Modular steerable sheath and catheter

Abstract

To provide a modular catheter system.SOLUTION: A modular catheter system includes a guiding sheath and multiple catheter inserts configured to couple to the guiding sheath. The guiding sheath can include a navigation sensor coupled to a distal portion of a guiding sheath shaft. A location of the distal portion of each catheter insert can be determined on the basis of electrical signals from the navigation sensor. The catheter insert can be electrically coupled to the guiding sheath to provide electrical connection to an electrode assembly on the distal portion of each catheter insert. The guiding sheath may include a deflection mechanism that deflects the distal portion of the guiding sheath and a distal portion of a catheter shaft of the catheter insert. The modular catheter system may be configured to be tracked and moved without the catheter inserts requiring a navigation sensor or a deflection mechanism.SELECTED DRAWING: Figure 2

Description

[Technical field]

[0001] The present disclosure relates generally to medical devices, and more particularly to navigation and tracking of intraluminal devices, particularly catheters and guide sheaths. [Background technology]

[0002] Cardiac arrhythmias, such as atrial fibrillation (AF), occur when an area of ​​cardiac tissue abnormally conducts electrical signals to adjacent tissue. This disrupts the normal cardiac cycle and causes an asynchronous rhythm. By selectively ablating cardiac tissue by applying energy via a catheter, it is sometimes possible to stop or redirect the propagation of unwanted electrical signals from one part of the heart to another.

[0003] Many contemporary current ablation approaches utilize radiofrequency (RF) electrical energy to heat tissue. Irreversible electroporation (IRE) is an alternative approach to RF ablation. To achieve IRE, brief pulses of high-voltage electrical signals (pulsed-field ablation electrical signals) are delivered to tissue. The electrical signals produce irreversible permeabilization of cell membranes. Delivery of IRE energy to tissue using multi-electrode catheters has been previously proposed in the patent literature. Examples of systems and devices configured for IRE ablation are disclosed in U.S. Patent Application Publication Nos. 2021 / 0169550(A1), 2021 / 0169567(A1), 2021 / 0169568(A1), 2021 / 0161592(A1), 2021 / 0196372(A1), 2021 / 0177503(A1), and 2021 / 0186604(A1), each of which is incorporated by reference into this specification.

[0004] Regions of cardiac tissue can be mapped by catheters to identify abnormal electrical signals. Some catheter ablation procedures, particularly those involving persistent atrial fibrillation, may be performed using electrophysiology (EP) mapping to target regions of abnormal electrical signals. Such EP mapping may include the use of sensing electrodes configured to monitor electrical signals within the cardiovascular system to pinpoint the location of abnormal conductive tissue sites involved in the arrhythmia. An example of an EP mapping system is described in U.S. Pat. No. 5,738,096, which is incorporated herein by reference and attached in an appendix hereto. Examples of EP mapping catheters are described in U.S. Pat. No. 9,907,480, U.S. Patent Publication No. 2018 / 0036078, and U.S. Patent Publication No. 2018 / 0056038, each of which is incorporated herein by reference and attached in an appendix hereto.

[0005] In addition to using EP mapping, some catheter ablation procedures may be performed using an image guided surgery (IGS) system. An IGS system may allow a physician to visually track the position of the catheter within the patient in real time in conjunction with an image of the patient's anatomy. Some systems may provide a combination of EP mapping and IGS functionality, including the CARTO™ 3 system by Biosense Webster, Inc. (Irvine, California). An example of a catheter configured for use with an IGS system is disclosed in U.S. Pat. No. 9,480,416, which is incorporated herein by reference and attached in the appendix hereto.

[0006] Many catheter-based medical procedures utilize multiple catheters during a medical procedure. In such procedures, a guide sheath with a through lumen is positioned to provide intravenous access to a treatment site and is left in place while catheters and other intraluminal devices (e.g., dilators, transseptal needles, guidewires) are exchanged through the lumen of the guide sheath. For example, during a pulmonary vein isolation procedure, a guide sheath, a diagnostic catheter, and a therapeutic catheter may be utilized. Examples of such devices include, but are not limited to, the CARTO VIZIGO® bidirectional guide sheath, OCTARAY™ mapping catheter, and THERMOCOOL SMARTTOUCH® SF catheter by Biosense Webster, Inc. (Irvine, California). Summary of the Invention [Means for solving the problem]

[0007] The systems disclosed herein include a steerable catheter or guide sheath and a modular catheter insert that may be coupled to the steerable catheter or guide sheath (referred to herein as a guide sheath). The guide sheath includes a handle, which may include an electrical connector configured to couple to an electrical connector of the modular catheter insert, such that electrical signals measured at and / or delivered to the target area pass through the handle of the guide sheath. The guide sheath further includes a shaft having a lumen therethrough and may include a navigation sensor coupled to a distal portion of the shaft. The catheter insert may be configured to couple to the guide sheath such that a position of a distal portion of the catheter insert may be determined based on electrical signals from the navigation sensor on the distal portion of the guide sheath.

[0008] The system is configured such that the modular catheter inserts may be exchanged during a medical procedure. For example, a diagnostic catheter insert and an ablation diagnostic catheter insert may be exchanged during a medical procedure. During a medical procedure, the diagnostic catheter insert may be delivered to a target area through a guide sheath, and the diagnostic catheter may be coupled to the guide sheath. A position of an end effector of the diagnostic catheter may be determined based on a signal from a navigation sensor on a distal portion of the guide sheath. Cardiac electrical signals of the heart may be detected by electrodes disposed on the end effector of the diagnostic catheter insert. The cardiac electrical signals may be transmitted to a computing system via an electrical connection between the diagnostic catheter insert and the guide sheath. The distal portion of the guide sheath may be articulated to move the end effector of the diagnostic catheter insert across the target tissue to detect electrical signals at various locations. The diagnostic catheter insert may then be separated from the guide sheath, and the end effector may be retracted proximally through a shaft of the guide sheath to separate the diagnostic catheter insert from the guide sheath.

[0009] During the same medical procedure, an ablation catheter insert can be inserted into and coupled to the guide sheath. The position of the end effector of the ablation catheter insert can be determined based on a signal from a navigation sensor on the distal portion of the guide sheath. An electrical signal for ablating tissue can be transmitted to the end effector of the ablation catheter insert via an electrical connection between the ablation catheter insert and the guide sheath base. The distal portion of the guide sheath can be articulated to move the end effector of the ablation catheter insert across the target tissue to ablate tissue at various locations. The ablation catheter insert can be separated from the guide sheath to allow additional catheter inserts to be coupled to the guide sheath as needed. The guide sheath can be further configured to accommodate other intraluminal devices such as dilators, transseptal needles, and / or guidewires.

[0010] One exemplary system can include a guide sheath and at least one catheter insert. The guide sheath includes a sheath shaft extending along a longitudinal axis, a handle coupled to a proximal end of the sheath shaft, a first modular electrical port, and a system electrical port. The catheter insert includes a catheter shaft configured to traverse through a lumen of the sheath shaft, a proximal hub coupled to a proximal end of the catheter shaft, an electrode assembly coupled to a distal portion of the catheter shaft, and a second modular electrical port configured to mate with the first modular electrical port of the guide sheath to pass electrical signals between the electrode assembly and the system electrical port via a connection of the first modular electrical port and the second modular electrical port.

[0011] An exemplary guide sheath can include a sheath shaft, a handle, a system electrical port, and a modular electrical port. The sheath shaft has a lumen extending along a longitudinal axis and configured to receive a catheter shaft. The handle is coupled to a proximal end of the sheath shaft. The modular electrical port is configured to electrically connect the system electrical port to an electrode coupled to the catheter shaft.

[0012] An exemplary catheter insert includes a catheter shaft extending along a longitudinal axis, a proximal hub coupled to a proximal end of the catheter shaft, an electrode assembly coupled to a distal portion of the catheter shaft, and a modular electrical port configured to mate with the electrical port of the guide sheath to pass electrical signals between the electrode assembly and the electrical port of the guide sheath.

[0013] An exemplary pulmonary vein diagnostic and treatment kit includes a guide sheath, a first catheter insert, and a second catheter insert. The guide sheath includes a sheath shaft extending along a longitudinal axis, a handle coupled to a proximal end of the sheath shaft, a first modular electrical port, and a system electrical port. The first catheter insert includes a first catheter shaft configured to traverse through a lumen of the sheath shaft, a first proximal hub coupled to a proximal end of the first catheter shaft, a first electrode assembly coupled to a distal portion of the first catheter shaft, and a second modular electrical port configured to mate with the first modular electrical port of the guide sheath to pass electrical signals between the first electrode assembly and the system electrical port via a connection of the first modular electrical port and the second modular electrical port. The second catheter insert includes a second catheter shaft configured to traverse through the lumen of the sheath shaft, a second proximal hub coupled to a proximal end of the second catheter shaft, a second electrode assembly coupled to a distal portion of the second catheter shaft, and a third module electrical port configured to mate with the first module electrical port of the guide sheath to pass electrical signals between the second electrode assembly and the system electrical port via a connection of the first electrical port and the third electrical port. [Brief description of the drawings]

[0014] While the specification concludes with claims particularly pointing out and distinctly claiming the subject matter described herein, it is believed that the subject matter will be better understood from the following description of specific embodiments taken in conjunction with the accompanying drawings, in which like reference numerals identify the same elements and in which: The figures depict one or more implementations of the device of the present invention by way of example only, and not by way of limitation. [Figure 1A] FIG. 1 is a diagram of an exemplary catheter-based electrophysiology mapping and ablation system utilizing a modular catheter system. [Figure 1B] FIG. 1 is a diagram of an exemplary catheter-based electrophysiology mapping and ablation system utilizing a modular catheter system. [Diagram 2] FIG. 1 is a diagram of an exemplary modular catheter system. [Figure 3A] FIG. 2 is a diagram of a proximal portion of an exemplary catheter insert. [Figure 3B] FIG. 2 is a diagram of a distal portion of an exemplary catheter insert. [Figure 3C] FIG. 2 is a view of a distal portion of another exemplary catheter insert. [Figure 4] FIG. 1 is an isometric view of a proximal portion of a modular catheter system. [Diagram 5] 1 is a diagram of components of an exemplary catheter-based electrophysiology mapping and ablation system. [Figure 6A] FIG. 1 illustrates an exemplary modular catheter system including a catheter insert having an adjustable shaft length. [Figure 6B] FIG. 1 illustrates an exemplary modular catheter system including a catheter insert having an adjustable shaft length. [Figure 7] FIG. 1 is a diagram of an exemplary pulmonary vein diagnostic and treatment kit. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0015] The following detailed description should be read with reference to the drawings, in which like elements in different drawings are numbered the same. The drawings, which are not necessarily to scale, depict selected embodiments and are not intended to limit the scope of the invention. The detailed description illustrates, by way of example and not by way of limitation, the principles of the invention. The description clearly enables one skilled in the art to make and use the invention and describes several embodiments, adaptations, variations, alternatives and uses of the invention, including what is currently contemplated to be the best mode for carrying out the invention.

[0016] Additionally, as used herein, the terms "patient," "host," "user," and "subject" refer to any human or animal subject, and while use of the invention in a human patient represents a preferred embodiment, it is not intended to limit the systems or methods to human use. Similarly, the term "proximal" refers to a location closer to the operator, while "distal" refers to a location further away from the operator or physician.

[0017] Alternative apparatus and system features and alternative method steps are presented in the exemplary embodiments herein. Each given exemplary embodiment presented herein can be modified to include features and / or method steps presented with different exemplary embodiments herein, but such features and / or steps are compatible with the given embodiment as understood by those skilled in the art and as expressly set forth herein. Such modifications and variations are intended to be included within the scope of the claims.

[0018] The systems and methods disclosed herein are configured to perform catheter-based medical procedures utilizing multiple catheter inserts.

[0019] 1A and 1B are diagrams of an exemplary catheter-based electrophysiological mapping and ablation system 10 utilizing a modular catheter system 100. Figure 1A shows a diagnostic catheter insert 60a coupled to a guide sheath 40 during the diagnostic step of a medical procedure, and Figure 1B shows a therapeutic catheter insert 60b (also referred to herein as an ablation catheter insert) coupled to the guide sheath 40 during the therapeutic step of a medical procedure.

[0020] During a medical procedure, the guide sheath 40 can be percutaneously inserted by the physician 24 through the patient's vascular system into a chamber or vascular structure of the heart 12. A distal portion of the guide sheath 40 can be positioned within the left or right atrium near a desired location within the heart 12. Optionally, an intravascular device, such as a dilator, transseptal needle, and / or guidewire, can be inserted into the guide sheath 40 to access a target treatment site. The sheath inserts 60a, 60b can then be sequentially inserted into the guide sheath 40 such that electrode assemblies 70, 80 coupled to distal portions of the shafts of the respective catheter inserts 60a, 60b can be brought into contact with tissue at or near the target treatment site. The catheter inserts 60a, 60b can be replaced as needed during a medical procedure.

[0021] The diagnostic catheter insert 60a shown in Figure 1A is configured to sense intracardiac electrogram (IEGM) signals. During a diagnostic step, the physician 24 contacts an electrode assembly 80 of an end effector of the catheter insert 60a with the heart wall to sense a target site within the heart 12. The electrode assembly 80 includes a single, or preferably multiple, electrodes 81, optionally distributed across multiple spines 82, and configured to sense IEGM signals.

[0022] The ablation catheter insert 60b shown in FIG. 1B is configured to provide electrical signals to tissue to ablate the tissue and block abnormal electrical signals propagating through the cardiac tissue. The electrode assembly 70 of the ablation catheter insert 60b includes at least one ablation electrode 71. During the ablation step, the physician 24 places the ablation electrode 71 in contact with tissue of the heart 12 such that ablation energy can be delivered to the ablation electrode 71 to ablate the tissue.

[0023] 1A and 1B collectively, the modular catheter system 100 is configured such that each catheter insert 60a, 60b includes a proximal hub 64 that can be electrically and mechanically coupled to the handle 41 of the guide sheath 41. The guide sheath 40 includes a system electrical port 45 configured to provide electrical communication to a patient interface unit (PIU) 30. The patient interface unit (PIU) 30 is an interface configured to establish electrical communication between the catheter, the electrophysiological equipment, a power source, and a workstation 14 that controls the operation of the system 10. The electrophysiological equipment of the system 10 can include, for example, the guide sheath 40, additional catheter inserts, catheters, location pads 25, body surface ECG electrodes 18, electrode patches 38, an ablation energy generator 13, and a recorder 11. The PIU 30 includes processing capabilities for implementing real-time calculations of the position of the modular catheter system 100, performing ECG calculations, and / or controlling the electrical signals provided to perform ablation. The system 10 may further include an adapter 90 configured to provide an electrical connection between the system electrical port 45 and the PIU 30 .

[0024] During the diagnostic step (FIG. 1A), electrical signals sensed by the electrodes 81 of the electrode assembly 80 can be transmitted through conductors in the shaft of the diagnostic catheter insert 60a, through the electrical connection between the proximal hub 64 and the handle 41, through the system electrical port 45, through the adapter 90, and to the PIU 30.

[0025] The system 10 can include an ablation energy generator 13 adapted to conduct ablation energy to one or more electrodes at the distal tip of a catheter configured for ablation. The energy generated by the ablation energy generator 13 can include, but is not limited to, radiofrequency (RF) energy or pulsed-field ablation (PFA) energy, including monopolar or bipolar high-voltage DC pulses such as may be used to effect irreversible electroporation (IRE), or a combination thereof.

[0026] During the ablation step (FIG. 1B), an electrical signal can be provided from the ablation energy generator 13 to the PIU 30, through the adapter 90, through the system electrical port 45, through the electrical connection between the proximal hub 64 and the handle 41, through conductors in the shaft of the ablation catheter insert 60b, to the electrodes 71 of the electrode assembly 70, and to the target tissue.

[0027] 1A and 1B collectively, the guide sheath 40 includes a navigation sensor 50 coupled to a distal portion of the sheath shaft 42. The navigation sensor 50 is configured to track the position and orientation of the distal portions of the catheter inserts 60a, 60b including the respective electrode assemblies 70, 80. The position sensor 50 is preferably a magnetic-based position sensor including three magnetic coils for sensing three-dimensional (3D) position and orientation. The magnetic-based position sensor 50 may operate in conjunction with a location pad 25 including a plurality of magnetic coils 32 configured to generate a magnetic field within a predetermined workspace. The real-time position of the distal portions of the respective catheter inserts 60a, 60b may be tracked based on the magnetic fields generated at the location pad 25 and sensed by the magnetic-based position sensor 50. Details of magnetic-based position sensing technology are described in U.S. Pat. Nos. 5,391,199, 5,443,489, 5,558,091, 6,172,499, 6,239,724, 6,332,089, 6,484,118, 6,618,612, 6,690,963, 6,788,967, and 6,892,091, which are incorporated herein by reference.

[0028] The distal portion of the shaft 42 of the guide sheath 40 may optionally include an electrode 49 configured to sense electrical signals from an external environment, such as fluid and / or tissue. As shown, the electrode 49 may be configured as a ring electrode. The system 10 includes one or more electrode patches 38 positioned for skin contact on the patient 23 to establish a position reference for the location pads 25 and impedance-based tracking of the electrodes 49. For impedance-based tracking, a current is directed to the electrodes 49 and sensed at the electrode skin patch 38, so that the location of each electrode can be triangulated via the electrode patch 38. Details of impedance-based position tracking technology are described in U.S. Patent Nos. 7,536,218, 7,756,576, 7,848,787, 7,869,865, and 8,456,182, which are incorporated herein by reference.

[0029] The catheter inserts 60a, 60b and guide sheath 40 may be sized, shaped, and otherwise configured such that a distal portion of each of the catheter inserts 60a, 60b is in a predetermined position (or approximately a predetermined position) relative to the navigation sensor 50 (and optionally the electrodes 49) when the proximal hub 64 of each of the catheter inserts 60a, 60b is coupled to the handle 41 of the guide sheath 40. The PIU 30 may be configured to determine the position of the distal portion of the catheter inserts 60a, 60b (and thereby the electrodes 71, 81 of the electrode assemblies 70, 80 of each of the catheter inserts 60a, 60b) based at least in part on the position of the distal portion of the sheath shaft 42. The sheath shaft navigation sensor 50 is configured to provide an indication of the position of the distal portion of the catheter inserts 60a, 60b.

[0030] Optionally, the electrodes 71, 81 of the respective catheter inserts 60a, 60b may be utilized for impedance-based position tracking of the respective electrode assemblies 70, 80. For example, the electrode assemblies may include flexible features that may be configured to move within a predetermined space relative to the navigation sensor 50 (and optionally the electrodes 49 on the sheath shaft 42), and impedance-based position tracking may be used to determine the location of the electrodes within the predetermined space. In particular, the electrode assembly 80 shown in FIG. 1A includes an electrode 81 coupled to a flexible spine 82, each of which is joined to the distal end 66 of the shaft of the diagnostic catheter insert 60a. The flexible spine 82 may move within a predetermined space near the distal end 66 of the shaft of the diagnostic catheter insert 60a. The distal end 66 of the shaft of the diagnostic catheter insert 60a is in a predetermined position relative to the navigational sensor 50 (and optionally the electrodes 49 on the sheath shaft 42) and therefore the predetermined space that the flexible spine 82 can move is in a predetermined position relative to the navigational sensor 50 (and optionally the electrodes 49 on the sheath shaft 42). The electrodes 81 on the spine 82 can be positioned using impedance-based tracking to provide a more precise location of each electrode 81 within the predetermined space.

[0031] Because the position of the distal portion of each catheter insert 60a, 60b can be determined based on the position of the navigation sensor 50 (and optionally the electrode 49 on the sheath shaft 42), the catheter inserts 60a, 60b do not need to include a navigation sensor. Preferably, the distal portions of the catheter shaft inserts 60a, 60b lack an inductive navigation sensor.

[0032] As an alternative to the illustrated configuration, the catheter inserts 60a, 60b may include a guidance navigation sensor. In such an example, the distal end of the sheath shaft 42 may be determined based at least in part on the guidance navigation sensor of the catheter inserts 60a, 60a, and the sheath shaft 42 need not include the illustrated guide sensor 50. The catheter inserts 60a, 60b and the guide sheath 40 may be sized, shaped, and otherwise configured such that when the proximal hub 64 of each catheter insert 60a, 60b is coupled to the handle 41 of the guide sheath 40, the distal portion of each catheter insert 60a, 60b is in a predetermined position (or approximately in a predetermined position) relative to the guidance navigation sensor of the catheter insert. As another alternative, both the guide sheath shaft 42 and the catheter inserts 60a, 60b may include their respective guidance navigation sensors.

[0033] The workstation 14 includes a processor unit having a memory, a memory or storage device loaded with appropriate operating software, and a user interface function. The workstation 14 can be configured to provide multiple functions, optionally including: (1) modeling the endocardial anatomical structure in three dimensions (3D) and rendering the model or anatomical map 20 for display on a display device 27; (2) displaying on the display device 27 activation sequences (or other data) compiled from recorded electrograms 21 with representative visual indicia or images superimposed on the rendered anatomical map 20; (3) displaying real-time positions and orientations of distal segments within the heart chamber; and (4) displaying on the display device 27 sites of interest, such as where ablation energy has been applied. One commercially available product embodying elements of the system 10 is available as the CARTO™ 3 system, commercially available from Biosense Webster, Inc., 31A Technology Drive, Irvine, Calif., 92618. For example, the workstation 14 may be configured to provide end effector visualization 17 indicating the real-time position and orientation of the respective electrode assemblies 70, 80, and may be configured to provide sheath visualization 16 indicating the real-time position and orientation of the distal portion of the sheath shaft 42.

[0034] Recorder 11 displays electrograms 21 captured by the body surface ECG electrodes 18, and intracardiac electrograms (IEGMs) captured by electrodes 26 of catheter 14. Recorder 11 may include pacing capability for pacing the cardiac rhythm and / or may be electrically connected to a stand-alone pacer.

[0035] System 10 may further include an irrigation system 15 configured to provide irrigation fluid to guide sheath 40 and / or catheter inserts 60a, 60b. Handle 41 of guide sheath 40 can be connected to irrigation system 15 by irrigation line 19. As shown in FIG. 1B, proximal hub 64 of ablation catheter insert 60b can be connected to irrigation system 15 by irrigation line 22. Modular system 100 can be configured such that irrigation fluid can be provided to the lumen of the guide sheath independent of irrigation provided to ablation catheter insert 60b.

[0036] The system 10 may further include an implant and an implant delivery system (not shown), such as a left atrial appendage closure (LAAO) device and associated delivery system, or other such vascular or cardiac implants and delivery systems as would be understood by one of ordinary skill in the art. The implant may be delivered to the treatment site through the guide sheath 40 using the implant delivery system. A navigation sensor 50 may be utilized to determine the position of the sheath distal end 48. The implant may be inserted within the hemostatic valve 51 of the guide sheath 40 and manipulated by the implant delivery system to push the implant distally through the sheath shaft 42 and out the distal end 48 of the guide sheath 40 at the treatment site. The implant may then be deployed and the delivery system may be retracted proximally from the guide sheath 40.

[0037] FIG. 2 is a diagram of an exemplary modular catheter system 100 including a guide sheath 40 and a catheter insert 60. The modular catheter system 100 is shown configured as described in connection with FIGS. 1A and 1B and including an ablation catheter insert configured similarly to the ablation catheter insert 60b shown in FIG. 1B. The guide sheath 40 includes a handle 41, a sheath shaft 42 extending distally from the handle 41, a modular electrical port 46, a system electrical port 45, a navigation sensor 50, and a ring electrode 49 configured as disclosed in connection with FIGS. 1A and 1B. The catheter insert 60 includes a proximal hub 60 and an electrode assembly 70 configured as disclosed in connection with FIG. 1B. The modular catheter system 100 may further include a diagnostic catheter insert 60 including an electrode assembly 80 configured as disclosed in connection with FIG. 1A, which may be interchangeable with the illustrated catheter insert 60.

[0038] The guide sheath 40 includes a first modular electrical port 46, and the catheter insert 60 includes a second modular electrical port 61 configured to mate with the first modular electrical port 46 to pass electrical signals between the electrode assembly 70 and the system electrical port 45. The first and second modular electrical ports 46, 61 may be further configured to mechanically couple to one another, thereby fixing the position of the proximal hub 64 relative to the sheath handle 41. To couple the guide sheath 40 to the catheter insert 60, the distal end 72 of the sheath insert 60 is inserted into the opening of the hemostasis valve 51 at the proximal end of the sheath handle 41, and the shaft 62 of the catheter insert 60 is pushed distally through the sheath shaft 47. The second modular electrical port 61 of the catheter insert 60 is then inserted into the first modular electrical port 46 of the guide sheath 40. Once coupled, the distal portion of the catheter insert 60, including the electrode assembly 70, extends a predetermined length from the distal end 48 of the sheath shaft 47.

[0039] The sheath shaft 42 extends along a longitudinal axis AA. The sheath shaft 42 may be configured to deflect from the longitudinal axis as shown. The sheath handle 41 may include a deflection knob 43 configured to be manipulated to deflect a distal portion of the sheath shaft 42 and a distal portion of the catheter shaft 62 from the longitudinal axis. The modular catheter system 100 may be configured such that the distal portion of the catheter shaft 62 cannot be deflected independently of the guide sheath 40. The catheter insert 60 may be devoid of a mechanism (e.g., a puller wire) to deflect the distal portion of the catheter shaft from the longitudinal axis AA, and deflection of the sheath shaft 42 alone may be sufficient to position the electrode assembly 70 at a desired location during a medical procedure.

[0040] The guide sheath 40 may further include an irrigation port 44 configured to couple to the irrigation system 15 (FIGS. 1A and 1B). The catheter insert 60 may further include an irrigation port 63 configured to couple to the irrigation system 15 (FIGS. 1A and 1B).

[0041] The catheter insert 60 need not include navigation sensors and associated electrical conductors through the catheter shaft 62, and the catheter insert 60 need not include a deflection mechanism, such as a puller wire. Thus, the catheter insert 60 can be made less expensive and / or with a smaller French size compared to respective diagnostic or therapeutic catheters configured with independent navigation and / or deflection. The reduced French size of the catheter insert 60 can further result in the outer diameter of the guide sheath 40 being smaller than comparable guide sheaths known in the art, thereby resulting in easier intravenous translation and smaller incision size.

[0042] Additionally, the guide sheath 40 and catheter insert 60 may be easier to manipulate by physician 23 than a comparable system that includes a guide sheath and catheter that are independent of one another. When combined, the proximal hub 64 can essentially function as an extension of the guide sheath handle 41, thus providing only one handle to manipulate rather than the two used in existing procedures. The electrical connection between the guide sheath 40 and the catheter insert allows for a single electrical cable to provide the electrical connection to the PIU 30, reducing potential tangling of the electrical cables as compared to systems having separate electrical cables for the guide sheath and catheter.

[0043] 3A is a view of the proximal portion of an exemplary catheter insert 60, showing the proximal hub 64, the second modular electrical port 61, and the proximal portion of the catheter shaft 62. The catheter insert 60 further includes an optional irrigation port 63 as shown.

[0044] 3B is a diagram of a distal portion of an exemplary ablation catheter insert including an electrode assembly 70 having an ablation electrode 71. The ablation electrode 71 is preferably configured to provide irrigation fluid to the treatment site, and thus the ablation catheter insert preferably includes irrigation ports 63 (FIG. 3A). The ablation catheter insert can include a variety of end effector configurations, including balloons, baskets, rays, meshes, and other suitable electrode arrangements, as will be appreciated by those skilled in the art.

[0045] 3C is a diagram of a distal portion of an exemplary diagnostic catheter insert including an electrode assembly 80 having an electrode 81 configured to sense IEGM signals. The diagnostic catheter may not require irrigation and therefore may lack irrigation port 63 (FIG. 3A). The diagnostic catheter insert may include a variety of end effector configurations, including balloons, baskets, lays, meshes, and other suitable electrode arrangements, as will be appreciated by those skilled in the art.

[0046] As another example, the catheter insert 60 may be configured to provide visualization of the treatment area. For example, the visualization catheter insert may include an ultrasound probe near the distal end of the visualization catheter. The distal portion of such a visualization catheter insert may be determined as generally described in connection with the catheter insert 60.

[0047] 4 is an isometric view of the modular catheter system 100. The shaft 62 of the catheter insert 60 is inserted into the proximal end of the hemostasis valve 51 of the guide sheath 40. The catheter insert 60 can be moved distally relative to the guide sheath 40 to mate the second modular electrical port 61 of the catheter insert 60 with the first modular electrical port 46 of the guide sheath 40.

[0048] FIG. 5 is a diagram of components of an exemplary catheter-based electrophysiology mapping and ablation system configured similarly to the system 10 disclosed in connection with FIGS. 1A and 1B. The adapter 90 includes a sheath electrical connector 91, a splitter 92, a diagnostic electrode connector 93, a mapping connector 94, and an ablation generator connector 95. The sheath electrical connector 91 is configured to electrically couple to the system electrical port 45 of the guide sheath 40. The diagnostic electrode connector 93 is configured to transmit electrical signals from the electrode assembly of the diagnostic catheter insert to the PIU 30. The mapping connector 94 is configured to electrically couple the navigation sensor 50 (and optionally the electrode 49) to the PIU 30. The ablation generator connector 95 is configured to electrically couple the ablation electrode 71 to the PIU 30. The splitter 92 is configured to route electrical signals between the single sheath electrical connector 91 and the three PIU electrical connectors 93, 94, 95.

[0049] 6A and 6B are diagrams of an exemplary assembly including a guide sheath 40 and a catheter insert 60 having an adjustable shaft length. A proximal hub 64 of the catheter insert 60 includes an extension lever 65 configured to move the catheter shaft 62 proximally and distally by a length L1 such that the catheter shaft 62 can extend and retract from the distal end 48 of the guide sheath 40 by a length L1. The proximal hub 64 may further be configured with an electrical sensor in electrical communication with the second modular electrical port 61, which may be configured to provide an electrical signal indicative of a length of extension of the distal portion of the catheter insert 60 from the distal end 48 of the guide sheath 40. The electrical sensor may be electrically coupled to the second modular electrical port 61 (FIG. 4) such that the electrical sensor may be electrically coupled to a computing system such as the workstation 13 or the PIU 30 (FIGS. 1A and 1B) via a connection between the first modular electrical port 46 and the second modular electrical port 61. The computing system can be configured to determine a position of the electrode assembly 70 of the catheter insert 60 based at least in part on the length of extension of the distal portion of the catheter insert 60. The illustrated electrode assembly 70 can have an end effector design similar to existing ablation and / or diagnostic catheters, alternatives thereof, and variations thereof, including those yet to be developed, as will be understood by those skilled in the art.

[0050] 7 is a diagram of an exemplary pulmonary vein diagnostic and treatment kit 101. Kit 101 includes guide sheath 40, diagnostic catheter insert 60a, and treatment catheter insert 60b, configured as disclosed elsewhere herein. Treatment kit 101 may further include accessories such as dilator 33 and guidewire 34 (shown within guidewire sheath 35).

[0051] The following clauses list non-limiting embodiments of the present disclosure.

[0052] Clause 1. A system comprising a guide sheath and a catheter insert, the guide sheath comprising a sheath shaft extending along a longitudinal axis, a handle coupled to a proximal end of the sheath shaft, a first modular electrical port, and a system electrical port, the catheter insert comprising a catheter shaft configured to traverse a lumen of the sheath shaft, a proximal hub coupled to a proximal end of the catheter shaft, an electrode assembly coupled to a distal portion of the catheter shaft, and a second modular electrical port configured to mate with the first modular electrical port of the guide sheath to pass electrical signals between the electrode assembly and the system electrical port via a connection between the first modular electrical port and the second modular electrical port.

[0053] Clause 2. The system described in clause 1, wherein the guide sheath is coupled to a distal portion of the sheath shaft and includes a navigation sensor electrically connected to the system electrical port.

[0054] Clause 3. The system of clause 2, wherein the navigation sensor is configured to provide an indication of a position of a distal portion of the catheter insert.

[0055] Clause 4. A system described in any one of clauses 1 to 3, wherein the distal portion of the catheter shaft is devoid of an inductive navigation sensor.

[0056] Clause 5. A system described in any one of clauses 1 to 4, wherein the handle of the guide sheath includes a deflection knob configured to be manipulated to deflect the distal portion of the sheath shaft and the distal portion of the catheter shaft from the longitudinal axis.

[0057] Clause 6. A system described in any one of clauses 1 to 5, wherein the catheter insert lacks a mechanism for deflecting the distal portion of the catheter shaft.

[0058] Clause 7. A system described in any one of clauses 1 to 6, wherein the distal portion of the catheter shaft cannot be deflected independently of the guide sheath.

[0059] Clause 8. The system of any one of clauses 1-7, wherein a first modular electrical port of the sheath insert is coupled to a handle of the guide sheath and a second modular electrical port of the catheter insert is coupled to a proximal hub of the catheter insert, and the first modular electrical port and the second modular electrical port are configured to mechanically couple to each other, thereby fixing the position of the hub relative to the handle.

[0060] Clause 9. A system described in any one of clauses 1 to 8, wherein the handle comprises a hemostasis valve configured to receive the catheter shaft.

[0061] Clause 10. A system described in any one of clauses 1 to 9, wherein the guide sheath further comprises an irrigation port fluidly coupled to the lumen of the sheath shaft.

[0062] Clause 11. A system described in any one of clauses 1 to 10, wherein the electrode assembly comprises one or more ablation electrodes configured to ablate cardiac tissue.

[0063] Clause 12. The system described in clause 11, wherein the one or more ablation electrodes are configured to ablate cardiac tissue using radio frequency ablation electrical signals and / or pulsed field ablation electrical signals.

[0064] Clause 13. A system described in any one of clauses 1 to 12, wherein the guide sheath is configured to provide a cardiac ablation electrical signal from the system electrical port to the first modular electrical port.

[0065] Clause 14. The system of any one of clauses 1 to 13, further comprising an ablation generator configured to couple to the system electrical port and provide a cardiac ablation electrical signal to the electrode assembly via a connection of the first modular electrical port and the second modular electrical port.

[0066] Clause 15. The system of any one of clauses 1-14, wherein the catheter insert further comprises an irrigation port coupled to a proximal hub of the catheter insert and configured to provide irrigation fluid to a distal portion of the catheter shaft.

[0067] Clause 16. A system described in any one of clauses 1 to 15, wherein the electrode assembly is configured to sense cardiac electrical signals from cardiac tissue.

[0068] Clause 17. A system described in any one of clauses 1 to 16, wherein the electrode assembly comprises a plurality of diagnostic electrodes configured to sense cardiac electrical signals from cardiac tissue.

[0069] Clause 18. The system described in clause 17, wherein the electrode assembly is configured to transition through the lumen of the guide sheath in a folded configuration aligned with the longitudinal axis and comprises a plurality of spines configured to expand away from the longitudinal axis upon exiting the distal end of the guide sheath, and a plurality of diagnostic electrodes are coupled to the plurality of spines.

[0070] Clause 19. A system described in any one of clauses 16 to 18, wherein the guide sheath is configured to receive a cardiac electrical signal at a first modular electrical port and transmit the cardiac electrical signal to the system electrical port.

[0071] Clause 20. The system of any one of clauses 1-10, comprising a first catheter insert and a second catheter insert, the first catheter insert comprising a second catheter shaft configured to traverse through a lumen of the sheath shaft, a second proximal hub coupled to a proximal end of the second catheter shaft, a second electrode assembly coupled to a distal portion of the second catheter shaft, and a third modular electrical port configured to mate with the first modular electrical port of the guide sheath to pass electrical signals between the second electrode assembly and the system electrical port via a connection of the first modular electrical port and the third modular electrical port, the second electrode assembly comprising an electrode configuration different from the electrode configuration of the electrode assembly of the first catheter insert.

[0072] Clause 21. The system described in clause 20, wherein the electrode assembly of the first catheter insert is configured to ablate cardiac tissue and the second electrode assembly of the second catheter insert is configured to sense cardiac electrical signals from the cardiac tissue.

[0073] Clause 22. A system as described in any one of clauses 1 to 21, comprising an adapter configured to electrically couple the system electrical port to a computing system and an ablation generator, the computing system configured to receive cardiac electrical signals from the cardiac tissue via the adapter, and the ablation generator configured to provide an ablation electrical signal via the adapter.

[0074] Clause 23. The system described in Clause 22, wherein the guide sheath is coupled to a distal portion of the sheath shaft and includes a navigation sensor electrically connected to the system electrical port, and the computing system is configured to determine a position of the distal portion of the sheath shaft based at least in part on a navigation electrical signal received from the navigation sensor via the adapter.

[0075] Clause 24. The system of any one of clauses 1 to 23, further comprising an implant and an implant delivery system configured to deliver the implant to the treatment site through the guide sheath.

[0076] Clause 25. A guide sheath comprising: a sheath shaft having a lumen extending along a longitudinal axis and configured to receive a catheter shaft; a handle coupled to a proximal end of the sheath shaft; a system electrical port; and a modular electrical port configured to electrically connect an electrode coupled to the catheter shaft to the system electrical port.

[0077] Clause 26. The guide sheath of clause 25, further comprising a navigation sensor coupled to a distal portion of the sheath shaft, the navigation sensor being electrically connected to the system electrical port.

[0078] Clause 27. The guide sheath of clause 26, wherein the navigation sensor is configured to provide an indication of a position of an electrode coupled to the catheter shaft.

[0079] Clause 28. A guide sheath as described in any one of clauses 25 to 27, wherein the handle comprises a deflection knob configured to be manipulated to deflect a distal portion of the sheath shaft from the longitudinal axis.

[0080] Clause 29. A guide sheath as described in any one of clauses 25 to 28, wherein the handle is provided with a hemostasis valve configured to receive the catheter shaft.

[0081] Clause 30. A guide sheath as described in any one of clauses 25 to 29, further comprising an irrigation port fluidly coupled to the lumen.

[0082] Clause 331. A guide sheath described in any one of clauses 25 to 30, further comprising an electrical connection between the system electrical port and the modular electrical port configured to transmit a cardiac ablation electrical signal from the system electrical port to the modular electrical port.

[0083] Clause 32. A guide sheath described in any one of clauses 25 to 31, further comprising an electrical connection between the system electrical port and the modular electrical port configured to transmit a cardiac electrical signal from the modular electrical port to the system electrical port.

[0084] Clause 33. A guide sheath as described in any one of clauses 25 to 32, wherein the modular electrical port is configured such that during a medical procedure, the modular electrical port is configured to electrically couple to a first electrode assembly of a first catheter insert, disconnect from the first electrode assembly of the first catheter insert, and connect to a second electrode assembly of a second catheter insert.

[0085] Clause 34. A catheter insert comprising: a catheter shaft extending along a longitudinal axis, a proximal hub coupled to a proximal end of the catheter shaft, an electrode assembly coupled to a distal portion of the catheter shaft, and a modular electrical port configured to mate with an electrical port of a guide sheath to pass electrical signals between the electrode assembly and the electrical port of the guide sheath.

[0086] Clause 35. A catheter insert as described in clause 34, wherein the distal portion of the catheter shaft is free of a navigation sensor.

[0087] Clause 36. A catheter insert as described in clause 34 or 35, wherein the catheter insert lacks a mechanism for deflecting the distal portion of the catheter shaft.

[0088] Clause 37. A catheter insert as described in any one of clauses 34 to 36, wherein the electrode assembly comprises one or more ablation electrodes configured to ablate cardiac tissue.

[0089] Clause 38. The catheter insert of clause 37, wherein one or more ablation electrodes are configured to ablate cardiac tissue using radiofrequency ablation electrical signals and / or pulsed field ablation electrical signals.

[0090] Clause 39. A catheter insert described in any one of clauses 34 to 38, further comprising an irrigation port coupled to the proximal hub and configured to provide irrigation fluid to a distal portion of the catheter shaft.

[0091] Clause 40. A catheter insert as described in any one of clauses 34 to 39, wherein the electrode assembly is configured to sense cardiac electrical signals from cardiac tissue.

[0092] Clause 41. A catheter insert as described in any one of clauses 34 to 40, wherein the electrode assembly comprises a plurality of diagnostic electrodes configured to sense cardiac electrical signals from cardiac tissue.

[0093] Clause 42. A catheter insert as described in clause 41, wherein the electrode assembly comprises a plurality of spines configured to transition through the lumen of the guide sheath in a folded configuration aligned with the longitudinal axis and configured to expand away from the longitudinal axis upon exiting the distal end of the guide sheath, and a plurality of diagnostic electrodes are coupled to the plurality of spines.

[0094] Clause 43. A pulmonary vein diagnostic and treatment kit comprising a guide sheath, a first catheter insert, and a second catheter insert, wherein the guide sheath comprises a sheath shaft extending along a longitudinal axis, a handle coupled to a proximal end of the sheath shaft, a first modular electrical port, and a system electrical port, and the first catheter insert comprises a first catheter shaft configured to traverse through a lumen of the sheath shaft, a first proximal hub coupled to a proximal end of the first catheter shaft, a first electrode assembly coupled to a distal portion of the first catheter shaft, and a second modular electrical port adapted to mate with the first modular electrical port of the guide sheath to connect the first modular electrical port and the second modular electrical port to the sheath shaft. a second modular electrical port configured to pass electrical signals between the first electrode assembly and the system electrical port via a connection of the air port, wherein the second catheter insert comprises a second catheter shaft configured to traverse through a lumen of the sheath shaft, a second proximal hub coupled to a proximal end of the second catheter shaft, a second electrode assembly coupled to a distal portion of the second catheter shaft, and a third modular electrical port configured to mate with the first modular electrical port of the guide sheath to pass electrical signals between the second electrode assembly and the system electrical port via a connection of the first electrical port and the third electrical port.

[0095] Clause 44. A pulmonary vein diagnostic and treatment kit as described in Clause 43, wherein the first electrode assembly is configured to ablate tissue and the connection of the first modular electrical port and the second modular electrical port is configured to pass an ablation electrical signal from the system port to the first electrode assembly.

[0096] Clause 45. A pulmonary vein diagnostic and treatment kit as described in clause 43 or 44, wherein the second electrode assembly is configured to sense electrical signals from the cardiac tissue, and the connection of the first modular electrical port and the third modular electrical port is configured to pass the sensed electrical signals from the second electrode assembly to the system port.

[0097] Clause 46. A pulmonary vein diagnostic and treatment kit as described in any one of clauses 42 to 43, further comprising an expander configured to traverse the lumen of the guide sheath, and a needle configured to traverse the lumen of the expander.

[0098] Clause 47. A method of performing pulmonary vein isolation, comprising: positioning a distal portion of a guide sheath near a target tissue in a heart; inserting a distal portion of a diagnostic catheter insert into a shaft of the guide sheath; extending the distal portion of the catheter insert from a distal end of the guide sheath; coupling a proximal hub of the diagnostic catheter insert to the guide sheath; determining a position of the distal portion of the diagnostic catheter based at least in part on an electrical signal from a navigation sensor coupled to the distal portion of the guide sheath; sensing cardiac signals using an electrode array on the distal portion of the diagnostic catheter insert; isolating the proximal hub of the diagnostic catheter insert from the guide sheath; and coupling the distal portion of the diagnostic catheter insert to a guide sheath. and withdrawing the distal portion of the ablation catheter insert from the shaft of the guide sheath; inserting a distal portion of the ablation catheter into the shaft of the guide sheath; coupling a proximal hub of the ablation catheter insert to the guide sheath; determining a position of the distal portion of the ablation catheter based at least in part on an electrical signal from a navigation sensor coupled to the distal portion of the guide sheath; applying ablation energy to the target tissue using an electrode array on the distal portion of the ablation catheter insert; separating the proximal hub of the ablation catheter insert from the guide sheath; and withdrawing the distal portion of the ablation catheter insert from the shaft of the guide sheath.

[0099] Clause 48. The method of clause 47, wherein the guide sheath, the diagnostic catheter insert, and the ablation catheter insert each include a respective modular electrical port, and wherein coupling the proximal hub of the diagnostic catheter insert to the guide sheath comprises mating the modular electrical port of the guide sheath to the modular electrical port of the diagnostic catheter insert, sensing a cardiac signal using an electrode array of a distal portion of the diagnostic catheter insert comprises transmitting a cardiac electrical signal through a connection between the modular electrical port of the guide sheath and the modular electrical port of the diagnostic catheter insert, coupling the proximal hub of the ablation catheter insert to the guide sheath comprises mating the modular electrical port of the guide sheath to the modular electrical port of the ablation catheter insert, and applying ablation energy to the target tissue using an electrode array of a distal portion of the ablation catheter insert comprises delivering an electrical signal through a connection between the modular electrical port of the guide sheath and the modular electrical port of the ablation catheter insert.

[0100] Clause 49. The method of clause 47 or 48, comprising, independently of each other, irrigating the ablation catheter and irrigating the guide sheath.

[0101] Although exemplary embodiments of the subject matter encompassed by the present invention have been shown and described, further adaptations of the methods and systems described herein may be achieved by appropriate modifications without departing from the scope of the claims. For example, the distal portions of the illustrated catheter inserts 60, 60a, 60b may have a variety of alternative end effector configurations, including balloons, baskets, lays, meshes, and other suitable electrode arrangements, as will be understood by those skilled in the art. The illustrated electrode assemblies 70, 80 may have a variety of alternative end effector designs, which may be similar to existing ablation and / or diagnostic catheters, alternatives thereof, and variations thereof, including those yet to be developed, as will be understood by those skilled in the art.

[0102] Furthermore, where the methods and steps described above show certain events occurring in a particular order, it is intended that the particular steps do not have to be performed in the order described, but rather that the steps may be performed in any order as long as they enable the embodiment to function for their intended purpose. Therefore, to the extent there are variations of the invention that are within the spirit of the disclosure or equivalent to the invention found in the claims, the patent is intended to cover those variations as well. Some such modifications should be apparent to those skilled in the art. For example, the above examples, embodiments, geometries, materials, dimensions, proportions, steps, etc. are exemplary. Thus, the claims should not be limited to the specific details of structure and operation described in the specification and drawings.

[0103] [Embodiment] (1) A system comprising: A guide sheath, a sheath shaft extending along a longitudinal axis; a handle coupled to a proximal end of the sheath shaft; a first modular electrical port; a guide sheath having a system electrical port; A catheter insert comprising: a catheter shaft configured to traverse through a lumen of the sheath shaft; a proximal hub coupled to a proximal end of the catheter shaft; an electrode assembly coupled to a distal portion of the catheter shaft; a catheter insert comprising a second modular electrical port configured to mate with the first modular electrical port of the guide sheath to pass electrical signals between the electrode assembly and the system electrical port via a connection of the first modular electrical port and the second modular electrical port. (2) The system of embodiment 1, wherein the guide sheath comprises a navigation sensor coupled to a distal portion of the sheath shaft and electrically connected to the system electrical port. (3) The system of embodiment 2, wherein the navigation sensor is configured to provide an indication of the position of the distal portion of the catheter insert. (4) The system of embodiment 1, wherein the handle of the guide sheath comprises a deflection knob configured to be manipulated to deflect a distal portion of the sheath shaft and a distal portion of the catheter shaft from the longitudinal axis. (5) The system of embodiment 1, wherein the distal portion of the catheter shaft cannot be deflected independently of the guide sheath.

[0104] (6) the first modular electrical port of the guide sheath is coupled to the handle of the guide sheath; the second modular electrical port of the catheter insert is coupled to the proximal hub of the catheter insert; The system of embodiment 1, wherein the first modular electrical port and the second modular electrical port are configured to mechanically couple to each other, thereby fixing the position of the proximal hub relative to the handle. (7) The system of embodiment 1, wherein the handle comprises a hemostasis valve configured to receive the catheter shaft. (8) The system of embodiment 1, wherein the guide sheath further comprises an irrigation port fluidly coupled to the lumen of the sheath shaft. (9) The system of embodiment 1, wherein the electrode assembly comprises one or more ablation electrodes configured to ablate cardiac tissue. (10) The system of embodiment 9, wherein the one or more ablation electrodes are configured to ablate cardiac tissue using radio frequency ablation electrical signals and / or pulsed field ablation electrical signals.

[0105] (11) The system of embodiment 1, wherein the guide sheath is configured to provide a cardiac ablation electrical signal from the system electrical port to the first modular electrical port. (12) The system of embodiment 1, wherein the catheter insert further comprises an irrigation port coupled to the proximal hub of the catheter insert and configured to provide irrigation fluid to the distal portion of the catheter shaft. (13) The system of embodiment 1, wherein the electrode assembly is configured to sense cardiac electrical signals from cardiac tissue. (14) The system of embodiment 13, wherein the electrode assembly comprises a plurality of diagnostic electrodes configured to sense cardiac electrical signals from cardiac tissue. (15) The system of embodiment 14, wherein the electrode assembly comprises a plurality of spines configured to transition through the lumen of the guide sheath in a folded configuration aligned with the longitudinal axis and configured to expand away from the longitudinal axis upon exiting a distal end of the guide sheath, and the plurality of diagnostic electrodes are coupled to the plurality of spines.

[0106] (16) The system of embodiment 13, wherein the guide sheath is configured to receive the cardiac electrical signal at the first modular electrical port and transmit the cardiac electrical signal to the system electrical port. (17) A method for treating a vascular endovascular disease comprising the steps of: (a) providing a vascular endovascular system comprising: a first catheter insert and a second catheter insert; the second catheter insert comprises a second catheter shaft configured to traverse through the lumen of the sheath shaft, a second proximal hub coupled to a proximal end of the second catheter shaft, a second electrode assembly coupled to a distal portion of the second catheter shaft, and a third modular electrical port configured to mate with the first modular electrical port of the guide sheath to pass electrical signals between the second electrode assembly and the system electrical port via a connection of the first modular electrical port and the third modular electrical port; 2. The system of embodiment 1, wherein the second electrode assembly has an electrode configuration that is different from the electrode configuration of the electrode assembly of the first catheter insert. (18) The electrode assembly of the first catheter insert is configured to ablate cardiac tissue; 18. The system of embodiment 17, wherein the second electrode assembly of the second catheter insert is configured to sense cardiac electrical signals from cardiac tissue. (19) An adapter configured to electrically couple the system electrical port to a computing system and an ablation generator, the computing system configured to receive cardiac electrical signals from cardiac tissue via the adapter, and the ablation generator configured to provide ablation electrical signals via the adapter; the guide sheath including a navigation sensor coupled to a distal portion of the sheath shaft and electrically connected to the system electrical port; The system of embodiment 1, wherein the computing system is configured to determine a position of the distal portion of the sheath shaft based at least in part on a navigation electrical signal received from the navigation sensor via the adapter. (20) Implants; 2. The system of embodiment 1, further comprising an implant delivery system configured to deliver the implant through the guide sheath to a treatment site.

Claims

1. 1. A system comprising: A guide sheath, a sheath shaft extending along a longitudinal axis; a handle coupled to a proximal end of the sheath shaft; a first modular electrical port; a guide sheath having a system electrical port; A catheter insert comprising: a catheter shaft configured to traverse through a lumen of the sheath shaft; a proximal hub coupled to a proximal end of the catheter shaft; an electrode assembly coupled to a distal portion of the catheter shaft; a catheter insert comprising: a second modular electrical port configured to mate with the first modular electrical port of the guide sheath to pass electrical signals between the electrode assembly and the system electrical port via a connection of the first modular electrical port and the second modular electrical port.

2. The system of claim 1 , wherein the guide sheath comprises a navigation sensor coupled to a distal portion of the sheath shaft and electrically connected to the system electrical port.

3. The system of claim 2 , wherein the navigational sensor is configured to provide an indication of a position of the distal portion of the catheter insert.

4. The system of claim 1 , wherein the handle of the guide sheath comprises a deflection knob configured to be manipulated to deflect a distal portion of the sheath shaft and a distal portion of the catheter shaft from the longitudinal axis.

5. The system of claim 1 , wherein the distal portion of the catheter shaft cannot be deflected independently of the guide sheath.

6. the first modular electrical port of the guide sheath is coupled to the handle of the guide sheath; the second modular electrical port of the catheter insert is coupled to the proximal hub of the catheter insert; The system of claim 1 , wherein the first modular electrical port and the second modular electrical port are configured to mechanically couple to one another, thereby fixing a position of the proximal hub relative to the handle.

7. The system of claim 1 , wherein the handle comprises a hemostasis valve configured to receive the catheter shaft.

8. The system of claim 1 , wherein the guide sheath further comprises an irrigation port fluidly coupled to the lumen of the sheath shaft.

9. The system of claim 1 , wherein the electrode assembly comprises one or more ablation electrodes configured to ablate cardiac tissue.

10. 10. The system of claim 9, wherein the one or more ablation electrodes are configured to ablate cardiac tissue using radio frequency ablation electrical signals and / or pulsed field ablation electrical signals.

11. The system of claim 1 , wherein the guide sheath is configured to provide a cardiac ablation electrical signal from the system electrical port to the first modular electrical port.

12. 10. The system of claim 1, wherein the catheter insert further comprises an irrigation port coupled to the proximal hub of the catheter insert and configured to provide irrigation fluid to the distal portion of the catheter shaft.

13. The system of claim 1 , wherein the electrode assembly is configured to sense cardiac electrical signals from cardiac tissue.

14. The system of claim 13 , wherein the electrode assembly comprises a plurality of diagnostic electrodes configured to sense cardiac electrical signals from cardiac tissue.

15. 15. The system of claim 14, wherein the electrode assembly comprises a plurality of spines configured to transition through the lumen of the guide sheath in a folded configuration aligned with the longitudinal axis and configured to expand away from the longitudinal axis upon exiting a distal end of the guide sheath, the plurality of diagnostic electrodes being coupled to the plurality of spines.

16. 14. The system of claim 13, wherein the guide sheath is configured to receive the cardiac electrical signal at the first modular electrical port and transmit the cardiac electrical signal to the system electrical port.

17. a first catheter insert and a second catheter insert, the first catheter insert including the catheter insert; the second catheter insert comprises a second catheter shaft configured to traverse through the lumen of the sheath shaft, a second proximal hub coupled to a proximal end of the second catheter shaft, a second electrode assembly coupled to a distal portion of the second catheter shaft, and a third modular electrical port configured to mate with the first modular electrical port of the guide sheath to pass electrical signals between the second electrode assembly and the system electrical port via a connection of the first modular electrical port and the third modular electrical port; The system of claim 1 , wherein the second electrode assembly comprises an electrode configuration that is different from an electrode configuration of the electrode assembly of the first catheter insert.

18. the electrode assembly of the first catheter insert is configured to ablate cardiac tissue; 20. The system of claim 17, wherein the second electrode assembly of the second catheter insert is configured to sense cardiac electrical signals from cardiac tissue.

19. an adapter configured to electrically couple the system electrical port to a computing system and an ablation generator, the computing system configured to receive cardiac electrical signals from cardiac tissue via the adapter, and the ablation generator configured to provide ablation electrical signals via the adapter; the guide sheath including a navigation sensor coupled to a distal portion of the sheath shaft and electrically connected to the system electrical port; The system of claim 1 , wherein the computing system is configured to determine a position of the distal portion of the sheath shaft based at least in part on a navigation electrical signal received from the navigation sensor via the adapter.

20. Implants and The system of claim 1 , further comprising an implant delivery system configured to deliver the implant through the guide sheath to a treatment site.

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