Implantable medical device, and method and implanting tool for implanting an implantable medical device

Abstract

A system comprising an implanting tool and an implantable medical device (20) is described. The implantable medical device (20) comprises: a first module (22) having a first distal section (26) for being implanted into a tissue (50) of a patient, a first proximal section (28) coupled to the first distal section (26) at a proximal end of the first distal section (26), a first stimulation electrode (29) at the first distal section (26) facing away from the first proximal section (28), and a first electrical contact (30) at the first proximal section (28) facing away from the first distal section (26), wherein the first stimulation electrode (29) is electrically coupled to the first electrical contact (30); and a second module (24) having a second distal section (38) nondestructive decoupleable coupled to the first proximal section (28) of the first module (22), a second proximal section (39) being coupled to a proximal end of the second distal section (38) facing away from the first module (22), and a second electrical contact (42) at the second distal section (38), wherein the first electrical contact (30) and the second electrical contact (42) are in electrical contact with each other and wherein the first electrical contact (30) and the second electrical contact (42) are formed and arranged such that they are electrically separated from each other when the first module (22) and the second module (24) are decoupled from each other.

Description

[0001] Applicant: BIOTRONIK SE & Co. KG

[0002] Date: 13.11.2025

[0003] Our Reference: 23.184P-WO

[0004] IMPLANTABLE MEDICAL DEVICE, AND METHOD AND IMPLANTING TOOL

[0005] FOR IMPLANTING AN IMPLANTABLE MEDICAL DEVICE

[0006] The present invention refers to an implantable medical device, and to a method and an implanting tool for implanting the implantable medical device.

[0007] The Implantable Medical Device (IMD) may be an implantable intracardiac device, such as e.g. an implantable intracardiac pacemaker. Active or passive intracardiac medical devices, for example implantable intracardiac pacemakers (also known as leadless or intracardiac pacemakers), are well known miniaturized medical devices which are entirely implanted into a heart’s chamber or atrium. Intracardiac pacemakers are used for patients who suffer from a bradycardia, that is if a heart that beats too slow to fulfil the physiological needs of the patient. Intracardiac pacemakers apply electrical stimulation in the form of pulses to the heart in order to generate a physiologically appropriate heartrate and / or in the form of shocks for cardioversion or defibrillation in order to restore a more normal heart rhythm. Alternative or additional functions of intracardiac devices comprise providing other electrical or electromagnetic signals to the heart or its surrounding tissue, sensing electrical or electromagnetic signals or other physiological parameters of the heart and / or its surrounding tissue.

[0008] The IMDs, in particular the leadless pacemakers comprise an energy source for supplying electric energy to the electrodes. When the energy source has to be changed, e.g. because of battery exhaustion, the corresponding IMD has to be removed from the tissue of the patient, the energy source has to be changed or loaded and the IMD has to be implanted again. However, there are many applications in which the IMD cannot be positioned at the same implantation site as before, because an anchor element of the IMD, which couples the IMD to the tissue, may hurt the tissue and the hurt may become too severe, when the IMD is arranged at the same implantation site two or more times. Therefore, the reimplanted IMD may be arranged at another implantation site of the tissue. However, depending on the application there might not be many appropriate implantation sites for arranging the IMD at the tissue. For example, conventional leadless pacemakers cannot be implanted in a LBBAP (Left Bundle Branch Area Pacing) position. The known concepts for IMDs in the LBBAP position cannot reuse the implantation site when an energy source of the IMD is changed, e.g. after an exhaustion of the energy source. This represents a significant limitation of these concepts, as the possible suitable implantation sites for LBBAP therapy are very limited.

[0009] Accordingly, there is a need for an IMD which may be used at the same implantation site for a long period of time, e.g. for a duration longer than the lifetime of an energy source of the IMD, and / or which may be used at the same implantation site after changing and / or loading an energy source of the IMD. Further, there is a need for a method for implanting the implantable medical device into the body of the patient. Furthermore, there is a need for an implanting tool for implanting the implantable medical device.

[0010] The above problem is solved by the subject matter of the independent claims. Advantageous embodiments are given in the dependent claims and are visualized in the figures.

[0011] An aspect relates to an Implantable Medical Device (IMD), in particular as part of a system comprising an implanting tool and an IMD, in particular a second module of an IMD. The implantable medical device may comprise: a first module having a first distal section for being implanted into a tissue of a patient, a first proximal section coupled to the first distal section at a proximal end of the first distal section, a first stimulation electrode at the first distal section facing away from the first proximal section, and a first electrical contact at the first proximal section facing away from the first distal section, wherein the first stimulation electrode is electrically coupled to the first electrical contact; and a second module having a second distal section nondestructive coupleable to the first proximal section of the first module, a second proximal section being coupled to a proximal end of the second distal section facing away from the first module, and a second electrical contact at the second distal section, wherein the first electrical contact and the second electrical contact are in electrical contact with each other and wherein the first electrical contact and the second electrical

[0012] 23.184P-WO / 13.11.2025 contact are formed and arranged such that they are electrically separated from each other when the first module and the second module are decoupled from each other. In an embodiment the second module may be nodestructive decoupleable coupled to the first module. The inventive system may comprise at least the implanting tool and a second module of an IMD comprising a first and a second module.

[0013] An aspect relates to a method for implanting the implantable medical device into a body of the patient. The method comprises: implanting the first module into the tissue of the patient by a conventional implanting tool; testing whether the first module is properly arranged at the tissue of the patient and / or whether the first module functions as intended for its use by applying electric energy to the first stimulation electrode of the first module via the conventional implanting tool and the first electrical contact; decoupling the conventional implanting tool from the first module and the first electrical contact when the first module is properly arranged at the tissue of the patient and / or when the first module functions as intended for its use; and mechanically and electrically coupling the second module to the first module. The electric energy may be applied to the first stimulation electrode by coupling the first stimulation electrode to an electric potential of an external energy source via the first electrical contact and an electric line of the conventional implanting tool. The second module may be coupled to the first module by another implanting tool, as described in the following.

[0014] An aspect relates to the implanting tool for implanting the implantable medical device, in particular the second module of the implantable medical device. The implanting tool comprises: a tubular body surrounding a cavity for accommodating the implantable medical device, e.g. the second module of the implantable medical device, the tubular body having a distal end, a proximal end and a lateral surface extending from the distal end to the proximal end, with a longitudinal axis of the tubular body extending from the distal end to the proximal end; a first channel having a first end of the first channel coupled to an outside of the lateral surface, with the first channel laterally extending away from the lateral surface and then extending back towards the longitudinal axis beyond the distal end of the tubular body, wherein the lateral surface comprises a first surface opening through which the first channel opens out into the cavity at the first end of the first channel; a second channel having a first

[0015] 23.184P-WO / 13.11.2025 end of the second channel coupled to the outside of the lateral surface, with the second channel laterally extending away from the lateral surface and then extending back towards the longitudinal axis beyond the distal end of the tubular body, wherein the lateral surface comprises a second surface opening through which the second channel opens out into the cavity at the first end of the second channel; a third channel having a first end of the third channel coupled to the outside of the lateral surface, with the third channel laterally extending away from the lateral surface and then extending back towards the longitudinal axis beyond the distal end of the tubular body, wherein the lateral surface comprises a third surface opening through which the third channel opens out into the cavity at the first end of the third channel; a fourth channel having a first end of the fourth channel coupled to the outside of the lateral surface, with the fourth channel laterally extending away from the lateral surface and then extending back towards the longitudinal axis beyond the distal end of the tubular body, wherein the lateral surface comprises a fourth surface opening through which the fourth channel opens out into the cavity at the first end of the fourth channel, wherein the first to fourth channels are bent back towards the longitudinal axis such that a first channel opening at a second end of the first channel, a second channel opening at a second end of the second channel, a third channel opening at a second end of the third channel and a fourth channel opening at a second end of the fourth channel face each other beyond the distal end of the tubular body, and wherein the first to fourth surface openings and the first to fourth channels are distributed around a circumference of the tubular body such that the first channel is arranged between the second channel and the fourth channel and opposite to the third channel; a first wire (e.g. pull wire) extending through the tubular body from the proximal end of the tubular body through the first surface opening, through the first channel, out of the first channel opening into the second channel opening, through the second channel, through the second surface opening and back to the proximal end of the tubular body, wherein the first wire is relaxed in a first state of the first wire and forms a first loop between the first channel opening and the second channel opening; and a second wire (e.g. pull wire) extending through the tubular body from the proximal end of the tubular body through the third surface opening, through the third channel, out of the third channel opening into the fourth channel opening, through the fourth channel, through the fourth surface opening and back to the proximal end of the tubular body, wherein the second wire is relaxed in a first state of the second wire and forms a second loop between the third channel

[0016] 23.184P-WO / 13.11.2025 opening and the fourth channel opening, wherein the first loop and the second loop overlap each other such that they surround a common space for accommodating at least a part of the implantable medical device, wherein the common space has a first size in lateral direction in the first states of the first and second wires and wherein the common space has a second size in lateral direction smaller than the first size when the first wire and the second wire are in corresponding second states in which the first wire and the second wire are strained.

[0017] The IMD, e.g. a leadless cardiac pacemaker or intracardiac pacemaker, may be implanted in an LBBAP (Left Bundle Branch Area Pacing) configuration, wherein the pacing system is divided into the at least two modules. A stimulation site may be the left leg area in the deep ventricular septum. The stimulation electrode of the first module may be used for stimulating the myocardium. The modularity allows that the module containing the energy source, e.g. the second module, to be exchanged without having to explant the module with the pacing or stimulation electrode, e.g. the first module. In this way, the stimulation site can be reused in particular for LBBAP stimulation after changing the energy source.

[0018] The IMD may be a pacemaker, e.g. a cardiac pacemaker, e.g. a intracardiac pacemaker or leadless cardiac pacemaker. The IMD may be in a first state when the first module is coupled to the second module. The IMD may be in a second state when the first module is decoupled from the second module. The IMD may be in its first state when the IMD is already implanted within the patient's body as intended for its use. The IMD maybe in the second state during the implementation process. In particular, the first module decoupled from the second module may be implanted first and the second module may be implanted and coupled to the first module afterwards.

[0019] The first module may comprise a first housing and the second module may comprise a second housing. The first housing and / or the second housing and as such the first and, respectively second module each may have a cylindrical shape. In this case, the IMD may have a cylindrical shape consisting of the cylindrical first module and the cylindrical second module. The first module, in particular the first housing, may be fully or partially flexible and / or may comprise or may consist of a flexible material. The flexible material of the first housing may consist of or may comprise a thermoplastic elastomer, in particular

[0020] 23.184P-WO / 13.11.2025 polyurethane or polyether block amide or silicone. The first module may also have a rigid section, which may consist of metals, like Platinum, MP35N, stainless steel or plastics like polyether ether ketone (PEEK), liquid crystal polymer (LCP), polyurethane (PU), polypropylene (PP), polycarobonate (PC), polyethylene (PE), polyamide (PA), Polytetrafluoroethylene (PTFE). The second module, in particular the second housing, may comprise or may consist at least in part of a rigid material. The rigid material of the second housing may consist of or may comprise an inert material, in particular titanium, platinum (Pt) or platinum-iridium (Pt / Ir), nickel-cobalt, stainless steel, PEEK, LCP, PU, PP, PC, PE, PA, PTFE. Alternatively, the second module, in particular the second housing, may comprise at least in part a flexible material. For example, the second module may be flexible in its middle or distal section. The flexible material of the second module may correspond to the flexible material of the first module. The first housing and the second housing may comprise or may be made of a material which does not corrode when having contact to one or more body liquids of the patient, e.g. a material which is inert to the body.

[0021] That the first electrical contact and the second electrical contact are formed and arranged such that they are in electrical contact with each other may mean that they physically touch each other when they are in electrical contact with each other, in particular in the first state. The first electrical contact and the second electrical contact may be configured as unipolar electrical connection or as a bipolar electrical connection. The first electrical contact of the first module and the second electrical contact of the second module may form a common contact device which is designed to establish permanent electrical contact of the first module with the second module after the implantation of the first module and after coupling the second module to the first module. The common contact device is also designed to be separated again without the first module having to be explanted, i.e. without removing it from its myocardial anchorage. The first and second electrical contacts of the contact device each may be made of the same or an electrochemically comparable combination of materials, so that corrosion is sufficiently excluded even in contact with body fluids.

[0022] The first stimulation electrode may be at least partly exposed to surroundings of the implantable medical device. The first stimulation electrode may be arranged for electrically stimulating the tissue of the patient. For example, a stimulation site at which the IMD may

[0023] 23.184P-WO / 13.11.2025 be implanted may be the left bundle brunch area in the deep ventricular septum. The first stimulation electrode may be electrically coupled to the first electrical contact by a first electrically conductive element, e.g. a wire, lead or other appropriate conductor.

[0024] The first module may comprise a first anchor element at the first distal section, e.g. at a distal end of the first distal section. The first anchor element may at least in part be exposed to the surroundings of the implantable medical device. The first anchor element may be configured for permanently fixing the first module to the tissue of the patient, e.g. in the myocardium. The first anchor element may be helically shaped and / or may comprise a sharp tip at a distal end of the first anchor element. Optionally, the first anchor element is configured as the first stimulation electrode or comprises the first stimulation electrode.

[0025] The second module may comprise a second anchor element at the second distal section, e.g. at a distal end of the second distal section. The second anchor element may at least in part be exposed to the surroundings of the IMD. The second anchor element may be configured for fixing the second module to the tissue of the patient. The second anchor element may fix the second module to or in the myocardial tissue. The second anchor element may comprise two or more, e.g. four, tines, as they are known in the art. Alternatively or in addition, the second anchor element may comprise a helix having a inner diameter larger than the outer diameter of the first module. Such helical anchors or screws are known in the art.

[0026] A control unit for controlling the implantable medical device may be arranged within the first module or within the second module. In any case, the control unit may be configured for stimulating the patient’s tissue via the first stimulation electrode.

[0027] The implanting tool may be used to implant an implant, such as the IMD, in particular a multi-part implant, as for example the modular IMD as described above and in the following. In particular, the implanting tool may be used to implant the second module of the IMD. In contrast, the first module may be implanted with a conventional implanting tool eventually having a removable, flexible extension referred to as lead body, e.g. by using a catheter technique. The flexible extension may also include a contact device for temporary contacting

[0028] 23.184P-WO / 13.11.2025 of the first module and thus may allow an electrical intraoperative measurement of heating signals.

[0029] The implanting tool may be or may comprise a catheter. The implanting tool may be used to explant the implant. The implanting tool may be used to manipulate the implant, e.g. by rotating the implant. The implanting tool may be mechanically coupled to the implant. For example, at least a part of the implant may be arranged within the tubular body of the implanting tool. In particular, when the first module of the IMD is already implanted, the second module of the IMD may be coupled to the first module by the implanting tool, wherein the second module may be accommodated within the tubular body during the coupling process.

[0030] The wires of the implanting tool form a centering device of the IMD. The wires of the implanting tool enable to center the implant or at least a part of the implant, e.g. the first proximal section and / or the pin, with respect to the tubular body. When the second module is arranged in the tubular body, the centering device allows the second module to be positioned centrally above the first electrical contact of the first module. Then, the first and second modules may be mechanically coupled to each other thereby closing the electrical contact of the contact device. For example, the part to which the second module may be centered may be arranged within the first and second loops in the first states of the wires. Then, the wires may be strained such that the loops get strained thereby automatically centering the tubular body with respect to the part. When the wires are in their strained second states, the loops are narrowed and the second module centrally arranged within the tubular body is automatically centered with respect to the part, for example such that the part lies on the longitudinal axis of the tubular body and / or the second module.

[0031] According to an embodiment, the first electrical contact and the second electrical contact are formed such that the first electrical contact is movable relative to the second electrical contact parallel to a distal direction without losing the electrical connection to each other when the first module is moved relative to the second module parallel to the distal direction. The possibility of the movement of the first electrical contact relative to the second electrical contact may contribute to compensate for different implanting depths. In particular, a depth

[0032] 23.184P-WO / 13.11.2025 in which the first module is implanted into the tissue may vary from patient to patient and / or from application to application. So, a position of the first electrical contact relative to the second electrical contact and a length of a contactable region of the first electrical contact may also vary from patient to patient and / or, respectively, from application to application. However, when the first electrical contact is movable relative to the second electrical contact, these differences may be compensated for.

[0033] According to an embodiment, the first electrical contact of the first module comprises an electrically conductive pin extending from the proximal end of the first distal section in proximal direction, the second distal section of the second module comprises a module recess extending from a distal end of the second distal section in the proximal direction, a second electrical contact of the implantable medical device is arranged within the module recess, and the pin is at least partly arranged within the module recess such that the pin is electrically coupled to the second electrical contact. Alternatively, the second electrical contact of the second module comprises the electrically conductive pin extending from a distal end of the second proximal section in distal direction, the first proximal section of the first module comprises the module recess extending from the proximal end of the first proximal section in the distal direction, and the pin is at least partly arranged within the module recess such that the second electrical contact is electrically coupled to the first electrical contact. The pin and the module recess as well as the electrical contact within the module recess may contribute to enable the movement of the first electrical contact relative to the second electrical contact. The pin and the module recess may form a plug-in contact. The proximal direction is a parallel to the distal direction wherein an orientation of the proximal direction is opposed to the distal direction. The common contact device may be designed in such a way that it can compensate for a different implantation depth of the first module. This may be realized by the pin being sufficiently long such that it may be contacted over a length of 0.1 mm tolO mm, e.g. of 1 mm to 7 mm, e.g. of 2 mm to 5 mm.

[0034] According to an embodiment, the second electrical contact comprises a contact recess in which the pin is at least partly arranged such that the pin at least partly extends through the contact recess. This may contribute to enable the movement of the first electrical contact relative to the second electrical contact in an easy way.

[0035] 23.184P-WO / 13.11.2025 According to an embodiment, the second electrical contact is ring-shaped, with the corresponding ring-shape surrounding the contact recess. The ring-shape of the second electrical contact providing the contact recess and the pin being arranged within the contact recess enable the relative movement between the first electrical contact and the second electrical contact parallel to the distal direction.

[0036] According to an embodiment, the second electrical contact comprises an elastic body. For example, the second electrical contact may consist of the elastic body. That the elastic body is elastic may mean in this context the elastic body comprises or consists of an elastic material or elastic components like coil or a combination of it. The elastic material may be rubber or silicon or a thermoplastic elastomer. For example, the second electrical contact may be made of a silicone body in which electrically conductive particles are embedded such that the second electrical contact is electrically conductive. Alternatively or additionally, that the elastic body is elastic may mean in this context that the elastic body has a stiffness from 5 N*mA2 to 120 N*mA2 , e.g. from 20 N*mA2 to 60 N*mA2. The elastic body may enable a relative movement of the pin with respect to the second module, in particular the second electrical contact, perpendicular to the distal direction. The elastic body may somehow introduce a certain degree of freedom when coupling the first module to the second module, because the elastic body may compensate for slight position variations between the first module and the second module because of its elasticity.

[0037] According to an embodiment, the implantable medical device comprises: a ring-shaped seal surrounding a seal recess, being arranged in distal direction between the second electrical contact and the first distal section of the first module, and being arranged in direction perpendicular to distal direction between the pin and the module recess such that the pin extends through the seal recess and that the ring-shaped seal is arranged between the pin and an inner wall of the module recess, wherein an outer diameter of the ring-shaped seal is formed with an interference fit to an inner diameter of the module recess and an outer diameter of the pin is formed with an interference fit to an inner diameter of the seal recess. The ring-shaped seal may contribute to hinder body liquids from entering the module recess beyond the ring-shaped seal and from coming into contact with the second electrical contact.

[0038] 23.184P-WO / 13.11.2025 According to an embodiment, the implantable medical device comprises: an energy source for supplying electric energy to the first stimulation electrode via the second electrical contact and the first electrical contact, the energy source being arranged within the second module and being electrically coupled to the second electrical contact. Arranging the energy source within the second module enables to easily exchange the energy source when it is empty by decoupling the second module from the first module, by removing the second module from the body of the patient and by exchanging or loading the energy source outside of the body of the patient. Then, the second module with the loaded or new energy source may be coupled to the first module again. During this whole procedure, the first module may be coupled with the tissue and may not be removed. This may contribute to the health of the patient, because the tissue does not have to be injured by removing the first module from the tissue or by replacing the first module at the tissue after loading or exchanging the energy source.

[0039] According to an embodiment, the implantable medical device comprises a second stimulation electrode being arranged at the second module and being electrically coupled to the energy source. The second stimulation electrode may be at least partly exposed to surroundings of the implantable medical device. The second stimulation electrode may be arranged for electrically stimulating the tissue of the patient, e.g. In cooperation with the first stimulation electrode. For example, the second stimulation electrode may be a counter electrode, e.g. an anode, for stimulation against the first stimulation electrode. The second stimulation electrode may be electrically coupled to the energy source by a second electrically conductive element, e.g. a conductive wire, lead, or any other appropriate conductor. Optionally, in in case of the second module comprising the second anchor element, the second anchor element may be configured as the second stimulation electrode or comprises the second stimulation electrode.

[0040] According to an embodiment, the second module comprises a housing, and at least a part of the housing is configured as the second stimulation electrode. This may contribute to keep the design of the implantable medical devices simple and thereby unsusceptible for any

[0041] 23.184P-WO / 13.11.2025 faults. The housing of the second module may be referred to as second housing, whereas the housing of the first module may be referred to as first housing in the following.

[0042] According to an embodiment, the implantable medical device comprises: a first part of a mechanical connection for mechanically connecting the first module to the second module, the first part being arranged at the proximal end of the first proximal section of the first module; and a second part of the mechanical connection, the second part being arranged at the distal end of the second distal section of the second module and being mechanically coupled to the first part, wherein the first part and the second part of the mechanical connection are configured such that first module is nondestructive decoupleable from the second module by mechanically decoupling the first part from the second part. The first part may comprise an external or internal thread and the second part may comprise a corresponding internal or, respectively, external thread such that the first and second modules may be screwed to each other by the corresponding external and internal thread.

[0043] According to an embodiment, the first part comprises the first electrical contact, and the second part comprises the second electrical contact. This may enable the movement of the first electrical contact relative to the second electrical contact parallel to the distal direction. In this context, the common contact device formed by the first and second electrical contacts may be a screw contact.

[0044] According to an embodiment, the implanting tool comprises a first stop-element and a second stop-element fixedly arranged at the first wire between the first channel opening and the second channel opening, wherein the first and second stop-elements are formed such that they cannot be pulled into the first and second channel openings thereby defining a minimal size of the first loop; and a third stop-element and a fourth-stop element fixedly arranged at the second wire between the third channel opening and the fourth channel opening, wherein the third and fourth stop-elements are formed such that they cannot be pulled into the third and fourth channel openings thereby defining a minimal size of the second loop. The stopelements may be arranged at the corresponding wires such that the wires being in the second states and having their minimal sizes may still be able to hold the part of the implantable medical device by a press fit between each other.

[0045] 23.184P-WO / 13.11.2025 It has to be understood that some features, technical effects and / or advantages of the present invention are described with respect to one of the above aspects only for conciseness reasons and that these features may easily be transferred to one or more of the other aspects in order to achieve the same or additional technical effects and / or advantages.

[0046] Fig. 1 shows a perspective, semi-cut view of an exemplary embodiment of an implantable medical device, in a first state of the implantable medical device.

[0047] Fig. 2 shows a perspective, semi-cut view of an exemplary embodiment of an implantable medical device, in a second state of the implantable medical device.

[0048] Fig. 3 shows a perspective view of a first step of a method for implanting a first module of the implantable medical device of figures 1 and 2.

[0049] Fig. 4 shows a perspective view of a second step of the method for implanting the first module of the implantable medical device of figures 1 and 2.

[0050] Fig. 5 shows a perspective view of a third step of the method for implanting the first module of the implantable medical device of figures 1 and 2.

[0051] Fig. 6 shows a perspective view of a fourth step of the method for implanting the first module of the implantable medical device of figures 1 and 2.

[0052] Fig. 7 shows a semi-transparent perspective view of an exemplary embodiment of an implanting tool in which a second module of the implantable medical device of figures 1 and 2 is arranged.

[0053] Fig. 8 shows a perspective bottom-view of an exemplary embodiment of a tubular body of the implanting tool of figure 7 and of the first module of the implantable medical device in a first state of the implanting tool.

[0054] 23.184P-WO / 13.11.2025 Fig. 9 shows a perspective bottom-view of the tubular body of the implanting tool of figure 7 and of the first module of the implantable medical device in a second state of the implanting tool.

[0055] Fig. 10 shows a perspective bottom -view of the tubular body of the implanting tool of figure 7 and of the first module of the implantable medical device in a third state of the implanting tool.

[0056] Fig. 11 shows a perspective bottom-view of the tubular body of the implanting tool of figure 7 and of the first module of the implantable medical device in a fourth state of the implanting tool.

[0057] Fig. 12 shows a perspective bottom -view of the implantable medical device of figures 1 and 2.

[0058] Fig. 13 shows a perspective bottom -view of another exemplary embodiment of the tubular body of the implanting tool of figure 7 and of the first module of the implantable medical device in the first state of the implanting tool.

[0059] Fig. 14 shows a perspective bottom -view of the tubular body of the implanting tool of figure 13 and of the first module of the implantable medical device in the second state of the implanting tool.

[0060] The figures are only schematic and not to scale. Same reference signs refer to same or similar features.

[0061] Fig- 1 shows a perspective, semi-cut view of an exemplary embodiment of an implantable medical device 20, in a first state of the implantable medical device 20. The implantable medical device 20 may be in the first state of the implantable medical device 20 when the first module 22 is already coupled to the second module 24. The implantable medical device 20 may be in its first state when the implantable medical device 20 is already implanted within the patient's body as intended for its use.

[0062] 23.184P-WO / 13.11.2025 The implantable medical device 20 comprises a first module 22 and a second module 24. The implantable medical device 20 may be a pacemaker, e.g. a cardiac pacemaker, in particular a leadless or intracardiac pacemaker. The implantable medical device 20 may be implanted in an LBBAP (Left Bundle Branch Area Pacing) configuration, wherein the pacing system of the implantable medical device 20 is divided into the at least two modules 22, 24.

[0063] The first module 22 has a first distal section 26 for being implanted into a tissue 50 of a patient, a first proximal section 28 coupled to the first distal section 26 at a proximal end of the first distal section 26, a first stimulation electrode 31 at the first distal section 26 facing away from the first proximal section 28, and a first electrical contact 30 at the first proximal section 28 facing away from the first distal section 26.

[0064] The first stimulation electrode 31 is electrically coupled to the first electrical contact 30. The first stimulation electrode 31 may be electrically coupled to the first electrical contact 30 by a first electrically conductive element (not shown), e.g. a conductive wire, lead, or other appropriate conductor. The first stimulation electrode 31 may be at least partly exposed to surroundings of the implantable medical device 20. The first stimulation electrode 31 may be arranged for electrically stimulating the tissue 50 of the patient. For example, the first stimulation electrode 31 may be used for stimulating the myocardium. A stimulation site, at which the first module 22, in particular the first stimulation electrode 31, is arranged may be the left bundle brunch area in the deep ventricular septum, for example.

[0065] The second module 24 has a second distal section 38, a second proximal section 39, and a second electrical contact 42 at the second distal section 38. The second distal section 38 is coupled to the first proximal section 28 of the first module 22. The second distal section 38 is coupled to the first proximal section 28 in such a way that the first module 22 may be separated from the second module 24 without destroying the implantable medical device 20. In other words, the second distal section 38 is nondestructively decoupleable coupled to the first proximal section 28. The second proximal section 39 may be coupled to an implanting tool 54 for implanting the implantable medical device 20. The second proximal section 39

[0066] 23.184P-WO / 13.11.2025 is coupled to a proximal end of the second distal section 38 facing away from the first module 22.

[0067] The first electrical contact 30 and the second electrical contact 42 are in electrical contact with each other. The first electrical contact 30 and the second electrical contact 42 may physically touch each other when they are in electrical contact with each other, in particular in the first state. The first electrical contact 30 and the second electrical contact 42 may be configured as a unipolar electrical connection or as a bipolar electrical connection. The first electrical contact 30 and the second electrical contact 42 may form a common contact device which is designed to establish permanent electrical contact of the first module 22 with the second module 24 after the implantation of the first module 22 and after coupling the second module 24 to the first module 22.

[0068] The first electrical contact 30 and the second electrical contact 42 are formed and arranged such that they are electrically separated from each other when the first module 22 and the second module 24 are decoupled from each other, as described below with respect to figure 2. The common contact device is designed to be separated without the first module having to be explanted, i.e. without removing it from its myocardial anchorage. The first and second electrical contacts 30, 42 of the common contact device each may be made of the same or an electrochemically comparable combination of materials, so that corrosion is sufficiently excluded even in contact with body fluids.

[0069] The first electrical contact 30 and the second electrical contact 42 are formed such that the first electrical contact 30 is movable relative to the second electrical 42 contact parallel to a distal direction without losing the electrical connection to each other when the first module 22 is moved relative to the second module 24 parallel to the distal direction. To this end, the first electrical contact 30 of the first module 22 may comprise an electrically conductive pin 32 extending from the proximal end of the first distal section 26 in proximal direction and the second distal section 38 of the second module 24 comprises a module recess 40 extending from a distal end of the second distal section 38 in the proximal direction. The second electrical contact 42 of the implantable medical device 20 may be arranged within the

[0070] 23.184P-WO / 13.11.2025 module recess 40. The pin 32 may be at least partly arranged within the module recess 40 such that the pin 32 is electrically coupled to the second electrical contact 42.

[0071] In an alternative embodiment (not shown), the second electrical contact 42 of the second module 24 may comprise the electrically conductive pin 32 extending from a distal end of the second proximal section 39 in distal direction and the first proximal section 28 of the first module 22 may comprise the module recess 40 extending from the proximal end of the first proximal section 28 in the distal direction. Again, the pin 32 may be at least partly arranged within the module recess 40 such that the second electrical contact 42 is electrically coupled to the first electrical contact 30.

[0072] The pin 32 and the module recess 40 may form a plug-in contact. As used in the present description, the proximal direction is a parallel to the distal direction wherein an orientation of the proximal direction is opposed to the distal direction. The common contact device may be designed in such a way that it can compensate for a different implantation depth of the first module 22. This may be realized by the pin 32 being sufficiently long. For example, the pin 32 have a length of 0.1 mm to 10 mm, e.g. of 1 mm to 7 mm, e.g. of 2 mm to 5 mm.

[0073] The second electrical contact 42 may comprise a contact recess 43 in which the pin 32 may be at least partly arranged such that the pin 32 at least partly extends through the contact recess 43. For example, the second electrical contact 42 may be ring-shaped, with the corresponding ring-shape surrounding the contact recess 43. The second electrical contact 42 may comprise an elastic body 45. For example, the second electrical contact 42 may consist of the elastic body 45. That the elastic body 45 is elastic may mean in this context that the elastic body 45 comprises or consists of an elastic material. The elastic material may be rubber or silicon, for example. For example, the second electrical contact 42 may be made of a rubber body in which electrically conductive particles are embedded such that the second electrical contact 42 is electrically conductive. Alternatively or additionally, that the elastic body 45 is elastic may mean in this context that the elastic body 45 has a stiffness from 5 N*mA2 to 120 N*mA2 , e.g. from 20 N*mA2 to 60 N*mA2.

[0074] 23.184P-WO / 13.11.2025 The first module 22 may comprise a first housing 21 and the second module 24 may comprise a second housing 35. The second housing 35 may comprise or may represent a second stimulation electrode 31.

[0075] The first housing 21 and / or the second housing 35 and as such the first and, respectively second module 22, 24 each may have a cylindrical shape. In this case, the implantable medical device 20 may have a cylindrical shape consisting of the cylindrical first module 22 and the cylindrical second module 24. The first module 22, in particular the first housing 21, may be fully or partially flexible and / or may comprise or may consist of a flexible material. The flexible material of the first housing 21 may consist of or may comprise a thermoplastic elastomer like polyurethane or polyether block amide The second module 24, in particular the second housing 35, may comprise or may consist at least in part of a rigid material. The rigid material of the second housing 35 may consist of or may comprise titanium. Alternatively, the second module 24, in particular the second housing 35, may comprise at least in part a flexible material. For example, the second module 24 may be flexible in its middle or distal section. The flexible material of the second module 24 may correspond to the flexible material of the first module 22. The first housing 21 and the second housing 35 may comprise or may be made of a material which does not corrode when having contact to one or more body liquids of the patient.

[0076] The first module 22 may comprise a first anchor element 36 at the first distal section 26, e.g. at a distal end of the first distal section 26. The first anchor element 36 may at least in part be exposed to the surroundings of the implantable medical device 22. The first anchor element 36 may be configured for permanently fixing the first module 22 to the tissue 50 of the patient, e.g. in the myocardium. The first anchor element 36 may be helically shaped and / or may comprise a sharp tip at a distal end of the first anchor element 36, e.g. like a corkscrew. Optionally, the first anchor element 36 may be configured as the first stimulation electrode 29 or comprises the first stimulation electrode 29.

[0077] The second module 24 may comprise a second anchor element 46 at the second distal section 38, e.g. at a distal end of the second distal section 38. The second anchor element 46 may at least in part be exposed to the surroundings of the implantable medical device 20. The second

[0078] 23.184P-WO / 13.11.2025 anchor element 46 may be configured for fixing the second module 24 to the tissue 50 of the patient. The second anchor element 46 may fix the second module 24 to or in the myocardial tissue. The second anchor element 46 may comprise two or more, e.g. four, tines 47, as they are known in the art.

[0079] The implantable medical device 20 may comprise a ring-shaped seal 48 surrounding a seal recess 49. The seal 48 may be arranged in distal direction between the second electrical contact 42 and the first distal section 26 of the first module 22. The seal 48 may be arranged in direction perpendicular to the distal direction between the pin 32 and the module recess 40 such that the pin 32 extends through the seal recess 49 and that the ring-shaped seal 48 is arranged between the pin 32 and an inner wall of the module recess 40. An outer diameter of the ring-shaped seal 48 may be formed with an interference fit to an inner diameter of the module recess 40 and an outer diameter of the pin 32 may be formed with an interference fit to an inner diameter of the seal recess 49.

[0080] The implantable medical device 20 may comprise an energy source 41 for supplying electric energy to the first stimulation electrode 29 via the second electrical contact 42 and the first electrical contact 30. The energy source 41 may be arranged within the second module 24. The energy source 41 may be electrically coupled to the second electrical contact 42.

[0081] The second stimulation electrode 31 may be arranged at the second module 24. The second stimulation electrode 31 may be electrically coupled to the energy source 41. The second stimulation electrode 31 may be at least partly exposed to surroundings of the implantable medical device 20. The second stimulation electrode 31 may be arranged for electrically stimulating the tissue 50 of the patient, e.g. in cooperation with the first stimulation electrode 29. For example, the second stimulation electrode 31 may be a counter electrode, e.g. an anode, for stimulation against the first stimulation electrode 29. The second stimulation electrode 31 may be electrically coupled to the energy source 41 by a second electrically conductive element (not shown), e.g. a wire, lead, or other appropriate conductor. Optionally, in in case of the second module 24 comprising the second anchor element 46, the second anchor element 46 may be configured as the second stimulation electrode 31 or comprises the second stimulation electrode 31.

[0082] 23.184P-WO / 13.11.2025 The implantable medical device 20 may comprise a first part 25 and a second part 27 of a mechanical connection 23 for mechanically connecting the first module 22 to the second module 24. The first part 25 may be arranged at the proximal end of the first proximal section 28 of the first module 22. The second part 27 of the mechanical connection 23 may be arranged at the distal end of the second distal section 38 of the second module 24 and may be mechanically coupled to the first part 25. The first part 25 and the second part 27 of the mechanical connection 23 may be configured such that first module 22 is nondestructive decoupleable from the second module 24 by mechanically decoupling the first part 25 from the second part 27. The first part 25 may comprise an external or internal thread (not shown) and the second part 27 may comprise a corresponding internal or, respectively, external thread such that the first and second modules 22, 24 may be screwed to each other by the corresponding external and internal thread.

[0083] Optionally, the first part 25 may comprise the first electrical contact 30 and the second part 27 may comprise the second electrical contact 42. In this case, the common contact device formed by the first and second electrical contacts 30, 42 may be a screw contact.

[0084] The pin 32 may comprise a first tapered portion 34 at a proximal end of the pin 32. The module recess 40 may comprise a second tapered portion 44 at a distal end of the module recess 40. The tapered portions 34, 44 may contribute to easily and accurately introduce the pin 32 into the module recess 40 and thereby to easily and accurately couple the second module 24 to the first module 22.

[0085] A control unit (not shown) for controlling the implantable medical device 20 may be arranged within the first module 22 or within the second module 25. The control unit may be configured for stimulating the patient’s tissue via the first stimulation electrode 31.

[0086] Fig- 2 shows a perspective, semi-cut view of an exemplary embodiment of an implantable medical device 20, in a second state of the implantable medical device 20. The implantable medical device 20 may be in a second state when the first module 22 is decoupled from the second module 24. The implantable medical device 20 maybe in the second state during the

[0087] 23.184P-WO / 13.11.2025 implementation process. In particular, the first module 22 decoupled from the second module 24 may be implanted first and the second module 24 may be implanted and coupled to the first module 22 afterwards.

[0088] Fig- 3 shows a perspective view of a first step of a method for implanting a first module of the implantable medical device 20 of figures 1 and 2. In the first step, the implantable medical device 20 may be guided to the tissue 50 of the patient by a conventional implanting tool 51. The conventional implanting tool 51 may comprise a lead body 52. The lead body 52 may be configured for accommodating and thereby holding the first proximal section 29 of the first module 22. The lead body 52 may be a removable, flexible extension of the conventional implanting tool 51, e.g. as it is widely used for known catheter techniques.

[0089] Fig- 4 shows a perspective view of a second step of the method for implanting the first module 22 of the implantable medical device 20 of figures 1 and 2. In the second step, the first module 22 may be implanted into the tissue 50 of the patient by the conventional implanting tool 51, e.g. via the lead body 52.

[0090] Fig- 5 shows a perspective view of a third step of the method for implanting the first module 22 of the implantable medical device 20 of figures 1 and 2. In the third step, it may be tested whether the first module 22 is properly arranged at the tissue 50 of the patient and / or whether the first module 22 functions as intended for its use by applying electric energy to the first stimulation electrode 29 of the first module 22 via the conventional implanting tool 51, in particular the lead body 53, and the first electrical contact 30. The electric energy may be applied to the first stimulation electrode 29 by coupling the first stimulation electrode 29 to an electric potential of an external energy source (not shown) via the first electrical contact 30 and an electric line, e.g. a cable 53, of the conventional implanting tool 51, in particular of the lead body 53. The lead body 53 may include a contact device (not shown) for temporary contacting the first module 22, in particular the first electrical contact 30, and thus allows an electrical intraoperative measurement, e.g. of one or more heating signals.

[0091] Fig. 6 shows a perspective view of a fourth step of the method for implanting the first module

[0092] 22 of the implantable medical device 20 of figures 1 and 2. In the fourth step, the

[0093] 23.184P-WO / 13.11.2025 conventional implanting tool 51 may be decoupled from the first module 22 and the first electrical contact 30 when the first module 22 is properly arranged at the tissue 50 of the patient and / or when the first module 22 functions as intended for its use.

[0094] Afterwards, the second module 24 may be mechanically and electrically coupled to the first module 22 by a (new and inventive) implanting tool 54, as explained in the following.

[0095] Fig- 7 shows a semi-transparent perspective view of an exemplary embodiment of an implanting tool 54 in which the second module 24 of the implantable medical device 20 of figures 1 and 2 is arranged. The implanting tool 54 may be used to implant an implant, such as the implantable medical device 20, in particular a multi-part implant, as for example the modular implantable medical device 20 as described above. In particular, the implanting tool 54 may be used to implant the second module 24 of the implantable medical device 20 and in particular to mechanically and electrically couple the second module 24 to the first module 22 which is already implanted.

[0096] The implanting tool 54 may be or may comprise a catheter. The implanting tool 54 may also be used to explant the implant. The implanting tool 54 may also be used to manipulate the implant, e.g. by rotating the implant. The implanting tool 54 may be mechanically coupled to the implant. For example, at least a part of the implant, e.g. the second module 24, may be arranged within the tubular body 56 of the implanting tool 54. In particular, when the first module 22 is already implanted, the second module 24 may be coupled to the first module 22 by the implanting tool 54, wherein the second module 22 may be accommodated within the cavity 58 of the tubular body 56 at the beginning of the coupling process.

[0097] The implanting tool 54 comprises a tubular body 56, a first channel 70, a second channel 72, a third channel 74, a fourth channel 76, a first wire 90, and a second wire 92. The tubular body 56 surrounds a cavity 58 for accommodating the implantable medical device 20, in particular the second module 24. The tubular body 56 has a distal end 60, a proximal end 62 and a lateral surface 64 extending from the distal end 60 to the proximal end 62. A longitudinal axis 66 of the tubular body 56 extends from the distal end 60 to the proximal end 62. The longitudinal axis 66 may be parallel to the distal direction or the proximal

[0098] 23.184P-WO / 13.11.2025 direction. The tubular body 56 may be mechanically coupled to a guide pipe 68 which may be handled by an operating surgeon.

[0099] The first channel 70 has a first end 71 of the first channel 70 coupled to an outside of the lateral surface 64. The first channel 70 extends laterally away from the lateral surface 64 and then back towards the longitudinal axis 66 beyond the distal end 60 of the tubular body 56. The lateral surface 64 comprises a first surface opening 73 through which the first channel 70 opens out into the cavity 58 at the first end 71 of the first channel 70.

[0100] The second channel 72 has a first end (not shown) of the second channel 72 coupled to the outside of the lateral surface 64. The second channel 72 extends laterally away from the lateral surface 64 and then back towards the longitudinal axis 66 beyond the distal end 60 of the tubular body 56. The lateral surface 64 comprises a second surface opening (not shown) through which the second channel 72 opens out into the cavity 58 at the first end of the second channel 72.

[0101] The third channel 74 has a first end (not shown) of the third channel 74 coupled to the outside of the lateral surface 64. The third channel 74 extends laterally away from the lateral surface 64 and then back towards the longitudinal axis 66 beyond the distal end 60 of the tubular body 56. The lateral surface 64 comprises a third surface opening (not shown) through which the third channel 74 opens out into the cavity 58 at the first end (not shown) of the third channel 74.

[0102] The fourth channel 76 has a first end 77 of the fourth channel 76 coupled to the outside of the lateral surface 64. The fourth channel 76 extends laterally away from the lateral surface 64 and then back towards the longitudinal axis 66 beyond the distal end 60 of the tubular body 56. The lateral surface 64 comprises a fourth surface opening (not shown) through which the fourth channel 76 opens out into the cavity 58 at the first end 77 of the fourth channel 76.

[0103] The first to fourth channels 70, 72, 74, 76 are bent back towards the longitudinal axis 66 such that a first channel opening 80 at a second end of the first channel 70, a second channel

[0104] 23.184P-WO / 13.11.2025 opening 82 at a second end of the second channel 72, a third channel opening 84 at a second end of the third channel 74 and a fourth channel opening 86 at a second end of the fourth channel 76 face each other beyond the distal end 60 of the tubular body 56. The first to fourth surface openings 80, 82, 84, 86 and the first to fourth channels 70, 72, 74, 76 are distributed around a circumference of the tubular body 56 such that the first channel 70 is arranged between the second channel 72 and the fourth channel 76 and opposite to the third channel 74.

[0105] The first wire 90 extends through the tubular body 56 from the proximal end 62 of the tubular body 56 through the first surface opening 73, through the first channel 70, out of the first channel opening 80 into the second channel opening 82, through the second channel 72, through the second surface opening and back to the proximal end 62 of the tubular body 56.

[0106] The second wire 92 extends through the tubular body 56 from the proximal end 62 of the tubular body 56 through the third surface opening, through the third channel 74, out of the third channel opening 84 into the fourth channel opening 86, through the fourth channel 76, through the fourth surface opening and back to the proximal end 62 of the tubular body 56.

[0107] Fig- 8 shows a perspective bottom-view of an exemplary embodiment of the tubular body 56 of the implanting tool 54 of figure 7 and of the first module 22 of the implantable medical device 20 in a first state of the implanting tool 54. In the first state of the implanting tool 54, the first wire 90 is relaxed and forms a first loop 94 between the first channel opening 80 and the second channel opening 82. Also in the first state of the reimplanting tool 54, the second wire 92 is relaxed and forms a second loop 96 between the third channel opening 84 and the fourth channel opening 86. The first loop 94 and the second loop 96 overlap each other such that they surround a common space 98 for accommodating at least a part of the implantable medical device 20. The common space 98 has a first size in lateral direction in the first states of the implanting tool 54, in particular of the first and second wires 90, 92. Further in the first state of the implanting tool 54, the tubular body 56 may be arranged above the first module 22 such that at least the proximal section 28 of the first module 22 extends through the first and second loops 94, 96. In this state, the second module 24 may already be arranged within the tubular body 56, e.g. as shown in figure 7.

[0108] 23.184P-WO / 13.11.2025 Fig- 9 shows a perspective bottom-view of the tubular body 56 of the implanting tool 54 of figure 7 and of the first module 22 of the implantable medical device 20 in a second state of the implanting tool 54. In the second state of the implanting tool 54, the first wire 90 and the second wire 92 are in their corresponding second states in which the first wire 90 and the second wire 92 are strained such that the common space 98 has a second size in lateral direction which is smaller than the first size. So, an extension of the common space 98 in a plane in which the first and second loops 94, 96 lie is narrowed when the wires 90, 92 are strained in the second state. When transitioning from the first state to the second state of the wires 90, 92, the wires 90, 92 are strained more and more and the tubular body 56 is centered with respect to the first module 22, in particular with respect to the first proximal section 28, because the first module 22 is fixed in its first position at the within the tissue 50 and because the loops 94, 96 become more and more narrow. In the second state of the implanting tool 54, the tubular body 46 and the first module 22 may be coaxially arranged with respect to the longitudinal axis 66 of the tubular body 56. So, the wires 90, 92 of the implanting tool 54 form a centering device of the implantable medical device 20.

[0109] The wires 90, 92 of the implanting tool 54 enable to center the tubular body 56 with respect to the implant or at least a part of the implant, e.g. the first proximal section 28 and / or the pin 32. When the second module 24 is already arranged in the tubular body 56, the centering device allows the second module 24 to be positioned centrally above the first electrical contact 30 of the first module 22.

[0110] Fig. 10 shows a perspective bottom-view of the tubular body of the implanting tool 54 of figure 7 and of the first module 22 of the implantable medical device 20 in a third state of the implanting tool 54. In the third state of the implanting tool 54, the tubular body 56 is centered with respect to the first module 22, e.g. to the first proximal section 28 and / or the pin 32, and the second anchor element 46 of the second module 24 projects out of the cavity 58 of the tubular body 56 and into the tissue 50. In particular, the tines 47 may be at least partly arranged within the tissue 50. The tines 47 may have a hook-shape in a relaxed state of the tines 47 and the tines 47 may be elastically deformable. In this case, the tines 47 may be stretched such that they are straight when the second module 24 is arranged in the tubular

[0111] 23.184P-WO / 13.11.2025 body 54. Then, when the second module 24 is projected from the cavity 58, as shown in figure 10, the stretched, straight tines 47 may enter the tissue 50. However, because of the elasticity of the tines 47 and because the tubular body 56 not restraining the tines 47 when exiting the cavity 58 furthermore, the tines 47 relax into their hook-shaped when exiting the cavity 58, as shown in figure 11.

[0112] Fig. 11 shows a perspective bottom-view of the tubular body 56 of the implanting tool 54 of figure 7 and of the first module 22 of the implantable medical device 20 in a fourth state of the implanting tool 54. In the fourth state of the implanting tool 54, the first and second modules 22, 24 may be mechanically coupled to each other thereby closing the electrical contacts 30, 42 of the contact device. In addition, the tines 47 have their hook-shape and thereby fix the second module 24 to the tissue 50 via the hook-shaped tines 47. Then, the implanting tool 54 may be removed from the implantable medical device 20.

[0113] Fig. 12 shows a perspective bottom-view of the implantable medical device 20 of figures 1 and 2. For example, figure 12 shows the implantable medical device 20 of figure 11 after removing the implanting tool 54. The implantable medical device 20 may be in the same state as described with respect to figure 1.

[0114] Fig. 13 shows a perspective bottom-view of another exemplary embodiment of the tubular body 56 of the implanting tool 54 of figure 7 and of the first module 22 of the implantable medical device 20 in the first state of the implanting tool 54. The tubular body 56 shown in figure 13 may widely correspond to the tubular body 56 described with respect to figure 8. Therefore, only those features of the tubular body 56 are described in the following, in which the tubular body 56 shown in figure 13 differs from the tubular body 56 shown in figure 8.

[0115] In the embodiment shown in figure 13, the implanting tool 54 comprises a first stop-element 100, a second stop-element 102, a third stop-element 104, and a fourth-stop element 106. The first stop-element 100 and the second stop-element 102 may be fixedly arranged at the first wire 90 between the first channel opening 80 and the second channel opening 82. The first and second stop-elements 100, 102 are formed such that they cannot be pulled into the first and second channel openings 80, 82 thereby defining a minimal size of the first loop

[0116] 23.184P-WO / 13.11.2025 94. The third stop-element 104 and the fourth-stop element 106 are fixedly arranged at the second wire 92 between the third channel opening 84 and the fourth channel opening 86. The third and fourth stop-elements 104, 106 are formed such that they cannot be pulled into the third and fourth channel openings 84, 86 thereby defining a minimal size of the second loop 96.

[0117] The first state of the implanting tool 54 shown in figure 13 may correspond to the first state of the implanting tool 54 shown in figure 8. In particular, the wires 90, 92 are relaxed and form the loops 94, 96 with the common space 98 having the first size in the lateral direction.

[0118] Fig. 14 shows a perspective bottom-view of the tubular body 56 of the implanting tool 54 of figure 13 and of the first module 22 of the implantable medical device 20 in the second state of the implanting tool 54. In the second state of the implanting tool 54, the wires 90, 92 are strained and the common space 98 has a second size in the lateral direction. The stopelements 100, 102, 104, 106 may be arranged at the corresponding wires 90, 92 such that the wires 90, 92 being in the second states and having their minimal sizes may still be able to hold the part of the implantable medical device 20, e.g. the first module 22, in particular the first proximal section 28 and / or the pin 32, by a press fit between each other.

[0119] It will be apparent to those skilled in the art that numerous modifications and variations of the described examples and embodiments are possible in light of the above teaching. The disclosed examples and embodiments are presented for purposes of illustration only. Other alternate embodiments may include some or all of the features disclosed herein. Therefore, it is the intent to cover all such modifications and alternate embodiments as may come within the true scope of this invention.

[0120] Finally, 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.

[0121] The disclosed invention comprises the following numbered embodiments:

[0122] 23.184P-WO / 13.11.2025 1. Implantable medical device (20), comprising: a first module (22) having a first distal section (26) for being implanted into a tissue (50) of a patient, a first proximal section (28) coupled to the first distal section (26) at a proximal end of the first distal section (26), a first stimulation electrode (29) at the first distal section (26) facing away from the first proximal section (28), and a first electrical contact (30) at the first proximal section (28) facing away from the first distal section (26), wherein the first stimulation electrode (29) is electrically coupled to the first electrical contact (30); and a second module (24) having a second distal section (38) nondestructive decoupleable coupled to the first proximal section (28) of the first module (22), a second proximal section (39) being coupled to a proximal end of the second distal section (38) facing away from the first module (22), and a second electrical contact (42) at the second distal section (38), wherein the first electrical contact (30) and the second electrical contact (42) are in electrical contact with each other and wherein the first electrical contact (30) and the second electrical contact (42) are formed and arranged such that they are electrically separated from each other when the first module (22) and the second module (24) are decoupled from each other.

[0123] 2. Implantable medical device (20) according to embodiment 1, wherein the first electrical contact (30) and the second electrical contact (42) are formed such that the first electrical contact (30) is movable relative to the second electrical contact (42) parallel to a distal direction without losing the electrical connection to each other when the first module (22) is moved relative to the second module (24) parallel to the distal direction.

[0124] 3. Implantable medical device (20) according one of the preceding embodiments, wherein the first electrical contact (30) of the first module (22) comprises an electrically conductive pin (32) extending from the proximal end of the first distal section (26) in proximal direction,

[0125] 23.184P-WO / 13.11.2025 the second distal section (38) of the second module (24) comprises a module recess (40) extending from a distal end of the second distal section (38) in the proximal direction, a second electrical contact (42) of the implantable medical device (20) is arranged within the module recess (40), and the pin (32) is at least partly arranged within the module recess (40) such that the pin (32) is electrically coupled to the second electrical contact (42). Implantable medical device (20) according to embodiment 3, wherein the second electrical contact (42) comprises a contact recess (43) in which the pin (32) is at least partly arranged such that the pin (32) at least partly extends through the contact recess (43). Implantable medical device (20) according to embodiment 4, wherein the second electrical contact (42) is ring-shaped, with the corresponding ring-shape surrounding the contact recess (43). Implantable medical device (20) according to one of embodiments 2 to 5, wherein the second electrical contact (42) comprises an elastic body (45). Implantable medical device (20) according to one of embodiments 3 to 6, comprising: a ring-shaped seal (48) surrounding a seal recess (49), being arranged in distal direction between the second electrical contact (42) and the first distal section (26) of the first module (22), and being arranged in direction perpendicular to distal direction between the pin (32) and the module recess (40) such that the pin (32) extends through the seal recess (49) and that the ring-shaped seal (48) is arranged between the pin (32) and an inner wall of the module recess (40), wherein an outer diameter of the ring-shaped seal (48) is formed with an interference fit to an inner diameter of the module recess (40) and an outer diameter of the pin (32) is formed with an interference fit to an inner diameter of the seal recess (49).

[0126] 23.184P-WO / 13.11.2025 Implantable medical device (20) according to one of the preceding embodiments, comprising: an energy source (41) for supplying electric energy to the first stimulation electrode (29) via the second electrical contact (42) and the first electrical contact (30), the energy source (41) being arranged within the second module (24) and being electrically coupled to the second electrical contact (42). Implantable medical device (20) according to embodiment 8, comprising: a second stimulation electrode (31) being arranged at the second module (24) and being electrically coupled to the energy source (41). Implantable medical device (20) according to embodiment 8, wherein the second module (24) comprises a housing (35), and at least a part of the housing (35) is configured as the second stimulation electrode (31). Implantable medical device (20) according to one of the preceding embodiments, comprising: a first part (25) of a mechanical connection (23) for mechanically connecting the first module (22) to the second module (24), the first part (25) being arranged at the proximal end of the first proximal section (28) of the first module (22); and a second part (27) of the mechanical connection (23), the second part (27) being arranged at the distal end of the second distal section (38) of the second module (24) and being mechanically coupled to the first part (25), wherein the first part (25) and the second part (27) of the mechanical connection (23) are configured such that first module (22) is nondestructive decoupleable from the second module (24) by mechanically decoupling the first part (25) from the second part (27). Implantable medical device (20) according to embodiment 11, wherein the first part (25) comprises the first electrical contact (30), and the second part (27) comprises the second electrical contact (42).

[0127] 23.184P-WO / 13.11.2025 Method for implanting an implantable medical device (20) according to one of the preceding embodiments into a body of a patient, the method comprising: implanting the first module (22) into the tissue (50) of the patient by a conventional implanting tool (51); testing whether the first module (22) is properly arranged at the tissue (50) of the patient and / or whether the first module (22) functions as intended for its use by applying electric energy to the first stimulation electrode (29) of the first module (22) via the conventional implanting tool (51) and the first electrical contact (30); decoupling the conventional implanting tool (51) from the first module (22) and the first electrical contact (30) when the first module (22) is properly arranged at the tissue (50) of the patient and / or when the first module (22) functions as intended for its use; and mechanically and electrically coupling the second module (24) to the first module (22). Implanting tool (54) for implanting an implantable medical device (20), the implanting tool (54) comprising: a tubular body (56) surrounding a cavity (58) for accommodating the implantable medical device (20), the tubular body (56) having a distal end (60), a proximal end (62) and a lateral surface (64) extending from the distal end (60) to the proximal end (62), with a longitudinal axis (66) of the tubular body (56) extending from the distal end (60) to the proximal end (62); a first channel (70) having a first end (71) of the first channel (70) coupled to an outside of the lateral surface (64), with the first channel (70) laterally extending away from the lateral surface (64) and then extending back towards the longitudinal axis (66) beyond the distal end (60) of the tubular body (56), wherein the lateral surface (64) comprises a first surface opening (73) through which the first channel (70) opens out into the cavity (58) at the first end (71) of the first channel (70); a second channel (72) having a first end of the second channel (72) coupled to the outside of the lateral surface (64), with the second channel (72) laterally extending away from the lateral surface (64) and then extending back towards the longitudinal axis (66) beyond the distal end (60) of the tubular body (56), wherein the lateral surface

[0128] 23.184P-WO / 13.11.2025 (64) comprises a second surface opening through which the second channel (72) opens out into the cavity (58) at the first end of the second channel (72); a third channel (74) having a first end (77) of the third channel (74) coupled to the outside of the lateral surface (64), with the third channel (74) laterally extending away from the lateral surface (64) and then extending back towards the longitudinal axis (66) beyond the distal end (60) of the tubular body (56), wherein the lateral surface (64) comprises a third surface opening through which the third channel (74) opens out into the cavity (58) at the first end (77) of the third channel (74); a fourth channel (76) having a first end (77) of the fourth channel (76) coupled to the outside of the lateral surface (64), with the fourth channel (76) laterally extending away from the lateral surface (64) and then extending back towards the longitudinal axis (66) beyond the distal end (60) of the tubular body (56), wherein the lateral surface (64) comprises a fourth surface opening through which the fourth channel (76) opens out into the cavity (58) at the first end (77) of the fourth channel (76), wherein the first to fourth channels (70, 72, 74, 76) are bent back towards the longitudinal axis (66) such that a first channel opening (80) at a second end of the first channel (70), a second channel opening (82) at a second end of the second channel (72), a third channel opening (84) at a second end of the third channel (74) and a fourth channel opening (86) at a second end of the fourth channel (76) face each other beyond the distal end (60) of the tubular body (56), and wherein the first to fourth surface openings and the first to fourth channels (70, 72, 74, 76) are distributed around a circumference of the tubular body (56) such that the first channel (70) is arranged between the second channel (72) and the fourth channel (76) and opposite to the third channel (74); a first wire (90) extending through the tubular body (56) from the proximal end (62) of the tubular body (56) through the first surface opening (73), through the first channel (70), out of the first channel opening (80) into the second channel opening (82), through the second channel (72), through the second surface opening and back to the proximal end (62) of the tubular body (56), wherein the first wire (90) is relaxed in a first state of the first wire (90) and forms a first loop (94) between the first channel opening (80) and the second channel opening (82); and a second wire (92) extending through the tubular body (56) from the proximal end (62) of the tubular body (56) through the third surface opening, through the third channel

[0129] 23.184P-WO / 13.11.2025 (74), out of the third channel opening (84) into the fourth channel opening (86), through the fourth channel (76), through the fourth surface opening and back to the proximal end (62) of the tubular body (56), wherein the second wire (92) is relaxed in a first state of the second wire (92) and forms a second loop (96) between the third channel opening (84) and the fourth channel opening (86), wherein the first loop (94) and the second loop (96) overlap each other such that they surround a common space (98) for accommodating at least a part of the implantable medical device (20), wherein the common space (98) has a first size in lateral direction in the first states of the first and second wires (90, 92) and wherein the common space (98) has a second size in lateral direction smaller than the first size when the first wire (90) and the second wire (92) are in corresponding second states in which the first wire (90) and the second wire (92) are strained. Implanting tool (54) according to embodiment 14, comprising: a first stop-element (100) and a second stop-element (102) fixedly arranged at the first wire (90) between the first channel opening (80) and the second channel opening (82), wherein the first and second stop-elements (100, 102) are formed such that they cannot be pulled into the first and second channel openings (80, 82) thereby defining a minimal size of the first loop (94); and a third stop-element (104) and a fourth-stop element (106) fixedly arranged at the second wire (92) between the third channel opening (84) and the fourth channel opening (86), wherein the third and fourth stop-elements (104, 106) are formed such that they cannot be pulled into the third and fourth channel openings (84, 86) thereby defining a minimal size of the second loop (96).

[0130] 23.184P-WO / 13.11.2025 List of Reference Numerals

[0131] 20 implantable medical device

[0132] 21 first housing

[0133] 22 first module

[0134] 23 mechanical connection

[0135] 24 second module

[0136] 25 first part

[0137] 26 first distal section

[0138] 27 second part

[0139] 28 first proximal section

[0140] 29 first stimulation electrode

[0141] 30 first electrical contact

[0142] 31 second stimulation electrode

[0143] 32 pin

[0144] 34 first tapered portion

[0145] 35 second housing

[0146] 36 first anchor element

[0147] 38 second distal section

[0148] 39 second proximal section

[0149] 40 module recess

[0150] 41 energy source

[0151] 42 second electrical contact

[0152] 43 contact recess

[0153] 44 second tapered portion

[0154] 45 elastic body

[0155] 46 second anchor element

[0156] 47 tine

[0157] 48 seal

[0158] 49 seal recess

[0159] 50 tissue

[0160] 51 conventional implanting tool

[0161] 23.184P-WO / 13.11.2025 52 lead body

[0162] 53 cable

[0163] 54 implanting tool

[0164] 56 tubular body

[0165] 58 cavity

[0166] 60 distal end tubular body

[0167] 62 proximal end tubular body

[0168] 64 lateral surface

[0169] 66 longitudinal axis

[0170] 68 guide pipe

[0171] 70 first channel

[0172] 71 first end first channel

[0173] 72 second channel

[0174] 73 first surface opening

[0175] 74 third channel

[0176] 76 fourth channel

[0177] 77 first end fourth channel

[0178] 80 first channel opening

[0179] 82 second channel opening

[0180] 84 third channel opening

[0181] 86 fourth channel opening

[0182] 90 first wire

[0183] 92 second wire

[0184] 94 first loop

[0185] 96 second loop

[0186] 98 common space

[0187] 100 first stop element

[0188] 102 second stop element

[0189] 104 third stop element

[0190] 106 fourth stop element

[0191] 23.184P-WO / 13.11.2025

Claims

Claims1. Implanting tool (54) for implanting an implantable medical device (20), the implanting tool (54) comprising: a tubular body (56) surrounding a cavity (58) for accommodating the implantable medical device (20), the tubular body (56) having a distal end (60), a proximal end (62) and a lateral surface (64) extending from the distal end (60) to the proximal end (62), with a longitudinal axis (66) of the tubular body (56) extending from the distal end (60) to the proximal end (62); a first channel (70) having a first end (71) of the first channel (70) coupled to an outside of the lateral surface (64), with the first channel (70) laterally extending away from the lateral surface (64) and then extending back towards the longitudinal axis (66) beyond the distal end (60) of the tubular body (56), wherein the lateral surface (64) comprises a first surface opening (73) through which the first channel (70) opens out into the cavity (58) at the first end (71) of the first channel (70); a second channel (72) having a first end of the second channel (72) coupled to the outside of the lateral surface (64), with the second channel (72) laterally extending away from the lateral surface (64) and then extending back towards the longitudinal axis (66) beyond the distal end (60) of the tubular body (56), wherein the lateral surface (64) comprises a second surface opening through which the second channel (72) opens out into the cavity (58) at the first end of the second channel (72); a third channel (74) having a first end (77) of the third channel (74) coupled to the outside of the lateral surface (64), with the third channel (74) laterally extending away from the lateral surface (64) and then extending back towards the longitudinal axis (66) beyond the distal end (60) of the tubular body (56), wherein the lateral surface (64) comprises a third surface opening through which the third channel (74) opens out into the cavity (58) at the first end (77) of the third channel (74); a fourth channel (76) having a first end (77) of the fourth channel (76) coupled to the outside of the lateral surface (64), with the fourth channel (76) laterally extending away from the lateral surface (64) and then extending back towards the longitudinal axis (66) beyond the distal end (60) of the tubular body (56), wherein the lateral surface (64) comprises a fourth surface opening through which the fourth channel (76) opens23.184P-WO / 13.11.2025out into the cavity (58) at the first end (77) of the fourth channel (76), wherein the first to fourth channels (70, 72, 74, 76) are bent back towards the longitudinal axis (66) such that a first channel opening (80) at a second end of the first channel (70), a second channel opening (82) at a second end of the second channel (72), a third channel opening (84) at a second end of the third channel (74) and a fourth channel opening (86) at a second end of the fourth channel (76) face each other beyond the distal end (60) of the tubular body (56), and wherein the first to fourth surface openings and the first to fourth channels (70, 72, 74, 76) are distributed around a circumference of the tubular body (56) such that the first channel (70) is arranged between the second channel (72) and the fourth channel (76) and opposite to the third channel (74); a first wire (90) extending through the tubular body (56) from the proximal end (62) of the tubular body (56) through the first surface opening (73), through the first channel (70), out of the first channel opening (80) into the second channel opening (82), through the second channel (72), through the second surface opening and back to the proximal end (62) of the tubular body (56), wherein the first wire (90) is relaxed in a first state of the first wire (90) and forms a first loop (94) between the first channel opening (80) and the second channel opening (82); and a second wire (92) extending through the tubular body (56) from the proximal end (62) of the tubular body (56) through the third surface opening, through the third channel (74), out of the third channel opening (84) into the fourth channel opening (86), through the fourth channel (76), through the fourth surface opening and back to the proximal end (62) of the tubular body (56), wherein the second wire (92) is relaxed in a first state of the second wire (92) and forms a second loop (96) between the third channel opening (84) and the fourth channel opening (86), wherein the first loop (94) and the second loop (96) overlap each other such that they surround a common space (98) for accommodating at least a part of the implantable medical device (20), wherein the common space (98) has a first size in lateral direction in the first states of the first and second wires (90, 92) and wherein the common space (98) has a second size in lateral direction smaller than the first size when the first wire (90) and the second wire (92) are in corresponding second states in which the first wire (90) and the second wire (92) are strained.23.184P-WO / 13.11.20252. Implanting tool (54) according to claim 1, comprising: a first stop-element (100) and a second stop-element (102) fixedly arranged at the first wire (90) between the first channel opening (80) and the second channel opening (82), wherein the first and second stop-elements (100, 102) are formed such that they cannot be pulled into the first and second channel openings (80, 82) thereby defining a minimal size of the first loop (94); and a third stop-element (104) and a fourth-stop element (106) fixedly arranged at the second wire (92) between the third channel opening (84) and the fourth channel opening (86), wherein the third and fourth stop-elements (104, 106) are formed such that they cannot be pulled into the third and fourth channel openings (84, 86) thereby defining a minimal size of the second loop (96)3. System comprising the implanting tool according to claim 1 or 2 and a second module of an implantable medical device (20).

4. System according to claim 3, wherein the second module (24) having a second distal section (38) nondestructive coupleable to a first proximal section (28) of a first module (22) of an implantable device, a second proximal section (39) being coupled to a proximal end of the second distal section (38) facing away from the first module (22), and a second electrical contact (42) at the second distal section (38), wherein the first electrical contact (30) and the second electrical contact (42) are in electrical contact with each other and wherein the first electrical contact (30) and the second electrical contact (42) are formed and arranged such that they are electrically separated from each other when the first module (22) and the second module (24) are decoupled from each other.

5. System according to claim 4 further comprising a first module of an implantable device, whereby the first module (22) having a first distal section (26) for being implanted into a tissue (50) of a patient, a first proximal section (28) coupled to the first distal section (26) at a proximal end of the first distal section (26), a first stimulation electrode (29) at the first distal section (26) facing away from the first proximal section (28), and a first electrical contact (30) at the first proximal section23.184P-WO / 13.11.2025(28) facing away from the first distal section (26), wherein the first stimulation electrode (29) is electrically coupled to the first electrical contact (30); and the second module (24) having a second distal section (38) nondestructive decoupleable coupled to the first proximal section (28) of the first module (22), a second proximal section (39) being coupled to a proximal end of the second distal section (38) facing away from the first module (22), and a second electrical contact (42) at the second distal section (38), wherein the first electrical contact (30) and the second electrical contact (42) are in electrical contact with each other and wherein the first electrical contact (30) and the second electrical contact (42) are formed and arranged such that they are electrically separated from each other when the first module (22) and the second module (24) are decoupled from each other.

6. System according to claim 5, wherein the first electrical contact (30) and the second electrical contact (42) are formed such that the first electrical contact (30) is movable relative to the second electrical contact (42) parallel to a distal direction without losing the electrical connection to each other when the first module (22) is moved relative to the second module (24) parallel to the distal direction.

7. System (20) according claim 5 or 6, wherein the first electrical contact (30) of the first module (22) comprises an electrically conductive pin (32) extending from the proximal end of the first distal section (26) in proximal direction, the second distal section (38) of the second module (24) comprises a module recess (40) extending from a distal end of the second distal section (38) in the proximal direction, a second electrical contact (42) of the implantable medical device (20) is arranged within the module recess (40), and the pin (32) is at least partly arranged within the module recess (40) such that the pin (32) is electrically coupled to the second electrical contact (42).23.184P-WO / 13.11.20258. System according to claim 7, wherein the second electrical contact (42) comprises a contact recess (43) in which the pin (32) is at least partly arranged such that the pin (32) at least partly extends through the contact recess (43).

9. System according to claim 8, wherein the second electrical contact (42) is ring-shaped, with the corresponding ring-shape surrounding the contact recess (43).

10. System according to one of claims 6 to 9, wherein the second electrical contact (42) comprises an elastic body (45).

11. System according to one of claims 7 to 10, comprising: a ring-shaped seal (48) surrounding a seal recess (49), being arranged in distal direction between the second electrical contact (42) and the first distal section (26) of the first module (22), and being arranged in direction perpendicular to distal direction between the pin (32) and the module recess (40) such that the pin (32) extends through the seal recess (49) and that the ring-shaped seal (48) is arranged between the pin (32) and an inner wall of the module recess (40), wherein an outer diameter of the ring-shaped seal (48) is formed with an interference fit to an inner diameter of the module recess (40) and an outer diameter of the pin (32) is formed with an interference fit to an inner diameter of the seal recess (49).

12. System according to one of the claims 5 to 11, comprising: an energy source (41) for supplying electric energy to the first stimulation electrode (29) via the second electrical contact (42) and the first electrical contact (30), the energy source (41) being arranged within the second module (24) and being electrically coupled to the second electrical contact (42).

13. System according to claim 12, comprising: a second stimulation electrode (31) being arranged at the second module (24) and being electrically coupled to the energy source (41).23.184P-WO / 13.11.202514. System according to claim 12, wherein the second module (24) comprises a housing (35), and at least a part of the housing (35) is configured as the second stimulation electrode (31).

15. System according to one of the claims 5 to 14, comprising: a first part (25) of a mechanical connection (23) for mechanically connecting the first module (22) to the second module (24), the first part (25) being arranged at the proximal end of the first proximal section (28) of the first module (22); and a second part (27) of the mechanical connection (23), the second part (27) being arranged at the distal end of the second distal section (38) of the second module (24) and being mechanically coupled to the first part (25), wherein the first part (25) and the second part (27) of the mechanical connection (23) are configured such that first module (22) is nondestructive decoupleable from the second module (24) by mechanically decoupling the first part (25) from the second part (27).

16. System according to claim 15, wherein the first part (25) comprises the first electrical contact (30), and the second part (27) comprises the second electrical contact (42).23.184P-WO / 13.11.2025

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