Adjustable needle electrodes and related systems and methods for medical procedures

Abstract

A bipolar or unipolar adjustable energy supply assembly. The assembly is configured for transvascular (e.g., endoscopic) delivery within a patient. The first energy supply member defines a first electrode portion formed from a conductive material, so that energy can be supplied to the first energy supply member, generating an energy field along the first electrode portion and applied to a target site within the patient. The first energy supply member may define a lumen through the first energy supply member, allowing for the delivery of a substance distally to a target site through the lumen and / or allowing a substance from the target site to be attracted proximally through the lumen. Optionally, a second energy supply member and a second insulating member form a second electrode portion. Optionally, one or both electrode portions may be adjustable. Additionally or alternatively, the first and second electrode portions are adjustable relative to each other.

Description

Technical Field

[0001] The present disclosure generally relates to the field of medical devices, assemblies, systems, and methods used to apply energy to a patient for therapeutic purposes and the like. More specifically, the present disclosure relates to the field of medical devices, assemblies, systems, and methods for applying electrical energy, such as therapeutic electrical pulses, to a patient. Even more specifically, the present disclosure relates to various devices, assemblies, systems, and methods for electroporation procedures. Still even more specifically, the present disclosure relates to length-adjustable medical treatment devices, assemblies, and systems for applying energy, such as electrical energy for electroporation and the like, and related methods.

Background Art

[0002] Various devices, assemblies, and systems exist for energy-based medical treatments or therapeutic protocols. Currently, bipolar devices (those having two electrodes) can be inserted into a patient either percutaneously or endoscopically. After being placed within a target site (e.g., a tumor), the device is actuated for various therapeutic maneuvers, such as by generating an electric field between and / or around the two electrodes of the device. For example, energy can be applied to perform radio frequency ablation (RFA), electroporation, and / or irreversible electroporation (IRE) as a way to treat various conditions and / or diseases by disrupting and / or changing the properties of biological cell material. The irreversible electroporation energy applied by the device creates pores within the cell membrane in the vicinity of the device. The electric field disrupts homeostasis and kills the cells. Radio frequency ablation causes thermal coagulation of tissue.

[0003] Bipolar electroporation devices generally cause less muscle contraction compared to unipolar devices, which have a single active electrode and a return grounding pad placed on the patient's skin. However, in contrast to unipolar devices, bipolar devices have a lower ablation volume, less arc discharge between electrodes, higher complexity, and may have multiple layers of electrodes and insulation between them to accommodate a small-diameter needle. In contrast to bipolar devices, unipolar devices may be considered inherently simpler, can form a larger ablation volume, reduce the risk of arc discharge, and may have space for other features or structures or devices such as increased insulation thickness. The thicker insulation provided by unipolar devices may consequently enable improved dielectric strength, improved electrical safety, and the ability to be used at higher voltages to obtain a higher ablation volume.

[0004] Length-adjustable electrodes (either monopolar or bipolar) may offer several advantages, including ensuring that the ablation volume is well-fitted to the target site (e.g., tumor volume), ensuring complete ablation of the tumor volume, and helping to avoid ablation of healthy tissue (e.g., pancreatic tissue, GI duct wall, etc.) and / or non-target nearby biological structures such as blood vessels. In light of these and other considerations, this improvement may be useful. [Overview of the Initiative]

[0005] This summary of the invention is provided in a simplified form to introduce a selection of concepts that will be described in more detail in the embodiments for carrying out the invention described below. This summary is not intended to necessarily identify any major 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. Those skilled in the art will understand that each of the various aspects and features of the disclosure may be used advantageously, either separately in some cases or in combination with other aspects and features of the disclosure in other cases, 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 any elements, components, etc., in this summary.

[0006] In accordance with various principles of the present disclosure, an energy supply assembly includes a first energy supply member having a sharp distal tip configured to puncture tissue, and having a lumen defined through the first energy supply member and adjacent to the sharp distal tip, the lumen being for delivering material distally through the lumen and discharging from the distal tip, and / or drawing material into the distal tip of the lumen and drawing it proximal through the lumen; and a first insulating member extending over the first energy supply member and having a distal end. In some embodiments, the first electrode portion of the energy supply assembly is defined along the first energy supply member between the sharp distal tip of the energy supply assembly and the distal end of the first insulating member.

[0007] In some embodiments, the first electrode portion is adjustable by moving the first insulating member relative to the first energy supply member. In some embodiments, the first electrode portion and the first insulating member have substantially the same outer diameter.

[0008] In some embodiments, the energy supply assembly further includes a second energy supply member positioned on a first insulating member and having a distal end, and a second insulating member extending on the second energy supply member and having a distal end. In some embodiments, the second electrode portion of the energy supply assembly is defined along the second energy supply member between the distal end of the second energy supply member and the distal end of the second insulating member. In some embodiments, at least one of the first energy supply member, the first insulating member, the second energy supply member, or the second insulating member is movable relative to another of the first energy supply member, the first insulating member, the second energy supply member, or the second insulating member to adjust at least one of the first electrode portion or the second electrode portion. In some embodiments, the first insulating member is movable relative to the first energy supply member to adjust the first electrode portion. In some embodiments, the second energy supply member is movable relative to the first insulating member. In some embodiments, the second insulating member is movable relative to the second energy supply member. In some embodiments, the second energy supply member is movable relative to the first insulating member. In some embodiments, the second insulating member is movable relative to the second energy supply member. In some embodiments, the first energy supply member and the first insulating member are fixed to each other, and the second energy supply member and the second insulating member are fixed to each other. In some embodiments, the second energy supply member is able to advance distally so that its distal end is moved distal to the distal end of the first energy supply member, thereby covering the sharp distal tip of the first energy supply member. In some embodiments, the first electrode portion and the second electrode portion have substantially the same outer diameter. In some embodiments, the second insulating member is movable relative to the second energy supply member. In some embodiments, a window is formed within the second insulating member for exposing a variable length of the second electrode portion, and the distal end of the second insulating member is movable over the first electrode portion to expose a variable length of the first electrode portion.

[0009] In accordance with various principles of the present disclosure, an energy supply treatment system comprises an energy supply assembly, the energy supply assembly comprising a first energy supply member having a sharp distal tip configured to puncture tissue, a lumen defined through the first energy supply member and having a distal opening adjacent to the sharp distal tip, the lumen being for delivering material distally through the lumen and discharging from the distal opening of the lumen, and / or drawing material into the distal opening of the lumen and drawing material proximal through the lumen; and a first insulating member extending over the first energy supply member and having a distal end. In some embodiments, the first electrode portion of the energy supply assembly is defined along the first energy supply member between the sharp distal tip of the first energy supply member and the distal end of the first insulating member, and the energy supply assembly comprises a handle, the energy supply assembly comprising a handle extending distally from the handle. In some embodiments, the handle is operably connected to a first insulating member and includes a first control portion for adjusting the position of the first insulating member relative to a first energy supply member, and is operably connected to an energy source and configured to supply energy to the first energy supply member.

[0010] In some embodiments, the energy supply treatment system further includes a sheath extending distally from the handle, and a first energy supply member and a first insulating member extending distally from the handle through the sheath, operably connected to the first energy supply member, and a second control unit for adjusting the position of the first energy supply member relative to the sheath.

[0011] In some embodiments, the energy supply system further includes a second energy supply member positioned on a first insulating member and having a distal end, a second insulating member extending on the second energy supply member and having a distal end, and a third control portion operably connected to the second insulating member for adjusting the position of the second insulating member relative to the second energy supply member. In some embodiments, the second electrode portion of the energy supply assembly is defined along the second energy supply member between the distal end of the second energy supply member and the distal end of the second insulating member.

[0012] A method for treating a target site in a human patient, according to various principles of this disclosure, includes the steps of supplying energy to a first energy supply member covered by a first insulating member to define a first electrode portion at the distal end of the first energy supply member, and delivering a substance to the target site through a lumen defined through the first energy supply member. In some embodiments, the substance delivery step includes at least one of delivering the substance distally to the target site through the lumen, or drawing the substance proximal to the target site through the lumen.

[0013] In some embodiments, the method further includes the step of adjusting the length of the first electrode portion. These and other features and advantages of this disclosure will be readily apparent from the following detailed description, and the scope of the claimed invention is set forth in the attached claims. The following disclosure is presented with respect to aspects or embodiments, but it should be understood that each aspect may be claimed separately or in combination with the aspects and features of that embodiment or any other embodiment. [Brief explanation of the drawing]

[0014] Non-limiting embodiments of this disclosure are described by reference to the accompanying drawings, which are schematic and not intended to be drawn to scale. The accompanying drawings are provided for illustrative purposes only, and dimensions, locations, order, and relative sizes reflected in the drawings may vary. For example, devices may be enlarged to allow for the identification of details, but are intended to be reduced to fit within, for example, a delivery catheter or an endoscope's working channel. In the drawings, identical, substantially identical, or equivalent elements are usually indicated by the same reference numeral, similar elements are usually designated by similar reference numerals increasing in increments of 100, and redundant descriptions are omitted. For clarity and brevity, not all elements are labeled in all drawings, and not all elements of each embodiment are shown where illustration is not necessary to enable those skilled in the art to understand this disclosure.

[0015] A more detailed explanation will be better understood in conjunction with the attached drawings, where similar reference numbers represent similar elements, as shown below. [Figure 1] This is a front view of an example of an embodiment of an energy supply treatment system formed according to an aspect of the present disclosure. [Figure 1A] This is a detail diagram along detail area 1A of Figure 1, illustrating further details of an example embodiment of an energy supply assembly formed in accordance with various principles of the present disclosure and usable in an energy supply treatment system such as the one illustrated in Figure 1. [Figure 2] This is a cross-sectional view along line II-II in Figure 1A. [Figure 3] This cross-sectional view is similar to that in Figure 2, but shows another example of an embodiment of the energy supply assembly. [Figure 4A] This is a front view of another example of an embodiment of an energy supply treatment system formed according to an aspect of the present disclosure, arranged in a first configuration corresponding to a first configuration of an energy supply assembly. [Figure 4B]This is a front view of an example of an embodiment of the energy supply treatment system shown in Figure 4A, arranged in a second configuration corresponding to a second configuration of the energy supply assembly. [Figure 5] An example of an embodiment of an adjustable bipolar energy supply assembly formed according to various principles of the present disclosure is shown, with the inner / first / distal energy supply member shown in a front view and the insulating member and the outer / second / proximal energy supply member shown in a cross-sectional view. [Figure 6A] This is a cross-sectional view of an example embodiment of an adjustable bipolar energy supply assembly, showing the first energy supply member in a front view and covered by the second energy supply member shown in the cross-sectional view. [Figure 6B] Figure 6A shows the adjustable bipolar energy supply assembly, with the first energy supply member advanced distally from the second energy supply member and entering the target site. [Figure 6C] Figures 6A and 6B show the adjustable bipolar energy supply assembly with the second energy supply member advanced into the target area. [Figure 7A] This is a front view of an example embodiment of an energy supply treatment system, formed according to various principles of the present disclosure and configured to adjust an example embodiment of the energy supply assembly shown in Figure 6A. [Figure 7B] This is a front view of the energy supply treatment system shown in Figure 7A, in a configuration corresponding to the energy supply assembly configuration shown in Figure 6B. [Figure 7C] This is a front view of the energy supply treatment system shown in Figure 7A, in a configuration corresponding to the energy supply assembly configuration shown in Figure 6C. [Figure 8A] This is a cross-sectional view of an example embodiment of an adjustable bipolar energy supply assembly formed according to various principles of the present disclosure, arranged in a unipolar configuration. [Figure 8B] This figure shows an adjustable bipolar energy supply assembly, as illustrated in Figure 8A, arranged in a bipolar configuration. [Figure 9A] A cross-sectional view of an example of an embodiment of an adjustable bipolar energy supply assembly formed in accordance with various principles of the present disclosure, where the proximal energy supply member is in a first configuration. [Figure 9B] The adjustable bipolar energy supply assembly of FIG. 9A is shown, where the proximal energy supply member is in a second configuration. [Figure 10A] A cross-sectional view of an example of an embodiment of an adjustable bipolar energy supply assembly formed in accordance with various principles of the present disclosure, where the energy supply member is in a first configuration. [Figure 10B] The bipolar adjustable energy supply assembly of FIG. 10A is shown, where the energy supply member is in a second configuration. [Figure 10C] A front view of the bipolar adjustable energy supply assembly of FIG. 10A. [Figure 10D] A front view of the bipolar adjustable energy supply assembly of FIG. 10C.

Mode for Carrying Out the Invention

[0016] The following detailed description should be read with reference to the drawings illustrating exemplary embodiments. It should be understood that this disclosure is not limited to the specific embodiments described and is therefore subject to change. 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 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 specific elements, structures, or features illustrated. Other examples of ways of implementing the disclosed principles will be recalled by those skilled in the art who have read this disclosure. Indeed, it will be apparent to those skilled in the art that various modifications and variations can be made in this disclosure without departing from the scope of the subject matter or the technical idea. For example, a feature illustrated or described as part of one embodiment can be used in conjunction with another embodiment to result in further embodiments. Therefore, this subject matter is intended to encompass such modifications and variations that fall within the scope of the appended claims and their equivalents.

[0017] It will be understood that this disclosure is described in varying levels of detail in this application. In certain examples, details that are not necessary for a person skilled in the art to understand this disclosure, or that would make it difficult to recognize other details, may be omitted. The terms used herein are for the purpose of describing specific embodiments only and are not intended to limit beyond the scope of the appended claims. Unless otherwise defined, the technical terms used herein should be understood as commonly understood by a person skilled in the art to which this disclosure belongs. All devices and / or methods disclosed and claimed herein can be manufactured and performed without undue experimentation in light of this disclosure.

[0018] As understood herein, correspondence is intended to convey the relationship between components, parts, elements, etc., that interact with each other or are configured to have different intended relationships with one another. As used herein, “proximal” means the direction or location closest to the user (such as a medical professional, clinician, technician, operator, or physician, such terms are used interchangeably herein without intent to limit, including automated controller systems, etc.) when using the device (e.g., when introducing the device into a patient, or during implantation, placement, or delivery) and / or closest to the delivery device; “distal” means the direction or location furthest from the user when using the device (e.g., when introducing the device into a patient, or during implantation, placement, or delivery) and / or closest to the delivery device. “Longitudinal” means extending along the longitudinal or greater direction of an element. “Longitudinal axis” means extending along the longitudinal direction of an element, but not necessarily a straight line, and not necessarily maintaining a fixed shape if the element bends or curves. Also, “axial” generally refers to the direction along the longitudinal axis. However, it will be understood that references to axial or longitudinal movement relating to the system or its elements described above do not need to be strictly limited to axial and / or longitudinal movement along the longitudinal axis or central axis of the referenced element. "Center" means at least roughly bisecting the center point and / or being approximately equidistant from the periphery or boundary, and "central axis" means, with respect to an opening, a line that at least roughly bisects the center point of the opening and extends longitudinally along the length of the opening if the opening comprises, for example, a tubular element, strut, channel, cavity, or bore. In this specification, "lumen," "channel," "bore," or "passage" are not limited to circular cross-sections. In this specification, the "free end" of an element means the end of the element that does not extend further. Terms such as "at the end," "on the end," "adjacent to the end," and "along the end" may be used interchangeably in this specification without any intention of limitation unless otherwise specified, and it will be understood that they are intended to indicate general relative spatial relationships rather than strictly limited locations.For convenience, terms such as therapy, treatment, diagnosis, and procedure (including their various grammatical forms) may be used interchangeably without intent to limit them. Reference to any of these terms does not preclude other terms unless explicitly stated otherwise. Furthermore, terms such as treatment site, target site, and location may be used interchangeably without intent to limit them. Finally, any reference to a place or site "in" is intended to include its vicinity (e.g., along, adjacent, proximal, etc.) and / or surrounding area.

[0019] As commonly used herein, the term “ablation” generally refers to the removal of cells, either directly or indirectly, by the supply of energy in an electric field, and may include removal by loss of cellular function, cell lysis, coagulation, protein denaturation, necrosis, apoptosis, and / or irreversible electroporation. “Ablation” may also refer to the formation of a cauterization by ablation. In addition, the terms “undesirable tissue,” “target cells,” “target tissue,” “disease tissue,” “disease cells,” “tumor,” and “cell mass” may be used herein to refer to cells that are removed, or should be removed, entirely or partially by ablation, but are not intended to limit the application of any assembly, system, device, or method described herein. For example, such terms include ablation of both disease cells and specific surrounding cells, even if there is no explicit indication that such surrounding cells are diseased. Ablation performed by the assemblies, systems, devices, or methods described herein may be performed on cells within tissue or on cells located around biological lumens (e.g., vascular regions, mammary duct regions, or tubular regions). In accordance with the various principles of this disclosure, the devices, assemblies, systems, and methods disclosed herein may be configured for performing electroporation and / or IRE ablation.

[0020] In accordance with various principles of this disclosure, an energy supply treatment system includes an energy supply assembly, the energy supply assembly having a conductive elongated body defining an electrode portion along the energy supply assembly. More specifically, the conductive elongated body may be formed from 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 is positioned around the proximal portion of the first energy supply member to insulate the proximal portion of the first energy supply member (preventing energy from being supplied to the patient along the insulated portion of the first energy supply member). The distal portion of the first energy supply member that is not positioned within / covered by the insulating member defines a first electrode portion of the energy supply assembly. The first electrode portion may be considered to be defined / extending between the distal end of the first energy supply member and the distal end of the insulating member. An insulator may or may not be present around the other parts of the energy supply assembly. According to various principles of this disclosure, a lumen may be defined through the first energy supply member, and the lumen is configured to deliver a substance (e.g., a therapeutic substance) distally through the lumen, from the distal end of the lumen (e.g., adjacent to / at the distal end of the first energy supply member). Additionally, or alternatively, the lumen may be configured to draw or aspirate a substance from the target site and draw it proximal into and through the lumen from the distal end of the lumen (e.g., adjacent to or at the distal end of the first energy supply member). In some embodiments, the distal end of the first energy supply member may be configured as a sharp distal end and configured to puncture and / or perforate tissue, such as tissue, at the target site.Accordingly, in some embodiments, the first energy supply member of an energy supply assembly formed according to various principles of the present disclosure may not merely form an electrode portion of the energy supply assembly, but may be a material transport device having a lumen capable of delivering substances (e.g., treatment / therapeutic substances, irrigation materials, chemotherapeutic agents, immunogenic agents, gel isolation materials, embolic materials, etc.) and / or other devices (e.g., guidewires, fiducial markers, sensing devices (e.g., psi, pH, temperature, etc.), imaging devices, etc.) to a target site and / or aspirating / removing substances (e.g., fluids, tissue samples, etc.) from the target site.

[0021] The energy supply assembly may be delivered percutaneously, transcutaneously, or surgically, through a long, tubular member (e.g., a delivery sheath, catheter, or endoscopic working channel) inserted into the patient (e.g., into a body lumen within the patient through a natural anatomical passage or orifice). The energy supply member of the energy supply assembly may be coupled to an energy source and energized to apply an electric current to biological tissue by energizing its electrode. The energy source may be operable to generate an electric field between its electrode and another electrode connected to the energy source and having the opposite polarity (e.g., a return or ground).

[0022] Energy supply assemblies formed according to the various principles of this disclosure may be unipolar devices inserted into a patient, comprising a return electrode or ground electrode positioned outside the patient's body (as opposed to inside the patient, such as on the patient's epidermis). Alternatively, an energy supply assembly may be a bipolar device comprising at least two electrodes configured to be positioned and located in or near unwanted tissue (e.g., target cells, target site, treatment site, lesion tissue, lesion cells, tumor, cell mass) within a tissue treatment area (e.g., target area or target site) within the patient's body. Depending on the desired application, e.g., the diagnostic or therapeutic procedure to be performed, a particular electrode may be configured as either an anode or a cathode, or multiple electrodes may be configured such that at least one electrode is configured as an anode and at least one other electrode is configured as a cathode.

[0023] When an energy supply assembly formed according to various principles of this disclosure is placed in or near undesirable tissue, an energizing potential is applied to its electrodes to generate an electric field that exposes the tissue at the target site. The excitation potential (and the resulting electric field) can be characterized by various parameters, such as frequency, amplitude, and pulse width (pulse duration or pulse length). Suitable energy sources include electrical waveform generators, such as waveform generators capable of generating IRE waveforms, high-frequency IRE waveforms, nanopulse waveforms, and / or ablation waveforms. The energy source generates an electric field having desired characteristics for the procedure performed at the target site. For example, the electric field can be generated to have a characteristic waveform output with appropriate voltage, impedance, frequency, amplitude, pulse width, pulse delay, number of pulses per burst, number of bursts, and polarity. The current flows between the electrodes and through 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, an energy source may supply various waveforms in one or more pulse sequences that are tailored to the desired application.

[0024] In accordance with the various principles of this disclosure, electrodes of an energy supply assembly formed in accordance with the various principles of this disclosure (electrodes of a unipolar energy supply assembly, or one or both electrodes of a bipolar energy supply assembly) may be adjustable to change the electric field generated along the electrode portion. For example, typically, it may be desirable to adjust various properties of the electrodes and the energy field generated around them based on characteristics of the target site (e.g., the size of the tumor to be treated, and / or variations along the target site) which can be determined by pre-diagnosis, CT, MRI, endoscopy, and / or ultrasound, or other imaging techniques known to those skilled in the art, before the energy supply treatment system is delivered to the target site. Alternatively, it may be adjusted again after the energy supply treatment system has been delivered to the target site based on ultrasound or other imaging. In accordance with the various principles of this disclosure, the length of the electrode portion of the energy supply assembly may be adjustable to adjust the length and / or volume of the energy field generated around it when energy is applied. Optionally, the voltage may be adjusted to further adjust the energy field (e.g., primarily to adjust the radial diameter of the energy field).

[0025] In accordance with various principles of this disclosure, a unipolar energy supply assembly includes a first energy supply member. The energy supply member optionally has a lumen through which the first energy supply member can not only deliver energy therapy / treatment to a target site, but also deliver material to and / or remove material from the target site. In accordance with various further principles of this disclosure, the first energy supply member may have a sharp distal tip, and optionally, the distal end region of the energy supply member is configured to allow smooth puncture / entry of the energy supply member into the target site. Additionally or alternatively, in accordance with various further principles of this disclosure, the energy supply member of the energy supply assembly is adjustable, for example, in length.

[0026] In some embodiments, an energy supply assembly formed according to various principles of the Disclosure is a bipolar energy supply assembly. According to various principles of the Disclosure, a bipolar energy supply assembly includes a first energy supply member and a second energy supply member. According to various principles of the Disclosure, the first energy supply member optionally has a lumen defined through the first energy supply member, as described above with reference to a unipolar energy supply assembly. In some embodiments, one or both of the first and second energy supply members are adjustable and / or adjustable relative to each other. Additionally or alternatively, the distal portion of the bipolar energy supply assembly is configured to allow smooth puncture / entry of the energy supply member into the target site.

[0027] The energy supply assemblies, devices, systems, and methods described herein can be used in electroporation, irreversible electroporation (IRE), and / or electropermeabilization techniques to significantly increase the permeability of the cell plasma membrane by applying an external electric field (potential) to the cell membrane, such as improving the uptake of therapeutic substances by the cell. Optionally, the energy applied to the cell can alter (e.g., irreversibly alter) the properties of the cell membrane (e.g., porosity), inducing cell death (e.g., by apoptosis and / or necrosis). Such techniques can be advantageously used to treat / apply therapies without raising the temperature of surrounding tissues to a level that could cause permanent damage to the surrounding tissue, supporting structures, and / or local vascular systems. Therefore, the application of IRE pulses to cells can be an effective method for ablating large amounts of unwanted tissue with little to no harmful thermal effects on surrounding healthy tissue. This device can also be used in radiofrequency ablation to induce thermal coagulation of tissue.

[0028] Electrode device assemblies, systems, and various related methods will be described below with reference to examples illustrated in the accompanying drawings. References in this specification to “one embodiment,” “a certain embodiment,” “several embodiments,” and “other embodiments” indicate that one or more specific features, structures, concepts, and / or properties according to the principles of this disclosure may be included in connection with that embodiment. However, such references do not necessarily mean that all embodiments include a particular feature, structure, concept, and / or property, or that one embodiment includes all of them. Some embodiments may include one or more such features, structures, concepts, and / or properties in various combinations thereof. It should be understood that one or more of the features, structures, concepts, and / or properties described with reference to one embodiment may be combined with one or more of the features, structures, concepts, and / or properties of any of the other embodiments provided herein. That is, any of the features, structures, concepts, and / or properties described herein may be mixed and adapted to form a hybrid embodiment, and such hybrid embodiment is 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 separate or alternative embodiments are not necessarily mutually exclusive of other embodiments. Moreover, it should be understood that the various features, structures, concepts, and / or characteristics of the disclosed embodiments are independent and distinct from one another and may be used or presented individually or in various combinations to create alternative embodiments that are considered part of this disclosure. Accordingly, this disclosure is not limited to the embodiments specifically described herein, and because it would be extremely cumbersome to describe all the numerous possible and partial combinations of features, structures, concepts, and / or characteristics, the examples of embodiments disclosed herein are not intended to limit the broader aspects of this disclosure.The various dimensions provided herein are examples, and those skilled in the art should understand that they can easily determine a suitable range of standard deviation and acceptable variation therefrom, which are included in this disclosure and any related claims. The following description is merely an illustrative example of embodiments and is not intended to limit any broader aspects of this disclosure.

[0029] In the drawings, common features are identified by common reference elements, and for the sake of brevity and convenience, descriptions of common features are generally not repeated, without any intention of limitation. For clarity, not all components sharing the same reference number are numbered. In the following description, similar elements or components between the various illustrated embodiments are generally designated with the same reference number incremented by multiples of 100, and redundant descriptions are generally omitted for brevity. Furthermore, certain features in one embodiment may be used across different embodiments and may not necessarily be individually labeled when appearing in different embodiments.

[0030] Referring here to the drawings, an example of an embodiment of the energy supply treatment system 100 is illustrated in Figure 1. An energy supply assembly 110, and optionally a sheath 120 (extendable above the energy supply assembly 110), extends from the distal end 100d of the energy supply treatment system 100. The energy supply assembly 110 includes an energy supply member 1000 and an insulating member 2000 extending above at least the proximal portion of the energy supply member 1000. The energy supply member 1000 and its insulating member 2000 are typically configured to be selectively distally extendable from the distal end 120d of the sheath 120, for example, to protect the passage (e.g., an endoscope working channel, a body lumen, etc.) into which the sharp distal end 1000d (described in more detail below) of the energy supply member 1000 extends, and to be retractable proximal to expose at least the distal portion of the energy supply assembly 110. Optionally, an energy source is connected to the proximal end 100p of the energy supply treatment system 100 via a power connector 130 or the like. The power connector 130 may include a plug and / or cable and / or other wiring configured to connect to an energy source (via a power supply cable 132), which is known to those skilled in the art and can be selected by known means based on the type of energy supplied by the energy supply treatment system 100.

[0031] The energy supply treatment system 100 optionally includes a handle 140 operably connected to the energy supply assembly 110 for controlling elements of the energy supply assembly 110, such as controlling the position of the energy supply member 1000. The handle 140 may also be operably connected to the sheath 120 to control the position of the sheath 120 relative to the energy supply assembly 110, in a manner known to those skilled in the art. In some embodiments, the handle 140 includes a first control portion 142 operably connected to the sheath 120, the first control portion 142 being connected to a delivery device from which the energy supply assembly 110 and the sheath 120 can advance to the treatment site, and configured to adjust / control the position of the sheath 120 relative to the delivery device. The delivery device may be any desired delivery device, such as a delivery sheath or endoscope, having a lumen or working channel sized to allow passage of the energy supply assembly 110 and the sheath 120, and it should be understood that this disclosure is not limited in this respect. The handle 140 includes a second control unit 144 operably connected to the energy supply assembly 110, which is, for example, connected to the distal end 110d of the energy supply assembly 110 and configured to adjust / control the position of the distal end 110d of the energy supply assembly 110 relative to the sheath 120. For example, after the distal end 120d of the sheath 120 is positioned at or adjacent to the treatment site (e.g., by operation, control, etc., of the first control unit 142), the energy supply assembly 110 may be extended distally beyond the distal end 120d of the sheath 120 by operation, control, etc., of the second control unit 144.

[0032] In accordance with various principles of this disclosure, the energy supply assembly 110 is an elongated, flexible assembly that can be navigated through the patient's body, for example, through natural orifices and / or through a tubular, elongated member inserted into the patient's body. More specifically, the energy supply member 1000 of the energy supply assembly 110 may be elongated and sufficiently flexible so that it can be inserted transcatheterally into the body (e.g., endoscopically, as opposed to percutaneous insertion) and navigated through potentially meandering pathways within the body, or at least bend or swivel together with / within natural nonlinear anatomical structures. Additionally or alternatively, the energy supply member 1000 may have sufficient elasticity so as not to break when navigated. Those skilled in the art will understand that, based on the material, size, shape, configuration, and / or dimensions of the energy supply member 1000, appropriate length, flexibility, resilience, and / or other properties / characteristics of the energy supply member 1000 used in accordance with the various principles of this disclosure, and that this disclosure is not necessarily limited to specific parameters. In some embodiments, the energy supply assembly 110 may be formed in accordance with the various principles of this disclosure to include one or more components, elements, members, etc. whose size, shape, configuration, and / or dimensions (relative to other components, elements, members, etc. of the energy supply assembly 110) are adjustable, as will be described in more detail below.

[0033] In some embodiments, the energy supply member 1000 of the energy supply assembly 110 is a trocar (solid or having a lumen inside), needle, tip, tissue puncture device / electrode capable of easily puncturing tissue / organ / tumor mass with or without coring the tissue. The energy supply member 1000 may be any of various needle types, including, but not limited to, lancet, Franzene, trocar, Sprotte, Pencil-Point, Chiba, Turner, Madayag, Greene, Menghini, and Westcott. In some embodiments, the energy supply member 1000 may have a fine needle aspiration (FNA) tip configuration or a fine needle biopsy (FNB) tip configuration. In some embodiments, the energy supply member 1000 has a flexibility selected to accommodate ease of use with various delivery devices (such as delivery devices configured for transcatheter delivery) and / or flexibility selected to have the ability to retract and / or extend the energy supply member 1000 to a desired position without having an unacceptable shape setting within a meandering anatomical structure. In some embodiments, the energy supply member 1000 may be as small as a 34Ga needle or up to a 6Ga needle, including incremental sizes in between. The energy supply member 1000 may be of any length appropriate for insertion into the patient to reach a desired target site.

[0034] In accordance with the various principles of this disclosure, the needle does not necessarily have to have a sharp distal end and / or a defined lumen inside it, but may be energizable to supply energy to a treatment site for therapeutic, diagnostic, or procedure purposes. Voltage, current (e.g., waveform, pulse pattern, magnitude and nature of energy pulse packets, frequency, etc.), power, and other parameters are adjusted as needed or as instructed with respect to the specific therapy, procedure, or technique being performed, and this disclosure is not limited by such details. The power connector 130 is electrically connected to the energy supply member 1000 to supply the energy supply member 1000 with a desired form of energy. Furthermore, the energy supply member 1000 may be formed from a conductive material (e.g., medical-grade / biocompatible stainless steel, platinum, gold, nitinol, cobalt-chromium alloy, nickel-cobalt alloy such as MP35N, or other alloys, or materials plated with conductive material) that can establish tissue contact / conductivity in order to supply sufficient energy to ablate the tissue and / or to apply sufficient energy to achieve tissue ablation and / or irreversible electroporation within the electric field of the energy supply member 1000.

[0035] As illustrated in the detailed view of Figure 1A, along detail 1A of Figure 1, an illustrated example of an embodiment of an energy supply member 1000 formed according to various principles of the present disclosure optionally has an elongated body 1002 terminating at a distal end 1002d, including a sharp distal tip 1004. The distal end 1002d of the elongated body 1002 of the energy supply member may be in the same range as the distal end 1000d of the energy supply member 1000, and it will be understood that, unless expressly stated, references to the distal end 1000d or the distal end 1002d may be interchangeable without the intention of limitation. Furthermore, according to various principles of the present disclosure, a lumen 1003 is defined through the energy supply member 1000 and terminates at a distal opening adjacent to / at the sharp distal tip 1004 of the elongated body 1002.

[0036] Additionally, or alternatively, an example of an embodiment of an insulating member 2000, illustrated in Figure 1A and formed according to various principles of the present disclosure, has an elongated body 2002 defining a lumen 2003 over which the energy supply member 1000 extends. The distal end 2002d of the elongated body 2002 of the insulating member may be in the same range as the distal end 2000d of the insulating member 2000, and it will be understood that, unless expressly stated, references to the distal end 2000d or the distal end 2002d may be interchangeable without any intention of limitation.

[0037] As shown in Figure 1A and the cross-sectional view in Figure 2 taken along line II-II in Figure 1A, the distal portion of the energy supply member 1000 extends distally beyond the distal end 2002d of the elongated body 2002 of the insulating member 2000, defining the electrode portion 1010 of the energy supply assembly 110 distal to the distal end 2000d of the insulating member 2000. More specifically, the electrode portion 1010 is defined along the distal longitudinal range of the energy supply member 1000 between the distal end 1002d of its elongated body 1002 and the distal end 2002d of the elongated body 2002 of the insulating member 2000, which is positioned on the proximal portion of the elongated body 1002 of the energy supply member 1000. The insulating member 2000 is formed from an insulating material (e.g., polymer extrusion, polymer heat shrinkage, non-metallic braided shaft, composite shaft, etc.) such that only the portion of the energy supply member 1000 extending beyond the distal end 2002d of the elongated body 2002 of the insulating member 2000 functions as an electrode (the proximal portion of the elongated body 1002 of the energy supply member 1000 within the insulating member 2000 is insulated / shielded and therefore does not apply / supply energy to the patient). Accordingly, the distance between the distal end 1002d of the elongated body 1002 of the energy supply member and the distal end 2002d of the elongated body 2002 of the insulating member defines the length of the electrode portion 1010 of the energy supply assembly 110. The proximal portion 1020 of the elongated body 1002 of the energy supply member, located near the electrode portion 1010, is insulated by the insulating member 2000, and therefore can be considered to simply function as an insulated needle that has no electrical therapeutic function other than conducting / supplying energy to the electrode portion 1010 at the distal end 1002d of the elongated body 1002 of the energy supply member.

[0038] As can be understood, according to the various principles of this disclosure, an example of an embodiment of the energy supply assembly 110 illustrated in Figure 2 provides a unique structure for supplying therapeutic energy to a patient. Such a structure may be considered a unipolar needle, such as a unipolar IRE needle. Not only does the energy supply assembly 110 have an electrode area (which may also be called a probe) for supplying or providing energy, the energy supply assembly 110 may also have a lumen for supplying a substance (e.g., a drug, treatment, therapy, or irrigation fluid such as saline) or for aspirating a substance (e.g., a fluid or other substance such as a tissue sample or something that may need to be removed from the treatment site). For example, the distal end 1002d of the elongated body 1002 of the energy supply member may be inserted into a lesion, and drugs such as chemotherapy may be applied before, after, or during treatment (e.g., in conjunction with energy therapy applied by the electrode portion 1010 of the energy supply assembly 110). Because IRE allows for the opening of pores into cells, the delivery of treatment substances by electroporation electrodes, as achievable by the energy supply assembly 110 of this disclosure, can perform a synergistic function, enabling chemotherapy to be more readily taken up by cells, thereby increasing the effectiveness of chemotherapy.

[0039] In one embodiment illustrated in Figure 2, the energy supply member 1000 may have a substantially constant outer diameter, and the insulating member 2000, formed on or otherwise disposed on the energy supply member 1000, has an outer diameter larger than that of the energy supply member 1000. Alternatively, one embodiment of the energy supply assembly 110' illustrated in Figure 3 has an energy supply member 1100 having a proximal portion 1120 with a step formed at the shoulder portion 1106, with respect to an electrode portion 1110 defined along the distal portion of the energy supply member 1100. In some embodiments, the proximal portion 1120 of the energy supply member 1100 has an outer diameter 1120D reduced with respect to the outer diameter 1110D of the electrode portion 1110 defined at the distal end 1102d of the elongated body 1102 of the energy supply member. Such a reduced outer diameter 1120D provides space around the elongated body 1102 of the energy supply member for the insulating member 2100 to fit around it, as shown in Figure 3 (the proximal portion 1120 of the energy supply member 1100 fits into a lumen 2103 defined through the insulating member 2100). In some embodiments, the outer diameter 2100D of the insulating member 2100 may be substantially equal to the outer diameter 1110D of the electrode portion 1110 (and thus substantially coplanar). Such a configuration may allow for smoother tissue puncture by the sharp distal tip 1104 of the elongated body 1102 of the energy supply member. The various elements of the energy supply assembly 110' shown in Figure 3 are indicated by the same reference numerals as in Figure 2 plus 100 to indicate similar or identical structures or features, and it will be understood that redundant descriptions are generally omitted for brevity. Furthermore, an example of an embodiment of the energy supply assembly 110' shown in Figure 3 can be used in conjunction with various components of an example of an embodiment of the energy supply treatment system 100 shown in Figure 1, as can be understood by those skilled in the art.

[0040] Various modifications to the basic structure, characteristics, features, properties, etc., of the energy supply members and / or insulating members of the energy therapy assembly of this disclosure may be made in accordance with various principles of this disclosure. For example, the number of energy supply members and / or insulating members, their relative positioning to each other, the manner in which the energy supply members and / or insulating members are connected, the size, shape, configuration, and / or dimensions of the energy supply members and / or insulating members, and other structures, characteristics, features, properties, etc., of the energy supply members and / or insulating members may be modified in accordance with various principles of this disclosure to form an energy therapy assembly, as described herein with reference to various further drawings accompanying this disclosure.

[0041] It may be desirable to make various characteristics of the energy supply portion (e.g., the electrode portion) of the unipolar needle adjustable in order to adjust for variations in the size and shape of the treatment site. For example, a longer electrode generally produces a longer ablation volume, which may be required depending on the nature and characteristics of the treatment site. Additionally, or alternatively, the applied voltage can be increased to further increase the radial diameter of the area being ablated. In some embodiments, according to various principles of this disclosure, an energy supply assembly as described herein may be adjustable in size, shape, configuration, and / or dimensions.

[0042] An example of an embodiment of an energy supply treatment system 200 having an adjustable (e.g., adjustable length) unipolar energy supply assembly 210 formed in accordance with various principles of this disclosure is shown in Figures 4A and 4B. Various elements of the example embodiment of the energy supply treatment system 200 illustrated in Figures 4A and 4B are indicated by the same reference numerals as in Figures 1 and 2 plus 100 to indicate similar or identical structures or features, and it should be understood that redundant descriptions are generally omitted for the sake of brevity.

[0043] Similar to an example of the embodiment shown in Figure 2, the energy supply member 1200 has an electrode portion 1210 defined by a portion of the energy supply member 1200 that extends distally to the distal end 2200d of the insulating member 2200 (between the energy supply member end 1200d / 1202d and the insulating member end 2200d / 2202d). However, as can be understood by comparing the energy supply assembly 210 extending from the distal end 200d of the energy supply treatment system 200 illustrated in Figures 4A and 4B, the energy supply member 1200 is movable relative to the insulating member 2200 (for example, sliding proximal to the insulating member 2200 or sliding distally from the insulating member 2200) to change its exposed length forming the electrode portion 1210. More specifically, in one embodiment shown in Figure 4A, the distal end 2200d of the insulating member 2200 is positioned at a first distance from the distal end 1200d of the energy supply member 1202 (proximal to the distal end 1200d). In another embodiment shown in Figure 4B, the distal end 2200d of the insulating member 2200 is positioned at a second distance from the distal end 1200d of the energy supply member 1202 (proximal to the distal end 1200d) (after the energy supply member 1100 and the insulating member 2200 have been moved relative to each other), and the second distance is greater than the first distance. Therefore, the electrode portion 1210 has a first length corresponding to the first distance in Figure 4A and a second length corresponding to the second distance in Figure 4B, with the second length being greater than the first length. The length of the electrode portion 1210 can be changed by the relative movement of the energy supply member 1200 and the insulating member 2200, such as by moving the insulating member 2300 proximal to the energy supply member 1200 and / or extending the energy supply member 2300 distal to the insulating member 2200.It should be understood that the distance between the distal end 1200d of the energy supply member 1200 (and the distal end 1202d of its elongated body 1202) and the distal end 2200d of the insulating member 2200 (and the distal end 2202d of its elongated body 2202), and therefore the length of the electrode portion 1210 defined between these ends 1200d, 2200d, may be variable with relatively infinite adjustability or adjustable in predetermined increments depending on the relative movement (e.g., sliding) of the energy supply member 1200 and the insulating member 2200. To be understood, the energy supply member 1200 and the insulating member 2200 may be able to advance distally from the sheath 120 or retract proximally into the sheath 120 in the manner described above with respect to an example embodiment of the sheath 220 illustrated in Figure 1, and for further applicable explanations that will be understood by those skilled in the art, refer to Figure 1.

[0044] In some embodiments, in an example of an embodiment of the energy supply treatment system 200 as illustrated in Figures 4A and 4B, a handle 240 may be operably connected to one or more elements of the energy supply assembly 210 to facilitate adjustment of the energy supply assembly 210 and to control its movement. More specifically, in accordance with various principles of the present disclosure, an example of an embodiment of the energy supply treatment system 200 as illustrated in Figures 4A and 4B includes a handle 240 having a first control part 242, a second control part 244, and a third control part 246. The first control part 242 is operably connected to the sheath 220 and may be substantially similar (e.g., in form and / or function) to the first control part 142 described above with reference to Figure 1, and for brevity, its description is referred to without intent to limit. The second control section 244 is operably connected to the energy supply member 1200 of the energy supply assembly 110, and is configured to control, for example, the position of the distal end 1200d of the energy supply member 1200 relative to the sheath 220. The second control section 244 may be substantially similar (for example, in form and / or function) to the second control section 144 described above with reference to Figure 1, and for the sake of brevity, its description is referred to without intent to limit. In one example of an embodiment of the handle 240 shown in Figures 4A and 4B, the third control section 246 is operably connected to the insulating member 2200, and is configured to control, for example, the position of the distal end 2202d of the insulating member 2200 relative to the distal end 1200d of the energy supply member 1200. In some embodiments, the insulating member 2200 is slidable relative to the energy supply member 1200, for example, when the third control section 246 is sliding or otherwise moving. For example, the third control unit 246 may be movable proximally (for example, from the position shown in Figure 4A to the position shown in Figure 4B), thereby allowing the insulating member 2200 to be moved proximally relative to the energy supply member 1200, and increasing the length of the electrode portion 1210 of the energy supply member 1200.Optionally, to reduce friction between the insulating member 2200 and the energy supply member 1200, the insulating member 2200 may include an inner tubular element formed from a material that facilitates movement relative to the energy supply member 1200. For example, in some embodiments, the insulating member 2200 may be formed from a metal hypotube coated with an insulating material such as a polymer insulating material (e.g., extrusion, heat shrinkage, etc.). Other configurations are within the scope and spirit of the disclosure, and the disclosure is not limited in this respect.

[0045] In accordance with the various principles of this disclosure, various of the above principles may be applied to form a bipolar, rather than unipolar, adjustable energy supply assembly 310 (e.g., comprising a bipolar needle probe as shown in Figure 5). For example, one example of an embodiment of the adjustable bipolar energy supply assembly 310 shown in Figure 5 has a first energy supply member 1300, on which a first insulating member 2300 is positioned. The first energy supply member 1300 and the first insulating member 2300 may be substantially similar to the energy supply member 1200 and insulating member 2200 described above with reference to an example of an embodiment of the adjustable unipolar energy supply assembly 210 shown in Figures 4A and 4B. Accordingly, for the sake of brevity, and without the intention of limitation, the same reference numerals used in Figures 4A and 4B plus 100 are used for the same or similar elements shown in Figure 5, and for the sake of brevity, redundant descriptions are omitted (the descriptions provided above are referred to as applicable to the same or similar elements in Figure 5). However, in contrast to the adjustable energy supply assembly 210 illustrated in Figures 4A and 4B, the adjustable energy supply assembly 310 illustrated in Figure 5 has a second electrode that can be insulated as well as the first electrode. More specifically, the adjustable bipolar energy supply assembly 310 shown in Figure 5 includes a second energy supply member 3300 and a second insulating member 4300 extending over at least the proximal portion of the second energy supply elongated member 3300. The second energy supply member 3300 may be a conductive tubular member through which the first energy supply member 1300 and the first insulating member 2300 can advance distally and / or retract proximal. In some embodiments, the second energy supply member 3300 may be a conductive hypotube such as a metal (e.g., medical-grade / biocompatible stainless steel, platinum, gold, nitinol, cobalt-chromium alloy, nickel-cobalt alloy such as MP35N, other alloys, or materials plated with conductive materials) hypotube, and may be formed from the same, similar, or different material as the material on which the first energy supply member 1300 is formed.The second insulating member 4300 may be similar to, substantially identical to, or different from the first insulating member 2300, except in dimensions (for example, the second insulating member 4300 may be larger than the first insulating member 2300 so that the first energy supply member 1300, the first insulating member 2300, and the second energy supply member 3300 can extend through the second insulating member 4300). The first insulating member 2300 and the second insulating member 4300 may be substantially identical, but they do not necessarily have to be identical, as each insulating member 2300, 4300 may have slightly different purposes and needs for the energy supply assembly 310 to function correctly and safely. In some embodiments, the second energy supply member 3300 supports insulating members 4300 arranged around it. As can be understood from a practical standpoint, the second energy supply member 3300 should have a complete layer of insulation between itself and the first energy supply member 1300, as provided by the first insulating member 2300 (whether adjustable or not), and also a layer of insulation provided by the second insulating member 4300 (whether adjustable or not). As in the energy supply assembly 210 illustrated in Figures 4A and 4B, a sheath (not shown) may extend over the energy supply members 1300, 3300 and insulating members 2300, 4300 of the energy supply assembly 310 illustrated in Figure 5. Such a sheath may be substantially identical in properties and characteristics to the sheath 120 described above and is therefore referred to as an applicable description for a sheath usable with the energy supply assembly 310 illustrated in Figure 5.

[0046] The energy supply members 1300, 3300 of an example embodiment of the adjustable bipolar energy supply assembly 310 illustrated in Figure 5 provide a needle electrode / probe with similar advantages to those described with respect to the unipolar energy supply assemblies 110, 110', 210 described above, enabling energy-based therapy along with material delivery-based therapy and / or material sampling and / or aspiration. In addition, similar to the adjustable unipolar energy supply assembly 210 described above, the adjustable bipolar energy supply assembly 310 illustrated in Figure 5 allows for the adjustment of its energy supply members (e.g., length). However, the energy supply assembly 310 illustrated in Figure 5 includes two energy supply members 1300, 3300, allowing for the adjustment of the first energy supply member 1300 and the optional adjustment of the second energy supply member 3300. Furthermore, the energy supply assembly 310 illustrated in Figure 5 allows for the adjustment of the insulating member 2300 between the first energy supply member 1300 and the second energy supply member 3300, thereby adjusting the distance between the two electrodes of the bipolar needle probe / electrode of the energy supply assembly 310, and thus adjusting the active surface area of ​​the energy supply assembly 310. Specifically, similar to the adjustable unipolar energy supply assembly 210 shown in Figures 4A and 4B, the first energy supply member 1300 of the energy supply assembly 310 defines a first electrode portion 1310 between the distal end 1300d of the first energy supply member 1300 (e.g., the distal end 1302d of the elongated body 1302 of the first energy supply member 1300) and the distal end 2300d of the first insulating member 2300 (e.g., the distal end 2302d of the elongated body 2302 of the first insulating member 2300). Furthermore, similar to the adjustable unipolar energy supply assembly 210 shown in Figures 4A and 4B, the first energy supply member 1300 and the first insulating member 2300 are movable relative to each other, thereby allowing adjustment of the length of the electrode portion 1310 of the energy supply member 1300, defined between the energy supply member end 1300d / 1302d and the insulating member end 2200d / 2202d.

[0047] In one example of an embodiment of the adjustable bipolar energy supply assembly 310 shown in Figure 5, the second energy supply member 3300 defines the second electrode portion 3310 of the energy supply assembly 310 between the distal end 3300d of the second energy supply member 3300 (for example, the distal end 3302d of the elongated body 3302 of the second energy supply member 3300) and the distal end 4300d of the second insulating member 4300 (for example, the distal end 4302d of the elongated body 4302 of the second insulating member 4300). Similar to the first energy supply member 1300, the second energy supply member 3300 defines a second electrode portion 3310 between the distal end 3300d of the second energy supply member 3300 (for example, the distal end 3302d of the elongated body 3302 of the second energy supply member 3300) and the distal end 4300d of the second insulating member 4300 (for example, the distal end 4302d of the elongated body 4302 of the second insulating member 4300). Furthermore, similar to the first energy supply member 1300 and the first insulating member 2300, the second energy supply member 3300 and the second insulating member 4300 are movable relative to each other, thereby allowing adjustment of the length of the second electrode portion 3310 of the second energy supply member 3300, defined between the distal end 3300d / 3302d of the second energy supply member and the distal end 4200d / 4202d of the second insulating member.

[0048] During use, energy (e.g., electric current) is supplied to the energy supply assembly 310 and flows to and between the first electrode portion 1310 and the second electrode portion 3310 of the energy supply assembly 310. As can be understood, one of the first electrode portion 1310 and the second electrode portion 3310 functions as the anode of the bipolar energy supply assembly 310, and the other of the first electrode portion 1310 and the second electrode portion 3310 functions as the cathode of the bipolar energy supply assembly 310. Any or each of the first energy supply member 1300, the first insulating member 2300, the second energy supply member 3300, and the second insulating member 4300 may be movable relative to each other, thereby allowing the length, distance, etc., of the electrode portions 1310, 3310 and / or insulating members 2000, 4300 to be changed (for example, the distance between the distal end of the proximal second energy supply member 3300 and the proximal end of the distal first energy supply member 1300 adjacent to the distal end 2300d of the first insulating member 2300 to be changed), thereby allowing the relevant and other relevant properties and features of the energy supply assembly 310 to be changed, as can be understood by those skilled in the art. Furthermore, any or each of the first energy supply member 1300, the first insulating member 2300, the second energy supply member 3300, and the second insulating member 4300 can be operably connected to a movable (e.g., sliding) associated handle component, allowing the associated members 1300, 2300, 3300, and 4300 operably connected to the handle component to be retracted distally or advanced / extended axially. The handle and associated components as described above can be operably connected to an example of an embodiment of the energy supply assembly 310 illustrated in Figure 5.

[0049] It should be understood that, in order to be easily navigated within the patient's body, the members 1300, 2300, 3300, and 4300 of the energy supply assembly 310 illustrated in Figure 5 typically need to be small enough to obtain an appropriate overall size and flexibility for the navigation, delivery, and use of the energy supply assembly 310. Furthermore, as described above, standard fine-needle aspiration cytology (FNA) devices have the needle housed within a protective sheath that protects the working channel of the delivery device (e.g., endoscope) used to deliver the energy supply assembly and / or the patient's tissue from being punctured by the tip of the needle. For example, as illustrated with reference to Figure 1, the energy supply assembly 110 may be housed within the sheath 120 with the sharp distal tip 1004 of the energy supply member 1000 located proximal to the distal end 120d of the sheath 120 and delivered to the target site. After the protective sheath passes through the delivery device and extends outward from the distal end of the delivery device, the FNA needle advances outward from the distal end of the sheath during puncture, and the sheath typically does not enter the tissue. A similar sheath may also be used in one embodiment of the energy supply assembly 310 shown in Figure 5.

[0050] In accordance with various principles of this disclosure, as shown in Figures 6A, 6B, and 6C, the adjustable bipolar energy supply assembly 410 may be configured such that a proximal second energy supply member 3400 forms a protective sheath for a distal first energy supply member 1400, which is in the form of a needle, such as an FNA needle. More specifically, an example of an embodiment of the adjustable bipolar energy supply assembly 410 shown in Figures 6A, 6B, and 6C has a first energy supply member 1400 with a first insulating member 2400 positioned around it. The first energy supply member 1400 and the first insulating member 2400 may be movable relative to each other (for example, in the embodiments described above with respect to the example embodiment shown in Figures 4A and 4B, to adjust the length of the electrode portion 1410 of the first energy supply member 1400) or may be static relative to each other and well coupled together (to increase stability, buckling strength, etc., and generally to fix the length of the electrode portion 1410). This portion of the energy supply assembly 410 may be substantially identical or similar to the energy supply member 1000 and insulating member 2000 of the energy supply assembly 110 shown in Figures 1 and 2. Accordingly, similar reference numerals plus 100 are used to indicate identical or similar elements, and for brevity, without intent to limit, the above description may be referenced with respect to such elements in Figure 1. Optionally, the outer diameter of the distal portion of the first energy supply member 1400 forming the electrode portion 1410 may have substantially the same outer diameter as the first insulating member 2400, as in an example of an embodiment of the energy supply assembly 110' shown in Figure 3, and for further details, for brevity, without intent to limit, the description in Figure 3 may be referenced.

[0051] In one embodiment of the energy supply assembly 410 illustrated in Figures 6A, 6B, and 6C, the second energy supply member 3400 is formed from a generally tubular member on which the first energy supply member 1400 and the first insulating member 2400 extend. According to various principles of the present disclosure, the second energy supply member 3400 may be conductive in order to form a second electrode portion 3410. As shown in Figure 6C, a second insulating member 4400 may be positioned on the second energy supply member 3400 to define a second electrode portion 3410 between the distal end 3400d of the second energy supply member 3400 (for example, the distal end 3402d of the elongated body 3402 of the second energy supply member 3400) and the distal end 4400d of the second insulating member 4400 (for example, the distal end 4402d of the elongated body 4402 of the second insulating member 4400). According to various principles of this disclosure, the second energy supply member 3400 may be formed from a hypotube, and the second insulating member 2400 may be formed from an insulating material similar to that of the second energy supply member 3300 and the second insulating member 4300 of the energy supply assembly 310 described above with reference to Figure 5. The second energy supply member 3400 may support the insulating member 4400 positioned around it. However, in contrast, instead of the second energy supply member 3400 and the second insulating member 4400 being movable relative to each other, the second energy supply member 3400 and the second insulating member 4400 are generally static relative to each other and can be sufficiently bonded together. Thus, the proximal electrode of the energy supply assembly 410, as defined by the second energy supply member 3400 and the second insulating member 4400, as illustrated in Figures 6A, 6B, and 6C, is sufficiently rigid, protecting the sharp distal tip 1404 of the first energy supply member 1400, thereby providing an FNA protection structure, which is usually provided by a separate sheath. Furthermore, the second energy supply member 3400, with the second insulating member 4400 bonded around it, can have better buckling strength than members that are movable relative to each other, because the second insulating member 4400 is mechanically supported by the second energy supply member 3400.However, it is understood that it may be desirable for each of the elements 1400, 2400, 3400, and 4400 of the energy supply assembly 410 to be movable relative to one another, for example in any of the above embodiments, for further adjustability of the energy supply assembly 410.

[0052] During use, the distal electrode, defined by the first energy supply member 1400 and the first insulating member 2400, is movable (e.g., slidable) relative to the proximal electrode formed by the second energy supply member 3400 and the second insulating member 4400. As can be understood, the lengths of the respective electrode portions 1410, 3410 of the distal and proximal electrodes can be fixed (by fixing the first insulating member 2400 to the first energy supply member 1000 and the second insulating member 2400 to the second energy supply member 4400). However, the distal and proximal electrodes may be movable relative to each other by moving the first energy supply member 1400 distally to the second energy supply member 3400, or by moving the second energy supply member 3400 proximal to the first energy supply member 1400, for example. The relative movement of the distal and proximal electrodes adjusts the length of the insulation between the electrode sections 1410 and 3410, affecting the overall length of the adjustable bipolar energy supply assembly 410, and thus affecting, for example, the therapeutic volume of the energy supply assembly 410.

[0053] In one embodiment of the energy supply assembly 410 illustrated in Figures 6A, 6B, and 6C, the sharp distal tip 1404 of the distal electrode defined by the first energy supply member 1400 can first be delivered to the target site T, as shown in Figure 6A, with the tip positioned (e.g., retracted proximally) within the proximal electrode defined by the second energy supply member 3400. In such an embodiment, the delivery device (e.g., an endoscope) or the patient's biological structure to which the energy supply assembly 410 is delivered is protected from the sharp distal tip 1404. Once the energy supply assembly 410 (specifically, the distal end 3400d of the second energy supply member 3400) is positioned at the target site T (e.g., tissue), the distal end 3400d of the second energy supply member 3400 can be brought into contact with the target site T, as shown in Figure 6A, for example, when it extends distally from the distal end of the delivery device. Next, as shown in Figure 6B, the sharp distal tip 1404 of the first energy supply member 1400 may extend distally from the second energy supply member 3400 (for example, distally beyond the distal end 3400d of the energy supply member 1400 and / or the distal end 3402d of its elongated body 3402) to puncture the target site T. At this stage, the second energy supply member 1400 does not need to be advanced into the target site T. However, as can be understood, the advancement of the first energy supply member 1400 into the target site T may facilitate the subsequent advancement of the second energy supply member 3400 into the target site T by creating an initial puncture / opening in the target site T. The second energy supply member 3400 may then be advanced into the target site T, as shown in Figure 6C. Once both electrode portions 1410 and 3410 of the energy supply assembly 410 are positioned as desired relative to the target site T, the adjustable bipolar energy supply assembly 410 can be adjusted as desired (as described above) for the delivery and / or removal of material through the lumen 1403 of the first energy supply member 1400, and / or for the supply of energy to and between the first electrode portion 1410 and the second electrode portion 3410.

[0054] An example of an embodiment of a handle 440 for controlling the movement of one or more elements of an energy supply assembly 410 illustrated in Figures 6A, 6B, and 6C, is shown in Figures 7A, 7B, and 7C. Similar to the example embodiment of the handle 140 shown in Figure 1, and the example embodiment of the handle 240 shown in Figures 4A and 4B, the example embodiment of the handle 440 shown in Figures 7A, 7B, and 7C has a first control portion 442 operably connected to a sheath 420. The first control portion 442 may be substantially similar (e.g., in form and / or function) to the first control portion 142 described above with reference to Figure 1, and / or the first control portion 242 described above with reference to Figures 4A and 4B. Thus, similar reference numbers plus 300 are used to indicate the same or similar elements, and for brevity, the above description relating to such elements in Figure 1 can be referenced without intent to limit.

[0055] When the first energy supply member 1400 and the second energy supply member 2400 are arranged as shown in Figure 6A, the various control parts 442, 444, 446, and 448 of the handle 440 may be as shown in Figure 7A. When the handle is in the position shown in Figures 6B and 6C (with the first energy supply member 1400 extending from the second energy supply member 3400), the user may adjust and set (for example, fix in a predetermined position) the position of any position control element 448 relative to the second control part 444 in order to set the distance between the first energy supply member 1400 and the second energy supply member 3400. As shown in Figure 6B, in order to advance the first energy supply member 1400 of the energy supply assembly 410 through the target site T (for example, to puncture tissue / cells at the target site T), the user advances the second control part 444 (operably connected to the first energy supply member 1400) relative to the first control part 442 (operably connected to the sheath 420) by sliding the second control part 444 along a proximal base or shaft 445, as shown in Figure 7B (for example, longitudinally / distally relative to the position shown in Figure 7A). As the second control portion 444 is advanced from the position shown in Figure 7A to the position shown in Figure 7B, the second control portion 444 also moves distally to the third control portion 446 (operably connected to the second energy supply member 3400), thereby extending the first energy supply member 1400 distally from the second energy supply member 3400, as shown in Figures 6B and 7B, so that the distal end 1400d of the first energy supply member 1400 is located distal to the distal end 3400d of the second energy supply member 3400. The sharp distal tip 1404 of the first energy supply member 1400, together with the elongated body 1402 of the energy supply member 1400 and the insulating member 2400 surrounding the energy supply member 1400, may extend into the tissue, as shown in Figure 6B. Optionally, the second control unit 444 can be advanced distally until it reaches the end of the catch or slot of the handle 440 and / or the first control unit 442 (to advance the electrode 1410 into the patient's body).If the position control element 448 is present (and is generally fixed to the second control portion 444), then, as shown in Figure 7B, distal advancement of the second control portion 444 causes the position control element 448 to advance distally toward the third control portion 446 until it contacts the third control portion 446. Further advancement of the second control portion 444 relative to the position in Figure 7B, as shown in Figure 7C, also advances the contacting position control element 448 and therefore the third control portion 446. As a result, the entire energy supply assembly 410 (including the second energy supply member 3400 and the surrounding insulating member 4400) is advanced into the tissue, as shown in Figure 6C. Next, the energy source can be connected to the energy supply assembly 410 via a power connector 430 connected to the proximal end 400p of the energy supply treatment system 400, in the manner described above with respect to the energy supply treatment system 100 shown in Figure 1, and energy can be supplied.

[0056] In accordance with various principles of this disclosure, it may be desirable for an adjustable bipolar energy supply system to have an energy supply assembly in which the electrodes have the same or substantially the same external dimensions (e.g., diameter) to enable smoother tissue puncture at the target site. In one example of an embodiment of the adjustable bipolar energy supply assembly 510 shown in Figures 8A and 8B, the first (distal) energy supply member 1500 and the second (proximal) energy supply member 3500 have substantially the same external dimensions (e.g., diameter). Initial tissue puncture is performed in the form of the energy supply assembly 510 as illustrated in Figure 8A, which can be considered a compressed form. Such a form avoids an excessively flexible region between the electrode portion 1510 of the first energy supply member 1500 and the electrode portion 3510 of the second energy supply member 3500, thereby avoiding potential interference during puncture that may occur due to an excessively flexible device. It will be understood that various elements of the example embodiment of the energy supply assembly 510 shown in Figures 8A and 8B are similar to the elements of the example embodiment of the energy supply assembly 410 shown in Figures 6A to 6C (except, for example, the relative dimensions of the elements). Accordingly, the same reference numerals plus 100 are used to indicate the same or similar elements, and for the sake of brevity, the above description of such elements in Figures 6A to 6C may be referenced without the intention of limitation. Furthermore, it will be understood that the energy supply assembly 510 shown in Figures 8A and 8B may be used in an energy supply treatment system 400 as shown in Figures 7A to 7C.

[0057] In the configuration illustrated in Figure 8A, it will be understood that energy can be delivered to the energy supply assembly 510. In particular, in the configuration shown in Figure 8A, the first (distal) electrode portion 1510 (formed by the first energy supply member 1500) and the second (proximal) electrode portion 3510 (formed by the second energy supply member 3500) may be in contact with each other and may be short-circuited together and operated in unipolar mode as if they were a single electrode. In one illustrated example of one embodiment, if the outer diameter of the first energy supply member 1500 and the outer diameter of the second energy supply member 3500 are substantially equal, the first electrode portion 1510 and the second electrode portion 3510 may have the same or substantially the same diameter.

[0058] In some embodiments, after the energy supply assembly 510 is positioned as desired relative to the target site, the first (e.g., distal) energy supply member 1500 and the second (e.g., proximal) energy supply member 3500 can be separated (e.g., moved relative to each other). For example, the second energy supply member 3500 can be moved proximal (e.g., retracted relative to the first energy supply member 1500), and / or the first energy supply member 1500 can be moved further distally relative to the second energy supply member 3500, thereby separating the first electrode portion 1510 and the second electrode portion 3510 by a distance determined by a medical professional to be appropriate for the treatment / procedure performed using the energy supply assembly 510 (e.g., delivery of energy to the energy supply assembly 510 to produce IRE ablation that can cover an entire tumor). It will be understood that the separation distance between the first electrode portion 1510 and the second electrode portion 3510 may be determined taking into consideration the avoidance of an electric arc between them when the electrodes 1510 and 3510 are activated in bipolar mode.

[0059] In some embodiments, an outer sheath, such as any of the sheaths described above, may be provided on the energy supply assembly 510, particularly on the sharp distal tip 1504 of the first energy supply member 1500, to protect the scope and / or anatomical passages through which the energy supply assembly 510 passes as it advances to the target site. In some embodiments, the first insulating member 2500 positioned on the first energy supply member 1500 and / or the second insulating member 4500 positioned on the second energy supply member 3500 may be joined to the respective lower energy supply members, for example, to increase buckling strength, as described above with respect to an example of an embodiment of the energy supply assembly 510 illustrated in Figures 6A to 6C. However, it may be desirable that each of the elements 1500, 2500, 3500, and 4500 be movable relative to one another, for example, in any of the embodiments described above, for further adjustability of the energy supply assembly 510.

[0060] In some embodiments, it may be desirable that at least one electrode portion of the energy supply assembly of a bipolar energy supply treatment system be adjustable, in addition to having the same or substantially the same external dimensions (e.g., diameter) as the other electrode portion. According to various principles of this disclosure, an example of an adjustable bipolar energy supply assembly 610 having electrodes of the same or substantially the same external dimensions (e.g., diameter) is shown in Figures 9A and 9B. Similar to the example embodiment of the energy supply assembly 510 shown in Figures 8A and 8B, the first (distal) energy supply member 1600 and the second (proximal) energy supply member 3600 in the example embodiment of the energy supply assembly 610 shown in Figures 9A and 9B have substantially the same external dimensions (e.g., diameter). Various elements of the energy supply assembly 610 illustrated in Figures 9A and 9B are indicated by the same reference numerals as in Figures 8A and 8B plus 100 to indicate similar or identical structures or features, and it should be understood that redundant descriptions are generally omitted for brevity. However, unlike the energy supply assembly 510 illustrated in Figures 8A and 8B, the first electrode portion 1610 (defined by the first energy supply member 1600) and the second electrode portion 3610 (defined by the second energy supply member 3600) are maintained in a state of being spaced apart by an insulating spacer member 2610. More specifically, the insulating spacer member 2610 maintains the energy supply assembly 610 as a bipolar energy supply assembly by maintaining the first electrode portion 1610 in a state of being spaced apart from the second electrode portion 3610. Furthermore, in some embodiments, the outer diameter of the insulating spacer member 2610 is substantially the same as that of the first electrode portion 1610 and / or the second electrode portion 3610. In particular, the first energy supply member 1600 has an elongated body 1602 with a shoulder portion 1606, the shoulder portion 1606 transitions the elongated body 1602 from the first outer diameter 1610D of the electrode portion 1610 to a smaller second outer diameter 1620D of the proximal portion 1620 of the first energy supply member 1600, which extends into (and is insulated by the first insulating member 2600) and has a reduced diameter where a step is formed.Such a reduction in the diameter of the first energy supply member 1600 allows the second energy supply member 3600 to have an outer diameter 3600D that is substantially the same as the outer diameter 3610D of the first electrode portion 1610, while enabling it to extend over the first energy supply member 1600 and the first insulating member 2600. Furthermore, the outer diameter 2610D of the insulating spacer member 2610, positioned between the shoulder portion 1606 and the distal end 3602d of the elongated body 3602 of the second energy supply member 3600, is substantially the same as the outer diameter 3610D of the first electrode portion 1610. Accordingly, similar to the example embodiment of the energy supply assembly 110' shown in Figure 3, the example embodiment of the energy supply assembly 610 shown in Figures 9A and 9B allows for smoother tissue puncture by the sharp distal tip 1604 of the elongated body 1602 of the energy supply member, and subsequently facilitates the insertion of the first electrode portion 1610 and the second electrode portion 3610 into the tissue at the target site.

[0061] To enable the adjustability of the bipolar energy supply assembly 610 shown in Figures 9A and 9B, the second insulating member 4600 positioned on the second energy supply member 3600 may be in the form of an insulating sheath that is slidable relative to the second energy supply member 3600. The second insulating member 4600 may be advanced distally or retracted proximal to the second energy supply member 3600 to change the exposed effective length of the proximal electrode formed by the second energy supply member 3600, thereby adjusting the length of the ablation zone. In some embodiments, the second insulating member 2460 is a thin insulating sheath, such as one made from a polyimide tube or other insulating material, with a thickness of approximately 0.0005 inches (0.0127 mm) to approximately 0.005 inches (0.127 mm), depending on the material and dielectric requirements. In some embodiments, an outer sheath, such as any of the sheaths described above, may be provided over the energy supply assembly 610, particularly over the sharp distal tip 1604 of the first energy supply member 1600, to protect the scope and / or anatomical passages through which the energy supply assembly 610 passes as it advances to the target site.

[0062] In some embodiments, it may be desirable to adjust not only the proximal electrode portion of an adjustable bipolar energy supply assembly but also the distal electrode portion of an adjustable bipolar energy supply assembly, and it may be desirable that both electrode portions have substantially the same outer diameter. In one embodiment of the energy supply assembly 710 shown in Figures 10A, 10B, and 10C, both the first electrode portion 1710 formed by the first energy supply member 1700 and the second electrode portion 3710 formed by the second energy supply member 3700 are adjustable. In addition, similar to the energy supply assembly 610 in Figures 9A and 9B, the first electrode portion 1710 and the second electrode portion 3710 have substantially the same outer diameter. For convenience, the various elements of the energy supply assembly 710 shown in Figures 10A, 10B, 10C, and 10D are indicated by the same reference numerals as in Figures 9A and 9B plus 100 to represent similar or identical structures or features, and redundant descriptions are generally omitted for brevity.

[0063] As can be seen from the cross-sectional views in Figures 10A and 10B, in one embodiment of the energy supply assembly 710, the first energy supply member 1700 is positioned within the first insulating member 2700 so as to be insulated from the second energy supply member 3700, the first electrode portion 1710 is separated and insulated from the second electrode portion 3710 by the insulating spacer member 2710, and the second insulating member 4700 is slidably positioned on both the first energy supply member 1700 and the second energy supply member 3700 to adjust both the first electrode portion 1710 and the second electrode portion 3710. Similar to the embodiment shown in Figures 9A and 9B, the insulating spacer member 2710 may have an outer diameter 2710D substantially equal to the first outer diameter 1710D of the first electrode portion 1710 of the first energy supply member 1700. Furthermore, the first energy supply member 1700 may form a step at the shoulder portion 1706 along the proximal portion 1720 of the first energy supply member 1700 to a reduced second outer diameter 1720D. Such a reduction in diameter allows the second insulating member 2700 and the second energy supply member 3700 to be positioned on the proximal portion 1720 of the reduced diameter of the first energy supply member 1700, while allowing the outer diameter 3700D of the second energy supply member 3700 (and the second electrode portion 3710 defined by the second energy supply member 3700) to be substantially equal to the outer diameter 1710D of the first electrode portion 1710.

[0064] As can be more readily understood in the front view of the energy supply assembly 710 illustrated in Figure 10C, a window 4705 is formed in the second insulating member 4700, through which a portion of the second electrode portion 3710 is exposed. A leg 4707 along the window 4705 holds the distal insulating portion 4710 of the second insulating member 4700 over at least a portion of the first electrode portion 1710. In some cases, two legs 4707 are provided to form two windows in the circumferential range of the second insulating member 4700. Alternatively, up to about 150° of the circumference of the second insulating member 4700 may be removed, thereby leaving a single leg 4707 with an extension of about 30° along the circumference of the second insulating member 4700, which can hold each section of the second insulating member 4700 on both axial sides of the window 4705 in place. The second insulating member 4700 is positioned on both the first energy supply member 1700 and the second energy supply member 3700, partially covering / insulating both members 1700 and 3700 while exposing their respective sections, thereby functioning as electrodes 1710 and 3710 of the energy supply assembly 710 (spaced apart by insulating spacer members 2710). The distal advancement and proximal retraction of the second insulating member 4700 simultaneously adjust the exposed portions 1710 and 3710 of the energy supply members 1700 and 3700. The second insulating member 4700 may be made of a polyimide tube or other insulating material and may be a relatively thin-walled sheath (e.g., about 0.0005 inches (0.0127 mm) to about 0.010 inches (0.254 mm) thick, depending on the material and dielectric requirements) that is in close contact with the energy supply members 1700, 3700 (e.g., in direct contact but still slidable). Similar to the example of the energy supply assembly 610 in the embodiment shown in Figures 9A and 9B, an outer sheath, such as any of the sheaths described above, may be provided on the energy supply assembly 710, particularly on the sharp distal tip 1704 of the first energy supply member 1700, to protect the scope and / or anatomical passages that the energy supply assembly 710 passes through as it advances to the target site.

[0065] It should be understood that each of the energy supply assemblies described above provides various structures, devices, systems, assemblies, and methods for providing energy-based therapy, along with the delivery of therapeutic substances through the lumen of the energy supply member and / or the aspiration and removal of substances from a target site through the lumen of the energy supply member. In some embodiments, the devices, systems, assemblies, and methods described above allow for the adjustment of the energy supply structure, device, system, and / or assembly to change the characteristics of the energy therapy being delivered. It should be understood that the devices, systems, assemblies, and methods disclosed herein may be delivered endoscopically or percutaneously and may be used within other maneuverable lumen access devices.

[0066] It will 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 particular element, structure, or feature illustrated. Other examples of ways of implementing the disclosed principles can be imagined by those skilled in the art who have read this Disclosure. It will be apparent to those skilled in the art that modifications can be applied to the disclosed devices, systems, and / or methods, and / or the order of steps of the methods described herein, without departing from the concepts, spirit, and scope of the Disclosure. It will be understood that various features described in relation to one embodiment can generally be applied to other embodiments, whether expressly indicated or not. The various features described below 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.

[0067] The foregoing description has broad applications and is presented for illustrative and explanatory purposes only; it is not intended to limit the disclosure to one or more forms disclosed herein. It will be understood that various additions, modifications, and substitutions can be made to the embodiments disclosed herein without departing from the concepts, spirit, and scope of the disclosure. In particular, it will be apparent to those skilled in the art that the principles of the disclosure can be embodied in other forms, structures, arrangements, proportions, and using other elements, materials, and components without departing from its concepts, technical ideas, scope, or characteristics. For example, various features of the disclosure are grouped together into one or more aspects, embodiments, or configurations for the purpose of streamlining the disclosure. However, it should be understood that various features of a particular aspect, embodiment, or configuration of the disclosure may be combined in alternative aspects, embodiments, or configurations. While the disclosure is presented with respect to embodiments, it should be understood that various distinct features of the subject matter do not all need to be present to achieve at least some of the desired characteristics 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 numerous modifications, or modifications to the structure, arrangement, proportions, materials, components, etc., used in the implementation of this disclosure, without departing from the principles, technical ideas, or scope of this disclosure, or particularly suited 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 modified, and the size or dimensions of an element may be modified. Similarly, while an operation or 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 or actions or procedures should be performed. In addition, other forms of implementation are within the scope of the following claims. In some cases, the operations described in the claims may be performed in a different order, and the desired result may still be achieved.Accordingly, the embodiments currently disclosed should be considered in all respects to be illustrative and not limiting, and the scope of the claimed subject matter is indicated by the appended claims and is not limited to the foregoing description or to any specific embodiment or configuration described or illustrated herein. In consideration of the foregoing, individual features of any embodiment may be used, either separately or in combination with features of that embodiment or any other embodiment, and the scope of the subject matter is indicated by the appended claims and is not limited to the foregoing description.

[0068] In the foregoing description and the following claims, it will be understood that: The terms “at least one,” “one or more,” and “and / or” as used herein are open-ended expressions that are both conjunctive and disjunctive in their function. Terms such as “a,” “an,” “the,” “first,” and “second” do not exclude plurals. For example, the term “a” or “an” entity, as used herein, refers to one or more of those entities. Thus, the terms “a” (or “an”), “one or more,” and “at least one” can be used interchangeably herein. As used herein and in the appended claims, the term “or” is used generally to include “and / or,” unless the content explicitly states otherwise. As used herein, the conjunction "and" includes each of the structures, components, features, etc. thus combined unless the context explicitly indicates otherwise, and the conjunction "or" includes one or the other of the structures, components, features, etc. thus combined, either alone or in any combination and number, unless the context explicitly indicates otherwise. All directional references (e.g., proximal, distal, top, bottom, upward, downward, left, right, lateral, longitudinal, front, rear, top, bottom, up, down, vertical, horizontal, radial, axial, clockwise, counterclockwise, etc.) 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 location, orientation, or use of this disclosure. References to connections (e.g., attached, combined, 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. Therefore, references to connections do not necessarily imply that two elements are directly connected or have a fixed relationship with one another. References to identifications (e.g., primary, secondary, first, second, third, fourth, etc.) are not intended to imply importance or priority, but are used to distinguish one feature from another.

[0069] The following claims are incorporated by reference into 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 “contained” do not exclude the existence of other elements, components, features, groups, areas, integers, steps, operations, etc. In addition, individual features may be included in different claims, but they may be advantageously combined, and inclusion in different claims does not mean that the combination of features is not feasible and / or advantageous. In addition, a singular reference does not exclude plurals. Reference numerals in the claims are provided merely as examples for clarity and should never be construed as limiting the claims.

Claims

1. An energy supply assembly, A first energy supply member having a sharp distal tip configured to puncture tissue, the first energy supply member having a lumen defined through the first energy supply member and having a distal opening adjacent to the sharp distal tip, the lumen being for delivering a substance distally through the lumen and discharging it from the distal opening of the lumen, and / or drawing a substance into the distal opening of the lumen and drawing it proximal through the lumen, The first insulating member extends over the first energy supply member and has a distal end, An energy supply assembly wherein the first electrode portion of the energy supply assembly is defined along the first energy supply member between the sharp distal tip of the first energy supply member and the distal end of the first insulating member.

2. The energy supply assembly according to claim 1, wherein the first electrode portion is adjustable by moving the first insulating member relative to the first energy supply member.

3. The energy supply assembly according to claim 1 or 2, wherein the first electrode portion and the first insulating member have substantially the same outer diameter.

4. A second energy supply member is disposed on the first insulating member and has a distal end, The present invention further comprises a second insulating member extending over the second energy supply member and having a distal end, The energy supply assembly according to any one of claims 1 to 3, wherein the second electrode portion of the energy supply assembly is defined along the second energy supply member between the distal end of the second energy supply member and the distal end of the second insulating member.

5. The energy supply assembly according to claim 4, wherein at least one of the first energy supply member, the first insulating member, the second energy supply member, or the second insulating member is movable relative to another of the first energy supply member, the first insulating member, the second energy supply member, or the second insulating member in order to adjust at least one of the first electrode portion or the second electrode portion.

6. The energy supply assembly according to any one of claims 1 to 5, wherein the first insulating member is movable relative to the first energy supply member for adjusting the first electrode portion.

7. The energy supply assembly according to any one of claims 4 to 6, wherein the second energy supply member is movable relative to the first insulating member.

8. The energy supply assembly according to any one of claims 4 to 7, wherein the second insulating member is movable relative to the second energy supply member.

9. The energy supply assembly according to any one of claims 4 to 8, wherein the first energy supply member and the first insulating member are fixed to each other, and the second energy supply member and the second insulating member are fixed to each other.

10. The energy supply assembly according to any one of claims 4 to 11, wherein the second energy supply member is distally advanceable so as to move the distal end of the second energy supply member distal to the distal end of the first energy supply member, thereby covering the sharp distal tip of the first energy supply member.

11. The energy supply assembly according to any one of claims 4 to 10, wherein the first electrode portion and the second electrode portion have substantially the same outer diameter.

12. The energy supply assembly according to any one of claims 4 to 12, wherein a window is formed in the second insulating member for exposing the variable length of the second electrode portion, and the distal end of the second insulating member is movable over the first electrode portion to expose the variable length of the first electrode portion.

13. An energy supply treatment system, An energy supply assembly, A first energy supply member having a sharp distal tip configured to puncture tissue, the first energy supply member having a lumen defined through the first energy supply member and having a distal opening adjacent to the sharp distal tip, the lumen being for delivering a substance distally through the lumen and discharging it from the distal opening of the lumen, and / or drawing a substance into the distal opening of the lumen and drawing it proximal through the lumen, The first insulating member extends over the first energy supply member and has a distal end, Here, the first electrode portion of the energy supply assembly is defined along the first energy supply member between the sharp distal tip of the first energy supply member and the distal end of the first insulating member, and the energy supply assembly A handle, wherein the energy supply assembly extends distally from the handle, It is operably connected to the first insulating member and has a first control portion for adjusting the position of the first insulating member relative to the first energy supply member, and An energy supply treatment system comprising: a handle operably connected to an energy supply source and configured to supply energy to the first energy supply member.

14. A sheath extending distally from the handle, wherein the first energy supply member and the first insulating member extend distally from the handle through the sheath, The energy supply treatment system according to claim 13, further comprising: a second control unit operably connected to the first energy supply member for adjusting the position of the first energy supply member relative to the sheath.

15. A second energy supply member is disposed on the first insulating member and has a distal end, A second insulating member extending over the second energy supply member and having a distal end, The device comprises a third control unit which is operably connected to the second insulating member and adjusts the position of the second insulating member relative to the second energy supply member, The energy supply treatment system according to claim 13 or 14, wherein the second electrode portion of the energy supply assembly is defined along the second energy supply member between the distal end of the second energy supply member and the distal end of the second insulating member.

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