Implant communication system and registration method

The implant communication system automates the registration of implantable medical devices using unique identifiers and authentication factors, improving efficiency and security in telemedicine applications.

WO2026012664A1PCT designated stage Publication Date: 2026-01-15BIOTRONIK SE & CO KG
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Patent Information

Application Number
PCT/EP2025/066197
Authority / Receiving Office
WO · WO
Patent Type
Applications
Current Assignee / Owner
Priority Date
2024-07-30
Filing Date
2025-06-11
Publication Date
2026-01-15

AI Technical Summary

Technical Problem

The registration of implantable medical devices for telemedicine applications is manually intensive and lacks data security, allowing unauthorized access and inefficient user registration.

Method used

An implant communication system and method that automates the registration process using a unique identifier and authentication factor, integrating with existing wireless data transmission capabilities to ensure secure and efficient enrollment of devices within authorized user groups.

Benefits of technology

Automated registration reduces manual effort by up to 30 minutes per device, enhances data security, and ensures only authorized users access patient data by verifying device integrity and location.

✦ Generated by Eureka AI based on patent content.

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Abstract

The invention relates to an implant communication system (1) for registration of an implantable medical device (IMD, 10) for telemedicine applications, comprising an IMD (10), a remote server (12), in particular a cloud-server, of a telemedicine applications provider, and an implant communication device (14a, 14b) configured to wirelessly communicate with the IMD (10) and the remote server (12) of the telemedicine applications provider, wherein the IMD (10) is configured to detect implantation and generate a registration message (16) comprising a unique identifier (18) of the IMD (10) and a further authentication factor (20) configured to verify an integrity of the unique identifier (18) and / or the registration message (16) of the IMD (10), wherein the registration message (16) is transmitted via the implant communication device (14a, 14b) to the remote server (12) of the telemedicine applications provider. In addition, the invention relates to a computer- implemented method for registration of an IMD (10) for telemedicine applications.
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Description

[0001] Implant communication system and registration method

[0002] The invention relates to an implant communication system for registration of an implantable medical device for telemedicine applications.

[0003] The invention further relates to a computer-implemented method for registration of an implantable medical device for telemedicine applications.

[0004] Conventionally, the registration of an implantable medical device suitable for telemedicine applications with a service center of a vendor or telemedicine applications provider is performed manually in a time intensive manner.

[0005] The registration information is entered by medical personnel via the website of the vendor service center or telemedicine applications provider.

[0006] Furthermore, a user can potentially register any implant by knowing or guessing the implant serial number, even if he or she is not the treating physician.

[0007] It is therefore an object of the present invention to provide an improved implant communication system and method for registration of an implantable medical device for telemedicine applications that provides improved efficiency and enhanced data security.

[0008] The object is solved by an implant communication system having the features of claim 1.

[0009] Furthermore, the object is solved by a computer-implemented method for registration of an implantable medical device for telemedicine applications having the features of claim 11. Furthermore, the object is solved by a computer program having the features of claim 14 and by a computer-readable data carrier having the features of claim 15.

[0010] Further developments and advantageous embodiments are defined in the dependent claims.

[0011] The present invention provides an implant communication system for registration of an implantable medical device (IMD) for telemedicine applications.

[0012] The implant communication system comprises an implantable medical device, a remote server, in particular a cloud-server, of a telemedicine applications provider, and an implant communication device configured to wirelessly communicate with the implantable medical device and the remote server of the telemedicine applications provider.

[0013] The implantable medical device is configured to detect implantation and generate a registration message comprising a unique identifier of the implantable medical device and a further authentication factor configured to verify an integrity of the unique identifier and / or the registration message of the implantable medical device.

[0014] Furthermore, the registration message is transmitted via the implant communication device to the remote server of the telemedicine applications provider.

[0015] Moreover, the present invention provides a computer-implemented method for registration of an implantable medical device for telemedicine applications.

[0016] The method comprises providing an implantable medical device, providing a remote server, in particular a cloud-server, of a telemedicine applications provider and providing an implant communication device wirelessly communicating with the implantable medical device and the remote server of the telemedicine applications provider.

[0017] In addition, the method comprises detecting implantation and generating a registration message comprising a unique identifier of the implantable medical device and a further

[0018] 24.038P-WO / 11.06.2025 authentication factor verifying an integrity of the unique identifier and / or the registration message of the implantable medical device by the implantable medical device.

[0019] Furthermore, the method comprises transmitting the registration message via the implant communication device to the remote server of the telemedicine applications provider.

[0020] Moreover, the present invention provides a computer program with program code to perform the methods of the present invention when the computer program is executed on a computer. In addition, the present invention provides a computer-readable data carrier containing program code of a computer program for performing the methods of the present invention when the computer program is executed on a computer.

[0021] An idea of the present invention is to provide an implant communication system for registration of an implantable medical device for telemedicine applications, wherein after implantation, implantable devices get automatically registered at a service center of a vendor or telemedicine applications provider within the corresponding user group.

[0022] The registration within a specific user group is necessary to ensure that only authorized users have access to the patients’ data.

[0023] The manual implant registration process in the service center of the vendor or telemedicine applications provider by medical personnel is thus eliminated. Typically, manual registration with PID takes 10 minutes if the user is already logged into the service center of the vendor or telemedicine applications provider. If there is no reason to use the service center other than patient registration, the total time saved for the user could be 30 minutes or more.

[0024] Moreover, the process for registration of the implantable medical device with the service center of the vendor or telemedicine applications provider is advantageously integrated into the automatic data transfer capability of the implantable medical device. The fact that the implantable medical device is configured to regularly transmit measurement data to the implant communication device and further to the remote server is used in this context to automate the registration process by using the same methods and infrastructure than is

[0025] 24.038P-WO / 11.06.2025 customarily used for transmitting patient medical data to the backend server via the implant communication device.

[0026] According to an aspect of the invention, the unique identifier of the implantable medical device is a serial number and the further authentication factor is a checksum. The second authentication factor hence advantageously provides a means to ensure the correct serial number is being transmitted to and registered at the service center.

[0027] According to a further aspect of the invention, the implantable medical device is configured to transmit the registration message to the implant communication device, in particular a relay device, via Bluetooth or MIC S -band communication.

[0028] The implantable medical device is thus able to use its functionality of a wireless data transmission in order to transmit the registration message to the implant communication device, preferably directly, after implantation has been detected.

[0029] According to a further aspect of the invention, the implant communication device, in particular a programming device, is configured to interrogate the implantable medical device, wherein the implantable medical device is configured to transmit the registration message to the implant communication device via near-fi eld-communication.

[0030] According to this alternative embodiment, the implantable medical device is capable of transmitting the registration message to the programming device, e.g. during the implantation procedure.

[0031] According to a further aspect of the invention, the implant communication device, in particular the relay device, is configured to detect implantation of the implantable medical device by receiving the registration message from the implantable medical device, or wherein the implant communication device, in particular the programming device, is configured to detect implantation of the implantable medical device by being actively involved in an implantation procedure.

[0032] 24.038P-WO / 11.06.2025 The implantable medical device is thus advantageously capable of communicating with various implant communication devices in order to transmit the registration message for registration at the vendor service center or server of the telemedicine applications provider.

[0033] According to a further aspect of the invention, the implant communication device is configured to forward the registration message along with an identifier of the implant communication device to the remote server of the telemedicine applications provider.

[0034] Transmitting the identifier of the implant communication device to the remote server of the telemedicine applications provider advantageously enables the registration of the implantable medical device to the corresponding user group, e.g. a clinic or hospital to which the implant communication device is assigned.

[0035] According to a further aspect of the invention, the remote server of the telemedicine applications provider is configured to look up a user group of the implant communication device based on the identifier received from the implant communication device and to register the implantable medical device to said user group.

[0036] This advantageously enables a seamless and efficient registration process of the implantable medical device at the remote server of the telemedicine applications provider.

[0037] According to a further aspect of the invention, the remote server of the telemedicine applications provider is configured to associate a mobile network cell ID local to the user groups’ location with the implant communication device.

[0038] This advantageously provides an additional layer of security by keeping track of a mobile network cell ID local to the user groups’ location which can in turn be used to enable further safety measures.

[0039] According to a further aspect of the invention, the remote server of the telemedicine applications provider is configured to discard a message received from the implant communication device that does not originate from the mobile network cell ID local to the

[0040] 24.038P-WO / 11.06.2025 user groups’ location or fails an attestation check. This ensures that only implant communication devices meeting the defined requirements are able to send valid messages to the remote server.

[0041] According to a further aspect of the invention, the remote server of the telemedicine applications provider is configured to generate a warning message to at least one user of the user group if a message is received that does not originate from the mobile network cell ID local to the user groups’ location or fails the attestation check. In this way, appropriate action by the user can be taken to rectify the situation.

[0042] According to a further aspect of the invention, the implant communication device is registered with a user group by an authorized user of the telemedicine applications provider prior to implantation of the implantable medical device. That way it is made sure that implantable medical devices are registered to the correct user group via the implant communication device that has been preregistered by the authorized user to said particular user group.

[0043] According to a further aspect of the invention, during a registration process of the implant communication device, an attestation check is performed on the implant communication device, wherein the implant communication device comprises an electronically stored signature representing a hardware and software configuration of the implant communication device, and wherein a validity of said electronically stored signature is checked.

[0044] The electronically stored signature thus advantageously ensures that the correct implant communication device is used for registering the implantable medical device to the remote server of the telemedicine applications provider.

[0045] The herein described features of the implant communication system for registration of an implantable medical device for telemedicine applications are also disclosed for the computer-implemented method for registration of an implantable medical device for telemedicine applications and vice versa.

[0046] 24.038P-WO / 11.06.2025 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:

[0047] Fig. 1 shows a diagram of an implant communication system according to a preferred embodiment of the invention; and

[0048] Fig. 2 shows a flowchart of a computer-implemented method for registration of an implantable medical device for telemedicine applications according to the preferred embodiment of the invention.

[0049] The implant communication system 1 for registration of an implantable medical device 10 for telemedicine applications, comprises an implantable medical device 10, a remote server 12, in particular a cloud-server, of a telemedicine applications provider, and an implant communication device 14a, 14b configured to wirelessly communicate with the implantable medical device 10 and the remote server 12 of the telemedicine applications provider.

[0050] Furthermore, the implantable medical device 10 is configured to detect implantation and generate a registration message 16 comprising a unique identifier 18 of the implantable medical device 10 and a further authentication factor 20 configured to verify an integrity of the unique identifier 18 and / or the registration message 16 of the implantable medical device 10.

[0051] Moreover, the registration message 16 is transmitted via the implant communication device 14a, 14b to the remote server 12 of the telemedicine applications provider.

[0052] The unique identifier 18 of the implantable medical device 10 is a serial number and the further authentication factor 20 is a checksum. In addition, the implantable medical device 10 is configured to transmit the registration message 16 to the implant communication device 14a, 14b, in particular a relay device 14a, via Bluetooth or MICS-band communication.

[0053] 24.038P-WO / 11.06.2025 The implant communication device 14a, 14b, in particular a programming device 14b, is configured to interrogate the implantable medical device 10, wherein the implantable medical device 10 is configured to transmit the registration message 16 to the implant communication device 14a, 14b via near-fi eld-communication.

[0054] Furthermore, the implant communication device 14a, 14b, in particular the relay device 14a, is configured to detect implantation of the implantable medical device 10 by receiving the registration message 16 from the implantable medical device 10, or wherein the implant communication device 14a, 14b, in particular the programming device 14b, is configured to detect implantation of the implantable medical device 10 by being actively involved in an implantation procedure.

[0055] The implant communication device 14a, 14b moreover is configured to forward the registration message 16 along with an identifier 22 of the implant communication device 14a, 14b to the remote server 12 of the telemedicine applications provider.

[0056] The remote server 12 of the telemedicine applications provider is configured to look up a user group 24 of the implant communication device 14a, 14b based on the identifier 22 received from the implant communication device 14a, 14b and to register the implantable medical device 10 to said user group 24. In addition, the remote server 12 of the telemedicine applications provider is configured to associate a mobile network cell ID 26 local to the user groups’ location with the implant communication device 14a, 14b.

[0057] The remote server 12 of the telemedicine applications provider is further configured to discard a message received from the implant communication device 14a, 14b that does not originate from the mobile network cell ID 26 local to the user groups’ location or fails an attestation check 28. In addition, the remote server 12 of the telemedicine applications provider is configured to generate a warning message to at least one user of the user group 24 if a message is received that does not originate from the mobile network cell ID 26 local to the user groups’ location or fails the attestation check 28.

[0058] 24.038P-WO / 11.06.2025 Fig. 2 shows a flowchart of a computer-implemented method for registration of an implantable medical device 10 for telemedicine applications according to the preferred embodiment of the invention.

[0059] The method comprises providing SI an implantable medical device 10, providing S2 a remote server 12, in particular a cloud-server, of a telemedicine applications provider and providing S3 an implant communication device 14a, 14b wirelessly communicating with the implantable medical device 10 and the remote server 12 of the telemedicine applications provider.

[0060] The method in addition comprises detecting S4a, S4b implantation and generating a registration message 16 comprising a unique identifier 18 of the implantable medical device 10 and a further authentication factor 20 verifying an integrity of the unique identifier 18 and / or the registration message 16 of the implantable medical device 10 by the implantable medical device 10.

[0061] Moreover, the method comprises transmitting S5 the registration message 16 via the implant communication device 14a, 14b to the remote server 12 of the telemedicine applications provider.

[0062] The unique identifier 18 of the implantable medical device 10 is a serial number and the further authentication factor 20 is a checksum. In addition, the implantable medical device 10 transmits the registration message 16 to the implant communication device 14a, 14b, in particular a relay device 14a, via Bluetooth or MICS-band communication.

[0063] The implant communication device 14a, 14b, in particular a programming device 14b interrogates the implantable medical device 10, wherein the implantable medical device 10 transmits the registration message 16 to the implant communication device 14a, 14b via near-fi el d-communi cati on .

[0064] Furthermore, the implant communication device 14a, 14b, in particular the relay device 14a, detects implantation of the implantable medical device 10 by receiving the registration

[0065] 24.038P-WO / 11.06.2025 message 16 from the implantable medical device 10, or wherein the implant communication device 14a, 14b, in particular the programming device 14b detects implantation of the implantable medical device 10 by being actively involved in an implantation procedure.

[0066] Furthermore, the implant communication device 14a, 14b is registered with a user group 24 by an authorized user of the telemedicine applications provider prior to implantation of the implantable medical device 10.

[0067] During a registration process of the implant communication device 14a, 14b, an attestation check 28 is performed on the implant communication device 14a, 14b, wherein the implant communication device 14a, 14b comprises an electronically stored signature 30 representing a hardware and software configuration of the implant communication device 14a, 14b, and wherein a validity of said electronically stored signature 30 is checked.

[0068] Although specific embodiments have been illustrated and described herein, it will be understood by those skilled in the art that a variety of alternative and / or equivalent implementations exist. It should be noted that the exemplary embodiment or exemplary embodiments are examples only and are not intended to limit the scope, applicability or configuration in any way.

[0069] Rather, the foregoing detailed description provides the skilled person with a convenient guide to implementing at least one exemplary embodiment, it being understood that various changes in the scope of functionality and arrangement of the elements may be made without departing from the scope of the appended claims and their legal equivalents.

[0070] In general, this application intends to cover modifications or adaptations or variations of the embodiments disclosed herein. For example, a sequence of method steps may be modified. The method may further be carried out sequentially or in parallel, at least in part.

[0071] 24.038P-WO / 11.06.2025 Reference Signs

[0072] 1 implant communication system

[0073] 10 implantable medical device 12 remote server

[0074] 14a, 14b implant communication device

[0075] 16 registration message

[0076] 18 unique identifier

[0077] 20 further authentication factor 22 identifier

[0078] 24 user group

[0079] 26 mobile network cell ID

[0080] 28 attestation check

[0081] 30 electronically stored signature

[0082] 24.038P-WO / 11.06.2025

Claims

Claims1. Implant communication system (1) for registration of an implantable medical device (10) for telemedicine applications, comprising: an implantable medical device (10); a remote server (12), in particular a cloud-server, of a telemedicine applications provider; and an implant communication device (14a, 14b) configured to wirelessly communicate with the implantable medical device (10) and the remote server (12) of the telemedicine applications provider, wherein the implantable medical device (10) is configured to detect implantation and generate a registration message (16) comprising a unique identifier (18) of the implantable medical device (10) and a further authentication factor (20) configured to verify an integrity of the unique identifier (18) and / or the registration message (16) of the implantable medical device (10), wherein the registration message (16) is transmitted via the implant communication device (14a, 14b) to the remote server (12) of the telemedicine applications provider.

2. Implant communication system of claim 1, wherein the unique identifier (18) of the implantable medical device (10) is a serial number and the further authentication factor (20) is a checksum.

3. Implant communication system of claim 1 or 2, wherein the implantable medical device (10) is configured to transmit the registration message (16) to the implant communication device (14a), in particular a relay device (14a), via Bluetooth or MICS- band communication.

4. Implant communication system of claim 1 or 2, wherein the implant communication device (14b), in particular a programming device (14b), is configured to interrogate the implantable medical device (10), wherein the implantable medical device (10) is configured to transmit the registration message (16) to the implant communication device (14b) via near-fi eld-communication.24.038P-WO / 11.06.20255. Implant communication system of claim 3 or 4, wherein the implant communication device (14a), in particular the relay device (14a), is configured to detect implantation of the implantable medical device (10) by receiving the registration message (16) from the implantable medical device (10), or wherein the implant communication device (14b), in particular the programming device (14b), is configured to detect implantation of the implantable medical device (10) by being actively involved in an implantation procedure.

6. Implant communication system of any one of the preceding claims, wherein the implant communication device (14a, 14b) is configured to forward the registration message (16) along with an identifier (22) of the implant communication device (14a, 14b) to the remote server (12) of the telemedicine applications provider.

7. Implant communication system of claim 6, wherein the remote server (12) of the telemedicine applications provider is configured to look up a user group (24) of the implant communication device (14a, 14b) based on the identifier (22) received from the implant communication device (14a, 14b) and to register the implantable medical device (10) to said user group (24).

8. Implant communication system of any one of the preceding claims, wherein the remote server (12) of the telemedicine applications provider is configured to associate a mobile network cell ID (26) local to the user groups’ location with the implant communication device (14a, 14b).

9. Implant communication system of claim 8, wherein the remote server (12) of the telemedicine applications provider is configured to discard a message received from the implant communication device (14a, 14b) that does not originate from the mobile network cell ID (26) local to the user groups’ location or fails an attestation check (28).

10. Implant communication system of claim 9, wherein the remote server (12) of the telemedicine applications provider is configured to generate a warning message to at least one user of the user group (24) if a message is received that does not originate24.038P-WO / 11.06.2025from the mobile network cell ID (26) local to the user groups’ location or fails the attestation check (28).

11. Computer-implemented method for registration of an implantable medical device (10) for telemedicine applications, comprising the steps of: providing (SI) an implantable medical device (10); providing (S2) a remote server (12), in particular a cloud-server, of a telemedicine applications provider; providing (S3) an implant communication device (14a, 14b) wirelessly communicating with the implantable medical device (10) and the remote server (12) of the telemedicine applications provider; detecting (S4a, S4b) implantation and generating a registration message (16) comprising a unique identifier (18) of the implantable medical device (10) and a further authentication factor (20) verifying an integrity of the unique identifier (18) and / or the registration message (16) of the implantable medical device (10) by the implantable medical device (10); and transmitting (S5) the registration message (16) via the implant communication device (14a, 14b) to the remote server (12) of the telemedicine applications provider.

12. Computer-implemented method of claim 11, wherein the implant communication device (14a, 14b) is registered with a user group (24) by an authorized user of the telemedicine applications provider prior to implantation of the implantable medical device (10).

13. Computer-implemented method of claim 11 or 12, wherein during a registration process of the implant communication device (14a, 14b), an attestation check (28) is performed on the implant communication device (14a, 14b), wherein the implant communication device (14a, 14b) comprises an electronically stored signature (30) representing a hardware and software configuration of the implant communication device (14a, 14b), and wherein a validity of said electronically stored signature (30) is checked.24.038P-WO / 11.06.202514. Computer program with program code to perform the method of any one of claims 1 to 10 when the computer program is executed on a computer.

15. Computer-readable data carrier containing program code of a computer program for performing the method of any one of claims 1 to 10 when the computer program is executed on a computer.24.038P-WO / 11.06.2025