Implantable Medical Device Having a His Bundle Electrode Lead Port

Abstract

An implantable medical device for stimulating a human/animal heart, comprising a first electrode lead port for receiving an electrode lead. The first electrode lead port comprises a first marking element and a second marking element, wherein the first marking element indicates a first kind of electrode lead that can be received by the first electrode lead port and for an operation of which the first electrode lead port is designed to be configured, wherein the first kind of electrode lead is a His bundle electrode lead , wherein the second marking element indicates a second kind of electrode lead that can be received by the first electrode lead port and for an operation of which the first electrode lead port is designed to be configured. The second kind of electrode lead includes one of an atrial electrode lead, a right ventricular electrode lead, and a left ventricular electrode lead.

Claims

1. Implantable medical device for stimulating a human or animal heart, comprising a first processor, a first memory unit, a stimulation unit configured to stimulate a cardiac region of a human or animal heart, a detection unit configured to detect an electrical signal at the cardiac region of the same heart, and a first electrode lead port for receiving an electrode lead, wherein the first electrode lead port comprises a first marking element and a second marking element, wherein the first marking element indicates a first possible kind of electrode lead that can be received by the first electrode lead port and for an operation of which the first electrode lead port is designed to be configured, wherein the first possible kind of electrode lead is a His bundle electrode lead, wherein the second marking element indicates a second possible kind of electrode lead that can be received by the first electrode lead port and for an operation of which the first electrode lead port is designed to be configured, wherein the second possible kind of electrode lead is chosen from the group consisting of an atrial electrode lead, a right ventricular electrode lead, and a left ventricular electrode lead.

2. Implantable medical device according to claim 1, wherein the first memory unit comprises a first computer-readable program that causes the first processor to perform the following steps when executed on the first processor: a) retrieving or receiving a dataset indicating whether an electrode lead of the first possible kind of electrode lead or an electrode lead of the second possible kind of electrode lead is connected to the first electrode lead port; b) operating the first electrode lead port with stimulation and/or sensing parameters being specifically adapted for His bundle pacing if an electrode lead of the first possible kind of electrode lead is connected to the first electrode lead port or operating the first electrode lead port with stimulation and/or sensing parameters being appropriate for conventional cardiac pacing if an electrode lead of the second possible kind of electrode lead is connected to the first electrode lead port.

3. Implantable medical device according to claim 1, wherein the first electrode lead port comprises a third marking element, wherein the third marking element indicates a third possible kind of electrode lead that can be received by the first electrode lead port and for an operation of which the first electrode lead port is designed to be configured, wherein the third possible kind of electrode lead is chosen from the group consisting of an atrial electrode lead, a right ventricular electrode lead, and a left ventricular electrode lead.

4. Implantable medical device according to claim 3, wherein the second possible kind of electrode lead is an atrial electrode lead and in that the third possible kind of electrode lead is a right ventricular electrode lead.

5. Implantable medical device according to claim 1, wherein the second possible kind of electrode lead is a right ventricular electrode lead.

6. Implantable medical device according to claim 5, wherein the implantable medical device comprises a second electrode lead port, wherein the second electrode lead port comprises a fourth marking element, wherein the fourth marking element indicates a fourth possible kind of electrode lead that can be received by the second electrode lead port and for an operation of which the second electrode lead port is designed to be configured, wherein the fourth possible kind of electrode lead is an atrial electrode lead.

7. Implantable medical device according to claim 5, wherein the implantable medical device comprises a third electrode lead port, wherein the third electrode lead port comprises a fifth marking element, wherein the fifth marking element indicates a fifth possible kind of electrode lead that can be received by the third electrode lead port and for an operation of which the third electrode lead port is designed to be configured, wherein the fifth possible kind of electrode lead is a left ventricular electrode lead.

8. Implantable medical device according to claim 7, wherein the third electrode lead port also comprises a sixth marking element, wherein the sixth marking element indicates a sixth possible kind of electrode lead that can be received by the third electrode lead port and for an operation of which the third electrode lead port is designed to be configured, wherein the sixth possible kind of electrode lead is a right ventricular backup electrode lead.

9. Arrangement comprising an implantable medical device according to claim 1 and a programming device for programming the implantable medical device.

10. Arrangement according to claim 9, wherein the programming device comprises a second processor and a second memory unit, wherein the second memory unit comprises a second computer-readable program that causes the second processor to perform the following steps when executed on the second processor: a) allowing to select one of at least two electrode lead configurations of the implantable medical device, wherein the at least two electrode lead configurations comprise a first electrode lead configuration in which no His bundle electrode lead is connected to the implantable medical device and a second electrode lead configuration in which a His bundle electrode lead (8) is connected to a first electrode lead port of the implantable medical device; and b) if the first electrode lead configuration is selected, setting at least one sensing and/or stimulation parameter of the first electrode lead port to a value appropriate for conventional cardiac pacing; if the second electrode lead configuration is selected, setting at least one sensing and/or stimulation parameter of the first electrode lead port to a value appropriate for His bundle pacing and differing from a value of the same sensing and/or stimulation parameter appropriate for conventional cardiac pacing.

11. Arrangement according to claim 9, wherein the programming device comprises a second processor and a second memory unit, wherein the second memory unit comprises a second computer-readable program that causes the second processor to perform the following steps when executed on the second processor: a) allowing to select one of at least two electrode lead configurations of the implantable medical device, wherein the at least two electrode lead configurations comprise a first electrode lead configuration in which no His bundle electrode lead is connected to the implantable medical device and a second electrode configuration in which a His bundle electrode lead is connected to a first electrode port of the implantable medical device; and b) transmitting a dataset to the implantable medical device, the dataset indicating whether the first electrode lead configuration or the second electrode lead configuration is selected.

12. Arrangement according to claim 9, wherein the second electrode lead configuration comprises the following setting: a) the implantable medical device comprises a single electrode lead port, namely the first electrode lead port; and b) a His bundle electrode lead is connected to the first electrode lead port.

13. Arrangement according to claim 9, wherein the second electrode lead configuration comprises the following setting: a) the implantable medical device comprises exactly two electrode lead ports, namely the first electrode lead port and a second electrode lead port; and b) a His bundle electrode lead is connected to the first electrode lead port and a right atrial electrode lead is connected to the second electrode lead port.

14. Arrangement according to claim 9, wherein the second electrode lead configuration comprises one of the following settings: a) the implantable medical device comprises exactly three electrode lead ports, namely the first electrode lead port, a second electrode lead port, and a third electrode lead port; and b) i) a His bundle electrode lead is connected to the first electrode lead port, no electrode lead is connected to the second electrode lead port, and a right ventricular electrode lead is connected to the third electrode lead port; or ii) a His bundle electrode lead is connected to the first electrode lead port, a right atrial electrode lead is connected to the second electrode lead port, and a right ventricular electrode lead is connected to the third electrode lead port; or iii) a His bundle electrode lead is connected to the first electrode lead port, a right atrial electrode lead is connected to the second electrode lead port, and a left ventricular electrode lead is connected to the third electrode lead port.

15. Method for programming an implantable medical device according to claim 1 with a programming device, wherein the implantable medical device comprises a first data communication unit, wherein the programming device comprises a second data communication unit, the method comprising the following steps: a) selecting, with the programming device, one of at least two electrode lead configurations of the implantable medical device, wherein the at least two electrode lead configurations comprise a first electrode lead configuration in which no His bundle electrode lead is connected to the implantable medical device and a second electrode configuration in which a His bundle electrode lead is connected to a first electrode port of the implantable medical device; b) generating, with the programming device, a dataset for an electrode lead configuration selected on the programming device comprising one or more of, i) an appropriate sensing parameter and/or stimulation parameter, ii) appropriate pacing time settings for treating brachycardia, iii) parameters to provide a well-matched device feature set, and iv) parameters to ensure a proper and safe patient support in all possible device operating modes and conditions; c) transmitting, with the second data communication unit, the dataset to the implantable medical device; d) receiving, with the first data communication unit, the dataset; and e) setting a sensing parameter of the detection unit and/or a stimulation parameter of the stimulation unit by using the received dataset.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0052] Further details of aspects of the present invention will be described in the following making reference to exemplary embodiments and accompanying Figures. In the Figures:

[0053] FIG. 1A shows a first electrode lead configuration of a single chamber pacemaker;

[0054] FIG. 1B shows a second electrode lead configuration of the single chamber pacemaker of FIG. 1A;

[0055] FIG. 1C shows a third electrode lead configuration of the single chamber pacemaker of FIG. 1A;

[0056] FIG. 2A shows a first electrode lead configuration of a dual chamber pacemaker;

[0057] FIG. 2B shows a second electrode lead configuration of the dual chamber pacemaker of FIG. 2A;

[0058] FIG. 3A shows a first electrode lead configuration of a first triple chamber pacemaker;

[0059] FIG. 3B shows a second electrode lead configuration of the first triple chamber pacemaker of FIG. 3A;

[0060] FIG. 3C shows a third electrode lead configuration of the first triple chamber pacemaker of FIG. 3A;

[0061] FIG. 3D shows a fourth electrode lead configuration of the first triple chamber pacemaker of FIG. 3A;

[0062] FIG. 4A shows a first electrode lead configuration of a second triple chamber pacemaker; and

[0063] FIG. 4B shows a second electrode lead configuration of the second triple chamber pacemaker of FIG. 4A.

DETAILED DESCRIPTION

[0064] FIG. 1A a shows a first electrode lead configuration of a single chamber pacemaker 1 serving as implantable medical device. This single chamber pacemaker 1 comprises a single electrode lead port 2 serving as first electrode lead port. This electrode lead port 2 comprises a first label “His” being representative for a first marking element, a second label “RV” being representative for a second marking element, and a third label “RA” representing a third marking element. Furthermore, a right atrial electrode 3 is connected to the electrode lead port 2. This right atrial electrode 3 contacts the cardiac tissue in an atrium 4 of a human heart 5 to be stimulated.

[0065] In this first electrode lead configuration, it is possible to sense atrial electric signals in the atrium 4 of the heart 5 with the help of the right atrial electrode 3. Furthermore, it is possible to stimulate the atrium 4 of the human heart 5 with the help of the right atrial electrode 3. For this purpose, stimulation pulses are applied by the pacemaker 1 via the electrode lead port 2 in a conventional way. Thus, the electrode lead port 2 is configured to apply stimulation pulses to the right atrial electrode 3 making use of conventional sensing/stimulation parameters, e.g., according to the established AAI modus.

[0066] A front view onto the electrode lead port 2 is depicted directly below the pacemaker 1. This front view serves for illustrating that a right atrial electrode 3 is connected to the electrode lead port 2 being appropriate for receiving of the right atrial electrode 3 as indicated by the label RA.

[0067] FIG. 1B shows a second electrode lead configuration of the same single chamber pacemaker 1, wherein in this and in all following Figures similar elements are denoted with the same numeral reference.

[0068] In contrast to the embodiment depicted in FIG. 1A, the electrode lead port 2 of the pacemaker 1 is configured to receive a right ventricular electrode 6 that is implanted in an apical region of a right ventricle 7 of the human heart 5. In this electrode lead configuration, the pacemaker 1 can be operated according to the established VVI modus.

[0069] As can be seen from the front view onto the electrode lead port 2, the electrode lead port 2 is configured to receive the right ventricular electrode 6, as indicated by the label RV. Furthermore, the electrode lead port 2 is specifically configured to be operated such to allow proper control and proper sensing/stimulation of the human heart 5 by means of the right ventricular electrode 6.

[0070] FIG. 1C shows a third electrode lead configuration of the single chamber pacemaker 1, wherein a His bundle electrode 8 is connected to of the electrode lead port 2. The His bundle electrode 8 is implanted at the His bundle 9 of the human heart 5 and allows a particularly physiologic stimulation of the human heart 5. The electrode lead port 2 is configured to receive the His bundle electrode 8, as indicated by the label His. Furthermore, this label indicates that the electrode lead port is specifically adapted to operate the His bundle electrode 8 with His bundle specific stimulation/sensing parameters so as to be able to detect electric signals at the His bundle 9 of the human heart 5 and to apply appropriate stimulation pulses for His bundle pacing.

[0071] FIG. 2A shows an electrode lead configuration for a dual chamber pacemaker 10 serving as implantable medical device. This dual chamber pacemaker 10 can particularly well be used for treating bradycardia. The dual chamber pacemaker 10 comprises a first electrode lead port 2 and a second electrode lead port 20. The first electrode lead port 2 is configured to receive either a right ventricular electrode (as indicated by the label “RV”) or a His bundle electrode (as indicated by the label “His”). The second electrode lead port 20 is configured to receive a right atrial electrode, as indicated by the label “RA”. In the electrode lead configuration depicted in FIG. 2A, a right ventricular electrode 6 is connected to the first electrode lead port 2. Furthermore, this right ventricular electrode 6 is implanted in an apical region of the right ventricle 7 of the human heart 5. Furthermore, a right atrial electrode 3 is connected to the second electrode lead port 20 and is implanted near the atrioventricular node in the atrium 4 of the human heart 5.

[0072] FIG. 2B shows another electrode lead configuration of the dual chamber pacemaker 10 of FIG. 2A. Instead of a right ventricular electrode (cf. FIG. 2A), a His bundle electrode 8 is connected to the first electrode lead port 2. This His bundle electrode 8 is implanted at the His bundle 9 of the human heart 5. The second electrode lead port 20 is connected to the right atrial electrode 3 that is implanted in the atrium 4 of the human heart 5. In this configuration the dual chamber pacemaker 10 can be used for treating bradycardia and/or cardiac resynchronization therapy.

[0073] FIG. 3A shows an electrode lead configuration of another pacemaker, namely a triple chamber pacemaker 100 having a first electrode lead port 2, a second electrode lead port 20 and a third electrode lead port 200. A right ventricular electrode 6 is connected to the first electrode lead port 2. A right atrial electrode lead 3 is connected to the second electrode lead port 20. Furthermore, a left ventricular electrode 11 is connected to the third electrode lead port 200. The right ventricular electrode 6 is implanted in an apical region of the right ventricle 7 of the human heart 5. The right atrial electrode 3 is implanted in the atrium 4 of the human heart 5. The left ventricular electrode 11 is implanted on an outside of the left ventricle 12, in particular in the coronary sinus system, of the human heart 5. Such electrode configuration is particularly appropriate for conventional cardiac resynchronization therapy.

[0074] FIG. 3B shows another electrode lead configuration that can be selected and applied for the triple chamber pacemaker 100. Here, only two electrodes are connected to the triple chamber pacemaker 100, namely a His bundle electrode 8 to the first electrode lead port 2 and a right ventricular electrode 6 to the third electrode lead port 200. The third electrode lead port 200 generally serves for receiving a left ventricular electrode (cf. FIG. 3A), as indicated by the label “LV”. Furthermore, it serves for receiving a RV-backup (as indicated by the label “Bckp”) employed in form of the right ventricular electrode 6. The second electrode lead port 20 is left empty and closed up. This electrode lead configuration is particularly appropriate for physiologic His bundle pacing in case of atrioventricular node ablation scenarios.

[0075] FIG. 3C shows another electrode lead configuration that can be selected for the triple chamber pacemaker 100. Here, all three electrode lead ports 2, 20, 200 are occupied by a corresponding electrode. To be more precise, a His bundle electrode 8 is connected to the first electrode lead port 2, a right atrial electrode 3 is connected to the second electrode lead port 20 and a right ventricular electrode lead 6 is connected as RV-backup to the third electrode lead port 200. Such an electrode lead configuration of the triple chamber pacemaker 100 is particularly appropriate for physiologic His bundle pacing with right ventricular backup pacing.

[0076] FIG. 3D shows another electrode lead configuration of the triple chamber pacemaker 100. In is this electrode lead configuration, the His bundle electrode 8 is connected to the first electrode lead port 2. The right atrial electrode 3 is connected to the second electrode lead port 20. Furthermore, a left ventricular electrode 11 is connected to the third electrode lead port 200. Such an electrode lead configuration of the triple chamber pacemaker 100 is particularly appropriate for physiologic His bundle pacing applied for cardiac resynchronization therapy (also called His-Optimized Cardiac Resynchronization Therapy (HOT-CRT)).

[0077] FIG. 4A shows a second triple chamber pacemaker 1000 serving as implantable medical device. This triple chamber pacemaker 1000 comprises also a first electrode lead port 2, a second electrode lead port 20 and a third electrode lead port 200. However, the second electrode lead port 2 and the third electrode lead port 200 bear different labels and are configured for the connection of different electrodes.

[0078] The first electrode lead port 2 is configured to receive a right ventricular electrode or a His bundle electrode. In the embodiment of FIG. 4A, a right ventricular electrode 6 is connected to the first electrode lead port 2.

[0079] The second electrode lead port 20 is configured to receive a left ventricular quadripolar electrode 11. Consequently, such a left ventricular electrode 11 is also connected to the second electrode lead port 20. As explained above, such left ventricular electrode 11 is implanted on an outside of the left ventricle 12 in particular in the coronary sinus system, of the human heart 5 to be stimulated.

[0080] The third electrode lead port 200 is configured to receive and to operate a right atrial electrode. Consequently, a right atrial electrode 3 is connected to the third electrode lead port 200.

[0081] Such an electrode configuration of the triple chamber pacemaker 1000 is particularly appropriate for physiologic His bundle pacing for cardiac resynchronization therapy using a left ventricular quadrupolar electrode.

[0082] All electrode lead configurations depicted in FIGS. 1A to 4B are intended to be selectable in a programming device for programming an implantable medical device. In doing so, the number and/or kind of selectable electrode configurations can be limited to the needs or technical possibilities of the respective cardiac pacemaker. E.g., if a single chamber pacemaker is used, only those electrode configurations for single chamber pacemakers are to be applied or to be selectable. If triple chamber pacemakers are used, only those configurations are to be selectable which comply with a specific configuration of the individual electrode lead port of the pacemaker. Then, a programming of the according pacemaker is made particularly simple.

[0083] It will be apparent to those skilled in the art that numerous modifications and variations of the described examples and embodiments are possible in light of the above teachings of the disclosure. The disclosed examples and embodiments are presented for purposes of illustration only. Other alternate embodiments may include some or all of the features disclosed herein. Therefore, it is the intent to cover all such modifications and alternate embodiments as may come within the true scope of this invention, which is to be given the full breadth thereof. Additionally, the disclosure of a range of values is a disclosure of every numerical value within that range, including the end points.