Modular steerable sheath and catheter

Abstract

A modular catheter system includes a guide sheath and a plurality of catheter inserts configured to be coupled to the guide sheath. The guide sheath may include a navigation sensor coupled to a distal portion of the guide sheath shaft. A position of a distal portion of a respective catheter insert may be determined based on an electrical signal from a navigation sensor. The catheter inserts may be electrically coupled to the guide sheath to provide an electrical connection with the electrode assembly on the distal portion of the respective catheter insert. The guide sheath may include a deflection mechanism that deflects a distal portion of the guide 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 need for a navigation sensor or deflection mechanism for the catheter insert.

Description

Technical Field

[0001] The present disclosure relates generally to medical devices, and in particular to navigation and tracking of endoluminal devices, particularly catheters and introducer sheaths. Background Art

[0002] 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 irregular heartbeat. By selectively ablating cardiac tissue through the application of energy via a catheter, it is sometimes possible to stop or alter the propagation of unwanted electrical signals from one part of the heart to another.

[0003] Many contemporary ablation methods utilize radiofrequency (RF) electrical energy to heat tissue. Irreversible electroporation (IRE) is an alternative to RF ablation. To achieve IRE, short pulses of high-voltage electrical signals (pulsed field ablation electrical signals) are delivered to tissue; the electrical signals generate irreversible cell membrane permeabilization. The use of multi-electrode catheters to deliver IRE energy to tissue has been previously proposed in the patent literature. Examples of systems and devices configured for IRE ablation are disclosed in U.S. Patent Publications 2021 / 0169550A1, 2021 / 0169567A1, 2021 / 0169568A1, 2021 / 0161592A1, 2021 / 0196372A1, 2021 / 0177503A1, and 2021 / 0186604A1, each of which is incorporated herein by reference.

[0004] Areas of cardiac tissue may be mapped by catheter to identify abnormal electrical signals. Some catheter ablation procedures, particularly those with persistent atrial fibrillation, may be performed using electrophysiological (EP) mapping of target areas of abnormal electrical signals. Such EP mapping may include the use of sensing electrodes configured to monitor electrical signals within the cardiovascular system to accurately determine the location of abnormal conductive tissue sites that cause arrhythmias. An example of an EP mapping system is described in U.S. Patent No. 5,738,096, which is incorporated herein by reference and is attached hereto in the Appendix. Examples of EP mapping catheters are described in U.S. Patent 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 is attached hereto in the Appendix.

[0005] In addition to using EP mapping, some catheter ablation procedures can also be performed using an image-guided surgery (IGS) system. An IGS system can enable a physician to visually track the position of a catheter in a patient relative to an image of the patient's anatomy in real time. Some systems can provide a combination of EP mapping and IGS functionality, including the CARTO An example of a catheter configured for use with an IGS system is disclosed in U.S. Patent No. 9,480,416, which is incorporated herein by reference and is attached hereto as an appendix.

[0006] Many catheter-based medical procedures utilize multiple catheters during the medical procedure. In such procedures, a guide sheath having a lumen therethrough is positioned to provide intravenous access to the 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 TRANSPORT® by Biosense Webster, Inc. of Irvine, Calif. Bidirectional guide sheath, OCTARAY TM Mapping catheters and THERMOCOOL SF catheter. Summary of the invention

[0007] The system disclosed herein includes a steerable catheter or guide sheath and a modular catheter insert, which can be connected to the steerable catheter or guide sheath (referred to as the guide sheath herein). The guide sheath includes a handle, which can include an electrical connector, which is configured to be connected to the electrical connector of the modular catheter insert so that the electrical signal measured at the target area and / or the electrical signal delivered to the target area passes through the handle of the guide sheath. The guide sheath also includes an axis having a lumen passing therethrough, and can include a navigation sensor connected to the distal portion of the axis. The catheter insert can be configured to be connected to the guide sheath so that the position of the distal portion of the catheter insert can be determined based on the electrical signal of the navigation sensor on the distal portion of the guide sheath.

[0008] The system is configured so that modular catheter inserts can be interchanged during a medical procedure. For example, a diagnostic catheter insert and an ablation diagnostic catheter insert can be interchanged during a medical procedure. During a medical procedure, the diagnostic catheter insert can be delivered to a target area through a guide sheath, and the diagnostic catheter can be connected to the guide sheath. The position of the end effector of the diagnostic catheter can be determined based on a signal from a navigation sensor on the distal portion of the guide sheath. The cardiac electrical signals of the heart can be detected by electrodes disposed on the end effector of the diagnostic catheter insert. The cardiac electrical signals can be sent to a computing system via an electrical connection between the diagnostic catheter insert and the guide sheath. The distal portion of the guide sheath can be hinged to move the end effector of the diagnostic catheter insert through the target tissue, thereby detecting electrical signals at various locations. Then, the diagnostic catheter insert can be separated from the guide sheath, and the end effector can be retracted proximally through the shaft of the guide sheath to separate the diagnostic catheter insert from the guide sheath.

[0009] During the same medical procedure, an ablation catheter inserter may be inserted into and coupled to the guide sheath. The position of the end effector of the ablation catheter inserter may be determined based on a signal from a navigation sensor on the distal portion of the guide sheath. Electrical signals for ablating tissue may be transmitted through an electrical connection between the ablation catheter inserter and the guide sheath base and transmitted to the end effector of the ablation catheter inserter. The distal portion of the guide sheath may be hinged to allow the end effector of the ablation catheter inserter to move through the target tissue, thereby ablating tissue at various locations. The ablation catheter inserter may be detachable from the guide sheath to allow additional catheter inserters to be coupled to the guide sheath as needed. The guide sheath may be further configured to accommodate other intracavitary devices, such as dilators, transseptal needles, and / or guidewires.

[0010] An exemplary system may 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 a lumen of the sheath shaft; a proximal hub coupled to the 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 cooperate with the first modular electrical port of the guide sheath to transmit 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 may include a sheath shaft, a handle, a system electrical port, and a modular electrical port. The sheath shaft extends along a longitudinal axis and has a lumen 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 connected to a proximal end of the catheter shaft; an electrode assembly connected to a distal portion of the catheter shaft; and a modular electrical port configured to cooperate with an electrical port of a guide sheath to transmit 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 inserter, and a second catheter inserter. The guide sheath includes: a sheath shaft extending along a longitudinal axis; a handle connected to the proximal end of the sheath shaft; a first modular electrical port; and a system electrical port. The first catheter inserter includes: a first catheter shaft configured to traverse the lumen of the sheath shaft; a first proximal hub connected to the proximal end of the first catheter shaft; a first electrode assembly connected to the distal portion of the first catheter shaft; and a second modular electrical port configured to cooperate with the first modular electrical port of the guide sheath to transmit electrical signals between the first electrode assembly and the system electrical port via the connection of the first modular electrical port and the second modular electrical port. The second catheter insert includes: a second catheter shaft, which is configured to traverse the lumen of the sheath shaft; a second proximal hub, which is connected to the proximal end of the second catheter shaft; a second electrode assembly, which is connected to the distal portion of the second catheter shaft; and a third modular electrical port, which is configured to cooperate with the first modular electrical port of the guide sheath to transmit electrical signals between the second electrode assembly and the system electrical port via the connection of the first electrical port and the third electrical port. BRIEF DESCRIPTION OF THE DRAWINGS

[0014] Although claims are provided after the specification which particularly point out and distinctly claim the subject matter described herein, it is believed that the subject matter will be better understood from the following description of certain examples taken in conjunction with the accompanying drawings, in which like reference numerals represent the same elements. The accompanying drawings depict one or more specific implementations of the present device by way of example only and not by way of limitation.

[0015] Figure 1A and Figure 1B is an illustration of an exemplary catheter-based electrophysiological mapping and ablation system utilizing a modular catheter system.

[0016] Figure 2 is an illustration of an exemplary modular catheter system.

[0017] Figure 3A is an illustration of a proximal portion of an exemplary catheter inserter.

[0018] Figure 3B is an illustration of a distal portion of an exemplary catheter inserter.

[0019] Figure 3C is an illustration of a distal portion of another exemplary catheter inserter.

[0020] Figure 4 is an illustration of an isometric view of a proximal portion of a modular catheter system.

[0021] Figure 5 is an illustration of components of an exemplary catheter-based electrophysiological mapping and ablation system.

[0022] Fig. 6A and Figure 6B is an illustration of an exemplary modular catheter system including a catheter inserter having an adjustable shaft length.

[0023] Figure 7 is an illustration of an exemplary pulmonary vein diagnostic and treatment kit. DETAILED DESCRIPTION

[0024] The following detailed description should be read in conjunction with the accompanying drawings, in which the same elements are labeled the same in different drawings. The accompanying drawings (not necessarily drawn to scale) depict selected embodiments and are not intended to limit the scope of the invention. The detailed description illustrates the principles of the invention by way of example and not by way of limitation. This description will clearly enable those skilled in the art to prepare and use the invention, and describes several embodiments, adaptations, variations, alternatives, and uses of the invention, including the best modes currently believed to be implemented in the invention.

[0025] In addition, as used herein, the terms "patient", "recipient", "user" and "subject" refer to any human or animal subject, and are not intended to limit the systems or methods to human use, but the use of the subject invention in human patients represents a preferred embodiment. Likewise, the term "proximal" refers to a position closer to an operator, while "distal" refers to a position farther from an operator or physician.

[0026] Alternative device and system features and alternative method steps are presented in the example embodiments herein. As will be understood by those skilled in the relevant art and as explicitly stated herein, each given example embodiment presented herein may be modified to include features and / or method steps presented with different example embodiments herein, where such features and / or steps are compatible with the given example. Such modifications and variations are intended to be included within the scope of the claims.

[0027] The systems and methods disclosed herein are configured to perform catheter-based medical procedures utilizing multiple catheter inserters.

[0028] Figure 1A and Figure 1B is an illustration of an exemplary catheter-based electrophysiological mapping and ablation system 10 utilizing a modular catheter system 100 . Figure 1A A diagnostic catheter inserter 60a is illustrated coupled to the introducer sheath 40 at a diagnostic step of a medical procedure, and Figure 1B A treatment catheter inserter 60b (also referred to herein as an ablation catheter inserter) is illustrated coupled to an introducer sheath 40 at a treatment step of a medical procedure.

[0029] During a medical procedure, the guide sheath 40 can be inserted percutaneously by the physician 24 through the patient's vascular system into a chamber or vascular structure of the heart 12. The distal portion of the guide sheath 40 can be positioned in the left atrium or right atrium near the desired location in the heart 12. Optionally, an intravascular device (such as a dilator, a transseptal needle and / or a guidewire) can be inserted into the guide sheath 40 to approach the target treatment site. Thereafter, the sheath inserts 60a, 60b can be sequentially inserted into the guide sheath 40 so that the electrode assemblies 70, 80 connected to the distal portions of the shafts of the respective catheter inserts 60a, 60b can contact tissue at or near the target treatment site. The catheter inserts 60a, 60b can be replaced as needed during the medical procedure.

[0030] Figure 1A The diagnostic catheter inserter 60a illustrated in the figure is configured to sense intracardiac electrogram (IEGM) signals. During the diagnostic step, the physician 24 brings the electrode assembly 80 of the end effector of the catheter inserter 60a into contact with the heart wall for sensing the target site in the heart 12. The electrode assembly 80 includes one and preferably a plurality of electrodes 81, which are optionally distributed on a plurality of spines 82 and are configured to sense IEGM signals.

[0031] Figure 1BThe ablation catheter insert 60b illustrated in the figure is configured to provide an electrical signal to tissue to ablate the tissue and interrupt abnormal electrical signals propagating through 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 brings the ablation electrode 71 into contact with the tissue of the heart 12 so that ablation energy can be provided to the ablation electrode 71 to ablate the tissue.

[0032] Common Reference Figure 1A and Figure 1B , 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 that is configured to provide electrical communication with a patient interface unit (PIU) 30. The patient interface unit (PIU) 30 is an interface configured to be able to establish electrical communication between a catheter, electrophysiology equipment, a power source, and a workstation 14 for controlling the operation of the system 10. The electrophysiology equipment of the system 10 may include, for example, a guide sheath 40, additional catheter inserts, a catheter, a positioning pad 25, a surface ECG electrode 18, an electrode patch 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, for performing ECG calculations, and / or for controlling electrical signals provided to perform ablation. The system 10 may also include an adapter 90 configured to provide an electrical connection between the system electrical port 45 and the PIU 30 .

[0033] During the diagnostic step ( Figure 1A ), the electrical signal sensed by the electrode 81 of the electrode assembly 80 can be sent to the PIU 30 through the conductor in the shaft of the diagnostic catheter inserter 60a, through the electrical connection between the proximal hub 64 and the handle 41, through the system electrical port 45, and through the adapter 90.

[0034] The system 10 may include an ablation energy generator 13 adapted to conduct ablation energy to one or more electrodes at the distal end of a catheter configured for ablation. The energy generated by the ablation energy generator 13 may include, but is not limited to, radio frequency (RF) energy or pulsed field ablation (PFA) energy (including monopolar or bipolar high voltage DC pulses that can be used to achieve irreversible electroporation (IRE)), or a combination thereof.

[0035] During the ablation step ( Figure 1B), an electrical signal may 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 a conductor in the shaft of the ablation catheter insert 60b to the electrode 71 of the electrode assembly 70, and to the target tissue.

[0036] Common Reference Figure 1A and Figure 1B , the guide sheath 40 includes a navigation sensor 50, which is coupled to the distal portion of the sheath shaft 42. The navigation sensor 50 is configured to track the position and orientation of the distal portion of the catheter inserts 60a, 60b including the corresponding electrode assemblies 70, 80. The navigation sensor 50 is preferably a magnetic-based position sensor, which includes three magnetic coils for sensing three-dimensional (3D) position and orientation. The magnetic-based position sensor 50 can operate with a positioning pad 25, which includes a plurality of magnetic coils 32 configured to generate a magnetic field in a predefined working space. The real-time position of the distal portion of the corresponding catheter inserts 60a, 60b can be tracked based on the magnetic field generated by the positioning pad 25 and sensed by the magnetic-based position sensor 50. Details of magnetic-based position sensing techniques are described in U.S. Patent 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.

[0037] 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 illustrated, the electrode 49 may be configured as a ring electrode. The system 10 includes one or more electrode patches 38 positioned to contact the skin of the patient 23 to establish a position reference for impedance-based tracking of the positioning pad 25 and the electrode 49. For impedance-based tracking, current is directed toward the electrode 49 and sensed at the electrode skin patch 38 so that the position of each electrode can be triangulated via the electrode patch 38. The details of impedance-based position tracking technology are described in U.S. Patents 7,536,218, 7,756,576, 7,848,787, 7,869,865 and 8,456,182, which are incorporated herein by reference.

[0038] The size, shape and other configuration of the catheter inserts 60a, 60b and the guide sheath 40 can be set so that when the proximal hub 64 of the respective catheter inserts 60a, 60b is connected to the handle 41 of the guide sheath 40, the respective distal portions of the catheter inserts 60a, 60b are in a predetermined position (or approximately a predetermined position) relative to the navigation sensor 50 (and optionally the electrode 49). The PIU 30 can be configured to determine the position of the distal portions of the catheter inserts 60a, 60b (and the electrodes 71, 81 of the electrode assemblies 70, 80 of the respective catheter inserts 60a, 60b) based at least in part on the position of the distal portion of the sheath shaft 42. The navigation sensor 50 of the sheath shaft is configured to provide an indication of the position of the distal portions of the catheter inserts 60a, 60b.

[0039] Optionally, the electrodes 71, 81 of the respective catheter inserts 60a, 60b can be used for impedance-based position tracking of the respective electrode assemblies 70, 80. For example, the electrode assemblies can include flexible features that can be configured to move relative to the navigation sensor 50 (and optionally the electrodes 49 on the sheath shaft 42) within a predetermined space, and impedance-based position tracking can be used to determine the position of the electrodes within the predetermined space. In particular, Figure 1A The electrode assembly 80 illustrated in the figure includes an electrode 81 connected 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 is capable of moving in 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 navigation sensor 50 (and optionally the electrode 49 on the sheath shaft 42), and thus the predetermined space in which the flexible spine 82 can move is in a predetermined position relative to the navigation sensor 50 (and optionally the electrode 49 on the sheath shaft 42). The electrodes 81 on the spine 82 can be positioned using impedance-based tracking to provide more precise positioning of each electrode 81 in the predetermined space.

[0040] Because the position of the distal portion of the respective 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 insert 60a, 60b does not need to include a navigation sensor. Preferably, the distal portion of the catheter shaft insert 60a, 60b is free of an inductive navigation sensor.

[0041] As an alternative form of the illustrated configuration, catheter insert 60a, 60b may include an inductive navigation sensor. In such examples, the distal end of sheath shaft 42 may be determined at least in part based on the inductive navigation sensor of catheter insert 60a, 60a, and sheath shaft 42 does not need to include illustrated guide sensor 50. The size, shape of catheter insert 60a, 60b and guide sheath 40 may be set and otherwise configured to make when the proximal hub 64 of corresponding catheter insert 60a, 60b is connected to the handle 41 of guide sheath 40, the corresponding distal portion of catheter insert 60a, 60b is in a predetermined position (or approximate predetermined position) relative to the inductive navigation sensor of catheter insert. As another alternative form, guide sheath shaft 42 and catheter insert 60a, 60b both may include corresponding inductive navigation sensor.

[0042] The workstation 14 includes a memory, a processor unit with a memory or storage device loaded with appropriate operating software, and a user interface capability. The workstation 14 can be configured to provide a variety of functions, optionally including: (1) three-dimensional (3D) modeling of the endocardial anatomy and rendering the model or anatomical map 20 for display on the display device 27; (2) displaying on the display device 27 an activation sequence (or other data) compiled from a recorded electrogram 21 as representative visual markers or images superimposed on the rendered anatomical map 20; (3) displaying the real-time position and orientation of the distal portion of the catheter-based device within the heart chamber; and (4) displaying on the display device 27 a site of interest, such as where ablation energy is applied. A commercial product embodying elements of the system 10 may be a CARTO TM 3 system is available from Biosense Webster, Inc., 31A Technology Drive, Irvine, CA 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 to provide sheath visualization 16 indicating the real-time position and orientation of the distal portion of the sheath shaft 42.

[0043] Recorder 11 displays electrograms 21 captured using body surface ECG electrodes 18 and intracardiac electrograms (IEGMs) captured using electrodes 26 of catheter 14. Recorder 11 may include pacing capabilities for pacing the cardiac rhythm and / or may be electrically connected to a separate pacemaker.

[0044] The system 10 may also include an irrigation system 15 configured to provide irrigation fluid to the guide sheath 40 and / or the catheter inserts 60a, 60b. The handle 41 of the guide sheath 40 may be connected to the irrigation system 15 via an irrigation line 19. Figure 1BAs illustrated, the proximal hub 64 of the ablation catheter inserter 60b may be connected to the irrigation system 15 via the irrigation line 22. The modular system 100 may be configured such that irrigation fluid may be provided to the lumen of the guide sheath independently of irrigation provided to the ablation catheter inserter 60b.

[0045] The system 10 may also include an implant and an implant delivery system (not illustrated). For example, a left atrial appendage occlusion (LAAO) device and associated delivery system or other such vascular or cardiac implants and delivery systems as understood by those skilled in the relevant art. The implant can be delivered to the treatment site through the guide sheath 40 using the implant delivery system. The navigation sensor 50 can be used to determine the position of the distal end 48 of the sheath. The implant can be inserted into the hemostatic valve 51 of the guide sheath 40, manipulated by the implant delivery system to push the implant distally through the sheath shaft 42, and discharged from the distal end 48 of the guide sheath 40 at the treatment site. The implant can then be deployed and the delivery system can be retracted proximally from the guide sheath 40.

[0046] Figure 2 is an illustration of an exemplary modular catheter system 100 including an introducer sheath 40 and a catheter inserter 60. The modular catheter system 100 is as described with respect to Figure 1A and Figure 1B The ablation catheter inserter is configured as described and illustrated as including an ablation catheter inserter similar to Figure 1B The illustrated ablation catheter inserter 60b is configured. 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 Figure 1A and Figure 1B The annular electrode 49 is configured as disclosed. The catheter inserter 60 includes a proximal hub 60 and a Figure 1B The modular catheter system 100 may also include a diagnostic catheter inserter 60, which includes an electrode assembly 70 configured as disclosed. Figure 1A An electrode assembly 80 configured as disclosed may be interchangeable with the illustrated catheter inserter 60 .

[0047] The guide sheath 40 includes a first modular electrical port 46, and the catheter inserter 60 includes a second modular electrical port 61, which is configured to cooperate with the first modular electrical port 46 to transmit electrical signals between the electrode assembly 70 and the system electrical port 45. The first modular electrical port 46 and the second modular electrical port 61 can be further configured to be mechanically coupled to each other, thereby fixing the position of the proximal hub 64 relative to the sheath handle 41. In order to couple the guide sheath 40 to the catheter inserter 60, the distal end 72 of the sheath inserter 60 is inserted into the opening in the hemostatic valve 51 at the proximal end of the sheath handle 41, and the shaft 62 of the catheter inserter 60 is pushed distally through the sheath shaft 47. Then, the second modular electrical port 61 of the catheter inserter 60 is inserted into the first modular electrical port 46 of the guide sheath 40. Once coupled, the distal portion of the catheter inserter 60 (including the electrode assembly 70) extends a predetermined length from the distal end 48 of the sheath shaft 47.

[0048] The sheath shaft 42 extends along the longitudinal axis AA. The sheath shaft 42 may be configured to deflect from the longitudinal axis, as illustrated. The sheath handle 41 may include a deflection knob 43, which is configured to be manipulated to deflect the distal portion of the sheath shaft 42 and the distal portion of the catheter shaft 62 from the longitudinal axis. The modular catheter system 100 may be configured so that the distal portion of the catheter shaft 62 cannot be deflected independently of the guide sheath 40. The catheter insert 60 may not have a mechanism (e.g., a pull wire) for deflecting the distal portion of the catheter shaft from the longitudinal axis AA, and the deflection of the sheath shaft 42 alone may be sufficient to position the electrode assembly 70 at a desired position during a medical procedure.

[0049] The guide sheath 40 may also include an irrigation port 44 configured to be coupled to an irrigation system 15 ( Figure 1A and Figure 1B The catheter insert 60 may also include an irrigation port 63 configured to be coupled to an irrigation system 15 ( Figure 1A and Figure 1B ).

[0050] The catheter insert 60 need not include a navigation sensor and associated electrical conductors passing through the catheter shaft 62, and the catheter insert 60 need not include a deflection mechanism (such as a pull wire). Therefore, the catheter insert 60 can be manufactured less expensively and / or with a smaller French size than a corresponding diagnostic or therapeutic catheter configured with independent navigation and / or deflection. The reduced French size of the catheter insert 60 can further result in a smaller outer diameter of the guide sheath 40 than similar guide sheaths known in the art, resulting in easier intravenous translation and a smaller incision size.

[0051] In addition, the guide sheath 40 and the catheter inserter 60 can be more easily manipulated by the physician 23 than similar systems that include separate guide sheaths and catheters. When coupled, the proximal hub 64 can essentially serve as an extension of the guide sheath handle 41, so that only one handle is to be manipulated, rather than using two handles in existing procedures. The electrical connection between the guide sheath 40 and the catheter inserter allows a single cable to provide an electrical connection to the PIU 30, thereby reducing the potential entanglement of cables compared to systems with separate cables for the guide sheath and catheter.

[0052] Figure 3A 6 is an illustration of a proximal portion of an exemplary catheter inserter 60 showing a proximal hub 64, a second modular electrical port 61, and a proximal portion of a catheter shaft 62. As illustrated, the catheter inserter 60 also includes an optional flushing port 63.

[0053] Figure 3B is an illustration of a distal portion of an exemplary ablation catheter inserter 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 inserter preferably includes an irrigation port 63 ( Figure 3A ). The ablation catheter inserter may include a variety of end effector configurations, including balloon, basket, ray, grid, and other suitable electrode arrangements as understood by those skilled in the relevant art.

[0054] Figure 3C is an illustration of a distal portion of an exemplary diagnostic catheter inserter including an electrode assembly 80 having an electrode 81 configured to sense an IEGM signal. The diagnostic catheter may not require flushing and therefore may not have a flush port 63 ( Figure 3A ). The diagnostic catheter inserter may include a variety of end effector configurations, including balloon, basket, ray, grid, and other suitable electrode arrangements as understood by those skilled in the relevant art.

[0055] As another example, the catheter inserter 60 can be configured to perform visualization of the treatment area. For example, the visualization catheter inserter can include an ultrasound probe near the distal end of the visualization catheter. The distal portion of such a visualization catheter inserter can be determined as generally described with respect to the catheter inserter 60.

[0056] Figure 4 is an illustration of an isometric view of the modular catheter system 100. The shaft 62 of the catheter inserter 60 has been inserted into the proximal end of the hemostasis valve 51 of the guide sheath 40. The catheter inserter 60 is movable in the distal end direction relative to the guide sheath 40 to mate the second modular electrical port 61 of the catheter inserter 60 to the first modular electrical port 46 of the guide sheath 40.

[0057] Figure 5 is similar to Figure 1A and Figure 1B Illustration of components of an exemplary catheter-based electrophysiological mapping and ablation system configured with the disclosed system 10. Adapter 90 includes a sheath electrical connector 91, a shunt 92, a diagnostic electrode connector 93, a mapping connector 94, and an ablation generator connector 95. Sheath electrical connector 91 is configured to electrically connect to system electrical port 45 of guide sheath 40. Diagnostic electrode connector 93 is configured to send electrical signals from an electrode assembly of a diagnostic catheter insert to PIU 30. Mapping connector 94 is configured to electrically connect navigation sensor 50 (and optionally electrode 49) to PIU 30. Ablation generator connector 95 is configured to electrically connect ablation electrode 71 to PIU 30. Shunt 92 is configured to route electrical signals between a single sheath electrical connector 91 and three PIU electrical connectors 93, 94, 95.

[0058] Fig. 6A and Figure 6B is an illustration of an exemplary assembly that includes a guide sheath 40 and a catheter inserter 60 having an adjustable shaft length. The proximal hub 64 of the catheter inserter 60 includes an extension rod 65 that is configured to move the catheter shaft 62 proximally and distally by a length L1 so that the catheter shaft 62 can extend and retract the length L1 from the distal end 48 of the guide sheath 40. The proximal hub 64 may be further configured with an electrical sensor that is electrically connected to the second modular electrical port 61, and the electrical sensor may be configured to provide an electrical signal indicating the length by which the distal portion of the catheter inserter 60 extends from the distal end 48 of the guide sheath 40. The electrical sensor may be electrically connected to the second modular electrical port 61 ( Figure 4 ) so that it can be electrically coupled to a computing system (such as a workstation 13 or a PIU 30 ( Figure 1A and Figure 1B )). The computing system may be configured to determine the position of the electrode assembly 70 of the catheter inserter 60 based at least in part on the extended length of the distal portion of the catheter inserter 60. As will be appreciated by those skilled in the relevant art, the illustrated electrode assembly 70 may have an end effector design similar to existing ablation catheters and / or diagnostic catheters, their alternative forms, and their variations (including those not yet developed).

[0059] Figure 7is an illustration of an exemplary pulmonary vein diagnostic and therapeutic kit 101. Kit 101 includes an introducer sheath 40, a diagnostic catheter insert 60a, and a therapeutic catheter insert 60b, which are configured as disclosed elsewhere herein. The therapeutic kit 101 may also include accessories, such as a dilator 33 and a guidewire 34 (illustrated in a guidewire sheath 35).

[0060] The following clauses set forth non-limiting embodiments of the present disclosure:

[0061] Item 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 connected to the proximal end of the sheath shaft; a first modular electrical port; and a system electrical port; and the catheter insert comprising: a catheter shaft configured to traverse a lumen of the sheath shaft; a proximal hub connected to the proximal end of the catheter shaft; an electrode assembly connected to a distal portion of the catheter shaft; and a second modular electrical port configured to cooperate with the first modular electrical port of the guide sheath to transmit 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.

[0062] Clause 2. The system of clause 1, the guide sheath comprising a navigation sensor coupled to a distal portion of the sheath shaft and electrically connected to the system electrical port.

[0063] Clause 3. The system of Clause 2, the navigation sensor configured to provide an indication of a position of the distal portion of the catheter inserter.

[0064] Clause 4. The system of any one of clauses 1 to 3, wherein the distal portion of the catheter shaft is devoid of an inductive navigation sensor.

[0065] Clause 5. The system of any one of clauses 1 to 4, the handle of the introducer sheath comprising a deflection knob configured to be manipulated to deflect distal portions of the sheath shaft and the catheter shaft from the longitudinal axis.

[0066] Clause 6. The system of any one of Clauses 1 to 5, wherein the catheter inserter is devoid of a mechanism for deflecting a distal portion of the catheter shaft.

[0067] Clause 7. The system of any one of Clauses 1 to 6, wherein the distal portion of the catheter shaft is not deflectable independently of the guide sheath.

[0068] Clause 8. A system according to any one of clauses 1 to 7, wherein the first modular electrical port of the sheath insert is connected to the handle of the guide sheath, wherein the second modular electrical port of the catheter insert is connected to the proximal hub of the catheter insert, and wherein the first modular electrical port and the second modular electrical port are configured to be mechanically coupled to each other to fix the position of the hub relative to the handle.

[0069] Clause 9. The system of any one of clauses 1 to 8, the handle comprising a hemostasis valve configured to receive the catheter shaft.

[0070] Clause 10. The system of any of Clauses 1 to 9, the introducer sheath further comprising a flush port fluidly coupled to the lumen of the sheath shaft.

[0071] Clause 11. The system of any of Clauses 1 to 10, the electrode assembly comprising one or more ablation electrodes configured to ablate cardiac tissue.

[0072] Clause 12. The system of Clause 11, wherein the one or more ablation electrodes are configured to ablate cardiac tissue using radiofrequency ablation electrical signals and / or pulsed field ablation electrical signals.

[0073] Clause 13. The system of any of clauses 1 to 12, the introducer sheath configured to provide cardiac ablation electrical signals from the system electrical port to the first modular electrical port.

[0074] Clause 14. The system of any one of clauses 1 to 13, further comprising: an ablation generator configured to connect to the system electrical port and provide a cardiac ablation electrical signal to the electrode assembly via a connection between the first modular electrical port and the second modular electrical port.

[0075] Clause 15. The system of any of Clauses 1 to 14, the catheter inserter further comprising a flush port coupled to the proximal hub of the catheter inserter and configured to provide flushing fluid to the distal portion of the catheter shaft.

[0076] Clause 16. The system of any one of Clauses 1 to 15, wherein the electrode assembly is configured to sense cardiac electrical signals from cardiac tissue.

[0077] Clause 17. The system of any one of Clauses 1 to 16, the electrode assembly comprising a plurality of diagnostic electrodes configured to sense cardiac electrical signals from cardiac tissue.

[0078] Clause 18. According to the system of clause 17, the electrode assembly includes a plurality of ridges, the plurality of ridges are configured to transition through the lumen of the guide sheath in a collapsed configuration aligned with the longitudinal axis, and are configured to expand away from the longitudinal axis when leaving the distal end of the guide sheath, and the plurality of diagnostic electrodes are connected to the plurality of ridges.

[0079] Clause 19. The system of any of clauses 16 to 18, the introducer sheath configured to receive the cardiac electrical signal at the first modular electrical port and to transmit the cardiac electrical signal to the system electrical port.

[0080] Clause 20. A system according to any one of clauses 1 to 10, the system comprising a first catheter insert and a second catheter insert, the first catheter insert comprising the catheter insert, the second catheter insert comprising: a second catheter shaft, the second catheter shaft being configured to traverse the lumen of the sheath shaft; a second proximal hub, the second proximal hub being connected to the proximal end of the second catheter shaft; a second electrode assembly, the second electrode assembly being connected to the distal portion of the second catheter shaft; and a third modular electrical port, the third modular electrical port being configured to cooperate with the first modular electrical port of the guide sheath to transmit electrical signals between the second electrode assembly and the system electrical port via the connection of the first modular electrical port and the third modular electrical port, and the second electrode assembly comprising an electrode configuration different from the electrode configuration of the electrode assembly of the first catheter insert.

[0081] Clause 21. The system of Clause 20, the electrode assembly of the first catheter insertion piece being configured to ablate cardiac tissue, and the second electrode assembly of the second catheter insertion piece being configured to sense cardiac electrical signals from cardiac tissue.

[0082] Clause 22. A system according to any one of clauses 1 to 21, wherein the system includes an adapter configured to electrically connect the system electrical port to a computing system and an ablation generator, the computing system being configured to receive cardiac electrical signals from cardiac tissue via the adapter, and the ablation generator being configured to provide ablation electrical signals via the adapter.

[0083] Clause 23. According to the system of clause 22, the guide sheath includes a navigation sensor, which is connected to the distal portion of the sheath shaft and is electrically connected to the system electrical port, and the computing system is configured to determine the 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.

[0084] 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 a treatment site through the introducer sheath.

[0085] Item 25. A guide sheath comprising: a sheath shaft extending along a longitudinal axis and comprising a lumen 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.

[0086] 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.

[0087] Clause 27. The guide sheath of Clause 26, the navigation sensor configured to provide an indication of a position of the electrode coupled to the catheter shaft.

[0088] Clause 28. The introducer sheath of any of Clauses 25 to 27, the handle comprising a deflection knob configured to be manipulated to deflect a distal portion of the sheath shaft from the longitudinal axis.

[0089] Clause 29. The introducer sheath of any one of clauses 25 to 28, the handle comprising a hemostatic valve configured to receive the catheter shaft.

[0090] Clause 30. The introducer sheath of any of Clauses 25 to 29, further comprising: a flush port fluidly coupled to the lumen.

[0091] Clause 331. The guide sheath of any one of Clauses 25 to 30, further comprising: an electrical connection between the system electrical port and the modular electrical port, the electrical connection configured to transmit a cardiac ablation electrical signal from the system electrical port to the modular electrical port.

[0092] Clause 32. The introducer sheath of any one of clauses 25 to 31, further comprising: an electrical connection between the system electrical port and the modular electrical port, the electrical connection configured to transmit cardiac electrical signals from the modular electrical port to the system electrical port.

[0093] Clause 33. A guide sheath as described in any 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 be electrically connected to a first electrode assembly of a first catheter inserter, disconnected from the first electrode assembly of the first catheter inserter, and connected to a second electrode assembly of a second catheter inserter.

[0094] Item 34. A catheter insert, comprising: a catheter shaft extending along a longitudinal axis; a proximal hub connected to a proximal end of the catheter shaft; an electrode assembly connected to a distal portion of the catheter shaft; and a modular electrical port configured to cooperate with an electrical port of a guide sheath to transmit electrical signals between the electrode assembly and the electrical port of the guide sheath.

[0095] Clause 35. The catheter inserter of Clause 34, wherein the distal portion of the catheter shaft is devoid of a navigation sensor.

[0096] Clause 36. The catheter inserter of Clause 34 or 35, wherein the catheter inserter lacks a mechanism for deflecting a distal portion of the catheter shaft.

[0097] Clause 37. The catheter inserter of any of Clauses 34 to 36, the electrode assembly comprising one or more ablation electrodes configured to ablate cardiac tissue.

[0098] Clause 38. The catheter inserter of Clause 37, the one or more ablation electrodes configured to ablate cardiac tissue using radiofrequency ablation electrical signals and / or pulsed field ablation electrical signals.

[0099] Clause 39. The catheter inserter of any of Clauses 34 to 38, further comprising: a flush port coupled to the proximal hub and configured to provide flushing fluid to a distal portion of the catheter shaft.

[0100] Clause 40. The catheter inserter of any of Clauses 34 to 39, the electrode assembly configured to sense cardiac electrical signals from cardiac tissue.

[0101] Clause 41. The catheter inserter of any of Clauses 34 to 40, the electrode assembly comprising a plurality of diagnostic electrodes configured to sense cardiac electrical signals from cardiac tissue.

[0102] Clause 42. The catheter insert of clause 41, wherein the electrode assembly comprises a plurality of ridges configured to transition through the lumen of the guide sheath in a collapsed configuration aligned with the longitudinal axis and configured to expand away from the longitudinal axis upon exiting the distal end of the guide sheath, the plurality of diagnostic electrodes being coupled to the plurality of ridges.

[0103] Item 43. A pulmonary vein diagnostic and treatment kit, the pulmonary vein diagnostic and treatment kit comprising a guide sheath, a first catheter inserter and a second catheter inserter, the guide sheath comprising: a sheath shaft extending along a longitudinal axis; a handle connected to the proximal end of the sheath shaft; a first modular electrical port; and a system electrical port; the first catheter inserter comprising: a first catheter shaft configured to traverse the lumen of the sheath shaft; a first proximal hub connected to the proximal end of the first catheter shaft; a first electrode assembly connected to the distal portion of the first catheter shaft; and a second modular electrical port configured to interface with the first modular electrical port of the guide sheath. The gas port cooperates to transmit electrical signals between the first electrode assembly and the system electrical port via the connection of the first modular electrical port and the second modular electrical port; and the second catheter insert includes: a second catheter shaft, the second catheter shaft is configured to cross the tubular cavity of the sheath shaft; a second proximal hub, the second proximal hub is connected to the proximal end of the second catheter shaft; a second electrode assembly, the second electrode assembly is connected to the distal portion of the second catheter shaft; and a third modular electrical port, the third modular electrical port is configured to cooperate with the first modular electrical port of the guide sheath to transmit electrical signals between the second electrode assembly and the system electrical port via the connection of the first electrical port and the second electrical port.

[0104] 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 wherein the connection between the first modular electrical port and the second modular electrical port is configured to transmit an ablation electrical signal from the system port to the first electrode assembly.

[0105] 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 cardiac tissue, and wherein the connection between the first modular electrical port and the third modular electrical port is configured to transmit the sensed electrical signals from the second electrode assembly to the system port.

[0106] Clause 46. The pulmonary vein diagnostic and treatment kit of any one of clauses 42 to 43, further comprising: a dilator configured to traverse the lumen of the guide sheath; and a needle configured to traverse the lumen of the dilator.

[0107] Clause 47. A method for performing pulmonary vein isolation, the method comprising: positioning a distal portion of a guide sheath proximate to target tissue in the heart; inserting a distal portion of a diagnostic catheter insert into the shaft of the guide sheath; extending the distal portion of the catheter insert from the distal end of the guide sheath; connecting 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 connected to the distal portion of the guide sheath; sensing a cardiac signal using an electrode array of the distal portion of the diagnostic catheter; and separating the proximal hub of the diagnostic catheter insert from the guide sheath. ; removing the distal portion of the diagnostic catheter inserter from the shaft of the guide sheath; inserting the distal portion of the ablation catheter into the shaft of the guide sheath; connecting the proximal hub of the ablation catheter inserter to the guide sheath; determining the position of the distal portion of the ablation catheter based at least in part on electrical signals from the navigation sensor connected to the distal portion of the guide sheath; applying ablation energy to the target tissue using the electrode array of the distal portion of the ablation catheter inserter; separating the proximal hub of the ablation catheter inserter from the guide sheath; and removing the distal portion of the ablation catheter inserter from the shaft of the guide sheath.

[0108] Clause 48. A method according to clause 47, wherein the guide sheath, the diagnostic catheter insert and the ablation catheter insert each include a corresponding modular electrical port, wherein connecting the proximal hub of the diagnostic catheter insert to the guide sheath includes: mating the modular electrical port of the guide sheath to the modular electrical port of the diagnostic catheter insert, wherein sensing a cardiac signal using the electrode array of the distal portion of the diagnostic catheter signal includes: sending the cardiac electrical signal through the connection between the modular electrical port of the guide sheath and the modular electrical port of the diagnostic catheter, wherein connecting the proximal hub of the ablation catheter insert to the guide sheath includes: mating the modular electrical port of the guide sheath to the modular electrical port of the ablation catheter insert, and wherein applying ablation energy to the target tissue using the electrode array of the distal portion of the ablation catheter insert includes: delivering an electrical signal through the connection between the modular electrical port of the guide sheath and the modular electrical port of the ablation catheter insert.

[0109] Clause 49. The method of clause 47 or 48, comprising flushing the ablation catheter and flushing the guide sheath independently of each other.

[0110] Exemplary embodiments of the subject matter contained herein have been shown and described, and further improvements 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 portion of the illustrated catheter inserts 60, 60a, 60b may have various alternative end effector configurations, including saccular, basket-shaped, ray-shaped, grid-shaped, and other suitable electrode arrangements understood by those skilled in the relevant art. As understood by those skilled in the relevant art, the illustrated electrode assemblies 70, 80 may have various alternative end effector designs that may be similar to existing ablation catheters and / or diagnostic catheters, their alternative forms, and their variations, including those that have not yet been developed.

[0111] In addition, where the above methods and steps represent specific events that occur in a specific order, it is intended that certain specific steps do not necessarily have to be performed in the order described, but can be performed in any order as long as the steps enable the embodiment to achieve its intended purpose. Therefore, if there are variations of the present invention and these variations fall within the substantive scope of the present disclosure or equivalents that can be found in the claims, then this patent is intended to cover these variations as well. Many such modifications will be apparent to those skilled in the art. For example, the examples, embodiments, geometries, materials, dimensions, ratios, steps, etc. described above are all illustrative. Therefore, the claims should not be limited to the specific details of the structure and operation shown in this written description and the drawings.

Claims

1. A system, comprising: A guide sheath, the guide sheath comprising: a sheath shaft extending along a longitudinal axis; a handle coupled to the proximal end of the sheath shaft; a first modular electrical port; and System electrical ports; and A catheter inserter, the catheter inserter comprising: a catheter shaft configured to traverse the 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 is configured to mate with the first modular electrical port of the guide sheath to transmit electrical signals between the electrode assembly and the system electrical port via connection of the first modular electrical port and the second modular electrical port.

2. The system of claim 1, the guide sheath comprising 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, the navigation sensor being configured to provide an indication of the position of the distal portion of the catheter inserter.

4. The system of claim 1, the handle of the introducer sheath comprising a deflection knob configured to be manipulated to deflect distal portions of the sheath shaft and the catheter shaft from the longitudinal axis.

5. The system according to claim 1, wherein: The distal portion of the catheter shaft is not deflectable independently of the introducer sheath.

6. The system according to claim 1, in, the first modular electrical port of the guide sheath being coupled to the handle of the guide sheath, wherein the second modular electrical port of the catheter inserter is coupled to the proximal hub of the catheter inserter, and Wherein, the first modular electrical port and the second modular electrical port are configured to be mechanically coupled to each other to fix the position of the proximal hub relative to the handle.

7. The system of claim 1, the handle comprising a hemostatic valve configured to receive the catheter shaft.

8. The system of claim 1, the introducer sheath further comprising a flush port fluidly coupled to the lumen of the sheath shaft.

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

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

11. The system of claim 1, the introducer sheath configured to provide cardiac ablation electrical signals from the system electrical port to the first modular electrical port.

12. The system of claim 1, the catheter inserter further comprising a flush port coupled to the proximal hub of the catheter inserter and configured to provide flushing 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, the electrode assembly comprising a plurality of diagnostic electrodes configured to sense cardiac electrical signals from cardiac tissue.

15. A system according to claim 14, the electrode assembly includes a plurality of ridges, the plurality of ridges being configured to transition through the lumen of the guide sheath in a collapsed configuration aligned with the longitudinal axis and being configured to expand away from the longitudinal axis when leaving the distal end of the guide sheath, the plurality of diagnostic electrodes being connected to the plurality of ridges.

16. The system of claim 13, the introducer sheath 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. The system of claim 1, comprising a first catheter inserter and a second catheter inserter, the first catheter inserter comprising the catheter inserter, The second catheter insert comprises: a second catheter shaft configured to traverse 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, wherein the third modular electrical port is configured to cooperate with the first modular electrical port of the guide sheath to transmit electrical signals between the second electrode assembly and the system electrical port via a connection between the first modular electrical port and the third modular electrical port, and the second electrode assembly includes an electrode configuration different from the electrode configuration of the electrode assembly of the first catheter inserter.

18. The system according to claim 17, The electrode assembly of the first catheter inserter is configured to ablate cardiac tissue, and The second electrode assembly of the second catheter inserter is configured to sense cardiac electrical signals from cardiac tissue.

19. The system of claim 1, 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 cardiac tissue via the adapter, and the ablation generator configured to provide ablation electrical signals via the adapter, The guide sheath includes a navigation sensor coupled to a distal portion of the sheath shaft and 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 navigation electrical signals received from the navigation sensor via the adapter.

20. The system of claim 1, further comprising: Implants; and An implant delivery system is configured to deliver the implant to a treatment site through the introducer sheath.

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