Catheter arrangement, medical device implantation arrangement and method for implanting an implantable medical device

Abstract

A catheter arrangement (1) and a method for implanting an implantable medical device (3) are described. The catheter arrangement comprises a handle (5), an elongate outer catheter (7) and an elongate inner catheter (9) extending within the outer catheter. The handle comprises a first handle component (11) mechanically coupled with the outer catheter and a second handle component (13) mechanically coupled with the inner catheter. The second handle component is linearly displaceable relative to the first handle component such as to displace the inner catheter relative to the outer catheter along a longitudinal direction (15). Furthermore, the second handle component is rotatable relative to the first handle component such as to rotate the inner catheter relative to the outer catheter around a rotation axis parallel (17) to the longitudinal direction.

Description

[0001] Applicant: BIOTRONIK SE & Co. KG

[0002] Our Reference: 24.190P-WO

[0003] Date: 28.01.2026

[0004] CATHETER ARRANGEMENT, MEDICAL DEVICE IMPLANTATION ARRANGEMENT AND METHOD FOR IMPLANTING AN IMPLANTABLE MEDICAL DEVICE

[0005] The present invention relates to a catheter arrangement, to a medical device implantation arrangement and to a method for implanting an implantable medical device.

[0006] Implantable medical devices (IMD) are devices which are sufficiently miniaturized such as to be implanted within a body of a patient and which are configured for establishing a medical functionality. For example, an IMD may be adapted for triggering or monitoring a physiological function within the patient’s body. There are various types of IMDs. For example, intracardiac devices may be adapted for being implanted within a patient’s heart for example for triggering, supporting or monitoring a cardiac functionality. In the present application, the proposed approaches will be mainly described with reference to an implantable leadless pacemaker (sometimes also referred to as intracardiac pacemaker) forming an exemplary embodiment of an IMD. However, it is to be noted that the proposed approaches may also be applied to other types of IMDs.

[0007] Using a pacemaker, cardiac functionalities may be triggered or supported for establishing a regular, well synchronised heartbeat action. Conventionally, a pacemaker comprised a macroscopic housing to be implanted subcutaneously and a long lead having one end connected to a pacing circuitry within the housing and an opposite end to be implanted at the patient’s heart. Electric pulses generated by the pacing circuitry were then transmitted to an electrode provided at the opposite end of the lead.

[0008] In order to avoid disadvantages of such lead-based pacemakers, miniaturized pacemakers have been developed which are small enough to be implanted directly into a chamber of the patient’s heart. Such devices are known as implantable leadless pacemakers (ILP) and do not comprise an electrode at a lead but, instead, an electrode is generally arranged directly at a housing of such ILP in order to contact cardiac tissue therewith upon the ILP being implanted and fixed at such cardiac tissue.

[0009] Conventionally, the electrode of the ILP only slightly protrudes from the housing such that it generally contacts the cardiac tissue at its surface. However, it has been found that pacing the heartby applying electric pulses at a surface of myocardial tissue may be suboptimal in some cases as it may result in insufficient synchronization of heart contractions. In order to overcome such deficiencies, it has been found to be beneficial to transmit pacing pulses deeper within the cardiac tissue. Such technique is referred to as conduction system pacing (CSP). However, in order to apply pacing pulses to the conduction system of the heart, an electrode has to be introduced into the cardiac tissue by a significant distance of for example several millimeters instead of only touching the cardiac tissue at its surface.

[0010] The applicant of the present applicant described in prior US provisional applications 63 / 728,706 and 63 / 749,008 several types of ILPs in which an electrode arrangement is to be deployed such as to protrude significantly beyond a housing of the ILP. Upon being deployed, the electrode arrangement may therefore be introduced deeply into cardiac tissue and may serve for CSP. It is to be noted that approaches described in the present application may relate to an IMD including an electrode arrangement having characteristics and / or functionalities same or similar to those described in the prior applications. Accordingly, the content of the cited prior application shall be incorporated herein in its entirety by reference.

[0011] A more detailed description of conventional cardiac pacing, ILPs and CSP and their advantages and requirements is outlined further below in the “DETAILED DESCRIPTION” section.

[0012] There may be a need for an advantageous option for implanting an implantable medical device. Particularly, there may be need for a catheter arrangement, a medical device implantation arrangement and a method for implanting an IMD with which the IMD may be implanted in a simple and ergonomic manner while allowing, inter-alia, handling the IMD such as to control specific functionalities of the IMD. Specifically, the IMD may have to be handled such as to controllably extend or retract a deployable electrode thereof.

[0013] Such needs may be met with the subject matter of the independent claims. Advantageous embodiments are defined in the dependent claims as well as in the corresponding specification and figures.

[0014] According to a first aspect of the present invention, a catheter arrangement for implanting an implantable medical device is proposed. The catheter arrangement comprises a handle, an elongate outer catheter and an elongate inner catheter extending within the outer catheter. The handle comprises a first handle component mechanically coupled with the outer catheter and a second handle

[0015] 24.190P-WO / 28.01.2026component mechanically coupled with the inner catheter. The second handle component is linearly displaceable relative to the first handle component such as to displace the inner catheter relative to the outer catheter along a longitudinal direction. Furthermore, the second handle component is rotatable relative to the first handle component such as to rotate the inner catheter relative to the outer catheter around a rotation axis parallel to the longitudinal direction.

[0016] According to a second aspect of the present invention, a medical device implantation arrangement is proposed which comprises a catheter arrangement according to an embodiment of the first aspect of the present invention and further comprising an implantable medical device held at a distal end of the inner catheter of the catheter arrangement.

[0017] According to a third aspect of the present invention, a method for implanting an implantable medical device is proposed. The method comprises at least the following steps, preferably but not necessarily in the indicated order:

[0018] providing a medical device implantation arrangement according to an embodiment of the second aspect of the invention with the implantable medical device being initially accommodated within a protector cup at a distal end of the outer catheter ,

[0019] transferring the implantable medical device to an implantation site adjacent to a patient’s tissue, linearly displacing the second handle component relative to the first handle component to thereby displace the inner catheter relative to the outer catheter in a distal direction such as to eject the implantable medical device from the protector cup and fix at least a distal part of a housing of the implantable medical device at the patient’s tissue, and

[0020] rotating the second handle component relative to the first handle component to thereby rotate the inner catheter relative to the outer catheter such as to actuate a deployment mechanism of the implantable medical device such as to successively extend a deploy able electrode of the implantable medical device beyond the housing and into the patient’s tissue.

[0021] Ideas underlying embodiments of the present invention may be interpreted as being based, inter alia, on the following observations and recognitions.

[0022] Briefly summarized in a non-limiting manner, embodiments of the present invention relate to a catheter arrangement, a medical device implantation arrangement and a method for using same which allow actuating specific functionalities at an IMD by being specifically configured for enabling a rotation motion at a handle of the catheter arrangement additionally to enabling a translation motion at the handle and transmitting such rotation motion by an inner catheter of the catheter arrangement

[0023] 24.190P-WO / 28.01.2026to the IMD arranged at and mechanically coupled to a distal end of such inner catheter. Therein, the catheter arrangement is specifically configured for transmitting a torque applied between first and second handle components towards the IMD such as to actuate an IMD’s functionality such as a deployment or retraction of a deployable electrode arrangement. Accordingly, the catheter arrangement may be used for example for precisely deploying an electrode arranged at the electrode arrangement to a depths within cardiac tissue such as to enable conduction system pacing.

[0024] In the following, characteristics of embodiments of the present invention will be described in more detail.

[0025] The catheter arrangement proposed herein is specifically configured for implanting an IMD having at least two functionalities which are to be actuated and controlled by the catheter arrangement. For example, a first functionality of the IMD may be its capability of being fixed to a patient’s tissue by activating a fixation mechanism. The catheter arrangement may be configured for actuating such first functionality by implementing a first actuation motion to be applied at a handle of the catheter arrangement. A second functionality of the IMD may be its capability of deploying an electrode arrangement such as to position an electrode at an intended depth within the patient’s tissue. The catheter arrangement may be configured for actuating such second functionality by implementing a second actuation motion to be applied at the handle of the catheter arrangement. The first actuation motion and the second actuation motion are fundamentally different from each other. For example, the first actuation motion may be a linear translation whereas the second actuation motion may be a rotation.

[0026] In order to implement such different actuation motions to be applied at the handle of the catheter arrangement, the handle comprises at least two handle components. These two handle components are displaceable relative to each other. Furthermore, the catheter arrangement comprises at least an elongate outer catheter and an elongate inner catheter extending throughout the outer catheter. Particularly, the inner catheter may extend coaxially within the outer catheter. A proximal end of the outer and inner catheters is coupled with the handle whereas a distal end of the catheters holds the IMD.

[0027] Particularly, a first handle component is mechanically coupled with the outer catheter of the catheter arrangement and a second handle component is mechanically coupled with the inner catheter. Therein, the term “mechanically coupled” means that the respective one of the inner and outer catheters is fixed to the associated one of the first and second handle components in a way such that

[0028] 24.190P-WO / 28.01.2026a motion of the associated handle component may be transmitted onto the respective catheter coupled thereto.

[0029] Specifically, the first and second handle components shall be configured for enabling a relative linear displacement between both handle components and the handle components shall be coupled with the outer and inner catheters, respectively, in a manner such that this linear displacement is transmitted onto the catheters, respectively. Accordingly, by linearly displacing the first and second handle components relative to each other, the inner and outer catheters may be displaced relative to each other along a longitudinal direction. Therein, the longitudinal direction generally coincides with an extension direction of the elongate catheters. A maximum displacement distance by which the inner and outer catheters may be displaced relative to each other upon maximum linear displacement of the first and second handle components may be set such that the IMD held at the distal catheter end may be released from an initial configuration at the catheter arrangement. Generally, the maximum displacement distance roughly corresponds to or is slightly larger than an overall length of the IMD and / or of a protector cup accommodating the IMD. For example, the maximum displacement distance may be more than 1 cm, typically more than 3 cm or more than 5 cm, but typically less than 20 cm or less than 10 cm. In other words, the catheter arrangement may be configured such that its first and second handle components may be linearly displaced relative to each other to an extend such that the IMD held at the distal end of the inner catheter and being initially for example accommodated within a protector cup at the distal end of the outer catheter may for example be pushed out of the protector cup. Due to being ejected from the protector cup, a fixation mechanism at the IMD may be activated such as to fix the IMD at adjacent tissue. For example, upon being ejected, elongate tines at the distal end of the IMD may be released from an initial bent and / or stressed configuration upon the IMD being accommodated within the protector cup and may then engage into the adjacent tissue for fixing the IMD at the intended implantation site.

[0030] Furthermore, the first and second handle components shall be configured for enabling a rotation between the first and second handle components and the handle components shall be coupled with the outer and inner catheters, respectively, such that this rotation is transmitted onto the catheters relative to each other. Accordingly, by rotating the first and second handle components relative to each other, the inner and outer catheters may be rotated relative to each other around a rotation axis. Therein, the rotation axis generally is parallel or even coincides with the longitudinal direction along which the inner and outer catheters may be translated relative to each other. Particularly, the rotation axis may coincide with a middle axis of the inner and / or outer catheters. A maximum rotation angle by which the inner and outer catheters may be rotated relative to each other upon maximum rotation

[0031] 24.190P-WO / 28.01.2026of the first and second handle components may be set such that, upon the rotation being transmitted from the inner catheter to for example an actuation mechanism at the IMD, the IMD may be actuated for establishing its second functionality. For example, by rotating the first and second handle components and, correspondingly, rotating the inner and outer catheters relative to each other, the actuation mechanism at the IMD may be rotated in order to thereby deploy an electrode arrangement to an intended extend. For example, the maximum rotation angle may be more than 10°, typically more than 20°, more than 30°, more than 50° or more than 70°. In fact, the maximum rotation angle may even be more than 90°, more than 180° or more than 360°. In other words, the first and second handle components may be configured such as to enable one or more quarter, half or full rotations relative to each other. In other words, the catheter arrangement may be configured such that its first and second handle components may be rotated relative to each other to an extend such that the IMD held at the distal end of the inner catheter and being initially for example in a first configuration in which its deployable electrode arrangement is fully retracted may for example be actuated such as to deploy the electrode arrangement by rotating a deployment mechanism via the rotating inner catheter. Expressed differently, the catheter arrangement may be configured such that, due to a surgeon rotating its first and second handle components relative to each other, an actuation mechanism at the IMD may be driven into rotation in order to thereby deploy the electrode arrangement in a controlled manner.

[0032] This catheter arrangement according to the present invention is very intuitive for the physician handling the catheter. The linear movement of the first handle component relative to the second handle component directly transmits to a linear movement of the inner catheter with respect to the outer catheter. The same applies for the rotation. Thereby the physician can directly control the respective movement of the IMD. All movements at the handle directly translate in the same movements of the IMD.

[0033] According to an embodiment, the inner catheter is configured for transmitting a torque of at least 3 N-cm, preferably at least 4 N-cm, between its proximal end and its distal end upon being rotated around the rotation axis.

[0034] In other words, the inner catheter shall be mechanically configured with a substantive mechanical rotational stiffness, i.e. it shall have a substantive torque resistance, such as to enable transmitting a significant torque between its opposing ends in order to thereby allow transmitting a rotation of the first and second handle components coupled to the proximal end of the inner catheter to for example an actuation mechanism at the IMD coupled to the distal end of the inner catheter. Therein, the torque

[0035] 24.190P-WO / 28.01.2026shall be transmitted preferably in a quasi 1:1 torque translation. At least, the torque shall be transmitted in less than a 2: 1 torque translation. Expressed differently, a rotation applied between the first and second handle components shall be transmitted by the inner and outer catheters and shall result in a rotation of a same rotation extent (i.e. of a same rotation angle), almost a same rotation extent or at least more than a half rotation extent between the inner and outer catheters at their distal ends. Again in other words, a rotation executed between the first and second handle components shall be transmitted via the outer and inner catheter to the IMD to a rotation extend of more than 50%, preferably more than 80% or more than 90% compared to the rotation extent at the handle components. Therein, the required substantive mechanical rotational stiffness of the inner catheter may be achieved for example by suitably selecting a mechanically stiff material forming the inner catheter, suitably designing a shape of the inner catheter and / or suitably setting dimensions of the inner catheter.

[0036] According to an embodiment, the inner catheter has a hollow tube structure.

[0037] With such hollow tube structure, the inner catheter is for example cylindrical, particularly circular cylindrical, and encloses an inner volume / inner lumen. Such hollow tube structure may provide for superior mechanical rotational stiffness. For example, an inner diameter of the hollow tube structure may be more than 0.5 mm, preferably more than 1 mm or more than 2 mm, but typically less than 10 mm, preferably less than 5 mm or less than 3 mm. A wall thickness of the hollow tube structure may be more than 0.1 mm, preferably more than 0.2 mm or more than 0.5 mm, but typically less than 2 mm, preferably less than 1 mm or less than 0.6 mm.

[0038] According to a further specified embodiment, the inner catheter is formed with or reinforced with a braided wire structure and / or hypotube, in particular a laser-cut hypotube.

[0039] In other words, a braided wire may be used for forming or reinforcing the inner catheter. Therein, a wire may be arranged such as to form one or more coaxial coils, in particular at least two helically wounded coaxial coils, whereby each coil is wound in the opposite direction of the other coil. The wire and / or hypotube may comprise or consist of a mechanically highly loadable material such as a metal, for example stainless steel. With such braided wire structure and / or hypotube, the inner catheter may be provided with a very high torque resistance.

[0040] According to another further specified embodiment, an elongate tether may extend through an inner lumen enclosed by the hollow tube structure of the inner catheter.

[0041] 24.190P-WO / 28.01.2026The tether may comprise or be a cable, wire or suture. The tether may mechanically couple a housing or body of the IMD to the catheter arrangement during navigation and deployment until a fixation mechanism finally fixes it to tissue at an implantation site such that the tether may then be released. As also described in more detail further below, the tether may also be used upon repositioning the IMD.

[0042] According to an embodiment, a distal end of the inner catheter is provided with an alignment torquer which is configured for engaging with an engagement structure provided at a proximal end of the implantable medical device with a form fit between the alignment torquer and the engagement structure such as to transmit a torque between the inner catheter and the implantable medical device upon the inner catheter being rotated around the rotation axis, (claim 6)

[0043] In other words, the IMD may be provided with a specific engagement structure which is to be actuated for triggering a functionality of the IMD such as for deploying a deployable electrode arrangement. For example, such engagement structure may be implemented by a hitch extending from a portion of a housing of the IMD. Preferably, such engagement structure is arranged at the proximal end of the IMD, i.e. at the end facing towards the catheter arrangement. In order to actuate such engagement structure, the inner catheter of the catheter arrangement may have a structure referred to herein as alignment torquer at its distal end. Such alignment torquer may be shaped such as to enabling a form fit with the engagement structure at the IMD. Accordingly, a torque may be transmitted from the inner catheter via the alignment torquer to the engagement structure at the IMD in order to finally rotate this engagement structure together with the inner catheter. For example, upon the engagement structure being formed by a hitch protruding from the IMD, the alignment torquer may comprise a recess or slit into which such hitch may engage.

[0044] According to an embodiment, the inner catheter is provided with a fluoroscopically visible marker which is configured and arranged such as to enable visualizing a rotation motion of the inner catheter in fluoroscopy imaging.

[0045] Expressed differently, the inner catheter and particularly a region of the inner catheter close to its distal end may be provided with one or multiple markers which are visible in a fluoroscopy image, i.e. under x-ray illumination. Such markers may for example be dots, lines, symbols or similar structures consisting of an x-ray absorbing material. A marker may be applied to the inner catheter for example by locally depositing such x-ray absorbing material. The one or more markers may be

[0046] 24.190P-WO / 28.01.2026structured and / or arranged at the inner catheter such that, upon visualising the markers in a fluoroscopy image, information about a rotation configuration of the inner catheter may be derived. For example, plural markers may be distributed along the inner catheter and may be spaced from each other along the longitudinal direction and / or along a circumferential direction. In particular, alignment torquer is provided with one or more fluoroscopically visible markers.

[0047] According to an embodiment, the outer catheter is steerable and the first handle component is provided with a steering mechanism for steering the outer catheter.

[0048] In other words, the outer catheter may be adapted for being bent and / or for being rotated at least in a region close to its distal end such that the outer catheter may be steered along a path for example while pushing the outer catheter through blood vessels of a patient towards an implantation site. The direction and extend to which the outer catheter is steered may be controlled by a steering mechanism provided at the handle of the catheter arrangement, in particular at the first handle component.

[0049] According to an embodiment, a distal end of the outer catheter is provided with a protector cup for accommodating the implantable medical device, wherein the protector cup comprises embedded electrodes configured for providing a mapping capability.

[0050] Expressed differently, an end portion of the outer catheter close to its distal end may be provided with a protector cup being formed by a widened portion of the outer catheter such that the IMD may be accommodated therein for example during an implantation procedure in which the outer catheter together with the IMD is transferred towards an implantation site. At such protector cup, one or preferably plural electrodes may be embedded. The electrodes may be exposed towards an environment adjacent to the outer catheter such as to enable electrically contacting adjacent tissue of the patient. Furthermore, the electrodes may be electrically connected towards the handle including an evaluation circuitry or, alternatively, to a separate device including such evaluation circuitry and being electrically connected to the catheter arrangement. Using the electrodes, tissue adjacent to the protector cup may be electrically contacted and mapped for its electric characteristics during an implantation procedure in order to then derive information about its physiological characteristics and / or its ability to serve as an implantation site.

[0051] In the medical device implantation arrangement according to embodiments of the second aspect of the invention, the implantable medical device may comprise a housing, a fixation mechanism, a deployment mechanism and an electrode arrangement. The fixation mechanism may be configured

[0052] 24.190P-WO / 28.01.2026for fixing at least a distal part of the housing at a patient’s tissue. The deployment mechanism may be rotatable relative to the distal part of the housing. The electrode arrangement may include a deployable electrode which cooperates with the deployment mechanism such as to extend the electrode beyond the housing or retract the electrode towards the housing upon the deployment mechanism being rotated relative to the distal part of the housing.

[0053] Therein, the housing may enclose a circuitry for controlling or implementing a functionality of the IMD. For example, such circuitry may be for example a pacing circuitry for generating cardiac pacing pulses. Furthermore, the housing may accommodate an energy source such as a battery. The housing may be hermetically tight and / or may consist of biocompatible material or comprise such material at least at its outer surface.

[0054] The fixation mechanism is attached to the housing and is configured for engaging adjacent tissue for fixing the IMD at an implantation site. For example, according to an embodiment, the fixation mechanism may comprise plural elongate bendable tines arranged at the distal part of the housing and being configured for fixing the housing by engaging the tines with the patient’s tissue. Alternatively, the fixation mechanism may comprise for example a screw-like structure to be screwed into the patient’s tissue.

[0055] The deployment mechanism may be rotatable relative to at least the distal part of the housing to be fixed at the tissue. Accordingly, upon the fixation mechanism having been activated, the deployment mechanism may be actuated by rotating it using for example the inner catheter of the catheter arrangement. For such purpose, the deployment mechanism may be provided with an engagement structure such as a protruding hitch which may cooperate for example with an alignment torquer provided at the distal end of the inner catheter.

[0056] The electrode arrangement includes a deployable electrode which may be positioned at a substantial depth within the tissue and distant relative to the housing of the IMD. Therein, extending the electrode beyond the housing or retracting the electrode towards the housing may be controlled by suitably rotating the deployment mechanism relative to the distal part of the housing. Accordingly, by suitably rotating the first and second handle components at the handle of the catheter arrangement and thereby rotating the inner catheter relative to the outer catheter, the inner catheter may cooperate with the deployment mechanism at the IMD by transmitting torque to such deployment mechanism and thereby rotate the deployment mechanism. Due to such rotation, the deployment mechanism may

[0057] 24.190P-WO / 28.01.2026then translate a position of the electrode of the electrode arrangement towards an intended depth for example within cardiac tissue in order to enable for example conduction system pacing.

[0058] The IMD may be an implantable leadless pacemaker (sometimes also referred to as intracardiac pacemaker), in particular an implantable leadless pacemaker configured for conduction system pacing. Such implantable leadless pacemakers are disclosed in the co-pending applications of the applicant with the application numbers PCT / EP2025 / 085634, PCT / EP2025 / 085862 and US 63 / 749,008, which are hereby fully incorporated by reference.

[0059] In an embodiment of the implantation method according to the third aspect of the present invention, a medical device implantation arrangement as described herein may be used for implanting an IMD at an intended site within a patient’s body such as for example within a heart chamber.

[0060] Therein, the IMD may initially be accommodated within the protector cup of the catheter arrangement. With the IMD being protected by and enclosed within the protector cup, the outer catheter together with the inner catheter comprised therein may be introduced into the vessels of the patient and may be forwarded and steered towards the implantation site. Such forwarding and steering may be controlled using the handle of the catheter arrangement.

[0061] Upon having reached the implantation site, the IMD may be ejected from the protector cup. For such purpose, the first and second handle components may be displaced linearly relative to each other such as to push the IMD held at the distal end of the inner catheter out of the protector cup arranged at the distal end of the outer catheter. Due to such linear displacement of the inner and outer catheters relative to each other and the resulting ejection of the IMD from the protector cup, the fixation mechanism of the IMD may be activated in order to fixate the distal part of the housing of the IMD at the patient’s tissue. For example, upon being ejected from the protector cup, tines provided at the distal part of the housing and being bent into an extended configuration while being accommodated within the protector cup may be introduced into the adjacent tissue and may then relax into a predefined curved configuration to thereby fix the IMD at the tissue.

[0062] Finally, with the distal part of the housing being fixed in such manner, the deployment mechanism of the IMD may be actuated in order to successively extend the deployable electrode beyond the housing and into the patient’s tissue. For such purpose, the first and second handle components at the handle of the catheter arrangement may be rotated relative to each other and such rotation may be transferred via the inner catheter to the deployment mechanism at the IMD. Upon being rotated

[0063] 24.190P-WO / 28.01.2026in such way, the deployment mechanism may then push the deploy able electrode towards an intended depth position within the adjacent tissue in order to for example enable conduction system pacing.

[0064] It shall be noted that possible features and advantages of embodiments of the invention are described herein with respect to various embodiments of a catheter arrangement, of a medical device implantation arrangement and of a method for implanting an implantable medical device. One skilled in the art will recognize that the features may be suitably transferred from one embodiment or implementation to another and features may be modified, adapted, combined and / or replaced, etc. in order to come to further embodiments of the invention.

[0065] In the following, advantageous embodiments of the invention will be described with reference to the enclosed drawings. However, neither the drawings nor the description shall be interpreted as limiting the invention.

[0066] Figs. 1(A), (B) show an implantable medical device in different configurations with a deploy able electrode arrangement being retracted or extended, respectively.

[0067] Fig. 2 shows a handle of a catheter arrangement according to an embodiment of the present invention.

[0068] Figs. 3(A), (B) show partly transparent views of the handle of Fig. 2 in a first configuration and a linearly displaced second configuration, respectively.

[0069] Fig. 4 shows a distal end of a catheter arrangement according to an embodiment of the present invention.

[0070] Fig. 5 shows a protector cup of a catheter arrangement according to an embodiment of the present invention.

[0071] Fig. 6 shows an inner catheter of a catheter arrangement according to an embodiment of the present invention.

[0072] Figs. 7(A) - (C) visualize a sequence of method steps during implanting an implantable medical device with a medical device implantation arrangement according to an embodiment of the present invention.

[0073] 24.190P-WO / 28.01.2026The figures are only schematic and not to scale. Same reference signs refer to same or similar features.

[0074] Figs. 1(A), (B) show an example of an implantable medical device 3 to be implanted in a patient’s body using an embodiment of the approach described herein. In the example, the IMD 3 is an implantable leadless pacemaker. The IMD 3 comprises a housing 47, a fixation mechanism 49, a deployment mechanism 53 and an electrode arrangement 55. The housing 47 comprises a distal part 51 and a proximal part 65. The distal part 51 and the proximal part 65 may be displaced relative to each other in a distal direction 61 by rotating both parts 51 , 65 relative to each other around a rotation axis 17 corresponding to this distal direction 61. The fixation mechanism 49 comprises plural bendable tines 59 arranged at a distal end of the distal part 51 of the housing 47. In a mechanically relaxed configuration, these tines 59 are curved such that a portion of the tines 59 extends in the distal direction 61 and protrudes beyond a distal surface of the housing 47 while another portion of the tines 59 is curved in a backward direction against the distal direction 61. The tines 59 are made from a highly bendable material such as Nitinol. The electrode arrangement 55 comprises a deployable electrode 57 which may be extended from a retracted configuration as shown in Fig. 1(A), in which the electrode 57 at most only slightly protrudes beyond the distal surface of the housing 47 to a deployed configuration as shown in Fig. 1(B), in which the electrode 57 further protrudes beyond the distal surface of the housing 47.The electrode arrangement 55 may be actuated by the deployment mechanism 53 such as to extend the electrode 57 beyond the housing 47 and retract the electrode 57 towards the housing 47, respectively, upon the deployment mechanism 53 being rotated relative to the distal part 51 of the housing 47. In the example shown, the deployment mechanism 53 comprises a hitch 63 arranged at the proximal part 65 of the housing 47 which may be rotated relative to the distal part 51 of the housing 47. Therein, due to a provision of a threading 67, the proximal part 65 and the distal part 51 of the housing 47 are translated relative to each other along or against the distal direction 61 due to the induced rotation. As a result of such translation, the deployable electrode 57 of the electrode arrangement 55 may be extended or retracted, respectively.

[0075] An IMD 3 such as shown in Fig. 1 may be implanted using an embodiment of the approach described herein. Therein, the IMD 3 may be fixed at tissue at an implantation site using its fixation mechanism 49. Furthermore, the deployable electrode 57 may be extended deep into the tissue by suitably rotating the deployment mechanism 53. Using such deployed electrode 57 extending deep into the tissue, conduction system pacing may for example be enabled at the patient’s heart.

[0076] 24.190P-WO / 28.01.2026In order to enable such implantation, a catheter arrangement 1 and a medical device implantation arrangement 45 may be used, views and details of which being shown in Figs. 2 - 7.

[0077] The catheter arrangement 1 comprises a handle 5, an elongate outer catheter 7 and an elongate inner catheter 9 extending within the outer catheter 7. The handle 5 comprises a first handle component 11 and a second handle component 13. The first handle component 11 is mechanically coupled with the outer catheter 7 whereas the second handle component 13 is mechanically coupled with the inner catheter 9. Both handle components 11, 13 may be linearly displaced relative to each other thereby also linearly displacing the inner catheter 9 relative to the outer catheter 7 along a longitudinal direction 15. Additional to enabling such linear displacement, the first and second handle components 11, 13 are configured for being rotated relative to each other. Upon such rotation, the inner catheter 9 is also rotated relative to the outer catheter 7 around a rotation axis 17 parallel to the longitudinal direction 15.

[0078] The handle 5 may be used for pushing the outer and inner catheters 7, 9 along vessels of the patient towards an implantation site for example within a heart chamber. During such procedure, the outer catheter 7 being implemented as a steerable catheter may be steered using a steering mechanism 37 including a steering knob provided at the first handle component 11. Upon having arrived at the implantation site, the IMD 3 held at a distal end 27 of the inner catheter 9 may then be suitably fixed to adjacent tissue before deploying its deployable electrode 57 and pushing it deep into the tissue, as will be described in further detail below e.g. with reference to Figs. 7(A) - (C).

[0079] The handle 5 comprises two handle half shells housing internal components of the handle 5. The second handle component 13 forming a deployment actuator tracks through such handle half shells. Due to structural and functional characteristics of the first and second handle components 11, 13 and possibly of their handle half shells, a movement of the deployment actuator may be limited for a variety of purposes including controlling a linear translation as well as a rotational motion of the two handle components 11, 13 and the outer and inner catheters 7, 9 attached thereto.

[0080] At a distal end 39 of the outer catheter 7, a protector cup 41 is arranged (see e.g. Fig. 4). The protector cup 41 has a wider diameter compared to the outer catheter 7 such as to enable accommodating the IMD 3 therein. Embedded electrodes 43 are arranged at an outer surface of the protector cup 41 (see e.g. Fig. 5). Such embedded electrodes 43 are electrically connected to a circuitry comprised in or connected to the catheter arrangement 1 and enable a mapping capability with which electric characteristics of tissue contacted by the protector cup 41 may be evaluated.

[0081] 24.190P-WO / 28.01.2026Furthermore, at the distal end 27 of the inner catheter 9, an alignment torquer 29 is arranged (see e.g. Fig. 4). The alignment torquer 29 comprises a geometry including for example a recess 30 such as a slit via which the alignment torquer 29 may cooperate and engage with an engagement structures 31 formed for example by the hitch 63 provided at the proximal end 33 of the IMD (see Fig. 1(A)). Accordingly, using the alignment torquer 29, a rotation of the inner catheter 9 may be transmitted to the engagement structure 31 at the IMD 3 in order to thereby actuate of the deployment mechanism 53.

[0082] Specifically, the inner catheter 9 is configured for transmitting a substantial torque of for example at least 4 N-cm between its proximal end attached to the second handle component 11 and its distal end 27 attached to the alignment torquer 29. For such purpose, the inner catheter 9 may comprise for example a hollow tube structure 19 as exemplarily shown in Fig. 6. Such hollow tube structure 19 may be formed with or reinforced with a braided wire structure 21. Such braided wire structure 21 generally comprises one or plural layers of wires 22 arranged in a helical configuration. The wires 22 may be made from metal or another highly mechanically loadable material. The hollow tube structure 19 encloses an inner lumen 25.

[0083] A tether 23 may extend through such inner lumen 25 and may be longitudinally displaced relative to the inner catheter 9. A distal end of such tether 23 may be attached to an eye 69 included in the hitch 63 at the proximal end 33 of the IMD 3. If needed during an implantation procedure, using such tether 23, the IMD 3 may be retracted towards the catheter arrangement 1 and its protector cup 41.

[0084] Furthermore, plural fluoroscopically visible markers 35 are arranged at the inner catheter 9 such as to enable visualising a rotation motion of the inner catheter 9 in fluoroscopy images.

[0085] Finally, steps of a procedure for fixing the IMD 3 at tissue at an implantation site and then extending its deployable electrode deep into the tissue will be described with reference to Figs. 7(A) - (C).

[0086] Initially, the IMD 3 is accommodated within the protector cup 41. Upon having reached the implantation site and the distal end of the protector cup 41 being positioned adjacent to tissue such as myocardial tissue in a heart chamber, the second handle component 13 is linearly pushed in the distal direction 61 towards the first handle component 11. Thereby, the inner catheter 9 is translated relative to the outer catheter 7 in the distal direction 61 and the IMD 3 held at the distal end of the

[0087] 24.190P-WO / 28.01.2026inner catheter 9 is pushed out of the protector cup 41 arranged at the distal end of the outer catheter 7.

[0088] Upon being ejected from the protector cup 41, the tines 59 forming the fixation mechanism 49 are released. These tines 59 have initially been included within the protector cup 41 in an elastically deformed extended configuration and may, upon being released, relax into their predefined curved configuration. Thereby, the first tines 59 may fix the distal part 51 of the housing 47 of the IMD 3 to the adjacent tissue (not shown in the figures).

[0089] Finally, upon the IMD 3 being fixated with its distal part 51 in such manner, the second handle component 13 is rotated relative to the first handle component 11 around the rotation axis 17. Thereby, the inner catheter 9 is rotated and this rotation is transmitted via the alignment torquer 29 to the hitch 63 arranged at the proximal part 65 of the housing 47. As this hitch 63 and proximal part 65 form part of the deployment mechanism 53, the deployment mechanism 53 may be actuated by the induced rotation and may deploy the deployable electrode 57 of the electrode arrangement 55 accordingly. The rotation may be continued until the deployable electrode 57 is extended deep into the adjacent tissue such as to enable inducing pacing pulses via the electrode 57 for conduction system pacing.

[0090] In the following paragraphs, possible features, characteristics and advantages of embodiments of the electrode arrangement presented herein shall be described once more with a different wording:

[0091] As a short introductory summary, the present application relates inter alia to a conduction system leadless pacemaker delivery catheter. This catheter design utilizes a two-step deployment process, the first being e.g. a linear tine deployment and the second being a rotational electrode deployment. This solution allows e.g. for a pacemaker that combines the benefits of conduction system pacing with the benefits of leadless pacing to be implanted seamlessly into a patient anatomy. This will allow patients to have physiological pacing without the risk of infection, discomfort, mobility restrictions, or failure risks of a transvenous pacemaker. Additionally, the catheter provides a streamlined and optimized approach for implanting conduction system pacemakers.

[0092] First, some technical and / or medical background information shall be given as follows:

[0093] Conduction system pacing (CSP) is emerging as a form of cardiac resynchronization for patients who are displaying signs of heart failure and reduced ejection fraction. CSP involves placing a

[0094] 24.190P-WO / 28.01.2026transvenous pacing lead into the septum of the heart either at the HIS Bundle (HB) or within the Left Bundle Branch (LBB). By targeting the conduction system directly, rather than pacing the myocardium of the ventricle, there is a reduction in activation time and improved synchrony between the right and left ventricles. This is more physiologic for the patient and shows a reduction of adverse clinical outcomes in patients with ventricular pacing requirements >20% in comparison to standard RV pacing.

[0095] CSP leads are implanted into the heart with a delivery sheath. These sheaths often have three dimensional curves and shapes that allow for the lead to be positioned on the intraventricular septum and then tunneled into the septum to reach the conduction system (HB or LBB).

[0096] Implantable leadless pacemakers (ILPs) have also become an emerging technology that combines the lead and the implant into a single entity for implant directly into the heart. This offers a means for eliminating discomfort experienced by the presence of a large can residing within the patient’s chest while offsetting lead-based mobility restrictions. ILPs also eliminate lead-based transvenous infection pathways to the myocardium and other lead failures that can be present with transvenous pacing. Current ILP technology can only accomplish traditional right ventricle myocardium pacing due to the limitations of the electrode placement and device fixation being only in the myocardium of the right atrium or ventricle.

[0097] ILPs require specific delivery catheters that allow for the ILP to be delivered into the RV, positioned on the heart wall at the desired location, and fixated via a tines or helix.

[0098] The approach outlined in this disclosure details, inter alia, an ILP delivery catheter that implants an ILP capable of CSP.

[0099] Next, drawbacks of known solutions shall be described as follows:

[0100] Transvenous CSP (LBB or HB pacing) carries risk of the patient developing an infection along the lead pathway that goes directly into the heart. Transvenous leads also risk mechanical failures such as fractures. The transvenous pacemaker resides in the patient’s chest which can cause physical and / or emotional discomfort and the transvenous leads can limit patient mobility. Additionally, some patients have contraindications for transvenous leads.

[0101] 24.190P-WO / 28.01.2026ILPs are currently limited to Right Atrial (RA) or Right Ventricular (RV) myocardial pacing and cannot reach the conduction system of the heart to perform CSP. This is due to the limitation of the depth of the pacing electrode, which is controlled by the fixation mechanism on the ILP. Some ILPs are fixated into the heart with tines that hook into the myocardium, the depth not able to be controlled by the physician. Other ILPs have a helical fixation. The helix is a fixed length not long enough to reach the conduction system. Even if the helix were extended to be long enough to reach the conduction system, it likely would not be stable enough to fix the body of the ILP securely into the septum to provide safe long-term fixation. Since ILPs cannot accomplish CSP, patients who require >20% ventricular pacing are at risk for increased left ventricular activation time, reduced ejection fraction, and pacing induced heart failure.

[0102] There is a variety of drawbacks to a transvenous lead delivery procedure. E.g, transvenous lead delivery sheaths and leads were not originally designed to implant leads into the conduction system. Common drawbacks include:

[0103] • Low torque transmission in the lead: The ratio between the helix revolutions to input revolutions has been reported to be less than 1:2. This results in an inefficient procedure. In addition, the torque transmission is highly variable, so the user does not have a good way to correlate actual helix deployment from input revolutions.

[0104] • Breakout torque: Occasionally the torque will build up in the lead and release suddenly causing uncontrolled torque release in the helix. This can cause the lead to perforate the septum and enter the LV, which is undesired.

[0105] • Difficulty holding the position during implantation: Many physicians complain that the delivery sheath cannot maintain the desired position during the lead deployment. This adds time and complexity to the procedure and can result in lead deployment in unintended locations.

[0106] • Lack of support in delivery sheaths: Physicians also report they require more back support for the lead implantation than the existing delivery sheaths provide.

[0107] The limitation to ILP delivery catheters is that they currently are designed to deploy with one deployment actuation to fixate the tines or helix into the RV or RA myocardium. The pacing electrode remains on or relatively close to the surface and does not penetrate deeply enough to pace the conduction system.

[0108] A goal of the solution presented in this disclosure is, inter alia, to implant a leadless conduction system pacemaker with a tine-based fixation and pacing electrode that is advanced into the septum with a rotational actuation. This will allow users to have efficient tools and streamlined procedure

[0109] 24.190P-WO / 28.01.2026steps for conduction system pacemaker implantation and patients to have physiological pacing without the discomfort, mobility restrictions, or failure risks of a transvenous pacemaker.

[0110] A delivery catheter presented herein is designed to implant e.g. leadless conduction system pacemakers that utilize both a tine-based fixation element and a rotational element. Concepts of such leadless conduction system pacemakers including concepts for leadless conduction system pacing (LCSP) devices with tine based fixation and an extendible / retractable pacing electrodes have been presented in prior applications of the applicant. For example, in a first concept, a leadless pacemaker (LP) may have two components. One component, the tine sleeve, contains tines that fixate in the myocardium. The other component is the main IPG housing that contains the pacing electrode on an electrode extension that is deployed into the intraventricular septum by rotating the main IPG (internal pace generator) body relative to the tine sleeve that is fixed in the tissue. Another concept houses a flexible electrode extension in the header of the device (that also contains the tines) in a coiled configuration and as the main body of the device is rotated, the flexible electrode extension uncoils into a straight configuration that is deployed into the intraventricular septum to access the conduction system.

[0111] Both these concepts are implanted with a two-step process. The first step being deploying the tines to be fixated in the myocardium and the second step being deploying the pacing electrode into the intraventricular septum to reach the conduction system.

[0112] The present approach provides a catheter that accomplishes both actuations. One form factor of the catheter handle is shown in Figure 2. A breakdown of the components is shown in Figure 3 and Figure 4. The catheter contains a steerable outer catheter with a protector cup on the distal end that sheaths the device during navigation and implantation. There is also an inner catheter with an alignment torquer that mates to the hitch of the IPG. The inner catheter could be made of a polymer, coiled wire, or laser cut tube and is capable of both linear deployment and rotational torsion and therefore must have enough column strength and torque resistance. The geometry of the alignment torquer is such that it mates to the distal side of the IPG so it can both push, pull, and rotate the IPG. This can be accomplished through a slot in the alignment torquer that accepts the geometry of the hitch. It also serves to provide a smooth transition between the catheter and the IPG so the IPG can be recaptured and repositioned by the protector cup without catching. The alignment torquer also has a fluoroscopically visible marker in it to allow for rotation to be visualized on fluoroscopy during the procedure.

[0113] 24.190P-WO / 28.01.2026The proximal end of the steerable catheter terminates in a steering mechanism that provides deflection to the catheter to allow for navigation of the IPG to an appropriate location in the patient anatomy that will allow for conduction system pacing. The proximal end of the inner catheter passes through a valve in the steering mechanism and then terminates in the IC deployment actuator. The deployment actuator both pushes the inner catheter for the initial tine deployment of the device and then rotates the inner catheter to extend the pacing electrode. These steps can be seen in Figure 5.

[0114] Through the lumen of the inner catheter is a tether comprised of a cable, wire, or suture that keeps the IPG coupled to the catheter during navigation and deployment until the tines are fixated in the myocardium and the pacing electrode deployed in the intraventricular septum.

[0115] To reposition the device, the actuation steps can be reversed: couple the device with the catheter via the tether to seat it into the alignment torquer, rotate the deployment actuator in the reverse direction to retract the pacing electrode, then pull back to resheath the device into the protector cup. The tether will be mated to the inner catheter deployment actuator in a way that it rotates in unison to avoid entanglement of the tether.

[0116] The internal components of the handle may be all housed in two handle half shells that the deployment actuator tracks through. The handle half shells may contain mating features to limit the movement of the deployment actuator for a variety of purposes including controlling the linear translation and the rotational movement of the inner catheter, locking the deployment actuator in place to prevent accidental movement, and haptic pauses to provide the user with feedback for each step.

[0117] The whole system may contain flush ports that fdl the inner catheter with saline and / or contrast, that will then fdl the steerable catheter with fluid to make the whole system flushable and deliver contrast to the distal tip of the catheter for visualization purposes during the implantation procedure.

[0118] The catheter may also include embedded electrodes in the distal end of the protector cup to allow for mapping capabilities through the catheter as shown in Figure 6. The electrodes can be embedded as a flexible circuit board (such as liquid crystal polymer) or individual electrodes (such as Pt-Ir) with wires. The wires or circuit will terminate at the proximal end of the handle in a connector that will allow physicians to pace map the intraventricular septum prior to implanting the LCSP device to ensure they are in a good location to access the conduction system.

[0119] 24.190P-WO / 28.01.2026Summarized, the approach presented herein relates to:

[0120] 1. A catheter that deploys a leadless pacemaker that has tine fixation and a pacing electrode that extends into the intraventricular septum to reach the conduction system.

[0121] 2. An inner catheter that has sufficient column strength and torque transmission to allow for linear actuation and rotational actuation.

[0122] 3. An alignment torquer that mates to the LP to provide a coupling feature to allow for torque translation from the inner catheter to the LP and has a fluoroscopically visible marker to allow for visualization of rotation under fluoroscopy.

[0123] 4. A deployment actuator that controls the actuation of the inner catheter with a push and a rotate movement.

[0124] 5. A catheter that can reposition the LP by reversing the deployment steps.

[0125] The presented approach contains a conduction system leadless pacemaker delivery catheter that is capable of deploying tine-based fixation of the LP and telescoping a pacing electrode into the intraventricular septum to pace the conduction system (eg. His bundle or left bundle branch / left bundle branch area). This solution allows for the benefits of leadless pacing and conduction system pacing to be combined. The two-step mechanism allows for rapid deployment of tines to provide fixation for the leadless pacemaker and then a separate step that allows the user to advance the pacing electrode into the tissue. This method means the pacing electrode can be delivered to any incremental length to accommodate a variety of patient anatomy and septal thicknesses. The pacing electrode can also be advanced iteratively to allow for continual pacing and IEGM readings during deployment to allow physicians to see a morphology change in the signal and confirm conduction system pacing capture as well as monitor impedance changes to indicate a septal perforation of the pacing electrode.

[0126] The present approach utilizes an inner catheter to both drive the LP forward to deploy tines as well as rotate the LP to advance a pacing electrode. This inner catheter will have closer to a 1:1 torque translation ration, providing a controlled rotational deployment of the pacing electrode. This is an improvement over current solutions for CSP with transvenous leads where there is poor torque translation and insufficient back support for efficient lead implantation.

[0127] This catheter could also be fitted to do extractions of the LP by removing the tether system and inserting a snare with one or more loops. That will allow for the hitch of the LP to be captured and seated in the alignment torquer to disengage the electrode extension via rotation and advance the protector cup over the LP by retracting the deployment slider to disengage the tines from the tissue and safely remove the system from the patient anatomy.

[0128] 24.190P-WO / 28.01.2026Finally, it should be noted that the term “comprising” does not exclude other elements or steps and the “a” or “an” does not exclude a plurality. Also elements described in association with different embodiments may be combined. It should also be noted that reference signs in the claims should not be construed as limiting the scope of the claims.

[0129] 24.190P-WO / 28.01.2026List of Reference Numerals

[0130] I catheter arrangement

[0131] 3 implantable medical device

[0132] 5 handle

[0133] 7 outer catheter

[0134] 9 inner catheter

[0135] I I first handle component

[0136] 13 second handle component

[0137] 15 longitudinal direction

[0138] 17 rotation axis

[0139] 19 hollow tube structure

[0140] 21 braided wire structure

[0141] 22 wire

[0142] 23 tether

[0143] 25 inner lumen

[0144] 27 distal end of inner catheter

[0145] 29 alignment torquer

[0146] 30 recess

[0147] 31 engagement structure

[0148] 33 proximal end of IMD

[0149] 35 fluoroscopically visible marker

[0150] 37 steering mechanism

[0151] 39 distal end of the outer catheter

[0152] 41 protector cup

[0153] 43 embedded electrode

[0154] 45 medical device implantation arrangement

[0155] 47 housing

[0156] 49 fixation mechanism

[0157] 51 distal part of the housing

[0158] 53 deployment mechanism

[0159] 55 electrode arrangement

[0160] 57 deployable electrode

[0161] 59 tine

[0162] 61 distal direction

[0163] 24.190P-WO / 28.01.2026hitch

[0164] proximal part of the housing

[0165] threading

[0166] eye

[0167] 24.190P-WO / 28.01.2026

Claims

Claims1. A medical device implantation arrangement (45) comprising:a catheter arrangement comprising:a handle (5),an elongate outer catheter (7), andan elongate inner catheter (9) extending within the outer catheter (7),wherein the handle (5) comprises a first handle component (11) mechanically coupled with the outer catheter (7) and a second handle component (13) mechanically coupled with the inner catheter (9),wherein the second handle component (13) is linearly displaceable relative to the first handle component (11) such as to displace the inner catheter (9) relative to the outer catheter (7) along a longitudinal direction (15), andwherein the second handle component (13) is rotatable relative to the first handle component (11) such as to rotate the inner catheter (9) relative to the outer catheter (7) around a rotation axis (17) parallel to the longitudinal direction (15);and an implantable medical device (3) held at a distal end (27) of the inner catheter (9).

2. The medical device implantation arrangement (1) of claim 1,wherein the inner catheter (9) is configured for transmitting a torque of at least 3 N-cm between its proximal end and its distal end upon being rotated around the rotation axis (17).

3. The medical device implantation arrangement (1) of claim 1,wherein the inner catheter (9) has a hollow tube structure (19).

4. The medical device implantation arrangement (1) of claim 3,wherein the inner catheter (9) is one of formed with and reinforced with a braided wire structure (21) and / or hypotube.

5. The medical device implantation arrangement (1) of claim 3,wherein an elongate tether (23) extends through an inner lumen (25) enclosed by the hollow tube structure (19).

6. The medical device implantation arrangement (1) of claim 1,24.190P-WO / 28.01.2026wherein a distal end (27) of the inner catheter (9) is provided with an alignment torquer (29) which is configured for engaging with an engagement structure (31) provided at a proximal end (33) of the implantable medical device (3) with a form fit between the alignment torquer (29) and the engagement structure (31) such as to transmit a torque between the inner catheter (9) and the implantable medical device (3) upon the inner catheter (9) being rotated around the rotation axis (17).

7. The medical device implantation arrangement (1) of claim 1,wherein the inner catheter (9) is provided with a fluoroscopically visible marker (35) which is configured and arranged such as to enable visualizing a rotation motion of the inner catheter (9) in fluoroscopy imaging.

8. The medical device implantation arrangement (1) of claim 1,wherein the outer catheter (7) is steerable and the first handle component (11) is provided with a steering mechanism (37) for steering the outer catheter (7).

9. The medical device implantation arrangement (1) of claim 1,wherein a distal end (39) of the outer catheter (7) is provided with a protector cup (41) for accommodating the implantable medical device (3),wherein the protector cup (41) comprises embedded electrodes (43) configured for providing a mapping capability.

10. The medical device implantation arrangement (45) of any of the previous claims, wherein the implantable medical device (3) comprises:- a housing (47),- a fixation mechanism (49) for fixing at least a distal part (51) of the housing (47) at a patient’s tissue,- a deployment mechanism (53) being rotatable relative to the distal part (51) of the housing (47),- an electrode arrangement (55) including a deployable electrode (57) which cooperates with the deployment mechanism (53) such as to one of extend the electrode (57) beyond the housing (47) and retract the electrode (57) towards the housing (47) upon the deployment mechanism (53) being rotated relative to the distal part (51) of the housing (47).24.190P-WO / 28.01.202611. The medical device implantation arrangement (45) of claim 10,wherein the fixation mechanism (49) comprises plural elongate bendable tines (59) arranged at the distal part (51) of the housing (47) and being configured for fixing the housing (47) by engaging the tines (59) with the patient’s tissue.

12. A method for implanting an implantable medical device (3), the method comprising:providing a medical device implantation arrangement (45) according to claim 1 with the implantable medical device (3) being initially accommodated within a protector cup (41) at a distal end (39) of the outer catheter (7) ,transferring the implantable medical device (3) to an implantation site adjacent to a patient’s tissue,linearly displacing the second handle component (13) relative to the first handle component (11) to thereby displace the inner catheter (9) relative to the outer catheter (7) in a distal direction (61) such as to eject the implantable medical device (3) from the protector cup (41) and fix at least a distal part (51) of a housing (47) of the implantable medical device (3) at the patient’s tissue, androtating the second handle component (13) relative to the first handle component (11) to thereby rotate the inner catheter (9) relative to the outer catheter (7) such as to actuate a deployment mechanism (53) of the implantable medical device (3) such as to successively extend a deploy able electrode (57) of the implantable medical device (3) beyond the housing (47) and into the patient’s tissue.24.190P-WO / 28.01.2026

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