High density electrode catheter with magnetic position tracking

Abstract

Various embodiments of the present disclosure may include high density electrode catheters. In some embodiments, a high density electrode catheter may include a catheter shaft including a proximal end and a distal end, the catheter shaft defining a catheter shaft longitudinal axis. In some embodiments, a high density electrode catheter may include a shaft magnetic position sensor disposed along a distal portion of a catheter shaft. In some embodiments, a high density electrode catheter may include a flexible tip portion positioned adjacent a distal end of a catheter shaft, where the flexible tip portion includes a flexible frame. In some embodiments, a high density electrode catheter may include a plurality of electrodes disposed on a flexible frame. In some embodiments, the high density electrode catheter may include a tip magnetic position sensor disposed on a portion of the flexible frame.

Description

[0001] This application is a divisional application of Chinese patent application No. 202180050243.4, filed on August 18, 2021, entitled "High-Density Electrode Conduit with Magnetic Position Tracking".

[0002] Priority Statement

[0003] This application claims priority to U.S. Provisional Patent Application No. 63 / 067,284, filed August 18, 2020, which is incorporated herein by reference as if fully set forth herein. Technical Field

[0004] This disclosure relates to a high-density electrode conduit with magnetic position tracking. Background Technology

[0005] Catheters have been used in cardiac medical procedures for many years. For example, catheters can be placed in specific locations within the body that would otherwise be inaccessible without more invasive procedures.

[0006] Traditional mapping catheters may include, for example, multiple adjacent loop electrodes surrounding the longitudinal axis of the catheter, which may be made of platinum or some other metal. These loop electrodes are relatively rigid. Similarly, traditional ablation catheters may include relatively rigid tip electrodes for delivering treatment (e.g., delivering RF ablation energy) and may also include multiple adjacent loop electrodes. When using these traditional catheters and their relatively rigid (or non-compliant) metallic electrodes, especially in the presence of sharp gradients and undulations, maintaining good electrical contact with cardiac tissue can be difficult.

[0007] Whether mapping or creating damage in the heart, the heart's beating, especially unstable or irregular beatings, complicates matters, making it difficult to maintain adequate contact between the electrode and tissue for a sufficient duration. These problems are exacerbated on contoured or trabecular surfaces. Without adequate contact between the electrode and tissue, high-quality damage or accurate mapping is impossible.

[0008] The above discussion is for illustrative purposes only and should not be construed as a denial of the scope of the claims. Summary of the Invention

[0009] Various embodiments of this disclosure may include high-density electrode catheters. In some embodiments, the high-density electrode catheter may include a catheter shaft including a proximal end and a distal end, the catheter shaft defining a longitudinal axis. In some embodiments, the high-density electrode catheter may include an axial magnetic position sensor disposed along a distal portion of the catheter shaft. In some embodiments, the high-density electrode catheter may include a flexible tip portion positioned distally adjacent to the catheter shaft, wherein the flexible tip portion includes a flexible frame. In some embodiments, the high-density electrode catheter may include a plurality of electrodes disposed on the flexible frame. In some embodiments, the high-density electrode catheter may include a tip magnetic position sensor disposed on a portion of the flexible frame.

[0010] Various embodiments of this disclosure may include high-density electrode catheters. In some embodiments, the high-density electrode catheter may include a catheter shaft including a proximal end and a distal end, the catheter shaft defining a longitudinal axis. In some embodiments, the high-density electrode catheter may include a flexible tip portion positioned distally adjacent to the catheter shaft, wherein the flexible tip portion includes a flexible frame including a longitudinally extending first lateral arm, a second lateral arm, and a central arm. In some embodiments, the high-density electrode catheter may include a plurality of electrodes disposed on each of the first lateral arm, the second lateral arm, and the central arm. In some embodiments, the high-density electrode catheter may include a tip magnetic position sensor disposed on a distal portion of the central arm.

[0011] Various embodiments of this disclosure may include high-density electrode catheters. In some embodiments, the high-density electrode catheter may include a catheter shaft including a proximal end and a distal end, the catheter shaft defining a longitudinal axis. In some embodiments, the high-density electrode catheter may include a flexible tip portion positioned distally adjacent to the catheter shaft, wherein the flexible tip portion includes a flexible frame. In some embodiments, the high-density electrode catheter may include flexible circuitry disposed on the flexible frame, wherein the flexible circuitry includes a plurality of electrodes disposed thereon. In some embodiments, the high-density electrode catheter may include a tip magnetic position sensor disposed on a portion of the flexible frame. Attached Figure Description

[0012] Figure 1A This is a schematic diagram of a catheter system according to an embodiment of the present disclosure.

[0013] Figure 1B This is a schematic block diagram of an electroporation treatment system according to an embodiment of the present disclosure.

[0014] Figure 2A This is a top view of a high-density electrode conduit according to various embodiments of the present disclosure, and Figure 2B These are isometric side and top views of high-density electrode conduits according to various embodiments of the present disclosure.

[0015] Figure 3A These are isometric side and top views of high-density electrode conduits according to various embodiments of the present disclosure, and Figure 3B This is a bottom view of a high-density electrode conduit according to various embodiments of the present disclosure.

[0016] Figure 3C According to embodiments of this disclosure Figure 3A and Figure 3B The side view of the high-density electrode conduit depicted in the image.

[0017] Figure 3D According to embodiments of this disclosure Figures 3A to 3C Isometric side and bottom views of the high-density electrode conduit depicted in the figure.

[0018] Figure 3E According to embodiments of this disclosure Figures 3A to 3D The image depicts isometric top and side views of a high-density electrode conduit, with further depiction of the manifold portion.

[0019] Figure 3F According to embodiments of this disclosure Figures 3A to 3E Isometric bottom and side views of the high-density electrode conduit depicted in the figure, further depicting... Figure 3E The manifold section.

[0020] Figure 3G According to embodiments of this disclosure Figures 3A to 3F The image depicts isometric top and side views of a high-density electrode conduit, with further details of the mounting portion.

[0021] Figure 3H According to embodiments of this disclosure Figures 3A to 3G Isometric bottom and side views of the high-density electrode conduit depicted in the figure, further depicting... Figure 3G The installation part.

[0022] Figure 3I These are isometric top and side views of a flexible underlayer structure of a high-density electrode conduit depicted herein according to embodiments of the present disclosure.

[0023] Figure 3J According to embodiments of this disclosure Figures 3A to 3I Isometric bottom and side views of the flexible underlying structure of the high-density electrode conduit depicted in the figure.

[0024] Figure 3K This is a cross-sectional view of a dual-lumen tube according to an embodiment of the present disclosure.

[0025] Figure 3L According to embodiments of this disclosure Figure 3H The image depicts isometric bottom and side views of a high-density electrode conduit, where the conduit does not cover the flexible underlying structure.

[0026] Figure 3M According to embodiments of this disclosure Figure 3G and Figure 3H Isometric near-end view of the mounting portion depicted in the figure.

[0027] Figure 3N These are isometric bottom and side views of the near end of a flexible substructure according to embodiments of the present disclosure.

[0028] Figure 3O This is a bottom view of the near end of a flexible substructure according to an embodiment of the present disclosure.

[0029] Figure 3P This is a bottom view of the proximal end of a flexible substructure disposed in the mounting portion, depicted in cross-sectional view according to an embodiment of the present disclosure.

[0030] Figure 3Q This is an isometric far-end view of the connecting rod portion according to an embodiment of the present disclosure.

[0031] Figure 3R According to embodiments of this disclosure Figure 3G The isometric near-end view of the connecting rod portion depicted in the figure.

[0032] Figure 3S According to embodiments of this disclosure Figure 3J The bottom view of the distal portion of the flexible substructure depicted in the image shows the addition of electrodes, distal lateral substructure channels, and non-invasive tips.

[0033] Figure 3T According to embodiments of this disclosure Figure 3J The image depicts a bottom isometric view of the distal portion of the flexible substructure, with added electrodes, distal inner substructure channels, and non-invasive tips.

[0034] Figure 3U According to embodiments of this disclosure Figure 3J The image depicts a bottom isometric view of the distal portion of the flexible substructure, without the distal coupling and magnetic position sensor mount.

[0035] Figure 4 This is a top view of a high-density electrode conduit with a flexible tip portion according to an embodiment of the present disclosure, the flexible tip portion having a pair of magnetic position sensors disposed on a distal portion of the flexible tip portion.

[0036] Figure 5A This is an isometric view of a high-density electrode conduit including six longitudinally extending arms, according to an embodiment of the present disclosure.

[0037] Figure 5B It is an embodiment of the present disclosure including six longitudinally extending arms. Figure 5A Isometric view of the high-density electrode conduit facing the distal end, as depicted in the image.

[0038] Figure 5C According to embodiments of this disclosure Figure 5A The high-density electrode conduit, further illustrated with the distal end of the proximal coupling and the frame mounting portion.

[0039] Figure 5D According to embodiments of this disclosure Figure 5A Side view of a high-density electrode conduit.

[0040] Figure 6A This is an isometric view of the lower structure of the flexible tip of a high-density electrode conduit according to an embodiment of the present disclosure.

[0041] Figure 6B According to embodiments of this disclosure Figure 6A The near-end view of the mounting portion depicted in the figure.

[0042] Figure 7 It is the distal flexible tip portion of a high-density electrode conduit with a specific electrode configuration according to an embodiment of the present disclosure.

[0043] Figures 8A to 8E Various electrode spacing configurations of electrodes disposed on the distal flexible tip portion of a high-density electrode conduit according to embodiments of the present disclosure are depicted.

[0044] Figure 9 This is an isometric rear view of a distal tip assembly including a magnetic position sensor mount and a distal coupling member according to an embodiment of the present disclosure.

[0045] Figure 10 This is a side view of a distal tip assembly including a magnetic position sensor mount and a distal coupling member according to an embodiment of the present disclosure.

[0046] Figure 11 This is a top view of a high-density electrode conduit with interlaced electrodes according to an embodiment of the present disclosure.

[0047] Figure 12A This is a top view of the lower structure of the flexible tip of a high-density electrode conduit according to an embodiment of the present disclosure, including a magnetic position sensor located in an outer frame.

[0048] Figure 12B According to embodiments of this disclosure Figure 12AThe image shows a close-up view of the lower structure of the flexible tip of the high-density electrode conduit, further depicting a magnetic position sensor within the outer frame.

[0049] Figure 13A This is a top view of the lower structure of the flexible tip of a high-density electrode conduit according to an embodiment of the present disclosure, including a magnetic position sensor located in an outer frame.

[0050] Figure 13B According to embodiments of this disclosure Figure 13A The image shows a close-up view of the lower structure of the flexible tip of the high-density electrode conduit, further depicting a magnetic position sensor within the outer frame.

[0051] Figure 14 This is a top view of a high-density electrode conduit according to an embodiment of the present disclosure, wherein a magnetic position sensor is provided in the outer arm of the high-density electrode conduit. Detailed Implementation

[0052] Referring now to the accompanying drawings, in which the same reference numerals are used to identify the same parts in various views, Figure 1A This is a schematic diagram of a catheter system in which the present invention can be practiced. The system may include various visualization, mapping, and navigation components as known in the art, including, for example, EnSite™ Precision, commercially available from Abbott Laboratories. TM Cardiac mapping and visualization systems, as discussed further in this article.

[0053] This system can be used in conjunction with or for various medical procedures, such as cardiac mapping and / or cardiac ablation procedures. In one embodiment, the medical positioning system 14 may include a magnetic field-based system, such as CARTO, which is available from Biosense Webster. ®The system, and as generally indicated with reference to one or more of U.S. Patents Nos. 6,498,944, 6,788,967 and 6,690,963, the entire disclosure of which is incorporated herein as if fully set forth herein. In another embodiment, the magnetic field-based system may include, in part, a magnetic field-based system, such as the MediGuide™ technology system from Abbott Laboratories, and the disclosures thereof, as generally referenced in one or more of the following: U.S. Patent Nos. 6,233,476, 7,197,354, and 7,386,339; U.S. Patent Application No. 14 / 208,120 entitled “Medical Device Navigation System”, filed March 13, 2014; U.S. Provisional Patent Application No. 61 / 834,223 entitled “Medical Device Navigation System”, filed June 12, 2013; and International Application No. PCT / IB2014 / 059709 entitled “Medical Device Navigation System”, filed March 13, 2014, are incorporated herein by reference in their entirety, as if fully set forth herein.

[0054] In yet another embodiment, the medical positioning system 14 may include a combination of magnetic field-based and electric field-based systems, such as, but not limited to, those described in, but not limited to, U.S. Patent Application No. 13 / 231,284, filed September 13, 2011, entitled "Catheter Navigation Using Impedance and Magnetic Field Measurements," and U.S. Patent Application No. 13 / 087,203, filed April 14, 2011, entitled "System and Method for Registration of Multiple Navigation Systems to a Common Coordinate Frame," each of which is incorporated herein by reference in its entirety as if fully set forth herein, or includes CARTO, commercially available from Bernsons Webster. ®3. System. In some embodiments, the medical positioning system 14 may include other commonly used systems or be used in combination with other commonly used systems, such as, but not limited to, systems based on fluorescence microscopy, computed tomography (CT), and magnetic resonance imaging (MRI). For clarity and illustration purposes only, the medical positioning system 14 is described below as including a hybrid magnetic and impedance tracking system. Although reference has been made to cardiac mapping of the heart, one or more aspects of this disclosure may be applied to other anatomical structures.

[0055] refer to Figure 1A The catheter system includes a schematic depiction of the heart 10 of patient 11. The system includes the ability to accommodate multiple catheter positions as the distal end of the catheter sweeps around and inside the chambers of the heart. For this purpose, Figure 1A An exemplary catheter positioning system based on an externally applied orthogonal electric field is shown, which is used to determine the position of one or more catheter position sensors. Such a system may include an impedance positioning system and / or a hybrid magnetic and impedance tracking system, such as the EnSite™ NavX™ electroanatomical mapping system, the EnSite™ Velocity™ electroanatomical mapping system, and the EnSite Precision™ electroanatomical mapping system, all of which are commercially available from Abbott Laboratories or can be found with reference to U.S. Patent No. 7,263,397 ('397 patent) or U.S. Patent No. 2007 / 0060833 A1, U.S. Application No. 11 / 227,580 ('580 application), filed September 15, 2005, or U.S. Application No. 2018 / 0296111 A1, or U.S. Application No. 15 / 953,155 ('155 application), filed April 13, 2018. The '397 patent, '580 application and '155 application are all incorporated herein by reference as if fully described herein.

[0056] Various EnSite™ systems are based on the principle that when an electric current passes through the chest, a pressure drop occurs across an internal organ (e.g., the heart), and this pressure drop can be measured and used to determine the location of a medical device within the body. However, it should be understood that this embodiment is merely exemplary and not limiting in nature. Other techniques for determining the location of a catheter in 3D space (e.g., MediGuide) are also available. TM (Systems) can be used to practice this invention, including, for example, CARTO from Bernsons Webster. ®Navigation and positioning systems, or Northern Digital Inc.'s AURORA® system, both utilize magnetic fields rather than electric fields. Therefore, as used herein, sensors are configured to generate signals indicating the position of the conduit, and these sensors may include one or more position sensors. Position sensors may include, for example, one or more electrodes configured to detect one or more characteristics of an electric field in the case of an impedance-based positioning system, or alternatively, one or more coils (e.g., wire windings) configured to detect one or more characteristics of a magnetic field in the case of a magnetic field-based positioning system.

[0057] It should also be understood that in some positioning systems, one or more position sensors can collectively define the sensor. One or more position sensors can be positioned at the distal end of the catheter, and the positioning system can be configured to obtain position information from one or more position sensors. The positioning system can use not only the received position information but also the geometric relationship between the one or more position sensors providing the position information and the distal position on the catheter (e.g., one piece of geometric information could be the distance from the annular electrode to the tip) to calculate the distal position of the catheter. Finally, the positioning system can use the calculated position as if it were directly collected. Similarly, in a magnetic field-based positioning embodiment, there can be a geometric relationship between the catheter tip and the magnetic coil, where the positioning system is configured to use the calculated tip position (i.e., calculated based on the magnetic coil signal and predefined knowledge of the geometric relationship between the coil and the tip) as if such a position were directly collected. Of course, other variations are possible.

[0058] Continue to refer to Figure 1A In the illustrated embodiment of the impedance-based positioning system, three sets of surface electrodes are shown (e.g., applied via a patch): X-axis electrodes 12, 14; Y-axis electrodes 18, 19; and Z-axis electrodes 16, 22. In some embodiments, an additional surface electrode 21 may be used (e.g., applied via an “abdominal” patch). All surface electrodes are connected to a switch 24. A representative catheter 13 with a single distal electrode 17 is shown, which may be referred to herein as a “roving” or “measuring” electrode. In some embodiments, catheter 13 may be a coronary sinus catheter or a right ventricular apical catheter. In this embodiment, electrode 17 may define a position sensor; however, as mentioned above, many variations are possible, and catheter 13 may include multiple position sensors, as discussed further herein. Figure 1A A second independent catheter 29 with a fixed reference electrode 31 is also shown, which can be fixed to the heart 10 for calibration purposes.

[0059] Figure 1A Further illustrations include a computer system 20, a signal generator 25, an analog-to-digital converter 26, and a low-pass filter 27. The computer system 20 can utilize software, hardware, firmware, and / or logic to perform the various functions described herein. The computing system 20 can be a combination of hardware and instructions to share information. Hardware may include, for example, processing resources 32 and / or memory resources 33 (e.g., a non-transitory computer-readable medium (CRM) database, etc.). Processing resources 32, as used herein, may include multiple processors capable of executing instructions stored in memory resources 33. Processing resources 32 may be integrated in a single device or distributed across multiple devices. Instructions (e.g., computer-readable instructions (CRIs)) may include instructions stored in memory resources 33 and executable by processing resources 32 to align with the heart model.

[0060] Computer system 20 is configured to control signal generator 25 according to a predetermined strategy to selectively energize various surface electrode pairs. In operation, computer system 20 is configured to obtain raw patch data (i.e., voltage readings) via filter 27 and AD converter 26, and use the raw patch data to determine the raw electrode position coordinates in three-dimensional space (X, Y, Z) of the catheter electrode (e.g., the aforementioned circulating electrode 17) located inside the heart 10 or its chambers. In some embodiments, when such electrode position coordinates are received, the phase of the cardiac cycle of patient 11 can be measured or otherwise determined. For this purpose, in embodiments, most or all of the conventional twelve (12) electrocardiogram (ECG) leads are provided to support ECG acquisition of patient 11, which are coupled to the body surface electrodes and are collectively identified by reference numeral 15.

[0061] Alternatively, a reference electrode positioned at a fixed location within the heart 10 (e.g., fixed reference electrode 31) can be used to provide a relatively stable signal that can be analyzed to determine the cardiac phase of the heart 10 during the cardiac cycle (e.g., placed at the coronary sinus). More generally, another catheter with electrodes (a non-mobile or circulating catheter) can be positioned relative to the heart 10 and held in a constant position to obtain a relatively stable signal indicating the cardiac phase. As shown, ECG lead 15 is directly coupled to computer system 20 for acquisition and subsequent processing to obtain the phase of the heart 10 during the cardiac cycle. ECG lead 15 may also be provided to other systems (not shown).

[0062] As previously mentioned, embodiments of this disclosure can be used with magnetic field-based systems. Some embodiments may include a main electronic control unit (e.g., one or more processors) with various input / output mechanisms, a display 23, an optional image database, a positioning system such as a medical positioning system (MPS) (electromagnetic sensor tracking system), an electrocardiogram (ECG) monitor, one or more MPS position sensors (e.g., patient reference sensors), and MPS-enabled medical devices (e.g., elongated catheters or inserters) that themselves include one or more of the MPS position sensors described above.

[0063] As discussed, in some embodiments, the medical positioning system may include a magnetic field-based system, such as the MediGuide™ technology system from Abbott Laboratories, and the disclosures of one or more of the following are generally referenced herein: U.S. Patent Nos. 6,233,476, 7,197,354, and 7,386,339; U.S. Patent No. 14 / 208,120 entitled “Medical Device Navigation System”, filed March 13, 2014; U.S. Provisional Patent Application No. 61 / 834,223 entitled “Medical Device Navigation System”, filed June 12, 2013; and International Application No. PCT / IB2014 / 059709 entitled “Medical Device Navigation System”, filed March 13, 2014, are incorporated herein by reference in their entirety as if fully set forth herein.

[0064] The embodiment may include an input / output mechanism, which may include conventional devices for interface connection with a computer-based control unit, such as a keyboard, mouse, input pad, foot pedal, switch, etc. The embodiment may also include a display 23, which may also include conventional devices.

[0065] The embodiments can be used in navigation applications utilizing imaging of regions of interest. Therefore, the magnetic field-based system may optionally include an image database. The image database can be configured to store image information related to the patient's body, such as regions of interest surrounding a target site of a medical device and / or multiple regions of interest along a navigation path through which the device is expected to reach the target site. The image data in the image database may include known image types, including: (1) one or more two-dimensional static images acquired at various individual times in the past; (2) multiple related two-dimensional images acquired in real time from an image acquisition device (e.g., fluorescence images from an X-ray imaging device), wherein the image database acts as a buffer (real-time fluorescence fluoroscopy); and / or (3) a related two-dimensional image sequence defining image playback (CL), wherein each image in the sequence has at least an associated ECG timing parameter sufficient to allow playback of the sequence based on a real-time ECG signal obtained from an ECG monitor. It should be understood that the foregoing is merely illustrative and not limiting in nature. For example, the image database may also include three-dimensional image data. It should also be understood that images can be acquired using any imaging modality now known or developed in the future (e.g., X-ray, ultrasound, computed tomography, MRI, etc.).

[0066] MPS can be configured as a positioning system to determine positioning (location determination) data relative to one or more of the MPS position sensors, one or more medical devices, and / or one or more patient reference sensors (PRS), and output the corresponding position readings. Position readings may each include at least one or both of position and orientation (P&O) relative to a reference coordinate system (which may be the MPS's coordinate system). For example, P&O can be expressed as the position (i.e., coordinates in the three axes X, Y, and Z) and orientation (i.e., azimuth and elevation) of a magnetic field sensor in a magnetic field relative to a magnetic field generator or transmitter.

[0067] MPS determines various positions (i.e., P&Os) in a reference coordinate system based on captured and processed signals received from magnetic field sensors positioned in a controlled, low-intensity AC magnetic field. From an electromagnetic point of view, these sensors generate voltages induced in coils within a changing magnetic field, as contemplated herein. Therefore, the sensors are configured to detect one or more characteristics of the magnetic field in which they are located and generate an indication signal, which is further processed by the MPS to obtain the corresponding P&O of the sensor. Exemplary design features and manufacturing processes and methods for sensors and medical devices incorporating such sensors can be found in U.S. Patent No. 8,636,718, which is incorporated herein by reference in its entirety.

[0068] The MPS sensor, and optionally an attached MPS sensor in further embodiments, can be associated with an MPS-enabled medical device. Another MPS sensor (i.e., a patient reference sensor (PRS)) is configured to provide a position reference for the patient's body to allow for motion compensation for overall body movement and / or movement caused by breathing. The PRS can be attached to the patient's sternal manubrium, a stable location on the chest, or another relatively stable location. Like the MPS position sensor, the PRS is configured to detect one or more characteristics of the magnetic field in which it is located, wherein the MPS provides position readings (e.g., P&O readings) indicating the PRS's position and orientation in a reference coordinate system.

[0069] An electrocardiogram (ECG) monitor is configured to continuously detect electrical timing signals of the heart organ using multiple ECG electrodes (not shown), which can be externally attached to the patient's body. The timing signals typically correspond to specific phases of the cardiac cycle. Typically, the ECG signals can be used by a control unit for ECG-synchronized playback (image playback) of previously captured image sequences stored in a database. Both the ECG monitor and the ECG electrodes can include conventional components.

[0070] Magnetic field-based systems can be incorporated into or associated with fluorescence imaging systems that may include commercially available fluorescence imaging components, such as X-ray sources, C-arms, and / or X-ray image intensifiers or detectors (i.e., "catheterization labs"). The MPS (Electromagnetic Sensor Tracking System) includes a magnetic emitter assembly (MTA) (electromagnetic field generator) and a magnetic processing core for determining position (P&O) readings. The MTA is configured to generate a magnetic field in and around the patient's chest cavity within a predefined three-dimensional space identified as a motion box.

[0071] As described above, the MPS sensor is configured to sense one or more characteristics of the magnetic field when the sensor is within the motion box, and each generates a corresponding signal provided to the magnetic processing core. The processing core responds to these detected signals and is configured to calculate the corresponding P&O reading for each MPS sensor in the motion box. The processing core can detect when the MPS sensor leaves the motion box. Therefore, MPS enables real-time tracking of each sensor in three-dimensional space.

[0072] The actual volume of the motion box can be stored, for example, in a processing core, which is capable of determining the position and orientation of each sensor relative to the boundaries of the motion box. Alternatively, the actual volume of the motion box can be stored, for example, in a main control unit, which is capable of determining the position and orientation of each sensor relative to the boundaries of the motion box. Therefore, the system can (e.g., in the processing core or in the main control unit) assess whether a sensor is inside the motion box, at the boundaries of the motion box, or outside the motion box. Based on this information, the motion box and sensors can be displayed relative to each other on a display, as described in more detail elsewhere herein.

[0073] In some alternative embodiments, the MTA may be located below the patient examination table, between the X-ray source and the patient examination table. For example, the MTA may be connected to the patient examination table. In some embodiments, as discussed herein, the MTA may be a movable device that can be placed on the patient's chest and used to generate a magnetic field for tracking an object.

[0074] The positional relationship between the image coordinate system and the MPS reference coordinate system (electromagnetic tracking coordinate system) can be calculated based on the system's known optical-magnetic calibration (e.g., established during setup), since in such embodiments, the positioning system and the imaging system can be considered fixed relative to each other. However, for other embodiments using different imaging modes, including embodiments that acquire image data at an earlier time and then import it from an external source (e.g., imaging data stored in a database), it may be necessary to perform a registration step between the MPS coordinate system and the image coordinate system so that the MPS position readings can be properly aligned with any particular image used.

[0075] As previously mentioned, embodiments of this disclosure can be used in conjunction with or for various medical procedures, such as cardiac mapping and / or cardiac ablation procedures. In some embodiments, ablation therapy can be used to treat various conditions that trouble the anatomy of the human body. One such condition for which ablation therapy can be used is the treatment of arrhythmias. Damage is created in tissue when it is ablated or at least subjected to ablation energy generated by an ablation generator and delivered by an ablation catheter. Electrodes mounted on or within the ablation catheter are used to create tissue necrosis in the cardiac tissue to correct conditions such as atrial arrhythmias (including, but not limited to, ectopic atrial tachycardia, atrial fibrillation, and atrial flutter). Arrhythmias can lead to a variety of dangerous conditions, including atrioventricular asynchrony and blood flow stagnation. It is believed that the primary cause of atrial arrhythmias is stray electrical signals within the left or right atrium of the heart. The ablation catheter delivers ablation energy (e.g., radiofrequency energy, cryoablation, laser, chemicals, high-intensity focused ultrasound, etc.) to the cardiac tissue to create damage within it. This damage disrupts unwanted electrical pathways, thereby limiting or preventing stray electrical signals that could lead to arrhythmias.

[0076] In some embodiments, ablation may include electroporation. Electroporation is a non-thermal ablation technique involving the application of a strong electric field that induces pore formation in the cell membrane. The electric field can be induced by applying a pulse of relatively short duration, which can last, for example, from a nanosecond to a few milliseconds. This pulse can be repeated to form a pulse train. When this electric field is applied to tissue in a living environment, cells in the tissue are subjected to a transmembrane potential, thereby opening pores in the cell wall. Electroporation can be reversible (i.e., the temporarily opened pores will reseal) or irreversible (i.e., the pores will remain open), resulting in cell destruction. For example, in the field of gene therapy, reversible electroporation is used to transfect high molecular weight therapeutic vectors into cells. In other therapeutic applications, cell destruction can be induced solely by appropriately configured pulse trains, for example, by inducing irreversible electroporation.

[0077] Figure 1B This is a schematic block diagram of an electroporation treatment system 40 according to an embodiment of the present disclosure. Generally, various embodiments include an electrode assembly 42 disposed at the distal end of a catheter 44. The electrode assembly 42 includes one or more individual electrically insulated electrode elements. Each electrode element (also referred to herein as a catheter electrode) is individually wired such that it can be selectively paired or combined with any other electrode element to act as a bipolar or multipolar electrode.

[0078] System 40 can be used to perform irreversible electroporation to destroy tissue. Specifically, system 40 can be used for electroporation-induced primary necrosis therapy, which refers to the effect of delivering current in a manner that directly causes irreversible loss of the integrity of the plasma membrane (cell wall), leading to its rupture and cell necrosis. This cell death mechanism can be viewed as an "outside-in" process, meaning that the destruction of the cell outer wall has a detrimental effect on the cell interior. Typically, for classic plasma membrane electroporation, current is delivered as a pulsed electric field (i.e., pulsed field ablation (PFA)) in the form of short-duration (e.g., 0.1 to 20 ms) direct current pulses between closely spaced electrodes (capable of delivering an electric field strength of approximately 0.1 to 1.0 kV / cm).

[0079] System 40 includes a catheter electrode assembly 42, which includes at least one catheter electrode configured for use as briefly described above and in more detail below. The electrode assembly 42 is incorporated as part of a medical device (e.g., a catheter 44 for electroporation treatment of tissue 46 in a patient's body 48). In the illustrative embodiment, tissue 46 includes the heart or cardiac tissue. However, it should be understood that the embodiment can be used to perform electroporation treatment of various other body tissues.

[0080] Figure 1AFurther illustration shows a plurality of return electrodes, identified as 50, 52, and 54, which are schematic diagrams of body connectors that can be used by various subsystems included in the overall system 40, such as electroporation generator 56, electrophysiological (EP) monitors (e.g., ECG monitor 60), and localization and navigation system 62 for visualization, mapping, and navigation of internal body structures. In the illustrated embodiment, return electrodes 50, 52, and 54 are patch electrodes. It should be understood that the illustration of a single patch electrode is merely schematic (for clarity), and such subsystems to which these patch electrodes are connected may include, and will typically include, more than one patch (body surface) electrode.

[0081] In some embodiments, return electrodes 50, 52, and 54 can be any other type of electrode suitable for use as a return electrode, including, for example, one or more catheter electrodes. The return electrode of a catheter electrode can be part of electrode assembly 42 or part of a separate catheter (not shown). System 40 may also include a host computer system 64 (including electronic control unit 78 and data storage—memory 80), which in some embodiments may be integrated with system 62. In some embodiments, host computer system 64 may be integrated with... Figure 1A The computer system 20 depicted is integrated. System 64 may also include conventional interface components, such as various user input / output mechanisms 66A and displays 66B, as well as other components. A variable impedance device 58 causes the impedance of the system to vary to limit arcing from the conduit electrodes of conduit 44. In some embodiments, the variable impedance device 58 is variable in response to appropriate control signals from computer system 64.

[0082] In an illustrative embodiment, conduit 44 includes a cable connector or interface 68, a handle 70, and a shaft 72 having a proximal end 74 and a distal end 76. Conduit 44 may also include other conventional components not illustrated herein, such as temperature sensors, additional electrodes, and corresponding conductors or leads. Connector 68 provides mechanical and electrical connections for the cable 82 extending from generator 56. Connector 68 may include conventional components known in the art and is positioned at the proximal end of conduit 44 as shown.

[0083] Figure 2A This is a top view of a high-density electrode conduit 101 according to various embodiments of the present disclosure. Figure 2BThese are isometric side and top views of the high-density electrode conduit 101. In some embodiments, the high-density electrode conduit 101 may include a flexible tip portion 110 forming a flexible array of electrodes 102. This planar array (or "paddle" configuration) of the electrodes 102 includes four longitudinally extending arms 103, 104, 105, and 106 arranged side-by-side, which may form a flexible frame on which the electrodes 102 are disposed. The four electrode-carrying arms may include a first outer arm 103, a second outer arm 106, a first inner arm 104, and a second inner arm 105 that can be engaged at their distal ends via a distal connection portion 109. These arms may be laterally separable from each other.

[0084] Each of the four arms can carry multiple electrodes 102. For example, each of the four arms can carry electrodes 102 spaced along the length of each of the four arms. Although in Figure 2A and Figure 2B Each of the high-density electrode conduits 101 depicted in the diagram is shown with four arms, but the high-density electrode conduits 101 may include more or fewer arms. Additionally, although... Figure 2A and Figure 2B The high-density electrode conduit 101 depicted in the diagram shows 18 electrodes (e.g., 5 electrodes each on the first outer arm 103 and the second outer arm 106, and 4 electrodes each on the first inner arm 104 and the second inner arm 105), but the conduit may include more or fewer than 18 electrodes. Additionally, the first outer arm 103 and the second outer arm 106 may include more or fewer than 5 electrodes, and the first inner arm 104 and the second inner arm 105 may include more or fewer than 4 electrodes.

[0085] In some embodiments, electrode 102 can be used for diagnostic, therapeutic, and / or mapping procedures. For example, but not limited to, electrode 102 can be used for electrophysiological studies, pacing, cardiac mapping, and ablation. In some embodiments, electrode 102 can be used to perform unipolar or bipolar ablation. Such unipolar or bipolar ablation can produce specific lesion lines or patterns. In some embodiments, electrode 102 can receive electrical signals from the heart, which can be used for electrophysiological studies. In some embodiments, electrode 102 can perform location or positioning sensing functions related to cardiac mapping.

[0086] In some embodiments, the high-density electrode catheter 101 may include a catheter shaft 107. The catheter shaft 107 may include a proximal end and a distal end. The distal end may include a connector 108 that couples the distal end of the catheter shaft 107 to the proximal end of the planar array. The catheter shaft 107 may define a longitudinal axis aa, such as... Figure 2AAs depicted, the first lateral arm 103, the first medial arm 104, the second medial arm 105, and the second lateral arm 106 may extend substantially parallel to the longitudinal axis aa of the catheter shaft. The catheter shaft 107 may be made of a flexible material, allowing it to pass through the patient's tortuous vascular system. In some embodiments, the catheter shaft 107 may include one or more annular electrodes 111 disposed along the length of the catheter shaft 107. In examples, the annular electrodes 111 may be used for diagnostic, therapeutic, and / or mapping procedures.

[0087] like Figure 2B As depicted, the flexible tip portion 110 can be adapted to conform to tissue (e.g., cardiac tissue). For example, when the flexible tip portion 110 contacts tissue, the flexible tip portion 110 can deflect, thereby allowing the flexible frame to conform to the tissue. In some embodiments, in Figure 2A and Figure 2B The distal arm (or the lower structure of the arm) of the conduit depicted herein, comprising a blade structure (or multiple arms, bearing electrode, flexible frame), is preferably constructed of a flexible or spring-like material (e.g., nitinol) and / or a flexible substrate, as discussed herein. The construction of the arm (including, for example, the length and / or diameter of the arm) and the material can be adjusted or customized to produce, for example, desired elasticity, flexibility, foldability, compliance, and stiffness characteristics, including one or more characteristics that can vary from the proximal end to the distal end of a single arm or between or among multiple arms comprising a single blade structure.

[0088] For example, the foldability of nitinol materials and / or flexible substrates provides the additional advantage of facilitating the insertion of the paddle structure into the delivery catheter or introductor, both during catheter delivery into the body and during catheter removal from the body at the end of the procedure. In some embodiments, a non-conductive housing may be disposed above the material (e.g., nitinol) of the lower structure forming the arm. In some embodiments, as discussed herein, the non-conductive housing may include a tube defining a longitudinally extending lumen through which the lower structure is disposed. In some embodiments, the tube may be formed of a material comprising a polymer.

[0089] Among other things, the disclosed catheters and their multiple electrodes can be used to: (1) define regional propagation mapping of a specific-sized region (e.g., a one-square-centimeter region) within the atrial wall of the heart; (2) identify complex graded atrial electrograms for ablation; (3) identify local focal potentials between the electrodes to obtain higher electrogram resolution; and / or (4) more precisely target the region for ablation. These mapping and ablation catheters are constructed to conform to and maintain contact with cardiac tissue, despite the potential instability of cardiac motion. This enhanced stability of the catheters on the cardiac wall during cardiac motion, due to continuous tissue electrode contact, provides for more accurate mapping and ablation.

[0090] Additionally, the catheters described herein can be used for epicardial and / or endocardial purposes. For example, the planar array embodiments depicted herein can be used in epicardial procedures, wherein the planar array of electrodes is positioned between the myocardial surface and the pericardium. Alternatively, the planar array embodiments can be used in endocardial procedures to rapidly scan and / or analyze the inner surface of the myocardium and quickly create high-density mappings of the electrical properties of cardiac tissue.

[0091] In some embodiments, the use of the high-density electrode conduit 101 may be susceptible to blood clotting on various portions of the high-density electrode conduit 101. For example, blood clotting may occur on the flexible tip portion 110 and / or the connector 108 of the high-density electrode conduit 101. Although blood clotting is discussed herein, in some instances, other materials, such as tissue cells, may collect on the flexible tip portion 110 and / or on the connector 108. If blood clots on the electrode, the clotting may impair the functionality of the electrode. Additionally, if the clotted blood detaches, the clotting on the flexible tip portion 110 and / or the connector 108 may result in blood clots. Therefore, it is beneficial to prevent blood clotting and / or other material accumulation on the flexible tip portion 110 and / or the connector 108, which can be achieved by using the embodiments discussed in this disclosure.

[0092] International Application No. PCT / US2014 / 011940, entitled "Flexible High-Density Mapping Catheter Tips and Flexible Ablation Catheter Tips with Onboard High-Density Mapping Electrodes"; U.S. Application No. 15 / 331,562, entitled "High Density Electrode Mapping Catheter"; and U.S. Application No. 15 / 331,369, entitled "High Density Electrode Mapping Catheter," are incorporated herein by reference as if fully set forth herein. While some embodiments of this disclosure include flexible tip portions comprising diagnostic and / or therapeutic electrodes, embodiments of this disclosure may include flexible and / or rigid tip portions (e.g., distal assemblies) instead of or in addition to flexible tip portions, which may be electrode assemblies or any number of end-use therapeutic and / or diagnostic devices. For example, the tip portion may include, for instance, an ultrasound sensor and / or transducer associated with an intracardiac echocardiography (ICE) catheter; a laser, a balloon, or any other number of therapeutic and / or diagnostic devices.

[0093] In some embodiments, although not depicted, a magnetic position sensor may be included in the catheter shaft 107 of the high-density electrode catheter 101. In some embodiments, the position of the magnetic position sensor may be determined as discussed herein. Based on the position of the magnetic position sensor, the position of the flexible tip portion 110 may be determined. However, in some embodiments, depending on the size of the flexible tip portion 110, the flexible tip portion 110 may extend beyond the range in which the position of the flexible tip portion 110 can be accurately determined by means of a magnetic position sensor disposed in the catheter shaft 107. For example, the longitudinal length of the flexible tip portion 110 may extend beyond the range in which the position of the flexible tip portion 110 can be accurately determined by means of a magnetic position sensor disposed in the catheter shaft 107. Therefore, as further discussed herein, embodiments of this disclosure may include a magnetic position sensor disposed on the flexible tip portion 110 of the high-density electrode catheter 101. In some embodiments, instead of a magnetic position sensor disposed in the catheter shaft 107, one or more magnetic position sensors may be disposed on the flexible tip portion.

[0094] Figure 3AThese are isometric side and top views of a high-density electrode conduit 120 according to various embodiments of the present disclosure. Figure 3B This is a bottom view of a high-density electrode conduit 120 according to various embodiments of the present disclosure. In some embodiments, the high-density electrode conduit 120 may include a flexible tip portion 122 forming a flexible array of electrodes 124. The flexible tip portion 122 may be positioned adjacent to the distal end of a conduit shaft (not shown). In some embodiments, the flexible tip portion 122 may be connected to the conduit shaft via a proximal coupling 128, which is discussed further herein. This planar array (or “paddle” configuration) of electrodes 124 includes five longitudinally extending arms 126-1, 126-2, 126-3, 126-4, 126-5 arranged side by side, which may form a flexible frame on which the electrodes 124 are disposed. As depicted, seven electrodes 124 may be disposed along each of the longitudinally extending arms 126-1, 126-2, 126-3, 126-4, 126-5, for a total of 35 electrodes. In some embodiments, a greater or lesser number of electrodes 124 may be disposed on the flexible tip portion 122. In some embodiments, as further discussed herein, one or more additional electrodes 130 may be disposed along the central arm 126-5 or along another portion of the flexible tip portion 122.

[0095] Although five arms 126-1, 126-2, 126-3, 126-4, and 126-5 arranged side-by-side are depicted, embodiments of this disclosure may include fewer or more than five arms. In some embodiments, the five electrode-carrying arms may include a first outer arm 126-1, a second outer arm 126-4, a first inner arm 126-2, a second inner arm 126-3, and a central arm 126-5 that can be engaged at their distal ends via a distal coupling member 136. In some embodiments, the distal coupling member 136 may extend longitudinally and define one or more transverse lumens 138-1, 138-2 extending therethrough. In some embodiments, the distal portions of the first outer arm 126-1 and the second outer arm 126-2, as well as the first inner arm 126-2 and the second inner arm 126-3, may extend through the transverse lumens 138-1, 138-2, thereby coupling arms 126-1, 126-2, 126-3, 126-4 together. However, as further discussed herein, in some embodiments, arms 126-1, 126-2, 126-3, 126-4, 126-5 may not be coupled together at their distal ends.

[0096] In some embodiments, the flexible tip portion 122 may include a magnetic position sensor 209, such as Figure 3J As can be further seen in the images. In some embodiments, the magnetic position sensor 209 may be disposed along the distal portion of the flexible frame forming the flexible tip portion 122. Although in Figure 3A The magnetic position sensor 209 is hidden and not visible, but it can be located within the center electrode 130. For example, as... Figure 3J As further described, the central electrode 130 can define a cavity in which the magnetic position sensor 209 is disposed.

[0097] In some embodiments, the magnetic position sensor 209 may be disposed on and / or within a portion of the flexible tip portion 122. In some embodiments, the distal portion of the flexible tip portion 122 may define a mounting feature for the magnetic position sensor 209. In some embodiments, the mounting feature may include a cutout in the portion of the flexible tip portion 122, a groove in the portion of the flexible tip portion, a lumen in the portion of the flexible tip portion, etc. In some embodiments, the cutout may be defined in one of the arms 126-1, 126-2, ..., 126-5, in the distal coupling member 136, in the frame forming one of the arms 126-1, 126-2, ..., 126-5, or at other locations in the flexible tip portion 122.

[0098] In some embodiments, a recess may be defined in one of the arms 126-1, 126-2, ..., 126-5, in the distal coupling 136, in the frame forming one of the arms 126-1, 126-2, ..., 126-5, or at another location in the flexible tip portion 122. In some embodiments, as discussed herein, the central electrode 130 may define a lumen therein in which the magnetic position sensor 209 is disposed. In some embodiments, the lumen may be formed in other structures included in the flexible tip portion 122. For example, the lumen may be defined in one of the arms 126-1, 126-2, ..., 126-5, in the distal coupling 136, in the frame forming one of the arms 126-1, 126-2, ..., 126-5, or at another location in the flexible tip portion 122. Although some examples of mounting features are provided, the examples are not limited thereto, and other types of mounting features may be included.

[0099] In some embodiments, the magnetic position sensor 209 may be disposed at the distal end of the central arm 126-5. In some embodiments, the magnetic position sensor 209 may sense position and / or orientation having five degrees of freedom (5 DOF) or six degrees of freedom (6 DOF). As further discussed herein, one or more magnetic position sensors 134-1, 134-2 ( Figure 3BThe magnetic position sensors 209, 134-1, 134-2 can be disposed within the proximal coupling member 128 and / or along the conduit axis (not depicted) connected thereto, and can be electrically coupled to the computer system 20 via wires 154-1, 154-2 (e.g., twisted pair). The magnetic position sensors 209, 134-1, 134-2 can be disposed in a magnetic field and can generate one or more signals that indicate the position and / or orientation of the magnetic position sensors 209, 134-1, 134-2.

[0100] In some embodiments, the longitudinal length of the flexible tip portion 122 may allow the position of the distal end of the flexible tip portion 122 to be determined without being determined by a magnetic position sensor located at the distal end of the conduit shaft. For example, the distal portion of the flexible tip portion 122 may extend beyond the area of ​​the magnetically accurate position information and software used in determining the position of the flexible tip portion. Therefore, the position and / or orientation of the flexible tip portion 122 may not be accurately determined. Therefore, the position and / or orientation of a magnetic position sensor 209 disposed at the distal end of the flexible tip portion 122 can be determined, and the position of the magnetic position sensor 209 can be used to determine the position and / or orientation of the distal end of the flexible tip portion 122 that may extend beyond the area of ​​the magnetically accurate position information.

[0101] In some embodiments, the magnetic position sensor 209 may be disposed on a portion of the flexible tip portion 122 that extends beyond the area from which magnetically correct position information is provided by one or more magnetic position sensors 134-1, 134-2 disposed on the proximal coupling member 128 and / or on the distal end of the conduit shaft, from which the flexible tip portion 122 extends. Although the magnetic position sensor 209 is generally discussed as being disposed on the central arm 126-5, the magnetic position sensor 209 may be located at other locations along the flexible tip portion 122 to enable determination of the position of the flexible tip portion 122.

[0102] In some embodiments, the center electrode 130 may be cylindrical and may extend distally from the center arm 126-5. The center electrode 130 may accommodate a magnetic position sensor 209. Figure 3J This also provides the functionality of electrodes that can be used for diagnostic and / or therapeutic purposes, as discussed herein. The distal end of the central electrode 130 can be connected to a distal coupling 136. The distal coupling 136 can couple the distal ends of the central arm 126-5, the distal ends of the first lateral arm 126-1 and the second lateral arm 126-4, and the distal ends of the first medial arm 126-2 and the second medial arm 126-3. As previously mentioned, although regarding... Figure 3AThe distal coupling 136 is depicted, but it is not mandatory. For example, the frame forming the flexible tip portion 122 of the high-density electrode catheter 120 may not be coupled together at a location remote from the proximal coupling 128 and / or the distal end of the catheter shaft, from which the flexible tip portion 122 extends. In some embodiments, although not depicted, a magnetic position sensor may be disposed on one or more portions of the uncoupled frame to enable determination of the position of the uncoupled frame and / or one or more portions thereof.

[0103] In some embodiments, although not depicted, the central electrode 130 may include one or more electrodes disposed on the exterior of the magnetic position sensor 209. For example, in some embodiments, the central electrode 130 may be divided into multiple portions (e.g., a top half, a bottom half) disposed around the central electrode 130. In some embodiments, one or more point electrodes may be disposed on the magnetic position sensor 209. In some embodiments, the central electrode 130 may be formed of a flexible circuit including one or more electrodes formed thereon, which may be disposed on the magnetic position sensor 209.

[0104] In some embodiments, the central arm 126-5 may include an extension feature 140. For example... Figure 3A As depicted, the extension feature 140 may include a non-linear extension feature 140. The non-linear extension feature 140 may include a bend in a portion of the central arm 126-5 that can be straightened, thereby allowing an increase in the longitudinal length of the central arm 126-5 when the bend is in a straightened configuration. For example, in some embodiments, the high-density electrode conduit 120 may be introduced into the body via a sheath. When the high-density electrode conduit 120 is disposed in the sheath, it can be in a stored state, wherein the distance between each of the longitudinally extending arms is reduced. This allows the stored longitudinal length of the flexible tip portion 122 to increase relative to the unfolded length of the device, such as... Figure 3A As depicted in the text.

[0105] As depicted, the first outer arm 126-1 and the second outer arm 126-4, as well as the first inner arm 126-2 and the second inner arm 126-3, have bends (e.g., elbows) along their longitudinal length, causing them to open laterally. For example, with regard to the second outer arm 126-4, the arm includes a proximal bend 142-1 and a distal bend 142-2. When these bends 142-1, 142-2 straighten, the longitudinal length of the second outer arm 126-4 can increase as the flexible tip portion 122 retracts into a stored state. By including an extension feature 140 in the central arm 125-5 (in this embodiment, the central arm 125-5 includes a non-linear extension feature 140), the central arm 125-5 can be extended together with the first outer arm 126-1 and the second outer arm 126-4, as well as the first inner arm 126-2 and the second inner arm 126-3, thereby preventing the central arm 126-5 from pulling the flexible tip portion 122 away from alignment when in the storage state. Without the extension feature 140, in the storage state, the lengths of the first outer arm 126-1 and the second outer arm 126-4, as well as the first inner arm 126-2 and the second inner arm 126-3, would be extended, while the length of the central arm 126-5 would remain unchanged, resulting in a portion of the flexible tip portion 122 folding onto itself.

[0106] As depicted, the proximal coupling member 128 may include a distal coupling member head 144. In some embodiments, the distal coupling member head 144 may be a flushing distal coupling member head 144. In some embodiments, the distal coupling member head 144 may include one or more flushing ports 146-1, 146-2 configured to discharge fluid (e.g., flushing fluid). For example, in some embodiments, the flushing ports 146-1, 146-2 may be configured to dispense fluid in such a way that the fluid substantially covers the flexible tip portion 122. In some embodiments, the flushing ports 146-1, 146-2 may be configured to dispense fluid onto the flexible tip portion 122 to help prevent blood clotting or other material buildup on the flexible tip portion 122. In some embodiments, one or more portions of the flexible tip portion 122 may be prone to blood clotting. Therefore, embodiments of this disclosure may be configured to dispense fluid to one or more of these portions of the flexible tip portion 122 to prevent blood clotting. In some embodiments, the flushing features associated with the proximal coupling member 128 and its distal coupling member head 144 may include one or more features discussed with respect to U.S. Patent Application No. 15 / 585,859, which is incorporated herein by reference as if fully set forth herein.

[0107] Such as about Figure 3AAs depicted, the proximal coupling 128 may include a connecting rod portion 150 that can be inserted into a lumen defined by a conduit shaft. In some embodiments, the connecting rod portion 150 may define a first sensor recess 148-1 and a second sensor recess 148-2 on its outer surface 152. Figure 3B In some embodiments, the first sensor recess 148-1 and the second sensor recess 148-2 may be angled relative to each other and / or relative to the longitudinal axis of the high-density electrode conduit 120. In some embodiments, the first sensor recess 148-1 and the second sensor recess 148-2, as well as the magnetic position sensors 134-1, 134-2, may include those features discussed with respect to U.S. Patent Application No. 15 / 585,859, which is incorporated herein by reference as if fully set forth herein. The configuration of the magnetic position sensors 134-1, 134-2 may allow the position and / or orientation of the proximal coupling member 128 to be determined in six degrees of freedom, and thereby determine the position and / or orientation of the high-density electrode conduit 120.

[0108] In some embodiments, although not depicted, additional electrodes may be provided along the distal portions of arms 126-1, 126-2, 126-3, 126-4, as indicated by arrows 156-1, 156-2. For example, although Figure 3A Electrodes 124 are depicted that are linearly aligned with each other along the linear portions of arms 126-1, 126-2, 126-3, 126-4, but embodiments of the present disclosure may benefit from additional electrodes disposed along the areas indicated by arrows 156-1, 156-2 along arms 126-1, 126-2, 126-3, 126-4.

[0109] In some embodiments, electrodes disposed on the high-density electrode catheter 120 (e.g., one or more of electrodes 124, 130) can be used for various diagnostic and / or therapeutic purposes, including, but not limited to, cardiac mapping and / or ablation. In some embodiments, ablation performed by the electrodes can include a variety of different types of ablation. For example, ablation performed by the electrodes can include monopolar and / or bipolar radiofrequency ablation and / or electroporation, as previously discussed herein.

[0110] In some embodiments, the flexible tip portion 122 may be an electrode assembly configured for use in a bipolar electrode assembly in bipolar-based electroporation therapy. Specifically, as described above, one or more of the electrodes 124 disposed on the flexible frame working member and / or the central electrode 130 may be individually electrically coupled to... Figure 1BThe generator 56 depicted herein (e.g., via a suitable wire or other suitable electrical conductor extending through the conduit shaft 44) is configured to selectively energize with opposite polarities (e.g., via the electroporation generator 56 and / or the computer system 64) to generate a potential and a corresponding electric field therebetween for IRE treatment. That is, one or more of electrodes 124, 130 are configured to serve as a negative electrode, while the other is configured to serve as a positive electrode. One or more of electrodes 124, 130 can be any suitable electroporation electrode. In an exemplary embodiment, one or more of electrodes 124, 130 can be a ring electrode. One or more of electrodes 124, 130 can have any other shape or configuration.

[0111] It should be recognized that the shape, size, and / or configuration of one or more of electrodes 124, 130 can affect various parameters of the applied electroporation treatment. For example, increasing the surface area of ​​one or more of electrodes 124, 130 can reduce the applied voltage required to induce the same level of tissue damage. Although only electrode 124 is referred to in this discussion, the discussion herein can be applied to any of the electrodes depicted on the flexible tip portion 122 of the high-density electrode catheter 120. While electrodes 124, 130 disposed on the flexible tip portion 122 are described as bipolar electrode assemblies, it should be understood that in some embodiments, electrodes 124, 130 disposed on the flexible tip portion 122 may be configured as unipolar electrode assemblies, and patch electrodes (e.g., return electrode 50) may be used as return or neutral electrodes.

[0112] Figure 3C According to embodiments of this disclosure Figure 3A and Figure 3B The high-density electrode conduit 120 is depicted in the figure. As depicted, a flexible tip portion 122 extends distally from the proximal coupling member 128. In some embodiments, the distal end of the distal coupling member head 144 may include a longitudinal and transverse groove 157, through which a first outer arm 126-1 and a second outer arm 126-4, as well as a first inner arm 126-2 and a second inner arm 126-3, may extend distally from the distal coupling member head 144 from a plane bisecting the longitudinal axis aa of the distal coupling member head 144 and the connecting rod portion 150.

[0113] In some embodiments, the central arm 126-5 may extend below the longitudinal axis aa and below the positions where the first outer arms 126-1 and the second outer arms 126-4, and the first inner arms 126-2 and the second inner arms 126-3 extend from the distal coupling head 144. In some embodiments, the central arm 126-5 may include an extension feature 140. For example, the central arm 126-5 may be located away from the distal end of the distal coupling head 144 and may extend distally and upward, thereby rising through the plane defined by the first outer arms 126-1 and the second outer arms 126-4, and the first inner arms 126-2 and the second inner arms 126-3. Reference Figure 3C The longitudinal axis aa can extend through the plane defined by the first outer arm 126-1 and the second outer arm 126-4, and the first inner arm 126-2 and the second inner arm 126-3. Then, after reaching the peak 158, the central arm 126-5 can extend downward toward the plane defined by the arms 126-1, 126-2, 126-3, and 126-4. As previously discussed, when the flexible frame is in the storage configuration, the longitudinal lengths of the arms 126-1, 126-2, ..., 126-5 can be extended, and the bend in the extension feature 140 can be flattened, thereby allowing the central arm 126-5 to extend.

[0114] Figure 3D According to embodiments of this disclosure Figures 3A to 3C Isometric side and bottom views of the high-density electrode conduit 120 depicted in the figure. Figure 3D A third flushing port 146-3 and a fourth flushing port 146-4 are depicted defined in the distal face of the distal coupler head 144. In some embodiments, the distal coupler head 144 may define a lumen 160 into which adhesive may be injected to fill the interior of the proximal connection portion of the lower structure receiving arms 126-1, 126-2, ..., 126-5, as further depicted herein. In some embodiments where the flexible tip portion includes six arms, the lumen 160 may allow insertion of a sixth arm, as described regarding... Figure 5A The descriptions and discussions.

[0115] Figure 3E According to embodiments of this disclosure Figures 3A to 3D The isometric top and side views of the high-density electrode conduit 120ʹ depicted in the figure further depict the manifold portion 162. Figure 3F According to embodiments of this disclosure Figures 3A to 3EThe isometric bottom and side views of the high-density electrode conduit 120ʹ depicted further depict the manifold portion 162. In some embodiments, the manifold portion 162 can direct fluid to each flushing port defined in the distal face of the distal coupling head 144. In some embodiments, the manifold portion 162 may be in the connecting rod portion 150 and / or mounting portion 176 ( Figure 3G A hollow cylindrical tube extending above the distal end of the tube.

[0116] Manifold portion 162 may define a circumferential manifold 164, which is defined in the outer surface of manifold portion 162. As depicted, the circumferential manifold 164 may extend circumferentially around manifold portion 162 and may be defined by recessed manifold portion 170, the inner surface of distal coupling head 144, and manifold walls 166-1, 166-2. Figure 3F As depicted, manifold walls 166-1, 166-2 can define the proximal and distal ends of the circumferential manifold 164 and can be fluidly sealed by means of the inner surface of the distal coupling head 144.

[0117] In some embodiments, a fluid lumen may be defined in the connecting rod portion 150, as further described and discussed herein. The fluid lumen may be in fluid communication with a fluid inlet 168, which may be defined in a recessed manifold portion 170 and may extend between the inner surface of the manifold portion 162 and the outer surface of the recessed manifold portion 170. In the example, fluid may be introduced through the fluid inlet 168 into a circumferential manifold 164, thereby filling the circumferential manifold 170 with fluid. The recessed manifold portion 170 may further define fluid outlets 172-1, 172-2, 172-3, and 172-4 (fluid outlet 172-4 is hidden and not visible). Each of the fluid outlets 172-1, 172-2, 172-3, and 172-4 may be fluidly coupled to fluid delivery lines 174-1, 174-2, 174-3, and 174-4, respectively.

[0118] Fluid delivery pipes 174-1, 174-2, 174-3, and 174-4 can be confined within the mounting portion 176. Regarding... Figure 3G This was discussed further. For example... Figure 3F As depicted, each of the delivery pipes 174-1, 174-2, 174-3, and 174-4 can be confined in the distal face of the mounting portion 176. Figure 3G According to embodiments of this disclosure Figures 3A to 3F The high-density electrode conduit 120ʹʹ is depicted in isometric top and side views, with the mounting portion 176 further depicted. Figure 3H According to embodiments of this disclosure Figures 3A to 3GIsometric bottom and side views of the high-density electrode conduit 120ʹʹ depicted, further illustrating the mounting portion 176. In some embodiments, the mounting portion 176 may be disposed at the distal end of the connecting rod portion 150. As depicted, the mounting portion 176 may be cylindrical and may define delivery tubes 174-1, 174-2, 174-3, 174-4 through which flushing fluid may flow and may be guided out of flushing ports 146-1, 146-2, 146-3, 146-4. Figure 3A and Figure 3D ).

[0119] In some embodiments, the mounting portion 176 may define a receiving cavity in which the connecting rod portion 150 may be received. In some embodiments, a plurality of adhesive holes 180-1, 180-2, 180-3, 180-4 (180-4 is hidden and not visible) may be defined on the outer surface of the mounting portion 176. Adhesive may be injected into the adhesive cavity 178, and the adhesive may flow through the internal portion of the mounting portion 176 and into the adhesive holes 180-1, 180-2, 180-3, 180-4, thereby securing the mounting portion 176 to the connecting rod portion 150 and the manifold portion 162. Figure 3F As further described, the proximal ends of arms 126-1, 126-2, ..., 126-5 can be disposed within the distal end of mounting portion 176, such that they are fixedly positioned relative to mounting portion 176.

[0120] In some embodiments, the installation portion 176 may be included in Figure 3M The flushing through-hole 182 is further depicted in the image. The flushing through-hole 182 can be connected to the flushing cavity 280 defined in the connecting rod portion 150. Figure 3Q Fluid coupling. For example, flushing lumen 280 may be defined in connecting rod portion 150 and may extend longitudinally through connecting rod portion 150. Flushing lumen 280 may supply flushing fluid to through hole 182 and thus to fluid inlet 168.

[0121] Figure 3I These are isometric top and side views of a flexible underlayer structure 190 of a high-density electrode conduit 120 depicted herein according to embodiments of the present disclosure. Figure 3J According to embodiments of this disclosure Figures 3A to 3IThe image shows isometric bottom and side views of the flexible substructure 190 of the high-density electrode conduit depicted. The flexible substructure 190 may include a first outer frame 192-1, a first inner frame 192-2, a central frame 192-5, a second inner frame 192-3, and a second outer frame 192-4. The first outer frame 192-1 and the first inner frame 192-2 are shown covered by corresponding tubes 194-1 and 194-2, which pass through the corresponding tubes 194-1 and 194-2. In some embodiments, the tubes 194-1 and 194-2 may be double-lumen tubes, as in... Figure 3K As further described, this allows the frame 192-1 to pass through the first lumen 198 of the double-lumen tube, and allows multiple wires 196 to pass through the second lumen 200 of the double-lumen tube, which is separated from the first lumen 198 via a planar transverse member 202.

[0122] Further reference Figure 3I The central frame 192-5 may include a non-linear extension feature 204, as previously discussed herein, which allows the central frame 192-5 to extend as the outer frames 192-1, 192-4 and the inner frames 192-2, 192-3 in the storage configuration extend. As depicted, one non-linear extension feature 204 is shown; however, more than one non-linear extension feature may be included along the central arm 192-5. For example, in some embodiments, a series of undulations may be included along the central arm 192-5, each of which flattens as the central arm 192-5 extends together with the outer frames 192-1, 192-4 and the inner frames 192-2, 192-3.

[0123] In some embodiments, the proximal end of each of frames 192-1, 192-2, ..., 192-5 includes frame mounting portions 206-1, 206-2, ..., 206-5 that can engage mounting portion 176, as discussed herein. Frames 192-1, 192-2, ..., 192-5 may be formed of a flexible material, which in some embodiments may include a metal (e.g., nitinol). As further depicted, frames 192-1, 192-2, ..., 192-5 may include a planar cross-section, as further discussed in relation to U.S. Application No. 15 / 331,369 entitled “High Density Electrode Mapping Catheter,” which is incorporated herein by reference as if fully set forth herein. In some embodiments, frame mounting portions 206-1, 206-2, ..., 206-5 may be disposed in corresponding openings and / or lumens defined in mounting portion 176, as discussed herein. Figure 3M Further discussion is needed.

[0124] Figure 3L According to embodiments of this disclosure Figure 3H Isometric bottom and side views of the high-density electrode conduit 120ʹʹʹ depicted, wherein tube 194 does not cover the flexible underlying structure 190. As can be seen, the proximal end of each of frames 192-1, 192-2, ..., 192-5 may be disposed within the mounting portion 176. For example, as depicted, one side of frame mounting portion 206-1 protrudes visibly within a mounting cutout 210 defined in the proximal end of mounting portion 176. As depicted, mounting cutout 210 may be an opening (e.g., a slot) extending distally from the proximal end of mounting portion 176, having a circumferential width at least as large as the thickness of frame mounting portion 206-1. Figure 3M As depicted, the opposite side of the mounting portion 176 may include a mounting cutout 225.

[0125] Figure 3M This is an isometric proximal view of the mounting portion 176 according to an embodiment of the present disclosure. As depicted, the mounting portion 176 defines adhesive holes 180-1, 180-2, 180-3, 180-4 through which adhesive can be disposed to secure the mounting portion 176, as discussed herein. As further depicted, the mounting portion 176 may include a flushing through-hole 182 through which flushing fluid can flow and be supplied by a manifold portion 162 ( Figure 3F Allocation. Regarding Figure 3P Other aspects of the installation process were discussed.

[0126] Figure 3N These are isometric bottom and side views of the near end of a flexible substructure 190 according to an embodiment of the present disclosure. Figure 3MThis is a bottom view of the proximal end of a flexible substructure 190 according to an embodiment of the present disclosure. As depicted, the proximal end of each of the frames 192-1, 192-2, ..., 192-5 may include frame mounting portions 206-1, 206-2, ..., 206-5. Frame mounting portions 206-1, 206-2, ..., 206-5 may be configured to engage with mounting portion 176 to lock the frame mounting portions 206-1, 206-2, ..., 206-5, and thus the frames 192-1, 192-2, ..., 192-5, in place relative to mounting portion 176. In some embodiments, frame mounting portions 206-1, 206-2, ..., 206-5 may include clamping portions that utilize spring tension provided by the frames 192-1, 192-2, ..., 192-5 to engage corresponding clamping portions defined in mounting portion 176. In some embodiments, the flexibility associated with frames 192-1, 192-2, ..., 192-5 can provide spring tension.

[0127] In some embodiments, the center frame mounting portion 206-5 may include a spring clamp 228 relative to the center frame 192-5. As depicted, a spring post 230 may extend proximally relative to the center frame 192-5 and may be connected to the spring clamp 228 via a spring connector at its proximal end. In some embodiments, a spring gap 234 may be defined between the spring post 230 and the spring clamp 228. In operation, when the center frame mounting portion 206-5 is pushed through the mounting cavity 269 ( Figure 3M When the spring gap 234 is in use, it can provide space for the spring clamp 228 to compress toward the spring post 230, as discussed further herein. As discussed further, the mounting cavity 269 can have a shape complementary to the cross-section of the central frame 192-5, thereby allowing the central frame mounting portion 206-5 to be pushed through the mounting cavity 269.

[0128] Further reference Figure 3O When the spring clamp 228 is in the engaged configuration, the distal end 232 of the spring clamp 228 can protrude beyond the corresponding frame edge 238. When the spring clamp 228 is pushed through the corresponding mounting cavity 269 ( Figure 3M When the spring clamp 228 is pushed toward the spring post 230, the distal end 232 of the spring clamp becomes more flush with the corresponding frame edge 238, thereby allowing the central frame mounting portion 206-5 to be pushed through the mounting cavity 269.

[0129] Regarding the first inner frame 192-2 and the second inner frame 192-3, their respective frame mounting portions 206-2, 206-3 may include frame clamps, as depicted. For simplicity, the discussion of the frame clamps associated with the frame mounting portions will be limited to the second inner mounting portion 206-3. The first inner mounting portion 206-2 may include the same or similar features as the second inner mounting portion 206-3. As depicted, the second inner mounting portion 206-3 may include a clamp cutout 240 defined in the inner edge 242 of the second inner frame 192-3. In some embodiments, the clamp cutout 240 may be complementary to an inner locking post 260 defined in the mounting portion 176, as referenced herein. Figure 3P Further description and discussion. For example, an inner locking post 260 defined in the mounting portion 176 may be provided in the clamp cutout 240, thereby locking the second inner mounting portion 206-3 into place.

[0130] As further depicted, the second inner mounting portion 206-3 may include a ramp portion 244 that allows the second inner frame 192-3 to deflect above the inner locking post 260 when the second inner frame 192-3 is pushed into the mounting portion 176. In some embodiments, the second inner frame 192-3 and the first inner frame 192-2 may be connected and thus can be pushed into the mounting portion 176 simultaneously. As depicted, the first inner mounting portion 206-2 and the second inner mounting portion 206-3 may deflect away from each other when their respective ramps contact the inner locking post 260.

[0131] As depicted, the second inner mounting portion 206-3 may further include a retaining shelf 246, which may be contacted by an engaging protrusion 250 disposed on the opposing proximal inner edges of the second outer mounting portion 206-4, as discussed herein. With regard to the second outer mounting portion 206-4, the second outer mounting portion 206-4 may include features similar to those of the second inner mounting portion 206-3. For example, the second outer mounting portion 206-4 may include a clamping notch 248 and a ramp portion 252 for engaging with an outer locking post 262 disposed in the mounting portion 176.

[0132] As further discussed herein, in some embodiments, the first inner mounting portion 206-2 and the second inner mounting portion 206-3 may be inserted into the mounting portion 176 first, and then the first outer mounting portion 206-1 and the second outer mounting portion 206-4 may be inserted. With respect to the second outer mounting portion 206-4 and the second inner mounting portion 206-3, the engaging protrusion 250 may press against the retaining shelf 246, thereby applying a retaining force between the engaging protrusion 250 and the retaining shelf 246, ensuring that the clamp cutouts 240, 248 remain engaged with their respective locking posts 260, 262.

[0133] Figure 3P This is a bottom view, depicted in cross-sectional view, of the proximal end of a flexible lower structure 190 disposed in a mounting portion 176 according to an embodiment of the present disclosure. As depicted and as previously mentioned, the mounting portion may include an inner locking post 260 and an outer locking post 262. As discussed, in some embodiments, a first inner frame 192-2 and a second inner frame 192-3 may be inserted into the mounting portion 176. In some embodiments, an extension (e.g., an electrical wire) may be attached to the proximal end of each inner and / or outer mounting portion 206-1, 206-2, ..., 206-4 and may pass through openings 264, 268 defined between the inner locking post 260 and the outer locking posts 262, 266 (also in... Figure 3M (as depicted in the figure). In some embodiments, the extension can be pulled proximally to help push the inner / outer mounting portions 206-1, 206-2, ..., 206-4 proximally to engage with each corresponding inner / outer locking post 260, 262.

[0134] As discussed, in some embodiments, when the inner mounting portions 206-2, 206-3 are pushed into place to engage the clamp cutout 240 with the inner locking post 260, the ramp portion 244 may begin to contact the outer distal edge of the locking post 260. The contact between the ramp portion 244 and the distal edge of the locking post 260 may separate the second inner mounting portion 206-3 from the first inner mounting portion 206-2. Although not labeled, the ramp portion associated with the first inner mounting portion 206-2 may contact the corresponding proximal edge of the locking post 260, thereby also separating the first inner mounting portion 206-2 from the second inner mounting portion 206-3. For example, in some embodiments, in Figure 3P Under the configuration described herein, the first inner frame 192-2 and the second inner frame 192-3 can be naturally offset.

[0135] When the inner mounting portions 206-2 and 206-3 are inserted into the mounting portion 176, the first inner frame 192-2 and the second inner frame 192-3 can be deflected from their natural biased state. When the first inner frame 192-2 and the second inner frame 192-3 are inserted into the mounting portion 176 to the point where their respective clamping notches (e.g., clamping notches 240) are aligned with the inner locking post 260, the first inner frame 192-2 and the second inner frame 192-3 can return to their natural biased state, thereby locking them in place relative to the inner locking post 260.

[0136] In some embodiments, the first outer frame 192-1 and the second outer frame 192-4 can be inserted into corresponding openings 264 and 268 defined between the inner locking post 260 and the outer locking posts 262 and 266. In some embodiments, after the first inner mounting portion 206-2 and the second inner mounting portion 206-3 have been inserted into the openings 264 and 268 and locked in place with the inner locking post 260, the first outer mounting portion 206-1 and the second outer mounting portion 206-4 can be inserted into the openings 264 and 268. When the first outer mounting portion 206-1 and the second outer mounting portion 206-4 are inserted into their respective openings 264, 268, the ramp portions 252, 253 of each of the first outer mounting portion 206-1 and the second outer mounting portion 206-4 can contact the inner distal edge of each of the respective outer locking posts 262, 266, thereby causing the first outer mounting portion 206-1 and the second outer mounting portion 206-4 to deflect inward toward each other.

[0137] Each of the first outer mounting portion 206-1 and the second outer mounting portion 206-4 can be inserted proximally through corresponding openings 264, 268 until the respective clamping notches 248, 270 of the first outer mounting portion 206-1 and the second outer mounting portion 206-4 are aligned with each outer locking post 262, 266. When the outer locking posts 262, 266 are aligned with each of the first clamping notches 248 and the second clamping notches 270, the first outer mounting portion 206-1 and the second outer mounting portion 206-4 can expand laterally, thereby allowing the first outer locking post 262 and the second outer locking post 266 to be in place in each clamping notch 248, 270.

[0138] As previously discussed, each of the first outer mounting portion 206-1 and the second outer mounting portion 206-4 may include an engaging protrusion 250. For simplicity, the discussion of the engaging protrusion will be limited to the second outer mounting portion 206-4, but the first outer mounting portion 206-1 includes the same or similar features. As depicted, when the second outer mounting portion 206-4 is inserted and the clamping notch 248 engages with the outer locking post 262, the engaging protrusion 250 may engage with the retaining shelf 246. In some embodiments, the engaging protrusion 250 may abut against the retaining shelf 246 to prevent both clamping notches 240, 248 from disengaging from their respective locking posts 260, 262.

[0139] As shown in the figure, the central frame 192-5 may include a central mounting portion 206-5. In some embodiments, the mounting portion 176 may define a mounting cavity 269. Figure 3M The mounting lumen 269 extends longitudinally through the mounting portion 176 and has a similar cross-sectional dimension to the center arm 192-5. In some embodiments, the center mounting portion 206-5 may advance through the longitudinally extending mounting lumen 269 in the mounting portion 176 in a proximal direction. As the center mounting portion 206-5 advances through the mounting lumen 269 in the mounting portion 176, the spring clamp 236 may be compressed toward the spring post 230 until the spring clamp passes through the mounting lumen 269, thereby allowing the spring clamp 236 to extend and thus lock the center mounting portion 206-5 in place, preventing the center mounting portion 206-5 from being pulled distally from the mounting lumen 269.

[0140] Such as about Figure 3M Further depiction shows that, in some embodiments, a wire conduit 271, 273 may be defined in the distal face of the mounting portion 176. In some embodiments, the wire conduit 271 may provide for wiring wires to the flexible tip portion 122 ( Figure 3A The space, as discussed in this article.

[0141] Figure 3Q This is an isometric far-end view of the connecting rod portion 150 according to an embodiment of the present disclosure. Figure 3R According to embodiments of this disclosure Figure 3G The image shows an isometric proximal view of the connecting rod portion 150. As depicted, the connecting rod portion 150 may include a flushing lumen 280 extending therethrough. As previously discussed, the flushing lumen 280 may supply flushing fluid from the proximal end of the connecting rod portion 150 to a fluid inlet 168, as per [reference to...]. Figure 3FAs discussed herein, the connecting rod portion 150 may define a first sensor recess 148-1 and a second sensor recess 148-2. The distal end of the connecting rod portion 150 may include a tapered portion 284, through which longitudinal and transverse slots for insertion into a flexible frame may be defined. In some embodiments, the tapered portion may engage with the inner surface of the manifold portion 162.

[0142] like Figure 3Q As depicted, the flushing lumen 280 may be defined together with the first sensor recess 148-1 and the second sensor recess 148-2 in the proximal end of the connecting rod portion 150. In some embodiments, the connecting rod portion 150 may include a central lumen 286 extending therethrough. As depicted, the cross-section of the central lumen 286 may be elliptical in shape, but may be other shapes (e.g., circular, square, rectangular, etc.). In some embodiments, one or more wires may pass through the central lumen 286, the one or more wires being connected to electrodes 124 disposed on the flexible tip portion 122. Figure 3A ), and a magnetic position sensor 209 disposed on the flexible tip portion 122. Figure 3J It may be associated with other devices and / or sensors disposed on the flexible tip portion 122.

[0143] Further reference Figure 3J In some embodiments, the high-density electrode conduit, as discussed herein, may include a magnetic position sensor disposed on a flexible tip portion of the conduit. Figure 3J As depicted herein, in some embodiments, the magnetic position sensor 209 may be disposed along the distal portion of the flexible tip portion of the high-density electrode conduit. In some embodiments, the position of the magnetic position sensor 209 may be determined and used to locate one or more portions of the flexible tip portion, as discussed herein. In some embodiments, the flexible understructure 190 may include a magnetic position sensor mount 211 disposed on the distal portion 208 of the flexible understructure 190. In some embodiments, the magnetic position sensor mount 211 may accommodate the magnetic position sensor 209. For example, the magnetic position sensor mount 211 may define a longitudinally extending groove 213 in which the magnetic position sensor 209 may be disposed, as will be described below. Figure 3S and Figure 3T To be further described.

[0144] In some embodiments, the magnetic position sensor mount 211 can be used as Figure 3AThe electrode underlayer structure of the central electrode 130 depicted. In some embodiments, the magnetic position sensor 209 may be disposed within the slot 213, and a tubular conductive layer (e.g., the central electrode 130) may be disposed above the outer surface of the magnetic position sensor mount 211. Figure 3J As depicted, a channel 215 may be defined in the proximal outer surface of the magnetic position sensor mount 211. In some embodiments, wires may be disposed within the channel 215 and coupled to the magnetic position sensor mount 211 (e.g., via soldering). Although not depicted, the wires may electrically couple the magnetic position sensor mount 211, and thus the central electrode 130, to the computer system 20. This allows for a dual-purpose magnetic position sensing and electrode assembly.

[0145] In some embodiments, the magnetic position sensor mount 211 may be coupled to the distal coupling 136. In some embodiments, the distal coupling 136 and the magnetic position sensor mount 211 may be formed from a single piece of material. The magnetic position sensor mount 211 may be connected to the distal end of the central frame 192-5, and thus the central frame 192-5 may be connected to the distal coupling 136. In some embodiments, the magnetic position sensor mount 211 may include a keyway 217, which may be configured to receive the distal end of the central frame 192-5, such as... Figure 3S To better depict it.

[0146] Figure 3S According to embodiments of this disclosure Figure 3J The image shows a bottom view of the distal portion 208' of the flexible substructure 190' depicted, with added electrodes 124, a distal lateral substructure tube 290, and a non-invasive tip 292. As depicted, the first lateral arm 126-1 and the second lateral arm 126-4 may include a plurality of electrodes 124 disposed thereon. In some embodiments, the substructure forming the first lateral arm 126-1 and the second lateral arm 126-4 may be covered by a tube, which may be a dual-lumen tube, as described above. Figure 3J As depicted and discussed herein. In some embodiments, as mentioned herein, the tube may be formed of a non-conductive material (e.g., a polymer). As depicted, the first inner frame 192-2 is shown covered by the tube at a location positioned distal to the electrode 124.

[0147] In some embodiments, a dual-lumen tube may be used to cover the portion of the flexible underlayer along which electrodes are disposed. For example, in some embodiments, at least one wire may be associated with each electrode, and the at least one wire may be routed proximally along the flexible tip portion. Using a dual-lumen tube for the portion of the flexible underlayer along which electrodes are disposed allows the wire to be disposed in a first lumen of the dual-lumen tube, with a frame (e.g., a first inner frame 192-2) routed in a second lumen of the dual-lumen tube. For the portion of the flexible underlayer that does not include electrodes, in some embodiments, a single-lumen tube 290 may be used to cover the flexible underlayer, as depicted for the first outer arm 126-1 and the second outer arm 126-4.

[0148] In some embodiments, as discussed herein, the flexible substructure 190ʹ may include a magnetic position sensor mount 211 disposed on a distal portion 208 of the flexible substructure 190ʹ. In some embodiments, the magnetic position sensor mount 211 may accommodate a magnetic position sensor 209. For example, the magnetic position sensor mount 211 may define a longitudinal extension slot 213 in which the magnetic position sensor 209 may be disposed.

[0149] In some embodiments, the magnetic position sensor mount 211 can be used as Figure 3A The electrode underlayer structure of the center electrode 130 depicted herein. In some embodiments, the magnetic position sensor 209 may be disposed within the slot 213, and a tubular conductive layer (e.g., the center electrode 130) may be disposed above the outer surface of the magnetic position sensor mount 211.

[0150] In some embodiments, the magnetic position sensor mount 211 may be coupled to the distal coupling 136. In some embodiments, the distal coupling 136 and the magnetic position sensor mount 211 may be formed from a single piece of material. The magnetic position sensor mount 211 may be connected to the distal end of the central frame 192-5, and thus the central frame 192-5 may be connected to the distal coupling 136. In some embodiments, the magnetic position sensor mount 211 may include a keyway 217, which may be configured to receive the distal end of the central frame 192-5, such as... Figure 3S As better depicted. For example, as depicted, the keyway 217 may be a shape complementary to the shape of the distal end of the central frame 192-5. As depicted, the keyway 217 may be a semi-circular groove defined in the magnetic position sensor mount 211.

[0151] The distal end of the central frame 192-5 may include a complementary shape, in this example, a semi-circular end 294. The semi-circular end 294 may be disposed in a keyway 217 to prevent the central frame 192-5 from being pulled proximally from the magnetic position sensor mount 211. This can be advantageous when the flexible underlayer 190' is in a stored state. For example, when the flexible underlayer is disposed in a retracted state within the inlet / sheath, the distance between the first outer arm 126-1 and the second outer arm 126-2 can be reduced, and the distance between the first inner arm 126-2 and the second inner arm 126-3 ( Figure 3A The distance between the slots can be reduced, causing the central frame 192-5 to be pulled further away due to the increased longitudinal length of the flexible substructure 190ʹ. The keyed connection between the slot 217 and the distal end of the central frame 192-5 prevents the central frame 192-5 from being pulled away from the magnetic position sensor mount 211.

[0152] like Figure 3S The description further depicts that a non-invasive tip 292 may be disposed at the distal end of the distal coupling member 136. In some embodiments, the non-invasive tip 292 may be formed of a flexible material (e.g., rubber). When in contact with tissue, the non-invasive tip 292 may cushion the distal coupling member 136. For example, in the case of a location in the cardiac region, when in contact with cardiac tissue, the non-invasive tip 292 may cushion the distal coupling member 136. In some embodiments, the non-invasive tip 292 may be mechanically secured to the distal end of the distal coupling member 136. In some embodiments, the non-invasive tip 292 may be attached to the distal end of the distal coupling member 136 via an adhesive.

[0153] Figure 3T According to embodiments of this disclosure Figure 3J The image depicts a bottom isometric view of the distal portion 208ʹʹ of the flexible substructure 190ʹʹ, which includes an electrode 124, a distal medial substructure conduit 296, and a non-invasive tip 292. As previously discussed, a dual-lumen tube can be disposed above the portion of the inner frame including the electrode 124 to form a first medial arm 126-2 and a second medial arm 126-3. The portions of the lateral and medial arms 126-1, 126-2, 126-3, 126-4 distally positioned from the electrode 124 may include a single lumen tube, such as those depicted relative to the distal lateral substructure conduit 290 and the distal medial substructure conduit 296.

[0154] In some embodiments, the outer and inner arms 126-1, 126-2, 126-3, and 126-4 may include a single-lumen tube covering the entire arm. For example, an electrode 124 may be disposed on the single-lumen tube and the inner and outer frames, and wires electrically coupling the electrode 124 may be disposed within the single lumen. In some embodiments, the outer and inner arms 126-1, 126-2, 126-3, and 126-4 may include a double-lumen tube covering the entire arm. As discussed previously herein, regarding Figure 3A In this case, additional electrodes may be provided on the distal portions of the outer and inner arms 126-1, 126-2, ..., 126-4, as indicated by arrows 156-1, 156-2. Therefore, in some embodiments, the additional electrodes may be provided on the dual-lumen tube.

[0155] like Figure 3S Further described, the magnetic position sensor 209 may include a plurality of coils 219, which, in some embodiments, may be wound around a core 221. In some embodiments, the magnetic position sensor 209 may be covered with an outer layer 223. For example, in some embodiments, the outer layer 223 (e.g., a sleeve and / or coating) may be disposed on the magnetic position sensor 209. In some embodiments, the outer layer 223 may be a heat-shrinkable material. As discussed, the magnetic position sensor 209 may be disposed in a longitudinally extending groove 213, and in some embodiments, the groove may be filled with an adhesive material to prevent the ends of the magnetic position sensor 209 and / or the central frame 192-5 from loosening.

[0156] Figure 3U According to embodiments of this disclosure Figure 3J The image depicts a bottom isometric view of the distal portion 208ʹʹʹ of the flexible substructure 190ʹʹʹ, without the distal coupling 136 and the magnetic position sensor mount 211. The magnetic position sensor 209 is shown in the position it would be positioned if it were located within the magnetic position sensor mount 211. As depicted, the magnetic position sensor 209 can be positioned along the distal portion 208ʹʹʹ of the flexible substructure 190ʹʹʹ.

[0157] As discussed herein, the magnetic position sensor 209 can sense the position and / or orientation that can be provided to the computer system 20. The computer system 20 can use the position and / or orientation sensed by the magnetic position sensor 209 to determine the flexible tip portion 122 ( Figure 3AThe position and / or orientation of the magnetic position sensor 209. As depicted, the magnetic position sensor 209 may be axially aligned with the longitudinal axis of the central frame 192-5. However, in some embodiments, the magnetic position sensor 209 may be tilted relative to the central frame 192-5. For example, the magnetic position sensor 209 may be laterally tilted relative to the longitudinal axis of the central frame 192-5 and / or the flexible tip portion 122 or the catheter axis attached to the flexible tip portion 122. In some embodiments, the magnetic position sensor 209 may be tilted upward or downward relative to the longitudinal axis of the central frame 192-5 and / or the flexible tip portion 122 or the catheter axis attached to the flexible tip portion 122.

[0158] Although the magnetic position sensor 209 is shown positioned along the distal portion 208ʹʹʹ (and specifically, distally from the central frame 192-5), the magnetic position sensor 209 may be disposed at other locations along the flexible underlying structure. In some embodiments, the magnetic position sensor 209 may be positioned relative to its location within the flexible underlying structure. Figure 3U The position depicted is positioned proximal or distal. In some embodiments, the magnetic position sensor 209 can be positioned relative to its location... Figure 3U The position depicted is laterally positioned. For example, in some embodiments, the magnetic position sensor 209 may be positioned at different locations along the distal portion 208ʹʹʹ while still being able to sense the position and / or orientation of the distal portion 208ʹʹʹ.

[0159] In some embodiments, the magnetic position sensor 209 may be positioned along at least one of the first outer frame 192-1 and the second outer frame 192-4 and / or along at least one of the first inner frame 192-2 and the second inner frame 192-3. In some embodiments, the magnetic position sensor may be disposed on one or more of the inner and / or outer frames to determine the position and / or orientation of one of the frames and / or a portion of one of the frames relative to the other frames and / or other portions of one of the frames. Figure 4 The illustration shows embodiments in which a magnetic position sensor is placed at different locations on the distal portion of the flexible tip of the catheter.

[0160] Figure 4 This is a top view of a catheter 300 having a flexible tip portion 302 according to an embodiment of the present disclosure, wherein the flexible tip portion 302 has a pair of magnetic position sensors 304-1, 304-2 disposed on a distal portion of the flexible tip portion 302. The catheter 300 may include a longitudinally extending catheter shaft 306 on which one or more annular electrodes 308-1, 308-2 are disposed. In some embodiments, the annular electrodes 308-1, 308-2 may be used for position sensing, diagnostic, and / or therapeutic purposes. Although regarding... Figure 4One or more ring electrodes 308-1, 308-2 have been discussed, but other embodiments discussed herein (e.g., with respect to Figures 5, 6, and...) Figure 7 The embodiments discussed herein may include the same or similar electrodes. In some embodiments, the flexible tip portion 302 may be coupled to the catheter shaft 306 via a proximal coupling member 310, with a first outer arm 312-1, a second outer arm 312-4, a first inner arm 312-1, and a second inner arm 312-3 extending from the proximal coupling member 310.

[0161] As depicted, multiple electrodes 314 may be disposed on arms 312-1, 312-2, 312-3, and 312-4. Although a total of 16 electrodes 314 are shown on arms 312-1, 312-2, 312-3, and 312-4, the number of electrodes disposed on the arms may be greater than or less than 16. In some embodiments, the multiple electrodes 314 may be used for position sensing, diagnostic, and / or therapeutic purposes. In some embodiments, one or more magnetic position sensors may be disposed on one of the inner and / or outer arms 312-1, 312-2, 312-3, and 312-4. For example, as depicted, a pair of magnetic position sensors 304-1 and 304-2 may be disposed on the distal portions of the first outer arm 312-1 and the second outer arm 312-4. Although the pair of magnetic position sensors 304-1 and 304-2 are shown as being disposed on the distal portions of the first outer arm 304-1 and the second outer arm 304-2, the magnetic position sensors 304-1 and 304-2 may be disposed on other portions of the flexible tip portion 302 (e.g., the first inner arm 312-2 and the second inner arm 312-3).

[0162] In some embodiments, magnetic position sensors 304-1 and 304-2 may be formed via multiple windings made of a first outer arm 312-1 and a second outer arm 312-4, via wires formed of a conductive material (e.g., copper). In some embodiments, multiple windings may be formed on each sensor core 316-1 and 316-2, which may be formed of a magnetically conductive material. For example, in some embodiments, sensor cores 316-1 and 316-2 may be disposed on a portion of one of arms 312-1, 312-2, 312-2, and 312-4, and multiple windings of conductive wires may be formed on sensor cores 316-1 and 316-2.

[0163] In some embodiments, one or more magnetic position sensors may be formed on the underlying structure associated with one of the arms 312-1, 312-2, 312-3, 312-4. For example, although magnetic position sensors 304-1, 304-2 are shown as being disposed around arms 312-1, 312-4, the magnetic position sensors may be disposed on the underlying structure of one or more of the arms 312-1, 312-2, 312-3, 312-4. For example, the underlying structure forming arms 312-1, 312-2, 312-3, 312-4 may include one or more slots in which the magnetic position sensors may be disposed. Alternatively and / or additionally, the magnetic position sensors may be wound around the underlying structure forming one or more arms 312-1, 312-2, 312-3, 312-4.

[0164] In some embodiments, one or more electrodes may be disposed on one or more of the magnetic position sensors 304-1 and 304-2, as per [reference to...]. Figure 3A As discussed herein, for example, in some embodiments, one or more electrodes may define one or more lumens through which the magnetic position sensors 304-1, 304-2 extend. In some embodiments, electrodes may not be disposed over the entirety of the magnetic position sensors 304-1, 304-2. For example, as previously discussed herein, one or more electrodes may be disposed only over a portion (e.g., the top half and / or bottom half) of the magnetic position sensors 304-1, 304-2. In some embodiments, one or more point electrodes may be disposed on one or more magnetic position sensors. In some embodiments, flexible circuitry comprising one or more electrodes disposed thereon may be disposed over one or more magnetic position sensors 304-1, 304-2.

[0165] As depicted, magnetic position sensors 304-1, 304-2 may be formed on a portion of outer arms 312-1, 312-4 diverging relative to a longitudinal axis defined by conduit 300. In some embodiments, magnetic position sensors 304-1, 304-2 may be electrically coupled to computing system 20 via one or more wires 318 (e.g., one or more twisted pairs). As depicted, in some embodiments, wires 318 may not be closed via a lumen (e.g., a double lumen) associated with one of arms 312-1, 312-2, 312-3, 312-4. Wires 318 may extend proximally from each of magnetic position sensors 304-1, 304-2 between a first inner arm 312-2 and a second inner arm 312-3 and along conduit axis 306. In some embodiments, as previously discussed herein, flexible tip portion 302 may include a central arm along which wires 318 may extend.

[0166] In some embodiments, the wire 318 may extend along one of the first outer arm 312-1 and the second outer arm 312-4 and / or the first inner arm 312-2 and the second inner arm 312-3. In some embodiments where the wire travels downward along one or more of the arms 312-1, 312-2, 312-3, 312-4, it is advantageous to maintain symmetry between the arms 312 along which the wire extends. For example, it is advantageous to have one set of wires extend downward along the first outer arm 312-1 and another set of wires extend downward along the second outer arm 312-4; and / or to have one set of wires extend downward along the first inner arm 312-2 and another set of wires extend downward along the second inner arm 312-3. By maintaining symmetry between the arms 312 along which the wire extends, symmetry of the deflection of the arms 312 can be maintained. For example, if the wires associated with the magnetic position sensors 304-1 and 304-2 extend along the first outer arm 312-1 and the first inner arm 312-2, the deflection of the flexible tip portion 302 may become unbalanced due to the increased mechanical stiffness of the side of the flexible tip portion 302 that includes the wires (e.g., the first outer arm 312-1 and the second outer arm 312-2).

[0167] Figure 5A This is an isometric view of a high-density electrode conduit 320 comprising six longitudinally extending arms 322-1, 322-2, ..., 322-6 according to embodiments of the present disclosure. In some embodiments, the high-density electrode conduit 320 may include a flexible tip portion 324 formed by a first outer arm 322-1 and a second outer arm 322-6, a first inner arm 322-3 and a second inner arm 322-4, and a first intermediate arm 322-2 and a second intermediate arm 322-5. As depicted, each of the arms 322-1, 322-2, ..., 322-6 may carry a plurality of electrodes 326. In some embodiments, each of the arms 322-1, 322-2, ..., 322-6 may carry seven electrodes 326, thereby allowing an array of 42 electrodes 326 to be disposed on the flexible tip portion 324. In some embodiments, a larger or smaller number of electrodes 326 may be disposed on the flexible tip portion 324.

[0168] In some embodiments, the flexible tip portion 324 may be coupled to the catheter shaft (not depicted) via a proximal coupling 327. In some embodiments, the proximal ends of arms 322-1, 322-2, ..., 322-6 may be disposed in the proximal coupling 328. The design of the proximal coupling 328 may be related to... Figure 3D The design of the distal coupling head 144 described and discussed is the same. For example, one of the inner arms 322-3 and 322-4 can be set in... Figure 3DIn the depicted lumen 160. In some embodiments, the proximal coupling 328 may include, regarding Figures 3A to 3D Features that are the same as or similar to the remote coupling head 144 are depicted and discussed. In some embodiments, Figure 3D The lumen 160 depicted herein can provide a location for a lower structure associated with one of the inner arms 322-3, 322-4. As previously discussed, each of the arms 322-1, 322-2, ..., 322-6 may include a lower structure on which a tube may be disposed. In some embodiments, the tube disposed on the lower structure may be a double-lumen tube and / or a single-lumen tube.

[0169] In some embodiments, the proximal coupling 328 may include a flushing port (e.g., flushing port 330-1). Although in Figure 5A Only flushing port 330-1 is visible in the image, but in some embodiments, the proximal coupling 328 may include four flushing ports. As depicted, the proximal coupling 328 may connect to the distal end of the connecting rod portion 332, as discussed herein. In some embodiments, the connecting rod portion 332 may include a first magnetic position sensor 334-1 and a second magnetic position sensor (hidden and not visible), each of which may be coupled via sensor cables 335-1, 335-2. In some embodiments, the connecting rod portion 332 may define a first sensor recess 336-1 and a second sensor recess (hidden and not visible).

[0170] As depicted, in some embodiments, the first outer arm 322-1 and the second outer arm 322-6, as well as the first intermediate arm 322-2 and the second intermediate arm 322-5, may extend from the distal end of the proximal coupler 328 along a common plane and may be coupled at their distal ends via the distal coupler 338. In some embodiments, the first inner arm 322-3 may extend below the common plane from the distal end of the proximal coupler 328 toward the distal coupler 338, and the second inner arm 322-4 may extend above the common plane from the distal end of the proximal coupler 328 toward the distal coupler 338, the second inner arm 322-4 engaging with the first inner arm 322-3 at the distal coupler 338. At the distal coupling, the first inner arm 322-3 and the second inner arm 322-4 can be coupled to the first outer arm 322-1 and the second outer arm 322-6, as well as the first intermediate arm 322-2 and the second intermediate arm 322-5. Since the first inner arm 322-3 and the second inner arm 322-4 extend from the proximal coupling 328 on either side of the common plane, the diameter of the proximal coupling 328 can be made more compact. For example, if six frames do not extend distally from the proximal coupling 328 on the common plane, a wider proximal coupling might be required.

[0171] As depicted, each set of arms 322-1, 322-2, ..., 322-6 may extend through mounting cavities 340-1, 340-2, 340-3 defined in the distal coupling 338. Although arms 322-1, 322-2, ..., 322-6 are shown coupled at their distal ends, in some embodiments, arms 322-1, 322-2, ..., 322-6 may not be coupled and may not include the distal coupling 338. As further depicted and discussed herein, arms 322-1, 322-2, ..., 322-6 may include a double-lumen tube (e.g., ...) disposed above a portion of the lower structure (e.g., outer frame 342-1) including the electrode 326. Figure 3K In some embodiments, the single lumen tubes 344, 346 may cover the portion of each of the forming arms 322-1, 322-2, ..., 322-6 of the lower structure where no electrodes are disposed.

[0172] In some embodiments, although not depicted, additional electrodes may be provided along the distal portions of arms 322-1, 322-2, ..., 322-6, as indicated by arrows 348-1, 348-2. For example, although Figure 5A Electrodes 326 are depicted that are linearly aligned with each other along the linear portions of arms 322-1, 322-2, ..., 322-6, but embodiments of this disclosure may benefit from additional electrodes disposed along the regions indicated by arrows 348-1, 348-2 along arms 322-1, 322-2, ..., 322-6.

[0173] Figure 5B It is an embodiment of the present disclosure comprising six longitudinally extending arms 322-1, 322-2, ..., 322-6. Figure 5A The image depicts an isometric view of the high-density electrode conduit 320 facing distally. As depicted, the proximal coupling 327 may include a mounting portion 370, as described above. Figure 3M Further description and discussion. In some embodiments, the proximal coupling 327 may include a manifold portion 372, the manifold portion 372 including components related to... Figure 3F The features discussed in the manifold section 162 described in the text are the same or similar.

[0174] like Figure 5B and Figure 5C As further described, in some embodiments, flexible circuitry 374 may be disposed on one or more portions of arms 322-1, 322-2, ..., 322-6 and / or on the lower structure of one of arms 322-1, 322-2, ..., 322-6. In some embodiments, multiple electrodes may be disposed on flexible circuitry 374 disposed on one or more of arms 322-1, 322-2, ..., 322-6. Figure 5C As depicted, annular electrodes are disposed around each of arms 322-1, 322-2, ..., 322-6. Alternatively and / or additionally, in some embodiments, flexible circuitry may be disposed along one or more of arms 322-1, 322-2, ..., 322-6, and electrodes may be formed on the flexible circuitry. In some embodiments, this may reduce and / or eliminate multiple wires extending through each of arms 322-1, 322-2, ..., 322-6, thereby allowing the use of arms 322-1, 322-2, ..., 322-6 with smaller diameters.

[0175] In some embodiments, the flexible circuit 374 may extend from the proximal end of one or more of arms 322-1, 322-2, ..., 322-6. For example, in Figure 5B and Figure 5C In the diagram, the flexible circuit 374 is shown extending from the proximal end of the second outer arm 322-6 toward the distal end of the second outer arm 322-6. For reference, the flexible circuit 374 is shown disposed on the electrode 326; however, in use, the flexible circuit 374 may replace the electrode 326, and the electrode may be disposed on the flexible circuit 374.

[0176] Although not depicted, in some embodiments, one or more electrical traces may be formed in the flexible circuit 374, and one or more electrodes disposed on the flexible circuit 374 may be electrically coupled to the computer system 20 and / or the computer system 64. In some embodiments, the positions of the electrodes disposed on the flexible circuit 374 may match the positions of the electrodes 326.

[0177] In some embodiments, the flexible circuit 374 may extend along the outer surface of the second outer arm 322-6 and may transition at a transition point 375 to extend along the top and bottom surfaces of the second outer arm 322-6. In some embodiments, a linear flexible circuit may be used by transitioning the flexible circuit 374 from the outer surface of the second outer arm 322-6 to the top and bottom surfaces of the second outer arm 322-6. For example, in some embodiments, the flexible circuit may be disposed entirely along the top and / or bottom surfaces of the second outer arm 322-6. However, due to the curvature in the proximal portion of the second outer arm 322-6, the flexible circuit disposed on the top / bottom surfaces of the second outer arm 322-6 may need to be configured to have a curvature that matches the proximal curved portion of the second outer arm 322-6. Therefore, embodiments of the present disclosure may provide a linearly shaped (e.g., axially extending) flexible circuit 374 disposed along the top and bottom of the second outer arm 322-6 on the curved portion of the second outer arm 322-6.

[0178] like Figure 5D As depicted, the flexible circuit 374 may branch into a top flexible circuit 377-1 and a bottom flexible circuit 377-2 at the transition point 375. In some embodiments, the top flexible circuit 377-1 and the bottom flexible circuit 377-2 may branch from a single flexible circuit 374. However, in some embodiments, the top flexible circuit 377-1 and the bottom flexible circuit 377-2 may be formed from discrete flexible circuits. For example, two separate flexible circuits may extend along the second outer arm 322-6 from the proximal end to the distal end of the second outer arm 322-6. Therefore, the top flexible circuit 377-1 may be formed from a flexible circuit separate from the bottom flexible circuit 377-2. In some embodiments, portions of the flexible circuits near the transition point 375 may overlap each other. Although the second outer arm 322-6 has been discussed above, the other arms 322-1, 322-2, ..., 322-5 of the electrode conduit 320ʹ may also include flexible circuitry and corresponding transition points, as discussed with respect to the second outer arm 322-6.

[0179] In some embodiments, the flexible circuit 374 may extend along the outer surface of the second outer arm 322-6 and may transition at a transition point 375 to extend along either the top or bottom surface of the second outer arm 322-6. For example, in some embodiments, the flexible circuit 374 may extend along either the top or bottom of the second outer arm 322-6. Although the second outer arm 322-6 has been discussed above, the other arms 322-1, 322-2, ..., 322-5 of the electrode conduit 320ʹ may also include flexible circuitry and corresponding transition points, as discussed with respect to the second outer arm 322-6.

[0180] Despite about Figure 5B , Figure 5C and Figure 5D This has been discussed, but flexible circuitry can be implemented in other embodiments discussed herein. For example, at least regarding... Figures 3A to 4 and Figures 6A to 11 The embodiments of this disclosure discussed may include one or more flexible circuits disposed on a flexible tip portion.

[0181] Figure 5C Embodiments according to this disclosure are depicted. Figure 5A The high-density electrode conduit 320ʹ is further illustrated, showing the distal end of the proximal coupling 327 and the frame mounting portions 362-1, 362-2, ..., 362-6. In some embodiments, each arm 322-1, 322-2, ..., 322-6 may include a lower structural frame 342-1, 342-2, 342-3, as discussed herein. For example, refer to... Figure 5CThe various parts of frames 342-1, 342-2, and 342-3 are depicted. As further depicted, the proximal portions of frames 342-1, 342-2, and 342-3 may include frame mounting portions 362-1, 362-2, ..., 362-5 (362-3 and 362-6 are hidden and not visible), as per [the description of...]. Figures 3N to 3P The frame mounting sections 362-1, 362-2, ..., 362-6 can be set in mounting section 176, as discussed above. Figure 3M Further description. In some embodiments, with can be with Figure 5A The same mounting portion 176 used with the catheter 320 depicted herein can be used Figure 3A The catheter 120 depicted includes five longitudinal extension arms, and the catheter 320 includes six longitudinal extension arms.

[0182] In some embodiments, the frame mounting portion 362-4 associated with the second inner arm 322-4 may include a... Figure 3O The frame mounting portion 206-5 depicted in the figure has the same features and can be inserted into the mounting cavity (e.g., Figure 3M In the mounting cavity 269 depicted herein. In some embodiments, the frame mounting portion (hidden and not visible) associated with the first inner arm 322-4 may include a mounting portion with... Figure 3O The frame mounting portion 206-5 depicted in the figure has the same features and can be inserted into the mounting cavity (e.g., Figure 3M The installation cavity 275 is depicted in the text.

[0183] although Figures 5A to 5D One or more magnetic position sensors are not shown on the device depicted, but in some embodiments, one or more magnetic position sensors may be provided on the device. For example, in some embodiments, a device having six longitudinally extending arms may include one or more magnetic position sensors disposed thereon. In some embodiments, the magnetic position sensors may be disposed on a portion of the first outer arm 322-1 and the second outer arm 322-6. For example, in some embodiments, the magnetic position sensors may be positioned relative to... Figure 4 The configurations depicted and discussed are similar to those provided on the distal portions of the first outer arm 322-1 and the second outer arm 322-6. In some embodiments, one or more magnetic position sensors may be used in conjunction with... Figure 4 The configurations depicted and discussed are similar to those provided on one or more of the distal portions of the first intermediate arm 322-2 and the second intermediate arm 322-5. In some embodiments, one or more magnetic position sensors may be used in conjunction with... Figure 4The configurations depicted and discussed are similar to those provided on one or more of the distal portions of the first inner arm 322-3 and the second inner arm 322-4.

[0184] Figure 6A This is an isometric view of the lower structure 378 of the flexible tip 380 of a high-density electrode conduit according to an embodiment of the present disclosure. As depicted, the flexible tip 380 may include a first outer frame 382-1, a second outer frame 382-7, a first intermediate frame 382-2, a second intermediate frame 382-6, a first inner frame 382-3, a second inner frame 382-5, and a central frame 382-4. In addition to the additional first intermediate frame 382-2 and second intermediate frame 382-6, the flexible tip 380 may include, with respect to… Figure 3A The high-density electrode conduit 120 has similar or identical features to those discussed. (See also: regarding...) Figure 6B Further description and discussion can be made using the near-end mounting portion 394, which can be used to set all seven frames 382-1, 382-2, ..., 382-7.

[0185] As further described, the central frame 382-4 may include a non-linear extension feature 384, as previously discussed herein. The non-linear extension feature 384 allows the central frame 382-4 to extend in response to the flexible tip 380 being in a stored (e.g., retracted) configuration, as discussed herein. In some embodiments, the distal end of the central arm 382-4 may be connected to the magnetic position sensor mount 386 via a keyway 388 and a corresponding keyed distal end (hidden and not visible) of the central frame 382-4.

[0186] In some embodiments, a magnetic position sensor (not depicted) may be disposed in a longitudinally extending slot 390 defined in a magnetic position sensor mount 386, thereby allowing the determination of the position and orientation of the distal end of the flexible tip 380. In some embodiments, as previously discussed herein, a conductive sheath may be disposed over the magnetic position sensor mount 386, which may serve as an electrode. As further depicted, in some embodiments, the magnetic position sensor mount 386 may be coupled to a distal coupling member 392, which may couple to the distal end of each of frames 382-1, 382-2, ..., 382-7. As discussed herein, in some embodiments, coupling members may not be used, and frames 382-1, 382-2, ..., 382-7 may be freely disposed relative to each other.

[0187] In some embodiments, the proximal mounting portion 394 may define an insertion lumen (e.g., insertion lumen 396) for the proximal mounting portions (not depicted) of each of the frames 382-1, 382-2, ..., 382-7. In some embodiments, a wire lumen (e.g., wire lumen 398) may be defined adjacent to each insertion lumen 396, thereby allowing wires associated with one or more electrical sensors (e.g., electrodes) or other devices disposed on the underlying structure 378 to pass through the wire lumen.

[0188] Figure 6B According to embodiments of this disclosure Figure 6A A proximal view of the depicted proximal mounting portion 394. In some embodiments, the proximal mounting portion 394 may be disposed on the distal end of a catheter shaft (not depicted). In some embodiments, a plurality of insertion lumens 396 are defined in the distal face of the proximal mounting portion 394. For simplicity, the discussion of insertion lumens will be limited to insertion lumen 396. (See also: Regarding...) Figure 3N and Figure 3P Regarding the five-arm flexible tip portion discussed, the proximal mounting portion of each of the frames can be inserted into a corresponding one of the insertion lumens 396. For example, the proximal mounting portion of the first intermediate frame 382-3 may include, with respect to... Figures 3N to 3P The discussed center mounting portion 206-5 has similar or identical spring clip features. Therefore, the proximal mounting portion 394 of the first intermediate frame 382-3 can be pushed proximally through the insertion lumen 396, thereby allowing the proximal mounting portion of the first intermediate frame 382-3 to lock in place relative to the proximal mounting portion 394. (See also: Regarding...) Figure 6B As depicted, the near-end mounting portion 394 may include seven insertion lumens and seven wiring lumens 398 to accommodate each of the frames 382-1, 382-2, ..., 382-7 and the associated wiring.

[0189] Figure 7 The distal flexible tip portion 400 of a high-density electrode conduit with a specific electrode configuration according to an embodiment of the present disclosure is depicted. As depicted, the distal flexible tip portion 400 includes a first outer arm 402-1, a first inner arm 402-2, a central arm 402-3, a second inner arm 402-4, and a second outer arm 402-5, all coupled via a distal coupling member 403. As depicted, a plurality of electrodes 404-1, 404-2, ..., 404-19 may be disposed on each of the arms 402-1, 402-2, ..., 402-5. As depicted, the spacing indicated by dashed lines 406 between each lateral row of electrodes 404-1, 404-5, 404-12, 404-19 may have equal spacing between each electrode 404-1, 404-5, 404-12, 404-19.

[0190] In some embodiments, the spacing between electrodes 404 in each lateral row of electrodes can be in the range of 3 to 5 mm. In some embodiments, the spacing between electrodes 404 in each lateral row of electrodes 404 can be 4 mm. As depicted, electrodes 404-9, 404-10, and 404-11 disposed on the central arm 404-3 can be longitudinally staggered relative to the electrodes disposed on the first outer arm 404-1 and the second outer arm 404-5, and the first inner arm 404-2 and the second inner arm 404-4. In some embodiments, electrodes 404-9, 404-10, and 404-11 disposed on the central arm 404-3 can be longitudinally staggered relative to the electrodes disposed on the first outer arm 404-1 and the second outer arm 404-5, and the first inner arm 404-2 and the second inner arm 404-4 for a length ranging from 1 to 3 mm. In some embodiments, the staggered length can be 2 mm.

[0191] In some embodiments, the electrodes disposed on the central arm 404-3 and the electrodes disposed on the first inner arm 404-2 and the second inner arm 404-4 may form a pattern with decreasing spacing, as indicated by the dashed box 408. In some embodiments, the spacing length between each electrode 404-6, 404-10, 404-11, 404-13 intersecting with the dashed box 408 may be in the range of 1.5 to 3.5 mm. In some embodiments, the spacing length may be 2.8 mm. Although specific ranges are provided herein, these ranges may be approximate, and the spacing between electrodes may be less than or greater than the provided range.

[0192] As in Figure 7 Further described herein, an additional electrode 410 may be disposed at the distal end of the central arm 404-3. As previously discussed herein, the additional electrode 410 may be used for diagnostic, mapping, and / or therapeutic purposes. In some embodiments, as further discussed herein, a magnetic position sensor may be disposed within the additional electrode 410 to provide mapping capability for the distal flexible tip portion 400.

[0193] Figures 8A to 8E Various electrode spacing configurations of electrodes disposed on the distal flexible tip portion of a high-density electrode conduit according to embodiments of the present disclosure are depicted. Regarding... Figures 8A to 8E The overall dimensions (e.g., a × b) represented by lines "a" and "b" can be the same. However, the density and configuration of the electrode spacing can vary. Although specific ranges are provided herein, regarding... Figures 8A to 8E This range can be approximate, and the spacing between electrodes can be smaller or larger than the provided range. In some embodiments, although regarding Figures 8A to 8EA specific number of electrodes is depicted, but the embodiments described herein may include more or fewer electrodes than those depicted.

[0194] like Figure 8A As depicted, a flexible frame 420 formed by multiple arms 422-1, 422-2, 422-3, and 422-4 (including a first outer arm 422-1, a first inner arm 422-2, a second inner arm 422-3, and a second outer arm 422-4) is provided with multiple electrodes 424-1, 424-2, and 424-3. For ease of reference, only electrodes 424-1, 424-2, and 424-3 are referred to herein; however, the principles discussed regarding electrodes 424-1, 424-2, and 424-3 also apply. Figure 8A Other electrodes depicted in the image. For example... Figure 8A As depicted, 16 electrodes can be placed on the flexible frame.

[0195] In some embodiments, the spacing between each of the horizontally spaced electrodes may be equal. As used herein, the terms “horizontally spaced” and “horizontal spacing” may be used interchangeably with the terms “laterally spaced” and “lateral spacing,” respectively. For example, the spacing between electrodes 424-1, 424-3 may be equal to the spacing between other horizontally spaced electrodes disposed on the flexible frame 420. In some embodiments, the spacing between each of the horizontally spaced electrodes (e.g., electrodes 424-1, 424-3) may be in the range of 2 to 5 millimeters. In some embodiments, the spacing between each of the horizontally spaced electrodes (e.g., electrodes 424-1, 424-3) may be 4 millimeters.

[0196] In some embodiments, the spacing between each of the vertically spaced electrodes may be equal. As used herein, the terms “vertically spaced” and “vertical spacing” may be used interchangeably with the terms “longitudinal spacing” and “longitudinal spacing,” respectively. For example, the spacing between electrodes 424-1, 424-2 may be equal to the spacing between other vertically spaced electrodes disposed on the flexible frame 420. In some embodiments, the spacing between each of the vertically spaced electrodes (e.g., electrodes 424-1, 424-2) may be in the range of 2 to 5 millimeters. In some embodiments, the spacing between each of the vertically spaced electrodes (e.g., electrodes 424-1, 424-2) may be 4 millimeters.

[0197] like Figure 8BAs depicted, a flexible frame 426 formed by multiple arms 428-1, 428-2, ..., 428-5 (including a first outer arm 428-1, a first inner arm 428-2, a central arm 428-3, a second inner arm 428-4, and a second outer arm 428-5) is provided with multiple electrodes 430-1, 430-2, ..., 430-11. In some embodiments, a higher density of electrodes can be provided on the first inner arm 428-2, the central arm 428-3, and the second inner arm 428-4. For ease of reference, only electrodes 424-1, 424-2, ..., 424-9 are referred to herein; however, the principles discussed regarding electrodes 424-1, 424-2, ..., 424-9 also apply. Figure 8B Other electrodes depicted in the image. For example... Figure 8B As depicted, 29 electrodes can be placed on the flexible frame.

[0198] In some embodiments, the spacing between each of the horizontally spaced electrodes (e.g., electrodes 430-1, 430-2, 430-4, 430-5) disposed on the first outer arm 428-1, the first inner arm 428-2, the second inner arm 428-4, and the second outer arm 428-5 may be equal. In some embodiments, the spacing between each of the horizontally spaced electrodes (e.g., 424-1, 424-3) may be in the range of 2 to 5 mm. In some embodiments, the spacing between each of the horizontally spaced electrodes (e.g., 424-1, 424-3) may be 4 mm.

[0199] In some embodiments, the spacing between each electrode in the vertically spaced electrodes (e.g., electrodes 430-1, 430-8) on the first outer arm 428-1 and the second outer arm 428-5 can be equal. In some embodiments, although a higher density of electrodes is provided on the first inner arm 428-2, the second inner arm 428-4, and the central arm 428-3, the spacing between each electrode in the vertically spaced electrodes (e.g., electrodes 430-1, 430-8) on the first outer arm 428-1 and the second outer arm 428-5 can be maintained as the spacing between specific electrodes (e.g., electrodes 430-2, 430-9) provided on the first inner arm 428-2, the central arm 428-3, and the second inner arm 428-4. For example, the spacing between electrodes 430-2 and 430-9 provided on the second inner arm 428-4 can be equal to the spacing between electrodes 430-1 and 430-8 provided on the second outer arm 428-5. In some embodiments, the spacing between each of the vertically spaced electrodes (e.g., 430-1, 430-8) can be in the range of 2 to 5 millimeters. In some embodiments, the spacing between each of the vertically spaced electrodes (e.g., 424-1, 424-8) can be 4 millimeters.

[0200] In some embodiments, the spacing between electrodes (e.g., electrodes 430-2, 430-3, 430-6, 430-7) disposed on the first inner arm 428-2, the second inner arm 428-4, and the central arm 428-3 may include a smaller spacing between electrodes (e.g., electrodes 430-1, 430-8) disposed on the first outer arm 428-1 and the second outer arm 428-5, thereby resulting in a higher electrode density disposed on the first inner arm 428-2, the central arm 428-3, and the second inner arm 428-3. In some embodiments, the higher density of electrodes disposed on the first inner arm 428-2, the central arm 428-3, and the second inner arm 428-3 can form a flexible frame 426 that provides a larger sensing granularity. In some embodiments where ablation is performed using electrodes, the higher density of electrodes disposed on the first inner arm 428-2, the central arm 428-3, and the second inner arm 428-3 can provide a denser ablation pattern.

[0201] In some embodiments, the spacing between each of the vertically spaced electrodes (e.g., electrodes 430-2, 430-6 and electrodes 430-3, 430-7) disposed on the first inner arm 428-2, the central arm 428-3, and the second inner arm 428-3 can be in the range of 1 to 3 mm. In some embodiments, the spacing between each of the vertically spaced electrodes (e.g., electrodes 430-2, 430-6 and electrodes 430-3, 430-7) can be 2 mm. In some embodiments, the spacing between each of the horizontally spaced electrodes (e.g., electrodes 430-3, 430-2 and electrodes 430-7, 430-6) disposed on the first inner arm 428-2, the central arm 428-3, and the second inner arm 428-4 can be in the range of 1 to 3 mm. In some embodiments, the spacing between each of the horizontally spaced electrodes (e.g., electrodes 430-3, 430-2 and electrodes 430-7, 430-6) can be 2 mm.

[0202] In some embodiments, a first plurality of electrodes (e.g., electrodes 430-1, 430-2, 430-4, 430-5, 430-8, 430-9, 430-10, 430-11) may be disposed on the first outer arm 428-1 and the second outer arm 428-5, the first inner arm 428-2 and the second inner arm 428-4, and the electrodes may have equal spacing between them. In the example, the spacing between each of the electrodes 430-1, 430-2, 430-4, 430-5, 430-8, 430-9, 430-10, and 430-11 may be a first dimension (e.g., 2 mm). In some embodiments, a second plurality of electrodes (e.g., electrodes 430-2, 430-3, 430-6, 430-7) may be disposed on the first inner arm 428-2, the second inner arm 428-4, and the central arm 428-3, and these electrodes may have equal spacing between them. In the example, the spacing between each of electrodes 430-2, 430-3, 430-6, and 430-7 may be a second size (e.g., 1 mm). In some embodiments, the second size may be smaller than the first size, thereby allowing for a higher electrode density disposed on the first inner arm 428-2, the second inner arm 428-4, and the central arm 432.

[0203] As further depicted, the flexible frame 426 may include a magnetic position sensor 432 disposed on the distal portion of the central arm 428-3. In some embodiments, the position of the magnetic position sensor 432 may be determined, and thus the position of the distal portion of the flexible frame 426 may be determined. The magnetic position sensor 432 may be a five-degree-of-freedom sensor and / or a six-degree-of-freedom sensor. Although the magnetic position sensor 432 is shown disposed on the central arm 428-3, the magnetic position sensor 432 may be disposed on other portions of the flexible frame. In some embodiments, the magnetic position sensor 432 is not limited to a single magnetic position sensor and may include more than one magnetic position sensor. In some embodiments, as previously discussed herein, the magnetic position sensor 432 may be disposed in a magnetic position sensor mount that also acts as an additional electrode. Thus, in some embodiments, the flexible frame 426 may include 30 electrodes.

[0204] like Figure 8C As depicted, a flexible frame 438 formed by multiple arms 440-1, 440-2, ..., 440-5 (including a first outer arm 440-1, a first inner arm 440-2, a central arm 440-3, a second inner arm 440-4, and a second outer arm 440-5) is provided with multiple electrodes 442-1, 442-2, 442-3. In some embodiments, the multiple arms 440-1, 440-2, ..., 440-5 may include electrodes 442-1, 442-2, 442-3 of equal density. For ease of reference, only electrodes 442-1, 442-2, and 442-3 are referred to herein; however, the principles discussed regarding electrodes 440-1, 440-2, and 440-3 also apply. Figure 8C Other electrodes depicted in the image. For example... Figure 8C As depicted, 25 electrodes can be placed on the flexible frame.

[0205] In some embodiments, the spacing between each of the horizontally spaced electrodes can be equal. For example, the spacing between electrodes 442-1 and 442-3 can be equal to the spacing between other horizontally spaced electrodes disposed on the flexible frame 438. In some embodiments, the spacing between each of the horizontally spaced electrodes (e.g., electrodes 442-1 and 442-3) can be in the range of 2 to 4 mm. In some embodiments, the spacing between each of the horizontally spaced electrodes (e.g., electrodes 442-1 and 442-3) can be 3 mm. In some embodiments, the spacing between each of the vertically spaced electrodes can be equal. For example, the spacing between electrodes 442-1 and 442-2 can be equal to the spacing between other vertically spaced electrodes disposed on the flexible frame 438. In some embodiments, the spacing between each of the vertically spaced electrodes (e.g., electrodes 442-1 and 442-2) can be in the range of 2 to 4 mm. In some embodiments, the spacing between each of the vertically spaced electrodes (e.g., electrodes 442-1 and 442-2) can be 3 mm.

[0206] As further described, the flexible frame 438 may include a magnetic position sensor 444 disposed on the distal portion of the central arm 440-3. In some embodiments, the magnetic position sensor 444 may be used to determine the position and orientation of the distal portion of the flexible frame. The magnetic position sensor 444 may be a five-degree-of-freedom (DOF) sensor and / or a six-degree-of-freedom (DOF) sensor. In some embodiments, as previously discussed herein, the magnetic position sensor 444 may be disposed in a magnetic position sensor mount that also functions as an additional electrode. Thus, in some embodiments, the flexible frame 438 may include 30 electrodes.

[0207] like Figure 8D As depicted, a flexible frame 450 formed by multiple arms 452-1, 452-2, ..., 422-6 (including the first outer arm 452-1, the first intermediate arm 452-2, the first inner arm 452-3, the second outer arm 452-4, the second intermediate arm 452-5, and the second outer arm 452-6) is provided with multiple electrodes 454-1, 454-2, and 454-3. For ease of reference, only electrodes 454-1, 454-2, and 454-3 are referred to in this document; however, the principles discussed regarding electrodes 454-1, 454-2, and 454-3 also apply. Figure 8D Other electrodes depicted in the image. For example... Figure 8D As depicted, 36 electrodes can be mounted on the flexible frame 450.

[0208] In some embodiments, the spacing between each of the horizontally spaced electrodes may be equal. For example, the spacing between electrodes 454-1 and 454-3 may be equal to the spacing between other horizontally spaced electrodes disposed on the flexible frame 450. In some embodiments, the spacing between each of the horizontally spaced electrodes (e.g., electrodes 454-1 and 454-3) may be in the range of 1.4 to 3.4 mm. In some embodiments, the spacing between each of the horizontally spaced electrodes (e.g., electrodes 454-1 and 454-3) may be 2.4 mm.

[0209] In some embodiments, the spacing between each of the vertically spaced electrodes may be equal. For example, the spacing between electrodes 454-1 and 454-2 may be equal to the spacing between other vertically spaced electrodes disposed on the flexible frame 450. In some embodiments, the spacing between each of the vertically spaced electrodes (e.g., electrodes 454-1 and 454-2) may be in the range of 1.4 to 3.4 mm. In some embodiments, the spacing between each of the vertically spaced electrodes (e.g., electrodes 454-1 and 454-2) may be 2.4 mm.

[0210] like Figure 8E As depicted, a flexible frame 460 formed by multiple arms 462-1, 462-2, ..., 462-7 (including the first outer arm 462-1, the first intermediate arm 462-3, the first inner arm 463-3, the central arm 462-4, the second inner arm 462-5, the second intermediate arm 462-6, and the second outer arm 462-7) is provided with multiple electrodes 462-1, 462-2, and 462-3. For ease of reference, only electrodes 462-1, 462-2, and 462-3 are referred to in this document; however, the principles discussed regarding electrodes 462-1, 462-2, and 462-3 also apply. Figure 8E Other electrodes depicted in the image. For example... Figure 8E As depicted, 49 electrodes can be set on the flexible frame 460.

[0211] In some embodiments, the spacing between each of the horizontally spaced electrodes may be equal. For example, the spacing between electrodes 464-1 and 464-3 may be equal to the spacing between other horizontally spaced electrodes disposed on the flexible frame 460. In some embodiments, the spacing between each of the horizontally spaced electrodes (e.g., electrodes 464-1 and 464-3) may be in the range of 1 to 3 mm. In some embodiments, the spacing between each of the horizontally spaced electrodes (e.g., electrodes 464-1 and 464-3) may be 2 mm. In some embodiments, the spacing between each of the vertically spaced electrodes may be equal. For example, the spacing between electrodes 464-1 and 464-2 may be equal to the spacing between other vertically spaced electrodes disposed on the flexible frame 460. In some embodiments, the spacing between each of the vertically spaced electrodes (e.g., electrodes 464-1 and 464-2) may be in the range of 0.5 to 3 mm. In some embodiments, the spacing between each of the vertically spaced electrodes (e.g., electrodes 464-1 and 464-2) may be 2 mm.

[0212] As further described, the flexible frame 460 may include a magnetic position sensor 466 disposed on the distal portion of the central arms 462-4. In some embodiments, the magnetic position sensor 466 may be used to determine the position and orientation of the distal portion of the flexible frame. The magnetic position sensor 466 may be a five-degree-of-freedom sensor and / or a six-degree-of-freedom sensor. In some embodiments, as previously discussed herein, the magnetic position sensor 466 may be disposed in a magnetic position sensor mount that also acts as an additional electrode. Thus, in some embodiments, the flexible frame 438 may include 50 electrodes.

[0213] Figure 9 This is an isometric rear view of a distal tip assembly 480 including a magnetic position sensor mount 486 and a distal coupling member 482 according to embodiments of the present disclosure. As depicted, the distal coupling member 482 may define one or more lateral lumens 484-1, 484-2 extending therethrough, as discussed herein. One or more arms (not depicted) associated with a flexible frame may be configured to extend through one or more lateral lumens 484-1, 484-2. In some embodiments, the magnetic position sensor mount 486 may extend from the distal coupling member 482 towards the proximal end. In some embodiments, the magnetic position sensor mount 486 may include a first sensor recess 488-1 and a second sensor recess 488-2 defined in an outer surface 490 of the magnetic position sensor mount 486. Figure 9In some embodiments, the first sensor recess 488-1 and the second sensor recess 488-2 may be angled relative to each other and / or relative to the longitudinal axis of the magnetic position sensor mount 486. In some embodiments, the first sensor recess 488-1 and the second sensor recess 488-2 and in Figure 10 The magnetic position sensors further depicted in the first sensor recess 488-1 and the second sensor recess 488-2 may include those features discussed with respect to U.S. Patent Application No. 15 / 585,859, which is incorporated herein by reference as if fully set forth herein.

[0214] For example, in some embodiments, when the magnetic position sensors are disposed in the first sensor recess 488-1 and the second sensor recess 488-2, the magnetic position sensors can be tilted relative to each other. This allows the determination of the roll of the magnetic position sensor mount 486 and the associated distal coupling 482, and thus the roll of the flexible frame connected to the distal coupling 482 and / or the magnetic position sensor mount 486.

[0215] Although the magnetic position sensor mount 486 is shown connected to the distal coupling 482, the magnetic position sensor mount 486 may be positioned along other portions of the flexible frame of the high-density electrode conduit, as discussed herein. For example, the magnetic position sensor mount 486 and the associated magnetic position sensor may be positioned along the central arm, inner arm, intermediate arm, and / or outer arm, as discussed herein.

[0216] As further discussed herein, in some embodiments, the magnetic position sensor mount 486 may form electrodes. In some embodiments, a conductive material (not depicted) may surround the magnetic position sensor mount 486, which may form electrodes. For example, the central electrode 130 (e.g., regarding at least...) Figure 3A The central electrode 130 described and discussed can be disposed on the magnetic position sensor mount 486.

[0217] Figure 10This is a side view of a distal tip assembly 500 including a magnetic position sensor mount 506 and a distal coupling member 502 according to embodiments of the present disclosure. As depicted, the distal coupling member 502 may define one or more lateral lumens 504-1, 504-2 extending therethrough, as discussed herein. One or more arms (not depicted) associated with a flexible frame may be configured to extend through one or more lateral lumens 504-1, 504-2. In some embodiments, the magnetic position sensor mount 506 may extend from the distal coupling member 502 towards the proximal end. In some embodiments, the magnetic position sensor mount 506 may include a first sensor recess 508-1 and a second sensor recess 508-2 defined in an outer surface 510 of the magnetic position sensor mount 506. Figure 9 In some embodiments, the first sensor recess 508-1 and the second sensor recess 508-2 may be angled relative to each other and / or relative to the longitudinal axis of the magnetic position sensor mount 506. In some embodiments, the first sensor recess 508-1 and the second sensor recess 508-2, as well as the magnetic position sensor 512-1 disposed in the first sensor recess 508-1 and the second sensor recess 508-2 (the sensor recess 508-2 is hidden and not visible), may include those features discussed with respect to U.S. Patent Application No. 15 / 585,859, which is incorporated herein by reference as if fully set forth herein.

[0218] For example, in some embodiments, when the magnetic position sensors 512-1 and 512-2 are disposed in the first sensor recess 508-1 and the second sensor recess 508-2, the magnetic position sensors 512-1 and 512-2 may be tilted relative to each other. This allows the determination of the rolling of the magnetic position sensor mount 506 and the associated distal coupling 502, and thus the rolling of the flexible frame connected to the distal coupling 502 and / or the magnetic position sensor mount 506.

[0219] Although the magnetic position sensor mount 506 is shown connected to the distal coupling 502, the magnetic position sensor mount 506 may be positioned along other portions of the flexible frame of the high-density electrode conduit, as discussed herein. For example, the magnetic position sensor mount 506 and the associated magnetic position sensor may be positioned along the central arm, inner arm, intermediate arm, and / or outer arm, as discussed herein.

[0220] like Figure 10 As depicted, the first twisted pair 514-1 and the second twisted pair 514-2 can electrically couple the magnetic position sensors 512-1 and 512-2 to... Figure 1A and Figure 1BOne or more of the computer systems 20 and 64 described herein. (As in...) Figure 10 Further depiction shows that electrode wire 518 is shown extending from the proximal end of magnetic position sensor mount 506, and electrode wire 518 can be electrically coupled to one or more electrodes disposed on magnetic position sensor mount and computer systems 20, 64. A central frame 516 of a flexible frame is also shown extending from the proximal end of magnetic position sensor mount, as discussed herein. In some embodiments, central frame 516 can be coupled to the proximal end of magnetic position sensor mount 506, as described herein, for example, regarding... Figure 3J and Figure 3S The discussion.

[0221] Figure 11 This is a top view of a high-density electrode conduit 530 having staggered electrodes 534-1, 534-2, ..., 534-25 according to embodiments of the present disclosure. As depicted, the high-density electrode conduit 530 may include a flexible frame formed by a first outer arm 532-1, a first inner arm 532-2, a central arm 532-3, a second inner arm 532-4, and a second outer arm 532-5. In some embodiments, the proximal ends of the arms 532-1, 532-2, ..., 532-5 may be disposed in a proximal coupling member 536, which, as discussed herein, may be mounted on the distal end of a conduit shaft (not depicted). The distal ends of the arms 532-1, 532-2, ..., 532-5 may be fitted with a distal coupling member 538. However, in some embodiments, the arms 532-1, 532-2, ..., 532-5 may not be coupled to each other.

[0222] As depicted, the central arm 532-3 may include an extension feature 540 as discussed herein. In some embodiments, the central arm 532-3 may include an electrode 542 disposed at a distal end of the central arm 532-3. In some embodiments, the core of the electrode 542 may include a magnetic position sensor (not depicted) for determining the position and / or orientation of the flexible frame 531.

[0223] In some embodiments, as depicted, each of arms 532-1, 532-2, ..., 532-5 may include electrodes 534-1, 534-2, ..., 534-25 disposed thereon. As depicted, the electrodes on each of arms 532-1, 532-2, ..., 532-5 may be staggered relative to each other. For example, electrodes 534-1, 534-2, ..., 534-5 with respect to the first outer arm 532-1 may be staggered relative to electrodes 534-6, 534-7, ..., 534-10 disposed on the first inner arm 532-2. As depicted, electrodes 534 disposed on each arm may be staggered relative to electrodes 534 disposed on each adjacent arm.

[0224] In some embodiments, the electrodes 534 disposed on the first inner arm 532-2 and the electrodes 534 disposed on the first outer arm 532-1 and the central arm 532-3 may form clusters (e.g., groups) of electrodes 534; the electrodes 534 disposed on the central arm 532-3 and the electrodes 534 disposed on the first inner arm 532-2 and the second inner arm 532-4 may form clusters of electrodes 534; and / or the electrodes 534 disposed on the second inner arm 532-4 and the electrodes 534 disposed on the central arm 532-3 and the second outer arm 532-5 may form clusters of electrodes 534. For example, with respect to the first outer arm 532-1, the first inner arm 532-2, and the central arm 532-3, the clusters of electrodes 534-1, 534-6, 534-7, and 534-11 are represented by parallelograms 544.

[0225] In some embodiments, it may be advantageous to stagger the electrodes 534-1, 534-2, ..., 534-25 disposed on each of the arms 532-1, 532-2, ..., 532-5, as this provides a trade-off between the spacing between each of the electrodes 534-1, 534-2, ..., 534-25 and the total number of electrodes 534-1, 534-2, ..., 534-25. In the example, the spacing between each electrode in the cluster of electrodes 543-1, 534-6, 534-7, 534-11 may be the same. For example, the spacing between electrodes 534-1 and 534-7 may be the same as the spacing between electrodes 534-1 and 534-6, and the spacing between electrodes 534-1 and 534-6 may be the same as the spacing between electrodes 534-6 and 534-7. Regarding Figure 11 The depicted and discussed embodiments allow for a reduced spacing between electrodes 534 while using the same number of electrodes as in embodiments where electrodes 534-1, 534-2, ..., 534-25 are not interlaced. In some embodiments where the electrodes are not interlaced but aligned with each other along the longitudinal and transverse axes of the flexible tip portion, a greater number of electrodes and / or more arms may be required to make the spacing between a set of interlaced electrodes equal, for example, regarding Figure 11 The intervals depicted.

[0226] Figure 12A This is a top view of a lower structure 548 of the flexible tip of a high-density electrode conduit according to an embodiment of the present disclosure, including magnetic position sensors 554-1, 554-2 located in an outer frame. As depicted, the lower structure 548 may include a first outer frame 550-1 and a second outer frame 550-2. In some embodiments, Figure 12A A portion of the entire underlying structure associated with the flexible tip of the high-density electrode conduit is depicted. For example, Figure 12AThe outer substructure portion of the entire substructure is depicted, which may also include an intermediate frame and / or an inner frame, as further discussed herein. For example, the substructure to which the first outer frame 550-1 and the second outer frame 550-2 belong may have a total of two to eight arms; however, in some embodiments, embodiments of this disclosure may include more than eight arms. As depicted, the first frame 550-1 and the second frame 550-2 may include frame mounting portions 552-1, 552-2.

[0227] In some embodiments, magnetic position sensors 554-1 and 554-2 can be arranged along the first outer frame 550-1 and the second outer frame 550-2, such as... Figure 12A As depicted in the figure. In some embodiments, magnetic position sensors 554-1, 554-2 may be disposed along the top, bottom, interior and / or exterior of each of the first outer frame 550-1 and the second outer frame 550-2. In some embodiments, the first outer frame 550-1 and the second outer frame 550-2 may include mounting features configured to allow mounting of magnetic position sensors 554-1, 554-2 along the first outer frame 550-1 and the second outer frame 550-2.

[0228] In some embodiments, as depicted, the first outer frame 550-1 and the second outer frame 550-2 may include slots 556-1, 556-2 defined along longitudinally extending portions of the first outer frame 550-1 and the second outer frame 550-2. As depicted, in some embodiments, slots 556-1, 556-2 define a central mounting space that extends longitudinally along the first outer frame 550-1 and the second outer frame 550-2. As depicted, slots 556-1, 556-2 and associated magnetic position sensors 554-1, 554-2 are shown positioned proximal to shoulder portions 558-1, 558-2. In some embodiments, magnetic position sensors 554-1, 554-2 may be positioned along other portions of the first outer frame 550-1 and the second outer frame 550-2. For example, magnetic position sensors 554-1, 554-2 may be positioned along the outer frames 550-1, 550-2 from... Figure 12A The positions depicted are positioned proximally. In some embodiments, magnetic position sensors 554-1, 554-2 may be located in the proximal tip portion 560 of the outer lower structure. Although two magnetic position sensors 554-1, 554-2 are shown arranged along the outer frame 550-1, 550-2, fewer or more magnetic position sensors 554-1, 554-2 may be arranged along the outer frame 550-1, 550-2.

[0229] In some embodiments, as discussed, slots 556-1, 556-2 may be defined within a portion of the first outer frame 550-1 and the second outer frame 550-2. With regard to the second slot 556-2, the second slot 556-2 may be defined along the second outer frame 550-2 such that a pair of slot frames 562-1, 562-2 define the slot 556-2. For example, in some embodiments, the second outer frame 550-2 may be cut to define the slot 556-2, leaving the first slot frame 562-1 and the second slot frame 562-2. In some embodiments, the portion of the outer frame 550-2 defining the slot 556-2 may be widened such that when material is removed from the outer frame 550-2 to define the slot 556-2, the combined lateral width of each slot frame 562-1, 562-2 may match the lateral width of the outer frame 550-2. As can be seen, this portion of the outer frame 550-2 includes a flare 564, such that the portion of the outer frame 550-2 including the magnetic position sensor 554-2 is wider than the other longitudinal extensions of the outer frame 550-2. In some embodiments, the total lateral width of the slot frames 562-1, 562-2 may be less than or greater than the lateral width of the other longitudinal extensions of the outer frame 550-2, for example, the longitudinal extensions of the outer frame 550-2 located near the proximal ends of the slot frames 562-1, 562-2. Therefore, even though the outer frame 550-2 defines the slot 556-2, the flexibility of the portion of the outer frame 550-2 including the magnetic position sensor can match or nearly match the flexibility of the other longitudinal extensions of the outer frame 550-2 (e.g., those longitudinal extensions located near the proximal ends of the magnetic position sensor 554-2). Although the above discussion pertains to the second outer frame 550-2, this can also be the case for other frames.

[0230] As depicted, the magnetic position sensor 554-2 may be located between the slot frames 562-1 and 562-2. In some embodiments, the top and bottom surfaces of the magnetic position sensor may be flush with the top and bottom surfaces of the outer frame 550-2. In some embodiments, the top and bottom surfaces of the magnetic position sensor 554-2 may protrude above or be recessed below the top and / or bottom surfaces of the outer frame 550-2.

[0231] In some embodiments, the grooves 556-1 and 556-2 may be defined by laser cutting. For example, in some embodiments, the lower structure 548 may be defined by laser cutting, including the grooves 556-1 and 556-2. In some embodiments, the lower structure 548 may be produced by molding, including the grooves 556-1 and 556-2. In some embodiments, the lower structure 548 and the grooves 556-1 and 556-2 may be produced by two different processes. For example, the lower structure 548 may be molded, while the grooves 556-1 and 556-2 may be defined by laser. In some embodiments, the grooves 556-1 and 556-2 and the lower structure 548 may each be formed by the same process.

[0232] Figure 12B According to embodiments of this disclosure Figure 12A The image shows a close-up view of the lower structure of the flexible tip of the high-density electrode conduit, further illustrating a magnetic position sensor 554-2 within the outer frame 550-2. In some embodiments, the outer frame 550-2 may define a slot 556-2 defined by slot frames 562-1 and 562-2. As depicted, the magnetic position sensor 554-2 may be disposed between the slot frames 562-1 and 562-2. In some embodiments, a channel may be defined within the outer frame 550-2. For example, as shown... Figure 12B As depicted, a through slot is defined in the outer frame 550-2; however, in some embodiments, a channel may be defined, which may include a recessed area defined in the outer frame 550-2. For example, the outer frame 550-2 may be recessed such that a channel is defined in the surface of the outer frame 550-2, thereby forming a recess for a magnetic position sensor. Therefore, the magnetic position sensor 554-2 may be disposed in the channel such that the magnetic position sensor 554-2 contacts the bottom of the channel, thereby facilitating placement of the magnetic position sensor 554-2.

[0233] Figure 13A This is a top view of a lower structure 570 of the flexible tip of a high-density electrode conduit according to an embodiment of the present disclosure, including magnetic position sensors 576-1, 576-2 located in an outer frame. As depicted, the lower structure 570 may include a first outer frame 572-1 and a second outer frame 572-2. In some embodiments, Figure 13A A portion of the entire underlying structure associated with the flexible tip of the high-density electrode conduit is depicted. For example, Figure 13AThe outer substructure portion of the entire substructure is depicted, which may further include an intermediate frame and / or an inner frame, as discussed further herein. For example, the substructure to which the first outer frame 572-1 and the second outer frame 572-2 belong may have a total of two to eight arms; however, in some embodiments, embodiments of this disclosure may include more than eight arms. As depicted, the first frame 572-1 and the second frame 572-2 may include frame mounting portions 574-1, 574-2.

[0234] In some embodiments, magnetic position sensors 576-1 and 576-2 may be arranged along the first outer frame 572-1 and the second outer frame 572-2, such as... Figure 13A As depicted in the figure. In some embodiments, magnetic position sensors 576-1, 576-2 may be disposed along the top, bottom, interior and / or exterior of each of the first outer frame 572-1 and the second outer frame 572-2. In some embodiments, the first outer frame 572-1 and the second outer frame 572-2 may include mounting features configured to allow the magnetic position sensors 576-1, 576-2 to be mounted along the first outer frame 572-1 and the second outer frame 572-2.

[0235] In some embodiments, as depicted, the first outer frame 572-1 and the second outer frame 572-2 may include cutouts 578-1, 578-2 defined along longitudinally extending portions of the first outer frame 572-1 and the second outer frame 572-2. As depicted, in some embodiments, the cutouts 578-1, 578-2 define mounting spaces that extend longitudinally along the interior of the first outer frame 572-1 and the second outer frame 572-2. As depicted, the cutouts 578-1, 578-2 and associated magnetic position sensors 576-1, 576-2 are shown positioned proximal to the shoulder portions 580-1, 580-2. In some embodiments, the magnetic position sensors 576-1, 576-2 may be positioned along other portions of the first outer frame 572-1 and the second outer frame 572-2. For example, the magnetic position sensors 576-1, 576-2 may be positioned along the outer frames 572-1, 572-2 from... Figure 13A The positions depicted are positioned proximally. In some embodiments, magnetic position sensors 576-1, 576-2 may be located in the distal tip portion 582 of the outer lower structure. Although two magnetic position sensors 576-1, 576-2 are shown arranged along the outer frame 572-1, 572-2, fewer or more magnetic position sensors 576-1, 576-2 may be arranged along the outer frame.

[0236] In some embodiments, as discussed, cutouts 578-1 and 578-2 may be defined in a portion of the first outer frame 572-1 and the second outer frame 572-2. With regard to the second cutout 578-2, the cutout may be defined along the inner edge of the second outer frame 572-2. In some embodiments, although not depicted, cutout 578-2 may be defined along the outer edge of the second outer frame 572-2.

[0237] In some embodiments, the second outer frame 572-2 may be cut to define a notch 578-2. In some embodiments, the portion of the outer frame 572-2 defining the notch 578-2 may be widened such that the lateral width of the cut frame 584 may match the lateral width of the outer frame 572-2 when material is removed from the outer frame 572-2 to define the notch 578-2. As can be seen, this portion of the outer frame 572-2 includes a flare 586 such that the portion of the outer frame 572-2 including the magnetic position sensor 576-2 is wider than the other longitudinal extensions of the outer frame 572-2. In some embodiments, the total lateral width of the cut frame 584 may be less than or greater than the lateral width of the other longitudinal extensions of the outer frame 572-2, for example, the longitudinal extension of the outer frame 572-2 located near the proximal end of the cut frame 584. Therefore, even though the outer frame 572-2 defines a cutout 578-2, the flexibility of the portion of the outer frame 572-2 including the magnetic position sensor can match or nearly match the flexibility of other longitudinal extensions of the outer frame 572-2 (e.g., those longitudinal extensions located near the proximal end of the magnetic position sensor 576-2). Although the above discussion pertains to the second outer frame 572-2, this can also be applied to other frames.

[0238] In some embodiments, the top and bottom surfaces of the magnetic position sensor 576-2 may be flush with the top and bottom surfaces of the outer frame 572-2. In some embodiments, the top and bottom surfaces of the magnetic position sensor 576-2 may protrude above or be recessed below the top and bottom surfaces of the outer frame 572-2.

[0239] In some embodiments, cuts 578-1 and 578-2 may be defined via laser cutting. For example, in some embodiments, the substructure 570 may be defined by laser cutting, including cuts 578-1 and 578-2. In some embodiments, the substructure 570 may be produced via a mold, including cuts 578-1 and 578-2. In some embodiments, the substructure 570 and cuts 578-1 and 578-2 may be produced by two different processes. For example, the substructure 570 may be molded, while cuts 578-1 and 578-2 may be defined by laser. In some embodiments, cuts 578-1 and 578-2 and the substructure 570 may each be defined by the same process.

[0240] 13B is an embodiment according to the present disclosure. Figure 13A A close-up view of a portion of the lower structure of the flexible tip of the high-density electrode conduit depicted further illustrates the magnetic position sensor 576-2 within the outer frame 572-2. In some embodiments, the outer frame 572-2 may define a cutout 578-2, which is defined by a cutout arm 584. As depicted, the magnetic position sensor 576-2 may be disposed within the cutout arm 584. In some embodiments, the magnetic position sensor 576-2 may be disposed outside the cutout arm 584.

[0241] Figure 14 This is a top view of a high-density electrode conduit 600 according to an embodiment of the present disclosure, wherein magnetic position sensors 602-1 and 602-2 are disposed in the outer arms 604-1 and 604-5 of the high-density electrode conduit 600. As depicted, the high-density electrode conduit 600 may include a proximal coupling member 606, to which longitudinally extending arms 604-1, 604-2, ..., 604-5 are coupled as discussed herein. In some embodiments, one or more electrodes 608 may be disposed along one or more of the arms. In some embodiments, the high-density electrode conduit 600 may include more or fewer than five arms 604-1, 604-2, ..., 604-5.

[0242] In some embodiments, the high-density electrode conduit 600 may include magnetic position sensors disposed along one or more of the longitudinally extending arms 604-1, 604-2, ..., 604-5. As depicted, a first magnetic position sensor 602-1 and a second magnetic position sensor 602-2 may be disposed along a portion of the first outer arm 604-1 and the second outer arm 604-5. In some embodiments, the frame associated with the first outer arm 604-1 and the second outer arm 604-5 may include a frame related to... Figures 12A to 13B The features discussed are the same or similar.

[0243] As depicted, the frame associated with the first arm 604-1 and the second arm 604-5 may include cutouts in which magnetic position sensors 602-1 and 602-2 may be respectively disposed. In some embodiments, the frame associated with the first arm 604-1 and the second arm 604-5 may include slots, such as... Figure 12A and Figure 12B The discussion is as follows. Although the first arm 604-1 and the second arm 604-2 are generally discussed herein, in some embodiments, magnetic position sensors may be disposed on other arms 604-2, 604-3, 604-4 of the arm. Although magnetic position sensors 602-1, 602-2 are shown as disposed on the distal portions of the longitudinal extensions of the first arm 604-1 and the second arm 604-2, magnetic position sensors 602-1, 602-2 may be disposed distally and / or proximally from the currently shown position.

[0244] In some embodiments, the frame associated with arms 604-1, 604-2, ..., 604-5 may include materials such as nitinol, stainless steel, and titanium. In some embodiments, conduits may be provided above magnetic position sensors 602-1 and 602-2 to help retain the magnetic position sensors and prevent them from separating. In some embodiments, conduits may be provided above magnetic position sensors 602-1 and 602-2, with the magnetic position sensors 602-1 and 602-2 disposed within an external conduit, and an electrode 608 disposed on the external conduit. In some embodiments, the external conduit may be used to retain magnetic position sensors 602-1 and 602-2 without using internal conduits.

[0245] This document describes embodiments of various devices, systems, and / or methods. Numerous specific details are set forth to provide a thorough understanding of the overall structure, function, manufacture, and use of the embodiments described in the specification and illustrated in the accompanying drawings. However, those skilled in the art will understand that embodiments may be practiced without such specific details. In other instances, well-known operations, components, and elements have not been described in detail so as not to obscure the embodiments described in the specification. Those skilled in the art will understand that the embodiments described and illustrated herein are non-limiting examples, and therefore it can be understood that the specific structural and functional details disclosed herein may be representative and do not necessarily limit the scope of the embodiments, which are defined only by the appended claims.

[0246] Throughout this specification, references to "various embodiments," "some embodiments," "one embodiment," or "embodiment" or similar expressions mean that at least one embodiment includes a particular feature, structure, or characteristic described in connection with the embodiments(s). Therefore, the phrases "in various embodiments," "in some embodiments," "in one embodiment," or "in an embodiment," or similar expressions appearing throughout this specification do not necessarily refer to the same embodiment. Furthermore, a particular feature, structure, or characteristic can be combined in any suitable manner in one or more embodiments. Thus, a particular feature, structure, or characteristic illustrated or described in connection with one embodiment can be combined, in whole or in part, with features, structures, or characteristics of one or more other embodiments without limitation, provided that such combination is not illogical or ineffective.

[0247] It will be understood that the terms "proximal" and "distal" may be used throughout the manual to refer to the end of the instrument used to treat a patient by a clinician. The term "proximal" refers to the portion of the instrument closest to the clinician, and the term "distal" refers to the portion furthest from the clinician's positioning. It will also be understood that, for the sake of brevity and clarity, spatial terms such as "vertical," "horizontal," "upper," and "lower" may be used relative to the illustrated embodiments herein. However, surgical instruments can be used in many orientations and positions, and these terms are not intended to be limiting or absolute.

[0248] Although at least one embodiment for a high-density electrode conduit has been described above with a degree of specificity, various modifications can be made to the disclosed embodiments by those skilled in the art without departing from the spirit or scope of this disclosure. All directional references (e.g., upper, lower, upward, downward, left, right, left-to-right, top, bottom, above, below, vertical, horizontal, clockwise, and counterclockwise) are used for identification purposes only to aid the reader's understanding of this disclosure and do not impose limitations, particularly regarding the location, orientation, or use of the device. Engagement references (e.g., attachment, connection, coupling, linking, etc.) should be interpreted broadly and can include intermediate members and relative movement between elements during connection. Thus, engagement references do not necessarily imply that two elements are directly connected and in a fixed relationship with each other. All items contained in the above description or shown in the drawings should be interpreted as illustrative rather than restrictive. Changes in detail or structure may be made without departing from the spirit of this disclosure as defined in the appended claims.

[0249] Any patent, publication, or other disclosure incorporated herein by reference (in whole or in part) shall be incorporated herein only to the extent that the incorporated material does not conflict with the existing definitions, statements, or other disclosures set forth herein. Thus, and to the extent necessary, any conflicting material incorporated herein by reference shall supersede any material incorporated herein by reference that conflicts with existing definitions, statements, or other disclosures set forth herein. Any material incorporated herein by reference that conflicts with existing definitions, statements, or other disclosures set forth herein, or any part thereof, shall be incorporated herein only to the extent that the incorporated material does not conflict with the existing disclosures.

Claims

1. A catheter comprising: a catheter shaft comprising a proximal end and a distal end, the catheter shaft defining a catheter shaft longitudinal axis; a flexible frame coupled to the distal end of the catheter shaft, wherein the flexible frame comprises: a first longitudinally extending lateral arm and a second longitudinally extending lateral arm; a first longitudinally extending medial arm and a second longitudinally extending medial arm; and a first longitudinally extending medial arm and a second longitudinally extending medial arm; and a first longitudinally extending medial arm and a second longitudinally extending medial arm; and a proximal coupler from which the first and second lateral arms, the first and second medial arms, and the first and second medial arms extend, wherein the first and second lateral arms and the first and second medial arms depart the proximal coupler in a common plane, and the first and second medial arms depart the proximal coupler below or above the common plane and extend distally away from the proximal coupler; a plurality of electrodes disposed on each of the first lateral arm, the second lateral arm, the first medial arm, the second medial arm, the first medial arm, and the second medial arm; and 2. The catheter of claim 1, wherein, a distal coupler that couples the first lateral arm, the second lateral arm, the first medial arm, the second medial arm, and a distal portion of the distal tubular portion.

3. The catheter of claim 2, wherein, the first and second medial arms extend distally away from the proximal coupler and toward the common plane.

4. The catheter of claim 3, wherein, the first medial arm departs the proximal coupler below the common plane and extends distally away from the proximal coupler.

5. The catheter of claim 1, wherein, the second medial arm departs the proximal coupler above the common plane and extends distally away from the proximal coupler.

6. The catheter of claim 5, wherein, the distal tubular portion is devoid of electrodes disposed thereon. the distal tubular portion flares laterally relative to the catheter shaft longitudinal axis.

8. The catheter of claim 7, further comprising a connecting stem portion connected to the proximal coupling, wherein, 7. The catheter of claim 1, further comprising a first magnetic position sensor and a second magnetic position sensor disposed at a distal end of the catheter shaft. the link portion defines a first sensor groove configured to receive the first magnetic position sensor and a second sensor groove configured to receive the second magnetic position sensor.

9. The catheter of claim 1, further comprising a first magnetic position sensor disposed on the first lateral arm and a second magnetic position sensor disposed on the second lateral arm.

11. The catheter of claim 1, wherein, 10. The catheter of claim 1, further comprising a tip magnetic position sensor disposed at a distal portion of the flexible frame.

12. The catheter of claim 1, wherein, the proximal coupler comprises at least one irrigation port.

13. The catheter of claim 1, wherein, the distal coupler comprises at least three mounting lumens configured to receive distal portions of the first and second lateral arms, the first and second medial arms, and the distal tubular portion.

14. The catheter of claim 13, wherein, the plurality of electrodes are configured to deliver energy to ablate cardiac tissue of a patient using pulsed field ablation. the pulsed field ablation comprises short duration direct current pulses of 0.1 milliseconds to 20 milliseconds, and an electric field strength of 0.1 kilovolts per centimeter to 1.0 kilovolts per centimeter.

15. The catheter of claim 1, wherein, The plurality of electrodes are configured to sense electrical signals generated by cardiac tissue of a patient.

16. The catheter of claim 1, further comprising a flexible circuit disposed on one or more portions of the first lateral arm, the second lateral arm, the first medial arm, the second medial arm, the first medial arm, and the second medial arm.

17. The catheter of claim 16, wherein, One or more of the plurality of electrodes are disposed on or formed on the flexible circuit, the flexible circuit disposed on one or more portions of the first lateral arm, the second lateral arm, the first medial arm, the second medial arm, the first medial arm, and the second medial arm.

18. The catheter of claim 1, wherein, One or more of the plurality of electrodes comprise ring electrodes.

19. The catheter of claim 1, wherein, The proximal ends of the first lateral arm, the second lateral arm, the first medial arm, the second medial arm, the first medial arm, and the second medial arm each comprise a mounting portion.

20. The catheter of claim 19, wherein, The mounting portion comprises a clip secured to the proximal end coupling.

21. A catheter, comprising: a catheter shaft comprising a proximal end and a distal end, the catheter shaft defining a catheter shaft longitudinal axis; a flexible frame connected to the distal end of the catheter shaft, wherein the flexible frame comprises: a longitudinally extending first lateral arm and a longitudinally extending second lateral arm; a longitudinally extending first medial arm and a longitudinally extending second medial arm; and a longitudinally extending first medial arm and a longitudinally extending second medial arm, wherein distal portions of the first and second medial arms have a curvature along a longitudinal length; a proximal coupling from which the first and second lateral arms, the first and second medial arms, and the first and second medial arms extend, wherein the first and second lateral arms and the first and second medial arms depart the proximal coupling in a common plane, and the first and second medial arms depart the proximal coupling below or above the common plane and extend distally away from the proximal coupling; a plurality of electrodes disposed on each of the first lateral arm, the second lateral arm, the first medial arm, the second medial arm, the first medial arm, and the second medial arm; and a distal coupling connecting distal portions of the first and second lateral arms, the first and second medial arms, and the first and second medial arms.

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