the tumor treated / removed / affected by electroporation and / or IRE energy), the higher the likelihood of arc discharge between electrodes.

[0027] According to various principles of this disclosure, multi-electrode energy delivery assemblies, such as bipolar probes, are configured to reduce arc discharge between their electrodes. Specifically, various features between the electrodes of a multi-electrode energy delivery assembly formed according to various principles of this disclosure are configured to reduce the possibility of arc discharge, thereby increasing the effectiveness and efficiency of the assembly. In some embodiments, the multi-electrode energy delivery assembly is a bipolar probe. In some embodiments, the bipolar probe is a linear bipolar probe comprising a first electrode separated from a second electrode by an insulating member. According to various principles of this disclosure, one or more interfaces between the electrodes of the energy delivery assembly, for example, one or more interfaces between an electrode and an adjacent insulating member, are modified to reduce, if not eliminate, the possibility of arc discharge. This modification may include one or more of the following: In other words, this modification may include one or more of the following: 1) changing the characteristics of one or both electrodes, such as the echogenicity characteristics, and / or changing the size, shape, configuration, properties (e.g., conductivity), and / or dimensions of one or both electrodes; 2) changing the size, shape, configuration, properties (e.g., conductivity), and / or dimensions (e.g., thickness), of the insulating members that define and / or separate the multiple electrodes; and 3) adding material between the multiple electrodes and the insulating members that define and / or separate those multiple electrodes, and / or adding material to cover one or more electrodes. For convenience, and without intent to limit, interfaces modified in accordance with the various principles of this disclosure to reduce arc discharge may generally be referred to as arc-reducing interfaces in this disclosure.

[0028] Energy delivery assemblies may be deliverable transcutaneously / percutaneously through elongated tubular members (e.g., delivery sheaths, catheters, endoscopic working channels, etc.) inserted into the patient (e.g., into body lumens inside the patient through natural anatomical passages or openings). The energy delivery members of an energy delivery assembly may be coupled to an energy source to energize the electrode portions of the energy delivery members and apply an electric current to biological tissue. The energy source may be operable to generate an electric field between the electrode portions and other electrode portions (e.g., electrode portions coupled to the energy source and having opposite polarity (e.g., return or ground)). When an energy delivery assembly formed according to various principles of this disclosure is placed at or near an undesirable tissue site, an electric field may be generated that exposes the tissue at the target site by applying an energizing potential to those electrode portions. The energizing potential (and the resulting electric field) may be characterized by various parameters such as frequency, amplitude, pulse width (pulse duration or pulse length), etc. A suitable energy source includes an electrical waveform generator. The energy source generates an electric field with desired properties for treatment performed at the target site. For example, the electric field may be generated to have a characteristic waveform output with appropriate frequency, amplitude, pulse width, and polarity. The current flows between electrodes and within the tissue in proportion to the potential (e.g., voltage) applied to the electrodes. The supply current provided by the energy source can deliver a pulse sequence to the target site. For example, the energy source may supply various waveforms in one or more pulse sequences tailored to the desired application.

[0029] The energy delivery assemblies, apparatus, systems, and methods described herein can be used in electropermeabilization, irreversible electropermeabilization (IRE), and / or electropermeabilization methods to significantly increase the permeability of the cell membrane by applying an external electric field (potential) to the cell membrane, for example, to improve the uptake of therapeutic substances by the cell. If necessary, the energy applied to the cell can induce cell death (e.g., by apoptosis and / or necrosis) by irreversibly altering the properties of the cell membrane (e.g., porosity). Such methods can be used to treat / apply therapy without raising the temperature of the surrounding tissue to a level that could cause permanent damage to the surrounding tissue, supporting structures, and / or local vascular system. Therefore, the application of IRE pulses to cells can be an effective method for excising large amounts of undesirable tissue without or with minimal harmful thermal effects on surrounding healthy tissue.

[0030] Hereinafter, various embodiments of electrode devices, assemblies, systems, and various related methods will be described with reference to examples shown in the accompanying drawings. References in this specification such as “one embodiment,” “a certain embodiment,” “several embodiments,” and “other embodiments” indicate that one or more specific features, structures, concepts, and / or characteristics according to the principles of this disclosure may be included in relation to that embodiment. However, such references do not necessarily mean that all embodiments include a particular feature, structure, concept, and / or characteristic, or that one embodiment includes all of those features, structures, concepts, and / or characteristics. Some embodiments may include one or more such features, structures, concepts, and / or characteristics in various combinations. It can be understood that one or more of the features, structures, concepts, and / or characteristics described with reference to one embodiment can be combined with one or more of the features, structures, concepts, and / or characteristics of any of the other embodiments provided in this disclosure. That is, any of the features, structures, concepts, and / or characteristics described herein can be mixed and adapted to create hybrid embodiments. Such hybrid embodiments are also included within the scope of this disclosure. Furthermore, references to “one embodiment,” “a certain embodiment,” “several embodiments,” and “other embodiments” in various parts of this specification do not necessarily all refer to the same embodiment, and distinct or alternative embodiments do not necessarily exclude other embodiments from each other. Moreover, the various features, structures, concepts, and / or characteristics of the disclosed embodiments are independent and distinct from one another and may be used individually or in various combinations to create alternative embodiments that are considered part of this disclosure. Therefore, because it would be extremely cumbersome to describe all of the numerous possible and partial combinations of features, structures, concepts, and / or characteristics, this disclosure is not limited to the embodiments specifically described herein, and the examples of embodiments disclosed herein are not intended to limit broader aspects of this disclosure.The various dimensions provided herein are examples only, and those skilled in the art will readily be able to determine the standard deviation and appropriate acceptable range of variation therefrom covered by this disclosure and any associated claims. The following description is merely illustrative of embodiments and is not intended to limit broader aspects of this disclosure.

[0031] In the drawings, common features are identified by common reference elements. For simplicity and convenience, descriptions of common features are generally not repeated, without the intention of limitation. Also, for clarity, not all components with the same reference number are numbered. In the following description, similar elements or components among the various illustrated embodiments are generally designated by the same reference number incremented in multiples of 100, and redundant descriptions are generally omitted for simplicity. Furthermore, certain features in one embodiment may be used across different embodiments, but they are not necessarily individually labeled when described in different embodiments.

[0032] Referring to the drawings, Figure 1 shows an example of an embodiment of the energy delivery treatment system 100. The energy delivery treatment system 100 includes an energy delivery assembly 110 extending along the distal end 100d of the energy delivery treatment system 100. The energy delivery assembly 110 includes an energy delivery member 112 formed of a conductive material such as medical-grade stainless steel, platinum, gold, nitinol, cobalt-chromium alloy, nickel-cobalt alloy such as MP35N, or other alloys, or a material plated with a conductive material. An insulating member 114 is positioned around the proximal portion of the energy delivery member. The insulating member 114 is positioned around the proximal portion of the energy delivery member, for example, to limit energy delivery of the energy delivery member 112 to the energy delivery distal region 116, and / or to prevent energy delivery to the patient along the insulating portion of the energy delivery member 112 on the proximal side of the energy delivery distal region 116. As can be understood by referring to Figure 2, the energy delivery distal region 116 of the energy delivery member 112 is a region that extends proximal from the distal tip or distal end 112d (e.g., free end / terminus) of the energy delivery member 112 to the distal end 114d of the insulating member 114, to define the electrodes 120, 130 of the energy delivery assembly 110 along the energy delivery member 112, as will be described in more detail below. In some embodiments, the distal end 112d of the energy delivery member 112 terminates with a sharp distal tip 118. The sharp distal tip 118 may be configured to puncture tissue / organ / tumor mass (e.g., percutaneously) in a manner known to those skilled in the art. For example, the energy delivery member 112 may be in the form of a trocar. However, this disclosure does not need to be limited to a specific configuration, and more generally, it does not need to be limited in this respect.

[0033] As can be understood by referring to Figure 2, the energy delivery treatment system 100 optionally includes a sheath 102. The energy delivery assembly 110 may be deliverable to a target site using a sharp distal tip 118 within the sheath 102. Thus, the sheath 102 protects the passage through which the energy delivery assembly 110 extends (e.g., an endoscope working channel, a body lumen, etc.) from the sharp distal tip 118 of the energy delivery member 112. The sheath 102 can be selectively retracted proximal to the energy delivery member 112, and / or the energy delivery member 112 can extend distally to the sheath 102, so that at least a distal region 116 of the energy delivery assembly 110 is exposed to the target site when the energy delivery assembly 110 is being used for therapeutic / treatment purposes.

[0034] Optionally, a power supply is coupled to the proximal end 100p of the energy delivery treatment system 100. The energy delivery treatment system 100 may include a power connector 104, such as wiring, which is configured to be coupled to an energy source known to those skilled in the art and is selectable by known means based on the type of energy applied by the energy delivery treatment system 100. For example, the energy source may be selected in a manner known to those skilled in the art to apply energy of a certain nature and to supply energy to an energy delivery assembly 110 used in electroporation and / or IRE. This disclosure is not limited to the details of the energy source.

[0035] The energy delivery treatment system 100 optionally includes a handle 106 operably coupled to the energy delivery assembly 110 for controlling, for example, elements of the energy delivery assembly 110. For example, the handle 106 may be configured to control the relative position of the sheath 102 and / or to control and / or adjust the position of the energy delivery assembly 110 (e.g., its energy delivery member 112). In some embodiments, the energy delivery assembly 110 is delivered to a target site in the patient through a delivery device such as a sheath or endoscope having a lumen or working channel sized to allow passage of the energy delivery assembly 110 and any sheath 102. Such a delivery device may be selected from a variety of delivery devices known to those skilled in the art, but this disclosure is not limited thereto. In some embodiments, the handle 106 may be configured to control and / or adjust the position of the sheath 102 and / or the energy delivery assembly 110 relative to such a delivery device.

[0036] According to various principles of this disclosure, the energy delivery assembly 110 is an elongated, flexible assembly that can be navigated through the patient's body, for example, through natural orifices and / or through elongated tubular members inserted into the patient's body. Specifically, the energy delivery member 112 may be elongated and sufficiently flexible so as to be insertable into the body (e.g., transcatheterally) and navigable through potentially meandering pathways within the body, or so as to be at least flexible or rotatable with and within nonlinear natural anatomical structures. Additionally or alternatively, the energy delivery member 112 may have sufficient elasticity so as not to break during navigation. The appropriate length, flexibility, and / or elasticity of the energy delivery member 112 used in accordance with various principles of this disclosure can be readily determined by those skilled in the art, for example, based on the material, size, shape, construction, and / or dimensions of the energy delivery member 112, and this disclosure is not necessarily limited to specific parameters.

[0037] According to various principles of this disclosure, the energy delivery assembly 110 is configured as a bipolar probe and defines a first electrode 120 and a second electrode 130. In some embodiments, the energy delivery assembly 110 can be considered a linear bipolar probe comprising electrodes 120, 130 formed along the same energy delivery member 112 and generally collinear but axially separated from each other. In a linear configuration, the first electrode 120 may be referred to as the distal electrode 120, and the second electrode 130 may be referred to as the proximal electrode. The references to “first,” “second,” “proximal,” and “distal” in this specification are for convenience only and are not intended to limit them to a particular order or position unless explicitly described by a particular procedure, treatment, method, etc., and / or required (such terms are used interchangeably herein without limitation unless specifically indicated).

[0038] In an example of the embodiment of the energy delivery assembly 110 shown in Figure 2, an electrode-defining insulating member 140 is provided along a selected range (e.g., a limited axial range) of the energy delivery member 112, thereby insulating that range of the energy delivery member 112 and preventing energy delivery along that range. In some embodiments, the electrode-defining insulating member is circumferentially positioned around the energy delivery member 112, covering it and preventing energy from being delivered by the energy delivery member 112 through the electrode-defining insulating member 140. In an example of the embodiment of the energy delivery assembly 110 shown in Figure 2, the distal region 116 of the energy delivery member 112 of the energy delivery assembly 110 (distal to the distal end 114d of the insulating member 114) is configured to deliver energy for treatment / therapy, and the electrode-defining insulating member 140 is positioned along a range of the distal region 116 to define a first electrode 120 separated from a second electrode 130. Therefore, the example embodiment of the energy delivery assembly 110 shown in Figure 2 can be considered a bipolar energy delivery assembly 110, which may also be referred to as a bipolar probe. The insulating member 114 extends to cover the proximal portion of the energy delivery member 112 that is proximal to the proximal end 130p of the second proximal electrode 130, thereby insulating the portion of the energy delivery member 112 that extends proximal to the second proximal electrode 130. Therefore, the insulating member 114 can be considered to define the distal energy delivery region 116 of the energy delivery member 112 and / or to limit the delivery of energy to the target site via the distal electrode 120, which is the first electrode, and the proximal electrode 130, which is the second electrode.

[0039] As those skilled in the art will understand, arc discharge is most likely to begin in areas of high electric field density, such as, for example, along the edges of the interface between an electrode and an insulator. Multi-electrode (e.g., bipolar) probes formed according to the various principles of this disclosure have one or more modified structures for the electrodes and / or insulating members configured to reduce / minimize, and preferably eliminate, arc discharge between their electrodes.

[0040] In some embodiments, the bipolar probe includes a feature that increases echogenicity, for example, to improve visibility using an ultrasonic visualization system and / or method. The echogenic feature may include radial grooves (or other features / coatings) configured to increase echogenicity. For example, echogenic grooves may act to concentrate a local electric field (e.g., as an electric field concentration structure or region). In contrast to typical echogenic grooves, in the example embodiment of the energy delivery assembly 210 shown in Figure 2, the echogenic feature is selectively formed along at least one of the electrodes 220, 230, at the position furthest from the other electrode, according to various principles of the present disclosure. For example, in the embodiment of the energy delivery assembly 210 shown in Figure 2, one or more echogenic features 222 are provided along the distal end 220d of the first electrode, the distal electrode 220 (e.g., at a position along the first electrode 220 and furthest from the second electrode 230), and / or one or more echogenic features 232 are provided along the proximal end 230p of the second electrode, the proximal electrode 230 (e.g., at a position along the second electrode 230 and furthest from the first electrode 220). Such arrangements have been found to reduce / minimize the risk of arc formation. While not bound by theory, such arrangements are thought to reduce stress concentration near material transitions in the energy delivery assembly 210, thereby reducing / minimizing / eliminating arc discharge between electrodes 220 and 230. Various features of the example embodiment of the energy delivery assembly 210 shown in Figure 2 may be similar to the features of the example embodiment of the energy delivery assembly 110 shown in Figures 1 and 2, and are indicated by similar reference letters with values ​​differing in multiples of 100, and for brevity and convenience, the above descriptions of similar elements and operations are referred to without limitation.

[0041] Additionally or alternatively, according to various principles of this disclosure, the shape and / or configuration of the electrodes at the interface between a plurality of electrodes and at least an intermediate electrode-defining insulating member between those electrodes may be modified to reduce / minimize / eliminate arc discharge between those electrodes. For example, in some embodiments, the interface between one or both electrodes of a bipolar probe and at least an intermediate electrode-defining insulating member between such electrodes is configured to eliminate sharp corners. While not bound by theory, it is believed that reducing sharp corners reduces energy concentration in the interface / transition region between the electrodes and adjacent insulating members, thereby reducing arc discharge between electrodes.

[0042] In an example of an embodiment of the energy delivery assembly 310 shown in Figure 3, the interface between one or both of the electrodes 320, 330 and the electrode-defining insulating member 340 between them may be chamfered (e.g., beveled, angled, etc.) and / or filleted (e.g., rounded, curved, etc.). For example, the electrode-defining insulating member 340 is typically positioned around a portion of the energy delivery member 312 (e.g., circumferentially covering it) to define separate electrodes 320, 330 along the energy delivery distal region 316 of the energy delivery member 312. In some embodiments, the outer diameter of the electrode-defining insulating member 340 may be larger than the outer diameter of one or both of the electrodes 320, 330, but the reverse relative dimensions (the outer diameter of the electrodes being larger than the outer diameter of the insulating member) or all outer diameters being substantially the same may also be acceptable. According to various principles of this disclosure, one or both of the edges 342, 344 of the electrode-defining insulating member 340, and / or one or both of the proximal end 320p of the first electrode (distal electrode 320) or the distal end 330d of the second electrode (proximal electrode 330) along the interface between the electrode-defining insulating member 340 and the electrodes 330, 340, are chamfered, rounded, potted, or filleted, respectively. Such a configuration results in a gentler transition between the outer diameter of the electrode-defining insulating member 340 and the outer diameter of one or both of the electrodes 320, 330 than in conventional bipolar probes. Furthermore, the energy delivery member 312 and / or electrode-defining insulating member 340 and / or proximal insulating member 314 forming electrodes 320 and 330 may have similar material properties to the energy delivery member 112, electrode-defining insulating member 140, and / or proximal insulating member 114 described above; therefore, for the sake of simplicity, the above description is referred to without the intention of limitation. Also, various features of the example embodiment of the energy delivery assembly 310 shown in Figure 3 may be similar to the features of the example embodiment of the energy delivery assembly 110 shown in Figures 1 and 2, and are indicated by similar reference letters with values ​​differing in multiples of 200; and for the sake of simplicity and convenience, the above descriptions of similar elements and operations are referred to without the intention of limitation.

[0043] In the example embodiment of the bipolar energy delivery assembly 410 shown in Figure 4, the bipolar energy delivery assembly 410 is formed similarly to the energy delivery assembly described above, and the electrode defining insulating member 440 is positioned between the first electrode 420 and the second electrode 430, thereby defining the first electrode 420 separated from the second electrode 430. Thus, various features of the example embodiment of the energy delivery assembly 410 shown in Figure 4 may be similar to the features of the example embodiment of the energy delivery assembly 110 shown in Figures 1 and 2, indicated by similar reference letters with values ​​differing in multiples of 300, and for brevity and convenience, the above descriptions of similar elements and operations are referred to without intent to limit. In the example of the embodiment of the energy delivery assembly 410 shown in Figure 4, arc discharge between electrodes 420, 430 (shown in cross-section to facilitate understanding of the example of that embodiment) is reduced by providing / forming rolled tube walls 422, 432 at the interface between one or both electrodes 420, 430 and the electrode-defining insulating member 440 between them. Not bound by theory, the curvature of the conductive material of the energy delivery member 412 forming one or both electrodes 420, 430 along the interface with the electrode-defining insulating member 440 reduces the concentration of energy that could cause arc discharge between electrodes 420, 430. Not bound by theory, even if there is generally a sharp material transition between the electrode-defining insulating member 440 and one or both electrodes 420, 430, it is still considered beneficial to reduce arc discharge at such interfaces by eliminating right-angle corners at the insulating interface.

[0044] In addition to, or instead of, modifying the various configurations and / or properties of the conductive region of the bipolar probe to reduce arc discharge between electrodes, various modifications may be made to the insulating members in accordance with the various principles of this disclosure. As can be understood, one or more insulating members may be considered to define the electrodes of an energy delivery assembly by covering a portion of the conductive energy delivery member so as to limit energy delivery to selected areas that are left exposed (uncovered) by the insulating member. According to the various principles of this disclosure, various modifications may also be made to the configuration and / or material of the insulating members of the energy delivery assembly to reduce arc discharge.

[0045] In an example of an embodiment of the energy delivery assembly 510 shown in Figure 5, the proximal insulating member 514 and the electrode defining insulating member 540 are provided covering the conductive energy delivery member 512 to define the first electrode 520 and the second electrode 530, similar to those described with respect to the example of an embodiment of the energy delivery assembly 110 shown in Figures 1 and 2. However, as will be described in more detail below, the electrode defining insulating member 540 is modified to reduce / minimize / eliminate arc discharge between electrodes 520 and 530. Generally, similar to the energy delivery assembly 110 shown in Figure 2, electrodes 520 and 530 are defined along the energy delivery distal region 516 of the energy delivery member 512, which is defined by the distal portion of the conductive energy delivery member 512, which remains uncovered by the insulating member 514 covering the proximal portion of the energy delivery member 512. The additional insulating member 540 is positioned to cover the intermediate region of the energy delivery distal region 516, thereby defining the electrodes 520, 530 of the bipolar energy delivery assembly 510. Various features of the example embodiment of the energy delivery assembly 510 shown in Figure 5 may be analogous to the features of the example embodiment of the energy delivery assembly 110 shown in Figures 1 and 2, indicated by similar reference letters with values ​​differing in multiples of 400, and for brevity and convenience, the above description of similar elements and operations is referenced without intent to limit.

[0046] According to various principles of this disclosure, the electrode-defining insulating member 540 in the example embodiment of the energy delivery assembly 510 shown in Figure 5 is modified to have a more gradual transition of the electrode-defining insulating member 540 to the underlying energy delivery member 512 compared to the electrode-defining insulating member 140 in the example embodiment of the energy delivery assembly 110 shown in Figure 2. Specifically, as can be understood by referring to the example embodiment shown in Figure 5, the electrode-defining insulating member 540 is positioned to cover (for example, in contact with and circumferentially around) the energy delivery member 512 of the energy delivery assembly 510. The illustrated example embodiment of the electrode-defining insulating member 540 is configured such that the transition from the insulating material of the electrode-defining insulating member 540 to the conductive material of the energy delivery member 512 is geometrically gradual (for example, without abrupt transitions that could cause arc discharge). For example, the electrode-defining insulating member 540 may begin as a very thin initial insulating layer at one or both of its distal end 540d and proximal end 540p, and as can be understood by those skilled in the art, the thickness may gradually increase toward the central region of the electrode-defining insulating member 540 in the tapered portion of the edge of the insulating member 540 and other members. Partial conductivity based on the underlying energy delivery member 512 may occur through the thin edges of the insulating member 540 and gradually decrease with increasing thickness and resistance of the insulating member 540. While not bound by theory, it is conceivable that the gradual increase in thickness of the electrode-defining insulating member 540 over the underlying energy delivery member 512 could slow the transition between conductor and insulator, thereby helping to reduce / minimize / eliminate arc discharge between electrodes 520, 530 separated by the electrode-defining insulating member 540. It can also be understood that such a tapered portion may present a non-traumatic surface during the delivery and insertion of the energy delivery assembly 510 into the tissue.

[0047] Referring to Figure 6, another embodiment is shown that modifies the properties and / or features of the electrode-defining insulating member of an energy delivery assembly formed according to various principles of this disclosure. Similar to the example embodiment of the energy delivery assembly 110 shown in Figures 1 and 2, the example embodiment of the energy delivery assembly 610 shown in Figure 6 has an electrode-defining insulating member 640 provided to cover the distal region of the conductive energy delivery member 612, with a first electrode 620 defined on one side of the electrode-defining insulating member 640 and a second electrode 630 defined on the other side of the electrode-defining insulating member 640. Various features of the example embodiment of the energy delivery assembly 610 shown in Figure 6 may be similar to the features of the example embodiment of the energy delivery assembly 110 shown in Figures 1 and 2, and are indicated by similar reference letters with values ​​differing in multiples of 500, and for brevity and convenience, the above description of similar elements and operations is referred to without intent to limit.

[0048] The electrode-defining insulating member 640 in the example embodiment of the energy delivery assembly 640 shown in Figure 6 is configured to define a gentler transition between the conductive electrodes 620 and 630 on either side of the electrode-defining insulating member 640, in contrast to the electrode-defining insulating member 140 in the example embodiment of the energy delivery assembly 110 shown in Figure 1. Specifically, the electrode-defining insulating member 640, which is provided to cover the conductive energy delivery member 612 of the energy delivery assembly 610, is discontinuous along one or both of its distal end 640d (adjacent to the distal electrode 640, which is the first electrode) and proximal end 640p (adjacent to the proximal electrode 640, which is the second electrode). While not bound by theory, such a configuration is thought to disperse electric field concentration along the ends 640d and 640p of the electrode-defining insulating member 640, thereby reducing / minimizing / eliminating arc discharge between electrodes 620 and 630. For example, the slots can diffuse electric field concentration from a single line at the interface between the electrode-defining insulating member 640 and the electrodes 620, 630 to a wider area. In an example of an embodiment of the energy delivery assembly 610 shown in Figure 6, arc discharge between electrodes 620, 630 is reduced / minimized / eliminated by selectively including slots in the electrode-defining insulating member 640 to define a discontinuous region. For example, the ends 640d, 640p of the electrode-defining insulating member 640 may be a coating / cover (e.g., masking) covering the electrodes 620, 630, but may also be integrated into the design of the electrodes themselves (i.e., a hypotube with a laser-cut pattern). The discontinuous pattern / configuration along the electrode-defining insulating member 640 may not be of an elongated hole shape (e.g., circular, curved, oval, etc.), and this disclosure is not limited thereto.

[0049] According to various principles of this disclosure, further or alternative approaches to reducing arc discharge between electrodes can be achieved by doping selected regions of electrode-defining insulating material that define and separate electrodes along the energy-delivering members of an energy-delivering assembly. This doping may result in a gradient to increase the overall conductivity (but not approach the conductivity of the tissue) by increasing the conductivity of the insulating material or the entire electrode-defining insulating material near the interface end adjacent to the electrodes (or decreasing the conductivity of the electrodes). For example, in the embodiment of the energy-delivering assembly 710 shown in Figure 7, the doped electrode-defining insulating material 740 is positioned to cover a portion of the distal region of the energy-delivering member 712, thereby defining the electrodes 720, 730 of the energy-delivering distal region 716 of the energy-delivering assembly 710. The doping of the electrode-defining insulating member 740 shown in Figure 7 may be carried out progressively (for example, with a gradient that gradually increases in the direction toward the distal end 740d and / or the proximal end 740p of the first electrode, the distal electrode 720, and / or along the proximal end 740p of the second electrode, the proximal electrode 730) so that the electrode-defining insulating member 740 has some electrical conductivity. Alternatively, in the example of the embodiment of the energy delivery assembly 810 shown in Figure 8, the electrode-defining insulating member 840 separating the electrodes 820 and 830 in the energy delivery distal region 816 of the energy delivery assembly 810 may be doped substantially uniformly along its entire length to have slight conductivity in order to reduce abrupt changes in electrical conductivity between the electrodes 820 and 830. While not strictly theoretical, a transition zone that smooths the electrical conductivity between the electrodes of a bipolar probe and the insulator between them can be achieved by masking, coating, covering, etc., and by altering the conductivity across the transition region, arc discharge in such a transition region can be reduced (compared to conventional bipolar probes). Alternatively or additionally, energy may correlate with current density / concentration.Various features of the example embodiments of the energy delivery assemblies 710 and 810 shown in Figures 7 and 8 may be similar to the features of the example embodiment of the energy delivery assembly 110 shown in Figures 1 and 2, and are indicated by similar reference letters with different values ​​in multiples of 600 (for energy delivery assembly 810) or multiples of 700 (for energy delivery assembly 810), and for brevity and convenience, the above descriptions of similar elements and operations are referred to without limitation.

[0050] In addition to, or instead of, modifying the electrodes and / or insulating materials of a bipolar probe to reduce arc discharge, various materials for reducing arc discharge may be added to bipolar energy delivery assemblies formed according to various principles of this disclosure. Specifically, according to various principles of this disclosure, a third material (and possibly more) acting as a buffer / matching layer may be added to the transition between materials of different electrical conductivity, thereby reducing the difference in electrical conductivity at the transition between them. While not bound by theory, it is generally believed that a more gradual change in conductivity reduces the likelihood of arc discharge between separated electrodes and / or conductive materials.

[0051] For example, in the example of an embodiment of the bipolar energy delivery assembly 910 shown in Figure 9, the additional transition member 950 may be provided covering the conductive energy delivery member 912 of the energy delivery assembly 910 so as to be adjacent to one side (one end) or both sides (both ends) of the electrode defining insulating member 940 that defines and separates the electrodes 930, 940 of the bipolar energy delivery assembly 910. Specifically, similar to the example of an embodiment of the energy delivery assembly 110 described above with reference to Figure 2, the example of an embodiment of the energy delivery assembly 910 shown in Figure 9 includes a conductive energy delivery member 912 with an insulating member 914 positioned around the proximal portion 910p to define the energy delivery distal region 916 of the energy delivery assembly 910, and at least a portion of the conductive energy delivery member 912 is exposed along the energy delivery distal region 916 to define the electrodes 920, 930 of the energy delivery assembly 910. The electrode-defining insulating member 940 is positioned to cover the energy delivery member 912 along the intermediate portion of the energy delivery distal region 916 (between the distal end 912d of the energy delivery member 912 and the distal end 914d of the insulating member 914), thereby defining a first electrode 920 separated from the second electrode 930 by dividing multiple regions or parts of the energy delivery member 912 (for example, dividing multiple conductive regions or parts). In the illustrated embodiment, according to various principles of the present disclosure, a distal transition member 950d is provided between the first electrode, the distal electrode 920, and the distal end 940d of the electrode-defining insulating member 940, and / or a second transition member 950p is provided between the second electrode, the proximal electrode 930, and the proximal end 940p of the electrode-defining insulating member 940. Various other features of the example embodiment of the energy delivery assembly 910 shown in Figure 9 may be similar to the features of the example embodiment of the energy delivery assembly 110 shown in Figures 1 and 2, and are indicated by similar reference letters with values ​​differing in multiples of 800, and for brevity and convenience, the above descriptions of similar elements and operations are referred to without intent to limit.

[0052] According to various principles of this disclosure, one or more transition members 950 are positioned along the energy delivery member 912 in an example embodiment of the energy delivery assembly 910 shown in Figure 9 (e.g., on and around it circumferentially to cover it) between a plurality of conductive portions of the energy delivery member 912 (electrodes 920, 930) and the electrode-defining insulating member 940 between them. One or more transition members 950 are configured as matching layers / members and / or buffers of conductive material between a plurality of conductive regions (e.g., electrodes 920, 930) of the energy delivery distal region 916 of the energy delivery assembly 910 and the electrode-defining insulating member 940. For example, the transition member 950 may have a conductivity lower than that of the electrodes 920, 930 to reduce the conductivity difference between the conductive electrodes 920, 930 and the electrode-defining insulating member 940 between them. The transition member 950 may include, but is not limited to, additional different materials, material treatments, and / or other transition regions between the insulating member and the plurality of electrodes it separates. The transition member 950 is selected to reduce arc discharge between electrodes 920 and 930 of the energy delivery assembly 910 by having an intermediate conductivity (i.e., being non-insulating or non-non-conductive) that is lower than the conductivity of the adjacent electrodes 920 and 930 and higher than that of the electrode-defining insulating member 940. The material of the transition member 950 may be a conductive, preferably biocompatible material having a conductivity lower than that of the energy delivery member 912 (e.g., bulk metallic glass, metals such as nickel, chromium, tungsten, and iron, or alloys such as nitinol, nichrome, and titanium), a low-strength, dielectric, preferably biocompatible material having a conductivity lower than that of the energy delivery member 912 (silicone, polypropylene, polyethylene, polycarbonate, polyether block amide, thermoplastic urethane (TPU), urethane, or stretched PTFE (ePTFE)), or any material having a conductivity level between that of the electrode-defining insulating member 940 and that of one or both of electrodes 920 and 930.Additionally or alternatively, a portion of the energy delivery member 912 closest to the electrode-defining insulating member 940 that defines electrodes 920, 930 along the energy delivery member 912 (for example, a portion of one of electrodes 920, 930 that is closer to the other electrode) may be treated (deposition, hardening, etc.) to reduce its electrical conductivity within that portion. Such a portion may extend along the entire region of the energy delivery member 912 where a separate transition member 950 may be located, in which case it is not shown separately.

[0053] In addition to, or instead of, one or more of the above-described features, components, treatments, etc., for reducing arc discharge between electrodes of a bipolar probe according to the various principles of this disclosure, the electrical conductivity in such regions may be reduced by providing additional material over regions of the conductive material forming at least one electrode of the probe. For example, in addition to, or instead of, modifying the base material as described above, the arc discharge between electrodes may be reduced / minimized / eliminated by modifying the surface properties of the energy delivery members of an energy delivery assembly formed according to the various principles of this disclosure. Layers, coatings, etc., can be referred to interchangeably without limitation herein. Coatings may be formed from materials with lower conductivity than the material of the energy delivery member to which the coating is applied. Examples of materials acceptable for such coatings include, but are not limited to, oxides, ceramics, silicones, polypropylene, polyethylene, polycarbonates, polyether block amides, TPUs, urethanes, ePTFEs, and patterned, preferably biocompatible materials.

[0054] The coating or layer may be provided in various ways to reduce / minimize / eliminate arc discharge according to various principles of this disclosure. For example, in the example of the embodiment of the energy delivery assembly 1000 shown in Figure 10, an oxide layer (e.g., by the application of thermal, chemical, atmospheric conditions, and / or a combination thereof) that can be applied to cover the energy delivery member 1012 of the energy delivery assembly 1010 may be modified to reduce / minimize / eliminate arc discharge between the electrodes 1020 and 1030 of the energy delivery assembly 1010. Specifically, similar to the example of the embodiment of the energy delivery assembly described above, the energy delivery distal region 1016 of the energy delivery assembly 1010 may be defined along the distal region of the conductive energy delivery member 1012, which is distal to the insulating member 1014 covering the proximal portion of the energy delivery member 1012. The electrode defining insulating member 1040 may be provided along the intermediate region of the energy delivery distal region 1016 to define and separate the electrodes 1020 and 1030 along the energy delivery distal region 1016. Various other features of the example embodiment of the energy delivery assembly 1010 shown in Figure 10 may be similar to the features of the example embodiment of the energy delivery assembly 110 shown in Figures 1 and 2, and are indicated by similar reference letters with values ​​differing in multiples of 900, and for brevity and convenience, the above descriptions of similar elements and operations are referred to without intent to limit. According to various principles of this disclosure, the oxide layer covering electrodes 1020, 1030 is increased in thickness (compared to a typical oxide layer) by passivation, anodizing, etc., of the conductive energy delivery member 1012. Such an increase in thickness is present in regions closer to the electrode-defining insulating member 1040 (e.g., the distal end 1040d and / or proximal end 1040p of the insulating member 1040 adjacent to electrodes 1020 and / or electrodes 1030). While not limited to theory, a thicker oxide film can result in a gradual transfer of conductivity from one or both of electrodes 1020 and 1030 to the non-conductive electrode-defining insulating member 1040 between those electrodes 1020 and 1030.

[0055] Additionally or alternatively, at least a portion of the electrodes of a bipolar energy delivery assembly formed according to various principles of this disclosure may be coated with a low-conductivity material or a non-conductive coating. For example, electrodes 1120, 1130 in an example embodiment of the energy delivery assembly 1110 shown in Figure 11 may be coated with a low-conductivity material or a non-conductive coating at least adjacent to an electrode-defining insulating member 1140 that defines and separates electrodes 1120, 1130 along an energy delivery member 1112 that defines the energy delivery portion of the energy delivery assembly 1110. Various features of the example embodiment of the energy delivery assembly 1110 shown in Figure 11 may be analogous to features of the example embodiment of the energy delivery assembly 110 shown in Figures 1 and 2, indicated by similar reference letters with values ​​differing in multiples of 1000, and for brevity and convenience, the above description of similar elements and operations is referenced without intent to limit. According to various principles of this disclosure, a low-conductivity region is defined along at least one of the electrodes 1120, 1130 by applying a coating 1150 so as to cover at least a portion of at least one of the electrodes 1120, 1130, such as an electrode adjacent to the electrode-defining insulating member 1140. The coating may be formed from a material different from the material of the energy delivery member 1112, such as bulk metallic glass, ceramic, polymer, or doped polymer. Although not limited to theory, such a coating can cause a stepwise transition of electrical conductivity from one or both of the electrodes 1120, 1130 to the non-conductive electrode-defining insulating member 1140 between those electrodes 1120, 1130.

[0056] In some embodiments, the oxide layers and / or applied coatings described above, with reference to examples of embodiments of energy delivery assemblies 1010, 1110 shown in Figures 10 and 11, respectively, may be patterned (e.g., to have discontinuities) using masking and / or other application methods known to those skilled in the art. This pattern may be selected to manipulate the electric field between the electrodes of the energy delivery assembly to reduce arc discharge between them. For example, in an example of an embodiment of the energy delivery assembly 1210 shown in Figure 12, the coating 1250 covering the energy delivery member 1212 of the energy delivery assembly 1210 may include a distal coating 1250d between the first electrode, the distal electrode 1320, and the electrode defining insulating member 1240, and / or a proximal coating 1250p between the second electrode, the proximal electrode 1230, and the electrode defining insulating member 1340. Various features of the example embodiment of the energy delivery assembly 1210 shown in Figure 12 may be similar to the features of the example embodiment of the energy delivery assembly 110 shown in Figures 1 and 2, and are indicated by similar reference letters with different values ​​in multiples of 1100, and for brevity and convenience, the above description of similar elements and operations is referred to without intent to limit. In the example embodiment of the patterned coatings 1250d, 1250p shown in Figure 12, the pattern may include axial gaps between coatings such as the illustrated distal coating 1250d (e.g., axial gaps between circumferentially extending coatings that are axially separated from each other), and / or circumferential gaps along the coating such as the illustrated proximal coating 1250p. These gaps do not have to be linear and may instead have other shapes, patterns, or topography (e.g., arcuate or other shapes). While not limited to theory, a pattern with defined gaps within a coating that covers the conductive energy delivery member 1212 of the energy delivery assembly 1210, as shown in Figure 12, can cause a stepwise transition of electrical conductivity from one or both of the electrodes 1220 and 1230 to the non-conductive electrode defining insulating member 1240 between those electrodes 1220 and 1230.

[0057] Any of the bipolar probes described above may be configured as linear probes with multiple electrodes spaced axially apart from one another. However, it can be understood that non-linear configurations are also included within the scope and concept of this disclosure. Furthermore, although the examples of embodiments described above are shown having only two electrodes, the principles described above can also be applied to other bipolar, unipolar, and / or monopolar devices, etc., and to energy delivery assemblies having three or more electrodes. The principles of this disclosure can also be applied to energies other than electroporation and / or IRE energy, such as other energy sources for ablation or other purposes. Finally, although not explicitly described, it can be understood that the distal end of any of the energy delivery members described above may be terminated with a sharp distal tip (for example, the energy delivery member may be in the form of a trocar), or may have another configuration as needed or as specified by the procedure performed using the energy delivery assembly (for example, non-traumatic such as blunt or flexible, or a lumen device, etc.) (for example, it may be a needle with an internal lumen). It should be understood that the devices, systems, assemblies, and methods disclosed herein may be delivered endoscopically, transluminally, or percutaneously, and may be used within other access devices, such as other maneuverable lumen access devices.

[0058] It should be understood that all structures, devices, systems, assemblies, and methods described herein are examples of implementations in accordance with one or more principles of the Disclosure, and are not the only ways of implementing these principles, and are therefore not intended to limit the broader aspects of the Disclosure. Accordingly, references to elements, structures, or features in the drawings should be recognized as references to examples of embodiments of the Disclosure and should not be understood as limiting the Disclosure to any specific element, structure, or feature illustrated. By reading this Disclosure, a person skilled in the art will be able to conceive of other examples of ways of implementing the disclosed principles. It will be apparent to a person skilled in the art that modifications to the sequence of steps of the disclosed devices, assemblies, systems, methods, and / or methods described herein can be applied without departing from the concepts, ideas, and scope of the Disclosure. It should be understood that various features described in relation to one embodiment can typically be applied to other embodiments, whether expressly shown or not. Various features can be used individually or in any combination thereof. Accordingly, the present invention is not limited to the embodiments specifically described herein, and all substitutions and modifications that are obvious to those skilled in the art are deemed to be included within the spirit, scope, and concept of this disclosure as defined by the appended claims.

[0059] The above description is for broad purposes only, is presented for illustrative and explanatory purposes, and is not intended to limit the disclosure to the forms disclosed herein. It can be understood that various additions, modifications, and substitutions may be made to the embodiments disclosed herein without departing from the concepts, ideas, and scope of the disclosure. In particular, it will be apparent to those skilled in the art that the principles of the disclosure may be embodied in other forms, structures, arrangements, and proportions, and using other elements, materials, and components, without departing from the concepts, spirit, scope, or features thereof. For example, various features of the disclosure are grouped together in one or more aspects, embodiments, or configurations for the purpose of streamlining the disclosure. However, it can be understood that various features of a particular aspect, embodiment, or configuration of the disclosure may be combined in alternative aspects, embodiments, or configurations. Although the disclosure is presented in terms of embodiments, it can be understood that various individual features of the subject matter do not all need to be present to achieve at least some of the desired properties and / or advantages of the subject matter or such individual features. Those skilled in the art will understand that this disclosure can be used with many variations of structures, arrangements, proportions, materials, components, and other things used in carrying out this disclosure, without departing from the principles, ideas, or scope of this disclosure, to be particularly adapted to specific environmental and operating requirements. For example, an element shown as being formed as a whole may consist of multiple parts, or an element shown as multiple parts may be formed as a whole, the operation of an element may be reversed or otherwise modified, and the size or dimensions of an element may be modified. Similarly, while an operation, action, or procedure is described in a particular order, this should not be understood as requiring such a particular order to achieve a desired result, or as meaning that all operations, actions, or procedures should be performed. Other implementations are also included in the following claims. In some cases, the actions described in the claims may be performed in a different order and still achieve the desired result.Accordingly, the embodiments disclosed herein should be considered in all respects as illustrative and not limiting, and the scope of the claimed subject matter is as indicated by the appended claims and is not limited to the above description or any specific embodiment or configuration described or shown herein. In this regard, individual features of any embodiment may be used separately or in combination with features of that embodiment or any other embodiment and may be claimed, and the scope of the subject matter is as indicated by the appended claims and is not limited to the above description.

[0060] In the above description and the following claims, please understand the following: The phrases “at least one,” “one or more,” and “and / or” as used in this disclosure are open-ended expressions that are both conjunctive and disjunctive in operation. Terms such as “one,” “it,” “first,” and “second” do not exclude plurals. For example, the term “one” entity, as used herein, means that there is one or more entities. Thus, the terms “one,” “one or more,” and “at least one” may be used interchangeably herein. The term “or” as used herein and in the claims is used generally to include “and / or” unless otherwise explicitly indicated. The conjunction “and” as used herein includes each of the structures, components, features, etc. that are thus joined, unless the context explicitly indicates otherwise, and the conjunction “or” includes one or more of the structures, components, features, etc. that are thus joined, individually, in any combination and number, unless the context explicitly indicates otherwise. All references to direction (e.g., proximal, distal, upper, lower, upward, downward, left, right, lateral, longitudinal, front, back, top, bottom, up, down, vertical, horizontal, radial, axial, clockwise, counterclockwise, and / or others) are used solely for identification purposes to aid the reader's understanding of this disclosure and / or to distinguish areas of related elements from one another, and do not limit the elements relevant in particular with respect to the position, orientation, or use of this disclosure. References to connections (e.g., attached, joined, connected, engaged, joined, etc.) should be interpreted broadly and, unless otherwise indicated, may include intermediate members between sets of elements and relative movement between elements. Thus, references to connections do not necessarily mean that two elements are directly connected and fixed to each other. Identifying references (e.g., primary, secondary, first, second, third, fourth, etc.) are not intended to imply importance or priority and are used to distinguish one feature from another.

[0061] The following claims are incorporated by reference to this detailed description, and each claim stands independently as a distinct embodiment of the present disclosure. In the claims, the terms “equipped,” “equipped,” “included,” and “included” do not exclude the existence of other elements, components, features, groups, areas, integers, steps, operations, etc. Individual features may be included in different claims, but they may be advantageously combined in some cases, and their inclusion in different claims does not mean that the combination of features is unfeasible and / or unfavorable. Also, a singular reference does not exclude plurals. Reference numerals in the claims are provided merely as examples for clarity and should not be construed as limiting the claims.

Claims

1. An energy delivery assembly, An energy delivery member formed from a conductive material, An electrode defining insulating member is positioned to cover a portion of the energy delivery member and defines a first electrode that is separated from the second electrode, At least one arc reduction interface between the electrode defining insulating member and one adjacent electrode among the first and second electrodes, An energy delivery assembly equipped with [the following features].

2. The energy delivery assembly according to claim 1, wherein the arc reduction interface includes a modified shape in at least one of the electrode defining insulating member and one of the adjacent electrodes of the first and second electrodes.

3. The energy delivery assembly according to claim 2, wherein the arc reduction interface includes a chamfer or fillet along the interface between the electrode defining insulating member and one of the adjacent electrodes among the first and second electrodes.

4. The energy delivery assembly according to claim 2 or 3, wherein the arc reduction interface includes the rolled wall of the first electrode adjacent to the electrode defining insulating member.

5. The energy delivery assembly according to any one of claims 2 to 4, wherein the arc reduction interface is further characterized in that the thickness of the electrode-defining insulating member adjacent to one of the adjacent first and second electrodes is reduced with respect to an intermediate region of the electrode-defining insulating member spaced apart from the adjacent first and second electrodes.

6. The energy delivery assembly according to any one of claims 2 to 5, wherein the arc reduction interface includes a discontinuity in the electrode defining insulating member adjacent to at least one of the adjacent first and second electrodes.

7. The energy delivery assembly according to claim 6, wherein a slot for defining the discontinuity is provided in the electrode defining insulating member.

8. At least one of the first electrode and the second electrode has an end adjacent to the electrode defining insulating member and an end spaced apart from the electrode defining insulating member. The echo-generating feature portion is provided at a position closer to at least one of the first and second electrodes that is spaced further away from the electrode-defining insulating member than to at least one of the first and second electrodes that is adjacent to the electrode-defining insulating member. The energy delivery assembly according to any one of claims 1 to 7, wherein at least one end of the first electrode and the second electrode adjacent to the electrode defining insulating member, the end not having an echo-generating feature, defines the arc reduction interface.

9. The energy delivery assembly according to any one of claims 1 to 8, wherein the arc reduction interface is formed by doping at least a region of the electrode-defining insulating member such that a gradient is created in the electrical conductivity between one of the first and second electrodes and the electrode-defining insulating member.

10. The energy delivery assembly according to any one of claims 1 to 9, wherein the arc reduction interface includes a non-insulating additional member between the electrode defining insulating member and the adjacent one of the first and second electrodes, the non-insulating additional member having an electrical conductivity lower than that of the adjacent one of the first and second electrodes.

11. The energy delivery assembly according to any one of claims 1 to 10, wherein the arc reduction interface includes a coating covering one of the adjacent electrodes of the first and second electrodes.

12. The energy delivery assembly according to any one of claims 1 to 11, wherein the first electrode and the second electrode are on the same line, and the energy delivery assembly is defined as a linear bipolar probe.

13. The energy delivery assembly according to any one of claims 1 to 12, wherein the energy delivery assembly is part of an energy delivery treatment system comprising a power connector configured to deliver energy along the first and second electrodes by delivering energy to the energy delivery assembly and to the energy delivery member.

14. A method for applying electroporation or irreversible electroporation energy using a multi-electrode energy delivery treatment system having at least a first electrode and a second electrode, wherein the first electrode and the second electrode are defined along the energy delivery member by an electrode-defining insulating member arranged to cover the energy delivery member of the multi-electrode energy delivery treatment system, thereby separating the first electrode and the second electrode from each other, and the method is as follows: To deliver energy from an energy source to the energy delivery member of the multi-electrode energy delivery treatment system, thereby delivering electroporation or irreversible electroporation energy to the first electrode and the second electrode of the multi-electrode energy delivery treatment system, and To reduce arc discharge between the first electrode and the second electrode of the multi-electrode energy delivery system by creating a gradient in the electrical conductivity between at least one of the first electrode and the second electrode of the multi-electrode energy delivery system and the electrode-defining insulating member, A method for providing this.

15. The method according to claim 14, wherein generating a gradient in the electrical conductivity includes at least one of the following: changing the characteristics of at least one of the first electrode and the second electrode of the multi-electrode energy delivery treatment system; changing the characteristics of the electrode-defining insulating member; adding a non-insulating member having an intermediate electrical conductivity smaller than the electrical conductivity of at least one of the first electrode and the second electrode between at least one of the first electrode and the second electrode and the electrode-defining insulating member; and coating at least a portion of at least one of the first electrode and the second electrode.

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