Pulmonary vein isolation catheters and related devices, systems, and methods

Abstract

Disclosed herein are pulmonary vein isolation catheters and related devices, systems, and methods. In some implementations, a pulmonary vein isolation catheter includes a tip portion having an expandable portion and a deployment member. The expandable portion includes a plurality of mesh electrode pads that are electrically insulated from one another. The expandable portion is mechanically coupled to (i) the deployment member at a distal-most portion of the tip portion and (ii) a distal end portion of a catheter shaft. The expandable portion is expandable and compressible via proximal and distal movement of the deployment member, respectively. In some embodiments, the expandable portion in a deployed state is pear-shaped or onion-shaped and includes a nose portion and / or an active body portion. The nose portion can be insulated and / or configured to fit within a pulmonary vein and set a position of the active body portion against tissue around a pulmonary vein ostium.

Description

[0001] This application is a divisional application of the invention patent application entitled "Pulmonary vein isolation catheter and related devices, systems and methods", filed on December 16, 2020, with international application number PCT / US2020 / 065314 and Chinese national phase application number 202080096828.5. Technical Field

[0002] This application relates to medical catheters, particularly pulmonary vein isolation catheters and related devices, systems, and methods. Background Technology

[0003] Atrial fibrillation is an abnormal heart rhythm characterized by rapid or irregular beating of the atria of the heart. One possible cause of atrial fibrillation is extra cardiac firing caused by the pulmonary veins, which carry oxygenated blood from an individual's lungs to the left atrium of the heart. Therefore, a common treatment for atrial fibrillation is to electrically isolate one or more pulmonary veins from the left atrium using a catheter configured to deliver ablation energy around one or more pulmonary vein ostiums. Brief description of the attached figures

[0004] Many aspects of this disclosure can be better understood with reference to the following accompanying drawings. The components in the drawings are not necessarily drawn to scale. Instead, the focus is on clearly illustrating the principles of this disclosure. The drawings should not be construed as limiting the disclosure to the specific embodiments depicted, but are for explanation and understanding only.

[0005] Figure 1 This is a schematic diagram of a system configured according to several embodiments of the present technology for treating human patients.

[0006] Figure 2 It is configured according to several embodiments of the present technology. Figure 1 A three-dimensional diagram of the system's medical device.

[0007] Figure 3A and 3B It is configured according to several embodiments of the present technology. Figure 2 A schematic diagram of the end portion of a medical device.

[0008] Figure 4 It is configured according to several embodiments of the present technology. Figure 2 A schematic diagram of the unfolding components of a medical device.

[0009] Figure 5 It is configured according to several embodiments of the present technology. Figure 2 A top view of the farthest part of the distal portion of the medical device.

[0010] Figure 6A and6B This is a schematic diagram of the end portion of a medical device in a compressed state and an unfolded state, according to several embodiments of the present technology.

[0011] Figure 7A and 7B It is configured according to several embodiments of the present technology. Figure 2 A schematic diagram of a modular electrode plate at the end of a medical device.

[0012] Figure 8A It is used for connecting to the configuration according to embodiments of this technology. Figure 2 Exploded view of the holes and corresponding rivets of multiple plates of the modular electrode of the medical device.

[0013] Figure 8B It is used to connect multiple embodiments configured according to the present technology. Figure 2 A schematic diagram of the holes and rivets in multiple plates of electrodes at the end of a medical device.

[0014] Figure 8C It is a connection configured according to multiple embodiments of the present technology. Figure 2 A cross-sectional view of the two eyelets of the rivet on the electrode plate at the end of the medical device.

[0015] Figure 8D It is configured according to several embodiments of the present technology. Figure 2 A schematic diagram of the assembled end portion of a medical device.

[0016] Figure 9A and 9B These are configured according to various embodiments of the present technology. Figure 2 Exploded view and partial cross-sectional view of the nasal portion of the distal end of the medical device.

[0017] Figure 10A and 10B These are configured according to various embodiments of the present technology. Figure 2 Exploded view and side view of the proximal portion of the distal part of the medical device.

[0018] Figure 11A and 11B This is a schematic diagram of the end portion of a medical device in an unfolded state, configured according to several embodiments of the present technology.

[0019] Figure 12A and 12B They are Figure 11A and 11B Top view and top perspective of the farthest part of the end portion.

[0020] Figure 13 yes Figure 11A A side-view perspective of the end portion of the -12B.

[0021] Figure 14A -14C are respectively Figure 11A A cross-sectional view, a side perspective view, and a top perspective view of a portion of the end portion 124 of –13, schematically illustrating how a mesh electrode plate can be attached to form an expandable portion of the end portion 124 according to various embodiments of the present technology.

[0022] Figure 15 This is a schematic diagram of the end portion of a medical device configured according to several embodiments of the present technology.

[0023] Figure 16 This is a schematic diagram of the distal portion of a medical device configured according to several embodiments of the present technology, located at the pulmonary vein orifice within the anatomical structure of a patient.

[0024] Figure 17 This is a flowchart illustrating a method for positioning the distal portion of a medical device configured according to various embodiments of the present technology at a treatment site within the anatomical structure of a patient.

[0025] Figure 18 This is a flowchart illustrating a method for diagnosing and / or treating tissue at a treatment site within the anatomical structure of a patient, according to several embodiments of the present technology. Invention Details

[0026] A. Overview

[0027] As discussed above, atrial fibrillation is an abnormal heart rate caused by extra electrical discharges from the heart originating in the pulmonary veins. Therefore, a common treatment for atrial fibrillation is to electrically isolate one or more pulmonary veins from the left atrium using minimally invasive radiofrequency, cryotherapy, or pulsed field ablation catheters. Specifically, the catheter is used to deliver energy and create damage to the heart wall around the pulmonary vein orifices. The energy applied to the heart tissue at the treatment site blocks the tissue's electrical activity. In turn, this prevents abnormal electrical signals from the pulmonary veins from reaching the heart through the blocked tissue, thus preventing atrial fibrillation.

[0028] The inventors have recognized several challenges encountered in electrically isolating the pulmonary veins from the left atrium of the heart. For example, applying energy to the wall of the pulmonary vein (rather than just the wall of the heart in the left atrium around the pulmonary vein orifice) may cause unwanted narrowing of the pulmonary vein, or may fail to isolate all tissues that contribute to atrial fibrillation. Therefore, it is important to properly position the catheter tip at the pulmonary vein orifice before applying energy. Furthermore, the size of the pulmonary veins varies between patients and within the heart of an individual patient. Therefore, the catheter tip should be expandable to accommodate pulmonary veins of different sizes. Additionally, the effective surface area of ​​the energy delivery end varies with the expanded size of the catheter tip. Consequently, the current density applied via the catheter tip also varies. For this reason, granular control is needed on the amount of energy applied through the catheter tip and on the portion of the energized end used for energy application (both lacking in conventional pulmonary vein isolation catheters) to effectively adapt energy delivery to the patient's anatomy or other therapeutic conditions and avoid unwanted collateral damage to anatomical structures (e.g., the individual's esophagus).

[0029] To address these challenges, the inventors have developed a pulmonary vein isolation catheter with a distal portion comprising an expandable section formed by several mesh electrode plates. In some embodiments, the expandable section includes an insulated neck portion, an active modular electrode, and / or an insulated or non-insulated nasal portion. The nasal portion is configured to at least partially fit within the pulmonary vein and facilitates the proper positioning of the modular electrode against cardiac tissue surrounding the pulmonary vein orifice. Furthermore, the expandable section can expand to different degrees between a fully collapsed state (e.g., to allow passage through a guide sheath) and a fully extended state to accommodate pulmonary veins of various sizes. In these and other embodiments, the mesh electrode plates forming the expandable section together are electrically insulated from each other and can be individually powered. In this way, a pulmonary vein isolation catheter configured according to the present technology promises to provide granular control over which portions of the modular electrode are used to deliver energy to the tissue and the amount of energy delivered to the tissue region surrounding the modular electrode of the expandable section.

[0030] Specific details of several embodiments of this technology are referenced herein. Figure 1–18 is described. Although numerous embodiments have been described with respect to pulmonary vein isolation catheters and related devices, systems, and methods, other applications and embodiments besides those described herein are also within the scope of this technology. For example, unless otherwise stated or clearly stated from the context, the devices, systems, and methods of this technology can be used in any of a number of medical procedures, such as procedures performed on hollow anatomical structures of a patient, and more specifically, in procedures for stimulating, electrically isolating, or otherwise treating tissues within and / or near anatomical structures. Thus, for example, the systems, devices, and methods of this disclosure can be used as part of a medical treatment associated with the diagnosis, treatment, or both of a cardiac condition (e.g., arrhythmia). Additionally or alternatively, the devices, systems, and methods of this disclosure can be used in one or more medical procedures associated with other interventional procedures involving the ablation of target tissue (e.g., renal and / or carotid denervation).

[0031] It should be noted that other embodiments besides those disclosed herein are also within the scope of this technology. Furthermore, embodiments of this technology may have different configurations, components, and / or processes than those shown or described herein. Moreover, those skilled in the art will understand that embodiments of this technology may have configurations, components, and / or processes other than those shown or described herein, and that these and other embodiments may be without several of the configurations, components, and / or processes shown or described herein without departing from this technology.

[0032] As used herein, the term “physician” should be understood to include any type of medical personnel who may be performing or assisting in a medical procedure, and therefore includes doctors, nurses, medical technicians, other similar personnel, and any combination thereof. Additionally or alternatively, as used herein, the term “medical procedure” should be understood to include any manner and form of diagnosis, treatment, or both, including any preparatory activities associated with such diagnosis, treatment, or both. Thus, for example, the term “medical procedure” should be understood to include any manner and form of movement or placement of medical devices in an autopsy room. As used herein, the term “patient” should be considered to include human and / or non-human (e.g., animal) patients undergoing a medical procedure.

[0033] B. Selected embodiments of pulmonary vein isolation catheters and related devices, systems, and methods

[0034] 1. Pulmonary vein isolation catheter system

[0035] Figure 1 This is a schematic diagram of a system 100 configured for treating a patient 102 according to an embodiment of the present technology. Figure 1In the illustrated arrangement, system 100 is used to perform a medical procedure (e.g., pulmonary vein isolation procedure) on patient 102. System 100 may include a medical device 104 connected to interface unit 108 via extension cable 106. Interface unit 108 may include a graphical user interface 109, a processing unit 110 (e.g., one or more processors), and a storage medium 111. The graphical user interface 109 and storage medium 111 may be electrically connected to processing unit 110 (e.g., wired connection, wireless connection, or both). Unless otherwise stated or understood from the context, storage medium 111 may store computer-executable instructions thereon for causing one or more processors of processing unit 110 to perform one or more portions of the various methods described herein. Additionally or alternatively, storage medium 111 may store computer-executable instructions thereon for causing processing unit 110 and / or graphical user interface 109 to display various information collected by and / or related to medical device 104.

[0036] A drawing system 112, a recording system 113, a fluid pump 114, and a generator 115 can be connected to an interface unit 108. The fluid pump 114 can be detachably and fluidly connected to the medical device 104 via a fluid line 149. The generator 115 can also, or alternatively, be connected to the medical device 104 via one or more wires 148 and / or via one or more wires 147 to one or more return electrodes 118 attached to the skin of the patient 102. In use, electrical energy can be delivered from the generator 115 to the medical device 104, as described in further detail below, and ultimately to the distal portion 124 (e.g., to the modular electrodes of the distal portion 124). Figure 1 (Not shown) is used to ablate, treat, or diagnose tissue at the treatment site. The mapping system 112 can be used before and / or during the medical procedure to map the patient's tissue and determine which areas or regions of the tissue require treatment. The recording system 113 can be used throughout the medical procedure and before or after treatment.

[0037] Medical device 104 can be any of a number of different medical devices known in the art (e.g., for diagnosis, treatment, or both). In the illustrated embodiment, medical device 104 is a catheter 104 having a handle 120, a shaft 122, and a distal portion 124. The distal portion 124 generally includes any part of the catheter 104 that engages directly or indirectly with tissue for therapeutic, diagnostic, or both purposes, and thus can include the manner and type of full contact and / or non-contact interaction with tissues known in the art. For example, the distal portion 124 can include contact and / or non-contact interaction with tissue in the form of energy interaction (e.g., electrical energy, ultrasound energy, light energy, and any combination thereof), and further, or alternatively, can include the measurement of electrical signals emanating from the tissue. Thus, for example, the distal portion 124 can deliver energy (e.g., electrical energy) to tissue in an anatomical structure as part of any number of processes including therapeutic (e.g., radiofrequency (RF) ablation, irreversible electroporation, pulsed field ablation, etc.), diagnostic (e.g., mapping), or both.

[0038] At least a portion of the distal portion 124 and the shaft 122 can be inserted into the anatomical structures of the patient 102 (e.g., the heart) via a vein or artery in the patient's leg or arm. Specifically, the distal portion 124 may utilize a guide (e.g., a controllable sheath such as the AbbottAgilis™ controllable guide) and / or a guidewire. Figure 1 (Not shown) is delivered to the treatment site (e.g., to the pulmonary vein orifice in the left atrium of the patient's heart). In some embodiments, contrast agent injection and / or further advancement of the guidewire may be used to verify placement at the treatment site, as described in more detail below.

[0039] Figure 2 It is configured according to several embodiments of the present technology. Figure 1 A three-dimensional view of the conduit 104 of system 100. (See diagram below.) Figure 2 As shown, the handle 120 of the conduit 104 is coupleable to the proximal portion 230 of the shaft 122, and the distal portion 124 is coupleable to the distal portion 232 of the shaft 122 opposite to the proximal portion 230. The distal portion 124 includes an expandable portion 250 and a deployable member 235. As used herein, the terms “expandable” and “deformable” are used interchangeably unless otherwise stated or clearly indicated from the context. Thus, for example, it should be understood that the expandable portion 250 is deformable unless otherwise stated. The deployable member 235 extends from the distal portion 240 of the distal portion 124 to at least the proximal portion 230 of the shaft 122.

[0040] The shaft 122 can be formed from a variety of different biocompatible materials that provide sufficient rigidity and flexibility to allow manipulation of the shaft 122 through a patient's blood vessels. Examples of suitable materials for forming the shaft 122 include polyether block amides (e.g., Pebax®, available from Arkema Colomb, France), nylon, polyurethane, Pellethane® (available from Lubrizol, Wycliffe, Ohio), and silicone. In some embodiments, the shaft 122 comprises a variety of different materials along its length. For example, materials can be selected to provide increased flexibility to the shaft 122 distally compared to the proximal end. The shaft 122 may also, or alternatively, include a tubular braided element that provides torsional stiffness while maintaining flexural flexibility to one or more regions of the shaft 122. Further, or alternatively, the shaft material may include radiopaque reagents such as barium sulfate or bismuth to facilitate fluoroscopic visualization.

[0041] In these and other embodiments, shaft 122 may define a connection compatible with fluid pump 114 ( Figure 1 A fluid-communicating cavity. For example, in some embodiments, shaft 122 defines a cavity extending from the proximal portion 230 of shaft 122 to the distal portion 232 of shaft 122. The cavity may be accessible via fluid conduit 149 ( Figure 1 The fluid line connection 249 of the handle 120 is in fluid communication with the fluid pump 114, allowing fluid (e.g., brine, contrast dye, etc.) to be pumped from the fluid pump 114 to the end portion 124. Alternatively or additionally, the shaft 122 may include electrical leads (e.g., ...) extending along the shaft 122. Figure 1 Any one or more wires 148 shown are used to transmit signals and / or power (e.g., electrical energy) from generator 115 to end portion 124 between end portion 124 and handle 120 and / or interface unit 108.

[0042] Handle 120 may include housing 245 and actuation portion 246. In use, actuation portion 246 may be operated to extend or retract (e.g., contract) deployment member 235 to deploy (e.g., expand, decompress, etc.) or compress distal portion 124 of catheter 104, as described in more detail below. In these and other embodiments, handle 120 may include one or more additional actuation portions (not shown), such as one or more actuation portions operable to deflect distal portion 232 of axis to facilitate positioning distal portion 124 in contact with tissue at the treatment site. Handle 120 may further or alternatively couple to fluid line connection 249 and / or electrical connection 248 for delivering fluid and / or electrical signals (e.g., electrical energy) to / from distal portion 124 along axis 122, respectively.

[0043] Figure 3A and 3B This is a schematic diagram of the end portion 124. As shown, the extendable portion 250 of the end portion 124 can be generally pear-shaped, having a nose portion 355 and a neck portion 357. Figure 3B The expandable portion 250 includes an active body portion 352 (hereinafter referred to as "modular electrode 352"). In other embodiments, the expandable portion 250 may have different general shapes (e.g., spherical, conical, cylindrical, hourglass-shaped, etc.). For example, as described below... Figure 11A –15 To describe in more detail, in some embodiments, the extendable portion 250 of the end portion 124 may be generally “onion-shaped”.

[0044] As shown below Figure 9A –10B describes in more detail that the neck portion 357 of the expandable portion 250 is coupled to the distal portion 232 of the shaft 122 via a coupling member 367 (e.g., mechanical coupling), and the nose portion 355 of the expandable portion is coupled to the unfolding member 235 at the distal portion 240 of the end portion 124 via a coupling member 365 (e.g., mechanical coupling).

[0045] The nasal portion 355 of the distal portion 124 is configured to at least partially fit into the patient 102. Figure 1 The modular electrode 352 is positioned within the pulmonary vein and helps to properly position the modular electrode 352 against the cardiac tissue surrounding the pulmonary vein opening. In some embodiments, the modular electrode 352 (hereinafter referred to as the fully deployed state) is at least in a fully deployed state. Figure 6A and 6B (Description in more detail) has a maximum radial dimension relative to axis 122, which is greater than that of patient 102 ( Figure 1 The maximum radial dimension of the pulmonary vein orifice is used to prevent all or part of the modular electrode 352 from being inserted into the pulmonary vein in at least a fully deployed state. For example, the expandable portion 250 in a fully uncompressed state has an outer diameter greater than about 20 mm and less than about 40 mm (e.g., a diameter between 28 mm and 30 mm, or about 29 mm).

[0046] Figure 4 There is no scalable portion 250 ( Figure 3A and 3B A schematic diagram of the end portion 124 of ). Specifically, Figure 4 This mainly shows a schematic diagram of component 235. Please refer to it together. Figure 3A–4. In some embodiments, the deploying member 235 is coaxial and may be a braided polyimide tube with a polytetrafluoroethylene (PTFE) liner (e.g., to receive guide wire 397). In this respect, the deploying member 235 is an elongating member that has sufficient flexibility to bend with movement of the shaft 122, while having sufficient rigidity to resist buckling, kinking, or other types of deformation that occur in response to forces required to move, expand, or compress the distal portion 124 of the conduit 104. In some embodiments, the braided polyimide tube may additionally or alternatively have a composite PTFE liner to allow smooth movement during the deployment and compression of the expandable portion 250.

[0047] like Figure 4 As shown, the unfolding member 235 may include one or more annular electrodes 434. For example, the unfolding member 235 may include a first annular electrode 434a located near the distal portion 232 of the axis 122 and / or a second annular electrode 434b located near the distal portion 240 of the distal portion 124. In some embodiments, the annular electrodes 434a and / or 434b may be formed of platinum-iridium and / or radiopaque to facilitate fluorescence fluoroscopic visualization and help determine the position, shape, and / or orientation of the distal portion 124 of the catheter 104 when it is within the patient 102. Additionally, or alternatively, the annular electrodes 434a and / or 434b may be passive electrodes configured to measure electrical activity, and / or the annular electrodes 434a and / or 434b may be drive electrodes as part of a grounding circuit and / or an impedance measurement circuit, as described in more detail below.

[0048] Figure 5 This is a top view of the farthest part 240 of the end portion 124. (See also: [link to reference]) Figure 3A –5, the deploying member 235 may define one or more cavities. For example, the deploying member 235 may define a cavity for receiving a guidewire 397 ( Figure 3B and 4 ) cavity 349 ( Figure 3A and 5 This allows the distal portion 124 of catheter 104 to be delivered over-the-wire to the treatment site. Lumen 349 can be configured to receive guidewires 397 of multiple sizes (e.g., guidewires between approximately 0.030” and approximately 0.040”, including 0.032”, 0.035”, and 0.038”). In some embodiments, guidewires 397 can be delivered via handle 120 (… Figure 2 Electrical connector 248 ( Figure 2 ) or fluid connector 249 ( Figure 2The catheter 104 is introduced. In other embodiments, the catheter 104 and / or the deployment member 235 may include a separate guidewire port (not shown) through which the guidewire 397 may be introduced into the catheter 104 and / or the deployment member 235.

[0049] In these and other embodiments, cavity 349 and / or another cavity defined by deployment member 235 may be connected to a fluid delivery device (such as fluid pump 114). Figure 1 The catheter 104 is fluid-connected to deliver fluid (e.g., saline, contrast dye, etc.) to at least the distal portion 124 of the catheter 104. In this regard, the deployment member 235 may be configured to deliver fluid along the length of the axis 122 via the distal portion 124 to the treatment site (e.g., irrigation (cooling) for the modular electrode 352, flushing (washing) of multiple components of the distal portion 124, and / or the positioning of the distal portion 124). For example, the deployment member 235 may deliver fluid from an opening in the lumen 349 at the distal portion 240 of the distal portion 124. Conversely, from the patient 102 ( Figure 1 Blood flowing from the lungs through the pulmonary veins into the left atrium of the patient's heart can carry fluid dispersed from the opening of chamber 349 through and / or near the tissue-contacting exterior of modular electrode 352, thereby facilitating localized heat transfer away from the exterior of modular electrode 352. Generally, it should be understood that this localized heat transfer can reduce the likelihood of blood clotting or carbonization during tissue treatment.

[0050] In these and other embodiments, the deploying member 235 may include holes (not shown) spaced axially and / or circumferentially around the deploying member 235 at the end portion 124 to deliver fluid from within the expandable portion 250 to the treatment site. In some embodiments, the holes may be cut into the deploying member 235 (e.g., using a laser) and / or formed or molded into the deploying member 235 (e.g., using a mechanical punch). The holes in the deploying member 235 may be uniformly distributed along and / or around the deploying member 235 to facilitate guiding fluid toward substantially the entire interior portion of the modular electrode 352 and / or to produce a relatively uniform fluid dispersion along the interior portion of the modular electrode 352. However, it should be understood that the holes in the deploying member 235 may be distributed in any configuration along and / or around the deploying member 235 to facilitate multidirectional dispersion of fluid toward the interior portion of the modular electrode 352.

[0051] As used herein, the term "orifice" should be understood to include discrete orifices of any size and shape through which fluid can flow, having a maximum dimension. Therefore, it should be understood to include any manner and form of substantially geometrically shaped (e.g., substantially circular), and, unless otherwise stated or clearly indicated from the context, also or alternatively, substantially irregular shapes. The size and number of orifices defined by the deploying member 235 are selected such that the fluid pressure in the respective cavities of the deploying member 235 is sufficient to prevent blood from entering the orifice. For example, to provide some margin of variation in fluid pressure, the size and number of orifices defined by the deploying member 235 may be selected such that the fluid pressure in the deploying member 235 is at least about 0.5 psi higher than the blood pressure of the patient 102.

[0052] The deployable member 235 may be spaced apart from the inner portion of the expandable portion 250, such that the orifice guides fluid toward at least the inner portion of the modular electrode 352 in an expanded state (e.g., in an uncompressed or deployed state). For example, in the deployed state of the modular electrode 352, fluid exits the orifice defined by the deployable member 235 and is guided toward the inner portion of the modular electrode 352, while the outer portion of the modular electrode 352 (opposite to the inner portion) contacts tissue as part of a diagnosis and / or as part of an ablation or other treatment. The spacing between the orifice in the deployable member 235 and the inner portion of the modular electrode 352 may facilitate heat transfer between the fluid and the modular electrode 352. Additionally or alternatively, blood may flow through the spacing between the orifice in the deployable member 235 and the inner portion of the modular electrode 352. Blood flow through the spacing between the orifice in the deployable member 235 and the inner portion of the modular electrode 352 may additionally or alternatively further improve local heat transfer away from the outer portion of the modular electrode 352 compared to a configuration where blood flow away from the treatment site is obstructed. Generally speaking, it should be understood that this improved local heat transfer can reduce the likelihood of accidental tissue damage during tissue treatment.

[0053] like Figure 4 As shown, the deployable member 235 is telescopic (e.g., the deployable member 235 includes a plurality of concentric tubular components), such that the distal portion 240 of the end portion 124 can extend and / or retract (e.g., shrink) relative to the distal portion 232 of the shaft 122. The telescopic feature of the deployable member 235 facilitates the deployment and compression of the expandable portion 250 of the end portion 124. For example, because the deployable member 235 is mechanically coupled to the expandable portion 250 at the distal portion 240 of the end portion 124 via a coupling member 365, axial movement of the deployable member 235 relative to the shaft 122 can apply compressive and / or expansion forces to the expandable portion 250.

[0054] Figure 6A and 6BThese are schematic diagrams of the expandable portion 250 in its compressed and expanded states, respectively. Starting with the expandable portion 250 in its compressed state ( Figure 6A The proximal movement of the unfolding member 235 (retraction / contraction of the extendable feature) can pull the distal end of the extendable portion 250 in the proximal direction relative to the axis 122, causing the extendable portion 250 to extend into an uncompressed or unfolded state. Figure 6B The expanded state of the expandable portion 250 can be used for treatment, diagnosis, or both of the tissue at the treatment site. Furthermore, or alternatively, distal movement of the expanding member 235 (an extension of the retractable feature) can push the distal end of the expandable portion 250 in the distal direction relative to the axis 122, such that the expandable portion 250 moves from the expanded state ( Figure 6B ) collapsed into a compressed state ( Figure 6A The compressed state of the expandable portion 250 can be used to retract, deliver, or both of the distal portion 124 to the treatment site. In some embodiments, the unfolding member 235 may be mechanically coupled to a portion of the handle 120 (e.g., Figure 2 The actuating part 246 shown allows the movement of the unfolding member 235 to be controlled at the handle 120.

[0055] In some embodiments, at least a portion of the interior portion of the modular electrode 352 along the expandable portion 250 is closer to the surface of the unfolded member 235 in the compressed state than in the uncompressed state, and therefore, as the expandable portion 250 moves from the compressed state ( Figure 6A Expand to uncompressed state ( Figure 6B The internal portion of the modular electrode 352 is movable away from at least a portion of the surface of the deployable member 235. It should be understood that different degrees of compression and expansion of the expandable portion 250 can be achieved, respectively, via different degrees of proximal and distal movement of the deployable member 235. For example, the expandable portion 250(i) can be further compressed via additional distal movement (extension) of the deployable member 235. Figure 6A As shown, (ii) it can be further expanded via additional proximal movement (retraction) of the deploying member 235. Figure 6B As shown, and / or (iii) may be decompressed or compressed via axial movement of the unfolding member 235. Figure 6A and 6B Between one or more states shown, the unfolding member 235 sets the position of the farthest portion 240 of the end portion 124. Figure 6A and 6BThe distal portion 240 of the distal portion 124 shown is positioned between these locations. In some embodiments, the extendable portion 250 can extend to the nasal portion 355, the distal portion of the active body portion 352, or both, forming substantially perpendicular to the unfolding member 235 and being positioned relative to the distal surface of the tissue (e.g., around the pulmonary vein orifice).

[0056] Scalable part 250 ( Figure 3A and 3B It is a discontinuous structure composed of multiple mesh electrode plates. For example, Figure 7A and 7B This is a schematic diagram of a standalone mesh electrode plate 750, which can be combined with other plates 750 to form an expandable portion 250. For example, as... Figure 7A and 7B As shown, each mesh electrode plate 750 includes a plurality of pillars 751, 755, and 757. All or a portion of the pillars 751 form an active portion 752 of the plate 750 through which energy can be delivered to the tissue. As shown, the active portion 752 of the plate is much wider than the portion of the plate 750 formed by the pillars 757 and 755. Conversely, all or a portion of the pillars 757 of each mesh electrode plate 750 is insulated, such that electricity cannot be delivered to the tissue through the insulated portion of the pillar 757. In the illustrated embodiment, all or a portion of the pillars 755 of each mesh electrode plate 750 is also insulated, such that electricity cannot be delivered to the tissue through the insulated portion of the pillar 755. Alternatively or additionally, all or a portion of the pillars 755 may form a portion of the active portion 752 of the plate 750 through which energy can be delivered to the tissue. In some embodiments, the pillars 755 and / or 757 may be insulated using PTFE tubing or other polymers (e.g., polyimide and / or Pebax®). However, in other embodiments, the supports 755 and / or 757 may be insulated using adhesives or other suitable materials.

[0057] Plate 750 may be formed from a sheet or tube of material that is reproducibly and durablely flexible between compressed and uncompressed states (e.g., laser-cut, 3D-printed, chemically etched, etc.). In some embodiments, the material may be at least (e.g., semi- or completely) radiopaque to facilitate visualization of the material when it is within the patient 102. An example of a material that meets one or both of the above criteria is nitinol. After each mesh electrode plate 750 is formed from this material, one or more surfaces of plate 750 may be electropolished. For example, such electropolishing may be used to smooth the surface and / or otherwise fine-tune the amount of material used to form each plate 750. Additionally or alternatively, the material used to form each mesh electrode plate 750 may be coated with one or more of gold, tantalum, iridium oxide, or other materials. Thus, continuing with the example above, all or a portion of the active portion 752 of the mesh electrode plate 750 may optionally be coated to deliver electrical energy to tissue.

[0058] The struts 751 of each mesh electrode plate 750 can be mechanically coupled to each other to collectively define a plurality of units 753. Thus, each unit 753 can be defined by at least three struts 751 (e.g., by at least four struts 751). Furthermore, or alternatively, each strut 751 can define a portion of at least one of the units 753. In some embodiments, the units 753 can be defined by a different number of struts 751, which can facilitate the implementation of a plurality of units along the expandable portion 250 when the plates 750 are mechanically coupled to each other. Figure 2 The target distribution of current density (-3B) is as follows regarding... Figure 8A –8D provides a more detailed description.

[0059] Additionally, or alternatively, at least some of the struts 751 may (a) be coupled to struts 757 to transition between a portion of the modular electrode 352 of the plate 750 corresponding to the expandable portion 250 and a portion of the neck portion 357 of the plate 750 corresponding to the expandable portion 250, and (b) be coupled to struts 755 to transition between a portion of the modular electrode 352 of the plate 750 corresponding to the expandable portion 250 and a portion of the nose portion 355 of the plate 750 corresponding to the expandable portion 250. For example, an electrode plate 750 configured according to various embodiments of the present technology may include at least one strut 757 (e.g., a single strut 757) to form at least a portion of the neck portion 357 of the expandable portion 250. The proximal (e.g., proximal side) portion of the strut 757 may be mechanically coupled to the distal portion 232 of the shaft 122. The proximal (e.g., nearest-side) portion of the first pillar 751 may be coupled to the pillar 757 (e.g., coupled to the distal and / or furthest portions of the pillar 757), and the proximal (e.g., nearest-side) portion of the second pillar 751 may be coupled to the pillar 757 (e.g., coupled to the distal and / or furthest portions of the pillar 757). Therefore, in some embodiments, the pillars 757 of the electrode plate 750, as well as the first and second pillars 751, may form a “Y” shape at the transition between a portion of the neck portion 357 of the plate 750 corresponding to the expandable portion 250 and a portion of the modular electrode 352 of the plate 750 corresponding to the expandable portion 250.

[0060] Alternatively or concurrently, the electrode plate 750 configured according to various embodiments of the present technology may include at least one pillar 755 (e.g., a single pillar 755) to form at least a portion of the nose portion 355 of the expandable portion 250 (and / or at least a portion of the modular electrode 352, as described below). Figure 11A –14C (discussed in more detail). The distal (e.g., furthest) portion of the strut 755 may be mechanically coupled to the furthest portion 240 of the end portion 124. The distal (e.g., furthest) portion of the first strut 751 may be coupled to the strut 755 (e.g., coupled to the proximal and / or nearest-side portion of the strut 755), and the distal (e.g., furthest) portion of the second strut 751 may be coupled to the strut 755 (e.g., coupled to the proximal and / or nearest-side portion of the strut 755). Thus, in some embodiments, the struts 755 of the electrode plate 750, as well as the first strut 751 and the second strut 751, may form a “…” at or near the transition between a portion of the nose portion 355 (and / or modular electrode 352) of the plate 750 corresponding to the expandable portion 250 and a portion of the modular electrode 352 of the plate 750 corresponding to the expandable portion 250. "shape.

[0061] In these and other embodiments, at least some of the units 753 of the plate 750 are symmetrical. For example, such symmetry can help achieve a targeted distribution of current density along the modular electrode 352. Alternatively or additionally, this symmetry can be used to achieve suitable compressibility of the expandable portion 250 for delivery to the treatment site, while also enabling suitable expansion of the expandable portion 250 for use at the treatment site.

[0062] In some embodiments, at least some units 753 may have mirror symmetry. As used herein, a mirror-symmetric shape includes a shape substantially symmetrical about a plane intersecting the shape, which allows for the presence or absence of an eyelet 758 on one or both sides of the plane intersecting the shape. For example, at least some units 753 may have mirror symmetry about a corresponding mirror-symmetric plane that passes through the corresponding unit 753 and includes an axis 122 ( Figure 1 and 2 The central axis is defined and extends from the proximal portion to the distal portion of the shaft 122. Additionally or alternatively, it should be understood that the entire expandable portion 250 of the distal portion 124 ( Figure 3A and 3B The scalable portion 250 can be symmetrical about one or more planes including the central axis. The symmetry of the scalable portion 250 can, for example, facilitate the symmetrical delivery of energy to tissues at multiple locations surrounding the scalable portion 250.

[0063] Mirror symmetry of at least some of the elements in the plurality of elements 753 and / or the entire scalable portion 250 can be useful, for example, to achieve a targeted distribution of current density. Additionally or alternatively, symmetry can contribute to the expansion and contraction of the scalable portion 250 in a predictable and repeatable manner (e.g., with minimal plastic deformation). For example, each element in the plurality of elements 753 can be symmetric about its corresponding plane of symmetry in both the compressed and uncompressed states of the scalable portion 250.

[0064] At least some of the multiple units 753 may be flexible in the axial and lateral directions, such that the open frame formed by the multiple units 753 along the expandable portion 250 has similar flexibility when the multiple plates 750 are mechanically coupled together, as described in more detail below. For example, at least some of the multiple units may be substantially rhomboid in the uncompressed state of the expandable portion 250. As used herein, a substantially rhomboid shape includes a shape having a first pair of joints substantially aligned along a first axis and a second pair of joints substantially aligned along a second axis different from the first axis (e.g., perpendicular to the first axis).

[0065] exist Figure 7A and 7BIn the illustrated embodiment, the length of the strut 751 decreases in the direction from the proximal region of the plate 750 (near strut 757) to the distal region of the plate 750 (near strut 755), which helps to form the general "pear-shaped" shape of the expandable portion 250 when the multiple plates 750 are mechanically coupled to each other. However, in other embodiments, the length of the strut 751 may be uniform, increasing, or non-monotonically varying on the mesh electrode plate 750 in the same or similar direction (from the proximal region of the plate 750 to the distal region of the plate 750), for example, helping to form another general shape of the expandable portion 250 (e.g., an "onion" shape). Additionally or alternatively, the bottom portion of the plate 750, which includes a subset of struts 751 corresponding to the modular electrodes 352 of the expandable portion 250, may be wider than the top portion of the plate 750, which includes a different subset of struts 751 corresponding to the modular electrodes 352 of the expandable portion 250 (e.g., helping to form the general shape of the expandable portion 750 when the multiple plates 750 are mechanically coupled to each other).

[0066] In these and other embodiments, the widths of the struts 751, 755, and / or 757 can vary (e.g., across a single strut 751, 755, and / or 757, and / or across multiple struts 751, 755, and / or 757). Different widths of the struts 751, 755, and / or 757 can help provide desired stiffness at a given location on the plate 750. For example, the widths of the struts 755 and / or 757 can be greater than the width of the strut 751, making the active portion 352 of the plate 750 formed by the struts 751 more flexible than the struts 755 and / or 757. Continuing this example, when multiple plates 750 are mechanically coupled to each other (as described in more detail below), the modular electrode 352 of the scalable portion 250 formed by the active portion 352 of the plate 750 can be more flexible (e.g., more conformal) than the neck portion 357 formed by the struts 757 and / or the nose portion 355 formed by the struts 755. In these and other embodiments, the nose portion 355 formed by the strut 755 may be more flexible than the neck portion 357 formed by the strut 757, thereby allowing the nose portion 355 to extend further relative to the unfolding member 235 than the neck portion 357 as the expandable portion 250 is deployed (e.g., extended). In some embodiments, the width of the strut 757 may vary. For example, the strut 757 may include a first portion having a first width and a second portion having a second width less than the first width to facilitate bending (e.g., along the second portion, at the transition between the first and second portions, etc.). Additionally or alternatively, the length of the struts 755 and / or 757 may be greater than the length of the strut 751.

[0067] For example Figure 7A and 7BAs shown, material removed from the sheet or tube can define a keying portion 794 at the ends of the supports 755 and 757. As discussed in more detail below, the keying portions 794 of the supports 755 and 757 facilitate the connection of the plate 750 to the distal portion 232 of the unfolding member 235 and the shaft 122, respectively.

[0068] Alternatively or additionally, the material removed from the sheet or tube may define an eyelet 758 at one end of at least some of the supports 751. The eyelet 758 may, for example, be defined at the intersection of two or more supports and may be used to couple (e.g., mechanically couple) a plurality of mesh electrode plates 750 to each other. Figure 7A and 7B Each of the illustrated plates 750 includes four eyelets 758, with two eyelets 758 located on each side of the axis extending from post 757 to post 755. However, in other embodiments, the plate 750 may include fewer (e.g., one, two, or three) or more (e.g., five or more) total number of eyelets, and / or fewer (e.g., zero or one) or more (e.g., three or more) number of eyelets located on any side of the axis extending from post 757 to post 755. In these and other embodiments, the plate 750 may include... Figure 7A and 7B Holes 758 at locations other than those shown in the illustrated embodiment. For example, at least one of the holes 758 may be located between the ends of one of the supports 751.

[0069] Figure 8A –8D schematically illustrates how the mesh electrode plate 750 is attached to form an expandable portion 250 of the end portion 124. (See diagram below.) Figure 8AAs shown in –8C, the eyelets 758 of adjacent mesh electrode plates 750 are aligned (overlapping) and held together by fasteners 870. In the illustrated embodiment, the fastener 870 is a rivet having a main head 871. In this embodiment, the eyelets 758 of adjacent mesh electrode plates 750 can, for example, be aligned with each other such that the main head 871 of the fastener 870 passes through the aligned eyelets 758. The main head 871 is hollow (at least partially) such that the bottom portion 871a of the main head 871 can flare outward to hold the fastener 870 within the eyelet 758 and hold the plates 750 together by the force applied by the fastener 870 to the corresponding eyelet 758. In other embodiments, different types of fasteners 870 may be used (e.g., double-ended rivets, coiled pieces, flange screws and washers, PEM® fasteners, etc.). In some embodiments, the fastener 870 may be formed of a material different from the material used to form the mesh electrode plates 750 (e.g., a polymer such as polyetheretherketone (PEEK)). As described in more detail below, at least some of the fasteners 870's main heads 871 may accommodate and / or include sensors 826, which may be connected to the interface unit 108 via one or more electrical leads 806. Figure 1 ) and / or generator 115 ( Figure 1 Electrical connection, the one or more electrical leads 806 along axis 122 ( Figure 1 and 2 ) and / or handle 120 ( Figure 1 and 2 (The length extension of)

[0070] A polymer disk 872, formed of an electrically insulating material (e.g., any of a variety of different biocompatible polymers, such as polyimide), is used to separate and electrically isolate adjacent mesh electrode plates 750 from each other and / or from the sensor 826 included in the fastener 870. In the illustrated embodiment, the polymer disk 872 is shown as a single disk. In other embodiments, one or more polymer disks 872 may form a single integrated insulating element. In these and other embodiments, a portion of electrical leads 806 (e.g., flexible printed circuitry) may electrically isolate adjacent mesh electrode plates 750 from each other and / or from the sensor 826 included in the fastener. In some embodiments, a portion of the electrical leads 806 may replace the polymer disk 872 (e.g., Figure 8A The top polymer disc 872 is shown between the main head 871 of the fastener 870 and the eyelet 758 of the top plate 750.

[0071] Alternatively or alternatively, a loop 873 may be disposed in the orifice of aligned eyelets 758 between the sensor 826 and the plate 750. The loop 873 may be formed, for example, of an electrically insulating material (e.g., any of a variety of different biocompatible polymers). In this way, the loop 873 can electrically isolate the sensor 826 from the mesh electrode plate 750. Alternatively or alternatively, the loop 873 may be formed of a flexible material to facilitate, for example, press-fitting the loop 873 and the sensor 826 through the orifice. In some embodiments, the loop 873 may include an outwardly flaring bottom portion (not shown) (e.g., to hold the loop 873 in place to provide electrical insulation, etc.). Alternatively or alternatively, the loop 873 may include a bottom flange portion (not shown). In some embodiments, the bottom flange portion may replace the polymer disc 872 (e.g., the bottommost polymer disc 872, Figure 8A The polymer disc 872 (or a portion of the polymer disc 872 / insulator shown between the apertures 758) is generally used to reduce the likelihood that mounting the sensor 826 in the apertures would interfere with the operation of the sensor 826. For example, the grommets 873 can facilitate mounting the sensor 826 to the plate 750 of the expandable portion 250 without requiring physical modifications to the sensor 826 (e.g., drilling).

[0072] A seal 874 may be formed over the back of the fastener 870 and / or the sensor 826 (e.g., to electrically insulate a portion of the non-contact tissue of the sensor 826, to electrically insulate the sensor 826 from the plate 750, and / or to electrically isolate the plates 750 from each other). In some embodiments, the seal 874 may be an in-situ cured adhesive. In other embodiments, the seal 874 may be reflow thermoplastic or other insulators.

[0073] In some embodiments, at least one of the fasteners 870 does not house or includes the sensor 826. Such fasteners 870 may be formed of a material different from the material used to form the mesh electrode plates 750 (e.g., a polymer such as PEEK). In these embodiments, one or more polymer discs 872 (e.g., polymer discs 872 positioned between the eyelets 758 of adjacent electrode plates 750 and used to electrically isolate the plates 750 from each other), grommets, and / or seals 874 may be omitted from fasteners 870 that do not include the sensor 826.

[0074] As shown below Figure 14A–14C describes in more detail that, in some embodiments, one or more pillars 751 of at least one plate 750 may include one or more features (e.g., one or more bends) near one or more corresponding eyelets 758. Such features can facilitate the recessing of one or more corresponding sensors 826 relative to the exterior of the expandable portion 250 when the corresponding plates 750 are attached to each other. This can be advantageous, for example, allowing the expandable portion 250 to smoothly enter and exit the guide sheath (e.g., without one or more corresponding sensors 826 being stuck on the lip of the guide sheath at one or more openings in the sheath).

[0075] Despite the 750 Figure 7A –Drawn in –8D as having one or more eyelets 758 that facilitate mechanical coupling of the plates 750 to each other, however, in other embodiments, the plates 750 and / or the expandable portion 250 may include other attachment means besides or in place of the eyelets 758 for mechanically coupling the plates 750 to each other. For example, an external connector of one or more units 753 along the periphery of a plate 750 may be mechanically coupled using fasteners to a corresponding external connector of one or more units 753 along the periphery of another plate 750 (e.g., using a figure-eight non-conductive fastener passing through units 753 on the periphery of each plate 750, using a non-conductive fastener woven back and forth between the plates 750 from post 755 to post 757 (and / or vice versa) passing through one or more units 753 on the periphery of each plate 750, etc.). In some embodiments, independent of the method of coupling the plates 750 to each other, an insulating material (e.g., grommets, sleeves, adhesives, dipcasts, heat-shrinkable, reflow thermoplastics, or other suitable materials) may be applied to the posts 751 and / or the eyelets 758 to provide additional electrical insulation between adjacent mesh electrode plates 750.

[0076] Now for reference Figure 8D When multiple (e.g., two, three, four, five, six, or more (e.g., seven to twelve)) mesh electrode plates 750 are mechanically coupled to each other, the plates 750 collectively form a closed shape to define the expandable portion 250. In the illustrated embodiment, six mesh electrode plates 750 form a pear-shaped expandable portion 250. Specifically, all or part of the pillars 751 of the plates 750 form modular electrodes 352 of the expandable portion 250. Additionally, as described in more detail below, the pillars 755 of the plates 750 form the nose portion 355 of the expandable portion 250, and the pillars 757 of the plates 750 form the neck portion 357 of the expandable portion 250.

[0077] As shown, the central portion of the expandable portion 250 corresponding to the modular electrode 352 is larger than the first portion of the neck portion 357 corresponding to the expandable portion 250 and / or the nose portion 355 corresponding to the expandable portion 250 (and / or a portion of the modular electrode 352, as described below). Figure 11A The second part (discussed in more detail in –14C) is much wider. Alternatively or additionally, the expandable part 250 includes a greater number of units 753 around the equator than around the first and / or second parts.

[0078] As shown, the multiple units 753 of the expandable portion 250 are defined by at least four pillars (e.g., pillar 751, pillar 757, and / or pillar 755). Several units 753 are each defined by pillars of different (e.g., adjacent) electrode plates 750 (e.g., by pillar 751, pillar 757, and / or pillar 755). For example, the unit 753 of the expandable portion 250 at the nose portion 355 is defined by pillar 755 and at least one pillar 751 of the first plate 750, and pillar 755 and at least one pillar 751 of the second (e.g., adjacent) plate 750. Similarly, the unit 753 of the expandable portion 250 at the neck portion 357 is defined by pillar 757 and at least one pillar 751 of the first plate 750, and pillar 757 and at least one pillar 751 of the second (e.g., adjacent) plate 750. As yet another example, the unit 753 of the expandable portion 250 at the modular electrode 352 is defined by at least one pillar 751 of the first plate 750 and at least one pillar 751 of the second (e.g., adjacent) plate 750.

[0079] In the uncompressed state, support 751, eyelet 758 ( Figure 8D The diagram shows an open frame formed together with fasteners 870 and units 753 formed by pillars 751, having a conductive surface covering at least a portion of the modular electrode 352 along the expandable portion 250. For example, the open frame formed by pillars 751, eyelets 758, and units 753 may have an open area greater than about 50% along the outer portion of the modular electrode 352 when the expandable portion 250 is in an uncompressed state. Continuing this example, in the uncompressed state, the combined open area of ​​units 753 may be greater than the combined area of ​​pillars 751 and eyelets 758 along the outer portion of the modular electrode 352. Further, or alternatively, at least some units 753 may have a larger area in the uncompressed state of the expandable portion 250 than in the compressed state of the expandable portion 250.

[0080] As discussed above, the expandable portion 250 can be expanded (e.g., deployed) and compressed via proximal and axial movement of the deployable member 235, respectively. To facilitate the movement of the expandable portion 250 from a compressed state to an deployed state (and vice versa), the struts 751 of each plate 750 can be flexible relative to each other. For example, without external forces, the maximum radial dimension of the modular electrode 352 (alternately referred to herein as the lateral dimension) can increase by at least two times as the coupled struts 751 move relative to each other to convert the expandable portion 250 from a fully compressed state to a fully uncompressed state. Additionally or alternatively, the struts 751 can move relative to each other such that the maximum radial dimension of the expandable portion 250 in the uncompressed state is at least about 20% larger than the maximum radial dimension of the shaft 122 (e.g., the maximum radial dimension of the distal portion 232 of the shaft 122). For example, Figure 8D The expandable portion 250 shown in its uncompressed state has an outer diameter greater than about 20 mm and less than about 40 mm (e.g., between 28 mm and 30 mm, or about 29 mm), while the shaft 122 has an outer diameter greater than about 1.5 mm and less than about 7 mm (e.g., between 2 mm and 3.5 mm, or about 2.7 mm). The increased size is achieved by using an open frame of unit 753 formed by struts 751, which uses less material than a solid shape of the same size would require.

[0081] In some embodiments, the expandable portion 250 may take on its expanded (e.g., pear-shaped) shape without external force. For example, the expandable portion 250 may take on its unfolded shape when it is not mechanically coupled (e.g., not tethered) to the distal portion 240 of the distal portion 124, to the distal portion 232 of the shaft 122, and / or to another portion of the catheter; and / or when no other compressive force is acting on the expandable portion 250. In some embodiments, the diameter of the expanded or unfolded shape may be greater than the maximum diameter of the catheter shaft 122.

[0082] It should be understood that the open area of ​​the expandable portion 250 can facilitate the flow of fluid and blood through the expandable portion 250 during treatment. In other words, the internal portion of the modular electrode 352 can be fluidly communicated with the external portion of the modular electrode 352 through multiple units 753, such that during use, fluid, blood, or a combination thereof can move through the multiple units 753 to cool the modular electrode 352 and the tissue near the modular electrode 352. Compared to electrodes that obstruct blood flow, the open area of ​​the expandable portion 250 can reduce the likelihood of localized heating of the blood at the treatment site when energy is delivered to the tissue. Furthermore, compared to electrodes that obstruct blood flow, the open area of ​​the expandable portion 250 can reduce the likelihood of blood clotting or clot formation, thereby reducing the likelihood of thromboembolism. It should also be understood that delivering fluid to the internal portion of the modular electrode 352 can enhance cooling that would occur solely through the flow of blood through the open area.

[0083] As discussed above, the pillars 755 of the plate 750 together form the nose portion 355 of the expandable portion 250, and the pillars 757 of the plate 750 together form the neck portion 357 of the expandable portion 250. Figure 9A –10B illustrates how the mesh electrode plate 750 of the expandable portion 250 is attached to the deployable member 235 (e.g., Figure 9A and 9B (as shown) and the distal portion 232 of shaft 122 (as shown) Figure 10A and 10B (As shown).

[0084] First refer to Figure 9A and 9B The coupling member 365 at the farthest part 240 of the end portion 124 couples the support 755 to the deployment member 235. Figure 9A In some embodiments, the coupling member 367 is a machined hard insulator, such as a PEEK coupling member. In the illustrated embodiment, the coupling member 365 includes a first portion 965a and a second portion 965b. The first portion 965a includes a recess configured to receive a corresponding keyed portion 794 of the strut 755. The recessed portion of the first portion 965a of the coupling member 365 prevents axial movement (within machining tolerances) of the keyed portion 794 of the strut 755 relative to the distal end portion 240 of the end portion 124. The second portion 965b of the coupling member 365 is fitted over the first portion 965a to hold the keyed portion 794 of the strut 755 within the recessed portion of the first portion 965a.

[0085] In other embodiments, the strut 755 may be coupled to the distal portion 240 of the end portion 124 using other types of couplings 365. For example, the end of the strut 755 may include an aperture configured to receive a centering pin or rivet of the coupling 365. In these embodiments, the coupling 365 may include a corresponding second portion configured to receive and retain the centering pin or rivet to align the end of the strut 755 with the second portion and hold the end of the strut 755 in place. Other examples of couplings 365 within the scope of this art include heat fusion, crimping, ultrasonic welding, or reflow soldering to hold the end of the strut 755 in place.

[0086] As discussed above, in the illustrated embodiment, all or part of the support 755 is insulated. Figure 9A As shown, the support 755 includes an insulator 993 (e.g., polyethylene terephthalate (PET) or PTFE sheath) covering most of the support 755. In some embodiments, the insulator 993 terminates before the bonding portion 794 of the support 755. In other embodiments, the insulator 993 extends to and / or coats all or part of the bonding portion 794. Additionally or alternatively, the coupling 365 may include an insulating material to prevent electrical connections between the mesh electrode plates 750.

[0087] Now for reference Figure 10A and 10B The coupling element 367 couples the support 757 of the mesh electrode plate 750 to the distal portion 232 of the shaft 122. In some embodiments, the coupling element 367 is a machined hard insulator, such as a PEEK coupling element.

[0088] In the illustrated embodiment, the coupling element 367 includes a first portion 1067a ( Figure 10A ) and Part 1067b ( Figure 10B The first portion 1067a includes a recess configured to receive a corresponding keyed portion 794 of the strut 757. The recess of the first portion 1067a of the coupling member 367 prevents axial movement (within machining tolerances) of the keyed portion 794 of the strut 755 relative to the distal portion of the shaft 122. The second portion 1067b of the coupling member 367 is fitted over the first portion 1067a to hold the keyed portion 794 of the strut 757 within the recess of the first portion 1067a.

[0089] In other embodiments, the strut 757 may be coupled to the distal portion 232 of the shaft 122 using other types of couplings 367. For example, the end of the strut 757 may include a hole configured to receive a centering pin or rivet of the coupling 367. In these embodiments, the coupling 367 may include a corresponding second portion configured to receive and retain the centering pin or rivet to align the end of the strut 757 with the second portion and hold the end of the strut 757 in place. Other examples of couplings 367 within the scope of this art include heat fusion, crimping, ultrasonic welding, or reflow soldering to hold the end of the strut 757 in place.

[0090] As discussed above, all or part of the support 757 is insulated. Figure 10A As shown, the support 757 includes an insulator 1093 (e.g., a PTFE sheath) covering most of the support 757. In some embodiments, the insulator 1093 terminates before the bonding portion 794 of the support 757. In other embodiments, the insulator 1093 extends to and / or coats all or part of the bonding portion 794. Additionally or alternatively, at least a portion of the coupling 367 may include an insulating material to prevent electrical connections between the mesh electrode plates 750.

[0091] Coupler 367 may include one or more electrical leads or wires 148 ( Figure 1 ) and / or other conductive paths extending along the length of axis 122 from generator 115 electrically coupled to generator 115 ( Figure 1 The electrical contacts of the generator 115. In these and other embodiments, when the strut 757 is secured within the coupling member 367, each strut 757 may be electrically coupled directly or indirectly to the generator 115 via one or more electrical contacts of the coupling member 367 and / or via one or more electrical leads or wires 148 and / or other conductive paths extending from the generator 115 along the length of the axis 122. Figure 1 In this way, as described in more detail below, electrical energy supplied by generator 115 can be individually delivered via the struts 757 of plate 750 to the struts 751 of each mesh electrode plate 750 of expandable portion 250, wherein electrical energy can be delivered to the tissue of patient 102 via the corresponding portions of modular electrode 352.

[0092] Refer again Figure 8A –8D, the sensor 826 can be mounted along the modular electrode 352 of the expandable portion 250 at all or a subset of locations where adjacent mesh electrode plates 750 are mechanically coupled to each other through eyelets 758 and fasteners 870. Generally, the sensor 826 can be positioned along one or both of the inner and outer portions of the modular electrode 352.

[0093] Each sensor 826 may be electrically insulated from the plate 750 and mounted on and / or within the fastener 870. For example, each sensor 826 may be mounted to the fastener 870 using a compliant adhesive (e.g., epoxy or room temperature vulcanizing (RTV) silicone), any of a plurality of different mechanical retaining features (e.g., tabs) between the sensor 826 and the fastener, and / or by molding or overmolding the sensor 826 to the fastener 870. Alternatively, the sensor 826 may extend through a portion of the fastener 870 and / or through an eyelet 758 in the plate 750. This positioning of the sensor 826 through a portion of the fastener 870 can facilitate the formation of a robust mechanical connection between the sensor 826 and the fastener 870. Alternatively, positioning the sensor 826 through a portion of the fastener can facilitate the measurement of conditions along both the outer and inner portions of the modular electrode 352.

[0094] Electrical leads 806 extend from each sensor 826 inside or along the expandable portion 250 and into the shaft 122. Figure 2 Electrical lead 806 may include wires (e.g., insulated wires) or printed circuitry (e.g., flexible printed circuitry) or combinations thereof. Electrical lead 806 interacts with interface unit 108. Figure 1 ) and / or generator 115 ( Figure 1 Electrical connectivity allows each sensor 826 to send electrical signals to and receive electrical signals (e.g., electrical energy) from the interface unit 108 and / or generator 115 during use. See below for details. Figure 13 To discuss in more detail, one or more additional sensors ( Figure 1 –10B (not shown) can be formed by one or more electrical leads 806 and / or positioned on one or more electrical leads 806 such that one or more additional sensors are held inside the expandable portion 250 and do not contact the tissue when the expandable portion 250 contacts the tissue.

[0095] When the expandable portion 250 is in an uncompressed state, the sensors 826 can be spaced substantially uniformly from each other (e.g., circumferentially and / or axially) along the modular electrodes 352 of the expandable portion 250. This substantially uniform distribution of the sensors 826 can, for example, help determine the shape (e.g., the degree of expansion and / or deformation) and / or temperature profile of all or part of the modular electrodes 352 during use. For example, the sensors 826 can be electrically isolated from the modular electrodes 352, wherein the sensors 826 (acting as surface electrodes) passively detect the electrical activity of tissue near each respective sensor 826 without interference from the modular electrodes 352. At least some sensors 826 may be disposed at least partially along the outer portion of the expandable portion 250, wherein the expandable portion 250 is between one or more internal electrodes (e.g., ring electrodes 434a, ring electrodes 434b, and / or one or more additional sensors formed by and / or positioned on one or more electrical leads 806) and at least a portion of each corresponding sensor 826 along the outer portion. Additionally or alternatively, at least some sensors 826 may extend through the modular electrode 352. In these embodiments, one or more sensors 826 may be insulated along the inner portion of the expandable portion 250 and / or exposed along the outer portion of the expandable portion 250. Furthermore, or alternatively, at least some sensors 826 may be disposed at least partially along the inner portion of the expandable portion 250 and / or exposed. In such an implementation, each sensor 826 may be near the tissue without contacting it when the modular electrode 352 contacts the tissue.

[0096] Each sensor 826 may act as an electrode (e.g., a surface electrode) to detect electrical activity of the heart in a localized region of the sensor 826. In some embodiments, one or more sensors 826 may be coated with platinum black or iridium oxide (e.g., to reduce impedance or noise). Additionally or alternatively, each sensor 826 may include a temperature measuring device (e.g., a thermocouple or a thermistor). For example, sensor 826 may include a flexible printed circuit, a temperature measuring device fixed between portions of the flexible printed circuit, and a terminal pad opposite the temperature measuring device. Continuing this example, sensor 826 may be mounted on fastener 870, with the thermistor positioned along the outer portion of the expandable portion 250 and the terminal pad positioned along the inner portion of the expandable portion 250. In some cases, the thermistor may be positioned along the outer portion to provide an accurate representation of tissue temperature. Thermally conductive adhesive or other conductive material may be disposed over the thermistor to secure it to the flexible printed circuit. In these and other embodiments, one or more sensors 826 may include an ultrasonic transducer, fiber optic, and / or other types of image sensors. As another example, sensor 826 may include a flexible printed circuit having two or more electrodes, one of which is disposed along an external portion of expandable portion 250. As yet another example, sensor 826 may include a thermocouple formed within sensor 826 (e.g., within a flexible printed circuit including, for example, constantan and copper traces) at a junction of two metals or at an electrical connection point between sensor 826 and electrical lead 826.

[0097] In some embodiments, each sensor 826 may be formed of and / or include a radiopaque material. The radiopacity of sensor 826 can, for example, aid in visualization of sensor 826 during use (e.g., using fluorescence permeation). Examples of radiopaque materials that can be formed of and / or added to sensor 826 include platinum, platinum-iridium, gold, radiopaque inks, and combinations thereof. Radiopaque materials can be formed of and / or added in any pattern that may aid in visualization of the radiopaque material (e.g., dots and / or rings).

[0098] In some embodiments, each sensor 826 may form part of an electrode assembly for detecting contact between each sensor 826 and tissue. For example, electrical energy (e.g., current) may be driven by each sensor 826 and another electrode or a plurality of other electrodes (e.g., any one or more of the plurality of different electrodes described herein), and changes in the measured signal (e.g., voltage or impedance) may indicate the presence of tissue. Because the location of the distal portion 124 is known, contact detection via the corresponding measured signal at sensor 826 is useful for determining the shape of the anatomical structure in which the distal portion 124 is disposed and / or its tissue mating / contact with the distal portion 124 during a medical procedure. Additionally or alternatively, the measured signal at sensor 826 may be used to determine the position of the guide sheath relative to the distal portion 124, for example, by detecting an increase in the measured signal (e.g., voltage or impedance) when the sensor is covered by the sheath, indicating that the sheath at least partially covers the distal portion 124.

[0099] In use, each sensor 826 may further or alternatively act as an electrode to detect electrical activity in a local cardiac region of the corresponding sensor 826, wherein the detected electrical activity forms the basis of an electrogram associated with the corresponding sensor 826, and further or alternatively, may provide damage or other feedback. The sensors 826 may be arranged such that the electrical activity detected by each sensor 826 can form the basis of a unipolar electrogram and / or a bipolar electrogram. For example, in embodiments where one or more additional sensors are formed by and / or located on one or more electrical leads 806, the sensor 826 may cooperate with the additional sensors to form one or more bipolar electrograms. Additionally or alternatively, in embodiments where the sensor 826 includes a flexible printed circuit with two or more electrodes, the two or more electrodes of the sensor 826 may cooperate to form one or more bipolar electrograms. Additionally or alternatively, the sensor 826 may be associated with a central electrode (e.g., annular electrodes 434a and / or 434b on the unfolding member 235). Figure 4The two electrodes work together to provide near-unipolar electrograms, as described in more detail below. For example, electrical activity detected (e.g., passively detected) by the central electrode and sensor 826 (acting as a surface electrode) can form the basis of a corresponding electrogram associated with each unique pair of the central electrode and sensor 826. As a more specific example, in an implementation where six sensors 826 are present, the central electrode can form six electrode pairs with the sensors 826, which in turn form the basis of six corresponding electrograms. The electrogram formed from the electrical signals received from each corresponding electrode pair (e.g., the central electrode and a corresponding sensor 826) can be generated by any of a variety of different methods. Generally, the electrogram associated with a corresponding electrode pair can be based on the difference between the signals from the electrodes in that pair, and thus more specifically, on the difference between the electrical signal received from the central electrode and the electrical signal received from the corresponding sensor 826. For example, the electrogram can be filtered or otherwise further processed to reduce noise and / or emphasize cardiac electrical activity. It should be understood that sensor 826 and the center electrode can cooperate to provide a near-unipolar electrogram as a complement or alternative to any one or more of the various methods described herein for determining contact, shape, force, and impedance, wherein each method may include further or alternative cooperation between sensor 826 and the center electrode.

[0100] Multiple sensors 826 can be used to detect deformation of the expandable portion 250 (e.g., modular electrode 352). For example, according to any method described herein, an electrical signal can be driven between the annular electrodes 434a and / or 434b on the unfolded member 235 and each of the multiple sensors 826. Alternatively or alternatively, an electrical signal can be driven between one of the sensors 826 and another of the sensors 826, or between one of the sensors 826 and an additional sensor formed by and / or positioned on one of the electrical leads 806. Alternatively or alternatively, an electrical signal can be driven between two or more electrodes of one of the sensors 826. The electrical signal generated between (i) at least one of the sensors 826 and another of the sensors 826, (ii) between at least one of the sensors 826 and one or more annular electrodes 434a and / or 434b, (iii) between at least one of the sensors 826 and at least one additional sensor formed by and / or positioned on the electrical lead 806, and / or (iv) between two or more electrodes of at least one of the sensors 826 can be processed in the processing unit 110. Figure 1 Received at ) location.

[0101] The shape of the expandable portion 250 (e.g., the degree of expansion and / or deformation) can be detected, at least in part, based on measured electrical signals. For example, as the expandable portion 250 deforms, one or more sensors 826 may come into contact with the deployable member 235. It should be understood that, at least when the expandable portion 250 is in a fully deployed (uncompressed) state, a certain amount of force is required to deform the expandable portion 250 by a sufficient amount to bring one or more sensors 826 into contact with the deployable member 235. As used herein, this force can be considered a threshold, at least in terms of the meaning that forces below this threshold are insufficient to bring one or more sensors 826 close to the deployable member 235, and therefore will not be detected as contact between one or more sensors 826 and the deployable member 235.

[0102] In some embodiments, an axial electrode (e.g., a ring electrode on the shaft (not shown)) may be mounted to the distal portion 232 of the shaft 122, near the neck portion 357 (e.g., on or near the coupling member 367). The axial electrode can be used to measure electrographs according to a variety of methods described herein. Additionally or alternatively, electrical energy (e.g., current) can be driven by the axial electrode and one or more other electrodes (e.g., any one or more of the plurality of different electrodes described herein), and changes in the measured signal (e.g., voltage or impedance) can indicate the presence of a guide sheath covering the axial electrode. Continuing this example, the signal measured from the axial electrode can be combined with the signal measured from the sensor 826 to determine the position of the guide sheath relative to the end portion 124 and / or the distal portion 232 of the shaft 122.

[0103] refer to Figure 8D –10B, the end portion 124 may further include one or more position coil sensors (e.g., magnetic coil sensors). For example, coupling 365 and / or coupling 367 may include one or more slots or notches to receive and / or retain one or more position coil sensors 931, respectively. Figure 8D –9B) and one or more position coil sensors 1031 ( Figure 8D 10A and 10B). Alternatively or additionally, the end portion 124 may include a position coil sensor 1032 mounted on one or more supports 755 and / or 757. Figure 8D 10A and 10B).

[0104] In some embodiments, position coil sensors 931, 1031, and / or 1032 are magnetic coil sensors configured to emit a magnetic field, while other coils (e.g., external to patient 102, other coil sensors 931, 1031, and / or 1032, etc.) can be used to measure the generated magnetic field. Alternatively or additionally, coils external to patient 102 may be configured to emit a magnetic field. In these and other embodiments, position coil sensors 931, 1031, and / or 1032 may be configured to transmit and / or receive signals representing information relating to three to six degrees of freedom. For example, position coil sensors 931, 1031, and / or 1032 may transmit and / or receive signals representing position information of coil sensors 931, 1031, and / or 1032 in three-dimensional space (e.g., signals representing x, y, and / or z position coordinates relative to a defined origin (such as an external reference frame) and / or relative to one or more of position coil sensors 931, 1031, and / or 1032). Alternatively or additionally, position coil sensors 931, 1031, and / or 1032 can transmit and / or receive signals representing pitch, yaw, and / or roll information. Therefore, position coil sensors 931, 1031, and / or 1032 can be used to resolve the position of the distal portion 124 (e.g., within the patient 102) relative to a defined origin and / or can be used to calculate and determine the shape and / or orientation (e.g., posture) of the expandable portion 250. Alternatively or additionally, position coil sensors 931, 1031, and / or 1032 can be used to (i) determine the distance between coil sensor 931 and coil sensor 1031, and / or (ii) determine the distance and / or angle between coil sensors 931, 1031, and / or 1032. In turn, the determined distance and / or angle can be used to determine and / or estimate the shape of the expandable portion 250 (e.g., the degree of expansion and / or deformation).

[0105] refer to Figure 8DMultiple components of the distal portion 124 may be used individually or in combination to determine the position, shape (e.g., level of expansion and / or deformation), and / or orientation of the distal portion 124 (e.g., the expandable portion 250). For example, position and / or orientation information may be provided by position coil sensors 931, 1031, and / or 1032, as discussed above. Alternatively or additionally, fluorescence fluoroscopy visualization (e.g., X-ray, CT, etc.) may be used to determine the position, shape, and / or orientation of the distal portion 124. For example, in some embodiments, at least a portion of the distal portion 124 is radiopaque, and the expandable portion 250 is observable using fluorescence fluoroscopy or other similar visualization techniques. In some embodiments, the expandable portion 250 of the distal portion 124 may be radiopaque, such that fluorescence fluoroscopy can provide a representation of the deformation and / or partial deformation of the expandable portion 250, and thus a representation of whether the expandable portion 250 is in contact with tissue. Alternatively or alternatively, one or more of the shaft 122, unfolding member 235, coupling member 367, coupling member 365, and / or sensor 826 may be composed of and / or coated with a radiopaque material, and thus visible using fluorescent light or other visualization techniques.

[0106] As a specific example, a portion of the unfolding member 235, surrounded by the expandable portion 250 of the end portion 124, may include three concentric tubes. Each concentric tube may include a radiopaque loop, and all three loops may be distinct (e.g., separate) under fluorescence fluoroscopy when the unfolding member 235 is fully extended distally (e.g., when the expandable portion 250 is fully compressed). As the unfolding member 235 retracts (e.g., as the distal portion 240 of the end portion 124 moves proximally), the distal concentric tube of the unfolding member 235 slides within the proximal concentric tube of the unfolding member 235, such that the radiopaque loop on the distal concentric tube overlaps the proximal concentric tube during fluorescence fluoroscopy. Therefore, the extent of unfolding of the expandable portion 250 can be determined at least in part based on the relative positions of the radiopaque loops on the unfolding member 235. In other embodiments, the portion of the unfolding member 235 surrounded by the expandable portion 250 of the end portion 124 may include more (e.g., four or more) or fewer (e.g., two) concentric tubes, and / or may include a different (e.g., two or more) number of nontransparent wire loops for each concentric tube.

[0107] Alternatively or additionally, the coupling element 367 may include a radiopaque loop. In some embodiments, the radiopaque loop on the coupling element 367 may be significantly different from the radiopaque elements of other components of the catheter 104 (e.g., from the radiopaque loop on the unfolding member 235) (e.g., by size and / or pattern). Thus, the radiopaque loop on the coupling element 367 may provide orientation (e.g., posture) information of the distal portion 124 during fluoroscopic visualization.

[0108] In some embodiments, the shape of the expandable portion 250 (e.g., degree of unfolding, deformation, etc.) can be predicted based on the position of the unfolding member 235. A displacement measuring device (potentiometer, encoder, or other device known in the art) in the handle 120 can be used to measure the displacement of the unfolding member 235. The measured displacement can be processed by the processing unit 110 ( Figure 1 ) is used to determine the shape of the expandable portion 250 for display in the graphical user interface 109. Figure 1 )superior.

[0109] In these and other embodiments, electrical measurements captured by all or a subset of the sensors 826 can be used to determine the shape of the expandable portion 250. For example, when an electrical signal is driven by an electrode pair, measurements can be detected by the electrode pair (e.g., a pair of sensors 826, sensor 826 and ring electrode 434a). Figure 4 ), sensor 826 and ring electrode 434b ( Figure 4 The impedance detected by the processing unit 110 (e.g., as a result of the processing unit 110) Figure 1 (The received signal). The impedances detected for multiple electrode pairs can be compared with each other, and the relative distance between the components of each electrode pair can be determined. For example, if the sensors 826 are identical, each sensor 826 can be driven as part of a corresponding electrode pair including the annular electrode 434a and / or annular electrode 434b of the deployment member 235. For each such electrode pair, the measured impedance between the electrode pairs can represent the relative distance between the specific sensor 826 forming the corresponding electrode pair and the annular electrode 434a and / or 434b. In embodiments where the deployment member 235 is stationary when driving electrical signals through the electrode pairs, the relative distance between each sensor 826 and the deployment member 235 can further represent the relative distance between each sensor 826 and each other sensor 826. Generally, driven electrodes with lower measured impedances are closer to each other than those driven electrode pairs with higher measured impedances. In some cases, the electrodes associated with undriven modular electrodes 352 (e.g., one or more sensors 826) can be measured to determine additional information about the location of driven current pairs.

[0110] Measurements received solely by processing unit 110 and associated with the driven current pair, or combined with measurements at the undriven sensor 826, can be fitted to a model and / or compared with a lookup table to determine the displacement of the expandable portion 250 of the end portion 124. For example, the determined displacement of the expandable portion 250 may include displacement in at least one of the axial or lateral (radial) directions. It should be understood that due to the spatial separation of the current pairs in three dimensions, the determined displacement of the expandable portion 250 may be in more than one direction (e.g., axial, lateral, and combinations thereof). Additionally or alternatively, the determined displacement of the expandable portion 250 may correspond to the three-dimensional shape of the expandable portion 250 of the end portion 124. Therefore, the determined displacement of the expandable portion 250 can be used, for example, to determine the shape of the expandable portion 250. Further or alternatively, signals measured by an ultrasonic transducer, optical fiber, and / or other type of image sensor included in sensor 826 and / or disposed on the deployment member 235 can be used to determine the displacement of the expandable portion 250 (and thus the shape).

[0111] In embodiments where the axial force-displacement and / or lateral force-displacement response of the expandable portion 250 is reproducible for a given deployed state, the amount of force applied to the expandable portion 250 of the end portion 124 in the axial and / or lateral directions can be reliably determined based on the corresponding displacement of the expandable portion 250 in a given deployed state. Therefore, the determined displacement of the expandable portion 250 can be used to determine the amount and direction of the force applied to the expandable portion 250. Specifically, the processing unit 110 can determine the force applied to the expandable portion 250 based on the determined displacement of the expandable portion 250. For example, using a lookup table, curve fitting, or other predetermined relationship, the processing unit 110 can determine the direction and magnitude of the force applied to the expandable portion 250 based on the magnitude and direction of the displacement of the expandable portion 250, as determined by any one or more of the methods for determining displacement described herein. Therefore, it should be understood that the reproducible relationship between force and displacement along the expandable portion 250, combined with the ability to determine displacement using a sensor 826 positioned along the modular electrode 352, can help determine whether an appropriate amount of force has been applied during ablation treatment, and additionally or alternatively, can help determine the appropriate energy and / or cooling dose for lesion formation.

[0112] The detection and / or observation of the position, shape, and / or orientation of the distal portion 124 can, for example, provide increased certainty that the expandable portion 250 is engaging with the tissue and / or that the intended treatment is actually being delivered to the tissue. It should be understood that increased certainty in the positioning of the modular electrode 352 relative to the tissue can increase the likelihood that energy is applied to the correct location within the patient's tissue and / or can reduce the likelihood of causing stenosis in the pulmonary veins and / or creating gaps in injury patterns around the pulmonary vein orifices.

[0113] In some embodiments, the graphical user interface 109 ( Figure 1 The graphical user interface 109 can be used to display various information collected by the distal portion 124 of the catheter 104. For example, the graphical user interface 109 can be used to display the catheter 104 on a drawing system (e.g., within an anatomical model of the patient 102), where icons represent the position, orientation, and / or shape of the distal portion 124 and the axis 122. For example, based on the determined displacement of the expandable portion 250 of the distal portion 124, the processing unit 110 ( Figure 1 A representation of the shape of the expandable portion 250 can be sent to the graphical user interface 109. This representation of the shape of the expandable portion 250 may include, for example, a graphical representation of the shape of the expandable portion 250 corresponding to a determined deformation. In these and other embodiments, the graphical user interface 109 may be used to display the treatment location (e.g., the location of the injury). Additionally or alternatively, the graphical user interface 109 may be used to display other information corresponding to the distal portion 124 of the catheter 104. For example, the graphical user interface 109 may be used to display voltage and / or temperature measurements captured by one or more sensors 826. As a specific example, the graphical user interface 109 may be used to display a representation of at least one electrogram measured by one or more sensors 826, a central electrode, and / or by one or more additional sensors formed and / or positioned on one or more electrical leads 806, and / or other information corresponding to the distal portion 124 of the catheter 104 (e.g., a voltage graph associated with the electrogram). As another example, the graphical user interface 109 can be used to display an electroanatomical diagram based at least in part on the shape and / or location of the determined end portion 124.

[0114] Figure 11A –15 illustrates the end portion 124 configured according to several other embodiments of the present technology. Figure 11A The end portion 124 shown in –15 is similar to Figure 2 –10B shows the end portion 124. Therefore, similar reference numerals are used to indicate… Figure 2 Similar elements to those in –15, but the individual components may differ. Figure 11A –15 shows the end portion 124 and Figure 2 The difference in the end portion 124 shown in –10B is that the pillars 751, 755, and 757 of each mesh electrode plate 750 (and the pillars 755 and 757 respectively attached to the couplings 365 and 367) are designed to facilitate the formation of the expandable portions 1150 and 1550 in a general “onion” shape and / or a general “pumpkin” shape, rather than Figure 2 –10B shows the general “pear-shaped” shape of the expandable portion 250 of the end portion 124.

[0115] Figure 11A and 11B The onion-shaped expandable portion 1150 of the end portion 124 in the unfolded state is shown. Figure 12A and 12B These are, respectively, a top view and a perspective view of the farthest part 240 of the expandable section 1150. (Example) Figure 11A and 11B As shown, the expandable portion 1150 of the illustrated end portion 124 includes a neck portion 1157 and an active body portion 1152 (hereinafter referred to as "modular electrode 1152"). It is worth noting that the expandable portion 1150 does not include... Figure 2 –The protruding nose portion 355 of the expandable portion 250 shown in –10B is similar to that of the nose portion. Alternatively, refer together with Figure 11A –12B, the distal portion of the modular electrode 1152 (at least when the expandable portion 1150 is in its fully deployed state) can be formed substantially perpendicular to the deployable member 235 and positioned relatively flat against the distal surface of the tissue (e.g., around the pulmonary vein orifice). Therefore, the supports 755 of the mesh electrode plate of the expandable portion 1150 can contribute to the modular electrode 1152. Thus, in some embodiments, all or a portion of the supports 755 of the expandable portion 1150 can be used adjacent to (e.g., around the pulmonary vein orifice) and / or to deliver energy to the tissue. Alternatively or additionally, all or a portion of the supports 755 of the expandable portion 1150 can be insulated such that the insulated portion of the supports 755 can be adjacent to the tissue but not used to deliver energy to the tissue.

[0116] Figure 13 A side perspective view of the expandable portion 1150 of the end portion 124 is shown. As shown, the sensor 826 is distributed around the expandable portion 1150 and electrically coupled to the electrical lead 806, which is consistent with the above description. Figure 2 The discussion on –10B is consistent. Figure 13The one or more electrical leads 806 shown include one or more additional sensors 1326 formed by and / or positioned on the electrical leads 806 such that the one or more additional sensors 1326 are retained within the expandable portion 1150 and do not contact the tissue when the expandable portion 1150 contacts the tissue. As discussed in more detail above, the additional sensors 1326 can be used, for example, to form one or more electrograms and / or measure electrical signals (e.g., voltage or impedance) to determine the shape of the expandable portion 1150 (e.g., degree of expansion, deformation, etc.). The additional sensors may be coated with platinum black, iridium oxide, or gold (e.g., to reduce impedance or noise, and / or increase thermal conductivity).

[0117] To allow the expansion and compression of the expandable portion 1150, some embodiments may include a service loop 1306 for one or more electrical leads 806. The service loop 1306 may be held in a suitable position within the expandable portion 1150 in a variety of ways, including (i) winding or spirally winding the electrical leads 806 around the expansion member 235 or (ii) connecting two or more electrical leads 806 in a “Y” shape that at least partially mates with the expansion member 235.

[0118] Figure 14A –14C illustrates how the mesh electrode plate 750 can be attached to form an expandable portion 1150 of the end portion 124, which is consistent with the above. Figure 8A -8C discussion is consistent. For example, the eyelets 758 of adjacent mesh electrode plates 750 can be aligned (overlapped) and held together with fasteners 870. Polymer discs 872 formed of electrically insulating material can be used to separate and electrically isolate adjacent mesh electrode plates 750 from each other and / or from sensors 826 included in fasteners 870. Additionally or alternatively, grommets 873 ( Figure 14A The sensor 826 can be positioned in the opening of the aligned eyelet 758 between the sensor 826 and the board 750 (e.g., to electrically isolate the sensor 826 from the board 750).

[0119] A seal 874 may be formed over the back of the fastener 870 and / or the sensor 826 (e.g., to electrically insulate a portion of the non-contact tissue of the sensor 826, to electrically insulate the sensor 826 from the plate 750, and / or to electrically isolate the plates 750 from each other). In some embodiments, the seal 874 may be an in-situ cured adhesive. In other embodiments, the seal 874 may be a reflow thermoplastic or other insulator.

[0120] Figure 14AThe support 751 of the plate 750 shown in –14C includes one or more features or bends 1450 near the corresponding eyelets 758. When the plates 750 are attached to each other, the bends 1450 in the support 751 can help to recess the sensor 826 included in the fastener 870 relative to the exterior of the expandable portion 1150. As discussed above, this can be advantageous, for example, allowing the expandable portion 1150 to smoothly enter and exit the guide sheath (e.g., without one or more corresponding sensors 826 being stuck on the lip of the guide sheath at one or more openings in the sheath).

[0121] Figure 15 An expandable portion 1550 of the end portion 124 in its unfolded state is shown. The expandable portion 1550 is similar to... Figure 11A The expandable portion 1150 shown in –14C, except that the strut 755 of the plate 750 is attached to the distal portion of the coupling member 365. Thus, the strut 755 extends distally from the coupling member 365 to form an inverted nose portion 1555. The inverted nose portion 1555 includes the distal portion 1540 of the expandable portion 1550 and prevents the coupling member 365 (e.g., the distal portion 240 of the end portion 124) from contacting tissue when the expandable portion 1550 is in a fully (or substantially fully) deployed state. This can be advantageous, for example, by using the distal side or surface of the expandable portion 250 to deliver energy to tissue without interference from the coupling member 365. Therefore, in some embodiments, all or a portion of the strut 755 of the expandable portion 1550 may be used adjacent to and / or to deliver energy to tissue. Alternatively or additionally, all or a portion of the strut 755 of the expandable portion 1550 may be insulated, such that the insulated portion of the strut 755 may be adjacent to tissue but not used to deliver energy to tissue.

[0122] 1. Related methods

[0123] Figure 16 According to several embodiments of this technology, the treatment site is positioned within the patient's anatomical structure (in this case, near the orifice 1613 of the pulmonary vein 1611 in the left atrium of the patient's heart 1610). Figure 2 A schematic diagram of the end portion 124 of –10B. For clarity and explanation, the following is combined with… Figure 16 discuss Figure 17 and 18 However, those skilled in the art will readily recognize that Figure 17 and 18 All or part of the described methods can be applied using an end portion 124 configured according to several other embodiments of the present technology, such as an end portion 124 having an expandable portion with modular electrodes, similar to... Figure 11A–15 shows the expandable portions 1150 and / or 1550 with modular electrodes 1152. Additionally, those skilled in the art will readily recognize that… Figure 17 and 18 The methods described, in whole or in part, can be applied in settings other than pulmonary vein isolation procedures, such as in any of the various medical procedures performed on a patient’s hollow anatomical structures, and more specifically, in the process of diagnosing, stimulating, electrically isolating, or treating tissues within and / or near anatomical structures.

[0124] Figure 17 This is a flowchart illustrating a method 1740 according to several embodiments of the present technology for positioning the distal portion of a catheter at a treatment site within the patient's anatomy. All or a subset of the steps of method 1740 may be performed by multiple components or devices of a medical system, such as... Figure 1 The system 100 shown or other suitable systems. For example, all or a subset of the steps of method 1740 may be performed by (i) components or devices of interface unit 108, (ii) components or devices of medical device 104, and / or (iv) drawing system 112, recording system 113, fluid pump 114, and / or generator 115. Alternatively or additionally, all or a subset of the steps of method 1740 may be performed by a user of system 100 (e.g., an operator, physician, etc.). Furthermore, any one or more steps of method 1740 may be performed in accordance with the discussion above.

[0125] Let's refer to each other. Figure 16 and 17 Method 1740 begins at frame 1741, delivering the distal portion 124 of catheter 104 to a treatment site within the patient's anatomy. For example, the distal portion 124 may be inserted into the patient in a compressed state and delivered via a vein in the patient's leg or arm to the patient's heart 1610. In some embodiments, the distal portion 124 may be manipulated to a pulmonary vein 1611 in the patient's heart (e.g., to the orifice 1613 of the pulmonary vein 1611 in the left atrium of the patient's heart 1610) using a guide sheath (e.g., a manipulable guide sheath such as that of AbbottAgilis) and / or guidewire 397. In these and other embodiments, fluoroscopy and / or other visualization techniques may be used to manipulate the distal portion 124 to the treatment site. In these and other embodiments, positional information provided by position coil sensors 931, 1031, and / or 1032 and / or sensors 826 distributed around the deformable portion 250 of the distal portion 124 may be used to manipulate the distal portion 124 to the treatment site.

[0126] At frame 1742, the extendable portion 250 of the distal portion 124 unfolds at the treatment site. For example, the extendable portion of the distal portion 124 can be unfolded by retracting the unfolding member 235 of the distal portion 124 relative to the distal portion 232 of the axis. In some embodiments, unfolding may include using the handle 120 of the catheter 104 (… Figure 2 The actuating part 246 on the ) Figure 2 ) to retract the unfolding component 235.

[0127] To deploy the expandable portion 250 of the distal portion 124, the nasal portion 355 of the expandable portion 250 can be pushed into the pulmonary vein 1611 in a compressed state and then expanded to an deployed state corresponding to the size of the pulmonary vein 1611. As the expandable portion 250 expands, the nasal portion 355 can engage with the wall of the pulmonary vein 1611 so that the nasal portion 355 is centered within the pulmonary vein 1611. Alternatively, the pear shape of the expandable portion 250 allows the wall of the pulmonary vein 1611 to push at least a portion of the modular electrode 352 of the expandable portion 250 out of the opening of the pulmonary vein 1611 into the left atrium of the heart 1610, thereby preventing portions of the modular electrode 352 from engaging with tissue within the pulmonary vein 1611. In this way, the distal portion 124 of the catheter 104 can be extended to a size corresponding to the size of the pulmonary vein 1611, while ensuring that only the insulating portion of the extendable portion 250 extends beyond the orifice of the pulmonary vein 1611 and the active portion of the extendable portion 250 (i.e., the modular electrode 352) is appropriately positioned against the tissue in the left atrium of the heart 1610 surrounding the orifice 1613 of the pulmonary vein 1611 (rather than against the tissue within the pulmonary vein 1611). Therefore, the likelihood of the pulmonary vein 1611 becoming narrowed due to treatment is reduced.

[0128] In other embodiments, to deploy the expandable portion 250 of the distal portion 124, the expandable portion 250 may be extended to a deployed state before at least the nasal portion 355 of the expandable portion 250 is pushed into the pulmonary vein 1611. For example, the expandable portion 250 may be extended to a fully deployed state or approximately the size of the pulmonary vein 1611. The nasal portion 355 of the expandable portion 250 is then advanced toward and / or pushed into the pulmonary vein 1611. If the nasal portion 355 is successfully pushed into the pulmonary vein 1611, in some embodiments the expandable portion 250 may be further extended until the nasal portion 355 engages with the wall of the pulmonary vein 1611 and is located at the center within the pulmonary vein 1611. Alternatively, if the nasal portion 355 cannot be successfully pushed into the pulmonary vein 1611, the expandable portion 250 may be compressed via distal movement of the deploying member 235 relative to the distal portion 232 of the shaft 122 until the nasal portion 355 is successfully pushed into the pulmonary vein 1611.

[0129] In these and other embodiments, the extendable portion of the distal portion 124 can be extended to an deployed state until the distal portion of the nasal portion and / or the modular electrode forms a distal surface substantially perpendicular to the deployable member 235. The distal surface can then be positioned relative to the tissue surrounding the mouth 1613 of the pulmonary vein 1611 (e.g., at least a portion of the coupling member 365 and / or the strut 755 is positioned within the pulmonary vein 1611).

[0130] At frame 1743, method 1740 verifies that the distal portion 124 is correctly positioned at the treatment site. Specifically, method 1740 verifies that the modular electrode 352 (e.g., its distal surface) engages with tissue in the left atrium of the heart 1610 surrounding the opening 1613 of the pulmonary vein 1611. Alternatively, method 1740 verifies that the distal portion 124 (e.g., the nasal portion 355) is located centrally within the pulmonary vein 1611. In these and other embodiments, method 1740 verifies that the strut 755, rather than the coupling member 365, is correctly positioned against the tissue.

[0131] In some embodiments, to verify placement of the distal portion 124 in the pulmonary vein 1611, the guidewire 397 may be further advanced into the pulmonary vein 1611 and / or a contrast dye may be injected into the pulmonary vein 1611 (e.g., from the opening of the lumen 349 of the unfolding member 235) to verify correct placement. In these and other embodiments, the position, shape (e.g., deformation and / or level of expansion), and / or orientation of the distal portion 124 may be determined according to any one or more of the various methods described herein (e.g., fluorescence fluoroscopic visualization; position and / or orientation information provided by position coil sensors 931, 1031, and / or 1032; impedance measurements using sensor 826 and / or the annular electrodes 434a and / or 434b of the unfolding member 235; etc.) to verify placement of the distal portion 124 at the treatment site. In these and other embodiments, to verify proper placement of the distal portion 124 at the treatment site, the degree of contact between all or a portion of the modular electrode 352 and the tissue at the treatment site may be determined according to any one or more of the various methods described herein.

[0132] Although the steps of method 1740 are discussed and explained in a specific order, Figure 17The method 1740 shown is not limited thereto. In other embodiments, method 1740 may be performed in a different order. In these and other embodiments, any step of method 1740 may be performed before, during, and / or after any other step of method 1740. Furthermore, those skilled in the art will recognize that the method shown can be modified while still remaining within these and other embodiments of the present technology. For example, in some embodiments, steps may be omitted and / or repeated. Figure 17 One or more steps of the method 1740 shown.

[0133] Figure 18 This is a flowchart illustrating a method 1850 for diagnosing and / or treating tissue at a treatment site within the anatomical structure of a patient, according to several embodiments of the present technology. For example, Figure 18 This is to show the use of pulmonary vein 1611 for diagnosis and / or treatment ( Figure 16 ) of mouth 1613 ( Figure 16 ) around the patient's heart 1610 ( Figure 16 The flowchart of method 1850, which involves electrically isolating the pulmonary vein 1611 from the patient's heart 1610 by tissue within the left atrium, describes the process. All or a subset of the steps of method 1850 can be performed by multiple components or devices of a medical system, such as... Figure 1 The system 100 shown or other suitable systems. For example, all or a subset of the steps of method 1850 may be performed by (i) components or devices of interface unit 108, (ii) components or devices of medical device 104, and / or (iv) drawing system 112, recording system 113, fluid pump 114, and / or generator 115. Alternatively or additionally, all or a subset of the steps of method 1850 may be performed by a user of system 100 (e.g., an operator, physician, etc.). Furthermore, any one or more steps of method 1850 may be performed in accordance with the discussion above.

[0134] Let's refer to each other. Figure 16 and 18 Method 1850 begins at block 1851, determining the position, shape, contact, and / or orientation of the distal portion 124 of the catheter 104 at the treatment site. For example, the position, shape, contact, and / or orientation of the distal portion 124 can be determined according to any one or more of the various methods described herein and / or in a manner similar to that described above with respect to block 1243 of method 1240 (Figure 12). In some embodiments, the size and / or effective surface area of ​​the expandable portion 250 of the distal portion 124 corresponding to the current unfolding (expansion) level of the expandable portion 250 can be determined. In these and other embodiments, which portions of the modular electrode 352 (e.g., which mesh electrode plates 750 (…)) can be determined… Figure 7A and 7B(Which parts of a single plate, etc.) are currently in contact with the tissue at the orifice 1613 of the pulmonary vein 1611. In these and other embodiments, the effective surface area of ​​the modular electrode 352 (e.g., the entire modular electrode 352, each individual plate, etc.) in contact with the tissue surrounding the treatment site can be determined.

[0135] At box 1852, method 1850 can diagnose and / or treat tissue at the treatment site. In some embodiments, tissue is diagnosed by measuring the characteristics of the tissue according to any one or more of the various methods described herein. For example, one or more of the sensors 826 distributed around the modular electrode 352, the modular electrode 352 itself, the annular electrodes 434a and / or 434b of the unfolded member 235, and / or one or more additional sensors 1326 formed by and / or positioned on one or more electrical leads 806 (…). Figure 13 The method measures electrical signals in the tissue. Based at least in part on the measured electrical signals, one or more electrographs and / or electroanatomical maps corresponding to the tissue can be generated, which is in contact with and / or near one or more of the sensors 826, modular electrodes 352, ring electrodes 434a and / or 434b, and / or formed by one or more electrical leads 806 and / or located on one or more electrical leads and additional sensors 1326 on them. In this way, method 1850 (i) can identify tissue exhibiting abnormal electrical behavior that may lead to a condition of patient 102 (e.g., atrial fibrillation) and / or (ii) can track the electrical behavior of the tissue as it is treated. In these and other embodiments, the tissue can be diagnosed by measuring electrical activation (e.g., using one or more sensors 826) and / or by pacing the heart 1610 of patient 102. In these and other embodiments, the tissue can be diagnosed by determining the thickness of the tissue (e.g., based on the anatomical location of the tissue and / or other measurements captured by catheter 104).

[0136] In some embodiments, energy (e.g., electrical energy) can be delivered to selected plates of the modular electrode 352 to treat tissue at a treatment site. Conversely, selected plates of the modular electrode 352 can deliver energy to tissue. For example, a generator 115 ( Figure 1This method delivers radio frequency (RF) energy to one or more plates of a modular electrode 352. As a more specific example, method 1850 may deliver approximately 1 amp to 4 amps (e.g., between approximately 2 amps and 3 amps, or approximately 2.6 amps) together and / or separately to each plate for approximately 4 seconds (e.g., between 2 and 9 seconds total, between 3 and 5 seconds per plate, etc.) at approximately 500 kHz (e.g., between 400 kHz and 600 kHz). In some embodiments, the parameters of the RF energy delivered to the tissue via the modular electrode 352 may be adjusted (e.g., changed) based on a variety of factors, as discussed in more detail below.

[0137] As another example, generator 115 can be used to deliver pulsed field ablation (e.g., irreversible electroporation) and / or another form of energy to one or more plates of modular electrodes to treat tissue at the treatment site. As a more specific example, method 1850 can deliver biphasic pulses of about 18 amps to each plate together and / or separately, repeating approximately every 1 ms (e.g., 0.5 ms to 10 ms), for a total of about 3 seconds (e.g., 1.5 seconds to 10 seconds). These pulses are repeated once every 1 ms (e.g., 0.5 ms to 10 ms).

[0138] Alternatively, method 1850 may use generator 115 to deliver energy pulse trains of various forms to one or more plates of the modular electrode. For example, method 1850 may deliver a series of closely spaced (e.g., temporally) energy pulses, followed by a pause period in which no energy is delivered. At the end of the pause period, method 1850 may deliver another series of closely spaced energy pulses, followed by another pause period. Method 1850 may repeat this cycle as needed. In other embodiments, method 1850 may vary the amount of current delivered during different pulses (e.g., pulse trains). In some embodiments, parameters of the pulse field and / or other energy delivered to the tissue via modular electrode 352 may be adjusted (e.g., varied) based on a variety of factors discussed in more detail below.

[0139] In these and other embodiments, in order to treat the tissue at the treatment site, generator 115 ( Figure 1 Channels, relays, and / or transistors can be used to drive the mesh electrode plates of the expandable portion 250 separately and / or simultaneously. In some embodiments, all or a subset of the plates of the modular electrode 352 can be configured as monopolar electrodes (e.g., in the case of the plate with the patient 102). Figure 1 One or more external return electrodes 118 Figure 1The method 1850 can drive the current returning through each electrode 118. In embodiments with multiple return electrodes 118, the method 1850 can balance the current returning through each electrode 118. For example, more information on current balancing between return electrodes can be found, for example, in U.S. Patent Application Serial No. 16 / 493,288 assigned to Afra Corporation, which is incorporated herein by reference in its entirety. Alternatively, the drive plates can be configured with bipolar electrodes. For example, the method 1850 can deliver energy between adjacent and / or separate (e.g., opposite) plates, and / or the method 1850 can deliver energy between one or more mesh electrode plates and a central electrode (e.g., an annular electrode on the unfolded member and / or another electrode on the end portion 124).

[0140] In some embodiments, method 1850 includes driving each of the mesh electrode plates together. In these and other embodiments, method 1850 includes driving the individual plates separately from each other. For example, assuming the expandable portion 250 includes six plates, method 1850 may drive the plates in the following order: (i) the first plate; (ii) the second plate; (iii) the third plate; (iv) the fourth plate; (v) the fifth plate; and (vi) the sixth plate. In some embodiments, time is used to drive the plates of the expandable portion 250 separately.

[0141] In these and other embodiments, method 1850 may include driving boards in multiple subgroups simultaneously. For example, assuming the expandable portion 250 includes six boards, method 1850 may drive the boards in the following order: (i) a first board together with a second board adjacent to the first board; (ii) a second board together with a third board adjacent to the second board; (iii) a third board together with a fourth board adjacent to the third board; (iv) a fourth board together with a fifth board adjacent to the fourth board; (v) a fifth board together with a sixth board adjacent to the fifth board; and (vi) a sixth board together with a first board adjacent to the sixth board. In these and other embodiments, method 1850 may drive other groups of boards (e.g., a group of two boards opposite each other on the expandable portion 250, a group of two boards separated by adjacent boards, a group of three or more boards, a group of every other board, etc.). Other groups of boards are, of course, possible and within the scope of this art. In some embodiments, time division is used to drive groups of boards separately.

[0142] When the plates of the expandable portion 250 are driven separately to treat tissue, method 1850 may perform only one instance of energy delivery to each plate. In other embodiments, method 1850 may perform multiple (e.g., fewer) instances of energy delivery to each plate. For example, after method 1850 has sequentially powered the individual plates for the first time, method 1850 may sequentially power the individual plates a second time. In some embodiments, multiple instances of energy delivery to each plate may allow cooling of the plate after method 1850 drives the plate and before method 1850 subsequently drives the plate again.

[0143] Compared to conventional pulmonary vein isolation catheters, selectively driven plates of modular electrodes offer several advantages. For example, instead of delivering a large amount of energy (e.g., 900 J) to patient 102 at once, method 1850 delivers a smaller amount of energy (e.g., 150 J per plate in the case of six plates in the expandable portion 250) while maintaining the same or similar current density on the expandable portion 250 (because the effective surface area of ​​the subset of plates is smaller than the effective surface area of ​​the entire expandable portion 250) and delivering the same total amount of energy to patient 102 over time. Additionally, or alternatively, the degree of tissue contact, the degree of plate unfolding / deformation, and other characteristics of the tissue at the treatment site and / or of the individual plates can vary on the expandable portion 250. Therefore, selectively driving the plates of modular electrode 352 according to tissue characteristics and other factors local to the plate provides greater granularity and control over the energy delivered to the tissue at the treatment site through each portion of modular electrode 352, as described in more detail below.

[0144] In some embodiments, energy delivery may be synchronized with the refractory period of ventricular activation. For example, relative to when method 1850 detects ventricular activation and / or paces the ventricle via electrodes (e.g., modular electrode 352, one or more of sensor 826, etc.), method 1850 may trigger energy delivery to modular electrode 352 with a predetermined time delay.

[0145] In these and other embodiments, method 1850 can adjust the energy delivered to the modular electrode 352 based on a variety of factors. In some embodiments, the location, shape, contact, and / or orientation information of the end portion 124 determined at frame 1851 and / or tissue characteristics determined during tissue diagnosis at frame 1852 can be used to adjust the energy delivered to the tissue via the modular electrode 352. For example, energy delivery can be adjusted based on the anatomical location of the tissue. As a specific example, method 1850 can determine that a first plate is contacting a thinner (e.g., posterior) portion of the tissue at the treatment site, and a second plate is contacting a thicker (e.g., anterior) portion of the tissue at the treatment site. Therefore, in some embodiments, method 1850 can deliver less energy via the first plate contacting the thinner portion of the tissue than via the second plate to the thicker portion of the tissue.

[0146] In these and other embodiments, since the current density at a given point along the modular electrode 352 is a function of the effective surface area at that given point along the modular electrode 352, the energy delivered to the plates of the modular electrode can be adjusted based on the shape of the expandable portion 250 (e.g., the level of expansion and / or deformation) to maintain a target current density of energy delivered to the tissue by each plate of the modular electrode 352 in contact with the tissue. For example, a pulmonary vein with a smaller diameter generally requires less energy to treat the tissue around the mouth of a smaller pulmonary vein compared to a pulmonary vein with a larger diameter. Continuing this example, the expandable portion 250 when correctly positioned in a smaller pulmonary vein is less expanded (and therefore has a smaller effective surface area) than the expandable portion 250 when correctly positioned in a larger pulmonary vein. Therefore, method 1850 can deliver less energy to the plates of the modular electrode 352 when the modular electrode 352 is positioned within a smaller pulmonary vein, and more energy to the plates of the modular electrode 352 when the modular electrode 352 is positioned within a larger pulmonary vein. As an additional example, the first plate of the modular electrode 352 may be deformable (e.g., via contact with tissue) and / or have less contact with tissue compared to the second plate of the modular electrode 352. In either or both of these cases, method 1850 may determine that the first plate has a smaller effective surface area than the second plate, and therefore less energy can be delivered to the first plate than to the second plate to maintain the target current density of energy delivered to the tissue through each plate of the expandable portion 250.

[0147] At frame 1853, multiple parameters of the medical device and / or tissue are monitored during diagnosis, treatment, or both of the tissue. For example, during RF energy delivery, one or more sensors 826 may measure the temperature of the tissue and / or portions of the modular electrode 352. In these embodiments, the amount and / or temperature of the flushing fluid delivered to the treatment site may be varied at least in part based on temperature measurements. For example, method 1850 may increase the flow rate of the flushing fluid delivered to the modular electrode 352 and / or the treatment site and / or decrease its temperature as the temperature of the tissue and / or portions of the modular electrode 352 increases. Additionally, or alternatively, the energy delivered to the plate of the modular electrode 352 may be adjusted at least in part based on temperature measurements captured by one or more sensors 826 corresponding to and / or proximate to the plate. For example, method 1850 may reduce or terminate the energy delivery to the plate when the temperature measurement corresponding to the plate reaches or exceeds a threshold temperature. In some embodiments, method 1850 may wait until the temperature measurement corresponding to the plate drops below a threshold temperature before resuming energy delivery to the plate. In this way, method 1850 can reduce the likelihood of coagulation or carbonization of the treated tissue. In some embodiments, when the temperature measurement corresponding to another plate is at or below a threshold temperature or another temperature, method 1850 can continue to deliver energy to the tissue around the mouth via the other plates of modular electrode 352. Alternatively, in addition to reducing or terminating the delivery of energy to the plate whose corresponding temperature measurement reaches or exceeds the threshold temperature, method 1850 can reduce or terminate the delivery of energy to other plates of modular electrode 352 (e.g., delivery to all other plates; delivery to a subset of other plates, such as adjacent plates; etc.).

[0148] In these and other embodiments, temperature measurements captured by one or more sensors 826 can be used for other purposes. For example, during RF or pulsed field energy delivery, a temperature rise captured by sensor 826 can indicate contact between one or more corresponding plates and tissue at the treatment site. Therefore, temperature measurements captured by one or more sensors 826 can be used to determine which portions of the modular electrode 352 are in contact with tissue, and also, or alternatively, to determine which portions of the modular electrode 352 are undesirably in contact with tissue (e.g., in cases where the distal portion 124 is undesirably moved relative to the treatment site). In this way, method 1850 can reduce the likelihood of treating tissue other than the target tissue at the treatment site. In other words, method 1850 can increase the likelihood of precisely treating the target tissue at the treatment site. In these and other embodiments, temperature measurements can be used to determine damage characteristics and adjust energy delivery accordingly.

[0149] In some embodiments, electrical activity of target tissue at the treatment site can be monitored. For example, the impedance between multiple pairs of sensors 826 can be monitored, (ii) the impedance between one of the sensors 826 and the ring electrodes 434a and / or 434b, (iii) the impedance between multiple electrodes of one or more sensors 826, and / or (iv) multiple sensors and one or more additional sensors 1326 formed by one or more electrical leads 806 and / or positioned on one or more electrical leads 806. Figure 13 The impedance between the expandable portion 250 and the tissue is measured. Impedance measurements can be used to determine the shape of the expandable portion 250 (e.g., to determine if the expandable portion 250 is undesirably deformed) and / or as feedback on damage characteristics (impedance changes when tissue is treated). As another example, electrograms provided by one or more sensors 826 corresponding to the tissue at the treatment site can be monitored. This feedback can be used to determine whether the treatment was successful (e.g., whether the pulmonary vein 1611 was successfully electrically isolated from the left atrium of the patient's heart 1610). In some embodiments, method 1850 may use one or more of a plurality of parameters to inform and / or regulate the energy delivered at block 1852.

[0150] At box 1854, method 1850 may selectively display a variety of visual markers. In some embodiments, method 1850 may display a model of an anatomical structure. In these and other embodiments, method 1850 may display icons representing the location, shape, and / or orientation of the distal portion 124 and / or axis 122 (e.g., along or within the model of the anatomical structure). In these and other embodiments, method 1850 may selectively display a variety of other information, including electrograms and / or temperature measurements captured by one or more sensors 826, annotations representing the energy delivery area (e.g., on the model of the anatomical structure, on the icons of the distal portion to indicate which plate of the modular electrode 352 is currently driven, on one or more icons representing one or more previous locations where energy was delivered with the modular electrode 352, etc.), and / or current parameters of the energy delivered to the patient 102 (e.g., amperes, voltage, pulse parameters, frequency, activation time, etc.). In these and other embodiments, method 1850 may include information relating to the position of the modular electrode 352 (e.g., relative distance, relative axial translation, relative rolling, etc.) compared to previous (e.g., all previous, most recent, latest previous) energy deliveries. This can assist physicians in making subsequent energy deliveries to ensure continuous ablation of lesions within the desired treatment area.

[0151] At frame 1855, the distal portion 124 can be repositioned within and / or removed from the anatomy of the patient 102. For example, the distal portion 124 can be repositioned relative to the target pulmonary vein 1611 (e.g., closer to the opening or sinus, or rotated relative to the pulmonary vein 1611). As another example, the distal portion 124 can be repositioned at another pulmonary vein (e.g., after successful electrical isolation of the first pulmonary vein 1611). As yet another example, the distal portion 124 can be removed from the anatomy after tissue diagnosis and / or treatment at the treatment site. In some embodiments, the expandable portion 250 of the distal portion 124 can be compressed before repositioning and / or removing the distal portion 124. In these embodiments, the expandable portion 250 can be compressed via distal movement of the distal portion 232 of the unfolding member relative to the axis. When the position of the end portion 124 is reset after the expandable portion 250 is compressed, the expandable portion 250 can be re-expanded by moving the unfolding member 235 proximally relative to the distal portion 232 of the shaft 122.

[0152] Although the steps of method 1850 are discussed and explained in a specific order, Figure 18 The method 1850 shown is not limited thereto. In other embodiments, method 1850 may be performed in a different order. In these and other embodiments, any step of method 1850 may be performed before, during, and / or after any other step of method 1850. Furthermore, those skilled in the art will recognize that the method shown can be modified while still remaining within these and other embodiments of the present technology. For example, in some embodiments, steps may be omitted and / or repeated. Figure 18 One or more steps of the method 1850 shown.

[0153] A. Additional examples

[0154] Several aspects of this technology are illustrated in the following examples.

[0155] 1. A catheter, comprising: A shaft having a proximal portion and a distal portion; and The end portion is mechanically coupled to the distal portion of the shaft, wherein the end portion includes a plurality of mesh electrode plates that together define an expandable portion.

[0156] 2. The conduit according to Example 1, wherein each of the mesh electrode plates includes (i) a first insulating portion and a second insulating portion distributed along the axial direction of the mesh electrode plate and (ii) an active portion between the first insulating portion and the second insulating portion.

[0157] 3. The conduit according to Example 1, wherein each of the mesh electrode plates includes (i) a first insulating portion and (ii) an active portion distal to the first insulating portion.

[0158] 4. The catheter according to any one of Examples 1–3, wherein each of the mesh electrode plates includes a plurality of pillars, and wherein a first subset of the plurality of pillars defines a plurality of units.

[0159] 5. The catheter according to Example 4, wherein the plurality of units at least partially define an open area through which fluid, blood, or a combination thereof may flow.

[0160] 6. The catheter according to any one of Examples 1–5, wherein the distal portion further includes a deployment member mechanically coupled to the expandable portion at the most distal portion of the distal portion, and wherein the expandable portion encloses at least a portion of the deployment member between the distal portion of the shaft and the most distal portion of the distal portion.

[0161] 7. The conduit according to Example 6, wherein the deploying member is telescopic.

[0162] 8. The conduit according to Example 6 or Example 7, wherein the expandable portion is configured to expand and compress, respectively, via the unfolding member, along the proximal and distal sides of the axis defined by the axis.

[0163] 9. The catheter according to any one of Examples 6–8, wherein the deploying member defines a lumen configured to receive a guidewire.

[0164] 10. The catheter according to any one of Examples 6–9, wherein the unfolding member defines a lumen, and wherein the lumen is configured to deliver fluid at least between the proximal portion of the shaft and the distal portion of the distal portion.

[0165] 11. The conduit according to any one of Examples 6–10, wherein the expansion member defines a cavity and includes a plurality of orifices configured to radially disperse fluid from within the expandable portion toward the inner surface of the expandable portion.

[0166] 12. The catheter according to any one of Examples 6–11, wherein the unfolding member includes at least one annular electrode positioned on the portion of the unfolding member between the distal portion of the shaft and the distal portion of the end portion.

[0167] 13. The catheter according to any one of Examples 1–12, wherein: The expandable portion is pear-shaped or onion-shaped and includes an insulating neck portion and an active body portion distal to the insulating neck portion; The active main body includes modular electrodes; and The insulating neck portion is mechanically coupled to the distal portion of the shaft.

[0168] 14. The catheter according to Example 13, wherein: The expandable portion also includes a nose portion distal to the active body portion and the insulated neck portion; and The nasal portion is mechanically coupled to the farthest portion of the distal portion.

[0169] 15. The conduit according to any one of Examples 1–14, wherein each of the mesh electrode plates includes at least one eyelet, and wherein at least one fastener holds adjacent mesh electrode plates of the expandable portion together via the respective eyelets.

[0170] 16. The conduit according to Example 15, wherein the at least one fastener includes at least one sensor, and / or wherein the at least one sensor includes at least one electrode and / or a temperature measuring device.

[0171] 17. The conduit according to Example 16, wherein the at least one eyelet of each of the mesh electrode plates is directly connected to at least one support, and wherein the at least one support includes a bend such that the at least one sensor is recessed relative to the exterior of the expandable portion when the adjacent mesh electrode plates are held together by the at least one fastener.

[0172] 18. The conduit according to Example 16 or Example 17, wherein an electrical lead extends from the at least one sensor and enters the shaft within the interior of the expandable portion, and wherein the sensor is formed and / or positioned thereon by the electrical lead within the interior of the expandable portion.

[0173] 19. The conduit according to any one of Examples 1–18 further includes a displacement measuring device configured to measure the displacement of a deployable member mechanically coupled to the expandable portion to determine the shape of the expandable portion.

[0174] 20. The catheter according to any one of Examples 1–19 further includes an axial electrode mounted to the distal portion of the shaft.

[0175] 21. The catheter according to any one of Examples 1–20, wherein the mesh electrode plates of the expandable portion are electrically isolated from each other, such that electrical energy can be delivered from any one of the mesh electrode plates independently of the other one of the mesh electrode plates.

[0176] 22. The catheter according to any one of Examples 1–21, wherein: Each mesh electrode plate includes a bonded portion at the proximal and / or distal ends of the mesh electrode plate; The keying portion is configured to engage with a first coupling member at the distal end portion of the shaft and / or a second coupling member at the farthest portion of the end portion; and The bonding portion and the first and / or second coupling member are configured to mechanically couple the mesh electrode plate to the distal portion and / or the farthest portion of the end portion of the shaft.

[0177] 23. The catheter according to any one of Examples 1–22, wherein at least one mesh electrode plate comprises: The first support column is mechanically coupled to the deployment member at the farthest part of the said end portion; A second pillar, which couples to the first pillar at its most distal portion; and A third pillar is coupled to the first pillar at the farthest portion of the third pillar.

[0178] 24. The catheter according to any one of Examples 1–23, wherein: Each of the mesh electrode plates includes at least one strut mechanically coupled to the deployment member at the most distal portion of the end portion; and The at least one pillar of each of the mesh electrode plates extends distally from the farthest portion of the end portion.

[0179] 25. The catheter according to any one of Examples 1–24, wherein at least one of the mesh electrode plates comprises: The first support, which is mechanically coupled to the distal portion of the shaft; A second pillar, which is coupled to the first pillar at its nearest side portion; and A third pillar is coupled to the first pillar at its nearest side portion.

[0180] 26. The catheter according to any one of Examples 1–25, wherein at least one mesh electrode plate includes a proximal portion, a distal portion, and an intermediate portion between the proximal portion and the distal portion, and wherein the intermediate portion is wider than the proximal portion and the distal portion.

[0181] 27. The catheter according to any one of Examples 1–26, wherein: Each of the mesh electrode plates includes multiple pillars; A first subset of the plurality of pillars defines a plurality of units of the expandable portion; The expandable portion includes a distal portion, a proximal portion, and an equator between the distal portion and the proximal portion; and The expandable portion includes more units around the equator than around the distal portion and / or around the proximal portion of the plurality of units.

[0182] 28. The catheter according to any one of Examples 1–27, wherein: Each of the mesh electrode plates includes multiple pillars; A first subset of the plurality of pillars defines a plurality of units of the expandable portion; and At least one of the plurality of units is formed by (i) a first pillar belonging to the first subset of the first of the mesh electrode plates and (ii) a second pillar belonging to the second of the first subset of the mesh electrode plates, which is different from the first.

[0183] 29. The catheter according to any one of Examples 1–28, wherein: Each of the mesh electrode plates includes multiple pillars; A first subset of the plurality of pillars defines a plurality of units of the expandable portion; and The farthest unit among the plurality of units is formed by (i) a first pillar belonging to the first subset of the first of the mesh electrode plates and (ii) a second pillar belonging to the second of the first subset of the mesh electrode plates, which is different from the first.

[0184] 30. The catheter according to any one of Examples 1–29, wherein: Each of the mesh electrode plates includes multiple pillars; A first subset of the plurality of pillars defines a plurality of units of the expandable portion; and The nearest-side unit among the plurality of units is formed by (i) a first pillar belonging to the first subset of the first of the mesh electrode plates and (ii) a second pillar belonging to the second of the first subset of the mesh electrode plates, which is different from the first.

[0185] 31. The catheter according to any one of Examples 1–30, wherein: Each of the electrode plates includes multiple support pillars; The plurality of pillars includes (i) a first subset of pillars having one or more first lengths and / or one or more first widths and (ii) a second subset of pillars having one or more second lengths less than the one or more first lengths and / or one or more second widths less than the one or more first widths; and The first subset of the pillars includes the farthest pillar among the plurality of pillars and / or the nearest pillar among the plurality of pillars.

[0186] 32. The catheter according to any one of Examples 1–31, wherein: Each of the mesh electrode plates includes multiple pillars; The plurality of pillars define a plurality of units of the expandable portion; and At least one of the plurality of units is formed by at least four pillars.

[0187] 33. The catheter according to any one of Examples 1–32, wherein: At least one mesh electrode plate includes multiple pillars; and The nearest side pillar of the plurality of pillars includes a first portion having a first width and a second portion having a second width less than the first width.

[0188] 34. The catheter according to any one of Examples 1–33, wherein the distal portion further includes at least one position coil sensor configured to measure position and / or posture information of the distal portion.

[0189] 35. The conduit according to any one of Examples 1–34, wherein, without external force, the expandable portion is in an unfolded state, and its diameter is greater than the maximum diameter of the shaft.

[0190] 36. A method for treating a target tissue at a treatment site in a patient using the distal portion of a catheter, the method comprising: Determine the effective surface area of ​​the distal portion of the catheter, wherein the distal portion includes a plurality of mesh electrode plates, and wherein the plurality of mesh electrode plates are electrically insulated from each other and together define the expandable portion of the distal portion; and Deliver energy to the target tissue at the treatment site. Energy is delivered via at least one mesh electrode plate of the expandable portion, based at least in part on the determined effective surface area.

[0191] 37. The method according to Example 36, wherein determining the effective surface area includes determining the location and / or orientation of the end portion.

[0192] 38. The method according to Example 37, wherein determining the position and / or orientation of the end portion comprises: Fluorescent perforation visualization of the terminal portion; and / or At least one signal is received from the position coil sensor at the end portion, wherein the at least one signal is a representation of the position of the position coil sensor in three-dimensional space and / or a representation of the pitch, yaw, and / or roll of the position coil sensor.

[0193] 39. The method according to any one of Examples 36–37, wherein delivering the energy to the at least one mesh electrode plate of the expandable portion comprises delivering the energy to the at least one mesh electrode plate at least partially based on the location of the at least one mesh electrode plate within the anatomical structure of the patient.

[0194] 40. The method according to any one of Examples 36–39, wherein determining the effective surface area includes determining the degree of unfolding and / or deformation of the expandable portion.

[0195] 41. The method according to Example 40, wherein determining the degree of unfolding and / or deformation of the expandable portion includes: Fluorescent perforation visualization of the terminal portion; and / or One or more signals are received from two or more electrodes mounted on the expandable portion, wherein the one or more signals represent the impedance between the two or more electrodes.

[0196] 42. The method according to any one of Examples 36–41, wherein determining the effective surface area includes determining the degree of contact between the at least one mesh electrode plate and the tissue.

[0197] 43. The method according to any one of Examples 36–42, wherein delivering energy to the at least one mesh electrode plate of the expandable portion comprises delivering a specified amount of energy to the at least one mesh electrode plate to achieve a target current density of energy delivered through the at least one mesh electrode plate to tissue in contact with the at least one mesh electrode plate.

[0198] 44. The method according to any one of Examples 36–43, wherein delivering the energy to the at least one mesh electrode plate includes delivering the energy to all the mesh electrode plates of the scalable portion.

[0199] 45. The method according to Example 44, wherein delivering energy to all the mesh electrode plates of the scalable portion comprises delivering energy to the respective mesh electrode plates of the scalable portion separately and sequentially.

[0200] 46. ​​The method according to Example 44, wherein delivering the energy to all the mesh electrode plates of the scalable portion comprises subgroups of the mesh electrode plates of the scalable portion that deliver energy separately and sequentially.

[0201] 47. The method according to any one of Examples 36–43, wherein the at least one mesh electrode plate includes a subset of the mesh electrode plates of the expandable portion, wherein the subset includes fewer than all the mesh electrode plates of the expandable portion, and further wherein delivering the energy to the at least one mesh electrode plate includes delivering energy only to the mesh electrode plates of the subset.

[0202] 48. The method according to any one of Examples 36–47, wherein delivering the energy to the at least one mesh electrode plate comprises delivering radio frequency (RF) energy and / or pulsed field energy to the at least one mesh electrode plate.

[0203] 49. The method according to any one of Examples 36–48, further comprising: Receive one or more signals from one or more temperature measuring devices mounted on the expandable portion, wherein the one or more signals represent the temperature of tissue in contact with the at least one mesh electrode plate; The energy delivered to the at least one mesh electrode plate is adjusted based at least in part on one or more received temperature signals; and / or The flushing fluid is delivered to the tissue in contact with the at least one mesh electrode plate.

[0204] 50. An electrode plate for forming an expandable portion of the distal portion of a catheter, the electrode plate comprising: The first portion at the proximal end of the electrode plate; The second portion at the distal end of the electrode plate; and The active portion between the first portion and the second portion.

[0205] 51. The electrode plate according to claim 50, wherein the first portion is insulated.

[0206] 52. The electrode plate according to Example 50 or Example 51, wherein at least a portion of the second part is insulated.

[0207] 53. The electrode plate according to any one of Examples 50–52, wherein: The active component includes multiple pillars; and The multiple pillars define multiple units.

[0208] 54. The electrode plate according to Example 53, wherein the plurality of units at least partially define an open area of ​​the electrode plate through which fluid, blood, or a combination thereof may flow.

[0209] 55. The electrode plate according to Example 53 or Example 54, wherein at least one of the plurality of units is defined by at least four of the plurality of pillars.

[0210] 56. The electrode plate according to any one of Examples 50–55, wherein: The active component includes multiple pillars; The first part includes at least one pillar; The first portion has at least one support column having a first length and / or a first width; and One of the plurality of pillars has a second length less than the first length and / or a second width less than the first width.

[0211] 57. The electrode plate according to any one of Examples 50–56, wherein: The active component includes multiple pillars; The second part includes at least one pillar; The at least one pillar of the second part has a first length and / or a first width; and One of the plurality of pillars has a second length less than the first length and / or a second width less than the first width.

[0212] 58. The electrode plate according to any one of Examples 50–57, wherein: The first part includes at least one pillar; and The at least one pillar includes a first portion having a first width and a second portion having a second width less than the first width.

[0213] 59. The electrode plate according to any one of Examples 50–58, wherein the active portion is wider than the first portion.

[0214] 60. The electrode plate according to any one of Examples 50–59, wherein the active portion is wider than the second portion.

[0215] 61. The electrode plate according to any one of Examples 50–60, wherein the first portion comprises a single pillar.

[0216] 62. The electrode plate according to any one of Examples 50–61, wherein: The first part includes a single pillar; The active portion includes a first pillar that is directly coupled to the single pillar at the nearest side portion of the first pillar; and The active portion also includes a second pillar that is directly coupled to the single pillar at the nearest side portion of the second pillar.

[0217] 63. The electrode plate according to any one of Examples 50–62, wherein: The first part includes a single pillar; The active portion includes a first pillar directly coupled to the single pillar at the distal end of the single pillar; and The active portion includes a second pillar that is directly coupled to the single pillar at the distal end of the single pillar.

[0218] 64. The electrode plate according to any one of Examples 50–63, wherein the second portion comprises a single pillar.

[0219] 65. The electrode plate according to any one of Examples 50–64, wherein: The second part includes a single pillar; The active portion includes a first pillar that is directly coupled to the single pillar at the farthest portion of the first pillar; and The active portion also includes a second pillar that is directly coupled to the single pillar at the farthest portion of the second pillar.

[0220] 66. The electrode plate according to any one of Examples 50–65, wherein: The second part includes a single pillar; The active portion includes a first strut directly coupled to the single strut at its proximal end; and The active portion includes a second strut that is directly coupled to the single strut at the proximal end of the single strut.

[0221] 67. The electrode plate according to any one of Examples 50–66, wherein the second portion includes at least one support, and wherein the support of the at least one support is configured to be mechanically coupled to the most distal portion of the distal portion of the catheter.

[0222] 68. The electrode plate according to Example 67, wherein the pillar of the at least one pillar is configured to extend distally from the distal portion of the end portion when mechanically coupled to the distal portion of the end portion.

[0223] 69. The electrode plate according to any one of Examples 50–68, wherein: The electrode plate includes a bonded portion at the distal end of the electrode plate; The bonding portion is configured to engage with the coupling element at the most distal portion of the distal portion of the catheter; and The bonding portion and the coupling element are configured to mechanically couple the electrode plate to the farthest portion of the end portion.

[0224] 70. The electrode plate according to any one of Examples 50–69, wherein the first portion includes at least one support, and wherein the support of the at least one support is configured to be mechanically coupled to a distal portion of the conduit shaft.

[0225] 71. The electrode plate according to any one of Examples 50–70, wherein: The electrode plate includes a bonded portion at the proximal end of the electrode plate; The keying portion is configured to engage with the coupling element at the distal portion of the conduit shaft; and The bonding portion and the coupling element are configured to mechanically couple the electrode plate to the distal portion of the conduit shaft.

[0226] 72. The electrode plate according to any one of Examples 50–71 further includes at least one eye configured to receive a fastener, such that the electrode plate can be mechanically coupled to another electrode plate.

[0227] 73. The electrode plate according to Example 72, wherein: The active component includes multiple pillars; and The at least one eyelet is directly connected to at least one of the plurality of supports.

[0228] 74. The electrode plate according to Example 73, wherein the at least one support includes a bend such that the eye is not flush with the other supports of the plurality of supports.

[0229] 75. The electrode plate according to any one of Examples 50–74, wherein the second portion is not insulated.

[0230] in conclusion

[0231] The detailed description of the embodiments of this technology above is not intended to be exhaustive or to limit the technology to the precise forms disclosed above. Although specific embodiments and examples of the technology have been described above for illustrative purposes, as those skilled in the art will recognize, various equivalent modifications can be made within the scope of this technology. For example, although the steps are presented in a given order, alternative embodiments may perform the steps in a different order. Furthermore, the various embodiments described herein may be combined to provide further embodiments.

[0232] The systems and methods described herein may be provided in the form of a tangible and non-transitory machine-readable medium or a medium on which instructions are recorded for execution by a processor or computer (such as a hard disk drive, hardware memory, etc.). The instruction set may include multiple commands instructing a computer or processor to perform specific operations, as described in the various embodiments herein. The instruction set may be in the form of a software program or application. Computer storage media may include volatile and non-volatile media, as well as removable and non-removable media, for storing information such as computer-readable instructions, data structures, program modules, or other data. Computer storage media may include, but is not limited to, RAM, ROM, EPROM, EEPROM, flash memory or other solid-state storage technologies, CD-ROM, DVD, or other optical storage, disk storage, or any other hardware media available for storing desired information and accessible by system components. Components of the system may communicate with each other via wired or wireless communication. Components may be separate from each other, or multiple combinations of components may be integrated together into a monitor or processor, or contained within a workstation having standard computer hardware (e.g., processor, circuitry, logic circuitry, memory, etc.). The system may include processing devices such as microprocessors, microcontrollers, integrated circuits, control units, storage media, and other hardware.

[0233] As will be understood from the foregoing, specific embodiments of the present technology are described herein for illustrative purposes, but well-known structures and functions are not shown or described in detail to avoid unnecessarily obscuring the description of embodiments of the present technology. To the extent that any material incorporated herein by reference conflicts with this disclosure, this disclosure shall prevail. Where the context permits, singular or plural terms may also include plural or singular terms respectively. Furthermore, unless the word “or” is explicitly limited to referring only to a single item in a list of two or more items that does not include other items, its use in such lists shall be construed as including (a) any single item in the list, (b) all items in the list, or (c) any combination of items in the list. As used herein, the phrase “and / or” in “A and / or B” refers to A alone, B alone, and both A and B. Additionally, the terms “comprising,” “including,” “having,” and “with” throughout mean including at least one or more of the stated features, such that no additional number of the same features and / or other features of the same type are excluded. Furthermore, as used herein, the term "substantially" refers to the complete or near-complete extent or degree of an action, characteristic, property, state, structure, item, or result. For example, a "substantially" closed object means that the object is either completely closed or nearly completely closed. In some cases, the exact permissible deviation from absolute completeness may depend on the specific circumstances. However, in general, a degree of near-completeness will have the same overall result as achieving absolute or complete completeness. When used in a negative sense, the use of "substantially" also applies to referring to a complete or near-complete lack of an action, characteristic, property, state, structure, item, or result.

[0234] As will also be understood from the foregoing, various modifications can be made without departing from the present technology. For example, multiple components of the technology can be further divided into sub-components, or multiple components and functions of the technology can be combined and / or integrated. Furthermore, while advantages associated with certain embodiments of the present technology have been described in the context of these embodiments, other embodiments may also exhibit these advantages, and not all embodiments need to exhibit these advantages to fall within the scope of the present technology. Therefore, this disclosure and related technologies may include other embodiments not explicitly shown or described herein.

Claims

1. A catheter, comprising: A shaft having a proximal portion and a distal portion; and The distal portion, mechanically coupled to the distal portion of the shaft, includes a plurality of longitudinal mesh electrode plates, each formed of a scalable and compressible material and defining a single ablation electrode through which blood can flow. The mesh electrode plates are coupled together to define a scalable portion configured to conform to and surround the pulmonary vein orifice. The catheter is configured to deliver monopolar pulsed field ablation from the mesh electrode plates to one or more body blocks via sequential power supply to each of the plurality of mesh electrode plates.

2. The catheter according to claim 1, wherein, The scalable and compressible material is a shape memory alloy.

3. The catheter according to claim 2, wherein, Each longitudinal mesh electrode plate is formed from sheet or tube of shape memory alloy.

4. The catheter according to claim 1, wherein, Each mesh electrode plate is configured to define the ablation electrode along most of the longitudinal length of the respective mesh electrode plate.

5. The catheter according to claim 1, wherein, The end portion further includes a deployable member mechanically coupled to the expandable portion at the farthest portion of the end portion, and wherein the expandable portion encloses at least a portion of the deployable member between the farthest portion of the shaft and the farthest portion of the end portion.

6. The catheter according to claim 5, wherein, The deployable component is retractable.

7. The catheter according to claim 5, wherein, The expandable portion is configured to expand and compress by moving proximal and distal to the axis defined by the axis, respectively, via the unfolding member.

8. The catheter according to claim 1, wherein, It also includes a plurality of magnetic coil sensors located on the expandable portion and configured to determine the expansion state and position of the expandable portion.

9. The catheter according to claim 1, wherein, The expandable portion is pear-shaped or onion-shaped and includes an insulating neck portion and an active body portion distal to the insulating neck portion; The active main body includes modular electrodes; and The insulating neck portion is mechanically coupled to the distal portion of the shaft.

10. The catheter according to claim 1, wherein, Each of the mesh electrode plates includes at least one eyelet, and at least one fastener holds adjacent mesh electrode plates of the expandable portion together via the respective eyelet.

11. The catheter according to claim 10, wherein, The at least one fastener includes at least one sensor, and / or the at least one sensor includes at least one electrode and / or a temperature measuring device.

12. The catheter according to claim 10, wherein, The at least one eyelet of each of the mesh electrode plates is directly connected to at least one support, and wherein the at least one support includes a bend such that the at least one sensor is recessed relative to the exterior of the expandable portion when the adjacent mesh electrode plates are held together by the at least one fastener.

13. The catheter according to claim 10, wherein, Electrical leads extend from the at least one sensor and enter the shaft within the interior of the expandable portion, wherein the sensor is formed and / or positioned thereon by the electrical leads within the interior of the expandable portion.

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