Clamp-type electrode apparatuses and methods

Abstract

Apparatuses and methods for applying energy across a wall of an organ or tissue, including (but not limited to) the soft tissue, heart tissue, esophagus, stomach, colon, intestine, or reproductive organs. In general, these apparatuses and corresponding methods allow an improved positioning of a target tissue between a tissue-contacting member and electrode positioning member in order to apply electric field to the target tissue.

Description

CLAMP-TYPE ELECTRODE APPARATUSES AND METHODSCLAIM OF PRIORITY

[0001] This patent application claims priority to U.S. provisional patent application no.63 / 752,600, titled “CLAMP-TYPE ELECTRODE APPARATUSES AND METHODS,” filed on January 31, 2025, herein incorporated by reference in its entirety.BACKGROUND

[0002] It may be particularly helpful when applying electrical energy to a tissue to apply the energy between electrodes on either sides of the tissue being treated. For example, applying electrical energy to a heart tissue may be useful to treat conditions involving abnormal electrical activity within the heart, such as arrhythmias. For example, the endocardium, the innermost layer of the heart, houses critical conductive pathways and nodes, including the sinoatrial (SA) and atrioventricular (AV) nodes, which regulate the heart's electrical impulses. Controlled electrical energy may be applied to the heart tissue to selectively modify or destroy areas that are causing erratic or harmful electrical signals, restoring a healthy rhythm. For example, atrial fibrillation is a type of abnormal heart rhythm that occurs in the heart’s upper two chambers, known as the atria, while ventricular fibrillation is a type of abnormal heart rhythm that occurs in the heart’s lower two chambers, known as the ventricles. Ablation can create scar tissue to block the abnormal electrical signals, effectively eliminating the source of the arrhythmia. This approach not only alleviates symptoms but also reduces the risk of serious complications like stroke and heart failure, offering a potentially curative treatment for many patients.

[0003] While it is common to perform ablation procedures using catheter-based ablation to achieve targeted treatment of problematic areas while preserving surrounding healthy tissue, it may be difficult to target tissue by applying energy between electrodes on either side of the tissue. For example, in reference to the cardiac surgeries, currently purse strings are used to create ablation lines of the endocardium and epicardium. The purse string is a set of sutures placed around the incision site to help seal the incision when complete. This process, however, can cause large leaks or accidentally break the suture in the process of sealing it. It would be helpful to provide apparatuses and techniques that may improve and simplify these treatments. The methods and apparatuses described herein may address this need.SUMMARY OF THE DISCLOSURE

[0004] The apparatuses (e.g., devices and systems) and methods described herein may - 1 - SG Docket No.: 14567-736.600 / 133 PCTdeliver energy to both sides of an organ or tissue, including in difficult to reach areas. Such apparatuses and methods may be used, for example and without limitation, in treating heart arrhythmias, such as atrial or ventricular fibrillation. Moreover, such apparatuses and methods allow accomplishing this goal without a need to use a purse string. Generally, the apparatuses of the present disclosure may comprise an elongated body and a tissue-contacting member having one or more electrodes; the tissue-contacting member may extend, or may be configured to extend, outward at an angle from a distal end of the elongate body.Additionally, the apparatus may include a tissue penetrator (e.g., needle, lance, cannula, etc.) that is capable of extending beyond the elongated body and an electrode positioning member (e.g., wire, arm, strut, mesh, etc.) that is configured to deploy distally from the tissue penetrator. The tissue penetrator may extend and retract from / into the elongate body. The electrode positioning member may extend through the tissue penetrator and assume a shape and / or direction, for example, roughly parallel to the tissue-contacting member and may form or may include one or more electrodes.

[0005] These apparatuses may, therefore, be inserted through a wall of tissue or organ (e.g., a body lumen tissue, heart, esophagus, stomach, colon, intestine, abdominal tissue, reproductive organs, etc.) and may be deployed so that the tissue-contacting member (e.g., arm, plate, mesh, etc.) is positioned on one side of the wall or one side of a target tissue and the electrode positioning member (e.g., wire, loop, basket, mesh, etc.) is positioned on the other or opposite side. The tissue-contacting member and the electrode positioning member may be clamped onto the wall / target tissue such that one or more electrodes of the tissuecontacting member and the one or more electrodes of the electrode positioning member are on the opposite sides of the wall / target tissue so that current can be applied between them to ablate the target tissue. The apparatus may be positioned with minimal trauma to the tissue / wall of tissue, and may be easily and efficiently manipulated and operated. This may simplify treatment of the tissue and may minimize damage to the tissue (e.g., wall of the tissue or organ). These methods and apparatuses may generally be used for ablation of tissue from both side of a tissue or organ wall, including but not limited to cardiac tissue. When treating heart tissue, the treatment may be referred to as transcardial. Non-limiting examples of other procedures may include, but are not limited to, ablation, for example, of various organs and tissue, such as soft tissue, esophagus, rectum, stomach, bladder, intestinal track, uterus, etc.

[0006] In general, these clamping devices may be referred to herein as applicators (e.g., electrical applicators) and / or as clamp-type applicators. According to some implementations, an applicator of the present disclosure may comprise: An apparatus comprising: an elongate -2 - SG Docket No.: 14567-736.600 / 133 PCTbody; a tissue-contacting member extending or configured to extend outward at an angle from a distal end region of the elongate body, the tissue-contacting member comprising one or more electrodes; a tissue penetrator configured to extend distally from the elongate body and to retract proximally into the elongate body; and an electrode positioning member comprising one or more electrodes, the electrode positioning member may be configured to extend distally through the tissue penetrator and, upon deployment from the distal end of the tissue penetrator, assume a tissue-contacting shape and / or direction extending adjacent to the tissue-contacting member and separated by a gap configured to hold a tissue therebetween. In some examples, the direction is approximately parallel to the tissue-contacting member.

[0007] Any of these apparatuses or applicators described herein may also include a guide (e.g., a tube or cannula) that may form a part of the apparatus. For example, the guide may fit into or over the tissue penetrator, and in some cases may deflect the tissue penetrator and / or the electrode positioning member, so that it can be positioned against the wall of tissue and opposite the tissue-contacting member. However, in some cases the tissue penetrator may include a deflection surface instead or in addition to the guide.

[0008] When deployed, in some examples, the electrode(s) of the tissue-contacting member may align opposite the electrode(s) of the electrode positioning member, with the tissue situated between them. In some configurations, the spacing between the tissuecontacting member and the electrode positioning member may be adjustable to ensure the tissue is securely held, for example, in contact with the electrodes on both sides. Electrical energy can then be applied between the electrodes on either side to treat the target tissue effectively. For example, the apparatus may include a handle with one or more controls, e.g., a proximal handle, which may include a clamp control that may move either the electrode positioning member and / or the tissue-contacting member relative to each other (closer and / or further apart) to clamp / unclamp the tissue therebetween. In some cases the clamp control may drive the electrode positioning member proximally, e.g., after the tissue penetrator and / or guide has been withdrawn proximally (e.g., back into the elongate body and / or tissuecontacting member), bringing the electrode positioning member closer towards the target tissue on the opposite side from the tissue-contacting member.

[0009] In general, the electrode positioning member may be insulated except over the exposed electrode portion. In some cases the electrode positioning member comprises a wire that is insulated except over a region forming the exposed one or more electrodes (e.g., a longitudinal length, one or more discrete regions / points, one side / tissue-facing side, etc.). Alternatively or additionally, any of these apparatuses may include an insulative sleeve. In some cases the electrode positioning member may comprise a partially or completely-3 - SG Docket No.: 14567-736.600 / 133 PCTuninsulated wire (e.g., nickel-titanium, such as Nitinol wire) that is axially movable (along its length) relative to the electrically insulating sleeve. The electrode positioning member may include the electrically insulating sleeve or the electrically insulating sleeve may be separate from the electrode positioning member. In some cases, the electrode positioning member may comprise a mesh, for example, a Nitinol mesh.

[0010] In some cases the apparatus may include a deflector, for example, a guide that is configured as a sleeve, e.g., an insulating sleeve. For example, the guide may be configured to direct the electrode positioning member as it extends distally out of the elongate shaft, including bending or deflecting the electrode positioning member so that it extends parallel to the tissue-contacting member; the guide may also act as an insulating sleeve that fits (in some cases fits snugly) over the electrode positioning member. Alternatively, in any of these methods and apparatuses the sleeve may be a separate element; in some examples the sleeve may also pass through, and be directed by, a guide and / or deflector.

[0011] According to some implementations, the apparatuses of the present disclosure may comprise: an elongate body; a tissue-contacting member extending or configured to extend laterally outward from a distal end region of the elongate body and contact a first side of a target tissue, wherein the tissue-contacting member comprises one or more electrodes; a tissue penetrator configured to extend distally from the elongate body and the tissuecontacting member, and to retract proximally into the elongate body; and an electrode positioning member comprising one or more electrodes, wherein the electrode positioning member is configured to extend distally through the tissue penetrator and out to a side of the target tissue that is opposite to the first side and assume a direction along the opposite side of the target tissue.

[0012] The tissue-contacting member may extend or may be configured to extend perpendicularly or at a different angle from the distal end region of the elongate body. The tissue-contacting member may comprise a linear arm, a plurality of petals, a disk, an expandable basket or a mesh, an expandable funnel, etc.

[0013] In any of these apparatuses, the electrode positioning member may comprise a nickel-titanium alloy wire forming the one or more electrodes. The electrode positioning member may comprise an expandable basket or a mesh. The electrode positioning member may comprise one or more loops. The electrode positioning member may comprise an electrically conductive wire. The electrode positioning member may comprise an electrically conductive wire forming a single electrode.

[0014] As mentioned, any of these apparatuses may include an electrically insulating sleeve through which the electrode positioning member may extend, wherein the electrically - 4 - SG Docket No.: 14567-736.600 / 133 PCTinsulating sleeve is configured to extend distally from the elongate body and to retract proximally into the elongate body. Any of these apparatuses may comprise a guide and / or deflector to guide the electrode positioning member to assume a direction at an angle relative to the long axis of the elongated body. The guide may be configured as a sleeve, or the apparatus may include a separate sleeve. In some implementations instead of or in addition to the guide, the tissue penetrator may comprise a deflector having a deflecting surface.

[0015] Any of these apparatuses may include a clamp control configured to adjust a separation between the electrode positioning member and the tissue-contacting member. The clamp control may be on or part of a handle, such as a proximal handle. The apparatus may be configured as an apparatus for delivering energy across a wall of an organ, for example, as a trans-cardiac apparatus or clamp for delivering energy across a wall of a heart tissue (e.g., between endocardium and epicardium); however, these methods and apparatuses are not limited to treatment of cardiac tissue.

[0016] For example, any of these apparatuses may be configured as linear devices that may form linear treatments (e.g., linear ablation, etc. including substantially straight-line ablations). For example, an apparatus may include: an elongate body; a tissue-contacting member extending or configured to extend laterally outward from a distal end region of the elongate body wherein the tissue-contacting member comprises an arm having one or more electrodes on a tissue contacting surface of the arm; a tissue penetrator configured to extend distally from the elongate body and to retract proximally into the elongate body; an electrically conductive wire forming one or more electrodes and configured to extend distally through the tissue penetrator, wherein the electrically conductive wire is configured to assume a tissue-contacting shape upon deployment from a distal end of the tissue penetrator so that the electrically conductive wire extends laterally adjacent to and separate from the tissue-contacting member by a gap configured to hold a tissue therebetween; and an electrically insulating sleeve through which the electrically conductive wire extends distally and proximally, wherein the tissue penetrator, electrically conductive wire and the electrically insulating sleeve may all slide laterally relative to each other into and / or out of the distal end of the elongate body.

[0017] The tissue-contacting member may extend or may be configured to extend perpendicularly from the distal end region of the elongate body. As mentioned, the electrically conductive wire may comprise a nickel -titanium alloy wire forming the one or more electrodes. The electrically conductive wire may comprise one or more loops. The electrically conductive wire may form a single electrode. The electrically conductive wire may be configured to expand, for example, into a basket or mesh configuration upon- 5 - SG Docket No.: 14567-736.600 / 133 PCTdeployment from the distal end of the tissue penetrator so that the one or more electrodes of the electrically conductive wire are positioned on an opposite side of a tissue wall from the one or more electrodes of the tissue-contacting member.

[0018] In some cases the apparatus may include an expandable basket or mesh forming the tissue-contacting member upon deployment from an elongate body. In such configurations, the tissue-contacting member is configured to extend distally and retract proximally into the elongate body such that it is positioned in contact with a first side of a target tissue. In other implementations, the tissue-contacting member is configured to expand into a flower configuration having a plurality of petals / loops upon deployment from the elongate body such that the petals / loops are positioned in contact with a first side of the target tissue.

[0019] The electrode positioning member may comprise a nickel -titanium alloy wire or mesh forming the one or more electrodes. The electrically conductive wire or mesh may form a single electrode. The electrode positioning member may be configured to expand and assume a tissue-contacting shape upon deployment from the distal end of the tissue penetrator such that the one or more electrodes of the electrically conductive wire or mesh are positioned in contact with an opposite side of the target tissue across from the first side.

[0020] Also described herein are methods of making and using any of these apparatuses. For example, a method may include: positioning a tissue-contacting member of an apparatus against a first side of a tissue to be treated, the tissue-contacting member comprising first one or more electrodes; extending a tissue penetrator from an elongate body of the apparatus through the tissue to a side of the tissue opposite to the first side; passing or extending an electrode positioning member comprising second one or more electrodes through the tissue penetrator so that it extends from a distal end of the tissue penetrator and assumes a direction along the opposite side of the tissue; and applying energy between the first one or more electrodes on the first side of the tissue and the second one or more electrodes on the opposite side of the tissue.

[0021] Any of these methods may include expanding the electrode positioning member as it is extended from the tissue penetrator, wherein expanding comprises expanding to form one of: a basket, a funnel or a loop. Any of these methods may include clamping the tissue between the tissue-contacting member and the electrode positioning member. Extending the electrode positioning member through the tissue penetrator may comprise extending an insulative tube out of the tissue penetrator and at least partially around the electrode positioning member. The method may include retracting the tissue penetrator into the elongate member after extending the electrode positioning member through the tissue- 6 - SG Docket No.: 14567-736.600 / 133 PCTpenetrator. Any of these methods may include applying microsecond and / or sub-microsecond pulsed between the first one or more electrodes and the second one or more electrodes.

[0022] Any of the methods and apparatuses described herein may be specifically configured for treatment of cardiac tissue. For example, the methods and apparatuses described herein may be configured to treat cardiac arrhythmias by ablating cardiac tissue. In some examples, the methods described herein may include: positioning a tissue-contacting member of an apparatus against an endocardial surface of a cardiac tissue to be treated, the tissue-contacting member comprising first one or more electrodes; extending a tissue penetrator from an elongate body of the apparatus through the cardiac tissue to an epicardium; passing or extending an electrode positioning member comprising second one or more electrodes through the tissue penetrator so that it extends from a distal end of the tissue penetrator and assumes a shape and / or direction along the epicardium; and applying energy between the first one or more electrodes on the endocardial surface of the tissue and the second one or more electrodes on the epicardium. In some, for example, open heart surgery implementations, positioning of the apparatus may be reversed by first positioning a tissuecontacting member of the apparatus against an epicardial surface of the cardiac tissue, extending a tissue penetrator to the endocardial surface; passing or extending an electrode positioning member comprising second one or more electrodes through the tissue penetrator so that it extends from a distal end of the tissue penetrator and assumes a shape and / or direction along the endocardium; and applying energy between the electrodes on the endocardial and epicardial surfaces.

[0023] 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

[0024] 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:

[0025] FIGS. 1 A-1E illustrate one example of a clamp-type electrode apparatus of the present disclosure configured to apply energy, for example, across a wall of tissue. FIG. 1 A shows the apparatus fully deployed, with the electrode positioning member extended. FIGS.1B-1E illustrate deployment of the apparatus of FIG. 1A.

[0026] FIGS. 2A-2E illustrate an example of another electrode apparatus according to present disclosure having disk-shaped tissue-contacting member. FIG. 2A shows the- 7 - SG Docket No.: 14567-736.600 / 133 PCTapparatus fully deployed, with the electrode positioning member extended. FIGS. 2B-2E illustrate deployment of the apparatus of FIG. 2A.

[0027] FIG. 3 shows an example of a sectional view through a portion of a clamp-type electrode apparatus.

[0028] FIG. 4 is another example of a clamp-type electrode apparatus.

[0029] FIG. 5 schematically illustrates an example of a method of treating tissue using electrode apparatuses as described herein.

[0030] FIGS. 6A-6B show another example of an electrode apparatus having an expandable / deployable tissue-contacting member.

[0031] FIGS. 7A-7C show yet another example of an electrode apparatus having an expandable / deployable tissue-contacting member.

[0032] FIGS. 8A-8C show a further example of an electrode apparatus having an expandable / deployable tissue-contacting member (e.g., a mesh-type structure).DETAILED DESCRIPTION

[0033] Described herein are apparatuses (e.g., devices, systems, etc.) and methods for applying energy to both sides of an organ or tissue, such as (but not limited to) the heart, for example, in trans-cardiac applications. While the following descriptions refer to the heart or cardiac tissue, as an example only, the present disclosure is intended to cover apparatuses and methods for treatment of many other organs and tissue. In general, these apparatuses may include an elongate body with a tissue-contacting member or support comprising (e.g., holding, forming) one or more electrodes that extends, or is configured to extend, outward at an angle from a distal end region of the elongate body, a tissue penetrator (e.g., needle, lance, cannula, etc.) that can extend distal to the elongate body, and an electrode positioning member (e.g., wire, arm, strut, mesh, etc.) that includes one or more electrodes and is configured to extend distally out of the tissue penetrator to assume a direction that may be parallel or approximately parallel to the tissue-contacting support. When described herein as “parallel”, it is intended also to cover approximately parallel, or substantially parallel relative positions, such as, allowing for reasonable variances, minor imperfections or curvatures, including, for example, deviations at ±5, ±7, ±8, or ±10 degrees. These apparatuses may optionally include a guide (e.g., a tube or cannula) that may fit into or over the tissue penetrator and may have a distal end region that deflects the electrode positioning member so that it extends approximately parallel to the tissue-contacting support. Once deployed, the electrode(s) of the electrode positioning member may be positioned across the electrode(s) of the tissue-contacting member on the opposite side of the tissue. In some cases the spacing - 8 - SG Docket No.: 14567-736.600 / 133 PCTbetween the electrode positioning member and the tissue-contacting member may be adjusted so that the tissue is held between the two, and both sides of the tissue may be in contact with the electrodes. Electrical energy may be applied between the electrode(s) of the tissuecontacting member and the electrode(s) of the electrode positioning member to treat the tissue.

[0034] The tissue-contacting member may be any appropriate shape, and it may have a tissue-contacting surface. The overall shape may be elongate (e.g., an arm, strut, beam, mesh, etc.), rounded or oval, etc., and may be flattened. The tissue-contacting surface may be curved to better conform to the tissue. The surface area of the tissue-contacting surface may be between about 2 mm2and 100 mm2(e.g., between about 4 mm2and 100 mm2, between about 4 mm2and 90 mm2, between about 4 mm2and 80 mm2, between about 4 mm2and 70 mm2, between about 4 mm2and 50 mm2, etc.). The tissue-contacting member may include one or more electrodes that may extend along the length of the tissue-contacting member. In some cases the electrode(s) may form an array along the tissue-contacting member, in some cases, there may be a plurality of the discrete separate electrodes, or in some cases there may be just a single electrode.

[0035] The angle between the tissue-contacting member and the elongate body may be fixed (e.g., between 70 degrees and 140 degrees, such as 90 degrees, 95 degrees, etc.) or may be adjustable.

[0036] The tissue penetrator may extend and / or retract from the elongate body and / or the tissue-contacting member. For example, the tissue penetrator may be flush or recessed within the elongate body and / or tissue-contacting member until it is deployed to advance distally into and penetrate through the tissue. The tissue penetrator may be configured to advance a fixed or adjustable distance through the tissue, such as between about 1mm and about 20 mm (e.g., between 1mm and 15 mm, between about 1 mm and 10 mm, etc.). The tissue penetrator may be configured to be advanced until it penetrates through the target tissue once the tissuecontacting member is held against the target tissue. The tissue penetrator may be locked into position once extended distally the fixed or adjustable amount. For example, the tissue penetrator may be a needle that extends through the elongate body. In some embodiments the needle may extend through at least a portion of the tissue-contacting member.

[0037] The electrode positioning member may be bent or biased so that it assumes and / or maintains a bent configuration once extended through the tissue penetrator. In some cases the electrode positioning member may be a shape-set material forming or supporting one or more electrodes. The electrode positioning member may be held in a linear configuration within the tissue penetrator but may maintain a bent and / or curved shape once extended distally from - 9 - SG Docket No.: 14567-736.600 / 133 PCTthe tissue penetrator. In some cases the electrode positioning member may comprise a shapememory material, such as an alloy of nickel -titanium. The electrode positioning member may assume a linear shape, a circular or oval shape, etc. in the deployed configuration (e.g., extending from the tissue penetrator). In some cases the electrode positioning member may form a loop.

[0038] The electrode positioning member may include one or more electrodes. The electrode(s) may be one single electrode or multiple separate electrodes, electrode(s) may have different shapes, including elongate shape. The position and / or size of the one or more electrodes on the electrode positioning member may be configured to match the electrode(s) on the tissue-contacting member. In some cases the electrode positioning member is an electrode; for example, the electrode positioning member may be a wire, e.g., a Nitinol wire, which is insulated along much of its length, with an exposed, un-insulated region forming the electrode portion.

[0039] In some cases the electrode positioning member may be deflected as it is extended distally out of the tissue penetrator and through the tissue. In some cases the tissue penetrator may include a deflector at the distal end region that is configured to deflect the electrode positioning member at an angle relative to the long axis of the tissue penetrator, which may be approximately the same as the long axis of the elongate member. This angle of deflection may be approximately the same as the angle between the elongate member and the tissuecontacting member. The deflector may be configured to deflect the electrode positioning member so that it is approximately parallel to the tissue-contacting member. In some cases the deflector may be part of the elongate body, such as at a distal end opening out of the elongate body and may include a ramp or projection forming a deflection surface. The deflection surface may be angled or curved relative to the long axis of the elongate shaft. The deflector may be deployed from a non-deflecting configuration to a deflecting configuration. For example, the deflector may include a deflection surface that is moved into the path of the electrode positioning member before or after it exits the elongate member. The deflector may be configured to pivot or otherwise move the deflection surface into the path of the electrode positioning member so as to redirect the electrode positioning member into a path that extends substantially parallel to the tissue-contacting member. In some cases the deflector may be biased (e.g., spring-driven) to move into the path of the electrode positioning member.

[0040] In some cases the deflector may be a separate component. For example, the deflector may be an inner or outer member (e.g., cannula) that is configured to form a curve as it extends distally from the tissue penetrator, or to otherwise provide a deflection surface - 10 - SG Docket No.: 14567-736.600 / 133 PCTagainst which the electrode positioning member maybe be deflected so as to extend approximately in parallel to the tissue-contacting member. In some cases the apparatus does not include a deflector. For example, the electrode positioning member may be configured to extend distally out of the elongate body and / or tissue-contacting member, and once sufficiently extended, may itself assume a shape-set configuration which may be approximately parallel to the tissue-contacting member (and any electrodes thereon).

[0041] In any of these apparatuses the electrode positioning member and / or the tissuecontacting member may be adjustable to compress the tissue between the two, so that the tissue may be maintained in contact with the electrode(s) on the tissue-contacting member and on the electrode positioning member. For example, an end region of the elongate shaft may be configured as a handle and / or may include one or more controls, such as a tissue penetrator deployment and / or retraction control, an electrode positioning member deployment and / or retraction control, a clamping control (e.g., to adjust the spacing between the tissuecontacting member and the electrode positioning member), etc.

[0042] The elongate body may be any appropriate length. For example, the elongate body may extend between 4 inches and 48 inches or more (e.g., between 5 inches and 36 inches, between 5 inches and 24 inches, etc.). As mentioned, the elongate body may include a handle on the proximal end of the elongate body. The handle may be configured to be gripped, or it may be configured for attachment to a movable arm of a robotic system.

[0043] Any of these apparatuses may be configured to be used with a power supply configured to provide very short pulses (e.g., microsecond, sub-microsecond, such as nanosecond, picosecond, etc.). For example, these methods and apparatuses may be preferentially used to apply high voltage, very short electrical pulses, such as microsecond or sub-microsecond (e.g., nanosecond) pulses, to treat patients. For example, applying the pulsed electrical energy (between the electrodes of the electrode positioning member and the tissue-contacting member) may comprise applying a plurality of electrical pulses having an amplitude of greater than 0.1 kV. For example, the electrical pulses may have an amplitude of at least 0.5 kV and a duration of less than 50 microseconds, or less than 1000 nanoseconds, or less than 300 nanoseconds therebetween. For example, an apparatus as described herein may be configured to pass electrical pulses having an amplitude of about 1 kV or greater, about 2 kV or greater, about 3 kV or greater, about 5 kV or greater, about 6 kV or greater, about 7 kV or greater, about 8 kV or greater, about 9 kV or greater, about 10 KV or greater, between about 0.1 kV and 100 kV, between about 1 kV and about 50 kV, between about 3 kV and about 100 kV, between about 5 kV and about 100 kV, etc. The pulses may be submicrosecond pulses (e.g., less than about 1000 ns, e.g., between about 1 ns and about 1000- 11 - SG Docket No.: 14567-736.600 / 133 PCTns, between about 1 ns and about 950 ns, between about 1 ns and about 900 ns, between about 5 ns an about 1000 ns, between about 5 ns and about 950 ns, between about 5 ns and about 900 ns, etc.), microsecond pulses or less (e.g., 1000 ps or less, 900 ps or less, 800 ps or less, 700 ps or less, 600 ps or less, 500 ps or less, 400 ps or less, 300 ps or less, 200 ps or less, 100 ps or less, 50 ps or less, 10 ps or less, 1 ps or less, between about 1 ns and about 1000 ps, between about 1 ns and about 950 ps, between about 1 ns and about 900 ps, between about 5 ns an about 1000 ps, between about 5 ns and about 950 ps, between about 5 ns and about 900 ps, etc.).

[0044] For example, the methods and apparatuses of the present disclosure may be used with any appropriate pulse generator, including sub-microsecond pulse generators (e.g., nanosecond pulse generators), such as those as described in U.S. Patent Publication No. US2017 / 0245928, published August 31, 2017, entitled “HIGH-VOLTAGE ANALOG CIRCUIT PULSER WITH FEEDBACK CONTROL”, U.S. Patent Publication No.US2022 / 0023631, published January 27, 2022, entitled “NANOSECOND PULSED ELECTRIC FIELD SYSTEM”, all incorporated herein by reference. The apparatuses described herein may be part of and / or configured for use with such pulse generators. For example, a system may include a pulse generator (e.g., a microsecond or sub-microsecond pulse generator) and the applicators (e.g., clamp-type applicators) described herein. A system may include any of the applicators described herein and a pulse generator configured to produce electrical pulses having a duration in microsecond range, or in some implementations in nanosecond or sub-nanosecond ranges, for example. The pulse generator may be controlled manually, automatically or semi-automatically. For example, a human operator may input a number of pulses, amplitude, pulse duration, and frequency information, for example, into a numeric keypad or a touch screen of interface. The interface may provide information regarding the treatment to the operator including providing configuration information for the user to view and adjust as well as treatment values and information during the administration of the treatment. In some embodiments, the pulse width can be varied. Examples

[0045] FIGS. 1 A-1E illustrate one example of a clamp-type applicator as described herein. Clamp-type applicator as used herein means treatment applicator of any configuration that allows a treatment area (e.g., target tissue) to be positioned between two portions of the applicator. At least one of the two portions of the applicator may comprise one or more electrodes. FIG.1A shows an apparatus 100 in a fully deployed configuration, including an elongate shaft 101 and a tissue-contacting member 103 that extends at an angle from the- 12 - SG Docket No.: 14567-736.600 / 133 PCTdistal end of the elongate shaft. In this example the angle is fixed; in other examples this angle may be adjustable. In this example, an electrode positioning member 105 is shown extending from the distal end of the elongate shaft 101. The electrode positioning member 105 is shown as wire (e.g., a Nitinol wire) forming a single electrode. An optional electrically insulating sleeve 109 may be covering the more proximal end of the electrode positioning member 105. There is a gap or space 112 between the tissue contacting member 103 and the electrode positioning member 105. The tissue may fit into this gap and this gap may be adjustable, e.g., by adjusting a clamp control on the proximal handle region (not shown). In this example, the insulating sleeve 109 may also be configured as a guide that directs the electrode positioning member 105 to assume a bend and extend parallel to the tissuecontacting member 103, as shown in FIG. 1 A.

[0046] FIGS. 1B-1E illustrate deployment of the apparatus shown in FIG. 1 A. In FIG. IB, the bottom of the elongate shaft 101 is shown, as well as a portion of the tissuecontacting surface of the tissue-contacting member 103. There is an opening 106 into a lumen of the elongate body 101 through which the electrode positioning member 105 may extend into and / or out of. FIG. 1C shows the same perspective as FIG. IB, but with a tissue penetrator 107 extending distally out of the elongate body 101, and an electrode positioning member 105 extending through the tissue penetrator 107. The tissue penetrator in this example is a needle.

[0047] In some examples the apparatus may include a deflector (not shown in FIGS. 1 A-1C) that may extend into the path of the electrode positioning member 105 so as to redirect the electrode positioning member 105 so that it extends in a path that is substantially parallel to the tissue-contacting member 103. For example, a deflector may comprise a ramp or other projection having a deflection surface that extends (or can be deployed either automatically or manually) to extend at least partially across the opening 106 into the elongate body, or across a channel or tube projecting from the elongate body through which the electrode positioning member 105 passes.

[0048] FIG. ID shows another view in which the tissue penetrator has been removed (e.g., proximally back into the elongate body), leaving a distal portion of the electrode positioning member 105 and a portion of the electrically insulating sleeve 109 extending distally from the elongate body 101. The electrode positioning member 105 may be configured (e.g., shape set) to assume the bent configuration once a sufficient portion of it has extended distally from the elongate body, as shown in FIG. IE. The electrode positioning member 105 and the insulating portion 109 may be moved independently of each other (e.g., axially), so that, as shown in FIG. IE, the wire electrode formed by the electrode positioning - 13 - SG Docket No.: 14567-736.600 / 133 PCTmember be exposed (un-insulated) over much of its length, but may remain insulated from the more proximal region, because it is within the insulating sleeve. In some examples, as discussed above, the sleeve 109 may be configured as a guide that may be configured (e.g., biased) to deflect and bend to direct the electrode positioning member to extend substantially parallel to the tissue-contacting member 103 instead of or in addition to the electrode positioning member being biased to bend and deflect.

[0049] FIGS. 2A-2E show another example of a clamp-type applicator apparatus, in which the tissue-contracting member is configured as a flattened disk and the electrodepositioning member comprises two loops that extend in an oval or circle. FIG. 2A shows the distal end of the device 200 in a fully deployed configuration. In this example, the apparatus includes an elongate shaft 201 and a disk-shaped tissue-contacting member 203 that extends radially around the distal end region of the elongate shaft 201 at a fixed angle. The distal end of the elongate shaft 201 in this example passes through the center region of the tissuecontacting member. In this example, an electrode positioning member 205 extends as a pair of loops of wire (e.g., Nitinol wire) that are arranged to extend in parallel to the tissuecontacting member holding one or more electrodes (not visible in FIGS. 2A-2E). The electrode positioning member may form a single electrode or it may include insulated and non-insulated regions forming multiple different electrodes. FIGS. 2B-2E illustrate deployment of the electrode positioning member 205. For example, FIG. 2B shows the tissuecontacting member 203 prior to deployment, including an opening 206 into the lumen of the elongate body 201, out of which the tissue penetrator 207, shown in FIG. 2C, may extend. Once the tissue-contacting surface of the tissue-contacting member is positioned against the tissue, the tissue penetrator may extend distally through the wall of tissue until it opens into the opposite side of the wall. In FIG. 2D, the electrode positioning member 205 may then be extended distally out of the tissue penetrator (and, for example, through the insulating sleeve 209). In this example the electrode positioning member 205 includes two loops that are extended out until they assume their pre-set shape, each a semicircular loop that is oriented approximately parallel to the tissue-contacting surface of the tissue-contacting member 203, which will be on the opposite side of the tissue wall from each other. As shown in FIG. 2E the electrode positioning member 205 may be retracted proximally to clamp onto the tissue and ensure electrical contact between electrode(s) of the tissue-contacting member and the electrode(s) formed by the electrode positioning member. The electrically insulating sleeve 209 covers the more proximal portion including the portion within the lumen of the elongate body. As described in reference to FIGS. 1 A-1E, in some examples the sleeve may be a guide that is configured to deflect the electrode positioning member 205 as it is deployed and- 14 - SG Docket No.: 14567-736.600 / 133 PCTextends distally. In some cases the sleeve may include one or more deflection surfaces (e.g., projections) configured to deflect the electrode positioning member 205. Alternatively or additionally, the electrode positioning member 205 may be biased (e.g., pre-formed) to assume a path or shape that is substantially parallel to the tissue-contacting member 203 when deployed.

[0050] FIGS. 3 and 4 each also illustrate different variations of apparatuses described herein. In FIG. 3, the apparatus includes an elongate shaft 301 and a tissue-contacting member 303. In this example the tissue-contacting member 303 may be configured to move axial (proximal to distal) relative to the elongate shaft, and may also include an insulating sleeve 312 that may move within, similar to some embodiments of the electrode positioning member 305. The sectional view in FIG. 3 also shows the tissue penetrator 307 extending within the elongate shaft 301 and penetrating through the tissue, for example, an outer epicardium 313 surface and an inner endocardium 314 surface. The electrode positioning member 305 may also assume a bend relative to the long axis of the elongate shaft 301 so that once bent it may extend substantially parallel to the tissue-contacting member 303 to align electrodes on either side of the tissue on the tissue-contacting member 303 and electrode positioning member 305, respectively. In some cases the tissue-contacting member may, similar to the electrode positioning member, be formed of a wire, such as a shape memory alloy (conductive) material.

[0051] FIG. 4 shows another example that includes a tissue-contacting member 403 extending laterally from the elongate shaft 401, as shown. A lumen through the elongate shaft may include a tissue penetrator 407 (e.g., needle) configured to extend through the tissue (between epicardium 413 and endocardium 414 in this example) wall so that the electrode positioning member 405 may be positioned on the other side of the tissue wall in parallel or approximately parallel with the tissue-contacting member 403. Once deployed, the device may clamp 420 on to the tissue in any of these examples, e.g., by pulling the deployed electrode positioning member 405 proximally, as shown by arrow 420. The clamping action indicated by arrow 420 in FIG. 4 may be implemented in any examples and embodiments according to the present disclosure.

[0052] FIG. 5 illustrates one example of a method of treating tissue using an apparatus such as any of the examples discussed above. For example, the method may include positioning a tissue-contacting member of the apparatus against a first side of the tissue to be treated, e.g., such as, but not limited to, an endocardium (step 501). The tissue-contacting member may comprise one or more electrodes. A tissue penetrator (e.g., needle) may be extended distally from the elongate body of the apparatus and into and through the tissue to - 15 - SG Docket No.: 14567-736.600 / 133 PCTan opposite side from the first side (step 503). Once the opposite side of the tissue to be treated (e.g., a wall of a target tissue or organ) has been reached, an electrode positioning member, including and / or forming one or more electrodes, may be extended distally out of the tissue penetrator (step 505). The electrode positioning member may be extended such that it assumes a direction along the opposite side of the tissue. The tissue-penetrating member may be withdrawn proximally. Once positioned along the opposite side of the tissue, the electrode positioning member and tissue-contacting member may be clamped to the tissue, e.g., by pulling proximally the electrode positioning member to make good contact with both sides of the tissue.

[0053] Finally, energy may be applied between the electrode(s) of the tissue-contacting member and the electrode(s) of the electrode positioning member (step 507), to treat the tissue. The treatment may be monitored directly or through one or more recording devices.

[0054] FIGS. 6A-6B illustrate another example of an apparatus similar to those described above, in which the tissue-contacting member 603 is configured as an expandable (and at least partially inverting) basket. In this example, the device 600 includes an elongate body 601 that extends distally from a proximal handle (not shown). FIG. 6A shows a tissue contacting member 603 in a partially extended configuration. In this example, a proximal end 603a of the tissue contacting member may be coupled to the elongated body 601 and the distal end 603b may be coupled to a deployment member 610 (e.g., tube, rod, shaft, etc.) that is coaxial with, and may be configured to move relative, to the elongate body 601. The tissuecontacting member 603 may be deployed, for example, by pulling the deployment member 610 with the attached distal end 603b proximally. In some implementations, it may be deployed by pushing the elongate body 601 with the attached proximal end 603 a of the tissue-contacting member distally. In some examples the tissue-contacting member 603 may be deployed by both pushing the elongate body 601 with the attached proximal end 603a of the tissue-contacting member distally and pulling the deployment member 610 with the attached distal end 603b proximally. Alternatively or additionally, in some examples the tissue-contacting member 603 may be biased to expand outwards, and may be held in a collapsed configuration by a tubular cover (not shown in FIGS. 6A-6B) that may be driven proximally off of the tissue-contacting member 603 to allow it to expand and deploy and / or may be driven distally back over the tissue-contacting member 603 to collapse it back down. The device 600 is shown with the tissue-contacting member 603 fully deployed (in this example, expanded and inverted) in FIG. 6B. The tissue-contacting member 603 may include one or more electrodes. In some examples the tissue-contacting member 603 is a mesh basket that may form a single electrode or it may be formed of an insulated wire or wires with un- - 16 - SG Docket No.: 14567-736.600 / 133 PCTinsulated regions (e.g., around the perimeter of the basket or the distal-facing side of the basket) forming multiple electrodes. The device 600 shown in FIGS. 6A-6B also includes a distal tissue penetrator 607 extending or extendable from the distal end of the elongate body 601 (and / or deployment member 610) that in some examples may be configured to extend distally from the elongate body and to retract proximally into the elongate body.Alternatively, in any of the apparatuses described herein the tissue penetrator may remain extended during the procedure and / or may not be configured to retract into the elongate body.

[0055] FIG. 6B shows the device 600 with the tissue-contacting member 603 fully deployed, and with an electrode positioning member 605 comprising one or more electrodes extending distally and also fully deployed. As discussed above, the electrode positioning member is configured to extend distally through the tissue penetrator and, upon deployment from the distal end of the tissue penetrator, assume a tissue-contacting shape and / or direction extending adjacent to the tissue-contacting member and separated by a gap configured to hold a tissue therebetween. In FIG. 6B the electrode positioning member 605 extends distally from an elongate body of a shaft of the apparatus as a ring (or in some cases as a partial ring). The electrode positioning member 605 may comprise an electrode or may itself be configured as an electrode.

[0056] In use, the device 600 shown in FIGS. 6A-6B may be inserted into the body, including percutaneously inserted into the body, and the tissue-contacting member 603 may be expanded outwards from the distal end region, and advanced distally, e.g., through the tissue, such as through the epicardium of the heart so that the tissue-contacting member 603 resides against the epicardium while the tissue penetrator penetrates the tissue. For example, the tissue penetrator may penetrate through the tissue to the opposite side (e.g., endocardium). Once on the opposite side of the tissue, the electrode positioning member 605 may be deployed so that it extends substantially along (e.g., approximately parallel or parallel) the endocardium and energy may be applied between the electrodes on the electrode positioning member 605 and the tissue-contacting member 603 to treat the tissue.

[0057] FIGS. 7A-7C illustrate another example of an apparatus 700. In FIG. 7A, the device 700 is shown in the undeployed configuration that has a narrow profile such that a tissue-contacting member 703 and electrode positioning member 705 are both inside the elongate body 701 (for example, positioned in the undeployed configuration side by side or concentrically inside the elongate body 701, for example, within the same or different lumens of the elongate body). The elongate body 701 has a distal end region from which a tissuecontacting member 703 extends or may extend. In FIG. 7B, the tissue-contacting member 703 is shown as a plurality of petals or loops, forming a floral configuration, which may be, e.g.,- 17 - SG Docket No.: 14567-736.600 / 133 PCTformed of wire that extends radially outward from the elongate body. The tissue-contacting member 703 may be pushed out from the distal end of the elongate body 701 and expand. In some implementations the tissue-contacting member 703 (or members) may be held in a collapsed or undeployed delivery configuration, for example, by using a cover, such as a tubular cover, (not shown in FIGS. 7A-7C). Such cover may be pulled, e.g., slid, proximally off of the tissue-contacting member(s) 703 to allow expansion and deployment of the tissuecontacting member(s) 703. The tissue-contacting member(s) 703 may be collapsed back down, e.g., for removal from the body, by driving, e.g., sliding, the cover distally back over the tissue-contacting member(s) 703, to collapse the tissue-contacting member(s) 703 back down.

[0058] The distal end of the device 700 also includes a needle-like tissue penetrator 707 that extends or is configured to extend distally from the elongate body 701. In some examples this tissue penetrator may retract proximally into the elongate body 701; alternatively the tissue penetrator 707 may remain extended distally. As shown in FIG. 7C, the device 700 also includes an electrode positioning member 705 that includes one or more electrodes and is configured to extend distally through the tissue penetrator 707 and, upon deployment from the distal end of the tissue penetrator, assume a tissue-contacting shape that is substantially adjacent to the tissue-contacting member 703 and separated by a gap configured to hold tissue.

[0059] The device shown in FIGS. 7A-7C may be operated similarly to that shown in FIGS. 6A-6B. For example, the device 700 shown in FIGS. 7A-7C may be inserted into the body, including percutaneously inserted into the body, and the tissue-contacting member 703, in a radially-expanded configuration, may advance distally towards the target tissue, while the tissue penetrator penetrates into the tissue to the opposite side of the tissue wall. The tissue-contacting member 703 may be held against the tissue, and the electrode positioning member 705 may be deployed so that it extends in parallel to tissue-contacting member 703 with the tissue held between the two. Alternatively, in any of these examples, the electrode positioning member may be deployed before the tissue-contacting member is moved or held against the tissue. For example, in FIGS. 6A-6C, the tissue-contacting member 603 may be radially expanded after deploying the electrode positioning member 605; similarly, in FIGS.7A-7C, the tissue-contacting member 703 may be radially expanded after deploying the electrode positioning member 705. Furthermore, in some implementations, both tissuecontacting member and electrode positioning member may be expanded simultaneously once they are positioned on the opposite sides of the target tissue. As in any of these examples, the spacing between the electrode positioning member and the tissue-contacting member may be - 18 - SG Docket No.: 14567-736.600 / 133 PCTadjusted to clamp the tissue between the two, and energy may be applied between the electrodes of the tissue-contacting member and the electrode positioning member to treat, e.g., ablate, the tissue.

[0060] FIGS. 8A-8C illustrate another example of an apparatus and method similar to those shown in FIGS. 6A-6B but in this example of the device 800 both the electrode positioning member 805 and the tissue-contacting member 803 are formed as expandable baskets that may be deployed, separately or in some variations, together, to extend radially outwards from the long axis of the elongate member 801. The spacing between the electrode positioning member 805 and the tissue-contacting member 803 may be adjustable to clamp or hold the tissue between them. The device 800 also includes a tissue penetrating member 807 at the distal end, distal to the electrode positioning member 805. For example, in FIG. 8Athe device 800 is shown in a very early stage of the deployment, in which the electrode positioning member 805 and the tissue-contacting member 803 are both beginning to radially partially expand. The expansion of the tissue-contacting member 803 may be in a manner similar to that described in reference to FIGS. 6A-6B.

[0061] As shown in FIG. 8B, the electrode positioning member 805 and the tissuecontacting member 803 are fully radially expanded outwards. For example, the distal end regions of each of the electrode positioning member 805 and the tissue-contacting member 803 may be connected to a deployment member that is coaxial with the elongate body 801 and may be moved proximally or distally to expand and / or contract the electrode positioning member 805 and the tissue-contacting member 803. Alternatively or additionally one or both of the electrode positioning member 805 and the tissue-contacting member 803 may be configured to self-expand. For example, the electrode positioning member 805 may also be inverted when radially expanded, as shown in FIG. 8C, and the tissue-contacting member 803 may be inverted when radially expanded, also as shown in FIG. 8C. Depending on implementations, the tissue-contacting member 803 and the electrode positioning member 805 may be expanded sequentially or simultaneously.

[0062] Thus, in FIGS. 8A-8C both the tissue-contacting member 803 and the electrode positioning member 805 are formed of a mesh. In some cases the tissue-contacting member 803 and the electrode positioning member 805 may be connected to one or more elongate deployment member (e.g., rod, tube, needle, etc.) that may extend within the elongate body. This one or more elongate deployment member can be pulled proximally or pushed distally to change the radial expansion of the tissue-contacting member 803 and the electrode positioning member 805 and, therefore, the spacing between the two, allowing this configuration to adjust the spacing between the tissue-contacting member 803 and the- 19 - SG Docket No.: 14567-736.600 / 133 PCTelectrode positioning member 805 as needed (e.g., to fit different tissue therebetween). This ability to change the size and configuration of the tissue-contacting member and the electrode positioning member may also be used to adjust / control the size of the resulting ablation zone when applying energy between the electrodes of the tissue-contacting member 803 and the electrode positioning member 805.

[0063] 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 foregoing concepts and additional concepts discussed in greater detail below (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.

[0064] 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.

[0065] While various embodiments have been described and / or illustrated herein in the context of fully functional computing systems, one or more of these example embodiments may 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.

[0066] 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- 20 - SG Docket No.: 14567-736.600 / 133 PCTdescribed herein. In their most basic configuration, these computing device(s) may each comprise at least one memory device and at least one physical processor.

[0067] 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.

[0068] 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.

[0069] 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.

[0070] 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.

[0071] 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 - 21 - SG Docket No.: 14567-736.600 / 133 PCTmagnetic-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.

[0072] 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.

[0073] 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.

[0074] 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.

[0075] 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 / or elements 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.

[0076] 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,- 22 - SG Docket No.: 14567-736.600 / 133 PCTsteps, 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 " / ".

[0077] 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.

[0078] 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 one feature / 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.

[0079] 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.

[0080] 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", “substantially” or “approximately,” even if the term does not expressly appear. The phrase “about”, “substantially” 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 - 23 - SG Docket No.: 14567-736.600 / 133 PCTvalues), + / - 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 the 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.

[0081] 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 system embodiments 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.

[0082] 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.- 24 - SG Docket No.: 14567-736.600 / 133 PCT

Claims

CLAIMSWhat is claimed is:

1. An apparatus comprising:an elongate body;a tissue-contacting member extending or configured to extend outward at an angle from a distal end region of the elongate body, the tissue-contacting member comprising one or more electrodes;a tissue penetrator configured to extend distally from the elongate body and to retract proximally into the elongate body; andan electrode positioning member comprising one or more electrodes, the electrode positioning member is configured to extend distally through the tissue penetrator and, upon deployment from the distal end of the tissue penetrator, assume a tissue-contacting shape and / or direction extending adjacent to the tissue-contacting member and separated by a gap configured to hold a tissue therebetween.

2. The apparatus of claim 1, wherein the tissue-contacting member extends or is configured to extend perpendicularly from the distal end region of the elongate body.

3. The apparatus of claims 1 or 2, wherein the tissue-contacting member comprises a linear arm.

4. The apparatus of claims 1 or 2, wherein the tissue-contacting member comprises a plurality of petals.

5. The apparatus of claims 1 or 2, wherein the tissue-contacting member comprises a disk.

6. The apparatus of claims 1 or 2, wherein the tissue-contacting member comprises an expandable basket or a mesh.

7. The apparatus of any of claims 1- 6, wherein the tissue-contacting member comprises an expandable funnel.

8. The apparatus of any of claims 1-7, wherein the electrode positioning member comprises a wire forming the one or more electrodes.- 25 - SG Docket No.: 14567-736.600 / 133 PCT9. The apparatus of any of claims 1-8, wherein the electrode positioning member comprises an expandable basket or a mesh.

10. The apparatus of any of claims 1-9, wherein the electrode positioning member comprises one or more loops.

11. The apparatus of any of claims 1-10, wherein the electrode positioning member comprises a nickel -titanium alloy.

12. The apparatus of any of claims 1-10, wherein the electrode positioning member comprises an electrically conductive wire forming a single electrode.

13. The apparatus of any of claims 1-7, further comprising a guide or a deflecting surface configured to deflect the tissue penetrator and / or the electrode positioning member at an angle relative to the long axis of the elongate body.

14. The apparatus of any of claims 1-7, further comprising an electrically insulating sleeve through which the electrode positioning member may extend, wherein the electrically insulating sleeve is configured to extend distally from the elongate body and to retract proximally into the elongate body.

15. The apparatus of any of claims 1-14, further comprising a clamp control configured to adjust a separation between the electrode positioning member and the tissuecontacting member.

16. The apparatus of any of claims 1-15, wherein the apparatus is configured as a clamptype structure for delivering energy across a wall of an organ.

17. An apparatus comprising:an elongate body;a tissue-contacting member extending or configured to extend laterally outward from a distal end of the elongate body wherein the tissue-contacting member comprises an arm having one or more electrodes on the tissue contacting surface of the arm;a tissue penetrator configured to extend distally from the elongate body and to retract proximally into the elongate body;an electrically conductive wire forming one or more electrodes configured to extend distally through the tissue penetrator, wherein the electrically- 26 - SG Docket No.: 14567-736.600 / 133 PCTconductive wire is configured to assume a tissue-contacting shape upon deployment from a distal end of the tissue penetrator so that the electrically conductive wire extends laterally adjacent to and separated from the tissuecontacting member by a gap configured to hold a tissue therebetween; and an electrically insulating sleeve through which the electrically conductive wire extends distally and proximally,wherein the tissue penetrator, electrically conductive wire and the electrically insulating sleeve are all slide laterally relative to each other into and / or out of the distal end of the elongate body.

18. The apparatus of claim 17, wherein the tissue-contacting member extends or is configured to extend perpendicularly from the distal end region of the elongate body.

19. The apparatus of claims 17 or 18, wherein the electrically conductive wire comprises a nickel -titanium alloy wire forming the one or more electrodes.

20. The apparatus of any of claims 17-19, wherein the electrically conductive wire comprises one or more loops.

21. The apparatus of any of claims 17-20, wherein the electrically conductive wire forms a single electrode.

22. The apparatus of any of claims 17-21, wherein the electrically conductive wire is configured to expand into a basket or mesh configuration upon deployment from the distal end of the tissue penetrator so that the one or more electrodes of the electrically conductive wire are positioned on an opposite side of a tissue wall from the one or more electrodes of the tissue-contacting member.

23. The apparatus of any of claims 17-22, further comprising a clamp control configured to adjust a separation between the distally-extended electrically conductive wire and the tissue-contacting member.

24. An apparatus comprising:an elongate body;a tissue-contacting member extending or configured to extend laterally outward from a distal end region of the elongate body and contact a first side of a target tissue, wherein the tissue-contacting member comprises one or more electrodes;- 27 - SG Docket No.: 14567-736.600 / 133 PCTa tissue penetrator configured to extend distally from the elongate body and the tissue-contacting member, and to retract proximally into the elongate body; andan electrode positioning member comprising one or more electrodes, the electrode positioning member is configured to extend distally through the tissue penetrator out to a side of the target tissue that is opposite to the first side and assume a direction along the opposite side of the target tissue.

25. The apparatus of claim 24, wherein the tissue-contacting member extends or is configured to extend perpendicularly from the distal end region of the elongate body.

26. The apparatus of claims 24 or 25, wherein the electrode positioning member comprises an electrically conductive wire forming the one or more electrodes.

27. The apparatus of claim 26, wherein the electrically conductive wire forms a single electrode.

28. The apparatus of any of claims 24-26, wherein the electrode positioning member is configured to assume the direction substantially parallel to the tissue-contacting member.

29. The apparatus of any of claims 24-28, further comprising a clamp control configured to adjust a separation between the distally-extended electrode positioning member and the tissue-contacting member.

30. A method, the method comprising:positioning a tissue-contacting member of an apparatus against a first side of a tissue to be treated, the tissue-contacting member comprising first one or more electrodes;extending a tissue penetrator from an elongate body of the apparatus through the tissue to a side of the tissue opposite to the first side;passing or extending an electrode positioning member comprising second one or more electrodes through the tissue penetrator so that it extends from a distal end of the tissue penetrator and assumes a shape and / or direction along the opposite side of the tissue; and applying energy between the first one or more electrodes on the first side of the tissue and the second one or more electrodes on the opposite side of the tissue.- 28 - SG Docket No.: 14567-736.600 / 133 PCT31. The method of claim 30, further comprising expanding the electrode positioning member as it is extended from the tissue penetrator, wherein expanding comprises expanding to form one of: a basket, a funnel or a loop.

32. The method of claims 30 or 31, further comprising: clamping the tissue between the tissue-contacting member and the electrode positioning member.

33. The method of claim 30, wherein extending the electrode positioning member through the tissue penetrator comprises extending an insulative tube out of the tissue penetrator and at least partially around the electrode positioning member.

34. The method of any of claims 30-32, further comprising retracting the tissue penetrator into the elongate member after extending the electrode positioning member through the tissue penetrator.

35. The method of any of claims 30-34, further comprising applying microsecond or sub- microsecond pulses between the first one or more electrodes and the second one or more electrodes.- 29 - SG Docket No.: 14567-736.600 / 133 PCT

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