Adjustable needle electrodes for medical procedures and related systems and methods

Abstract

A bipolar or monopolar adjustable energy delivery assembly. The assembly is configured for transluminal (e.g., endoscopic) delivery within a patient. The first energy delivery member defines a first electrode portion made of an electrically conductive material so that energy may be delivered to the first energy delivery member to create an energy field along the first electrode portion for application to a target site within a patient. The first energy delivery member may define a lumen therethrough that allows material to be delivered distally therethrough to a target site and / or allows material to be aspirated therethrough from the target site proximally. Optionally, the second energy delivery member and the second insulating member form a second electrode portion. Optionally, one or both of the electrode portions may be adjustable. In addition or alternatively, the first electrode portion and the second electrode portion are adjustable relative to each other.

Description

Cross-reference to related applications

[0001] This application claims the benefit of priority to U.S. Provisional Patent Application No. 63 / 524,999, filed July 5, 2023, the entire disclosure of which is incorporated herein by reference for all purposes. Technical Field

[0002] This disclosure generally relates to the field of medical devices, components, systems, and methods for applying energy (e.g., for therapeutic purposes) to a patient. More specifically, this disclosure relates to the field of medical devices, components, systems, and methods for applying electrical energy (e.g., therapeutic electrical pulses) to a patient. Even more specifically, this disclosure relates to various devices, components, systems, and methods for electroporation therapy. Furthermore, this disclosure specifically relates to adjustable-length medical treatment devices, components, systems, and related methods for applying energy (e.g., electrical energy for electroporation). Background Technology

[0003] Various devices, components, and systems exist for energy-based medical treatments or therapies. Currently, bipolar devices (with two electrodes) can be inserted percutaneously or endoscopically into a patient. Once positioned within a target site (e.g., a tumor), the device is activated, for example, by generating an electric field between and / or around the device's two electrodes, to perform various therapeutic procedures. For example, energy can be applied to perform radiofrequency ablation (RFA), electroporation, and / or irreversible electroporation (IRE) as a means of treating various conditions and / or diseases by destroying and / or altering the properties of biological cellular material. The irreversible electroporation energy applied by the device creates pores in the cell membrane near the device. The electric field disrupts the intracellular homeostasis, thereby killing the cells. Radiofrequency ablation, on the other hand, causes thermal coagulation of the tissue.

[0004] Compared to monopolar devices with a single active electrode positioned on the patient's skin and a return ground pad, bipolar electroporation devices typically generate less muscle contraction. However, compared to monopolar devices, bipolar devices may have a smaller ablation volume, are more prone to arcing between electrodes, are more complex, and require multiple electrodes and insulation layers between electrodes to accommodate small-diameter needles. In contrast, monopolar devices are simpler in characteristics, can form a larger ablation volume, have a lower risk of arcing, and allow space for other features, structures, or devices (such as increased insulation thickness). Thicker insulation in monopolar devices can further improve dielectric strength, enhance electrical safety, and allow for use at higher voltages to achieve a larger ablation volume.

[0005] Adjustable-length electrodes (monopolar or bipolar) offer several advantages, such as ensuring close contact between the ablation volume and the target site (e.g., tumor volume), achieving complete ablation of the tumor volume, and helping to avoid ablation of adjacent non-target tissues, such as healthy tissues (e.g., pancreatic tissue, gastrointestinal wall, etc.) and / or blood vessels. It is in view of these and other relevant considerations that the improved embodiment of the present invention is practical. Summary of the Invention

[0006] This summary presents, in a simplified form, some of the concepts described in detail below in the specific embodiments. This summary is not intended to define key or essential features of the claimed subject matter, nor is it intended to assist in determining the scope of protection of the claimed subject matter. Those skilled in the art will understand that various aspects and features of this disclosure may be advantageously used alone in some cases, and in other cases, in combination with other aspects and features of this disclosure, whether or not they are described in this summary. The inclusion or exclusion of elements, components, etc., in this summary does not constitute a limitation on the scope of protection of the claimed subject matter.

[0007] According to various principles of this disclosure, an energy delivery assembly includes: a first energy delivery member having a sharp distal tip and a lumen, the sharp distal tip being configured to pierce tissue, the lumen being defined through the first energy delivery member and having a distal opening adjacent to the sharp distal tip for delivering material distally through the lumen and exiting from the distal opening of the lumen, and / or for aspirating material into the distal opening of the lumen and proximally through the lumen; and a first insulating member extending on the first energy delivery member and having a distal end. In some aspects, a first electrode portion of the energy delivery assembly is defined along the first energy delivery member between the sharp distal tip of the first energy delivery member and the distal end of the first insulating member.

[0008] In some aspects, the first electrode portion can be adjusted by moving the first insulating member relative to the first energy delivery member.

[0009] In some respects, the outer diameter of the first electrode portion is substantially the same as that of the first insulating member.

[0010] In some aspects, the energy delivery assembly further includes: a second energy delivery member located on the first insulating member and having a distal end; and a second insulating member extending on the second energy delivery member and having a distal end. In some aspects, a second electrode portion of the energy delivery assembly is defined along the second energy delivery member between the distal end of the second energy delivery member and the distal end of the second insulating member. In some aspects, at least one of the first energy delivery member, the first insulating member, the second energy delivery member, or the second insulating member is movable relative to the other of the first energy delivery member, the first insulating member, the second energy delivery member, or the second insulating member to adjust at least one of the first electrode portion or the second electrode portion. In some aspects, the first insulating member is movable relative to the first energy delivery member to adjust the first electrode portion. In some aspects, the second energy delivery member is movable relative to the first insulating member. In some aspects, the second insulating member is movable relative to the second energy delivery member. In some aspects, the second energy delivery member is movable relative to the first insulating member. In some aspects, the second insulating member is movable relative to the second energy delivery member. In some aspects, a first energy delivery member and a first insulating member are fixed relative to each other, and a second energy delivery member and a second insulating member are fixed relative to each other. In some aspects, the second energy delivery member is distally advanceable such that its distal end moves to a position distal to the distal end of the first energy delivery member to cover the sharp distal tip of the first energy delivery member. In some aspects, the outer diameters of the first electrode portion and the second electrode portion are substantially the same. In some aspects, the second insulating member is movable relative to the second energy delivery member. In some aspects, a window is defined in the second insulating member to expose different lengths of the second electrode portion, and the distal end of the second insulating member is movable over the first electrode portion to expose different lengths of the first electrode portion.

[0011] According to various principles of this disclosure, an energy delivery therapy system includes an energy delivery assembly comprising: a first energy delivery member having a sharp distal tip and a lumen, the sharp distal tip being configured to pierce tissue, the lumen being defined through the first energy delivery member and having a distal opening adjacent to the sharp distal tip for delivering material distally through the lumen and exiting from the distal opening of the lumen, and / or for aspirating material into the distal opening of the lumen and proximally through the lumen; and a first insulating member extending on the first energy delivery member and having a distal end. In some aspects, a first electrode portion of the energy delivery assembly is defined along the first energy delivery member between the sharp distal tip of the first energy delivery member and the distal end of the first insulating member. The energy delivery therapy system also includes a handle from which the energy delivery assembly extends distally. In some aspects, the handle includes a first control portion operatively connected to the first insulating member to adjust the position of the first insulating member relative to the first energy delivery member; and the handle is configured to be operatively connected to an energy source to supply energy to the first energy delivery member.

[0012] In some aspects, the energy delivery therapy system further includes: a sheath extending distally from the handle; a first energy delivery member and a first insulating member extending distally from the handle through the sheath; and a second control unit operatively connected to the first energy delivery member to adjust its position relative to the sheath.

[0013] In some aspects, the energy delivery therapy system further includes: a second energy delivery member located on the first insulating member and having a distal end; a second insulating member extending on the second energy delivery member and having a distal end; and a third control unit operatively connected to the second insulating member to adjust its position relative to the second energy delivery member. In some aspects, a second electrode portion of the energy delivery assembly is defined along the second energy delivery member between the distal end of the second energy delivery member and the distal end of the second insulating member.

[0014] According to various principles of this disclosure, a method for treating a target site within a human patient includes: delivering energy to a first energy delivery member, the first energy delivery member being covered by a first insulating member to define a first electrode portion at a distal end of the first energy delivery member; and delivering material to the target site through a lumen defined by the first energy delivery member. In some aspects, delivering material includes at least one of delivering material distally to the target site through the lumen or aspirating material proximally from the target site through the lumen.

[0015] In some aspects, the method also includes adjusting the length of the first electrode portion.

[0016] These and other features and advantages of this disclosure will become apparent from the detailed description below, and the scope of protection of the claimed invention is set forth in the appended claims. Although this disclosure is presented below in the form of multiple aspects or embodiments, it should be understood that each aspect may be claimed individually or in combination with aspects and features of that embodiment or any other embodiment. Attached Figure Description

[0017] Non-limiting embodiments of this disclosure are described by way of example in conjunction with the accompanying drawings, which are schematic views and not drawn to scale. The drawings are provided for illustrative purposes only, and the dimensions, positions, order, and relative sizes reflected in the drawings may vary. For example, the device may be enlarged to clearly show details, but its actual design needs to adapt to structures such as delivery catheters or the working channels of endoscopes, and therefore needs to be scaled down. In the drawings, identical, nearly identical, or equivalent elements are generally denoted by the same reference numerals, and similar elements are denoted by similar reference numerals increased by 100; repetitive descriptions are omitted. For clarity and brevity, not all elements are labeled in every drawing, and not all elements of every embodiment are illustrated; unnecessary illustrations may be omitted as long as those skilled in the art can understand this disclosure.

[0018] The specific embodiments will be easier to understand by referring to the accompanying drawings, in which the same reference numerals denote the same elements, as follows:

[0019] Figure 1 An elevation view of an example embodiment of an energy delivery therapy system formed according to various aspects of this disclosure;

[0020] Figure 1A for Figure 1 An enlarged view of detailed region 1A shows a device formed according to various principles of this disclosure and applicable to... Figure 1 Further details of an example of an embodiment of the energy delivery component of the energy delivery therapy system shown;

[0021] Figure 2 For along Figure 1A Cross-sectional view of line II-II;

[0022] Figure 3 To and Figure 2 A similar cross-sectional view shows an example of another embodiment of the energy delivery assembly;

[0023] Figure 4A An elevation view of an embodiment of another energy delivery therapy system formed according to various aspects of this disclosure, which is in a first configuration corresponding to a first configuration of its energy delivery components;

[0024] Figure 4B for Figure 4AThe elevation view of an embodiment of the energy delivery therapy system shown is in a second configuration corresponding to a second configuration of its energy delivery components;

[0025] Figure 5 This is an example of an embodiment of an adjustable bipolar energy delivery assembly formed according to various principles of the present disclosure, wherein the internal / first / far-end energy delivery member is in elevation view and the insulating member and the external / second / near-end energy delivery member are in cross-sectional view;

[0026] Figure 6A A cross-sectional view of an example embodiment of an adjustable bipolar energy delivery assembly, wherein the first energy delivery member is in elevation view and is covered by a second energy delivery member in cross-sectional view;

[0027] Figure 6B for Figure 6A An adjustable bipolar energy delivery assembly, wherein a first energy delivery member extends distally to a second energy delivery member and enters the target area;

[0028] Figure 6C for Figure 6A and Figure 6B An adjustable bipolar energy delivery assembly, wherein the second energy delivery component is advanced to the target location;

[0029] Figure 7A An elevation view of an example embodiment of an energy delivery therapy system formed according to various aspects of this disclosure, the system being configured to regulate Figure 6A An embodiment of the energy delivery assembly shown;

[0030] Figure 7B for Figure 7A The elevation view of the energy delivery therapy system shown is located in the position corresponding to Figure 6B In the configuration of the energy transfer component shown;

[0031] Figure 7C for Figure 7A The elevation view of the energy delivery therapy system shown is located in the position corresponding to Figure 6C In the configuration of the energy transfer component shown;

[0032] Figure 8A A cross-sectional view of an example embodiment of an adjustable bipolar energy delivery assembly formed according to the various principles of this disclosure, which is in a unipolar configuration;

[0033] Figure 8B for Figure 8A An adjustable bipolar energy delivery component, which is in a bipolar configuration;

[0034] Figure 9AA cross-sectional view of an example embodiment of an adjustable bipolar energy delivery assembly formed according to various principles of the present disclosure, wherein the proximal energy delivery member is in a first configuration;

[0035] Figure 9B for Figure 9A An adjustable bipolar energy delivery assembly, wherein the proximal energy delivery component is in a second configuration;

[0036] Figure 10A A cross-sectional view of an example embodiment of an adjustable bipolar energy delivery assembly formed according to various principles of the present disclosure, wherein the energy delivery member is in a first configuration;

[0037] Figure 10B for Figure 10A A bipolar adjustable energy delivery component, wherein the energy delivery component is in a second configuration;

[0038] Figure 10C for Figure 10A Elevation view of the bipolar adjustable energy delivery component;

[0039] Figure 10D for Figure 10C Elevation view of the bipolar adjustable energy delivery component. Detailed Implementation

[0040] The following detailed description should be read in conjunction with the accompanying drawings, which depict exemplary embodiments. It should be understood that this disclosure is not limited to the specific embodiments described, as variations are possible. All apparatuses, systems, and methods discussed herein are examples of apparatuses and / or systems and / or methods implemented according to one or more principles of this disclosure. Each example in the embodiments is for illustration only and is not the only way to implement these principles, but merely an exemplary representation. Therefore, references to elements, structures, or features in the drawings should be understood as references to examples of embodiments of this disclosure and should not limit this disclosure to the specific elements, structures, or features shown. Those skilled in the art will, upon reading this disclosure, conceive of other exemplary ways of implementing the disclosed principles. In fact, it will be apparent to those skilled in the art that various modifications and variations can be made to this disclosure without departing from the scope or spirit of the subject matter. For example, a feature shown or described in one embodiment can be combined with another embodiment to obtain yet another embodiment. Therefore, this subject matter is intended to cover such modifications and variations that fall within the scope of the appended claims and their equivalents.

[0041] It should be understood that the description of this disclosure in this application has varying degrees of detail. In some cases, details that need not be repeated to enable those skilled in the art to understand this disclosure, or details that would make other details difficult to understand, have been omitted. The terminology used herein is for describing particular embodiments only and is not intended to be limiting beyond the scope of the appended claims. Unless otherwise defined, the technical terms used herein should be understood as having the meaning commonly understood by those skilled in the art to which this disclosure pertains. Based on the content of this disclosure, all the apparatuses and / or methods disclosed and claimed herein can be made and implemented without excessive experimentation.

[0042] As understood herein, “correspondence” is intended to indicate a relationship between components, parts, elements, etc., which are configured to interact or have other intended associations. In this document, “proximal” refers to the direction or position closest to the user (medical professionals, clinicians, technicians, operators, physicians, etc.; these terms are used interchangeably in this document without limitation, including automatic control systems, etc.), for example, when using the device (such as introducing the device into a patient, or during implantation, positioning, or delivery), and / or the direction or position closest to the delivery device; “distal” refers to the direction or position furthest from the user, for example, when using the device (such as introducing the device into a patient, or during implantation, positioning, or delivery), and / or the position closest to the treatment device. “Longitudinal” refers to extending along the longer or larger dimension of the element. “Longitudinal axis” extends along the longitudinal range of the element, but it is not necessarily a straight line, and it does not necessarily maintain a fixed shape if the element flexes or bends; “axial” generally refers to the direction along the longitudinal axis. However, it should be understood that descriptions of axial or longitudinal movement of the above-described system or its elements are not strictly limited to axial and / or longitudinal movement along the longitudinal axis or central axis of the referenced element. "Center" refers to a point that at least roughly bisects the center point and / or is approximately equidistant from the periphery or boundary; "central axis," for an opening, refers to a straight line that at least roughly bisects the center point of the opening, extending longitudinally along the length of the opening when the opening includes, for example, a tubular element, a strut, a channel, a chamber, or a hole. In this document, "lumen," "channel," "hole," or "access" is not limited to a circular cross-section. In this document, "free end" of an element refers to the end of the element that no longer extends outward. It should be understood that, unless otherwise stated, the terms "at the end," "on the end," "near the end," or "along the end" are used interchangeably in this document without limitation, and these terms are intended to indicate approximate relative spatial relationships rather than precisely defined locations. For convenience, the terms treatment, therapy, diagnosis, surgery, etc., and their various grammatical forms may be used interchangeably in this document without limitation, and the use of one term does not exclude the other terms unless explicitly stated. Furthermore, it should be understood that the terms treatment site, target site, location, etc., are used interchangeably in this document without limitation. Finally, when referring to a location or part, it is intended to include that location or part and / or approximately in its vicinity (e.g., along, adjacent, near, etc.).

[0043] As used herein, the term "ablation" generally refers to the direct or indirect removal of cells by supplying energy within an electric field, and may include cell removal achieved through loss of cell function, cell lysis, coagulation, protein denaturation, necrosis, apoptosis, and / or irreversible electroporation. "Ablation" can also refer to the formation of damage (lesion) through ablation. Furthermore, the terms "undesired tissue," "target cells," "lesion tissue," "lesion cells," "tumor," and "cell cluster" used herein may refer to cells that have been or will be partially or completely removed by ablation, and are not intended to limit the scope of application of any component, system, device, or method described herein. For example, these terms include the ablation of lesion cells and certain surrounding cells, even if there is no clear indication that these surrounding cells are lesioned. Ablation performed by the components, systems, devices, or methods described herein may target cells within tissue or cells surrounding biological lumens (e.g., blood vessels, catheters, or channel regions). Based on the various principles of this disclosure, the devices, components, systems, and methods disclosed herein may be configured to perform ablation via electroporation and / or irreversible electroporation (IRE).

[0044] According to various principles of this disclosure, an energy delivery therapy system includes an energy delivery assembly having a first energy delivery member having a conductive elongated body defining an electrode portion along its length. More specifically, the conductive elongated body may be made of a conductive material, such as medical-grade stainless steel, platinum, gold, nitinol, cobalt-chromium alloy, such as MP35N nickel-cobalt alloy, or other alloys, or a material plated with a conductive material. An insulating member is positioned around a proximal portion of the first energy delivery member to insulate the proximal portion of the first energy delivery member (thereby preventing energy from being delivered to the patient along the insulating portion of the first energy delivery member). The distal portion of the first energy delivery member not located within / covered by the insulating member defines a first electrode portion of the energy delivery assembly. The first electrode portion can be considered to be defined as extending between the distal end of the first energy delivery member and the distal end of the insulating member. An insulating layer may or may not be provided around other portions of the energy delivery assembly. According to various principles of this disclosure, a lumen may define a passage through a first energy delivery member, and the lumen may be configured to deliver material (e.g., therapeutic material) distally through it and exit from its distal end (e.g., adjacent to / located at the distal end of the first energy delivery member) to a target site. Alternatively or additionally, the lumen may be configured to aspirate or extract material from the target site into the distal end of the lumen (e.g., adjacent to or located at the distal end of the first energy delivery member), and enter proximally and pass through the lumen. In some aspects, the distal end of the first energy delivery member is configured as a sharp distal end, which may be configured to puncture and / or perforate tissue, such as tissue at the target site. Therefore, in some aspects, the first energy delivery member of the energy delivery assembly formed according to the various principles of this disclosure not only forms the electrode portion of the energy delivery assembly, but can also serve as a material delivery device with a lumen capable of delivering materials (e.g., therapeutic / healing materials, irrigation materials, chemotherapeutic drugs, immunogenic reagents, gel isolation materials, embolization materials, etc.) and / or other devices (e.g., guidewires, reference markers, sensing devices (e.g., pounds per square inch (psi), pH, temperature, etc.), imaging devices, etc.) to the target site; and / or aspirating or removing materials (liquids, tissue samples, etc.) from the target site.

[0045] Energy delivery components can be delivered via elongated tubular structures (e.g., delivery sheaths, catheters, endoscope working channels, etc.) inserted into the patient's body (e.g., through natural anatomical passages or openings into body cavities), or percutaneously, via puncture, or even surgically. The energy delivery component of the energy delivery assembly can be coupled to an energy source to power the electrode portion, thereby applying an electric current to biological tissue. The energy source can be operated to generate an electric field between this electrode portion and another electrode portion (e.g., an electrode portion coupled to the energy source and of opposite polarity, such as a loop electrode or ground electrode).

[0046] The energy delivery assembly formed according to the various principles of this disclosure can be a monopolar device inserted into a patient's body, with its return electrode or ground electrode located outside the patient's body (as opposed to being located inside the patient's body, such as on the patient's epidermis). Alternatively, the energy delivery assembly can be a bipolar device, with at least two electrodes configured to be disposed at or near undesired tissue (e.g., target cells, target site, treatment site, diseased tissue, diseased cells, tumor, cell cluster) within a tissue treatment area (e.g., target region or target site) inside the patient's body. Depending on the desired application scenario, such as the diagnostic or therapeutic procedure to be performed, a particular electrode can be configured as an anode or cathode, or at least one of a plurality of electrodes can be configured as an anode and at least another electrode as a cathode.

[0047] Once the energy delivery assembly, formed according to the various principles of this disclosure, is positioned at or near a non-desired tissue, an excitation potential can be applied to its electrode portions to generate an electric field, exposing the tissue at the target site to this electric field. The excitation potential (and the generated 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 irreversible electroporation (IRE), high-frequency IRE, nanosecond pulses, and / or ablation waveforms. The energy source generates an electric field with the desired therapeutic characteristics at the target site. For example, the generated electric field may have suitable characteristic waveform outputs in terms of voltage, impedance, frequency, amplitude, pulse width, inter-pulse delay, number of pulses per train, number of pulse trains, and polarity. Current flows between the electrodes and through the tissue, its magnitude proportional to the potential (e.g., voltage) applied to the electrodes. The current provided by the energy source can deliver a pulse sequence to the target site. For example, the energy source may provide various waveforms in the form of one or more pulse sequences, depending on the intended application requirements.

[0048] According to the various principles of this disclosure, the electrodes of the energy delivery assembly (electrodes of a unipolar energy delivery assembly, or one or both electrodes of a bipolar energy delivery assembly) formed according to the various principles of this disclosure are adjustable to change the electric field generated along their electrode portions. For example, various characteristics of the electrodes and the energy field generated around them can be adjusted according to the characteristics of the target site (e.g., the size of the tumor to be treated and / or variations in the target site, etc.), the characteristics of the target site being determined by pre-diagnostic examination, computed tomography (CT), magnetic resonance imaging (MRI), endoscopy and / or ultrasound, or other imaging techniques known to those skilled in the art, typically completed before the energy delivery therapy system delivers the energy to the target site. Adjustment can also be made again based on ultrasound or other imaging techniques after the energy delivery therapy system has delivered the energy to the target site. According to the various principles of this disclosure, the length of the electrode portion of the energy delivery assembly is adjustable, such as to adjust the length and / or volume of the energy field generated around it when energy is applied to it. Optionally, the voltage can also be adjusted to further modulate the energy field (e.g., primarily adjusting the radial diameter of the energy field).

[0049] According to various principles of this disclosure, a unipolar energy delivery assembly includes a first energy delivery member. The energy delivery member optionally has a lumen passing through it, such that the first energy delivery member can not only deliver energy to a target site for treatment / healing, but also deliver material to and / or remove material from the target site. According to further principles of this disclosure, the first energy delivery member may have a sharp distal tip, and optionally, the distal region of the energy delivery member is configured to facilitate smooth penetration / entry of the energy delivery member into the target site. Furthermore or alternatively, according to various further principles of this disclosure, the energy delivery member of the energy delivery assembly is adjustable, such as in terms of length.

[0050] In some aspects, the energy delivery assembly formed according to the various principles of this disclosure is a bipolar energy delivery assembly. According to the various principles of this disclosure, the bipolar energy delivery assembly includes a first energy delivery member and a second energy delivery member. According to the various principles of this disclosure, the first energy delivery member optionally has a lumen defining a passage therethrough, as described in the relevant description of the unipolar energy delivery assembly above. In some aspects, one or both of the first and second energy delivery members are adjustable and / or adjustable relative to each other. Furthermore or alternatively, the distal portion of the bipolar energy delivery assembly is configured to facilitate smooth penetration / entry of the energy delivery member into the target site.

[0051] The energy delivery components, devices, systems, and methods described herein can be used in electroporation, irreversible electroporation (IRE), and / or electroporation permeation techniques to apply an external electric field (potential) to the cell membrane to significantly increase the permeability of the cytoplasmic membrane, thereby enhancing the efficiency of cellular uptake of therapeutic materials. Optionally, the energy applied to the cell can alter cell membrane properties (e.g., porosity), for example, producing irreversible changes that lead to cell death (e.g., through apoptosis and / or necrosis). Such techniques can be advantageously used to administer therapeutic / healing energy without raising the temperature of surrounding tissue to a level that could cause permanent damage to surrounding tissue, supporting structures, and / or the local vascular system. Therefore, applying irreversible electroporation (IRE) pulses to cells can be an effective way to ablate large volumes of undesirable tissue with little or no thermal damage to surrounding healthy tissue. This device can also be used for radiofrequency ablation, which achieves thermal coagulation of tissue.

[0052] Various embodiments of electrode devices, components, systems, and related methods will now be described with reference to the examples shown in the accompanying drawings. References to "one embodiment," "an embodiment," "some embodiments," "other embodiments," etc., in this specification indicate that the embodiment may include one or more specific features, structures, concepts, and / or characteristics of the principles of this disclosure. However, such references do not imply that all embodiments include that specific feature, structure, concept, and / or characteristic, nor do they imply that a particular embodiment includes all features, structures, concepts, and / or characteristics. Some embodiments may include one or more such features, structures, concepts, and / or characteristics in various combinations. It should be understood that one or more features, structures, concepts, and / or characteristics described with reference to one embodiment can be combined with one or more features, structures, concepts, and / or characteristics of any other embodiment provided herein. That is, any features, structures, concepts, and / or characteristics described herein can be combined to form hybrid embodiments, and such hybrid embodiments are all within the scope of protection of this disclosure. Furthermore, references to "one embodiment," "an embodiment," "some embodiments," "other embodiments," etc., in different locations in the specification do not all refer to the same embodiment, and individual or alternative embodiments are not necessarily mutually exclusive with other embodiments. It should also be understood that the various features, structures, concepts, and / or characteristics of the disclosed embodiments are independent and separate from each other, and may be used or presented individually or in various combinations thereof to form alternative embodiments, all of which are considered part of this disclosure. Therefore, this disclosure is not limited to the embodiments specifically described herein, as describing all the numerous possible combinations and sub-combinations of features, structures, concepts, and / or characteristics would be cumbersome, and the examples of embodiments disclosed herein are not intended to limit the broader scope of this disclosure. It should be understood that the various dimensions provided herein are merely exemplary, and those skilled in the art can readily determine suitable ranges of standard deviations and the resulting acceptable deviations, all of which are covered within the scope of this disclosure and any related claims. The following description is merely an illustrative example of embodiments and is not intended to limit the broader scope of this disclosure.

[0053] In the accompanying drawings, it should be understood that the same features are identified by the same reference numerals, and for the sake of brevity and convenience, descriptions of the same features are generally not repeated without limitation. For clarity, not all parts with the same reference numerals are labeled. It should be understood that in the following description, similar elements or parts in the various illustrated embodiments are generally labeled with the same reference numerals incremented by multiples of 100, and redundant descriptions are generally omitted for brevity. Furthermore, some features in one embodiment may be common in different embodiments, and when they appear in different embodiments, they are not necessarily labeled separately.

[0054] Now refer to the attached diagram, Figure 1 An example of one embodiment of an energy delivery therapy system 100 is shown. An energy delivery assembly 110 and an optional sheath 120 (which may extend over the energy delivery assembly 110) extend from a distal end 100d of the energy delivery therapy system 100. The energy delivery assembly 110 includes an energy delivery member 1000 and an insulating member 2000 extending over at least a proximal portion of the energy delivery member 1000. The energy delivery member 1000 and its insulating member 2000 are generally configured to selectively extend distally from the distal end 120d of the sheath 120 to protect passages through which the energy delivery assembly 110 extends (e.g., the working passage of an endoscope, a human lumen, etc.) from damage by the sharp distal tip 1000d of the energy delivery member 1000 (described further in detail below), and can be retracted proximally to expose at least a distal portion of the energy delivery assembly 110. Optionally, an energy source is coupled to the proximal end 100p of the energy delivery therapy system 100 via a power connector 130. The power connector 130 may include a plug and / or cables and / or other wiring configured to connect to an energy source (via power supply cable 132), which is of a type known to those skilled in the art and can be selected in a known manner depending on the type of energy to be applied by the energy delivery therapy system 100.

[0055] The energy delivery therapy system 100 optionally includes a handle 140 operatively connected to the energy delivery assembly 110 to control elements of the energy delivery assembly 110, such as controlling the position of the energy delivery member 1000. The handle 140 may also be operatively connected to a sheath 120 to control the position of the sheath 120 relative to the energy delivery assembly 110, in a manner known to those skilled in the art. In some embodiments, the handle 140 includes a first control portion 142 operatively connected to the sheath 120, for example, connected to the sheath 120 and configured to adjust / control the position of the sheath 120 relative to a delivery device through which the energy delivery assembly 110 and the sheath 120 are advanced to the treatment site. It should be understood that the delivery device can be any desired delivery device, such as a delivery sheath or endoscope, having a lumen or working channel through it, sized to allow the energy delivery assembly 110 and the sheath 120 to pass through it; this disclosure is not limiting in this regard. The handle 140 includes a second control unit 144 operatively connected to the energy delivery assembly 110, such as being connected to the energy delivery assembly 110 and configured to adjust / control the position of the distal end 110d of the energy delivery assembly 110 relative to the sheath 120. For example, once the distal end 120d of the sheath 120 is positioned at or near the treatment site (e.g., by operation or control of the first control unit 142), the energy delivery assembly 110 can be extended distally beyond the distal end 120d of the sheath 120 by operation or control of the second control unit 144.

[0056] Based on the various principles of this disclosure, the energy delivery assembly 110 is an elongated, flexible assembly capable of navigating within a patient's body, such as through natural openings and / or through elongated tubular structures inserted into the patient's body. More specifically, the energy delivery member 1000 of the energy delivery assembly 110 may be an elongated structure with sufficient flexibility to be inserted into the body through cavities (e.g., endoscopic insertion, unlike percutaneous insertion) and navigate through potentially tortuous paths within the body, or at least be able to bend or turn within or along the natural nonlinear anatomy of the body. Additionally or alternatively, the energy delivery member 1000 has sufficient resilience to prevent breakage during navigation. Those skilled in the art will understand that suitable length, flexibility, resilience, and / or other properties / characteristics of the energy delivery member 1000 can be determined based on the various principles of this disclosure, taking into account its material, size, shape, configuration, and / or specifications; this disclosure is not necessarily limited to specific parameters. In some aspects, the size, shape, configuration and / or specifications of one or more of its components, elements, members, etc., formed according to the various principles of this disclosure are adjustable (such as relative to other components, elements, members, etc. of the energy delivery assembly 110), as will be described in detail below.

[0057] In some aspects, the energy delivery component 1000 of the energy delivery assembly 110 is a cannula (solid or with a lumen passing through it), needle, tip, or tissue puncture device / electrode capable of easily puncturing tissue / organ / tumor masses, with or without core sampling capability. The energy delivery component 1000 can be any of a variety of needle types, including but not limited to lancets, Franzen needles, cannula needles, Sprott needles, pencil-tip needles, Chiba needles, Turner needles, Madajag needles, Green needles, Mengenie needles, and Wescott needles. In some aspects, the energy delivery component 1000 may employ a fine-needle aspiration (FNA) or fine-needle biopsy (FNB) tip configuration. In some aspects, the energy delivery component 1000 has selected flexibility to accommodate the ease-of-use requirements of various delivery devices (such as those configured for transcavitary delivery), and / or the ability to retract and / or deploy the energy delivery component 1000 to desired locations in convoluted anatomical structures without unacceptable shape fixation. In some respects, the size of the energy delivery component 1000 can be as small as a 34-ga needle, as large as a 6-ga needle, and includes various increments in between. The length of the energy delivery component 1000 can be any suitable length that allows it to be inserted into the patient and reach the desired target site.

[0058] Based on the various principles of this disclosure, the needle can not only have a sharp distal end and / or define a lumen therethrough, but can also be energized to deliver energy to the treatment site for therapeutic, diagnostic, or other purposes. Voltage, current (e.g., waveform, pulse pattern, size and nature of the energy pulse train, frequency, etc.), power, and other parameters can be adjusted according to the needs or instructions of the specific treatment, treatment, or operation being performed; this disclosure is not limited to these details. A power connector 130 is electrically connected to the energy delivery member 1000 to provide the desired form of energy to the energy delivery member 1000. Furthermore, the energy delivery member 1000 is made of 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 a material plated with a conductive material), which is capable of contacting and conducting electricity with tissue, thereby delivering sufficient energy to ablate tissue and / or applying sufficient energy to achieve tissue ablation, electroporation, and / or irreversible electroporation in the electric field of the energy delivery member 1000.

[0059] like Figure 1A The detailed view shown in the image (corresponding to) Figure 1 (Details of section 1A) An example of an embodiment of the energy delivery member 1000 formed according to various principles of the present disclosure has an elongated body 1002 with a distal end 1002d, which optionally includes a sharp distal tip 1004. It should be understood that the distal end 1002d of the elongated body 1002 of the energy delivery member may coincide with the distal end 1000d of the energy delivery member 1000, and the references to distal end 1000d or distal end 1002d are interchangeable herein and are not limiting unless explicitly stated otherwise. Further according to various principles of the present disclosure, a lumen 1003 is defined through the energy delivery member 1000, which terminates at a distal opening adjacent to / located at the sharp distal tip 1004 of the elongated body 1002.

[0060] In addition or alternatively, Figure 1A The example of the embodiment of the insulating member 2000 shown and formed according to various principles of the present disclosure has an elongated body 2002 defining a cavity 2003 through which the energy transport member 1000 passes. It should be understood that the distal end 2002d of the elongated body 2002 of the insulating member may coincide with the distal end 2000d of the insulating member 2000. The terms distal end 2000d and distal end 2002d are used interchangeably herein and have no limiting meaning unless explicitly stated otherwise.

[0061] like Figure 1A As shown, and along Figure 1A Intercepted from the middle II-II line Figure 2As shown in the cross-sectional view, the distal portion of the energy transport member 1000 extends distally beyond the distal end 2002d of the elongated body 2002 of the insulating member 2000 to define the electrode portion 1010 of the energy transport 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 transport member 1000 to be located 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, the distal end 2002d being located on the proximal portion of the elongated body 1002 of the energy transport member 1000. The insulating member 2000 is made of an insulating material (e.g., polymer extrusion, polymer heat shrink tubing, non-metallic braided shaft, composite shaft, etc.), so only the portion of the energy delivery member 1000 extending beyond the distal end 2002d of the elongated body 2002 of the insulating member 2000 serves as an electrode (wherein the proximal portion of the elongated body 1002 of the energy delivery member 1000 located within the insulating member 2000 is insulated / shielded and therefore does not apply / transmit energy to the patient). Therefore, the distance between the distal end 1002d of the elongated body 1002 of the energy delivery 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 delivery assembly 110. The proximal portion 1020 of the elongated body 1002 of the energy delivery member proximal to the electrode portion 1010 is insulated by the insulating member 2000, and can therefore be regarded as only acting as an insulating needle. It has no other electrotherapy function except for conducting / delivering energy to the electrode portion 1010 at the distal end 1002d of the elongated body 1002 of the energy delivery member.

[0062] It is understandable that, based on the various principles of this disclosure, Figure 2 The illustrated embodiment of the energy delivery assembly 110 provides a unique structure for delivering therapeutic energy to a patient. This structure can be considered a monopolar needle, such as a monopolar irreversible electroporation needle. The energy delivery assembly 110 not only has electrode regions (also referred to as probes) for providing or delivering energy, but may also have lumens for delivering materials (e.g., drugs, treatment agents, therapeutic agents, or irrigation fluids such as saline) or for aspirating materials (e.g., tissue samples, fluids, or other materials that may need to be removed from the treatment site). For example, the distal end 1002d of the elongated body 1002 of the energy delivery member can be inserted into diseased tissue, and agents such as chemotherapy drugs can be applied before, after, or during treatment (e.g., in conjunction with energy treatment applied by the electrode portion 1010 of the energy delivery assembly 110). Since irreversible electroporation (IRE) creates pores on cell membranes, the delivery of therapeutic substances via electroporation electrodes (such as through the energy delivery assembly 110 of this disclosure) can synergistically improve the efficacy of chemotherapy drugs by making them more readily absorbed by cells.

[0063] exist Figure 2 In the example of the illustrated embodiment, the outer diameter of the energy transmission member 1000 may be substantially constant, wherein the outer diameter of the insulating member 2000 formed thereon or otherwise located thereon is larger than the outer diameter of the energy transmission member 1000. Alternatively, Figure 3 An example embodiment of the energy delivery assembly 110' shown has an energy delivery member 1100 whose proximal portion 1120 forms a stepped structure at a shoulder 1106 relative to an electrode portion 1110 defined along the distal portion of the energy delivery member 1100. In some aspects, the outer diameter 1120D of the proximal portion 1120 of the energy delivery member 1100 is reduced relative to the outer diameter 1110D of the electrode portion 1110 defined at the distal end 1102d of the elongated body 1102 of the energy delivery member. This reduced outer diameter 1120D provides space around the elongated body 1102 of the energy delivery member for an insulating member 2100 to be fitted thereon (wherein the proximal portion 1120 of the energy delivery member 1100 is embedded within a lumen 2103 defined through the insulating member 2100), such as Figure 3 As shown. In some embodiments, the outer diameter 2100D of the insulating member 2100 may be substantially equal to (and thus substantially flush with) the outer diameter 1110D of the electrode portion 1110. This configuration facilitates smoother tissue penetration by the sharp distal tip 1104 of the elongated body 1102 of the energy delivery member. It should be understood that... Figure 3 The components of the energy transfer assembly 110' shown adopt the same... Figure 2 Identical reference numerals are used in the accompanying drawings, with the reference numerals incremented by 100 to indicate similar or identical structures or features. For brevity, redundant descriptions are typically omitted. Furthermore, Figure 3 Examples of embodiments of the energy delivery assembly 110' shown can be compared with Figure 1 The components of the illustrated embodiment of the energy delivery therapy system 100 are used in combination, as will be understood by those skilled in the art.

[0064] Based on the various principles of this disclosure, various modifications can be made to the basic structure, characteristics, features, and performance of the energy delivery components and / or insulating components of the energy therapy assembly of this disclosure. For example, the number of energy delivery components and / or insulating components; the positioning of the energy delivery components and / or insulating components relative to each other; the connection method of the energy delivery components and / or insulating components; the size, shape, configuration, and / or specifications of the energy delivery components and / or insulating components; and other structures, characteristics, features, and performance of the energy delivery components and / or insulating components can all be changed to form an energy therapy assembly based on the various principles of this disclosure, which will be described below in conjunction with various other accompanying drawings of this disclosure.

[0065] It may be desirable to adjust various characteristics of the energy delivery portion (e.g., the electrode portion) of the monopolar needle to accommodate variations in the size, shape, etc., of the treatment site. For example, a longer electrode typically results in a longer ablation volume, the need for which can be determined based on the nature and characteristics of the treatment site. Furthermore, or alternatively, the applied voltage may be increased to further increase the radial diameter of the ablation zone. Based on various principles of this disclosure, in some aspects, the size, shape, configuration, and / or specifications of the energy delivery assembly described herein are adjustable.

[0066] Figure 4A and Figure 4B Examples of embodiments of an energy delivery therapy system 200, comprising an adjustable (e.g., length-adjustable) unipolar energy delivery component 210, are shown, formed according to various principles of this disclosure. It should be understood that... Figure 4A and Figure 4B The various components of the example embodiment of the energy delivery therapy system 200 shown employ, with Figure 1 and Figure 2 The same reference numerals are used to indicate similar or identical structures or features. For the sake of brevity, redundant descriptions are usually omitted.

[0067] and Figure 2 Similar to the example shown in the embodiment, the electrode portion 1210 of the energy transport member 1200 is defined by a portion of the energy transport member 1200 extending distally to the distal end 2200d of the insulating member 2200 (located between the energy transport member end 1200d / 1202d and the insulating member end 2200d / 2202d). However, in contrast... Figure 4A and Figure 4B As can be understood from the energy delivery assembly 210 extending from the distal end 200d of the energy delivery therapy system 200, the energy delivery member 1200 is movable relative to the insulating member 2200 (e.g., sliding proximally or distally out of the insulating member 2200) to change its exposed length, the length of which forms the electrode portion 1210. More specifically, in Figure 4A In the example of the illustrated embodiment, the distal end 2200d of the insulating member 2200 is separated from the distal end 1202d of the energy transmission member 1200 by a first distance (the distal end 2200d of the insulating member 2200 is located proximal to the distal end 1202d of the energy transmission member 1200). Furthermore, in Figure 4BIn the example of the illustrated embodiment, the distal end 2200d of the insulating member 2200 (after relative movement between the energy transport member 1100 and the insulating member 2200) is separated from the distal end 1202d of the energy transport member 1200 by a second distance (the distal end 2200d of the insulating member 2200 is located proximal to the distal end 1202d of the energy transport member 1200), and this second distance is greater than the first distance. Therefore, the electrode portion 1210 is in Figure 4A It has a first length corresponding to the first distance, and in Figure 4B The electrode portion 1210 has a second length corresponding to a second distance, and the second length is greater than the first length. The length of the electrode portion 1210 can be varied by the relative movement of the energy delivery member 1200 and the insulating member 2300, such as retracting the insulating member 2300 proximally relative to the energy delivery member 1200, and / or extending the energy delivery member 1200 distally relative to the insulating member 2200. It should be understood that the distance between the distal end 1200d of the energy delivery member 1200 (and the distal end 1202d of its elongated body 1202) and the distal end 1200d of the insulating member 2200 (and the distal end 2202d of its elongated body 2202), and the length of the electrode portion 1210 thus defined between these ends 1200d, 2200d, can be adjusted relatively infinitely or in preset incremental steps during the relative movement (e.g., sliding) of the energy delivery member 1200 and the insulating member 2200. It is understood that the energy transmission component 1200 and the insulation component 2200 can be configured as described above. Figure 1 The embodiment of the sheath 120 shown is illustrated in an example manner in which the sheath 220 is pushed out to the distal side or retracted into the sheath 220 to the proximal side. Those skilled in the art may refer to its contents for further applicable descriptions.

[0068] In some aspects, for ease of adjustment Figure 4A and Figure 4B An example of an embodiment of the energy delivery therapy system 200 shown has an energy delivery assembly 210, with a handle 240 operably connected to one or more elements of the energy delivery assembly 210 to control its movement. More specifically, according to various principles of this disclosure, Figure 4A and Figure 4B An example embodiment of the energy delivery therapy system 200 shown includes a handle 240 comprising a first control unit 242, a second control unit 244, and a third control unit 246. The first control unit 242 is operatively connected to the sheath 220 and is compatible with the aforementioned... Figure 1The first control unit 142 is substantially similar (e.g., in form and / or function), and for the sake of brevity and without limitation, reference is made to its related description. The second control unit 244 is operatively connected to the energy delivery member 1200 of the energy delivery assembly 110, such as being connected to the energy delivery member 1200 and configured to control the position of the distal end 1200d of the energy delivery member 1200 relative to the sheath 220. The second control unit 244 may be associated with the aforementioned... Figure 1 The second control unit 144 is substantially similar (e.g., in form and / or function), and for the sake of brevity and without limitation, reference is made to its related description. Figure 4A and Figure 4B In an example embodiment of the handle 240 shown, a third control portion 246 is operatively connected to an insulating member 2200, such as being connected to the insulating member 2200 and configured to control the position of the distal end 2202d of the insulating member 2200 relative to the distal end 1200d of the energy delivery member 1200. In some aspects, the insulating member 2200 may slide relative to the energy delivery member 1200, such as when the third control portion 246 slides or performs other movements. For example, the third control portion 246 may be moved proximally (e.g., from...). Figure 4A Move to the indicated position Figure 4B The position shown allows the insulating member 2200 to retract proximally relative to the energy delivery member 1200, thereby increasing the length of the electrode portion 1210 of the energy delivery member 1200. Optionally, to reduce friction between the insulating member 2200 and the energy delivery member 1200, the insulating member 2200 may include an inner tubular element made of a material that facilitates movement relative to the energy delivery member 1200. For example, in some embodiments, the insulating member 2200 may be made of a metal thiocyanate tube coated with an insulating material, such as a polymer insulating material (e.g., an extrusion, heat shrink tubing, etc.). Other configurations are also within the scope and spirit of this disclosure, and this disclosure does not limit them.

[0069] Based on the principles of this disclosure, the aforementioned principles can be applied to form a bipolar rather than unipolar adjustable energy delivery component 310, such as a bipolar needle probe, etc. Figure 5 As shown. For example, Figure 5 An example embodiment of the adjustable bipolar energy delivery assembly 310 shown has a first energy delivery member 1300 on which a first insulating member 2300 is located. The first energy delivery member 1300 and the first insulating member 2300 are as described above. Figure 4A and Figure 4B The energy delivery member 1200 and the insulating member 2200 described in the example embodiment of the adjustable unipolar energy delivery assembly 210 are substantially similar. Therefore, for the sake of brevity and without constituting limitation, Figure 5 The same or similar elements shown are used in Figure 4A and Figure 4B The same but with an additional 100 reference numerals are used in the attached figures, and for the sake of brevity, redundant descriptions are omitted (refer to the above-provided figures applicable to...). Figure 5 (Description of the same or similar elements in the text). However, with Figure 4A and Figure 4B The adjustable energy delivery component 210 shown is different. Figure 5 The adjustable energy delivery assembly 310 shown has a second electrode, which can also be insulated like the first electrode. More specifically, Figure 5 The adjustable bipolar energy delivery assembly 310 shown includes a second energy delivery member 3300 and a second insulating member 4300 extending at least on the proximal portion of the second energy delivery elongated member 3300. The second energy delivery member 3300 may be a conductive tubular member through which the first energy delivery member 1300 and the first insulating member 2300 can be advanced distally and / or retracted proximally. In some embodiments, the second energy delivery member 3300 is a conductive thiopanle, such as a metal (e.g., medical-grade / biocompatible 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) thiopanle, the forming material of which may be the same as, similar to, or different from the forming material of the first energy delivery member 1300. The second insulating member 4300 may be similar to, substantially the same as, or different from the first insulating member 2300, differing only in size (e.g., the second insulating member 4300 may be larger than the first insulating member 2300 to allow the first energy delivery member 1300, the first insulating member 2300, and the second energy delivery member 3300 to extend through it). While the first insulating member 2300 and the second insulating member 4300 may be substantially the same, this is not mandatory, as each insulating member 2300, 4300 may have slightly different uses and requirements for the proper and safe operation of the energy delivery assembly 310. In some respects, the second energy delivery member 3300 provides support for the insulating member 4300 positioned around it. It should be understood that in practical applications, the second energy delivery member 3300 should have a complete insulating layer between itself and the first energy delivery member 1300, such as that provided by the first insulating member 2300 (whether or not it is adjustable), and an insulating layer such as that provided by the second insulating member 4300 (whether or not it is adjustable). Figure 4A and Figure 4B Similar to the energy delivery assembly 210 shown, the sheath (not shown) can be... Figure 5 The energy transmission components 1300, 3300 and insulating components 2300, 4300 of the energy transmission assembly 310 shown extend therefrom. This sheath is substantially the same in nature and characteristics as the sheath 120 described above, and therefore, reference can be made to the above description for applications suitable for use with… Figure 5 The sheath used in conjunction with the energy delivery assembly 310 shown.

[0070] Figure 5 The example energy delivery components 1300, 3300 of the illustrated embodiment of the adjustable bipolar energy delivery assembly 310 provide needle-like electrodes / probes that have similar benefits to the monopolar energy delivery assemblies 110, 110', 210 described above, enabling simultaneous energy-based therapy and / or material sampling and / or aspiration. Furthermore, similar to the adjustable monopolar energy delivery assembly 210 described above, Figure 5 The adjustable bipolar energy delivery assembly 310 shown allows for adjustment of its energy delivery components (e.g., length adjustment). However, Figure 5 The energy delivery assembly 310 shown includes two energy delivery members 1300 and 3300, which can adjust not only the first energy delivery member 1300 but also optionally the second energy delivery member 3300. Furthermore, Figure 5 The energy delivery assembly 310 shown can also adjust the insulating member 2300 between the first energy delivery member 1300 and the second energy delivery member 3300 to adjust the distance between the two electrodes of the bipolar needle-shaped probe / electrode of the energy delivery assembly 310, thereby adjusting the effective surface area of ​​the energy delivery assembly 310. Specifically, with Figure 4A and Figure 4B Similar to the adjustable unipolar energy delivery assembly 210 shown, the first energy delivery member 1300 of the energy delivery assembly 310 defines a first electrode portion 1310, which is defined between the distal end 1300d of the first energy delivery member 1300 (e.g., the distal end 1302d of the elongated body 1302 of the first energy delivery 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). Further with... Figure 4A and Figure 4B Similar to the adjustable unipolar energy delivery assembly 210 shown, the first energy delivery member 1300 and the first insulating member 2300 are movable relative to each other to adjust the length of the electrode portion 1310 of the energy delivery member 1300, which is defined between the energy delivery member end 1300d / 1302d and the insulating member end 2200d / 2202d.

[0071] Figure 5The second energy delivery member 3300 of an example embodiment of the adjustable bipolar energy delivery assembly 310 shown defines a second electrode portion 3310 of the energy delivery assembly 310, which is defined between the distal end 3300d of the second energy delivery member 3300 (e.g., the distal end 3302d of the elongated body 3302 of the second energy delivery member 3300) and the distal end 4300d of the second insulating member 4300 (e.g., the distal end 4302d of the elongated body 4302 of the second insulating member 4300). Similar to the first energy delivery member 1300, the second energy delivery member 3300 defines a second electrode portion 3310, which is defined between the distal end 3300d of the second energy delivery member 3300 (e.g., the distal end 3302d of the elongated body 3302 of the second energy delivery member 3300) and the distal end 4300d of the second insulating member 4300 (e.g., the distal end 4302d of the elongated body 4302 of the second insulating member 4300). Furthermore, similar to the first energy delivery member 1300 and the first insulating member 2300, the second energy delivery member 3300 and the second insulating member 4300 are movable relative to each other to adjust the length of the second electrode portion 3310 of the second energy delivery member 3300 defined between the distal ends 3300d / 3302d of the second energy delivery member and the distal ends 4200d / 4202d of the second insulating member.

[0072] During use, energy (e.g., electric current) is delivered to the energy delivery assembly 310 to be transmitted between and between the first electrode portion 1310 and the second electrode portion 3310 of the energy delivery assembly 310. It is understood that one of the first electrode portion 1310 and the second electrode portion 3310 acts as the anode of the bipolar energy delivery assembly 310, and the other of the first electrode portion 1310 and the second electrode portion 3310 acts as the cathode of the bipolar energy delivery assembly 310. Any one or each of the first energy delivery member 1300, the first insulating member 2300, the second energy delivery member 3300, and the second insulating member 4300 may be movable relative to each other to change the length, distance, etc. of the electrode portions 1310, 3310 and / or the insulating members 2000, 4300 (e.g., changing the distance between the proximal, distal end of the second energy delivery member 3300 and the distal, proximal end of the first energy delivery member 1300 adjacent to the distal end 2300d of the first insulating member 2300), and the associated and other relevant characteristics and performance of the energy delivery assembly 310 as understood by those skilled in the art. Furthermore, any one or each of the first energy delivery member 1300, the first insulating member 2300, the second energy delivery member 3300, and the second insulating member 4300 may be operatively connected to an associated handle member that is movable (e.g., sliding) to retract or axially advance / extend the associated member 1300, 2300, 3300, 4300 operatively connected thereto. The handle and related components described above can be used with Figure 5 An example embodiment of the energy delivery assembly 310 shown is operatively connected.

[0073] Understandably, this is to facilitate navigation within the patient's body. Figure 5 The components 1300, 2300, 3300, and 4300 of the illustrated energy delivery assembly 310 must generally be fine enough to form an overall size and flexibility suitable for navigation, delivery, and use of the energy delivery assembly 310. Furthermore, as previously mentioned, standard fine needle aspiration (FNA) devices have a needle housed within a protective sheath that protects the working channel of the delivery device (e.g., an endoscope) used to deliver the energy delivery assembly and / or protects the patient's tissue from needle tip puncture. For example, as referenced... Figure 1 The energy delivery assembly 110 can be delivered to the target site within the sheath 120, wherein the sharp distal tip 1000d of the energy delivery member 1000 is located proximal to the distal end 120d of the sheath 120. Once the protective sheath has passed through the delivery device and extended beyond its distal end, the FNA needle is ejected from the distal end of the sheath during puncture, and the sheath typically does not enter the tissue. Similar sheaths can be used with... Figure 5 The example of the embodiment of the energy delivery component 310 shown is used in conjunction with this.

[0074] Based on the various principles of this disclosure, such as Figure 6A , Figure 6B and Figure 6C As shown, the adjustable bipolar energy delivery assembly 410 may be formed with a proximal second energy delivery member 3400, which forms a protective sheath for the distal first energy delivery member 1400 (such as a needle in the form of an FNA needle). More specifically, Figure 6A , Figure 6B and Figure 6C An example embodiment of the adjustable bipolar energy delivery assembly 410 shown has a first energy delivery member 1400 having a first insulating member 2400 positioned therearound it. The first energy delivery member 1400 and the first insulating member 2400 are movable relative to each other (e.g., adjusting the length of the electrode portion 1410 of the first energy delivery member 1400, as referenced above). Figure 4A and Figure 4B The illustrated embodiment describes an example of this approach, or the components are fixed to each other and firmly joined together (e.g., to improve stability, column strength, etc., which typically results in a fixed length of the electrode portion 1410). This portion of the energy delivery assembly 410 may be coupled with... Figure 1 and Figure 2 The energy transmission component 1000 and the insulating component 2000 of the energy transmission assembly 110 shown are substantially the same or similar. Therefore, similar or similar elements are indicated by the addition of 100, for the sake of brevity and without limitation. Reference can be made to the above description of... Figure 1 The description of such components is as follows. Optionally, the outer diameter of the distal portion of the electrode forming portion 1410 of the first energy delivery member 1400 may be substantially the same as the outer diameter of the first insulating member 2400, similar to... Figure 3 The example of the embodiment of the energy delivery assembly 110' shown is for the sake of brevity and is not intended to be limiting; further details are available therein.

[0075] exist Figure 6A , Figure 6B and Figure 6C In an example of an embodiment of the energy delivery assembly 410 shown, the second energy delivery member 3400 is formed of a generally tubular member through which the first energy delivery member 1400 and the first insulating member 2400 extend. According to various principles of this disclosure, the second energy delivery member 3400 may be conductive to form the second electrode portion 3410. The second insulating member 4400 may be located on the second energy delivery member 3400 to define the second electrode portion 3410 between the distal end 3400d of the second energy delivery member 3400 (e.g., the distal end 3402d of the elongated body 3402 of the second energy delivery member 3400) and the distal end 4400d of the second insulating member 4400 (e.g., the distal end 4402d of the elongated body 4402 of the second insulating member 4400), such as... Figure 6CAs shown. According to various principles of this disclosure, the second energy delivery member 3400 can be made of a sodium hypochlorite tube, and the second insulating member 2400 can be made of the same material as described above. Figure 5 The described energy delivery assembly 310 is made of a similar insulating material to the second energy delivery member 3300 and the second insulating member 4300. The second energy delivery member 3400 can support the insulating member 4400 surrounding it. However, unlike the second energy delivery member 3400, the second insulating member 4400 may be movable relative to each other, and the second energy delivery member 3400 and the second insulating member 4400 may generally be fixed relative to each other and firmly joined together. Therefore, Figure 6A , Figure 6B and Figure 6C As shown, the proximal electrode of the energy delivery assembly 410, defined by the second energy delivery member 3400 and the second insulating member 4400, has sufficient rigidity to protect the sharp distal tip 1404 of the first energy delivery member 1400, thereby providing an FNA protection structure typically achieved by a separate sheath. Furthermore, the second energy delivery member 3400 and the second insulating member 4400 surrounding and coupled thereto may have better column strength than components that can move relative to each other, because the second insulating member 4400 is mechanically supported by the second energy delivery member 3400. However, it is understood that for further adjustability of the energy delivery assembly 410, it is desirable that each element 1400, 2400, 3400, 4400 of the energy delivery assembly 410 move relative to each other in any of the aforementioned manner.

[0076] During use, the distal electrode, defined by the first energy delivery member 1400 and the first insulating member 2400, can move (e.g., slide) relative to the proximal electrode formed by the second energy delivery member 3400 and the second insulating member 4400. It is understood that the lengths of the respective electrode portions 1410, 3410 of the distal and proximal electrodes can be fixed (since the first insulating member 2400 is fixed relative to the first energy delivery member 1000, and the second insulating member 2400 is fixed relative to the second energy delivery member 4400). However, the distal and proximal electrodes can move relative to each other, for example, by moving the first energy delivery member 1400 distally relative to the second energy delivery member 3400, or by moving the second energy delivery member 3400 proximally relative to the first energy delivery member 1400. The relative movement of the distal and proximal electrodes adjusts the insulation length between the electrode portions 1410, 3410, thereby affecting the overall length of the adjustable bipolar energy delivery assembly 410, for example, affecting the treatment volume of the energy delivery assembly 410.

[0077] Figure 6A , Figure 6B and Figure 6CAn example embodiment of the energy delivery assembly 410 shown can initially deliver energy to a target site T, wherein the sharp distal tip 1404 of the distal electrode defined by the first energy delivery member 1400 is located within the proximal electrode defined by the second energy delivery member 3400 (e.g., retracted proximally), as... Figure 6A As shown. In this configuration, the delivery device (e.g., endoscope) or patient anatomy through which the energy delivery assembly 410 passes can be protected from damage by the sharp distal tip 1404. Once the energy delivery assembly 410 (particularly the distal end 3400d of the second energy delivery member 3400) is positioned at the target site T (e.g., tissue), for example extending distally from the distal end of the delivery device, the distal end 3400d of the second energy delivery member 3400 can contact the target site T, such as... Figure 6A As shown. Subsequently, the sharp distal tip 1404 of the first energy delivery member 1400 may extend distally beyond the second energy delivery member 3400 (e.g., beyond the distal end 3400d of the energy delivery member 3400 and / or the distal end 3402d of its elongated body 3402) to pierce the target site T, such as Figure 6B As shown. At this stage, it is not necessary to advance the second energy delivery member 1400 into the target site T. However, it is understood that advancing the first energy delivery member 1400 into the target site T, by forming an initial puncture / opening within the target site T, facilitates the subsequent advancement of the second energy delivery member 3400 into the target site T. Subsequently, the second energy delivery member 3400 can be advanced into the target site T, as follows: Figure 6C As shown. After the two electrode portions 1410 and 3410 of the energy delivery assembly 410 are positioned as desired relative to the target portion T, the adjustable bipolar energy delivery assembly 410 can be adjusted as needed (as described above) to deliver and / or draw material through the lumen 1403 of the first energy delivery member 1400, and / or deliver energy between and between the first electrode portion 1410 and the second electrode portion 3410.

[0078] Figure 7A , Figure 7B and Figure 7C An example of an embodiment of the handle 440 is shown, which can be used with... Figure 6A , Figure 6B and Figure 6C One or more elements of the energy delivery assembly 410 shown are operatively connected to control the movement of its elements. Figure 1 Examples of embodiments of the handle 140 shown and Figure 4A and Figure 4B The example of the handle 240 shown is similar. Figure 7A , Figure 7B and Figure 7CAn example embodiment of the handle 440 shown has a first control unit 442 operably connected to the sheath 420. The first control unit 442 can be connected to the aforementioned reference... Figure 1 The first control unit 142 described and / or the above reference Figure 4A and Figure 4B The first control unit 242 described is substantially similar (e.g., in form and / or function). Therefore, similar or identical elements are indicated by the addition of similar reference numerals 300, for the sake of brevity and without limitation; reference may be made to the above description of… Figure 1 Description of such components.

[0079] When the first energy transmission component 1400 and the second energy transmission component 2400 are in Figure 6A When in the position shown, the control units 442, 444, 446, and 448 of the handle 440 can be used as follows: Figure 7A As shown. To configure the first energy transmission member 1400 and the second energy transmission member 3400 in... Figure 6B and Figure 6C The distance at the indicated position (where the first energy delivery member 1400 extends from the second energy delivery member 3400) allows the user to adjust and set (e.g., fix in place) the position of the selectable position control element 448 relative to the second control unit 444. To advance the first energy delivery member 1400 of the energy delivery assembly 410 through the target site T (e.g., puncture tissue / cells at the target site T), as... Figure 6B As shown, the user advances the second control unit 444 (operably connected to the first energy delivery member 1400) relative to the first control unit 442 (operably connected to the sheath 420) (e.g., relative to...). Figure 7A (as shown, the position is advanced longitudinally / distally), for example, by sliding the second control unit 444 on the base or shaft 445 extending proximally, such as... Figure 7B As shown. When the second control unit 444 is transferred from... Figure 7A Advance to the position shown Figure 7B In the indicated position, the second control unit 444 also moves distally relative to the third control unit 446 (operably connected to the second energy delivery member 3400), thereby extending the first energy delivery member 1400 distally from the second energy delivery member 3400, such that the distal end 1400d of the first energy delivery member 1400 is located distal to the distal end 3400d of the second energy delivery member 3400, as shown. Figure 6B and Figure 7B As shown. The sharp distal tip 1404 of the first energy delivery member 1400 can extend into the tissue together with the elongated body 1402 of the energy delivery member 1400 and the insulating member 2400 surrounding the energy delivery member 1400, as Figure 6BAs shown. Optionally, the second control unit 444 can be advanced distally (advancing the electrode 1410 into the patient's body) until it reaches the end of the latch or slot in the handle 440 and / or the first control unit 442. If a position control element 448 is present (and is typically fixed relative to the second control unit 444), the distal advancement of the second control unit 444 causes the position control element 448 to be advanced distally toward the third control unit 446 until the position control element 448 abuts against the third control unit 446, as shown. Figure 7B As shown. The second control unit 444 is positioned relative to... Figure 7B Further advance to the position shown, such as Figure 7C As shown, this also causes the position control element 448 to advance, which abuts against the third control unit 446, thereby also advancing the third control unit 446. Thus, the entire energy delivery assembly 410 (including the second energy delivery member 3400 and the surrounding insulating member 4400) is advanced into the tissue, as... Figure 6C As shown. Subsequently, an energy source can be connected to the energy delivery assembly 410 and energy can be delivered to it, for example via a power connector 430 connected to the proximal end 400p of the energy delivery therapy system 400, as referenced above. Figure 1 The energy delivery therapy system 100 shown is configured in this manner.

[0080] Based on the various principles of this disclosure, it is desirable that the electrodes of the energy delivery component of the adjustable bipolar energy delivery therapy system have the same or substantially the same external dimensions (e.g., diameter) to facilitate smoother puncture of tissue at the target site. Figure 8A and Figure 8B In the example of the embodiment of the adjustable bipolar energy delivery assembly 510 shown, the first (distal) energy delivery member 1500 and the second (proximal) energy delivery member 3500 have substantially the same external dimensions (e.g., diameter). As can be employed... Figure 8A The energy delivery assembly 510 configuration shown performs initial tissue puncture; this configuration can be considered a compression structure. This configuration avoids an excessively flexible region between the electrode portion 1510 of the first energy delivery member 1500 and the electrode portion 3510 of the second energy delivery member 3500, thereby avoiding potential interference with puncture due to excessive device flexibility. It is understood that... Figure 8A and Figure 8B The various elements of the example embodiment of the energy delivery assembly 510 shown are... Figures 6A-6C The examples of embodiments of the energy delivery assembly 410 shown have similar elements (except for the relative dimensions of their elements). Therefore, similar or identical elements are indicated by the addition of 100 reference numerals, for the sake of brevity and without limitation, as described above regarding... Figures 6A-6C The description of such components. Furthermore, it can be understood that... Figure 8Aand Figure 8B The energy delivery assembly 510 shown can be used for Figures 7A-7C The energy delivery therapy system 400 shown.

[0081] Understandable, but Figure 8A The configuration shown delivers energy to the energy delivery component 510. Specifically, in Figure 8A In the illustrated configuration, the first (distal) electrode portion 1510 (formed by the first energy delivery member 1500) and the second (proximal) electrode portion 3510 (formed by the second energy delivery member 3500) can contact each other and can be shorted together and activated in a unipolar mode as if they were a single electrode. In the example of the illustrated embodiment, since the outer diameter of the first energy delivery member 1500 is substantially equal to the outer diameter of the second energy delivery member 3500, the first electrode portion 1510 and the second electrode portion 3510 can have the same or substantially the same diameter.

[0082] In some aspects, after the energy delivery assembly 510 is positioned relative to a target site as desired, the first (e.g., distal) energy delivery member 1500 and the second (e.g., proximal) energy delivery member 3500 can be separated (e.g., moved relative to each other). For example, the second energy delivery member 3500 can be moved proximally (e.g., retracted relative to the first energy delivery member 1500), and / or the first energy delivery member 1500 can be further advanced distally relative to the second energy delivery member 3500, separating the first electrode portion 1510 and the second electrode portion 3510 by a distance determined by a medical professional, suitable for treatments / surgeries performed using the energy delivery assembly 510 (e.g., delivering energy to the energy delivery assembly 510 to create an irreversible electroporation (IRE) lesion covering the entire tumor). It is understood that the separation distance between the first electrode portion 1510 and the second electrode portion 3510 can be determined with consideration of avoiding arcing between the electrode portions 1510, 3510 when activated in bipolar mode.

[0083] In some aspects, an outer sheath (such as any of the sheaths described above) may be provided on the energy delivery assembly 510, particularly on the sharp distal tip 1504 of the first energy delivery member 1500, to protect the endoscope and / or anatomical passage through which the energy delivery assembly 510 is advanced to the target site. In some aspects, the first insulating member 2500 located on the first energy delivery member 1500 and / or the second insulating member 4500 located on the second energy delivery member 3500 may be combined with the respective underlying energy delivery member, for example, to improve column strength, as described above. Figures 6A-6CThe description illustrates an example embodiment of the energy delivery assembly 510. However, it may be desirable that, for further adjustability of the energy delivery assembly 510, each element 1500, 2500, 3500, 4500 can be moved relative to each other in any of the aforementioned manner.

[0084] In some aspects, it may be desirable that at least one electrode portion of the energy delivery component of a bipolar energy delivery therapy system, in addition to having the same or substantially the same external dimensions (e.g., diameter) as another electrode portion, is also adjustable. Based on various principles of this disclosure, Figure 9A and Figure 9B An example embodiment of an adjustable bipolar energy delivery assembly 610 is shown, whose electrode portions have the same or substantially the same external dimensions (e.g., diameter). Figure 8A and Figure 8B The example of the energy delivery assembly 510 shown is similar. Figure 9A and Figure 9B The first (distal) energy delivery member 1600 and the second (proximal) energy delivery member 3600 of the embodiment of the energy delivery assembly 610 shown have substantially the same external dimensions (e.g., diameter). It can be understood that... Figure 9A and Figure 9B The various components of the energy transfer assembly 610 shown adopt the same as... Figure 8A and Figure 8B Reference elements that are identical and increased by 100 represent similar or identical structures or features; for the sake of brevity, redundant descriptions are usually omitted. However, with Figure 8A and Figure 8BUnlike the energy delivery assembly 510 shown, the first electrode portion 1610 (defined by the first energy delivery member 1600) and the second electrode portion 3610 (defined by the second energy delivery member 3600) are spaced apart by an insulating spacer 2610. More specifically, the insulating spacer 2610 spaces the first electrode portion 1610 from the second electrode portion 3610 to maintain the energy delivery assembly 610 as a bipolar energy delivery assembly. Furthermore, in some aspects, the outer diameter of the insulating spacer 2610 is substantially the same as the outer diameter of the first electrode portion 1610 and / or the second electrode portion 3610. Specifically, the first energy delivery member 1600 has an elongated body 1602, whose shoulder 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 first energy delivery member 1600, having a stepped diameter-reducing proximal portion 1620 extending within (and insulated by) the first insulating member 2600. This diameter reduction of the first energy delivery member 1600 allows the second energy delivery member 3600 to extend over both the first energy delivery member 1600 and the first insulating member 2600 to have an outer diameter 3600D substantially the same as the outer diameter 3610D of the first electrode portion 1610. Furthermore, the outer diameter 2610D of the insulating spacer 2610 located between the shoulder 1606 and the distal end 3602d of the elongated body 3602 of the second energy delivery member 3600 is substantially the same as the outer diameter 3610D of the first electrode portion 1610. Therefore, similar to Figure 3 An example of an embodiment of the energy delivery assembly 110' shown. Figure 9A and Figure 9B An example of an embodiment of the energy delivery assembly 610 shown allows the sharp distal tip 1604 of the elongated body 1602 of the energy delivery member to more smoothly pierce tissue, followed by the insertion of the first electrode portion 1610 and the second electrode portion 3610 into the tissue at the target site.

[0085] In order to achieve Figure 9A and Figure 9BThe adjustability of the illustrated bipolar energy delivery assembly 610 allows the second insulating member 4600 located on the second energy delivery member 3600 to be in the form of an insulating sheath that can slide relative to the second energy delivery member 3600. The second insulating member 4600 can be advanced distally or retracted proximally relative to the second energy delivery member 3600 to alter the exposure and effective length of the proximal electrode formed by the second energy delivery member 3600, thereby adjusting the length of the ablation zone. In some aspects, the second insulating member 2460 is a thin-walled insulating sheath, for example made of polyimide tubing or other insulating materials, with a thickness ranging from about 0.0005 inches (0.0127 mm) to about 0.005 inches (0.127 mm), depending on material and dielectric requirements. In some aspects, an external sheath (such as any of the sheaths described above) may be provided on the energy delivery assembly 610, particularly on the sharp distal tip 1604 of the first energy delivery member 1600, to protect the endoscope and / or anatomical passage through which the energy delivery assembly 610 is advanced to the target site.

[0086] In some aspects, it is desirable to be able to adjust not only the proximal electrode portion of the adjustable bipolar energy transfer component, but also its distal electrode portion, with the outer diameters of the two electrode portions being substantially the same. Figure 10A , Figure 10B and Figure 10C In the example of the embodiment of the energy delivery assembly 710 shown, both the first electrode portion 1710 formed by the first energy delivery member 1700 and the second electrode portion 3710 formed by the second energy delivery member 3700 are adjustable. Furthermore, with... Figure 9A and Figure 9B Similar to the energy delivery assembly 610, the first electrode portion 1710 and the second electrode portion 3710 have substantially the same outer diameter. For convenience, Figure 10A , Figure 10B , Figure 10C and Figure 10D The various components of the energy transfer assembly 710 shown adopt the same as... Figure 9A and Figure 9B Reference elements that are identical and increase by 100 represent similar or identical structures or features; for the sake of brevity, redundant descriptions are usually omitted.

[0087] In an example of an embodiment of the energy delivery component 710, from Figure 10A and Figure 10BAs can be seen from the cross-sectional view, the first energy transmission member 1700 is located within the first insulating member 2700 to insulate it from the second energy transmission member 3700; the first electrode portion 1710 is separated from and insulated from the second electrode portion 3710 by the insulating spacer 2710; and the second insulating member 4700 is slidably located on the first energy transmission member 1700 and the second energy transmission member 3700 to adjust both the first electrode portion 1710 and the second electrode portion 3710. (As shown in...) Figure 9A and Figure 9B In the example of the illustrated embodiment, the outer diameter 2710D of the insulating spacer 2710 may be substantially equal to the first outer diameter 1710D of the first electrode portion 1710 of the first energy transport member 1700. Furthermore, the first energy transport member 1700 may be stepped at the shoulder 1706 to have a reduced second outer diameter 1720D along the proximal portion 1720 of the first energy transport member 1700. This diameter reduction positions the second insulating member 2700 and the second energy transport member 3700 on the reduced-diameter proximal portion 1720 of the first energy transport member 1700, while simultaneously ensuring that the outer diameter 3700D of the second energy transport member 3700 (and the second electrode portion 3710 defined by the second energy transport member 3700) is substantially equal to the outer diameter 1710D of the first electrode portion 1710.

[0088] from Figure 10CThe elevation view of the energy delivery assembly 710 shown provides a clearer view of the window 4705 formed on the second insulating member 4700 to expose a portion of the second electrode portion 3710. Legs 4707 adjacent to the window 4705 hold at least a portion of the distal insulating portion 4710 of the second insulating member 4700 onto the first electrode portion 1710. In some cases, two legs 4707 may be provided to form two windows around the circumference of the second insulating member 4700. Alternatively, up to approximately 150° of the circumferential portion of the second insulating member 4700 may be removed, leaving only one leg 4707 with a range of approximately 30° around the circumference of the second insulating member 4700 to secure the portions of the second insulating member 4700 located on either side of the window 4705 in place. The second insulating member 4700 is located on both the first energy delivery member 1700 and the second energy delivery member 3700 to partially cover / insulate both members 1700 and 3700 while exposing a portion of their area to serve as electrodes 1710 and 3710 (spaced apart by insulating spacers 2710) of the energy delivery assembly 710. Advancing the second insulating member 4700 distally and retracting it proximally allows for simultaneous adjustment of the exposed portions 1710 and 3710 of the energy delivery members 1700 and 3700. The second insulating member 4700 may be made of polyimide tubing or other insulating material and may be a relatively thin-walled sheath (e.g., about 0.0005 inches (0.0127 mm) thick to about 0.010 inches (0.254 mm) thick, depending on material and dielectric requirements) that is in close contact (e.g., direct contact, but still allows for relative sliding) with the energy delivery members 1700 and 3700. Figure 9A and Figure 9B Similar to the example of the embodiment of the energy delivery assembly 610 shown, an external sheath (such as any of the sheaths described above) may be provided on the energy delivery assembly 710, particularly on the sharp distal tip 1704 of the first energy delivery member 1700, to protect the endoscope and / or anatomical passage through which the energy delivery assembly 710 is advanced to the target site.

[0089] It is understood that each of the above-described energy delivery components provides various structures, devices, systems, components, and methods for providing energy-based therapy while simultaneously delivering therapeutic material through the lumen of the energy delivery component and / or aspirating material from a target site through the lumen of the energy delivery component. In some aspects, the above-described devices, systems, components, and methods allow for adjustment of the energy delivery structure, device, system, and / or component to alter the characteristics of the delivered energy therapy. It is understood that the devices, systems, components, and methods disclosed herein can be delivered endoscopically or percutaneously, and can also be used within other maneuverable cavity access devices.

[0090] It is understood that all structures, apparatuses, systems, components, and methods discussed herein are examples of implementations based on one or more principles of this disclosure and are not the only ways to implement these principles, and are therefore not intended to limit the broader scope of this disclosure. Therefore, references to elements, structures, or features in the drawings should be understood as references to examples of embodiments of this disclosure and should not be construed as limiting this disclosure to the specific elements, structures, or features shown. Other exemplary ways of implementing the disclosed principles will occur to those skilled in the art upon reading this disclosure. It will be apparent to those skilled in the art that various modifications and variations can be made to the disclosed apparatuses, systems, and / or methods, and / or the sequence of method steps described herein, without departing from the concept, spirit, and scope of this disclosure. It is understood that various features described for one embodiment are generally applicable to another embodiment, whether explicitly stated or not. The various features described below can be used alone or in any combination. Therefore, the invention is not limited to the embodiments specifically described herein, and all alternatives and modifications that are apparent to those skilled in the art are considered to fall within the spirit, scope, and concept of this disclosure as defined by the appended claims.

[0091] The foregoing discussion has broad applications and is intended for illustration and description, and is not intended to limit this disclosure to the form disclosed herein. It should be understood that various additions, modifications, and substitutions can be made to the embodiments disclosed herein without departing from the concept, spirit, and scope of this disclosure. Specifically, those skilled in the art will appreciate that the principles of this disclosure can be embodied in other forms, structures, arrangements, proportions, and using other elements, materials, and components without departing from the concept, spirit, scope, or characteristics of this disclosure. For example, various features of this disclosure may be combined in one or more aspects, embodiments, or configurations to simplify the disclosure. However, it should be understood that various features of a particular aspect, embodiment, or configuration of this disclosure may be combined in alternative aspects, embodiments, or configurations. Although this disclosure is presented in the form of embodiments, it should be understood that not all individual technical features of this disclosure need to be simultaneously present to obtain at least some of the intended characteristics and / or beneficial effects of this disclosure; implementing these features individually may also achieve the corresponding effects. Those skilled in the art will understand that this disclosure can be modified in practice in various ways regarding structure, arrangement, proportion, materials, components, etc., to make it particularly suitable for specific environments and operational requirements without departing from the principles, spirit, or scope of this disclosure. For example, an element shown as integrally formed may be formed from multiple parts, or an element shown as multiple parts may be integrally formed; the operation of the element may be reversed or otherwise changed; the size or specifications of the element may be changed. Similarly, although operations, actions, or procedures are described in a particular order, this should not be construed as requiring them to be performed in that particular order, or requiring all operations, actions, or procedures to achieve the desired result. Furthermore, other embodiments also fall within the scope of the appended claims. In some cases, the actions recited in the claims may be performed in a different order and the desired result may still be achieved. Therefore, the embodiments disclosed herein should be considered illustrative rather than restrictive in all respects, and the scope of the claimed subject matter is indicated by the appended claims, not by the specific embodiments or arrangements described above or illustrated herein. In view of this, any individual technical feature in any embodiment may be used alone, claimed alone, or used in combination with features of that embodiment or any other embodiment, and the scope of the subject matter is defined by the appended claims, not by the foregoing description.

[0092] The following should be understood in the foregoing description and the following claims. The phrases “at least one,” “one or more,” and “and / or” as used herein are open-ended expressions, serving both parallel and selective functions. The terms “a,” “an,” “the,” “first,” “second,” etc., do not exclude plural forms. For example, the term “a” or “an” as used herein refers to one or more of that entity. Therefore, the terms “a,” “one or more,” and “at least one” are used interchangeably herein. In this specification and the appended claims, the term “or” is generally used to include the meaning of “and / or” unless the context explicitly states otherwise. The conjunction “and” as used herein includes each of all so-connected structures, components, features, etc., unless the context explicitly indicates otherwise; the conjunction “or” includes one or more of all so-connected structures, components, features, etc., which may be selected individually or in any combination and number, unless the context explicitly indicates otherwise. All directional references (e.g., proximal, distal, up, down, upward, downward, left, right, lateral, longitudinal, front, back, top, bottom, above, below, 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 the areas of related elements from each other, and are not intended to limit the related elements, and in particular, do not limit the location, orientation, or purpose of this disclosure. Connection references (e.g., attachment, link, connection, joint, combination, etc.) should be interpreted broadly and may include intermediate components between sets of elements and relative movement between elements, unless otherwise stated. Therefore, a connection reference does not necessarily mean that two elements are directly connected and fixed to each other. Identification references (e.g., primary, secondary, first, second, third, fourth, etc.) are not intended to indicate importance or priority, but are used to distinguish one feature from another.

[0093] The following claims are incorporated herein by reference, each claim being a separate embodiment of this disclosure. In the claims, the terms "comprising," "including," etc., do not exclude the presence of other elements, components, features, groups, regions, integers, steps, operations, etc. Furthermore, although individual features may be included in different claims, these features may be advantageously combined, and the inclusion of these features in different claims does not imply that such combinations are infeasible and / or unadvantageous. Moreover, singular references do not exclude plural forms. Reference numerals in the claims are provided as clarifying examples only and should not be construed in any way as limiting the scope of the claims.

Claims

1. An energy transmission component, comprising: A first energy delivery member having a sharp distal tip and a lumen, the sharp distal tip being configured to pierce tissue, the lumen being defined to pass through the first energy delivery member and having a distal opening adjacent to the sharp distal tip for delivering material distally through the lumen and exiting from the distal opening of the lumen, and / or for aspirating material into the distal opening of the lumen and proximally through the lumen; as well as A first insulating member extends over the first energy transmission member and has a distal end; The first electrode portion of the energy delivery assembly is defined along the first energy delivery member between the sharp distal tip of the first energy delivery member and the distal end of the first insulating member.

2. The energy transmission component according to claim 1, wherein, The first electrode portion can be adjusted by moving the first insulating member relative to the first energy delivery member.

3. The energy transmission component according to any one of claims 1-2, wherein, The outer diameter of the first electrode portion is substantially the same as that of the first insulating component.

4. The energy transmission assembly according to any one of claims 1-3, further comprising: A second energy delivery component is located on the first insulating component and has a distal end; as well as A second insulating member extends over the second energy transmission member and has a distal end; The second electrode portion of the energy delivery assembly is defined along the second energy delivery member between the distal end of the second energy delivery member and the distal end of the second insulating member.

5. The energy transmission component according to claim 4, wherein, At least one of the first energy delivery member, the first insulating member, the second energy delivery member, or the second insulating member is movable relative to the other of the first energy delivery member, the first insulating member, the second energy delivery member, or the second insulating member to adjust at least one of the first electrode portion or the second electrode portion.

6. The energy transmission assembly according to any one of claims 1-5, wherein, The first insulating member is movable relative to the first energy delivery member to adjust the first electrode portion.

7. The energy transmission component according to any one of claims 4-6, wherein, The second energy transmission component is movable relative to the first insulating component.

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

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

10. The energy transmission assembly according to any one of claims 4-11, wherein, The second energy delivery member can be advanced distally to move its distal end to the distal end of the first energy delivery member to cover the sharp distal tip of the first energy delivery member.

11. The energy transmission assembly according to any one of claims 4-10, wherein, The outer diameters of the first electrode portion and the second electrode portion are substantially the same.

12. The energy transmission assembly according to any one of claims 4-12, wherein, The second insulating member defines a window to expose different lengths of the second electrode portion, and the distal end of the second insulating member is movable over the first electrode portion to expose different lengths of the first electrode portion.

13. An energy delivery therapy system, comprising: Energy delivery components, including: A first energy delivery member having a sharp distal tip and a lumen, the sharp distal tip being configured to pierce tissue, the lumen being defined to pass through the first energy delivery member and having a distal opening adjacent to the sharp distal tip for delivering material distally through the lumen and exiting from the distal opening of the lumen, and / or for aspirating material into the distal opening of the lumen and proximally through the lumen; and A first insulating member extends over the first energy transmission member and has a distal end; Wherein, the first electrode portion of the energy delivery assembly is defined along the first energy delivery member between the sharp distal tip of the first energy delivery member and the distal end of the first insulating member; and The handle, from which the energy delivery assembly extends distally, wherein the handle: It has a first control unit operably connected to the first insulating member to adjust the position of the first insulating member relative to the first energy transmission member; and It is configured to be operatively connected to an energy source to supply energy to the first energy delivery component.

14. The energy delivery therapy system according to claim 13, further comprising: A sheath extending distally from the handle, wherein the first energy delivery member and the first insulating member extend distally from the handle through the sheath; as well as A second control unit is operatively connected to the first energy delivery member to adjust its position relative to the sheath.

15. The energy delivery therapy system according to any one of claims 13-14, further comprising: A second energy delivery component is located on the first insulating component and has a distal end; A second insulating member extends over the second energy transmission member and has a distal end; as well as A third control unit is operably connected to the second insulating member to adjust its position relative to the second energy transmission member; The second electrode portion of the energy delivery assembly is defined along the second energy delivery member between the distal end of the second energy delivery member and the distal end of the second insulating member.

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