System for providing for a cardiac resynchronization therapy

Abstract

A system for providing for a cardiac resynchronization therapy comprises an implantable medical device (1) comprising a generator device (10) having a processing circuitry (100) for controlling operation of the generator device (10). The implantable medical device (1) is configured to be selectively connected to a left-ventricular coronary sinus electrode lead (12) configured for implantation on the left ventricle (LV) through the coronary sinus (CS) or to a left bundle branch electrode lead (13) configured for implantation on the cardiac septum (M) to engage with the conductive structure of the left bundle branch (LBB). A configuration unit (2, 4) has a user interface (20) to modify a configuration of the implantable medical device (1). The user interface (20) is user-actuatable to select a first mode or a second mode out of at least two modes for configuring the implantable medical device (1), wherein in the first mode a first set of parameters is pre-selected or user-selectable for configuring the implantable medical device (1) to function with the left-ventricular coronary sinus electrode lead (12) and in the second mode a second set of parameters is pre-selected or user-selectable for configuring the implantable medical device (1) to function with the left bundle branch electrode lead (13).

Description

[0001] Applicant: BIOTRONIK SE & Co. KG

[0002] Date: 18.10.2024

[0003] Our Reference: 22.255P-WO

[0004] System for providing for a cardiac resynchronization therapy

[0005] The present invention relates to a system for providing for a cardiac resynchronization therapy according to the preamble of claim 1 and to a method for operating a system for providing for a cardiac resynchronization therapy.

[0006] A system of this kind comprises an implantable medical device comprising a generator device having a processing circuitry for controlling operation of the generator device. The implantable medical device is configured to be selectively connected to a left-ventricular coronary sinus electrode lead configured for implantation on the left ventricle through the coronary sinus or to a left bundle branch electrode lead configured for implantation on the cardiac septum to engage with the conductive structure of the left bundle branch.

[0007] With common electrode arrangements of leads of implantable medical stimulation devices, an injection of stimulation signals generally is possible on cardiac tissue, an electrode being in contact with intra-cardiac tissue in order to allow an injection of stimulation energy into the tissue. With new approaches for example for providing a stimulation in case of a so- called left bundle block, it may be desired to provide for an excitation in a localized fashion in the region of the so-called left bundle branch, also denoted as left bundle branch area pacing (LBBAP), which requires to engage with intra-cardiac tissue in the range of the septum of the heart and to place an electrode in the vicinity of the left bundle branch, such that stimulation energy may be specifically injected into the conductive structure of the left bundle branch.

[0008] To be able to perform a left bundle branch area pacing and to in this way provide for a left- ventricular stimulation in case of a so-called left bundle block, an electrode pole arranged on a left bundle branch electrode lead shall engage with intra-cardiac tissue in the range of the septum of the heart in the vicinity of the left bundle branch. Upon implantation of the left bundle branch electrode lead, a stimulation signal is generated at an energy that allows for a reliable stimulation by coupling to the conductive structure of the left bundle branch and by hence stimulating the left ventricle.

[0009] Within a system for providing for a cardiac resynchronization therapy, an implantable medical device may be selectively connected to a left-ventricular coronary sinus electrode lead or to a left bundle branch electrode lead. The left-ventricular coronary sinus electrode lead herein is configured for implantation on the left ventricle through the coronary sinus in order to provide for a stimulation on the left ventricle. The left bundle branch electrode lead, in comparison, is configured for implantation on the cardiac septum to engage with the conductive structure of the left bundle branch. In order to operate the implantable medical device, it is required to adapt parameters, relating for example to functional routines to provide for a cardiac resynchronization therapy making use of the one electrode lead or the other. As certain parameters require a specific adaption according to the setup of electrode leads used on the implantable medical device, currently an in-depth knowledge of suitable parameter values, parameter combinations and functional routines is required, making the configuration of the implantable medical device possibly cumbersome and error-prone.

[0010] It is an object of the instant invention to provide a system for providing for a cardiac resynchronization therapy and a method for operating such a system which in an easy way allow for an adaption of a configuration of the implantable medical device based on a setup of electrode leads used on the implantable medical device.

[0011] This object is achieved by means of a system comprising the features of claim 1.

[0012] Accordingly, the user interface is user-actuatable to select a first mode or a second mode of at least two modes for configuring the implantable medical device, wherein in the first mode a first set of parameters is pre-selected or user-selectable for configuring the implantable medical device to function with the left-ventricular coronary sinus electrode lead and in the second mode a second set of parameters is pre-selected or user-selectable for configuring the implantable medical device to function with the left bundle branch electrode lead. The implantable medical device, prior to implantation, may be selectively connected to the left-ventricular coronary sinus electrode lead or to the left bundle branch electrode lead. Depending on which electrode lead is used, the implantable medical device in an implanted state operates with the left-ventricular coronary sinus electrode lead implanted through the coronary sinus or with the left bundle branch electrode lead implanted in the right ventricle to engage with the conductive structure of the left bundle branch within the septum in between the right ventricle and the left ventricle. Using the one electrode lead or the other, during operation a stimulation of the left ventricle may be effected in order to provide for a cardiac resynchronization therapy to synchronize ventricular activity of the heart.

[0013] Prior to implantation or at an initial start-up upon implantation of the implantable medical device, generally the implantable medical device is programmed using a configuration unit external to the implantable medical device and external to the patient in order to adapt a configuration of the implantable medical device for operation. The configuration unit may for example be a programming device which, during implantation or upon implantation of the implantable medical device in a patient, is operated in proximity to the implantable medical device in order to program the implantable medical device for operation.

[0014] In one embodiment, the configuration unit is a remote device to be operated remotely from the patient. The remote device may be in communication connection with the implantable medical device using a public communication network such as the Internet. For example, the remote device may be a home monitoring service center accessible to a physician, wherein a communication link to the implantable medical device may for example be established via a patient device placed in proximity to the patient and establishing a connection to the implantable medical device implanted in the patient.

[0015] The configuration unit comprises a user interface which allows a user to enter user commands to modify a configuration of the implantable medical device. The user interface may for example comprise a display and an input device. For example, the user interface may be a touch-sensitive display for displaying information as well as for allowing a user to enter user commands. The user interface is user-actuatable to select a first mode a second mode out of at least two modes for configuring the implantable medical device. Using the user interface, hence, a user may select a specific mode according to which the implantable medical device is programmed. Using the user interface, the user hence may specify which mode the implantable medical device shall operate in, wherein dependent on the selected mode different sets of parameters are pre-selected or are user-selectable for configuring the implantable medical device.

[0016] In particular, the first mode is associated with a first set of parameters for configuring the implantable medical device to function with the left-ventricular coronary sinus electrode lead. In turn, the second mode is associated with a second set of parameters for configuring the implantable medical device to function with the left bundle branch electrode lead. According to the selection of the mode by the user, the first set of parameters or the second set of parameters is used to program the implantable medical device for operation, such that by selection of the mode the implantable medical device is setup for operation.

[0017] In that, by selecting the mode, a specific set of parameters is pre-selected or user-selectable, the adaption of the configuration of the implantable medical device is eased for the user. In particular, a user not necessarily needs to have a specific in-depth knowledge about which parameters are suitable and usable within a specific setup of the implantable medical device in connection with a specific electrode lead. Rather, each mode, corresponding to a specific setup of the implantable medical device in connection with one or multiple electrode leads, is associated with a specific set of parameters, wherein within the set of parameters certain values are pre-selected or are user-selectable, but other parameters may automatically be disabled, such that the adaption of parameters, where applicable, takes place automatically according to the mode selection or a user is presented only with those parameters for useradaption which are applicable in the specific mode.

[0018] In one embodiment, the user interface is user-actuatable to adapt, in case of a selection of the first mode using the user interface, at least one parameter of the first set of parameters and, in case of a selection of the second mode using the user interface, at least one parameter of the second set of parameters. Some parameters may be automatically set in dependence on the selected mode. Other parameters, however, may be user-adaptable, for example by presenting those parameters to the user which shall be adapted according to the mode selection, for example by in addition presenting an allowable range for a specific parameter to the user according to the mode selection. The user hence first selects the mode which the implantable medical device shall be operated in, the mode being associated with the specific setup of the implantable medical device, namely the connection of the implantable medical device to the left-ventricular coronary sinus electrode lead or to the left bundle branch electrode lead. Dependent on the mode selection, the user may then set certain parameters which are associated with the specific mode.

[0019] In one embodiment, the first set of parameters and the second set of parameters each define at least one of a value for at least one functional parameter, an allowable range for at least one functional parameter and an activation or deactivation of at least one functional routine. According to the selected mode, certain parameters may automatically be set to specific values suitable for the selected mode, wherein a value of a parameter may be presented to the user and possibly is user-adaptable. For other parameters, an allowable range may be specified and presented to the user according to the mode selection, such that the user is enabled to set the parameter within the allowed range. Yet other parameters may relate to the activation or deactivation of one or multiple functional routines, such that dependent on the selected mode specific functional routines may be automatically activated or deactivated.

[0020] In one embodiment, the first set of parameters and the second set of parameters each define at least one of an electrode lead to be used for outputting a stimulation signal, an electrode lead to be used for an electrocardiogram signal sensing and an electrode lead to be used for an impedance measurement. For example, each mode may be associated with a specific setup of electrode leads. Within the set of parameters associated with a selected mode, it may be defined which electrode lead is used for stimulation, for signal sensing and for an impedance measurement.

[0021] For example, when using the left-ventricular coronary sinus electrode lead on the implantable medical device, in addition a right-ventricular electrode lead and a right-atrial electrode lead may be used. Herein it may be defined that a left-ventricular stimulation signal is output using the left-ventricular coronary sinus electrode lead, whereas an electrocardiogram signal sensing may be defined to take place using the left-ventricular coronary sinus electrode lead and / or the right-ventricular electrode lead. An impedance measurement may be defined to take place using the right-ventricular electrode lead for the purpose of providing for a rate-adaptive cardiac stimulation (also denoted as CLS algorithm).

[0022] In another example, it may be defined that, when using the left bundle branch electrode lead, in addition a right-ventricular electrode lead and a right-atrial electrode lead may be used. In that case it may be defined that a ventricular stimulation is output only using the left bundle branch electrode lead, whereas an electrocardiogram signal sensing for example for a tachycardia sensing takes place using the right-ventricular electrode lead. An impedance measurement for a rate-adaptive cardiac stimulation may for example be defined to take place using the right-ventricular electrode lead.

[0023] In yet another example, when using the left bundle branch electrode lead without an additional right-ventricular electrode lead, but for example only in combination with a right- atrial electrode lead, it may be defined that a ventricular signal sensing as well as an impedance measurement and an output of stimulation signals takes place using the left bundle branch electrode lead.

[0024] In one embodiment, the first set of parameters and the second set of parameters each define an activation or deactivation of at least one of a ventricular stimulation suppression function, a biventricular stimulation function, a left-ventricular T wave protection function and a CRT optimization function.

[0025] The ventricular stimulation suppression function serves to give precedence for a ventricular intrinsic activity if intrinsic conduction is present. For example, within such routine it may be checked whether within a predefined number of cardiac cycles an intrinsic ventricular activity is detected. If an intrinsic cardiac activity is not detected in a predefined number of cycles, a ventricular pacing may be activated, wherein a cardiac pacing however is suppressed if an intrinsic ventricular activity is detected within the predefined number of cardiac cycles. Such ventricular stimulation suppression function may be activated or deactivated according to the selected mode. The biventricular stimulation function serves to provide for a biventricular stimulation both in the right ventricle and the left ventricle. If the biventricular stimulation function is activated, accordingly, a biventricular stimulation in both the right ventricle and the left ventricle is provided, wherein for example an intra-ventricular conduction time (so-called VV time) may be automatically set or may be user-adaptable to provide for the sequence of and delay in between a right-ventricular stimulation and a left-ventricular stimulation.

[0026] The left-ventricular T wave protection function shall prevent a stimulation in the left ventricle in the so-called vulnerable phase of the left ventricle in the initial phase of the T wave. Within the left-ventricular T wave protection function a protection interval corresponding to the vulnerable phase of the left ventricle is set, and within the protection interval a stimulation of the left ventricle is prohibited. According to the setting of the corresponding parameter dependent on the selected mode, the left-ventricular T wave protection function may be activated or deactivated.

[0027] In particular, in one embodiment, the second set of parameters of the second mode defines a deactivation of at least one of the ventricular stimulation suppression function, the biventricular stimulation function, and the left-ventricular T wave protection function.

[0028] In one embodiment, the second set of parameters of the second mode defines a deactivation of (all of) the ventricular stimulation suppression function, the biventricular stimulation function and the left-ventricular T wave protection function.

[0029] In one embodiment, the second set of parameters of the second mode defines an activation of the CRT optimization function.

[0030] Within such a CRT optimization function a timing for a stimulation for a cardiac resynchronization therapy (CRT) is optimized. For this, for example, in a first step, an intrinsic atrial contraction of the heart is detected. Alternatively, the right atrium is stimulated to induce an atrial contraction. In a further step, an intrinsic right-ventricular contraction is detected. Subsequently, an intrinsic atrioventricular conduction time is determined. The atrioventricular conduction time is calculated between the intrinsic atrial contraction and the intrinsic right-ventricular contraction or between the stimulation of the right atrium and the intrinsic right-ventricular contraction (being responsive to the stimulation of the right atrium). In doing so, a factual measure reflecting the condition of the physiologic cardiac conduction system is obtained. In a further step, a stimulated atrioventricular conduction time may be determined from the intrinsic atrioventricular conduction time and may be set for subsequent ventricular simulations performed by the implantable medical device. This stimulated atrioventricular conduction time serves for triggering stimulation of the left ventricle.

[0031] In this context, the stimulated atrioventricular conduction time generally is shorter than the intrinsic atrioventricular conduction time. By applying a stimulated atrioventricular conduction time that is shorter than the intrinsic atrioventricular conduction time, it is guaranteed that a ventricular stimulation, in particular a left-ventricular stimulation, safely occurs prior to any intrinsic excitation that might still be possible even in case of a left bundle branch block. Thus, a shortening of the stimulated atrioventricular conduction time with respect to the intrinsic atrioventricular conduction time ensures a safe ventricular stimulation by the implantable medical device that affects both the right ventricle and the left ventricle of the heart to be stimulated. Consequently, an efficient cardiac resynchronization is achieved.

[0032] In case of any physiologic changes over time, the implantable medical device may adapt the stimulated atrioventricular conduction time to the determined and amended intrinsic atrioventricular conduction time so that the stimulation provided by the implantable medical device keeps track of the condition of the heart to be stimulated and reflects a highly physiologic stimulation.

[0033] Such CRT optimization function may be adapted based on the selected mode in order to provide for an optimization of the CRT timing for the specific, selected mode.

[0034] In one embodiment, the first set of parameters defines a first capture test configuration for defining a capture threshold using a sensing of a non-specific capture. In comparison, the second set of parameters defines a second capture test configuration for defining a capture threshold using a sensing of a specific capture of a left bundle branch area pacing.

[0035] Within a capture test, generally, a capture threshold shall be identified, such that an energy of a stimulation pulse may be set to reliably result in a stimulation. During a capture test, stimulation pulses may repeatedly be output, wherein a stimulation energy of the stimulation pulses is progressively reduced until no longer a capture is identified. The pulse energy of the stimulation pulse at which no longer a capture is observed is assumed to represent the capture threshold, such that a stimulation energy for a stimulation pulse during subsequent operation may be set according to the threshold.

[0036] Herein, when using the implantable medical device together with the left-ventricular coronary sinus electrode lead, within the capture test it may be detected whether a nonspecific capture is observed. The term “non-specific capture” herein shall indicate that the output of a stimulation pulse results in just any ventricular activity. In turn, when using the implantable medical device together with the left bundle branch electrode lead, within the capture test it may be detected whether a specific capture is observed. The term “specific capture” herein shall indicate that the output of a stimulation pulse results in a stimulation of a specific region, namely of the left ventricle by a left bundle branch area pacing (LBBAP), hence indicating a capture to the left bundle branch when using the left bundle branch electrode lead engaged with the left bundle branch structure.

[0037] The assessment for a specific capture may for example be carried out by assessing electrocardiogram signals as detected by a multiplicity of sensing vectors spanned in between different pairs of electrode poles, in order to differentiate between different regions of ventricular activity. In another example, the assessment for a specific capture may be carried out by measuring an impedance in order to assess an impedance curve for the presence of activity in a certain region. This assumes that an impedance curve as recorded during a cardiac cycle substantially is dependent on whether a left-ventricular activity alone, a right-ventricular activity alone or both a left-ventricular activity and a right-ventricular activity occurs, such that by comparing the momentary impedance curve to a reference curve it may be identified whether in particular a left-ventricular activity as stimulated by a left bundle branch area pacing is present.

[0038] In one embodiment, dependent on the selected mode information with respect to the selected mode may be displayed on the user interface, in particular on a display of the user interface. The electrode leads as used on the implantable medical device may be identified on the display of the user interface, such that the user is presented with information about the specific configuration of the implantable medical device associated with the selected mode.

[0039] In one embodiment, dependent on the selected mode, the number and association of stimulation and sensing vectors is adapted.

[0040] In one embodiment, according to the selected mode, an option for a multi-pole stimulation using a multiplicity of electrode poles on one or multiple electrode leads may be activated or deactivated.

[0041] In one embodiment, by assessing signal conditions on the left-ventricular coronary sinus electrode lead respectively the left bundle branch electrode lead and potentially further electrode leads, a electrode lead configuration may be automatically identified by the processing circuitry of the implantable medical device, such that a user for example may be informed that a particular mode is not selectable dependent on an identification of electrode leads connected t the generator device of the implantable medical device.

[0042] In one embodiment, dependent on the selected mode, specific statistics and the diagnostic information may be recorded.

[0043] In one embodiment, dependent on the selected mode, the type of stimulation, for example for providing for a resynchronization therapy or for an anti-bradycardia stimulation, may be defined or may be user-selectable. Dependent on the selected mode, a triggering of a stimulation may be defined, for example a triggering based on a ventricular event or an extrasystole for a resynchronization therapy, wherein such triggering may be deactivated for an anti-bradycardia stimulation. In one embodiment, the implantable medical device is configured to be selectively connected to a right-ventricular electrode lead configured for implantation in the right ventricle. Such right-ventricular electrode lead, for example configured for implantation to engage with tissue at the apex of the right ventricle, may be used in combination with the left-ventricular coronary sinus electrode lead or in combination with the left bundle branch electrode lead.

[0044] In one embodiment, the second set of parameters of the second mode is pre-selected or user- selectable for configuring the implantable medical device to function with the left bundle branch electrode in combination with the right-ventricular lead. In the second mode, it for example may be user-selectable or may be automatically set (for example according to an automatic detection of the presence of the right-ventricular electrode lead) that the left bundle branch electrode lead is combined with the right-ventricular electrode lead.

[0045] In one embodiment, the second set of parameters of the second mode is pre-selected or user- selectable for configuring the implantable medical device to function with the left bundle branch electrode lead not in combination with the right-ventricular electrode lead. Hence, in the second mode it may be pre-selected or user-selectable that the implantable medical device is operated with the left bundle branch electrode lead, but not in combination with a right-ventricular electrode lead. The second mode hence may define an operation of the implantable medical device with the left bundle branch electrode lead without a right- ventricular electrode lead.

[0046] In one embodiment, the first set of parameters and the second set of parameters each define an activation or deactivation of a backup stimulation function using the right-ventricular electrode lead. In particular, within the first set of parameters and the second set of parameters it may be predefined or it may be user-definable whether to use a right-ventricular electrode lead to provide for a backup stimulation. By means of such backup stimulation, a backup stimulation pulse may be provided in case it is observed that no activity is stimulated following a stimulation pulse as output by the left-ventricular coronary sinus electrode lead respectively the left bundle branch electrode lead. It may be user definable in any of the modes whether to employ such backup stimulation or not. In another aspect, a method for operating a system for providing for a cardiac resynchronization therapy comprises: providing an implantable medical device comprising a generator device having a processing circuitry for controlling operation of the generator device; selectively connecting the implantable medical device to a left-ventricular coronary sinus electrode lead configured for implantation through the coronary sinus or to a left bundle branch electrode lead configured for implantation on the cardiac septum to engage with the conductive structure of the left bundle branch; modifying a configuration of the implantable medical device using a configuration unit having a user interface; and selecting a first mode or a second mode out of at least two modes for configuring the implantable medical device by user-actuation of the user interface, wherein in the first mode a first set of parameters is pre-selected or user-selectable for configuring the implantable medical device to function with the left-ventricular coronary sinus electrode lead and in the second mode a second set of parameters is pre-selected or user-selectable for configuring the implantable medical device to function with the left bundle branch electrode lead.

[0047] The advantages and advantageous embodiments described above equally apply also to the method, such that it shall be referred to the above in this respect.

[0048] The idea of the invention shall subsequently be described in more detail with respect to the embodiments shown in the figures. Herein:

[0049] Fig. 1 shows a schematic drawing of a system comprising an implantable medical device, in a setup using a left-ventricular coronary sinus electrode lead;

[0050] Fig. 2 shows a schematic drawing of an implantable medical device in a setup using a left bundle branch electrode lead to provide for a left bundle branch area pacing;

[0051] Fig. 3 shows a schematic drawing of an implantable device in another setup using a left bundle branch electrode lead; Fig. 4 shows a schematic drawing of a display view of a user interface of a configuration unit for configuring the implantable medical device;

[0052] Fig. 5 shows a schematic drawing of another display view of a user interface of a configuration unit for configuring the implantable medical device; and

[0053] Fig.6 shows a schematic drawing of yet another display view of a user interface of a configuration unit for configuring the implantable medical device.

[0054] Subsequently, embodiments of the invention shall be described in detail with reference to the drawings. In the drawings, like reference numerals designate like structural elements.

[0055] It is to be noted that the embodiments are not limiting for the invention, but merely represent illustrative examples.

[0056] Fig. 1 shows, in a schematic drawing, the human heart H comprising the right atrium RA, the right ventricle RV, the left atrium LA and the left ventricle LV. An implantable medical device 1 is implanted in a patient, the implantable medical device 1 comprising a generator device 14 connected to leads 10, 11, 12 extending from the generator device 14 through the superior vena V into the patient's heart H. By means of the leads 10, 11, 12, electrical signals for providing a pacing action in the heart H shall be injected into intra-cardiac tissue potentially at different locations within the heart, and sense signals may be received.

[0057] In the embodiment of Fig. 1, an electrode lead 10 is implanted into the heart H such that it extends into the right ventricle RV of the heart H and, at a distal end 101 of a lead body 100, is arranged on intra-cardiac tissue in the region of the apex of the right ventricle RV. An electrode lead 11 in turn is implanted such that it reaches into the right atrium RA and with a distal end 111 of a lead body 110 is placed on tissue in the right atrium RA. An electrode lead 12, denoted herein as left-ventricular coronary sinus electrode lead, is implanted through the coronary sinus CS on the left ventricle LV and with a distal end 121 of a lead body 120 is in contact with tissue on the outside of the left ventricle LV. An implantable medical device 1 as concerned herein may generally be a cardiac stimulation device such as a cardiac pacemaker device. A stimulation device of this kind comprises a generator 14, as shown in Fig. 1, which may be subcutaneously implanted in a patient at a location remote from the heart H, one or multiple leads 10, 11, 12 extending from the generator device 14 into the heart H for emitting stimulation signals in the heart H and for obtaining sense signals at one or multiple locations from the heart H. The leads 10, 11, 12 each form a generally longitudinal, tubular body, which reaches into the heart H and is anchored at a location of interest in or on the heart H.

[0058] The implantable medical device 1 as described herein in particular shall serve to provide a stimulation for a cardiac resynchronization therapy.

[0059] In the setup of Fig. 1, stimulation signals may be output using electrode poles of the electrode leads 10, 11, 12 in order to provide for a stimulation in the right atrium RA (electrode lead 11), the right ventricle RV (electrode lead 10) and the left ventricle LV (electrode lead 12). In addition, signals indicative of atrial and ventricular activity may be sensed using the electrode leads 10, 11, 12 in order to control a pacing operation, in particular for providing for a cardiac resynchronization therapy.

[0060] By means of a processing circuitry 141 enclosed in a housing 140 of the generator device 14, sensed signals are processed, and stimulation signals are generated and fed to the electrode leads 10, 11, 12 to be output for providing for a stimulation.

[0061] In the setup of Fig. 1, a cardiac resynchronization therapy is performed using the left- ventricular coronary sinus electrode lead 12 in combination with the right-ventricular electrode lead 10 and the atrial electrode lead 11. During operation, signals are received using the different electrode leads 10, 11, 12, and stimulation signals are output using the different electrode leads 10, 11, 12, wherein the operation is adapted such that the specific configuration of the electrode leads 10, 11, 12 and their placement in different regions of the heart H is taken into account. In another setup, as shown in Fig. 2, the generator device 14 is used with a left bundle branch electrode lead 13 comprising a lead body 130 which is implanted to reach into the right ventricle RV of the heart H and with a distal end 131 engages with tissue on the septum M in between the right ventricle RV and the left ventricle LV to engage with the conductive structure of the left bundle branch LBB extending within the septum M. In addition, a right- ventricular electrode lead 10 and an atrial electrode lead 11 is employed in combination with the left bundle branch electrode lead 13.

[0062] In yet another setup as shown in Fig. 3, the left bundle branch electrode lead 13 is used together with an atrial electrode lead 11, without however using a right-ventricular electrode lead 10.

[0063] The configurations of Figs. 1 to 3 show different setups of the implantable medical device 1. For configuring the implantable medical device 1 for operation, different combinations of electrode leads 10-13 can selectively be connected to the generator device 14, such that the generator device 14 may be selectively operated in connection with different combinations of electrode leads 10-13.

[0064] In the configurations of Fig. 2 and 3, instead of the left-ventricular coronary sinus electrode lead 12 of the setup of Fig. 1, the left bundle branch electrode lead 13 is used. By means of the left bundle branch electrode lead 13, a so-called left bundle branch area pacing, in short LBBAP, shall be performed. For this, the electrode lead 13 is implanted such that the lead body 130, with the distal end 131, is placed on tissue on the septum M such that it engages with tissue and reaches into tissue in order to couple to the left bundle branch LBB which, as part of the conductive structure of the patient’s heart H, is coupled via the so-called His bundle to the atrioventricular node AVN and runs in parallel to the right bundle branch RBB. The left bundle branch LBB extends within myocardial tissue around the vertex of the left ventricle LV and conducts excitation signals for exciting tissue in the region of the left ventricle LV.

[0065] The left bundle branch electrode lead 13 comprises an electrode pole which is arranged on and protrudes from the distal end 131 of the lead body 130. The electrode pole is formed e.g. by a helical spiral and is shaped such that it may be screwed into tissue in order to electrically couple to tissue and provide for a mechanical anchoring of the left bundle branch electrode lead 13 on tissue.

[0066] In addition, the left bundle branch electrode lead 13 may comprise one or multiple further electrode poles formed e.g. by a ring electrode arranged proximally with respect to the distal end 131 of the left bundle branch electrode lead 13.

[0067] In an implanted state, as shown in Figs. 2 and 3, the electrode pole on the distal end 131 is engaged with tissue and reaches into tissue such that it electrically couples to the conductive structure within the myocardial tissue of the septum M, in particular the left bundle branch LBB, in order to enable a stimulation of the conductive structure by coupling stimulation signals to the conductive structure.

[0068] During operation of the configurations according to Figs. 2 and 3, by means of an electrode pole arrangement including the electrode poles of a respective set of electrode leads 10, 11, 13 according to the specific setup of the implantable medical device 1, electrical stimulation signals shall be output to couple into tissue in particular in the region of the left bundle branch LBB, such that a spatially differentiated stimulation of the conductive structure of the left bundle branch LBB is obtained, causing a stimulated left-ventricular activity, for example in the context of a cardiac resynchronization therapy (CRT).

[0069] Dependent on the particular setup of the implantable medical device 1, using a left- ventricular coronary sinus electrode lead 12 as in the example of Fig. 1 or, alternatively, using a left bundle branch electrode lead 13 as in the examples of Figs. 2 and 3, parameters for operation need to be adapted in order to allow for a proper functioning of the implantable medical device 1 in its specific setup.

[0070] Generally, a programming of an implantable medical device 1 takes place prior to implantation or once implantation is completed at the initial startup of the implantable medical device 1. For the programming, herein, a configuration unit is used, for example an external device 2 formed e.g. by an external programming device, or a remote device 4, for example at a home monitoring service center, connected to the implantable medical device 1 via a device 2 in proximity to the patient, as shown in Fig. 1. The configuration unit 2, 4 generally is to be operated externally to the patient and allows a user to make modifications to the configuration of the implantable medical device 1, such that parameters for operating the implantable medical device 1 are set and allow for an operation of the implantable medical device 1 making use of the particular setup of electrode leads 10-13 connected to the generator device 14.

[0071] To ease the programming of a configuration of the implantable medical device 1 for a user, it herein is proposed to provide, on a configuration unit 2, 4, a user interface 20 which allows for a mode selection. Namely, as shown in Fig. 4, using the user interface 20 a user may select between different modes by actuating an associated mode selection switch Ml, M2, such that according to the selected mode Ml, M2 a predefined set of parameters is loaded for programming the implantable medical device 1.

[0072] For example, as illustrated in Fig. 5, if a first mode "CS" according to the mode selection switch Ml is selected, the user interface 20 may present a set of parameter selection fields Ml 1-M14 to the user, allowing to adapt certain parameters for the selected mode. The first mode in particular may correspond to an operational mode of the implantable medical device 1 using the setup of electrode leads 10 to 12 of Fig. 1, in particular including a left-ventricular coronary sinus electrode lead 12.

[0073] If, in contrast, a second mode "LBB" according to the mode selection switch M2 is selected, the user interface 20 may present, as illustrated in Fig. 6, a different set of parameter selection fields M21-M26 to the user, allowing the user to adapt a different set of parameters for operation of the implantable medical device 1 in the second mode. The second mode in particular may correspond to an operational mode of the implantable medical device 1 using the setup of electrode leads 10, 11, 13 of Fig. 2 or the setup of electrode leads 11, 13 of Fig. 3, in particular including a left bundle branch electrode lead 13. According to the mode selected in the display view of Fig. 4 by actuating a corresponding mode selection switch Ml, M2, a particular set of parameters associated with the mode may be pre-selected or may be user-selectable.

[0074] For example, the parameter selection fields M11-M14 associated with the first mode corresponding to the setup of Fig. 1 may allow a user to select and / or adapt specific parameters associated with the first mode, wherein other parameters may be automatically set by the system in accordance with the first mode.

[0075] For example, by means of the parameter selection fields Ml 1-M14 it may be possible for a user to select specific vector combinations of the left-ventricular coronary sinus electrode lead 12, which for example comprises four electrode poles and hence allows for a multipole stimulation using different combinations of electrode poles. In the first mode corresponding to the setup of Fig. 1, the right-ventricular electrode lead 10 may for example automatically be selected for providing for a sensing function, for example for providing for an electrocardiogram signal sensing as well as for an impedance measurement, for example for an automatic rate adaption scheme. In addition, by means of the parameter selection fields M11-M14 in the display view of Fig. 5, an option for a biventricular stimulation function for performing a biventricular simulation using the left-ventricular coronary sinus electrode lead 12 as well as the right-ventricular electrode lead 10 may be actuatable by a user.

[0076] If the second mode is selected by the user on the user interface 20 in the display view of Fig. 4, corresponding to the mode selection switch M2, the parameter selection fields M21-M26 associated with the second mode corresponding to the setups of Figs. 2 and 3 may allow a user to select and adapt specific parameters associated with the second mode, wherein other parameters may be automatically set by the system in accordance with the second mode.

[0077] For example, using the parameter selection fields M21-M26 a user may select only vector combinations of the left bundle branch electrode lead 13 for outputting stimulation signals. For example, the left bundle branch electrode lead 13 comprises only two electrode poles, such that a multi-pole stimulation function is prohibited and accordingly in the second mode is deactivated.

[0078] By means of the parameter selection fields M21-M26, a user may for example select whether a ventricular signal sensing shall be performed using the left bundle branch electrode lead 13 and / or the right-ventricular electrode leads 10, such that one or multiple signal sensing vectors may be defined.

[0079] In addition, using the processing circuitry 141 of the generator device 14 it may be automatically detected whether a right-ventricular electrode lead 10 is present, as in the example of Fig. 2, or not, as in the example of Fig. 3. Dependent on whether a right- ventricular electrode lead 10 is present or not, it may be automatically set whether a backup stimulation is enabled using the right-ventricular electrode lead 10, the backup stimulation being performed in case a stimulation by means of the left bundle branch electrode lead 13 fails.

[0080] Also, based on whether a right-ventricular electrode lead 10 is present (as in Fig. 2) or not (as in Fig. 3), it may be automatically defined that an impedance measurement, in particular for an automatic rate adaption scheme, shall be performed using the left bundle branch electrode lead 13 or the right-ventricular electrode lead 10. For example, in the setup of Fig. 2, the right-ventricular electrode lead 10 may be used for impedance measurements, for example in between the electrode pole on the distal end 101 of the lead body 100 of the electrode lead 10 and a counter electrode pole formed by the housing 140 of the generator device 14. In the setup of Fig. 3, in turn, the left bundle branch electrode lead 13 is used for impedance measurements in between the electrode pole on the distal end 131 of the lead body 130 of the electrode lead 13 and a counter electrode pole formed by the housing 140 of the generator device 14.

[0081] Dependent on the selected mode, functional routines may be automatically activated or deactivated. For example, in the setups of Fig. 2 and 3 employing the left bundle branch electrode lead 13, a functional routine for an automatic optimization of a timing of a cardiac resynchronization therapy stimulation may be activated. In contrast, functional routines for a ventricular stimulation suppression, a biventricular stimulation and a left-ventricular T wave suppression may be deactivated, as these functional routines do not provide any technical benefit in the setups of Figs. 2 and 3 employing the left bundle branch electrode lead 13.

[0082] In addition, dependent on the selected mode, a specific capture test routine may be activated. In particular, whereas in the setup of Fig. 1 a capture test routine involving a sensing of a non-specific capture may be employed, in the setups of Figs. 2 and 3 a capture test routine may be used in which a signal processing is employed for identifying a specific capture, namely a specific capture to the left bundle branch LBB resulting in a left-ventricular stimulation.

[0083] The background for this is that during operation electrical stimulation signals shall exhibit a signal energy which is sufficient to cause a reliable stimulation of a desired structure, e.g. the left bundle branch LBB, while avoiding an excessive load of the electrical energy resources of the implantable medical device 1. For this, typically a capture threshold test is carried out at the initial startup of the implantable medical device 1 and repeatedly during operation, for example once or multiple times per day, in order to assess and set a signal strength for an electrical stimulation signal to cause a reliable stimulation of a desired structure.

[0084] For example, during a capture threshold test, electrical stimulation signals are generated and output starting at a maximum start energy, wherein the signal energy is progressively reduced until a capture loss is detected. The signal energy at the capture loss is identified as a capture threshold. The signal energy for the electrical stimulation signal during subsequent operation is then set to a value above the threshold in order to obtain a reliable capture of a desired structure.

[0085] As, in the setups of Figs. 2 and 3, a spatially dedicated stimulation of a certain conductive structure, namely the left bundle branch LBB, shall be established, it is desired to evaluate during the capture threshold test whether a capture of the desired structure is obtained, in comparison to just any capture resulting in any cardiac activity, for example a right- ventricular activity. For this, for example impedance curves may be assessed, which are recorded in response to an electrical stimulation signal in order to evaluate, based on an impedance curve, whether a desired structure is effectively stimulated as a result of the outputting of the electrical stimulation signal. Based on impedance measurements it hence is assessed what type of capture is obtained, such that during a capture threshold test it not only may be assessed whether a capture is obtained at all, but also what type of capture is present. This is based on the finding that an impedance curve measured in response to an electrical stimulation signal substantially depends on the contraction event resulting from the stimulation. Namely, a stimulation causing a cardiac contraction of both the left ventricle and the right ventricle will result in an impedance curve which substantially differs from an impedance curve for a stimulation resulting in a right-ventricular contraction alone or a left- ventricular contraction alone. By assessing the shape of an impedance curve measured in response to and in correlation with an electrical stimulation signal, hence, the effectiveness of a stimulation may be assessed, and it may be determined whether a capture of a desired type, namely a capture to the left bundle branch LBB, is obtained.

[0086] In other embodiments, for a capture test sense signals of different signal reception vectors may be processed and compared in order to derive spatially differentiated information indicative of ventricular activity.

[0087] Because for the programming of the implantable medical device 1 a user selects, on a user interface 20 of a configuration unit 2, 4, a mode which specifies a particular configuration of the implantable medical device 1 and loads a pre-defined set of parameters in connection with the selected mode, a programming for setting up the implantable medical device 1 at the initial start-up may be eased. In particular, a user may select a particular mode and, as a consequence, an associated set of parameters is automatically set and / or is presented to the user for adaption, such that the user may easily review and modify those parameters which need adaption in the specific mode, whereas other parameters are automatically set or automatically activated or deactivated. A programming in particular for an LBBAP setup hence becomes easy and less susceptible for errors. List of reference numerals

[0088] 1 Implantable medical device

[0089] 10 Right-ventricular electrode lead

[0090] 100 Lead body

[0091] 101 Distal end

[0092] 11 Atrial electrode lead

[0093] 110 Lead body

[0094] 111 Distal end

[0095] 12 Coronary sinus electrode lead

[0096] 120 Lead body

[0097] 121 Distal end

[0098] 13 LBBAP electrode lead

[0099] 130 Lead body

[0100] 131 Distal end

[0101] 14 Generator device

[0102] 140 Housing

[0103] 141 Processing circuitry

[0104] 2 Configuration unit (external programming device)

[0105] 20 User interface

[0106] 3 Communication network (internet)

[0107] 4 Configuration unit (home monitoring service center)

[0108] AVN AV node

[0109] B Blockage

[0110] CS Coronary sinus

[0111] H Heart

[0112] LA Left atrium

[0113] LBB Left bundle branch

[0114] LV Left ventricle

[0115] M Septum

[0116] Ml -M3 Mode selection switch

[0117] Ml 1-M14 Parameter selection field M21-M26 Parameter selection field

[0118] RA Right atrium

[0119] RBB Right bundle branch

[0120] RV Right ventricle

Claims

Claims1. A system for providing for a cardiac resynchronization therapy, comprising: an implantable medical device (1) comprising a generator device (10) having a processing circuitry (100) for controlling operation of the generator device (10), wherein the implantable medical device (1) is configured to be selectively connected to a left-ventricular coronary sinus electrode lead (12) configured for implantation on the left ventricle (LV) through the coronary sinus (CS) or to a left bundle branch electrode lead (13) configured for implantation on the cardiac septum (M) to engage with the conductive structure of the left bundle branch (LBB), and a configuration unit (2, 4) having a user interface (20) to modify a configuration of the implantable medical device (1), characterized in that the user interface (20) is user-actuatable to select a first mode or a second mode out of at least two modes for configuring the implantable medical device (1), wherein in the first mode a first set of parameters is pre-selected or user-selectable for configuring the implantable medical device (1) to function with the left-ventricular coronary sinus electrode lead (12) and in the second mode a second set of parameters is pre-selected or user-selectable for configuring the implantable medical device (1) to function with the left bundle branch electrode lead (13).

2. The system according to claim 1, characterized in that the configuration unit (2, 4) is a programming device (2) to be operated externally to a patient for programming the configuration of the implantable medical device (1), or a remote device (4) to be operated remotely from the patient and being in communication connection with the implantable medical device (1) using a public communication network (3).

3. The system according to claim 1 or 2, characterized in that the user interface (20) is user-actuatable to adapt, in case of a selection of the first mode using the user interface (20), at least one parameter of the first set of parameters and, in case of a selection of the second mode using the user interface (20), at least one parameter of the second set of parameters.

4. The system according to one of claims 1 to 3, characterized in that the first set of parameters and the second set of parameters each define at least one of a value for at least one functional parameter, an allowable range for at least one functional parameter and an activation or deactivation of at least one functional routine.

5. The system according to one of the preceding claims, characterized in that the first set of parameters and the second set of parameters each define at least one of an electrode lead to be used for outputting a stimulation signal, an electrode lead to be used for an electrocardiogram signal sensing and an electrode lead to be used for an impedance measurement.

6. The system according to one of the preceding claims, characterized in that the first set of parameters and the second set of parameters each define an activation or deactivation of at least one of a ventricular stimulation suppression function, a biventricular stimulation function, a left-ventricular T wave protection function, and a CRT optimization function.

7. The system according to claim 6, characterized in that the second set of parameters of the second mode defines a deactivation of at least one of the ventricular stimulation suppression function, the biventricular stimulation function, and the left-ventricular T wave protection function.

8. The system according to claim 6 or 7, characterized in that the second set of parameters of the second mode defines a deactivation of the ventricular stimulation suppression function, the biventricular stimulation function and the left-ventricular T wave protection function.

9. The system according to one of claims 6 to 8, characterized in that the second set of parameters of the second mode defines an activation of the CRT optimization function.

10. The system according to one of the preceding claims, characterized in that the first set of parameters defines a first capture test configuration for defining a capturethreshold using a sensing of a non-specific capture, and the second set of parameters defines a second capture test configuration for defining a capture threshold using a sensing of a specific capture of a left bundle branch area pacing.

11. The system according to one of the preceding claims, characterized in that the implantable medical device (1) is configured to be selectively connected to a right- ventricular electrode lead (10) configured for implantation in the right ventricle (RV).

12. The system according to claim 11, characterized in that the second set of parameters of the second mode is pre-selected or user-selectable for configuring the implantable medical device (1) to function with the left bundle branch electrode lead (13) in combination with the right-ventricular electrode lead (10).

13. The system according to claim 11, characterized in that the second set of parameters of the second mode is pre-selected or user-selectable for configuring the implantable medical device (1) to function with the left bundle branch electrode lead (13) not in combination with the right-ventricular electrode lead (10).

14. The system according to one of claims 11 to 13, characterized in that the first set of parameters and the second set of parameters each define an activation or deactivation of a backup stimulation function using the right-ventricular electrode lead (10).

15. A method for operating a system for providing for a cardiac resynchronization therapy, comprising: providing an implantable medical device (1) comprising a generator device (10) having a processing circuitry (100) for controlling operation of the generator device (10), selectively connecting the implantable medical device (1) to a left-ventricular coronary sinus electrode lead (12) configured for implantation through the coronary sinus or to a left bundle branch electrode lead (13) configured for implantation on the cardiac septum (M) to engage with the conductive structure of the left bundle branch (LBB), andmodifying a configuration of the implantable medical device (1) using a configuration unit (2, 4) having a user interface (20), characterized by: selecting a first mode or a second mode out of at least two modes for configuring the implantable medical device (1) by user-actuation of the user interface (20), wherein in the first mode a first set of parameters is pre-selected or user- selectable for configuring the implantable medical device (1) to function with the left- ventricular coronary sinus electrode lead (12) and in the second mode a second set of parameters is pre-selected or user-selectable for configuring the implantable medical device (1) to function with the left bundle branch electrode lead (13).

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