AU2024238265A1 - System and method for high-reliability transmission of data from remote source for use in reimbursement documentation - Google Patents

Abstract

An apparatus for transmitting data to and/or receiving data from an implantable medical device is described, comprising means for regularly transmitting data to and/or regularly receiving data from the implantable medical device, means for detecting an irregularity in transmitting and/or receiving data, and means for providing an alert based on the irregularity.

Description

SYSTEM AND METHOD FOR HIGH-RELIABILITY TRANSMISSION OF DATA FROM REMOTE SOURCE FOR USE IN REIMBURSEMENT DOCUMENTATION

The invention relates to devices, systems, methods, and computer programs for remote programming of medical devices and/or data transmission from and/or to medical devices.

State-of-the-art implantable pacemakers, cardiac monitors, neurostimulation (NS) devices and other implantable medical devices (IMDs) communicate with clinician user interface devices (“programmers”) during a face-to-face visit with a clinician. During the face-to-face visit, the programmer provides a real-time view of diagnostic and technical data.

Frequently, IMDs are also able to transmit diagnostic and technical data periodically to a server, e.g., a remote monitoring server (RMS). Clinicians may then access this data through a secure website. This enables them to check the data log transmitted to the RMS to remotely monitor and track their patients. Such data log yields an overview of the past, and potentially recent, health history of the respective patient.

However, as in known solutions the implantable devices typically transmit based only upon an internal trigger (e.g., event detection, scheduled update transmission) or patient trigger, the frequency of transmission usually will not meet the medical standards required for sufficient remote patient monitoring. For example, at present the Center for Medicare (CMS) Current Procedural Terminology (CPT®) codes require 16/30 days of data to be reported for a patient for that period to be sufficient for the attending clinician, who relies on uninterrupted data transmission from the respective device providing data on the patient’s health state. That means if the transmission relay device, e.g., a patient remote (PR), is connected to the stimulator for less than 16 days per month and/or the system is incapable of capturing the required monitoring data, the monitoring and/or therapeutic measures based thereon may become inaccurate and inefficient.

Patent application WO 2022/207430 Al titled “System and method for data interrogation and/or remote programming of a medical device” describes a system comprising at least one medical device, a remote monitoring server, at least one patient remote device and at least one health care professional remote device, wherein the system is configured such that for programming and/or interrogation of one chosen medical device. The system and method described herein are related to the device system and general processes for remote programming described in that prior art publication.

Realistically, a high reliability is a significant contributor to user (i.e., clinician, clinical representative and/or patient) acceptance of respective systems and devices, and to user satisfaction, and is therefore critical for treatment efficiency. However, many known solutions are unreliable, can only achieve low data transmission success rates, and/or require patient engagement which is error-prone and cannot meet high medical standards. As currently available systems and devices cannot guarantee sufficient reliability, clinicians mostly prefer costly face-to-face monitoring, which comes along with increased effort for clinicians and patients...

Hence, there is still a need to further improve solutions, including devices, systems, methods, and computer programs, for remote programming of medical devices and/or data transmission from and/or to medical devices, e.g., IMDs.

The above need is at least in part met by the various aspects described herein.

An aspect of the present invention relates to an apparatus for transmitting data to and/or receiving data from an implantable medical device (IMD). Said apparatus comprises means for regularly transmitting data to and/or receiving data from the IMD, means for detecting an irregularity in transmitting and/or receiving data, and means for providing an alert based on the irregularity. Such apparatus yields an advantageous alert mechanism that may improve reliability of a whole system for transmitting data to and from IMDs, as irregularities may be detected and communicated accordingly. This allows resolution of such irregularities before they can severely impair the purpose of the data transmission, e.g., patient monitoring by a clinician. This may also improve success chances of medical treatments, the handling of systems comprising such apparatuses and/or IMDs, and/or clinician and patient satisfaction.

The invention may be used in multiple areas of medical device applications, e.g., spinal cord stimulation (SCS), cardiac rhythm management (CRM), and many other medical fields that utilize an implanted medical device, e.g., deep brain stimulation (DBS), occipital nerve stimulation (ONS), trigeminal nerve stimulation (TNS), vagal nerve stimulation (VNS), phrenic nerve stimulation, gastric electrical stimulation, and sacral nerve stimulation (SNS). The IMD described herein may, e.g., be the respective medical implant performing the respective function according to any of the above applications.

The apparatus may, e.g., comprise a health care professional/clinician remote device (CP), a server, and/or a PR. One or more CPs, one or more servers, one or more PRs, and/or one or more IMDs may be connected to one another as described herein. E.g., a bidirectional continuous communication connection may be established and maintained such as to directly connect at least one CP with a respective server and to connect one or more IMDs with said server via at least one PR such that the PR is a link between the server and at least one IMD. In such configuration, the server may act as a central node connecting one or more device with any of the apparatuses mentioned herein with one another. For example, there may also be more than one server. Each of the mentioned apparatuses may correspond to the apparatus of the above aspect.

In an example, a system is proposed comprising at least one IMD, a server, at least one PR and at least one CP, e.g., a remote device for a clinician, wherein the system is configured for programming and/or interrogation of the IMD, for example, by a clinician. E.g., one CP may establish a communication session connecting the CP via the server and the PR with the IMD, such as to include a first bidirectional communication connection of the CP and the server. Further, said mechanism may comprise automatically triggering the server to establish a second bidirectional communication connection of the server and the PR corresponding to the IMD, and to establish a third bidirectional communication connection of the PR and the IMD. The system may thus be configured to provide real-time remote programming and/or interrogation of the IMD using the CP via the server and the corresponding PR, and to maintain the first, second and third communication connections as continuous communication connections (i.e., the connections stay open and active). In one exemplary embodiment, the continuous communication connections may be maintained until a close signal is sent from the CP to the IMD via the server and the corresponding PR.

For example, one or more clinicians may be provided with data from the same IMD via such system: A clinician-triggered request for the interrogation of the IMD can be initiated remotely from one or more CPs, e.g., (1+N) CPs (where N is an integer; N = 0, 1, 2, ...). The data collected by the interrogation can then, e.g., be viewed remotely at the interface of (1+N) CPs presenting data to the attending clinician(s). The data presented may be collected from (1+N) data reporters. The data presented may be a combination of subjective and objective data, and the data presented may be a combination of current and historical data.

Such system may have the ability to monitor, e.g., transmission frequency, and to set triggers to alert the clinic or designee that patient data is at risk of failing to achieve remote monitoring goals. Clinicians can then act to debug and resolve issues causing the low monitoring transmission rate. Settings for this type of alert may be user-configurable, based upon the needs of the clinic or patient. Assuring that enough data is received from a patient helps achieve the goal of improved patient care. Configuring the alert may, e.g., comprise selecting which information on the underlying error and/or irregularity may be outputted and/or to which devices the alerts may be sent (e.g., to a mobile phone, a computer, an IMD- specific remote device, a smart watch and/or other wearables, etc. of, e.g., the patient, the clinician and/or a technician).

The proposed system may generally have the advantage that communication is provided in real time, via individual system devices automatically interacting in order to facilitate a continuous data stream. The system described further provides clinicians continuously with up-to-date information about their patients while the patients are going about their daily lives. The reduced latency and increased availability of longitudinal data (e.g., data that tracks the same sample at different points in time) provided is expected to result in improved quality of care for the patients and efficiency in the clinic workflow.

One or more than one (e.g., all) apparatuses of such system may be configured to provide alerts as described herein.

The means for regularly transmitting data to and/or receiving data from the IMD may, e.g., be configured to transmit and/or receive data periodically and/or at predetermined times, e.g., once per month, once per week, once per day, every 12 hours, every hour, etc. The regularity may be reprogrammable, e.g., via the CP, which may allow a clinician to change the rate at which data are transmitted from the IMD to the CP, e.g., via the continuous communication connection described herein.

In general, it is possible to gather data in both “push” and “pull” modes, thus increasing the scenarios under which data is captured: In a first example, data may continuously be pushed from the IMD to the server whenever the PR is in operation and the PR has connectivity. In a second example, data can also be “pulled” from the IMD while it is operating in a Remote Monitoring (RM) or Remote Programming (RP) session. The RM or RP mode is used for triggering a real-time interrogation of the patient’s medical device current data, for remote analysis of current and historical patient data, and for remote communication to the medical device, all done during a continuous session between the clinician, the patient and the IMD.

The means for detecting an irregularity in transmitting and/or receiving data may, e.g., detect when data are not being received by the apparatus at the time they are expected, when the continuous communication connection cannot be maintained, and/or one or more apparatuses of the system are not accessible/are disconnected from any other apparatus of the system. The means may also be configured to detect an irregularity in terms of data not being transmitted or being transmitted incompletely, and an alert may be provided based thereon. The means for providing an alert based on the irregularity may, e.g., inform any apparatus of said system on any of the irregularities described herein. E.g., a first apparatus may expect to receive data from a second apparatus. If, in this example, said data transmission fails, the first apparatus may provide an alert based on noticing that no data or incomplete data were received and/or the second apparatus may provide an alert based on not being able to transmit the data (fully or in part). The alert may in some examples be sent to a device other than that from which or to which the data transmission is to occur.

In an example, the means for providing the alert may comprise means for outputting the alert, and/or the means for providing the alert may comprise means for forwarding the alert to a server, a CP, and/or a PR, as described herein.

Communicating such alerts may advantageously provide a system in which irregularities are detected and the involved clinicians, patients, technicians, etc. may be informed quickly, directly, and/or reliably. This also allows users of devices that are not directly but only indirectly affected by the respective irregularity to respond to the irregularity and, e.g., to resolve it.

For example, one apparatus may forward the alert to a server, a CP, and/or a PR, wherein the device the alert is forwarded to is not the IMD associated with the irregularity, i.e., the IMD that could not successfully transmit its data to a target apparatus via a continuous communication connection as described herein.

In an example, the alert comprises at least one of: information on the irregularity and one or more user instructions to resolve the irregularity.

Alerts comprising such information and/or instructions provide a suitable tool to communicate the relevant information to those users that may quickly respond to the underlying error causing the irregularity in data transmission. For example, the system could process a workflow by which the patient is actively involved in the connectivity resolution, e.g., by triggering a text message/call asking the patient to turn on/debug the WLAN or GPS transceiver (this may be preferable in terms of patient privacy). An escalation scheme could also be used, e.g., first text the patient to alert them of the connectivity issue, then an attempt to call them (via robocall or support staff) if the problem does not resolve within a predetermined period of time.

In an example, the alert may comprise one or more machine instructions that automatically change the internal programming of the apparatus and/or remotely changes the programming of a server, a CP, a PR, and/or the IMD.

Such automatic response to the underling error causing the irregularity in data transmission may increase the speed at which said error may be resolved. It may further reduce the need for human intervention. It is especially advantageous to not rely on patient intervention as patients are typically untrained and/or not able to perform the necessary tasks, e.g., due to their possibly poor condition. Therefore, this solution may save time, work and/or costs and improve reliability of the system and/or each individual apparatus of the system, especially in terms of their mutual communication.

The automatically-induced changes may, e.g., comprise a re-start of the respective device and/or the Bluetooth/Wi-Fi connection and/or any other connection protocol the respective device may be using to establish and maintain the continuous communication connection described herein.

For example, the machine instructions may comprise one or more instructions for pulling missing data from the IMD by sending a request for the missing data to the IMD.

This may provide an option to retrieve data from the IMD which may otherwise be lost. Thus, reliability of the system and/or the involved apparatuses may be increased, and efficiency of the patient monitoring may be increased. This may especially be advantageous in a system that typically transmits data in a “push” mode, which may be complemented by pulling data as described herein when necessary. Executing an automatic “pull” may especially be suited in scenarios in which the patient does not respond to prior approaches to contact the patient, as described herein. Generally, the functionalities described herein in reference to the apparatus may also be implemented (in full or partly) in the IMD of the respective system.

According to a further aspect of the invention, an IMD is provided. Said IMD comprises means for regularly determining physiological data sets, means for storing the physiological data sets and means for regularly transmitting the physiological data sets. Therein, the means for storing is configured to, if its storage limit is reached, store a most recently determined data set by replacing an older data set. The IMD may, e.g., be configured to be part of a system as described herein, e.g., in reference to the respective apparatus(es).

IMDs with such storing protocol may be advantageous in situations where implants have only limited storage due to limitations in terms of available space and energy consumption that large data storage may bring along.

To handle scenarios in which connectivity links between system components are temporarily unavailable, remote monitoring data storage (i.e., caching of multiple measurements of the same data type) can be employed. Specifically: IMD means for storing can be configured to store more than one measurement of the same data type, rather than overwriting a measurement, in the event that the (e.g., Bluetooth) connection between IMD and PR is unavailable. At the time the connection becomes available and/or at the next scheduled IMD transmission time, the PR may be able to receive and process all cached IMD data. Analogously, PR means for storing can be configured to store more than one measurement of the same data type, rather than overwriting a measurement, in the event that the network connection is unavailable. At the time that the network connection becomes available, the server is able to receive and process all cached PR data. In the event of memory limitations, the IMD and/or the PR may be configured to intelligently delete data points such that a historical trend is still available at the time of connectivity restoration. For example, if memory capacity is exceeded after 10 days of storage, the system would delete in a hierarchical order such that the overall trend is still retained. For example, the means for storing may automatically delete data storage once the critical content is handed off to the next node in the system. In an exemplary embodiment, the means for storing may be configured to select the older data set based on a predetermined algorithm. The "means for storing" is also referred to below as "storing means".

Such algorithm specifically goes beyond a mere random selection of the dataset to be deleted/replaced by the most recent data set. Such algorithm may be adjusted to the specific requirements of the monitoring session of the patient, the device, the preferences of the involved clinician, etc. This improves the reliability of the system and all involved apparatuses in view of the specific preferences and/or requirements in that case.

In some examples, the predetermined algorithm may be different from a “first in, first out” (FIFO) algorithm. (FIFO (the first in is the first out) relates to organizing the manipulation of a data structure (e.g., a data buffer) where the oldest (first) entry is processed (in this example, deleted) first.) This yields the advantage that not deleting the oldest data set stored by the means for storing means that the total time span between the oldest data set and the most recent data set covers a longer time than would be achieved by an IMD operating its storage means by a FIFO algorithm. Generally, monitoring patient data over a longer time span may help the attending clinician to identify trends and patterns associated with the patient’s health state more easily and/or accurately und thus improve treatment.

In an example, the means for storing may be configured to select the older data set such that a predetermined minimum number of data sets per predetermined time interval remains stored on the means for storing.

This may, e.g., advantageously ensure that the number of data sets per month or any other suitable period for patient monitoring does not fall below a certain threshold that may be seen as necessary for sufficient assessment of the patient’s health state (over time).

For example, the means for storing may be configured to ensure that data sets of at least 16 days per month are stored unless this is impossible. E.g., when the IMD fails to transmit its data sets for several subsequent days during the last days of one months and the first days of a second subsequent month, it may be preferred to replace data sets of the second month’s such as to ensure to not fall below the minimum number of data sets (e.g., 16) in the first month, rather than deleting data from the second month, since a sufficient number of data might be transmitted in the coming days.

In a further example, each data set (labeled by the index i) may comprise a logic index xi, preferably a time stamp. Further, replacing an older (stored) data set may in this example comprise choosing the older data set to be replaced based at least in part on the logical index of the older data set and possibly of one or more further data sets stored by the storing means.

Such logic index xi may advantageously serve as a means to quantitively assess the data sets currently stored by the means for storing for finding a data set to be replaced. The logic index may, e.g., be an integer (e.g.: (0,) 1, 2, ...) labelling the data sets by increasing the integer by one from one data set to the next, a time stamp which may be a date, a time, and/or a data and a time on that date.

In a further example, the storing means may further be configured to choose the older data set (to be deleted) such as to: minimize the maximum absolute difference |xi - xj| between any pair of subsequent data sets i and j stored on the storing device after replacing and/or maximize the maximum absolute difference | Xmax “ Xmin | between the highest logic index Xmax and the lowest logic index x_min of all data sets stored on the storing device after replacing. Subsequent data sets may be understood as two data sets which, considering all data sets which are stored by the means for storing at that moment, follow one another as indicated by the logic index xi which indicates a distinct succession of the stored data sets.

This advantageous combination may ensure that at the same time the (time) interval between two data sets is as short/small as possible and, at the same time, the total time span covered by all data sets stored by the means for storing is as long as possible. This may improve the reliability of the system such that, even in scenarios when data transmission is impaired persistently, the available data sets provide sufficient data points per time period for the clinician to gain insights into the development of the patient during that time. In an example, maximizing the maximum absolute difference | Xmax “ Xmin | between the highest logic index x_max and the lowest logic index x_min of all data sets stored on the storing device after deleting may be given a higher priority than minimizing the maximum absolute difference |xi - xj| between any pair of subsequent data sets i and j stored on the storing device after deleting. This may become relevant when otherwise there would occur a conflict between the two aims of the algorithm.

For instance, according to an example, the storing means is configured to store one set of data per day, wherein the maximum storage capacity amounts ten data sets. After day ten, assuming a continuous dysfunctional data transmission to the remote monitoring server, the storage capacity reaches its limit and comprises the data sets of the days 1 to 10. In that case, the maximum absolute difference |xi - xj| between any pair of subsequent data sets i and j stored on the storing device amounts 1, and the maximum absolute difference | Xmax “ Xmin | between the highest logic index x_max=xio and the lowest logic index x_min=xi of all data sets amounts 9. On day 11, a new data set is incoming, and the storing means is required to replace one data set. In that case, the storing means is configured to either la) prioritize the premise of minimizing the maximum absolute difference |xi - xj| between any pair of subsequent data sets i and j stored on the storing device after replacing. In that case, the storing device would delete the data set from day 1, and store the data set of day 11, such that the storing device comprises the data sets of days 2, 3, 4, 5, 6, 7, 8, 9, 10, 11. By doing so, the maximum absolute difference |xi - xj| between any pair of subsequent data sets i and j stays 1; or, alternatively lb) maximize the maximum absolute difference |x_max - xmin| between the highest logic index Xmax and the lowest logic index x_min of all data sets stored on the storing device after replacing. In that case, for instance the data set of day 2 can be deleted, such that the storing device comprises the data sets of 1, 3, 4, 5 ,6, 7, 8, 9, 10, 11. By doing so, the maximum absolute difference |x_max - x_min| between the highest logic index xmax=xn and the lowest logic index x_min=xi of all data sets is at a maximum of 10.

On day 12, the storing means is required to replace another one data set. In that case, pursuant to the logic above, the storing means is configured to either

2a) prioritize the premise of minimizing the maximum absolute difference |xi - xj| between any pair of subsequent data sets i and j stored on the storing device after replacing. Starting with the data set from subcase la), the storing device would delete the data set from day 2, and store the data set of day 12, such that the storing device comprises the data sets of days 3, 4, 5, 6, 7, 8, 9, 10, 11, 12. By doing so, the maximum absolute difference |xi - xj| between any pair of subsequent data sets i and j stays 1. Starting with the data set from subcase lb), the storing device would delete the data set from day 1, and store the data set of day 12, such that the storing device comprises the data sets of days 3, 4, 5, 6, 7, 8, 9, 10, 11, 12. By doing so, the maximum absolute difference |xi - xj| between any pair of subsequent data sets i and j is also 1. Or, alternatively

2b) maximize the maximum absolute difference |x_max - between the highest logic index x_max and the lowest logic index x_min of all data sets stored on the storing device after replacing. Starting with the data set from subcase la), the data set of day 3 can be deleted, such that the storing device comprises the data sets of 2, 4, 5 ,6, 7, 8, 9, 10, 11, 12. By doing so, the maximum absolute difference |x_max - Xmin| between the highest logic index x_max=xi2 and the lowest logic index x_min=x2 of all data sets is at a maximum of 10. Starting with the data set from subcase lb), the data set of day 4 can be deleted, such that the storing device comprises the data sets of 1, 3, 5 ,6, 7, 8, 9, 10, 11, 12. By doing so, the maximum absolute difference |x_max - Xmin| between the highest logic index x_max=xi2 and the lowest logic index x_min=xi of all data sets is at a maximum of 11.

The logic described for replacing and storing data sets can be continued for any additional number of data sets.

An exemplary embodiment of the IMD may further comprise means for providing an alert, based at least in part on a predetermined fraction of the storage limit being reached.

Such alert may be configured as described herein in reference to the apparatus of the system. In synergy with the advanced storing mechanism of the IMD, the reliability of the IMD is improved even further.

For example, means for providing an alert may be configured to provide the alert when (more than) 10%, 20%, 30%, 40%, 50%, 60%, 70%, 80%, 90% of the storage limit is reached. Especially, an alert may be provided when 100% of the storage limit is reached. The means for providing the alert may be configured to provide an alert at multiple storage thresholds, e.g., one at 50%, one at 90% and/or one at 100% allocation of the storage limit.

According to a further aspect of the invention, a system comprising at least one apparatus and at least one IMD, both as described herein, is provided.

By combining the advantages of the at least one apparatus and/or at least one IMD, respectively, the reliability may be increased even further. The synergy between the functionalities of the components of the system provides different responses to possible irregularities in data transmission such that a large variety of potential errors and/or irregularities may be compensated for such that the system may run reliably:

The system may yield an increased availability of data access leading to, e.g., improved treatment outcomes via improved optimization of patient therapy and improved clinic workflows. Further, travel demands on patients to achieve desired care may be reduced. So- called pain “wind-up” that can occur when care for new pain vectors cannot be quickly provided may be reduced as e.g., increased communication reliability leads to better/earlier intervention, possibly even before the pain cycle causes physiologic remodeling. Regarding the operation of the clinic, the invention may yield an increased availability of data access leading to improved clinic workflows: Less time may be spent waiting for data to be received and data received is more complete, therefore improving the diagnosis and decision-making process. Further, remote patient monitoring may be facilitated, leading to increased ability for cost- and work-efficient treatment. Data transmission pathways may be as seamless, automatic and reliable as possible, increasing satisfaction of clinicians and patients.

According to a further aspect of the invention, a method executed by apparatus for transmitting data to and/or receiving data from an IMD is provided. The method comprises the steps of regularly transmitting data to and/or receiving data from the IMD, detecting an irregularity in transmitting and/or receiving data, and providing an alert based on the irregularity. The method brings along the same advantages described herein in reference to the respective apparatus, i.e., especially increasing the reliability of the process of remote patient monitoring.

According to a further aspect, a method to be executed by an IMD is provided. The method comprises the steps of regularly determining physiological data sets, storing the physiological data sets by a means for storing, regularly transmitting the physiological data sets, and, if a storage limit of the means for storing is reached, storing a most recently determined data set by replacing an older data set.

The method brings along the same advantages described herein in reference to the respective IMD, i.e., especially increasing the reliability of the process of remote patient monitoring.

According to a further aspect, to handle scenarios in which connectivity links between system components are temporarily unavailable, remote monitoring data storage (i.e., caching of multiple measurements of the same data type) may be employed. Specifically: IMD means for storing may be configured to store more than one measurement of the same data type, rather than overwriting a measurement, in the event that the (e.g., Bluetooth) connection between the IMD and the patient remote (PR) is unavailable. At the time the connection becomes available and/or at the next scheduled IMD transmission time, the PR may be able to receive and process all cached IMD data. Analogously, PR means for storing may be configured to store more than one measurement of the same data type, rather than overwriting a measurement, in the event that the network connection is unavailable. At the time that the network connection becomes available, the server (e.g. the remote monitoring server, RMS) is able to receive and process all cached PR data. In the event of memory limitations, the IMD and/or the PR may be configured to intelligently delete data points such that a historical trend is still available at the time of connectivity restoration. For example, if memory capacity is exceeded after more than 5 days of storage, in particular after 10 days of storage, the system would/may delete in a hierarchical order such that the overall trend is still retained. For example, the means for storing may automatically delete data storage once the critical content is handed off to the next node in the system. The methods herein may be computer-implemented methods and a computer program may be provided with instructions according to the steps of the methods. Further, any functionality described herein in reference to the apparatus, the IMD, and/or the system may be implemented as steps of a method and/or as instructions of a respective computer program, and vice versa.

Fig. 1 shows one embodiment of the inventive system and the steps establishing the continuous communication connection between the components of the system;

Fig. 2 depicts another sketch of the inventive system;

Fig. 3a shows an exemplary scenario in which the continuous communication connection between the health care professional remote device and the remote monitoring server is lost;

Fig. 3b shows an exemplary scenario in which the patient remote is inactive;

Fig. 3c shows an exemplary scenario in which the continuous communication connection between the patient remote device and the medical device is lost;

Fig. 4 shows exemplary entries (data sets) in means for storing in a scenario in which the storage limit is reached for consecutive days.

In the following, exemplary embodiments of the inventive system will be explained in detail. The exemplary embodiments are explained with regard to medical devices in the form of spinal cord stimulation (SCS) devices and a server (in the following examples a remote monitoring server (RMS)) and with regard to remote programming which may include data interrogation but may comprise, e.g., further or alternative devices, servers, etc. Fig. 1 shows the components of the system, namely the RMS 1, at least one CP 3, at least one PR 5, and at least one medical device, for example an SCS device, 7. For further information and for the properties with regard to the system components 1, 3, 5, 7 it is referred to the respective explanations herein.

An overview of an exemplary remote programming (RP) method may be derived from Fig.

1 comprising, e.g., the following steps. At first, the clinician triggers the communication session at their user interface (CUI) at the CP 3 by a session request 11 which is sent to the RMS 1. Then, the RMS 1 initiates a bidirectional continuous communication connection 14 with the PR 5 based on a handshake 12 with the PR 5. In the next step, the PR 5 initiates a bidirectional communication connection 14 with the medical device 7 based on a handshake 13 process, as well. Then, the medical device 7 sends a response to the CP 3 via the PR 5 to RMS 1 to CP 3 communication chain which is denoted in Fig. 1 with reference number 14. Now a continuous bidirectional communication connection 14 is established between the CP 3 and the medical device 7 with all components now connected in real-time. In the example of Fig. 1, The CP 3 is in direct connection with only the RMS 1. The RMS 1 is, besides the CP 3, also in direct connection with the PR 5. The PR 5 is not only directly connected to the RMS 1 but also to the medical device, e.g., an IMD 7. Thus, also between CP 3 and RMS 1 a bidirectional continuous communication connection 14 is established, in this case by means of the session request 11. All the mentioned bidirectional communication connection 14 can also be established in other ways than by means of the session request 11. Upon completion of the use case, the session initiator (e.g., the clinician) indicates at CP 3 that the session is complete and signals the other components to release their handshakes (step 15). Throughout this process, only one handshake 11, 12, 13 is required between adjacent components, each communication channel stays open and steady until a closing message 15 is sent which closes all connections 14 between the components of the system as described herein.

One or more (e.g., all) steps in the sequence of communications may require a “handshake” process that may ensure cybersecurity and provide automatic data persistence, communication persistence and communication repetition to ensure that the communication between each component is completed. In this invention the use of single, serial handshakes between each component is significantly reduced. Each component 1, 3, 5, 7 in the chain of connected subsystems 1, 3, 5, 7 is designed to autonomously maintain a continuous connection 14 to its neighbors, via an on-going session that persists for the duration of the communication process i.e.: IMD 7 and PR 5 may maintain a Bluetooth connection while they are in proximity. PR 5 and RMS 1 maintain a TCP/IP network connection over the Internet while mobile networks are available. CP 3 and RMS 1 maintain a TCP/IP network connection over the Internet while mobile networks are available, and the clinician is in proximity to the CP 3. A feedback loop may exist between devices to maintain a closed loop with the devices adjacent to it in the communication pathway, to proactively assess the status of the communication process and to automatically and immediately process information when received. Each link transmits new data to the next hop in chain as soon as new data is available, thereby reducing transmission latency to (nearly) zero. In case of connectivity loss, any system component may send new buffered data as soon as connectivity to the neighbor is restored. Each system component may maintain a data buffer of sufficient depth to sustain occasional loss of connectivity, and to allow the transmission of large datasets. Each link may release local data storage as soon as the neighbor has received the data payload. The processes described herein may be based upon standard, off-the-shelf communication protocols (e.g., TCP/IP). Device specifications used may be specific and optimized for each medical device application. For example, the IMD 7 can adjust its data sampling rate based upon the communication bandwidth available to it, the PR 5 can buffer its data transmission to adjust for bottlenecks downstream of it, etc. The system may be designed such that no user adjustment is required during the communication process. Each component 1, 3, 5, 7 in the system can automatically optimize its behavior within a proscribed range to match the current communication capability.

In one exemplary embodiment the following protocols may be used to establish and/or maintain the continuous communication connection:

- Medical device 7 to PR 5: Bluetooth Low Energy (BLE)

PR 5 to public communication network(s) (PCN), e.g., 4G LTE, Wi-Fi 802.11

- PR 5 to RMS 1 : TCP/IP

- RMS 1 to public network(s): VPN

- RMS 1 to CP 3: TCP/IP Accordingly, the system components 1, 3, 5, 7 of this exemplary embodiment and other embodiments may comprise interface modules to communicate via mobile wireless networks (e.g. SMS connection 14), GPRS data connection 14, UMTS data connection 14, and/or LTE data connection 14), virtual private network(s) or dedicated line(s), internet and local networks via Ethernet or WLAN, electronic patient/case files (electronic medical records) via HL 7 v2 or v3 or similar. Further, suitable communication standards, e.g., TLS+TCP/IP, SSL+TCP/IP, or ebXML may be used.

In addition to patient data storage at any component of the system, a subset of data may be copied to a data warehouse to support internal business functions such as technical forensics, quality monitoring, and clinical studies, i.e., a “data tap”. Though this data warehouse may not be directly accessible by users (e.g. clinician, clinical representative and/or patient), it can serve as a back-up to the data stored in the system.

Generally, the RMS 1 may establish and/or hold a bidirectional continuous communication connection 14 with one or more CPs 3 once or repeatedly at the same time and/or at different times. Analogously, the RMS 1 may establish and/or hold a bidirectional continuous communication connection 14 with one or more PRs 5 once or repeatedly at the same time and/or at different times. In such examples, the RMS 1 may act as a central communication node.

In other examples, any functionality of any of the components 1, 3, 5, 7 may be transferred to any of the other components 1, 3, 5, 7 described herein. In another example, the RMS 1 may, e.g., establish and/or hold a bidirectional continuous communication connection 14 with one or more medical devices 7 directly, additionally or alternatively to a connection via a PR 5 as described herein.

Fig. 2 contains a different visualization of a whole exemplary inventive system. The RMS 1 comprises a Couchbase server 21 as central data repository to store data. Additionally, the RMS 1 comprises a Couchbase Sync Gateway 22 for synchronization and communication with CP 3 and PR 5. In the example of Fig. 2, the system further comprises External Push Notification Services 23 (e.g., Microsoft Azure, Google Firebase Cloud Messaging) in order to notify the CP 3 or the PR 5 to pull data from the RMS 1 via push notifications. For that, the RMS 1 sends, e.g., a push notification request to the external push notification services 23. In the example of Fig. 2, the arrows 25 represent Internet connections, the arrow 26 a BLE connection and the arrows 27 local network connections (e.g., LAN connections). The exemplary RMS 1 further comprises a certificate and key management system (CKMS) 28 which is used to decrypt the data received from the at least one medical device 7. In one embodiment the External Push Notification Services 23 may be integrated in the RMS 1. Further, in order to communicate with the Couchbase server 21 of the RMS 1 the exemplary CP 3 and the PR 5 each comprises a Couchbase mobile application 29.

Following examples describe exemplary scenarios in which the continuous communication connection 14 cannot be sustained between all components 1, 3, 5, 7 of the system and indicates examples of alerts that may be triggered by such errors which may cause irregularities in data transmission.

Fig. 3a shows an exemplary scenario in which the continuous communication connection 14 between the CP 3 and the RMS 1 is lost. The continuous communication connection 14 between the RMS 1 and the CP 3 may, e.g., be a TCP/IP connection. In the example of Fig. 3a, the connection loss separates the CP 3 from the remaining components of the system, namely the RMS 1, the PR 5, and the medical device 7 which may still communicate with one another.

The error 15, namely the continuous communication connection 14 loss between the CP 3 and the RMS 1 may be detected by any of the components 1, 3, 5, 7. In the example of Fig. 3a, the CP 3 and the RMS 1 detect that error/irregularity 15 and provide an alert 16 to CP 3 and/or to PR 5. In the shown example, the CP 3 provides the alert to be outputted by itself, e.g., to inform the operating clinician about the error/irregularity 15. The clinician might also receive instructions how to resolve such error/irregularity 15, e.g., a suggestion to restart the CP 3 or to change any setting(s) of the CP 3. Additionally or alternatively, the respective alerts 16 created at the RMS 1 and the CP 3 may induce an automatic response there and/or in any device the alert 16 is transmitted to, e.g., aiming at resolving the error/irregularity 15. Corresponding automatic response instructions may be similar or different than those exemplary instructions that the clinician may receive. Further, the RMS 1 detects said error/irregularity 15 and provides an alert 16 and transmits it to the PR 5, e.g., for outputting of an alert message to inform the patient using the PR 5 about the error/irregularity 15 and that the respective clinician may currently be not available.

Fig. 3b shows an exemplary scenario in which the PR 5 is inactive. The PR 5 being inactive, e.g., because it was switched off or ran out of battery, disconnects the PR from both, the RMS 1 and the medical device 7. The continuous communication connection 14 is thus only maintained between the RMS 1 and the CP 3. In the example of Fig. 3b, the RMS 1 detects that error/irregularity 15, provides an alert 16 and transmits it to the CP 3 to be outputted there, e.g., to inform the operating clinician about the error/irregularity 15. Again, the clinician may optionally receive additional instructions how to resolve such error/irregularity, e.g., a suggestion to contact the patient using the PR 5, e.g., instructing them to recharge or restart the PR 5.

Fig. 3c shows an exemplary scenario in which the continuous communication connection 14 between the patient PR 5 and the medical device 7 is lost. In the example of Fig. 3c, the RMS 1 detects the error/irregularity 15 due to the connection loss between the PR 5 and the IMD 7. Based thereon, it provides an alert 16 which is transmitted to both the CP 3 and the PR 5, where they are outputted to the clinician and the patient, respectively. Additionally or alternatively, the alert 16 may comprise machine instructions triggering an automatic response to the error/irregularity 15 in the CP 3 and/or the PR 5 aiming to resolve the error/irregularity 15.

Fig. 4 shows exemplary entries (data sets) in a means for storing in a scenario in which the storage limit is reached for consecutive days. It is to be understood that from day 1 to day 9 (not shown), the storage was occupied by one data set per day without transmitting any of the data sets during these days such that, on day ten, the storage limit is reached. On that day, the data sets of days 1 - 10 are stored by the means for storing and no conflict occurred yet, as sufficient storage was available also for the tenth data set. On the eleventh day, the eleventh data set cannot be stored by the means for storing without deleting another data set. To maximize the total time span covered by data sets in the storage, the data set of day two is replaced by the data set of day eleven. On day twelve, the same problem occurs and the data set of day four is replaced by the data set of day 12. Notably, deleting data set 4 (and not 3) kept the time difference between two consecutive data sets at a maximum of two days throughout all data sets stored by the means for storing. In contrast, if the data set of day three would have been replaced, a time difference of three days between day 1 and day 4 would yield a larger maximum time difference between two consecutive data sets. Continuing accordingly on the following days, data set 6 is replaced by data set 13 and data set 8 is replaced by data set 14. The algorithm may continue analogously until connection is restored and all ten data sets stored by the mans for storing at that time may be transmitted and deleted from the means for storing making space for ten new data sets at once.

Claims

Claims

1. An apparatus (1, 3, 5) for transmitting data to and/or receiving data from an implantable medical device (7), IMD, the apparatus (1, 3, 5) comprising: means for regularly transmitting data to and/or regularly receiving data from the IMD (7); means for detecting an irregularity (15) in transmitting and/or receiving data; and means for providing an alert (16) based on the irregularity (15).

2. The apparatus (1, 3, 5) of claim 1, wherein the means for providing the alert (16) comprises means for outputting the alert (16) and/or wherein the means for providing the alert (16) comprises means for forwarding the alert (16) to a server (1), a clinician remote device (3), CP, and/or a patient remote device (5), PR.

3. The apparatus (1, 3, 5) of any of claims 1 or 2, wherein the alert (16) comprises at least one of: information on the irregularity (15) and a user instruction to resolve the irregularity (15).

4. The apparatus (1, 3, 5) of any of claims 1-3, wherein the alert (16) comprises a machine instruction that automatically changes the internal programming of the apparatus (1, 3, 5) and/or remotely changes the programming of a server (1), a CP (3), a PR (5), and/or the IMD (7).

5. The apparatus (1, 3, 5) of claim 4, wherein the machine instruction comprises an instruction for pulling missing data from the IMD (7) by sending a request for the missing data to the IMD (7).

6. An implantable medical device (7), IMD, comprising: means for regularly determining physiological data sets; means for storing the physiological data sets; means for regularly transmitting the physiological data sets; wherein the means for storing is configured to, if its storage limit is reached, store a most recently determined data set by replacing an older data set.

7. The IMD (7) of claim 6, wherein the means for storing are configured to select the older data set based on a predetermined algorithm.

8. The IMD (7) of claim 7, wherein the predetermined algorithm is different from a first in, first out, FIFO, algorithm.

9. The IMD (7) of any of claims 6 - 8, wherein the means for storing are configured to select the older data set such that a predetermined minimum number of data sets per predetermined time interval remains stored on the means for storing.

10. The IMD (7) of any of claims 6 - 9, wherein each data set i comprises a logic index xi, preferably a time stamp; and wherein replacing an older data set comprises choosing the older data set based at least in part on the logical index of the older data set.

11. The IMD (7) of claim 10, wherein the means for storing are further configured to choose the older data set such as to:

- minimize the maximum absolute difference |xi - xj | between any pair of subsequent data sets i and j stored on the storing device after replacing; and/or

- maximize the maximum absolute difference |x_max - between the highest logic index x_max and the lowest logic index x_min of all data sets stored on the storing device after replacing.

12. The IMD (7) of any of claims 6 - 11, further comprising means for providing an alert, based at least in part on a predetermined fraction of the storage limit being reached.

13. A system comprising at least one apparatus (1, 3, 5) according to any of claims 1 - 7 and at least one IMD (7) according to any of claims 8 - 12.

14. A method, executed by apparatus (1, 3, 5) for transmitting data to and/or receiving data from an implantable medical device (7), IMD, the method comprising the following steps: regularly transmitting data to and/or receiving data from the IMD (7); detecting an irregularity (15) in transmitting and/or receiving data; and providing an alert (16) based on the irregularity (15).

15. A method, executed by an implantable medical device (7), IMD, the method comprising the following steps: regularly determining physiological data sets; storing the physiological data sets by a means for storing; regularly transmitting the physiological data sets; and if a storage limit of the means for storing is reached, storing a most recently determined data set by replacing an older data set.