Braided electrodes or woven electrodes

Abstract

To provide electrical applicator devices having a funnel-shaped portion with one or more electrodes on a distally facing end region of the funnel shape.SOLUTION: The devices may be deployable by inverting a braided or woven body back into itself to form the funnel. These devices may be used to perform a medical procedure, such as an ablation procedure.SELECTED DRAWING: Figure 14

Description

Technical Field

[0001] (Cross - Reference to Related Applications) This patent application claims priority to U.S. Provisional Patent Application No. 63 / 117,433, filed on November 23, 2020, entitled "BRAIDED OR WOVEN ELECTRODES", which is hereby incorporated by reference in its entirety.

[0002] (Incorporation by Reference) All publications and patent applications cited herein are hereby incorporated by reference in their entirety, as if each individual publication or patent application was specifically and individually indicated to be incorporated by reference.

[0003] (Field of the Invention) This specification describes medical devices (e.g., devices, systems, etc.) and methods that can be used to perform medical procedures for treating patients. Specifically, this specification describes an electrical applicator having one or more funnel - shaped electrodes that may also include a central electrode.

Background Art

[0004] Short, high - field - strength electrical pulses are described for the electro - manipulation of biological cells. For example, the electrical pulses can be used for the treatment of animal (including human) tissues such as tumors, including but not limited to basal cell carcinoma, squamous cell carcinoma, and melanoma. Various different applicators for the treatment of tissue, such as electrodes, including needle electrodes and plate electrodes, are described.

[0005] It would be particularly advantageous to be able to treat a patient's tissue, including larger tissue areas, using electrodes that can be manipulated in the body (e.g., minimally or non-invasively) or invasively, including treating a larger surface area. However, due to the high therapeutic voltage and very fast pulse duration, applicators for delivering such pulsed nanosecond energy devices must be configured to avoid damaging tissue or otherwise harming the patient. When high-voltage devices are intended to be inserted into the body, the risks of delivering high-voltage energy (such as electric shock, arc discharge, burns, internal organ damage, and cardiac arrhythmias) are even more serious.

[0006] Therefore, it would be beneficial to provide devices such as applicators (electrode devices, electrical applicators, etc.) that include elongated, flexible applicators capable of applying high-voltage, sub-microsecond electrical pulses to treat patients while mitigating the aforementioned risks. [Overview of the project]

[0007] This specification describes apparatuses and devices (including instruments and devices such as elongated applicator tools configured as, for example, applicator catheters, applicator scopes, tubes, etc.) and methods for treating patients using them, which can more effectively apply therapeutic energy, including but not limited to short, high-field-intensity electrical pulses, while minimizing or avoiding the risk of damaging non-target tissue. In some examples, these apparatuses may be used in blood vessels (e.g., blood vessels) or other body cavities. These applicators may be referred to herein as electrode devices or electrical applicators and may be used for minimally invasive procedures and may be particularly suitable for the treatment of various conditions, disorders, and diseases, for example, cancer (and other types of abnormal tissue growth), but not limited to these. These applications may also be particularly suitable for use with a variety of fully automated and partially automated systems, such as robotic systems. Specifically, the apparatuses described herein may be configured as devices (e.g., catheter devices, catheter applicator tips, endoscopes, laparoscopes, etc.) that can be used with a variety of different generator systems, as will be described in more detail herein.

[0008] In general, according to one embodiment, the electrical applicator described herein includes a braided or woven body that forms one or more funnel shapes, having conductive regions, e.g., distal ends (e.g., openings of the funnel) including electrodes. These funnel-shaped electrodes may include a second conductive region (e.g., an electrode) that may be surrounded by the distal edge on the outside of the funnel. In any of these examples, the second conductive region may be in the same plane as the conductive region on the distal end region of the funnel. In some examples, the second conductive region, which may be centrally positioned relative to the funnel shape, may be coupled to an elongated member that allows the relative longitudinal position of the electrode to be adjusted relative to the distal end region of the funnel.

[0009] In some examples, the electrical applicator includes a second (or more) funnel-shaped electrode concentrically within the outer funnel shape.

[0010] Any of these devices may be configured such that the distal end, which includes a funnel shape and a second (e.g., central) electrode, is controllable from the proximal end of the device. For example, the devices described herein may include a bending region proximal to the braid or woven body, which can be bent controllably by one or more wires or tendons.

[0011] Any of these devices may be configured to form a funnel shape before deployment (e.g., inside the body or immediately before delivery to the body). Before deployment, the woven or braided material forming the funnel shape may be a tube of material that can be formed at least partially from a conductive material. The region of the woven or braided material forming the distal end region of the funnel may not be insulated, while other regions may be insulated (e.g., regions proximal and / or distal to the distal opening of the funnel).

[0012] The funnel shape can be formed, for example, by connecting an internal unfolding member (e.g., a puller, cannula, etc.) to a distal attachment point on a woven or braided material, which may be referred to herein as a braided or woven body, initially formed as a tubular body. The elongated unfolding member can pass through the internal lumen of the braided or woven body. The proximal end of the braided or woven body may be connected to another elongated member, such as a wire, cannula, or tube, or to another part of the device. Alternatively or additionally, the braided or woven material may be held within an outer cannula. The braided or woven body of the device can be unfolded into a funnel shape by pulling and / or pushing the unfolding member. For example, the braided or woven material can be unfolded by pulling an unfolding member proximal to it and / or by driving a member coupled to the proximal end of the braided or woven material, so that the braided or woven material bends radially and inverts into itself (e.g., into the lumen of the tube of the braided or woven material) to form a flared funnel shape. The distal end (large end) of the funnel may be configured to form electrodes, for example, so that all or part of this distal end region is electrically exposed. In some examples, the entire circumference of the distal end region is exposed, and an outer electrode is formed at or near the distal end. In some examples, multiple exposed (e.g., non-insulated) regions may be positioned around the funnel shape. Each non-insulated region may form a separate electrode, each of which may be insulated (and separated) from one another. These electrodes may be individually addressable (e.g., coupled to electrical contacts at the proximal end of the device), or they may be electrically coupled together. If the device includes multiple individually addressable electrodes, these electrodes may be insulated from one another.

[0013] For example, the electrical applicator described herein includes: a braided or woven body having a distal end and a proximal end; an inner unfolding member extending within the braided or woven body and coupled to a distal attachment portion of the braided or woven body, configured to be movable to invert the distal end region of the braided or woven body to form a funnel shape having a distally oriented outer region; a first conductive region at least partially formed around the distally oriented outer region; and a second conductive region configured to be surrounded by the distally oriented outer region and located within the funnel shape when the inner unfolding member is retracted proximal.

[0014] Any of these devices may include an elongated proximal body extending proximal to a funnel shape. This elongated body may be flexible or rigid, or it may be flexible over a portion of its length (e.g., near the distal end) and rigid over another portion of its length (e.g., near the proximal end). The elongated body may include, enclose, and / or house one or more conductors that electrically connect conductive contacts (electrodes) in the distal end region of the device to one or more electrical contacts in the proximal end region. These proximal electrical contacts may be configured to be coupled to a pulse generator for applying electrical energy from the device. Specifically, these electrical contacts at the proximal end may be configured to be coupled to a pulse generator configured to generate a plurality of electrical pulses having an amplitude of at least 0.1 kV and a duration of less than 1000 nanoseconds. Thus, any of these devices may include a pair of electrical connectors in the proximal end region of the elongated proximal body that are in electrical communication with a first conductive region and a second conductive region.

[0015] The devices described herein may include a braid or woven body formed at least partially from conductive wires. The conductive wires may be, for example, stainless steel or a shape memory material (e.g., a shape memory alloy such as a nickel-titanium alloy). Individual wires may be insulated as described above. The first conductive region may be formed from the uninsulated portion of the conductive wires forming the braid or woven body. In some modifications, when the funnel shape is unfolded, at least a portion of the braid or woven body proximal to the distal outer region is electrically insulated.

[0016] The second conductive region may be positioned distal to the distal attachment portion of the braided or woven fabric. When the device is deployed, this second conductive region may be positioned within (or at least partially within) the distal opening of the funnel to form a funnel shape.

[0017] In some examples, the second conductive region may be configured to expand radially when the inner unfolding member is retracted proximally. For example, the second conductive region may also be formed from a braided or woven material (or a second braided or woven material) which can be pulled proximally to become radially flattened (or expand) and form a large contact for the second conductive region.

[0018] Generally, these devices may be configured as bipolar and / or unipolar devices and may operate as either a bipolar electrical applicator or a unipolar electrical device.

[0019] The device according to claim 1, further comprising a positioning member that extends proximal to the second conductive region within the braided or woven body and is configured to allow adjustment of the longitudinal position of the second conductive region with respect to the distal outer region of a funnel shape.

[0020] As described above, the conductive region on the outer distal end region of the funnel may be configured as a single conductive region (e.g., an electrode), or the conductive region may include additional conductive regions (e.g., a third or more conductive regions) separate from the electrode on the first distal outer region. These separate conductive regions may be electrically insulated from each other.

[0021] Any of these devices may be configured to include an outer member, or to operate in conjunction with an outer member. The device may unfold through an outer member, allowing the user to control the outer diameter of the expanded funnel. For example, a braid or woven material may be slidably positioned within the outer member and configured to extend distally outward from the outer member for the unfolding of the funnel shape. In some examples, this may allow the diameter of the funnel (and thus the first conductive region / electrode) to be adjusted by adjusting how far the funnel unfolds outward from the outer member. For example, the outer diameter of the distally facing outer region may be configured to be adjusted by extending or retracting the braid or woven material relative to the distal end opening of the outer member.

[0022] For example, an electrical applicator may include: an elongated outer member; a braid or woven body extending from or extendable from the elongated outer member; an inner unfolding member coupled to the distal attachment portion of the braid or woven body, configured to retract proximally in order to invert the braid or woven body to form a funnel shape having a distally oriented outer region; a first conductive region at least partially formed around the distally oriented outer region, wherein the region of the braid or woven body proximal to the distally oriented outer region is electrically insulated; a second conductive region configured to be surrounded by the distally oriented outer region and located within the funnel shape when the inner unfolding member is retracted proximally; and one or more electrical connectors at the proximal end of the device that are in electrical communication with the first and second conductive regions.

[0023] Any of the devices described herein may be part of a system. For example, a system may include any of the electrical applicators described herein and a pulse generator configured to generate a plurality of electrical pulses having an amplitude of at least 0.1 kV and a duration of less than 1000 nanoseconds, wherein the electrical applicator is configured to be electrically coupled to the pulse generator.

[0024] This specification also describes devices having two or more funnels (e.g., electrical applicators). For example, an electrical applicator may include a braided or woven body; a first funnel shape formed from a first region of the braided or woven body, having a first distally oriented outer region; a second funnel shape formed from a second region of the braided or woven body, concentrically surrounding the first funnel shape and including a second distally oriented outer region; a first conductive region at least partially formed around the first distally oriented outer region; and a second conductive region at least partially formed around the second distally oriented outer region.

[0025] The first and second funnel shapes may be formed from the same woven or braided material, or from separate woven or braided materials. If separate braided or woven materials are used, these separate materials may be joined together (for example, by connectors such as a neck region). In some examples, the same region of braided or woven material may be used, but different strands (e.g., wires, threads, etc.) forming the braided or woven material may be electrically coupled at the distal end to electrical contacts and conductive regions (e.g., electrodes).

[0026] Any of these devices may include an elongated proximal body that extends proximally from the second funnel shape. For example, the elongated proximal body portion may be a handle and / or a connector (e.g., a high-voltage connector) as described herein. The devices described herein may include one or more (e.g., two or more, three or more, etc.) electrical connectors at the proximal end region of the elongated proximal body that is in electrical communication with the first conductive region and the second conductive region.

[0027] In some examples, the device may include an inner deployment member that extends within a braid or weave and is coupled to the distal end of the braid or weave. The inner deployment member is configured to be retracted proximally to invert the braid or weave into the lumen of the braid or weave to form the first funnel shape, or the first and second funnel shapes. The same inner deployment member or a different inner deployment member may be configured to deploy both the first and second funnel shapes. For example, the inner deployment member may be coupled to an attachment region at the distal end of the braid or weave and may form both the first and second funnel shapes by pulling the inner deployment member proximally relative to the proximal end of the braid or weave (e.g., a tube). In some examples, the device includes (or is configured to operate with) an outer member, and the braid or weave may be slidably positioned within the outer member and configured to extend distally out of the outer member to deploy the first and second funnel shapes

[0028] Any of these examples may include a neck member on the braid or weave configured to form the neck of the first funnel shape. In some examples, a second inner deployment member may extend within the braid or weave and be coupled to the neck member, and the second deployment member is configured to be retracted proximally to invert the braid or weave to form the second funnel shape.

[0029] The first region of the braided or woven body may be continuous with the second region of the braided or woven body. The first conductive region and the second conductive region may be on the same plane or may not be on the same plane.

[0030] As described above, the first conductive region and the second conductive region may be electrically coupled or may be electrically separated.

[0031] Thus, these electrical applicators may include two funnels arranged concentrically and having conductive regions (electrodes) on their respective outer surfaces. For example, an electrical applicator includes a braided or woven body having a distally extending lumen, and an inner deployment member that extends within the braided or woven body and is coupled to the distal end of the braided or woven body. The inner deployment member is configured to be retracted proximally to invert the distal end region of the braided or woven body into the lumen of the braided or woven body to form a first funnel shape having a first distally facing outer region. The second region of the braided or woven body is configured to invert into the lumen of the braided or woven body to form a second funnel shape that concentrically surrounds the first funnel shape and includes a second distally facing outer region. The inner deployment member includes a first conductive region formed at least partially around the first distally facing outer region, a second conductive region formed at least partially around the second distally facing outer region, and a third conductive region distal to the distal end of the braided or woven body, the third conductive region being surrounded by the second distally facing outer region and configured to be within the second funnel shape.

[0032] Any of the devices (and / or systems) described herein may be configured to include (not deployable) pre-formed funnels. Thus, these devices may not necessarily include an inner deployment member as described above. In some examples, these devices may instead include a funnel that is either pre-expanded or folded and held within a catheter and can be extended distally from the catheter and expanded. These devices may optionally include a second conductive region within the funnel shape of the device.

[0033] For example, an electrical applicator may include an elongated outer member; a braided or woven body located within the elongated outer member and configured to extend distally outward from the elongated outer member in order to expand into a funnel shape having a distally oriented outer region; a first conductive region at least partially formed around the distally oriented outer region of the funnel shape; and a second conductive region located within the funnel shape and surrounded by the distally oriented outer region.

[0034] As described above, any of these devices may include an elongated proximal body extending proximally from the funnel shape. In some examples, the device includes a pair of electrical connectors at the proximal end region of the elongated proximal body, which are in electrical communication with a first conductive region and a second conductive region.

[0035] The braided or woven fabric may include conductive wires. The first conductive region may be formed from the uninsulated portion of the conductive wires forming the braided or woven fabric. A portion of the braided or woven fabric proximal to the distal outer region may be electrically insulated.

[0036] In any of these examples, the second conductive region may be configured to extend radially as the braid or fabric expands into a funnel shape. The second conductive region (e.g., an electrode) may be coplanar with the first conductive region (e.g., on the distal end region of the funnel). Any of these devices may include an elongated positioning member that extends proximal to the second conductive region into the braid or fabric and is configured to allow adjustment of the longitudinal position of the second conductive region relative to the distal outer region of the funnel shape.

[0037] Generally, the outer diameter of the distal outer region may be configured to be adjusted by extending or retracting the braid or woven material relative to the distal end opening of the outer member. Furthermore, in any of the examples, the apparatus / device of the present disclosure may have, or may be used with, a centering guide / centering feature configured to improve the positioning and centering of the device in contact with the target tissue.

[0038] For example, the electrical applicator described herein includes a braided or woven body and a first region of the braided or woven body that forms or is configured to form a first funnel shape, the first funnel shape comprising a first region having a first distally oriented outer region and a second region of the braided or woven body that forms or is configured to form a second funnel shape, the second funnel shape comprising a second region having a second distally oriented outer region, a first conductive region at least partially formed around the first distally oriented outer region and a second conductive region at least partially formed around the second distally oriented outer region. The first funnel shape may concentrically surround the second funnel shape, or the second funnel shape may concentrically surround the first funnel shape. Any of these devices may include an elongated proximal body extending proximal to the braided or woven body. Any of these devices may include a pair of electrical connectors at the proximal end region of an elongated proximal body, which are electrically in communication with a first conductive region and a second conductive region.

[0039] In some examples, the device may include an internal unfolding member extending into the braid or fabric and coupled to the distal end of the braid or fabric, the internal unfolding member being configured to retract proximally to invert the braid or fabric to form at least one of a first funnel shape and a second funnel shape, or both of the first and second funnel shapes.

[0040] Any of these devices may include a third conductive region enclosed by a first distally oriented outer region and located within a first funnel shape. The device may apply energy between electrodes on the distal ends of the first, second, or third funnel shapes (e.g., between the first and second, the first and third, or the second and third). The first and second conductive regions may be electrically coupled.

[0041] Any of these devices may include an outer member, the braided or woven fabric being slidably positioned within the outer member and configured to extend distally outward from the outer member to unfold a first funnel shape and a second funnel shape. The device may include a neck member on the braided or woven fabric between a first region of the braided or woven fabric and a second region of the braided or woven fabric.

[0042] A second inner unfolding member may be included and may be configured to retract proximally in order to invert the braided or woven body to form a second funnel shape.

[0043] A first region of the braided or woven fabric may be continuous with a second region of the braided or woven fabric. In some examples, the first and second conductive regions are not coplanar.

[0044] This specification also describes methods for using any of the devices and systems described herein. For example, a method for treating tissue using any of these devices may include positioning an electrical applicator in contact with the target tissue such that a first conductive region on the distally facing outer region of a braided funnel shape or woven funnel shape is in contact with the target tissue, and a second conductive region surrounded by the distally facing outer region of the braided funnel shape or woven funnel shape is in contact with the target tissue, and applying a plurality of electrical pulses having an amplitude of at least 0.1 kV and a duration of less than 1000 nanoseconds to the target tissue from the first and second conductive regions.

[0045] This method may also include deploying the electrical applicator before positioning it, for example, by retracting the inner unfolding member of the electrical applicator proximal to invert the distal end region of the braided or woven body of the electrical applicator to form a funnel shape with a distally facing outer region.

[0046] Furthermore, any of these methods may also include adjusting the longitudinal position of the second conductive region using an elongated positioning member that extends proximal to the second conductive member through a braided or woven fabric. For example, the methods described herein may include unfolding a braided funnel shape or a woven funnel shape so that it emerges from an outer member such as an outer catheter.

[0047] The methods described herein may additionally or alternatively include adjusting the outer diameter of the distal outer region by extending or retracting the braided funnel shape or woven funnel shape so that it protrudes from the outer member.

[0048] Multiple electrical pulses may be applied from an electrical applicator in a unipolar configuration. Alternatively, multiple electrical pulses may be applied from an electrical applicator in a bipolar configuration.

[0049] In any of the methods described herein, applying multiple electrical pulses may include applying multiple electrical pulses as part of a single shot. For example, these methods may include applying a single shot of treatment to a target tissue, wherein multiple electrical pulses are applied to the target tissue circumferentially (e.g., around or in a circle with respect to the target tissue), and removing the electrical applicator from the target tissue after the application of the multiple electrical pulses. In some cases, the electrical applicator may be completely removed from the body or repositioned in contact with another target tissue, for example, to another part of the body. Thus, the apparatus described herein can advantageously apply treatment to a large area of ​​target tissue in a single shot without requiring multiple steps of repositioning and applying treatment to the target tissue.

[0050] These methods may be used to treat targets including one or more of the following: veins, arteries, blood vessels, heart, trachea, pharynx, larynx, bronchi, ureters, urethra, fallopian tubes, cervix, uterus, intestines, pancreas, pancreatic duct, liver and hepatic duct, rectum, esophagus, stomach, nasal cavity, seminal vesicles, bronchi, and vocal cords / vocal folds. In one example, the method may be a method for treating endometriosis, and the tissue may be female reproductive system tissue (e.g., ovaries, fallopian tubes, ligaments supporting the uterus (uterosacral ligaments), posterior cecal sac, i.e., the space between the uterus and the rectum, anterior cecal sac, i.e., the space between the uterus and the bladder, the outer surface of the uterus, the inner lining of the pelvic cavity, and possibly the intestines, rectum, bladder, vagina, cervix, and / or vulva.

[0051] For example, a method for treating tissue may include: retracting the inner unfolding member of an electrical applicator proximal to invert the distal end region of the braid or fabric of the electrical applicator in order to form a funnel shape having a distally oriented outer region; positioning the first conductive region on the distally oriented outer region in contact with the target tissue so that a second conductive region surrounded by the distally oriented outer region within the funnel shape also contacts the target tissue; and applying a plurality of electrical pulses having an amplitude of at least 0.1 kV and a duration of less than 1000 nanoseconds from the first and second conductive regions to the target tissue.

[0052] The devices described herein may be configured for manual or automated (e.g., robot-assisted) control. In some modifications, these devices may be incorporated into a system configured to be mounted on or coupled to a movable (e.g., robotic) arm of a robotic system, such as a robotic medical procedure system or a robotic surgical system. For convenience of description, these may be referred to as robotic systems, but such robotic systems are intended to cover any robotic medical procedure system (including cosmetic applications) and may include robotic systems with guidance. In some modifications, the instruments may be guided and controlled by a robotic system during a surgical or other medical procedure. For example, the devices described herein may be used through one or more operating channels of a robotic system.

[0053] As described above, any of these devices may be configured such that the proximal end of the applicator device is adapted to be coupled to a robotic arm, for example, for computer-controlled operation of the first and second electrodes. Alternatively or additionally, the proximal end of the applicator device may be adapted to be coupled to the handle of a pulse generator, and the pulse generator may similarly be adapted to be connected to a robotic arm.

[0054] The apparatus described herein may generally be configured to safely and reliably deliver pulses such as microseconds, nanoseconds, and picoseconds, and may include electric fields having shorter pulse widths, such as 0.1 nanoseconds (ns) to less than 1,000 nanoseconds, or 1 picosecond, which may be referred to as submicrosecond pulsed electric fields. This pulse energy may have high peak voltages such as 1 to 5 kilovolts / centimeter (kV / cm), 10 kV / cm, 20 kV / cm, 100 kV / cm, or more. Therapy of living cells may use numerous periodic pulses at frequencies ranging from 0.1 Hz to 10,000 Hz, which may induce controlled cell death (e.g., apoptosis) in affected tissues, unwanted tissues, or abnormally proliferating tissues, such as cancerous tumors, precancerous or benign tumors, and other target tissues. Selective treatment of such tumors, lesions, or target tissues with high-voltage, sub-microsecond pulsed energy can induce controlled cell death within tumor cells or target tissue cells without substantially affecting normal cells in the surrounding tissue, due to its non-thermal nature. The subject may be a patient (human or non-human, including animals). The user may operate the apparatus described herein on the subject. The user may be a physician (e.g., doctor, surgeon), medical technician, nurse, or other healthcare provider.

[0055] Therefore, applying high-voltage, high-speed (e.g., microsecond or submicrosecond) electrical pulses may include, for example, applying an electrical pulse train having a pulse width of 0.1 nanoseconds (ns) to 1,000 nanoseconds. Applying high-voltage, high-speed electrical pulses may include, for example, applying a submicrosecond electrical pulse train having a peak voltage of 1 kilovolt / centimeter (kV / cm) to 100 kV / cm. Applying high-voltage, high-speed electrical pulses may include, for example, applying a submicrosecond electrical pulse train with a frequency of 0.1 / second (Hz) to 10,000 Hz.

[0056] Any of these devices can be used in conjunction with a pulse generator. For example, a system for treating tissue described herein may include an elongated applicator tool as described herein (e.g., an elongated body having an articulated distal end region configured to have one or more electrodes extending from it), a connector, e.g., a high-voltage connector adapted to connect the elongated applicator tool to a pulse generator, and a pulse generator having a port configured to generate a plurality of electrical pulses having an amplitude of at least 0.1 kV and a duration of less than 1000 nanoseconds, and configured to connect to the high-voltage connector.

[0057] Generally, any of these devices may be used in conjunction with, or as part of, a system that includes a pulse generator configured to generate multiple electrical pulses having an amplitude of at least 0.1 kV and a duration of less than 1,000 nanoseconds, the pulse generator may be configured to connect to the device by a high-voltage connector.

[0058] The devices described herein may be additionally or alternatively configured to operate with a braid or woven fabric that extends radially outward without inversion to form a funnel shape. The inner unfolding region may extend into the braid or woven fabric, or be coupled to a distal attachment portion of the braid or woven fabric, so that the braid or woven fabric can be radially expanded by retracting the inner unfolding member proximal to it. The inner unfolding member may extend distally to fold the braid or woven fabric (e.g., reduce the radial expansion of the braid or woven fabric). One or more conductive regions (including a central region or one or more peripheral regions) on the outer surface of the braid or woven fabric may be included and may be used to apply energy, including a nanosecond pulsed electric field, as described herein. Any of these devices may further include one or more central conductive regions (electrodes) that may be on the inner unfolding region and may be positioned distal to the conductive regions on the braid or woven fabric, and / or may be positioned within the braid or woven fabric. The central electrode may be used to apply bipolar energy from the outer surface of the braided or woven fabric.

[0059] A device in which a braid or fabric is configured to expand radially without inversion may be used, for example, to apply energy to the side of a body cavity, where the distal end of the device is navigated. The expanded braid or fabric may be driven against the wall of the lumen, conform to the wall, and make good electrical contact. In some examples, a nanosecond pulsed electric field may be applied, as described herein.

[0060] In these examples, the inner unfolding member may be restricted (e.g., by a fastener) to prevent the braid or fabric from inverting. In some modifications, the device may be configured to operate in both configurations: one in which the braid or fabric expands radially but does not invert (e.g., to apply energy to the sides of a body cavity), and another in which the braid or fabric inverts at the distal end to form a funnel shape, as described above. Thus, in some examples, the inner unfolding member may engage with a releasable fastener to prevent the braid or fabric from inverting into the funnel, and the fastener may be released to allow the braid or fabric to invert. [Brief explanation of the drawing]

[0061] Novel features of this disclosure are specifically described in the following claims. A better understanding of the features and advantages of this disclosure will be obtained by referring to the following detailed description, which describes exemplary embodiments in which the principles of this disclosure are utilized, and the accompanying drawings. [Figure 1A] An example of an electrical applicator (e.g., an applicator device) having a funnel-shaped electrode, as described herein, is illustrated. Figure 1A shows a non-expandable electrical applicator woven fabric, which extends distally from an outer member and within a self-expanding tube, with a braided or woven mesh (indicated here as woven mesh) extending slightly from distal to proximal. [Figure 1B] An example of an electrical applicator (e.g., an applicator device) having a funnel-shaped electrode, as described herein, is illustrated. Figure 1B is a side view of an unfolded electrical applicator (Figure 1A) forming a funnel shape with a distally oriented outer region. [Figure 2A] Another example of an electrical applicator with a funnel-shaped electrode is shown. In Figure 2A, the electrode is shown from a perspective view as an unfolded electrical applicator, such as the one shown in Figure 1B. [Figure 2B] Another example of an electrical applicator with a funnel-shaped electrode is shown. Figure 2B shows the applicator device of Figure 2A from an end view. [Figure 3A] Another example of an electrical applicator with a funnel-shaped electrode is illustrated. Figure 3A shows an unfolded electrical applicator extending from an elongated external catheter. [Figure 3B] Another example of an electrical applicator having a funnel-shaped electrode is shown. Figure 3B is a side view of the electrical applicator. [Figure 3C] Another example of an electrical applicator having a funnel-shaped electrode is illustrated. Figure 3C is an end view showing the distal end of the unfolded electrical applicator. [Figure 4A] These images show experimental results of an electrical applicator, similar to those shown in Figures 1A-1B and 2A-2B. In this example, the electrical applicator was operated as a unipolar electrode on a tissue model, for example, a sliced ​​potato (energy was applied to multiple sites). Figure 4A shows the tissue model after 23 hours of application of 100 pulses of 200 ns (8 Hz) at 5 kV. [Figure 4B] These images show experimental results of an electrical applicator, similar to those shown in Figures 1A-1B and 2A-2B. In this example, the electrical applicator was operated as a unipolar electrode on animal tissue (energy was applied to multiple sites with different parameters). Figure 4B shows the tissue 4-4.5 hours after 100 pulses of 200 ns (6 Hz) were applied at either 5 kV or 7 kV. [Figure 5A] Figures 1A-1B and 2A-2B show images of experimental results from an electrical applicator, which in this example operates as a bipolar electrode. Figure 5A shows a tissue model 23 hours after 100 pulses of 200 ns (8 Hz) were applied at 12 kV. [Figure 5B] Figures 1A-1B and 2A-2B show images of experimental results from an electrical applicator operating as a bipolar electrode on animal tissue (energy applied to multiple sites with different parameters), similar to those shown in Figures 1A-1B and 2A-2B. Figure 5B shows tissue 5-4.5 hours after 100 pulses of 200 ns (6 Hz) were applied at either 10 kV or 12 kV. [Figure 6A] Another modification of the electrical applicator described herein is illustrated, in which the distally oriented funnel-shaped electrode region is configured to be manipulated, for example, using one or more tendons. Figure 6A shows the electrical applicator in a neutral position, with the funnel-shaped electrode region deployed distally along the long axis of the device. [Figure 6B] Another modification of the electrical applicator described herein is illustrated, in which the distally facing funnel-shaped electrode region is configured to be operated, for example, using one or more tendons. Figure 6B shows the electrical applicator with the funnel shape operated in a downward position. [Figure 6C] Another modification of an electrical applicator as described herein is illustrated, in which a distally oriented funnel-shaped electrode region is configured to be steered, for example, using one or more tendons. Figure 6C shows an example of an electrical applicator that bends at the distal end region to steer or direct the distally oriented funnel-shaped electrode region. [Figure 7A] The effect of the electrical applicator of this disclosure, used to apply nanosecond pulses to a test tissue (e.g., potato), is illustrated. Figure 7A shows the surface of the test tissue 24 hours after the application of nanosecond pulses. [Figure 7B] The effect of the electrical applicator of this disclosure, used to apply nanosecond pulses to a test tissue (e.g., potato), is illustrated. Figure 7B shows both sides of a cross-section of the test tissue, illustrating penetration into the tissue, of the same sample tissue as in Figure 7A. [Figure 8A] Another example of an electrical applicator having a funnel-shaped electrode is illustrated, in which a second conductive region (e.g., a second electrode) within the funnel shape is configured to fold when the device is unfolded. Figure 8A shows the device in its unfolded configuration. [Figure 8B] Another example of an electrical applicator having a funnel-shaped electrode is illustrated, in which a second conductive region (e.g., a second electrode) within the funnel shape is configured to fold when the device is unfolded. Figure 8B shows the device in its unfolded configuration. [Figure 9A]Another example of an electrical applicator having a pair of funnel-shaped electrodes, shown in a non-expanded configuration, is illustrated. Figure 9A is shown in a perspective view of a non-expanded elongated braided or woven material before it is expanded (e.g., the outer member, e.g., the outside of the catheter) but before the inner expanding member is retracted proximal to form a pair of concentric funnels, as shown in Figures 10A-10B below. [Figure 9B] Another example of an electrical applicator having a pair of funnel-shaped electrodes, shown in a non-deployed configuration, is illustrated. Figure 9B shows a side view of the non-deployed device of Figure 9A. [Figure 10A] An example of a cross-section of an electrical applicator is shown, each having a pair of funnel-shaped electrodes used for treating tissue. Figure 10A shows an electrical applicator including a pair of funnels, each having an electrode on it, used for treating tissue (for example, for pyloric ablation). [Figure 10B] Figure 10B shows an example of a cross-section of an electrical applicator, each having a pair of funnel-shaped electrodes used to treat tissue. Figure 10B shows another example of an electrical applicator, similar to that shown in Figure 10A, having a pair of funnels with electrodes on the distal end region, used, for example, to ablate the pyloric sinus (including, but not limited to, ablating the pyloric sinus orifice). [Figure 10C] An example of an applicator similar to those shown in Figures 10A and 10B, but with a centering guide extending distally from the device, is illustrated. [Figure 10D] An example of an applicator similar to those shown in Figures 10A and 10B, but with a centering guide extending distally from the device, is illustrated. [Figure 11A] An example of an electrical applicator having a funnel-shaped electrode with a first outer diameter is shown. [Figure 11B] Figure 11A shows the device partially retracted into the outer catheter so that the outer diameter is reduced to a smaller outer diameter. [Figure 12A]An example of an electrical applicator having a funnel-shaped electrode with a second conductive region (electrode) that can be positioned in an adjustable manner relative to its longitudinal position is shown. Figure 12A shows the electrical applicator in a non-deployed configuration. [Figure 12B] An example of an electrical applicator having a funnel-shaped electrode with a second conductive region (electrode) that can be positioned adjustable relative to the longitudinal position is shown. Figure 12B shows a device in an unfolded configuration in which a braided or woven body is turned back onto itself and inverted to form a funnel shape, with one or more electrodes on the distal end region. [Figure 13A] Another example of a funnel-shaped electrical applicator is illustrated, in which a braided or woven material forming the funnel is pre-formed into a funnel shape but is held in a non-expanded folded configuration (as shown in Figures 13A-13B) and extends distally out of the catheter (as shown in Figures 13C1 and 13C2) allowing it to expand. [Figure 13B] Another example of a funnel-shaped electrical applicator is illustrated, in which a braided or woven material forming the funnel is pre-formed into a funnel shape but is held in a non-expanded folded configuration (as shown in Figures 13A-13B) and extends distally out of the catheter (as shown in Figures 13C1 and 13C2) allowing it to expand. [Figure 13C] Another example of a funnel-shaped electrical applicator is illustrated, in which a braided or woven material forming the funnel is pre-formed into a funnel shape but is held in a non-expanded folded configuration (as shown in Figures 13A-13B) and extends distally out of the catheter (as shown in Figures 13C1 and 13C2) allowing it to expand. [Figure 13D] Another example of a funnel-shaped electrical applicator is illustrated, in which a braided or woven material forming the funnel is pre-formed into a funnel shape but is held in a non-expanded folded configuration (as shown in Figures 13A-13B) and extends distally out of the catheter (as shown in Figures 13C1 and 13C2) allowing it to expand. Figure 13D shows a distal end view of the device in Figures 13A-13C. [Figure 14]These are examples of funnel-shaped electrical applicators, similar to those shown in Figures 13A to 13D. [Figure 15] An example of a system including an electrical applicator and a pulse generator for high-voltage, high-speed pulsed electrical energy delivery is illustrated. [Figure 16] A schematic illustration shows an example of a method of treating a patient by applying energy using one of the devices described herein. [Modes for carrying out the invention]

[0062] This specification describes applicators for delivering electrical energy to tissue, having a funnel shape that may include one or more electrodes on the distal end region of the funnel shape. Additional electrodes may be positioned within the opening of the distal funnel shape. These applicators may be configured for unipolar or bipolar operation and may be used to treat tissue, including the delivery of nanosecond pulsed energy to target tissue, such as high-voltage sub-microsecond (e.g., nanosecond, picosecond, etc.) electrical energy.

[0063] The electrical applicators described herein may generally include a body that forms a distal funnel shape, or is configured to unfold to form a distal funnel shape. The body may be formed from a braided and / or woven material. The braided or woven material may be a conductive material that is insulated over most of the body but can be exposed to form one or more conductive regions (e.g., electrodes) on the distal end region of the funnel shape, etc. The material may be, for example, a conductive polymer, a shape memory alloy (e.g., a nickel-titanium material such as nitinol), stainless steel, etc. The material may be insulated with a polymer material. The material may be formed from one or more strands or filaments, or a bundle of strands or filaments (including wires). In some modifications, the braided or woven material is formed from or is a non-conductive material (e.g., a polymer material) and includes one or more strands of a conductive material to form a distal conductive region. In some modifications, most or all of the braided or woven material is formed from a conductive material. Many of the examples provided herein involve braided or woven materials forming a body (e.g., forming a funnel shape), but any of the examples provided herein may instead use a sheet of material, such as a laser-cut sheet of material. The braided and / or woven materials may be fibrous materials (including natural fibers, synthetic fibers, etc.), polymer materials, etc. For example, the material forming the woven, braided, or knitted material (e.g., stranded wire) may be one or more of monofilament polymers, multifilament polymers, NiTi filaments, NiTi tubes with radiopaque metal centers, cobalt-chromium alloy filaments, cobalt-chromium alloy tubes with radiopaque metal centers, nylon, polyester, polyethylene terephthalate, and polypropylene. The sheet of material (e.g., a solid sheet of material) may be one or more of polymer materials (e.g., PTFE), silicone materials, polyurethane, shape memory alloys, stainless steel, etc. The sheet may be extruded, bonded, etc. The sheet may be cut to form pores and / or protrusions. For example, the sheet may include one or more laser-cut protrusions.Any of these devices may be coated with a hydrophilic coating and / or a hydrophobic coating, and / or may contain pores.

[0064] In some variations, the body forming the funnel shape may be woven. The woven body may contain multiple strands (e.g., 8 to 100, 10 to 70, 20 to 60, etc.). As described above, some or all of the strands may be formed from a conductive material that can be insulated. The insulator may be removed over areas forming conductive areas or electrodes, such as the distal end region and, in some examples, outside or at the ends of the distal end region. Similarly, the body may be formed from a braided material, for example, multiple strands braided together to form the material of the body. Woven areas may be formed by braiding (and referred to as “braided” areas). In some variations, the body may be formed from a braided material, such as braided filaments. Thus, in general, all of these braided areas, knitted areas, and woven areas (including those from laser-cut sheets) may be referred to as “braided or woven” bodies or “braided or woven” materials.

[0065] The electric applicators described herein may include an elongated proximal region that can be handheld (for example, by a user) or may be coupled to a movable arm of a robotic system, and the operation of the electric applicator may be at least partially automated or fully automated, including computer-controlled operation.

[0066] Any of the electrical applicators described herein may be configured to unfold from a non-unfolded state, in which the electrical applicator has a narrower outer diameter and / or can be held within an external member such as an external catheter or cannula, to an unfolded state, in which the electrical applicator expands to form a funnel shape. In some examples, the electrical applicator includes a braided or woven body, formed like a tube, with the proximal end and distal end gathered together. The proximal end may be continuous with or connected to an elongated member such as a cannula or catheter. The distal end may be connected to an elongated puller or pusher (e.g., a microcatheter, guidewire, etc.) that passes through an elongated body to which the braided or woven body is attached, and this puller may be referred to as an internal unfolding member.

[0067] For example, Figure 1A illustrates an example of an electrical applicator 10 configured to form a funnel body shown in an un-expanded (or, as described later, partially-expanded) state. In this example, the braided or woven body 12 is formed from a woven shape memory alloy material (e.g., NITINOL) which can be shaped to have an expanded configuration, and for example, the intermediate region of the uninverted braided or woven body is flared. The intermediate region 31 of the braided or woven body may be configured as a conductive region (e.g., an electrode) by including one or more conductive materials in this region. The first conductive region may be referred to as an electrode or braided electrode. In this example, the first conductive region may be formed from some or all of the wires of the braided or woven body, which may be insulated in the proximal and distal regions but may be electrically exposed across this intermediate region 31 of the braided or woven body. The electrically exposed region may form one or more conductive regions. Electrically exposed regions may come into contact with each other to form a single continuous electrode, or electrically exposed regions may be separated from each other by insulating regions to form multiple electrodes on the braid or fabric. For example, the first conductive region may be a wire forming the braid or fabric, or may be formed from multiple exposed (uninsulated) regions of a conductive wire that may be added to the wire forming the braid or fabric. As shown in Figures 1A and 1B, if a wire in the intermediate region 31 of the braid or fabric is exposed around all or part of the periphery of this region, a funnel shape may be formed (as described later and shown in Figure 1B), and the distal end of the funnel shape may form a conductive region. The rest of the braid or fabric may be electrically insulated, for example, by insulating each individual wire with an electrically insulating coating, or by insulating them collectively. This prevents short circuits of applied electrical energy that may come into contact with other (non-target tissues) and / or blood or body fluids, for example, when used for endocardial or intracavitary applications.

[0068] In any of the devices described herein, one or more (e.g., two, three, four, five, six, etc.) conductive regions may be formed on or around the braid or fabric when inverted as shown in Figures 1B and 2A. Each region may be formed from the same wires forming the braid or fabric, or from one or more additional wires coupled to the braid or fabric. Each conductive region (electrode) may be electrically coupled to an electrical contact in the proximal end region of the device. For example, in a modified example in which the conductive regions on the braid or fabric are formed from the wires forming the braid or fabric, these wires may be electrically coupled at the proximal end of the braid or fabric to an electrical connector at or near the proximal end of the device. In some examples, the wires forming the braid or fabric may extend downward along the length of the elongated proximal body 50 extending proximal from the funnel shape.

[0069] In Figure 1A, the distal end of the braid or fabric is gathered and coupled to a collet connected to an inner unfolding member 16. The proximal end 14 of the braid or fabric is also gathered and coupled to an elongated proximal body 50 that extends proximal within the outer catheter 22 in Figures 1A and 2A. In any of these examples, another conductive region, such as an electrode or central electrode, may be contained within an opening formed by a funnel shape. In Figure 1A, the electrode 40 may be coupled (e.g., mechanically coupled) to the gathered distal end of the braid or fabric (e.g., the distal collet 26). This electrode may be referred to as a second conductive region (or central conductive region, or central electrode). In some examples, the central conductive region 40 is configured to be positioned in the same plane as the distally facing opening of the funnel shape, and therefore in the same plane as one or more electrodes 30 on and around the distally facing outer region of the funnel shape 55. The central conductive region 40 may be completely electrically insulated except for the distally facing surface.

[0070] The entire electrical applicator device may be configured for unipolar and / or bipolar operation. For example, the electrical applicator device may be configured for unipolar operation by electrically coupling one or more conductive regions around the distally oriented outer region with the central electrode 40, at least in part. For example, the conductive regions may be electrically coupled to wires forming the braid or woven body 12 (unipolar configuration). Alternatively, the central electrode may be electrically connected separately to a pulse generator and configured to have opposite polarity (bipolar configuration).

[0071] In the examples shown in Figures 1A and 1B, one or more conductive regions on the braided or woven fabric are formed on the funnel-shaped end, for example, the distal end region 34. In some modifications, the conductive region may extend slightly proximal and / or on the distally facing edge and / or extend within the funnel shape. In some examples, one or more conductive regions are located on the distally facing edge of the distally facing outer region.

[0072] In Figure 1A, the intermediate region is also configured to invert when the inner unfolding member 16 extending through the braided or woven body is pulled proximal, as shown in Figure 1B, forming a funnel shape or funnel 55 with a distal end region facing distally. The first conductive region may extend around the entire braided or woven body, or it may extend only partially around the distal end region 34 of the funnel shape 55.

[0073] The electrical applicators shown in Figures 1A and 1B may be configured for bipolar operation. Figure 1A shows the applicator before deployment, with the braided or woven body 12 extending distally and proximal. An inner deployment member 16 is coupled to the distal end of the braided or woven body and can also accommodate an electrical connection to a central electrode 40. The side surface 27 of this electrode is insulated. The device can be fully deployed by pulling the inner deployment member proximal, as shown in Figure 1B.

[0074] Figure 2A shows a front perspective view of another example of an electrical applicator device, similar to those shown in Figures 1A and 1B, including a braided or woven body 12 forming a funnel-shaped body. The distal end 26 may be pulled (for example, by pulling an inner unfolding member to unfold the funnel shape) and this distal end of the braided or woven body may be inverted into the braided or woven body itself. In this example, the shape is funnel-shaped (which may also be called outwardly flared or trumpet-shaped), but the inside of the funnel shape 55 is at least partially blocked by the end of the braided or woven body inverted into the braided or woven body itself. Figure 2B shows an end view of the distally facing opening formed by the funnel.

[0075] In each of these examples, the funnel shape can be compressed by pulling proximal to the end of the high-column-strength region 95 (as shown in Figure 1B), providing high column strength to form a more cylindrical distal end region 34, thereby improving the device's ability to press on tissue. Thus, the funnel shape 55 can be held under compression before and / or after unfolding. The wires forming the funnel body (braid or woven body) can be stacked relative to one another. Figures 2A and 2B show a top perspective view and a front (end view), respectively, of a funnel shape compressed to form this high-column-strength region 95.

[0076] The distal end region 34 of the funnel shape 55 in Figures 2A and 2B also includes one or more electrodes 30, at least partially positioned around the distal end. In some modifications, the central conductive region 40 may be open (for example, ring-shaped) to allow one or more elongated members (e.g., guidewires, scopes, etc.) to pass through the center of the device.

[0077] Figure 3A illustrates another example of an electrical applicator shown in an unfolded configuration, in which a braided or woven body is gathered and joined at the proximal end extending from an elongated proximal body 50. An inner unfolding member 16 is coupled to a collet 51, which is also coupled to the gathered distal end of the braided or woven body 12. In this example, the collet is also connected to a central conductive region 40. Figures 3B and 3C show similar examples of the electrical applicator shown unfolded with the braided or woven body formed in a funnel having a distally oriented outer region. In Figures 3B-3C, the central electrode (central conductive region 40) is open and can form a passage or channel into which another device or material (e.g., fluid) may be applied.

[0078] In Figures 1A-1B, 2A-2B, and 3A-3C, the electrical applicator devices each include a braided electrode, which may be constructed using conductive wires such as NiTi wire or stainless steel. For example, electrically insulated NiTi wire or other conductive material may be used for some or all of the strands forming the braid or fabric. The braid or fabric may be constructed on a metal mandrel, which is set to a desired diameter and shape after braiding to set the desired outer diameter of the braid or fabric. The braid or fabric may be formed within an electrode assembly, as shown, and may be coupled to the distal end of an elongated member (e.g., an elongated proximal body, in some examples a catheter), or may be used as part of a device that does not include an elongated member. Reversible electrodes may be formed into an unfolded configuration by pulling a tension mechanism (e.g., an internal unfolding member such as a rod, wire, catheter, or microcatheter) which may be attached to the distal end of the braid or fabric. When the tension mechanism is activated, the distal end of the braid or woven body is pulled proximal, causing the braid or woven body to invert inward on itself, forming a funnel-shaped contour which may have a distal end (or distal edge) on which one or more conductive regions (electrodes) can be formed. A central electrode may also be included and, as described above, may be configured to be located in substantially the same plane as the maximum diameter of the formed funnel.

[0079] The braided or woven body in Figure 1A can be considered partially unfolded because the body may initially be held within an outer cannula (not shown) that restricts the expansion of the braided or woven body, so that the entire braided or woven body has a small diameter. When the braided or woven body is extended by pushing the inner unfolding member and / or pushing distally from the gathered proximal end of the braided or woven body, for example in a modified example where the inner unfolding member is fixed to the gathered distal end of the braided or woven body, the braided or woven body may self-expand into the shape shown in Figure 1A. It may be further expanded as described above by pulling the inner unfolding member proximal to form a funnel shape, as shown in Figure 1B.

[0080] When a funnel-shaped electrical applicator is deployed in the body near a target area, the electrical applicator can be pressed against the tissue to be treated, and electrical energy (but not limited to) such as nanosecond pulsed electrical energy can be applied. For example, the device described herein may be configured to deliver energy to cardiac tissue. When inverted, the distal end of the device, which includes one or more braided electrodes, can be pressed against cardiac tissue together with the central electrode, and energy can be applied. In unipolar operation, the central electrode does not need to be used, or may be electrically coupled to an electrode on the braid or fabric. In a bipolar configuration, as shown in Figure 3A, both the central electrode and the outer electrode on the funnel shape formed by the braid or fabric are in contact with the tissue.

[0081] Figures 4A and 4B illustrate examples of tissue treated using an electrical applicator similar to the unipolar configuration described herein. In Figure 4A, the electrode applicator was used in a unipolar configuration such that a central electrode and a single peripheral electrode formed on the distal surface of an inverted braid or fabric were electrically coupled to each other and electrically coupled to a pulse generator. A separate return path (e.g., a grounding pad) may be used. In Figure 4A, energy from the pulse generator was applied to the test tissue (cut potato) at 5kV using 200ns pulses at 8Hz. 100 pulses were applied. The image was taken 23 hours after energy was applied and shows three treated areas 401. Similar results were observed using animal tissue, as shown in Figure 4B. In Figure 4B, the image was taken 4–4.5 hours after application of the unipolar nanosecond pulses applied as described above, using 5kV or 7kV for 100 pulses at 200ns / pulse at 6Hz.

[0082] Figures 5A and 5B show the results with an electrical applicator in a bipolar configuration as described herein. In this example, a central electrode and a single peripheral electrode formed on the distal surface of an inverted braid or fabric were each electrically coupled to a pulse generator to apply bipolar nanosecond pulsed electrical energy. In Figure 5A, energy from the pulse generator was applied to the test tissue (cut potato) at 12kV using 100 pulses of 200ns each at 8Hz. The image was taken 23 hours after energy application. Three treatment areas are shown. Similar results were observed using animal tissue, as shown in Figure 5B. This was taken 4.5–5 hours after application of bipolar nanosecond pulsed stimulation using 100 pulses of 200ns / pulse at 6Hz, at 10kV or 12kV. In this example, the bipolar configuration resulted in a fairly uniform distribution of energy to the tissue.

[0083] The reversible braided electrode designs described herein may generally be used as the distal portion of an electrode applicator in devices for tissue treatment, such as for the treatment of atrial fibrillation, ventricular tachycardia, and other cardiac ablations. These electrode applicators may also be used to apply nanosecond pulsed electric fields to other parts of the body. Alternatively or additionally, these electrical applicators may be used to apply other types of electrical energy, such as radio-frequency (RF) electric fields and / or micropulse electric fields. As described above, these reversible electrical applicators may be part of catheter devices, scope devices, laparoscopic devices, endoscopic devices, etc. (for example, they may include an elongated proximal body extending proximally from a funnel-shaped distal end). Such devices may be used, for example, during minimally invasive procedures and / or as part of surgery, such as (but not limited to) cardiac surgery. Specifically, these devices can be used in procedures where it may be desirable to treat a specific area of ​​tissue (e.g., ablation), for example, because they can expand from a relatively narrow diameter within the lumen of a catheter to a much larger diameter including an electrode.

[0084] The distance between the outer electrode and the inner electrode (for example, the central electrode and one or more electrodes formed at least partially around the distal outer region of the electrode) can vary. Therefore, the same applied voltage can vary the strength of the applied electric field.

[0085] Any of the electrical applicator devices described herein may be configured such that the distal end is maneuverable. Thus, the distal funnel-shaped region may be maneuverable. The distal end region may be maneuverable by manipulating one or more tendons that can be pulled and / or pushed from the proximal end region of the device. In some modifications, the distal end region (e.g., the funnel-shaped region) may be attached to one or more tendons and used to pull and / or push proximally in order to maneuver the distal end region. For example, Figure 6A shows an example of an electrical applicator device that may be configured as any of the devices described herein, such as Figures 1A-1B, 2A-2B, 3A-3C, 8A-8B, 9A-9B, 10A-10D, 11A-11B, and 12A-12B. In Figure 6A, the device 610 includes a fabric 12 that forms a funnel shape 32 at the distal end when the fabric inverts over itself during deployment. The central electrode 40 may be at least partially surrounded by one or more electrodes 30 on the periphery of the funnel shape (e.g., on the distal end region 34). The bending region 56 may be located at or near the interface between the elongated body 50 and the funnel 32. The bending region 56 may include one or more rotational regions, such as vertebrae or regions of variable stiffness, which can provide predictable bending 622 in one or more directions. As described above, the device may include one or more (e.g., two or more, three or more, etc.) tension wires or tendons (not shown in Figures 6A-6B) that can be attached to the funnel-shaped portion to provide maneuverability by bending the bending region 56. In Figure 6B, the distal end region of the device, including the funnel shape 32, is shown deflected downward.

[0086] Figure 6C illustrates an example of an electrical applicator, such as those shown in Figures 6A and 6B, which bends approximately 10 to 270 degrees in the bending region 56. In Figure 6A, the inner unfolding member (not shown) is pulled proximal to the center electrode 40, which is surrounded by a funnel shape 32 containing one or more electrodes. The bending region 56 may include a hinge region (e.g., regions of different stiffnesses) so that the distal end can be deflected and bent by pulling a tension wire or tendon (not shown). The amount of bending may depend on the amount the tension wire or tendon is displaced. Thus, the device can be manipulated in the body.

[0087] Electrical applicator devices, such as those shown in Figures 1A-1B and 2A-2B, were also tested on tissue models (e.g., potatoes), and the results are shown in Figures 7A-7B. In Figure 7A, damage to the test tissue was created by applying bipolar nanosecond pulsed energy, as described above. The images in Figures 7A and 7B were taken 24 hours after the energy was applied. As shown, relatively large (e.g., 12 mm in diameter) and uniform damage was formed by the energy application. The depth of penetration is illustrated in Figure 7B (in Figure 7B, the tissue model is cut through the damage, and two cut pieces of the model tissue are placed side by side). As can be seen, the depth of penetration was approximately 5.5 mm within the model tissue.

[0088] In any of these devices, the central electrode (second conductive region) may be formed from a solid electrode (as shown in Figures 1A-1B, 2A-2B, and 3A-3C), or from a braided or woven material similar to or identical to the electrode formed on the funnel-shaped body. For example, Figures 8A and 8B illustrate an example of an electrical applicator (e.g., a reversible braided electrode) in which both the funnel-shaped body containing one or more electrodes and the central electrode are formed from a braided or woven material (e.g., wire). These two may be formed from the same braided or woven body, or from two separate braided or woven regions. In Figure 8A, the electrical applicator 810 includes a braided or woven body 812 that extends proximal to distal, is gathered at the proximal end, and is coupled to an elongated proximal body (e.g., a catheter) 850. The braided or woven region may be configured to form a distal end region 834 of a distally facing funnel shape when the device is unfolded. One or more electrodes on the braided or woven funnel body may be formed on or from the portion of the braided or woven that becomes the outer edge of the distally facing funnel shape when the device is inverted, as described above. For example, one or more electrodes on or around the distally facing outer region may be formed by removing the insulator from the conductive wires forming the braided or woven.

[0089] In this example, the distal end of the braided or woven body is connected to a collet or ring 826, to which the second braided or woven body 840 is joined at a single gathered proximal end. The distal end of this second braided or woven body 840 is connected to an inner puller, which may be configured as an inner unfolding member 816. By pulling the inner unfolding member 816, the second braided or woven body 840 can be compressed (towards the central electrode 840'), and the first braided or woven body 812 can be inverted to form a funnel-shaped body, and as shown in Figure 8B, the second braided or woven body 840 functions as a flattened central electrode 840'. In this example, the central electrode can be positioned within the funnel-shaped distal opening 830, which can potentially expand to a larger diameter than is possible with conventional solid electrodes, and the unfolded configuration can be made compact for, for example, movement through a catheter. In some examples, the first braid or fabric and the second braid or fabric may be parts of the same braid or fabric. In some examples, a separate inner unfolding member may be used to invert the first braid or fabric to form a funnel shape and / or to flatten the second braid or fabric to form a central electrode.

[0090] Any of the devices described herein (e.g., electrical applicators or any system including them) may be configured to have two or more distally oriented funnels, which may be arranged concentrically, in addition to or instead of a central electrode. For example, Figures 9A-9B, 10A-10D, and 11A-11B illustrate examples of electrical applicator devices including a pair of concentrically arranged funnels, each containing one or more electrodes on a distally oriented outer region. Figure 9A shows a schematic diagram of an example of a device including a braided or woven body configured to form a first funnel shape from a first (proximal) portion of the braided or woven body and a second funnel shape (e.g., from a second distal portion of the braided or woven body). The first funnel shape may be arranged concentrically around the second funnel shape. In Figure 9A, the device is shown in a state that is not fully unfolded. The device includes a first braid or fabric 966 and a second braid or fabric 968, separated by a neck member 933. An inner unfolding member 916 may be coupled to the end of the second braid or fabric 968 and may be slidable within the neck member 933, and by pulling the inner unfolding member 916 proximal, both the first braid or fabric for forming the first (outer) funnel shape and the second braid or fabric for forming the second (inner) funnel shape can be inverted. Alternatively, in some examples, the first braid or fabric and the second braid or fabric may be nested (e.g., concentrically) or, in some examples, arranged side by side, and may be unfolded separately by coupling to separate inner unfolding members, which may be coupled to the distal ends of the first braid or fabric and the second braid or fabric, respectively. Figure 9B shows a side view of the same device as shown in Figure 9A. Both devices may optionally include a central electrode 940. The first and second fabrics may each include peripheral regions 924, 924' (or 925) that, when unfolded, buckle or bend to form a funnel-shaped distal end. One or more electrodes may be positioned on or incorporated within each of these peripheral regions, such that one or more electrodes are present on each distal end, as described herein. The central electrode may be electrically insulated from one or more electrodes on the braids or fabrics 966, 968.

[0091] Figures 10A and 10B illustrate an example of an electrical applicator having a pair of concentric funnels in an unfolded configuration (similar to those shown in an unfolded state in Figures 9A and 9B). Each funnel may include one or more electrodes positioned at least partially around the distal outer region of the funnel (e.g., the distal edge and / or the outer edge region and / or the inner edge region). An optional central electrode 1040 may also be included. The central electrode may be positioned at the end of an inner puller 1016, which is coupled to the distal end 1026 of the mesh forming the inner funnel. In Figure 10A, the first electrode 1030 is included on the distal outer region of the first funnel 1033 and may be on the inner surface of the funnel, and the second electrode 1030' is included on the distal outer region of the second funnel 1033' and may be on the outer surface of this portion of the funnel, as shown. This may allow the device, when operating in a bipolar configuration, to apply energy between the funnels at the distal end opening, thereby applying energy to the tissue from the electrode on one funnel to the electrode on the other funnel. In Figure 10A, the device may be used, for example, as part of a pyloric sinus ablation procedure. The device may circumferentially ablate tissue 1080, 1082 between two funnel-shaped bodies. Figure 10B shows another example of an electrical applicator device in which the shapes of the inner and outer funnels may differ from those shown in Figure 10A. Figure 10B illustrates a method for ablating the sinus opening of a blood vessel 1085. The device may be similar to those shown in Figures 9A-9B. During operation, the device may be used as part of a catheter procedure for delivery in a non-expanded configuration into a body cavity such as a blood vessel. When near the target area of ​​tissue to be treated (e.g., to be ablated), the device can be extended distally and deployed, as described above, for example by pulling the inner deployment member proximal (and / or by advancing the proximal end of the first braid or fabric distally). This can form the inner and outer funnel members, as shown. As previously stated, the funnel shape can be formed without inversion, when deploying the device involves, for example, simply allowing the linear device to expand to form a funnel-shaped configuration.

[0092] In some cases, the devices described herein may be used to detect or sense electrical signals from tissue either before or during operation, including before or during ablation. For example, these devices (either in inverted or linear configurations) may be used to pace the heart. This can be performed, for example, across a pair of electrodes on the catheter itself, or from the catheter to a separate electrode (for example, on a distal element of the catheter, such as a coronary sinus (CS) catheter). Thus, any of these devices can be used for mapping cardiac tissue with or without ablation. For example, one or more electrodes on a braided or woven material may be used for mapping with a central electrode or on an electrode on a separate device (e.g., a catheter). Near-field and / or far-field electrographic signals can be sensed by the device. In some cases, the device may be used to sense electrical activity (e.g., electrographics) from tissue to determine areas to ablate or further ablate.

[0093] Any of the devices described herein may also include a centering guide (centering feature) to assist in positioning the device within the tissue. Thus, any of these devices may include a centering guide to assist in positioning the device so that the electrodes are directed relative to the tissue. In some examples, the device may include a centering guide for positioning the device's electrodes relative to the wall of a blood vessel or ventricle, for example, to the sinus / oral region of a blood vessel such as the pulmonary veins of the heart, enabling proper positioning and more efficient ablation while achieving pulmonary vein isolation (PVI). In some embodiments, navigating the device (e.g., toward the pulmonary veins) and properly positioning the device can be difficult, and depending on the situation, if the device is positioned unevenly (e.g., in the sinus of the PV or another target location), the desired ablation may not be achieved. The centering guide may be expandable and / or foldable. Furthermore, the centering guide may be configured to be positioned proximal to the distal end region (including the funnel) and / or positioned distal to both the distal end region and the funnel.

[0094] For example, Figures 10C and 10D illustrate an example of an electrical applicator having a centering guide 1095 that extends distally from concentric funnels 1033, 1033' to assist in positioning the device, so that electrodes 1030, 1030' can be directed to the tissue and / or hold the electrodes in contact with the tissue. In Figures 10C and 10D, the centering guide is shown as an expanding member that expands into the lumen of the sinus orifice of a blood vessel 1085. The centering guide extends from the distal end of an internal puller 1016.

[0095] Any of the devices described herein may include a centering guide. For example, the centering guide may be located on the distal end (e.g., of an internal deployment member) or on the proximal end proximal to the funnel, for example, on the distal end region of a deployment member such as a cannula. The centering guide may be expandable (e.g., a balloon, basket, spline, rib, etc.). In some examples, the centering guide is inflatable. In some examples, the centering guide is a basket (such as a braided, woven, or woven) that is expanded and / or folded, released or captured by a cannula or by connection to one or more tendons (e.g., a pull / push wire, etc.). Thus, any of the devices described herein may include one or more additional centering guides, which may be part of the device or additional devices that can be used in conjunction with the device, to enable centering to an anatomical structure to which treatment is applied, such as (but not limited to) a vascular lumen. Generally, the centering guide may be an expandable, non-traumatic projection that may extend distally from or around the distal end region of the device. Alternatively, the centering guide may be configured to temporarily fix the device in place within the body (e.g., a body cavity). Thus, any of these centering guides may also be referred to as anchors. Any of these devices may further or additionally use a guidewire for positioning the device. For example, a balloon or spline may have a built-in guidewire or a lumen for a guidewire that may be used to introduce the device. In some examples, the centering guide may also function as an electrode for applying pulsed energy to tissue, or may include an electrode.

[0096] As described above, the diameter of the funnel portion (and therefore the size and shape of the electrodes) may be adjustable. Figures 11A and 11B illustrate an example of an electrical applicator device having an adjustable outer diameter. In Figure 11A, the braided electrode device may be the same as those shown in Figures 1A and 1B, 2A and 2B, 3A and 3C, or 8A and 8B. In this example, the proximal end of the braid or fabric 1124 may be held within an outer member such as a catheter 1150. In Figure 11A, the device is shown with the funnel unfolded and the proximal end of the braid or fabric potentially coupled to an elongated body (e.g., a catheter) that extends proximal to the funnel and extends out of the outer catheter 1150. In this configuration, the funnel shape has a first diameter d11139. This diameter can be reduced by drawing the proximal end of the funnel shape (for example, the proximal end of the braided or woven body 1124) into the outer catheter 1150, as shown in Figure 11B. In Figure 11B, the outer diameter of the funnel is reduced to d21141.

[0097] In any of the devices described herein, the central electrode may be adjustable in the longitudinal direction. For example, when applying energy to a tissue surface from an electrical applicator device, it may be desirable to have the central electrode in the same plane (e.g., coplane) as one or more electrodes on the distal outer region of the funnel shape. In examples such as those shown in Figures 11A-11B, where the distal opening of the funnel shape has an adjustable diameter, the most distal edge of the funnel shape may change as the diameter of the funnel shape changes. Therefore, it may be beneficial to provide modifications in which the longitudinal position of the central electrode can be adjusted.

[0098] Figures 12A and 12B illustrate an example in which the central electrode (or a group of central electrodes) is adjustable by including a positioning member that extends proximal to the central electrode within the braided or woven body, allowing the longitudinal position of the second conductive region to be adjusted relative to the distal outer region of a funnel shape. This positioning member may extend within or adjacent to the inner unfolding member (in devices including an inner unfolding member). The positioning member may be an elongated structure having sufficient column strength to press the electrode, such as a rod, wire, cannula, or microcannula.

[0099] In Figure 12A, the electrical applicator 1210 includes a braided or woven body 1224, shown in its un-deployed state. The device may extend from an outer deployment cannula 1222. An inner deployment member 1216 may be attached to the distal end of the braided or woven body, and in Figure 12A, a tubular or ring-shaped stopper structure (e.g., a collet 1226) is coupled to both the distal end of the braided or woven body and the inner deployment member. A positioning member (shown as a rod 1205) may be coupled to the central electrode 1240 and may be adjusted proximal by moving it from distal to proximal on the device (as indicated by arrow 1209 in Figure 12B) to adjust the position of the central electrode. The positioning member may pass through the collet 1226. In some modifications, the positioning member may also be the same as the inner deployment member, which can be pulled back to deploy the device into a funnel shape, and the funnel shape may be maintained even when the inner deployment member is advanced distally to position the central electrode. As described above, the device may be configured to preferentially buckle or bend in the intermediate region of the braid or woven body (e.g., the braid or woven body) to form a funnel having a distally facing outer end, and one or more electrodes 1230 may be arranged on or around this distally facing outer end. In this example, a tubular ring or fastener (e.g., a collet) may be coupled to the distal end of the braid or woven body, while the inner unfolding member may slide laterally (e.g., distal to proximal) within the ring or fastener.

[0100] The central electrode structure can also be formed from a deployable structure, for example, from a braided or woven material such as a NiTi braided wire, as described above, and therefore the diameter of the outer electrode can vary depending on the outer diameter of the NiTi braid.

[0101] Reversible braided electrodes (e.g., electrical applicators) as described herein can be used in any application for surface ablation. For example, these devices can be used for bipolar point-by-point ablation, even for relatively large area ablation, such as for pulmonary vein isolation (PVI) in the left atrium (LA) to treat atrial fibrillation (AF). To access the LA of the heart, femoral vein puncture may be performed using a needle under fluoroscopic and / or ultrasound guidance. After puncture under fluoroscopic guidance, a 0.032-inch J tip guidewire is advanced. The needle may be removed, and a sheath introducer (usually 8-12F) may be inserted into the vein and then flushed. A transseptal sheath and dilator may be advanced along the guidewire to the superior vena cava (SVC). When the sheath reaches 3-4 cm above the vena cava-atrial junction, the wire may be removed. The transseptal puncture needle can then be advanced under fluoroscopic guidance until it reaches the tip of the sheath. The needle is advanced with the stylet inserted until it reaches approximately 4 cm from the tip. The stylet can prevent the needle tip from scraping the internal lumen of the sheath. The stylet can then be removed. The puncture can be performed and the sheath can be advanced into the LA. The catheter with a reversible braided electrode can then be introduced into the LA through the sheath, and the distal end of the catheter, including the central electrode, is retracted via a mechanism in the catheter's handle. As a result of the described retraction, the braided or woven material can expand and then retract on itself, forming a funnel shape with the central electrode and one or more electrodes on the distal end of the funnel-shaped outer region, which can be positioned coplanar with each other. The deployed electrical applicator can be used in a unipolar or bipolar configuration as described above. As described above, when the device is used in a unipolar configuration, the neutral (e.g., a grounding electrode such as a grounding pad or a dispersed electrode) connected to the pulse generator may be placed in contact with the patient's body.

[0102] In some examples, the devices described herein can be unfolded from a compression configuration in which the funnel shape is already formed. For example, Figures 13A to 13D illustrate an example of an electrical applicator having a funnel shape in which a braided or woven body 1324 is already formed into a funnel shape but is held within an outer (e.g., unfolded) cannula 1322. In Figure 13A, the device may be pushed distally from the proximal end of the device to extend the device out of the outer cannula, and / or the outer cannula may be pulled proximal (as shown in Figure 13B) to extend the funnel shape out of the outer cannula, and may self-expand into a funnel shape as shown in Figures 13C1 to 13C2. All or part of this outer funnel shape may be a conductive region (e.g., an electrode) 1330. For example, as described above, the distal end region may be an electrode, or part of the annular distal end region may be an electrode. The device may also include a central electrode 1340 in the funnel opening, as shown in Figure 13D.

[0103] In any of these electrical applicator devices (e.g., devices), the internal unfolding member may be configured to form a funnel shape having a distally facing outer region, where a first conductive region may be formed at least partially around the distally facing outer region. The size (e.g., diameter) of the conductive region on the distally facing outer region may be adjustable so that the therapeutic size (and / or shape) can be adjusted. The size can be controlled by controlling the expansion of the funnel shape. For example, in Figures 13A–13D, the funnel shape 1324 may be configured to self-expand when released from the unfolding cannula 1322, as shown in Figures 13C1 and 13C2. In Figure 13C1, the cannula 1322 is only partially retracted proximal (arrow 1333) so that the funnel 1324 partially expands, for example, from a folded diameter d1 (shown in Figure 13B) to an intermediate diameter d2 (shown in Figure 13C1). The relative position of the cannula and the funnel shape 1324 having a distal outer region 1334 can be controlled to select the diameter of the distal outer region 1334, and therefore the diameter and shape of the first conductive region 1330 (first electrode) formed around the distal outer region 1334. The first conductive region 1330 may be configured to expand and contract as the distal outer region 1334 expands and contracts. For example, the distal outer region may be formed from multiple electrically connected regions (forming a single conductive region, e.g., an electrode), as described herein, or it may be formed from one or more conductive elements that are flexible and / or coupled around the distal outer region, for example in an S-shape or zigzag pattern, allowing for expansion and contraction with the distal outer region.

[0104] By moving the cannula 1322 further proximal, the distal outer region of the funnel shape can be further expanded to a maximum expanded diameter d3, as shown in Figure 13C2. In this example, the first conductive region 1330 (first electrode), formed around the distal outer region 1334 of the funnel 1324, is fully expanded. The funnel, and therefore the distal outer region and the first electrode (conductive region), may be foldable to a smaller diameter (e.g., any diameter between and including d1 and d3) by moving the cannula distally, or the funnel may be enlarged or expanded by retracting the cannula proximal. In this example, the second conductive region 1340 is configured to be surrounded by the distal outer region and therefore the first conductive region 1330 for applying energy between the first electrode (conductive region 1330) and the second electrode (second conductive region 1340). In any of these examples, the second conductive region may be coupled to the inner unfolding member, and as a result, the funnel shape may be initially formed by extending a distal end having a braided, woven, or woven region that extends outward from the delivery / unfolding member, or by retracting the delivery / unfolding member proximal to the delivery / unfolding member. The funnel shape may be folded within the unfolding cannula 1322, as shown in Figures 13A-13B.

[0105] Figure 14 shows another example of an electrical applicator device that is pre-formed into a funnel shape 1467 but can be compressed into an unfolded configuration as described above. This example also includes a braided or woven body 1424 and a distally facing outer region having a rim 1434, along which one or more electrodes 1430 may be formed or joined. The funnel shape may be formed by self-expansion after the device has been moved distally relative to the outer cannula 1422, or alternatively or additionally, the device may be unfolded by pulling the distal end of the braided or woven body proximal. As described above, multiple electrodes may be formed in the distally facing outer region of the funnel shape by exposing some uninsulated regions of the wires forming the braided or woven body in the distally facing outer region. One or more conductive wires forming each electrode region may form electrodes, and the electrodes may be separated from each other by insulating regions. In some examples, multiple conductive contacts, such as wires or other electrodes, may be positioned on the braid or fabric, and each may be electrically connected to one or more conductive wires of the braid or fabric to form an individual electrode.

[0106] Any of the electrode applicators described herein may also be configured to be coupled to a pulse generator for delivering high-voltage sub-nanosecond pulses into target tissue. Specifically, the electrical applicator (apparatus, device, or system comprising them) may be configured to isolate the high-voltage power applied by the pulse generator from the operator's hands to prevent accidental injury to the operator. In some modifications, the connection to the pulse generator may be an electrical cable connected to the electrical applicator distal to the handle. In some modifications, the electrical cable connection to the pulse generator may be connected to the handle or proximal to the handle. In some modifications, the electrical applicator may not include a handle.

[0107] Any of the devices described herein may be configured to deliver a fluid, such as a conductive solution (e.g., saline solution), to the electrode region, and specifically, between the first conductive region and the second conductive region (or additional conductive region). The addition of saline solution to these regions may help prevent arc discharge. For example, when applying the applicator device to tissue, such as a relatively flat area of ​​tissue (e.g., on the surface of the abdominal cavity), a conductive solution, such as saline solution, may be applied from the distal end of the device during the application of electrotherapy, such as submicrosecond pulses, as described herein. Any of the expandable funnels described herein may include a coating or layer to prevent or limit the passage of a fluid (e.g., saline solution, blood, etc.) through the funnel region. Thus, in some examples, a local area of ​​a known conductive solution, such as saline solution, can be maintained by using a fluid-impermeable barrier added to the funnel to limit or prevent the fluid from leaking through the funnel. For example, any of these devices may include an inner layer on the mesh or material forming the funnel region to make it relatively impermeable to saline solution.

[0108] For example, returning to Figures 11A and 11B, which show a device that forms a distal funnel 1124 when the inner member 1151 is pulled proximal, in some examples the inner member 1151 may also include one or more ports for the delivery of a fluid (e.g., saline solution). The distal end of the funnel shape (or cone shape) may also form a fluid-impermeable barrier for holding saline solution adjacent to the electrodes (first electrode and second electrode).

[0109] As described above, any of these devices may be configured to be part of the distal end of a catheter or cannula, and / or may be used at the distal end of a catheter or cannula. Alternatively, in any of these examples, the features described herein relating to a catheter or cannula may be similarly applied to a scope (e.g., an endoscope, laparoscope, etc.), depending on the type of deployment used in the particular example or embodiment.

[0110] Figure 15 illustrates an example of a system 100 (also referred to herein as a high-voltage system or sub-microsecond generating system) for delivering high-voltage, high-speed pulses of electrical energy, which may include an electrical applicator device 102, a pulse generator 107, a foot switch 103, and a user interface 104. The foot switch 103 is connected to a housing 105 (which may enclose electronic components) via a cable and connector 106. The elongated applicator device (e.g., a catheter) 102 may include electrodes and is connected to the housing 105 and the electronic components therein via a cable 137 and a high-voltage connector 112. The high-voltage system 100 may also include a handle 110 and a storage drawer 108. The system 100 may also include a holder (e.g., a holster, carrier, etc.) (not shown) which may be configured to hold the elongated electrical applicator device 102. The system may be configured for unipolar operation of an electrical applicator device and may optionally include a grounding pad 152 or other neutral (dispersive) electrode that is electrically connected to the patient to whom the treatment is delivered. A return electrode may be coupled to the system by a cable 157 of any appropriate length that can be plugged into the system.

[0111] In some cases, the applicator catheter includes imaging capabilities such as one or more cameras and / or optical fibers located at or near the distal end of the applicator catheter. The cameras may be forward-facing and / or lateral-facing. System 100 may be configured to display (in real time and / or recorded) the images captured by the applicator catheter in order to identify a target region.

[0112] A human operator may select pulse count, amplitude, pulse duration, and frequency information by, for example, inputting such parameters into a numeric keypad or touchscreen on interface 104. In some embodiments, the pulse width can be varied. The controller may transmit signals to pulse control elements within system 100. In some embodiments, fiber optic cables are used to enable the transmission of control signals while simultaneously electrically isolating the contents of the submicrosecond generation system 100, e.g., a metal cabinet with high-voltage circuits, from the outside. To further electrically isolate the system, system 100 may be battery-powered rather than being powered from a wall outlet.

[0113] As described above, any of the devices described herein can be implemented in a robotic system that can be used to position and / or control electrodes during treatment. For example, the robotic system may include a movable (robot) arm to which an elongated applicator tool is coupled. Various motors and other moving devices can be incorporated to enable fine movement of the working end of the elongated applicator tool in multiple directions. The robotic system and / or the elongated applicator tool may further include at least one image acquisition device (preferably two or more for stereoscopic vision) that can be mounted in a fixed position or coupled (directly or indirectly) to the robotic arm or other controllable moving device. In some embodiments, the image acquisition device may be incorporated within the elongated applicator tool.

[0114] Any suitable nanosecond-scale pulse can be applied. For example, the pulse profile may also include rise and / or fall times of the pulse, which may be less than 20 ns, about 20 ns, about 25 ns, about 30 ns, about 40 ns, about 50 ns, about 60 ns, about 75 ns, or greater than 75 ns. In some embodiments, the pulse voltage may be less than 5 kV, about 5 kV, about 10 kV, about 15 kV, about 20 kV, about 25 kV, about 30 kV, or greater than 30 kV. In some embodiments, the current may be less than 10 A, about 10 A, about 25 A, about 40 A, about 50 A, about 60 A, about 75 A, about 100 A, about 125 A, about 150 A, about 175 A, about 200 A, or greater than 200 A. In some embodiments, the pulse duration may be less than 10 ns, about 10 ns, about 15 ns, about 20 ns, about 25 ns, about 30 ns, about 40 ns, about 50 ns, about 60 ns, about 75 ns, about 100 ns, about 125 ns, about 150 ns, about 175 ns, about 200 ns, about 300 ns, about 400 ns, about 500 ns, about 750 ns, about 1 μs, about 2 μs, about 3 μs, about 4 μs, about 5 μs, or greater than 5 μs. The apparatus (e.g., system) described herein may include, in addition to the instrument (e.g., elongated applicator tool), a pulse generator, such as the one schematically shown in Figure 15, configured to emit pulses in the sub-microsecond range.

[0115] How to use the device For example, any system and / or device (e.g., devices, etc.) described herein may be used to treat a patient's tissue, including, but not limited to, methods and uses for using systems and / or devices such as those described herein to treat anatomical structures or tissues, such as the walls, lumens, passages, cavities, or blood vessels of any tissue, including, but not limited to, the walls, lumens, passages, cavities, or blood vessels of any tissue, such as veins, arteries, blood vessels, heart, trachea, pharynx, larynx, bronchi, ureters, urethra, fallopian tubes, cervix, uterus, intestines (large and / or small intestines), pancreas and pancreatic ducts, liver and hepatic ducts, rectum, esophagus, stomach, nasal cavity, seminal vesicles, and bronchi. The systems, devices and techniques disclosed herein are particularly useful with non-thermal pulsed electric fields (e.g., nanosecond pulsed electric fields), but in some embodiments they may also be used with a variety of other energy modes, including (but not limited to) radio frequency (RF). While the devices and systems of this disclosure find applications in tubular anatomical structures, these devices, systems and techniques may also be used to apply treatment to non-tubular structures and surfaces, including substantially flat ones. For example, such a device may be introduced from a smaller body cavity into a larger cavity and then expanded to apply energy to a flat, non-tubular surface using, for example, only some of the electrodes on an expandable member. Anatomical cavities, tubes, lumens, passages, or blood vessels are referred to herein as body cavities or lumens. In some examples, the body cavity may include various blood vessels (e.g., pulmonary veins), and the devices and methods of the present disclosure may be useful, among other things, for the treatment of various cardiac conditions such as atrial fibrillation. In another non-limiting example, the devices and methods of the present disclosure may be used for the treatment of endometriosis or vocal cord fold conditions. Electrodes for delivery of treatment may include, for example, one or more electrode assemblies fixed to the surface of an expandable structure (e.g., as shown in the examples in Figures 1 to 14), which are deployed from a catheter or other deployment member and configured to fit, for example, a portion of the wall of a body cavity.

[0116] In general, the devices described herein may be used to treat tissue by deploying the device to the target tissue to be treated, and may include: deforming the device into a funnel-shaped configuration; positioning it in or near the target tissue (e.g., face-to-face or circumferentially to the wall to be treated); and applying energy through the device between, for example, a first conductive region (e.g., around all or part of the distally oriented funnel) and a second conductive region that may be within the funnel shape. For example, Figure 16 illustrates an example of a method for treating target tissue. In some embodiments, the device may be deployed by optionally retracting the inner deploying member of the electrical applicator proximal to invert the distal end region of the braid or fabric of the electrical applicator to form a funnel shape having a distally oriented outer region (step 1601). In other implementations, the device may be deployed in step 1601 without inverting the distal end region of the braid or fabric, for example, by allowing the device to self-expand into a funnel-shaped configuration. Once deployed, the distal end region of the funnel shape can be positioned on or near the target tissue. For example, the first conductive region on the distal outer region of the device can be positioned in contact with the target tissue such that a second conductive region, surrounded by the distal outer region within the funnel shape, also contacts the target tissue (step 1603). Next, energy (including, but not limited to, electrical energy in the submicrosecond range, e.g., the nanosecond range) can be applied from the device, for example, by applying a plurality of electrical pulses having an amplitude of at least 0.1 kV and a duration of less than 1000 nanoseconds to the target tissue from the first and second conductive regions (step 1605).

[0117] Any of the devices described herein may be used to treat the pulmonary system (e.g., lungs, pulmonary arteries, etc.) by inserting the device into the pulmonary system or a portion thereof in a non-deployed configuration, and then deploying the device to treat lung tissue, for example. In some examples, as described above, the method may include treating liver (e.g., liver) tissue, which involves inserting the device into contact with a target area of ​​liver tissue. Generally, these methods may be used to treat "flat" tissue, or tissue that is not limited to tubular structures.

[0118] Any of these devices can be used to treat heart disease. When used for cardiac applications, the devices may be used within the heart (e.g., within the chambers of the heart such as the ventricles and atria) and / or within the monitored blood vessels and channels.

[0119] The devices described herein may be used to treat endometriosis. For example, a physician (e.g., a surgeon) can make a small incision near the patient's navel and insert a slender visual instrument (laparoscope) to look for signs of endometrial tissue outside the uterus. Thus, the devices described herein may be configured to work with a laparoscope or to be used as part of a laparoscope. These devices can provide information about the location, extent, and size of endometriosis, or information about a device for treating endometriosis. The devices may also be used to ablate tissue, including tissue affected by endometriosis, by applying energy to ablate, including preferentially ablating such tissue. In some examples, the tissues described herein may be coupled to the end (distal end region) of a rigid or semi-rigid scope (e.g., an endoscope, laparoscope, etc.). Similarly, these methods and apparatus may be used to treat vocal cord folds and vocal cords (e.g., vocal cord polyps), including ablation / removal of vocal cord folds / tissue on the vocal cords, or modification of vocal cord folds / vocal cords.

[0120] In general, the examples and methods described herein may include the treatment of a subject (e.g., a human or animal patient) by applying therapeutic energy, including but not limited to short, high-field-intensity electrical pulses, while minimizing or avoiding the risk of damaging non-target tissues. These examples and methods may be used in minimally invasive procedures and may be particularly suitable for the treatment of a variety of conditions, disorders and diseases, including (but not limited to) benign tumors, cancerous or precancerous tumors, lesions, and other types of abnormal tissue growth. These examples and methods may also be particularly suitable for use with a variety of fully automated and partially automated systems, such as robotic systems. The devices described herein may be configured as devices (e.g., catheter devices, cannula or scope systems, other minimally invasive devices and control systems, etc.) that can be used with a variety of different energy generating systems. Examples of cancers that can be treated include, but are not limited to, lung cancer, kidney cancer (e.g., renal cancer), pancreatic cancer (e.g., pancreatic cancer), colorectal cancer (e.g., colon cancer), breast cancer, and prostate cancer. Examples of tumors that can be treated with the devices and methods of this disclosure include benign prostatic hyperplasia (BPH), uterine fibroids, and tissues associated with Barrett's esophagus. Any of these methods and devices can be used percutaneously, either alternatively or additionally, to insert the device into the skin through an incision.

[0121] In general, the devices described herein may be used to apply treatment to or through a lumen (e.g., intraluminally). For example, a prostate tumor (e.g., cancer) may be treated by advancing a device (e.g., a flexible catheter) having an electrical applicator (e.g., an expandable funnel having a distally oriented annular electroactive region) transurethrally through the patient's urethra. Alternatively, as described above, the device may be inserted into the body through an incision and applied percutaneously to the tissue to be treated. Transurethral delivery may involve the insertion of a treatment device configured to include an expandable funnel having a distally oriented annular electroactive region (or simply an expandable one lined with peripheral electrodes) at its end, or configured to extend into the prostate through the urethra from the end of a catheter inserted through the penis, and specifically, energy including pulsed submicrosecond (e.g., nanosecond) energy may be applied to the tumor tissue.

[0122] Generally, the apparatus of the present disclosure may include additional elements such as a power supply and / or a high-voltage connector for securely connecting an elongated applicator tool device to a high-voltage power supply. As described above, these systems and devices are configured to apply high-voltage, sub-microsecond pulsed electrical energy.

[0123] The electric applicators described herein may be of any suitable length (e.g., about 4 inches to about 200 inches, about 4 inches to about 100 inches, about 4 inches to about 30 inches, about 6 inches to about 50 inches, about 6 inches to about 25 inches, about 7 inches to about 24 inches, etc.) and may have any suitable outer diameter in the unfolded and / or unfolded state.

[0124] Embodiments of the methods of this disclosure can be implemented using computer software, firmware, or hardware. Various programming languages ​​and operating systems can be used to implement this disclosure. A program that runs the methods and systems may include separate program code containing a set of instructions for performing a desired operation, or may include multiple modules that perform such suboperations of the operation, or may be part of a single module of a larger program that provides the operation. The modular structure facilitates the addition, deletion, updating, and / or modification of internal modules and / or features within modules.

[0125] In some embodiments, the user can select a particular method or embodiment for this application, and the processor executes a program or algorithm related to the selected method. In certain embodiments, various types of position sensors can be used. For example, in certain embodiments, a non-optical encoder can be used, which can achieve a desired angle, velocity, or force by adjusting the voltage level or polarity as a function of encoder signal feedback.

[0126] Certain embodiments may relate to a machine-readable medium (e.g., a computer-readable medium) or a computer program product containing program instructions and / or data (including data structures) for performing various computer implementations. A machine-readable medium can be used to store software and data that cause a system to perform the methods of this disclosure. The machine-readable medium described above may include any suitable medium that can store and transmit information in a form accessible by a processing device, such as a computer. Some examples of machine-readable media include, but are not limited to, hard disks, floppy disks, magnetic disk storage devices such as magnetic tapes. This may also include flash memory devices, optical memory devices, random access memory, and the like. Data and program instructions may also be embodied on a carrier wave or other carrier medium. Examples of program instructions include both machine language, such as that generated by a compiler, and files containing high-level code that can be implemented using an interpreter program.

[0127] Any of the methods described herein (including user interfaces) may be implemented as software, hardware, or firmware, and may be described as a non-temporary computer-readable storage medium storing a set of instructions that can be executed by a processor (e.g., a computer, tablet, smartphone, etc.) to cause the processor to perform or control the execution of any of the steps including, but not limited to, displaying, communicating with a user, analyzing, changing parameters (including timing, frequency, intensity, etc.), determining, warning, etc. In some exemplary embodiments, the present disclosure can be implemented by using hardware in combination with software instructions.

[0128] Where a feature or element is referred to herein as "on top of" another feature or element, it may be directly present on the other feature or element, or there may be intervening features and / or elements. In contrast, where a function or element is referred to as "directly present" on another function or element, there is no intervening function or element. Where a feature or element is referred to as "attached," "connected," "mounted," or "combined" to another feature or element, it may be directly attached, connected, mounted, or combined with the other feature or element, or there may be intervening functions or elements. In contrast, where a feature or element is referred to as "directly attached," "directly connected," "directly mounted," or "directly combined" to another feature or element, there is no intervening feature or element. Features and elements described or shown in relation to one embodiment may be applicable to other embodiments. It will also be understood by those skilled in the art that a reference to a structure or feature positioned "adjacent" to another feature may overlap with or have a portion beneath the adjacent feature.

[0129] The terms used herein are intended solely to describe specific embodiments and are not intended to limit them. For example, as used herein, the singular forms “a,” “an,” and “the” are intended to include the plural forms unless the context clearly indicates otherwise. As used herein, the term “and / or” includes any combination of one or more of the listed items relating to them.

[0130] Spatially relative terms such as “under,” “below,” “lower,” “over,” and “upper” may be used herein to describe the relationship between one element or feature and another, as shown in the diagram, for the sake of clarity. It will be understood that spatially relative terms are intended to encompass different orientations of a device in use or operation, in addition to the orientation shown in the diagram. For example, if the device in the diagram is inverted, an element described as “under” or “beneath” another element or feature is oriented “over” that other element or feature. Thus, the exemplary term “under” can encompass both up and down directions. The device may be oriented in other ways (rotated 90 degrees or in other directions), and the spatially relative descriptors used herein may be interpreted accordingly. Similarly, terms such as “upwardly,” “downwardly,” “vertical,” and “horizontal” are used herein for illustrative purposes only, unless otherwise specified.

[0131] The terms “first” and “second” may be used herein to describe various features / elements (including steps), but unless the context indicates otherwise, these features / elements should not be limited by these terms. These terms may be used to distinguish one feature / element from another. Thus, the first feature / element discussed below may be called the second feature / element, and similarly, the second feature / element discussed below may be called the first feature / element without departing from the teachings of this apparatus and method.

[0132] When used herein (including the claims), the terms “contains” and / or “contains” specify the presence of the described features, steps, actions, elements, and / or components, but do not exclude the presence or addition of one or more other features, steps, actions, elements, components, and / or groups thereof. Unless otherwise required by context, “contains,” and variations such as “contains” and “contains,” mean that various components can be used together in methods and articles (e.g., compositions and apparatus including devices and methods). For example, the term “comprising” would be understood to mean including the described elements or steps, but not to exclude other elements or steps.

[0133] Any apparatus or method described herein may include all or a subset of components and / or steps, which may be non-exclusive (e.g., including additional components and / or steps) or, in some modifications, exclusive, and thus may be expressed as "consisting of" or alternatively "essentially consisting of" various components, steps, auxiliary components, or auxiliary steps.

[0134] Where used in the specification and claims of this specification, and including where used in the examples, all numbers, unless otherwise specified, can be read as if preceded by the words “about” or “approximately,” even if the term is not explicitly indicated. The phrases “about” or “approximately” may be used when describing size and / or location to indicate that the value and / or location described is within a reasonable expected range of the value and / or location. For example, a number may have values ​​such as + / -0.1% of the stated value (or range of value), + / -1% of the stated value (or range of value), + / -2% of the stated value (or range of value), + / -5% of the stated value (or range of value), + / -10% of the stated value (or range of value), etc. Also, numbers described herein should be understood to include about or approximately that value unless the context implies otherwise. For example, if the value “10” is disclosed, “about 10” is also disclosed. Any numerical ranges listed herein are intended to include all subranges contained therein. While various exemplary embodiments are described above, several modifications can be made to these embodiments without departing from the scope of the disclosure, as described in the claims. For example, the order in which the steps of the various methods described are performed may often be changed in alternative embodiments, and in other alternative embodiments, one or more steps of the method may be skipped entirely. Optional features of the various device and system embodiments may be included in some embodiments and not in others. Therefore, the foregoing description is provided primarily for illustrative purposes and should not be construed as limiting the scope of the devices and methods described in the claims.

[0135] In this specification, for the sake of convenience only, and without the intention to arbitrarily limit the scope of this application to any single invention or concept of invention, when two or more inventions are actually disclosed, various embodiments may be referred to individually or collectively by the term “invention.” Thus, while certain embodiments have been illustrated and described herein, any configuration calculated to achieve the same objective can be used in place of the specific embodiments shown. This disclosure is intended to cover all possible adaptations or variations of various embodiments. Combinations of the embodiments described above, and other embodiments not specifically described herein, will be apparent to those skilled in the art upon consideration of the above description.

Claims

1. A bipolar electric applicator device, wherein the device is A braided or woven body having a distal end and a proximal end, The distal end region of the braided body or woven body that forms a funnel shape having a distally oriented outer region, A first ablation electrode of one polarity, at least partially formed around the distal outer region of the funnel shape, A second ablation electrode of a different polarity, configured to contact the tissue to be ablated and positioned at least partially within the funnel-shaped opening but away from the funnel shape, Electrical applicator devices, including

2. The device according to claim 1, wherein both the first ablation electrode and the second ablation electrode are configured to be positioned in contact with the tissue to be ablated.

3. The device according to claim 1, wherein the second ablation electrode is arranged along the longitudinal axis of the center of the funnel shape.

4. The device according to claim 1, wherein the operation of the first ablation electrode and the second ablation electrode is computer-controlled.

5. The device according to any one of claims 1 to 4, wherein the device is configured to deliver microsecond, nanosecond, or picosecond electrical pulses.

6. The device according to any one of claims 1 to 4, wherein the braided body or woven body includes a conductive wire.

7. The device according to claim 6, wherein the first ablation electrode is formed from an uninsulated portion of the conductive wire.

8. The device according to any one of claims 1 to 4, wherein a portion of the braided body or woven body located proximal to the distal outer region is electrically insulated.

9. The device according to any one of claims 1 to 4, wherein the second ablation electrode comprises a solid material or a solid.

10. The device according to any one of claims 1 to 4, wherein the second ablation electrode includes a braided material or woven material that is similar to or different from the material of the braided body or woven body.

11. The device according to any one of claims 1 to 4, wherein the braided body or woven body is pre-formed into the funnel shape and compressed within the outer cannula before deployment, and further configured to self-expand into the funnel shape when deployed from the outer cannula.

12. The device according to claim 11, wherein the size of the first ablation electrode is adjustable by controlling the expansion of the funnel shape.

13. The device according to any one of claims 1 to 4, further comprising a positioning member that extends proximal to the second ablation electrode within the braided body or the woven body and is configured to allow adjustment of the longitudinal position of the second ablation electrode with respect to the distal outer region of the funnel shape.

14. The device according to any one of claims 1 to 4, further comprising a third or more electrodes formed on the distal outer region.

15. The device according to any one of claims 1 to 4, wherein the size, outer diameter, and / or shape of either or both of the first ablation electrode and the second ablation electrode are adjustable.

16. The device according to any one of claims 1 to 4, wherein the device is configured for point-by-point ablation.

17. The device according to any one of claims 1 to 4, wherein the device is configured to be coupled to a movable arm of a robot system.

18. The device according to any one of claims 1 to 4, wherein the first ablation electrode and the second ablation electrode are on the same plane or not on the same plane when deployed.

19. The device according to any one of claims 1 to 4, further configured to detect an electrical signal from the tissue and determine whether to ablate or further ablate the region.

20. The device according to any one of claims 1 to 4, comprising a second region of the braided body or the woven body that forms or is configured to form a second funnel shape, wherein the second funnel shape has a second distally oriented outer region, and the second ablation electrode is located on the second distally oriented outer region of the second funnel shape.

21. The device according to claim 20, wherein one of the funnel shape or the second funnel shape is configured to overlap at least partially along the longitudinal axis and to concentrically surround the other.

22. The device according to claim 20, wherein the device is configured to ablate the tissue in a circumferential direction between the funnel shape and the second funnel shape.

23. The device according to claim 20, further comprising a third electrode surrounded by the distal outer region and the second distal outer region.

24. It is a system, An electric applicator according to any one of claims 1 to 4, A system comprising: a pulse generator configured to generate a plurality of electrical pulses having an amplitude of at least 0.1 kV, wherein an electrical applicator is configured to be electrically coupled to the pulse generator.

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