A programming device for programming an implantable medical device for stimulating a human or animal heart

By generating notification signals through a programming device, the risk of parameter adjustment in conventional pacemakers under atypical electrode lead configurations is eliminated, enabling safe operation under atypical configurations, especially effective stimulation of the ventricular conduction system, thus improving the safety and reliability of cardiac treatment.

CN114568019BActive Publication Date: 2026-01-27BIOTRONIK SE & CO KG
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Patent Information

Application Number
CN202080073536.X
Authority / Receiving Office
CN · China
Patent Type
Patents(China)
Current Assignee / Owner
Priority Date
2019-10-24
Filing Date
2020-10-22
Publication Date
2026-01-27
Estimated Expiration
2040-10-22

AI Technical Summary

Technical Problem

In the existing technology, there are risks when adjusting stimulation parameters of conventional pacemakers with atypical electrode lead configurations, which can lead to reduced cardiac treatment efficiency and put patients at risk.

Method used

A programming device is provided that, through a first processor and a storage unit, generates a notification signal when two electrode lead configurations (typical and atypical) are selected, ensuring that the user of the programming device and the implantable medical device is aware of the electrode lead configuration and reducing the risk of inappropriate parameter application.

Benefits of technology

This ensures safe operation of implantable medical devices, particularly those stimulating the ventricular conduction system of the heart, even with atypical electrode lead configurations, reducing the risk of inappropriate parameter application and improving operational safety and reliability.

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Abstract

The invention relates to a programming device for programming an implantable medical device for stimulating a human or animal heart. In operation, the following steps are performed: a) allowing selection of one of at least two electrode lead configurations of the implantable medical device (1) for stimulating the human or animal heart (7), wherein the at least two electrode lead configurations comprise a second electrode lead configuration, wherein at least one electrode lead (4) of the implantable medical device (1) is connected to an electrode lead port (3) of the implantable medical device (1), the electrode lead port (3) being configured to receive an electrode lead (4) for stimulating a second heart region or for detecting electrical signals at the second heart region, wherein the second heart region is part of a ventricular conduction system of the heart (7), wherein the at least one electrode lead (4) is implanted or is intended to be implanted in the second heart region; b) generating and releasing a notification signal if the second electrode lead configuration is selected.
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Description

Technical Field

[0001] The present invention relates to a programming device, a computer program product, an apparatus including such a programming device and an implantable medical device, and a method for programming an implantable medical device using such a programming device. Background Technology

[0002] Implantable medical devices, such as pacemakers, used to stimulate the hearts of humans or animals have been known for a long time. They can perform different functions. Different stimulation programs can be performed by appropriate pacemakers to restore the treated heart to a normal state. It is also known that cardiac pacemakers stimulate the His bundle.

[0003] The His bundle is a specific bundle of myocardial cells that is part of the heart's conduction system. It is located distal to the atrioventricular node, towards the apex of the heart. The His bundle forms part of the ventricular conduction system.

[0004] There are specific devices available for His bundle pacing in which the sensing and stimulating electrodes are implanted not in the ventricles of the heart of the person or animal being treated, but in or near the His bundle of the heart. This use of His bundle electrodes enables specific physiological stimulation of the human or animal heart.

[0005] In many cases, conventional pacemakers are used for His bundle pacing. In this situation, the ports to which the His bundle electrodes are connected are configured with specific stimulation / sensing parameters to achieve proper sensing of the electrical signal at the His bundle and to allow adequate, yet still physiological, stimulation of the His bundle during His bundle pacing. If the stimulation parameters are adjusted at a later stage (e.g., during follow-up care), there is a risk of selecting conventional stimulation / sensing parameters instead of those specifically suited for His bundle pacing (e.g., because the attending physician was unaware that the pacemaker was implanted for His bundle pacing). In such cases, stimulation efficiency will be lost, and the patient will be at risk. Summary of the Invention

[0006] The object of the present invention is to provide a possibility that implantable medical devices for stimulating the heart of humans or animals can be safely operated even when using atypical electrode lead configurations, such as those suitable for His bundle pacing.

[0007] This objective is achieved by a programming device for programming an implantable medical device used to stimulate the heart of a human or animal. Such a programming device includes a first processor and a first storage unit. The first storage unit includes a first computer-readable program, which, when executed on the first processor, causes the first processor to perform the steps explained below.

[0008] In the first step, it is possible to select from at least two electrode lead configurations for use in an implantable medical device for stimulating the heart of a human or animal. In this case, the at least two electrode lead configurations include a first electrode lead configuration and a second electrode lead configuration.

[0009] In a first electrode lead configuration, each electrode lead of the implantable medical device is connected to an electrode lead port of the implantable medical device. In this case, the electrode lead port is configured to receive an electrode lead for stimulating a first cardiac region or for detecting an electrical signal at the first cardiac region. The first cardiac region is at least one region selected from the atrium, left ventricle, and right ventricle (excluding the ventricular conduction system) of the heart from which an electrical signal is to be detected. Each electrode lead is implanted or intended to be implanted into the cardiac region corresponding to the first cardiac region to which the electrode lead port to which the electrode lead is connected. For example, if the electrode lead port is used to receive an electrode lead to be implanted in the right atrium of the heart, then the electrode lead is connected to the electrode lead port to which the right atrium is actually implanted or implanted. Therefore, considering the (intended) location of the electrode lead implantation, each electrode lead is connected to the electrode lead port initially intended to receive the corresponding electrode. Thus, the first electrode lead configuration can also be represented as a typical electrode lead configuration.

[0010] In the second electrode lead configuration, at least one electrode lead of the implantable medical device is connected to the electrode lead port of the implantable medical device. However, in this case, the electrode lead port is configured to receive an electrode lead for stimulating a second cardiac region or for detecting electrical signals at the second cardiac region. The second cardiac region is part of the heart's ventricular conduction system (but not the atrium, right ventricle, or left ventricle itself). Furthermore, at least one electrode lead is intended to be implanted in the second cardiac region. Typically, the heart's ventricular conduction system is not in direct contact with the electrode leads of the implantable medical device used to stimulate the human or animal heart. Therefore, this second electrode lead configuration can also be represented as an atypical electrode lead configuration. It can also be applied to situations where the implantable medical device includes an electrode lead port that is originally intended to receive electrodes for stimulating the atrium, right ventricle, or left ventricle of the heart, or to receive electrical signals from these cardiac regions. In this case, the electrode lead can still be connected to the electrode lead port, wherein the electrode lead is implanted or intended to be implanted in the second cardiac region, i.e., part of the heart's ventricular conduction system. Then, sensing / stimulation parameters applied to the electrode leads via the electrode lead ports are specifically adapted to the atypical site where the electrode leads are implanted, resulting in a specific configuration of the corresponding electrode lead ports.

[0011] The second electrode lead configuration is an electrode lead configuration that is not typically desired in implantable medical devices used to stimulate the heart of a human or animal. Instead, in most cases, the first electrode lead configuration, i.e., the typical electrode lead configuration, may be present in such implantable medical devices.

[0012] If a second electrode lead configuration is selected, a notification signal is generated and released. This notification signal helps inform the user of the programming device and / or the relevant implantable medical device on the second electrode lead configuration, allowing subsequent programming operations performed using the programming device to be completed in consideration of the selected electrode lead configuration.

[0013] Therefore, the risk of accidentally applying sensing / stimulation parameters that are applicable to typical electrode lead configurations (such as the first electrode lead configuration) but not to atypical electrode lead configurations (such as the second electrode lead configuration) to implantable medical devices that include atypical electrode lead configurations is significantly reduced. Thus, the programming device enables the safe operation of implantable medical devices that can operate with atypical electrode lead configurations, i.e., implantable medical devices used to stimulate a portion of the ventricular conduction system of the heart.

[0014] In one embodiment, the notification signal includes at least one of the following: notification of the selected electrode lead configuration, information about the selected electrode lead configuration, a warning, a specific color, and a specific sound. Therefore, it is possible to apply visual or auditory aids to make the generated and released notification signals more readily apparent to the human user of the programming device. A combination of a graphic notification and a specific color of that graphic notification is a particularly suitable visual aid for describing the notification signal.

[0015] In one embodiment, the second cardiac region is selected from at least one of the His bundle and the left bundle branch. The left bundle branch is part of the His bundle and thus forms part of the ventricular conduction system. His bundle pacing becomes possible if an electrode lead is implanted at or near the His bundle. Left bundle branch pacing is possible if an electrode lead is implanted in or near the left bundle branch. These two pacing methods of the ventricular conduction system are specific physiological forms of stimulating the heart.

[0016] In one embodiment, if a first electrode lead configuration is selected, a first computer-readable program causes a first processor not to generate a notification signal. Therefore, the notification signal can be considered a flag that is set when a second electrode lead configuration is selected and not set when the first electrode lead configuration is selected.

[0017] In one embodiment, at least one additional electrode lead of the implantable medical device is connected to an additional electrode lead port of the implantable medical device in a second electrode lead configuration. In this case, the additional electrode lead port is configured to receive an electrode lead for stimulating a first cardiac region or for detecting an electrical signal at the first cardiac region. Furthermore, at least one additional electrode lead is implanted or intended to be implanted in the first cardiac region. As described above, the first cardiac region is a region selected from the atrium, right ventricle (excluding the ventricular conduction system), and left ventricle of the respective heart. Therefore, it is possible that not only an electrode lead for stimulating the ventricular conduction system is present in the second electrode lead configuration, but also other electrode leads implanted at typical implantation sites such as the right atrium, right ventricle, and / or left ventricle.

[0018] In one embodiment, the second electrode lead configuration includes an atrial electrode lead and a His bundle electrode lead. The atrial electrode lead is implanted or intended to be implanted in the right atrium of the heart to be stimulated. Furthermore, the atrial electrode lead is connected to an atrial electrode lead port for implantable medical devices. The His bundle electrode lead is implanted or intended to be implanted in or near the His bundle of the same heart and connected to a right ventricular electrode lead port or a His bundle electrode lead port. If the right ventricular electrode lead port is used to receive the His bundle electrode lead, it is specifically configured for His bundle pacing such that the applied sensing / stimulation parameters are particularly suitable for sensing electrical signals at the His bundle or stimulating the His bundle of the heart.

[0019] In one embodiment, the second electrode lead configuration includes an atrial electrode lead, a left ventricular electrode lead, and a His bundle electrode lead. The atrial electrode lead is connected to an atrial electrode lead port of an implantable medical device. The His bundle electrode lead is connected to a right ventricular electrode lead port or a His bundle electrode lead port. The left ventricular electrode lead is implanted in the apical region of the left ventricle and connected to a left ventricular electrode lead port of an implantable medical device. This electrode lead configuration is particularly suitable for cardiac resynchronization therapy.

[0020] In one embodiment, the second electrode lead configuration includes an atrial electrode lead, a His bundle electrode lead, and a right ventricular electrode lead. The atrial electrode lead is connected to an atrial electrode lead port of the implantable medical device. The His bundle electrode lead is connected to a right ventricular electrode lead port or a His bundle electrode lead port. The right ventricular electrode lead is implanted or intended to be implanted into the right ventricle in its apical region. Furthermore, it is connected to the right ventricular electrode port (if the right ventricular electrode port is still available and not occupied by the His bundle electrode lead). Otherwise, the right ventricular electrode lead is connected to a left ventricular electrode port of the implantable medical device. In this case, sensing / stimulation parameters are applied to the left ventricular electrode lead port, which is adapted to operate the connected right ventricular electrode lead. This electrode lead configuration enables right ventricular backup stimulation. For example, this backup stimulation may be useful if the anticipated His bundle pacing proves insufficient to achieve typical cardiac contraction.

[0021] In one embodiment, the second electrode lead configuration includes the setup explained below. On one hand, the implantable medical device to be programmed includes only a single electrode lead port, namely the first electrode lead port. On the other hand, a His bundle electrode lead is connected to the first electrode lead port. This second electrode lead configuration is adapted to configure a single-chamber implantable medical device for His bundle pacing.

[0022] In one embodiment, the second electrode lead configuration includes the following setup. On one hand, the implantable medical device to be programmed includes exactly two electrode ports, namely a first electrode lead port and a second electrode lead port. On the other hand, a His bundle electrode lead is connected to the first electrode lead port, and a right atrial electrode is connected to the second electrode lead port. This second electrode lead configuration is particularly suitable for dual-chamber implantable medical devices especially suitable for His bundle pacing.

[0023] In one embodiment, the second electrode lead configuration includes the setup explained below. On one hand, the implantable medical device to be programmed includes exactly three electrode lead ports: a first electrode lead port, a second electrode lead port, and a third electrode lead port. On the other hand, in this embodiment, three different specific electrode configurations are possible.

[0024] In the first configuration, the His bundle electrode is connected to the first electrode lead port, with no electrode connected to the second electrode lead port. Additionally, the right ventricular electrode lead is connected to the third electrode lead port. This configuration is particularly suitable for three-chamber implantable medical devices specifically designed for His bundle pacing, where the right ventricular electrode serves as a backup His bundle electrode lead. This configuration can be used in cases of atrioventricular node ablation where proper atrial sensing / pacing is no longer possible.

[0025] In the second configuration, the His bundle electrode is connected to the first electrode lead port, the right atrial electrode lead is connected to the second electrode lead port, and the right ventricular electrode lead is connected to the third electrode lead port. This setup is suitable for physiological His bundle pacing with the right ventricular electrode as a backup His bundle electrode lead.

[0026] In the third configuration, the His bundle electrode leads are connected to the first electrode lead port, the right atrial electrode lead is connected to the second electrode lead port, and the left ventricular electrode lead is connected to the third electrode lead port. This configuration is particularly suitable for cardiac resynchronization therapy.

[0027] In each of the second electrode lead configurations explained above, a His bundle electrode lead is present. In other embodiments, the His bundle electrode lead is replaced by a left bundle branch electrode lead or another ventricular conduction system electrode lead, while other electrodes are maintained as described above. In one embodiment, both a His bundle electrode lead and a left bundle branch electrode lead are present, along with other electrode leads as described above.

[0028] In one embodiment, a first computer-readable program enables a first processor to make a notification signal permanently available to the user of the programming device. This permanent availability guarantees, in a particularly reliable manner, a significantly reduced risk of applying inappropriate electrode configurations to the associated implantable medical device using the programming device. This permanent availability of the notification signal can be achieved, for example, by displaying information about the generated notification signal on the graphical user interface of the programming device. This information can be displayed, for example, on the start screen of the graphical user interface, or on one or more (particularly all) subpages of the graphical user interface. Particularly suitable is that this information about the generated notification signal is displayed on a portion of the graphical user interface used to assign a specific electrode configuration to the implantable medical device.

[0029] In one embodiment, the generated notification signal restricts the possibility of selecting an electrode lead configuration other than the second electrode lead configuration. In another embodiment, the generated notification signal needs to be reset before an electrode lead configuration different from the second electrode lead configuration can be selected.

[0030] In one embodiment, if a (first) notification signal has already been generated, another notification signal is generated and released if the electrode lead configuration of the implantable medical device is changed to an electrode lead configuration different from the second electrode lead configuration. In this case, the user will generally be able to change the electrode lead configuration of the implantable medical device, but will be faced with a further notification signal if the original notification signal has already been set in the past.

[0031] In one embodiment, a first computer-readable program causes a first processor to transmit a notification signal to an appliance remote from the programming device. In doing so, the notification signal may be converted into a data form conceived by the appliance or by the appliance user. However, it is also possible to transmit the notification signal to the appliance without conversion. The appliance is selected from the group consisting of printouts (or printers used to produce printouts), databases, and home monitoring systems. A particularly suitable database is one that includes electronic health records (EHRs). For example, a clinic information system might be a suitable database. When the notification signal is transmitted to such an appliance, the notification signal will be available in the appliance at a later point in time. Identifying the electrode lead configuration of a specific implantable medical device is then particularly easy, even if the programming device may not be available at that point in time.

[0032] In one embodiment, if a first electrode lead configuration is selected, a first computer-readable program causes a first processor to enable a first set of programming functions, and if a second electrode lead configuration is selected, a second set of programming functions is enabled. Therefore, the programming device enables different sets of programming functions depending on the selected electrode lead configuration. In doing so, particularly suitable sensing / stimulation parameters can be selected or adjusted for the selected electrode lead configuration. Thus, if the first electrode lead configuration is selected, specific parameters can be adjusted, and if the second electrode lead configuration is selected, different parameters can be adjusted.

[0033] In one embodiment, at least one additional electrode lead of the implantable medical device is connected to an additional electrode lead port of the implantable medical device via a second electrode lead configuration. In this embodiment, the additional electrode lead port is configured to receive an electrode lead for stimulating a first cardiac region (i.e., the atrium, right ventricle, or left ventricle of the heart) or for detecting electrical signals at the first cardiac region. Furthermore, at least one additional electrode lead is implanted or intended to be implanted in the first cardiac region. Additionally, a first computer-readable program causes a first processor to adjust a second set of programming functions based on the selection of the first cardiac region, i.e., whether at least one additional electrode lead is implanted (or intended to be implanted) in the atrium, right ventricle, or left ventricle of the heart. Therefore, this embodiment allows for very specific adjustments to the programming surface to facilitate user programming of the implantable medical device. Unnecessary functions can be disabled, while necessary or optional functions for a specific electrode lead configuration selected for the implantable medical device can be activated. Then, considering the specific electrode lead configuration of the implantable medical device to be programmed with the programming device, very specific modifications can be made to the sensing / stimulation parameters.

[0034] In one aspect, the present invention relates to a computer program product comprising computer-readable code that, when executed on a processor, causes the processor to perform the steps explained below.

[0035] In the first step, it is possible to select from at least two electrode lead configurations for use in an implantable medical device for stimulating the heart of a human or animal. In this case, the at least two electrode lead configurations include a first electrode lead configuration and a second electrode lead configuration.

[0036] In the first electrode lead configuration, each electrode lead of the implantable medical device is connected to an electrode lead port of the implantable medical device. In this configuration, the electrode lead port is configured to receive an electrode lead for stimulating a first cardiac region or for detecting an electrical signal at the first cardiac region. The first cardiac region is at least one region selected from the atria, left ventricle, and right ventricle (excluding the ventricular conduction system) of the heart from which an electrical signal is to be stimulated or from which an electrical signal is to be detected. Each electrode lead is implanted, or is intended to be implanted, into a cardiac region corresponding to the first cardiac region to which the electrode lead port to which the electrode lead is connected.

[0037] In the second electrode lead configuration, at least one electrode lead of the implantable medical device is connected to the electrode lead port of the implantable medical device. However, in this case, the electrode lead port is configured to receive an electrode lead for stimulating a second cardiac region or for detecting an electrical signal at the second cardiac region. The second cardiac region is part of the heart's ventricular conduction system (but not the atria, right ventricle, or left ventricle themselves). Furthermore, at least one electrode lead is intended to be implanted in the second cardiac region. Typically, the heart's ventricular conduction system is not in direct contact with the electrode leads of the implantable medical device used to stimulate the human or animal heart. Therefore, this second electrode lead configuration can also be represented as an atypical electrode lead configuration.

[0038] If the second electrode lead configuration is selected, a notification signal is generated and released.

[0039] In one aspect, the present invention relates to a programming device according to the foregoing explanation and an apparatus for stimulating the heart of a human or animal. In addition to the components explained above, the programming device includes a first data communication unit. Furthermore, the implantable medical device includes a second processor, a second storage unit, a second data communication unit, a stimulation unit, and a detection unit. The stimulation unit is configured to stimulate a cardiac region of the human or animal heart. The detection unit is configured to detect electrical signals at a cardiac region of the same heart. Both the stimulation unit and the detection unit include electrode leads. The electrode leads may be the same or different for the stimulation unit and the detection unit. With this apparatus, the implantable medical device can be programmed using the programming device, for example, to set specific stimulation / sensing parameters.

[0040] In one embodiment, the active implantable medical device is an implantable pulse generator (IPG), an implantable cardioverter defibrillator (ICD), or a cardiac resynchronization therapy device (CRT).

[0041] In one embodiment, the first data communication unit and the second data communication unit are used to transmit data from the programming device to the implantable medical device and / or in the opposite direction, i.e., from the implantable medical device to the programming device. Therefore, the programming device can be used not only to program the implantable medical device but also to read specific settings of the implantable medical device.

[0042] In one embodiment, the data communication unit is used to transmit data wirelessly. All standard data transmission protocols or specifications are applicable to this wireless data communication. Examples of standard data transmission protocols or specifications are Medical Device Radio Communication Service (MICS), Bluetooth Low Energy (BLE) protocol, and Zigbee specification.

[0043] In one embodiment, the second memory unit includes a second computer-readable program that, when executed on a second processor, causes the second processor to perform the steps explained below.

[0044] First, a dataset is received using a second data communication unit. This dataset includes appropriate sensing and / or stimulation parameters for the electrode lead configuration of the implantable medical device selected on the programming device.

[0045] Then, the sensing parameters of the detection unit are set using the received dataset (if the dataset includes appropriate sensing parameters). Alternatively, the stimulation parameters of the stimulation unit are set using the received dataset (if the received dataset includes appropriate stimulation parameters).

[0046] In one embodiment, the second memory unit includes a second computer-readable program that, when executed on a second processor, causes the second processor to perform the steps explained below.

[0047] In the first step, the presence of a second cardiac region electrode lead is automatically detected. This second cardiac region electrode lead is configured to stimulate the second cardiac region and / or detect electrical signals at the second cardiac region. As mentioned above, the second cardiac region is part of the heart's ventricular conduction system. Furthermore, the second cardiac region electrode is implanted or is intended to be implanted in the second cardiac region.

[0048] Alternatively, a dataset indicating the presence of the second cardiac region electrode is received from a second memory unit. This dataset can be generated by a programming device and transferred to the implantable medical device after selecting a suitable electrode lead configuration within the programming device. It is then stored in the second memory unit.

[0049] In a further step, the second data communication unit transmits a dataset indicating the presence of the second cardiac region electrode lead to the first data communication unit. Therefore, the implantable medical device can proactively notify the programming device of the presence of the second cardiac region electrode lead, thereby automatically performing the selection of electrode lead configuration to be performed on the programming device based on this transmitted dataset.

[0050] More precisely, in one embodiment, a first computer-readable program causes a first processor to perform the steps explained below. First, a dataset indicating the presence of a second cardiac region electrode lead is received using a first data communication unit. Then, in response to receiving the dataset, a second electrode lead configuration is automatically selected.

[0051] This embodiment is particularly suitable if a suitable electrode lead configuration has been selected and stored in the implantable medical device at an earlier point in time. If a data connection is established between the implantable medical device and the programming device at a later stage, the programming device can automatically receive information about the presence of the second cardiac region electrode lead and can therefore automatically select the second electrode configuration for subsequent programming purposes. In this case, selecting the correct electrode lead configuration becomes particularly easy and reliable. This enhances the overall operational safety of the corresponding implantable medical device.

[0052] In one aspect, the present invention relates to a method for programming an implantable medical device for stimulating the heart of a human or animal using a programming device as described above. In addition to the components described above, the programming device includes a first data communication unit. Furthermore, the implantable medical device includes a second processor, a second storage unit, a second data communication unit, a stimulation unit, and a detection unit. The stimulation unit is configured to stimulate a cardiac region of the human or animal heart. The detection unit is configured to detect electrical signals at a cardiac region of the same heart. The stimulation unit and the detection unit include electrode leads. The electrode leads may be the same or different for the stimulation unit and the detection unit. The method includes the steps described below.

[0053] First, a dataset is generated using a programming device. This dataset includes appropriate sensing and / or stimulation parameters for selecting electrode lead configurations on the programming device.

[0054] Subsequently, the first data communication unit is used to transmit the dataset to the implantable medical device.

[0055] It can be implanted in medical devices and then use a second data communication unit to receive datasets.

[0056] Then, the sensing parameters of the detection unit and / or the stimulation parameters of the stimulation unit are set using the received dataset.

[0057] All embodiments of the described programming device can be combined in any desired manner and can be transferred individually or in any arbitrary combination to the device, computer program product, and method. Similarly, all embodiments described with respect to the device can be combined in any desired manner and can be transferred individually or in any arbitrary combination to the described programming device, described computer program product, and described method. Likewise, all embodiments described with respect to the computer program product can be combined in any desired manner and can be transferred individually or in any arbitrary combination to the described programming device, described device, and described method. Finally, all embodiments described with respect to the method can be combined in any desired manner and can be transferred individually or in any arbitrary combination to the described programming device, device, and computer program product. Attached Figure Description

[0058] Further details of the invention will now be described with reference to exemplary embodiments and accompanying drawings.

[0059] Figure 1 The device shown includes a pacemaker and a programming device. Detailed Implementation

[0060] Figure 1 An apparatus is shown that serves as a pacemaker 1 and a programming device 2 for use as an implantable medical device. The pacemaker 1 includes a port 3 serving as an electrode lead port into which His bundle electrode leads 4 are inserted. The His bundle electrode leads 4 include an electrode post 5 at its distal end, which is implanted at the His bundle 6 of a human heart 7.

[0061] The programming device 2 includes a display 8 for user interaction with the programming device 2. The programming device 2 and the pacemaker 1 are operatively coupled to each other via radio communication 9. This radio communication 9 is established by a first data communication unit in the programming device 2 and a second data communication unit in the pacemaker 1. Due to this radio communication 9, it is possible to program the pacemaker 1 using the programming device 2.

[0062] To perform this programming, the programming device 2 first requests a selection between two electrode lead configurations. The first electrode lead configuration is a standard configuration with both atrial and right ventricular electrode leads. The second electrode lead configuration is one in which His bundle electrode leads are present. In this embodiment, the His bundle electrode 4 is connected to the pacemaker 1, thereby selecting the second electrode lead configuration. This automatically results in the generation of a notification signal stored in the software of the programming device 2. Furthermore, information about this notification signal is displayed on the display 8 of the programming device 2.

Claims

1. An apparatus comprising a programming device and an implantable medical device, the programming device being configured to program the implantable medical device for stimulating the heart of a human or animal, the apparatus further comprising a first processor and a first storage unit. Its features are, The first storage unit includes a first computer-readable program, which, when executed on the first processor, causes the first processor to perform the following steps: a) Allows selection of at least two electrode lead configurations for an implantable medical device (1) used to stimulate the heart (7) of a human or animal, wherein the at least two electrode lead configurations include: i) A first electrode lead configuration, wherein each electrode lead of the implantable medical device is connected to an electrode lead port of the implantable medical device (1), the electrode lead port being configured to receive an electrode lead for stimulating or detecting an electrical signal at a first cardiac region, wherein the first cardiac region is at least one selected from the atrium, left ventricle, and right ventricle, wherein each electrode lead is implanted or intended to be implanted in a cardiac region corresponding to the first cardiac region to which the electrode lead port to which the electrode lead is connected, and ii) A second electrode lead configuration wherein at least one electrode lead (4) of the implantable medical device (1) is connected to an electrode lead port (3) of the implantable medical device (1), the electrode lead port (3) being configured to receive the electrode lead (4) for stimulating or detecting an electrical signal at the second cardiac region, wherein the second cardiac region is part of the ventricular conduction system of the heart (7), wherein at least one electrode lead (4) is implanted or intended to be implanted in the second cardiac region, wherein the second cardiac region is at least one selected from the His bundle (6) and the left bundle branch. b) When the second electrode lead configuration is selected, a notification signal is generated and released, and c) Stimulating the heart of a human or animal via activation of the implantable medical device. When the first electrode lead configuration is selected, the first computer-readable program causes the first processor not to generate a notification signal.

2. The apparatus according to claim 1, characterized in that, In the second electrode lead configuration, at least one additional electrode lead of the implantable medical device is connected to an additional electrode lead port of the implantable medical device, the additional electrode lead port being configured to receive an electrode lead for stimulating the first cardiac region or detecting an electrical signal at the first cardiac region, wherein at least one additional electrode lead is implanted or intended to be implanted in the first cardiac region.

3. The apparatus according to claim 1 or 2, characterized in that, The first computer-readable program enables the first processor to make the notification signal permanently available to the user of the programming device.

4. The apparatus according to claim 1 or 2, characterized in that, The first computer-readable program causes the first processor to transmit the notification signal to an appliance remote from the programming device, the appliance being selected from the group consisting of a printer, a database, and a home monitoring system.

5. The apparatus according to claim 2, characterized in that, When the first electrode lead configuration is selected, the first computer-readable program enables the first processor to enable a first set of programming functions, and when the second electrode lead configuration is selected, enables a second set of programming functions.

6. The apparatus according to claim 5, characterized in that, In the second electrode lead configuration, at least one additional electrode lead of the implantable medical device (1) is connected to an additional electrode lead port of the implantable medical device (1), the additional electrode lead port being configured to receive an electrode lead for stimulating the first heart region or detecting an electrical signal at the first heart region, wherein at least one additional electrode lead is implanted or intended to be implanted in the first heart region, and the first computer-readable program causes the first processor to adjust the second set of programming functions according to the selection of the first heart region.

7. The apparatus of claim 1, wherein the programming device (2) includes a first data communication unit, and wherein the implantable medical device (1) includes a second processor, a second storage unit, a second data communication unit, a stimulation unit and a detection unit, wherein the stimulation unit is configured to stimulate a cardiac region of a human or animal heart (7), and the detection unit is configured to detect an electrical signal at a cardiac region of the same heart (7), wherein the stimulation unit and the detection unit include electrode leads (4).

8. The apparatus according to claim 7, characterized in that, The first data communication unit and the second data communication unit are used to transmit data from the programming device (2) to the implantable medical device (1) and / or transmit data from the implantable medical device (1) to the programming device (2).

9. The apparatus according to claim 7 or 8, characterized in that, The second storage unit includes a second computer-readable program, which, when executed on the second processor, causes the second processor to perform the following steps: a) Receive a dataset using the second data communication unit, the dataset including applicable sensing parameters and / or stimulation parameters for an electrode lead configuration selected on the programming device (2); b) Set the sensing parameters of the detection unit and / or the stimulation parameters of the stimulation unit by using the received dataset.

10. The apparatus according to claim 7 or 8, characterized in that, The second storage unit includes a second computer-readable program, which, when executed on the second processor, causes the second processor to perform the following steps: a) The presence of a second heart region electrode lead (4) configured to automatically detect the second heart region or detect electrical signals at the second heart region, wherein the second heart region is part of the ventricular conduction system of the heart (7), and wherein the second heart region electrode lead is implanted or intended to be implanted in the second heart region. b) The second data communication unit transmits a dataset indicating the presence of the second cardiac region electrode lead (4) to the first data communication unit.

11. The apparatus according to claim 10, characterized in that, The first computer-readable program causes the first processor to perform the following steps: a) Receive a dataset indicating the presence of the second cardiac region electrode lead (4) using the first data communication unit; b) In response to receiving the dataset, the second electrode lead configuration is automatically selected.

12. A computer-controlled system for programming an implantable medical device for stimulating a human or animal heart using the apparatus according to any one of claims 1 to 6, wherein the programming apparatus (2) includes a first data communication unit, and wherein the implantable medical device (1) includes a second processor, a second storage unit, a second data communication unit, a stimulation unit, and a detection unit, the stimulation unit being configured to stimulate a cardiac region of a human or animal heart (7), the detection unit being configured to detect an electrical signal at a cardiac region of the same heart (7), wherein the stimulation unit and the detection unit include electrode leads, the system comprising: a) an apparatus for generating a dataset using a programming device (2), the dataset including applicable sensing parameters and / or stimulation parameters for an electrode lead configuration selected on the programming device (2); b) A device for transmitting the dataset to the implantable medical device (1) using the first data communication unit; c) A means for receiving the dataset using a second data communication unit; d) An apparatus for setting the sensing parameters of the detection unit and / or the stimulation parameters of the stimulation unit by using the received dataset.

13. A computer program product including computer-readable code, which, when executed on a processor, causes the processor to perform the following steps: a) Allows selection of at least two electrode lead configurations for an implantable medical device (1) used to stimulate the heart (7) of a human or animal, wherein the at least two electrode lead configurations include: i) A first electrode lead configuration, wherein each electrode lead of the implantable medical device is connected to an electrode lead port of the implantable medical device (1), the electrode lead port being configured to receive an electrode lead for stimulating or detecting an electrical signal at a first cardiac region, wherein the first cardiac region is at least one selected from the atrium, left ventricle, and right ventricle, wherein each electrode lead is implanted or intended to be implanted in a cardiac region corresponding to the first cardiac region to which the electrode lead port to which the electrode lead is connected, and ii) A second electrode lead configuration wherein at least one electrode lead (4) of the implantable medical device (1) is connected to an electrode lead port (3) of the implantable medical device (1), the electrode lead port (3) being configured to receive the electrode lead (4) for stimulating or detecting an electrical signal at the second cardiac region, wherein the second cardiac region is part of the ventricular conduction system of the heart (7), wherein at least one electrode lead (4) is implanted or intended to be implanted in the second cardiac region, wherein the second cardiac region is at least one selected from the His bundle (6) and the left bundle branch. b) When the second electrode lead configuration is selected, a notification signal is generated and released; c) Stimulation of the human or animal heart via the implantable medical device; and When the first electrode lead configuration is selected, the processor does not generate a notification signal.

Citation Information

Patent Citations

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    US20120290034A1