Multi-strip ablation and sensing catheter device and method

Abstract

Methods and apparatus for providing pulsed electrical therapy (including high voltage, sub-microsecond pulsed electrical energy) to tissue including cardiac tissue are disclosed. The device may include a deployable electrode conforming to the transition surface. The devices may include a single-layer or multi-layer wire loop forming petal electrodes and sensing (e.g., mapping, navigation, etc.) electrodes, including sensing electrodes located radially on either side of the electrode for application of therapy.

Description

[0001] Claiming priority

[0002] This patent application claims priority to U.S. patent application No. 18 / 353,867, filed on July 17, 2023, entitled “MULTI-STRUT ABLATION AND SENSING CATHETER DEVICES AND METHODS,” and U.S. patent application No. 18 / 046,784, filed on October 14, 2022, entitled “CIRCUMFERENTIAL ABLATION DEVICES AND METHODS,” now U.S. patent application publication No. US2023 / 0068059, each of which is incorporated herein by reference in its entirety. Background Art

[0003] Short high field strength electric pulses for the electrical manipulation of biological cells have been described. For example, electric pulses can be used to treat human cells and tissues. The voltage induced across the cell membrane can depend on the pulse length and pulse amplitude. Pulses greater than about 1 microsecond may charge the outer cell membrane and may cause permanent pore openings. Permanent openings may cause instantaneous cell death or near instantaneous cell death. Pulses shorter than about 1 microsecond may affect the interior of the cell without adversely or permanently affecting the outer cell membrane, resulting in a delay in cell death with intact cell membranes. Such shorter pulses whose field strengths vary in the range of, for example, 10kV / cm to 100kV / cm may trigger apoptosis (i.e., programmed cell death) in some or all cases where cells are exposed to the described field strengths and pulse durations. These higher electric field strengths and shorter electric pulses can be used to manipulate intracellular structures, such as nuclei, endoplasmic reticulum, and mitochondria. For example, this submicrosecond (e.g., nanosecond) high voltage pulse generator has been proposed for biological and medical applications.

[0004] In some cases, two or more electrodes are used to deliver electrical pulses, including high field strength electrical pulses, to a selected treatment area. The two electrodes may be configured for bipolar operation. The electrodes are placed in contact with tissue in the area to be treated. In some cases, the treatment area may have a varying or irregular shape. For example, the treatment area may transition from a first diameter to a second diameter. The varying diameters and / or irregular shapes may make it difficult for the electrodes to maintain constant and uniform contact.

[0005] Therefore, it may be beneficial to provide electrodes that can conform to varying and / or irregularly shaped treatment areas. Summary of the invention

[0006] Medical devices (e.g., apparatus, systems, etc.) and methods are described herein that can be used to perform medical procedures to treat patients. Specifically, the devices and methods described herein can be used to deliver short, high-field electrical pulses to perform ablation, e.g., circumferential ablation on body vessels including blood vessels and other lumens.

[0007] For example, described herein are devices and methods for treating the walls of anatomical structures, such as body passages, cavities, or vessels (e.g., veins, arteries, blood vessels, heart, trachea, pharynx, larynx, bronchi, ureters, urethra, fallopian tubes, cervix, uterus, intestines (large and / or small intestines), gallbladder, pancreas, rectum, liver, esophagus, stomach, nasal cavity, seminal vesicles, vas deferens, etc.) using pulsed electric fields, including (but not limited to) nanosecond pulsed electric fields, microsecond pulsed electric fields, etc. For ease of description, all such anatomical structures, cavities, tubes, lumens, passages, or vessels will be referred to herein as body vessels. In some examples, body vessels may include pulmonary veins, sinuses, and other appropriate lumens. Specifically, the methods and devices described herein may be configured to selectively treat body vessels having varying, transitional, and / or irregular surfaces. Electrodes conformable to body vessels may include a first electrode and a second electrode configured to be deployed from a catheter and conform to, for example, a portion of a wall of a body vessel and provide a sub-microsecond (e.g., nanosecond) pulsed electric field in a localized manner that limits or prevents damage to deeper non-target areas. In general, the electrodes described herein may be equivalently referred to as electrode assemblies; these electrodes (e.g., electrode assemblies) may include one or more active regions configured to apply energy to tissue, and one or more insulating regions.

[0008] The methods and apparatus described herein are not limited to vascular treatments, such as angioplasty treatments, but can be used to treat other body lumens where lumen narrowing may be a problem. For example, the lungs (airways), gastric chambers, catheters, etc. can be treated as described herein. In some examples, the apparatus and methods described herein are configured for otolaryngology use, for example, for insertion and treatment by applying sub-microsecond (e.g., nanosecond) pulsed electric fields in lumens or other otolaryngology structures (such as ears, noses or throats, including anatomical structures such as turbinates, tonsils, tongues, soft palates, parotid glands, and those structures connecting the larynx (pharynx) to the stomach). These apparatus and devices can be configured for insertion into these structures, for example, these apparatus and devices can be configured as elongated application tools, including catheters, tubes, etc., sized and shaped to fit in the ears, noses, throats, and / or treat associated anatomical structures (e.g., turbinates, tonsils, tongues, soft palates, parotid glands, etc.). For example, methods and devices configured to deliver sub-microsecond (e.g., nanosecond) pulsed electric fields to a portion of the gastrointestinal tract (e.g., stomach, small intestine, large intestine, duodenum, colon, etc., including but not limited to the esophagus) are described herein. Methods and devices configured to deliver sub-microsecond (e.g., nanosecond) pulsed electric fields to a portion of the respiratory tract (including the trachea, pharynx, larynx, bronchi, and bronchioles) are also described herein. Among other things, the methods and devices described herein are particularly useful in cardiac applications, including but not limited to the treatment of atrial fibrillation.

[0009] The devices described herein may include an elongated application tool (e.g., a catheter) that can be inserted into a body vessel or lumen, including but not limited to a blood vessel (artery, vein, etc.), esophagus, ear, nose, throat, trachea, pharynx, larynx, small intestine, large intestine, duodenum, colon, etc. These application tools may include an elongated flexible body extending in a proximal to distal direction. One or more (e.g., multiple) of the electrodes configured to deliver electrical pulses (e.g., nanosecond pulses) to the target tissue may be present at the end region of the flexible body.

[0010] The applicator ("applicator tool") can be configured to be removably coupled to a pulse generator configured to generate, for example, sub-microsecond (e.g., nanosecond) pulse energy, such coupling being performed by a handle proximal to a distal end region comprising an electrode. The electrode can be deployable and can be located on an expansion member that expands to contact the vessel wall. The handle can control deployment. Alternatively, in some cases, the applicator tool (also referred to herein as a device or apparatus) can be configured to be directly coupled to the pulse generator without a handle. According to one example, the devices described herein include medical devices and instruments for inserting an applicator tool into a lumen. These devices can be introduced into a blood vessel, for example, via an outer delivery catheter or a guide sheath.

[0011] Any of the devices described herein may be configured to function within a body region having a diameter that varies (e.g., from wider to narrower, or from narrower to wider), including regions having a conical or funnel shape. For example, some of the devices described herein may include at least two annular (elliptical, circular, etc.) electrodes having different diameters. In some examples, the diameters and / or lateral positions of these annular electrodes relative to each other may be adjustable.

[0012] In some examples, the applicator may include one or more contact projections (e.g., ribs, wires, springs, contact plates, contact posts, balloons, etc.) that can be manipulated, for example, by operating a proximal handle to which the applicator tool is coupled, to extend from the proximal end of the applicator. The contact projections can generally contact the wall of the lumen into which the applicator tool is inserted to enhance access to the tissue and contact of the abutting electrode with the tissue. For example, the contact projections can be inflatable elements (e.g., balloons) or mechanical elements (e.g., a pair of plates or a set of arms).

[0013] In one example, an applicator may include: an elongated body, such as an elongated catheter body; a first electrode formed by one or more rings having a first diameter and coupled to the elongated catheter body; and a second electrode formed by one or more different rings having a second diameter and flexibly coupled to the elongated catheter body. The first electrode and the second electrode may contact a body vessel, particularly a body vessel having an irregular, varying, or transitional surface. Either of these devices may include one or more mapping and / or sensing electrodes that may be positioned distally and / or radially outwardly of the first electrode and the second electrode.

[0014] In some examples, the first electrode and the second electrode can be divided into petals, wherein each petal is coupled to an elongated body (eg, an elongated catheter body) using an arm. In some examples, the first electrode and the second electrode can include two or more petals.

[0015] In some examples, the first electrode and the second electrode are coupled to the distal end region of the elongated body (which may be referred to as the elongated catheter body). In other examples, the first electrode and the second electrode may be movable within the elongated catheter body and may be configured to extend out of the elongated catheter body and collapse when retracted into the elongated catheter body. In some other examples, one of the first diameter and the second diameter is smaller than the other. In yet other examples, the first electrode is positioned distally relative to the end of the elongated catheter body (e.g., the distal end of the elongated catheter body), and the second electrode is disposed between the first electrode and the distal end of the elongated catheter body.

[0016] In some examples, the first electrode and the second electrode are configured to contact a sinus associated with a pulmonary vein. In some other examples, the first conductor and the second conductor are configured to deliver pulsed electrical therapy, wherein pulsed energy is transferred between the first conductor and the second conductor. In another example, the first conductor and the second conductor are configured to deliver pulsed electrical therapy, wherein energy is transferred between the first conductor and the third conductor or between the second conductor and the third conductor.

[0017] In some examples, the first conductor and the second conductor are configured to vary a distance therebetween.

[0018] For example, the present invention describes a device for delivering pulsed electric fields, which includes: a slender body; a plurality of arms configured to extend from the slender body at a certain angle in a deployed state; a first plurality of electrode segments, which extend between the plurality of arms and form a first treatment electrode; a second plurality of electrode segments, which extend between the plurality of arms and form a second treatment electrode, which is radially outside the first treatment electrode in the deployed state; and one or more mapping and / or sensing electrodes on an area extending radially outward from the second treatment electrode of each of the plurality of arms, and one or more mapping and / or sensing electrodes on an intermediate area between the first treatment electrode and the second treatment electrode of each of the plurality of arms.

[0019] Any of these devices may include a central electrode. For example, the central electrode may include a mapping and / or sensing electrode. The central electrode may be configured to extend distally from the distal end of the elongated body. In some examples, the central electrode also includes a central treatment electrode, wherein the central treatment electrode is configured to operate at a different polarity than at least one of the first treatment electrode or the second treatment electrode.

[0020] In any of these devices, the one or more mapping and / or sensing electrodes on the extended region may include an electromagnetic sensor coupled to the extended region of one or more of the plurality of arms.

[0021] At least some of the plurality of arms may include a hollow insulating member, and at least a portion of the first electrode or the second electrode and / or the electrical connector extends within or through the hollow insulating member. In some of these devices, each electrode segment of the first plurality of electrode segments forms an arc, and these arcs of the first plurality of electrode segments together surround the elongated body. The plurality of arms may be pre-bent or biased to bend at an angle to the longitudinal axis of the elongated body when extending from the elongated body. For example, at least one arm of the plurality of arms may be configured to bend to a different angle than at least another arm of the plurality of arms. The plurality of arms may include at least 3 arms, and the device may further include a third plurality of electrode segments that extend between the 3 arms and form a third treatment electrode.

[0022] In some embodiments, a device for delivering a pulsed electric field may include: an elongated body; a first plurality of arms configured to extend from the elongated body at an angle in a deployed state; a second plurality of arms configured to extend from the elongated body at an angle in the deployed state; a first plurality of electrode segments extending between the first plurality of arms and forming a first treatment electrode; a second plurality of electrode segments extending between the second plurality of arms and forming a second treatment electrode, the second treatment electrode being axially separated from the first treatment electrode by a plurality of struts; wherein the plurality of struts extend substantially parallel to a distal end region of the elongated body between the first treatment electrode and the second treatment electrode; and one or more mapping and / or sensing electrodes on at least some of the plurality of struts.

[0023] The one or more mapping and / or sensing electrodes may include a plurality of mapping and / or sensing electrodes, and at least some of the plurality of mapping and / or sensing electrodes are on either or both of the first plurality of arms and the second plurality of arms.

[0024] The braces of the plurality of braces may be coupled to at least one of the first plurality of arms and the second plurality of arms. For example, the first plurality of arms may be rotationally offset from the second plurality of arms. In some cases, the arms of the first plurality of arms and the second plurality of arms are configured to transition from an undeployed state, in which each of the plurality of arms is at least partially within the elongated body, to a deployed state, in which each of the first plurality of arms and the second plurality of arms extends from the elongated body at an angle.

[0025] In any of these devices, the arms of the first plurality of arms and / or the second plurality of arms are configured to extend from the elongated body at an angle of between 20 degrees and 90 degrees relative to the elongated body in a deployed state.

[0026] Any of these devices may include a central electrode configured to extend distally from a distal end of the elongated body, wherein the central electrode includes a mapping and / or sensing electrode. For example, a device may include a central electrode configured to extend distally from a distal end of the elongated body, wherein the central electrode includes a central treatment electrode. In some examples, the device is configured to apply bipolar energy between: 1) the central electrode and at least one electrode segment of a first plurality of electrode segments, 2) the central electrode and at least one electrode segment of a second plurality of electrode segments, and / or 3) at least one electrode segment of the first plurality of electrode segments and at least one electrode segment of the second plurality of electrode segments. In any of these devices, a distal end region substantially parallel to the elongated body may include an angle of up to plus / minus 10 degrees with respect to a longitudinal axis of the distal end region of the elongated body.

[0027] Also described herein is a device for delivering a pulsed electric field, the device comprising: an elongated body; a balloon on the elongated body; a first electrode, the first electrode comprising a first plurality of wire loops, wherein each of the first plurality of wire loops extends from the elongated body to form a petal arranged around the balloon, further wherein each of the first plurality of wire loops has a first active region extending along at least a portion of the length of each first wire loop; and a second electrode, the second electrode comprising a second plurality of wire loops, wherein each of the second plurality of wire loops extends from the elongated body, further wherein each of the second plurality of wire loops has a second active region extending along at least a portion of the length of each second wire loop, wherein the first electrode is laterally offset from the second electrode along the length of the balloon, further wherein each first active region in the first active region and each second active region in the second active region comprises a flexible bend, and the angle of the flexible bend is configured to expand as the balloon expands.

[0028] At least one or both of the first plurality of wire loops and the second plurality of wire loops may include 2 to 5 loops. In any of these examples, each of the first plurality of wire loops and each of the second plurality of wire loops may be coupled to the outer surface of the balloon at one or more points. For example, each of the first plurality of wire loops and each of the second plurality of wire loops may be slidably coupled to the outer surface of the balloon. In some examples, each of the first active regions and each of the second active regions are bounded on either side by an insulating region.

[0029] The first active region of each wire loop in the first plurality of wire loops may be spaced apart from the second active region of each wire loop in the second plurality of wire loops by a fixed distance. The first electrode and the second electrode may each be formed of a wire having a diameter less than 0.2 mm. In some examples, the first electrode is configured to have a first polarity and the second electrode is configured to have a second polarity.

[0030] It may be particularly helpful to include a distally (e.g., most distal) facing hinge region on the electrode. For example, the plurality of wire loops of the first electrode and the plurality of wire loops of the second electrode include a distal region configured as a hinge that expands or contracts as the balloon expands or contracts.

[0031] In some cases, it may be particularly helpful to arrange electrode rings (including an electrically continuous anode electrode and a separately electrically continuous cathode electrode) around the entire perimeter of the balloon. For example, the plurality of wire loops of the first electrode and the plurality of wire loops of the second electrode may be arranged completely around the circumference of the balloon.

[0032] Methods for delivering sub-microsecond pulsed electric fields to body vasculature may include: positioning an applicator including two or more electrodes within the identified treatment region, placing the two or more electrodes in contact with tissue within the identified treatment region, and applying pulsed electrotherapy via the two or more electrodes. These methods may be performed using any of the devices described herein. In some examples, placing the two or more electrodes in contact with tissue may include deploying the two or more electrodes from an elongate catheter body. In some other examples, the two or more electrodes may include a first electrode and a second electrode. The first electrode may include a plurality of electrode segments that are electrically connected to each other and extend between two or more arms extending from the elongate catheter body. The second electrode may include a plurality of electrode segments that are electrically connected to each other and extend between two or more arms extending from the elongate catheter body. Any of these methods may further include sensing electrical signals from tissue using: one or more mapping and / or sensing electrodes on an extension region radially outward from the second treatment electrode of each of the plurality of arms, and / or one or more mapping and / or sensing electrodes on an intermediate region between the first treatment electrode and the second treatment electrode of each of the plurality of arms.

[0033] In some examples, the first electrode may be disposed in the same plane or a different plane as the second electrode. In some other examples, the first electrode may be coplanar with the second electrode.

[0034] In some examples, the pulsed electrical therapy may include an electric field between a first electrode and a second electrode (e.g., between a first plurality of electrode segments and a second plurality of electrode segments). In another example, the pulsed electrical therapy may include an electric field between at least one electrode of the two or more electrodes and a third electrode (e.g., between the first plurality of electrode segments and / or the second plurality of electrode segments).

[0035] The devices described herein can generally be configured to safely and reliably deliver microsecond, nanosecond, picosecond, etc. pulses, and can include electric fields with pulse widths between 0.1 nanoseconds (ns) and less than 1000 nanoseconds or shorter (such as 1 picosecond), which can be referred to as sub-microsecond pulsed electric fields. The pulse energy can have a high peak voltage, such as 1 kilovolt per centimeter (kV / cm) to 5kV / cm, 10kV / cm, 20kV / cm, 100kV / cm or higher. In some applications, the pulse energy can be less than 1kV / cm. Treatment of biological cells can use multiple periodic pulses with a frequency range of 0.1 (Hz) to 100,000 Hz per second, and can trigger cell apoptosis, such as in ingrowth tissue that causes restenosis. Selective treatment of the vessel wall with high voltage, sub-microsecond pulsed energy can induce cell apoptosis in cells that cause restenosis, while substantially not affecting normal cells in surrounding tissues due to its non-thermal nature. The subject can be a patient (human or non-human, including animals). The user can operate the device described herein on the subject. The user may be a physician (doctor, surgeon, etc.), medical technician, nurse, or other care provider.

[0036] Thus, the application of high voltage, fast (e.g., microsecond or sub-microsecond) electrical pulses may include applying a train of electrical pulses having a pulse width, for example, between 0.1 nanoseconds (ns) and 1000 nanoseconds. Applying high voltage, fast electrical pulses may include applying a train of sub-microsecond electrical pulses having a peak voltage, for example, between 1 kilovolt per centimeter (kV / cm) and 500 kV / cm. Applying high voltage, fast electrical pulses may include applying a train of sub-microsecond electrical pulses having a frequency, for example, between 0.1 Hz and 100,000 Hz per second.

[0037] Any of these devices can be used with a pulse generator. For example, a system for treating tissue is described herein, which may include: an elongated applicator (e.g., an applicator tool) as described herein; a connector, such as a high-voltage connector suitable for coupling an elongated applicator tool to a pulse generator; 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, the pulse generator including a port configured to be connected to the high-voltage connector. In some examples, the applicator tool includes an elongated body having a distal end region, and one or more electrodes are configured to extend from the distal end region. In some examples, the distal end may be steerable (e.g., articulated). The device described herein includes a device that may be referred to as an applicator tool, and typically includes an applicator (or applicator region) for applying energy at or near the distal end region.

[0038] As mentioned, any of these devices may be configured so that the proximal end of the applicator tool is adapted to be coupled to a robotic arm or movable arm, for example for computer-controlled activation of the set of electrodes. Alternatively or in addition, the proximal end of the applicator tool may be adapted to be coupled to handles of a pulse generator, which in turn may be adapted to be connected to a robotic arm.

[0039] In some examples, as described above, the device may be configured to adjust the distance between the electrodes to apply treatment at the distal end region of the applicator. In some examples, the applicator includes at least two circumferentially arranged electrodes, each of which is circumferentially arranged around the support. The longitudinal position of one or two of the circumferentially arranged electrodes may be adjustable so that the distance between the circumferentially arranged electrodes may be increased or decreased. In some cases, the applicator may be adjustable to adjust the spacing between the circumferentially arranged electrodes to, for example, between 5mm and 40mm (e.g., between 10mm and 20mm, etc.). The circumferentially arranged electrodes may be electrode wire rings arranged into a plurality of petals (extending completely circumferentially around or partially circumferentially around the applicator), or they may be a plurality of individual electrodes circumferentially arranged around the applicator. Adjusting the spacing between the electrodes may allow the user to adjust and / or correct placement and allow the electrodes to fit within the inner wall or sinus, especially when the diameter / size of the vessel varies (including rapid changes) according to the longitudinal position. One electrode ring may fit one circumference, while the other electrode ring may fit a larger or smaller circumference, and in some examples, the spacing between the two electrodes may be adjusted.

[0040] In use, any of the devices described herein can be used to apply energy, including, inter alia, sub-microsecond (eg, nanosecond) pulsed fields. Sub-microsecond pulsed electromagnetic fields can induce apoptosis in cellular structures.

[0041] For example, described herein are devices for delivering pulsed electric fields within a body lumen (e.g., devices, systems, etc. including electrode applicators). These devices may include: an elongated body (e.g., an elongated flexible body); a first electrode, the first electrode including a first one or more rings, having a first active region formed on the first one or more rings, wherein the first active region is arranged to circumscribe the body lumen, and further, wherein the first one or more rings are flexibly coupled to a distal end region of the elongated body; and a second electrode, the second electrode including a second one or more rings, having a second active region formed by the second one or more rings, wherein the second active region is arranged to circumscribe the body lumen, wherein the second one or more rings are flexibly coupled to a distal end region of the elongated body, and further, wherein the first electrode is laterally offset from the second electrode along the distal end region of the elongated body. In any of these devices, one or more mapping and / or sensing electrodes may be positioned radially outward from the first active region and the second active region; and one or more additional mapping and / or sensing electrodes may be positioned radially between different electrodes.

[0042] In any of the devices described herein, each electrode of the device may include an elongated active region from which electrical energy is applied. For example, the active region may be a conductive (uninsulated) region of conductive material (e.g., a conductive wire, etc.) configured to emit electrical energy. In general, the devices described herein may include a first electrode having a first conductive region that extends across multiple lengths of different loops forming the first electrode (or in some examples, the second electrode). All loops of the first electrode (and therefore all sub-regions of the loops forming the active region) may be electrically coupled together to form a single anode or a single cathode; and all loops (and therefore all sub-regions of the loops) forming the second electrode are electrically coupled together as a single anode or a single cathode.

[0043] In any of these devices, the first electrode and / or the second electrode may be transverse to the distal end region of the elongated body, and / or the second electrode may be transverse to the distal end region of the elongated body. In any of these devices, the first electrode and / or the second electrode may include a first plurality of rings arranged as petals around the distal end region of the elongated body. The outer portion of each petal may form an active area for a single electrode. This configuration may allow for more robust treatment around the entire perimeter of the vessel without requiring multiple repositioning steps of electrode pairs to cover the same larger area around the circumference of the vessel.

[0044] In general, the diameter of the first active region of the first electrode may be smaller than the diameter of the second active region (e.g., the diameter of the ring forming the first electrode and the diameter of the second active region of the second electrode may be different). In some examples, the diameters of the rings forming the first electrode and the second electrode may be substantially the same.

[0045] Any of these devices may include an expandable frame. The expandable frame may be a balloon, a strut assembly, or the like. Generally, the first electrode and the second electrode may be coupled to the outer periphery of the expandable member so that they may circumscribe, at least partially, the periphery of the vessel. The expandable frame may support the first active electrode and the second active electrode. Thus, the first electrode and the second electrode may be arranged on the expandable frame. For example, the first electrode and the second electrode may be arranged on the expandable balloon.

[0046] In any of these examples, the first electrode and the second electrode can each be formed by a wire, for example, a wire having a diameter less than about 0.2 mm (less than about 0.19 mm, less than about 0.18 mm, less than about 0.17 mm, less than about 0.16 mm, less than about 0.15 mm, etc.).

[0047] In general, the first electrode and the second electrode are configured to flexibly conform to the body cavity so that the active area can extend circumferentially around the periphery of the cavity. As used herein, "arranged or configured to circumscribe the body cavity" may refer to extending at least partially around the circumference of the body cavity (e.g., in an arc of less than 360 degrees, such as about 270 degrees or greater, such as 300 degrees or greater, 320 degrees or greater, 330 degrees or greater, 340 degrees or greater, 340 degrees or greater, about 360 degrees). Therefore, the first active area arranged to circumscribe the body cavity may include an active area that extends completely or almost completely around the circumference of the cavity (extending about 270 degrees or greater, about 300 degrees or greater, about 320 degrees or greater, about 330 degrees or greater, about 340 degrees or greater, about 340 degrees or greater, about 360 degrees, etc. around the circumference of the cavity). In some examples, the first active area is configured to circumscribe the body cavity in an almost complete circle.

[0048] Any of these devices may include an outer catheter or guide sheath (e.g., an introducer or delivery catheter), wherein an elongated body forming or holding a first electrode and a second electrode may be slidably disposed within the outer catheter. The first electrode and the second electrode are configured to collapse when retracted or introduced into the outer catheter and / or to expand radially outward when extended out of the distal end of the delivery (outer) catheter.

[0049] The first electrode may be positioned distally relative to an end region of the elongated body, and the second electrode may be positioned proximally of the first electrode. In some examples, the longitudinal positions of the first and second electrodes may be fixed. In some examples, the longitudinal positions of the electrodes may be adjustable (e.g., variable). For example, the first electrode may be configured to slide axially proximally or distally relative to the second electrode, or vice versa.

[0050] In some examples, the first electrode may include an anode and the second electrode may include a cathode.The device may be configured to deliver pulsed energy between the first electrode (anode) and the second electrode (cathode).

[0051] In any of the examples described herein, the first active region and the second active region may each have a length longer than 5 cm. The first active region and the second active region may each have a diameter less than 0.2 mm.

[0052] The first electrode may be positioned distally relative to the distal end of the elongated catheter body, and the second electrode may be positioned between the first electrode and the distal end of the elongated catheter body.

[0053] In general, the device described herein is configured to advantageously apply energy between a first electrode and a second electrode in a circumferential region around a vessel in the body, without requiring multiple repositioning steps to treat the entire (or most) circumference. This solves the problem of many other electrical delivery systems, which respond to multiple discrete active regions that may leave gaps. The device described herein is particularly suitable for applying nanosecond pulses, but is not limited to such uses. Nanosecond pulse energy can work by entering cells in a non-thermal manner and changing the function of internal organelles (including mitochondria and endoplasmic reticulum). For example, nanosecond pulse electric fields cause intracellular destruction, which can cause regulated cell death. In examples where the energy applied is a nanosecond (or faster) pulse electric field, the active region of each electrode can be long and thin, such as formed by a wire, and the applied field can cause very little heat energy to be applied, thereby preventing damage to non-cellular tissues.

[0054] For example, the present invention also describes a method for delivering a pulsed electric field to a wall of a body vessel in a subject, the method comprising: positioning a first electrode comprising a first one or more wire loops and a second electrode comprising a second one or more wire loops within the body vessel, such that a first active area of ​​the first one or more wire loops is electrically connected to a first circumference of the wall, and such that a second active area of ​​the second one or more wire loops is electrically connected to a second circumference of the wall, the second circumference of the wall being longitudinally separated from the first circumference of the wall; and applying pulsed electrical therapy between the first active area and the second active area.

[0055] Positioning the first electrode and the second electrode may include deploying the first electrode and the second electrode from a delivery catheter by moving the delivery catheter relative to an elongated body coupled to the first electrode and the second electrode so that at least one of the first electrode and the second electrode expands from a delivery configuration (e.g., an undeployed state) to a deployed configuration (or deployed state). In some examples, deploying the first electrode includes contacting a wall with a plurality of electrically continuous wire segments of a first one or more wire loops. In some examples, deploying the second electrode includes contacting a wall with a plurality of electrically continuous wire segments of a second one or more wire loops. Deploying the first electrode may include expanding the first electrode to have a larger diameter than the second electrode. In some examples, deployment includes deployment in a sinus of a pulmonary vein. For example, deployment may include deploying the first electrode so that the first electrode is coplanar with the second electrode.

[0056] As mentioned, applying pulsed electrical therapy may include applying an electric field between the first active region and the second active region. Specifically, applying pulsed electrical therapy may include applying pulses having a nanosecond duration (less than 1000 ns duration).

[0057] In some examples described herein, a device may include: an elongated body extending from a proximal side to a distal side, wherein the elongated body is configured to be inserted into a body vessel; an applicator region located at a distal end region of the elongated body, the applicator region including: a first wire and a second wire, the first wire extending distally from the elongated body, the first wire having a first active region adjacent to a first insulating region of the first wire, the second wire extending distally from the elongated body, the second wire having a first active region adjacent to a second insulating region of the second wire; wherein the first active region is separated from the second active region by a minimum distance d, the minimum distance d being substantially constant along the length of the first active region; and further, wherein the first active region is configured to have a first polarity and the second active region is configured to have a second polarity. The first wire may include a first loop, and the second wire may include a second loop positioned concentrically relative to or within the first loop. In any of these devices, the first wire and the second wire may extend from the elongated body in a plane. In some examples, the insulating region and / or the elongated body can include a bend such that the first and second conductive wires extend at an angle relative to a long axis of the elongated body.

[0058] Also described herein are devices (e.g., apparatus, systems, etc.) for delivering pulsed energy in a point-by-point treatment or in a single treatment. Point-by-point treatment typically involves application to an area between two smaller electrically active areas, while a single treatment typically utilizes multiple electrically coupled active areas to treat a larger area.

[0059] Any of the devices described herein may be configured such that at least one of the first active area and the second active area is configured to circumscribe a wall of the anatomical structure in a partial, nearly complete, or complete circle.

[0060] Any of these devices may include a plurality of mapping and / or sensing electrodes located on a portion of the first electrode and / or the second electrode. For example, the sensing and / or mapping electrodes may be radially inward of the first active region and / or the second active region. The sensing and / or mapping electrodes may have a total surface area that is smaller than the surface area of ​​the electrically active region in the first electrically active region and / or the second electrically active region (e.g., 80% or less, 70% or less, 60% or less, 50% or less, 40% or less, 30% or less, 20% or less, 10% or less, 5% or less, etc. of the surface area). The sensing and / or mapping electrodes may be electrically isolated from the electrically active region and may each be connected or connectable to a mapping system and / or subsystem via one or more lines (e.g., wires, traces, etc.).

[0061] Also described herein is a device for delivering a pulsed electric field, the device comprising: an elongated body; a first electrode, the first electrode comprising a first wire loop, wherein the first wire loop flexibly extends from the elongated body, the first electrode having a first active region extending along the length of the first wire loop; and a second electrode, the second electrode comprising a second wire loop, wherein the second wire loop flexibly extends from the elongated body, the second electrode having a second active region extending along the length of the second wire loop, wherein the first electrode is radially offset, laterally offset, or both radially offset and laterally offset from the second electrode. As described above, any of these devices may include a plurality of mapping and / or sensing electrodes outside the first active region on the first electrode and / or outside the second active region on the second electrode.

[0062] Also described herein is a method for delivering a pulsed electric field to a wall of an anatomical structure in a subject using an applicator, the method comprising: positioning a first electrode of the applicator comprising a first one or more rings and a second electrode of the applicator comprising a second one or more rings in the subject such that a first active region of the first one or more rings forms a first contact ring electrically connected to a first region of the wall of the anatomical structure, and such that a second active region of the second one or more rings forms a second contact ring electrically connected to a second region of the wall of the anatomical structure, the second contact ring being radially and / or longitudinally separated from the first region of the wall of the anatomical structure; and applying a pulsed electrical therapy between the first active region and the second active region. Any of these methods may include: using one or more mapping sensors on the applicator to map the position of the applicator relative to the wall of the anatomical structure. Any of these methods may include: using one or more sensors on the applicator to sense one or more electrical properties of the wall of the anatomical structure before applying the pulsed electrical therapy and / or during applying the pulsed electrical therapy and / or after applying the pulsed electrical therapy.

[0063] Methods of using any of these devices are also described herein. Any of these methods may be a method of treating cardiac tissue, including ablating cardiac tissue. For example, a method for delivering a pulsed electric field to a wall of a heart in a subject using an applicator is described herein, the method comprising: positioning a first electrode of the applicator comprising a first one or more rings and a second electrode of the applicator comprising a second one or more rings in the subject, such that a first active region of the first one or more rings forms a first contact ring electrically connected to a first region of the wall of the heart (e.g., a pulmonary venous sinus, a pulmonary venous ostium, and / or other heart wall / muscle / tissue), and a second active region of the second one or more rings forms a second contact ring electrically connected to a second region of the wall of the heart, the second contact ring being radially and / or longitudinally separated from the first region of the wall of the heart; and applying pulsed electrical therapy between the first active region and the second active region. Any of these methods may include: using one or more mapping sensors on the applicator to map the position of the applicator relative to the wall of the heart. In some examples, the method may include: sensing one or more electrical properties of the wall of the heart using one or more sensors on the applicator before applying the pulsed electrical therapy and / or during applying the pulsed electrical therapy and / or after applying the pulsed electrical therapy. In any of these methods, the method may include mapping tissue (eg, a heart) using, for example, 3D electroanatomical mapping; in some examples, the method may include mapping or otherwise positioning an applicator on the map of tissue.

[0064] Also described herein are devices for delivering pulsed electric fields. The devices may include: an elongated body; an expandable member (e.g., a balloon) that may be located at a distal end region of the elongated body; a first electrode assembly that includes a first plurality of wire loops, each of which forms a petal having a first active region, wherein the first active region of each of the first plurality of wire loops is disposed around the expandable member and extends around all or at least a portion of a circumference of the expandable member; and a second electrode assembly that includes a second plurality of wire loops, each of which forms a petal having a second active region, wherein the second active region of each of the second plurality of wire loops is disposed around the expandable member and extends around all or at least a portion of a circumference of the expandable member, wherein the first electrode assembly is laterally offset from the second electrode assembly along the length of the expandable member, and wherein the first electrode assembly and the second electrode assembly are configured to expand radially outward when the expandable member is expanded.

[0065] For example, an apparatus for delivering a pulsed electric field may include: an elongated body; a balloon on the elongated body; a first electrode assembly including a first plurality of wire loops, each of the first plurality of wire loops forming a petal having a first active area disposed on the balloon; and a second electrode assembly including a second plurality of wire loops, each of the second plurality of wire loops forming a petal having a second active area disposed on the balloon, wherein each of the first active areas and each of the second active areas includes a flexible bend, the angle of the flexible bend (which may be oriented from distal to proximal / from proximal to distal) being configured to expand as the balloon expands so that the first electrode assembly and the second electrode assembly expand radially outward when the balloon expands, further wherein the first electrode assembly is laterally offset from the second electrode assembly along the length of the balloon. In some examples, the first electrode assembly and the second electrode assembly may be shaped to return to a radially collapsed or contracted configuration when the balloon contracts.

[0066] In any of these devices, the expandable member may include an expandable balloon.The first electrode assembly and the second electrode assembly may extend from the elongated body over the expandable member.

[0067] The first plurality of wire loops may include any number of loops (e.g., between 2 and 10 loops, between 2 and 8 loops, between 2 and 5 loops, between 2 and 4 loops, etc.), and the second plurality of wire loops may include any number of loops (which may be equal to the number of loops in the first plurality of loops, e.g., between 2 and 10 loops, between 2 and 8 loops, between 2 and 5 loops, between 2 and 4 loops, etc.).

[0068] Each of the first active regions and each of the second active regions can include one or more flexible bends; in some examples, the angles of the flexible bends can be configured to expand as the balloon expands.

[0069] Each of the first plurality of wire loops and each of the second plurality of wire loops may be coupled to the outer surface of the expandable balloon at one or more points. For example, each of the first plurality of wire loops and each of the second plurality of wire loops may be capable of being slidably coupled to the outer surface of the expandable balloon. In some examples, each of the first active regions and each of the second active regions may be bounded by an insulating region on either side. In some examples, the first electrode assembly and the second electrode assembly are not attached to an expandable member (e.g., a balloon), but may reside adjacent to the expandable member. In any of these examples, the first electrode assembly and the second electrode assembly may be shaped as a radially collapsed or contracted configuration, so that expanding the expandable member (e.g., a balloon) radially expands the electrode assembly, and the contraction of the expandable member allows the first electrode assembly and the second electrode assembly to return to a radially collapsed (or contracted) configuration.

[0070] The first active region of each of the first plurality of wire loops may be spaced apart a fixed distance from the second active region of the wire loops in the second plurality of wire loops.The first electrode assembly and the second electrode assembly may be configured to flexibly conform to a wall of an anatomical structure.

[0071] As described above, in any of these devices, the first electrode assembly and the second electrode assembly may each be formed of a wire having a diameter of, for example, less than 0.2 mm. The first electrode assembly may be configured to have a first polarity, and the second electrode assembly may be configured to have a second polarity.

[0072] Also described herein are devices for delivering pulsed electric fields, which may include: an elongated body; a plurality of arms configured to extend at an angle from the elongated body (e.g., in a deployed state); a first plurality of electrode segments extending between the plurality of arms and forming a first treatment electrode; a second plurality of electrode segments extending between the plurality of arms and forming a second treatment electrode, the second treatment electrode being radially outward of the first treatment electrode (e.g., in the deployed state); and one or more mapping and / or sensing electrodes on the plurality of arms. It should be understood that in some examples, the device is configured to transition from an undeployed state (e.g., an unexpanded configuration) to a deployed state (e.g., an expanded or treatment configuration), while in other examples, the device is configured to already be in a deployed state (e.g., a treatment configuration) and not transition to an undeployed state. The mapping and / or sensing electrodes may be positioned radially outward of the first treatment electrode; in some examples, at least some of the mapping and / or sensing electrodes are positioned radially outward from the second treatment electrode. The structure including the multiple arms, therapy electrodes, and mapping and / or sensing electrodes may be referred to herein as an applicator of the device.

[0073] Any of these devices may include an extension region on the arm. When the device is in a deployed state, the extension region may extend radially outward from all of the treatment electrodes. In some examples, an arm in the plurality of arms may be an insulating hollow member within or through which at least a portion of the first electrode and the second electrode and / or an electrical connector (e.g., a wire) may extend. This configuration may allow for collapse and expansion of the applicator while ensuring that the treatment electrodes maintain a consistent shape and spacing in the expanded or deployed state, which may be particularly helpful in providing consistent and complete treatment.

[0074] The devices described herein may include a deployed state and a retracted (undeployed) configuration, in which the arms extend from the elongated body at an angle, and in which all or some of the arms are retracted into the elongated body and may collapse or bend so that the arms are at least partially within the elongated body; the electrode segments forming the first treatment electrode and the second (or more) treatment electrode may collapse in the undeployed state and may be at least partially within the elongated body. In some examples, the treatment electrodes may be formed by wire segments or other conductor segments that slide relative to the arms to allow for a relatively easy transition between the deployed and undeployed states. In some examples, the device may be configured so that the applicator is always deployed and does not transition to an undeployed state.

[0075] For example, the present invention describes devices for delivering pulsed electric fields, which include: a slender body; a plurality of arms extending from the elongated body at a certain angle; a first plurality of electrode segments extending between the plurality of arms and forming a first treatment electrode; a second plurality of electrode segments extending between the plurality of arms and forming a second treatment electrode, which is radially outward of the first treatment electrode; and one or more (e.g., multiple) mapping and / or sensing electrodes on the plurality of arms.

[0076] In some examples, a device for delivering pulsed electric fields may include: an elongated body; a plurality of arms configured to extend from the elongated body at an angle when the device is in a deployed state; a first plurality of electrode segments extending between the plurality of arms and forming a first treatment electrode; a second plurality of electrode segments extending between the plurality of arms and forming a second treatment electrode, the second treatment electrode being radially outward of the first treatment electrode in the deployed state; and a plurality of mapping electrodes located on an area of ​​each of the plurality of arms extending radially outward from the second treatment electrode in the deployed state, and on an intermediate area of ​​each of the plurality of arms between the first treatment electrode and the second treatment electrode.

[0077] Thus, the plurality of mapping electrodes may include mapping electrodes on an extended region of each of the plurality of arms that extends radially outward from all treatment electrodes in a deployed state. The arms of the plurality of arms may be configured to extend from the elongated body at an angle, for example, between about 20 degrees and about 90 degrees relative to the elongated body in a deployed state. For example, in some embodiments, the arms of the plurality of arms may be configured to transition from a collapsed or undeployed configuration when constrained by, for example, an introducer sheath or other appropriate device during delivery to a treatment site to an extended configuration, wherein each of the plurality of arms extends at an angle relative to the longitudinal axis of the elongated body in a deployed state. The arms of the device described herein may be contained in a sheath or cannula that may be removed during insertion of a delivery catheter; the delivery catheter may maintain the arms in an undeployed configuration until extended out of the delivery catheter. This may make it easier to insert or load the devices into a delivery catheter for use in the body.

[0078] Any of these devices may include a spacer at the distal end region of the elongated body, the spacer being configured to maintain the spacing of each of the plurality of arms within the distal end region of the elongated body. The spacer may be axially movable relative to the distal end region of the elongated body. The elongated body may be configured as a sheath, as described above.

[0079] The first plurality of electrode segments may include a first plurality of arcs extending between the plurality of arms; further, the second plurality of electrode segments may include a second plurality of arcs extending between the plurality of arms. The first plurality of electrode segments may include a first ring or loop forming a first therapy electrode, and the second plurality of electrode segments may include a second ring or loop forming a second therapy electrode.

[0080] Any of these devices may include a central electrode that can be configured as a treatment electrode, a mapping and / or sensing electrode, or both. The central electrode can be integrated with the spacer, or it can be separate from the spacer. In some examples, the device includes a central electrode without a spacer, or a spacer without a central electrode. The central electrode can be configured to extend distally from the distal end of the elongated body.

[0081] Any of the devices described herein may include one or more electromagnetic (EM) sensors coupled to one or more of the plurality of arms, including coupled to or positioned on an extended region of one or more of the plurality of arms. For example, the device may include an EM sensor within an extended region of one or more of the plurality of arms.

[0082] A device as described herein may include a third (or more, e.g., a fourth, fifth, etc.) plurality of electrode segments extending between the plurality of arms and forming a third treatment electrode that is radially outward of the first treatment electrode and the second treatment electrode (e.g., when the device is deployed). The mapping / sensing electrodes may include cylindrical electrodes. In some examples, the mapping / sensing electrodes may be located on the outer surfaces of the plurality of arms. The first plurality of electrode segments and the second plurality of electrode segments may each be formed by a wire having a diameter of 0.2 mm or less.

[0083] In some examples, the device can be configured to apply energy between a first treatment electrode and a second treatment electrode. For example, the first treatment electrode can include an anode and the second treatment electrode can include a cathode, wherein the device is configured to deliver pulsed energy between the first treatment electrode and the second treatment electrode.

[0084] The first therapy electrode and the second therapy electrode can each be 5 cm or longer.

[0085] Also described herein are devices in which the first therapy electrode can form a circumferential collar that is longitudinally spaced apart from the second therapy electrode. The first therapy electrode and the second therapy electrode can have substantially the same radius. In some examples, the first therapy electrode and the second therapy electrode can have different radii.

[0086] For example, a device for delivering pulsed electric fields may include: a slender body; a first plurality of arms, the first plurality of arms being configured to extend from the slender body at a certain angle (e.g., when in a deployed state); a second plurality of arms, the second plurality of arms being configured to extend from the slender body at a certain angle (e.g., in the deployed state); a first plurality of electrode segments, the first plurality of electrode segments extending between the first plurality of arms and forming a first treatment electrode; a second plurality of electrode segments, the second plurality of electrode segments extending between the second plurality of arms and forming a second treatment electrode, the second treatment electrode being axially separated from the first treatment electrode; and a plurality of mapping and / or sensing electrodes.

[0087] In any of these examples, the spacing between the first treatment electrode and the second treatment electrode can be maintained by a plurality of struts extending between the first treatment electrode and the second treatment electrode (even when an expandable / collapsible configuration is used). For example, a device for delivering a pulsed electric field may include: an elongated body; a first plurality of arms configured to extend from the elongated body at an angle; a second plurality of arms configured to extend from the elongated body at an angle; a first plurality of electrode segments extending between the first plurality of arms and forming a first treatment electrode; a second plurality of electrode segments extending between the second plurality of arms and forming a second treatment electrode, the second treatment electrode being axially separated from the first treatment electrode by a plurality of struts; wherein the plurality of struts extend substantially parallel to a distal end region of the elongated body between the first treatment electrode and the second treatment electrode; and a plurality of mapping and / or sensing electrodes on struts among the plurality of struts.

[0088] Any of the devices described herein may include one or more electrodes on the shaft (e.g., just proximate the arm). In particular, these devices may include one or more (e.g., two or more, etc.) sensing electrodes on the shaft of the device (e.g., Figure 3B shown).

[0089] For example, each strut may include one or more mapping / sensing electrodes. Alternatively, only a subset of the struts may include mapping / sensing electrodes. In some examples, the plurality of mapping / sensing electrodes are on the first plurality of arms. A strut in the plurality of struts may extend from at least one of the first plurality of arms and the second plurality of arms. In some examples, the first plurality of arms are rotationally offset from the second plurality of arms.

[0090] As described above, the arms of the first plurality of arms and the second plurality of arms can be configured to extend from the elongated body at an angle, for example, between 20 and 90 degrees relative to the elongated body. In some examples, the arms of the first plurality of arms and the second plurality of arms are configured to transition from a longitudinally extended configuration at least partially within the elongated body to an extended or deployed state, wherein each arm of the first plurality of arms and the second plurality of arms extends from the elongated body at an angle when extending distally from the elongated body.

[0091] Additionally, as described above, any of these devices may include a spacer or guide at the distal end region of the elongated body to maintain spacing of each of the first and second pluralities of arms within the distal end region of the elongated body.

[0092] The first plurality of electrode segments may include a first plurality of arcs extending between the first plurality of arms; further, wherein the second plurality of electrode segments may include a second plurality of arcs extending between the second plurality of arms. The first plurality of electrode segments may include a first loop or ring forming a first therapy electrode, and the second plurality of electrode segments may include a second loop or ring forming a second therapy electrode.

[0093] Any of these devices may include a central electrode. The central electrode may be configured to extend distally from a distal end of the elongated body. The central electrode may include a mapping or / and sensing electrode.

[0094] In some examples, the first plurality of electrode segments and the second plurality of electrode segments are each formed of a wire having a diameter of 0.2 mm or less. The first therapy electrode may include an anode and the second therapy electrode may include a cathode, wherein the device is configured to deliver pulsed energy between the first therapy electrode and the second therapy electrode.

[0095] All methods and apparatus described herein in any combination, including combinations of the various features disclosed with reference to the various examples, are contemplated herein and may be used to achieve the benefits as described herein. BRIEF DESCRIPTION OF THE DRAWINGS

[0096] A better understanding of the features and advantages of these methods and apparatus will be obtained by referring to the following detailed description which sets forth exemplary embodiments and the accompanying drawings of these embodiments, which are as follows:

[0097] Figure 1 One example of a system for delivering high voltage, fast pulses of electrical energy is shown.

[0098] Figure 2A is an example of a device for delivering energy (eg, nanosecond pulses of electrical energy) as a single shot or point-by-point within body vessels.

[0099] Figure 2Bis another example of a device for delivering energy (eg, nanosecond pulsed electrical energy) as a single shot or point-by-point within body vessels.

[0100] Figure 2C is another example of a device for delivering energy (eg, nanosecond pulsed electrical energy) within body vasculature.

[0101] FIG. 3A to FIG. 3B Another example of an applicator including therapy electrodes and sensing / mapping sensors is shown. Figure 3A A distal end view is shown, and Figure 3B A side perspective view is shown.

[0102] FIG. 4A to FIG. 4C An example of an apparatus for delivering pulsed electric fields is shown. Figure 4A An example of a device is shown that includes first and second therapy electrodes and a plurality of mapping and / or sensing electrodes on an extended region of an arm supporting the first and second therapy electrodes. Figure 4B A device for delivering pulsed electric fields is shown which also includes a central electrode. Figure 4C Shown include FIG. 4A to FIG. 4B An example of a device with various features, where one of the arms is shown as transparent.

[0103] Figure 5 is another example of a device for delivering pulsed electric fields that includes a plurality of mapping and / or sensing electrodes.

[0104] Figure 6 is an example of a device for delivering pulsed electrical energy having a multi-layer configuration.

[0105] Figure 7 Examples of animal model tissues are shown, which illustrate the use of FIG. 4A to FIG. 4C The device shown is similar to a device for ablation of discrete areas of tissue.

[0106] Fig. 8A and Figure 8B An example of a wire loop having an active area forming part of an electrode assembly as described herein is shown, showing expansion of the active area of ​​the wire loop at a flexible bend.

[0107] Figure 8C An example of a portion of a device including a small diameter wire electrode assembly formed from a plurality of wire loops having an active region with a flexible bend disposed on an expandable member (eg, a balloon) is shown.

[0108] FIG. 8D to FIG. 8E Shown with Figure 8C An expansion of a device similar to the one shown.

[0109] 9A to 9C Shown with FIG. 8C to FIG. 8E Examples of devices similar to the device shown. Fig.9A An example with a transparent expandable member (eg, a balloon) is shown. Fig. 9B An example with an opaque expandable member is shown. Fig. 9C yes Fig. 9B FIG. 1 is a magnified view of an example of an active area of ​​some of the wire loops of an electrode assembly.

[0110] Fig.10 is a flow chart depicting an example of a method for delivering pulsed electrical therapy to a selected treatment area of ​​a patient. DETAILED DESCRIPTION

[0111] Described herein are systems and methods for treating the body (including body lumens, such as body vessels) with pulsed electric fields using electrodes adapted for insertion into body vessels (such as, for example, arteries, veins, sinuses, and any other vessels within the body as described above). In general, the devices and methods described herein may be positioned inside any body cavity (including, but not limited to, a lumen of the body, such as a tubular body cavity or vessel), against any wall of an organ, and / or in a transition region (e.g., a sinus, ostium, etc.).

[0112] In some cases, body vessels may have irregular or varying shapes. For example, the sinus of a pulmonary vein may transition from a relatively large area or diameter to a relatively small area or diameter. These body vessel surfaces may make it difficult for electrodes to establish effective contact to provide treatment. Various electrodes are described herein that can easily adapt and conform to irregular and / or varying shapes and provide positive contact with body vessels.

[0113] Pulsed electrical therapy can be microsecond pulse therapy or submicrosecond pulse therapy, including nanosecond pulses. For example, nanosecond pulsed electric field therapy can refer to applying a relatively high voltage (in some cases, 5kV or greater) for a relatively short amount of time (in some cases, between about 1 nanosecond and 999ns). These high voltages and short durations produce a pulsed electric field in the area where the voltage is applied. In some cases, nanosecond pulses can cause apoptosis within cellular structures, which can reduce the inflammatory response of the cells.

[0114] Any of the methods described herein can be an ablation method. For example, the methods described herein can be particularly useful for treating cardiac regions, vessels, and the like, such as, but not limited to, the sinuses. In some examples, these methods and apparatus can be used to treat atrial fibrillation and other cardiac conditions, including for ablating cardiac tissue. As will be described in more detail below, any of these methods and apparatus can be used to treat body regions having a tapered or narrowed profile, such as the sinuses of the pulmonary veins. Thus, in some examples, the devices and methods described herein are suitable for use in situations where the shape of the body lumen in which the devices and methods are used has an abruptly changing diameter.

[0115] Alternatively or in addition, these devices and methods can be used to treat the walls of vessels or other lumens that are not necessarily tapered or only slightly tapered. In some examples, these methods and devices can be used to treat the walls of blood vessels or respiratory lumens. For example, these methods and devices can be used to treat arterial stenosis, including in combination with stent implantation or angioplasty procedures. Therefore, in some cases, these methods can be performed within the first 2 to 4 days after angioplasty and / or stent implantation. Untreated smooth muscle cells (SMCs) at the luminal surface in non-endothelialized areas can continue to proliferate at a low rate. The methods and devices described herein can prevent or reduce this situation.

[0116] Figure 1 An example of a system 100 for delivering rapid pulses of electrical energy (also referred to herein by way of example as a sub-microsecond generation system) is shown. Such a system may include an elongated applicator tool 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 tool 102 may include electrodes and may be connected to the housing 105 and the electronic components therein via a cable 137 and a high voltage connector 112. The system 100 may also include a handle 110 and a storage drawer 108. The system 100 may also include a holder (e.g., a holster, a carrier, etc.) (not shown), which may be configured to hold the elongated applicator tool 102. In some examples, the system may be configured for monopolar therapy and may optionally include a dispersive electrode 133 (e.g., a return electrode pad).

[0117] The application tool can be any of the devices for delivering pulsed electric fields in body vessels, as described in detail herein. These devices can generally include an elongated flexible body (collectively referred to herein as an elongated body, a catheter, or an elongated catheter body), at the end of which are one or more electrodes, including electrodes forming one or more rings, which can apply a pulsed electric field to the body. In some cases, the elongated application tool 102 includes one or more imaging sensors, such as one or more cameras and / or optical fibers, at or near the distal end of the elongated application tool 102. The camera (not shown for simplicity) can face forward and / or sideways. The system 100 can be configured to display images (real-time and / or recorded) taken by the elongated application tool 102 to identify the target treatment area and / or zone.

[0118] A human operator may select the number of pulses, amplitude, pulse duration, and frequency information, for example by entering such parameters into a numeric keypad or touch screen of the user interface 104. In some examples, the pulse width may vary. The microcontroller may send signals to pulse control elements within the system 100. In some examples, fiber optic cables are used that allow control signal conduction while also electrically isolating the contents of the metal cabinet (e.g., housing 105) from the outside of the sub-microsecond pulse generation system 100 (e.g., high voltage circuitry). To further electrically isolate the system, the system 100 may be powered by a battery rather than by a wall outlet.

[0119] The elongated applicator tool 102 may be handheld (eg, held by a user) or it may be attached to a movable arm of a robotic system, and its operation may be at least partially automated or fully automated, including computer-controlled operation.

[0120] In any of the devices described herein, the first ring and the second ring may be referred to as electrode rings, or simply "electrodes". In some examples, the first electrode is configured to have one or more segments or rings, and includes an electrically active region ("active region") formed on the one or more segments or rings. The active region is a conductive region configured to contact the target tissue and apply a pulsed electric field therebetween. The active region may be exposed (e.g., may include a conductive surface) and uninsulated compared to other regions of the ring. All of these conductive regions are electrically connected, for example to form a single electrode. Therefore, the active region is typically long and narrow, for example formed by a wire that is a portion of the one or more rings.

[0121] Patent publication WO2022 / 231726, entitled "Circumferential Ablation Devices and Methods," provides an example of a treatment applicator configured to deliver pulsed energy treatment within a body vessel. The methods and devices described herein may be used with any of the variations shown in WO2022 / 231726; for example, see FIG. 2A to FIG. 2C and Figure 3A To Figure 3C.

[0122] FIG. 2A to FIG. 2C Examples of applicators that can be used to deliver pulsed therapy (such as nanosecond pulsed electrical energy therapy) within body vessels are shown. These applicators may include multiple electrode rings that can be selectively activated to apply energy (e.g., bipolar energy) for treating tissue. These devices may also be referred to as conformal ring devices, which can be used to apply energy to tissue within the body. In one non-limiting example, the devices shown herein (including FIG. 2A to FIG. 2C and FIG. 3A to FIG. 3B The device in ( ) can be used for bipolar application of electrical energy to myocardial tissue (such as to treat the pulmonary veins), which includes but is not limited to the sinus, ostium, and medial / lateral wall.

[0123] In some examples, the device includes two electrode rings, an inner ring and an outer ring, which can be used to treat tissue, including (but not limited to) myocardial tissue in the sinus and / or sinus-ostia. In some examples, additional rings can be used. For example, Figure 2A A device comprising three rings is shown, and Figure 2B An example with four rings is shown. Figure 2C An example of two rings with a central electrode is shown. These configurations may also allow for adaptation to patient anatomy and may help achieve both single-shot treatment (e.g., treatment of an entire area (such as the circumference of a vessel) in one treatment, including ablation) and point-by-point treatment (e.g., treatment of small portions of body vessels one at a time, including ablation).

[0124] Figure 2A An example of a configuration of an applicator 260 device having three electrode rings (including an outer ring 261 having a diameter of approximately 30 mm) is shown. The outer electrode can be formed of multiple sub-regions (e.g., petals) that can be electrically coupled together to apply a first polarity; in some examples, each sub-region can be activated independently. Figure 2C A second ring 263 is also included which is smaller than the first ring and is arranged concentrically. Figure 2AIn the embodiment, the second ring has a diameter of about 23 mm and may also be formed of multiple sub-regions that may be electrically coupled to provide the second polarity. In some examples, the multiple sub-regions may also be activated individually. The same device may also include a third ring 265 that is concentrically arranged relative to the second ring and may similarly be formed of multiple sub-regions that may be electrically coupled to provide the first polarity. Figure 2A In one embodiment, the third ring has a diameter of approximately 16 mm. The outer and middle rings may be used to treat larger sinuses and / or ostia, while the second configuration may use the second and third rings for treatment in smaller sinuses and / or ostia. The differences in diameter and / or number of rings may allow the system to select which pair of rings (at which polarity) to designate in order to provide greater accommodation and fit when treating tissue areas of different sizes, such as (but not limited to) sinuses and / or ostia.

[0125] For example, in Figure 2B , the device includes four concentrically arranged rings. The outer electrode (ring 281) can be formed of multiple sub-regions that can be electrically coupled together to apply a first polarity; in some examples, each sub-region can be independently activated. The second ring 283 is arranged concentrically relative to the first ring and can also be formed of multiple sub-regions that can be electrically coupled to provide a second polarity or can be independently activated (energized). A third ring 285 of smaller circumference is arranged concentrically relative to the second ring and can similarly be formed of multiple sub-regions that can be electrically coupled to provide a first polarity. Finally, a fourth electrode (ring 287) of even smaller circumference is arranged concentrically relative to the third ring.

[0126] like Figure 2C As shown, any of these devices may provide a central small (eg, point) electrode. Figure 2C Two concentrically arranged electrode rings are shown. The first ring electrode 291 can be formed of multiple sub-region electrodes, each of which is formed of a wire having an exposed electrically active area. As in any of these examples, in some configurations, each sub-region can be controlled individually and / or they can all be electrically coupled together to form a single electrode. The second ring electrode 293 is arranged concentrically relative to the first ring electrode and can be formed of multiple sub-regions like the first ring electrode. Finally, Figure 2C The example shown may also include a single center electrode 495 that may be configured to apply a polarity opposite to the polarity applied to the larger outer ring (or a sub-region of the outer ring) or the inner ring (or a sub-region of the inner ring).

[0127] Any of the applicators described herein may include additional electrodes to allow visualization of the device in conjunction with the mapping system. For example, FIG. 3A to FIG. 3B(adapted from WO2023 / 231726, incorporated herein by reference) shows an example of a device including treatment electrodes 311, 321 and mapping electrodes 350, 350'. Figure 3A In the embodiment of the present invention, ten separate mapping electrodes 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 are positioned on the distal side of the applicator facing outward. The mapping electrodes may also be referred to as sensing electrodes. As described above, the applicator 300 may be configured to deliver nanosecond pulsed energy therapy. The applicator 300 includes an inner proximal ring 320 and an outer distal ring 310. The inner ring 320 and the outer ring 310 each include five petals formed by a certain length of wire forming treatment electrodes 311, 321. In addition, the applicator 300 includes five arms 330 that couple the inner ring and the outer ring (e.g., flexibly) to the elongated catheter body 340. As described above, the inner ring and the outer ring may have more petals (e.g., more treatment electrodes) and / or may have fewer petals.

[0128] The sensing or mapping electrodes are typically smaller than the treatment electrodes, which in this example are elongated wires of a certain length. For example, the length and / or width of the sensing or mapping electrodes may be 5 mm or less (e.g., may have a maximum dimension of 5 mm or less, 4.5 mm or less, 4 mm or less, 3.5 mm or less, 3 mm or less, 2.5 mm or less, 2 mm or less, 1.5 mm or less, 1 mm or less, etc.). The mapping electrodes may be electrically isolated from the treatment electrodes. Figure 3A The sensing or mapping electrodes 4350, 4350' are formed of strips or hoops of conductive material (e.g., metal) that are crimped or otherwise coupled to insulating material on the arm 330 of the device. Some examples of insulating materials or coatings include polyimide, PET, etc. Each sensing or mapping electrode may include a lead (e.g., a wire) extending from the sensing or mapping electrode through the catheter and reaching a coupling site (not shown) to couple to a sensing or reading subassembly and / or to a separate mapping system or subsystem. The sensing or mapping electrodes may be electrically separated and isolated from the treatment electrodes.

[0129] In operation, sensing and / or mapping electrodes (e.g., sensing / mapping electrodes) can be used to isolate the position of the applicator relative to tissue or relative to a map of the tissue. For example, sensing / mapping electrodes 1, 3, 5, 7, and 9 can provide the outline of an outer ring, while sensing / mapping electrodes 2, 4, 6, 8, and 10 can provide the outline of an inner ring. Combinations of sensing / mapping electrodes (e.g., 1-2, 3-4, 5-6, 7-8, 9-10 or other combinations) can also or alternatively be used to improve signal acquisition and / or can be used for more reliable tissue contact. In some examples, the sensing / mapping electrodes can be used for position detection without the need for tissue contact.

[0130] In general, sensing / mapping electrodes can be used (instead of or in addition to treatment electrodes) to monitor the progress of treatment. For example, sensing / mapping electrodes can be used to determine whether the target tissue has changed one or more electrical properties and / or electrical activity. For example, sensing / mapping electrodes can be used to determine or monitor electrical activity on or near the target tissue before and / or during the application of pulsed (e.g., nanosecond pulsed) energy from the treatment electrode. Using the methods described herein (e.g., by applying non-thermal treatment such as nanosecond pulsed electrical energy) to ablate tissue, it is expected that the electrical activity of the underlying target (e.g., heart) tissue will be reduced. In general, the methods described herein can apply, for example, sub-microsecond (e.g., nanosecond) pulses between 0.1 (Hz) and 100,000 Hz per second. Even at faster (e.g., kHz) frequencies, nanosecond pulses can provide relatively long periods of time during which no energy is applied to the tissue, during which time the sensing / mapping electrodes can detect electrical activity on the tissue. In some examples, the sensing / mapping electrodes can be used to determine the impedance of the underlying tissue and / or changes in impedance over time.

[0131] The device may also include one or more magnetic sensors 342 (e.g., magnetic coils, rods, etc.). Figure 3A In the example of , the magnetic sensor is attached to the distal portion of the catheter body 340 and is centrally located relative to the treatment electrode. This can increase the accuracy of the catheter's position.

[0132] Figure 3B A side view of the applicator 300 is shown. The inner ring 320, outer ring 310, and arm 330 are shown coupled to the elongated body 340. In this example, one or more (e.g., two, 11, 12) additional sensing / mapping electrodes may be positioned on the shaft of the elongated body 340 and may be used in conjunction with one or more of the other sensing / mapping electrodes mentioned above.

[0133] FIG. 2A to FIG. 2C and FIG. 3A to FIG. 3B The devices shown in may include sensing and / or mapping electrodes. In addition, these examples may be modified as described herein. For example, the sensing and / or mapping electrodes may be coupled between the rings (e.g., on portions of the rings extending radially inward or between electrode active areas), and / or coupled to one or more extensions extending radially outward from the electrode active areas.

[0134] Any of these devices can be used as a distal portion of an elongated body (such as a catheter) and can be used to treat, for example, atrial fibrillation. Treatment of atrial fibrillation can include various target sites, including, but not limited to: pulmonary vein (PV) sinuses, PV ostia, and heart wall muscle / tissue. As described herein, these devices can be used to treat large areas (e.g., a single application of sub-microsecond pulsed energy), such as for treating pulmonary vein sinuses / ostia of varying sizes, and / or have the ability to provide point-by-point tissue treatment (e.g., ablation) throughout the cardiac anatomy. These devices can also be used to apply sub-microsecond treatments in other parts of the human body. For example, a larger diameter outer ring can be used for a single treatment of the sinuses and ostia, while a smaller inner ring can be used for point-by-point ablation of target tissue. Due to the conformability and adjustability of these configurations, treatment can be achieved more effectively while also being able to adjust / conform to anatomical structures of varying sizes.

[0135] In some implementations, the first and second rings (or any additional rings) of the applicator 260, 280, or 290 can be approximately coplanar. This coplanar arrangement can enable the electrodes (e.g., the first and second rings) to provide better contact with planar tissue and / or tissue shaped similar to the sinuses of the pulmonary veins. In some examples, the electrodes can even have a "funnel" configuration facing in the opposite direction of the sinuses of the pulmonary veins.

[0136] Any of the applicators described herein are configured to deliver therapy (such as nanosecond pulsed energy therapy) within a body vessel. The body vessel can be any feasible vessel, including but not limited to the sinus of a pulmonary vein or the pulmonary vein itself. In some examples, the applicator can include a proximal ring, a distal ring, and an elongated catheter body. The applicator can include three rings, and in some examples, the applicator can include any feasible number of rings, such as two (see Figure 2C , FIG. 4A to FIG. 4B ), four ( Figure 2B ) etc. The term "distal" may generally refer to the portion closest to the distal end of the applicator (and closest to the treatment tissue / surface), and the term "proximal" may generally refer to the portion relatively further away from the distal end of the applicator and the treatment tissue / surface. However, those skilled in the art will recognize that other terms may be used to identify and distinguish features of the applicator (including the proximal ring and the distal ring). For example, the proximal ring and the distal ring may be referred to as the first ring and the second ring.

[0137] The rings (e.g., the proximal ring and the distal ring) can be formed of any conformable material. In at least one example, the proximal ring and the distal ring can be formed of nitinol (e.g., nickel titanium). However, any other feasible material can be used, such as stainless steel. As shown in the exemplary applicator, the proximal ring can have a larger diameter than the distal ring. In other examples, the proximal ring can have a smaller diameter than the distal ring.

[0138] The proximal and distal rings (and any intermediate rings) can be used as circular electrodes to deliver, for example, nanosecond pulsed energy to a selected treatment area. In this example, the entire outer periphery of each of the rings can be an active area (e.g., electrically continuous), so that the outer periphery of the rings, rather than the inner arms (which can be insulated), forms the active area for applying electrical energy. In some examples, the proximal and distal rings can be retracted into the catheter body (not shown). The applicator can then be positioned in the treatment area. After confirming the placement of the applicator, the proximal and distal rings can then be deployed from the catheter.

[0139] In some examples, the ring electrode is not deployed from the catheter body, but can be contained in the delivery catheter together with the catheter body; once at or near the target treatment position in the body, the distal end of the device (e.g., the ring electrode in this example) can be deployed outside the delivery catheter. For example, the entire device (including the catheter body and the electrode) can be inserted into the proximal end of the delivery catheter (also referred to as the guide sheath in this article). The guide sheath can be already in the patient's body so that the distal end of the sheath is positioned near the target area (e.g., in some examples, at or near the left atrium or right atrium). The elongated catheter body and the electrode (e.g., the ring electrode) can be inserted into the proximal valve of the guide sheath using an introducer (e.g., a plastic tube), and the device can slide distally in the sheath. In some examples, the delivery catheter holding the distal end (e.g., the ring electrode) can be advanced to the target tissue and then kept in place while the distal end is driven out of the delivery catheter.

[0140] The proximal ring may include two or more petals. FIG. 2A to FIG. 2C The proximal ring may be divided into two or more semicircular portions joined to the arms (see e.g. FIG. 4A to FIG. 4B ). In some examples, the arm can be insulated. Similarly, the distal ring can include two petals joined to the arm. In other examples, the proximal ring and the distal ring can include any number of petals and arms. In some cases, increasing the number of petals can increase the flexibility of the proximal ring and the distal ring, so that they can more easily conform to the different shapes of the body's vessels, thereby allowing the electrodes of the ring to be well juxtaposed with the target tissue. In some examples, the arm can be formed of nitinol or any other feasible material. The arm can flexibly couple the proximal ring and the distal ring to the elongated catheter body. Note that in any of the devices described herein, the entire device can be referred to as a "catheter", and the elongated, generally flexible main body portion extending from the distal end can be referred to as a catheter body, an axis, or an axis of the elongated body. The electrodes extending from the distal end of the elongated catheter body can move relative to the distal end of the elongated catheter body, or they can be fixed relative to the distal end.

[0141] In some examples, the applicator may be comprised of an elongated catheter body and a proximal handle (such as Figure 1 The applicator may be guided by a guide wire (not shown for simplicity) and / or by using fluoroscopic equipment. The apparatus described herein (e.g., an applicator) may include a central lumen (e.g., extending through the elongated catheter body) that may allow the apparatus to be operated over a guide wire. Alternatively, a quick-change lumen may be present on one side of the distal end of the applicator.

[0142] The distal end of the device can be positioned in the approximate area of ​​tissue to be treated (target tissue area), and the ring electrodes (e.g., proximal ring and distal ring) can be expanded outward. The proximal ring and distal ring (and any intermediate rings) can be flexibly coupled to and exposed from the elongated catheter body and juxtaposed with the body vessel. The precise position of the applicator including the ring electrodes can be verified, and / or the device can be repositioned before applying energy.

[0143] Then, nanosecond pulse energy treatment of body vessels can be started. In some examples, system 100 and applicator can be configured for bipolar operation, for example, between proximal ring and distal ring. In some examples, the proximal ring can be referred to as cathode, and the distal ring can be referred to as anode (or vice versa). In other examples, the proximal ring can be associated with a signal having a negative signal, and the distal ring can be associated with a signal having a positive signal. The proximal ring and the distal ring can be used as electrodes to deliver nanosecond pulse energy. Electrodes carrying opposite polarity signals can enable an electric field associated with pulse treatment to be generated between electrodes. In some examples, system 100 (including applicator) can be configured for monopolar operation. For example, the proximal ring and the distal ring can be electrically coupled to each other, and a signal can be applied between the proximal ring and the distal ring and a return electrode (for example, another conductor, such as a part of an elongated catheter body, or a conductive pad or electrode) that can be contacted with a patient.

[0144] After delivering the nanosecond pulsed energy therapy, the applicator may be moved to another area of ​​the body vasculature or removed from the patient.

[0145] Any of the devices described herein can also be elastically resilient and configured for use in expandable and contractible body regions, such as during diastole / systole, respiration, etc. For example, as just described, the electrodes can be made into rings (or partial rings) that are flexibly coupled to the distal end region of the catheter body. The flexible coupling can be by a wire or other member that allows the ring to bend with the movement of the tissue while remaining in place on the tissue. Any of the devices described herein can be configured to treat the sidewalls of the lumen and / or can be configured to treat the forward (distal) region of the tissue, as described in more detail below.

[0146] Point-by-point treatment

[0147] The devices described herein can be used for point-by-point treatment. For example, any of these devices may include a smaller electrode (e.g., a central electrode) or a sub-portion of an applicator area. For example, the devices described herein can be used to perform cardiac ablations to address various problems, such as atrial fibrillation, ventricular tachycardia, ventricular wall thickening, etc., and to perform ablations in other organs, such as the esophagus (e.g., Barrett's esophagus), the bronchi (e.g., chronic bronchitis, asthma, etc.), etc. The same device can be configured, for example, to apply a larger treatment area using the entire applicator area, and a sub-portion of the applicator area can be used to apply a smaller treatment area suitable for point-by-point treatment.

[0148] The devices described herein can be configured to produce a treatment area (e.g., in some examples, an ablation area) of approximately 5 mm to 15 mm. In some cases, a larger treatment area may not be required or recommended. For example, ablating too much of the proximal wall or top of the left atrium (LA) of the heart may result in loss of myocardial function or interruption of the proper pathway for propagation of cardiac electrical impulses. The devices described herein can limit the "footprint" of ablation to, for example, approximately 5 mm to 15 mm, depending on the distance between the electrodes, and can produce an electric field strong enough to achieve a transmural effect.

[0149] In general, the devices described herein may have radially separated active regions (and in some examples, central electrodes). These active regions may be formed by exposed (uninsulated) flexible wires along all or part of a circumferentially extending segment forming a "petal" or annular shape. The applicator may be of any suitable size; for example, the length of the active region of each petal may be between 5 mm and 3 cm (e.g., between 7 mm and 1.5 cm, between 8 mm and 12 mm, etc.), and the diameter of the (optional) central electrode may be between 0.5 mm and 5 mm (e.g., between 1 mm and 3 mm, etc.). In an example with 3 petals, each of the curved active regions ("petals") may extend approximately 120 degrees around a central region including an optional central electrode. In some examples, the central electrode (if present) may be configured to operate at a different polarity than one or more (or all) of the radially curved active regions so as to apply energy in a bipolar manner (between the central electrode and one or more of the active regions). In some examples, a center electrode is not included or used, and bipolar energy may be applied between any two of the curved active regions.

[0150] Any of these devices may be used as a distal portion of a device or device that includes an elongated body (e.g., a catheter) that can be used for treatment within a lumen of the body, such as, but not limited to, treatment of atrial fibrillation, treatment of ventricular tachycardia, or other heart-related ablations. For example, these devices can be used to apply nanosecond pulsed electric fields to almost any part of the human body. For example, these devices can be used in some embodiments to apply other types of energy, such as RF or microsecond pulsed energy. These applicators can be part of a catheter used during minimally invasive surgery or as part of a device used during surgery (e.g., cardiac surgery). In some cases, if necessary, the method of using the device can be performed as a concomitant procedure, and the device may not be catheter-based.

[0151] In either of these devices, the distance between the electrodes may be constant or variable, which may determine the strength of the pulsed field at each given voltage, and therefore the size of the treatment area.

[0152] Any of these devices and methods can be used in conjunction with a cardiac mapping and navigation system. For example, any of these devices and methods can be part of an ablation method for treating a cardiac region including, but not limited to, a pulmonary vein (or sinus associated with a pulmonary vein), and can include utilizing mapping (such as 3D electroanatomical mapping / mapping of the tissue in question) to coordinate the location of the applicator's energy application (e.g., sub-microsecond pulsed energy application) electrodes.

[0153] As mentioned, the device may include one or more sensors, including electrical sensors (e.g., sensing electrodes) and / or imaging sensors, etc. The device may integrate data from these one or more sensors with one or more mapping diagrams of the tissue to be treated. These electroanatomical mapping diagrams may be generated by a separate mapping system, including commercially available mapping systems, or the device described herein may include a mapping system or subsystem integrated into the device. In some examples, the sensors are configured as electrodes that can be used as sensors for a mapping (e.g., 3D electroanatomical mapping) system or subsystem and are used in conjunction with one or more patches that can be applied to a patient and connected to the mapping system / subsystem.

[0154] Sensors (including sensing electrodes) can be used for navigation other than or instead of mapping. Any reference to mapping or mapping / sensing electrodes included herein can also refer to navigation (e.g., mapping / navigation) and is intended to cover such navigation. Thus, these devices and methods can include using sensed electrical activity to generate a mapping diagram of tissue such as the heart, and the sensing electrodes can also be used to assist in navigating an instrument to a treatment location.

[0155] FIG. 4A to FIG. 4C An example of a device for delivering pulsed electric fields according to the present disclosure is shown, which may include mapping ("sensing") electrodes in addition to treatment electrodes. The devices described herein may be particularly well-suited to providing improved sensing (e.g., mapping, navigation, etc.) using multiple electrodes across a relatively large area while maintaining a small footprint. In particular, these devices may provide sensing electrodes on either side of the treatment electrodes (outer ring or segments and inner ring or segments). The devices described herein may include an elongate body 403, the distal end of which is shown in Figure 4A FIG. The elongate body may be an elongate catheter body. In some examples, the elongate body may be part of an outer delivery catheter. The applicator 400 may be configured to be held entirely or partially within the elongate body in a non-deployed state (not shown), which has a low profile to allow it to be easily inserted through the body and expanded by extending out of or retracting into the elongate catheter body. For example, the applicator may include a plurality of arms 430, 430', 430", which are configured to extend at an angle from the elongate body when in the deployed state. The device also includes a first plurality of electrode segments 411, 411', 411", which extend between the plurality of arms and form a first treatment electrode 410. In some examples, the first treatment electrode is also referred to as an "inner electrode" or "inner annular electrode" (when the applicator is deployed). Each electrode segment of the first plurality of electrode segments forms an arc, and the arcs together form a ring that can be approximately transverse to FIG. 4A to FIG. 4CThe device also includes a second plurality of electrode segments 421, 421', 421", which extend, for example, in an arc between the plurality of arms and form a second treatment electrode 420, which is radially outside the first treatment electrode when the applicator is expanded or deployed. In some examples, the second treatment electrode is referred to as an "outer electrode" or "outer ring electrode". The device also includes a plurality of mapping and / or sensing electrodes 450, 450' on the plurality of arms. The mapping / sensing electrode may be positioned radially outside the first treatment electrode (e.g., between the first treatment electrode and the second treatment electrode), as shown. In some examples, the second plurality of electrode segments may form a ring that may be approximately transverse to the long axis of the elongated body and may be radially inside the first treatment electrode when the applicator is deployed.

[0156] exist FIG. 4A to FIG. 4B In the embodiment of the present invention, the arms of the applicator of the device may include extension areas 431, 431', 431". FIG. 4A to FIG. 4C As shown in , the arm of the applicator of the device can be a hollow (or solid) cylinder that can be pre-bent or bent and / or biased to bend / bend at an angle to the long axis of the slender body 403 when extending relative to the distal opening of the slender body. In some examples, the arm can accommodate a portion of an electrode segment that forms a treatment electrode. The multiple electrode segments that form the first treatment electrode (and the multiple electrode segments that form the second treatment electrode) can each be individually coupled to an electrical connector (e.g., a wire, trace, etc.) or can be electrically coupled together. Each electrode of the corresponding multiple electrode segments can be formed as a wire electrode, for example, as a portion of a wire electrode that is uninsulated along all or a portion of its length.

[0157] As shown, when deployed, the extended region of the arm of the device can extend radially outward beyond the outer (e.g., second) treatment electrode. The extended region can provide support or contact and additional space for one or more sensing (e.g., mapping) electrodes. FIG. 4A to FIG. 4C In the example shown, mapping and / or sensing electrodes are positioned between the first and second therapy electrode rings, on the plurality of arms, and on extended regions of the arms, radially outward from the outer (when deployed) therapy electrode.

[0158] The device may also include one or more central electrodes. Figure 4B As shown, the device may include a central electrode 491 that extends distally from the elongated body when the applicator is deployed so that the arms and the first and second electrodes (or, in some implementations, any additional electrodes that form an electrode ring similar to the first and second electrodes) surround the central electrode. The central electrode can be a treatment electrode. In some examples, the central electrode can be a mapping / sensing electrode or both a mapping / sensing electrode and a treatment electrode.

[0159] Figure 4C Shows that there is FIG. 4A to FIG. 4B An example of a device with features of , but in which one of the arms 430' is shown as transparent to show an example of internal components, including one or more electrical connectors (e.g., wires) 483 connected to and / or forming a first electrode segment 411 of a first treatment electrode 410, one or more electrical connectors (e.g., wires) 483 connected to and / or forming a second electrode segment 421 of a second treatment electrode 420, and one or more wires 485 coupled to mapping electrodes 450, 450'. For example, each of the corresponding plurality of electrode segments may be coupled to or may be formed from an exposed or uninsulated portion of a wire 483, 483'. In general, the arms 430, 430, 430" can be insulated and / or formed of a polymeric material. The arms may include one or more openings through which internal wires forming treatment electrodes may extend. The wires within the arms may be configured to slide at least slightly within the arms so that the wires may move longitudinally relative to each other to prevent breakage and relieve mechanical stress when the arms transition between a delivery configuration and a deployed state, in which the wires may, for example, remain straight within the elongated body 403, and in which the arms are angled relative to the elongated body.

[0160] In the deployed state, the arm can extend at an angle, for example, between about 20 and 90 degrees relative to the long axis of the elongated body at the distal end region. FIG. 4A to FIG. 4C In the embodiment shown, the arms (three arms are shown) extend at an angle of about 85 degrees relative to the long axis. In some examples, the angle may be between 30 and 90 degrees, between 40 and 90 degrees, between 45 and 90 degrees, etc. In this example, all three arms are deployed at approximately the same angle; in some examples, the arms may be configured to bend / deploy to different angles, which can "steer" the face of the applicator in a desired direction. FIG. 4A to FIG. 4C As described above, in some examples, fewer (e.g., two arms) or more than three arms (e.g., four arms, five arms, six arms, etc.) may be used. In some embodiments, any of these devices may also include one or more spacers or guides 481 that may be within the distal end region of the elongated body and that may maintain the spacing between the arms and that may coordinate the movement of the arms, including the insertion of the arms into the distal end region of the elongated body and / or the withdrawal of the arms from the distal end region of the elongated body. FIG. 4B to FIG. 4CAs shown, the guide / spacer may include a central region coupled or engaged with a central electrode 491. The central electrode 491 may be configured to form a column of additional mapping, sensing and / or treatment electrodes. The guide / spacer may also have one or more channels for each arm, thereby preventing them from radially shifting within the elongated body while still allowing longitudinal movement.

[0161] The extension region 431, 431', 431' of each arm can be configured to extend beyond the outer radius of the treatment electrode and can allow for a larger mapping area. In general, the use of dedicated tubular arms through which connectors (e.g., wires) and / or additional sensors (e.g., EM sensors) can be positioned can be particularly beneficial and can protect the applicator, insulate the wires, and increase the overall robustness of the device.

[0162] In any of these examples, the device may include at least one sensor (eg, electromagnetic sensor 487) within the arm (including, for example, within an extended region 431, 431', 431" of one or more (eg, all) of the arms).

[0163] The applicator described herein can be configured for bipolar operation. Pulse energy can be transmitted, for example, between the first ring and the second ring. Therefore, the first ring 410 can be associated with a signal having a first polarity (e.g., a positive signal), and the second ring 420 can be associated with a signal having a second polarity (e.g., a negative signal). In other examples, the first ring 410 can be associated with a signal having a negative signal, and the second ring 420 can be associated with a signal having a positive signal. In another example, the applicator 400 can be configured for monopolar operation. For example, the first ring 410 and the second ring 420 can be electrically coupled together, and a return electrode (e.g., on the elongated catheter body 403 or a conductive pad) can be used.

[0164] The administration devices described herein may also be configured to include more than two treatment electrodes, as described above. For example, Figure 5 An example of a device configured as an applicator having a FIG. 4A to FIG. 4C Similar three arms and a mapping and / or sensing electrode coupled to each arm 530, 530', 530" and three treatment electrodes 510, 520, 540 forming an inner ring, a middle ring and an outer ring of electrodes, respectively. As described above, each treatment electrode can be formed by a plurality of electrode segments 511, 521, 541. In this configuration, the mapping and / or sensing electrodes 550, 550', 550" are positioned radially inwardly on each arm between the inner ring 510 and the middle ring 520, between the middle ring 520 and the outer ring 540, and radially outwardly from the outer ring 540, for example, on the extended arm region 531. Figure 5The example shown may also include (optionally) a center electrode 591 and / or a spacer / guide 581 .

[0165] FIG. 4A to FIG. 4C and Figure 5 The example shown in is shown as a single layer (single layer, even funnel-shaped) ablation device, which includes, for example, six or more mapping electrodes or sensors for detecting intracardiac electrograms (EGMs). In some examples, the device may alternatively be configured to include multiple layers, such as Figure 6 The two-layer applicator shown in . The two-layer structure may include a plurality of treatment electrodes that are arranged to be longitudinally offset from each other, but have the same or nearly the same (e.g., not significantly different) radius from each other. The multi-layer device may include a plurality of struts (e.g., transverse struts or connecting struts) that extend between a first (e.g., upper or more distal) treatment electrode and a second (lower or more proximal) treatment electrode. Figure 6 Also shown are example locations of a set or subset of sensing electrodes (e.g., mapping electrodes). The sensing electrodes may be located in a variety of locations, including around the perimeter of the device. Figure 6 The devices shown in the examples allow for more accurate 3D rendering because they include a plurality of mapping electrodes 650, 650', 650", 650"', 650"", 650""' on the lateral-facing side of the applicator (e.g., on struts 635, 635', 635", 635"', 635"", 635""') and may also include a plurality of sensing / mapping electrodes 651, 651', for example, on a first (e.g., upper) set of arms.

[0166] In some examples, struts 635, 635', 635", 635"', 635"", 635""' extend from a first (e.g., upper) set of arms 630, 630', 630" and / or a second (e.g., lower) set of arms 631, 631', 631". Multiple electrode segments 614, 614', 614", 614"', 614"", 614""' forming distal treatment electrodes and multiple electrode segments 612, 612', 612", 612"', 612"", 612""' forming proximal treatment electrodes may be coupled at either end of corresponding connecting struts.

[0167] For example, Figure 6The device for delivering pulsed electric fields shown in includes a slender body 603, which may be the same or similar to the slender body described above, and in some examples may be configured so that an applicator (including electrodes) can be at least partially withdrawn into a distal end region of the slender body for delivery or navigation to the heart or other target body region. The device may also include a first plurality of arms 630, 630', 630", which are configured to extend from the slender body at a certain angle when deployed; and a second plurality of arms 631, 631', 631", which are configured to extend from the slender body at a certain angle when deployed. In some examples, the upper arm may be rotationally offset from the lower arm, such as Figure 6 As shown. The device may also include a first plurality of electrode segments 614, 614', 614", 614"', 614"", 614""', which extend between the first plurality of arms 630, 630', 630" and form the first treatment electrode 610; and a second plurality of electrode segments 612, 612', 612", 612"', 612"", 612""', which extend between the second plurality of arms 631, 631', 631" and form the second treatment electrode 620, which is axially separated (e.g., axially spaced apart) from the first treatment electrode by a plurality of struts. The plurality of struts may extend between the first treatment electrode and the second treatment electrode, for example, parallel or substantially parallel (e.g., within + / - 1°, 2°, 3°, 4°, 5°, 6°, 7°, 8°, 9°, 10°, etc.) at the distal end region of the slender body. As mentioned, the device may include a plurality of mapping and / or sensing electrodes; in some examples, these mapping electrodes may be located on a strut in the plurality of struts. Figure 6 In the example shown, the device also includes a central electrode 691 that can be configured, for example, for sensing (e.g., a mapping electrode), and a central electrode 692 that can be integrally formed with the device and can be used with the device. Figure 5 A spacer (not shown) similar to the spacer shown is shown. Alternatively, the center electrode 691 can be used for treatment or therapeutic applications (eg, in combination with a first therapy electrode and a second therapy electrode).

[0168] Figure 6 The struts 635 in the example can stabilize the spacing between the therapy electrodes 610, 620 and / or the shape of these therapy electrodes.

[0169] In operation, the above-described devices may be used to ablate relatively large areas of tissue (eg, the heart). Figure 7 Shows the use of FIG. 4A to FIG. 4C , Figure 5 or Figure 6 Examples of tissue ablation using devices similar to those devices shown in the examples and described above. For example, Figure 7An example of porcine heart tissue that has been treated by applying energy as described herein to form ablation zones is shown. Three exemplary ablation zones 742, 742', 742". Energy is applied to the tissue surface and is applied by bipolar application between the central electrode and one or more of the circumferential treatment electrodes, or between two (or more) of the circumferential treatment electrodes.

[0170] Any of these devices may be configured for magnetic sensing or electrical property (e.g., impedance-based) sensing, or both. As described above, sensing may be used for navigation and / or mapping. In some examples, the applicator may be coupled to a third-party mapping and / or navigation system (e.g., Carto) by, for example, providing input directly or indirectly to the mapping system from the sensing / mapping electrodes. TM System, Navx TM Systems, etc.). The applicators described herein can be used in conjunction with a separate mapping catheter. For example, a mapping catheter and system can be used to map tissue, which can generate a map or model of tissue (such as cardiac tissue), including, in particular, a target area to be treated, and any of the applicators described herein can be introduced and one or more sensors (including electrodes) can be used to position the applicator on the map or model of the tissue. The device can display an image of the map or model, and can simultaneously show the position of the applicator on the image of the map or model to help guide / navigate the user (e.g., a physician, surgeon, etc.) to treat the target tissue. Alternatively, the applicators described herein can be used for both mapping and ablation. In some examples, the device described herein may include a mapping system or subsystem integrated into the device.

[0171] For example, the device may include an applicator similar to those described above, the applicator including a plurality of treatment electrodes and a plurality of sensing / mapping electrodes. The applicator may be coupled to a nanosecond pulsed energy therapy system, which may also include the apparatus described above (e.g., Figure 1 The system may be separate from a mapping system and / or output, which may include one or more displays and may show a map of the tissue, including the position of the applicator based on input from one or more sensing / mapping electrodes (or other mapping sensors) on the applicator. In some examples, the device may include a pulsed energy therapy system and output, which may be used in conjunction with a separate mapping system / subsystem. Alternatively, in some examples, the mapping system / subsystem may be included as part of the device. In any of these devices, a separate mapping catheter may be coupled to the mapping system / subsystem.

[0172] Wire-based bipolar electrodes for nanosecond pulsed energy application

[0173] Any of the methods and apparatus described herein may be used for bipolar sub-microsecond (e.g., nanosecond) pulse application using electrodes formed from thin (low-profile) wires. These low-profile wires may have a maximum diameter of 0.015" (e.g., 0.38 mm) or less (e.g., 0.35 mm, 0.30 mm, 0.25 mm, 0.20 mm, 0.15 mm, 0.13 mm, 0.12 mm, 0.10 mm, etc. or less). These wires may be formed from any conductive material. The lower profile wires are particularly suitable for emitting the electromagnetic fields described herein. Typically, such low-profile wires have been avoided for use with systems that generate thermal energy because the thinner profile wires may limit the ablation area and may be more susceptible to fracture.

[0174] For example, most energy-based treatment devices, such as radiofrequency (RF) devices, employ electrodes with diameters of approximately 2 mm to 3 mm or more. For example, RF thermal ablation relies on two types of heating: resistive heating and conductive heating. Tissue in direct contact with the electrode is heated via resistive heating based on the voltage applied to the electrode and the electrode material and the impedance between the electrode and the tissue. Tissue away from the electrode can be heated due to conductive heating directly from the electrode or by conducting heat from an already "hot" portion of the tissue to a "colder" area. The size of the electrode does matter in this case because a larger electrode covers a larger area of ​​the tissue, thereby increasing the "direct" conductive heat transfer between the electrode and the tissue. In addition, if multiple electrodes are used (e.g., a bipolar RF system), the larger size of the electrodes reduces the distance between them, thereby reducing the volume of tissue that needs to be heated by "indirect" conductive heat transfer. Even for some applications involving pulsed signals (e.g., millisecond, microsecond pulses), more massive electrodes are considered advantageous because the location of the highest energy concentration is at the electrode, and the field generated by a typical 2kV to 3kV (e.g., approximately the voltage used by most microsecond pulse devices) is not high enough to perform treatment. Therefore, most microsecond-based devices typically require repositioning of electrodes to produce a continuous treatment zone.

[0175] As opposed to more bulky tubular electrodes used, for example, with RF ablation, using such low-profile guidewires of the present disclosure allows the devices described herein to have a relatively smaller cross-sectional profile. This can allow any of these devices to be retracted into, for example, the working channel of a bronchoscope / gastroscope or the lumen of a delivery sheath for cardiac applications, which can simplify and / or enable specific procedures.

[0176] Even if the electrodes are composed of small diameter (e.g., 0.005" to 0.015" or less) wires, the bipolar sub-microsecond (e.g., nanosecond) pulsed energy described herein can be applied at voltages high enough to produce a therapeutic field (e.g., 12kV to 15kV or greater). It has been surprisingly found that tests using such small diameter wires are very effective for tissue ablation and do not require repositioning to ablate tissue between them.

[0177] As described above, in any of these devices, the electrode assembly may include a plurality of petals formed by wire loops that are arranged around an expandable member (such as a balloon, an expandable frame, etc.), or these wire loops themselves are expandable or part of an expandable frame. Each petal may include an active region of the electrode assembly. The wire loops forming the petals may include an insulating leg region on either side of the active region; the leg region may extend generally longitudinally. The legs may also be referred to as ribs herein. The active region of each respective petal may be arranged at least partially circumferentially around the expandable member so that all active regions of the electrode assembly may surround (or at least partially surround) the expandable member together. Each active region may be flexible and configured to change its shape so that when the expandable member expands (and / or contracts), the active region may increase (and / or decrease) its circumference so that the radial circumference formed by the active region of the electrode assembly increases and / or decreases as the expandable member expands or contracts. This radial expansion may allow treatment of anatomical structures (e.g., lumens, walls, etc.) of various sizes. As mentioned, in any of these examples, the active regions can each include a hinge region. In some examples, the hinge region can be formed as a flexible bend (or bends) in the active region of the ring of the electrode assembly.

[0178] For example, Fig. 8A and Figure 8B A single ring (or petal) 800 of an electrode assembly is shown; Fig. 8A The ring is shown in an unexpanded configuration, and Figure 8B The same ring is shown in an expanded configuration. Fig. 8A In the embodiment of the present invention, the ring includes an active region 822, which is an exposed (uninsulated) wire extending between two insulating regions 871, 871'. The active region 822 is flexible, for example, it may include or be configured to provide a flexible bend 812, 812'. The active region of the ring may be arranged on an expandable member and / or at least partially attached to the expandable member. When the expandable member is expanded, the ring may be moved from Fig. 8A The narrower shape shown transitions to Figure 8BThe flexible bend 812 has an initial angle (e.g., between about 90 and 160 degrees) that can increase as the expandable member expands to an expanded angle greater than the initial angle (e.g., up to about 180 degrees). FIG. 8A to FIG. 8B As shown, the active region changes shape to increase the effective radial circumferential distance 860, 860' of the electrode assembly of which it forms a part.

[0179] In any of these devices, the electrode assembly may include a plurality of petals that may be arranged circumferentially, such as Figure 8C In addition, as described above, the electrode assemblies can be arranged adjacent to each other along the length of the expandable member. In the unexpanded configuration and the expanded configuration, for example, when the expandable member is expanded, the spacing between adjacent active areas of the electrode assemblies can be approximately the same along the length of the active areas.

[0180] exist Figure 8C In the apparatus, the apparatus includes four electrode assemblies 822, 823, 824, 825 formed from a plurality of small diameter wires (e.g., wires having a diameter of 0.015" or less). Figure 8C In the embodiment, the wire is arranged on an expandable balloon 828. Each electrode assembly forms three petals arranged on the balloon. Figure 8C , four electrode assemblies are shown, each electrode assembly having three active areas, one active area for each petal. The active area of ​​each electrode assembly includes a flexible bend 812 approximately midway along the active area. In this example, the electrode assemblies can be paired such that the first electrode assembly 822 and the third electrode assembly 824 can have a first polarity, and the second electrode assembly 823 and the fourth electrode assembly 825 can have a second polarity. In some examples, the first electrode assembly and the third electrode assembly can be electrically coupled together, and the second electrode assembly 823 and the fourth electrode assembly 852 can be electrically coupled together. Optionally, the first electrode assembly, the second electrode assembly, the third electrode assembly, and the fourth electrode assembly can be individually addressable. The balloon is positioned in an elongated body such as a catheter elongated body ( Figure 8C The balloon can be deflated to collapse the radial profile (eg, diameter) of the device and can be inflated to expand the radial profile; Figure 8C , a device with the balloon relatively collapsed is shown. The laterally spaced active areas of the electrode assemblies 822, 823, 824, 825 may be spaced, for example, about 1 mm or less (e.g., 0.5 mm, etc.) to 10 mm apart. The active areas in this example are formed on either side by insulating portions 871, 871'.

[0181] Fig.8D and Fig.8DAn example of a device is shown having an elongated member (e.g., a shaft) 829, four electrode assemblies 822, 823, 824, 825, each electrode assembly having four petals forming an active region, each active region comprising a flexible bend 812, 813, 814, 815 arranged on an expandable balloon 828. The wires forming the electrode assemblies may be shape memory alloy (e.g., Nitinol) wires that are circumferentially arranged in a ring (forming a petal) around a compliant or semi-compliant balloon 828. Fig.8D As shown, four identical petals are arranged around the balloon. In some embodiments, each loop of the nitinol wire can be shaped so that there is a V-shape (flexible bend), such as Fig.8D When the guidewire is placed over an uninflated or minimally inflated balloon, the V-bend has a minimum angle ( Fig.8D ). This angle increases as the balloon inflates, Fig. 8E The V-shape allows the wire to expand as the balloon expands and thus does not restrict expansion of the balloon, as might occur without a flexible bend in the wire of the electrode assembly. In various examples, the balloon can also act as an insulator to prevent arcing between electrodes of different polarities. For example, the balloon can be formed of an electrically insulating material.

[0182] Fig. 8E Shown with Fig.8D The same device, wherein the balloon 828 is expanded. As described above, the active area of ​​each petal forming the electrode assembly is from Fig.8D The first bend angles 812, 813, 814, 815 shown transition to Fig. 8E More open (larger) bend angles 812', 813', 814', 815' are shown.

[0183] The electric field strength between active areas of the electrode assembly (e.g., wires) can be varied by varying the applied voltage and / or by varying the distance between the wires. Fig.8D and Fig. 8E As shown, in some examples, the distance between active areas is fixed and cannot be changed, i.e., is not adjustable. In addition, these devices can be configured so that when the shape of each active area changes, for example by bending the flexible bend during expansion / deflation of the balloon, the spacing or distance between the active areas remains constant along the length of the active area.

[0184] exist FIG. 8D to FIG. 8EFour petals are shown in . In general, any suitable number of petals may be used. For example, to generate circumferential ablation without rotating the catheter, at least two petals may be used. In some examples, 3, 4, 5, or 6 (or more) petals may be used and may be arranged around the balloon. While more petals may better maintain the distance between the wires, more petals may also increase the cross-sectional profile of the device because it may require more space to fit within the shaft 829 of the device, which may increase the minimum size of the device.

[0185] 9A to 9C Other examples of devices as described herein are shown. For example, in Fig.9A In some examples (see, e.g., FIG. 8C to FIG. 8E ), the elongated shaft can extend through the balloon. In this example, the balloon is transparent, and six electrodes (three pairs) 922, 923, 924, 925, 926, 927 forming four petals are arranged on the balloon. The wires are collected into four ribs 939, 940. Fig. 9B and Fig. 9C Shown with Fig.9A Another example of a device 900' similar to the device shown in the figure, in which the balloon 928' is opaque. In this example, the six electrodes (three pairs) 922, 923, 924, 925, 926, 927 also form four petals arranged on the balloon. Each of the six active areas of each electrode assembly includes a flexible bend 912, 913, 914, 915, 916, 917 as described above and Fig. 9C As shown in more detail in . Any number of electrode assemblies (e.g., wires) may be used as appropriate. For example, if a larger area needs to be ablated, the number of electrode assemblies may be increased and / or the distance between active areas of the electrode assemblies may be increased. For example, if the desired length of the ablation area is 10 mm and the distance between active areas of the electrode assemblies is 1 mm, 11 electrode assemblies (wires) may be arranged on the balloon. As will be appreciated by those skilled in the art, any appropriate number of wires and distances between wires may be achieved.

[0186] In any of these devices, the electrode assembly may be coupled to the balloon along all or a portion of the length of the electrode assembly wire. In some examples, the wire loops of one or more electrode assemblies are attached to the balloon at several attachment areas (such as at a flexible bend and / or at a rib). In some examples, the wire loops can be slidably attached to the balloon (e.g., via threaded attachment, etc.). In some examples, discrete attachment areas couple the first ring and / or rib, the second ring and / or rib, etc. In some examples, the electrode assembly is not attached to the expandable member. The electrode assembly may be shaped, for example, as an expanded or unexpanded configuration.

[0187] Methods of using the disclosed device

[0188] The devices described herein may include or be included as part of a catheter used during minimally invasive surgery or as part of a device used during surgery. As described above, the devices described herein can be used to treat body lumens by applying pulsed sub-microsecond (e.g., nanosecond) energy. For example, these devices can be used to treat arterial stenosis or restenosis. In some examples, these devices can be used to treat Barrett's esophagus.

[0189] In general, the methods and devices described herein can be used to apply sub-sub-microsecond (e.g., nanosecond) pulsed energy. However, any of the devices described herein can also be configured to apply other types of energy, such as RF or micro-pulse-based electric field energy.

[0190] In some examples, the device described herein can be inserted and / or used with a catheter, an introducer or other delivery device through a catheter, an introducer or other delivery device. For example, any of these devices can be inserted through the working channel of an endoscope (such as a bronchoscope or a gastroscope). In some examples, the device may include a catheter, for example, having an expandable active area including an electrode, which can be used with an expansion frame (e.g., struts, ribs, etc.) and / or a balloon, which can be used in the bronchial system or esophagus and can be introduced through the working channel of a bronchoscope or a gastroscope. An endoscope (e.g., a bronchoscope or a gastroscope) can be placed adjacent to a treatment site, which can be visualized (imaged) via a scope or camera such as a bronchoscope (a camera built into a scope). Then, the device can be introduced through the working channel of the scope. Subsequently, the device (e.g., a frame and / or a balloon) can be expanded so that it expands and the electrodes on the surface of the frame / balloon are placed in contact with the tissue of the treatment site. Then, energy can be delivered to the electrode. The device can then be collapsed (e.g., by deflation of the balloon, contraction of the frame, etc.) and repositioned by moving the device or the scope and apparatus together to the next treatment site, where the active area expansion and energy application can be repeated.

[0191] For example, the devices of the present disclosure can be used to treat intracavitary cancers, for example, by inserting the devices of the present disclosure through body vessels (using a catheter, or, where applicable, a laparoscopic device), expanding the device at the treatment site (e.g., at or near the cancer in the lumen), and applying energy, especially nanosecond pulsed electrical energy, to treat tissue. In some examples, the devices described herein can be used to treat the prostate, such as for treating prostate cancer and / or benign prostatic hyperplasia. For example, methods for treating the prostate by inserting the devices described herein through the urethra (e.g., using various catheter-based designs described herein) are described herein. In some examples, the device can be inserted transurethrally, and in some examples, the device can be inserted percutaneously. Transurethral delivery can include inserting an intracavitary catheter through the penis, through the urethra and into the prostate, where energy delivery can be applied.

[0192] Other examples of treatable tissues may include the lung (eg, to treat lung cancer), pancreas (eg, pancreatic cancer), etc. Other exemplary tissues (body vessels) and treatment methods are described herein.

[0193] Cardiac ablation methods

[0194] The methods and devices described herein can use pulsed electrical energy (e.g., microsecond, sub-microsecond, nanosecond, etc. pulsed electrical energy) to treat atrial fibrillation, ventricular tachycardia, and perform other heart-related ablations. The applicators described herein can be used to deliver pulsed electrical energy to a desired treatment area during minimally invasive surgery or during surgery (such as during cardiac surgery).

[0195] For example, these methods and devices can be used to perform cardiac ablation by delivering pulsed energy to the coronary arteries and peripheral arteries and veins. For example, any of the applicators described herein can be used to deliver pulsed energy to the sinus of the pulmonary vein. Specifically, the applicator can conform to a transition region of the sinus that starts with a relatively larger area (relative to the distal region of the applicator) and transitions to a relatively smaller area. A first or distal electrode having a relatively smaller diameter can contact the smaller area, while a second or proximal electrode having a relatively larger diameter can contact the larger area.

[0196] In another example, the diameter sizes of the first electrode and the second electrode may be reversed such that the diameter of the first electrode is relatively larger than the diameter of the second electrode. Use of such an applicator may be well suited for treating tissue regions starting with a relatively smaller area and transitioning to a relatively larger area.

[0197] An example of the use of the applicators described herein is to deliver a single ablation for pulmonary vein isolation in the left atrium to treat atrial fibrillation. To access the left atrium, a puncture of the femoral vein can be performed using a needle under fluoroscopic and / or ultrasound guidance. After the puncture under fluoroscopic guidance, a 0.032-inch J-tip guidewire can be advanced. The needle can be removed and a sheath introducer (typically sized 8F-12F) can be inserted into the vein and then flushed. A transseptal sheath (which can carry any applicator described herein) is advanced over the guidewire to the superior vena cava (SVC). Alternatively, with the initial puncture completed in the femoral vein, the device of the present disclosure can be advanced through the inferior vena cava (IVC).

[0198] Once the sheath is positioned within three to four centimeters (cm) above the caval-atrial junction, the wire is removed. The transseptal puncture needle is advanced under fluoroscopic guidance until it reaches the tip of the sheath. The needle is advanced with the stylet inserted until it reaches a position 4 cm from the tip. The stylet prevents the needle tip from scraping the inner lumen of the sheath. The stylet can then be removed. The puncture is performed and the sheath is advanced into the left atrium. A catheter with electrodes can be introduced into the left atrium through the sheath.

[0199] The electrode can be pushed against the wall of the left atrium, especially around the wall of the pulmonary vein. The proper positioning of the electrode can be assisted by the deflectable or fully articulated distal end of the elongated catheter body, which is controlled by the mechanism in the elongated handle and the pull wire in the shaft of the elongated catheter body. Fluoroscopy and / or ultrasound (TEE and / or ICE) and impedance and / or magnetic positioning achieved by the additional electrodes and / or magnetic sensors of the catheter can be used to verify the proper position of the catheter. The appropriate contact between the electrode of the applicator and the wall of the left atrium can be verified via impedance readings achieved by sending, for example, low-amplitude non-therapeutic electrical "test" signals. Active electrodes and / or electrodes for impedance-based positioning and / or contact assessment before ablation can be used for post-ablation signal acquisition. For example, the absence of electrical signals from cardiac tissue can indicate effective acute effects from ablation. After confirming the proper position and contact of the electrode, energy (nanosecond pulses, microsecond pulses, RF) can be applied to achieve the desired ablation effect. Complete pulmonary vein isolation can be achieved by subsequent repositioning of the catheter and distal bipolar pair and repeated application of energy to additional left atrial regions surrounding other pulmonary veins.

[0200] Pulsed electrical (e.g., nanosecond pulse) therapy may include a pulse profile having a rise and / or fall time of the pulse that 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 examples, the pulse voltage may be less than 1 kV, less than 5 kV, about 5 kV, between about 5 kV and about 10 kV, about 15 kV, about 20 kV, about 25 kV, about 30 kV, greater than 5 kV, greater than 10 kV, greater than 15 kV, greater than 20 kV, greater than 30 kV, etc. In some examples, the current may be less than 10A, about 10A, about 25A, about 40A, about 50A, about 60A, about 75A, about 100A, about 125A, about 150A, about 175A, about 200A, or greater than 200A. In some examples, the pulse duration may be less than 10 ns, about 10 ns, about 15 ns or less, about 20 ns or less, about 25 ns or less, about 30 ns or less, about 40 ns or less, about 50 ns or less, about 60 ns or less, about 75 ns or less, about 100 ns or less, about 125 ns or less, about 150 ns or less, about 175 ns or less, about 200 ns or less, about 300 ns or less, about 400 ns or less, about 500 ns or less, about 750 ns or less, about 1 μs or less, about 2 μs or less, about 3 μs or less, about 4 μs or less, about 5 μs or less, or greater than 5 μs. In addition to the instrument (e.g., the elongated applicator tool), the apparatus (e.g., the system) described herein may also include a pulse generator such as Figure 1 A pulse generator is schematically shown in FIG. 1 , which is configured to emit pulses, for example in the sub-microsecond range.

[0201] Generally speaking, the systems of the present disclosure may include additional elements, such as a power source, and / or a high voltage connector for safely connecting the elongated applicator tool device to a high voltage power source. As described above, these systems and devices are configured to apply high voltage, sub-microsecond pulsed electrical energy.

[0202] Fig.10 is a flow chart depicting an example of a method 1000 for delivering pulsed electrical therapy to a selected treatment area of ​​a patient. Some examples may perform the methods described herein with additional operations, fewer operations, operations in a different order, operations in parallel, and some different operations. The method 1000 may be used to treat atrial fibrillation, ventricular tachycardia, or other cardiac conditions. The method 1000 is not limited to cardiac applications, but may also be used to treat various body vessels.

[0203] exist Fig.10In the method 1000, the treatment area may be identified in block 1002. Block 1002 may be optional. Fig.10 For example, one or more diagnostic tests for a patient may identify an area of ​​a vein, artery, or other body vessel to receive pulsed electrical therapy. In other examples, the treatment area may be any technically feasible lumen, channel, or structure. The diagnostic tests may include radiological tests, vascular tests, ultrasound tests, or any other feasible tests capable of identifying the treatment area.

[0204] In block 1004, the applicator is positioned within the identified treatment area. For example, Figure 1 The system 100 may be used to attach an applicator (such as, but not limited to, FIG. 4A to FIG. 4C , Figure 5 A to Figure 5 B) is positioned within the identified treatment area. For example, the applicator can be positioned by expanding a first electrode (e.g., a first annular electrode having one or more rings) and a second electrode (e.g., a second annular electrode having one or more rings) that are spaced apart.

[0205] In block 1006, the electrodes of the applicator may be placed in contact with the target tissue in the identified treatment area. The electrodes may be positioned so that an active area on the first electrode (which may extend circumferentially (completely or partially) on the target tissue) is spaced apart from an active area on the second electrode (which may also extend circumferentially (completely or partially) on the target tissue). The area between the active areas of the first electrode and the second electrode may be treated. In some examples, the first active area of ​​the first electrode and the second active area of ​​the second electrode may be placed circumferentially around an inner cavity (e.g., a vessel wall); in some examples, the first active area of ​​the first electrode and the second active area of ​​the second electrode may be placed circumferentially around a portion of a body vessel, for example, in one non-limiting example, around the sinus of a pulmonary vein. In some cases, the electrode may be operably connected to the elongated catheter body so that the electrode is in contact with the tissue. In some other cases, the electrode may emerge from the elongated catheter body and expand to allow the electrode to enter the treatment area. After expansion, the applicator may be moved to place the electrode in contact with the tissue.

[0206] When the electrodes are placed in contact with the tissue, in some examples, the spacing (e.g., longitudinal spacing) between the electrodes (e.g., electrode groups) on the applicator can be adjusted. The spacing between the electrodes on the applicator can be adjusted to change the density of the pulsed electric field or to accommodate changing tissue shapes and topologies.

[0207] In optional block 1007, contact with tissue may be confirmed by any suitable method (e.g., impedance testing, electrograms, imaging, etc.). In this optional step, a low level or low amplitude signal (e.g., voltage and / or current) may be provided to the electrode. The system 100 may determine and / or measure the impedance associated with the electrode based on the signal provided to and returned from the electrode. When the impedance is within an expected value, contact with tissue may be confirmed.

[0208] In any of these methods, tissue, particularly tissue surrounding an electrode (e.g., an electrode for applying treatment) may be mapped using mapping electrodes on the device (including, for example, those shown in FIGS. 3 to 4). Figure 6 1011 is marked using mapping electrodes on radially opposite sides of the treatment electrodes seen in FIG.

[0209] In block 1008, pulsed electrical therapy is applied to the identified treatment area by the applicator. For example, the system 100 can deliver energy by the applicator (e.g., between the active area of ​​the first electrode and the active area of ​​the second electrode). In some examples, the energy can be provided by a pulse generator configured to provide electrical pulses having an amplitude greater than 0.1 kV and a duration less than 1000 nanoseconds.

[0210] Additional treatments may be performed, including repeated application of energy to the tissue via the first electrode and the second electrode; the effectiveness of each pulse of electrical treatment may be evaluated. If the treatment is adequate, no further treatment is required (e.g., as determined by imaging, impedance testing, electrograms, etc.). In some examples, it may be advantageous to apply energy in a circumferential pattern as described herein (see, e.g., FIG. 4A to FIG. 4C , Figure 5 A to Figure 5 B, etc.), without having to move the equipment to obtain near-complete or complete circumferential treatment.

[0211] In block 1010, the electrodes of the applicator are withdrawn from the tissue. In some cases, the catheter may be moved relative to the surface of the tissue already treated to provide further treatment. The applicator may be moved to another treatment area or may be removed from the patient.

[0212] For ease of description, the foregoing methods and apparatus describe the example of arterial treatment using pulsed electrical therapy. However, other treatments are contemplated.

[0213] All publications and patent applications mentioned in this specification are incorporated herein by reference in their entirety, to the same extent as if each individual publication or patent application was specifically and individually indicated to be incorporated by reference. In addition, it should be understood that all combinations of concepts discussed in this disclosure (provided such concepts are not mutually inconsistent) are considered part of the inventive subject matter disclosed herein and can be used to achieve the benefits described herein.

[0214] As mentioned 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, a robotic system can include a movable (robotic) arm to which an elongated applicator tool is coupled. Various motors and other movement devices can be incorporated to enable fine movement of the operating tip of the elongated applicator tool in multiple directions. The robotic system and / or the elongated applicator tool can further include at least one image acquisition device (and preferably two, or more for stereoscopic vision), which can be mounted in a fixed position or can be coupled (directly or indirectly) to a robotic arm or other controllable motion device. In some examples, the image acquisition device can be incorporated into the elongated applicator tool.

[0215] Examples of the methods of the present disclosure may be implemented using computer software, firmware, or hardware. Various programming languages ​​and operating systems may be used to implement the present disclosure. The program for operating the method and system may include a separate program code that includes a set of instructions for performing a desired operation or may include multiple modules that perform such sub-operations of the operation or may be part of a single module of a larger program that provides the operation. Modular construction facilitates adding, deleting, updating, and / or modifying modules therein and / or features within the modules.

[0216] In some examples, a user may select a particular method or example of the present application, and the processor will run a program or algorithm associated with the selected method. In some examples, various types of positioning sensors may be used. For example, in some examples, a non-optical encoder may be used, where the voltage level or polarity may be adjusted based on the encoder signal feedback to achieve a desired angle, speed, or force.

[0217] Certain examples may relate to machine-readable media (e.g., computer-readable media) or computer program products, which include program instructions and / or data (including data structures) for performing various computer-implemented operations. Machine-readable media can be used to store software and data that enable a system to perform the method of the present disclosure. The above-mentioned machine-readable media may include any suitable medium that can store and transmit information in a form accessible to a processing device such as a computer. Some examples of machine-readable media include, but are not limited to, disk storage, such as hard disks, floppy disks, and magnetic tapes. It may also include flash memory devices, optical storage, random access memory, etc. Data and program instructions may also be embodied on a carrier or other transmission medium. Examples of program instructions include both machine code such as generated by a compiler and files containing higher-level code that can be executed using an interpreter.

[0218] Any of the methods described herein, including user interfaces, may be implemented as software, hardware, or firmware, and may be described as a non-transitory computer-readable storage medium storing a set of instructions executable by a processor (e.g., a computer, tablet, smart phone, etc.) that, when executed by the processor, causes the processor to perform or control the performance of any of the steps, including but not limited to: displaying, communicating with a user, analyzing, modifying parameters (including timing, frequency, intensity, etc.), determining, sounding an alarm, etc. In some exemplary examples, hardware may be used in conjunction with software instructions to implement the present disclosure.

[0219] When a feature or element is referred to as being "on" another feature or element in this article, it can be directly located on another feature or element, or there can also be intermediate features and / or elements. On the contrary, when a feature or element is referred to as "directly located" on another feature or element, there are no intermediate features or elements. It should also be understood that when a feature or element is referred to as "connected", "attached" or "coupled" to another feature or element, it can be directly connected, attached or coupled to another feature or element or there can be intermediate features or elements. On the contrary, when a feature or element is referred to as being "directly connected", "directly attached" or "directly coupled" to another feature or element, there are no intermediate features or elements. Although described or shown with respect to an example, the features and elements described or shown in this way can be applied to other examples. It will also be understood by those skilled in the art that the structure or feature mentioned to be "adjacent" to another feature can have a part overlapping or located under the adjacent feature.

[0220] The terms used herein are only for the purpose of describing specific examples and are not intended to limit the invention of the present disclosure. For example, unless the context clearly indicates otherwise, as used herein, the singular forms "a, an" and "the" are intended to include plural forms. It should also be understood that the terms "comprising" and / or "including" when used in this specification specify the presence of this feature, step, operation, element and / or part, but do not exclude the presence or addition of one or more other features, steps, operations, elements, parts and / or combinations thereof. As used herein, the term "and / or" includes any and all combinations of one or more of the associated enumerated items and can be abbreviated as " / ".

[0221] For ease of description, spatial relative terms such as "under", "below", "lower", "above", "upper", etc. may be used herein to describe the relationship between an element or feature and another one or more elements or another one or more features, as shown in the figure. It will be understood that, in addition to the orientation depicted in the accompanying drawings, spatial relative terms are also intended to cover different orientations of the device when in use or in operation. For example, if the device in the accompanying drawings is inverted, the elements described as "under" or "below" other elements or features will be oriented to be "above" other elements or features. Therefore, the exemplary term "under" can cover both "above" and "below" orientations. The device can be oriented in other ways (rotated 90 degrees or in other orientations), and the spatial relative descriptors used in this article are interpreted in a corresponding manner. Similarly, unless otherwise specifically noted, the terms "upward", "downward", "vertical", "horizontal", etc. are used herein only for the purpose of explanation.

[0222] Although the terms "first" and "second" may be used herein to describe various features / elements (including steps), these features / elements should not be limited by these terms unless the context otherwise indicates. These terms can be used to distinguish one feature / element from another feature / element. Therefore, without departing from the teachings of the present invention, the first feature / element discussed below may be referred to as the second feature / element, and similarly, the second feature / element discussed below may be referred to as the first feature / element.

[0223] Throughout this specification and the claims that follow, unless the context requires otherwise, the word "comprise" and variations such as "comprises" and "comprising" refer to various components that can be employed together in methods and articles of manufacture (e.g., devices including apparatus and methods). For example, the term "comprising" will be understood to imply the inclusion of any stated elements or steps, but not the exclusion of any other elements or steps.

[0224] In general, any of the devices and methods described herein should be understood to be inclusive, but all or a subset of components and / or steps may alternatively be exclusive where they may be expressed as "consisting of various components, steps, sub-components or sub-steps" or alternatively "consisting essentially of various components, steps, sub-components or sub-steps."

[0225] As used herein in the specification and claims, including as used in the examples, and unless otherwise expressly specified, all numbers, even if the term does not expressly appear, may be read as being preceded by the word "about" or "approximately". When describing a magnitude and / or a position, the phrase "about" or "approximately" may be used to indicate that the described value and / or position is within a reasonable expectation range of the value and / or position. For example, a value may have + / -0.1% of a specified value (or value range), + / -1% of a specified value (or value range), + / -2% of a specified value (or value range), + / -5% of a specified value (or value range), + / -10% of a specified value (or value range), etc. Any value given herein should also be understood to include about or approximate the said value, unless the context otherwise indicates. For example, if the value "10" is disclosed, then "about 10" is also disclosed. All numerical ranges recited herein are intended to include all sub-ranges subsumed therein. It should also be understood that, as would be appreciated by a person skilled in the art, when a disclosed value is "less than or equal to" the said value, "greater than or equal to the said value" and the possible ranges between the values are also disclosed. For example, if the value "X" is disclosed, then "less than or equal to X" and "greater than or equal to X" are also disclosed (e.g., where X is a numerical value). It should also be understood that throughout the application, data is provided in a variety of different formats, and this data represents ranges of endpoints and starting points and any combination of data points. For example, if a particular data point "10" and a particular data point "15" are disclosed, then it should be understood that greater than, greater than or equal to, less than, less than or equal to, and equal to 10 and 15 and between 10 and 15 are considered disclosed. It should also be understood that each unit between two particular units is also disclosed. For example, if 10 and 15 are disclosed, then 11, 12, 13, and 14 are also disclosed.

[0226] Although the various illustrative examples are described above, any of a variety of changes may be made to the various examples without departing from the scope of the invention as claimed. For example, in alternative examples, the order of performing the various method steps may often be changed, and in other alternative examples, one or more method steps may be completely skipped. Optional features of the various apparatus and system examples may be included in some examples and not included in other examples. Accordingly, the present description is provided primarily for exemplary purposes and should not be construed as limiting the scope of the invention set forth in the claims.

[0227] The examples and descriptions included herein show specific embodiments in which the subject matter can be practiced by way of illustration and not limitation. As mentioned, other examples and variations can be utilized and other embodiments can be obtained therefrom, so that structural and logical substitutions and changes can be made without departing from the scope of the present disclosure. These examples of the subject matter of the present invention may be referred to herein individually or collectively as the term "invention", which is only for convenience, and if more than one invention or inventive concept is actually disclosed, this does not mean that the scope of the present application is voluntarily limited to any single invention or inventive concept. Therefore, although specific examples have been illustrated and described herein, any arrangement suitable for achieving the same purpose can replace the specific examples shown. The present disclosure is intended to cover any and all adaptations or variations of each example. By reviewing the above description, the combination of some features of the above examples or provided examples and other examples not specifically described herein will be apparent to those skilled in the art.

Claims

1. A device for delivering a pulsed electric field, the device include: Slender body; a plurality of arms configured to extend from the elongated body at an angle in a deployed state; a first plurality of electrode segments extending between the plurality of arms and forming a first therapy electrode; a second plurality of electrode segments extending between the plurality of arms and forming a second therapy electrode, the second therapy electrode being radially outward of the first therapy electrode in the deployed state; and One or more mapping and / or sensing electrodes on an area extending radially outward from the second treatment electrode of each of the multiple arms, and one or more mapping and / or sensing electrodes on an intermediate area between the first treatment electrode and the second treatment electrode of each of the multiple arms.

2. The apparatus of claim 1, further comprising a central electrode.

3. The device of claim 2, wherein the central electrode comprises a mapping and / or sensing electrode, the central electrode being configured to extend distally from a distal end of the elongated body.

4. The device of claim 2 or 3, wherein the central electrode further comprises a central therapy electrode, wherein the central therapy electrode is configured to operate at a different polarity than at least one of the first therapy electrode or the second therapy electrode.

5. The device according to any one of claims 1 to 4, wherein the one or more mapping and / or sensing electrodes on the extended area include an electromagnetic sensor coupled to the extended area of ​​one or more arms of the plurality of arms.

6. An apparatus according to any one of claims 1 to 5, wherein at least some of the plurality of arms comprise a hollow insulating member, and at least a portion of the first electrode or the second electrode and / or an electrical connector extend within or through the hollow insulating member.

7. The apparatus of any one of claims 1 to 6, wherein each electrode segment of the first plurality of electrode segments forms an arc, and the arcs of the first plurality of electrode segments together surround the elongated body.

8. The apparatus of any one of claims 1 to 7, wherein the plurality of arms are pre-bent or biased to bend at an angle to the longitudinal axis of the elongate body when extending therefrom.

9. The apparatus of claim 8, wherein at least one of the plurality of arms is configured to bend to a different angle than at least another of the plurality of arms.

10. The device of any one of claims 1 to 9, wherein the plurality of arms comprises at least 3 arms, and the device further comprises a third plurality of electrode segments extending between the 3 arms and forming a third therapy electrode.

11. A device for delivering a pulsed electric field, the device include: Slender body; a first plurality of arms configured to extend from the elongated body at an angle in a deployed state; a second plurality of arms configured to extend from the elongated body at an angle in the deployed state; a first plurality of electrode segments extending between the first plurality of arms and forming first therapy electrodes; a second plurality of electrode segments extending between the second plurality of arms and forming a second therapy electrode, the second therapy electrode being axially separated from the first therapy electrode by a plurality of struts; wherein the plurality of struts extend substantially parallel to a distal end region of the elongated body between the first therapy electrode and the second therapy electrode; and One or more mapping and / or sensing electrodes on at least some of the plurality of struts.

12. An apparatus according to claim 11, wherein the one or more mapping and / or sensing electrodes include a plurality of mapping and / or sensing electrodes, and at least some of the plurality of mapping and / or sensing electrodes are on either or both of the first plurality of arms and the second plurality of arms.

13. The apparatus of claim 11 or 12, wherein the brace of the plurality of braces is coupled to at least one of the first plurality of arms and the second plurality of arms.

14. The apparatus of any one of claims 11 to 13, wherein the first plurality of arms are rotationally offset from the second plurality of arms.

15. A device according to any one of claims 11 to 14, wherein the arms of the first plurality of arms and the second plurality of arms are configured to transition from an undeployed state to a deployed state, wherein each arm of the plurality of arms is at least partially within the slender body, and wherein each arm of the first plurality of arms and the second plurality of arms extends from the slender body at a certain angle in the deployed state.

16. The device according to any one of claims 11 to 15, wherein the arms of the first plurality of arms and / or the second plurality of arms are configured to extend from the slender body at an angle between 20 degrees and 90 degrees relative to the slender body in the deployed state.

17. The device according to any one of claims 11 to 16, further comprising a central electrode configured to extend distally from the distal end of the slender body, wherein the central electrode comprises a mapping and / or sensing electrode.

18. The device of any one of claims 11 to 16, further comprising a central electrode configured to extend distally from the distal end of the elongated body, wherein the central electrode comprises a central treatment electrode.

19. The device of claim 18, wherein the device is further configured to apply bipolar energy between: 1) the central electrode and at least one electrode segment of the first plurality of electrode segments, 2) the central electrode and at least one electrode segment of the second plurality of electrode segments, or 3) at least one electrode segment of the first plurality of electrode segments and at least one electrode segment of the second plurality of electrode segments.

20. The apparatus of any one of claims 11 to 19, wherein substantially parallel to the distal end region of the elongate body comprises at most plus / minus 10 degrees from a longitudinal axis of the distal end region of the elongate body.

21. A device for delivering a pulsed electric field, the device include: Slender body; a balloon on said elongated body; a first electrode comprising a first plurality of wire loops, wherein each of the first plurality of wire loops extends from the elongated body to form a petal disposed about the balloon, and further wherein each of the first plurality of wire loops has a first active region extending along at least a portion of a length of each first wire loop; and a second electrode comprising a second plurality of wire loops, wherein each of the second plurality of wire loops extends from the elongated body, further wherein each of the second plurality of wire loops has a second active region extending along at least a portion of the length of each second wire loop, Wherein the first electrode is laterally offset from the second electrode along the length of the balloon, and further, wherein each first active area in the first active area and each second active area in the second active area includes a flexible bend, and the angle of the flexible bend is configured to expand as the balloon expands.

22. The apparatus of claim 21, wherein at least one or both of the first plurality of wire loops and the second plurality of wire loops comprises from 2 to 5 loops.

23. The apparatus of claim 21 or 22, wherein each of the first plurality of wire loops and each of the second plurality of wire loops are coupled to an outer surface of the balloon at one or more points.

24. The apparatus of any one of claims 21 to 23, wherein each of the first plurality of wire loops and each of the second plurality of wire loops are slidably coupled to an outer surface of the balloon.

25. The apparatus of any one of claims 21 to 24, wherein each of the first active regions and each of the second active regions is bounded on either side by an insulating region.

26. The apparatus of any one of claims 21 to 25, wherein the first active region of each of the first plurality of wire loops is spaced apart a fixed distance from the second active region of each of the second plurality of wire loops.

27. The apparatus of any one of claims 21 to 25, wherein the first electrode and the second electrode are each formed from a wire having a diameter of less than 0.2 mm.

28. The apparatus of any one of claims 21 to 27, wherein the first electrode is configured to have a first polarity and the second electrode is configured to have a second polarity.

29. The device of any one of claims 21 to 28, wherein the plurality of wire loops of the first electrode and the plurality of wire loops of the second electrode include a distal region configured as a hinge that expands or contracts as the balloon expands or contracts.

30. The apparatus of any one of claims 21 to 29, wherein the plurality of wire loops of the first electrode and the plurality of wire loops of the second electrode are arranged completely around the circumference of the balloon.

Images