Clamp electrodes forming gripping surfaces

Abstract

Apparatuses for delivering pulsed electrical energy are disclosed. These apparatuses include clamping apparatuses with a first and second jaws comprising one or more electrodes. The electrodes comprise or form a tissue-gripping surface. Methods of forming apparatuses of the present disclosure having conductive grip, as well as methods of applying pulsed electrical energy using these apparatuses are also disclosed.

Description

CLAMP ELECTRODES FORMING GRIPPING SURFACESCLAIM OF PRIORITY

[0001] This patent application claims priority to U.S. Provisional Patent Application No. 63 / 668,744, titled “CLAMP ELECTRODES FORMING GRIPPING SURFACES,” filed on July 8, 2024, which is herein incorporated by reference in its entirety.BACKGROUND

[0002] Electrosurgical procedures may apply electrical energy between the jaws of a surgical tool in order to treat tissue. For example, electrosurgical treatments may be used to ablate tissue, including, in some examples, cardiac tissue. For example, an electrosurgical device may apply electrical energy to treat a cardiac disorder such as atrial fibrillation or other heart arrhythmia. Ablation of cardiac tissue may be useful to create scar tissue that may interrupt the path of errant electrical impulses in the heart tissue. Although ablation has been proposed using a variety of thermal techniques, such as freezing via cryogenic probe, heating via radio frequency (RF) energy, surgical cutting, and other techniques, it may be particularly helpful to use very short, relatively high energy pulses, such as microsecond or submicrosecond pulses to ablate the tissue.

[0003] However, it may be difficult to hold and secure the tissue when performing these procedures. In some cases, it may be difficult to secure the tissue, which may be slippery and irregularly shaped, while maintaining sufficient contact with the electrodes without arcing, particularly when applying high field- strength pulses. In particular, it may be difficult to prevent arcing and / or achieve consistent ablation when using devices having electrodes configured to be positioned on opposite sides of the tissue, such as (but not limited to) electrodes in opposing jaws, including scissoring jaws and / or parallel jaws. Although the jaws of the applicator may be gripping, existing gripping surfaces may require relatively small electrode surface and may damage the tissue being treated.

[0004] Thus, it would be helpful to provide methods and apparatuses for treating a tissue using apparatuses that address these deficiencies.SUMMARY OF THE DISCLOSURE

[0005] The present disclosure includes various improvements which may enhance the construction, operation, and methods of use of surgical devices for ablating tissue, such as (but not limited to) cardiac tissue. The methods and apparatuses described herein may include applicators including electrodes for delivering energy to tissue.

[0006] In general, the apparatuses described herein may include a pair of jaws for holding tissue that include electrodes for the application of electrical energy to tissue held by the jaws. The electrodes on the jaws are configured to grip the tissue held by the jaws. In some cases, the electrodes include a gripping surface. It may be particularly beneficial to have the gripping surface be formed by the electrodes. The gripping surfaces may therefore make electrical contact with the tissue, while keeping a relatively constant separation between the electrodes on either jaw when engaged with tissue.

[0007] In some examples the electrodes may be formed of a length of wire extending along at least a portion of the length of each jaw. For example, the electrode(s) may be formed by an exposed elongate length of wire, e.g., having a length of greater than 2x, 3x, 4x, 5x, 6x, 7x, 8x, 9x, lOx, etc. the width of the wire. In some cases, the electrodes may be formed from a conductive mesh. In some cases, the electrodes may be formed of an electrode surface (e.g., plate) that has one or a plurality of protrusions into or out of the electrode surface.

[0008] Thus, as described herein, an apparatus, (e.g., a clamping apparatus) for delivering pulsed electrical energy may include: a first jaw; a first electrode on the first jaw, wherein the first electrode comprises a first tissue-gripping surface; a second jaw that is opposite from the first jaw; a second electrode on the second jaw; an actuator configured to adjust a separation between the first jaw and the second jaw; and a connector at a proximal end of the apparatus configured to form an electrical connection between a pulse generator and the first and second electrodes. The second electrode may comprise a second tissue-gripping surface. The first electrode may comprise an elongate wire electrode extending along at least a portion of a length of the first jaw to form the first tissue-gripping surface. For example, the elongate wire may extend back and forth along the full or a portion of a length of the first jaw in two or more adjacent lines. Either or both tissue-gripping surfaces may have an adjustable size. For example, the first and / or the second tissue-gripping surface may comprise multiple stacked lengths of the elongate wire configured to be converted into a single layer of the lengths of the elongate wire based on a pressure applied by the first and / or second jaws against a tissue and / or against each other.

[0009] The first electrode may comprise an electrically conductive mesh extending over at least a portion of a surface of the first jaw to form the first tissue-gripping surface. The first electrode may comprise one or more first tissue grips configured to extend into, or from, a tissue-contacting surface of the first electrode, so that the tissue-contacting surface of the first electrode surrounds the one or more first tissue grips. The second electrode may comprise one or more second tissue grips configured to extend into, or from, a tissue-contacting surface ofthe second electrode, so that the tissue-contacting surface of the second electrode surrounds the one or more second tissue grips. In some examples the one or more second tissue grips may be configured to mate in a female-to-male engagement, a male-to-male engagement, or a female-to-female engagement with the one or more first tissue grips.

[0010] The first jaw and the second jaw may extend in a curved length. The first jaw and the second jaw may be configured to open and close substantially in parallel. The connector may be configured to connect to a pulse generator configured to deliver sub-microsecond electrical pulses having an amplitude of at least 0.1 kV. Any of these apparatuses may include the pulse generator.

[0011] As mentioned above, in some cases the apparatus may be configured so that the electrodes are formed from one or more lengths of wire that are arranged against the tissuefacing side of the jaws. These gripping wire electrode(s) may be configured to form a gripping surface to help regain the tissue between the jaws. For example, an apparatus for delivering pulsed electrical energy may include: a first jaw; a first electrode comprising an elongate wire extending along at least a portion of the first jaw, wherein the first electrode is configured to form a first tissue-gripping surface; a second jaw that is opposite from the first jaw; a second electrode on the second jaw; an actuator configured to adjust a separation between the first jaw and the second jaw; and a connector at a proximal end of the apparatus configured to form an electrical connection between a pulse generator and the first and second electrodes. The above apparatus may be referred to as a clamping apparatus or a clamping applicator.

[0012] The second electrode may comprise a second elongate wire extending from the second jaw in a second pattern. The elongate wire may extend along the first jaw along at least a portion of a length of the first jaw (for example, in a first pattern) configured to form the first tissue-gripping surface. For example, the first pattern may be configured so that the elongate wire electrode extends back and forth along at least a portion of a length of the first jaw in two or more adjacent lines.

[0013] The wire forming the electrode may have a curved (e.g., rounded, round, elliptical, etc.) cross-sectional area. For example, the elongate wire electrode may have a rounded cross-sectional profile. The elongate wire electrode may have a diameter of between about 0.5 mm diameter and about 2 mm (e.g., between 0.5 mm and 1.8 mm, etc.). In some cases, the elongate wire electrode has a radius of greater than 0.1 mm (e.g., greater than 0.11 mm, greater than 0.12 mm, greater than 0.2 mm, greater than 0.3 mm, etc.). The elongate wire electrode may have a length that is at least three-fold greater than its diameter (e.g., at least 3mm, at least 4 mm, at least 5 mm, at least 6 mm, at least 7 mm, at least 8 mm, at least 9 mm, at least 10 mm, etc.).

[0014] In any of these examples the second electrode may comprise a second elongate wire electrode arranged on the second jaw to mirror the elongate wire electrode on the first jaw.

[0015] The first jaw and the second jaw may extend in a curved length. The first jaw and the second jaw may be configured to open and close substantially in parallel.

[0016] As mentioned, the connector may be configured to connect to a pulse generator configured to deliver sub-microsecond electrical pulses having an amplitude of at least 0.1 kV.

[0017] For example, an apparatus for delivering pulsed electrical energy may include: a clamping applicator comprising: a first jaw; a first electrode comprising a first elongate wire extending along at least a portion of a length of the first jaw in a first pattern configured to form a first tissue-gripping surface; a second jaw that is opposite from the first jaw; a second elongate wire electrode extending from the second jaw in a second pattern; an actuator configured to adjust a separation between the first jaw and the second jaw; and a connector at a proximal end of the clamping apparatus configured to form an electrical connection between a pulse generator and the first and second electrodes; and the pulse generator, wherein the pulse generator is configured to provide sub-microsecond electrical pulses having an amplitude of at least 0.1 kV.

[0018] Also described herein are apparatuses that include electrodes formed from a mesh that are configured to grip the tissue. For example, a clamping apparatus for delivering pulsed electrical energy may include: a first jaw; a first electrode comprising a first conductive mesh or a grid-like gripping pattern on a tissue-contacting surface of the first jaw, wherein the first conductive mesh or the grid-like gripping pattern is configured to form a first tissue-gripping surface; a second jaw that is opposite from the first jaw; a second electrode on a tissuecontacting surface of the second jaw; an actuator configured to adjust a separation between the first jaw and the second jaw; and a connector at a proximal end of the clamping apparatus configured to form an electrical connection between a pulse generator and the first and second electrodes.

[0019] The mesh or the grid-like gripping pattern forming the electrode(s) may be any appropriate mesh, including a mesh having a square grid pattern, a rectangular grid pattern, a diamond-shaped grid pattern, etc. The mesh may be formed from a plurality of lengths of wire that are woven into the grid pattern; the lengths of wire may be electrically coupled together. The mesh may be formed of a single layer of material, rather than separate orseparable length of wire. The second electrode may comprise a second conductive mesh or a grid-like gripping pattern. The mesh or the grid-like gripping pattern may be formed of any appropriate material that is electrically conductive. For example, the first conductive mesh / grid may comprise a nickel -titanium alloy (e.g., NITINOL). In some cases, the mesh may be formed of silver or an alloy thereof. In some cases, the mesh may be formed of a carbon material. In some cases, the mesh may be formed of a metallic material (e.g., silver, platinum, stainless steel, etc.). The mesh may be coated with a conducive material.

[0020] The first conductive mesh may comprise a lattice having a gap size of less than 1 cm between adjacent strands forming the mesh. In some cases, the first conductive mesh comprises a lattice having a gap size of between 1 cm and 1 mm between adjacent strands forming the mesh.

[0021] As mentioned, the first jaw and the second jaw may extend in a curved length. For example, the first jaw and the second jaw may be configured to open and close substantially in parallel. The configured may be configured to connect to a pulse generator configured to deliver sub-microsecond electrical pulses having an amplitude of at least 0.1 kV.

[0022] For example, an apparatus for delivering pulsed electrical energy may include: a clamping applicator comprising: a first jaw; a first electrode comprising a first conductive mesh or a grid-like gripping pattern on a tissue-contacting surface of the first jaw, wherein the first conductive mesh or a grid-like gripping pattern is configured to form a first tissuegripping surface; a second jaw that is opposite from the first jaw; a second electrode comprising a second conductive mesh or a grid-like gripping pattern on a tissue-contacting surface of the second jaw, wherein the second conductive mesh or a grid-like gripping pattern is configured to form a second tissue-gripping surface; an actuator configured to adjust a separation between the first jaw and the second jaw; and a connector at a proximal end of the clamping apparatus configured to form an electrical connection between a pulse generator and the first and second electrodes; and the pulse generator, wherein the pulse generator is configured to provide sub-microsecond electrical pulses having an amplitude of at least 0.1 kV.

[0023] Also described herein are apparatuses in which the gripping electrodes are formed by a planar electrode on the first and / or second jaws from which a tissue grip extends or is recessed, e.g., as a groove formed into or onto the electrode. The tissue grip may be surrounded by the electrode. In some examples, the tissue grip(s), e.g., groove(s), formed on a first electrode of a first jaw may engage with a second tissue grip(s), e.g., groove(s), formed on the second electrode of a second jaw. These tissue grips may engage with each other on opposite jaws in a male / male, male / female, or female / female engagement.

[0024] For example, a clamping apparatus for delivering pulsed electrical energy may include: a first jaw; a first electrode extending over the first jaw; one or more first tissue grips extending into or from a tissue-contacting surface of the first electrode so that the tissuecontacting surface of the first electrode surrounds the one or more first tissue grips; a second jaw that is opposite from the first jaw; a second electrode extending over the second jaw; one or more second tissue grips extending into or from a tissue-contacting surface of the second electrode so that the tissue-contacting surface of the second electrode surrounds the one or more second tissue grips; an actuator configured to adjust a separation between the first jaw and the second jaw; and a connector at a proximal end of the apparatus configured to form an electrical connection between the first and second electrodes and an outside source of electrical energy (e.g., a pulse generator). The one or more first tissue grips may include one or more grooves formed in the first electrode. In some examples the one or more first tissue grips may comprise one or more protrusions extending proud of the tissue-contacting surface of the first electrode. In some examples the one or more second tissue grips may be configured to mate in a female-to-male engagement with the one or more first tissue grips; the one or more second tissue grips may be configured to mate in a female-to-female engagement with the one or more first tissue grips; alternatively, the one or more second tissue grips may be configured to mate in a male-to-male engagement with the one or more first tissue grips.

[0025] The first jaw and the second jaw may extend in a curved length. In any of these apparatuses the first jaw and the second jaw may be configured to open and close substantially in parallel. The connector may be configured to connect to a pulse generator configured to deliver electrical pulses having an amplitude of at least 0.1 kV, at least 3kV, at least lOkV, etc. For example, an apparatus for delivering pulsed electrical energy, the apparatus comprising: a clamping applicator comprising: a first jaw; a first electrode extending over the first jaw; one or more first tissue grips extending into or from a tissuecontacting surface of the first electrode so that the tissue-contacting surface of the first electrode surrounds the one or more first tissue grips; a second jaw that is opposite from the first jaw; a second electrode extending over the second jaw; one or more second tissue grips extending into or from a tissue-contacting surface of the second electrode so that the tissuecontacting surface of the second electrode surrounds the one or more second tissue grips; an actuator configured to adjust a separation between the first jaw and the second jaw; and a connector at a proximal end of the apparatus configured to form an electrical connection between a pulse generator and the first and second electrodes; and the pulse generator,wherein the pulse generator is configured to provide electrical pulses (for example, microsecond or sub-microsecond electric pulses) having an amplitude of at least 0.1 kV.

[0026] Also described herein are methods of using any of these apparatuses, e.g., to treat tissue. For example, a method may include: positioning a tissue between the first and second jaws of any of the clamping applicators described herein; closing the first and second jaws to securely clamp the tissue between the first and second jaws; and applying pulsed electrical energy (e.g., comprising sub-microsecond electrical pulses) having an amplitude of at least 0.1 kV between the first electrode and the second electrode. The tissue may be any soft tissue, for example: heart, pulmonary veins or other vessels, prostate, pancreas, lung, kidney, liver tissue, etc.

[0027] The methods and apparatuses described herein may improve the control of the application of energy to the tissue. In variations in which the applicator includes one or more movable jaws, the apparatus or method may provide the applied energy from electrodes that are themselves configured to be gripping, while minimizing damage to the tissue being treated as well as adjacent tissues. In general, the apparatuses and method described herein may include one or more jaws or arms that are configured to contact, and at least partially enclose a target tissue to be treated. The one or more jaws may equivalently be referred to herein as arms. In examples having two jaws (e.g., two arms), the angle between the two jaws (or arms) may be referred to herein as the jaw angle or arm angle, particularly in reference to scissoring jaws (e.g., scissoring arms). In some cases, the jaws may be configured to operate substantially parallel, as mentioned above. Thus, the jaws (e.g., arms) may be configured to scissor open and closed to open and close in parallel, or to open and / close in some combination of scissoring and parallel opening. In some examples the applicator may include jaws that may curve, have a bend, etc. In general, each jaw may include an electrode on a tissue-facing surface of the jaws, between which tissue is to be held.

[0028] These methods and apparatuses may be configured to apply a consistent electric field. In some examples, these methods and apparatuses may be configured to control the applied energy density between electrodes on the applicator, e.g., between the electrodes on the jaws. These methods and apparatuses may control one or more of: the pulse width of the applied energy, the amplitude (e.g., voltage and / or current amplitude), the number of pulses applied, etc.

[0029] The apparatuses described herein for treating a tissue between pairs of electrodes of an applicator may include a pair of jaws (e.g., arms) holding and / or incorporating electrodes. For example, these apparatuses may be configured to treat tissue by applying electrical pulses. Any type of electrical energy may be applied, including any type of pulsedelectrical energy. In some cases, the applied energy may be microsecond or sub-microsecond pulses (e.g., nanosecond pulses) of energy. In some cases, it may be particularly beneficial to use very short (e.g., microsecond and / or sub-microsecond) pulses. However, it should be understood that these apparatuses are not limited to sub-microsecond pulsing. Thus, although the methods and apparatuses described herein may be particularly well suited for submicrosecond pulsing (e.g., nanosecond pulsing) treatments, the methods and apparatuses described herein may be used with, or adapted for use with, any pulsed electrical energy having a variety of durations and / or formats, including but not limited to millisecond pulsing, microsecond pulsing, and / or monophasic or biphasic pulsing, or other appropriate energy modalities. The method and apparatuses described herein may be used with bipolar energy delivery (e.g., applied between pairs of electrodes). These methods and apparatuses may also be adapted for use with monopolar energy delivery.

[0030] According to some embodiments of the present disclosure, the jaws may be configured to pivot relative to each other. For example, the first jaw may be configured to pivot relative to the second jaw, the second jaw may be configured to pivot relative to the first jaw, and / or the first and second jaws may be configured to pivot relative to each other.

[0031] In any of these examples, the first jaw and / or the second jaw may be moved relative to each other by operating the actuator. The actuator may include a handle and / or grip. The actuator may be configured to be held by one or more of the fingers (index finger, thumb, ring finger, etc.), palm, etc. In some examples the actuator may include a button, slider, lever, etc. The actuator may be powered (e.g., may include a motor, etc.) or unpowered. The actuator may be biased, e.g., including one or more springs, etc. In some examples the actuator may include a lock, holding the relative position of the first and second jaws. In any of these apparatuses the jaws may be controlled as part of a robotic manipulator, and they may be attached to a robotic arm.

[0032] The pulse generator may be coupled to a controller (e.g., energy controller). In any of these examples the pulse generator may comprise a microsecond or sub-microsecond, high voltage pulse generator (e.g., a nanosecond pulse generator). The energy controller may be a part of (e.g., integrated with) the pulse generator or it may be separate from the pulse generator, and coupled thereto. In general, the apparatuses described herein may include a single controller (e.g., which may include the energy controller) or multiple sub-controllers (e.g., energy controller, mapping controller, sensing controller, etc.). It should be understood that, when used herein, the term “controller” or “energy controller” shall include one or a plurality of controllers configured to perform various operations described herein. The controller(s), including the energy controller, may include one or more outputs, including oneor more outputs to a display and / or memory, etc. The apparatus may include one or more inputs, including a control (e.g., trigger, button, dial, touchscreen, etc.) for activating the application of energy, etc.

[0033] The first and second jaws may be relatively long (e.g., 1 cm or greater, 1.2 cm or greater, 1.5 cm or greater, 1.8 cm or greater, 2 cm or greater, 2.2 cm or greater, 2.5 cm or greater, 2.7 cm or greater, 3 cm or greater, 3.5 cm or greater, 4 cm or greater, 5 cm or greater, 6 cm or greater, 7 cm or greater, 8 cm or greater, 9 cm or greater, 10 cm or greater, 12 cm or greater, 15 cm or greater, 20 cm or greater, etc.). The first and second jaws may be curved and / or bent. In some examples the first and second jaws are straight. In some examples, the first and second jaws may be parallel or nearly-parallel to each other rather than positioned at an angle to each other.

[0034] The apparatuses described herein may include any appropriate number of electrodes on each jaw (e.g., the first and / or second jaws). In some cases, the first jaw may include a single electrode, and the second jaw may include a single electrode; these electrodes may be configured as a bipolar pair of electrodes, as anode / cathode, etc.). In some cases, one or both jaws may include a plurality of electrodes positioned along at least a portion of a length of the jaw(s), e.g., 2 or more electrodes, 3 or more electrodes, 4 or more electrodes, 5 or more electrodes, 6 or more electrodes, 7 or more electrodes, 8 or more electrodes, etc. Although many of the examples described herein include electrodes on both the first and second jaws that are opposite from each other, in any of these examples the apparatus may include electrode(s) on just one jaw, e.g., one or more electrodes, including two adjacent (along either the length or across the width) of the jaw.

[0035] The electrodes of the plurality of electrodes may be any appropriate size, including any appropriate length, width and / or surface area, such as, e.g., a length of between about 1 mm to 50 mm long or longer (e.g., between about 2 mm to 25 mm, between about 5 mm to about 15 mm, between about 1 mm to about 15 mm, between about 1 mm to about 5 cm, between about 1 mm to about 3 cm, etc.).

[0036] The jaws may be any appropriate length, e.g., between about 1 cm and about 20 cm, between about 2 mm and about 5 cm, between about 2 mm and about 2 cm, between about 2 mm and about 1 cm, between about 2 mm and about 8 mm, between about 2 cm and about 14 cm, between about 2 cm and about 13 cm, between about 2 cm and about 12 cm, between about 2 cm and about 11 cm, between about 2 cm and about 10 cm, etc.). The width may be about 0.5 mm to 3 cm wide (e.g., about 0.5 mm to 30 mm, 0.5 mm to 25 mm, about 0.5 mm to 20 mm, 0.5 mm to 15 mm, 0.5 mm to 12 mm, 0.5 mm to 11 mm, 0.5 mm to 10 mm, 0.5 mm to 9 mm, 0.5 mm to 9 mm, etc.). Any appropriate length and width of the jawmay be used. The electrodes may be arranged along the length of the jaw(s). The opposite jaw may include a gripping surface formed on the tissue-facing surface of the opposite jaw.

[0037] Also described herein are methods of using any of these apparatuses to apply energy to a tissue held between the jaws. For example, described herein are methods including: positioning a tissue between the first and second jaws of a clamping applicator so that the tissue is gripped by an electrically conductive gripping region on one or both jaws, wherein the electrically conductive gripping comprises a plurality of lengths of a wire electrode that is electrically coupled together and arranged adjacent to each other; holding the tissue between the first and second jaws in electrical contact while the tissue is gripped by the gripping region; and applying pulsed electrical energy between the jaws from the electrically conductive gripping region.

[0038] In some examples, the method includes applying pulsed electrical energy by applying pulsed energy having an amplitude of at least 0.1 kV. Any appropriate pulse duration may be used, including but not limited to applying sub-microsecond electrical pulses. In any of these apparatuses and methods, the apparatus may be configured to apply energy, for example, applying pulsed energy (including but not limited to sub-microsecond, e.g., nanosecond, pulses) including less than 50 ps, 1 ps or less, 990 ns or less, 950 ns or less, 900 ns or less, 800 ns or less, 700 ns or less, 600 ns or less, 500 ns or less, etc.) electrical pulses. In some of the implementations, the electrical pulse may have an amplitude of at least 0.1 kV (e.g., at least 0.5 kV, at least 1 kV, at least 1.2 kV, at least 1.5 kV, at least 2 kV, at least 5 kV, at least 7 kV, 10 kV, 15kV, 20 kV, 30 kV, 50 kV, etc.).

[0039] The electrically conductive gripping region (such as gripping surface) may comprise multiple lengths of wire that may be electrically coupled together and arranged adjacent to each other along at least a portion of a tissue-contacting surface of the jaw. In any of these examples holding the tissue between the first and second jaws may comprise holding the tissue between electrically conductive gripping regions on both jaws.

[0040] In some implementations, the multiple lengths of wire may be arranged as multiple stacked lengths of wire on either the first or second jaws, or on both jaws. These multiple stacked lengths of wire may be configured to slide over and against each other when tension or force is applied. Any of these methods may include applying a force to the multiple lengths of wire to displace one or more of the lengths of wire to enlarge a region between the first and second jaws that is in electrical contact with the tissue.

[0041] Any appropriate tissue may be treated, including one or more of: heart, pulmonary veins, pharynx, esophagus, stomach, small intestine, large intestine, liver, gallbladder, mesentery, pancreas, larynx, trachea, bronchia, lungs, diaphragm, kidney, bladder, urethra,ovaries, fallopian tubes, uterus, vagina, testes, epididymis, vas deferens, prostate, bulbourethral glands, pituitary gland, pineal gland, thyroid gland, adrenal glands, arteries, veins, lymph nodes, lymphatic vessel, spleen, thymus, skin, eyelids, lips, tongue, ear, nose, vocal cords.

[0042] Also described herein are methods of forming any of these applicators. For example a method of forming an applicator having an electrically conductive grip may include: fabricating a first jaw and a second jaw; forming a first electrically conductive grip region by bending or shaping one or more wires to form a first plurality of lengths of wire that are arranged adjacent to each other; coupling the first electrically conductive grip region to the first jaw; coupling a second electrically conductive grip region comprising a second plurality of lengths of wire that are arranged adjacent to each other to the second jaw; and coupling the first and second jaws to each other or to a body of the applicator so that at least one of the first and second jaws may move relative to each other. The first and second jaws may be coupled to each other or to the applicator prior to coupling the first electrically conductive grip region to the first jaw.

[0043] Any of these methods may include coupling the first electrically conductive grip region to a first electrode on the first jaw. The first electrode may be coupled to the first jaw prior to coupling to the first electrically conductive grip region. Alternatively, the first electrode may be coupled to the first jaw after coupling to the first electrically conductive grip region.

[0044] Forming the first electrically conductive grip region may comprise bending or shaping the one or more wires to form the first plurality of lengths of wire so that the first plurality of lengths of wires is arranged adjacent to each other to form a tissue contacting surface comprising curved sides of the first plurality of lengths of wires.

[0045] Any of these methods may include positioning the tissue or having the tissue positioned between the jaws. In some examples the tissue may be a cardiac tissue, and the method may include having the tissue positioned between the first and second jaws. In any of these methods positioning the tissue may include closing the first and second jaws against the tissue, for example, in a scissoring manner or in a parallel manner. According to another aspect of the present disclosure, any of the methods may be applied to treatment of atrial fibrillation or other cardiac arrhythmias. Accordingly, in some examples a method of treating atrial fibrillation is provided.

[0046] All of the methods and apparatuses described herein, in any combination, are herein contemplated and can be used to achieve the benefits as described herein.BRIEF DESCRIPTION OF THE DRAWINGS

[0047] A better understanding of the features and advantages of the methods and apparatuses described herein will be obtained by reference to the following detailed description that sets forth illustrative embodiments, and the accompanying drawings of which:

[0048] FIG. l is a schematic example of a system for treating patients using the method as described herein.

[0049] FIG. 2A schematically illustrates one example of an apparatus for delivering high field strength electric pulses (e.g., microsecond or sub-microsecond pulses), in which the apparatus includes a pair of jaws with gripping electrodes positioned therebetween.

[0050] FIGS. 2B-2C each shows an example of a pair of jaws similar to those in FIG. 2A. FIG. 2B shows the jaws in an open configuration with a tissue between the first and second jaws. FIG. 2C shows the jaws in a closed position, with the jaws closed onto the tissue.

[0051] FIG. 3 A schematically illustrates one example of an apparatus for delivering high field strength electric pulses (e.g., microsecond or sub-microsecond pulses), in which the apparatus includes parallel-opening jaws with gripping electrodes positioned therebetween.

[0052] FIGS. 3B-3C each shows an example of the operation of the jaws of FIG. 3A. FIG. 3B shows the jaws in an open configuration with a tissue between the first and second jaws. FIG. 3C shows the jaws in a closed position, with the jaws closed onto the tissue.

[0053] FIG. 4 A shows an example of a jaw of an applicator apparatus having a plurality of tissue grips formed as channels into the electrode.

[0054] FIG. 4B shows an example of a section through a jaw having a male-female configuration of the grips.

[0055] FIG. 5 shows an example of a jaw of an applicator apparatus having a single long tissue grip formed as a channel into the electrode.

[0056] FIG. 6 A shows an example of a jaw of an applicator having a mesh electrode forming a gripping region.

[0057] FIGS. 6B-6D illustrate examples of mesh configurations that may be used.

[0058] FIG. 7 shows an example of a jaw of an applicator including a wire electrode configured as a gripping electrode.

[0059] FIG. 8A shows another example of a wire electrode configuration as a gripping electrode.

[0060] FIG. 8B shows yet another example of a wire electrode configuration as a gripping electrode.

[0061] FIGS. 9A-9B illustrate an example of a jaw of an applicator including a plurality of multiple stacked wire electrodes forming a gripping region that is configured to be compressed and decompressed.

[0062] FIG. 10 schematically illustrates an example of a method of making an applicator as described herein.

[0063] FIG. 11 schematically illustrates one example of a method of using an applicator as described herein.DETAILED DESCRIPTION

[0064] An apparatus (e.g., system, device, etc., including software, hardware and / or firmware, and in some cases an applicator) for treating tissue by the application of a pulsed electrical energy, including using microsecond and sub-microsecond pulses, may secure tissue between two jaws that each includes one or more electrodes, in which the tissue may be more reliably held by tissue gripping surfaces (“grips”) formed on each of the electrodes. It may be particularly beneficial to form the gripping surfaces in or on the surface of the electrodes (including electrode itself acting as a gripping surface as described in more detail below).

[0065] In general, described herein are clamping apparatuses for delivering pulsed electrical energy, and in particular relatively high electric field energy, that include at least one jaw having an electrode on a surface of the jaw in which the electrode(s) forms a first tissue-gripping surface. The apparatus may be referred to herein as an applicator and may generally include a pair of jaws that articulate to open and close so that they may grip a tissue to be treated therebetween. A first jaw may be positioned opposite a second jaw, so that each of the first jaw and the second jaw has a tissue-facing side that also face each other as the jaws are closed. The electrode forming the tissue-gripping surface may be arranged on and across, e.g., atop, embedded into, etc.) the tissue-facing surface of the jaw(s). Both the first and second jaws may include electrode(s) with tissue-gripping surfaces. The tissue-gripping surfaces may be complimentary, e.g., may engage with each other. The apparatus (e.g., applicator) may also include an actuator that is connected to either the first and / or the second jaw to adjust the separation between the first jaw and the second jaw, e.g., to open and / or close the jaws. The apparatus may also include a connector (e.g., an electrical and / or mechanical connector) at a proximal end of the clamping apparatus configured to form an electrical connection between a pulse generator and the first and second electrodes. The connector may include a cable, plug, etc.

[0066] Any of these apparatuses may also include a pulse generator that is connected, or configured to connect, to the applicator. The pulse generator may be, for example, a microsecond or a sub-microsecond pulse generator, configured to generate a plurality of electrical pulses, such as those having an amplitude of at least 0.1 kV or higher. In case of the sub-microsecond pulse generator, a pulse duration may include single digit microseconds, for example, 10 microseconds or less. In case of the microsecond pulse generator, a pulse duration may include single digit milliseconds, for example 10 milliseconds or less. Because these may be configured specifically for use with high electric field pulsed energy, the shape of the tissue-facing side of the electrode(s), including the gripping surfaces, may be also configured to reduce or eliminate arcing, including using radiused edges (e.g., edges having a radius of curvature of between 0.01 mm and 2 mm).

[0067] Thus, the apparatuses and methods described herein may include one or more jaws, which may equivalently be referred to as arms, that are configured to grasp tissue so that energy may be applied from electrodes on the jaws. The methods and apparatuses described herein may provide a predictable treatment of tissues having different thicknesses and / or compositions by more reliably securing the tissue to the jaws directly through the electrodes delivering the therapeutic energy. This may be achieved in any of the methods and apparatuses described herein by using the electrodes having the tissue-gripping surfaces arranged along the jaw(s) of the applicator between which tissue may be positioned. In some examples the jaws may be scissoring and may diverge at an angle relative to each other about a pivot or fulcrum point or region. The jaws may be opened or closed to a greater or lesser degree, which may increase or decrease the separation between the electrodes. In some examples, the jaws may open in a parallel (or substantially parallel) manner. The tissue held between the jaws may also have a different, e.g., varying, thickness. In examples in which the jaws pivot about a fulcrum (e.g., like scissors) the spacing between the electrodes on opposite jaws may increase or decrease.

[0068] As will be described in greater detail below, the grips (e.g., gripping surfaces) of the electrodes may be formed from the electrodes, and may be formed as one or more protrusions into and / or out of a relatively flat surface of the electrode, e.g., as one or more grooves or elevations, or as a conductive mesh electrode having a plurality of lengths that form a grid-like gripping pattern, and / or as one or more elongate lengths of wire extending along the jaw(s)(e.g., along axis of the jaw(s)). In some examples, the gripping surfaces may be formed only at the distal portion of the length of the electrodes, in other examples the gripping surfaces may be formed along the full length or some portion of the length of the electrodes. The multiple lengths of wire forming an electrode, and in particular the multiplelengths of wire forming the grip region may be formed of a single wire or multiple wires. For example, a single wire may form multiple lengths of wire extending along and / or on the gripping surface.

[0069] The apparatuses described herein may therefore include an applicator (e.g., having a pair of jaws) including or configured for use with a pulse generator for applying pulses, such as sub-microsecond pulses. The apparatus may include a controller (also referred to in some examples herein as an energy controller) that may be integrated with the applicator and / or with the pulse generator; in some examples the controller is separate from, but connected to, or configured to connect to, applicator and / or pulse generator.

[0070] The pulse generator may be configured to generate a plurality of electrical pulses, such as those having an amplitude of at least 0.1 kV and a duration in microsecond and submicrosecond range, for example, less than 100 microseconds, less than 10 microseconds, less than 1000 nanoseconds, etc. The system may include a connector, e.g., a high voltage connector adapted to couple the elongate applicator tool to the pulse generator. The pulse generator may include a port configured to connect to the high voltage connector.

[0071] FIG. 1 illustrates one example of a system 100 (also referred to herein as a high voltage system) for delivering high voltage, fast (e.g., 10 microsecond or less) pulses of electrical energy that may include an applicator 102 configured as described herein. The systems described herein may include any of the applicators shown and described herein. In FIG. 1, the applicator example shown has a pair of jaws, a pulse generator 107, footswitch 103, and user interface 104. The controller (e.g., energy controller) may be part of the pulse generator 107 and / or part of the applicator 102 or separate from them. The system 100 may provide the high voltage electrical energy pules to treat tissues, including tissues of one or more organs (e.g., heart, pulmonary veins, pharynx, esophagus, stomach, small intestine, large intestine, liver, gallbladder, mesentery, pancreas, larynx, trachea, bronchia, lungs, diaphragm, kidney, bladder, urethra, ovaries, fallopian tubes, uterus, vagina, testes, epididymis, vas deferens, prostate, bulbourethral glands, pituitary gland, pineal gland, thyroid gland, adrenal glands, arteries, veins, lymph nodes, lymphatic vessel, spleen, thymus, skin, eyelids, lips, tongue, ear, nose, vocal cords, etc.). In some examples the apparatuses and methods described herein may be used to treat one or more of these tissues, in some examples as part of a minimally invasive therapy. The methods and apparatuses described herein may be used to treat circulatory system tissue (e.g., heart, artery, vein, etc.). As stated above, in some examples the methods and apparatuses described herein may be used to treat a tumor or tumors, including cancerous, pre-cancerous, benign or non-malignant tumors, lesions or growths. In some other examples, the methods and apparatuses described herein may be usedto treat any feasible tissue or cell. Non-limiting examples of pulse generators that may be used with any of the apparatuses (e.g., systems) described herein may include, but are not limited to, those shown in U.S. Patent No. 11,696,800 (“High-Voltage Analog Circuit Pulser”), U.S. Patent No. 11,452,870 (“Nanosecond pulsed power sources having multi -core transformers”), and U.S. Patent No. 11,723,712 (“High-Voltage Analog Circuit Pulser and Pulse Generator Discharge Circuit”), each of which is herein incorporated by reference in its entirety.

[0072] In some examples the apparatus includes one or more inputs, such as a footswitch 103, shown in FIG. 1 as connected to housing 105, which may enclose the electronic components, including controller and / or sub-controllers, including but not limited to the energy controller. The footswitch in FIG. 1 is connected to the controller through a cable and connector 106. The elongate applicator tool 102 may include a pair of jaws (not shown) which may include electrodes and is connected to housing 105 and the electronic components therein through a cable 137 and high voltage connector 112. The high voltage system 100 may also include a handle 110 and storage drawer 108. The system 100 may also include a holder (e.g., holster, carrier, etc.) (not shown) which may be configured to hold the elongate applicator tool 102.

[0073] A human operator may select a number of pulses, amplitude (e.g., voltage amplitude and / or current amplitude), pulse duration, and frequency information for a target treatment, for example by inputting such parameters into a numeric keypad or a touch screen of interface 104. The apparatus may control the energy applied thought the jaws. In some examples, the pulse width can be varied. A controller may send signals to pulse control elements within system 100. In some examples, fiber optic cables are used which allow control signaling while also electrically isolating the contents of the metal cabinet with submicrosecond pulse generation system 100, e.g., the high voltage circuit, from the outside. In some examples the system 100 may be battery powered and / or may be powered from a wall outlet. In some examples, the system may be configured for monopolar treatment and may include, for example, a ground electrode 133 (e.g., a return electrode pad).

[0074] The applicator tool 102 may be hand-held (e.g., by a user) or it can be affixed to a movable arm of a robotic system, and its operation may be at least partially automated or fully automated, including computer-controlled.

[0075] FIG. 2A schematically illustrates an example of an apparatus 200, including an example of an applicator 201 connected (via connector 219) to an energy controller 213 which may be part of or may be coupled to a pulse generator 217. The apparatus shown in FIG. 2A is configured for delivering electrical pulses to a tissue held between the jaws 203,205. In this example, the applicator includes a first jaw 203 having a proximal end and a distal end and a second jaw 205 having a proximal end and a distal end. The second jaw 205 is hinged relative to the first jaw 203, and both the first 203 and second 205 jaws extend distally from an elongate body 209. Alternatively, the first jaw may be movable relative to the second jaw, or the first and second jaws may both be configured to move relative to each other and / or relative to the elongate body. The elongate body 209 may be rigid or flexible (e.g., bendable) and may be straight or curved. The jaws may be opened or closed by actuating an actuator 211, shown in this example on a proximal end region of the elongate body 209. The actuator may include any appropriate control. In this example the actuator 211 (jaw actuator) is a lever or trigger that may be operated by a user’s hand (e.g., fingers) while holding the elongate body 209. Any other actuator, such as mechanical, electromechanical, or computer-controller, is within the scope of the present disclosure. At least one jaw (e.g., first jaw 203 and / or second jaw 205) may include an electrode 202 extending down the length of the jaw having one or more tissue gripping surfaces formed on or as a part of the electrode. FIG. 2A is not shown to scale. For example, the elongate body may be longer or shorter (straight or curved), the jaws may be longer or shorter (straight or curved), and the electrode(s) may be larger or smaller. In some examples one or a plurality of electrodes may be included.

[0076] In general, the connector 219 may be part of the applicator (e.g., one end of the elongate body of the applicator) or may be separate, and may couple to the applicator so that the electrode(s) may be separately or collectively (or sub-sets of the electrodes) addressed or addressable by the controller (energy controller 213). In some cases, the connector may include a plug, clip, insert, adapter, etc. for coupling to the controller. As described herein, in some cases the applicator may be integrated with the controller, thus the connector may be optional and / or fully internal.

[0077] In the example shown in FIG. 2A the electrode 202 is positioned along a length of the first jaw 203 and forms a gripping surface (not visible in this example), as will be described below in reference to FIGS. 4-7. A tissue may be securely held between the jaws by the gripping surface(s) of the electrode(s). Although this example shows a scissoring jaw, in some cases the jaws may operate in parallel (e.g., so that the first and second jaws close while remaining substantially parallel). The jaws may be opened / closed to hold tissue by operating the actuator 211. For example, FIGS. 2B and 2C illustrate the jaws of FIG. 2 A in an open (FIG. 2B) and partially closed (FIG. 2C) configuration, shown clamping onto a tissue 221.

[0078] In FIG. 2B the first jaw 203 and second jaw 205 may both include an electrode along the length of the jaw having a gripping surface formed thereon (or just one of the jaws may include one or more electrodes). In FIG. 2B the tissue 221 is positioned between the jaws, but the jaws are opened. In any of these apparatuses the jaws may be biased open, biased closed, or maintained in a neutral position unless actuated open or closed. In FIG. 2C the jaws are closed by actuating the actuator, closing the jaws onto the tissue 221. The jaws may be closed onto the tissue to compress the tissue, however the force applied to compress the tissue may be limited to prevent damage to the target tissue or surrounding tissue. Thus, in any of these examples the amount of force applied, e.g., by the actuator 211, may be limited, in order to prevent or limit damage to the tissue. For example, the apparatus may include a force sensor (not shown) configured to detect the clamping force of the jaws. Even with limited force applied, slipping of the tissue may be prevented by including the gripping surfaces as part of the electrodes. In FIG. 2C, with the jaws shut onto the tissue, the tissue is held securely between the jaws preventing pull-out or displacement of the tissue and ensuring maintained contact with the electrodes and the target tissue between the jaws. Although not visible in FIGS. 2B-2C, in some cases the second jaw 205 may also include one or more electrodes having gripping surface which may contact the tissue when the jaws are closed against the tissue.

[0079] FIGS. 3A-3C schematically illustrate another example of an apparatus 300, including one example of an applicator 301 connected (via connector 319) to an energy controller 213 which may be part of or may be coupled to a pulse generator 217. The apparatus shown in FIG. 3 A is similar to that shown in FIGS. 2A-2C, but includes a parallel- opening / closing jaws. As in FIGS. 2A-2C, the apparatus shown in FIG. 3 A is configured for delivering electrical pulses to a tissue held between the jaws 303, 305. The first jaw 303 has a proximal end and a distal end and the second jaw 305 has a proximal end and a distal end. In this example, the second jaw 305 is bent with the same angle as the first jaw 303, and both the first 303 and second 305 jaws extend distally from an elongate body 309. The first jaw 303 is axially movable relative to the second jaw (alternatively the first and second jaws may both be configured to move relative to each other and / or relative to the elongate body). The elongate body 309 may be rigid or flexible (e.g., bendable) and may be straight or curved. The jaws may be opened or closed by actuating an actuator 311, shown in this example at a proximal end region of the applicator 301. At least one jaw (e.g., first jaw 303 and / or second jaw 305) may include an electrode 302 extending down the length (e.g., a full length or a part of the length) of the jaw having one or more tissue gripping surfaces formed on the electrode or electrode itself act as a gripping surface. FIGS. 3A-3C are not shown to scale. Forexample, the elongate body may be longer or shorter (straight or curved), the jaws may be longer or shorter (straight or curved), and the electrode(s) may be larger or smaller. In some examples more or fewer electrodes may be included.

[0080] As mentioned in reference to FIGS. 2A-2C, the connector 319 may be part of the applicator (e.g., one end of the elongate body of the applicator) or may be separate, and may couple to the applicator so that the electrode(s) may be separately or collectively (or sub-sets of the electrodes) addressed or addressable by the controller (energy controller 213).

[0081] In FIG. 3A the electrode 302 is positioned along a length of the first jaw 303 and forms a gripping surface (not visible in this example), as will be described below in reference to FIGS. 4-7. A tissue may be securely held between the jaws by the gripping surface(s) of the electrode(s). The jaws may be opened / closed to hold tissue by operating the actuator 311, as shown in FIGS. 3B and 3C. For example, the jaws of FIG. 3B are shown open, but may move 316 axially to open more or to close, as shown in FIG. 3C, to clamp onto a tissue 321.

[0082] In FIG. 3B the first jaw 303 and second jaw 305 may both include one or more electrodes along the length of the jaw having a gripping surface formed thereon (or just one of the jaws may include one or more electrodes). In FIG. 3B the jaws are positioned around the tissue 321, but the jaws are opened. As mentioned, the jaws may be biased open, biased closed, or maintained in a neutral position unless actuated open or closed. In FIG. 3C the jaws are closed by actuating 316’ the actuator to close the jaws onto the tissue 321. As mentioned, the jaws may be closed onto the tissue to compress the tissue, however the force applied to compress the tissue may be limited to prevent damage to the target tissue or surrounding tissue. Thus, the amount of force applied, e.g., by the actuator 311, may be limited, in order to prevent or limit damage to the tissue. For example, the apparatus may include a force sensor (not shown) configured to detect the clamping force of the jaws. Even with limited force applied, slipping of the tissue may be prevented by including the gripping surfaces as part of the electrodes. In FIG. 3C, with the jaws shut onto the tissue, the tissue is held securely between the jaws preventing pull-out or displacement of the tissue and ensuring maintained contact with the electrodes and the target tissue between the jaws.

[0083] The gripping surface formed on the electrode(s) for the apparatuses and methods described herein may be configured as one or more tissue grips extending into or from a tissue-contacting surface of the electrode(s). In some cases, the tissue grips may be formed as one or more projections and / or recesses extending from or into the tissue-contacting surface of the electrode. The tissue-contacting surface of the electrode may surround the tissue grips.

[0084] FIG. 4 A shows an example of a jaw 405 having a tissue-facing surface on which the electrode 402 is mounted. The electrode in this example is a generally flat, e.g., plateelectrode, in which a plurality of tissue grips 406 are formed by forming discrete grooves into the tissue contacting surface 407 of the electrode. In some examples the tissue grip(s) may instead extend proud of the generally flat surface of the electrode forming a bump. The tissue grip(s) may be electrically conductive and may be formed of the same material as the electrode (e.g., metal, conductive polymer, etc.) As mentioned before, the tissue grips 406 may be present along the full length of the electrodes, partial length, a distal portion, etc.

[0085] The tissue grip(s) may be sized to engage with the tissue while minimizing arcing. For example, the tissue grip(s) may have rounded (e.g., radiused) edges, as shown in FIG. 4A. The radius of curvature may be 0.01 mm or greater (e.g., 0.05 mm or greater, 0.1 mm or greater, 0.2 mm or greater, 0.3 mm or greater, 0.4 mm or greater, 0.5 mm or greater, 0.7 mm or greater, 0.8 mm or greater, etc.). Likewise, the corners and edge of any other portion of the electrode may have a radiused edge (e.g., be curved or rounded). The radius of curvature does not need to be constant.

[0086] In some examples, the tissue grip(s) may be configured as an elongate groove, as shown in FIG. 5. In this example the electrode 502 is mounted to the jaw 505 as in FIG. 4A, but the tissue grip 506 is formed as an elongate groove extending along the surface of the electrode. The edges of the groove may be also radiused as described above. Alternatively, in some cases the tissue grip(s) may project from the tissue-contacting surface of the electrode.

[0087] In any of these apparatuses the tissue grip(s) on one jaw may be configured to engage with tissue grip(s) on the opposite jaw. For example, the tissue grips on opposite jaws may engage with each other as male-female engagement, in which, for example, as shown in the sectional view of FIG. 4B, the tissue grip(s) 406’ may extend from the electrode surface on one jaw and the complementary tissue grips 406 are recessed into the electrode surface on the opposite jaw; with the jaws closed, the tissue grips on opposite jaws may mate with each other. In any of these examples, the tissue grips may be configured to provide a space for the tissue (to prevent pinching or crushing of the tissue, particularly at the edges. For example, as shown in FIG. 4B, the male region may have a smaller height and / or width, wm, as compared to the height and / or width, wf, of the female grip region. The spacing (e.g., the difference between wmand Wf,) may be constant or variable. In some cases the spacing may decrease with distance from the edge of the jaw. The distance (e.g., wmor wf) may be between about 0.1 mm and about 10 mm (e.g., between about 0.5 mm and 10 mm, 0.5 mm and 7.5 mm 0.5 mm and 5 mm, 1 mm and 10 mm, 1 mm and 7 mm, 1 mm and 5 mm, etc.).

[0088] The tissue grips may be positioned on a portion of the tissue-contacting region of the jaw, or on the entire tissue-contacting region. In some cases, the tissue grips may be positioned only at the distal end region of the tissue contacting portion of the jaw; theremaining tissue-contacting portion may include an electrode that does not include the grip. For example, FIGS. 4A and 5 show examples of jaws including a tissue grip region that forms the entire tissue-contacting surface of the electrode, e.g., along a whole length of the electrodes. Alternatively in some cases one or both jaws may include a tissue grip region over just a portion (e.g., the distal and / or middle and / or proximal region) of the tissue contacting region of the jaws. In some cases, the tissue grip may extend laterally over just one side or portion of jaws (e.g., a left side or right side).

[0089] Alternatively, in some cases the tissue grips on opposite jaws may engage with each other in a male-male engagement, in which the tissue grip(s) extend from the electrode surface on one jaw and the complementary tissue grips both extend from the electrode surface at complementary locations. In some cases, the tissue grips may extend from locations on opposite jaws that are offset from the tissue grips on the opposite jaw. Alternatively, in some cases the tissue grips on opposite jaws may engage with each other in a female-female engagement, in which the tissue grip(s) extend from the electrode surface on one jaw and the complementary tissue grips are both recessed into the electrode surface at complementary and / or offset locations.

[0090] In general, any of the apparatuses described herein may include a tissue grip (e.g., tissue gripping surface) on just one of the jaws, rather than on both jaws. For example, in some cases the tissue grips may be present on just one jaw (e.g., one side of the pair of jaws), and the tissue grip may engage with the tissue; the opposite side of the tissue may engage with an electrode surface that is not necessary tissue gripping.

[0091] Any of the apparatuses described herein may include tissue grips (e.g., tissue gripping surfaces) that are formed of a mesh material (e.g., a wire mesh). In some cases, the mesh may be a wire mesh that is electrically conductive. The mesh may be applied onto / over a flat electrode surface (e.g., a plate electrode) and / or the electrode may be formed of just the mesh. In general, the mesh may be formed of a single conductive body, or of a plurality of strands of conductive material that are woven, braided, or otherwise formed into the mesh. The mesh may be any appropriate shape, including triangular, rectangular, square, diamondshaped, hexagonal, heptagonal, octagonal, etc. The mesh may be formed as a plate or sheet of material having openings therethrough. The mesh may generally be a conductive material that has rounded or radiused edges, as described above. The mesh forming the electrode and forming the gripping surface of the electrode may be any appropriate material, including metallic, e.g., alloys including nickel -titanium alloys, siler, gold, platinum, etc. and / or polymeric materials. The mesh may extend in a generally flat surface and may be supported against the tissue-facing side of the jaw.

[0092] For example, FIG. 6A illustrates one example of a jaw 603 having an electrode 602 including a mesh 606. In this example, the mesh is a rectangular mesh that is woven with strands forming the mesh crossing over each other. FIGS. 6B-6D illustrate examples of meshes that may be used. FIG. 6B shows a square mesh lattice formed of strands that are separated by a minimum distance, d, to form openings therethrough. FIG. 6C shows an example of a mesh having a diamond-shaped lattice pattern with a minim separation distance, d’. In both FIGS. 6B and 6C the mesh is shown in a single plane; in some cases, the mesh may be formed of strand lengths that extend out of / into the plane, as shown in FIG. 6D. In FIG. 6D the mesh lattice is formed by crimped strands that are woven over / under each other, having a minimum separation distance of d”.

[0093] Any appropriate lattice size may be used for the mesh. For example, the mesh may have a gap size of less than 1 cm between adjacent strands of the mesh (e.g., between 0.1 mm and 1 cm, between about 0.1 mm and 9 mm, between about 0.1 mm and 8 mm, between about 0.5 mm and 7 mm, between about 0.5 mm and 6 mm, between about 0.5 mm and 5 mm, between about 0.5 mm and 4 mm, between about 0.5 mm and 3 mm, 9 mm or less, 8 mm or less, 7 mm or less, 6 mm or less, 5 mm or less, 4 mm or less, 3 mm or less, 2 mm or less, etc.).

[0094] In FIG. 6A the jaw shown in curved. Any appropriate jaw length and shape (curved, straight, etc.) may be used. In general, the jaws may be part of an applicator (e.g., clamping apparatus). For example a clamping apparatus for delivering pulsed electrical energy may include a first jaw, a first electrode comprising a first conductive mesh on a tissue-contacting surface of the first jaw, wherein the first conductive mesh is configured to form a first tissue-gripping surface, a second jaw that is opposite from the first jaw, a second electrode on a tissue-contacting surface of the second jaw, an actuator configured to adjust a separation between the first jaw and the second jaw and a connector at a proximal end of the clamping apparatus configured to form an electrical connection between a pulse generator and the first and second electrodes.

[0095] In some cases, the tissue grip(s) may be configured as elongate wires. For example, the electrode(s) on the jaw(s) may include an elongate length of wire that extends over and / or along the length of all or a portion of the jaw. The wire forming the tissue grip may be supported directly by the tissue-facing surface of the jaw (which may be electrically non-conductive) or it may be coupled to a flat electrode, e.g., plate electrode, on top of the tissue-facing surface of the jaw. In some cases, it may be particularly beneficial to form the electrode from one or more un-insulated length of wires that extend over the length (or aportion of the length, e.g., at least 30%, at least 40%, at least 50%, at least 60%, at least 70%, etc. of the length of the jaw).

[0096] FIG. 7 illustrates one example of a jaw 703 including an electrode forming a tissue-gripping surface from a length of wire 706 that extends back-and-forth along the curved length of the tissue-facing surface 708 of the jaw. In this example the wire 706 extends along the majority of the length of the jaw three times, in three adjacent (curving) lines. The same wire connecting the electrode (the un-insulated length of the wire 706 on the jaws) to the connector (not shown) for connection to the pulse generator may be used, but may be insulated within the rest of the jaw. The gripping pattern formed by the lengths of wire in FIG. 7 shows a curving elongate pattern of multiple turns (e.g., rows) of lengths of wire. Alternatively or additionally, in some cases the length of wire may be formed in a pattern that transverse the width as it extends along the length, making multiple turns of the wire.

[0097] The wire electrode forming the grip may be arranged in any direction. In FIG. 7 the grip region forming the electrode is a single wire that extends along the longitudinal length of the jaw. As shown, the jaw curves in an arc, and the wire lengths extend in this arc. In some cases, the length of wire extends transverse to the long axis of the jaw. For example, in FIG. 8Athe wire 806 forming the grip region extends in lengths along the short axis of the jaw 803. Thus, the tissue-facing side 808 includes the wire length that winds back and forth, in a sigmoidal or serpentine pattern. In some cases, the wire may extend in a single plane, the outer surface of which forms the tissue-contacting surface and tissue grip. In some examples the wire may extend out of plane, e.g., into the jaw body, as shown in FIG. 8B. In this example, the wire 806’ forming the tissue grip may wrap around in a coil (e.g., a helical coil), one or more sides of which may be flat or flattened to form a tissue-contacting side 808’ of the jaw 803’. The pitch of the coil may be varied based on the thickness of the wire, or to alter the gripping properties.

[0098] Any number of wires may be used to form the tissue-gripping surface. In FIGS. 7, 8A and 8B a single wire is shown, however multiple different wires, which may be electrically connected, may be used. The portion of the wire(s) that are not part of the tissuegripping surface may be insulated or un-insulated. In some examples, different regions of the jaw may be coupled to different tissue-gripping regions formed of a wire; the different gripping regions may be electrically coupled together, as mentioned above, or they may be separate (e.g., electrically separate) and may form distinct electrical regions.

[0099] In the example of FIG. 7 the un-insulated region of the wire forming the grip region is shown bent twice to create 3 adjacent rows of wire electrodes on each jaw. In someexamples the wire has more bends (e.g., three bends, four bends, five bends, six bends, etc.) to form multiple different rows, which may be adjacent to each other. For example, in one case, four longitudinal rows may be formed on each jaw. The curved surface of the wire (which may extend proud of the surface of the jaws) may create a bump. This bump-out region may form a male region, which (as described above) may be paired with and / or may engage, female region on the opposite jaw. In some examples, the gap between adjacent rows of wire(s) may form a “female” region. Thus, the wire lengths forming the grip of the first jaw may be positioned offset from and complimentary to the wire lengths forming the second jaw, forming a male-female engagement. Alternatively or additionally, in some cases the wire patterns may be aligned, to form a male-male or female-female engagement. For example, the bent wire on each jaw can be positioned such that the wires create female-female arrangement when clamped together, or male-female (e.g., with 4 rows on each jaw, the wires on one jaw may be between the wires on the opposite jaw). In some cases, the grooves created by the bent wire may mate the bump created by the bent wire on an opposite jaw, or the grooves may be against the grooves while the bumps may be against the bumps.

[0100] As mentioned, the electrodes may be formed by exposed long lengths of wire, e.g., wire lengths that are at least twice (2x) as long (e.g., 3x or greater, 4x or greater, 5x or greater, 6x or greater, 7x or greater, lOx or greater, 20x or greater, etc.) as their width. Any appropriate wire may be used, particularly wires having a diameter that is between about 0.25 mm and about 3 mm (e.g., between 0.25 mm and 2.5 mm, between about 0.25 mm and 2 mm, between about 0.25 mm and 1.5 mm, etc.). The wire may be any electrically conductive material, including nickel titanium, gold, silver, platinum, stainless steel, etc. The wire may have a radiused (e.g., rounded) cross-section; for example, the radius of the wire may be greater than about 0.125 mm in some examples.

[0101] As mentioned above, the active region of the electrode(s) may include the grip region that is formed of multiple lengths of wire, typically (but not necessarily) adjacent to each. For example, the wire lengths may be formed of uninsulated wire that is arranged along or around the jaw to form the tissue contacting surface. Any appropriate wire may be used. The wire may be nonoxidizing. The wire may be one or more electrically conductive materials, including metals (e.g., alloys, such as alloys of platinum, silver, nickel, chromium, nickel titanium, gold, etc.) or polymeric materials (e.g., conductive polymers). Electrodes may generally be formed of electrically conductive biocompatible materials.

[0102] Any size wire may be used. For example, the wire may have a diameter of about0.05 mm or more (e.g., 0.1 mm or more, 0.2 mm or more, 0.3 mm or more, 0.4 mm or more, 0.5 mm or more, 0.6 mm or more, 0.7 mm or more, 0.8 mm or more, 0.9 mm or more, 1 mmor more, 1.2 mm or more, 1.4 mm or more, 1.5 mm or more, 1.6 mm or more, 1.8 mm or more, 2 mm or more, 2.5 mm or more, 3 mm or more, etc.) or between about 0.05 mm and about 5 mm (e.g., between 0.01 and 4 mm, between about 0.1 mm and 3 mm, between 0.1 mm and 2 mm, etc.). In general, the wires may have a round / circular, oval, rectangular, pentagonal, hexagonal, etc., cross section. In examples in which multiple wires are used to form the tissue grip region different wires may be used, including different materials, different gauges, different cross-sectional diameters, etc.

[0103] Apparatuses having tissue grip(s) on the jaws formed of the electrodes in which the tissue grip (e.g., gripping region) is formed of lengths of wire or wires may be particularly advantageous, and may provide numerous benefits, including low cost and ease of fabrication (as described in greater detail in reference to FIG. 10, below. These apparatuses may also provide superior gripping and electrical contact.

[0104] In some cases, the electrode (e.g., an electrode having grip region) may include multiple adjacent lengths of the wire that may be stacked or movably held on or against the jaw. For example, in some cases the grip may be formed by multiple lengths of wire that may be configured so that the grip region changes in shape or size as the jaws are closed (and / or opened) over the tissue. In some cases, multiple stacked lengths of wire may be converted into a single layer of wires based on the pressure applied by the clamping jaws against the tissue and / or each other. The wire lengths may be supported, but somewhat movable, against the tissue-facing surface of the jaw and / or a plate electrode underlying the wire lengths.

[0105] FIGS. 9A-9B illustrate an example of an apparatus including a pair of jaws in which the size of the electrode contact on the tissue may be adjusted. In some examples, the size may be adjusted based on the applied pressure between the jaws. In some examples, the size may be adjusted by operating a control (e.g., in the handle of the treatment applicator) that adjusts the tension on the lengths of wire forming the electrically conductive grip region. In this example, when force between the jaws is above a threshold (Ft), the electrode grip surface, which is formed by a plurality of lengths of wire, may expand from a narrower configuration to a wider configuration. FIG. 9A shows an example of a section through a set of jaws including an adjustable-size grip. The apparatus includes a first jaw 903 and a second jaw 905 with a grip region 906 formed by a plurality of lengths of wire. In a first configuration, shown in FIG. 9A, multiple lengths of wire are arranged (e.g., stacked) so that they may slide over and against each other when tension or force is applied. In this first configuration the size of the contact region, Li, is relatively compact. The wire(s) forming the gripping region 906 may be pre-set into the first, compact, configuration shown in FIG. 9A. Thus, the compact configuration may be a default configuration for the apparatus. Theapparatus may be converted from the compact configuration shown in FIG. 9A to an expanded configuration shown in FIG. 9B. In FIG 9B the same apparatus has been converted to a second, larger contact region configuration of the grip region 906’ by applying force, e.g., tension either against the tissue-contacting surface or directly to the wire forming the grip, as mentioned above. In FIG. 9B the contact region has a length, L2, that is, for example, more than twice the length of the first configuration, Li. The device may include one or more (or continuous) intermediate configurations having different, e.g., progressively larger, contact surfaces.

[0106] In some examples, the force applied to transition the grip region from a narrower contact region (e.g., FIG. 9A) to a larger contact region (FIG. 9B) may be applied by compressing the jaws against each other, and / or against any material (such as tissue 921) between the jaw. When the force applied exceeds a threshold force, the lengths of wire forming the grip (e.g., contact region) may shift into a larger, expanded, configuration. Alternatively or additionally, in some examples the force applied to transition the lengths of wire between a narrower and a larger configuration may be applied by increasing and / or decreasing tension, e.g., by pulling on one or more end(s) of the wires forming the grip. In any of these cases, the threshold force may be adjusted by shape setting the wire(s) forming the lengths of wire. In some cases, the threshold force may be adjusted by adjusting the tension on the lengths of wire.

[0107] The example apparatus shown in FIGS. 9A-9B may be particularly beneficial in cases where it would be beneficial to adjust the width of an ablation site to be formed. This may allow a larger ablation area without using a different treatment applicator with a different size of the electrodes.

[0108] The jaws shown in FIGS. 7, 8A-8B, and 9A-9B may be part of an applicator (e.g., an apparatus) that is configured to clamp onto tissue using a second jaw, that may also include a tissue-gripping surface (which may also be formed of wire). For example, a clamping apparatus for delivering pulsed electrical energy may include a first jaw, a first electrode comprising an elongate wire electrode extending along the first jaw, wherein the first electrode forms a first tissue-gripping surface, a second jaw that is opposite from the first jaw, a second electrode on the second jaw, an actuator configured to adjust a separation between the first jaw and the second jaw. The applicator may further comprise a connector at a proximal end of the clamping apparatus configured to form an electrical connection between a pulse generator and the first and second electrodes.

[0109] As mentioned above, the apparatuses described herein may include a tissue grip(e.g., tissue gripping surface) on just one of the jaws, rather than on both jaws. Any of theseapparatuses may include a tissue grip on both jaws, but having different types of tissue grip (e.g., grooved, mesh, wire, etc.) on the jaws. For example, an apparatus may include a first jaw with a first tissue grip that is a mesh tissue grip and a second jaw with a second tissue grip that is a wire tissue grip. Similarly, the tissue grips on the opposite jaws may be of the same type, but different dimensions. For example, the first jaw may have a wire grip formed of one or more lengths of wire, and the second jaw may have a wire grip formed of a different gauge wire and / or a different number of wires.

[0110] In general, the tissue grips may be formed of an electrically conductive material of the electrodes, and in some cases may be integrated with the electrodes. In some cases, the conductive material may be formed of silver, platinum, nickel titanium, conducive polymer, etc. In apparatuses in which the conductive tissue grip is attached or integrated into a conducive base or support, the conductive base or support may be the same or a different material. In any of the examples described herein the one or more electrodes (including any grip region of the electrode, which is conductive) on a first jaw of the apparatus may all be the same polarity, and the one or more electrodes (including any grip region of the electrode, which is conductive) on the second jaw are of an opposite polarity, grips may be fully conductive and may not include any non-conductive material.[OHl] The apparatuses described herein may be fabricated by any appropriate method. In particular, the electrically conductive gripping surface may be fabricated either directly as part (or all) of the electrode, or it may be attached to an electrode. In some cases, the grip region may be coupled to the base of the jaws by an adhesive and / or by a mechanical attachment. The jaw(s) may be formed of a generally electrically insulative material such as a polymeric material, for example, a polyimide, PEEK (polyether ether ketone), FEP (fluorinated ethylene propylene), PFA (Perfluoroalkoxy alkane), PPSU (polyphenyl sulfone), etc. The jaws may be injection molded, blow molded, etc. The jaws may include an attachment region for attaching the electrode and / or the grip region forming all or a portion of the electrode. The jaws and / or handle may be formed by any technique. In some cases, the handle and / or jaws may be formed by a three-dimensional (3D) printing technique, such as an additive technique (e.g., directed energy deposition, powder bed fusion, binder jetting, sheet lamination, material extrusion, material jetting, vat polymerization, fused deposition modeling, etc.). In some cases, the jaws and / or handle may be formed by a subtractive process, such as such as a CNC machine (lathe, milling machine, plasma cutter, etc.), a wire EDM, etc. In some cases, the jaws and / or handle may be formed to include an overmolded region for the electrode / grip.

[0112] In some cases, the electrical connection between a connector to the pulse generator and to the grip region (electrode) may include a wire or electrical trace that is connected to the jaw(s), e.g., by an adhesive mechanical attachment, etc.

[0113] The grip region may be formed in any appropriate manner. For example, a wire electrode grip region may be formed by bending or shaping the wire, e.g., using a wire bending machine. Optionally, the shape of the wire electrode grip may be shape-set, e.g., into a compact configuration. The shaped wire grip region may either be directly coupled to the jaw(s), or it may be coupled to an electrode (e.g., a plate electrode) that has also already been coupled to the jaw. This may be repeated for each jaw. The shaped wire grip region may be directly attached to the jaw, including the non-conductive region without an underlying electrode in some variations.

[0114] For example, a method of fabricating an apparatus, including a clamping apparatus having one or more electrically conductive grips may include forming a first jaw and a second jaw. A grip may be formed separately and coupled to a jaw. In some cases, both jaws may include a grip region. The grip region may be directly coupled to the jaw, or it may be coupled (electrically coupled) to an underlying electrode that is attached to the jaw. In some cases, the grip region may be formed directly into or onto the underlying electrode (e.g., plate electrode). For example, a grooved grip may be formed by cutting, shaping or otherwise deforming (e.g., laser cutting, pressing, milling, etc.) the surface of an electrode, such as a plate electrode, before or in some cases after it has been coupled to the jaw. In variations including a conductive mesh grip the mesh may be applied directly to the jaw, or it may be electrically coupled to an underlying electrode (e.g., plate).

[0115] As mentioned, if the electrically conductive grip is a wire grip, it may be formed by bending the conductive wire (which may be insulated in a region not part of the gripping surface, or may be un-insulated) to form the gripping surface and coupled either directly to the jaw (so that the wire acts as the electrode and also as a grip) or to an underling electrode that is coupled to the jaw (or both). An electrical conductor may be separately electrically coupled to the grip region and to the jaw to extend to a pulse generator. In some cases, the grip region may be formed of a wire, a portion of which forms the connector to electrically couple the grip to the pulse generator.

[0116] Optionally, the first and second jaws may be movably coupled together (e.g., via a pivot, hinge, slider, etc.).

[0117] FIG. 10 schematically illustrates one example of a method of forming an apparatus as described herein, including in particular an apparatus including a wire grip region. In FIG. 10, the method may first comprise fabricating a first jaw and a second jaw(1001). The first jaw and the second jaw each include a tissue-facing region (e.g., face). The first jaw and second jaw may be fabricated as described above, e.g., by a direct fabrication technique and / or by molding, etc. The first and second jaws may generally be fabricated from a non-conducive material.

[0118] The method may then include forming the electrically conductive grip region (grip or gripping region) (1003). In some cases, the grip region may be formed of a wire and may include bending or otherwise shaping the wire to form a gripping surface that is configured to contact and grip the tissue. Forming the grip when the grip comprises a wire may optionally include removing any insulation (e.g., covering insulation); insulation may be removed mechanically (e.g., by cutting), chemically, optically (e.g., laser), etc. in some cases the wire does not include an outer insulation. The method may further include bending the wire to form a pattern to be positioned on or across the jaw. In some cases, this may include forming a plurality of bends (e.g., two bends, three bends, etc.). The bends may be performed so that lengths of wire are formed to extend along the jaw region to form the tissue-contacting surface. In some cases, the wire may instead or additionally be wrapped (e.g., into a helical pattern). In some cases, the wrap may be flattened on one or more sides. In some cases, the wire may be bent so the lengths of wire extend in a single plane. In some cases, the wire may be bent to form a stacked structure of lengths of wire, for example, as shown in FIG. 9A. The grip region may be formed of a single wire that is formed into the various adjacent lengths (e.g., by bending, wrapping, etc.) or the grip region may be formed or a plurality of wires forming the multiple lengths (e.g., wors) of wire.

[0119] The fabrication method may then include coupling the gripping region (e.g., the lengths of wire) to the jaw (1005). In some cases, this may include coupling the gripping region to an underlying electrode (e.g., a plate electrode) which may support the wire and may be in electrical contact with the wire. Alternatively, the lengths of wire forming the grip region may be directly coupled to the jaw. The length of wire forming the gripping region may be coupled adhesively and / or mechanically to the jaw.

[0120] This process may be performed in parallel or may be repeated for the second jaw, in variations including grips on both jaws. The electrically conductive grip may be electrically coupled to a connector, such as a plug jack, etc. extending from the jaws to a proximal region (e.g., on a handle). The first grip region (or a first electrode) may be configured to be a cathode and the second grip region (or a second electrode) may be configured to act as the anode.

[0121] In some cases, the jaws (first jaw and second jaw) may be movably coupled relative to each other, for example, either or both of the jaws may be movably coupled to theelongate body (1007). Alternatively, the gripping regions may be coupled to the jaws after they are movably connected to each other, so that the jaws may open and close. The finished device may be sterilized and / or packaged.

[0122] In general, any of these apparatuses may be used to treat tissue, including but not limited to, heart tissue. For example, FIG. 11 schematically illustrates an example of a method of treating tissue using any of these apparatuses of the present disclosure. Optionally, the apparatus (e.g., the distal end of the applicator) may be positioned near the target tissue. This may be performed using an open surgical technique, or a minimally invasive technique. The tissue may be positioned between the jaws of the apparatus (1101), where the apparatus includes jaw electrodes forming tissue-gripping surfaces, as described above. The jaws may then be closed over the target tissue (1103). In some cases, the jaws may be closed by advancing one jaw towards the other jaw, and / or moving the two jaws towards each other. In some cases, the jaws may be advanced towards each other by sliding a shaft to which the jaw is connected distally or proximally relative to the other jaw, allowing parallel closing (e.g., in a caliper-like configuration). In some cases, the jaws may be moved in a scissoring action. The tissue-gripping surface(s) of the electrode(s) may engage with and grip the tissue (1103). Once the tissue is secured, e.g., gripped, by the tissue-gripping surface(s) of the electrodes, energy may be applied (1105), such as sub-microsecond electrical pulses having an amplitude of at least 0.1 kV., at least 5 kV, at least 10 kV. etc.

[0123] As mentioned above, any appropriate target tissue may be treated, including heart, pulmonary veins, pharynx, esophagus, stomach, small intestine, large intestine, liver, gallbladder, mesentery, pancreas, larynx, trachea, bronchia, lungs, diaphragm, kidney, bladder, urethra, ovaries, fallopian tubes, uterus, vagina, testes, epididymis, vas deferens, prostate, bulbourethral glands, pituitary gland, pineal gland, thyroid gland, adrenal glands, arteries, veins, lymph nodes, lymphatic vessel, spleen, thymus, skin, eyelids, lips, tongue, ear, nose, vocal cords, etc.

[0124] In use, the electrodes forming the tissue-gripping surfaces may provide significant contact with the tissue, while holding the tissue securely even when the tissue is slippery and difficult to grasp, particularly without applying too much force (e.g., crushing force). As described above, the tissue-gripping surfaces formed by the electrodes may be configured to prevent or limit arcing. Similarly, these tissue-gripping surfaces may be configured to apply a relatively constant filed strength over the tissue being treated, e.g., between the electrodes including the gripping surface(s).

[0125] In any of these apparatuses the individual electrodes of the plurality of electrodes, on either or both the first jaw and the second jaw, may be individually controlled and maytherefore be independently wired or they may be collectively connected (e.g., wired). Either or both the first jaw and the second jaw may be used to apply an electric field through the tissue, e.g., to create a lesion in the target tissue. If both the first and second jaws include a plurality of electrodes, then both the first and second jaws may be used to create the electric field. Alternatively, electrode pairs on just one jaw can be activated to apply an electric field and / or treat a tissue between the jaws from one side only. In operation these applicators may apply an electric field that may penetrate into the tissue and the decaying electrical field may cause killing of cells / tissue. Depending on the pulse duration and applied energy, cells death may be triggered non-thermally, e.g., up to an electric field threshold; electric fields stronger than this threshold may kill the cells, and electric fields weaker than this threshold may not kill the cells. The magnitude of the field threshold may be a function of the energy delivered.

[0126] Any of the apparatuses described herein may include software (e.g., programs) for performing any of the methods described above. For example, these apparatuses may include non-transitory computer-readable storage medium storing a set of instructions capable of being executed by a processor (e.g., a controller, such as the energy controller) to perform any of these methods.

[0127] All publications and patent applications mentioned in this specification are herein 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. Furthermore, it should be appreciated that all combinations of the concepts of the present disclosure (provided such concepts are not mutually inconsistent) are contemplated as being part of the inventive subject matter disclosed herein and may be used to achieve the benefits described herein.

[0128] Any of the methods (including user interfaces) described herein may be implemented as software, hardware or firmware, and may be described as a non-transitory computer-readable storage medium storing a set of instructions capable of being executed by a processor (e.g., computer, tablet, smartphone, etc.), that when executed by the processor causes the processor to control perform any of the steps, including but not limited to: displaying, communicating with the user, analyzing, modifying parameters (including timing, frequency, intensity, etc.), determining, alerting, or the like. For example, any of the methods described herein may be performed, at least in part, by an apparatus including one or more processors having a memory storing a non-transitory computer-readable storage medium storing a set of instructions for the processes(s) of the method.

[0129] While various embodiments have been described and / or illustrated herein in the context of fully functional computing systems, one or more of these example embodimentsmay be distributed as a program product in a variety of forms, regardless of the particular type of computer-readable media used to actually carry out the distribution. The embodiments disclosed herein may also be implemented using software modules that perform certain tasks. These software modules may include script, batch, or other executable files that may be stored on a computer-readable storage medium or in a computing system. In some embodiments, these software modules may configure a computing system to perform one or more of the example embodiments disclosed herein.

[0130] As described herein, the computing devices and systems described and / or illustrated herein broadly represent any type or form of computing device or system capable of executing computer-readable instructions, such as those contained within the modules described herein. In their most basic configuration, these computing device(s) may each comprise at least one memory device and at least one physical processor.

[0131] The term “memory” or “memory device,” as used herein, generally represents any type or form of volatile or non-volatile storage device or medium capable of storing data and / or computer-readable instructions. In one example, a memory device may store, load, and / or maintain one or more of the modules described herein. Examples of memory devices comprise, without limitation, Random Access Memory (RAM), Read Only Memory (ROM), flash memory, Hard Disk Drives (HDDs), Solid-State Drives (SSDs), optical disk drives, caches, variations or combinations of one or more of the same, or any other suitable storage memory.

[0132] As used herein, a processor may include hardware that runs the computer program code. Specifically, the term ‘processor’ may include a controller and may encompass not only computers having different architectures such as single / multi-processor architectures and sequential (Von Neumann) / parallel architectures but also specialized circuits such as field- programmable gate arrays (FPGA), application specific circuits (ASIC), signal processing devices and other devices. In addition, the term “processor” or “physical processor,” as used herein, generally refers to any type or form of hardware-implemented processing unit capable of interpreting and / or executing computer-readable instructions. In one example, a physical processor may access and / or modify one or more modules stored in the above-described memory device. Examples of physical processors comprise, without limitation, microprocessors, microcontrollers, Central Processing Units (CPUs), Field-Programmable Gate Arrays (FPGAs) that implement softcore processors, Application-Specific Integrated Circuits (ASICs), portions of one or more of the same, variations or combinations of one or more of the same, or any other suitable physical processor.

[0133] Although illustrated as separate elements, the method steps described and / or illustrated herein may represent portions of a single application. In addition, in some embodiments one or more of these steps may represent or correspond to one or more software applications or programs that, when executed by a computing device, may cause the computing device to perform one or more tasks, such as the method step.

[0134] In addition, one or more of the devices described herein may transform data, physical devices, and / or representations of physical devices from one form to another. Additionally or alternatively, one or more of the modules recited herein may transform a processor, volatile memory, non-volatile memory, and / or any other portion of a physical computing device from one form of computing device to another form of computing device by executing on the computing device, storing data on the computing device, and / or otherwise interacting with the computing device.

[0135] The term “computer-readable medium,” as used herein, generally refers to any form of device, carrier, or medium capable of storing or carrying computer-readable instructions. Examples of computer-readable media comprise, without limitation, transmission-type media, such as carrier waves, and non-transitory-type media, such as magnetic-storage media (e.g., hard disk drives, tape drives, and floppy disks), optical-storage media (e.g., Compact Disks (CDs), Digital Video Disks (DVDs), and BLU-RAY disks), electronic-storage media (e.g., solid-state drives and flash media), and other distribution systems.

[0136] A person of ordinary skill in the art will recognize that any process or method disclosed herein can be modified in many ways. The process parameters and sequence of the steps described and / or illustrated herein are given by way of example only and can be varied as desired. For example, while the steps illustrated and / or described herein may be shown or discussed in a particular order, these steps do not necessarily need to be performed in the order illustrated or discussed.

[0137] The various exemplary methods described and / or illustrated herein may also omit one or more of the steps described or illustrated herein or comprise additional steps in addition to those disclosed. Further, a step of any method as disclosed herein can be combined with any one or more steps of any other method as disclosed herein.

[0138] The processor as described herein can be configured to perform one or more steps of any method disclosed herein. Alternatively or in combination, the processor can be configured to combine one or more steps of one or more methods as disclosed herein.

[0139] When a feature or element is herein referred to as being "on" another feature or element, it can be directly on the other feature or element, or intervening features and / orelements may also be present. In contrast, when a feature or element is referred to as being "directly on" another feature or element, there are no intervening features or elements present. It will also be understood that, when a feature or element is referred to as being "connected", "attached" or "coupled" to another feature or element, it can be directly connected, attached or coupled to the other feature or element or intervening features 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 present. Although described or shown with respect to one embodiment, the features and elements so described or shown can apply to other embodiments. It will also be appreciated by those of skill in the art that references to a structure or feature that is disposed "adjacent" another feature may have portions that overlap or underlie the adjacent feature.

[0140] Terminology used herein is for the purpose of describing particular embodiments only and is 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. It will be further understood that the terms "comprises" and / or "comprising," when used in this specification, specify the presence of 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. As used herein, the term "and / or" includes any and all combinations of one or more of the associated listed items and may be abbreviated as " / ".

[0141] Spatially relative terms, such as "under", "below", "lower", "over", "upper" and the like, may be used herein for ease of description to describe one element or feature's relationship to another element(s) or feature(s) as illustrated in the figures. It will be understood that the spatially relative terms are intended to encompass different orientations of the device in use or operation in addition to the orientation depicted in the figures. For example, if a device in the figures is inverted, elements described as "under”, or "beneath" other elements or features would then be oriented "over" the other elements or features. Thus, the exemplary term "under" can encompass both an orientation of over and under. The device may be otherwise oriented (rotated 90 degrees or at other orientations) and the spatially relative descriptors used herein interpreted accordingly. Similarly, the terms "upwardly", "downwardly", "vertical", "horizontal" and the like are used herein for the purpose of explanation only unless specifically indicated otherwise.

[0142] Although the terms “first” and “second” may be used herein to describe various features / elements (including steps), these features / elements should not be limited by these terms, unless the context indicates otherwise. These terms may be used to distinguish onefeature / element from another feature / element. Thus, a first feature / element discussed below could be termed a second feature / element, and similarly, a second feature / element discussed below could be termed a first feature / element without departing from the teachings of the present invention.

[0143] In general, any of the apparatuses and methods described herein should be understood to be inclusive, but all or a sub-set of the components and / or steps may alternatively be exclusive and may be expressed as “consisting of’ or alternatively “consisting essentially of’ the various components, steps, sub-components or sub-steps.

[0144] As used herein in the specification and claims, including as used in the examples and unless otherwise expressly specified, all numbers may be read as if prefaced by the word "about" or “approximately,” even if the term does not expressly appear. The phrase “about” or “approximately” may be used when describing magnitude and / or position to indicate that the value and / or position described is within a reasonable expected range of values and / or positions. For example, a numeric value may have a value that is + / - 0.1% of the stated value (or range of values), + / - 1% of the stated value (or range of values), + / - 2% of the stated value (or range of values), + / - 5% of the stated value (or range of values), + / - 10% of the stated value (or range of values), etc. Any numerical values given herein should also be understood to include about or approximately that value, unless the context indicates otherwise. For example, if the value " 10" is disclosed, then "about 10" is also disclosed. Any numerical range recited herein is intended to include all sub-ranges subsumed therein. It is also understood that when a value is disclosed that "less than or equal to" the value, "greater than or equal to the value" and possible ranges between values are also disclosed, as appropriately understood by the skilled artisan. For example, if the value "X" is disclosed the "less than or equal to X" as well as "greater than or equal to X" (e.g., where X is a numerical value) is also disclosed. It is also understood that throughout the application, data is provided in a number of different formats, and that this data represents endpoints and starting points, and ranges for any combination of the data points. For example, if a particular data point “10” and a particular data point “15” are disclosed, it is understood that greater than, greater than or equal to, less than, less than or equal to, and equal to 10 and 15 are considered disclosed as well as between 10 and 15. It is also understood that each unit between two particular units are also disclosed. For example, if 10 and 15 are disclosed, then 11, 12, 13, and 14 are also disclosed.

[0145] Although various illustrative embodiments are described above, any of a number of changes may be made to various embodiments without departing from the scope of the invention as described by the claims. Optional features of various device and systemembodiments may be included in some embodiments and not in others. Therefore, the foregoing description is provided primarily for exemplary purposes and should not be interpreted to limit the scope of the invention as it is set forth in the claims.

[0146] The examples and illustrations included herein show, by way of illustration and not of limitation, specific embodiments in which the subject matter may be practiced. As mentioned, other embodiments may be utilized and derived there from, such that structural and logical substitutions and changes may be made without departing from the scope of this disclosure. Such embodiments of the inventive subject matter may be referred to herein individually or collectively by the term “invention” merely for convenience and without intending to voluntarily limit the scope of this application to any single invention or inventive concept, if more than one is, in fact, disclosed. Thus, although specific embodiments have been illustrated and described herein, any arrangement calculated to achieve the same purpose may be substituted for the specific embodiments shown. This disclosure is intended to cover any and all adaptations or variations of various embodiments. Combinations of the above embodiments, and other embodiments not specifically described herein, will be apparent to those of skill in the art upon reviewing the above description.

Claims

CLAIMSWhat is claimed is:

1. An apparatus for delivering pulsed electrical energy, the apparatus comprising: a first jaw; a first electrode on the first jaw, wherein the first electrode comprises or forms a first tissue-gripping surface; a second jaw that is opposite from the first jaw; a second electrode on the second jaw; an actuator configured to adjust a separation between the first jaw and the second jaw; and a connector at a proximal end of the apparatus configured to form an electrical connection between a pulse generator and the first and second electrodes.

2. An apparatus for delivering pulsed electrical energy, the apparatus comprising: a first jaw; a first electrode comprising an elongate wire extending along at least a portion of the first jaw, wherein the first electrode is configured to form a first tissuegripping surface; a second jaw that is opposite from the first jaw; a second electrode on the second jaw; an actuator configured to adjust a separation between the first jaw and the second jaw; and a connector at a proximal end of the apparatus configured to form an electrical connection between a pulse generator and the first and second electrodes.

3. The apparatus of claims 1 or 2, wherein the second electrode comprises or forms a second tissue-gripping surface.

4. The apparatus of claim 1, wherein the first electrode comprises an elongate wire extending along at least a portion of a length of the first jaw to form the first tissuegripping surface.

5. The apparatus of claims 1 or 2, wherein the second electrode comprises a second elongate wire extending along at least a portion of a length of the second jaw to form a second tissue-gripping surface.

6. The apparatus of claims 2 or 4, wherein the second electrode comprises a second elongate wire arranged on the second jaw to mirror the elongate wire on the first jaw.

7. The apparatus of claims 2 or 4, wherein the elongate wire extends back and forth along at least a portion of the length of the first jaw in two or more adjacent lines.

8. The apparatus of any of claims 2 or 4-7, wherein the elongate wire has a rounded cross-sectional profile with a diameter of between about 0.5mm and about 2mm, optionally wherein the elongate wire has a length that is at least three-fold greater than its diameter.

9. The apparatus of claim 7, wherein the first tissue-gripping surface comprises an adjustable size gripping surface.

10. The apparatus of claim 7, wherein the first tissue-gripping surface comprises multiple stacked lengths of the elongate wire configured to be converted into a single layer of the lengths of the elongate wire based on a pressure applied by the first and second jaws against a tissue and / or against each other.

11. The apparatus of claims 1 or 2, wherein the first tissue gripping surface comprises one or more grooves.

12. The apparatus of claims 1 or 2, wherein the first tissue gripping surface comprises one or more protrusions extending proud of a tissue-contacting surface of the first electrode.

13. The apparatus of claim 3, wherein the first tissue gripping surface is configured to mate with the second tissue-gripping surface in a female-to-male engagement, female- to-female engagement or male-to-male engagement.

14. The apparatus of any of claims 2, 4, 6-10, wherein the elongate wire comprises a nickel titanium alloy, gold, silver, platinum, or stainless steel.

15. The apparatus of claims 1 or 2, wherein at least one of the first electrode and the second electrode comprises an electrically conductive mesh or a grid-like gripping pattern extending over a surface of the first jaw or the second jaw, respectively, to form the first tissue-gripping surface or a second tissue-gripping surface.

16. The apparatus of claim 15, wherein the electrically conductive mesh or the grid-like gripping pattern comprises a lattice having a gap size of 1 cm or less between adjacent strands forming the mesh or the gripping pattern.

17. The apparatus of claim 1, wherein the first electrode extends over at least a portion of a surface of the first jaw and wherein one or more first tissue grips extend into, or from, a tissue-contacting surface of the first electrode, so that the tissue-contacting surface of the first electrode surrounds the one or more first tissue grips.

18. The apparatus of claim 17, further wherein the second electrode extends over at least a portion of a surface of the second jaw and wherein one or more second tissue grips extend into, or from, a tissue-contacting surface of the second electrode, so that the tissue-contacting surface of the second electrode surrounds the one or more first tissue grips.

19. The apparatus of any of claims 1-18, wherein the first jaw and the second jaw extend in a curved length.

20. The apparatus of any of claims 1-19, wherein the first jaw and the second jaw are configured to open and close substantially in parallel.

21. The apparatus of any of claims 1-20, wherein the connector is configured to connect to the pulse generator configured to deliver electrical pulses having an amplitude of at least 0.1 kV.

22. A clamping apparatus for delivering pulsed electrical energy, the apparatus comprising: a first jaw; a first electrode comprising a first conductive mesh or a grid-like gripping pattern on a tissue-contacting surface of the first jaw, wherein the first conductive mesh is configured to form a first tissue-gripping surface; a second jaw that is opposite from the first jaw; a second electrode on a tissue-contacting surface of the second jaw; an actuator configured to adjust a separation between the first jaw and the second jaw; and a connector at a proximal end of the clamping apparatus configured to form an electrical connection between a pulse generator and the first and second electrodes.

23. An apparatus for delivering pulsed electrical energy, the apparatus comprising: a clamping applicator comprising: a first jaw; a first electrode comprising a first elongate wire electrode extending along at least a portion of a length of the first jaw in a first pattern configured to form a first tissue-gripping surface; a second jaw that is opposite from the first jaw; a second elongate wire electrode extending from the second jaw in a second pattern; an actuator configured to adjust a separation between the first jaw and the second jaw; and a connector at a proximal end of the apparatus configured to form an electrical connection between a pulse generator and the first and second electrodes; and the pulse generator configured to provide electrical pulses having an amplitude of at least 0.1 kV.

24. An apparatus for delivering pulsed electrical energy, the apparatus comprising: a first jaw; a first electrode extending over the first jaw; one or more first tissue grips extending into or from a tissue-contacting surface of the first electrode so that the tissue-contacting surface of the first electrode surrounds the one or more first tissue grips; a second jaw that is opposite from the first jaw; a second electrode extending over second jaw; one or more second tissue grips extending into or from a tissue-contacting surface of the second electrode so that the tissue-contacting surface of the second electrode surrounds the one or more second tissue grips; an actuator configured to adjust a separation between the first jaw and the second jaw; and a connector at a proximal end of the apparatus configured to form an electrical connection between the first and second electrodes and an outside source of electrical energy.

25. A method, the method comprising:positioning a tissue between a first and a second jaws of a clamping applicator so that the tissue is gripped by an electrically conductive gripping region on one or both jaws, wherein the electrically conductive gripping region comprises a plurality of lengths of a wire electrode that is electrically coupled together and arranged adjacent to each other; holding the tissue between the first and second jaws in electrical contact while the tissue is gripped by the gripping region; and applying pulsed electrical energy between the first and second jaws from the electrically conductive gripping region.

26. The method of claim 25, wherein applying pulsed electrical energy comprises applying pulsed energy having an amplitude of at least 0.1 kV.

27. The method of claims 25 or 26, wherein applying pulsed electrical energy comprises applying sub-microsecond electrical pulses.

28. The method of any of claims 25-27, wherein the plurality of lengths of the wire electrode is arranged along a tissue-contacting surface of at least one of the first jaw and the second jaw as multiple stacked lengths of wire configured to slide over and against each other when tension or force is applied.

29. The method of any of claims 25-28, wherein holding the tissue between the first and second jaws comprises holding the tissue between electrically conductive gripping regions on both jaws.

30. The method of claim 28, further comprising applying a force to the multiple stacked lengths of wire to displace one or more of the lengths of wire to enlarge a region between the first and second jaws that is in electrical contact with the tissue.

31. The method of any of claims 25-30, wherein the tissue is one of heart, pulmonary veins, pharynx, esophagus, stomach, small intestine, large intestine, liver, gallbladder, mesentery, pancreas, larynx, trachea, bronchia, lungs, diaphragm, kidney, bladder, urethra, ovaries, fallopian tubes, uterus, vagina, testes, epididymis, vas deferens, prostate, bulbourethral glands, pituitary gland, pineal gland, thyroid gland, adrenal glands, arteries, veins, lymph nodes, lymphatic vessel, spleen, thymus, skin, eyelids, lips, tongue, ear, nose, vocal cords.

32. A method of forming an applicator having an electrically conductive grip, the method comprising: fabricating a first jaw and a second jaw; forming a first electrically conductive grip region by bending or shaping one or more wires to form a first plurality of lengths of wire that are arranged adjacent to each other; coupling the first electrically conductive grip region to the first jaw; coupling a second electrically conductive grip region comprising a second plurality of lengths of wire that are arranged adjacent to each other to the second jaw; and coupling the first and second jaws to each other or to a body of the applicator such that at least one of the first and second jaws may move relative to each other.

33. The method of claim 32, wherein the first and second jaws are coupled to each other prior to coupling the first electrically conductive grip region to the first jaw.

34. The method of claims 32 or 33, wherein the first jaw comprises a first electrode and wherein coupling the first electrically conductive grip region to the first jaw comprises coupling the first electrically conductive grip region to the first electrode.

35. The method of claims 32 or 33, wherein the first electrically conductive grip region forms a first electrode, and the second electrically conductive grip region forms a second electrode.

36. The method of claims 32 or 33, wherein forming the first electrically conductive grip region comprises bending the one or more wires to form the first plurality of lengths of wire so that the first plurality of lengths of wires is arranged adjacent to each other to form a tissue contacting surface comprising curved sides of the first plurality of lengths of wires.

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