Patent Description:
If medical devices and in particular active electronic implants are influenced in real time by means of <NUM> network connectivity, a certain amount of additional power is required for this network connectivity, which cannot be guaranteed/accepted on a permanent basis for some product systems, such that this requires appropriate power management for the network connection.

Furthermore, current active medical devices with limited power supply capabilities are regularly unable to connect directly to a cellular network or equivalent. However, as <NUM> network technology is introduced, this need will increase significantly as control and diagnostic concepts for active medical devices experience a shift of algorithms from the medical device to cloud-based computing systems. Document <CIT> discloses the most relevant prior art.

Based on the foregoing, the invention is directed to providing a medical device that is improved with respect to at least one of the above problem areas.

This task is solved by a medical device having the features of claim <NUM>. Further preferred embodiments of the invention are described below. The invention is defined in claims <NUM> and <NUM>. Any embodiment, which is in contradiction to the subject-matter of claims <NUM> or <NUM>, is not part of the invention.

According to claim <NUM>, corresponding to a first aspect of the invention, a medical device is disclosed, in particular with limited power supply, such as an implantable active implant for implantation in human or animal tissue, wherein the medical device comprises at least one function for evaluating signals or comprises at least one function for delivering therapy, and in particular at least one of these functions requires timely regulation or control or evaluation for correct function, and wherein the medical device comprises an interface to a network, preferably to a <NUM> network or to a comparable or higher level network, wherein the interface is directly or indirectly connected to the network, e.g. a <NUM> network on demand and via the network communication, e.g. <NUM> network communication direct or indirect influence can be exerted on at least one of the functions of the medical device, and wherein the medical device comprises a predetection unit that activates a connection to the network only whenever an immediate need for real-time assessment or influence has been detected.

In other words, the invention describes the integration of active implants and implant systems or comparable medical devices into <NUM>-based networks and subsequent network generations, wherein at least one of the implant or device functions is indirectly or directly influenced, controlled and/or evaluated via the <NUM> network in real time or near real time, wherein a pre-criterion must be met prior to activation of the <NUM> real-time influence.

The invention thus solves the problem that active electronic medical devices with limited energy budget, in particular active implants comprising real-time influencing by <NUM> network connectivity, use the available energy budget for <NUM> network communication efficiently, i.e., only when immediately needed.

According to the invention, the predetection unit is influenced with respect to its sensitivity by a remaining energy supply of the medical device.

Furthermore, according to an embodiment of the invention, it is provided that the network, in particular the <NUM> network, has at least a bandwidth of greater than <NUM> Mbit/sec. Furthermore, according to an embodiment of the invention, it is provided that the network, in particular the <NUM> network, has at least a typical latency of less than <NUM>.

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 one 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, according to one embodiment of the invention, it is provided that the medical device is one of the following medical devices:.

Furthermore, according to one 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 the <NUM> network, via a second communication interface.

Furthermore, according to one 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 <NUM> network.

According to a further embodiment of the invention, it is provided that the medical device or implant comprises a detection unit for signaling interruptions of a connection to the network, e.g., the <NUM> network, which activates a basic supply unit that ensures a basic function of the medical device.

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

A second aspect of the present disclosure, which is not part of the invention, relates to a medical device, in particular with limited power supply, such as an implantable active implant for implantation in human or animal tissue, wherein the medical device is provided with a modem for direct communication with a network, in particular a <NUM> network or a comparable or higher level network.

In other words, this second aspect of the disclosure describes the integration of active implants and implant systems or comparable medical devices into preferably <NUM>-based networks and subsequent network generations, wherein the implant can dial directly into the <NUM> network according to the invention, i.e., has a <NUM> modem and preferably has corresponding functions for energy management.

This second aspect of the disclosure solves in particular the problem of directly connecting active medical devices with limited power supply capabilities to <NUM>-based networks (or higher).

Furthermore, a third aspect of the disclosure, which is not part of the invention, relates to a medical device, in particular with limited power supply, such as for example an implantable active implant for implantation in human or animal tissue, wherein the medical device comprises at least one function for evaluating signals or at least one function for delivering therapy, and at least one of these functions requires timely regulation or control or evaluation for correct function, and wherein the medical device comprises an interface to a network, in particular to a <NUM> network or to a comparable or higher level network, wherein the interface is adapted to be able to communicate directly with the network, e.g. the <NUM> network, on demand and via the network communication, e.g. <NUM> network communication, at least one of the aforementioned functions of the medical device can be directly or indirectly influenced, and wherein the medical device has an interface designed for the network communication, e.g. <NUM> network communication exclusively or non-exclusively allocated power management unit, and, optionally, a power supply unit adapted to power the network communication, e.g., <NUM> network communication, in an energetically proportionate manner to the overall function of the medical device.

The second and third aspects of the disclosure may further be supplemented or further illustrated by the following embodiments.

Accordingly, one embodiment provides a power management unit that manages allowable power budgets or limits for operating network communications (e.g., <NUM> network communications) and enables operation only when the corresponding budget is still available or the limit is not exceeded.

These budgets and limits are preferably differentiated depending on the importance of the current network communication, in particular <NUM> network communication, i.e., there are function- or situation-dependent budgets and/or limits.

According to a further embodiment, the power management unit manages / accomplishes a recharging of a rechargeable power source of the medical device to provide network communication, e.g., <NUM> network communication, and controls the enabling of the network communication depending on the state of charge of the rechargeable power source.

According to a further embodiment, it is provided that the power management unit allows network communication (e.g., <NUM> network communication) always (only) when an energy-intensive function of the medical device is imminent or already taking place, e.g., the charging process of an ICD.

Furthermore, according to one embodiment, it is provided that the network, in particular the <NUM> network, has at least a bandwidth of greater than <NUM> Mbit/sec.

Furthermore, according to an embodiment, it is provided that the network, in particular the <NUM> network, has at least a typical latency of less than <NUM>.

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

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

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

Further, according to one embodiment, the medical device is one of the following medical devices: an active implant, a catheter, a pump, an imaging system, an active VI system, a pacemaker, a wireless pacemaker, a transvenous or non-transvenous implantable defibrillator, a neurostimulator of 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), or an implant for monitoring (e.g., medical prostheses, patient activity or compliance, patient medication). e.g., as a relay station for communication with one or more further implants), or an implant for monitoring (e.g., medical prostheses, patient activity or compliance, patient medication).

Furthermore, according to one embodiment of the invention, said interface of the medical device is formed by a first communication interface, which is used for communication between the medical device and a further communication device, and by the further communication device, which is connected or connectable to the network, in particular the <NUM> network, via a second communication interface.

Finally, according to one embodiment, it is provided that the medical device comprises a detection unit for signaling interruptions of a connection to the network, in particular the <NUM> network, which is adapted to activate a basic supply unit of the medical device, which ensures a basic function of the medical device. Furthermore, according to one embodiment, it is provided that the medical device comprises a connection quality analysis unit that can predict a probable interruption of a connection to the network, e.g. the <NUM> network, 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:.

<NUM> network technology is characterized by a significantly higher data rate and, more importantly, significantly lower latency (~<NUM>). 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, <NUM> 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 in order to be able to realize real-time control of medical devices and in particular electronic implants with significantly more complex algorithms and principles.

<FIG> illustrates a medical device <NUM> in the form of a <NUM> network-controlled electronic implant, hereinafter referred to as implant <NUM>. This first transmits to a patient's own relay station <NUM> sensor data that the implant <NUM> has recorded. The relay station <NUM> may, for example, take the form of a cell phone or a smart phone. This initial transmission path is required for energy reasons, as the power supply and antenna arrangement (body attenuation) of this implant <NUM> are not designed for direct communication with a <NUM> network.

The sensor data is then transmitted to a <NUM> network via base station <NUM> and a <NUM> satellite <NUM> to a cloud-based real-time evaluation system <NUM>, where it is evaluated and control signals derived from it are transmitted back to the implant <NUM> 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 <NUM>.

In <FIG>, an embodiment of the first aspect of the invention is shown schematically, in the form of 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 ECGs. 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 realized according to the invention, the ECG signal(s) will be sent to the cloud-based evaluation system before a therapy decision is made if there is a sufficient need for therapy, said signals will be evaluated with considerably more complex algorithms, and within a very short time the implant's therapy decision will be confirmed or revoked.

The flow chart for the therapy decision is shown in <FIG>. In this context, according to the invention, the establishment of the <NUM> connection is carried out by a predetection unit, which activates the <NUM> network connection only when there is an immediate need for real-time evaluation or influence, here exemplified by a cloud-based rhythm analysis. The invention thus enables completely new, more complex possibilities for controlling and evaluating medical devices, in particular active implants, addressing in particular the problem of the energetically costly <NUM> network connection when the energy supply of the medical device is limited.

In <FIG>, an embodiment of the second aspect of the invention is illustrated by means of a <NUM> network-controlled electronic implant <NUM>. According to the invention, this transmits sensor data recorded by the implant <NUM> directly by means of a <NUM> modem to a <NUM> network via base station <NUM> and a <NUM> satellite <NUM> and subsequently to a cloud-based real-time evaluation system <NUM>.

The control signals evaluated there and derived therefrom in real time are transmitted back to the implant <NUM> via the aforementioned communication system, so that one or more implant functions can be adjusted here in real time, such as therapy delivery or therapy adjustment. The difference between this and automated remote programming of an implant is that the influence on the control function is near real-time, and thus key implant algorithms for implant control can be moved to the cloud-based evaluation system <NUM>.

Finally, <FIG> shows a block diagram of an embodiment of a medical device <NUM> or medical product according to the second or third aspect of the invention. This has a sensor and/or therapy device <NUM> for recording body-related or procedure-related sensor signals, typically connected to a device A directly or indirectly contacting/touching or influencing the body tissue. Further, the device or medical device <NUM> has a power source <NUM> and an (optional) power management unit <NUM> and a communication unit <NUM> for direct communication with a <NUM> network <NUM>. The communication unit <NUM> is implemented as a <NUM> modem, which has a power consumption owed to the network communication and cannot be activated without limitation in case of limited capacities of the power source <NUM>.

In this block diagram, for example, an implantable defibrillator (ICD) is shown. Here, the therapy device <NUM> corresponds to the detection and therapy control unit of the ICD. The power source <NUM> is the primary battery of the ICD. Here, the power management unit <NUM> is configured to establish a network connection to a <NUM> network only whenever a charging operation of the shock capacitors of the ICD therapy device <NUM> is imminent.

Such a charging process has a significantly larger energy requirement than a <NUM> network communication for confirming the therapy decision, so that here the energy use for the "online" confirmation of the therapy decision is classified as appropriate by the power management unit <NUM> and the communication is enabled.

Claim 1:
Medical device (<NUM>; <NUM>), in particular implantable active implant for implantation in human or animal tissue, comprising:
- a unit adapted to perform at least one of the following functions: evaluation of signals and therapy delivery;
- an interface to a network (<NUM>, <NUM>, <NUM>, <NUM>), in particular a <NUM> network, wherein the interface can communicate directly or indirectly with the network as required and the at least one function can be influenced directly or indirectly via the network communication; and
- a predetection unit that activates a connection to the network only whenever an immediate need for real-time assessment and/or influence has been detected by the predetection unit,
characterized in that
the predetection unit is influenced with respect to its sensitivity by a remaining energy supply of the medical device (<NUM>).