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

Abstract

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

Description

[Technical field]

[0001] (CROSS REFERENCE TO RELATED APPLICATIONS) This application claims the benefit of U.S. Provisional Patent Application No. 62 / 948,736, filed December 16, 2019, which is incorporated by reference in its entirety. [Background technology]

[0002] (background) Atrial fibrillation is an abnormal heart rhythm characterized by rapid or irregular beating of the atrial chambers of the heart. One possible cause of atrial fibrillation is overfiring of the heart induced by the pulmonary veins that carry oxygenated blood from the individual lungs to the left atrium of the heart. Thus, 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 ablative energy around the mouths of the pulmonary veins. Summary of the Invention [Means for solving the problem]

[0003] BRIEF DESCRIPTION OF THE DRAWINGS Many aspects of the present disclosure can be better understood with reference to the following drawings. The components in the drawings are not necessarily to scale. Instead, emphasis is placed upon clearly illustrating the principles of the present disclosure. The drawings should not be taken to limit the disclosure to the specific embodiments depicted, but are merely for purposes of explanation and understanding. The present invention provides, for example, the following items. (Item 1) A catheter comprising: a shaft having a proximal end portion and a distal end portion; a tip section mechanically coupled to the distal end portion of the shaft, the tip section including a plurality of mesh electrode panels that together define an expandable portion; A catheter comprising: (Item 2) 2. The catheter of claim 1, wherein the mesh electrode panels each comprise: (i) a first insulating portion and a second insulating portion axially distributed along the mesh electrode panel; and (ii) an active portion between the first insulating portion and the second insulating portion. (Item 3) 2. The catheter of claim 1, wherein the mesh electrode panels each comprise: (i) a first insulating portion; and (ii) an active portion distal to the first insulating portion. (Item 4) 2. The catheter of claim 1, wherein the mesh electrode panels each include a plurality of struts, a first subset of the plurality of struts defining a plurality of cells. (Item 5) 5. The catheter of claim 4, wherein the plurality of cells at least partially define an open area of ​​the expandable portion through which fluid, blood, or a combination thereof can flow. (Item 6) 2. The catheter of claim 1, wherein the tip section further comprises a deployment member mechanically coupled to the expandable portion at a distal-most portion of the tip section, the expandable portion encasing at least a portion of the deployment member between the distal end portion of the shaft and the distal-most portion of the tip section. (Item 7) 7. The catheter of claim 6, wherein the deployment member is telescopic. (Item 8) 7. The catheter of claim 6, wherein the expandable portion is configured to expand via proximal movement of the deployment member and to compress via distal movement of the deployment member along an axis defined by the shaft. (Item 9) 7. The catheter of claim 6, wherein the deployment member defines a lumen configured to receive a guidewire. (Item 10) 7. The catheter of claim 6, wherein the deployment member defines a lumen, the lumen configured to transport fluid between at least the proximal end portion of the shaft and the distal-most portion of the tip section. (Item 11) 7. The catheter of claim 6, wherein the deployment member defines a lumen and includes a plurality of pores, the plurality of pores configured to radially distribute fluid from within the expandable portion toward an inner surface of the expandable portion. (Item 12) 7. The catheter of claim 6, wherein the deployment member includes at least one ring electrode, the at least one ring electrode being positioned on the portion of the deployment member between the distal end portion of the shaft and the distal-most portion of the tip section. (Item 13) the expandable portion is pear-shaped or onion-shaped and includes an insulating neck portion and an actuating body portion distal to the insulating neck portion; the actuating body portion includes a modular electrode; the insulating neck portion is mechanically coupled to the distal end portion of the shaft. Item 1. The catheter according to item 1. (Item 14) the expandable portion further includes a nose portion distal to the actuating body portion and the insulating neck portion; the nose portion is mechanically coupled to a distal-most portion of the tip section. Item 14. The catheter according to item 13. (Item 15) 2. The catheter of claim 1, wherein the mesh electrode panels each include at least one small hole and at least one fastener holds adjacent mesh electrode panels of the expandable portion together via a corresponding small hole. (Item 16) Item 16. The catheter of item 15, 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 temperature measuring device. (Item 17) Item 17. The catheter of item 16, wherein the at least one pore of each of the mesh electrode panels is directly connected to at least one strut, the at least one strut including a bend such that the at least one sensor is recessed relative to an exterior of the expandable portion when the adjacent mesh electrode panels are held together via the at least one fastener. (Item 18) Item 17. The catheter of item 16, wherein an electrical lead extends from the at least one sensor within the expandable portion into the shaft, and a sensor is formed by and / or positioned on the electrical lead within the expandable portion. (Item 19) Item 14. The catheter of item 1, further comprising a displacement measuring device configured to measure the displacement of a deployment member mechanically coupled to the expandable portion and determine a shape of the expandable portion. (Item 20) Item 14. The catheter of item 1, further comprising a shaft electrode mounted to the distal end portion of the shaft. (Item 21) 2. The catheter of claim 1, wherein the mesh electrode panels of the expandable portion are electrically isolated from one another such that electrical energy can be delivered from any one of the mesh electrode panels independently from any other of the mesh electrode panels. (Item 22) each of the mesh electrode panels includes a key portion at a proximal and / or distal end of the mesh electrode panel; the key portion is configured to mate with a first fitting at the distal end portion of the shaft and / or with a second fitting at a distal-most portion of the tip section; the key portion and the first coupler and / or the second coupler are configured to mechanically couple the mesh electrode panel to the distal end portion of the shaft and / or to the distal-most portion of the tip section. Item 1. The catheter according to item 1. (Item 23) At least one mesh electrode panel a first strut mechanically coupled to a deployment member at a distal-most portion of the tip section; a second strut coupled to the first strut at a distal-most portion of the second strut; a third strut coupled to the first strut at a distal-most portion of the third strut; 2. The catheter according to item 1, comprising: (Item 24) each of the mesh electrode panels includes at least one strut mechanically coupled to a deployment member at a distal-most portion of the tip section; the at least one strut of each of the mesh electrode panels emerges distally from the distal-most portion of the tip section. Item 1. The catheter according to item 1. (Item 25) At least one of the mesh electrode panels comprises: a first strut mechanically coupled to the distal end portion of the shaft; a second strut coupled to the first strut at a proximal-most portion of the second strut; a third strut coupled to the first strut at a proximal-most portion of the third strut; 2. The catheter according to item 1, comprising: (Item 26) 2. The catheter of claim 1, wherein at least one mesh electrode panel includes a proximal portion, a distal portion, and an intermediate portion between the proximal and distal portions, the intermediate portion being wider than the proximal and distal portions. (Item 27) each of the mesh electrode panels comprises a plurality of posts; a first subset of the plurality of struts defining a plurality of cells of the expandable portion; the expandable portion includes a distal section, a proximal section, and an equator between the distal section and the proximal section; the expandable portion includes a greater number of the plurality of cells around the equator than around the distal section and / or around the proximal section. Item 1. The catheter according to item 1. (Item 28) each of the mesh electrode panels comprises a plurality of posts; a first subset of the plurality of struts defining a plurality of cells of the expandable portion; At least one cell of the plurality of cells is formed by (i) a first strut of the first subset that belongs to a first mesh electrode panel of the mesh electrode panels, and (ii) a second strut of the first subset that belongs to a second mesh electrode panel of the mesh electrode panels that is different from the first mesh electrode panel. Item 1. The catheter according to item 1. (Item 29) each of the mesh electrode panels comprises a plurality of posts; a first subset of the plurality of struts defining a plurality of cells of the expandable portion; a distal-most cell of the plurality of cells is formed by (i) a first strut of the first subset that belongs to a first mesh electrode panel of the mesh electrode panels, and (ii) a second strut of the first subset that belongs to a second mesh electrode panel of the mesh electrode panels that is different from the first mesh electrode panel. Item 1. The catheter according to item 1. (Item 30) each of the mesh electrode panels comprises a plurality of posts; a first subset of the plurality of struts defining a plurality of cells of the expandable portion; a most proximal cell of the plurality of cells is formed by (i) a first strut of the first subset that belongs to a first mesh electrode panel of the mesh electrode panels, and (ii) a second strut of the first subset that belongs to a second mesh electrode panel of the mesh electrode panels that is different from the first mesh electrode panel. Item 1. The catheter according to item 1. (Item 31) Each of the electrode panels comprises a plurality of posts; the plurality of struts includes (i) a first subset of struts having one or more first lengths and / or one or more first widths, and (ii) a second subset of struts having one or more second lengths that are shorter than the one or more first lengths and / or one or more second widths that are narrower than the one or more first widths; the first subset of struts includes a distal-most strut of the plurality of struts and / or a proximal-most strut of the plurality of struts; Item 1. The catheter according to item 1. (Item 32) each of the mesh electrode panels comprises a plurality of posts; the plurality of struts defining a plurality of cells in the expandable portion; At least one cell of the plurality of cells is formed by at least four struts. Item 1. The catheter according to item 1. (Item 33) At least one mesh electrode panel comprises a plurality of struts; a proximal strut of the plurality of struts includes a first portion having a first width and a second portion having a second width less than the first width; Item 1. The catheter according to item 1. (Item 34) 2. The catheter of claim 1, wherein the tip section further comprises at least one localization coil sensor configured to measure position and / or orientation information of the tip section. (Item 35) Item 14. The catheter of item 1, wherein the expandable portion, in the absence of an external force, exhibits a deployed state having a diameter greater than a maximum diameter of the shaft. (Item 36) 1. A method of treating target tissue at a treatment site within a patient using a tip section of a catheter, comprising: determining an effective surface area of ​​the tip section of the catheter, the tip section including a plurality of mesh electrode panels that are electrically isolated from one another and that together define an expandable portion of the tip section; delivering energy to the target tissue at the treatment site; and wherein the energy is delivered via at least one mesh electrode panel of the expandable portion based at least in part on the determined effective surface area. (Item 37) Item 37. The method of item 36, wherein determining the effective surface area includes determining a position and / or orientation of the tip section. (Item 38) Determining the position and / or orientation of the tip segment may include visualizing the tip section under fluoroscopy; and / or receiving at least one signal from the tip section's localization coil sensor, the at least one signal indicative of a position of the localization coil sensor in three-dimensional space and / or indicative of a pitch, yaw, and / or roll of the localization coil sensor; 38. The method according to item 37, comprising: (Item 39) 37. The method of claim 36, wherein delivering the energy to the at least one mesh electrode panel of the expandable portion comprises delivering the energy to the at least one mesh electrode panel based at least in part on a location of the at least one mesh electrode panel within the patient's anatomy. (Item 40) Item 37. The method of item 36, wherein determining the effective surface area comprises determining a degree of deployment and / or deformation of the expandable portion. (Item 41) Determining the extent of deployment and / or deformation of the expandable portion includes: visualizing the tip section under fluoroscopy; and / or receiving one or more signals from two or more electrodes carried on the expandable portion, the one or more signals indicative of an impedance between the two or more electrodes; The method according to item 40, comprising: (Item 42) 37. The method of claim 36, wherein determining the effective surface area comprises determining an extent of contact between the at least one mesh electrode panel and tissue. (Item 43) 37. The method of claim 36, wherein delivering the energy to the at least one mesh electrode panel of the expandable portion comprises delivering a defined amount of energy to the at least one mesh electrode panel to achieve a target current density of energy delivered through the at least one mesh electrode panel to tissue in contact with the at least one mesh electrode panel. (Item 44) Item 37. The method of item 36, wherein delivering the energy to the at least one mesh electrode panel comprises delivering the energy to all of the mesh electrode panels of the expandable portion. (Item 45) Item 45. The method of item 44, wherein delivering the energy to all of the mesh electrode panels of the expandable portion comprises separately and sequentially delivering the energy to each mesh electrode panel of the expandable portion. (Item 46) Item 45. The method of item 44, wherein delivering the energy to all of the mesh electrode panels of the expandable portion comprises separately and sequentially delivering the energy to subgroups of the mesh electrode panels of the expandable portion. (Item 47) 37. The method of claim 36, wherein the at least one mesh electrode panel comprises a subset of the mesh electrode panels of the expandable portion, the subset comprising fewer than all of the mesh electrode panels of the expandable portion, and further wherein delivering the energy to the at least one mesh electrode panel comprises delivering the energy to only the subset of mesh electrode panels. (Item 48) 37. The method of claim 36, wherein delivering energy to the at least one mesh electrode panel comprises delivering radio frequency (RF) energy and / or pulsed magnetic field energy to the at least one mesh electrode panel. (Item 49) receiving one or more signals from one or more temperature measuring devices mounted on the expandable portion, the one or more signals indicative of a temperature of tissue in contact with the at least one mesh electrode panel; adjusting the energy delivered to the at least one mesh electrode panel based at least in part on the received one or more temperature signals; and / or delivering irrigation fluid to the tissue in contact with the at least one mesh electrode panel; 37. The method of claim 36, further comprising: (Item 50) 1. An electrode panel for use in forming an expandable portion of a tip section of a catheter, comprising: a first section at a proximal end portion of the electrode panel; a second section at a distal end portion of the electrode panel; and an actuating section between the first section and the second section; and An electrode panel comprising: (Item 51) Item 51. The electrode panel of item 50, wherein the first section is insulated. (Item 52) Item 51. The electrode panel of item 50, wherein at least a portion of the second section is insulated. (Item 53) the actuation section includes a plurality of struts; the plurality of struts defining a plurality of cells; Item 51. The electrode panel according to item 50. (Item 54) Item 54. The electrode panel of item 53, wherein the plurality of cells at least partially define an open area of ​​the electrode panel through which fluid, blood, or a combination thereof can flow. (Item 55) Item 54. The electrode panel of item 53, wherein at least one cell of the plurality of cells is defined by at least four pillars of the plurality of pillars. (Item 56) the actuation section includes a plurality of struts; the first section includes at least one strut; At least one strut of the first section has a first length and / or a first width; a strut of the plurality of struts has a second length less than the first length and / or a second width less than the first width; Item 51. The electrode panel according to item 50. (Item 57) the actuation section includes a plurality of struts; the second section includes at least one strut; the at least one strut of the second section has a first length and / or a first width; a strut of the plurality of struts has a second length less than the first length and / or a second width less than the first width; Item 51. The electrode panel according to item 50. (Item 58) the first section includes at least one strut; the at least one strut includes a first portion having a first width and a second portion having a second width narrower than the first width; Item 51. The electrode panel according to item 50. (Item 59) Item 51. The electrode panel of item 50, wherein the active section is wider than the first section. (Item 60) Item 51. The electrode panel of item 50, wherein the active section is wider than the second section. (Item 61) Item 51. The electrode panel of item 50, wherein the first section includes a single post. (Item 62) the first section includes a single strut; the actuation section includes a first strut, the first strut being directly coupled to the single strut at a proximal-most portion of the first strut; the actuation section further includes a second strut, the second strut being directly coupled to the single strut at a proximal-most portion of the second strut; Item 51. The electrode panel according to item 50. (Item 63) the first section includes a single strut; the actuation section includes a first strut, the first strut being directly coupled to the single strut at a distal end of the single strut; the actuation section includes a second strut, the second strut being directly coupled to the single strut at a distal end of the single strut; Item 51. The electrode panel according to item 50. (Item 64) Item 51. The electrode panel of item 50, wherein the second section includes a single post. (Item 65) the second section includes a single strut; the actuation section includes a first strut coupled directly to the single strut at a distal-most portion of the first strut; the actuation section further includes a second strut, the second strut being directly coupled to the single strut at a distal-most portion of the second strut; Item 51. The electrode panel according to item 50. (Item 66) the second section includes a single strut; the actuation section includes a first strut, the first strut being directly coupled to the single strut at a proximal end of the single strut; the actuation section includes a second strut, the second strut being directly coupled to the single strut at a proximal end of the single strut; Item 51. The electrode panel according to item 50. (Item 67) 51. The electrode panel of claim 50, wherein the second section includes at least one strut, a strut of the at least one strut being configured to be mechanically coupled to a distal-most portion of the tip section of the catheter. (Item 68) Item 68. The electrode panel of item 67, wherein the strut of the at least one strut is configured to emerge distally from the distal-most portion of the tip section when mechanically coupled to the distal-most portion of the tip section. (Item 69) the electrode panel including a key portion at a distal end of the electrode panel; the key portion is configured to mate with a coupler at a distal-most portion of the catheter tip section; the key portion and the coupler are configured to mechanically couple the electrode panel to the distal-most portion of the tip section. Item 51. The electrode panel according to item 50. (Item 70) Item 51. The electrode panel of item 50, wherein the first section includes at least one strut, a strut of the at least one strut being configured to be mechanically coupled to a distal end portion of a catheter shaft. (Item 71) the electrode panel including a key portion at a proximal end of the electrode panel; the key portion is configured to mate with a fitting at a distal end portion of a catheter shaft; the key portion and the coupler are configured to mechanically couple the electrode panel to the distal end portion of the catheter shaft. Item 51. The electrode panel according to item 50. (Item 72) Item 51. The electrode panel of item 50, further comprising at least one small aperture configured to receive a fastener such that the electrode panel can be mechanically coupled to another electrode panel. (Item 73) the actuation section includes a plurality of struts; the at least one pore is directly connected to at least one strut of the plurality of struts; Item 73. The electrode panel according to item 72. (Item 74) Item 74. The electrode panel of item 73, wherein the at least one strut includes a bend such that the perforation is not coplanar with other struts of the plurality of struts. (Item 75) Item 51. The electrode panel of item 50, wherein the second section is not insulated. [Brief description of the drawings]

[0004] [Figure 1] FIG. 1 is a schematic diagram of a system, configured in accordance with various embodiments of the present technology, for treating a human patient.

[0005] [Diagram 2] FIG. 2 is a perspective view of a medical device of the system of FIG. 1, configured in accordance with various embodiments of the present technology.

[0006] [Figure 3A] 3A and 3B are schematic illustrations of a tip section of the medical device of FIG. 2, configured in accordance with various embodiments of the present technology. [Figure 3B] 3A and 3B are schematic illustrations of a tip section of the medical device of FIG. 2, configured in accordance with various embodiments of the present technology.

[0007] [Figure 4] FIG. 4 is a schematic illustration of a deployment member of the medical device of FIG. 2, configured in accordance with various embodiments of the present technology.

[0008] [Diagram 5] FIG. 5 is a top view of a distal-most portion of the tip section of the medical device of FIG. 2, configured in accordance with various embodiments of the present technology.

[0009] [Figure 6A] 6A and 6B are schematic illustrations of a tip section of a medical device in a compressed and deployed state, respectively, in accordance with various embodiments of the present technology. [Figure 6B] 6A and 6B are schematic illustrations of a tip section of a medical device in a compressed and deployed state, respectively, in accordance with various embodiments of the present technology.

[0010] [Figure 7A]7A and 7B are schematic illustrations of modular electrode panels of the tip section of the medical device of FIG. 2 configured in accordance with various embodiments of the present technology. [Figure 7B] 7A and 7B are schematic illustrations of modular electrode panels of the tip section of the medical device of FIG. 2 configured in accordance with various embodiments of the present technology.

[0011] [Figure 8A] 8A is an exploded view of eyelets and corresponding rivets for connecting multiple panels of a modular electrode of a medical device, as shown in FIG. 2, configured in accordance with an embodiment of the present technology.

[0012] [Figure 8B] 8B is a schematic illustration of eyelets and rivets for connecting multiple panels of electrodes of the tip section of the medical device of FIG. 2, constructed in accordance with various embodiments of the present technology.

[0013] [Figure 8C] 8C is a cross-sectional view of a rivet connecting two eyelets of a panel of electrodes of the tip section of the medical device of FIG. 2 configured in accordance with various embodiments of the present technology.

[0014] [Figure 8D] 8D is a schematic illustration of an assembled tip section of the medical device of FIG. 2, constructed in accordance with various embodiments of the present technology.

[0015] [Figure 9A] 9A and 9B are exploded and partial cross-sectional views, respectively, of a nose portion of a tip section of a medical device of FIG. 2 configured in accordance with various embodiments of the present technology. [Figure 9B] 9A and 9B are exploded and partial cross-sectional views, respectively, of a nose portion of a tip section of a medical device of FIG. 2 configured in accordance with various embodiments of the present technology.

[0016] [Figure 10A]10A and 10B are exploded and side views, respectively, of a proximal portion of a tip section of the medical device of FIG. 2, configured in accordance with various embodiments of the present technology. [Figure 10B] 10A and 10B are exploded and side views, respectively, of a proximal portion of a tip section of the medical device of FIG. 2, configured in accordance with various embodiments of the present technology.

[0017] [Figure 11A] 11A and 11B are schematic illustrations of a tip section of a medical device constructed in accordance with various embodiments of the present technology in a deployed state. [Figure 11B] 11A and 11B are schematic illustrations of a tip section of a medical device constructed in accordance with various embodiments of the present technology in a deployed state.

[0018] [Figure 12A] 12A and 12B are top and top perspective views, respectively, of the distal-most portion of the tip section of FIGS. 11A and 11B. [Figure 12B] 12A and 12B are top and top perspective views, respectively, of the distal-most portion of the tip section of FIGS. 11A and 11B.

[0019] [Figure 13] FIG. 13 is a side perspective view of the tip section of FIGS. 11A-12B.

[0020] [Figure 14A] 14A-14C are cross-sectional, side perspective, and top perspective views, respectively, of a portion of the tip section of FIGS. 11A-13, diagrammatically illustrating how mesh electrode panels can be attached to form an expandable portion of the tip section 124, in accordance with various embodiments of the present technology. [Figure 14B]14A-14C are cross-sectional, side perspective, and top perspective views, respectively, of a portion of the tip section of FIGS. 11A-13, diagrammatically illustrating how mesh electrode panels can be attached to form an expandable portion of the tip section 124, in accordance with various embodiments of the present technology. [Figure 14C] 14A-14C are cross-sectional, side perspective, and top perspective views, respectively, of a portion of the tip section of FIGS. 11A-13, diagrammatically illustrating how mesh electrode panels can be attached to form an expandable portion of the tip section 124, in accordance with various embodiments of the present technology.

[0021] [Figure 15] FIG. 15 is a schematic illustration of a tip section of a medical device configured in accordance with various embodiments of the present technology.

[0022] [Figure 16] FIG. 16 is a schematic illustration of a tip section of a medical device, configured in accordance with various embodiments of the present technology, positioned at the ostium of a pulmonary vein in a patient's anatomy, in accordance with various embodiments of the present technology.

[0023] [Figure 17] FIG. 17 is a flow diagram illustrating a method of positioning a tip section of a medical device configured in accordance with various embodiments of the present technology at a treatment site within a patient's anatomy in accordance with various embodiments of the present technology.

[0024] [Figure 18] FIG. 18 is a flow diagram illustrating a method of diagnosing and / or treating tissue at a treatment site within a patient's anatomy, in accordance with various embodiments of the present technology. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0025] (Detailed Description) A. Overview As discussed above, atrial fibrillation is an abnormal heart rhythm that may be caused by overfiring of the heart induced by the pulmonary veins. Thus, a common treatment for atrial fibrillation is to electrically isolate one or more pulmonary veins from the left atrium of the heart using a minimally invasive radiofrequency, cryotherapy, or pulsed magnetic field ablation catheter. In particular, a catheter is used to deliver energy and form a lesion on the wall of the heart around the mouth of the pulmonary vein. The energy applied to the cardiac tissue at the treatment site blocks the electrical activity of the tissue. Thus, the abnormal electrical signals in the pulmonary veins are prevented from propagating through the blocked tissue into the heart, thereby preventing atrial fibrillation.

[0026] The inventors have recognized several challenges incurred when electrically isolating the pulmonary veins from the left atrium of the heart. For example, applying energy to the walls of the pulmonary veins (as opposed to only the walls of the heart in the left atrium around the pulmonary vein ostium) may cause undesired constriction in the pulmonary veins or fail to isolate all of the tissue involved in atrial fibrillation. Thus, correct positioning of the catheter tip at the ostium of the pulmonary veins is important prior to applying energy. In addition, pulmonary veins vary in size between patients as well as across a single patient's heart. Thus, the catheter tip should be expandable to account for the different sizes of pulmonary veins. Furthermore, because the catheter tip varies in deployed size, the effective surface area of ​​the tip through which energy is delivered also varies. As a result, the current density applied through the catheter tip also varies. For this reason, fine control over the amount of energy applied through the catheter tip, as well as the portion of the tip that is energized to apply the energy (both of which are absent in conventional pulmonary vein isolation catheters), is required to effectively match energy delivery to the patient's anatomy or other treatment conditions and to avoid undesirable collateral damage to the anatomical structure (e.g., an individual's esophagus).

[0027] To address these challenges, the inventors have developed a pulmonary vein isolation catheter having a tip section including an expandable portion formed from several mesh electrode panels. In some embodiments, the expandable portion includes an insulated neck portion, an active modular electrode, and / or a nose portion, which may or may not be insulated. The nose portion is configured to fit at least partially within the pulmonary vein and facilitate proper positioning of the modular electrode relative to the cardiac tissue around the ostium of the pulmonary vein. Additionally, the expandable portion can be expanded to various degrees between a fully collapsed state (e.g., to allow passage through an introducer sheath) and a fully deployed state to account for various sizes of pulmonary veins. In these and other embodiments, the mesh electrode panels that together form the expandable portion are electrically insulated from each other and individually energizable. Thus, it is expected that a pulmonary vein isolation catheter constructed in accordance with the present technology will provide fine control of the portion of the modular electrode used to deliver energy to tissue, as well as fine control of the amount of energy delivered to the region of tissue around the modular electrode of the expandable portion.

[0028] Specific details of some embodiments of the present technology are described herein with reference to Figures 1-18. Although many of the embodiments are described with respect to pulmonary vein isolation catheters and associated devices, systems, and methods, other applications and other embodiments are within the scope of the present technology in addition to those described herein. For example, unless otherwise specified or made clear from the context, the devices, systems, and methods of the present technology can be used for any of a variety of medical procedures, such as procedures performed on hollow anatomical structures of a patient, more specifically, procedures for stimulating, electrically isolating, or otherwise treating tissue within and / or proximal to the anatomical structures. Thus, for example, the devices, systems, and methods of the present disclosure can be used as part of a medical procedure associated with the diagnosis, treatment, or both of certain cardiac conditions (e.g., arrhythmias). Additionally or alternatively, the devices, systems, and methods of the present disclosure can be used in one or more medical procedures associated with other interventional procedures involving ablation of target tissues (e.g., renal and / or carotid denervation procedures).

[0029] It should be noted that other embodiments in addition to those disclosed herein are within the scope of the present technology. Furthermore, embodiments of the present technology can have configurations, components, and / or procedures different from those shown or described herein. Also, those skilled in the art will understand that embodiments of the present technology can have configurations, components, and / or procedures in addition to those shown or described herein, and that these and other embodiments can be without some of the configurations, components, and / or procedures shown or described herein without departing from the present technology.

[0030] As used herein, the term "physician" shall be understood to include any type of medical personnel who may perform or assist in a medical procedure, and thus include doctors, nurses, medical technicians, other similar personnel, and any combination thereof. Additionally or alternatively, as used herein, the term "medical procedure" shall be understood to include any manner and form of diagnosis, treatment, or both, including any preparatory activity associated with such diagnosis, treatment, or both. Thus, for example, the term "medical procedure" shall be understood to include any manner and form of movement or positioning of a medical device within an anatomical cavity. As used herein, the term "patient" shall be considered to include a human patient and / or a non-human (e.g., animal) patient on whom a medical procedure is being performed.

[0031] B. Selected Embodiments of Pulmonary Vein Isolation Catheters and Associated Devices, Systems, and Methods 1. Pulmonary Vein Isolation Catheter System 1 is a schematic diagram of a system 100 for treating a patient 102 configured in accordance with an embodiment of the present technology. In the arrangement shown in FIG. 1, the system 100 is used to perform a medical procedure (e.g., a pulmonary vein isolation procedure) on the patient 102. The system 100 can include a medical device 104 connected to an interface unit 108 via an extension cable 106. The interface unit 108 can 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 the storage medium 111 can be in electrical communication (e.g., wired communication, wireless communication, or both) with the processing unit 110. The storage medium 111 can store thereon computer-executable instructions for causing one or more processors of the processing unit 110 to perform one or more portions of the various methods described herein, unless otherwise indicated or made clear from the context. Additionally or alternatively, the storage medium 111 may store thereon computer-executable instructions for causing the processing unit 110 and / or the graphical user interface 109 to display various information collected by and / or related to the medical device 104.

[0032] The mapping system 112, the recording system 113, the fluid pump 114, and the generator 115 can be connected to the interface unit 108. The fluid pump 114 can be removably and fluidly connected to the medical device 104 via a fluid line 149. The generator 115 can also, or instead, be connected to one or more return electrodes 118, which are connected to the medical device 104 via one or more wires 148 and / or attached to the skin of the patient 102 via one or more wires 147. In use, electrical energy can be delivered from the generator 115 to the medical device 104, where it can ultimately be delivered to the tip section 124 (e.g., to a modular electrode (not shown in FIG. 1 ) of the tip section 124) to ablate, treat, or diagnose tissue at a treatment site, as described in more detail below. The mapping system 112 can be used prior to and / or during a medical procedure to map the patient's tissue and determine a region or regions of tissue requiring treatment. The recording system 113 can be used throughout the medical procedure, as well as before or after the procedure.

[0033] The medical device 104 can be any of a variety of different medical devices known in the art (e.g., for diagnosis, treatment, or both). In the illustrated embodiment, the medical device 104 is a catheter 104 having a handle 120, a shaft 122, and a tip section 124. The tip section 124 generally includes any portion of the catheter 104 that directly or indirectly engages tissue for treatment, diagnosis, or both purposes, and thus can include all manners and types of contact and / or non-contact interactions with tissue known in the art. For example, the tip section 124 can include contact and / or non-contact interactions with tissue in the form of energy interactions (e.g., electrical energy, ultrasonic energy, light energy, and any combination thereof), and can also or instead include measurements of electrical signals emanating from the tissue. Thus, for example, the tip section 124 can deliver energy (e.g., electrical energy) to tissue within an anatomical structure as part of any number of procedures, including treatment (e.g., radio frequency (RF) ablation, irreversible electroporation, pulsed magnetic field ablation, etc.), diagnosis (e.g., mapping), or both.

[0034] The tip section 124 and at least a portion of the shaft 122 can be inserted into the anatomy (e.g., the heart) of the patient 102 via a vein or artery in the patient's leg or arm. In particular, the tip section 124 can be inserted into the anatomy (e.g., the heart) of the patient 102 via an introducer (e.g., Abbott Agilis TM A steerable sheath (such as a steerable introducer) and / or a guidewire (not shown in FIG. 1 ) can be used to deliver the catheter to the treatment site (e.g., the ostium of a pulmonary vein in the left atrium of the patient's heart). Injection of contrast and / or further advancement of the guidewire may be used in some embodiments to verify placement at the treatment site, as described in more detail below.

[0035] 2 is a perspective view of the catheter 104 of the system 100 of FIG. 1 configured in accordance with various embodiments of the present technology. As shown in FIG. 2, the handle 120 of the catheter 104 can be coupled to a proximal end portion 230 of the shaft 122, and the tip section 124 can be coupled to a distal end portion 232 of the shaft 122 opposite the proximal end portion 230. The tip section 124 includes an expandable portion 250 and a deployment member 235. As used herein, the terms "expandable" and "deformable" are used synonymously unless otherwise specified or made clear by the context. Thus, for example, it should be understood that the expandable portion 250 is deformable unless otherwise specified. The deployment member 235 extends from a distal-most portion 240 of the tip section 124 to at least the proximal end portion 230 of the shaft 122.

[0036] The shaft 122 can be formed from a number of different biocompatible materials that provide the shaft 122 with sufficient strength and flexibility to allow the shaft 122 to be passed through the patient's blood vessels. Examples of suitable materials from which the shaft 122 can be formed include polyether block amides (e.g., Pebax®, commercially available from Arkema, Colombes, France), nylon, polyurethane, Pellethane® (commercially available from Lubrizol Corporation, Wickliffe, Ohio), and silicone. In some implementations, the shaft 122 includes a number of different materials along its length. The materials can be selected, for example, to provide the shaft 122 with increased flexibility at the distal end compared to the proximal end. The shaft 122 can also, or instead, include a tubular braided element that provides torsional stiffness to one or more regions of the shaft 122 while maintaining bending flexibility thereto. Additionally or alternatively, the shaft material can include a radiopaque agent, such as barium sulfate or bismuth, to facilitate fluoroscopic visualization.

[0037] In these and other embodiments, the shaft 122 can define a lumen that can be in fluid communication with the fluid pump 114 (FIG. 1). For example, the shaft 122, in some embodiments, defines a lumen that extends from a proximal end portion 230 of the shaft 122 to a distal end portion 232 of the shaft 122. The lumen can be in fluid communication with the fluid pump 114 via a fluid line 149 (FIG. 1) and a fluid line connector 249 of the handle 120 such that fluid (e.g., saline, contrast, etc.) can be pumped from the fluid pump 114 to the tip section 124. Additionally or alternatively, the shaft 122 may include electrical wires (such as any one or more of the wires 148 shown in FIG. 1 ) extending along the shaft 122 for carrying signals between the tip section 124, the handle 120, and / or the interface unit 108 and / or for carrying power (e.g., electrical energy) from the generator 115 to the tip section 124.

[0038] The handle 120 can include a housing 245 and an actuating portion 246. In use, the actuating portion 246 can be operated to expand or retract (e.g., contract) the deployment member 235 and to deploy (e.g., expand, restore, etc.) or compress the tip section 124 of the catheter 104, as described in more detail below. In these and other embodiments, the handle 120 can include one or more additional actuating portions (not shown), such as one or more actuating portions that can be operated to deflect the shaft distal end portion 232 and facilitate positioning the tip section 124 into contact with tissue at a treatment site. The handle 120 can also or instead be coupled to a fluid line connector 249 and / or an electrical connector 248 for delivery of fluid and / or electrical signals (e.g., electrical energy) along the shaft 122 to / from the tip section 124, respectively.

[0039] 3A and 3B are schematic diagrams of tip section 124. As shown, expandable portion 250 of tip section 124 can be generally "pear" shaped, having a nose portion 355, a neck portion 357 (FIG. 3B), and an actuating body portion 352 (hereafter referred to as "modular electrode 352"). In other embodiments, expandable portion 250 can have a different general shape (e.g., spherical, conical, cylindrical, hourglass, etc.). For example, as described in more detail below with respect to FIGS. 11A-15, expandable portion 250 of tip section 124 can be generally "onion" shaped in some embodiments.

[0040] As described in more detail below with respect to Figures 9A-10B, a neck portion 357 of the expandable portion 250 is coupled (e.g., mechanically coupled) to the distal end portion 232 of the shaft 122 via a coupler 367, and a nose portion 355 of the expandable portion is coupled (e.g., mechanically coupled) to the deployment member 235 via a coupler 365 at the distal-most portion 240 of the tip section 124.

[0041] The nose portion 355 of the tip section 124 is configured to at least partially fit within a pulmonary vein of the patient 102 (FIG. 1) and facilitate proper positioning of the modular electrode 352 relative to the cardiac tissue around the ostium of the pulmonary vein. In some embodiments, the modular electrode 352, at least in a fully deployed state (described in more detail below with respect to FIGS. 6A and 6B), has a maximum radial dimension relative to the shaft 122 that is greater than a maximum radial dimension of the ostium of the pulmonary vein of the patient 102 (FIG. 1), preventing insertion of all or a portion of the modular electrode 352 into the pulmonary vein at least in the 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 of 28 mm to 30 mm, i.e., about 29 mm).

[0042] FIG. 4 is a schematic diagram of the tip section 124 without the expandable portion 250 (FIGS. 3A and 3B). In particular, FIG. 4 is primarily a schematic diagram of the deployment member 235. Referring together to FIGS. 3A-4, the deployment member 235, in some embodiments, can be a braided polyimide tube that is coaxial and has a polytetrafluoroethylene (PTFE) inner lining (e.g., for receiving a guidewire 397). In this regard, the deployment member 235 is an elongate member that is flexible enough to be stiff enough to withstand twisting, kinking, or other types of deformation in response to forces required to move, expand, or compress the tip section 124 of the catheter 104 while flexing with movement of the shaft 122. In some embodiments, the braided polyimide tube can additionally or alternatively have a composite PTFE outer lining to allow smooth movement during deployment and compression of the expandable portion 250.

[0043] 4, the deployment member 235 can include one or more ring electrodes 434. For example, the deployment member 235 can include a first ring electrode 434a positioned proximate the distal end portion 232 of the shaft 122 and / or a second ring electrode 434b positioned proximate the distal-most portion 240 of the tip section 124. In some embodiments, the ring electrodes 434a and / or 434b can be formed from platinum-iridium and / or be radiopaque to facilitate fluoroscopic visualization while the tip section 124 is within the patient 102 and aid in determining the location, shape, and / or orientation of the tip section 124 of the catheter 104. Additionally or alternatively, as described in more detail below, ring electrodes 434a and / or 434b can be passive electrodes configured to measure electrical activity, and / or ring electrodes 434a and / or 434b can be driven electrodes that are part of a ground network and / or impedance measurement circuitry.

[0044] FIG. 5 is a top view of the distal-most portion 240 of the tip section 124. Referring together to FIGS. 3A-5, the deployment member 235 can define one or more lumens. For example, the deployment member 235 can define a lumen 349 (FIGS. 3A and 5) that can receive a guidewire 397 (FIGS. 3B and 4) so ​​that the tip section 124 of the catheter 104 can be delivered over the wire to a treatment site. The lumen 349 can be configured to receive various sizes of guidewire 397 (e.g., approximately 0.030 inch to approximately 0.040 inch guidewires, including 0.032 inch, 0.035 inch, and 0.038 inch). In some embodiments, the guidewire 397 can be introduced into the catheter 104 via the electrical connector 248 (FIG. 2) or the fluid connector 249 (FIG. 2) of the handle 120 (FIG. 2). In other embodiments, the catheter 104 and / or deployment member 235 may include a separate guidewire port (not shown) through which a guidewire 397 may be introduced into the catheter 104 and / or deployment member 235.

[0045] In these and other embodiments, the lumen 349 defined by the deployment member 235 and / or another lumen can be in fluid communication with a fluid delivery device, such as the fluid pump 114 (FIG. 1), to deliver fluid (e.g., saline, contrast, etc.) to at least the tip section 124 of the catheter 104. In this regard, the deployment member 235 can be configured to deliver fluid along the length of the shaft 122 and through the tip section 124 to a treatment site (e.g., for irrigation (cooling) of the modular electrodes 352, for flushing (washing) of various components of the tip section 124, and / or for positioning the tip section 124). For example, the deployment member 235 can deliver fluid out of an opening in the lumen 349 in the distal-most portion 240 of the tip section 124. In turn, blood flowing from the lungs of the patient 102 (FIG. 1) through the pulmonary veins toward the left atrium of the patient's heart may carry fluid dispersed from the opening of the lumen 349 across and / or adjacent to the outer portion of the modular electrode 352 that contacts the tissue, thereby facilitating localized heat transfer away from the outer portion of the modular electrode 352. It should be appreciated that such localized heat transfer may generally reduce the likelihood of blood clotting or scorching during tissue treatment.

[0046] In these and other embodiments, the deployment member 235 may include holes (not shown) spaced axially along and / or circumferentially about the deployment member 235 at the tip section 124 to deliver fluid to the treatment site from within the expandable portion 250. In some embodiments, the holes may be cut into the deployment member 235 (e.g., using a laser) and / or formed or molded into the deployment member 235 (e.g., using mechanical drilling). The holes in the deployment member 235 may be uniformly distributed along and / or about the deployment member 235 to facilitate directing fluid toward substantially the entire inner portion of the modular electrode 352 and / or to produce a relatively uniform distribution of fluid along the inner portion of the modular electrode 352. However, it should be understood that the holes in the deployment member 235 may be distributed along and / or about the deployment member 235 in any configuration that facilitates multi-directional distribution of fluid toward the inner portion of the modular electrode 352.

[0047] As used herein, the term "pore" should be understood to include discrete orifices of any size and shape having a maximum dimension through which fluid may flow, and thus, unless otherwise specified or made clear from the context, should be understood to include substantially any geometric shape in any manner and form (e.g., a generally circular shape), and / or, alternatively, a generally irregular shape. The size and number of pores defined by the deployment member 235 are selected such that the pressure of the fluid within the individual lumens of the deployment member 235 is sufficient to prevent blood from entering the pores. For example, subject to some margin of variation in fluid pressure, the size and number of pores defined by the deployment member 235 can be selected such that the pressure of the fluid within the deployment member 235 exceeds the blood pressure of the patient 102 by at least about 0.5 psi.

[0048] The deployment member 235 can be spaced relative to the inner portion of the expandable portion 250 such that the holes direct fluid toward at least the inner portion of the modular electrode 352 in an expanded state (e.g., uncompressed or deployed state). For example, in the deployed state of the modular electrode 352, fluid exits the holes defined by the deployment member 235 and is directed toward the inner portion of the modular electrode 352 while the outer portion of the modular electrode 352 (opposite the inner portion) is in contact with tissue as part of a diagnosis and / or as part of an ablation or other procedure. The spacing between the holes in the deployment member 235 and the inner portion of the modular electrode 352 can facilitate heat transfer between the fluid and the modular electrode 352. Additionally or alternatively, blood can flow through the spacing between the holes in the deployment member 235 and the inner portion of the modular electrode 352. Compared to a configuration in which blood flow away from the treatment site is prevented, blood flow through the gap between the holes in the deployment member 235 and the inner portion of the modular electrode 352 can additionally, or alternatively, further improve local heat transfer away from the outer portion of the modular electrode 352. It should be appreciated that such improved local heat transfer generally can reduce the likelihood of unintentional tissue damage during tissue treatment.

[0049] 4, the deployment member 235 is telescopic (e.g., the deployment member 235 comprises multiple concentric tube components) such that the distal-most portion 240 of the tip section 124 can be expanded and / or retracted (e.g., contracted) relative to the distal end portion 232 of the shaft 122. The telescopic feature of the deployment member 235 facilitates the deployment and compression of the expandable portion 250 of the tip section 124. For example, the deployment member 235 is mechanically coupled to the expandable portion 250 via a coupler 365 at the distal-most portion 240 of the tip section 124 such that axial movement of the deployment member 235 relative to the shaft 122 can impart a compressive and / or expansion force on the expandable portion 250.

[0050] 6A and 6B are schematic illustrations of the expandable portion 250 in a compressed state and a deployed state, respectively. Starting with the expandable portion 250 in a compressed state (FIG. 6A), proximal movement of the deployment member 235 (retraction / contraction of the telescopic feature) can pull the distal end of the expandable portion 250 in a proximal direction relative to the shaft 122 such that the expandable portion 250 expands to a non-compressed or deployed state (FIG. 6B). The deployed state of the expandable portion 250 can be used for treatment, diagnosis, or both of tissue at the treatment site. Additionally or alternatively, distal movement of the deployment member 235 (expansion of the telescopic feature) can push the distal end of the expandable portion 250 in a distal direction relative to the shaft 122 such that the expandable portion 250 collapses from the deployed state (FIG. 6B) to the compressed state (FIG. 6A). The compressed state of the expandable portion 250 can be used for retraction, delivery, or both of the tip section 124 at the treatment site. In some implementations, the deployment member 235 can be mechanically coupled to a portion of the handle 120 (eg, the actuation portion 246 shown in FIG. 2) such that movement of the deployment member 235 can be controlled at the handle 120.

[0051] In some embodiments, an interior portion of the modular electrodes 352 along the expandable portion 250 can be closer to a compressed state than to an uncompressed state relative to at least a portion of a surface of the deployment member 235, and thus the interior portion of the modular electrodes 352 can move away from at least a portion of a surface of the deployment member 235 as the expandable portion 250 is expanded from a compressed state (FIG. 6A) to an uncompressed state (FIG. 6B). It should be understood that various degrees of compression and expansion of the expandable portion 250 can be achieved through various degrees of proximal and distal movement, respectively, of the deployment member 235. For example, the expandable portion 250 can be (i) further compressed than that illustrated in Figure 6A via additional distal movement (expansion) of the deployment member 235, (ii) further expanded than that illustrated in Figure 6B via additional proximal movement (retraction) of the deployment member 235, and / or (iii) uncompressed or compressed to one or more states between the states illustrated in Figures 6A and 6B via axial movement of the deployment member 235 that positions the distal-most portion 240 of the tip section 124 between the positions of the distal-most portion 240 of the tip section 124 illustrated in Figures 6A and 6B. In some embodiments, the expandable portion 250 can be expanded until the nose portion 355, the distal portion of the actuating body portion 352, or both, form a distal surface that is approximately normal to the deployment member 235 and can be positioned relatively flat against tissue (e.g., around the ostium of a pulmonary vein).

[0052] The expandable portion 250 (FIGS. 3A and 3B) is a discontinuous structure made up of multiple mesh electrode panels. FIGS. 7A and 7B are schematic illustrations of individual mesh electrode panels 750 that may, for example, be combined with other panels 750 to form the expandable portion 250. For example, as shown in FIGS. 7A and 7B, each mesh electrode panel 750 includes multiple struts 751, 755, and 757. All or a portion of the struts 751 form an active portion 752 of the panel 750 through which energy can be delivered to tissue. As shown, the active portion 752 of the panel 750 is much wider than the portion of the panel 750 formed by struts 757 and 755. In contrast, all or a portion of the struts 757 of each mesh electrode panel 750 are insulated such that electrical energy cannot be delivered to tissue through the insulated portions of the struts 757. In the illustrated embodiment, all or a portion of the struts 755 of each mesh electrode panel 750 are also insulated such that electrical energy cannot be delivered to tissue through the insulated portions of the struts 755. Additionally or alternatively, all or a portion of the struts 755 can form part of the active portion 752 of the panel 750 through which energy can be delivered to tissue. In some embodiments, the struts 755 and / or 757 can be insulated using a PTFE sleeve or other polymer (e.g., polyimide and / or Pebax®). However, in other embodiments, the struts 755 and / or 757 may be insulated using an adhesive or other suitable material.

[0053] The panels 750 can be formed (e.g., laser cut, 3D printed, chemically etched, etc.) from a sheet or tube of material that is reproducibly and reliably flexible between compressed and uncompressed states. In some embodiments, the material can be at least (e.g., semi- or fully) radiopaque to facilitate visualization of the material while within the patient 102. One example of a material that meets either or both of the above criteria is Nitinol. After forming each mesh electrode panel 750 from the material, one or more surfaces of the panel 750 can be electropolished. Such electropolishing can be useful, for example, to smooth the surface and / or otherwise produce fine adjustments to the amount of material used to form each panel 750. Additionally or alternatively, the material for forming each mesh electrode panel 750 can be coated with one or more of gold, tantalum, iridium oxide, or other materials. Thus, following the above example, all or a portion of the active portion 752 of the mesh electrode panel 750 can optionally be coated to deliver electrical energy to tissue.

[0054] The struts 751 of each mesh electrode panel 750 can be mechanically coupled to one another and collectively define a plurality of cells 753. Thus, each cell 753 can be bounded by at least three struts 751 (e.g., by at least four struts 751). Additionally, or alternatively, each strut 751 can define a portion of at least one of the cells 753. In some embodiments, the cells 753 can be bounded by different numbers of struts 751, which can facilitate achieving a targeted distribution of current density along the expandable portion 250 (FIGS. 2-3B) when the panels 750 are mechanically coupled to one another, as described in more detail below with respect to FIGS. 8A-8D.

[0055] Also, or instead, at least some of the struts 751 can be (a) coupled to struts 757 and transition between a portion of the panel 750 corresponding to the modular electrodes 352 of the expandable portion 250 and a portion of the panel 750 corresponding to the neck portion 357 of the expandable portion 250, and (b) coupled to struts 755 and transition between a portion of the panel 750 corresponding to the modular electrodes 352 of the expandable portion 250 and a portion of the panel 750 corresponding to the nose portion 355 of the expandable portion 250. For example, an electrode panel 750 configured in accordance with various embodiments of the present technology can include at least one strut 757 (e.g., a single strut 757) and form at least a portion of the neck portion 357 of the expandable portion 250. A proximal end (e.g., most proximal) portion of the strut 757 can be mechanically coupled to the distal end portion 232 of the shaft 122. A proximal end (e.g., most proximal) portion of the first strut 751 can be coupled to the strut 757 (e.g., a distal end portion and / or a distal-most portion of the strut 757), and a proximal end (e.g., most proximal) portion of the second strut 751 can be coupled to the strut 757 (e.g., a distal end portion and / or a distal-most portion of the strut 757). Thus, in some embodiments, the strut 757 and the first and second struts 751 of the electrode panel 750 can form a “Y” shape at the transition between the portion of the panel 750 corresponding to the neck portion 357 of the expandable portion 250 and the portion of the panel 750 corresponding to the modular electrodes 352 of the expandable portion 250.

[0056] Additionally or alternatively, an electrode panel 750 configured according to various embodiments of the present technology can include at least one strut 755 (e.g., a single strut 755) forming at least a portion of a nose portion 355 of an expandable portion 250 (and / or at least a portion of a modular electrode 352, as discussed in more detail below with respect to FIGS. 11A-14C). A distal end (e.g., most distal) portion of the strut 755 can be mechanically coupled to a distal-most portion 240 of the tip section 124. A distal end (e.g., most distal) portion of a first strut 751 can be coupled to the strut 755 (e.g., a proximal end portion and / or a proximal-most portion of the strut 755), and a distal end (e.g., most proximal) portion of a second strut 751 can be coupled to the strut 755 (e.g., a proximal end portion and / or a proximal-most portion of the strut 755). Thus, in some embodiments, the struts 755 and the first and second struts 751 of the electrode panel 750 can form a “human” shape at or near the transition between the portion of the panel 750 corresponding to the nose portion 355 (and / or modular electrode 352) of the expandable portion 250 and the portion of the panel 750 corresponding to the modular electrode 352 of the expandable portion 250.

[0057] In these and other embodiments, at least some of the cells 753 of the panel 750 are symmetrical. Such symmetry can facilitate, for example, achieving a targeted distribution of current density along the modular electrodes 352. Additionally, or alternatively, such symmetry can be useful for achieving suitable compressibility of the expandable portion 250 for delivery to the treatment site, while also achieving suitable expansion of the expandable portion 250 for use at the treatment site.

[0058] In some embodiments, at least some of the cells 753 can have mirror symmetry. As used herein, a mirror symmetric shape includes a shape that is generally symmetric about a plane that intersects the shape, with substantial symmetry allowing for the presence or absence of pores 758 on one or both sides of the plane that intersects the shape. For example, at least some of the cells 753 can have mirror symmetry about a respective mirror symmetry plane that passes through the respective cells 753 and contains a central axis that is defined by the shaft 122 (FIGS. 1 and 2) and extends from the proximal end portion to the distal end portion of the shaft 122. Additionally or alternatively, it should be understood that the entire expandable portion 250 (FIGS. 3A and 3B) of the tip section 124 can be symmetric about one or more planes that include the central axis. The symmetry of the expandable portion 250 can, for example, facilitate symmetric delivery of energy to tissue at various locations around the expandable portion 250.

[0059] Mirror symmetry of at least some of the cells of the plurality of cells 753 and / or the entire expandable portion 250 can be useful, for example, to achieve a targeted distribution of current density. Additionally or alternatively, symmetry can facilitate expansion and contraction of the expandable portion 250 in a predictable and reproducible manner (e.g., with little or no plastic deformation). For example, each of the cells of the plurality of cells 753 can be symmetric about its respective plane of symmetry in the compressed and uncompressed states of the expandable portion 250.

[0060] At least some of the plurality of cells 753 can be axially and laterally flexible such that an open framework formed by the plurality of cells 753 along the expandable portion 250 is similarly flexible when the plurality of panels 750 are mechanically coupled together, as described in more detail below. For example, at least some of the plurality of cells can be generally diamond shaped in the uncompressed state of the expandable portion 250. As used herein, generally diamond shaped includes a shape having a first pair of seams substantially aligned along a first axis and a second pair of seams substantially aligned along a second axis different from the first axis (e.g., perpendicular to the first axis).

[0061] 7A and 7B, the length of the struts 751 decreases in a direction from a proximal region of the panel 750 (near strut 757) to a distal region of the panel 750 (near strut 755), which contributes to a general "pear" shape of the expandable portion 250 when multiple panels 750 are mechanically coupled to one another. However, in other embodiments, the length of the struts 751 can be uniform, increasing, or non-monotonic varying across the mesh electrode panel 750 in the same or similar direction (from the proximal region of the panel 750 to the distal region of the panel 750), for example, contributing to another general shape of the expandable portion 250 (e.g., an "onion" shape). Additionally or alternatively, a bottom section of the panel 750, which includes a subset of the struts 751 that correspond to the modular electrodes 352 of the expandable portion 250, can be wider than an upper section of the panel 750, which includes a different subset of the struts 751 that correspond to the modular electrodes 352 of the expandable portion 250 (e.g., to contribute to the general shape of the expandable portion 750 when multiple panels 750 are mechanically coupled to one another).

[0062] In these and other embodiments, the width 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). The different widths of the struts 751, 755, and / or 757 can help provide a desired stiffness at a given location on the panel 750. For example, the width of the struts 755 and / or 757 can be greater than the width of the struts 751 such that the active portion 352 of the panel 750 formed by the strut 751 is more flexible than the struts 755 and / or 757. Continuing with this example, as the multiple panels 750 are mechanically coupled to one another (as described in more detail below), the modular electrodes 352 of the expandable portion 250, formed from the active portions 352 of the panels 750, can be more flexible (e.g., more conformable) than the neck portions 357 formed from the struts 757 and / or the nose portions 355 formed from the struts 755. In these and other embodiments, the nose portions 355 formed from the struts 755 can be more flexible than the neck portions 357 formed from the struts 757, allowing the nose portions 355 to expand more relative to the deployment member 235 than the neck portions 357 as the expandable portion 250 is deployed (e.g., expanded). In some embodiments, the width of the struts 757 can vary. For example, strut 757 can include a first portion having a first width and a second portion having a second width that is 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 struts 755 and / or 757 can exceed the length of strut 751.

[0063] 7A and 7B, material removed from the sheet or tube of material can define keyed portions 794 at the ends of posts 755 and 757. As discussed in more detail below, keyed portions 794 of posts 755 and 757 facilitate connecting panel 750 to deployment member 235 and distal end portion 232 of shaft 122, respectively.

[0064] Additionally or alternatively, material removed from the sheet or tube of material can define perforations 758 disposed at one end of at least some of the struts 751. Perforations 758 can be defined, for example, at the intersections of two or more of the struts 751 and can be used to interconnect (e.g., mechanically couple) multiple mesh electrode panels 750. Each of the panels 750 illustrated in FIGS. 7A and 7B includes four perforations 758, with two of the perforations 758 positioned on either side of an axis extending from strut 757 to strut 755. However, in other embodiments, the panel 750 can include a fewer (e.g., one, two, or three) or greater (e.g., five or more) total number of perforations and / or a fewer (e.g., zero or one) or greater (e.g., three or more) number of perforations positioned on either side of an axis extending from strut 757 to strut 755. In these and other embodiments, the panel 750 can include eyelets 758 in other locations than those depicted in the embodiment shown in Figures 7A and 7B. For example, at least one of the eyelets 758 can be positioned between the ends of one of the posts 751.

[0065] 8A-8D diagrammatically illustrate how mesh electrode panels 750 are attached to form the expandable portion 250 of the tip section 124. As shown in FIGS. 8A-8C, the eyelets 758 of adjacent mesh electrode panels 750 are aligned (overlapping) and held together with fasteners 870. In the illustrated embodiment, the fasteners 870 are rivets having primary heads 871. In such implementations, the eyelets 758 of adjacent mesh electrode panels 750 can be aligned with one another, for example, such that the primary heads 871 of the fasteners 870 pass through the aligned eyelets 758. The primary heads 871 are hollow (at least partially) such that a bottom portion 871a of the primary heads 871 can be splayed outward to hold the fasteners 870 within the eyelets 758 and hold the panels 750 together through the force exerted by the fasteners 870 on the corresponding eyelets 758. In other embodiments, different types of fasteners 870 (e.g., double headed rivets, crimps, flange screws and washers, PEM® fasteners, etc.) can be used. In some embodiments, the fasteners 870 can be formed from a different material (e.g., a polymer such as polyetheretherketone (PEEK)) than the material used to form the mesh electrode panel 750. As described in more detail below, the primary heads 871 of at least some of the fasteners 870 can house and / or include a sensor 826, which can be in electrical communication with the interface unit 108 ( FIG. 1 ) and / or the generator 115 ( FIG. 1 ) via one or more electrical leads 806 that extend the length of the shaft 122 ( FIGS. 1 and 2 ) and / or the handle 120 ( FIGS. 1 and 2 ).

[0066] A polymer disk 872 formed from an electrically insulating material (e.g., any of a variety of different biocompatible polymers, such as polyimide) is used to separate and electrically insulate adjacent mesh electrode panels 750 from each other and / or from the sensors 826 contained within the fasteners 870. In the illustrated embodiment, the polymer disks 872 are shown as separate disks. In other embodiments, one or more of the polymer disks 872 can form a single integrated piece of insulation. In these and other embodiments, a portion of the electrical lead 806 (e.g., a flexible printed circuit) can electrically insulate adjacent mesh electrode panels 750 from each other and / or from the sensors 826 contained within the fasteners. In some embodiments, a portion of the electrical lead 806 can replace the polymer disk 872 (e.g., the top polymer disk 872 shown illustrated between the primary head 871 of the fastener 870 and the eyelet 758 of the top panel 750 in FIG. 8A).

[0067] Additionally or alternatively, an eyelet 873 can be disposed within the orifice of the aligned stoma 758 between the sensor 826 and the panel 750. The eyelet 873 can be formed, for example, from an electrically insulating material (e.g., any of a variety of different biocompatible polymers). In this manner, the eyelet 873 can electrically insulate the sensor 826 from the mesh electrode panel 750. Additionally or alternatively, the eyelet 873 can be formed from a flexible material, for example, to facilitate an interference fit of the eyelet 873 and the sensor 826 through the orifice. In some embodiments, the eyelet 873 can include a bottom portion (not shown) that can be flared outward (e.g., to hold the eyelet 873 in place, provide electrical insulation, etc.). Additionally or alternatively, the eyelet 873 can include a bottom flange portion (not shown). In some embodiments, the bottom flange portion can replace a portion of the polymer disk 872 (e.g., the bottom most polymer disk 872, the polymer disk 872 shown between the perforations 758 in FIG. 8A, etc.) or the polymer disk 872 / insulation strip. In general, the eyelet 873 can reduce the likelihood that mounting the sensor 826 within the orifice would interfere with the operation of the sensor 826. For example, the eyelet 873 can facilitate mounting the sensor 826 to the panel 750 of the expandable portion 250 without requiring physical modification (e.g., drilling) of the sensor 826.

[0068] An encapsulating material 874 can be formed over the fastener 870 and / or the back side of the sensor 826 (e.g., to electrically insulate the portions of the sensor 826 that are not in contact with tissue, to electrically insulate the sensor 826 from the panel 750, and / or to electrically insulate individual panels 750 from each other). In some embodiments, the encapsulating material 874 can be an adhesive that is cured in place. In other embodiments, the encapsulating material 874 can be a reflow thermoplastic or another insulator.

[0069] In some embodiments, at least one of the fasteners 870 does not house or include a sensor 826. Such fasteners 870 can be formed from a different material (e.g., a polymer such as PEEK) than the material used to form the mesh electrode panel 750. In these embodiments, one or more of the polymer disks 872 (e.g., except for the polymer disks 872 positioned between the perforations 758 of adjacent electrode panels 750 and used to electrically insulate the panels 750 from one another), eyelets, and / or encapsulating material 874 can be omitted from the fasteners 870 that do not include a sensor 826.

[0070] 14A-14C, one or more of the struts 751 of at least one panel 750 may, in some embodiments, include one or more features (e.g., one or more bends) proximate one or more of the corresponding eyelets 758. Such features can facilitate recessing the corresponding sensor 826 relative to the exterior of the expandable portion 250 when the corresponding panels 750 are attached to one another. This can be advantageous, for example, in allowing the expandable portion 250 to smoothly pass in and out of the introducer sheath (e.g., without the corresponding sensor 826 getting caught on an edge of the introducer sheath at one or more openings in the sheath).

[0071] Although the panel 750 is illustrated in Figures 7A-8D as having one or more eyelets 758 that facilitate mechanically coupling the panels 750 to one another, the panel 750 and / or the expandable portion 250 in other embodiments can include other attachment means in addition to or in place of the eyelets 758 for mechanically coupling the panels 750 to one another. For example, an exterior joint of one or more of the cells 753 along the perimeter of a panel 750 can be mechanically coupled to a corresponding exterior joint of one or more of the cells 753 along the perimeter of another panel 750 using fasteners (e.g., using the non-conductive fasteners of Figure 8 that pass through the cells 753 on the respective perimeter of the panel 750, using non-conductive fasteners that pass through one or more of the cells 753 on the respective perimeter of the panel 750 and go back and forth between the panels 750 from the posts 755 to the posts 757 (and / or vice versa), etc.). Independent of the method by which the panels 750 are bonded to one another, in some embodiments, an insulating material (e.g., eyelets, sleeves, adhesive, dip cast, heat shrink, reflow thermoplastic, or another suitable material) may be applied to the posts 751 and / or perforations 758 to provide additional electrical insulation between adjacent mesh electrode panels 750.

[0072] 8D , as multiple (e.g., 2, 3, 4, 5, 6, or more (e.g., 7-12)) mesh electrode panels 750 are mechanically coupled to one another, the panels 750 collectively form a closed shape and define the expandable portion 250. In the illustrated embodiment, six mesh electrode panels 750 form the pear-shaped expandable portion 250. In particular, all or a portion of the struts 751 of the panels 750 form the modular electrodes 352 of the expandable portion 250. In addition, the struts 755 of the panels 750 form the nose portion 355 of the expandable portion 250, and the struts 757 of the panels 750 form the neck portion 357 of the expandable portion 250, as described in more detail below.

[0073] As shown, a central section of the expandable portion 250 corresponding to the modular electrode 352 is much wider than a first section corresponding to a neck portion 357 of the expandable portion 250 and / or a second section corresponding to a nose portion 355 of the expandable portion 250 (and / or a portion of the modular electrode 352, as discussed in more detail below with respect to FIGS. 11A-14C ). Additionally or alternatively, the expandable portion 250 includes a greater number of cells 753 around the equator of the expandable portion 250 than around the first section and / or the second section.

[0074] As shown, a plurality of cells 753 of expandable portion 250 are bounded by at least four struts (e.g., by strut 751, strut 757, and / or strut 755). Some of the cells 753 are each bounded by struts (e.g., by strut 751, strut 757, and / or strut 755) belonging to a different (e.g., adjacent) electrode panel 750. For example, a cell 753 of expandable portion 250 in nose portion 355 is bounded by strut 755 and at least one strut 751 of a first panel 750 and by strut 755 and at least one strut 751 of a second (e.g., adjacent) panel 750. Similarly, the cells 753 of the expandable portion 250 in the neck portion 357 are bounded by the struts 757 and at least one strut 751 of the first panel 750 and by the struts 757 and at least one strut 751 of the second (e.g., adjacent) panel 750. As yet another example, the cells 753 of the expandable portion 250 in the modular electrode 352 are bounded by at least one strut 751 of the first panel 750 and by at least one strut 751 of the second (e.g., adjacent) panel 750.

[0075] In the uncompressed state, the struts 751, the pores 758 (shown filled with fasteners 870 in FIG. 8D ), and the cells 753 formed by the struts 751 together form an open framework having a conductive surface along at least a portion of the modular electrode 352 of the expandable portion 250. For example, the open framework formed by the struts 751, the pores 758, and the cells 753 can have an open area of ​​greater than about 50 percent along an outer portion of the modular electrode 352 when the expandable portion 250 is in an uncompressed state. Continuing with this example, in the uncompressed state, the combined open area of ​​the cells 753 can exceed the combined area of ​​the struts 751 and the pores 758 along the outer portion of the modular electrode 352. Additionally or alternatively, at least some of the cells 753 can have a larger area in the uncompressed state of the expandable portion 250 than in the compressed state of the expandable portion 250.

[0076] As discussed above, the expandable portion 250 can be expanded (e.g., deployed) and compressed via proximal and axial movement of the deployment member 235, respectively. To facilitate the transition of the expandable portion 250 from a compressed state to a deployed state (or vice versa), the respective struts 751 of the panel 750 can be flexible relative to one another. For example, the maximum radial dimension (alternatively referred to herein as the lateral dimension) of the modular electrodes 352 can increase by at least a factor of two as the coupled struts 751 move relative to one another to transition the expandable portion 250 from a fully compressed state to a fully uncompressed state in the absence of an external force. Additionally or alternatively, the struts 751 can be movable relative to one another such that the maximum radial dimension of the expandable portion 250 in an uncompressed state is at least about 20 percent greater than the maximum radial dimension of the shaft 122 (e.g., greater than the maximum radial dimension of the distal end portion 232 of the shaft 122). For example, expandable portion 250 in an uncompressed state, as illustrated in FIGURE 8D, has an outer diameter of greater than about 20 mm and less than about 40 mm (e.g., a diameter of 28 mm to 30 mm, or about 29 mm), while shaft 122 has an outer diameter of greater than about 1.5 mm and less than about 7 mm (e.g., a diameter of 2 mm to 3.5 mm, or about 2.7 mm). This ratio of size increase is achieved through the use of an open framework of cells 753 formed by struts 751, which uses less material than would otherwise be required for a solid shape of the same size.

[0077] In some embodiments, the expandable portion 250 can assume its expanded (e.g., pear) shape in the absence of external forces. For example, when the expandable portion 250 is not mechanically coupled (e.g., untethered) to the distal-most portion 240 of the tip section 124, the distal end portion 232 of the shaft 122, and / or another portion of the catheter, and / or when no other compressive forces are acting on the expandable portion 250, the expandable portion 250 can assume its deployed shape. In some embodiments, the expanded or deployed shape can have a diameter that is greater than the maximum diameter of the catheter shaft 122.

[0078] It should be appreciated that the open area of ​​the expandable portion 250 may facilitate the flow of fluid and blood therethrough during treatment. In other words, the inner portion of the modular electrode 352 may be in fluid communication with the outer portion of the modular electrode 352 through the plurality of cells 753 such that, in use, fluid, blood, or a combination thereof may travel through the plurality of cells 753 and cool the modular electrode 352 and tissue in the vicinity of the modular electrode 352. Compared to electrodes that impede blood flow, the open area of ​​the expandable portion 250 may reduce the likelihood of localized heating of blood at the treatment site as energy is delivered to tissue. Furthermore, compared to electrodes that impede blood flow, the open area of ​​the expansion portion 250 may reduce the likelihood of blood clotting or clot formation, thereby reducing the likelihood of thromboembolism. It should also be appreciated that delivery of fluid to the inner portion of the modular electrode 352 may increase the cooling that occurs through the flow of blood alone through the open area.

[0079] As discussed above, the struts 755 of the panel 750 together form the nose portion 355 of the expandable portion 250, and the struts 757 of the panel 750 together form the neck portion 357 of the expandable portion 250. Figures 9A-10B illustrate how the mesh electrode panel 750 of the expandable portion 250 is attached to the deployment member 235 (shown in Figures 9A and 9B) and the distal end portion 232 of the shaft 122 (shown in Figures 10A and 10B).

[0080] 9A and 9B, a coupler 365 at the distal-most portion 240 of the tip section 124 couples the post 755 to the deployment member 235 (FIG. 9A). In some embodiments, the coupler 367 is a machined hard insulator, such as a PEEK coupler. In the illustrated embodiment, the coupler 365 includes a first portion 965a and a second portion 965b. The first portion 965a includes a recessed portion configured to receive a corresponding key portion 794 of the post 755. The recessed portion of the first portion 965a of the coupler 365 prevents axial movement (within machining tolerances) of the key portion 794 of the post 755 relative to the distal-most portion 240 of the tip section 124. The second portion 965b of the coupler 365 fits over the first portion 965a and retains the key portion 794 of the post 755 within the recessed portion of the first portion 965a.

[0081] In other embodiments, the post 755 can be coupled to the distal-most portion 240 of the tip section 124 using other types of couplers 365. For example, both ends of the post 755 can include apertures configured to receive the alignment pin or rivet of the coupler 365. The coupler 365 in these embodiments can include a corresponding second portion configured to receive and retain the alignment pin or rivet, aligning the ends of the post 755 to the second portion, and holding the ends of the post 755 in place. Still other examples of couplers 365 within the scope of the present technology include heat staking, crimping, ultrasonic welding, or reflowing to hold the ends of the post 755 in place.

[0082] As discussed above, in the illustrated embodiment, all or a portion of the posts 755 are insulated. As best shown in FIG. 9A , the posts 755 include an insulator 993 (e.g., a polyethylene terephthalate (PET) or PTFE sleeve) that covers a majority of the posts 755. In some embodiments, the insulator 993 terminates before the key portion 794 of the posts 755. In other embodiments, the insulator 993 extends to and / or coats all or a portion of the key portion 794. Additionally or alternatively, the coupler 365 may include an insulating material to prevent electrical connection between the mesh electrode panels 750.

[0083] 10A and 10B, a coupler 367 couples the posts 757 of the mesh electrode panel 750 to the distal end portion 232 of the shaft 122. In some embodiments, the coupler 367 is a machined hard insulator, such as a PEEK coupler.

[0084] In the illustrated embodiment, the coupler 367 includes a first portion 1067a (FIG. 10A) and a second portion 1067b (FIG. 10B). The first portion 1067a includes a recessed portion configured to receive a corresponding key portion 794 of the post 757. The recessed portion of the first portion 1067a of the coupler 367 prevents axial movement (within machining tolerances) of the key portion 794 of the post 755 relative to the distal end portion of the shaft 122. The second portion 1067b of the coupler 367 fits over the first portion 1067a and retains the key portion 794 of the post 757 within the recessed portion of the first portion 1067a.

[0085] In other embodiments, the post 757 can be coupled to the distal end portion 232 of the shaft 122 using other types of couplers 367. For example, both ends of the post 757 can include apertures configured to receive the alignment pin or rivet of the coupler 367. The coupler 367 in these embodiments can include a corresponding second portion configured to receive and retain the alignment pin or rivet, aligning the ends of the post 757 to the second portion, and holding the ends of the post 757 in place. Still other examples of couplers 367 within the scope of the present technology include heat staking, crimping, ultrasonic welding, or reflowing to hold the ends of the post 757 in place.

[0086] As discussed above, all or a portion of the posts 757 are insulated. As best shown in FIG. 10A , the posts 757 include an insulator 1093 (e.g., a PTFE sleeve) that covers a majority of the posts 757. In some embodiments, the insulator 1093 terminates before the key portion 794 of the posts 757. In other embodiments, the insulator 1093 extends to and / or coats all or a portion of the key portion 794. Additionally or alternatively, at least a portion of the coupler 367 may include an insulating material to prevent electrical connection between the mesh electrode panels 750.

[0087] The coupling 367 can include electrical contacts that are electrically coupled to the generator 115 ( FIG. 1 ) via one or more of the electrical leads or wires 148 ( FIG. 1 ) and / or other conductive paths that extend from the generator 115 down the length of the shaft 122. In these and other embodiments, when the posts 757 are secured within the coupling 367, the posts 757 can each be electrically coupled directly or indirectly to the generator 115 ( FIG. 1 ) via one or more of the electrical contacts of the coupling 367 and / or via one or more of the electrical leads or wires 148 and / or other conductive paths that extend from the generator 115 down the length of the shaft 122. In this manner, as described in more detail below, electrical energy provided by the generator 115 can be delivered separately to the posts 751 of the individual mesh electrode panels 750 of the expandable portion 250 via the posts 757 of the panel 750, and the electrical energy can be delivered to the tissue of the patient 102 via corresponding sections of the modular electrode 352.

[0088] 8A-8D , sensors 826 can be mounted along the modular electrodes 352 of the expandable portion 250 at all or a subset of the locations where adjacent mesh electrode panels 750 are mechanically coupled to one another by eyelets 758 and fasteners 870. In general, the sensors 826 can be positioned along one or both of the inner and outer portions of the modular electrodes 352.

[0089] Each sensor 826 can be electrically insulated from the panel 750 and mounted on and / or in the fastener 870. For example, each sensor 826 can be mounted to the fastener 870 using a flexible adhesive (e.g., epoxy or room temperature vulcanizing (RTV) silicone), any of a variety of different mechanical retention features (e.g., tabs) between the sensor 826 and the fastener, and / or molding or overmolding the sensor 826 onto the fastener 870. Additionally or alternatively, the sensor 826 can extend through a portion of the fastener 870 and / or through an eyelet 758 in the panel 750. Such positioning of the sensor 826 through a portion of the fastener 870 can facilitate forming a robust mechanical connection between the sensor 826 and the fastener 870. Additionally or alternatively, positioning of the sensor 826 through a portion of the fastener can facilitate measuring conditions along outer and inner portions of the modular electrode 352.

[0090] An electrical lead 806 extends from each sensor 826 within or along the expandable portion 250 and into the shaft 122 (FIG. 2). The electrical lead 806 may comprise a wire (e.g., an insulated wire) or a printed circuit (e.g., a flexible printed circuit) or a combination thereof. The electrical lead 806 is in electrical communication with the interface unit 108 (FIG. 1) and / or the generator 115 (FIG. 1) such that each sensor 826 may send electrical signals to and receive electrical signals (e.g., electrical energy) from the interface unit 108 and / or the generator 115 during use. As discussed in more detail below with respect to FIG. 13, one or more additional sensors (not shown in FIGS. 1-10B) can be formed by and / or positioned on one or more of the electrical leads 806 such that when the expandable portion 250 contacts tissue, the one or more additional sensors remain within the interior of the expandable portion 250 and do not contact tissue.

[0091] The sensors 826 can be substantially uniformly spaced from one another (e.g., circumferentially and / or axially) along the modular electrodes 352 of the expandable portion 250 when the expandable portion 250 is in an uncompressed state. Such a substantially uniform distribution of the sensors 826 can facilitate, for example, determining the shape (e.g., degree of expansion and / or deformation) and / or temperature profile of all or a portion of the modular electrodes 352 during use. For example, the sensors 826 can be electrically isolated from the modular electrodes 352, such that the sensors 826 (acting as surface electrodes) passively detect electrical activity of tissue proximate to each individual sensor 826 without interference from the modular electrodes 352. At least some of the sensors 826 can be disposed at least partially along an outer portion of the expandable portion 250 with the expandable portion 250 being between one or more internal electrodes (e.g., ring electrode 434a, ring electrode 434b, and / or one or more additional sensors formed by and / or positioned on one or more of the electrical leads 806) and at least a portion of each individual one of the sensors 826 along the outer portion. Additionally or alternatively, at least some of the sensors 826 can extend through the modular electrodes 352. In these embodiments, one or more of the sensors 826 can be insulated along an inner portion of the expandable portion 250 and / or exposed along an outer portion of the expandable portion 250. Also, or alternatively, at least some of the sensors 826 can be disposed at least partially along an inner portion of the expandable portion 250 and / or exposed. In such implementations, each sensor 826 can be in close proximity to the tissue without touching the tissue when the modular electrodes 352 touch the tissue.

[0092] Each sensor 826 can act as an electrode (e.g., a surface electrode) to detect cardiac electrical activity in an area local to the sensor 826. In some embodiments, one or more of the sensors 826 can be coated with platinum black or iridium oxide (e.g., to reduce impedance or noise). Additionally or alternatively, each sensor 826 can include a temperature measuring device (e.g., a thermocouple or thermistor). For example, the sensor 826 can include a flexible printed circuit, a temperature measuring device affixed between a portion of the flexible printed circuit, and a termination pad opposite the temperature measuring device. Continuing with this example, the sensor 826 can be mounted on the fastener 870 with the thermistor disposed along an outer portion of the expandable portion 250 and the termination pad disposed along an inner portion of the expandable portion 250. In some instances, the thermistor can be disposed along the outer portion to provide an accurate indication of tissue temperature. A thermally conductive adhesive or other conductive material may be placed over the thermistor to affix the thermistor to the flexible printed circuit. In these and other embodiments, one or more of the sensors 826 may include an ultrasonic transducer, an optical fiber, and / or another type of image sensor. As another example, the sensor 826 may include a flexible printed circuit with two or more electrodes, one of which is disposed along an outer portion of the expandable portion 250. As yet another example, the sensor 826 may include a thermocouple formed at the junction of two metals within the sensor 826 (e.g., within a flexible printed circuit, e.g., comprising a constantan trace and a copper trace) or in the electrical connection between the sensor 826 and the electrical lead 826.

[0093] In some implementations, each sensor 826 can be formed from and / or include a radiopaque material. The radiopacity of the sensor 826 can, for example, facilitate visualization of the sensor 826 during use (e.g., using fluoroscopy). Examples of radiopaque materials that can form and / or be added to the sensor 826 include platinum, platinum iridium, gold, radiopaque inks, and combinations thereof. The radiopaque material can be formed and / or added in any pattern, such as, for example, dots and / or rings, that can facilitate visualization of the radiopaque material.

[0094] In certain implementations, each sensor 826 can form part of an electrode set useful for detecting contact between each sensor 826 and tissue. For example, electrical energy (e.g., current) can be driven through each sensor 826 and another electrode or electrodes (e.g., any one or more of the various different electrodes described herein), and a change in the measured signal (e.g., voltage or impedance) can indicate the presence of tissue. Because the position of the tip section 124 is known, detection of contact through the individual measured signals at the sensors 826 can be useful for determining the shape of the anatomical structure in which the tip section 124 is positioned and / or tissue engagement / contact with the tip section 124 during the course of a medical procedure. Additionally or alternatively, the signals measured at the sensors 826 can be useful for determining the position of the introducer sheath relative to the tip section 124, for example, by detecting an increase in the measured signal (e.g., voltage or impedance) when the sensor is covered by a sheath, thereby indicating that the sheath is at least partially covering the tip section 124.

[0095] In use, each sensor 826 may additionally or alternatively act as an electrode to detect electrical activity in an area of ​​the heart local to the respective sensor 826, the detected electrical activity forming the basis for an electrogram associated with the respective sensor 826 and additionally or alternatively providing lesion feedback or other feedback. The sensors 826 may be arranged such that the electrical activity detected by each sensor 826 may form the basis of a unipolar electrogram and / or a bipolar electrogram. For example, in embodiments in which one or more additional sensors are formed by and / or positioned on one or more electrical leads 806, the sensor 826 may cooperate with the additional sensor to form one or more bipolar electrograms. Additionally or alternatively, in embodiments in which 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 can cooperate with a central electrode (e.g., ring electrodes 434a and / or 434b (FIG. 4) on the deployment member 235) to provide a near-unipolar electrogram, as described in more detail below. For example, electrical activity detected (e.g., passively detected) by the central electrode and the sensor 826 (acting as a surface electrode) can form the basis of an individual electrogram associated with each unique pair of central electrode and sensor 826. As a more specific example, in an implementation in which there are six sensors 826, the central electrode forms six electrode pairs with the sensor 826, which in turn can form the basis for six individual electrograms. An electrogram formed by the electrical signals received from each individual electrode pair (e.g., an individual one of the central electrode and sensor 826) can be generated through any of a variety of different methods.In general, the electrogram associated with an individual electrode pair may be based on the difference between the signals from the electrodes in the pair, and therefore, more specifically, may be based on the difference between the electrical signal received from the central electrode and the individual one of the sensors 826. The electrogram may be filtered or otherwise further processed, for example, to reduce noise and / or highlight the electrical activity of the heart. It should be understood that the sensor 826 and the central electrode may cooperate to provide a near-unipolar electrogram in addition to or as an alternative to any one or more of a variety of different methods of determining contact, shape, force, and impedance described herein, each of which may include additional or alternative cooperation between the sensor 826 and the central electrode.

[0096] The multiple sensors 826 can be used to detect deformation of the expandable portion 250 (e.g., modular electrodes 352). For example, an electrical signal can be driven between the ring electrodes 434a and / or 434b on the deployment member 235 and each of the multiple sensors 826 according to any of the methods described herein. Additionally 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. Additionally or alternatively, an electrical signal can be driven between two or more electrodes of one of the sensors 826. Measured electrical signals generated between (i) at least one of the sensors 826 and another of the sensors 826, (ii) at least one of the sensors 826 and ring electrodes 434a and / or 434b, (iii) at least one of the sensors 826 and at least one additional sensor formed by and / or positioned on electrical conductor 806, and / or (iv) two or more electrodes of at least one of the sensors 826 can be received in processing unit 110 (FIG. 1).

[0097] Based at least in part on the measured electrical signals, the shape of the expandable portion 250 (e.g., the degree of expansion and / or deformation) can be detected. For example, as the expandable portion 250 is deformed, one or more of the sensors 826 can be brought into contact with the deployment member 235. It should be understood that a certain amount of force is required to deform the expandable portion 250 at least an amount sufficient to bring the one or more sensors 826 into contact with the deployment member 235 while the expandable portion 250 is in a fully deployed (uncompressed) state. As used herein, this force can be considered a threshold in the sense that at least a force below this threshold is insufficient to bring the one or more sensors 826 into close proximity with the deployment member 235 and thus is not detected as contact between the one or more sensors 826 and the deployment member 235.

[0098] In some embodiments, a shaft electrode (e.g., a ring electrode on the shaft (not shown)) can be mounted on the distal end portion 232 of the shaft 122 near the neck portion 357 (e.g., on or adjacent to the coupling 367). The shaft electrode can be used to measure an electrogram according to various methods described herein. Additionally or alternatively, electrical energy (e.g., current) can be driven through the shaft electrode and one or more other electrodes (e.g., any one or more of the various different electrodes described herein), and a change in the measured signal (e.g., voltage or impedance) can indicate the presence of an introducer sheath covering the shaft electrode. Continuing with this example, the measured signal from the shaft electrode can be used in combination with the measured signal from the sensor 826 to determine the location of the introducer sheath relative to the tip section 124 and / or the distal end portion 232 of the shaft 122.

[0099] 8D-10B, tip section 124 may further include one or more location determining coil sensors (e.g., magnetic coil sensors). For example, coupling 365 and / or coupling 367 may include one or more slots or notches for storing and / or retaining one or more location determining coil sensors 931 (FIGS. 8D-9B) and one or more location determining coil sensors 1031 (FIGS. 8D, 10A, and 10B), respectively. Additionally or alternatively, tip section 124 may include a location determining coil sensor 1032 (FIGS. 8D, 10A, and 10B) mounted on one or more of posts 755 and / or 757.

[0100] In some embodiments, localization 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, such as other of coil sensors 931, 1031, and / or 1032) can be used to measure the resulting magnetic field. Additionally or alternatively, coils external to patient 102 can be configured to emit a magnetic field. In these and other embodiments, localization coil sensors 931, 1031, and / or 1032 can be configured to transmit and / or receive signals indicative of information related to three to six degrees of freedom. For example, the localization coil sensors 931, 1031, and / or 1032 can transmit and / or receive signals indicative of position information of the coil sensors 931, 1031, and / or 1032 in three-dimensional space (e.g., signals indicative of x, y, and z position coordinates relative to a defined origin, such as an external reference frame, and / or relative to one or more of the localization coil sensors 931, 1031, and / or 1032). Additionally or alternatively, the localization coil sensors 931, 1031, and / or 1032 can transmit and / or receive signals indicative of pitch, yaw, and / or roll information. Thus, the localization coil sensors 931, 1031, and / or 1032 can be used to resolve the location of the tip section 124 (e.g., within the patient 102) relative to a defined origin and / or can be used to computationally determine the shape and / or orientation (e.g., pose) of the expandable portion 250. Additionally or alternatively, the location coil sensors 931, 1031, and / or 1032 can be used to (i) determine the distance between the coil sensors 931 and 1031, and / or (ii) determine the distance and / or angle between the coil sensors 931, 1031, and / or 1032.The determined distance and / or angle can then be used to determine and / or estimate the shape (eg, degree of expansion and / or deformation) of the expandable portion 250.

[0101] 8D, various components of tip segment 124 can be used alone or in combination to determine the position, shape (e.g., level of expansion and / or deformation), and / or orientation of tip segment 124 (e.g., expandable portion 250). For example, as discussed above, location and / or orientation information can be provided by localization coil sensors 931, 1031, and / or 1032. Additionally or alternatively, fluoroscopic visualization (e.g., x-ray, CT, etc.) can be used to determine the position, shape, and / or orientation of tip segment 124. For example, in some embodiments, at least a portion of tip segment 124 is radiopaque and expandable portion 250 is observable through the use of fluoroscopy or other similar visualization techniques. In some embodiments, the expandable portion 250 of the tip section 124 can be radiopaque such that fluoroscopy can provide an indication of deformation and / or partial deformation of the expandable portion 250 and therefore whether the expandable portion 250 is in contact with tissue. Additionally or alternatively, one or more of the shaft 122, the deployment member 235, the coupler 367, the coupler 365, and / or the sensor 826 can be constructed from and / or coated with a radiopaque material and thus be visible using fluoroscopy or other visualization techniques.

[0102] As a specific example, the portion of the deployment member 235 encompassed by the expandable portion 250 of the tip section 124 can include three concentric tubes. Each of the concentric tubes can include a radiopaque ring, and all three rings can be distinct (e.g., separated) under fluoroscopy when the deployment member 235 is fully distally expanded (e.g., when the expandable portion 250 is in a fully compressed state). As the deployment member 235 is retracted (e.g., as the distal-most portion 240 of the tip section 124 is moved proximally), the distal concentric tube of the deployment member 235 slides within the more proximal concentric tube of the deployment member 235 such that the radiopaque ring on the distal concentric tube becomes superimposed within the more proximal concentric tube during fluoroscopy. Thus, the extent of deployment of the expandable portion 250 can be determined, at least in part, based on the relative positions of the radiopaque rings on the deployment member 235. The portion of the deployment member 235 encompassed by the expandable portion 250 of the tip section 124 may, in other embodiments, include a greater number (e.g., four or more) or a lesser number (e.g., two) of concentric tubes per concentric tube, and / or may include a different number (e.g., two or more) of radiopaque rings.

[0103] Additionally or alternatively, the coupler 367 can include a radiopaque ring. In some embodiments, the radiopaque ring on the coupler 367 can be clearly and distinctly different (e.g., via size and / or pattern) from radiopaque elements on other components of the catheter 104 (e.g., from radiopaque rings on the deployment member 235). Thus, the radiopaque ring on the coupler 367 can provide orientation (e.g., pose) information of the tip section 124 during fluoroscopic visualization.

[0104] In some embodiments, the shape (e.g., degree of deployment, deformation, etc.) of the expandable portion 250 can be predicted based on the position of the deployment member 235. A displacement measuring device (a potentiometer, encoder, or other device known in the art) in the handle 120 can be used to measure the displacement of the deployment member 235. The measured displacement can be used by the processing unit 110 (FIG. 1) to determine the shape of the expandable portion 250 for display on the graphical user interface 109 (FIG. 1).

[0105] In these and still 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, impedance detected by an electrode pair (e.g., pair of sensors 826, sensor 826 and ring electrode 434a (FIG. 4), sensor 826 and ring electrode 434b (FIG. 4), etc.) can be detected (e.g., as a signal received by processing unit 110 (FIG. 1)) when an electrical signal is driven through the electrode pair. The impedance detected across the various electrode pairs can be compared to each other and to the determined relative distances between the members of each electrode pair. For example, if the sensors 826 are the same, each sensor 826 can be driven as part of an individual electrode pair that includes ring electrode 434a and / or ring electrode 434b of the deployment member 235. For each such electrode pair, the impedance measured across the electrode pair can indicate the relative distance between the particular sensor 826 and the ring electrodes 434a and / or 434b that form the individual electrode pair. In implementations in which electrical signals are driven through electrode pairs while the deployment member 235 is at steady state, the relative distance between each sensor 826 and the deployment member 235 can further indicate the relative distance between each sensor 826 and each of the other sensors 826. Generally, driven electrode pairs with lower measured impedances are closer to each other than those driven electrode pairs with higher measured impedances. In some cases, electrodes associated with undriven modular electrodes 352 (e.g., one or more of the sensors 826) can be measured to determine additional information regarding the position of the drive current pairs.

[0106] Measurements associated with the drive current pairs received by the processing unit 110, alone or in combination with measurements at the unactuated sensor 826, can be fitted to a model and / or compared to a look-up table to determine the displacement of the expandable portion 250 of the tip section 124. For example, the determined displacement of the expandable portion 250 can include a displacement in at least one of an axial or lateral (radial) direction. It should be understood that due to spatial separation of the current pairs in three dimensions, the determined displacement of the expandable portion 250 can be in more than one direction (e.g., axial, lateral, and combinations thereof). Additionally or alternatively, the determined displacement of the expandable portion 250 can correspond to a three-dimensional shape of the expandable portion 250 of the tip section 124. Thus, the determined displacement of the expandable portion 250 can be used, for example, to determine the shape of the expandable portion 250. Additionally or alternatively, signals measured by ultrasonic transducers, optical fibers, and / or other types of image sensors contained within the sensor 826 and / or disposed on the deployment member 235 can be used to determine the displacement (and thus the shape) of the expandable portion 250.

[0107] In embodiments where the axial force displacement and / or lateral force displacement response of the expandable portion 250 may be repeatable for a given deployment state, the amount of force applied to the expandable portion 250 of the tip section 124 in the axial and / or lateral directions can be reliably determined based on the individual displacement of the expandable portion 250 in a given deployment state. Thus, 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. In particular, 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 predefined 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 according to any one or more of the methods for determining displacement described herein. Thus, it will be appreciated that the reproducible relationship between force and displacement along the expandable portion 250, coupled with the ability to determine displacement using sensors 826 positioned along the modular electrodes 352, can facilitate determining whether an appropriate amount of force is being applied during an ablation procedure, and can additionally, or alternatively, facilitate determining appropriate energy and cooling doses for lesion formation.

[0108] Detecting and / or observing the position, shape, and / or orientation of the tip section 124 can provide, for example, improved certainty that the expandable portion 250 is engaging tissue and / or that the intended treatment is being provided to the tissue in effect. It should be appreciated that improved certainty of the positioning of the modular electrode 352 relative to the tissue can improve the likelihood that energy is applied to the tissue in the correct location within the patient and / or reduce the likelihood of inducing a stenosis in the pulmonary vein and / or a gap in the lesion pattern around the ostium of the pulmonary vein.

[0109] In some embodiments, the graphical user interface 109 (FIG. 1) can be used to display various information collected by the tip section 124 of the catheter 104. For example, the graphical user interface 109 can be used to display the catheter 104 with icons representing the location, orientation, and / or shape of the tip section 124 and shaft 122 on a mapping system (e.g., within a model of the anatomy of the patient 102). For example, based on the determined displacement of the expandable portion 250 of the tip section 124, the processing unit 110 (FIG. 1) can send an indication of the shape of the expandable portion 250 to the graphical user interface 109. Such an indication of the shape of the expandable portion 250 can include, for example, a graphical representation of the shape of the expandable portion 250 corresponding to the determined deformation. In these and other embodiments, the graphical user interface 109 can be used to display a treatment location (e.g., a lesion location). Additionally or alternatively, the graphical user interface 109 can be used to display other information corresponding to the tip section 124 of the catheter 104. For example, the graphical user interface 109 can be used to display voltage and / or temperature measurements captured by one or more of the sensors 826. As a specific example, the graphical user interface 109 can be used to display a representation of at least one of an electrogram and / or other information corresponding to the tip section 124 of the catheter 104 (e.g., a voltage map associated with the electrogram) measured by one or more of the sensors 826, the central electrode, and / or one or more additional sensors formed by and / or positioned on one or more of the electrical leads 806.As another example, the graphical user interface 109 can be used to display an electroanatomical map based, at least in part, on the electrogram and / or the determined shape and / or location of the tip segment 124.

[0110] 11A-15 illustrate a tip section 124 configured in accordance with various other embodiments of the present technology. The tip section 124 illustrated in FIG. 11A-15 is similar to the tip section 124 illustrated in FIG. 2-10B. Thus, similar reference numbers are used to indicate similar elements across FIG. 2-15, although the individual components may not be the same. The tip section 124 illustrated in FIG. 11A-15 differs from the tip section 124 illustrated in FIG. 2-10B in that the struts 751, 755, and 757 of the individual mesh electrode panels 750 are sized (struts 755 and 757 are attached to couplers 365 and 367, respectively) to contribute to the general "onion" and / or general "pumpkin" shapes of the expandable portions 1150 and 1550, rather than the general "pear" shape of the expandable portion 250 of the tip section 124 illustrated in FIG. 2-10B.

[0111] 11A and 11B illustrate the "onion" shaped expandable portion 1150 of the tip section 124 in a deployed state. FIGS. 12A and 12B are top and top perspective views, respectively, of the distal-most portion 240 of the expandable portion 1150. As best shown in FIGS. 11A and 11B, the illustrated expandable portion 1150 of the tip section 124 includes a neck portion 1157 and an actuating body portion 1152 (hereinafter referred to as the "modular electrode 1152"). Notably, the expandable portion 1150 does not include an accentuated nose portion similar to the nose portion 355 of the expandable portion 250 illustrated in FIGS. 2-10B. 11A-12B together, the distal portion of the modular electrode 1152 (at least when the expandable portion 1150 is in a fully deployed state) can form a distal surface that is approximately normal to the deployment member 235 and can be positioned relatively flat against tissue (e.g., around the ostium of a pulmonary vein). Thus, the struts 755 of the mesh electrode panel of the expandable portion 1150 can contribute to the modular electrode 1152. Thus, all or a portion of the struts 755 of the expandable portion 1150 can abut tissue (e.g., around the ostium of a pulmonary vein) and / or be used to deliver energy to tissue, in some embodiments. Additionally or alternatively, all or a portion of the struts 755 of the expandable portion 1150 can be insulated such that the insulated portions of the struts 755 can abut tissue but not be used to deliver energy to tissue.

[0112] FIG. 13 illustrates a side perspective view of the expandable portion 1150 of the tip section 124. As shown, the sensors 826 are distributed about the expandable portion 1150 and are electrically coupled to the electrical leads 806, consistent with the discussion above with respect to FIGS. 2-10B. One or more of the electrical leads 806 illustrated in FIG. 13 include one or more additional sensors 1326 formed by and / or positioned on the electrical leads 806 in a manner such that when the expandable portion 1150 is in contact with tissue, the additional sensors 1326 remain within the interior of the expandable portion 1150 and do not contact 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), determine the shape of the expandable portion 1150 (e.g., degree of deployment, deformation, etc.), etc. The additional sensors may be coated with platinum black, iridium oxide, or gold (eg, to reduce electrical impedance or noise and / or increase thermal conductivity).

[0113] To allow for deployment and compression of the expandable portion 1150, a service loop 1306 can be included in some embodiments for one or more of the electrical leads 806. The service loop 1306 can be maintained in place within the expandable portion 1150 by a variety of means, including (i) wrapping or spiraling the electrical leads 806 around the deployment member 235, or (ii) joining two or more electrical leads 806 in a "Y" shape that at least partially engages the deployment member 235.

[0114] Figures 14A - 14C illustrate a method by which the mesh electrode panel 750 can be attached to form an expandable portion 1150 of the tip section 124, consistent with the discussion of FIGS. 8A - 8C above. For example, the small holes 758 of adjacent mesh electrode panels 750 can be aligned (overlapped) and held together using fasteners 870. A polymer disk 872 formed from an electrically insulating material can be used to separate and electrically insulate adjacent mesh electrode panels 750 from each other and / or from the sensors 826 contained within the fasteners 870. Additionally, or alternatively, a dovehole 873 (FIG. 14A) can be placed within the orifice of the aligned small holes 758 between the sensor 826 and the panel 750 (e.g., to electrically insulate the sensor 826 from the panel 750).

[0115] A encapsulated material 874 can be formed over the fasteners 870 and / or the back side of the sensors 826 (e.g., to electrically insulate a portion of the sensor 826 that is not in contact with tissue, to electrically insulate the sensor 826 from the panel 750, and / or to electrically insulate the individual panels 750 from each other). In some embodiments, the encapsulated material 874 can be an adhesive that cures in place. In other embodiments, the encapsulated material 874 can be a reflow thermoplastic or another insulator.

[0116] The struts 751 of the panel 750 illustrated in FIGS. 14A - 14C include one or more features or bends 1450 proximate to the corresponding small holes 758. When these panels 750 are attached to each other, the bends 1450 within the struts 751 can facilitate placing the sensor 826, which is contained within the sensor 826 of the fastener 870, into a recess relative to the outside of the expandable portion 1150. As discussed above, this can be advantageous, for example, in allowing the expandable portion 1150 to pass smoothly in and out of the introducer sheath (e.g., without the corresponding sensor 826 catching on the edge of the introducer sheath at one or more openings of the sheath).

[0117] 15 illustrates the expandable portion 1550 of the tip section 124 in a deployed state. The expandable portion 1550 is similar to the expandable portion 1150 illustrated in FIGS. 11A-14C, except that the struts 755 of the panel 750 are attached to a distal-most portion of the coupler 365. Thus, the struts 755 emerge distally from the coupler 365 to form an inverted nose portion 1555. The inverted nose portion 1555 includes the distal-most portion 1540 of the expandable portion 1550 and prevents the coupler 365 (e.g., the distal-most portion 240 of the tip section 124) from contacting tissue when the expandable portion 1550 is in a fully (or substantially fully) deployed state. This can be advantageous, for example, to deliver energy to tissue using a distal face or surface of the expandable portion 250 without interference from the coupler 365. Thus, in some embodiments, all or a portion of the struts 755 of the expandable portion 1550 can abut tissue and / or be used to deliver energy to tissue. Additionally or alternatively, all or a portion of the struts 755 of the expandable portion 1550 can be insulated such that the insulated portions of the struts 755 can abut tissue but are not used to deliver energy to tissue. 2. How it is related

[0118] FIG 16 is a schematic illustration of the tip section 124 of FIGS. 2-10B positioned at a treatment site within a patient's anatomy (in this case, proximate the mouth 1613 of a pulmonary vein 1611 in the left atrium of the patient's heart 1610) in accordance with various embodiments of the present technology. For clarity and illustration, FIGS. 17 and 18 are discussed below in conjunction with FIG. 16. However, one skilled in the art will readily recognize that all or a portion of the method described in FIGS. 17 and 18 may be applied using a tip section 124 configured in accordance with various other embodiments of the present technology, such as a tip section 124 having an expandable portion within a modular electrode similar to the expandable portion 1150 and / or 1550 with modular electrode 1152 illustrated in FIGS. 11A-15. In addition, one skilled in the art will readily recognize that all or a portion of the methods described in Figures 17 and 18 may be applied in situations other than pulmonary vein isolation procedures, such as in any of a variety of medical procedures performed on a patient's hollow anatomical structures, and more particularly, in procedures for diagnosing, stimulating, electrically isolating, or treating tissue within and / or proximal to the anatomical structures.

[0119] 17 is a flow diagram illustrating a method 1740 of positioning a tip section of a catheter at a treatment site in a patient's anatomy, according to various embodiments of the present technology. All or a subset of the steps of the method 1740 can be performed by various components or devices of a medical system, such as the system 100 illustrated in FIG. 1, or other suitable system. For example, all or a subset of the steps of the method 1740 can be performed by (i) components or devices of the interface unit 108, (ii) components or devices of the medical device 104, and / or (iv) the mapping system 112, the recording system 113, the fluid pump 114, and / or the generator 115. Additionally or alternatively, all or a subset of the steps of the method 1740 can be performed by a user (e.g., an operator, a physician, etc.) of the system 100. Furthermore, any one or more of the steps of the method 1740 can be performed in accordance with the discussion above.

[0120] 16 and 17 together, a method 1740 begins at block 1741 by delivering a tip section 124 of the catheter 104 to a treatment site in a patient's anatomy. For example, the tip section 124 can be inserted into the patient in a compressed state and delivered into the patient's heart 1610 via a vein in the patient's leg or arm. In some embodiments, the tip section 124 can be passed using an introducer sheath (e.g., a steerable introducer sheath such as the Abbott Agilis) and / or a guidewire 397 to a pulmonary vein 1611 in the patient's heart (e.g., an ostium 1613 of the pulmonary vein 1611 in the left atrium of the patient's heart 1610). In these and other embodiments, fluoroscopy and / or other visualization techniques can be used to pass the tip section 124 to the treatment site. In these and still other embodiments, positioning information provided by location coil sensors 931, 1031, and / or 1032 and / or sensor 826 distributed around the deformable portion 250 of the tip section 124 can be used to pass the tip section 124 to the treatment site.

[0121] At block 1742, the expandable portion 250 of the tip section 124 is deployed at the treatment site. For example, the expandable portion of the tip section 124 can be deployed by retracting the deployment member 235 of the tip section 124 relative to the distal end portion 232 of the shaft. In some embodiments, the deployment can include retracting the deployment member 235 using an actuation portion 246 (FIG. 2) on the handle 120 (FIG. 2) of the catheter 104.

[0122] To deploy the expandable portion 250 of the tip section 124, a nose portion 355 of the expandable portion 250 can be advanced into the pulmonary vein 1611 in a compressed state and then expanded to a deployed state that corresponds to the size of the pulmonary vein 1611. As the expandable portion 250 expands, the nose portion 355 can engage the walls of the pulmonary vein 1611 and center the nose portion 355 within the pulmonary vein 1611. Additionally or alternatively, the pear shape of the expandable portion 250 can allow the walls of the pulmonary vein 1611 to push at least a portion of the modular electrode 352 of the expandable portion 250 out of the mouth of the pulmonary vein 1611 and into the left atrium of the heart 1610, thereby preventing a portion of the modular electrode 352 from engaging tissue within the pulmonary vein 1611. In this manner, the tip section 124 of the catheter 104 can be expanded to a size corresponding to the size of the pulmonary vein 1611 while ensuring that only the insulated portion of the expandable portion 250 extends beyond the ostium of the pulmonary vein 1611 and that the active portion of the expandable portion 250 (i.e., the modular electrode 352) is properly positioned relative to tissue in the left atrium of the heart 1610 around the ostium 1613 of the pulmonary vein 1611 (as opposed to tissue within the pulmonary vein 1611). Thus, narrowing of the pulmonary vein 1611 as a result of the procedure is reduced.

[0123] In other embodiments, to deploy the expandable portion 250 of the tip section 124, the expandable portion 250 can be expanded to a deployed state prior to advancing at least a nose portion 355 of the expandable portion 250 into the pulmonary vein 1611. For example, the expandable portion 250 can be expanded to a fully deployed state or to the approximate size of the pulmonary vein 1611. The nose portion 355 of the expandable portion 250 is then advanced toward and / or into the pulmonary vein 1611. If the nose portion 355 is successfully advanced into the pulmonary vein 1611, the expandable portion 250 can be further expanded, in some embodiments, until the nose portion 355 engages the wall of the pulmonary vein 1611 and is centered within the pulmonary vein 1611. On the other hand, if the nose portion 355 cannot be successfully advanced into the pulmonary vein 1611, the expandable portion 250 can be compressed via distal movement of the deployment member 235 relative to the distal end portion 232 of the shaft 122 until the nose portion 355 is successfully advanced into the pulmonary vein 1611.

[0124] In these and still other embodiments, the expandable portion of the tip section 124 can be expanded to a deployed state until the nose and / or distal portion of the modular electrode forms a distal surface that is approximately normal to the deployment member 235. The distal surface can then be positioned relatively flat against tissue around the ostium 1613 of the pulmonary vein 1611 (e.g., at least a portion of the coupler 365 and / or struts 755 are positioned within the pulmonary vein 1611).

[0125] At block 1743, the method 1740 verifies that the tip section 124 is properly positioned at the treatment site. In particular, the method 1740 verifies that the modular electrode 352 (e.g., its distal surface) engages tissue in the left atrium of the heart 1610 around the ostium 1613 of the pulmonary vein 1611. Additionally or alternatively, the method 1740 verifies that the tip section 124 (e.g., nose portion 355) is centered within the pulmonary vein 1611. In these and other embodiments, the method 1740 verifies that the strut 755, rather than the coupler 365, is properly positioned relative to the tissue.

[0126] In some embodiments, to verify placement of the tip segment 124 within the pulmonary vein 1611, a guidewire 397 can be further advanced into the pulmonary vein 1611 and / or contrast can be injected into the pulmonary vein 1611 (e.g., out of the opening of the lumen 349 of the deployment member 235) to verify proper placement. In these and other embodiments, the position, shape (e.g., level of deformation and / or expansion), and / or orientation of the tip segment 124 can be determined according to any one or more of a variety of different methods described herein (e.g., fluoroscopic visualization, position and / or orientation information provided by localization coil sensors 931, 1031, and / or 1032, impedance measurements using sensor 826 and / or ring electrodes 434a and / or 434b of the deployment member 235, etc.) to verify positioning of the tip segment 124 at the treatment site. In these and still other embodiments, to verify proper positioning of the tip section 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 can be determined according to any one or more of a variety of different methods described herein.

[0127] Although the steps of method 1740 are discussed and illustrated in a particular order, the method 1740 illustrated in FIG. 17 is not so limited. In other embodiments, the method 1740 can be performed in a different order. In these and other embodiments, any of the steps of the method 1740 can be performed before, between, and / or after any of the other steps of the method 1740. Also, one of ordinary skill in the art will recognize that the illustrated method can be modified and still remain within these and other embodiments of the present technology. For example, one or more steps of the method 1740 illustrated in FIG. 17 can be omitted and / or repeated in some embodiments.

[0128] FIG. 18 is a flow diagram illustrating a method 1850 of diagnosing and / or treating tissue at a treatment site in a patient's anatomy in accordance with various embodiments of the present technology. For example, FIG. 18 is a flow diagram illustrating a method 1850 of diagnosing and / or treating tissue in the left atrium of a patient's heart 1610 (FIG. 16) around the ostium 1613 (FIG. 16) of a pulmonary vein 1611 (FIG. 16) to electrically isolate the pulmonary vein 1611 from the patient's heart 1610. All or a subset of the steps of the method 1850 can be performed by various components or devices of a medical system, such as the system 100 illustrated in FIG. 1 or other suitable system. For example, all or a subset of the steps of the method 1850 can be performed by (i) components or devices of the interface unit 108, (ii) components or devices of the medical device 104, and / or (iv) the mapping system 112, the recording system 113, the fluid pump 114, and / or the generator 115. Additionally or alternatively, all or a subset of the steps of method 1850 may be performed by a user (e.g., an operator, a physician, etc.) of system 100. Further, any one or more of the steps of method 1850 may be performed in accordance with the discussion above.

[0129] 16 and 18 together, the method 1850 begins at block 1851 by determining the position, shape, contact, and / or orientation of the tip section 124 of the catheter 104 at the treatment site. For example, the position, shape, contact, and / or orientation of the tip section 124 can be determined according to any one of the various methods described herein and / or in a similar manner described above with respect to block 1243 of method 1240 (FIG. 12). In some embodiments, the size and / or effective surface area of ​​the expandable portion 250 of the tip section 124 corresponding to a current level of deployment (expansion) of the expandable portion 250 can be determined. In these and other embodiments, the portion of the modular electrode 352 (e.g., which mesh electrode panel 750 (FIGS. 7A and 7B), which portion of an individual panel, etc.) that is currently in contact with tissue at the ostium 1613 of the pulmonary vein 1611 can be determined. In these and still other embodiments, the effective surface area of ​​the modular electrode 352 (eg, of the modular electrode 352 as a whole, of each individual panel, etc.) that contacts the tissue surrounding the treatment site can be determined.

[0130] At block 1852, the method 1850 can diagnose and / or treat tissue at the treatment site. In some embodiments, the tissue is diagnosed by measuring a property of the tissue according to any one or more of the various methods described herein. For example, the electrical signal of the tissue can be measured using one or more of the sensors 826 distributed around the modular electrode 352, using the modular electrode 352 itself, using the ring electrodes 434a and / or 434b of the deployment member 235, and / or using one or more of the additional sensors 1326 ( FIG. 13 ) formed by and / or positioned on one or more of the electrical leads 806. Based at least in part on the measured electrical signals, one or more electrograms and / or electroanatomical maps corresponding to tissue in contact with and / or in proximity to the sensor 826, one or more of the additional sensors 1326 formed by and / or positioned on one or more of the modular electrodes 352, the ring electrodes 434a and / or 434b, and / or the electrical leads 806 can be generated. In this manner, the method 1850 can (i) identify tissue exhibiting abnormal electrical behavior that may contribute to a medical condition of the patient 102 (e.g., to atrial fibrillation) and / or (ii) track the electrical behavior of the tissue as it is treated. In these and other embodiments, the tissue can be diagnosed by measuring electrical activity (e.g., using one or more of the sensors 826) and / or by pacing the heart 1610 of the patient 102. In these and still 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 based on other measurements captured by the catheter 104).

[0131] In some embodiments, energy (e.g., electrical energy) can be delivered to select a panel of modular electrodes 352 to treat tissue at a treatment site. Selecting a panel of modular electrodes 352 can then deliver energy to the tissue. For example, radio frequency (RF) energy can be delivered to one or more panels of modular electrodes 352 using generator 115 (FIG. 1). As a more specific example, method 1850 can deliver approximately 1-4 amps (e.g., about 2-3 amps, or about 2.6 amps) at approximately 500 kHz (e.g., 400 kHz and 600 kHz) to each panel together and / or separately for about 4 seconds (e.g., 2-9 seconds overall, 3-5 seconds per panel, etc.). In some embodiments, parameters of the RF energy delivered to tissue through modular electrodes 352 can be adjusted (e.g., modified) based on various factors, as discussed in more detail below.

[0132] As another example, pulsed magnetic field ablation (e.g., irreversible electroporation) and / or another form of energy can be delivered to one or more of the panels of modular electrodes using generator 115 to treat tissue at the treatment site. As a more specific example, method 1850 can deliver approximately 18-60 amps (e.g., about 20-26 amps, or about 24 amps) to each panel together and / or separately using approximately 1 microsecond (e.g., 0.5-5 microsecond) biphasic pulses repeated approximately every 1 ms (e.g., 0.5-10 ms) for a total of approximately 3 seconds (e.g., 1.5-10 seconds).

[0133] Additionally or alternatively, the method 1850 can use the generator 115 to deliver various forms of pulse train energy to one or more of the panels of modular electrodes. For example, the method 1850 can deliver a train of closely spaced (e.g., in time) pulses of energy followed by a hold period during which no energy is delivered. At the end of the hold period, the method 1850 can deliver another train of closely spaced pulses of energy followed by another hold period. The method 1850 can repeat this cycle as necessary. In still other embodiments, the method 1850 can vary the amount of current delivered during different pulses (e.g., of the pulse train). In some embodiments, parameters of the pulsed magnetic field and / or other energy delivered to tissue through the modular electrodes 352 can be adjusted (e.g., modified) based on various factors discussed in more detail below.

[0134] In these and other embodiments, the channels, repeaters, and / or transistors of the generator 115 (FIG. 1) can be used to drive the mesh electrode panels of the expandable portion 250 separately and / or in parallel to treat tissue at the treatment site. In some embodiments, all or a subset of the panels of the modular electrodes 352 can be driven in a monopolar electrode configuration (e.g., between the panels and one or more return electrodes 118 (FIG. 1) that are external to the patient 102 (FIG. 1)). In embodiments having multiple return electrodes 118, the method 1850 can balance the current returned through each of the electrodes 118. More information regarding current balancing between return electrodes can be found, for example, in U.S. Patent Application Serial No. 16 / 493,288, assigned to Affera, Inc., which is incorporated herein by reference in its entirety. Alternatively, the panels can be driven in a bipolar electrode configuration. For example, the method 1850 can deliver energy between adjacent panels and / or separated (e.g., opposed) panels, and / or the method 1850 can deliver energy between one or more mesh electrode panels and a central electrode (e.g., a ring electrode on the deployment member and / or another electrode in the tip section 124).

[0135] In some embodiments, the method 1850 includes driving each of the mesh electrode panels together. In these and other embodiments, the method 1850 includes driving each panel separately from one another. For example, assuming the expandable portion 250 includes six panels, the method 1850 can drive the panels in the following order: (i) the first panel, (ii) the second panel, (iii) the third panel, (iv) the fourth panel, (v) the fifth panel, and (vi) the sixth panel. In some embodiments, time division is used to drive the panels of the expandable portion 250 separately.

[0136] In these and still other embodiments, method 1850 can include simultaneously driving panels in various subgroups. For example, assuming expandable portion 250 includes six panels, method 1850 can drive the panels in the following order: (i) the first panel with the second panel adjacent to the first panel, (ii) the second panel with the third panel adjacent to the second panel, (iii) the third panel with the fourth panel adjacent to the third panel, (iv) the fourth panel with the fifth panel adjacent to the fourth panel, (v) the fifth panel with the sixth panel adjacent to the fifth panel, and (vi) the sixth panel with the first panel adjacent to the sixth panel. In these and still other embodiments, the method 1850 can drive other groups of panels (e.g., a group of two panels that are opposite each other on the expandable portion 250, a group of two panels separated by an adjacent panel, a group of three or more panels, any other group of panels, etc.). Other groups of panels are, of course, possible and within the scope of the present technology. In some embodiments, time division is used to drive the groups of panels separately.

[0137] When panels of the expandable portion 250 are actuated separately to treat tissue, the method 1850 may perform only one instance of energy delivery per panel. In other embodiments, the method 1850 may perform multiple (e.g., fewer) instances of energy delivery per panel. For example, the method 1850 can sequentially energize each panel a first time after the method 1850 sequentially energizes each panel a second time. In some embodiments, the multiple instances of energy delivery per panel can allow the panels to cool after the method 1850 actuates the panels and before the method 1850 subsequently actuates the panels again.

[0138] Selectively activating panels of modular electrodes provides several advantages over conventional pulmonary vein isolation catheters. For example, instead of delivering a large amount of energy (e.g., 900 J) all at once into the patient 102, the method 1850 can deliver a smaller amount of energy per panel (e.g., 150 J per panel for an expandable portion 250 with six panels) to deliver the same total amount of energy into the patient 102 over time while also maintaining the same or similar current density across the expandable portion 250 (because the effective surface area of ​​a subset of the panels is smaller than the effective surface area of ​​the entire expandable portion 250). Additionally or alternatively, the degree of tissue contact, the degree of panel deployment / deformation, and other characteristics of the tissue at the treatment site and / or of the individual panels may vary across the expandable portion 250. Thus, selectively driving panels of modular electrode 352 according to tissue characteristics local to the panels and other factors provides greater granularity and control of the energy delivered to tissue at the treatment site through each portion of modular electrode 352, as described in more detail below.

[0139] In some embodiments, energy delivery can be synchronized with the refractory period of ventricular activation. For example, the method 1850 can trigger energy delivery to the modular electrode 352 at a predetermined time delay relative to when the method 1850 detects ventricular activation via an electrode (e.g., the modular electrode 352, one or more of the sensors 826, etc.) and / or paces the ventricle.

[0140] In these and other embodiments, the method 1850 can adjust the energy delivered to the modular electrode 352 based on various factors. In some embodiments, the position, shape, contact, and / or orientation information of the tip section 124 determined in block 1851 and / or the characteristics of the tissue determined during the diagnosis of the tissue in block 1852 can be used to adjust the energy delivered to the tissue via the modular electrode 352. For example, the energy delivery can be adjusted based on the anatomical location of the tissue. As a specific example, the method 1850 can determine that a first panel is contacting a thinner (e.g., posterior) section of tissue at the treatment site and that a second panel is contacting a thicker (e.g., anterior) section of tissue at the treatment site. Thus, the method 1850 can, in some embodiments, deliver less energy via the first panel of the modular electrode 352 contacting the thinner section of tissue than the energy delivered to the thicker section of tissue via the second panel.

[0141] In these and other embodiments, because the current density at a given point along the modular electrode 352 is a function of the effective surface area at a given point along the modular electrode 352, the energy delivered to the panels of the modular electrode can be adjusted based on the shape (e.g., level of expansion and / or deformation) of the expandable portion 250 to maintain a target current density of energy delivered to the tissue through each panel of the modular electrode 352 that contacts the tissue. For example, a pulmonary vein having a smaller diameter will require less energy overall to treat tissue around the ostium of the smaller pulmonary vein than a pulmonary vein having a larger diameter. Following this example, the expandable portion 250 will be less deployed (and therefore have a smaller effective surface area) when properly positioned in a smaller pulmonary vein than the expandable portion 250 when properly positioned in a larger pulmonary vein. Thus, the method 1850 can deliver less energy to the panels of the modular electrode 352 when the modular electrode 352 is positioned in a smaller pulmonary vein and can deliver more energy to the panels of the modular electrode 352 when the modular electrode 352 is positioned in a larger pulmonary vein. As an additional example, a first panel of the modular electrode 352 can be deformed more (e.g., through contact with tissue) and / or have a lesser amount of the first panel in contact with tissue than a second panel of the modular electrode 352. In either or both of these scenarios, the method 1850 can determine that the first panel has a smaller effective surface area than the second panel and therefore can deliver less energy to the first panel than the second panel to maintain a target current density of energy delivered to tissue through each panel of the expandable portion 250.

[0142] At block 1853, various 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 of the sensors 826 may measure the temperature of the tissue and / or a portion of the modular electrode 352. In these embodiments, the amount and / or temperature of irrigation fluid delivered to the treatment site may be varied based at least in part on the temperature measurements. For example, the method 1850 may increase the flow rate and / or decrease the temperature of irrigation fluid delivered to the modular electrode 352 and / or tissue at the treatment site as the temperature of the tissue and / or the temperature of the portion of the modular electrode 352 increases. Additionally or alternatively, the energy delivered to a panel of the modular electrode 352 may be adjusted based at least in part on temperature measurements captured by one or more sensors 826 corresponding to and / or proximate to the panel. For example, the method 1850 may decrease or terminate the energy delivered to a panel when a temperature measurement corresponding to the panel meets or exceeds a threshold temperature. In some embodiments, the method 1850 can wait to resume delivering energy to a panel until the temperature measurement corresponding to the panel drops below the threshold temperature. In this manner, the method 1850 can reduce the likelihood of coagulating or scorching the treated tissue. In some embodiments, the method 1850 can continue to deliver energy to tissue around the mouth via other panels of the modular electrode 352 when the temperature measurements corresponding to the other panels meet or fall below the threshold temperature or another temperature. Alternatively, the method 1850 can reduce or terminate energy delivered to other panels of the modular electrode 352 (e.g., all of the other panels, such as adjacent panels, a subset of the other panels, etc.) in addition to reducing or terminating energy delivered to a panel whose corresponding temperature measurement meets or exceeds the threshold temperature.

[0143] In these and other embodiments, the temperature measurements captured by one or more of the sensors 826 can be used for other purposes. For example, during RF or pulsed magnetic field energy delivery, an increase in temperature captured by the sensors 826 can indicate contact between the corresponding panel and tissue at the treatment site. Thus, the temperature measurements captured by one or more of the sensors 826 can be used to determine the portion of the modular electrode 352 that is in contact with tissue, and / or alternatively, the portion of the modular electrode 352 that is in unexpected contact with tissue (e.g., if the tip section 124 is moving unexpectedly relative to the treatment site). In this manner, the method 1850 can reduce the likelihood of treating tissue other than the target tissue at the treatment site. In other words, the method 1850 can increase the likelihood of accurately treating the target tissue at the treatment site. In these and still other embodiments, the temperature measurements can be used to determine lesion characteristics and adjust energy delivery accordingly.

[0144] In some embodiments, electrical activity of the target tissue at the treatment site can be monitored. For example, impedance can be monitored (i) between various pairs of sensors 826, (ii) between various ones of sensors 826 and ring electrodes 434a and / or 434b, (iii) between various electrodes of one or more sensors 826, and / or (iv) between various sensors and one or more additional sensors 1326 (FIG. 13) formed by and / or positioned on one or more of electrical leads 806. Impedance measurements can be used to determine the shape of expandable portion 250 (e.g., to determine that expandable portion 250 is unexpectedly deformed) and / or as feedback of lesion characteristics (as impedance changes as tissue is treated). As another example, electrograms provided by one or more of sensors 826 corresponding to tissue at the treatment site can be monitored. Such feedback may be useful in determining whether the procedure 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, the method 1850 may use one or more of a variety of parameters to inform and / or adjust the energy delivered in block 1852.

[0145] At block 1854, the method 1850 can selectively display various visual indicia. In some embodiments, the method 1850 can display a model of the anatomy. In these and other embodiments, the method 1850 can display an icon representing the position, shape, and / or orientation of the tip section 124 and / or shaft 122 (e.g., along or within the model of the anatomy). In these and still other embodiments, the method 1850 can selectively display various other information including electrograms and / or temperature measurements captured by one or more of the sensors 826, annotations indicating an area of ​​energy delivery (e.g., on the model of the anatomy, on an icon of the tip section to indicate the panel of the modular electrode 352 currently being actuated, on one or more icons representing one or more previous locations of energy delivery with the modular electrode 352, etc.), and / or current parameters (e.g., amperes, voltage, pulse parameters, frequency, activation time, etc.) of the energy delivered to the patient 102. In these and other embodiments, the method 1850 may include displaying information regarding the position (e.g., relative distance, relative axial translation, relative roll, etc.) of the modular electrode 352 compared to a previous (e.g., all previous, most recent, immediate past) energy delivery. This may assist the physician in establishing subsequent energy delivery to ensure contiguous ablation lesions across the desired treatment area.

[0146] At block 1855, the tip section 124 can be repositioned within and / or removed from the anatomy of the patient 102. For example, the tip section 124 can be repositioned relative to the target pulmonary vein 1611 (e.g., more inlet relative to the pulmonary vein 1611, or intraluminally, or rotated). As another example, the tip section 124 can be repositioned in another pulmonary vein (e.g., after successful electrical isolation of the first pulmonary vein 1611). As yet another example, the tip section 124 can be removed from the anatomy after completion of diagnosis and / or treatment of tissue at the treatment site. In some embodiments, the expandable portion 250 of the tip section 124 can be compressed before the tip section 124 is repositioned and / or removed. In these embodiments, the expandable portion 250 can be compressed via distal movement of the deployment member 235 relative to the distal end portion 232 of the shaft. When repositioning the tip section 124 after compressing the expandable portion 250, the expandable portion 250 can be redeployed via proximal movement of the deployment member 235 relative to the distal end portion 232 of the shaft 122.

[0147] Although the steps of method 1850 are discussed and illustrated in a particular order, method 1850 illustrated in FIG. 18 is not so limited. In other embodiments, method 1850 can be performed in a different order. In these and other embodiments, any of the steps of method 1850 can be performed before, between, and / or after any of the other steps of method 1850. Also, one of ordinary skill in the art will recognize that the illustrated method can be modified and still remain within these and other embodiments of the present technology. For example, one or more steps of method 1850 illustrated in FIG. 18 can be omitted and / or repeated in some embodiments.

[0148] C. Additional Examples Several aspects of the present technology are described in the examples below. 1. A catheter comprising: a shaft having a proximal end portion and a distal end portion; a tip section mechanically coupled to a distal end portion of the shaft, the tip section including a plurality of mesh electrode panels that together define an expandable portion; A catheter comprising: 2. The catheter of Example 1, wherein each mesh electrode panel comprises: (i) a first insulating portion and a second insulating portion axially distributed along the mesh electrode panel; and (ii) an active portion between the first insulating portion and the second insulating portion. 3. The catheter of example 1, wherein each mesh electrode panel comprises: (i) a first insulating portion; and (ii) an active portion distal to the first insulating portion. 4. A catheter described in any one of Examples 1-3, wherein each mesh electrode panel comprises a plurality of struts, a first subset of the plurality of struts defining a plurality of cells. 5. The catheter of example 4, wherein the plurality of cells at least partially define an open area of ​​the expandable portion, and wherein fluid, blood, or a combination thereof may flow through the open area. 6. A catheter described in any one of Examples 1-5, wherein the tip section further includes a deployment member mechanically coupled to the expandable portion at the distal-most portion of the tip section, and the expandable portion encases at least a portion of the deployment member between the distal end portion of the shaft and the distal-most portion of the tip section. 7. The catheter of example 6, wherein the deployment member is expandable. 8. The catheter of example 6 or example 7, wherein the expandable portion is configured to expand via proximal movement of the deployment member and to compress via distal movement of the deployment member along an axis defined by the shaft. 9. A catheter described in any one of Examples 6-8, wherein the deployment member defines a lumen configured to receive a guidewire. 10. A catheter described in any one of Examples 6-9, wherein the deployment member defines a lumen, the lumen being configured to transport fluid between at least a proximal end portion of the shaft and a distal-most portion of the tip section. 11. A catheter described in any one of Examples 6-10, wherein the deployment member defines a lumen and includes a plurality of holes configured to radially distribute fluid from within the expandable portion toward the inner surface of the expandable portion, the plurality of holes being configured to radially distribute fluid from within the expandable portion toward the inner surface of the expandable portion. 12. A catheter described in any one of Examples 6-11, wherein the deployment member includes at least one ring electrode, and the at least one ring electrode is positioned on a portion of the deployment member between the distal end portion of the shaft and the distal-most portion of the tip section. 13. the expandable portion is pear-shaped or onion-shaped and includes an insulating neck portion and an actuating body portion distal to the insulating neck portion; the working body portion includes a modular electrode; The insulating neck portion is mechanically coupled to the distal end portion of the shaft. A catheter according to any one of Examples 1-12. 14. the expandable portion further includes a nose portion distal to the working body portion and the insulating neck portion; the nose portion is mechanically coupled to a distal-most portion of the tip section; The catheter described in Example 13. 15. A catheter described in any one of Examples 1-14, wherein the mesh electrode panels each include at least one small hole, and at least one fastener holds adjacent mesh electrode panels of the expandable portion together via corresponding small holes. 16. A catheter as described in Example 15, wherein at least one fastener includes at least one sensor and / or at least one sensor includes at least one electrode and / or temperature measuring device. 17. A catheter as described in example 16, wherein at least one pore of each of the mesh electrode panels is directly connected to at least one strut, and the at least one strut includes a bend such that when adjacent mesh electrode panels are held together via at least one fastener, the at least one sensor is recessed relative to the exterior of the expandable portion. 18. A catheter as described in Example 16 or Example 17, wherein an electrical lead extends into the shaft from at least one sensor within the interior of the expandable portion, and the sensor is formed by and / or positioned on the electrical lead within the interior of the expandable portion. 19. A catheter described in any one of Examples 1-18, further comprising a displacement measuring device configured to measure the displacement of a deployment member mechanically coupled to the expandable portion and determine a shape of the expandable portion. 20. The catheter of any one of Examples 1-19, further comprising a shaft electrode mounted on a distal end portion of the shaft. 21. A catheter described in any one of Examples 1-20, wherein the mesh electrode panels of the expandable portion are electrically isolated from one another such that electrical energy can be delivered from one of the mesh electrode panels independently from other of the mesh electrode panels. twenty two. each of the mesh electrode panels includes a key portion at a proximal end and / or a distal end of the mesh electrode panel; the key portion is configured to mate with a first fitting at a distal end portion of the shaft and / or with a second fitting at a distal-most portion of the tip section; the key portion and the first coupler and / or the second coupler are configured to mechanically couple the mesh electrode panel to a distal end portion of the shaft and / or to a distal-most portion of the tip section. A catheter according to any one of Examples 1-21. 23. At least one of the mesh electrode panels is a first strut mechanically coupled to the deployment member at a distal-most portion of the tip section; a second strut coupled to the first strut at a distal-most portion of the second strut; a third strut coupled to the first strut at a distal-most portion of the third strut; The catheter of any one of Examples 1-22, comprising: twenty four. each of the mesh electrode panels includes at least one strut mechanically coupled to a deployment member at a distal-most portion of the tip section; At least one strut of each of the mesh electrode panels emerges distally from a distal-most portion of the tip section. A catheter described in any one of Examples 1-23. 25. At least one of the mesh electrode panels is a first strut mechanically coupled to a distal end portion of the shaft; a second strut coupled to the first strut at a proximal-most portion of the second strut; a third strut coupled to the first strut at a proximal-most portion of the third strut; The catheter of any one of embodiments 1-24, comprising: 26. A catheter described in any one of Examples 1-25, wherein at least one mesh electrode panel includes a proximal portion, a distal portion, and an intermediate portion between the proximal and distal portions, the intermediate portion being wider than the proximal and distal portions. 27. Each of the mesh electrode panels comprises a plurality of posts; a first subset of the plurality of struts defining a plurality of cells of the expandable portion; the expandable portion includes a distal section, a proximal section, and an equator between the distal and proximal sections; the expandable portion includes a greater number of the plurality of cells around the equator than around the distal segment and / or around the proximal segment; A catheter according to any one of Examples 1-26. 28. Each of the mesh electrode panels comprises a plurality of posts; a first subset of the plurality of struts defining a plurality of cells of the expandable portion; At least one cell of the plurality of cells is formed by (i) a first strut of a first subset of a first mesh electrode panel of the mesh electrode panels and (ii) a second strut of the first subset of a second mesh electrode panel of the mesh electrode panels different from the first mesh electrode panel. A catheter described in any one of Examples 1-27. 29. Each of the mesh electrode panels comprises a plurality of posts; a first subset of the plurality of struts defining a plurality of cells of the expandable portion; a distal-most cell of the plurality of cells is formed by (i) a first strut of a first subset of a first mesh electrode panel of the mesh electrode panels and (ii) a second strut of the first subset of a second mesh electrode panel of the mesh electrode panels that is different from the first mesh electrode panel; A catheter described in any one of Examples 1-28. 30. Each of the mesh electrode panels comprises a plurality of posts; a first subset of the plurality of struts defining a plurality of cells of the expandable portion; a most proximal cell of the plurality of cells is formed by (i) a first strut of a first subset of a first mesh electrode panel of the mesh electrode panels and (ii) a second strut of the first subset of a second mesh electrode panel of the mesh electrode panels different from the first mesh electrode panel; A catheter described in any one of Examples 1-29. 31. Each of the electrode panels comprises a plurality of posts; the plurality of struts includes (i) a first subset of struts having one or more first lengths and / or one or more first widths, and (ii) a second subset of struts having one or more second lengths that are shorter than the one or more first lengths and / or one or more second widths that are narrower than the one or more first widths; The first subset of struts includes a distal-most strut of the plurality of struts and / or a proximal-most strut of the plurality of struts. A catheter according to any one of Examples 1-30. 32. Each of the mesh electrode panels comprises a plurality of posts; The plurality of struts define a plurality of cells in the expandable portion; At least one cell of the plurality of cells is formed by at least four struts. A catheter according to any one of Examples 1-31. 33. At least one mesh electrode panel comprises a plurality of struts; a proximal strut of the plurality of struts includes a first portion having a first width and a second portion having a second width narrower than the first width; A catheter according to any one of Examples 1-32. 34. A catheter described in any one of Examples 1-33, wherein the tip section further comprises at least one localization coil sensor configured to measure position and / or orientation information of the tip section. 35. A catheter described in any one of Examples 1-34, wherein the expandable portion, in the absence of an external force, exhibits an expanded state having a diameter greater than the maximum diameter of the shaft. 36. A method of treating target tissue at a treatment site within a patient using a tip section of a catheter, comprising: determining an effective surface area of ​​a tip section of the catheter, the tip section including a plurality of mesh electrode panels that are electrically insulated from one another and that together define an expandable portion of the tip section; delivering energy to the target tissue at the treatment site; wherein energy is delivered via at least one mesh electrode panel of the expandable portion based at least in part on the determined effective surface area. 37. The method of example 36, wherein determining the effective surface area includes determining a position and / or orientation of the tip segment. 38. Determining the position and / or orientation of the tip segment includes: Visualizing the tip section under fluoroscopy, and / or receiving at least one signal from a localization coil sensor of the tip section, the at least one signal indicative of a position of the localization coil sensor in three-dimensional space and / or indicative of a pitch, yaw, and / or roll of the localization coil sensor; The method of Example 37, comprising: 39. The method of any one of Examples 36-37, wherein delivering energy to the at least one mesh electrode panel of the expandable portion includes delivering energy to the at least one mesh electrode panel based at least in part on a location of the at least one mesh electrode panel within the patient's anatomy. 40. The method of any one of examples 36-39, wherein determining the effective surface area includes determining the degree of deployment and / or deformation of the expandable portion. 41. Determining the degree of deployment and / or deformation of the expandable portion comprises: Visualizing the tip section under fluoroscopy, and / or receiving one or more signals from two or more electrodes carried on the expandable portion, the one or more signals indicative of an impedance between the two or more electrodes; The method of Example 40, comprising: 42. The method of any one of Examples 36-41, wherein determining the effective surface area includes determining the degree of contact between at least one mesh electrode panel and the tissue. 43. The method of any one of Examples 36-42, wherein delivering energy to at least one mesh electrode panel of the expandable portion comprises delivering a defined amount of energy to the at least one mesh electrode panel to achieve a target current density of energy delivered through the at least one mesh electrode panel to tissue in contact with the at least one mesh electrode panel. 44. The method of any one of Examples 36-43, wherein delivering energy to at least one mesh electrode panel includes delivering energy to all of the mesh electrode panels of the expandable portion. 45. The method of example 44, wherein delivering energy to all of the mesh electrode panels of the expandable portion includes separately and sequentially delivering energy to each mesh electrode panel of the expandable portion. 46. ​​The method of example 44, wherein delivering energy to all of the mesh electrode panels of the expandable portion comprises separately and sequentially delivering energy to subgroups of the mesh electrode panels of the expandable portion. 47. The method of any one of Examples 36-43, wherein the at least one mesh electrode panel comprises a subset of the mesh electrode panels of the expandable portion, the subset comprising fewer than all of the mesh electrode panels of the expandable portion, and further wherein delivering energy to the at least one mesh electrode panel comprises delivering energy to only the mesh electrode panels of the subset. 48. The method of any one of Examples 36-47, wherein delivering energy to the at least one mesh electrode panel comprises delivering radio frequency (RF) energy and / or pulsed magnetic field energy to the at least one mesh electrode panel. 49. receiving one or more signals from one or more temperature measuring devices mounted on the expandable portion, the one or more signals indicative of a temperature of tissue in contact with the at least one mesh electrode panel; adjusting energy delivered to the at least one mesh electrode panel based at least in part on the received one or more temperature signals; and / or Delivering irrigation fluid to tissue in contact with the at least one mesh electrode panel. The method of any one of Examples 36-48, further comprising: 50. An electrode panel for use in forming an expandable portion of a tip section of a catheter, comprising: a first section at a proximal end portion of the electrode panel; a second section at a distal end portion of the electrode panel; an actuating section between the first section and the second section; An electrode panel comprising: 51. The electrode panel of example 50, wherein the first section is insulated. 52. The electrode panel of example 50 or example 51, wherein at least a portion of the second section is insulated. 53. The actuation section includes a plurality of struts; The plurality of struts defines a plurality of cells; An electrode panel described in any one of Examples 50-52. 54. The electrode panel of Example 53, wherein the plurality of cells at least partially define an open area of ​​the electrode panel, and wherein fluid, blood, or a combination thereof can flow through the open area. 55. An electrode panel as described in Example 53 or Example 54, wherein at least one cell of the plurality of cells is defined by at least four pillars of the plurality of pillars. 56. The actuation section includes a plurality of struts; the first section includes at least one strut; At least one strut of the first section has a first length and / or a first width; A strut of the plurality of struts has a second length that is less than the first length and / or a second width that is less than the first width. An electrode panel described in any one of Examples 50-55. 57. The actuation section includes a plurality of struts; the second section includes at least one strut; At least one strut of the second section has a first length and / or a first width; A strut of the plurality of struts has a second length that is less than the first length and / or a second width that is less than the first width. An electrode panel described in any one of Examples 50-56. 58. the first section includes at least one strut; At least one strut includes a first portion having a first width and a second portion having a second width narrower than the first width. An electrode panel described in any one of Examples 50-57. 59. The electrode panel of any one of examples 50-58, wherein the working section is wider than the first section. 60. The electrode panel of any one of examples 50-59, wherein the working section is wider than the second section. 61. The electrode panel of any one of examples 50-60, wherein the first section includes a single post. 62. The first section includes a single strut; the actuation section includes a first strut, the first strut being directly coupled to a single strut at a proximal-most portion of the first strut; the working section further includes a second strut, the second strut being directly coupled to the single strut at a proximal-most portion of the second strut; An electrode panel described in any one of Examples 50-61. 63. The first section includes a single strut; the actuation section includes a first strut, the first strut being directly coupled to the single strut at a distal end of the single strut; the actuation section includes a second strut, the second strut being directly coupled to the single strut at a distal end of the single strut; An electrode panel described in any one of Examples 50-62. 64. The electrode panel of any one of examples 50-63, wherein the second section includes a single post. 65. The second section includes a single strut; the actuation section includes a first strut, the first strut being directly coupled to a single strut at a distal-most portion of the first strut; The actuation section further includes a second strut, the second strut being directly coupled to the single strut at a distal-most portion of the second strut. An electrode panel described in any one of Examples 50-64. 66. The second section includes a single strut; the actuation section includes a first strut, the first strut being directly coupled to the single strut at a proximal end of the single strut; the actuation section includes a second strut, the second strut being directly coupled to the single strut at a proximal end of the single strut; An electrode panel described in any one of Examples 50-65. 67. An electrode panel described in any one of Examples 50-66, wherein the second section includes at least one strut, and a strut of the at least one strut is configured to be mechanically coupled to the distal-most portion of the tip section of the catheter. 68. An electrode panel as described in Example 67, wherein a strut of at least one strut is configured to emerge distally from the distal-most portion of the tip section when mechanically coupled to the distal-most portion of the tip section. 69. the electrode panel includes a key portion at a distal end of the electrode panel; the key portion is configured to mate with a coupling at a distal-most portion of the catheter tip section; the key portion and the coupler are configured to mechanically couple the electrode panel to the distal-most portion of the tip section; An electrode panel described in any one of Examples 50-68. 70. An electrode panel described in any one of Examples 50-69, wherein the first section includes at least one strut, and a strut of the at least one strut is configured to be mechanically coupled to a distal end portion of the catheter shaft. 71. the electrode panel includes a key portion at a proximal end of the electrode panel; the key portion is configured to mate with a fitting at a distal end portion of the catheter shaft; the key portion and the coupling are configured to mechanically couple the electrode panel to the distal end portion of the catheter shaft; An electrode panel described in any one of Examples 50-70. 72. An electrode panel described in any one of Examples 50-71, further comprising at least one small hole configured to receive a fastener such that the electrode panel can be mechanically coupled to another electrode panel. 73. The actuation section includes a plurality of struts; At least one of the pores is directly connected to at least one strut of the plurality of struts. The electrode panel described in Example 72. 74. An electrode panel as described in Example 73, wherein at least one strut includes a bend such that the small hole is not coplanar with other struts of the plurality of struts. 75. The electrode panel of any one of examples 50-74, wherein the second section is not insulated.

[0149] D. Conclusion The above detailed description of the embodiments of the present technology is not intended to be exhaustive or to limit the present technology to the precise form disclosed above. Although specific embodiments of the present technology, and examples thereof, are described above for illustrative purposes, various equivalent modifications are also possible within the scope of the present technology, as those skilled in the art will recognize. For example, although steps are presented in a given order, alternative embodiments may perform steps in a different order. Furthermore, the various embodiments described herein can also be combined to provide further embodiments.

[0150] The systems and methods described herein can be provided in the form of a tangible and non-transitory machine-readable medium or media (such as a hard disk drive, hardware memory, etc.) having instructions recorded thereon for execution by a processor or computer. The set of instructions can include various commands that instruct the computer or processor to perform specific operations, such as the methods and processes of the various embodiments described herein. The set of instructions can be in the form of a software program or application. Computer storage media can include volatile and non-volatile media, as well as removable and non-removable media, for storage of information, such as computer-readable instructions, data structures, program modules, or other data. Computer storage media can include, but are not limited to, RAM, ROM, EPROM, EEPROM, flash memory or other solid-state memory technology, CD-ROM, DVD, or other optical storage, magnetic disk storage, or any other hardware medium that can be used to store desired information and that can be accessed by the components of the system. The components of the system can communicate with each other via wired or wireless communication. The components can be separate from one another, or various combinations of components can be integrated together in a monitor or processor, or contained within a workstation with standard computer hardware (e.g., processors, circuitry, logic circuits, memory, and the like). The system can include processing devices such as microprocessors, microcontrollers, integrated circuits, control units, storage media, and other hardware.

[0151] From the foregoing, it should be understood that, although specific embodiments of the present technology are described herein for illustrative purposes, well-known structures and functions have not been shown or described in detail to avoid unnecessarily obscuring the description of the embodiments of the present technology. To the extent that any material incorporated herein by reference is inconsistent with the present disclosure, the present disclosure shall control. Where the context permits, singular or plural terms may also include the plural or singular terms, respectively. Also, unless the word "or" is expressly limited with reference to a list of two or more items to mean only a single item exclusively from the other items, the use of "or" in such a list shall be interpreted to include (a) any single item in the list, (b) all of the items in the list, or (c) any combination of the items in the list. As used herein, the phrase "and / or," such as in "A and / or B," refers to "A alone," "B alone," and "both A and B." Additionally, the terms "comprising," "including," "having," and "with" are used throughout to mean including at least the recited features, so as not to exclude any greater number of the same features and / or other features of additional types. Furthermore, as used herein, the term "substantially" refers to a complete or nearly complete degree or extent of an action, property, quality, state, structure, article, or result. For example, an object that is "substantially" enclosed would mean that the object is either completely enclosed or nearly completely enclosed. The precise acceptable degree of deviation from absolute completeness may depend on the specific context in some cases. Generally speaking, however, the approximation of completeness will be such that one has the same overall result as if absolute and complete completion were obtained. The use of "substantially" is equally applicable when used in a negative sense, such as referring to a complete or nearly complete lack of an action, property, quality, state, structure, article, or result.

[0152] From the foregoing, it should also be understood that various modifications may be made without departing from the present technology. For example, various components of the present technology may be further divided into subcomponents, or various components and functions of the present technology may be combined and / or integrated. Furthermore, although advantages associated with certain embodiments of the present technology are described in the context of those embodiments, other embodiments may also exhibit such advantages, and not all embodiments necessarily exhibit such advantages to be within the scope of the present technology. Thus, the present disclosure and associated technology may encompass other embodiments not expressly shown and described herein.

Claims

1. A catheter comprising: a shaft having a proximal end portion and a distal end portion; a tip section mechanically coupled to the distal end portion of the shaft, the tip section including a plurality of mesh electrode panels that together define an expandable portion; Equipped with A catheter, wherein each of the plurality of mesh electrode panels includes at least one small aperture, and at least one fastener holds adjacent mesh electrode panels of the expandable portion together via a corresponding small aperture.

2. 2. The catheter of claim 1, wherein each of the plurality of mesh electrode panels comprises: (i) first and second insulating portions axially distributed along the mesh electrode panel; and (ii) an active portion between the first and second insulating portions.

3. 10. The catheter of claim 1, wherein each of the plurality of mesh electrode panels comprises: (i) a first insulating portion; and (ii) an active portion distal to the first insulating portion.

4. The catheter of claim 1 , wherein each of the plurality of mesh electrode panels comprises a plurality of struts, a first subset of the plurality of struts defining a plurality of cells.

5. The catheter of claim 4 , wherein the plurality of cells at least partially define an open area of ​​the expandable portion through which fluid, blood, or a combination thereof can flow.

6. 2. The catheter of claim 1, wherein the tip section further comprises a deployment member mechanically coupled to the expandable portion at a distal-most portion of the tip section, the expandable portion encasing at least a portion of the deployment member between the distal end portion of the shaft and the distal-most portion of the tip section.

7. The catheter of claim 6 , wherein the deployment member is telescopic.

8. 7. The catheter of claim 6, wherein the expandable portion is configured to expand and compress via proximal and distal movement, respectively, of the deployment member along an axis defined by the shaft.

9. The catheter of claim 6 , wherein the deployment member defines a lumen configured to receive a guidewire.

10. 7. The catheter of claim 6, wherein the deployment member defines a lumen configured to transport fluid between at least the proximal end portion of the shaft and the distal-most portion of the tip section.

11. 7. The catheter of claim 6, wherein the deployment member defines a lumen, the deployment member including a plurality of holes, the plurality of holes configured to distribute fluid radially from within the expandable portion toward an inner surface of the expandable portion.

12. A catheter, comprising: a shaft having a proximal end portion and a distal end portion; a tip section mechanically coupled to the distal end portion of the shaft, the tip section including a plurality of mesh electrode panels that together define an expandable portion; Equipped with the tip section further comprises a deployment member mechanically coupled to the expandable portion at a distal-most portion of the tip section, the expandable portion encasing at least a portion of the deployment member between the distal end portion of the shaft and the distal-most portion of the tip section; A catheter, wherein the deployment member includes at least one ring electrode, the at least one ring electrode being positioned on the portion of the deployment member between the distal end portion of the shaft and the distal-most portion of the tip section.

13. the expandable portion is pear-shaped or onion-shaped, the expandable portion including an insulating neck portion and an actuating body portion distal to the insulating neck portion; the actuating body portion includes a modular electrode; The catheter of claim 1 , wherein the insulating neck portion is mechanically coupled to the distal end portion of the shaft.

14. the expandable portion further includes a nose portion distal to the actuating body portion and the insulating neck portion; The catheter of claim 13 , wherein the nose portion is mechanically coupled to a distal-most portion of the tip section.

15. The catheter of claim 1 , 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.

16. 16. The catheter of claim 15, wherein the at least one pore of each of the plurality of mesh electrode panels is directly connected to at least one strut, the at least one strut including a bend such that the at least one sensor is recessed relative to an exterior of the expandable portion when the adjacent mesh electrode panels are held together via the at least one fastener.

17. 16. The catheter of claim 15, wherein an electrical lead extends from the at least one sensor within the expandable portion into the shaft, and a sensor is formed by and / or positioned on the electrical lead within the expandable portion.

18. A catheter comprising: a shaft having a proximal end portion and a distal end portion; a tip section mechanically coupled to the distal end portion of the shaft, the tip section including a plurality of mesh electrode panels that together define an expandable portion; Equipped with The catheter further comprises a displacement measuring device configured to determine a shape of the expandable portion by measuring the displacement of a deployment member mechanically coupled to the expandable portion.

19. A catheter comprising: a shaft having a proximal end portion and a distal end portion; a tip section mechanically coupled to the distal end portion of the shaft, the tip section including a plurality of mesh electrode panels that together define an expandable portion; Equipped with The catheter further comprises a shaft electrode mounted on the distal end portion of the shaft.

20. 2. The catheter of claim 1, wherein the mesh electrode panels of the expandable portion are electrically isolated from one another such that electrical energy can be delivered from any one mesh electrode panel of the plurality of mesh electrode panels independently from other mesh electrode panels of the plurality of mesh electrode panels.

21. each of the plurality of mesh electrode panels includes a key portion at a proximal and / or distal end of the mesh electrode panel; the key portion is configured to mate with a first fitting at the distal end portion of the shaft and / or with a second fitting at a distal-most portion of the tip section; 2. The catheter of claim 1, wherein the key portion and the first coupler and / or the second coupler are configured to mechanically couple the plurality of mesh electrode panels to the distal end portion of the shaft and / or to mechanically couple the plurality of mesh electrode panels to the distal-most portion of the tip section.

22. At least one mesh electrode panel a first strut mechanically coupled to a deployment member at a distal-most portion of the tip section; a second strut coupled to the first strut at a distal-most portion of the second strut; a third strut coupled to the first strut at a distal-most portion of the third strut; The catheter of claim 1 ,

23. each of the plurality of mesh electrode panels includes at least one strut mechanically coupled to a deployment member at a distal-most portion of the tip section; The catheter of claim 1 , wherein the at least one strut of each of the plurality of mesh electrode panels emerges distally from the distal-most portion of the tip section.

24. At least one of the mesh electrode panels comprises: a first strut mechanically coupled to the distal end portion of the shaft; a second strut coupled to the first strut at a proximal-most portion of the second strut; a third strut coupled to the first strut at a proximal-most portion of the third strut; The catheter of claim 1 ,

25. 10. The catheter of claim 1, wherein at least one mesh electrode panel includes a proximal portion, a distal portion, and an intermediate portion between the proximal and distal portions, the intermediate portion being wider than the proximal and distal portions.

26. Each of the plurality of mesh electrode panels comprises a plurality of struts; a first subset of the plurality of struts defining a plurality of cells of the expandable portion; the expandable portion includes a distal section, a proximal section, and an equator between the distal section and the proximal section; The catheter of claim 1 , wherein the expandable portion includes a greater number of the plurality of cells around the equator than around the distal section and / or around the proximal section.

27. Each of the plurality of mesh electrode panels comprises a plurality of struts; a first subset of the plurality of struts defining a plurality of cells of the expandable portion; 2. The catheter of claim 1, wherein at least one cell of the plurality of cells is formed by (i) a first strut of the first subset that belongs to a first mesh electrode panel of the plurality of mesh electrode panels and (ii) a second strut of the first subset that belongs to a second mesh electrode panel, different from the first mesh electrode panel of the plurality of mesh electrode panels.

28. Each of the plurality of mesh electrode panels comprises a plurality of struts; a first subset of the plurality of struts defining a plurality of cells of the expandable portion; 2. The catheter of claim 1, wherein a distal-most cell of the plurality of cells is formed by (i) a first strut of the first subset that belongs to a first mesh electrode panel of the plurality of mesh electrode panels and (ii) a second strut of the first subset that belongs to a second mesh electrode panel, different from the first mesh electrode panel of the plurality of mesh electrode panels.

29. Each of the plurality of mesh electrode panels comprises a plurality of struts; a first subset of the plurality of struts defining a plurality of cells of the expandable portion; 2. The catheter of claim 1, wherein a most proximal cell of the plurality of cells is formed by (i) a first strut of the first subset that belongs to a first mesh electrode panel of the plurality of mesh electrode panels and (ii) a second strut of the first subset that belongs to a second mesh electrode panel different from the first mesh electrode panel of the plurality of mesh electrode panels.

30. Each of the plurality of mesh electrode panels comprises a plurality of struts; the plurality of struts includes (i) a first subset of struts having one or more first lengths and / or one or more first widths, and (ii) a second subset of struts having one or more second lengths that are shorter than the one or more first lengths and / or one or more second widths that are narrower than the one or more first widths; The catheter of claim 1 , wherein the first subset of struts includes a distal-most strut of the plurality of struts and / or a proximal-most strut of the plurality of struts.

31. A catheter comprising: a shaft having a proximal end portion and a distal end portion; a tip section mechanically coupled to the distal end portion of the shaft, the tip section including a plurality of mesh electrode panels that together define an expandable portion; Equipped with Each of the plurality of mesh electrode panels comprises a plurality of struts; the plurality of struts defining a plurality of cells in the expandable portion; A catheter, wherein at least one cell of the plurality of cells is formed by at least four struts.

32. A catheter comprising: a shaft having a proximal end portion and a distal end portion; a tip section mechanically coupled to the distal end portion of the shaft, the tip section including a plurality of mesh electrode panels that together define an expandable portion; Equipped with At least one mesh electrode panel comprises a plurality of struts; A catheter, wherein a proximal strut of the plurality of struts includes a first portion having a first width and a second portion having a second width narrower than the first width.

33. The catheter of claim 1 , wherein the tip section further comprises at least one localization coil sensor configured to measure position information and / or attitude information of the tip section.

34. The catheter of claim 1 , wherein the expandable portion, in the absence of an external force, exhibits a deployed state having a diameter greater than a maximum diameter of the shaft.

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