The present invention relates to a medical device, in particular an active electronic implant.

US 2019/0021597 A1 discloses a physiologic monitoring system comprising a central hub in communication with a management portal for communicating physiologic measurements taken from a plurality of peripheral devices on a patient. At least one non-invasive peripheral device may measure physiologic data from a patient and be in communication with said central hub. A system including an invasive peripheral device may be associated with said patient and be in communication with said central hub. The central hub may be scalable to collect and communicate measurements from the non-invasive peripheral device and the invasive peripheral device. The at least one non-invasive peripheral device may include a blood pressure cuff, an oxygen sensor, a weight scale, and an ECG monitor. The invasive peripheral device may include a wireless sensor reader that may be adapted to measure physiologic data from a sensor implant placed within the cardiovascular system of said patient.

With regard to the integration of active implants and implant systems or comparable medical devices into 5G-based networks and subsequent network generations, whereby at least one of the implant or device functions is indirectly or directly influenced, controlled and/or evaluated via the 5G network in real time or near real time, there is regularly the challenge of a restricted device function due to temporary interruption of the network connection, which can lead to an unacceptable patient risk. The 5G network is to be understood as a network according to the fifth generation (5G) mobile communications standard. If other networks with a comparable or higher performance are available, these can also be used for the present invention. Based on this, the object of the present invention is to create a medical device which, in the event of an interruption in the network connection, allows the device to function safely and appropriately for clinical use.

This object is solved by a medical device having the features of claim 1. Advantageous embodiments of the invention are described below.

According to claim 1, a medical device is disclosed comprising at least one function for evaluation of signals and/or for therapy delivery, at least one of said functions requiring timely regulation or control or evaluation for correct function, said medical device further comprising an interface to a network (in particular 5G network or comparable or higher level network), said interface being configured to directly or indirectly communicate with said network (e.g. 5G network) on demand, and via the network communication, e.g., 5G network communication, at least one of the functions can be directly or indirectly influenced, and wherein the medical device comprises a basic supply unit corresponding to the at least one function, which is configured to perform minimal functional requirements of the medical device in case the network connection, e.g., the 5G network connection, is interrupted during the intended use of the medical device.

Furthermore, according to claim 13, a computer-implemented method for operating a medical device is provided.

The method comprises performing at least one function selected from the group of evaluation of signals and therapy delivery.

Furthermore, the method comprises communicating directly or indirectly with the network by means of an interface to a network, in particular a 5G network, wherein the medical device is further directly or indirectly influences the at least one function via the network communication. The method in addition comprises providing a basic function of the medical device by means of a basic supply unit if the network communication is interrupted during intended use of the medical device.

Moreover, the invention provides a computer program comprising program code for performing the method when the computer program is executed on a computer and a computer-readable data carrier with program code of a computer program for performing the method when the computer program is executed on a computer.

The invention thus solves the object of ensuring that medical devices, in particular active electronic medical devices, in particular active implants, which comprise real-time influence by a network connection, are in a sufficiently safe operating mode even in the event of a temporary unavailability of the network.

According to an embodiment of the invention, it is provided that the network, in particular 5G network, has at least a bandwidth of greater than 100 Mbit/sec.

Furthermore, according to an embodiment of the invention, it is provided that the network, in particular 5G network, has at least a typical latency of less than 10 ms.

Furthermore, according to an embodiment of the invention, it is provided that the medical device is an active electronic implant for permanent implantation.

Further, according to an embodiment of the invention, it is provided that the medical device is an active electronic implant for temporary implantation.

Further, according to an embodiment of the invention, it is provided that the medical device is a battery-powered electronic device for temporary or permanent attachment to the body.

Further, the medical device may be one of the following devices:

- a pacemaker;

- a wireless pacemaker; - an implantable defibrillator, transvenous or non-transvenous;

- a neurostimulator, any type;

- a cardiac rhythm monitor;

- an implantable sensor for physiological parameters;

- an implantable communication system, e.g., as a relay station for communication with one or more other implants;

- an implant for monitoring medical prostheses;

- an implant for monitoring patient activity or compliance; and

- an implant for monitoring the patient's medication intake.

Furthermore, according to an embodiment of the invention, said interface of the medical device is formed by a first communication interface used for communication between the medical device and a further communication device, and by the further communication device connected to the network, in particular 5G network, via a second communication interface.

Furthermore, according to an embodiment of the invention, it is provided that the interface of the medical device is directly connected or connectable to the network, in particular the 5G network.

Furthermore, according to an embodiment of the invention, it is provided that the medical device comprises a detection unit for signaling network interruptions, which activates the basic supply unit.

Furthermore, according to an embodiment of the invention, it is provided that the medical device comprises a connection quality analysis unit that can predict a probable connection interruption and thus activates or pre-initializes the basic supply unit in advance.

For a more complete understanding of the present invention and advantages thereof, reference is now made to the following description taken in conjunction with the accompanying drawings. The invention is explained in more detail below using exemplary embodiments, which are specified in the schematic figures of the drawings, in which: Fig. 1 shows a schematic representation of a medical device controllable via a 5G network according to an embodiment of the invention; Fig. 2 shows a schematic representation of a basic supply unit for ensuring a basic function of the medical device in case of a network failure according to the embodiment of the invention; and

Fig. 3 shows a flowchart of a computer-implemented method for operating a medical device failure according to the embodiment of the invention.

5G network technology is characterized by a significantly higher data rate and, above all, significantly lower latency (~1 ms). Likewise, the spatial availability of this network technology is expected to improve significantly compared to the current network coverage In addition to established applications for remote data transmission, 5G technology will support real-time applications for the first time, such as autonomous driving.

Here, the invention particularly exploits the fact of a very short latency of this network technology to be able to realize real-time control of medical devices and, in particular, electronic implants with significantly more complex algorithms and principles.

Fig. 1 shows a 5G network-controlled medical device 110 in the form of an electronic implant, hereinafter also referred to as implant 110. Said implant 110 first transmits to a relay station 120 sensor data recorded by the implant 110. The relay station 120 may be formed as a device (owned) by the patient, for example a cell phone or smart phone. This first transmission link is required for energy reasons, as the power supply and antenna arrangement, i.e. body attenuation, of this implant 110 are not designed for direct communication with a 5G network. The sensor data is then transmitted to a 5G network via base station 130 and/or a 5G satellite 140 to a cloud-based real-time evaluation system 150, where it is evaluated and control signals derived therefrom are transmitted back to the implant 110 in real time via the aforementioned communication system, so that an implant function, such as therapy delivery or therapy adjustment, can be performed directly here. The difference between this and automated remote programming of an implant is that the influence on the control function occurs in near real time, and thus essential implant algorithms for implant control can be relocated to the cloud-based evaluation system 150. In Fig. 2, a temporary interruption of the 5G network connection is shown, here for example between implant 110 and relay station 120. In this situation, real-time influence of the implant function cannot be maintained. In this case, the implant will detect the broken connection and activate a basic supply unit, which is configured in such a way that it secures the basic function of the implant. For example, in the example of an implantable defibrillator, this may be the activation of a simplified detection function for ventricular fibrillation that triggers a defibrillation function when a maximum rate is exceeded, but forgoes the therapy decisions for lower rates (VT/SVT discrimination) supported by the 5G network.

Another specific example of such an application (not shown) is disclosed as a non- transvenous defibrillator. In such a system, the challenge is to have to make a defibrillation therapy decision on a signal very similar to the surface ECG. These signals are influenced by many factors, such as externally coupled disturbances, muscle potentials, changes in patient position, motion artifacts, etc., so that current systems have limited sensitivity and specificity with respect to defibrillation therapy.

If such a defibrillator is implemented according to the invention, the ECG signals are sent to the cloud-based evaluation system 150 before a therapy decision is made. If there is a need for therapy, these signals are evaluated using considerably more complex algorithms, and within a very short time the implant's therapy decision is confirmed or revoked. Again, in the event of a disruption of the 5G network, a basic function of the defibrillator can be provided with the basic supply unit.

The invention enables completely new, more complex possibilities for the control and evaluation of medical devices, in particular active implants due to the network connection according to the invention. By means of the basic supply unit, the basic function of the respective medical device can be ensured with advantage. Fig. 3 shows a flowchart of a computer-implemented method for operating a medical device failure according to the embodiment of the invention.

The method comprises performing SI at least one function selected from the group of evaluation of signals and therapy delivery.

Furthermore, the method comprises communicating S2 directly or indirectly with the network by means of an interface to a network, in particular a 5G network, wherein the medical device 110 is further directly or indirectly influences the at least one function via the network communication.

The method in addition comprises providing S3 a basic function of the medical device 110 by means of a basic supply unit if the network communication is interrupted during intended use of the medical device 110.

Reference Signs

110 medical device

120 relay station 130 base station

140 5G satellite 150 cloud-based evaluation system S1-S3 method steps