Patent Application
20220387804
The present invention relates to an implantable medical device for stimulating a human or animal heart according to the preamble of claim 1, to an arrangement comprising such implantable medical device according to the preamble of claim 9, and to a method for programming such an implantable medical device according to the preamble of claim 15.
Implantable medical devices for stimulating a human or animal heart, such as pacemakers, have been known for a long time. They can perform different functions. Different stimulation programs can be carried out by an appropriate pacemaker to restore the treated heart to a normal state. It is also known to use conventional pacemakers for stimulating the His bundle, i.e., for His bundle pacing (HBP).
The His bundle is a bundle of specific heart muscle cells that is part of the cardiac conduction system. The His bundle is located distally of the atrioventricular node towards the apex of the heart. The His bundle forms part of the ventricular conduction system.
In case of His bundle pacing, a detecting (sensing) and stimulation electrode is not implanted into apex of the ventricle of the human or animal heart to be treated, but rather at or near to the His bundle of the heart. Such use of a His bundle electrode enables a particularly physiologic stimulation of the human or animal heart.
In many cases, conventional pacemakers are used for His bundle pacing. In such a case, the port to which the His bundle electrode is connected is provided with specific stimulation/sensing parameters in order to achieve an appropriate sensing of electric signals at the His bundle and to allow a sufficient and more physiologic stimulation of the His bundle in case His bundle pacing is applied. Thus, there are special requirements for the His channel of an implantable medical device.
Furthermore, there exists a plurality of different implantable medical devices for stimulating a human or animal heart for a plurality of different clinical indications. Each clinical indication requires a specific functionality for His bundle pacing. An implementation of a dedicated His bundle pacing system depicts a very sophisticated task not only from a technical point of view but also regarding usability and safety. An implementation of all desirable HBP configurations would require a large number of additional variants of conventional implantable medical devices and their software applications.
Conventional implantable medical devices do not comprise an electrode lead port for receiving a His bundle electrode. Therefore, depending on the user (physician), a His bundle electrode may be connected to any of the available electrode lead ports of such a conventional implantable medical device. This manifests in confusion, false interpretation of the settings and measured data and wrong programming by the attending physician during the implantation procedure and follow-up examinations. This may cause dangerous, life threatening conditions of a patient.
The present disclosure is directed toward overcoming one or more of the above-mentioned problems, though not necessarily limited to embodiments that do.
It is an object of the present invention to provide an implantable medical device that is intended to be used for His bundle pacing and that allows a safer operation than prior art devices.
At least this object is achieved with an implantable medical device for stimulating a human or animal heart having the features of claim 1. Such an implantable medical device comprises a first processor, a first memory unit, a stimulation unit, a detection unit, and a first electrode lead port. The stimulation unit serves for stimulating a cardiac region of a human or animal heart. The detection unit serves for detecting an electrical signal at the same or a different cardiac region of the same heart. The first electrode lead port serves for receiving an electrode lead.
According to an aspect of the presently claimed invention, the first electrode lead port comprises a first marking element and a second marking element. In this context, the first marking element indicates a first possible kind of electrode lead that can be received by the first electrode lead port. Furthermore, the first marking element indicates for which kind of electrode lead the first electrode lead port is designed to be configured. Thus, the first marking element does not only denote the general suitability of the first electrode lead port to receive a specific kind of electrode lead, but also the general ability of this electrode lead port to be configured such to operate a connected electrode lead in a sensible way.
The first possible kind of electrode lead is a His bundle electrode lead. Thus, the first marking element indicates which electrode lead port is specifically configured to receive a His bundle electrode lead and can furthermore be controlled in such a way that it detects electric signals at the His bundle of the human heart with a connected His bundle electrode lead and/or to stimulate the His bundle of the human heart with a connected His bundle electrode lead. Thus, the first marking element indicates that the first electrode lead port of the implantable medical device is specifically adapted for His bundle pacing.
The second marking element indicates a second possible kind of electrode lead that can be received by the first electrode lead port. Furthermore, the second marking element indicates that the first electrode lead port is designed to be configured for the operation of such a second possible kind of electrode lead. In this context, 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.
Consequently, the presence of the first marking element and the second marking element indicates that the first electrode lead port is intended to receive either a His bundle electrode lead or one of an atrial electrode lead, a right ventricular electrode lead, and a left ventricular electrode lead. Furthermore, the first marking element and the second marking element indicate that the first electrode lead port can be specifically configured such to operate either a His bundle electrode lead or an electrode lead of the second possible kind of electrode lead in a way that allows proper functioning of such electrode lead.
Consequently, a user, like a physician, is no longer left in doubt which electrode lead port of the implantable medical device is configured to receive a His bundle electrode or, if no His bundle pacing is to be applied, an electrode of another (specifically defined) kind of electrode lead. Therefore, no space is left for confusion, false interpretation of settings or measured data nor for wrong programming of the implantable medical device. This, in turn, significantly reduces the risk of dangerous, life-threatening conditions of a patient to whom the implantable medical device is implanted for applying cardiac stimulation.
The implantable medical device is likewise appropriate for conventional cardiac stimulation and for His bundle pacing. Due to the first and second marking elements, its use is facilitated for both use cases. Therefore, a proper allocation of the target device port for a His bundle electrode upon implantation is made possible for all kinds of clinical applications. Furthermore, during clinical follow-ups, the measured signals, pacing behavior and His bundle specific settings applied to the His bundle channel of the implantable medical device can unmistakably assigned and interpreted.
Due to the presence of the first marking element and the second element, as well as the specific configurations of the first electrode lead port bearing the first marking element and the second marking element, the number of implantable medical devices being able for His bundle pacing and the number of software variants can be significantly reduced in comparison to the present situation, wherein all desirable His bundle pacing use cases are still covered and can be applied by the implantable medical device. Since the first electrode lead port bears the first marking element and the second marking element, it is adapted to receive either a His bundle electrode lead or a conventional electrode lead (namely a second possible kind of electrode lead). Thus, a selection between conventional cardiac stimulation and His bundle pacing is made possible.
In an embodiment, the configuration of the first electrode lead port for the operation of the first possible kind of electrode lead, i.e., the His bundle electrode lead, comprises at least one of i) providing dedicated sensing and/or pacing parameters for His bundle pacing that are different to those used in a conventional pacing configuration, ii) ensuring specialized
His bundle pacing timing settings for treating bradycardia, iii) providing a well-matched device feature set for His bundle pacing, iv) ensuring a proper and safe patient support in all possible device operating modes and conditions (such as permanent pacing mode (standard condition of the device) standard/normal mode, magnetic resonance imaging (MM) mode, backup mode and any of the temporary test pacing modes).
In an embodiment, the implantable medical device is an implantable pulse generator (IPG), an implantable cardioverter-defibrillator (ICD), or a device for cardiac resynchronization therapy (CRT).
In an embodiment, the first memory unit comprises a first computer-readable program that causes the first processor to perform the steps explained in the following when executed on the first processor. First, a dataset is retrieved or received. The dataset indicates 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. Retrieving such a dataset can be done by restoring it from the second memory unit. Receiving such a dataset can be done by using a (wireless) communication unit. The dataset may be received from a programming device. Furthermore, the first electrode lead port is operated with stimulation and/or sensing parameters that are 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. Alternatively, the first electrode lead port is operated 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. Consequently, the retrieved or received dataset determines the kind of operation (His bundle pacing or conventional pacing) of the implantable medical device.
In an embodiment, the kind of electrode lead connected to the first electrode lead port is automatically detected by the implantable medical device. In such a case, no dataset indicating the kind of connected electrode lead is necessary. Then, the operation of the implantable medical device can be controlled on the basis of the previously determined kind of electrode lead connected to the first electrode lead port, as explained in the preceding paragraph.
In an embodiment, the first electrode lead port comprises a third marking element. In this context, the third marking element indicates a third possible kind of electrode lead that can be received by the first electrode lead port and for operation of which possible kind of electrode lead the first electrode lead port is specifically adapted. 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. Thus, the first electrode lead port can be used to connect an electrode lead out of a plurality of different kinds of electrode leads.
In an embodiment, the second possible kind of electrode lead is an atrial electrode lead and the third possible kind of electrode lead is a right ventricular electrode lead. In this embodiment, the first electrode lead port is specifically configured to receive either an atrial electrode lead or a right ventricular electrode lead or a His bundle electrode lead. Furthermore, the first electrode lead port is specifically adapted to operate either an atrial electrode lead or a right ventricular electrode lead or a His bundle electrode lead in this embodiment.
In an embodiment, the second possible kind of electrode lead is a right ventricular electrode lead. In case of only two marking elements, the first electrode lead port is specifically configured, in this embodiment, to receive either a right ventricular electrode lead or a His bundle electrode lead.
In an embodiment, the implantable medical device additionally comprises a second electrode lead port. In this context, the second electrode lead port comprises a fourth marking element. The fourth marking element indicates a fourth possible kind of electrode lead that can be received by the second electrode lead port. Furthermore, the fourth marking element indicates that the second electrode lead port is specifically adapted for operation of an electrode lead of a fourth possible kind of electrode lead. The fourth possible kind of electrode lead is an atrial electrode lead. A combination of this embodiment and the precedingly explained embodiment results in a dual chamber implantable medical device comprising a first electrode lead port configured to receive and to operate a right ventricular electrode or a His bundle electrode and a second electrode lead port configured to receive and to operate a right atrial electrode.
In an embodiment, the implantable medical device additionally comprises a third electrode lead port. The third electrode lead port comprises a fifth marking element. In this context, 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 fifth possible kind of electrode lead the third electrode lead port is specifically adapted. The fifth possible kind of electrode lead is a left ventricular electrode lead. A combination of this embodiment and the precedingly explained two embodiments results in a triple chamber implantable medical device comprising three electrode lead ports. The first electrode lead port is configured to receive and to operate a right ventricular electrode or a His bundle electrode. The second electrode lead port is specifically adapted to receive and to operate a right atrial electrode. The third electrode lead port is adapted to receive and to operate a left ventricular electrode.
In an embodiment, the third electrode lead port does not only comprise the fifth marking element, but also a sixth marking element. In this context, the sixth marking element indicates a sixth possible kind of electrode lead that can be received by the third electrode lead port. Furthermore, the sixth marking element indicates that the third electrode lead port is specifically adapted for an operation of an electrode lead of the sixth possible kind of electrode lead. In this context, the sixth possible kind of electrode lead is a right ventricular backup electrode lead (hereinafter referred to as RV-backup). Such a RV-backup is typically implanted in an apical region of the right ventricle of the heart to be stimulated. It is used if a cardiac stimulation with the His bundle electrode does not function as intended, i.e., if His bundle pacing with the His bundle electrode is not successful. Then, the RV-backup is used for stimulating the right ventricle of the heart to be stimulated. The RV-backup generally functions like a conventional right ventricular electrode lead and, thus, requires for proper operation stimulation parameters similar or identical to stimulation parameters of the right ventricular electrode lead.
In an aspect, the present invention relates to an arrangement comprising an implantable medical device according to the preceding explanations and a programming device for programming this implantable medical device.
In an embodiment, the programming device comprises a second processor and a second memory unit. Furthermore, the second memory unit comprises a second computer-readable program that causes the second processor to perform the steps explained in the following when executed on the second processor.
First, a selection of one of at least two electrode lead configurations of the implantable medical device is made possible. In this context, 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. Furthermore, the at least two electrode lead configurations comprise a second electrode lead configuration in which a His bundle electrode lead is connected to the first electrode lead port of the implantable medical device.
If the first electrode lead configuration is selected, at least one sensing and/or stimulation parameter of the first electrode lead port is then set to a value being appropriate for conventional cardiac pacing. If, on the other hand, the second electrode lead configuration is selected, at least one sensing and/or stimulation parameter of the first electrode lead port is set to a value appropriate for His bundle pacing. In this context, this value appropriate for His bundle pacing differs from the value of the same sensing and/or stimulation parameter being appropriate for conventional cardiac pacing. Thus, the selection between the first electrode lead configuration and the second electrode lead configuration determines the kind of operation of the first electrode lead port and an associated electrode.
In an embodiment, the second computer-readable program causes the second processor to perform the steps explained in the following when executed on the second processor.
First, a selection of one of at least two electrode lead configurations of the implantable medical device is made possible. The at least two electrode lead configurations comprise a first electrode lead configuration and a second electrode lead configuration. In the first electrode lead configuration, an electrode lead of the first possible kind of electrode lead (i.e., a His bundle electrode lead) is connected to the implantable medical device. In the second electrode lead configuration, an electrode lead of the second possible kind of electrode lead is connected to the first electrode lead port (i.e., no His bundle electrode lead is connected to the first electrode lead port, but rather one of an atrial electrode lead, a right ventricular electrode lead, and a left ventricular electrode lead).
Afterwards, a dataset is transmitted to the implantable medical device. The dataset indicates whether the first electrode lead configuration or the second electrode lead configuration has been selected. Afterwards, the implantable medical device uses, in an embodiment, this dataset for specifically adapting sensing and/or stimulation parameters of the first electrode port so as to be able to properly operate a His bundle electrode lead or an electrode lead other than a His bundle electrode lead. As an alternative, or in addition, the dataset could be specifically adapted to ensure specialized His bundle pacing timing settings for treating bradycardia, to provide a well-matched device feature set for His bundle pacing, and/or to ensure a proper and safe patient support in all possible device operating modes and conditions.
In an embodiment, the second electrode lead configuration comprises the setting explained in the following. On the one hand, the implantable medical device comprises 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 appropriate for configuring a single chamber implantable medical device for His bundle pacing.
In an embodiment, the second electrode lead configuration comprises the setting explained the following. On the one hand, the implantable medical device comprises exactly two electrode ports, namely, the 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 appropriate for a dual chamber implantable medical device specifically adapted for His bundle pacing.
In an embodiment, the second electrode lead configuration comprises the setting explained the following. On the one hand, the implantable medical device comprises exactly three electrode lead ports, namely, the first electrode lead port, the second electrode lead port, and a third electrode lead port. On the other hand, three different concrete electrode configurations are possible in this embodiment.
In the first configuration, a His bundle electrode is connected to the first electrode lead port, wherein no electrode is connected to the second electrode lead port. Furthermore, a right ventricular electrode lead is connected to the third electrode lead port. This configuration is particularly appropriate for a triple chamber implantable medical device specifically adapted for His bundle pacing, wherein the right ventricular electrode serves as RV-backup. Such a configuration can be used in case of atrioventricular node ablation scenarios in which no proper atrial sensing/pacing is any longer possible.
In the second configuration, a His bundle electrode 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. Such a setting is appropriate for physiologic His bundle pacing with a right ventricular electrode as RV-backup.
In a third configuration, 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. Such a configuration is particularly appropriate for cardiac resynchronization therapy.
In an aspect, the present invention relates to a method for programming an implantable medical device according to the preceding explanations with a programming device. In this context, the implantable medical device comprises a first data communication unit, and the programming device comprises a second data communication unit. The method comprises the steps explained in the following.
First, one of at least two electrode lead configurations of the implantable medical device is selected with the programming device. The at least two electrode lead configurations comprise a first electrode lead configuration and a second electrode lead configuration. In the first electrode lead configuration, no His bundle electrode lead is connected to the implantable medical device. In an embodiment, an electrode lead of the second kind of electrode lead is connected to the first electrode lead port in the first electrode lead configuration. In the second electrode lead configuration, a His bundle electrode lead is connected to a first electrode lead port of the implantable medical device.
After having made this selection, a dataset is generated with the programming device. This dataset comprises an appropriate sensing parameter and/or stimulation parameter (or a set of appropriate sensing parameters and/or stimulation parameters) for the electrode lead configuration selected on the programming device.
Afterwards, this dataset is transmitted with the second data communication unit from the programming device to the implantable medical device. At the implantable medical device, the dataset is received with the first data communication unit.
Finally, a sensing parameter of the detection unit and/or a stimulation parameter of the stimulation unit is set by using the received dataset.
In an embodiment, the first and second data communication units serve for transferring data from the programming device to the implantable medical device or vice versa in a wireless manner. All standard data transmission protocols or specifications are appropriate for such a wireless data communication. Examples of standard data transmission protocols or specifications are the Medical Device Radiocommunications Service (MICS), the Bluetooth Low Energy (BLE) protocol and the Zigbee specification.
In an embodiment, the method is carried out such that at least one sensing and/or stimulation parameter of the first electrode lead port is set to a value appropriate for conventional cardiac pacing if the first electrode lead configuration is selected. Furthermore, at least one sensing and/or stimulation parameter of the first electrode lead port is set to a value appropriate for His bundle pacing in case that the second electrode lead configuration is selected. In this context, the value of the at least one sensing and/or stimulation parameter appropriate for His bundle pacing differs from the value of the same sensing and/or stimulation parameter appropriate for conventional cardiac pacing. In doing so, the first electrode lead port is specifically configured to an operational state allowing proper operation of different kinds of electrodes (namely, on the one hand, a His bundle electrode and, on the other hand, a right atrial electrode, a right ventricular electrode, or a left ventricular electrode) depending on the type of electrode connected to the first electrode lead port.
All embodiments of the implantable medical device can be combined in any desired way and can be transferred either individually or in any arbitrary combination to the described arrangement, and to the described method. Furthermore, all embodiments described with respect to the arrangement can be combined in any desired way and can be transferred either individually or in any arbitrary combination to the described implantable medical device and to the described method. Likewise, all embodiments of the described method can be combined in any desired way and can be transferred either individually or in any arbitrary combination to the implantable medical device and to the arrangement.
Additional features, aspects, objects, advantages, and possible applications of the present disclosure will become apparent from a study of the exemplary embodiments and examples described below, in combination with the Figures and the appended claims.
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:
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.
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.
In contrast to the embodiment depicted in
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.
The first electrode lead port 2 is configured to receive a right ventricular electrode or a His bundle electrode. In the embodiment of
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.
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.
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.
All electrode lead configurations depicted in
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.
| Number | Date | Country | Kind |
|---|---|---|---|
| 19205046.6 | Oct 2019 | EP | regional |
This application is the United States National Phase under 35 U.S.C. § 371 of PCT International Patent Application No. PCT/EP2020/079745, filed on Oct. 22, 2020, which claims the benefit of European Patent Application No. 19205046.6, filed on Oct. 24, 2019, the disclosures of which are hereby incorporated by reference herein in their entireties.
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/EP2020/079745 | 10/22/2020 | WO |
