Non-cardiovascular implantable electronic device (CIED) interface

The system integrates and converts data from implantable and non-implantable devices, addressing limitations in remote patient monitoring by enabling comprehensive data analysis and improved patient care.

WO2025252516A1PCT designated stage Publication Date: 2025-12-11BIOTRONIK SE & CO KG
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Patent Information

Application Number
PCT/EP2025/064482
Authority / Receiving Office
WO · WO
Patent Type
Applications
Current Assignee / Owner
Priority Date
2024-06-06
Filing Date
2025-05-26
Publication Date
2025-12-11

AI Technical Summary

Technical Problem

Current remote patient monitoring systems are limited to patients with implants and lack the ability to integrate various medical data from different sources, failing to utilize clinically relevant algorithms for patients without implants and lacking a centralized data access point.

Method used

A system that integrates medical data from both implantable and non-implantable devices by converting data formats using interfaces and conversion means, allowing for unified storage, analysis, and processing of diverse medical data.

Benefits of technology

Enables comprehensive patient monitoring by integrating data from both implantable and non-implantable devices, enhancing diagnosis, patient care, and fitness tracking, and providing a more complete health picture.

✦ Generated by Eureka AI based on patent content.

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Abstract

A system for remote patient monitoring comprises: a first interface for receiving first medical data in a first data format from at least one implantable medical device of at least one first patient, a second interface for receiving second medical data in a second data format from at least one non-implantable medical device, and a conversion means configured to convert the second medical data into the first data format.
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Description

[0001] Applicant: BIOTRONIK SE & Co. KG

[0002] Date: 26.05.2025

[0003] Our Reference: 24.059P-WO

[0004] Non-Cardiovascular Implantable Electronic Device (CIED) Interface

[0005] The present invention relates, inter alia, to systems for remote patient monitoring as well as corresponding methods and computer programs.

[0006] Patient monitoring systems for collecting and integrating implant data from implantable medical devices exist and pose a promising platform for the collection of electronic and remotely accessible patient data.

[0007] One disadvantage of known solutions is the limited use of the remote patient monitoring systems limited to patients who already have an implant, although many clinically relevant algorithms of the remote patient monitoring systems could also be used for patients without an active implant. Furthermore, the patient history that led to the indication for implantation of an active implant cannot be stored here and used for follow-up remote patient monitoring.

[0008] Another disadvantage results from the fact that current solutions lack capabilities to integrate various inputs, e.g., medial data from various sources within the same system / database. Therefore, currently mostly isolated systems exist. However, their communication and the availability of the various data in a central access point is yet to be optimized.

[0009] Therefore, there is still a need to further optimize systems for remote patient monitoring as well as corresponding methods and computer programs.

[0010] The aspects of the present invention meet the above need at least in part. A first aspect of the present invention relates to a system for remote patient monitoring. The system comprises a first interface for receiving first medical data in a first data format from at least one implantable medical device of at least one first patient, a second interface for receiving second medical data in a second data format from at least one nonimplantable medical device, and a conversion means configured to convert the second medical data into the first data format.

[0011] Advantageously, data that would normally be recorded in typical implantable medical devices can be derived from the second medical data (e.g., external diagnostic data) using the conversion means. This allows the converted medical data to be stored in the “implant format” (i.e., the first data format), e.g., medical data on heart rate variability, maximum and minimum heart rate (at rest and during exercise) from external ECG data, patient activity from fitness trackers, and / or thoracic impedance from fitness chest belts. These examples already illustrate the wider variety of medical data that can be integrated. Consequently, this opens a wide field of opportunities, comprising, e.g., improved diagnosis, improved patient care, improved fitness tracking for improved training and (athletic) performance, etc.

[0012] For example, the first and second interface may be comprised by separate devices, e.g., and / or be configured to receive the respective medical data via relay devices. E.g., for a first patient, the first medical data may be routed via a first relay device, e.g., a mobile device like a smart phone, which may be coupled to one or more implantable medical devices of the first patient. Another patient may, e.g., transmit its (second) medical data via a second relay device, e.g., a mobile device like a smart phone, which may be coupled to one or more non-implantable medical devices of the second patient.

[0013] In other examples, the same (relay) device may provide the first and second medical data to the first and second interface, respectively. E.g., a further exemplary patient may have one or more implantable and one or more non-implantable medical devices. In this example, both, the first and the second medical data therefrom may be routed via a common relay device, e.g., a mobile device like a smart phone, which may be coupled to one or more implantable medical devices and to one or more non-implantable medical devices of the exemplary patient.

[0014] In some examples, the first and / or second interface may, e.g., be an interface of a remote server comprised in the remote patient monitoring system, e.g., an interface for connecting said server to a network via which the first and / or second medical data may be received, e.g., the internet.

[0015] Generally, the interface may, e.g., configured for, e.g., wirelessly, receiving (medical) data. Therefore, the first and / or second interface may, e.g., operate based on a corresponding protocol, hardware component, and / or software, e.g., adapted to facilitate communication between devices. The first and / or second interface may include one or more antennas and / or one or more receivers for capturing (e.g., wireless) signals comprising at least a part of the first and / or second medical data, e.g., via protocols like Wi-Fi for data transmission.

[0016] The remote patient monitoring system may, e.g., be an (e.g., distributed) system comprising a plurality of devices or may comprise only one device (e.g., a server or a cloud-based server) and its means may, e.g., be implemented as components thereof.

[0017] The system may, e.g., comprise a third interface for receiving third medical data in a third data format from at least one implantable medical device. The conversion means may, e.g., be configured to convert the third medical data into the first data format.

[0018] In some examples, the conversion may comprise a down-sampling, an up-sampling, preferably comprising an interpolation, and / or a quantization, preferably comprising a rounding.

[0019] With these functionalities, a simple yet efficient conversion may be allowed which may increase the system’s efficiency.

[0020] For example, when the second data format has a higher data rate (e.g., 1000 Hz) than the first data format (e.g., 256 Hz), the second medical data may be down-sampled to 256 Hz to match the first data format in this aspect. This is a typical situation that may occur because implantable medical devices may be optimized, e.g., by means of low data rates, in order increase battery lifetimes, such that down-sampling may be a suitable approach.

[0021] Interpolation may, e.g., be a valuable approach that may be applied when the data rate of the second medical data is lower than that of the first medical data.

[0022] Quantization, e.g., by means of rounding may decrease the required storage capacities, e.g., by reducing the number of digits by rounding. This may further simplify any further data processing of such quantized medical data.

[0023] In some examples, the data format may comprise a (data) rate, a range, a label, a timestamp, and / or an event marker. In some examples, the data format may comprise a data resolution, an image coding, a data coding and / or a data compression.

[0024] These aspects of the data format may allow to unify, e.g., the first and second medical data such that they may be stored, processed, analyzed, and / or treated the same way. This may simplify such functionalities due to the use of unified input data.

[0025] The first and / or second medical data may, e.g., comprise one or more (x,y) datapoints, wherein x may denote a point in time, and y may denote a recorded quantity relating to a medical measure. In one example, y(x) may express a neurostimulation intensity y over time x.

[0026] The (data) rate may, e.g., be a measure for the (average) distance Ax = xn+i - xnbetween two subsequent data points (xn,yn) and (xn+i,yn+i) at times xnand xn+i, respectively. It may, e.g., also relate to and / or be expressed as 1 / Ax and / or a measure proportional thereto.

[0027] The range may, e.g., relate to a minimum (ymin) and maximum (ymax) value of y, i.e., defining the range [ymin, ymax]. Therein, the y-values do not necessarily have to span the full range (but may do so in some examples). Rather, they may only be required to lie therein. The label may, e.g., relate to whether the medical data originate from an implantable or non-implantable medical device.

[0028] The timestamp (format) may relate to a format in which a time(stamp), e.g., the x-value described herein, may be present in the first and / or second medical data described herein. It may, e.g., to save storage, be in a numeric format that is based on only indexing medical data when knowing the Ax between two subsequent data points (xn,yn) and (xn+i,yn+i).

[0029] The event marker may, e.g., They lead to whether the medical data comprise a marker or not. The system may, e.g., also comprise means for assigning such marker and / or means for finding such marker within the first and or second medical data.

[0030] In some examples, the data format may comprise a data representation. For example, the data representation of the data format of the non-implantable medical device may define that data is represented in a table form, whereas the data representation of the data format of the implantable medical device may define that data is represented without table form, or vice versa. For example, the data representation of the data format of the non- implantable medical device may define that data is represented in a calculated manner (e.g., 20 m / s), whereas the data representation of the data format of the implantable medical device may define that data is represented in an individual manner (e.g., 40 m / 2 s), or vice versa.

[0031] In some examples, the implantable medical device may comprise an electrocardiograph, ECG, device, a rhythm monitor, an impedance sensor for recording thoracic impedances, a blood pressure sensor, a heart failure sensor, a pressure sensor, a respiratory sensor, and / or a neurostimulator, preferably a spinal cord stimulator and / or the non-implantable medical device may comprise an ECG, an external rhythm monitor, an impedance sensor for recording thoracic impedances, a blood pressure sensor, a heart failure sensor, a pressure sensor, a respiratory sensor, and / or a neurostimulator, preferably a spinal cord stimulator. These examples are particularly suitable for acquiring the first and / or second medical data described herein. Thereby, efficient remote patient monitoring may be achieved.

[0032] A non-implantable ECG device may, e.g., comprise an ECG recorder, a long-term ECG, an exercise ECG, a Holter ECG, and / or a fitness and / or medical ECG

[0033] In some examples, the at least one non-implantable medical device may comprise a trial device, wherein preferably the trial device may be configured to emulate at least a part of the functionalities of an implantable medical device.

[0034] Integrating such trial devices into remote patient monitoring systems may be particularly advantageous as it allows to integrate pre-implantation medical data (in this example: corresponding to the second medical data) such that the full patient journey may be analyzed by attending health professionals and / or other people involved in the (remote) patient monitoring.

[0035] The trial device may be a wearable device which may be worn by the patient for a limited period of time in order to test the suitability of that patient for an implantable medical device under consideration and / or to test which exact implantable medical device may be suitable for said patient.

[0036] In some examples, the at least one non-implantable medical device may comprise a non- implantable medical device of at least one second patient and / or an interface to input second medical data of the at least one second patient.

[0037] Thereby, the variety of medical data that may be integrated into the remote patient monitoring system may be significantly increased as medical data from non-implant patients may be integrated, on the one hand, via non-implantable medical devices and, on the other hand, via input, e.g., manual input by an attending health professional, e.g., via a computer, a mobile device, a website, an online portal, etc. of the remote patient monitoring system. In some examples, the second patient may comprise a patient without an implantable medical device.

[0038] Thereby, the system may allow to also integrate patients without an implantable medical device which may allow them to benefit from the various advantages of remote patient monitoring despite not having an implant.

[0039] In some examples, the at least one non-implantable medical device may comprise a wearable device.

[0040] Wearable devices may be particularly advantageous due to their easy use, high comfort, and widespread acceptance by patients.

[0041] In some examples, the system may further comprise a means for labelling the converted second medical data as non-implantable medical device data.

[0042] In some examples, the system may further comprise an analysis means configured to provide an analysis which may, e.g., be based on a comparison of first medical data and the converted second medical data and / or may be based on the first medical data and the converted second medical data.

[0043] Basing the analysis on both, the first and the second medical data may allow to obtain a more complete picture of the actual health state of the patient which may increase efficiency, and applicability of the system described herein.

[0044] The analysis may, e.g., comprise comparing a first monitored parameter yf,i (i = 1, ..., n) comprised in the first medical data and a second monitored parameter ys,j (j = 1, ..., m) comprised in the second medical data, wherein the first and second monitored parameter may measure the same medical parameter of the patient, e.g., blood pressure, neurostimulation intensity. E.g., the analysis may, comprise a comparison of two averages: A first average (e.g., S =a37,i / (^— awith 0 < a < b < n) of the first medical parameter (e.g., in the example of the medical device providing the first medical data comprising the first monitored parameter being an implanted neurostimulator) may, e.g., be the average neurostimulation intensity chosen by the patient (e.g., via a user device) in a predetermined time period after implantation. A second respective average (e.g.,lj<=cys,j / .d- ~c)> with 0 < c < d < m) of the second medical parameter (e.g., in the example of the medical device providing the second medical data comprising the first monitored parameter being a wearable, non-implantable neurostimulator trial device) may, e.g., be the average neurostimulation intensity chosen by the patient (e.g., via a user device) during a predetermined time period before implantation and when wearing the neurostimulator trial device. This exemplary analysis (e.g., comparison) may, e.g., allow to monitor the acceptance of the patient of the implanted neurostimulator and / or allow to take any countermeasures if said analysis indicates any issue.

[0045] While this illustrative example shows the general advantages of analyses based on the first medical data and the converted second medical data (which may not be possible based on non-converted second medical data and / or without any second medical data at all), more complex analyses may be performed as well.

[0046] E.g., the system described herein may further comprise an alert means configured to provide an alert, preferably based at least partly on the second medical data and / or based at least partly on the comparison described herein. An alert may, e.g., be provided when a certain medical data value (and / or a change thereof) exceeds a certain value, or a similar event occurs.

[0047] In some examples, the system may further comprise a storing means for storing the first medical data and the second medical data. Preferably, the system may, e.g., further comprise a third interface for accessing the storing means by a plurality of remote users.

[0048] The storing means may, e.g., comprise a database, which may, e.g., be located at a remote location and / or may be distributed to a plurality of locations. Advantageously,

[0049] In some examples, the system may further comprise a processing means configured to apply at least one predetermined analysis function adapted to the first data format, wherein optionally the processing means may further be configured to apply the at least one predetermined analysis function to the second medical data and, optionally, to the first medical data.

[0050] Thereby, the remote patient monitoring system may be equipped (alterably) with analysis function adapted to the first data format while at the same time, any (possible yet unknown) further non-implantable medical device or implantable or medical device may be coupled to the system in a way that their medical data may be analyzed with said analysis function(s). This increases the reliability, flexibility, and user satisfaction.

[0051] In some examples, the system may further comprise a selection means configured to select, out of the received second medical data, a part of the second medical data based on the data format of the part of the second medical data.

[0052] In some examples, the second medical data may, e.g., comprise a plurality of parameters, herein also called channels. For example, an implantable or non-implantable neurostimulator may record an electrical activity (e.g., electrical signals generated by neurons in the brain or nervous system recorded to monitor brain activity or to detect abnormal patterns indicative of conditions like epilepsy), stimulation settings (e.g., parameters related to the stimulation settings such as frequency, amplitude / intensity, pulse width, and / or duration), battery status, temperature, and / or an activity log (e.g., information about when the device was active, duration of stimulation sessions, and / or any triggered events or alarms).

[0053] In an example, in which the first medical data comprise stimulation settings, but the second medical data comprise all of the above examples, the selection means may select, out of the received second medical data, the part of the second medical data the stimulation settings (and optionally discard all or at least a part of the other channels) as thereby, consistent first and second converted medical data may be obtained. E.g., if no exact match of the channels of the first and second data may exist, the selection may, e.g., be based on a best match between the first medical data and a part of the second medical data. Thus, the selection may be based on the data format of the part of the second medical data. An example of this selection is, e.g., described herein in reference to Fig. 3.

[0054] A second aspect of the present invention relates to a method for remote patient monitoring. The method comprises: receiving, by a first interface, first medical data in a first data format from at least one implantable medical device of at least one first patient, receiving, by a second interface, second medical data in a second data format from at least one nonimplantable medical device, and converting, by a conversion means, the second medical data into the first data format.

[0055] A third aspect of the present invention relates to a computer program comprising instructions for executing the steps of the method as described herein when the instructions are executed.

[0056] The method and the computer program essentially achieve the advantages described herein in reference to the system. Any means of the system and / or any functionality described in reference thereto may be implemented as a step of the method according to the second aspect and / or as an instruction of the computer program according to the third aspect, and vice versa.

[0057] 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.

[0058] For example, the one or more computers can be configured to be suitable for the execution of a computer program and can include, by way of example, both general and special purpose microprocessors, and any one or more processors of any kind of digital computer. 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, e.g., EPROM, EEPROM, flash storage devices, and solid state drives; magnetic disks, e.g., internal hard disks or removable disks; magneto-optical disks; and CD-ROM, DVD-ROM, and / or Blu-ray discs.

[0059] In some implementations, the systems, interfaces, means, and / or servers described herein can include a data processor and a storage device. The data processor can e.g., execute the functionalities of the system described herein. The storage device can store e.g., the first and / or second medical data. In some implementations, the systems, interfaces, means, and / or servers described herein can include one or more computers that include one or more data processors configured to execute one or more programs that include a plurality of instructions according to the principles described above. 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 millions or billions of transistors.

[0060] The processing of data described in this document, such as described herein, can be carried out using one or more computers, which can include 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. The one or more computers can include one or more input devices, such as a keyboard, a mouse, a touchpad, and / or a voice command input module, and one or more output devices, such as a display, and / or an audio speaker. In some implementations, the one or more computing devices can include digital electronic circuitry, computer hardware, firmware, software, or any combination of the above. The features related to processing of data can be implemented in a computer program product tangibly embodied in an information carrier, e.g., in a machine-readable storage device, for execution by a programmable processor; and method steps can be performed by a programmable processor executing a program of instructions to perform functions of the described implementations. Alternatively or in addition, the program instructions can be encoded on a propagated signal that is an artificially generated signal, e.g., a machinegenerated electrical, optical, or electromagnetic signal, that is generated to encode information for transmission to suitable receiver apparatus for execution by a programmable processor.

[0061] In some implementations, the processes described above can be implemented using software for execution on one or more mobile computing devices, one or more local computing devices, and / or one or more remote computing devices (which can be, e.g., cloud computing devices). For instance, the software forms procedures in one or more computer programs that execute on one or more programmed or programmable computer systems, either in the mobile computing devices, local computing devices, or remote computing systems (which may be of various architectures such as distributed, client / server, grid, or cloud), each including at least one processor, at least one data storage system (including volatile and non-volatile memory and / or storage elements), at least one wired or wireless input device or port, and at least one wired or wireless output device or port.

[0062] In some implementations, the software may be provided on a medium, such as CD-ROM, DVD-ROM, Blu-ray disc, a solid state drive, or a hard drive, readable by a general or special purpose programmable computer or delivered (encoded in a propagated signal) over a network to the computer where it is executed. The functions can be performed on a special purpose computer, or using special-purpose hardware, such as coprocessors. The software can be implemented in a distributed manner in which different parts of the computation specified by the software are performed by different computers. Each such computer program is preferably stored on or downloaded to a storage media or device (e.g., solid state memory or media, or magnetic or optical media) readable by a general or special purpose programmable computer, for configuring and operating the computer when the storage media or device is read by the computer system to perform the procedures described herein. The inventive system can also be considered to be implemented as a computer-readable storage medium, configured with a computer program, where the storage medium so configured causes a computer system to operate in a specific and predefined manner to perform the functions described herein.

[0063] The embodiments of the present invention that are described in this specification and the optional features and properties respectively mentioned in this regard should also be understood to be disclosed in all combinations with one another. In particular, in the present case, the description of a feature comprised by an embodiment - unless explicitly explained to the contrary - should also not be understood such that the feature is essential or indispensable for the function of the embodiment.

[0064] Fig. 1 shows an exemplary system for remote patient monitoring.

[0065] Fig. 2 shows an exemplary conversion of medical data from a one data format into another.

[0066] Fig. 3 shows an analysis of medical data comprising an extraction and a conversion of episode data.

[0067] Fig. 1 shows an exemplary system 100 for remote patient monitoring.

[0068] Said system 100 receives first medical data 111 from at least one implantable medical device 110 of at least one patient via a relay device, e.g., a patient device 120 like, e.g., a smartphone, which is transmitted to a central server 140 via a first interface 130. Data can also be sent from the central server 140 via the first interface 130 and the patient device 120 to the implantable medical device 110 in order to reconfigure it or request data. In the example of Fig. 1, a user device 160, e.g., a clinical user device, wherein the (clinical) user may, e.g., be an attending health professional, is bidirectionally connected to the central server 140 via a second interface 150 and can thus receive data 151 and request evaluations or data or implant reconfigurations and / or can input further medical data 161.

[0069] In addition, in the example of Fig. 1, a further interface 180 is available according to the invention described herein, which can receive medical data 171 from non-implantable medical device(s) 170 and convert these according to the invention into another data format, e.g., one that corresponds to the data formats of the medical data 171 from the implantable medical device(s) 110.

[0070] Thus, data from patients without an implantable medical device 110 can now also be processed in the patient monitoring system 100, e.g., by the central server 140, and made accessible to the user device 160.

[0071] The central server 140, may, in the example of Fig. 1 be a stationary server, a cloud-based server, and / or a plurality of servers. The central server 140 may, e.g., be configured to process the medical data 111, 161, 171 it receives as described herein. The central server 140 may, e.g., comprise storage means / a database for storing the (medical) data 111, 161, 171 described herein.

[0072] For example, the medical data 111 described herein, e.g., in reference to Fig. 1, could be data from rhythm sensors 110 that support the indication for implantation of a CRM system (pacemaker, defibrillator, CRT, etc.). Medical data 171 from external sensors 170 can also be integrated to support the monitoring of heart failure, which was previously only possible with data from implants. Examples of the conversion of data formats in the interface 180 and / or in the central server 140 may comprise: resampling and scaling (e.g., of ECG signals), adaptation of (e.g., arrhythmia episode) medical data, scaling and resampling of medical data (e.g., medical data from impedance measurements), and / or scaling and threshold adjustments of medical data (e.g., accelerometer data). Fig. 2 shows an exemplary conversion 200 of medical data 171 from a non-implantable medical device (not shown in Fig. 2) from one data format into another. The exemplary medical data 171, as illustrated, e.g., in Fig. 2, may comprise a plurality of channels - in Fig. 2 called I, II, III, aVR, aVL, aVF, and VI.

[0073] As a first step of the conversion 200, in optional step 210, one of the plurality of channels, i.e., a part of the medical data 171 may be selected. This may, e.g., be based on the data format of the part of the medical data 171, e.g., by assessing which of the channels / parts of the medical data 171 matches best with the medical data from an implantable medical device (not shown in Fig. 2). E.g., said match may be based on a (e.g., highest or abovethreshold) degree of similarity of the data formats of the medical data 171 from the non- implantable medical device.

[0074] Each channel of the medical data 171 comprises a plurality of (x,y)-data, wherein x denotes the position on the x-axis (e.g., a time) and y the corresponding amplitude. In step 220, in the example of Fig. 2, a resampling of the amplitude (x,y)-data is performed, e.g., expressed through the function y = resample(x, p, q) from 1000 Hz to 256 Hz. In this example, the medical data are acquired at a rate of 1000 Hz and thus down-sampled to a rate of 256 Hz, which may, e.g., correspond to the corresponding medical data rate of the medical data from an implantable medical device (not shown).

[0075] In (optional) step 230, the resampled medical data may, e.g., be further processed as a part of the conversion 200 by applying a bandpass filter to the resampled data (e.g., as per step 220). Said further processing may, e.g., be expressed through the function y = bandpass(x, Wpass). Step 230 may thus adjust the amplitude range. In the third step 230, the digital ECG filter of the implant may thus be simulated and then the amplitude range of the resulting, filtered ECG signal may be scaled to the permissible amplitude range of a corresponding implantable ECG, e.g., so that no clipping of the signal can occur.

[0076] In (optional) step 240, one or more event markers may be detected in the medical data, e.g., QRS markers in the example of ECG medical data. The so-called QRS complex is a waveform that represents the depolarization of the ventricles, which is the electrical activity that precedes their contraction. Q, R, and S are specific points within this complex waveform: The Q wave is the first downward deflection after the P wave, representing depolarization of the interventricular septum. The R wave is the first upward deflection after the P wave, indicating depolarization of the main mass of the ventricles. The S wave is the downward deflection that follows the R wave, marking the completion of ventricular depolarization. These Q, R, and S points may serve as markers to assess the timing and duration of ventricular depolarization, aiding in the diagnosis of various cardiac conditions. For instance, abnormalities in the QRS complex can indicate heart rhythm disturbances, conduction abnormalities, or other cardiac issues. For said QRS detection, a QRS detection of a corresponding implantable medical device is simulated in software and the individual cardiac actions are marked and measured so that the same information is available in the ECG display and further processing in the implant remote monitoring system as from a corresponding implantable medical device.

[0077] Finally, said steps 210, 220, 230, 240 of the conversion 200 may yield the converted medical data 250, e.g., at a converted rate, a converted amplitude, and with or without the detected markers. The entire ECG data stream 250 may then be stored in the ECG format of the corresponding implantable medical device (i.e., in this example an ECG), including marker information and data compression, in the remote patient monitoring system, e.g., marked as a pseudo-implant (e.g.: labelled as “implant type: external sensor”) and / or, e.g., with a generated unique serial number / identification.

[0078] Fig. 3 shows an analysis 300 of medical data 171 (illustrated herein by the graphs 301) comprising an extraction and conversion of episode data. In detail, Fig. 3 may apply to an example of the extraction and conversion of episode data from a long-term ECG recording 171 into the format used by the remote monitoring system for episode data processing.

[0079] For this purpose, the event annotation in the long-term ECG 171 (cf. event markers 302) is first used and in a first step 310 the event time and the event end are determined, and the event type may be read out. In a table created, e.g., by a converter 310, the event type may be assigned to the event markers available in the remote implant follow-up system (e.g.: a high atrial rate event may be labelled as “Afib”, cf. table 330). Additional events in the long-term ECG data can also be determined by the converter 310 (e.g., comprising detection of a high ventricular rate with the usual threshold value of an implant algorithm).

[0080] In the additional unit 320, the ECG sections assigned to the events are “cut out” from the long-term ECG and may, e.g., be processed according to Figure 2 and then assigned to the implant episode list as an episode ECG and stored.

[0081] In general, the analysis 300 may, e.g., yield a result like the table 330. The exemplary table 330 of Fig. 3 comprises an event number (“No.” = 1, 2, 3, ...) a start date (“Start”) and an end date (“End”) specifying when said event occurred, a description (e.g., “Afib” indicating a high atrial rate event or “High Ventricular Rate” indicating a corresponding event), and a link to the, e.g., as-analyzed medical data and / or unprocessed and / or only partly processed medical data. (Episode) data can be viewed in the remote patient monitoring system (cf. e.g., Fig. 1) and the associated ECG data can be accessed via the “Link: ECG” in table 330. This may, e.g., be used to call up the associated ECG sections.

Claims

Claims1. System (100) for remote patient monitoring, comprising: a first interface for receiving first medical data (111) in a first data format from at least one implantable medical device (110) of at least one first patient; a second interface for receiving second medical data (171) in a second data format from at least one non-implantable medical device (170); and a conversion means configured to convert the second medical data (171) into the first data format.

2. The system (100) of claim 1, wherein the conversion comprises a down-sampling, an up-sampling, preferably comprising an interpolation, and / or a quantization, preferably comprising a rounding.

3. The system (100) of claim 1 or 2, wherein data format comprises a rate, a range, a label, a timestamp, and / or an event marker.

4. The system (100) of any of the previous claims, wherein the implantable medical device (110) comprises a rhythm monitor, an impedance sensor for recording thoracic impedances, a blood pressure sensor, a heart failure sensor, a pressure sensor, a respiratory sensor, and / or a neurostimulator, preferably a spinal cord stimulator; and / or wherein the non-implantable medical device (170) comprises an electrocardiogram, ECG, device, an external rhythm monitor, an impedance sensor for recording thoracic impedances, a blood pressure sensor, a heart failure sensor, a pressure sensor, a respiratory sensor, and / or a neurostimulator, preferably a spinal cord stimulator.

5. The system (100) of any of the previous claims, wherein the at least one non- implantable medical device (170) comprises a trial device, wherein preferably the trial device is configured to emulate at least a part of the functionalities of an implantable medical device (110).

6. The system (100) of any of the previous claims, wherein the at least one nonimplantable medical device (170) comprises a non-implantable medical device (170) of at least one second patient and / or an interface to input second medical data (171) of the at least one second patient.

7. The system (100) of claim 6, wherein the second patient comprises a patient without an implantable medical device (110).

8. The system (100) of any of the previous claims, wherein the at least one non- implantable medical device (170) comprises a wearable device.

9. The system (100) of any of the previous claims, further comprising a means for labelling the converted second medical data (171) as non-implantable medical device (170) data.

10. The system (100) of any of the previous claims, further comprising an analysis means configured to provide an analysis based on a comparison of first medical data (111) and the converted second medical data (171).

11. The system (100) of any of the previous claims, further comprising a storing means for storing the first medical data (111) and the second medical data (171); and preferably further comprising a third interface for accessing the storing means by a plurality of remote users.

12. The system (100) of any of the previous claims, further comprising a processing means configured to apply at least one predetermined analysis function adapted to the first data format; wherein optionally the processing means is further configured to apply the at least one predetermined analysis function to the first medical data (111) and the second medical data (171).

13. The system (100) of any of the previous claims, further comprising a selection means configured to select, out of the received second medical data (171), a part of the second medical data (171) based on the data format of the part of the second medical data (171).

14. Method for remote patient monitoring, comprising: receiving, by a first interface, first medical data (111) in a first data format from at least one implantable medical device (110) of at least one first patient; receiving, by a second interface, second medical data (171) in a second data format from at least one non-implantable medical device (170); and converting, by a conversion means, the second medical data (171) into the first data format.

15. Computer program comprising instructions for executing the steps of the method of claim 14 when the instructions are executed.

Citation Information

Patent Citations

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