Medical system with catheter and introducer

Abstract

The invention refers to a catheter (1a) for use in a medical system (1) comprising the catheter and an introducer (1b) that can be easily operated by an HCP and, at the same time, provides high accuracy and minimal treatment time. The catheter comprises a catheter handle (12) at its proximal end and an elongated catheter shaft (4) extending distally from the catheter handle, wherein the introducer comprises an introducer handle (8) at its proximal end and a tubular introducer sheath (2) extending distally from the introducer handle and along a longitudinal axis, wherein the introducer handle comprises an inner lumen with transseptal port configured to guide the catheter shaft through the introducer handle and into the introducer sheath, wherein the catheter handle comprises a coupling assembly (13) at its distal end, wherein the coupling assembly is configured to releasably couple the catheter handle (12) to the introducer handle (8) so as to prevent movement of the catheter with respect to the introducer along the longitudinal axis after the catheter shaft is introduced through the transseptal port into the introducer handle and the introducer sheath and to allow manual and / or gear driven rotation of the catheter shaft (4) into one pre-defined direction of rotation (arrow 75). The invention further refers to a corresponding introducer, a corresponding coupling assembly, and a corresponding medical system (1).

Description

[0001] Applicant: VascoMed GmbH

[0002] Date: 23.09.2025

[0003] Our Reference: 23.168P-WO

[0004] MEDICAL SYSTEM WITH CATHETER AND INTRODUCER

[0005] The invention relates to a medical system comprising a catheter and an introducer.

[0006] Catheters are medical devices with a broad range of functions. In many cases they comprise a handle at its proximal end and an elongated catheter shaft extending distally from this handle. Catheters may be inserted into a body cavity, duct, vessel, brain, skin or adipose tissue. They allow treatment and / or examination / mapping of a patient’s tissue or bodily fluid, for example by means of an electrical field. Additionally, or alternatively, catheters may be used to deliver and / or retrieve an implant to / from a target location of the patient’s body. One example for a catheter using an electrical field is an ablation catheter that may be used for performing cardiac ablation procedures, such as, but not limited to, pulmonary vein isolation (PVI), persistent atrial fibrillation ablation, or ventricular tachycardiac ablation.

[0007] PVI has been used as a treatment of atrial fibrillation which is the most common supraventricular arrhythmia with increasing incidence and prevalence. Until now, thermal energy sources, e.g. radiofrequency or cryoablation, have been used for interventional treatment as part of PVI, but these not only destroy myocytes but also neighboring tissue. In contrast, pulsed field ablation (PF A) is a form of energy that does not utilize thermal effects. An irreversible change in the cell membrane pores (irreversible electroporation) occurs by application of an electric pulse for some micro-seconds. Compared to the oesophagus, the pulmonary veins (PVs) or the phrenic nerve, the myocardium reacts very sensitively to this form of energy release. Consequently, it is possible to effectively ablate PVs in a very short time without damaging adjacent tissue (see Lindemann F et al, “Pulmonary vein isolation in atrial fibrillation using pulsed field ablation”, HERZ 4 / 2021). For PFA treatment, the catheter usually comprises PFA electrodes designed in such way that the electrodes generate pulsed electric fields with very high voltages of several thousand volts. In such procedures, the PVs are electrically isolated from the left atrium by creating contiguous circumferential ablation lesions around the pulmonary vein ostium (PVO) or around its antrum, for example by PF A. Thus, irregular atrial contractions can be avoided by hindering undesired perturbing electrical signals generated within the PV from propagating into the left atrium. Catheters providing an electrical field, e.g., for ablation may be used to deliver therapy or diagnosis to other tissues, such as, but not limited to: ventricles, right atrium, the body of the left atrium. Additionally, other organs may be treated by using such catheters: lungs, liver, kidneys, etc.

[0008] To control treatment the catheter may provide additional (ring) electrodes for electrical signal detection from the treated tissue of the patient, e.g. for recording an intracardiac electrogram (IEGM), or for application of pacing signals. For precise and suitable treatment and treatment control, the PFA electrodes and, if applicable, the additional (ring) electrodes are often located at a distal active portion of the catheter shaft formed, e.g. as loop. For application, the catheter is guided within a suitable transseptal introducer comprising a steerable tubular introducer sheath already inserted into the patient’ s vessel to be treated, e.g. the heart. The introducer may provide the deflection for proper positioning of the active portion. During PFA treatment, the active section may be rotated around a center point to create a closed circular ablation line that electrophysiologically isolates the inner heart wall tissue from the outer tissue.

[0009] The introducer and catheter control aiming at precise positioning and / or deflection of the active portion of the catheter at a pre-defined treatment location and time-consuming rotational movement of the catheter’s active portion during treatment turns out to be quite complicated for the health care practitioner (HCP), in particular since the HCP has to operate both, the introducer and the catheter simultaneously.

[0010] Accordingly, it is an object of the invention is to provide a medical system comprising the catheter and the introducer that can be easily operated by an HCP and, at the same time, provides high accuracy and minimal treatment time.

[0011] The above object is solved by a catheter for use in a medical system comprising the catheter and an introducer with the features of claim 1, similarly by an introducer for use in such

[0012] 23.168P-WO | 23.09.2025 medical system with the features of claim 2, similarly by a coupling assembly for use in such medical system having the features of claim 3 and by a medical system with the features of claim 15.

[0013] In particular, the above object is solved by catheter for use in a medical system comprising the catheter and an introducer, wherein the catheter comprises a catheter handle at its proximal end and an elongated catheter shaft extending distally from the catheter handle, wherein the introducer comprises an introducer handle at its proximal end and a tubular introducer sheath extending distally from the introducer handle and along a longitudinal axis, wherein the introducer handle comprises an inner lumen with transseptal port configured to guide the catheter shaft through the introducer handle and into the introducer sheath, wherein the catheter handle comprises a coupling assembly at its distal end, wherein the coupling assembly is configured to releasably couple the catheter handle to the introducer handle so as to prevent movement of the catheter with respect to the introducer along the longitudinal axis after the catheter shaft is introduced through the transseptal port into the introducer handle and the introducer sheath and to allow manual and / or gear driven rotation of the catheter shaft into one pre-defined direction of rotation.

[0014] Further in particular, the above object is solved by an introducer for use in a medical system comprising a catheter and the introducer, wherein the catheter comprises a catheter handle at its proximal end and an elongated catheter shaft extending distally from the catheter handle, wherein the introducer comprises an introducer handle at its proximal end and a tubular introducer sheath extending distally from the introducer handle and along a longitudinal axis, wherein the introducer handle comprises an inner lumen with transseptal port configured to guide the catheter shaft through the introducer handle and into the introducer sheath, wherein the introducer handle comprises a coupling assembly at its proximal end, wherein the coupling assembly is configured to releasably couple the catheter handle to the introducer handle so as to prevent movement of the catheter with respect to the introducer along the longitudinal axis and to allow rotation of at least a section of the catheter handle and a after the catheter shaft is introduced through the transseptal port into the introducer handle and

[0015] 23.168P-WO | 23.09.2025 the introducer sheath and to allow manual and / or gear driven rotation of the catheter shaft into one pre-defined direction of rotation.

[0016] Furthermore, in particular, the above object is solved by a coupling assembly for use in a medical system comprising a catheter and an introducer, wherein the coupling assembly is initially separate from the catheter and the introducer, wherein the catheter comprises a catheter handle at its proximal end and an elongated catheter shaft extending distally from the catheter handle, wherein the introducer comprises an introducer handle at its proximal end and a tubular introducer sheath extending distally from the introducer handle and along a longitudinal axis, wherein the introducer handle comprises an inner lumen with transseptal port configured to guide the catheter shaft through the introducer handle and into the introducer sheath, wherein the coupling assembly is configured to releasably couple the distal end of the catheter handle to the proximal end of the introducer handle so as to prevent movement of the catheter with respect to the introducer along the longitudinal axis after the catheter shaft is introduced through the transseptal port into the introducer handle and the introducer sheath and to allow manual and / or gear driven rotation of the catheter shaft into one pre-defined direction of rotation.

[0017] As indicated above, the medical system comprises a catheter and an introducer for inserting and controlling the catheter within the patient’s body. The catheter comprises an elongated catheter shaft having a longitudinal axis and a catheter handle, wherein the catheter handle is located at the proximal end section of the catheter. The catheter shaft projects from the distal end of the catheter handle. The catheter further comprises a pull wire connected to an actuator (e.g. rotatable ring-like element at the distal end of the handle) to steer the catheter shaft, e.g. at a functional section. The catheter may be a catheter for treatment (therapy) and / or examination (diagnostics) of the patient’s tissue using an electrical field that is provided by at least one electrode accommodated at the distal end of the catheter shaft. The catheter may further comprise, at the distal end of the catheter shaft, at least one electrode, wherein the electrode is from a group comprising ring electrode and head electrode. In one embodiment, the catheter may comprise an active portion being arranged at a distal end of the catheter shaft wherein the angled portion may be angled with regard to the longitudinal

[0018] 23.168P-WO | 23.09.2025 axis of the catheter shaft, wherein the active portion comprises the least one electrode accommodated along the angled active portion at a pre-defined radial distance from the longitudinal axis of the catheter shaft. In one embodiment, the angled active portion may be formed as a loop. In one embodiment, the active portion may comprise as at least two PFA electrodes for therapeutic use (e.g. PVI) and / or at least one supplemental electrode for receiving and / or providing electrical signals from / to the patient’s tissue or bodily fluid, e.g. for electrophysiological diagnostics or therapeutic use (for example pacing). In particular, the ablation catheter may be used to provide cardiac catheter ablation to treat a variety of cardiac arrhythmias including AF. For example, the ablation catheter may be configured for being connected to a PF energy generator which is configured for delivering PF energy. The inventive catheter may also be used for ablation of different type of tissue, for example veins, lungs, liver, kidneys. It may be used for pulmonary vein isolation (PVI), persistent atrial fibrillation ablation, ventricular tachycardiac ablation and other ablation procedures. It may further be used for monopolar ablation (further comprising a counter electrode at the patient’s skin) or for bipolar ablation.

[0019] The catheter shaft is formed from tubular elements that is adapted to accommodate at least one electrode lead for the at least one electrode within its inner lumen. Consequently the catheter shaft may comprise tubular elements which may accommodate within its inner lumen at least one electrode lead connected to the at least one electrode. Each electrode at the active portion may be electrically connected via one electrode lead to a power supply and a pulse generator provided at the proximal end of the catheter shaft.

[0020] The catheter shaft may comprise a tubular central section and the active portion at its distal end. The central section forms the section that just mechanically connects the proximal elements such as a handle or operating element, with the distal elements such as the active portion. The axis of the tubular central section is also referred to as longitudinal axis of the catheter shaft.

[0021] The active portion at the distal end of the catheter shaft is angled with regard to the main longitudinal axis of the catheter, in particular the longitudinal axis of the central section. This means that the active portion is inclined with regard to this axis by at least 30 °, e.g. by at

[0022] 23.168P-WO | 23.09.2025 least 60 ° if the active portion is projected into a plane comprising the longitudinal axis of the central section. The at least one electrode accommodated along the active portion is arranged at a pre-defined distance from the longitudinal axis. During treatment and / or examination of the patient's tissue, e.g., ablation and / or mapping, the catheter shaft may be continuously or intermittently rotated by a pre-defined rotation angle, for example, by at least 270 °, for example by 360 °. Such rotation may take, for example, 1 second to 1 minute, e.g., 5 seconds to 30 seconds. The distance of the at least one electrode from the longitudinal axis determines the radius of the treatment and / or examination region at the patient's tissue, e.g., the ablation lesion, that may be formed as a circle or circle segment, for example, around the patient's PVO or around its antrum. Due to this rotation, only a small number of electrodes (in case of monopolar PFA only one electrode) is needed so that the complexity of the system is greatly reduced.

[0023] In one embodiment, the at least one examination electrode is at least one mapping electrode and / or at least one measurement electrode and / or wherein the at least one treatment electrode is configured to map the vicinity of this electrode and / or to measure at least one pre-defined property of the patient's tissue in a respective mode. Accordingly, the at least one examination electrode may be used for mapping and / or measurement only. Alternatively, or additionally, the at least one treatment electrode may comprise at least two modes, the treatment mode and the respective examination mode (the examination mode may comprise, e.g., the measurement mode and / or the mapping mode). The treatment mode and the examination mode may be set by the ECU intermittently.

[0024] It is also within the scope of the present invention that the active portion may comprise at least one electrode for examination of a patient's tissue, e.g., a plurality of separate mapping electrodes, the mapping electrodes being configured for receiving electrical signals, e.g. electrical potential, from vascular or atrial tissue. Alternatively, the electrodes used for treatment, e.g. ablation, in the treatment mode, e.g. ablation mode, may be used for mapping in the mapping mode, namely receiving electrical signals, e.g. deriving electrical potential, from vascular or atrial tissue. During ablation these electrodes are in the ablation mode. This may enable mapping and ablation with a single ablation catheter for PVI as well as ablating some non-PV triggers for AF patients.

[0025] 23.168P-WO | 23.09.2025 For example, in an embodiment, a plurality of mapping electrodes may also be incorporated distal to the at least one ablation electrode, or medially within two ablation electrodes, e.g., between two ablation electrodes (along the active portion).

[0026] In one embodiment, the at least one examination electrode may be used to determine monopolar impedance to thereby ascertain that active portion is in contact with the patient's tissue along its entire outer surface.

[0027] In one embodiment, the active portion comprises two ablation electrodes, e.g., for PF A, wherein both ablation electrodes are accommodated along the active portion at the predefined radial distance from the longitudinal axis of the catheter shaft. Accordingly, the two ablation electrodes may produce a circular lesion or a lesion along a circular segment at the pre-defined treatment location. Regarding the embodiment where the catheter is used for PFA the inventive ablation catheter is intended to render tissues non-viable by irreversible electroporation (IRE). During IRE the electric field provided by the at least one electrode of the active portion creates pores in cardiac cell membranes. When the number of pores and their sizes are sufficiently great IRE occurs and the cell programs itself to die.

[0028] As a suitable material, the ablation and / or mapping electrodes may comprise, for example, at least one material of the group comprising a gold and a platinum / iridium alloy.

[0029] In one embodiment, the active portion is formed as a loop section. This form allows a treatment and / or measurement of the patient's tissue more precisely along a circular line or a circular segment line. The loop section may approximately be formed as a circular segment. The active portion or loop may be supported centrally. This allows an uniform contact pressure for all electrodes (diagnostic and therapeutic) to the tissue and prevents tilting of the loop. In this embodiment the normal axis of the plane containing the loop of the active portion (e.g. axis perpendicular to the plane of the loop) is angled with regard to the longitudinal axis of the central section.

[0030] In one embodiment the outer diameter of the active portion is, for example, in the range of

[0031] 23.168P-WO | 23.09.2025 5 to 7F. The outer diameter of the wire helix portion may be, for example, in the range of 1.5 to 1.7mm.

[0032] The medical system further comprises an introducer, wherein the introducer comprises an introducer handle at its proximal end and a tubular introducer sheath extending distally from the introducer handle and along a longitudinal axis, wherein the introducer handle comprises an inner lumen terminating with a transseptal port configured to guide the catheter shaft through the introducer handle and into the inner lumen of the introducer sheath. When inserting the catheter shaft into the introducer the distal end of the catheter first passes through the transseptal port which may comprise a hemostase valve. When the catheter shaft is fully inserted into the introducer, the catheter handle may abut on the hemostase valve. The introducer sheath of the introducer is configured such that the catheter shaft of the catheter is advanceable through the introducer sheath to the treatment and / or examination location within the patient’s body and such that the catheter shaft is rotatable within the introducer sheath. For example, the introducer sheath is used to guide the catheter with its active portion to the PVO. The catheter, in particular the supplemental electrodes, may be used to examine (measure / map) the treatment location first, namely when the active portion is located near the PVO. Then, PVI is conducted by PFA using the PFA electrodes. The rotational movement is transmitted via the catheter shaft to the active portion of the catheter. Thereby, the catheter shaft is rotated within the introducer sheath. Thereby a circular lesion or a lesion having the form of a circular segment is produced around the PVO or around its antrum. A continuous mapping / measuring of the electric signals at the treatment location may be provided.

[0033] The common feature of the above inventive devices (catheter, introducer and coupling assembly) is the coupling assembly that may either be attached to the catheter, to the introducer or may form an element that is initially separate from the catheter and the introducer as indicated above. However, after the catheter shaft is fully inserted through the transseptal port into the introducer handle and the introducer sheath, the coupling assembly releasably couples the distal end of the catheter handle to the proximal end of the introducer handle so as to prevent movement of the catheter with respect to the introducer along the longitudinal axis. Further, the coupling assembly allows manual and / or gear driven rotation

[0034] 23.168P-WO | 23.09.2025 of the catheter shaft within the introducer sheath into one pre-defined direction of rotation. In one embodiment, the coupling assembly is configured to prevent manual and / or gear driven rotation of the catheter shaft within the introducer sheath or of the catheter handle against the pre-defined direction of rotation.

[0035] The coupling assembly eases operation of the system comprising the catheter and the introducer because the catheter handle and the introducer handle are reliably but releasably coupled during manual operation by the HCP and can therefore be held with one hand. Manually, the catheter handle may be operated to rotate the catheter shaft within the introducer sheath. Alternatively or additionally, as indicated below, the catheter shaft may be automatically or semi-automatically rotated driven by a motor. Accordingly, precise operation of the medical system is possible. In particular, in case the catheter shaft is automatically rotated, the treatment or mapping / examination may be provided in minimal time.

[0036] The catheter of the medical system may form, for example, a PFA catheter comprising exactly two PFA ring electrodes accommodated at an active portion at the distal end of the catheter shaft having a loop form that is very well suited for PVI, but, with a smaller loop radius, may also be used for treatment of ectopic cardiac arrhythmias. Such a catheter may create a complete circular ablation line in approximately 40 seconds assuming a heart frequency of 1 Hz. This is comparable to the treatment time of so-called one-shot PFA systems using a number of electrodes that is considerably greater than two.

[0037] In one embodiment of the catheter or the introducer or the coupling assembly, the coupling assembly comprises a coupling member configured to form a positive locking connection or a frictional connection to the catheter handle and / or to the introducer handle. Such positive locking connection, e.g. a snap coupling, a sleeve comprising an L-type guiding track, screw coupling, carabiner, provides a cost-efficient coupling of the catheter and the introducer that may be easily decoupled. The L-type guiding track of the coupling member may guide a protrusion extending from an outer surface of the catheter handle or the introducer handle. For example, the protrusion from the introducer handle may be formed by an end section of a flushing tube as explained below in more detail. Alternatively, the coupling element may

[0038] 23.168P-WO | 23.09.2025 be configured to form a frictional connection to the catheter handle and / or to the introducer handle, for example a touch fastener or a magnet based coupling design.

[0039] Further, the coupling assembly of the catheter may comprise a hollow cylindrical structure at its distal end configured to receive the proximal end of the introducer handle to ease coupling. Further, such structure of the coupling assembly may comprise the L-shaped guide track (i.e. a through-going slit having a first section that extends in longitudinal direction for introduction of the flushing tube end section and a second section formed by an arcuate slit branching off the first section and extending in circumferential direction) for receiving and guiding the flushing tube end section when coupling the catheter to the introducer. The arcuate slit limits the relative movement of the catheter to the introducer in longitudinal direction.

[0040] In one embodiment of the catheter or the introducer or the coupling assembly, the coupling assembly comprises a gear configured to transmit a rotational movement from the catheter handle and / or from a torsion shaft to the catheter shaft. The gear may comprise a sprocket having, for example, a helical toothing. The sprocket may be driven by the torsion shaft comprising, for example, an evoloid at the first end forming the connection to the sprocket. The torsion shaft is connected to the driving motor by its second end that is opposite the first end. The sprocket may further be connected to a rotation element for manual operation (e.g. a cylindrical handle section, a ring element or a conical element) that drives the catheter shaft if it is rotated in a pre-defined rotation direction (e.g. clockwise rotation) and prevents catheter shaft rotation against the pre-defined rotation direction (e.g. anti-clockwise rotation). If the rotation element is rotated into the pre-defined rotation direction, the connected sprocket is driven similarly, whereas if the rotation element is rotated against the pre-defined rotation direction, the rotation may be stopped or decoupled / overrun (and thereby not transmitted to the catheter shaft).

[0041] In one embodiment of the catheter or the introducer or the coupling assembly, the coupling assembly is configured to prevent manual and / or gear driven rotation of the catheter shaft or of the catheter handle against the pre-defined direction of rotation. Thereby, as indicated above, it is avoided to perforate the wall of patient’s vessel, e.g. the wall situated closely to

[0042] 23.168P-WO | 23.09.2025 the PVO, with the distal end of the catheter shaft. For example, in one embodiment of the catheter or the introducer or the coupling assembly, the gear of the coupling assembly comprises at least one radially movable or pivotable stop cam configured to prevent the rotational movement of the catheter handle and / or the catheter shaft against the pre-defined direction of rotation and configured to be overrun if the catheter handle and / or the catheter shaft is rotated into the pre-defined direction of rotation. The stop cam may be located at a circumferential surface of a rotating element which is or rotates with the manually operatable catheter handle or catheter handle section. The stop cam may comprise, for example, a stop surface interacting with a protrusion located at an inner surface of the sprocket when the sprocket and / or the rotation element is rotated against the pre-defined direction of rotation. The stop cam may further comprise, at the side opposite the stop surface, an inclined surface. Due to interaction with the protrusion located at the inner surface of the sprocket, the protrusion may slide along the inclined surface and may pivot the stop cam or may press the movable stop cam into a recess so that it is overrun thereby allowing rotation of the catheter shaft into pre-defined rotation direction. Further, this mechanism provides manual driving of the sprocket by rotation of the handle or handle section due to the connection via the stop cam and protrusion.

[0043] In one embodiment of the catheter or the introducer or the coupling assembly, the catheter comprises a central control unit being a central electronic control unit (central ECU) electrically connected to and configured to control a motor control unit controlling a motor which provides a rotational movement for transmission to the coupling assembly, e.g. by a torsion shaft, and / or electrically connected to and configured to control a PFA generator connected to the PFA electrodes and / or electrically connected and configured to receive and / or provide electrical signals from / to the at least one supplemental electrode. In one embodiment of the catheter or the introducer or the coupling assembly, the motor control unit is configured to receive control signals from a foot pedal and / or from the central control unit, wherein the motor control unit is electrically connected to the foot pedal.

[0044] In one embodiment, the central ECU comprises and uses a data processor / computer or the like and is configured to control operation of each of the at least one PFA electrode and, if applicable, each of the at least one supplemental electrode. In one embodiment, the operation

[0045] 23.168P-WO | 23.09.2025 control of the central ECU comprises and / or realizes an ablation mode and a sensing mode with regard to the at least one PFA electrode. This means that the respective PFA electrode may be switched between the sensing mode and the ablation mode, wherein in the sensing mode the respective electrode detects the surrounding electromagnetic signals of the tissue and in the PFA mode the respective electrode provides a pre-defined ablation pulse or pulse train to a target location of a tissue. The central ECU may be configured to only switch the mode of all PFA electrodes, a single PFA electrode or of a subgroup of all ablation electrodes at a pre-defined, specific time. To ease and improve assessment of the received electromagnetic signals of the electrodes in the sensing mode the central ECU may be configured to compute date that may be used to visualize the signals with regard to their local distribution using standard imaging technology (so-called mapping).

[0046] In one embodiment of the catheter or the introducer or the coupling assembly, the electrical connection from the central control unit to the catheter handle for providing PFA signals to the PFA electrodes and / or electrical signals from / to the at least one supplemental electrode is provided by a patient cable via a rotary feedthrough. In one embodiment, the motor and / or the rotary feedthrough are fixed to a rail of a surgical table. The fixing may be releasably. Accordingly, a reliable mounted medical system is provided which prevents tangled cables.

[0047] In one embodiment of the catheter or the introducer or the coupling assembly, the central control unit is configured to provide motor control signals to the motor control unit for automatic drive of the catheter shaft rotation and / or to provide PFA control signals to the PFA generator for automatic electric signal generation and transmission to the at least one PFA electrode, wherein, for example, the motor control signals and the PFA control signals are synchronized. The motor control unit may be connected to the coupling assembly using a torsion shaft, wherein the torsion shaft may be protected by an outer sleeve protecting the torsion shaft.

[0048] The central ECU may be electrically connected to a graphical user interface (GUI), for example a screen. The HCP may observe the treatment progress and / or the treatment position, including, if applicable, the surrounding area at the GUI based on the electrical signals received from the at least one electrode of the active portion, e.g. from the at least

[0049] 23.168P-WO | 23.09.2025 one supplemental electrode. Such electrical signals include IEGM signals, and impedance values. The received electrical signals are processed in the central ECU such that the treatment progress and / or treatment area can be visualized at the GUI.

[0050] The central ECU may comprise the PF A generator and / or the motor control unit, wherein the PF A generator and / or the motor control unit form integrated or separate elements of the central ECU.

[0051] After manual positioning of the active portion (e.g. formed as a loop) of the catheter shaft at the treatment position, the HCP has several handling options to choose from: a) manually rotating the catheter shaft (e.g. including its active portion) using the second hand and observing graphics received by processing the IEGM signal at the GUI, b) motorized rotation of the catheter shaft (e.g. including its active portion) using food pedal control, e.g. stepwise rotation, and observing graphics received by processing the IEGM signal at the GUI, c) manually triggered motorized (i.e. automatic) rotation of the catheter shaft (e.g. including its active portion) and automatic processing the IEGM signal aiming at automatic stop of rotation if the PFA electrodes are located at the calculated treatment position, d) manually triggered motorized (i.e. automatic) rotation of the catheter shaft (e.g. including its active portion) to the treatment position based on IEGM signal processed by means of Al algorithms and subsequent automatically triggered PFA, wherein the entire sequence may always be stopped by pressing the foot pedal.

[0052] Another advantage of the inventive catheter, introducer or coupling assembly is that the HCP is required to carry only one (combined) handle in a single hand, which has been formed by coupling the catheter handle with the introducer handle. Further, the catheter, the introducer and the coupling assembly is simple and inexpensive to manufacture because the rotary feedthrough and the motor are fixed to the surgical table, wherein the motor is connected to the catheter, introducer or coupling assembly via a resterilizable torsion shaft.

[0053] In one embodiment, the operation of the medical system allows the use of artificial intelligence (Al) algorithms that may, for example, adapt to individual user procedures.

[0054] 23.168P-WO | 23.09.2025 The above object is further solved by a medical system comprising

[0055] • a catheter as explained above and an introducer, wherein the introducer comprises an introducer handle at its proximal end and a tubular introducer sheath extending distally from the introducer handle and along a longitudinal axis, wherein the introducer handle comprises an inner lumen with transseptal port configured to guide the catheter shaft through the introducer handle and into the introducer sheath, or

[0056] • an introducer as explained above and a catheter, wherein the catheter comprises a catheter handle at its proximal end and an elongated catheter shaft extending distally from the catheter handle, or

[0057] • a coupling assembly as a separate element as explained above, an introducer and a catheter, wherein the introducer comprises an introducer handle at its proximal end and a tubular introducer sheath extending distally from the introducer handle and along a longitudinal axis, wherein the introducer handle comprises an inner lumen with transseptal port configured to guide the catheter shaft through the introducer handle and into the introducer sheath and the catheter comprises a catheter handle at its proximal end and an elongated catheter shaft extending distally from the catheter handle.

[0058] Such medical system has the advantages as explained above with regard to the catheter, the introducer and the coupling assembly.

[0059] The present invention will now be described in further detail with reference to the accompanying schematic drawing, wherein

[0060] Fig. 1 shows a catheter and an introducer in a coupled state of an embodiment of a medical system in a perspective side view,

[0061] Fig. 2 depicts the proximal end of the medical system of Fig. 1 in a first step prior coupling in a perspective side view,

[0062] Fig. 3 illustrates the proximal end of the medical system of Fig. 1 in a second step prior coupling in a perspective side view,

[0063] 23.168P-WO | 23.09.2025 Fig. 4 shows the proximal end of the medical system of Fig. 1 in a coupled state in a perspective side view,

[0064] Fig. 5 illustrates six steps (step a) to step f)) of the ablation procedure using the medical system of Fig. 1 displayed at a GUI,

[0065] Fig. 6 shows the medical system of Fig. 1 in a fully installed and mounted way,

[0066] Fig. 7 depicts the electronic components of the medical system of Fig. 1 and their connections,

[0067] Fig. 8 illustrates the coupling assembly of the catheter of the medical system of Fig. 1 in a side view in the state coupled to the introducer,

[0068] Fig. 9 shows the coupling assembly of Fig. 8 partially cut,

[0069] Fig. 10 depicts the coupling assembly of Fig. 8 in a partial longitudinal section,

[0070] Fig. 11 illustrates the coupling assembly of Fig. 8 in a cross section when rotated in a first rotation direction,

[0071] Fig. 12 depicts the coupling assembly of Fig. 8 in a cross section when rotated in a second rotation direction.

[0072] An embodiment of the medical system according to the invention is shown in Fig. 1 to 12. Fig. 1 shows the part of the medical system 1 comprising the catheter la and the controllable transseptal introducer lb in the coupled state for intracardiac therapeutic use. This coupling is fixed, but can be released at any time. The distal end of the introducer sheath 2 is shown partly cut to visualize a catheter shaft 4 and a torsion segment 3 of the catheter shaft 4. The length (dimension in longitudinal direction) of the torsion segment 3 corresponds to the length of the deflectable end of the introducer sheath 2. An active portion of the catheter shaft 4 located at the distal end of the catheter shaft 4 forms a circular loop 5. The active

[0073] 23.168P-WO | 23.09.2025 portion with the loop 5 of the catheter la protrudes straight out of the distal end of the introducer sheath 2. The center axis or loop rotation axis (see dot-dashed line 16 in Fig. 1) of the distal end of the loop 5 is perpendicular to the plane defined by the loop 5. The distal end of the catheter shaft 4 forming the loop 5 comprises an PFA electrode pair 6 and, for example, five supplemental electrodes 7 for diagnostic and therapeutic purposes, such as IEGM and pacing. The introducer lb comprises an introducer handle 8 at its proximal end. Similarly, the catheter la comprises a catheter handle 12 at its proximal end. The catheter shaft 4 is fixedly connected to the distal end of the catheter handle 12 so that the catheter shaft 4 rotates with the rotation of the catheter handle 12.

[0074] In the shown embodiment, the deflection of the introducer lb and therefore of the catheter shaft 4 is set using a rotary knob 9 located at the distal end at the introducer handle 8. A flushing connection tube 10 with a Luer lock 11 extends sideways from the introducer handle 8 to protect the lumen between the catheter shaft 4 (e.g. at the torsion segment 3) and the inner lumen of the introducer sheath 2 from penetrating blood components and thus the patient from the risk of thrombosis using a small flow of saline solution.

[0075] The catheter la is fixedly coupled to the introducer handle 8 using the coupling assembly 13 (see Fig. 2 to 4) so as to prevent movement of the catheter la with respect to the introducer lb along the longitudinal axis of the catheter shaft 4 or the introducer sheath 2. The coupling can be released at any time. This connects the catheter handle 12 and the introducer handle 8 of the sheath lb so as to form a single handle of the medical system 1. The coupling assembly 13 comprises a transmission connection 15, to which the torsion shaft line 60 (see Fig. 6) is connected after the coupling step. The transmission connection 15 forms a connection to an internal mechanical gear located within the coupling assembly 13. Fig. 9 to 12 show an embodiment of such a gear in more detail. The gear transforms the rotation introduced by the torsion shaft line 60 via the transmission connection 15 into a slow, reduced rotation of the catheter handle 12 about the handle rotation axis 18 in a pre-defined rotation direction (see arrow 19 in Fig. 1). From the HCP's point of view, in the present embodiment a clockwise rotation is provided. Driven by rotation of the catheter handle 12, the catheter shaft 4 and thus its distal loop 5 rotates about the loop rotation axis (see dot- dashed line 16) in the loop rotation direction (see arrow 17 in Fig. 1). The catheter handle

[0076] 23.168P-WO | 23.09.2025 12 may also be rotated manually by the HCP in the direction of the arrow markings 20 shown at the outer surface of the catheter handle 12. Defining the indicated direction of rotation (see arrow 19) prevents the distal end of the loop 5 from causing a perforation of the vessel wall.

[0077] The connection socket 14 for the patient cable 29 (see Fig. 6) is located on the proximal outer front surface of the catheter handle 12. The patient cable 29 may be used, for example, to transmit the PFA energy to the PFA electrodes 6, IEGM signals (intracardial electrocardiogram signals) detected by the supplemental electrodes located at the distal end of the catheter shaft 4 to a central ECU 43 (see Fig. 7) and therapeutic pacing voltage pulses to the distal end of the catheter shaft 4.

[0078] Fig. 2 to 4 shows the steps of coupling the catheter la with the steerable transseptal introducer lb to form the medical system 1 illustrated in Fig. 1. In Fig. 2, the shaft 4 of the catheter la is shown already introduced into the introducer lb at its proximal end and through a hemostasis valve 61 at the transseptal port of introducer lb. The coupling assembly 13 with the inner gear is rotatably connected to the catheter handle 12. The inner surface 22 of the coupling assembly 13 is precisely adapted to the outer surface of the provided airlock handle 8. In Fig. 3, the catheter la is shown inserted into the sheath lb as far as possible, abutting to the proximal end face of the introducer handle 8. A quarter turn of the coupling assembly 13 then couples the catheter handle 12 and the introducer handle 8 by the claw 21 of the coupling assembly 13 embracing the flushing connection tube 10 extending sideways from the introducer handle 8 (Fig. 4). The positive fit between the inner surface 22 of the coupling assembly 13 and the outer surface of the introducer handle 8 allows the coupling

[0079] 13 to snap in elastically thereby providing a positive locking connection.

[0080] Fig. 6 shows the medical system 1 in a fully coupled state and positioned ready for treatment at a pulmonary vein ostium 65 of a patient’s heart 23. A flushing line 24 for supplying the introducer lb with the saline flushing solution is connected to a Luer lock 11 of the flushing connection tube 10. A transmission shaft plug 27 of the torsion shaft line 60 is connected to the transmission connection 15 (no longer visible here) of the coupling assembly 13 at the

[0081] 23.168P-WO | 23.09.2025 one end of the torsion shaft line 60. The torsion shaft line 60 is mechanically connected to a positioning motor 37 at the opposite end.

[0082] The patient cable 29 with its plug 28 is plugged into the connection socket 14 (no longer visible here) of the catheter handle 12. At one side of the surgical table 36 located opposite from the position of the HCP, a rotary feedthrough 30 is attached to a standard surgical table rail 35 (in accordance with DINEN ISO 19054) by means of a clamp holder. The positioning motor 37 coupled to the torsion shaft line 60 is also attached there by means of another clamp holder. The torsion shaft line 60 comprises of a protective tube 25 and a torsion shaft 26, wherein the torsion shaft 26 is guided within the protective tube with low torsional friction to transmit the motor rotation output of the positioning motor 37 to the gear of the coupling assembly 13.

[0083] The patient cable 29 is connected with its second plug 28 to a rotary feedthrough 30. The rotary feedthrough 30 prevents the patient cable 29 from twisting during the continuous or discontinuous rotation of the loop 5 or the catheter handle 12. The rotary feedthrough 30 passively rotates in the same direction 53 as catheter handle 12.

[0084] Fig. 7 schematically shows further members of the medical system 1. Beside the positioning motor 37 further peripheral devices, namely a PF A generator 40, an electrophysiological tracer (EP tracer) device 41, a motor control unit (MCU) 42, and an electrocardiography (ECG) device 62. The PFA generator 40 supplies the PFA power 50 and signals 49 via the electrical PFA generator line 34 to the rotary feedthrough 30. From there, the PFA energy is conducted via the patient cable 29 into the catheter la to act on the cell tissue, e.g. in the pulmonary vein ostia 65 (see Fig. 6) using the PFA electrode pair 6. The PFA may be triggered via a PFA foot pedal 45 (coupled to the PFA generator) and may then run according to pre-defined procedures triggered by the ECG device 62. For this purpose, the ECG device 62 processes the ECG signals 63 from leads connected to the patient's surface into a systole trigger signal 64 and transmits it to the the PFA generator 40. The EP tracer 41 further receives the IEGM signals 49 from the supplemental electrodes 7 of the catheter la and may deliver pacing voltage pulses 48 via the IEGM lead 33. The EP tracer device 41 is plugged with a connector 32 of the IEGM line 33 into a corresponding socket located at the bottom

[0085] 23.168P-WO | 23.09.2025 of the branch 31 of the rotary feedthrough 30. From there, the electrical connection is provided via the patient cable 29 to the catheter la and finally to the electrodes 7 abutting the cell tissue, e.g. at a pulmonary vein ostium 65.

[0086] The MCU 42 controls the positioning motor 37 using control signals 46 via the motor connection line 38 and receives angular position signals 47 of the motor 37 which are transmitted to the central ECU 43. The torsion shaft 26 of the torsion shaft line 60 forming the output of the positioning motor 37 drives the gear of the coupling assembly 13, which in turn causes the catheter handle 12 and thus the loop 5 to rotate to the pre-defined angular position at a pulmonary venous ostium 65 (see Fig. 6). The MCU 42 may also be activated (i.e. triggered or operated) using an MCU foot pedal 44 that is connected to the MCU 42.

[0087] The central ECU 43 processes the data received from the PFA generator 40, the EP tracer 41, the MCU 42, and the ECG device 62 and makes them at least partly available to the HCP at the GUI on a display 39. Additionally, the central ECU 43 is configured for parameter and settings input for the PFA generator 40, the EP tracer 41, the MCU42, and the ECG device 62.

[0088] Fig. 5 shows a schematic example of a sequence of six treatment states / steps during a PVI, as it may appear on the display 39, wherein the image data are provided by the central ECU 43. At the display 39, a loop avatar 52 of the loop 5 is displayed in a virtual view simulating the HCP views the loop avatar 52 from distal to proximal direction. The positions of the PFA electrode pair 54 and the supplemental electrodes 57 may be highlighted in color and shape such that they correspond to the location of the electrodes 6, 7 of the loop 5. In step a), for example, an image of an area 55a of high myocardial activity, which has been analyzed and calculated from the IEGM data, appears behind the loop avatar 52. In this case, for treatment the PFA electrode pair 6, 54 has to be positioned within the area of large myocardial activity, i.e. referring to the virtual view within the area of large myocardial activity 55a, by rotating the loop 5 in order to complete the PVI. At the same time, a message "Not complete! " shown, for example, in the display section 56 may appear to indicate clearly that the PVI is still incomplete. Alternatively, it is possible to display counterclockwise rotation of the avatar 52 background area instead of the clockwise rotation of the loop 5 or its avatar 52 on the GUI

[0089] 23.168P-WO | 23.09.2025 5. In this case, the loop avatar 52 may remain fixed as shown in sequences a) to d). The PFA ablation is then started using a PFA foot pedal 45 that is connected to the PFA generator 40, which may be visualized on the display 39 of the GUI 51 as a flashing lightning symbol 59 (see Fig. 5e)). Caused by the PFA treatment, the electrical signals received from this area change. Accordingly, in the visualization at display 39, an area image of high myocardial activity 55a fades as indicated by reference sign 55b in Fig. 5e), wherein the information for visualization may be based, for example, on the IEGM results derived between single ablation steps. After finishing the procedure (complete disappearance of myocardial activity), message "Complete" may appear in section 58 of the display 39, indicating that the PVI has been successfully completed (see Fig. 5f)).

[0090] Fig. 8 shows the coupling assembly 13 using an exemplary transmission, e.g. an evoloid transmission. Fig 8 shows the side view of the catheter handle 12 to which the coupling assembly 13 is fixed. The coupling assembly 13 comprises a gear housing 66 and a coupling member 67. In Fig. 9, the gear housing 66 and the coupling member 67 are shown in section, thus illustrating the positive-locking connection 72 of the gear housing 66 and the coupling member 67 and showing the sprocket 68 with its inclined helical teeth. In this illustration, the torsion shaft line 60 is also shown partially cut in the uncoupled state. An evoloid (rotating body) 69 is located at the end of the torsion shaft 26 and protrudes from the torsion shaft line connector 27, which may comprise, for example a Luer-Lock male thread for connecting with the coupling assembly 13. Figure 10 shows the gear housing 66 cut open to the center plane. In this Fig. 10, the torsion shaft connector 27 is shown screwed to the transmission connection 15, which may comprise a female Luer lock thread. The evoloid 69 rotates slightly into the helical teeth of the sprocket 68 when connecting the torsion shaft line 60. The sprocket 68 is rotatably mounted and radially centered on the catheter handle 12. Axial movement of the sprocket 68 is prevented by the gear housing 66 and the coupling member 67. There is also an annular gap 71 between the sprocket 68 and the catheter handle 12, the function of which is explained with reference to Fig. 11 and 12. The coupling member 67 is radially inserted into a distal catheter handle cover 70 and rotatably mounted. The catheter shaft 4 glued into the distal catheter handle cover 70 thus centers the coupling member 67 and thus the clipped-in gear housing 66.

[0091] 23.168P-WO | 23.09.2025 Fig. 11 and 12 schematically show the driving function of the driven sprocket 68 of the coupling assembly 13 as seen from distal to proximal. As one can derive from both Figs., one or more (e.g. two) protrusions 73 project from the inner surface of the sprocket 68 and interact with one or more (e.g. two) stop cams 77 on the catheter handle 12. Figure 11 shows the drive direction 76 pushing the catheter handle 12 by by the stop cams 77. In the indicated drive direction (see arrow 76), the stop cams 77 can run away from the protrusion 73 (allowed rotation) if the catheter handke 12 is manually turned in drive direction. In the opposite direction (see arrow 76a) of the catheter shaft 12, the protrusions 73 abut on the radially extending stop surface of the stop cam 77. The catheter handle 12 is thus blocked for rotation in the opposite direction (see arrow 76a) and must always rotate with the sprocket 68 in the same direction. The fixed direction of rotation of the catheter handle 12 ensures that the end of the loop 5 may not perforate the vessel wall at the pulmonary vein ostium 65. Figure 12 shows the same scheme, but with an intended manual rotation of the handle 12 in the "allowed" direction of rotation. This intervention may take place if the positioning motor 37 stopped or if the torsion shaft line 60 disconnected. During manual rotation, each stop cam 77 of the catheter handle 12 is pressed from an initial position into one recess 74 by the protrusions 73 against a reset force as they pass past them. Afterwards, the stop cams 77 may move up again driven by the reset force and may be engaged again by the protrusions 73 when the sprocket 68 is driven by the evoloid 69 of the torsion shaft line 60.

[0092] An exemplary method using the inventive catheter, introducer or coupling assembly, i.e. the inventive medical system, may be conducted when treating a patient by PVI having the following steps:

[0093] 1. puncture of the atrial septum,

[0094] 2. insertion of the controllable transseptal introducer lb into the patient’s body,

[0095] 3. removal of the puncture needle and the dilator,

[0096] 4. aspiration of blood and air bubbles at the Luer lock 11,

[0097] 5. establishing a continuous flushing using the flushing line 24 with physiological saline solution at Luer lock 11,

[0098] 6. insertion of the PF A catheter la into the proximal end of the introducer at the introducer’s proximal front surface through a transseptal port,

[0099] 23.168P-WO | 23.09.2025 7. coupling of the catheter handle 12 and its coupling assembly 13 with the introducer handle

[0100] 8,

[0101] 8. connecting the patient cable 29 to the catheter handle 12,

[0102] 9. connecting the torsion shaft line 60 to the coupling assembly 13 at the transmission connection 15, and

[0103] 10. positioning of the loop 5 at the distal end of the catheter shaft 2 using the controllable transseptal introducer lb at the first PVO 65.

[0104] 11. In the next step, at least five further procedures for rotating the loop 5 and for PFA are possible: a.) The HCP rotates the catheter handle 12 of the catheter la with his second hand in the direction of the arrow markings 20 until - as shown on the display 39 as explained above - the area image of high myocardial activity 55a comes to lie under the image of the PFA electrode pair 54. The IEGM signals of electrodes 6 and 7 are always gathered. The introducer lb is held in position with the other hand using the introducer handle 8. The HCP then triggers the PFA treatment using the PFA foot pedal 45. b.) The HCP presses the MCU foot pedal 44 of the MCU 42 to slowly rotate the catheter handle 12 of the catheter la automatically using the positioning motor 37. When the area image of high myocardial activity 55a comes to rest under the PFA electrode pair 54, the user releases the foot pedal 44 and the rotation stops. The IEGM signals from electrodes 6 and 7 are always gathered. At the same time, the introducer lb is held in position with one hand. Accordingly, the HCP only needs one hand at the introducer handle 8. The HCP then triggers the PFA by actuation of the PFA foot pedal 45. c.) The HCP presses the MCU foot pedal 44 connected to the MCU 42 so that the catheter handle 12 automatically rotates slowly until the area image of high myocardial activity 55a comes to lie under the image of the PFA electrode pair 54 and the MCU 42 automatically stops the positioning motor 37. The IEGM signals from electrodes 6 and 7 are always gathered during this process. At the same time, the introducer Ib is held in position with one hand. The user then triggers the PFA with the PFA foot pedal 45. d.) The HCP presses the MCU foot pedal 44 of the MCU 42 so that the handle 12 of the catheter la automatically rotates slowly until the area image of high myocardial activity 55a comes to lie under the image of the PFA electrode pair 54 and the MCU 42 automatically stops the positioning motor 37. At the same time, the introducer lb is held in position with

[0105] 23.168P-WO | 23.09.2025 one hand. The PFA is then triggered automatically after a warning signal. The HCP may interrupt the PFA and rotation of the loop at any time by pressing the respective foot pedal 44, 45. The positioning and PFA control is provided on the basis of an Al analysis of the IEGM signals from electrodes 6 and 7. The PFA procedure is finished, for example, by displaying a "Complete" message at the display 39. e.) The HCP presses the MCU foot pedal 44 of the MCU 42 so that the catheter handle 12 of the catheter la and thereby the loop 5 rotates slowly and automatically. The PFA starts at the same time. On the display, the user sees how the marked areas of large myocardial activity 55a, in which myocardial excitation activity still predominates, fade (see area 55b in Fig. 5e)) after passing the PFA electrode pair and then disappear completely. The message "Complete" appears and signalizes to the HCP that the PFA procedure is finished.

[0106] For all maneuvers, the HCP may also position the loop 5 manually thanks to the drive function of the gear of the coupling assembly (Fig. 11 and 12). Accidental rotation in the opposite direction is blocked by protrusions 73 and stop cams 77.

[0107] The exemplary method may be continued with the following steps:

[0108] 12. when all PVOs have been isolated, the torsion shaft line 60 may be disconnected,

[0109] 13. the patient cable 29 may be disconnected,

[0110] 14. the catheter handle 12 is decoupled from introducer lb and the catheter la is removed from the patient’s body, and

[0111] 15. the introducer lb is removed from the patient’s body.

[0112] 23.168P-WO | 23.09.2025

Claims

- 24 -Claims1. A catheter (la) for use in a medical system (1) comprising the catheter and an introducer (lb), wherein the catheter comprises a catheter handle (12) at its proximal end and an elongated catheter shaft (4) extending distally from the catheter handle, wherein the introducer comprises an introducer handle (8) at its proximal end and a tubular introducer sheath (2) extending distally from the introducer handle and along a longitudinal axis, wherein the introducer handle comprises an inner lumen with transseptal port configured to guide the catheter shaft through the introducer handle and into the introducer sheath, wherein the catheter handle comprises a coupling assembly (13) at its distal end, wherein the coupling assembly is configured to releasably couple the catheter handle (12) to the introducer handle (8) so as to prevent movement of the catheter with respect to the introducer along the longitudinal axis after the catheter shaft is introduced through the transseptal port into the introducer handle and the introducer sheath and to allow manual and / or gear driven rotation of the catheter shaft (4) into one pre-defined direction of rotation (arrow 75).

2. An introducer (lb) for use in a medical system (1) comprising a catheter (la) and the introducer, wherein the catheter comprises a catheter handle (12) at its proximal end and an elongated catheter shaft (4) extending distally from the catheter handle, wherein the introducer comprises an introducer handle (8) at its proximal end and a tubular introducer sheath (2) extending distally from the introducer handle and along a longitudinal axis, wherein the introducer handle comprises an inner lumen with transseptal port configured to guide the catheter shaft through the introducer handle and into the introducer sheath, wherein the introducer handle comprises a coupling assembly at its proximal end, wherein the coupling assembly is configured to releasably couple the catheter handle to the introducer handle so as to prevent movement of the catheter with respect to the introducer along the longitudinal axis and to allow rotation of at least a section of the23.168P-WO | 23.09.2025catheter handle and a after the catheter shaft is introduced through the transseptal port into the introducer handle and the introducer sheath and to allow manual and / or gear driven rotation of the catheter shaft into one pre-defined direction of rotation.

3. A coupling assembly for use in a medical system (1) comprising a catheter (la) and an introducer (lb), wherein the catheter comprises a catheter handle (12) at its proximal end and an elongated catheter shaft (4) extending distally from the catheter handle, wherein the introducer comprises an introducer handle (8) at its proximal end and a tubular introducer sheath (2) extending distally from the introducer handle and along a longitudinal axis, wherein the introducer handle comprises an inner lumen with transseptal port configured to guide the catheter shaft through the introducer handle and into the introducer sheath, wherein the coupling assembly is configured to releasably couple the distal end of the catheter handle to the proximal end of the introducer handle so as to prevent movement of the catheter with respect to the introducer along the longitudinal axis after the catheter shaft is introduced through the transseptal port into the introducer handle and the introducer sheath and to allow manual and / or gear driven rotation of the catheter shaft into one pre-defined direction of rotation.

4. The catheter according to claim 1 or the introducer according to claim 2 or the coupling assembly according to claim 3, wherein the coupling assembly comprises a coupling member (67) configured to form a positive locking connection and / or a frictional connection to the catheter handle and / or to the introducer handle (8).

5. The catheter according to any one of claim 1 and claim 4 or the introducer according to any one of claim 2 and claim 4 or the coupling assembly according to any one of claim 3 or claim 4, wherein the coupling assembly comprises a gear (68) configured to transmit a rotational movement from the catheter handle (12) and / or from a torsion shaft (26) to the catheter shaft (4).23.168P-WO | 23.09.20256. The catheter according to any one of claim 1 and claims 4 to 5 or the introducer according to any one of claim 2 and claims 4 to 5 or the coupling assembly according to any one of claim 3 or claims 4 to 5, wherein the coupling assembly (13) is configured to prevent manual and / or gear driven rotation of the catheter shaft (4) or of the catheter handle (12) against the pre-defined direction of rotation.

7. The catheter according to claim 6 or the introducer according to claim 6 or the coupling assembly according to claim 6, wherein the gear (68) of the coupling assembly comprises at least one radially movable or pivotable stop cam (77) configured to prevent the rotational movement of the catheter handle (12) and / or the catheter shaft(4) against the pre-defined direction of rotation and configured to be overrun if the catheter handle and / or the catheter shaft is rotated into the pre-defined direction of rotation.

8. The catheter according to any one of claim 1 and claims 4 to 7 or the introducer according to any one of claim 2 and claims 4 to 7 or the coupling assembly according to any one of claim 3 or claims 4 to 7, wherein the catheter comprises an active portion(5) being arranged at a distal end of the catheter shaft (4), wherein the angled portion may be angled with regard to the longitudinal axis of the catheter shaft, wherein the active portion comprises at least one electrode (6, 7) accommodated along the angled active portion at a pre-defined radial distance from the longitudinal axis of the catheter shaft.

9. The catheter according to any one of claim 1 and claims 4 to 8 or the introducer according to any one of claim 2 and claims 4 to 8 or the coupling assembly according to any one of claim 3 or claims 4 to 8, wherein the catheter (la) comprises at least two PFA electrodes (6) at the distal end of the catheter shaft (4) and / or the catheter comprises at least one supplemental electrode (7) at the distal end of the catheter shaft for receiving and / or providing electrical signals from / to the patient’s tissue or bodily fluid.23.168P-WO | 23.09.2025- 27 -10. The catheter according to any one of claim 1 and claims 4 to 9 or the introducer according to any one of claim 2 and claims 4 to 9 or the coupling assembly according to any one of claim 3 or claims 4 to 9, wherein the catheter comprises a central control unit (43) configured to control a motor control unit (42) controlling a motor (37) providing a rotational movement for transmission to the coupling assembly (13), e.g. by a torsion shaft (26), and / or configured to control a PFA generator (40) connected to the PFA electrodes (6) and / or configured to receive and / or provide electrical signals from / to the at least one supplemental electrode (7).

11. The catheter according to any one of claims 5 to 10 or the introducer according to any one of claims 5 to 10 or the coupling assembly according to any one of claims 5 to 10, wherein the motor control unit (42) is configured to receive control signals from a foot pedal (44) and / or from the central control unit (43).

12. The catheter according to any one of claim 1 and claims 4 to 11 or the introducer according to any one of claim 2 and claims 4 to 11 or the coupling assembly according to any one of claim 3 or claims 4 to 11, wherein the electrical connection from the central control unit (43) to the catheter handle (12) for providing PFA signals to the PFA electrodes (6) and / or electrical signals from / to the at least one supplemental electrode (7) is provided by a patient cable (29) via a rotary feedthrough (30).

13. The catheter according to any one of claim 1 and claims 4 to 12 or the introducer according to any one of claim 2 and claims 4 to 12 or the coupling assembly according to any one of claim 3 or claims 4 to 12, wherein the motor (37) and / or the rotary feedthrough (30) are fixed to a rail (35) of a surgical table (36).

14. The catheter according to any one of claim 1 and claims 4 to 13 or the introducer according to any one of claim 2 and claims 4 to 13 or the coupling assembly according to any one of claim 3 or claims 4 to 13, wherein the central control unit (43) is configured to provide motor control signals to the motor control unit (42) for automatic drive of the catheter shaft rotation and / or to provide PFA control signals to the PFA generator (40) for automatic electric signal generation and transmission to the at least23.168P-WO | 23.09.2025- 28 - one PFA electrode (6), wherein, for example, the motor control signals and the PFA control signals are synchronized.

15. Medical system comprising o a catheter according to any one of claims 1 and 4 to 14, wherein claims 4 to 14 refer to claim 1, and an introducer, wherein the introducer comprises an introducer handle (8) at its proximal end and a tubular introducer sheath (2) extending distally from the introducer handle and along a longitudinal axis, wherein the introducer handle comprises an inner lumen with transseptal port configured to guide the catheter shaft through the introducer handle and into the introducer sheath, or o an introducer according to any one of claims 2 and 4 to 14, wherein claims 4 to 14 refer to claim 2, and a catheter, wherein the catheter comprises a catheter handle (12) at its proximal end and an elongated catheter shaft (4) extending distally from the catheter handle, or o a coupling assembly according to any one of claims 3 to 14, wherein claims 4 to 14 refer to claim 3, an introducer and a catheter, wherein the introducer comprises an introducer handle (8) at its proximal end and a tubular introducer sheath (2) extending distally from the introducer handle and along a longitudinal axis, wherein the introducer handle comprises an inner lumen with transseptal port configured to guide the catheter shaft through the introducer handle and into the introducer sheath and the catheter comprises a catheter handle (12) at its proximal end and an elongated catheter shaft (4) extending distally from the catheter handle.23.168P-WO | 23.09.2025

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