High density electrode catheter with magnetic position tracking

Abstract

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

Description

[0001] CLAIM OF PRIORITY

[0002] This application claims priority to U.S. Provisional Patent Application No. 63 / 067,284, filed August 18, 2020, which is incorporated by reference herein as if fully set forth in its entirety in this document. TECHNICAL FIELD

[0003] The present disclosure relates to high-density electrode catheters with magnetic position tracking. BACKGROUND

[0004] Catheters have been used for cardiac medical procedures for many years. For example, catheters can be positioned at particular locations within the body to diagnose and treat cardiac arrhythmias that are otherwise inaccessible without more invasive procedures.

[0005] Traditional mapping catheters can include, for example, a plurality of proximate ring electrodes encircling a longitudinal axis of the catheter, which can be constructed of platinum or some other metal. These ring electrodes are relatively rigid. Similarly, traditional ablation catheters can include a relatively rigid tip electrode for delivering therapy (e.g., delivering RF ablation energy), and can also include a plurality of proximate ring electrodes. When using these traditional catheters and their relatively rigid (or non-compliant) metal electrodes, it can be difficult to maintain good electrical contact with cardiac tissue, particularly when there are sharp gradients and undulations.

[0006] Whether mapping or creating lesions in the heart, the beating of the heart, particularly an unstable or irregular beat, complicates matters such that it is difficult to maintain sufficient contact between the electrode and the tissue for a sufficient amount of time. These problems are exacerbated on contoured or trabeculated surfaces. If the contact between the electrode and the tissue cannot be sufficiently maintained, it is not possible to create high quality lesions or accurate maps.

[0007] The above discussion is merely provided for illustration and should not be considered to limit the scope of the claims in any way. SUMMARY

[0008] Various embodiments of the present disclosure can include a high-density electrode catheter. In some embodiments, the high-density electrode catheter can include a catheter shaft including a proximal end and a distal end, the catheter shaft defining a catheter shaft longitudinal axis. In some embodiments, the high-density electrode catheter can include a shaft magnetic position sensor disposed along a distal portion of the catheter shaft. In some embodiments, the high-density electrode catheter can include a flexible tip portion positioned proximate the distal end of the catheter shaft, wherein the flexible tip portion includes a flexible frame. In some embodiments, the high-density electrode catheter can include a plurality of electrodes disposed on the flexible frame. In some embodiments, the high-density electrode catheter can include a tip magnetic position sensor disposed on a portion of the flexible frame.

[0009] Various embodiments of the present disclosure can include a high-density electrode catheter. In some embodiments, the high-density electrode catheter can include a catheter shaft including a proximal end and a distal end, the catheter shaft defining a catheter shaft longitudinal axis. In some embodiments, the high-density electrode catheter can include a flexible tip portion positioned proximate the distal end of the catheter shaft, wherein the flexible tip portion includes a flexible frame including a first lateral arm, a second lateral arm, and a central arm extending longitudinally. In some embodiments, the high-density electrode catheter can 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 can include a tip magnetic position sensor disposed on a distal portion of the central arm.

[0010] Various embodiments of the present disclosure can include a high-density electrode catheter. In some embodiments, the high-density electrode catheter can include a catheter shaft including a proximal end and a distal end, the catheter shaft defining a catheter shaft longitudinal axis. In some embodiments, the high-density electrode catheter can include a flexible tip portion positioned proximate the distal end of the catheter shaft, wherein the flexible tip portion includes a flexible frame. In some embodiments, the high-density electrode catheter can include a flexible circuit disposed on the flexible frame, wherein the flexible circuit includes a plurality of electrodes disposed thereon. In some embodiments, the high-density electrode catheter can include a tip magnetic position sensor disposed on a portion of the flexible frame. BRIEF DESCRIPTION OF DRAWINGS

[0011] FIG. 1A is a schematic diagram of a catheter system in accordance with embodiments of the present disclosure.

[0012] FIG. 1B is a schematic block diagram of an electroporation therapy system in accordance with embodiments of the present disclosure.

[0013] FIG. 2A is a top view of a high-density electrode catheter in accordance with various embodiments of the present disclosure, and FIG. 2B is an isometric side and top view of a high-density electrode catheter in accordance with various embodiments of the present disclosure.

[0014] FIG. 3A These are isometric side and top views of high-density electrode conduits according to various embodiments of the present disclosure, and FIG. 3B This is a bottom view of a high-density electrode conduit according to various embodiments of the present disclosure.

[0015] FIG. 3C According to embodiments of this disclosure FIG. 3A and FIG. 3B The side view of the high-density electrode conduit depicted in the image.

[0016] FIG. 3D According to embodiments of this disclosure FIGS. 3A-3C Isometric side and bottom views of the high-density electrode conduit depicted in the figure.

[0017] FIG. 3E According to embodiments of this disclosure FIGS. 3A-3D The image depicts isometric top and side views of a high-density electrode conduit, with further depiction of the manifold portion.

[0018] FIG. 3F According to embodiments of this disclosure FIGS. 3A-3E Isometric bottom and side views of the high-density electrode conduit depicted in the figure, further depicting... FIG. 3E The manifold section.

[0019] FIG. 3G According to embodiments of this disclosure FIGS. 3A-3F The image depicts isometric top and side views of a high-density electrode conduit, with further details of the mounting portion.

[0020] FIG. 3H According to embodiments of this disclosure FIGS. 3A-3G Isometric bottom and side views of the high-density electrode conduit depicted in the figure, further depicting... FIG. 3G The installation part.

[0021] FIG. 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.

[0022] FIG. 3J According to embodiments of this disclosure FIGS. 3A-3I Isometric bottom and side views of the flexible underlying structure of the high-density electrode conduit depicted in the figure.

[0023] FIG. 3K This is a cross-sectional view of a dual-lumen tube according to an embodiment of the present disclosure.

[0024] FIG. 3L According to embodiments of this disclosureFIG. 3H Isometric bottom and side view of high density electrode catheter depicted in

[0025] FIG. 3M Isometric bottom view of proximal end of flexible substructure according to embodiments of the present disclosure FIG. 3G and FIG. 3H Isometric proximal view of mounting portion depicted in

[0026] FIG. 3N Isometric bottom and side view of proximal end of flexible substructure according to embodiments of the present disclosure

[0027] FIG. 3O Bottom view of proximal end of flexible substructure according to embodiments of the present disclosure

[0028] FIG. 3P Bottom view of proximal end of flexible substructure disposed in mounting portion depicted in cross-sectional view according to embodiments of the present disclosure

[0029] FIG. 3Q Isometric distal view of connecting rod portion according to embodiments of the present disclosure

[0030] FIG. 3R Isometric bottom view of connecting rod portion depicted in FIG. 3G Isometric proximal view of connecting rod portion depicted in

[0031] FIG. 3S Isometric bottom view of connecting rod portion depicted in FIG. 3J Bottom view of distal portion of flexible substructure with added electrodes, distal outer substructure conduit, and atraumatic tip depicted in

[0032] FIG. 3T Isometric bottom view of distal portion of flexible substructure according to embodiments of the present disclosure FIG. 3J Bottom view isometric view of distal portion of flexible substructure with added electrodes, distal inner substructure conduit, and atraumatic tip depicted in

[0033] FIG. 3U Isometric bottom view of distal portion of flexible substructure according to embodiments of the present disclosure FIG. 3J Bottom view isometric view of distal portion of flexible substructure with no distal coupling and magnetic position sensor mount depicted in

[0034] FIG. 4 Top view of high density electrode catheter with flexible tip portion having a pair of magnetic position sensors disposed on a distal portion of the flexible tip portion according to embodiments of the present disclosure

[0035] FIG. 5A Isometric view of high density electrode catheter including six longitudinally extending arms according to embodiments of the present disclosure

[0036] FIG. 5B is a high-density electrode catheter including six longitudinally extending arms according to embodiments of the present disclosure FIG. 5A is a distal-facing isometric view of the high-density electrode catheter depicted in

[0037] FIG. 5C is a high-density electrode catheter according to embodiments of the present disclosure FIG. 5A is a high-density electrode catheter according to embodiments of the present disclosure

[0038] FIG. 5D is a high-density electrode catheter according to embodiments of the present disclosure FIG. 5A is a side view of the high-density electrode catheter of

[0039] FIG. 6A is an isometric view of the underlying structure of the flexible tip of the high-density electrode catheter according to embodiments of the present disclosure

[0040] FIG. 6B is a proximal view of the mounting portion depicted in FIG. 6A

[0041] is a distal flexible tip portion of a high-density electrode catheter having a particular electrode configuration according to embodiments of the present disclosure FIG. 7

[0042] depicts various electrode spacing configurations of electrodes disposed on a distal flexible tip portion of a high-density electrode catheter according to embodiments of the present disclosure FIGS. 8A-8E

[0043] is an isometric rear view of a distal tip assembly including a magnetic position sensor mount and a distal coupling according to embodiments of the present disclosure FIG. 9

[0044] is a side view of a distal tip assembly including a magnetic position sensor mount and a distal coupling according to embodiments of the present disclosure FIG. 10

[0045] is a top view of a high-density electrode catheter having staggered electrodes according to embodiments of the present disclosure FIG. 11

[0046] is a top view of the underlying structure of the flexible tip of the high-density electrode catheter including a magnetic position sensor located in an outer frame according to embodiments of the present disclosure FIG. 12A

[0047] is a high-density electrode catheter according to embodiments of the present disclosure FIG. 12B FIG. 12A ​Close-up view of the lower structure of the flexible tip of a high-density electrode catheter as depicted in FIG. 1 1, with further depiction of the magnetic position sensor in the outer frame.

[0048] FIG. 13A Top view of the lower structure of the flexible tip of a high-density electrode catheter including a magnetic position sensor located in the outer frame, according to embodiments of the present disclosure.

[0049] FIG. 13B Top view of the lower structure of the flexible tip of a high-density electrode catheter including a magnetic position sensor located in the outer frame, according to embodiments of the present disclosure. FIG. 13A Close-up view of the lower structure of the flexible tip of a high-density electrode catheter as depicted in FIG. 1 1, with further depiction of the magnetic position sensor in the outer frame.

[0050] FIG. 14 Top view of a high-density electrode catheter with a magnetic position sensor disposed in the outer arm of the high-density electrode catheter, according to embodiments of the present disclosure. DETAILED DESCRIPTION

[0051] Reference is now made to the drawings, wherein like reference numerals are used to identify like parts throughout the various figures, FIG. 1A is a schematic diagram of a catheter system with which the present application can be practiced. The system can include various visualization, mapping, and navigation components as known in the art, including, for example, the EnSite® TM Precision TM cardiac mapping and visualization system, as discussed further herein.

[0052] The system can be used in conjunction with or for various medical procedures, for example, cardiac mapping and / or cardiac ablation procedures. In one embodiment, the medical positioning system 14 can include a magnetic field-based system, for example, the CARTO® system, available from Biosense Webster, and as generally shown in one or more of U.S. Patent Nos. 6,498,944, 6,788,967, and 6,690,963, the entire disclosures of which are incorporated herein in their entirety as if fully set forth herein. In another embodiment, the magnetic field-based system can include, in part, a magnetic field-based system, for example, the MediGuide® TMtechnological systems, and as generally shown in one or more of U.S. Patent Nos. 6,233,476; 7,197,354; and 7,386,339; U.S. Patent Application No. 14 / 208,120, filed March 13, 2014, entitled "Medical Device Navigation System," U.S. Provisional Patent Application No. 61 / 834,223, filed June 12, 2013, entitled "Medical Device Navigation System," and International Application No. PCT / IB2014 / 059709, filed March 13, 2014, entitled "Medical Device Navigation System," the disclosures of which are hereby incorporated by reference in their entireties, as if fully set forth herein.

[0053] In yet another embodiment, medical positioning system 14 can include a combination of a magnetic field-based system and an electric field-based system, such as, but not limited to, the systems described in pending 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 hereby incorporated by reference in its entirety, as if fully set forth herein, or include systems commercially available from 3systems. In some embodiments, medical positioning system 14 can include or be used in conjunction with other commonly used systems, such as, but not limited to, fluoroscopy, computed tomography (CT), and magnetic resonance imaging (MRI) based systems. For purposes of clarity and illustration only, medical positioning system 14 is described below as including a hybrid magnetic and impedance tracking system. Although reference is made to cardiac mapping of the heart, one or more aspects of the present disclosure can be applied to other anatomical structures.

[0054] Reference is made to FIG. 1AThe 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, FIG. 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, both commercially available from Abbott Laboratories or as commonly seen with reference to U.S. Patent No. 7,263,397 ('397 patent) or U.S. Patent No. 2007 / 0060833A1, U.S. Application No. 11 / 227,580 ('580 application), filed September 15, 2005, or U.S. Application No. 2018 / 0296111A1, U.S. Application No. 15 / 953,155 ('155 application), filed April 13, 2018. TM NavX TM Electroanatomical mapping system, EnSite TM Velocity TM Electroanatomical mapping system and EnSite Precision TM Electroanatomical mapping system. '397 patent, '580 application and '155 application are incorporated herein by reference as if fully set forth herein.

[0055] Various EnSite TM The system is 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 the 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 The system can be used to practice this invention, including, for example, those from Bernsons Webster Corporation. Navigation and positioning systems or Northern Digital Inc. Both systems 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, for example in the case of an impedance-based positioning system, may include one or more electrodes configured to detect one or more characteristics of an electric field, or alternatively, for example in the case of a magnetic field-based positioning system, may include one or more coils (e.g., wire windings) configured to detect one or more characteristics of a magnetic field.

[0056] It should further be appreciated that in some positioning systems, one or more position sensors can collectively define a sensor. The one or more position sensors can be disposed on a distal end of a catheter, and the positioning system can be configured to obtain position information from the one or more position sensors. The positioning system can not only use the received position information, but also use the geometric relationship between the one or more position sensors providing the position information and the distal end position on the catheter (e.g., one piece of geometric information can be the distance from the ring electrode to the tip) to calculate the distal end position of the catheter. Finally, the positioning system can use the calculated position as if that position was collected directly. Likewise, 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 position was collected directly. Of course, other variations are possible.

[0057] With continued reference to FIG. 1A In the illustrated impedance-based positioning system embodiment, three sets of surface electrodes are shown (e.g., applied via patches): X-axis electrodes 12, 14; Y-axis electrodes 18, 19; and Z-axis electrodes 16, 22. In some embodiments, an additional surface electrode 21 can be used (e.g., applied via an "abdominal" patch). The surface electrodes are all connected to a switch 24. A representative catheter 13 is shown having a single distal electrode 17, which can be referred to herein as a "roving" or "measurement" electrode. In some embodiments, the catheter 13 can be a coronary sinus catheter or a right ventricular apex catheter. In this embodiment, the electrode 17 can define a position sensor, although as noted above, many variations are possible, and the catheter 13 can include multiple position sensors, as discussed further herein. FIG. 1A A second, independent catheter 29 is also shown having a fixed reference electrode 31 that can be fixed to the heart 10 for calibration purposes.

[0058] FIG. 1AA computer system 20, signal generator 25, analog-to-digital converter 26, and low pass filter 27 are further shown. 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. The hardware, for example, can include a processing resource 32 and / or a memory resource 33 (e.g., a non-transitory computer readable medium (CRM) database, etc.). The processing resource 32, as used herein, can include multiple processors capable of executing instructions stored by the memory resource 33. The processing resource 32 can be integrated in a single device or distributed across multiple devices. The instructions (e.g., computer readable instructions (CRI)) can include instructions stored on the memory resource 33 and executable by the processing resource 32 to align a cardiac model.

[0059] The computer system 20 is configured to control the signal generator 25 according to a predetermined strategy to selectively energize various pairs of surface electrodes. In operation, the computer system 20 is configured to obtain raw patch data (i.e., voltage readings) via the filter 27 and A-D converter 26 and use the raw patch data to determine raw electrode position coordinates in three-dimensional space (X, Y, Z) of a catheter electrode (e.g., the aforementioned roving electrode 17) positioned inside the heart 10 or a chamber thereof. In some embodiments, when such electrode position coordinates are received, a phase of a cardiac cycle of the 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 the patient 11, which are coupled to body surface electrodes and collectively identified by reference numeral 15.

[0060] Alternatively, a reference electrode (e.g., fixed reference electrode 31) positioned at a fixed location in the heart 10 can be used to provide a relatively stable signal that can be analyzed to determine a cardiac phase of the heart 10 during a cardiac cycle (e.g., placed at the coronary sinus). More generally, another catheter (non- moving or roving catheter) with an electrode can be placed relative to the heart 10 and held in a constant position to obtain a relatively stable signal indicative of a cardiac phase. As shown, the ECG leads 15 are coupled directly to the computer system 20 for acquisition and subsequent processing to obtain a phase of the heart 10 during a cardiac cycle. The ECG leads 15 can also be provided to other systems (not shown).

[0061] As previously mentioned, embodiments of the present disclosure can be used with a magnetic field-based system. Some embodiments can 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 an MPS-enabled medical device (e.g., an elongated catheter or introducer) that itself includes one or more of the MPS position sensors described above.

[0062] As discussed, in some embodiments, the medical positioning system can include a magnetic field-based system, such as, for example, the MediGuide® TM Technologies system, and as generally shown in one or more of U.S. Patent Nos. 6,233,476; 7,197,354; and 7,386,339; U.S. Patent Application No. 14 / 208,120, filed March 13, 2014, entitled "Medical Device Navigation System," U.S. Provisional Patent Application No. 61 / 834,223, filed June 12, 2013, entitled "Medical Device Navigation System," and International Application No. PCT / IB2014 / 059709, filed March 13, 2014, entitled "Medical Device Navigation System," the disclosures of which are hereby incorporated by reference in their entireties, as if set forth fully herein.

[0063] Embodiments can include input / output mechanisms, which can include conventional devices, such as a keyboard, mouse, input pad, foot pedal, switches, etc., for interfacing with the computer-based control unit. Embodiments can also include a display 23, which can also include conventional devices.

[0064] Embodiments can be used in navigation applications that utilize imaging of regions of interest. Thus, the magnetic field-based system can optionally include an image database. The image database can be configured to store image information related to the patient's body, e.g., a region of interest around a target site of a medical device and / or a plurality of regions of interest along a navigation path through which the device is intended to travel to reach the target site. The image data in the image database can include known image types including: (1) one or more two-dimensional static images acquired at various separate times in the past; (2) a plurality of related two-dimensional images obtained in real-time from an image acquisition device (e.g., fluoroscopic images from an x-ray imaging apparatus), where the image database acts as a buffer (real-time fluoroscopy); and / or (3) a sequence of related two-dimensional images defining a cine loop (CL), where each image in the sequence has at least an ECG timing parameter associated therewith sufficient to allow the sequence to be played back in accordance with a real-time ECG signal obtained from an ECG monitor. It should be appreciated that the foregoing are merely examples in nature and not limiting. For example, the image database can also include three-dimensional image data. It should be further appreciated that the images can be acquired by any imaging modality now known or later developed (e.g., x-ray, ultrasound, computed tomography, nuclear magnetic resonance, etc.).

[0065] The MPS can be configured to function as a positioning system, to determine positioning (position 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 (PRSs), and to output corresponding position readings. The position readings can each include at least one or both of a position and an orientation (P&O) relative to a reference coordinate system (which can be a coordinate system of the MPS). For example, the P&O can be expressed as a position (i.e., coordinates in three axes X, Y, and Z) and an orientation (i.e., azimuth and elevation) of a magnetic field sensor in a magnetic field relative to a magnetic field generator or transmitter.

[0066] The MPS determines the respective positions (i.e., P&O) in the reference coordinate system based on captured and processed signals received from the magnetic field sensors, which are disposed in a controlled low-intensity AC magnetic field. From an electromagnetic standpoint, these sensors produce voltages induced on coils in a varying magnetic field, as contemplated herein. Thus, the sensors are configured to detect one or more characteristics of the magnetic field in which they are disposed, and to produce an indicative signal, which is further processed by the MPS to obtain the respective P&O of the sensors. Exemplary design features and manufacturing processes and methods for the sensors and medical devices containing such sensors can be found in U.S. Patent No. 8,636,718, which is incorporated by reference herein in its entirety.

[0067] The MPS sensors, and in further embodiments optionally additional MPS sensors, can be associated with the MPS-enabled medical device. Another MPS sensor, i.e. a patient reference sensor (PRS), is configured to provide a position reference of the patient's body in order to allow for motion compensation of the overall motion of the patient's body and / or the motion caused by respiration. The PRS can be attached to the patient's sternum, to a stable position on the chest or to another position on the body that is relatively stable. Like the MPS position sensors, the PRS is configured to detect one or more properties of the magnetic field it is in, wherein the MPS provides a position reading (e.g. P&O reading) indicative of the position and orientation of the PRS in the reference coordinate system.

[0068] An electrocardiogram (ECG) monitor is configured to continuously detect electrical timing signals of the heart organ by using a plurality of ECG electrodes (not shown) that can be externally fixed to the outside of the patient's body. The timing signals typically correspond to specific phases of the cardiac cycle. Typically, the ECG signals can be used by the control unit for ECG-synchronized playback (video playback) of previously captured image sequences stored in a database. Both the ECG monitor and the ECG electrodes can comprise conventional components.

[0069] The magnetic field-based system can be incorporated into or associated with a fluoroscopic imaging system, which can comprise commercially available fluoroscopic imaging components, e.g. an x-ray source, a C-arm and / or an x-ray image intensifier or detector (i.e. "catheter lab"). The MPS (electromagnetic sensor tracking system) comprises a magnetic transmitter 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 the patient's thorax and around it in a predefined three-dimensional space identified as a motion box.

[0070] As described above, the MPS sensors are configured to sense one or more properties of the magnetic field when the sensors are in the motion box and each generate a respective signal that is provided to the magnetic processing core. The processing core responds to these detected signals and is configured to calculate a respective P&O reading for each MPS sensor in the motion box. The processing core can detect when an MPS sensor leaves the motion box. Thus, the MPS enables real-time tracking of each sensor in the three-dimensional space.

[0071] The actual volume of the motion box can be stored, for example, in the processing core, and the processing core can determine 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 the master control, and the master control can determine the position and orientation of each sensor relative to the boundaries of the motion box. Thus, the system can evaluate (e.g., in the processing core or in the master control) whether a sensor is within the motion box, at the boundaries of the motion box, or outside of the motion box. Based on this information, the motion box and the sensors can be displayed relative to each other on a display, as described in greater detail elsewhere herein.

[0072] In some alternative embodiments, the MTA can be located below the patient table, between the x-ray source and the patient table. For example, the MTA can be coupled with the patient table. In some embodiments, the MTA can be a mobile device that can be placed on the patient's chest and used to generate a magnetic field for tracking objects, as discussed herein.

[0073] The positional relationship between the image coordinate system and the MPS reference coordinate system (electromagnetic tracking coordinate system) can be calculated based on a known optical-magnetic calibration of the system (e.g., established during setup), as the positioning system and the imaging system can be considered fixed relative to each other in such embodiments. However, for other embodiments using other imaging modalities, including embodiments where image data is acquired at an earlier time and then imported from an external source (e.g., imaging data stored in a database), a registration step can be required to register the MPS coordinate system and the image coordinate system so that MPS position readings can be properly coordinated with any particular image used.

[0074] As previously mentioned, embodiments of the present disclosure can be used in conjunction with or for various medical procedures, for example, mapping of the heart and / or cardiac ablation therapy procedures. In some embodiments, ablation therapy can be used to treat various conditions that afflict human anatomy. One such condition for which ablation therapy can be used is the treatment of cardiac arrhythmias. When tissue is ablated or at least subjected to ablation energy generated by an ablation generator and delivered by an ablation catheter, a lesion is formed in the tissue. An electrode mounted on or in the ablation catheter is used to create tissue necrosis in cardiac tissue to correct conditions such as atrial arrhythmias, including but not limited to, ectopic atrial tachycardia, atrial fibrillation, and atrial flutter. Cardiac arrhythmias can lead to various dangerous conditions, including atrioventricular asynchrony and stasis of blood flow. It is believed that the primary cause of atrial arrhythmias is a stray electrical signal 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 a lesion in the cardiac tissue. This lesion disrupts the undesired electrical pathway, thereby limiting or preventing the stray electrical signal that causes the arrhythmia.

[0075] In some embodiments, ablation can include electroporation. Electroporation is a non-thermal ablation technique that involves the application of a strong electric field that induces pore formation in cell membranes. The electric field can be induced by the application of a relatively short duration pulse, which can last, for example, from one nanosecond to several milliseconds. Such a pulse can be repeated to form a pulse train. When such an electric field is applied to tissue in a living environment, cells in the tissue are subjected to a transmembrane potential, 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, appropriately configured pulse trains can be used alone to induce cell destruction, for example, by causing irreversible electroporation.

[0076] FIG. 1B is a schematic block diagram of an electroporation therapy system 40 in accordance with embodiments of the present disclosure. Generally, various embodiments include an electrode assembly 42 disposed at a distal end of a catheter 44. The electrode assembly 42 includes one or more individually 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.

[0077] The system 40 can be used to perform irreversible electroporation to destroy tissue. In particular, the 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), resulting in its rupture and cell necrosis. This mechanism of cell death can be viewed as an “outside-in” process, meaning that the destruction of the cell’s outer wall has a deleterious effect on the cell’s 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 a direct current (DC) pulse of short duration (e.g., 0.1 to 20 ms duration) between closely spaced electrodes capable of delivering electric field strengths of approximately 0.1 to 1.0 kV / cm.

[0078] The system 40 includes a catheter electrode assembly 42 that includes at least one catheter electrode configured for use as outlined above and described in greater detail below. The electrode assembly 42 is incorporated as part of a medical device (e.g., a catheter 44 for performing electroporation therapy on tissue 46 in a patient’s body 48). In illustrative embodiments, the tissue 46 includes a heart or heart tissue. However, it should be understood that embodiments can be used to perform electroporation therapy with respect to various other body tissues.

[0079] FIG. 1AA plurality of return electrodes, identified as 50, 52, and 54, are further shown, which are a schematic representation of body connections that can be used by various subsystems included in the overall system 40 (e.g., an electroporation generator 56, an electrophysiology (EP) monitor (e.g., an ECG monitor 60), a positioning and navigation system 62 for visualization, mapping, and navigation of internal body structures). In the illustrated embodiment, the 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 the sake of clarity) and that such subsystems to which these patch electrodes are connected can include and typically will include more than one patch (body surface) electrode.

[0080] In some embodiments, the 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. A return electrode that is a catheter electrode can be part of the electrode assembly 42 or part of a separate catheter (not shown). The system 40 can also include a host computer system 64 (including an electronic control unit 78 and data storage - memory 80), which in certain embodiments can be integrated with the system 62. In some embodiments, the host computer system 64 can be integrated with the computer system 20 depicted in FIG. 1. The system 64 can also include conventional interface components, such as various user input / output mechanisms 66A and a display 66B, among other components. The variable impedance device 58 causes the impedance of the system to vary to limit arcing from the catheter electrodes of the catheter 44. In some embodiments, the variable impedance device 58 is variable in response to appropriate control signals from the computer system 64. FIG. 1A

[0081] In the illustrative embodiment, the catheter 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. The catheter 44 can also include other conventional components not illustrated herein, such as temperature sensors, additional electrodes, and corresponding conductors or leads. The connector 68 provides mechanical and electrical connections for a cable 82 that extends from the generator 56. The connector 68 can include conventional components known in the art and is disposed at the proximal end of the catheter 44 as shown.

[0082] FIG. 2A is a top view of a high-density electrode catheter 101 in accordance with various embodiments of the present disclosure, FIG. 2B ​is an isometric side view and a top view of a high-density electrode catheter 101. In some embodiments, the high-density electrode catheter 101 can include a flexible tip portion 110 that forms a flexible array of electrodes 102. This planar array (or "paddle" configuration) of electrodes 102 includes four longitudinally extending arms 103, 104, 105, 106 arranged side-by-side, which can form a flexible frame on which the electrodes 102 are disposed. The four electrode-carrying arms can include a first outer side arm 103, a second outer side arm 106, a first inner side arm 104, and a second inner side arm 105 that can be joined at a distal end by a distal end connection portion 109. These arms can be laterally separated from one another.

[0083] Each of the four arms can carry a plurality of electrodes 102. For example, each of the four arms can carry electrodes 102 spaced along a length of each of the four arms. Although the high-density electrode catheter 101 depicted in FIG. 2A and FIG. 2B depicts four arms, the high-density electrode catheter 101 can include more or fewer arms. Additionally, although the high-density electrode catheter 101 depicted in FIG. 2A and FIG. 2B depicts 18 electrodes (e.g., 5 electrodes on the first outer side arm 103 and the second outer side arm 106, and 4 electrodes on the first inner side arm 104 and the second inner side arm 105), the catheter can include more or fewer than 18 electrodes. Additionally, the first outer side arm 103 and the second outer side arm 106 can include more or fewer than 5 electrodes, and the first inner side arm 104 and the second inner side arm 105 can include more or fewer than 4 electrodes.

[0084] In some embodiments, the electrodes 102 can be used for diagnostic, therapeutic, and / or mapping procedures. For example, and without limitation, the electrodes 102 can be used for electrophysiology studies, pacing, cardiac mapping, and ablation. In some embodiments, the electrodes 102 can be used to perform monopolar or bipolar ablation. Such monopolar or bipolar ablation can create a particular lesion line or pattern. In some embodiments, the electrodes 102 can receive electrical signals from the heart that can be used for electrophysiology studies. In some embodiments, the electrodes 102 can perform location or positioning sensing functions related to cardiac mapping.

[0085] In some embodiments, the high-density electrode catheter 101 can include a catheter shaft 107. The catheter shaft 107 can include a proximal end and a distal end. The distal end can include a connector 108 that can couple the distal end of the catheter shaft 107 to the proximal end of the planar array. The catheter shaft 107 can define a catheter shaft longitudinal axis aa, as shown in FIG. 2AAs depicted in FIG. 1, the first lateral arm 103, the first medial arm 104, the second medial arm 105, and the second lateral arm 106 can extend generally parallel to the catheter shaft longitudinal axis aa along the catheter shaft. The catheter shaft 107 can be made of a flexible material such that it can be navigated through the tortuous vasculature of a patient. In some embodiments, the catheter shaft 107 can include one or more ring electrodes 111 disposed along the length of the catheter shaft 107. In examples, the ring electrodes 111 can be used for diagnostic, therapeutic, and / or mapping procedures.

[0086] As FIG. 2B As depicted in FIG. 1, the first lateral arm 103, the first medial arm 104, the second medial arm 105, and the second lateral arm 106 can extend generally parallel to the catheter shaft longitudinal axis aa along the catheter shaft. The catheter shaft 107 can be made of a flexible material such that it can be navigated through the tortuous vasculature of a patient. In some embodiments, the catheter shaft 107 can include one or more ring electrodes 111 disposed along the length of the catheter shaft 107. In examples, the ring electrodes 111 can be used for diagnostic, therapeutic, and / or mapping procedures. FIG. 2A and FIG. 2B The arms (or substructure of the arms) including the paddle structures (or multi-arms, carrying electrodes, flexible frames) at the distal end of the catheter as depicted in FIGS. 1-3 are preferably constructed of a flexible or spring-like material (e.g., nitinol) and / or a flexible substrate, as discussed herein. The construction of the arms (including, for example, the length and / or diameter of the arms) and the material can be adjusted or tailored to produce, for example, desired elastic, flexible, foldable, conformable, and stiff characteristics, including one or more characteristics that can vary from the proximal end of an individual arm to the distal end of that arm or between or among multiple arms including the individual paddle structures.

[0087] The foldability of the material (e.g., nitinol) and / or flexible substrate provides an additional advantage of facilitating insertion of the paddle structures into a delivery catheter or introducer, whether during delivery of the catheter into the body or during removal of the catheter from the body at the end of a procedure. In some embodiments, a non-conductive sheath can be disposed over the material (e.g., nitinol) forming the substructure of the arms. In some embodiments, as discussed herein, the non-conductive sheath can include a tube defining a longitudinally extending lumen through which the substructure is disposed. In some embodiments, the tube can be formed of a material including a polymer.

[0088] Among other things, the disclosed catheters and their multiple electrodes can be used to: (1) define regional propagation maps of specific sized areas (e.g., one square centimeter areas) within the atrial wall of the heart; (2) identify complex fractionated atrial electrograms for ablation; (3) identify local focal potentials between electrodes for higher electrogram resolution; and / or (4) more precisely target areas for ablation. These mapping and ablation catheters are configured to conform to and maintain contact with the heart tissue despite the potentially unstable motion of the heart. This enhanced stability of the catheter on the heart wall during heart motion provides more accurate mapping and ablation due to the continued tissue electrode contact.

[0089] Additionally, the catheters described herein can be used for epicardial and / or endocardial applications. For example, the planar array embodiments depicted herein can be used in epicardial procedures, where 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 quickly scan and / or analyze the interior surface of the myocardium and quickly create a high-density map of the electrical properties of the cardiac tissue.

[0090] In some embodiments, the use of the high-density electrode catheter 101 can be susceptible to blood clotting on various portions of the high-density electrode catheter 101. For example, blood clotting can occur on the flexible tip portion 110 and / or on the connector 108 of the high-density electrode catheter 101. Although clotting of blood is discussed herein, in some instances, other materials, such as tissue cells, can collect on the flexible tip portion 110 and / or on the connector 108. If blood clots on the electrodes, the clotting of blood can impair the functionality of the electrodes. Additionally, if the clotted blood dislodges, the clotting of blood on the flexible tip portion 110 and / or on the connector 108 can result in the presence of blood clots. Thus, it is beneficial to prevent blood clotting and / or the accumulation of other materials on the flexible tip portion 110 and / or on the connector 108, which can be achieved through the use of the embodiments discussed in the present disclosure.

[0091] 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 hereby incorporated by reference as if fully set forth herein. While some embodiments of the present disclosure include a flexible tip portion, wherein the flexible tip portion includes diagnostic and / or therapeutic electrodes, embodiments of the present disclosure can include flexible and / or rigid tip portions (e.g., distal assemblies) that can be electrode assemblies or any number of end use therapeutic and / or diagnostic devices in place of or in addition to the flexible tip portion. For example, the tip portion can include ultrasound sensors and / or transducers associated with intracardiac echocardiography (ICE) catheters; lasers, balloons, or any other number of therapeutic and / or diagnostic devices.

[0092] In some embodiments, although not depicted, a magnetic position sensor can be included in the catheter shaft 107 of the high density electrode catheter 101. In some embodiments, the position of the magnetic position sensor can be determined as discussed herein. Based on the position of the magnetic position sensor, the position of the flexible tip portion 110 can be determined. However, in some embodiments, depending on the size of the flexible tip portion 110, the flexible tip portion 110 can extend beyond the range in which the position of the flexible tip portion 110 can be accurately determined by means of the magnetic position sensor disposed in the catheter shaft 107. For example, the longitudinal length of the flexible tip portion 110 can extend beyond the range in which the position of the flexible tip portion 110 can be accurately determined by means of the magnetic position sensor disposed in the catheter shaft 107. Accordingly, as further discussed herein, embodiments of the present disclosure can 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 can be disposed on the flexible tip portion.

[0093] FIG. 3AThese are isometric side and top views of a high-density electrode conduit 120 according to various embodiments of the present disclosure. FIG. 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, more or fewer 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.

[0094] 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.

[0095] In some embodiments, the flexible tip portion 122 may include a magnetic position sensor 209, such as FIG. 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 inFIG. 3A The center electrode 130 can be hollow in the middle, but the magnetic position sensor 209 can be disposed within the center electrode 130. For example, as further depicted in FIG. 3J The center electrode 130 can define a lumen within which the magnetic position sensor 209 is disposed, as further depicted in the middle.

[0096] In some embodiments, the magnetic position sensor 209 can be disposed on and / or in a portion of the flexible tip portion 122. In some embodiments, a distal end portion of the flexible tip portion 122 can define a mounting feature for the magnetic position sensor 209. In some embodiments, the mounting feature can include a cutout in a portion of the flexible tip portion 122, a recess in a portion of the flexible tip portion, a lumen in a portion of the flexible tip portion, etc. In some embodiments, the cutout can be defined in one of the arms 126-1, 126-2, …, 126-5, in the distal coupling 136, in a frame forming one of the arms 126-1, 126-2, …, 126-5, or elsewhere in the flexible tip portion 122.

[0097] In some embodiments, the recess can be defined in one of the arms 126-1, 126-2, …, 126-5, in the distal coupling 136, in a frame forming one of the arms 126-1, 126-2, …, 126-5, or elsewhere in the flexible tip portion 122. In some embodiments, as discussed herein, the center electrode 130 can define a lumen within which the magnetic position sensor 209 is disposed. In some embodiments, the lumen can be formed in other structures included in the flexible tip portion 122. For example, the lumen can be defined in one of the arms 126-1, 126-2, …, 126-5, in the distal coupling 136, in a frame forming one of the arms 126-1, 126-2, …, 126-5, or elsewhere in the flexible tip portion 122. Although some examples of mounting features are provided, examples are not limited thereto and can include other types of mounting features.

[0098] In some embodiments, the magnetic position sensor 209 can be disposed at a distal end of the center arm 126-5. In some embodiments, the magnetic position sensor 209 can sense position and / or orientation with five degrees of freedom (5DOF) or six degrees of freedom (6DOF). As further discussed herein, one or more magnetic position sensors 134-1, 134-2 FIG. 3B) can be disposed within the proximal coupling 128 and / or along a catheter shaft (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 can be indicative of a position and / or orientation of the magnetic position sensors 209, 134-1, 134-2.

[0099] In some embodiments, the longitudinal length of the flexible tip portion 122 can be such that the position of the distal end of the flexible tip portion 122 can not be determined by the magnetic position sensors positioned at the distal end of the catheter shaft. For example, the distal portion of the flexible tip portion 122 can extend beyond the region of magnetic correct position information and software used in determining the position of the flexible tip portion. Thus, the position and / or orientation of the flexible tip portion 122 can not be accurately determined. Accordingly, the position and / or orientation of a magnetic position sensor 209 disposed in the distal end of the flexible tip portion 122 can be determined, which can be used to determine the position and / or orientation of the distal end of the flexible tip portion 122 that can extend beyond the region of magnetic correct position information.

[0100] In some embodiments, the magnetic position sensor 209 can be disposed on a portion of the flexible tip portion 122 that extends beyond the region of magnetic correct position information provided by one or more magnetic position sensors 134-1, 134-2 disposed on the proximal coupling 128 and / or disposed on the distal end of the catheter shaft from which the flexible tip portion 122 extends. Although generally discussed as being disposed on the central arm 126-5, the magnetic position sensor 209 can be located at other locations along the flexible tip portion 122 to enable determination of the position of the flexible tip portion 122.

[0101] In some embodiments, the central electrode 130 can be cylindrical and can extend distally from the central arm 126-5. The central electrode 130 can house the magnetic position sensor 209 FIG. 3J ), while additionally providing the functionality of an electrode 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 the distal coupling 136. The distal coupling 136 can couple the distal ends of the central arm 126-5, the first and second lateral arms 126-1, 126-4, and the first and second medial arms 126-2, 126-3. As previously noted, although discussed with respect to a catheter, the concepts discussed herein can be applied to other medical devices, such as a guidewire. FIG. 3AA distal coupling 136 is depicted, although the distal coupling 136 is not required. For example, the frame forming the flexible tip portion 122 of the high-density electrode catheter 120 can not be coupled together at a location distal from the proximal coupling 128 and / or a distal end of the catheter shaft from which the flexible tip portion 122 extends. In some embodiments, although not depicted, a magnetic position sensor can 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 of the uncoupled frame.

[0102] In some embodiments, although not depicted, the center electrode 130 can include one or more electrodes disposed on an exterior of the magnetic position sensor 209. For example, in some embodiments, the center electrode 130 can be split into multiple portions (e.g., top half, bottom half) disposed about the center electrode 130. In some embodiments, one or more point electrodes can be disposed on the magnetic position sensor 209. In some embodiments, the center electrode 130 can be formed of a flexible circuit including one or more electrodes formed thereon, which can be disposed on the magnetic position sensor 209.

[0103] In some embodiments, the center arm 126-5 can include an elongation feature 140. As FIG. 3A depicted in FIG. 1 1, the elongation feature 140 can include a non-linear elongation feature 140. The non-linear elongation feature 140 can include a bend in a portion of the center arm 126-5 that can be straightened, allowing for an increase in the longitudinal length of the center arm 126-5 when the bend is in a straightened configuration. For example, in some embodiments, the high-density electrode catheter 120 can be introduced into the body via a sheath. When the high-density electrode catheter 120 is disposed in the sheath, it can be in a stored state, in which the distance between each of the longitudinal extension arms is reduced. This can result in an increase in the stored longitudinal length of the flexible tip portion 122 relative to the deployed length of the device, as FIG. 3A depicted in FIG. 1 1.

[0104] As depicted, the first and second lateral arms 126-1, 126-4 and the first and second medial arms 126-2, 126-3 have bends (e.g., elbows) along their longitudinal lengths, causing them to splay laterally. For example, in the case of the second lateral arm 126-4, the arm includes a proximal bend 142-1 and a distal bend 142-2. When these bends 142-1, 142-2 are straightened, the longitudinal length of the second lateral arm 126-4 can increase as the flexible tip portion 122 is contracted into the storage state. By having the central arm 125-5 include an elongation feature 140 (in this embodiment, the central arm 125-5 includes a non-linear elongation feature 140), the central arm 125-5 can elongate with the first and second lateral arms 126-1, 126-4 and the first and second medial arms 126-2, 126-3, preventing the central arm 126-5 from pulling the flexible tip portion 122 out of alignment when in the storage state. Without the elongation feature 140, in the storage state, the lengths of the first and second lateral arms 126-1, 126-4 and the first and second medial arms 126-2, 126-3 would elongate while the length of the central arm 126-5 would remain constant, causing a portion of the flexible tip portion 122 to fold over onto itself.

[0105] As depicted, the proximal coupler 128 can include a distal coupler head 144. In some embodiments, the distal coupler head 144 can be a flush distal coupler head 144. In some embodiments, the distal coupler head 144 can include one or more irrigation ports 146-1, 146-2 configured to discharge fluid (e.g., irrigation fluid). For example, in some embodiments, the irrigation ports 146-1, 146-2 can be disposed such that they dispense fluid in a manner that substantially covers the flexible tip portion 122 with fluid. In some embodiments, the irrigation ports 146-1, 146-2 can be configured to dispense fluid over 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 can be prone to blood clotting. Accordingly, embodiments of the present disclosure can 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 irrigation features associated with the proximal coupler 128 and its distal coupler head 144 can include one or more features discussed with respect to U.S. Patent Application No. 15 / 585,859, which is incorporated by reference herein as if fully set forth herein.

[0106] As discussed above with respect to the proximal coupler 128, the distal coupler head 144 can include one or more irrigation ports 146-1, 146-2 configured to discharge fluid (e.g., irrigation fluid). For example, in some embodiments, the irrigation ports 146-1, 146-2 can be disposed such that they dispense fluid in a manner that substantially covers the flexible tip portion 122 with fluid. In some embodiments, the irrigation ports 146-1, 146-2 can be configured to dispense fluid over 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 can be prone to blood clotting. Accordingly, embodiments of the present disclosure can 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 irrigation features associated with the proximal coupler 128 and its distal coupler head 144 can include one or more features discussed with respect to U.S. Patent Application No. 15 / 585,859, which is incorporated by reference herein as if fully set forth herein. FIG. 3BAs depicted, the proximal coupling 128 can include a connector stem portion 150 that can be inserted into a lumen defined by the catheter shaft. In some embodiments, the connector stem portion 150 can define a first sensor recess 148-1 and a second sensor recess 148-2 on an outer surface 152 of the connector stem portion 150. FIG. 3A In some embodiments, the first sensor recess 148-1 and the second sensor recess 148-2 can be angled relative to one another and / or relative to a longitudinal axis of the high density electrode catheter 120. In some embodiments, the first sensor recess 148-1 and the second sensor recess 148-2 and the magnetic position sensors 134-1, 134-2 can include those features discussed with respect to U.S. Patent Application No. 15 / 585,859, which is hereby incorporated by reference as if fully set forth herein. The configuration of the magnetic position sensors 134-1, 134-2 can allow for determination of the position and / or orientation of the proximal coupling 128, and thereby the high density electrode catheter 120, in six degrees of freedom.

[0107] In some embodiments, although not depicted, additional electrodes can be provided along the distal portions of the arms 126-1, 126-2, 126-3, 126-4, as indicated by arrows 156-1, 156-2. For example, although not depicted, the electrodes 124 can be provided along the entire length of the arms 126-1, 126-2, 126-3, 126-4. FIG. 1B Although electrodes 124 are depicted that are linearly aligned with one another along linear portions of the arms 126-1, 126-2, 126-3, 126-4, embodiments of the present disclosure can benefit from additional electrodes provided along the regions of the arms 126-1, 126-2, 126-3, 126-4 indicated by arrows 156-1, 156-2.

[0108] In some embodiments, the electrodes provided on the high density electrode catheter 120 (e.g., one or more of the electrodes 124, 130) can be used for various diagnostic and / or therapeutic purposes, including, for example, but not limited to, cardiac mapping and / or ablation. In some embodiments, the ablation performed by the electrodes can include a plurality of different types of ablation. For example, the ablation performed by the electrodes can include monopolar and / or bipolar radiofrequency ablation and / or electroporation, as previously discussed herein.

[0109] In some embodiments, the flexible tip portion 122 can be an electrode assembly configured for use as a bipolar electrode assembly in bipolar-based electroporation therapy. Specifically, as described above, one or more of the electrodes 124 and / or the center electrode 130 provided on the flexible frame workpiece can be individually electrically coupled to FIG. 3CThe generator 56 depicted in FIG. 1 is configured to selectively energize (e.g., by the electroporation generator 56 and / or the computer system 64) with opposite polarity to create an electrical potential and corresponding electric field therebetween for IRE treatment. That is, one or more of the electrodes 124, 130 is configured to function as a negative electrode, while the other is configured to function as a positive electrode. One or more of the electrodes 124, 130 can be any suitable electroporation electrode. In example embodiments, one or more of the electrodes 124, 130 can be ring electrodes. One or more of the electrodes 124, 130 can have any other shape or configuration.

[0110] It should be appreciated that the shape, size, and / or configuration of one or more of the electrodes 124, 130 can affect various parameters of the electroporation treatment applied. For example, increasing the surface area of one or more of the electrodes 124, 130 can decrease the applied voltage required to cause the same level of tissue destruction. Although only reference is made to the electrodes 124 in the discussion, the discussion herein can apply to any of the electrodes depicted on the flexible tip portion 122 of the high-density electrode catheter 120. While the electrodes 124, 130 disposed on the flexible tip portion 122 are described as bipolar electrode assemblies, it should be appreciated that, in some embodiments, the electrodes 124, 130 disposed on the flexible tip portion 122 can be configured as monopolar electrode assemblies, with a patch electrode (e.g., the return electrode 50) used as a return or neutral electrode.

[0111] FIG. 3A is a side view of the high-density electrode catheter 120 depicted in FIG. 1, in accordance with embodiments of the present disclosure. FIG. 3B and FIG. 3C is a side view of the high-density electrode catheter 120 depicted in FIG. 1, in accordance with embodiments of the present disclosure. As depicted, the flexible tip portion 122 can extend distally from the proximal coupling 128. In some embodiments, a distal end of the distal coupling head 144 can include a cross slot 157 through which the first and second lateral arms 126-1, 126-4 and the first and second medial arms 126-2, 126-3 can extend. As further depicted, the first and second lateral arms 126-1, 126-4 and the first and second medial arms 126-2, 126-3 can extend distally from the distal coupling head 144 from a plane bisecting a longitudinal axis a-a of the distal coupling head 144 and the connecting stem portion 150.

[0112] In some embodiments, the central arm 126-5 can extend from the distal coupling head 144 below the longitudinal axis a-a and below the point at which the first and second lateral arms 126-1, 126-4 and the first and second medial arms 126-2, 126-3 extend from the distal coupling head 144. In some embodiments, the central arm 126-5 can include an elongation feature 140. For example, the central arm 126-5 can exit the distal end of the distal coupling head 144 and can extend distally and upwardly, rising through the plane defined by the first and second lateral arms 126-1, 126-4 and the first and second medial arms 126-2, 126-3. With reference to FIG. 3D , the longitudinal axis a-a can extend through the plane defined by the first and second lateral arms 126-1, 126-4 and the first and second medial arms 126-2, 126-3. Then, after reaching the apex 158, the central arm 126-5 can extend downwardly toward the plane defined by the arms 126-1, 126-2, 126-3, 126-4. As discussed previously, when the flexible frame is in the stored configuration, the longitudinal lengths of the arms 126-1, 126-2, …, 126-5 can extend, and the bend in the elongation feature 140 can flatten, allowing the central arm 126-5 to extend.

[0113] FIGS. 3A-3C is an isometric top and side view of a high-density electrode catheter 120' depicted in FIG. 12B, in accordance with an embodiment of the present disclosure. FIG. 3D is an isometric top and side view of a high-density electrode catheter 120' depicted in FIG. 12B, in accordance with an embodiment of the present disclosure. FIG. 5A depicts a third flush port 146-3 and a fourth flush port 146-4 defined in a distal face of the distal coupling head 144. In some embodiments, the distal coupling head 144 can define a lumen 160 into which adhesive can be injected to fill the internal cavities of the proximal connection portion of the underlying structure housing the arms 126-1, 126-2, …, 126-5, as further depicted herein. In some embodiments, in embodiments in which the flexible tip portion includes six arms, the lumen 160 can allow for insertion of a sixth arm, as depicted and discussed with respect to FIG. 3E .

[0114] FIGS. 3A-3D is an isometric top and side view of a high-density electrode catheter 120' depicted in FIG. 12B, in accordance with an embodiment of the present disclosure. FIG. 3F is an isometric top and side view of a high-density electrode catheter 120' depicted in FIG. 12B, in accordance with an embodiment of the present disclosure. FIGS. 3A-3E is an isometric top and side view of a high-density electrode catheter 120' depicted in FIG. 12B, in accordance with an embodiment of the present disclosure. FIG. 3GThe isometric bottom and side views of the high-density electrode conduit 120′ 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 ( FIG. 3F A hollow cylindrical tube extending above the distal end of the tube.

[0115] 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. FIG. 3G 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.

[0116] 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 an 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.

[0117] Fluid delivery pipes 174-1, 174-2, 174-3, and 174-4 can be confined within the mounting portion 176. Regarding... FIG. 3F This was discussed further. For example... FIG. 3G 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. FIGS. 3A-3F According to embodiments of this disclosure FIG. 3H The high-density electrode conduit 120″ is depicted in isometric top and side views, with the mounting portion 176 further depicted. FIGS. 3A-3G According to embodiments of this disclosure FIG. 3AIsometric bottom and side views of the high-density electrode catheter 120" depicted in FIG. 26, with the mounting portion 176 further depicted. In some embodiments, the mounting portion 176 can be disposed on the distal end of the connecting stem portion 150. As depicted, the mounting portion 176 can be cylindrical and can define delivery tubes 174-1, 174-2, 174-3, 174-4 through which irrigation fluid can flow and be directed out of irrigation ports 146-1, 146-2, 146-3, 146-4, respectively. FIG. 3D and FIG. 3F ).

[0118] In some embodiments, the mounting portion 176 can define a receiving lumen in which the connecting stem portion 150 can be received. In some embodiments, a plurality of adhesive apertures 180-1, 180-2, 180-3, 180-4 (180-4 hidden from view) can be defined on an exterior surface of the mounting portion 176. Adhesive can be injected into the adhesive lumen 178 and can flow through an interior portion of the mounting portion 176 and into the adhesive apertures 180-1, 180-2, 180-3, 180-4, securing the mounting portion 176 to the connecting stem portion 150 and the manifold portion 162 ( FIG. 3M ). As further depicted, the proximal ends of the arms 126-1, 126-2, 126-3, 126-4, 126-5 can be disposed within the distal end of the mounting portion 176 such that they are fixed in place relative to the mounting portion 176.

[0119] In some embodiments, the mounting portion 176 can include an irrigation through-hole 182, further depicted in FIG. 3Q The irrigation through-hole 182 can be fluidically coupled with an irrigation lumen 280 defined in the connecting stem portion 150 ( FIG. 3I ). For example, the irrigation lumen 280 can be defined in the connecting stem portion 150 and can extend longitudinally through the connecting stem portion 150. The irrigation lumen 280 can provide irrigation fluid to the through-hole 182 and, thus, to the fluid input 168.

[0120] FIG. 3J Isometric top and side views of a flexible substructure 190 of the high-density electrode catheter 120 depicted herein according to embodiments of the present disclosure. FIGS. 3A-3I Isometric top and side views of a flexible substructure 190 of the high-density electrode catheter 120 depicted herein according to embodiments of the present disclosure. FIG. 3KThe 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... FIG. 3I 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.

[0121] Further reference FIG. 3M 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.

[0122] 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 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.FIG. 3L Further discussion is needed.

[0123] FIG. 3H According to embodiments of this disclosure FIG. 3M Isometric bottom and side views of the high-density electrode conduit 120″′ 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. FIG. 3M As depicted, the opposite side of the mounting portion 176 may include a mounting cutout 225.

[0124] FIG. 3F 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 directed by a manifold portion 162 (…). FIG. 3P Allocation. Regarding FIG. 3N Other aspects of the installation process were discussed.

[0125] FIG. 3M These are isometric bottom and side views of the near end of a flexible substructure 190 according to an embodiment of the present disclosure. FIG. 3Mis a bottom view of a proximal end of a flexible understructure 190 according to embodiments of the present disclosure. As depicted, the proximal end of each of the frames 192-1, 192-2, …, 192-5 can include a frame mounting portion 206-1, 206-2, …, 206-5. The frame mounting portions 206-1, 206-2, …, 206-5 can be configured to engage with the mounting portion 176 in order 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 the mounting portion 176. In some embodiments, the frame mounting portions 206-1, 206-2, …, 206-5 can include a clip portion that engages a corresponding clip portion defined in the mounting portion 176 with spring tension provided by the frames 192-1, 192-2, …, 192-5. In some embodiments, the flexibility associated with the frames 192-1, 192-2, …, 192-5 can provide the spring tension.

[0126] In some embodiments, the central frame mounting portion 206-5 can include a spring clip 228 relative to the central frame 192-5. As depicted, a spring post 230 can extend proximally relative to the central frame 192-5 and can be connected to the spring clip 228 at its proximal end via a spring connector. In some embodiments, a spring gap 234 can be defined between the spring post 230 and the spring clip 228. In operation, as the central frame mounting portion 206-5 is pushed through the mounting lumen 269( FIG. 3O ), the spring gap 234 can provide space for the spring clip 228 to compress toward the spring post 230, as discussed further herein. As discussed further, the mounting lumen 269 can have a shape complementary to the cross-section of the central frame 192-5, allowing the central frame mounting portion 206-5 to be pushed through the mounting lumen 269.

[0127] Further reference is made to FIG. 3M When the spring clip 228 is in the engaged configuration, the spring clip distal end 232 of the spring clip 228 can protrude beyond the corresponding frame edge 238. As the spring clip 228 is pushed through the corresponding mounting lumen 269( FIG. 3P ), the spring clip 228 can be pushed toward the spring post 230 such that the spring clip distal end 232 becomes more flush with the corresponding frame edge 238, allowing the central frame mounting portion 206-5 to be pushed through the mounting lumen 269.

[0128] With respect to the first inner side frame 192-2 and the second inner side frame 192-3, their respective frame mounting portions 206-2, 206-3 can include frame clamps, as depicted. For simplicity, discussion of the frame clamps associated with the frame mounting portions will be limited to the second inner side mounting portion 206-3. The first inner side mounting portion 206-2 can include the same or similar features as the second inner side mounting portion 206-3. As depicted, the second inner side mounting portion 206-3 can include a clamp cutout 240 defined in an inner edge 242 of the second inner side frame 192-3. In some embodiments, the clamp cutout 240 can be complementary to an inner side locking post 260 defined in the mounting portion 176, as discussed herein with reference to FIGS. 1-3. For example, the inner side locking post 260 can be disposed in the clamp cutout 240, thereby locking the second inner side mounting portion 206-3 in place. FIG. 3P Further depicted and discussed. For example, the inner side locking post 260 defined in the mounting portion 176 can be disposed in the clamp cutout 240, thereby locking the second inner side mounting portion 206-3 in place.

[0129] As further depicted, the second inner side mounting portion 206-3 can include a ramp portion 244 that can enable the second inner side mounting portion 206-3 to deflect over the inner side locking post 260 when the second inner side frame 192-3 is pushed into the mounting portion 176. In some embodiments, the second inner side frame 192-3 and the first inner side frame 192-2 can be connected and thus can be pushed into the mounting portion 176 simultaneously. As depicted, the first inner side mounting portion 206-2 and the second inner side mounting portion 206-3 can deflect away from each other as their respective ramp portions contact the inner side locking post 260.

[0130] As depicted, the second inner side mounting portion 206-3 can also include a retaining shelf 246 that can be contacted by an engagement tab 250 disposed on an opposite proximal inner edge of the second outer side mounting portion 206-4, as discussed herein. With respect to the second outer side mounting portion 206-4, the second outer side mounting portion 206-4 can include similar features as the second inner side mounting portion 206-3. For example, the second outer side mounting portion 206-4 can include a clamp cutout 248 and a ramp portion 252 for engagement with an outer side locking post 262 disposed in the mounting portion 176.

[0131] As discussed further herein, in some embodiments, the first and second inboard mounting portions 206-2, 206-3 can be inserted into the mounting portion 176 first, and then the first and second outboard mounting portions 206-1, 206-4 can be inserted. In the case of the second outboard mounting portion 206-4 and the second inboard mounting portion 206-3, the engagement tab 250 can press against the retaining shelf 246 such that a retaining force is exerted between the engagement tab 250 and the retaining shelf 246, thereby ensuring that the clamp cutout 240, 248 remains engaged with its respective locking post 260, 262.

[0132] FIG. 3M is a bottom view of a proximal end of the flexible understructure 190 disposed in the mounting portion 176, depicted in cross-sectional view, according to embodiments of the present disclosure. As depicted and as previously noted, the mounting portion can include inboard and outboard locking posts 260, 262. As discussed, in some embodiments, the first and second inboard frames 192-2, 192-3 can be inserted into the mounting portion 176. In some embodiments, an extension (e.g., an electrical wire) can be attached to the proximal end of each inboard and / or outboard mounting portion 206-1, 206-2, …, 206-4, and can pass through the openings 264, 268 (also depicted in FIG. 3P ) defined between the inboard and outboard locking posts 260, 262, 266. In some embodiments, the extension can be pulled proximally to help urge the inboard / outboard mounting portions 206-1, 206-2, …, 206-4 proximally to engage with each respective inboard / outboard locking post 260, 262.

[0133] As discussed, in some embodiments, when the inboard mounting portions 206-2, 206-3 are urged into place such that the clamp cutout 240 is engaged with the inboard locking post 260, the ramped portion 244 can begin to contact the outboard distal edge of the locking post 260. The contact between the ramped portion 244 and the distal edge of the locking post 260 can cause the second inboard mounting portion 206-3 to separate from the first inboard mounting portion 206-2. Although not labeled, the ramped portion associated with the first inboard mounting portion 206-2 can contact the respective proximal edge of the locking post 260, thereby also causing the first inboard mounting portion 206-2 to separate from the second inboard mounting portion 206-3. For example, in some embodiments, under the configuration depicted in FIG. 3M , the first and second inboard frames 192-2, 192-3 can be naturally biased.

[0134] Upon insertion of the inner side mounting portions 206-2, 206-3 into the mounting portions 176, the first inner side frame 192-2 and the second inner side frame 192-3 can deflect from their natural biased state. When the first inner side frame 192-2 and the second inner side frame 192-3 are inserted into the mounting portions 176 to the point where their respective clamp cutouts (e.g., clamp cutout 240) are aligned with the inner side locking post 260, the first inner side frame 192-2 and the second inner side frame 192-3 can return to their natural biased state, thereby causing them to lock into place relative to the inner side locking post 260.

[0135] In some embodiments, the first outer side frame 192-1 and the second outer side frame 192-4 can be inserted into respective openings 264, 268 defined between the inner side locking post 260 and the outer side locking posts 262, 266. In some embodiments, the first outer side mounting portion 206-1 and the second outer side mounting portion 206-4 can be inserted into the openings 264, 268 after the first inner side mounting portion 206-2 and the second inner side mounting portion 206-3 have been inserted into the openings 264, 268 and locked into place relative to the inner side locking post 260. Upon insertion of the first outer side mounting portion 206-1 and the second outer side mounting portion 206-4 into their respective openings 264, 268, the ramped portions 252, 253 of each of the first outer side mounting portion 206-1 and the second outer side mounting portion 206-4 can contact the inner distal edge of each of the respective outer side locking posts 262, 266, thereby causing the first outer side mounting portion 206-1 and the second outer side mounting portion 206-4 to deflect inwardly toward one another.

[0136] Each of the first outer side mounting portion 206-1 and the second outer side mounting portion 206-4 can be inserted proximally through the respective openings 264, 268 until the respective clamp cutouts 248, 270 of the first outer side mounting portion 206-1 and the second outer side mounting portion 206-4 are aligned with each of the outer side locking posts 262, 266. Upon alignment of the outer side locking posts 262, 266 with each of the first clamp cutout 248 and the second clamp cutout 270, the first outer side mounting portion 206-1 and the second outer side mounting portion 206-4 can laterally expand, thereby causing the first outer side locking post 262 and the second outer side locking post 266 to seat in each of the clamp cutouts 248, 270.

[0137] As previously discussed, each of the first and second lateral mounting portions 206-1, 206-4 can include an engagement tab 250. For simplicity, the discussion of the engagement tab will be limited to the second lateral mounting portion 206-4, but the first lateral mounting portion 206-1 includes the same or similar features. As depicted, the engagement tab 250 can engage with the retaining shelf 246 upon insertion of the second lateral mounting portion 206-4 and engagement of the clip cutout 248 with the lateral locking post 262. In some embodiments, the engagement tab 250 can abut the retaining shelf 246, thereby preventing both clip cutouts 240, 248 from disengaging with their respective locking posts 260, 262.

[0138] As depicted, the center frame 192-5 can include a center mounting portion 206-5. In some embodiments, the mounting portion 176 can define a mounting lumen 269 FIG. 3M that extends longitudinally through the mounting portion 176 and is similar in size to the cross-section of the center arm 192-5. In some embodiments, the center mounting portion 206-5 can be advanced in the proximal direction through the longitudinally extending mounting lumen 269 in the mounting portion 176. As the center mounting portion 206-5 is advanced through the mounting lumen 269 in the mounting portion 176, the spring clip 236 can be compressed toward the spring post 230 until the spring clip passes through the mounting lumen 269, allowing the spring clip 236 to expand 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.

[0139] As discussed with respect to FIG. 3A Further depicted, in some embodiments, wire lumens 271, 273 can be defined in the distal face of the mounting portion 176. In some embodiments, the wire lumens 271 can provide space for routing electrical wires to the flexible tip portion 122 FIG. 3Q as discussed herein.

[0140] FIG. 3R is an isometric distal view of the connecting rod portion 150 according to embodiments of the present disclosure. FIG. 3G is an isometric proximal view of the connecting rod portion 150 depicted in FIG. 3F As depicted, the connecting rod portion 150 can include a flush lumen 280 extending therethrough. As previously discussed, the flush lumen 280 can provide flush fluid from the proximal end of the connecting rod portion 150 to the fluid input 168, as discussed with respect to FIG. 3QAs further described herein, the connecting rod portion 150 may define a first sensor recess 148-1 and a second sensor recess 148-2, as discussed herein. 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.

[0141] like FIG. 3A 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. FIG. 3J ), and a magnetic position sensor 209 disposed on the flexible tip portion 122. FIG. 3J It may be associated with other devices and / or sensors disposed on the flexible tip portion 122.

[0142] Further reference FIG. 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. FIG. 3S 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. FIG. 3T and FIG. 3A To be further described.

[0143] In some embodiments, the magnetic position sensor mount 211 can be used as FIG. 3JThe 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. FIG. 3S 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.

[0144] 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... FIG. 3S To better depict it.

[0145] FIG. 3J According to embodiments of this disclosure FIG. 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. FIG. 3A 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.

[0146] In some embodiments, a dual-lumen tube can be used to cover portions of the flexible underlying structure along which electrodes are disposed. For example, in some embodiments, at least one electrical wire can be associated with each electrode, which can be routed proximally along the flexible tip portion. Using a dual-lumen tube for portions of the flexible underlying structure along which electrodes are disposed allows the electrical wires to be disposed in a first lumen of the dual-lumen tube, with a frame (e.g., the first medial frame 192-2) routed in a second lumen of the dual-lumen tube. For portions of the flexible underlying structure that do not include electrodes, in some embodiments, a single-lumen tube 290 can be used to cover the flexible underlying structure, as depicted for the first lateral arm 126-1 and the second lateral arm 126-4.

[0147] In some embodiments, as discussed herein, the flexible underlying structure 190' can include a magnetic position sensor mount 211 disposed on the distal portion 208 of the flexible underlying structure 190'. In some embodiments, the magnetic position sensor mount 211 can house a magnetic position sensor 209. For example, the magnetic position sensor mount 211 can define a longitudinally extending slot 213 in which the magnetic position sensor 209 can be disposed.

[0148] In some embodiments, the magnetic position sensor mount 211 can be used as an electrode underlying structure for the central electrode 130, as depicted in FIG. 1. In some embodiments, the magnetic position sensor 209 can be disposed within the slot 213, and a tubular conductive layer (e.g., the central electrode 130) can be disposed over an outer surface of the magnetic position sensor mount 211. FIG. 3S

[0149] In some embodiments, the magnetic position sensor mount 211 can be coupled with the distal coupling 136. In some embodiments, the distal coupling 136 and the magnetic position sensor mount 211 can be formed from a single piece of material. The magnetic position sensor mount 211 can be connected to a distal end of the central frame 192-5, and thus can connect the central frame 192-5 to the distal coupling 136. In some embodiments, the magnetic position sensor mount 211 can include a keyed slot 217 that can be configured to accommodate a distal end of the central frame 192-5, as better depicted in FIG. 1. For example, as depicted, the keyed slot 217 can be a shape that is complementary to a shape of the distal end of the central frame 192-5. As depicted, the keyed slot 217 can be a semicircular slot defined in the magnetic position sensor mount 211. FIG. 3A

[0150] ​​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 (…) FIG. 3S 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 190′. The keyed connection between the slot 217 and the far end of the central frame 192-5 prevents the central frame 192-5 from being pulled away from the magnetic position sensor mount 211.

[0151] like FIG. 3T 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.

[0152] FIG. 3J According to embodiments of this disclosure FIG. 3A The image shows a bottom isometric view of the distal portion 208″′ of the flexible substructure 190″′, 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 medial 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 located distal to 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.

[0153] 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 FIG. 3S 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.

[0154] like FIG. 3U 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.

[0155] FIG. 3J According to embodiments of this disclosure FIG. 3A The image depicts a bottom isometric view of the distal portion 208″′ of the flexible substructure 190″′, 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 in the magnetic position sensor mount 211. As depicted, the magnetic position sensor 209 can be positioned along the distal portion 208″′ of the flexible substructure 190″′.

[0156] 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 ( FIG. 3Uposition and / or orientation of the distal portion 208"'. As depicted, the magnetic position sensor 209 can be axially aligned with a longitudinal axis of the central frame 192-5. However, in some embodiments, the magnetic position sensor 209 can be tilted relative to the central frame 192-5. For example, the magnetic position sensor 209 can be tilted laterally relative to a longitudinal axis of the central frame 192-5 and / or the flexible tip portion 122 or a catheter shaft attached to the flexible tip portion 122. In some embodiments, the magnetic position sensor 209 can be tilted upwardly or downwardly relative to a longitudinal axis of the central frame 192-5 and / or the flexible tip portion 122 or a catheter shaft attached to the flexible tip portion 122.

[0157] Although the magnetic position sensor 209 is shown positioned along the distal portion 208"' (and, in particular, distally from the central frame 192-5), the magnetic position sensor 209 can be disposed at other locations along the flexible substructure. In some embodiments, the magnetic position sensor 209 can be disposed proximally or distally relative to its position depicted in FIG. 3U . In some embodiments, the magnetic position sensor 209 can be disposed laterally relative to its position depicted in FIG. 4 . For example, in some embodiments, the magnetic position sensor 209 can be disposed at different locations along the distal portion 208"' while still being able to sense a position and / or orientation of the distal portion 208"'.

[0158] In some embodiments, the magnetic position sensor 209 can be positioned along at least one of the first outer lateral frame 192-1 and the second outer lateral frame 192-4 and / or along at least one of the first inner lateral frame 192-2 and the second inner lateral frame 192-3. In some embodiments, the magnetic position sensor can be disposed on one or more of the inner and / or outer lateral frames to determine a 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. FIG. 4 FIGS. 3A-3C illustrate embodiments in which a magnetic position sensor is placed at different locations on a distal portion of a flexible tip portion of a catheter.

[0159] FIG. 4 is a top view of a catheter 300 having a flexible tip portion 302 with a pair of magnetic position sensors 304-1, 304-2 disposed on a distal portion of the flexible tip portion 302, in accordance with embodiments of the present disclosure. The catheter 300 can include a longitudinally extending catheter shaft 306 with one or more ring electrodes 308-1, 308-2 disposed thereon. In some embodiments, the ring electrodes 308-1, 308-2 can be used for position sensing, diagnostic, and / or therapeutic purposes. Although described with respect to a pair of ring electrodes 308-1, 308-2, in some embodiments, the catheter 300 can include a single ring electrode 308-1, 308-2 or more than two ring electrodes 308-1, 308-2. FIG. 7One or more ring electrodes 308-1, 308-2 are discussed, but other embodiments discussed herein (e.g., those discussed with respect to FIGS. 5, 6, and FIG. 3A

[0160] As depicted, a plurality of electrodes 314 can be disposed on the arms 312-1, 312-2, 312-3, 312-4. Although a total of 16 electrodes 314 are shown on the arms 312-1, 312-2, 312-3, 312-4, the number of electrodes disposed on the arms can be greater than or less than 16 electrodes. In some embodiments, the plurality of electrodes 314 can be used for position sensing, diagnostic, and / or therapeutic purposes. In some embodiments, one or more magnetic position sensors can be disposed on one of the medial and / or lateral arms 312-1, 312-2, 312-3, 312-4. For example, as depicted, a pair of magnetic position sensors 304-1, 304-2 can be disposed on distal portions of the first lateral arm 312-1 and the second lateral arm 312-4. Although the pair of magnetic position sensors 304-1, 304-2 are shown as being disposed on distal portions of the first lateral arm 304-1 and the second lateral arm 304-2, the magnetic position sensors 304-1, 304-2 can be disposed on other portions of the flexible tip portion 302 (e.g., the first medial arm 312-2 and the second medial arm 312-3).

[0161] In some embodiments, the magnetic position sensors 304-1, 304-2 can be formed via a plurality of windings made around the first lateral arm 312-1 and the second lateral arm 312-4 via an electrical wire formed of an electrically conductive material (e.g., copper). In some embodiments, the plurality of windings can be formed over individual sensor cores 316-1, 316-2 that can be formed of a magnetically permeable material. For example, in some embodiments, a sensor core 316-1, 316-2 can be disposed over a portion of one of the arms 312-1, 312-2, 312-2, 312-4, and a plurality of windings of an electrically conductive wire can be made over the sensor core 316-1, 316-2.

[0162] ​In some embodiments, one or more magnetic position sensors can be formed on an underlying structure associated with one of the arms 312-1, 312-2, 312-3, 312-4. For example, although the magnetic position sensors 304-1, 304-2 are shown disposed about the arms 312-1, 312-4, the magnetic position sensors can be disposed on an underlying structure of one or more of the arms 312-1, 312-2, 312-3, 312-4. For example, the underlying structure forming the arms 312-1, 312-2, 312-3, 312-4 can include one or more slots in which the magnetic position sensors can be disposed. Alternatively and / or additionally, the magnetic position sensors can be wrapped about the underlying structure forming one or more of the arms 312-1, 312-2, 312-3, 312-4.

[0163] In some embodiments, one or more electrodes can be disposed over one or more of the magnetic position sensors 304-1, 304-2, as discussed with respect to FIG. 5A For example, in some embodiments, the one or more electrodes can define a lumen through which one or more of the magnetic position sensors 304-1, 304-2 extend. In some embodiments, electrodes can 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 can be disposed over only a portion (e.g., a top half and / or a bottom half) of the magnetic position sensors 304-1, 304-2. In some embodiments, one or more point electrodes can be disposed on one or more of the magnetic position sensors. In some embodiments, a flexible circuit including one or more electrodes disposed thereon can be disposed over one or more of the magnetic position sensors 304-1, 304-2.

[0164] As depicted, the magnetic position sensors 304-1, 304-2 can be formed on a portion of the outer arms 312-1, 312-4 that diverge relative to a longitudinal axis defined by the catheter 300. In some embodiments, the magnetic position sensors 304-1, 304-2 can be electrically coupled with the computing system 20 via one or more electrical wires 318 (e.g., one or more twisted pairs). As depicted, in some embodiments, the electrical wires 318 can not be enclosed via a lumen (e.g., a dual lumen) associated with one of the arms 312-1, 312-2, 312-3, 312-4. The electrical wires 318 can extend proximally from each of the magnetic position sensors 304-1, 304-2 between the first inner arm 312-2 and the second inner arm 312-3 and along the catheter shaft 306. In some embodiments, as previously discussed herein, the flexible tip portion 302 can include a central arm along which the electrical wires 318 can extend.

[0165] In some embodiments, electrical wires 318 can extend along one of the first and second lateral outer arms 312-1, 312-4 and / or the first and second lateral inner arms 312-2, 312-3. In some embodiments where the electrical wires travel down one or more of the arms 312-1, 312-2, 312-3, 312-4, it can be beneficial to maintain symmetry between the arms 312 along which the electrical wires extend. For example, it can be beneficial to have one set of electrical wires extend down the first lateral outer arm 312-1 and another set of electrical wires extend down the second lateral outer arm 312-4; and / or to have one set of electrical wires extend down the first lateral inner arm 312-2 and another set of electrical wires extend down the second lateral inner arm 312-3. By maintaining symmetry between the arms 312 along which the electrical wires extend, it can be possible to maintain symmetry in the deflection of the arms 312. For example, if the electrical wires associated with the magnetic position sensors 304-1, 304-2 extend along the first lateral outer arm 312-1 and the first lateral inner arm 312-2, the deflection of the flexible tip portion 302 can become unbalanced due to the increased mechanical rigidity of the side of the flexible tip portion 302 that includes the electrical wires (e.g., the first lateral outer arm 312-1 and the second lateral outer arm 312-2).

[0166] FIG. 3D is an isometric view of a high-density electrode catheter 320 including six longitudinally extending arms 322-1, 322-2,..., 322-6 in accordance with embodiments of the present disclosure. In some embodiments, the high-density electrode catheter 320 can include a flexible tip portion 324 formed by first and second lateral outer arms 322-1, 322-6, first and second lateral inner arms 322-3, 322-4, and first and second medial arms 322-2, 322-5. As depicted, each of the arms 322-1, 322-2,..., 322-6 can carry a plurality of electrodes 326. In some embodiments, each of the arms 322-1, 322-2,..., 322-6 can carry seven electrodes 326, allowing for an array of 42 electrodes 326 to be disposed on the flexible tip portion 324. In some embodiments, a greater or lesser number of electrodes 326 can be disposed on the flexible tip portion 324.

[0167] In some embodiments, the flexible tip portion 324 can be coupled to a catheter shaft (not depicted) via a proximal coupling 327. In some embodiments, the proximal ends of the arms 322-1, 322-2,..., 322-6 can be disposed in the proximal coupling 328. The design of the proximal coupling 328 can be the same as that of the distal coupling head 144 discussed and depicted with respect to FIG. 3D depicted and discussed with respect to the distal coupling head 144. For example, one of the lateral inner arms 322-3, 322-4 can be disposed in the proximal coupling 328. FIGS. 3A-3DIn the depicted lumen 160. In some embodiments, the proximal coupling 328 may include, regarding FIG. 3D Features that are the same as or similar to the remote coupling head 144 are depicted and discussed. In some embodiments, FIG. 5A 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.

[0168] In some embodiments, the proximal coupling 328 may include a flushing port (e.g., flushing port 330-1). Although in FIG. 3K 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).

[0169] 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.

[0170] 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. FIG. 5A 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.

[0171] 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 FIG. 5B 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.

[0172] FIG. 5A It is an embodiment of the present disclosure comprising six longitudinally extending arms 322-1, 322-2, ..., 322-6. FIG. 3M 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. FIG. 3F 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... FIG. 5B The features discussed in the manifold section 162 described in the text are the same or similar.

[0173] like FIG. 5C and FIG. 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.FIG. 5B As depicted in FIGS. 32-34, a flexible circuit 374 can be disposed along one or more of the arms 322-1, 322-2, 322-3, 322-4, 322-5, 322-6. In some embodiments, the flexible circuit 374 can be disposed along the outer surface of one or more of the arms 322-1, 322-2, 322-3, 322-4, 322-5, 322-6. In some embodiments, the flexible circuit 374 can be disposed along the inner surface of one or more of the arms 322-1, 322-2, 322-3, 322-4, 322-5, 322-6. In some embodiments, the flexible circuit 374 can be disposed along the outer surface and the inner surface of one or more of the arms 322-1, 322-2, 322-3, 322-4, 322-5, 322-6. In some embodiments, the flexible circuit 374 can be disposed along the outer surface of one or more of the arms 322-1, 322-2, 322-3, 322-4, 322-5, 322-6 and the inner surface of one or more of the arms 322-1, 322-2, 322-3, 322-4, 322-5, 322-6. In some embodiments, the flexible circuit 374 can be disposed along the outer surface of one or more of the arms 322-1, 322-2, 322-3, 322-4, 322-5, 322-6 and the outer surface of one or more of the arms 322-1, 322-2, 322-3, 322-4, 322-5, 322-6. In some embodiments, the flexible circuit 374 can be disposed along the inner surface of one or more of the arms 322-1, 322-2, 322-3, 322-4, 322-5, 322-6 and the inner surface of one or more of the arms 322-1, 322-2, 322-3, 322-4, 322-5, 322-6. In some embodiments, the flexible circuit 374 can be disposed along the inner surface of one or more of the arms 322-1, 322-2, 322-3, 322-4, 322-5, 322-6 and the outer surface of one or more of the arms 322-1, 322-2, 322-3, 322-4, 322-5, 322-6. In some embodiments, the flexible circuit 374 can be disposed along the outer surface of one or more of the arms 322-1, 322-2, 322-3, 322-4, 322-5, 322-6 and the outer surface of one or more of the arms 322-1, 322-2, 322-3, 322-4, 322-5, 322-6.

[0174] In some embodiments, the flexible circuit 374 can extend from the proximal end of one or more of the arms 322-1, 322-2, 322-3, 322-4, 322-5, 322-6. For example, in FIGS. 32-34, the flexible circuit 374 is shown extending from the proximal end of the second lateral arm 322-6 toward the distal end of the second lateral arm 322-6. For reference, the flexible circuit 374 is shown disposed over the electrodes 326, however, in use, the flexible circuit 374 can replace the electrodes 326 and electrodes can be disposed on the flexible circuit 374. FIG. 5C and FIG. 5D In some embodiments, the flexible circuit 374 can extend from the proximal end of one or more of the arms 322-1, 322-2, 322-3, 322-4, 322-5, 322-6. For example, in FIGS. 32-34, the flexible circuit 374 is shown extending from the proximal end of the second lateral arm 322-6 toward the distal end of the second lateral arm 322-6. For reference, the flexible circuit 374 is shown disposed over the electrodes 326, however, in use, the flexible circuit 374 can replace the electrodes 326 and electrodes can be disposed on the flexible circuit 374.

[0175] Although not depicted, in some embodiments, one or more electrical traces can be formed in the flexible circuit 374 and one or more electrodes disposed on the flexible circuit 374 can be electrically coupled with the computer system 20 and / or the computer system 64. In some embodiments, the location of the electrodes disposed on the flexible circuit 374 can match the location of the electrodes 326.

[0176] In some embodiments, the flexible circuit 374 can extend along the outer surface of the second lateral arm 322-6 and can transition at the transition point 375 to extend along the top surface of the second lateral arm 322-6 and the bottom surface of the second lateral arm 322-6. In some embodiments, by transitioning the flexible circuit 374 from the outer surface of the second lateral arm 322-6 to the top surface of the second lateral arm 322-6 and the bottom surface of the second lateral arm 322-6, a linear flexible circuit can be used. For example, in some embodiments, the flexible circuit can be disposed entirely along the top surface and / or the bottom surface of the second lateral arm 322-6. However, due to the bend in the proximal portion of the second lateral arm 322-6, the flexible circuit disposed on the top / bottom surface of the second lateral arm 322-6 can need to be configured with a bend that matches the proximal bend portion of the second lateral arm 322-6. Accordingly, embodiments of the present disclosure can provide a flexible circuit 374 that is linear in shape (e.g., extends axially) that can be disposed along the top and bottom of the second lateral arm 322-6 over the bend portion of the second lateral arm 322-6.

[0177] AsFIG. 5B 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 320′ may also include flexible circuitry and corresponding transition points, as discussed with respect to the second outer arm 322-6.

[0178] 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 320′ may also include flexible circuitry and corresponding transition points, as discussed with respect to the second outer arm 322-6.

[0179] Despite about FIG. 5C , FIG. 5D and FIGS. 3A-4 This has been discussed, but flexible circuitry can be implemented in other embodiments discussed herein. For example, at least regarding... FIGS. 6A-11 and FIG. 5C The embodiments of this disclosure discussed may include one or more flexible circuits disposed on a flexible tip portion.

[0180] FIG. 5A Embodiments according to this disclosure are depicted. FIG. 5C The high-density electrode conduit 320′ 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... FIGS. 3N-3Pdepictions of various portions of the frame 342-1, 342-2, 342-3. As further depicted, the proximal portions of the frame 342-1, 342-2, 342-3 can include frame mounting portions 362-1, 362-2, …, 362-5 (362-3, 363-6 hidden from view), as discussed with respect to FIG. 3M depictions of various portions of the frame 342-1, 342-2, 342-3. As further depicted, the proximal portions of the frame 342-1, 342-2, 342-3 can include frame mounting portions 362-1, 362-2, …, 362-5 (362-3, 363-6 hidden from view), as discussed with respect to FIG. 5A depictions of various portions of the frame 342-1, 342-2, 342-3. As further depicted, the proximal portions of the frame 342-1, 342-2, 342-3 can include frame mounting portions 362-1, 362-2, …, 362-5 (362-3, 363-6 hidden from view), as discussed with respect to FIG. 3A depictions of various portions of the frame 342-1, 342-2, 342-3. As further depicted, the proximal portions of the frame 342-1, 342-2, 342-3 can include frame mounting portions 362-1, 362-2, …, 362-5 (362-3, 363-6 hidden from view), as discussed with respect to FIG. 3O depictions of various portions of the frame 342-1, 342-2, 342-3. As further depicted, the proximal portions of the frame 342-1, 342-2, 342-3 can include frame mounting portions 362-1, 362-2, …, 362-5 (362-3, 363-6 hidden from view), as discussed with respect to

[0181] In some embodiments, the frame mounting portion 362-4 associated with the second medial arm 322-4 can include the same features as the frame mounting portion 206-5 depicted in FIG. 3M and can be inserted into a mounting lumen (e.g., the mounting lumen 269 depicted in FIG. 3O In some embodiments, the frame mounting portion (hidden from view) associated with the first medial arm 322-4 can include the same features as the frame mounting portion 206-5 depicted in FIG. 3M and can be inserted into a mounting lumen (e.g., the mounting lumen 275 depicted in FIGS. 5A-5D

[0182] Although one or more magnetic position sensors are not shown on the device depicted in FIG. 4 in some embodiments, one or more magnetic position sensors can be provided on the device. For example, in some embodiments, a device having six longitudinally extending arms can include one or more magnetic position sensors provided thereon. In some embodiments, the magnetic position sensors can be provided on a portion of the first lateral arm 322-1 and the second lateral arm 322-6. For example, in some embodiments, the magnetic position sensors can be provided on the distal portions of the first lateral arm 322-1 and the second lateral arm 322-6 in a configuration similar to the configuration depicted and discussed with respect to FIG. 4 in some embodiments, the one or more magnetic position sensors can be provided on one or more of the distal portions of the first medial arm 322-2 and the second medial arm 322-5 in a configuration similar to the configuration depicted and discussed with respect to FIG. 4 in some embodiments, the one or more magnetic position sensors can be provided on one or more of the distal portions of the first medial arm 322-2 and the second medial arm 322-5 in a configuration similar to the configuration depicted and discussed with respect to FIG. 6A ​Similar or identical features as discussed with respect to the high-density electrode catheter 120 of FIGS. 1-3 can be included on the high-density electrode catheter 120 of FIG. 4, except for the additional first and second intermediate frames 422-2, 422-6.

[0183] FIG. 3A is an isometric view of an understructure 378 of a flexible tip 380 of a high-density electrode catheter according to embodiments of the present disclosure. As depicted, the flexible tip 380 can include a first lateral frame 382-1, a second lateral frame 382-7, a first intermediate frame 382-2, a second intermediate frame 382-6, a first medial frame 382-3, a second medial frame 382-5, and a central frame 382-4. The flexible tip 380 can include similar or identical features as discussed with respect to the high-density electrode catheter 120 of FIGS. 1-3, except for the additional first and second intermediate frames 382-2, 382-6. FIG. 6B FIG. 6B As further depicted and discussed, a proximal mounting portion 394 can be used that can mount all seven frames 382-1, 382-2, …, 382-7.

[0184] As further depicted, the central frame 382-4 can include a non-linear elongation feature 384, as previously discussed herein. The non-linear elongation feature 384 can allow the central frame 382-4 to elongate in response to the flexible tip 380 being in a stored (e.g., collapsed) configuration, as discussed herein. In some embodiments, a distal end of the central frame 382-4 can be connected with the magnetic position sensor mount 386 via a keyed slot 388 and a corresponding keyed distal end of the central frame 382-4 (hidden from view).

[0185] In some embodiments, a magnetic position sensor (not depicted) can be disposed in a longitudinally extending slot 390 defined in the magnetic position sensor mount 386, allowing for 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 can be disposed over the magnetic position sensor mount 386, which can act as an electrode. As further depicted, in some embodiments, the magnetic position sensor mount 386 can be coupled to a distal coupler 392, which can couple the distal ends of each of the frames 382-1, 382-2, …, 382-7. As discussed herein, in some embodiments, no coupler can be used, and the frames 382-1, 382-2, …, 382-7 can be freely disposed relative to one another.

[0186] ​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.

[0187] FIG. 6A According to embodiments of this disclosure FIG. 3N 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...) FIG. 3P and FIGS. 3N-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... FIG. 6B 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...) FIG. 7 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.

[0188] FIG. 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.

[0189] In some embodiments, the spacing between electrodes 404 in each lateral row of electrodes can be in the range of 3 to 5 millimeters. In some embodiments, the spacing between electrodes 404 in each lateral row of electrodes 404 can be 4 millimeters. As depicted, electrodes 404-9, 404-10, 404-11 disposed on the center arm 404-3 can be longitudinally staggered relative to the electrodes disposed on the first and second outer lateral arms 404-1, 404-5 and the first and second inner lateral arms 404-2, 404-4. In some embodiments, electrodes 404-9, 404-10, 404-11 disposed on the center arm 404-3 can be longitudinally staggered relative to the electrodes disposed on the first and second outer lateral arms 404-1, 404-5 and the first and second inner lateral arms 404-2, 404-4 by a length in the range of 1 to 3 millimeters. In some embodiments, the length of the stagger can be 2 millimeters.

[0190] In some embodiments, the electrodes disposed on the center arm 404-3 and the electrodes disposed on the first and second inner lateral arms 404-2, 404-4 can form a reduced spacing pattern represented by the dashed box 408. In some embodiments, the spacing length between each electrode 404-6, 404-10, 404-11, 404-13 intersecting the dashed box 408 can be in the range of 1.5 to 3.5 millimeters. In some embodiments, the spacing length can be 2.8 millimeters. Although specific ranges are provided herein, the ranges can be approximate and the spacing between electrodes can be less than or greater than the ranges provided.

[0191] As further depicted in FIGS. 8A-8E , an additional electrode 410 can be disposed at the distal end of the center arm 404-3. As previously discussed herein, the additional electrode 410 can be used for diagnostic, mapping, and / or therapeutic purposes. In some embodiments, as further discussed herein, a magnetic position sensor can be disposed within the additional electrode 410 to provide mapping capabilities of the distal flexible tip portion 400.

[0192] FIGS. 8A-8E Various electrode spacing configurations of electrodes disposed on a distal flexible tip portion of a high density electrode catheter are depicted in accordance with embodiments of the present disclosure. With respect to FIGS. 8A-8E , the overall dimensions (e.g., a x 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, the ranges can be approximate and the spacing between electrodes can be less than or greater than the ranges provided. In some embodiments, although specific ranges are provided with respect to FIGS. 8A-8E , the ranges can be approximate and the spacing between electrodes can be less than or greater than the ranges provided. In some embodiments, although specific ranges are provided with respect to FIG. 8AA particular number of electrodes is depicted, but embodiments depicted herein can include more or fewer electrodes than depicted.

[0193] As FIG. 8A Depicted in FIG. 42B, a flexible frame 420 formed of a plurality of arms 422-1, 422-2, 422-3, 422-4 (including a first lateral arm 422-1, a first medial arm 422-2, a second medial arm 422-3, and a second lateral arm 422-4) is provided with a plurality of electrodes 424-1, 424-2, 424-3. For ease of reference, only electrodes 424-1, 424-2, 424-3 are referenced herein, however, the principles discussed with respect to electrodes 424-1, 424-2, 424-3 are applicable to other electrodes depicted in FIG. 42B as well. FIG. 8A As FIG. 8B As depicted in FIG. 42B, 16 electrodes can be provided on the flexible frame.

[0194] In some embodiments, the spacing between each of the horizontally spaced electrodes can be equal. As used herein, the terms “horizontally spaced” and “horizontal spacing” can be used interchangeably with the terms “laterally spaced” and “lateral spacing,” respectively. For example, the spacing between electrodes 424-1, 424-3 can be equal to the spacing between other horizontally spaced electrodes provided on flexible frame 420. In some embodiments, the spacing between each of the horizontally spaced electrodes (e.g., electrodes 424-1, 424-3) can 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) can be 4 millimeters.

[0195] In some embodiments, the spacing between each of the vertically spaced electrodes can be equal. As used herein, the terms “vertically spaced” and “vertical spacing” can be used interchangeably with the terms “longitudinally spaced” and “longitudinal spacing,” respectively. For example, the spacing between electrodes 424-1, 424-2 can be equal to the spacing between other vertically spaced electrodes provided on flexible frame 420. In some embodiments, the spacing between each of the vertically spaced electrodes (e.g., electrodes 424-1, 424-2) can 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) can be 4 millimeters.

[0196] As FIG. 8BThe flexible frame 426, as depicted in FIG. 4B, is formed of a plurality of arms 428-1, 428-2, 428-3, 428-4, 428-5 (including a first outer arm 428-1, a first inner arm 428-2, a center arm 428-3, a second inner arm 428-4, and a second outer arm 428-5). A plurality of electrodes 430-1, 430-2, 430-3, 430-4, 430-5, 430-6, 430-7, 430-8, 430-9, 430-10, 430-11 are disposed on the flexible frame 426. In some embodiments, a greater density of electrodes can be disposed on the first inner arm 428-2, the center arm 428-3, and the second inner arm 428-4. For ease of reference, only electrodes 424-1, 424-2, 424-3, 424-4, 424-5, 424-6, 424-7, 424-8, 424-9 are referenced herein, however, the principles discussed with respect to electrodes 424-1, 424-2, 424-3, 424-4, 424-5, 424-6, 424-7, 424-8, 424-9 apply to the other electrodes depicted in FIG. 4B as well. FIG. 8B As depicted in FIG. 4B, a greater density of electrodes can be disposed on the first inner arm 428-2, the center arm 428-3, and the second inner arm 428-4. FIG. 8C As depicted in FIG. 4B, a greater density of electrodes can be disposed on the first inner arm 428-2, the center arm 428-3, and the second inner arm 428-4.

[0197] 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 can be equal. In some embodiments, the spacing between each of the horizontally spaced electrodes (e.g., 424-1, 424-3) can be in a range of 2 to 5 millimeters. In some embodiments, the spacing between each of the horizontally spaced electrodes (e.g., 424-1, 424-3) can be 4 millimeters.

[0198] In some embodiments, the spacing between each of the vertically spaced electrodes (e.g., electrodes 430-1, 430-8) on the first and second lateral arms 428-1, 428-5 can be equal. In some embodiments, the spacing between each of the vertically spaced electrodes (e.g., electrodes 430-1, 430-8) on the first and second lateral arms 428-1, 428-5 can remain the same as the spacing between the particular electrodes (e.g., electrodes 430-2, 430-9) disposed on the first medial arm 428-2, the central arm 428-3, and the second medial arm 428-4, despite the higher density of electrodes disposed on the first medial arm 428-2, the central arm 428-3, and the second medial arm 428-4. For example, the spacing between the electrodes 430-2, 430-9 disposed on the second medial arm 428-4 can be equal to the spacing between the electrodes 430-1, 430-8 disposed on the second lateral 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.

[0199] In some embodiments, the spacing between the electrodes (e.g., electrodes 430-2, 430-3, 430-6, 430-7) disposed on the first medial arm 428-2, the central arm 428-3, and the second medial arm 428-4 can include a smaller spacing between the electrodes (e.g., electrodes 430-1, 430-8) disposed on the first and second lateral arms 428-1, 428-5, thereby resulting in a greater density of electrodes disposed on the first medial arm 428-2, the central arm 428-3, and the second medial arm 428-3. In some embodiments, the greater density of electrodes disposed on the first medial arm 428-2, the central arm 428-3, and the second medial arm 428-3 can form a flexible frame 426 that can provide a greater sensing granularity. In some embodiments using the electrodes for ablation, the greater density of electrodes disposed on the first medial arm 428-2, the central arm 428-3, and the second medial arm 428-3 can provide a more intensive ablation pattern.

[0200] 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 medial arm 428-2, the central arm 428-3, and the second medial arm 428-3 can be in a range of 1 to 3 millimeters. 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 millimeters. 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 medial arm 428-2, the central arm 428-3, and the second medial arm 428-4 can be in a range of 1 to 3 millimeters. 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 millimeters.

[0201] 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) can be disposed on the first lateral arm 428-1 and the second lateral arm 428-5, the first medial arm 428-2 and the second medial arm 428-4, and the central arm 432, and can have equal spacing between the electrodes. In an example, the spacing between each of the electrodes 430-1, 430-2, 430-4, 430-5, 430-8, 430-9, 430-10, 430-11 can be a first dimension (e.g., 2 millimeters). In some embodiments, a second plurality of electrodes (e.g., electrodes 430-2, 430-3, 430-6, 430-7) can be disposed on the first medial arm 428-2 and the second medial arm 428-4, and the central arm 428-3, and can have equal spacing between the electrodes. In an example, the spacing between each of the electrodes 430-2, 430-3, 430-6, 430-7 can be a second dimension (e.g., 1 millimeter). In some embodiments, the second dimension can be less than the first dimension, thus resulting in a greater density of electrodes disposed on the first medial arm 428-2 and the second medial arm 428-4, and the central arm 428-3.

[0202] As further depicted, the flexible frame 426 can include a magnetic position sensor 432 disposed on a distal portion of the center arm 428-3. In some embodiments, the position of the magnetic position sensor 432 can be determined, and thus the position of the distal portion of the flexible frame 426 can be determined. The magnetic position sensor 432 can 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 center arm 428-3, the magnetic position sensor 432 can 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 can include more than one magnetic position sensor. In some embodiments, as previously discussed herein, the magnetic position sensor 432 can be disposed in a magnetic position sensor mount that also serves as an additional electrode. Thus, in some embodiments, the flexible frame 426 can include 30 electrodes.

[0203] As FIG. 8C depicted in FIG. 44, a flexible frame 438 formed of a plurality of arms 440-1, 440-2, 440-3, 440-4, 440-5 (including a first outer arm 440-1, a first inner arm 440-2, a center arm 440-3, a second inner arm 440-4, and a second outer arm 440-5) can have a plurality of electrodes 442-1, 442-2, 442-3 disposed thereon. In some embodiments, the plurality of arms 440-1, 440-2, 440-3, 440-4, 440-5 can include electrodes 442-1, 442-2, 442-3 of equal density. For ease of reference, only electrodes 442-1, 442-2, 442-3 are referenced herein, however, the principles discussed with respect to electrodes 440-1, 440-2, 440-3 apply to the other electrodes depicted in FIG. 44 as well. FIG. 8C As FIG. 8D depicted in FIG. 44, a flexible frame 438 formed of a plurality of arms 440-1, 440-2, 440-3, 440-4, 440-5 (including a first outer arm 440-1, a first inner arm 440-2, a center arm 440-3, a second inner arm 440-4, and a second outer arm 440-5) can have a plurality of electrodes 442-1, 442-2, 442-3 disposed thereon. In some embodiments, the plurality of arms 440-1, 440-2, 440-3, 440-4, 440-5 can include electrodes 442-1, 442-2, 442-3 of equal density. For ease of reference, only electrodes 442-1, 442-2, 442-3 are referenced herein, however, the principles discussed with respect to electrodes 440-1, 440-2, 440-3 apply to the other electrodes depicted in FIG. 44 as well.

[0204] In some embodiments, the spacing between each of the horizontally spaced electrodes can be equal. For example, the spacing between electrodes 442-1, 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, 442-3) can be in the range of 2 to 4 millimeters. In some embodiments, the spacing between each of the horizontally spaced electrodes (e.g., electrodes 442-1, 442-3) can be 3 millimeters. In some embodiments, the spacing between each of the vertically spaced electrodes can be equal. For example, the spacing between electrodes 442-1, 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, 442-2) can be in the range of 2 to 4 millimeters. In some embodiments, the spacing between each of the vertically spaced electrodes (e.g., electrodes 442-1, 442-2) can be 3 millimeters.

[0205] As further depicted, the flexible frame 438 can include a magnetic position sensor 444 disposed on the distal portion of the center arm 440-3. In some embodiments, the magnetic position sensor 444 can be used to determine the position and orientation of the distal portion of the flexible frame. The magnetic position sensor 444 can 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 444 can be disposed in a magnetic position sensor mount that also functions as an additional electrode. Thus, in some embodiments, the flexible frame 438 can include 30 electrodes.

[0206] As FIG. 8D depicted in FIG. 45, the flexible frame 450 formed by the plurality of arms 452-1, 452-2,..., 422-6 (including the first lateral arm 452-1, the first medial arm 452-2, the first medial arm 452-3, the second lateral arm 452-4, the second medial arm 452-5, the second lateral arm 452-6) can have a plurality of electrodes 454-1, 454-2, 454-3 disposed thereon. For ease of reference, only electrodes 454-1, 454-2, 454-3 are referenced herein, however, the principles discussed with respect to electrodes 454-1, 454-2, 454-3 are applicable to the other electrodes depicted in FIG. 45 as well. FIG. 8D As FIG. 8E depicted in FIG. 45, the flexible frame 450 can have 36 electrodes disposed thereon.

[0207] In some embodiments, the spacing between each of the horizontally spaced electrodes can be equal. For example, the spacing between electrodes 454-1, 454-3 can 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, 454-3) can be in the range of 1.4 to 3.4 millimeters. In some embodiments, the spacing between each of the horizontally spaced electrodes (e.g., electrodes 454-1, 454-3) can be 2.4 millimeters.

[0208] In some embodiments, the spacing between each of the vertically spaced electrodes can be equal. For example, the spacing between electrodes 454-1, 454-2 can 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, 454-2) can be in the range of 1.4 to 3.4 millimeters. In some embodiments, the spacing between each of the vertically spaced electrodes (e.g., electrodes 454-1, 454-2) can be 2.4 millimeters.

[0209] As FIG. 8E depicted in FIG. 46A, a plurality of electrodes 462-1, 462-2, 462-3 are disposed on the flexible frame 460 formed by a plurality of arms 462-1, 462-2, 462-3, 462-4, 462-5, 462-6, 462-7 (including a first outer arm 462-1, a first middle arm 462-3, a first inner arm 463-3, a center arm 462-4, a second inner arm 462-5, a second middle arm 462-6, and a second outer arm 462-7). For ease of reference, only electrodes 462-1, 462-2, 462-3 are referenced herein, however, the principles discussed with respect to electrodes 462-1, 462-2, 462-3 also apply to other electrodes depicted in FIG. 46A. FIG. 8E As FIG. 9 depicted in FIG. 46A, a plurality of electrodes 462-1, 462-2, 462-3 are disposed on the flexible frame 460 formed by a plurality of arms 462-1, 462-2, 462-3, 462-4, 462-5, 462-6, 462-7 (including a first outer arm 462-1, a first middle arm 462-3, a first inner arm 463-3, a center arm 462-4, a second inner arm 462-5, a second middle arm 462-6, and a second outer arm 462-7). For ease of reference, only electrodes 462-1, 462-2, 462-3 are referenced herein, however, the principles discussed with respect to electrodes 462-1, 462-2, 462-3 also apply to other electrodes depicted in FIG. 46A.

[0210] In some embodiments, the spacing between each of the horizontally spaced electrodes can be equal. For example, the spacing between electrodes 464-1, 464-3 can be equal to the spacing between other horizontally spaced electrodes disposed on flexible frame 460. In some embodiments, the spacing between each of the horizontally spaced electrodes (e.g., electrodes 464-1, 464-3) can be in a range of 1 to 3 millimeters. In some embodiments, the spacing between each of the horizontally spaced electrodes (e.g., electrodes 464-1, 464-3) can be 2 millimeters. In some embodiments, the spacing between each of the vertically spaced electrodes can be equal. For example, the spacing between electrodes 464-1, 464-2 can be equal to the spacing between other vertically spaced electrodes disposed on flexible frame 460. In some embodiments, the spacing between each of the vertically spaced electrodes (e.g., electrodes 464-1, 464-2) can be in a range of 0.5 to 3 millimeters. In some embodiments, the spacing between each of the vertically spaced electrodes (e.g., electrodes 464-1, 464-2) can be 2 millimeters.

[0211] As further depicted, flexible frame 460 can include a magnetic position sensor 466 disposed on a distal portion of central arm 462-4. In some embodiments, magnetic position sensor 466 can be used to determine the position and orientation of the distal portion of the flexible frame. Magnetic position sensor 466 can be a five degree of freedom sensor and / or a six degree of freedom sensor. In some embodiments, as previously discussed herein, magnetic position sensor 466 can be disposed in a magnetic position sensor mount that also functions as an additional electrode. Thus, in some embodiments, flexible frame 438 can include 50 electrodes.

[0212] FIG. 9 is an isometric back view of a distal tip assembly 480 including a magnetic position sensor mount 486 and a distal coupling 482 according to embodiments of the present disclosure. As depicted, distal coupling 482 can define one or more lateral lumens 484-1, 484-2 extending therethrough, as discussed herein. One or more arms (not depicted) associated with the flexible frame can be disposed through the one or more lateral lumens 484-1, 484-2. In some embodiments, magnetic position sensor mount 486 can extend proximally from distal coupling 482. In some embodiments, magnetic position sensor mount 486 can include a first sensor groove 488-1 and a second sensor groove 488-2 defined in an outer surface 490 of magnetic position sensor mount 486 FIG. 10). In some embodiments, the first sensor recess 488-1 and the second sensor recess 488-2 can be angled relative to each other and / or relative to a 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 the magnetic position sensors disposed therein, as further depicted in U.S. Patent Application No. 15 / 585,859, can include those features discussed with respect to the magnetic position sensor mount 486. FIG. 3A The magnetic position sensors disposed in the first sensor recess 488-1 and the second sensor recess 488-2, as further depicted in U.S. Patent Application No. 15 / 585,859, can include those features discussed with respect to U.S. Patent Application No. 15 / 585,859, which is hereby incorporated by reference as if fully set forth herein.

[0213] 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 can allow for determination of roll of the magnetic position sensor mount 486 and the associated distal coupling 482, and thus the flexible frame connected to the distal coupling 482 and / or the magnetic position sensor mount 486.

[0214] Although the magnetic position sensor mount 486 is shown as being connected to the distal coupling 482, the magnetic position sensor mount 486 can be disposed along other portions of the flexible frame of the high-density electrode catheter, as discussed herein. For example, the magnetic position sensor mount 486 and associated magnetic position sensors can be disposed along the center arm, the medial arm, the intermediate arm, and / or the lateral arm, as discussed herein.

[0215] As further discussed herein, in some embodiments, the magnetic position sensor mount 486 can form an electrode. In some embodiments, an electrically conductive material, not depicted, can surround the magnetic position sensor mount 486, which can form an electrode. For example, the center electrode 130 (e.g., with respect to at least FIG. 10 the center electrode 130 depicted and discussed herein) can be disposed over the magnetic position sensor mount 486.

[0216] FIG. 9is a side view of a distal tip assembly 500 including a magnetic position sensor mount 506 and a distal coupling 502 according to embodiments of the present disclosure. As depicted, the distal coupling 502 can define one or more lateral lumens 504-1, 504-2 extending therethrough, as discussed herein. One or more arms (not depicted) associated with the flexible frame can be disposed through the one or more lateral lumens 504-1, 504-2. In some embodiments, the magnetic position sensor mount 506 can extend proximally from the distal coupling 502. In some embodiments, the magnetic position sensor mount 506 can include a first sensor groove 508-1 and a second sensor groove 508-2 defined in an outer surface 510 of the magnetic position sensor mount 506 FIG. 10 ). In some embodiments, the first sensor groove 508-1 and the second sensor groove 508-2 can be angled relative to one another and / or relative to a longitudinal axis of the magnetic position sensor mount 506. In some embodiments, the first sensor groove 508-1 and the second sensor groove 508-2 and the magnetic position sensors 512-1, 512-2 disposed therein (magnetic position sensor 512-2 hidden from view) can include those features discussed with respect to U.S. Patent Application No. 15 / 585,859, which is hereby incorporated by reference as if fully set forth herein.

[0217] For example, in some embodiments, when the magnetic position sensors 512-1, 512-2 are disposed in the first sensor groove 508-1 and the second sensor groove 508-2, the magnetic position sensors 512-1, 512-2 can be tilted relative to one another. This can allow for determination of roll of the magnetic position sensor mount 506 and associated distal coupling 502, and thus the flexible frame connected to the distal coupling 502 and / or the magnetic position sensor mount 506.

[0218] Although the magnetic position sensor mount 506 is shown as connected to the distal coupling 502, the magnetic position sensor mount 506 can be disposed along other portions of the flexible frame of the high-density electrode catheter, as discussed herein. For example, the magnetic position sensor mount 506 and associated magnetic position sensors can be disposed along a central arm, an inner side arm, a middle arm, and / or an outer side arm, as discussed herein.

[0219] As FIG. 1A depicted in FIG. 6, the first twisted pair 514-1 and the second twisted pair 514-2 can electrically couple the magnetic position sensors 512-1, 512-2 to FIG. 1B and FIG. 10one or more of the computer systems 20, 64 depicted in FIG. 1. As further depicted in FIG. 1, the magnetic position sensor assembly 506 is coupled to the distal end of the flexible frame 516. In some embodiments, the magnetic position sensor assembly 506 can be coupled to the distal end of the flexible frame 516 via a distal coupling 508, as discussed herein, for example, with respect to FIG. 2. FIG. 3J As further depicted in FIG. 1, the electrode wires 518 are shown extending from the proximal end of the magnetic position sensor mount 506, which can be electrically coupled with electrodes disposed on the magnetic position sensor mount and one or more of the computer systems 20, 64. Also shown is that the central frame 516 of the flexible frame also extends from the proximal end of the magnetic position sensor mount, as discussed herein. In some embodiments, the central frame 516 can be coupled to the proximal end of the magnetic position sensor mount 506, as discussed herein, for example, with respect to FIG. 2. FIG. 3S and FIG. 11 as discussed herein.

[0220] FIG. 11 is a top view of a high-density electrode catheter 530 having staggered electrodes 534-1, 534-2, …, 534-25 in accordance with embodiments of the present disclosure. As depicted, the high-density electrode catheter 530 can include a flexible frame formed by a first lateral arm 532-1, a first medial arm 532-2, a central arm 532-3, a second medial arm 532-4, and a second lateral arm 532-5. In some embodiments, the proximal ends of the arms 532-1, 532-2, … 532-5 can be disposed in a proximal coupling 536, which can be mounted on a distal end of a catheter shaft (not depicted), as discussed herein. The distal ends of the arms 532-1, 532-2, …, 532-5 can be mounted with a distal coupling 538. However, in some embodiments, the arms 532-1, 532-2, …, 532-5 can not be coupled to one another.

[0221] As depicted, the central arm 532-3 can include an elongated feature 540, as discussed herein. In some embodiments, the central arm 532-3 can include an electrode 542 disposed at the distal end of the central arm 532-3. In some embodiments, the core of the electrode 542 can include a magnetic position sensor (not depicted) that can be used to determine the position and / or orientation of the flexible frame 531.

[0222] In some embodiments, as depicted, each of the arms 532-1, 532-2, …, 532-5 can include electrodes 534-1, 534-2, …, 534-25 disposed thereon. As depicted, the electrodes on each of the arms 532-1, 532-2, …, 532-5 can be staggered relative to one another. For example, the electrodes 534-1, 534-2, …, 534-5 on the first lateral arm 532-1 can be staggered relative to the electrodes 534-6, 534-7, …, 534-10 disposed on the first medial arm 532-2. As depicted, the electrodes 534 disposed on each arm can be staggered relative to the electrodes 534 disposed on each adjacent arm.

[0223] In some embodiments, the electrodes 534 disposed on the first medial arm 532-2 and the electrodes 534 disposed on the first lateral arm 532-1 and the central arm 532-3 can form a cluster (e.g., group) of electrodes 534; the electrodes 534 disposed on the central arm 532-3 and the electrodes 534 disposed on the first medial arm 532-2 and the second medial arm 532-4 can form a cluster of electrodes 534; and / or the electrodes 534 disposed on the second medial arm 532-4 and the electrodes 534 disposed on the central arm 532-3 and the second lateral arm 532-5 can form a cluster of electrodes 534. For example, with respect to the first lateral arm 532-1, the first medial arm 532-2, and the central arm 532-3, the cluster of electrodes 534-1, 534-6, 534-7, 534-11 is represented by parallelogram 544.

[0224] In some embodiments, staggering the electrodes 534-1, 534-2, …, 534-25 disposed on each of the arms 532-1, 532-2, …, 532-5 can be advantageous because it provides a tradeoff 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 an example, the spacing between each of the electrodes in the cluster of electrodes 534-1, 534-6, 534-7, 534-11 can be the same. For example, the spacing between electrodes 534-1 and 534-7 can be the same as the spacing between electrodes 534-1 and 534-6, which can be the same as the spacing between electrodes 534-6 and 534-7. With respect to the first lateral arm 532-1, the first medial arm 532-2, and the central arm 532-3, the spacing between electrodes 534-1 and 534-6 can be the same as the spacing between electrodes 534-6 and 534-7, which can be the same as the spacing between electrodes 534-7 and 534-11. FIG. 11 The depicted and discussed embodiments can allow for a reduction in the spacing between electrodes 534 while using the same number of electrodes as embodiments in which the electrodes 534-1, 534-2, …, 534-25 are not staggered. In some embodiments in which the electrodes, although not staggered, are aligned with one another along the cross-axial axis of the flexible tip portion, a greater number of electrodes and / or a greater number of arms can be required to have the same spacing between a group of staggered electrodes, for example, with respect to the first lateral arm 532-1, the first medial arm 532-2, and the central arm 532-3, the spacing between electrodes 534-1 and 534-6 can be the same as the spacing between electrodes 534-6 and 534-7, which can be the same as the spacing between electrodes 534-7 and 534-11. FIG. 12A The depicted spacing.

[0225] FIG. 12A is a top view of a lower structure 548 of a flexible tip of a high-density electrode catheter in accordance with embodiments of the present disclosure including magnetic position sensors 554-1, 554-2 located in lateral frames. As depicted, the lower structure 548 can include a first lateral frame 550-1 and a second lateral frame 550-2. In some embodiments, the first lateral frame 550-1 and the second lateral frame 550-2 can be substantially parallel to one another. In some embodiments, the first lateral frame 550-1 and the second lateral frame 550-2 can be substantially perpendicular to one another. FIG. 12A A portion of the entire lower structure associated with a flexible tip of a high-density electrode catheter is depicted. For example, FIG. 12AAn outer-lower-structure portion of the entire lower structure is depicted, which can also include a medial frame and / or an inner frame, as discussed further herein. For example, the lower structure to which the first outer-lateral frame 550-1 and the second outer-lateral frame 550-2 belong can have a total of two arms to eight arms, however in some embodiments embodiments of the present disclosure can include more than eight arms. As depicted, the first frame 550-1 and the second frame 550-2 can include a frame mounting portion 552-1, 552-2.

[0226] In some embodiments, the magnetic position sensors 554-1, 554-2 can be disposed along the first outer-lateral frame 550-1 and the second outer-lateral frame 550-2, as FIG. 12A depicted in FIG. 6. In some embodiments, the magnetic position sensors 554-1, 554-2 can be disposed along a top, a bottom, an interior, and / or an exterior of each of the first outer-lateral frame 550-1 and the second outer-lateral frame 550-2. In some embodiments, the first outer-lateral frame 550-1 and the second outer-lateral frame 550-2 can include mounting features that can be configured to allow for the mounting of the magnetic position sensors 554-1, 554-2 along the first outer-lateral frame 550-1 and the second outer-lateral frame 550-2.

[0227] In some embodiments, as depicted, the first outer-lateral frame 550-1 and the second outer-lateral frame 550-2 can include a slot 556-1, 556-2 defined along a longitudinal extension of the first outer-lateral frame 550-1 and the second outer-lateral frame 550-2. As depicted, in some embodiments, the slot 556-1, 556-2 defines a central mounting space that extends longitudinally along the first outer-lateral frame 550-1 and the second outer-lateral frame 550-2. As depicted, the slot 556-1, 556-2 and the associated magnetic position sensor 554-1, 554-2 are shown positioned proximal to a shoulder portion 558-1, 558-2. In some embodiments, the magnetic position sensor 554-1, 554-2 can be positioned along other portions of the first outer-lateral frame 550-1 and the second outer-lateral frame 550-2. For example, the magnetic position sensor 554-1, 554-2 can be positioned proximally along the position in which it is depicted in FIG. 6 from the FIG. 12B In some embodiments, the magnetic position sensor 554-1, 554-2 can be located in a proximal tip portion 560 of the outer-lateral lower structure. Although two magnetic position sensors 554-1, 554-2 are shown disposed along the outer-lateral frame 550-1, 550-2, fewer than or more than two magnetic position sensors 554-1, 554-2 can be disposed along the outer-lateral frame 550-1, 550-2.

[0228] In some embodiments, as discussed, the slots 556-1, 556-2 can be defined in a portion of the first and second lateral frames 550-1, 550-2. In the case of the second slot 556-2, the second slot 556-2 can be defined along the second lateral 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 lateral frame 550-2 can be cuttable such that the slot 556-2 is defined, leaving the first and second slot frames 562-1, 562-2. In some embodiments, the portion of the lateral frame 550-2 that defines the slot 556-2 can be widened such that the combined lateral width of each slot frame 562-1, 562-2 can match the lateral width of the lateral frame 550-2 when material is removed from the lateral frame 550-2 to define the slot 556-2. As can be seen, this portion of the lateral frame 550-2 includes a flare 564 such that the portion of the lateral frame 550-2 that includes the magnetic position sensor 554-2 is wider than other longitudinally extending portions of the lateral frame 550-2. In some embodiments, the total lateral width of the slot frames 562-1, 562-2 can be less than or greater than the lateral width of other longitudinally extending portions of the lateral frame 550-2, e.g., the longitudinally extending portions of the lateral frame 550-2 positioned proximal to the slot frames 562-1, 562-2. Thus, even though the slot 556-2 is defined in the lateral frame 550-2, the flexibility of the portion of the lateral frame 550-2 that includes the magnetic position sensor can match or closely match the flexibility of other longitudinally extending portions of the lateral frame 550-2, e.g., those positioned proximal to the magnetic position sensor 554-2. Although the above discussion is directed to the second lateral frame 550-2, this can be true for the other frames as well.

[0229] As depicted, the magnetic position sensor 554-2 can be positioned between the slot frames 562-1, 562-2. In some embodiments, the top and bottom surfaces of the magnetic position sensor can be flush with the top and bottom surfaces of the lateral frame 550-2. In some embodiments, the top and bottom surfaces of the magnetic position sensor 554-2 can protrude above or recess below the top and / or bottom surfaces of the lateral frame 550-2.

[0230] In some embodiments, the slots 556-1, 556-2 can be defined via laser cutting. For example, in some embodiments, the lower structure 548 can be defined by laser cutting, including the slots 556-1, 556-2. In some embodiments, the lower structure 548 can be produced via a mold, including the slots 556-1, 556-2. In some embodiments, the lower structure 548 and the slots 556-1, 556-2 can be produced by two different processes. For example, the lower structure 548 can be molded, while the slots 556-1, 556-2 can be defined by a laser. In some embodiments, the slots 556-1, 556-2 and the lower structure 548 can each be formed by the same process.

[0231] FIG. 12A is a close-up view of a lower structure of a flexible tip of a high-density electrode catheter according to embodiments of the present disclosure FIG. 12B is a close-up view of a lower structure of a flexible tip of a high-density electrode catheter depicted in FIG. 5B, with further depiction of a magnetic position sensor 554-2 in the outer frame 550-2. In some embodiments, the outer frame 550-2 can define a slot 556-2, which is defined by slot frames 562-1, 562-2. As depicted, the magnetic position sensor 554-2 can be disposed between the slot frames 562-1, 562-2. In some embodiments, a channel can be defined in the outer frame 550-2. For example, as depicted in FIG. 5B, a through slot is defined in the outer frame 550-2, however, in some embodiments, a channel can be defined, which can include a recessed area defined in the outer frame 550-2. For example, the outer frame 550-2 can be recessed such that a channel is defined in a surface of the outer frame 550-2, thereby creating a pocket for the magnetic position sensor. Accordingly, the magnetic position sensor 554-2 can be disposed in the channel such that the magnetic position sensor 554-2 contacts a bottom of the channel, thereby facilitating placement of the magnetic position sensor 554-2. FIG. 13A

[0232] FIG. 13A is a top view of a lower structure 570 of a flexible tip of a high-density electrode catheter according to embodiments of the present disclosure, including magnetic position sensors 576-1, 576-2 located in outer frames. As depicted, the lower structure 570 can include a first outer frame 572-1 and a second outer frame 572-2. In some embodiments, the first outer frame 572-1 can define a slot 556-1, and the second outer frame 572-2 can define a slot 556-2. In some embodiments, the slots 556-1, 556-2 can be defined via laser cutting. For example, in some embodiments, the lower structure 570 can be defined by laser cutting, including the slots 556-1, 556-2. In some embodiments, the lower structure 570 can be produced via a mold, including the slots 556-1, 556-2. In some embodiments, the lower structure 570 and the slots 556-1, 556-2 can be produced by two different processes. For example, the lower structure 570 can be molded, while the slots 556-1, 556-2 can be defined by a laser. In some embodiments, the slots 556-1, 556-2 and the lower structure 570 can each be formed by the same process. FIG. 13A depicts a portion of an entire lower structure associated with a flexible tip of a high-density electrode catheter. For example, FIG. 13A ​An outer-lateral understructure portion of the entire understructure is depicted, which entire understructure can also include a medial frame and / or an inner-lateral frame, as discussed further herein. For example, the understructure to which the first and second outer-lateral frames 572-1, 572-2 belong can have a total of two arms to eight arms, however embodiments of the present disclosure can include more than eight arms in some embodiments. As depicted, the first and second frames 572-1, 572-2 can include frame mounting portions 574-1, 574-2.

[0233] In some embodiments, the magnetic position sensors 576-1, 576-2 can be disposed along the first and second outer-lateral frames 572-1, 572-2, as FIG. 13A depicted in FIG. 5B. In some embodiments, the magnetic position sensors 576-1, 576-2 can be disposed along a top, a bottom, an interior, and / or an exterior of each of the first and second outer-lateral frames 572-1, 572-2. In some embodiments, the first and second outer-lateral frames 572-1, 572-2 can include mounting features that can be configured to allow the magnetic position sensors 576-1, 576-2 to be mounted along the first and second outer-lateral frames 572-1, 572-2.

[0234] In some embodiments, as depicted, the first and second outer-lateral frames 572-1, 572-2 can include cutouts 578-1, 578-2 defined along a longitudinal extent of the first and second outer-lateral frames 572-1, 572-2. As depicted, in some embodiments, the cutouts 578-1, 578-2 define mounting spaces that extend longitudinally along an interior of the first and second outer-lateral frames 572-1, 572-2. As depicted, the cutouts 578-1, 578-2 and associated magnetic position sensors 576-1, 576-2 are shown positioned proximal to shoulder portions 580-1, 580-2. In some embodiments, the magnetic position sensors 576-1, 576-2 can be positioned along other portions of the first and second outer-lateral frames 572-1, 572-2. For example, the magnetic position sensors 576-1, 576-2 can be positioned proximally along the locations in which they are depicted in FIG. 5B. In some embodiments, the magnetic position sensors 576-1, 576-2 can be located in a distal tip portion 582 of the outer-lateral understructure. Although two magnetic position sensors 576-1, 576-2 are shown disposed along the outer-lateral frames 572-1, 572-2, fewer than or more than two magnetic position sensors 576-1, 576-2 can be disposed along the outer-lateral frames. FIG. 13A

[0235] ​In some embodiments, as discussed, the cutouts 578-1, 578-2 can be defined in a portion of the first and second lateral frames 572-1, 572-2. With respect to the second cutout 578-2, the cutout can be defined along an interior edge of the second lateral frame 572-2. In some embodiments, although not depicted, the cutout 578-2 can be defined along an exterior edge of the second lateral frame 572-2.

[0236] In some embodiments, the second lateral frame 572-2 can be cut such that the cutout 578-2 is defined. In some embodiments, the portion of the lateral frame 572-2 that defines the cutout 578-2 can be widened such that the lateral width of the cutout frame 584 can match the lateral width of the lateral frame 572-2 when material is removed from the lateral frame 572-2 to define the cutout 578-2. As can be seen, this portion of the lateral frame 572-2 includes a flare 586 such that the portion of the lateral frame 572-2 that includes the magnetic position sensor 576-2 is wider than other longitudinally extending portions of the lateral frame 572-2. In some embodiments, the overall lateral width of the cutout frame 584 can be less than or greater than the lateral width of other longitudinally extending portions of the lateral frame 572-2, e.g., longitudinally extending portions of the lateral frame 572-2 positioned proximal the cutout frame 584. Thus, even though the cutout 578-2 is defined in the lateral frame 572-2, the flexibility of the portion of the lateral frame 572-2 that includes the magnetic position sensor can match or closely match the flexibility of other longitudinally extending portions of the lateral frame 572-2, e.g., those positioned proximal the magnetic position sensor 576-2. Although the discussion above is directed to the second lateral frame 572-2, this can be true for other frames as well.

[0237] In some embodiments, the top and bottom surfaces of the magnetic position sensor 576-2 can be flush with the top and bottom surfaces of the lateral frame 572-2. In some embodiments, the top and bottom surfaces of the magnetic position sensor 576-2 can protrude above or be recessed below the top and bottom surfaces of the lateral frame 572-2.

[0238] In some embodiments, the cutouts 578-1, 578-2 can be defined via laser cutting. For example, in some embodiments, the underlying structure 570 can be defined by laser cutting, including the cutouts 578-1, 578-2. In some embodiments, the underlying structure 570 can be produced via a mold, including the cutouts 578-1, 578-2. In some embodiments, the underlying structure 570 and the cutouts 578-1, 578-1 can be produced by two different processes. For example, the underlying structure 570 can be molded, while the cutouts 578-1, 578-2 can be defined by a laser. In some embodiments, the cutouts 578-1, 578-2 and the underlying structure 570 can each be defined by the same process.

[0239] 13B is a close-up view of a portion of the underlying structure of the flexible tip of a high-density electrode catheter depicted in FIG. 13A, further depicting a magnetic position sensor 576-2 in the outboard frame 572-2. In some embodiments, the outboard frame 572-2 can define a cutout 578-2, the cutout 578-2 defined by a cutout arm 584. As depicted, the magnetic position sensor 576-2 can be disposed inside the cutout arm 584. In some embodiments, the magnetic position sensor 576-2 can be disposed outside the cutout arm 584. FIG. 14

[0240] FIGS. 12A-13B is a top view of a high-density electrode catheter 600 according to embodiments of the present disclosure, magnetic position sensors 602-1, 602-2 disposed in outboard arms 604-1, 604-5 of the high-density electrode catheter 600. As depicted, the high-density electrode catheter 600 can include a proximal coupling 606, longitudinal extension arms 604-1, 604-2, …, 604-5 coupled to the proximal coupling 606, as discussed herein. In some embodiments, one or more electrodes 608 can be disposed along one or more of the arms. In some embodiments, the high-density electrode catheter 600 can include more or fewer than five arms 604-1, 604-2, …, 604-5.

[0241] In some embodiments, the high-density electrode catheter 600 can include a magnetic position sensor disposed along one or more of the longitudinal extension arms 604-1, 604-2, …, 604-5. As depicted, a first magnetic position sensor 602-1 and a second magnetic position sensor 602-2 can be disposed along a portion of the first outboard arm 604-1 and the second outboard arm 604-5. In some embodiments, the frames associated with the first outboard arm 604-1 and the second outboard arm 604-5 can include features that are the same as or similar to the features discussed with respect to FIG. 12A

[0242] ​​As depicted, the frame associated with the first arm 604-1 and the second arm 604-5 can include a cutout in which the magnetic position sensor 602-1, 602-2 can be disposed, respectively. In some embodiments, the frame associated with the first arm 604-1 and the second arm 604-5 can include a slot, as discussed in FIG. 12B and ​ Although the first arm 604-1 and the second arm 604-2 are generally discussed herein, in some embodiments, magnetic position sensors can be disposed on other ones of the arms 604-2, 604-3, 604-4. While the magnetic position sensors 602-1, 602-2 are shown as being disposed on distal portions of the longitudinal extensions of the first arm 604-1 and the second arm 604-2, the magnetic position sensors 602-1, 602-2 can be disposed distally from the presently shown positions and / or proximally from the presently shown positions.

[0243] In some embodiments, the frame associated with the arms 604-1, 604-2, 604-5 can include materials such as nitinol, stainless steel, titanium, etc. In some embodiments, a tube can be disposed over the magnetic position sensors 602-1, 602-2 to help retain the magnetic position sensors so that they do not separate. In some embodiments, a tube can be disposed over the magnetic position sensors 602-1, 602-2, the magnetic position sensors 602-1, 602-2 being disposed within an outer tube over which the electrodes 608 are disposed. In some embodiments, the outer tube can be used to retain the magnetic position sensors 602-1, 602-2 without the use of an inner tube.

[0244] Embodiments of various devices, systems, and / or methods are described herein. Numerous specific details are set forth in order to provide a thorough understanding of the overall structure, function, manufacture, and use of the embodiments described in the specification and illustrated in the various drawings. It will be appreciated, however, that the embodiments can be practiced in

[0245] 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.

[0246] 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.

[0247] 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-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.

[0248] Any patent, publication, or other disclosure material (in whole or in part) herein incorporated by reference is only incorporated within the scope of the present disclosure to the extent that it provides existing definitions, statements, or other information concerning the present disclosure. Thus, and to the extent necessary, the disclosure as explicitly set forth herein supersedes any conflicting material incorporated herein by reference. Any material, or portion thereof, that is incorporated herein by reference but which conflicts with anything stated herein will only to the extent that it is incapable of being reconciled with the disclosure contained herein between that which is incorporated herein by reference and that which is expressly set forth herein.

Claims

1. A high-density electrode conduit, comprising: The catheter axis includes a proximal end and a distal end, and the catheter axis defines a longitudinal axis of the catheter axis; A magnetic position sensor is disposed along the distal portion of the conduit shaft; A flexible tip portion, positioned adjacent to the distal end of the catheter axis, wherein the flexible tip portion includes a flexible frame, the flexible frame comprising: A longitudinally extending first outer arm and a longitudinally extending second outer arm; The longitudinally extending first inner arm and the longitudinally extending second inner arm; and A central arm extending between the longitudinally extending first inner arm and the longitudinally extending second inner arm; A proximal coupling member, wherein a first outer arm, a second outer arm, a first inner arm, a second inner arm, and a central arm extend from the proximal coupling member, wherein the first outer arm and the second outer arm, as well as the first inner arm and the second inner arm, exit the proximal coupling member on a first plane, and the central arm exits the proximal coupling member on either side of the first plane and extends distally and passes through the first plane to a peak before extending toward the first plane; Multiple electrodes are disposed on the flexible frame; and A tip magnetic position sensor is disposed on the distal portion of the flexible frame.

2. The high-density electrode conduit according to claim 1, wherein: The distal portion of the flexible tip defines a lumen; and The tip magnetic position sensor is disposed inside the cavity.

3. The high-density electrode conduit according to claim 2, wherein, At least one of the longitudinally extending arms defines the lumen, and the tip magnetic position sensor is disposed in the lumen.

4. The high-density electrode conduit of claim 3, further comprising at least one electrode disposed in an arm extending longitudinally, wherein, The electrode defines the cavity in which the magnetic position sensor is disposed.

5. The high-density electrode conduit according to claim 1, wherein: The first outer arm, the second outer arm, the first inner wall, the second inner wall, and the central arm extend distally relative to the distal end of the catheter axis; and The tip magnetic position sensor is located at the distal end of the central arm.

6. The high-density electrode conduit according to claim 1, wherein: The central arm includes an electrode disposed at the distal end of the central arm; The electrode defines a longitudinally extending groove; and The tip magnetic position sensor is disposed within the longitudinally extending groove.

7. The high-density electrode conduit according to claim 1, further comprising: A distal coupling member is coupled to the first outer arm and the second outer arm, the first inner wall and the second inner wall, and the distal portion of the central arm; and The remote coupling includes the tip magnetic position sensor.

8. The high-density electrode conduit according to claim 7, wherein, The distal coupling defines a cavity in which the tip magnetic position sensor is disposed.

9. The high-density electrode conduit according to claim 7, wherein, The distal coupling defines a keyway, and the distal end of the central arm is disposed in the keyway.

10. The high-density electrode conduit according to claim 1, wherein: The tip magnetic position sensor includes a first magnetic position sensor and a second magnetic position sensor disposed on the first outer arm and the second outer arm.

11. A high-density electrode conduit, comprising: The catheter axis includes a proximal end and a distal end, and the catheter axis defines a longitudinal axis of the catheter axis; A magnetic position sensor is disposed along the distal portion of the conduit shaft; A flexible tip portion, positioned adjacent to the distal end of the catheter axis, wherein the flexible tip portion includes a flexible frame, the flexible frame comprising: A longitudinally extending first outer arm and a longitudinally extending second outer arm; The longitudinally extending first inner arm and the longitudinally extending second inner arm; and A central arm extending between the longitudinally extending first inner arm and the longitudinally extending second inner arm; A proximal coupling member, wherein a first outer arm, a second outer arm, a first inner arm, a second inner arm, and a central arm extend from the proximal coupling member, wherein the first outer arm and the second outer arm, as well as the first inner arm and the second inner arm, exit the proximal coupling member on a first plane, and the central arm exits the proximal coupling member on either side of the first plane and extends distally and passes through the first plane to a peak before extending toward the first plane; Multiple electrodes are disposed on each of the longitudinally extending first outer arm, the longitudinally extending second outer arm, and the central arm; and A tip magnetic position sensor is disposed on the distal portion of the central arm.

12. The high-density electrode conduit according to claim 11, wherein: The central arm includes a single longitudinally extending arm; and The central arm includes an extended feature portion.

13. The high-density electrode conduit according to claim 12, wherein: The extended feature includes a curved portion formed in the single longitudinal extension arm; and The extended feature is configured to elongate when the flexible tip portion is in a contracted state.

14. The high-density electrode conduit according to claim 12, wherein: The central arm includes a first longitudinally extending central arm and a second longitudinally extending central arm. The first longitudinally extending center arm and the second longitudinally extending center arm are separated from the proximal coupling member on either side of the first plane; and The proximal ends of the first inner sidewall and the second inner sidewall, the first outer arm and the second outer arm, and the first longitudinally extending central arm and the second longitudinally extending central arm each include a mounting portion.

15. The high-density electrode conduit according to claim 14, wherein, The mounting portion includes a clamp that secures it to the proximal coupling.

16. A high-density electrode conduit, comprising: The catheter axis includes a proximal end and a distal end, and the catheter axis defines a longitudinal axis of the catheter axis; A magnetic position sensor is disposed along the distal portion of the conduit shaft; A flexible tip portion, positioned adjacent to the distal end of the catheter axis, wherein the flexible tip portion includes a flexible frame, the flexible frame comprising: A longitudinally extending first outer arm and a longitudinally extending second outer arm; The longitudinally extending first inner arm and the longitudinally extending second inner arm; and A central arm extending between the longitudinally extending first inner arm and the longitudinally extending second inner arm; A proximal coupling member, wherein a first outer arm, a second outer arm, a first inner arm, a second inner arm, and a central arm extend from the proximal coupling member, wherein the first outer arm and the second outer arm, as well as the first inner arm and the second inner arm, exit the proximal coupling member on a first plane, and the central arm exits the proximal coupling member on either side of the first plane and extends distally and passes through the first plane to a peak before extending toward the first plane; A flexible circuit is disposed on the flexible frame, wherein the flexible circuit includes a plurality of electrodes disposed thereon; and A tip magnetic position sensor is disposed on the distal portion of the flexible frame.

17. The high-density electrode conduit according to claim 16, wherein: The flexible circuit is disposed on the top and bottom of the flexible frame; and The flexible circuit transitions from the outer surface of the flexible frame to the top and bottom surfaces of the flexible frame at the transition point.

18. The high-density electrode conduit according to claim 17, wherein, The flexible circuit extends distally from the transition point on the top and bottom surfaces of the flexible frame.

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