Waiting room triggered interrogation

A local communication unit automates the collection and transfer of medical data from multiple implantable devices, addressing inefficiencies in existing data retrieval methods by providing timely and efficient access to patient health information.

WO2025214859A1PCT designated stage Publication Date: 2025-10-16BIOTRONIK SE & CO KG
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Patent Information

Application Number
PCT/EP2025/059067
Authority / Receiving Office
WO · WO
Patent Type
Applications
Current Assignee / Owner
Priority Date
2024-04-08
Filing Date
2025-04-03
Publication Date
2025-10-16

AI Technical Summary

Technical Problem

The process of obtaining medical data from implantable devices is time-consuming and inefficient, leading to delays in treatment and increased workload for healthcare professionals, as it often requires manual data transfer and can waste valuable appointment time.

Method used

A local communication unit that automatically receives discovery messages from multiple implantable medical devices, sends data request messages, and collects medical data sets via local wireless communication, which are then forwarded to a central communication unit for processing and indication of availability.

Benefits of technology

This system automates the collection and transfer of medical data, reducing the time and effort required for data retrieval, ensuring timely access to current patient health information without overburdening the implantable devices.

✦ Generated by Eureka AI based on patent content.

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Abstract

A local communication unit adapted for communication with a plurality of implantable medical devices. The local communication unit comprises means for receiving a discovery message from an implantable medical device via a local wireless communication and means for transmitting a data request message to the implantable medical device via the local wireless communication upon receiving the discovery message. The local communication unit further comprises means for receiving a medical data set from the implantable medical device via the local wireless communication upon transmitting the data request message.
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Description

[0001] Waiting room triggered interrogation

[0002] The present invention relates to an implantable medical device, a local communication unit and a central communication unit for automatically providing a medical data set of the implantable medical device to the central communication unit and, in some examples, automatically indicating the availability of the medical data set.

[0003] When a patient with an implantable medical device, e.g., an implanted medical device, arrives for a doctor’s appointment or in a hospital, the medical staff needs to interrogate the patient’s implant with a programming instance to get the actual implant dataset, that is, data that relates to the implant and / or medical data of the patient that has been measured by the implant. However, obtaining this data by means of the programming instance is a time-consuming process, which delays the treatment and renders the workflow in the doctor’s office inefficient. Besides, this results in additional work for the health professionals and the patient and further patients have to wait for upcoming appointments.

[0004] Furthermore, the medical staff may not know if a patient wears an implanted medical device, and even if they do, sending an interrogation request using the programming instance, may result in a time-consuming interrogation to retrieve the medical data set, wasting valuable time during the appointment.

[0005] In particular, when the medical data set is configured to include recent after-care data, e.g., medical data that has to be generated when the programming instance initiates the interrogation, the process of generating such medical data, e.g., wherein the implantable medical device actively measures medical data, can consume a substantial amount of time.

[0006] Also, when the interrogation of the implantable medical device with the programming instance has finished, the medical data is not necessarily automatically provided to the doctor. In fact, the medical data must often be presented manually, either in a digital form, e.g., by writing the medical data in a patient’s file, or in a physical form, e.g., handwritten, to the doctor. This introduces an additional step in providing the medical data to the doctor, i.e., the person responsible for the medical treatment and increases the overhead work.

[0007] Therefore, there is a need to optimize and to automatize the provision of medical data of an implantable medical device of a patient.

[0008] This is met at least in part by the various aspects of the invention outlined herein.

[0009] According to one aspect of the present invention, a local communication unit adapted for communication with a plurality of implantable medical device is provided. The local communication unit comprises means for receiving a discovery message from an implantable medical device via a local wireless communication, means for transmitting a data request message to the implantable medical device via the local wireless communication upon receiving the discovery message as well as means for receiving a medical data set from the implantable medical device via the local wireless communication upon transmitting the data request message.

[0010] The local communication unit is configured to communicate with a plurality of implantable medical devices. In other words, the local communication unit is not configured to only interact, e.g., to interrogate, with a single, distinguished implantable medical device, but with a plurality of implantable medical devices, e.g., one after another. In particular, the plurality of implantable medical devices may not be specified a priori and may be defined as an entirety of all adapted implantable medical devices.

[0011] Therefore, the local communication unit can receive the medical data set from a plurality of implantable medical devices, which offers the possibility of using the local communication unit in a waiting room or in a hospital, where a plurality of patient’s may be present.

[0012] In some examples, an implantable medical device may enter into a region around the local communication unit, such that a discovery signal that the implantable medical device may send (e.g., periodically), can be received by the local communication unit. Upon receipt of the discovery signal (e.g., in response thereto), a data request message may be (automatically) sent. Upon receipt of the data request message (e.g., in response thereto) a corresponding medical data set can automatically be sent, for example. Thus, medical data sets from implantable devices may be automatically collected, e.g., in a use can in a waiting room, the medical data sets may be collected automatically from a larger number of implantable medical devices which are present in the waiting room.

[0013] The means for receiving the discovery message are adapted to receive a discovery message from an implantable medical device via a local wireless communication. The discovery message may comprise a minimal data packet which is necessary for establishing a connection with the local communication unit. The wireless communication between the local communication unit and the implantable medical device may be a local wireless communication. For example, the local wireless communication may be a direct wireless communication. After establishing a connection, a local communication link may be present, e.g., a link wherein the transmitted data can be localized within a given area. For example, a local link may be a link wherein the data is not transmitted to a third party, which may be localized outside the given area.

[0014] In some examples, the local communication unit, upon receiving the discovery signal, sends a request to the implantable device to establish the connection. In other examples, the local communication unit may directly send the data request message upon receiving the discovery signal.

[0015] The means for transmitting a data request message to the implantable medical device are configured to transmit the data request message via the local wireless communication upon receiving the discovery message. In other words, the data request message may generally send via the same communication channel as the discovery message. In other embodiments, the data request message may be sent via a communication channel based on information comprised in the discovery message. For example, the discovery message may comprise information and / or instructions for configuring a communication channel or communication link over which the data request message is transmitted.

[0016] The means for receiving a medical data set from the implantable medical device are configured to receive the medical data set via the local wireless communication upon transmitting the data request message. In general, the means for receiving the discovery message may coincide with the means for receiving the medical data set. Alternatively, the means for receiving the discovery message may be different from the means for receiving the medical data set.

[0017] Generally, the medical data set may comprise one or more current after-care records. In addition, or alternatively, the medical data set may be based on the data request message. Including one or - fl - more after-care records into the medical data set may render the manual interrogation superfluous as the implantable medical device can communicate automatically with the local communication unit. Further, if the medical data set is based on the data request message, the medical data included in the medial data set can be influenced. For example, the data request message may specify which medical data is to be included in the medical data set. In general, the data request message may depend on the particular implantable medical device, e.g., the data request message for a pressure sensor implant may differ from the data request message for a cardiac rhythm implant. In other embodiments, the data request message may specify whether the medical data set comprises one or more current after-care records. In addition, or alternatively, the data request message may specify which subset of after-care records are current after-care records. For example, the data request message may comprise time information, and after-care records which were recorded at a time within a certain threshold around a time indicating by the time information may be used as current after-care records. In other examples, a receipt time of the data request message may be used instead of or in addition to time information comprised by the data request message (if any).

[0018] Specifically, at least a part of the current after-care records may be based on medical data which is generated and / or measured after the data request message is received by the implantable medical device. Using current after-care records which are based on medical data which is generated and / or measured after the data request message is received may guarantee that the medical data set received by the local communication unit reflects the actual, current health situation of the patient.

[0019] In general, the local communication unit may further comprise means for transmitting data to a central communication unit for processing, e.g. via a network, preferably wherein the transmitted data may be at least partially based on the received medical data set. The means for transmitting may be configured to transmit the data via the network to a central communication unit for processing. For example, the data transmitted to the network for processing may be at least partially based on the received medical data set. In particular, the local communication unit may forward the medical data set or at least a portion thereof to the central communication unit. In other embodiments, the local communication unit may modify the format and / or the coding of the medical data set and / or may modify the medical data set according to an encryption method. The network may be a wireless network, comprising wireless data connections between network nodes. For example, the wireless network may comprise WPAN, WLAN, W AN, GAN and / or general cellular networks as GSM, PCS, LTE and / or 5G. In general, the central communication unit may not be a direct part of the local communication link. Furthermore, the number of data request messages transmitted from the local communication unit to the implantable medical device via the local wireless communication link in a time interval may be bound by an upper limit. In some embodiments, at most one request message is transmitted to the implantable medical device within an hour. Alternatively, at most one request message is transmitted to the implantable medical device within a day.

[0020] In other words, the number of data request messages which the local communication unit transmits to the implantable medical device within a time interval cannot exceed a limit value. In general, a data request message may only be counted if a corresponding medical data set is received afterwards, i.e., an unsuccessful request of medical data does not contribute to the number of data request messages. For example, an unsuccessful request of medical data may be caused by an insufficient quality of the wireless local communication link. Therefore, even if the number of unsuccessful requests exceeds the threshold, it is still possible to obtain the medical data set form the implantable medical device.

[0021] In general, bounding the number of possible data request messages which are sent to the implantable medical device ensures that the implant is not forced to generate and / or to measure the medical data set more often within the time interval than specified by the upper limit. This guarantees that the energetic resources of the implantable medical device are treated with care. For example, by transmitting at most one request message to the implantable medical device within a day ensures that the energetic resources are not stressed too much while at the same time guaranteeing a sufficient currentness of the data.

[0022] Generally, the data request message and / or the medical data set may be associated with an identification of the implantable medical device. The identification of the implantable medical device may be comprised in the discovery message. For example, the identification may be based on a serial number of the implantable medical device. Associating the data request message with an identification of the implantable medical device allows to distinguish the implantable medical device from a plurality of other implantable medical devices. For example, only a single implantable medical device may respond to the data request message, e.g., that one with matching identification. This may ensure that the received medical data set can be assigned to a particular implantable medical device and thus to the corresponding patient. By using an identification which is based on a serial number of the implantable medical device may yield a unique and one-to one correspondence between the identification and the implantable medical device. Specifically, the number of request messages transmitted to the implant may be based on the identification of the implantable medical device. For example, the number of request messages transmitted to the implantable medical device may be counted with respect to the identification. In particular, if the number of request messages sent to an implantable medical device associated with the identification exceeds the threshold within a time interval, no further data request messages may be transmitted to the implantable medical device associated with the identification. Therefore, using the identification to keep track of the number of request messages allows for easy controlling without introducing an additional overhead.

[0023] In other examples, additionally or alternatively, the number of medical data set transmissions (per time interval) by an implantable medical device may be limited similarly as described with reference to the number of transmissions (per time interval) of the data request message.

[0024] In general, the local communication unit may be configured to transmit the data request message to the implantable medical device based on the discovery message. In addition, or alternatively, the means for receiving may be configured to scan for the discovery messages. For example, the local communication unit may scan for the discovery message by cyclic scanning.

[0025] In general, the discovery message may comprise information about the type of the implantable medical device. For example, the type of the medical implantable device may be a pressure sensor implant, a rhythm implant, a neurostimulator, a drug pump, a CCM pulse generator, an implantable cardioverter defibrillator. The data request message and / or the parameters of the data request message may depend on the type of the implantable medical device. In addition, or alternatively, the separation of current after-care data and after-care data may depend on the type of the implantable medical device. For example, for a first type of implantable medical device the current after-care data may comprise generated and / or measured data within a first time period, while for a second type of implantable medical device the current after-care data may comprise generated and / or measured data within a second period of time. Specifically, the first and the second period of time may differ.

[0026] Additionally, or alternatively, the discovery message may comprise information about a link quality, e.g., a bit error ratio, a signal-to-noise ratio, a bandwidth or a (transfer) data rate. In response to the discovery message, the data request message and / or the parameters of the data request message may depend on the information about the link quality. For example, the data request message may be adapted to the information about the link quality. The data request message may be adapted to a data transfer rate based on the information about the link quality and / or may comprise instructions to interrogate data based on the information about the link quality.

[0027] Thus, the data request message can be adjusted to an appropriate data transfer rate or to the interrogation of a suitable amount of data from the implant based on the transmitted link quality by the discovery message. This leads to a more efficient and robust communication between the implant and the local communication unit.

[0028] Additionally, or alternatively, the discovery message may comprise information about firmware and / or the type of communication interface of the implant. In response to the discovery message, the data request message and / or the parameters of the data request message may depend on the information about the firmware and / or the type of communication interface of the implant. For example, the data request message may be adapted to the firmware and / or the type of communication interface of the implant. The data request message may be adapted to data and / or data formats based on the information about firmware and / or the type of communication interface of the implant, and / or may comprise instructions to interrogate data based on the information based about firmware and / or the type of communication interface of the implant.

[0029] This ensures an efficient and robust communication between the implant and the local communication unit.

[0030] Additionally, or alternatively, the discovery message may comprise information about an operational mode of the implant and / or an applied therapy by the implant. In response to the discovery message, the data request message and / or the parameters of the data request message may depend on the information about the operational mode of the implant and / or the applied therapy by the implant. For example, the data request message may be adapted to the operational mode of the implant and / or the applied therapy by the implant. The data request message may be adapted to not interrogate predetermined data and / or to interrogate a reduced amount of data, and / or may comprise instructions to not interrogate predetermined data and / or to interrogate a reduced amount of data based on the information about the operational mode of the implant and / or an applied therapy by the implant.

[0031] This ensures a stable and safe operation of the therapy by the implant and an efficient and robust communication between the implant and the local communication unit. Additionally, or alternatively, the discovery message may comprise information about errors and / or erroneous states of the implant. In response to the discovery message, the data request message and / or the parameters of the data request message may depend on the information about errors and / or erroneous states of the implant. For example, the data request message may be adapted to the errors and / or erroneous states of the implant. The data request message may be adapted to not interrogate predetermined data which is effected by the error and / or the erroneous state and / or to interrogate a reduced amount of data, and / or may comprise instructions to not interrogate predetermined data which is effected by the error and / or the erroneous state and / or to interrogate a reduced amount of data based information about an operational mode of the implant and / or an applied therapy by the implant.

[0032] For example, the data request message may be adapted and / or may comprise instructions to interrogate error-log data from the implant. Error-log data enables identification of the error and / or the erroneous state of the implant. Further, the data request message may be adapted to not interrogate erroneous memory sections of the device.

[0033] This ensures an efficient and robust communication between the implant and the local communication unit.

[0034] In one embodiment, the local communication unit may be configured to adapt the data request message based on the discovery message according to the embodiments described above.

[0035] Scanning for the discovery message transmitted by the implantable medical device may be used to identify current implantable medical devices and to determine the state of the devices. For example, scanning for the discovery message may comprise monitoring a set of channels. In particular, a set of channels in a particular frequency regime and / or having a particular bandwidth may be monitored. In general, the scanning may be a section wise scanning, wherein only in certain time intervals the means for receiving scan for the discovery message, while in other time intervals the means for receiving are inactive. Further, the scanning may be a cyclic scanning, i.e., the inactive and active intervals alternate and are of a predefined duration. Section wise scanning reduces the energy consumption of the local communication unit and cyclic scanning ensures that the duration of the inactive intervals is not substantially larger than the active intervals, therefore optimizing the probability of receiving the discovery message. In some embodiments, the duration of the active intervals and / or the inactive intervals and / or the timing of the active intervals and / or the timing of the inactive intervals may be controlled by the central communication unit. According to another aspect of the present invention, an implantable medical device adapted for direct communication with a local communication unit is provided. The implantable medical device comprises means for transmitting a discovery message, means for receiving a data request message from the local communication unit via a local wireless communication link upon transmitting the discovery message and means for transmitting a medical data set to the local communication unit via a local wireless communication link upon receiving the data request message.

[0036] The means for transmitting the discovery message may be configured to transmit the discovery message via a local wireless communication link. In particular, the local wireless communication link may be a broadcast or multicast channel. Further, the discovery message may be a minimal message which only comprises information necessary to establish a communication channel with the local communication unit.

[0037] The means for receiving the data request message are configured to receive the data request message via the local wireless communication link upon transmitting the discovery message. In other words, the data request message may be a response of the local communication unit to the discovery message. The data request message may cause the implantable medical device to generate and / or to prepare a medical data set. The medical data set may comprise medical data which is at least in part specified by the data request message.

[0038] The means for transmitting the medical data set are configured to transmit the medical data set via a local wireless communication link upon receiving the data request message. The local wireless communication link may be the same local wireless communication link used by the means for receiving the data request message. Alternatively, the local wireless communication link may differ from the local wireless communication link used by the means for receiving the data request message. For example, the local wireless communication link may offer a higher throughput and / or a higher bandwidth. By transmitting the medical data set to the local communication unit gains access to medical data generated and / or prepared by the implantable medical device without employing an additional, manually used programming instance.

[0039] Generally, the means for transmitting the discovery message and / or the means for receiving the data request message and / or the means for transmitting the medical data set may be at least partly comprised in a telemetry interface. The telemetry interface may use at least one of the following frequency bands: MICS, MEDS, ISM, Zigbee and BLE. In general, the medical data set may comprise one or more current after-care records. In addition, or alternatively, the medical data set is based on the data request message. A data set comprising one or more current after-care records ensures that the medical data reflects the current actual health status of the patent and / or the current actual status of the implantable medical device.

[0040] Specifically, at least a part of the current after-care records may be based on medical data which is generated and / or measured after the data request message is received by the implantable medical device.

[0041] Generating the medical data and / or the medical data set may comprise accessing medical data which is stored on a storage medium associated with the implantable medical device. In particular, the medical data stored on the storage medium may have been generated before the data request message has been received. In addition, or alternatively, generating the medical data and / or the medical data set may comprise arranging the data in a format appropriate for transmission via the local wireless communication link. In addition, or alternatively, generating the medical data and / or the medical data set may comprise a measurement of properties of the state of the implantable medical device and / or a measurement of medical properties of a patient, wherein the measurement is implemented by the implantable medical device. For example, properties of the state of the implantable medical device may comprise a battery voltage. The measurement of medical properties of a patient may depend on the specific type of implantable medical device and / or on the data request message.

[0042] The implantable medical device may be an electronic and / or active implant.

[0043] Generally, the means for transmitting the medical data set may be configured to transmit the medical data set within a time period starting from the receipt of the data request message bounded by a threshold. For example, the threshold may be at most 30 minutes, preferably at most 20 minutes, more preferably at most 10 minutes, most preferably at most 5 minutes. In addition, or alternatively, the threshold may be based on the data request message.

[0044] Transmitting the medical data set to the local communication unit within a time period bounded by a threshold starting from the receipt of the data request message ensures that the latency of the local communication unit for the medical data set does not exceeds the threshold. Using a threshold of at most 30 minutes guarantees that the medical data set is transmitted to the local communication unit within a typical period a patient must wait in the waiting room. Therefore, a possible delay of the transmission of the medical data set is minimized and the time between transmitting the discovery signal and transmitting the medical data set is optimized. Further, the threshold may depend on the data request message, i.e., the latency of the local communication unit can be steered by the data request message.

[0045] Furthermore, the implantable medical device may be configured to transmit the discovery message in a pattern, preferably a periodic pattern. For example, the discovery message may be transmitted in a periodic pattern wherein the discovery message is transmitted with a period of at most 10 minutes, at most 5 minutes, at most 1 minute, at most 30 seconds, at most 10 seconds.

[0046] In general, transmitting the discovery message in a pattern may comprise an active interval wherein the discovery message is transmitted and an inactive interval wherein no discovery message is transmitted. For example, the active interval may comprise the transmission of at least one discovery message. Specifically, the discovery message may be transmitted in a periodic pattern. For example, the discovery message may be transmitted with a certain period, i.e., after a time associated with the period elapses, the discovery message is transmitted. In particular, using a period of at most 10 minutes may ensure that the time needed in to establish a connection with the local communication unit, i.e., that the local communication unit discovers the transplantable medical device, is bounded.

[0047] According to another aspect of the present invention, a central communication unit adapted for communication with a local communication unit via a network is provided. The central communication unit comprises means for receiving a medical data set from the local communication unit via the network and means for transmitting an indication of an availability of the received medical data set to an authorized user, wherein the indication further indicates an implantable medical device which provided the medical data.

[0048] In general, the central communication unit may be spatially separated from the local communication unit and / or the implantable medical device. For example, the separation may be such that the central communication device is not part of the local wireless communication link. Furthermore, the central communication unit may be configured to communicate with a plurality of local communication units. In general, the central communication unit may be a server and / or a cloud. The means for receiving the medical data set are configured to receive the medical data set from the local communication unit via the network. Generally, the medical data set received from the local communication unit may differ from the medical data set transmitted by the implantable medical device. For example, the local communication unit may modify the format and / or the coding of the medical data set and / or may modify the medical data set according to an encryption method.

[0049] The network may comprise a plurality of third network nodes. For example, the network may comprise at least one, at least three, at least five third network nodes. Furthermore, the means for transmitting the indication of the availability are configured to transmit the indication to an authorized user. The authorized user may be a computer and / or a network associated with a practice and / or a hospital. In general, the indication may not fully comprise the medical data set received from the local communication unit. For example, the indication may only indicate the availability of the received medical data set, without fully disclosing the corresponding medical data.

[0050] Specifically, the received medical data set may comprise the identification of the implantable medical device. The indication may also be adapted to indicate the implantable medical device which provided the medical data set. For example, the indication may comprise information which is based on the identification of the implantable medical device. In particular, this information may be such that the authorized user can infer the identification of the implantable medical device and / or the corresponding patient. Therefore, by receiving the indication the authorized person, e.g., the medical doctor and / or the health professional, may be aware of the availability of a medical data set and / or recent after-care records.

[0051] Specifically, the central communication unit may further comprise means for processing the received medical data set. For example, the processing of the received medical data set may comprise a decoding of the received medical data set. The means for processing the received medical data set may comprise at least one computer and / or at least one processor. The processing of the medical data set comprises a decoding of the received medical data set and optionally also the application of an error correction scheme. In certain embodiments, the processing may also comprise a decryption. For example, after a part of the processing the medical data received from the local communication unit may essentially coincide with the medical data transmitted from the implantable medical device. In addition, or alternatively, the means for processing the received medical data may also generate at least a part of the indication of the availability. In general, the central communication unit may further comprise means for verifying whether the implantable medical device is registered with the central communication unit. For example, the means for processing the medical data set may be configured to process the medical data set if the implantable medical device is a registered implantable medical device. In addition, or alternatively, the means for transmitting the indication may be configured to transmit the indication (only) if the implantable medical device is a registered implanted medical device.

[0052] The means for verifying whether the implantable medical device is registered with a communication unit may comprise comparing the implantable medical device with a deposited list of possible implantable medical devices. If the implantable medical device is part of said deposited list, the implantable medical device may be regarded as a registered implantable medical device. In general, the deposited list may comprise a plurality of identifications of implantable medical device. In this case, the means for verifying may compare the identification of the implantable medical device with the identifications stored in the deposited list. Specifically, the identification may be based on the serial number. In particular, when the discovery message and / or the data request message and / or the transmitted medical data set comprise at least a part of the serial number, the verification may be based on the serial number.

[0053] The means for processing the medical data may be configured to process the medical data of the implantable medical device is registered. In addition, or alternatively, if the implantable medical device is not registered, the means for processing may ignore the received medical data set. Similarly, if the implantable medical device is not registered, the means for transmitting may be configured to not transmit the indication.

[0054] According to another aspect of the present invention a system adapted to automatized provision and / or indication of medical data is provided. The system comprises at least two of the following: a local communication unit according to one of the above-described aspects, an implantable medical device according to one of the above-described aspects, or a central communication unit according to one of the above-described aspects.

[0055] In some embodiments, the local communication unit may transmit a wake-up message adapted to be received by the implantable medical device. In general, the wake-up message may not be addressed to a specific recipient and may be directed to all possible implantable medical devices that are located in a vicinity of the local communication unit. For example, the vicinity may be based on a signal strength of the wake-up message.

[0056] The wake-up message may be transmitted in a pattern, e.g., in a periodic pattern. Specifically, the period and / or transmission time of the wake-up message may be controlled and / or steered by the central communication unit. For example, the wake-up message may be a beacon signal. The wake-up signal may replace the discovery message transmitted by the implantable medical device or may be transmitted in addition to the discovery message. In general, the implantable medical device may receive the wake-up signal, e.g., by scanning for the wake-up signal. Specifically, the implantable medical device may scan periodically for the wake-up signal with a period of at most 10 seconds, at most 30 seconds, at most 60 seconds, at most 2 minutes, at most 4 minutes, at most 10 minutes, at most 1 hour. This reduces the energy consumption of the implantable medical device and thus optimizes the use of the energy resources.

[0057] After receiving the wake-up signal, the implantable medical device may transmit a communication request to the local communication unit. The communication request may be essentially identical to the discovery message described herein. For example, the communication request may be transmitted in response to the wake-up signal. In addition, or alternatively, the communication request and / or the discovery message may be transmitted independently of receiving the wake-up signal, as described herein. If the local communication unit receives the communication request, it may transmit a confirmation to the implantable medical device such that a communication channel and / or a communication session is established.

[0058] Such a system may yield various benefits described herein in reference to embodiments of the implantable medical device, the local communication unit and / or the central communication unit as a system comprising at least two of the above listed parts provides synergistic benefits due to the mutual adjustment of the parts working together in the system.

[0059] In general, the local communication unit and / or the implantable medical device and / or the central communication unit may comprise one or more data processors for processing data, one or more storage devices for storing data, and / or one or more computer programs including instructions that when executed by the one or more computers cause the one or more computers to carry out the processes. Each data processor can include one or more processor cores, and each processor core can include logic circuitry for processing data. For example, a data processor can include an arithmetic and logic unit (ALU), a control unit, and various registers. Each data processor can include cache memory. Each data processor can include a system-on-chip (SoC) that includes multiple processor cores, random access memory, graphics processing units, one or more controllers, and one or more communication modules. Each data processor can include thousands, millions, or billions of transistors. A computer program can be written in any form of programming language, including compiled or interpreted languages, and it can be deployed in any form, including as a stand-alone program or as a module, component, subroutine, or other unit suitable for use in a computing environment. Generally, a processor will receive instructions and data from a read-only storage area or a random access storage area or both. Elements of a computer system include one or more processors for executing instructions and one or more storage area devices for storing instructions and data. Generally, a computer system will also include, or be operatively coupled to receive data from, or transfer data to, or both, one or more machine-readable storage media, such as hard drives, magnetic disks, solid state drives, magneto-optical disks, or optical disks. Machine-readable storage media suitable for embodying computer program instructions and data include various forms of non-volatile storage area, including by way of example, semiconductor storage devices.

[0060] Another aspect of the present invention are various methods that may, for example, be carried out by the implantable medical devices, local or central communication units or systems as described herein. Corresponding examples are:

[0061] A method for communicating with a plurality of implantable medical devices (200) comprising: receiving a discovery message from an implantable medical device (200) via a local wireless communication; transmitting a data request message to the implantable medical device via the local wireless communication upon receiving the discovery message; receiving a medical data set from the implantable medical device (200) via the local wireless communication upon transmitting the data request message.

[0062] In general, the method may be performed by a local communication unit. The method may further comprise transmitting data to a central communication unit (300) for processing, preferably wherein the transmitted data is at least partially based on the received medical data set.

[0063] A method for communicating with a local communication unit (100), preferably performed by an implantable medical device, comprising: transmitting a discovery message via a local wireless communication; receiving a data request message from the local communication unit via the local wireless communication upon transmitting the discovery message; transmitting a medical data set to the local communication unit via the local wireless communication upon receiving the data request message.

[0064] A method for communicating with a local communication unit (100), preferably performed by a central communication unit (300), comprising: receiving a medical data set from the local communication unit, e.g. via a network; transmitting an indication of an availability of the received medical data set to an authorized user (410), e.g. via the network; wherein the indication further indicates an implantable medical device (200) which provided the medical data set.

[0065] In general, the method may further comprise the step of processing the received medical data set, in particular decoding the received medical data set. In addition, or alternatively, the method may further comprise the step of verifying whether the implantable medical device (200) is registered with the central communication unit (300), and / or wherein preferably the indication is transmitted, if the implantable medical device (200) is registered.

[0066] In general, any feature and / or any combination of features of the local communication unit and / or the implantable medical device and / or the central communication unit and / or the system as described herein may also be incorporated into the corresponding method and vice versa, preferably as a procedural step. Generally, the above-described methods and / or their combination may be at least in part implemented in software.

[0067] Fig. 1 Schematic representation of an exemplary local communication unit according to the present invention.

[0068] Fig. 2 Schematic representation of an exemplary implantable medical device according to the present invention.

[0069] Fig. 3 Schematic representation of an exemplary central communication unit according to the present invention.

[0070] Fig. 4 Schematic representation of an exemplary system comprising a local communication unit, an implantable medical device and a central communication unit according to the present invention. Figure 1 shows a schematic representation of an exemplary local communication unit 100. The local communication unit comprises means for receiving 110 a discovery message, means for transmitting 120 a data request message, means for receiving 130 a medical data set and means for transmitting data 140. In general, the means for receiving 110 may coincide with the means for receiving 130. The means 110, 120, 130 and 140 of the exemplary local communication unit 100 may for example be configured to communicate via a wireless, e.g., via cellular radio (e.g., 5G, 4G, etc.), Wi-Fi, infrared, satellite, microwave, Bluetooth) manner and or any other connection and may comprise corresponding transceivers. In the exemplary embodiment of the system 400 (see Fig, 4), the local communication unit 100 is located in a waiting room and / or a hospital. The means for receiving 110, the means for transmitting 120 and / or the means for receiving 130 may be configured to receive and / or transmit within an accessible area 420. The accessible area may comprise the waiting room and / or at least a part of the hospital.

[0071] Figure 2 shows a schematic representation of an exemplary implantable medical device 200. The implantable medical device comprises means for transmitting 210 a discovery message, means for receiving 220 a data request message and means for transmitting 230 a medical data set.

[0072] The implantable medical device may be an implantable electronic medical device, e.g., an implantable pulse generator (IPG), an implantable cardioverter-defibrillator (ICD), a cardiac resynchronisation therapy-defibrillator (CRT), an implantable loop recorder, a neurostimulator, a medication pump, a ventricular assist device (VAD), a cardiac contractility modulation (CCM) pulse generator or an implanted pressure sensor, etc.

[0073] The transmitted medical data set may depend on the particular type of the implantable medical device (200). For example, if the implantable medical device 200 is an IPG, an ICD, a CRT or an implantable loop recorder, the medical data set may comprise data of at least one episode. For example, it may comprise at least one electrocardiograph (ECG) and / or an intracardiac electrogram (IEGM) signal. It may comprise one or more parameters of ECG and / or IEGM signals that were flagged as episodes, statistics of episodes, etc. The medical data set may further comprise a set of at least one predefined and / or programmed parameter and / or a stimulus threshold and / or one or more impedances and / or signal amplitudes and / or a battery voltage. In some embodiments, the ECG and / or the IEGM have been generated after the means for receiving 220 have received the data request message. Alternatively, or in addition, the ECG and / or the IEGM have not been generated / measured before a date specified by the data request message. If the medical device is an implantable pressure sensor, the medical data set may comprise data from at least one pressure measurement. For example, the pressure may be measured after the means for receiving 220 receive the data request message. The medical data set may further comprise predefined and / or programmed parameters and / or pressure measurements that have been conducted before the means for receiving 220 have received the data request message and / or an average pressure value and / or a minimal pressure value and / or a maximal pressure value and / or a battery voltage.

[0074] The implantable medical device may comprise a telemetry interface, wherein the telemetry interface is at least used for receiving a data request message and for transmitting a medical data set. In some embodiments the telemetry interface may additionally be used for transmitting the discovery message. The telemetry interface may use at least one of the following frequency bands: the medical implant communication service (MICS), the medical device radiocommunications service (MEDS), the industrial, scientific and medical (ISM) band, Zigbee and / or the Bluetooth low energy (BLE) band.

[0075] Figure 3 shows a schematic representation of an exemplary central communication unit 300. The central communication unit 300 comprises means for receiving a medical data set 310, means for transmitting an indication 320, and optionally means for processing 330 and means for verifying 340.

[0076] Figure 4 shows a schematic representation of an exemplary system 400 comprising the local communication unit 100, the implantable medical device 200, the central communication unit 300 and the authorized user 410.

[0077] Initially, when the patient with the implantable medical device 200 enters the area 420, the implantable medical device 200 and the local communication unit 100 may be unconnected. The means for transmitting 210 a discovery message of the implantable medical device 200 may transmit, e.g. in a periodic pattern, the discovery message. For example, the discovery message may be transmitted with a period of 10 seconds, 30 seconds, 60 seconds, 2 minutes, 4 minutes, or 10 minutes. The range of the discovery message covers at least the area 420. The discovery message may comprise information indicating the presence of the implantable medical device 200 and / or information necessary for establishing a communication channel. In addition, or alternatively, the discovery message may comprise an identification of the implantable medical device 200, for example a serial number. In some embodiments, the discovery message further comprises the date of the last reception of a data request message and / or the last date when a medical data set has been sent to a local communication unit 100.

[0078] The means for receiving 110 may receive the discovery message from the implantable medical device 200. The means for receiving 110 may be configured to scan for the discovery message of the implantable medical device 200. In some embodiments, the scanning for the discovery signal may be steered and / or scheduled by the central communication unit 300. Upon the means for receiving 110 receiving the discovery signal, the means for transmitting 120 may transmit a data request message to the implantable medical device 200. In general, the local communication unit 100 may read the discovery message and store the identification, e.g., the serial number, of the implantable medical device 200. The data request message may comprise predefined and / or programmed parameters and may further comprise parameters that depend on the discovery message. Furthermore, the data request message may be associated with the identification of the implantable medical device.

[0079] Associating the identification of the implantable medical device 200 with the data request message and / or storing the identification on the local communication unit 100, e.g., on a storage medium comprised by the local communication unit 100, may allow the local communication unit 100 to track and / or to count the number of request messages sent to the implantable medical device 200. In particular, the number of request messages sent to the implantable medical device 200 may be bound by an upper limit within a certain time interval. For example, the request message may be sent at most once within a time interval of one day. In other implementations, the request message may be sent at most once within a time interval of six hours, three hours, or one hour. In general, the time interval and / or the threshold may depend on the type of the implantable medical device 200 and / or the discovery message.

[0080] Bounding the number of request messages which are sent to the implantable medical device 200 within a time interval may ensure that the implantable medical device 200 is not inquired to prepare and / or to generate and / or to measure the medical data set more often than said threshold within said time interval. This minimizes the probability of an unnecessary inquiry of the implantable medical device 200 by the local communication unit 100, maximizes the new content of the medical data set compared to the medical data set sent in response to the last inquiry and thus optimizes the use of the energy resources of the implantable medical device 200. In addition, or alternatively, the local communication unit 100 may transmit a command for establishing a connection to the implantable medical device 200 after receiving the discovery message and before transmitting the data request message. In this case, the implantable medical device 200 and the local communication unit may establish a communication channel for a communication session. After establishing said channel, the data request message may be sent to the implantable medical device 200.

[0081] The implantable medical device 200 receives the data request message from the local communication unit by virtue of the means for receiving 220. For example, the implantable medical device 200 may receive the data request message via the established (local wireless) communication channel. In response to receiving the data request message, the implantable medical device 200 may prepare and / or generate the medical data set. In general, generating the medical data set may comprise measuring physical properties. The physical properties can be properties of the implantable medical device 200 and / or of the corresponding patient. For example, a physical property of the implantable medical device 200 may be a battery voltage. The physical properties of the corresponding patient may depend on the type of the implant and / or the data request message. Conducting measurements of the physical properties may be triggered by the data request message, i.e., the measurement is performed in response to receiving the data request message. In general, preparing and / or generating the medical data set may further comprise to load and / or to read medical data stored on the implantable medical device 200, e.g., on a storage medium comprised by the implantable medical device 200. The medical data stored on the implantable medical device 200 may be medical data that has been generated in the past, i.e., before receiving the data request message. The medical data set may comprise medical data that has been generated before and / or after receiving the data request signal. The medical data set is sent by virtue of the means for transmitting 230 to the local communication unit 100. For example, the medical data set may be sent via the same communication channel which was used for communicating the data request message.

[0082] The local communication unit 100 receives the medical data set via the communication channel from the implantable medical device 200 via the means for receiving 130. In response to receiving the medical data set the local communication unit 100 may forward the medical data set via a network to a central communication unit 300 by virtue of the means for transmitting 140. In addition, or alternatively, the local communication unit 100 may process the received medical data set before transmitting the medical data set to the central communication unit 300. The processing may comprise changing the format of the medical data set, adding and / or removing data, decoding and / or encoding the medical data set, and / or encrypting the medical data set. For example, the processing may add the identification of the implantable medical device 100 to the medical data set. In general, the network may comprise WPAN, WLAN, WWAN, GAN and / or general cellular networks as GSM, PCS, LTE and / or 5G.

[0083] The central communication unit 300 receives the medical data set from the local communication unit 100 via the network by virtue of the means for receiving 310. The central communication unit may further process the received medical data using the means for processing 330. The processing may comprise an unpacking and / or a decoding and / or a decryption of the medical data set (the implantable device 100 and / or the local communication unit 200 may comprise corresponding means for packing, encoding and / or encrypting). In addition, or alternatively, central communication unit 300 may perform a reading of the identification of the implantable medical device 200, when the identification is comprised in the medical data set. The central communication unit may further comprise means for verifying 340 whether the implantable medical device 200 is registered with the central communication unit 300. For example, the means for verifying may compare the identification of the implantable medical device 200 with a list of deposited identifications of a plurality of implantable medical devices that may be stored at or be accessible by the central communication unit. If the identification is comprised in the list, the means for verifying may regard the implantable medical device 200 as registered.

[0084] The central communication unit may be configured such that the means for processing 330 the medical data process the medical data set if the implantable medical device 200 is a registered. In addition, or alternatively, the means for transmitting 320 the indication is configured to transmit the indication, if the implantable medical device 200 is a registered and / or if the means for processing 330 have processed the data.

[0085] The indication is configured to indicate the availability of the received medical data set to an authorized user 410. The indication may further information based on the identification of the implantable medical device 200. Including this information to the indication may allow the authorized user to infer the implantable medical device and / or the corresponding patient. In general, indicating the availability of medical data and / or the information to the authorized user provides an automatic interrogation of the medical data set of the implantable medical device 200. This optimizes the workflow and reduces the time expenditure. In other embodiments, the indication may further comprise at least a part of the medical data set. The indication is transmitted to the authorized user 410 via the means for transmitting 330 the indication. In general, the authorized user 410 may be located within a treatment area 430. For example, the treatment area 430 may be a doctor’s office and / or a hospital. The authorized person may receive the indication. In response to receiving the indication the authorized user 410 may access the medical data set stored on the central communication unit for analysis. In addition, or alternatively, the authorized user may send a request message to the central communication unit 300 for accessing the medical data set. The central communication unit may verify the authorized user 410 and may sent the medical data set via a network to the authorized user 410.

Claims

Claims1. A local communication unit (100) adapted for communication with a plurality of implantable medical devices (200) comprising: means for receiving (110) a discovery message from an implantable medical device (200) via a local wireless communication; means for transmitting (120) a data request message to the implantable medical device (200) via the local wireless communication upon receiving the discovery message; means for receiving (130) a medical data set from the implantable medical device (200) via the local wireless communication upon transmitting the data request message.

2. The local communication unit (100) according to claim 1, further comprising means for transmitting (140) data to a central communication unit (300) for processing, preferably wherein the transmitted data is at least partially based on the received medical data set.

3. The local communication unit (100) according to one of the claims 1 or 2, wherein the number of data request messages transmitted to the implantable medical device (200) via the local wireless communication in a time interval is bound by an upper limit; wherein the upper limit preferably comprises at most one request message transmitted to the implantable medical device (200) within an hour, more preferably at most one request message transmitted to the implantable medical device (200) within a day.

4. The local communication unit (100) according to one of the claims 1 to 3, wherein the data request message is associated with an identification of the implantable medical device (200), preferably wherein the identification comprises a serial number of the implantable medical device (200).

5. The local communication unit (100) according to claim 4, wherein the number of request messages transmitted to the implantable medical device (200) is based on the identification of the implantable medical device (200).

6. The local communication unit (100) according to one of the claims 1 to 5, wherein the local communication unit (100) is configured to transmit the data request message to the implantable medical device (200) based on the discovery message; and / or wherein themeans for receiving is configured to scan for discovery messages, preferably by cyclic scanning.

7. An implantable medical device (200) adapted for communication with a local communication unit (100) comprising: means for transmitting (210) a discovery message via a local wireless communication; means for receiving (220) a data request message from the local communication unit via the local wireless communication upon transmitting the discovery message; means for transmitting (230) a medical data set to the local communication unit via the local wireless communication upon receiving the data request message.

8. The local communication unit (100) according to any of claims 1 to 6 or the implantable medical device (100) according to claim 7, wherein the medical data set comprises one or more current after-care records and / or wherein the medical data set is based on the data request message.

9. The local communication unit (100) or the implantable medical device (200) according to claim 8, wherein at least a part of the current after-care records is based on medical data which is generated and / or measured after the data request message is received by the implantable medical device (200).

10. The implantable medical device (200) according to one of the claims 7 to 9, wherein the means for transmitting (230) the medical data set is configured to transmit the medical data set within a time period starting from the receipt of the data request message bounded by a threshold; preferably wherein the threshold is at most 30 minutes, more preferably at most 20 minutes, even more preferably at most 10 minutes, most preferably at most 5 minutes; and / or wherein the threshold is based on the data request message.

11. The implantable medical device (200) according to one of the claims 7 to 10, wherein the implantable medical device (200) is configured to transmit the discovery message in a pattern, preferably a periodic pattern, most preferably wherein the discovery message is transmitted with a period of at most 10 minutes, at most 5 minutes, or at most 1 minute.

12. A central communication unit (300) adapted for communication with a local communication unit (100), the central communication unit (300) comprising: means for receiving (310) a medical data set from the local communication unit; means for transmitting (320) an indication of an availability of the received medical data set to an authorized user (410); wherein the indication further indicates an implantable medical device (200) which provided the medical data set.

13. The central communication system (300) according to claim 12, further comprising means for processing (330) the received medical data set, in particular means for decoding the received medical data set.

14. The central communication unit (300) according to claim 12 or 13, further comprising means for verifying (340) whether the implantable medical device (200) is registered with the central communication unit (300), and / or wherein preferably the means for transmitting (320) the indication is configured to transmit the indication, if the implantable medical device (200) is registered.

15. A system (400) comprising at least two of the following: a local communication unit (100) according to one of the claims 1 to 6, an implantable medical device (200) according to one of the claims 7 to 11, or a central communication unit (300) according to one of the claims 12 to 14.

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