Arc suppression electrodes

Abstract

Methods and devices for applying electrical energy, including sub-microsecond pulsed electrical energy, to target tissue. These methods and devices can prevent or inhibit arcing and / or minimize arcing while maintaining sufficient contact during treatment. For example, electrodes are described having a surface covered with an arc suppression layer. The arc suppression layer can be separated from the electrode surface by a gap region (e.g., an air gap).

Description

Technical Field

[0001] Cross - Reference to Related Applications This patent application claims priority to U.S. Provisional Patent Application No. 63 / 284,626, filed on November 30, 2021, entitled "ELECTRODES WITH ARC MITIGATION", the entire disclosure of which is incorporated herein by reference.

Background Art

[0002] For the electro - manipulation of biological tissues and cells, electrical pulses with very short durations and high electric field strengths are used. For example, electrical pulses can be used for the treatment of tissues including benign and malignant tumors, lesions, and other conditions. Treatments with electrical pulses such as high electric field strengths and short electrical pulses can be useful for the manipulation of intracellular structures such as nuclei and mitochondria. For example, high - voltage pulse generators and treatment applicators with sub - microsecond (such as nanosecond) durations have been proposed for biological, medical, and cosmetic applications. However, such high peak electric fields are prone to arc discharges between electrodes.

[0003] Due to the very high treatment voltages and very fast pulse times, it is desirable for an applicator supplying a sub - microsecond electric field to be configured to prevent arc discharges between the electrodes to which energy is applied. It is extremely difficult to prevent arc discharges when the electrodes are surface electrodes and do not uniformly contact the target tissue, or when there is a gap between the electrode surface and the tissue, and this problem is particularly prominent when using large electrodes. This specification describes methods and devices for addressing such problems and enhancing the treatment of tissues generally using sub - microsecond pulse energies.

Summary of the Invention

[0004] Described herein are methods and devices (e.g., devices, systems, etc., including applicators for applying electrical energy) for applying electrical energy to target tissue. In particular, described herein are methods and devices for applying sub-microsecond pulsed electrical energy to target tissue that prevent or limit arcing and / or minimize arcing while maintaining adequate contact during treatment. For example, described herein are electrodes (e.g., surface electrodes) that include an electrode surface covered with an arc-suppression layer, e.g., a layer formed of a material having a lower electrical conductivity than the electrode surface. The arc-suppression layer may be flexible and / or separated from the electrode surface by a gap region. The gap region may, in some examples, be an air gap. These electrodes may have conductive surfaces with lengths of 5 mm or more, 7 mm or more, 10 mm or more, 12 mm or more, 15 mm or more, etc. Even with such very long electrodes, where maintaining uniform contact with the target tissue is difficult, the use of arc-suppression covers as described herein can prevent arcing that can occur when applying sub-microsecond pulses at high field strengths. For convenience in this specification, the electrode surface may also be referred to as the conductive surface.

[0005] The methods and devices described herein may include applicators having two or more electrodes configured to sandwich tissue between them. Also described herein are applicators including two or more sets of electrodes configured to be pressed against target tissue on a paddle region that can be easily and effectively articulated to be pressed against the target tissue. Any of the applicators described herein may have a conductive surface covered with an arc suppression layer, which may be separated from the conductive surface by a gap region (e.g., an air gap) or, in some configurations, may be in direct contact with the conductive surface. Alternatively or additionally, any of the conductive surfaces described herein may include rounded edges (fillets) to prevent charge buildup.

[0006] For example, this specification describes an electrode device for restricting arc discharge. This electrode device includes a first electrical insulating support, a first electrode supported by the first electrical insulating support and including a first electrode surface, a first arc suppression layer covering the first electrode surface, a second electrode supported by the first electrical insulating support or a second electrical insulating support and including a second electrode surface, and a second arc suppression layer covering the second electrode. The first and second electrodes are configured to allow an electrical pulse having a magnitude of at least 0.1 kV and a duration of less than 1000 nanoseconds to pass therethrough without arc discharge.

[0007] Also, this specification describes an electrode device (e.g., one configured to limit arc discharge), which includes a first electrical insulator, a first electrode supported by the first electrical insulator and including a first electrode surface, and a second electrode supported by the first electrical insulator or a second electrical insulator and including a second electrode surface. The first electrode and the second electrode are configured to pass an electrical pulse having a magnitude of at least 0.1 kV therebetween. The first electrode includes a first rounded edge on or around the first electrode surface, and the second electrode includes a second rounded edge on or around the second electrode surface. The first and second rounded edges are configured to reduce or eliminate arc discharge between the first electrode and the second electrode when passing an electrical pulse. The first electrode surface may be a tissue-facing surface or a tissue-contact surface, and the second electrode surface may be a tissue-facing surface or a tissue-contact surface. The first rounded edge may be not only on or around the first tissue-contact surface but also on or around the first non-tissue-contact surface, and the second rounded edge may be not only on the second tissue-contact surface but also on or around the second non-tissue-contact surface. In some examples, the rounded edge / fillet is configured to reduce the peak electric field by, for example, up to about 30%. In some examples, the electrode device includes an elongated shaft, and the first jaw and the second jaw are disposed at an angle (e.g., perpendicular) to the shaft and may have a curved or bent configuration. The first and second jaws may be axially movable relative to each other. In some examples, optionally, the first electrode surface may be covered by a first arc suppression layer, and the second electrode surface may be covered by a second arc suppression layer.

[0008] These electrode devices can all be configured to limit arc discharge, and include a first electrical insulating support, a first surface electrode supported by the first electrical insulating support and including a first electrode surface, and a second surface electrode supported by the first electrical insulating support or a second electrical insulating support and including a second electrode surface. The first and second surface electrodes are configured to allow an electrical pulse having a magnitude of at least 0.1 kV to pass between them. The first electrode surface is covered by a first arc suppression layer, and the second electrode surface is covered by a second arc suppression layer, and is configured to reduce or eliminate arc discharge between the first and second surface electrodes when allowing the electrical pulse to pass.

[0009] These electrode devices can all include an applicator for applying electrical energy as described herein. The electrode devices described herein can include two or more electrodes (e.g., surface electrodes), such as three or more, four or more, five or more, etc. The electrode device can be handheld, robotic, or both. The electrode device can include an elongated body and / or a handle region. The electrode device can be configured as a tip or tip region (mechanically and / or electrically) coupled to a reusable applicator handle. In some examples, the electrode device may be disposable or may have usage limitations (such as used in one treatment session or used on one patient). In some examples, the electrode device is reusable and can be, for example, sterilizable.

[0010] These devices may each include one or more electrical insulating supports. The electrical insulating support may be formed of an electrical insulating material on or within which the electrodes are held and / or formed. Suitable electrical insulating support materials such as polymer materials can be used. For example, the electrical insulating support may be formed of polyethylene (PE), polyvinyl chloride (PVC), polypropylene (PP), polyamide (PA), etc. The electrical insulating support may be formed on an applicator surface such as a flat or curved surface to assist in contact with the tissue to be treated. In some examples, the electrical insulating support may be formed on a paddle, a jo arm, or other structure that holds and supports the electrodes. In some examples, the device (e.g., an applicator device) may include two or more separate electrical insulating supports, each of which supports one or more (e.g., an array) of the electrodes.

[0011] The electrodes described herein may include plate electrodes or surface electrodes configured to apply energy in the sub-microsecond (e.g., nanosecond) range to the surface of the tissue. In any of the devices described herein, the surface electrodes may be configured to be held against the tissue to be treated (e.g., against the target region of the tissue). The surface electrodes may be substantially flat or may include a flat tissue contact surface. The surface electrodes described herein may have any suitable shape such as circular, elliptical, hexagonal, square, rectangular, etc. In some examples, the surface electrodes described herein are elongated and have a length greater than the width. In some examples, the electrodes described herein have a length that is two or more times (2.5 times or more, 3 times or more, 4 times or more, 5 times or more, etc.) the width. For example, the length of the electrode may be 2 mm or more, 3 mm or more, 4 mm or more, 5 mm or more, 6 mm or more, 7 mm or more, 8 mm or more, 9 mm or more, 10 mm or more, 11 mm or more, 12 mm or more, 13 mm or more, 14 mm or more, 15 mm or more, etc.

[0012] In any of the devices described herein, the electrode may include an electrode surface. The electrode surface may be the surface of the electrode configured to contact tissue. The electrode surface may be substantially flat, curved, (e.g., slightly) bent, or otherwise configured to be held against the target tissue surface. In some examples, the electrode surface is formed of a conductor such as a conductive metal (such as silver, stainless steel). In some examples, the electrode surface is formed of a conductive polymer. In some examples, the electrode surface is formed of a wire.

[0013] Any of the electrodes described herein may include an arc suppression layer covering the electrode surface. In some examples, the arc suppression layer is hard, and in other examples, the arc suppression layer may be formed of a flexible material such as a film, coating, etc. The conductivity (e.g., S / m at 20°C) of the material of the arc suppression layer may be lower than that of the electrode surface and slightly smaller than, approximately equal to, or larger than the conductivity of the target tissue. For example, the conductivity of the arc suppression layer may be from about 0.001 S / m to about 20 S / m (e.g., from about 0.01 S / m to about 10 S / m, from about 0.1 S / m to about 8 S / m, from about 0.1 S / m to about 5 S / m, from about 0.1 S / m to about 10 S / m, from about 0.1 S / m to about 4 S / m, from about 0.1 S / m to about 3 S / m, from about 0.1 S / m to about 2 S / m, from about 0.1 S / m to about 1 S / m, between about 0.01 S / m and about 5 S / m, between about 0.01 S / m and about 3 S / m, etc.). For example, the arc suppression layer may be formed of a polymer material doped or otherwise treated to have a conductivity within a target range (e.g., from about 0.001 S / m to about 5 S / m). The polymer material may be a flexible polymer material such as, but not limited to, silicone. The doping material (also referred to herein as a filler or a filler) may be a conductive material such as carbon (e.g., carbon nanotubes). For example, the arc suppression layer may include a silicone polymer containing a conductive filler (e.g., carbon nanotubes).

[0014] Generally, the arc suppression layer may cover the electrode surface. In some examples, the arc suppression layer is directly laminated on the electrode surface. Alternatively or additionally, the arc suppression layer may be attached with a gap or space above the conductive layer. The gap or space may be an air gap or a gap formed by a non-conductive fluid (such as air, pure water, oil, etc.). The non-conductive fluid may be compressible. The non-conductive fluid may be configured to replace another part of the electrode that is in fluid communication with the gap region between the arc suppression layer and the electrode surface. In some examples, the non-conductive fluid (e.g., air) can be discharged through the opening of the arc suppression layer. The arc suppression layer is configured to have a relaxation configuration in which the arc suppression layer is separated from the conductive electrode surface by a gap region. When a force (such as pressure, compression, vacuum, etc.) is applied to the electrode to hold or drive the target tissue, the arc suppression layer can be driven against the electrode surface so that electrical energy (such as sub-microsecond pulsed electrical energy) can be applied.

[0015] For example, all of these devices may include a gap region between the arc suppression layer and the electrode surface in a non-operating state (a state in which no force is applied to drive the arc suppression layer against the conductive surface). When a force is applied to the surface electrode (e.g., to the arc suppression layer), the arc suppression layer is driven towards the conductive surface and the gap region is collapsed. As described above, the gap region can be, for example, an air gap. Thus, the arc suppression layer can be configured to deflect against the conductive surface when a force is applied to the arc suppression layer.

[0016] The gap region can be set to any appropriate interval. For example, the gap region can have a width separating the arc suppression layer and the electrode surface of about 0.1 mm or more, about 0.2 mm or more, about 0.3 mm or more, about 0.4 mm or more, about 0.5 mm or more, about 0.1 mm to 5 mm, about 0.2 mm to 5 mm, about 0.3 mm to 5 mm, about 0.4 mm to 5 mm, about 0.5 mm to 5 mm, etc.

[0017] Each of the devices described in this specification may include two or more electrodes, each having its own electrode (e.g., a surface electrode) and an arc suppression layer. In practice, a plurality of electrodes can be formed using the same arc suppression layer, but they need to be electrically insulated from each other (therefore, in this specification, they can be referred to as different arc suppression layers such as a first arc suppression layer, a second arc suppression layer, etc.). In some examples, the arc suppression layer can be fixed to an insulating support. For example, the arc suppression layer can be adhesively fixed to the insulating support, tacked to the insulating support, or welded to the insulating support. The arc suppression layer described in this specification may also be referred to as an arc suppression film in some examples. The arc suppression layer described in this specification may completely cover the surface of the underlying electrode.

[0018] Generally, the electrodes described in this specification are configured to pass an electrical pulse having a magnitude of at least 0.1 kV and a duration of less than 1000 nanoseconds without causing an arc discharge. For example, the devices described in this specification can be configured to pass electrical pulses having magnitudes such as about 1 kV or more, about 2 kV or more, about 3 kV or more, about 5 kV or more, about 6 kV or more, about 7 kV or more, about 8 kV or more, about 9 kV or more, about 10 kV or more, about 0.1 kV to about 100 kV, about 1 kV to about 100 kV, about 3 kV to about 100 kV, about 5 kV to about 100 kV, etc. The pulse can be a sub-microsecond pulse (e.g., less than about 1000 ns, e.g., about 1 ns to about 1000 ns, about 1 ns to about 950 ns, about 1 ns to about 900 ns, about 5 ns to about 1000 ns, about 5 ns to about 950 ns, about 5 ns to about 900 ns, etc.).

[0019] These devices can all be configured as clamp-type or gripping-type applicators. For example, these devices all have a first electrode on a first jaw of the applicator and a second electrode on a second jaw of the applicator. The first jaw and the second jaw can be configured to be openable and closable relative to each other to fix the tissue to be treated therebetween. These jaws can be configured to open and close such that the first surface electrode and the second surface electrode remain parallel to each other (e.g., parallel-opening jaws). The jaws may be configured to open in a scissor-like manner. The jaws can be configured such that one jaw moves relative to the other jaw. For example, the first jaw may be configured to move axially relative to the second jaw (or vice versa).

[0020] The electrodes can be on the clamping surfaces of the jaws, for example, on the surfaces facing each other. Alternatively, the electrodes can be on the lateral faces of the jaws, and the opening and closing of the jaws can cause the distance between the electrodes to increase or decrease, but the tissue between the electrodes may not be pinched.

[0021] In some examples, the electrodes are not on opposing jaws but on the same support structure. This support structure can be configured to expand and contract so that the user can (or in some examples automatically) adjust the distance between the electrodes. In some examples, the device can be configured to detect the distance between the electrodes and the jaws. For example, the device can incorporate a linear potentiometer. Alternatively or additionally, the first electrode and the second electrode may be separated by a certain distance. In some examples, the electrodes are arranged on a paddle structure that allows articulation to enable good contact with the tissue and / or adjustment of the treatment area.

[0022] As described above, the first surface electrode and the second surface electrode may each include, for example, an elongated surface electrode having a length greater than the width. For example, the electrode surface may be elongated and have a length greater than its width. In one example, the surface electrode, for example, the first electrode and / or the second surface electrode, may have a length greater than 5 mm. In any of the embodiments having an arc suppression layer, the arc suppression layer may extend further on the electrode surface than the electrode surface itself, or may be the same size as the electrode surface.

[0023] The electrodes described herein may have rounded edges / fillets on the electrode surface, whereby the possibility of arc discharge can be further reduced.

[0024] The electrodes (e.g., the first surface electrode and the second surface electrode) may be formed of any suitable conductive material. For example, the surface electrode can be formed of stainless steel.

[0025] In any of these devices, the arc suppression layer, e.g., the first and second arc suppression layers, may include a flexible membrane.

[0026] All of these devices may include one or more suction ports that penetrate an insulating support and are configured to apply a suction force to draw tissue toward the electrodes. For example, the device may include one or more suction ports adjacent to the surface electrode, including, but not limited to, between the surface electrodes, under the surface electrodes, around the surface electrodes, etc. Thus, suction can be applied, for example, from the distal end, through the applicator or through a suction channel in communication with the applicator, to ensure contact between the tissue and the surface electrode. In some examples, suction may be used to press the arc suppression layer against the electrode surface.

[0027] For example, in this book, even when using a large surface electrode with high voltage, sub-microsecond pulses, an electrode device for suppressing or preventing arc discharge is described. This electrode device includes a first electrical insulating support, a first surface electrode supported by the first electrical insulating support and including a first electrode surface, and a first flexible arc suppression layer covering the first electrode surface and separated from the first electrode surface by a first gap region. The first flexible arc suppression layer, and is supported by the first electrical insulating support or a second electrical insulating support. A second surface electrode including a second electrode surface, and a second flexible arc suppression layer covering the second surface electrode and separated from the second electrode surface by a second gap region. The first and second electrodes are configured to allow an electrical pulse having a magnitude of at least 0.1 kV and a duration of less than 1000 nanoseconds to pass through without arc discharge.

[0028] Also described herein are methods of using any of these devices to treat tissue. These methods can be specific methods for treating specific indications, including, but not limited to, methods for treating endometriosis, methods for treating vocal cord lesions (e.g., vocal cord polyps, nodules and / or cysts), methods for treating heart tissue (e.g., methods for treating atrial fibrillation), etc. For example, a method of applying pulsed electric field energy to a target tissue includes pressing the first surface electrode against the target tissue such that a first arc suppression layer covering at least a portion of the first electrode surface is driven against the first electrode surface, and pressing the second surface electrode against the target tissue such that a second arc suppression layer covering at least a portion of the second electrode surface is driven against the second electrode surface, and applying a plurality of electrical pulses having a magnitude greater than 0.1 kV and a duration of less than 1000 nanoseconds between the first and second surface electrodes to treat the target tissue while suppressing or preventing arc discharge between the first electrode surface and the second electrode surface.

[0029] In some examples of the method, instead of the first arc suppression layer and the second arc suppression layer, rounded edges are used for the first electrode and the second electrode to treat tissue while suppressing or preventing arc discharge between the first electrode and the second electrode. Any of these methods may include first and second surface electrodes that are pressed against the target tissue by compressing the target tissue therebetween. For example, suction can be applied from an applicator holding the first and second surface electrodes to press the first and second surface electrodes against the target tissue, and the first and second surface electrodes can be fixed to the target tissue. In an example using an arc suppression layer, the first surface electrode can be pressed against the target tissue to move the first arc suppression layer to a first air gap between the first arc suppression layer and the first electrode surface. The second surface electrode can be pressed against the target tissue to move the second arc suppression layer to a second air gap between the second arc suppression layer and the second electrode surface.

[0030] The step of pressing the first surface electrode against the target tissue may include pressing the first electrode surface such that the rounded edge of the first electrode surface contacts the target tissue.

[0031] As described herein, the first arc suppression layer may have a conductivity that is less than the conductivity of the first electrode surface.

[0032] Treating tissue while suppressing or preventing arc discharge may include suppressing or preventing arc discharge between non-tissue contact portions or regions of the first electrode surface and the second electrode surface.

[0033] As described above, these methods can be methods for treating endometriosis. For example, in one embodiment, the step of pressing the first surface electrode against the target tissue may include pressing the first surface electrode against endometrial tissue.

[0034] These methods can be methods for treating the vocal cords as described above. For example, the step of pressing the first surface electrode against the target tissue may include pressing the first surface electrode against the vocal cord tissue.

[0035] These methods can be methods for treating cardiac tissue as described above. For example, the step of pressing the first surface electrode against the target tissue may include pressing the first surface electrode against the cardiac tissue. For example, in some embodiments, a method of applying pulsed electric field energy to cardiac tissue is provided, the method comprising pressing a first electrode surface of a first electrode against a first location on the cardiac tissue, the first electrode having a first rounded edge on or around the first electrode surface; pressing a second electrode surface of a second electrode against a second location on the cardiac tissue, the second electrode having a second rounded edge on or around the second electrode surface; and applying a plurality of electrical pulses having a magnitude greater than 0.1 kV and a duration less than 1000 nanoseconds between the first and second surface electrodes to treat the cardiac tissue while suppressing or preventing arcing between the first edge and the second rounded edge, between the first electrode and the second electrode.

[0036] A method of applying pulsed electric field energy to a target tissue includes pressing a first surface electrode against the target tissue, wherein the first surface electrode has a first conductive surface separated from a first flexible arc suppression layer by a first air gap, and the first arc suppression layer is pressed against the first conductive surface over at least a region of the first conductive surface; pressing a second surface electrode against the target tissue, wherein the second surface electrode has a second conductive surface separated from a second flexible arc suppression layer by a second air gap, and the second arc suppression layer is pressed against the second conductive surface over at least a region of the second conductive surface; and applying a plurality of electrical pulses having a magnitude greater than 0.1 kV and a duration less than 1000 nanoseconds between the first surface electrode and the second surface electrode to treat the tissue without arc discharge between the first conductive surface and the second conductive surface.

[0037] A method of applying pulsed electric field energy to a target tissue may include pressing the first surface electrode against the target tissue such that a first arc suppression layer covering at least a portion of the first electrode surface is actuated against the first electrode surface; pressing the second surface electrode against the target tissue such that a second arc suppression layer covering at least a portion of the second electrode surface is actuated against the second electrode surface; and applying a plurality of electrical pulses having a magnitude greater than 0.1 kV between the first and second surface electrodes to treat the target tissue while suppressing or preventing arc discharge between the first electrode surface and the second electrode surface.

[0038] The devices described herein may be particularly suitable for laparoscopic indications. These devices can be used to treat tissue surfaces within body cavities. For example, these instruments can be used for laparoscopic endometriosis (e.g., target tissues of the female reproductive system, such as the ovaries, fallopian tubes, ligaments supporting the uterus (uterosacral ligaments), posterior cul-de-sac, i.e., the space between the uterus and the rectum, anterior cul-de-sac, i.e., the space between the uterus and the bladder, outer surface of the uterus, endometrium of the pelvic cavity, and in some cases, the intestine, rectum, bladder, vagina, cervix, and / or vulva). The devices described herein may be particularly suitable for the treatment of the heart (e.g., to perform the maze procedure used for the treatment of arrhythmias (atrial fibrillation or AF)), and for the treatment of the oral cavity, esophagus, etc.

[0039] For example, the devices also described herein include an elongated body, a paddle region extending distally from the elongated body, the paddle region including a lateral side and two or more surface electrodes extending parallel along the lateral side, a joint region coupling the elongated body to the paddle region, the joint region configured to articulate the paddle region in a plane extending through the elongated body, and a proximal handle including a control unit configured to move the distal paddle more than 180 degrees (e.g., 190 degrees, 200 degrees, etc.).

[0040] Any of these devices may include an elongated body. The elongated body may be rigid, straight, or curved. In some examples, the elongated body is sized to be insertable into a body region (e.g., having a length of about 6 inches to 24 inches, etc.). The elongated body may be configured to be held by hand, or may be inserted through an introducer or a mount.

[0041] The distal paddle region can support two or more surface electrodes and can include or be formed as part of the electrically insulating support. The paddle region can be elliptical in shape and / or have an atraumatic distal end region. The paddle region can be configured to contact the surface of the tissue to be treated (target tissue) on a lateral side. The lateral side can be a side perpendicular to the distal end of the device. In some examples, in a relaxed (non-articulated) state, the paddle region is configured to be aligned with the longitudinal axis of the elongate member.

[0042] The articular region can be configured to actuate the paddle region, and thus the surface electrodes, to move within a single plane. For example, the articular region can include a hinge region or a series of hinges forming the hinge region. These hinges can include one or more pin joints or can be formed in a rimming hinge configuration. The articular region can be articulated by one or more tendons (e.g., wires, strings, cords, etc.) that can be used to pull or push the distal end of the articular region (e.g., the paddle region relative to the elongated housing) relative to the proximal end of the articular region. The articular region can be biased in one direction, e.g., to preferentially bend in one direction (e.g., "up" or "down") or return to an unbent configuration. The articular region can be configured to bend within a single plane, e.g., to move the paddle region between ±45°, ±50°, 60°, 65°, 70°, 75°, 80°, 85°, 90°, 95°, 100°, 105°, 120°, etc. Thus, the device may be configured to articulate the distal paddle through 90 degrees, 100 degrees, 110 degrees, 120 degrees, 130 degrees, 140 degrees, 150 degrees, 160 degrees, 170 degrees, 180 degrees, 190 degrees, 200 degrees, 210 degrees or more, etc. The articulation region may be configured as an articulation joint.

[0043] Any of these devices may include a control unit that controls the articulation movement of the device, including the articulation movement of the joint region. The control unit may be on the handle. The control unit (the "articulation movement control unit") may be a slider, a knob, a pulley, a dial, or the like. The control unit may be mechanical or electrical. Any of these devices may include locking and lock control for locking and maintaining a selected joint angle. For example, the device may include an articulation control unit having a lock button, a knob, or the like for holding (locking) the selected angle. The lock may be mechanical and can prevent further movement of a tendon or gear configured to drive the articulation movement of the joint region. In some examples, the lock may include a gear and a pawl. The lock may include a friction lock for preventing or restricting the movement of a tendon connecting the joint regions.

[0044] Any of these devices may include one or more suction ports on the lateral side and may be configured to apply suction to fix two or more surface electrodes to the tissue surface. In some examples, the paddle region is relatively flat, has a flat or curved side on one side, and the opposite side may also be flat or curved at a width. This width can be relatively narrow (e.g., 1 mm to 10 mm, 1 mm to 7 mm, 1 mm to 6 mm, etc.). The opposite side (back side) of the lateral surface is also called the back surface of the paddle region. In some examples, the back surface of the paddle region may comprise an electrical insulator. In some examples, this back surface may include a set of second surface electrodes. The device may be configured such that a user (or a controller such as a robot controller) can select whether to apply energy from a set of surface electrodes on the lateral side of the paddle region or from a set of electrodes on the back surface. Accordingly, the device may be configured to multiplex between a first set of surface electrodes on the side surface and a second set of surface electrodes on the back surface. For example, the handle region may include a control unit (e.g., a switch) for switching between sets of electrodes. Accordingly, all of these devices may include a second set of two or more surface electrodes on the back surface of the paddle region opposite the side surface and a control configured to operate either two or more surface electrodes on the side surface or the second set of two or more surface electrodes on the back surface of the paddle region.

[0045] In some examples, the lateral side is a flat lateral surface. Alternatively, the lateral side is curved, for example, it may be slightly curved (e.g., having a radius of curvature greater than 10 mm), and the lateral side may be curved about an axis perpendicular to the long axis (proximal-distal axis). Alternatively, in some examples, the paddle region, particularly the paddle region, may be curved in the long axis direction.

[0046] Any of these devices (including those shown in FIGS. 3 to 9) can be configured to adjust the distance between the surface electrodes. In some embodiments, the paddle region may be configured to widen (e.g., in a direction perpendicular to the major axis) such that the paddle region (and in some embodiments the lateral sides of the paddle region) widen laterally to increase the distance between the two or more surface electrodes. The device may include a control unit configured to increase or decrease the distance between the two or more surface electrodes, such as an expansion control unit on the handle. This expansion can be driven by a tendon (such as a wire, cord, etc.) and may be biased to an expanded configuration or a non-expanded configuration. The device may also include an expansion lock configured to fix the paddle region in a selected expanded state.

[0047] Generally, the two or more surface electrodes may include three or more surface electrodes. The surface electrodes may be the same as those described above. For example, each of the surface electrodes may include an electrode surface and an arc suppression layer (e.g., a flexible arc suppression layer) covering the electrode surface. In some examples, the flexible arc suppression layer may be separated from the electrode surface by a gap region (e.g., an air gap). The two or more surface electrodes may have rounded edges.

[0048] The surface electrodes may extend parallel to each other along the length from the distal to the proximal of the side surface, for example, over a length of 5 mm or more (e.g., 6 mm or more, 7 mm or more, 8 mm or more, 9 mm or more, 10 mm or more, etc.).

[0049] In some examples, the device may include an elongated body, a paddle region extending distally from the elongated body, the paddle region including lateral sides and two or more elongated surface electrodes extending parallel along the lateral sides, a joint region coupling the elongated body to the paddle region, the joint region configured to allow the paddle region to articulate in a plane extending through the elongated body, and a handle at the proximal end including a control unit configured to allow the distal paddle to move more than 200 degrees.

[0050] Also, this specification describes methods of using these devices, including (but not limited to) methods of using these devices in laparoscopic surgery. For example, as described above, these methods can be used for the treatment of endometriosis, respiratory (e.g., bronchial) indications, heart tissue and / or oral / nasal indications (e.g., vocal cords / vocal folds), etc. For example, a method of treating tissue may include inserting a device including an elongated body into a subject's body, bending an articulation region at a distal end of the elongated body such that a paddle region at a distal end of the articulation region moves within a plane extending through the elongated body, applying a side surface of the paddle region against a target tissue region such that two or more surface electrodes extending parallel along the side contact the target tissue, and applying a plurality of electrical pulses having a magnitude greater than 0.1 kV and a duration less than 1000 nanoseconds between the two or more surface electrodes to treat the target tissue. The paddle region can move 180 degrees or more within a plane extending through the elongated body.

[0051] These methods may each include repositioning the device with respect to another region of the target tissue and applying a second plurality of electrical pulses. The step of disposing the side of the paddle region against the target tissue may include pressing a surface electrode comprising a conductive surface covered by an arc suppression layer against the target tissue such that the arc suppression layer of each surface electrode is driven against the conductive surface of each surface electrode.

[0052] The step of driving an arc suppression layer (which may be a flexible layer) of each surface electrode against the conductive surface of each surface electrode may include displacing a gap region between the flexible arc suppression layer of each surface electrode and the conductive surface of each surface electrode. The gap region may include an air gap.

[0053] The step of applying the side of the paddle region to the target tissue may include pressing the side of the paddle region against the endometrial tissue. The step of applying the side of the paddle region to the target tissue may include pressing the side of the paddle region against the vocal cord tissue. The step of applying the side of the paddle region to the target tissue may include pressing the side of the paddle region against the heart tissue.

[0054] In general, the techniques and features described herein (e.g., including electrodes and devices) may be applied to or adapted for use with any of the devices and methods described in the PCT application PCTUS2021035146, filed Jun. 1, 2021, entitled "HIGH-VOLTAGE MINIMALLY INVASIVE APPLICATOR DEVICES FOR SUB-MICROSECOND PULSING", which is incorporated herein by reference in its entirety.

[0055] The devices described herein can be used with any pulse generator that includes a pulse generator configured for sub-microsecond (e.g., nanosecond) high voltage pulse generation. Sub-microsecond (e.g., nanosecond) high voltage pulse generators suitable for biological and medical applications include U.S. Patent Application No. 2008 / 0231337, U.S. Patent Application No. 2010 / 0038971, and U.S. Patent Application No. 2021 / 0187292. The entire contents of these publications are incorporated herein by reference.

[0056] All of the methods and devices described herein are contemplated herein in any combination of the various disclosed features and can be used to achieve the advantages described herein.

Brief Description of the Drawings

[0057] This patent or application includes one or more color drawings. Copies of the color drawings of this patent or patent application publication are provided by the Patent Office upon request and payment of the necessary fees.

[0058] A better understanding of the features and advantages of the methods and apparatuses described in this specification will be obtained by reference to the following detailed description, which illustrates exemplary embodiments, and the accompanying drawings.

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DETAILED DESCRIPTION OF THE INVENTION

[0059] Described herein are methods and apparatuses (e.g., devices, systems, etc.) for applying electrical energy to tissue. In particular, these methods and apparatuses may be particularly suitable for the application of high electric fields such as sub-microsecond pulses (e.g., nanosecond pulses). The application of high electric field pulses may cause unwanted arc discharges, particularly when applying energy between electrodes that are not in uniform contact with the target tissue. This limits the size of the electrodes, and shorter and smaller electrodes may be advantageous, but additional treatment steps are required to treat larger tissue areas. The methods and apparatuses described herein are configured to prevent or minimize / limit arc discharges when used with larger surface electrodes (e.g., having a length of 4 mm or more, 5 mm or more, 6 mm or more, 7 mm or more, 8 mm or more, 9 mm or more, 10 mm or more, etc.) and / or when used in non-uniform tissue regions. Further, with the methods and apparatuses described herein, transmural lesions can be obtained across the desired length of the tissue being treated.

[0060] Also described herein are applicators that include surface electrodes that can clamp tissue to provide treatment using high electric fields such as sub-microsecond pulses. Some examples of the applicators described herein are configured to apply energy to the tissue surface using a paddle region that includes a surface electrode. Any of these devices can be configured for laparoscopic or other minimally invasive uses and procedures. These devices can also be configured to prevent arc discharges between surface electrodes that include different joe surface electrodes even when a portion of the surface electrode is exposed to blood or air (e.g., not clamped to or pressed against tissue).

[0061] Although many of the examples described herein explain the use of sub-microsecond pulses of high electric field strength, any of these devices and methods may be adapted for use with other forms of electrical energy.

[0062] This book describes devices and apparatuses including laparoscopic devices, catheters, etc. that can be configured as such, or that can be configured to be introduced or used through the lumens of laparoscopic devices, endoscopes, or catheters, applicators, applicator tools, applicator tips, etc. Also, in this book, a method for treating a patient is described in which, using any of these devices, therapeutic energy including, but not limited to, short high electric field strength electrical pulses is effectively applied while minimizing or avoiding the risk of damage to tissue such as arc discharge. These applicators can be used for minimally invasive procedures and can be particularly suitable for treating various lesions, conditions, disorders, and diseases, as described in more detail below. Such applications are particularly suitable for use in various fully automated and semi-automated systems such as robotic systems. In particular, the devices described in this book can be configured as devices (e.g., laparoscopic devices) that can be used with various different generator systems, as described in more detail in this book.

[0063] Accordingly, the devices described in this book can be configured for manual or automatic (e.g., robot-assisted) control. In some examples, these devices can be integrated into a system configured to be attached or coupled to a movable (e.g., robotic) arm of a robotic system such as a robotic therapy system or a robotic surgery system. It should be understood that such a surgical system is intended to cover any robotic therapy system (including cosmetic applications) and can include a robotic system having a guidance function. In some examples, instruments can be guided and controlled by a robotic system during surgery. For example, the devices described in this book can be used through one or more operating channels of a robotic system.

[0064] In embodiments that include a joystick, the device described in this book can include an elongated applicator tool that can be operated proximally (automatically or manually) to articulate a distal region (also called the tip), including adjusting the opening and closing of the joystick, adjusting and / or controlling the angle of the distal end region (e.g., the paddle region), and / or adjusting the spacing between two or more surface electrodes in the distal end region. In some examples, the applicator described in this book can include a proximal handle portion, an elongated body, and a distal end region that includes two or more electrodes. The proximal handle can include one or more controls for operating the distal end region of the applicator tool, including articulating the distal tip region to change the angle of the distal tip region relative to the elongated body, the rotational position of the distal tip region relative to the elongated body, etc. Also, the distance between pairs or sets of electrodes (e.g., cathode and anode) or pairs of surface electrodes (cathode and anode) can be adjusted by one or more control units (including an automatic control unit).

[0065] The applicator is also referred to as an elongated applicator tool. The elongated body portion can be rigid, bendable, or flexible. In some examples, the elongated body portion can be a catheter or a catheter body.

[0066] According to one aspect, the devices described herein are configured as medical devices and instruments for use in minimally invasive procedures that are introduced through natural openings (e.g., mouth, anus, etc.) or small incisions and can be manipulated using additional tools such as obturators, cameras, forceps, graspers, etc. In some examples, the devices described herein can be used through the working channel of an endoscope. In some examples, these devices may be configured as catheters or may include an elongate catheter body. In any of the devices or systems described herein, the elongate applicator can be configured as a laparoscope (and is also referred to herein as a laparoscope, laparoscopic device, or laparoscopic instrument). The laparoscope used herein optionally includes one or more visualization components (e.g., optical fibers, cameras, lenses, filters, etc.). Thus, any of the devices described herein can be configured as a scope. These devices can be configured to safely and reliably deliver pulses such as microseconds, nanoseconds, picoseconds, etc., and can include electric fields with pulse widths shorter than 0.1 nanoseconds (ns) to less than 1000 nanoseconds, or such as 1 picosecond, which is also referred to as a sub-microsecond pulse electric field. This pulse energy can have a high peak voltage of 0.5 to 5 kilovolts / centimeter (kV / cm), 10 kV / cm, 20 kV / cm, 100 kV / cm or higher. In the treatment of living cells, a number of periodic pulses with frequencies from 0.1 Hz to 10,000 Hz can be used to induce controlled cell death, for example, in abnormal growths such as diseased tissue and cancerous, precancerous, or benign tumors. Such selective treatment of tumors, lesions, or other unwanted growths with high-voltage sub-microsecond pulse energy can induce controlled cell death within the treated cells without substantially affecting the normal cells of the surrounding tissue due to its non-thermal nature. The subject can be a patient (including animals, human or non-human). A user can operate the devices described herein on the subject. The user can be a physician (doctor, surgeon, etc.), medical technician, nurse, or other care provider.

[0067] Thus, the application of high-voltage high-speed electrical pulses can include, for example, the application of an electrical pulse train having a pulse width of from 0.1 nanosecond (ns) to 1000 nanoseconds. The application of high-voltage high-speed electrical pulses can include, for example, the application of a sub-microsecond electrical pulse train having a peak voltage of from 1 kilovolt per centimeter (kV / cm) to 500 kV / cm. The step of applying high-voltage high-speed electrical pulses can include, for example, applying a sub-microsecond electrical pulse train at a frequency of from 0.1 Hz to 10,000 Hz.

[0068] For example, this document describes an apparatus for treating tissue. For example, any suitable tissue can be treated, including tissue that fits between the jaws of a treatment applicator. Some examples of tissues that can be treated with the apparatus and methods of the present disclosure include one or more organs (e.g., pharynx, esophagus, stomach, small intestine, large intestine, liver, gallbladder, mesentery, pancreas, larynx, trachea, bronchi, lungs, diaphragm, kidneys, bladder, urethra, ovaries, fallopian tubes, uterus, vagina, testes, epididymis, vas deferens, prostate, bulbourethral gland, pituitary gland, pineal gland, thyroid gland, adrenal glands, heart, arteries, veins (such as pulmonary veins), lymph nodes, lymphatic vessels, spleen, thymus, skin, eyelids, lips, tongue, ears, nose, vocal cords, etc.). In some examples, the apparatus and methods described in this document can be used to treat one or more of these tissues as part of a minimally invasive treatment. In some examples, this treatment can be for the treatment of cancer, heart disease, endometriosis, etc. In some examples, the methods and apparatus described in this document can be used to treat one or more tumors, including cancerous, pre-cancerous, benign, or non-malignant tumors, lesions, or growths.

[0069] These devices can all be used with a pulse generator. For example, the tissue treatment system described herein can include an elongate applicator tool as described herein (e.g., an elongate body having, in some examples, a distally located region that articulates and that has a set of electrodes at its distal end region), and a pulse generator configured to generate a plurality of electrical pulses having a magnitude of at least 0.1 kV and a duration of less than 1000 nanoseconds. The system can include a connector, such as a high voltage connector adapted to couple the elongate applicator tool to the pulse generator, and the pulse generator can include a port configured to connect to the high voltage connector.

[0070] FIG. 1 is a diagram illustrating an example of a system 100 (also referred to herein as a high voltage system or a sub-microsecond generation system) for supplying high voltage, high speed pulse electrical energy, which can include an elongate applicator 102 (shown schematically), a pulse generator 107, a footswitch 103, and a user interface 104. The system 100 can provide high voltage electrical energy pulses for treating tissue that includes one or more organs (e.g., pharynx, esophagus, stomach, small intestine, large intestine, liver, gallbladder, mesentery, pancreas, larynx, trachea, bronchi, lungs, diaphragm, kidneys, bladder, urethra, ovaries, fallopian tubes, uterus, vagina, testes, epididymis, vas deferens, prostate, bulbourethral glands, pituitary gland, pineal gland, thyroid gland, adrenal glands, heart, arteries, veins (such as pulmonary veins), lymph nodes, lymphatic vessels, spleen, thymus, skin, eyelids, lips, tongue, ears, nose, vocal cords, etc.). In some examples, the devices and methods described herein can be used to treat one or more of these tissues as part of a minimally invasive treatment. As noted above, in some examples, the methods and devices described herein can be used to treat one or more tumors, including cancerous, pre-cancerous, benign or non-malignant tumors, lesions or growths. In some other examples, the methods and devices described herein can be used to treat any viable tissue or cells.

[0071] The foot switch 103 is connected to a housing 105 (capable of accommodating electronic components) via a cable and connector 106. The elongated applicator tool 102 includes electrodes and is connected to the housing 105 and the electronic components therein through a cable 137 and a high voltage connector 112. The high voltage system 100 may also include a handle 110 and a storage drawer 108. The system 100 may also include a holder (e.g., a holster, a carrier, etc.) (not shown) configured to hold the elongated applicator tool 102. The system 100 includes a controller 144 (schematically shown in FIG. 1), which can send signals to pulse control elements within the system 100 and control the operation of a pulse generator. The controller 144 includes one or more processors and can be directly or indirectly coupled to the pulse generator. The controller can receive inputs from one or more input units and provide outputs to one or more output units (e.g., a monitor / touch screen / interface, etc.). The controller 144 can be a microcontroller. The controller includes a control circuit and can include or be coupled to a memory, communication (e.g., wireless and / or wired) circuits, etc.

[0072] A human operator can select pulse number, amplitude, pulse duration, and frequency information, for example, by entering parameters into the keypad or touch screen of the interface 104. In some examples, the pulse width can be varied. The controller 144 can send signals to pulse control elements within the system 100. In some examples, an optical fiber cable is used, which enables control signal transmission and electrically insulates the contents of a metal cabinet having a sub-microsecond pulse generation system 100, such as a high voltage circuit, from the outside. To further electrically insulate the system, the system 100 may be powered by a battery rather than being powered from an outlet.

[0073] The elongated applicator tool 102 may be hand-held (e.g., by a user) or attached to a robotic system's movable arm, and its operation is at least partially automated or fully automated, including computer control.

[0074] Figures 2A - 2H show examples of non-penetrating electrodes such as surface electrodes or plate electrodes that can be used with any of the devices described in this document. For example, FIGS. 2A and 2B show an example of a surface electrode assembly 200 that includes an electrically insulating support 207. The electrically insulating support can be formed of any suitable insulating material (e.g., polymeric materials such as PE, PVC, PP, and / or PA). As shown in FIG. 2B, the electrode 205 includes an exposed (e.g., upper) electrode surface 208 that is curved so as not to have sharp or steep edges. In this example, all edges of the electrode surface have a rounded shape 206 (e.g., including a fillet) having a radius of curvature of, for example, about 1 mm or more as shown in FIG. 2A. FIG. 2A is a top view and FIG. 2B is a perspective view from a cross-section (B - B'). The electrode 205 is formed of any suitable conductive material and can be coupled (e.g., within the support 207) to an electrical connector (not visible in FIGS. 2A - 2B) for coupling to a pulse generator.

[0075] Figures 2C and 2D show another example of a surface electrode assembly 200' similar to that shown in FIGS. 2A-2B, which includes an electrical insulating support 207 that supports electrodes 205 and also has an arc suppression layer 215 that covers the exposed (e.g., top) conductive surface of the electrodes 205. The arc suppression layer 215 has a conductivity lower than that of the electrode surface and can preferably be formed of a material having a conductivity approximately the same (within 0.1 to 10 times) as the conductivity of the tissue to be treated. Since the arc suppression layer has electrical conductivity intermediate between the electrodes 205 and the insulating support 207, it is also referred to as an intermediate conductivity layer or an intermediate conductive cover. In some examples, the arc suppression layer may have an electrical conductivity one or two orders of magnitude or more lower than the electrical conductivity of the target tissue that it contacts during use. For example, the electrical conductivity of the arc suppression layer can be about 0.01 to 20 times (e.g., 0.1 to 10 times, 0.1 to 5 times, etc.) the electrical conductivity of the tissue to which it is applied (e.g., skin, heart tissue, female reproductive tract tissue, etc.). In some examples, the electrical conductivity (σ) of the arc suppression layer can be from about 0.01 Siemens per meter (S / m) to about 20 S / m (e.g., about 0.01 S / m to 10 S / m, about 0.01 S / m to 5 S / m, about 0.1 S / m to 20 S / m, about 0.1 S / m to 10 S / m, about 0.1 S / m to 5 S / m, about 0.1 S / m to 1 S / m, etc.).

[0076] The arc suppression layer may be any suitable thickness, such as, for example, a thickness of 0.01 mm to 10 mm, a thickness of 0.01 mm to 5 mm, a thickness of about 0.01 mm to 3 mm, a thickness of about 0.1 mm to 10 mm, a thickness of about 0.1 mm to 5 mm, a thickness of about 0.1 mm to 3 mm, etc. The arc suppression layer can be formed of a biocompatible polymer material. In some examples, particularly (but not limited to) when the electrode assembly includes a gap region (e.g., an air gap) between the arc suppression layer and the electrode surface, the arc suppression layer may be formed of a flexible material. The arc suppression layer may be formed of a polymer material such as silicone that has been doped or otherwise treated to include a material that provides conductivity within a specified range, such as carbon nanotubes. For example, in some variations, the arc suppression layer is formed of silicone that includes carbon black or other conductive materials to have a conductivity within the above range. In some examples, the arc suppression layer is rigid and can be formed of an inflexible polymer material, particularly when applied directly as a cover to the electrode surface.

[0077] In the surface electrode assembly 200’ shown in FIGS. 2C and 2D, an arc suppression layer 215 is applied to the exposed electrode surface 208 of the electrode 205. In some examples, the arc suppression layer may be separated from the electrode surface exposed by the gap region, as shown in FIGS. 2E - 2H. In FIGS. 2E - 2H, the arc suppression layer 215 is applied over the open or exposed electrode surface 208 of the electrode 205, spaced apart by a gap region 217. The gap region may be any suitable distance and generally may include an insulating fluid (e.g., air).

[0078] In use, an assembly 200’’ having a plate or surface electrode 205 and an electrically insulating (e.g., electrically insulating type) support 207, shown in FIGS. 2E and 2F, is applied to tissue. As shown in FIG. 2H, a force 225 is applied to the arc suppression layer 215, and due to the force 225 during application, the arc suppression layer 215 is pushed to contact the exposed electrode surface beyond the gap region 217. When this force is removed, as shown in FIG. 2G, the arc suppression layer 215 can restore the gap region 217.

[0079] Each example shown in FIGS. 2A-2B, 2C-2D, and 2E-2H can reduce or prevent arc discharge when the surface electrode is used as part of the device described herein. For example, using a rounded edge (e.g., 206) can prevent or at least minimize the occurrence of arcs. Applying an arc suppression layer 215 can minimize or prevent arc discharge even in regions where the tissue is not in uniform contact with the surface electrode. Similarly, the surface electrodes shown in FIGS. 2E-2F can further limit or prevent arc discharge when the surface electrode is used as part of the device, as will be described in more detail below.

[0080] The rectangular body of the electrode 205 under the electrode surface 208 shown in FIGS. 2A-2H may be formed of the same conductive material as the electrode surface 208 (e.g., a conductive metal such as stainless steel) or may be formed of another conductor. Any of the devices described herein can be configured to include the surface electrodes shown and described in FIGS. 2A-2H.

[0081] According to another aspect of the present disclosure, FIGS. 3A-3E show an example of a device configured for laparoscopic use that includes a distal paddle region having two surface electrodes. This device 300 includes an elongated body 304 that extends proximally, for example, to a connection to a handle or a movable arm (not shown). The paddle region 311 extends distally from the elongated body. The paddle region includes a lateral side and two surface electrodes 313, 313' that extend parallel along the lateral side. Also shown is an articulation region 309 that couples the elongated body to the paddle region. The articulation region in this example is configured to articulate the paddle region within a plane (e.g., "up" and "down" in FIG. 3A) that extends through the elongated body. In FIG. 3A, a state where the paddle region is articulated upward is shown. As described above, the device may include, at its proximal end, a handle (not shown) that includes a control unit (e.g., an articulation control unit) configured to articulate the distal paddle within a plane.

[0082] Figure 3B shows an example of the side 314 of the paddle region 311 including the first electrode 313 and the second electrode 313'. As described above, these surface electrodes can be configured as shown in FIGS. 2A - 2H. For example, each may include a semiconductive layer, a rounded edge, and in some examples, an air gap between the arc suppression layer and the electrode surface.

[0083] Figures 3C, 3D, and 3E show side views of an example of the device of FIGS. 3A - 3B undergoing an articulation movement of approximately 200 degrees within a plane (in this example, this plane is the sheet plane). In FIG. 3C, the device 300 is articulated approximately 100 degrees upward, and this configuration can be used to press the side of the paddle region against tissue in front of the device. In FIG. 3D, the device is shown in a straight state (e.g., for insertion into an anatomical structure or tissue). In this straight configuration, the device 300 can be inserted laparoscopically through a standard port. Once inside the body, the device can be articulated or rotated to position the surface electrodes against the target tissue. The electrodes can be pressed against tissue located on the side of the device. In FIG. 3E, the device 300 is shown in an articulated state approximately 100 degrees downward. This configuration can be used to treat tissue oriented proximal to the distal end of the device, e.g., on the side.

[0084] The elongated body is generally a cannula and may include one or more channels such as a working channel, a scope channel, etc. The elongated body may also secure or guide an articulation tendon (not shown) for articulating the hinge joint and electrical wiring for connecting to the electrodes. In the examples of FIGS. 3A - 3E, the wiring (e.g., the one electrically coupling the surface electrodes to the connector at the proximal end) is not visible, nor are the articulation cables and / or vacuum lines or tubes.

[0085] The examples shown in FIGS. 3A to 3E may have a diameter (e.g., in a direction orthogonal to the longitudinal axis) of about 2 mm to about 15 mm, and the examples shown in FIGS. 3A to 3E have a diameter of about 4 mm. The illustrated device may include one or more vacuum ports on the side of the device, e.g., a portion adjacent to the surface electrode, through which a suction force can be applied to hold the electrode surface against the tissue and / or remove the air around the electrode. Alternatively, the device may be used by simply pressing it against the tissue without applying a vacuum.

[0086] Figures 4A - 4C show another embodiment of an apparatus 400 that includes a paddle region 411 coupled to an elongated body (e.g., cannula 404) via a joint region 409. The joint region (e.g., articulation) may include one or more internal cables (not shown) and tubes (not shown). In the example shown in Figures 4A - 4C, the apparatus includes three surface electrodes 413, 413', 413'' on the paddle region 411. In this configuration, the paddle region is configured to expand laterally outward away from the long axis of the apparatus to increase the spacing between the surface electrodes. In Figure 4A, the apparatus is shown in a configuration where the paddle is not expanded (e.g., folded) and can be delivered (e.g., inserted) into the body, such as through a 10 - mm port. The spacing between the surface electrodes 433 is minimal, e.g., about 2.5 mm. In Figure 4B, the apparatus can be positioned near the target tissue by articulating the joint region 409 such that, for example, the side of the paddle with the surface electrodes is adjacent to the target tissue. Once positioned, the paddle region can be expanded so that the surface electrodes are separated by a desired distance 433' (e.g., in Figure 4B, the two outer electrodes are about 11 mm apart). Figure 4C shows the configuration with the three - electrode design of Figures 4A - 4B fully expanded, where the maximum spacing between the surface electrodes is 433''. For example, in Figure 4C, the maximum spacing between each electrode is about 10 mm and the total separation between the outer electrodes is 20 mm. Any of the apparatuses described herein may include a sensor or gauge integrated into the apparatus to specify the actual spacing of the electrodes, thereby enabling accurate voltage or power application and setting. In some examples, the apparatus may incorporate a linear potentiometer. Also, in some embodiments, the electrodes may include, for example, suction ports for applying a vacuum around the electrodes.

[0087] Figures 4D - 4F show an example of the back (Figs. 4D and 4F) and side (Fig. 4E) of the device of Figs. 4A - 4C, and show one mechanism for expanding and contracting the paddle region. For example, Fig. 4D shows a rear view of the distal end region of the device including the paddle region 411, and in Fig. 4D, the paddle region is shown in a folded (not expanded) configuration. In this configuration, it can be easily inserted into the body through the port. The paddle region includes a hinged frame that can expand outward to separate the outer surface electrodes when the central member 436 is advanced distally, as shown in Fig. 4F. The central member may be driven distally or proximally by a cable or rod and coupled to a handle to adjust the spacing between the electrodes. Fig. 4E is a side view of the device of Figs. 4A - 4D. Fig. 4F is a rear view of the partially expanded paddle region (similar to the front view shown in Fig. 4B).

[0088] Figs. 5A - 5C show different views of the device 400 of Figs. 4A - 4F, where the paddle region 411 includes three non - penetrating (e.g., surface) electrodes 413, 413’, 413’’, and the spacing between them can be adjusted. In Fig. 5A, the paddle region 411 is shown in a state where it is articulated 90 degrees “downward”, and in Fig. 5B, the paddle region 411 is shown in a state where it is articulated 90 degrees “upward”.

[0089] Fig. 6 shows another example of the device 600 described in this document, where one or more contact electrodes are arranged on each of a pair of articulating jaws. In Fig. 6, the device includes a first (e.g., upper) arm 625 and a second (lower) arm 625’ configured to operate to open and close in parallel as shown. These arms may also be referred to as “jaws”. The embodiment shown in Fig. 6 provides surface electrodes on the lateral sides 615, 615’ of each arm such that these electrodes face laterally, and / or the electrodes can be arranged on the inner surfaces 617, 617’ to hold tissue between the arms and press it against the surface electrodes in a clamp - type configuration.

[0090] In the example shown in FIG. 6, there are electrodes on surfaces 617 and 617', and the device is configured to clamp tissue such that the tissue is held between the arms or jaws. By the force with which the tissue is held in the jaws, the tissue is fixed in position and, in some examples, the arc suppression layer of the contact electrode can be deflected relative to the electrode surface, as described with reference to FIG. 2H. In some embodiments, the electrodes are disposed on both the inner surfaces 617, 617' and also the side surfaces 615, 615', and in use, only the appropriate electrode set is selectively activated as required, for example to apply any electrotherapy between the side electrodes or between the "clamp" electrodes, depending on the user's preference and / or the composition and location of the target tissue. Thus, any of these applicators can include a switch that multiplexes between one or more electrode sets on the applicator.

[0091] Figures 7A and 7B show alternative examples of an arm or jaw that can be used with the device of the present disclosure. In Figure 7A, the device includes a curved or bent jaw 725. Figure 7B shows an example of a cross-section of the curved jaw of Figure 7A, which includes an electrode 705 having a rounded corner / edge 706 (e.g., a fillet) on the tissue contact surface 745, and may also include a rounded edge 706' on the edge / surface that does not contact the tissue. The rounded edge 706' that does not contact or face the tissue can also reduce the peak electric field and prevent arc discharge from this (e.g., lower) edge. By adding rounded edges / corners, depending on the type of tissue, for example, the peak electric field can be reduced by 15% - 30%, 20% - 25%. The radius of curvature of the rounded edge (fillet) can be any value. For example, when the thickness of the electrode is t, the radius of curvature can be greater than about t / 8 (e.g., greater than about t / 7, greater than about t / 6, greater than about t / 5, greater than about t / 4, greater than about t / 3, between about t / 8 and about 4t, between about t / 8 and about 2t, etc.). For example, in some devices, the radius of curvature of the curved edge (fillet) can be about 0.1 mm to 0.5 mm for a particular dimension of the electrode. The electrode in this example is fixed within an electrically insulating material 707 that forms the base.

[0092] Figures 8A - 8D illustrate another embodiment of the clamp applicator device 800. In this example, the clamp device is configured to treat tissue such as the vocal cords / vocal folds. The device includes an upper (distal) clamp jaw 825 and a lower (proximal) clamp jaw 825'. In this example, the upper jaw 825 moves proximally from the distal end as shown by arrow 840 (FIG. 8B) along the longitudinal axis (major axis) of the device and adjusts the jaw opening to hold the tissue. In different embodiments, instead of the distal jaw, the proximal jaw may move relative to the distal jaw, or each jaw may be movable relative to each other. The contact electrodes 813 are shown disposed on the inner surfaces of the jaws 825, 825' to contact the target tissue to be treated. The contact electrodes 813 of the upper / lower clamp jaws are shown in FIG. 8D. FIGS. 8B and 8C show the jaws of the device in the open state (FIG. 8B) and the closed state (FIG. 8C). In practice, the jaws can be clamped onto the tissue to apply treatment therebetween. In some examples, the device may include an articulation region (articulation joint) as described above. The elongate body may be configured as a cannula as described with reference to FIGS. 3A - 3E and 4A - 4F. In some further examples, various features of the devices of FIGS. 6 and / or 7A - 7B may be combined with and incorporated into the example of FIGS. 8A - D.

[0093] In any of these devices, a rotation control unit (e.g., a rotation knob) 860 may be included that is configured to rotate the clamp without rotating the handle 850 (e.g., by rotating only the elongated body and / or the distal end clamp or paddle region). The handle 850 may also include a control unit 853 for operating the clamp jaw and / or controlling the clamp of the device. In some examples, the handle may include a plunger and / or a latch for operating / controlling the clamp. The control unit 853 in FIG. 8A is shown as a clamp slide and can be used to incorporate a sensor or gauge for specifying the distance between the electrodes. Generally, any of the devices described herein may include a sensor or gauge configured to specify the distance between the electrodes. The output of this sensor or gauge is passed to a controller (e.g., a control unit 144 (see, e.g., FIG. 1) on or within the pulse generator), and in some embodiments, the output of the sensor may enable the system to automatically set treatment parameters based on the distance between the jaw and / or the electrodes. In some examples, the device may incorporate a linear potentiometer. In variations where the device includes a joint joint, the device may further include a joint control unit (not shown).

[0094] FIG. 8B is a side view of the jaw assembly of the device 800. In this example, the jaw can be opened (e.g., up to 25 mm or more, if necessary). As described above, the device may include joints similar to those shown in FIGS. 3A - 3E. The examples described herein may include contact electrodes or surface electrodes, but in some embodiments, these devices may be configured to be used with needle electrodes, wire electrodes, etc.

[0095] FIG. 9A shows another example of a clamping device 900 that includes a pair of jaws (upper or distal jaw 925 and lower or proximal jaw 925'). In the device of this example, there is a first contact electrode 905 inside the distal jaw and a second electrode on the opposite side of the proximal jaw (not visible in FIG. 9). The opening diameter of the jaws can be adjusted, for example, by controlling the handle, for example, by moving the proximal jaw proximally or distally, or by moving the distal jaw axially relative to the proximal jaw.

[0096] Figure 9B shows another example of the clamp device 900, which has substantially parallel jaws arranged at an angle (e.g., 90 degrees / vertical) with respect to the shaft of the device, but the distal and proximal jaws 925, 925' of the clamp device have a shape similar to the bent or curved jaws 725 of FIG. 7A. Also, the electrode 905 of FIG. 9B has rounded edges / corners 906 (similar to the rounded edges 706, 706' of FIG. 7) to reduce or prevent arc discharge, as described with reference to FIG. 7B. In this example, all electrode edges have rounded corners, but in some embodiments, the rounded corners / edges may be only at the tissue contact surface of the electrode or its periphery. The electrode 905 of this example is arranged to clamp tissue therebetween and is disposed inside each jaw, protruding inward (e.g., 1 mm, 2 mm, 3 mm) from each jaw 925, 925' as seen in FIG. 9B. Similar to FIG. 7B, the electrode 905 may be fixed within the electrically insulating material forming the base of each jaw. The spacing between the jaws, and thus the spacing between the electrodes, can be adjusted, for example, by control of the handle, e.g., by moving the proximal jaw proximally or distally. For example, the proximal jaw may be spring-loaded. Similar to other embodiments, the jaws 925, 925' may have surface electrodes (not shown) on the lateral sides of each jaw, and such lateral side electrodes can be used as side-facing electrodes (similar to those shown in FIG. 6). Such side-facing electrodes can be provided, for example, in addition to the inner tissue clamping electrodes 905, and the device 900 may include control of the spacing between the side-facing electrodes in addition to control of the spacing between the clamping electrodes. Also, similar to other embodiments, the device may be configured to detect the spacing between the electrodes and send such spacing information to the control of the pulse generation system to adjust one or more parameters of the pulse. The examples of FIGS. 9A - 9B may be particularly useful for the treatment of cardiac arrhythmias, such as atrial fibrillation. For example, by slightly curving or bending the jaws, the right and left pulmonary veins can be separated or other atrial lesions can be created to prevent atrial fibrillation.The device of the present disclosure can provide a faster, more effective, and robust treatment for atrial fibrillation, and such treatment can be implemented with a single device.

[0097] As described above, the applicator having the contact electrodes of the present disclosure can be configured to reduce or prevent arc discharge. FIG. 10A shows an example of a contact electrode with an additional arc suppression function. In FIG. 10A, the contact electrode 1005 includes an electrode surface 1008 (the exposed or open surface of the electrode). The electrode 1005 is supported, for example, by an electrical insulating material 1007 on all surfaces other than the electrode surface 1008. A flexible arc suppression layer 1015 is disposed on the electrode surface 1008, and there is a gap region 1017 between the arc suppression layer and the electrode surface. FIGS. 10B-10E show alternative configurations of the contact electrode. In FIG. 10B, the contact electrode (e.g., a stainless steel electrode) 1005 is supported (and partially surrounded) by an insulating support 1007. The outer surface 1008 of the electrode 1005 is covered with an arc suppression layer 1015. FIG. 10C shows an example of a contact electrode 1005 having a rounded edge 1006 (e.g., a fillet) on the outer or exposed electrode surface 1008 to prevent arc discharge. FIG. 10D shows an example of a cross-section of a contact electrode similar to that shown in FIG. 10A, including an electrode surface 1008 on the electrode 1005 separated from the arc suppression layer 1015 by an air gap 1017. FIG. 10E shows another cross-section, e.g., a longitudinal cross-section, of the electrode of FIG. 10D, showing an electrical connection portion 1033 that can be connected to a wire or conductive material for electrical connection to a pulse generator.

[0098] FIG. 11 is a diagram showing an example of a model of a parallel jaw having two contact electrodes similar to those shown in FIGS. 9 and 10A, and shows an exemplary cross-section of the jaw when clamping a target tissue 1144 (e.g., heart tissue in this model). The shape shown in FIG. 11 is used to model the electric field as will be described later, and based on the obtained electric field distribution, it has been shown that the possibility of arc discharge is significantly reduced. In FIG. 11, the model includes a first electrode 1105 and a second electrode 1105'. The first electrode 1105 and the second electrode 1105' are each covered by arc suppression layers 1115, 1115', and usually, the arc suppression layers are separated from the electrode surfaces by respective air gaps 1117, 1117'. In FIG. 11, the jaw is clamping the sample tissue 1144, and the arc suppression layers 1115, 1115' are pressed against the electrode surfaces where the tissue is clamped, while the air gaps 1117, 1117' remain over the unclamped regions. In the example shown in FIG. 11, the jaw is closed over the tissue, and the opposing semiconductor layers 1115, 1115' (including regions not in contact with the target tissue) do not contact each other and are separated by blood or air 1146.

[0099] The devices described herein including a clamp applicator as shown in FIGS. 8A, 9B, and 11 can be used to treat heart tissue such as the pulmonary veins. For example, these devices can be used as part of a bilateral pulmonary vein isolation (without atriotomy) during minimally invasive aortic valve replacement or the maze procedure for treating atrial fibrillation. The right pulmonary vein can be ablated by applying a sub-microsecond pulse as described herein from a clamp such as the device shown in FIG. 9B or FIG. 11. The device can also be introduced into the oblique sinus under the aorta to ablate the left pulmonary vein. These devices offer many advantages in cardiac applications as described above. Further, by using a sub-microsecond pulsed electric field in combination with the configuration of the disclosed devices, it is possible to safely treat (e.g., ablate) near blood vessels and valves.

[0100] Figures 12A - 12B, 13A - 13B, and 14A - 14C show examples of simulated electric fields when high - voltage energy such as sub - microsecond pulses is applied between the jaws of the applicator tool of the present disclosure. In Figures 12A - 12B, for the electric field, when air is between the jaws (Figure 12A) or blood is between the jaws (Figure 12B) and the electric field is applied, the conductivity of the arc suppression layer is simulated to be about 0.1 times that of the target tissue (e.g., heart tissue). As shown, the resulting electric field is highest in the region 1208 where the contact between the arc suppression layer and the tissue is greatest (where the arc suppression layer has displaced the air gap), and drops sharply where the air gap remains 1212. In Figures 13A - 13B, for the electric field, when air is between the jaws (Figure 13A) or blood is between the jaws (Figure 13B), the conductivity of the arc suppression layer is simulated to be approximately the same as that of the target tissue (e.g., heart tissue). In the simulation, in both cases, a region of high electric field is seen in the space 1316 between the electrode and the inside of the tissue's arc suppression layer, but since this region is inside the air gap between the arc suppression layer and the electrode surface, there is no risk of arc discharge. In Figure 13A, a small separation 1314 between the arc suppression layer and the tissue also shows a larger electric field in air but not in blood (Figure 13B).

[0101] In Figures 14A - 14B, for the electric field, when air is between the jaws (Figure 14A) or blood is between the jaws (Figure 14B) and a 5 kV electric field is applied, the conductivity of the arc suppression layer is simulated to be about 10 times that of the target tissue (e.g., heart tissue). In the simulation, when air (not blood) is between the jaws, a significant electric field occurs in the region 1416 between the jaws that does not contain tissue. Any of the devices described in this document can be configured to minimize or eliminate this gap region, particularly the gap between the tissue and the arc suppression layer.

[0102] FIG. 15 shows a model of a parallel joe having two contact electrodes similar to those shown in FIG. 11. However, in FIG. 15, when the joe is closed, the arc suppression layers that are not in contact with the tissue contact each other (except for the small transition region 1546). This device may be configured to minimize or eliminate the transition region 1546 such that the tissue contacts the arc suppression layer completely or almost completely. For example, the arc suppression layer may be formed of a compliant (e.g., very flexible) material and / or may have a thickness that provides a greater degree of flexibility. The gap region 1517 may be larger (e.g., more than half, 55% or more, 60% or more, 70% or more, 80% or more of the uncompressed thickness of the tissue) so as to be able to clamp a large-thickness tissue therebetween.

[0103] In FIG. 15, the model includes a first electrode 1505 and a second electrode 1505'. The first electrode 1505 and the second electrode 1505' are each covered by arc suppression layers 1515, 1515', and typically the arc suppression layers are spaced from the electrode surfaces by respective air gaps 1517, 1517'. In FIG. 15, the joe is clamping the sample tissue 1544, and each arc suppression layer 1515, 1515' is pressed against the electrode surface where the tissue is clamped, while the air gaps 1517, 1517' remain over the unclamped regions. In the example shown in FIG. 15, the joe is closed over the tissue, and the opposing semiconductor layers 1515, 1515' in the region not in contact with the target tissue contact each other except for a very small transition gap 1546. As described above, the device may be configured to minimize or eliminate this transition gap 1546.

[0104] Figures 16A - 16B, 17A - 17B, and 18A - 18B show the simulation results of the electric field based on the applicator configuration of FIG. 15. In FIGS. 16A - 16B, for the case where there is air between the jaws (FIG. 16A) or blood between the jaws (FIG. 16B), the conductivity of the arc suppression layer is simulated to be about 0.1 times that of the target tissue (e.g., heart tissue). As shown, the resulting electric field is highest in the region 1608 with the highest contact and drops sharply at 1612 where an air gap remains. In FIGS. 17A - 17B, for the case where there is air between the jaws (FIG. 17A) or blood between the jaws (FIG. 17B), the conductivity of the arc suppression layer is simulated to be approximately the same as that of the target tissue (e.g., heart tissue). As in FIGS. 13A - 13B (related to the model of FIG. 11), the simulation shows a region 1714 of high electric field within the air gap of the electrode assembly in both cases, but no arc discharge occurs in this internal region.

[0105] In FIGS. 18A - 18B, for the case where there is air between the jaws (FIG. 18A) or blood between the jaws (FIG. 18B), the conductivity of the arc suppression layer is simulated to be about 10 times that of the target tissue (e.g., heart tissue). In the simulation, when there is air (instead of blood) between the jaws, a large electric field 1816 is generated between the small non - contact regions between the arc suppression layers.

[0106] The simulation data shown in FIGS. 11 to 18B suggests that it may be beneficial to select the conductivity of the arc suppression layer (e.g., the intermediate conductive layer) to be within one order of magnitude of the expected conductivity of the tissue to be treated. For example, in any of these devices, the conductivity of the arc suppression layer can have a conductivity that is 0.1 to 10 times the expected conductivity of the tissue (e.g., less than 10 times the expected conductivity of the tissue, less than 5 times the expected conductivity of the tissue, less than 3 times the expected conductivity of the tissue, less than 2 times the expected conductivity of the tissue, approximately the same as the expected conductivity of the tissue, less than the expected conductivity of the tissue, less than 0.9 times the expected conductivity of the tissue, less than 0.8 times the expected conductivity of the tissue, less than 0.7 times the expected conductivity of the tissue, less than 0.6 times the expected conductivity of the tissue, less than 0.5 times the expected conductivity of the tissue, less than 0.4 times the expected conductivity of the tissue, less than 0.3 times the expected conductivity of the tissue, less than 0.2 times the expected conductivity of the tissue, less than 0.1 times the expected conductivity of the tissue, less than 0.09 times the expected conductivity of the tissue, etc.).

[0107] In the experiments using the applicator device described in this document, it was shown that the sample tissue was reliably processed in all of these configurations. By similar experiments, it was shown that the arc discharges that sometimes occur with the exposed electrodes without the arc suppression layer are completely eliminated by using the arc suppression electrodes, both when there is a gap and when there is no gap between the arc suppression electrode and the electrode surface.

[0108] Treatment method As described above, any of these devices can be used for treating tissue and are particularly useful when at least a part of the electrode may be exposed to air or blood during treatment. In particular, these methods can be used as part of a laparoscopic surgery for treating tissue.

[0109] For example, using a device having a non-penetrating (e.g., surface) electrode described herein, it can be brought into contact with tissues of the female urogenital or genital system (e.g., ovaries, fallopian tubes, and pelvic inner tissues). For example, the device comprises a paddle region including the electrodes described herein and can be used for the treatment of endometriosis. The device is inserted (and in some examples expanded) into the body and pressed against the tissue affected by endometriosis. In some examples, suction can be used to fix the surface electrode to the target tissue.

[0110] In some examples, the surface electrodes described herein can be used to treat various conditions by contacting, for example, one or more lesions (e.g., tumors such as nodules, polyps, and / or cysts) on the vocal folds (e.g., vocal cords). For example, a device configured as a paddle region including the surface electrodes described herein can be inserted into a patient (e.g., through the mouth or via an incision) to approach the vocal cords / vocal folds. In some examples, the paddle region can be expanded and pressed against the tissue of the vocal cords to treat vocal cord lesions. In some examples, the target tissue (vocal cords / vocal folds) can be clamped between two or more surface electrodes as described. One or more treatments can be applied. These methods can also be used for the treatment of laryngeal papillomas and other skin lesions and conditions.

[0111] The devices described herein can also be used for the treatment of heart tissue. For example, the applicator described herein can be inserted through the vasculature and used to clamp or otherwise fix to heart tissue, for example, to treat atrial fibrillation among many heart diseases.

[0112] Other indications can include the treatment of skin lesions, internal tumors of organs, treatment of tubes including blood vessels, ducts, and intestines, treatment of eyelids, lips, tongue, ureters, urethra, gallbladder, ducts, bile ducts, lymph nodes, rectum, esophagus, heart, liver, intestine, stomach, pancreas, lungs, uterus, fallopian tubes, fingers, ears, nose, any blood vessels, spleen, kidneys, etc. For example, the clamping device described herein can be used to treat any tissue that fits between, for example, Joe's.

[0113] In particular, these devices may be particularly suitable for the treatment of indications where a larger treatment area is desired, and as described herein, when the electrodes are configured to include rounded edges (e.g., fillets) and / or arc suppression layers, there is no need to worry about arc discharge even if the surface electrodes are made relatively long.

[0114] Any of the methods (including user interfaces) described herein can be implemented as software, hardware, or firmware, and may be described as a non-transitory computer-readable storage medium storing a series of instructions executable by a processor (e.g., a computer, tablet, smartphone, etc.), and when this series of instructions is executed by the processor, it causes the processor to perform, without limitation, steps including display, communication with the user, analysis, change of parameters (including timing, frequency, intensity, etc.), decision-making, warning, etc.

[0115] It should be understood that all combinations of the foregoing concepts and additional concepts described in more detail below (provided that these concepts are not mutually contradictory) are part of the subject matter of the invention disclosed herein and can be used to achieve the advantages described herein.

[0116] As used herein, when a feature or element is referred to as being "above" another feature or element, it may be immediately above the other feature or element, or intervening features and / or elements may be present. In contrast, when a feature or element is expressed as being "immediately above" another feature or element, there are no intervening features or elements therebetween. Also, when a feature or element is referred to as being "connected to", "attached to", or "coupled to" another feature or element, it will be understood that it may be directly connected, attached, or coupled to the other feature or element, or intervening features and / or elements may be present. In contrast, when a feature or element is referred to as being "directly connected", "directly attached", or "directly coupled" to another feature or element, there are no intervening features or elements. Although described or illustrated with respect to one embodiment, the features and elements so described or illustrated can also be applied to other embodiments. Also, it will be understood by those skilled in the art that references to a structure or feature being "adjacent to" another feature may have portions that overlap or are beneath the adjacent feature.

[0117] The terms used herein are for the purpose of describing particular embodiments only and are not intended to be limiting of the invention. For example, as used herein, the singular forms "a", "an", and "the" are intended to include the plural forms as well, unless the context clearly indicates otherwise. As used herein, the terms "comprising" and / or "comprises" specify the presence of the stated features, steps, operations, elements, and / or components, but do not preclude the presence or addition of one or more other features, steps, operations, elements, components, and / or groups thereof. It will be further understood that, as used herein, the term "and / or" includes any and all combinations of one or more of the associated listed items, and may sometimes be abbreviated as " / ".

[0118] In this specification, for the purpose of facilitating the description of the relationship between one element or feature and another element or feature, spatially relative terms such as "under", "below", "lower", "over", "upper", etc. may be used as illustrated. It will be understood that spatially relative terms are intended to encompass various directions of the device during use or operation in addition to the directions depicted in the figures. For example, if the device in the figure is inverted, an element described as being "under" or "directly under" another element or feature will be located "above" the other element or feature. Thus, the exemplary term "under" can encompass both upward and downward directions. The device may be in other orientations (90-degree rotations or other orientations), and the spatially relative descriptions used in this specification are to be interpreted accordingly. Similarly, terms such as "upward", "downward", "vertical", "horizontal", etc. are used in this specification for illustrative purposes only, unless otherwise specified.

[0119] In this specification, the terms "first" and "second" may be used to describe various features / elements (including steps), but these features / elements should not be limited by these terms unless otherwise indicated by the context. These terms may be used to distinguish one feature / element from another. Thus, the first feature / element described hereinafter may be referred to as the second feature / element, and similarly, without departing from the teachings of the present invention, the second feature / element described hereinafter may also be referred to as the first feature / element.

[0120] Throughout this specification and the following claims, unless the context otherwise requires, the word "comprise", and variations such as "comprises" or "comprising", mean that various components can be used jointly in methods and articles (e.g., compositions and devices including apparatuses and methods). For example, the term "comprising" is understood to mean including the recited element or step but not excluding other elements or steps.

[0121] In general, the devices and methods described herein are to be understood as being inclusive, but all or subsets of components and / or steps may alternatively be exclusive and may be expressed as "comprising" or alternatively "consisting essentially of" various components, steps, sub-components or sub-steps.

[0122] As used in this specification and the claims, including when used in the examples, unless specifically stated otherwise, all numerical values should be read as being preceded by the term "about" or "approximately" even if the term is not explicitly written. When describing size and / or position, the expression "about" or "approx." may be used to indicate that the stated value and / or position is within a reasonable expected range of values and / or positions. For example, a numerical value may have a value of ±0.1% of the stated value (or numerical range), ±1% of the stated value (or numerical range), ±2% of the stated value (or numerical range), ±5% of the stated value (or numerical range), ±10% of the stated value (or numerical range), etc. Numerical values shown in this specification should be understood to include an approximate range or approximation of that value, unless the context indicates otherwise. For example, if the value "10" is disclosed, the value "about 10" is also disclosed. The numerical ranges described in this specification are intended to include all sub-ranges subsumed therein. Also, when a value is disclosed, it should be understood that values "less than the value", "greater than the value", and possible ranges between the values are also disclosed, as would be appropriately understood by a person skilled in the art. For example, if the value "X" is disclosed, not only "less than X" but also "greater than X" (e.g., if X is a numerical value) is disclosed. Also, throughout this application, it should be understood that data is provided in many different formats and this data represents ranges of endpoints and starting points, and any combination of data points. For example, if a particular data point "10" and a particular data point "15" are disclosed, it should be understood that not only between 10 and 15, but also greater than 10, greater than or equal to 10, less than 10, less than or equal to 10, and between 10 and 15 are disclosed. It should also be understood that each unit between two particular units is also disclosed. For example, if 10 and 15 are disclosed, 11, 12, 13, 14 are also disclosed.

[0123] Although the above describes various exemplary embodiments, many modifications can be made to the various embodiments without departing from the scope of the invention as recited in the claims. For example, in alternative embodiments, the order in which the various described method steps are performed may often be changed, and in other alternative embodiments, one or more method steps may be completely skipped. Optional features of the various apparatus and system embodiments may or may not be included in a particular embodiment. Accordingly, the foregoing description is provided primarily for illustrative purposes and should not be construed as limiting the scope of the invention as recited in the claims.

[0124] The examples and figures included herein are illustrative and not restrictive, showing specific embodiments in which the subject matter can be practiced. As previously mentioned, other embodiments can be utilized and derived therefrom, and thus structural and logical substitutions and changes can be made without departing from the scope of the present disclosure. Such embodiments of the subject matter of the present invention may, for convenience only, be referred to herein individually or collectively by the term "invention," but there is no intent to voluntarily limit the scope of this application to any single invention or inventive concept, even if more than one invention is actually disclosed. Thus, while specific embodiments are illustrated and described herein, any configuration calculated to achieve the same purpose may be used in place of the specific embodiments illustrated. The present disclosure is intended to cover any adaptations or variations of the various embodiments. Combinations of the above embodiments, and other embodiments not specifically described herein, will be apparent to those skilled in the art upon review of the above description.

[0125] All publications and patent applications mentioned herein are hereby incorporated by reference in their entirety to the same extent as if each individual publication or patent application was specifically and individually indicated to be incorporated by reference.

Claims

1. An electrode device configured to limit arc discharge, comprising: a first electrical insulator; a first electrode supported by the first electrical insulator and including a first electrode surface; a second electrode supported by the first electrical insulator or a second electrical insulator and including a second electrode surface; the first electrode and the second electrode are configured to allow an electrical pulse having a magnitude of at least 0.1 kV to pass therebetween; the device further includes a first arc suppression layer disposed between the first electrode and the second electrode and configured to reduce or eliminate arc discharge between the first electrode and the second electrode when allowing the electrical pulse to pass, the first arc suppression layer being formed of a semiconductor material having a conductivity lower than that of the first electrode surface.

2. The electrode device according to claim 1, wherein the conductivity of the arc suppression layer is from about 0.001 S / m to about 20 S / m.

3. The device according to claim 1, wherein the first arc suppression layer is fixed to, mounted on, covers at least a part of, or completely covers the first electrode surface.

4. The device according to any one of claims 1 to 3, wherein the first electrode and the second electrode are non-through electrodes or plate electrodes.

5. The device according to any one of claims 1 to 3, wherein the first electrode is on a lateral side of a first jaw, the second electrode is on a lateral side of a second jaw, and the lateral side of the first jaw is in the same plane as the lateral side of the second jaw.

6. The device according to any one of claims 1 to 3, wherein the first electrode is on a first side of a first jaw, the second electrode is on a second side of a second jaw, and the first side of the first jaw and the second side of the second jaw are configured to fix a tissue to be treated therebetween.

7. The device according to claim 6, further including an elongated shaft, wherein the first jaw and the second jaw are disposed at an angle with respect to the shaft and have a curved or bent configuration. **Claim 8**: Further, a third electrode is provided on the side of the first jaw, and a fourth electrode is provided on the side of the second jaw, the side of the first jaw being in the same plane as the side of the second jaw, and the apparatus being configured to selectively activate the first electrode and the second electrode, or the third electrode and the fourth electrode. The apparatus according to claim 6. **Claim 9** The first jaw and the second jaw are configured to open and close such that the first electrode and the second electrode remain parallel to each other. The apparatus according to claim 6. **Claim 10** The first jaw and the second jaw are configured to move relative to each other in the axial direction. The apparatus according to claim 6. **Claim 11** The first electrode and the second electrode are separated by a certain distance. The apparatus according to any one of claims 1 to 3. **Claim 12** The arc suppression layer is formed of a doped or otherwise treated polymer material containing a conductive material. The apparatus according to any one of claims 1 to 3. **Claim 13** The polymer material includes a silicone polymer, and the doping material includes carbon. The apparatus according to claim 12. **Claim 14** The apparatus has an air gap between the first arc suppression layer and the surface of the first electrode when not in operation. The apparatus according to any one of claims 1 to 3. **Claim 15** When a force is applied to the first arc suppression layer, the first arc suppression layer is configured to deflect with respect to the surface of the first electrode. The apparatus according to any one of claims 1 to 3. **Claim 16** The apparatus has a first gap region between the first arc suppression layer and the surface of the first electrode when not in operation, and the first gap region is 0.5 mm or more. The apparatus according to any one of claims 1 to 3. **Claim 17** The first electrode and the second electrode each have a rounded edge. The apparatus according to claims 1 to 3. **Claim 18** The first electrode and the second electrode each have a length exceeding 5 mm. The apparatus according to any one of claims 1 to 3. **Claim 19** The first arc suppression layer comprises a flexible film or coating. The apparatus according to any one of claims 1 to 3. **Claim 20** The first arc suppression layer has a conductivity of 0.01 S / m to 10 S / m. The apparatus according to any one of claims 1 to 3. **Claim 21** The device according to any one of claims 1 to 3, further comprising one or more suction ports configured to apply suction to aspirate tissue against at least one or both of the first electrode and the second electrode.

22. The device according to any one of claims 1 to 3, wherein the first and second electrodes are configured to pass an electrical pulse having a duration of less than 1000 nanoseconds.

23. The device according to any one of claims 1 to 3, wherein the device comprises a paddle region extending distally from an elongate body, and the first and second electrodes are on the paddle region.

24. The device according to claim 23, comprising an articulation region connecting the elongate body to the paddle region, the articulation region being configured to articulate the paddle region in a plane extending through the elongate body.

25. The device according to claim 23, wherein the paddle region is configured to expand in the width direction to increase the spacing between the first and second electrodes.

26. An electrode device configured to suppress arc discharge, a first jaw and a second jaw configured to open and close to fix the tissue to be treated therebetween, a first electrode supported by the first jaw, and a second electrode supported by the second jaw, wherein the first electrode and the second electrode are configured to pass an electrical pulse having a magnitude of at least 0.1 kV, and the device further comprises a first arc suppression layer and a second arc suppression layer disposed between the first electrode and the second electrode and configured to reduce or eliminate arc discharge between the first electrode and the second electrode when the electrical pulse passes therethrough, the first and second arc suppression layers being formed of a semiconductor material having a conductivity lower than the conductivity of each of the first and second electrodes.

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