Medical device, medical device system and method for operating a medical device system

Abstract

The invention relates to a medical device, in particular implantable medical device or medical device for use outside of the human body configured to receive and / or capture medical data (D), comprising a determining means (12) configured to estimate a service life of the medical device (10a; 10b) by evaluating at least one medical device parameter (P) of the medical device (10a; 10b) and / or reading out a pre-programmed value (14). Furthermore, the invention relates to a medical device system (1), comprising a first medical device (10a), wherein the first medical device (10a) is an implantable medical device, and at least one second medical device (10b), wherein the at least one second medical device (10b) is an implantable medical device or a medical device for use outside of the human body configured to receive and / or capture medical data (D), wherein the first medical device (10a) and the at least one second medical device (10b) are a medical device according to the present invention. In addition, the invention relates to a computer-implemented method for operating a medical device system.

Description

[0001] Medical device, medical device system and method for operating a medical device system

[0002] The invention relates to a medical device, in particular implantable medical device or medical device for use outside of the human body configured to receive and / or capture medical data. Furthermore, the invention relates to a medical device system.

[0003] Moreover, the invention relates to a computer-implemented method for operating a medical device system.

[0004] Technical offers of medical technology for the healing of ailments are intended for use with the human body. Over time, this approach gave rise to the need for clear and strict legal regulation of medical technology research and development.

[0005] Regulation (EU) 2017 / 745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017 on medical devices, amending Directive 2001 / 83 / EC, Regulation (EC) No 178 / 2002 and Regulation (EC) No 1223 / 2009 and repealing Council Directives 90 / 385ZEEC and 93 / 42ZEEC known as Medical Device Regulation or MDR clearly and strictly regulates, among other things, the lifetime of medical devices.

[0006] The MDR requires with regard to the service life of products that risk management shall be understood as a continuous iterative process throughout the life cycle of a device, which requires regular systematic updating.

[0007] A prerequisite for understanding the life cycle of a product is a dynamic knowledge of the service life or service life forecast. In the future, manufacturers will only be in a position to implement the contents of the MDR once they have knowledge of the service life. In implementing risk management, manufacturers must define and document a risk management plan for each product, identify and analyze the known and foreseeable hazards associated with each product, and assess and evaluate the risks associated with the intended use.

[0008] The MDR also requires that the characteristics and performance of the device must not be compromised to the extent that the health or safety of the patient or user or, where applicable, third parties is endangered during the lifetime of the device, when the device is subjected to stresses likely to occur under normal conditions of use and has been properly maintained in accordance with the manufacturer's instructions.

[0009] In the future, manufacturers will therefore be in a position to determine the characteristics and their performance dynamically for each product in order to meet the requirements of the MDR.

[0010] Device networks comprising one or more active electronic implants face the challenge of providing a communication compatibly and security over a very long product life cycle, in some cases up to 30 years. Physical component reliability / lifetime, e.g., different times of battery exhaustion as well as the compatibility of communication protocols represent a complexity to be managed.

[0011] The present invention furthermore provides a medical device system. The system comprises a first medical device, wherein the first medical device is an implantable medical device.

[0012] Moreover, the system comprises at least one second medical device, wherein the at least one second medical device is an implantable medical device or a medical device for use outside of the human body configured to receive and / or capture medical data, wherein the first medical device and the at least one second medical device are a medical device according to the present invention.

[0013] 22.197P-WO / 30.08.2024 In addition, the present invention furthermore provides a computer-implemented method for operating a medical device system. The method comprises providing a first medical device, wherein the first medical device is an implantable medical device.

[0014] The method furthermore comprises providing at least one second medical device. Moreover, the method comprises receiving and / or capturing medical data by the at least one second medical device, wherein the at least one second medical device is an implantable medical device or a medical device for use outside of the human body.

[0015] Furthermore, the method comprises exchanging respective service life data between the first medical device and the at least one second medical device in order to determine a service life of the medical device system.

[0016] In addition, the present invention provides a computer program with program code to perform the method of the present invention when the computer program is executed on a computer.

[0017] An idea of the present invention is thus to allow the management of complex device systems with multiple implants in order to monitor and control its runtime-determining influencing variables over the entire product life cycle.

[0018] According to an aspect of the invention, the determining means is configured to apply a machine learning algorithm to the at least one medical device parameter of the medical device, wherein the machine learning algorithm is configured to output at least one value representing the service life of the medical device.

[0019] The determining means is thus advantageously able to estimate a service life of the medical device by evaluating at least one medical device parameter of the medical device by applying said machine learning algorithm to the at least one medical device parameter of the medical device thus being able to identify nonlinear relationships and / or functions between the at least one medical device parameter of the medical device and the service life of the medical device.

[0020] 22.197P-WO / 30.08.2024 According to a further aspect of the invention, the medical device parameter is at least one of a state of charge of a battery of the medical device, a communication technology, in particular a communication protocol, of the medical device, and data of an error memory of the medical device. Said parameters thus advantageously serve to predict the service life of the medical device.

[0021] According to a further aspect of the invention, the medical device comprises a plurality of components, wherein the service life of the medical device is determined to be a service life of the component of the medical device having the shortest service life.

[0022] By determining the specific component having the shortest service life within the medical device it is possible to extend the service life of the medical device by replacing the identified component and / or power source of the component.

[0023] According to a further aspect of the invention, the component of the medical device is at least one of a primary battery, a secondary battery, electronic components, electrode leads, a drug depot, a high voltage capacitor, a body contact material, a standard based communication protocol, a corrosive element and a mechanical element.

[0024] By being able to identify the specific component, a cause of failure of the medical device can be determined such that the component can be redesigned and improved in order to enhance the service life of the medical device in future versions of said medical device.

[0025] According to a further aspect of the invention, the medical device is one of an IPG, an ICD, a CRT-P / D, a rhythm monitor, a neurostimulator, a medication pump, a VAD and a sensor implant.

[0026] The concept of the present invention is thus applicable to a broad range of medical devices allowing for a prediction of the service life of said medical devices across a complete product range of the manufacturer.

[0027] 22.197P-WO / 30.08.2024 According to a further aspect of the invention, the first medical device and the at least one second medical device are configured to exchange respective service life data in order to determine a service life of the medical device system.

[0028] By exchanging the respective service life data said first medical device and the at least one second medical device enables to determine which of said devices of the overall system has the shortest service life.

[0029] According to a further aspect of the invention, the determining means of the first medical device and / or the at least one second medical device is configured to determine the service life of the medical device system as a lifetime of the medical device with the shortest service life. Said determination allows for a replacement and / or redesign of the respective medical device and / or component of the medical device.

[0030] According to a further aspect of the invention, the medical device system comprises at least one medical device for use outside of the human body configured to receive and / or capture medical data. Said medical device for use outside of the human body can e.g. be given by a patient communication device such as a smart phone or tablet computing device connectable to specific medical sensors.

[0031] According to a further aspect of the invention, the medical device system is configured to signal an end of the service life of the first medical device and / or the at least one second medical device, in particular a predetermined duration prior to the end of the service life, to a medical information system, in particular a data server, of a health service provider.

[0032] By receiving said information prior to the end of the service life, a predictive maintenance action may be triggered repairing or replacing a specific medical device and / or component of the medical device which results in an uninterrupted service of the medical device system.

[0033] According to a further aspect of the invention, the determining means of the first medical device and / or the at least one second medical device is configured to determine an expiration of a communication technology, in particular a communication protocol, used by the first

[0034] 22.197P-WO / 30.08.2024 medical device and / or the at least one second medical device. Obtaining this information thus enables to provide a software update to the specific medical device having a communication technology that is about to expire.

[0035] According to a further aspect of the invention, the medical device system is configured to request and install updates of the communication technology, in particular the communication protocol, used by the first medical device and / or the at least one second medical device upon detection of the expiration of the communication technology.

[0036] This predictive maintenance action is advantageously triggered automatically such that no manual supervision of the respective communication technology of said medical devices is required.

[0037] The herein described features of the medical device and system are also disclosed for the computer-implemented method for operating a medical device system and vice versa.

[0038] 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:

[0039] Fig. 1 shows a diagram of a medical device according to a preferred embodiment of the invention;

[0040] Fig. 2 shows a diagram of a medical device system according to the preferred embodiment of the invention; and

[0041] Fig. 3 shows a flowchart of a computer-implemented method for operating a medical device system according to the preferred embodiment of the invention.

[0042] 22.197P-WO / 30.08.2024 The medical device, in particular an implantable medical device or a medical device for use outside of the human body configured to receive and / or capture medical data D shown in Fig. 1 comprises a determining means 12 configured to estimate a service life of the medical device 10a; 10b by evaluating at least one medical device parameter P of the medical device 10a; 10b and / or reading out a pre-programmed value 14 of the medical device 10a; 10b representing the service life of the medical device 10a; 10b.

[0043] The determining means 12 is configured to apply a machine learning algorithm A to the at least one medical device parameter P of the medical device 10a; 10b, wherein the machine learning algorithm A is configured to output at least one value 16 representing the service life of the medical device 10a; 10b.

[0044] Furthermore, the medical device parameter P is at least one of a state of charge of a battery of the medical device 10a; 10b, a communication technology, in particular a communication protocol, of the medical device 10a; 10b, and data of an error memory of the medical device 10a; 10b.

[0045] The medical device moreover comprises a plurality of components 18, wherein the service life of the medical device 10a; 10b is determined to be a service life of the component 18 of the medical device 10a; 10b having the shortest service life.

[0046] The component 18 of the medical device 10a; 10b is at least one of a primary battery, a secondary battery, electronic components, electrode leads, a drug depot, a high voltage capacitor, a body contact material, a standard based communication protocol, a corrosive element and a mechanical element. The medical device is one of an IPG, an ICD, a CRT- P / D, a rhythm monitor, a neurostimulator, a medication pump, a VAD and a sensor implant.

[0047] Fig. 2 shows a diagram of a medical device system 1 according to the preferred embodiment of the invention.

[0048] The medical device system 1 comprises a first medical device 10a, wherein the first medical device 10a is an implantable medical device, wherein the medical device system 1 further

[0049] 22.197P-WO / 30.08.2024 comprises at least one second medical device 10b, wherein the at least one second medical device 10b is an implantable medical device or a medical device for use outside of the human body configured to receive and / or capture medical data D, wherein the first medical device 10a and the at least one second medical device 10b are a medical device described in Fig. 1.

[0050] The first medical device 10a and the at least one second medical device 10b are configured to exchange respective service life data in order to determine a service life of the medical device system 1.

[0051] Furthermore, the determining means 12 of the first medical device 10a and / or the at least one second medical device 10b is configured to determine the service life of the medical device system 1 as a lifetime of the medical device 10a; 10b with the shortest service life.

[0052] The medical device system 1 moreover comprises at least one medical device for use outside of the human body configured to receive and / or capture medical data D.

[0053] In addition, the medical device system 1 is configured to signal an end of the service life of the first medical device 10a and / or the at least one second medical device 10b, in particular a predetermined duration prior to the end of the service life, to a medical information system 20, in particular a data server, of a health service provider.

[0054] The determining means 12 of the first medical device 10a and / or the at least one second medical device 10b is further configured to determine an expiration of a communication technology, in particular a communication protocol, used by the first medical device 10a and / or the at least one second medical device 10b.

[0055] Moreover, the medical device system 1 is configured to request and install updates of the communication technology, in particular the communication protocol, used by the first medical device 10a and / or the at least one second medical device 10b upon detection of the expiration of the communication technology.

[0056] 22.197P-WO / 30.08.2024 According to the preferred embodiment, the medical device system 1 comprises an S-ICD, iLP, a patient communication device such as a smart phone as patient relay and a connection to a medical information system 20, in particular a data server, of a health service provider.

[0057] Alternatively, the medical device can e.g., be an IPG, a CRT-P / D, a rhythm monitor, a neurostimulator, a medication pump, a VAD and / or a sensor implant.

[0058] According to the preferred embodiment, the S-ICD and the iLP exchange data on battery remaining time, communication standards used, and the error memory.

[0059] Service life information, in addition to implant clinical data, is transmitted e.g., via a Bluetooth Low Energy BLE protocol to the patient communication device and from there to the medical information system 20, in particular the data server, of the health service provider.

[0060] Additionally, the patient communication device transmits its hardware and software status. In addition to clinical data, the medical information system 20, in particular the data server, of the health service provider further evaluates information on battery runtimes, communication protocols, and error memories.

[0061] Moreover, the medical information system 20, in particular the data server, of the health service provider furthermore evaluates meta-information on the communication protocol used between the implantable medical device and the patient communication device so that the medical information system 20 can, for example, "predict" that with the next software or hardware update of the patient communication device, the communication interface to the implantable medical device will become incompatible and signals and / or initiates a firmware update of at least one of the implants to update the communication protocol for future transmission.

[0062] Fig. 3 shows a flowchart of a computer-implemented method for operating a medical device system according to the preferred embodiment of the invention.

[0063] 22.197P-WO / 30.08.2024 The method comprises the steps of providing SI a first medical device 10a, wherein the first medical device 10a is an implantable medical device and providing S2 at least one second medical device 10b, wherein the at least one second medical device 10b is an implantable medical device or a medical device for use outside of the human body configured to receive S3 and / or capture medical data D, wherein the first medical device 10a and the at least one second medical device 10b exchange S4 respective service life data in order to determine a service life of the medical device system 1.

[0064] 22.197P-WO / 30.08.2024 Reference Signs

[0065] 1 medical device system

[0066] 10a, 10b medical device 12 determining means

[0067] 14 pre-programmed value

[0068] 16 value

[0069] 18 component

[0070] 20 medical information system A machine learning algorithm

[0071] D medical data

[0072] P medical device parameter

[0073] SI - S4 method steps

[0074] 22.197P-WO / 30.08.2024

Claims

Claims1. Medical device (10a; 10b), in particular implantable medical device or medical device for use outside of the human body configured to receive and / or capture medical data (D), comprising a determining means (12) configured to estimate a service life of the medical device (10a; 10b) by evaluating at least one medical device parameter (P) of the medical device (10a; 10b) and / or reading out a pre-programmed value (14) of the medical device (10a; 10b) representing the service life of the medical device (10a; 10b).

2. Medical device of claim 1, wherein the determining means (12) is configured to apply a machine learning algorithm (A) to the at least one medical device parameter (P) of the medical device (10a; 10b), wherein the machine learning algorithm (A) is configured to output at least one value (16) representing the service life of the medical device (10a; 10b).

3. Medical device of claim 1 or 2, wherein the medical device parameter (P) is at least one of a state of charge of a battery of the medical device (10a; 10b), a communication technology, in particular a communication protocol, of the medical device (10a; 10b), and data of an error memory of the medical device (10a; 10b).

4. Medical device of any one of the preceding claims, wherein the medical device (10a; 10b) comprises a plurality of components (18), wherein the service life of the medical device (10a; 10b) is determined to be a service life of the component (18) of the medical device (10a; 10b) having the shortest service life.

5. Medical device of claim 4, wherein the component (18) of the medical device (10a; 10b) is at least one of a primary battery, a secondary battery, electronic components, electrode leads, a drug depot, a high voltage capacitor, a body contact material, a standard based communication protocol, a corrosive element and a mechanical element.22.197P-WO / 30.08.20246. Medical device of any one of the preceding claims, wherein the medical device (10a; 10b) is one of an IPG, an ICD, a CRT-P / D, a rhythm monitor, a neurostimulator, a medication pump, a VAD and a sensor implant.

7. Medical device system (1), comprising: a first medical device (10a), wherein the first medical device (10a) is an implantable medical device; and at least one second medical device (10b), wherein the at least one second medical device (10b) is an implantable medical device or a medical device for use outside of the human body configured to receive and / or capture medical data (D), wherein the first medical device (10a) and the at least one second medical device (10b) are a medical device (10a; 10b) having the features of any one of claims 1 to 6.

8. Medical device system of claim 7, wherein the first medical device (10a) and the at least one second medical device (10b) are configured to exchange respective service life data in order to determine a service life of the medical device system (1).

9. Medical device system of claim 7 or 8, wherein the determining means (12) of the first medical device (10a) and / or the at least one second medical device (10b) is configured to determine the service life of the medical device (10a; 10b) system as a lifetime of the medical device (10a; 10b) with the shortest service life.

10. Medical device system of any one of claims 7 to 9, wherein the medical device system (1) comprises at least one medical device for use outside of the human body configured to receive and / or capture medical data (D).

11. Medical device system of any one of claims 7 to 10, wherein the medical device system (1) is configured to signal an end of the service life of the first medical device (10a) and / or the at least one second medical device (10b), in particular a predetermined duration prior to the end of the service life, to a medical information system (20), in particular a data server, of a health service provider.22.197P-WO / 30.08.202412. Medical device system of any one of claims 7 to 11, wherein the determining means (12) of the first medical device (10a) and / or the at least one second medical device (10b) is configured to determine an expiration of a communication technology, in particular a communication protocol, used by the first medical device (10a) and / or the at least one second medical device (10b).

13. Medical device system of claim 12, wherein the medical device system (1) is configured to request and install updates of the communication technology, in particular the communication protocol, used by the first medical device (10a) and / or the at least one second medical device (10b) upon detection of the expiration of the communication technology.

14. Computer-implemented method for operating a medical device system (1), the method comprising the steps of: providing (SI) a first medical device (10a), wherein the first medical device (10a) is an implantable medical device; providing (S2) at least one second medical device (10b), receiving (S3) and / or capturing medical data (D) by the at least one second medical device (10b), wherein the at least one second medical device (10b) is an implantable medical device or a medical device for use outside of the human body; and exchanging (S4) respective service life data between the first medical device (10a) and the at least one second medical device (10b) in order to determine a service life of the medical device (10a; 10b) system.

15. Computer program with program code to perform the method of claim 14 when the computer program is executed on a computer.22.197P-WO / 30.08.2024

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