System for Generating an Alert for a Systemic Infection

Abstract

An implantable medical device comprises a functional device for carrying out a therapeutic or diagnostic function, and a communication device for communicating with a remote monitoring system. The communication device, at a start of initial operation of the implantable medical device, is enabled to establish a communication with said remote monitoring system. In this way an implantable medical device is provided which allows for including the implantable medical device in a remote monitoring while reducing a risk for a patient involved with attending to the patient for activating a remote monitoring function within the implantable medical device.

Claims

1. An implantable medical device, comprising: a functional device for carrying out a therapeutic or diagnostic function, and a communication device for communicating with a remote monitoring system wherein the communication device, at a start of initial operation of the implantable medical device, is enabled to establish a communication with said remote monitoring system, wherein the communication device is configured to transmit a transmit signal repeatedly according to a predefined first time scheme to establish a communication with said remote monitoring system, wherein the communication device is configured to transmit said transmit signal repeatedly at a regular first time interval to establish a communication with said remote monitoring system, wherein said transmit signal is configured to trigger said remote monitoring system to establish a communication connection to the implantable medical device, and wherein the repeated transmission of the transmit signal requires a current consumption of less than 20 mAs per day.

2. The implantable medical device of claim 1, wherein the communication device is configured to communicate with the remote monitoring system using a pre-defined communication protocol.

3. The implantable medical device of claim 2, wherein the communication protocol is MICS, BLE or Zigbee.

4. The implantable medical device of claim 1, wherein the start of initial operation corresponds to an initial activation of the implantable medical device at or subsequent to implantation.

5. The implantable medical device of claim 1, wherein the implantable medical device is configured to remain operative within a patient over a time of operability, wherein the communication device is enabled to establish said communication with said remote monitoring system over the entire time of operability.

6. The implantable medical device of claim 1, wherein the implantable medical device is configured to initiate at least one communication function on the occasion of establishment of a communication connection with the remote monitoring system.

7. The implantable medical device of claim 6, wherein the implantable medical device is configured, within the at least one communication function, to transmit monitoring data to the remote monitoring system.

8. The implantable medical device of claim 6, wherein the implantable medical device is configured, within the at least one communication function, to transmit monitoring data to the remote monitoring signal repeatedly according to a predefined, second time scheme.

9. The implantable medical device of claim 6, wherein the implantable medical device is configured, within the at least one communication function, to repeatedly transmit monitoring data to the remote monitoring signal at a regular, second time interval.

10. The implantable medical device of claim 6, wherein the implantable medical device is configured to activate the communication function only if a specific activation criterion is fulfilled.

11. The implantable medical device of claim 10, wherein the activation criterion is that the last successful communication with the remote monitoring system may not be longer ago than one month.

12. The implantable medical device of claim 10, wherein the activation criterion is that in a pre-defined previous time span a specified number of successful communication connections have been established in between the implantable medical device and the remote monitoring system.

13. A system comprising an implantable medical device of claim 1 and a remote monitoring system for communicating with the implantable medical device.

14. The system of claim 13, wherein the remote monitoring system is configured to receive a transmit signal from the implantable medical device and to initiate a channel allocation procedure in a specified frequency band for establishing a communication connection with the implantable medical device in case said transmit signal is received.

15. A method for operating an implantable medical device, comprising: providing said implantable medical device, the implantable medical device including a functional device for carrying out a therapeutic or diagnostic function, and a communication device for communicating with a remote monitoring system; wherein said step of providing said implantable medical device includes that the communication device, at a start of initial operation of the implantable medical device, is enabled to establish a communication with said remote monitoring system, wherein the communication device is configured to transmit a transmit signal repeatedly according to a predefined first time scheme to establish a communication with said remote monitoring system, wherein the communication device is configured to transmit said transmit signal repeatedly at a regular first time interval to establish a communication with said remote monitoring system, wherein said transmit signal is configured to trigger said remote monitoring system to establish a communication connection to the implantable medical device, and wherein the repeated transmission of the transmit signal requires a current consumption of less than 20 mAs per day.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0046] The idea(s) behind the present invention shall subsequently be explained in more detail by referring to the embodiments shown in the figures. Herein:

[0047] FIG. 1 shows a schematic view of a system for a remote (home) monitoring of a patient carrying an implantable medical device;

[0048] FIG. 2 shows a schematic view of an implantable medical device;

[0049] FIG. 3 shows a schematic drawing of a communication device of an implantable medical device in communication with a remote monitoring system;

[0050] FIG. 4 shows a schematic flow diagram of establishing a communication between an implantable medical device and a remote monitoring system; and

[0051] FIG. 5 shows a schematic flow diagram of a communication function for communicating between an implantable medical device and a remote monitoring system.

DETAILED DESCRIPTION

[0052] FIG. 1 shows a schematic illustration of a system for a remote (home) monitoring of a patient P carrying an implantable medical device 1.

[0053] The system comprises an implantable medical device 1 implanted in a patient P, the implantable medical device 1, for example, being a cardiac stimulation devices such as a pacemaker device or a defibrillator device, for example, an implantable pulse generator (IPG) such as an implantable cardiac pacemaker, an implantable cardioverter-defibrillator (ICD), a cardiac resynchronization therapy device (CRT) such as a cardiac resynchronization therapy pacemaker or a cardiac resynchronization therapy defibrillator, a neuro stimulator, an insulin pump or an implantable loop recorder or any other implantable active electronic device for performing a therapeutic or diagnostic function within a patient P.

[0054] The implantable medical device 1 constitutes an active electronic implant which is configured and enabled to communicate, in an implanted state within a patient P, with a remote monitoring system 2 external to the patient P. The remote monitoring system 2 may comprise one or multiple portable devices, also denoted as patient relay devices having the shape of mobile communication-enabled devices, which are placed in the home of the patient P and serve to communicate with the implantable medical device 1 to exchange information with the implantable medical device 1 using a communication path A1, for example, according to a communication technology using the MICS protocol, the BLE protocol or the Zigbee protocol.

[0055] The remote monitoring system 2 is, in one embodiment, in communication connection with an information system 3 by means of a communication path A2, the communication path A2 being established, for example, via a public communication network such as the Internet or a telecommunications network, for example, a mobile communication network such as a 2G, 3G, 4G or 5G telecommunications network. The remote monitoring system 2 generally functions as a relay to transmit information from the implantable medical device 1 to the information system 3, or from the information system 3 to the implantable medical device 1.

[0056] The information system 3 may be configured to process data received from the implantable medical device 1 via the remote monitoring system 2. Processed data may be provided to an access device 4 of healthcare personnel, for example a physician D, via a communication path A3, for example, by means of a web interface to which the access device 4 may connect for accessing the data on the information system 3. In addition, the information system 3 may provide messages, such as alert messages, to a specified communication terminal 5 belonging, for example, to the patient P or a person familiar with the patient P via a data communication path A4, and to the remote monitoring system 2 via a communication path A5.

[0057] The implantable medical device 1 generally is configured to perform a function in a patient over a prolonged period of time, such as a measurement function or a cardiac or neuronal stimulation function. For example, the medical device 1 shall remain functional within in a patient for multiple years and in this course shall record and communicate measurement data to the remote monitoring system 2, so that the measurement data may be used to diagnose or monitor the condition of the patient.

[0058] Such an implantable medical device 1 generally is small in size. As schematically shown in FIG. 2, the medical device 1, for example, comprises a housing 15 encompassing an electronic functional device 10 which is formed, for example, by a processor and serves to perform a predetermined function, for example, a measuring function or a therapy function. The medical device 1 in addition comprises a memory 11, e.g., in the form of a RAM (Random Access Memory), (optionally) a wake-up device 12, an energy storage 13, for example in the form of a battery, and a communication device 17 for communicating with remote monitoring system 2. The different functional units are encapsulated in the housing 15 in a fluid-tight manner and are interconnected, for example, by a bus system 16 for a data exchange in between the different devices.

[0059] The medical device 1 in addition, in the shown embodiment, comprises a measurement sensor 14, which is used together with the functional device 10 to perform a measurement in order to record one or multiple physiological parameters, for example, to measure the patient’s body temperature, the heart rate, the heart rate at rest, respiration parameters, an activity parameter or other parameters within the patient P. Measurements may be repeatedly performed in predetermined measurement periods, with measurement data being stored, e.g., temporarily in the memory 11 during a measurement and communicated to the remote monitoring system 2 via the communication device 17.

[0060] The measurement sensor 14 may, for example, be an electrode which is in contact with tissue in the vicinity of the implanted medical device 1, or which is placed on a lead extending from the medical device 1 towards a location of interest. By means of the measurement sensor 14, for example, an electrocardiogram signal may be recorded, the electrocardiogram signal allowing for a sensing of the heart rate and the heart rate at rest.

[0061] In order to reduce the energy consumption of the medical device 1, in one embodiment the functional device 10 or certain functions of the functional device 10 possibly do not operate continuously and at all times, but may be switched from a switched-off state to an operational state when required in order to carry out a function in the operational state. In the switched-off state the functional device 10 or certain functions may be switched off. In order to transfer the functional device 10 or certain functions of the functional device 10 from the switched-off state to the operational state, the wake-up device 12 is provided, which serves to switch on the functional device 10 or certain functions of the functional device 10 based on a signal provided, e.g., from an external activator device, such as the remote monitoring system 2.

[0062] Generally, when an implantable medical device 1 shall be included in a remote monitoring using a remote monitoring system 2, a patient P carrying an implantable medical device 1 needs to visit a physician, which generally has to access the implantable medical device 1 by means of a programming device in order to activate a communication function, thus enabling the implantable medical device to communicate with a remote monitoring system 2. After activation, a communication in between the implantable medical device 1 and the remote monitoring system 2 may be established, such that data may be exchanged in between the implantable medical device 1 and the remote monitoring system 2.

[0063] E.g., in a situation of a general pandemic, such as the COVID-19 pandemic, there is a general desire to keep the risk for a patient P as low as possible, in particular avoiding any unnecessary, potentially risky contacts for the patient P. Hence, there is a desire to avoid a necessity for the patient P to visit a physician in order to activate a remote monitoring function of the implantable medical device 1.

[0064] For this it is proposed that the communication device 17 of the implantable medical device 1, from the initial start of operation of the implantable medical device 1, is enabled to establish a communication with a remote monitoring system 2. Hence, from its start of operation the implantable medical device 1 is enabled to communicate with a remote monitoring system 2, such that no particular activation is required if the implantable medical device shall, at any time, be included in a remote (home) monitoring.

[0065] The implantable medical device 1 hence, over its entire life span, is enabled to detect the presence of a remote monitoring system 2, and if a remote monitoring system 2 is present, the implantable medical device 1 may initiate a communication in between the remote monitoring system 2 and the implantable medical device 1. Accordingly, if a remote monitoring shall be started, it only is required to deliver the remote monitoring system 2, for example, a remote monitoring device in the shape of a so-called patient relay device, to the patient P, upon which the patient P starts operation of the remote monitoring system 2 by plugging the remote monitoring system 2 into a power connection and switching on the remote monitoring system 2. Once the implantable medical device 1 detects the presence of the remote monitoring system 2, communication may be started, and data may be exchanged in a one-directional or bi-directional fashion in between the implantable medical device 1 and the remote monitoring system 2.

[0066] Referring now to FIG. 3, in one embodiment a communication in between the implantable medical device 1 and the remote monitoring system 2 may be established in that the implantable medical device 1 triggers the remote monitoring system 2 to establish the communication. For example, the communication device 17 of the implantable medical device 1 may comprise a transmitter 170 for transmitting a transmit signal T towards the remote monitoring system 2, and a receiver 171 for receiving a response signal R from the remote monitoring system 2. The transmitter 170 and the receiver 171 may use a common antenna 172 for transmitting respectively receiving signals, wherein the communication device 17 may use a specified frequency band, for example, the MICS band in between 401 MHz and 406 MHz, to communicate with the remote monitoring system 2 according to the MICS protocol.

[0067] Referring now to FIG. 4, in one embodiment the implantable medical device 1 is configured to repeatedly send out transmit signals T according to a predefined time scheme, for example, at a fixed repetition rate RP1, for example, once every few hours, once a day or once a week. The transmit signal T in each case may have the shape of a simple triggering command, the transmit signal T causing the remote monitoring system 2, upon reception, to initiate a channel allocation procedure for establishing a communication channel for communicating with the implantable medical device 1.

[0068] In one embodiment, the implantable medical device 1 repeatedly transmits the transmit signal T and awaits a response signal R from a remote monitoring system 2. If no response signal R is received, no further action is taken at the implantable medical device 1 for establishing a communication, until another transmit signal T is transmitted according to the predefined time scheme.

[0069] As the transmit signal T may have a simple shape, and as a reception window, during which the receiver 171 is active, for receiving a response signal R following the transmission of a transmit signal T may be short, the repeated transmission of the transmit signal T to trigger a communication with a remote monitoring system 2 may take place energy efficiently, requiring, for example, in one embodiment, a current consumption of less than 20 mAs per day, beneficially less than 10 mAs per day.

[0070] If the overall energy capacity of the energy storage 13 is, for example, 800 mAs and the estimated overall life span of the implantable medical device 1 without the search function for establishing a communication with a remote monitoring system 2 is 12 years, a current consumption of, for example, 5.6 mAs per day for the search for a remote monitoring system 2 represents a reduction of the operative lifespan of the implantable medical device 1 by less than 1% (37 days). The search function for triggering a communication with a remote monitoring system 2 hence does not substantially reduce the lifespan of the implantable medical device 1.

[0071] If, at a certain time, a remote monitoring system 2 is present, as shown in FIG. 4, the remote monitoring system 2 receives the transmit signal T, upon which the remote monitoring system 2 initiates a channel allocation procedure and establishes a communication channel, for example, a channel or a combination of channels within the MICS band. In the course of the channel allocation, the remote monitoring system 2 sends a response signal R to the implantable medical device 1 for agreeing on the communication channel (in a hand-shake type fashion), upon which the implantable medical device 1 may reply with an acknowledgment signal ACK, hence concluding the channel allocation. Once the communication channel is established, data messages M may be exchanged, for example, one-directionally from the remote implantable medical device 1 to the remote monitoring system 2, or bi-directionally in between the implantable medical device 1 and the remote monitoring system 2.

[0072] Referring now to FIG. 5, in case a communication in between the implantable medical device 1 and a remote monitoring system 2 is established and hence the implantable medical device 1 knows about the presence of a remote monitoring system 2, the implantable medical device 1 may switch on a communication function in order to exchange data with the remote monitoring system 2. The activation of the communication function herein may take place immediately at the first time that a remote monitoring system 2 is detected to be present, or may take place according to one or multiple defined activation criteria, requiring, for example, that in a predefined previous time span a specified number of successful communication connections have been established in between the implantable medical device 1 and the remote monitoring system 2, for example, ten communication connections in the last week or so.

[0073] Within the communication function, a data transmission one-directionally from the implantable medical device 1 to the remote monitoring system 2 or bi-directionally in between the implantable medical device 1 and the remote monitoring system 2 may take place according to a second time scheme different than the time scheme according to which the transmit signals T have been sent in the search phase by the implantable medical device 1 when searching for the presence of a remote monitoring system 2.

[0074] As illustrated in FIG. 5, once the communication function is activated by the implantable medical device 1, a data transmission may take place in transmission periods TP, for example, at a repetition rate RP2 which is smaller than the repetition rate RP1 at which the transmit signals T have been sent during the search phase when searching for the remote monitoring system 2. Within each transmission period TP, herein, a data transmission is initiated by a transmit signal T sent by the implantable medical device 1, upon which the remote monitoring system 2 responds with a response signal R and awaits an acknowledgment signal ACK from the implantable medical device 1 to allocate a communication channel for communicating with the implantable medical device 1. Each transmission period TP hence is triggered by the implantable medical device 1, upon which a channel allocation procedure is performed by the remote monitoring system 2.

[0075] The idea(s) underlying the present invention is not limited to the embodiments described above, but may be implemented in an entirely different fashion.

[0076] Because an implantable medical device over its entire lifespan is enabled to communicate with a remote monitoring system, the implantable medical device may be included in a remote monitoring at any time, requiring simply a delivery of the remote monitoring system towards the patient, upon which a communication with the implantable medical device is established automatically. A patient hence does not have to attend to a physician in order to activate a remote monitoring function of the implantable medical device, hence reducing a logistical burden and a health risk for the patient.

[0077] As the search function of the implantable medical device for searching for a remote monitoring system may be implemented in an energy efficient way, the continuous enablement of the implantable medical device to be included in a remote monitoring does not significantly shorten the lifespan of the implantable medical device.

[0078] 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.

TABLE-US-00001 List of reference numerals 1 Implantable medical device 10 Functional device 11 Memory device 12 Wake-up device 13 Energy storage 14 Sensor device 15 Housing 16 Bus system 17 Communication device 170 Transmitter 171 Receiver 172 Antenna 2 Patient monitoring device 3 Monitoring service center 4 Access device 5 Communication terminal A1-A5 Communication path ACK Acknowledgement message D Physician M Data message P Patient R Response signal RP1, RP2 Repetition interval T Transmit signal TP Transmission period